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Master Table of Contents

Introduction
Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
Proprietary Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
Patent Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Instrument Disclaimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Pictorial Disclaimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Abbott Instrument Warranty . . . . . . . . . . . . . . . . . . . . . . . . iii
Safety Agency Approvals . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv
Trademark Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv
Instrument Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii
Conventions Used in This Manual . . . . . . . . . . . . . . . . . . . xiii
Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xv
Revision Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvi
Revision Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xix

Chapter 1: System Description


Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
System Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Data Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19
Flat Panel Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-23
Flat Panel Display, Rear Components . . . . . . . . . . . . . . . 1-25
Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27
Sample Loader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27
Reagent System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27
Reticulocyte Reagent System . . . . . . . . . . . . . . . . . . . . . . 1-30
Controls and Calibrator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-31
Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-31
Calibrator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-31

Chapter 2: Installation
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Initial Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Package Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Space Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Waste Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

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Printer Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7


Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Ticket Printer Installation Procedure . . . . . . . . . . . . . . . . 2-10
Sample Loader Set Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
Instrument Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15
Relocation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-19

Chapter 3: Principles of Operation


Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-1
Sample Aspiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
Sample Analysis Cycle Overview . . . . . . . . . . . . . . . . . . . . . . . . . .3-5
WBC Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
RBC/PLT Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Reticulocyte Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Hemoglobin Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Results Displayed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Instrument Rinsed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
WBC Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-9
WIC/WOC Interaction . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
WIC Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
WOC Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
WBC Differential Analysis . . . . . . . . . . . . . . . . . . . . . . . . 3-19
WBC Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25
WBC Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-26
RBC/PLT Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-27
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-27
Electrical Impedance Measurements . . . . . . . . . . . . . . . . 3-27
Coincidence Passage Correction . . . . . . . . . . . . . . . . . . . 3-27
RER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
Volumetric Metering . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
RBC/PLT Measurement Process . . . . . . . . . . . . . . . . . . . . 3-29
RBC Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-30
RBC Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-31
Reticulocytes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-32
PLT Measurement Process . . . . . . . . . . . . . . . . . . . . . . . . 3-32
PLT Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-33
Platelet Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-34
Hemoglobin Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-35
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-35
Hemoglobin Measurement Process . . . . . . . . . . . . . . . . . 3-35
HGB Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-36
Operational Messages and Data Flagging . . . . . . . . . . . . . . . . . . . 3-37
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-37
Interfering Substances . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-37
Instrument Fault and Status Messages . . . . . . . . . . . . . . . 3-38
Parameter Flagging Messages . . . . . . . . . . . . . . . . . . . . . . 3-39

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Introduction to WBC Flagging . . . . . . . . . . . . . . . . . . . . . 3-42


Cell Populations and Flagging . . . . . . . . . . . . . . . . . . . . . 3-45
Flagging Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-49
WBC Descriptors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-49
Suspect Parameter Flags . . . . . . . . . . . . . . . . . . . . . . . . . . 3-50
Suspect Population Flags . . . . . . . . . . . . . . . . . . . . . . . . . 3-54
Flagging Diagnostics Screen . . . . . . . . . . . . . . . . . . . . . . . 3-59
Interpretive Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-60
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-63

Chapter 4: System Specification


Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
CELL-DYN 3700SL System Specifications . . . . . . . . . . . . . . . . . . . 4-3
Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Power Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Operational Specifications . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Bar Code Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
CELL-DYN 3700CS System Specifications . . . . . . . . . . . . . . . . . . . 4-9
Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Power Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Operational Specifications . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Combined Specifications for the SL and CS Systems . . . . . . . . . 4-13
Measurement Specifications . . . . . . . . . . . . . . . . . . . . . . . 4-13
Performance Specifications . . . . . . . . . . . . . . . . . . . . . . . 4-15
Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . 4-20
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25

Chapter 5: Operating Instructions


Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Instrument Logbook . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Data Station Program Overview . . . . . . . . . . . . . . . . . . . . . 5-2
Conventions Used in This Manual . . . . . . . . . . . . . . . . . . . 5-5
Menu Flowcharts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Set Up Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13
Date/Time Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14
Patient Limits Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16
Reagent Log Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-19
QC Set Up Menu Soft Key . . . . . . . . . . . . . . . . . . . . . . . . 5-21
Operation Set Up Soft Key . . . . . . . . . . . . . . . . . . . . . . . . 5-43
Units Selection Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . 5-49
Customize Report Soft Key . . . . . . . . . . . . . . . . . . . . . . . . 5-51
Routine Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-67
Run Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-68
Run Screen Soft Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-74
Sample Collection and Handling . . . . . . . . . . . . . . . . . . . 5-87

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Sample Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-89


Instrument Start Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-92
Sample Analysis Using the SL Model . . . . . . . . . . . . . . . . 5-92
Sample Analysis Using the CS Model . . . . . . . . . . . . . . . . 5-99
Using The Work List . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-103
Sample Analysis Using the Work List . . . . . . . . . . . . . . . 5-114
Using The Data Log. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-121
Data Log Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-122
Data Log Set Up Procedures . . . . . . . . . . . . . . . . . . . . . . 5-135
Data Review from the Data Log . . . . . . . . . . . . . . . . . . . 5-140
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-143

Chapter 6: Calibration
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-1
When to Calibrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Open and Closed Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Calibration Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Calibration Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Calibration Procedural Summary . . . . . . . . . . . . . . . . . . . 6-11
Conventions Used in this Chapter . . . . . . . . . . . . . . . . . . 6-11
Calibration Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13
Calibration Menu Flowchart . . . . . . . . . . . . . . . . . . . . . . 6-13
Calibration Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-14
Open Sampler/Closed Sampler Soft Key . . . . . . . . . . . . . 6-15
Print Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15
Main Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16
Enter Factor Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16
Calibration Log Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . 6-18
Auto-Calibrate Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19
Pre-Calibration Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-27
Calibration Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-27
Pre-Calibration Procedures Checklist . . . . . . . . . . . . . . . . 6-29
Auto-Cal Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-33
Auto-Cal Sample Capacity . . . . . . . . . . . . . . . . . . . . . . . . 6-34
Auto-Cal Methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-34
Calibration Requirements for Auto-Cal . . . . . . . . . . . . . . 6-35
Auto-Cal Using Calibrator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-37
Starting Auto-Cal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-37
Entering the Reference Values . . . . . . . . . . . . . . . . . . . . . 6-37
Collecting the Calibration Data . . . . . . . . . . . . . . . . . . . . 6-38
Calibration Factor Calculation . . . . . . . . . . . . . . . . . . . . . 6-40
Determining Which Parameters Need Calibration . . . . . 6-41
Calibrating All Parameters . . . . . . . . . . . . . . . . . . . . . . . . 6-43
Calibrating Individual Parameters . . . . . . . . . . . . . . . . . . 6-44
Completing Open Mode Calibration . . . . . . . . . . . . . . . . 6-44
Auto-Cal Calibration Criteria Worksheet . . . . . . . . . . . . . 6-45

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Auto-Cal Using Whole Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-47


Starting Auto-Cal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-47
Entering the Reference Values . . . . . . . . . . . . . . . . . . . . . 6-48
Collecting the Calibration Data . . . . . . . . . . . . . . . . . . . . 6-48
Calibration Factor Calculation . . . . . . . . . . . . . . . . . . . . . 6-50
Determining Which Parameters Need Calibration . . . . . 6-52
Calibrating All Parameters . . . . . . . . . . . . . . . . . . . . . . . . 6-54
Calibrating Individual Parameters . . . . . . . . . . . . . . . . . . 6-55
Completing Whole Blood Open Mode Calibration . . . . . 6-55
Auto-Cal Calibration Criteria Worksheet . . . . . . . . . . . . . 6-57
Manual Calibration Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-59
Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-60
Manual Calibration Procedure — Open Mode. . . . . . . . . . . . . . . 6-61
Preparing for Manual Calibration . . . . . . . . . . . . . . . . . . 6-61
Determining the Open Mode Mean . . . . . . . . . . . . . . . . . 6-61
Calibration Factor Calculations . . . . . . . . . . . . . . . . . . . . 6-62
Determining Which Parameters Need Calibration . . . . . 6-63
Calibrating the Open Mode . . . . . . . . . . . . . . . . . . . . . . . 6-65
Completing Manual Calibration . . . . . . . . . . . . . . . . . . . 6-66
Manual Calibration Worksheet . . . . . . . . . . . . . . . . . . . . 6-68
Mode To Mode Calibration Overview . . . . . . . . . . . . . . . . . . . . . 6-71
Auto-Cal Mode to Mode Calibration . . . . . . . . . . . . . . . . 6-71
Manual Mode to Mode Calibration . . . . . . . . . . . . . . . . . 6-72
Mode to Mode Calibration Preparation . . . . . . . . . . . . . . 6-72
Closed Mode Calibration Confirmation . . . . . . . . . . . . . 6-72
Mode To Mode Auto-Cal Calibration
(Closed Sampler Only) . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-73
Determining Reference Values . . . . . . . . . . . . . . . . . . . . . 6-73
Starting Auto-Cal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-74
Entering the Reference Values . . . . . . . . . . . . . . . . . . . . . 6-74
Collecting the Calibration Data . . . . . . . . . . . . . . . . . . . . 6-75
Calibration Factor Calculation . . . . . . . . . . . . . . . . . . . . . 6-77
Determining Which Parameters Need Calibration . . . . . 6-78
Calibrating All Parameters . . . . . . . . . . . . . . . . . . . . . . . . 6-80
Calibrating Individual Parameters . . . . . . . . . . . . . . . . . . 6-81
Completing Mode to Mode Calibration . . . . . . . . . . . . . . 6-82
Optional Calibration Confirmation . . . . . . . . . . . . . . . . . 6-82
Mode to Mode Auto-Cal Calibration Criteria Worksheet 6-83
Manual Mode to Mode Calibration (CS or SL) . . . . . . . . . . . . . . 6-85
Preparing for Manual Mode to Mode Calibration . . . . . . 6-85
Determining the Open Mode Mean . . . . . . . . . . . . . . . . . 6-85
Determining the Closed Mode Mean . . . . . . . . . . . . . . . . 6-86
Percent Difference Calculation . . . . . . . . . . . . . . . . . . . . 6-87
Determining Which Parameters Need Calibration . . . . . 6-88
Calibration Factor Calculation . . . . . . . . . . . . . . . . . . . . . 6-90
Calibrating the Closed Mode . . . . . . . . . . . . . . . . . . . . . . 6-90

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Completing Mode to Mode Calibration . . . . . . . . . . . . . . 6-91


Optional Calibration Confirmation . . . . . . . . . . . . . . . . . 6-91
Manual Mode to Mode Calibration Worksheet . . . . . . . . 6-93
Post-Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-95
Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-95
Calibration Backup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-95
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-99

Chapter 7: Quality Control


Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-1
Quality Control Menu Flowchart . . . . . . . . . . . . . . . . . . . . 7-2
Quality Control Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-3
X-B File Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
View QC Log Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8
Quality Control Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15
Running Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15
Westgard® Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-17
X-B Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-20
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-27

Chapter 8: Hazards
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1
Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Warning Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Hazard Information and Precautions. . . . . . . . . . . . . . . . . . . . . . .8-3
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Biohazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Handling and Disposing of Biohazardous Materials . . . . . 8-4
Chemical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Electrical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
Physical and Mechanical Hazards . . . . . . . . . . . . . . . . . . . 8-6
Laser Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11

Chapter 9: Maintenance
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-1
Preventive Maintenance Schedule . . . . . . . . . . . . . . . . . . . 9-2
Analyzer Flow Panel Components Diagram . . . . . . . . . . . . 9-2
Decontamination Procedures . . . . . . . . . . . . . . . . . . . . . . . 9-4
Special Protocols Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-5
Emptying the Transducers . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
Draining the Reagent Reservoirs . . . . . . . . . . . . . . . . . . . . 9-7
Accessing the Maintenance Log . . . . . . . . . . . . . . . . . . . . . 9-8
Accessing the Shear Valve . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9

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Disabling/Enabling the Analyzer . . . . . . . . . . . . . . . . . . . . 9-9


Special Protocols Screen #2 . . . . . . . . . . . . . . . . . . . . . . . 9-10
Maintenance Log Set Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13
Interval Set Up Procedure . . . . . . . . . . . . . . . . . . . . . . . . . 9-15
Update Maintenance Log Procedure . . . . . . . . . . . . . . . . 9-16
Daily Maintenance Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . 9-19
Auto-Clean . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-19
Sample Loader Aspiration Needle . . . . . . . . . . . . . . . . . . 9-21
Closed Sampler Aspiration Needle . . . . . . . . . . . . . . . . . . 9-22
Weekly Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . 9-23
Shear Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-23
Sample Aspiration Peristaltic Pump Tubing . . . . . . . . . . . 9-26
Sample Loader Tray, Racks, and Safety Cover . . . . . . . . . 9-27
Extended Auto Clean . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-28
Monthly Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . 9-29
Reagent Syringes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-29
Analyzer Air Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-32
WOC Transfer Peristaltic Pump Tubing . . . . . . . . . . . . . . 9-33
Extended Auto-Clean . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-35
As Required. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-37
10-mL Reagent Syringe . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-37
Aperture Plates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-39
Hemoglobin Flow Cell Manual Cleaning . . . . . . . . . . . . . 9-43
Unclogging the Open Sample Aspiration Probe . . . . . . . 9-45
Bar Code Reader Window . . . . . . . . . . . . . . . . . . . . . . . . . 9-46
Flushing the “Y” Fitting — Open and Closed Modes . . . . 9-47
Special Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-51
Closed Sampler Tube Retainer Adjustment
(CS System Only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-51
Preparation for Inactivity or Shipping . . . . . . . . . . . . . . . 9-52
Repackaging for Shipment . . . . . . . . . . . . . . . . . . . . . . . . 9-54

Chapter 10: Troubleshooting


Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Diagnostics Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3
Diagnostics Menu Flowchart . . . . . . . . . . . . . . . . . . . . . . 10-4
Troubleshooting Guide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-27
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-27
Troubleshooting Procedures . . . . . . . . . . . . . . . . . . . . . 10-29
Replaceable Components . . . . . . . . . . . . . . . . . . . . . . . . 10-32
List of Symptoms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-38
Symptom Identification and Resolution . . . . . . . . . . . . 10-39
List of Messages and Fault Conditions . . . . . . . . . . . . . . 10-66
Messages and Fault Conditions . . . . . . . . . . . . . . . . . . . 10-68

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Master Table of Contents

Chapter 11: Printers


Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
Routine Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3
Graphics Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3
Ticket Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3
Maintenance and Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . 11-5
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5

Chapter 12: Sample Loader


Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
Bar Code Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3
CELL-DYN Bar Code Labels . . . . . . . . . . . . . . . . . . . . . . . 12-3
CELL-DYN Q Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3
Bar Code Label Placement . . . . . . . . . . . . . . . . . . . . . . . . 12-3
Sample Loader Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5
Main Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5
Tower Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-7
Operating Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-9
Functional Description . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-9
Function Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-12
Routine Operating Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . 12-15
Operating Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-15
Other Chapters to Reference . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-17
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-17
Set Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-17
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-17

Chapter 13: Veterinary Package


Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-1
Principles of Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-3
The Animal Catalog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-3
Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-5
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-5
Precision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-5
Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-6
Linearity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-7
Carryover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-7
Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-8
Operating Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-9
Vet Package Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-10
Routine Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-21
Run Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-21
Selecting the Animal . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-22

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Master Table of Contents

Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-27
Procedure: MCV or MPV Calibration . . . . . . . . . . . . . . . 13-28
Pre-Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . 13-28
Determining the Calibration Factors for MCV and MPV 13-29
Entering the Calibration Factor . . . . . . . . . . . . . . . . . . . 13-29
Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-31
Adding New Animal Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-33
Adding a New Configuration File . . . . . . . . . . . . . . . . . . 13-34
Customizing the Display . . . . . . . . . . . . . . . . . . . . . . . . 13-36
Turning on the Gains Template . . . . . . . . . . . . . . . . . . . 13-37
Preparing the Samples . . . . . . . . . . . . . . . . . . . . . . . . . . 13-38
Running the Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-38
Determining the Variance . . . . . . . . . . . . . . . . . . . . . . . 13-39
Baso Box Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-46
Vet Package Suggestions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-49
Examples of Customer-Defined Default Codes . . . . . . . 13-50
Turning The Vet Package Off . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-53
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-55

Chapter 14: Reticulocyte Package


Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-1
Principles of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-7
Retic Menu Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-9
Turning the Reticulocyte Package ON and OFF . . . . . . . 14-10
Retic Main Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-14
Retic Set Up Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-16
Retic Data Log Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-30
Data Review from the Retic Data Log . . . . . . . . . . . . . . 14-37
Retic QC Log Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-39
Retic Diagnostics Menu . . . . . . . . . . . . . . . . . . . . . . . . . 14-47
Retic Special Protocols Menu . . . . . . . . . . . . . . . . . . . . . 14-52
Routine Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-55
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-55
Retic Run Menu Flowchart . . . . . . . . . . . . . . . . . . . . . . . 14-56
Retic Run Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-57
Reticulocyte Specimens . . . . . . . . . . . . . . . . . . . . . . . . . 14-67
Quality Control Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-77
Control Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-77
Mixing and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-78
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-79
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-79
Operational Messages and Data Flagging . . . . . . . . . . . . 14-79
High Background Counts . . . . . . . . . . . . . . . . . . . . . . . . 14-82
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-83

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Master Table of Contents

Bibliography
Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Bibliography-1

Appendix A: Bar Codes


Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix A-1
Bar Coding Function . . . . . . . . . . . . . . . . . . . . . . Appendix A-1
Understanding the Label Code . . . . . . . . . . . . . . Appendix A-2
Bar Code Types and Characteristics . . . . . . . . . . Appendix A-3
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix A-5
Bar Code Label Formats . . . . . . . . . . . . . . . . . . . . Appendix A-5
Bar Code Check Digit Formats . . . . . . . . . . . . . . Appendix A-5
Bar Code Label Specifications . . . . . . . . . . . . . . . Appendix A-6
CELL-DYN Bar Code Labels . . . . . . . . . . . . . . . . . Appendix A-7
CELL-DYN Q Labels . . . . . . . . . . . . . . . . . . . . . . . Appendix A-7
Bar Code Label Placement . . . . . . . . . . . . . . . . . . Appendix A-8
Acknowledgment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix A-9

Appendix B: Parts List


Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix B-1
CELL-DYN 3700 Accessories . . . . . . . . . . . . . . . . Appendix B-1

Appendix C
Appendix C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix C-1

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List of Figures

List of Figures

Figure 1.1: CELL-DYN 3700SL System. . . . . . . . . . . . . . . . . . . . 1-1


Figure 1.2: CELL-DYN 3700 System . . . . . . . . . . . . . . . . . . . . . 1-5
Figure 1.3: CELL-DYN 3700CS System Analyzer Front View . . 1-6
Figure 1.4: Analyzer Flow Panel Components . . . . . . . . . . . . . 1-9
Figure 1.5: Analyzer Left Side Panel Components . . . . . . . . . 1-14
Figure 1.6: Analyzer Rear Panel Components . . . . . . . . . . . . . 1-17
Figure 1.7: Power Supply Module Voltage
Switch Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
Figure 1.8: Data Station — Front View. . . . . . . . . . . . . . . . . . . 1-19
Figure 1.9: Data Station — Rear Components . . . . . . . . . . . . . 1-21
Figure 1.10: Control Button – Front View . . . . . . . . . . . . . . . . 1-23
Figure 1.11: Inputs Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . 1-25
Figure 1.12: Caution Label . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-28

Figure 2.1: Data Station Rear Components . . . . . . . . . . . . . . . . 2-8


Figure 2.2: CELL-DYN 3700SL . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
Figure 2.3: Tube Rack Showing Label Placement Locations. . 2-13
Figure 2.4: Left Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16
Figure 2.5: Front Flow Panel . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18

Figure 3.1: Volumetric Metering . . . . . . . . . . . . . . . . . . . . . . . 3-11


Figure 3.2: WOC Flow Cell . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14
Figure 3.3: WBC Light Scatter . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
Figure 3.4: Optical Bench Assembly . . . . . . . . . . . . . . . . . . . . 3-17
Figure 3.5: Mononuclear-Polymorphonuclear Scatter . . . . . . 3-20
Figure 3.6: Neutrophil-Eosinophil Scatter. . . . . . . . . . . . . . . . 3-21
Figure 3.7: Mononuclear Scatter . . . . . . . . . . . . . . . . . . . . . . . 3-22
Figure 3.8: WBC Histograms . . . . . . . . . . . . . . . . . . . . . . . . . . 3-24
Figure 3.9: WBC Data and Scatterplots . . . . . . . . . . . . . . . . . . 3-25
Figure 3.10: Volumetric Metering . . . . . . . . . . . . . . . . . . . . . . 3-28
Figure 3.11: RBC Data and Histogram. . . . . . . . . . . . . . . . . . . 3-30
Figure 3.12: PLT Data and Histogram . . . . . . . . . . . . . . . . . . . 3-33
Figure 3.13: Flagging Diagnostics Screen . . . . . . . . . . . . . . . . 3-41
Figure 3.14: Scatterplot with Increased Stroma in the
N1 Region . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-43

Figure 5.1: Data Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2


Figure 5.2: Main Menu Screen. . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Figure 5.3: Set Up Menu Screen . . . . . . . . . . . . . . . . . . . . . . . 5-13
Figure 5.4: Date/Time Set Up Screen. . . . . . . . . . . . . . . . . . . . 5-14
Figure 5.5: Patient Limit Set Screen. . . . . . . . . . . . . . . . . . . . . 5-16
Figure 5.6: Diluent Log Screen . . . . . . . . . . . . . . . . . . . . . . . . 5-19

CELL-DYN® 3700 Operator’s Manual Master Table of Contents-11


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List of Figures

Figure 5.7: QC Set Up Menu Screen . . . . . . . . . . . . . . . . . . . . 5-21


Figure 5.8: QC File Set Up (Lot Number Entry) Screen . . . . . 5-22
Figure 5.9: QC File Set Up (Replicate ID Entry) Screen . . . . . 5-23
Figure 5.10: QC Range Entry Screen . . . . . . . . . . . . . . . . . . . . 5-27
Figure 5.11: QC Means/Limits Entry Screen . . . . . . . . . . . . . . 5-28
Figure 5.12: QC Means/Limits Entry Screen Showing
the Update From File Key . . . . . . . . . . . . . . . . . . . . . . . . . . 5-30
Figure 5.13: Customize QC Display Screen. . . . . . . . . . . . . . . 5-32
Figure 5.14: Customize QC Display Screen Showing
Standard Groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-35
Figure 5.15: Customize QC Printout Screen . . . . . . . . . . . . . . 5-37
Figure 5.16: X-B Set Up Screen . . . . . . . . . . . . . . . . . . . . . . . . 5-40
Figure 5.17: Operation Set Up Menu Screen. . . . . . . . . . . . . . 5-43
Figure 5.18: Bar Code Set Up Screen . . . . . . . . . . . . . . . . . . . . 5-44
Figure 5.19: Computer Set Up Screen . . . . . . . . . . . . . . . . . . . 5-46
Figure 5.20: Units Selection Screen . . . . . . . . . . . . . . . . . . . . . 5-49
Figure 5.21: Customize Displayed Report Screen . . . . . . . . . . 5-52
Figure 5.22: Customize Printed Report Screen for
Pre-Printed Tickets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-56
Figure 5.23: Customize Printed Report Screen for
Blank Tickets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-58
Figure 5.24: Customize Printed Report Screen for the
Graphics Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-61
Figure 5.25: Customize Printout Header Screen for the
Graphics Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-64
Figure 5.26: Run Screen for Patient Samples . . . . . . . . . . . . . 5-68
Figure 5.27: Run Screen for Auxiliary Samples . . . . . . . . . . . . 5-70
Figure 5.28: Run Screen Showing Count Times and
Flagging Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-73
Figure 5.29: Run Screen Showing Flagging Messages,
RBC CLOG Message, and RBC Up Time . . . . . . . . . . . . . . . 5-73
Figure 5.30: Run Screen Showing Bulletin Line Message . . . . 5-74
Figure 5.31: Work List Screen . . . . . . . . . . . . . . . . . . . . . . . . . 5-75
Figure 5.32: Specimen Type Screen. . . . . . . . . . . . . . . . . . . . . 5-77
Figure 5.33: Run Screen for Patient Samples . . . . . . . . . . . . . 5-78
Figure 5.34: Run Screen for a QC File . . . . . . . . . . . . . . . . . . . 5-79
Figure 5.35: Run Screen for Background Counts . . . . . . . . . . 5-80
Figure 5.36: Run Screen for Electrical Background Counts . . 5-81
Figure 5.37: Run Screen for Resistant RBC Specimen Type . . 5-82
Figure 5.38: Auxiliary Specimen Type Screen . . . . . . . . . . . . . 5-83
Figure 5.39: Run Screen for the Auxiliary Specimen Type . . . 5-85
Figure 5.40: Work List Screen . . . . . . . . . . . . . . . . . . . . . . . . 5-104
Figure 5.41: Work List Set Up Screen . . . . . . . . . . . . . . . . . . 5-108
Figure 5.42: Data Log Screen . . . . . . . . . . . . . . . . . . . . . . . . . 5-121
Figure 5.43: Display Specimen Screen . . . . . . . . . . . . . . . . . 5-124
Figure 5.44: Data Log Search Screen . . . . . . . . . . . . . . . . . . . 5-126
Figure 5.45: Data Log Screen Showing Reject From X-B Key 5-127

Master Table of Contents-12 CELL-DYN® 3700 Operator’s Manual


9140320F — April 2007
List of Figures

Figure 5.46: Data Log Screen Showing Accept Into X-B Key 5-128
Figure 5.47: Customize Display for Data Log Screen . . . . . . 5-129
Figure 5.48: Customize Display Showing Standard Groups . 5-130
Figure 5.49: Customize Printout for Data Log Screen . . . . . 5-132
Figure 5.50: Print Data Log Screen . . . . . . . . . . . . . . . . . . . . 5-134
Figure 5.51: Customize Display for Data Log Screen
Showing Standard Groups . . . . . . . . . . . . . . . . . . . . . . . . 5-135
Figure 5.52: Customize Printout for Data Log Screen
Showing Customized Print Group . . . . . . . . . . . . . . . . . . 5-138
Figure 5.53: Display Specimen Screen . . . . . . . . . . . . . . . . . 5-140
Figure 5.54: Edit Specimen Screen . . . . . . . . . . . . . . . . . . . . 5-142

Figure 6.1: Calibration Screen Displaying Open Mode


Calibration Factors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-14
Figure 6.2: Calibration Menu Screen Displaying Closed
Mode Calibration Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15
Figure 6.3: Enter Calibration Factor Screen . . . . . . . . . . . . . . 6-16
Figure 6.4: Calibration Log Screen . . . . . . . . . . . . . . . . . . . . . 6-18
Figure 6.5: Auto-Calibration Screen for
CELL-DYN 3700CS System . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19
Figure 6.6: Whole Blood Auto-Cal Screen. . . . . . . . . . . . . . . . 6-20
Figure 6.7: Whole Blood Auto-Cal Screen. . . . . . . . . . . . . . . . 6-22
Figure 6.8: Whole Blood Auto-Cal Results Screen . . . . . . . . . 6-23
Figure 6.9: Whole Blood Auto-Cal Results Screen
with Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-24
Figure 6.10: Calibrator Auto-Cal Screen . . . . . . . . . . . . . . . . . 6-25
Figure 6.11: Latex Auto-Cal Screen . . . . . . . . . . . . . . . . . . . . . 6-26

Figure 7.1: QC Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3


Figure 7.2: The X-B RBC Data Screen . . . . . . . . . . . . . . . . . . . . 7-4
Figure 7.3: The X-B RBC Graphs Screen . . . . . . . . . . . . . . . . . . 7-5
Figure 7.4: The X-B WBC Data Screen. . . . . . . . . . . . . . . . . . . . 7-6
Figure 7.5: The X-B WBC Graphs Screen. . . . . . . . . . . . . . . . . . 7-7
Figure 7.6: The View QC Log Screen . . . . . . . . . . . . . . . . . . . . . 7-8
Figure 7.7: The Levey-Jennings Menu Screen . . . . . . . . . . . . . 7-11
Figure 7.8: QC Log Screen With Rejected Results. . . . . . . . . . 7-12
Figure 7.9: Levey-Jennings Menu Screen Showing
Westgard Rule Violations . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-18

Figure 8.1: Laser Hazard Label. . . . . . . . . . . . . . . . . . . . . . . . . . 8-8


Figure 8.2: Laser Aperture and Warning Label Position -
Protective Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8
Figure 8.3: Laser Warning Label Position - Flow Panel. . . . . . . 8-9
Figure 8.4: Class 2 Laser Caution Label. . . . . . . . . . . . . . . . . . . 8-9
Figure 8.5: Class 2 Laser Caution Label Location . . . . . . . . . . . 8-9
Figure 8.6: Laser Label, Rear Panel . . . . . . . . . . . . . . . . . . . . . 8-10
Figure 8.7: Class 1 Laser Product Label Location . . . . . . . . . . 8-10

CELL-DYN® 3700 Operator’s Manual Master Table of Contents-13


9140320F — April 2007
List of Figures

Figure 9.1: Analyzer Flow Panel Components . . . . . . . . . . . . . 9-3


Figure 9.2: Special Protocols Screen . . . . . . . . . . . . . . . . . . . . . 9-5
Figure 9.3: Reagent Reservoir Screen . . . . . . . . . . . . . . . . . . . . 9-7
Figure 9.4: Special Protocols Screen 2. . . . . . . . . . . . . . . . . . . . 9-9
Figure 9.5: Maintenance Log Screen . . . . . . . . . . . . . . . . . . . . 9-13
Figure 9.6: Interval Set Up Screen . . . . . . . . . . . . . . . . . . . . . . 9-15
Figure 9.7: Update Maintenance Log Screen. . . . . . . . . . . . . . 9-16
Figure 9.8: Special Protocols: Auto-Clean Screen . . . . . . . . . . 9-19
Figure 9.9: Shear Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-23
Figure 9.10: Sample Aspiration Peristaltic Pump . . . . . . . . . . 9-26
Figure 9.11: WOC Syringes and Syringe Assembly . . . . . . . . . 9-29
Figure 9.12: Analyzer Left Side Panel . . . . . . . . . . . . . . . . . . . 9-32
Figure 9.13: WOC Transfer Peristaltic Pump . . . . . . . . . . . . . 9-33
Figure 9.14: Special Protocols: Extended Auto-Clean Screen . 9-35
Figure 9.15: von Behrens Transducer Assembly . . . . . . . . . . . 9-40
Figure 9.16: Transducer Assembly and Aperture Plate . . . . . . 9-41
Figure 9.17: The von Behrens WIC Transducer, HGB Flow
Cell, and Solenoid 13 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-43
Figure 9.18: Open Sample Aspiration Probe . . . . . . . . . . . . . . 9-45
Figure 9.19: Flow Panel Open/Closed Mode Tubing . . . . . . . 9-48
Figure 9.20: Closed Sampler Module . . . . . . . . . . . . . . . . . . . 9-51
Figure 9.21: Analyzer Flow Panel: Accessing Normally
Closed Valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-52

Figure 10.1: First Diagnostics Menu Screen . . . . . . . . . . . . . . 10-5


Figure 10.2: Operator Correctable Fault Report Screen . . . . . 10-6
Figure 10.3: Fatal Fault Report Screen. . . . . . . . . . . . . . . . . . . 10-7
Figure 10.4: Fault Report — No Fault Pending Screen. . . . . . . 10-7
Figure 10.5: Count Rate Summary Screen. . . . . . . . . . . . . . . . 10-8
Figure 10.6: WOC Count Rate Data (Tabular Format) . . . . . . 10-9
Figure 10.7: WOC Count Rate Graph . . . . . . . . . . . . . . . . . . 10-10
Figure 10.8: Raw Data Summary Screen . . . . . . . . . . . . . . . . 10-11
Figure 10.9: Second Diagnostics Menu Screen . . . . . . . . . . . 10-12
Figure 10.10: Pump Operation Screen . . . . . . . . . . . . . . . . . 10-13
Figure 10.11: Pump Operation Screen — Vacuum ON . . . . . 10-14
Figure 10.12: Inhibit Pumps Screen . . . . . . . . . . . . . . . . . . . 10-15
Figure 10.13: Vacuum Test Screen . . . . . . . . . . . . . . . . . . . . 10-16
Figure 10.14: Drain Accumulators Screen . . . . . . . . . . . . . . . 10-17
Figure 10.15: Third Diagnostics Menu Screen . . . . . . . . . . . 10-18
Figure 10.16: Voltage Readings Screen . . . . . . . . . . . . . . . . . 10-19
Figure 10.17: Fourth Diagnostics Menu Screen . . . . . . . . . . 10-20
Figure 10.18: Fifth Diagnostics Menu Screen
(CELL-DYN 3700SL System) . . . . . . . . . . . . . . . . . . . . . . . 10-21
Figure 10.19: Auto-Sampler Version Screen . . . . . . . . . . . . . 10-22
Figure 10.20: Serial Test Screen. . . . . . . . . . . . . . . . . . . . . . . 10-23
Figure 10.21: Serial Test Transmit Message Screen
Transmit Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-25

Master Table of Contents-14 CELL-DYN® 3700 Operator’s Manual


9140320F — April 2007
List of Figures

Figure 10.22: Sample Loader Vent/Aspiration Needle


Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-33
Figure 10.23: Sample Loader Vent/Aspiration Needle —
Tubing Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-34
Figure 10.24: Volumetric Metering . . . . . . . . . . . . . . . . . . . . 10-50

Figure 12.1: Analyzer with Sample Loader . . . . . . . . . . . . . . . 12-1


Figure 12.2: Rack Movement - Top View . . . . . . . . . . . . . . . . 12-2
Figure 12.3: Tube Labeling Requirements. . . . . . . . . . . . . . . . 12-3
Figure 12.4: Sample Loader . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5
Figure 12.5: Operation Keyboard . . . . . . . . . . . . . . . . . . . . . . 12-6
Figure 12.6: Tower Stations . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-7
Figure 12.7: Tube Racks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-10

Figure 13.1: Operation Set Up Menu Screen. . . . . . . . . . . . . . 13-9


Figure 13.2: Set Up Menu Screen . . . . . . . . . . . . . . . . . . . . . 13-11
Figure 13.3: Animal Type Set Up Screen . . . . . . . . . . . . . . . . 13-12
Figure 13.4: View Animal Type Set Up Screen . . . . . . . . . . . 13-13
Figure 13.5: Animal Limit Set 1. . . . . . . . . . . . . . . . . . . . . . . 13-14
Figure 13.6: Animal Type Catalog Screen . . . . . . . . . . . . . . . 13-16
Figure 13.7: Catalog Contents, Animal Type Set Up Screen . 13-17
Figure 13.8: Expected Ranges . . . . . . . . . . . . . . . . . . . . . . . . 13-18
Figure 13.9: Run Screen for Animals . . . . . . . . . . . . . . . . . . . 13-21
Figure 13.10: Animal Type Selection Screen . . . . . . . . . . . . . 13-22
Figure 13.11: Specimen Type Screen. . . . . . . . . . . . . . . . . . . 13-23
Figure 13.12: Dog Background Count. . . . . . . . . . . . . . . . . . 13-24
Figure 13.13: Enter Calibration Factor Screen . . . . . . . . . . . 13-28
Figure 13.14: Add New Animal Type Screen . . . . . . . . . . . . . 13-34
Figure 13.15: Customized Display for Adding New Animals 13-36
Figure 13.16: Gains Template . . . . . . . . . . . . . . . . . . . . . . . . 13-37
Figure 13.17: Target Locations for the Neutrophil and
Lymphocyte populations . . . . . . . . . . . . . . . . . . . . . . . . . 13-39
Figure 13.18: Set Point Entry Screen . . . . . . . . . . . . . . . . . . . 13-44
Figure 13.19: Baso Box Set Up. . . . . . . . . . . . . . . . . . . . . . . . 13-46

Figure 14.1: Operation Set Up Menu Screen with


Reticulocyte Package Disabled . . . . . . . . . . . . . . . . . . . . . . 14-10
Figure 14.2: Operation Set Up Menu Screen with
Reticulocyte Package Enabled. . . . . . . . . . . . . . . . . . . . . . 14-12
Figure 14.3: Reticulocyte Main Menu Screen . . . . . . . . . . . . 14-14
Figure 14.4: Reticulocyte Set Up Screen . . . . . . . . . . . . . . . . 14-16
Figure 14.5: Reticulocyte Patient Limits Screen . . . . . . . . . . 14-18
Figure 14.6: Reticulocyte QC Set Up Screen . . . . . . . . . . . . . 14-19
Figure 14.7: Retic QC Range Entry Screen . . . . . . . . . . . . . . 14-21
Figure 14.8: Retic QC Means/Limits Screen . . . . . . . . . . . . . 14-22
Figure 14.9: Retic Set Up QC Screen . . . . . . . . . . . . . . . . . . . 14-25

CELL-DYN® 3700 Operator’s Manual Master Table of Contents-15


9140320F — April 2007
List of Figures

Figure 14.10: Operation Set Up Menu Screen with


Reticulocyte Package Enabled. . . . . . . . . . . . . . . . . . . . . . 14-27
Figure 14.11: Reticulocyte Units Selection Screen . . . . . . . . 14-28
Figure 14.12: Reticulocyte Data Log Screen . . . . . . . . . . . . . 14-31
Figure 14.13: Reticulocyte Display Specimen Screen . . . . . . 14-33
Figure 14.14: Reticulocyte Data Log Search Screen . . . . . . . 14-35
Figure 14.15: Reticulocyte Data Log Screen Showing the
Starting Reticulocyte Sequence Number Field . . . . . . . . . 14-36
Figure 14.16: Reticulocyte Display Specimen Screen . . . . . . 14-37
Figure 14.17: Reticulocyte QC Log Screen . . . . . . . . . . . . . . 14-39
Figure 14.18: View Reticulocyte QC Log Screen . . . . . . . . . . 14-41
Figure 14.19: The Reticulocyte Levey-Jennings Screen. . . . . 14-44
Figure 14.20: View Reticulocyte QC Log Screen with
Rejected Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-45
Figure 14.21: Reticulocyte Diagnostics Screen . . . . . . . . . . . 14-48
Figure 14.22: Reticulocyte Count Rate Summary Screen
(Tabular Format) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-49
Figure 14.23: Reticulocyte Count Rate Summary Screen
(Graphic Format) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-50
Figure 14.24: Reticulocyte Raw Data Summary Screen . . . . 14-51
Figure 14.25: Reticulocyte Special Protocols Screen. . . . . . . 14-53
Figure 14.26: Reticulocyte Run Screen . . . . . . . . . . . . . . . . . 14-57
Figure 14.27: The First Reticulocyte Patient Specimen
Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-58
Figure 14.28: The Second Reticulocyte Patient Specimen
Screen (Displayed When the Specimen ID is Found) . . . 14-59
Figure 14.29: The Third Reticulocyte Patient Specimen
Screen (Displayed When the Specimen ID Found is
More Than Eight Hours Old) . . . . . . . . . . . . . . . . . . . . . . 14-60
Figure 14.30: The Fourth Reticulocyte Patient Specimen
Screen (Displayed When the Specimen ID Is Not Found) 14-61
Figure 14.31: The Reticulocyte Run Result Screen for a
Patient Specimen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-62
Figure 14.32: Reticulocyte Run Result Screen for a
QC Specimen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-65
Figure 14.33: Reticulocyte Run Result Screen for a
Background Specimen . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-66

Figure A.1: Bar Code Label Specifications . . . . . . . . . Appendix A-6


Figure A.2: Tube Labeling Requirements . . . . . . . . . Appendix A-8

Master Table of Contents-16 CELL-DYN® 3700 Operator’s Manual


9140320F — April 2007
List of Tables

List of Tables

Table 3.1: Parameter Flagging Messages . . . . . . . . . . . . . . . . . 3-39


Table 4.1: Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Table 4.2: Power Specifications . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Table 4.3: Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Table 4.4: Power Specifications . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Table 4.5: Precision of the Hemogram and Reticulocyte
Parameters (N = 31) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16
Table 4.6: Precision of the WBC Differential Parameters . . . . 4-16
Table 4.7: Linearity Specifications . . . . . . . . . . . . . . . . . . . . . 4-17
Table 4.8: Accuracy of Hemogram Parameters . . . . . . . . . . . . 4-18
Table 4.9: Accuracy of WBC Differential Parameters . . . . . . . 4-19
Table 4.10: Carryover for WBC, RBC, HGB, PLT and Retics . . 4-19
Table 4.11: Typical Precision for Hemogram Parameters. . . . 4-20
Table 4.12: Reference Range for Distributional Flagging . . . . 4-21
Table 4.13: Reference Range for Morphologic Flagging . . . . . 4-21
Table 4.14: Abnormalities Evaluated. . . . . . . . . . . . . . . . . . . . 4-22
Table 4.15: Flagging Analysis Truth Table . . . . . . . . . . . . . . . 4-23
Table 4.16: Analysis of False Negative Results . . . . . . . . . . . . 4-23
Table 5.1: Report Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-50
Table 6.1: Calibration Criteria. . . . . . . . . . . . . . . . . . . . . . . . . 6-41
Table 6.2: Calibration Criteria. . . . . . . . . . . . . . . . . . . . . . . . . 6-51
Table 6.3: Calibration Criteria. . . . . . . . . . . . . . . . . . . . . . . . . 6-63
Table 6.4: Mode to Mode Calibration Criteria . . . . . . . . . . . . 6-78
Table 6.5: Mode to Mode Calibration Criteria . . . . . . . . . . . . 6-87
Table 7.1: Troubleshooting X-B RBC. . . . . . . . . . . . . . . . . . . . 7-23
Table 7.2: Default (Preset) X-B WBC Values . . . . . . . . . . . . . . 7-25
Table 13.1: Precision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-5
Table 13.2: Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-6
Table 13.3: Linearity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-7
Table 13.4: Carryover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-7
Table 14.1: Potential Interfering Substances. . . . . . . . . . . . . 14-69
Table B.1: CELL-DYN 3700 Accessories Kit
(List Number 06H88-01) . . . . . . . . . . . . . . . . . . . . . Appendix B-1
Table B.2: CELL-DYN 3700 Sample Loader
Accessories Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix B-2
Table B.3: CELL-DYN 3700 Optional Accessories . . . Appendix B-3
Table B.4: CELL-DYN 3700 Calibrators and
Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix B-4
Table B.5: CELL-DYN 3700 Reagents. . . . . . . . . . . . . Appendix B-4

CELL-DYN® 3700 Operator’s Manual Master Table of Contents-17


9140320F — April 2007
List of Tables

NOTES

Master Table of Contents-18 CELL-DYN® 3700 Operator’s Manual


9140320F — April 2007
Foreword
Introduction

We welcome you to the role of Operator of a CELL-DYN 3700


System. Your system, which includes state-of-the-art technology, is
designed to function consistently and dependably from day to
day.
The CELL-DYN 3700 System is backed by dedicated professionals
who excel in engineering, medical technology, training, and
service. As part of the customer training program, we will teach
you to operate, maintain and troubleshoot your System.
Abbott Laboratories is dedicated to manufacturing the highest
quality, most reliable instrumentation available. We look forward
to serving your needs in any way possible.

Customer Service
United States: 1 (877) 4ABBOTT or 1 (877) 422-2688

Abbott Diagnostics Division


Customer Service
200 Abbott Park Road
Abbott Park, IL 60064, USA

Canada: 1 (800) 387-8378

For customers outside the US, call your local Customer Service
Representative.

Intended Use
The CELL-DYN 3700 System is a multiparameter, automated
hematology analyzer designed for in vitro diagnostic use in
clinical laboratories.

Proprietary Statement
The entire contents are copyright 2000, 2003, 2004, and 2007 by
Abbott Laboratories. Abbott Laboratories’ software programs are
protected by copyright. All rights are reserved. This software was
developed solely for use with Abbott Laboratories’ equipment and
for in vitro diagnostic applications as specified in the operating
instructions. No part of this document may be reproduced, stored,
or transmitted in any form or by any means (electronic,
mechanical, photocopied, recorded, or otherwise) without the
prior written permission of Abbott Laboratories.

CELL-DYN® 3700 System Operator’s Manual i


9140320F — April 2007
Patent Statement
The CELL-DYN 3700 instrument system is covered by one or more
of the following US Patents: 4,710,021; 4,726,237; 5,378,633;
5,510,267; 5,733,784; 5,017,497; 5,958,781; and 6,740,527.

Instrument Disclaimer
All operating instructions must be followed. In no event shall
Abbott be responsible for failures, errors, or other liabilities
resulting from customers’ noncompliance with the procedures
and precautions outlined herein.

Abbott has designed the CELL-DYN 3700 System components for


optimal performance. Substitution of reagents, calibrators,
controls, and components manufactured by other companies may
adversely affect the performance of the Analyzer.

Pictorial Disclaimer
All samples (printouts, graphics, displays or screens, etc.) are for
information and illustration purposes only and shall not be used
for clinical or maintenance evaluations.

ii CELL-DYN® 3700 System Operator’s Manual


9140320F — April 2007
Abbott Instrument Warranty
For US Customers Only
Abbott Laboratories warrants CELL-DYN 3000 Series Analyzers,
sold by Abbott Sales Representatives, to be free from defects in
workmanship and materials during normal use by the original
purchaser excluding items subject to wear and tear and which
require replacement during normal use as a matter of course. This
warranty shall continue for a period of one (1) year, commencing
twenty-one (21) days from the date of shipment to the original
purchaser or until title is transferred from the original purchaser,
whichever occurs first (the “Warranty Period”).
If any defects occur during the Warranty Period, contact Abbott
Diagnostics Customer Service immediately and be prepared to
furnish pertinent details concerning the defect, the model
number, and the serial number.
Warranty support is provided twenty-four (24) hours a day, seven
(7) days a week for all CELL-DYN 3000 Series customers.
This Warranty does not cover defects or malfunctions which:
1. Are not reported to Abbott during the Warranty Period and
within one week of occurrence.
2. Result from chemical decomposition or corrosion.
3. Are caused by customer or third-party abuse, misuse, or
negligence, or by failure to comply with any requirement or
instruction contained in the applicable Abbott Operator’s
Manual.
4. Result from maintenance, repair, or modification performed
without Abbott’s authorization.
Abbott’s liability for all matters arising from the supply,
installation, use, repair, and maintenance of the Instrument,
whether arising under this Warranty or otherwise, shall be limited
solely to the repair or (at Abbott’s sole discretion) replacement of
the instrument or of components thereof. In no event shall
Abbott be liable for injuries sustained by third parties, incidental
or consequential damages, or lost profits. Replaced parts shall
become the property of Abbott.
THE FOREGOING IS THE SOLE WARRANTY MADE BY ABBOTT
REGARDING THE INSTRUMENT; AND ABBOTT SPECIFICALLY
DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED,
INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY
AND OF FITNESS FOR A PARTICULAR PURPOSE.
CELL-DYN 3700 Hematology Systems are manufactured by Abbott
Diagnostics Division, Abbott Laboratories, 200 Abbott Park Road,
Abbott Park, IL 60064, USA. Please direct all inquiries concerning
information in this manual to the foregoing address.

CELL-DYN® 3700 System Operator’s Manual iii


9140320F — April 2007
Safety Agency Approvals
In Vitro Diagnostic Directive 98/79/EC
Legal Manufacturer Abbott Laboratories
Abbott Park, Il 60064 USA
Authorized Representative ABBOTT
Max-Planck-Ring 2
65205 Wiesbaden, Germany

UL 61010A-1 Approved
CSA C22.2 No. 1010.1 Approved
IEC 1010-1 Approved

Trademark Statements
CELL-DYN, and CELL-DYN HemCal are registered trademarks of
Abbott Laboratories.
MAPSS is a trademark of Abbott Laboratories.
CONTRAVES, COULTER, EPSON, EPSON STYLUS, HEMOGARD,
Luer-Lok, MICROLINE, OKIDATA, PLEXIGLAS, TEFLON, TYGON,
VACUTAINER, and Westgard are not trademarks of Abbott
Laboratories.

Symbols
The symbols listed below are used on CELL-DYN labeling,
including the instrument, reagents, calibrators, controls, and this
manual. Please note that Warning and Caution symbols and
statements are in this manual in Chapter 8: Hazards.

General Instrument Symbols

Alternating Current Input

Protective Conductor (Ground) Terminal

Off

ON

iv CELL-DYN® 3700 System Operator’s Manual


9140320F — April 2007
Specific Instrument Symbols

AC INPUT Alternating Current MODEL Model Number


Input
ALARM Alarm MONITOR Monitor

AUTO LOADER Auto Loader PAUSE Pause

AUTO SAMPLER Auto Sampler PERISTALTIC PUMP Peristaltic Pump

BUSY Busy POWER Power

COM 1 Communications Port 1 RBC METERING RBC Metering Assembly

COM 2 RBC TRANSDUCER RBC Transducer


Communications Port 2
Assembly
DATA STATION Data Station READY Ready

E/STOP Emergency Stop REPEAT Repeat

FAULT Fault RESET Reset

FREQUENCY Frequency REV Revision

FUSES RS232 Recommended


Fuses
Specification 232
HDD Hard Disk Drive SERVICE DISK Service Disk

HGB FLOWCELL Hemoglobin Flowcell SET-UP DISK Set-up Disk

HSSL High Speed Serial Link SN Serial Number

INIT Initialize SOL Solenoid

INSTALLATION DISK Installation Disk START Start

KEYBOARD Keyboard TEST INTERFACE Test Interface

LINE FREQ SELECT Line Frequency Select TOUCH Touch

LINE VOLTAGE SELECT Line Voltage Select WASTE Waste

LPT1 First Parallel Printer Port WASTE CHAMBER 1 Waste Chamber 1

LPT2 Second Parallel Printer WASTE CHAMBER 2 Waste Chamber 2


Port
MAN Manual Mode WASTE SENSOR Waste Sensor

MAX POWER WIC METERING WBC Impedance Count


Maximum Power
Metering Assembly
MIXING CHAMBER WIC TRANSDUCER WBC Impedance
Mixing Chamber Count Transducer
Assembly

CELL-DYN® 3700 System Operator’s Manual v


9140320E — September 2004
Reagent related

CN-FREE HGB/WIC LYSE Cyanide-Free Hemoglobin/WBC Impedance Count Lyse Reagent

DETERGENT Detergent Reagent

DILUENT Diluent Reagent

ENZYMATIC CLEANER CONCENTRATE Enzymatic Cleaner Concentrate

HGB Hemoglobin

HGB LYSE Hemoglobin Lyse Reagent

HGB/WIC LYSE Hemoglobin/WBC Impedance Count Lyse

LOT Lot Number

SHEATH Sheath Reagent

8oC
Storage temperature. (Example shows “Store at 2º–8ºC”)
2 oC

Use by / Expiration Date

WBC LYSE WBC Lyse Reagent

Calibrator/Control related

ASSAY VALUE Assay Value

CONTROL Control

CONTROL ASSAY Control Assay Disk

CONTROL L N H Control, Tri-Level

CONTROL L Control, Low

CONTROL N Control, Normal

CONTROL H Control, High

CONTROL I Control, Level I

CONTROL II Control, Level II

MEAN RANGE Mean Range

MEAN VALUE Mean Value

PARAMETER Parameter

RETIC CONTROL Reticulocyte Control

vi CELL-DYN® 3700 System Operator’s Manual


9140320F — April 2007
Calibrator/Control related

SYSTEM System

WB CONTROL L Whole Blood Control, Low

WB CONTROL N Whole Blood Control, Normal

WB CONTROL H Whole Blood Control, High

WB CONTROL TRI-LEVEL Whole Blood Control, Tri-Level

WB CAL Whole Blood Calibrator

WB CONTROL Whole Blood Control

Miscellaneous

Legal Manufacturer

Manufacturer

Consult instructions for use

Date of Manufacture

EC REP Authorized Representative

IVD For In Vitro Diagnostic Use

REF List Number

Separate collection for electrical and electronic equipment waste per


Directive 2002/96/EC in the European Union

CELL-DYN® 3700 System Operator’s Manual vii


9140320F — April 2007
Instrument Labeling
The following labels are affixed to the CELL-DYN 3700 System:
Current CELL-DYN customer’s instruments are CE Marked to the
European Electro-Magnetic Compliance (EMC) and Low-Voltage
Directives and have the following labels:

DANGER
GEFAHR DANGER
PELIGRO PERICOLO

LASER LIGHT WHEN OPEN.


BEI OFFENER ABDECKUNG TRITT
LASERSTRAHL AUS.
RAYON LASER SI OUVERT.
RADIACION LASER SI SE ABRE.
LUCE LASER SE APERTO.

AVOID DIRECT EXPOSURE TO BEAM.


NICHT DIREKT IN DEN LASERSTRAHL BLICKEN.
EVITER TOUTE EXPOSITION DIRECTE
AU FAISCEAU LASER.
NO SE EXPONGA DIRECTAMENTE AL RAYO LASER.
EVITARE OGNI ESPOSIZIONE DIRETTA AL RAGGIO.
PN 9230701D

Laser Label, Front Panel

Class l Laser Product


per
lEC 825-1[1993]
PN 9230702A

Laser Label, Rear Panel

ABBOTT DIAGNOSTICS
A wholly owned subsidiary of Abbott Laboratories
Abbott Park IL. 60064
THIS PRODUCT CONFORMS TO
THE APPLICABLE REQUIREMENTS
OF 21 CFR SUBCHAPTER J
AT THE DATE OF MANUFACTURE
MANUFACTURED DATE

MODEL NO.

SERIAL NO.

LIST NO. REV

MADE IN U.S.A. PN 9230308 REV E

Serial Number Label, Rear Panel

viii CELL-DYN® 3700 System Operator’s Manual


9140320E — September 2004
WARNING: SET FOR 120 VOLTS
When operation at other line voltage is required, refer to operation manual for detailed instructions.
WARNUNG: FUER 120 VOLT EINGESTELLT
Ist der Betrieb mit einer anderen Netzspannung erforderlich, entnehmen Sie die genauen
Anweisungen der Bedienungsanleitung.
MISE EN GARDE : PARAMETRE POUR UTILISATION SUR 120 VOLTS
Si une utilisation à une tension de réseau différente est requise, reportez-vous au Manuel
Technique pour de plus amples informations.
ADVERTENCIA: CONFIGURADO PARA 120 VOLTIOS
Si se necesita otra tensión diferente a la indicada, consulte el Manual de Operaciones para
instrucciones más detalladas.
AVVERTENZA: CONFIGURATO PER 120 VOLT
Se la tensione è di voltaggio diverso, fare riferimento alle istruzioni dettagliate nel Manuale di
Impiego. PN 9230003

Voltage Label, Rear Panel

CE Label

CAUTION: DO NOT HANDLE


SOLUTION CONTAINER
UNLESS PROPERLY
PROTECTED. REFER TO
OPERATOR’S MANUAL FOR
INSTALLATION PROCEDURE.

PN 9230334

Solution Container Label, Rear Panel

CELL-DYN® 3700 System Operator’s Manual ix


9140320E — September 2004
New CELL-DYN customer’s instruments are CE Marked to the
European In Vitro Diagnostic Directive, which encompasses the
requirements of the EMC and Safety Directives, and have the
following labels:

CAUTION –
CLASS 3B LASER LIGHT WHEN OPEN.
AVOID EXPOSURE TO BEAM.
PN 9230701

Laser Label, Front Panel

CLASS 1 LASER PRODUCT


PN 9230702

Laser Label, Rear Panel

ABBOTT DIAGNOSTICS DIVISION


Abbott Laboratories
Abbott Park IL, 60064 USA
THIS PRODUCT CONFORMS TO
THE APPLICABLE REQUIREMENTS
OF 21 CFR SUBCHAPTER J AT THE DATE
OF MANUFACTURE

DATE OF MANUFACTURE

MADE IN U.S.A. PN 9230308 REV G

Serial Number Label, Rear Panel

Biological Risk
PN 9231446

Biological Risk Label, Touch Plate

x CELL-DYN® 3700 System Operator’s Manual


9140320F — April 2007
ABBOTT LABORATORIES
Abbott Park, IL 60064 USA

ABBOTT
Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580 PN 9230751A

CE Mark Label, Rear Panel

WARNING: SET FOR 120 VOLTS / ACHTUNG: FR 120 VOLT EINGESTELLT /
MISE EN GARDE : UTILISATION A 120 VOLTS / ADVERTENCIA: 120 VOLTIOS /
AVVERTENZA: CONFIGURATO A 120 VOLT / AVISO: CONFIGURADO PARA 120 VOLTS /
ADVARSEL: KONFIGURERET TIL 120 V / VARNING: INSTLLD FR 120 VOLT /
ΠΡΟΕΙΔΟΠΟΙΗΣΗ: ΧΡΗΣΗ ΣΤΑ 120 VOLTS

Consult instructions for use if different voltage is required. / Ist der Betrieb mit einer anderen
Netzspannung erforderlich, in der Bedienungsanleitung nachlesen. / Si une utilisation  une
tension diffrente est requise, consulter les instructions d’utilisation. / Consulte las instrucciones de
uso si la tensin es distinta. / Per un voltaggio diverso, consultare le istruzioni per l’uso. /
Se for necessria uma voltagem diferente, consultar as instru
es de utiliza o. /
Se brugermanualen, hvis der er behov for drift med en anden netsp nding. / L s tillhrande
dokumentation om en annan sp nning behvs. / Για χρήση σε άλλη τάση ρεύματος,
συμβουλευτείτε τις οδηγίες χρήσης.
PN 9230003F

Voltage Label, Rear Panel

CAUTION: Do not handle Solution Container unless properly protected.


VORSICHT: Die Reagenzbeh lter nur ordnungsgem  gesichert bewegen.
ATTENTION : Ne pas manipuler le flacon de solution sans protection
approprie.
PRECAUCIN: no maneje el recipiente de la solucin a menos que est protegido adecuadamente.
ATTENZIONE: Non maneggiare il recipiente della soluzione se non si  protetti in modo adeguato.
ATENO: n o manipular o recipiente da solu o sem estar devidamente protegido.
VIGTIGT: Beholderen med oplsning m ikke hndteres, medmindre brugeren er korrekt beskyttet.
VIKTIGT: Anv nd skyddskl der vid hantering av lsningsbehllarna.
ΠΡΟΣΟΧΗ: Χρησιμοποιείτε το Δοχείο Ρυθμιστικού διαλύματος μόνο αφού λάβετε τις
κατάλληλες προφυλάξεις.
UPOZORNĚNÍ: Nemanipulujte s nádobou obsahující roztok, pokud není řádně zabezpečena.
Consult instructions for use. / Gebrauchsanweisung beachten. / Consulter les instructions
d’utilisation. / Consulte las instrucciones de uso. / Consultare le istruzioni per l’uso. /
Consultar as instru
es de utiliza o. / Se brugsanvisningen. / L s tillhrande
dokumentation. / Συμβουλευτείτε τις οδηγίες χρήσης. / Viz návod k použití.
PN 9230334F

Solution Container Label, Rear Panel

CELL-DYN® 3700 System Operator’s Manual xi


9140320E — September 2004
ABBOTT LABORATORIES
Abbott Park, IL 60064 USA

ABBOTT
Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580 PN 9230963
9230751A
PN

Small CE Mark Label, Rear of Data Station

CAUTION - CLASS 2 LASER LIGHT WHEN


OPEN AND INTERLOCK IS DEFEATED
DO NOT STARE INTO THE BEAM
PN 9230323

Class 2 Laser Label, Sample Loader Cover

ABBOTT DIAGNOSTICS DIVISION


Abbott Laboratories
Abbott Park IL, 60064 USA

MADE IN U.S.A. PN 9230010 REV K

Serial Number Label, Rear of Data Station

xii CELL-DYN® 3700 System Operator’s Manual


9140320E — September 2004
Conventions Used in This Manual

The following conventions are used in this manual:


Information Presentation Examples
Note, Caution, Warning ALL CAPS, BOLDFACE NOTE:
Bulletin message, status, or other MONOSPACE FONT, Ready
screen display BOLDFACE
Data entry field <Sans Serif Font, Angle Brackets> <Date/Time>
Menu names SANS SERIF FONT, ALL CAPS, SET UP
Soft key names [SANS SERIF FONT, ALL CAPS, [SET UP]
BRACKETS]
References to other text Bold: Bold & Italics Chapter: Title,
Subsection: Heading
Soft keys are also depicted as follows in margins and flowcharts:

MAIN MENU
KEYS

SUBMENU
KEYS

TOGGLE
KEYS

TOGGLE
KEYS

CELL-DYN® 3700 System Operator’s Manual xiii


9140320E — September 2004
Flowchart Conventions
Menus are shown as square-cornered rectangles in the flowcharts,
and soft keys are shown as round-cornered rectangles:

MAIN MENU
Ready

SET UP RUN DATA LOG RETIC QUALITY


DATA LOG CONTROL

The Page Down key is depicted as follows:


Page
Down

When procedures are depicted in flowcharts, shaded boxes and


bold lines indicate which soft keys to press:

MAIN MENU
Ready

SET UP RUN DATA LOG RETIC QUALITY


DATA LOG CONTROL

PATIENT REAGENT QC SET OPERATION


LIMITS LOG UP MENU SET UP

TURN ON TURN ON BAR CODE


VET PKG RETIC PKG SET UP

xiv CELL-DYN® 3700 System Operator’s Manual


9140320E — September 2004
Safety
The CELL-DYN 3700 System has been designed to minimize
hazards to the operator. Operation, maintenance, and servicing of
hematology systems may expose individuals to potential safety
and health hazards. All work must be performed in accordance
with procedures described in the CELL-DYN Operator’s Manual or
as directed by an Abbott Representative. For detailed Safety
information refer to Chapter 8: Hazards.
Warnings are inserted in this manual to alert personnel to
potential hazards. The standard warning conventions including
signal words (e.g., Caution) and symbols are described in Chapter
8: Hazards.

CELL-DYN® 3700 System Operator’s Manual xv


9140320E — September 2004
Revision Status

Document Control Revision Section(s) Pages Revised


Number(s) Date Revised and Added
Original Issue 12/98 Not Applicable Not Applicable
(9140320A)
9140320B 3/99 Chapter 10 10-75, 10-76,
Chapter 14 14-1, 14-2, 14-25,14-26,
14-29, 14-30, 14-39, 14-40,
14-43, 14-44, 14-59, 14-60,
14-61, 14-62, 14-67, 14-68,
14-71, 14-72, 14-75, 14-76,
14-77, 14-78, 14-85, 14-86,
Revision Status viii.
9140320C 11/00 All All
9140320D 6/03 Master Table of All
Contents
Foreword All
1: System 1-6 through 1-9; 1-11; 1-17
Description through 1-24; 1-27
2: Installation 2-1; 2-3 through 2-5; 2-14
3: Principles of 3-36
Operation
4: System 4-5 through 4-7; 4-11; 4-23
Specifications
5: Operating 5-7; 5-9 and 5-10; 5-12; 5-50;
Instructions 5-67; 5-88 through 5-91; 5-93
through 5-95; 5-98 through
5-102; 5-119; 5-121; 5-143
6: Calibration 6-3; 6-26; 6-40
7: Quality Control 7-17; 7-25
8: Hazards All
9: Maintenance 9-3 and 9-4; 9-23 and 9-24;
9-27 through 9-54
10: Troubleshooting 10-32; 10-35 and 10-36;
10-58; 10-60; 10-68; 10-85
12: Sample Loader 12-6 and 12-7; 12-11
13: Veterinary 13-44 and 13-45; 13-47;
Package 13-52
14: Reticulocyte 14-1; 14-3; 14-69; 14-71
through 14-75, 14-77 and
14-78; 14-81
Appendix A All
Appendix B New
Index New

xvi CELL-DYN® 3700 System Operator’s Manual


9140320E — September 2004
Document Control Revision Section(s) Pages Revised
Number(s) Date Revised and Added
9140320E 9/2004 Master Table of All
Contents
Foreword All
1: System 1-1; 1-6; 1-9; 1-24 through
Description 1-27
2: Installation 2-1; 2-3; 2-5; 2-9; 2-12 and
2-13; 2-15
3: Principles of 3-36 through 3-49; 3-55 and
Operation 3-56
4: System 4-6; 4-11; 4-17; 4-19
Specifications
5: Operating 5-17 through 5-19; 5-50; 5-87
Instructions through 5-89; 5 103; 5-110;
5-123
6: Calibration 6-1; 6-3; 6-30; 6-35; 6-38;
6-53; 6-57; 6-64; 6-68 and
6-69; 6-79; 6-82 and 6-83;
6-89 and 6-90; 6-92 through
6-96
7: Quality Control 7-15 through 7-19; 7-23;
7-26
9: Maintenance 9-2 and 9-3; 9-19 and 9-20;
9-23; 9-26 and 9-27; 9-29 and
9-30; 9-32 through 9-34;
9-36 and 9-37; 9-40; 9-43;
9-45 and 9-46; 9-48; 9-52;
9-54
10: Troubleshooting 10-23; 10-25; 10-28; 10-32;
10-34 through 10-37; 10-42;
10-57 and 10-58; 10-60
through 10-65; 10-76; 10-78
through 10-87
11: Printers 11-4; 11-6; 11-13
12: Sample Loader 12-1 and 12-3
13: Veterinary 13-8
Package
14: Reticulocyte 14-14; 14-32 through 14-34;
14-69; 14-71; 14-82
Appendix A 7 and 8
Appendix B 1 and 2; 4
Appendix C New

CELL-DYN® 3700 System Operator’s Manual xvii


9140320E — September 2004
Document Control Revision Section(s) Pages Revised
Number(s) Date Revised and Added
9140320F 4/2007 Master Table of All
Contents
List of Figures All
List of Tables All
Foreword i through iv; vi and vii, x,
xviii through xx
1: System 1-5; 1-19 through 1-21; 1-23
Description through 1-32
2: Installation 2-7 through 2-20
3: Principles of 3-1 through 3-20; 3-36; 3-39;
Operation 3-43 through 3-64
4: System 4-15; 4-17; 4-20; 4-23; 4-25
Specifications
5: Operating 5-88; 5-90 through 5-91;
Instructions 5-143
6: Calibration 6-5 and 6-6; 6-29; 6-35; 6-99
7: Quality Control 7-9; 7-16 through 7-17
9: Maintenance 9-54
10: Troubleshooting 10-61
11: Printers All
13: Veterinary 13-8
Package
14: Reticulocyte 14-7 and 14-8; 14-68; 14-69;
14-71; 14-77 and 14-78; 14-83
Bibliography All
Appendix B B-4
Index All

xviii CELL-DYN® 3700 System Operator’s Manual


9140320F — April 2007
Revision Log

Instructions: Use this log to provide a permanent record to verify that revised chapter(s) and/or
page(s) have been added to this manual.

1. Record the document control number of the revised section in the first column. You will find the
number in the footer. Make an entry for each chapter you receive and place in the manual.
2. Record the revision date, also found in the footer, in the second column.
3. Record the current CELL-DYN 3700 System software version in the third column.
4. Write your initials or signature in the fourth column to verify that you have placed the revised
page(s) in the manual.
5. Record the date that you added the revised section to the manual in the fifth column.

Document Revision
Control Revision Software Incorporated Date
Number Date Version by Incorporated

CELL-DYN® 3700 System Operator’s Manual xix


9140320F — April 2007
NOTES

xx CELL-DYN® 3700 System Operator’s Manual


9140320F — April 2007
Chapter 1 System Description
System Description

Overview

The CELL-DYN 3700 System is a multi-parameter, automated


hematology analyzer designed for in vitro diagnostic use in
clinical laboratories. The instrument has two versions: the
CELL-DYN 3700SL System with an automated Sample Loader and
the CELL-DYN 3700CS System with a manual Closed Sampler.

Insert Color Photo

Figure 1.1: CELL-DYN 3700SL System

The CELL-DYN 3700SL System is equipped with an automated


Sample Loader module. The Sample Loader provides continuous
closed sampling for up to 100 tubes at a time. (See the preceding
figure.)

The CELL-DYN 3700CS System is equipped with a built-in manual


Closed Sample Aspiration Module referred to as the Closed
Sampler. The Closed Sampler aspirates blood from a closed
collection tube that has been inserted in the Closed Sampler
Module.

CELL-DYN® 3700 System Operator’s Manual 1-1


9140320E — September 2004
System Description
Overview Chapter 1

NOTES

1-2 CELL-DYN® 3700 System Operator’s Manual


9140320C — November 2000
Chapter 1 System Description

Intended Use

The CELL-DYN® 3700 System generates the following hematologic


measurements on EDTA-anticoagulated whole blood:

WBC — White Blood Cell or Leukocyte count


NEU — Neutrophil absolute count %N — Neutrophil percent
LYM — Lymphocyte absolute count %L — Lymphocyte percent
MONO — Monocyte absolute count %M — Monocyte percent
EOS — Eosinophil absolute count %E — Eosinophil percent
BASO — Basophil absolute count %B — Basophil percent
RBC — Red Blood Cell or Erythrocyte count
HGB — Hemoglobin concentration
HCT — Hematocrit
MCV — Mean Corpuscular Volume
MCH — Mean Corpuscular Hemoglobin
MCHC — Mean Corpuscular Hemoglobin Concentration
RDW — Red Cell Distribution Width
PLT — Platelet or Thrombocyte count
MPV — Mean Platelet Volume
PDW*— Platelet Distribution Width
PCT* — Plateletcrit
RETIC % — Reticulocyte Percent
RETIC ABS — Reticulocyte Absolute
IRF — Immature Reticulocyte Fraction
* Clinical significance has not been established for these parameters.
Therefore they are not reportable in the U.S. They are provided for
laboratory use only.

CELL-DYN® 3700 System Operator’s Manual 1-3


9140320C — November 2000
System Description
Intended Use Chapter 1

NOTES

1-4 CELL-DYN® 3700 System Operator’s Manual


9140320C — November 2000
System Description
Chapter 1 System Components

System Components

The two main modules of the CELL-DYN 3700 System are depicted
in the following two figures. (The Sample Loader Module included
with the CELL-DYN 3700SL System is illustrated and described in
Chapter 2: Installation and Chapter 12: Sample Loader.)

Data Station Analyzer

Figure 1.2: CELL-DYN 3700 System

Analyzer:
The Analyzer contains the hardware to aspirate, dilute, and
analyze each whole blood specimen.

Data Station:
The Data Station contains a Flat Panel Display Monitor, a
Keyboard, and a CPU (Central Processing Unit).

CELL-DYN® 3700 System Operator’s Manual 1-5


9140320F — April 2007
System Description
System Components Chapter 1

Analyzer
Overview
The Analyzer is the central unit of the CELL-DYN 3700 System. It
aspirates and dilutes whole blood specimens, transports and
analyzes the prepared dilutions, and rinses fluidic components in
preparation for the next specimen. Except for those components
directly related to the Closed Sample Processing Method
(automated or manual), the CELL-DYN 3700CS System and
CELL-DYN 3700SL System are identical. In the description of
components on the following pages, those components applicable
to only one of the systems will be identified as such. A complete
description of the automated Sample Loader can be found in
Chapter 12: Sample Loader.

Front Panel
The components visible on the front of the Analyzer are depicted
in the following figure. The functional description of each
component follows.

Right Front Cover Status Indicator


Left Front Cover
Viewing Window Panel

Open
Sample
Aspiration
Probe

Tube
Retainer
Closed Sample Touch Plate
Aspiration Module

Figure 1.3: CELL-DYN 3700CS System Analyzer Front View

1-6 CELL-DYN® 3700 System Operator’s Manual


9140320E — September 2004
System Description
Chapter 1 System Components

Left Front Cover


The removable Left Front Cover protects the Left Flow Panel. To
remove the cover, lift up on the cover to free it from the
mounting brackets. A grounding wire provides electrical
continuity for shielding purposes. Disconnect the grounding
wire. Access to the Left Flow Panel is necessary to view the action
of the Flow Panel components and to perform certain
maintenance procedures.

Right Front Cover


The removable Right Front Cover protects the Right Flow Panel. It
contains a window that allows the operator to view the Shear
Valve. The cover is removed by lifting it up, disconnecting the
ground wires, and lifting away from the mounting brackets.
Access to the Right Flow Panel is necessary to view the operation
of the components and to perform certain maintenance
procedures.

Status Indicator Panel


Three status indicator messages (illuminated by green, yellow, and
red LEDs) indicate the status of the Analyzer. The status messages are:

• Ready (green light) — The Analyzer is ready to process a


specimen.
• Busy (yellow light) — The Analyzer is busy with a normal
operational sequence.
• Fault (red light) — The Analyzer is unable to process
specimens due to an existing fault
condition.

Open Sample Aspiration Probe


The Open Sample Aspiration Probe aspirates whole blood from an
opened collection tube. The Wash Block moves down to the end
of the probe and remains there whenever the Closed Mode is
selected.

Touch Plate
The Touch Plate is located directly behind the Open Sample
Aspiration Probe. Pressing the Touch Plate starts the selected run
cycle for both the Open Mode and Closed Mode on the
CELL-DYN 3700CS System. If the Closed Sampler Mode is selected
on the CS instrument, the cycle will begin only if a tube has been
properly inserted in the holder. On the CELL-DYN 3700SL System,
the Touch Plate is used for Open Mode only.

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Closed Sample Aspiration Module


(CELL-DYN 3700CS System Only)
The Closed Sample Aspiration Module aspirates whole blood from
a closed collection tube. It is activated when the Closed Sampler
Mode is selected. The module contains the following components:
• A Holder holds the closed collection tube.
• A Tube Retainer correctly positions the tube in the holder.
• Two Quick Adjust Levers located on either side of the Tube
Retainer are used to raise or lower the Tube Retainer in order
to securely hold the collection tube in the proper position.
• An Interlock Switch located in the Tube Retainer prevents
activation of the Closed Sampler until a collection tube is
inserted properly.
• A Needle pierces the collection tube stopper, vents vacuum
or pressure from inside the tube, aspirates the whole blood,
and is retracted and rinsed at the end of each Closed Sampler
cycle.

Automated Sample Loader Module


(CELL-DYN 3700SL System Only)
See Chapter 12: Sample Loader for information about the Sample
Loader Module.

Flow Panel
The major components of the Flow Panel are depicted in the
following figure. The functional description of each component
follows.

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9140320D — June 2003
Grounding WOC Mixing Sample Aspiration Mounting
Mounting Wire Clip Chamber A.C.C. Interlock Switch Grounding
Peristaltic Pump Bracket Wire Clip
Bracket

Figure 1.4:
Chapter 1

Overflow
Chamber
Optical
Aerosol WOC Flow Mounting Bench
Filter Cell Cover Bracket Assembly

9140320E — September 2004


von Behrens
WIC

CELL-DYN® 3700 System Operator’s Manual


Transducer
Assembly
Normally
Closed
Shear Valve Valves
WOC Transfer Assembly
Peristaltic Pump

Analyzer Flow Panel Components


.

Wash
Block

HGB
Flow Cell

WIC Metering
Assembly

Mounting Open
Bracket Sample
Aspiration
Probe
von Behrens
RBC/PLT
Transducer
Assembly
Touch
Waste Plate
Chamber 1
Vacuum WOC Metering Syringe RBC/PLT Diluent Syringe
(contains Sheath Reagent) HGB/WIC Lyse Syringe (contains Diluent)
RBC/PLT Accumulator (contains HGB/WIC Lyse)
Diluent Drain Line RBC/PLT Waste
Overpressure Chamber 2 WOC Sheath Syringe HGB/WIC Diluent Syringe
Metering
Sensor Assembly (contains Sheath Reagent) (contains Diluent)
System Description
System Components

1-9
System Description
System Components Chapter 1

Sample Aspiration Peristaltic Pump


The Sample Aspiration Peristaltic Pump is composed of a rotor
and pump tube holder. It aspirates whole blood from either an
open or closed collection tube into the Shear Valve. The pump
action is controlled by the Touch Plate and an optical detector.

Shear Valve Assembly


The three-piece ceramic Shear Valve isolates a precise volume of
whole blood by means of a shearing action as the front and rear
sections rotate. The aspirated blood is isolated in three separate
segments — one for the WOC dilution, one for the WIC/HGB
dilution, and one for the RBC/PLT dilution.

Wash Block
The Wash Block rinses the outside of the Open Sample Aspiration
Probe with Diluent. It air dries the probe and routes the external
and internal rinses to a waste chamber.

Syringe Assembly
The Syringe Assembly contains a set of five syringes: two
WIC/HGB Syringes operated by the same stepper motor and
three others (RBC Diluent, WOC Sheath, and WOC Metering
Syringes), each operated by a separate stepper motor.

• RBC/PLT Diluent Syringe — delivers a specific volume of


Diluent to transport the blood from the Shear Valve to the
Mixing Chamber in the von Behrens RBC/PLT Transducer.
• WIC/HGB Diluent Syringe — delivers a specific volume of
Diluent to transport the blood from the Shear Valve to the
WIC/HGB Mixing Chamber in the von Behrens WIC
Transducer.
• WIC/HGB Lyse Syringe — dispenses a specific volume of
WIC/HGB Lyse into the WIC/HGB Mixing Chamber at the
same time as the diluted sample is dispensed into the
chamber.
• WOC Sheath Syringe — delivers a specific volume of Sheath
Reagent to transport the blood from the Shear Valve to the
WOC Mixing Chamber.
• WOC Metering Syringe — injects a specific volume of the
WOC dilution into the WOC Flow Cell.

Waste Chambers
Two Waste Chambers collect the waste liquid from the Analyzer
Flow Panel.

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System Description
Chapter 1 System Components

ACC Interlock Switch


An Aperture Cleaning Circuit (ACC) Interlock Switch inhibits the
operation of the Aperture Cleaning Circuit when the front covers
are removed.

RBC/PLT Metering Assembly


The RBC/PLT Metering Assembly contains a precision-bore glass
tube with a set of optical detectors, one upper and one lower,
mounted on it. It meters a fixed volume of the RBC/PLT dilution
to ensure that an accurate volume is counted during the RBC/PLT
measurement.

von Behrens RBC/PLT Transducer Assembly


The von Behrens RBC/PLT Transducer Assembly contains the
fluidics and hardware required for accurate measurement of the
diluted red blood cells and platelets. The primary components of
this assembly are:

• von Behrens RBC/PLT Transducer - The Transducer contains


two chambers. The Mixing Chamber on the left is for
mixing the RBC/PLT dilution. The Counting Chamber on
the right contains the von Behrens Plate used to prevent cells
that have traversed the aperture from recirculating into the
sensing zone.
• Electrodes - There are two non-corrosive, electrically
conductive plates, one positively charged and one negatively
charged. One electrode is located in each Transducer
Chamber. The electrodes conduct a constant current flow
through the aperture during the RBC/PLT measurement.
• RBC/PLT Aperture Plate -This plate is inserted into a slot
between the two Transducer Chambers. A jewel containing
the aperture is pressure-embedded into the plate.

WIC (WBC Impedance Count) Metering Assembly


The WIC Metering Assembly contains a precision-bore glass tube
with a set of optical detectors, one upper and one lower, mounted
on it. It meters a fixed volume of the HGB/WIC dilution to ensure
that an accurate volume is counted during the WIC measurement.

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System Description
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HGB Flow Cell Assembly


The HGB Flow Cell Assembly contains the following components:
• A fully enclosed (light-tight), flow-through glass Cuvette
• An LED light source
• A Bandwidth Filter used to obtain the ICSH recommended
wavelength of 540 nm
• A Photodetector for measuring the light transmitted

WOC (WBC Optical Count) Transfer Peristaltic Pump


The WOC Transfer Peristaltic Pump is composed of a rotor and a
pump tube holder. It transports the WOC dilution to the WOC
Flow Cell.

von Behrens WIC Transducer Assembly


The von Behrens WIC Transducer Assembly contains the fluidics
and hardware required for accurate measurement of the diluted
white blood cells. The primary components of this assembly are:

• von Behrens WIC Transducer — The Transducer contains


two chambers. The Mixing Chamber on the left is for
mixing the WIC/HGB dilution. The Counting Chamber on
the right contains the von Behrens Plate used to prevent cells
that have traversed the aperture from recirculating into the
sensing zone.
• Electrodes — There are two non-corrosive, electrically
conductive plates, one positively charged and one negatively
charged. One electrode is located in each transducer
chamber. The electrodes conduct a constant current flow
through the aperture during the WIC measurement.
• WIC Aperture Plate — This plate is inserted into a slot
between the two Transducer Chambers. A jewel containing
the aperture is pressure-embedded into the plate.

Aerosol Filter
The Aerosol Filter is used to filter aerosols out of the air that leaves
the instrument.

Overflow Chamber
The Overflow Chamber collects excess fluid from the Mixing
Chambers.

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System Description
Chapter 1 System Components

WOC Mixing Chamber


The glass WOC Mixing Chamber is for mixing the WOC dilution.

WOC Flow Cell Assembly


The WOC Flow Cell Assembly, located behind the WOC Flow Cell
cover, contains the fluidics and hardware needed to
hydrodynamically focus the diluted white blood cell sample
stream. The primary components of this assembly are:

• Sample Feed Nozzle — A specially designed tube is used to


deliver the WOC dilution into the Sheath stream.
• WOC Flow Cell — An optically clear quartz flow-through
chamber with a cone-shaped bottom and central rectangular
opening focuses the sample into a single-cell stream for
measurement.

Optical Bench Assembly


The Optical Bench Assembly contains the Helium-Neon laser,
the WOC Flow Cell, the optics, and the detectors required for
counting and differentiating the white blood cells.

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System Description
System Components Chapter 1

Left Side Panel


The components on the Left Side Panel of the Analyzer are
depicted in the following figure. The functional description of
each component follows.

Analyzer Solenoid Valves


Power Switch Air Intake
Filter

Sample
Loader
Connector
Diluent
Reservoir
Waste
Sensor Sheath
Port Reservoir

Diluent
Inlet Tube
Fitting Detergent
Reservoir
Sheath
Inlet Tube
Fitting
Air Intake
Filter
Detergent
Inlet Tube
Fitting

WIC/HGB
Lyse Inlet
Tube Fitting
Waste Normally
Outlet Tube Analyzer Serial
Number Label Closed Valves
Fitting
Figure 1.5: Analyzer Left Side Panel Components

Solenoid Valves
The Solenoid Valves are used to control pressure and vacuum. The
three valves in the top row control the hydraulic pressure to the
system. The three valves in the bottom row control the vacuum
used to fill the reagent reservoirs.

Air Intake Filters


Two removable panels contain Air Intake Filters that are inserted
from the front. The filters clean the air drawn into the Analyzer by
the air circulation fans on the Rear Panel.

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System Description
Chapter 1 System Components

Diluent Reservoir
The Diluent Reservoir maintains the Diluent supply in the Analyzer.

Sheath Reservoir
The Sheath Reservoir maintains the Sheath Reagent supply in the
Analyzer.

Detergent Reservoir
The Detergent Reservoir maintains the Detergent supply in the
Analyzer.

Normally Closed Valves


Three Normally Closed Valves prevent the reagents in the
reservoirs from draining down into the Analyzer when the
Analyzer power is turned OFF.

Analyzer Serial Number Label


The Analyzer Serial Number Label contains the manufacturer's
serial number for the Analyzer.

Analyzer Power Switch


The Analyzer Power Switch is the main power switch for the
Analyzer. It is used to turn the instrument ON and OFF.

Sample Loader Connector


The Sample Loader Connector is used to attach the Serial Interface
Cable from the Sample Loader Module to the Analyzer (used with
CELL-DYN 3700SL System only).

Waste Sensor Connector


The Waste-Full Sensor Plug connects to the Waste Sensor
Connector. When the electrical sensor is activated, the EXTERNAL
WASTE FULL message is generated and the READY status is
inhibited until the situation is corrected.
NOTE: The Analyzer interprets a disconnected plug as a
full waste container. Therefore, if the waste is routed to a
drain, a Dummy Plug must be inserted in the connector.

Diluent Inlet Tube Fitting


The red color-coded Diluent Inlet Tube Fitting connects the
Diluent Inlet Tube with its associated cap, sinker, and label.

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System Description
System Components Chapter 1

Sheath Inlet Tube Fitting


The purple color-coded Sheath Inlet Tube Fitting is used to
connect the Sheath Inlet Tube with its associated cap, sinker, and
label.

Detergent Inlet Tube Fitting


The green color-coded Detergent Inlet Tube Fitting connects the
Detergent Inlet Tube with its associated cap, sinker, and label.

WIC/HGB Lyse Inlet Tube Fitting


The blue color-coded WIC/HGB Lyse Inlet Tube Fitting is used to
connect the WIC/HGB Lyse Inlet Tube with its associated cap,
sinker, and label.

Waste Outlet Tube Fitting


The black color-coded Waste Outlet Tube Fitting is used to connect
the waste outlet tube.

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System Description
Chapter 1 System Components

Rear Panel
The components visible on the Rear Panel of the Analyzer are
depicted in the following figure. The functional description of
each component follows.

Fans
Line Frequency
and Voltage
Select Switches

Fuse

Analyzer
Power
Receptacle

RS-232
Test Interface
Port

Data
Station
Port

Figure 1.6: Analyzer Rear Panel Components

Fans
Three fans cool the internal components of the Analyzer.

Line Frequency and Line Voltage Select Switches


These switches are used to select the line frequency and voltage
for the Analyzer.

WARNING: SET FOR 120 VOLTS


When operation at other line voltage is required,
refer to Operator’s Manual for detailed instructions.

PN 9230003E

Voltage Label, Rear Panel

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9140320D — June 2003
System Description
System Components Chapter 1

100V 50HZ
120V 50HZ
220V 50HZ
240V 50HZ
100V 60HZ
120V 60HZ
220V 60HZ
240V 60HZ

Figure 1.7: Power Supply Module Voltage Switch Configuration

WARNING: These switches are set at the factory for 120


volts. When operation at other line voltage is required,
refer to Figure 1.7.

Fuse
An 8-amp (100/120V)T (Slo-Blo) or 4-amp (220/240V)T (Slo/Blo)
fuse protects the Analyzer from power surges.

Analyzer Power Receptacle


The Analyzer Power Receptacle is used to connect the Main Power
Cord to the Analyzer.

RS-232 Test Interface Port


The RS-232 Test Interface Port is used by Abbott engineering and
service personnel.
NOTE: This RS-232 Port can not be used for an LIS
connection.

Data Station Port


The Data Station Port is used to connect the Analyzer to the Data
Station.

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System Description
Chapter 1 System Components

Data Station
The CELL-DYN 3700 operations are controlled by high-speed
microprocessors that monitor system status, perform the various
analytical routines used by the instrument, perform diagnostic
checks, and store result data.
Serial data (ASCII format) may be output to a Laboratory
Information System (LIS) through an RS-232 connector. Data
transmission may be performed either automatically as samples
are processed or by command of the operator. Parallel data may be
output to an on-line printer.
The Data Station Computer consists of:
• 80486 microprocessor (IBM AT compatible)

• 8 megabytes RAM minimum

• 1.2-gigabyte hard drive minimum

• 15-inch color monitor or flat panel display

NOTE: Components for both are described in this


section.

• VGA graphics

The results are stored on the hard drive for the most recent 10,000
cycles. Complete graphical data are also stored for the most recent
10,000 cycles.

Screen
Monitor
Soft Keys
Monitor
Power Switch
Contrast Control
Brightness Control
CPU

Floppy Disk Drive

Standard Computer
Keyboard

Figure 1.8: Data Station — Front View

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System Description
System Components Chapter 1

The Data Station and monitor components are shown in the


previous figure. The Standard Computer Keyboard is also shown.
The functional description of each component follows.

Monitor Front and Side Components

Screen
A 15-inch diagonal, high-resolution Screen with 16-color
illumination displays all alphanumeric and graphic data.

Soft Keys
A row of eight unlabeled pressure-sensitive soft keys is located
directly below the screen. Each key generates an audible tone
when pressed and initiates a function defined by the screen label
currently displayed directly above it.

Standard Computer Keyboard: List Number - 07H96-01


The Standard Computer Keyboard connects to the rear of the Data
Station and contains a complete set of alphabetic, numeric, and
special function keys used for data entry and manipulation. The
F1 to F8 function keys on this keyboard correspond to the soft
keys on the Data Station.

Floppy Disk Drive


The Floppy Disk Drive accepts 3.5-inch high-density diskettes. It
is used to update the system software program and to download
data.

Brightness Control
The Brightness Control adjusts the brightness of the Data Station
screen.

Contrast Control
The Contrast Control adjusts the contrast of the Data Station
screen.

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System Description
Chapter 1 System Components

Rear Components
The rear components located on the Data Station and monitor are
depicted in the following figure. The functional description of
each component follows.

Monitor Monitor
Serial Number Video
Cable
Power
Outlet Soft Key
Connector Interface
Cable
Com 2/
CPU Serial RS 232
Number Label Com 1/
External
Fan Computer

Analyzer
Port
Monitor
Video
Cable
Port

Keyboard LPT 1
Data Station Graphics
Port Soft Key Printer
Power Plug Interface
Connector CPU Port
Monitor Port LPT 2
Voltage Power (“Touch” Port) Ticket Printer
Selector Port Port
Figure 1.9: Data Station — Rear Components

Monitor Serial Number Label

The Monitor Serial Number Label contains the manufacturer’s


serial number for the Monitor.

CPU Serial Number Label

The CPU Serial Number Label contains the manufacturer’s serial


number for the computer.

Soft Key Interface Cable


(“Touch” Port)
The Soft Key Interface Cable transmits the Monitor’s Soft Key
requests to the CPU for processing.

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System Description
System Components Chapter 1

Com 1/External Computer


The Com 1/External Computer port is used to connect the
Laboratory Information System (LIS) to the Data Station.

Fan
The Fan cools the Data Station computer.

Monitor Video Cable and Port


The Monitor Video Cable provides video input to the monitor.
It connects to the CPU Video Port.

COM 2/RS 232 Port


The RS-232 Port is used to connect the Laboratory Information
System (LIS) to the Data Station.

Analyzer Port
The Analyzer Port is used to connect the cable from the Data
Station to the Analyzer.

Graphics Printer Port


The Graphics Printer Port is used to connect the printer cable to
the Data Station for graphics printing.

Ticket Printer Port


The Ticket Printer Port is used to connect the printer cable to the
Data Station for ticket printing.

Keyboard Port
The Keyboard Port is used to connect the Standard Computer
Keyboard to the Data Station.

Data Station Power Plug Connector


The Data Station Power Plug Connector is used to connect the
Main Power Cord to the Data Station.

Voltage Selector
The Voltage Selector sets the line voltage for the Data Station.

Monitor Power Cord and Plug Connector


The Monitor Power Cord supplies power to the Monitor. It
connects to the Monitor Power Plug Connector. The Power cord
insulation rating is SVT/FT2.

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System Description
Chapter 1 System Components

Flat Panel Display


A 15-inch, color-active matrix thin-film-transistor (TFT) liquid
crystal display (LCD) panel with high contrast 16.777M color
illumination displays all alphanumeric and graphic data.

1 2 3 4 5 6
Figure 1.10: Control Button – Front View

Touch Screen
The Touch Screen allows commands to be transferred from the
Flat Panel Monitor to the Data Station computer. A row of eight
touch keys is displayed on the screen. Each key generates an
audible tone when pressed and initiates the function defined by
the screen label.

Screen Controls
Controls are described in order from left to right.

1. Earphone – enables the user to connect a headset.


2. Auto Tuning – automatically sizes, centers and fine-tunes the
video signal to eliminate noise and distortion.
NOTE: Refer to the procedure following the description
of the controls.
3. On Screen Display (OSD) menu/select – displays the OSD
menus and is used to select from the displayed options.
4. Decrease – used to decrease the value of a selected OSD
option.
5. Increase – used to increase the value of a selected OSD
option.
6. Power switch – powers the Flat Panel Monitor ON or OFF.

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System Description
System Components Chapter 1

Auto Tuning Procedure


Perform this procedure to automatically size, center and fine-tune
the video signal to eliminate noise and distortion.

1. Be sure the Analyzer is in the READY state and the


appropriate software language has been selected.
2. From the MAIN MENU screen, press QUALITY CONTROL
(F5 on the keyboard).
3. Select a QC file that contains at least one entry and press
VIEW QC LOG (F3 on the keyboard).
4. Press the Auto tuning button on the front of the LCD panel.
The display will automatically be sized, centered and the
video signal fine-tuned. Additionally, the 8-switch function
soft keys location is optimized and the touch keys made
ready for use.

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System Description
Chapter 1 System Components

Flat Panel Display, Rear Components

Figure 1.11: Inputs Diagram

Cable Connections
Cable connections are described in order from left to right.

1. Power AC In – AC power input for 110/220 VAC power


2. 8-Switch/RS232 – 8-switch or RS232 25-pin touch screen.
Note that the RS232 is for the use of ELO’s serial touch screen
driver, AccuTouch (cable required).
3. PC In – VGA video input
4. USB – optional USB port for connecting ELO’s serial touch
screen driver, AccuTouch, supported by a virtual COM port
(VCP) driver from FTDI.
5. Audio – optional audio port (Line In) that can be connected
to any stereo audio out source
6. RS232/USB – optional switch used to select RS232 or USB
that must be set for RS232 or USB bidirectional
communication only.

Power Cord (not shown)


The AC power cord (Quail Series 1090 or equivalent) connects the
monitor to the power source.

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9140320F — April 2007
System Description
System Components Chapter 1

Touch Screen Cable (not shown)


The Touch Screen cable (shielded 9 conductor, 24 AWG stranded)
connects to the TOUCH port.

Video Cable (not shown)


The video cable (shielded 15 conductor, 24 AWG stranded)
connects to the VGA port.

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System Description
Chapter 1 System Components

Printer
The Printer is discussed in detail in Chapter 11: Printers.

Sample Loader
The Sample Loader is discussed in detail in Chapter 12: Sample
Loader.

Reagent System
Overview
The Reagent System is formulated specifically for the CELL-DYN
3700 instrument flow systems in order to provide optimal system
performance. Use of reagents other than those specified in this
manual is not recommended as instrument performance can be
affected. Each CELL-DYN System is checked at the factory using
the specified reagents and all performance claims were generated
using these reagents.

Reagents must be stored at room temperature to ensure optimal


performance. All reagents should be protected from direct
sunlight, extreme heat, and freezing during storage. Temperatures
below 32°F (0°C) may cause reagent layering that changes the
tonicity and conductivity of the reagents.

CAUTION: If any reagent has been frozen, it should not


be used.

The Reagent Inlet Tubes have a cap attached that minimizes


evaporation and contamination during use. However, reagent
quality may deteriorate with time. Therefore, use all reagents
within the dating period indicated on the label.

NOTE: Never add remaining reagent from a container


being replaced to a freshly opened container. This may
contaminate the new reagent.

Before operating the instrument for the first time, make sure each
reagent line is connected to the appropriate inlet and reagent
container.

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9140320F — April 2007
System Description
System Components Chapter 1

A facsimile of the label that is on the reagent panel is shown below


in Figure 1.12.

CAUTION: Do not handle Solution Container unless properly protected.


VORSICHT: Die Reagenzbeh lter nur ordnungsgem  gesichert bewegen.
ATTENTION : Ne pas manipuler le flacon de solution sans protection
approprie.
PRECAUCIN: no maneje el recipiente de la solucin a menos que est protegido adecuadamente.
ATTENZIONE: Non maneggiare il recipiente della soluzione se non si  protetti in modo adeguato.
ATENO: n o manipular o recipiente da solu o sem estar devidamente protegido.
VIGTIGT: Beholderen med oplsning m ikke hndteres, medmindre brugeren er korrekt beskyttet.
VIKTIGT: Anv nd skyddskl der vid hantering av lsningsbehllarna.
ΠΡΟΣΟΧΗ: Χρησιμοποιείτε το Δοχείο Ρυθμιστικού διαλύματος μόνο αφού λάβετε τις
κατάλληλες προφυλάξεις.
UPOZORNĚNÍ: Nemanipulujte s nádobou obsahující roztok, pokud není řádně zabezpečena.
Consult instructions for use. / Gebrauchsanweisung beachten. / Consulter les instructions
d’utilisation. / Consulte las instrucciones de uso. / Consultare le istruzioni per l’uso. /
Consultar as instru
es de utiliza o. / Se brugsanvisningen. / L s tillhrande
dokumentation. / Συμβουλευτείτε τις οδηγίες χρήσης. / Viz návod k použití.
PN 9230334F

Figure 1.12: Caution Label

CELL-DYN Reagents

Diluent
CELL-DYN Diluent is formulated to meet the following
requirements:
• Act as the Diluent for the WBCs (for the Impedance count
only), RBCs, PLTs, and HGB.
• Maintain the stable diluted cell volume of each red cell and
platelet during the count and sizing portion of the
measurement cycle.
• Provide acceptable background counts equal to or less than:
WIC: 0.30 x 103/µL (109/L)
RBC: 0.03 x 106/µL (1012/L)
PLT: 10.0 x 103/µL (109/L)
HGB: 0.2 g/dL (g/L)

HGB/WIC Lyse
CELL-DYN HGB/WIC Lyse is formulated to meet the following
requirements:

• Rapidly lyse the red blood cells and minimize the resultant
stroma.
• Strip the white cell cytoplasm leaving the nuclear membrane
intact so the white cell nuclei can be enumerated.
• Convert hemoglobin to a modified hemiglobincyanide
complex that is measurable at 540 nm. (The quaternary
ammonium lysate participates as a chromagen.)

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9140320F — April 2007
System Description
Chapter 1 System Components

CN-Free WIC/HGB Lyse


CELL-DYN Cyanide-Free WIC/HGB Lyse is formulated to meet the
following requirements:
• Rapidly lyse the red blood cells and minimize the resultant
stroma.
• Strip the white cell cytoplasm leaving the nuclear membrane
intact so the white cell nuclei can be enumerated.
• Convert hemoglobin to a single chromagen that is
measurable at 540 nm.
• Provide a background count equal to less than 0.2 g/dL.

Detergent
CELL-DYN Detergent is formulated to meet the following
requirements:

• Provide an optically clear solution that is needed to obtain


the zero reference during the HGB measurement cycle.
• Provide proper meniscus formation in the WIC and RBC/PLT
Metering Tubes and maintain it during each run cycle.
• Rinse the WIC Counting Chamber, the WIC Metering Tube,
RBC/PLT Counting Chamber, the RBC/PLT Metering Tube,
and the HGB Flow Cell with minimal bubble formation.

Sheath Reagent
CELL-DYN Sheath Reagent is formulated to meet the following
requirements:
• Osmotically lyse the red cells.
• Maintain the light scattering properties of the WBCs for the
duration of the measurement period.
• Serve as a Sheath fluid for the hydrodynamic focusing
process.
• Provide sufficient wetting action to prevent accumulation of
air bubbles in the WOC flow system.
• Provide a WOC background count equal to or less than
0.3 x 103/µL (109/L).

Enzymatic Cleaner
CELL-DYN Enzymatic Cleaner is formulated to effectively remove
protein buildup within the instrument.

CELL-DYN® 3700 System Operator’s Manual 1-29


9140320F — April 2007
System Description
System Components Chapter 1

Reticulocyte Reagent System


The CELL-DYN Reticulocyte Reagent is formulated specifically for
the CELL-DYN 3700 Reticulocyte Procedure in order to provide
optimal system performance. Use of reagents other than those
specified in this manual is not recommended, as instrument
performance can be affected. Each CELL-DYN 3700 System is
checked at the factory using the specified reagents and all
performance claims were generated using these reagents.
Reagent must be stored in the dark at a room temperature of
15-30°C. All reagents should be protected from direct sunlight,
extreme heat, and freezing during storage.
CAUTION: If any reagent has been frozen, it should not be
used.

Reagent tubes have been capped to minimize evaporation.


However, reagent quality may deteriorate with time. Therefore,
use all reagents within the dating period indicated on the label.

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System Description
Chapter 1 Controls and Calibrator

Controls and Calibrator

Controls and Calibrator are reference materials used to test, set,


and monitor CELL-DYN 3700 performance.

Controls
Day-to-day verification of System calibration is performed using
CELL-DYN controls. Running these stabilized reference products
every day of operation is recommended to test instrument
accuracy.

NOTE: Always store controls and calibrators according to


the directions in the package inserts that accompany them.

Calibrator
Calibration of the directly measured parameters can be performed
using CELL-DYN Calibrators. Calibration is discussed in detail in
Section 6: Calibration Procedures.

CELL-DYN® 3700 System Operator’s Manual 1-31


9140320F — April 2007
System Description
Controls and Calibrator Chapter 1

NOTES

1-32 CELL-DYN® 3700 System Operator’s Manual


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Chapter 2 Installation
Installation

Overview

The CELL-DYN 3700 System should only be installed by an


authorized Abbott representative to ensure that all system
components are functioning correctly and to verify system
performance.

NOTE: Installation of the Analyzer by an unauthorized or


untrained person could result in damage to the system.
Never attempt to install the system without an authorized
Abbott representative present. Additionally, all service and
repair must be performed by authorized ABBOTT
TRAINED Abbott representatives.

This chapter contains general installation, inventory, package


inspection, and relocation information. It also provides space,
waste, and power requirements for installing the CELL-DYN 3700
System, and it includes procedures for setting up the Sample
Loader and for installing the Graphics Printer and optional Ticket
Printer.

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9140320E — September 2004
Installation
Overview Chapter 2

NOTES

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Chapter 2 Installation

Initial Preparation

Inventory
The instrument is shipped from the factory with the following:

CELL-DYN 3700SL System


• 1 crate containing the Analyzer with Sample Loader
• 1 crate containing the Data Station
• Monitor
• CPU
• 1 box containing the Accessory Kit
• 1 box containing the Color Graphics Printer
• Optional: 1 box containing the Ticket Printer

CELL-DYN 3700CS System


• 1 crate containing the Analyzer
• 1 crate containing the Data Station
• 1 box containing the Color Graphics Printer
• 1 box containing the Accessory Kit
• Optional: 1 box containing the Ticket Printer

Package Inspection
All crates should be inspected for damage. If there is any damage, or if
any crates or boxes are missing, call Abbott Diagnostics Customer
Service for assistance (at 1-877-4ABBOTT in the US).
The reagents needed for installation may be shipped separately
from the instrument. This shipment includes: Diluent, HGB/WIC
Lyse Reagent, Sheath Reagent, and Detergent.
The calibrator and controls needed for the installation may be
shipped separately from the instrument.
The Enzymatic Cleaner is shipped separately.

CELL-DYN® 3700 System Operator’s Manual 2-3


9140320E — September 2004
Installation
Initial Preparation Chapter 2

Space Requirements
The CELL-DYN 3700 System requires approximately five linear
feet of space on a countertop. In addition, sufficient space is
required beneath for Diluent, WIC/HGB Lyse, Sheath Reagent,
Detergent, and the waste container (if one is used).

Six inches of space behind and on the left side of the Analyzer
must be allowed for air flow in order to maintain the constant
circulating internal air stream required to cool circuitry and
components whenever the power is ON. Six inches of space must
also be allowed behind the Data Station for air flow. The Data
Station may be placed in direct contact with the right side of the
Analyzer. If possible, there should be 24 inches of space above and
to either side of the Analyzer for service access.

Allow adequate space around the instrument to perform necessary


maintenance procedures, to provide service access, and to allow
the instrument to be easily disconnected from its power source.

In addition to these space requirements, the instrument should


also be located:

• On a stable, level surface.


• On a nonporous, nonabsorbing work surface and flooring
that can be easily cleaned and disinfected using
recommended procedures.
• Away from direct sunlight.
• Away from the path of a cooled or heated air outlet.
• Away from any other equipment that may interfere with it,
such as a centrifuge, any x-ray equipment, a CRT, a video
terminal, a computer, or a copier.
Please note that the CELL-DYN 3700 System has been evaluated to
EN 55011 and EN 61000 for electromagnetic emissions and
immunity, respectively.
Always place the reagents below (never above) the instrument.

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Installation
Chapter 2 Initial Preparation

Waste Requirements
A suitable properly labeled waste container must be located near
enough to the CELL-DYN 3700 System to connect to the Analyzer
Waste Outlet Tube, or the instrument must be positioned to
permit the waste to be routed directly to a drain. The drain must
be suitable for disposal of waste with possible biological and
chemical hazard. Ensure that the waste outlet tube is secured in
the drain hole and all System Components are located away from
possible waste overflow.
Regulations on permissible substances, and their amounts, for
disposal in public sewer systems vary from state to state and even
community to community. Customers are advised to be
knowledgeable of all applicable local, state, and federal
requirements, and the contents of the effluent streams, before
disposing of waste in public sewer systems.
Make sure the waste line is connected to the appropriate outlet
and routed to a suitable waste container or drain. If the waste is
routed to a waste container, make sure the Waste Sensor is
properly connected.
If an external waste container is used, the Waste Full Sensor Plug
(attached to the cap’s electrode wires) should be inserted into the
Waste Sensor Connector on the Left Side Panel of the Analyzer. If
the waste tube is placed directly into a drain, the “Dummy” Plug
provided in the Accessory Kit must be inserted into the Waste
Sensor Connector or the EXTERNAL WASTE FULL alert will be
activated.

NOTE: If a Waste Container is used, the container should


be labeled with the Biohazard Symbol.

Power Requirements
Three power outlets are required for the CELL-DYN 3700SL System
and three are required for the CELL-DYN 3700CS System. A
grounded power outlet and voltage regulator are required for
optimum performance. Refer to Chapter 4: System Specifications
for the electrical requirements for each system.

CELL-DYN® 3700 System Operator’s Manual 2-5


9140320E — September 2004
Installation
Initial Preparation Chapter 2

NOTES

2-6 CELL-DYN® 3700 System Operator’s Manual


9140320C — November 2000
Chapter 2 Installation

Printer Installation

Overview
Remove the printer(s) from its shipping container and visually
inspect it for damage. Find a suitable location adjacent to the
instrument. Be sure the printer power switch is in the OFF
position. Retain the manuals shipped with the printer(s) and store
them in a convenient location.

NOTE: If the printer is placed on top of the instrument,


be sure that the paper does not restrict air flow to the rear
panel fan.

Basic installation procedures follow for the Graphics and Ticket


Printers. When used with the CELL-DYN 3700, the Graphics
Printer prints color or black-and-white graphic reports and the
Ticket Printer prints tickets or black-and-white graphic reports.
Depending on the output desired, one or both printers may be
connected to the instrument.

Follow installation instructions carefully to be sure that the


printer(s) is connected to the correct port. (See Figure 2.1.) For
convenience, general instructions are provided for loading
individual pre-printed tickets in the Ticket Printer. For a detailed
description of the printer components and operating instructions,
refer to the manuals that accompany the printer.

IMPORTANT: The CELL-DYN 3700 System has been configured


for and tested with specific printers, such as the printer shipped
with the analyzer. For additional information about specific
printer capability with the CELL-DYN 3700 System, US Customers,
please contact Abbott Diagnostics Customer Service at
1-877-4ABBOTT (1-877-422-2688). Customers outside the US
should contact your local Customer Service representative. Use of
printers other than those recommended by Abbott Laboratories
may lead to erroneous printer functionality.

CELL-DYN® 3700 System Operator’s Manual 2-7


9140320F — April 2007
Installation
Printer Installation Chapter 2

Monitor Monitor
Serial Number Video
Cable
Power
Outlet Soft Key
Connector Interface
Cable
Com 2/
CPU Serial RS 232
Number Label Com 1/
External
Fan Computer

Analyzer
Port
Monitor
Video
Cable
Port

Keyboard LPT 1
Data Station Graphics
Port Soft Key Printer
Power Plug Interface
Connector CPU Port
Monitor Port LPT 2
Voltage Power (“Touch” Port) Ticket Printer
Selector Port Port
Figure 2.1: Data Station Rear Components

Graphics Printer Installation Procedure


1. Assemble the printer as directed in the printer manual.
2. Make sure that the printer power switch is OFF. Plug the
power cord into the printer. Do not plug the other end into
an outlet until you are ready to load paper.
3. Make sure that the power to the Data Station is turned OFF.
Remove the printer cable (which looks like a power cord with
two connectors) from the Accessory kit and plug one end
into the LPT1 port on the rear of the printer. Fasten the wire
clips to the connector for a secure connection.
4. Plug the other end of the printer cable into the Graphics
Printer port on the back of the Data Station. (See Figure 2.1)
Tighten the screws on the connector for a secure connection.
NOTE: This port is configured for use as a graphics
printer only. To print tickets, you may connect a Ticket
Printer to the Ticket Printer port.

5. Install the ink cartridge as directed in the printer manual.


6. Load the paper as directed in the printer manual.
2-8 CELL-DYN® 3700 System Operator’s Manual
9140320F — April 2007
Installation
Chapter 2 Printer Installation

Self-Test Printouts
Run any self-test printouts (as directed in the printer manual)
before using the printer for the first time. These self-tests may be
run any time to verify proper printer operation.

IMPORTANT The CELL-DYN 3700 software automatically controls and adjusts


most print conditions for the Graphics Printer, including page
width. If printing is not what you expect, refer to the printer
manual for guidance in making adjustments. If you have
additional questions or experience any problems, call Abbott
Customer Service for assistance.

CELL-DYN® 3700 System Operator’s Manual 2-9


9140320F — April 2007
Installation
Printer Installation Chapter 2

Ticket Printer Installation Procedure


The Ticket Printer is an OKIDATA MICROLINE 320 dot matrix
printer or compatible printer.

The Ticket Printer is normally used to print result data on blank or


pre-printed tickets but can be used to print a complete graphics
report on continuous tractor-feed paper. (Blank tickets are
available in continuous tractor-feed sheets. Pre-printed tickets
must be loaded individually.)

1. Assemble the printer as directed in the printer manual.


2. Make sure that the printer power switch is OFF. Plug the
power cord into the back of the printer and plug the other
end into a grounded outlet.
3. Make sure that the power to the Data Station is turned OFF.
Remove the printer cable (which looks like a power cord with
two connectors) from the Accessory kit and plug one end
into the port on the rear of the printer. (The port is
constructed so that the connector will only fit in the proper
way.) Fasten the wire clips to the connector for a secure
connection.
4. Plug the other end of the printer cable into the LPT2 Ticket
Printer port on the back of the Data Station. (See Figure 2.1.)
Tighten the screws on the connector for a secure connection.
NOTE: This port is configured for use as a ticket printer
only. To print graphics reports, you may connect a
Graphics Printer to the Graphics Printer port.

5. Install the ribbon as directed in the printer manual.


6. Load the paper or blank, continuous-feed tickets as directed
in the printer manual, OR, if you are using pre-printed
individual tickets, continue with the following procedure.

Loading Individual Tickets in the Ticket Printer


Instructions are given for loading individual tickets. If fanfold,
continuous-feed tickets are used, they should be loaded as
directed in the printer manual for tractor-feed paper.

NOTE: To print on these tickets, the printer cable must be


connected to the Ticket Printer Connector.

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9140320F — April 2007
Installation
Chapter 2 Printer Installation

1. Be sure that the printer is turned ON and the printer cable is


connected to the Ticket Printer connector on the back of the
Data Station. If the connection is incorrect, turn the Data
Station power OFF, change the position of the cable and turn
the power back ON.
2. Set the ribbon cartridge headgap lever to adjust for the
thickness of the tickets. Refer to the printer manual for
detailed instructions.
3. Move the paper selection lever to the rear position to select
single-feed paper.
4. Open the access cover and be sure the guide wire on the
paper separator is pushed back into the locked position.
5. Raise the separator to its upright position.
6. Place a ticket on the paper separator and adjust the guides so
that they barely touch the edges of the ticket.
7. Pull the bail lever forward. The ticket will automatically feed
into place. Release the bail lever.
8. Be sure the printer is deselected (Sel indicator is not
illuminated). Set the Top of Form by pressing and holding
the TOF/Quiet key and pressing the Form Feed key to move
the ticket up or pressing the Line Feed key to move the ticket
down. (The ticket moves in very fine increments so it can be
precisely positioned.)
NOTE: The ticket will only move down to a certain point
to prevent potential ticket jams. Do not move the top of
the page below the paper bail.

9. Position the ticket so that the lower red line on the paper
shield (located between the print head and the paper) is
positioned where the first line of printing should occur.
NOTE: When the Top of Form is set, the position is
retained in the printer memory until it is reset.

10. Press the Sel key to select the printer. The printer is now
ready to print.

Self-Test Printouts
Run any self-test printouts indicated in the printer manual before
using the Ticket Printer for the first time. These self-tests may be
run any time to verify proper printer operation.

CELL-DYN® 3700 System Operator’s Manual 2-11


9140320F — April 2007
Installation
Printer Installation Chapter 2

Sample Loader Set Up


The Sample Loader for the CELL-DYN 3700SL System is attached to
the analyzer.

Figure 2.2: CELL-DYN 3700SL

Mechanical and Electrical Set Up


1. Inspect the Sample Loader module for damage.
2. Remove the power cord from the Accessory Kit, and inspect
the cord and connector for damage. Connect the cord to the
Power Connector on the Left Side Panel. Connect the three-
prong end to an available power outlet.
CAUTION: Do not turn the Sample Loader power ON.
Damage may result if the fluidics tubing has not been
connected.

3. Remove the Sample Loader Interface Cable (it looks like a


power cord with two connectors) from the Accessory Kit, and
inspect it for damage. Connect the appropriate end of the
cable to the port on the Left Side Panel of the Sample Loader
and secure the screws. Connect the cable’s other end to the
port labeled Auto Sampler on the Left Side Panel of the
Analyzer. Secure the screws.

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9140320F — April 2007
Installation
Chapter 2 Printer Installation

Tube Racks Set Up


1. Remove the 11 Tube Racks from the Accessory Kit and
inspect each one for damage.
2. Remove the bar code labels provided for the Tube Racks and
inspect them for damage. Apply a bar coded rack ID label to
the indented area on the side of each tube rack between tube
positions 1 and 2. Apply the label by starting at the top and
working downward. Be sure the label is positioned in the
indentation. It is suggested that the racks be labeled 1–10 and
the End Rack be labeled 99.
3. Apply the rack ID number label as shown in the following
figure, inside the recessed area provided on the top of the rack.
4. On one rack only, apply the black End Rack Sensor Label to the
indented area on the side of the rack, and apply two black End
Rack Visual Indicator Labels to the indented areas on top of the
rack. These labels will identify this rack as the End Rack.

Black End Rack Visual Indicator Label


Bar Coded (END RACK ONLY)
Position Rack ID
ID Label Number
Label

Tube
Rack

Bar Coded Rack


ID Label

Orient Numbered End Black End Rack Sensor Label


DOWNWARD (END RACK ONLY)

Figure 2.3: Tube Rack Showing Label Placement Locations

5. Place five racks in the open area to the left of the tower and
five racks in the open area to the right of the tower. Push all of
the right side racks toward the Analyzer. Pull all of the left side
racks away from the Analyzer. All ten racks must be in place
for proper operation.

CELL-DYN® 3700 System Operator’s Manual 2-13


9140320F — April 2007
Installation
Printer Installation Chapter 2

NOTE: Be sure each rack is placed with its bar coded rack
ID label and open slot facing toward the Analyzer.

NOTE: Liquid spills in the rack drive mechanism are a


potential reason for failure of the rack to advance. Liquid
spills that flow in the Sample Loader Control Panel could
cause operational failure. For further assistance, call
Abbott Diagnostics Customer Service (at 1-877-4ABBOTT
in the US).

Power On
Turn the Sample Loader Power Switch on the Left Side Panel ON.
When the initialization process is complete, the light above the
Sample Loader Start key will flash. This indicates that the Sample
Loader is ready to start processing samples. The message AUTO
SAMPLER READY is displayed in the Data Station bulletin line.

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Installation
Chapter 2 Printer Installation

Instrument Installation
Reagent Tubing Installation

Materials
1. Lint-free pads
2. CELL-DYN Reagents

Procedure
1. Place the reagents in a suitable location below the Analyzer.
Sufficient space is required below for Diluent, WIC/HGB
Lyse, Sheath Reagent, Detergent, and the waste container
(if one is used).
NOTE: Never place the reagents above the Analyzer, in
direct sunlight, or in the path of a cooled or heated air
outlet.

2. Remove the Reagent Inlet Tubing and the Waste Tubing from
the Accessory Kit.
3. Inspect each length of tubing carefully for damage or cracks.
4. Attach the non-weighted end of the Detergent Tubing (the
tubing with the green label) to the Green Detergent Fitting
on the Left Side Panel of the Analyzer. (See the following
figure.) Wipe the outside of the tubing with a damp lint-free
pad and place the weighted end into the container of
CELL-DYN Detergent. Secure the cap.
5. Attach the non-weighted end of the Diluent Tubing (the
tubing with the red label) to the Red Diluent Fitting on the
Left Side Panel of the Analyzer. Wipe the outside of the
tubing with a damp lint-free pad and place the weighted end
into the container of CELL-DYN Diluent. Secure the cap.
6. Attach the non-weighted end of the WIC/HGB LYSE Tubing
(the tubing with the blue label) to the Blue WIC/HGB Lyse
Fitting on the Left Side Panel of the Analyzer. Wipe the
outside of the tubing with a damp lint-free pad and place the
weighted end into the container of CELL-DYN WIC/HGB
Lyse. Secure the cap.
7. Attach the non-weighted end of the Sheath Tubing (the
tubing with the purple label) to the Purple Sheath Fitting on
the Left Side Panel of the Analyzer. Wipe the outside of the
tubing with a damp lint-free pad and place the weighted end
into the container of CELL-DYN Sheath. Secure the cap.

CELL-DYN® 3700 System Operator’s Manual 2-15


9140320F — April 2007
Installation
Printer Installation Chapter 2

Waste Sensor
Connector

Waste Outlet
Fitting

Normally Closed
Valves

Figure 2.4: Left Side Panel

Waste Tubing Installation


Follow the appropriate procedure below.

Procedure If Using Waste Container


1. Attach the Waste Outlet Tubing to the Waste Outlet Fitting,
located on the Left Side Panel. (See the preceding figure.)
2. Place the other end of the tubing (cap and sensor) into the
waste container.
NOTE: The Waste Container should be labeled with the
Biohazard Symbol.

3. Secure the cap and sensor.


4. Ensure that the waste container is adequately labeled.
5. Locate and insert the Waste-Full Sensor Plug (attached to the
cap) into the Waste Sensor Connector, located on the Left
Side Panel of the Analyzer. Attach cable shielding connector
to ground plug.
NOTE: If no plug is inserted into the Waste Sensor
Connector, the External Waste Full message will be
displayed.

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Installation
Chapter 2 Printer Installation

Procedure If Using External Drain


1. Remove the cap and sensor from the Waste Outlet Tubing
and place the tubing into a drain suitable for the collection
of waste with possible biological and chemical hazard.
2. Insert the “Dummy” Plug (provided in the Accessory Kit)
into the Waste Sensor Connector, located on the Left Side
Panel of the Analyzer.
NOTE: If no plug is inserted into the Waste Sensor
Connector, the External Waste Full message will
activate.

3. Fasten the tubing to the drain securely to prevent accidental


spillage.

Normally Closed Valves


Before shipment, the tubing for the Normally Closed Valves is
removed. (See the preceding and following figures.) Follow the
directions below to reinstall the tubing.
1. Locate one of the Normally Closed Valves. Fully stretch one
length of the tubing and insert it into the top of the valve’s
slot. Work the stretched tubing vigorously back and forth
with a flossing motion, until it is completely seated in the
bottom of the slot.
2. Repeat step 1 for each of the remaining Normally Closed
Valves.

CELL-DYN® 3700 System Operator’s Manual 2-17


9140320F — April 2007
Installation
Printer Installation Chapter 2

Normally Closed
Valves

Figure 2.5: Front Flow Panel

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9140320F — April 2007
Installation
Chapter 2 Relocation

Relocation

Your CELL-DYN 3700® System has some fragile components, and


you must follow this relocation procedure to ensure proper
instrument function after relocation.

1. Shut down the system according to the procedure described


in Chapter 9: Maintenance, Subsection: Special Procedures,
Preparation for Inactivity or Shipping.
2. Prepare the new location site before moving the system.
Refer to the following subsections within Initial Preparation
at the beginning of this chapter:
• Space Requirements
• Waste Requirements
• Power Requirements
3. Move the CELL-DYN 3700 System to the new location.
CAUTION: The CELL-DYN 3700SL weighs 288 pounds
and the CELL-DYN 3700CS weighs 190 pounds. Obtain
assistance when moving and/or use a mechanical lifting
device.

4. Install the system in the new location according to


Installation within this chapter.
5. Turn the system ON according to the process described in
Chapter 10: Troubleshooting: Troubleshooting Procedure,
Power ON.
NOTE: All system and hematology data file information is
saved when power to the system is removed, including
date, time, and calibration. However, if new reagents are
installed upon relocation the appropriate Reagent Logs
should be updated, and instrument performance
confirmed as described below, before running any patient
samples.

6. Run five backgrounds and confirm that they are acceptable


before running controls or patient samples. If backgrounds
or controls are unacceptable, refer to Chapter 10:
Troubleshooting and follow established laboratory operating
procedures.

CELL-DYN® 3700 System Operator’s Manual 2-19


9140320F — April 2007
Installation
Relocation Chapter 2

NOTES

2-20 CELL-DYN® 3700 System Operator’s Manual


9140320F — April 2007
Chapter 3 Principles of Operation
Principles of Operation

Overview

The principles used by the CELL-DYN® 3700 System to measure,


count, and calculate the hematologic parameters are discussed
generally in the first section of this chapter as part of an overview
of the four measurement cycles. The parameters are then
discussed individually in relation to the methodology used. At the
end of the chapter is a discussion of operational messages and
flags that pertain to the parameter measurements and data results.

Four independent measurements are used in the CELL-DYN® 3700


System to obtain the hematologic parameters.
• The WBC Optical Count (WOC) and the WBC Differential
data are measured in the Optical Flow channel.
• The WBC Impedance Count (WIC) is measured in one
Electrical Impedance channel.
• The RBC and PLT data are measured in a second Electrical
Impedance channel.
• The HGB is measured in the Spectrophotometric channel.
During each instrument cycle, the sample is aspirated, diluted,
and mixed, and the measurements for each parameter are
performed.

CELL-DYN® 3700 System Operator’s Manual 3-1


9140320F — April 2007
Principles of Operation
Overview Chapter 3

NOTES

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9140320F — April 2007
Chapter 3 Principles of Operation

Sample Aspiration

The CELL-DYN 3700 System performs whole blood sample


aspiration using two modes. The operator selects the desired
mode from the Data Station RUN Screen.

• The Open Sampler Mode is used to aspirate the sample from


a collection tube that has been opened and is held under the
Open Sample Aspiration Probe.
• The manual Closed Sampler Mode or automated Sample
Loader Mode is used to aspirate the blood directly from a
capped collection tube by piercing the tube stopper.
The aspiration volumes are:
Open Mode 130 µL ± 5%
Closed Mode (CS) 240 µL ± 5%
Sample Loader (SL) 355 µL ± 5%
Once the mode of aspiration has been selected, the whole blood
sample is aspirated into the Analyzer by the Aspiration Peristaltic
Pump. The pump aspirates the sample through the Shear Valve.
Optical sensors check the integrity of the sample stream.

CELL-DYN® 3700 System Operator’s Manual 3-3


9140320F — April 2007
Principles of Operation
Sample Aspiration Chapter 3

NOTES

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9140320F — April 2007
Chapter 3 Principles of Operation

Sample Analysis Cycle Overview

NOTE: Sample and reagent volumes given in this section


are stated as the nominal values. Slight differences
between instruments may cause these volumes to vary.
These differences are compensated for by factory-set
internal dilution factors.
To begin the sample analysis cycle, the sample is aspirated into the
Shear Valve. The Shear Valve then rotates in order to isolate the
whole blood sample into three segments:
• 32 µL for the WOC dilution
• 20 µL for the WIC/HGB dilution
• 0.74 µL for the RBC/PLT dilution

WBC Analysis
WBCs are analyzed in two separate channels: Optical (WOC) and
Impedance (WIC).

WOC Measurement
WBC Optical Count (WOC) measurement is performed as follows:
1. The WOC Sheath Syringe dispenses 1.6 mL of Sheath Reagent
through the Shear Valve, where it picks up the 32-µL WOC
sample segment.
2. The sample segment and sheath are then routed to the WOC
Mixing Chamber, where the dilution is bubble-mixed. The
final dilution is 1:51.
NOTE: The ratio 1:51 represents 1 part in a total of 51
parts, not 1 part plus 51 parts.
3. The WOC Peristaltic Pump transfers the WOC dilution from
the WOC Mixing Chamber to the Sample Feed Nozzle in the
WOC Flow Cell.
4. A stream of WOC Sheath Reagent is directed through the
Flow Cell.
5. The WOC Metering Syringe injects 78 µL of the WOC
dilution into the Flow Cell sheath stream. The dilution is
hydrodynamically focused into a narrow stream.
(Hydrodynamic focusing is discussed later in this chapter.)

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6. A laser beam is focused on the Flow Cell. As the sample stream


intersects the laser beam, the light scattered by the cells is
measured at four different angular intervals. (Light scatter is
discussed later in this chapter.)

