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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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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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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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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
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 . . . . . . . . . . . . . . . . . . . . . . . Figure 3.2: WOC Flow Cell . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 3.3: WBC Light Scatter . . . . . . . . . . . . . . . . . . . . . . . . . Figure 3.4: Optical Bench Assembly . . . . . . . . . . . . . . . . . . . . Figure 3.5: Mononuclear-Polymorphonuclear Scatter . . . . . . Figure 3.6: Neutrophil-Eosinophil Scatter. . . . . . . . . . . . . . . . Figure 3.7: Mononuclear Scatter . . . . . . . . . . . . . . . . . . . . . . . Figure 3.8: WBC Histograms . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 3.9: WBC Data and Scatterplots . . . . . . . . . . . . . . . . . . Figure 3.10: Volumetric Metering . . . . . . . . . . . . . . . . . . . . . . Figure 3.11: RBC Data and Histogram. . . . . . . . . . . . . . . . . . . Figure 3.12: PLT Data and Histogram . . . . . . . . . . . . . . . . . . . Figure 3.13: Flagging Diagnostics Screen . . . . . . . . . . . . . . . . Figure 3.14: Scatterplot with Increased Stroma in the N1 Region . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11 3-14 3-15 3-17 3-20 3-21 3-22 3-24 3-25 3-28 3-30 3-33 3-41 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

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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

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List of Figures

Figure 5.46: Data Log Screen Showing Accept Into X-B Key Figure 5.47: Customize Display for Data Log Screen . . . . . . Figure 5.48: Customize Display Showing Standard Groups . Figure 5.49: Customize Printout for Data Log Screen . . . . . Figure 5.50: Print Data Log Screen . . . . . . . . . . . . . . . . . . . . Figure 5.51: Customize Display for Data Log Screen Showing Standard Groups . . . . . . . . . . . . . . . . . . . . . . . . Figure 5.52: Customize Printout for Data Log Screen Showing Customized Print Group . . . . . . . . . . . . . . . . . . Figure 5.53: Display Specimen Screen . . . . . . . . . . . . . . . . . Figure 5.54: Edit Specimen Screen . . . . . . . . . . . . . . . . . . . .

5-128 5-129 5-130 5-132 5-134 5-135 5-138 5-140 5-142

Figure 6.1: Calibration Screen Displaying Open Mode Calibration Factors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 6.2: Calibration Menu Screen Displaying Closed Mode Calibration Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 6.3: Enter Calibration Factor Screen . . . . . . . . . . . . . . Figure 6.4: Calibration Log Screen . . . . . . . . . . . . . . . . . . . . . Figure 6.5: Auto-Calibration Screen for CELL-DYN 3700CS System . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 6.6: Whole Blood Auto-Cal Screen. . . . . . . . . . . . . . . . Figure 6.7: Whole Blood Auto-Cal Screen. . . . . . . . . . . . . . . . Figure 6.8: Whole Blood Auto-Cal Results Screen . . . . . . . . . Figure 6.9: Whole Blood Auto-Cal Results Screen with Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 6.10: Calibrator Auto-Cal Screen . . . . . . . . . . . . . . . . . Figure 6.11: Latex Auto-Cal Screen . . . . . . . . . . . . . . . . . . . . .

6-14 6-15 6-16 6-18 6-19 6-20 6-22 6-23 6-24 6-25 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

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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

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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 . . . . . . . . . . . . . . . . . . . . . . Figure 14.2: Operation Set Up Menu Screen with Reticulocyte Package Enabled. . . . . . . . . . . . . . . . . . . . . . Figure 14.3: Reticulocyte Main Menu Screen . . . . . . . . . . . . Figure 14.4: Reticulocyte Set Up Screen . . . . . . . . . . . . . . . . Figure 14.5: Reticulocyte Patient Limits Screen . . . . . . . . . . Figure 14.6: Reticulocyte QC Set Up Screen . . . . . . . . . . . . . Figure 14.7: Retic QC Range Entry Screen . . . . . . . . . . . . . . Figure 14.8: Retic QC Means/Limits Screen . . . . . . . . . . . . . Figure 14.9: Retic Set Up QC Screen . . . . . . . . . . . . . . . . . . .

14-10 14-12 14-14 14-16 14-18 14-19 14-21 14-22 14-25

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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

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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. . . . . . . . . . . . . . . . . . . . . . . . . Table 6.2: Calibration Criteria. . . . . . . . . . . . . . . . . . . . . . . . . Table 6.3: Calibration Criteria. . . . . . . . . . . . . . . . . . . . . . . . . Table 6.4: Mode to Mode Calibration Criteria . . . . . . . . . . . . Table 6.5: Mode to Mode Calibration Criteria . . . . . . . . . . . . 6-41 6-51 6-63 6-78 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Table 13.2: Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Table 13.3: Linearity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Table 13.4: Carryover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-5 13-6 13-7 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 Operators Manual

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List of Tables

NOTES

Master Table of Contents-18

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Introduction

Foreword

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 Operators Manual

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.

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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 Operators Manual. 4. Result from maintenance, repair, or modification performed without Abbotts authorization. Abbotts 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 Abbotts 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.
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Safety Agency Approvals


In Vitro Diagnostic Directive Legal Manufacturer Authorized Representative 98/79/EC Abbott Laboratories Abbott Park, Il 60064 USA ABBOTT Max-Planck-Ring 2 65205 Wiesbaden, Germany

UL 61010A-1 IEC 1010-1

Approved Approved

CSA C22.2 No. 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

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Specific Instrument Symbols


AC INPUT ALARM AUTO LOADER AUTO SAMPLER BUSY COM 1 COM 2 DATA STATION E/STOP FAULT FREQUENCY FUSES HDD HGB FLOWCELL HSSL INIT INSTALLATION DISK KEYBOARD LINE FREQ SELECT LINE VOLTAGE SELECT LPT1 LPT2 MAN MAX POWER MIXING CHAMBER

Alternating Current Input Alarm Auto Loader Auto Sampler Busy Communications Port 1 Communications Port 2 Data Station Emergency Stop Fault Frequency Fuses Hard Disk Drive Hemoglobin Flowcell High Speed Serial Link Initialize Installation Disk Keyboard Line Frequency Select Line Voltage Select First Parallel Printer Port Second Parallel Printer Port Manual Mode Maximum Power Mixing Chamber

MODEL MONITOR PAUSE PERISTALTIC PUMP POWER RBC METERING RBC TRANSDUCER READY REPEAT RESET REV RS232 SERVICE DISK SET-UP DISK SN SOL START TEST INTERFACE TOUCH WASTE WASTE CHAMBER 1 WASTE CHAMBER 2 WASTE SENSOR WIC METERING WIC TRANSDUCER

Model Number Monitor Pause Peristaltic Pump Power RBC Metering Assembly RBC Transducer Assembly Ready Repeat Reset Revision Recommended Specification 232 Service Disk Set-up Disk Serial Number Solenoid Start Test Interface Touch Waste Waste Chamber 1 Waste Chamber 2 Waste Sensor WBC Impedance Count Metering Assembly WBC Impedance Count Transducer Assembly

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Reagent related
CN-FREE HGB/WIC LYSE DETERGENT DILUENT ENZYMATIC CLEANER CONCENTRATE HGB HGB LYSE HGB/WIC LYSE LOT SHEATH
8oC 2 oC

Cyanide-Free Hemoglobin/WBC Impedance Count Lyse Reagent Detergent Reagent Diluent Reagent Enzymatic Cleaner Concentrate Hemoglobin Hemoglobin Lyse Reagent Hemoglobin/WBC Impedance Count Lyse Lot Number Sheath Reagent Storage temperature. (Example shows Store at 28C)

Use by / Expiration Date


WBC LYSE

WBC Lyse Reagent

Calibrator/Control related
ASSAY VALUE CONTROL CONTROL ASSAY CONTROL L N H CONTROL L CONTROL N CONTROL H CONTROL I CONTROL II MEAN RANGE MEAN VALUE PARAMETER RETIC CONTROL

Assay Value Control Control Assay Disk Control, Tri-Level Control, Low Control, Normal Control, High Control, Level I Control, Level II Mean Range Mean Value Parameter Reticulocyte Control
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Calibrator/Control related
SYSTEM WB CONTROL L WB CONTROL N WB CONTROL H WB CONTROL TRI-LEVEL WB CAL WB CONTROL

System Whole Blood Control, Low Whole Blood Control, Normal Whole Blood Control, High Whole Blood Control, Tri-Level Whole Blood Calibrator Whole Blood Control

Miscellaneous Legal Manufacturer Manufacturer

Consult instructions for use

Date of Manufacture Authorized Representative For In Vitro Diagnostic Use List Number Separate collection for electrical and electronic equipment waste per Directive 2002/96/EC in the European Union

EC REP IVD REF

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Instrument Labeling
The following labels are affixed to the CELL-DYN 3700 System: Current CELL-DYN customers 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.
MADE IN U.S.A.

REV
PN 9230308 REV E

Serial Number Label, Rear Panel viii


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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 une tension de rseau diffrente est requise, reportez-vous au Manuel Technique pour de plus amples informations. ADVERTENCIA: CONFIGURADO PARA 120 VOLTIOS Si se necesita otra tensin diferente a la indicada, consulte el Manual de Operaciones para instrucciones ms detalladas. AVVERTENZA: CONFIGURATO PER 120 VOLT Se la tensione 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 OPERATORS MANUAL FOR INSTALLATION PROCEDURE.
PN 9230334

Solution Container Label, Rear Panel

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New CELL-DYN customers 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


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ABBOTT LABORATORIES Abbott Park, IL 60064 USA

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


CE Mark Label, Rear Panel

PN 9230751A

AVVERTENZA: CONFIGURATO A 120 VOLT / AVISO: CONFIGURADO PARA 120 VOLTS / ADVARSEL: KONFIGURERET TIL 120 V / VARNING: INST LLD F R 120 VOLT / : 120 VOLTS

WARNING: SET FOR 120 VOLTS / ACHTUNG: F R 120 VOLT EINGESTELLT / MISE EN GARDE : UTILISATION A 120 VOLTS / ADVERTENCIA: 120 VOLTIOS /

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 diff rente est requise, consulter les instructions dutilisation. / Consulte las instrucciones de uso si la tensi n es distinta. / Per un voltaggio diverso, consultare le istruzioni per luso. / Se for necess ria uma voltagem diferente, consultar as instru es de utiliza o. / Se brugermanualen, hvis der er behov for drift med en anden netspnding. / L s tillh rande dokumentation om en annan sp nning beh vs. / , . PN 9230003F

Voltage Label, Rear Panel

CAUTION: Do not handle Solution Container unless properly protected.