WIC Measurement
WBC Impedance Count (WIC) measurement is performed as follows:
1. The WIC/HGB Diluent Syringe dispenses 5.25 mL of Diluent
through the Shear Valve, where it picks up the 20-µL WIC/HGB
sample segment.
2. The segment and Diluent are then routed to the Mixing
Chamber in the von Behrens WIC Transducer. At the same
time, the WIC/HGB Lyse Syringe delivers 0.75 mL of WIC/HGB
Lyse to the Mixing Chamber.
3. The dilution is then bubble-mixed. The final WIC/HGB
dilution is 1:301.
4. The dilution is pulled through the aperture by vacuum. A
process known as volumetric metering (discussed later in
this chapter) ensures that 200 µL of the dilution are used for
the measurement.
5. Electrical Impedance (discussed later in this chapter) is used
to count the WBCs as they traverse the aperture.
6. When the count portion of the cycle is completed, the aperture
is automatically cleaned by the Aperture Cleaning Circuit.

RBC/PLT Analysis
1. The RBC Diluent Syringe dispenses 7.2 mL of Diluent
through the Shear Valve, where it picks up the 0.74-µL
RBC/PLT sample segment.
2. The sample segment and Diluent are then routed to the Mixing
Chamber of the von Behrens RBC/PLT Transducer, where the
dilution is bubble-mixed. The final dilution is 1:9,760.
3. The dilution is pulled through the aperture by vacuum. The
volumetric metering process ensures that 100 µL of the
dilution are used for the measurement.
4. Electrical Impedance (discussed later in this chapter) is used
to count the RBCs and PLTs as they traverse the aperture.

Reticulocyte Analysis
Reticulocytes are discussed in Chapter 14: Reticulocyte Package.

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Hemoglobin Analysis
1. After 200 µL of the WIC/HGB dilution are metered through
the WIC aperture, the remaining dilution is transferred to
the HGB Flow Cell.
2. The HGB concentration is measured spectrophotometrically.
This process is discussed in detail later in this chapter.

Results Displayed
All data are transmitted to the Data Station for analysis. Results
are computed for all parameters and are displayed on the Data
Station RUN Screen. Results are also stored in a log format called
the Data Log.

Instrument Rinsed
1. The Open Sample Aspiration Probe is rinsed internally and
externally with Diluent.
2. The needle used in both the automated and the manual
Closed Mode is rinsed internally and externally with Diluent.
3. The WIC Mixing Chamber and the RBC/PLT Mixing
Chamber are rinsed with Diluent.
4. The WOC Mixing Chamber is rinsed with Sheath Reagent.
5. The WIC Metering Tube and the RBC/PLT Metering Tube are
rinsed with detergent.
6. The HGB Flow Cell is rinsed with detergent.

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NOTES

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WBC Analysis

Two WBC values are provided by the CELL-DYN 3700 System:


• The WIC (WBC Impedance Count)
• The WOC (WBC Optical Count)
The WOC is the primary value reported as the WBC count.
Whenever a clinically significant difference between WIC and
WOC is present, the data is further evaluated to determine the
most accurate value.

WIC/WOC Interaction
The WIC (WBC Impedance Count) interacts with the WOC (WBC
Optical Count) to produce the final reported WBC value. Two
methods are provided because both measurements have strengths
and limitations. Because the limitations of each method differ,
providing both methods enhances the instrument’s ability to provide
a more accurate WBC count in the presence of certain interfering
substances and pathological conditions. A data analysis algorithm
automatically evaluates each measurement and selects the
appropriate result to report. The algorithm used by the CELL-DYN
3700 System is divided into three main areas: 1) the WOC decision
tree, to analyze and output the WOC data; 2) the WIC decision tree,
to analyze and output the WIC data; and 3) a WIC/WOC comparison
decision tree, to compare the two outputs.
The WOC decision tree calculates the WOC result for the WBC
count and the Differential count. It evaluates the results for
correctness and flagging. Finally, the algorithm outputs the WOC
with appropriate flags to the WIC/WOC comparison decision tree.
The WIC decision tree evaluates the WIC for correctness and
flagging and outputs the WIC to the WIC/WOC comparison
decision tree.
The WIC/WOC comparison decision tree compares the two
outputs for a difference between the results. If a clinically
significant difference exists, results are further evaluated to
determine the cause. Depending on the nature of the cause (the
type of interference), the algorithm reports either the WOC value
or the WIC value, whichever is more accurate, with the
appropriate flags (or no flags) as the reported WBC.

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WIC Measurement
Overview
The WBC Impedance Channel is used for the determination of the
WIC. A 1:301 dilution of the sample is made with Diluent and
WIC/HGB Lyse. The WIC/HGB Lyse Reagent lyses the RBCs and
strips the cytoplasm from the WBCs. The WBC nuclei are counted
using the impedance method as they pass through the 100 x 77–µm
aperture in the von Behrens WIC Transducer. The 200-µL volume
of sample that is analyzed is precisely regulated by the WIC
Metering Assembly. WIC data are collected in 256 channels. The
WIC data may be presented in a histogram at the request of the
operator.

NOTE: If NRBCs are present, they are lysed and their


nuclei are included in the WIC. Consequently, when
NRBCs are present the WIC data provide a total nucleated
cell count including the NRBCs.

Electrical Impedance Measurements


WBC nuclei are counted and sized by the Electrical Impedance
method. This method is based on the measurement of changes in
electrical current which are produced by a particle, suspended in a
conductive liquid, as it passes through an aperture of known
dimensions. An electrode is submerged in the liquid on either side
of the aperture in order to create an electrical pathway through it.
As each particle passes through the aperture, a transitory change
in the resistance between the electrodes is produced. This change
produces a measurable electrical pulse. The number of pulses
generated is indicative of the number of particles that traversed
the aperture. The amplitude of each pulse is essentially
proportional to the volume of the particle that produced it.
Each pulse is amplified and compared to internal reference
voltage channels. These channels are delineated by calibrated size
discriminators to accept only pulses of a certain amplitude. Thus,
the pulses are sorted into various size channels according to their
amplitude.

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Coincidence Passage Correction


Two or more cells can enter the aperture sensing zone
simultaneously during a measurement cycle. The resistance
change created in this situation generates a single pulse with a
high amplitude and increased pulse area. Thus, it appears that one
large cell has passed through the aperture. Consequently, the cell
count is falsely decreased. This count reduction, referred to as
Coincidence Passage Loss, is statistically predictable because it has
a direct relationship to the effective volume of the aperture and
the amount of dilution. Each WIC is automatically corrected for
Coincidence Passage Loss.

Volumetric Metering
An absolute cell count cannot be obtained unless the precise
volume of diluted whole blood that passes through the aperture
during the count cycle is known.1 The CELL-DYN 3700 System
utilizes the Volumetric Metering process to regulate the count
cycle and ensure that a precise volume of sample is analyzed for
the WIC measurement.
The WIC Metering Assembly contains a precision-bore glass tube fitted
with two optical detectors. (See the following figure.) The distance
between the detectors is set to precisely measure 200 µL. Detergent is
added to the Diluent in the metering tube to create a meniscus in the
liquid. When the WIC cycle is initiated, the liquid flows down the
metering tube.

Start
Detector
(Count
Initiated)
Meniscus

Count
Time

Stop
Detector
(Count
Completed)

Figure 3.1: Volumetric Metering

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The count portion of the cycle is initiated when the meniscus


reaches the upper detector. The count cycle stops when the
meniscus reaches the lower detector. The amount of time required
for the meniscus to travel from the upper to the lower detector is
called the WIC Count Time. The computer also monitors the time
it takes the meniscus to reach the upper detector once the WIC
cycle is initiated. This is called the WIC Upper Metering Time.
The WIC Count Time (WCT) and the WIC Upper Metering Time
(WUT) are automatically monitored to detect variation from the
expected values. Variation may be caused by debris in the aperture,
vacuum fluctuation, or air bubbles in the metering tube. If
significant variation is detected, the bulletin line on the Data Station
RUN screen displays the message: WIC METERING FAULT — CLOG
or FLOW ERROR and the WBC and Differential data are suppressed.
At the end of each cycle, the WIC Count Time is displayed on the
Data Station RUN screen below and to the right of the BASO
results. If a WIC metering fault was detected, one of two messages
is displayed and printed: the WIC CLOG message if either time is
too slow or the WIC FLOW ERROR message if either time is too
fast. Both the WIC Upper Metering Time (WUT) and the WIC
Count Time (WCT) are printed when a WIC metering fault occurs.

WIC Measurement Process


The 1:301 WIC/HGB dilution is delivered to the Mixing Chamber
in the von Behrens WIC Transducer where it is bubble-mixed. A
200-µL metered volume of the dilution is drawn through the
100-µm aperture by vacuum. The WBCs are counted by
impedance. If the pulse generated is above the WBC lower
threshold (channel 40), it is counted as a WBC. The WIC count
data are also stored in a 256-channel histogram, in which each
channel is equal to 0.5 fL.
As cells exit from the aperture, they tend to swirl around and may
reenter the sensing zone and be counted a second time, causing
the counts to be falsely elevated. The von Behrens Plate located in
the von Behrens WIC Transducer Counting Chamber minimizes
the effect of these recirculating cells.
The WIC is corrected for Coincidence Passage Loss (discussed
earlier in this chapter) and compared to the WOC by the
algorithm.

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Chapter 3 WBC Analysis

WOC Analysis
The CELL-DYN 3700 System uses laser-based flow cytometric
techniques to analyze the WBC subpopulations. The first part of
this section gives a brief introduction to the principles of flow
cytometry.2 The second part of this section gives a detailed
description of the WOC measurement and the WBC differential
analysis.

Introduction to Laser-Based (Optical) Flow Cytometry


Flow Cytometry can be defined as “a process in which individual
cells or other biological particles are made to pass in single file in
a fluid stream by a sensor or sensors which measure physical or
chemical characteristics of the cells or particles.”3
Clinical and Laboratory Standards Institute (formerly NCCLS)
recently defined Flow Cytometry as “A methodologically oriented
subdiscipline of analytical cytology that measures cells in
suspension in a liquid vehicle as they pass typically one cell at a
time, by a measurement station. The measurement represents
transformations of changes in the output of a detector (or
detectors) due to changes in scattered light, absorbed light, or
light emitted (fluorescence) by the cell, or changes in electrical
impedance, as the cell passes through the measuring station.”4
Flow Cytometry enables the rapid screening of large numbers of
cells beyond the capability of traditional methods, and it provides
quantitative cell analysis at the single-cell level.
The basic components of a Flow Cytometer include the following:
• A sample collector and transporter
• A flow system
• A sensing zone
• Signal detectors
• Data collection and storage capabilities
• Data display and analysis capabilities
The CELL-DYN 3700 System uses optical flow cytometric
technology to obtain the WBC Optical Count (WOC) and analyze
the WBC subpopulations (neutrophils, lymphocytes, monocytes,
eosinophils, and basophils) for the WBC Differential.

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Various Angles
of Scattered Light

Focused
Laser Beam Sample Stream

Sheath Stream
Sample
Feed Nozzle

Figure 3.2: WOC Flow Cell

In a flow cytometer, the cell suspension is pumped from the


specimen container through a sample tube into a special flow
chamber with a small opening at the tip. The suspension is then
injected into a stream of fast-moving, cell-free liquid (sheath
fluid). Since the two liquids travel at different rates of speed, they
do not intermingle. This is called laminar flow. The special
geometry of the Flow Cell and the flow rate of the sheath fluid
forces the cells into single file. This process is known as
hydrodynamic focusing. (See the preceding figure for a drawing
of the WOC Flow Cell.)
As the cells enter the view volume (specific viewing area), they
interact with the laser beam. The cells scatter the laser light at
different angles, yielding information about cell size, internal
structure, granularity, and surface morphology. The optical
signals the cells generate are detected and converted to electrical
impulses which are then stored and analyzed by the computer.
Flow cytometers generally measure two angles of scatter. Forward
angle light scatter is roughly a measure of cell size. Right angle
(orthogonal) light scatter is a measure of cell surface and internal
structure but is primarily a measurement of internal granularity.
Combining the information from the two scatter measurements
provides more accurate discrimination between cell populations
than either single measurement.

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Focused Various Angles


Laser Beam of Scattered Light

90° Scatter
0° Scatter

90°D Scatter
10° Scatter

Figure 3.3: WBC Light Scatter

The CELL-DYN 3700 System measures four angles of scatter (see


the preceding figure):
• Forward Angle Light Scatter (measured at 0°), which can be
used to measure cell size
• Narrow-Angle Light Scatter (measured at 10°), which can be
used to measure cell complexity
• Orthogonal or Ninety-Degree Light Scatter (measured at
90°), which can be used to measure cell surface and internal
structure (lobularity)
• Orthogonal or Ninety-Degree Depolarized Light Scatter
(measured at 90°D, using a depolarizing filter), which can be
used to measure certain types of cell granularity
Combining the information from multiple scatter measurements
provides more accurate discrimination between cell populations
than any single measurement would provide.

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WOC Measurement Process


This section gives an overview of the WOC measurement. The
details are discussed in Detection with the Optical Bench and
WBC Differential Analysis within this chapter.
The Optical Channel is used for the determination of WOC data.
A 1:51 dilution of the sample is made with the Sheath Reagent. The
WOC Metering Syringe injects a metered volume of this dilution into
the sheath stream. The sample stream is then hydrodynamically
focused to align the cells in single file as they pass through the
WOC Flow Cell, which is an optically clear quartz chamber. A
vertically polarized Helium-Neon Laser is the light source.
The instrument measures the traditional forward angle light
scatter (1–3°, referred to as 0°) and orthogonal light scatter (70–110°,
referred to as 90°) parameters. Two additional scatters, narrow-
angle light scatter (7–11°, referred to as 10°) and ninety-degree
depolarized scatter (70–110°, referred to as 90°D), are measured.
This is referred to as MAPSS™ (for Multi-Angle Polarized Scatter
Separation) technology. Various combinations of these four
measurements are used to classify the WBC subpopulations and
provide morphological flagging.
NOTE: Data from the WIC channel are also used to
enhance the flagging algorithms.

The WBC count is determined by enumerating the number of


events above the computer-generated threshold in the 0° channel.
The information from all four measurements is used to
differentiate the WBCs into five subpopulations:
Neutrophils
Lymphocytes
Monocytes
Eosinophils
Basophils
The WOC data are presented graphically as a scatterplot. It may
also be presented in two histograms at the operator’s request.

Sheath Reagent
The Sheath Reagent is an integral part of the WOC analysis. WBCs
diluted in the Sheath Reagent maintain cellular integrity that is
close to their native state. The structure of the basophils changes
slightly due to the water-soluble nature of the basophilic granules.

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RBCs, however, are altered by the Sheath Reagent because the


osmotic pressure of the RBC is higher than that of the Sheath
Reagent. Therefore the hemoglobin in the RBC diffuses out of the cell
and water from the Sheath Reagent diffuses into the cell. The cell
membrane remains intact but the RBC now has the same refractive
index as the sheath, thereby rendering it invisible to the laser.

90° Light 90° Depolarized Helium-Neon Laser


Scatter Light Scatter (632.8 nm) Polarized
PMT PMT Polarizer Vertically
(Horizontal)
Front Beam
Surface Splitter
Mirror

Cylindrical
Lens
10° Light
700 μm Scatter
Slit Photodiode

Front
Surface
Mirror
0° Light
125 μm WBC Scatter
Vertical Imaging Flow Obscuration Photodiode
Slit Cell Bar Perforated
Lens Mirror

Figure 3.4: Optical Bench Assembly

Detection with the Optical Bench


The Optical Bench Assembly (depicted in the preceding figure)
contains the components that make up the Flow Cytometer. The
main purpose of the Optical Bench is to detect the light that is
scattered by the cells as they pass through the Flow Cell. The
detection process is discussed in this section.
The light source is a vertically polarized 5-mW Helium-Neon
Laser with a wavelength of 632.8 nm. The laser beam passes
through a cylindrical lens that changes the shape from a circle to
an ellipse. The beam is then directed through a 125-µm slit which
blocks the weaker outer edges. This process yields a uniformly
intense beam approximately 80 µm wide. Consequently, the cell
stream may wander slightly in the Flow Cell and yet still be
exposed to the same light intensity. An imaging lens centers the
focused laser beam onto the quartz Flow Cell.

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The WOC Metering Syringe slowly injects 78 µL of the WOC


dilution into the Sheath stream in the WOC Flow Cell. The sample
is hydrodynamically focused into a small stream approximately
30 µm in diameter. This focused stream aligns the diluted cells in
single file as they pass through the sensing region, which allows
them to be analyzed one at a time.
Since the average WBC is much smaller than the focused laser
beam, the cells do not scatter much laser light. If the remaining
so-called axial light were allowed to reach the 0° detector, it would
saturate the electronics. Therefore, it is blocked from the detector
by the obscuration bar. The forward angle scatter is directed to a
perforated mirror. The 0° light scatter passes through the mirror
to the 0° silicon photodiode detector. The 10° light scatter is
deflected off the mirror to the 10° silicon photodiode detector.
The orthogonal scatter is directed through a 700-µm slit, which
blocks the scatter from the walls of the Flow Cell. A beam splitter
then separates the orthogonal light scatter into two portions. One
portion of the light is directed to the 90° PMT (photomultiplier
tube). The remaining light is directed through a horizontal
polarizer. Only light that has changed polarization (depolarized
light) can pass through the polarizer to the 90°D PMT. (PMTs are
used because relatively little light is scattered at this high angle.)
The light signals collected by each detector are converted into
electrical signals or pulses. The pulses are digitized based on
intensity and sorted into 256 channels for each angle of light
measured.
If a pulse falls above the hardware threshold (channel 23) in the
0° detector, the cell counter counts the pulse and stores it for
further evaluation. Pulses that fall below this threshold are not
included in the count and, therefore, are not included in the
differential. If this raw count is estimated to be below a
predetermined value, the instrument automatically continues to
count WBCs for an extended count period. The results from the
two count periods are averaged.
The information from each detector is collected in list mode. This
format stores the channel information from each of the four
dimensions. The data are then used to determine the differential.

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WBC Differential Analysis


The light scatter information is graphically presented in the form
of scatterplots. (The data can also be presented in histograms,
available at the operator’s request.) Each cell analyzed is
represented by a dot on the scatterplot. The dots are plotted at a
point determined by the intersection of the channel information
designated on the X and Y axes. For example, if a cell falls in
channel 50 on the X axis and channel 50 on the Y axis, it is
plotted at the intersecting point of the two channels.
The scatter information may be plotted in various combinations to
yield different information. The CELL-DYN 3700 System uses the
scatterplots to differentiate the WBCs into five color-coded
subpopulations:
Neutrophils (yellow)
Lymphocytes (blue)
Monocytes (purple)
Eosinophils (green)
Basophils (white)
NOTE: The basophils are displayed as white dots but
appear as black dots on color printouts.

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WBC Scatterplots

Mononuclear – Polymorphonuclear Mononuclear – Polymorphonuclear


Separation Identification
90° Lobularity

90° Lobularity

10° Complexity 10° Complexity

Figure 3.5: Mononuclear-Polymorphonuclear Scatter

Mononuclear-Polymorphonuclear Separation
The scatter information is plotted with the 90° scatter on the
Y axis and the 10° scatter on the X axis. (The 90°/10° scatterplot
is shown in the preceding figure.) Two populations of cells are
clearly seen on the display. The mononuclear cells fall in the
cluster in the lower left corner of the scatterplot and the
polymorphonuclear cells fall in the cluster above and to the right
of them.
The instrument uses a dynamic threshold to determine the best
separation between the two populations. Each cell is then
identified as a MONO or a POLY. Once each cell is identified, it
retains this classification no matter where it appears on other
scatterplots.

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Neutrophil – Eosinophil Neutrophil – Eosinophil


Separation Identification
90° Depolarized Granularity

90° Depolarized Granularity

90° Lobularity 90° Lobularity

Figure 3.6: Neutrophil-Eosinophil Scatter

Polymorphonuclear Separation
The scatter information is plotted with the 90°D scatter on the
Y axis and the 90° scatter on the X axis. (The 90°D/90° scatterplot is
shown in the preceding figure.) Only the polymorphonuclear cells
are plotted on this scatterplot. The mononuclear cells have been
identified and therefore do not interfere in the further
classification of the polymorphonuclear cells.
Two populations of polymorphonuclear cells are clearly seen on
the display. The neutrophils fall in the lower of the two clusters.
The eosinophils fall in the upper cluster. The instrument uses a
dynamic threshold to determine the best separation between the
two populations. Each cell is then classified as a NEUT or an EOS.
All cells scatter a certain amount of 90°D light. The eosinophils
scatter more 90°D light than any of the other cells because of the
unique nature of granules they contain. This property of the
eosinophils is used to positively identify them and thus clearly
differentiate them from the neutrophil population.

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Mononuclear Mononuclear
Separation Identification
0° Size

0° Size

10° Complexity 10° Complexity

Figure 3.7: Mononuclear Scatter

Mononuclear Separation
The scatter information is plotted with the 0° scatter on the Y axis
and the 10° scatter on the X axis. (The 0°/10° scatterplot is shown
in the following figure.) The mononuclear cells are plotted on this
scatterplot. The algorithm also uses the orientation of the
neutrophil cluster to aid in classifying the mononuclears. Three
populations of mononuclear cells are clearly seen on the display.
There are three populations of mononuclears because basophils
are included in the mononuclear cluster. Typically, basophils are
granulated cells and therefore more complex than the
mononuclear cells. However, the basophilic granules are water
soluble and dissolve in the Sheath Reagent. Consequently, the
degranulated basophil becomes a less complex cell that falls into
the mononuclear cluster.

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The lymphocytes fall in the lowest large cluster. (The small


population of cells below the lymphocytes contains particles that
are unlikely to be WBCs.) The basophils fall in the cluster above
and slightly to the right of the lymphocytes. The monocytes fall
in the cluster above the lymphocytes and basophils. The
instrument uses dynamic thresholds to determine the best
separation between the three main populations. Each cell is then
classified as a LYMPH, a MONO or a BASO.
Finally, the instrument evaluates the area below the lymphocyte
cluster but above the hardware threshold (channel 23). Any
particles that fall in this area are separated from the lymphocytes
by a dynamic threshold. The following cell types may be present
in this region:
NRBCs
Unlysed RBCs
Giant PLTs
PLT clumps

NOTE: Information from the WIC channel is used to


assist in discriminating these particles.

All particles in this region are excluded from the WBC count and
the Differential.

Other Scatterplots
90°/0°
The scatter information is plotted with the 90° scatter on the
Y axis and the 0° scatter on the X axis.
90°D/0°
The scatter information is plotted with the 90°D scatter on the
Y axis and the 0° scatter on the X axis.
90°D/10°
The scatter information is plotted with the 90°D scatter on the
Y axis and the 10° scatter on the X axis.
All scatterplots may be displayed and printed at operator request.

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WBC Histograms
The CELL-DYN 3700 System can also present the WBC scatter
information as two histograms. The WIC can also be presented in
histogram format (shown in the following figure). These
histograms can be displayed and printed at the operator's request.

Figure 3.8: WBC Histograms

MONO-POLY Histogram
The Mononuclear-Polymorphonuclear Scatter information is
plotted with the relative number of cells on the Y axis and the
mononuclear and polymorphonuclear size distribution data on
the X axis.

NWBC-LYM-MONO Histogram
The Non-WBC-Lymphocyte-Monocyte Scatter information is
plotted with the relative number of cells on the Y axis and the
non-WBC, lymphocyte, and monocyte size distribution data on
the X axis.

WIC Histogram
The WIC data are plotted with the relative number of cells on the
Y axis and the WIC size distribution data on the X axis.

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WBC Parameters

Figure 3.9: WBC Data and Scatterplots

The WBC data are generally displayed as depicted in the preceding


figure. All numeric and graphical data are automatically displayed
on the Data Station RUN screen in the format selected by the
operator. After the WBC scatter information has been plotted and
the cells have been classified into the five subpopulations, the
instrument determines the WOC by counting the pulses above the
dynamic threshold in the 0° channel and comparing the data to
the WIC data. The algorithms then determine the WBC and the
percent of cells in each subpopulation.

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Principles of Operation
WBC Analysis Chapter 3

Once the WBC count is determined, the absolute number of cells


in each subpopulation is calculated by multiplying that WBC
count by the percentage. The results are expressed as follows:
WBC # x 103/µL (109/L)
NEU # x 103/µL (109/L) and %
LYM # x 103/µL (109/L) and %
MONO # x 103/µL (109/L) and %
EOS # x 103/µL (109/L) and %
BASO # x 103/µL (109/L) and %
The decimal point moves to display up to three decimal places for
the absolute number and percent.
The WBC scatter information is usually displayed in the two
scatterplots shown in the preceding figure:

SIZE/COMPLEXITY The size information (0°


scatter) is plotted on the Y
axis and the complexity
information (10° scatter) is
plotted on the X axis.

GRANLRTY/LOBULARITY The granularity information


(90°D scatter) is plotted on
the Y axis and the lobularity
information (90° scatter) is
plotted on the X axis.

WBC Flagging
For a detailed discussion of the WIC/WOC algorithm and all of
the WBC flagging messages, refer to Operational Messages and
Data Flagging within this chapter.

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Chapter 3 Principles of Operation

RBC/PLT Analysis

Overview
An impedance channel is used for the determination of RBC and
PLT data. A 1:9,760 dilution of the sample is made with the
Diluent. The cells are counted and sized using the impedance
method as they pass through the 60 x 70–µm aperture in the
von Behrens RBC/PLT Transducer. Dynamic thresholding separates
the PLTs from the RBCs. The 100-µL volume of sample that is
analyzed is precisely regulated by the RBC/PLT metering assembly.
Data is collected in 256 channels for both RBCs and PLTs.

Electrical Impedance Measurements


RBCs and PLTs are counted and sized by the Electrical Impedance
method. This method is based on the measurement of changes in
electrical current which are produced by a particle, suspended in a
conductive liquid, as it passes through an aperture of known
dimensions. An electrode is submerged in the liquid on either side
of the aperture in order to create an electrical pathway through it.
As each particle passes through the aperture, a transitory change
in the resistance between the electrodes is produced. This change
produces a measurable electrical pulse. The number of pulses
generated is indicative of the number of particles that traversed
the aperture. The amplitude of each pulse is essentially
proportional to the volume of the particle that produced it.
Each pulse is amplified and compared to internal reference
voltage channels. These channels are delineated by calibrated size
discriminators to accept only pulses of a certain amplitude. Thus,
the pulses are sorted into various size channels according to their
amplitude.

Coincidence Passage Correction


Two or more cells can enter the aperture sensing zone
simultaneously during a measurement cycle. The resistance change
created in this situation generates a single pulse with a high
amplitude and increased pulse area. Thus, it appears that one large
cell has passed through the aperture. Consequently, the cell count
is falsely decreased. This count reduction, referred to as
Coincidence Passage Loss, is statistically predictable because it has a
direct relationship to the effective volume of the aperture and the
amount of dilution. Each total cell count for RBCs and PLTs is
automatically corrected for Coincidence Passage Loss.

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Principles of Operation
RBC/PLT Analysis Chapter 3

RER
The RER (Red Cell Editing Ratio) is a process of pulse editing that
is applied to the RBC pulses before the MCV is derived. The
instrument compensates for the aberrant pulses produced by the
non-axial and coincidence passage of the RBCs through the
aperture. These pulses are included in the RBC count but
eliminated from the RBC sizing determination.

Volumetric Metering
An absolute cell count cannot be obtained unless the precise
volume of diluted whole blood that passes through the aperture
during the count cycle is known.1 The CELL-DYN 3700 System
utilizes the Volumetric Metering process to regulate the count
cycle and ensure that a precise volume of sample is used for the
RBC/PLT measurement.

Start
Detector
(Count
Meniscus Initiated)

Count
Time

Stop
Detector
(Count
Completed)

Figure 3.10: Volumetric Metering

The RBC/PLT metering assembly contains a precision-bore glass


tube fitted with two optical detectors. (See the preceding figure.)
The distance between the detectors is set to precisely measure
100 µL. Detergent is added to the Diluent in the metering tube to
create a meniscus in the liquid. When the RBC/PLT cycle is
initiated, the liquid flows down the metering tube.

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Chapter 3 RBC/PLT Analysis

The count portion of the cycle is initiated when the meniscus


reaches the upper detector. The count cycle stops when the
meniscus reaches the lower detector. The amount of time required
for the meniscus to travel from the upper to the lower detector is
called the RBC Count Time. The computer also monitors the time
it takes the meniscus to reach the upper detector once the
RBC/PLT cycle is initiated. This is called the RBC Upper Metering
Time. (For convenience, these times are referred to as “RBC” times.
Both times actually monitor the RBC/PLT metering process.)
The RBC Count Time (RCT) and the RBC Upper Metering Time
(RUT) are automatically monitored to detect variation from the
expected values. Variation may be caused by debris in the aperture,
vacuum fluctuation or air bubbles in the metering tube. If
significant variation is detected, the bulletin line on the Data Station
RUN screen displays the message RBC METERING FAULT-CLOG or
FLOW ERROR and the RBC and PLT data are suppressed.
At the end of each cycle, the RBC Count Time is displayed on the
Data Station RUN screen to the right of the MPV result. If an RBC
metering fault was detected, one of two messages is displayed and
printed: the RBC CLOG message if either time is too slow or the
RBC FLOW ERROR message if either time is too fast. Both the RBC
Upper Metering Time (RUT) and the RBC Count Time (RCT) are
displayed and printed when an RBC metering fault occurs.

RBC/PLT Measurement Process


The 1:9,760 RBC/PLT dilution is delivered to the mixing chamber
in the von Behrens RBC/PLT Transducer where it is bubble mixed.
A 100-µL metered volume of the dilution is drawn through the 60
x 70–µm aperture by vacuum. The RBCs and PLTs are counted by
impedance. If the pulse generated is above the PLT lower
threshold (1), it is counted as a PLT. If the pulse generated is above
the RBC lower threshold (35), it is counted as an RBC. There are
256 size channels for each of the parameters, each RBC size
channel being equivalent to 1 fL and each PLT size channel being
equivalent to 0.137 fL.
As cells exit from the aperture, they tend to swirl around and may
reenter the sensing zone and be counted a second time, causing
the counts to be falsely elevated. The von Behrens Plate located in
the von Behrens RBC/PLT Transducer counting chamber
minimizes the effect of these recirculating cells.
The RBC count is corrected for coincidence and the pulses are
edited by the RER before the MCV is derived. The PLT pulses are
analyzed by the PLT algorithm as discussed in PLT Measurement
within this chapter.

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Principles of Operation
RBC/PLT Analysis Chapter 3

RBC Parameters

Figure 3.11: RBC Data and Histogram

All numeric and frequency size distribution data are automatically


displayed on the Data Station RUN screen in the format selected. The
size distribution data for the red cells are displayed graphically as a
histogram with the distribution data plotted on the X axis and the
relative number of cells normalized and plotted on the Y axis. The
RBC data are shown in the preceding figure.

RBC Count
The red blood cell count (RBC count) is directly measured, gives
the number of RBCs, and is expressed as follows:
RBC = # x 106/µL (1012/L)
Counts below 1.0 x 106/µL (1012/L) are displayed to three decimal
places.
The RBC count is automatically corrected for the WBC count, and
the corrected RBC count is displayed on the main RUN screen.

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Chapter 3 RBC/PLT Analysis

MCV
The mean corpuscular volume (MCV) is the average volume of the
individual red blood cells. The MCV is derived from the RBC size
distribution data and is expressed in femtoliters.

HCT
The hematocrit (HCT) is the ratio of red blood cells to plasma and
is expressed as a percentage of the whole blood volume. The HCT
is calculated from the RBC count and the MCV as follows:

HCT = (RBC x MCV)/10

MCH
The mean corpuscular hemoglobin (MCH) is the average amount
of hemoglobin contained in the red blood cell, expressed in
picograms. The MCH is calculated from the RBC and the HGB as
follows:
MCH = (HGB/RBC) x 10

MCHC
The mean corpuscular hemoglobin concentration (MCHC) is the
ratio of the weight of hemoglobin to the volume of the average
red blood cell, expressed in percent. It is calculated from the HGB
and the HCT as follows:
MCHC = (HGB/HCT) x 100

RDW
Red cell distribution width (RDW) is a measure of the
heterogeneity of the RBC population. The CELL-DYN 3700 System
reports a relative RDW equivalent to a CV in percent. The RDW is
derived from the RBC histogram using the width of the RBC
distribution at 50% of the peak height.

RBC Flagging
For a detailed discussion of the RBC flagging messages, refer to
Operational Messages and Data Flagging within this chapter.

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RBC/PLT Analysis Chapter 3

Reticulocytes
Reticulocytes are transitional red cells between nucleated red cells
(NRBCs) and the so-called mature erythrocytes. The CELL-DYN
3700 System reports the reticulocyte percent, the Immature
Reticulocyte Fraction (IRF), and will report the reticulocyte
absolute number if the RBC value is entered.

Reticulocytes and Reticulocyte flagging are discussed in detail in


Chapter 14: Reticulocyte Package.

PLT Measurement Process


Pulses counted in the RBC/PLT dilution between 1 and 35 fL are
included in the platelet (PLT) data. If the raw PLT count is
estimated to be below a predetermined value, the instrument
automatically continues to count PLTs for an extended count
period. The results from the two count periods are then averaged.
The PLT data are plotted as a histogram. An algorithm analyzes
the histogram to eliminate interference and determine the lower
and upper thresholds for the count.

If no interference is detected, the lower and upper thresholds are


set at 2 and 30 fL respectively. If interference is detected, the
thresholds float to determine the best separation between the
interference and the PLT population. The lower threshold floats in
the 1–3 fL region and the upper threshold floats in the 15–35 fL
region. Once the thresholds have been determined, the PLT count
is derived from the data between them.

Interference in the upper threshold region is generally caused by


microcytic RBCs. Therefore, after the PLT upper threshold has
been determined, the data between it and the RBC lower
threshold are reevaluated. If the PLT upper threshold is less than
35 fL, the counts above it (but less than the RBC lower threshold)
are added to the RBC count.

If the interference in either threshold region exceeds a


predetermined limit, the PLT count is flagged accordingly. PLT
flags are discussed in Operational Messages and Data Flagging
within this chapter.

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Principles of Operation
Chapter 3 RBC/PLT Analysis

PLT Parameters

Figure 3.12: PLT Data and Histogram

All numeric and frequency size distribution data are


automatically displayed on the Data Station RUN screen in the
format selected. The size distribution data for the platelets are
displayed graphically as a histogram with the size distribution
data plotted on the X axis and the relative number of cells
normalized and plotted on the Y axis. The PLT data and histogram
are shown in the preceding figure.

PLT Count
The platelet count (PLT count) is derived from the PLT histogram
after the PLT data have been analyzed by the platelet algorithm.
The PLT count is expressed as follows:

PLT = # x 103/µL (109/L)

MPV
The mean platelet volume (MPV) is derived from the PLT
histogram after the PLT count has been determined. The MPV is
expressed in femtoliters.

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Principles of Operation
RBC/PLT Analysis Chapter 3

PCT
The plateletcrit (PCT) is the product of the PLT count and the
MPV, and it is analogous to the hematocrit. It is expressed in
percent and is calculated as follows:
PCT = (PLT x MPV)/10,000

PDW
The platelet distribution width (PDW) is a measure of the
heterogeneity of the PLT population. It is expressed as the
geometric standard deviation.
NOTE: Clinical significance has not been established for
PCT and PDW. Therefore, they are not reportable in the
U.S. They are provided for laboratory use only.

Platelet Flagging
For a detailed discussion of the PLT flagging messages, refer to
Operational Messages and Data Flagging within this chapter.

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Chapter 3 Principles of Operation

Hemoglobin Analysis

Overview
The HGB channel is used for the colorimetric determination of
hemoglobin. A 1:301 dilution of the sample is made with the
Diluent and the WIC/HGB lyse reagent in the mixing chamber of
the WIC transducer. This dilution is used for the WIC count and the
HGB measurement. Traditionally, the HGB concentration is
measured using a modified hemiglobincyanide method. However,
in an effort to create a safe, environmentally-responsible
atmosphere, the CELL-DYN 3700 System can use a cyanide-free
reagent. This reagent converts HGB to a hemiglobinhydroxylamine
complex. A filtered LED with a wavelength of 540 nm is the light
source. A photodetector measures the light that is transmitted.

Hemoglobin Measurement Process


The WIC/HGB lyse reagent lyses the diluted red blood cells and
converts the hemoglobin that is released to a stable chromagen.
After the WIC count is completed, the sample is transferred to the
hemoglobin Flow Cell where the hemoglobin concentration is
measured. The sample enters the Flow Cell from the bottom. This
allows any bubbles present to float to the surface so they will not
interfere with the reading.
The LED shines through the Flow Cell and a 540-nm narrow
bandwidth filter onto a photodetector. The hemoglobin
concentration is directly proportional to the absorbance of the
sample at 540 nm. Five separate HGB readings are made on each
sample. The lowest and highest are eliminated and the remaining
three are averaged to give the final HGB sample reading. After the
hemoglobin readings have been made, the HGB flow cell is rinsed
with detergent.
The rinse is drained and more detergent is delivered to the Flow
Cell. A zero or blank reading is then obtained on the detergent to
provide a reference to which the sample signal is compared. Five
separate blank readings are made on each sample. The lowest and
highest are eliminated and the remaining three are averaged to
give the final HGB reference reading.
The reference and sample readings are compared to determine the
HGB concentration of the sample. The HGB result is expressed in
grams of hemoglobin per deciliter of whole blood. Up to two
decimal places may be displayed for hemoglobin results less than
10 g/dL.

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Principles of Operation
Hemoglobin Analysis Chapter 3

HGB Parameters
The Hemoglobin is directly measured and is expressed in grams of
hemoglobin per deciliter of whole blood.

When the WBC is >30 K/µL, the hemogobin value is automatically


corrected for the WBC Count. The corrected hemoglobin value is
displayed on the main RUN screen.

The hemoglobin value is suppressed, with <<<< displayed for the


hemoglobin result, whenever the WBC count is greater than
250 x 103/µL (WOC) or 99.9 x 103/µL (WIC).

NOTE: Never use a hemoglobin standard designed for use


with reference cyanmethemoglobin methodology directly
on the CELL-DYN 3700 System. The CELL-DYN 3700
System uses a modified hemiglobincyanide or modified
hemiglobin-hydroxylamine method, which is not designed
to analyze these standards directly.

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Chapter 3 Principles of Operation

Operational Messages and Data Flagging

Introduction
Operational messages and data flags appear on the Data Station
RUN screen and on printed reports. They can also be transmitted
to a laboratory computer system. The CELL-DYN 3700 System
monitors instrument conditions and data criteria that may affect
the displayed results. These messages and flags are used to alert the
operator. Instructions for interpreting all flags and numeric, scatter,
and histogram data should be incorporated into the laboratory’s
procedure and used to determine the need for further action and/or
review of results. Messages are divided into the following categories:
• Instrument Fault and Status Messages
• Parameter Flagging Messages
Dispersional Data Alerts
Suspect Parameter Flags
Suspect Population Flags
Interpretive Messages
Detailed descriptions of these messages are given in this section.

NOTE: Reticulocyte Flags are described in Chapter 14:


Reticulocyte Package.

Interfering Substances
It is important to note that there are commonly occurring
interfering substances that can affect the results reported by
hematology analyzers. While the CELL-DYN 3700 has been
designed to detect and flag many of these substances, it may not
always be possible to do so. The following indicates the substances
that may interfere with each of the listed parameters.
WBC: Fragile WBCs, neutrophil aggregates, lytic-resistant RBCs,
NRBCs, PLT clumps, cryofibrinogen, cryoglobulin,
paraproteins
RBC: Elevated WBC count, increased numbers of giant PLTs,
auto-agglutination, in vitro hemolysis
HBG: Elevated WBC count, increased plasma substances
(triglycerides, bilirubin, in vivo hemolysis), lytic-resistant
RBCs.
MCV: Elevated WBC count, hyperglycemia, in vitro hemolysis,
increased numbers of giant PLTs.

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Principles of Operation
Operational Messages and Data Flagging Chapter 3

PLT: WBC fragments, in vitro hemolysis, microcytic RBCs,


cryofibrinogen, cryoglobulins, PLT clumping, increased
numbers of giant PLTs.
For additional information on interfering substances, refer to the
table provided in Appendix C.
For a detailed description of the flags that are generated, refer to
Section 3: Principles of Operation; Subsection: Operational
Messages and Data Flagging.

Instrument Fault and Status Messages


The Instrument Fault and Status Messages are discussed in detail
in Chapter 10: Troubleshooting. These messages are displayed
when the instrument detects an inappropriate condition during
specimen processing. When necessary, data are suppressed. When
any of these messages is displayed, refer to the Troubleshooting
Guide in Chapter 10: Troubleshooting for assistance. Follow the
instructions given and take the appropriate corrective action.
When the problem is corrected, rerun the specimen.

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Chapter 3 Operational Messages and Data Flagging

Parameter Flagging Messages


The following table summarizes all of the parameter flagging
messages by parameter and category.

Table 3.1: Parameter Flagging Messages

Suspect Suspect
Parameter Population Interpretive
Parameter Dispersional Data Alerts Flags Flags Messages

WBC* Result displays in yellow if WBC NWBC Leukopenia


below lower limit FWBC Leukocytosis
NRBC
Result displays in purple if RRBC
above upper limit

Result underlined on
graphics printout when
limits exceeded

Result underlined on blank


ticket when limits exceeded

Result marked with asterisk


(*) on pre-printed ticket
when results exceeded
Differential DFLT BAND Neutropenia
NEU (NLMEB) IG Neutrophilia
LYM Same as WBC BLAST Lymphopenia
MONO VARLYM Lymphocytosis
EOS Monocytosis
BASO Eosinophilia
Basophilia
RBC RBC MORPH Anemia
MCV Polycythemia
RDW Same as WBC Microcytic RBC
MCH Macrocytic RBC
MCHC Hypochromic
Hyperchromic
Anisocytosis
PLT LRI MPV Suppressed Thrombocytopenia
MPV Same as WBC URI (not displayed or Thrombocytosis
LURI printed) Microcytic PLT
PLTR Macrocytic PLT
* One of the WBC descriptors (WIC or WOC) will be displayed next to the WBC value either, when the WIC and WOC
differ by a clinically significant percentage or when the declining rate is detected and the count in the N1 (stroma)
region of the scatterplot is less than 2.9% of the total WBC. The WBC value is reportable if there are no additional
Suspect Parameter Flags present. If no descriptor or WBC Suspect Parameter Flag is present, the value selected is the
WOC.

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Principles of Operation
Operational Messages and Data Flagging Chapter 3

Dispersional Data Alerts


Dispersional Data Alerts are triggered by the numeric limits
entered into the four Patient Limit Sets (see Set Up Instructions in
Chapter 5: Operating Instructions for an explanation) or taken
from the instrument’s preset linearity limits. If results for a
parameter exceed these limits, they are flagged on the screen and on
the report. Dispersional alerts are displayed or printed as follows:

Screen display: Result below lower limit shown in yellow


Result above upper limit shown in purple

Linearity Exceeded: Result displayed as >>>>

NOTE: When the WBC result exceeds the linearity (>>>>),


the HGB result is displayed as <<<< to indicate possible
interference with the HGB due to the elevated WBC result.

Graphic Report: Results outside limits underlined

Blank Ticket: Results outside limits underlined

Preprinted Ticket: Results outside limits marked with an


asterisk (*)

Specimens with results that exceed the linearity should be diluted


with Diluent according to the laboratory’s procedure and repeated.
(Be sure to correct the results for the dilution factor used.) If
desired, diluted specimens may be run in the Auxiliary Mode. Refer
to the directions given in Chapter 5: Operating Instructions,
Subsection: Specimen Type Soft Key, Auxiliary Soft Key.

NOTE: MCV, MCH, MCHC, and MPV are unaffected by


dilution and do not require correction.

It is suggested that one Patient Limit Set be used to enter


instrument-specific laboratory action limits. If the Interpretive
Report option is enabled, the Interpretive messages, such as
leukocytosis, anemia, thrombocytopenia, etc., will be displayed
when a result falls outside the appropriate limit. A result that falls
outside a laboratory action limit can also indicate the need for the
operator to follow a laboratory protocol, such as repeating the
sample, notifying the physician or performing a smear review. In
cases where a cellular abnormality is present that alters cellular
morphology to the point that the cells do not fit the criteria used
by the instrument to generate a flag, dispersional data alerts may
be the only flag(s) that will alert the operator to a potentially
erroneous result.

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Chapter 3 Operational Messages and Data Flagging

WIC and WOC Linearity


The WIC count is linear to 99.9 K/µL. If the WIC value is selected
as the reported value and it exceeds the linearity, the WBC is
reported as overrange (>>>>).
The WOC value is linear to 250 K/µL. If the WOC value is selected
as the reported value and it exceeds the linearity, the WBC is
reported as overrange (>>>>).
NOTE: When the WBC result exceeds the linearity (>>>>),
the HGB result is displayed as <<<< to indicate possible
interference with the HGB due to the elevated WBC result.

Flagging Diagnostics Screen


The Flagging Diagnostics screen shown in the following figure is
provided for laboratory use only, to assist in the review of
abnormal samples. It is displayed by pressing the Page Down key
on the keyboard while the RUN screen or the Data Log DISPLAY
SPECIMEN screen is displayed. The screen may be printed by
pressing the [PRINT] soft key or the Print Screen key on the
keyboard. Both the [PRINT] soft key and the Print Screen key on the
keyboard will print in a horizontal (landscape) format.

Spec ID ------------ FLAGGING DIAGNOSTICS


Nov 19 1998 16:00
Ready
Operator ID BLC
Sequence # For Laboratory Use Only
Sequence # 1471
Open Sampler

G
BAND FLAG ESTIMATE R
REGION %: A
N
IG FLAG ESTIMATE L
R
REGION %:
T
Y
BLAST FLAG ESTIMATE
REGION %: MONO-POLY LOBULARITY

VAR LYM FLAG ESTIMATE


REGION %: 9 9
0 0
NRBC FLAG REGION ESTIMATE d d
PER 100 WBCS: e e
g g

10 deg 0 deg

PRINT RETURN

Figure 3.13: Flagging Diagnostics Screen

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Principles of Operation
Operational Messages and Data Flagging Chapter 3

The Specimen ID and Sequence Number for the specimen


currently displayed are indicated in the upper left-hand corner.
The information displayed in the upper right-hand corner
indicates the current operational status of the Analyzer including
the current date, time, operator ID, Sequence Number, and
Sampler Mode (Open or Closed).
The region percentage estimates for the Suspect BAND, IG, BLAST
and VAR LYM flags are displayed on the left side of the screen.
Each percentage is an estimate of the number of cells present in
the region of scatter on the 0°/10° plot where that population is
typically located. The NRBC estimate is expressed in #/100 WBC.
Consequently, this percentage information is included in the
criteria used to generate these Suspect Population Flags, which are
displayed on the RUN screen and the Data Log DISPLAY SPECIMEN
screen. The Flagging Diagnostics information is provided to
indicate the possible severity of the Suspect flag.
The graphs located on the right side of the screen are determined
by the parameter set the operator selected for the displayed
specimen. The number of the selected parameter set is indicated
on the RUN screen and the Data Log DISPLAY SPECIMEN screen. The
parameter set can be edited after the sample is processed by using
the [EDIT SPECIMEN] key on the Data Log DISPLAY SPECIMEN screen.
The Flagging Diagnostics information is provided for laboratory
use only, and it is suggested that the information be incorporated
into the laboratory's review criteria.

Introduction to WBC Flagging


The WIC/WOC algorithm evaluates the WIC and the WOC counts
to determine whether WIC is equal to or different from WOC, and
all subsequent decisions are made based on this initial
determination. When WIC is equal to WOC, subsequent decisions
follow one decision tree, and when WIC and WOC differ, the
decisions follow another decision tree. When WIC and WOC are
equal, the WOC is selected as the reported WBC. When WIC and
WOC differ, the algorithm evaluates the difference and selects the
most appropriate value for the reported WBC.
All WBC flags result from either the evaluation of the WOC
analysis (BAND, IG, BLAST, VAR LYM, NWBC, DFLT) or the
evaluation of the WIC and WOC data (WBC, FWBC, NRBC, RRBC).
This section discusses each count and how they interact to
produce the reported WBC value and generate appropriate flags. A
discussion of the cell populations responsible for some of the
flags is included, and all of the individual flags are described in
Flagging Summary within this chapter. An overview of WIC/WOC
interaction is given in WBC Analysis within this chapter.

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Chapter 3 Operational Messages and Data Flagging

WBC Descriptors
The descriptors discussed in this section are displayed on the
screen to provide additional information about the reported WBC
value. A descriptor is displayed next to the WBC value only when
the WIC and WOC differed by a clinically significant percentage
and, consequently, the appropriate WBC as indicated by the
descriptor is displayed. If no descriptor or WBC Suspect Parameter
Flag is present, the WOC is the chosen value.

WIC
There is a clinically significant difference between the WIC and
WOC values and the algorithm selected the WIC count as the most
accurate WBC. Refer to Subsection: Flagging Summary, WBC
Descriptors within this section for action to be taken when the
WIC Descriptor is displayed.

WOC
There is a clinically significant difference between the WIC and
WOC values and the algorithm selected the WOC count as the
most accurate WBC. Refer to Subsection: Flagging Summary,
WBC Descriptors within this section for action to be taken when
the WOC Descriptor is displayed.

WIC/WOC Flagging Decisions

S
I
Z
E
Dynamic
Threshold

N1
Region

COMPLEXITY
Figure 3.14: Scatterplot with Increased Stroma in the N1 Region

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Principles of Operation
Operational Messages and Data Flagging Chapter 3

WIC = WOC (WIC Is Equal to WOC)


When WIC=WOC, the WOC value is selected as the reported WBC
value. The algorithm then evaluates the area below the dynamic
WBC lower threshold on the size/complexity (0°/10°) scatterplot
to determine whether there is a significant number of particles in
the N1 region. (The N1 region is the region in the lower left corner of
the scatterplot below the dynamic threshold but above the
hardware threshold. See the preceding figure.) If the count in the
N1 region is greater than 2.9% of the total WBC, the NWBC (Non-
WBC) flag is displayed. The NWBC flag indicates the presence of a
non-WBC population of interest in the N1 region below the WBC
threshold. This population may include the following:
• Low levels of NRBCs
• Unlysed RBCs
• PLT clumps
• Giant PLTs

WIC ≠ WOC (WIC Is Not Equal to WOC)


In order to understand the function of the WIC/WOC algorithm
when WIC and WOC differ, it is necessary to evaluate the
underlying pathology responsible for the difference between the
values. Experience has shown that generally when WIC is higher
than WOC, the presence of NRBCs is suspected. When WOC is
higher than WIC, the presence of lyse-resistant RBCs is generally
suspected. When fragile WBCs are present, WIC may be higher
than WOC due to the kinetic decline in the WOC count rate
caused by the disintegration of the fragile cells in the Sheath
Reagent. The instrument automatically selects the WIC value
when a significant declining count rate is detected and the count
in the N1 (stroma) region of the scatterplot is less than 2.9% of
the total WBC. The reasoning for each of these determinations
will be discussed in the following paragraphs.

Algorithm Decision Criteria


The following factors are considered by the algorithm to evaluate
the specimen results, identify the pathology responsible for a
difference between WIC and WOC, and select the most accurate
WBC value and most appropriate flags.
• Is the WIC value greater than the WOC value?
• Is the WIC value greater than 99.9 K/µL (WIC linearity limit)?
• Is the WOC value greater than the WIC value?

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• Was the specimen run in the Resistant RBC mode?


• Is the Lymphocyte % greater than 60?
• Is there a kinetic decline in the WOC count?
• Is the count in the area (N1 region) below the dynamic WBC
threshold (0°/10° scatterplot) greater than 2.9% of the total
WBC count?
The flags that result from the instrument’s evaluation of the above
criteria are discussed in the following section. The individual
flags, including cause and corrective action, are also discussed in
Flagging Summary at the end of this chapter.

Cell Populations and Flagging


Fragile WBCs (WIC > WOC or WOC > WIC)
When fragile WBCs are present, the WIC or the WOC may be the
higher value due to the gradual destruction of the fragile cells by
both of the lysing agents. Typically, the fragile WBCs are
lymphocytes that are present in chronic lymphocytic leukemia
and are the smudge cells that appear when the blood smear is
made. These lymphocytes cause a kinetic decline in the WOC
count rate. When the declining rate is detected and the count in
the N1 (stroma) region of the scatterplot is less than 2.9% of the
total WBC, the algorithm selects the WIC as the reported value. In
this case, WIC is assumed to be the most accurate result and is
reported with the WBC Suspect Parameter Flag.
NOTE: Mechanical and chemical trauma may increase
cellular destruction. Consequently, specimens containing
fragile WBCs should not be run in the Resistant RBC cycle
because the extended lysing time may increase cellular
destruction. However, if the reported WBC exceeds the
linearity, it is appropriate to run the diluted specimen in
the Auxiliary Mode to obtain the WBC value. Always
compare the results and flags displayed in the Auxiliary
Mode to those obtained in the Patient Run Mode and
evaluate the individual flags displayed in both modes as
described in Flagging Summary within this chapter.

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Operational Messages and Data Flagging Chapter 3

NRBCs (WIC > WOC)


When the WIC count is higher than the WOC count, nucleated red
blood cells (NRBCs) are usually present. NRBCs are usually, but not
always, eliminated from the WOC count by a dynamic threshold.
All nucleated cells that are larger than the WIC threshold are
included in the WIC count. Therefore, when significant numbers of
NRBCs are present they elevate the WIC value and cause a clinically
significant difference between WIC and WOC. In this case, the
WOC count is selected and the NRBC flag is displayed. When the
NRBC flag is displayed, refer to the FLAGGING DIAGNOSTICS screen
to obtain an estimate of the NRBCs present. (For further
information about the FLAGGING DIAGNOSTICS screen, refer to
Operational Messages and Data Flagging, Parameter Flagging
Messages, Flagging Diagnostics Screen within this chapter.) The
difference between WIC and WOC is used to calculate the NRBC
region estimate provided on the FLAGGING DIAGNOSTICS screen:

NRBC Flag Region estimate = (WIC - WOC) x 100


WOC

Lyse-Resistant RBCs (WOC > WIC)


When the WOC count is higher than the WIC count, lyse-resistant
RBCs are usually present. The “hard” detergent lyse used to obtain
the WIC count generally is strong enough to lyse RBCs that may
be resistant to other lytic agents. However, the “soft” osmotic
lysing ability of the Sheath Reagent is usually insufficient to lyse
these cells in the time allotted for the WOC count. Consequently,
the unlysed RBCs are erroneously included in the WOC count
resulting in a falsely elevated value. In all cases there is usually a
significant amount of stroma (>2.9% of the total WBC count)
present in the N1 region below the WBC dynamic threshold on
the 0°/10° scatterplot.

When the stroma is >2.9% of the total WBC and WOC is higher
than WIC, the WIC count is selected and the RRBC (Resistant RBC)
flag is displayed alerting the user to run the specimen in the
Resistant RBC Mode. The WOC count time is extended in the
Resistant RBC Mode, enabling complete lysis of the lyse-resistant
RBCs in order to produce a correct WOC value.

NOTE: A higher incidence of false positive band flags may


be evident on specimens run in the Resistant RBC Mode.

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NRBC and RRBC Flags Displayed Together


The NRBC and Resistant RBC flags may be displayed together on
some results for example from neonates, since both cell types can
be present in these specimens. The NRBC flag indicates that WIC
may be incorrect and the RRBC flag indicates that WOC may be
incorrect. Consequently, the clinical picture is unclear and
therefore, the WBC flag would also be displayed indicating that
the reported WBC is suspect.
When the specimen is run in the Resistant RBC Mode, the
interference caused by the lyse-resistant RBCs is eliminated. This
results in the WIC value being higher than the WOC, which
indicates the presence of NRBCs. Consequently, the WOC value is
selected and the NRBC flag is displayed.

DFLT (NLMEB)
The DFLT flag indicates that default (preset) criteria were used to
determine the five-part differential. This is caused by the presence
of abnormal cell clusters that the instrument cannot reliably
discriminate between, or by a low number of cells in a specific
subpopulation. Descriptors in parentheses are added to the flag to
indicate which subpopulation(s) is (are) suspect, based on the
criteria used. The descriptors are N, L, M, E, and B.
(N=Neutrophils, L=Lymphocytes, M=Monocytes, E=Eosinophils,
and B=Basophils.) The following criteria can cause the DFLT flag:

1. A default (preset) value or threshold was used to determine


the five-part differential.
2. A valley was not detected within the region that usually
separates a given cell population from another cell
population.
3. There is an abnormally low number of cells in a specific
subpopulation.

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NOTES

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Flagging Summary

WBC Descriptors
A descriptor is displayed next to the WBC value to indicate that
WIC and WOC differed by a clinically significant percentage and
the appropriate WBC as indicated by the descriptor is displayed.

WIC

Cause Action
There is a clinically significant Review a stained smear and follow
difference between the WIC and your laboratory’s protocol to
WOC values, and/or a kinetic confirm the WIC result.
decline in the WOC count rate was
detected, and the count in the N1
(stroma) region of the scatterplot
is less than 2.9% of the total WBC.
The algorithm selected the WIC
count as the most accurate WBC.

WOC

Cause Action
There is a clinically significant Review a stained smear and follow
difference between the WIC and your laboratory’s protocol to
WOC values and, therefore, the confirm the WOC result.
algorithm selected the WOC count
as the most accurate WBC.

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Flagging Summary Chapter 3

Suspect Parameter Flags


Suspect Parameter Flags are generated after the instrument
evaluates the measured data for a particular parameter or group of
parameters. The result may be suspect due to interfering
substances or because the instrument is unable to measure a
particular parameter due to a sample abnormality. The name of
each flag, the location of the flag on the display, the cause of the
flag, and action to be taken are given in the following
explanations.

WBC Flags
WBC Flag — displayed next to the WBC result

Cause Action
1. A clinically significant If the NRBC and/or RRBC flags are
difference exists between the displayed with the WBC flag,
WIC and WOC values and the repeat the specimen using the
algorithm is unable to Resistant RBC cycle to eliminate
determine the most accurate interference caused by lytic-
WBC value. The algorithm resistant RBCs. If the flag persists,
selects what is estimated to be review a stained smear for the
the best count for the reported presence of NRBCs which may
WBC value and the WBC flag is affect the WIC count and verify the
displayed indicating that the LYM value. Verify the WBC value
result is suspect. by an alternate method according
to your laboratory’s protocol.

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WBC Flag — displayed next to the WBC result (Continued)

Cause Action
2. There is a kinetic decline in the
WOC count rate. A kinetic
decline generally indicates the
presence of fragile WBCs that
gradually disintegrate in the
Sheath Reagent. When a kinetic
decline is detected and the
count in the N1 (stroma)
region of the scatterplot is less
2.9% of the total WBC, then:
• WIC, which is estimated to
be the most accurate result,
is the reported WBC. (Over
range will be displayed if
the value is greater than
99.9 x 103/µL.)
• The WBC Suspect
Parameter Flag is displayed
next to the WBC result.
• The FWBC or RRBC Suspect
Population Flag may also be
displayed.
• No WBC Differential
results are displayed.
• If the WBC result is greater
than 99.9 x 103/µL., the
hemoglobin result is
suppressed and displayed as
<<<<.
• When the hemoglobin
result is displayed as <<<<,
MCH and MCHC results are
not displayed.

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Flagging Summary Chapter 3

DFLT (NLMEB) — displayed next to the BASO %

Cause Action
Default (preset) criteria were used to Examine a stained smear to verify
determine the five-part differential the differential values for the
and therefore, some of the subpopulation(s) identified by the
populations are suspect. Descriptors, descriptor(s).
in parentheses, are added to the flag
to indicate which subpopulation(s)
is (are) suspect, based on the criteria
used. The descriptors are N, L, M, E,
and B. (N=Neutrophils,
L=Lymphocytes, M=Monocytes,
E=Eosinophils, B=Basophils.) The
following criteria can cause the DFLT
flag:
1. A default (preset) value or
threshold was used to deter-
mine the five-part differential.
2. A valley was not detected within
the region that usually separates
a given cell population from an-
other cell population.
3. There is an abnormally low
number of cells in a specific
subpopulation.

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PLT Flags

LRI (Lower Region Interference) — displayed next to the MPV result

Cause Action
Interference in the lower Check the background count. If it
threshold region (1–3 fL) is greater exceeds the limits, troubleshoot
than a predetermined limit. This is accordingly. If it is within limits,
generally non-biologic repeat the specimen. If the flag
interference. The flag may be persists, review a stained smear to
caused by: determine the cause of the
interference and verify the PLT
Debris (dirty aperture)
count.
Contaminated reagent
Electronic noise
Microbubbles

URI (Upper Region Interference) — displayed next to the MPV result

Cause Action
Interference in the upper Review the MCV and the PLT
threshold region (15–35 fL) is histogram. If the MCV is low and/
greater than a predetermined or the histogram indicates an
limit. This is generally biologic overlap (poor separation at the
interference. The flag may be upper discriminator) in the RBC
caused by: and PLT populations, review a
stained smear to determine the
Microcytic RBCs
cause and verify the PLT count.
Schistocytes
Giant Platelets
Sickle Cells
Platelet Clumps
NOTE: A “bumpy” platelet histogram may indicate the presence
of platelet clumps.

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Flagging Summary Chapter 3

LURI (Lower and Upper Region Interference) — displayed next to the


MPV result

Cause Action
Interference is present in both the Follow the guidelines given above
upper and lower regions of the PLT for the LRI and URI flags.
histogram.

PLTR (Platelet Recount) – displayed next to the platelet count

Cause Action
The PLT count was <120 K/µL and, Repeat the specimen. If the flag is
therefore, a platelet recount was no longer displayed and there are
performed. The difference no other data invalidating flags,
between the count and recount the PLT count is reportable. If the
values exceeds expected limits. flag persists, review a stained
smear and verify the PLT count

Suspect Population Flags


These flags are generated when the instrument’s evaluation of the
measured data for a particular parameter or group of parameters
indicate the possible presence of an abnormal subpopulation. A
stained smear should be reviewed whenever a suspect population
flag is present. Therefore, instructions for interpreting these flags
should be incorporated into the laboratory’s review criteria for
abnormal samples.

NOTE: The word SUSPECT will be displayed and printed


above any displayed WBC Suspect Population Flags.

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WBC Flags
BAND — displayed next to the NEU %

Cause Action
1. The count in the region of scatter Review a stained smear for the
(on the 0°/10° plot) where presence of bands and follow your
bands are typically located is laboratory’s review criteria. When
>12.5% of the total WBC count. bands are present, they are included
in the total neutrophil count.
2. The ratio of suspected bands to
mature neutrophils is >50%.
3. The CV of the neutrophil cluster
on the 0° axis exceeds expected
criteria.

IG (Immature Granulocyte) — displayed next to the NEU %

Cause Action
The count in the region of scatter Review a stained smear for the
(on the 0°/10° plot) where presence of immature granulocytes
immature granulocytes are and follow your laboratory’s review
typically located is >3% of the total criteria. When IGs are present,
WBC count. they are included in the total
neutrophil count.

BLAST — displayed next to the LYM %

Causes Action
The count in the region of scatter Review a stained smear for the
(on the 90°/0° plot) where blasts presence of blasts and follow your
are typically located is >1% of the laboratory’s review criteria. When
total WBC count. blasts are present, they are typically
included in the monocyte count.

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Flagging Summary Chapter 3

VAR LYM — displayed next to the LYM %

Cause Action
1. The count in the region of scatter Review a stained smear for the
on the size/complexity (0°/10°) presence of variant lymphocytes
scatterplot where variant and/or smudge cells and follow
Lymphs are typically located is your laboratory's review criteria.
>10% of the total WBC count. When variant lymphocytes or
smudge cells are present, they are
2. The absolute lymphocyte or the
included in the lymphocyte count.
absolute mononuclear (including
basophils) count exceeds expected
criteria and the ratio of
lymphocytes to monocytes
exceeds a predetermined limit.
3. The ratio of neutrophils to
lymphocytes falls below
expected criteria.
4. The WIC/WOC comparison
indicates the suspected presence
of variant lymphocytes.

NOTE: This flag may be displayed singly or in


combination with the blast flag. If the flag is displayed
with the blast flag, it is displayed as VLYM/BLAST.

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Chapter 3 Flagging Summary

NWBC (Non–White Blood Cell) — displayed next to the Mono % result

Causes Action
A non-WBC population is present Review a stained smear and follow
in the N1 region below the dynamic your laboratory's review criteria to
WBC threshold on the size/ determine the cause of the elevated
complexity (0°/10°) scatterplot. count in the N1 region. If NRBCs
The count in the N1 region is are present and correction of the
greater than 2.9% of the total WBC. WBC is required, correct the WIC
The WIC value is equal to the WOC value and use the resultant number
value and WOC is the reported to confirm the WOC. If no other
WBC. The cell types that may be Suspect Parameter flags are
present in the N1 region are: present, the corrected WIC (or
confirmed WOC) value is
Low levels of NRBCs
reportable. If something other
Unlysed RBCs than NRBCs caused the elevated
PLT clumps count in the N1 region, follow
your laboratory’s protocol for
Giant PLTs reporting the WBC result.

FWBC (Fragile White Blood Cells) — displayed next to the Mono % result

Causes Action
The presence of fragile WBCs is Review a stained smear and follow
suspected. A kinetic decline in the your laboratory's review criteria to
WOC count rate was detected and confirm the LYM values and the
the count in the N1 (stroma) reported WBC value. If no suspect
region of the scatterplot is less than parameter flags are present, the
2.9% of the total WBC. The confirmed WBC and Differential
algorithm selects WIC, estimated may be reported.
to be the best count for the
reported WBC value, and displays
the WBC flag to indicate that the
result is suspect.

NOTE: Mechanical and chemical trauma may increase


cellular destruction. Consequently, specimens containing
fragile WBCs should not be run in the Resistant RBC cycle
because the extended lysing time will increase cellular
destruction. However, if the reported WBC value exceeds
the linearity, it is appropriate to run the diluted specimen
in the Auxiliary Mode to obtain the WBC value. Always
compare the results and flags displayed in the Auxiliary
Mode to those obtained in the Patient Run Mode, and
evaluate the individual flags displayed in both modes as
described in this section.

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Flagging Summary Chapter 3

NRBC (Nucleated Red Blood Cells) — displayed next to the MONO %

Causes Action
The presence of NRBCs is suspected. Review a stained smear for the
The WIC count is higher than the presence of NRBCs and follow your
WOC and the WOC is the reported laboratory's review criteria. If
value. The count in the N1 region, NRBCs are present they should be
below the dynamic WBC threshold quantified according to your
on the size/complexity (0°/10°) laboratory's procedure. If
scatterplot, is greater than 2.9% of correction of the WBC is required,
the total WBC. Cell types that may correct the WIC value and use the
be present in the N1 region: resultant number to confirm the
WOC result. If no other Suspect
NRBCs
Parameter Flags are present, the
PLT clumps corrected WIC (or confirmed
Giant PLTs. WOC) value is reportable. If the
WBC flag is displayed with the
NRBC flag, repeat the specimen
using the Resistant RBC cycle to
eliminate possible interference
from any lytic-resistant RBCs that
may be present with the NRBCs.

RRBC (Resistant Red Blood Cells) — displayed next to the Mono % result

Causes Action
The presence of lyse-resistant RBCs is Repeat the specimen using the
suspected. The WOC count is higher Resistant RBC cycle to eliminate
than the WIC count and there is a interference from any lytic-resistant
significant amount of stroma RBCs that may be present. (The
present (>2.9% of the total WBC) in Resistant RBC cycle reduces the
the N1 region, below the dynamic number of flags generated. However,
WBC threshold on the size/ an increase in false positive band
complexity (0°/10°) scatterplot. flags may be evident.) The
appropriate WBC value is selected
as indicated by the descriptor. If the
WBC flag is displayed, review a
stained smear to determine the
cause of the interference. Verify the
WBC value by an alternate method
according to your laboratory’s
protocol.

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RBC Flag

RBC MORPH — displayed next to the HCT result

Cause Action
One or more of the following Review a stained smear for abnormal
parameters exceeds expected RBC or PLT morphology and follow
limits: your laboratory’s review criteria.

MCV <80 fL or >100 fL


MCH <25 pg or >34 pg
MCHC <29 g/dL or >37 g/dL
RDW >18.5%

PLT Flag

No MPV result displayed (data suppressed)

Cause Action
The PLT histogram did not meet Review a stained smear for abnormal
expected criteria (non-log PLT morphology or the presence of
normal distribution). PLT aggregates and follow your
laboratory’s review criteria. Verify
the PLT count.

Flagging Diagnostics Screen


The FLAGGING DIAGNOSTICS screen is provided for laboratory use
only to assist in the review of abnormal samples. It is displayed by
pressing the Page Down key on the keyboard while the RUN screen or
the Data Log DISPLAY SPECIMEN screen is displayed. For additional
information, refer to the discussion in Parameter Flagging Messages,
Flagging Diagnostics Screen earlier in this chapter.

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Flagging Summary Chapter 3

Interpretive Messages
Interpretive messages appear only on the graphics report and are
generated when the numeric limits entered in the Patient Limit
Sets are exceeded. (See Set Up Instructions in Chapter 5:
Operating Instructions for an explanation). These messages are
printed only when the Interpretive Report option is selected on
the CUSTOMIZE REPORT Screen. The Interpretive messages are
summarized below.

WBC Messages

Message Cause
Leukopenia Result falls below the lower limit for WBC.
Leukocytosis Result exceeds the upper limit for WBC.
Neutropenia Result falls below the lower limit for Neutrophil
absolute number.
Neutrophilia Result exceeds the upper limit for Neutrophil
absolute number.
Lymphopenia Result falls below the lower limit for Lympho-
cyte absolute number.
Lymphocytosis Result exceeds the upper limit for Lymphocyte
absolute number.
Monocytosis Result exceeds the upper limit for Monocyte
absolute number.
Eosinophilia Result exceeds the upper limit for Eosinophil
absolute number.
Basophilia Result exceeds the upper limit for Basophil
absolute number.

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RBC Messages

Message Cause
Anemia Result falls below the lower limit for RBCs.
Polycythemia Result exceeds the upper limit for RBCs.
Microcytic RBC Result falls below the lower limit for MCV.
Macrocytic RBC Result exceeds the upper limit for MCV.
Hypochromic Result falls below the lower limit for MCHC.
Hyperchromic Result exceeds the upper limit for MCHC.
Anisocytosis Result exceeds the upper limit for RDW.

PLT Messages

Message Cause
Thrombocytopenia Result falls below the lower limit for PLTs.
Thrombocytosis Result exceeds the upper limit for PLTs.
Microcytic PLT Result falls below the lower limit for MPV.
Macrocytic PLT Result exceeds the upper limit for MPV.

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NOTES

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Chapter 3 Principles of Operation

References

1. International Committee For Standardization in


Haematology (ICSH). The Assignment of Values to Fresh
Blood Used for Calibrating Automated Cell Counters. Clinical
and Laboratory Hematology 1988; 10:203-212.
2. American Society of Clinical Pathologists (ASCP). Clinical
Applications of Flow Cytometry. ASCP National Meeting.
Spring 1990.
3. Shapiro Howard. Practical Flow Cytometry. New York: LISS.
1985.
4. Clinical and Laboratory Standards Institute/NCCLS. Methods
for Reticulocyte Counting (Automated Blood Cell Counters, Flow
Cytometry, and Supravital Dyes); Approved Guideline – Second
Edition. CLSI/NCCLS document H44-A2 (ISBN 1-56238-527-
5) 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898,
2004.

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References Chapter 3

NOTES

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Chapter 4 System Specifications
System Specification

Overview

This chapter includes physical, power, and operational


specifications for both the CELL-DYN® 3700SL System and the
CELL-DYN 3700CS System. It also includes bar code specifications
for the CELL-DYN 3700SL System. In addition, measurement
specifications, performance specifications, and performance
characteristics are included for both systems.

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System Specifications
Overview Chapter 4

NOTES

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System Specifications
Chapter 4 CELL-DYN 3700SL System Specifications

CELL-DYN 3700SL System Specifications

Physical Specifications
Table 4.1: Dimensions
Analyzer with Display Graphics
Sample Loader CPU Monitor Ticket Printer Printer
Height 27" (68 cm) 6.4” (16.3 cm) 15” (38.1 cm) 6" (15 cm) 13" (33 cm)
Width 30" (76 cm) 16.9” (42.9 cm) 14” (35.5 cm) 16.5" (41 cm) 19" (48 cm)
Depth 31" (79 cm) 17.3” (43.9 cm) 16” (40.6 cm) 14.5" (39 cm) 24" (61 cm)
Weight 288 lb (131kg) 32 lb (14.5 Kg) 30 lb (13.6 Kg) 16.5 lb (7.5 kg) 14.3 lb (6.5 kg)

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System Specifications
CELL-DYN 3700SL System Specifications Chapter 4

Power Specifications
Table 4.2: Power Specifications
Analyzer Input Requirements
Setting Range Frequency
100 90–110 VAC 50/60 Hz
120 110–130 VAC 50/60 Hz
220 200–240 VAC 50/60 Hz
240 220–260 VAC 50/60 Hz

Data Station Input Requirements


Setting Range Frequency
120 90–130 VAC 50/60 Hz
240 180–260 VAC 50/60 Hz

Printer Input Requirements


(Graphics)
Setting Frequency
120 VAC 50/60 Hz
240 VAC 50/60 Hz

Printer Input Requirements


(Ticket)
Setting Frequency
120 VAC 50/60 Hz

Sample Loader Input Requirements


Setting Range Frequency
100 90–110 VAC 50 Hz
100 90–110 VAC 60 Hz
115 105–125 VAC 60 Hz
215 195–235 VAC 50 Hz
230 210–250 VAC 50 Hz

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System Specifications
Chapter 4 CELL-DYN 3700SL System Specifications

Consumption
Analyzer: 900 watts
Data Station: 300 watts
Graphics Printer: 110 watts
Ticket Printer: 145 watts
Sample Loader: 50 watts
1550 watts maximum (5200 BTU per hour)

Transport and Storage Specifications


There are no specific environmental conditions for transport or
storage.

CELL-DYN® 3700 System Operator’s Manual 4-5


9140320D — June 2003
System Specifications
CELL-DYN 3700SL System Specifications Chapter 4

Operational Specifications
Operating Environment
Indoor Use
Temperature Patient Samples:
Room Temperature (15–30°C)

Monocyte values exhibit a change at


lower and higher temperatures. A 1.5%
decrease is seen in the total monocyte
percent at lower temperatures (<18°C).
A 6% increase will be seen at higher
temperatures (>32°C).

Background values for RBC and PLT


may exhibit an increase at lower
environmental temperatures (<18°C).

Instrument: 15–30°C

Relative Humidity 10% to 85%, RHNC

Complete Cycle Times


Auto-Startup (from Standby) Approximately 3.5 minutes
Auto-Startup (from power OFF) Approximately 5 minutes*
Run, Open Mode 37 seconds (READY to READY)
Run, Sample Loader Approximately 37 seconds
Shutdown (to Standby) 4.5 minutes
* The laser requires a 15-minute warm-up time. If the power has
been OFF longer than 5 minutes, wait 10 minutes after the
Auto-Startup Cycle is complete before processing samples.

Approximate Aspiration Volumes (Whole Blood)


Open Mode 130 µL (Auxiliary Specimen Type 300 µL)
Sample Loader 355 µL

Batch Size
1–100 tubes per batch

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System Specifications
Chapter 4 CELL-DYN 3700SL System Specifications

Throughput
Maximum throughput = 90 samples/hour

NOTE: Maximum throughput is achieved with normal


samples that do not generate any instrument operational
messages.

Collection Tube and Sample Volume


13 mm diameter x 75 mm high with a HEMOGARDTM closure

• Minimum sample volume = 1 mL


• Maximum sample volume = 3 mL
NOTE: The sample volume in the tube must be within
the specified limits for adequate mixing and sampling.

Bar Code Specifications


Bar Code Format
The following formats, with or without check digits, are
acceptable:
• Code 39
• Interleave 2 of 5
• Codabar
• Code 128

Bar Code Label Specifications


Bar code labels must meet the following specifications:

• Printed on good quality label stock


• 0.25-inch minimum quiet zone on each end
• 0.01-inch (10 mils) minimum narrow bar width
• 2:1 to 3:1 wide to narrow bar ratio
• 0.5-inch minimum bar length
• 2-inch maximum label length
• 1.25-inch maximum label width
• Maximum possible contrast between bars and background label
NOTE: Refer to Appendix A: Bar Codes for complete
information on bar code label formats, check digits, and
specifications.

CELL-DYN® 3700 System Operator’s Manual 4-7


9140320D — June 2003
System Specifications
CELL-DYN 3700SL System Specifications Chapter 4

NOTES

4-8 CELL-DYN® 3700 System Operator’s Manual


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System Specifications
Chapter 4 CELL-DYN 3700CS System Specifications

CELL-DYN 3700CS System Specifications

Physical Specifications
Table 4.3: Dimensions
Display Graphics
Analyzer CPU Monitor Ticket Printer Printer
Height 24" (61 cm) 6.4” (16.3 cm) 15” (38.1 cm) 6" (15 cm) 13" (33 cm)
Width 30" (76 cm) 16.9” (42.9 cm) 14” (35.5 cm) 16.5" (41 cm) 19" (48 cm)
Depth 22" (56 cm) 17.3” (43.9 cm) 16” (40.6 cm) 14.5" (39 cm) 24" (61 cm)
Weight 190 lb (86 kg) 32 lb (14.5 Kg) 30 lb (13.6 Kg) 16.5 lb (7.5 kg) 14.3 lb (6.5 kg)

CELL-DYN® 3700 System Operator’s Manual 4-9


9140320C — November 2000
System Specifications
CELL-DYN 3700CS System Specifications Chapter 4

Power Specifications
Table 4.4: Power Specifications
Analyzer Input Requirements
Setting Range Frequency
100 90–110 VAC 50/60 Hz
120 110–130 VAC 50/60 Hz
220 200–240 VAC 50/60 Hz
240 220–260 VAC 50/60 Hz

Data Station Input Requirements


Setting Range Frequency
120 90–130 VAC 50/60 Hz
240 180–260 VAC 50/60 Hz

Printer Input Requirements


(Graphics)
Setting Frequency
120 VAC 50/60 Hz
240 VAC 50/60 Hz

Printer Input Requirements


(Ticket)
Setting Frequency
120 VAC 50/60 Hz

Consumption
Analyzer: 900 watts
Data Station: 300 watts
Graphics Printer: 110 watts
Ticket Printer: 145 watts
1550 watts maximum (5200 BTU per hour)

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System Specifications
Chapter 4 CELL-DYN 3700CS System Specifications

Operational Specifications
Operating Environment
Temperature Patient Samples:
Room Temperature (15–30°C)

Monocyte values exhibit a change at


lower and higher temperatures. A 1.5%
decrease is seen in the total monocyte
percent at lower temperatures (<18°C).
A 6% increase will be seen at higher
temperatures (>32°C).

Instrument: 15–30°C

Background values for RBC and PLT


may exhibit an increase at lower
environmental temperatures (<18°C).

Relative Humidity 10% to 85%, RHNC

Complete Cycle Times


Auto-Startup (from Standby) Approximately 3.5 minutes
Auto-Startup (from power OFF) Approximately 5 minutes*
Run, Open Mode 37 seconds (READY to READY)
Run, Closed Mode Approximately 40 seconds
Shutdown (to Standby) 4.5 minutes
* The laser requires a 15 minute warm up time. If the power has
been OFF longer than 5 minutes, wait 10 minutes after the
Auto-Startup Cycle is complete before processing samples.

Approximate Aspiration Volumes (Whole Blood)


Open Mode 130 µL (Auxiliary Specimen Type 300 µL)
Closed Mode 240 µL

CELL-DYN® 3700 System Operator’s Manual 4-11


9140320E — September 2004
System Specifications
CELL-DYN 3700CS System Specifications Chapter 4

NOTES

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System Specifications
Chapter 4 Combined Specifications for the SL and CS Systems

Combined Specifications for the SL and CS Systems

Measurement Specifications
Measurement Channels
• Laser Optics for WOC (WBC Optical Count) and WBC
Differential
• Two impedance channels, one for WIC (WBC Impedance
Count) and one for both RBC and PLT
• Hemoglobin Absorbance

WBC and Differential


WIC: Method Electrical Impedance

Aperture Size 100 µm (diameter) x 77 µm (length)

Dilution 1:301 of blood in Diluent and


WIC/HGB Lyse

Data Collection 256 channels, each channel = 0.5 fL

WOC: Method Laser light scatter

Light Source Vertically polarized 5–10 mW helium-


neon laser

Wavelength 632.8 nm

Dilution 1:51 of blood in Sheath Reagent

Data Collection Four angles measured:


0°, 10°, 90°, and 90° depolarized.
Data collected in 256 channels for
each angle of light scatter.

CELL-DYN® 3700 System Operator’s Manual 4-13


9140320C — November 2000
System Specifications
Combined Specifications for the SL and CS Systems Chapter 4

RBCs and PLTs


Method Electrical Impedance

Aperture Size 60 µm (diameter) x 72 µm (length)

Dilution 1:9,760 of blood in Diluent

Data Collection 256 channels for RBCs,


each RBC channel = 1 fL

256 channels for PLTs,


each PLT channel = 0.137 fL

HGB
Method Modified hemiglobincyanide or modified
hemiglobinhydroxylamine

Light Source Light Emitting Diode, wavelength: 555 nm

Filter Interference Filter


Center wavelength: 540 nm
Bandwidth (at 1/2 peak): 22 nm

Dilution 1:301 of blood in Diluent and WIC/HGB


Lyse or WIC/HGB Cyanide-Free Lyse

Data Collection Average of 5 absorbance readings for the


detergent blank, average of 5 absorbance
readings for the sample dilution

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System Specifications
Chapter 4 Combined Specifications for the SL and CS Systems

Performance Specifications
Background Counts (Acceptable Up to Limits Listed)
WIC <0.30
WOC <0.30
RBC <0.03
HGB <0.20
PLT <10.0
RETIC <100 counts/count cycle
NOTE: Background counts must be within acceptable
limits before running controls and patient specimens.

Precision
Samples that are used to verify precision specifications should
have results that fall within the laboratory's normal range. These
samples should not display any of the following WBC descriptors
or Suspect Parameter Flags:

WBC
WIC
WOC
RBC MORPH
LRI
URI
LURI
PLTR
Fragile RBCs
ERL
ENC
The stated precision values are applicable to the Open, Closed
Sampler, and Sample Loader Modes.

CELL-DYN® 3700 System Operator’s Manual 4-15


9140320F — April 2007
System Specifications
Combined Specifications for the SL and CS Systems Chapter 4

Hemogram Parameters
Precision specifications for the hemogram parameters are given
as a 95% confidence limit for the Coefficient of Variation (CV) of
at least 31 determinations of the same sample.

Table 4.5: Precision of the Hemogram and Reticulocyte


Parameters (N = 31)
Parameter CV
WBC (WOC) <2.5%
WBC (WIC) <2.8%
RBC <1.5%
HGB <1.2%
MCV <1.0%
RDW <5.0%
PLT <5.0%
MPV <6.1%
RETIC % <15.0 %

NOTE: If the reported WBC is not accompanied by a WBC


descriptor (WIC or WOC), the WBC (WOC) precision
specification applies because WOC is the primary reported
value when WIC and WOC values are equal.

WBC Differential Parameters


Precision specifications for the WBC Differential parameters are
given as a 95% confidence limit for the difference of individual
results in N = 31 determinations of the same sample from the
mean of the determinations. The mean of sample’s WBC
subpopulations should fall within the ranges listed below.

Table 4.6: Precision of the WBC Differential Parameters


Difference from
Cell Type Range Mean of N = 31
Neutrophil % 45–70% ± 2.1
Lymphocyte % 20– 40% ± 2.6
Monocyte % 3.5–11.5% ± 2.4
Eosinophil % 0.5– 8.0% ± 1.0
Basophil % 0.5–2.0% ± 1.0

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System Specifications
Chapter 4 Combined Specifications for the SL and CS Systems

Linearity
Linearity specifications were determined by analyzing dilutions
of a commercially available linearity control material that
contains no interfering substances. Specifications are determined
by taking multiple measurements for each dilution to minimize
the effect of imprecision. The stated limits (refer to the following
table) are determined by regression through the origin (0,0),
throughout the linear reportable range.
Reticulocyte linearity was determined by running six levels of
reticulocyte control material prepared by mixing varying
concentrations of two stock preparations. The general method
described in CLSI/NCCLS Document EP6-A, Evaluation of the
Linearity of Quantitative Analytical Methods, was used.1
Specifically, six concentration levels were run in quadruplicate,
and the method of least squares regression was used for analysis
of the reticulocyte percentage result.
NOTE: Results that exceed the linear range must be
confirmed by diluting the specimen until the result falls
within the appropriate linear range and then correcting
that result for the dilution in order to obtain a reportable
result.

Table 4.7: Linearity Specifications


Acceptable Limits
(whichever is
Parameter Linear Range greater)
0–99.9 K/µL +0.4 or 3.0%
WIC
WBC { WOC 0–250 K/µL +0.4 or 4.0%
RBC 0–8 M/µL +0.1 or 2.5%
HGB 0–24 g/dL +0.3 or 2.0%
MCV 50–200 fL +3.0 or 3.0%
PLT 0–2000 K/µL +10.0 or 7%
MPV 5–18 fL +1.0 or 6.0%
RETIC % 0–30 % +1.1 or 7.0%

CELL-DYN® 3700 System Operator’s Manual 4-17


9140320F — April 2007
System Specifications
Combined Specifications for the SL and CS Systems Chapter 4

Accuracy
The CELL-DYN 3700 System can be calibrated to agree with
reference values within the allowable calibration ranges. Both
modes of operation, Open and Closed (CS and SL), may be
calibrated. Thus, it is possible to compensate for differences
between modes due to differing aspiration pathways. When each
mode is properly calibrated according to the directions given in
this manual, bias between the modes is clinically insignificant.

Accuracy specifications are determined by correlation to


reference values obtained from comparison analyzers or analysis
by reference methodology. Samples that are used for correlation
studies should not display any Suspect Parameter Flags.

Hemogram Parameters

Table 4.8: Accuracy of Hemogram Parameters


Parameter Correlation Coefficient
WBC >0.99
RBC >0.98
HGB >0.98
MCV >0.98
PLT >0.98
MPV >0.92
RETIC % >0.90

Due to differences in methodology, the bias results from clinical


studies showed that the CELL-DYN 3700 IRF does not have the
same sensitivity as a fluorescent method, such as that used on the
CELL-DYN 4000 System. This is especially true at low and low-
normal threshold levels.

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System Specifications
Chapter 4 Combined Specifications for the SL and CS Systems

WBC Differential Parameters

Table 4.9: Accuracy of WBC Differential Parameters


Parameter Correlation Coefficient
Neutrophil # and % >0.95
Lymphocyte # and % >0.94
Monocyte # and % >0.86
Eosinophil # and % >0.84
Basophil # and % >0.73

Carryover
Carryover is determined by running samples with high
concentrations of WBCs, RBCs, HGB, PLTs and Retics. Each
sample is run in triplicate followed by three background cycles.

Reticulocyte carryover was determined by running specimens


with high reticulocyte or RBC counts. Each specimen was run in
triplicate followed by three background cycles. Since reticulocyte
background results are given as count/count cycle, the specimen
value used in the calculation is the List Mode WOC value which
is displayed on the RETICULOCYTE RAW DATA SUMMARY screen.
This screen is accessed from the RETICULOCYTE DIAGNOSTICS
screen.

The percent carryover is calculated using the following formula:

Background1 – Background3
% Carryover = x 100
Sample3 – Background3
The Absolute Carryover is calculated as follows:
Absolute Carryover = |Background1 - Background3|

Table 4.10: Carryover for WBC, RBC, HGB, PLT and Retics
WBC RBC HGB PLT RETIC %
Level 90K/µL 7.5M/µL 22.5g/dl 1000 30,000
K/µL list mode
counts
Carryover <1.0% or <1.0% or <1.0% or <1.0% or <0.5%
(in % or <0.1 K/µL <0.03 M/µL <0.1 g/dL <10 K/µL
Absolute)

CELL-DYN® 3700 System Operator’s Manual 4-19


9140320E — September 2004
System Specifications
Combined Specifications for the SL and CS Systems Chapter 4

Performance Characteristics
Typical Precision
The pooled precision values (CVs) for the hemogram parameters
are based on the analysis of data from replicate runs of N=31. The data
were obtained from several CELL-DYN 3700 Systems over a period
of weeks and derived using samples with results in the normal
range. These precision values represent the typical performance
that can be expected from instruments that are maintained
properly, are operating in acceptable environmental conditions,
and are using only recommended reagents and supplies.

Table 4.11: Typical Precision for Hemogram Parameters


Parameter Typical CV
WBC 1.9%
RBC 1.0%
HGB 0.7%
MCV 0.8%
RDW 3.2%
PLT 3.1%
MPV 3.6%

Sensitivity and Specificity of WBC Differential Flags


The sensitivity and specificity of the WBC Differential parameters
were evaluated using the procedures outlined in CLSI/NCCLS
Document H20-A, Reference Leukocyte Differential Count
(Proportional) and Evaluation of Instrumental Methods as a guideline.2
The statistics were determined by comparing the CELL-DYN 3700
System results with a manual, 400 cell microscopic differential.
The following tables show the Reference Ranges used for the
Normal/Abnormal Determinations. The first table outlines the
ranges used for distributional sensitivity, and the second table
outlines the ranges used for morphologic sensitivity.

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9140320F — April 2007
System Specifications
Chapter 4 Combined Specifications for the SL and CS Systems

Table 4.12: Reference Range for Distributional Flagging


Parameter Reference Range
Neutrophil % 46.5%–88.7%
Lymphocyte % 12.0%–44.0%
Monocyte % 0–11.2%
Eosinophil % 0–9.5%
Basophil % 0–2.5%

Table 4.13: Reference Range for Morphologic Flagging


Parameter Reference Range
Variant Lymphocytes 0–3%
Bands 0–12%
Immature Granulocytes* 0–1%
Blasts 0–1%
NRBCs 0–1/100 WBCs
* Immature granulocytes include metamyelocytes, myelocytes,
and promyelocytes.

CELL-DYN® 3700 System Operator’s Manual 4-21


9140320C — November 2000
System Specifications
Combined Specifications for the SL and CS Systems Chapter 4

Abnormalities Evaluated
Table 4.16 lists the abnormalities and the number of cases of each
abnormality that were evaluated during the testing period.

Table 4.14: Abnormalities Evaluated


Abnormality Number of Cases
Granulocytosis 40
Granulocytopenia 27
Lymphocytosis 21
Lymphocytopenia 106
Monocytosis 31
Eosinophilia 4
Basophilia 4
Bands >12% 28
Metamyelocytes >1% 32
Myelocytes >1% 13
Promyelocytes >1% 10
Blasts >1% 12
Variant Lymphocytes >3% 22
NRBCs >1/100 WBCs 5

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System Specifications
Chapter 4 Combined Specifications for the SL and CS Systems

Truth Table
The Truth Table showing the sensitivity and specificity and the
analysis of the false negative results is presented in this section.
The data are based on the evaluation of a total of 374 cases, many
of which had multiple abnormalities. Arbitration using the 95%
confidence envelope at the upper limit of the range was applied
to the manual differential results.
In the following table:
TP = True Positive
TN = True Negative
FP = False Positive
FN = False Negative

Table 4.15: Flagging Analysis Truth Table


CELL-DYN 3700 CELL-DYN 3700 CELL-DYN 3700
Normal Morphological Distributional
Positive Positive Total
Reference Normal 165 TN 35 FP 26 FP 226
Reference 2 FN 46 TP 9 TP 57
Morphological Positive
Reference 1 FN 38 TP 52 TP 91
Distributional Positive
Total 168 119 87 374
Agreement = 82.9%
False Positives = 27.0%
False Negatives = 2.0%
NOTE: The false positive and false negative ratios shown
above express the results as a percentage of the total true
positive and total true negative results, respectively, in
accordance with CLSI/NCCLS Document H20-A.2 The
previous version of this manual expressed the results as a
percentage of the total specimens evaluated.

Table 4.16: Analysis of False Negative Results


Manual Differential CELL-DYN 3700 Differential
Morphological False Negative 2% Metamyelocytes No Flag generated
4% Metamyelocytes No Flag generated
Distributional False Negative 6.3% Lymphocytes 12.0% Lymphocytes

CELL-DYN® 3700 System Operator’s Manual 4-23


9140320F — April 2007
System Specifications
Combined Specifications for the SL and CS Systems Chapter 4

NOTES

4-24 CELL-DYN® 3700 System Operator’s Manual


9140320C — November 2000
System Specifications
Chapter 4 References

References

1. Clinical and Laboratory Standards Institute/NCCLS.


Evaluation of the Linearity of Quantitative Measurement
Procedures: A Statistical Approach; Approved Guideline. CLSI/
NCCLS document EP6-A (ISBN 1-56238-498-8) 940 West
Valley Road, Suite 1400, Wayne, PA 19087-1898, 2003.
2. Clinical and Laboratory Standards Institute. Reference
Leukocyte Differential Count (Proportional) and Evaluation of
Instrumental Methods; Approved Standard. CLSI/NCCLS
document H20-A (ISBN 1-56238-131-8) NCCLS, 940 West
Valley Road, Suite 1400, Wayne, PA 19087-1898, 1992.

CELL-DYN® 3700 System Operator’s Manual 4-25


9140320F — April 2007
System Specifications
References Chapter 4

NOTES

4-26 CELL-DYN® 3700 System Operator’s Manual


9140320C — November 2000
Chapter 5 Operating Instructions
Operating Instructions

Overview

This chapter discusses the operation of the CELL-DYN® 3700


System. It is divided into four sections. The first section, the
Overview, contains (1) instructions for an Instrument Logbook, (2)
a Data Station Program Overview, and (3) a Menu Flowchart
showing the different screens that are available on the Data
Station.
The other three sections in this chapter are identified by subtabs:
Set Up Instructions, Routine Operation, and Using the Data Log.
These three sections describe three of the major menus used in
operating the instrument: the SET UP MENU, the RUN menu, and
the DATA LOG menu.
The other major menus are described in other chapters. The
QUALITY CONTROL menu is described in Chapter 7: Quality
Control. The CALIBRATION menu is described in Chapter 6:
Calibration. The DIAGNOSTICS menu is described in Chapter 10:
Troubleshooting. And the SPECIAL PROTOCOLS menu is described
in Chapter 9: Maintenance.

Instrument Logbook
Create a logbook for the instrument. This logbook should contain
all necessary calibration documentation and other information
that is pertinent to your instrument. Suggested sections that you
may wish to include in the logbook are:
Installation documentation
Your laboratory’s operating procedure
Quality control
Calibration
Maintenance
Reagent lot number changes
Troubleshooting and problem resolution
Printed fault reports
Service calls and problem resolution/service performed
Software upgrades
This logbook should be stored near the instrument and be
accessible to all operators and Abbott Service Personnel.

CELL-DYN® 3700 System Operator’s Manual 5-1


9140320C — November 2000
Operating Instructions
Overview Chapter 5

Data Station Program Overview

Screen

Soft Keys

Figure 5.1: Data Station

The Data Station menus are presented as key labels displayed


across the bottom of the screen. Each menu is accessed by
pressing the soft key located directly below the label. (From left to
right, these soft keys correspond to keys F1– F8 on the standard
computer keyboard.)

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Operating Instructions
Chapter 5 Overview

Main Menu Screen

Version X.XX CD 3700SL MAIN MENU Dec 05 1998 15:50


Ready Operator ID sh
Sequence # 0067

SET UP RUN DATA LOG RETIC QUALITY CALIBRA- DIAG- SPECIAL


DATA LOG CONTROL TION NOSTICS PROTOCOLS

Figure 5.2: Main Menu Screen

When the Data Station is turned ON, the MAIN MENU screen,
depicted in the preceding figure, is displayed. The key labels
displayed across the bottom of this screen are used to access all of
the submenus that are available. The MAIN MENU screen displays
the following soft key labels:
SET UP
RUN
DATA LOG
RETIC DATA LOG*
QUALITY CONTROL
CALIBRATION
DIAGNOSTICS
SPECIAL PROTOCOLS

* The Retic Data Log is discussed in Chapter 14, Reticulocyte


Package.

CELL-DYN® 3700 System Operator’s Manual 5-3


9140320C — November 2000
Operating Instructions
Overview Chapter 5

Each of these MAIN MENU keys, in turn, accesses its own hierarchy
of screens and options. The different menus allow the operator to
perform various functions, such as configuring the system for
operation, running specimens, performing calibration and
diagnostic functions, reviewing data, and printing customized
reports.
The MAIN MENU screen is depicted in the preceding figure.
The upper left-hand corner shows the current version of the
instrument software. The upper right-hand corner shows the
current date and time, the operator ID, and the sequence number.
The information in the upper right corner is displayed on every
screen during operation.
NOTE: The cursor is positioned at the <OPERATOR ID>
entry field when the MAIN MENU screen is displayed. An
operator ID of up to three alphanumeric characters may be
entered. (An operator ID may also be entered from the
CALIBRATION screen.) This operator ID will be displayed on
all other screens and printed on all reports.

The Status Box is displayed in the top center of the screen. This
box appears on every screen to show the following:
• Menu in use (such as MAIN MENU)
• Analyzer status (such as READY)
• Other applicable information such as report or file
identity and any existing fault messages
Finally, the MAIN MENU key labels are displayed across the bottom
of the MAIN MENU screen.

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Operating Instructions
Chapter 5 Overview

Conventions Used in This Manual

The following conventions are used in this manual:


Information Presentation Examples
Note, Caution, Warning ALL CAPS, BOLDFACE NOTE:
Bulletin message, status, or other MONOSPACE FONT, Ready
screen display BOLDFACE
Data entry field <Sans Serif Font, Angle Brackets> <Date/Time>
Menu names SANS SERIF FONT, ALL CAPS SET UP
Soft key names [SANS SERIF FONT, ALL CAPS, [SET UP]
BRACKETS]
References to other text Bold: Bold & Italics Chapter: Title,
Subsection: Heading

Soft keys are also depicted as follows in margins and flowcharts:

MAIN MENU
KEYS

SUBMENU
KEYS

TOGGLE
KEYS

TOGGLE
KEYS

Flowchart Conventions
Menus are shown as square-cornered rectangles in the flowcharts,
and soft keys are shown as round-cornered rectangles:

MAIN MENU
Ready

SET UP RUN DATA LOG RETIC QUALITY


DATA LOG CONTROL

CELL-DYN® 3700 System Operator’s Manual 5-5


9140320C — November 2000
Operating Instructions
Overview Chapter 5

Menu Flowcharts
After pressing one of the MAIN MENU soft keys, the appropriate
submenu is displayed. From the submenus, more options are
available. The MAIN MENU options flowchart is shown on this page.
On the following pages, flowcharts show the submenus under
each MAIN MENU option.

Main Menu Flowchart

MAIN MENU
Ready

SET UP RUN DATA LOG RETIC QUALITY CALIBRA- DIAG- SPECIAL


DATA LOG CONTROL TION NOSTICS PROTOCOLS

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Operating Instructions
Chapter 5 Overview

Set Up Menu Flowchart

SET UP MENU
Ready

DATE/ PATIENT REAGENT QC SET UP OPERATION UNITS CUSTOMIZE MAIN


TIME LIMITS LOG MENU SET UP SELECTION REPORT

LIMIT LIMIT LIMIT LIMIT PRINT RETURN


SET 1 SET 2 SET 3 SET 4 TURN ON TURN ON BAR CODE COMPUTER RETURN
VET PKG RETIC PKG SET UP SET UP (to MAIN)
TURN OFF TURN OFF
VET PKG RETIC PKG TOGGLE SETUP
DELETE DILUENT WIC/HGB SHEATH DETERGENT PRINT RETURN
ENTRY LOG LYSE LOG LOG LOG LOG ON/OFF

REINIT STOP TOGGLE SET UP


X-B LAB ID QC SET UP CUSTOMIZE CUSTOMIZE MAIN INTERFACE TRANSMISS ON/OFF
SET UP SET UP LIMITS QC FILE DISPLAY PRINTOUT

CONFIRM CANCEL
STOP STOP
TURN X-B TURN X-B PRINT RETURN
RBC ON WBC ON
TURN X-B TURN X-B USA SI SI MOD SET 1 SET 2 SELECT RETURN
RBC OFF WBC OFF UNITS UNITS UNITS UNITS UNITS UNITS

UPDATE LOAD PRINT RETURN SELECT CANCEL STANDARD TOGGLE RETURN


RANGE
ENTRY FROM FILE FROM DISK PARAMETER SELECTION SELECTION ONE/ALL

MEANS/ PLACE
LIMITS PARAMETER
LOAD LOAD LOAD RETURN
LOW NORMAL HIGH
SELECT CANCEL STANDARD TOGGLE RETURN
PARAMETER SELECTION GROUPS ONE/ALL
PLACE CUSTOM
CONFIRM CANCEL LOT TOGGLE PRINT RETURN
UPDATE UPDATE NUMBER ON/OFF PARAMETER PLACEMENT

REPLICATE
ID
WBC RBC PLT DIFF LATEX CUSTOMIZE RETURN
GROUP GROUP GROUP GROUP SET PRINTOUT

CUSTOMIZE DISPLAYED REPORT


Ready

PARAM PARAM PARAM PARAM CUSTOMIZE CUSTOMIZE SELECT SET UP


SET 1 SET 2 SET 3 SET 4 PRINTOUT HEADER GRAPH

PARAM PARAM PARAM PARAM CUSTOMIZE CANCEL PLACE SET UP


SET 1 SET 2 SET 3 SET 4 PRINTOUT GRAPH GRAPH

CUSTOMIZE PRINTED REPORT CUSTOMIZE PRINTOUT HEADER


Ready Ready

TICKET CUSTOMIZE STOP CUSTOMIZE TOGGLE SET UP RESTORE BLANK CUSTOMIZE CUSTOMIZE SET UP
PRINTER HEADER HEADER DISPLAY PRINTOUT
DISPLAY PRINTING HEADER ON/OFF
RESTORE PRE-PRNTD GRAPHICS
HEADER TICKET PRINTER
BLANK CONFIRM CANCEL
TICKET STOP STOP

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9140320D — June 2003
Operating Instructions
Overview Chapter 5

Run Menu Flowchart

RUN
Ready

CLEAR WORK SPECIMEN CUSTOMIZE CHANGE PRINT PRINT MAIN


APERTURES LIST TYPE REPORT SAMPLER TICKET REPORT
CLEAR COLOR
FAULT PRINT
PRIME see CUSTOMIZE REPORT
of SET UP MENU

PATIENT QC BACK- ELECTRICL LATEX RESISTANT AUXILIARY RETURN


SPECIMEN GROUND BACKGRND RBC

WORK LIST BAR CODE INSERT/ DELETE PURGE WORK LIST PRINT RETURN
ON ON DELETE ALL COMPLETED SET UP WORK LIST
WORK LIST BAR CODE
OFF OFF
CONFIRM CANCEL TOGGLE RETURN
DELETION DELETION ON/OFF

INSERT DELETE RETURN CONFIRM CANCEL


PURGE PURGE

Data Log Menu Flowchart


DATA LOG
Ready

EDIT DISPLAY FIND REJECT CUSTOMIZE TRANSMIT PRINT MAIN


ID SPECIMEN SPECIMEN FROM X-B DATA LOG DATA DATA LOG
ACCEPT
INTO X-B

SELECT STANDARD CUSTOMIZE RETURN


PARAMETER GROUPS PRINTOUT

PLACE CANCEL RETURN SELECT STANDARD RETURN


PARAMETER SELECTION PARAMETER GROUPS

PLACE CANCEL RETURN


PARAMETER SELECTION

WBC RBC PLT DIFF CUSTOM CUSTOMIZE RETURN


GROUP GROUP GROUP GROUP PLACEMENT PRINTOUT

PREVIOUS NEXT EDIT CUSTOMIZE TRANSMIT PRINT PRINT RETURN


SPECIMEN SPECIMEN SPECIMEN REPORT SPECIMEN TICKET REPORT
COLOR
PRINT

CONFIRM CANCEL see CUSTOMIZE REPORT


of SET UP MENU

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9140320C — November 2000
Operating Instructions
Chapter 5 Overview

Quality Control Menu Flowchart

QC MENU
Ready

X-B X-B VIEW QC SET UP CUSTOMIZE CUSTOMIZE MAIN


SET UP FILE QC LOG LIMITS QC FILE DISPLAY PRINTOUT

TURN ON TURN ON PRINT RETURN


X-B RBC X-B WBC
SELECT CANCEL STANDARD TOGGLE RETURN
TURN OFF TURN OFF PARAMETER SELECTION SELECTION
X-B RBC X-B WBC ONE/ALL
PLACE
PARAMETER

X-B RBC X-B WBC PRINT RETURN SELECT CANCEL STANDARD TOGGLE RETURN
GRAPHS GRAPHS PARAMETER SELECTION GROUPS ONE/ALL
X-B RBC X-B WBC PLACE CUSTOM
DATA DATA PARAMETER PLACEMENT

WBC RBC PLT DIFF LATEX CUSTOMIZE RETURN


GROUP GROUP GROUP GROUP SET PRINTOUT

LOT TOGGLE PRINT RETURN


NUMBER ON/OFF
REPLICATE
ID

RANGE UPDATE LOAD PRINT RETURN


ENTRY FROM FILE FROM DISK
MEANS/
LIMITS

LOAD LOAD LOAD RETURN


LOW NORMAL HIGH
PURGE LEVEY- REJECT DELETE MOVE WRITE QC PRINT RETURN
QC LOG JENNINGS SPECIMEN SPECIMEN SPECIMEN TO DISK QC LOG
ACCEPT
SPECIMEN
CONFIRM CANCEL
CONFIRM CANCEL UPDATE UPDATE
PURGE PURGE CONFIRM CANCEL
DELETION DELETION

MOVE TO CANCEL
FILE MOVE

GROUP GROUP GROUP GROUP PRINT RETURN WRITE WRITE WRITE RETURN
1 2 3 4 LOW NORMAL HIGH

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9140320D — June 2003
Operating Instructions
Overview Chapter 5

Calibration Menu Flowchart

CALIBRATION
Ready

ENTER CALIBRATN AUTO- CLOSED PRINT MAIN


FACTOR LOG CALIBRATE SAMPLER
OPEN
SAMPLER
RESTORE RESET ALL RETURN
FACTORS TO 1.000
WHOLE CALIBRATR MPV CHANGE RETURN
BLOOD LATEX SAMPLER
CLOSED PRINT RETURN (CS MODEL
SAMPLER LOG ONLY)
OPEN
SAMPLER

EDIT START CONTINUE QUIT CLEAR PRINT RETURN


REF VAL AUTO-CAL AUTO-CAL AUTO-CAL REF VALS SUMMARY

CONFIRM PRINT CANCEL


QUIT SUMMARY QUIT

CONFIRM PRINT CANCEL


QUIT SUMMARY QUIT

EDIT START CONTINUE QUIT CLEAR PRINT RETURN


REF VAL AUTO-CAL AUTO-CAL AUTO-CAL REF VALS SUMMARY

PREVIOUS NEXT REPEAT INTERRUPT QUIT ACCEPT PRINT RETURN


SPECIMEN SPECIMEN SPECIMEN AUTO-CAL AUTO-CAL MEANS
CONTINUE
AUTO-CAL
CONFIRM CANCEL
CONFIRM CANCEL ACCEPT ACCEPT
REPEAT REPEAT

CONFIRM CANCEL
QUIT QUIT

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Operating Instructions
Chapter 5 Overview

Diagnostics Menu Flowchart

DIAGNOSTICS MENU
Ready

FAULT EXECUTION CNT RATE CLEAR RAW DATA MORE PRINT MAIN
REPORT TIMES SUMMARY FAULTS SUMMARY

WOC RBC PLT WIC PRINT RETURN


CNT RATE CNT RATE CNT RATE CNT RATE
WOC RBC PLT WIC
CNT GRAPH CNT GRAPH CNT GRAPH CNT GRAPH

MOTOR SOLENOID PUMP DRAIN INITIAL- MORE MAIN


OPERATION OPERATION OPERATION ACCUMULAT IZATION

DIGITAL VOLTAGE GAIN MORE PRINT MAIN


CYCLE STEP DIAG- READINGS READINGS ADJUSTMNT
BANK SOLENOID NOSTICS

VACUUM PRESSURE INHIBIT VACUUM PRESSURE DIAG-


ON ON PUMPS TEST TEST NOSTICS
VACUUM PRESSURE ENABLE
OFF OFF PUMPS

MOTOR PWR HOME EXERCISE SHEAR VAL SHEAR VAL PRINT DIAG-
CHECKING MOTORS MOTOR TIME DISPENSE NOSTICS
SHEAR VAL
ASPIRATE

FINISH SELECT DIGITAL VOLTAGE GAIN MORE PRINT MAIN


SELECT READINGS READINGS ADJUSTMNT

VERIFY ENTER AUTO GAIN CURRENT SIGNAL PRINT DIAG-


GAINS SETTINGS ADJUSTMNT SETTINGS GENERATOR NOSTICS

MAM SPM WIM PRINT RETURN


TESTING TESTING TESTING

WOC RBC PLT WIC MORE PRINT MAIN


DATA DATA DATA DATA
RBC PLT WIC
HISTOGRAM HISTOGRAM HISTOGRAM

AUTO-SAMP BAR CODE BAR CODE SERIAL MORE PRINT MAIN


VERSION ALIGNMENT VERIFY TEST

WOC 1 WOC 2 CALC SCATTER SMOOTHING EXTENDED PRINT DIAG- STOP TRANSMIT DIAG-
DATA DATA CV GRAPHS ON/OFF WOC COUNT NOSTICS TRANSMISS MESSAGE NOSTICS
WOC 1 WOC 2
HISTOGRAM HISTOGRAM

CELL-DYN® 3700 System Operator’s Manual 5-11


9140320C — November 2000
Operating Instructions
Overview Chapter 5

Special Protocols Menu Flowchart

SPECIAL PROTOCOLS
Ready

EMPTY REAGENT EMPTY MAINTEN CLEAN DISABLE MORE MAIN


XDUCERS RESERVOIR WOC LOG SHEAR VAL ANALYZER
FILL FILL RESTORE ENABLE
XDUCERS WOC SHEAR VAL ANALYZER

EMPTY EMPTY EMPTY EMPTY RETURN


DILUENT LYSE SHEATH DETERGENT
FILL FILL FILL FILL
DILUENT LYSE SHEATH DETERGENT

INTERVAL UPDATE PRINT & PRINT RETURN


SET UP LOG PURGE LOG

PRINT RETURN

FLUSH AUTO DAILY PREPARE CLEAN EXTEND MORE MAIN


SHEATH CLEAN SHUTDOWN SHIPPING NEEDLE AUTOCLEAN

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Operating Instructions
Chapter 5 Set Up Instructions

Set Up Instructions

When the [SET UP] key on the MAIN MENU screen is pressed, the
SET UP MENU screen is displayed. (See the following figure.) The
options accessible from this screen are used to configure the
system according to the laboratory’s requirements. The function
of each soft key is discussed on the following pages, and setup
procedures are included where applicable.

SET UP MENU Dec 15 1998 15:51


Ready Operator ID wam
Sequence # 0067

DATE/ PATIENT REAGENT QC SET UP OPERATION UNITS CUSTOMIZE MAIN


TIME LIMITS LOG MENU SET UP SELECTION REPORT

Figure 5.3: Set Up Menu Screen

SET UP The [SET UP] key is used to display the SET UP MENU screen. The
following soft key labels are displayed on this screen:
DATE/TIME
PATIENT LIMITS
REAGENT LOG
QC SET UP MENU
OPERATION SET UP
UNITS SELECTION
CUSTOMIZE REPORT
MAIN
These keys are used to set up the system for operation.

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9140320C — November 2000
Operating Instructions
Set Up Instructions Chapter 5

Date/Time Soft Key

DATE/TIME SET UP Dec 15 1998 15:52


Ready Operator ID rls
Sequence # 0067

Enter desired date display option and/or set date and time:

1 1 1: Month/Day/Year
2: Day/Month/Year
3: Year/Month/Day
4: Year/Day/Month

2 Date (Month/Day/Year): --/--/--

3 Time (00:00 to 23:59): --:--

RETURN

Figure 5.4: Date/Time Set Up Screen

DATE/ The [DATE/TIME] key on the SET UP MENU is used to display the
TIME DATE/TIME SET UP screen (shown in the preceding figure). This
screen is used to enter the date and time. This screen allows the
operator to select the format for displaying the date and to change
the date and time as required. Four different date formats are
available. The circled numbers shown in the preceding figure
correspond to the following numbered options:
1. The Display Format Selection Box is used to select the format
in which the date is displayed:
1: Month/Day/Year
2: Day/Month/Year
3: Year/Month/Day
4: Year/Day/Month
2. The <DATE> entry field contains the operator-entered date.
3. The <TIME> entry field contains the operator-entered time.

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Operating Instructions
Chapter 5 Set Up Instructions

The desired format is selected by typing the corresponding


number in the entry field displayed to the left of the list (1). When
the Enter key on the keyboard is pressed, the selected format is
displayed in the <DATE> entry field (2) and the cursor moves to the
entry position of this field. After the date has been entered, the
cursor moves to the <TIME> entry field (3).

Procedure: Date/Time
1. From the SET UP MENU screen, press the [DATE/TIME] key to
display the DATE/TIME SET UP screen.
2. Type the number of the desired format at the cursor.
3. Press the Enter key on the keyboard to save the entry and
advance the cursor to the <DATE> entry field.
4. Type the date in the selected format using one or two digits.
Separate the day, month, and year with a slash (/) or a
period (.). The entry order of the date should conform to
the date format just selected.
5. Press the Enter key on the keyboard to save the entry and
advance the cursor to the <TIME> entry field.
6. Type the time in the 24-hour (military) time format using
one or two digits. Separate the hours and minutes with a
colon (:) or a period (.).
7. Press the Enter key on the keyboard to save the entry.
8. Press the [RETURN] key to return to the SET UP MENU screen.

CELL-DYN® 3700 System Operator’s Manual 5-15


9140320C — November 2000
Operating Instructions
Set Up Instructions Chapter 5

Patient Limits Soft Key

LIMIT SET 1 Dec 15 1998 11:15


Ready Operator ID 732
Sequence # 6799

Lower Limits Upper Limits


WBC 4.6 K/uL 10.2 K/uL
NEU 2.0 K/uL 37.0 %N 6.9 K/uL 80.0 %N
LYM 0.6 K/uL 10.0 %L 3.4 K/uL 50.0 %L
MONO 0.0 K/uL 0.0 %M 0.9 K/uL 12.0 %M
EOS 0.0 K/uL 0.0 %E 0.7 K/uL 7.0 %E
BASO 0.0 K/uL 0.0 %B 0.2 K/uL 2.5 %B
RBC 4.04 M/uL 6.13 M/uL
HGB 12.2 g/dL 18.1 g/dL
HCT 37.7 % 53.7 %
MCV 80.0 fL 97.0 fL
MCH 27.0 pg 31.2 pg
MCHC 31.8 g/dL 35.4 g/dL
RDW 11.6 % 14.8 %
PLT 142. K/uL 424. K/uL
MPV 0.0 fL 99.9 fL
PCT 0.00 % 9.99 %
PDW 0.0 10(GSD) 99.9 10(GSD)

LIMIT LIMIT LIMIT PRINT RETURN


SET 2 SET 3 SET 4

Figure 5.5: Patient Limit Set Screen

PATIENT The [PATIENT LIMITS] key on the SET UP MENU is used to display one
LIMITS of the four LIMIT SET screens. (See the preceding figure.) These
screens are used to enter upper and lower flagging limits for
groups of patient samples. (For example, limits may be entered for
adult males, adult females, neonates, etc.) The following soft key
labels are displayed when the [PATIENT LIMITS] key is pressed:

LIMIT SET 1*
LIMIT SET 2*
LIMIT SET 3*
LIMIT SET 4*
PRINT
RETURN
* The key label for the limit set displayed on the screen is not
shown.
Whenever one of the four limit set soft keys is pressed, a screen
for that limit set is displayed and the soft key for that limit set is
no longer displayed. Four different sets of limits can be entered.

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Operating Instructions
Chapter 5 Set Up Instructions

Whenever a parameter result falls outside the entered limits, the


result is displayed in color on the screen to alert the operator.
Results displayed in yellow are below the limit, and results
displayed in purple are above the limit. The flagged result is
underlined on the graphics report and the blank ticket report. The
flagged result is marked with an asterisk (*) on the preprinted
ticket report.
It is suggested that one Patient Limit Set be used to enter
instrument-specific laboratory action limits. If the Interpretive
Report option is enabled, the Interpretive messages, such as
leukocytosis, anemia, thrombocytopenia, etc., will be displayed
when a result falls outside the appropriate limit. A result that falls
outside a laboratory action limit can also indicate the need for the
operator to follow a laboratory protocol, such as repeating the
sample, notifying the physician or performing a smear review. In
cases where a cellular abnormality is present that alters cellular
morphology to the point that the cells do not fit the criteria used
by the instrument to generate a flag, dispersional data alerts may
be the only flag(s) that will alert the operator to a potentially
erroneous result.

Interpretive Report Messages


In addition to the color-coded results and flags that alert the
operator to violations of limits, there is also a set of interpretive
report messages that can be displayed on the Patient Report. These
Interpretive Report Messages give causal indications for the limit
violation (for example, leukopenia for low WBC, anemia for low
RBC, thrombocytopenia for low PLT).
To set the system up to print Interpretive Report Messages, the
Print Interpretive Report option on the CUSTOMIZE PRINTED
REPORT screen must be selected.
If the Print Interpretive Report option on the CUSTOMIZE PRINTED
REPORT screen for the Graphics Printer is enabled, Interpretive
Report messages are printed on the report. This screen and its
options are discussed later in this section. The messages generated
by results that fall outside of the Patient Limits are listed in the
following sections.

WBC Messages
Leukopenia Result falls below the lower limit for WBC.
Leukocytosis Result exceeds the upper limit for WBC.
Neutropenia Result falls below the lower limit for
neutrophil absolute number.
Neutrophilia Result exceeds the upper limit for
neutrophil absolute number.

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Set Up Instructions Chapter 5

Lymphopenia Result falls below the lower limit for


lymphocyte absolute number.
Lymphocytosis Result exceeds the upper limit for
lymphocyte absolute number.
Monocytosis Result exceeds the upper limit for
monocyte absolute number.
Eosinophilia Result exceeds the upper limit for
eosinophil absolute number.
Basophilia Result exceeds the upper limit for basophil
absolute number.

RBC Messages
Anemia Result falls below the lower limit for RBCs.
Polycythemia Result exceeds the upper limit for RBCs.
Microcytic RBC Result falls below the lower limit for MCV.
Macrocytic RBC Result exceeds the upper limit for MCV.
Hypochromic Result falls below the lower limit for
MCHC.
Hyperchromic Result exceeds the upper limit for MCHC.
Anisocytosis Result exceeds the upper limit for RDW.

PLT Messages
Thrombocytopenia Result falls below the lower limit for PLTs.
Thrombocytosis Result exceeds the upper limit for PLTs.
Microcytic PLT Result falls below the lower limit for MPV.
Macrocytic PLT Result exceeds the upper limit for MPV.

Procedure: Patient Limit Sets


1. From the SET UP MENU screen, press the [PATIENT LIMITS] key
to display one of the four LIMIT SET screens.
NOTE: When a Patient Limit Set is displayed on the screen,
the set number (Limit Set 1, Limit Set 2, etc.) is displayed
in the Status Box. The other Limit Sets may be selected by
pressing the appropriate soft key.

2. Use the arrow keys on the keyboard to move the cursor to the
desired limit entry field and type the desired number.
3. Press the Enter key on the keyboard to save the entry and
automatically advance the cursor to the next entry position.
4. Repeat steps 2 and 3 until all desired entries have been made.
5. To obtain a printout of the Limit Set, press the [PRINT] key.

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Operating Instructions
Chapter 5 Set Up Instructions

NOTE: Retaining a hard copy of each Limit Set is


recommended, because the screens do not display names
or categories for the Limit Sets.

6. Press the appropriate soft key to select another Limit Set and
repeat steps 2–5 to enter the desired limits.
7. Press the [RETURN] key to return to the SET UP MENU screen.

Reagent Log Soft Key

DILUENT LOG Dec 15 1998 16:30


Ready Operator ID sh
Sequence # 0630

List Number Lot Number Expiration Date Open Date

-- 013511 02/28/20 12/02/98


-- 013511 02/28/20 12/17/98
-- --------- --/--/-- --/--/--
-- --------- --/--/-- --/--/--
-- --------- --/--/-- --/--/--
-- --------- --/--/-- --/--/--
-- --------- --/--/-- --/--/--
-- --------- --/--/-- --/--/--
-- --------- --/--/-- --/--/--
-- --------- --/--/-- --/--/--

DELETE WIC/HGB SHEATH DETERGENT PRINT MAIN


ENTRY LYSE LOG LOG LOG LOG

Figure 5.6: Diluent Log Screen

REAGENT The [REAGENT LOG] key is used to display one of the reagent logs.
LOG (The name of the displayed log is indicated in the Status Box.) Any
one of the other three reagent logs may be displayed by pressing
the appropriate soft key. The following soft key labels are
displayed when the [REAGENT LOG] key is pressed:
DELETE ENTRY
DILUENT LOG*
WIC/HGB LYSE LOG*
SHEATH LOG*
DETERGENT LOG*
PRINT LOG
MAIN
* The soft key for the reagent log currently displayed on the
screen is not shown.
CELL-DYN® 3700 System Operator’s Manual 5-19
9140320E — September 2004
Operating Instructions
Set Up Instructions Chapter 5

Each reagent log can hold 10 entries. The following information


may be entered for each reagent:
List Number Lot Number
Expiration Date Open Date

Procedure: Reagent Log Entry


1. From the SET UP MENU screen, press the [REAGENT LOG] key to
display a REAGENT LOG screen.
2. Use the appropriate soft key to select the desired reagent log
if it is not displayed.
3. Use the arrow keys on the keyboard to move the cursor to the
desired entry field.
4. Type the appropriate information.
NOTE: Entries for each field of information are optional.
Dates should be entered with a slash (/) or a period (.)
separating the month, day, and year.
5. Press the Enter key on the keyboard to save the entry and
advance the cursor.
6. Repeat steps 3–5 until all desired entries have been made.
7. To obtain a printout of the log, press the [PRINT LOG] key.
8. If desired, press the appropriate soft key to select another
reagent log and repeat steps 2–7 to enter data.

Procedure: Deleting Entries


When the log is full (the log can hold 10 entries), an existing
entry must be deleted or overwritten to create space for a new
entry. Abbott suggests that the log be printed for documentation
purposes when it is full.

1. From the SET UP MENU screen, press the [REAGENT LOG] key
to display a REAGENT LOG screen.
2. Move the cursor to the oldest entry in the log.
3. Press the [DELETE ENTRY] key. The [COMPLETE DELETION] and
the [RESTORE ENTRY] keys will be displayed.
4. Press the [COMPLETE DELETION] key to delete the selected
entry and create a space at the bottom of the log.
5. If desired, a new entry may then be made as directed in the
preceding Reagent Log Entry Procedure.
NOTE: New entries may also be made by typing over old
entries without deleting them.
6. Press the [RETURN] key to return to the SET UP MENU screen.

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Operating Instructions
Chapter 5 Set Up Instructions

QC Set Up Menu Soft Key

QC SET UP MENU Dec 15 1998 15:57


Ready Operator ID ebb
Sequence # 0067

File Name # Specimens File Name # Specimens

1. FILE 1 0 11. FILE 11 0


2. FILE 2 0 12. FILE 12 0
3. FILE 3 0 13. FILE 13 0
4. FILE 4 0 14. FILE 14 0
5. FILE 5 0 15. FILE 15 0
6. FILE 6 0 16. FILE 16 0
7. FILE 7 0 17. FILE 17 0
8. FILE 8 0 18. FILE 18 0
9. FILE 9 0 19. FILE 19 0
10. FILE 10 0 20. FILE 20 0

Select a QC file with the arrow keys or enter a new file name.

X-B LAB ID QC SET UP CUSTOMIZE CUSTOMIZE RETURN


SET UP SET UP LIMITS QC FILE DISPLAY PRINTOUT

Figure 5.7: QC Set Up Menu Screen

QC SET UP The [QC SET UP MENU] key is used to display a list of the QC files
MENU (see the preceding figure). This is the first of a series of screens
and menu options that allow the operator to set up the QC files.
The following soft key labels are displayed when the
[QC SET UP MENU] key is pressed:
X-B SET UP
LAB ID SET UP
QC LIMITS
SET UP QC FILE
CUSTOMIZE DISPLAY
CUSTOMIZE PRINTOUT
RETURN
NOTE: QC Set up for Reticulocytes is described in
Chapter 14: Reticulocyte Package.

CELL-DYN® 3700 System Operator’s Manual 5-21


9140320C — November 2000
Operating Instructions
Set Up Instructions Chapter 5

Set Up QC File Soft Key

QC FILE SET UP Nov 20 1998 15:33


Ready Operator ID sh
FOR Low Sequence # 0630

Lot Number: 12345

2 Expiration Date (Month/Day/Year): 12/30/98

3 WESTGARD RULE SELECTION:

ON RULE 1: Value outside 3 SD.