VORSICHT: Die Reagenzbeh

appropri e. PRECAUCI N: no maneje el recipiente de la soluci n a menos que est protegido adecuadamente. ATTENZIONE: Non maneggiare il recipiente della soluzione se non si protetti in modo adeguato. ATEN O: n o manipular o recipiente da solu o sem estar devidamente protegido. VIGTIGT: Beholderen med oplsning m ikke h ndteres, medmindre brugeren er korrekt beskyttet. VIKTIGT: Anv nd skyddskl der vid hantering av l sningsbeh llarna. : . UPOZORNN: Nemanipulujte s ndobou obsahujc roztok, pokud nen dn zabezpeena.
Consult instructions for use. / Gebrauchsanweisung beachten. / Consulter les instructions dutilisation. / Consulte las instrucciones de uso. / Consultare le istruzioni per luso. / Consultar as instru es de utiliza o. / Se brugsanvisningen. / L s tillh rande dokumentation. / . / Viz nvod k pouit.

ATTENTION : Ne pas manipuler le flacon de solution sans protection

lter nur ordnungsgem gesichert bewegen.

PN 9230334F

Solution Container Label, Rear Panel

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ABBOTT LABORATORIES Abbott Park, IL 60064 USA

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


Small CE Mark Label, Rear of Data Station

PN 9230751A PN 9230963

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

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Conventions Used in This Manual


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

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


MAIN MENU KEYS

SUBMENU KEYS

TOGGLE KEYS TOGGLE KEYS

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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 DATA LOG

QUALITY 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 DATA LOG

QUALITY CONTROL

PATIENT LIMITS

REAGENT LOG

QC SET UP MENU

OPERATION SET UP

TURN ON VET PKG

TURN ON RETIC PKG

BAR CODE SET UP

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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 Operators 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.

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Revision Status
Document Control Number(s)
Original Issue (9140320A) 9140320B

Revision Date
12/98 3/99

Section(s) Revised
Not Applicable Chapter 10 Chapter 14

Pages Revised and Added


Not Applicable 10-75, 10-76, 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. All All All 1-6 through 1-9; 1-11; 1-17 through 1-24; 1-27 2-1; 2-3 through 2-5; 2-14 3-36 4-5 through 4-7; 4-11; 4-23 5-7; 5-9 and 5-10; 5-12; 5-50; 5-67; 5-88 through 5-91; 5-93 through 5-95; 5-98 through 5-102; 5-119; 5-121; 5-143 6-3; 6-26; 6-40 7-17; 7-25 All 9-3 and 9-4; 9-23 and 9-24; 9-27 through 9-54 10-32; 10-35 and 10-36; 10-58; 10-60; 10-68; 10-85 12-6 and 12-7; 12-11 13-44 and 13-45; 13-47; 13-52 14-1; 14-3; 14-69; 14-71 through 14-75, 14-77 and 14-78; 14-81 All New New
CELL-DYN 3700 System Operators Manual

9140320C 9140320D

11/00 6/03

All Master Table of Contents Foreword 1: System Description 2: Installation 3: Principles of Operation 4: System Specifications 5: Operating Instructions

6: Calibration 7: Quality Control 8: Hazards 9: Maintenance 10: Troubleshooting 12: Sample Loader 13: Veterinary Package 14: Reticulocyte

Appendix A Appendix B Index


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9140320E September 2004

Document Control Number(s)


9140320E

Revision Date
9/2004

Section(s) Revised
Master Table of Contents Foreword 1: System Description 2: Installation 3: Principles of Operation 4: System Specifications 5: Operating Instructions 6: Calibration All All

Pages Revised and Added

1-1; 1-6; 1-9; 1-24 through 1-27 2-1; 2-3; 2-5; 2-9; 2-12 and 2-13; 2-15 3-36 through 3-49; 3-55 and 3-56 4-6; 4-11; 4-17; 4-19 5-17 through 5-19; 5-50; 5-87 through 5-89; 5 103; 5-110; 5-123 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 7-15 through 7-19; 7-23; 7-26 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 10-23; 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 11-4; 11-6; 11-13 12-1 and 12-3 13-8 14-14; 14-32 through 14-34; 14-69; 14-71; 14-82 7 and 8 1 and 2; 4 New

7: Quality Control 9: Maintenance

10: Troubleshooting

11: Printers 12: Sample Loader 13: Veterinary Package 14: Reticulocyte Appendix A Appendix B Appendix C

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Document Control Number(s)


9140320F

Revision Date
4/2007

Section(s) Revised
Master Table of Contents List of Figures List of Tables Foreword 1: System Description 2: Installation 3: Principles of Operation 4: System Specifications 5: Operating Instructions 6: Calibration 7: Quality Control 9: Maintenance 10: Troubleshooting 11: Printers 13: Veterinary Package 14: Reticulocyte Bibliography Appendix B Index All All All

Pages Revised and Added

i through iv; vi and vii, x, xviii through xx 1-5; 1-19 through 1-21; 1-23 through 1-32 2-7 through 2-20 3-1 through 3-20; 3-36; 3-39; 3-43 through 3-64 4-15; 4-17; 4-20; 4-23; 4-25 5-88; 5-90 through 5-91; 5-143 6-5 and 6-6; 6-29; 6-35; 6-99 7-9; 7-16 through 7-17 9-54 10-61 All 13-8 14-7 and 14-8; 14-68; 14-69; 14-71; 14-77 and 14-78; 14-83 All B-4 All

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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 Control Number

Revision Date

Software Version

Revision Incorporated by

Date Incorporated

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NOTES

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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.

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System Description
Overview

Chapter 1

NOTES

1-2

CELL-DYN 3700 System Operators 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 LYM Lymphocyte absolute count MONO Monocyte absolute count EOS Eosinophil absolute count BASO Basophil absolute count %N Neutrophil percent %L Lymphocyte percent %M Monocyte percent %E Eosinophil percent %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 Operators Manual

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System Description
Intended Use

Chapter 1

NOTES

1-4

CELL-DYN 3700 System Operators 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).

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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 Viewing Window

Left Front Cover

Status Indicator Panel

Open Sample Aspiration Probe

Tube Retainer Closed Sample Aspiration Module Figure 1.3:

Touch Plate

CELL-DYN 3700CS System Analyzer Front View

1-6

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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.
CELL-DYN 3700 System Operators Manual

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9140320D June 2003

System Description
System Components

Chapter 1

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.

1-8

CELL-DYN 3700 System Operators Manual

9140320D June 2003

Chapter 1

Figure 1.4:
Grounding Wire Clip WOC Mixing Chamber A.C.C. Interlock Switch Grounding Wire Clip Sample Aspiration Peristaltic Pump Mounting Bracket WOC Flow Cell Cover Mounting Bracket Optical Bench Assembly

Mounting Bracket

Overflow Chamber

9140320E September 2004


Shear Valve Assembly Normally Closed Valves
.

CELL-DYN 3700 System Operators Manual

Aerosol Filter

von Behrens WIC Transducer Assembly

Analyzer Flow Panel Components


Waste Chamber 2 WOC Metering Syringe (contains Sheath Reagent) HGB/WIC Lyse Syringe (contains HGB/WIC Lyse) WOC Sheath Syringe (contains Sheath Reagent) HGB/WIC Diluent Syringe (contains Diluent)

WOC Transfer Peristaltic Pump

Wash Block

HGB Flow Cell

WIC Metering Assembly Open Sample Aspiration Probe

Mounting Bracket

von Behrens RBC/PLT Transducer Assembly

Waste Chamber 1

Touch Plate RBC/PLT Diluent Syringe (contains Diluent)

System Description

System Components

RBC/PLT Diluent Overpressure Sensor

Vacuum Accumulator Drain Line RBC/PLT Metering Assembly

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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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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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 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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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 Power Switch Sample Loader Connector Waste Sensor Port Diluent Inlet Tube Fitting Sheath Inlet Tube Fitting Detergent Inlet Tube Fitting WIC/HGB Lyse Inlet Tube Fitting Waste Outlet Tube Fitting Figure 1.5: Analyzer Serial Number Label Normally Closed Valves Solenoid Valves

Air Intake Filter

Diluent Reservoir Sheath Reservoir

Detergent Reservoir

Air Intake Filter

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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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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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 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 Operators Manual for detailed instructions.

PN 9230003E

Voltage Label, Rear Panel

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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 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:
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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 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 Serial Number Power Outlet Connector Monitor Video Cable Soft Key Interface Cable Com 2/ RS 232 Com 1/ External Computer Analyzer Port Monitor Video Cable Port Keyboard Data Station Port Soft Key Power Plug Interface Connector CPU Monitor Port Voltage Power (Touch Port) Selector Port Figure 1.9: Data Station Rear Components LPT 1 Graphics Printer Port

CPU Serial Number Label Fan

LPT 2 Ticket Printer Port

Monitor Serial Number Label


The Monitor Serial Number Label contains the manufacturers serial number for the Monitor.

CPU Serial Number Label


The CPU Serial Number Label contains the manufacturers serial number for the computer.

Soft Key Interface Cable (Touch Port)


The Soft Key Interface Cable transmits the Monitors Soft Key requests to the CPU for processing.