ON RULE 2: Two consecutive values outside SAME 2 SD.

ON RULE 3: Two consecutive values outside OPPOSITE 2 SD.

ON RULE 4: Two of three consecutive values outside SAME 2 SD.

ON RULE 5: Four consecutive values outside SAME 1 SD.

ON RULE 6: Ten consecutive values on SAME side of mean.

REPLICATE TOGGLE PRINT RETURN


ID ON/OFF

Figure 5.8: QC File Set Up (Lot Number Entry) Screen

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Operating Instructions
Chapter 5 Set Up Instructions

QC FILE SET UP Nov 20 1998 13:33


Ready Operator ID sh
FOR Low Sequence # 0630

1 Replicate ID: ------------

3 WESTGARD RULE SELECTION:

ON RULE 1: Value outside 3 SD.

ON RULE 2: Two consecutive values outside SAME 2 SD.

ON RULE 3: Two consecutive values outside OPPOSITE 2 SD.

ON RULE 4: Two of three consecutive values outside SAME 2 SD.

ON RULE 5: Four consecutive values outside SAME 1 SD.

ON RULE 6: Ten consecutive values on SAME side of mean.

LOT TOGGLE PRINT RETURN


NUMBER ON/OFF

Figure 5.9: QC File Set Up (Replicate ID Entry) Screen

SET UP The [SET UP QC FILE] key is used to configure the selected QC file.
QC FILE Pressing this key will display a QC FILE SET UP screen from which
the lot number or replicate ID can be entered, and the Westgard
Rules selected. If the file is used for a commercial control, the lot
number and expiration date may be entered by pressing the
[LOT NUMBER] key. If the file is used for a patient control, the ID
number of the control may be entered by pressing the
[REPLICATE ID] key. When the [SET UP QC FILE] key is pressed, the
following soft key labels are displayed:

REPLICATE ID or
LOT NUMBER (This key label alternates between
these two selections when the soft
key is pressed.)
TOGGLE ON/OFF (This key label is present only when
the cursor is in one of the Westgard
Rule Selection fields.)
PRINT
RETURN

CELL-DYN® 3700 System Operator’s Manual 5-23


9140320C — November 2000
Operating Instructions
Set Up Instructions Chapter 5

The QC FILE SET UP screens for <LOT NUMBER> entry and


<REPLICATE ID> entry are shown in the preceding two figures.
The numbers on these screens correspond to the following
numbered options:
1. <REPLICATE ID> entry field.
This entry field is displayed when the [REPLICATE ID] key is
pressed. This designation is intended for QC files that are
used for patient controls.
2. <LOT NUMBER> and <EXPIRATION DATE> entry fields.
These entry fields are displayed when the [LOT NUMBER] key
is pressed. This designation is intended for QC files that are
used for commercial controls.
3. WESTGARD RULE SELECTION:
RULE 1: Value outside 3 SD.
RULE 2: Two consecutive values outside
SAME 2 SD.
RULE 3: Two consecutive values outside
OPPOSITE 2 SD.
RULE 4: Two of three consecutive values
outside SAME 2 SD.
RULE 5: Four consecutive values outside
SAME 1 SD.
RULE 6: Ten consecutive values on SAME
side of mean.
NOTE: Westgard Rules are discussed in detail in Chapter
7: Quality Control within this manual.

The Westgard Rule selections are available on either of the


QC FILE SET UP screens.

Procedure: Set Up QC File


1. From the SET UP MENU screen, press the [QC SET UP MENU] key
to display the QC SET UP MENU screen.
2. Use the arrow keys on the keyboard to move the cursor to
the desired QC file.
3. Type the desired alphanumeric file name. (Up to 12
characters may be entered.)
4. Press the Enter key on the keyboard to save the entry and
advance the cursor to the next QC file.

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Operating Instructions
Chapter 5 Set Up Instructions

5. Use the arrow keys on the keyboard to move the cursor back
into the selected file.
6. Press the [SET UP QC FILE] key to display the QC FILE SET UP
screen.

Procedure: Lot Number Entry


1. From the QC FILE SET UP screen, press the [LOT NUMBER] key
if required to display the <Lot Number> and <Expiration Date>
entry fields.
2. The cursor begins in the <Lot Number> entry field. Type the
lot number and press the Enter key on the keyboard to save
the entry. The cursor is now on the <Expiration Date> entry
field.
3. Type the expiration date in the format indicated using one
or two digits. This is the same format selected on the
DATE/TIME SET UP screen. Separate the digits with a slash (/)
or a period (.).
4. Press the Enter key on the keyboard to save the entry and
advance the cursor to the <WESTGARD RULE SELECTION>
entry fields.
5. Use the arrow keys on the keyboard to position the cursor at
the desired Westgard Rule.
6. Press the [TOGGLE ON/OFF] key to enable or disable the rule
and advance the cursor.
7. Repeat steps 5 and 6 until all desired rule selections have
been made.
8. To obtain a printout of the entries, press the [PRINT] key.
9. Press [RETURN] to return to the QC FILE SET UP screen.

Procedure: Replicate ID Entry


1. From the QC FILE SET UP screen, press the [REPLICATE ID] key
if required to display the <Replicate ID> entry field.
2. The cursor begins in the <Replicate ID> entry field. Type the
sample ID number. (Up to 12 alphanumeric characters may
be entered.) Press the Enter key on the keyboard to save the
entry and advance the cursor to the
<WESTGARD RULE SELECTION> entry fields.
3. Select the Westgard Rules as directed in the preceding
procedure (Procedure: Lot Number Entry).

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Lab ID Set Up Soft Key


LAB ID The [LAB ID SET UP] key enables the entry of QC limits into a QC
SET UP file from a floppy disk.
The [LAB ID SET UP] key on the QC SET UP MENU is used to enter
Laboratory identification information for the QC files. This
information is necessary for participants in the CELL-DYN
Interlaboratory QC Program who wish to submit their results on
a floppy disk. Laboratory Identification information must be
entered before QC data can be transferred to the floppy disk.

Procedure: Lab ID Set Up Soft Key


1. From the MAIN MENU screen, press the [SET UP] key followed
by [QC SET UP MENU]
2. From the QC SET UP screen, press [LAB ID SET UP] to display
the LAB ID SET UP screen.
3. Type the appropriate information and press the Enter key on
the keyboard after each entry to save it and advance the
cursor to the next entry field.
4. If desired, press the Print Screen key on the keyboard to
obtain a printout of the entered information.
5. Press [RETURN] to return to the QC SET UP screen.

QC Limits Soft Key


QC The [QC LIMITS] key is used to display the QC MEANS/LIMITS ENTRY
LIMITS screen and the following soft key labels:
RANGE ENTRY or
MEANS/LIMITS (This key label alternates between these
two selections when the soft key is
pressed.)
UPDATE FROM FILE
LOAD FROM DISK
PRINT
RETURN
QC limits are entered by pressing the [QC LIMITS] key. This key is
available on both the QC SET UP MENU screen and the QC MENU
screen. The QC MENU screen is discussed in Chapter 7: Quality
Control. Two types of QC limits are available:

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Range Entry The [RANGE ENTRY] key is used to enter the


upper and lower flagging limits as
absolute numbers (see the following
figure).
Means and Limits The [MEANS/LIMITS] key is used to enter the
mean value and a ± range value that
defines the upper and lower flagging
limits (see Figure 5.11, QC Means/Limits
Entry Screen).
If the RANGE ENTRY screen is selected by pressing the
[RANGE ENTRY] key, the current upper and lower limits for the
selected file will be displayed as described above. If the
MEANS/LIMITS screen is selected by pressing the [MEANS/LIMITS]
key, the current means and limits for the selected file will be
displayed as described above.

QC RANGE ENTRY Nov 21 1998 16:24


Ready Operator ID 757
FOR LOW Sequence # 9110

Lower Limits Upper Limits Lower Limits Upper Limits


WOC 2.0 K/uL 2.6 K/uL %B 0.0 %B 6.5 %B
WIC 2.0 K/uL 2.6 K/uL RBC 2.33 M/uL 2.63 M/uL
WBC 2.0 K/uL 2.6 K/uL HGB 6.6 g/dL 7.2 g/dL
NEU 1.1 K/uL 2.3 K/uL HCT 18.5 % 21.5 %
%N 66.5 %N 80.5 %N MCV 78.8 fL 82.8 fL
LYM 0.0 K/uL 0.9 K/uL MCH 25.8 pg 29.8 pg
%L 7.6 %L 21.6 %L MCHC 31.4 g/dL 37.4 g/dL
MONO 0.0 K/uL 0.4 K/uL RDW 13.8 % 17.8 %
%M 3.4 %M 13.4 %M PLT 43. K/uL 61. K/uL
EOS 0.0 K/uL 0.1 K/uL MPV 9.4 fL 11.4 fL
%E 0.0 %E 5.0 %E PCT 0.05 % 0.07 %
BASO 0.0 K/uL 0.5 K/uL PDW 14.8 10(GSD) 16.2 10(GSD)

MEANS/ UPDATE LOAD PRINT RETURN


LIMITS FROM FILE FROM DISK

Figure 5.10: QC Range Entry Screen

Procedure: Range Entry


1. Select a file from the QC SET UP MENU screen by using the
arrow keys on the keyboard to move the cursor into the
desired file.
2. Press the [QC LIMITS] key (followed by the [RANGE ENTRY] key
if required) to display the QC RANGE ENTRY screen for the
selected file.

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3. Use the arrow keys on the keyboard to move the cursor to


the desired entry field.
4. Type the appropriate numbers and press the Enter key on
the keyboard to save each entry and advance the cursor to
the next entry field.
5. Repeat step 4 until all entries have been made.
6. To obtain a printout of the entered values, press the [PRINT]
key.
7. Press [RETURN] to save the entries and return to the
QC SET UP MENU screen.
NOTE: When the entries are saved, the software
automatically checks to see if any entries would result in
the upper limit being less than the lower limit. If this
situation occurs, the limits will automatically be reversed
and the Bulletin line will display the following message:
LIMITS WERE EXCHANGED TO MAKE UPPER > LOWER.

QC MEANS/LIMITS ENTRY Dec 18 1998 11:35


Ready Operator ID C03
FOR CONTROL H Sequence # 4300

Means Limits(+/-) Means Limits(+/-)


WOC 50.0 K/uL 50.0 K/uL %B 5.00 %B 5.00 %B
WIC 50.0 K/uL 50.0 K/uL RBC 50.0 M/uL 50.0 M/uL
WBC 50.0 K/uL 50.0 K/uL HGB 50.0 g/dL 50.0 g/dL
NEU 50.0 K/uL 50.0 K/uL HCT 500. % 500. %
%N 50.0 %N 50.0 %N MCV 50.0 fL 50.0 fL
LYM 50.0 K/uL 50.0 K/uL MCH 50.0 pg 50.0 pg
%L 50.0 %L 50.0 %L MCHC 50.0 g/dL 50.0 g/dL
MONO 50.0 K/uL 50.0 K/uL RDW 500. % 500. %
%M 50.0 %M 50.0 %M PLT 50.0 K/uL 50.0 K/uL
EOS 50.0 K/uL 50.0 K/uL MPV 5.00 fL 5.00 fL
%E 50.0 %E 50.0 %E PCT 50.0 % 50.0 %
BASO 50.0 K/uL 50.0 K/uL PDW 50.0 10(GSD) 50.0 10(GSD)

RANGE UPDATE LOAD PRINT RETURN


ENTRY FROM FILE FROM DISK

Figure 5.11: QC Means/Limits Entry Screen

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Procedure: Means/Limits Entry


1. Select a file from the QC SET UP MENU screen by using the
arrow keys on the keyboard to move the cursor into the
desired file.
2. Press the [QC LIMITS] key (followed by the [MEANS/LIMITS] key
if required) to display the QC MEANS/LIMITS ENTRY screen for
the selected file.
3. Use the arrow keys on the keyboard to move the cursor to
the desired entry field.
4. Type the appropriate numbers and press the Enter key on
the keyboard to save each entry and advance the cursor to
the next entry field.
5. Repeat step 4 until all entries have been made.
6. Press the [RETURN] key to save the entries and return to the
QC SET UP MENU screen.
NOTE: When the entries are saved, the software
automatically checks to see if any entries would result
in a negative number for the lower limit (for example,
mean = 1.0 and limit = 2.0). If a negative number is found,
the values are automatically edited to adjust the lower
limit to zero and the bulletin line will display the
following message: LIMITS WERE CHANGED TO
CORRECT OUT-OF-RANGE VALUES.
In the above example, the mean would be adjusted to 1.5
and the limit would be adjusted to 1.5.

7. If desired, press the [QC LIMITS] key to return to the


MEANS/LIMITS ENTRY screen and press the [PRINT] key to
obtain a printout of the entered values.

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Update From File Soft Key

QC MEANS/LIMITS ENTRY Dec 21 1998 16:24


Ready Operator ID sh
FOR Normal Sequence # 0630

Means Limits(+/-) Means Limits(+/-)


WIC 7.5 K/uL 0.6 K/uL %B 2.7 %B 2.7 %B
WOC 7.5 K/uL 0.6 K/uL RBC 4.21 M/uL 0.18 M/uL
WBC 7.5 K/uL 0.6 K/uL HGB 12.5 g/dL 0.4 g/dL
NEU 4.8 K/uL 1.5 K/uL HCT 39.1 % 2.4 %
%N 64.0 %N 7.0 %N MCV 92.9 fL 3.0 fL
LYM 1.5 K/uL 0.8 K/uL MCH 29.7 pg 2.0 pg
%L 20.8 %L 10.0 %L MCHC 32.0 g/dL 3.0 g/dL
MONO 0.8 K/uL 0.5 K/uL RDW 15.6 % 2.2 %
%M 10.7 %M 3.5 %M PLT 229. K/uL 25. K/uL
EOS 0.2 K/uL 0.2 K/uL MPV 10.3 fL 1.0 fL
%E 2.7 %E 1.5 %E PCT 5.00 % 4.99 %
BASO 0.2 K/uL 0.2 K/uL PDW 50.0 10(GSD) 50.0 10(GSD)

RANGE UPDATE LOAD PRINT RETURN


ENTRY FROM FILE FROM DISK

Figure 5.12: QC Means/Limits Entry Screen Showing the Update From File
Key

UPDATE The [UPDATE FROM FILE] key is displayed on the


FROM FILE QC MEANS/LIMITS ENTRY and QC RANGE ENTRY screens (see the
preceding figure). Pressing this key will cause the bulletin line to
display the message USE CONFIRM UPDATE TO SET MEANS
AND LIMITS FROM QC FILE, and the following soft key labels
will be displayed:
CONFIRM UPDATE
CANCEL UPDATE
These keys are used to confirm or cancel the Update From File
command.
NOTE: A message <Cannot UPDATE from FILE.
File must have at least 2 valid values per
parameter> is displayed on the bulletin line if there are
less than 2 results in the file.

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If the [CONFIRM UPDATE] key is pressed, the mean value for each
parameter will be computed from the values in the file. The
parameter limits are set as follows:
WBC, PLT, RDW, and MPV: ± 10% of the computed mean
NEU, LYM, and MONO: ± 40% of the computed mean
Remaining Parameters: ± 5% of the computed mean

Load From Disk Soft Key

LOAD
FROM DISK
The [LOAD FROM DISK] key is used to enter the lot number,
expiration date, and assay values into a QC file directly from a
floppy disk. When this option is used, the lot number, expiration
date, mean value and limits (either for QC Range entry or QC
Means/Limits entry) are automatically entered in the selected file.
The values may be edited after they are displayed on the screen.
NOTE: The information is entered for each level, one level
at a time.

Procedure: Load From Disk


1. Press [QUALITY CONTROL] to display a list of QC files.
2. Use the arrow keys on the keyboard to move the cursor to
the desired file. Type the file name (e.g., Low L0036) and
press the Enter key on the keyboard to save the name and
advance the cursor to the next file.
NOTE: The file must be empty in order to load the
information from the disk.

3. When the desired files have been named, use the Arrow keys
on the keyboard to move the cursor back to the first file
desired for data entry.
4. Press [QC LIMITS] followed by [MEANS/LIMITS] or
[RANGE ENTRY] to display the QC MEANS/LIMITS ENTRY or
RANGE ENTRY screen for the selected file.
5. Press [LOAD FROM DISK] to display the LOAD FROM DISK
screen.
6. Insert the disk containing the assay information for the
relevant lot number into the Data Station disk drive.
NOTE: Be certain to carefully check lot numbers. Be sure
the lot number on the disk matches the lot number that is
being put into use. If the lot number is included in the
filename, be sure the disk contains assay information for
that lot number.

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7. Check the status box to be sure the correct file is selected and
press the appropriate soft key:
[LOAD LOW] to load the low control assay data.
[LOAD NORMAL] to load the normal control assay data.
[LOAD HIGH] to load the high control assay data.
8. The limits are displayed for the selected file. If desired, the
limits may be edited.
9. Press [RETURN] to return to the QC MENU screen.
10. Select the next file and repeat steps 7 and 8 to load the assay
data for the appropriate level of control.
11. When all the assay data has been loaded, remove the disk
from the disk drive.

Customize Display Soft Key

CUSTOMIZE QC DISPLAY Dec 21 1998 16:23


Ready Operator ID
FOR FILE 1 Sequence # 0067

Customize QC display for all QC files

Group 1: WBC NEU LYM MONO EOS BASO

Group 2: RBC HGB HCT MCV MCH MCHC RDW

Group 3: PLT MPV PCT PDW

Group 4: WBC %N %L %M %E %B

WBC NEU LYM MONO EOS BASO


RBC HGB HCT MCV MCH MCHC RDW
PLT MPV PCT PDW
%N %L %M %E %B
RUT1 RUT2 RCT1 RCT2
WUT WCT WIC WOC EMPTY

SELECT STANDARD TOGGLE RETURN


PARAMETER GROUPS ONE/ALL

Figure 5.13: Customize QC Display Screen

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The [CUSTOMIZE DISPLAY] key is used to display the


CUSTOMIZE
DISPLAY CUSTOMIZE QC DISPLAY screen for the selected file. This screen
allows the operator to customize the display of information in
the QC logs. (See the preceding figure.) The following soft key
labels are displayed on the CUSTOMIZE QC DISPLAY screen:
SELECT PARAMETER
STANDARD GROUPS
TOGGLE ONE/ALL
RETURN
The screen displays a matrix showing the groups of parameters
that are currently selected. A list of all available parameters is
displayed under the matrix. There are several additional
parameters included in the list that may be displayed in the
QC file if desired. These include the following:
RUT1 and RUT2 RUT1 is the RBC/PLT Upper Metering
Time. RUT2 is the RBC/PLT Upper
Metering Time for an extended count.
RCT1 and RCT2 RCT1 is the RBC/PLT Count Time. RCT2 is
the RBC/PLT Count Time for an extended
count.
WUT WUT is the WIC Upper Metering Time.
WCT WCT is the WIC Count Time.
WIC WIC is the WBC Impedance Count.
WOC WOC is the WBC Optical Count.
EMPTY EMPTY inserts an empty column in the
display.
SELECT The [SELECT PARAMETER] key is used to select parameters and
PARAMETER place them in the desired location.

STANDARD
The [STANDARD GROUPS] key is used to select a predetermined
GROUPS group of parameters that will be placed on a designated page.
The display may be customized by selecting the individual
parameters, standard groups of parameters, or a combination of
the two.
On the CUSTOMIZE QC DISPLAY screen, the selections included in
Parameter Group 1 will be displayed (in the order indicated from
left to right) on the first VIEW QC LOG screen. The remaining
groups will be displayed on subsequent screens that are accessed
by pressing the right arrow key on the keyboard. The left arrow
key is used to page back through the screens to the first screen.
The VIEW QC LOG screen is discussed in Chapter 7: Quality Control.
TOGGLE The [TOGGLE ONE/ALL] key is used to customize one file only or all
ONE/ALL files the same way.

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Procedure: Customize QC Log Display


1. Select a file from the QC SET UP MENU screen by moving the
cursor to the desired file.
2. Press the [CUSTOMIZE DISPLAY] key to display the
CUSTOMIZE QC DISPLAY screen for the selected file.
3. If necessary, press the [CUSTOM PLACEMENT] key to display
the CUSTOMIZE QC DISPLAY screen and the
[SELECT PARAMETER] key.
4. Use the arrow keys on the keyboard to move the cursor to
the desired parameter in the listing under the matrix.
5. Press the [SELECT PARAMETER] key. The selected parameter
will be highlighted and the cursor will move to the first
position in <Group 1>.
NOTE: The key label will change to [PLACE PARAMETER],
and a [CANCEL SELECTION] key will be displayed.

6. If necessary, use the arrow keys on the keyboard to move


the cursor to the desired location and press the
[PLACE PARAMETER] key.
NOTE: When the [PLACE PARAMETER] key is pressed, the
selected parameter is displayed in the position indicated
by the cursor and the cursor is then advanced to the next
parameter in the listing under the matrix.

7. Repeat steps 4–6 until all selections have been made.


8. If desired, press the Print Screen key on the keyboard to
obtain a printout of the selected groups.
9. Press the [RETURN] key to return to the QC SET UP MENU
screen.
10. Repeat this procedure to customize the display for other
QC logs.
NOTE: Use the [TOGGLE ONE/ALL] key to customize one
file only or all files in the same manner.

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Standard Groups Soft Key

CUSTOMIZE QC DISPLAY Dec 21 1998 16:23


Ready Operator ID
FOR FILE 1 Sequence # 0067

Customize QC display for the current file

Group 1: WBC NEU LYM MONO EOS BASO

Group 2: RBC HGB HCT MCV MCH MCHC RDW

Group 3: PLT MPV PCT PDW

Group 4: WBC %N %L %M %E %B

WBC NEU LYM MONO EOS BASO


RBC HGB HCT MCV MCH MCHC RDW
PLT MPV PCT PDW
%N %L %M %E %B
RUT1 RUT2 RCT1 RCT2
WUT WCT WIC WOC EMPTY

WBC RBC PLT DIFF LATEX CUSTOM TOGGLE RETURN


GROUP GROUP GROUP GROUP SET PLACEMENT ONE/ALL

Figure 5.14: Customize QC Display Screen Showing Standard Groups

STANDARD Predetermined groups of parameters, called Standard Groups,


GROUPS may be selected by pressing the [STANDARD GROUPS] key. The
preceding figure shows the CUSTOMIZE QC DISPLAY screen with the
Standard Groups displayed. The following soft key labels are
displayed when the [STANDARD GROUPS] key is pressed:
WBC GROUP
RBC GROUP
PLT GROUP
DIFF GROUP
LATEX SET
CUSTOM PLACEMENT (This key is used to return to the
CUSTOMIZE QC DISPLAY screen for
operator-selected placement.)
TOGGLE ONE/ALL
RETURN

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The WBC, RBC, PLT, and DIFF Standard Groups are shown in the
preceding figure. They contain the following parameters:
WBC Group (Group 1):WBC, NEU, LYM, MONO, EOS, BASO
RBC Group (Group 2): RBC, HGB, HCT, MCV, MCH, MCHC,
RDW
PLT Group (Group 3): PLT, MPV, PCT, PDW
DIFF Group (Group 4): WBC, %N, %L, %M, %E, %B

Procedure: Customize QC Log Display


(Standard Groups)
1. Select a file from the QC SET UP MENU screen by moving the
cursor to the desired file.
2. Press the [CUSTOMIZE DISPLAY] key to display the
CUSTOMIZE QC DISPLAY screen for the selected file.
3. Press the [STANDARD GROUPS] key to display the
CUSTOMIZE QC DISPLAY screen and key labels for Standard
Groups.
4. Use the arrow keys on the keyboard to move the cursor to
the desired group location (1–4).
NOTE: This number indicates the order in which the
group of parameters will be displayed (Group 1 on the
first screen, Group 2 on the second, etc.).

5. Press the soft key corresponding to the desired parameter


group. This group will be displayed in the position indicated
by the cursor.
6. Repeat steps 4 and 5 until all desired groups have been
selected.
7. To obtain a printout of the configuration, press the Print
Screen key on the keyboard.
8. Press the [RETURN] key to return to the QC SET UP MENU
screen.
9. Repeat this procedure to select Standard Groups for other
QC logs.

Latex Set Soft Key


LATEX The [LATEX SET] key is used to customize the QC file to store
SET information generated by polystyrene microspheres. Information
is stored for each of the four angles of scatter used to determine
the differential. This key is intended for Abbott service personnel.
TOGGLE The [TOGGLE ONE/ALL] key is used to customize one file only or all
ONE/ALL
files the same way.

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Customize Printout Soft Key

CUSTOMIZE QC PRINTOUT Dec 21 1998 16:23


Ready Operator ID sh
FOR Normal Sequence # 0630

Customize QC PRINTOUT for the current QC file

WBC %N %L %M %E %B RBC HGB HCT MCV MCH MCHC

RDW PLT MPV PCT PDW

WBC NEU LYM MONO EOS BASO


RBC HGB HCT MCV MCH MCHC RDW
PLT MPV PCT PDW
%N %L %M %E %B
RUT1 RUT2 RCT1 RCT2
WUT WCT WIC WOC EMPTY

SELECT STANDARD TOGGLE RETURN


PARAMETER SELECTION ONE/ALL

Figure 5.15: Customize QC Printout Screen

CUSTOMIZE The [CUSTOMIZE PRINTOUT] key on the QC SET UP MENU screen is


PRINTOUT used to display the CUSTOMIZE QC PRINTOUT screen, which is used
to customize the printout format for the QC logs. (See the
preceding figure.) The following soft key labels are displayed on
this screen:

SELECT PARAMETER or
PLACE PARAMETER (This key label alternates between
these two selections.)
STANDARD SELECTION
TOGGLE ONE/ALL
RETURN

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The CUSTOMIZE QC PRINTOUT screen displays the group of


parameters that is currently selected. A list of all available
parameters is displayed under the selected group. The following
parameters are also included in this list and can be printed in the
QC Log if desired:

RUT1 and RUT2 RUT1 is the RBC/PLT Upper Metering


Time. RUT2 is the RBC/PLT Upper
Metering Time for an extended count.
RCT1 and RCT2 RCT1 is the RBC/PLT Count Time. RCT2 is
the RBC/PLT Count Time for an extended
count.
WUT WUT is the WIC Upper Metering Time.
WCT WCT is the WIC Count Time.
WIC WIC is the WBC Impedance Count.
WOC WOC is the WBC Optical Count.
SELECT The [SELECT PARAMETER] key is used to select parameters and
PARAMETER place them in the desired location.

STANDARD The [STANDARD SELECTION] key is used to automatically arrange


SELECTION the parameters in the predetermined print group shown in the
preceding figure.

TOGGLE The [TOGGLE ONE/ALL] key is used to customize one file only or all
ONE/ALL files the same way.

Procedure: Customize QC Log Printout


1. Select a file from the QC SET UP MENU screen by moving the
cursor to the desired file.
2. Press the [CUSTOMIZE PRINTOUT] key to display the
CUSTOMIZE QC PRINTOUT screen for the selected file.
3. Use the arrow keys on the keyboard to move the cursor to
the desired parameter in the list under the printout group.
4. Press the [SELECT PARAMETER] key. The selected parameter
will be highlighted and the cursor will move to the first
position in the group.
NOTE: The key label will change to [PLACE PARAMETER]
and a [CANCEL SELECTION] key will be displayed.

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5. If necessary, use the arrow keys on the keyboard to move


the cursor to the desired location and press the
[PLACE PARAMETER] key.
NOTE: When the [PLACE PARAMETER] key is pressed,
the selected parameter will be displayed in the position
indicated by the cursor and the cursor will then be
advanced to the next parameter in the list under the
printout group.

6. Repeat steps 3–5 until all entries have been made.


7. To obtain a printout of the configuration, press the Print
Screen key on the keyboard.
8. Press the [RETURN] key to return to the QC SET UP MENU
screen.
9. Repeat this procedure to customize the printout for other
QC Logs.

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X-B Set Up Soft Key

X-B SET UP Nov 18 1998 08:49


Ready Operator ID
Sequence # 0067

The X-B RBC program is ON.

1 2 3
Parameter Lower/Upper Limits Target Value Action Limit
MCV 55.0/125. fL 89.9 fL 3.0 %
MCH 20.0/40.0 pg 30.5 pg 3.0 %
MCHC 24.0/44.0 g/dL 33.9 g/dL 3.0 %
The X-B WBC program is ON.
Parameter Lower/Upper Limits Target Value Action Limit
LYM 0D 48/ 70 Channel 59 Channel 7.0 %
LYM 10D 51/ 67 Channel 59 Channel 5.0 %
NEU 0D 141/179 Channel 160 Channel 4.0 %
NEU 10D 128/170 Channel 149 Channel 5.0 %
NEU 90D 87/163 Channel 125 Channel 10.0 %
NEU 90DEP 11/ 31 Channel 21 Channel 19.0 %
NEU-EO 14.0/ 32.0 Degree 23.0 Degree 13.0 %

TURN X-B TURN X-B PRINT RETURN


RBC OFF WBC OFF

Figure 5.16: X-B Set Up Screen

X-B The [X-B SET UP] key on the QC SET UP MENU screen is used to
SET UP display the X-B SET UP screen. (See the preceding figure.) This
screen is used to enter upper and lower acceptance limits, target
values, and action limits for the X-B Moving Average QC
Program. The following soft key labels are displayed when the
[X-B SET UP] key is pressed:

TURN X-B RBC ON or


TURN X-B RBC OFF (This key label alternates between
these two selections.)
TURN X-B WBC ON or
TURN X-B WBC OFF (This key label alternates between
these two selections.)
PRINT
RETURN

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The numbers on the X-B SET UP screen shown in the preceding


figure correspond to the following numbered options:
1. Lower/Upper Limits
The Lower and Upper Limits determine which patient
results will be used in the X-B RBC and WBC Moving
Average calculations. Results that fall outside these limits
are automatically excluded from the appropriate X-B
calculations. These limits should be set wide to exclude
grossly abnormal samples that would bias the calculation,
but the limits should include at least 95% of the patient
results.
2. Target Value
The Target Values for the X-B RBC and WBC Analyses are
similar to the assay values for commercial controls. They are
derived from the patient populations that are analyzed on
the instrument.
3. Action Limit
The Action Limits are the acceptable limits of variation
around the X-B RBC and X-B WBC target values.
NOTE: The X-B Program is discussed in detail in Chapter 7:
Quality Control.

Procedure: X-B Set Up


1. From the QC SET UP MENU screen, press the [X-B SET UP] key
to display the X-B SET UP screen.
2. Use the arrow keys on the keyboard to move the cursor to
the desired entry field.
3. Type the appropriate numbers and press the Enter key on
the keyboard to save the entry and advance the cursor to the
next entry field.
4. Repeat steps 2 and 3 until all entries have been made.
5. To obtain a printout of the entered values, press the [PRINT]
key.
6. Press the [TURN X-B RBC ON] key to enable the X-B RBC
Program if this key label is displayed.
NOTE: When the X-B RBC Program is enabled, the screen
displays the message THE X-B RBC PROGRAM IS ON,
and the [TURN X-B RBC OFF] key is displayed.

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7. Press the [TURN X-B WBC ON] key to enable the X-B WBC
Program if this key label is displayed.
NOTE: When the X-B WBC Program is enabled, the screen
displays the message The X-B WBC Program is ON,
and the [TURN X-B WBC OFF] key is displayed.

8. Press the [RETURN] key to return to the QC SET UP MENU


screen.

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Operation Set Up Soft Key

OPERATION SET UP MENU Dec 08 1998 16:11


Ready Operator ID rwe
Sequence # 0067

To turn on the RETIC PKG you must enter to operator ID and the
instrument must be in Open mode. To turn on the VET PKG you must
exit the RETIC PKG.

TURN ON TURN ON BAR CODE COMPUTER RETURN


VET PKG RETIC PKG SET UP SET UP

Figure 5.17: Operation Set Up Menu Screen

OPERATION The [OPERATION SET UP] key on the SET UP MENU screen is used to
SET UP display the OPERATION SET UP MENU screen (see the preceding
figure). This screen allows the operator to select the type of bar
code used and configure the transmission to an on-line computer.
The Veterinary Package and the Reticulocyte Package for the
CELL-DYN 3700 System can be enabled or disabled from this
screen. The following soft key labels are displayed on the
OPERATION SET UP MENU screen:

TURN ON VET PKG or


TURN VET PKG OFF (This key label alternates between
these two selections.)
TURN ON RETIC PKG or
TURN OFF RETIC PKG (This key label alternates between
these two selections.)
BAR CODE SET UP
COMPUTER SET UP
RETURN

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Set Up Instructions Chapter 5

Turn ON Vet Package Soft Key


TURN ON The [TURN ON VET PKG] or [TURN VET PKG OFF] key enables or
VET PKG disables the Veterinary Package. This option is used to configure
TURN VET the instrument to run various types of animal specimens. The
PKG OFF
Veterinary Package is discussed in detail in Chapter 13:
Veterinary Package.

Turn ON Retic Package Soft Key


TURN ON The [TURN ON RETIC PKG] or [TURN OFF RETIC PKG] key enables or
RETIC PKG disables the Reticulocyte Package. This option is used to analyze a
TURN OFF whole blood specimen for reticulocytes. The Reticulocyte
RETIC PKG
Package is discussed in Chapter 14: Reticulocyte Package.

Bar Code Set Up Soft Key

BAR CODE SET UP Dec 08 1998 16:12


Ready Operator ID agw
Sequence # 0068

ON Bar Code Check Digit


1 Bar Code Symbology (1=CODE39, 2=I2OF5, 3=CODABAR, 4=CODE128)

SET UP

Figure 5.18: Bar Code Set Up Screen

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The [BAR CODE SET UP] key is used to display the BAR CODE SET UP
BAR CODE
SET UP screen, which is used to select the type of bar code to be read and
to enable or disable the Check Digit option for a specific bar
code. (See the preceding figure.) If the Check Digit option is
enabled, the Analyzer reads only the type of bar code selected. If
the option is disabled, the Analyzer ignores the selected bar code
and reads all four types of bar codes (Code 39, Interleaved 2 of 5,
Codabar, and Code 128).

NOTE: For more information about Check Digits and bar


codes, refer to Appendix A: Bar Codes.

Procedure: Bar Code Set Up


1. From the OPERATION SET UP MENU screen, press the
[BAR CODE SET UP] key to display the BAR CODE SET UP
screen.
2. Place the cursor on the Bar Code symbology line and type
the number for the type of bar code that will be used:
1 — Code 39
2 — Interleaved 2 of 5
3 — Codabar
4— Code 128
Press the Enter key on the keyboard to save the entry and
advance the cursor.
3. When the cursor is next to the <BAR CODE CHECK DIGIT>
entry field, a [TOGGLE ON/OFF] key is displayed. Press this key
to enable or disable the Check Digit option. When the
Check Digit option is turned off, the Bar Code symbology
line is not displayed.
NOTE: The [TOGGLE ON/OFF] key is displayed only when
the cursor is positioned next to the <BAR CODE CHECK
DIGIT> entry field.

4. Press the [SET UP] key to return to the


OPERATION SET UP MENU screen.

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Operating Instructions
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Computer Set Up Soft Key

COMPUTER SET UP Dec 08 1998 16:13


Ready Operator ID smw
Sequence # 0070

1 OFF Auto-transmission of ALERTED parameter data


2 OFF Auto-transmission of NON-ALERTED parameter data
3 OFF Auto-transmission of ALERTED graph data
4 OFF Auto-transmission of NON-ALERTED graph data
5 OFF Transmission CTS enabled
8 Transmission Data bits (7, 8)
1 Transmission Stop bits (1, 2)
0 Transmission Parity (0=None, 1=Odd, 2=Even)
0.3 Transmission time out (0.1 to 9.9)
9600 Computer Baud Rate (300, 600, 1200, 2400, 4800, 9600)

REINIT STOP TOGGLE SET UP


INTERFACE TRANSMISS ON/OFF

Figure 5.19: Computer Set Up Screen

COMPUTER The [COMPUTER SET UP] key on the OPERATION SET UP MENU screen
SET UP is used to display the COMPUTER SET UP screen (see the preceding
figure) and the following soft key labels:

REINIT INTERFACE
STOP TRANSMISS
TOGGLE ON/OFF
SET UP
The CELL-DYN 3700 System has the capability to transmit data to
an on-line computer (Laboratory Information System, or LIS).
Data can be transmitted automatically as each sample is run, or
data can be transmitted at the operator’s request. The CELL-DYN
3700 System can also receive patient information that is
transmitted to it by the on-line computer.
The COMPUTER SET UP screen is used to configure the
transmission format to meet the requirements of the LIS or on-
line computer. Instructions for using this option are given after
the following description of the soft keys.

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Reinitialize Interface Soft Key


REINIT The [REINIT INTERFACE] key on the COMPUTER SET UP screen is used
INTERFACE to initialize the RS-232 Interface for the displayed transmission
configuration after it is entered.

NOTE: Refer to the Interface Specification


(L/N 02H33-01) for complete information on interfacing.

Stop Transmiss Soft Key


STOP The [STOP TRANSMISS] key stops the current data transmission to
TRANSMISS the on-line computer. When the [STOP TRANSMISS] key is pressed,
the following soft key labels are displayed:

CONFIRM STOP
CANCEL STOP
These keys confirm or cancel the Stop Transmission command.

Toggle ON/OFF Soft Key


TOGGLE The [TOGGLE ON/OFF] key enables or disables the first five options
ON/OFF in the list displayed on the COMPUTER SET UP screen.

The numbers on the COMPUTER SET UP screen shown in the


preceding figure correspond to the following numbered options:

1. Auto-transmission of ALERTED parameter data


When this option is enabled, a report is automatically
transmitted to the LIS for any sample with flagged
parameter results.
2. Auto-transmission of NON-ALERTED parameter
data
When this option is enabled, a report is automatically
transmitted to the LIS for any sample without flagged
parameter results.
3. Auto-transmission of ALERTED graph data
When this option is enabled, histograms are automatically
transmitted to the LIS for any sample with flagged results.
4. Auto-transmission of NON-ALERTED graph data
When this option is enabled, histograms are automatically
transmitted to the LIS for any sample without flagged
results.

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5. The remaining options are configured according to the


transmission requirements of the LIS:
• Transmission CTS enabled
• Transmission Data bits (7, 8)
• Transmission Stop bits (1, 2)
• Transmission Parity (0=None, 1=Odd, 2=Even)
• Transmission time out (0.1 to 9.9)
• Computer Baud Rate (300, 600, 1200, 2400,
4800, 9600)
The numbers in parentheses after the options indicate the
selections available.
NOTE: Refer to the Interface Specification
(L/N 02H33-01) for complete information on interfacing.

Procedure: Computer Set Up


1. From the OPERATION SET UP MENU screen, press the
[COMPUTER SET UP] key to display the COMPUTER SET UP
screen.
2. For the first five options on the list, use the arrow keys on
the keyboard to move the cursor to the desired selection and
press the [TOGGLE ON/OFF] key to enable or disable the
selection.
NOTE: The [TOGGLE ON/OFF] key is displayed when the
cursor is positioned in any of the first five entry fields.

3. For the last five options on the list, type the appropriate
information and press the Enter key on the keyboard to save
the entry and advance the cursor.
4. When all the information has been entered, press the
[REINIT INTERFACE] key to initialize the interface for the
selected configuration.
5. To obtain a printout of the configuration, press the Print
Screen key on the keyboard.
6. Press the [SET UP] key to return to the OPERATION SET UP
MENU screen.
7. Press the [RETURN] key to return to the MAIN MENU screen.

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Units Selection Soft Key

UNITS SELECTION Dec 08 1998 16:16


Ready Operator ID rsj
Sequence # 0070

Parameters USA SI SI MOD SET 1 SET 2

WBC K/µL G/L 10e9/L 10e3/µL 10e2/µL


RBC M/µL T/L 10e12/L 10e6/µL 10e4/µL
HGB g/dL g/L mmol/L g/L g/dL
HCT % L/L L/L % %
RDW % %CV %CV %CV %
PLT K/µL G/L 10e9/L 10e3/µL 10e4/µL
PCT % mL/L mL/L % %

USA SI SI MOD SET 1 SET 2 SELECT RETURN


UNITS UNITS UNITS UNITS UNITS UNITS

Figure 5.20: Units Selection Screen

UNITS The [UNITS SELECTION] key on the SET UP MENU screen is used to
SELECTION display the UNITS SELECTION screen. This screen allows the
selection of the report units for the indicated parameters. Units
may be selected for each parameter individually or a set of units
may be selected by pressing the appropriate soft key. (See the
preceding figure.) The following soft key labels are displayed on
the UNITS SELECTION screen:
USA UNITS
SI UNITS
SI MOD UNITS
SET 1 UNITS
SET 2 UNITS
SELECT UNITS
RETURN

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The units selected by each of the soft keys are shown on the
screen display in the preceding figure. The following table shows
an example of the same sample displayed with each of the four
units selections. Refer to Section: Reticulocyte Package,
Subsection: Retic Units Selection Softkey for information on
reticulocyte units.
Table 5.1: Report Units

USA SI SI MOD SET 1 SET 2

Parameter Value Units Value Units Value Units Value Units Value Units

WBC* 5.32 K/µL 5.32 G/L 5.32 10e9/L 5.32 10e3/µL 53.2 10e2/µL

RBC 5.15 M/µL 5.15 T/L 5.15 10e12/L 5.15 10e6/µL 515. 10e4/µL

HGB 16.2 g/dL 162 g/L 10.1 mmol/L 162 g/L 16.2 g/dL

HCT 47.6 % 0.476 L/L 0.476 L/L 47.6 % 47.6 %

MCV 92.3 fL 92.3 fL 92.3 fL 92.3 fL 92.3 fL

MCH 31.5 pg 31.5 pg 1.96 fmol 31.5 pg 31.5 pg

MCHC 34.1 g/dL 341 g/L 21.2 mmol/L 341 g/L 34.1 g/dL

RDW 12.5 % 12.5 %CV 12.5 %CV 12.5 %CV 12.5 %

PLT 323 K/µL 323 G/L 323 10e9/L 323 10e3/µL 32.3 10e4/µL

MPV 8.26 fL 8.26 fL 8.26 fL 8.26 fL 8.26 fL

PCT*** 0.267 % 2.67 mL/L 2.67 mL/L 0.267 % 0.267 %

PDW**, *** 17.5 10GSD 17.5 10GSD 17.5 10GSD 17.5 10GSD 17.5 10GSD

*NEU, LYM, MONO, EOS, and BASO are reported in the same units as the WBC.
**Report Unit is Geometric Standard Deviation.
***Clinical significance has not been established for these parameters. Therefore, they are not
reportable in the US.

Procedure: Units Selection


1. From the SET UP MENU screen, press the [UNITS SELECTION]
key.
2. Choose one of the following options:
• Press the appropriate soft key to select the desired units.
The group of selected units is highlighted on the screen.
• For individual unit selection, use the arrow keys on the
keyboard to move the cursor to the desired units.
3. Press the [SELECT UNITS] key to enter the selection. The
chosen selection is highlighted on the display.
4. Use the arrow keys on the keyboard to move the cursor to
the next unit to be selected.
5. Repeat steps 3 and 4 until all selections have been made.

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6. To obtain a printout of the selected units, press the Print


Screen key on the keyboard.
7. Press the [RETURN] key to return to the SET UP MENU screen.

Customize Report Soft Key


CUSTOMIZE The [CUSTOMIZE REPORT] key on the SET UP MENU screen is used to
REPORT customize the displayed and printed reports. From this screen,
the parameters and graphs to be displayed on reports can be
selected, the header can be customized, and the type of printout
can be selected.
When the [CUSTOMIZE REPORT] key is pressed, one of three
possible screens will be displayed (whichever one was used last).
The three possible screens are the CUSTOMIZE DISPLAYED REPORT
screen, the CUSTOMIZE PRINTED REPORT screen, and the CUSTOMIZE
PRINTOUT HEADER screen. (See the following flowchart.)

SET UP MENU
Ready

CUSTOMIZE
REPORT

CUSTOMIZE DISPLAYED REPORT CUSTOMIZE PRINTOUT HEADER


Ready Ready

PARAM PARAM PARAM PARAM CUSTOMIZE CUSTOMIZE SELECT SET UP RESTORE BLANK CUSTOMIZE CUSTOMIZE SET UP
SET 1 SET 2 SET 3 SET 4 PRINTOUT HEADER GRAPH HEADER HEADER DISPLAY PRINTOUT

PARAM PARAM PARAM PLACE SET UP CUSTOMIZE PRINTED REPORT


PARAM CUSTOMIZE CANCEL
SET 1 SET 2 SET 3 SET 4 PRINTOUT GRAPH GRAPH Ready

TICKET CUSTOMIZE STOP CUSTOMIZE TOGGLE SET UP


PRINTER DISPLAY PRINTING HEADER ON/OFF
RESTORE PRE-PRNTD GRAPHICS
HEADER TICKET PRINTER
BLANK CONFIRM CANCEL
TICKET STOP STOP

Each one of these three possible screens displays two of the


following three soft key labels:
CUSTOMIZE DISPLAY
CUSTOMIZE PRINTOUT
CUSTOMIZE HEADER
Each of these three screens is explained individually on the
following pages.
NOTE: The [CUSTOMIZE REPORT] key can also be accessed
from the RUN screen and the DISPLAY SPECIMEN screen in
the Data Log.

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Customize Displayed Report

CUSTOMIZE DISPLAYED REPORT Dec 21 1998 16:57


Ready Operator ID SH
PARAMETER SET 1 SELECTED Sequence # 0630

ON WBC Size-Cmp (0-10)


ON NEU ON %N Grn-Lob (90D-90)
ON LYM ON %L 10 deg-90 deg
ON MONO ON %M 0 deg-90 deg
ON EOS ON %E 10 deg-90 deg D
ON BASO ON %B 0 deg-90 deg D

ON RBC N-L-M Histogram Size-Cmp (0-10) Grn-Lob (90D-90)


ON HGB M-P Histogram
ON HCT
ON MCV RBC Histogram
ON MCH PLT Histogram
ON MCHC WIC Histogram
ON RDW Empty

ON PLT
ON MPV RBC Histogram PLT Histogram

Auto-Sampler Busy
PARAM PARAM PARAM CUSTOMIZE CUSTOMIZE SELECT SET UP
SET 2 SET 3 SET 4 PRINTOUT HEADER GRAPH

Figure 5.21: Customize Displayed Report Screen

CUSTOMIZE The CUSTOMIZE DISPLAYED REPORT screen (see the preceding


DISPLAY figure) for the indicated parameter set will be displayed when the
[CUSTOMIZE DISPLAY] key is pressed. The following soft key labels
are displayed on the CUSTOMIZE DISPLAYED REPORT screen:
PARAM SET 1*
PARAM SET 2*
PARAM SET 3*
PARAM SET 4*
CUSTOMIZE PRINTOUT
CUSTOMIZE HEADER or
CANCEL GRAPH (This key label alternates between
these two selections when the
[SELECT GRAPH] key is pressed.)
SELECT GRAPH or
PLACE GRAPH or
TOGGLE PARAMETER (This key label alternates between
these three selections when the soft
key is pressed.)
SET UP
*The soft key label for the parameter set currently displayed
on the screen is not shown.

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Using the [PARAM SET “X”] key, the display can be customized for
PARAM
SET “X” four different sets of parameters. Up to 20 individual parameters
and up to four scatterplots and/or histograms can be displayed in
each set. (The “empty” selection may be used to “blank” the
scatterplot or histogram display at the selected position.)
Individual parameters are listed in the left portion of the screen,
and the scatterplots and histograms are listed in the right portion.

Procedure: Customize Display


1. From the SET UP MENU screen, press the [CUSTOMIZE REPORT]
key and if necessary, press the [CUSTOMIZE DISPLAY] key to
display a parameter set.
2. If desired, press the [PARAM SET “X”] key to select a different
parameter set.
3. Use the arrow keys on the keyboard to move the cursor to
the desired parameter in the list displayed in the left portion
of the screen.
4. Press the [TOGGLE PARAMETER] key to turn the display OFF
or ON and advance the cursor to the next parameter. The
cursor moves through the entire list of parameters in this
portion of the screen and, when at the bottom, returns to
the top of this list.
NOTE: The [TOGGLE PARAMETER] key is displayed only
when the cursor is positioned in the list of individual
parameters displayed in this portion of the screen.

5. When all parameter selections have been made, move the


cursor to the top of the parameter list and use the arrow
keys on the keyboard to move the cursor to the desired
scatterplot or histogram listed on the left side of this portion
of the screen.
6. Press the [SELECT GRAPH] key to select it. The scatterplot or
histogram name is highlighted and the cursor moves to a
display position. The key label changes to [PLACE GRAPH]
and the [CANCEL GRAPH] key is displayed.
7. If necessary, use the arrow keys on the keyboard to move
the cursor to the desired display position.
8. Press the [PLACE GRAPH] key to display the selection at the
indicated position.
9. The cursor moves through the entire list of scatterplots and
histograms. Repeat steps 3–8 until all selections have been
made for the current Parameter Set.

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10. To obtain a printout of the selected Parameter Set, press the


Print Screen key on the keyboard.
11. To select another Parameter set, press the [PARAM SET “X”]
key. To customize the display for it, repeat steps 3–10.
12. Press the [SET UP] key to return to the SET UP MENU screen.

Customize Printed Report


CUSTOMIZE The CUSTOMIZE PRINTED REPORT screen will be displayed when
PRINTOUT the [CUSTOMIZE PRINTOUT] key is pressed. This screen is used to
customize the printout for the Graphics Printer or the Ticket
Printer. The following soft key labels are displayed when the
[CUSTOMIZE PRINTOUT] key is pressed:

GRAPHICS PRINTER or
TICKET PRINTER (This key label alternates
between these two selections
when the soft key is pressed.)
CUSTOMIZE DISPLAY
STOP PRINTING
CUSTOMIZE HEADER
TOGGLE ON/OFF
SET UP
When the [TICKET PRINTER] key is pressed, the key label changes
to [GRAPHICS PRINTER] and the following soft key labels are also
displayed:
BLANK TICKET or
PRE-PRNTD TICKET (This key label alternates
between these two selections when the
soft key is pressed.)
RESTORE HEADER (This key label appears only when the
[BLANK TICKET] key is selected.)
When the [CUSTOMIZE PRINTOUT] key is pressed, the screen that
was used for the last entry is displayed. A brief description of the
function of the soft keys is given in this section. For ease of
explanation, the keys are grouped according to the type of printer
selected. This section contains the following subsections:
• General Purpose Soft Keys
• Ticket Printer Soft Keys
• Graphics Printer Soft Keys

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General Purpose Soft Keys


CUSTOMIZE The [CUSTOMIZE DISPLAY] key is used to switch to the
DISPLAY CUSTOMIZE DISPLAYED REPORT screen (discussed in the preceding
section).

STOP The [STOP PRINTING] key is used to stop printing that is in


PRINTING progress. When the [STOP PRINTING] key is pressed, the following
soft key labels are displayed:

CONFIRM STOP
CANCEL STOP
These keys confirm or cancel the Stop Printing command. If the
[CONFIRM STOP] key is pressed, the print buffer (the memory area
where the material is stored while awaiting printing) is cleared
and the bulletin line displays the following message: PRINTING
STOPPED. RESET PAPER TO THE TOP OF THE PAGE.

CUSTOMIZE The [CUSTOMIZE HEADER] key is used to move to the CUSTOMIZE


HEADER PRINTOUT HEADER screen (discussed in the following section).

TOGGLE The [TOGGLE ON/OFF] key enables or disables the option selected
ON/OFF by the position of the cursor. The key label is not displayed when
a numeric entry is required.

SET UP The [SET UP] key is used to return to the SET UP MENU screen.

Ticket Printer Soft Keys


TICKET Two options are available when the [TICKET PRINTER] key is pressed:
PRINTER

BLANK TICKET or
PRE-PRNTD TICKET (This key label alternates between
these two selections when the soft
key is pressed.)
BLANK
TICKET The [PRE-PRNTD TICKET] key is used to customize the printed
PRE-PRINTD report for a preprinted ticket. The [BLANK TICKET] key is used to
TICKET
customize the printed report for a blank ticket.

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Pre-Printed Ticket Soft Key

CUSTOMIZE PRINTED REPORT Dec 18 1998 08:58


Ready Operator ID sh
Sequence # 0630

1 OFF TICKET PRINTER - PRE-PRINTED TICKET

2 OFF AUTO-PRINT results for ALERTED specimens


3 OFF AUTO-PRINT results for NON-ALERTED specimens
4 OFF Print PCT, PDW results

BLANK GRAPHICS CUSTOMIZE STOP CUSTOMIZE TOGGLE SET UP


TICKET PRINTER DISPLAY PRINTING HEADER ON/OFF

Figure 5.22: Customize Printed Report Screen for Pre-Printed Tickets

PRE-PRINTD The [PRE-PRNTD TICKET] key is used to display the CUSTOMIZE


TICKET
PRINTED REPORT screen for preprinted tickets. The numbers on
the screen shown in the preceding figure correspond to the
following numbered options:

1. TICKET PRINTER — PRE-PRINTED TICKET


When this option is enabled, the Ticket Printer is configured
for a preprinted ticket. (The blank ticket option is
automatically turned OFF.)
2. AUTO-PRINT results for ALERTED specimens
When this option is enabled, results for flagged specimens
are automatically printed as tickets are inserted in the
printer. Flagged results are marked with an asterisk (*).
3. AUTO-PRINT results for NON-ALERTED specimens
When this option is enabled, results for specimens that are
not flagged are automatically printed as tickets are inserted
in the printer.

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4. Print PCT, PDW results


When this option is enabled, the PCT and PDW are printed
on the ticket.
NOTE: Clinical significance has not been established for
these parameters. Therefore, they are not reportable.

Procedure: Customize Pre-Printed Ticket


1. From the CUSTOMIZE PRINTED REPORT screen, if necessary,
press the [PRE-PRNTD TICKET] key to display the
CUSTOMIZE PRINTED REPORT screen for the Ticket Printer
using preprinted tickets.
2. Use the arrow keys on the keyboard to move the cursor to
the desired option.
3. Press the [TOGGLE ON/OFF] key to enable or disable the
selected option.
4. Repeat steps 2 and 3 until all selections have been made.
5. To obtain a printout of the selections, press the Print Screen
key on the keyboard.
6. Press the [SET UP] key to return to the SET UP MENU screen.
NOTE: When the preprinted ticket is selected the blank
ticket is automatically turned off, and vice versa. Both
cannot be on at the same time.

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Blank Ticket Soft Key

CUSTOMIZE PRINTED REPORT Dec 18 1998 08:57


Ready Operator ID sh
Sequence # 0630

1 ON TICKET PRINTER - BLANK TICKET

2 OFF AUTO-PRINT results for ALERTED specimens


3 OFF AUTO-PRINT results for NON-ALERTED specimens
4 OFF Print PCT, PDW results
5 OFF Print Limits Report
6 OFF Print Specific Alerts
7 OFF Print Manual Differential Grid for ALERTED specimens
8 OFF Print Manual Differential Grid for NON-ALERTED specimens
9 68 Line-feeds per page for ticket printer (1 to 99)
10 2 Number of lines for the customize ticket header (0 to 2)
. . . . . . . . . 1 . . . . . . . . . .2 . . . . . . . . . . 3. . . . . . . . . . . . .

RESTORE PRE-PRNTD GRAPHICS CUSTOMIZE STOP CUSTOMIZE TOGGLE SET UP


HEADER TICKET PRINTER DISPLAY PRINTING HEADER ON/OFF

Figure 5.23: Customize Printed Report Screen for Blank Tickets

BLANK The [BLANK TICKET] key is used to display the


TICKET CUSTOMIZE PRINTED REPORT screen for blank tickets. The numbers
on the screen shown in the preceding figure correspond to the
following numbered options:

1. TICKET PRINTER — BLANK TICKET


When this option is enabled, the Ticket Printer is configured
for a blank ticket. (The preprinted ticket option is
automatically turned OFF.)
2. AUTO-PRINT results for ALERTED specimens
When this option is enabled, a ticket is automatically
printed for any sample with flagged results. Flagged results
are indicated by the letters “AL” (for alert) on the printout
when the Print Specific Alerts option is turned OFF (see
number 6 below). Results that fall outside of Patient Limits
are underlined on the printout.
3. AUTO-PRINT results for NON-ALERTED specimens
When this option is enabled, a report is automatically
printed for any sample without flagged results.

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4. Print PCT, PDW Results


When this option is enabled, the results for PCT and PDW
are printed on the report.
NOTE: Clinical significance has not been established for
these parameters. Therefore, they are not reportable.

5. Print Limits Report


When this option is enabled, the Patient Limits Set that was
applied to the results is printed on the report.
6. Print Specific Alerts
When this option is enabled, the specific flag (BAND, LRI,
etc.) replaces the “AL” on the printout.
7. Print Manual Differential Grid for ALERTED
specimens
When this option is enabled, a grid that can be used to
report a manual differential is printed on the report for any
specimen that is flagged.
8. Print Manual Differential Grid for NON-
ALERTED specimens
When this option is enabled, a grid that can be used to
report a manual differential is printed on the report for any
specimen that is not flagged.
9. Line-feeds per page for ticket printer
(1 to 99)
This option is used to select the size of the printed report.
(A blank ticket typically has 68 lines.)
10. Number of lines for the customize ticket
header (0 to 2)
This option is used to select the number of lines for the
header on the blank ticket. The numbers across the top of
the header can be used to center the header information on
the ticket. Centering the information under the number 2
centers it on the ticket.

Procedure: Customize Blank Ticket


1. From the CUSTOMIZE PRINTED REPORT screen, if necessary,
press the [BLANK TICKET] key or the [TICKET PRINTER] key to
display the CUSTOMIZE PRINTED REPORT screen for the blank
tickets.

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2. Use the arrow keys on the keyboard to move the cursor to


the desired selection.
3. Press the [TOGGLE ON/OFF] key to enable or disable the
selection.
4. Repeat steps 2 and 3 until all selections have been made.
5. A numeric entry is required for the <Line-feeds per page for
ticket printer> entry field (a blank ticket typically has 68 lines)
and for the <Number of lines for the customize ticket header>
entry field.
6. Type the desired number of line-feeds in the entry field and
press the Enter key on the keyboard to save the entry and
advance the cursor.
7. Type the desired number of lines for the header and press
the Enter key on the keyboard to save the entry and advance
the cursor.
8. Type the first line of the header and press the Enter key on
the keyboard to save the entry and advance the cursor. Each
line holds 35 characters. If desired, type a second line and
press the Enter key on the keyboard to save the entry and
advance the cursor.
9. To obtain a printout of the selections, press the Print Screen
key on the keyboard.
10. Press the [SET UP] key to return to the SET UP MENU screen.

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Graphics Printer Soft Keys

CUSTOMIZE PRINTED REPORT Dec 20 1998 16:58


Ready Operator ID sh
Sequence # 0630

GRAPHICS PRINTER

1 OFF AUTO-PRINT results for ALERTED specimens


2 OFF AUTO-PRINT results for NON-ALERTED specimens
3 OFF Print graphs for ALERTED specimens only
4 OFF Print PCT, PDW results
5 ON Print X-B RBC Program status
6 ON Print X-B WBC Program status
7 OFF Print Interpretive Report
8 OFF Print Limits Report
9 OFF Print Manual Differential Grid for ALERTED specimens
10 OFF Print Manual Differential Grid for NON-ALERTED specimens
11 66 Line-feeds per page for graphics printer (1 to 99)
12 OFF Color Printing

TICKET CUSTOMIZE STOP CUSTOMIZE TOGGLE SET UP


PRINTER DISPLAY PRINTING HEADER ON/OFF

Figure 5.24: Customize Printed Report Screen for the Graphics Printer

GRAPHICS The [GRAPHICS PRINTER] key is used to display the


PRINTER CUSTOMIZE PRINTED REPORT screen for the Graphics Printer. The
numbers on the CUSTOMIZE PRINTED REPORT screen shown in the
preceding figure correspond to the following numbered options:
1. AUTO-PRINT results for ALERTED specimens
When this option is enabled, a report is automatically
printed for any sample with flagged results.
2. AUTO-PRINT results for NON-ALERTED specimens
When this option is enabled, a report is automatically
printed for any sample without flagged results.
3. Print graphs for ALERTED specimens only
When this option is enabled, scatterplots and histograms are
printed only for samples with flagged results.
4. Print PCT, PDW results
When this option is enabled, the results for PCT and PDW
are printed on the report.
NOTE: Clinical significance has not been established for
these parameters. Therefore, they are not reportable.

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5. Print X-B RBC Program status


When this option is enabled, the status of the X-B RBC
program is printed on the report. The X-B RBC status (for
example, X-B RBC: 13/OUT2) is printed at the top of the
page.
6. Print X-B WBC Program status
When this option is enabled, the status of the X-B WBC
program is printed on the report. The X-B WBC status (for
example, X-B WBC: 13/OUT2) is printed at the top of the
page.
7. Print Interpretive Report
When this option is enabled, the Interpretive Report
messages are printed on the report. These messages are
generated when results exceed the Patient Limits and/or
instrument-generated flags are present. For an explanation
of the Interpretive Report messages, refer to Chapter 3:
Principles of Operation, Subsection: Operational
Messages and Data Flagging. (Also see the [PATIENT
LIMITS] key discussion earlier in this section.)
8. Print Limits Report
When this option is enabled, the Patient Limits Set that was
applied to the results is printed on the report.
9. Print Manual Differential Grid for ALERTED
specimens
When this option is enabled, a grid that can be used to
report a manual Differential is printed on the report for any
specimen that is flagged.
10. Print Manual Differential Grid for NON-
ALERTED specimens
When this option is enabled, a grid that can be used to
report a manual Differential is printed on the report for any
specimen that is not flagged.
11. Line-feeds per page for graphics printer
(1 to 99)
This option is used to select the size of the printed report.
The line-feeds should be 66 lines for 8 ½” x 11” paper.
12. Color printing
When this option is enabled, a color printout can be
obtained on the CELL-DYN 3700 System by pressing the
[COLOR PRINT] key. It is not possible to automatically obtain
color printouts.

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Procedure: Customize Graphics Report


1. From the CUSTOMIZE PRINTED REPORT screen, if necessary,
press the [GRAPHICS PRINTER] key to display the
CUSTOMIZE PRINTED REPORT screen for the Graphics Printer.
(See the preceding figure.)
2. Use the arrow keys on the keyboard to move the cursor to
the desired selection.
3. Press the [TOGGLE ON/OFF] key to enable or disable the
selection.
4. Repeat steps 2 and 3 until all selections have been made.
5. A numeric entry is required for the <LINE-FEEDS PER PAGE
FOR GRAPHICS PRINTER> entry field. Type the desired
number of line-feeds in the entry field and press the Enter
key on the keyboard to save the entry and advance the
cursor. (An 8.5" x 11" sheet of paper has 66 lines per page.)
6. To obtain a printout of the selections, press the Print Screen
key on the keyboard.
7. If desired, press the [SET UP] key to return to the
SET UP MENU screen, or continue with the following
procedure for customizing the header, Customize Printout
Header.

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Customize Printout Header

CUSTOMIZE PRINTOUT HEADER Dec 17 1998 16:58


Ready Operator ID sh
Sequence # 0630

Please enter the number of lines for the customize header (0..4) : 0
Print current Date/Time and Software Version : OFF
. . . . . . . 1. . . . . . . . 2 . . . . . . . . . 3 . . . . . . . . 4 . . . . . . . . 5 . . . . . . . . 6 . . . . . . . . 7 . . . .

RESTORE BLANK CUSTOMIZE CUSTOMIZE SET UP


HEADER HEADER DISPLAY PRINTOUT

Figure 5.25: Customize Printout Header Screen for the Graphics Report

CUSTOMIZE The CUSTOMIZE PRINTOUT HEADER screen is displayed when the


HEADER [CUSTOMIZE HEADER] key is pressed. (See the preceding figure.)
This screen is used to customize the printout header for the
graphics report. Any report printed in a graphics format will be
printed with this header. The following soft key labels are
displayed on the CUSTOMIZE PRINTOUT HEADER screen:
RESTORE HEADER
BLANK HEADER
CUSTOMIZE DISPLAY
CUSTOMIZE PRINTOUT
SET UP

BLANK The [BLANK HEADER] key is used to erase the current header.
HEADER

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The [RESTORE HEADER] key is used to restore the header to the


RESTORE
HEADER previous entry. This key is only functional immediately after a
new header has been entered. Once a new header is entered and
the CUSTOMIZE PRINTOUT HEADER screen has been exited, the
previous header is removed from the memory.

CUSTOMIZE The [CUSTOMIZE DISPLAY] key is used to switch to the


DISPLAY CUSTOMIZE DISPLAYED REPORT screen (discussed in the preceding
section).

CUSTOMIZE The [CUSTOMIZE PRINTOUT] key is used to switch to the


PRINTOUT CUSTOMIZE PRINTED REPORT screen (discussed in the preceding
section).

SET UP The [SET UP] key is used return to the SET UP MENU screen.

Procedure: Customize Graphics Header


1. From any CUSTOMIZE PRINTED REPORT screen, press the
[CUSTOMIZE HEADER] key to display the
CUSTOMIZE PRINTOUT HEADER screen.
2. Type the desired number of lines for the header in the
indicated field. The header can include up to four lines.
3. Press the Enter key on the keyboard to save the entry and
advance the cursor to the next entry field.
4. Press the [TOGGLE ON/OFF] key to enable or disable the Print
Current Date/Time and Software Version option and
advance the cursor to the next entry field.
5. Type the information to be displayed on the first line of the
header. Each line holds 77 characters. (Existing information
may be typed over, or an existing header may be deleted by
pressing the [BLANK HEADER] key.)
NOTE: The numbers displayed above the header box on
the screen indicate the position of the header on the
printed page. For example, centering the header
information under the number 4 centers the header on
the page.

6. Press the Enter key on the keyboard to save the entry and
advance the cursor to the next entry field.
7. Repeat steps 5 and 6 for each line of the header.
8. Press the [SET UP] key to return to the SET UP MENU screen.

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NOTES

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Chapter 5 Routine Operation

Routine Operation

The routine operation of the CELL-DYN 3700® System proceeds


from the RUN screen, which is accessed from the MAIN MENU
screen. (See the flowcharts at the beginning of this chapter.)
Information and procedures related to the RUN screen and the
submenus accessed from it are presented in this section. These
include the following:

• A description of the RUN menu and soft keys


• Sample analysis information and procedures
• Daily start up
• Daily QC checks
• Running samples
• Daily shutdown
• How to set up the Work List
• Sample analysis using the Work List

Some of the operating procedures differ between the CELL-DYN


3700SL System and the CELL-DYN 3700CS System. Where the two
systems are identical, as in the RUN screen, only one description is
presented. Where there are differences, as in the sample analysis
and Work List descriptions, a complete description is presented for
the CELL-DYN 3700SL System followed by a complete description
for the CELL-DYN 3700CS System.

For more detailed information about the Sample Loader and the
use of bar codes labels, refer to Chapter 12: Sample Loader and
Appendix A: Bar Codes, respectively.

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Run Menu

1 Next ID ------------ Auto RUN Dec 18 1998 09:02


2 Patient ---------------- Ready Operator ID sh
3 Sex(M/F):- DOB:--/--/-- Sequence # 0630
Dr ---------------------- XB RBC: XB WBC: WL:OFF Open Sampler
4
5 Param : 1 Limits: 1
WBC K/uL G
R
NEU %N S A
LYM %L I N
Z L
MONO %M
E R
EOS %E
T
BASO %B Y

RBC M/uL COMPLEXITY LOBULARITY


HGB g/dL
HCT %
MCV fL
MCH pg
MCHC g/dL
RDW %

PLT K/uL
MPV fL PLT RBC

CLEAR WORK SPECIMEN CUSTOMIZE CHANGE PRINT PRINT MAIN


APERTURES LIST TYPE REPORT SAMPLER TICKET REPORT

Figure 5.26: Run Screen for Patient Samples

RUN The [RUN] key on the MAIN MENU screen is used to display the RUN
screen. (See the preceding figure.) The following soft key labels
are displayed on the RUN screen:
CLEAR APERTURES or
CLEAR FAULT or
PRIME (This key label alternates between
these three selections.)
WORK LIST
SPECIMEN TYPE
CUSTOMIZE REPORT
CHANGE SAMPLER or
TOGGLE AUTO ID (This key label alternates between
these two selections.)
PRINT TICKET
PRINT REPORT or
COLOR PRINT (This key label changes to [COLOR
PRINT] when the color printing
option is selected.)
MAIN

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Chapter 5 Routine Operation

Run Screens
There are seven possible RUN screens, each customized for one of
the following different types of specimen: Patient, QC Specimen,
Background, Electrical Background, Latex, Resistant RBC, and
Auxiliary. These customized screens are accessed by pressing the
[SPECIMEN TYPE] key on each RUN screen and then choosing the
desired specimen type.

Specimen Type: Patient


The Patient RUN screen is described, as this is the one most often
used by operators. The upper left-hand corner of the RUN screen
for patient specimens displays the following data entry fields on
lines 1–5 (see the preceding figure):
1. <NEXT ID> Used to enter the ID number for the next
specimen to be run. (Up to 12 characters may be
entered). If the Auto-Increment feature is active,
AUTO is highlighted at the end of the field. Refer
to the discussion in the Sample Analysis section
for more information about this feature.
2. <PATIENT> Used to enter the patient’s name or identification.
(Up to 16 characters may be entered.)
NOTE: If the resistant RBC RUN screen is selected,
<RES RBC> will be displayed on this entry field.

3. <SEX (M/F):/DOB: --/--/--> Used to enter the sex and birth date
of the patient.
4. <DR> Used to enter the name of the patient’s
physician. (Up to 22 characters may be entered.)
XB RBC or
XB WBC: If the XB RBC and/or XB WBC
Analysis is enabled, the file
status is displayed to the right of
the <DR> entry field.
WL: The status (OFF/ON) of the Work List is
displayed after the X-B status field.
5. <PARAM:/LIMITS:> Displays the number (1–4) of the
Parameter and Limit Sets that will be
applied to the sample results.
NOTE: Both Parameter and Limit Sets may be changed
after the sample has been run. Refer to the description of
the [EDIT SPECIMEN] key given in Using the Data Log within
this chapter.

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1 Next ID ------------ RUN Dec 01 1998 09:43


2 Auxiliary---------------- Ready Operator ID 022
3 NOTE-------------- DOB:--/--/-- 4 Sequence # 547
5 Rslts Multiplied by 1.00 WL:OFF Open Sampler
6 Param: 1 Limits: 1
WBC G
R
NEU %N S A
LYM %L I N
Z L
MONO %M
E R
EOS %E
T
BASO %B Y

RBC M/uL COMPLEXITY LOBULARITY


HGB g/dL
HCT %
MCV fL
MCH pg
MCHC g/dL
RDW %

PLT K/uL
MPV fL PLT RBC

CLEAR SPECIMEN CUSTOMIZE PRINT MAIN


APERTURES TYPE REPORT REPORT

Figure 5.27: Run Screen for Auxiliary Samples

Specimen Type: Auxiliary


The upper left-hand corner of the RUN screen for the Auxiliary
specimen type displays the following data entry fields on lines
1-5. (See the preceding figure.)

1. <NEXT ID> Used to enter the ID number for the next


specimen to be run. (Up to 12 alphanumeric
characters may be entered).
2. <AUXILIARY> Indicates that the Auxiliary Specimen Type is
selected. If desired, the patient’s name may be
entered in this field. (Up to 16 alphanumeric
characters may be entered.)
3. <NOTE>* It is suggested that this field be used to identify
the parameter(s) that fell outside the linearity
limits. (Up to 7 alphanumeric characters may be
entered.)
4. <DOB: --/--/--> Used to enter the birth date of the patient.
5. <RSLTS MULTIPLIED BY>* Used to enter the dilution factor
used for the specimen run.

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6. <PARAM:/LIMITS:> Displays the number (1–4) of the


Parameter and Limit Sets that will be
applied to the sample results.
* The information in these fields is entered on the
AUXILIARY SPECIMEN TYPE screen.

Specimen Type: QC, Background, and Latex


If the QC SPECIMEN, BACKGROUND, ELECTRICL BKGND, or LATEX
screens are displayed, the following information is displayed.
(See Figures 5.34, 5.35, and 5.36.)
• Type Indicates Background, Electrical Background,
or the name of the selected QC file. The
number of runs in the QC file and total
file space is displayed to the right of the
type as in the following example: 31/120.
• Param Set: Indicates the Parameter Set applied to the
results.

Status Box
The Status Box is displayed in the top center of every RUN screen.
It contains the following information:

• Menu in use
• The Status of the Analyzer — the Ready, Not Ready and
Fault messages are displayed here
• Report or file identity for results currently displayed

The Status Box also displays status and instructive messages


during the RUN cycle, such as the following:

Aspirating
Remove specimen
Dispensing
Counting
Extended Count
Rinsing
Ready

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The top right-hand corner of the RUN screen displays the following
information:
• Current date and time
• Operator ID — identification of the current operator
• Sequence # — automatically incremented as samples are run
• Work List status — OFF/ON
• Selected sampler mode — Open Sampler or Closed Sampler
The center section of the RUN screen displays the results. A list
of the parameters and results is displayed on the left side.
Scatterplots and histograms are displayed on the right side. The
area between the parameter data and the graphic data is used to
display suspect flagging messages and count times. Examples of
the count times and some of the suspect flagging messages are
shown in the following two figures.

A detailed explanation of all flagging messages is given in


Chapter 3: Principles of Operation, Subsection: Operational
Messages and Data Flagging, Parameter Flagging Messages.

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Next ID ------------ Auto RUN Dec 21 1998 16:29


Patient ---------------- Ready Operator ID rcs
Sex(M/F):- DOB:--/--/-- Sequence # 0843
Dr ---------------------- XBRBC: 13/IN XBWBC: 4/IN WL: OFF Open Sampler
Param: 1 Limits: 1 SUSPECT
G
WBC 8.34 K/uL
R
NEU 4.97 59.6 %N S A
LYM 2.50 29.9 %L VAR LYM I N
MONO .551 6.61 %M Z L
E R
EOS .208 2.50 %E
T
BASO .114 1.36 %B DFLT (LM) Y
WCT:4.45
RBC 5.69 M/uL COMPLEXITY LOBULARITY
HGB 16.1 g/dL
HCT 49.3 %
MCV 86.7 fL
MCH 28.4 pg
MCHC 32.7 g/dL
RDW 14.1 %

PLT 360. K/uL


MPV 10.4 fL RCT:6.63 RBC PLT
Auto-Sampler Ready
CLEAR WORK SPECIMEN CUSTOMIZE CHANGE PRINT PRINT MAIN
APERTURES LIST TYPE REPORT SAMPLER TICKET REPORT

Figure 5.28: Run Screen Showing Count Times and Flagging Messages

Next ID ------------ Auto RUN Dec 21 1998 16:27


Patient ---------------- Ready Operator ID rcs
Sex(M/F):- DOB:--/--/-- Sequence # 0842
Dr ---------------------- XBRBC: 12/IN XBWBC: 3/IN WL: OFF Open Sampler
Param: 1 Limits: 1
G
WBC 7.93 K/uL
R
NEU 4.71 59.4 %N S A
LYM 2.39 30.1 %L I N
MONO .557 7.03 %M Z L
E R
EOS .178 2.25 %E
T
BASO .092 1.16 %B Y
WCT: 4.43
RBC M/uL COMPLEXITY LOBULARITY
HGB 16.1 g/dL
HCT %
MCV fL
MCH pg
MCHC g/dL
RDW % RBC CLOG

PLT K/uL RUT: 8.86


MPV fL RCT: 0.00 RBC PLT
Auto-Sampler Ready
CLEAR WORK SPECIMEN CUSTOMIZE CHANGE PRINT PRINT MAIN
APERTURES LIST TYPE REPORT SAMPLER TICKET REPORT

Figure 5.29: Run Screen Showing Flagging Messages, RBC CLOG Message, and
RBC Up Time

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Next ID ------------ Auto RUN Dec 21 1998 16:29


Patient ---------------- Ready
Report for XXX Operator ID rcs
Sex(M/F):- DOB:--/--/-- Sequence # 0843
Dr ---------------------- XBRBC: 13/IN XBWBC: 4/IN WL: OFF Open Sampler
Param: 1 Limits: 1 SUSPECT
G
WBC 8.34 K/uL
R
NEU 4.97 59.6 %N S A
LYM 2.50 29.9 %L VAR LYM I N
MONO .551 6.61 %M Z L
E R
EOS .208 2.50 %E
T
BASO .114 1.36 %B DFLT (LM) Y
WCT:4.45
RBC 5.69 M/uL COMPLEXITY LOBULARITY
HGB 16.1 g/dL
HCT 49.3 %
MCV 86.7 fL
MCH 28.4 pg
MCHC 32.7 g/dL
RDW 14.1 %

PLT 360. K/uL


MPV 10.4 fL RCT:6.63 RBC PLT
Auto-Sampler Pause
CLEAR WORK SPECIMEN CUSTOMIZE CHANGE PRINT PRINT MAIN
APERTURES LIST TYPE REPORT SAMPLER TICKET REPORT

Figure 5.30: Run Screen Showing Bulletin Line Message

Bulletin Line
The Bulletin Line is displayed immediately above the soft key
labels. Messages appear in this line to identify status or fault
conditions. An example of a Bulletin Line message (Auto-Sampler
Pause) is shown in the preceding figure.

Run Screen Soft Keys


A brief description of the function of each key displayed on the
PATIENT RUN screen is given in this section. Instructions for using
these keys to run samples and use the Work List are given later in
the Sample Analysis sections of this chapter.

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Clear Apertures/Clear Fault/Prime Soft Keys


CLEAR The [CLEAR APERTURES] key is used to initiate a special cleaning
APERTURES sequence that flushes the WIC and RBC/PLT Apertures to remove
CLEAR obstructions. The sequence takes approximately 35 seconds. When
FAULT
the [CLEAR APERTURES] key is pressed, the message CLEARING
PRIME
APERTURES is displayed in the Status Box.
The [CLEAR APERTURES] key label changes to [CLEAR FAULT]
whenever a system fault occurs (for example, Diluent Empty).
This key is used to clear the fault message and return the Analyzer
to the Ready status after corrective action has been taken.
NOTE: A message describing the fault appears in the
Bulletin Line. A list of fault conditions and corrective
action is given in Chapter 10: Troubleshooting.

When the system enters the Standby state while the RUN screen
is displayed, the [CLEAR APERTURES/CLEAR FAULT] key label will
change to the [PRIME] key label. Pressing the [PRIME] key primes
the system and brings it to the Ready state.

Work List Soft Key

Work List OFF WORK LIST Dec 18 1998 09:48


Ready Operator ID sh
Sequence # 0630

BAR CODE ON

# 4DIG SPECIMEN SPECIMEN L P DOCTOR DATE OF S RACK/


BC ID NAME BIRTH TUBE

1 1 1
--/--/--

WORK LIST BAR CODE INSERT/ DELETE PURGE WORK LIST PRINT RETURN
ON OFF DELETE ALL COMPLETED SET UP WORK LIST

Figure 5.31: Work List Screen

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The [WORK LIST] key is used to display the WORK LIST screen (see
WORK
LIST the preceding figure). The following soft key labels are displayed
on the WORK LIST screen:
WORK LIST ON or
WORK LIST OFF (This key label alternates between
these two selections.)
BAR CODE ON or
BAR CODE OFF (This key label alternates between
these two selections.)
INSERT/DELETE
DELETE ALL
PURGE COMPLETED
WORK LIST SET UP
PRINT WORK LIST
RETURN
These keys are used to create the Work List, which is used to
preassign specimen identification, display, and print criteria for
specimens that will be run. It is essentially a list of specimens
(including the preassigned information) that the operator intends
to run on the instrument. The Work List may be used with or
without bar code labels on the tubes. The functions of the Work
List keys are described in Routine Operation, Using the Work List
within this chapter.

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Specimen Type Soft Key

SPECIMEN TYPE Dec 20 1998 09:55


Ready Operator ID sh
Sequence # 0630

File Name # Specimens File Name # Specimens

1. Low 11 11. Patient 30


2. Normal 13 12. File 12 0
3. High 0 13. FILE 13 0
4. low 0 14. FILE 14 0
5. normal 0 15. FILE 15 0
6. high 0 16. FILE 16 0
7. Replicate 0 17. FILE 17 0
8. FILE 8 0 18. LOW 11 0
9. FILE 9 0 19. NORMAL 11 0
10. FILE 10 0 20. HIGH 11 0

Press QC SPECIMEN key to select QC FILE at cursor position.

PATIENT QC BACK- ELECTRICL LATEX RESISTANT AUXILIARY RETURN


SPECIMEN GROUND BACKGRND RBC

Figure 5.32: Specimen Type Screen

SPECIMEN The [SPECIMEN TYPE] key on the RUN screen is used to select the
TYPE type of specimen that will be run. (See the preceding figure.)
When the [SPECIMEN TYPE] key is pressed, the screen displays a
list of the QC files and the following soft key labels:

PATIENT
QC SPECIMEN
BACKGROUND
ELECTRICL BACKGRND
LATEX
RESISTANT RBC
AUXILIARY
RETURN
The function of each key is discussed in the following section.

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Routine Operation Chapter 5

Patient Soft Key

Next ID ------------ Auto RUN Dec 21 1998 16:30


Ready
Patient ---------------- Operator ID sh
Sex(M/F):-DOB:--/--/-- Sequence # 0630
Dr ---------------------- XBRBC: 13/IN XBWBC: 4/IN WL: OFF Closed Sampler
Param: 1 Limits: 1
G
WBC K/uL
R
NEU %N S A
LYM %L I N
MONO %M Z L
E R
EOS %E
T
BASO %B Y
WCT:
RBC M/uL COMPLEXITY LOBULARITY
HGB g/dL
HCT %
MCV fL
MCH pg
MCHC g/dL
RDW %

PLT K/uL RCT:


MPV fL PLT RBC
Auto-Sampler Ready
CLEAR WORK SPECIMEN CUSTOMIZE CHANGE PRINT PRINT MAIN
APERTURES LIST TYPE REPORT SAMPLER TICKET REPORT

Figure 5.33: Run Screen for Patient Samples

PATIENT The [PATIENT] key on the SPECIMEN TYPE screen is used to display
the RUN screen for patient samples. (See the preceding figure.)
Patient identification and demographics may be entered on the
RUN screen after this key is pressed. Results from this run option
are stored in the Data Log.

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QC Specimen Soft Key

RUN Dec 18 1998 09:52


Type Low 11/120 Ready Operator ID sh
Param Set: 1 Sequence # 0630
WL:OFF Open Sampler

G
WBC K/uL R
NEU %N S A
LYM %L I N
Z L
MONO %M
E R
EOS %E T
BASO %B Y
WCT:
RBC M/uL COMPLEXITY LOBULARITY
HGB g/dL
HCT %
MCV fL
MCH pg
MCHC g/dL
RDW %

PLT K/uL
MPV fL RCT: PLT RBC

CLEAR WORK SPECIMEN CUSTOMIZE CHANGE PRINT PRINT MAIN


APERTURES LIST TYPE REPORT SAMPLER TICKET REPORT

Figure 5.34: Run Screen for a QC File

QC The [QC SPECIMEN] key on the SPECIMEN TYPE screen is used


SPECIMEN to select a QC file designated by the position of the cursor on
the screen. After the cursor is moved to the desired file, the
[QC SPECIMEN] key is pressed to display the RUN screen for the
selected file. (See the preceding figure.) Results from this run
option are stored in the selected file and in the Data Log.

NOTE: The selected QC file is identified on the same line


as the <Patient> entry field. It will also be identified in the
Status Box after the specimen has been run.

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Background Soft Key

RUN Dec 18 1998 09:52


Type BACKGROUND Ready Operator ID sh
Param Set: 1 Sequence # 0630
WL:OFF Open Sampler

G
WBC K/uL R
NEU %N S A
LYM %L I N
Z L
MONO %M
E R
EOS %E T
BASO %B Y
WCT:
RBC M/uL COMPLEXITY LOBULARITY
HGB g/dL
HCT %
MCV fL
MCH pg
MCHC g/dL
RDW %

PLT K/uL
MPV fL RCT: PLT RBC

CLEAR WORK SPECIMEN CUSTOMIZE CHANGE PRINT PRINT MAIN


APERTURES LIST TYPE REPORT SAMPLER TICKET REPORT

Figure 5.35: Run Screen for Background Counts

BACK- The [BACKGROUND] key on the SPECIMEN TYPE screen is used to


GROUND display the RUN screen for background counts. (See the preceding
figure.) Results from this run option are identified by the
designation BACKGROUND in the Data Log and are automatically
excluded from the X-B Analysis.

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Electrical Background Soft Key

RUN Dec 18 1998 09:52


Type ELEC BKGND Ready Operator ID sh
Param Set: 1 Sequence # 0630
WL:OFF Open Sampler

G
WBC K/uL R
NEU %N S A
LYM %L I N
Z L
MONO %M
E R
EOS %E T
BASO %B Y
WCT:
RBC M/uL COMPLEXITY LOBULARITY
HGB g/dL
HCT %
MCV fL
MCH pg
MCHC g/dL
RDW %

PLT K/uL
MPV fL RCT: PLT RBC

CLEAR WORK SPECIMEN CUSTOMIZE CHANGE PRINT PRINT MAIN


APERTURES LIST TYPE REPORT SAMPLER TICKET REPORT

Figure 5.36: Run Screen for Electrical Background Counts

ELECTRICL The [ELECTRICL BACKGRND] key on the SPECIMEN TYPE screen is


BACKGRND used to select the run mode for electrical background counts. (See
the preceding figure.) Electrical backgrounds are used to check for
electrical interference in the system. (Aperture current is turned
OFF during this cycle.) Results from this run option are identified
by the designation ELEC BKGND in the Data Log and are
automatically excluded from the X-B Analysis.

Latex Soft Key


LATEX The [LATEX] key is used to select the Run mode for polystyrene
microspheres. This key is used by Abbott service personnel. (No
screen shown.)

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Resistant RBC Soft Key

Next ID _ _ _ _ _ _ _ _ Auto RUN Dec 01 1998 09:52


ResRBC Ready Operator ID 022
Sex (M/F): _ DOB: - -/- -/- - Sequence # 547
Dr: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ XBRBC: 1/IN XBWBC: 0/IN WL:OFF Open Sampler
Param : 1 Limits: 1
G
WBC R
NEU %N S A
LYM %L I N
Z L
MONO %M
E R
EOS %E T
BASO %B Y

RBC M/uL COMPLEXITY LOBULARITY


HGB g/dL
HCT %
MCV fL
MCH pg
MCHC g/dL
RDW %

PLT K/uL
MPV fL PLT RBC

CLEAR WORK SPECIMEN CUSTOMIZE CHANGE PRINT PRINT MAIN


APERTURES LIST TYPE REPORT SAMPLER TICKET REPORT

Figure 5.37: Run Screen for Resistant RBC Specimen Type

RESISTANT The [RESISTANT RBC] key is used to select the Resistant RBC mode.
RBC This mode is used to process specimens containing RBCs that are
lyse resistant. The sample is held in the WOC Mixing Chamber for
approximately 15 seconds longer than the normal mixing time. The
extra time enhances the osmotic lysing effect of the Sheath
Reagent and reduces interference from the lyse-resistant RBCs.
(The interference caused by these RBCs frequently generates WBC
and Differential flags. The Resistant RBC cycle reduces the
number of WBC and Differential flags generated.)
This key is available only when the Open Mode is selected.

Procedure: Resistant RBC


1. If necessary, from the RUN screen, press the
[CHANGE SAMPLER] key to select the Open Mode.
2. Press the [SPECIMEN TYPE] key followed by the
[RESISTANT RBC] key to select the Resistant RBC cycle.
3. Enter the appropriate patient ID information on the line
labeled <RES RBC:>.
4. Run the sample in the Open Mode.
5. When the cycle is complete, press the [SPECIMEN TYPE] key
followed by the [PATIENT] key to return to the normal run
cycle.

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Auxiliary Soft Key


AUXILIARY The [AUXILIARY] key on the SPECIMEN TYPE screen is used to select
the Auxiliary Specimen Type, which allows the operator to run a
diluted specimen. This Specimen Type is used to process samples
that exceed the instrument linearity limit and require dilution.
The Auxiliary Specimen Type allows the operator to enter the
dilution factor and will automatically calculate the result based on
the dilution factor that was entered.
NOTE: The [AUXILIARY] key is available only in the Open
Mode with the Work List turned OFF.

AUXILIARY SPECIMEN TYPE Dec 18 1998 09:42


Ready Operator ID 123
Sequence # 3185

Note: WBC

Diluted sample results multiplied by: 3.00 (1.00 to 99.99)

Warning, during processing in this mode, Sample Sensor checks


are not performed for: Incomplete Aspiration.

Press CONFIRM SPECIMEN to select entries and enter Run Menu.


Press CANCEL SPECIMEN to cancel entries and return to the Specimen Menu.

CONFIRM CANCEL
SPECIMEN SPECIMEN

Figure 5.38: Auxiliary Specimen Type Screen

Procedure: Auxiliary
1. Dilute the specimen with Diluent according to your
laboratory’s procedure.
2. If necessary, from the RUN screen press the
[CHANGE SAMPLER] key to select the Open Mode.
3. Press the [SPECIMEN TYPE] key followed by the [AUXILIARY]
key to select the Auxiliary Specimen Type.

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4. The AUXILIARY SPECIMEN TYPE screen is displayed (see the


preceding figure), and the cursor is positioned in the <NOTE>
entry field, which can hold up to 7 characters. It is suggested
that this field be used to identify the parameter(s) that
exceeded the linearity limits.
5. Press Enter on the keyboard to advance the cursor to the
<DILUTION> entry field (the line that reads Diluted
sample results multiplied by:).
6. Type the desired dilution factor. (For example, type “3” for a
1:3 dilution, etc.) Press Enter to save the entry.
NOTE: Exercise caution when evaluating HGB results that
have been diluted by ratios greater than 1:4.

7. Press the [CONFIRM SPECIMEN] key to save the entries and


display the RUN screen for the Auxiliary Specimen Type.
(See the following figure.)
8. The dilution factor and the information entered in the
<NOTE> entry field on the previous screen are displayed in
the upper left-hand corner of the Auxiliary RUN screen.
Confirm that these entries were made correctly.
9. Enter the appropriate Patient ID number in the <Next ID>
entry field.
10. If desired, the patient name may be entered in the <Auxiliary>
entry field.
11. Run the diluted specimen in the Open Mode.
12. When the cycle is complete, the instrument automatically
exits from Auxiliary and returns to the patient RUN screen.
13. The corrected results for all parameters (results that have
been multiplied by the dilution factor) are displayed.
NOTE: If chevrons (>>>>) are displayed for the parameter
that exceeded the linearity, further dilution is required
because the result, before it is multiplied by the dilution
factor, still exceeds the linearity.

NOTE: Always compare the results and flags displayed in


Auxiliary to those obtained in the Patient Run Mode and
evaluate the individual flags displayed in both modes as
described in Chapter 3: Principles of Operation,
Subsection: Operational Messages and Data Flagging.

14. To run another dilution, repeat steps 1-13.

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Next ID RUN Dec 18 1998 09:52


Auxiliary Ready Operator ID sh
Note DOB: Sequence # 0630
Rslts Multiplied by 3.00 WL:OFF Open Sampler
Param: Limits:
G
WBC K/uL R
NEU %N S A
LYM %L I N
Z L
MONO %M
E R
EOS %E T
BASO %B Y
WCT:
RBC M/uL COMPLEXITY LOBULARITY
HGB g/dL
HCT %
MCV fL
MCH pg
MCHC g/dL
RDW %

PLT K/uL
MPV fL RCT: PLT RBC

CLEAR SPECIMEN CUSTOMIZE PRINT MAIN


APERTURES TYPE REPORT REPORT

Figure 5.39: Run Screen for the Auxiliary Specimen Type

Customize Report Soft Key


CUSTOMIZE The [CUSTOMIZE REPORT] key on the RUN screen is discussed earlier
REPORT in this chapter, in Set Up Instructions, Customize Report Soft Key.

Change Sampler Soft Key


CHANGE The [CHANGE SAMPLER] key on the RUN screen is used to select the
SAMPLER Open or Closed Mode of operation. When the key is pressed, the
mode changes from the one currently selected to the other
operating mode. The Status Box displays the message
SELECTING OPEN MODE or SELECTING CLOSED MODE.

When the cursor is positioned on the word AUTO (at the end of
the <NEXT ID> entry field), this key label changes to
[TOGGLE AUTO ID] and the auto increment feature is enabled (the
word AUTO is highlighted) or disabled. Refer to the Sample
Analysis section of this chapter for a discussion of the auto
increment feature.

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Print Ticket Soft Key


PRINT The [PRINT TICKET] key on the RUN screen is used to print a report
TICKET on a ticket when the Ticket Printer is connected to the Data
Station. The report is printed on the type of ticket that is selected
from the CUSTOMIZE PRINTED REPORT screen (discussed in Set Up
Instructions within this chapter).

Print Report Soft Key


PRINT The [PRINT REPORT] key on the RUN screen is used to print a
REPORT graphics report when the Graphics Printer is connected to the Data
COLOR Station. When the Color Graphics Printer is connected to the Data
PRINT
Station and the color printing option (on the
CUSTOMIZE PRINTED REPORT screen) is ON, the key label changes
to [COLOR PRINT]. (The CUSTOMIZE PRINTED REPORT screen is
discussed earlier in this chapter, in Set Up Instructions, Customize
Report Soft Key.) A color graphics report is printed when the
[COLOR PRINT] key is pressed.

Main Soft Key


MAIN The [MAIN] key is used to return to the MAIN MENU screen.

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Sample Collection and Handling


Anticoagulant
All performance claims given in this manual were generated from
specimens collected in K3EDTA anticoagulant. Specimens collected
in Heparin or Sodium Citrate may be run with no adverse effect
on the instrument. Certain results can be affected by the use of
these anticoagulants. Therefore, each laboratory should develop
protocols for handling specimens collected in these
anticoagulants.

Specimen Stability
Fresh whole blood specimens are recommended. The International
Committee for Standardization in Haematology (ICSH) defines a
fresh blood specimen as one processed within four hours after
collection.1
The hemogram parameters —RBC, HGB, HCT, MCV, MCH, MCHC,
RDW, PLT, and MPV— are stable (±5%) for up to 24 hours after
collection. The total WBC is stable (±5%) for up to 12 hours after
collection. The stability of the total WBC decreases to ±7% at
24 hours after collection.
The WBC Differential parameters — NEU, LYM, MONO, EOS, and
BASO — are stable (±10%) for up to 12 hours after collection. An
increase in false positive Suspect Population Flags may be seen on
samples processed less than 30 minutes after collection time or
more than 4 hours after collection time.
Stability studies conducted at Abbott indicate that specimens
exhibit increased stability when they are stored at room
temperature rather than in a refrigerator.
The stability of capillary specimens collected in microtainers may
vary depending on the microtainer manufacturer. Refer to the
manufacturer’s package insert for stability claims.

NOTE: Reticulocyte stability is discussed in Chapter 14:


Reticulocyte Package.

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Specimen Collection
All specimens should be collected using proper technique and
following the tube manufacturer’s recommendations.
NOTE: For additional information on collecting venous
and capillary specimens, refer to CLSI/NCCLS Standards,
H3-A52 and H4-A5.3

Specimens that will be run on the Sample Loader must be collected in


13 x 75-mm tubes. The recommended tube is a 13 x 75-mm tube with
a HEMOGARD closure that draws 1–3 mL of blood. The specimen
volume in this tube ensures proper mixing by the Sample Loader.
A minimum of 180 µL should be collected for capillary
specimens. This ensures an adequate amount of blood for the
Open Mode aspiration (130 µL).

WARNING: Potential Biohazard. Consider all


specimens, controls, calibrators, surfaces, or
components that contain or have contacted blood,
serum, or other bodily fluid as potentially
infectious. Wear gloves, a lab coat, and protective
eyewear, and follow other biosafety practices as
specified in the OSHA Bloodborne Pathogen Rule
(29 CFR Part 1910.1030) or other equivalent
biosafety procedures.

Interfering Substances
It is important to note that there are commonly occurring
interfering substances that can affect the results reported by
hematology analyzers. While the CELL-DYN 3700 has been
designed to detect and flag many of these substances, it may not
always be possible to do so. The following indicates the substances
that may interfere with each of the listed parameters.
WBC: Fragile WBCs, neutrophil aggregates, lytic-resistant
RBCs, NRBCs, PLT clumps, cryofibrinogen,
cryoglobulin, paraproteins
RBC: Elevated WBC count, increased numbers of giant
PLTS, auto-agglutination, in vitro hemolysis
HGB: Elevated WBC count, increased plasma substances
(triglycerides, bilirubin, in vivo hemolysis), lytic-
resistant RBCs.
MCV: elevated WBC count, hyperglycemia, in vitro
hemolysis, increased numbers of giant PLTs.

PLT: WBC fragments, in vitro hemolysis, microcytic


RBCs, cryofibrinogen, cryoglobulins, PLT clumping,
increased numbers of giant PLTs.
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Retics: Leukocyte fragments, Howell-Jolly bodies, Heinz


bodies, Pappenheimer bodies, basophilic stippling,
abnormal RBCs, NRBCs > 200/100 WBC,
autoagglutinins, cold agglutinins, platelet clumps,
paraproteins, malaria, and babesiosis.
For additional information on interfering substances, refer to the
table provided in Appendix C.
For a detailed description of the flags that are generated, refer to
Chapter 3: Principles of Operation, Subsection: Operational
Messages and Data Flagging.

Sample Analysis
Certain general guidelines should be followed when running
samples on either the Sample Loader or the Closed Sampler
instruments.
• Samples should not be run until the instrument has been
properly started up and daily QC checks have been
performed.
• The Ready message must be displayed in the Status Box on
the Data Station RUN screen before samples can be analyzed.
• Samples should be well mixed (a rotary mixer is preferred)
before they are run in the Open Mode or the Closed Mode on
the CELL-DYN 3700CS System. The Sample Loader
automatically mixes the samples before aspiration. However,
samples must be well mixed before they are placed in the
Sample Loader racks.

Operator ID
The operator should enter an Operator ID before running
samples. The Operator ID is displayed on all screens and printed
on the graphics report and the blank ticket report. It is also
retained in the QC Logs and the Data Log.
The operator ID can be entered from the MAIN MENU screen or the
CALIBRATION screen. When either screen is selected, the cursor is
positioned in the <OPERATOR ID> entry field. Type up to three
alphanumeric characters and press the Enter key on the keyboard
to save the ID number.

Specimen Identification
A specimen identification name or number can be entered in the
upper left-hand corner of the RUN screen. These entry fields are
made available by pressing the [SPECIMEN TYPE] key followed by
the [PATIENT] key.
1. A Specimen ID name or number of up to 12 characters can
be entered in the <NEXT ID> entry field.

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2. An Auto-Increment feature is available, which automatically


increments the Specimen ID number by 1 each time a
sample is run. It is selected by moving the cursor to the word
AUTO (displayed at the end of the <NEXT ID> entry field). The
[CHANGE SAMPLER] key changes to [TOGGLE AUTO ID]. Press
the [TOGGLE AUTO ID] key to turn the feature ON or OFF. If
the word AUTO is highlighted, the feature is enabled.
Enabling this feature automatically increments the ID
number after the first entry is made.
NOTE: Up to 12 characters can be entered, but the Auto-
Increment feature is limited by the number of characters
currently entered. The number changes to zeros when the
maximum value is reached. For example, if a three-digit ID
number is entered, the number changes from 999 to 000.
If a five-digit number is entered, the number changes from
99999 to 00000. Therefore, leading zeros should precede
the number to maximize the use of this feature. (For
example, 00099.)

3. The remaining patient demographic information may be


entered in the other data entry fields at the operator’s
discretion.
4. The results of the run will be displayed and printed using
Parameter Set 1 and Patient Limit Set 1 if no changes are
made in these entry fields. When the results are displayed
(but before the next sample is run), other parameter and
limit sets can be displayed by moving the cursor to the
appropriate field and typing the desired number.
NOTE: When the results have been stored in the Data Log,
other parameter and limit sets may be selected by using
the [EDIT SPECIMEN] key on the DISPLAY SPECIMEN screen
accessed through the DATA LOG screen. For complete
instructions, refer to Using the Data Log within this
chapter.

Alerts and Indicators


This section describes information displayed on the screen as the
samples are analyzed and/or when reports are printed.
NOTE: This section does not discuss how to interpret
parameter flags, which are displayed after the sample is
run. For detailed explanations of each flag, refer to
Chapter 3: Principles of Operation. For a complete
explanation of metering faults, refer to Chapter 3:
Principles of Operation.
• Results that fall outside the range of the selected limit set are
displayed in color. Yellow indicates that the result fell below
the lower limit, and purple indicates that the result exceeded

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the upper limit. These results are underlined on the graphics


and blank ticket printouts. They are indicated by an asterisk
on pre-printed tickets.
NOTE: Quality Control results that fall at the boundaries of
the selected limit set may be colored differently in the QC
and Data Logs. This is possible due to differences in
numerical rounding between the two logs. The result that
will be displayed, printed and reported is the same in both
logs and is accurate. Use the color in the data log view to
determine whether the results are outside the entered limits.
• Results that exceed a parameter’s linear range are indicated
by >>>> in place of the result.
• If a WIC or RBC/PLT metering fault occurs, results are
suppressed for the affected parameters and the appropriate
CLOG or FLOW ERROR message is displayed. The upper
metering time (WUT or RUT) and count time (WCT or RCT)
are also displayed. These messages and times are also printed
in the graphics report.
• If a WOC Flow Error occurs, results are suppressed for the
WBC and Differential, the WOC FLOW ERROR message is
displayed on the Bulletin Line, and the WBC scatterplots are
displayed in red.
• The message SAMPLING ERROR-INCOMPLETE
ASPIRATION is displayed on the Bulletin Line if insufficient
sample was detected during aspiration. SAMPLING ERROR is
displayed on the screen and “Sampling Err” is printed on the
graphics report to the right of the MCHC. The same message
is printed to the right of the WBC on the pre-printed ticket
and printed above the list of parameters on the blank ticket.
NOTE: The Sample Loader automatically stops if four
consecutive incomplete aspirations or metering faults occur.
The message AUTO SAMPLER/DATA FAULT is displayed on
the Bulletin Line.
NOTE: Sample sensors are automatically disabled during
the processing of Auxiliary specimens. Sample sensor
checks are not performed for Incomplete Aspiration.
• If a fault condition is detected, the [CLEAR FAULT] key on the
RUN screen is displayed and a message appears in the Status
Box (for example: DILUENT EMPTY). The word “Fault” on
the Analyzer Status Indicator Panel is illuminated in red. The
Status Box displays the message FAULT: SEE DIAG or SEE
SPECIAL to direct the operator to the DIAGNOSTICS screen or
the SPECIAL PROTOCOLS screen for further instructions.
NOTE: After the problem has been corrected, pressing the
[CLEAR FAULT] key will allow the instrument to resume
operation.

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Instrument Start Up
The Analyzer and Data Station power switches should be left ON
at all times. The instrument has been designed to automatically
maintain itself when it is idle. If the instrument is idle for five
minutes, a cleaning cycle will be automatically initiated. If the
instrument is idle for four hours, an automatic Shutdown Cycle
will be initiated. The instrument will be placed in the Standby
state at the end of the automatic Shutdown Cycle.
Power to the Printer may be left ON or OFF at the operator’s
discretion. For complete instructions on Printer operation, refer to
Chapter 11: Printers.
Power to the Sample Loader may be left ON or OFF at the
operator’s discretion. For complete instructions on Sample Loader
operation, refer to Chapter 12: Sample Loader.
A complete procedure for turning the system ON or OFF is given
in Chapter 10: Troubleshooting.

Sample Analysis Using the SL Model


Daily Start Up Procedure
The automatic Start Up Cycle is designed to prime the flow system
and check the background counts whenever the Standby or
Initialized message appears in the Status Box on the RUN
screen. The cycle takes approximately 3.5 minutes and is activated
by pressing the [RUN] key or the [PRIME] key. (If the RUN screen is
displayed before initialization is complete, the [PRIME] key will be
displayed instead of the [CLEAR APERTURES] key.)
Before beginning this procedure, ensure that power to all
components is ON. The power to the Analyzer should always be ON.
1. Be sure that the word READY on the Analyzer Status
Indicator Panel is illuminated in green and the Ready
message is displayed in the Status Box on the RUN screen.
2. If the Status Box on the RUN screen displays Standby or
Initialized, press the [RUN] key or the [PRIME] key to
initiate the automatic Start Up Cycle.
3. Be sure that all 10 racks are in the Sample Loader Tray
(5 on each side) and the Safety Cover is in place.
4. Turn the Sample Loader power switch ON. When the Sample
Loader initialization cycle is completed, the indicator on the
Sample Loader Start key will blink and the Bulletin Line on the
RUN screen will display the message AUTO-SAMPLER READY.

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5. When the automatic Start Up Cycle is completed, a


background count is automatically performed and the
Open Mode is selected.
6. Verify that the background counts are acceptable. If the
background counts are unacceptable, repeat the background
cycle. If the counts are still unacceptable, troubleshoot
accordingly, as directed in Chapter 10: Troubleshooting,
Subsection: Troubleshooting Guide.
NOTE: Background counts may be repeated by pressing
the Touch Plate.

7. Perform the daily quality control procedures as directed in


the following section, Daily Quality Control Procedures.
NOTE: Whenever the CELL-DYN 3700 System has been in
standby, before running any control or patient specimen
in the Closed Sampler or Sample Loader Mode, it is
recommended that a prime specimen be run in the Closed
Sampler or Sample Loader Mode first.

Sample Loader Operating Tips


1. All Sample Loader tubing must be connected before turning
ON the Sample Loader, initializing it, or changing modes.
2. All samples must be properly mixed before they are placed in
the Sample Loader racks.
3. Spaces must be left between tubes with rubber stoppers
when they are placed in the Sample Loader Rack. If the tubes
are placed side by side, mixing errors will occur because the
rubber stoppers will touch each other when the tubes spin.
4. If a tube has multiple labels on it, spin the tube by hand
after it is put in a rack to be sure it will spin freely and
therefore mix properly. (For labeling requirements, refer
to Chapter 12: Sample Loader.)

Daily Quality Control Procedures


Quality control procedures (which confirm calibration) should be
performed on a daily basis according to the laboratory’s protocol.
Commercial control materials should be properly warmed and
mixed according to the manufacturer’s recommendations. Patient
controls should be handled according to the laboratory’s protocol.

Open Mode QC Procedure


1. From the RUN screen, press the [SPECIMEN TYPE] key.
2. Move the cursor to the desired QC file and press the
[QC SPECIMEN] key.

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3. If necessary, press the [CHANGE SAMPLER] key to select


the Open Mode.
4. Run the control.
NOTE: For complete instructions on running samples,
refer to Running Samples within this chapter (following
the QC procedures).

5. Verify that the results are acceptable.


NOTE: Out-of-range results are displayed in color.

6. If the results are unacceptable, repeat the run. If the results are
still unacceptable, obtain a new bottle of the control, be sure
that it is warmed and mixed properly, and again repeat the run.
If the results are still unacceptable, run the other levels of
control material. If the results on all levels are unacceptable,
troubleshoot accordingly, as directed in Chapter 10:
Troubleshooting, Subsection: Troubleshooting Guide.
7. When the control results are acceptable, patient samples may
be analyzed.

Closed Mode QC
QC samples can be run on the Sample Loader using the “Q Labels,”
which are bar code labels that are available for the Sample Loader.
Each label is designated Qx, where x indicates the file number. If
these labels are placed on the control tubes, the results are
automatically transmitted to the file indicated by the label. QC
samples can also be run on the Sample Loader without these labels.
NOTE: Be sure the Work List is OFF before beginning
these procedures. If necessary, refer to Work List within
this chapter for instructions.

Closed Mode QC Procedure with Q Labels


1. Label each control tube with the Q Label that indicates the
desired QC file.
2. Be sure that the word READY on the Analyzer Status
Indicator Panel is illuminated in green and the Ready
message is displayed in the Status Box on the RUN screen.
3. Place the labeled tubes in the Sample Loader End Rack and
load the rack in the Sample Loader tray.
4. If necessary, press the [RUN] key to display the RUN screen.
5. If necessary, press the [CHANGE SAMPLER] key to select the
Closed Mode.

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6. Be sure that all 10 racks (5 on each side) and the Safety Cover
are in place and press the Start key on the Sample Loader.
7. The Sample Loader reads the Q Label and transmits the
results to the appropriate QC file.
8. When all controls have been run, press the [MAIN] key
followed by the [QUALITY CONTROL] key.
9. Use the arrow keys on the keyboard to move the cursor to the
desired file.
10. Press the [VIEW QC LOG] key to display the QC log.
11. Verify that the results are acceptable.
NOTE: Out-of-range results are displayed in color.

12. Repeat steps 8–10 for all controls that were run.
13. If the results are unacceptable, repeat the run. If the results
are still unacceptable, obtain a new tube of control, be sure
that it is warmed and mixed properly according to the
manufacturer’s recommendations, and again repeat the run.
If the results are still unacceptable, run the other levels of
control material. If the results on all levels are unacceptable,
troubleshoot accordingly, as directed in Chapter 10:
Troubleshooting, Subsection: Troubleshooting Guide.
14. When the control results are acceptable, patient samples may
be analyzed.

Closed Mode QC Procedure without Q Labels


The operator must manually pause the Sample Loader as directed
in this procedure when different levels of controls are run without
Q Labels.
NOTE: If all QC data are going to the same file, steps 6–10
may be omitted.

1. From the RUN screen, press the [SPECIMEN TYPE] key.


2. Use the arrow keys on the keyboard to move the cursor to the
appropriate QC file and press the [QC SPECIMEN] key.
3. If necessary, press the [CHANGE SAMPLER] key to select the
Closed Mode.
4. Place the controls in the Sample Loader End Rack in the
order in which they are to be run.
NOTE: Leave a space between the control tubes to prevent
mixing errors caused by the stoppers touching each other.

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5. Be sure that all 10 racks (5 on each side) and the Safety Cover
are in place and press the Start key on the Sample Loader.
6. After the first control is aspirated, press the Pause key on the
Sample Loader.
7. After the results are displayed, press the [SPECIMEN TYPE] key.
8. Use the arrow keys on the keyboard to move the cursor to the
file for the next control to be run and press the [QC SPECIMEN]
key.
9. Press the Start key on the Sample Loader.
10. Repeat steps 6–9 until all levels of controls have been run.
11. When all of the controls have been run, press the [MAIN] key
followed by the [QUALITY CONTROL] key.
12. Use the arrow keys on the keyboard to move the cursor to the
desired file.
13. Press the [VIEW QC LOG] key to display the QC Log.
14. Verify that the results are acceptable.
NOTE: Out-of-range results are displayed in color.

15. Repeat steps 11–14 for all levels of controls that were run.
16. If the results are unacceptable, repeat the run. If the results
are still unacceptable, obtain a new tube of control, be sure
that it is warmed and mixed properly, and again repeat the
run. If the results are still unacceptable, run the other levels
of control material. If the results on all levels are
unacceptable, troubleshoot accordingly, as directed in
Chapter 10: Troubleshooting, Subsection: Troubleshooting
Guide.
17. When the control results are acceptable, patient samples may
be analyzed.

Running Samples
Two modes of running samples are available with the SL Model:
• Open Mode Analysis
The Open Sampler Mode aspirates the sample from an
opened collection tube. OPEN SAMPLER is displayed in the
upper right corner of the RUN screen when this mode is
selected. The Open Sample Aspiration Probe is available only
when this mode is selected.

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• Closed Mode Analysis
The Closed Sampler Mode on Sample Loader (SL)
instruments aspirates the sample from a closed collection
tube that has been placed in a Sample Loader Rack and
loaded into the Sample Loader. CLOSED SAMPLER is
displayed in the upper right corner of the RUN screen when
this mode is selected. The Bulletin Line displays the message
AUTO-SAMPLER READY and the Sample Loader Start key
indicator blinks when the Sample Loader is ready. The Wash
Block moves down to the end of the Open Sample Aspiration
Probe when this mode is selected.
NOTE: The last group of samples in a run should be
placed in the Sample Loader rack designated as the End
Rack, which automatically signals the Analyzer to stop
processing. This rack has black dots on the top and a black
bar on the left edge.

Open Mode Procedure


1. If necessary, from the RUN screen press the
[CHANGE SAMPLER] key to select the Open Mode.
2. Be sure that the word READY is illuminated on the Analyzer
Status Indicator Panel and Ready is displayed in the Status
Box on the RUN screen.
3. Open the well-mixed specimen tube and immerse the Open
Sample Aspiration Probe in the specimen.
4. Press the Touch Plate located behind the probe to start the cycle.
The word BUSY on the Analyzer Status Indicator Panel will be
illuminated in yellow, and the Status Box on the RUN screen
will display messages to indicate the various stages of the cycle.
5. Remove the tube when the beep sounds. The Wash Block will
move down the probe and clean it.
6. When the cycle is completed, the Wash Block will move up
the probe, the word READY on the Analyzer Status Indicator
Panel will be illuminated in green, and the results will be
displayed on the RUN screen.
7. If automatic report printing has been specified, a report will
be printed according to the options selected during setup. If
this has not been specified, a report can be printed by
pressing the [PRINT REPORT] key.
NOTE: To obtain a color printout, press the [COLOR PRINT]
key. (The color printing option on the CUSTOMIZE PRINTED
REPORT screen must be ON.) If automatic report printing
has been specified, the reports will be printed in black and
white.

8. Repeat this procedure for subsequent samples.

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Closed Mode Procedure


1. Be sure that the word READY on the Analyzer Status
Indicator Panel is illuminated in green and Ready is
displayed in the Status Box on the RUN screen. The Bulletin
Line should display the message AUTO-SAMPLER READY.
2. If necessary, from the RUN screen press the
[CHANGE SAMPLER] key to select the Closed Mode.
3. Place the well-mixed specimens in the Sample Loader racks
in the order in which they are to be run.
NOTE: The racks and tube positions are identified by the
bar code label on the rack and indicated as RxTx. These
numbers appear as the Specimen ID number if bar code
labels are not used. (If the Work List is used, the Specimen
ID number is taken from it. Refer to Work List within this
chapter for more information.)

4. Place the racks in the Sample Loader Tray with the slotted
side facing the Analyzer.
NOTE: All 10 racks must be in the tray (5 on each side)
for the Sample Loader to operate.

5. Put the Sample Loader Safety Cover in place.


NOTE: The Sample Loader will not operate without the
Safety Cover.

6. Press the Start key on the Sample Loader.


7. The Sample Loader automatically processes all the samples.
Processing stops when the End Rack is finished.

Daily Shutdown
It is not necessary to perform a Daily Shutdown Procedure, as the
instrument automatically goes into a Standby state if it has been
idle for four hours. If desired, the operator may place the
instrument in the Standby state by pressing the
[DAILY SHUTDOWN] key on the second SPECIAL PROTOCOLS screen.
NOTE: The instrument should not be turned off unless
directed to do so by an authorized Abbott Representative
or in case of emergency.

When the key is pressed or when the Automatic Shutdown is


initiated, the cycle:
• Rinses the Flow System.
• Sets the timer control that periodically opens all of the
solenoid valves to prevent pinched tubing.

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Sample Analysis Using the CS Model


Daily Start Up Procedure
The automatic Start Up Cycle is designed to prime the flow system
and check the background counts whenever the Standby or
Initialized message appears in the Status Box on the RUN
screen. The cycle takes approximately 3.5 minutes and is activated
by pressing the [RUN] key or the [PRIME] key. (If the RUN screen is
displayed before initialization is complete, the [PRIME] key will be
displayed instead of the [CLEAR APERTURES] key.)
Before beginning this procedure, ensure that power to all
components is ON. The power to the Analyzer should always be ON.
1. Be sure that the word READY on the Analyzer Status
Indicator Panel is illuminated in green.
2. If the Status Box on the RUN screen displays Standby or
Initialized, press the [RUN] key or the [PRIME] key to
initiate the automatic Start Up Cycle.
3. When the cycle is complete, a background count is
automatically performed and the Open Mode is selected.
4. Verify that the background counts are acceptable. If the
background counts are unacceptable, repeat the background
cycle. If the counts are still unacceptable, troubleshoot
accordingly, as directed in Chapter 10: Troubleshooting,
Subsection: Troubleshooting Guide.
NOTE: Background counts may be repeated by pressing
the Touch Plate.

5. Perform the daily quality control procedure as directed in


the following section, Daily Quality Control Procedure.
NOTE: Whenever the CELL-DYN 3700 System has been in
standby, before running any control or patient specimen
in the Closed Sampler or Sample Loader Mode, it is
recommended that a prime specimen be run in the Closed
Sampler or Sample Loader Mode first.

Daily Quality Control Procedure


The Quality Control Procedure (which confirms calibration)
should be performed on a daily basis according to the laboratory’s
protocol. Commercial control materials should be properly warmed
and mixed according to the manufacturer’s recommendations.
Patient controls should be handled according to the laboratory’s
protocol.

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QC Procedure (Open or Closed Mode)


1. From the RUN screen, press the [SPECIMEN TYPE] key.
2. Move the cursor to the desired QC file and press the
[QC SPECIMEN] key.
3. If necessary, press the [CHANGE SAMPLER] key to select the
desired mode.
4. Run the control.
NOTE: For complete instructions on running samples,
refer to the next section in this chapter, Running Samples.

5. Verify that the results are acceptable.


NOTE: Out-of-range results are displayed in color.

6. If the results are unacceptable, repeat the run. If the results


are still unacceptable, obtain a new bottle of the control, be
sure that it is warmed and mixed properly, and again repeat
the run. If the results are still unacceptable, run the other
levels of control material. If the results on all levels are
unacceptable, troubleshoot accordingly, as directed in
Chapter 10: Troubleshooting.
7. When the control results are acceptable, patient samples may
be analyzed.

Running Samples
Two modes of running samples are available with the CS Model:
• Open Mode Analysis
The Open Sampler Mode aspirates the sample from an
opened collection tube. OPEN SAMPLER is displayed in the
upper right corner of the RUN screen when this mode is
selected. The Open Sample Aspiration Probe is available only
when this mode is selected.
• Closed Mode Analysis
The Closed Sampler Mode on Closed Sampler (CS) instruments
aspirates the sample from a closed collection tube that has been
inserted in the Closed Sampler Module. CLOSED SAMPLER is
displayed in the upper right corner of the RUN screen when this
mode is selected. The Wash Block moves down to the end of the
Open Sample Aspiration Probe when this mode is selected.

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Open Mode Procedure


1. If necessary, from the RUN screen press the [CHANGE
SAMPLER] key to select the Open Mode.
2. Be sure that the word READY is illuminated on the Analyzer
Status Indicator Panel and Ready is displayed in the Status
Box on the RUN screen.
3. Open the well-mixed specimen tube and immerse the Open
Sample Aspiration Probe in the specimen.
4. Press the Touch Plate located behind the probe to start the cycle.
The word BUSY on the Analyzer Status Indicator Panel will be
illuminated in yellow. The Status Box on the RUN screen will
display messages to indicate the various stages of the cycle.
5. Remove the tube when the beep sounds. The Wash Block will
move down the probe and clean it.
6. When the cycle is completed, the Wash Block will move up
the probe, the word READY on the Analyzer Status Indicator
Panel will be illuminated in green, and the results will be
displayed on the RUN screen.
7. If automatic report printing has been specified, a report will
be printed according to the options selected during setup. If
this has not been specified, a report can be printed by
pressing the [PRINT REPORT] key.
NOTE: To obtain a color printout, press the [COLOR PRINT]
key. (The color printing option on the CUSTOMIZE PRINTED
REPORT screen must be ON.) If automatic report printing has
been specified, the reports will be printed in black and white.

8. Repeat this procedure for subsequent samples.

Closed Mode Procedure


1. Be sure that the word READY is illuminated on the Analyzer
Status Indicator Panel and Ready is displayed in the Status
Box on the RUN screen.
2. If necessary, from the RUN screen press the
[CHANGE SAMPLER] key to select the Closed Mode.

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3. Invert the well-mixed specimen and place the stoppered end


down into the Closed Sampler Module. Push the end of the
tube securely into the Tube Retainer.
NOTE: Place the tube cap-down and make sure it is seated
correctly. (The Touch Plate will not operate if the tube is
not seated correctly.) For instructions on adjusting the
Tube Retainer, refer to Chapter 9: Maintenance,
Subsection: Special Procedures.

4. Press the Touch Plate located behind the probe to start the
cycle. The word BUSY on the Analyzer Status Indicator Panel
will be illuminated in yellow.
5. Remove the tube when the beep sounds.
6. When the cycle is completed, the word READY on the
Analyzer Status Indicator Panel will be illuminated in green,
and the results will be displayed on the RUN screen.
7. Repeat this procedure for subsequent samples.

Daily Shutdown
It is not necessary to perform a Daily Shutdown Procedure, as the
instrument automatically goes into a Standby state if it has been
idle for four hours. If desired, the operator may place the instrument
in the Standby state by pressing the [DAILY SHUTDOWN] key on the
second SPECIAL PROTOCOLS screen.
When the key is pressed or when the Automatic Shutdown is
initiated, the cycle:
• Rinses the Flow System.
• Sets the timer control that periodically opens all of the
solenoid valves to prevent pinched tubing.

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Using The Work List


The Work List is used to preassign sample identification and to
display and print criteria for samples that will be run. It is
essentially a list of the samples (including the preassigned
information) that the operator intends to run on the instrument.
A Work List can be downloaded from a host computer to the
CELL-DYN 3700 System. Its use is optional.
The Work List can be used with or without bar coded specimens.
Instructions for both methods are presented under the specific
Work List discussions. Instructions are also given for handling
STAT samples with and without bar code labels.
CAUTION: If bar code labels are not used, samples must
be processed in the same order in which the information is
listed on the Work List.
The following bar code symbologies may be used:
• Codabar, Interleaved 2 of 5, Code 39, or Code 128
These bar code labels are often generated by the laboratory
and are typically used when the bar code number is the
Specimen ID number.
• CELL-DYN 4-Digit Bar Code (Code 39)
These bar code labels are provided with the Sample Loader
and may be used for sample identification when the bar code
number is not the same as the Specimen ID number. This
option must be selected in the Work List setup.
NOTES 1. The bar code reader searches for a readable code
when it reads a bar code label. It then performs multiple
reads to verify that the code has been read correctly. If a
second bar code label from a different patient is applied to
the tube, it may be ignored by the bar code reader.
Consequently, the possibility for misidentification exists.
Good laboratory practice mandates that each specimen is
labeled with information traceable to one patient only.
Therefore, it is recommended that only one bar code label is
used on each tube for correct specimen identification.
NOTES 2. For complete information on the use of bar codes,
refer to Appendix A: Bar Codes.
As the samples are processed, the Work List is accessed, and the
entered information is displayed on the RUN screen with the results
stored in the Data Log. The information is also printed on the report.
When using the Work List feature, set up a laboratory procedure
to require that any unprocessed Work List entries be viewed and
cleared at the end of each shift or day. This will reduce the
opportunity for any unprocessed Specimen IDs, left in the Work
List for an extended time, to be matched with a different patient
with the same Specimen ID.

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Work List Screen


WORK The [WORK LIST] key on the Data Station RUN screen is used to
LIST display the WORK LIST screen. (See the following figure.) The
following soft key labels are displayed on the WORK LIST screen:

WORK LIST ON or
WORK LIST OFF (This key label alternates between
these two selections.)
BAR CODE ON or
BAR CODE OFF (This key label alternates between
these two selections.)
INSERT/DELETE
DELETE ALL
PURGE COMPLETED
WORK LIST SET UP
PRINT WORK LIST
RETURN

1 Work List ON WORK LIST Dec 07 1998 12:09


Ready Operator ID 753
Sequence # 0330
2 Bar Code ON
3 4 5 6 7 8 9 10 11 12
# 4DIG SPECIMEN SPECIMEN L P DOCTOR DATE OF S RACK/
BC ID NAME BIRTH TUBE

11 123456 Jones, Mary 1 1 1 1 --/--/-- N


2 234567 Smith, John 1 1 A
3 345678 White, Bob 1 1 F
4 456789 Black, Sue 1 1
5 567890 Green, Kermit 1 1
6 1 1

WORK LIST BAR CODE INSERT/ DELETE PURGE WORK LIST PRINT RETURN
OFF OFF DELETE ALL COMPLETED SET UP WORK LIST

Figure 5.40: Work List Screen

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The numbers on the WORK LIST screen (shown in the preceding


figure) correspond with the following numbered options:
1. <WORK LIST>
The status of the Work List (OFF or ON) is displayed in this
field.
2. <BAR CODE>
The status of the Bar Code selection (OFF or ON) is displayed
in this field.
3. <#>
The sequential number of the Work List entries is displayed
in this field. The Work List holds 800 entries. When the
Work List is full, existing entries must be deleted before
additional entries can be made.
4. <4DIG BC> (4-Digit Bar Code)
If the 4-digit bar code was selected from the
WORK LIST SET UP screen and the Bar Code option is ON, the
bar code number must be entered in this field.
5. <SPECIMEN ID>
A bar code number, specimen identification number, or
name can be entered in this field. Up to 12 characters can be
entered. The sample is identified on the RUN screen, in the
Data Log, and on the printed report using the information
entered in this field.
NOTE: An entry must be made in this field to create a
Work List.

6. <SPECIMEN NAME>
The name entered in this field should be associated with the
identification number entered in the <SPECIMEN ID> field. Up
to 16 characters can be entered in this field.
7. <L> (Limit Set)
This field is used to enter the number of the Patient Limit Set
that will be used for flagging the sample. If no entry is made,
the default (pre-selected) Patient Limit Set will be used.
8. <P> (Parameter Set)
This field is used to enter the number of the Parameter Set
that will be used for the sample. If no entry is made, the
default (preselected) Parameter Set will be used.

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9. <DOCTOR>
This field is used to enter the name of the patient’s physician.
10. <DATE OF BIRTH>
This field is used to enter the date of birth of the patient.
11. <S> (Status)
As the samples are processed, the status is indicated in this
field. The operator cannot enter information in this field.
The following codes may be displayed:
N Non-Alerted
The sample was not flagged in any way.
A Alerted
The sample was flagged because results exceeded
the selected Patient Limits or because a
morphological flag was generated.
F Fault
A Metering Fault (for WIC or RBC/PLT) or a
Sampling Error message was generated as the
sample was processed, either with or without the
Sample Loader; or a Mixing Error message was
generated as the sample was processed (only when
using the Sample Loader).
12. <RACK/TUBE>
As samples are processed on the Sample Loader, the rack
number and tube number (position of the tube in the rack)
are displayed in this field. The operator cannot enter
information in this field. The display shows RxTx (where x
indicates the number of the rack or tube).

Work List Soft Keys


The function of each of the soft keys displayed on the WORK LIST
screen is as follows:

Work List ON/Work List OFF Soft Key


WORK The [WORK LIST ON] key is used to turn on the Work List feature.
LIST ON The key label changes to [WORK LIST OFF] when the Work List
WORK feature is enabled. The upper left-hand corner of the screen
LIST OFF
indicates the status of the Work List.

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Bar Code ON/Bar Code OFF Soft Key


BAR CODE The [BAR CODE ON] key is used to create a Work List for samples
ON that are identified with bar code labels. The key label changes to
BAR CODE
OFF
[BAR CODE OFF] when the Bar Code feature is enabled. The upper left
corner of the screen indicates the status of the Bar Code feature.

Insert/Delete Soft Key


INSERT/ When the [INSERT/DELETE] key is pressed, the following soft key
DELETE labels are displayed:
INSERT
DELETE

Insert Soft Key


INSERT The [INSERT] key is used to insert a line of information into the
Work List. The line is inserted at the cursor position, and the
remainder of the Work List is moved down one line.

Delete Soft Key


DELETE The [DELETE] key is used to delete a line of information from the
Work List. (When information is deleted, the line remains blank.)
When the [DELETE] key is pressed, the following soft key labels are
displayed:
CONFIRM DELETION
CANCEL DELETION
These keys are used to confirm or cancel the [DELETE] command.

Delete All Soft Key


DELETE The [DELETE ALL] key is used to delete all data from the Work List.
ALL When the [DELETE ALL] key is pressed, the following soft key labels
are displayed:
CONFIRM DELETION
CANCEL DELETION
These keys are used to confirm or cancel the [DELETE ALL]
command.

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Purge Completed Soft Key


PURGE The [PURGE COMPLETED] key is used to delete all Work List entries
COMPLETED for samples that have been successfully run through the Analyzer
(marked with an N or A in the Status field). When the
[PURGE COMPLETED] key is pressed, the Bulletin Line displays the
following message:
ALL SPECIMENS MARKED WITH ‘N’ OR ‘A’ WILL BE
PURGED
The following soft key labels are displayed:
CONFIRM
CANCEL
These keys are used to confirm or cancel the [PURGE COMPLETED]
command.

NOTE: The Purge Completed option is not available when


the Bar Code feature is OFF.

Work List Set Up Soft Key

WORK LIST SET UP Dec 18 1998 10:09


Ready Operator ID sh
Sequence # 0630

1 1 Bar Code ID associated with :


1 = 4-digit bar code
2 = Laboratory Specimen ID

2 OFF Specimen Name entry selected

3 OFF Patient Limits entry selected


4 1 Default Patient Limit Set (1..4)

5 OFF Parameter Set entry selected


6 1 Default Parameter Set (1..4)

7 OFF Doctor Name entry selected

8 OFF Date of Birth entry selected

TOGGLE RETURN
ON/OFF

Figure 5.41: Work List Set Up Screen

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The [WORK LIST SET UP] key on the WORK LIST screen is used to
WORK LIST
SET UP display the WORK LIST SET UP screen shown in the preceding
figure. The numbers on the screen correspond to the following
numbered options:
1. <Bar Code ID associated with:>
1 = 4-digit bar code
2 = Laboratory Specimen ID
This field is used to specify the type of bar code that will be
used when the Bar Code feature is ON. If option 2 is selected,
the bar code number must be entered in the <Specimen ID> field.
2. <Specimen Name entry selected>
This field is used to specify whether a specimen name will be
entered in the Work List.
3. <Patient Limits entry selected>
This field is used to specify which Patient Limits are assigned
to each sample. The default Patient Limit Set will be used if
no specification is made.
4. <Default Patient Limit Set (1..4)>
This field is used to specify the default (preassigned) Patient
Limit Set that will be automatically assigned to each sample
unless otherwise indicated in the Work List.
5. <Parameter Set entry selected>
This field is used to specify which Parameter Set will be
assigned to each sample. The Default Parameter Set will be
used if no specification is made.
6. <Default Parameter Set (1..4)>
This field is used to specify the default (preassigned)
Parameter Set that is automatically assigned to each sample
unless otherwise indicated in the Work List.
7. <Doctor Name entry selected>
This field is used to specify whether a doctor name will be
entered in the Work List.
8. <Date of Birth entry selected>
This field is used to specify whether the patient’s date of
birth will be entered in the Work List.

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Print Work List Soft Key


PRINT The [PRINT WORK LIST] key is used to print the Work List.
WORK LIST

Return Soft Key


RETURN The [RETURN] key is used to return to the RUN screen.

Work List Set Up Procedures


The CELL-DYN 3700 Work List is used to enter and then display
demographic information for specimens that will be processed.
The Work List is created by downloading the demographic
information from an LIS system or by manually entering the
information into selected fields. In either case, the Work List
connects the demographics to the appropriate specimen and
displays them on the specimen report.

Work List Set Up With A Laboratory Information System (LIS)


The directions for setting up the Work List by downloading
information from an LIS are included in the Host Interface
Specification, List No. 02H33-01. Please note that all fields should
be transmitted; therefore, selections in the Work List Setup menu
are not used for this option and no data entry procedure is
needed.
When using the LIS communication feature to receive work
orders from the LIS or send records to the LIS:
DO NOT use a Specimen ID with trailing spaces in the Work List
entry. Trailing spaces will be removed and may result in entries
remaining in the Work List.
DO NOT use a comma in the bar code string, if you use a Sample
Loader instrument AND Code 128-type bar codes. A comma will
cause the Specimen ID to be truncated at the point where the
comma is located within the ID. This will result in an erroneous
Specimen ID or Rack and Tube Number, without any error
notification.

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Work List Set Up with Manual Entry


The first step in generating a work list is to select the demographic
items that will be displayed on the specimen report. All selections
are optional; however, certain selections may be required by the
laboratory. The operator customizes (Sets up) the work list to
accommodate the laboratory’s requirements. When the Work List
Set Up is complete, the selected fields are highlighted indicating
that information must be entered. The second step in generating
the work list is the manual entry of information in each
highlighted field.

The following procedure is used to make the selections for manual


entry.

Manual Entry Procedure


1. From the RUN screen, press the [WORK LIST] key followed by
the [WORK LIST SET UP] key to display the WORK LIST SET UP
screen.
2. Select the type of bar code that will be used.
• Type 1 to use the CELL-DYN Series 4-digit bar code.
• Type 2 to use a laboratory-generated bar code.
Press the Enter key on the keyboard to save the selection and
advance the cursor.
3. The cursor advances to the Specimen Name entry field. Press
the [TOGGLE ON/OFF] key to select (or deselect) a Specimen
Name entry. The cursor advances to the <Patient Limits> entry
field.
4. Press the [TOGGLE ON/OFF] key to select (or deselect) the
Patient Limits entry option. The cursor advances to the
<Default Patient Limit Set> entry field.
5. Select a Patient Limits Set to be used for the default (pre-
assigned) limit as follows:
Type the number of the desired Limit Set (1-4) and press the
Enter key on the keyboard. The cursor advances to the
<Parameter Set> entry field.

6. Press the [TOGGLE ON/OFF] key to select (or deselect) the


Parameter Set entry option. The cursor advances to the
<Default Parameter Set> entry field.
7. Select a Parameter Set to be used for the default (pre-
assigned) set as follows:

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Type the number of the desired Limit Set (1-4) and press the
Enter key on the keyboard. The cursor advances to the
<Doctor Name> entry field.

8. Press the [TOGGLE ON/OFF] key to select (or deselect) the


Doctor Name entry option. The cursor advances to the
<Date of Birth> entry field.
9. Press the [TOGGLE ON/OFF] key to select (or deselect) the <Date
of Birth> entry option. The cursor advances to the next entry
field.

Using the Work List with Bar Code Numbers


When the Work List ON option is selected, the samples are
automatically matched with the created Work List.
When the Bar Code ON option is selected, the bar code labeled
samples may be run in any order after the Work List has been
created.
The Work List is accessed randomly as the samples are processed.
After a bar code label is read, the software searches the Work List
for a matching specimen. When a match is found, the entered
information is transferred from the Work List to the appropriate
field(s) on the RUN screen and is also retained in the Data Log.
The samples may be run in any order since the Work List searches
for the match between the bar code and the appropriate
information in the Work List. The specimen identification
number entered in the Work List <SPECIMEN ID> field is used to
identify the sample on the RUN screen and in the Data Log.
NOTE: Special Bar Code labels, Q Labels, are available to
identify QC samples. The Q Label identifies the sample as
a QC sample so the results are automatically transmitted
to the appropriate QC file. Consequently, QC samples
should not be entered in the Work List. To run QC
samples, turn the Work List OFF and refer to Routine
Operation, Sample Analysis, Daily Quality Control
Procedures, within this chapter for instructions for
running QC samples.

1. If necessary, from the main WORK LIST screen, press the


[WORK LIST ON] key to enable the Work List.
2. If necessary, press the [BAR CODE ON] key to enable the bar
code reading function.

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As indicated earlier in the Work List section, two types of bar code
labels can be used on the Cell-Dyn 3700 as described in the
following paragraphs.

Cell-Dyn 4-Digit Bar Code Number Labels


CELL-DYN 4-digit bar code number labels are available for
laboratories that do not generate their own bar code labels but
would like to process bar code labeled specimens for more
accurate identification. Consequently, when a CELL-DYN 4-digit
bar code number is used, the number must be typed in the Work
List <4-DIGIT BAR CODE> field in order for the instrument to
recognize it as a bar code. Additionally, a specimen ID number
must be entered in the Work List <SPECIMEN ID> field for proper
identification by Specimen ID on the RUN screen and in the Data
Log.

Procedure for 4-Digit Bar Code Numbers


1. With the cursor in the <4DIG BC> field, type in the first 4-
digit bar code number and press the Enter key on the
keyboard. The cursor advances to the <SPECIMEN ID> field.
2. Type the corresponding Specimen ID in the <SPECIMEN ID>
field. Press the Enter key on the keyboard to save the entry
and advance the cursor to the next field highlighted for data
entry.
NOTE: A Specimen ID must be entered into the Specimen
ID field to properly identify each specimen. The 4-digit
bar code only provides a link to the Work List in order to
access the demographic information.

3. Type the appropriate information into the other selected


(highlighted) Work List fields.
4. After each entry, press the Enter key on the keyboard to save
the entry and advance the cursor.
5. Continue to enter the 4-digit bar code numbers and the
corresponding specimen information as described above.

Laboratory-Generated Bar Code Numbers


Many laboratories generate their own bar code labels. These bar
code numbers are used to identify specimens for processing. In
other words, the bar code number is equivalent to the Specimen
ID number. Consequently, when a laboratory-generated bar code
number is used, it must be typed in the Work List <SPECIMEN ID>
field. The samples will then be properly identified by Specimen ID
on the RUN screen and in the Data Log.

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Procedure for Laboratory Generated Bar Code Numbers


1. With the cursor in the <SPECIMEN ID> field, type in the first
laboratory-generated bar code number and press the Enter
key on the keyboard. The cursor advances to the next selected
(highlighted) field.
2. Type the appropriate information into the other selected
(highlighted) Work List fields.
3. After each entry, press the Enter key on the keyboard to save
the entry and advance the cursor.
4. Continue to enter the code numbers and the corresponding
specimen information as described above.

Sample Analysis Using the Work List


The Work List is available in the Open and Closed Modes on both
the SL and CS models of the CELL-DYN 3700. The Work List
option may be used with or without bar code labeled tubes. When
bar code labeled tubes are used, Work List use in all modes is
identical except that the Sample Loader automatically reads the
bar code label on the tube with a built-in bar code reader. A hand
held bar code reader is available to read bar code labeled tubes for
the Open Mode on the CS or SL and the Closed mode on the CS
instrument.

NOTE: Special bar code labels, Q Labels, are available to


identify QC samples so results are automatically
transmitted to the appropriate file. Consequently, QC
samples should not be entered in the work list.

Refer to Appendix A: Bar Codes for a complete discussion of bar


code specifications, bar code labels, and instructions for placing
labels on the tubes correctly.

Sample Analysis Procedures for the Cell-Dyn 3700SL


The Work List may be used in the Open and Closed Modes on the
SL Model and use is similar in each mode. For ease of
understanding, the modes are discussed independently in this
section.

NOTE: If a sample needs to be repeated, turn the Work


List OFF before running the sample again. When the repeat
run is completed, turn the Work List ON and continue to
process samples in the order in which they were entered in
the Work List.

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Procedure: Sample Analysis with Bar Codes in the


Closed Mode
1. After the information for all samples has been entered, place
the samples in the Sample Loader Racks. Samples may be
placed in the racks in any order since the bar code labels will
be used to identify them
NOTE: The last group of samples should be placed in an
End Rack so the Sample Loader will stop when all the
samples have been processed

2. Install the Sample Loader Safety Cover.


3. Press the [RETURN] key to return to the RUN screen.
4. Press the [SPECIMEN TYPE] key followed by the [PATIENT] key.
5. If necessary, press the [CHANGE SAMPLER] key to select the
Closed Mode.
6. Press the Start key on the Sample Loader.
NOTE: Samples can be run with the WORK LIST screen
displayed. As the samples are processed, the status of each
sample will be displayed in the <STATUS> field on the Work
List. Additional entries can be made to the Work List while
processing takes place.

7. The samples are automatically processed in the order in


which they were placed in the racks. If the last samples were
placed in an End Rack, the Sample Loader will automatically
stop when processing is finished.

Procedure: Sample Analysis with Bar Codes


in the Open Mode
1. After the information for all samples has been entered, press
the [RETURN] key to return to the RUN screen
2. Press the [SPECIMEN TYPE] key followed by the [PATIENT] key.
3. If necessary, press the [CHANGE SAMPLER] key to select the
Open mode.
4. Ensure that the cursor is in the <NEXT ID> field.
5. Using the hand held bar code reader, scan the bar code label
on the tube. If the hand held reader is unavailable, type the
Specimen ID in the <NEXT ID> field.
6. Aspirate the sample.

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Routine Operation Chapter 5

NOTE: Samples can be run with the WORK LIST screen


displayed. As the samples are processed, the status of each
sample will be displayed in the <STATUS> field on the Work
List. Additional entries can be made to the Work List while
processing takes place.

7. As each sample is processed, the Work List is searched for the


bar code number. When a match is found, the entered
information is transferred from the Work List to the RUN
screen and is also displayed in the Data Log.

Running STAT Samples


A STAT sample with a laboratory generated bar code label may be
run at any time in any mode. A specimen with 4-digit bar code
label must be added to the Work List with a Specimen ID so that it
will be properly identified. The demographics for a STAT sample
may be added to the Work List at any time unless the Work List is
full (The Work List holds 800 entries.).

Sample Analysis Procedures for the Cell-Dyn 3700CS


The Work List may be used in the Open and Closed Modes on the
CS Model. On CS instruments, use of the Work List is identical in
both modes; therefore, they are described as one in this section.

The CS model has a hand held Bar Code reader which can be used
to read the bar code labels for tubes processed in either mode.

NOTE: If a sample needs to be repeated, turn the Work


List OFF before running the sample again. When the repeat
run is completed, turn the Work List ON and continue to
process samples in the order in which they were entered in
the Work List.

Procedure: Sample Analysis with Bar Codes in the


Closed Mode
1. After the information for all samples has been entered in the
Work List, press the [RETURN] key to return to the RUN screen
2. Press the [SPECIMEN TYPE] key followed by the [PATIENT] key.
3. If necessary, press the [CHANGE SAMPLER] key to select the
Closed Mode.
4. Ensure that the cursor is in the <NEXT ID> field.

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5. Using the hand held bar code reader, scan the bar code label
on the tube. If the hand held reader is unavailable, type the
Specimen ID in the next ID field.
6. Aspirate the sample.
NOTE: Samples can be run with the WORK LIST screen
displayed. As the samples are processed, the status of each
sample is displayed in the <STATUS> field on the Work List.
Additional entries can be made to the Work List while
processing takes place.

7. As each sample is processed, the Work List is searched for the


bar code number. When a match is found, the entered
information is transferred from the Work List to the RUN
screen and is also displayed in the Data Log.

Procedure: Sample Analysis with Bar Codes in the


Open Mode
1. After the information for all samples has been entered, press
the [RETURN] key to return to the RUN screen.
2. Press the [SPECIMEN TYPE] key followed by the [PATIENT] key.
3. If necessary, press the [CHANGE SAMPLER] key to select the
Open Mode.
4. Using the hand held bar code reader, scan the bar code label
on the tube. If the hand held reader is unavailable, type the
Specimen ID in the next ID field.
5. Aspirate the sample.
NOTE: Samples can be run with the WORK LIST screen
displayed. As the samples are processed, the status of each
sample is displayed in the <STATUS> field on the Work List.
Additional entries can be made to the Work List while
processing takes place.

6. As each sample is processed, the Work List is searched for the


bar code number. When a match is found, the entered
information is transferred from the Work List to the RUN
screen and is also displayed in the Data Log.

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Running STAT Samples


A STAT sample with a laboratory generated bar code label may be
run at any time in any mode. A specimen with 4-digit bar code
label must be added to the Work List with a Specimen ID so that it
will be properly identified. The demographics for a STAT sample
may be added to the Work List at any time unless the Work List is
full (The Work List holds 800 entries.).

Using the Work List Without Bar Codes


When the Bar Code OFF option is selected, the Work List is
accessed sequentially as the samples are processed: therefore,
samples must be run in the order in which the information has
been entered in the Work List.

Samples are identified from the information entered in the


<SPECIMEN ID> field on the Work List. If no entries are made in the
<SPECIMEN ID> field, the Sample Loader will identify the sample by
the Rack and Tube number (position of the tube in the rack). This
identification will be displayed as RxTx (where x indicates the
number of the rack or tube).

CAUTION: If a Sample Loader fault occurs that


necessitates re-initialization of the Sample Loader, remove
all samples that have been processed before reinitializing
the Sample Loader. If these samples are not removed, the
remaining samples will be misidentified.

On both the Cell-Dyn 3700SL and Cell-Dyn 3700CS instruments,


use of the Work List without bar codes is identical; therefore, they
are described together in the following procedure.

Procedure: Sample Analysis Without Bar Codes


1. After the information for all samples has been entered in the
Work List, press the [RETURN] key to return to the RUN
screen.
2. Press the [SPECIMEN TYPE] key followed by the [PATIENT] key.
3. If necessary, press the [CHANGE SAMPLER] key to select the
desired mode.
4. Press the [WORK LIST] key to select the Work List screen.

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NOTE: Misidentification of samples can occur if they are


not processed in the order of entry into the Work List.
Consequently, it is recommended that the WORK LIST
screen be displayed or printed. when running samples
without bar codes. The status of each sample is displayed
in the <STATUS> field on the Work List and additional
entries can be made while processing takes place.

5. Aspirate the sample.


6. As each sample is processed, the entered information for the
next sequential specimen ID number is transferred from the
Work List to the RUN screen and is also displayed in the Data
Log. Therefore, samples must be processed in the order in
which information has been entered into the Work List, to
avoid misidentification.

Running STAT Samples


It is important to turn the Work List OFF before running a STAT
sample. When the STAT sample run is completed, turn the Work
List ON and continue to process samples in the order in which
they were entered in the Work List.

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NOTES

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Chapter 5 Using The Data Log

Using The Data Log

The Data Log stores all data and demographic information in a log
format for the last 10,000 cycles run on the CELL-DYN 3700
System. This record information is stored chronologically by
sequence number. Scatterplots and histograms are also stored for
all 10,000 records.

DATA LOG Dec 21 1998 16:32


Ready Operator ID rcs
USE < OR > FOR MORE DATA Sequence # 0844

Seq Specimen ID WBC NEU LYM MONO EOS BASO Date Time Op
r 833 1912584436 3.83 2.30 .315 1.04 .012 .173 C07/21/98 14:40 rcs
r 834 1910952241 7.50 4.53 2.16 .536 .106 .141 C07/21/98 14:40 rcs
r 835 1912077932 .192 .052 .116 .012 .002 .010 C07/21/98 14:41 rcs
r 836 1911764321 6.26 4.99 .828 .252 .019 .176 C07/21/98 14:42 rcs
r 837 1911815501 4.37 2.75 .984 .519 .001 .116 C07/21/98 14:43 rcs
r 838 1911187621 7.07 6.02 .612 .218 .069 .150 C07/21/98 14:43 rcs
839 low ctrl 8.06 4.71 2.44 .621 .213 .074 O07/21/98 16:20 rcs
840 low ctrl 7.96 4.78 2.32 .601 .183 .080 O07/21/98 16:20 rcs
841 low ctrl 8.21 4.86 2.45 .598 .204 .099 O07/21/98 16:21 rcs
w 842 7.93 4.71 2.39 .557 .178 .092 K07/21/98 16:26 rcs
b 843 8.34 4.97 2.50 .551 .208 .114 O07/21/98 16:28 rcs
844 BACKGROUND .079 O07/21/98 16:30 rcs

Seq Specimen ID WBC NEU LYM MONO EOS BASO Date Time Op

EDIT DISPLAY FIND REJECT CUSTOMIZE TRANSMIT PRINT MAIN


ID SPECIMEN SPECIMEN FROM X-B DATA LOG DATA DATA LOG

Figure 5.42: Data Log Screen

NOTE: Press the F12 key followed by the F1 key on the


keyboard to toggle between this Data log screen and the
Retic Data Log screen.

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Data Log Menu


DATA The [DATA LOG] key on the MAIN MENU is used to display the DATA LOG
LOG screen (see the preceding figure) and the following soft key labels:
EDIT ID (This key label is displayed only if the
cursor is positioned next to a patient
record.)
DISPLAY SPECIMEN
FIND SPECIMEN
REJECT FROM X-B (This key label is displayed if the sequence
number of the patient record is preceded
by a b, r, or w. See the preceding figure.)
CUSTOMIZE DATA LOG
TRANSMIT DATA
PRINT DATA LOG
MAIN
Information that can be viewed from the DATA LOG screen
includes the following:
• Sequence number and specimen ID assigned to the sample
(left portion of screen). A b, r, or w may appear to the left of
the sequence number.
b – Specimen is included in both X-B WBC and X-B RBC
Analysis
r – Specimen is included in X-B RBC Analysis
w – Specimen is included in X-B WBC Analysis
• Set of parameter data that can be customized by pressing the
[CUSTOMIZE DATA LOG] key (center portion of screen).
• Date and time sample was run and operator ID (right portion
of screen).

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Also listed in the right portion of the DATA LOG screen,


immediately to the left of the date, is a letter. This letter represents
the following Data Log codes that identify conditions of the
sample run:
O — Sample was run in the Open Mode
C — Sample was run in the Closed Mode
N — Incomplete aspiration in the Open Mode
I — Incomplete aspiration in the Closed Mode
K — WIC or RBC/PLT metering fault (Clog or Flow Error)
M — Mixing error on the Sample Loader
R — Resistant RBC key was used to run this sample
V — Sample was run in the Veterinary mode
B — Blood in line
A — Auxiliary
The keys and functions accessible from the DATA LOG screen are
described on the following pages.

Edit ID Soft Key


EDIT The [EDIT ID] key is used to edit the specimen ID displayed on the
ID DATA LOG screen. When the [EDIT ID] key is pressed, the cursor
moves into the <SPECIMEN ID> field and all key labels are blank.
Edits are saved by pressing the Enter key on the keyboard after the
new ID is entered.
NOTE: The [EDIT ID] key is available only when the cursor
is positioned next to a patient record. It is not available for
background or QC records.

When using the Edit Specimen ID feature in the Data Log, set up a
laboratory procedure to verify any Specimen ID that has been
manually edited in the Data Log by showing the content of the
Specimen ID before and after editing.
Such verification could be:
Printouts of the Data Log summary reports that show the edited
ID. These printouts should be signed, dated and saved to ensure
tracking of any changes to specimen identification within your
laboratory.
or
Re-running any specimen unintentionally identified with a Rack
and Tube Number, via Open or Closed Mode, to confirm that the
correct Specimen ID is applied.

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Display Specimen Soft Key

Spec ID R7 T4 DISPLAY SPECIMEN Dec 07 1998 08:19


Patient ---------------- Ready Operator ID baC
Sex(M/F):- DOB:--/--/-- Sequence # 0863
Dr ---------------------- Sequence # 826 Closed Sampler
Param: 2 Limits: 1 SUSPECT
G
WBC 7.28 K/uL (WOC)
R
NEU 4.51 62.0 %N S A
LYM 1.81 24.9 %L VAR LYM I N
MONO .745 10.2 %M NRBC Z L
E R
EOS .097 1.33 %E
T
BASO .111 1.53 %B DFLT (LM) Y
WCT:4.46
RBC 4.05 M/uL COMPLEXITY LOBULARITY
HGB 12.0 g/dL
HCT 35.7 %
MCV 88.1 fL
MCH 29.5 pg
MCHC 33.5 g/dL
RDW 16.0 %

PLT 266. K/uL


MPV 9.05 fL RCT:6.53 RBC PLT
Auto-Sampler Ready
PREVIOUS NEXT EDIT CUSTOMIZE TRANSMIT PRINT PRINT RETURN
SPECIMEN SPECIMEN SPECIMEN REPORT SPECIMEN TICKET REPORT

Figure 5.43: Display Specimen Screen

DISPLAY The [DISPLAY SPECIMEN] key on the DATA LOG screen is used to
SPECIMEN display the results for the record indicated by the cursor position.
(See the preceding figure.) The following soft key labels are
displayed on the DISPLAY SPECIMEN screen:
PREVIOUS SPECIMEN This label key is not displayed when
the first specimen in the log is on the
screen.
NEXT SPECIMEN This label key is not displayed when the last
specimen in the log is on the screen.
EDIT SPECIMEN This label key is displayed for the
patient records only.
CUSTOMIZE REPORT
TRANSMIT SPECIMEN
PRINT TICKET
PRINT REPORT or
COLOR PRINT (The key label alternates between
these two selections, depending on
whether the Color Print option has
been enabled.)
RETURN

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Previous Specimen Soft Key


PREVIOUS The [PREVIOUS SPECIMEN] key on the DISPLAY SPECIMEN screen is
SPECIMEN used to display the results for the sequence number preceding the
one currently displayed without returning to the main DATA LOG
screen.

Next Specimen Soft Key


NEXT The [NEXT SPECIMEN] key is used to display the results for the
SPECIMEN sequence number following the one currently displayed without
returning to the main DATA LOG screen.

Edit Specimen Soft Key


EDIT The [EDIT SPECIMEN] key is used to edit patient demographic
SPECIMEN information for the selected record. It may also be used to edit and
display the results using a Parameter Set or Patient Limit Set
different from the one currently displayed. The following soft key
labels are displayed when the [EDIT SPECIMEN] key is pressed:

CONFIRM
CANCEL
These keys are used to [CONFIRM] or [CANCEL] the edits. The
Bulletin Line displays the following message: PRESS CONFIRM
TO SAVE CHANGES OR CANCEL TO CANCEL CHANGES. When
the [CONFIRM] key is pressed, the edited record is displayed.

Customize Report Soft Key


CUSTOMIZE The [CUSTOMIZE REPORT] key is used to customize the RUN screen
REPORT display, header, and printout as described in Set Up Instructions
within this chapter.

Transmit Specimen Soft Key


TRANSMIT The [TRANSMIT SPECIMEN] key is used to transmit the displayed
SPECIMEN report to a Laboratory Information System or on-line computer.

Print Ticket Soft Key


PRINT The [PRINT TICKET] key is used to print a ticket (in the currently
TICKET selected format) for the displayed record.

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Print Report Soft Key


PRINT The [PRINT REPORT] key is used to print a graphics report (in the
REPORT currently selected format) for the displayed record.
COLOR
PRINT
NOTE: If color printing has been selected (refer to Set Up
Instructions within this chapter), the key label changes to
[COLOR PRINT].

Return Soft Key


RETURN The [RETURN] key is used to return to the main DATA LOG screen.

Find Specimen Soft Key

SEQ #:
SPEC ID: DATA LOG SEARCH Dec 21 1998 15:56
NAME: Ready Operator ID rcs
Sequence # 0711

Seq Specimen ID WBC WIC WOC RBC HGB MCV RDW Date Time Op
700 BACKGROUND .006 .006 .006 0.00 .027 O07/20/98 14:38 rcs
b 701 1911937231 9.42 9.89 9.42 3.76 10.1 82.0 16.8 C07/20/98 14:42 rcs
r 702 1911359331 5.52 6.44 5.52 3.88 10.2 81.4 13.3 C07/20/98 14:43 rcs
703 1911883246 11.4 11.9 11.4 10.1 K07/20/98 14:43 rcs
704 LATEX 3.25 1.71 3.25 0.00 .081 O07/20/98 14:50 rcs
705 LATEX 3.25 1.64 3.25 0.00 .061 O07/20/98 14:51 rcs
706 BACKGROUND .035 .009 .035 0.00 .027 O07/20/98 14:53 rcs
r 707 1912696001 7.96 8.21 7.96 3.33 9.54 89.8 14.8 C07/20/98 14:57 rcs
708 1911187621 8.10 8.23 8.10 3.29 9.94 90.5 15.4 C07/20/98 14:57 rcs
r 709 1912395001 6.88 7.75 6.88 3.77 11.5 91.9 13.1 C07/20/98 14:58 rcs
710 1910851733 9.53 9.91 9.53 3.77 10.7 85.8 16.4 C07/20/98 14:59 rcs
711 BACKGROUND .013 .013 .013 .001 .027 O07/20/98 15:47 rcs

Seq Specimen ID WBC WIC WOC RBC HGB MCV RDW Date Time Op

EDIT DISPLAY FIND REJECT CUSTOMIZE TRANSMIT PRINT MAIN


ID SPECIMEN SPECIMEN FROM X-B DATA LOG DATA DATA LOG

Figure 5.44: Data Log Search Screen

FIND The [FIND SPECIMEN] key on the DATA LOG screen is used to locate a
SPECIMEN particular record by entering the sequence number, specimen ID
number, or patient name for the desired record. When this key is
pressed, the DATA LOG SEARCH screen is displayed. (See the
preceding figure.) If the record is not found in the Data Log, the
Bulletin Line displays the message NO ENTRY FOUND.

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Chapter 5 Using The Data Log

Reject From X-B/Accept Into X-B Soft Key


REJECT The letter b, r, or w will appear to the left of the sequence number
FROM X-B for certain samples.
ACCEPT
INTO X-B b – Specimen is included in both X-B WBC and X-B RBC
Analysis
r – Specimen is included in X-B RBC Analysis
w – Specimen is included in X-B WBC Analysis
If the cursor is positioned at a sample identified with a b, r, or w
preceding the sequence number (indicating that the results are
included in the X-B Analysis), the [REJECT FROM X-B] key label is
displayed on the DATA LOG screen. (See the preceding figure.) When
the [REJECT FROM X-B] key is pressed, the sample is marked with an
R located on the right side of the specimen ID. The results are
excluded from the X-B Analysis (the b, r, or w is deleted) and the
key label changes to [ACCEPT INTO X-B]. (See the following figure.)

If the [ACCEPT INTO X-B] key is pressed, the R is deleted, a b, r, or w


is displayed, and results are now included in the X-B Analysis.

DATA LOG Dec 21 1998 15:56


Ready Operator ID rcs
USE < OR > FOR MORE DATA Sequence # 0711

Seq Specimen ID WBC WIC WOC RBC HGB MCV RDW Date Time Op
700 BACKGROUND .006 .006 .006 0.00 .027 O12/20/98 14:38 rcs
b 701 1911937231 9.42 9.89 9.42 3.76 10.1 82.0 16.8 C12/20/98 14:42 rcs
r 702 1911359331 5.52 6.44 5.52 3.88 10.2 81.4 13.3 C12/20/98 14:43 rcs
703 1911883246 11.4 11.9 11.4 10.1 K12/20/98 14:43 rcs
704 LATEX 3.25 1.71 3.25 0.00 .081 O12/20/98 14:50 rcs
705 LATEX 3.25 1.64 3.25 0.00 .061 O12/20/98 14:51 rcs
706 BACKGROUND .035 .009 .035 0.00 .027 O12/20/98 14:53 rcs
r 707 1912696001 7.96 8.21 7.96 3.33 9.54 89.8 14.8 C12/20/98 14:57 rcs
708 1911187621 R 8.10 8.23 8.10 3.29 9.94 90.5 15.4 C12/20/98 14:57 rcs
r 709 1912395001 6.88 7.75 6.88 3.77 11.5 91.9 13.1 C12/20/98 14:58 rcs
710 1910851733 R 9.53 9.91 9.53 3.77 10.7 85.8 16.4 C12/20/98 14:59 rcs
711 BACKGROUND .013 .013 .013 .001 .027 O12/20/98 15:47 rcs

Seq Specimen ID WBC WIC WOC RBC HGB MCV RDW Date Time Op
Auto-Sampler Pause
EDIT DISPLAY FIND REJECT CUSTOMIZE TRANSMIT PRINT MAIN
ID SPECIMEN SPECIMEN FROM X-B DATA LOG DATA DATA LOG

Figure 5.45: Data Log Screen Showing Reject From X-B Key

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DATA LOG Dec 21 1998 15:56


Ready Operator ID rcs
USE < OR > FOR MORE DATA Sequence # 0711

Seq Specimen ID WBC WIC WOC RBC HGB MCV RDW Date Time Op
700 BACKGROUND .006 .006 .006 0.00 .027 O12/20/98 14:38 rcs
b 701 1911937231 9.42 9.89 9.42 3.76 10.1 82.0 16.8 C12/20/98 14:42 rcs
r 702 1911359331 5.52 6.44 5.52 3.88 10.2 81.4 13.3 C12/20/98 14:43 rcs
w 703 1911883246 11.4 11.9 11.4 10.1 K12/20/98 14:43 rcs
704 LATEX 3.25 1.71 3.25 0.00 .081 O12/20/98 14:50 rcs
705 LATEX 3.25 1.64 3.25 0.00 .061 O12/20/98 14:51 rcs
706 BACKGROUND .035 .009 .035 0.00 .027 O12/20/98 14:53 rcs
r 707 1912696001 7.96 8.21 7.96 3.33 9.54 89.8 14.8 C12/20/98 14:57 rcs
b 708 1911187621 R 8.10 8.23 8.10 3.29 9.94 90.5 15.4 C12/20/98 14:57 rcs
r 709 1912395001 6.88 7.75 6.88 3.77 11.5 91.9 13.1 C12/20/98 14:58 rcs
710 1910851733 R 9.53 9.91 9.53 3.77 10.7 85.8 16.4 C12/20/98 14:59 rcs
711 BACKGROUND .013 .013 .013 .001 .027 O12/20/98 15:47 rcs

Seq Specimen ID WBC WIC WOC RBC HGB MCV RDW Date Time Op
Auto-Sampler Pause
EDIT DISPLAY FIND ACCEPT CUSTOMIZE TRANSMIT PRINT MAIN
ID SPECIMEN SPECIMEN INTO X-B DATA LOG DATA DATA LOG

Figure 5.46: Data Log Screen Showing Accept Into X-B Key

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Customize Data Log Soft Key

CUSTOMIZE DISPLAY Dec 18 1998 10:29


Ready Operator ID sh
FOR DATA LOG Sequence # 0630

Group 1: WBC NEU LYM MONO EOS BASO

Group 2: RBC HGB HCT MCV MCH MCHC RDW

PLT MPV PCT PDW


Group 3:

WBC %N %L %M %E %B
Group 4:

WBC NEU LYM MONO EOS BASO


RBC HGB HCT MCV MCH MCHC RDW
PLT MPV PCT PDW
%N %L %M %E %B
RUT1 RUT2 RCT1 RCT2
WUT WCT WIC WOC EMPTY

SELECT STANDARD CUSTOMIZE RETURN


PARAMETER GROUPS PRINTOUT

Figure 5.47: Customize Display for Data Log Screen

CUSTOMIZE The [CUSTOMIZE DATA LOG] key on the DATA LOG screen is used to
DATA LOG customize the Data Log display. The CUSTOMIZE DISPLAY for Data
Log screen (see the preceding figure) and the following soft key
labels are displayed when the [CUSTOMIZE DATA LOG] key is pressed:
SELECT PARAMETER or
PLACE PARAMETER (This key label alternates between
these two selections.)
STANDARD GROUPS or
CUSTOM PLACEMENT (This key label alternates between
these two selections.)
CUSTOMIZE PRINTOUT
RETURN

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Using The Data Log Chapter 5

The CUSTOMIZE DISPLAY (for Data Log) screen displays a matrix


showing the four parameter groups and a list of the available
parameters. Parameter Group 1 is displayed (in the order indicated
from left to right) on the first DATA LOG screen. The remaining
groups are displayed on subsequent screens that are accessed by
pressing the Right arrow key on the keyboard. The Left arrow key
is used to page back through the screens to the first screen. Setting
up the CUSTOMIZE DISPLAY screen is discussed more fully later in
this section, in Data Log Set Up Procedures.

Select Parameter Soft Key


SELECT The [SELECT PARAMETER] key is used to select a parameter
PARAMETER designated by the cursor. When the key is pressed, the selected
PLACE parameter will be highlighted, the label will change to
PARAMETER
[PLACE PARAMETER], and a [CANCEL SELECTION] key will be
displayed. The [PLACE PARAMETER] key is used to display the
parameter in the location indicated by the position of the cursor.

Cancel Selection Soft Key


CANCEL The [CANCEL SELECTION] key is used to cancel the selection and
SELECTION display the [SELECT PARAMETER] key again.

Standard Groups Soft Key

CUSTOMIZE DISPLAY Dec 18 1998 10:29


Ready Operator ID sh
FOR DATA LOG Sequence # 0630

Group 1: WBC NEU LYM MONO EOS BASO

Group 2: RBC HGB HCT MCV MCH MCHC RDW

Group 3: PLT MPV PCT** PDW**

WBC %N %L %M %E %B
Group 4:

WBC NEU LYM MONO EOS BASO


RBC HGB HCT MCV MCH MCHC RDW
PLT MPV PCT PDW
%N %L %M %E %B
RUT1 RUT2 RCT1 RCT2
WUT WCT WIC WOC EMPTY

WBC RBC PLT DIFF CUSTOM CUSTOMIZE RETURN


GROUP GROUP GROUP GROUP PLACEMENT PRINTOUT

Figure 5.48: Customize Display Showing Standard Groups

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Predetermined groups of parameters, called Standard Groups,


STANDARD
GROUPS may be selected by pressing the [STANDARD GROUPS] key on the
CUSTOMIZE DISPLAY screen. The preceding figure shows the
CUSTOMIZE DISPLAY screen with the Standard Groups displayed.
The following soft key labels are displayed when the
[STANDARD GROUPS] key is pressed:
WBC GROUP
RBC GROUP
PLT GROUP
DIFF GROUP
CUSTOM PLACEMENT*
CUSTOMIZE PRINTOUT
RETURN
* The [CUSTOM PLACEMENT*] key is used to display the
CUSTOMIZE DISPLAY for Data Log screen for operator-selected
placement.
** Clinical significance has not been established for these
parameters. Therefore, they are not reportable in the U.S.
The preceding figure shows the WBC Group placed in GROUP 1,
the RBC Group placed in GROUP 2, the PLT Group placed in
GROUP 3, and the Diff Group placed in GROUP 4.
When each soft key is pressed, the designated parameter group
will be placed in the position indicated by the cursor.

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Using The Data Log Chapter 5

Customize Printout Soft Key

CUSTOMIZE PRINTOUT Dec 18 1998 10:31


Ready Operator ID sh
FOR DATA LOG Sequence # 0630

WBC %N %L %M %E %B RBC HGB HCT MCV MCH MCHC

RDW PLT MPV PCT PDW

WBC NEU LYM MONO EOS BASO


RBC HGB HCT MCV MCH MCHC RDW
PLT MPV PCT PDW
%N %L %M %E %B
RUT1 RUT2 RCT1 RCT2
WUT WCT WIC WOC

SELECT STANDARD RETURN


PARAMETER SELECTION

Figure 5.49: Customize Printout for Data Log Screen

CUSTOMIZE The [CUSTOMIZE PRINTOUT] key on the CUSTOMIZE DISPLAY for Data
PRINTOUT Log screen is used to customize the printout format of the Data
Log. (See the preceding figure.) The following soft key labels are
displayed when the [CUSTOMIZE PRINTOUT] key is pressed:
SELECT PARAMETER or
PLACE PARAMETER (This key label alternates between
these two selections.)
STANDARD SELECTION
RETURN
The CUSTOMIZE PRINTOUT for Data Log screen shows the order
(from left to right) in which the indicated parameters will be
printed. Procedures for Customizing the Data Log Printout are
included later in this section under Data Log Set Up Procedures.

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Select Parameter Soft Key


SELECT The [SELECT PARAMETER] key on the CUSTOMIZE PRINTOUT screen
PARAMETER is used to select a parameter designated by the cursor. When the
PLACE key is pressed, the selected parameter is highlighted, the label
PARAMETER
changes to [PLACE PARAMETER], and a [CANCEL SELECTION] key is
displayed. The [PLACE PARAMETER] key is used to display the
parameter in the location indicated by the position of the cursor.
CANCEL The [CANCEL SELECTION] key is used to cancel the selection and
SELECTION display the [SELECT PARAMETER] key again.

Standard Selection Soft Key


STANDARD The [STANDARD SELECTION] key on the CUSTOMIZE PRINTOUT for
SELECTION Data Log screen is used to configure the printout in the
predetermined print group shown in the preceding figure. When
the key is pressed, the print group will be changed to the Standard
Selection.

Return Soft Key


RETURN The [RETURN] key is used to return to the main DATA LOG screen.

Transmit Data Soft Key


TRANSMIT The [TRANSMIT DATA] key on the DATA LOG screen is used to
DATA transmit a record to a Laboratory Information System or on-line
computer. When the [TRANSMIT DATA] key is pressed, the screen
will prompt the operator to enter the starting and ending
sequence numbers (from the lowest to the highest) for the desired
transmission. Records may be transmitted singly or in batches as
designated by the sequence number(s).

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Using The Data Log Chapter 5

Print Data Log Soft Key


PRINT The [PRINT DATA LOG] key on the DATA LOG screen is used to print
DATA LOG the Data Log. When the [PRINT DATA LOG] key is pressed, the screen
prompts the operator to enter the starting and ending sequence
numbers (from the lowest to the highest) for the desired printout.
(See the following figure.) When the Enter key is pressed after the
sequence numbers have been entered, the screen will become a
DATA LOG screen for the record(s) and a time indicator will appear
in the upper right-hand corner to record the printing progress.

Starting Sequence #: 834 DATA LOG Dec 21 1998 16:33


Ending Sequence #: Ready Operator ID rcs
USE < OR > FOR MORE DATA Sequence # 0844

Seq Specimen ID WBC NEU LYM MONO EOS BASO Date Time Op
r 833 1912584436 3.83 2.30 .315 1.04 .012 .173 C12/21/98 14:40 rcs
r 834 1910952241 7.50 4.53 2.16 .563 .106 .141 C12/21/98 14:40 rcs
r 835 1912077932 .192 .052 .116 .012 .002 .010 C12/21/98 14:41 rcs
r 836 1911764321 6.26 4.99 .828 .252 .019 .176 C12/21/98 14:42 rcs
r 837 1911815501 4.37 2.75 .984 .519 .001 .116 C12/21/98 14:43 rcs
r 838 1911187621 7.07 6.02 .612 .218 .069 .150 C12/21/98 14:43 rcs
839 low ctrl 8.06 4.71 2.44 .621 .213 .074 O12/21/98 16:20 rcs
840 low ctrl 7.96 4.78 2.32 .601 .183 .080 O12/21/98 16:20 rcs
841 low ctrl 8.21 4.86 2.45 .598 .204 .099 O12/21/98 16:21 rcs
842 7.93 4.71 2.39 .557 .178 .092 K12/21/98 16:26 rcs
b 843 8.34 4.97 2.50 .551 .208 .114 O12/21/98 16:28 rcs
844 BACKGROUND .079 O12/21/98 16:30 rcs

Seq Specimen ID WBC NEU LYM MONO EOS BASO Date Time Op
Auto-Sampler Ready
EDIT DISPLAY FIND REJECT CUSTOMIZE TRANSMIT PRINT MAIN
ID SPECIMEN SPECIMEN FROM X-B DATA LOG DATA DATA LOG

Figure 5.50: Print Data Log Screen

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Chapter 5 Using The Data Log

Data Log Set Up Procedures


The Data Log may be configured to display and print results in the
order selected by the operator. This section gives instructions for
customizing the display and printout.

Customizing the Data Log Display


The CUSTOMIZE DISPLAY for Data Log screen displays a matrix
showing the four groups of parameters that will be consecutively
displayed on the four Data Log screens. (The following figure
shows the Standard Groups in the matrix.) A list of all available
parameters is displayed under the matrix. These parameters can be
selected from the list and placed in the desired group to customize
the display.

CUSTOMIZE DISPLAY Dec 21 1998 10:57


Ready Operator ID sh
FOR DATA LOG Sequence # 0630

Group 1: WBC NEU LYM MONO EOS BASO

Group 2: RBC HGB HCT MCV MCH MCHC RDW

Group 3: PLT MPV PCT* PDW*

WBC %N %L %M %E %B
Group 4:

WBC NEU LYM MONO EOS BASO


RBC HGB HCT MCV MCH MCHC RDW
PLT MPV PCT PDW
%N %L %M %E %B
RUT1 RUT2 RCT1 RCT2
WUT WCT WIC WOC EMPTY
Auto-Sampler Ready
SELECT STANDARD CUSTOMIZE RETURN
PARAMETER GROUPS PRINTOUT

Figure 5.51: Customize Display for Data Log Screen Showing Standard
Groups

* Clinical significance has not been established for these


parameters. Therefore, they are not reportable in the U.S.

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Using The Data Log Chapter 5

The display may be customized by selecting the individual


parameters, Standard Groups of parameters, or a combination of
the two. In addition to the usual hematologic parameters, the
following parameters may also be displayed in the Data Log:

RUT1 and RUT2 RUT1 is the RBC/PLT Upper Metering


Time. RUT2 is the RBC/PLT Upper
Metering Time for an extended
count.
RCT1 and RCT2 RCT1 is the RBC/PLT Count Time.
RCT2 is the RBC/PLT Count Time for
an extended count.
WUT WUT is the WIC Upper Metering
Time.
WCT WCT is the WIC Count Time.
WIC WIC is the WBC Impedance Count.
WOC WOC is the WBC Optical Count.
EMPTY An empty column is inserted in the
display.

Procedure: Customize Data Log Display


1. From the main DATA LOG screen, press the
[CUSTOMIZE DATA LOG] key to display the CUSTOMIZE DISPLAY
for Data Log screen.
2. If necessary, press the [CUSTOM PLACEMENT] key to display
the CUSTOMIZE DISPLAY for Data Log screen and key labels for
custom placement.
3. Use the arrow keys on the keyboard to move the cursor to the
desired parameter in the listing under the matrix.
4. Press the [SELECT PARAMETER] key. The selected parameter
highlights and the cursor will move to the first position in
Group 1.
NOTE: The key label changes to [PLACE PARAMETER] and a
[CANCEL SELECTION] key is displayed.

5. If necessary, use the arrow keys on the keyboard to move the


cursor to the desired location and press the
[PLACE PARAMETER] key.
NOTE: When the [PLACE PARAMETER] key is pressed, the
selected parameter will be displayed in the position
indicated by the cursor, and the cursor will then advance to
the next position in the group.

6. Repeat steps 3–5 until all selections have been made.

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7. To obtain a printout of the selected groups, press the Print


Screen key on the keyboard.
8. Press the [RETURN] key to return to the DATA LOG screen.
9. The Data Log will be displayed configured with the selected
parameters.

Standard Groups
The Data Log display may also be customized using
predetermined groups of parameters (Standard Groups) by
pressing the [STANDARD GROUPS] key on the CUSTOMIZE DISPLAY for
Data Log screen. The preceding figure shows the WBC Group
placed in GROUP 1, the RBC Group placed in GROUP 2, the PLT
Group placed in GROUP 3, and the Diff Group placed in GROUP 4.

Procedure: Standard Groups


1. From the main DATA LOG screen, press the
[CUSTOMIZE DATA LOG] key to display the CUSTOMIZE DISPLAY
for Data Log screen.
2. Press the [STANDARD GROUPS] key to display the
CUSTOMIZE DISPLAY for Data Log screen and key labels for
Standard Groups.
3. Use the arrow keys on the keyboard to move the cursor to the
desired group location (1–4).
NOTE: This number indicates the order in which the
group of parameters will be displayed (Group 1 on the first
screen, Group 2 on the second, etc.).

4. Press the soft key corresponding to the desired parameter


group. This group will be displayed in the position indicated
by the cursor position.
5. Repeat steps 3 and 4 until all desired groups have been
selected.
6. To obtain a printout of the configuration, press the Print
Screen key on the keyboard.
7. Press the [RETURN] key to return to the DATA LOG screen.
8. The Data Log is displayed configured with the Standard
Groups of parameters.

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Customizing the Printout

CUSTOMIZE PRINTOUT Jul 21 1998 11:00


Ready Operator ID sh
FOR DATA LOG Sequence # 0630

WBC WIC WOC %N %L %M %E %B RBC HGB HCT MCV

MCH MCHC RDW PLT MPV

WBC NEU LYM MONO EOS BASO


RBC HGB HCT MCV MCH MCHC RDW
PLT MPV PCT* PDW*
%N %L %M %E %B
RUT1 RUT2 RCT1 RCT2
WUT WCT WIC WOC

Auto-Sampler Ready
SELECT STANDARD RETURN
PARAMETER SELECTION

Figure 5.52: Customize Printout for Data Log Screen Showing Customized
Print Group

* Clinical significance has not been established for these


parameters. Therefore, they are not reportable in the U.S.

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The CUSTOMIZE PRINTOUT for Data Log screen (see the preceding
figure) shows the group of parameters that will be printed on a Data
Log printout. A list of the available parameters is displayed under
the group. The parameters can be selected from the list and placed
in the desired position to customize the printout. In addition to
the usual hematologic parameters, the following parameters can
also be printed in the Data Log:
RUT1 and RUT2 RUT1 is the RBC/PLT Upper Metering
Time. RUT2 is the RBC/PLT Upper
Metering Time for an extended count.
RCT1 and RCT2 RCT1 is the RBC/PLT Count Time.
RCT2 is the RBC/PLT Count Time for
an extended count.
WUT WUT is the WIC Upper Metering Time.
WCT WCT is the WIC Count Time.
WIC WIC is the WBC Impedance Count.
WOC WOC is the WBC Optical Count.

Procedure: Customize Data Log Printout


1. From the main DATA LOG screen, press the
[CUSTOMIZE DATA LOG] key followed by the [CUSTOMIZE
PRINTOUT] key.
2. Use the arrow keys on the keyboard to move the cursor to the
desired parameter in the list displayed under the printout group.
3. Press the [SELECT PARAMETER] key. The selected parameter
will be highlighted and the cursor will move to the first
position in the group.
NOTE: The key label will change to [PLACE PARAMETER]
and a [CANCEL SELECTION] key will be displayed.

4. If necessary, use the arrow keys on the keyboard to move the


cursor to the desired location and press the
[PLACE PARAMETER] key.
NOTE: When the [PLACE PARAMETER] key is pressed, the
selected parameter will be displayed in the position indicated
by the cursor and the cursor will then advance to the next
parameter in the list displayed under the printout group.

5. Repeat steps 2–4 until all selections have been made.


6. To obtain a printout of the configuration, press the Print
Screen key on the keyboard.
7. Press the [RETURN] key twice to return to the DATA LOG screen.

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Data Review from the Data Log


Scrolling Through the Data Log
The Page Up and Page Down keys on the keyboard may be used to
scroll rapidly through the records stored in the Data Log. Pressing
the Page Up key scrolls backward, and pressing the Page Down key
scrolls forward.

Displaying a Record
A copy of the RUN screen may be displayed for all 10,000 records
in the CELL-DYN 3700 System Data Log. A record is displayed by
positioning the cursor at the desired record in the Data Log listing
and pressing the [DISPLAY SPECIMEN] key. The Status Box indicates
DISPLAY SPECIMEN on results displayed (or printed) from the Data
Log record. (See the following figure.)

Spec ID ------------ 9742/B DISPLAY SPECIMEN Dec 18 1998 11:14


Patient ---------------- Ready Operator ID sh
Sex(M/F):- DOB:--/--/-- Sequence # 0630
Dr ---------------------- Sequence # 346 Closed Sampler
Param Set: 1 Limits: 1 SUSPECT
G
WBC 4.97 K/uL R
NEU 3.53 71.0 %N BANDS S A
LYM .813 16.4 %L I N
Z L
MONO .450 9.05 %M
E R
EOS .103 2.07 %E T
BASO .074 1.49 %B DFLT (NLMEB) Y
WCT:4.29
RBC 5.48 M/uL COMPLEXITY LOBULARITY
HGB 15.7 g/dL
HCT 58.2 % RBC MORPH
MCV 106. fL
MCH 28.7 pg
MCHC 27.0 g/dL
RDW 14.5 %

PLT 254. K/uL


MPV 8.38 fL RCT:6.09 PLT RBC

PREVIOUS NEXT EDIT CUSTOMIZE TRANSMIT PRINT PRINT RETURN


SPECIMEN SPECIMEN SPECIMEN REPORT SPECIMEN TICKET REPORT

Figure 5.53: Display Specimen Screen

Procedure: Record Display


1. From the MAIN MENU screen, press the [DATA LOG] key.
2. If the desired record is not displayed on the screen, press the
[FIND SPECIMEN] key to display the DATA LOG SEARCH screen.

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3. Use the arrow keys on the keyboard to move the cursor to the
desired identifier: sequence number, specimen ID number,
or name.
4. Type the appropriate information and press the Enter key on
the keyboard to start the search.
NOTE: If necessary, you may press the Escape (ESC) key or
the Enter key on the keyboard to exit from the search
function and return to the DATA LOG screen.

5. If the requested record is available, the screen will display the


Data Log page containing it. (The cursor will be located at
the sequence number of the record.)
6. Press the [DISPLAY SPECIMEN] key to display the RUN screen
for the selected record.
7. To obtain a printout, press the [PRINT REPORT] key.
NOTE: If color printing has been selected, the key label
will change to [COLOR PRINT] and a color printout will be
generated when the key is pressed.

8. The [PREVIOUS SPECIMEN] or [NEXT SPECIMEN] key may now


be used to display records listed in the Data Log which are
adjacent to the one currently displayed.

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Using The Data Log Chapter 5

Editing a Record
The Patient Demographics and the Parameter and Patient Limit
Sets may be edited for each record. (See the following figure.)

Spec ID ------------ 9742/B DISPLAY SPECIMEN Dec 18 1998 11:14


Patient ---------------- Ready Operator ID sh
Sex(M/F):- DOB:--/--/-- Sequence # 0630
Dr ---------------------- Sequence # 346 Closed Sampler
Param Set: 1 Limits: 1 SUSPECT
G
WBC 4.97 K/uL R
NEU 3.53 71.0 %N BANDS S A
LYM .813 16.4 %L I N
Z L
MONO .450 9.05 %M
E R
EOS .103 2.07 %E T
BASO .074 1.49 %B DFLT (NLMEB) Y
WCT:4.29
RBC 5.48 M/uL COMPLEXITY LOBULARITY
HGB 15.7 g/dL
HCT 58.2 % RBC MORPH
MCV 106. fL
MCH 28.7 pg
MCHC 27.0 g/dL
RDW 14.5 %

PLT 254. K/uL


MPV 8.38 fL RCT:6.09 PLT RBC
Press CONFIRM to save changes or CANCEL to cancel changes.
PREVIOUS NEXT EDIT CUSTOMIZE TRANSMIT PRINT PRINT RETURN
SPECIMEN SPECIMEN SPECIMEN REPORT SPECIMEN TICKET REPORT

Figure 5.54: Edit Specimen Screen

Procedure: Edit a Record


1. From the MAIN MENU screen, press the [DATA LOG] key.
2. Locate the desired record and press the [DISPLAY SPECIMEN]
key followed by the [EDIT SPECIMEN] key.
3. Use the arrow keys on the keyboard to move the cursor to the
line that will be edited, and type the appropriate information.
Press the Enter key on the keyboard to save the entry.
4. Press the [CONFIRM] key to display the RUN screen for the
edited result.
5. To obtain a printout, press the [PRINT REPORT] key or the
[COLOR PRINT] key.

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Chapter 5 References

References

1. International Committee for Standardization in


Haematology (ICSH). Protocol for Evaluation of Automated
Blood Cell Counters. Clinical and Laboratory Hematology.
1984; 6:69–84.
2. Clinical and Laboratory Standards Institute/NCCLS.
Procedures for the Collection of Diagnostic Blood Specimens by
Venipuncture; Approved Standard – Fifth Edition. CLSI/NCCLS
document H3-A5 (ISBN 1-56238-515-1) 940 West Valley Road,
Suite 1400, Wayne, PA 19087-1898, 2003.
3. Clinical and Laboratory Standards Institute/NCCLS.
Procedures and Devices for the Collection of Diagnostic
Capillary Blood Specimens; Approved Standard – Fifth Edition.
CLSI/NCCLS document H4-A5 (ISBN 1-56238-538-0) 940
West Valley Road, Suite 1400, Wayne, PA 19087-1898, 2004.

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Operating Instructions
References Chapter 5

NOTES

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Chapter 6 Calibration
Calibration

Overview

The CELL-DYN 3700 System is calibrated at the factory just prior


to shipment. An Abbott Field Service Representative will assist the
operator in confirming this calibration during instrument
installation. The instrument is very stable and should not require
frequent recalibration when it is operated and maintained
according to the recommendations in this manual.
The following parameters may be calibrated: WBC (WIC and
WOC), RBC, HGB, MCV, PLT and MPV.
This Overview contains the following subsections:
• When to Calibrate
• Open and Closed Modes
• Calibration Methods
• Calibration Materials
• Conventions Used in This Chapter

The rest of this chapter contains the following subsections:


• Calibration Procedural Summary
• Calibration Menus
• Pre-Calibration Procedures
• Auto-Cal Calibration
• Manual Calibration
• Mode-to-Mode Calibration
• WIC/WOC
• Post-Calibration Procedures

When to Calibrate
Scheduled calibration of the CELL-DYN 3700 System should
conform to the guidelines established by regulatory agencies.
Calibration should be confirmed by running controls on a regular
basis according to the requirements governing quality control in
your laboratory. In keeping with good laboratory practices, this
should include daily confirmation and following a reagent lot
number change.
Unscheduled calibration is indicated following service
adjustments performed by Abbott Field Service Representatives
such as major component changes.

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Overview Chapter 6

Unscheduled calibration is also necessary when indicated by the


results of the Quality Control program. However, calibration
should be considered as the very last step in a troubleshooting
sequence. Performing unnecessary calibrations may mask an
underlying problem with instrument performance.
On-board Quality Control programs are designed to provide
continual monitoring and verification of instrument calibration.
The laboratory should make the decision to recalibrate based on
the performance of the CELL-DYN 3700 System in these Quality
Control programs. The programs include (1) statistical
computations and Westgard Rules for commercial or patient
controls and (2) monitoring of patient samples for WBC
parameters with moving averages and RBC parameters using Bull’s
Moving Average Program (X-B).
Confirmation of calibration is also recommended following the
replacement of any major instrument component (for example,
the Shear Valve) that could affect calibration. Calibration may be
confirmed by running appropriate commercial controls or by
using fresh whole blood samples that were analyzed on a reliably
calibrated hematology analyzer or by reference methodology.

Open and Closed Modes


The CELL-DYN 3700 System has three modes of operation:
• Open Mode
• Closed Mode — Sample Loader version
• Closed Mode — Closed Sampler version
NOTE: Each CELL-DYN 3700 System has only one Closed
Mode of operation.

Both the Open and Closed Modes must be calibrated individually.


There are several ways to accomplish the total calibration,
depending only on the preference of the operator.

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Chapter 6 Overview

Calibration Methods
Two methods can be used to calibrate the CELL-DYN 3700 System:
• Auto-Cal is an automatic calibration program that is
incorporated into the Data Station software.
NOTE: Auto-Cal is available in the Open Mode only on
the CELL-DYN 3700SL System. Therefore, all references to
Closed Mode calibration with Auto-Cal pertain to the
CELL-DYN 3700CS System.

• Manual Calibration is an alternative to Auto-Cal calibration.


The instrument’s Open Mode is calibrated with the calibration
material of choice, using the method of choice. The Closed Mode
is then calibrated to match it, with fresh whole blood samples
using the Mode to Mode Calibration method of choice.

Calibration Materials
Two calibration materials can be used to calibrate the
CELL-DYN 3700 System:
• Commercial Calibrator
Calibration with CELL-DYN Calibrator is most efficiently
performed by calibrating the Open Mode. The Closed Mode
is then calibrated to match the Open Mode using fresh whole
blood samples.
• Fresh Whole Blood
Calibration with fresh whole blood is accomplished by
performing multiple analyses of each specimen by
acceptable reference methodology and calculating the mean
reference value for each parameter. The same specimens are
then analyzed on the CELL-DYN 3700 System in the Open
Mode. The Closed Mode is then calibrated to match the
Open Mode using another set of fresh whole blood
specimens. A detailed discussion of Reference Whole Blood
Calibration is given in the next section.

Commercial Calibrator Guidelines


For commercial calibrators, follow the directions given in the
package insert. Be certain to carefully read and follow directions
given for warming and mixing.

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Overview Chapter 6

Whole Blood Calibration Guidelines

Overview
Calibration with fresh whole blood samples is an alternative to
calibration with a commercial calibrator. Since specimens used in
place of a calibrator are ‘assayed’ by reference methods, this is
referred to as a Reference Whole Blood Calibration.
Fresh whole blood samples may also be used for an Instrument to
Instrument Calibration after each instrument has been
independently calibrated with a commercial calibrator or a
Reference Whole Blood Calibration.
The first part of this section gives the requirements for fresh
whole blood samples used for calibration. The second part
discusses the requirements for a Reference Whole Blood
Calibration and the reference methods that should be used. The
last part describes the requirements and procedure for an
Instrument to Instrument Calibration.

Requirements for Fresh Whole Blood Specimens


The following requirements should be observed for fresh whole
blood specimens used for calibration:
• The ICSH recommends that fresh specimens be less than four
hours old.1 Specimen age must not exceed eight hours at the
conclusion of the calibration procedure.
All parameter values should be within the laboratory’s normal
range. The following ranges are programmed for the reference
values that may be entered in the Auto-Cal program. Results
outside these limits cannot be entered.
WBC 1.99–25.0 K/µL (WIC and WOC)
RBC 2.00–6.50 M/µL
HGB 3.99–24.0 g/dL
MCV 70.0–100.0 fL
PLT 50.0–600.0 K/µL
• All cellular morphology must be normal.
• No known interfering substances should be present (for
example, lipemia, icterus, drugs).
• All specimens must be properly collected in tubes
containing the EDTA anticoagulant used by the laboratory.
• Each tube should contain at least 90% of the nominal
collection volume of blood.

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Calibration
Chapter 6 Overview

Requirements for Reference Whole Blood Calibration


Minimum requirements for a Reference Whole Blood Calibration
are described in the following list. Specimens used must meet the
requirements for fresh whole blood samples described earlier in
this section. Additional specimens and/or more repetitions of the
specimens may be used to achieve calibration accuracy beyond
CLSI/NCCLS recommendations.
1. A minimum of five specimens is required for adequate whole
blood calibration.
2. Specimens must be assayed at least in triplicate by reference
methodology and on the CELL-DYN 3700 System.
3. No more than two hours should elapse between the
CELL-DYN 3700 System run and the assay by reference
methodology. If specimens are run on the CELL-DYN 3700
System first, assay by reference methodology should be
completed within one hour. (Certain reference methodologies
are sensitive to RBC swelling caused by in vitro deoxygenation.)
4. Mean values should be calculated for each parameter for
each sample from the reference assay results. These mean
parameter values can then be entered in the Auto-Cal
program as reference values for each sample.
5. If Auto-Cal is not being used, the mean parameter values
should be averaged to obtain the cumulative mean value for
each parameter.
A worksheet is provided at the end of this section. This worksheet
may be used to assist with calculation of the reference mean
values and may be duplicated as needed.

Reference Methods
Reference values for a Reference Whole Blood Calibration should
be determined according to the following ICSH recommendations.

WBC, RBC, and PLT


Reference values for white blood cells, red blood cells, and
platelets may be determined using multiple counts from a
certified hemocytometer, from a counter that meters a fixed,
calibrated sample volume, or from a reliably calibrated
hematology analyzer.
NOTE: Enter the reference value for WBC as the WIC
reference value and enter the same value as the WOC
reference value.

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Overview Chapter 6

HGB
Reference values for hemoglobin may be determined using either
the reference cyanmethemoglobin method or a reliably calibrated
hemoglobinometer or hematology analyzer.
NOTE: DO NOT attempt to calibrate the CELL-DYN 3700
System with a hemoglobin standard designed for the
calibration of specific reference cyanmethemoglobin
methods. The instrument uses a modified
hemiglobincyanide or a modified
hemiglobinhydroxyalamine method which is not designed
to analyze these standards directly.

MCV
Reference values for the mean cell volume may be determined by
calculation from the reference microhematocrit and RBC
measurements or from multiple analyses on a reliably calibrated
hematology analyzer.
NOTE: Reference microhematocrit values may be
determined by multiple analyses using the CLSI/NCCLS
method for Packed Cell Volume (PCV).2 Use only plain
(non-anticoagulated) capillary tubes. Be certain to verify
the proper operation of the microhematocrit centrifuge
and the timer as recommended by CLSI/NCCLS.

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Calibration
Chapter 6 Overview

Instrument to Instrument Calibration


Specimens used for an Instrument to Instrument Calibration must
meet the requirements for fresh whole blood samples described
earlier in this section, except that specimens may be used within
6 hours of collection time. Sample age must not exceed 8 hours at
the completion of the procedure.
1. Select 10 samples that meet all requirements.
2. Confirm that the calibration of each instrument is
acceptable. It is preferable that Instrument to Instrument
Calibration be performed immediately after each instrument
is calibrated with the calibration material and method of
choice.
3. Choose one instrument to be the primary (reference)
instrument and designate the other instrument as the
secondary instrument. The secondary instrument will be
calibrated to match the primary instrument.
NOTE: It is suggested that Instrument to Instrument
Calibration be performed in the Open Mode on the
secondary instrument prior to performing the Mode to
Mode Calibration procedure.

4. Follow the directions in Manual Mode to Mode Calibration


(CS or SL), substituting the primary instrument for the Open
Mode and the secondary instrument for the Closed Mode.
5. Calibrate the Open Mode of the secondary instrument to
match the primary instrument.
6. After the Instrument to Instrument Calibration for the Open
Mode on the secondary instrument is confirmed, perform
the Mode to Mode Calibration on the instrument.

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Overview Chapter 6

NOTES

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Calibration
Chapter 6 Overview

Whole Blood Calibration Reference Values

Whole Blood Calibration Reference Values Worksheet


Date:___________________________________Parameter:_________________________________________

Technologist:____________________________Method:__________________________________________

___________________________________________________________________________________________

Reference Assays
Sample
ID 1 2 3 4 5 6 7 8 9 10 Mean

Cumulative Parameter Mean

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NOTES

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Chapter 6 Overview

Calibration Procedural Summary

Step Choices

1. Read appropriate overview • Auto-Cal Calibration


• Manual Calibration
• Mode to Mode Calibration
2. Complete Pre-Calibration Pre-Calibration Procedures Checklist
Procedures
3. Open Mode Calibration Choose ONE:
Procedures
• Auto-Cal Using Commercial
Calibrator
• Auto-Cal Using Fresh Whole Blood*
• Manual Calibration*
4. Closed Mode Calibration Choose ONE:
Procedures
• Auto-Cal Mode to Mode Calibration
for CELL-DYN 3700CS*
• Manual Mode to Mode Calibration
for CELL-DYN 3700SL or CS*
5. Complete Post-Calibration Complete both Quality Control and
Procedures Calibration Backup
* Be sure to read Calibration Materials, Whole Blood Calibration Guidelines within
the Overview of this chapter for complete information on fresh whole blood sample
requirements.

Conventions Used in this Chapter


A description of the conventions used in this chapter is given in
the Introduction in this manual.

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NOTES

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Calibration
Chapter 6 Calibration Menu

Calibration Menu

Calibration Menu Flowchart

CALIBRATION
Ready

ENTER CALIBRATN AUTO- CLOSED PRINT MAIN


FACTOR LOG CALIBRATE SAMPLER
OPEN
SAMPLER
RESTORE RESET ALL RETURN
FACTORS TO 1.000
WHOLE CALIBRATR MPV CHANGE RETURN
BLOOD LATEX SAMPLER
CLOSED PRINT RETURN (CS MODEL
SAMPLER LOG ONLY)
OPEN
SAMPLER

EDIT START CONTINUE QUIT CLEAR PRINT RETURN


REF VAL AUTO-CAL AUTO-CAL AUTO-CAL REF VALS SUMMARY

CONFIRM CANCEL
CLEAR CLEAR

CONFIRM CANCEL
QUIT QUIT

EDIT START CONTINUE QUIT CLEAR PRINT RETURN


REF VAL AUTO-CAL AUTO-CAL AUTO-CAL REF VALS SUMMARY

PREVIOUS NEXT REPEAT INTERRUPT QUIT ACCEPT PRINT RETURN


SPECIMEN SPECIMEN SPECIMEN AUTO-CAL AUTO-CAL MEANS
CONTINUE
AUTO-CAL
CONFIRM CANCEL
ACCEPT ACCEPT
CONFIRM CANCEL
REPEAT REPEAT

CONFIRM CANCEL
QUIT QUIT

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Calibration Screen

CALIBRATION Dec 20 1998 16:01


Ready Operator ID rcs
Sequence # 0711

Open Sampler
Open Sampler Calibration Factors:

Parameter Method Factor Date Time Operator


WOC ENTER FACTOR 1.054 12/20/98 14:15 rcs
WIC ENTER FACTOR 0.958 12/20/98 14:15 rcs
RBC ENTER FACTOR 0.841 12/20/98 14:15 rcs
HGB ENTER FACTOR 0.924 12/20/98 14:15 rcs
MCV ENTER FACTOR 0.878 12/20/98 14:15 rcs
PLT ENTER FACTOR 0.787 12/20/98 14:15 rcs
MPV FACTORY 1.000 --/--/-- --:-- ---

ENTER CALIBRATN AUTO- CLOSED PRINT MAIN


FACTOR LOG CALIBRATE SAMPLER

Figure 6.1: Calibration Screen Displaying Open Mode Calibration Factors

CALIBRA- The CALIBRATION screen is accessed from the MAIN MENU screen by
TION pressing the [CALIBRATION] key. The CALIBRATION screen displays
the current calibration factors for the mode indicated, the
calibration method used, the date and time the factors were
entered, and the operator ID.
The following soft key labels are displayed on the CALIBRATION
screen:
ENTER FACTOR
CALIBRATN LOG
AUTO-CALIBRATE
OPEN SAMPLER or
CLOSED SAMPLER (This key label alternates between
these two selections when the soft
key is pressed.)
PRINT
MAIN

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Chapter 6 Calibration Menu

The function of each key is discussed briefly in this section. The


Auto-Cal Calibration Procedures provide detailed instructions for
using the Auto-Cal program.

NOTE: For ease of explanation, the key labels may not


always be discussed in the order in which they appear on
the screen.

CALIBRATION Dec 20 1998 16:01


Ready Operator ID rcs
Sequence # 0711

Open Sampler
Closed Sampler Calibration Factors:

Parameter Method Factor Date Time Operator


WOC ENTER FACTOR 1.054 12/20/98 14:15 rcs
WIC ENTER FACTOR 0.958 12/20/98 14:15 rcs
RBC ENTER FACTOR 0.841 12/20/98 14:15 rcs
HGB ENTER FACTOR 0.924 12/20/98 14:15 rcs
MCV ENTER FACTOR 0.878 12/20/98 14:15 rcs
PLT ENTER FACTOR 0.787 12/20/98 14:15 rcs
MPV FACTORY 1.000 --/--/-- --:-- ---

ENTER CALIBRATN AUTO- OPEN PRINT MAIN


FACTOR LOG CALIBRATE SAMPLER

Figure 6.2: Calibration Menu Screen Displaying Closed Mode Calibration


Factors

Open Sampler/Closed Sampler Soft Key


OPEN The [OPEN SAMPLER/CLOSED SAMPLER] key is used to display the
SAMPLER current calibration factors for the mode selected (see the two
CLOSED preceding figures).
SAMPLER

NOTE: The key is labeled for the sampler mode that is


NOT currently displayed.

Print Soft Key


PRINT The [PRINT] key is used to print the Current Whole Blood Factors
displayed on the CALIBRATION screen.

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Main Soft Key


MAIN The [MAIN] key is used to return to the MAIN MENU screen.

Enter Factor Soft Key


ENTER The [ENTER FACTOR] key is used to display the ENTER CALIBRATION
FACTOR FACTOR screen showing the current Open and Closed Calibration
Factors (see the following figure). Calibration factors may be
changed on this screen by moving the cursor to the desired
position, typing the new factor, and pressing the Enter key on the
keyboard. The following soft key labels are displayed on this
screen:

RESTORE FACTORS
RESET ALL TO 1.000
RETURN

ENTER CALIBRATION FACTOR Dec 20 1998 16:01


Ready Operator ID rcs
Sequence # 0711

Open Sampler Closed Sampler


Parameter (Factor Range) Factor Factor
WOC (0.70…1.30) 1.008 1.056
WIC (0.70…1.30) 1.008 1.056
RBC (0.80…1.20) 1.071 1.060
HGB (0.70…1.30) 1.124 1.136
MCV (0.70…1.30) 0.985 0.985
PLT (0.70…1.30) 1.028 0.939
MPV (0.70…1.30) 1.000 1.000

RESTORE RESET ALL RETURN


FACTORS TO 1.000

Figure 6.3: Enter Calibration Factor Screen

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Restore Factors Soft Key


RESTORE The [RESTORE FACTORS] key is used to restore the previous
FACTORS calibration factors. This key is only active immediately after
factors have been changed.

Reset All to 1.000 Soft Key


RESET ALL The [RESET ALL TO 1.000] key is used to reset all of the calibration
TO 1.000 factors to 1.000.

Return Soft Key


RETURN The [RETURN] key is used to return to the CALIBRATION screen.

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Calibration Log Soft Key

CALIBRATION LOG Dec 20 1998 16:01


Ready Operator ID rcs
Sequence # 0711

Open Sampler
Open Sampler Calibration Log
Date Time OpID WOC WIC RBC HGB MCV PLT MPV
12/20/98 14:15 rcs 1.05(E) 0.96(E) 0.84(E) 0.92(E) 0.88(E) 0.79(E) 1.00(F)
Comments:

CLOSED PRINT RETURN


SAMPLER LOG

Figure 6.4: Calibration Log Screen

CALIBRATN The [CALIBRATN LOG] key is used to display the CALIBRATION LOG
LOG screen for the Open or Closed Mode. The following soft key labels
are displayed when the [CALIBRATN LOG] key is pressed:
OPEN SAMPLER or
CLOSED SAMPLER (This key label alternates between
these two selections.)
PRINT LOG
RETURN

Open Sampler/Closed Sampler Soft Key


OPEN The [OPEN SAMPLER/CLOSED SAMPLER] key is used to display the
SAMPLER calibration log for the selected mode.
CLOSED
SAMPLER NOTE: The key is labeled for the sampler mode that is
NOT currently displayed.

Print Log Soft Key


PRINT The [PRINT LOG] key is used to print the Calibration Log for the
LOG displayed mode.

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Return Soft Key


RETURN The [RETURN] key is used to return to the CALIBRATION screen.

Auto-Calibrate Soft Key

AUTO-CALIBRATION Dec 20 1998 16:03


Ready Operator ID rcs
Sequence # 0711

Open Sampler
Open sampler is selected. To calibrate using the
closed sampler (SL), refer to the manual mode to mode
calibration procedure given in the operator’s manual.

To proceed, press the key for the specimen type being


used (WHOLE BLOOD, CALIBRATR, or MPV LATEX).

WHOLE CALIBRATR MPV CHANGE RETURN


BLOOD LATEX SAMPLER

Figure 6.5: Auto-Calibration Screen for CELL-DYN 3700CS System

AUTO- The [AUTO-CALIBRATE] key is used to access the Auto-Calibration


CALIBRATE program. The AUTO-CALIBRATION screen and the following soft key
labels are displayed when this key is pressed:
WHOLE BLOOD
CALIBRATR
MPV LATEX
CHANGE SAMPLER (This key is available on the CELL-DYN
3700CS System only.)
RETURN
Change Sampler Soft Key
CHANGE The [CHANGE SAMPLER] key is used to change the Sample Aspiration
SAMPLER Mode of the Analyzer from the currently selected mode that is
indicated on the screen.
NOTE: This key is available on the CELL-DYN 3700CS
System only.

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Return Soft Key


RETURN The [RETURN] key is used to return to the CALIBRATION screen.

Whole Blood Soft Key

WHOLE BLOOD AUTO-CAL Dec 20 1998 16:01


Ready Operator ID rcs
Sequence # 0711

Open Sampler

Enter reference value for each parameter to be calibrated: (up to 10 specimens)


Spec ID RUNS WOC WIC RBC HGB MCV PLT
Min 1 1.99 1.99 2.00 3.99 70.0 50.0
Max 10 25.0 25.0 6.50 24.0 100. 600.
CAL#01 3 7.30 7.30 4.24 12.9 90.0 244.
CAL#02 3 ---- ---- ---- ---- ---- ----

EDIT START QUIT CLEAR PRINT RETURN


REF VAL AUTO-CAL AUTO-CAL REF VALS SUMMARY

Figure 6.6: Whole Blood Auto-Cal Screen

WHOLE The [WHOLE BLOOD] key is used to display the WHOLE BLOOD AUTO-
BLOOD CAL screen. This screen accesses the Auto-Cal program that is used
to calibrate the instrument with fresh whole blood samples. The
following soft key labels are displayed on this screen:

EDIT REF VAL


START AUTO-CAL
QUIT AUTO-CAL
CLEAR REF VALS
PRINT SUMMARY
RETURN

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Chapter 6 Calibration Menu

Edit Reference Value Soft Key


EDIT The [EDIT REF VAL] key is used to edit the displayed reference value
REF VAL indicated by the position of the cursor. The key deletes the existing
value and the cursor remains in position for the new entry.

Clear Reference Values Soft Key


CLEAR The [CLEAR REF VALS] key is used to delete the reference values
REF VALS that are currently displayed. The following soft key labels are
displayed when the [CLEAR REF VALS] key is pressed:

CONFIRM CLEAR
CANCEL CLEAR
These keys are used to confirm or cancel the Clear Reference
Values command.

Print Summary Soft Key


PRINT The [PRINT SUMMARY] key is used to print the entered reference
SUMMARY values.

Return Soft Key


RETURN The [RETURN] key is used to return to the AUTO-CALIBRATION screen.

Start Auto-Cal Soft Key


START The [START AUTO-CAL] key starts the Auto-Cal program by
AUTO-CAL initiating three background counts.

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Continue Auto-Cal Soft Key

WHOLE BLOOD AUTO-CAL Dec 20 1998 16:01


Ready for calibration Operator ID rcs
Sequence # 0711

Open Sampler

Enter reference value for each parameter to be calibrated: (up to 10 specimens)


Spec ID RUNS WOC WIC RBC HGB MCV PLT
Min 1 1.99 1.99 2.00 3.99 70.0 50.0
Max 10 25.0 25.0 6.50 24.0 100. 600.
CAL#01 3 7.30 7.30 4.24 12.9 90.0 244.
CAL#02 3 ---- ---- ---- ---- ---- ----

EDIT CONTINUE QUIT CLEAR PRINT RETURN


REF VAL AUTO-CAL AUTO-CAL REF VALS SUMMARY

Figure 6.7: Whole Blood Auto-Cal Screen

CONTINUE The [CONTINUE AUTO-CAL] key is displayed after the background


AUTO-CAL counts are completed. (See the preceding figure.)
INTERRUPT
AUTO-CAL
The key label changes to [INTERRUPT AUTO-CAL] after the key is
pressed.

The WHOLE BLOOD AUTO-CAL RESULTS screen (see the following


figure) and the following soft key labels are displayed when the
[CONTINUE AUTO-CAL] key is pressed:

INTERRUPT AUTO-CAL
QUIT AUTO-CAL
PRINT
RETURN

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Interrupt Auto-Cal Soft Key

SPEC ID CAL#01-01 WHOLE BLOOD AUTO-CAL Dec 20 1998 16:01


NO OF RUNS 331 Ready for Calibration Operator ID rcs
Sequence # 0711

Open Sampler
RESULTS FOR SPECIMEN #1
Spec 1 Mean Factor
Parameter Value RUN1 Factor Factor(1) %Diff
WOC 7.30 ---- ---- ---- ----
WIC 7.30 ---- ---- ---- ----
RBC 4.24 ---- ---- ---- ----
HGB 12.9 ---- ---- ---- ----
MCV 90.0 ---- ---- ---- ----
PLT 244. ---- ---- ---- ----

INTERRUPT QUIT PRINT RETURN


AUTO-CAL AUTO-CAL

Figure 6.8: Whole Blood Auto-Cal Results Screen

INTERRUPT The [INTERRUPT AUTO-CAL] key is used to interrupt (pause) the


AUTO-CAL Auto-Cal program.
CONTINUE
AUTO-CAL
Quit Auto-Cal Soft Key
QUIT The [QUIT AUTO-CAL] key is used to exit from the Auto-Cal
AUTO-CAL program before it is completed. When the [QUIT AUTO-CAL] key is
pressed, the Bulletin Line displays the message ALL EXISTING
DATA AND RESULTS WILL BE CLEARED. The following soft
key labels are displayed:
CONFIRM QUIT
CANCEL QUIT
These keys are used to confirm or cancel the Quit Auto-Cal
command.

Print Soft Key


PRINT The [PRINT] key is used to print the WHOLE BLOOD AUTO-CAL
RESULTS screen.

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Return Soft Key


RETURN The [RETURN] key is used to return to the REFERENCE VALUE ENTRY
screen.

Repeat Specimen Soft Key

SPEC ID CAL#01-01 WHOLE BLOOD AUTO-CAL Dec 20 1998 16:01


NO. OF RUNS 3 Ready for Calibration Operator ID rcs
Sequence # 0711

Open Sampler
RESULTS FOR SPECIMEN #1
Spec 1 Mean Factor
Parameter Value RUN1 RUN2 RUN3 Factor Factor(1) %Diff
WOC 7.30 7.42 ---- ---- 0.980 ---- ----
WIC 7.30 7.42 ---- ---- 0.980 ---- ----
RBC 4.24 4.39 ---- ---- 0.970 ---- ----
HGB 12.9 13.0 ---- ---- 0.990 ---- ----
MCV 90.0 91.0 ---- ---- 0.990 ---- ----
PLT 244. 254. ---- ---- 0.960 ---- ----

REPEAT INTERRUPT QUIT PRINT RETURN


SPECIMEN AUTO-CAL AUTO-CAL

Figure 6.9: Whole Blood Auto-Cal Results Screen with Results

REPEAT The [REPEAT SPECIMEN] key is displayed when the first run of the
SPECIMEN first specimen is completed (see the preceding figure). This key is
used to delete all results (runs) for the current specimen.
NOTE: This key deletes ALL RESULTS for ALL RUNS of the
current specimen. It does not delete one run only.

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Calibration
Chapter 6 Calibration Menu

Calibrator Soft Key

CALIBRATOR AUTO-CAL Dec 20 1998 16:01


Ready Operator ID rcs
Sequence # 0711

Open Sampler

Enter reference value for each parameter to be calibrated: (up to 10 specimens)


Spec ID Runs WOC WIC RBC HGB MCV PLT MPV
Min 1 4.59 4.59 3.00 10.0 85.0 150. 4.99
Max 10 10.2 10.2 5.50 15.5 97.0 400. 20.0
CAL#01 3 7.30 7.30 4.46 13.2 85.4 257. 8.00
CAL#02 3 ---- ---- ---- ---- ---- ----

EDIT START QUIT CLEAR PRINT RETURN


REF VAL AUTO-CAL AUTO-CAL REF VALS SUMMARY

Figure 6.10: Calibrator Auto-Cal Screen

CALIBRATR The [CALIBRATR] key is used to display the CALIBRATOR AUTO-CAL


screen (see the preceding figure). This screen accesses the Auto-Cal
program that is used to calibrate the instrument with a commercial
calibrator. The following soft key labels are displayed on this screen:
EDIT REF VAL
START AUTO-CAL
QUIT AUTO CAL
CLEAR REF VALS
PRINT SUMMARY
RETURN
These soft keys have the same functions as described for the
WHOLE BLOOD AUTO-CAL screen.
NOTE: If Auto-Cal was last performed with a calibrator,
the following key labels are displayed when the [WHOLE
BLOOD] key is pressed:
CONFIRM SELECTION
CANCEL SELECTION

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9140320C — November 2000
Calibration
Calibration Menu Chapter 6

These keys are used to confirm or cancel the Whole Blood


Auto-Cal selection. The Bulletin Line displays the
following message:
PRESS CONFIRM SELECTION TO CLEAR PREVIOUS
AUTO-CAL REFERENCE VALUES.

MPV Latex Soft Key

MPV LATEX AUTO-CAL Dec 20 1998 16:01


Ready Operator ID rcs
Sequence # 0711

Open Sampler

Enter latex reference value for MPV: (up to 10 specimens)


Spec ID RUNS MPV
Min 1 4.99
Max 10 20.0
CAL#01 3 7.30
CAL#02 3 ----

EDIT START QUIT CLEAR PRINT RETURN


REF VAL AUTO-CAL AUTO-CAL REF VALS SUMMARY

Figure 6.11: Latex Auto-Cal Screen

MPV The [MPV LATEX] key is used to display the MPV LATEX AUTO-CAL
LATEX screen (see the preceding figure).

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Calibration
Chapter 6 Pre-Calibration Procedures

Pre-Calibration Procedures

It is advisable to perform calibration at a time when it can be


completed without interruption. The Pre-Calibration procedures in
this section verify proper instrument performance to ensure a
successful calibration. These steps should be completed just prior to
beginning the calibration procedure itself. If problems are detected
during these checks, do not attempt to calibrate the instrument.
If necessary, call Abbott Diagnostics Customer Service for
assistance (at 1-877-4ABBOTT in the U.S.). After the problems have
been resolved, repeat the Pre-Calibration procedures to verify proper
performance.
The Pre-Calibration Procedures Checklist included in this section
may be duplicated as needed.

Calibration Guidelines
1. Always perform the daily, weekly, and monthly scheduled
maintenance as directed in Chapter 9: Maintenance before
calibrating the instrument. Instrument cleanliness is essential for
accurate calibration. Therefore, each laboratory should perform
any additional maintenance according to its requirements.
2. Use only recommended CELL-DYN reagents.
3. Verify the precision for the Open and Closed Modes prior to
calibration as directed in the Pre-Calibration Procedures
Checklist.
4. Precision should be verified for both WIC and WOC. This is
accomplished by configuring a QC file to display and print
both results.
NOTE: If necessary, refer to the directions for customizing
the display and printout of a QC file given in Chapter 5:
Operating Instructions, Subsection: Set-Up Instructions.
5. Select and process all whole blood samples according to the
requirements given in the Overview, Calibration Materials,
Whole Blood Calibration Guidelines within this chapter.
6. Be certain that any calibrator material is brought to room
temperature and mixed according to the manufacturer’s
instructions given in the package insert.
7. Be certain that the operator performing the calibration has
read and understands the information contained in the
package insert for the calibrator.
8. Be certain that the operator performing the calibration has
read and understands the calibration procedure(s).

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Calibration
Pre-Calibration Procedures Chapter 6

NOTES

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Calibration
Chapter 6 Pre-Calibration Procedures

CELL-DYN 3700 System


Pre-Calibration Procedures Checklist
Instrument:______________________________________ Date:_________________________________________
Operator: ______________________________________

1._______ Perform all required maintenance.


2._______ Verify that all reagent containers are at least 1/3 full.
3._______ Verify that the reagents have not reached the expiration date.
Diluent: Lot #____________ Exp. date _______
WIC/HGB Lyse: Lot #____________ Exp. date _______
Sheath Reagent: Lot #____________ Exp. date _______
Detergent: Lot #____________ Exp. date _______
4._______ If applicable, verify that the calibrator has not reached the expiration date.
Lot #____________ Exp. date _______
5._______ After the maintenance has been completed, verify that the background counts are within
the acceptable limits. Record the background counts below or attach a printout to this
document.
WIC <0.3 ________
WOC <0.3 ________
RBC <0.03 ________
HGB <0.2 ________
PLT <10.0 ________
6._______ Verify that the WIC Count Time is at the baseline value. Record the count time below.
WIC Count Time __________
7._______ Verify that the RBC Count Time is at the baseline value. Record the count time below.
RBC Count Time __________
8._______ From the DIAGNOSTICS MENU, obtain a printout of the VOLTAGE READINGS screen. Attach
the printout to these worksheets.
9._______ Prime the instrument with five normal whole blood samples that are less than eight hours
old.

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Calibration
Pre-Calibration Procedures Chapter 6

10.______ Confirm the Open Mode precision by analyzing a fresh, normal, whole blood sample 10
times in succession. Run the sample in an empty control file and record the CVs below or
attach a file printout to this document.
PARAMETER CV% LIMIT CV
WIC <2.8% ________
WOC <2.5% ________
RBC <1.5% ________
HGB <1.2% ________
MCV <1.0% ________
PLT <5.0% ________
11.______ a. CELL-DYN 3700SL System:
Confirm the Closed Mode precision of the Sample Loader by obtaining 15 mL of blood from
the same donor. Aliquot the blood into five 5-mL tubes that contain no anticoagulant. Run
each tube twice in succession. Run the samples in an empty control file and record the CVs
below or attach a file printout to this document.
PARAMETER CV% LIMIT CV
WIC <2.8% ________
WOC <2.5% ________
RBC <1.5% ________
HGB <1.2% ________
MCV <1.0% ________
PLT <5.0% ________
b. CELL-DYN 3700CS System:
Confirm the precision of the Closed Sampler by analyzing a fresh, normal, whole blood
sample 10 times in succession. Run the samples in an empty control file and record the
CVs below or attach a file printout to this document.
PARAMETER CV% LIMIT CV
WIC <2.8% ________
WOC <2.5% ________
RBC <1.5% ________
HGB <1.2% ________
MCV <1.0% ________
PLT <5.0% ________
12.______ If any problems are detected during the procedures outlined above, document them on
the following page.

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Calibration
Chapter 6 Pre-Calibration Procedures

Problems Detected
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________

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Calibration
Pre-Calibration Procedures Chapter 6

NOTES

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Calibration
Chapter 6 Auto-Cal Overview

Auto-Cal Overview

The Auto-Cal program provides an automated calibration method


that prepares the CELL-DYN 3700 System for calibration,
calculates new calibration factors, and calibrates the instrument.
The Auto-Cal program allows calibration with commercial
calibrators or whole blood samples. Auto-Cal may be performed in
either of the following two modes:
• Open Mode
• Closed Mode (CELL-DYN 3700CS System only)
On the CELL-DYN 3700SL System, Auto-Cal is available in the
Open Mode only. Therefore, all references to Closed Mode
calibration with Auto-Cal pertain to the CELL-DYN 3700CS System.

Some parameters may not need to be calibrated. Therefore, each


procedure includes specific criteria that are used to determine
which parameters require calibration. The criteria are:

• Validation Range — Calibration not required


• Calibration Limit — Do not calibrate, possible instrument
problem exists
• Calibration Range — Calibration is required
Complete instructions for using these criteria and a Calibration
Criteria Chart are included with each procedure to facilitate the
decision.
The calibration procedures have been divided into subsections that
consist of a series of easy-to-follow steps. Always follow the entire
procedure unless specifically directed to skip to another section.
Worksheets are provided at the end of each procedure to assist in
determining which parameters require calibration. For manual
calibration, worksheets can be used to assist in making the necessary
calculations. These worksheets can be duplicated as needed.
NOTE: Always complete the Pre-Calibration procedures
before beginning any calibration.

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Calibration
Auto-Cal Overview Chapter 6

Auto-Cal Sample Capacity


Auto-Cal accepts up to ten consecutive sample runs on up to ten
different samples as indicated in the following table.

Auto-Cal Program Sample Capacity


Specimen Specimen Maximum Number of Consecutive Runs
Type Limit Open Closed (Closed Sampler only)
Whole
Blood 10 10 5
Commercial
Calibrator 10 10 5

Auto-Cal Methodology
The Auto-Cal program automatically computes a calibration
factor based on all acceptable data. (New factors are calculated
using 1.000 as the reference.)
NOTE: Because the instrument uses 1.000 as the
reference, results generated in the Auto-Cal mode may not
correlate with results previously seen in the RUN mode.
This DOES NOT indicate a problem.

New calibration factors are computed for each parameter by


comparing each mean to the reference value entered for that
sample. If more than one sample is used, factors are computed for
each parameter from each of the samples. All of these factors are
averaged to obtain the final calibration factor for a given
parameter.
NOTE: When calibrating with whole blood, the reference
WBC value must be entered for WIC and WOC in order to
compute calibration factors for both parameters.

The program computes the percent difference between the


existing calibration factor and the new one it computed. The
operator either accepts or rejects the new factors based on the
calibration criteria listed in Table 6.1, Calibration Criteria Chart.

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Calibration
Chapter 6 Auto-Cal Overview

Calibration Requirements for Auto-Cal


The Open Mode should be calibrated with the CELL-DYN
Calibrator. The Closed Mode is then calibrated to match the Open
Mode using fresh, normal, whole blood samples. The following
requirements must be met in order to achieve an accurate
calibration. Additional samples and/or more repetitions of the
specimens may be used to achieve calibration accuracy beyond
CLSI/NCCLS recommendations.

• Calibrator Calibration
The Calibrator should be cycled for a minimum of 6 and a
maximum of 10 consecutive runs in the Open Mode. In
order to most efficiently use the Auto-Cal program, it is
suggested that the calibrator be cycled for nine consecutive
runs as if it were three separate calibrators. This is
accomplished by entering three for the number of runs for
each ‘calibrator’ and entering the assay value three times.
NOTE: For parameters with assigned values that exceed
the Auto-Calibration pre-set entry limits, use the manual
method for calibration.

• Whole Blood Calibration


At least five different, fresh, normal whole blood specimens
should be used. Each sample must be cycled for a minimum
of three consecutive runs. Whole blood samples may be run
in the Open or Closed Mode.
NOTE: Refer to Overview, Calibration Materials, Whole
Blood Calibration Guidelines within this chapter for
detailed instructions on performing a reference whole
blood calibration.

• Closed Mode Calibration (CS only)


Ten normal whole blood samples should be used. After the
Open Mode has been calibrated, each sample is cycled once
in each mode. The results from these samples are then used
to calibrate the Closed Mode.
NOTE: Complete directions for calibration of the Closed
Mode are given in Mode to Mode Calibration within this
chapter.

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Calibration
Auto-Cal Overview Chapter 6

NOTES

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Calibration
Chapter 6 Auto-Cal Using Calibrator

Auto-Cal Using Calibrator

This calibration procedure has been divided into subsections that


consist of a series of easy-to-follow steps. Always follow the entire
procedure unless specifically directed to skip to another section.
NOTE: Before beginning this procedure, be sure to
perform the Pre-Calibration procedures and read Auto-Cal
Overview within this chapter.

Starting Auto-Cal
1. From the MAIN MENU screen, press the [CALIBRATION] key.
2. If necessary, press the [OPEN SAMPLER] key to display the
Open Sampler calibration factors.
3. To obtain a printout of the Open Sampler Calibration
Factors displayed on the screen, press the [PRINT] key.
NOTE: These calibration factors are retained in the Auto-Cal
Calibration Log until 10 entries have been made. As each
subsequent entry is made, the oldest existing entry will be
deleted.

4. Press the [AUTO-CALIBRATE] key to select the AUTO-


CALIBRATION screen.
5. If necessary, press the [CHANGE SAMPLER] key to select the
Open Mode.
6. Press the [CALIBRATR] key to select Calibrator Auto-Cal.

Entering the Reference Values


Enter the reference (assay) values for the calibrator as follows:
1. Delete the existing values. Press the [CLEAR REF VALS] key
followed by the [CONFIRM CLEAR] key.
2. Type the lot number of the calibrator in the <SPEC ID> field.
Press the Enter key on the keyboard to save the entry and
advance the cursor.

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Calibration
Auto-Cal Using Calibrator Chapter 6

3. Type the desired number in the <# OF RUNS> field. Press the Enter
key on the keyboard to save the entry and advance the cursor.
NOTE: The calibrator should be cycled for a minimum of
6 and a maximum of 10 consecutive runs in the Open Mode.
In order to most efficiently use the Auto-Cal program, it is
suggested that the calibrator be cycled for 9 consecutive
runs as if it were three separate calibrators. This is
accomplished by entering three for the number of runs for
each calibrator and entering the assay value three times.

4. Type the assay value for each parameter in the appropriate


parameter reference values field. Press the Enter key on the
keyboard after each entry to save the entry and advance the
cursor.
NOTE: For parameters with assigned values that exceed
the Auto-Calibration pre-set entry limits, use the manual
method for Calibration.
5. To obtain a printout of the reference values, press the [PRINT
SUMMARY] key.

Collecting the Calibration Data


1. Press the [START AUTO-CAL] key.
The instrument automatically performs three background
counts. The screen will display the following message on the
Bulletin Line: PREPARING ANALYZER FOR
CALIBRATION, PLEASE WAIT...
• If the data from the background counts are acceptable,
the displayed message will change to the following:
READY TO CALIBRATE. PUSH CONTINUE AUTO-CAL
KEY. START SAMPLES. Proceed to step 5.
• If the data from the background counts are unacceptable,
the displayed message will alternate between
BACKGROUND COUNTS EXCEED LIMITS. PERFORM
MAINTENANCE TO CLEAR BACKGROUND and READY
TO CALIBRATE. PUSH CONTINUE AUTO-CAL KEY.
START SAMPLES. Proceed to step 2.
2. Press the [QUIT AUTO-CAL] key followed by the [CONFIRM QUIT]
key to exit Auto-Cal.
3. Check the background results and troubleshoot out-of-range
parameters.
4. When the problem has been resolved, return to the
CALIBRATION screen and press the [AUTO-CALIBRATE] key
followed by the [CALBRATR] key and the [START AUTO-CAL] key.
NOTE: The information entered in steps 2–4 of Entering
the Reference Values is retained.

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Calibration
Chapter 6 Auto-Cal Using Calibrator

5. When the background results are acceptable, press the


[CONTINUE AUTO-CAL] key.
6. Prepare the calibrator for use according to the directions
given in the package insert. Be certain to carefully read and
follow directions given for warming and mixing.
7. Run the calibrator one time. The reference value, VALUE,
and the results of the analysis, RUN1, will be displayed on
the CALIBRATOR AUTO-CAL, RESULTS FOR SPECIMEN (N) screen.
The Auto-Cal program automatically compares the results of
the first run of the calibrator with the Parameter Reference
Values entered for that specimen, to verify that the
difference is within acceptable limits.
• If the first run passes this internal Reference Check,
proceed to step 10.
• If the first run fails the Reference Check for any
parameter, the results are highlighted and the Bulletin
Line displays the following message: THIS RESULT IS
OUTSIDE THE ALLOWED LIMITS. REPEAT THIS
SPECIMEN. Proceed to step 8.
8. The run may be repeated at this time by pressing the [REPEAT
SPECIMEN] key followed by the [CONFIRM REPEAT] key. When
the repeat function is used, all the results for that specimen
will be automatically deleted.
• If the run passes the Reference Check, proceed to step 10.
• If the repeated run also fails the Reference Check, the
results will be highlighted and no calibration factor will
be calculated for that parameter. Proceed to step 9.
• If all parameters fail the Reference Check, results of that run
are not displayed and the Bulletin Line displays following
the message: ABANDON CAL FOR SPECIMEN 1 -
RESULT NOT INCLUDED IN MEAN. Proceed to step 9.
9. If necessary, repeat the run as directed in step 8.
• If the run passes the Reference Check, proceed to step 10.
• If all parameters on the repeated run also fail the
Reference Check, confirm that the reference values were
entered correctly. If the reference values are correct,
discard the calibrator vial. Obtain a new vial (be sure that it
is properly warmed and mixed) and repeat the procedure. If
all parameters fail again, call Abbott Diagnostics
Customer Service for assistance (at 1-877-4ABBOTT in the
U.S.).

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Calibration
Auto-Cal Using Calibrator Chapter 6

10. After a run has passed the internal Reference Check,


consecutively run the calibrator for the remaining runs.
Each subsequent run must pass the Reference Check and an
additional internal Precision Check. If a run fails either check,
the result for that parameter is highlighted and no calibration
factor will be calculated for the parameter. Calibration must
be repeated for the highlighted parameter. Calibration
factors will be calculated for the remaining parameters.
NOTE: Five runs are displayed on the screen. Press the Left
arrow key on the keyboard to view the first runs. Press the
Right arrow key on the keyboard to view the last runs.

Calibration Factor Calculation


As each run of the calibrator is completed, a calibration factor is
calculated and updated. This factor is displayed in the column
labeled SPEC (N) FACTOR.
The column labeled MEAN FACTOR (N) contains the average of the
calibration factors for each parameter for all of the calibrators
used in the calibration. The number after mean factor indicates
the number of calibrators used to compute that mean factor.
NOTE: If only one calibrator is used, the specimen factor
and the mean factor are the same.

The FACTOR % DIFF column displays the difference between the


calibration factor currently in the instrument and the mean factor
computed by the Auto-Cal program.
When all runs of the calibrator have been completed, the
following message will be displayed on the Bulletin Line:
TO UPDATE CURRENT CAL FACTORS WITH MEAN FACTORS
SHOWN ABOVE, PRESS THE [ACCEPT MEANS] KEY.
1. To obtain a printout of the SPEC and MEAN FACTORS and the
FACTOR % DIFF, press the [PRINT] key.
NOTE: Once this screen is exited, these resuls are no
longer available for review or printout.

2. Enter the factor % difference for each parameter in the Auto-Cal


Calibration Criteria Worksheet provided at the end of this
procedure. (This worksheet may be duplicated as needed.)
The calibration criteria are depicted in the following table.
NOTE: Delete the sign of the Factor % Diff value before
entering it on the worksheet.

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Calibration
Chapter 6 Auto-Cal Using Calibrator

3. To determine which parameters require calibration, continue


with the next section in this chapter, Determining Which
Parameters Need Calibration.

Table 6.1: Calibration Criteria


Calibration Criteria
Validation Range Calibration Range Calibration Limit
(Cal Not Required) (Cal Required) (Do Not Cal)
WOC <1.5% >1.5% but <10% >10%
WIC <1.5% >1.5% but <10% >10%
RBC <1.0% >1.0% but <10% >10%
HGB <1.0% >1.0% but <10% >10%
MCV <1.0% >1.0% but <10% >10%
PLT <3.0% >3.0% but <15% >15%

Determining Which Parameters Need Calibration


Validation Range
If the factor % difference is equal to or less than the following
values, then calibration is not required for that parameter because
the value is within the Validation Range.
Results equal to or less than the Validation Range:
WIC/WOC <1.5%
RBC <1.0%
HGB <1.0%
MCV <1.0%
PLT <3.0%
If the results for all parameters are less than the values given above,
press the [QUIT AUTO-CAL] key followed by the [CONFIRM QUIT] key.
If desired, the Calibrator Auto-Cal Calibration results may be
documented in the Auto-Cal Calibration Log. The Auto-Cal
Calibration Log is available for comments only when a calibration
factor is changed or reentered. Therefore, to document the
calibration in the <COMMENTS> line, access the log as follows.
1. From the CALIBRATION screen press the [ENTER FACTOR] key.
2. Retype any existing Cal Factor. Ensure that the cursor is in
the <Open Sampler Factor> column. Press the Enter key on the
keyboard to save the entry and advance the cursor.

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Calibration
Auto-Cal Using Calibrator Chapter 6

3. Press the [RETURN] key.


4. When the CALIBRATION LOG screen is displayed, indicate in
the <COMMENTS> line that instrument calibration was
confirmed and no changes were required. Press the Enter key
on the keyboard to save the entry and advance the cursor.
5. Be certain to retain all necessary documentation in the
instrument logbook.

Calibration Limit
If the factor % difference for a particular parameter is greater than
the following value, the value has exceeded the Calibration Limit
and there may be an instrument problem.
Results greater than the Calibration Limit:
WIC/WOC >10%
RBC >10%
HGB >10%
MCV >10%
PLT >15%
1. Check to see if any component that could affect the
calibration was changed, as this could cause the factor %
difference to exceed the above limits. For example:
Shear Valve RBC/PLT Transducer
WOC Flow Cell RBC/PLT Aperture Plate
WIC Transducer Hemoglobin Flow Cell
WIC Aperture Plate Syringe(s)

• If a component has been changed, then calibrate the


instrument as needed according to the directions in this
procedure.
• If no components have been changed and the factor %
difference exceeds these limits, do not calibrate. Confirm
that all Pre-Calibration procedures were completed, and
then call Abbott Diagnostics Customer Service for
assistance (at 1-877-4ABBOTT in the U.S.).
2. Press the [QUIT AUTO-CAL] key followed by the [CONFIRM QUIT]
key to exit Auto-Cal.
3. Troubleshoot accordingly. Be certain to retain all necessary
documentation in the instrument logbook.

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Chapter 6 Auto-Cal Using Calibrator

Calibration Range
If the factor % difference falls within the following Calibration Range,
calibration is required for that parameter. That is, a new calibration
factor must be entered. Calibrate the Open Mode as directed in
this procedure, either for all parameters or for specific parameters.
Results within the Calibration Range:
WIC/WOC >1.5% but < 10%
RBC >1.0% but < 10%
HGB >1.0% but < 10%
MCV >1.0% but < 10%
PLT >3.0% but < 15%
If all parameters require calibration, continue with the next
section in this procedure, Calibrating All Parameters. If only
specific parameters require calibration, skip to Calibrating
Individual Parameters within this chapter.

Calibrating All Parameters


If the factor % difference for all parameters falls within the
acceptable Calibration Range limits, perform this procedure.
1. Be certain that all desired printouts have been made.
2. Press the [ACCEPT MEANS] key.
The following message will be displayed on the Bulletin Line:
ALL DATA AND RESULTS WILL BE DELETED
3. Press the [CONFIRM ACCEPT] key to save the mean factors and
complete the Auto-Cal Procedure.
The CALIBRATION LOG screen will be automatically displayed.
NOTE: The log holds 10 entries. (The screen displays five
entries. To display the other five, press the Page Up key on
the keyboard.) When the log is full, subsequent entries will
cause the oldest entry to be deleted and the remaining entries
to move up one line so that the current factors will be
added to the bottom of the list. Therefore, the log should
be printed periodically for purposes of documentation.
The log displays the date, time, operator ID, calibration
factors, and a line for comments.
NOTE: The letters in parentheses after each factor indicate
the method of factor derivation: A = Auto-Cal, F = Factory,
E = Enter Factor (manual factor entry).

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Auto-Cal Using Calibrator Chapter 6

4. Type any comments in the <COMMENTS> field. Press the Enter


key on the keyboard to save the entry and advance the cursor.
NOTE: Comments may be added to the Calibration Log
only after a calibration factor is changed or reentered.

5. To obtain a printout of the Calibration Log for


documentation, press the [PRINT LOG] key.

Calibrating Individual Parameters


If only certain individual parameters require calibration, perform
this procedure.
1. Press the [QUIT AUTO-CAL] key followed by the [CONFIRM QUIT]
key to exit Auto-Cal.
2. Press the [RETURN] key twice to display the CALIBRATION
screen.
3. Press the [ENTER FACTOR] key to display the ENTER
CALIBRATION FACTOR screen.
4. Type any mean factors computed by Auto-Cal for those
parameters that require calibration in the appropriate fields.
(Refer to the printout made in step 1 of the Calibration
Factor Calculation section of this chapter.) Move the cursor
to the desired position, type the factor, and press the Enter
key on the keyboard to save the entry and advance the cursor.
5. Press the [RETURN] key.
6. When the CALIBRATION LOG screen is displayed, indicate the
parameters that required calibration in the <COMMENTS> line.
Press the Enter key on the keyboard to save the entry and
advance the cursor.
NOTE: Manually entered factors are followed by the letter
E in parentheses to indicate “Enter Factor.”

7. To obtain a printout of the Calibration Log for


documentation, press the [PRINT LOG] key.

Completing Open Mode Calibration


1. Press the [RETURN] key to display the CALIBRATION screen.
2. Press the [MAIN] key to exit the CALIBRATION screen.
3. Confirm the calibration of the Open Mode by running
commercial controls as directed in Post-Calibration
Procedures within this chapter.

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Calibration
Chapter 6 Auto-Cal Using Calibrator

CELL-DYN® 3700 System


Auto-Cal Calibration Criteria Worksheet
Instrument: ___________________________________ Date: _______________________________________
Operator: _____________________________________
____________________________________________________________________________________________

Auto-Cal Calibration Criteria


Factor Validation Range Calibration Range Calibration Limit Cal?
%Diff* (Cal Not Required) (Cal Required) (Do Not Cal**) Y/N
WOC <1.5% >1.5% but <10% >10%
WIC <1.5% >1.5% but <10% >10%
RBC <1.0% >1.0% but <10% >10%
HGB <1.0% >1.0% but <10% >10%
MCV <1.0% >1.0% but <10% >10%
PLT <3.0% >3.0% but <15% >15%
* Delete the sign of the factor % difference before entering it on the worksheet.
** Do not calibrate. Call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the U.S.).

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Calibration
Auto-Cal Using Calibrator Chapter 6

NOTES

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Chapter 6 Calibration

Auto-Cal Using Whole Blood

This calibration procedure has been divided into subsections that


consist of a series of easy-to-follow steps. Always follow the entire
procedure unless specifically directed to skip to another section.

NOTE: Before beginning this procedure, be sure to


complete the Pre-Calibration procedures and read
Overview, Calibration Materials, Whole Blood
Calibration Guidelines and Auto-Cal Overview within
this chapter.

Starting Auto-Cal
1. From the MAIN MENU screen, press the [CALIBRATION] key.
2. If necessary, press the [OPEN SAMPLER] key to display the
Open Mode calibration factors.
3. To obtain a printout of the Open Mode Calibration Factors
displayed on the screen, press the [PRINT] key.
NOTE: These calibration factors are retained in the Auto-Cal
Calibration Log until 10 entries have been made. As each
subsequent entry is made, the oldest existing entry is
deleted.

4. Press the [AUTO-CALIBRATE] key to select the AUTO-CALIBRATION


screen.
5. If necessary, press the [CHANGE SAMPLER] key to select the
Open Mode. (CS Mode only)
6. Press the [WHOLE BLOOD] key to select Whole Blood Auto-Cal.

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Calibration
Auto-Cal Using Whole Blood Chapter 6

Entering the Reference Values


Enter the reference values for the whole blood samples as follows:

1. Delete any existing values. Press the [CLEAR REF VALS] key
followed by the [CONFIRM CLEAR] key.
2. Type the appropriate information in the <SPEC ID> field, the
<# OF RUNS> field, and the parameter reference values field
for each whole blood sample to be used for the calibration.
Press the Enter key on the keyboard after each entry to save
it and advance the cursor.
NOTE: The <# OF RUNS> entered indicates the number of
times the sample will be consecutively cycled through the
instrument. Each sample may be run a maximum of 10
times.

3. To obtain a printout of the reference values, press the


[PRINT SUMMARY] key.

Collecting the Calibration Data


1. Press the [START AUTO-CAL] key.
The instrument automatically performs three background
counts. The screen will display the following message on the
Bulletin Line: PREPARING ANALYZER FOR CALIBRATION,
PLEASE WAIT...
• If the data from the background counts are acceptable,
the displayed message will change to the following:
READY TO CALIBRATE. PUSH CONTINUE AUTO-CAL
KEY. START SAMPLES. Proceed to step 5.
• If the data from the background counts are
unacceptable, the displayed message will alternate
between BACKGROUND COUNTS EXCEED LIMITS,
PERFORM MAINTENANCE TO CLEAR BACKGROUND and
READY TO CALIBRATE. PUSH CONTINUE AUTO-CAL
KEY. START SAMPLES. Proceed to step 2.
2. Press the [QUIT AUTO-CAL] key followed by the [CONFIRM
QUIT] key to exit Auto-Cal.
3. Check the background results and troubleshoot out-of-range
parameters.

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Chapter 6 Auto-Cal Using Whole Blood

4. When the problem has been resolved, return to the


CALIBRATION screen and press the [AUTO-CALIBRATE]
key followed by the [WHOLE BLOOD] key and the [START
AUTO-CAL] key.
NOTE: The information entered in step 2 of Entering the
Reference Values will be retained.

5. When the background results are acceptable, press the


[CONTINUE AUTO-CAL] key.
6. Run the first whole blood specimen one time. The reference
value, VALUE, and the results of the analysis, RUN1, will be
displayed on the WHOLE BLOOD AUTO-CAL, RESULTS FOR
SPECIMEN (N) screen.
The Auto-Cal program automatically compares the results of
the first run of each whole blood specimen with the
Parameter Reference Values entered for that specimen, to
verify that the difference is within acceptable limits.
• If the first run passes this internal Reference Check,
proceed to step 9.
• If the first run fails the Reference Check for any
parameter, the results are highlighted and the Bulletin
Line displays the following message: THIS RESULT IS
OUTSIDE THE ALLOWED LIMITS. RERUN THIS
SPECIMEN. Proceed to step 7.
7. The specimen may be repeated at this time by pressing the
[REPEAT SPECIMEN] key followed by the [CONFIRM REPEAT]
key. When the repeat function is used, all the results for that
specimen will be automatically deleted.
• If the run passes the Reference Check, proceed to step 9.
• If the repeated run also fails the Reference Check, the
results will be highlighted and no calibration factor will
be calculated for that parameter. Proceed to step 8.
• If all parameters fail the Reference Check, results of that
run are not displayed and the Bulletin Line displays the
following message: ABANDON CAL FOR SPECIMEN 1 -
RESULT NOT INCLUDED IN MEAN. Proceed to step 8.

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Calibration
Auto-Cal Using Whole Blood Chapter 6

8. If necessary, repeat the specimen as directed in step 7.


NOTE: Check to be sure the correct specimen was run
before repeating it.

• If the run passes the Reference Check, proceed to step 9.


• If all parameters on the repeated run also fail the
Reference Check, discard that sample and continue with
the next calibration sample. If desired, a replacement
sample may be added after the remaining samples have
been run.
9. After a run has passed the internal Reference Check, run
each sample for the number of runs entered in step 2 of
Entering the Reference Values.
Each subsequent run must pass the Reference Check and an
additional internal Precision Check. If a run fails either
check, the result for that parameter is highlighted and no
calibration factor will be calculated for the parameter.
Calibration must be repeated for the highlighted parameter.
Calibration factors will be calculated for the remaining
parameters.
10. When all runs of a sample have been completed, the
Bulletin Line displays the following message: NEW CAL
FACTOR COMPUTED. READY FOR NEXT CAL SPECIMEN.
11. Press the [NEXT SPECIMEN] key to run the next sample.

Calibration Factor Calculation


As each run of a whole blood sample is completed, a calibration
factor is calculated and updated. This factor is displayed in the
column labeled <SPEC (N) FACTOR>.
The column labeled <MEAN FACTOR (N)> contains the average of
the calibration factors for all whole blood samples used in the
calibration. The number in parentheses after mean factor indicates
the number of samples used to compute that mean factor.
The <FACTOR % DIFF> column displays the difference between the
calibration factor currently in the instrument and the mean
factor computed by the Auto-Cal program.
When all runs of all whole blood samples have been completed,
the following message is displayed on the Bulletin Line:
NEW CAL FACTOR COMPUTED – READY FOR ACCEPTANCE.

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Calibration
Chapter 6 Auto-Cal Using Whole Blood

1. Press the [PREVIOUS SPECIMEN] key and/or the [NEXT


SPECIMEN] key to review and/or print the results of all whole
blood samples that were analyzed.
NOTE: These results are only available for review and
printout before the [ACCEPT MEANS] key is pressed.

2. Press the [PRINT] key to obtain a printout of the SPEC and


MEAN FACTORS and the FACTOR % DIFF.
NOTE: Once this screen is exited, these results are no
longer available for review or printout.

3. Enter the factor % difference for each parameter in the


Auto-Cal Calibration Criteria Worksheet provided at the end
of this procedure. (This worksheet may be duplicated as
needed.) The calibration criteria are depicted in the
following table.
NOTE: Delete the sign of the factor % difference value
before entering it on the worksheet.

To determine which parameters require calibration, continue


with the next section in this chapter, Determining Which
Parameters Need Calibration.

Table 6.2: Calibration Criteria


Calibration Criteria
Validation Range Calibration Range Calibration Limit
Cal Not Required Cal Required Do Not Cal
WOC <1.5% >1.5% but <10% >10%
WIC <1.5% >1.5% but <10% >10%
RBC <1.0% >1.0% but <10% >10%
HGB <1.0% >1.0% but <10% >10%
MCV <1.0% >1.0% but <10% >10%
PLT <3.0% >3.0% but <15% >15%

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Calibration
Auto-Cal Using Whole Blood Chapter 6

Determining Which Parameters Need Calibration


Validation Range
If the factor % difference is equal to or less than the following
values, then calibration is not required for that parameter because
the value is within the Validation Range.
Results equal to or less than the Validation Range:
WIC/WOC <1.5%
RBC <1.0%
HGB <1.0%
MCV <1.0%
PLT <3.0%
If the results for all parameters are less than the values given above,
press the [QUIT AUTO-CAL] key followed by the [CONFIRM QUIT] key.
If desired, the Whole Blood Auto-Cal Calibration results may be
documented in the Auto-Cal Calibration Log. The Auto-Cal
Calibration Log is available for comments only when a calibration
factor is changed or reentered. Therefore, to document the
calibration in the <COMMENTS> line, access the log as follows.
1. From the CALIBRATION screen, press the [ENTER FACTOR] key.
2. Retype any existing Cal Factor. Ensure that the cursor is in
the <Open Sampler Factor> column. Press the Enter key on the
keyboard to save the entry and advance the cursor.
3. Press the [RETURN] key.
4. When the CALIBRATION LOG screen is displayed, indicate in
the <COMMENTS> line that instrument calibration was
confirmed and no changes were required. Press the Enter key
on the keyboard to save the entry and advance the cursor.
5. Be certain to retain all necessary documentation in the
instrument logbook.

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Calibration
Chapter 6 Auto-Cal Using Whole Blood

Calibration Limit
If the factor % difference for a particular parameter is greater than
the following value, as the value has exceeded the Calibration
Limit and there may be an instrument problem.
Results greater than the Calibration Limit:
WIC/WOC >10%
RBC >10%
HGB >10%
MCV >10%
PLT >15%
1. Check to see if any component that could affect the
calibration has been changed, as this could cause the factor
% difference to exceed the above limits. For example:
Shear Valve RBC/PLT Transducer
WOC Flow Cell RBC/PLT Aperture Plate
WIC Transducer Hemoglobin Flow Cell
WIC Aperture Plate Syringe(s)
• If a component has been changed, then calibrate the
instrument as needed according to the directions in this
procedure.
• If no components have been changed and the factor %
difference exceeds these limits, do not calibrate. Confirm
that all Pre-Calibration procedures were completed, and
then call Abbott Diagnostics Customer Service for
assistance (at 1-877-4ABBOTT in the US).
2. Press the [QUIT AUTO-CAL] key followed by the [CONFIRM
QUIT] key to exit Auto-Cal.
3. Troubleshoot accordingly. Be certain to retain all necessary
documentation in the instrument logbook.

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Calibration
Auto-Cal Using Whole Blood Chapter 6

Calibration Range
If the factor % difference falls within the following Calibration Range,
calibration is required for that parameter. That is, a new Calibration
Factor must be entered. Calibrate the Open Mode as directed in
this procedure, either for all parameters or for specific parameters.
Results within the Calibration Range:

WIC/WOC >1.5% but <10%


RBC >1.0% but <10%
HGB >1.0% but <10%
MCV >1.0% but <10%
PLT >3.0% but <15%
If all parameters require calibration, continue with the next
section in this chapter, Calibrating All Parameters. If only
specific parameters require calibration, skip to Calibrating
Individual Parameters within this chapter.

Calibrating All Parameters


If the factor % difference for all parameters falls within the
acceptable Calibration Range Limits, perform this procedure.
1. Be certain that all desired printouts have been made.
2. Press the [ACCEPT MEANS] key.
The following message is displayed on the Bulletin Line:
ALL DATA AND RESULTS WILL BE DELETED.
3. Press the [CONFIRM ACCEPT] key to save the mean factors and
complete the Auto-Cal procedure.
The CALIBRATION LOG screen is automatically displayed.
NOTE: The log holds 10 entries. (The screen displays five
entries. To display the other five, press the Page Up key on
the keyboard.) When the log is full, subsequent entries
cause the oldest entry to be deleted and the remaining
entries to move up one line so that the current factors are
added to the bottom of the list. Therefore, the log should
be printed periodically for purposes of documentation.
The log displays the date, time, operator ID, calibration
factors, and a line for comments.
NOTE: The letters in parentheses after each factor
indicate the method of factor derivation: A = Auto-Cal,
F = Factory, E = Enter Factor (manual factor entry).

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Calibration
Chapter 6 Auto-Cal Using Whole Blood

4. Type any comments in the <COMMENTS> field. Press the Enter


key on the keyboard to save the entry and advance the cursor.
NOTE: Comments may be added to the Calibration Log
only after a calibration factor is changed or reentered.
5. To obtain a printout of the Calibration Log for
documentation, press the [PRINT LOG] key.

Calibrating Individual Parameters


If only certain individual parameters require calibration, perform
this procedure.
1. Press the [QUIT AUTO-CAL] key followed by the [CONFIRM
QUIT] key to exit Auto-Cal.
2. Press the [RETURN] key twice to return to the CALIBRATION
screen.
3. Press the [ENTER FACTOR] key to display the ENTER
CALIBRATION FACTOR screen.
4. Type any mean factors computed by Auto-Cal for those
parameters that require calibration in the appropriate fields.
(Refer to the printout made in step 2 of the Calibration
Factor Calculation subsection of this procedure, Auto-Cal
Using Whole Blood.) Move the cursor to the desired
position, type the factor, and press the Enter key on the
keyboard to save the entry and advance the cursor.
5. Press the [RETURN] key.
6. When the CALIBRATION LOG screen is displayed, indicate the
parameters that required calibration in the <COMMENTS>
line. Press the Enter key on the keyboard to save the entry
and advance the cursor.
NOTE: Manually entered factors are followed by the
letter E in parentheses to indicate “Enter Factor.”

7. To obtain a printout of the Calibration Log for


documentation, press the [PRINT LOG] key.

Completing Whole Blood Open Mode Calibration


1. Press the [RETURN] key to return to the CALIBRATION screen.
2. Press the [MAIN] key to exit the CALIBRATION screen.
3. Confirm the calibration of the Open Mode by running
commercial controls as directed in Post-Calibration
Procedures within this chapter.