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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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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.

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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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 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 ELOs serial touch screen driver, AccuTouch (cable required). 3. PC In VGA video input 4. USB optional USB port for connecting ELOs 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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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 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 32F (0C) 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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A facsimile of the label that is on the reagent panel is shown below in Figure 1.12.
VORSICHT: Die Reagenzbeh lter nur ordnungsgem gesichert bewegen. ATTENTION : Ne pas manipuler le flacon de solution sans protection appropri e. PRECAUCI N: no maneje el recipiente de la soluci n a menos que est protegido adecuadamente. ATTENZIONE: Non maneggiare il recipiente della soluzione se non si protetti in modo adeguato. ATEN O: n o manipular o recipiente da solu o sem estar devidamente protegido. VIGTIGT: Beholderen med oplsning m ikke h ndteres, medmindre brugeren er korrekt beskyttet. VIKTIGT: Anv nd skyddskl der vid hantering av l sningsbeh llarna. : . UPOZORNN: Nemanipulujte s ndobou obsahujc roztok, pokud nen dn zabezpeena.

CAUTION: Do not handle Solution Container unless properly protected.

Consult instructions for use. / Gebrauchsanweisung beachten. / Consulter les instructions dutilisation. / Consulte las instrucciones de uso. / Consultare le istruzioni per luso. / Consultar as instru es de utiliza o. / Se brugsanvisningen. / L s tillh rande dokumentation. / . / Viz nvod k pouit.

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: RBC: PLT: HGB: 0.30 x 103/L (109/L) 0.03 x 106/L (1012/L) 10.0 x 103/L (109/L) 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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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/L (109/L).

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

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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 15-30C. 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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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.

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NOTES

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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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Overview

Chapter 2

NOTES

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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.

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Initial Preparation

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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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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 caps 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.

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Initial Preparation

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NOTES

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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.

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Monitor Serial Number Power Outlet Connector

Monitor Video Cable Soft Key Interface Cable Com 2/ RS 232 Com 1/ External Computer Analyzer Port Monitor Video Cable Port

CPU Serial Number Label Fan

Keyboard Data Station Port Power Plug Connector CPU Monitor Voltage Power Selector Port Figure 2.1:

Soft Key Interface Port (Touch Port)

LPT 2 Ticket Printer Port

LPT 1 Graphics Printer Port

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.
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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.

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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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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.

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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 threeprong 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 cables other end to the port labeled Auto Sampler on the Left Side Panel of the Analyzer. Secure the screws.

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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 110 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.

Bar Coded Position ID Label

Black End Rack Visual Indicator Label (END RACK ONLY) Rack ID Number Label

Tube Rack

Bar Coded Rack ID Label

Orient Numbered End DOWNWARD

Black End Rack Sensor Label (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.

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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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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.

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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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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 valves 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.

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Normally Closed Valves

Figure 2.5:

Front Flow Panel

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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 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.

3. Move the CELL-DYN 3700 System to the new location.

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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.

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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 Closed Mode (CS) Sample Loader (SL) 130 L 5% 240 L 5% 355 L 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.

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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 L for the WOC dilution 20 L for the WIC/HGB dilution 0.74 L 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-L 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 L 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-L 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 L 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-L 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 L 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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Sample Analysis Cycle Overview

Hemoglobin Analysis
1. After 200 L 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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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 instruments 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 77m aperture in the von Behrens WIC Transducer. The 200-L 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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WBC Analysis

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 L. 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.

Meniscus

Start Detector (Count Initiated)

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-L metered volume of the dilution is drawn through the 100-m 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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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

Sample Feed Nozzle

Sheath Stream

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 Laser Beam

Various Angles of Scattered Light 90 Scatter

0 Scatter

90D 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 90D, 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 (13, referred to as 0) and orthogonal light scatter (70110, referred to as 90) parameters. Two additional scatters, narrowangle light scatter (711, referred to as 10) and ninety-degree depolarized scatter (70110, referred to as 90D), 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 operators 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 Scatter PMT Front Surface Mirror Cylindrical Lens 700 m Slit Front Surface Mirror 125 m Vertical Slit Figure 3.4:

90 Depolarized Light Scatter PMT Polarizer (Horizontal)

Helium-Neon Laser (632.8 nm) Polarized Vertically Beam Splitter

10 Light Scatter Photodiode

Imaging Lens

0 Light Scatter WBC Photodiode Flow Obscuration Perforated Cell Bar Mirror

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-m slit which blocks the weaker outer edges. This process yields a uniformly intense beam approximately 80 m 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 L of the WOC dilution into the Sheath stream in the WOC Flow Cell. The sample is hydrodynamically focused into a small stream approximately 30 m 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-m 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 90D 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 operators 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 Separation

Mononuclear Polymorphonuclear Identification

90 Lobularity

10 Complexity

90 Lobularity

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 Separation

Neutrophil Eosinophil Identification

90 Depolarized Granularity

90 Lobularity Figure 3.6:

90 Depolarized Granularity

90 Lobularity Neutrophil-Eosinophil Scatter

Polymorphonuclear Separation
The scatter information is plotted with the 90D scatter on the Y axis and the 90 scatter on the X axis. (The 90D/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 90D light. The eosinophils scatter more 90D 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 Separation

Mononuclear Identification

0 Size

10 Complexity

0 Size

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. 90D/0 The scatter information is plotted with the 90D scatter on the Y axis and the 0 scatter on the X axis. 90D/10 The scatter information is plotted with the 90D 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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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 NEU LYM MONO EOS # x 103/L (109/L) # x 103/L (109/L) and % # x 103/L (109/L) and % # x 103/L (109/L) and % # x 103/L (109/L) and %

BASO # x 103/L (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. The granularity information (90D scatter) is plotted on the Y axis and the lobularity information (90 scatter) is plotted on the X axis.

GRANLRTY/LOBULARITY

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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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 70m aperture in the von Behrens RBC/PLT Transducer. Dynamic thresholding separates the PLTs from the RBCs. The 100-L 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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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.

Meniscus

Start Detector (Count 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 L. 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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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-L metered volume of the dilution is drawn through the 60 x 70m 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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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/L (1012/L) Counts below 1.0 x 106/L (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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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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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 13 fL region and the upper threshold floats in the 1535 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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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/L (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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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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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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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/L, 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/L (WOC) or 99.9 x 103/L (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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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 laboratorys 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 Elevated WBC count, increased numbers of giant PLTs, auto-agglutination, in vitro hemolysis Elevated WBC count, increased plasma substances (triglycerides, bilirubin, in vivo hemolysis), lytic-resistant RBCs. Elevated WBC count, hyperglycemia, in vitro hemolysis, increased numbers of giant PLTs.

RBC: HBG:

MCV:

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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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Parameter Flagging Messages


The following table summarizes all of the parameter flagging messages by parameter and category.
Table 3.1: Parameter Flagging Messages

Parameter WBC*

Dispersional Data Alerts Result displays in yellow if below lower limit Result displays in purple if 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

Suspect Parameter Flags WBC

Suspect Population Flags NWBC FWBC NRBC RRBC

Interpretive Messages Leukopenia Leukocytosis

Differential NEU LYM MONO EOS BASO RBC MCV RDW MCH MCHC

DFLT (NLMEB) Same as WBC

BAND IG BLAST VARLYM

Neutropenia Neutrophilia Lymphopenia Lymphocytosis Monocytosis Eosinophilia Basophilia Anemia Polycythemia Microcytic RBC Macrocytic RBC Hypochromic Hyperchromic Anisocytosis

RBC MORPH Same as WBC

PLT MPV

Same as WBC

LRI URI LURI PLTR

MPV Suppressed Thrombocytopenia (not displayed or Thrombocytosis printed) Microcytic PLT 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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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 instruments 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: Blank Ticket: Preprinted Ticket: Results outside limits underlined Results outside limits underlined Results outside limits marked with an asterisk (*)

Specimens with results that exceed the linearity should be diluted with Diluent according to the laboratorys 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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WIC and WOC Linearity


The WIC count is linear to 99.9 K/L. 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/L. 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 -----------Sequence #

FLAGGING DIAGNOSTICS Ready For Laboratory Use Only

Nov 19 1998 Operator ID Sequence # Open Sampler G R A N L R T Y

16:00 BLC 1471

BAND FLAG ESTIMATE REGION %: IG FLAG ESTIMATE REGION %: BLAST FLAG ESTIMATE REGION %: VAR LYM FLAG ESTIMATE REGION %: NRBC FLAG REGION ESTIMATE PER 100 WBCS:

MONO-POLY

LOBULARITY

9 0 d e g

9 0 d e g

10 deg PRINT

0 deg RETURN

Figure 3.13:

Flagging Diagnostics Screen

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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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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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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 (NonWBC) 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/L (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 instruments 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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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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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 laboratorys 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 There is a clinically significant difference between the WIC and WOC values and, therefore, the algorithm selected the WOC count as the most accurate WBC. Action Review a stained smear and follow your laboratorys protocol to confirm the WOC result.

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

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WBC Flag displayed next to the WBC result (Continued) Cause 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/L.) 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/L., the hemoglobin result is suppressed and displayed as <<<<. When the hemoglobin result is displayed as <<<<, MCH and MCHC results are not displayed. Action

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DFLT (NLMEB) displayed next to the BASO % Cause Default (preset) criteria were used to determine the five-part differential and therefore, some of the populations are suspect. 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, 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. Action Examine a stained smear to verify the differential values for the subpopulation(s) identified by the descriptor(s).

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PLT Flags
LRI (Lower Region Interference) displayed next to the MPV result Cause Interference in the lower threshold region (13 fL) is greater than a predetermined limit. This is generally non-biologic interference. The flag may be caused by: Debris (dirty aperture) Contaminated reagent Electronic noise Microbubbles URI (Upper Region Interference) displayed next to the MPV result Cause Interference in the upper threshold region (1535 fL) is greater than a predetermined limit. This is generally biologic interference. The flag may be caused by: Microcytic RBCs Schistocytes Giant Platelets Sickle Cells Platelet Clumps NOTE: A bumpy platelet histogram may indicate the presence of platelet clumps. Action Review the MCV and the PLT histogram. If the MCV is low and/ or the histogram indicates an overlap (poor separation at the upper discriminator) in the RBC and PLT populations, review a stained smear to determine the cause and verify the PLT count. Action Check the background count. If it exceeds the limits, troubleshoot accordingly. If it is within limits, repeat the specimen. If the flag persists, review a stained smear to determine the cause of the interference and verify the PLT count.

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

Suspect Population Flags


These flags are generated when the instruments 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 laboratorys 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 1. The count in the region of scatter (on the 0/10 plot) where bands are typically located is >12.5% of the total WBC 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 The count in the region of scatter (on the 0/10 plot) where immature granulocytes are typically located is >3% of the total WBC count. Action Review a stained smear for the presence of immature granulocytes and follow your laboratorys review criteria. When IGs are present, they are included in the total neutrophil count. Action Review a stained smear for the presence of bands and follow your laboratorys review criteria. When bands are present, they are included in the total neutrophil count.

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

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VAR LYM displayed next to the LYM % Cause 1. The count in the region of scatter on the size/complexity (0/10) scatterplot where variant Lymphs are typically located is >10% of the total WBC count. 2. The absolute lymphocyte or the 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. Action Review a stained smear for the presence of variant lymphocytes and/or smudge cells and follow your laboratory's review criteria. When variant lymphocytes or smudge cells are present, they are included in the lymphocyte count.

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

FWBC (Fragile White Blood Cells) displayed next to the Mono % result Causes The presence of fragile WBCs is suspected. A kinetic 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 selects WIC, estimated to be the best count for the reported WBC value, and displays the WBC flag to indicate that the result is suspect. Action Review a stained smear and follow your laboratory's review criteria to confirm the LYM values and the reported WBC value. If no suspect parameter flags are present, the confirmed WBC and Differential may be reported.

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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NRBC (Nucleated Red Blood Cells) displayed next to the MONO % Causes The presence of NRBCs is suspected. The WIC count is higher than the WOC and the WOC is the reported value. The count in the N1 region, below the dynamic WBC threshold on the size/complexity (0/10) scatterplot, is greater than 2.9% of the total WBC. Cell types that may be present in the N1 region: NRBCs PLT clumps Giant PLTs. Action Review a stained smear for the presence of NRBCs and follow your laboratory's review criteria. If NRBCs are present they should be quantified according to your laboratory's procedure. If correction of the WBC is required, correct the WIC value and use the resultant number to confirm the WOC result. If no other Suspect Parameter Flags are present, the corrected WIC (or confirmed 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 The presence of lyse-resistant RBCs is suspected. The WOC count is higher than the WIC count and there is a significant amount of stroma present (>2.9% of the total WBC) in the N1 region, below the dynamic WBC threshold on the size/ complexity (0/10) scatterplot. Action Repeat the specimen using the Resistant RBC cycle to eliminate interference from any lytic-resistant RBCs that may be present. (The Resistant RBC cycle reduces the number of flags generated. However, an increase in false positive band 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 laboratorys protocol.

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Flagging Summary

RBC Flag
RBC MORPH displayed next to the HCT result Cause One or more of the following parameters exceeds expected limits: MCV <80 fL or >100 fL MCH <25 pg or >34 pg MCHC <29 g/dL or >37 g/dL RDW >18.5% Action Review a stained smear for abnormal RBC or PLT morphology and follow your laboratorys review criteria.

PLT Flag
No MPV result displayed (data suppressed) Cause The PLT histogram did not meet expected criteria (non-log normal distribution). Action Review a stained smear for abnormal PLT morphology or the presence of PLT aggregates and follow your laboratorys 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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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 Leukopenia Leukocytosis Neutropenia Neutrophilia Lymphopenia Lymphocytosis Monocytosis Eosinophilia Basophilia Cause Result falls below the lower limit for WBC. Result exceeds the upper limit for WBC. Result falls below the lower limit for Neutrophil absolute number. Result exceeds the upper limit for Neutrophil absolute number. Result falls below the lower limit for Lymphocyte absolute number. Result exceeds the upper limit for Lymphocyte absolute number. Result exceeds the upper limit for Monocyte absolute number. Result exceeds the upper limit for Eosinophil absolute number. Result exceeds the upper limit for Basophil absolute number.

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Message Anemia Polycythemia Microcytic RBC Macrocytic RBC Hypochromic Hyperchromic Anisocytosis

Principles of Operation

Cause Result falls below the lower limit for RBCs. Result exceeds the upper limit for RBCs. Result falls below the lower limit for MCV. Result exceeds the upper limit for MCV. Result falls below the lower limit for MCHC. Result exceeds the upper limit for MCHC. Result exceeds the upper limit for RDW.

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

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NOTES

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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 1-56238-5275) 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898, 2004.

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Chapter 4
System Specification

System Specifications

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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NOTES

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CELL-DYN 3700SL System Specifications

CELL-DYN 3700SL System Specifications


Physical Specifications
Table 4.1: Dimensions

Analyzer with Sample Loader Height Width Depth Weight 27" (68 cm) 30" (76 cm) 31" (79 cm) 288 lb (131kg)

CPU 6.4 (16.3 cm) 16.9 (42.9 cm) 17.3 (43.9 cm) 32 lb (14.5 Kg)

Display Monitor 15 (38.1 cm) 14 (35.5 cm) 16 (40.6 cm) 30 lb (13.6 Kg)

Ticket Printer 6" (15 cm) 16.5" (41 cm) 14.5" (39 cm) 16.5 lb (7.5 kg)

Graphics Printer 13" (33 cm) 19" (48 cm) 24" (61 cm) 14.3 lb (6.5 kg)

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Power Specifications
Table 4.2: Power Specifications

Analyzer Input Requirements Setting 100 120 220 240 Range 90110 VAC 110130 VAC 200240 VAC 220260 VAC Data Station Input Requirements Setting 120 240 Range 90130 VAC 180260 VAC Printer Input Requirements (Graphics) Setting 120 VAC 240 VAC Frequency 50/60 Hz 50/60 Hz Frequency 50/60 Hz 50/60 Hz Frequency 50/60 Hz 50/60 Hz 50/60 Hz 50/60 Hz

Printer Input Requirements (Ticket) Setting 120 VAC Frequency 50/60 Hz

Sample Loader Input Requirements Setting 100 100 115 215 230 Range 90110 VAC 90110 VAC 105125 VAC 195235 VAC 210250 VAC Frequency 50 Hz 60 Hz 60 Hz 50 Hz 50 Hz

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CELL-DYN 3700SL System Specifications

Consumption
Analyzer: Data Station: Graphics Printer: Ticket Printer: Sample Loader: 900 watts 300 watts 110 watts 145 watts 50 watts

1550 watts maximum (5200 BTU per hour)

Transport and Storage Specifications


There are no specific environmental conditions for transport or storage.

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Operational Specifications
Operating Environment
Indoor Use Temperature Patient Samples: Room Temperature (1530C) Monocyte values exhibit a change at lower and higher temperatures. A 1.5% decrease is seen in the total monocyte percent at lower temperatures (<18C). A 6% increase will be seen at higher temperatures (>32C). Background values for RBC and PLT may exhibit an increase at lower environmental temperatures (<18C). Instrument: 1530C Relative Humidity 10% to 85%, RHNC

Complete Cycle Times


Auto-Startup (from Standby) Auto-Startup (from power OFF) Run, Open Mode Run, Sample Loader Shutdown (to Standby) Approximately 3.5 minutes Approximately 5 minutes* 37 seconds (READY to READY) Approximately 37 seconds 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 Sample Loader 130 L (Auxiliary Specimen Type 300 L) 355 L

Batch Size
1100 tubes per batch

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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.
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CELL-DYN 3700CS System Specifications

CELL-DYN 3700CS System Specifications


Physical Specifications
Table 4.3: Dimensions

Analyzer Height Width Depth Weight 24" (61 cm) 30" (76 cm) 22" (56 cm) 190 lb (86 kg)

CPU 6.4 (16.3 cm) 16.9 (42.9 cm) 17.3 (43.9 cm) 32 lb (14.5 Kg)

Display Monitor 15 (38.1 cm) 14 (35.5 cm) 16 (40.6 cm) 30 lb (13.6 Kg)

Ticket Printer 6" (15 cm) 16.5" (41 cm) 14.5" (39 cm) 16.5 lb (7.5 kg)

Graphics Printer 13" (33 cm) 19" (48 cm) 24" (61 cm) 14.3 lb (6.5 kg)

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Power Specifications
Table 4.4: Power Specifications

Analyzer Input Requirements Setting 100 120 220 240 Range 90110 VAC 110130 VAC 200240 VAC 220260 VAC Data Station Input Requirements Setting 120 240 Range 90130 VAC 180260 VAC Printer Input Requirements (Graphics) Setting 120 VAC 240 VAC Frequency 50/60 Hz 50/60 Hz Frequency 50/60 Hz 50/60 Hz Frequency 50/60 Hz 50/60 Hz 50/60 Hz 50/60 Hz

Printer Input Requirements (Ticket) Setting 120 VAC Frequency 50/60 Hz

Consumption
Analyzer: Data Station: Graphics Printer: Ticket Printer: 900 watts 300 watts 110 watts 145 watts

1550 watts maximum (5200 BTU per hour)

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CELL-DYN 3700CS System Specifications

Operational Specifications
Operating Environment
Temperature Patient Samples: Room Temperature (1530C) Monocyte values exhibit a change at lower and higher temperatures. A 1.5% decrease is seen in the total monocyte percent at lower temperatures (<18C). A 6% increase will be seen at higher temperatures (>32C). Instrument: 1530C Background values for RBC and PLT may exhibit an increase at lower environmental temperatures (<18C). Relative Humidity 10% to 85%, RHNC

Complete Cycle Times


Auto-Startup (from Standby) Auto-Startup (from power OFF) Run, Open Mode Run, Closed Mode Shutdown (to Standby) Approximately 3.5 minutes Approximately 5 minutes* 37 seconds (READY to READY) Approximately 40 seconds 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 Closed Mode 130 L (Auxiliary Specimen Type 300 L) 240 L

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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 Aperture Size Dilution Electrical Impedance 100 m (diameter) x 77 m (length) 1:301 of blood in Diluent and WIC/HGB Lyse 256 channels, each channel = 0.5 fL

Data Collection

WOC:

Method Light Source

Laser light scatter Vertically polarized 510 mW heliumneon laser 632.8 nm 1:51 of blood in Sheath Reagent Four angles measured: 0, 10, 90, and 90 depolarized. Data collected in 256 channels for each angle of light scatter.