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Calibration
Auto-Cal Using Whole Blood Chapter 6

NOTES

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Calibration
Chapter 6 Auto-Cal Using Whole Blood

CELL-DYN 3700 System


Auto-Cal Calibration Criteria Worksheet
Instrument: ___________________________________ Date: _______________________________________
Operator: _____________________________________
____________________________________________________________________________________________

Auto-Cal Calibration Criteria


Factor Validation Range Calibration Range Calibration Limit Cal?
%Diff* (Cal Not Required) (Cal Required) (Do Not Cal**) Y/N
WOC <1.5% >1.5% but <10% >10%
WIC <1.5% >1.5% but <10% >10%
RBC <1.0% >1.0% but <10% >10%
HGB <1.0% >1.0% but <10% >10%
MCV <1.0% >1.0% but <10% >10%
PLT <3.0% >3.0% but <15% >15%
* Delete the sign of the factor % difference before entering it on the worksheet.
** Do not calibrate. Call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).

CELL-DYN® 3700 System Operator’s Manual 6-57


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Calibration
Auto-Cal Using Whole Blood Chapter 6

NOTES

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Chapter 6 Calibration

Manual Calibration Overview

The Open Mode of the CELL-DYN 3700 System may be calibrated


without using the Auto-Cal program. CELL-DYN Calibrator or
whole blood samples may be used for Manual Calibration. Whole
blood samples should meet the requirements outlined in
Overview, Calibration Materials, Whole Blood Calibration
Guidelines within this chapter.
Manual Calibration is accomplished by running the calibrator or
whole blood samples into a control file and using the parameter
means to manually compute the calibration factors. The new
calibration factors are then entered manually from the ENTER
FACTOR screen in the CALIBRATION menu.
NOTE: The QC files used for Manual Calibration should
be configured to display and print values for WIC and
WOC. If necessary, refer to the directions for customizing
display and printout given in Chapter 5: Operating
Instructions, Subsection: Set-Up Instructions.

Some parameters may not need to be calibrated. Therefore, each


procedure includes specific criteria that are used to determine
which parameters require calibration. The criteria are:

• Validation Range — Calibration not required


• Calibration Limit — Do not calibrate, possible instrument
problem exists
• Calibration Range — Calibration is required
Complete instructions for using these criteria and a Calibration
Criteria Chart are included with each procedure to facilitate the
decision.
The calibration procedures have been divided into subsections
that consist of a series of easy-to-follow steps. Always follow the
entire procedure unless specifically directed to skip to another
section.
Worksheets are provided at the end of each procedure to assist in
determining which parameters require calibration. For manual
calibration, worksheets can be used to assist in making the
necessary calculations. These worksheets can be duplicated as
needed.
NOTE: Always complete the Pre-Calibration procedures
before beginning any calibration.

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Calibration
Manual Calibration Overview Chapter 6

Guidelines
• The CELL-DYN Calibrator must be warmed and mixed
according to the directions given in the package insert and
run a minimum of six and a maximum of 10 times.
NOTE: For instructions on running the calibrator, refer to
Auto-Cal Overview, Calibration Requirements for
Auto-Cal within this chapter.

• If performing a reference whole blood calibration:


– A minimum of five different, fresh, whole blood
specimens must be used for this procedure.
– Each specimen must be assayed a minimum of three
times by reference methodology and on the CELL-DYN
3700 System.
– No more than two hours should elapse between the
reference run and the CELL-DYN 3700 System run.
NOTE: Refer to Overview, Calibration Materials, Whole
Blood Calibration Guidelines within this chapter for
detailed information about the requirements for reference
whole blood calibration.

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Chapter 6 Calibration

Manual Calibration Procedure — Open Mode

This calibration procedure has been divided into subsections that


consist of a series of easy-to-follow steps. Always follow the entire
procedure unless specifically directed to skip to another section.

NOTE: Before beginning this procedure, be sure to


complete the Pre-Calibration procedures and read
Overview, Calibration Materials, Whole Blood
Calibration Guidelines and Manual Calibration
Overview within this chapter.

Preparing for Manual Calibration


1. From the MAIN MENU screen, press the [CALIBRATION] key.
2. If necessary, press the [OPEN SAMPLER] key to display the
Open Sampler calibration factors.
3. Press the [PRINT] key to obtain a printout of the OPEN
SAMPLER CALIBRATION FACTORS displayed on the screen.
4. Press the [MAIN] key to return to the MAIN MENU screen.

Determining the Open Mode Mean


1. From the MAIN MENU screen, press the [RUN] key.
2. If necessary, press the [CHANGE SAMPLER] key to select the
Open Mode.
3. Press the [SPECIMEN TYPE] key.
4. Use the arrow keys on the keyboard to move the cursor to
an empty QC file and type “CD MEAN” in the <FILE NAME>
field.
5. Press the Enter key on the keyboard to save the name. Use
the Up arrow key on the keyboard to move the cursor back
into the “CD MEAN” file.
NOTE: The QC files used for Manual Calibration should
be configured to display and print values for WIC and
WOC. If necessary, refer to the directions for customizing
display and printout given in Chapter 5: Operating
Instructions, Subsection: Set Up Instructions.

6. Press the [QC SPECIMEN] key to return to the RUN screen.


7. Run each sample the appropriate number of times into the
“CD MEAN” QC file.

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Manual Calibration Procedure — Open Mode Chapter 6

NOTE: Ensure that the worklist is turned off before


running samples in QC file “CD Mean.”

8. Press the [MAIN] key followed by the [QUALITY CONTROL] key


and the [VIEW QC LOG] key.
9. To obtain a printout of the data, press the [PRINT QC LOG] key.
10. Press the [RETURN] key followed by the [MAIN] key to display
the MAIN MENU screen.

Calibration Factor Calculations


1. For the calibration factor calculations, use the mean value
for each parameter from the CD MEAN file printout and the
Current Open Mode Calibration Factor printout from step 3
of Preparing for Manual Calibration.
2. Enter the information from step 1 on the Manual Calibration
Worksheet provided at the end of this procedure (Manual
Calibration Procedure — Open Mode) to calculate the New
Open Mode Calibration Factor for each parameter as
follows. (This worksheet may be duplicated as needed.)
• Calibrator Calibration:
Assay Value
x Current Open Mode = New Open Mode
CELL-DYN Mean Cal Factor Cal Factor

• Reference Whole Blood Calibration:


Reference Mean
x Current Open Mode = New Open Mode
CELL-DYN Mean Cal Factor Cal Factor

3. Referring to the New Open Mode Cal Factor from the


previous step and the Current Open Mode Cal Factor from
the printout, use the appropriate chart on the worksheet to
compute the factor % difference as follows:

New Open Mode – Current Open


Cal Factor Mode Cal Factor x 100 = Factor % Difference
Current Open Mode
Cal Factor

4. Enter the factor % difference for each parameter in the


Manual Calibration Criteria chart on the Manual Calibration
Worksheet provided at the end of this procedure.

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Chapter 6 Manual Calibration Procedure — Open Mode

NOTE: Delete the sign of the factor % difference value


before entering it on the worksheet.

5. To determine which parameters require calibration,


continue with the next section in this chapter, Determining
Which Parameters Need Calibration.

Table 6.3: Calibration Criteria


Calibration Criteria
Validation Range Calibration Range Calibration Limit
(Cal Not Required) (Cal Required) (Do Not Cal)
WOC <1.5% >1.5% but <10% >10%
WIC <1.5% >1.5% but <10% >10%
RBC <1.0% >1.0% but <10% >10%
HGB <1.0% >1.0% but <10% >10%
MCV <1.0% >1.0% but <10% >10%
PLT <3.0% >3.0% but <15% >15%

Determining Which Parameters Need Calibration


Validation Range
If the factor % difference is equal to or less than the following
values, then calibration is not required for that parameter because
the value is within the Validation Range.
Results equal to or less than the Validation Range:
WIC/WOC <1.5%
RBC <1.0%
HGB <1.0%
MCV <1.0%
PLT <3.0%
If desired, the manual calibration results may be documented in
the Auto-Cal Calibration Log. The Auto-Cal Calibration Log is
available for comments only when a calibration factor is changed
or reentered. Therefore, to document the calibration in the
<COMMENTS> line, access the log as follows.
1. From the CALIBRATION screen press the [ENTER FACTOR] key.
2. Retype any existing Cal Factor. Ensure that the cursor is in
the <Open Sampler Factor> column. Press the Enter key on the
keyboard to save the entry and advance the cursor.
3. Press the [RETURN] key.

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Manual Calibration Procedure — Open Mode Chapter 6

4. When the CALIBRATION LOG screen is displayed, indicate in the


<COMMENTS> line that instrument calibration was confirmed
and no changes were required. Press the Enter key on the
keyboard to save the entry and advance the cursor.
5. Be certain to retain all necessary documentation in the
instrument logbook.

Calibration Limit
If the factor % difference for a particular parameter is greater than the
following value, there may be a computation error or an instrument
problem as the value has exceeded the Calibration Limit.
Results greater than the Calibration Limit:
WIC/WOC >10%
RBC >10%
HGB >10%
MCV >10%
PLT >15%
1. Recheck the numbers entered on the worksheet and then
recheck all calculations.
2. Check to see if any component has been changed that could
affect the calibration, as this could cause the factor %
difference to exceed the above limits. For example:
Shear Valve RBC/PLT Transducer
WOC Flow Cell RBC/PLT Aperture Plate
WIC Transducer Hemoglobin Flow Cell
WIC Aperture Plate Syringe(s)
• If a component has been changed, then calibrate the instrument
as needed according to the directions in this procedure.
• If no components have been changed, the calculations are
correct, and the factor % difference exceeds these limits, do
not calibrate. Confirm that all Pre-Calibration procedures
were completed, and then call Abbott Diagnostics Customer
Service for assistance (at 1-877-4ABBOTT in the US).

Calibration Range
If the factor % difference falls within the following Calibration
Range, calibration is required for that parameter. Calibrate the
Open Mode as directed in this procedure.

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Chapter 6 Manual Calibration Procedure — Open Mode

Results within the Calibration Range:


WIC/WOC >1.5% but <10%
RBC >1.0% but <10%
HGB >1.0% but <10%
MCV >1.0% but <10%
PLT >3.0% but <15%

Calibrating the Open Mode


1. From the MAIN MENU screen, press the [CALIBRATION] key.
2. Press the [ENTER FACTOR] key to display the ENTER
CALIBRATION FACTOR screen.
3. Type the New Open Mode Calibration Factors for the
parameters that require calibration into the appropriate
fields in the <OPEN SAMPLER> column. Move the cursor to
the desired position, type the factor, and press the Enter key
on the keyboard to save the factor and advance the cursor.
4. After the New Open Mode Calibration Factors have been
entered, press the [RETURN] key.
5. The CALIBRATION LOG screen is automatically displayed. The
log holds 10 entries. (The screen displays five entries. To
display the other five, press the Page Up key on the
keyboard.) When the log is full, subsequent entries cause
the oldest entry to be deleted and the remaining entries to
move up one line, so that the current factors are added to
the bottom of the list. Therefore, the log should be printed
periodically for purposes of documentation.
The log displays the date, time, operator ID, calibration
factors, and a line for comments.
NOTE: The letters in parentheses after each factor
indicate the method of factor derivation: A = Auto-Cal,
F = Factory, E = Enter Factor (manual factor entry).

6. Type any comments in the <COMMENTS> field. Press the Enter


key on the keyboard to save the entry and advance the cursor.
NOTE: Comments may be added to the Calibration Log
only after a calibration factor is changed or reentered.

7. To obtain a printout of the Calibration Log for


documentation, press the [PRINT LOG] key.

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Calibration
Manual Calibration Procedure — Open Mode Chapter 6

Completing Manual Calibration


1. Press the [RETURN] key twice to return to the CALIBRATION screen.
2. Press the [MAIN] key to exit the CALIBRATION screen.
3. Retain all necessary documentation in the instrument logbook.
4. Confirm the calibration of the Open Mode by running
commercial controls as directed in Post-Calibration
Procedures within this chapter.

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Chapter 6 Manual Calibration Procedure — Open Mode

NOTES

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Calibration
Manual Calibration Procedure — Open Mode Chapter 6

CELL-DYN 3700 System


Manual Calibration Worksheet
Instrument: ___________________________________ Date: _______________________________________
Operator: _____________________________________
____________________________________________________________________________________________
Calculate All Factors To Three Decimal Places

New Open Mode Calibration Factors

Assay or Ref Mean


x Current Open Mode Cal Factor* = New Open Mode Cal Factor
CELL-DYN Mean

Assay Value Current New


or Open Mode Open Mode Open Mode
Ref Mean / Mean x Cal Factor* = Cal Factor Range**
WOC / x = 0.700–1.300
WIC / x = 0.700–1.300
RBC / x = 0.800–1.200
HGB / x = 0.700–1.300
MCV / x = 0.700–1.300
PLT / x = 0.700–1.300
* Current factor as printed in this Manual Calibration procedure.
** If factor falls outside limits, do not calibrate. Check all calculations and call Abbott Diagnostics Customer Service for
assistance (at 1-877-4ABBOTT in the US).

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Calibration
Chapter 6 Manual Calibration Procedure — Open Mode

Factor % Difference

New Open Mode Factor – Current Open Mode Factor


Current Open Mode Factor x 100 = % Diff

New Current Current


Open Mode Open Mode Open Mode
Factor – Factor* / Factor x 100 = % Diff
WOC – / x 100 =
WIC – / x 100 =
RBC – / x 100 =
HGB – / x 100 =
MCV – / x 100 =
PLT – / x 100 =
* The Current Open Mode Factor is printed at the start of this calibration procedure.

Manual Calibration Criteria


Factor Validation Range Calibration Range Calibration Limit Cal?
%Diff* (Cal Not Required) (Cal Required) (Do Not Cal**) Y/N
WOC <1.5% >1.5% but <10% >10%
WIC <1.5% >1.5% but <10% >10%
RBC <1.0% >1.0% but <10% >10%
HGB <1.0% >1.0% but <10% >10%
MCV <1.0% >1.0% but <10% >10%
PLT <3.0% >3.0% but <15% >15%
* Delete the sign of the % Diff value before entering it in the chart.
** Do not calibrate. Call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).

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Manual Calibration Procedure — Open Mode Chapter 6

NOTES

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Chapter 6 Calibration

Mode To Mode Calibration Overview

The Open Mode of the CELL-DYN® 3700 System is calibrated with


either a commercial calibrator or fresh whole blood specimens.
The Closed Mode is calibrated to match the Open Mode using 10
different, fresh, normal whole blood specimens. Specimens used
for Mode to Mode calibration should meet the requirements
outlined in Overview, Calibration Materials, Whole Blood
Calibration Guidelines within this chapter.
Single runs of 10 specimens can be used because calibration
differences between modes are usually very small. Specimens may
be run more than once if desired, but specimens should be run
the same number of times in each mode. Calibration of the
Closed Mode with fewer than 10 specimens is not recommended
because it may introduce a bias between the modes.
Worksheets are provided within this section (at the end of each
procedure) to assist in determining which parameters require
calibration. For manual calibration, worksheets may be used to
assist in making the necessary calculations. These worksheets may
be duplicated as needed.

Auto-Cal Mode to Mode Calibration


Auto-Cal is not available for the Closed Mode on the CELL-DYN
3700SL System. Therefore, the Closed Mode on the CELL-DYN
3700SL System must be calibrated using the Manual Mode to
Mode procedure.
After the Open Mode has been calibrated, or Open Mode calibration
is confirmed, each specimen is run one time in the Open Mode. For
ease of identification, specimens should be run as patient specimens.
NOTE: The Data Log should be configured to display and
print values for WIC and WOC. If necessary, refer to the
directions for customizing display and printout given in
Chapter 5: Operating Instructions, Subsection: Using the
Data Log.

The Open Mode values for each sample are entered as the
reference values in the Auto-Cal program for the Closed Mode.
The samples are then run in the Closed Mode. The factor percent
difference computed by the Auto-Cal program is used to
determine which Closed Mode parameters require calibration.

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Mode To Mode Calibration Overview Chapter 6

Manual Mode to Mode Calibration


After the Open Mode has been calibrated, or Open Mode
calibration is confirmed, the samples are run into quality control
files in the Open and Closed Modes.

NOTE: The quality control files used for Manual


Calibration should be configured to display and print
values for WIC and WOC. If necessary, refer to the
directions for Customizing Display and Printout given in
the Set Up Instructions section of Chapter 5.

The automatically calculated parameter means from each mode


are used to manually compute the calibration bias and the new
calibration factors. The new calibration factors are then entered
manually from the ENTER FACTOR screen in the CALIBRATION menu.

Mode to Mode Calibration Preparation


1. Confirm the calibration of the Open Mode before calibrating
the Closed Mode.
2. Select 10 different fresh whole blood specimens that meet
the following requirements:
• Each specimen should have sufficient volume to be run
once in the Open Mode and twice in the Closed Mode.
Therefore, try to select full, 13 x 75 mm, 3-mL tubes.
• Specimens must be less than eight hours old at the
completion of the procedure. If possible, select
specimens that are less than four hours old.
• All parameter values should be within the laboratory’s
normal range.
3. Perform the Pre-Calibration Procedures outlined within this
chapter.

Closed Mode Calibration Confirmation


An optional confirmatory step is included at the end of the Mode to
Mode Calibration procedures which use whole blood specimens.
After Closed Mode calibration is completed, instructions are given
for rerunning the whole blood specimens that were used for
calibration. These “Post-Calibration results” are then used to
confirm the accuracy of the Closed Mode calibration. Closed Mode
calibration may also be confirmed by running commercial controls.
Either method is satisfactory for confirming the calibration.

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Chapter 6 Calibration

Mode To Mode Auto-Cal Calibration


(Closed Sampler Only)

The calibration procedure has been divided into subsections that


consist of a series of easy-to-follow steps. Always follow the entire
procedure unless specifically directed to skip to another section.
NOTE: Confirm the calibration of the Open Mode before
performing this procedure.

NOTE: Before beginning this procedure, be sure to


complete the Pre-Calibration procedures and read
Overview, Calibration Materials, Whole Blood
Calibration Guidelines and Mode to Mode Calibration
Overview within this chapter.

Determining Reference Values


The specimens used for the calibration should be run in the Open
Mode as patient specimens in order to properly identify them. A
printout of the Data Log for those sequence numbers can be used
to enter the reference values and may be retained for
documentation.

NOTE: The Data Log should be configured to display and


print values for WIC and WOC. If necessary, refer to the
directions for customizing display and printout given in
Chapter 5: Operating Instructions, Subsection: Using the
Data Log, Customize Data Log Soft Key.

1. From the MAIN MENU screen, press the [RUN] key.


2. If necessary, press the [CHANGE SAMPLER] key to select the
Open Mode.
3. Press the [SPECIMEN TYPE] key followed by the [PATIENT] key.
4. Type the specimen identification for the first specimen in
the <NEXT ID> field. Press the Enter key on the keyboard to
save the entry and advance the cursor. Run the sample,
noting the Sequence Number.
5. Repeat step 4 for each sample. Note the Sequence Number
of the last sample.
6. Access the Data Log. Press the [PRINT DATA LOG] key.
7. Type the range of Sequence Numbers for the calibration
samples in the indicated fields to obtain the printout.

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Starting Auto-Cal
1. From the MAIN MENU screen, press the [CALIBRATION] key.
2. If necessary, press the [CLOSED SAMPLER] key to display the
Closed Mode Calibration Factors.
3. To obtain a printout of the Closed Mode Calibration Factors
displayed on the screen, press the [PRINT] key.
NOTE: These calibration factors are retained in the Auto-Cal
Calibration Log until 10 entries have been made. As each
subsequent entry is made, the oldest existing entry will be
deleted.

4. Press the [AUTO-CALIBRATE] key to display the AUTO-


CALIBRATION screen.
5. If necessary, press the [CHANGE SAMPLER] key to select the
Closed Mode.
6. Press the [WHOLE BLOOD] key to select Whole Blood Auto-Cal.

Entering the Reference Values


Enter the reference values for the whole blood samples as follows:
1. Delete any existing values. Press the [CLEAR REF VALS] key
followed by the [CONFIRM CLEAR] key.
2. For each specimen used, type the appropriate information in
the <SPEC ID> field and the <RUNS> field. Press the Enter key on
the keyboard after each entry to save it and advance the cursor.
NOTE: The <RUNS> entered indicates the number of times
the specimen will be consecutively cycled through the
instrument. Each sample may be run a maximum of 5
times. For Mode to Mode Calibration, each specimen should
be run once but specimens may be run more than one
time if desired. However, specimens should be run the
same number of times in each mode.

3. Type the Open Mode value for each parameter in the


appropriate parameter reference values field. Press the Enter
key on the keyboard after each entry to save it and advance
the cursor.
4. To obtain a printout of the reference values, press the [PRINT
SUMMARY] key.

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Chapter 6 Mode To Mode Auto-Cal Calibration (Closed Sampler Only)

Collecting the Calibration Data


1. Press the [START AUTO-CAL] key.
The instrument automatically performs three background
counts. The screen will display the following message on the
Bulletin Line:
PREPARING ANALYZER FOR CALIBRATION,
PLEASE WAIT...
• If the data from the background counts are acceptable,
the displayed message will change to the following:
READY TO CALIBRATE. PUSH CONTINUE AUTO-CAL
KEY. START SAMPLES. Proceed to step 5.
• If the data from the background counts are unacceptable,
the displayed message will alternate between
BACKGROUND COUNTS EXCEED LIMITS. PERFORM
MAINTENANCE TO CLEAR BACKGROUND and READY
TO CALIBRATE. PUSH CONTINUE AUTO-CAL KEY.
START SAMPLES. Proceed to step 2.
2. Press the [QUIT AUTO-CAL] key followed by the [CONFIRM QUIT]
key to exit Auto-Cal.
3. Check the background results and troubleshoot out-of-range
parameters.
4. When the problem has been resolved, return to the CALIBRATION
screen and press the [AUTO-CALIBRATE] key followed by the
[WHOLE BLOOD] key and the [START AUTO-CAL] key.
NOTE: The information entered in steps 2 and 3 of
Entering the Reference Values will be retained.
5. When background results are acceptable, press the
[CONTINUE AUTO-CAL] key.

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Mode To Mode Auto-Cal Calibration (Closed Sampler Only) Chapter 6

6. Run the first whole blood specimen one time. The reference
value, VALUE, and the results of the analysis, RUN1, will be
displayed on the WHOLE BLOOD AUTO-CAL, RESULTS FOR
SPECIMEN (N) screen.
The Auto-Cal program automatically compares the results of
the first run of each whole blood specimen with the
Parameter Reference Values entered for that specimen, to
verify that the difference is within acceptable limits.
• If the first run passes this internal Reference Check,
proceed to step 9.
• If the first run fails the Reference Check for any
parameter, the results are highlighted and the Bulletin
Line displays the following message: RESULT IS
OUTSIDE THE REFERENCE LIMITS. REPEAT THIS
SPECIMEN. Proceed to step 7.
7. The specimen may be repeated at this time by pressing the
[REPEAT SPECIMEN] key followed by the [CONFIRM REPEAT] key.
NOTE: When the repeat function is used, all the results
for that specimen will be automatically deleted.

• If the run passes the Reference Check, proceed to step 9.


• If the repeated run also fails the Reference Check, the
results will be highlighted and no calibration factor will
be calculated for that parameter. Proceed to step 8.
• If all parameters fail the Reference Check, results of that
run are not displayed and the Bulletin Line displays the
following message: ABANDON CAL FOR SPECIMEN 1 -
RESULT NOT INCLUDED IN MEAN. Proceed to step 8.
8. If necessary, repeat the specimen as directed in step 7.
NOTE: Check to be sure the correct specimen was run
before repeating it.
• If the run passes the Reference Check, proceed to step 9.
• If all parameters on the repeated run also fail the
Reference Check, discard that specimen and continue
with the next calibration specimen. If desired, a
replacement specimen may be added after the remaining
specimens have been run.
9. After a run has passed the internal Reference Check, run
each specimen for the number of runs entered in step 2 of
Entering the Reference Values within this chapter.

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Each subsequent run must pass the Reference Check and an


additional internal Precision Check. If a run fails either check,
the result for that parameter is highlighted and no calibration
factor will be calculated for the parameter. Calibration must
be repeated for the highlighted parameter. Calibration factors
will be calculated for the remaining parameters.
10. When all runs of a specimen have been completed, the
Bulletin Line displays the following message: NEW CAL
FACTOR COMPUTED. READY FOR NEXT CAL SPECIMEN.
11. Press the [NEXT SPECIMEN] key to run the next specimen.

Calibration Factor Calculation


As each run of the whole blood samples is completed, a calibration
factor is calculated and updated. This factor is displayed in the
column labeled <SPEC (N) FACTOR>.
The column labeled <MEAN FACTOR (N)> contains the average of the
calibration factors for all of the whole blood samples used in the
calibration. The number in parentheses after mean factor indicates
the number of samples used to compute that mean factor.
The <FACTOR % DIFF> column displays the difference between the
calibration factor currently in the instrument and the mean
factor computed by the Auto-Cal Program.
When all runs of all whole blood samples have been completed,
the following message is displayed on the Bulletin Line:
NEW CAL FACTOR COMPUTED. READY FOR ACCEPTANCE.
1. Press the [PREVIOUS SPECIMEN] key and/or the [NEXT
SPECIMEN] key to review and/or print the results of all whole
blood samples analyzed.
NOTE: These results are only available for review and/or
printing before the [ACCEPT MEANS] key is pressed.
2. Press the [PRINT] key to obtain a printout of the SPEC and
MEAN FACTORS and the FACTOR % DIFF.
3. Enter the factor % difference for each parameter in the Mode to
Mode Auto-Cal Calibration Criteria Worksheet provided at the
end of this procedure. (This worksheet may be duplicated as
needed.) The calibration criteria are depicted in the following
table.
NOTE: Delete the sign of the factor % difference value
before entering it on the worksheet.

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Calibration
Mode To Mode Auto-Cal Calibration (Closed Sampler Only) Chapter 6

To determine which parameters require calibration, continue


with the next section in this chapter, Determining Which
Parameters Need Calibration.

Table 6.4: Mode to Mode Calibration Criteria


Mode to Mode Calibration Criteria
Validation Range Calibration Range Calibration Limit
Cal Not Required Cal Required Do Not Cal
WOC <1.75% >1.75% but <10% >10%
WIC <1.75% >1.75% but <10% >10%
RBC <1.25% >1.25% but <10% >10%
HGB <1.25% >1.25% but <10% >10%
MCV <1.25% >1.25% but <10% >10%
PLT <3.50% >3.50% but <20% >20%

Determining Which Parameters Need Calibration


Validation Range
If the factor % difference is equal to or less than the following
values, then calibration is not required for that parameter because
the value is within the Validation Range.
Results equal to or less than the Validation Range:
WIC/WOC <1.75%
RBC <1.25%
HGB <1.25%
MCV <1.25%
PLT <3.50%
If the results for all parameters are less than the values given above,
press the [QUIT AUTO-CAL] key followed by the [CONFIRM QUIT] key.
If desired, the calibration results may be documented in the Auto-Cal
Calibration Log. The Auto-Cal Calibration Log is available for
comments only when a calibration factor is changed or reentered.
Therefore, to document the calibration in the <COMMENTS> line,
access the log as follows.
1. From the CALIBRATION screen, press the [ENTER FACTOR] key.
2. Retype any existing Cal Factor. Ensure that the cursor is in
the <Closed Sampler Factor> column. Press the Enter key on
the keyboard to save the entry and advance the cursor.

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Chapter 6 Mode To Mode Auto-Cal Calibration (Closed Sampler Only)

3. Press the [RETURN] key.


4. When the CALIBRATION LOG screen is displayed, indicate in the
<COMMENTS> line that instrument calibration was confirmed
and no changes were required. Press the Enter key on the
keyboard to save the entry and advance the cursor.
5. Be certain to retain all necessary documentation in the
instrument logbook.

Calibration Limit
If the factor % difference for a particular parameter is greater than
the following value, the value has exceeded the Calibration Limit
and there may be an instrument problem.
Results greater than the Calibration Limit:
WIC/WOC >10%
RBC >10%
HGB >10%
MCV >10%
PLT >20%
1. Check to see if any component that could affect the calibration
was changed, as this could cause the factor % difference to
exceed the above limits. For example:
Shear Valve RBC/PLT Transducer
WOC Flow Cell RBC/PLT Aperture Plate
WIC Transducer Hemoglobin Flow Cell
WIC Aperture Plate Syringe(s)
• If a component was changed, then calibrate the instrument
as needed according to the directions in this procedure.
• If no components have been changed and the factor %
difference exceeds these limits, do not calibrate. Confirm
that all Pre-Calibration procedures were completed, and
call Abbott Diagnostics Customer Service for assistance
(at 1-877-4ABBOTT in the US).
2. Press the [QUIT AUTO-CAL] key followed by the [CONFIRM
QUIT] key to exit Auto-Cal.
3. Troubleshoot accordingly. Be certain to retain all necessary
documentation in the instrument logbook.

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Mode To Mode Auto-Cal Calibration (Closed Sampler Only) Chapter 6

Calibration Range
If the factor % difference falls within the following Calibration
Range, calibration is required for that parameter. That is, a new
Calibration Factor must be entered. Calibrate the Closed Mode as
directed in this procedure, either for all parameters or for specific
parameters.

Results within the Calibration Range:

WIC/WOC >1.75% but <10%


RBC >1.25% but <10%
HGB >1.25% but <10%
MCV >1.25% but <10%
PLT >3.50% but <20%
If all parameters require calibration, continue with the next
section in this chapter, Calibrating All Parameters. If only
specific parameters require calibration, skip to Calibrating
Individual Parameters within this chapter.

Calibrating All Parameters


If the factor % difference for all parameters falls within the
acceptable Calibration Range limits, perform this procedure.
1. Be certain that all desired printouts have been made.
2. Press the [ACCEPT MEANS] key.
The following message will be displayed on the Bulletin
Line: ALL DATA AND RESULTS WILL BE DELETED.
3. Press the [CONFIRM ACCEPT] key to save the mean factors and
complete the Auto-Cal procedure.
The CALIBRATION LOG screen will be automatically displayed.
The log holds 10 entries. (The screen displays five entries. To
display the other five, press the Page Up key on the keyboard.)
When the log is full, subsequent entries cause the oldest entry
to be deleted and the remaining entries to move up one line so
that the current factors are added to the bottom of the list.
Therefore, the log should be printed periodically for purposes
of documentation.

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The log displays the date, time, operator ID, calibration


factors, and a line for comments.
NOTE: The letters in parentheses after each factor
indicate the method of factor derivation: A = Auto-Cal,
F = Factory, E = Enter Factor (manual factor entry).
4. Type any comments in the <COMMENTS> field. Press the Enter
key on the keyboard to save the entry and advance the cursor.
NOTE: Comments may be added to the Calibration Log
only after a calibration factor is changed or reentered.
5. To obtain a printout of the Calibration Log for
documentation, press the [PRINT LOG] key.

Calibrating Individual Parameters


If only certain individual parameters require calibration, perform
this procedure.
1. Press the [QUIT AUTO-CAL] key followed by the [CONFIRM
QUIT] key to exit Auto-Cal.
2. Press the [RETURN] key twice to display the CALIBRATION screen.
3. Press the [ENTER FACTOR] key to display the ENTER
CALIBRATION FACTOR screen.
4. Move the cursor to the <Closed Sampler Factor> column.
5. Type any mean factors computed by Auto-Cal for those
parameters that require calibration in the appropriate fields.
(Refer to the printout made in step 2 of the Calibration
Factor Calculation subsection of this section, Mode to Mode
Auto-Cal Calibration.) Move the cursor to the desired
position, type the factor, and press the Enter key on the
keyboard to save the factor and advance the cursor.
6. Press the [RETURN] key.
7. When the CALIBRATION LOG screen is displayed, indicate the
parameters that required calibration in the <COMMENTS>
line. Press the Enter key on the keyboard to save the entry
and advance the cursor.
NOTE: Manually entered factors are followed by the
letter E in parentheses to indicate “Enter Factor.”
8. To obtain a printout of the Calibration Log for
documentation, press the [PRINT LOG] key.

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Mode To Mode Auto-Cal Calibration (Closed Sampler Only) Chapter 6

Completing Mode to Mode Calibration


1. Press the [RETURN] key to return to the CALIBRATION screen.
2. Press the [MAIN] key to exit the CALIBRATION screen.
3. Retain all necessary documentation in the instrument logbook.
4. Confirm the calibration of the Closed Mode by running
commercial controls as directed in Post-Calibration
Procedures within this chapter.

Optional Calibration Confirmation


1. If desired, the Closed Mode calibration may also be
confirmed by returning to the AUTO-CALIBRATION screen and
running the specimens again as directed in this procedure.
NOTE: The information entered in step 3 of Entering the
Reference Values is retained, but the results from the
previous runs of the specimens will have been deleted.
2. The Post-Calibration factor % difference must be equal to or
less than the following:
WIC/WOC <1.75%
RBC <1.25%
HGB <1.25%
MCV <1.25%
PLT <3.50%
If the Post-Calibration factor % difference exceeds these limits,
verify that the new calibration factors were entered
correctly. If no errors are detected, call Abbott Diagnostics
Customer Service for assistance (at 1-877-4ABBOTT in the US).

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Chapter 6 Mode To Mode Auto-Cal Calibration (Closed Sampler Only)

CELL-DYN 3700 System


Mode to Mode Auto-Cal Calibration Criteria Worksheet
Instrument: ___________________________________ Date: _______________________________________
Operator: _____________________________________
____________________________________________________________________________________________

Mode to Mode Auto-Cal Calibration Criteria


Factor Validation Range Calibration Range Calibration Limit Cal?
%Diff* (Cal Not Required) (Cal Required) (Do Not Cal**) Y/N
WOC <1.75% >1.75% but <10% >10%
WIC <1.75% >1.75% but <10% >10%
RBC <1.25% >1.25% but <10% >10%
HGB <1.25% >1.25% but <10% >10%
MCV <1.25% >1.25% but <10% >10%
PLT <3.50% >3.50% but <20% >20%
* Delete the sign of the factor % difference value before entering it on the worksheet.
** Do not calibrate. Call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).

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NOTES

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Chapter 6 Calibration

Manual Mode to Mode Calibration (CS or SL)

The calibration procedure has been divided into subsections that


consist of a series of easy-to-follow steps. Always follow the entire
procedure unless specifically directed to skip to another section.

NOTE: Confirm the calibration of the Open Mode before


performing this procedure.

NOTE: Before beginning this procedure, be sure to


complete the Pre-Calibration procedures and read
Overview, Calibration Materials, Whole Blood
Calibration Guidelines and Mode to Mode Calibration
Overview within this chapter.

Preparing for Manual Mode to Mode Calibration


1. From the MAIN MENU screen, press the [CALIBRATION] key.
2. If necessary, press the [CLOSED SAMPLER] key to display the
Closed Mode Calibration Factors.
3. Press the [PRINT] key to obtain a printout of the Closed
Sampler Calibration Factors displayed on the screen.
4. Press the [RETURN] key followed by the [MAIN] key to return
to the MAIN MENU screen.

Determining the Open Mode Mean


1. From the MAIN MENU screen, press the [RUN] key.
2. If necessary, press the [CHANGE SAMPLER] key to select the
Open Mode.
3. Press the [SPECIMEN TYPE] key.
4. Use the arrow keys on the keyboard to move the cursor to
an empty QC file and type “OPEN MEAN” in the <FILE
NAME> field.
5. Press the Enter key on the keyboard to save the name. Use
the Up arrow key on the keyboard to move the cursor back
into the “OPEN MEAN” file.
NOTE: The QC files used for Manual Mode to Mode
Calibration should be configured to display and print
values for WIC and WOC. If necessary, refer to the
directions for customizing display and printout given in
Chapter 5: Operating Instructions, Subsection: Set-Up
Instructions.

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Manual Mode to Mode Calibration (CS or SL) Chapter 6

6. Press the [QC SPECIMEN] key to display the RUN screen.


7. Run each sample one time into the “OPEN MEAN” QC file.
8. Press the [MAIN] key followed by the [QUALITY CONTROL] key
and the [VIEW QC LOG] key.
9. To obtain a printout of the data, press the [PRINT QC LOG]
key.
10. Press the [RETURN] key followed by the [MAIN] key to return
to the MAIN MENU screen.

Determining the Closed Mode Mean


1. From the MAIN MENU screen, press the [RUN] key.
2. If necessary, press the [CHANGE SAMPLER] key to select the
Closed Mode.
3. Press the [SPECIMEN TYPE] key.
4. Use the arrow keys on the keyboard to move the cursor to
an empty QC file and type “CLOSED MEAN” in the <FILE
NAME> field.
5. Press the Enter key on the keyboard to save the name. Use
the Up arrow key on the keyboard to move the cursor back
into the “CLOSED MEAN” file.
NOTE: The QC files used for Manual Mode to Mode
Calibration should be configured to display and print
values for WIC and WOC. If necessary, refer to the
directions for customizing display and printout given in
Chapter 5: Operating Instructions, Subsection: Set-Up
Instructions.

NOTE: If necessary, refer to the directions for running QC


specimens in the CS or Sl mode given in Chapter 5:
Operating Instructions, Subsection: Sample Analysis.

6. Press the [QC SPECIMEN] key to display the RUN screen.


7. Run each sample one time into the “CLOSED MEAN” QC
file.
8. Press the [MAIN] key followed by the [QUALITY CONTROL] key
and the [VIEW QC LOG] key.
9. To obtain a printout of the data, press the [PRINT QC LOG]
key.
10. Press the [RETURN] key followed by the [MAIN] key to return
to the MAIN MENU screen.

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Calibration
Chapter 6 Manual Mode to Mode Calibration (CS or SL)

Percent Difference Calculation


1. Use the mean value for each parameter from the “OPEN
MEAN” and “CLOSED MEAN” file printouts for these
calculations.
2. Enter the information from step 1 on the Manual Mode to
Mode Calibration Worksheet and calculate the Mode to
Mode Calibration Bias for each parameter as follows:

Closed Mode Mean – Open Mode Mean


x 100 = % Difference
Open Mode Mean

3. On the worksheet, enter the % difference for each parameter


in the Mode to Mode Calibration Criteria Chart (depicted in
the following table).
NOTE: Delete the sign of the % difference before entering
it on the chart.

4. To determine which parameters require calibration,


continue with the next section in this chapter, Determining
Which Parameters Need Calibration.

Table 6.5: Mode to Mode Calibration Criteria


Mode to Mode Calibration Criteria
Validation Range Calibration Range Calibration Limit
Cal Not Required Cal Required Do Not Cal
WOC <1.75% >1.75% but <10% >10%
WIC <1.75% >1.75% but <10% >10%
RBC <1.25% >1.25% but <10% >10%
HGB <1.25% >1.25% but <10% >10%
MCV <1.25% >1.25% but <10% >10%
PLT <3.50% >3.50% but <20% >20%

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Calibration
Manual Mode to Mode Calibration (CS or SL) Chapter 6

Determining Which Parameters Need Calibration


Validation Range
If the % difference is equal to or less than the following values,
then calibration is not required for that parameter because the
value is within the Validation Range.
Results equal to or less than the Validation Range:
WIC/WOC <1.75%
RBC <1.25%
HGB <1.25%
MCV <1.25%
PLT <3.50%
If desired, the Manual Mode to Mode Calibration results may be
documented in the Auto-Cal Calibration Log. The Auto-Cal
Calibration Log is available for comments only when a calibration
factor is changed or reentered. Therefore, to document the
calibration in the <COMMENTS> line, access the log as follows.
1. From the CALIBRATION screen press the [ENTER FACTOR] key.
2. Retype any existing Cal Factor. Ensure that the cursor is in
the <Closed Sampler Factor> column. Press the Enter key on
the keyboard to save the entry and advance the cursor.
3. Press the [RETURN] key.
4. When the CALIBRATION LOG screen is displayed, indicate in the
<COMMENTS> line that instrument calibration was confirmed
and no changes were required. Press the Enter key on the
keyboard to save the entry and advance the cursor.
5. Be certain to retain all necessary documentation in the
instrument logbook.

Calibration Limit
If the factor % difference for a particular parameter is greater than
the following values, the value has exceeded the Calibration Limit
and there may be a computation error or instrument problem.

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Calibration
Chapter 6 Manual Mode to Mode Calibration (CS or SL)

Results greater than the Calibration Limit:


WIC/WOC >10%
RBC >10%
HGB >10%
MCV >10%
PLT >20%
1. Recheck the numbers entered on the worksheets and then
recheck all calculations.
2. Check to see if any component was changed which could
affect the calibration, as this could cause the factor %
difference to exceed the above limits. For example:
Shear Valve RBC/PLT Transducer
WOC Flow Cell RBC/PLT Aperture Plate
WIC Transducer Hemoglobin Flow Cell
WIC Aperture Plate Syringe(s)
• If a component was changed, then calibrate the
instrument as needed according to the directions in the
following sections.
• If no components have been changed, the calculations
are correct, and the % difference exceeds these limits, do
not calibrate. Confirm that all Pre-Calibration procedures
were completed and then call Abbott Diagnostics
Customer Service for assistance (at 1-877-4ABBOTT in
the US).

Calibration Range
If the factor % difference falls within the following Calibration
Range, calibration is required for that parameter. Calibrate the
instrument as directed in the following sections, either for all
parameters or for specific parameters.
Results within the Calibration Range:
WIC/WOC >1.75% but <10%
RBC >1.25% but <10%
HGB >1.25% but <10%
MCV >1.25% but <10%
PLT >3.50% but <20%

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Calibration
Manual Mode to Mode Calibration (CS or SL) Chapter 6

Calibration Factor Calculation


Use the appropriate worksheet to calculate the New Closed Mode
Calibration Factor for the parameters that require calibration. (Use
the Current Closed Mode Cal Factor that was printed in Preparing
for Mode to Mode Calibration at the start of this procedure.)
Open Mode Mean
x Current Closed Mode Cal Factor = New Closed Factor
Closed Mode Mean

• If the New Closed Mode Calibration Factor falls within the


acceptable range given on the worksheet, calibrate the
Closed Mode as directed in the next section of this chapter,
Calibrating the Closed Mode.
• If the New Closed Mode Calibration Factor for a given
parameter falls outside the acceptable range, there may be a
computation error. Do not calibrate that parameter. Recheck
all calculations and then call Abbott Diagnostics Customer
Service for assistance (at 1-877-4ABBOTT in the US).

Calibrating the Closed Mode


1. From the MAIN MENU screen, press the [CALIBRATION] key.
2. Press the [ENTER FACTOR] key to display the ENTER
CALIBRATION FACTOR screen.
3. Type the New Closed Mode Calibration Factors for the
parameters that require calibration in the appropriate fields
in the <CLOSED SAMPLER> column. Move the cursor to the
desired position, type the factor, and press the Enter key on
the keyboard to save the factor and advance the cursor.
4. After the New Closed Mode Calibration Factors have been
entered, press the [RETURN] key.
5. The CALIBRATION LOG screen will be automatically displayed.
The log holds 10 entries. (The screen displays five entries.
To display the other five, press the Page Up key on the
keyboard.) When the log is full, subsequent entries cause
the oldest entry to be deleted and the remaining entries to
move up one line, so that the current factors are added to
the bottom of the list. Therefore, the log should be printed
periodically for purposes of documentation.
The log displays the date, time, operator ID, calibration
factors, and a line for comments.
NOTE: The letters in parentheses after each factor
indicate the method of factor derivation: A = Auto-Cal,
F = Factory, E = Enter Factor (manual factor entry).

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Calibration
Chapter 6 Manual Mode to Mode Calibration (CS or SL)

6. Type any comments in the <COMMENTS> field. Press the Enter


key on the keyboard to save the entry and advance the cursor.
NOTE: Comments may be added to the Calibration Log
only after a calibration factor is changed or reentered.

7. To obtain a printout of the Calibration Log for


documentation, press the [PRINT LOG] key.

Completing Mode to Mode Calibration


1. Press the [RETURN] key to display the CALIBRATION screen.
2. Press the [MAIN] key to exit the CALIBRATION screen.
3. Retain all necessary documentation in the instrument logbook.
4. Confirm the calibration of the Closed Mode by running
commercial controls as directed in Post-Calibration
Procedures within this chapter.

Optional Calibration Confirmation


If desired, the Closed Mode calibration may also be confirmed by
repeating the whole blood specimens as directed in the following two
sections, Delete the Existing Data and Calibration Confirmation.

Delete the Existing Data


1. From the MAIN MENU screen, press the [QUALITY CONTROL] key.
2. Use the arrow keys on the keyboard to move the cursor to
the “CLOSED MEAN” file and press the [VIEW QC LOG] key.
NOTE: Be certain all desired printouts have been made
before the data are deleted.
3. Delete the information in the file: press the [PURGE QC LOG]
key followed by the [CONFIRM PURGE] key.

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Calibration
Manual Mode to Mode Calibration (CS or SL) Chapter 6

Calibration Confirmation
1. Run the same whole blood specimens into the “CLOSED
MEAN” file again by repeating the steps in Manual Mode to
Mode Calibration, Determining the Closed Mode Mean
within this chapter.
2. The Post-Calibration difference must be equal to or less than
the following:
WIC/WOC <1.75%
RBC <1.25%
HGB <1.25%
MCV <1.25%
PLT <3.50%
Calculate the Post-Calibration difference using the Mode to Mode
Post-Calibration Difference chart on the Manual Mode to Mode
Worksheet.
If the Post-Calibration difference exceeds these limits, verify that
all calculations were correct and that the new factors were
entered correctly. If no errors are detected, call Abbott
Diagnostics Customer Service for assistance (at 1-877-4ABBOTT
in the US).

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Calibration
Chapter 6 Manual Mode to Mode Calibration (CS or SL)

CELL-DYN 3700 System


Manual Mode to Mode Calibration Worksheet
Instrument: ___________________________________ Date: _______________________________________
Operator: _____________________________________
____________________________________________________________________________________________
Calculate All Factors To Three Decimal Places

Mode to Mode Calibration Difference

Closed Mode Mean - Open Mode Mean


x 100 = % Diff
Open Mode Mean

Closed Open Mode Open Mode


Mode Mean – Mean / Mean x 100 = % Diff
WOC – / x 100 =
WIC – / x 100 =
RBC – / x 100 =
HGB – / x 100 =
MCV – / x 100 =
PLT – / x 100 =

Mode to Mode Calibration Criteria


Validation Range Calibration Range Calibration Limit Cal?
%Diff* (Cal Not Required) (Cal Required) (Do Not Cal**) Y/N
WOC <1.75% >1.75% but <10% >10%
WIC <1.75% >1.75% but <10% >10%
RBC <1.25% >1.25% but <10% >10%
HGB <1.25% >1.25% but <10% >10%
MCV <1.25% >1.25% but <10% >10%
PLT <3.50% >3.50% but <20% >20%
* Delete the sign of the % difference value before entering it on the worksheet.
** Do not calibrate. Call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).

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9140320E — September 2004
Calibration
Manual Mode to Mode Calibration (CS or SL) Chapter 6

New Closed Mode Calibration Factors

Open Mode Mean


x Current Closed Mode Cal Factor* = New Closed Mode Cal Factor
Closed Mode Mean

Current New Closed


Open Mode Closed Mode Closed Mode Mode
Mean / Mean x Cal Factor* = Cal Factor Range**
WOC / x = 0.700–1.300
WIC / x = 0.700–1.300
RBC / x = 0.800–1.200
HGB / x = 0.700–1.300
MCV / x = 0.700–1.300
PLT / x = 0.700–1.300
* Current factor as printed by the operator in the Preparing for Manual Mode to Mode Calibration section within this
procedure (Manual Mode to Mode Calibration).
** If factor exceeds limits, do not calibrate. Check all calculations and call Abbott Diagnostics Customer Service for
assistance (at 1-877-4ABBOTT in the US).

Mode to Mode Post-Calibration Difference

Closed Mode Mean - Open Mode Mean


x 100 = % Difference
Open Mode Mean

Closed Mode Open Mode Open Mode


Mean* – Mean / Mean x 100 = % Diff Range**
WOC – / x 100 = <1.75%
WIC – / x 100 = <1.75%
RBC – / x 100 = <1.25%
HGB – / x 100 = <1.25%
MCV – / x 100 = <1.25%
PLT – / x 100 = <3.50%
* Mean after calibration.
** If % Diff exceeds limits, call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).

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Calibration
Chapter 6 Post-Calibration Procedures

Post-Calibration Procedures

If calibration was changed, complete the procedures in this section.

Quality Control
Confirm calibration changes by running all levels of controls into
the appropriate QC files. If any parameters fall outside the limits,
proceed as follows:
1. Obtain new vials of the controls.
2. Warm and mix them properly and again run them into the
appropriate QC files.
If parameters still exceed the limits, proceed as follows:
1. Collect all the calibration documentation including the
Pre-Calibration worksheets. (Be certain you have recorded
lot numbers where indicated.)
2. Call Abbott Diagnostics Customer Service for assistance
(at 1-877-4ABBOTT in the US).
NOTE: Inform the Customer Support Specialist if a
reagent and/or lot number of reagent was changed just
prior to the calibration procedure.

3. Include documentation as to the resolution of the problem


in the instrument logbook.

Calibration Backup
The current calibration factors should be saved on the
CELL-DYN 3700 Set-Up Disk #1 whenever calibration is changed.
Data should also be saved whenever any setup information is
changed and after any service work is performed. The backup
procedure copies the following setup information from the Data
Station to the Set-Up Disk:
• Calibration Factors
• QC Limits
• Patient Limits
• Analyzer Module Set Points (for example, gains, dil factors
the [internal calibration factors] key, thresholds, pressure/
vacuum settings)
• RBC Editing Ratio
• Units Selection

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9140320E — September 2004
Calibration
Post-Calibration Procedures Chapter 6

To back up the calibration factors, proceed as follows:


1. Perform the Daily Shutdown Procedure described in
Chapter 5: Operating Instructions, Subsection: Routine
Operation.
2. Turn the Data Station power switch OFF.
3. Obtain the Set-Up Disk #1 from the diskette box located
behind the Upper Front Cover of the Analyzer.
4. Insert the Set-Up Disk #1 in the Data Station disk drive.
5. Turn the Data Station power switch ON.
The Data Station screen displays the following:
THIS IS THE CD3700 SETUP DISK
TO USE, TYPE EITHER SAVE the [ENTER] OR
RESTORE [ENTER] AND FOLLOW THE INSTRUCTIONS.
NOTE: The restore option copies setup information from
the Set-Up Disk to the Data Station hard disk. This option
is used when a hardware or software failure occurs and
should only be used at the direction of Technical Service
or Abbott Diagnostics Customer Service.

6. Type SAVE. Press the Enter key on the keyboard.


The screen will display the following:

THIS UTILITY WILL SAVE YOUR DATA FILES ONTO


YOUR SETUP DISK TO KEEP THEM BACKED UP
SAFELY.

THE FOLLOWING FILES WILL BE SAVED:


(1) NONVOL
(2) QC LOG
(3) CALIBRATION LOG
(4) MAINTENANCE LOG
(5) ANIMAL TYPE CONFIGURATION
(CD3700 ONLY)
PROCEED (Y/N)?

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Calibration
Chapter 6 Post-Calibration Procedures

7. Type Y. Press the Enter key on the keyboard.


The setup information is copied from the Data Station hard
disk onto the setup disk. Previous setup information that
was stored on the disk is overwritten.
When the copy process is complete, the “a:>” prompt will be
displayed on the screen.
8. Remove the Set-Up Disk #1 from the disk drive and return it
to the diskette box.
9. Turn the Data Station power switch OFF.
10. Wait five seconds and then turn the Data Station power
switch ON.

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Calibration
Post-Calibration Procedures Chapter 6

NOTES

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Calibration
Chapter 6 References

References

1. International Committee for Standardization in


Haematology (ICSH). Protocol for Evaluation of Automated
Blood Cell Counters. Clinical and Laboratory Hematology
1984; 6:69-84.
2. Clinical and Laboratory Standards Institute/NCCLS.
Procedure for Determining Packed Cell Volume by the
Microhematocrit Method; Approved Standard – Third Edition.
CLSI/NCCLS document H7-A3 (ISBN 1-56238-413-9) 940
West Valley Road, Suite 1400, Wayne, PA 19087-1898, 2000.

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9140320F — April 2007
Calibration
References Chapter 6

NOTES

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Chapter 7 Quality Control
Quality Control

Overview

The first section of this chapter describes the functions of the keys
in the QC MENU. Interpretation of the QC data is then discussed in
the Quality Control Guide.

The CELL-DYN® 3700 System offers three Quality Control options


to monitor and validate instrument performance:

QC Files Statistical and graphical analyses of the


data in each of 20 QC files calculate the
mean, standard deviation, and
coefficient of variation.
Westgard Rules A multi-rule system is applied to the data
in each of the QC files.
X-B Analysis Bull’s Moving Average Program is
applied to the RBC Indices and a similar
moving average calculation is applied to
some WBC Differential optical
parameters.
The options may be used independently or in combination at the
operator’s discretion. The QC files are discussed in Quality
Control Menu, View QC Log Soft Key within this chapter. X-B
Analysis and Westgard Rules are discussed in the Quality Control
Guide within this chapter. The Quality Control Guide also
includes information about Running Controls.

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9140320C — November 2000
Quality Control
Overview Chapter 7

Quality Control Menu Flowchart

QC MENU
Ready

X-B X-B VIEW QC SET UP CUSTOMIZE CUSTOMIZE MAIN


SET UP FILE QC LOG LIMITS QC FILE DISPLAY PRINTOUT

TURN ON TURN ON PRINT RETURN


X-B RBC X-B WBC SELECT CANCEL STANDARD RETURN
TURN OFF TURN OFF PARAMETER SELECTION SELECTION
X-B RBC X-B WBC PLACE
PARAMETER

X-B RBC X-B WBC PRINT RETURN SELECT CANCEL STANDARD TOGGLE RETURN
GRAPHS GRAPHS PARAMETER SELECTION GROUPS ONE/ALL
X-B RBC X-B WBC PLACE CUSTOM
DATA DATA PARAMETER PLACEMENT

WBC RBC PLT DIFF CUSTOMIZE RETURN


GROUP GROUP GROUP GROUP PRINTOUT

LOT TOGGLE PRINT RETURN


NUMBER ON/OFF
REPLICATE
ID

RANGE UPDATE LOAD PRINT RETURN


ENTRY FROM FILE FROM DISK
MEANS/
LIMITS

LOAD LOAD LOAD RETURN


LOW NORMAL HIGH
PURGE LEVEY- REJECT DELETE MOVE WRITE QC PRINT RETURN
QC LOG JENNINGS SPECIMEN SPECIMEN SPECIMEN TO DISK QC LOG
ACCEPT
SPECIMEN
CONFIRM CANCEL
CONFIRM CANCEL UPDATE UPDATE
PURGE PURGE CONFIRM CANCEL
DELETION DELETION

MOVE TO CANCEL
FILE MOVE

GROUP GROUP GROUP GROUP PRINT RETURN WRITE WRITE WRITE RETURN
1 2 3 4 LOW NORMAL HIGH

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9140320C — November 2000
Chapter 7 Quality Control

Quality Control Menu

The [QUALITY CONTROL] key on the MAIN MENU screen is used to


display the QC MENU screen. The options available from this screen
can be used to set up the QC files. QC files can also be set up
using the QC SET UP MENU described in Chapter 5: Operating
Instructions, Subsection: Set Up Instructions.

QC MENU Nov 20 1998 16:01


Ready Operator ID rcs
Sequence # 0711

File Name # Specimens File Name # Specimens

1. Low 11 11. Patient 30


2. Normal 13 12. FILE 12 0
3. High 0 13. FILE 13 0
4. FILE 4 0 14. FILE 14 0
5. FILE 5 0 15. FILE 15 0
6. FILE 6 0 16. FILE 16 0
7. FILE 7 0 17. FILE 17 0
8. FILE 8 0 18. FILE 18 0
9. FILE 9 0 19. FILE 19 0
10. FILE 10 0 20. FILE 20 0

Select a QC file with the arrow keys or enter a new file name.

X-B X-B VIEW QC SET UP CUSTOMIZE CUSTOMIZE MAIN


SET UP FILE QC LOG LIMITS QC FILE DISPLAY PRINTOUT

Figure 7.1: QC Menu Screen

QUALITY The following soft key labels are displayed on the QC MENU screen:
CONTROL
X-B SET UP*
X-B FILE
VIEW QC LOG
QC LIMITS*
SET-UP QC FILE*
CUSTOMIZE DISPLAY*
CUSTOMIZE PRINTOUT*
MAIN
*These keys are discussed in Chapter 5: Operating Instructions,
Subsection: Set Up Instructions, QC Set Up Menu Soft Key.

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9140320C — November 2000
Quality Control
Quality Control Menu Chapter 7

X-B File Soft Key


X-B The following soft key labels are displayed when the [X-B FILE] key
FILE is pressed:
X-B RBC DATA or
X-B RBC GRAPHS (The key label alternates between these
two selections.)
X-B WBC DATA or
X-B WBC GRAPHS (The key label alternates between these
two selections.)
PRINT
RETURN
X-B RBC Data Soft Key

X-B FILE DISPLAY


Standby Dec 12 1998 11:47
PAGE UP/DN FOR MORE DATA Operator ID abc
Sequence # 1491
X-B RBC DATA

BATCH MCV MCH MCHC DATE TIME

1 90.10 30.19 33.52 12/10/98 14:42


2 90.51 30.54 33.56 12/10/98 17:21
3 90.50 30.43 33.52 12/10/98 21:05
4 89.47 30.11 33.50 12/11/98 04:07
5 89.72 30.26 33.56 12/11/98 06:02
6 89.71 30.24 33.56 12/11/98 07:26
7 89.57 30.11 33.54 12/11/98 08:24
8 89.93 30.11 33.45 12/11/98 09:29
9 91.61 30.63 33.45 12/11/98 11:05
10 91.83 30.80 33.52 12/11/98 11:54

Upper 92.39 31.21 34.71


Lower 87.01 29.39 32.69

X-B RBC X-B WBC PRINT RETURN


GRAPHS GRAPHS

Figure 7.2: The X-B RBC Data Screen

X-B RBC The [X-B RBC DATA] key is used to display the X-B data for RBC indices
DATA on the X-B FILE DISPLAY screen. (See the preceding figure.) This screen
X-B RBC displays the results for X-B batches 1–10 and the lower and upper
GRAPHS
limits. The date and time that each batch was completed are also
displayed. The Page Down key on the keyboard is used to display
batches 11–20. When batches 11–20 are displayed, the Page Up key on
the keyboard is used to display batches 1–10.
NOTE: The X-B RBC data can also be viewed as graphs by
pressing the [X-B RBC GRAPHS] key.

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Quality Control
Chapter 7 Quality Control Menu

X-B RBC Graphs Soft Key


X-B RBC The [X-B RBC GRAPHS] key is used to display the X-B graphs for
GRAPHS RBC indices on the X-B FILE DISPLAY screen. (See the following
X-B RBC
DATA figure.) This screen displays the results for X-B batches 1–20 and
the lower and upper limits.
NOTE: The X-B RBC data can also be viewed as data in
tables by pressing the [X-B RBC DATA] key.

X-B FILE DISPLAY Dec 12 1998 11:47


Standby Operator ID abc
Sequence # 1491
X-B RBC GRAPHS

MCV MCH MCHC

92.39 31.21 34.71


89.70 30.30 33.70
87.01 29.39 32.69

X-B RBC X-B WBC PRINT RETURN


DATA GRAPHS

Figure 7.3: The X-B RBC Graphs Screen

X-B WBC Data Soft Key


X-B WBC The [X-B WBC DATA] key is used to display the X-B data for WBC
DATA differential optical parameters on the X-B FILE DISPLAY screen. (See
X-B WBC
GRAPHS
the following figure.) This screen displays the results for X-B
batches 1–10 and the lower and upper limits. The date and time
that each batch was completed are also displayed. The Page Down
key on the keyboard is used to display batches 11–20. When
batches 11–20 are displayed, the Page Up key on the keyboard is
used to display batches 1–10.
NOTE: The X-B WBC data can also be viewed as graphs by
pressing the [X-B WBC GRAPHS] key.

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9140320C — November 2000
Quality Control
Quality Control Menu Chapter 7

X-B FILE DISPLAY


Standby Dec 12 1998 11:47
PAGE UP/DN FOR MORE DATA Operator ID abc
Sequence # 1491
X-B WBC DATA

BATCH L0D L10D N0D N10D N90D N90DEP NEU-EO DATE TIME

1 62 64 151 142 111 17 21.2 12/10/98 14:42


2 62 63 151 142 114 18 21.4 12/10/98 17:21
3 62 64 152 144 117 18 21.2 12/10/98 21:05
4 62 62 152 135 117 18 21.1 12/11/98 04:07
5 62 68 151 130 116 18 20.7 12/11/98 06:02
6 62 63 150 136 115 18 20.7 12/11/98 07:26
7 62 63 152 146 115 17 20.4 12/11/98 08:24
8 62 63 154 147 116 17 20.4 12/11/98 09:29
9 64 63 159 149 120 18 20.4 12/11/98 11:05
10 63 62 155 147 119 18 20.4 12/11/98 11:54

Upper 74 73 176 168 137 20 27.3


Lower 50 49 118 112 91 14 14.7

X-B RBC X-B WBC PRINT RETURN


GRAPHS GRAPHS

Figure 7.4: The X-B WBC Data Screen

X-B WBC Graphs Soft Key


X-B WBC The [X-B WBC GRAPHS] key is used to display the X-B graphs for
GRAPHS WBC differential optical parameters on the X-B FILE DISPLAY
X-B WBC
DATA
screen. (See the following figure.) This screen displays the results
for X-B batches 1–20 and the lower and upper limits.
NOTE: The X-B WBC data can also be viewed as data in
tables by pressing the [X-B WBC DATA] key.

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Quality Control
Chapter 7 Quality Control Menu

X-B FILE DISPLAY Dec 12 1998 11:47


Standby Operator ID abc
Sequence # 1491
X-B WBC GRAPHS
L0D L10D N0D
74 73 176
62 61 147
50 49 118

N10D N90D N90DEP


168 137 20
140 114 17
112 91 14

NEU-EO
27.3
21.0
14.7

X-B RBC X-B WBC PRINT RETURN


GRAPHS DATA

Figure 7.5: The X-B WBC Graphs Screen

Print Soft Key


PRINT The [PRINT] key is used to print the X-B data and graphs. When this
key is pressed, the data and graphs for all 20 batches are
automatically printed if the data or graphs are displayed.

Return Soft Key


RETURN The [RETURN] key is used to return to the QC MENU screen.

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9140320C — November 2000
Quality Control
Quality Control Menu Chapter 7

View QC Log Soft Key

1 Lot Number: N0041


2 VIEW QC LOG 3 Nov 26 1998 10:46
Exp. Date: 12/06/98 Ready Operator ID 732
Norm 41 OPEN: 29/120 USE < OR > FOR MORE DATA Sequence # 6632
Page 4 of 4

4 Upper Limits: 8.60 8.60 8.60 4.51 13.6 91.7 270.


Lower Limits: 7.40 7.40 7.40 4.15 12.8 85.7 220.
Target Mean: 8.00 8.00 8.00 4.33 13.2 88.7 245.
Seq WBC WOC WIC RBC HGB MCV PLT 5 Date Time Op
6627 8.12 8.12 7.96 4.32 13.3 89.5 225. O 11/20/98 10:10 732
6628 7.80 7.80 7.68 4.32 13.3 98.7 231. O 11/20/98 10:12 732

WBC WOC WIC RBC HGB MCV PLT


6 N: 27 27 27 27 27 27 27
File Mean: 8.03 8.03 7.76 4.31 13.3 89.7 235.
Std Dev: .110 .110 .150 .055 .101 .465 7.27
CV (./.): 1.4 1.4 1.9 1.3 0.8 0.5 3.1

PURGE LEVEY- REJECT DELETE MOVE WRITE QC PRINT RETURN


QC LOG JENNINGS SPECIMEN SPECIMEN SPECIMEN TO DISK QC LOG

Figure 7.6: The View QC Log Screen

VIEW The [VIEW QC LOG] key is used to display the QC Log indicated by
QC LOG the position of the cursor. Each QC Log display shows the
following information (see the preceding figure):
1. Upper Left Corner
Lot Number and Expiration Date if the file was configured
for this type of control. If the file was configured for a
Replicate ID, it is displayed here.
File name, the number of runs currently in the file, and the
file capacity (e.g.: 29/120 indicates that the file contains 29
runs out of a possible 120).
The page number of the display and the total number of
pages in the file.
2. Status Box
Screen name, system status, and USE < OR > FOR MORE
DATA. This message indicates that the Left and Right arrow
keys on the keyboard should be used to display the other
groups of data.

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3. Upper Right Corner


The current date, time, and operator ID are displayed along
with the last sequence number that was used.
4. The remainder of the screen displays the file information and
the data. The Upper and Lower Limits and Target Mean
entered are displayed immediately above the parameter
names. The sequence number for each result is displayed to
the left of the data, and the results are displayed below the
parameter. The date, time, and operator ID when the sample
was run are displayed to the right of the data.
5. The following QC Log codes are displayed in the column
immediately preceding the date. These codes are the same as
those used in the Data Log:
O — Sample was run in the Open Mode
C — Sample was run in the Closed Mode
N — Incomplete aspiration in the Open Mode
I — Incomplete aspiration in the Closed Mode
K — Metering fault (Clog or Flow Error)
M — Mixing error on the Sample Loader
V — Sample was run in the Veterinary Mode
B — Blood in line

6. The statistics are displayed below the data as follows:


N: The number of runs used in the calculation
FILE MEAN: The mean value for the number of runs used
in the calculation
STD DEV: The standard deviation for the number of
runs used in the calculation
CV (%): The Coefficient of Variation in percent for
the number of runs used in the calculation
NOTE: Quality Control results that fall at the boundaries of
the selected limit set may be colored differently in the QC
and Data Logs. This is possible due to differences in
numerical rounding between the two logs. The result that
will be displayed, printed and reported is the same in both
logs and is accurate. Use the color in the data log view to
determine whether the results are outside the entered limits.

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The following soft key labels are displayed on the VIEW QC LOG
screen:
PURGE QC LOG
LEVEY-JENNINGS
REJECT SPECIMEN or
ACCEPT SPECIMEN (This key label alternates between
these two selections.)
DELETE SPECIMEN
MOVE SPECIMEN
WRITE QC TO DISK
PRINT QC LOG
RETURN

Purge QC Log Soft Key


PURGE The [PURGE QC LOG] key is used to delete the contents of the QC
QC LOG Log. When the [PURGE QC LOG] key is pressed, the following soft
key labels are displayed:

CONFIRM PURGE
CANCEL PURGE
These keys are used to confirm or cancel the [PURGE QC LOG]
command.

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Levey-Jennings Soft Key

QC file: NORM 41 OPEN LEVEY-JENNINGS MENU Nov 26 1998 10:46


Seq num: 5597 to 6628 Ready Operator ID 732
Sequence # 6632
WBC: WOC: WIC:

8.60 8.60 8.60


8.00 8.00 8.00
7.40 7.40 7.40

RBC: HGB: MCV:

4.51 13.6 91.7


4.33 13.2 88.7
4.15 12.8 85.7

PLT:

270.
245.
220.

GROUP GROUP GROUP PRINT RETURN


2 3 4

Figure 7.7: The Levey-Jennings Menu Screen

LEVEY- The [LEVEY-JENNINGS] key accesses the LEVEY-JENNINGS MENU


JENNINGS screen, which is used to display the Levey-Jennings graphs of the
data in the QC file. (See the preceding figure.) The following soft
key labels are displayed on the LEVEY-JENNINGS MENU screen:

GROUP 1*
GROUP 2
GROUP 3
GROUP 4
PRINT
RETURN
* The soft key for the group currently shown on the screen is not
displayed.
GROUP Each of these keys is used to select the graphs for a group of data
1– 4 that corresponds to the groups selected in the Customize QC
Display option. Subsequent groups can be selected by pressing the
appropriate soft keys.

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The [PRINT] key is used to print the Levey-Jennings graphs. When


PRINT
the [PRINT] key is pressed, all of the graphs are automatically
printed.

RETURN The [RETURN] key is used to return to the VIEW QC LOG screen.

Reject Specimen/Accept Specimen Soft Key

Lot Number: N0041 V IEW QC LOG Nov 26 1998 10:48


Exp. Date: 12/06/98 Ready Operator ID 732
Norm 41 OPEN: 29/120 USE < OR > FOR MORE DATA Sequence # 6632
Page 4 of 4

Upper Limits: 8.60 8.60 8.60 4.51 13.6 91.7 270.


Lower Limits: 7.40 7.40 7.40 4.15 12.8 85.7 220.
Target Mean: 8.00 8.00 8.00 4.33 13.2 88.7 245.
Seq WBC WOC WIC RBC HGB MCV PLT Date Time Op
6627 R 8.12 8.12 7.96 4.32 13.3 89.5 225. O 11/20/98 10:10 732
6628 7.80 7.80 7.68 4.32 13.3 89.7 231. O 11/20/98 10:12 732

WBC WOC WIC RBC HGB MCV PLT


N: 26 26 26 26 26 26 26
File Mean: 8.02 8.02 7.75 4.31 13.3 89.7 236.
Std Dev: .111 .111 .147 .056 .103 .471 7.14
CV (./.): 1.4 1.4 1.9 1.3 0.8 0.5 3.0

PURGE LEVEY- ACCEPT DELETE MOVE WRITE QC PRINT RETURN


QC LOG JENNINGS SPECIMEN SPECIMEN SPECIMEN TO DISK QC LOG

Figure 7.8: QC Log Screen With Rejected Results

REJECT The [REJECT SPECIMEN] key is used to exclude the results for the
SPECIMEN specimen indicated by the cursor position. When the key is
ACCEPT
SPECIMEN
pressed, the key label changes to [ACCEPT SPECIMEN], an “R” is
displayed in the column immediately left of the results, and the
statistics are recomputed excluding those results. (See the
preceding figure.) The data are still displayed and stored in the file
but are excluded from the statistical calculation.

When the [ACCEPT SPECIMEN] key is pressed, the “R” is deleted and
the statistics are recomputed including those results.

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Delete Specimen Soft Key


DELETE The [DELETE SPECIMEN] key is used to delete the results for the
SPECIMEN specimen indicated by the cursor position. When the [DELETE
SPECIMEN] key is pressed, the following key labels are displayed:

CONFIRM DELETION
CANCEL DELETION
These keys are used to confirm or cancel the delete command.
When the [CONFIRM DELETION] key is pressed, the results are
deleted from the file (the data are not displayed or stored in the
file) and the statistics are recomputed excluding those results.

Move Specimen Soft Key


MOVE The [MOVE SPECIMEN] key is used to move the QC result indicated
SPECIMEN by the cursor position to another QC file. When the [MOVE
SPECIMEN] key is pressed, the QC MENU screen is displayed,
allowing the desired file to be selected. When the [MOVE TO FILE]
key is pressed from the QC MENU screen, the result is moved to the
indicated file.

Move Specimen Procedure


1. From the QC MENU screen, use the arrow keys on the
keyboard to move the cursor to the file containing the
specimen to be moved.
2. Press the [VIEW QC LOG] key.
3. Use the arrow keys on the keyboard to position the cursor at
the result that is to be moved.
4. Press [MOVE SPECIMEN] to again display the QC MENU screen.
5. Use the arrow keys on the keyboard to move the cursor to the
file in which the results are to be placed.
6. Press [MOVE TO FILE] to move the results to the designated
file.
NOTE: The result is moved to the end of the list of data
that are currently in the file.

7. The VIEW QC LOG screen of the original file is displayed


showing that the results have been moved.

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Write QC to Disk Soft Key


WRITE QC The [WRITE QC TO DISK] key enables the download of data from a
TO DISK QC file to a floppy disk.

Procedure: Write QC to Disk


1. From the MAIN MENU screen, press [QUALITY CONTROL].
2. Place the cursor on the desired file and press [VIEW QC LOG].
3. Place the disk to be returned to the CELL-DYN
Interlaboratory QC Program in to the Data Station disk drive,
4. Press [WRITE LOW] to transfer data into the low control disk
file [WRITE NORMAL] to transfer data into the normal control
disk file [WRITE HIGH] to transfer data into the high control
disk file.
5. Press [RETURN] and select another file.
6. Repeat steps 3-5 until all QC data has been loaded onto the
disk.
7. Remove the disk from the drive and send to the appropriate
address for the Interlaboratory comparison program.

Print QC Log Soft Key


PRINT The [PRINT QC LOG] key is used to print the entire QC Log.
QC LOG

Return Soft Key


RETURN The [RETURN] key is used to return to the QC MENU screen.

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Chapter 7 Quality Control

Quality Control Guide

The first section of this Guide gives information about running


controls and guidelines for basic assay verification. The section on
Westgard Rules defines the rules used on the CELL-DYN 3700
System and gives guidance for their application in the hematology
laboratory. X-B analysis is discussed in detail in the last section.
All QC data should be reviewed according to your laboratory’s
protocol. Refer to the section on Westgard Rules for suggestions
on how to use them in a review protocol. Refer to the section on
X-B Analysis for suggestions and guidelines for interpreting X-B
results for RBC and WBC data.

Running Controls
Control Material
Abbott recommends using the CELL-DYN control materials for
performing quality control checks on the CELL-DYN 3700 System.
These controls should be run:
• After daily start up procedures are completed.
• After a reagent lot number change.
• After calibration (confirmatory step).
• After a service call or component replacement.
• In accordance with the laboratory’s quality control protocol.
• According to regulatory requirements.
The CELL-DYN controls can be run in any mode of operation:
Open Mode, CS Mode, or SL Mode.
NOTE: Controls for the Sample Loader and Closed
Sampler Modes are packaged in tubes with pierceable caps.

Mixing and Handling


Always mix and handle commercial control materials according to
the directions given in the package insert. As the directions may
vary from manufacturer to manufacturer, pay particular attention
to the following:
• Check the condition of the control material when it is
received in the laboratory. Be sure the tubes are at the proper
temperature and are not leaking. Check for hemolysis.

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• Store the controls at recommended temperatures. Storage in


a central location in the refrigerator, away from the door if it
is opened frequently, is advisable.
• Carefully warm and resuspend the product according to the
directions given in the package insert. Proper mixing is
essential for accurate results.
• Check the open-tube stability dating and do not use
products longer than is recommended, or results may be
compromised.
• Never subject a tube to excessive heat or agitation.

Assay Verification
New lots of control material should be analyzed in parallel with
current lots prior to their expiration dates. This may be
accomplished by running the new controls twice a day for five
days. The mean of the ten runs is then used to confirm the assay
value. A control file is set up for the new lot number to easily
establish the mean. If desired, this same control file can then be
used to run the control for the remainder of the dating period.
Creating another file is not required.
The expected ranges published by manufacturers are generally too
broad for effective quality control.1 Therefore, each laboratory
should establish acceptable ranges. These ranges may be
determined by evaluating three to six months of data (data from the
Interlaboratory QC Program may be used) for a particular level of
control. The individual SD values may be averaged as follows:

(N1 ×
(N1 x SD12)
SD12)+ (N2 x×
+(N2 SD2
SD222))+.
+. . (Ni×
(Ni
... xSDi2)
SD2 )
Average SD =
(N1(N+
1+NN22+ ..
.Ni)
+ ...Ni) -- 1 1

N = number of values in a group


SD = Standard Deviation of the values in that group
i = the last group of values
The resultant long-term instrument SD and the laboratory-
established mean for each lot number should be used to monitor
instrument performance.
NOTE: Entry of the laboratory-established ranges is
restricted by the allowable limits available in the QC Range
Entry Screen. An explanation of this screen is provided in
Chapter 5: Operating Instructions, subsection: Set Up
Instructions, QC Limits Soft Key.

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Westgard Rules
A control rule tests the control result against control limits to
determine whether the CELL-DYN 3700 System shows acceptable
accuracy and precision. The limits are derived from the mean and
standard deviation of control measurements obtained when
instrument performance is stable and acceptable. The most
common rule used in hematology quality control is the mean
± 2SD limits. Ninety-five percent of the control results should fall
within the ± 2SD limits.
Quality control rules detect random or systematic error. Random
error may be defined as an increase in the SD (loss of precision).
Systematic error may be defined as a shift in the mean value (loss
of accuracy). A multi-rule quality control procedure combines
several control rules to improve the detection of both types of
error.
J. Westgard recommended a multi-rule approach to evaluating
quality control results.2 This approach has long been used in the
clinical laboratory3. A set of modified Westgard Rules can be used
to monitor quality control results on the CELL-DYN 3700 System.
NOTE: Do not use the values for mean range provided on
the control assay sheet in conjunction with Westgard
Rules. Before using Westgard Rules with commercial
controls, establish the SD for each parameter on your
instrument and enter limits based on these SDs. Refer to
Assay Verification within this section for how to establish
a long-term SD.

CELL-DYN 3700 System Westgard Rules


The rules (Westgard’s nomenclature is given in parentheses)
available on the System Software are:
Rule 1 (13s): Value outside 3SD
A control result exceeded the mean ± 3SD.
Rule 2 (22s): Two consecutive values outside the same 2SD
Two consecutive results fell outside 2SD on
the same side of the mean.
Rule 3 (R4s): Two consecutive values outside opposite 2SD
One result was greater than 2SD above the
mean and the next result was greater than 2SD
below the mean. Consequently, the range
between the results is greater than 4SD.
Rule 4 (2 of 32s): Two of three consecutive values outside
same 2SD
Two consecutive results of the last three
results fell outside 2SD on the same side of the
mean.

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Rule 5 (41s): Four consecutive values outside same 1SD


Four consecutive results fell outside 1SD on
the same side of the mean.
Rule 6 (10x): Ten consecutive values on the same side of mean
Ten consecutive results fell on the same side
of the mean.
The rules may be used singly or in combination, depending on
operator preference. Selections are made on the QC FILE SET UP
screen.
When a rule is selected, a plus sign is displayed to the right of the
parameter name on the LEVEY-JENNINGS MENU screens. (See the
following figure.) Six plus signs indicate that all six rules are
selected in order from left to right. A minus sign is displayed if a
rule is not selected.

QC file: Patient LEVEY-JENNINGS MENU Dec 15 1998 15:06


Seq num: 14 to 42 Ready Operator ID sh
Sequence # 0630
WBC:+-+-+6 WOC:+-+-+6 WIC:+-+-+6

4.80 4.80 4.80

4.40 4.40 4.40

4.40 4.40 4.40

RBC:+-+-++ HGB:+-+-+6 MCV:+-+-++

5.14 16.0 104.


4.90 15.3 99.3
4.66 14.6 94.4

PLT:+-+-++

248.
226.
204.

GROUP GROUP GROUP PRINT RETURN


2 3 4

Figure 7.9: Levey-Jennings Menu Screen Showing Westgard Rule Violations

Whenever a rule is violated, the Bulletin Line displays the


following message in the VIEW QC LOG screen:
WESTGARD WARNINGS: SEE LEVEY-JENNINGS.

The number of the rule that was violated is displayed in place of


the plus sign. The preceding figure shows examples of the plus
and minus signs and rule-violation indications.

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Rule Violations
Only the directly measured parameters need to be monitored with
multiple rules.4 In reference 4 (pp. 190–192), Cembrowski
suggests a protocol for using the Westgard Rules in hematology.
The following is a synopsis of that protocol.
Since three levels of control are typically used to monitor a
hematology analyzer, it is reasonable to consider all three runs at
the same time. In other words, check for rule violations across the
three levels, not just within a particular level. If the same rule is
violated for more than one level, determine whether the violation
indicates a loss of precision or a loss of accuracy, and troubleshoot
accordingly.
Cembrowski suggests that the results for all three levels first be
checked to see if they are within their 2SD limits. If all three levels
meet this criterion, the instrument is in control.
If any control result exceeds the 2SD limits, check to see if it
exceeds the 3SD limits. If a result exceeds 3SD, there are two
possibilities. There is either an instrument problem or a problem
with the particular level of control. Therefore, if a result exceeds
3SD, run another bottle of that control. If the problem persists,
then additional investigation is required.
Check to see if either the 2 of 32s or R4s rules have been violated
for any level or across levels. If the problem is confined to one
level of control, check for a 22s rule violation for that level. Again,
if the violations are confined to one level of control, use another
bottle and possibly another lot. Check expiration dates and data
entry. Check to be sure that the control is run into the correct file.
If a combination of rules has been violated across the three levels,
determine whether the violations indicate a loss of precision or a
loss of accuracy, and troubleshoot accordingly. If necessary, call
Abbott Diagnostics Customer Service (at 1-877-4ABBOTT in the
US) for assistance.
When the problem has been resolved, Cembrowski suggests that
all levels be run again in duplicate to confirm that the problem
has in fact been corrected.

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X-B Analysis
Overview
X-B analysis is an automated means of monitoring instrument
performance by using the known stability of the red cell indices.
“X-B” is used to indicate XB, which is the symbol for a moving
average of hematology values calculated using an algorithm
developed by Dr. Brian Bull of Loma Linda University. X-B RBC
analysis uses the Bull algorithm to monitor instrument performance
by tracking data in the patient population analyzed on the
instrument.
X-B RBC analysis works well using the data from the RBC indices
due to the narrow dynamic range of the indices in human
populations. However, it is difficult to use this approach when the
algorithm is applied to results that have a wide dynamic range of
values, such as the WBC Differential subpopulations.
Consequently, there has been no means of monitoring the WBC
Differential parameters in a similar manner.
A method of X-B analysis for WBC Differential parameters has been
developed for the CELL-DYN 3700 System using data obtained with
the MAPSSTM technology. This method uses a moving average
calculation that is similar to the one used in Dr. Bull’s algorithm. For
convenience, the method is called X-B WBC, even though it was not
developed by Dr. Bull. A detailed description is contained in X-B
Analysis for WBC within this chapter.

X-B Terminology

Lower/Upper Acceptance Limits


The lower and upper limits determine which patient results will
be used in the X-B Moving Average calculation. They should be set
widely to exclude grossly abnormal samples but should include at
least 95% of the patient results. Only results that fall within the set
limits are used in the calculation.

Target Value
The Target Value for X-B RBC is similar to the assay value for a
commercial control. It is derived from the patient population
analyzed on the instrument.

Action Limit
The Action Limit is the acceptable limit of variation around the
target value.

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X-B Analysis for RBC

Overview
The red cell indices (MCV, MCH, and MCHC) are known to be stable
because the red cell apparently functions best in a very narrow range
of size and hemoglobin content. Therefore, the body exerts tight
physiologic control and will vary the number of red cells before
altering the average volume or hemoglobin concentration of those
red cells. Consequently, the average red cell indices of a given patient
population will vary no more than 0.5 percent from day to day and
even year to year, providing the population does not change.5 The
X-B algorithm provides a means of utilizing this information for
quality control on the CELL-DYN 3700 System.
The X-B algorithm analyzes the indices on the patient samples run
through the instrument in batches of 20. The mean of each batch
is compared to a target value, and a percent deviation is
computed and compared to the acceptable limits. This is similar
to comparing the results of a commercial control run to the
appropriate assay value to determine whether the result falls
within the 2SD range. If the percent deviation exceeds acceptable
limits, the message: X-B OUT is displayed on the screen.

Establishing the X-B RBC Target Value


A recent study6 by Dr. Bull collected data from 1,767 hospitals and
yielded the following mean values:
MCV 89.9 fL
MCH 30.5 pg
MCHC 33.9 g/dL
These values confirmed values that Bull had published in an
earlier study.7 Consequently, the values shown above can be used
as the Target Values to initiate the X-B analysis program.
Laboratories seeing specialized patient populations (for example,
pediatric hospitals or tumor centers) may need to verify these
values due to “abnormal” patient populations. Target values may be
verified by evaluating approximately 500 samples and comparing
the X-B means for those samples to the entered target values.
The CV on 500 samples for each index should be < 1.5%. (Dr.
Bull’s study found CVs from 0.5% to 1.2%. The 1.5% is one-half
the allowable ± 3% action limit, which is acceptable for this
confirmatory step.) If the CVs are >1.5%, an additional 500
samples should be evaluated.

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Each laboratory should establish its own target value for the RBC
indices. It is suggested that the process be started by using the
default values (preset values from Dr. Bull’s earlier studies)
displayed on the X-B SET UP screen or by entering the values from
Dr. Bull’s recent study described above. The 3% action limits may
be used or widened to 5% during the study and tightened to 3%
when the Target Values are confirmed. The default values for the
Lower/Upper Limits may also be used or widened depending on
the specimen population analyzed by the laboratory.
Collect data from 20 batches of 20 specimens each for a total of
400 specimens. Data collection should be from specimens which
represent the typical specimen population that is processed
through the instrument. When all 20 batches are complete, print
the X-B DATA DISPLAY screen for RBC. Calculate the mean, standard
deviation (SD), and coefficient of variation (CV) for MCV, MCH,
and MCHC. The CV for each index should be < 1.5%. If the CV for
each index meets these criteria, enter the calculated mean value as
the target value and set the action limits to 3%.
NOTE: Laboratories analyzing specialized patient
populations (as described above) may need to widen the
action limits slightly to accommodate results from these
abnormal patients.

If the CV for each index is >1.5%, evaluate another 400 specimens


and repeat the calculations.
When an acceptable target value has been entered, evaluate data
from an additional 400 specimens to confirm the entered values.

Troubleshooting X-B RBC Results


When XB-RBC results are out of control, data should be reviewed
for shifts and trends in the results.
Shifts in results are usually caused by a non-random batch of 20
specimens such as those from dialysis or pediatric units. Multiple
repeats of the same abnormal specimen within a given batch of 20
may also cause a non-random population in that batch. Review
the Data Log for the last 20 specimens and determine if this is the
case. Shifts caused by non-random data will usually be corrected
in the next batch of 20 as long as those data are random.
Shifts may also be caused by a change in reagent container or a lot
number change. Review the Reagent Log to see if this is true for
Diluent or WIC/HGB Lyse. If containers or lot numbers recently
changed, try another container and see if the problem persists.

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Calibration changes may also cause a shift in results. If a shift


cannot be explained as described above, run commercial controls
or run a patient selected from a previous batch when X-B results
were in control. If values are within acceptable limits, a
calibration shift is not the cause of the problem.
Trends in X-B results are usually caused by instrument problems.
A recent component change may also cause a trend in results. Use
the following table to determine the directly measured
parameter(s) involved, and troubleshoot accordingly. If a problem is
not readily identified, perform routine maintenance and repeat
the commercial and patient controls to see if results are acceptable.
Since two of the RBC indices are calculated parameters, their inter-
relationships can be used to assist in troubleshooting. The
following table uses the mathematical relationships between the
indices to aid in determining which directly measured
parameter(s) are involved when X-B is out of control. When the
directly measured parameter(s) are identified, refer to Chapter 10:
Troubleshooting for troubleshooting assistance with these
parameters.
Table 7.1: Troubleshooting X-B RBC

If the MCV If the RBC If the HGB


X-B is is is is is is Index
Pattern increased decreased increased decreased increased decreased Derivation

MCV High Low N/A N/A N/A N/A MCV


will be
MCH N/A N/A Low High High Low HGB/RBC
will be
MCHC Low High Low High High Low HGB/HCT
will be

If all efforts fail to bring results within acceptable limits, contact


Abbott Diagnostics Customer Service (at 1-877-4ABBOTT in the
US) for assistance.

Interpreting X-B RBC Results


A suggested protocol and guidelines for interpreting X-B data can
be found in Chapter 1 of Laboratory Hematology: An Account of
Laboratory Techniques, edited by I. Chanarin.8

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X-B Analysis for WBC

Overview
Since the WBC Differential parameters have a wide dynamic
range, it is difficult to use a moving average algorithm to control
these results. Therefore, the CELL-DYN 3700 System uses data
obtained from the MAPSSTM technology used for the WBC
Differential measurement.
Five main subpopulations of WBCs, which can vary widely in
absolute number and percentage values, are identified by the
CELL-DYN 3700 System. Even though these parameters have varying
dynamic ranges, they maintain a relatively constant modal position
on each axis of the scatterplots. It is expected that these optical
characteristics of the WBC Differential subpopulations will remain
stable over time without impact from the wide dynamic ranges of the
individual parameters. This constant modal position, which is
sensitive to changes in the instrument’s optical measurement
process, can be monitored by the instrument and used to control the
WBC Differential parameters in much the same way that the RBC
indices are used to control the RBC parameters.
The CELL-DYN 3700 System monitors the modal positions of the
lymphocyte and neutrophil clusters on each axis of the 0°/10°
scatterplot. It also monitors the modal positions of the neutrophil
cluster on each axis and the angle of the neutrophil/eosinophil
separation on the 90°/90° depolarized scatterplot. These seven
measurements are then averaged for each batch of 20 patients using a
moving average calculation similar to that developed by Dr. Bull for
the RBC indices. For convenience, this process is called X-B WBC.

Establishing the X-B WBC Target Value


The Target Values for X-B WBC can be established in the same way
as the Target Values for the RBC indices.
Each laboratory should establish its own target value for the X-B WBC
parameters. It is suggested that the process be started by using the
default (preset) values displayed in the following table. The action
limits in the table may be used or widened during the study. Reenter
the default action limits shown in the following table when the Target
Values are confirmed. The values for the action limits may be widened
depending on the specimen population analyzed by the laboratory.
The values for the Lower/Upper Acceptance Limits may also be used or
widened depending on the specimen population analyzed by the
laboratory.

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9140320C — November 2000
Quality Control
Chapter 7 Quality Control Guide

Collect data from 20 batches of 20 specimens each for a total of


400 specimens. Data collection should be from specimens which
represent the typical specimen population that is processed
through the instrument. When all 20 batches are complete, print
the X-B DATA DISPLAY screen for WBC. Calculate the mean,
standard deviation (SD), and coefficient of variation (CV) for each
parameter. The CV for LYM 0°, LYM 10°, NEU 0°, and NEU 10°
should be <2.5%. The CV for NEU 90°, NEU 90° depolarized, and
NEU-EOS should be <5%. If the CV for each index meets these
criteria, enter the calculated mean value as the target value and set
the action limits to 5% for LYM 0°, LYM 10°, NEU 0°, and NEU 10°,
and to 10% for NEU 90°, NEU 90° depolarized, and NEU-EOS.
NOTE: Laboratories analyzing specialized patient
populations (as described above) may need to widen the
action limits slightly to accommodate results from these
abnormal patients.
If the CV for each index is more than the limits described above,
evaluate another 400 specimens and repeat the calculations.
When an acceptable target value has been entered, evaluate data
from an additional 400 specimens to confirm the entered values.

Table 7.2: Default (Preset) X-B WBC Values


Parameter Acceptance Limits Target Mean Action Limit
LYM 0° 48 - 70 59 7
LYM 10° 51 - 67 59 5
NEU 0° 141 - 179 160 4
NEU 10° 128 - 170 149 5
NEU 90° 87 - 163 125 10
NEU 90 DEP° 11 - 31 21 19
NEU-EOS° 14 - 32 23 13

CELL-DYN® 3700 System Operator’s Manual 7-25


9140320D — June 2003
Quality Control
Quality Control Guide Chapter 7

Troubleshooting X-B WBC Results


Troubleshooting X-B WBC results that are out-of-range can be
done using the same logic that is applied to troubleshooting X-B
RBC out-of-range results. Review previous batches of data for non-
random specimens, check the appropriate reagents, run controls
to determine whether a calibration change has occurred, check to
see if service was recently performed on the optical system or a
component was recently changed, perform appropriate routine
maintenance procedures, and refer to Chapter 10:
Troubleshooting for assistance.
If all efforts fail to bring results within acceptable limits, contact
Abbott Diagnostics Customer Service (at 1-877-4ABBOTT in the
US) for assistance.

7-26 CELL-DYN® 3700 System Operator’s Manual


9140320E — September 2004
Chapter 7 Quality Control

References

1. Cembrowski GS, Carey RN. Laboratory Quality Management.


Chicago: ASCP Press. 189. 1989.
2. Westgard JO et al. A Multi-Rule Shewhart Chart for Quality
Control in Clinical Chemistry. Clinical Chemistry 1981;
27:3:493–501.
3. Cembrowski GS, et al. Use of a Multirule Control Chart for
the Quality Control of PT and APTT Analyses. Laboratory
Medicine June 1989; 418–421.
4. Cembrowski GS, Carey RN. Laboratory Quality Management.
Chicago: ASCP Press. 190. 1989.
5. Bull BS, Korpman RA. Intralaboratory Quality Control Using
Patients’ Data. Quoted in Cavill I, ed, Quality Control
(Edinburgh: Churchill Livingstone, 1982), 121–150.
6. Bull BS, Jones AR, Gibson M, Twedt D. A Method for the
Independent Assessment of the Accuracy of Hematology
Whole Blood Calibrators. American Journal of Clinical
Pathology 1992; 98:623-29.
7. Bull BS, Hay KL. Are Red Blood Cell Indexes International?
Archives of Pathology and Laboratory Medicine 1985; 109:
604–606.
8. Chanarin I, ed. Laboratory Hematology: An Account of Laboratory
Techniques. New York: Churchill Livingstone. 3-7. 1989.

CELL-DYN® 3700 System Operator’s Manual 7-27


9140320C — November 2000
Quality Control
References Chapter 7

NOTES

7-28 CELL-DYN® 3700 System Operator’s Manual


9140320C — November 2000
Chapter 8 Hazards
Hazards

Overview

Hazards

Operation, maintenance, and servicing of automated hematology


systems may expose individuals to potential safety and health
hazards. All work must be performed as described in the Abbott
Laboratories CELL-DYN Operator’s Manual or as directed by an
Abbott Representative.
This section provides precautionary warnings and information
necessary for the safe use of the CELL-DYN 3700 System.
Supplementary warnings are inserted throughout this manual and
on the instrument to alert personnel to potential hazards.
Whenever hazard symbols are encountered on the instrument,
users must consult the Operator’s Manual to determine the nature
of the potential hazard and actions that must be taken.
The standard warning conventions including signal words (e.g.,
caution) and symbols are described below. Safety symbols appear
next to signal words that identify hazards.

Warning Conventions
Signal Words

DANGER: Denotes an immediate hazard which, if not


avoided, could result in serious injury or death.
WARNING: Denotes a hazard which, if not avoided, could
result in moderate to serious injury.
CAUTION: Denotes potential hazards that could result in a
minor injury. Also, used for conditions or activities
which could interfere with proper functioning of
the instrument.
NOTE: Denotes special operator/service information or
standard practices.

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9140320D — June 2003
Hazards
Overview Chapter 8

Symbols
The general hazard symbol identifies an activity or
area that may present a hazard to personnel or
equipment.

The electrical hazard symbol alerts personnel to


the possibility of electrical shock if procedural or
engineering controls are not observed.

The biohazard symbol identifies an activity or area


where personnel may be exposed to infectious
substances if procedural engineering controls are
not observed.

The laser hazard symbol identifies an activity or


area where personnel will be exposed to an eye
hazard if procedural or engineering controls are
not observed.

8-2 CELL-DYN® 3700 System Operator’s Manual


9140320D — June 2003
Hazards
Chapter 8 Hazard Information and Precautions

Hazard Information and Precautions

General
Automated hematology instruments require the handling of whole
blood and blood components by laboratory personnel. In
addition, personnel must conduct maintenance to ensure proper
performance of the instrument. These activities result in potential
contact with infectious substances and other hazards. The
following are warnings, precautions, and standard practices to
help prevent injury.

CAUTION: If the instrument is used or modified in


a manner not specified by the manufacturer, the
protection provided by the instrument may be
impaired.

Biohazards
WARNING: Potential Biohazard. Consider all
clinical specimens, reagents, controls, surfaces or
components that contain or have contacted blood,
serum, or other bodily fluid as potentially
infectious. Wear gloves, lab coats, and safety glasses,
and follow other biosafety practices as specified in
the OSHA Bloodborne Pathogen Rule (29CFR Part
1910.1030) or other equivalent biosafety
procedures.

WARNING: Potential Biohazard. The aspiration


needle and probe are sharp and potentially
contaminated with infectious material. Avoid
contact with the tips of the probe and needle.

Spills of potentially infectious materials should be cleaned up in


accordance with established biosafety practices. A generally
accepted procedure for cleaning such spills is to absorb the spill
with toweling or other absorbent material, wipe the area with an
appropriate tuberculocidal disinfectant such as 0.5% sodium
hypochlorite solution (refer to formula in Chapter 9:
Maintenance, Subsection: Decontamination Procedures).

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9140320D — June 2003
Hazards
Hazard Information and Precautions Chapter 8

Prior to maintenance, service, or shipping, the instrument should


be decontaminated in accordance with the procedures specified in
Chapter 9: Maintenance, Subsection: Decontamination
Procedures and/or Preparation for Inactivity or Shipping as
appropriate. Remove and dispose of contaminated disposables in
accordance with local, state, and federal regulations.

Handling and Disposing of Biohazardous Materials


Dispose of liquid and solid waste in accordance with local, state,
and federal regulations. Probes, needles, broken glass, and other
sharps that are contaminated with potentially infectious
substances should be collected in a “sharps” container for disposal
as regulated medical waste. Contaminated gloves, wipes, swabs,
and other disposables should be placed in a standard medical waste
container.

Chemical Hazards
Prevent exposure to chemicals used in the operation and
maintenance of the CELL-DYN 3700 System (including reagents)
by using appropriate personal protective equipment, work
procedures, and information on Material Safety Data Sheets
(MSDS). Refer to Chapter 2: Installation, for an installation
procedure for chemical containers.

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9140320D — June 2003
Hazards
Chapter 8 Hazard Information and Precautions

Electrical Hazards
Basic electrical hazard awareness is essential to the safe operation
of any hematology analyzer. Appropriate personnel (including
facilities personnel) should practice good habits of electrical
safety, which include the following:
• Periodically inspect electrical cabling into and on the
instrument for signs of wear or damage.
• When moving equipment, lift all power cables clear of all
System components.

CAUTION: Electrical Hazard. Do not disconnect any


electrical connection while the power is on. Follow
instructions for correctly powering down the instrument
and all connected equipment before performing
maintenance on parts which require protective covers to be
removed for access. Use only approved power cords and
electrical accessories, supplied with the instrument, or
provided by Abbott, to protect against electrical shock.

CAUTION: Electrical Hazard. Turn off the power to the


instrument and disconnect the power cord before removing
any instrument panel that is securely fastened in place by
screws or prior to replacing fuses. Replace only the
externally accessible fuse located immediately above the
power cord connector on the rear panel of the instrument.
Use replacement fuses only of the specified type and
electrical rating.

• Keep liquids away from all electrical connectors (such as


electrical outlets) or communication connectors (such as the
LIS connector).
• Keep the floor dry.
• The electrical circuit spacing of the CELL-DYN 3700 System is
based on pollution degree (1) and altitude [up to 2000 M
(6500 ft)] as per IEC 61010-1. Pollution degree 1 is defined as
an environment where there is no pollution or only dry, non-
conductive pollution.

CAUTION: If the instrument is used or modified in a


manner not specified by the manufacturer, the protection
provided by the instrument may be impaired.

For details about power requirements, refer to Chapter 4: System


Specifications, Subsection: Power Specifications.

CELL-DYN® 3700 System Operator’s Manual 8-5


9140320D — June 2003
Hazards
Hazard Information and Precautions Chapter 8

Physical and Mechanical Hazards


Observe these basic rules for mechanical safety:
• Carefully follow all procedures and instructions.
• Keep all protective covers in place when processing
specimens.
• Never allow any part of your body to enter the region of
movement of any mechanical component when the
instrument is operating.
• Do not wear articles of clothing or accessories that could
catch on the System; keep pockets free of items that could fall
into the System; keep long hair from catching on the System.
• Wear powder-free gloves, labcoat and safety glasses when
maintaining or repairing the instrument.
• Avoid contact with needle tips at all times.
• Use professional assistance when moving or lifting the
instrument, to prevent injury.
• Use proper lifting technique to prevent injury when moving
reagent cubtainers.

Laser Hazards
The CELL-DYN 3700 Analyzer and Sample Loader are Class 1
(Class I) Laser Products per IEC 60825-1. However, the analyzer
contains Class 3B and Class 2 lasers as well.

CAUTION: Class 3B Laser Light when open — Avoid


Exposure to Beam. Do not look directly into the laser
beam or any reflections of the beam from a mirror-like
surface. When the access door, or other inner protective
covers are removed, Helium-Neon laser power up to 10
mW continuous wave at 632.8 nm in a beam with 1mR
divergence could be accessible in the interior of the optics
bench. This amount of energy, with insignificant
attentuation with distance, is sufficient to cause eye
damage. The laser aperture is located on the left end of the
laser head (refer to Figure 8.3). This Class 3B laser system
is classified to EN 60825-1/A2:2001, the standard for
Safety of Laser Products.

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9140320D — June 2003
Hazards
Chapter 8 Hazard Information and Precautions

CAUTION: Barcode Laser Light —Do not stare into


beam. Do not stare directly into the barcode laser beam or
any reflections of the beam from a mirror-like surface. The
laser beam is capable of causing eye damage. When the
Left Front Cover or the Tower Cover is removed, Class 2
laser light up to 1 mW continuous wave at 670 nm could
be accessible from the bar code reader. The bar code reader
is located behind the Tower Unit. The laser aperture is
located on the right side of the bar code reader. This Class
2 laser system is classified to EN 60825-1:1994+All:1996,
the standard for Safety of Laser Products. The Class 2 Laser
Label applies only to the CELL-DYN 3700SL.

CAUTION: Use of controls adjustments or performance of


procedures other than those specifified herein may result
in hazardous laser light exposure. The sample loader’s
safety cover has an interlock switch that prevents sample
loader operation when the cover is not in place. Lifting the
cover while the sample loader is operating causes an
immediate emergency stop condition. Do not bypass the
interlock switch to operate the sample loader without the
safety cover.

During normal operation the inner protective covers are to remain


in place to prevent laser light exposure from the optics bench. The
inner protective covers should be removed only during servicing
by qualified personnel.
The inner protective cover laser warning labels must not be
removed and are to remain legible. The protective housing label
(Abbott P/N 9230701), shown in Figure 8.1 consists of black
lettering against a yellow background.

CELL-DYN® 3700 System Operator’s Manual 8-7


9140320D — June 2003
Hazards
Hazard Information and Precautions Chapter 8

CAUTION –
CLASS 3B LASER LIGHT WHEN OPEN.
AVOID EXPOSURE TO BEAM.
PN 9230701

Figure 8.1: Laser Hazard Label

This label is located in two places: on the L-shaped optical baffle


cover on the left side of the optical bench (under the Top Cover)
(refer to Figure 8.2), and on the upper left side of the Flow Panel
(refer to Figure 8.3).

Laser Aperture Laser Warning Label

Protective
Cover

Figure 8.2: Laser Aperture and Warning Label Position -


Protective Cover

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9140320D — June 2003
Hazards
Chapter 8 Hazard Information and Precautions

Laser Warning Label

Figure 8.3: Laser Warning Label Position - Flow Panel

The Class 2 Laser Caution Label (Abbott P/N 9230323) is shown in


Figure 8.13. The label consists of black lettering against a yellow
background.
CAUTION - CLASS 2 LASER LIGHT WHEN
OPEN AND INTERLOCK IS DEFEATED
DO NOT STARE INTO THE BEAM
PN 9230323

Figure 8.4: Class 2 Laser Caution Label

This label is located on the top surface of the sample loader. (Refer
to Figure 8.5.

Class 2 Laser
Caution Label
Figure 8.5: Class 2 Laser Caution Label Location

CELL-DYN® 3700 System Operator’s Manual 8-9


9140320D — June 2003
Hazards
Hazard Information and Precautions Chapter 8

The Class 1 Laser Product Label (Abbott P/N 9230702) shown in


Figure 8.6 consists of black lettering against a yellow background.

CLASS 1 LASER PRODUCT


PN 9230702

Figure 8.6: Laser Label, Rear Panel

The label is located on the left section of the instrument’s Rear


Panel and is positioned in a clearly visible location, as shown in
Figure 8.7.

Class 1 Laser
Product Warning
Label

Figure 8.7: Class 1 Laser Product Label Location

8-10 CELL-DYN® 3700 System Operator’s Manual


9140320D — June 2003
Hazards
Chapter 8 References

References

1. Occupational Safety and Health Administration, Department


of Labor. 29 CFR Part 1910.1030. Occupational Exposure to
Bloodborne Pathogens.
2. IEC 60825-1, International Electrotechnical Commission —
World Standards for Electrical and Electronic Engineering,
60825: — Safety of Laser Products, 60825-1 (1993) Part 1:
Equipment Classification, Requirements, and Users Guide.

CELL-DYN® 3700 System Operator’s Manual 8-11


9140320D — June 2003
Hazards
References Chapter 8

NOTES

8-12 CELL-DYN® 3700 System Operator’s Manual


9140320D — June 2003
Chapter 9 Maintenance
Maintenance

Overview

The CELL-DYN® 3700 System is designed to require minimal


routine maintenance. For example:
• The fluidics are automatically rinsed between samples.
• A thorough system rinse is performed automatically when
the unit has been idle for five minutes after the last cycle is
completed.
• An automatic Aperture Cleaning Circuit cleans the WIC
aperture after each count cycle.
• The instrument is automatically placed in STANDBY if it has
been idle for four hours after the last cycle is completed.
The operator is encouraged to routinely perform the scheduled
maintenance procedures described in this chapter in order to
ensure optimum performance. This chapter also give instructions
for preparing the instrument for a prolonged period of inactivity.
Many required preventive maintenance procedures have been
automated on the CELL-DYN 3700 System. These programs can
be accessed by pressing the [SPECIAL PROTOCOLS] key on the Data
Station. The SPECIAL PROTOCOLS screen is discussed in the next
section.

The maintenance schedule outlined on the following page will


minimize operational problems with the CELL-DYN 3700 System.
The recommended intervals are based on instruments operating in
laboratories that process samples from a general patient population.
The intervals are affected by the volume of samples processed, the
workload schedule, the operating environment and the patient
population that is analyzed. Each laboratory must assess its own
situation and modify these recommended intervals as necessary.

Overdue maintenance is usually indicated by an increase in


imprecision of one or more of the directly measured parameters.
This increase is due to carryover or dilution/sampling
inconsistencies. If this occurs on more than a random basis, the
appropriate maintenance should be performed more frequently.
A diagram of the Analyzer Flow Panel is included to assist in
component identification and location.

CELL-DYN® 3700 System Operator’s Manual 9-1


9140320C — November 2000
Maintenance
Overview Chapter 9

Preventive Maintenance Schedule


The following procedures should be performed at the scheduled
time intervals or as determined by each individual laboratory:

Daily
1. Run the Auto-Clean Cycle.
2. Clean the Aspiration Needle.

Weekly
1. Clean the Shear Valve.
2. Replace the Sample Aspiration Peristaltic Pump Tubing.
3. Clean the Sample Loader Tray, Racks, and Safety Cover.
4. Run the Extended Auto-Clean Cycle if routinely running
reticulocyte counts.

Monthly
1. Clean the Reagent Syringes.
2. Clean the Analyzer Air Filters.
3. Replace the WOC Transfer Peristaltic Pump Tubing.
4. Run the Extended Auto-Clean Cycle.

As Required (for Troubleshooting or Corrective Action)


1. Clean the 10-mL Reagent syringe.
2. Clean the WIC and RBC/PLT Aperture Plates.
3. Clean the HGB Flow Cell.
4. Unclog the Open Sample Aspiration Probe.
5. Clean the Bar Code Reader Window.
6. Flush the "Y" Fitting.

Special Procedures
1. Adjust the Closed Sampler Tube Retainer (CS only).
2. Prepare for Inactivity or Shipping.
3. Repackage for Shipment.

Analyzer Flow Panel Components Diagram


A diagram of the Analyzer Flow Panel components has been
included on the next page. This diagram can be used to assist in
locating components.

9-2 CELL-DYN® 3700 System Operator’s Manual


9140320E — September 2004
Grounding WOC Mixing Sample Aspiration Mounting
Mounting Wire Clip Chamber A.C.C. Interlock Switch Grounding
Peristaltic Pump Bracket Wire Clip
Bracket

Figure 9.1:
Chapter 9

Overflow
Chamber
Optical
Aerosol WOC Flow Mounting Bench
Filter Cell Cover Bracket Assembly

9140320E — September 2004


von Behrens
WIC

CELL-DYN® 3700 System Operator’s Manual


Transducer
Assembly
Normally
Closed
Shear Valve Valves
WOC Transfer Assembly
Peristaltic Pump

Analyzer Flow Panel Components


Wash
Block

HGB
Flow Cell

WIC Metering
Assembly

Mounting Open
Bracket Sample
Aspiration
Probe
von Behrens
RBC/PLT
Transducer
Assembly
Touch
Waste Plate
Chamber 1
Vacuum WOC Metering Syringe RBC/PLT Diluent Syringe
(contains Sheath Reagent) HGB/WIC Lyse Syringe (contains Diluent)
RBC/PLT Accumulator (contains HGB/WIC Lyse)
Diluent Drain Line RBC/PLT Waste
Overpressure Chamber 2 WOC Sheath Syringe HGB/WIC Diluent Syringe
Metering
Sensor Assembly (contains Sheath Reagent) (contains Diluent)
Overview
Maintenance

9-3
Maintenance
Overview Chapter 9

Decontamination Procedures
The OSHA Bloodborne Pathogen Rule (29 CFR Part 1910.1030)
requires the decontamination of laboratory equipment prior to
servicing or shipment:
• Decontaminate the instrument by performing the Auto-
Clean cycle. This cycle flushes all of the fluid pathways with
reagents to purge any waste from the fluid pathways. The
Open Mode Sample Probe and the Closed Sample Needle (CS
Model) or Sample Loader Needle (SL Model) are
automatically rinsed after every cycle. The surfaces of the
instrument should be wiped with a nonabrasive detergent
solution to remove any soiling, then wiped with a
tuberculocidal disinfectant, such as a 0.5% sodium
hypochlorite solution.
To calculate the percent (%) sodium hypochlorite concentration
desired see the following formula:
A = Percent (%) of sodium hypochlorite solution desired
B = Percent (%) of sodium hypochlorite stock solution (as
purchased)
X = Parts of water to be mixed with one part of the sodium
hypochlorite stock solution

B-A
X=
A

Example:
If you need a 0.5% solution of sodium hypochlorite for a cleaning
procedure, and the label on the bottle of bleach states that it is
5.25% sodium hypochlorite, then:

5.25 - .5
X= X = 9.5
.5

Add 9.5 parts deionized water to 1 part bleach to obtain a 0.5%


sodium hypochlorite solution, or 9.5 mL of deionized water to 1.0
mL of bleach (5.25% sodium hypochlorite) to obtain 10.5 mL of a
0.5% solution of sodium hypochlorite.
If the instrument is to be shipped, it must be decontaminated
prior to shipment. This is accomplished by pressing the [PREPARE
SHIPPING] key in the SPECIAL PROTOCOLS menu. Instructions for
this procedure are given in Special Procedures, Subsection:
Preparation for Inactivity or Shipping.

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9140320D — June 2003
Maintenance
Chapter 9 Special Protocols Menu

Special Protocols Menu

SPECIAL PROTOCOLS Nov 20 1998 16:01


Ready Operator ID rcs
Sequence # 0711

EMPTY REAGENT EMPTY MAINTEN CLEAN DISABLE MORE MAIN


XDUCERS RESERVOIR WOC LOG SHEAR VAL ANALYZER

Figure 9.2: Special Protocols Screen

SPECIAL The SPECIAL PROTOCOLS screen is accessed from the MAIN MENU
PROTOCOLS screen by pressing the [SPECIAL PROTOCOLS] key. The following
soft key labels are displayed:
EMPTY XDUCERS or
FILL XDUCERS (The soft key label alternates
between these two selections.)
REAGENT RESERVOIR
EMPTY WOC or FILL WOC (The soft key label alternates
between these two selections.)
MAINTEN LOG
CLEAN SHEAR VAL or
RESTORE SHEAR VAL (The soft key label alternates
between these two selections.)
DISABLE ANALYZER or
ENABLE ANALYZER (The soft key label alternates
between these two selections.)
MORE
MAIN

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9140320C — November 2000
Maintenance
Special Protocols Menu Chapter 9

A brief description of the function of each soft key follows.


Instructions for the detailed use of each key are given in the
appropriate maintenance procedure.

Emptying the Transducers


EMPTY The [EMPTY XDUCERS] key is used to empty both chambers in the
XDUCERS von Behrens WIC Transducer and both chambers in the von
Behrens RBC/PLT Transducer prior to removing the Aperture
Plates. When the transducers are empty, the key label changes to
[FILL XDUCERS].

FILL When the [FILL XDUCERS] key is pressed, the transducers are
XDUCERS refilled with reagent.

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Maintenance
Chapter 9 Special Protocols Menu

Draining the Reagent Reservoirs

REAGENT RESERVOIR Nov 20 1998 16:01


Ready Operator ID rcs
Sequence # 0711

Press the appropriate EMPTY soft key to empty the reagent reservoir.
Stay on this screen until the "FILL" key appears
After the appropriate FILL soft key is displayed, remove reagent line
from existing container and place in new container.

Press the FILL soft key to fill the reagent reservoir.

Run 5 background cycles.


Confirm background results are acceptable before running samples.

EMPTY EMPTY EMPTY EMPTY RETURN


DILUENT LYSE SHEATH DETERGENT

Figure 9.3: Reagent Reservoir Screen

REAGENT The [REAGENT RESERVOIR] key is used to drain the reagent reservoirs
RESERVOIR located on the Left Side Panel of the Analyzer. When the [REAGENT
RESERVOIR] key is pressed, the following soft key labels are displayed:
EMPTY DILUENT or FILL DILUENT
EMPTY LYSE or FILL LYSE
EMPTY SHEATH or FILL SHEATH
EMPTY DETERGENT or FILL DETERGENT
RETURN
The screen displays the message shown in the preceding figure.
When the [EMPTY DILUENT], [EMPTY DETERGENT] or [EMPTY SHEATH] key
is pressed, the appropriate reagent reservoir is drained. The [EMPTY
LYSE] key is used to drain the WIC/HGB Lyse supply tubing. When the
reservoir (or tubing) is empty, the appropriate [FILL] key is displayed.
When the [FILL DILUENT], [FILL DETERGENT] or [FILL SHEATH] key is
pressed, the appropriate reagent reservoir is refilled. When the
[FILL LYSE] key is pressed, the lyse supply tubing is refilled.

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9140320C — November 2000
Maintenance
Special Protocols Menu Chapter 9

Draining the Optical Flow Cell


EMPTY The [EMPTY WOC] key is used to drain the reagent from the WOC
WOC Flow Cell. When the Flow Cell is empty, the key label changes to
[FILL WOC]. When the [FILL WOC] key is pressed, the Flow Cell is
refilled with reagent.

Accessing the Maintenance Log


MAINTEN The [MAINTEN LOG] key is used to set up, review, and print the
LOG Maintenance Log. If the Maintenance Log feature is used, the screen
displays a Bulletin Line prompt when scheduled maintenance
should be performed. The Maintenance Log Set Up Procedure and
the Maintenance Log screens are discussed in Maintenance Log
Set Up within this chapter.
When the [MAINTEN LOG] key is pressed, the following soft key
labels are displayed:
INTERVAL SET UP
UPDATE LOG
PRINT & PURGE
PRINT LOG
RETURN

INTERVAL The [INTERVAL SET UP] key is used to configure the maintenance
SET UP schedule.

UPDATE The [UPDATE LOG] key is used to indicate when maintenance was
LOG performed and to add comments to the Maintenance Log.

PRINT & The [PRINT & PURGE] key is used to print the completed log and
PURGE then delete it. When the [PRINT & PURGE] key is pressed, the
following soft key labels are displayed:
CONFIRM
CANCEL
These keys are used to [CONFIRM] or [CANCEL] the Print & Purge
command.

PRINT The [PRINT LOG] key is used to print the Maintenance Log.
LOG

RETURN The [RETURN] key is used to return to the main SPECIAL


PROTOCOLS screen.
A detailed Maintenance Log Set Up Procedure and illustrations of
the Maintenance Log screens are presented at the end of this section.

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Maintenance
Chapter 9 Special Protocols Menu

Accessing the Shear Valve


CLEAN The [CLEAN SHEAR VAL] key is used to prepare the Shear Valve for
SHEAR VAL cleaning. When the key is pressed, the syringes partially empty,
which flushes the reagents out of the Shear Valve and the
associated tubing. The Shear Valve then rotates into the position
necessary for its removal. When the rotation is complete, the key
label changes to [RESTORE SHEAR VAL].

RESTORE When the [RESTORE SHEAR VAL] key is pressed, the syringes refill
SHEAR VAL the Shear Valve and the associated tubing, and the Shear Valve
rotates back to its operational position. When the rotation is
complete, the key label changes to [CLEAN SHEAR VAL].

Disabling/Enabling the Analyzer


DISABLE The [DISABLE ANALYZER] key is used to prevent the Analyzer from
ANALYZER cycling while certain maintenance procedures are performed.
When the Analyzer is disabled, the key label changes to [ENABLE
ANALYZER].

ENABLE When the [ENABLE ANALYZER] key is pressed, the Analyzer is


ANALYZER returned to the READY state.

SPECIAL PROTOCOLS Nov 20 1998 16:01


Ready Operator ID rcs
Sequence # 0711

FLUSH AUTO DAILY PREPARE CLEAN EXTEND MORE MAIN


SHEATH CLEAN SHUTDOWN SHIPPING NEEDLE AUTOCLEAN

Figure 9.4: Special Protocols Screen 2

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Maintenance
Special Protocols Menu Chapter 9

Special Protocols Screen #2


MORE When the [MORE] key on the SPECIAL PROTOCOLS screen is
pressed, the second SPECIAL PROTOCOLS screen and the following
soft key labels are displayed:
FLUSH SHEATH
AUTO CLEAN
DAILY SHUTDOWN
PREPARE SHIPPING
CLEAN NEEDLE
EXTEND AUTOCLEAN
MORE
MAIN

FLUSH The [FLUSH SHEATH] key is used to flush the WOC Flow Cell with
SHEATH Sheath Reagent.

AUTO The [AUTO CLEAN] key is used to initiate the Auto-Clean Cycle. The
CLEAN Shear Valve, the WOC Mixing Chamber, the WOC Flow Cell, the
von Behrens WIC Transducer, the von Behrens RBC/PLT
Transducer, the HGB Flow Cell and all of the associated fluidics
are automatically cleaned and rinsed during the cycle.
When the [AUTO CLEAN] key is pressed, the screen displays the
message shown in Figure 9.8 in the Daily Maintenance section.
The following soft key labels are displayed:
START
CANCEL
These keys are used to [START] or [CANCEL] the Auto-Clean Cycle.

DAILY The [DAILY SHUTDOWN] key is used to initiate the Daily Shutdown
SHUTDOWN cycle. During the cycle, the fluidics are automatically drained and
rinsed. At the end of the cycle, the Analyzer is placed in STANDBY.
The electronic solenoid valves are automatically opened
periodically while the Analyzer is in STANDBY to prevent the
tubing from becoming pinched.

PREPARE The [PREPARE SHIPPING] key is used to prepare the Analyzer for
SHIPPING shipment or a period of inactivity. The cycle drains all of the
reagents from the system and then rinses the fluidics with
deionized water.

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Maintenance
Chapter 9 Special Protocols Menu

The [CLEAN NEEDLE] key is used to clean the needles used in


CLEAN
NEEDLE either of the Closed Modes (CS or SL) of operation. When this
key is pressed, the needle is forcefully rinsed with diluent.

EXTEND The [EXTEND AUTOCLEAN] key is used to initiate the Extended Auto-
AUTO-CLEAN Clean cycle, which is a longer version of the Auto-Clean cycle.
When the [EXTEND AUTOCLEAN] key is pressed, the screen displays
the message shown in Figure 9.17, Special Protocols: Extended
Auto-Clean Screen in the Monthly section within this chapter. The
following soft key labels are displayed:
START
CANCEL
These keys are used to [START] or [CANCEL] the Extended Auto-
Clean cycle.

MORE The [MORE] key is used to return to the first SPECIAL PROTOCOLS
screen.

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Special Protocols Menu Chapter 9

NOTES

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Chapter 9 Maintenance

Maintenance Log Set Up

The Maintenance Log is used to keep a record of the maintenance


procedures that have been performed on the instrument. It can also
be configured to notify the operator when a scheduled
maintenance procedure should be performed.

MAINTENANCE LOG Nov 20 1998 16:01


Ready Operator ID rcs
Sequence # 0711

SHEAR AIR APERTURES PUMP TUBING EXT


Date Time OpID VALVE FILTR SYNG WIC RBC ASPR WOC SL AUTO AUTO OTHER
10/09/98 08:30 sh X X X
Comments: Weekly Maintenance

10/16/98 08:32 jg X X X
Comments: Weekly Maintenance

10/23/98 08:33 td X X X X X X X
Comments: Weekly Maintenance

INTERVAL UPDATE PRINT & PRINT RETURN


SET UP LOG PURGE LOG

Figure 9.5: Maintenance Log Screen

MAINTEN The MAINTENANCE LOG screen is accessed from the SPECIAL


LOG PROTOCOLS screen by pressing the [MAINTEN LOG] key. When the
[MAINTEN LOG] key is pressed and scheduled maintenance is due, a
Bulletin Line on the MAINTENANCE LOG screen will display the
following message:
MAINTENANCE DUE: — followed by the name(s) of the
components(s) requiring maintenance
NOTE: The bulletin message will disappear when any key
is pressed.

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Maintenance
Maintenance Log Set Up Chapter 9

The log displays the following entry fields: <Date>, <Time>, <OpID>,
<SHEAR VALVE>, <AIR FILTR>, <SYNG>, <APERTURES> (<WIC> and
<RBC>), <PUMP TUBING> (<ASPR> and <WOC>), <SL>, <EXT AUTO>,
<AUTO>, <OTHER>, and a line for <Comments>. (Up to 70 characters
may be entered in the <Comments> line.) The log holds 40 entries,
but the screen displays only the 5 most current. Other entries can
be displayed by pressing the Page Up or Page Down keys on the
keyboard.

Each time an entry is made, the current date, time, and operator
ID are automatically entered in the log. When the UPDATE
MAINTENANCE LOG screen (illustrated in Figure 9.7, Update
Maintenance Log Screen) is displayed, the cursor is automatically
positioned in the <Op ID> entry field. If desired, the ID may be
edited. Entries are made by moving the cursor with the arrow keys
on the keyboard to the desired entry field and pressing the Enter
key on the keyboard. An “X” is displayed to indicate the completed
maintenance and the cursor advances to the next entry field.
NOTE: Entries can also be made by moving the cursor to
the desired location, typing an “X”, and pressing the Enter
key on the keyboard.

An incorrectly placed “X” can be deleted by moving the cursor to


it and pressing the Space Bar on the keyboard.
Comments may be entered in the <Comments> entry field of the
Maintenance Log if entries have been made in the other fields.
Comments and maintenance entries (Xs) can also be edited after
they have been made. However, once the [RETURN] key has been
pressed, the changes are saved and changes can no longer be
made.
A printout can be made at any time, but when the log is full all
entries must be deleted before new ones can be added. When the
log is full, a Bulletin Line will display the following message:
MAINTENANCE LOG IS FULL, NO MORE ENTRIES CAN BE
CREATED
The [PRINT & PURGE] key is used to print the log and delete all
entries.

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Maintenance
Chapter 9 Maintenance Log Set Up

Interval Set Up Procedure

INTERVAL SET UP Nov 09 1998 12:24


Ready Operator ID sh
Sequence # 0630

Specify a maintenance interval if you want the instrument


to prompt you when it is time to do the maintenance.

Enter the maintenance interval (in days) for each of the following:
(enter 0 for no interval)

SHEAR VALVE 7
AIR FILTERS 30
SYRINGES 30
WIC APERTURE 30
RBC APERTURE 90
ASPIRATION PUMP TUBING 90
WOC PUMP TUBING 30
SAMPLE LOADER TRAY AND RACKS 30
EXTENDED AUTO-CLEAN 30
AUTO-CLEAN 7

PRINT RETURN

Figure 9.6: Interval Set Up Screen

NOTE: Before the Interval Setup feature of the


Maintenance Log will function, an initial Maintenance
Log must be created as a reference for Interval
implementation. This log should be accessed, the
operator’s initials entered, and an X placed under every
procedure listed at the top of the log by placing the cursor
in the first field and pressing the Enter key on the
keyboard. The cursor will advance to the next field
automatically. By continuing to press the Enter key, the X’s
may be placed under each procedure. Once all the
procedures have been selected, the log has a reference
point for future notification of maintenance that is due.

1. From the MAIN MENU screen, press the [SPECIAL PROTOCOLS]


key followed by the [MAINTEN LOG] key.
2. Press the [INTERVAL SET UP] key to display the INTERVAL SET
UP screen.
3. Use the arrow keys on the keyboard to move the cursor to the
desired maintenance procedure.