Wavelength Dilution Data Collection

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Chapter 4

RBCs and PLTs


Method Aperture Size Dilution Data Collection Electrical Impedance 60 m (diameter) x 72 m (length) 1:9,760 of blood in Diluent 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 Emitting Diode, wavelength: 555 nm Interference Filter Center wavelength: 540 nm Bandwidth (at 1/2 peak): 22 nm 1:301 of blood in Diluent and WIC/HGB Lyse or WIC/HGB Cyanide-Free Lyse Average of 5 absorbance readings for the detergent blank, average of 5 absorbance readings for the sample dilution

Light Source Filter

Dilution

Data Collection

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Combined Specifications for the SL and CS Systems

Performance Specifications
Background Counts (Acceptable Up to Limits Listed)
WIC WOC RBC HGB PLT RETIC <0.30 <0.30 <0.03 <0.20 <10.0 <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.

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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 WBC (WOC) WBC (WIC) RBC HGB MCV RDW PLT MPV RETIC %

CV <2.5% <2.8% <1.5% <1.2% <1.0% <5.0% <5.0% <6.1% <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 samples WBC subpopulations should fall within the ranges listed below.
Table 4.6: Precision of the WBC Differential Parameters

Cell Type Neutrophil % Lymphocyte % Monocyte % Eosinophil % Basophil %

Range 4570% 20 40% 3.511.5% 0.5 8.0% 0.52.0%

Difference from Mean of N = 31 2.1 2.6 2.4 1.0 1.0

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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

Parameter WBC

Linear Range 099.9 K/L 0250 K/L 08 M/L 024 g/dL 50200 fL 02000 K/L 518 fL 030 %

Acceptable Limits (whichever is greater) +0.4 or 3.0% +0.4 or 4.0% +0.1 or 2.5% +0.3 or 2.0% +3.0 or 3.0% +10.0 or 7% +1.0 or 6.0% +1.1 or 7.0%

WIC WOC

RBC HGB MCV PLT MPV RETIC %

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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 WBC RBC HGB MCV PLT MPV RETIC %

Correlation Coefficient >0.99 >0.98 >0.98 >0.98 >0.98 >0.92 >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 lownormal threshold levels.

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WBC Differential Parameters


Table 4.9: Accuracy of WBC Differential Parameters

Parameter Neutrophil # and % Lymphocyte # and % Monocyte # and % Eosinophil # and % Basophil # and %

Correlation Coefficient >0.95 >0.94 >0.86 >0.84 >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: % Carryover = Background1 Background3 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 Level 90K/L

RBC 7.5M/L

HGB 22.5g/dl

PLT 1000 K/L

RETIC % 30,000 list mode counts <0.5%

Carryover <1.0% or <1.0% or <1.0% or <1.0% or (in % or <0.1 K/L <0.03 M/L <0.1 g/dL <10 K/L Absolute)

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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 WBC RBC HGB MCV RDW PLT MPV

Typical CV 1.9% 1.0% 0.7% 0.8% 3.2% 3.1% 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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Table 4.12:

Reference Range for Distributional Flagging

Parameter Neutrophil % Lymphocyte % Monocyte % Eosinophil % Basophil %


Table 4.13:

Reference Range 46.5%88.7% 12.0%44.0% 011.2% 09.5% 02.5%

Reference Range for Morphologic Flagging

Parameter Variant Lymphocytes Bands Immature Granulocytes* Blasts NRBCs

Reference Range 03% 012% 01% 01% 01/100 WBCs

* Immature granulocytes include metamyelocytes, myelocytes, and promyelocytes.

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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 Granulocytosis Granulocytopenia Lymphocytosis Lymphocytopenia Monocytosis Eosinophilia Basophilia Bands >12% Metamyelocytes >1% Myelocytes >1% Promyelocytes >1% Blasts >1% Variant Lymphocytes >3% NRBCs >1/100 WBCs

Number of Cases 40 27 21 106 31 4 4 28 32 13 10 12 22 5

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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 = FN =
Table 4.15: Flagging Analysis Truth Table

False Positive False Negative

CELL-DYN 3700 Normal Reference Normal Reference Morphological Positive Reference Distributional Positive Total 165 TN 2 FN 1 FN 168

CELL-DYN 3700 Morphological Positive 35 FP 46 TP 38 TP 119 82.9% 27.0% 2.0%

CELL-DYN 3700 Distributional Positive 26 FP 9 TP 52 TP 87

Total 226 57 91 374

Agreement = False Positives = False Negatives =

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 Morphological False Negative Distributional False Negative 2% Metamyelocytes 4% Metamyelocytes 6.3% Lymphocytes

CELL-DYN 3700 Differential No Flag generated No Flag generated 12.0% Lymphocytes

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NOTES

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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.

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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 laboratorys 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.

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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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Overview

Main Menu Screen

Version X.XX

CD 3700SL MAIN MENU Ready

Dec 05 1998 Operator ID Sequence #

15:50 sh 0067

SET UP

RUN

DATA LOG

RETIC DATA LOG

QUALITY CONTROL

CALIBRATION

DIAGNOSTICS

SPECIAL 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.

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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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Overview

Conventions Used in This Manual


The following conventions are used in this manual: Information Note, Caution, Warning Bulletin message, status, or other screen display Data entry field Menu names Soft key names References to other text Presentation ALL CAPS, BOLDFACE MONOSPACE FONT, BOLDFACE <Sans Serif Font, Angle Brackets> SANS SERIF FONT, ALL CAPS [SANS SERIF FONT, ALL CAPS, BRACKETS] Bold: Bold & Italics Examples NOTE: Ready <Date/Time> SET UP [SET UP] 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 DATA LOG

QUALITY CONTROL

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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 DATA LOG

QUALITY CONTROL

CALIBRATION

DIAGNOSTICS

SPECIAL PROTOCOLS

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Operating Instructions Chapter 5 Set Up Menu Flowchart


SET UP MENU Ready

Overview

DATE/ TIME

PATIENT LIMITS

REAGENT LOG

CUSTOMIZE QC SET UP OPERATION UNITS SELECTION REPORT MENU SET UP

MAIN

LIMIT SET 1

LIMIT SET 2

LIMIT SET 3

LIMIT SET 4

PRINT

RETURN

TURN ON VET PKG RETURN TURN OFF VET PKG

TURN ON RETIC PKG TURN OFF RETIC PKG

BAR CODE SET UP TOGGLE ON/OFF

COMPUTER SET UP SETUP

RETURN (to MAIN)

DELETE ENTRY

DILUENT LOG

WIC/HGB LYSE LOG

SHEATH LOG

DETERGENT LOG

PRINT LOG

X-B SET UP

LAB ID SET UP

QC LIMITS

SET UP QC FILE

CUSTOMIZE CUSTOMIZE PRINTOUT DISPLAY

MAIN

REINIT STOP INTERFACE TRANSMISS

TOGGLE ON/OFF

SET UP

TURN X-B TURN X-B RBC ON WBC ON TURN X-B TURN X-B RBC OFF WBC OFF

PRINT

RETURN USA UNITS SI UNITS

CONFIRM STOP SI MOD UNITS SET 1 UNITS

CANCEL STOP SET 2 UNITS SELECT UNITS RETURN

RANGE ENTRY MEANS/ LIMITS

LOAD UPDATE FROM FILE FROM DISK

PRINT

RETURN

SELECT CANCEL STANDARD PARAMETER SELECTION SELECTION PLACE PARAMETER

TOGGLE ONE/ALL

RETURN

LOAD LOW

LOAD NORMAL

LOAD HIGH

RETURN SELECT PARAMETER CANCEL SELECTION STANDARD GROUPS CUSTOM PLACEMENT TOGGLE ONE/ALL RETURN

CONFIRM UPDATE

CANCEL UPDATE

LOT NUMBER REPLICATE ID

TOGGLE ON/OFF

PRINT

RETURN

PLACE PARAMETER

WBC GROUP

RBC GROUP

PLT GROUP

DIFF GROUP

LATEX SET

CUSTOMIZE RETURN PRINTOUT

CUSTOMIZE DISPLAYED REPORT Ready

PARAM SET 1

PARAM SET 2

PARAM SET 3

PARAM SET 4

CUSTOMIZE CUSTOMIZE PRINTOUT HEADER

SELECT GRAPH

SET UP

PARAM SET 1 CUSTOMIZE PRINTED REPORT Ready

PARAM SET 2

PARAM SET 3

PARAM SET 4

CUSTOMIZE CANCEL PRINTOUT GRAPH

PLACE GRAPH

SET UP

CUSTOMIZE PRINTOUT HEADER Ready

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

SET UP

RESTORE HEADER

BLANK CUSTOMIZE CUSTOMIZE HEADER DISPLAY PRINTOUT

SET UP

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Chapter 5

Run Menu Flowchart


RUN Ready

CLEAR APERTURES CLEAR FAULT PRIME

WORK LIST

SPECIMEN CUSTOMIZE CHANGE TYPE REPORT SAMPLER see CUSTOMIZE REPORT of SET UP MENU

PRINT TICKET

PRINT REPORT COLOR PRINT

MAIN

PATIENT

QC SPECIMEN

BACKGROUND

ELECTRICL BACKGRND

LATEX

RESISTANT RBC

AUXILIARY

RETURN

WORK LIST BAR CODE ON ON WORK LIST BAR CODE OFF OFF

INSERT/ DELETE

DELETE ALL

PURGE WORK LIST COMPLETED SET UP

PRINT WORK LIST

RETURN

CONFIRM DELETION

CANCEL DELETION

TOGGLE ON/OFF

RETURN

INSERT

DELETE

RETURN

CONFIRM PURGE

CANCEL PURGE

Data Log Menu Flowchart


DATA LOG Ready

EDIT ID

PRINT FIND REJECT CUSTOMIZE TRANSMIT DISPLAY DATA LOG SPECIMEN SPECIMEN FROM X-B DATA LOG DATA ACCEPT INTO X-B SELECT STANDARD CUSTOMIZE PARAMETER GROUPS PRINTOUT