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Maintenance
Maintenance Log Set Up Chapter 9

4. Type the desired interval in days, and press the Enter key on
the keyboard to save the entry and advance the cursor.
5. If desired, press [PRINT] to obtain a printout of the entered
intervals.
6. Press [RETURN] twice to return to the SPECIAL PROTOCOLS
screen.
7. Press [MAIN] to return to the MAIN MENU screen.

Update Maintenance Log Procedure

UPDATE MAINTENANCE LOG Nov 10 1998 12:31


Ready Operator ID sh
Sequence # 0630

SHEAR AIR APERTURES PUMPTUBING EXT


Date Time Op ID VALVE FILTR SYNG WIC RBC ASPR WOC SL AUTO AUTO
OTHER
11/10/98 08:30 sh X X X
Comments: Weekly Maintenance

11/10/98 08:32 sh X X X
Comments: Weekly Maintenance

11/10/98 08:33 sh X X X X X X X
Comments: Weekly Maintenance

11/10/98 10:30 sh
Comments:

RETURN

Figure 9.7: Update Maintenance Log Screen

After the maintenance procedure has been performed, access the


log as directed in this procedure.

1. From the MAIN MENU screen, press the [SPECIAL PROTOCOLS]


key followed by the [MAINTEN LOG] key.
2. Press the [UPDATE LOG] key. The cursor is positioned in the
<OPERATOR ID> entry field. (See the preceding figure.) If
necessary, edit the operator ID at this time.
3. Use the arrow keys on the keyboard to move the cursor to the
desired entry field.

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Maintenance
Chapter 9 Maintenance Log Set Up

4. Press the Enter key on the keyboard. An “X” will be displayed


to indicate the completed maintenance and the cursor will
advance to the next entry field.
NOTE: An incorrectly placed “X” can be deleted by
moving the cursor to it and pressing the Space Bar on the
keyboard.

5. Repeat steps 3 and 4 to make other entries.


6. When all entries have been made, use the arrow keys on the
keyboard to move the cursor to the <Comments> entry field.
7. Type any comments (up to 65 characters) and press the Enter
key on the keyboard.
NOTE: All current entries may be edited before the screen
is exited. When the [RETURN] key is pressed, all the entries
will be saved and cannot be changed.

8. Press [RETURN] twice to return to the main SPECIAL


PROTOCOLS screen.
9. Press [MAIN] to return to the MAIN MENU screen.

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Maintenance
Maintenance Log Set Up Chapter 9

NOTES

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9140320C — November 2000
Chapter 9 Maintenance

Daily Maintenance Procedures

NOTE: The Auto-Clean Cycle should be run after


performing any maintenance procedure.

Auto-Clean
The Auto-Clean Cycle is a fully automated cycle designed to clean
the Shear Valve, the WOC Mixing Chamber, the WOC Flow Cell,
the von Behrens WIC Transducer, the von Behrens RBC/PLT
Transducer, the HGB Flow Cell, the needle in the CS or SL system,
and all the associated fluidics. The forward and reverse action of
the peristaltic pumps is used during this cycle to gently scrub and
remove any fibrin or debris within the system. The Auto-Clean
Cycle takes approximately 11 minutes.

SPECIAL PROTOCOLS Nov 11 1998 12:10


Ready Operator ID CO3
Sequence # 4249

Hold a tube of Cell-Dyn Enzymatic Cleaner under the probe,


and press the START key

After the auto-clean cycle is completed


three or more background counts will be run.

This cleaning process takes about 11 minutes.

START CANCEL

Figure 9.8: Special Protocols: Auto-Clean Screen

Materials Required
1. CELL-DYN Enzymatic Cleaner (cleaner should be at room
temperature)
2. Clean test tube or container
3. Lint-free pads

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9140320E — September 2004
Maintenance
Daily Maintenance Procedures Chapter 9

4. Warm water
5. Appropriate personal protective equipment

Procedure
1. Select the Open Sampler Mode.
2. Carefully wipe the outside of the Open Sampler Aspiration
Probe and the bottom of the Wash Block with a pad
dampened with warm water and a few drops of CELL-DYN
Enzymatic Cleaner.
3. From the MAIN MENU screen, press the [SPECIAL PROTOCOLS]
key followed by the [MORE] key to access the Auto-Clean
function.
4. Press the [AUTO CLEAN] key. Instructions for performing the
procedure are given on the screen.
5. Dispense approximately 1.5 mL of Enzymatic Cleaner into a
clean container and hold the container under the Open
Sample Aspiration Probe.
6. Press the [START] key.
NOTE: Do not press the Touch Plate. The Auto-Clean
Cycle is only initiated by the [START] key.

7. Continue to hold the container under the probe until a beep


is heard. Remove the container and discard the remaining
Enzymatic Cleaner.
8. When the Auto-Clean cycle is completed, carefully wipe the
outside of the Open Sampler Aspiration Probe and the
bottom of the Wash Block with a lint-free pad dampened in
warm water to remove any traces of enzymatic cleaner.
9. If necessary, use a dry, lint-free pad to remove any water that
remains on the Probe or the Wash Block.
10. Press [MAIN] to return to the MAIN MENU screen. Check that
the background counts are acceptable before running
controls or patient samples. If the counts are unacceptable,
troubleshoot accordingly.

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Maintenance
Chapter 9 Daily Maintenance Procedures

Sample Loader Aspiration Needle


The Aspiration Needle on the Sample Loader version of the
CELL-DYN 3700 System should be cleaned regularly to remove
protein buildup or debris and to reduce the possibility of a
blockage.

NOTE: A convenient way to perform this procedure is to


add the tubes needed for the procedure to the end of the
last run of the day.

Materials Required
1. CELL-DYN® Enzymatic Cleaner
2. Diluent or deionized water
3. Three empty VACUTAINER® tubes
4. Appropriate personal protective equipment

Procedure
1. Aliquot approximately 2 mL of Enzymatic Cleaner into one
of the VACUTAINER® tubes.
2. Aliquot approximately 2 mL of fresh diluent each into the
other two VACUTAINER® tubes.
3. If necessary, from the Data Station RUN screen, press the
[CHANGE SAMPLER] key to select the Closed Mode.
4. Press the [SPECIMEN TYPE] key followed by the
[BACKGROUND] key.
5. Place the Enzymatic Cleaner tube followed by the two
diluent tubes in a Sample Loader end rack.
6. Position the rack in the Sample Loader tray and install the
Sample Loader Safety Cover.
CAUTION: The Sample Loader will not operate unless the
Safety Cover is in place.

7. Press the START key on the Sample Loader Control Panel to


initiate processing.
8. Audible beeps indicate that processing is completed.
9. Run at least five background counts before running controls
or patient samples. If the counts are unacceptable,
troubleshoot accordingly.

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9140320C — November 2000
Maintenance
Daily Maintenance Procedures Chapter 9

Closed Sampler Aspiration Needle


The Aspiration Needle on the Closed Sampler version of the
CELL-DYN 3700 System should be cleaned regularly to remove
protein buildup or debris and reduce the possibility of a
blockage.

Materials Required
1. CELL-DYN® Enzymatic Cleaner
2. Diluent or deionized water
3. Three empty VACUTAINER® tubes
4. Appropriate personal protective equipment

Procedure
1. Aliquot approximately 2 mL of Enzymatic Cleaner into one
of the VACUTAINER® tubes.
2. Aliquot approximately 2 mL of fresh diluent each into the
other two VACUTAINER® tubes.
3. If necessary, from the Data Station RUN screen, press the
[CHANGE SAMPLER] key to select the Closed Mode.
4. Press the [SPECIMEN TYPE] key followed by the [BACKGROUND]
key.
5. Run the Enzymatic Cleaner.
6. Run the diluent tubes.
7. Run at least five background counts before running controls
or patient samples. If the counts are unacceptable,
troubleshoot accordingly.

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Chapter 9 Maintenance

Weekly Maintenance Procedures

NOTE: The Auto-Clean Cycle described in Daily


Maintenance Procedures, Auto-Clean Cycle within this
chapter should be run after performing any maintenance
procedure.

Shear Valve

Rear Section
Center Section

Front Section

Tubing Loop

Mounting Guide
Retaining Screw
Rim Notch

Figure 9.9: Shear Valve

Regular cleaning of the Shear Valve ensures accurate and precise


performance. Any reagent or blood residue may cause the valve
to leak or function improperly. The Shear Valve Assembly is
depicted in the preceding figure.
The Shear Valve is made of a ceramic material and consists of
three separate sections — front, center, and rear. The rear and front
sections are connected to the CELL-DYN 3700 System by tubing
that should not be removed.
NOTE: The center section is not connected to the Analyzer
by tubing and must be handled carefully, as it will break if
it is dropped. Care should be taken to avoid chipping,
scratching, or otherwise damaging any of the sections.

Materials Required
1. Deionized water
2. Lint-free pads
3. Appropriate personal protective equipment

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9140320E — September 2004
Maintenance
Weekly Maintenance Procedures Chapter 9

Procedure
1. Remove the Left Front Cover to gain access to the Shear
Valve.
NOTE: It is necessary to also remove the Tower Cover on
the SL model to access the Shear Valve.

2. From the MAIN MENU screen, press the [SPECIAL PROTOCOLS]


key followed by the [CLEAN SHEAR VAL] key. This prepares
the Shear Valve for removal and puts the Analyzer into a
NOT READY state.
3. Turn the Shear Valve Retaining Screw counterclockwise until
it can be removed.
4. Grasp the entire valve assembly firmly and pull it forward with
a slight rocking motion until it is free of the Mounting Guide.
5. Rotate the center and front sections in the opposite direction
from the rear section to release any suction and free the rear
section.
NOTE: Be careful to keep a firm grip on the center section,
as it is not attached to the front or rear sections and it may
break or crack if dropped. Avoid crimping any of the
attached tubing in the front and rear ceramic sections.

6. Place the rear section with its attached tubes on a clean


lint-free pad in the Shear Valve compartment.
7. Rotate the center and front sections in opposite directions to
separate the sections.
8. Place the center section in a container of deionized water and
allow it to soak for the remainder of the cleaning procedure.
NOTE: Do not soak the center section in bleach as it may
damage the ceramic.

9. Place the front section with its attached tubes on a clean


lint-free pad in the Shear Valve compartment.
10. Clean the Mounting Guide with lint-free pad dampened with
deionized water to remove any blood or residue. Wipe the
guide dry.
11. Wipe the inner surfaces of the front and rear sections with a
clean lint-free pad dampened with deionized water. Use care
to avoid scratching any of the inner surfaces.
NOTE: Hold the sections by the edges to avoid getting
fingerprints on the inner surfaces.

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Maintenance
Chapter 9 Weekly Maintenance Procedures

12. Align the lock notch of the rear section with the back panel
of the Shear Valve Assembly. Carefully slide the section back
as far as it will go. Avoid crimping any of the attached tubing.
13. Remove the center section from the deionized water, and
wipe the surfaces with a lint-free pad dampened in deionized
water. Do not dry.
14. View each surface under reflective light to confirm that it is
clean, and free of lint and fingerprints.
15. Align the center section so that the Rim Notch in the outer
edge faces to the right.
CAUTION: Be certain the Rim Notch faces to the right.
(See Figure 9.9, Shear Valve for correct center section
orientation.) Erroneous results will be obtained if
specimens are analyzed when the center section is
installed backwards.

16. Carefully slide the center section onto the Mounting Guide
and push it back until it touches the rear section.
17. Align the lock notch of the front section with the Mounting
Guide. Carefully slide it back until it touches the center
section.
18. Firmly hold the three valve sections in place and replace the
Shear Valve Retaining Screw. Turn the screw clockwise until
it stops.
19. Press the [RESTORE SHEAR VAL] key. The valve automatically
rotates several times. The instrument is returned to the
READY state when the rotation is finished.
20. Visually inspect the Shear Valve to ensure that the Rim
Notch of the center Shear Valve section faces to the right.
(Refer to Figure 9.9, Shear Valve for correct center section
orientation.)
21. Replace the Left Front Cover.
22. Press the [MAIN] key to return to the RUN screen.
23. Run at least five background counts before running controls
or patient samples. If the counts are unacceptable,
troubleshoot accordingly as directed in Chapter 10:
Troubleshooting.

CELL-DYN® 3700 System Operator’s Manual 9-25


9140320C — November 2000
Maintenance
Weekly Maintenance Procedures Chapter 9

Sample Aspiration Peristaltic Pump Tubing


The tubing in the two Peristaltic Pumps needs to be replaced on a
regular basis to ensure proper fluid movement through the
instrument. The Sample Aspiration Pump Tubing requires more
frequent replacement than the larger WOC Transfer Peristaltic
Pump Tubing. However, the frequency of replacement depends
on instrument use in each laboratory. Abbott recommends
changing the Sample Aspiration Pump Tubing weekly and the
WOC Transfer Peristaltic Pump Tubing monthly. A Peristaltic
Pump is depicted in the following figure.

Pump Rollers
Metal Brackets

Collar

Tubing

Pump
Pump Shoe
Wheel
Figure 9.10: Sample Aspiration Peristaltic Pump

Materials Required
1. Sample Aspiration Peristaltic Pump Tubing.
NOTE: The Sample Aspiration Pump Tubing has a smaller
diameter and is identified by the orange collar on each
end.

2. Appropriate personal protective equipment

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Maintenance
Chapter 9 Weekly Maintenance Procedures

Procedure
1. From the SPECIAL PROTOCOLS screen, press the [DISABLE
ANALYZER] key.
2. Remove the Left and Right front covers to gain access to the
Peristaltic Pumps.
3. Locate the Sample Aspiration Pump to the left of the Shear
Valve.
4. Hold the Pump Shoe away from the pump wheel and remove
the tubing from under the pump wheel by lifting the collars
out of the metal brackets that hold them. Pull the tubing
completely out from under the pump wheel. (Refer to Figure
9.10)
5. Disconnect the tubing at the plastic connector.
6. Connect the new tubing to the plastic connector.
7. Place the collars on the ends of the pump tubing into the
metal brackets as shown in Figure 9.10. Hold the Pump Shoe
open and insert the tubing back under the pump rollers.
Make sure the tubing is positioned in the center of the
rollers. When the tubing is centered, release the Pump shoe.
8. Replace the Front Covers.
9. Press the [ENABLE ANALYZER] key.
10. Press the [MAIN] key to return to the MAIN MENU screen.
11. Run at least five background counts before running controls
or patient samples. If the background counts are
unacceptable, troubleshoot accordingly.

Sample Loader Tray, Racks, and Safety Cover


The Sample Loader Tray, Racks, and Safety Cover should be
cleaned on a regular basis. Blood spills in the tray or racks should
be cleaned up immediately to allow proper movement of the
racks. Weekly cleaning is recommended, but more frequent
cleaning may be indicated by the laboratory workload.

Materials Required
1. Container (large enough to hold a rack) filled with a mild
detergent solution made with warm (not hot) water
2. Clean, warm water for rinse
3. Lint-free pads
4. Appropriate personal protective equipment

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Maintenance
Weekly Maintenance Procedures Chapter 9

Procedure
1. Remove the racks from the Sample Loader tray.
2. Wash the racks in the detergent solution. Do not allow them
to soak in the solution, as the labels will come off.
NOTE: When cleaning the racks, do not use an automated
washing system that operates at elevated tempertures as this
may damage the racks.

3. Rinse the racks with warm water and dry thoroughly with
lint-free pads or towels.
4. Wipe the stainless steel tray area with a lint-free pad
moistened with water. Dry the tray with a lint-free pad or
towel.
5. Wipe the stainless steel plate behind the vent/aspirate and
mixing stations with a lint-free pad moistened with water.
Dry the plate with a lint-free pad.
6. Clean the mixing heads with a lint-free pad moistened with
water. Dry the heads with a lint-free pad.
7. Wash the Safety Cover with the detergent solution, rinse,
and dry it.

Extended Auto Clean


The Extended Auto Clean cycle should be run weekly when
routinely running reticulocytes. Directions for running Extended
Auto Clean, which takes approximately 2.5 hours to complete, are
included in the monthly maintenance section of this chapter.

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Chapter 9 Maintenance

Monthly Maintenance Procedures

NOTE: The Auto-Clean Cycle described in Daily


Maintenance Procedures, Auto-Clean within this chapter
should be run after performing any maintenance procedure.

Reagent Syringes
The Reagent Syringes need to be cleaned on a regular basis to prevent
reagent residue buildup, which may cause leakage or improper
functioning. Syringes should be cleaned one at a time to ensure that
each syringe is replaced in the correct position. Replace each syringe
after it is cleaned and then remove the next one to be cleaned. The
Syringe Assembly is depicted in Figure 9.11.
The 10-mL Syringe should be cleaned as required; the 0.5mL and
2.5 mL syringe should be cleaned monthly.

Syringe Assembly

WOC Metering
Syringe

WOC Sheath
Syringe

V-Block Holder

Pedestal Assembly
Flange

Figure 9.11: WOC Syringes and Syringe Assembly

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9140320E — September 2004
Maintenance
Monthly Maintenance Procedures Chapter 9

2.5-mL Syringe and 0.5-mL Syringe

Materials Required
1. A large container filled with approximately 500 mL of
deionized water
2. Lint-free pads (or other lint-free pads)
3. Deionized water
4. Small container of appropriate reagent to refill the clean
syringes
5. Appropriate personal protective equipment

Procedure
1. From the MAIN MENU screen, press the [SPECIAL PROTOCOLS]
key followed by the [DISABLE ANALYZER] key.
2. Remove the front covers to gain access to the Syringe Assembly.
3. Lift the syringe out of the snap-in bracket. Note the liquid level in
the syringe so that it can be refilled after cleaning to approximately
this same level. (For example, a piece of tape may be attached to
the syringe barrel to note the position of the plunger tip.)
4. Grasp the metal Luer Lock fitting at the tip of the syringe
that attaches it to the tubing. Carefully turn the syringe
clockwise to release it from the fitting. Use lint-free pads to
absorb excess reagent.
5. Dispense the reagent into a sink or an appropriate waste
container.
6. Aspirate deionized water into the syringe until it is full. Continue
to pull on the plunger until it is removed from the barrel.
NOTE: Do not push or pull on the plunger when the
syringe is dry, as it may damage the plunger. Avoid
touching the plunger because oil from the fingers may
cause it to move erratically.

7. Rinse the plunger and barrel thoroughly with deionized


water. Carefully reinsert the plunger into the wet barrel.
8. Refill the syringe with the appropriate reagent to the level noted
in step 3 above. Hold the syringe upright and tap the side gently
to dislodge any bubbles that may adhere to the tip of the plunger.
9. Carefully adjust the position of the plunger as necessary to
insert it into the pedestal assembly that moves it up and
down during the cycle.

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10. Insert the syringe tip into the Luer Lok® fitting and turn the
syringe counterclockwise until the fitting is finger-tight. Be
careful to not overtighten the fitting or crimp the associated
tubing.
11. Insert the syringe into the bracket and the end of the plunger
into its slot in the pedestal assembly. Position the horizontal
flange on the back of the syringe into the slot at the base of
the bracket.
12. When the syringe has been reinstalled, press the [ENABLE
ANALYZER] key.
13. Press the [MAIN] key to return to the MAIN MENU screen.
14. Run several background counts and observe the action of
each syringe during the cycle. The plunger should move
smoothly up and down and the syringe should not leak.
15. Replace the front covers after the operation of the syringes
has been verified.
16. Run at least five background counts before running controls
or patient samples. If the background counts are
unacceptable, troubleshoot accordingly.

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Maintenance
Monthly Maintenance Procedures Chapter 9

Analyzer Air Filters


The Left Side Panel of the Analyzer contains a set of Air Inlet
Filters that clean the air entering the Analyzer. These filters require
monthly removal and cleaning to maintain a constant, unrestricted
air flow. More frequent cleaning is required whenever the
instrument is located in a particularly dusty or warm area.

Air Inlet
Filters

Normally
Closed
Valves

Figure 9.12: Analyzer Left Side Panel

Materials Required
1. Running water
2. Lint-free pads
3. Small vacuum cleaner (optional)
4. Appropriate personal protective equipment

Procedure
1. Remove the Front Covers to gain access to the filter holders
on the Left Side Panel. (See the preceding figure.)
2. Grasp the upper filter and slide the holder forward to remove
it. The lower filter is removed the same way.

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3. Choose one of the following two options:


• Remove the filters from the frames and rinse with warm
water from the inside to the outside to remove the dust.
Blot each filter with lint-free pads or towels to dry the
filters before replacing them.
• Clean the filters by vacuuming them.
4. Insert the upper filter holder into its slot (metal frame side
toward the instrument). Slide it back into place until the
holder is flush with the Front Panel. Repeat this process to
install the lower filter holder.
5. Replace the Front Covers.

WOC Transfer Peristaltic Pump Tubing


The tubing in the two Peristaltic Pumps needs to be replaced on a
regular basis to ensure proper fluid movement through the
instrument. The Sample Aspiration Pump Tubing requires more
frequent replacement than the larger WOC Transfer Peristaltic
Pump Tubing. However, the frequency of replacement depends
on instrument use in each laboratory. Abbott recommends
changing the Sample Aspiration Pump Tubing weekly and the
WOC Transfer Peristaltic Pump Tubing monthly. A Peristaltic
Pump is depicted in the following figure.

Pump Rollers

Pump Tubing Metal Brackets

Collar Pump Shoe

Figure 9.13: WOC Transfer Peristaltic Pump

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Maintenance
Monthly Maintenance Procedures Chapter 9

Materials Required
1. WOC Transfer Peristaltic Pump Tubing.
NOTE: The WOC Transfer Pump Tubing has a larger
diameter than the Sample Aspiration Pump Tubing (orange
collar) and is identified by the clear collar on each end.

2. Appropriate personal protective equipment

Procedure
1. From the SPECIAL PROTOCOLS screen, press the [DISABLE
ANALYZER] key.
2. Remove the upper front cover to gain access to the Peristaltic
Pumps.
3. Locate the WOC Transfer Peristaltic Pump to the far left of
the Flow Panel.
4. Hold the Pump Shoe away from the pump wheel and remove
the tubing from under the pump wheel by lifting the collars
out of the metal brackets that hold them. Pull the tubing
completely out from under the pump wheel. (Refer to Figure
9.13)
5. Disconnect the tubing at the plastic connector.
6. Connect the new tubing to the plastic connector.
7. Place the collars on the ends of the pump tubing into the
metal brackets as shown in Figure 9.13. Hold the Pump Shoe
open and insert the tubing back under the pump rollers.
Make sure the tubing is positioned in the center of the
rollers. When the tubing is centered, release the Pump shoe.
8. Replace the Upper Front Cover.
9. Press the [ENABLE ANALYZER] key.
10. Press the [MAIN] key to return to the MAIN MENU screen.
11. Check that the background counts are acceptable before
running controls or patient samples. If the background
counts are unacceptable, troubleshoot accordingly.

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Extended Auto-Clean
The Extended Auto-Clean Cycle is a fully automated cycle
designed to clean the Shear Valve, the WOC Mixing Chamber,
the WOC Flow Cell, the von Behrens WIC Transducer, the von
Behrens RBC/PLT Transducer, the HGB Flow Cell, the needle in the
CS or SL version, and all the associated fluidics. The forward and
reverse action of the Peristaltic Pumps is used during this cycle to
gently scrub and remove any fibrin or debris within the system.
The Extended Auto-Clean cycle takes approximately 2.5 hours to
complete. During this time, the instrument is not available to
process samples or manipulate data. (When the process is
complete, the instrument is automatically put in the STANDBY
state.) The cycle may be canceled after 38 minutes by pressing the
[CANCEL] key, which is displayed at this time.
IMPORTANT: It is not possible to exit the SPECIAL PROTOCOLS
screen when the Extended Auto-Clean cycle is in progress. The
screen may be exited only after the [CANCEL] key (displayed after
38 minutes) is pressed or when the cycle is complete.

SPECIAL PROTOCOLS Nov 09 1998 12:25


Ready Operator ID sh
Sequence # 0630

Hold a tube of Cell-Dyn Enzymatic Cleaner under the probe


and press the START key

The Extended Auto-Clean process takes 2.5 hours to complete. During this time, the system is unavailable for processing
samples or manipulating data. When the Extended Auto-Clean process is complete, the instrument will go into STANDBY.

It is important to begin with a sufficient reagent supply and a half empty waste container in order to successfully complete the
Extended Auto-Clean process.

After 38 minutes a CANCEL key is displayed. Press this key to cancel the Extended Auto-Clean process and return to the
operating mode.

START CANCEL

Figure 9.14: Special Protocols: Extended Auto-Clean Screen

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Maintenance
Monthly Maintenance Procedures Chapter 9
Materials Required
1. CELL-DYN Enzymatic Cleaner (should be at room temperature)
2. Clean test tube or container
3. Lint-free pads
4. Warm water
5. Appropriate personal protective equipment

Procedure
1. Select the Open Sampler Mode.
2. Carefully wipe the outside of the Open Sample Aspiration
Probe and the bottom of the Wash Block with a lint-free pad
dampened with warm water and a few drops of CELL-DYN
Enzymatic Cleaner. Wipe any dried reagent or blood off the
bottom of the Wash Block.
3. Press the [SPECIAL PROTOCOLS] key followed by the [MORE]
key to access the Extended Auto-Clean function.
4. Press the [EXTEND AUTOCLEAN] key. Instructions for
performing the procedure are given on the screen.
5. Dispense approximately 1.5 mL of Enzymatic Cleaner into a
clean container and hold the container under the Open
Sample Aspiration Probe.
6. Press the [START] key.
NOTE: Do not press the Touch Plate. The Extended Auto-
Clean cycle is initiated only by the [START] key.
7. Continue to hold the container under the probe until a beep
is heard. Remove the container and discard the remaining
Enzymatic Cleaner.
NOTE: The complete procedure takes 2½ hours but may
be terminated after 38 minutes by pressing the [CANCEL]
key. If the [CANCEL] key is pressed, a rinse cycle is initiated
that prepares the instrument for sample processing.
Proceed to Step 8.
8. When the rinse cycle finishes, carefully wipe the outside of
the Open Sampler Aspiration Probe and the bottom of the
Wash Block with a lint-free pad dampened in warm water to
remove any traces of enzymatic cleaner.
9. If necessary, use a dry, lint-free pad to remove any water that
remains on the Probe or the Wash Block.
10. Press [MAIN] to return to the MAIN MENU screen.
NOTE: At the end of the 2½ hours, the instrument
automatically goes into the STANDBY state. Press the [RUN] key
to bring the Analyzer out of STANDBY and prepare it for
sample processing. Run at least five background counts before
running controls or patient samples. If the backgrounds
counts are unacceptable, troubleshoot accordingly.
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Maintenance
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As Required

NOTE: The Auto-Clean cycle described in Daily


Maintenance Procedures, Auto-Clean within this chapter
should be run after performing any maintenance
procedure.

10-mL Reagent Syringe


The 10 mL Reagent Syringe requires minimal maintenance. Cleaning
is required only if reagent residue builds up and interferes with the
performance of the syringe. The Syringe Assembly is depicted in the
Figure 9.11, WOC Syringes and Syringe Assembly.

Materials Required
1. A large container filled with approximately 500 mL of
deionized water
2. Lint-free pads
3. Deionized water
4. Small container of diluent to refill the clean syringe
5. Appropriate personal protective equipment

Procedure
1. From the MAIN MENU screen, press the [SPECIAL PROTOCOLS]
key followed by the [DISABLE ANALYZER] key.
2. Remove the front covers to gain access to the Syringe
Assembly.
3. Grasp the plastic Luer-Lok fitting at the tip of the syringe
that attaches it to the tubing. Carefully turn the luer nut
on the syringe counterclockwise to release it from the fitting.
Use lint-free pads to absorb excess reagent.
4. Grasp the Syringe barrel below the Luer-Lok with one hand.
With the other hand, grasp the syringe plunger below the
metal band. Pull straight out to remove the syringe from the
snap-in bracket.
5. Note the liquid level in the syringe so that it can be refilled after
cleaning to approximately this same level. (For example, a piece
of tape may be attached to the syringe barrel to note the
position of the plunger tip.)

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6. Dispense the diluent into a sink or an appropriate waste


container.
7. Immerse the tip of the syringe in a container of deionized
water.
8. Aspirate deionized water into the syringe until it is full, and
dispnse the water into a sink or an appropriate waste
container.
NOTE: Do not pull the plunger out of the barrel. Do not
push or pull on the plunger when the syringe is dry, as it
may damage the plunger. Avoid touching the plunger
because oil from the fingers may cause it to move erratically.

9. Repeat step 8 as necessary.


10. Refill the syringe with diluent to the level noted in step 5
above. Hold the syringe upright and tap the side gently to
dislodge any bubbles that may adhere to the tip of the
plunger.
11. Carefully adjust the position of the plunger as necessary to
insert it into the pedestal assembly which moves the plunger
up and down during operation.
12. Insert the syringe Luer-Lok® nut into the fitting and turn the
syringe clockwise until the fitting is finger-tight. Be careful
to not overtighten the fitting or crimp the associated tubing.
13. Place the end of the plunger into its slot in the pedestal
assembly. Position the horizontal flange on the back of the
syringe into the flange slot on the syringe bracket. Align one
rib of the syringe in the rib slot on the syringe bracket.
Carefully push and twist the syringe into the bracket until it
snaps into position.
14. When the syringe has been reinstalled, press the [ENABLE
ANALYZER] key. Press the [MAIN] key to return to the MAIN
MENU screen.
15. Run several background counts and observe the action of the
syringe during the cycle. The plunger should move smoothly
up and down and the syringe should not leak.
16. Replace the front covers after the operation of the syringe
has been verified.
17. Run at least five background counts before running controls
or patient samples. If the background counts are
unacceptable, troubleshoot accordingly. Refer to Chapter 10:
Troubleshooting.
18. Run Controls and confirm that results are within acceptable
limits. If results are outside acceptable limits, follow your
laboratory’s quality control protocol for out of range results.

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Aperture Plates
The WIC Aperture Plate and the RBC/PLT Aperture Plate are
automatically cleaned during the Auto-Clean cycle. (The WIC
Aperture Plate is also cleaned at the end of every count cycle by the
Aperture Cleaning Circuit.) However, it may also be necessary to
remove them occasionally for cleaning. Refer to the instrument
logbook to find the latest baseline count time(s) obtained from a
diluent sample with an acceptable background count. Use the
baseline count time(s) to determine the frequency of cleaning
needed.

NOTE: Both count times are displayed on the RUN screen.


The WIC count time is displayed below and to the right of
the BASO results. The RBC count time is displayed to the
right of the MPV result. The count times are also displayed
on the RAW DATA SUMMARY screen accessible from the
DIAGNOSTICS MENU screen.

The WIC Aperture Plate should be cleaned if the count time


differs from the baseline value by more than 0.3 seconds or if
there are frequent WIC CLOG messages. The WIC Aperture Plate is
located in the von Behrens WIC Transducer Assembly and is
identified by "WBC" etched on the plate.
The RBC/PLT Aperture Plate should be cleaned if the count time
differs from the baseline value by more than 0.4 seconds or if
there are frequent RBC CLOG messages. The RBC/PLT Aperture
Plate is located in the von Behrens RBC/PLT Transducer Assembly
and is identified by "R/P" etched on the plate.
NOTE: The apertures are different sizes, therefore, the
Aperture Plates are NOT interchangeable.

The following procedure is applicable to either aperture. A


Transducer Assembly is depicted in the following figure.

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Maintenance
As Required Chapter 9

Counting Chamber

Mixing Chamber

Aperture Plate

Release Lever
(Closed Position)

Figure 9.15: von Behrens Transducer Assembly

Materials Required
1. Cleaning solutions:
Either of the following solutions may be used to clean the
Aperture Plate. Because they will deteriorate over time, each
solution should be prepared fresh just before use.
a. Mix 20 drops of Enzymatic Cleaner and 20 mL of warm
water in a container that is large enough to hold the
Aperture Plate.
b. Make a 25% bleach solution (1.25% sodium
hypochlorite) by adding 5 mL of bleach to 15 mL of
deionized water in a container that is large enough to
hold the Aperture Plate.
2. Aperture brush from the Accessory Kit
3. Squirt bottle of deionized water
4. Lint-free pads
5. Sonic cleaner (optional)
6. Appropriate personal protective equipment

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Procedure
1. Remove the Front Covers to gain access to the von Behrens
WIC or RBC/PLT Transducer Assembly.
2. Confirm that the Analyzer is in the READY state.
3. From the MAIN MENU screen, press the [SPECIAL PROTOCOLS]
key followed by the [EMPTY XDUCERS] Key. This will drain the
liquid from both the Transducer Assemblies.
NOTE: DO NOT attempt to remove the Aperture Plates
without first emptying the Transducer Assemblies.

4. When the Empty Transducer cycle stops, place a lint-free


pad or gauze under the transducer to prevent liquid from
dripping onto the solenoids located directly below it.
5. Pull the red Release Lever located in front of the transducer out
and to the right to release the Aperture Plate. (See the following
figure.)

Counting Chamber

Mixing Chamber

Aperture Plate

Orientation Release Lever


Notch (Open Position)

Figure 9.16: Transducer Assembly and Aperture Plate

6. Pull the Aperture Plate straight out from between the


Transducer Chambers to remove it from the assembly. Note
the orientation of the plate, as it must be replaced correctly.
(See the preceding figure.)

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7. If necessary, clean any debris from the Aperture Plate by


rotating the aperture brush in the opening. (The opening is
located inside the red jewel embedded in center of the plate).
NOTE: DO NOT use anything but the aperture brush
provided in the Accessory Kit to clean the aperture. Using
other implements may damage the aperture.

8. Place the Aperture Plate into the container of freshly


prepared cleaning solution. Submerge the Aperture Plate
completely in the solution and rotate the aperture brush in
the opening to ensure the cleaning solution penetrates it
completely. Allow the plate to soak for five minutes.
NOTE: If desired, the container (with the Aperture Plate
and cleaning solution) may be placed in a sonic cleaner for
two to three minutes instead of cleaning the Aperture
Plate with a brush. DO NOT leave the Aperture Plate in the
sonic cleaner longer than three minutes as prolonged
cleaning may loosen the aperture jewel.

9. When the plate is clean, remove it from the cleaning solution


and thoroughly rinse it with a stream of deionized water.
10. Insert the plate between the transducer chambers with the
Orientation Notch on the bottom leading edge. Carefully
push the Aperture Plate into place. Be sure that it is
completely seated between the chambers.
11. Move the release lever back to the left to securely hold the
plate in place. (See Figure 9.15, von Behrens Transducer
Assembly.)
12. Press the [FILL XDUCERS] key to refill the Transducer
Assemblies and the associated tubing.
13. Replace the Upper and Lower Front Covers.
14. Press [MAIN] followed by [RUN] to return to the RUN screen.
15. Run at least five background counts before running controls
or patient samples. If the background counts are
unacceptable, troubleshoot accordingly.
16. When an acceptable background count has been obtained,
record the count time(s) on that diluent sample in the
instrument logbook. This is the baseline count time for the
instrument.
NOTE: The baseline value may only be obtained
immediately after the WIC or RBC/PLT Aperture Plate has
been cleaned.

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Hemoglobin Flow Cell Manual Cleaning


NOTE: This is not a routine cleaning/maintenance
procedure. It should only be performed if routine methods
fail or at the request of Abbott Diagnostics Customer Service.

Under normal circumstances, the Auto-Clean Cycle is sufficient


to ensure the cleanliness of the HGB Flow Cell. However, if the
Auto-Clean Cycle fails to adequately clean the Flow Cell, this
procedure may be used. The HGB Flow Cell, the von Behrens WIC
Transducer, and Solenoid 13 are depicted in the following figure.

Mixing Chamber WIC Transducer


Assembly

Counting Chamber

HGB Flow Cell


Assembly Solenoid 13

Figure 9.17: The von Behrens WIC Transducer, HGB Flow Cell, and
Solenoid 13

Materials Required
1. Cleaning Solution:
Make a 25% bleach solution (1.25% sodium hypochlorite)
by adding 5 mL of bleach to 15 mL of deionized water.
2. 15-mL syringe with a piece of tubing attached
3. Appropriate personal protective equipment

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Procedure
1. Remove the front covers to gain access to the von Behrens
WIC Transducer and HGB Flow Cell Assembly.
2. Be sure that the Analyzer is in the READY state.
3. Manually open Solenoid 13 to completely drain all the liquid
from the von Behrens WIC Transducer and HGB Flow Cell.
(If necessary, refer to the preceding figure to locate
Solenoid 13.)
4. Close Solenoid 13.
5. Press the [SPECIAL PROTOCOLS] key followed by the [DISABLE
ANALYZER] key to disable the Analyzer.
6. Disconnect the clear TYGON® tubing from the fitting on the
top right of the von Behrens WIC Transducer Mixing
Chamber. (See the preceding figure.)
7. Fill the syringe with the cleaning solution and connect it to
the fitting on the top of the von Behrens WIC Transducer
Mixing Chamber. Dispense the cleaning solution into the
transducer until it is approximately half full.
8. Remove the syringe and reconnect the TYGON® tubing.
9. Manually open Solenoid 13 and allow approximately half of
the bleach solution to drain into the HGB Flow Cell.
10. Manually close Solenoid 13 to hold the bleach solution in
the Flow Cell.
11. Allow the bleach solution to remain in the transducer and
Flow Cell for 5 minutes.
12. When the time has elapsed, manually open Solenoid 13 to
drain the bleach solution from the transducer and Flow Cell.
13. Press [ENABLE ANALYZER] followed by [MAIN] to return to the
MAIN MENU screen.
14. Rinse the bleach solution out of the system by running a
minimum of five background counts. Check the TYGON®
tubing on the top of the von Behrens WIC Transducer
Mixing Chamber during the cycles to be sure it is properly
attached and does not leak.
15. Verify that the background counts are acceptable before
running controls or patient specimens. If the background
counts are unacceptable, troubleshoot accordingly.
16. Replace the Front Covers.

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Unclogging the Open Sample Aspiration Probe

Aspiration Probe
Tubing Connection
Open Sample
Aspiration Probe

Figure 9.18: Open Sample Aspiration Probe

The Open Sample Aspiration Probe is thoroughly cleaned


whenever the Auto-Clean Cycle is performed. If a blockage is
suspected, it may be cleared as directed in the following procedure.

Materials Required
1. Wire stylet, gauge #23 (not provided)
2. Empty VACUTAINER tube
3. CELL-DYN Enzymatic cleaner
4. Appropriate personal protective equipment

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Procedure
WARNING: Potential Biohazard. The probe is sharp and
potentially contaminated with infectious materials. Avoid
any contact with the tip of the probe.

1. Disable the Analyzer.


2. Remove the tubing from the top of the Open Sample
Aspiration Probe as indicated in the preceding figure.
3. Carefully insert the stylet into the probe and push it down
through the probe until it extends from the end. If a clot has
been pushed out of the probe, remove it from the stylet.
4. Remove the stylet from the probe.
5. Reconnect the tubing to the top of the probe.
6. Perform an Auto-Clean Cycle. (If necessary, refer to the
directions given earlier within this chapter.)
7. When the Auto-Clean Cycle is complete, run several
background counts and a blood sample and check for
complete aspiration. (There should be a minimum of one
inch of blood on either side of the Shear Valve.)
8. If aspiration is not complete, call Abbott Diagnostics
Customer Service (at 1-877-4ABBOTT in the US).
9. Verify that the background counts are acceptable before
running controls or patient specimens. If the background
counts are unacceptable, troubleshoot accordingly.

Bar Code Reader Window


Materials Required
1. Applicator swabs (non-sterile)
2. Microscope lens tissues
3. Deionized water
4. Appropriate personal protective equipment

Procedure
1. From the MAIN MENU screen, press the [SPECIAL PROTOCOLS] key.
2. From the SPECIAL PROTOCOLS screen, press the [DISABLE
ANALYZER] key.
3. Turn OFF the Sample Loader.
NOTE: The ON/OFF toggle switch is located on the left
end panel of the Sample Loader unit.

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4. Remove all racks from the Sample Loader tray.


5. Wrap an applicator swab with lens tissue.
6. Moisten the tissue with deionized water.
7. Locate the front Bar Code Reader Window under the Sample
Loader Tower and wipe the glass window with a moistened swab.
8. Wipe the window dry with the clean swab that has also been
wrapped with lens tissue.
9. Visually inspect the window to be sure debris, smudges, and
blood have been removed.
10. Return the 10 racks to the Sample Loader Tray.
11. Turn the Sample Loader to the ON position.
12. Press the [ENABLE ANALYZER] key to bring the CELL-DYN
3700 System to the READY state. And resume normal Sample
Loader operation procedures.

Flushing the “Y” Fitting — Open and Closed Modes


This procedure may be used to remove buildup or fibrin, which
may have formed in the plastic “Y” fitting and tubing located
behind the Analyzer Status Indicator Panel.

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Maintenance
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Shear Valve
Inlet Tubing

"Y" Fitting

Solenoid 95

Solenoid 96
Closed Mode
Valve Fitting
TEFLON® Tubing
for Drainage

Container
for Drainage

Figure 9.19: Flow Panel Open/Closed Mode Tubing

Materials Required
1. 10-mL syringe filled with cleaning solution:
Make a 25% bleach solution (1.25% sodium
hypochlorite) by adding 5 mL of bleach to 15 mL of
deionized water.
2. Tubing, two sizes to be used as a temporary drain line:
• TEFLON, 12"–18", small diameter
• Silicon, 2"–12", same diameter as pinch valve tubing
3. Paper towels/gauze
4. Appropriate personal protective equipment

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Procedure
1. From the MAIN MENU screen, select in the following order:
[DIAGNOSTICS], [MORE], [SOLENOID OPERATION], then [STEP
SOLENOID].
2. Place absorbent paper towels/gauze below the probe area to
catch any potential spills.
3. Place a container underneath the Open Probe to recover the
flushing solution.
4. Disconnect the Shear Valve Inlet Tubing from the front
section of the Shear Valve.
5. Flush the Open Mode tubing.
a. On the keyboard, type 95. Press Enter. Solenoid 95 (Open
Mode) will open.
b. Inject the cleaning solution through the tubing and into
the container underneath the probe. A “push/pull”
motion may be used to facilitate cleaning action.
6. Flush the Closed Mode tubing.
a. Refill the syringe with the cleaning solution and
reconnect to the Shear Valve Inlet Tubing.
b. Disconnect the Closed Mode Aspiration Tubing from the
Closed Mode Valve Fitting. Attach a piece of TEFLON®
tubing to the tubing in the Closed Mode Valve. Place the
other end of the tubing into a container for drainage.
c. On the keyboard, press the Up arrow key. Solenoid 95
will close; Solenoid 96 (Closed Mode) will open.
d. Using the syringe, inject the cleaning solution through
the tubing and into the container. A “push/pull” motion
may be used to facilitate cleaning action.
7. Remove syringe and reattach the Shear Valve Inlet Tubing.
8. Remove the TEFLON® drainage tubing from the Closed
Mode Valve Fitting.
9. Reinstall the Closed Mode Aspiration Tubing to the tubing
going through the Closed Mode Valve — the tubing on the
valve’s right side.
10. From the screen, select [DIAGNOSTICS], then [INITIALIZATION].
11. After Initialization is complete, press [MAIN] to return to the
MAIN MENU screen.
12. Run five background counts. Check that the background
counts are acceptable before running controls or patient
samples. If the background counts are unacceptable,
troubleshoot accordingly.

CELL-DYN® 3700 System Operator’s Manual 9-49


9140320D — June 2003
Maintenance
As Required Chapter 9

NOTES

9-50 CELL-DYN® 3700 System Operator’s Manual


9140320D — June 2003
Maintenance
Chapter 9 Special Procedures

Special Procedures

Closed Sampler Tube Retainer Adjustment (CS System Only)


It is necessary to adjust the Tube Retainer on the CELL-DYN 3700CS
System to accommodate different sized VACUTAINER® tubes. The
Closed Sampler Module is depicted in the following figure.

Release Levers

Tube Retainer

Cap Piercer Well

Figure 9.20: Closed Sampler Module

Materials Required
1. An empty VACUTAINER® tube
2. Appropriate personal protective equipment

Procedure
1. Squeeze the Release Levers on the sides of the Tube Retainer
between the thumb and forefinger to loosen the Tube
Retainer, and slide the clamp up.
2. Insert the VACUTAINER® tube upside down into the Cap
Piercer Well.
3. Slide the clamp down to hold the tube snugly in place.
4. Release the Release Levers when the Tube Retainer has been
properly positioned.
5. Check the height adjustment with several VACUTAINER®
tubes to be certain that it is correct.

CELL-DYN® 3700 System Operator’s Manual 9-51


9140320D — June 2003
Maintenance
Special Procedures Chapter 9

Preparation for Inactivity or Shipping


The Prepare For Shipping Cycle must be run if the instrument will
not be used for two weeks or more. This cycle must also be run prior
to shipping the instrument or relocating it. Salt deposits and reagent
residue may clog the flow system if they are not removed prior to a
period of inactivity or shipment. In addition, the tubing should be
removed from all of the Normally Closed Valves. Leaving this tubing
in the valves while the instrument is inactive may cause it to crimp
permanently. The Normally Closed Valves on the Analyzer Flow Panel
are shown in the following figure.

Normally Closed Valves

Figure 9.21: Analyzer Flow Panel: Accessing Normally Closed Valves

9-52 CELL-DYN® 3700 System Operator’s Manual


9140320E — September 2004
Maintenance
Chapter 9 Special Procedures

Materials Required
1. Container with approximately 500 mL of deionized water.
2. If the instrument will be shipped, the following are also needed:
• Shear Valve Dummy Center Section (this is stored in the
disk storage container located on the Analyzer Flow Panel
to the right of the WOC Flow Cell Access Cover)
• Four plastic bags to hold the reagent inlet and waste
outlet tubes
3. Appropriate personal protective equipment

Procedure
1. From the MAIN MENU screen, press the [SPECIAL PROTOCOLS]
key followed by the [MORE] key followed by the [PREPARE
SHIPPING] key.
2. Place the reagent lines in the container of deionized water
and then press the [START] key. The flow system will be
automatically rinsed. (This process takes about 10 minutes.)
NOTE: The message CLEAN FOR SHIPPING IS IN
PROGRESS is displayed during the rinsing process.

3. When the process is complete, the message CLEAN FOR


SHIPPING HAS COMPLETED is displayed. Turn OFF the
power to the instrument.
4. Carefully remove the reagent inlet tubes from the Normally
Closed Valves under the reagent reservoirs located on the Left
Side Panel of the Analyzer. (If necessary, refer to Figure 9.12,
Analyzer Left Side Panel for the location of these Normally
Closed Valves.)
5. Carefully remove the tubing from the Normally Closed
Valves on the Analyzer Flow Panel. There are two Normally
Closed Valves located to the right of the Shear Valve (only the
lower one is present on the CS Model) and another located
above the lower Aperture Cleaning Circuit Interlock Switch.
(See the preceding figure for the location of these valves.)
NOTE: To gain access to the Normally Closed Valves located
by the Shear Valve, loosen one screw and remove the other
screw that holds the Status Indicator Panel in place and
rotate the panel upward.

6. Remove the Peristaltic Pump tubing from the Sample


Aspiration Pump and the WOC Transfer Peristaltic Pump.

CELL-DYN® 3700 System Operator’s Manual 9-53


9140320D — June 2003
Maintenance
Special Procedures Chapter 9

If the instrument is to be shipped, perform the following steps:


7. Obtain the Shear Valve Dummy Center Section from the disk
storage container.
8. Clean the Shear Valve as directed in Steps 3-8 in the
procedure given in the weekly maintenance section of this
chapter. Reassemble the Shear Valve using the Dummy
Center Section.
9. Wrap the ceramic center section carefully for protection and
place it in the Accessory Kit.
10. Disconnect the power cords and put them in the Accessory Kit.
11. Remove the reagent inlet and waste outlet tubes. Place each
tube in a protective plastic bag and put the bags in the
Accessory Kit.
WARNING: Potential Biohazard. Waste in the outlet tubes
may be infectious. Wear powder-free, disposable gloves and
follow established, good laboratory working practices when
handling this material.

Repackaging for Shipment


When the CELL-DYN 3700 System is to be shipped and the
original packaging is available, repackage the instrument as it
was originally shipped.

When the instrument is to be shipped and the original packaging is


unavailable, call Abbott Diagnostics Customer Service
(at 1-877-4ABBOTT in the US) for assistance with repackaging the
unit for shipment.

9-54 CELL-DYN® 3700 System Operator’s Manual


9140320F — April 2007
Chapter 10 Troubleshooting
Troubleshooting

Introduction

This chapter gives instructions for troubleshooting. The


CELL-DYN® 3700 System continuously monitors the status of the
system and displays pertinent information in the Status Box or on
the bulletin line. If a problem is detected, the Status Box displays
the message: FAULT: SEE DIAG or SEE SPECIAL, the bulletin
line displays a message, and the word FAULT on the Analyzer
status indicator panel is illuminated in red. A description of the
fault can be obtained by pressing the [FAULT REPORT] key on the
DIAGNOSTICS MENU screen.

The first section of this chapter discusses the DIAGNOSTICS MENU


soft keys. The remainder of the chapter is devoted to the
Troubleshooting Guide.

The Troubleshooting Guide is designed to assist the operator in


identifying and resolving instrument problems. Instructions are
also given for obtaining technical assistance from Abbott
Diagnostics Customer Service. The Guide includes
Troubleshooting Tips and Techniques, Troubleshooting
Procedures, and Instructions for Component Replacement. The last
section describes the Instrument Messages and Fault Conditions.
The tables in this section include instructions for corrective
action.

For information about interfering substances, refer to Chapter 5:


Operating Instructions, Subsection: Routine Operation, Sample
Collection and Handling, Interfering Substances.

CELL-DYN® 3700 System Operator’s Manual 10-1


9140320C — November 2000
Troubleshooting
Introduction Chapter 10

NOTES

10-2 CELL-DYN® 3700 System Operator’s Manual


9140320C — November 2000
Chapter 10 Troubleshooting

Diagnostics Menu

This section describes the soft keys displayed on the DIAGNOSTICS


MENU screens. These keys enable the operator or service
representative to obtain information and execute programs that
assist in troubleshooting and identify corrective actions.

Several keys listed are described as “For Service Use Only.” The
data these keys provide are meaningful only to trained Field
Service Representatives and are not useful to the operator. If
certain keys are pressed inadvertently, the system may have to be
initialized.

There are five primary screens in the DIAGNOSTICS MENU. For ease
of explanation, the keys are discussed screen by screen.

CELL-DYN® 3700 System Operator’s Manual 10-3


9140320C — November 2000
Troubleshooting
Diagnostics Menu Chapter 10

Diagnostics Menu Flowchart


DIAGNOSTICS MENU
Ready

FAULT EXECUTION CNT RATE CLEAR RAW DATA MORE PRINT MAIN
REPORT TIMES SUMMARY FAULTS SUMMARY

WOC RBC PLT WIC PRINT RETURN


CNT RATE CNT RATE CNT RATE CNT RATE
WOC RBC PLT WIC
CNT GRAPH CNT GRAPH CNT GRAPH CNT GRAPH

MOTOR SOLENOID PUMP DRAIN INITIAL- MORE MAIN


OPERATION OPERATION OPERATION ACCUMULAT IZATION

DIGITAL VOLTAGE GAIN MORE PRINT MAIN


CYCLE STEP DIAG- READINGS READINGS ADJUSTMNT
BANK SOLENOID NOSTICS

VACUUM PRESSURE INHIBIT VACUUM PRESSURE DIAG-


ON ON PUMPS TEST TEST NOSTICS
VACUUM PRESSURE ENABLE
OFF OFF PUMPS

MOTOR PWR HOME EXERCISE SHEAR VAL SHEAR VAL PRINT DIAG-
CHECKING MOTORS MOTOR TIME DISPENSE NOSTICS
SHEAR VAL
ASPIRATE

FINISH SELECT DIGITAL VOLTAGE GAIN MORE PRINT MAIN


SELECT READINGS READINGS ADJUSTMNT

VERIFY ENTER AUTO GAIN CURRENT SIGNAL PRINT DIAG-


GAINS SETTINGS ADJUSTMNT SETTINGS GENERATOR NOSTICS

MAM SPM WIM PRINT RETURN


TESTING TESTING TESTING

WOC RBC PLT WIC MORE PRINT MAIN


DATA DATA DATA DATA
RBC PLT WIC
HISTOGRAM HISTOGRAM HISTOGRAM

AUTO-SAMP BAR CODE BAR CODE SERIAL MORE PRINT MAIN


VERSION ALIGNMENT VERIFY TEST

WOC 1 WOC 2 CALC SCATTER SMOOTHING EXTENDED PRINT DIAG- STOP TRANSMIT DIAG-
DATA DATA CV GRAPHS ON/OFF WOC COUNT NOSTICS TRANSMISS MESSAGE NOSTICS
WOC 1 WOC 2
HISTOGRAM HISTOGRAM

10-4 CELL-DYN® 3700 System Operator’s Manual


9140320C — November 2000
Troubleshooting
Chapter 10 Diagnostics Menu

DIAGNOSTICS MENU Dec 20 1998 10:20


Ready Operator ID sh
Sequence # 0630

FAULT EXECUTION CNT RATE CLEAR RAW DATA MORE PRINT MAIN
REPORT TIMES SUMMARY FAULTS SUMMARY

Figure 10.1: First Diagnostics Menu Screen

DIAG- The first DIAGNOSTICS MENU screen (see the preceding figure) and
NOSTICS the following soft key labels are displayed when the [DIAGNOSTICS]
key is pressed:
FAULT REPORT
EXECUTION TIMES
CNT RATE SUMMARY
CLEAR FAULTS
RAW DATA SUMMARY
MORE
PRINT
MAIN

CELL-DYN® 3700 System Operator’s Manual 10-5


9140320C — November 2000
Troubleshooting
Diagnostics Menu Chapter 10

When the [FAULT REPORT] key is pressed, information regarding


FAULT
REPORT the pending fault is displayed on the screen. The screen displays
the words Operator correctable fault report: (see the
following figure) or Fatal fault report: (see Figure 10.3, Fatal
Fault Report Screen) and any additional information available. If
there is no fault, the screen displays the words No fault pending.
(See Figure 10.4, Fault Report — No Fault Pending Screen.)

DIAGNOSTICS MENU Dec 20 1998 12:28


Detergent empty Operator ID 732
Sequence # 2715

Operator correctable fault report :

Detergent empty

Detergent Empty

FAULT EXECUTION CNT RATE CLEAR RAW DATA MORE PRINT MAIN
REPORT TIMES SUMMARY FAULTS SUMMARY

Figure 10.2: Operator Correctable Fault Report Screen

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9140320C — November 2000
Troubleshooting
Chapter 10 Diagnostics Menu

DIAGNOSTICS MENU Dec 20 1998 12:20


Fault: See DIAG Operator ID 732
Sequence # 2713

Fatal fault report :

RBC diluent syringe overpressure

RBC diluent syringe overpressure

FAULT EXECUTION CNT RATE CLEAR RAW DATA MORE PRINT MAIN
REPORT TIMES SUMMARY FAULTS SUMMARY

Figure 10.3: Fatal Fault Report Screen

DIAGNOSTICS MENU Dec 20 1998 15:58


Ready Operator ID maa
Sequence # 1917

No fault pending

FAULT EXECUTION CNT RATE CLEAR RAW DATA MORE PRINT MAIN
REPORT TIMES SUMMARY FAULTS SUMMARY

Figure 10.4: Fault Report — No Fault Pending Screen

CELL-DYN® 3700 System Operator’s Manual 10-7


9140320C — November 2000
Troubleshooting
Diagnostics Menu Chapter 10

Operator correctable faults (for example, Waste Full, Diluent


Empty) can be cleared by pressing the [CLEAR FAULTS] key after
taking the appropriate corrective action. After the corrective
action has been taken for a fatal fault, the system must be
initialized.
EXECUTION This key is for service use only.
TIMES

DIAGNOSTICS MENU Dec 20 1998 12:29


Ready Operator ID 732
Sequence # 2715

WOC RBC PLT WIC PRINT RETURN


CNT RATE CNT RATE CNT RATE CNT RATE

Figure 10.5: Count Rate Summary Screen

CNT RATE When the [CNT RATE SUMMARY] key is pressed, the following soft
SUMMARY key labels (see the preceding figure) are displayed:
WOC CNT RATE or
WOC CNT GRAPH*

RBC CNT RATE or


RBC CNT GRAPH*
PLT CNT RATE or
PLT CNT GRAPH*
WIC CNT RATE or
WIC CNT GRAPH*
PRINT
RETURN
* These key labels alternate between the two selections when the
soft key is pressed.

10-8 CELL-DYN® 3700 System Operator’s Manual


9140320C — November 2000
Troubleshooting
Chapter 10 Diagnostics Menu

NOTE: The count rate and graphical data is available for


the previously run specimen only.

DIAGNOSTICS MENU Dec 20 1998 12:30


Ready Operator ID 732
Sequence # 2716

WOC : TOTAL COUNT: 5934


TIME: 0.50 1.05 1.55 2.07 2.57 3.08 3.62 4.12
COUNT: 361 808 1183 1576 1989 2359 2799 3225
RATE: 714.85 827.78 742.57 755.77 826.00 725.49 822.43 843.56
TIME: 4.63 5.14 5.67 6.21 6.73 7.24 7.50
COUNT: 3666 4074 4500 4924 5342 5743 5934
RATE: 864.71 800.00 811.43 777.98 803.85 794.06 720.75

WOC RBC PLT WIC PRINT RETURN


CNT GRAPH CNT RATE CNT RATE CNT RATE

Figure 10.6: WOC Count Rate Data (Tabular Format)


Each key displays kinetic data for the selected parameter from the
last cycle run. When each key is pressed, the count rate data is
displayed (see the preceding figure) and the key label changes to
[CNT GRAPH] for that parameter.

Count rate data from the last cycle is displayed in a tabular format.
The total count, time segments, and rate per second are displayed
for multiple data points from that cycle. (See the preceding
figure.) When the [CNT GRAPH] key for a particular parameter is
pressed, the rate-per-second data is displayed as a graph. (See the
following figure.) The kinetic data and graph are useful when
troubleshooting problems related to these parameters.

CELL-DYN® 3700 System Operator’s Manual 10-9


9140320C — November 2000
Troubleshooting
Diagnostics Menu Chapter 10

DIAGNOSTICS MENU Dec 20 1998 12:29


Ready Operator ID 732
Sequence # 2716

864.7

756.6

648.5

540.4

432.4

324.3

216.2

108.1

0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5

WOC CNT GRAPH

WOC RBC PLT WIC PRINT RETURN


CNT RATE CNT RATE CNT RATE CNT RATE

Figure 10.7: WOC Count Rate Graph

CLEAR When the [CLEAR FAULTS] key is pressed, the Analyzer returns to
FAULTS the Ready state if the corrective action taken resolved the
problem. If the corrective action did not correct the problem, the
fault status does not change.

NOTE: Only operator correctable faults can be cleared


with the [CLEAR FAULTS] key.

10-10 CELL-DYN® 3700 System Operator’s Manual


9140320C — November 2000
Troubleshooting
Chapter 10 Diagnostics Menu

DIAGNOSTICS MENU Dec 20 1998 12:33


Ready Operator ID 757
Sequence # 3143

List Mode WOC: 4350 RBC: 23598 PLT: 2682 WIC: 2956
Raw Count WOC: 4206 RBC: 31166 PLT: 2741 WIC: 3038 WIC Bubble: 94

RBC Times Upper: 3.53 Count: 6.23 Avg: 6.22 Timeout: 6.41

WIC Times Upper: 1.53 Count: 4.69 Avg: 4.69 Timeout: 4.89

HGB Sample 1: 1218 2: 1218 3: 1219 4: 1219 5: 1219


HGB Ref 2255 2254 2255 2255 2258

WOC Alg % Tot : 98.6%


RBC Alg RER : 33.9% Lo thr: 40 CTRUE : 342.4
PLT Alg Adj cnt: 2728 Lo thr: 8 Hi thr: 219

FAULT EXECUTION CNT RATE CLEAR RAW DATA MORE PRINT MAIN
REPORT TIMES SUMMARY FAULTS SUMMARY

Figure 10.8: Raw Data Summary Screen

RAW DATA When the [RAW DATA SUMMARY] key is pressed, detailed
SUMMARY information pertaining to the last cycle run is displayed. An
example of the RAW DATA SUMMARY screen is shown in the
preceding figure. The most useful information for the operator,
the metering times and the HGB Reference and Sample readings, is
highlighted on the screen shown in the preceding figure.

The information on metering times may be used to assist in


troubleshooting chronic Clog or Flow Error messages. The HGB
Reference and Sample readings may be used to assist in
troubleshooting erratic or imprecise HGB results.

MORE When the [MORE] key is pressed, the second DIAGNOSTICS MENU
screen is displayed. The [MORE] keys on the remaining screens to
be discussed always display the next DIAGNOSTICS MENU screen.
Consequently, they are discussed last in each section.

PRINT When the [PRINT] key is pressed, a Diagnostic Report is printed.


This report contains information pertinent to the data displayed
on the screen at the time the key is pressed. If no data is displayed
on the screen, the report prints the current fault status.

CELL-DYN® 3700 System Operator’s Manual 10-11


9140320C — November 2000
Troubleshooting
Diagnostics Menu Chapter 10

The [PRINT] key functions in this way on each screen. Therefore, it


will not be discussed again in this section.

MAIN The [MAIN] key is used to return to the MAIN MENU screen. The
[MAIN] key appears on each primary DIAGNOSTICS MENU screen and
works the same way on each screen. Consequently, it will not be
discussed again in this section.

DIAGNOSTICS MENU Dec 20 1998 10:20


Ready Operator ID sh
Sequence # 0630

MOTOR SOLENOID PUMP DRAIN INITIAL- MORE MAIN


OPERATION OPERATION OPERATION ACCUMULAT IZATION

Figure 10.9: Second Diagnostics Menu Screen

MORE When the [MORE] key on the first DIAGNOSTICS MENU screen is
pressed, the second DIAGNOSTICS MENU screen (see the preceding
figure) and the following soft key labels are displayed:

MOTOR OPERATION
SOLENOID OPERATION
PUMP OPERATION
DRAIN ACCUMULAT
INITIALIZATION
MORE
MAIN

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Troubleshooting
Chapter 10 Diagnostics Menu

This key is for service use only. The system must be initialized
MOTOR
OPERATION after this key is pressed.

SOLENOID This key is for service use only. The system must be initialized
OPERATION after this key is pressed.

DIAGNOSTICS MENU Dec 20 1998 12:34


Not Ready: See DIAG Operator ID 757
Sequence # 3143

VACUUM PRESSURE VACUUM PRESSURE DIAG-


ON ON TEST TEST NOSTICS

Figure 10.10: Pump Operation Screen

PUMP When the [PUMP OPERATION] key is pressed, the following soft key
OPERATION labels (see the preceding figure) are displayed:
VACUUM ON or
VACUUM OFF (The key label alternates between these two
selections.)
PRESSURE ON or
PRESSURE OFF (The key label alternates between these two
selections.)
INHIBIT PUMPS*
VACUUM TEST
PRESSURE TEST
DIAGNOSTICS
* This key is displayed after either key listed above it is pressed.

CELL-DYN® 3700 System Operator’s Manual 10-13


9140320C — November 2000
Troubleshooting
Diagnostics Menu Chapter 10

DIAGNOSTICS MENU Dec 20 1998 12:36


Not Ready: See DIAG Operator ID 732
Sequence # 2716

Vacuum is on

VACUUM PRESSURE INHIBIT VACUUM PRESSURE DIAG-


OFF ON PUMPS TEST TEST NOSTICS

Figure 10.11: Pump Operation Screen — Vacuum ON

VACUUM When the [VACUUM ON] key is pressed, the key label changes to
ON [VACUUM OFF], the vacuum pump is turned ON, and the screen
VACUUM
OFF
displays the message: Vacuum is on. (See the preceding figure.)
Press the [VACUUM OFF] key to turn the pump OFF.
NOTE: The pump is automatically turned OFF and control
of the pump is returned to the instrument when the screen
is exited.
This key is useful for troubleshooting vacuum problems. If the
pump does not turn ON when the key is pressed, the vacuum
pump may be the cause of the vacuum problem.
NOTE: The system must be initialized after this key is
pressed.

PRESSURE When the [PRESSURE ON] key is pressed, the key label changes to
ON [PRESSURE OFF], the pressure pump is turned ON, and the screen
PRESSURE
OFF
displays the message: Pressure is on. Press the [PRESSURE
OFF] key to turn the pump OFF.
NOTE: The pump is automatically turned OFF and control
of the pump is returned to the instrument when this
screen is exited.

10-14 CELL-DYN® 3700 System Operator’s Manual


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Troubleshooting
Chapter 10 Diagnostics Menu

This key is useful for troubleshooting pressure problems. If the


pump does not turn ON when the key is pressed, the pressure
pump may be the cause of the pressure problem.
NOTE: The system must be initialized after this key is
pressed.

DIAGNOSTICS MENU Dec 20 1998 12:36


Not Ready: See DIAG Operator ID 757
Sequence # 3143

Pressure and vacuum are inhibited

VACUUM PRESSURE ENABLE VACUUM PRESSURE DIAG-


OFF OFF PUMPS TEST TEST NOSTICS

Figure 10.12: Inhibit Pumps Screen

INHIBIT When the [INHIBIT PUMPS] key is pressed, the key label changes to
PUMPS [ENABLE PUMPS], operation of the pumps is inhibited (no vacuum
ENABLE
PUMPS
and pressure are produced), and the screen displays the message:
Pressure and vacuum are inhibited. (See the preceding
figure.) Press the [ENABLE PUMPS] key to enable pump operation.

NOTE: The pumps are automatically enabled and control of


them is returned to the instrument when this screen is exited.

This key is useful when performing maintenance or


troubleshooting procedures that require a vacuum or pressure
line to be removed.
NOTE: The system must be initialized after this key is
pressed.

CELL-DYN® 3700 System Operator’s Manual 10-15


9140320C — November 2000
Troubleshooting
Diagnostics Menu Chapter 10

DIAGNOSTICS MENU Dec 20 1998 12:39


Vacuum Recovery Time Test Operator ID 732
Sequence # 2716

Time elapsed : 3.3

Figure 10.13: Vacuum Test Screen

VACUUM When the [VACUUM TEST] key is pressed, the system releases the
TEST vacuum into the atmosphere and then determines the amount of
time required for it to return to the correct level. The key labels
disappear and the incrementing time is displayed on the screen.
(See the preceding figure.) When the test is complete, the time
stops incrementing and the key labels are displayed.
A vacuum recovery time greater than 5 seconds may indicate a
vacuum problem.
NOTE: The system must be initialized after this key is
pressed.

PRESSURE When the [PRESSURE TEST] key is pressed, the system releases the
TEST pressure into the atmosphere and then monitors the amount of
time required for it to return to the correct level. The key labels
disappear and the incrementing time is displayed on the screen.
When the test is complete, the time stops incrementing and the
key labels are displayed.
A pressure recovery time greater than 4 seconds may indicate a
pressure problem.
NOTE: The system must be initialized after this key is
pressed.

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9140320C — November 2000
Troubleshooting
Chapter 10 Diagnostics Menu

DIAGNOSTICS MENU Dec 20 1998 12:41


Draining accumulator Operator ID 732
Sequence # 2716

After draining the accumulators, press the INITIALIZATION key, prime,


run 5 Background Counts and confirm that the background results are
acceptable before running samples.

MOTOR SOLENOID PUMP DRAIN INITIAL- MORE MAIN


OPERATION OPERATION OPERATION ACCUMULAT IZATION

Figure 10.14: Drain Accumulators Screen

DRAIN When the [DRAIN ACCUMULAT] key is pressed, the internal vacuum
ACCUMULAT accumulators are drained of accumulated fluid. This key is used to
correct the Vacuum Accumulator Wet fault. (See the preceding
figure.)
When the process is completed, the system must be initialized
and primed. A prime cycle and background are automatically run
whenever the [RUN] key is pressed after the system is initialized.
Run an additional five background counts.
INITIAL- When the [INITIALIZATION] key is pressed, the Analyzer is
IZATION initialized. This is necessary when a fatal fault has occurred.
When the Analyzer is initialized, a prime cycle must be run.
NOTE: A prime cycle and background are automatically
run whenever the [RUN] key is pressed after the system is
initialized.

CELL-DYN® 3700 System Operator’s Manual 10-17


9140320C — November 2000
Troubleshooting
Diagnostics Menu Chapter 10

DIAGNOSTICS MENU Dec 20 1998 10:21


Ready Operator ID sh
Sequence # 0630

DIGITAL VOLTAGE GAIN MORE PRINT MAIN


READINGS READINGS ADJUSTMNT

Figure 10.15: Third Diagnostics Menu Screen

MORE When the [MORE] key is pressed, the third DIAGNOSTICS MENU
screen (see the preceding figure) and the following soft key labels
are displayed:

DIGITAL READINGS
VOLTAGE READINGS
GAIN ADJUSTMNT
MORE
PRINT
MAIN
DIGITAL This key is for service use only.
READINGS

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Troubleshooting
Chapter 10 Diagnostics Menu

DIAGNOSTICS MENU Dec 20 1998 12:40


Ready Operator ID 757
Sequence # 3143
Arrow keys to move around, SELECT key to select, FINISH SELECT key to go

DCM: slf-tst f/DAC:0.00 99mv refrence:0.08 15v/2 pwr sp :7.49 5v pwr sp :5.14
slf-test ramp:9.99 9.901v refrnc:9.86 -15v/2 pwr sp:-7.55
SPM: WOC threshold:0.85 SPM tst f/DAC:0.00 WOC ch 1 peak:0.00 RBC peak :0.00
RBC threshold:0.57 5v supply :5.12 WOC ch 2 peak:0.00 RBC intgrl:0.00
PLT L thrshld:0.53 10v refrence :9.97 WOC ch 3 peak:0.00 PLT peak :0.04
PLT H thrshld:9.97 -10v refrence:-10.0WOC ch 4 peak:0.00
MAM: ch 1 offset :0.20 ch 5 offset :-2.06electrode v/2:0.41 laser ref :0.00
ch 2 offset :0.97 ch 6 offset :-3.00apt crrnt set:-0.05
ch 3 offset :0.64 ch 3-Vdyn/100:6.14 tstpuls H set:-0.05
ch 4 offset :0.27 ch 4-Vdyn/100:5.65 tstpuls L set:-0.00
VPM: press 1 psi :12.0 press 3 psi :4.88 vac 1 in. Hg :11.8 pos rf prs:5.00
press 2 psi :9.01 vac 2 in. Hg :11.7 pos rf prs:-5.07
FCM: HGB output :5.53
WIC: WIC offset v :-3.26WIC H thrshld:7.30 WIC apt cr st:0.00 WIC peak :0.00
WIC elctd v/2:0.66 WIC L thrshld:1.54 WIC test puls:0.00

FINISH SELECT DIGITAL VOLTAGE GAIN MORE PRINT MAIN


SELECT READINGS READINGS ADJUSTMNT

Figure 10.16: Voltage Readings Screen

VOLTAGE When the [VOLTAGE READINGS] key is pressed, the voltage and
READINGS vacuum/pressure value from a test point, measured at the moment
when the key was pressed, is displayed. (See the preceding figure.)
The following additional soft key labels are displayed:

FINISH SELECT*
SELECT*
*These two keys are for service use only.

The data provided by the VOLTAGE READINGS screen can be useful


in determining if a problem is caused by a hardware malfunction.

GAIN This key is for service use only. The system may have to be
ADJUSTMNT initialized after this key is pressed.

CELL-DYN® 3700 System Operator’s Manual 10-19


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DIAGNOSTICS MENU Dec 20 1998 10:21


Ready Operator ID sh
Sequence # 0630

WOC RBC PLT WIC MORE PRINT MAIN


DATA DATA DATA DATA

Figure 10.17: Fourth Diagnostics Menu Screen

MORE When the [MORE] key is pressed, the fourth DIAGNOSTICS MENU
screen (see the preceding figure) and the following soft key labels
are displayed:

WOC DATA
RBC DATA
PLT DATA
WIC DATA
MORE
PRINT
MAIN
These keys are for service use only.

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DIAGNOSTICS MENU Dec 20 1998 12:49


Ready Operator ID C03
Sequence # 3122

AUTO-SAMP BAR CODE BAR CODE SERIAL MORE PRINT MAIN


VERSION ALIGNMENT VERIFY TEST

Figure 10.18: Fifth Diagnostics Menu Screen (CELL-DYN 3700SL System)

MORE When the [MORE] key is pressed, the fifth and last DIAGNOSTICS
MENU screen (see the preceding figure) and the following soft key
labels are displayed:

AUTO SAMP VERSION*


BAR CODE ALIGNMENT*
BAR CODE VERIFY*
SERIAL TEST
MORE
PRINT
MAIN
*These keys are displayed on the CELL-DYN 3700SL System only.

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DIAGNOSTICS MENU Dec 20 1998 12:50


Ready Operator ID C03
Sequence # 3122

Auto-Sampler Software : X:VER X.XX XX-XX-XX

AUTO-SAMP BAR CODE BAR CODE SERIAL MORE PRINT MAIN


VERSION ALIGNMENT VERIFY TEST

Figure 10.19: Auto-Sampler Version Screen

AUTO-SAMP This key is used to display the software version currently installed
VERSION in the Sample Loader. The Sample Loader must be ON before the
key is pressed. When the [AUTO-SAMP VERSION] key is pressed, the
screen displays the following message (see the preceding figure):

Auto-Sampler Software: [followed by the version


information]

NOTE: This key is displayed on the CELL-DYN 3700SL


System only.

BAR CODE This key is for service use only and is displayed on the CELL-DYN
ALIGNMENT 3700SL System only.

BAR CODE This key is for service use only and is displayed on the CELL-DYN
VERIFY 3700SL System only.

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DIAGNOSTICS MENU Dec 20 1998 12:51


Ready Operator ID C03
Sequence # 3122

Serial Interface Test


1. See Interface Specification.
2. If transmission in progress, press “STOP TRANSMISS” key first
3. Attach Loop-back connector to the serial interface
connector on back of the Data Station.
4. Press the “TRANSMIT MESSAGE” key to start the test.

STOP TRANSMIT DIAG-


TRANSMISS MESSAGE NOSTICS

Figure 10.20: Serial Test Screen

SERIAL The [SERIAL TEST] key is used to test the functionality of the RS232
TEST port (referred to as the “serial interface connector”) at the rear of
the Data Station. This test is designed to assist in troubleshooting
problems related to interfacing with a Laboratory Information
System (LIS). The loop-back connector must be connected to the
Data Station RS232 port before performing the test.

NOTE: If the laboratory does not have an LIS, the loop-


back connector may remain connected to the RS232 port
for convenience, as it does not interfere with routine
operation. If an LIS is usually connected, the loop-back
connector should be stored near the instrument when the
connector is not in use.

When the [SERIAL TEST] key is pressed, the following soft key
labels (see the preceding figure) are displayed:
STOP TRANSMISS
TRANSMIT MESSAGE
DIAGNOSTICS
The DIAGNOSTICS MENU screen for Serial Test displays the
following message:

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Serial Interface Test


1. See Interface Specification.
2. If transmission in progress, press “STOP
TRANSMISS” key first.
3. Attach Loop-back connector to the serial
interface connector on back of the Data
Station.
4. Press the “TRANSMIT MESSAGE” key to start the
test.

STOP The [STOP TRANSMISS] key is used to abort any transmission that is
TRANSMISS in progress to an LIS.

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DIAGNOSTICS MENU Dec 20 1998 12:52


Ready Operator ID C03
Sequence # 3122

Message sent : CELL-DYN serial interface test.


Message received :

STOP TRANSMIT DIAG-


TRANSMISS MESSAGE NOSTICS

Figure 10.21: Serial Test Transmit Message Screen Transmit Message

TRANSMIT When the [TRANSMIT MESSAGE] key is pressed, the message:


MESSAGE CELL-DYN serial interface test is transmitted from the
Data Station to the RS232 port, through the loop-back connector
and back to the Data Station. The DIAGNOSTICS MENU screen then
displays the message (see the preceding figure):
Message sent: CELL-DYN serial interface test
If the test is successful, the screen displays the message:
Message received: CELL-DYN serial interface test
This message indicates that the Data Station is communicating
properly. If the test is not successful, no message will be displayed.

DIAG- The [DIAGNOSTICS] key is used to return to the previous


NOSTICS DIAGNOSTICS MENU screen.

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NOTES

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Chapter 10 Troubleshooting

Troubleshooting Guide

Overview
Good troubleshooting skills are learned by using a logical, step-
by-step approach to problem solving. The first step in the process
is understanding normal instrument operation and preventive
maintenance. A good working knowledge of the instrument is
essential for identifying and resolving operational problems.

Logical troubleshooting may be divided into three steps:

1. Problem Identification
2. Problem Isolation
3. Corrective Action

Step 1, Problem Identification, involves not only identifying what


is wrong but also noting what is right. The investigator should
identify the problem area and eliminate areas that are working
correctly. Once this is done, the troubleshooting process moves
quickly to the next step.

Step 2, Problem Isolation, further classifies the problem.


Instrument problems are generally divided into three categories:
Measurement — related to sample analysis
Software — computer program related
Hardware — component related
Measurement problems are generally operator correctable. This
category is further subdivided into problems related to sample
handling, maintenance, or calibration. Typically, software and
hardware problems are corrected by an authorized service
representative.

Step 3, Corrective Action, involves taking appropriate action to


correct the problem. If the operator can correct the problem, with
or without technical assistance, normal operation can quickly
resume.
This Troubleshooting Guide is designed to enhance the
troubleshooting process by providing information to assist in
problem identification, isolation, and corrective action.

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Troubleshooting Tips and Techniques


Effective troubleshooting is possible only when the problem is
clearly recognized and the probable cause is isolated. This is always
facilitated by obtaining sufficient information and data pertaining to
the specific problem. Carefully observe the situation. Document the
steps that have been taken and record all results.
This Troubleshooting Guide is designed to guide the operator
through a logical series of steps to obtain information regarding
the nature of the problem. If it is necessary to call for technical
assistance, this information should be made available to the
Customer Support Specialist.
The procedures referred to throughout this section are described
in this chapter or in Chapter 9: Maintenance.
For additional assistance on any troubleshooting procedure,
contact Abbott Diagnostics Customer Service (at 1-877-4ABBOTT
in the US).

Obtaining Technical Assistance


Technical Assistance is obtained by calling Abbott Diagnostics
Customer Service. It is important to provide the Customer
Support Specialist with a clear and detailed description of the
problem. When assistance is needed, please be prepared to
provide the following information for the Customer Support
Specialist:
1. Instrument model number
2. Serial number of the Analyzer and software version in use
3. Description of the problem (whenever possible, print the Fault
Status Report obtainable from the DIAGNOSTICS MENU screen)
4. The lot numbers and expiration dates of the CELL-DYN
Reagents and Controls currently in use
5. Sufficient examples of data to facilitate the discussion

Customer Support Center


United States: 1-877-4ABBOTT (1-877-422-2688)
Abbott Diagnostics Customer Service:
200 Abbott Park Road
Abbott Park, IL 60064, USA
Canada: 1-800-387-8378
Customers outside the US: call your local Customer Service
Representative.

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Troubleshooting Procedures
The procedures in this section are for troubleshooting purposes
only. A specific procedure should be performed when indicated in
this chapter or at the request of an Abbott Customer Support
Specialist.

Power ON Procedure
IMPORTANT: If the power has been OFF more than five minutes,
the laser must be allowed to warm up for 15 minutes once the
power is turned back ON. Do not process samples during this
warm-up period.

1. Verify that all components are properly installed (for


example, syringes, Shear Valve, etc.).
2. Verify that all reagents are properly installed.
3. Verify that all necessary cables and power cords are properly
connected.
4. Verify that the Analyzer covers are properly installed. If the
instrument is a CELL-DYN 3700SL System, verify that the
Sample Loader safety cover is in place.
5. If applicable, verify that the cause of the power OFF situation
has been corrected.
6. Turn the power switches ON in the following order:
a. Analyzer
b. Data Station
c. Sample Loader, if present
d. Printer

7. When the INITIALIZED message appears in the Status Box


on the Data Station screen, prime the system by pressing
[PRIME] or [RUN], whichever is displayed.

Power OFF Procedure


It is not necessary to turn the system OFF under routine operating
conditions. The system should be turned OFF if certain services are
performed, if the system is moved, or if the system will be inactive
for an extended period of time (longer than seven days).
When controlled conditions (such as emergency power tests)
require the power to be turned OFF, use the following procedure.

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1. Perform any required maintenance that is due.


2. Perform an Auto-Clean Cycle. (If necessary, refer to the
directions given in Chapter 9: Maintenance, Subsection:
Daily Maintenance Procedures, Auto-Clean.)
3. When the Auto-Clean cycle is complete, press [DAILY
SHUTDOWN]. When the Daily Shutdown cycle is complete, the
Status Box displays the message: Standby.
NOTE: If the instrument will be inactive for more than
seven days, perform the Preparation for Inactivity or
Shipping cycle instead of the Daily Shutdown cycle. Refer
to the instructions given in Chapter 9: Maintenance,
Subsection: Special Procedures, Preparation for
Inactivity or Shipping.

4. Turn the power switches OFF in the following order:


a. Data Station
b. Analyzer
c. Sample Loader, if present
d. Printer
NOTE: In an emergency situation, turn OFF the power
switches, in any order, as quickly as possible. Follow the
Power ON procedure as described earlier in this section
when the emergency is over.

Initializing the System


The term initialization refers to the automatic process that is
necessary after certain problems have been corrected.
Initialization is a two-step process:

1. Initializing the hardware and software


2. Priming the system with reagents
The system is initialized by pressing the [INITIALIZATION] key on
the second DIAGNOSTICS MENU screen. The system is automatically
initialized whenever the power is turned ON.

During the initialization process, the Data Station software is


accessed and downloaded to the Analyzer. Once this is
accomplished, all Analyzer motors and pumps are moved to their
“home” positions. (Increased motor noises are normal during this
process.) When the initialization has been successfully completed,
the message INITIALIZED is displayed in the Status Box.

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The reagent priming step is necessary after any initialization. This


is accomplished by pressing [RUN] or [PRIME], whichever is
displayed. All reagents are primed automatically, a background
cycle is performed, and the results are displayed on the RUN
screen. After the reagents are primed and auto background is
performed, the message Ready is displayed in the Status Box.

On the CELL-DYN 3700SL System, the Sample Loader may be


initialized by pressing the INT key on the Sample Loader
operation keyboard. It may also be initialized by turning the
Sample Loader power switch OFF and ON. (The Sample Loader is
automatically initialized every time the power switch is turned ON.)

Replacing Reagents
If a reagent (or reagents) is suspected as the cause of a particular
problem, replace the container. However, the Analyzer has
reservoirs that contain a small amount of reagent to maintain the
supply within the system. This supply must be depleted before
installing the new reagent.

NOTE: There is no reservoir for the WIC/HGB lyse reagent.


The amount of lyse contained in the lyse supply tubing is
sufficient to maintain the system’s supply. The lyse tubing
is drained and filled with the [EMPTY LYSE] and [FILL LYSE]
keys displayed on the REAGENT RESERVOIR screen, using
the procedure described below.

To ensure that only new reagent is in the system, proceed as


follows:

1. From the first SPECIAL PROTOCOLS screen, press [REAGENT


RESERVOIR].
2. From the REAGENT RESERVOIR screen, follow the instructions
given on the screen.
3. Wipe the reagent line with a lint-free wipe before placing it
in the new container. Place the line in the container and
secure the cap.
4. To refill, follow the instructions given on the screen.
5. Run five background counts before assessing the results.

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Replaceable Components
Procedures are given in this section for those components that
may be replaced by the operator. All other components must be
replaced by an Authorized Service Representative.
WARNING: Potential Biohazard. Components may be
contaminated with infectious materials. Wear appropriate
personal protective equipment and follow biosafety
practices as specified in the OSHA Bloodborne Pathogen
Rule (29 CFR 1910.1030) or equivalent biosafety
procedures.

Fuse Replacement
The CELL-DYN 3700 System has a fuse located above the Power
Cord Connector on the Rear Panel. It should only be replaced
with the following types of fuses:
For 220-volt operation, a 4-amp T (slow-blow) fuse
For 110-volt operation, an 8-amp T (slow-blow) fuse
Replacement fuses are provided in the Accessory Kit.

Materials Required
Flathead screwdriver

Procedure
WARNING: Electrical Shock Hazard. Always turn the
System OFF and disconnect the Power Cord from the
receptacle before checking or changing the fuse.

1. Turn the Analyzer power switch OFF and disconnect the


power cord from the receptacle.
2. Insert a flathead screwdriver into the Fuse Holder Slot on the
Rear Panel of the Analyzer.
3. Push in and turn the Fuse Holder counterclockwise to
remove it.
4. Pull on the fuse to remove it from the holder.
5. Check the fuse. If it has obviously failed, replace it. If it has
not obviously failed, verify that it is the correct type of fuse.
NOTE: If you are not sure if the fuse has failed, replace it
and see if the problem is corrected.

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6. Check that the fuse is fully inserted into the Fuse Holder and
replace the holder.
7. Insert a flathead screwdriver into the Fuse Holder Slot and
push in, turning clockwise to lock it in place.
8. Reconnect the power cord to the receptacle and turn the
Analyzer power switch ON.

Sample Loader Vent Needle/Aspiration Needle Replacement

Pulley Belt
Blood Sensor A Sample
Aspiration
Vent Tubing
Tubing V

Silicon
Tubing
Sleeve Mounting
Block

Locking
Screw

Vent/ Vent Reservoir


Aspiration
Side Fitting
Needle

Vent Reservoir

Figure 10.22: Sample Loader Vent/Aspiration Needle Assembly

The Sample Loader Vent/Aspiration Needle should be replaced if it


is bent, or if it cannot be unclogged. The Sample Loader Vent/
Aspiration Needle Assembly tubing connections are depicted in
the preceding figure. The Vent and Aspiration Tubing connections
are shown in the following figure.

WARNING: Potential Biohazard. The needles are sharp and


are potentially contaminated with infectious materials.
Handle with extreme caution.

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A Sample
Aspiration
Vent Tubing
Tubing V

Aspiration
Tubing
Silicon Sleeve

Figure 10.23: Sample Loader Vent/Aspiration Needle — Tubing


Connections

Materials Required
1. Sample Loader Vent/Aspiration Needle, L/N 03H99-01
(provided in the Accessory Kit)
2. Enzymatic Cleaner in a VACUTAINER tube
3. Gauze
4. A 2.5-mm Allen wrench
5. Two VACUTAINER tubes approximately half full of Diluent
6. Small needle nose pliers or similar tool.

Procedure
1. Perform the Auto-Clean procedure as directed in Chapter 9:
Maintenance, Subsection: Daily Maintenance Procedures,
Auto-Clean. When the cycle is complete, turn the Sample
Loader power switch OFF.
2. Remove all racks from the tray.
3. Place some gauze under the Vent/Aspiration Needle to catch
any liquid.

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4. Disable the Analyzer by pressing the [DISABLE ANALYZER] key


on the SPECIAL PROTOCOLS screen.
5. Disconnect the Sample Aspiration Tubing from the Analyzer.
NOTE: The tubing connection is located below the Status
Panel to the left side of the Open Sample Aspiration Probe.

6. Remove the Sample Loader Tower Cover.


7. Manually rotate the Pulley Belt counterclockwise until the
needle is fully bottomed.
8. Mark the sets of tubing connected to the top of the vent and
aspirate parts of the needle “V” and “A” to aid in proper
reconnection.
NOTE: The needle is divided into the aspiration section
(straight) and the vent section (slanted).

9. Disconnect the “A” tubing from the needle. Slide the silicon
tubing sleeve onto the aspiration tubing before
disconnecting it. (See the preceding figure.) Disconnect the
“V” tubing from the Vent/Aspiration Needle.
10. Use the Allen wrench to remove the locking screw on the
mounting bracket. (See Figure 10.22, Sample Loader Vent/
Aspiration Needle Assembly.)
11. Using the needle nose pliers, grip the holding clip on the
mounting block and carefully pull it forward until it clears
the block.
12. Remove the needle by pulling it up through the Wash Block
and the mounting block.
WARNING: Potential Biohazard. The needles are sharp and
are potentially contaminated with infectious materials.
Handle with extreme care.

CAUTION: Use care when removing or inserting the needle


to avoid skin puncture.

13. Insert the new needle through the mounting bracket and
down through the Wash Block until the wide collar at the
top of the needle is flush with the top of the mounting
bracket.
NOTE: Be sure that the vent section (slanted) is facing the
analyzer.

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14. Slide the holding clip back onto the mounting block and
push in until it is snug against the block.
15. Using the Allen wrench, replace and tighten the locking
screw in the mounting bracket.
16. Reconnect the vent tubing and the aspiration tubing.
NOTE: When connected, the aspiration tubing must be
placed at least 1/4 inch over the top of the needle to cover
it. The silicon tubing sleeve must slide over this
connection for a proper seal.

17. Reconnect the Sample Aspiration Tubing to the Analyzer.


CAUTION: Be careful not to crimp or bend the tubing
when reconnecting it. Do not use excessive force.

18. Replace the tower cover and check all tubing to ensure it is
not pinched or crimped.
19. Reinstall all Sample Loader Racks. Prepare the first rack to
run two diluent tubes. Install Safety Cover.
20. Enable the Analyzer by pressing the [ENABLE ANALYZER] key
on the SPECIAL PROTOCOLS screen.
21. Turn the Sample Loader power switch ON.
22. Run the two diluent tubes and verify proper needle
movement. Check to be sure the background count is
acceptable on the last cycle.
NOTE: If the background count is unacceptable, clean the
aspiration needle as directed in Chapter 9: Maintenance,
Subsection: Daily Maintenance Procedures and repeat the
background count. If any problems are encountered, call
Abbott Diagnostics Customer Service for assistance
(at 1-877-4ABBOTT in the US).

Apertures
It may be necessary to replace the WIC Aperture Plate and/or the
RBC/PLT Aperture Plate if no other solution to a related problem
is found.
WIC apertures are identified by “WBC” etched on the Aperture
Plate. RBC/PLT apertures are identified by “R/P” etched on the
Aperture Plate.

NOTE: The Aperture Plates are NOT interchangeable.

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Procedure
1. Remove the old Aperture Plate as directed in the aperture
cleaning procedure described in Chapter 9: Maintenance,
Subsection: As required, Aperture Plates.
2. Confirm that the replacement Aperture Plate is the correct one.
3. Clean the new Aperture Plate and install it as directed in the
aperture cleaning procedure described in Chapter 9:
Maintenance, Subsection: As Required, and follow the
remaining steps in that procedure.
CAUTION: Changing the Aperture Plate may alter the
instrument calibration. Therefore, confirm the calibration
by running commercial controls before processing
samples. If necessary, recalibrate the instrument as
directed in Chapter 6: Calibration.

4. Repeat the samples that were running when the problem was
detected to determine if it has been resolved. If the problem
is not resolved, call Abbott Diagnostics Customer Service for
assistance (at 1-877-4ABBOTT in the US).

Syringes
It may be necessary to replace a syringe to correct a problem, for
example, if a syringe is cracked or broken.

Procedure
1. Remove the syringe in question as directed in the
appropriate syringe cleaning procedure described in
Chapter 9: Maintenance and set it aside.
2. Remove the screw from the base of the plunger on the old
syringe. Install the screw on the base of the new syringe
before installing the syringe on the instrument.
3. Install the new syringe as directed in the appropriate syringe
cleaning procedure and follow the remaining steps in that
procedure.
4. Repeat the samples that were in process when the problem was
detected to determine if it has been resolved. If the problem
is not resolved, call Abbott Diagnostics Customer Service for
assistance (at 1-877-4ABBOTT in the US).

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List of Symptoms
Troubleshooting Background Counts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-39
Platelet background out of specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-40
WOC background out of specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-41
WIC background out of specification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-42
RBC background out of specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-43
Hemoglobin background out of specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-44
Multiple background counts out of specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-45
Troubleshooting Incomplete Aspiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-46
Sampling Error — Incomplete Aspiration: Open Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . .10-47
Sampling Error — Incomplete Aspiration: Closed Mode (Cap Piercer System) . . . . . . . . 10-48
Sampling Error — Incomplete Aspiration: Closed Mode (Sample Loader System) . . . . . . .10-49
Troubleshooting Clog and Flow Error Messages for RBC/PLT and WIC . . . . . . . . . . . . . . . . . . . . 10-50
RBC/PLT clog or flow errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-51
WIC clog or flow errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-52
Troubleshooting WOC Flow Errors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-53
WOC flow errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-54
Troubleshooting Imprecise or Inaccurate Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-55
RBC/MCV/PLT data are imprecise or inaccurate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-56
WOC data are imprecise or inaccurate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-58
WIC data are imprecise or inaccurate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-59
Hemoglobin data are imprecise or inaccurate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-60
>>>> appear in place of the result for WBC, RBC, HGB, or PLT . . . . . . . . . . . . . . . . . . . . .10-61
Observable Fault Conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-62
Analyzer or Data Station will not power ON . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-62
No screen display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-62
The MAIN MENU screen is not displayed after initialization . . . . . . . . . . . . . . . . . . . . . 10-63
The word FAULT on the Analyzer Status Indicator Panel is illuminated in red . . . . . . . . 10-63
Instrument will not stop cycling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-64
The Data Station keyboards, membrane (including soft keys) and external,
are not operational . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-64
The Sample Loader does not power ON . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-65
The Sample Loader beeps and the Start key is not illuminated . . . . . . . . . . . . . . . . . . . . 10-65
Shear Valve problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-65

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Chapter 10 Troubleshooting Guide

Symptom Identification and Resolution


Troubleshooting Background Counts
The following list contains some general guidelines for
troubleshooting background counts.
• Determine which parameter(s) exceed the background count
specifications: WIC, WOC, RBC, PLT, HGB. If more than one
parameter is out of specification, refer to Multiple background
counts out of specification at the end of the Troubleshooting
Background Counts subsection.
• Check the Data Log to determine when the problem first
occurred.
• Check the Reagent Log, Maintenance Log, and if applicable,
service reports to see if the problem occurred immediately
after a specific action. For example, did the problem occur
immediately after the reagent was changed?
• Ensure that all covers are in place and ground wires are
connected.
• Check the background count in the Open and Closed Modes
to see if the problem is common to both modes.
• Run the electrical background and obtain a printout. Note
whether the count is within acceptable limits.
NOTE: The electrical background cycle turns off the
current to the apertures. This cycle is used to assist in
determining if the electronics are causing the problem.
• Note the lot number of the reagent. Is it a new lot?
• Configure the RUN screen to display the appropriate graph
for the parameter(s) for which the background count exceeds
the system specifications and print the appropriate graph.
Parameter Appropriate Graph
WIC WIC histogram
WOC Size/Complexity scatterplot and the
NWBC-LYM-MONO histogram
RBC RBC and PLT histograms
PLT RBC and PLT histograms
HGB WIC, RBC and PLT histograms
NOTE: Instructions for customizing the RUN screen display
are given in Chapter 5: Operating Instructions.
• Refer to the following tables for the appropriate corrective
action.

CELL-DYN® 3700 System Operator’s Manual 10-39


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Troubleshooting
Troubleshooting Guide Chapter 10

Platelet background out of specification


Probable Cause(s) Corrective Action
Electrical Interference If the Analyzer covers have been
removed, replace covers, reattach the
ground wires, and rerun the background
count.
Perform an electrical background count.
Clean the Fan Filters (as directed in
Chapter 9).
Drain the Vacuum Accumulator.
Check for any equipment near the
CELL-DYN 3700 System that may be
causing electrical interference.
Contaminated Reagent Empty the RBC/PLT Diluent Reservoir.
Replace the Diluent Reagent.
NOTE: To prevent contamination, place
the Reagent tubing on a clean surface.
Dirty RBC/PLT Aperture Plate Clean the RBC/PLT Aperture Plate (as
directed in Chapter 9).
Contaminated/dirty RBC/PLT Diluent Clean the RBC Diluent Syringe (as
Syringe directed in Chapter 9).
Salt buildup around RBC/PLT von Perform Auto-Clean or Extended
Behrens Transducer Assembly Auto-Clean.
NOTE: After performing any maintenance or troubleshooting procedures, run at least 5
background counts. Ensure that the controls are in range.

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Chapter 10 Troubleshooting Guide

WOC background out of specification


Probable Cause(s) Corrective Action
Bubbles in WOC Flow Cell Empty WOC Flow Cell.
Bubbles in WOC Syringes Clean the WOC Sheath Syringe and the
WOC Metering Syringe (as directed in
Contaminated WOC Syringes
Chapter 9).
Dirty WOC Flow Cell Perform the Auto-Clean Procedure (as
directed in Chapter 9).
Contaminated Reagent Empty the Sheath Reservoir.
Replace the Sheath Reagent.
NOTE: To prevent contamination, place
the Reagent tubing on a clean surface.
Faulty WOC Peristaltic Pump Tubing Replace the WOC Transfer Peristaltic
Pump Tubing (as directed in Chapter 9).
NOTE: After performing any maintenance or troubleshooting procedures, run at least 5
background counts. Ensure that the controls are in range.

CELL-DYN® 3700 System Operator’s Manual 10-41


9140320C — November 2000
Troubleshooting
Troubleshooting Guide Chapter 10

WIC background out of specification


Probable Cause(s) Corrective Action
Electrical Interference If the Analyzer covers have been
removed, replace covers, reattach the
ground wires, and rerun the background
count.
Perform an electrical background count.
Clean the Fan Filters (as directed in
Chapter 9).
Check for any equipment near the
CELL-DYN 3700 System that may be
causing electrical interference.
Dirty WIC Aperture Plate Clean the WIC Aperture Plate (as directed
in Chapter 9).
Contaminated Reagent Empty the Diluent Reservoir.
Replace the Diluent Reagent.
Empty the Detergent Reservoir.
Replace the Detergent Reagent.
Empty the WIC/HGB Lyse.
NOTE: To prevent contamination, place
the Reagent tubing on a clean surface.
Contaminated/dirty WIC/HGB Diluent Clean the WIC/HGB Diluent Syringe (as
Syringe directed in Chapter 9).
Contaminated/dirty WIC/HGB Lyse Clean the WIC/HGB Lyse Syringe (as
Syringe directed in Chapter 9).
Faulty Aperture Clean Circuit Call Abbott Diagnostics Customer Service
(at 1-877-4ABBOTT in the US).
NOTE: After performing any maintenance or troubleshooting procedures, run at least 5
background counts. Ensure that the controls are in range.

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Chapter 10 Troubleshooting Guide

RBC background out of specification


Probable Cause(s) Corrective Action
Electrical Interference If the Analyzer covers have been
removed, replace covers, reattach the
ground wires, and rerun the background
count.
Perform an electrical background count.
Clean the Fan Filters (as directed in
Chapter 9).
Check for any equipment near the
CELL-DYN 3700 System that may be
causing electrical interference.
Dirty RBC/PLT Aperture Plate Clean the RBC/PLT Aperture Plate (as
directed in Chapter 9).
Contaminated Reagent Empty the RBC/PLT Diluent Reservoir.
Replace the Diluent Reagent.
NOTE: To prevent contamination, place
the reagent tubing on a clean surface.
Contaminated/dirty RBC/PLT Diluent Clean the RBC/PLT Diluent Syringe (as
Syringe directed in Chapter 9).
NOTE: After performing any maintenance or troubleshooting procedures, run at least 5
background counts. Ensure that the controls are in range.

CELL-DYN® 3700 System Operator’s Manual 10-43


9140320C — November 2000
Troubleshooting
Troubleshooting Guide Chapter 10

Hemoglobin background out of specification


Probable Cause(s) Corrective Action
Dirty HGB Flow Cell Clean the HGB Flow Cell (as directed in
Chapter 9).
Check HGB reference reading by pressing
the [RAW DATA SUMMARY] key on the
DIAGNOSTICS MENU screen.
Malfunctioning HGB Flow Cell Check HGB reference reading by pressing
the [RAW DATA SUMMARY] key on the
DIAGNOSTICS MENU screen.
Contaminated Reagent Empty the Diluent Reservoir.
Replace the Diluent Reagent.
Empty the WIC/HGB Lyse Reservoir.
Replace the WIC/HGB Lyse Reagent.
NOTE: To prevent contamination, place
the Reagent tubing on a clean surface.
Contaminated/dirty WIC/HGB Diluent Clean the WIC/HGB Diluent Syringe.
Syringe
NOTE: After performing any maintenance or troubleshooting procedures, run at least 5
background counts. Ensure that the controls are in range.

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Chapter 10 Troubleshooting Guide

Multiple background counts out of specification


NOTE: The WBC background count is always the highest of the two (WIC or WOC)
measurements. If the WBC background exceeds the limits, check the WIC and
WOC values and determine which method to troubleshoot. (To check WIC
and WOC, the Data Log must be configured to display them according to the
directions given in Chapter 5: Operating Instructions.)
Probable Cause Corrective Action
1. The Analyzer front covers are removed. 1. Verify that the ground wires are
securely connected and replace the
front covers. Repeat the background
count.
2. Debris is present in the system or on 2. From the second SPECIAL PROTOCOLS
the Aperture Plate. screen, press [AUTO CLEAN] to clean the
system. When the cycle is complete,
repeat the background count. Remove
and clean the appropriate Aperture
Plate (as directed in Chapter 9). Repeat
the background count.
3. The reagents are cold. 3. Allow the reagents to warm to room
temperature and then repeat the
NOTE: If reagents were frozen — discard.
background count.
4. There is liquid in the Vacuum 4. From the second DIAGNOSTICS MENU
Accumulator. screen, press the [DRAIN ACCUMULAT]
key. When the cycle is complete,
initialize the Analyzer by pressing the
[INITIALIZATION] key on the second
DIAGNOSTICS MENU screen. Repeat the
background count.
5. There are bubbles in the Diluent 5. Clean the Diluent Syringe (as directed
Syringe. in Chapter 9).
6. The Shear Valve is dirty. 6. Clean the Shear Valve (as directed in
Chapter 9). Repeat the background
count.

CELL-DYN® 3700 System Operator’s Manual 10-45


9140320C — November 2000
Troubleshooting
Troubleshooting Guide Chapter 10

Troubleshooting Incomplete Aspiration


If the sample is not detected by the Blood Sensor, an aspiration
error occurs. The message Sampling Error — Incomplete
Aspiration appears on the screen. The following list contains
some general guidelines for troubleshooting aspiration errors.
• Check to see if the problem occurs in both the Open and
Closed Modes of operation. If the problem is confined to one
mode only, the other may be eliminated as the cause of the
problem.
• Determine whether the problem is a true incomplete
aspiration. Run a sample and verify that blood is visible in
the sample tubing above the appropriate probe or needle.
• Verify that blood is pulled through the Shear Valve. Blood
should be visible in the lines (approximately one inch) on
both sides of the Shear Valve before it rotates.
• Refer to the following tables for the appropriate corrective
action.

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Chapter 10 Troubleshooting Guide

Sampling Error – Incomplete Aspiration: Open Mode


Probable Cause(s) Corrective Action
Inadequate blood is aspirated. Check for sufficient sample in specimen
tube.
Check for clotted sample.
Flush Open Sample Aspiration Probe.
Check “Y” fitting behind Status Panel for
clogs. Flush if needed.
Clean the Shear Valve (as directed in
Chapter 9).
Replace the Sample Aspiration Peristaltic
Pump Tubing (as directed in Chapter 9).
The trailing edge of the sample is pulled Check that the Sample Aspiration
completely through the Shear Valve Peristaltic Pump tubing is inserted
before it rotates. correctly in the Peristaltic Pump.
Replace the Sample Aspiration Peristaltic
Pump Tubing (as directed in Chapter 9).
Adequate blood is aspirated. Specimen may be very viscous (for
example, Myeloma or Polycythemia) or
very “thin” (for example, severe anemia
or dialysis). The aspiration error may
continue with these types of samples.
Rerun sample and ensure that blood is
visible in the Sample Tubing above the
appropriate probe or needle.
Rerun sample and ensure that blood is
visible on both sides of the Shear Valve.
Check Blood Sensors.
NOTE: After performing any maintenance or troubleshooting procedures, run at least 5
background counts. Ensure that the controls are in range.

CELL-DYN® 3700 System Operator’s Manual 10-47


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Troubleshooting
Troubleshooting Guide Chapter 10

Sampling Error – Incomplete Aspiration: Closed Mode


(Cap Piercer System)
Probable Cause(s) Corrective Action
Inadequate blood is aspirated. Check for sufficient sample in specimen
tube.
Check for clotted sample.
Flush probe.
Check “Y” fitting behind Status Panel for
clogs. Flush if needed.
Clean the Shear Valve (as directed in
Chapter 9).
Clean the SL Aspiration needle (as
directed in Chapter 9).
Replace the Sample Aspiration Peristaltic
Pump Tubing (as directed in Chapter 9).
Sample is pulled completely through the Check that the Sample Aspiration
Shear Valve before the sample cut is Peristaltic Pump tubing is inserted
made. correctly into the Sample Aspiration
Peristaltic Pump.
Replace the Sample Aspiration Peristaltic
Pump Tubing (as directed in Chapter 9).
Adequate blood is aspirated. Specimen may be very viscous (for
example, Myeloma or Polycythemia) or
very “thin” (for example, severe anemia
or dialysis). The aspiration error may
continue with these types of samples.
Rerun sample and ensure that blood is
visible on both sides of the Shear Valve.
Check Blood Sensors.
NOTE: After performing any maintenance or troubleshooting procedures, run at least 5
background counts. Ensure that the controls are in range.

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Chapter 10

Sampling Error – Incomplete Aspiration: Closed Mode


(Sample Loader System)
Probable Cause(s) Corrective Action
Inadequate blood is aspirated. Check for sufficient sample in specimen
tube.
Check for clotted sample.
Flush probe.
Check “Y” fitting behind Status Panel for
clogs. Flush if needed.
Clean the Shear Valve (as directed in
Chapter 9).
Clean the SL Aspiration needle (as
directed in Chapter 9).
Replace the Sample Aspiration Peristaltic
Pump Tubing (as directed in Chapter 9).
Sample is pulled completely through the Check that the Sample Aspiration
Shear Valve before the sample cut is Peristaltic Pump tubing is inserted
made. correctly into the Sample Aspiration
Peristaltic Pump.
Replace the Sample Aspiration Peristaltic
Pump Tubing (as directed in Chapter 9).
Adequate blood is aspirated. Specimen may be very viscous (for
example, Myeloma or Polycythemia) or
very “thin” (for example, severe anemia
or dialysis). The aspiration error may
continue with these types of samples.
Rerun sample and ensure that blood is
visible on both sides of the Shear Valve.
Check Blood Sensors.
NOTE: After performing any maintenance or troubleshooting procedures, run at least 5
background counts. Ensure that the controls are in range.

CELL-DYN® 3700 System Operator’s Manual 10-49


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Troubleshooting
Chapter 10

Troubleshooting Clog and Flow Error Messages for RBC/PLT and WIC
The following list contains some general guidelines for
troubleshooting RBC/PLT and WIC clog and flow errors.

• Determine which metering process exhibits the problem, WIC


or RBC/PLT.
• Remove the front covers and observe the appropriate metering
tube while a cycle is in progress. (Refer to the following
figure.) Approximately 10–15 seconds after the start of the
cycle, the metering tube should be flushed of all liquid.
Observe that the liquid is completely flushed from the tube.
After flushing, a liquid column with a meniscus at the leading
edge should travel down the tube. Observe that the meniscus
is visible at the leading edge. A complete flush of the tube
and a uniform meniscus are important to correct metering.

Start
Detector
(Count
Meniscus Initiated)

Count
Time

Stop
Detector
(Count
Completed)

Figure 10.24: Volumetric Metering

• Print the RUN screen to record the metering times. The upper
metering time and the count time are both important in
troubleshooting clogs or flow errors.
• The metering times are automatically stored in the Data Log.
Configure the Data Log to display and print the appropriate
upper metering time and count time. (If necessary, refer to
the directions given in Chapter 5: Operating Instructions.)

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• Additional information regarding the count times from the


previously run cycle can be found on the RAW DATA
SUMMARY screen.
NOTE: The information is only available immediately
after the cycle is completed. Therefore, the screen should
be printed immediately after the clog or flow error occurs.

From the first DIAGNOSTICS MENU screen, press [RAW DATA


SUMMARY] followed by [PRINT] to obtain a printout.
• Information pertaining to the vacuum level in the Analyzer
can be found on the VOLTAGE READINGS screen.
From the third DIAGNOSTICS MENU screen, press [VOLTAGE
READINGS] followed by [PRINT] to obtain a printout.

RBC/PLT clog or flow errors


Probable Cause(s) Corrective Action
RBC/PLT Aperture Plate Press [CLEAR APERTURES] (RUN screen
menu function).
Clean the RBC/PLT Aperture Plate (as
directed in Chapter 9).
Check aperture microscopically using low
power objective for scratches or cracks.
Check volumetric metering tube for
appropriate meniscus.
Check to make sure the Aperture Plate is
properly installed.
Check for appropriate installation of
correct Reagents.
Check sample for clots.
RBC/PLT Transducer Observe bubble mix during run cycle.
Verify Transducer is emptying correctly.
NOTE: After performing any maintenance or troubleshooting procedures, run at least 5
background counts. Ensure that the controls are in range.

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Chapter 10

WIC clog or flow errors


Probable Cause(s) Corrective Action
WIC Aperture Plate Press [CLEAR APERTURES] (RUN screen
menu function).
Clean the WIC Aperture Plate (as directed
in Chapter 9).
Check aperture microscopically using low
power objective for scratches or cracks.
Check volumetric metering tube for
appropriate meniscus.
Check to make sure the Aperture Plate is
properly installed.
Check for appropriate installation of
correct reagents.
Check sample for clots.
WIC Transducer Observe bubble mix during run cycle.
Verify WIC Transducer is draining
completely.
NOTE: After performing any maintenance or troubleshooting procedures, run at least 5
background counts. Ensure that the controls are in range.

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Chapter 10

Troubleshooting WOC Flow Errors


The following list contains some general guidelines for
troubleshooting WOC flow errors.

• The message: WOC FLOW ERROR indicates a problem with the


kinetic rate of the WOC measurement. The kinetic information
is shown on the COUNT RATE SUMMARY screen, which is
available only immediately after the cycle is complete.
Therefore, the COUNT RATE SUMMARY screen should be
printed immediately after the WOC flow error occurs.
• From the first DIAGNOSTICS MENU screen, press [CNT RATE
SUMMARY].
• Press the [WOC CNT RATE] key to display the data for the
kinetic rate followed by the [PRINT] key to obtain a printout.
• Press the [WOC CNT GRAPH] key to display the graph of the
kinetic data followed by the [PRINT] key to obtain a printout.
• Configure the RUN screen to display the Size/Complexity
scatterplot and the NWBC-LYM-MONO histogram. This
information can help to determine if the flow is erratic or
just momentarily interrupted. (If necessary, refer to the
instructions given in Chapter 5: Operating Instructions.)

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Troubleshooting
Chapter 10

WOC flow errors


Probable Cause(s) Corrective Action
Inappropriate kinetic rate of the WOC Obtain kinetic rate information from
measurement count rate summary in the DIAGNOSTICS
MENU.
NOTE: Kinetic information is only
available immediately after the cycle is
complete. Therefore the screen should be
accessed after the WOC flow error occurs.
Replace the WOC Transfer Peristaltic
Pump Tubing (as directed in Chapter 9).
Check the WOC Metering Syringe for
smooth movement during the cycle.
Check the WOC Metering Syringe for
bubbles.
Check the WOC Sheath Syringe for
bubbles.
Clean the WOC Sheath and WOC Metering
Syringes (as directed in Chapter 9).
NOTE: After performing any maintenance or troubleshooting procedures, run at least 5
background counts. Ensure that the controls are in range.

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Chapter 10

Troubleshooting Imprecise or Inaccurate Data


The following list contains some general guidelines for
troubleshooting imprecision.

• Obtain a normal blood sample. Select an empty QC file and


run a minimum of 10 Open Mode runs into the file. Obtain
a printout.
• Run a minimum of 10 Closed Mode runs into the same file.
Use the [REJECT SPECIMEN] key to reject the Open Mode runs
and obtain a printout. This information can be used to
determine if the problem is mode or measurement related.
• Obtain a printout of the RAW DATA SUMMARY screen
immediately after the problem sample is run. From the first
DIAGNOSTICS MENU screen, press the [RAW DATA SUMMARY]
key followed by the [PRINT] key to obtain a printout.
Obtain a printout of the X-B RBC or X-B WBC data. From the
MAIN MENU screen, press the [QUALITY CONTROL] key followed
by the [X-B FILE] key. If necessary, press the [X-B RBC DATA] or
[X-B WBC DATA] key to display the appropriate X-B data and
press the [PRINT] key to obtain a printout.

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Troubleshooting
Chapter 10

RBC/MCV/PLT data are imprecise or inaccurate


Cause of Inaccurate Result Corrective Action
Worn Sample Aspiration Peristaltic Pump Replace the Sample Aspiration Peristaltic
Tubing Pump Tubing (as directed in Chapter 9).
Shear Valve is not operating smoothly Clean the Shear Valve (as directed in
Chapter 9).
Bubbles or malfunction in RBC/PLT Clean the RBC/PLT Diluent Syringe (as
Diluent Syringe directed in Chapter 9).
Replace the RBC/PLT Diluent Syringe (as
directed in Chapter 9).
Dirty specimen path Perform the Auto-Clean Procedure (as
directed in Chapter 9).
Clean the Shear Valve (as directed in
Chapter 9).
Inadequate mixing and/or draining in the Trace air inlet lines for obstructions or
RBC/PLT mixing chamber crimps.
Clean the RBC/PLT Aperture Plate (as
directed in Chapter 9).
Fragmented RBCs falsely elevate the Review a stained blood smear for the
platelet count presence of fragmented RBCs.
Perform the platelet count by an alternate
method.
Extremely microcytic RBCs may be Review a stained blood smear for the
counted as platelets presence of extremely microcytic RBCs.
Perform the platelet count by an alternate
method.
The RBCs are hyperosmolar in Rerun the specimen.
comparison to the diluent; therefore,
Use a microhematocrit procedure to
water is drawn into the RBCs causing the
determine the HCT value and calculate
RBCs to swell and falsely increase the
the MCV and MCHC.
MCV
Red blood cell aggregates falsely decrease Warm the specimen and rerun.
the RBC count
NOTE: The MCV should not change
NOTE: The MCV should be accurate significantly after rerun.
because of Red Cell Editing Ratio (RER).

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Chapter 10

Platelet clumps falsely decrease the Check the specimen for clots and/or the
platelet count stained blood smear for platelet clumps.
Recollect the specimen using proper
technique.
Rerun the specimen.
Electrical interference If Analyzer covers have been removed,
replace them and reconnect the ground
wires.
Perform an electrical background count.
Clean the Fan Filters (as directed in
Chapter 9).
Check for any equipment near the
CELL-DYN 3700 System that may be
causing electrical interference.
Contaminated Reagent Empty the RBC/PLT Diluent Reservoir.
Replace the reagent with a new box of
reagent.
NOTE: To prevent contamination, place
the Reagent tubing on a clean surface.
Dirty RBC/PLT Aperture Plate Clean the RBC/PLT Aperture Plate (as
directed in Chapter 9).
The RBC/PLT Diluent Syringe contains Clean the RBC/PLT Diluent Syringe (as
salt crystals directed in Chapter 9).

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Troubleshooting
Chapter 10

WOC data are imprecise or inaccurate


Cause of Inaccurate Result Corrective Action
Worn Sample Aspiration Peristaltic Pump Replace the Sample Aspiration Peristaltic
Tubing Pump Tubing (as directed in Chapter 9).
Worn WOC Transfer Peristaltic Pump Replace the WOC Transfer Peristaltic
Tubing Pump Tubing (as directed in Chapter 9).
Shear Valve is not operating smoothly Clean the Shear Valve (as directed in
Chapter 9).
Bubbles or malfunction in WOC Sheath Clean the appropriate WOC Syringe (as
Syringe or WOC Metering Syringe directed in Chapter 9).
Replace the appropriate WOC Syringe (as
directed in Chapter 9).
Dirty specimen path Perform the Auto-Clean Procedure (as
directed in Chapter 9).
Clean the Shear Valve (as directed in
Chapter 9).
Dirty WOC Flow Cell Perform the Auto-Clean Procedure.
Clean the WOC Sheath Syringe.
Bubbles in WOC Flow Cell Empty and refill the WOC Flow Cell using
SPECIAL PROTOCOLS menu features.
Incorrect, contaminated, or expired Verify that the reagent lines are inserted
reagents into the correct reagent containers.
Verify that the reagents have not expired.
Replace Sheath Reagent if necessary.
Inadequate mixing in the WOC Mixing Trace pressure and air inlet lines for
Chamber obstructions or crimps.
Check the pressure on Pressure Pump #3
(listed on the VOLTAGE READINGS
SUMMARY screen under VPM press 3 psi).
Voltage drift Check Channels 1, 2, 3, and 4 offset of the
MAM (Main Amp Module). (On the VOLTAGE
READING SUMMARY screen in the DIAGNOSTICS
screen under MAM: Ch 1 offset:, etc.)
If any MAM Offset reading is greater than
2.00, perform Auto-Clean. If the MAM
Offset reading remains greater than 2.00,
Contact Abbott Diagnostics Customer
Service.

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Chapter 10

Certain red blood cells (for example, Rerun specimen under [RESISTANT RBC].
hypochromic RBC or RBC containing large
amounts of HGB S, C, or F) may not be
completely lysed by the Sheath Reagent and
cause interference with the WOC count.
Laser light is not on Check MAM 1, 2, 3, and 4 Offset readings
on the VOLTAGE READING SUMMARY screen
in the DIAGNOSTICS MENU.
If the readings are 0.0, the laser or laser
power supply has malfunctioned.

WIC data are imprecise or inaccurate


Cause of Inaccurate Result Corrective Action
Worn Sample Aspiration Peristaltic Pump Replace the Sample Aspiration Peristaltic
Tubing Pump Tubing (as directed in Chapter 9).
Shear Valve is not operating smoothly Clean the Shear Valve (as directed in
Chapter 9).
Malfunction in WIC/HGB Diluent Syringe Clean the appropriate Syringe (as directed
or WIC/HGB Lyse Syringe in Chapter 9).
Replace the appropriate Syringe (as
directed in Troubleshooting Procedures
within this chapter).
Bubbles in WIC/HGB Diluent Syringe or Clean the appropriate Syringe (as directed
WIC/HGB Lyse Syringe in Chapter 9).
Dirty specimen path Perform the Auto-Clean Procedure (as
directed in Chapter 9).
Clean the Shear Valve (as directed in
Chapter 9).
Incorrect, contaminated, or expired Verify that the reagent lines are inserted
reagents into the correct reagent containers.
Verify that the reagents have not expired.
Replace reagent as required.
Inadequate mixing in the von Behrens Trace air inlet lines for obstructions or
WIC/HGB Transducer crimps.

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Troubleshooting
Chapter 10

Hemoglobin data are imprecise or inaccurate


Cause of Inaccurate Result Corrective Action
Worn Sample Aspiration Peristaltic Pump Replace the Sample Aspiration Peristaltic
Tubing Pump Tubing (as directed in Chapter 9).
Malfunctioning WIC/HGB Diluent Clean the appropriate Syringe (as directed
Syringe or WIC/HGB Lyse Syringe in Chapter 9).
Replace the appropriate Syringe (as
directed in Chapter 9).
Bubbles in WIC/HGB Diluent Syringe or Clean the appropriate Syringe (as directed
WIC/HGB Lyse Syringe in Chapter 9).
Dirty specimen path Perform the Auto-Clean Procedure (as
directed in Chapter 9).
Clean the Shear Valve (as directed in
Chapter 9).
Incorrect, contaminated, or expired Verify that the reagent lines are inserted
reagents into the correct reagent containers.
Verify that the reagents have not expired.
Replace reagent as required.
Inadequate mixing in the von Behrens Trace air inlet lines for obstructions or
WIC/HGB Transducer crimps.
A dirty Hemoglobin Flow Cell Perform the Auto-Clean Cycle (as directed
in Chapter 9).
Run a background count and a normal
blood specimen; check the Hemoglobin
Reference in the RAW DATA SUMMARY
screen in the DIAGNOSTICS MENU. Verify
that the Hemoglobin Reference values are
within 2050 ± 200.
Clean the Hemoglobin Flow Cell if the
Reference Value is < 1850. If the
Hemoglobin Reference Value is > 2250, call
Abbott Diagnostics Customer Service.
Elevated triglycerides may cause turbidity Centrifuge the specimen. Remove a
in the HGB dilution specific volume of plasma and replace
with an equal volume of diluent.
A high bilirubin absorbs enough light at
Resuspend the red blood cells. Rerun.
540 nm to increase the HGB
OR OR

Free plasma HGB from in vivo hemolysis Determine the plasma HGB and calculate
the corrected HGB concentration:
Corrected HGB = Whole Blood HGB -
[Plasma HGB x (1-HCT)] and Recalculate
the MCH and MCHC.

10-60 CELL-DYN® 3700 System Operator’s Manual


9140320E — September 2004
Troubleshooting
Chapter 10

>>>> appear in place of the result for WBC, RBC, HGB or PLT
NOTE: When the WOC or WIC result is replaced with >>>>, the HGB result is
suppressed. <<<< displays to indicate that the HGB is affected by the elevated WOC or
WIC value.
Cause of Inaccurate Result Corrective Action
Data exceed linear range for that For RBC or HGB: Dilute a 0.5-mL aliquot
parameter of well-mixed whole blood with 0.5 mL of
diluent (1:2 ratio). Close the container
and invert it 10 to 15 times to mix. Run
the specimen as usual. Multiply the RBC
or HGB result by 2 to obtain a reportable
value.

For WBC or PLT: Dilute a 0.5-mL aliquot


of well-mixed whole blood with 0.5 mL of
diluent (1:2 ratio) or 1 mL (1:3), 1.5 mL
(1:4), or 4.5 mL (1:10) of diluent as
required. Close the container and invert it
10 to 15 times to mix. Run the specimen
as usual. Multiply each WBC or PLT result
by 2, 3, 4, or 10 (per ratio of diluent to
blood used above) to obtain a reportable
value.

CELL-DYN® 3700 System Operator’s Manual 10-61


9140320F — April 2007
Troubleshooting
Chapter 10

Observable Fault Conditions

Analyzer or Data Station will not power ON.


Probable Cause Corrective Action
1. Power source is defective. 1. Verify that the power switch is turned
OFF and connect the system to a
different power source.
2. Power cord is not securely connected to 2. Ensure that the power cord is securely
the Analyzer or is not connected to the connected to the Analyzer or Data
power outlet. Station and verify that it is connected
to the power outlet.
3. Analyzer fuse is blown or incorrect. 3. The Analyzer fuse is located above the
power cord connector on the rear
panel. Check the fuse as directed in
Troubleshooting Procedures within
this chapter.
WARNING: Electrical Shock
Hazard. Always turn the
Analyzer power switch OFF and
disconnect the power cord from
the receptacle before checking or
replacing any fuse.
4. Defective power switch or other system 4. Call Abbott Diagnostics Customer
malfunction. Service for assistance
(at 1-877-4ABBOTT in the US).

No screen display.
Probable Cause Corrective Action
1. Monitor power switch is turned OFF. 1. Turn the monitor power switch ON.
2. Data Station power switch is turned 2. Turn the power switch ON.
OFF.
3. Brightness control is turned down. 3. Adjust the brightness control on the
Data Station until the image is visible.
4. Defective Data Station or other 4. Call Abbott Diagnostics Customer
component. Service for assistance
(at 1-877-4ABBOTT in the US).

10-62 CELL-DYN® 3700 System Operator’s Manual


9140320E — September 2004
Troubleshooting
Chapter 10

The MAIN MENU screen is not displayed after initialization.


Probable Cause Corrective Action
1. There is a floppy disk in the Data 1. If a disk is present, remove it and
Station disk drive. initialize the Data Station by turning
the power switch OFF and ON.
2. A file is missing or is incorrect on the 2. Call Abbott Diagnostics Customer
Data Station’s hard drive. Service for assistance
(at 1-877-4ABBOTT in the US).
3. There is a hardware or software 3. Call Abbott Diagnostics Customer
malfunction. Service for assistance
(at 1-877-4ABBOTT in the US).

The word Fault on the Analyzer Status Indicator Panel is illuminated in red.
Probable Cause Corrective Action
1. The Analyzer has detected a fault 1. From the first DIAGNOSTICS MENU
situation and has inhibited operation. screen, press [FAULT REPORT]. Print a
copy of the report and perform the
indicated corrective action. When the
action is completed, initialize the
Analyzer by pressing the
[INITIALIZATION] key on the second
DIAGNOSTICS MENU screen.
2. If the fault report does not indicate a
message or action, document the
situation and initialize the Analyzer by
pressing the [INITIALIZATION] key on the
second DIAGNOSTICS MENU screen.

CELL-DYN® 3700 System Operator’s Manual 10-63


9140320E — September 2004
Troubleshooting
Chapter 10

Instrument will not stop cycling.