MAIN

RETURN

PLACE CANCEL PARAMETER SELECTION

RETURN

SELECT STANDARD PARAMETER GROUPS

RETURN

PLACE CANCEL PARAMETER SELECTION

RETURN

WBC GROUP

RBC GROUP

PLT GROUP

DIFF GROUP

CUSTOM CUSTOMIZE RETURN PLACEMENT PRINTOUT

EDIT PREVIOUS NEXT CUSTOMIZE TRANSMIT SPECIMEN SPECIMEN SPECIMEN REPORT SPECIMEN

PRINT TICKET

PRINT REPORT COLOR PRINT

RETURN

CONFIRM

CANCEL

see CUSTOMIZE REPORT of SET UP MENU

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Overview

Quality Control Menu Flowchart

QC MENU Ready

X-B SET UP

X-B FILE

VIEW QC LOG

QC LIMITS

SET UP QC FILE

CUSTOMIZE CUSTOMIZE PRINTOUT DISPLAY

MAIN

TURN ON TURN ON X-B WBC X-B RBC TURN OFF TURN OFF X-B WBC X-B RBC

PRINT

RETURN SELECT CANCEL STANDARD PARAMETER SELECTION SELECTION PLACE PARAMETER TOGGLE ONE/ALL RETURN

X-B RBC GRAPHS X-B RBC DATA

X-B WBC GRAPHS X-B WBC DATA

PRINT

RETURN

SELECT PARAMETER PLACE PARAMETER WBC GROUP LOT NUMBER REPLICATE ID RANGE ENTRY

CANCEL SELECTION

STANDARD GROUPS CUSTOM PLACEMENT

TOGGLE ONE/ALL

RETURN

RBC GROUP

PLT GROUP

DIFF GROUP

LATEX SET

CUSTOMIZE RETURN PRINTOUT

TOGGLE ON/OFF

PRINT

RETURN

UPDATE FROM FILE

LOAD FROM DISK

PRINT

RETURN

MEANS/ LIMITS WRITE QC TO DISK LOAD LOW LOAD NORMAL LOAD HIGH RETURN

PURGE QC LOG

LEVEYJENNINGS

REJECT SPECIMEN ACCEPT SPECIMEN

DELETE SPECIMEN

MOVE SPECIMEN

PRINT QC LOG

RETURN

CONFIRM PURGE

CANCEL PURGE

CONFIRM UPDATE CONFIRM CANCEL DELETION DELETION MOVE TO FILE CANCEL MOVE

CANCEL UPDATE

GROUP 1

GROUP 2

GROUP 3

GROUP 4

PRINT

RETURN

WRITE LOW

WRITE NORMAL

WRITE HIGH

RETURN

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Chapter 5

Calibration Menu Flowchart


CALIBRATION Ready

ENTER FACTOR

CALIBRATN LOG

AUTOCALIBRATE

CLOSED SAMPLER OPEN SAMPLER

PRINT

MAIN

RESTORE FACTORS

RESET ALL TO 1.000

RETURN WHOLE BLOOD CALIBRATR MPV LATEX CHANGE SAMPLER (CS MODEL ONLY) RETURN

CLOSED SAMPLER OPEN SAMPLER

PRINT LOG

RETURN

EDIT REF VAL

START AUTO-CAL

CONTINUE AUTO-CAL

QUIT AUTO-CAL

CLEAR REF VALS

PRINT SUMMARY

RETURN

CONFIRM QUIT CONFIRM QUIT PRINT SUMMARY

PRINT SUMMARY CANCEL QUIT

CANCEL QUIT

EDIT REF VAL

START AUTO-CAL

CONTINUE QUIT AUTO-CAL AUTO-CAL

CLEAR REF VALS

PRINT SUMMARY

RETURN

PREVIOUS SPECIMEN

NEXT SPECIMEN

REPEAT SPECIMEN

INTERRUPT QUIT AUTO-CAL AUTO-CAL CONTINUE AUTO-CAL

ACCEPT MEANS

PRINT

RETURN

CONFIRM REPEAT

CANCEL REPEAT CONFIRM QUIT

CONFIRM ACCEPT CANCEL QUIT

CANCEL ACCEPT

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Overview

Diagnostics Menu Flowchart


DIAGNOSTICS MENU Ready

FAULT REPORT

EXECUTION TIMES

CNT RATE SUMMARY

CLEAR FAULTS

RAW DATA SUMMARY

MORE

PRINT

MAIN

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

PRINT

RETURN

MOTOR SOLENOID OPERATION OPERATION

PUMP DRAIN OPERATION ACCUMULAT

INITIALIZATION

MORE

MAIN

CYCLE BANK

STEP SOLENOID

DIAGNOSTICS

DIGITAL READINGS

VOLTAGE READINGS

GAIN ADJUSTMNT

MORE

PRINT

MAIN

VACUUM PRESSURE INHIBIT ON ON PUMPS VACUUM PRESSURE ENABLE OFF OFF PUMPS

VACUUM TEST

PRESSURE TEST

DIAGNOSTICS

MOTOR PWR CHECKING

HOME MOTORS

EXERCISE MOTOR

SHEAR VAL SHEAR VAL PRINT TIME DISPENSE SHEAR VAL ASPIRATE

DIAGNOSTICS

FINISH SELECT

SELECT

DIGITAL READINGS

VOLTAGE READINGS

GAIN ADJUSTMNT

MORE

PRINT

MAIN

VERIFY GAINS

ENTER SETTINGS

AUTO GAIN ADJUSTMNT

CURRENT SETTINGS

SIGNAL GENERATOR

PRINT

DIAGNOSTICS

MAM TESTING

SPM TESTING

WIM TESTING

PRINT

RETURN

WOC DATA

RBC PLT WIC MORE DATA DATA DATA RBC PLT WIC HISTOGRAM HISTOGRAM HISTOGRAM

PRINT

MAIN

AUTO-SAMP BAR CODE BAR CODE VERSION ALIGNMENT VERIFY

SERIAL TEST

MORE

PRINT

MAIN

WOC 1 WOC 2 DATA DATA WOC 1 WOC 2 HISTOGRAM HISTOGRAM

CALC CV

SCATTER GRAPHS

SMOOTHING EXTENDED ON/OFF WOC COUNT

PRINT

DIAGNOSTICS

STOP TRANSMISS

TRANSMIT MESSAGE

DIAGNOSTICS

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Special Protocols Menu Flowchart

SPECIAL PROTOCOLS Ready

EMPTY REAGENT XDUCERS RESERVOIR FILL XDUCERS

EMPTY WOC FILL WOC

MAINTEN LOG

CLEAN DISABLE SHEAR VAL ANALYZER ENABLE RESTORE SHEAR VAL ANALYZER

MORE

MAIN

EMPTY DILUENT FILL DILUENT

EMPTY LYSE FILL LYSE

EMPTY EMPTY RETURN SHEATH DETERGENT FILL FILL SHEATH DETERGENT

INTERVAL SET UP

UPDATE LOG

PRINT & PURGE

PRINT LOG

RETURN

PRINT

RETURN

FLUSH SHEATH

AUTO CLEAN

DAILY SHUTDOWN

PREPARE SHIPPING

CLEAN NEEDLE

EXTEND AUTOCLEAN

MORE

MAIN

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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 laboratorys requirements. The function of each soft key is discussed on the following pages, and setup procedures are included where applicable.

SET UP MENU Ready

Dec 15 1998 Operator ID Sequence #

15:51 wam 0067

DATE/ TIME

PATIENT LIMITS

REAGENT LOG

QC SET UP MENU

OPERATION SET UP

UNITS SELECTION

CUSTOMIZE REPORT

MAIN

Figure 5.3:
SET UP

Set Up Menu Screen

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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Date/Time Soft Key


DATE/TIME SET UP Ready Dec 15 1998 Operator ID Sequence # 15:52 rls 0067

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

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

2 3

Date (Month/Day/Year): --/--/-Time (00:00 to 23:59): --:--

RETURN

Figure 5.4:
DATE/ TIME

Date/Time Set Up Screen

The [DATE/TIME] key on the SET UP MENU is used to display the 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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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.

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Patient Limits Soft Key


LIMIT SET 1 Ready Lower Limits WBC NEU LYM MONO EOS BASO RBC HGB HCT MCV MCH MCHC RDW PLT MPV PCT PDW LIMIT SET 2 4.6 2.0 0.6 0.0 0.0 0.0 4.04 12.2 37.7 80.0 27.0 31.8 11.6 142. 0.0 0.00 0.0 K/uL K/uL K/uL K/uL K/uL K/uL M/uL g/dL % fL pg g/dL % K/uL fL % 10(GSD) LIMIT SET 3 37.0 10.0 0.0 0.0 0.0 %N %L %M %E %B 10.2 6.9 3.4 0.9 0.7 0.2 6.13 18.1 53.7 97.0 31.2 35.4 14.8 424. 99.9 9.99 99.9 Dec 15 1998 Operator ID Sequence # Upper Limits K/uL K/uL K/uL K/uL K/uL K/uL M/uL g/dL % fL pg g/dL % K/uL fL % 10(GSD) 80.0 50.0 12.0 7.0 2.5 %N %L %M %E %B 11:15 732 6799

LIMIT SET 4

PRINT

RETURN

Figure 5.5:
PATIENT LIMITS

Patient Limit Set Screen

The [PATIENT LIMITS] key on the SET UP MENU is used to display one 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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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 Leukocytosis Neutropenia Neutrophilia
CELL-DYN 3700 System Operators Manual

Result falls below the lower limit for WBC. Result exceeds the upper limit for WBC. Result falls below the lower limit for neutrophil absolute number. Result exceeds the upper limit for neutrophil absolute number.
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Set Up Instructions Lymphopenia Lymphocytosis Monocytosis Eosinophilia Basophilia

Chapter 5
Result falls below the lower limit for lymphocyte absolute number. Result exceeds the upper limit for lymphocyte absolute number. Result exceeds the upper limit for monocyte absolute number. Result exceeds the upper limit for eosinophil absolute number. Result exceeds the upper limit for basophil absolute number.

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

PLT Messages
Thrombocytopenia Thrombocytosis Microcytic PLT Macrocytic PLT Result falls below the lower limit for PLTs. Result exceeds the upper limit for PLTs. Result falls below the lower limit for MPV. 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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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 25 to enter the desired limits. 7. Press the [RETURN] key to return to the SET UP MENU screen.

Reagent Log Soft Key


DILUENT LOG Ready Dec 15 1998 Operator ID Sequence # 16:30 sh 0630

List Number -----------

Lot Number 013511 013511 -----------------------------------------------------------------

Expiration Date 02/28/20 02/28/20 --/--/---/--/---/--/---/--/---/--/---/--/---/--/---/--/--

Open Date 12/02/98 12/17/98 --/--/---/--/---/--/---/--/---/--/---/--/---/--/---/--/--

DELETE ENTRY

WIC/HGB LYSE LOG

SHEATH LOG

DETERGENT LOG

PRINT LOG

MAIN

Figure 5.6:
REAGENT LOG

Diluent Log Screen

The [REAGENT LOG] key is used to display one of the reagent logs. (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.

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Each reagent log can hold 10 entries. The following information may be entered for each reagent: List Number Expiration Date Lot Number 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 35 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 27 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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Set Up Instructions

QC Set Up Menu Soft Key


QC SET UP MENU Ready Dec 15 1998 Operator ID Sequence # 15:57 ebb 0067

File Name 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. FILE 1 FILE 2 FILE 3 FILE 4 FILE 5 FILE 6 FILE 7 FILE 8 FILE 9 FILE 10

# Specimens 0 0 0 0 0 0 0 0 0 0 11. 12. 13. 14. 15. 16. 17. 18. 19. 20.

File Name FILE 11 FILE 12 FILE 13 FILE 14 FILE 15 FILE 16 FILE 17 FILE 18 FILE 19 FILE 20

# Specimens 0 0 0 0 0 0 0 0 0 0

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

X-B SET UP

LAB ID SET UP

QC LIMITS

SET UP QC FILE

CUSTOMIZE DISPLAY

CUSTOMIZE PRINTOUT

RETURN

Figure 5.7:
QC SET UP MENU

QC Set Up Menu Screen

The [QC SET UP MENU] key is used to display a list of the QC files (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.

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Set Up QC File Soft Key

QC FILE SET UP Ready FOR Low

Nov 20 1998 Operator ID Sequence #

15:33 sh 0630

Lot Number:

12345 12/30/98

2 3

Expiration Date (Month/Day/Year): WESTGARD RULE SELECTION: ON ON ON ON ON ON 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. REPLICATE ID TOGGLE ON/OFF PRINT RETURN

Figure 5.8:

QC File Set Up (Lot Number Entry) Screen

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QC FILE SET UP Ready FOR Low

Nov 20 1998 Operator ID Sequence #

13:33 sh 0630

1 3
WESTGARD RULE SELECTION: ON ON ON ON ON ON

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

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.

LOT NUMBER

TOGGLE ON/OFF

PRINT

RETURN

Figure 5.9:
SET UP QC FILE

QC File Set Up (Replicate ID Entry) Screen

The [SET UP QC FILE] key is used to configure the selected 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.) (This key label is present only when the cursor is in one of the Westgard Rule Selection fields.)

TOGGLE ON/OFF

PRINT RETURN

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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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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 SET UP

The [LAB ID SET UP] key enables the entry of QC limits into a QC 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 LIMITS

The [QC LIMITS] key is used to display the QC MEANS/LIMITS ENTRY 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 Set Up Instructions The [RANGE ENTRY] key is used to enter the upper and lower flagging limits as absolute numbers (see the following figure). 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).

Means and Limits

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 Ready FOR LOW Lower Limits WOC WIC WBC NEU %N LYM %L MONO %M EOS %E BASO 2.0 2.0 2.0 1.1 66.5 0.0 7.6 0.0 3.4 0.0 0.0 0.0 K/uL K/uL K/uL K/uL %N K/uL %L K/uL %M K/uL %E K/uL Upper Limits 2.6 2.6 2.6 2.3 80.5 0.9 21.6 0.4 13.4 0.1 5.0 0.5 K/uL K/uL K/uL K/uL %N K/uL %L K/uL %M K/uL %E K/uL %B RBC HGB HCT MCV MCH MCHC RDW PLT MPV PCT PDW

Nov 21 1998 Operator ID Sequence # Lower Limits 0.0 2.33 6.6 18.5 78.8 25.8 31.4 13.8 43. 9.4 0.05 14.8 %B M/uL g/dL % fL pg g/dL % K/uL fL % 10(GSD)

16:24 757 9110 Upper Limits 6.5 2.63 7.2 21.5 82.8 29.8 37.4 17.8 61. 11.4 0.07 16.2 %B M/uL g/dL % fL pg g/dL % K/uL fL % 10(GSD)

MEANS/ LIMITS

UPDATE FROM FILE

LOAD FROM DISK

PRINT

RETURN

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 Ready FOR CONTROL H

Dec 18 1998 Operator ID Sequence #

11:35 C03 4300

Means WOC WIC WBC NEU %N LYM %L MONO %M EOS %E BASO 50.0 50.0 50.0 50.0 50.0 50.0 50.0 50.0 50.0 50.0 50.0 50.0 K/uL K/uL K/uL K/uL %N K/uL %L K/uL %M K/uL %E K/uL

Limits(+/-) 50.0 50.0 50.0 50.0 50.0 50.0 50.0 50.0 50.0 50.0 50.0 50.0 K/uL K/uL K/uL K/uL %N K/uL %L K/uL %M K/uL %E K/uL %B RBC HGB HCT MCV MCH MCHC RDW PLT MPV PCT PDW

Means 5.00 50.0 50.0 500. 50.0 50.0 50.0 500. 50.0 5.00 50.0 50.0 %B M/uL g/dL % fL pg g/dL % K/uL fL % 10(GSD)

Limits(+/-) 5.00 50.0 50.0 500. 50.0 50.0 50.0 500. 50.0 5.00 50.0 50.0 %B M/uL g/dL % fL pg g/dL % K/uL fL % 10(GSD)

RANGE ENTRY

UPDATE FROM FILE

LOAD FROM DISK

PRINT

RETURN

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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QC MEANS/LIMITS ENTRY Ready FOR Normal

Dec 21 1998 Operator ID Sequence #

16:24 sh 0630

Means WIC WOC WBC NEU %N LYM %L MONO %M EOS %E BASO 7.5 7.5 7.5 4.8 64.0 1.5 20.8 0.8 10.7 0.2 2.7 0.2 K/uL K/uL K/uL K/uL %N K/uL %L K/uL %M K/uL %E K/uL

Limits(+/-) 0.6 0.6 0.6 1.5 7.0 0.8 10.0 0.5 3.5 0.2 1.5 0.2 K/uL K/uL K/uL K/uL %N K/uL %L K/uL %M K/uL %E K/uL %B RBC HGB HCT MCV MCH MCHC RDW PLT MPV PCT PDW

Means 2.7 4.21 12.5 39.1 92.9 29.7 32.0 15.6 229. 10.3 5.00 50.0 %B M/uL g/dL % fL pg g/dL % K/uL fL % 10(GSD)

Limits(+/-) 2.7 0.18 0.4 2.4 3.0 2.0 3.0 2.2 25. 1.0 4.99 50.0 %B M/uL g/dL % fL pg g/dL % K/uL fL % 10(GSD)

RANGE ENTRY

UPDATE FROM FILE

LOAD FROM DISK

PRINT

RETURN

Figure 5.12:

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

UPDATE FROM FILE

The [UPDATE FROM FILE] key is displayed on the 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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Set Up Instructions 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: NEU, LYM, and MONO: Remaining Parameters: 10% of the computed mean 40% of the computed mean 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 Ready FOR FILE 1 Customize QC display for all QC files Group 1: Group 2: Group 3: Group 4: WBC RBC PLT WBC NEU HGB MPV %N LYM HCT PCT %L MONO EOS MCV PDW %M %E %B MCH BASO MCHC RDW

Dec 21 1998 Operator ID Sequence #

16:23 0067

WBC RBC PLT RUT1 WUT SELECT PARAMETER

NEU HGB MPV %N RUT2 WCT

LYM HCT PCT %L RCT1 WIC

MONO MCV PDW %M RCT2 WOC

EOS MCH %E EMPTY

BASO MCHC RDW %B

STANDARD GROUPS

TOGGLE ONE/ALL

RETURN

Figure 5.13:

Customize QC Display Screen

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CUSTOMIZE DISPLAY

Set Up Instructions The [CUSTOMIZE DISPLAY] key is used to display the 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 is the RBC/PLT Count Time. RCT2 is the RBC/PLT Count Time for an extended count. WUT is the WIC Upper Metering Time. WCT is the WIC Count Time. WIC is the WBC Impedance Count. WOC is the WBC Optical Count. EMPTY inserts an empty column in the display.