Probable Cause Corrective Action
1. The touch plate is stuck or being held 1. Check the touch plate and remove any
down in some way. obstructions. Verify that it is not
sticking by pressing it several times.
2. Circuitry malfunction. 2. Call Abbott Diagnostics Customer
Service for assistance
(at 1-877-4ABBOTT in the US).

The Data Station keyboard and the soft keys are not operational.
Probable Cause Corrective Action
1. The computer is performing a function 1. No action required. Refer to the screen
that inhibits the keys. for the current Status Box message.
2. There is an incomplete operator entry. 2. Complete the operator entry or press
the Esc key on the keyboard.
3. A data transmission to the printer or 3. No action required. Refer to the screen
laboratory computer is in progress. for the current Status Box message.
4. Keyboard entry is not possible on the 4. No action required. Refer to the screen
displayed screen. for the current Status Box message.
5. Data Station computer, keyboard and/ 5. Initialize the Analyzer by pressing the
or circuitry malfunction. [INITIALIZATION] key on the second
DIAGNOSTICS MENU screen. If necessary,
call Abbott Diagnostics Customer
Service for assistance
(at 1-877-4ABBOTT in the US).

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9140320E — September 2004
Troubleshooting
Chapter 10

The Sample Loader does not power ON.


Probable Cause Corrective Action
1. Circuitry malfunction. 1. Call Abbott Diagnostics Customer
Service for assistance
(at 1-877-4ABBOTT in the US).

The Sample Loader beeps and the Start key is not illuminated.
Probable Cause Corrective Action
1. The cable that connects the Sample 1. Check that each end of the cable is
Loader to the Analyzer is loose or securely connected. If necessary,
disconnected. remove the cable and reconnect it.
Press the INT key on the Sample Loader
operation keyboard to initialize the
Sample Loader.
2. Circuitry malfunction. 2. Call Abbott Diagnostics Customer
Service for assistance
(at 1-877-4ABBOTT in the US).

Shear Valve problems.


Observable Condition: Corrective Action
The Shear Valve is leaking. Clean the Shear Valve (as directed in
Chapter 9).
Check the Shear Valve tubing for crimps.
Check the Shear Valve sections for
damage.
The Shear Valve does not rotate smoothly. Clean the Shear Valve (as directed in
Chapter 9).
Check Shear Valve sections for damage.
NOTE: After performing any maintenance or troubleshooting procedures, run at least 5
background counts and control material and ensure that the controls are in range.

CELL-DYN® 3700 System Operator’s Manual 10-65


9140320E — September 2004
Troubleshooting
Chapter 10

List of Messages and Fault Conditions


Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-68
Status Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-69
Auto-Sampler Busy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-69
Auto-Sampler cannot be started if the safety cover is off. . . . . . . . . . . . . . . . . . . . . . . . . .10-69
Auto-Sampler Emergency stop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-69
Auto-Sampler Initializing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-69
Auto-Sampler Off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-69
Auto-Sampler Pause . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-70
Auto-Sampler Ready . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-70
Bar Code flag not allowed to change unless Work List is purged . . . . . . . . . . . . . . . . . . .10-70
Change Sampler in Ready State Only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-70
Change Sampler when Auto-Sampler is not busy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-70
Change Specimen Type when Auto-Sampler is not busy . . . . . . . . . . . . . . . . . . . . . . . . . .10-71
Clearing Apertures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-71
Clearing Fault . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-71
Duplicate 4-digit Bar Code ID on the new line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-71
Duplicate Specimen ID on the new line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-71
Entering Standby. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-72
Entries making upper limit = lower limit were rejected . . . . . . . . . . . . . . . . . . . . . . . . . . .10-72
Extended Count . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-72
Initialized . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-72
Limits were changed to correct out-of-range values. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-73
Limits were exchanged to make upper > lower. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-73
Maintenance Due: name of component(s) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-73
No entry found . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-73
Ready . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-74
Samples Completed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-74
Selecting Open/Closed Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-74
Standby . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-74
Unpinching Valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-75
Westgard Warning — See Levey Jennings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-75

10-66 CELL-DYN® 3700 System Operator’s Manual


9140320C — November 2000
Troubleshooting
Chapter 10

General Fault Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-76


Auto-Sampler alarm, condition <x,x>; see DIAG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-76
Auto-Sampler command negatively acknowledged . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-76
Auto-Sampler consecutive data faults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-77
Auto-Sampler/Data fault . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-77
Bad checksum in nonvolatile RAM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-78
Bad monitor command . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-78
Blood in Auto-Sampler Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-78
Blood in Shear Valve Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-79
Data acquisition overlap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-79
Detergent empty: See Diluent, Lyse, Sheath, or Detergent empty . . . . . . . . . . . . . . . . . . 10-80
Diluent empty: See Diluent, Lyse, Sheath, or Detergent empty . . . . . . . . . . . . . . . . . . . . 10-80
Diluent, Lyse, Sheath, or Detergent empty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-80
External waste full. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-81
Flow sequence time out <x,x>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-81
Initalization Failed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-82
List mode data phase error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-82
Lyse empty: See Diluent, Lyse, Sheath, or Detergent empty . . . . . . . . . . . . . . . . . . . . . . . 10-80
Message acknowledgment time out . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-82
Message reception time out . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-83
Mixing Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-83
Not Ready: See Diag or Not Ready: See Special. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-84
Printer (Graphics or Ticket) unavailable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-84
RBC diluent syringe overpressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-85
RBC Metering fault — clog or flow error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-85
Sampling Error — Incomplete Aspiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-86
Shear Valve position fault . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-86
Sheath empty: See Diluent, Lyse, Sheath, or Detergent empty . . . . . . . . . . . . . . . . . . . . . 10-80
Uninitalized . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-87
Vacuum accumulator wet (1 or 2). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-87
WIC Metering fault — clog or flow error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-88
WOC Metering fault — flow error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-88

CELL-DYN® 3700 System Operator’s Manual 10-67


9140320C — November 2000
Troubleshooting
Chapter 10

Messages and Fault Conditions


Overview
Instrument messages may be displayed in the RUN screen Status
Box or on the Bulletin Line. Parameter Flagging messages are
discussed in Chapter 3: Principles of Operation, Subsection:
Operational Messages and Data Flagging.

Instrument messages fall into two categories:

1. Status Conditions inform the operator of the instrument’s


status or prompt the operator to take action relative to the
last operator entry.
2. General Fault Conditions indicate fault or error detection.

10-68 CELL-DYN® 3700 System Operator’s Manual


9140320D — June 2003
Troubleshooting
Chapter 10

Status Conditions

Auto-Sampler Busy
This message is displayed in the Bulletin Line.
Explanation/Action
An action was requested during Sample Loader operation and the Sample Loader
cannot perform it.
Press the Sample Loader PAUSE key before requesting the desired action.

Auto-Sampler cannot be started if the safety cover is off


This message is displayed in the Bulletin Line.
Explanation/Action
The Sample Loader START key was pressed and the safety interlock switch did not sense
that the Safety Cover was in place.
Replace the Safety Cover and then press the START key.

Auto-Sampler Emergency stop


This message is displayed in the Bulletin Line.
Explanation/Action
The Sample Loader E–STOP key was pressed during operation and the Sample Loader is
stopped.
Press the INT key (if the light on the key is blinking) to initialize the Sample Loader. If
the INT key light is not blinking, turn the Sample Loader power switch OFF and ON to
initialize. Press the [CLEAR FAULT] key on the Data Station to resume processing.

Auto-Sampler Initializing
This message is displayed in the Bulletin Line.
Explanation/Action
The Sample Loader hardware initialization cycle is in progress.
Wait for the cycle to be completed.

Auto-Sampler Off
This message is displayed in the Bulletin Line.
Explanation/Action
Power to the Sample Loader is turned OFF.
Turn ON the Power Switch and wait for the initialization cycle to be completed.

CELL-DYN® 3700 System Operator’s Manual 10-69


9140320C — November 2000
Troubleshooting
Chapter 10

Auto-Sampler Pause
This message is displayed in the Bulletin Line.
Explanation/Action
The Sample Loader PAUSE key was pressed during operation and therefore, operation is
suspended.
Press the Sample Loader START key to initiate processing.

Auto-Sampler Ready
This message is displayed in the Bulletin Line.
Explanation/Action
The Sample Loader initialization cycle is complete and samples may be processed.
Press the Sample Loader START key to initiate processing.

Bar Code flag not allowed to change unless Work List is purged
This message is displayed in the Bulletin Line.
Explanation/Action
The [BAR CODE ON] or [BAR CODE OFF] key was pressed and there is an existing Work List.
Delete all samples from the Work List before turning the bar code ON or OFF.

Change Sampler in Ready State Only


This message is displayed in the Bulletin Line.
Explanation/Action
The [CHANGE SAMPLER] key was pressed while the Analyzer was busy.
The [CHANGE SAMPLER] key can only be pressed when the Analyzer is in the READY state.

Change Sampler when Auto-Sampler is not busy


This message is displayed in the Bulletin Line.
Explanation/Action
The [CHANGE SAMPLER] key was pressed while the Sample Loader was busy.
Press the Sample Loader PAUSE key before pressing [CHANGE SAMPLER].

10-70 CELL-DYN® 3700 System Operator’s Manual


9140320C — November 2000
Troubleshooting
Chapter 10

Change Specimen Type when Auto-Sampler is not busy


This message is displayed in the Bulletin Line.
Explanation/Action
The [SPECIMEN TYPE] key was pressed while the Sample Loader was busy.
Press the Sample Loader PAUSE key before pressing [SPECIMEN TYPE].

Clearing Apertures
This message is displayed in the Status Box
Explanation/Action
The [CLEAR APERTURES] key was pressed or the instrument automatically performed the
Clear Apertures function in response to a clog or flow problem.
Wait until the READY message is displayed in the Status Box and repeat the sample.

Clearing Fault
This message is displayed in the Status Box
Explanation/Action
The [CLEAR FAULT] key was pressed after an operator correctable fault was detected.
Resume operation when READY is displayed in the Status Box and the word READY on
the Status Indicator Panel is illuminated in green.

Duplicate 4-digit Bar Code ID on the new line


This message is displayed in the Bulletin Line.
Explanation/Action
The Work List already contains the 4-digit bar code ID number that has been entered.
It is not possible to enter the same 4-digit bar code ID number twice in the Work List. If
appropriate, delete the previous entry and reenter the number.

Duplicate Specimen ID on the new line


This message is displayed in the Bulletin Line.
Explanation/Action
The Work List already contains the specimen ID number that has been entered.
It is not possible to enter the same specimen ID number twice in the Work List. If
appropriate, delete the previous entry and reenter the number.

CELL-DYN® 3700 System Operator’s Manual 10-71


9140320C — November 2000
Troubleshooting
Chapter 10

Entering Standby
This message is displayed in the Status Box
Explanation/Action
The instrument has been idle for four hours and therefore is automatically performing
a cleaning cycle before entering the STANDBY state. (The [DAILY SHUTDOWN] key also
initiates this message.)
When the cycle is complete, press [PRIME] or [RUN] to initiate the priming cycle and return
the instrument to the READY state. Resume operation when the cycle is complete.

Entries making upper limit = lower limit were rejected


This message is displayed in the Bulletin Line.
Explanation/Action
A mathematically incorrect limit was manually entered (using [RANGE ENTRY]) during
setup of a QC file. The currently entered numbers are not accepted and the previously
entered numbers for the parameter(s) remain.
Check to make sure the entered values are correct.

Extended Count
This message is displayed in the Status Box
Explanation/Action
A low value has been detected for the WBC and/or PLT count. The Analyzer is
automatically extending the cycle to count more cells. The Extended Count message is
displayed while running a specimen in the Auxiliary Mode.
Resume processing when the READY message is displayed in the Status Box.

Initialized
This message is displayed in the Status Box
Explanation/Action
The Analyzer hardware initialization is complete.
Press [PRIME] or [RUN] to initiate the priming cycle and return the instrument to the
READY state. Resume operation when the cycle is complete.

10-72 CELL-DYN® 3700 System Operator’s Manual


9140320C — November 2000
Troubleshooting
Chapter 10

Limits were changed to correct out-of-range values


This message is displayed in the Bulletin Line.
Explanation/Action
A mathematically incorrect limit was manually entered (using [MEANS/LIMITS]) during
setup of a QC file. The numbers entered generated a range containing a number greater
than the largest number allowed or less than zero. Therefore, the limits were
automatically changed.
Check to make sure the entered values are correct. If appropriate, recalculate the mean
and limits and enter correct values.

Limits were exchanged to make upper > lower


This message is displayed in the Bulletin Line.
Explanation/Action
A mathematically incorrect limit was manually entered (using [RANGE ENTRY]) during
setup of a QC file. The entered numbers caused the upper limit to be less than the
lower limit. Therefore, the numbers were automatically exchanged.
Check to make sure the entered values are correct. If appropriate, enter correct values.

Maintenance Due: name of components(s)


(This message is displayed in the Bulletin Line on the MAINTENANCE LOG screen only.)
Explanation/Action
The maintenance interval programmed in the Maintenance Log for the listed
component(s) is exceeded. Therefore, the maintenance needs to be done.
Perform the maintenance and indicate in the Maintenance Log that it is complete.

No entry found
This message is displayed in the Bulletin Line.
Explanation/Action
The number (Sequence Number or specimen ID number) entered on the DATA LOG
SEARCH screen is not present in the Data Log.
Check that the entry was correct. If appropriate, enter the correct number.

CELL-DYN® 3700 System Operator’s Manual 10-73


9140320C — November 2000
Troubleshooting
Chapter 10

Ready
This message is displayed in the Status Box
Explanation/Action
The Analyzer is ready to process samples.

Samples Completed
This message is displayed in the Bulletin Line.
Explanation/Action
The Sample Loader has completed processing samples in the End Rack and has stopped
automatically.

Selecting Open/Closed Mode


This message is displayed in the Status Box
Explanation/Action
The [CHANGE SAMPLER] key was pressed and the Analyzer is changing to the selected
mode of operation.
Resume processing when the READY message is displayed in the Status Box.

Standby
This message is displayed in the Status Box
Explanation/Action
The instrument has entered the STANDBY state.
Press [PRIME] or [RUN] to initiate the priming cycle and return the instrument to the
READY state. Resume operation when the cycle is complete.

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9140320C — November 2000
Troubleshooting
Chapter 10

Unpinching Valves
This message is displayed in the Status Box
Explanation/Action
The Analyzer was idle for a predetermined time period and therefore the valves are
being exercised to be sure that tubing is not pinched shut.
Resume processing when the READY message is displayed in the Status Box.

Westgard Warning — See Levey Jennings


(This message is displayed in the Bulletin Line on the VIEW QC LOG screen only.)
Explanation/Action
The Westgard Rules were selected during set up of the QC file and the data in the file
has violated one or more of the selected rules.
Review the data in the QC file and take appropriate action.

CELL-DYN® 3700 System Operator’s Manual 10-75


9140320C — November 2000
Troubleshooting
Chapter 10

General Fault Conditions


Information for each message is listed in order from the most
likely cause of the message to the least likely cause of the message.
Therefore, always troubleshoot a problem in this order. If a
problem cannot be resolved by the corrective action indicated in
this table, call Abbott Diagnostics Customer Service for assistance
(at 1-877-4ABBOTT in the US).

Auto-Sampler alarm, condition <x,x>; see DIAG


This message is displayed in the Bulletin Line.
NOTE: The characters in the brackets identify the condition.
Probable Cause Corrective Action
1. The Sample Loader detected a 1. From the first DIAGNOSTICS MENU screen,
hardware fault and ceased operation. press [FAULT REPORT] followed by
[PRINT] to obtain a printout describing
the problem. Initialize the Sample Loader
by turning the power OFF and then ON.
Samples may be processed if the fault
does not recur.
CAUTION: If the Sample Loader needle does not retract properly from
the specimen vacutainer, discard this specimen, collect a new one, and
repeat the test to ensure accurate patient results.

Auto-Sampler command negatively acknowledged


This message is displayed in the Bulletin Line.
Probable Cause Corrective Action
1. The Sample Loader did not respond to 1. Ensure that the Sample Loader power
an Analyzer command. cord is connected to the Sample Loader
and that the cord is connected to the
power outlet. Initialize the Sample
Loader by pressing the INT key on the
Sample Loader operation keyboard.
Check the connections of the cable that
connects the Sample Loader to the
Analyzer. If necessary, secure the
connections. Initialize the Sample
Loader by pressing the INT key on the
Sample Loader operation keyboard.
2. Circuitry malfunction. 2. Call Abbott Diagnostics Customer
Service for assistance
(at 1-877-4ABBOTT in the US).

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9140320E — September 2004
Troubleshooting
Chapter 10

Auto-Sampler consecutive data faults


This message is displayed in the Bulletin Line.
Probable Cause Corrective Action
1. During sample processing, four 1. Correct the situation on the Analyzer as
consecutive incomplete aspiration or follows:
metering faults were detected and the
•Check the appropriate tubing for a
Sample Loader halted.
plug or pinch.
•Press [CLEAR APERTURES] to clear the
apertures.
•Clean the Sample Loader needle. (If
necessary, refer to the instructions
given in Chapter 9.)
2. Press the [CLEAR FAULTS] key displayed
on the RUN screen. The Sample Loader
automatically resumes processing.

Auto-Sampler/Data fault
This message is displayed in the Bulletin Line.
Probable Cause Corrective Action
1. Four sequential clog or flow messages 1. Follow the instructions given in
occurred during Sample Loader Symptom Identification and
operation. Resolution within this chapter for
troubleshooting clog, flow, or
incomplete aspiration messages.
2. Four sequential incomplete aspiration
messages occurred during Sample
Loader operation.

CELL-DYN® 3700 System Operator’s Manual 10-77


9140320C — November 2000
Troubleshooting
Chapter 10

Bad checksum in nonvolatile RAM


This message is displayed in the Bulletin Line.
Probable Cause Corrective Action
1. When the system was powered ON, the 1. Turn the power OFF to the Data Station
Analyzer did not transmit the correct and Analyzer. Turn ON the power to the
message to the Data Station. Analyzer, then turn ON the power to the
Data Station. If the fault recurs, call
Abbott Diagnostics Customer Service
for assistance (at 1-877-4ABBOTT in
the US).

Bad monitor command


This message is displayed in the Bulletin Line.
Probable Cause Corrective Action
1. The Analyzer did not initialize properly 1. Initialize the Analyzer by pressing the
when the system was turned ON. [INITIALIZATION] key on the second
DIAGNOSTICS MENU screen. If the fault
recurs, call Abbott Diagnostics
Customer Service for assistance
(at 1-877-4ABBOTT in the US).

Blood in Auto-Sampler Line


This message is displayed in the Bulletin Line.
Probable Cause Corrective Action
1. At the end of the count cycle, the 1. Check the sample line to see if it
instrument detects blood in the sample contains blood. If it does, clean or
line that runs from the top of the replace the Sample Loader needle or
Sample Loader tower to the Shear sample line.
Valve. When this occurs, the system
2. Check for a crimp in the sample
automatically cleans the needle and the
aspiration tubing between the Sample
sample line. If blood is still present in
Loader and the Analyzer.
the line, the Analyzer halts.
NOTE: If necessary, samples can be processed in the Open Mode, as it is not affected
by this problem. To run samples in the Open Mode, first initialize the system
as directed in the initialization procedure provided in Troubleshooting
Procedures within this chapter. When initialization is complete, the Open
Mode is automatically selected and samples can then be processed.

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9140320E — September 2004
Troubleshooting
Chapter 10

Blood in Shear Valve Line


This message is displayed in the Bulletin Line.
Probable Cause Corrective Action
1. At the end of the count cycle, the 1. Clean the Shear Valve (as directed in
instrument detects blood at one of the Chapter 9).
sensors near the Shear Valve. When
this occurs, the system automatically
cleans the needle and the Sample
Aspiration Line. If blood is still present
in the line, the Analyzer halts.

Data acquisition overlap


This message is displayed in the Bulletin Line.
Probable Cause Corrective Action
1. The timing of communication between 1. Document what was happening when
the Analyzer and the Data Station is the message was displayed and report
incorrect. Current specimen data is the problem to Abbott Diagnostics
received while previous specimen data Customer Service. Initialize the
is being processed. Analyzer by pressing the
[INITIALIZATION] key on the second
DIAGNOSTICS MENU screen. Resume
processing if the fault does not recur.
NOTE: The error may occur when several tasks are requested in rapid sequence. For
example, print data log, transmit result, sample processing, print ticket,
print report, etc.

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9140320E — September 2004
Troubleshooting
Chapter 10

Diluent, Lyse, Sheath, or Detergent empty


This message is displayed in the Status Box and Bulletin Line.
Probable Cause Corrective Action
1. Container is empty. 1. Install a new container of reagent and
then press [CLEAR FAULTS]. Run 5 or more
background counts and review results.
NOTE:Do not pour any remaining
reagent into the new container.
2. Reagent inlet tubing is crimped or 2. Inspect the inlet tubing to ensure it is not
obstructed. crimped and/or remove any obstruction.
Run 5 or more background counts and
review results.
3. Reagent line is not on the bottom of 3. Ensure that the line is properly inserted
the container. in the container and the sinker is on the
bottom of the container. Run 5 or more
background counts and review results.
4. An incorrect reagent or a 4. Check the label on the reagent container
nonconductive liquid is connected to to be sure the correct reagent is installed.
the inlet tube. Trace the line to the inlet connector and
ensure that it is connected to the correct
one. Check the connection to be sure it is
secure and then press [CLEAR FAULTS].
Run 5 or more background counts and
review results.
5. Circuitry malfunction. 5. Call Abbott Diagnostics Customer
Service for assistance
(at 1-877-4ABBOTT in the US).

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9140320E — September 2004
Troubleshooting
Chapter 10

External waste full


This message is displayed in the Status Box.
Probable Cause Corrective Action
1. Waste container full. 1. Empty the waste container and/or
replace it. Press [CLEAR FAULTS] to
resume operation.
2. Waste sensor connector is loose or 2. Reconnect the waste sensor connector
disconnected. and then press [CLEAR FAULTS].
3. Shorted wire(s) or electrode(s) on the 3. Inspect wires and electrodes and call
waste cap. Abbott Diagnostics Customer Service
for assistance (at 1-877-4ABBOTT in
the US).
4. Circuitry malfunction. 4. Call Abbott Diagnostics Customer
Service for assistance
(at 1-877-4ABBOTT in the US).

Flow sequence time out <x,x>


This message is displayed in the Bulletin Line.
NOTE: Characters in the brackets identify the problem flow sequence number and
flow sequence name.
Probable Cause Corrective Action
1. An internal Analyzer flow sequence was 1. Record the characters in the brackets.
not completed in the allotted time. Turn the power OFF to the Data Station
and Analyzer. Turn ON the power to the
Analyzer, then turn ON the power to the
Data Station. If the fault recurs, call
Abbott Diagnostics Customer Service
for assistance (at 1-877-4ABBOTT in
the US).

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9140320E — September 2004
Troubleshooting
Chapter 10

Initialization Failed
This message is displayed at the bottom of the screen. (MAIN MENU is not displayed.)
Probable Cause Corrective Action
1. The Data Station was unable to 1. Initialize the Analyzer by following the
initialize. The CELL-DYN software does instructions in Power OFF Procedure
not display the MAIN MENU screen. and Power ON Procedure in
Troubleshooting Procedures within this
chapter. If the Data Station does not
initialize, press the Print Screen key on
the computer keyboard to document
any screen messages and call Abbott
Diagnostics Customer Service for
assistance (at 1-877-4ABBOTT in the
US).

List mode data phase error


This message is displayed in the Bulletin Line.
Probable Cause Corrective Action
1. The order of the data received by the 1. Call Abbott Diagnostics Customer
Data Station during a measurement Service for assistance
was incorrect. (at 1-877-4ABBOTT in the US).

Message acknowledgment time out


This message is displayed in the Bulletin Line.
Probable Cause Corrective Action
1. Communication between the Analyzer 1. Initialize the Analyzer by pressing the
and the Data Station did not occur [INITIALIZATION] key on the second
when expected. DIAGNOSTICS MENU screen. If the fault
recurs, call Abbott Diagnostics
Customer Service for assistance
(at 1-877-4ABBOTT in the US).

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9140320E — September 2004
Troubleshooting
Chapter 10

Message reception time out


This message is displayed in the Bulletin Line.
Probable Cause Corrective Action
1. Communication between the Analyzer 1. Make sure the cable between the
and the Data Station did not occur analyzer and Data Station is securely
when expected. connected.
2. Initialize the Analyzer by pressing the
[INITIALIZATION] key on the second
DIAGNOSTICS MENU screen. If the fault
recurs, call Abbott Diagnostics
Customer Service for assistance
(at 1-877-4ABBOTT in the US).

Mixing Error
This message is displayed in the Bulletin Line.
MIX ERROR is displayed on the RUN screen to the right of the MCH result.
“MIXING ERR” is printed on the graphics report. A mixing error is always accompa-
nied by a sampling error; therefore, “SAMPLING ERR” is printed on all reports.
Probable Cause Corrective Action
1. The Sample Loader mixing head(s) 1. Check to be sure that the sample tube
detected resistance when attempting to can spin freely in the Sample Loader
mix a sample. Therefore, no sample rack. If necessary, remove excess labels
was aspirated and results appear to be a or obstructions. Repeat the sample.
background count.
2. One or both mixer motors is binding 2. Call Abbott Diagnostics Customer
and generating resistance. Service for assistance
(at 1-877-4ABBOTT in the US).

CELL-DYN® 3700 System Operator’s Manual 10-83


9140320E — September 2004
Troubleshooting
Chapter 10

Not Ready: See Diag or Not Ready: See Special


This message is displayed in the Status Box.
The word FAULT on the Analyzer Status Indicator Panel is illuminated in red.
Probable Cause Corrective Action
1. A situation that prevents the Ready state 1. From the first DIAGNOSTICS MENU
has been detected. See the DIAGNOSTICS screen, press [FAULT REPORT] followed
MENU screen or the SPECIAL PROTOCOLS by [PRINT] to obtain a printout
MENU screen, whichever is indicated, for describing the problem. Refer to the
more information. appropriate table for corrective action.
2. A diagnostic test was run using one of 2. The instrument must be initialized
the DIAGNOSTICS MENU screen keys. when the diagnostic test in progress is
complete. Initialize the Analyzer by
pressing the [INITIALIZATION] key on the
second DIAGNOSTICS MENU screen.
3. A Special Protocols procedure is in 3. Check the SPECIAL PROTOCOLS MENU
progress. screen and perform the action
necessary to complete the procedure.
4. System malfunction. 4. Call Abbott Diagnostics Customer
Service for assistance
(at 1-877-4ABBOTT in the US).

Printer (Graphics or Ticket) unavailable


This message is displayed in the Bulletin Line.
Probable Cause Corrective Action
1. The print buffer (the memory area 1. Press the [STOP PRINTING] key on the
where the material is stored while CUSTOMIZE PRINTED REPORT screen for
awaiting printing) is full. the appropriate printer.
2. The printer is turned OFF. 2. Turn the printer power switch ON.
3. The printer is not on-line. 3. Check that the printer “on-line”
indicator is illuminated. If necessary,
refer to the printer manual for assistance.
4. The printer is disconnected or the 4. Check the printer cable connection on
connection is loose. the back of the Data Station and on the
back of the printer. If necessary, secure
the connections. Press [PRINT REPORT].
If the message is still displayed, turn
the printer power switch OFF and ON
to reset the printer.

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9140320E — September 2004
Troubleshooting
Chapter 10

RBC diluent syringe overpressure


This message is displayed in the Status Box.
Probable Cause Corrective Action
1. The Shear Valve did not rotate 1. Clean the Shear Valve (as directed in
completely or in the time allotted. Chapter 9).
2. The center section of the Shear Valve is 2. Verify that the center section of the
installed backwards. Shear Valve is installed correctly.
3. Tubing connected to RBC/PLT Diluent 3. Check tubing connected to the RBC/
Syringe is twisted or crimped. PLT Diluent syringe.
4. Excessive pressure was detected during 4. a. Remove the RBC diluent syringe
the up-stroke of the RBC Diluent from its bracket (make sure syringe
Syringe. stays connected to the luer fitting) to
release pressure.
b. Cycle power to Initialize.
c. DO NOT press RUN Key.
d. Go directly to Special Protocols and
select “Clean Shear Valve,” then
“Reinstall Shear Valve.”
e. Run Background.
5. If the problem persists, Call Abbott
Diagnostics Customer Service for
assistance (at 1-877-4ABBOTT in the
US).

RBC Metering fault — clog or flow error


This message is displayed in the Bulletin Line.
RBC CLOG or RBC FLOW ERROR is displayed on the RUN screen to the right of the RDW
result. “RBC CLOG” or “RBC FLOW” is printed on the graphics report.
Results for RBC, PLT and related parameters are suppressed.
Probable Cause Corrective Action
1. The timing for the RBC/PLT 1. Repeat the sample. If the problem was
Metering was outside acceptable limits. caused by debris in the aperture, the
automatic clearing cycle will have
corrected it.
2. Clean the RBC/PLT aperture as directed
Chapter 9.
3. Ensure that the detergent reagent is
properly connected to the inlet
connector.
NOTE: The Analyzer automatically clears the RBC/PLT aperture after a metering
fault is detected. CLEARING APERTURES is displayed in the Status Box.

CELL-DYN® 3700 System Operator’s Manual 10-85


9140320E — September 2004
Troubleshooting
Chapter 10

Sampling Error — Incomplete Aspiration


This message is displayed in the Bulletin Line.
SAMPLING ERROR is displayed on the RUN screen to the right of the MCHC result.
“SAMPLING ERR” is printed on all reports.
Probable Cause Corrective Action
1. The blood sensors did not detect a 1. Check the sample tube to be sure it
sufficient amount of sample on either contains a sufficient quantity of blood.
side of the Shear Valve after aspiration.
2. Clean the Open Sample Aspiration
Probe or the Closed Mode needle (CS
or SL) as directed in Chapter 9 to
remove any obstructions.
3. Change the Sample Aspiration
Peristaltic Pump Tubing as directed in
Chapter 9.
4. Clean the Shear Valve as directed in
Chapter 9.
5. Call Abbott Diagnostics Customer
Service for assistance
(at 1-877-4ABBOTT in the US).
NOTE: Samples with RBC results below 1.00 x 106/µL may generate this fault
because the sample is translucent. The fault may also occur when running
diluted samples. Observe the Shear Valve. If there is a minimum of one inch
of blood on both sides of the valve when it rotates, results should be correct.

Shear Valve position fault


This message is displayed in the Bulletin Line.
Probable Cause Corrective Action
1. The Shear Valve did not rotate properly 1. Clean the Shear Valve (as directed in
or in the allotted time. Chapter 9).

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9140320E — September 2004
Troubleshooting
Chapter 10

Uninitialized
This message is displayed in the Status Box.
Probable Cause Corrective Action
1. Data Station has power but the 1. Ensure that the Analyzer power cord is
Analyzer is not responding. connected to the Analyzer and that the
cord is connected to the power outlet.
Initialize the Analyzer by pressing the
[INITIALIZATION] key on the second
DIAGNOSTICS MENU screen.
2. Communication malfunction between 2. Check the cable that connects the
the Analyzer and Data Station. Analyzer to the Data Station. If
necessary, secure the connections.
Initialize the Analyzer by pressing the
[INITIALIZATION] key on the second
DIAGNOSTICS MENU screen.

Vacuum accumulator wet (1 or 2)


This message is displayed in the Bulletin Line.
Probable Cause Corrective Action
1. The internal vacuum accumulator has 1. From the second DIAGNOSTICS MENU
filled with liquid beyond allowable screen, press the [DRAIN ACCUMULAT]
limits. key. When the cycle is complete,
initialize the Analyzer by pressing the
[INITIALIZATION] key on the second
DIAGNOSTICS MENU screen. If the fault
recurs, repeat this action. If the fault
persists, call Abbott Diagnostics
Customer Service for assistance
(at 1-877-4ABBOTT in the US).

CELL-DYN® 3700 System Operator’s Manual 10-87


9140320E — September 2004
Troubleshooting
Chapter 10

WIC Metering fault — clog or flow error


This message is displayed in the Bulletin Line.
WIC CLOG or WIC FLOW ERROR is displayed on the RUN screen to the right of the LYM
results. “WIC CLOG” or “WIC FLOW” is printed on the graphics report.
Results for WBC and Differential are suppressed.
Probable Cause Corrective Action
1. The timing for the WIC metering was 1. Repeat the sample. If the problem was
outside acceptable limits. caused by debris in the aperture, the
automatic clearing cycle will have
corrected it.
2. Clean the WIC Aperture Plate as
directed in Chapter 9.
3. Ensure that the detergent reagent is
properly connected to the inlet
connector.
4. Run several background counts.
NOTE: The Analyzer automatically clears the WIC aperture after a metering fault is
detected. CLEARING APERTURES is displayed in the Status Box.

WOC Metering fault — flow error


This message is displayed in the Bulletin Line.
WOC FLOW ERROR is displayed on the RUN screen to the right of the NEU results.
“WOC FLOW” is printed on the graphics report. Results for WBC and Differential are
suppressed.
Probable Cause Corrective Action
1. An increasing WOC count rate was 1. Repeat the sample.
detected in the WOC flow cell during
the WOC measurement.
2. Replace the WOC Transfer Peristaltic
Pump Tubing as directed in Chapter 9.
3. Clean the WOC Metering Syringe as
directed in Chapter 9.

10-88 CELL-DYN® 3700 System Operator’s Manual


9140320C — November 2000
Chapter 11 Printers

Overview

The CELL-DYN 3700 system is configured with a color Graphics


Printer (known in this manual as the Graphics Printer). The
printer is set up to print reports, including complete graphic
information, on 8.5" X 11" paper. The printer may be set up to
print graphic information in color or black only.

If ticket printing is desired for the CELL-DYN 3700, a second


printer (known as the Ticket Printer) can also be connected to the
system at the same time as the Graphics Printer. Results are
automatically printed at the completion of each run cycle or are
printed on command by the operator. The Ticket Printer can be
used to print reports with graphic information in black only, but
the connection to the Data Station must be changed.

IMPORTANT: The CELL-DYN 3700 System has been


configured for and tested with specific printers, such as
the printer shipped with the analyzer. For additional
information about specific printer capability with the
CELL-DYN 3700 System, US Customers, please contact the
Customer Service Center at 1-877-4ABBOTT
(1-877-422-2688). Customers outside the US should
contact your local Customer Service representative. Use of
printers other than those recommended by Abbott
Laboratories may lead to erroneous printer functionality.

Refer to Chapter 2: Installation; Subsection: Printer Installation


for instructions on installing both printers.

Complete directions for customizing the printout type and format


are given in Chapter 5: Operating Instructions, Subsection: Set
Up Instructions.

CELL-DYN® 3700 System Operator’s Manual 11-1


9140320F — April 2007
Printers
Overview Chapter 11

NOTES

11-2 CELL-DYN® 3700 System Operator’s Manual


9140320F — April 2007
Chapter 11 Printers

Routine Operation

Graphics Printer
The CELL-DYN 3700 software automatically controls and adjusts
most print conditions, including page width. If printing is not
what you expect, refer to the printer manual for guidance in
making adjustments. If you have additional questions or
experience any problems, call Abbott Diagnostics Customer
Service for assistance.

Ticket Printer
For detailed information about loading continuous-feed tickets or
paper and changing the ribbon in the Ticket Printer, refer to the
manuals that accompany the printer. In particular, note the
important safety instructions. This section gives information
about ticket printing and instructions for loading individual pre-
printed tickets in the Ticket Printer.

The Ticket Printer can be used to print a complete graphics report


on continuous tractor-feed paper or to print result data on blank
or pre-printed tickets. (Blank tickets are available in continuous
tractor-feed sheets. Pre-printed tickets are loaded individually.) To
print the graphics report, the printer cable must be connected to
the Graphics Printer connector on the back of the Data Station.

Printing Tickets
To print tickets, the printer cable must be connected to the Ticket
Printer connector on the back of the Data Station. (See Figure 2.5
for the location of these connectors.) Refer to Chapter 5:
Operating Instructions, Subsection: Set Up Instructions for
instructions for customizing either type of printout.

Loading Individual Tickets


Instructions are given for loading individual tickets. If fan-fold,
continuous-feed tickets are used, they should be loaded as
directed in the printer manual for tractor-feed paper.

1. Be sure that the printer is turned ON and the printer cable is


connected to the Ticket Printer Connector on the back of the
Analyzer. If the connection is incorrect, turn the Analyzer
power OFF, change the position of the cable and turn the
power back ON.

CELL-DYN® 3700 System Operator’s Manual 11-3


9140320F — April 2007
Printers
Routine Operation Chapter 11

2. Set the ribbon cartridge headgap lever to adjust for the


thickness of the tickets. Refer to the printer manual for the
location of the headgap lever and for detailed instructions.
3. Move the paper selection lever to the rear position to select
single-feed paper.
4. Open the access cover and be sure the guide wire on the
paper separator is pushed back into the locked position.
5. Raise the separator to its upright position.
6. Place a ticket on the paper separator and adjust the guides so
that they barely touch the edges of the ticket.
7. Pull the bail lever forward. The ticket will automatically feed
into place. Release the paper bail lever.
8. Be sure the printer is deselected (Sel indicator is not
illuminated) and set the Top of Form by pressing and
holding the TOF/Quiet key and pressing the Form Feed key
to move the ticket up or pressing the Line Feed key to move
the ticket down. (The ticket moves in very fine increments so
it can be precisely positioned.)
NOTE: The ticket will only move down to a certain point
to prevent potential ticket jams. Do not move the top of
the page below the paper bail.

9. Position the ticket so that the lower red line on the paper
shield (located between the print head and the paper) is
positioned where the first line of printing should occur.
NOTE: When the Top of Form is set, the position is
retained in the printer memory until it is reset.

10. Press the Sel key to select the printer. The printer is now
ready to print.

11-4 CELL-DYN® 3700 System Operator’s Manual


9140320F — April 2007
Printers
Chapter 11 Maintenance and Troubleshooting

Maintenance and Troubleshooting

This section gives a brief overview of printer maintenance and


troubleshooting. Instructions for installation are given in
Chapter 2: Installation; Subsection: Printer Installation. For a
detailed description of the printer components and instructions
on changing the ink cartridges or ribbon, and loading paper, refer
to the manuals that accompany the printer.

Cleaning
Every six months (or after about 300 hours of operation) turn the
printer OFF and use a clean, dry cloth to dust the area around the
carriage shaft and platen. Be sure to remove any loose particles of
paper. Do not use solvents or strong detergents on the cabinet.

Troubleshooting
Refer to the printer manuals for a list of the most common printer
problems and how to solve them. If the problem is not resolved,
contact the Abbott Diagnostics Customer Service Center for
assistance.

If, during routine system operation, the message PRINTER


UNAVAILABLE is displayed on the bulletin line, check to see that
the printer cable is securely connected to the Data Station, the
printer power switch is turned ON, and that the printer status is
on-line. Press the [PRINT] key. If the message is still displayed, turn
the printer power OFF, wait about five seconds, turn the power
ON again and press the [PRINT] key. If the message is still displayed,
there may be an internal printer error. Contact Abbott Diagnostics
Customer Service for assistance.

CELL-DYN® 3700 System Operator’s Manual 11-5


9140320F — April 2007
Printers
Maintenance and Troubleshooting Chapter 11

NOTES

11-6 CELL-DYN® 3700 System Operator’s Manual


9140320F — April 2007
Chapter 12 Sample Loader
Sample Loader

Overview

The Sample Loader for the CELL-DYN 3700SL System is an


automated microprocessor-based sample-handling system designed
to fit directly in front of the Analyzer. (See the following figure.)
The Analyzer communicates electronically with the Sample Loader
and vice versa. The Sample Loader delivers blood samples (and
their identification information) to the CELL-DYN 3700SL System
for analysis. The sample tubes are transported in racks that keep
the tubes in an upright position. The Sample Loader processes up
to 100 samples at a time with or without bar code labels.

Figure 12.1: Analyzer with Sample Loader

CELL-DYN® 3700 System Operator’s Manual 12-1


9140320E — September 2004
Sample Loader
Overview Chapter 12

When the START key on the Sample Loader is pressed, the tube
racks advance to move each tube through the three processing
stations located in the base of the tower:

• Station 1: Pre-Mixing. The tube is sensed and the


sample is pre-mixed by
counter-rotation for
approximately 30 seconds.*
• Station 2: Mixing. The bar code label is read (if
present) and the sample is
mixed again for approximately
30 seconds.*
• Station 3: Vent/Aspiration. The plunger positions the tube,
the tube stopper is punctured,
the tube is vented, and the
sample is aspirated.
* The first tube in a series skips Station 1 and is advanced to
Station 2 for complete mixing (for approximately 60 seconds).

Tower Station 2:
Station 3: Mixing Station 1:
Vent/Aspiration Pre-Mixing
Needle

Front
Figure 12.2: Rack Movement - Top View

As illustrated in the preceding figure, the tube racks move from


the right side of the tray, through the three tower stations, and
over to the left side of the tray. Consequently, the rack on the right
side at the back of the tray is the first to be processed. When the
last tube in this rack is at Station 2, the next rack is moved into
position for processing. Racks are continuously moved to ensure
that tubes are always present in the three tower stations.
Fluids travel between the Analyzer and the Sample Loader through
four tubes. These tubes carry blood and waste to the Analyzer and
diluent to the Sample Loader for cleaning. A cable is connected to
the Analyzer to provide bidirectional communication.

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Sample Loader
Chapter 12 Bar Code Labels

Bar Code Labels

CELL-DYN Bar Code Labels


CELL-DYN 4-digit bar code labels are available for the Sample
Loader. These labels may be used for positive specimen
identification when laboratory-generated bar code labels are
unavailable.

CELL-DYN Q Labels
Special bar code labels are available to identify QC specimens.
These “Q” labels (numbers Q1 – Q20) automatically select QC
files 1 to 20 and, therefore, should be used to process only QC
specimens.

Bar Code Label Placement


All labels should be placed on the tubes securely and without
flaps or edges sticking out. Labels should not cover the cap (high
collar) or the bottom of the tube (tail). (See the following figure.)
Excessive numbers of labels may prevent tubes from mixing properly.

Top Surface PROPERLY LABELED TUBES


Should Be
Dry

Exposed
Bar Bottom
Clear Coded
Tape Label
High
IMPROPERLY LABELED TUBES Collar

16.5 mm Dia.
Width Limit for Flap
Multiple
Labels
Edges
Peeled
Loose

Tail

Figure 12.3: Tube Labeling Requirements

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Sample Loader
Bar Code Labels Chapter 12

The bar code label should be placed on the tube just below the
stopper, with the bars perpendicular to the length of the tube, so
that the entire bar code can be viewed through the slot in the rack
as the tube rotates. See the preceding figure for proper placement.

NOTE: Refer to Appendix A: Bar Codes for complete


information on Bar Codes, Check Digits, and
specifications.

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Chapter 12 Sample Loader

Sample Loader Components

The Sample Loader consists of a Main Module and a Tower Unit, as


depicted in the following figure.

Tower Unit

Safety Cover

Operation Keyboard

Power ON/OFF
Switch

Tube Racks

Main Module

Figure 12.4: Sample Loader

Main Module
The Main Module contains:
• Power ON/OFF Switch
• Operation Keyboard
• Safety Cover
• Tray to hold the Tube Racks

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Sample Loader
Sample Loader Components Chapter 12

Sample Loader Operation Keyboard Keys


The operator controls the Sample Loader using the Primary Keys on
the Operation Keyboard. The Manual Keys are used by authorized
Abbott service representatives. The operator may, in the course of
troubleshooting, be directed by an Abbott representative to access
the Manual Keys.

Phillips screws Plexiglass cover

Manual
Operation
Keys

Primary
Keys

Figure 12.5: Operation Keyboard

Primary Keys
The red and yellow Primary Keys on the Sample Loader are:

INIT— (Initialize.) Activates the initialization cycle.


(Yellow)
START— Initiates processing whenever the
(Yellow) CELL-DYN 3700SL System is in the READY state.

PAUSE— Pauses the processing after the current cycle is


(Yellow) completed. This key can be used any time the
processing needs to be interrupted.
REPEAT— Does not function.
(Yellow)
RESET— Resets the Sample Loader and activates the INT
(Red) key, usually in conjunction with an activated
alarm situation.
E/STOP— (Emergency Stop.) Terminates the processing
(Red) immediately. Any sample being processed when
this key is pressed must be repeated.

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Sample Loader
Chapter 12 Sample Loader Components

Tower Unit
The Tower Unit illustrated in the following figure contains the
following:
• Two Mixing Heads
• Vent/Aspiration Needle and Vent/Aspiration Needle Wash
Block
• Tube Detector
• Vial Positioning Mechanism (referred to as the Plunger)
• Bar Code Reader Window
NOTE: A detailed functional description of all
components is given in Operating Principles, Functional
Description within this chapter.

Blood Sensor

Station 2:
Mixing Head 2
(Mixing)

Station 3: Station 1:
Needle Mixing Head 1
(Vent/Aspiration) (Pre-Mixing)

Wash Block Tube Detector


Bar Code Reader
Window Cover Plate Bar Code
Reader Window
Vial Positioning
Mechanism

Figure 12.6: Tower Stations

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Sample Loader Components Chapter 12

NOTES

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Chapter 12 Sample Loader

Operating Principles

Functional Description
The Sample Loader is attached to the Analyzer as shown in
Figure 12.1, Analyzer with Sample Loader.

Three stations located at the base of the Sample Loader Tower are
used to pre-mix, mix, and vent/aspirate each specimen tube. (See
Figure 12.6, Tower Stations.) The mixing process is performed by
counter-rotation of the tubes at the first two stations. A Mixing
Head extends to pre-mix the specimen at Station 1 for
approximately 30 seconds. A second Mixing Head extends to mix
the specimen for approximately 30 seconds more at Station 2. (The
first tube in a series skips Station 1 and is advanced to Station 2 for
complete mixing for approximately 60 seconds.) A Mixing Monitor
checks to ensure that both mixers are operating properly. If the
tube cannot spin properly, a MIX ERROR is displayed. The Vent/
Aspiration Needle then extends to puncture the tube stopper, vent
the tube, and aspirate the mixed specimen at Station 3.

When the tube is at the Vent/Aspiration Station, a Plunger (a vial


positioning mechanism) positions the tube vertically in the rack
and holds it while the tube is vented and the sample aspirated.
This enables the tube stopper to be pierced in the center and the
rack to accommodate tubes with varying numbers of labels.

Ten Tube Racks must be in place for Sample Loader operation. The
End Rack is marked with black dots on top and a black mark on the
left end of the rack. (See the following figure.) The End Rack is used
to indicate the last rack of a specific run. The Sample Loader
automatically stops after the last tube in the End Rack is processed.

A clear plexiglass Safety Cover fits on top of the main Sample


Loader Module. It covers the processing stations to prevent
aerosol contamination, and to prevent operator exposure to the
bar code reader laser and the needle while the Sample Loader is
processing specimens.

NOTE: The Sample Loader has an Interlock Switch that


prevents operation when the Safety Cover is not in place.
The operator must press the PAUSE key and wait for the
Sample Loader to stop processing before lifting or
removing the cover. Lifting the cover while the Sample
Loader is operating causes an immediate Emergency Stop
condition.

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Sample Loader
Operating Principles Chapter 12

CAUTION: If a Sample Loader fault occurs that


necessitates initialization of the Sample Loader, remove all
samples that have been processed before restarting the
Sample Loader. If these samples are not removed,
misidentification of the remaining samples will occur.

When the Sample Loader sensors detect the End Rack, the Sample
Loader emits audible beeps for three seconds to alert the operator.
The message SAMPLES COMPLETED appears in the Data Station
Bulletin Line. If continuous processing is desired, an unmarked
rack should be substituted for the End Rack.

Black End Rack Visual Indicator Label


Bar Coded (END RACK ONLY)
Position Rack ID
ID Label Number
Label

Tube
Rack

Bar Coded Rack


ID Label

Black End Rack Sensor Label


Orient Numbered End (END RACK ONLY)
DOWNWARD

Figure 12.7: Tube Racks

The tube racks are identified by a bar code label which must be in
place between the first and second tube position. (See the
preceding figure.)

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Sample Loader
Chapter 12 Operating Principles
NOTE: The Tube Rack Bar Code Label is read when the
tube in the first position is moved to the vent/aspirate
station. If there is no bar code label on the rack or the label
is unreadable, the Sample Loader stops, and the message:
AUTO SAMPLER DATA FAULT is displayed on the
Bulletin Line. Bar code labels on tube racks are essential
for proper Sample Loader operation. They must be placed
on racks between tube positions 1 and 2, even if bar code
labels on specimens are not used. For more information,
refer to Chapter 2: Installation.

The Tube Rack Bar Code Label identifies each rack by number and
is read by the Bar Code Reader. Each individual tube position has
a unique bar code. The system tracks the rack number and tube
position for each specimen placed in the rack.

The Sample Loader provides positive specimen identification with


a Laser Bar Code Reader at Station 2. As each tube reaches Station
2, the tube rotates and the bar code reader turns on to read the bar
code label on the tube. If no bar code label is present or the label
is unreadable, the sample will be identified on the Data Station
RUN screen and in the Data Log by the rack number and tube
position (in the format RxTx).

The use of bar code labels is recommended for positive sample


identification. Operation of the Sample Loader with non-bar-
coded samples is allowed, but the operator must then pay careful
attention to the rack number and tube position of each sample for
correct identification.

CAUTION: Do NOT remove any non-bar-coded specimens


from the racks until the specimen ID numbers are matched
to the rack number and tube position and entered on the
record.

CAUTION: If a fault occurs which requires or causes the


Sample Loader to be reinitialized, the operator must
remove the specimens that have been processed to avoid
accidentally repeating a specimen. Whenever the Sample
Loader reinitializes, the Tube Rack that was under the
Tower when the Sample Loader stopped moves back to the
starting position. Processing, therefore, starts again with
the tube in position number one of that rack.

The operator must pay careful attention to the rack number and
tube position of each sample being processed, particularly when
not using bar code labels and when using the Work List. For a
complete explanation of the Work List, see Chapter 5: Operating
Instructions.

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Sample Loader
Operating Principles Chapter 12

Function Sequence
The following sequence is a basic description of the events that
occur from the time that the Sample Loader power is turned ON
through the complete processing cycle. During the cycle, the
position of the Tube Racks is monitored by four reflective sensors
in the corners of the Sample Loader tray. Another sensor detects
the non-reflective black mark on the End Rack.
1. Each time the Sample Loader is switched ON, it completes an
Initialization cycle.
2. When the Sample Loader is initialized and ready, the START
key on the Sample Loader Keyboard flashes and the message
AUTO SAMPLER READY appears in the Data Station Bulletin
Line.
3. When the START key is pressed, the Sample Loader begins
moving the right rear rack under the tower. As the rack
advances, the sensor at the Pre-Mixing Station searches for a
tube. When the sensor detects a tube, the rack advances it to
the Mixing Station. The second tube in the rack is positioned
at the Pre-Mixing Station.
4. The Mixing Head moves down until the height sensor senses
the tube at the Mixing Station. Mixing begins at the same
time that the bar code label is read. If no bar code label is
present, the sample is identified by rack number and tube
position or by a Work List entry. (For instructions on using
the Work List, refer to Chapter 5: Operating Instructions.)
5. The first specimen is then mixed by counter-rotation for
approximately 60 seconds. When approximately 30 seconds
have elapsed, the second tube begins mixing. The total
mixing time for each sample is approximately 60 seconds.
NOTE: Tubes must be able to spin freely while in the tube
racks. Tubes with excessive numbers of labels or with label
flaps sticking out will not spin properly and may cause the
Sample Loader to stop. (Refer to Figure 12.3, Tube Labeling
Requirements.) The Bulletin Line will display the
following message: SAMPLING ERROR — INCOMPLETE
ASPIRATION. The RUN screen will display the MIXING
ERROR and SAMPLING ERROR messages.

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Sample Loader
Chapter 12 Operating Principles

The Sample Loader does not attempt to aspirate an


improperly mixed sample. Therefore, the SAMPLING
ERROR — INCOMPLETE ASPIRATION message is
displayed along with the MIXING ERROR message, and
results look like background counts. In addition, results
from tubes that cannot spin properly (and therefore are
not mixed) also look like background results.
If the tube cannot spin, the Sample Loader emits three
beeps, the Mixing Head motor stops (to prevent damage to
the motor), and the sample is not aspirated. The message
MIXING ERROR is displayed and printed to the right of the
MCH result, and the message SAMPLING ERROR is
displayed and printed to the right of the MCHC result. An
“M” appears in the column preceding the date in the Data
Log and the QC Log.
6. Rack movement resumes, and the first tube is moved to the
Vent/Aspiration Station. When the Vent/Aspiration Needle
begins to move down, the Plunger moves forward to position
the tube so the stopper is pierced near the center. The needle
continues to move down and pierces the stopper to vent the
tube. The needle moves down to the bottom of the tube and
the Sample Loader signals the Analyzer to aspirate the sample.
The sample is pulled into the Shear Valve by the Sample
Aspiration Pump. The Analyzer then begins a normal count
cycle.
NOTE: If the Sample Loader detects four consecutive
metering faults or incomplete aspirations, the Sample
Loader stops and the Bulletin Line message alternates
between SAMPLING ERROR — INCOMPLETE
ASPIRATION and AUTO SAMPLER CONSECUTIVE
DATA FAULTS and AUTO SAMPLER BUSY. The message
SAMPLING ERROR is displayed and printed to the right of
the MCHC result. Troubleshoot metering faults
appropriately for clogs and other likely causes.

7. While Tube #1 is being aspirated, the Bar Code Reader


identifies Tube #2, either by reading the bar code label on the
tube or by reading the rack number and tube position. Tube
#2 is then mixed for 30 seconds.

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Sample Loader
Operating Principles Chapter 12

8. Tube #3 is sensed by the tube sensor and pre-mixed for


approximately 30 seconds.
NOTE: Whenever there is an empty space in a rack,
mixing timing returns to that of the first tube in the first
rack. When an empty space is detected, the Sample Loader
automatically advances the next tube directly to the
mixing station and mixes it for approximately 60 seconds.
This has only a minor effect on overall throughput but may
become significant if there are numerous empty spaces.

9. After the sample is aspirated, the Vent/Aspiration Needle is


retracted and washed. The plunger retracts when the needle
has been fully withdrawn from the tube.
10. Steps 4–9 are repeated until all the tubes in the rack have
been processed.
11. When the last tube in the rack is at the Mixing Station, the
rack sensor senses that the rack has moved far enough to the
left side of the Sample Loader Tower. The second rack is
moved into position on the right side of the tower and the
first tube is positioned at the Pre-Mixing Station.
12. These sequences are repeated until the End Rack sensor
detects the End Rack. When all tubes in this rack are
processed, the Sample Loader automatically stops and
audible beeps alert the operator that processing is completed.
The message SAMPLES COMPLETED is displayed in the
Bulletin Line.
NOTE: If no End Rack is used, processing continues until
the Sample Loader is manually stopped by pressing the
PAUSE key, or until a fault occurs.

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Chapter 12 Sample Loader

Routine Operating Procedures

Directions for routine operation with the Sample Loader are given
in Chapter 5: Operating Instructions.

Operating Tips

1. All samples which have been sitting for an extended period of


time must be properly mixed before they are placed in the
Sample Loader racks.
2. Spaces must be left between tubes with rubber stoppers
when they are placed in the Sample Loader rack. If the tubes
are placed side by side, mixing errors will occur because the
rubber stoppers will touch each other when the tubes spin.
3. If a tube has multiple labels on it, spin the tube by hand
after it is put in a rack to be sure it will spin freely and mix
properly.

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Routine Operating Procedures Chapter 12

NOTES

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Chapter 12 Sample Loader

Other Chapters to Reference

Maintenance
Maintenance procedures for the Sample Loader should be
performed as directed in Chapter 9: Maintenance. These
procedures consist of cleaning the Safety Cover, the Vent/
Aspiration Needle, the Tray, and the Tube Racks. If the Vent/
Aspiration Needle requires replacement, refer to Chapter 10:
Troubleshooting, Subsection: Troubleshooting Guide.

Set Up
For detailed instructions on how to set up the Sample Loader, refer
to Chapter 2: Installation.

Troubleshooting
If a Sample Loader fault, error, or other problem is detected, an
alert message is displayed on the Bulletin Line of the screen. For a
list of messages, descriptions of possible problems, and
recommended actions, refer to Chapter 10: Troubleshooting.

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Sample Loader
Other Chapters to Reference Chapter 12

NOTES

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Chapter 13 Veterinary Package
Veterinary Package

Introduction

The Veterinary Package software enables the CELL-DYN® 3700


System to analyze animal samples. When the Vet Package is
selected, the instrument can be configured to process veterinary
samples. The software stores instrument settings for up to 60
different types of animals in a configuration file unique to each
animal type. A database in the Vet Package, called the Animal
Catalog, contains manufacturer-developed settings for common
species. Additional species may be added at the discretion of the user.
By pressing the appropriate soft keys, the operator can switch
between species or return to the original instrument (human)
settings.
In this chapter you will find the information needed to configure
the system to run animal samples.
• Access the Vet Package from the Set Up Menu
• Add a new animal specie and enter normal ranges for that
animal
• Run the animal samples and make changes to the gain
settings for appropriate CBC and differential results
• Calculate and calibrate the MCV for each new animal
• Adjust the Baso Box
The following information regarding the use of the Veterinary
Package is included in this chapter:

Principles of Operation
Performance Characteristics
Operating Instructions (including a description of the
soft keys)
Calibration
Quality Control
Adding New Animal Types (including instructions for
configuring additional species)
Turning the Vet Package OFF

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Introduction Chapter 13

NOTES

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Chapter 13 Veterinary Package

Principles of Operation

The Vet Package is designed to configure the instrument to


process up to 60 different animal types. The configuration file for
each animal type can be customized for the following:
Electronic set-points
Calibration factors (MCV and MPV)
Limits Sets
When a particular species is selected, the instrument will
automatically choose the appropriate configuration file and adjust
the instrument settings to the values contained in the file. This
configuration is retained until another species is selected or the
Vet Package is turned OFF. When the Vet Package is turned OFF,
the instrument automatically returns to the original settings for
human samples.
Adjustments to the instrument settings (for calibration or
alignment) are always made in the human mode. Therefore, a
special animal type called “Default” is maintained in the Animal
Catalog (described in the next section) and in the Animal Type
Set Up Table. The settings for the default animal are identical to
the settings for humans and all animal settings are maintained
relative to these settings. When the instrument is calibrated or
any procedures are performed which alter the default animal
(human) settings, the settings contained in all of the animal type
files are automatically adjusted according to the altered default
settings. Consequently, the animal configurations are always
current and no adjustments are required.

The Animal Catalog


The Animal Catalog contains the pre-programmed configuration
files for common species.
NOTE: All claims and specifications in this chapter are
based on these pre-programmed animal types. No
instrument performance claims can be provided for
species configured by the user.

Files stored in the catalog, including the “Default” animal type,


cannot be modified within or deleted from the catalog. However,
these files can be reviewed or added to the Animal Type Set Up
Table at any time, where they then can be edited.

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Veterinary Package
Principles of Operation Chapter 13

The “Default” animal type stored in the catalog cannot be


modified or deleted. It is a duplication of the original human
settings, with their calibration and dilution factors, that were
established for the Analyzer.
To run samples for the first time, a configuration file must be
copied from the catalog to the Animal Type Set Up Table. This
table is displayed on the ANIMAL TYPE SET UP screen. Once the file
is stored in this table, it can be reviewed, modified, or deleted.
Modifications to the file are stored in the Animal Type Set Up
Table and do not alter the settings stored in the catalog.
Consequently, a “Master File” is always maintained in the catalog
for each species.
CAUTION: Do not modify the alignment and calibration
factors for the default animal on the DIAGNOSTICS SET
POINT ENTRY screen. Any changes to these settings would
also modify the settings used for human sample testing
and the Bulletin Line would display the following
message to alert the operator: WARNING: Any change
to the DEFAULT settings also affects the
HUMAN settings. After the Vet Package is exited, the
human settings would then reflect these modifications
made while in the Vet Package.

Once the file is copied to the Animal Type Set Up Table, it may be
accessed by pressing the [ANIMAL TYPE] key displayed on the RUN
screen. When the key is pressed, the settings for that species are
transferred to the Analyzer. (It takes approximately 10 seconds
for the transfer to occur.) When the Status Box displays the
READY message, samples may be processed. Samples from other
species may be processed by again pressing the [ANIMAL TYPE] key
and selecting the desired animal.

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Chapter 13 Veterinary Package

Performance Characteristics

Introduction
Instrument performance specifications are included in Chapter 4:
System Specifications. The Performance Characteristics included
in this section illustrate instrument performance for the species
indicated.

Precision
Precision results are derived from paired difference analysis of a
minimum of 100 data pairs from normal animal samples. The
results are stated as a coefficient of variation (CV).

Table 13.1: Precision

Parameter Result (CV)


Dog Cat Rat ** Mouse1
WBC 3.8% 3.8% 2.4% 3.8%
RBC 2.3% 2.3% 2.0% 2.5%
HGB 1.5% 1.5% 1.5% 1.5%
MCV 3.5% 3.0% 2.2% 2.8%
PLT 8.5%* 11.3%* 4.2% 6.0%*
* The PLT result was derived from a data set which includes
samples exhibiting overlap between the RBC and PLT popula-
tions. Platelet precision is improved if these samples are elimi-
nated from precision determinations.
**Rat precision was calculated with n=31; pooled blood of four
healthy rats.

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Veterinary Package
Performance Characteristics Chapter 13

Accuracy
Accuracy is expressed as a correlation coefficient based on a
minimum of 50 pairs of samples. The data are correlated to a
reference methodology. Dog and cat hemogram parameters are
compared to a Coulter® S+IV and differential parameters are
compared to a manual 100-cell differential. Rat and mouse
hemogram parameters are compared to Contraves AL820® and
differential parameters are compared to a manual 100-cell
differential.

Table 13.2: Accuracy

Parameter Correlation Coefficient


Dog Cat Rat1 Mouse1
WBC > 0.96 > 0.92 > 0.99 > 0.99
RBC > 0.98 > 0.98 > 0.99 > 0.92
HGB > 0.95 > 0.96 > 0.99 > 0.98
MCV > 0.75 > 0.75 > 0.85 > 0.86
PLT > 0.91 > 0.77 > 0.94 > 0.97
% Neutrophils > 0.76 > 0.77 > 0.89 > 0.96
% Lymphocytes > 0.70 > 0.70 > 0.77 > 0.93
% Monocytes NA NA NA NA
% Eosinophils > 0.70 > 0.70 NA NA
% Basophils NA NA NA NA

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Veterinary Package
Chapter 13 Performance Characteristics

Linearity
Linearity was evaluated by testing specimens with high values for
the parameters indicated in the table. The highest values tested
and correlated to a Coulter® S+IV or Contraves AL820® are listed
in the following table.
Table 13.3: Linearity

Parameter Highest Value Tested


Dog Cat Rat1 Mouse1
WBC 70.0 K/µL 43.0 K/µL 20.2 K/µL 19.4 K/µL
RBC 9.56 M/µL 9.98 M/µL 14.3 M/µL 11.1 M/µL
HGB 21.5 g/dL 16.0 g/dL 26.8 g/dL 20.9 K/µL
MCV 150 fL 150 fL NA NA
PLT 950.0 K/µL 800 K/µL 1670 K/µL 1690 K/µL
NOTE: There are no preset limits for parameters that
would generate out-of-range flags like those generated
with the human settings. The maximum values that can
be displayed for the hemogram parameters are:
WBC – 9999 K/µL
RBC – 9999 M/µL
HGB – 9999 g/dL
MCV – 9999 fL
PLT – 9999 K/µL

Carryover
Carryover is determined by running samples with high
concentrations of WBCs, RBCs, HGB, and PLTs. Each sample is
run in triplicate followed by three background cycles. The
percent carryover is calculated using the following formula:
Background1 – Background3
% Carryover = x 100
Sample3 – Background3
Table 13.4: Carryover

Parameter Carryover
Dog Cat Rat1 Mouse1
WBC < 1% < 1% < 1% < 1%
RBC < 1% < 1% < 1% < 1%
HGB < 1% < 1% < 1% < 1%
PLT < 3.5% < 3.5% < 3.5% < 3.5%

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Veterinary Package
Performance Characteristics Chapter 13

Flagging
The following Suspect Population Flags, and Suspect Parameter
Flags are active in the Vet Package software:
WBC
DFLT (NLMEB)
NWBC
FWBC
NRBC
RRBC
PLTR
Descriptors:
WIC
WOC
The interpretive messages described in Chapter 3: Principles of
Operation, Subsection: Operational Messages and Data Flagging are
also active in the Vet Package.
Samples may be flagged by entering up to four sets of limits for
each animal type. Limits may be normal range, panic values, etc.
Values that fall outside these limits are displayed and printed as
they are for human samples. When a result exceeds the
maximum value that the system can display, >>>> (over-range)
are displayed and printed in place of the result.

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Chapter 13 Veterinary Package

Operating Instructions

The operation of the Vet Package is discussed in the remaining


sections of this chapter. There are four main sections:
Vet Package Keys
Routine Operation
Calibration
Adding New Animal Types

A description of the Vet Package set up procedures and how to


access the various Vet Package functions is given in the first
section. The Routine Operation section includes instructions for
Sample Analysis and brief descriptions of the Work List and the
Data Log. Calibration procedures are discussed in the Calibration
section, and the steps required to add new species are described
in the Adding New Animal Types section.

OPERATION SET UP MENU Dec 01 1998 14:32


Ready Operator ID 757
Sequence # 3404

TURN ON TURN ON BAR CODE COMPUTER RETURN


VET PKG RETIC PKG SET UP SET UP

Figure 13.1: Operation Set Up Menu Screen

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Vet Package Keys


TURN ON The [TURN ON VET PKG] key is located on the OPERATION SET UP
VET PKG MENU screen (see the preceding figure), which is accessed from
TURN VET
PKG OFF
the SET UP MENU screen. When the [TURN ON VET PKG] key is
pressed, the key label will change to [TURN VET PKG OFF] and the
Vet Package software will be enabled. This key is used to enable
or disable the Vet Package. When the Vet Package is ON, the Vet
Package keys described on the following pages are accessible.

Procedure:
Turn Vet Package ON
1. From the MAIN MENU screen, press the [SET UP] key followed
by the [OPERATION SET UP MENU] key to display the
OPERATION SET UP MENU screen.
2. From the OPERATION SET UP MENU screen, press the [TURN ON
VET PKG] key to enable the Vet Package software.
NOTE: The key label changes to [TURN VET PKG OFF] when
the Vet Package is selected.

3. Press the [RETURN] key followed by the [SET UP] key to return
to the SET UP MENU screen.
The [ANIMAL SET UP] key is now displayed.

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SET UP MENU Dec 01 1998 14:33


Ready Operator ID 757
Sequence # 3404

DATE/ ANIMAL REAGENT QC SET UP OPERATION UNITS CUSTOMIZE MAIN


TIME SET UP LOG MENU SET UP SELECTION REPORT

Figure 13.2: Set Up Menu Screen

ANIMAL The [ANIMAL SET UP] key is displayed on the SET UP MENU screen
SET UP (see the preceding figure) when the Vet Package is ON. When the
[ANIMAL SET UP] key is pressed, the ANIMAL TYPE SET UP screen (see
the following figure) and the following soft key labels are
displayed:
ADD NEW ANIMAL
DELETE ANIMAL
VIEW ANIMAL
ANIMAL LIMITS
BROWSE CATALOG
RETURN

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ANIMAL TYPE SET UP Dec 01 1998 14:33


Ready Operator ID 757
Sequence # 3404

CAT
DEFAULT
DOG
MOUSE
RAT

ADD NEW DELETE VIEW ANIMAL BROWSE RETURN


ANIMAL ANIMAL ANIMAL LIMITS CATALOG

Figure 13.3: Animal Type Set Up Screen

ADD NEW The [ADD NEW ANIMAL] key is used to add a new animal type to the
ANIMAL Animal Type Set Up Table. This key is discussed and directions for
adding new animals are given in the Adding New Animal Types
section of this chapter.
DELETE The [DELETE ANIMAL] key is used to delete the file indicated by the
ANIMAL cursor position from the Animal Type Set Up Table. The
following soft key labels are displayed when the [DELETE ANIMAL]
key is pressed:
CONFIRM DELETION
CANCEL DELETION
These keys are used to confirm or cancel the Delete Animal
command.

Procedure: Delete Animal


1. From the SET UP MENU screen, press the [ANIMAL SET UP] key
to display the ANIMAL TYPE SET UP screen.
2. Use the arrow keys on the keyboard to move the cursor to
the animal that is to be deleted.

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3. Press the [DELETE ANIMAL] key followed by the [CONFIRM


DELETION] key. Verify that the selected animal is deleted
from the list.
NOTE: The animal type to be deleted must not be the
current animal type selected in the RUN screen. The
default animal type cannot be deleted.

VIEW ANIMAL TYPE SET UP Dec 01 1998 14:37


Ready Operator ID 757
Sequence # 3404

DEFAULT SET UP
Gains: WBC 0D 1408
WBC 10D 1267
WBC 90D 1401
WBC 90DEP 1465 Current HGB 1680
RBC 1817 RBC 2930
PLT 2147 WIC 3000
WIC 3307

THRESH: WBC 360 Calibration Factors


RBC 240
PLT lo 230 MCV 0.903
PLT hi 4095 MPV 1.107
WIC lo 640
WIC hi 3000

PRINT RETURN

Figure 13.4: View Animal Type Set Up Screen

VIEW The [VIEW ANIMAL] key displays the configuration file for the
ANIMAL animal type indicated by the cursor position on the ANIMAL TYPE
SET UP screen. The VIEW ANIMAL TYPE SET UP screen is shown in
the preceding figure.

Procedure: View Animal


1. From the SET UP MENU screen, press the [ANIMAL SET UP] key
to display the ANIMAL TYPE SET UP screen.
2. Use the arrow keys on the keyboard to move the cursor to
the animal that is to be viewed.
3. Press the [VIEW ANIMAL] key to display the VIEW ANIMAL TYPE
SET UP screen for the selected animal.

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LIMIT SET 1 Dec 01 1998 15:01


Animal: DOG
Ready Operator ID 757
Sequence # 3404

Lower Limits Upper Limits


WBC 6.7 K/uL 18.3 K/uL
NEU 3.6 K/uL 60.0 %N 12.5 K/uL 75.0 %N
LYM 0.7 K/uL 12.0 %L 6.0 K/uL 30.0 %L
MONO 0.1 K/uL 3.0 %M 1.7 K/uL 9.0 %M
EOS 0.1 K/uL 2.0 %E 1.8 K/uL 10.0 %E
BASO 0.0 K/uL 0.0 %B 0.1 K/uL 1.0 %B
RBC 5.50 M/uL 8.20 M/uL
HGB 12.6 g/dL 19.4 g/dL
HCT 36.9 % 55.0 %
MCV 62.0 fL 70.0 fL
MCH 22.0 pg 25.0 pg
MCHC 33.0 g/dL 36.0 g/dL
RDW 11.6 % 14.8 %
PLT 80. K/uL 560. K/uL
MPV 0.0 fL 99.9 fL
PCT 0.00 % 9.99 %
PDW 0.0 10(GSD) 99.9 10(GSD)

LIMIT LIMIT LIMIT PRINT RETURN


SET 2 SET 3 SET 4

Figure 13.5: Animal Limit Set 1

ANIMAL The [ANIMAL LIMITS] key is used to enter upper and lower flagging
LIMITS limits for each animal in the Animal Type Set Up Table. Four
different sets of limits may be entered for each animal type. The
animal type is displayed on the upper left corner of each Limit
Set. The following soft key labels are displayed (see the preceding
figure) when the [ANIMAL LIMITS] key is pressed:
LIMIT SET 1*
LIMIT SET 2
LIMIT SET 3
LIMIT SET 4
PRINT
RETURN
*The key label for the Limit Set displayed on the screen is not shown.

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Whenever a parameter result exceeds an entered limit, the result


is displayed in color on the screen to alert the operator. Results
displayed in yellow are below the limit and results displayed in
purple are above the limit. The flagged result is underlined on the
graphics report and the blank ticket report. The flagged result is
marked with an asterisk (*) on the pre-printed ticket report.
NOTE: To avoid data entry errors, limits can only be
entered for the animal type that is currently displayed on
the RUN screen.

Procedure: Animal Limits


1. From the MAIN MENU screen, press the [RUN] key followed by
the [ANIMAL TYPE] key.
2. Use the arrow keys on the keyboard to move the cursor to
the desired animal in the list displayed on the screen.
3. Press the [SELECT ANIMAL] key to set the instrument for the
selected animal. The Status Box briefly displays the message
Setting gains followed by the Ready message.
4. When the Ready message is displayed, press the [RETURN]
key to return to the RUN screen.
5. Press the [MAIN] key followed by the [SET UP] key to return to
the SET UP MENU screen.
6. From the SET UP MENU screen, press the [ANIMAL SET UP] key
to display the ANIMAL TYPE SET UP screen.
7. Press the [ANIMAL LIMITS] key to display the ANIMAL LIMITS
screen. A Limit Set is displayed on the screen. The set
number (Limit Set 1, Limit Set 2, etc.) is displayed in the
Status Box, and the animal type is displayed in the upper left
corner of the screen. The other Limit Sets may be selected by
pressing the appropriate soft key.
8. Use the arrow keys on the keyboard to move the cursor to
the desired limit entry field and type the number.
9. Press the Enter key on the keyboard to save the entry and
advance the cursor to the next entry position.
10. Repeat steps 8 and 9 until all desired entries have been made.
11. If desired, press the [PRINT] key to obtain a printout of the
Limit Set.
NOTE: Retaining a hard copy of each Limit Set is
recommended, as the screens do not display categories for
the Limit Sets.

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Operating Instructions Chapter 13

12. Press the appropriate soft key to select another Limit Set and
repeat steps 8–11 to enter the desired limits.
13. Press the [RETURN] key to return to the ANIMAL TYPE SET UP
screen.
14. Repeat this procedure to enter limits for a different species.

ANIMAL TYPE CATALOG Dec 01 1998 14:39


Ready Operator ID 757
Sequence # 3404

CAT
DEFAULT
DOG
MOUSE
RAT

VIEW EXPECTED ADD TO RETURN


SET UP RANGES SET UP

Figure 13.6: Animal Type Catalog Screen

BROWSE The [BROWSE CATALOG] key is used to view the Animal Catalog.
CATALOG The Animal Catalog stores the files for up to 60 different animal
types. Information for the animal types currently supported by
existing data is stored in the catalog. To run samples from a
specific animal, the file must be moved from the catalog to the
Animal Type Set Up Table. When the [BROWSE CATALOG] key is
pressed, the ANIMAL TYPE CATALOG screen and the following soft
key labels are displayed (see the preceding figure):
VIEW SET UP
EXPECTED RANGES
ADD TO SET UP
RETURN

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CATALOG CONTENTS
Ready Dec 01 1998 14:39
ANIMAL TYPE SET UP Operator ID 757
Sequence # 3404

CAT SET UP
Gains: WBC 0D 1948
WBC 10D 1397
WBC 90D 2866
WBC 90DEP 2998 Current HGB 1680
RBC 3388 RBC 2930
PLT 2258 WIC 3000
WIC 3307

THRESH: WBC 400 Calibration Factors


RBC 240
PLT lo 257 MCV 0.519
PLT hi 4095 MPV 1.127
WIC lo 520
WIC hi 3000

PRINT RETURN

Figure 13.7: Catalog Contents, Animal Type Set Up Screen

VIEW When the [VIEW SET UP] key is pressed, the CATALOG CONTENTS,
SET UP ANIMAL TYPE SET UP screen (see the preceding figure) for the
animal type indicated by the cursor position and the following
soft key labels are displayed:
PRINT
RETURN
NOTE: The file cannot be modified from this screen, only
displayed and printed.

PRINT The [PRINT] key is used to print a copy of the displayed settings.

RETURN The [RETURN] key is used to return to the ANIMAL TYPE CATALOG
screen.

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EXPECTED RANGES Dec 01 1998 14:41


Animal: DEFAULT
Ready Operator ID 757
Sequence # 3404

Lower Limits Upper Limits


WBC 4.60 K/uL 10.2 K/uL
NEU 2.00 K/uL 37.0 %N 6.90 K/uL 80.0 %N
LYM .600 K/uL 10.0 %L 3.40 K/uL 50.0 %L
MONO 0.00 K/uL 0.00 %M .900 K/uL 12.0 %M
EOS 0.00 K/uL 0.00 %E .700 K/uL 7.00 %E
BASO 0.00 K/uL 0.00 %B .200 K/uL 2.50 %B
RBC 4.04 M/uL 6.13 M/uL
HGB 12.2 g/dL 18.1 g/dL
HCT 37.7 % 53.7 %
MCV 80.0 fL 97.0 fL
MCH 27.0 pg 31.2 pg
MCHC 31.8 g/dL 35.4 g/dL
RDW 11.6 % 14.8 %
PLT 142. K/uL 424. K/uL
MPV 0.00 fL 100. fL
PCT 0.00 % 9.99 %
PDW 0.00 10(GSD) 100. 10(GSD)

PRINT RETURN

Figure 13.8: Expected Ranges

EXPECTED The [EXPECTED RANGES] key is used to display the pre-


RANGES programmed ranges for the animal type indicated by the cursor
position. (See the preceding figure.)
NOTE: When a file is transferred from the Animal
Catalog to the Animal Type Set Up Table, the expected
ranges stored in the catalog become Limit Set 1.

ADD TO The [ADD TO SET UP] key is used to move the configuration file
SET UP indicated by the cursor position from the Animal Catalog to the
Animal Type Set Up Table.

Procedure: Add to Set Up


1. From the ANIMAL TYPE SET UP screen, press the [BROWSE
CATALOG] key to display the ANIMAL TYPE CATALOG screen.
2. Use the arrow keys on the keyboard to move the cursor to
the desired animal type.

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3. Press the [ADD TO SET UP] key to move the file to the Animal
Type Set Up Table.
NOTE: If the selected file has already been moved to the
Animal Type Set Up Table, the Bulletin Line will display
the message: Animal type was added to set up
already. The file with the same name must be deleted
from the Animal Type Set Up Table before the selected file
can be added.

4. Press the [RETURN] key to return to the ANIMAL TYPE SET UP


screen. The added file is entered in the list and displayed in
alphabetical order.
PRINT The [PRINT] key is used to print a list of the files contained in the
Animal Catalog.

RETURN The [RETURN] key is used to return to the ANIMAL TYPE SET UP
screen. The [RETURN] key on the ANIMAL TYPE SET UP screen is
used to return to the SET UP MENU screen.

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NOTES

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Chapter 13 Veterinary Package

Routine Operation

This section gives instructions for running veterinary samples. A


brief discussion of the Data Station RUN screen is included to
explain the different keys displayed when the Vet Package is ON.

RUN
Next ID CAT/10533/03 Auto Dec 01 1998 09:44
Ready
Animal: CAT Operator ID 732
Sex(M/F):M DOB:01/09/92 Report for CAT/10552/02 Sequence # 1702
Dr FELINE, DVM XB RBC:1/OUT2 XB WBC WL:OFF Open Sampler
Param: 1 Limits: 1
9
WBC 7.24 K/uL 0
NEU 4.75 65.6 %N S
LYM 1.63 22.5 %L I d
Z e
MONO .566 7.82 %M
E g
EOS .168 2.33 %E
BASO .129 1.79 %B
WCT:4.33
RBC 4.18 M/uL COMPLEXITY 10 deg
HGB 13.1 g/dL
HCT 37.4 %
MCV 89.5 fL
MCH 31.4 pg
MCHC 35.1 g/dL
RDW 14.9 %

PLT 219. K/uL


MPV 7.54 fL RCT:6.26 RBC PLT

CLEAR WORK ANIMAL CUSTOMIZE CHANGE PRINT PRINT MAIN


APERTURES LIST TYPE REPORT SAMPLER TICKET REPORT

Figure 13.9: Run Screen for Animals

Run Screen
The RUN screen for animals differs slightly from the RUN screen
for humans. The preceding figure shows the RUN screen for
animals. On this screen, the <PATIENT> field is replaced by the
<ANIMAL> field. The selected animal type is automatically
displayed in this field.
The [SPECIMEN TYPE] key is replaced by the [ANIMAL TYPE] key.
However, the [SPECIMEN TYPE] key is available from the ANIMAL
TYPE SELECTION screen.
NOTE: Animal type and specimen type are two
independent characteristics of the sample. For example,
Dog QC, Cat Background, etc.

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Selecting the Animal

ANIMAL TYPE SELECTION Dec 01 1998 14:43


Ready Operator ID 757
Sequence # 3404

CAT
DEFAULT
DOG
MOUSE
RAT

SELECT SPECIMEN RETURN


ANIMAL TYPE

Figure 13.10: Animal Type Selection Screen

ANIMAL When the [ANIMAL TYPE] key on the RUN screen is pressed, the
TYPE ANIMAL TYPE SELECTION screen (see the preceding figure) and the
following soft key labels are displayed:
SELECT ANIMAL
SPECIMEN TYPE
RETURN

Adjusting the Settings


SELECT The [SELECT ANIMAL] key is used to adjust the instrument to the
ANIMAL animal settings determined by the cursor position. When the key
is pressed, the Status Box briefly displays the message Setting
gains to indicate that the adjustments are in process. This
message is immediately followed by the Ready message
indicating the adjustments are complete.

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SPECIMEN TYPE Dec 01 1998 14:45


Ready Operator ID 757
Sequence # 3404

File Name # Specimens File Name # Specimens

1. LOW 44 SL 3 11. PRECOP02/01 31


2. NORM 44 SL 3 12. PRECSL02/01 31
3. HIGH 44 SL 3 13. PRECSL01/29 31
4. LOW 45 OPEN 3 14. LOW RD 13 OP 71
5. NORM 45 OPEN 3 15. NOR RD 13 OP 71
6. HIGH 45 OPEN 3 16. HI RD 13 OP 69
7. LOW 44 HSL 0 17. PRECOP01/27 31
8. NORM 44 HSL 0 18. PRECSL01/27 31
9. HIGH 44 HSL 0 19. PRECOP01/29 34
10. PRECSL01/28 31 20. PRECOP01/28 31

Press QC SPECIMEN key to select QC FILE at cursor position.

PATIENT QC BACK- ELECTRICL LATEX RESISTANT RETURN


SPECIMEN GROUND BACKGRND RBC

Figure 13.11: Specimen Type Screen

Choosing the Specimen Type


SPECIMEN When the [SPECIMEN TYPE] key is pressed, the SPECIMEN TYPE
TYPE screen (see the preceding figure) and the following soft key labels
are displayed:
PATIENT
QC SPECIMEN
BACKGROUND
ELECTRICL BACKGRND
LATEX
RESISTANT RBC
RETURN
The functions of these keys are discussed in Chapter 5: Operating
Instructions.

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RUN
Animal: DOG Ready Dec 01 1998 10:20
Type BACKGROUND Report for BACKGROUND Operator ID 757
Param Set: 1 Sequence # 4166
WL:OFF Open Sampler
WBC 0.12 K/uL
G
NEU %N R
LYM %L S A
MONO %M I N
Z L
EOS %E E R
BASO %B T
Y
WCT:4.57
RBC .001 M/uL
HGB 009 g/dL COMPLEXITY LOBULARITY
HCT %
MCV fL
MCH pg
MCHC g/dL
RDW %

PLT 0.00 K/uL


MPV fL
RCT:6.23 RBC PLT

CLEAR WORK ANIMAL CUSTOMIZE CHANGE PRINT COLOR MAIN


APERTURES LIST TYPE REPORT SAMPLER TICKET PRINT

Figure 13.12: Dog Background Count

When the Vet Package is ON, the screens differ in that the
selected animal type is always displayed in the upper left corner
of each of the specimen type RUN screens. See the preceding
figure for an example of a BACKGROUND screen for a dog.

Sample Analysis
Veterinary samples may be run in the Open Mode or the Closed
Mode (SL or CS) on the CELL-DYN 3700 System. Once the animal
type is selected, these samples are processed in the same manner
as human samples. Daily Start Up Procedures and Quality
Control checks should be performed before processing samples.
For instructions for these procedures, refer to Chapter 5:
Operating Instructions, Subsections: Daily Start Up Procedure, Daily
Quality Control Procedures, and Sample Analysis.

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Procedure: Selecting Animal Type/Specimen Type


NOTE: In the following procedure, [ANIMAL TYPE] refers
to the species being sampled. [SPECIMEN TYPE] refers to the
following selections available on the RUN screen:

Patient
QC Specimen
Background
Electrical Background
Latex
Resistant RBC (in the Open Mode only)
1. From the MAIN MENU screen, press the [RUN] key followed by
the [ANIMAL TYPE] key.
2. Use the arrow keys on the keyboard to move the cursor to
the desired animal and press the [SELECT ANIMAL] key.
The Status Box briefly displays the message Setting
gains and returns to the Ready message.
3. When the Ready message is displayed, press the [SPECIMEN
TYPE] key.
4. Press the soft key for the desired specimen type and then
press the [RETURN] to display the RUN screen for the selected
specimen type.
5. Run the sample in the selected mode of operation.
6. To run a different species, press the [ANIMAL TYPE] key.
7. Move the cursor to the desired animal and press the [SELECT
ANIMAL] key.
8. Press the [RETURN] key to display the RUN screen for the
selected animal type.
9. Run the sample in the selected mode of operation (Open or
Closed).
10. Repeat this procedure to run samples from a different
species.

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Sample Analysis with the Work List


A Work List can be created for only one species at a time.
Therefore, animal samples must be batched to use this feature
(for example, all dog samples must be run together, all cat
samples must be run together, etc.). Sample analysis with the
Work List is identical to that described in Chapter 5: Operating
Instructions.

Data Log
All veterinary samples are entered in the Data Log in the order in
which they are processed. All samples run with the Vet Package
ON are stored with the Data Log code V to indicate veterinary
samples.

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Chapter 13 Veterinary Package

Calibration

With the Vet Package ON, calibration of the directly measured


parameters is linked to the calibration factors set for human
(“Default” animal type) samples. When the calibration factors for
human (“Default” animal type) samples are changed, the
calibration factors contained in the configuration files stored in
the Animal Type Set Up Table are automatically updated.
Calibration factors for WBC, RBC, HGB, and PLT always remain
identical to the factors for the default animal type. This is true for
all species listed in the Animal Type Set Up Table.
CAUTION: The calibration factors for these parameters
are always identical to those for human samples. Don’t
modify the alignment and calibration factor settings for
the default animal on the Animal Type Set Up Table. Any
changes to these settings would also modify the settings
used for human sample testing and the Bulletin Line
would display the following message to alert the operator:
WARNING: Any change to the DEFAULT settings
also affects the HUMAN settings. After the Vet
Package is exited, the human settings would then reflect
these modifications made while in the Vet Package.

Calibration factors for MCV and MPV may differ from those for
the default animal type. These calibration factors may also differ
among the species. If a calibration factor is not entered in the
configuration file for these parameters, the factors for the default
animal type will be used. If calibration factors are entered for
these parameters, they will be linked to the factors for the default
animal type. Whenever the default factors are changed, these
factors will be automatically updated.
When the calibration factors for MCV and MPV have been
computed, they are entered manually from the ENTER
CALIBRATION FACTOR screen (see the following figure) in the
Calibration menu as directed on the following pages.

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Calibration Chapter 13

Procedure: MCV or MPV Calibration


Once the animal type is selected, directions for MCV or MPV
calibration are identical to those given in Chapter 6: Calibration.
For Open Mode calibration, use the Manual Calibration procedure
for the Open Mode. For the Closed Mode (SL or CS), use the
Manual Mode to Mode Calibration procedure.

ENTER CALIBRATION FACTOR Dec 01 1998 09:32


Animal: CAT Ready Operator ID 732
Sequence # 1700
Open Sampler

Parameter Factor

MCV 0.486

MPV 0.974

RESTORE RETURN
FACTORS

Figure 13.13: Enter Calibration Factor Screen

Pre-Calibration Procedures
Be certain to complete the procedures outlined in the
Pre-Calibration Procedures section of Chapter 6 before beginning
the calibration procedure. Human blood should be used to verify
specifications.

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Chapter 13 Calibration

Determining the Calibration Factors for MCV and MPV


1. From the MAIN MENU screen, press the [RUN] key followed by
the [ANIMAL TYPE] key.
2. Use the arrow keys on the keyboard to move the cursor to
the desired animal and press the [SELECT ANIMAL] key.
The Status Box briefly displays the message Setting
gains and returns to the Ready message.
3. When the Ready message is displayed, press the [SPECIMEN
TYPE] key.
4. Use the arrow keys on the keyboard to move the cursor to
an empty QC file. Name the file as directed in the
appropriate manual calibration procedure and press the [QC
SPECIMEN] key.
5. Press [RETURN] key to display the RUN screen for the selected
QC file.
6. Run the samples as directed in the appropriate manual
calibration procedure.
7. Compute the MCV and/or MPV calibration factors as
follows:
If the RBC gains or set point entry was changed, a new MCV
Calibration Factor must be calculated as follows:
Default RBC Gains New MCV
x Current Default MCV Cal Factor =
Animal RBC Gains Factor

If platelet gains or set point entry was changed, an new MPV


Calibration Factor must be calculated as follows:
Default PLT Gains New MPV
x Current Default MPV Cal Factor =
Animal PLT Gains Factor

Entering the Calibration Factor


1. From the MAIN MENU screen, press the [CALIBRATION] key.
The MCV and MPV calibration factors for the selected
species and sampler mode are displayed on the screen.
2. If necessary, press the [OPEN SAMPLER] key or the [CLOSED
SAMPLER] key to display the calibration factors for the other
mode.
3. Press the [ENTER FACTOR] key to display the ENTER
CALIBRATION FACTOR screen for the selected mode.

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Calibration Chapter 13

4. Use the arrow keys on the keyboard to move the cursor to


the appropriate factor and type in the new factor. Press the
Enter key on the keyboard to save the entry and advance the
cursor.
5. When the new factor(s) have been entered, press the
[RETURN] key to display the CALIBRATION LOG screen.
6. Document the calibration as directed in the calibration
procedure.
NOTE: It is important to include the name of the species
in the Calibration Log, as it includes records for all
calibrations.

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Chapter 13 Veterinary Package

Quality Control

Quality Control procedures are identical to those described in


Chapters 5: Operating Instructions and Chapter 7: Quality
Control.

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Quality Control Chapter 13

NOTES

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Chapter 13 Adding New Animal Types

Adding New Animal Types

NOTE: The Animal Catalog contains pre-programmed


configuration files for common species. All performance
characteristics given in this chapter are based on these
animal types. Additional species may be configured by the
user, but no instrument performance claims can be
provided.

Adding new species to the Animal Type Set Up Table is a


multistep process, as follows:
• The first step is to create a new configuration file for the
new species.
• The appropriate instrument settings are then computed for
the file by running normal samples from the new species on
the instrument. The position of each scattergram and
histogram is compared to the scattergrams and histograms
for normal human samples. (A diagram is included at the
end of this section for use in comparing the population
locations.) Adjustment factors are computed from these data
for six electronic gain settings.
• The factors are then entered into the configuration file,
which adjusts the Analyzer to the new settings.
• Samples are repeated to verify that the new settings are
correct and the MCV and MPV are recalibrated if necessary.
• Finally, Baso Box adjustments are made if necessary and
samples are repeated to verify changes.

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Adding New Animal Types Chapter 13

Adding a New Configuration File


NOTE: Be sure the Vet Package is ON before creating a
new configuration file.

ADD NEW ANIMAL TYPE Dec 01 1998 09:41


Ready Operator ID 732
Sequence # 1702

New Animal name: NEW ANIMAL NAME

Do you wish to copy this animal from an existing animal?

RETURN

Figure 13.14: Add New Animal Type Screen

NOTE: The name of the new species must be different


from other animal names that are already in the Animal
Type Set Up Table.

1. From the MAIN MENU screen, press [SET UP] key followed by
the [ANIMAL SETUP] key.
2. Press the [ADD NEW ANIMAL] key to display the ADD NEW
ANIMAL TYPE screen shown in the preceding figure.
3. Type in the name of the new species to be added.
The screen displays the following message:
Do you wish to copy this animal from an
existing animal?
If you do not wish to copy this animal from an existing
animal, type N and press the Enter key on the keyboard to
save the entry and advance the cursor. The default settings
will be used to create the new configuration file.

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Chapter 13 Adding New Animal Types

If you do wish to copy this animal from an existing animal,


it must be a species that has similar cellular properties. Type
Y and press the Enter key on the keyboard to save the entry
and advance the cursor.
The screen displays the message:
Animal name to copy from:
Type the exact name of the animal whose configuration file
you wish to copy. Press the Enter key on the keyboard to save
the entry.
4. Run the specimens from the new species.

Setting Up the File


1. From the MAIN MENU screen, press [RUN] key followed by the
[ANIMAL TYPE] key.
2. Use the arrow keys on the keyboard to move the cursor to
the desired animal and press the [SELECT ANIMAL] key.
The Status Box briefly displays the message Setting
gains and returns to the Ready message.
3. When the Ready message is displayed, press the [SPECIMEN
TYPE] key.
4. Press the [PATIENT] key followed by the [RETURN] key to
display the RUN screen for the selected specimen type.

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Adding New Animal Types Chapter 13

RUN
Next ID ----------- Auto Ready Dec 01 1998 10:20
Animal: HORSE Report for BACKGROUND Operator ID 757
Sex(M/F):-M DOB:--/--/-- Sequence # 4166
Dr --------------------- XB RBC: XB WBC: WL:OFF Open Sampler
Param: 1 Limits: 1
G
WBC K/uL R
NEU %N S A
I N
LYM %L
Z L
MONO %M E R
EOS %E T
BASO %B Y

RBC M/uL COMPLEXITY LOBULARITY


HGB g/dL
HCT %
MCV fL
MCH pg
MCHC g/dL
RDW %

PLT 0.00. K/uL


MPV fL
RBC PLT

CLEAR WORK ANIMAL CUSTOMIZE CHANGE PRINT COLOR MAIN


APERTURES LIST TYPE REPORT SAMPLER TICKET PRINT

Figure 13.15: Customized Display for Adding New Animals

Customizing the Display


Follow the instructions given in Chapter 5: Operating Instructions
for Customizing the Displayed Report. Customize the display as
shown in the preceding figure. Select color printing on the
CUSTOMIZE PRINTED REPORT Screen for the graphics printer.

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Chapter 13 Adding New Animal Types

Turning on the Gains Template


Follow the instructions below for turning on the Gains template
(refer to the following figure):

1. If necessary from the RUN screen, press [CHANGE SAMPLER] to


select the Open Mode.
2. With the RUN screen displayed, press the F12 key followed by
the F2 key on the keyboard. Boxes and crosses will be
displayed in the scatterplot/histogram section as shown in
the following figure. These tools will assist the user in
computing the adjustment for the gain settings in the SET
POINT ENTRY section.
NOTE: These tools will be displayed on the RUN screen,
the DISPLAY SPECIMEN screen in the DATA LOG, and the
FLAGGING DIAGNOSTICS screen. When turned ON, they are
displayed on all Patient specimen screens, human as well
as animal.

RUN
Next ID ----------- Auto Ready Dec 01 1998 10:20
Animal: HORSE Report for BACKGROUND Operator ID 757
Sex(M/F):-M DOB:--/--/-- Sequence # 4166
Dr --------------------- XB RBC: XB WBC: WL:OFF Open Sampler
Param: 1 Limits: 1
G
R
WBC K/uL S A
NEU %N I N
LYM %L Z L
MONO %M E R
EOS %E T
BASO %B Y

RBC M/uL COMPLEXITY LOBULARITY


HGB g/dL
HCT %
MCV fL
MCH pg
MCHC g/dL
RDW %

PLT 0.00. K/uL


MPV fL RBC PLT

CLEAR WORK ANIMAL CUSTOMIZE CHANGE PRINT COLOR MAIN


APERTURES LIST TYPE REPORT SAMPLER TICKET PRINT

Figure 13.16: Gains Template

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Adding New Animal Types Chapter 13

Preparing the Samples


• Specimen recommendations: Obtain 3 to 5 mL of
appropriately anticoagulated blood from at least 3 to 5
healthy animals of the species to be set up.
• The specimens should be analyzed within six hours of
collection.
• Use specimens from at least two different animals of the
same species to ensure that the scatter populations are
displayed in the same general location.
• Each specimen should have sufficient volume to be run four
times each in the Open Mode. (Specimens are run in
duplicate to compute the adjustment factors and then
repeated to verify the adjustments.)

Running the Samples


1. Run, in duplicate, a minimum of two normal samples from
the species.
2. Obtain a printout after each run. If necessary, refer to the
directions given in Chapter 5: Operating Instructions to
customize the graphics report and select color printing.
3. Save the printouts for use in the next section, Determining
the Variance.

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Chapter 13 Adding New Animal Types

Determining the Variance


Example

0
0

S Target
I Box
Z
E

Neutrophil
Population
Lymphocyte
Population
10 COMPLEXITY
0

Figure 13.17: Target Locations for the Neutrophil and Lymphocyte


populations

The ideal position of the Neutrophil population is shown in


Figure 13.17. Increasing or decreasing the WOC 0° gain setting
moves the population up and down on the 0° axis. Decreasing or
increasing the WOC 10° gain setting moves the population left
and right on the 10° axis.

For example, if the Neutrophil population is located below the


Target Box, increase the WOC 0° gain setting until the population
is centered over the box. If the Neutrophil population is located
above the Target Box, decrease the WOC 0° gain setting until the
population is centered over the box. If the Neutrophil population
is located to the left or right of the Target Box, increase or decrease
the WOC 10° gain setting to move the population in the desired
direction on the 10° axis.

NOTE: Remember that the Lymphocyte population will


also move up and down on the 0° axis and left and right
on the 10° axis when the gain settings are increased or
decreased.

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Adding New Animal Types Chapter 13

Estimating the WOC 0° and 10° Adjustments


Worksheets are included at the end of this section. Make copies
as necessary.
To estimate the amount of gain adjustment that may be necessary
to center the population, do the following:
1. Using the first printout, observe the orange Neutrophil
population on the SIZE/COMPLEXITY (0°/10°) scatterplot.
Compare the center of the Neutrophil population to the
center of the template box. (See the preceding figure.) The
population center should be located in the middle of the
template box.
2. Using the marks on the 0° axis as a guide (each mark = 25%
from the apex), estimate the percent needed to move the
center of the population up or down on this axis to center it
in the template box. Write this number in the appropriate
column on the worksheet.
3. Using the marks on the 10° axis as a guide (each mark = 25%
from the apex), estimate the percent needed to move the
center of the population left or right on this axis to center it
in the template box. Write this number in the appropriate
column on the worksheet.
4. Repeat steps 1 through 3 above for the second printout (and
any additional printouts) obtained under Running Samples
above.
5. On each of the printouts, locate the blue Lymphocyte
population on the SIZE/COMPLEXITY scatterplot. Compare
the center of the Lymphocyte population to the center of
the cross. (You will not be able to directly shift the
Lymphocyte population. It will move as the Neutrophil
population is shifted.)
6. Average the estimated 0° adjustments. The resulting figure
is the percent adjustment (variance) for the 0° axis. Write
this number in the appropriate column on the worksheet.
7. Average the 10°estimated adjustments. The resulting figure
is the percent of adjustment necessary for the 10° axis.
Write this number in the appropriate column on the
worksheet.
8. Enter the average variances in the appropriate boxes on the
second chart on the worksheet.
9. For a description of the procedure for adjusting gain
settings, refer to Entering New Gain Settings later this
section.

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Chapter 13 Adding New Animal Types

Estimating the WOC 90° and 90° Depolarized Adjustments


To estimate the amount of gain adjustment that may be necessary
to center the population, do the following:
NOTE: Retain the sign for the adjustment and the final
variance.

1. Using the first printout, observe Neutrophil population on


the GRANULARITY/LOBULARITY scatterplot. Compare the
center of the Neutrophil population to the center of the
cross. (See Figure 13.16.) The population center should be
located on the center of the cross.
2. Using the marks on the 90°depolarized axis as a guide (each
mark = 25% from the apex), estimate the percent needed to
move the center of the population up or down (+ or -) on
this axis to center it on the cross. Write this number in the
appropriate column on the worksheet.
3. Using the marks on the 90°axis as a guide (each mark = 25%
from the apex), estimate the percent needed to move the
center of the population left or right (- or +) on this axis to
center it on the cross. Write this number in the appropriate
column on the worksheet.
4. Repeat steps 1 through 3 above for the second printout (and
any additional printouts) obtained under Running Samples
above.
5. Average the 90° depolarized estimated adjustments. The
resulting figure is the percent adjustment (variance) for the
90° depolarized axis. Write this number in the appropriate
column on the worksheet.
6. Average the 90° estimated adjustments. The resulting figure
is the percent adjustment (variance) for the 90° axis. Write
this number in the appropriate column column on the
worksheet.
7. Enter the average variances in the appropriate boxes on
Chart 2 on the worksheet.
8. For a description of the procedure for adjusting gain
settings, refer to Entering New Gain Settings later this
section.

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Adding New Animal Types Chapter 13

RBC and PLT Histogram Adjustments


To estimate the amount of gain adjustment that may be necessary
to center the population, do the following:
NOTE: Retain the sign for the adjustment and the final
variance.

1. Using the first printout, observe the peak of the RBC


histogram in relation to the vertical center of the rectangle.
(See Figure 13.16.) The RBC histogram peak should be
centered on the vertical center of the rectangle.
2. Using the marks on the x-axis as a guide (each mark = 50
channels) determine the present channel and the desired
channel. Use the following formula to estimate the percent
needed to move the peak of the histogram left (-) or right (+)
to center it in the rectangle.
Formula:
Variance = Desired Channel - Present Channel
X 100
Present Channel
Write this number in the appropriate column on the
worksheet.
3. Repeat steps 1 and 2 above for the second printout (and any
additional printouts) obtained under Running Samples
above.
4. Average the RBC estimated adjustment. The resulting figure
is the percent of adujstment (variance) necessary to center
the RBC histogram. Write this number in the appropriate
column on the worksheet.
5. Repeat steps 1 through 4 above for the PLT histogram.
6. For a description of the procedure for adjusting gain
settings, refer to Entering New Gain Settings later this
section.

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Chapter 13 Adding New Animal Types

Computing the New Gain Settings


1. Press the [MAIN] soft key followed by [DIAGNOSTICS] to
display the main DIAGNOSTICS menu.
2. Press the F12 key followed by the F1 key on the keyboard to
display the SET POINT ENTRY screen. (See the following
figure.)
NOTE: Be sure the appropriate animal type is displayed
in the upper left corner of the screen.
3. Press the PRINT SCREEN key on the keyboard to obtain a
copy of the current gain settings.
4. Record the current gain settings in the appropriate boxes on
the second chart on the worksheet.
5. Compute the adjustment factors as follows:

Adjustment Factor = Current Setting X Average Variance

NOTE: Be certain to retain the sign of the Adjustment


Factor.

6. Compute the new settings as follows:

New Setting = Current Setting ± Adjustment Factor

NOTE: If the Adjustment Factor has a negative sign,


subtract it from the current setting.

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Adding New Animal Types Chapter 13

Animal: CAT SET POINT ENTRY Dec 01 1998 13:24


Ready Operator ID 732
Sequence # 3954

Gains: WOC 0D 1769


WOC 10D 1369
WOC 90D 3069
WOC 90DP 2825
RBC 2684
PLT 4095
WIC 3765
Current
HGB 1700
THRESH:
WOC 320 RBC 3291
RBC 240 WIC 3000
PLT lo 396
PLT hi 4095
WIC lo 480
WIC hi 4095

SET RETURN
ANALYZER

296 B 4
Figure 13.18: Set Point Entry Screen

Entering the New Settings


CAUTION: Only change the settings for the six
parameters to shift the population centers. Do not change
any of the other settings on the SET POINT ENTRY screen.

1. For each parameter that needs adjustment, increase or


decrease the gain setting with the adjustment factor to
center the population.
2. Press [SET ANALYZER] to save the new settings.
NOTE: The analyzer must be in the Ready state to save
changes.

3. Press the Print Screen key on the keyboard to obtain a


printout of the new gain settings.

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Chapter 13 Adding New Animal Types

Verifying the New Settings


NOTE: Retaining a hard copy of each animal gain settings
and storing these settings on the Setup-disk is
recommended. To save the gain settings on the Set-up
disk, refer to the Post-Calibration Procedures Section in
Chapter 6.

1. Press [MAIN] followed by [RUN] to return to the RUN screen.


2. Using a specimen from the second animal, run a minimum
of 2 samples and observe the WBC population centers on
the scatterplots and the RBC/PLT peaks on the histograms.
3. Check the MCVs and MPVs on the repeat runs. If necessary,
calculate new factors as follows:
If the RBC gain or set point entry was changed, a new MCV
Calibration Factor must be calculated as follows:
Default RBC Gain X Current Default MCV Cal Factor = New MCV Factor
Animal RBC Gain

If the platelet gain or set point entry was changed, a new


MPV Calibration Factor must be calculated as follows:
Default PLT Gain X Current Default MPV Cal Factor = New MPV Factor
Animal PLT Gain

4. If all gain adjustments were successful, continue processing


animal samples. If additional adjustments are necessary,
repeat the appropriate procedure for identifying and
correcting variances for WOC, RBC, or PLT as described
above.

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Adding New Animal Types Chapter 13

Baso Box Setup


The Baso Box setup is used to make an adjustment to the 0°/10°
scatterplot when lymphs, monos, or noise is being included in the
basophil count.

1. From the MAIN MENU screen, press [SET UP].


2. From the SET UP menu, press [ANIMAL SET UP].
3. Press F12 - F1 to access the Baso Box Settings.
These settings must be determined for each species (see the
following figure):
1. Standard Deviation along Lymph/Neut Centerline
to Baso Box. (If lymphs are being called basophils,
increase #1 SD.)
2. Standard Deviation from Centerline to Baso Box
Upper Line. (If monos are being called basophils,
decrease #2 SD.)
3. Standard Deviation from Centerline to Baso Box
Lower Line. (If noise is entering baso area, decrease
#3 SD.)
4. Standard Deviation along Centerline to Noise Cut.
(#1 and #4 should be moved the same number of
SDs.)

M
S E
I 2
Z
o
as

E
B

3
1
L
Legend:
N = Neutrophil
4 L = Lymphocyte
M = Monocyte
E = Eosinophil
COMPLEXITY Baso = Basophil

Figure 13.19: Baso Box Set Up

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Chapter 13 Adding New Animal Types

Adding New Animals


Worksheet
Instrument: __________________________________ Date:______________________________________
Operator: ____________________________________ Animal:____________________________________

Chart 1: Variance Estimation


WOC 0° WOC 10° WOC 90°D WOC 90° RBC PLT
Sample Estimated Estimated Estimated Estimated Estimated Estimated
ID# Adjustment Adjustment Adjustment Adjustment Adjustment Adjustment

Sum
N
Average
Variance

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Adding New Animal Types Chapter 13

Adding New Animals Worksheet

Chart 2: Calculating New Settings


Current Average Adjustment Current New
Parameter Setting x Variance = Factor ± Setting = Setting
WOC 0D
WOC 10D
WOC 90D
WOC 90DP
RBC
PLT

Chart 3: Verification Run — Variance Confirmation


Sample WOC WOC WOC WOC RBC PLT
ID# 0° Variance 10° Variance 90°D Variance 90° Variance Variance Variance

Sum
N
Average
Variance
Variance
Limit ±5% ±5% ±5% ±5% ±5% ±5%

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Chapter 13 Vet Package Suggestions

Vet Package Suggestions

Some species require special consideration when preparing or


running samples.

Avian and Reptile Species


1. If only a small amount of specimen is available, dilute it with
diluent to obtain sufficient specimen for processing.
(Remember to multiply the results by the dilution factor to
obtain correct values.
2. Specimens for these species should not be drawn in EDTA,
but in Sodium Citrate or Lithium Heparin. (Remember to
multiply by the dilution factor if using Sodium Citrate.)
3. ALL bird and reptile specimens are to be run in Resistant
RBC. If the RBCs continue to interfere with the WBC and
Differential results, make a 1:4 dilution with Sheath reagent
and run within 30 seconds. If Sheath is used to make the
dilution, the RBC and Platelet parameters are not valid.

Mice
Since only small amounts of specimen are available, make a
dilution with diluent in order to have enough specimen for
processing.

Multiply the results by the dilution factor to obtain correct values.

Goats, Sheeps, Llamas, and Other Mammals with Red Blood Counts over 10,000
Since the linearity of impedance counts may be questionable for
species with extremely high RBC counts, the RBC count may be
underestimated unless a dilution is made. For example, a 1:2
dilution with diluent may yield more accurate RBC counts and
RBC indices.

The results must be multiplied by the dilution factor.

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Vet Package Suggestions Chapter 13

Examples of Customer-Defined Default Codes


The Vet Package catalog has built-in codes for dog, cat, mouse, and
rat. All other animals must be set up by starting with the default
and then adapting the settings. The chart that follows lists some
different examples of animal default settings that may be set by
individual laboratories. Be sure to set default settings according to
the needs of your own laboratory.
Animal 0 10 90 90D RBC PLT WIC MCV MPV WBC Threshold

African Grey 2.172414 1.569185 1.800365 0.748581 0.672043 1 1 1.294 1 499


Baboon 1.087731 0.984767 1 1.17096 1.172267 1 1 1 1 360
Beluga Whale 1.133031 1.049318 1 1 1 1 1 1.512 1 360
Birds of Prey 1.33515 1.292976 1.519166 0.569043 0.509359 1 1 0.575 1.018 400
Cat 1.542876 1.164875 2.044352 2.046253 1.8624 1.051621 1 0.434 1.018 400
Cat 1.380197 1.078699 1.931829 2.045567 1.722136 1.037313 1 0.491 1.018 400
Cat 1.380197 1.078699 1.931829 2.045567 2.019181 1.037313 1 0.575 1.018 400
Cat 1.38006 1.101079 2.04504 2.046538 1.05126 1 0.575 1.018 400
Cat 1.518741 1.22473 2.454656 2.249716 2.15 1.049957 1 0.465 0.952 400
Catfish 1.236882 2.010795 2.433962 2.26958 1 1 1 1 1 360
Chicken 1.723388 1.373896 1.52039 0.567537 0.758602 1 1 1.26 1 360
Chick2 - 1.874063 1.373896 1.52039 0.567537 0.758065 1 1 1.26 1 299
Chicken 2.307346 1.439647 1.800365 0.748581 1 1 1.488 1 360
Cow 1.380607 1.102151 2.044352 2.046253 1.8624 1.051621 1 0.491 1.018 400
Cow 1.380197 1.078699 1.931829 2.045567 2.122862 1.797191 1 1 1 360
Cow 1.273613 0.939156 1.216677 0.99319 2.15 1.15682 1 0.465 0.864 400
Cow 1.568966 1.206084 2.103469 1.983541 2.15 1.15682 1 0.465 0.864 400
Cyno Monkey 1.137863 1.044803 1 1 1 1 1 0.704 0.772 320
Deer 1.16042 1.128557 1.962264 2.249716 2.15 0.781929 1 0.465 1.279 400
Dog 1.346183 1.095488 1.931829 2.404557 1.384137 1.779631 1.133841 0.97 1 360
Dog 1.415292 1.159961 2.04504 2.26958 1.495161 1.646829 1.133846 0.669 0.607 320
Dog 1 1.311844 1.274779 1.156421 2.213394 1.20808 1.646829 1.133846 0.669 0.607 320
Dog 2 1.424288 1.324828 1.276932 2.213394 1.495161 1.646829 1.133846 0.669 0.607
Dolphin 1 1 1 1.123153 1 1 1 not calc not calc 650
Dolphin 0.991004 0.934249 1.240414 1.045403 1.036559 0.98914 1.008923 1 1 360
Dolphin 1 0.991004 0.934249 1.240414 1.045403 1.036022 0.988705 1.008615 1 1 360
Duck 1.813325 1.366487 1.418687 0.468384 0.973333 0.778584 1 0.97 1 360
Elephant 2.284203 1.929696 1 1.368842 0.94816 1.043898 1 0.491 1.018 400
Emu 1.461019 1.029441 1.52039 0.567537 0.757527 1 1 1.42 1 499
Emu 1.461019 1.029441 1.52039 0.567537 0.756989 1 1 1.42 1 599
Ferret 1.51096 1.520462 2.008337 2.045567 1.86366 1.037313 1 2.47 1 360
Ferret 1.518741 1.22473 2.454656 2.096481 2.15 1.049957 1 0.465 0.952 400
Fish 1.621271 2.276539 2.430295 2.269377 0.404313 1.417096 1 0.97 1 360
Foal 1.446777 1.044161 2.454656 2.250851 2.15 1.433102 1 0.465 0.698 400
Gentoo Penguin 1.437642 0.860441 1.616969 0.570197 0.478486 0.247147 1 not calc. not calc 360
Goat 1.16042 1.128557 1.962264 2.249716 2.15 0.781929 1 0.465 1.279 400
Goat 1.574213 1.274779 1.825928 2.096481 2.15 0.781929 1 0.465 1.279 400
Goat 2 1.16042 1.128557 1.962264 1.829739 2.150538 0.000434 1 0.465 1.279 400
Hamster 0.961741 0.945341 1 1 1 1 1 0.493 0.575 360
Horse 1.51096 1.310598 2.008337 2.520936 2.122343 1.797191 1 0.97 1 360
Horse 1.446777 1.044161 2.454656 2.250851 2.15 1.433102 1 0.465 0.698 400
Horse 2 1.1994 1.177625 23454656 2.250851 2315 13433102 1 0.465 0.698 400
Llama 1.37415 1.426023 1.137813 1.067734 2.122862 1.636962 0.992073 0.97 1 360
Llama 1.49925 1.177625 1.673159 2.213394 2.201613 1.778019 0.861538 0.454 0.562 400
Lizard 2.998501 2.943081 2.433962 1.135074 1 1 0.692308 1 1 360
Macaw 2 2.172414 1.569185 2.433962 0.681044 0.537634 1.433102 0.384615 1.294 1 400
Moray Eel 1.239607 2.010493 2.008337 2.023399 1 1 1 not calc not calc. 360
Mouse 1.054749 0.896057 1 1 2.0256 1.706485 1 0.65 1 360

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Chapter 13 Vet Package Suggestions

Animal 0 10 90 90D RBC PLT WIC MCV MPV WBC Threshold

Ostrich 1.461019 1.029441 1.52039 0.567537 0.757527 1 1 1.42 1 499


Ostrich 1.461019 1.029441 1.52039 0.567537 0.763441 1 1 1.55 1 360
Ostrich 1.461019 1.029441 1.52039 0.567537 0.760215 1 1 1.55 1 360
Ostrich 1.461019 1.029441 1.52039 0.567537 0.760215 1 1 1.42 1 360
Pig 1.383905 1 1.477824 1.462529 2.184 1.194539 1 not calc not calc. 650
Pig 1.415292 1.159961 2.04504 2.26958 1.770968 1.737619 1.133846 0.564 0.576 320
Pig 1- 1.723388 1.668302 2.04504 2.26958 1.769892 1.737619 1.133846 0.564 0.575 320
Pigeon 2.307346 1.439647 1.800365 0.748581 0.672043 1 1 1.488 1 360
Prairie Chicken 1.874063 1.569185 1.52039 0.567537 0.757527 1 1 1.26 1 349
Quail 1.51715 1.253584 1.418687 0.468384 1 1 1 not calc not calc 360
Rabbit 1.154354 0.984767 1.301005 0.789813 1 1 1 0.616 0.62 360
Rabbit 1.504913 1.373557 1.273664 1.163177 1.594609 1.797191 0.992073 not calc not calc 360
Rabbit 1.43928 1.049068 1.455265 0.575482 1.378495 1.099913 1 0.726 0.909 360
Rat 1.384565 1.164875 2.364873 2.34192 1.6 2.97619 1 1 1 360
Rat 1.554723 1.139352 1.339014 2.270148 1.666667 1 1 0.6 0.72 360
Rhesus 1.87335 0.983871 1.063868 1 1 1 1 1 1 360
Sea Turtle 1.535982 1.519136 2.310408 2.26958 1 1 1 1 1 360
Sheep-Goat 1.931784 1.544652 1.946439 0.681044 2.15 1.443962 1 1 1 360
Snake 1.542729 1.668302 2.190505 2.433962 1 1 0.692308 1 1 240
Squirrel Monkey 1 1 1 1 1 1 1

SPECIES 0 10 90 90D RBC PLT WIC MCV WBC RBC

CAL THRES THRES


African Grey 2.74 2.24 2.39 0.63 0.77 0.77 1.41 1.304 1.59 1.00
Budgerigar 2.14 1.49 1.71 0.99 0.50 1.00 1.41 2.047 1.66 1.00
Cockatoo 1.63 1.44 1.20 0.75 0.50 1.00 0.97 1.853 1.66 1.00
Conure 1.81 1.44 1.80 0.75 0.67 0.97 0.94 1.364 1.66 1.00
Great Horned Owl 2.56 1.79 2.73 1.26 0.75 1.00 0.97 1.374 0.83 1.00
Gyrfalcon 1.63 1.44 1.20 0.75 0.50 1.00 0.97 1.364 1.66 1.00
Macaw 1.81 1.44 1.80 0.75 0.67 0.97 0.97 1.364 1.66 1.00
Meyer’s Parrot 2.19 1.49 1.71 0.75 0.50 1.00 0.94 20.47 1.66 1.00
Owl 1.63 1.44 1.20 0.75 0.50 1.00 0.97 1.364 1.66 1.00
Red Tailed Hawk 2.56 1.79 2.73 1.26 0.75 1.00 0.97 1.209 0.83 1.00
Rhea 1.60 1.00 1.50 0.60 0.70 1.00 1.00 1.307 1.00 1.00
Swainson’s Hawk 2.56 1.79 2.73 1.26 0.75 1.00 0.97 1.209 0.83 1.00

CELL-DYN® 3700 System Operator’s Manual 13-51


9140320C — November 2000
Veterinary Package
Vet Package Suggestions Chapter 13

NOTES

13-52 CELL-DYN® 3700 System Operator’s Manual


9140320D — June 2003
Chapter 13 Veterinary Package

Turning The Vet Package Off

When the Veterinary Package software is turned OFF, the


instrument automatically returns to the original human settings
and runs three background cycles to rinse the instrument.

Procedure: Turn Vet Package OFF


NOTE: The instrument must be in the Open Mode in
order to exit the Vet Package.

1. From the MAIN MENU screen, press [SET UP] followed by


[OPERATION SET UP].
2. From the OPERATION SET UP MENU screen, press [TURN VET
PKG OFF] to disable the veterinary software.
NOTE: The key label changes to [TURN ON VET PKG] when
the Vet Package is deselected.

The instrument automatically returns to the original human


settings and runs three background cycles. The Status Box
displays the message RINSING THE ANALYZER and the
Bulletin Line displays the message: Please wait while
the analyzer is rinsed.
3. Verify that the background count is acceptable on the last
cycle. If the background count is not acceptable,
troubleshoot accordingly as directed in Chapter 10:
Troubleshooting.
4. Quality Control samples should be run in the human mode
before processing samples. Follow the instructions given in
Chapter 5: Operating Instructions, Subsection: Daily Quality
Control.

CELL-DYN® 3700 System Operator’s Manual 13-53


9140320C — November 2000
Veterinary Package
Turning The Vet Package Off Chapter 13

NOTES

13-54 CELL-DYN® 3700 System Operator’s Manual


9140320C — November 2000
Chapter 13 Veterinary Package

References

1. Specifications for rats and mice were obtained from a study


conducted between December 1993 and May 1994 by Dr. H.
Lutz at the Facility of Veterinary Medicine, University
Zurich, Zurich, Switzerland.

CELL-DYN® 3700 System Operator’s Manual 13-55


9140320C — November 2000
Veterinary Package
References Chapter 13

NOTES

13-56 CELL-DYN® 3700 System Operator’s Manual


9140320C — November 2000
Reticulocyte Package
Chapter 14 Overview

Reticulocyte Package

Overview

The Reticulocyte Package software enables the operator of the


CELL-DYN 3700 System to analyze a whole blood specimen for
reticulocytes. The Reticulocyte specimen is prepared by using
reticulocyte reagent to produce a diluted, stained sample.
Reticulocyte specimens can be run as batches up to two hours
after preparation, or they can be run on a STAT basis.
The Reticulocyte Package is enabled by pressing [TURN ON RETIC
PKG] from the OPERATION SET UP MENU screen.
Each menu and function is modified when used in the
Reticulocyte Package. Therefore, some of the soft keys that are
displayed in the Standard Hematology Mode will be available
from the different Reticulocyte screens, and some will not. A
Reticulocyte Data Log and a Reticulocyte QC Log are available for
samples and controls run within the Reticulocyte Package.
Descriptions of all Reticulocyte soft keys are included in this
chapter.

The prepared specimen run with the Reticulocyte Package on the


CELL-DYN 3700 System will measure results as a reticulocyte
percentage. The reticulocyte absolute number is automatically
calculated when the RBC value is made available from the
Standard Hematology Data Log or entered by the operator. The
Immature Reticulocyte Fraction (IRF) is calculated from the
Reticulocyte % and displayed below the Reticulocyte absolute
number.

The CELL-DYN 3700 System can be returned to the Standard


Hematology function by pressing [TURN OFF RETIC PKG] from the
OPERATION SET UP MENU screen.

CELL-DYN® 3700 System Operator’s Manual 14-1


9140320D — June 2003
Reticulocyte Package
Overview Chapter 14

Chapter Contents

This chapter contains the following subsections:


• Principles of Operation
• Retic Menu Options
• Turning the Reticulocyte Package ON and OFF
• All Retic Menus Except the Retic Run Menu
• Routine Operation
• Retic Run Menu
• Reticulocyte Specimens
• Quality Control Guide
• Maintenance
• Troubleshooting

14-2 CELL-DYN 3700® System Operator’s Manual


9140320C — November 2000
Reticulocyte Package
Chapter 14 Overview

Flowchart Conventions
Menus are shown as square-cornered rectangles in the flowcharts,
and soft keys are shown as round-cornered rectangles:

MAIN MENU
Ready

SET UP RUN DATA LOG RETIC QUALITY


DATA LOG CONTROL

When procedures are depicted in flowcharts, shaded boxes and


bold lines indicate which soft keys to press:

MAIN MENU
Ready

SET UP RUN DATA LOG RETIC QUALITY


DATA LOG CONTROL

PATIENT REAGENT QC SET OPERATION


LIMITS LOG UP MENU SET UP

TURN ON TURN ON BAR CODE


VET PKG RETIC PKG SET UP

Flowcharts
The Reticulocyte Package master menu flowchart on the following
page was designed to help guide the operator quickly and easily
through the menu levels and soft key functions used in the
Reticulocyte Package. A segment of this flowchart is included at
the beginning of each submenu description to guide the operator
through the levels and functions of each submenu and back again
to the MAIN MENU. The master menu flowchart can be used as a
pull-out guide.

CELL-DYN® 3700 System Operator’s Manual 14-3


9140320D — June 2003
Reticulocyte Package
Overview Chapter 14

NOTES

14-4 CELL-DYN 3700® System Operator’s Manual


9140320C — November 2000
RETIC MAIN
Ready
CELL-DYN® 3700 System
Reticulocyte Menu Flowchart
RETIC RETIC RETIC DATA RETIC RETIC RETIC SP
SET UP RUN DATA LOG LOG QC LOG DIAGNOSTC PROTOCOLS
Chapter 14

RETIC SPECIAL PROTOCOLS


Ready
RETIC RUN
Ready
FLUSH EMPTY CLEAN DISABLE RETIC
SHEATH WOC SHEAR VLV ANALYZER MAIN
FILL RESTORE ENABLE
PATIENT QC BACK- RETIC WOC SHEAR VLV ANALYZER

9140320C — November 2000


SPECIMEN SPECIMEN GROUND MAIN
RETIC DIAGNOSTICS
Ready

CELL-DYN® 3700 System Operator’s Manual


NEXT PRINT RETURN
RETIC REPORT
FAULT RETIC CNT CLEAR RAW DATA INITIAL- PRINT RETIC
REPORT RATE SUMM FAULT SUMMARY IZATION MAIN

NEXT PRINT RETURN


RETIC REPORT
RETIC PRINT RETURN PRINT RETURN
CNT GRAPH
RETIC SET UP RETIC
Ready NEXT PRINT RETURN CNT RATE
RETIC REPORT

RETIC QC LOG
RETIC PT RETIC QC OPERATION RETIC RETIC Ready
LIMITS SET UP SET UP UNITS MAIN

USA SI SI MOD SET 1 SET 2 SELECT RETURN VIEW RETIC RETIC RETIC
UNITS UNITS UNITS UNITS UNITS UNITS QC LOG QC LIMITS SET UP QC MAIN

TURN OFF BAR CODE COMPUTER RETURN RETIC DATA LOG TOGGLE PRINT RETURN
RETIC PKG SET UP SET UP Ready ON/OFF

RETIC RETIC RETURN RANGE PRINT RETURN


QC LIMITS SET UP QC EDIT DISPLAY FIND TRANSMIT PRINT RETIC ENTRY
ID SPECIMEN SPECIMEN DATA DATA LOG MAIN MEANS/
LIMITS
TOGGLE PRINT RETURN
ON/OFF
RETURN
PURGE LEVEY- REJECT DELETE MOVE PRINT RETURN
QC LOGS JENNINGS SPECIMEN SPECIMEN SPECIMEN QC LOG
ACCEPT
RANGE PRINT RETURN SPECIMEN
ENTRY PREVIOUS NEXT EDIT TRANSMIT PRINT RETURN
MEANS/ SPECIMEN SPECIMEN SPECIMEN SPECIMEN REPORT MOVE CANCEL
CONFIRM CANCEL TO FILE MOVE
LIMITS PURGE PURGE

LIMIT LIMIT LIMIT LIMIT PRINT RETURN CONFIRM CANCEL CONFIRM CANCEL
SET 1 SET 2 SET 3 SET 4 NEXT PREVIOUS PRINT RETURN DELETION DELETION
*

10 10
* DISPLAYED WHEN MORE THAN 30 RESULTS ARE IN THE FILE.
Overview
Reticulocyte Package

14-5
Reticulocyte Package
Overview Chapter 14

NOTES

14-6 CELL-DYN 3700® System Operator’s Manual


9140320C — November 2000
Reticulocyte Package
Chapter 14 Principles of Operation

Principles of Operation

The Reticulocyte Package software is designed to configure the


instrument to process stained, diluted specimens. When the
Reticulocyte Package is turned ON, the instrument automatically
selects the appropriate configuration file and adjusts the
instrument settings to the values in this file. This configuration is
retained until the Reticulocyte Package is turned OFF. The
instrument then returns to the Standard Hematology settings.
Reticulocytes are defined by the Clinical and Laboratory
Standards Institute (formerly NCCLS) as transitional red cells,
between nucleated red cells and the so-called mature
erythrocytes1. In contrast to mature RBCs, reticulocytes contain
ribosomal RNA. This RNA can be seen with certain supravital,
cationic dyes that simultaneously stain and precipitate the
polyanion to form a network or reticulum. The CELL-DYN 3700
System reticulocyte method uses the thiazine dye New Methylene
Blue N. The reticulocyte assay is performed in the WOC channel
of the instrument. Sample preparation is performed manually by
diluting 20 µL of blood into a tube of CELL-DYN Reticulocyte
Reagent. At room temperature, staining of reticulum is complete
within approximately 15 minutes. The stained sample is aspirated
in the Open Mode. After the stained sample is aspirated, it is
diluted approximately 50-fold with Sheath Reagent. Once diluted
with Sheath, the RBCs sphere due to the influence of the
nonionic detergent incorporated into the staining solution.
Sphering is necessary to eliminate optical orientational noise that
would otherwise be introduced into the scatter measurements.
The usual lytic action of the Sheath is prevented by electrolytes
contained in the staining solution and the lack of the usual
incubation period used in this channel during WBC analysis. In
addition, the high New Methylene Blue concentration in the
staining reagent exerts a stabilizing effect on RBCs.
During data acquisition, 10 degree and 90 degree scatter are
collected for up to 30,000 events. The 0 degree threshold is set
high enough to exclude most platelets. Histogram data are used
to differentiate reticulocytes, mature RBCs, platelet clumps, and
nucleated cells. Reticulocytes have 10 degree scatter that are
similar to the scatter for mature RBCs, but differ from them by
exhibiting greater 90 degree scatter. Reticulocytes are reported in
percent. The instrument will automatically calculate the
Reticulocyte Absolute value if an RBC count is entered.

CELL-DYN® 3700 System Operator’s Manual 14-7


9140320F — April 2007
Reticulocyte Package
Principles of Operation Chapter 14

The RBC value may be obtained from the Standard Hematology


Data Log, or it may be entered by the operator directly on the
RETIC PATIENT SPECIMEN screen.

Immature reticulocytes contain more RNA and absorb more stain


than mature reticulocytes; therefore, they exhibit greater 90
degree scatter. On the CELL-DYN 3700, immature reticulocytes are
classified as the population of reticulocytes that exceed a
predetermined scatter threshold. Consequently, it is possible to
determine the Immature Reticulocyte Fraction (IRF) from the
scatter measurements.

The IRF was initially designated as the Reticulocyte Maturation


Index (RMI), and defined by CLSI/NCCLS H44-A21 as a
quantitative expression of the maturation state of the entire
reticulocyte population in the peripheral blood. Since automated
reticulocyte methods allow the enumeration of immature
reticulocytes as a subfraction of the total reticulocyte population,
the preferred nomenclature is Immature Reticulocyte Fraction
(IRF). The immature reticulocytes are then reported as a fraction
(or percent) of the reticulocytes.
The clinical utility2 of the IRF is widely recognized as follows:
• Monitor hemopoietic regeneration after bone marrow
transplant, hemopoietic stem cell transplantation, or
intensive chemotherapy
• Monitor bone marrow toxic insults from drugs (for example,
AZT)
• Monitor erythropoietin therapy in renal failure, AIDS,
infants, myelodysplastic syndromes, and blood donations
• Classify anemia
• Monitor efficacy of anemia therapy (Fe, B12, Folate)

14-8 CELL-DYN 3700® System Operator’s Manual


9140320F — April 2007
Reticulocyte Package
Chapter 14 Retic Menu Options

Retic Menu Options

This section discusses the operation of the Reticulocyte Package. It


contains the following subsections:

• Turning the Reticulocyte Package ON and OFF


• Retic Main Menu
• Retic Set Up Menu
• Retic Data Log Menu
• Retic QC Log Menu
• Retic Diagnostics Menu
• Retic Special Protocols Menu
For information about the RETIC RUN menu, refer to Routine
Operation, Retic Run Menu later in this chapter. For specific
instructions about running Reticulocyte specimens, refer to
Routine Operation, Reticulocyte Specimens later in this chapter.

CELL-DYN® 3700 System Operator’s Manual 14-9


9140320C — November 2000
Reticulocyte Package
Retic Menu Options Chapter 14

Turning the Reticulocyte Package ON and OFF


Turning ON the Reticulocyte Package
The [TURN ON RETIC PKG] key is located on the OPERATION SET UP
TURN ON
RETIC PKG MENU screen (see the following figure), which is accessed from the
TURN OFF SET UP screen. The Reticulocyte Package software is enabled when
RETIC PKG the [TURN ON RETIC PKG] key is pressed, and the soft key label
changes to [TURN OFF RETIC PKG]. When the Reticulocyte Package
is ON, the soft keys are displayed as described in this chapter.

OPERATION SET UP MENU Mar 22 1998 16:10


Operator ID sy
Ready
Sequence # 123

To turn on the RETIC PKG you must enter the operator ID and the
instrument must be in Open mode. To turn on the VET PKG you must
exit the RETIC PKG.

TURN ON TURN ON BAR CODE COMPUTER RETURN


VET PKG RETIC PKG SET UP SET UP

Figure 14.1: Operation Set Up Menu Screen with Reticulocyte Package


Disabled

14-10 CELL-DYN 3700® System Operator’s Manual


9140320C — November 2000
Reticulocyte Package
Chapter 14 Retic Menu Options

MAIN MENU
Ready

SET UP RUN DATA LOG RETIC QUALITY CALIBRA- DIAGNOSTICS SPECIAL


DATA LOG CONTROL TION PROTOCOLS

DATE/ PATIENT REAGENT QC SET OPERATION UNITS CUSTOMIZE MAIN


TIME LIMITS LOG UP MENU SET UP SELECTION REPORT

TURN ON TURN ON BAR CODE COMPUTER RETURN


VET PKG RETIC PKG SET UP SET UP

RETIC PT RETIC QC OPERATION RETIC RETIC


LIMITS SET UP SET UP UNITS MAIN

Procedure: Turning ON the Reticulocyte Package


1. From the MAIN MENU, press the [SET UP] key followed by the
[OPERATION SET UP] key to display the OPERATION SET UP
MENU screen.
2. From the OPERATION SET UP MENU screen, press the [TURN ON
RETIC PKG] key to enable the Reticulocyte Package.
NOTE: The key label changes to the [TURN OFF RETIC PKG]
key when the Reticulocyte Package has been enabled.

3. Press the [RETURN] key to display the RETIC SET UP screen.


Then press the [RETIC MAIN] key to display the RETIC MAIN
menu screen.
The software to analyze reticulocytes is now enabled on the
CELL-DYN 3700 System.

CELL-DYN® 3700 System Operator’s Manual 14-11


9140320C — November 2000
Reticulocyte Package
Retic Menu Options Chapter 14

Turning OFF the Reticulocyte Package


The [TURN OFF RETIC PKG] key is located on the RETIC OPERATION
TURN OFF
RETIC PKG SET UP MENU screen (see the following figure), which is accessed
from the RETIC SET UP screen. The Reticulocyte Package software
is disabled when the [TURN OFF RETIC PKG] key is pressed, and the
soft key label changes to [TURN ON RETIC PKG]. When the
Reticulocyte Package is OFF, the soft keys are displayed as
described in Chapter 5: Operating Instructions.

Mar 22 1998 14:10


OPERATION SET UP MENU
Operator ID sy
Ready
Retic Seq# R123

TURN OFF BAR CODE COMPUTER RETURN


RETIC PKG SET UP SET UP

Figure 14.2: Operation Set Up Menu Screen with Reticulocyte Package


Enabled

When the Reticulocyte Package is turned OFF, the instrument


automatically runs three wash cycles before returning to the
Standard Hematology Mode.
CAUTION: If the instrument has been idle for four hours,
it enters the STANDBY state and automatically returns to
the Standard Hematology mode without running a
cleaning cycle. If this happens, perform an Auto-Clean
cycle before using the instrument again.

14-12 CELL-DYN 3700® System Operator’s Manual


9140320C — November 2000
Reticulocyte Package
Chapter 14 Retic Menu Options

MAIN MENU
Ready

RETIC RETIC RETIC RETIC RETIC RETIC SP


DATA LOG DIAGNOSTC
SET UP RUN DATA LOG QC LOG PROTOCOLS

RETIC PT RETIC QC OPERATION RETIC RETIC


LIMITS SET UP SET UP UNITS MAIN

TURN OFF BAR CODE COMPUTER RETURN


RETIC PKG SET UP SET UP

Procedure: Turning OFF The Reticulocyte Package


1. From the RETIC MAIN menu screen, press the [RETIC SET UP]
key followed by the [OPERATION SET UP] key to display the
OPERATION SET UP MENU screen.
2. From the OPERATION SET UP MENU screen, press the [TURN
OFF RETIC PKG] key to disable the Reticulocyte Package. The
instrument automatically rinses, runs three backgrounds,
and returns to the Standard Hematology Software.
NOTE: The key label changes to [TURN ON RETIC PKG] when
the Reticulocyte Package has been disabled.

3. Press the [RETURN] key to display the MAIN MENU.


The software to analyze reticulocytes is now disabled on the
CELL-DYN 3700 System.

CELL-DYN® 3700 System Operator’s Manual 14-13


9140320C — November 2000
Reticulocyte Package
Retic Menu Options Chapter 14

Retic Main Menu

Aug 16 2004 14:10


Version 1.1 CD 3700SL RETIC MAIN Operator ID sy
Ready Retic Seq# R123

RETIC RETIC RETIC DATA LOG RETIC RETIC RETIC SP


SET UP RUN DATA LOG QC LOG DIAGNOSTC PROTOCOLS

Figure 14.3: Reticulocyte Main Menu Screen

The upper left-hand corner of the RETIC MAIN menu screen shows
the current revision of the instrument system. The upper right-
hand corner shows the current date and time, the current operator
ID, and the Reticulocyte Sequence Number. The information in
the upper right-hand corner is displayed on every screen during
operation of the Reticulocyte Package.

The Status Box is displayed in the top center of the screen. This
box appears on every screen to show the following information:

• Menu in use (such as RETIC MAIN)


• Analyzer status (such as Ready)
• Other applicable information (such as report or file identity
and any existing fault conditions)

14-14 CELL-DYN 3700® System Operator’s Manual


9140320E — September 2004
Reticulocyte Package
Chapter 14 Retic Menu Options

The cursor is positioned at the <OPERATOR ID> field when the


RETIC MAIN menu screen is displayed. An operator ID of up to
three alphanumeric characters can be entered. Press the Enter key
on the keyboard to accept this operator ID. This operator ID will
be displayed on all other Reticulocyte Package screens and printed
on all reports.

The following soft key labels are displayed on the RETIC MAIN
menu screen:

RETIC SET UP
RETIC RUN
RETIC DATA LOG
DATA LOG
RETIC QC LOG
RETIC DIAGNOSTC
RETIC SP PROTOCOLS

The RETIC RUN menu is described in Routine Operation later in


this chapter.

CELL-DYN® 3700 System Operator’s Manual 14-15


9140320C — November 2000
Reticulocyte Package
Retic Menu Options Chapter 14

Retic Set Up Menu

RETIC MAIN
Ready

RETIC SET UP
Ready

RETIC PT RETIC QC OPERATION RETIC RETIC


LIMITS SET UP SET UP UNITS MAIN

RETIC RETIC TURN OFF BAR CODE COMPUTER


QC LIMITS SET UP QC RETIC PKG SET UP SET UP

MEANS/ RANGE
LIMITS ENTRY

Mar 22 1998 14:10


RETIC SET UP sy
Operator ID
Ready Retic Seq# R123

RETIC PT RETIC QC OPERATION RETIC RETIC


LIMITS SET UP SET UP UNITS MAIN

Figure 14.4: Reticulocyte Set Up Screen

14-16 CELL-DYN 3700® System Operator’s Manual


9140320C — November 2000
Reticulocyte Package
Chapter 14 Retic Menu Options

The following soft keys are displayed on the RETIC SET UP menu
screen:

RETIC PT LIMITS
RETIC QC SET UP
OPERATION SET UP
RETIC UNITS
RETIC MAIN

These soft keys are described in this section as they appear from
left to right on the screen.

Retic Patient Limits Soft Key

RETIC PT
The [RETIC PT LIMITS] key is used to display the RETIC PATIENT
LIMITS LIMITS screen (see the following figure). The following soft key
labels are displayed on the RETIC PATIENT LIMITS screen:

LIMIT SET 1*
LIMIT SET 2
LIMIT SET 3
LIMIT SET 4
PRINT
RETURN

*The soft key label for whichever limit set is displayed on the
screen is not shown.

CELL-DYN® 3700 System Operator’s Manual 14-17


9140320C — November 2000
Reticulocyte Package
Retic Menu Options Chapter 14

Mar 22 1998 14:10


RETIC PATIENT LIMITS Operator ID lyn
Ready Retic Seq# R123

LIMIT SET 1

Lower Limits Upper Limits

RETIC% 1.06 % 2.64 %

RETIC ABS 10 K/uL 140 K/uL

RBC 4.04 M/uL 6.13 M/uL

IRF 0.01 0.25

LIMIT LIMIT LIMIT PRINT RETURN


SET 2 SET 3 SET 4

Figure 14.5: Reticulocyte Patient Limits Screen

The [RETIC PT LIMITS] key is used to enter upper and lower flagging
limits for groups of patient samples. (For example, limits may be
entered for adult males, adult females, neonates, etc.)
Four sets of limits may be entered. Whenever a result falls outside
an entered limit, the result is displayed in color on the screen to
alert the operator. Results displayed in yellow are below the limit
and results displayed in purple are above the limit. The flagged
result is underlined on the graphics report and in the Reticulocyte
Data Log when printed. Patient results that exceed the linearity
specifications will be suppressed and chevrons (>>>>) will be
displayed and printed.

Procedure: Enter Retic Patient Limits


1. From the RETIC SET UP screen, press the [RETIC PT LIMITS] key
to display the RETIC PATIENT LIMITS screen. A patient limit set
is displayed on the screen. The other three limit sets (Limit
Set 2, Limit Set 3, etc.) may be displayed by pressing the
appropriate soft keys.

14-18 CELL-DYN 3700® System Operator’s Manual


9140320C — November 2000
Reticulocyte Package
Chapter 14 Retic Menu Options

2. Use the arrow keys on the keyboard to move the cursor to the
desired limit entry field and type the desired number. Press
the Enter key on the keyboard to save the entry.
3. Repeat step 2 until all desired entries have been made.
4. If desired, press the [PRINT] key to obtain a printout of the
Limit Set being displayed.
NOTE: Retaining a hard copy of each Limit Set is
recommended, as the screens do not display names or
categories for the Limit Sets.

5. Press the appropriate soft key to select another Limit Set and
repeat steps 2– 4 to enter the desired limits.
6. Press the [RETURN] key to return to the RETIC SET UP menu.

Retic QC Set Up Soft Key

Mar 22 1998 14:10


RETIC QC SET UP
Operator ID sy
Ready
Retic Seq# R123

File Name # Specimens

1. FILE 1 0
2. FILE 2 0
3. FILE 3 0
4. FILE 4 0
5. FILE 5 0
6. FILE 6 0

Press arrow key to select RETIC QC FILE at cursor position.

RETIC RETIC RETURN


QC LIMITS SET UP QC

Figure 14.6: Reticulocyte QC Set Up Screen

CELL-DYN® 3700 System Operator’s Manual 14-19


9140320C — November 2000
Reticulocyte Package
Retic Menu Options Chapter 14

The [RETIC QC SET UP] key is used to display the QC files and the
RETIC QC
SET UP RETIC QC SET UP screen (see the preceding figure). The following
soft key labels are displayed on the RETIC QC SET UP screen:

RETIC QC LIMITS
RETIC SET UP QC
RETURN

This section discusses the procedures that are used to set up the
Reticulocyte QC files. The keys are discussed in the order in which
they are used to set up the QC files. Use the arrow keys on the
keyboard to move the cursor to the desired QC file shown on the
RETIC QC SET UP screen, then type in the desired alphanumeric file
name. (Up to 12 characters may be entered.) Press the Enter key on
the keyboard to save the entry and advance the cursor to the next
QC file. Use the arrow keys to move the cursor back into the
selected file. Then press the [RETIC QC LIMITS] key or the [RETIC SET
UP QC] key to continue to set up the QC file.

Retic QC Limits Soft Key

RETIC QC
The [RETIC QC LIMITS] key is used to display the RETIC QC RANGE
LIMITS ENTRY screen or the RETIC QC MEANS/LIMITS screen, and the
following soft key labels:
MEANS/LIMITS or
RANGE ENTRY (This key label alternates between
these two selections.)
PRINT
RETURN

14-20 CELL-DYN 3700® System Operator’s Manual


9140320C — November 2000
Reticulocyte Package
Chapter 14 Retic Menu Options

RETIC QC RANGE ENTRY Mar 22 1998 14:10


Operator ID lyn
Ready
For FIle 1 Retic Seq# R123

Lower Limit Upper Limit

RETIC % 4 6

IRF 0.47 0.77

MEANS / PRINT RETURN


LIMITS

Figure 14.7: Retic QC Range Entry Screen

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Mar 22 1998 14:10


RETIC QC MEANS/LIMITS Operator ID sy
Ready Retic Seq# R123
For File 1

Means Limits (+/-)

RETIC% 5 1

IRF 0.62 0.15

RANGE PRINT RETURN


ENTRY

Figure 14.8: Retic QC Means/Limits Screen

QC Limits are entered by selecting the QC file from the RETIC QC


SET UP screen (by moving the cursor to the desired QC file) and
pressing the [RETIC QC LIMITS] key. The RETIC QC MEANS/LIMITS
screen is now displayed.

Two types of QC limits are available:

Range Entry This option is used to enter the upper


and lower flagging limits as absolute
numbers.
Means and Limits This option is used to enter the mean
value and a + range value that defines
the upper and lower flagging limits.

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If Range Entry is selected by pressing the [RANGE ENTRY] key, the


RANGE
ENTRY current upper and lower limits for the selected file are displayed as
shown in Figure 14.7, Retic QC Range Entry Screen.

MEANS/
If Means/Limits Entry is selected by pressing the [MEANS/LIMITS]
LIMITS key, the current means and limits for the selected file are displayed
as shown in Figure 14.8, Retic QC Means/Limits Screen.

Procedure: Range Entry


1. Select a file from the RETIC QC SET UP screen by using the
arrow keys on the keyboard to move the cursor to the desired
file.
2. Press the [RETIC QC LIMITS] key followed by the [RANGE
ENTRY] key to display the RETIC QC RANGE ENTRY screen for
the selected file.
3. Use the arrow keys on the keyboard to move the cursor to the
desired entry field.
4. Type the desired numbers and press the Enter key on the
keyboard to save each entry.
5. If desired, press the [PRINT] key to obtain a printout of the
entered values.
6. Press the [RETURN] key to save the entries and return to the
RETIC QC SET UP screen.
NOTE: When entries are saved, the software checks to see if
any entries would result in the upper limit being less than the
lower limit. If this situation occurs, the limits are
automatically reversed. The bulletin line displays the
following message:

LIMITS WERE EXCHANGED TO MAKE UPPER > LOWER

Procedure: Means/Limits Entry


1. Select a file from the RETIC QC SET UP screen by using the
arrow keys on the keyboard to move the cursor to the desired
file.
2. Press the [RETIC QC LIMITS] key to display the RETIC QC MEANS/
LIMITS entry screen for the selected file.
3. Use the arrow keys on the keyboard to move the cursor to the
desired entry field.
4. Type the desired means and limits values and press the Enter
key on the keyboard to save each entry.

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Retic Menu Options Chapter 14

5. If desired, press the [PRINT] key to obtain a printout of the


entered values.
6. Press the [RETURN] key to save the entries and return to the
RETIC QC SET UP screen.

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Retic Set Up QC Soft Key

RETIC
The [TOGGLE ON/OFF] key is used to configure the QC file. The file
SET UP QC can be used for commercial controls. The lot number and
expiration date may be entered into the appropriate areas on the
RETIC SET UP QC screen (see the following figure) and saved by
pressing the Enter key on the keyboard. The following soft key
labels are displayed on the RETIC SET UP QC screen:

TOGGLE ON/OFF
PRINT
RETURN

TOGGLE
The Westgard Rule selections can be toggled ON or OFF using the
ON/OFF [TOGGLE ON/OFF] key.

The Westgard Rules are discussed in detail in Chapter 7: Quality


Control.

Mar 22 1998 14:10


RETIC SET UP QC Operator ID sy
Ready Retic Seq# R123
For File 1

Lot Number: _______


Expiration Date (Month/Day/Year): _ _/_ _/_ _

WESTGARD RULE SELECTION:

ON RULE 1: Value outside 3 SD.

OFF RULE 2: Two consecutive values outside SAME 2 SD.

ON RULE 3: Two consecutive values outside OPPOSITE 2 SD.

OFF RULE 4: Two of three consecutive values outside SAME 2 SD.

ON RULE 5: Four consecutive values outside SAME 1 SD.

OFF RULE 6: Ten consecutive values on SAME side of mean.

TOGGLE PRINT RETURN


ON/OFF

Figure 14.9: Retic Set Up QC Screen

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Procedure: QC File Set Up


1. Select a file from the RETIC QC SET UP screen by using the
arrow keys on the keyboard to move the cursor into the
desired file.
2. Press the [RETIC SET UP QC] key to display the RETIC SET UP QC
screen.
3. Move the cursor to the <Lot Number> entry field. Enter the
alphanumeric lot number with up to 9 characters. Press the
Enter key on the keyboard to save the entry.
4. The cursor will move to the <Expiration Date> entry field. Use
the same format indicated using one or two digits. Separate
the digits with a slash (/) or a period(.). Press the Enter key
on the keyboard to save the entry.
5. The cursor will advance to the <WESTGARD RULE SELECTION>
entry fields. Use the arrow keys on the keyboard to position
the cursor at the desired Westgard Rule. Press the [TOGGLE
ON/OFF] key to enable or disable the rule and advance the
cursor.
6. Repeat step 5 until all desired rule selections have been
made.
7. If desired, press the [PRINT] key to obtain a printout of the
entries.
8. Press the [RETURN] key to return to the RETIC QC SET UP
screen.
9. These steps can be repeated for each QC file you need to set
up.

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Operation Set Up Soft Key

Mar 22 1998 14:10


OPERATION SET UP MENU
Operator ID sy
Ready
Retic Seq# R123

TURN OFF BAR CODE COMPUTER RETURN


RETIC PKG SET UP SET UP

Figure 14.10: Operation Set Up Menu Screen with Reticulocyte Package


Enabled

OPERATION
The [OPERATION SET UP] key on the RETIC SET UP menu is used to
SET UP display the OPERATION SET UP MENU screen. The OPERATION SET UP
MENU screen in the Reticulocyte Package displays the following
soft keys:

TURN OFF RETIC PKG


BAR CODE SET UP
COMPUTER SET UP
RETURN

The [TURN OFF RETIC PKG] key is discussed earlier in this chapter
(in Retic Menu Options, Turning the Reticulocyte Package ON
and OFF). The [BAR CODE SET UP] and [COMPUTER SET UP] keys are
described in Chapter 5: Operating Instructions.

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Retic Units Selection Soft Key

Mar 22 1998 14:10


RETIC UNITS SELECTION
Operator ID sy
Ready
Retic Seq# R123

Parameters USA SI SI MOD SET 1 SET 2

RETIC % % % % % %
RETIC ABS K/uL G/L 10e9/L 10e3/uL 10e4/uL
RBC M/uL T/L 10e12/L 10e6/uL 10e4/uL

USA SI SI MOD SET 1 SET 2 SELECT RETURN


UNITS UNITS UNITS UNITS UNITS UNITS

Figure 14.11: Reticulocyte Units Selection Screen

RETIC
The [RETIC UNITS] key on the the RETIC SET UP screen is used to
UNITS display the RETIC UNITS SELECTION screen (see the preceding
figure). The RETIC UNITS SELECTION screen shows the report units
for the indicated parameters. Units may be selected for each
parameter individually, or a set of units may be selected by
pressing the appropriate soft key. The following soft key labels are
displayed on the RETIC UNITS SELECTION screen:

USA UNITS
SI UNITS
SI MOD UNITS
SET 1 UNITS
SET 2 UNITS
SELECT UNITS
RETURN

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Procedure: Retic Units Selection


1. From the RETIC SET UP menu, press the [RETIC UNITS] key.
2. Choose one of the following two options:
• To select a predefined set of units, press the appropriate
soft key. The group of selected units is highlighted on the
screen. If using this option, skip to step 6.
• For individual unit selection, use the arrow keys on the
keyboard to move the cursor to the desired units.
3. Press the [SELECT UNITS] key to enter the selection. The
chosen selection is highlighted on the display.
4. Use the arrow keys on the keyboard to move the cursor to the
next unit to be selected.
5. Repeat steps 3 and 4 until all selections have been made.
6. If desired, press the Print Screen key on the keyboard to
obtain a printout of the selected units.
7. Press the [RETURN] key to return to the RETIC SET UP menu.

Retic Run Menu


For a description of the RETIC RUN menu and the submenus that
are accessed from it, refer to Routine Operation, Retic Run Menu
within this chapter.

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Retic Data Log Menu

RETIC MAIN
Ready

RETIC DATA LOG


Ready

EDIT FIND TRANSMIT PRINT RETIC


DISPLAY SPECIMEN MAIN
ID SPECIMEN DATA DATA LOG

RETIC DATA LOG SEARCH


Ready

PREVIOUS NEXT EDIT TRANSMIT PRINT RETURN


SPECIMEN SPECIMEN SPECIMEN SPECIMEN REPORT

RETIC
The [RETIC DATA LOG] key on the RETIC MAIN menu screen is used
DATA LOG to display the RETIC DATA LOG screen. The Reticulocyte Data Log
stores all data (Reticulocyte percentage, RBC value, Reticulocyte
Absolute Number, IRF, and Reticulocyte Flags) and all patient
demographic information in a log format for each of the most
current 2,000 Reticulocyte cycles run on the CELL-DYN 3700
System. The record information is stored chronologically by
Reticulocyte Sequence Number. Each Reticulocyte Sequence
Number will have an "R" prefix (R0 to R1999). This will
distinguish the Reticulocyte Sequence Numbers from the
Standard Hematology Data Log sequence numbers. Scatterplots
and histograms are stored for all 2,000 records. The RBC value
will be identified on the RETIC DISPLAY SPECIMEN screen to show
whether it was obtained from the Standard Hematology Data Log
or entered by the operator. This section discusses the RETIC DATA
LOG screen first, then it discusses how to review data from the
Reticulocyte Data Log.

The current date, time, and operator ID and the last Reticulocyte
Sequence Number that was used are displayed in the upper right-
hand corner of the RETIC DATA LOG screen.

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RETIC DATA LOG Mar 22 1998 14:10


Operator ID 123
Ready
Retic Seq# R300

Seq Specimen ID RTC% RABS RBC IRF COUNT Date Time Op


R284 123456 0.68 34 5.01 0.21 O 09/29/00 08:10 987
R285 234567 4.40 176 4.00 0.59 O 09/29/00 08:30 964
R286 345678 2.10 74 3.50 0.36 O 10/02/00 09:05 657
R287 456789 1.76 48 2.69 0.10 O 10/02/00 09:27 864
R288 567890 13.40 418 3.12 0.68 O 10/03/00 08:38 987
R289 678901 0.96 40 4.15 0.17 O 10/03/00 09:07 964

Seq Specimen ID RTC% RABS RBC IRF COUNT Date Time Op

EDIT DISPLAY FIND TRANSMIT PRINT RETIC


ID SPECIMEN SPECIMEN DATA DATA LOG MAIN

Figure 14.12: Reticulocyte Data Log Screen

NOTE: Press the F12 key followed by the F1 key on the


keyboard to toggle between this Retic Data Log screen and
the Data Log screen.

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Retic Data Log Codes


The following letters are displayed on the RETIC DATA LOG screen
in the column immediately preceding the date. (See the preceding
figure.)
O Sample was run in the Open Mode.
K Flow Error or Fragile RBCs.
NOTE: Reticulocyte results are not suppressed for Fragile
RBCs but are suppressed for Flow Errors.

The RETIC DATA LOG screen contains the following soft keys:

EDIT ID (This key label is displayed only when the


cursor is positioned next to a patient
record.)
DISPLAY SPECIMEN
FIND SPECIMEN
TRANSMIT DATA
PRINT DATA LOG
RETIC MAIN

Edit ID Soft Key

EDIT
The [EDIT ID] key on the RETIC DATA LOG screen is used to edit only
ID the Specimen ID. When the [EDIT ID] key is pressed, the cursor
moves into the <SPECIMEN ID> field and all soft key labels are
blank. Each edit is saved by pressing the Enter key on the
keyboard.
NOTE: The [EDIT ID] key is displayed only when the cursor is
positioned next to a Reticulocyte Patient Record. It is not
displayed for Reticulocyte Background or Reticulocyte QC
records.
When using the Edit Specimen ID feature in the Data Log, set up a
laboratory procedure to verify any Specimen ID that has been
manually edited in the Data Log by showing the content of the
Specimen ID before and after editing.
Such verification could be:
Printouts of the Data Log summary reports that show the edited
ID. These printouts should be signed, dated and saved to ensure
tracking of any changes to specimen identification within your
laboratory.
OR
Re-running any specimen unintentionally identified with a Rack
and Tube Number, via Open or Closed Mode, to confirm that the
correct Specimen ID is applied.

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The current date, time, and operator ID and the last Reticulocyte
Sequence Number that was used are displayed in the upper right-
hand corner.

Display Specimen Soft Key

May 04 1998 13:50


Spec ID AA12345 RETIC DISPLAY SPECIMEN
Operator ID SH
Patient: Ready
Sequence # 1125
Sex(M/F): DOB
Dr.
LIMITS: 1

RETIC% 0.91 %
RBC 4.00 M/uL
RETIC ABS 36.00K/uL
IRF 0.10

RBC value entered by


Operator ID: SH

PREVIOUS EDIT TRANSMIT COLOR RETURN


SPECIMEN SPECIMEN SPECIMEN PRINT

Figure 14.13: Reticulocyte Display Specimen Screen

DISPLAY
The [DISPLAY SPECIMEN] key is used to display the results for the
SPECIMEN record indicated by the cursor position. The following soft keys
are displayed on the RETIC DISPLAY SPECIMEN screen:

PREVIOUS SPECIMEN (This key label is not displayed when


the first specimen in the RETIC DATA
LOG is on the screen.)
NEXT SPECIMEN (This key label is not displayed when
the last specimen in the RETIC DATA
LOG is on the screen.)
EDIT SPECIMEN
TRANSMIT SPECIMEN
PRINT REPORT or
COLOR PRINT (This key alternates between these
two selections depending on
whether the Color print option is
turned ON.)
RETURN

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Previous Specimen Soft Key

PREVIOUS
The [PREVIOUS SPECIMEN] key is used to display the results for the
SPECIMEN Reticulocyte Sequence Number preceding the one currently
displayed without returning to the main RETIC DATA LOG screen.

Next Specimen Soft Key

NEXT
The [NEXT SPECIMEN] key is used to display the results for the
SPECIMEN Reticulocyte Sequence Number following the one currently
displayed without returning to the RETIC DATA LOG screen.

Edit Specimen Soft Key

EDIT
The [EDIT SPECIMEN] key is used to edit patient demographic
SPECIMEN information for the selected record. It may also be used to edit and
display the results with a Parameter Set or Patient Limit Set
different from the one currently displayed. The following soft key
labels are displayed when the [EDIT SPECIMEN] key is pressed:
CONFIRM
CANCEL
These keys are used to [CONFIRM] or [CANCEL] the edits. The
bulletin line displays the message PRESS CONFIRM TO SAVE
CHANGES OR CANCEL TO CANCEL CHANGES. When the
[CONFIRM] key is pressed, the edited record is displayed.

Transmit Specimen Soft Key

TRANSMIT
The [TRANSMIT SPECIMEN] key is used to transmit the displayed
SPECIMEN report to a Laboratory Information System or on-line computer.

Print Report/Color Print Soft Key

PRINT
The [PRINT REPORT] key is used to print a graphics report for the
REPORT displayed report.
COLOR
PRINT
NOTE: The ticket printer is not supported in the
Reticulocyte mode.

The [COLOR PRINT] key will be displayed if the Color Print option is
turned on in the Standard Hematology Mode.

Return Soft Key

RETURN
The [RETURN] key is used to return to the RETIC DATA LOG screen.

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Find Specimen Soft Key

RETIC DATA LOG SEARCH Mar 22 1998 14:10


Seq # : R Operator ID jmb
Ready
Spec ID : Retic Seq# R326
Name :

Seq Specimen ID RTC% RABS RBC IRF COUNT Date Time Op


R284 123456 0.68 34 5.01 0.21 O 09/29/00 08:10 987
R285 234567 4.40 176 4.00 0.59 O 09/29/00 08:30 964
R286 345678 2.10 74 3.50 0.36 O 10/02/00 09:05 657
R287 456789 1.76 48 2.69 0.10 O 10/02/00 09:27 864
R288 567890 13.40 418 3.12 0.68 O 10/03/00 08:38 987
R289 678901 0.96 40 4.15 0.17 O 10/03/00 09:07 964

Seq Specimen ID RTC% RABS RBC IRF COUNT Date Time Op

Figure 14.14: Reticulocyte Data Log Search Screen

FIND
The [FIND SPECIMEN] key is used to locate a particular record by
SPECIMEN entering the Reticulocyte Sequence Number, the Reticulocyte
Specimen ID, or the patient’s name for the desired record. When
the [FIND SPECIMEN] key is pressed, the RETIC DATA LOG SEARCH
screen is displayed. (See the preceding figure.) The Reticulocyte
Specimen ID, the Reticulocyte Sequence Number, or the patient’s
name may be entered in the appropriate area. The cursor will be
flashing in the Reticulocyte Specimen ID area, but it can be
moved to the other areas by using the arrow keys on the keyboard.
If the requested reticulocyte record is available, the page of the
RETIC DATA LOG that contains that record will be displayed on the
screen. The cursor will be flashing next to the Reticulocyte
Sequence Number that was requested. The reticulocyte record can
be displayed by pressing the [DISPLAY SPECIMEN] key. If the record
is not found in the Reticulocyte Data Log, the bulletin line
displays the message NO ENTRY FOUND.

NOTE: If the patient name is used, the name must be typed


exactly as it was originally entered.

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Transmit Data Soft Key

TRANSMIT
When the [TRANSMIT DATA] key is pressed, the screen prompts the
DATA operator to enter the starting and ending Reticulocyte Sequence
Numbers (from the lowest to the highest) for the desired
transmission. Records may be transmitted to a Laboratory
Information System or on-line computer singly or in batches as
designated by the Reticulocyte Sequence Number(s).

Print Data Log Soft Key

PRINT
The [PRINT DATA LOG] key is used to print the Reticulocyte Data
DATA LOG Log. When the [PRINT DATA LOG] key is pressed, the screen prompts
the operator to enter the starting and ending Reticulocyte
Sequence Numbers (from the lowest to the highest) for the
desired printout. (See the following figure.)

Mar 22 1998 20:44


Starting Sequence # : R _ _ _ _ _ RETIC DATA LOG
Operator ID 883
Ready Retic Seq# R23

Seq Specimen ID RTC% RABS RBC IRF COUNT Date Time Op


R16 123456 0.68 34 5.01 0.21 O 09/29/00 08:10 987
R17 234567 4.40 176 4.00 0.59 O 09/29/00 08:30 964
R18 345678 2.10 74 3.50 0.36 O 10/02/00 09:05 657
R19 456789 1.76 48 2.69 0.10 O 10/02/00 09:27 864
R20 567890 13.40 418 3.12 0.68 O 10/03/00 08:38 987
R21 678901 0.96 40 4.15 0.17 O 10/03/00 09:07 964

Seq Specimen ID RTC% RABS RBC IRF COUNT Date Time Op

Figure 14.15: Reticulocyte Data Log Screen Showing the Starting Reticulocyte
Sequence Number Field

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Data Review from the Retic Data Log


Scrolling Through the Retic Data Log
The Page Up and Page Down keys on the keyboard can be used to
scroll rapidly through the records stored in the Reticulocyte Data
Log. Press the Page Up key to scroll backward and press the Page
Down key to scroll forward.

Displaying a Record
A copy of the RETIC RUN RESULT screen can be displayed for the
most current 2,000 records in the Reticulocyte Data Log. A record
is displayed by positioning the cursor at the record you desire in
the Reticulocyte Data Log listing and pressing the [DISPLAY
SPECIMEN] key. The Status Box indicates RETIC DISPLAY SPECIMEN
on results displayed (or printed) from the Reticulocyte Data Log
record. (See following figure.)

May 04 1998 13:50


Spec ID AA12345 RETIC DISPLAY SPECIMEN
Operator ID SH
Patient: Ready
Sequence # 1125
Sex(M/F): DOB
Dr.
LIMITS: 1

RETIC% 0.91 %
RBC 4.00 M/uL
RETIC ABS 36 K/uL
IRF 0.09

RBC value entered by


Operator ID: SH

PREVIOUS EDIT TRANSMIT COLOR RETURN


SPECIMEN SPECIMEN SPECIMEN PRINT

Figure 14.16: Reticulocyte Display Specimen Screen

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Procedure: Displaying a Record


1. From the RETIC MAIN menu screen press the [RETIC DATA LOG]
key.
2. If the desired record is not displayed on the screen, press the
[FIND SPECIMEN] key to display the RETIC DATA LOG SEARCH
screen.
3. To start the search, type the Reticulocyte Specimen ID, the
Reticulocyte Sequence Number, or the patient name, then
press the Enter key on the keyboard.
NOTE: If the patient name is used, the name must be typed
exactly as it was originally entered.

NOTE: If necessary, you may press the Escape key (ESC) or


the Enter key on the keyboard to exit from the search
function and return to the RETIC DATA LOG screen.

4. If the requested record is available, the screen displays the


page of the Reticulocyte Data Log with the cursor flashing at
the Reticulocyte Sequence Number of the record.
5. Press the [DISPLAY SPECIMEN] key to display the RETIC
DISPLAY SPECIMEN screen for the selected record.
6. Press the [PRINT REPORT] key (or the [COLOR PRINT] key if it is
displayed) to obtain a printout.
7. The [PREVIOUS SPECIMEN] or [NEXT SPECIMEN] key may now
be used to display records listed in the Reticulocyte Data Log
that are next to the one currently displayed.

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Retic QC Log Menu

RETIC MAIN
Ready

RETIC QC LOG
Ready

VIEW RETIC RETIC RETIC


QC LOG QC LIMITS SET UP QC MAIN

PURGE LEVEY- REJECT DELETE MOVE PRINT RETURN


QC LOGS JENNINGS SPECIMEN SPECIMEN SPECIMEN QC LOG
ACCEPT
SPECIMEN

PRINT RETURN

Mar 22 1998 14:54


RETIC QC LOG lym
Operator ID
Ready
Retic Seq# R4

File Name # Specimens

1. FILE 1 0
2. FILE 2 0
3. FILE 3 0
4. FILE 4 0
5. FILE 5 0
6. FILE 6 0

Press arrow key to select RETIC QC FILE at cursor position.

VIEW RETIC RETIC RETIC


QC LOG QC LIMITS SET UP QC MAIN

Figure 14.17: Reticulocyte QC Log Screen

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The [RETIC QC LOG] key on the RETIC MAIN menu screen is used to
RETIC
QC LOG display the RETIC QC LOG screen. The Reticulocyte Package on the
CELL-DYN 3700 System offers six QC Logs with statistical and
graphical analysis of the data. The statistical analysis includes the
mean, standard deviation, and coefficient of variation. The results
in each QC Log can be displayed as a Levey-Jennings chart.
Westgard Rules can be applied to each QC Log. The rule options
can be used independently or in combination, at the operator’s
discretion.
NOTE: The [RETIC QC LIMITS] key and the [RETIC SET UP QC]
key are used to set up the QC files.

The following soft keys are displayed on the RETIC QC LOG screen:
VIEW QC LOG (Move the cursor with the arrow keys
on the keyboard to the QC file
desired, then press this soft key.)
RETIC QC LIMITS
RETIC SET UP QC
RETIC MAIN

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View QC Log Soft Key

VIEW RETIC QC LOG Oct 11 2000 08:01


Lot Number : 0123ABCD4
Operator ID 902
Exp. Date: 09/24/00 Ready
LEVEL I: 2/120 Retic Seq# R44
Page 1 of 1

Upper Limits: 2.24 0.77


Lower Limits: 0.64 0.47
Target Mean: 1.44 0.62
Seq RTC% IRF DATE TIME Op
R31 1.38 0.60 O09/21/0013:45 902
R32 1.42 0.61 O09/21/0013:48 902

RTC% IRF
N: 2 2
FILE MEAN 1.40 0.61
Std Dev: 0.03 0.01
CV% 2.1 1.1

Auto-Sampler Pause

PURGE LEVEY- REJECT DELETE MOVE PRINT RETURN


QC LOG JENNINGS SPECIMEN SPECIMEN SPECIMEN QC LOG

Figure 14.18: View Reticulocyte QC Log Screen

VIEW
The [VIEW QC LOG] key is used to display the QC Log indicated by the
QC LOG position of the cursor. Each QC Log display includes the following
information (see the preceding figure):
1. The lot number and expiration date are displayed in the upper
left corner. The file name, the number of runs currently in
the file, and the file capacity are also in the upper left corner.
(For example, 35/120 indicates that the file contains 35 runs
out of a possible 120.) The page number of the display and
the total number of pages in the file are also displayed in the
upper left corner.
2. The current date, time, and operator ID and the last
Reticulocyte Sequence Number to be used are all displayed
in the upper right-hand corner.
3. The remainder of the screen displays the file information and the
data. The Upper and Lower Limits and Target Mean entered are
displayed immediately above each parameter name. The
Reticulocyte Sequence Number for each result is displayed to
the left of the data. The date, time, and operator ID when the
reticulocyte sample was run are displayed to the right of the data.

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4. The following QC Log codes are displayed in the column


immediately preceding the date. These codes are the same as
those used in the Reticulocyte Data Log.
O Sample was run in the Open Mode.
K Flow Error or Fragile RBCs.
NOTE: Reticulocyte results are not suppressed for Fragile
RBCs but are suppressed for Flow Errors.

5. The statistics are displayed below the data as follows:


N: The number of runs used in the
calculation.
FILE MEAN:The mean value for the number of runs
used in the calculation.
Std Dev: The standard deviation for the number of
runs used in the calculation.
CV%: The coefficient of variation, in percent,
for the number of runs used in the
calculation.
The following soft keys are displayed on the VIEW RETIC QC LOG
screen:
PURGE QC LOG
LEVEY-JENNINGS
REJECT SPECIMEN or
ACCEPT SPECIMEN (This key label alternates between these
two selections when the soft key is
pressed.)
DELETE SPECIMEN
MOVE SPECIMEN
PRINT QC LOG
RETURN

These soft keys are discussed in the order in which they appear on
the screen from left to right.

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Purge QC Log Soft Key

PURGE
The [PURGE QC LOG] key is used to delete the contents of a
QC LOG designated file in the QC Log. When the [PURGE QC LOG] key is
pressed, the following soft key labels are displayed:

CONFIRM PURGE
CANCEL PURGE

These soft keys are used to confirm or cancel the [PURGE QC LOG]
command. When the [CONFIRM PURGE] key is pressed, all the
results are deleted from the designated file (the data are no longer
displayed nor stored in the file). When the [CANCEL PURGE] key is
pressed, the results are not deleted.

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Levey-Jennings Soft Key

Mar 22 1998 16:58


QC file: RETIC FILE 1 RETIC LEVEY-JENNINGS jmb
Operator ID
Seq num: R328 to R339 Ready
Retic Seq# R341

WESTGARD RULE WARNINGS

RETIC %: - - - - - - IRF: - - - - - -

1.35 0.77

.850 0.62

.350 0.47

PREVIOUS NEXT PRINT RETURN


10 10

Figure 14.19: The Reticulocyte Levey-Jennings Screen

LEVEY-
The [LEVEY-JENNINGS] key is used to display the Levey-Jennings
JENNINGS graphs of the data in the QC Log. (See the preceding figure.) Up to
30 data points can be displayed on the screen at one time. If there
are more than 30 data points in the QC Log, the [PREVIOUS 10] and
[NEXT 10] keys can be used to scroll through the graphs. The
following soft key labels are displayed when the [LEVEY-JENNINGS]
key is pressed:
PREVIOUS 10 (This key is not displayed when the first
10 data points are displayed.)
NEXT 10 (This key is not displayed when the last
10 data points are displayed.)
PRINT
RETURN

PRINT The [PRINT] key is used to print the Levey-Jennings graphs.

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The [RETURN] key is used to return to the VIEW RETIC QC LOG


RETURN screen.

VIEW RETIC QC LOG Oct 11 2000 08:01


Lot Number : 0123ABCD4
Operator ID 902
Exp. Date: 09/24/00 Ready
LEVEL I: 2/120 Retic Seq# R44
Page 1 of 1

Upper Limits: 2.24 0.77


Lower Limits: 0.64 0.47
Target Mean: 1.44 0.62
Seq RTC% IRF DATE TIME Op
R31 1.38 0.60 O 09/21/00 13:45 902
R32 1.42 0.61 O 09/21/00 13:48 902

RTC IRF
N: 2 2
FILE MEAN 1.40 0.61
Std Dev: 0.03 0.01
CV%: 2.1 1.1

Auto-Sampler Pause

PURGE LEVEY- REJECT DELETE MOVE PRINT RETURN


QC LOG JENNINGS SPECIMEN SPECIMEN SPECIMEN QC LOG

Figure 14.20: View Reticulocyte QC Log Screen with Rejected Results

Reject Specimen/Accept Specimen Soft Key

REJECT
The [REJECT SPECIMEN] key is used to exclude the results for the
SPECIMEN specimen indicated by the cursor position. When the soft key is
ACCEPT pressed, the key label changes to [ACCEPT SPECIMEN], an “R” is
SPECIMEN
displayed in the column immediately left of the results, and the
statistics are recalculated excluding those results. (See the
preceding figure.) The data are still displayed and stored in the
file, but they are excluded from the statistical calculations.
When the [ACCEPT SPECIMEN] key is pressed, the “R” is deleted and
the statistics are recalculated including those results.

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Delete Specimen Soft Key

DELETE
The [DELETE SPECIMEN] key is used to delete the results for the
SPECIMEN specimen indicated by the cursor position. When the [DELETE
SPECIMEN] key is pressed, the following soft key labels are
displayed:
CONFIRM DELETION
CANCEL DELETION
These soft keys are used to confirm or cancel the Delete Specimen
command. When the [CONFIRM DELETION] key is pressed, the
results are deleted from the file (the data are no longer displayed
nor stored in the file) and the statistics are recalculated excluding
those results.

Move Specimen Soft Key

MOVE
The [MOVE SPECIMEN] key is used to move the QC result indicated
SPECIMEN by the cursor position to another QC file. When the [MOVE
SPECIMEN] key is pressed, the RETIC QC LOG screen is displayed,
allowing the desired file to be selected. When the [MOVE TO FILE]
key is pressed, the result is moved to the indicated file.

Procedure: Move Specimen Soft Key


1. From the RETIC QC LOG screen, use the arrow keys on the
keyboard to move the cursor to the file containing the result
to be moved.
2. Press the [VIEW QC LOG] key.
3. Use the arrow keys on the keyboard to position the cursor at
the result that is to be moved.
4. Press the [MOVE SPECIMEN] key to again display the RETIC QC
LOG menu.
5. Use the arrow keys on the keyboard to move the cursor to the
file in which the results are to be placed.
6. Press the [MOVE TO FILE] key to move the results to the
designated file.
NOTE: The results are moved to the end of the list of data
that is currently in the file.

7. The VIEW RETIC QC LOG screen for the original file is


displayed showing that results have been moved.

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Print QC Log Soft Key


PRINT
QC LOG
The [PRINT QC LOG] key is used to print the entire QC Log.

RETURN
Return Soft Key
The [RETURN] key is used to return to the RETIC QC LOG screen.

Retic Diagnostics Menu

RETIC MAIN
Ready

RETIC DIAGNOSTICS
Ready

FAULT RETIC CNT CLEAR RAW DATA INITIAL- RETIC


REPORT RATE SUMM FAULT SUMMARY IZATION MAIN

RETIC PRINT RETURN PRINT RETURN


CNT GRAPH
RETIC
CNT RATE

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RETIC DIAGNOSTICS Mar 22 1998 14:10


Operator ID lym
Ready
Retic Seq# R4

FAULT RETIC CNT CLEAR RAW DATA INITIAL- RETIC


REPORT RATE SUMM FAULT SUMMARY IZATION MAIN

Figure 14.21: Reticulocyte Diagnostics Screen

The [RETIC DIAGNOSTC] key is used to display the RETIC


RETIC
DIAGNOSTC DIAGNOSTICS screen. The soft keys displayed on this screen enable
the operator or service representative to obtain information and
execute programs that assist in troubleshooting and in identifying
the corrective action needed. The RETIC DIAGNOSTICS screen
displays a subset of the soft keys displayed on the main
DIAGNOSTICS menu. The following soft keys are displayed on the
RETIC DIAGNOSTICS screen:

FAULT REPORT
RETIC CNT RATE SUMM
CLEAR FAULT
RAW DATA SUMMARY
INITIALIZATION
RETIC MAIN

These soft keys are discussed in the order in which they appear on
the screen from left to right.

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Fault Report Soft Key


When the [FAULT REPORT] key is pressed, information regarding
FAULT
REPORT any pending fault is displayed on the screen. The screen displays
the words OPERATOR CORRECTABLE FAULT REPORT: or
FATAL FAULT REPORT and any additional information available.
If there is no fault, the screen displays the words NO FAULT
PENDING. Operator-correctable faults (for example, Waste Full,
Diluent Empty) can be cleared after the corrective action has been
taken by pressing the [CLEAR FAULT] key. After corrective action
has been taken for a Fatal Fault, the system must be reinitialized.

Retic Count Rate Summary Soft Key

Mar 22 1998 17:30


RETIC COUNT RATE SUMMARY jmb
Operator ID
Ready
Retic Seq# R291

WOC: TOTAL COUNT: 72861


TIME: 0.53 1.06 1.59 2.11 2.65 3.18 3.71 4.24
COUNT: 4672 9567 14692 19755 25078 30225 35779 40902
RATE: 8899.05 9235.85 9669.81 9643.81 9949.53 9620.56 10479.24 9666.04
TIME: 4.77 5.30 5.80 6.33 6.85 7.35 7.50
COUNT: 46231 51353 56354 61591 66695 71487 72861
RATE: 10054.71 9756.20 9902.97 9975.24 9721.90 9584.00 9159.99

RETIC PRINT RETURN


CNT GRAPH

Figure 14.22: Reticulocyte Count Rate Summary Screen (Tabular Format)

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When the [RETIC CNT RATE SUMM] key is pressed, the following soft
RETIC CNT
RATE SUMM key labels are displayed:

RETIC CNT GRAPH


PRINT
RETURN

The data displayed on the screen are the kinetic data for the
Reticulocyte specimen from the last run, displayed in a tabular
format. (See the preceding figure.) The total count, data
acquisition intervals, and rate per second are displayed.
When the [RETIC CNT GRAPH] key is pressed, the rate per second
RETIC CNT
GRAPH data are displayed as a graph. (See the following figure.) The
RETIC kinetic data and graph information are useful when
CNT RATE troubleshooting problems with the reticulocyte parameter. A
printout of the Reticulocyte Count Rate Summary may be
obtained by pressing the [PRINT] key when the desired format is
displayed on the screen.

RETIC COUNT RATE SUMMARY Mar 22 1998 17:30


Ready Operator ID jmb
Retic Seq# R291

10479.2
9169.3
7859.4
6549.5
5239.6
3929.7
2691.8
1309.9

0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5
RETIC CNT GRAPH

RETIC PRINT RETURN


CNT RATE

Figure 14.23: Reticulocyte Count Rate Summary Screen (Graphic Format)

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Clear Fault Soft Key


When the [CLEAR FAULT] key is pressed, the Analyzer returns to
CLEAR
FAULT
the READY state if the corrective action that was taken has
resolved the problem. If the corrective action did not correct the
problem, the fault status does not change.

NOTE: Only operator-correctable faults can be cleared with


the [CLEAR FAULT] key.

Raw Data Summary Soft Key

Mar 22 1998 17:37


RETIC RAW DATA SUMMARY
Operator ID jmb
Ready
Retic Seq# R293

List Mode WOC: 30000


Raw Count WOC: 62039

PRINT RETURN

Figure 14.24: Reticulocyte Raw Data Summary Screen

When the [RAW DATA SUMMARY] key is pressed, information


RAW DATA
SUMMARY
pertaining to the last cycle run in the Reticulocyte Package is
displayed.

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Initialization Soft Key


When the [INITIALIZATION] key is pressed, the system is
INITIAL-
IZATION
reinitialized. The system exits the Reticulocyte Package and
returns to the Standard Hematology mode.

Print Soft Key


When the [PRINT] key is pressed, a Diagnostics Report is printed.
PRINT
This report contains information pertinent to the data displayed
on the screen at the time the key is pressed. If no data are
displayed on the screen, the printed report contains the current
fault status.

Retic Main Soft Key


The [RETIC MAIN] key is used to return to the RETIC MAIN menu
RETIC
MAIN
screen. The [RETIC MAIN] key appears on each primary RETIC
DIAGNOSTICS screen and works the same way on each screen.

Retic Special Protocols Menu

RETIC MAIN
Ready

RETIC SPECIAL PROTOCOLS


Ready

FLUSH EMPTY CLEAN DISABLE RETIC


SHEATH WOC SHEAR VLV ANALYZER MAIN
FILL RESTORE ENABLE
WOC SHEAR VLV ANALYZER

The [RETIC SP PROTOCOLS] key is used to display the RETIC SPECIAL


RETIC SP
PROTOCOLS
PROTOCOLS menu. The following soft key labels are displayed on
the RETIC SPECIAL PROTOCOLS menu:
FLUSH SHEATH
EMPTY WOC or
FILL WOC (This key label alternates
between these two selections.)

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CLEAN SHEAR VLV or


RESTORE SHEAR VLV (This key label alternates
between these two selections.)
DISABLE ANALYZER or
ENABLE ANALYZER (This key label alternates
between these two selections.)
RETIC MAIN

A brief description of the function of each soft key follows.


Instructions for the detailed use of each function are given
in the appropriate maintenance procedure in Chapter 9:
Maintenance.

Mar 22 1998 14:10


RETIC SPECIAL PROTOCOLS
Operator ID lyn
Ready
Retic Seq# R4

FLUSH EMPTY CLEAN DISABLE RETIC


SHEATH WOC SHEAR VLV ANALYZER MAIN

Figure 14.25: Reticulocyte Special Protocols Screen

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Flush Sheath Soft Key


FLUSH The [FLUSH SHEATH] key is used to flush the WOC Flow Cell with
SHEATH Sheath Reagent.

Empty WOC/Fill WOC Soft Key


EMPTY The [EMPTY WOC] key is used to drain the reagent from the WOC
WOC flow cell. When the flow cell is empty, the soft key label changes
FILL to [FILL WOC].
WOC

When the [FILL WOC] key is pressed, the flow cell is refilled with
reagent. When the flow cell is filled, the soft key label changes
back to [EMPTY WOC].

Clean Shear Valve/Restore Shear Valve Soft Key


CLEAN The [CLEAN SHEAR VLV] key is used to prepare the shear valve for
SHEAR VLV cleaning. When the soft key is pressed, the syringes will partially
RESTORE empty, which flushes the reagents out of the shear valve and the
SHEAR VLV
associated tubings. The shear valve then rotates into the position
necessary for its removal. When the rotation is complete, the soft
key label changes to [RESTORE SHEAR VLV].

When the [RESTORE SHEAR VLV] key is pressed, the syringes refill
the shear valve and the associated tubings and the shear valve
rotates back to its operational position. When the rotation is
complete, the soft key label changes back to [CLEAN SHEAR VLV].

Disable Analyzer/Enable Analyzer Soft Key


DISABLE The [DISABLE ANALYZER] key is used to prevent the Analyzer from
ANALYZER cycling while certain maintenance procedures are performed.
ENABLE When the Analyzer is disabled, the soft key label changes to
ANALYZER
[ENABLE ANALYZER].

When the [ENABLE ANALYZER] key is pressed, the Analyzer is


returned to the operational state and the soft key label changes
back to [DISABLE ANALYZER].

Retic Main Soft Key


RETIC The [RETIC MAIN] key is used to return to the RETIC MAIN menu
MAIN screen.

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Chapter 14 Routine Operation

Routine Operation

Overview
This section contains information and procedures that are
recommended for the routine operation of the Reticulocyte
Package for the CELL-DYN 3700 System. This section contains the
following subsections:
• Retic Run Menu Flowchart
• Retic Run Menu
• Reticulocyte Specimens
• Specimen Requirements
• Running Specimens
• Background
• Quality Control
• Patient
• Interfering Substances
• Specimen Preparation
For instructions on turning the Reticulocyte Package ON and OFF,
refer to Retic Menu Options, Turning Reticulocyte Package On
and OFF within this chapter.

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Retic Run Menu Flowchart

RETIC MAIN
Ready

RETIC RUN
Ready

PATIENT QC BACK- RETIC


SPECIMEN SPECIMEN GROUND MAIN

RETIC PATIENT SPECIMEN RETIC RUN RESULT RETIC RUN RESULT


Ready Ready Ready

ENTER DATA

RETIC RUN RESULT


Ready

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Retic Run Menu

Mar 22 1998 14:10


RETIC RUN lyn
Operator ID
Ready
Retic Seq# R4

File Name # Specimens

1. FILE 1 0
2. FILE 2 0
3. FILE 3 0
4. FILE 4 0
5. FILE 5 0
6. FILE 6 0

Press QC SPECIMEN softkey to select QC FILE at cursor position.

PATIENT QC BACK- RETIC


SPECIMEN SPECIMEN GROUND MAIN

Figure 14.26: Reticulocyte Run Screen

RETIC The [RETIC RUN] key on the RETIC MAIN menu screen is used to
RUN display the RETIC RUN screen. (See the preceding figure.) This
screen allows the operator to decide which type of Reticulocyte
specimen will be analyzed. The upper right-hand corner of the
screen contains the current time and date, the operator ID, and the
next Reticulocyte Sequence Number.
The following soft keys are displayed on the RETIC RUN screen:
CLEAR FAULT (This key label appears whenever a
system fault occurs.)
PATIENT SPECIMEN
QC SPECIMEN
BACKGROUND
RETIC MAIN
These soft keys will be discussed as they appear on the RETIC RUN
screen from left to right.

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Clear Fault Soft Key


CLEAR The [CLEAR FAULT] key is displayed on the RETIC RUN screen
FAULT whenever a system fault occurs (for example, Diluent Empty).
This key is used after corrective action has been taken, to clear the
fault message and return the Analyzer to the Ready state.
NOTE: A message describing the fault is displayed on the
bulletin line. A list of fault conditions and corrective action is
given in Chapter 10: Troubleshooting.

Patient Specimen Soft Key


PATIENT The [PATIENT SPECIMEN] key on the RETIC RUN screen is used to
SPECIMEN display the first RETIC PATIENT SPECIMEN screen. (See the following
figure.) The patient specimen ID (up to 12 alphanumeric
characters) is entered here. Type the information and press the
Enter key on the keyboard to confirm the entry. The Standard
Hematology Data Log will then be searched for the entered
specimen ID.
NOTE: If the patient name is used for the specimen ID, the
name must be typed exactly as it was originally entered in
the Standard Hematology Data Log.

NOTE: Specimen IDs must match exactly and are case


sensitive.

RETIC PATIENT SPECIMEN Mar 22 1998 15:02


Operator ID lyn
Ready
Retic Seq# R4

ENTER SPECIMEN ID: 123456 Press ENTER to confirm.

CANCEL

Figure 14.27: The First Reticulocyte Patient Specimen Screen

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If the specimen ID is found, the second RETIC PATIENT SPECIMEN
screen is displayed. (See the following figure.) This screen displays
the patient demographic information and the most recent RBC
value found in the Standard Hematology Data Log.
NOTE: To ensure optimal flagging, perform the CBC run
within 8 hours prior to the Retic run on the same analyzer
using the same specimen.

This screen also displays the following question:


Use demographics and RBC value?-(Y/N).

• If a Y is entered, the RETIC RUN RESULT screen will display the


patient demographic information and RBC value.
NOTE: If no RBC value is displayed (if there is a blank space
following RBC), the RBC value was suppressed due to an RBC
metering fault. Type "N" to display a manual RBC entry
screen.

• If an N is entered, the RETIC RUN RESULT screen will be


displayed without the patient demographic information or the
RBC value.
If an entry error is made in the second RETIC PATIENT SPECIMEN
screen, the operator may press the [CANCEL] key to return to the
first RETIC PATIENT SPECIMEN screen.

Mar 22 1998 15:02


RETIC PATIENT SPECIMEN lyn
Operator ID
Ready R4
Retic Seq#

PATIENT ID : C01804

PATIENT ID : C01804 found in HEMATOLOGY DATA LOG at Sequence # 592

Patient: _ _ _ _ _ _ _ _ _ _ _ _ _ _

Sex (M/F): _ _ DOB: 00/00/00

Dr. _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

RBC 5.48 M/uL

Use demographics and RBC value? - (Y/N)

CANCEL

Figure 14.28: The Second Reticulocyte Patient Specimen Screen (Displayed


When the Specimen ID is Found)

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If the ID located is from a specimen run more than 8 hours ago,


the third RETIC PATIENT SPECIMEN screen is displayed. (See the
following figure.)

RETIC PATIENT SPECIMEN Mar 22 1998 15:02


Operator ID lyn
Ready
Retic Seq# R4

ENTER SPECIMEN ID: 365127 Press ENTER to confirm.


SPECIMEN ID: 365127 was found in HEMATOLOGY DATA LOG
but specimen data are more than 8 hours old . . .

Enter RBC value - - - - - - - M/uL. Press ENTER to confirm.

CANCEL

Figure 14.29: The Third Reticulocyte Patient Specimen Screen (Displayed


When the Specimen ID Found is More Than Eight Hours Old)

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If the Specimen ID is not found in the Standard Hematology Data


Log, the fourth RETIC PATIENT SPECIMEN screen is displayed. (See
the following figure.) This screen displays a place for the operator
to enter the RBC value. If an entry error is made in the fourth
RETIC PATIENT SPECIMEN screen, the operator may press the
[CANCEL] key to return to the first RETIC PATIENT SPECIMEN screen.
If the operator presses the Enter key to confirm the RBC value, the
RETIC RUN RESULT screen is displayed.

Mar 22 1998 15:03


RETIC PATIENT SPECIMEN
Operator ID lyn
Ready
Retic Seq# R4

PATIENT ID : 123456

PATIENT ID : 123456 was NOT found in HEMATOLOGY DATA LOG

Enter RBC value - - - - - - M/uL. Press ENTER to confirm.

CANCEL

Figure 14.30: The Fourth Reticulocyte Patient Specimen Screen (Displayed


When the Specimen ID Is Not Found)

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Retic Run Result Screen

May 04 1998 11:44


1 Spec ID AA12345 RETIC RUN RESULT
Operator ID SH
2 Patient: Ready
ReticSeq# R4
3 Sex(M/F):- DOB:--/--/--
4 Dr.--------------------
5 Limits: 1

RETIC% 0.91 %
RBC 4.00 M/uL
RETIC ABS 36 K/uL
IRF 0.10

RBC value entered by:


Operator ID: SH

NEXT COLOR
RETIC PRINT

Figure 14.31: The Reticulocyte Run Result Screen for a Patient Specimen

Upper Left Corner


The numbers in the upper left-hand corner of the RETIC RUN
RESULT screen (shown in the preceding figure) correspond with
the following numbered data entry fields:
1. <Specimen ID> This data entry field automatically displays the
specimen ID (up to 12 characters), which
was previously entered on the RETIC PATIENT
SPECIMEN screen.
2. <Patient> This data entry field automatically displays
the patient’s name if it was found in the
Standard Hematology Data Log when the
patient specimen ID was entered into the
first RETIC PATIENT SPECIMEN screen. If the
information was not found in the Standard
Hematology Data Log, the patient name can be
entered here (up to 16 characters).
NOTE: If an entry error is made in the second RETIC PATIENT
SPECIMEN screen, the operator may press the [CANCEL] key to
return to the first RETIC PATIENT SPECIMEN screen.

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3. <Sex (M/F):/DOB> This data entry field automatically


displays the sex and birth date of the
patient if it was found in the Standard
Hematology Data Log. If the information
was not found in the Standard
Hematology Data Log, the sex and birth
date of the patient can be entered here.
4. <Dr.> This data entry field automatically
displays the name of the patient’s doctor
if it was found in the Standard
Hematology Data Log. If the information
was not found in the Standard
Hematology Data Log, the name of the
patient’s doctor can be entered here (up
to 22 characters).
5. <Limits> This data entry field automatically
displays the number of the Limit Set that
will be applied to the sample results.
NOTE: The Limit Set applied to the reticulocyte sample may
be changed after the specimen has been run. Refer to the
description for the [EDIT SPECIMEN] key given in Reticulocyte
Menu Options, Reticulocyte Data Log Menu, Display
Specimen Soft Key within this chapter.

These demographics can be entered or changed before the


Reticulocyte specimen is processed, or while the EDIT SPECIMEN
screen in the Reticulocyte Data Log is displayed.

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Top Center
The Status Box is displayed in the top center of the RETIC RUN
RESULT screen. This box appears on every screen to show the
following information:·
• The menu in use (such as RETIC RUN RESULT).
• The status of the Analyzer (such as Ready, Not ready,
and FAULT messages).
• Status and instructive messages. During the Reticulocyte
Run cycle these are:
Aspirating
Remove Specimen
Dispensing
Rinsing
Processing Data
Ready

Upper Right Corner


The upper right-hand corner of the RETIC RUN RESULT screen
displays the following information:
• The current date and time.
• The operator ID (which identifies the current operator).
• The Reticulocyte Sequence Number. ("R _ _ _ _ ," which
automatically increments as reticulocyte samples are run.)

Center
The center section of the RETIC RUN RESULT screen displays the
results. The list of the parameters and results is displayed on the
left side. The information on RBC value entry is also displayed on
the left side. The scatterplot and the histograms are displayed on
the right. The red blood cells are shown in red, the reticulocytes
are shown in blue, the nucleated cells are shown in white (black
on the color printout), the immature Reticulocytes are shown in
cyan (light blue), and coincidence passage events are shown in
green and the noise is shown in yellow. Any alert messages will
appear in the lower left-hand corner of the screen.

The following soft key labels are displayed on the RETIC RUN
RESULT screen:
NEXT RETIC (This soft key label appears when the
Reticulocyte specimen run has been
completed.)
PRINT REPORT
RETURN (This key is used to return to the RETIC
RUN screen.)

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QC Specimen Soft Key

IRF

Figure 14.32: Reticulocyte Run Result Screen for a QC Specimen

QC When the [QC SPECIMEN] key on the RETIC RUN screen is pressed, the
SPECIMEN QC file where the cursor is positioned is opened and the RETIC RUN
RESULT screen for QC specimens is displayed. (See the preceding
figure.) Results from the QC run option are stored in the selected
reticulocyte QC file and in the Reticulocyte Data Log.

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Background Soft Key

Figure 14.33: Reticulocyte Run Result Screen for a Background Specimen

BACK- When the [BACKGROUND] key on the RETIC RUN screen is pressed,
GROUND the RETIC RUN RESULT screen for background counts is displayed.
(See the preceding figure.) Results from this run option are
identified by the designation BACKGROUND on the RETIC RUN
RESULT screen and in the Retic Data Log.

Retic Main Soft Key


RETIC When the [RETIC MAIN] key is pressed, the RETIC MAIN menu screen
MAIN is displayed.

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Chapter 14 Routine Operation

Reticulocyte Specimens
Overview
This subsection discusses routine operation of the Reticulocyte
Package. Guidelines and procedures are provided for running
background counts, quality control, and patient specimens. The
Reticulocyte Package is only available for use in the Open Sampler
Mode.
For background counts, a tube of reticulocyte reagent is run
without an aliquot of whole blood, to check for particulate
material in the reagent and system.
Control material should be properly warmed and mixed according
to the manufacturer’s recommendations. Patient reticulocyte
controls should be handled according to the laboratory’s protocol.
Quality control checks (which verify Reticulocyte Package
performance) should be performed on each shift that reticulocyte
samples are run.
Each reticulocyte sample is run by starting from the RETIC RUN
screen. The operator selects the type of Reticulocyte specimen to
be run (Patient, QC, or Background) and proceeds through the
screen(s) displayed for that specimen type. When the reticulocyte
sample is completed, the [NEXT RETIC] key is displayed. When the
[NEXT RETIC] key is pressed, the operator can then select the
specimen type for the next specimen. Specific instructions for
each specimen type are given in this section of this chapter.
CAUTION: When using the reticulocyte reagent, avoid
contact with skin and clothing. This reagent contains New
Methylene Blue, which will stain skin, clothing, and many
other surfaces.

WARNING: Potential Biohazard. Consider all clinical


specimens and controls that contain human blood or
serum as potentially infectious. Use established,
good laboratory working practices when handling these
specimens. Wear appropriate personal protective
equipment and follow other biosafety practices as
specified in the OSHA Bloodborne Pathogen Rule or other
equivalent biosafety procedures.

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Specimen Requirements
• Do not run hemolyzed specimens, as they may result in
inaccurate reticulocyte values.
• Specimens may be run up to 8 hours after collection time
without refrigeration.
NOTE: Studies have shown that reticulocytes continue to
mature at room temperature. Increased flagging can occur
when using specimens more than 8 hours old.

• If a specimen is more than 8 hours old and the CBC was


processed on the CELL-DYN 3700 System more than 8 hours
ago, obtain the RBC value from the Standard Hematology Data
Log before entering the Reticulocyte Package. The Reticulocyte
Package will select RBC values only for specimens processed
within the last 8 hours.
• To ensure optimal flagging, perform the CBC run within 8
hours prior to the Retic run on the same analyzer using the
same specimen.
NOTE: Specimen IDs must match exactly and are case
sensitive.

• It is recommended that the RBC value used to determine the


reticulocyte absolute number be selected from the results for
the same specimen that will be used for the reticulocyte
count.

Interfering Substances
The CELL-DYN 3700 Reticulocyte method is a nucleic acid
staining method. Therefore, other substances that contain nucleic
acids could potentially be enumerated by the instrument as
reticulocytes. If these interfering substances are present in
sufficient numbers, they may interfere with the dynamic
thresholds used to obtain the CELL-DYN 3700 reticulocyte count.
Consequently, these specimens should be flagged by the
instrument. Refer to Troubleshooting, Instrument Alert
Conditions within this chapter for a complete description of the
Reticulocyte flags.
The information in the following table, based on CLSI/NCCLS
Document H44-A21 indicates substances that are known or
potential interferents. The CELL-DYN 3700 Reticulocyte
procedure is designed to minimize some common interferents,
including high WBC counts and NRBCs.

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Table 14.1: Potential Interfering Substances

Cellular Elements Cellular Inclusions Miscellaneous


Massive platelet Howell-Jolly bodies Abnormal red cells
clumps
Heinz bodies Paraproteins
Basophilic stippling
Pappenheimer bodies Cold agglutinins
Leukocyte fragments
Parasites (malaria, Platelet/erythrocyte
Nucleated babesia) coincidence
erythrocytes >200
NRBC/100 WBC Hemolysis

Running Specimens
This section contains information and procedures recommended
for routine operation of the Reticulocyte Package. Proper start-up
procedures should be performed prior to processing patient
specimens. These include the background counts and daily quality
control checks described in the following sections.

Background Counts
The reticulocyte background count must be included in the daily
start-up procedures to check for particulate matter in the
reticulocyte reagent and the CELL-DYN 3700 System. The
background count is determined from the total counts that occur
in the reticulocyte scatter area on the 10°/90° scatterplot.

Procedure: Background Count


1. Select a tube from the current lot of reticulocyte reagent that
will be used for the day's testing.
2. Label the tube "Retic Background" and record the current
date on the tube.
NOTE: One tube may be used to check daily background
counts for a one-week period, provided the reagent is not
contaminated.

3. Turn the Reticulocyte Package ON as directed in Retic Menu


Options, Turning the Reticulocyte Package ON and OFF
within this chapter.
4. From the RETIC MAIN menu screen, press the [RETIC RUN] key
followed by the [BACKGROUND] key.

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Routine Operation Chapter 14

5. Be sure that the word READY is illuminated on the Analyzer


Status Indicator Panel and the word Ready is displayed in
the Status Box on the RETIC RUN RESULT screen.
6. Open the tube labeled "Retic Background" and immerse the
Open Sample Aspiration Probe in the reagent.
7. Press the Touch Plate located behind the probe to start the
cycle. The word BUSY will be illuminated in yellow on the
Analyzer Status Indicator Panel. The Status Box on the RETIC
RUN RESULT screen will display messages indicating the
various stages of the cycle.
8. Remove the tube when the beep sounds. The Wash Block will
move down the probe and clean it.
9. When the cycle is complete, the Wash Block moves back to
the top of the probe and the Ready message is displayed in
the Status Box.
NOTE: No message is illuminated on the Analyzer Status
Indicator Panel until the [NEXT RETIC] key is pressed and the
operator has selected the specimen type for the next
specimen to be processed.

10. The screen displays the background count results as


Background Count Found in Retic Area.
11. Verify that the background count is within the acceptable
limit of less than 100 counts.
NOTE: Results that are outside the acceptable range are
displayed in purple.

12. If the background count is unacceptable, repeat it. If the


repeated count is still unacceptable, follow the directions for
troubleshooting background count problems given in the
Troubleshooting section of this chapter.

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Chapter 14 Routine Operation

Quality Control
Quality control checks should be performed daily according to
the laboratory’s protocol. Control material should be properly
warmed and prepared according to the manufacturer’s
recommendations. Patient controls should be handled according
to the laboratory’s protocol. For customizing the QC files, see
Chapter 5: Operating Instructions, Subsection: Set Up
Instructions, QC Set Up Menu.

Procedure: Quality Control


1. Warm the control material according to the manufacturer’s
recommendations.
2. Use reticulocyte reagent and verify the expiration date.
Store the stock reagent in the dark at room temperature.
3. Label one tube of reticulocyte reagent for each level of
control material.
4. Pipette 20 µL of the control material into each labeled tube
of reticulocyte reagent.
5. Incubate the prepared control specimens on the rotator or in
a rack, after fully inverting the stained specimens 5 times.
Incubation is performed according to the Reagent Package
Insert.
6. Verify that the Reticulocyte Package is turned ON. For
instructions on turning ON the Reticulocyte Package, refer
to Retic Menu Options, Turning the Reticulocyte Package
ON and OFF within this chapter.
7. From the RETIC MAIN menu screen press the [RETIC RUN] key.
8. From the RETIC RUN screen, move the cursor to the desired
QC file and press the [QC SPECIMEN] key. The RETIC RUN
RESULT screen for QC specimens is displayed. The control file
information is located in the upper left-hand corner of the
screen.
9. Open the well-mixed, prepared control specimen tube and
immerse the Open Sample Aspiration Probe in the sample.
10. Press the Touch Plate located behind the probe to start the
cycle. The word BUSY on the Analyzer Status Indicator Panel
will be illuminated in yellow. The Status Box on the RETIC
RUN RESULT screen will display messages to indicate the
various stages of the cycle.
11. Remove the tube when the beep sounds. The Wash Block
moves down the probe and cleans it.

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12. When the cycle is completed, the Wash Block moves up the
probe.
NOTE: The word Ready appears in the Status Box. No
message is illuminated on the Analyzer Status Indicator Panel
until the [NEXT RETIC] key is pressed on the RETIC RUN
RESULT screen and the operator has selected the specimen
type for the next specimen to be processed from the RETIC
RUN screen.
13. Repeat steps 8 through 12 for all prepared control specimens.
14. Verify that the control results are acceptable.
NOTE: Out-of-range results are displayed in color. Data
invalidating alerts, such as Fragile RBCs, are not valid when
running commercial controls.
15. If the results are unacceptable, repeat the run. If the results
are still unacceptable, run the other levels of the control
material. If the results are still unacceptable, prepare another
stained dilution of that level of the control material. If the
results on all levels are unacceptable, troubleshoot
accordingly. See Chapter 10: Troubleshooting.
16. When the control results are acceptable, patient samples may
be analyzed.

Patient Specimens
CAUTION: When using the reticulocyte reagent, avoid
contact with skin and clothing. This reagent contains New
Methylene Blue, which will stain skin, clothing, and many
other surfaces.

WARNING: Potential Biohazard. Consider all clinical


specimens and controls that contain human blood or
serum as potentially infectious. Use established,
good laboratory working practices when handling these
specimens. Wear appropriate personal protective
equipment and follow other biosafety practices as
specified in the OSHA Bloodborne Pathogen Rule or other
equivalent biosafety procedures.

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Chapter 14 Routine Operation

Specimen Preparation
1. The Reticulocyte Package is available for use only in the
Open Sampler Mode.
2. Use reticulocyte reagent and verify the expiration date. Store
the stock reagent in the dark at room temperature.
3. Label a tube of reticulocyte reagent for each patient.
4. Verify that the whole blood specimen is warmed to room
temperature and well mixed prior to sampling.
5. Pipette 20 µL of the whole blood specimen into each labeled
tube of reticulocyte reagent.
6. Incubate the stained Reticulocyte specimens on the rotator
or in a rack, after fully inverting the stained specimens 5
times. Incubation is performed according to Reagent Package
Insert.
NOTE: The timing stated in the Reagent Package Insert
allows Reticulocyte specimens to be processed for either
STAT requests or grouped and run in batches.

Running Patient Samples


NOTE: To ensure optimal flagging, perform the CBC run
within 8 hours prior to the Retic run on the same analyzer
using the same specimen.

NOTE: Specimen IDs must match exactly and are case


sensitive.

1. Press the [RETIC RUN] key to display the RETIC RUN menu.
Press the [PATIENT SPECIMEN] key to display the RETIC PATIENT
SPECIMEN screen.
2. From the RETIC PATIENT SPECIMEN screen enter the Patient ID
and press the Enter key on the keyboard to start the search
process. The Standard Hematology Data Log for the last
8 hours will be searched for this Patient ID.
3. If the Patient ID is found, the second RETIC PATIENT SPECIMEN
screen is displayed. All the available patient demographic
information, and the RBC value, are shown on the screen.
Proceed to step 4.
If the Patient ID is found but is more than 8 hours old, the third
RETIC PATIENT SPECIMEN screen is displayed and the operator
may enter an RBC value in this screen. Skip to step 5.

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Routine Operation Chapter 14

If the Patient ID is not found, the fourth RETIC PATIENT


SPECIMEN screen is displayed and the operator may enter an
RBC value in this screen. Skip to step 5.
NOTE: If an RBC value is entered manually, the Retic run
will have incomplete flagging analysis for Excessive RBC Loss
(ERL) and Excessive Nucleated Count (ENC).

4. Press Y on the keyboard to save this demographic


information.
NOTE: If the Enter key was pressed in error, or if the patient
demographic information is incorrect, press the [CANCEL] key
to return to the first RETIC RUN screen, press the [PATIENT
SPECIMEN] key, then reenter the Patient ID. If the Patient ID
is found, skip to step 6. If not, proceed to step 5 after entering
the RBC value.

5. Press the Enter key on the keyboard to confirm and accept


this information.
6. The RETIC RUN RESULT screen is now displayed. The area in
the upper left-hand corner displays the patient demographic
information.
NOTE: The patient demographic data can be added or
edited on this screen before the specimen is run, or from the
EDIT SPECIMEN screen in the Reticulocyte Data Log after the
reticulocyte run is complete.

7. The prepared dilution(s) of the patient reticulocyte


sample(s) can be run after the control and background count
results have met the laboratory’s criteria.
8. Open the well-mixed, prepared patient reticulocyte sample
tube and immerse the Open Sample Aspiration Probe in the
sample.
9. Press the Touch Plate located behind the probe to start the
cycle. The word Busy on the Analyzer Status Indicator Panel
will be illuminated in yellow. The Status Box on the RETIC
RUN RESULT screen will display messages to indicate the
various stages of the cycle.
10. Remove the sample tube when the beep sounds. The Wash
Block moves down the probe and cleans it.
11. When the rinse cycle is complete, the Wash Block moves up
the probe. The [NEXT RETIC] key is now displayed, and the
Touch Plate is no longer active. The results of the
reticulocyte run are displayed on the screen.

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Chapter 14 Routine Operation

12. If automatic report printing has been specified, a report is


printed according to the options selected in the SET UP MENU.
If automatic report printing has not been specified, a report
may be printed by pressing the [PRINT REPORT] key. Repeat
this procedure for each subsequent reticulocyte sample.
NOTE: To obtain a color printout, the color printing option
on the CUSTOMIZE PRINTED REPORT screen must be turned
ON before entering the Reticulocyte Package.

13. Reticulocyte patient sample results can also be printed from


the RETIC DISPLAY SPECIMEN screen, available from the RETIC
DATA LOG screen.

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NOTES

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Reticulocyte Package
Chapter 14 Quality Control Guide

Quality Control Guide

The CELL-DYN 3700 System offers several quality control options


to monitor and validate instrument performance while running
the Reticulocyte Package. The options are:
• 6 QC Files Statistical and graphical analysis of the
data in each file to calculate the mean,
standard deviation, and coefficient of
variation
• Westgard Rules A multi-rule system applied to the data in
each of the QC files
Each of these options is discussed in detail in Chapter 7: Quality
Control.
All QC data should be reviewed according to your laboratory’s
protocol.

Control Material
Abbott Diagnostics recommends using the CELL-DYN control
material for performing quality control checks on the CELL-DYN
3700 System. These controls should be run:
• After daily start-up procedures are completed.
• After a reagent lot number change.
• After a service call or component replacement.
• After calibrating the Standard Hematology Mode.
• In accordance with the laboratory’s quality control
protocol.
• According to regulatory requirements.
NOTE: Data invalidating alerts, such as Fragile RBCs, are not
valid when running commercial controls.

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Quality Control Guide Chapter 14

Mixing and Handling


CAUTION: When using the reticulocyte reagent, avoid
contact with skin and clothing. This reagent contains New
Methylene Blue, which will stain skin, clothing, and many
other surfaces.

Reagent
• Use Reticulocyte Reagent prepared only by Abbott
Diagnostics. Verify the expiration date.
• Store the Reticulocyte Reagent in the dark at room
temperature.
• Use one Reticulocyte Reagent tube for each
CELL-DYN control or patient specimen.

Quality Control Specimens


Always mix and handle commercial control material according to
the directions given in the package insert. Pay particular attention
to the following:

• Store the controls in the refrigerator at 2°– 8° C. Store in


a suitable location in the refrigerator, away from the door
if it is opened frequently.
• Carefully warm the controls prior to mixing, according
to the directions given in the package insert. Proper
mixing is essential for accurate results.
• Mix the control vials gently by hand to thoroughly
resuspend the control material. Do not use automatic
mixers to resuspend the control material.
• Check the open-vial stability dating given on the package
insert and do not use the products longer than is
recommended or results may be compromised.

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Reticulocyte Package
Chapter 14 Troubleshooting

Troubleshooting

Overview
This section provides instructions for identifying,
troubleshooting, and correcting instrument alerts and conditions
in the Reticulocyte Package. All instrument conditions which
adversely affect the Standard Hematology Mode of the CELL-DYN
3700 System will also apply to the Reticulocyte Package. These
instrument conditions may be found in Chapter 10:
Troubleshooting.
This section is divided into the following subsections:
• Operational Messages and Data Flagging
• Dispersional Data Alerts
• Instrument Alert Conditions
• Alert Messages with Suppressed Reticulocyte Results
• Data Invalidating Alerts
• High Background Counts
NOTE: For a list of interfering substances, refer to Routine
Operation, Reticulocyte Specimens, Interfering Substances
within this chapter.

Operational Messages and Data Flagging


Dispersional Data Alerts
The result of each run (patient, control, or background) is
reviewed within the appropriate limits as entered by the operator
or taken from the instrument’s preset limits. If a result for a
parameter exceeds these limits, they are flagged on the screen and
on the report. Dispersional Data Alerts are displayed or printed as
follows:

Data Station Screen Display:


• Result(s) below lower limits shown in yellow
• Result(s) above upper limits shown in purple
Linearity Exceeded: Result displayed as >>>>
Reticulocyte QC Log: Result(s) outside limits underlined when
printed
Reticulocyte Data Log: Result(s) outside limits underlined when
printed
Graphics Report: Result(s) outside limits underlined

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Troubleshooting Chapter 14

Instrument Alert Conditions


Instrument Alert Conditions are messages displayed when the
instrument detects an inappropriate condition during specimen
processing. When necessary, data is suppressed. When these
messages occur, follow the instructions given, and take the
appropriate corrective action. When the problem is corrected,
repeat the specimen.

Instrument Alert Messages with Suppressed


Reticulocyte Results
Suppression of Reticulocyte results occurs when the sample run
data acquisition process exceeds normal parameters. When the
Reticulocyte results are suppressed, one of the following three
alerts will be displayed in the lower left-hand quadrant of the Data
Station screen in the Reticulocyte Package and on the graphics
printout under the heading ALERTS.

Alert Probable Cause Corrective Action


Flow Error • Air bubble 1. Run a background count to cycle air
through the system.
Note: Alert occurs
when the average 2. Rerun the Reticulocyte specimen.
count rate rapidly
increases during • Hardware 3. If alert still occurs, refer to Chapter 10:
the Reticulocyte malfunction Troubleshooting, Subsection: Trouble-
count cycle. shooting Flow Errors.
Too Few Events • Inadequate whole 1. Prepare another dilution verifying
blood sample mixing proper specimen preparation as dis-
Note: Alert occurs - Improper pipet- cussed in Routine Operation, Reticulo-
when fewer than ting cyte Specimens, Running Specimens,
3000 events are - Blood not stained Patient, Specimen Preparation within
counted during the this chapter.
Reticulocyte count
cycle. • Cold Agglutinin 2. Verify Reticulocyte results by an alter-
nate method.
>>>> (Chevrons) • The Reticulocyte 1. Verify Reticulocyte results by an alter-
percentage exceeds nate method.
the reportable linear
range.

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Chapter 14 Troubleshooting

Data Invalidating Alerts


The Reticulocyte results are not suppressed for the Data
Invalidating Alerts. The alert message appears in the lower left-
hand quadrant of the Data Station screen and on the graphics
printout under the heading ALERTS.

Alert Probable Cause Corrective Action


Fragile RBC’s • Air bubble 1. Run a background count to cycle air
through the system. Rerun the Reticulo-
NOTE: Alert occurs when cyte specimen.
the average count rate rap- 2. Prepare another dilution verifying proper
idly decreases during the specimen preparation as discussed in
Reticulocyte count cycle. • Staining a fragile RBC Routine Operation, Reticulocyte Speci-
specimen too long in mens, Running Specimens, Patient,
the reticulocyte reagent Specimen Preparation within this chap-
ter. Run the dilution after adequate incu-
bation as indicated in the Reagent
Package Insert.
• Fragile RBCs 3. Verify Reticulocyte results by an alternate
method.
Excessive RBC Loss (ERL) • Specimen staining time 1. Prepare another dilution verifying proper
too long in the specimen preparation as discussed in
reticulocyte reagent Routine Operation, Reticulocyte Speci-
mens, Running Specimens, Patient, Spec-
• Rapid degeneration of imen Preparation within this chapter,
RBCs. and run after adequate incubation as
CAUTION: The (ERL)
• High concentration of indicated in the Reagent Package Insert.
alert is functional only
platelets, platelet 2. Rerun the specimen.
when CBC results have aggregates, or other
been run on the same 3. If the flag persists, verify the reticulocyte
interfering substances.
analyzer. results by an alternative method.

• Microcytic RBCs

• Improper instrument
settings
Excessive • Too much blood added 1. Prepare another dilution using 20lL of
Nucleated Cells (ENC) to reagent tube. blood.
• High concentration of 2. Rerun the specimen. If this alert persists,
CAUTION: The (ENC) WBCs and/or NRBCs. verify Reticulocyte results by an alter-
alert is functional only nate method.
when CBC results have
been run on the same
analyzer.

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Troubleshooting Chapter 14

High Background Counts


NOTE: The background count should be less than 100
counts.

1. If the background count is high, repeat the run.


2. If the results are still unacceptable, open a new tube of
reticulocyte reagent and repeat the background count.
3. If the background count is still unacceptable, run a tube
from a new lot of reticulocyte reagent if available.
4. If the results are still unacceptable, while in the Reticulocyte
Background mode, press the Touch Plate to cycle air
through the system.
5. If the results are still unacceptable, exit the Reticulocyte
Package and perform a background check in the Standard
Hematology mode.
6. If the background in the Standard Hematology mode is
unacceptable, see Chapter 10: Troubleshooting,
Subsection: Troubleshooting High Background Counts.
NOTE: Reticulocyte counts can not be processed until the
reticulocyte background count is acceptable.

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Reticulocyte Package
Chapter 14 References

References

1. Clinical and Laboratory Standards Institute/NCCLS. Methods


for Reticulocyte Counting (Automated Blood Cell Counters, Flow
Cytometry, and Supravital Dyes); Approved Guideline – Second
Edition. CLSI/NCCLS document H44-A2 (ISBN 1-56238-527-
5) 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898,
2004.
2. Davis, BH. Immature Reticulocyte Fraction (IRF): by any
name a useful clinical parameter of erythropoietic activity.
Laboratory Hematology 2:2-8, 1996.
3. Clinical and Laboratory Standards Institute/NCCLS. Method
Comparison and Bias Estimation Using Patient Samples;
Approved Guideline – Second Edition. CLSI/NCCLS document
EP9-A2 (ISBN 1-56238-472-4) 940 West Valley Road, Suite
1400, Wayne, PA 19087-1898, 2002.
4. Clinical and Laboratory Standards Institute/NCCLS.
Evaluation of the Linearity of Quantitative Measurement
Procedures: A Statistical Approach; Approved Guideline. CLSI/
NCCLS document EP6-A (ISBN 1-56238-498-8) 940 West
Valley Road, Suite 1400, Wayne, PA 19087-1898, 2003.
5. International Committee for Standardization in
Haematology (ICSH). The Assignment of Values to Fresh
Blood Used for Calibrating Automated Cell Counters. Clinical
and Laboratory Hematology 1988; 10:203-212.
6. Clinical Applications of Flow Cytometry. ASCP National
Meeting. Spring 1990.
7. Shapiro Howard. Practical Flow Cytometry. New York: LISS.
1985.

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9140320F — April 2007
Reticulocyte Package
References Chapter 14

NOTES

14-84 CELL-DYN 3700® System Operator’s Manual


9140320C — November 2000
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American Society of Clinical Pathologists (ASCP). Clinical


Applications of Flow Cytometry. ASCP National Meeting. Spring
1990.

Bull BS, Hay KL. Are Red Blood Cell Indexes International?
Archives of Pathology and Laboratory Medicine; 109:604–606;
1985.

Bull BS, Jones AR, Gibson M, Twedt D. A Method for the


Independent Assessment of the Accuracy of Hematology
Whole Blood Calibrators. American Journal of Clinical
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Bull BS, Korpman RA. Intralaboratory Quality Control Using


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Cembrowski GS, Carey RN. Laboratory Quality Management.


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Techniques. New York: Churchill Livingstone, pp. 3-7, 1989.

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Calibrating Automated Cell Counters. Clinical and Laboratory
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International Committee for Standardization in Haematology


(ICSH). Protocol for Evaluation of Automated Blood Cell
Counters. Clinical and Laboratory Hematology; 6:69-84; 1984.

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Wayne, PA 19087-1898, 2003.

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Clinical and Laboratory Standards Institute/NCCLS. Procedures


and Devices for the Collection of Diagnostic Capillary Blood
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Clinical and Laboratory Standards Institute/NCCLS. Procedure for


Determining Packed Cell Volume by the Microhematocrit Method;
Approved Standard – Third Edition. CLSI/NCCLS document H7-
A3 (ISBN 1-56238-413-9) 940 West Valley Road, Suite 1400,
Wayne, PA 19087-1898, 2000.

Clinical and Laboratory Standards Institute. Reference Leukocyte


Differential Count (Proportional) and Evaluation of Instrumental
Methods; Approved Standard. CLSI/NCCLS document H20-A
(ISBN 1-56238-131-8) 940 West Valley Road, Suite 1400,
Wayne, PA 19087-1898, 1992.

Clinical and Laboratory Standards Institute/NCCLS. Methods for


Reticulocyte Counting (Automated Blood Cell Counters, Flow
Cytometry, and Supravital Dyes); Approved Guideline – Second
Edition. CLSI/NCCLS document H44-A2 (ISBN 1-56238-527-5)
940 West Valley Road, Suite 1400, Wayne, PA 19087-1898,
2004.

Clinical and Laboratory Standards Institute/NCCLS. Evaluation of


the Linearity of Quantitative Measurement Procedures: A
Statistical Approach; Approved Guideline. CLSI/NCCLS
document EP6-A (ISBN 1-56238-498-8) 940 West Valley Road,
Suite 1400, Wayne, PA 19087-1898, 2003.

Clinical and Laboratory Standards Institute/NCCLS. Method


Comparison and Bias Estimation Using Patient Samples;
Approved Guideline – Second Edition. CLSI/NCCLS document
EP9-A2 (ISBN 1-56238-472-4) 940 West Valley Road, Suite 1400,
Wayne, PA 19087-1898, 2002.

Shapiro Howard. Practical Flow Cytometry. New York: LISS. 1985.

Westgard JO et al. A Multi-Rule Shewhart Chart for Quality


Control in Clinical Chemistry. Clinical Chemistry, 27:3:493–
501, 1981.

Bibliography-2 CELL-DYN® 3700 System Operator’s Manual


9140320F — April 2007
Appendix A Bar Codes

Overview

This section gives a brief overview of what bar coding is, how bar
code labels are used for data entry and the different types of bar
codes that may be used with the CELL-DYN® 3700 System.
Bar coding is an automated method of gathering alphanumeric
information and transmitting it to a computer. Because it
eliminates typing and associated errors, bar coding offers speed,
increased accuracy and efficiency. The following are the major
elements in a bar coding system:
• The computer, and its software, which interpret and store
bar code data. For the CELL-DYN 3700 System, this is
accomplished by the Data Station and its software.
• The scanning device, which “decodes” the information on
the bar code labels. (The Sample Loader of a CELL-DYN
3700SL System has an integrated reader.)
• The bar code labels, which supply the specimen
identification codes.

Bar Coding Function


The bar code label contains the actual identifying data for
specimens in the form of a series of black bars and contrasting
white spaces, which represent numbers and letters. The
arrangement of the code follows one of several sets of rules for bar
code languages, called symbologies. To decode the data in the
label, a scanning device is used to pass a small spot of light over
the bars and spaces and “read” them.
Since dark bars reflect little light back into the scanning device,
while white space reflects a lot of light, a light detector inside the
scanner can translate the differences in reflection into electrical
signals. The signals are then converted into the sets of ones and
zeros (the binary system used by computers) that stand for
numbers and letters.

CELL-DYN® 3700 System Operator’s Manual Appendix A-1


9140320D — June 2003
Bar Codes
Overview Appendix A

Understanding the Label Code


In all bar code symbologies, the code consists of elements (single
bars or white spaces) and characters (groups of elements that
stand for numbers or letters). In Code 39, a commonly used
symbology, each code character contains nine elements, at least
three of which must be wide. Wide elements (whether they are
bars or spaces) in this symbology have a binary value of 1. Narrow
elements have a binary value of 0.
Most contemporary bar code systems have several features in
common. These include the following:
• The quiet zone, an area immediately before and after the bar
code symbol, which enables the scanner to read the code
properly.
• Start and stop characters, which indicate the beginning and
end of the bar code symbol. They allow the label to be
scanned from either right to left or left to right, ensuring
that code information is transmitted correctly.
• Intercharacter gaps, which act as “spaces” between each
character in the bar code symbol. Code 39 contains these
gaps. However, there are other codes, including Interleaved 2
of 5, that do not use them.
• The interpretation line, an area at the bottom of the bar code
label where human-readable information can be placed. This
may or may not be the same data as in the label code.
• The check digit, an extra numeric character in the bar code
that permits the scanning device to mathematically
determine whether it read the code correctly. This keeps the
error rate as low as one for every billion characters scanned.

Appendix A-2 CELL-DYN® 3700 System Operator’s Manual


9140320D — June 2003
Bar Codes
Appendix A Overview

Bar Code Types and Characteristics


The CELL-DYN 3700 Sample Loader reads three types of bar codes:

• Code 39
Also referred to as code 3 of 9, Code 39 encodes 43 data
characters: 0–9, A–Z, six symbols and spaces. Each character
is represented by nine elements, three of which are wide and
six of which are narrow.

• Interleaved 2 of 5
Interleaved 2 of 5 encodes the 10 numeric digits 0–9. The
name is derived from the method used to encode two
characters that are paired together. Bars represent the first
character, and the interleaved spaces represent the second
character. Each character has two wide elements and three
narrow elements, for a total of five elements.

• Codabar
Codabar uses four bars and three spaces to represent the ten
numeric digits 0–9 and certain special characters. The code is
characterized by four unique start/stop codes and variable
intercharacter spacing.

NOTE: When the check digit is on, only the letter A can
be used as a stop/start character.

• Code 128
Code 128 has 106 different printed characters. Each character
has three bars and three spaces comprising 11 modules. Each
printed character can have one of three different meanings,
depending on which of three different character sets is used.
Three different start characters tell the reader which of the
character sets is initially being used, and three shift codes
permit changing the character set inside a symbol.

CELL-DYN® 3700 System Operator’s Manual Appendix A-3


9140320D — June 2003
Bar Codes
Overview Appendix A

NOTES

Appendix A-4 CELL-DYN® 3700 System Operator’s Manual


9140320D — June 2003
Appendix A Bar Codes

Specifications

Bar Code Label Formats


The Sample Loader Bar Code Reader can read Code 39, Interleaved
2 of 5, Codabar and Code 128 formats interchangeably, provided
the check digit option is disabled. Code size, collection tube
length, and cap style limit the number of digits to the following
maximum numbers:
• Code 39 — 9 digits
• Interleaved 2 of 5 — 10 or 12 digits only
• Codabar — 10 digits
• The maximum number of digits includes any check digits
within the code. For example, if one check digit is used in
Code 39, then there are 8 digits left for the rest of the code.
• Code 128 — 11 digits

Bar Code Check Digit Formats


Bar code check digits are used whenever the Sample Loader is to
read a specific type of bar code. (To enable or disable check digits,
refer to Chapter 5: Operating Instructions, Subsection: Bar Code
ON/Bar Code OFF Soft Key.) Check digit specifications are:
Code 39: The modulus 43 sum of all the
character values in a given message.
Interleaved 2 of 5: The check digit is the complement of
the weighted sum of the digits modulo
10. To weight the digits, multiply every
other digit by 3, starting with the first.
Codabar: The check digit is the 16-(sum of
character values modulo 16).
Code 128: The check digit is included and always
on.
NOTE: If a specific check digit option is selected and
enabled, the Sample Loader will read only bar codes in that
specific format. If there is more than one format to be
read, it is recommended that the check digit option be
disabled.

CELL-DYN® 3700 System Operator’s Manual Appendix A-5


9140320D — June 2003
Bar Codes
Specifications Appendix A

Bar Code Label Specifications


Bar code labels (shown in the following figure) must be printed
on good quality label stock and must meet the following
specifications:
• 0.25 inch minimum quiet zone on each end
• 0.01 inch (10 mils) minimum narrow bar width
• 2:1 to 3:1 wide to narrow bar ratio
• 0.5 inch minimum bar length
• 2 inch maximum label length
• 1.25 inch maximum label width
• Maximum possible contrast between bars and background label

Maximum Label Width


1.25 inches

Minimum
Quiet Zone Maximum
0.25 inches Label Length
2.0 inches

Minimum Bar Length


0.5 inches
Figure A.1: Bar Code Label Specifications

Appendix A-6 CELL-DYN® 3700 System Operator’s Manual


9140320D — June 2003
Bar Codes
Appendix A Specifications

CELL-DYN Bar Code Labels


CELL-DYN 4-digit Code 39 bar code labels are available for the
Sample Loader. These labels may be used for positive specimen
identification when laboratory-generated bar code labels are
unavailable.

CELL-DYN Q Labels
Special bar code labels are available to identify QC specimens.
These “Q” labels (numbers Q1–Q20) automatically select QC files
1 to 20, and therefore should be used to process only QC
specimens.

CELL-DYN® 3700 System Operator’s Manual Appendix A-7


9140320E — September 2004
Bar Codes
Specifications Appendix A

Bar Code Label Placement


The following two guidelines should be observed when placing
bar code labels on specimen tubes:
• All labels should be placed on the tubes securely and without
flaps sticking out. (See the following figure.) Excessive
numbers of labels may prevent tubes from mixing properly.
• The bar code label should be placed on the tube just below
the stopper with the bars perpendicular to the length of the
tube so that the entire bar code can be viewed through the
slot in the rack as the tube rotates. Be sure that at least 0.10
inch (about 1/8 inch) of space is left between the bottom of
the rack slot and the bar code symbol, as well as between the
bottom of the tube cap and the bar code symbol, to satisfy
the “quiet zone” requirement. See the following figure for
proper placement.
NOTE: The bar code reader searches for a readable code
when it reads a bar code label. It then performs multiple
reads to verify that the code has been read correctly. If a
second bar code label from a different patient is applied to
the tube, it may be ignored by the bar code reader.
Consequently, the possibility for misidentification exists.
Good laboratory practice mandates that each specimen is
labeled with information traceable to one patient only.
Therefore, it is recommended that only one bar code label
is used on each tube for correct specimen identification.

Properly Labeled Tubes


Top Surface
Should Be Dry
Bar Code
Label
Clear
Tape

Exposed
Bottom

Improperly Labeled Tubes


16.5 mm
Flap
Diameter
Width Limit for
Multiple Labels High
Collar
Edges
Peeled
Loose

Tail
Figure A.2: Tube Labeling Requirements

Appendix A-8 CELL-DYN® 3700 System Operator’s Manual


9140320E — September 2004
Appendix A Bar Codes

Acknowledgment

The authors wish to acknowledge Computype, Inc. of St. Paul,


Minnesota for providing their booklet “Bar Coding and
Productivity” to assist in the writing of this chapter.

CELL-DYN® 3700 System Operator’s Manual Appendix A-9


9140320D — June 2003
Bar Codes
Acknowledgment Appendix A

NOTES

Appendix A-10 CELL-DYN® 3700 System Operator’s Manual


9140320D — June 2003
Appendix B Parts List

Overview

This section lists the part numbers of components, accessories,


controls, reagents, and consumables associated with the
CELL-DYN 3700 System for user convenience when placing orders.
To place an order for these products or obtain technical assistance
for your CELL-DYN System, contact Abbott Diagnostics Customer
Service at 1-877-4ABBOTT (1-877-422-2688).

CELL-DYN 3700 Accessories


List numbers are unique identifiers used when ordering products.
List numbers and quantities provided in this Operator’s Manual
are intended for guidance only and are subject to change. US
Customers, contact Abbott Diagnostics Customer Service at
1-877-4ABBOTT (1-877-422-2688) for the most current
information regarding list numbers. Customers outside the US,
contact your local Customer Service Representative.

Table B.1 CELL-DYN 3700 Accessories Kit (List Number 06H88-01)

Part/List
Number Quantity Description

02H33-01 1 CD 3700 Interface Specification

*1403216 1 Keyboard Cover

20005-01 1 6ft Interface Cable

21704-01 1 Waste Sensor Dummy Plug

*2400502 1 Cord Power, 125V

*3001008 1 Computer Printer Paper 8-1/2" X 11"

*5100165 2 Fuse, 8 Amp T (Slo-Blo)

*5100201 2 Fuse Fast, 1.6 Amp

*5406754 1 Allen Wrench, Hex, Short “L” 7

54305-01 1 Aperture Brush

*5100164 2 Fuse, 4 Amp T (Slo-Blo)

70048-01 1 Allen Wrench

91482-01 1 Reagent Line Kit

* Available only to Abbott Personnel.

CELL-DYN® 3700 System Operator’s Manual Appendix B-1


9140320E — September 2004
Parts List
Overview Appendix B

Table B.1 CELL-DYN 3700 Accessories Kit (List Number 06H88-01) (Continued)

Part/List
Quantity Description
Number

91484-01 2 Peristaltic Pump Tubing- Small

91485-01 1 Peristaltic Pump Tubing- Medium

9212230 1 Sample Aspiration Tubing (Sample Loader)

92532-01 1 Serial Loop Back Device

03H99-01 1 CD 3700 SL Needle

03H96-01 1 Solenoid Ring Pull

95519-01 1 Data Station Cable

03H98-02 1 Waste Bottle Cable

Table B.2 CELL-DYN 3700 Sample Loader Accessories Kit

List Number Quantity Name Comments

04H91-04 1 set Sample Loader Racks Set of 11 Sample Loader racks pre-
labeled with tube position numbers
and rack number label

Appendix B-2 CELL-DYN® 3700 System Operator’s Manual


9140320E — September 2004
Parts List
Appendix B Overview

CELL-DYN 3700 Optional Accessories


Table B.3 CELL-DYN 3700 Optional Accessories
Part/List
Quantity Name Description
Number
25860-01 1 Bar Code Label Dispenser Dispenser for Bar Code Label rolls
99650-01 1 Bar Code Tube ID Labels, 1 roll Tube ID Bar Code Labels (1000
labels per roll)
99652-01 1 QC Bar Code Labels QC Bar Code Labels (Numeral 1-
20), in Code 39 (without check digit)
04H34-01 1 Syringe, 10 mL For dispensing Diluent reagent
28561-01 1 Syringe, 2.5 mL For dispensing WIC/HGB Lyse
reagent
28560-01 1 Syringe, 500 µL For injecting diluted sample into
optical flow cell
03H99-01 1 Needle, Vent/Aspiration For venting/aspirating samples in
Closed Mode
06H89-01 1 Operator’s Manual English Version
03H76-01 1 CELL-DYN 3700 Shear Valve Ceramic Center Section for
Center Section CELL-DYN 3700 Blood Shear Valve
99644-01 1 Enzymatic Cleaner
99624-01 Pre-Printed Tickets

CELL-DYN® 3700 System Operator’s Manual Appendix B-3


9140320D — June 2003
Parts List
Overview Appendix B

Table B.4 CELL-DYN 3700 Calibrators and Controls

List Number Quantity Name Description

99120-01 1 CELL-DYN® 22 CALIBRATOR 2 x 2.5 mL tubes

08H57-01 1 CELL-DYN HemCal® Calibrator 2 x 3.0 mL vials

93111-01 1 CELL-DYN 22® Tri-Level Control 12 x 2.5 mL tubes

99106-01 1 CELL-DYN® 22 Tri-Level Control, half pack 6 x 2.5 mL tubes

99103-01 1 CELL-DYN® 22 Normal Level Control 6 x 2.5 mL tubes

01H91-01 1 CELL-DYN® 22 Control Assay Disk Diskette

08H58-01 1 CELL-DYN® 29 Plus Control (with Retic) 12 x 3.0 mL vials

08H58-02 1 CELL-DYN® 29 Plus Control (with Retic), half pack 6 x 3.0 mL vials

08H64-01 1 CELL-DYN® 29 Plus Control (with Retic), Assay Disk Diskette

08H62-01 1 CELL-DYN® Retic Plus Control 10 x 3.0 mL vials

Table B.5 CELL-DYN 3700 Reagents

List Number Quantity Name Single Container Size QTY/ Case

99231-01 1 Diluent Reagent 20 L cubitainer 1/case

99311-01 1 Sheath Reagent 9.6 L cubitainer 1/case

03H62-01 1 CN free HGB/WIC Lyse 3.8 L cubitainer 1/case


Reagent

99431-01 1 HGB/WIC Lyse Reagent 3.8 L cubitaner 1/case

99321-01 1 Detergent Reagent 20 L cubitainer

03H40-01 1 Reticulocyte Reagent 5.0 mL tubes, each tube Kit of 100


containing 3.7 mL of
reagent

Appendix B-4 CELL-DYN® 3700 System Operator’s Manual


9140320F — April 2007
Appendix C

Appendix C

This table provides a detailed list of interfering substances. Note


that some of the substances listed may not interfere with
CELL-DYN 3700 results. Refer to the list of interfering substances
provided in this manual in Section 3: Principles of Operation,
Subsection: Operational Messages and Data Flagging and in
Section 5: Operating Instructions, Subsection: Sample
Collection and Handling, for the substances that commonly
interfere with CELL-DYN 3700 results.

Parameter Causes of Spurious Increase Causes of Spurious Decrease


White Cell Count (WBC) Cryoglobulin, cryofibrinogen Clotting
Heparin Smudge cells
Monoclonal proteins Uremia plus immunosuppressants
Nucleated red cells
Platelets clumping
Unlysed red cells
Red Cell Count (RBC) Cryoglobulin, cryofibrinogen Cold agglutinins
Giant platelets Clotted specimen (microclot)
Elevated white cell count Hemolysis (in vitro)
(> 30,000/μL) Polycythemia (increased RBC
coincidence)
Microcytic red cells
Hemoglobin (HGB) Carboxyhemoglobin (> 10%) Clotted specimen (microclot)
Cryoglobulin, cryofibrinogen
Hemolysis (in vivo)
Elevated white cell count (>30,000/μL
Hyperbilirubinemia, severe Lipemia
Abnormal plasma proteins
Hematocrit Hyponatremia Excess EDTA
(Packed Cell Volume − Manual Method) Plasma trapping Hemolysis (in vitro)
Hypernatremia
Mean Cell Volume Autoagglutination Cryoglobulin, cryofibrinogen
High white cell count Giant platelets
(>50,000/μL) Hemolysis (in vitro)
Hyperglycemia Microcytic red cells
Reduced red cell deformability
Swollen red cells
Mean Cell Hemoglobin High white cell count Spuriously low hemoglobin
(> 50,000/μL) Spuriously high red cell count
Spuriously high hemoglobin
Spuriously low red cell count
Mean Cell Hemoglobin Concentration Autoagglutination High white cell count
Clotting (> 50,000/μL)
Hemolysis (in vivo and in vitro) Spuriously low hemoglobin
Spuriously high hemoglobin Spuriously high red cell count
Spuriously low hematocrit
Platelets (PLT) Cryoglobulin, cryofibrinogen Clotting
Hemolysis (in vivo and in vitro) Giant platelets
Microcytic red cells Heparin
Red cell inclusions Platelet clumping
White cell fragments Platelet satellitosis

Source:
• Cornbleet J. Spurious Results from Automated Hematology Cell Counters. Laboratory
Medicine 1983; 14:509-514.

CELL-DYN® 3700 System Operator’s Manual Appendix C-1


9140320E — September 2004
Appendix C

NOTES

Appendix C-2 CELL-DYN® 3700 System Operator’s Manual


9140320E — September 2004
Index

Numerics C
10-mL Reagent Syringe 9-37 Calibrating All Parameters 6-43, 6-54, 6-80
Calibrating Individual Parameters 6-44, 6-55,
A 6-81
Abbott Instrument Warranty iii Calibrating the Closed Mode 6-90
Accessing the Maintenance Log 9-8 Calibrating the Open Mode 6-65
Accessing the Shear Valve 9-9 Calibration Backup 6-95
Accuracy 13-6 Calibration Factor Calculation 6-40, 6-50, 6-77,
Acknowledgment A-9 6-90
Adding a New Configuration File 13-34 Calibration Factor Calculations 6-62
Adding New Animal Types 13-33 Calibration Guidelines 6-27
Analyzer Air Filters 9-32 Calibration Log Soft Key 6-18
Analyzer Flow Panel Components Diagram 9-2 Calibration Materials 6-3
Analyzer 1-6 Calibration Menu 6-13
Aperture Plates 9-39 Calibration Menu Flowchart 6-13
As Required 9-37 Calibration Methods 6-3
Auto-Cal Calibration Criteria Worksheet 6-45, Calibration Procedural Summary 6-11
6-57 Calibration Requirements for Auto-Cal 6-35
Auto-Cal Methodology 6-34 Calibration Screen 6-14
Auto-Cal Mode to Mode Calibration 6-71 Calibration 13-27
Auto-Cal Overview 6-33 Calibrator 1-27
Auto-Cal Sample Capacity 6-34 Carryover 13-7
Auto-Cal Using Calibrator 6-37 Cell Populations and Flagging 3-45
Auto-Cal Using Whole Blood 6-47 CELL-DYN 3700 Accessories B-1
Auto-Calibrate Soft Key 6-19 CELL-DYN 3700CS System Specifications 4-3,
Auto-Clean 9-19 4-9
CELL-DYN Bar Code Labels 12-3, A-7
B CELL-DYN Controls 7-27
CELL-DYN Q Labels 12-3, A-7
Bar Code Check Digit Formats A-5
Chemical Hazards 8-4
Bar Code Label Formats A-5
Closed Mode Calibration Confirmation 6-72
Bar Code Label Placement 12-3, A-8,
Closed Sampler Aspiration Needle 9-22
Bar Code Label Specifications A-6
Closed Sampler Tube Retainer Adjustment (CS
Bar Code Labels 12-3
System Only) 9-51
Bar Code Reader Window 9-46
Coincidence Passage Correction 3-27
Bar Code Specifications 4-7
Collecting the Calibration Data 6-38, 6-48, 6-75
Bar Code Types and Characteristics A-3
Combined Specifications for the SL and
Bar Coding Function A-1
CS Systems 4-13
Baso Box Setup 13-46
Completing Manual Calibration 6-66
Bibliography Bibliography-1
Completing Mode to Mode Calibration 6-82,
6-91
Completing Open Mode Calibration 6-44

CELL-DYN® 3700 Operator’s Manual Index - 1


9140320F — April 2007
Completing Whole Blood Open Mode F
Calibration 6-55 Flagging Diagnostics Screen 3-57
Control Material 14-77 Flagging Summary 3-49
Controls and Calibrator 1-27 Flagging 13-8
Controls 1-27 Flushing the “Y” Fitting — Open and Closed
Conventions Used in this Chapter 6-11 Modes 9-47
Conventions Used in This Manual xiv, 5-5 Foreword i
Customer Support i Function Sequence 12-12
Customize Report Soft Key 5-51 Functional Description 12-9
Customizing the Display 13-36
G
D General 8-3
Daily Maintenance Procedures 9-19 Graphics Printing 11-3
Data Log Menu 5-122 Guidelines 6-60
Data Log Set Up Procedures 5-135
Data Review from the Data Log 5-140 H
Data Review from the Retic Data Log 14-37
Handling and Disposing of Biohazardous
Data Station Program Overview 5-2
Materials 8-4
Data Station 1-19
Hazard Information and Precautions 8-3
Date/Time Soft Key 5-14
Hemoglobin Analysis 3-6, 3-35
Decontamination Procedures 9-4
Hemoglobin Flow Cell Manual Cleaning 9-43
Determining Reference Values 6-73
Hemoglobin Measurement Process 3-35
Determining the Calibration Factors for MCV
HGB Parameters 3-36
and MPV 13-29
High Background Counts 14-82
Determining the Closed Mode Mean 6-86
Determining the Open Mode Mean 6-61, 6-85
I
Determining the Variance 13-39
Determining Which Parameters Need Initial Preparation 2-3
Calibration 6-41, 6-52, 6-63, 6-78, 6-88 Installation 2-7
Diagnostics Menu Flowchart 10-4 Instrument Disclaimer ii
Diagnostics Menu 10-3 Instrument Fault and Status Messages 3-37
Disabling/Enabling the Analyzer 9-9 Instrument Installation 2-13
Draining the Reagent Reservoirs 9-7 Instrument Labeling viii
Instrument Logbook 5-1
E Instrument Rinsed 3-7
Instrument Start Up 5-92
Electrical Hazards 8-5
Intended Use i, 1-3
Electrical Impedance Measurements 3-27
Interpretive Messages 3-58
Emptying the Transducers 9-6
Interval Set Up Procedure 9-15
Enter Factor Soft Key 6-16
Introduction to WBC Flagging 3-41
Entering the Calibration Factor 13-29
Introduction 10-1, 3-37, 13-1, 13-5
Entering the Reference Values 6-37, 6-48, 6-74
Inventory 2-3
Examples of Customer-Defined Default Codes
13-50
Extended Auto Clean 9-28, 9-35

Index - 2 CELL-DYN® 3700 Operator’s Manual


9140320F — April 2007
L P
Laser Hazards 8-6 Package Inspection 2-3
Linearity 13-7 Parameter Flagging Messages 3-38
List of Messages and Fault Conditions 10-66 Patent Statement ii
List of Symptoms 10-38 Patient Limits Soft Key 5-16
Loading Blank (Continuous-Feed) Tickets 11-8 Percent Difference Calculation 6-87
Loading Individual Tickets 11-7 Performance Characteristics 4-20, 13-5
Performance Specifications 4-15
M Physical and Mechanical Hazards 8-6
Main Module 12-5 Physical Specifications 4-3, 4-9
Main Soft Key 6-16 Pictorial Disclaimer ii
Maintenance 11-11, 12-17 Platelet Flagging 3-34
Maintenance Log Set Up 9-13 PLT Measurement Process 3-32
Manual Calibration Overview 6-59 PLT Parameters 3-33
Manual Calibration Procedure — Open Mode Post-Calibration Procedures 6-95
6-61 Power Requirements 2-5
Manual Calibration Worksheet 6-68 Power Specifications 4-4, 4-10
Manual Mode to Mode Calibration (CS or SL) Pre-Calibration Procedures Checklist 6-29
6-85 Pre-Calibration Procedures 6-27, 13-28
Manual Mode to Mode Calibration Worksheet Precision 13-5
6-93 Preparation for Inactivity or Shipping 9-52
Manual Mode to Mode Calibration 6-72 Preparing for Manual Calibration 6-61
Measurement Specifications 4-13 Preparing for Manual Mode to Mode Calibration
Menu Flowcharts 5-6 6-85
Messages and Fault Conditions 10-68 Preparing the Samples 13-38
Mixing and Handling 14-78 Preventive Maintenance Schedule 9-2
Mode To Mode Auto-Cal Calibration (Closed Principles of Operation 13-3, 14-7
Sampler Only) 6-73 Print Soft Key 6-15
Mode to Mode Auto-Cal Calibration Criteria Printer Installation 2-7
Worksheet 6-83 Printer 1-23
Mode To Mode Calibration Overview 6-71 Procedure: MCV or MPV Calibration 13-28
Mode to Mode Calibration Preparation 6-72 Proprietary Statement ii
Monthly Maintenance Procedures 9-29
Q
O QC Set Up Menu Soft Key 5-21
Open and Closed Modes 6-2 Quality Control Guide 7-15, 14-77
Open Sampler/Closed Sampler Soft Key 6-15 Quality Control Menu Flowchart 7-2
Operating Instructions 13-9 Quality Control Menu 7-3
Operating Principles 12-9 Quality Control 6-95, 13-31
Operating Tips 12-15
Operation Set Up Soft Key 5-43
Operational Messages and Data Flagging 3-37,
14-79
Operational Specifications 4-6, 4-11
Optional Calibration Confirmation 6-82, 6-91
Other Chapters to Reference 12-17

CELL-DYN® 3700 Operator’s Manual Index - 3


9140320F — April 2007
R Sample Aspiration 3-3
RBC Flagging 3-31 Sample Collection and Handling 5-87
RBC Parameters 3-30 Sample Loader Aspiration Needle 9-21
RBC/PLT Analysis 3-6, 3-27 Sample Loader Components 12-5
RBC/PLT Measurement Process 3-29 Sample Loader Set Up 2-10
Reagent Log Soft Key 5-19 Sample Loader Tray, Racks, and Safety Cover
Reagent Syringes 9-29 9-27
Reagent System 1-23 Sample Loader 1-23
References 3-61, 4-25, 5-143, 6-99, 7-29, 8-11, Selecting the Animal 13-22
13-55, 14-83 Self-Test Printouts 11-4
Related Symbols xiii Set Up Instructions 5-13
Relocation 2-17 Set Up 12-17
Repackaging for Shipment 9-54 Shear Valve 9-23
Replaceable Components 10-32 Space Requirements 2-4
RER 3-28 Special Procedures 9-51
Results Displayed 3-7 Special Protocols Menu 9-5
Retic Data Log Menu 14-30 Special Protocols Screen #2 9-10
Retic Main Menu 14-14 Specifications A-5
Retic Menu Options 14-9 Starting Auto-Cal 6-37, 6-47, 6-74
Retic QC Log Menu 14-39 Suspect Parameter Flags 3-50
Retic Run Menu 14-57 Suspect Population Flags 3-53
Retic Run Menu Flowchart 14-56 Symbols v
Retic Set Up Menu 14-16 Symptom Identification and Resolution 10-39
Retic Special Protocols Menu 14-52 System Components 1-5
Reticulocyte Analysis 3-6
Reticulocyte Reagent System 1-26 T
Reticulocyte Specimens 14-67 The Animal Catalog 13-3
Reticulocytes 3-32 Ticket Printing 11-5
Revision Log xviii Tower Unit 12-7
Revision Status xvii Trademark Statements iv
Routine Operating Procedures 12-15 Troubleshooting Guide 10-27
Routine Operation 5-67, 13-21, 14-55 Troubleshooting Procedures 10-29
Run Menu 5-68 Troubleshooting 11-13, 12-17, 14-79
Run Screen Soft Keys 5-74 Turning on the Gains Template 13-37
Run Screen 13-21 Turning the Reticulocyte Package ON and OFF
Running Controls 7-15 14-10
Running the Samples 13-38 Turning The Vet Package Off 13-53

S U
Safety Agency Approvals iv Unclogging the Open Sample Aspiration Probe
Safety xvi 9-45
Sample Analysis Cycle Overview 3-5 Understanding the Label Code A-2
Sample Analysis Using the CS Model 5-99 Units Selection Soft Key 5-49
Sample Analysis Using the SL Model 5-92 Update Maintenance Log Procedure 9-16
Sample Analysis Using the Work List 5-114 Using The Data Log 5-121
Sample Analysis 5-89 Using The Work List 5-103
Sample Aspiration Peristaltic Pump Tubing 9-26

Index - 4 CELL-DYN® 3700 Operator’s Manual


9140320F — April 2007
V WBC Parameters 3-25
Vet Package Keys 13-10 Weekly Maintenance Procedures 9-23
Vet Package Suggestions 13-49 Westgard Rules 7-17
View QC Log Soft Key 7-8 When to Calibrate 6-1
Volumetric Metering 3-28 WIC Measurement 3-10
WIC/WOC Interaction 3-9
W WOC Analysis 3-13
WOC Transfer Peristaltic Pump Tubing 9-33
Warning Conventions 8-1
Waste Requirements 2-5
WBC Analysis 3-5, 3-9 X
WBC Descriptors 3-49 X-B Analysis 7-20
WBC Differential Analysis 3-19 X-B File Soft Key 7-4
WBC Flagging 3-26

CELL-DYN® 3700 Operator’s Manual Index - 5


9140320F — April 2007
NOTES

Index - 6 CELL-DYN® 3700 Operator’s Manual


9140320F — April 2007

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