RCT1 and RCT2

WUT WCT WIC WOC EMPTY


SELECT PARAMETER

The [SELECT PARAMETER] key is used to select parameters and place them in the desired location. The [STANDARD GROUPS] key is used to select a predetermined 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.

STANDARD GROUPS

TOGGLE ONE/ALL

The [TOGGLE ONE/ALL] key is used to customize one file only or 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 46 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 Ready FOR FILE 1 Customize QC display for the current file Group 1: Group 2: Group 3: Group 4: WBC RBC PLT WBC NEU HGB MPV %N LYM HCT PCT %L MONO EOS MCV PDW %M %E %B MCH BASO MCHC RDW

Dec 21 1998 Operator ID Sequence #

16:23 0067

WBC RBC PLT RUT1 WUT

NEU HGB MPV %N RUT2 WCT

LYM HCT PCT %L RCT1 WIC

MONO MCV PDW %M RCT2 WOC

EOS MCH %E EMPTY

BASO MCHC RDW %B

WBC GROUP

RBC GROUP

PLT GROUP

DIFF GROUP

LATEX SET

CUSTOM PLACEMENT

TOGGLE ONE/ALL

RETURN

Figure 5.14:
STANDARD GROUPS

Customize QC Display Screen Showing Standard Groups

Predetermined groups of parameters, called Standard 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 (14). 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 SET

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

TOGGLE ONE/ALL

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Customize Printout Soft Key

CUSTOMIZE QC PRINTOUT Ready FOR Normal

Dec 21 1998 Operator ID Sequence #

16:23 sh 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 RBC PLT RUT1 WUT

NEU HGB MPV %N RUT2 WCT

LYM HCT PCT %L RCT1 WIC

MONO MCV PDW %M RCT2 WOC

EOS MCH %E EMPTY

BASO MCHC RDW %B

SELECT PARAMETER

STANDARD SELECTION

TOGGLE ONE/ALL

RETURN

Figure 5.15:
CUSTOMIZE PRINTOUT

Customize QC Printout Screen

The [CUSTOMIZE PRINTOUT] key on the QC SET UP MENU screen is 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 is the RBC/PLT Count Time. RCT2 is the RBC/PLT Count Time for an extended count. WUT is the WIC Upper Metering Time. WCT is the WIC Count Time. WIC is the WBC Impedance Count. WOC is the WBC Optical Count.

RCT1 and RCT2

WUT WCT WIC WOC


SELECT PARAMETER

The [SELECT PARAMETER] key is used to select parameters and place them in the desired location. The [STANDARD SELECTION] key is used to automatically arrange the parameters in the predetermined print group shown in the preceding figure.

STANDARD SELECTION

TOGGLE ONE/ALL

The [TOGGLE ONE/ALL] key is used to customize one file only or 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 35 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 Ready

Nov 18 1998 Operator ID Sequence #

08:49 0067

The X-B RBC program is ON.

1
Parameter MCV MCH MCHC Parameter LYM 0D LYM 10D NEU 0D NEU 10D NEU 90D NEU 90DEP NEU-EO Lower/Upper Limits 55.0/125. fL 20.0/40.0 pg 24.0/44.0 g/dL Lower/Upper 48/ 70 51/ 67 141/179 128/170 87/163 11/ 31 14.0/ 32.0

2
Target Value 89.9 fL 30.5 pg 33.9 g/dL

3
Action Limit 3.0 % 3.0 % 3.0 % Action Limit 7.0 % 5.0 % 4.0 % 5.0 % 10.0 % 19.0 % 13.0 %

The X-B WBC program is ON. Limits Target Value Channel 59 Channel Channel 59 Channel Channel 160 Channel Channel 149 Channel Channel 125 Channel Channel 21 Channel Degree 23.0 Degree

TURN X-B RBC OFF

TURN X-B WBC OFF

PRINT

RETURN

Figure 5.16:
X-B SET UP

X-B Set Up Screen

The [X-B SET UP] key on the QC SET UP MENU screen is used to 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 TURN X-B WBC ON or TURN X-B WBC OFF PRINT RETURN

(This key label alternates between these two selections.) (This key label alternates between these two selections.)

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Set Up Instructions

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 Ready

Dec 08 1998 Operator ID Sequence #

16:11 rwe 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 VET PKG

TURN ON RETIC PKG

BAR CODE SET UP

COMPUTER SET UP

RETURN

Figure 5.17:
OPERATION SET UP

Operation Set Up Menu Screen

The [OPERATION SET UP] key on the SET UP MENU screen is used to 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 TURN ON RETIC PKG or TURN OFF RETIC PKG BAR CODE SET UP COMPUTER SET UP RETURN

(This key label alternates between these two selections.) (This key label alternates between these two selections.)

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Turn ON Vet Package Soft Key


TURN ON VET PKG TURN VET PKG OFF

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

Turn ON Retic Package Soft Key


TURN ON RETIC PKG TURN OFF RETIC PKG

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

Bar Code Set Up Soft Key

BAR CODE SET UP Ready

Dec 08 1998 Operator ID Sequence #

16:12 agw 0068

ON 1

Bar Code Check Digit 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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BAR CODE SET UP

The [BAR CODE SET UP] key is used to display the 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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Computer Set Up Soft Key

COMPUTER SET UP Ready

Dec 08 1998 Operator ID Sequence #

16:13 smw 0070

1 2 3 4 5

OFF OFF OFF OFF OFF 8 1 0 0.3 9600

Auto-transmission of ALERTED parameter data Auto-transmission of NON-ALERTED parameter data Auto-transmission of ALERTED graph data Auto-transmission of NON-ALERTED graph data 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)

REINIT INTERFACE

STOP TRANSMISS

TOGGLE ON/OFF

SET UP

Figure 5.19:
COMPUTER SET UP

Computer Set Up Screen

The [COMPUTER SET UP] key on the OPERATION SET UP MENU screen 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 operators 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 online 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 INTERFACE

The [REINIT INTERFACE] key on the COMPUTER SET UP screen is used 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 TRANSMISS

The [STOP TRANSMISS] key stops the current data transmission to 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 ON/OFF

The [TOGGLE ON/OFF] key enables or disables the first five options 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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Set Up Instructions

Units Selection Soft Key

UNITS SELECTION Ready

Dec 08 1998 Operator ID Sequence #

16:16 rsj 0070

Parameters WBC RBC HGB HCT RDW PLT PCT

USA K/L M/L g/dL % % K/L %

SI G/L T/L g/L L/L %CV G/L mL/L

SI MOD 10e9/L 10e12/L mmol/L L/L %CV 10e9/L mL/L

SET 1 10e3/L 10e6/L g/L % %CV 10e3/L %

SET 2 10e2/L 10e4/L g/dL % % 10e4/L %

USA UNITS

SI UNITS

SI MOD UNITS

SET 1 UNITS

SET 2 UNITS

SELECT UNITS

RETURN

Figure 5.20:
UNITS SELECTION

Units Selection Screen

The [UNITS SELECTION] key on the SET UP MENU screen is used to 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 Value


5.32 5.15 162 0.476 92.3 31.5 341 12.5 323 8.26 2.67 17.5

SI MOD Units
G/L T/L g/L L/L fL pg g/L %CV G/L fL mL/L 10GSD

SET 1 Value
5.32 5.15 162 47.6 92.3 31.5 341 12.5 323 8.26 0.267 17.5

SET 2 Value
53.2 515. 16.2 47.6 92.3 31.5 34.1 12.5 32.3 8.26 0.267 17.5

Parameter WBC* RBC HGB HCT MCV MCH MCHC RDW PLT MPV PCT*** PDW**, ***

Value
5.32 5.15 16.2 47.6 92.3 31.5 34.1 12.5 323 8.26 0.267 17.5

Units
K/L M/L g/dL % fL pg g/dL % K/L fL % 10GSD

Value
5.32 5.15 10.1 0.476 92.3 1.96 21.2 12.5 323 8.26 2.67 17.5

Units
10e9/L 10e12/L mmol/L L/L fL fmol mmol/L %CV 10e9/L fL mL/L 10GSD

Units
10e3/L 10e6/L g/L % fL pg g/L %CV 10e3/L fL % 10GSD

Units
10e2/L 10e4/L g/dL % fL pg g/dL % 10e4/L fL % 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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Set Up Instructions 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 REPORT

The [CUSTOMIZE REPORT] key on the SET UP MENU screen is used to 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 Ready

CUSTOMIZE PRINTOUT HEADER Ready

PARAM SET 1

PARAM SET 2

PARAM SET 3

PARAM SET 4

CUSTOMIZE CUSTOMIZE PRINTOUT HEADER

SELECT GRAPH

SET UP

RESTORE HEADER

BLANK CUSTOMIZE CUSTOMIZE HEADER DISPLAY PRINTOUT

SET UP

PARAM SET 1

PARAM SET 2

PARAM SET 3

PARAM SET 4

CUSTOMIZE CANCEL PRINTOUT GRAPH

PLACE GRAPH

SET UP

CUSTOMIZE PRINTED REPORT Ready

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

SET UP

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 Ready PARAMETER SET 1 SELECTED ON ON ON ON ON ON ON ON ON ON ON ON ON WBC NEU LYM MONO EOS BASO RBC HGB HCT MCV MCH MCHC RDW Size-Cmp (0-10) Grn-Lob (90D-90) 10 deg-90 deg 0 deg-90 deg 10 deg-90 deg D 0 deg-90 deg D N-L-M Histogram M-P Histogram RBC Histogram PLT Histogram WIC Histogram Empty

Dec 21 1998 Operator ID Sequence #

16:57 SH 0630

ON ON ON ON ON

%N %L %M %E %B

Size-Cmp (0-10)

Grn-Lob (90D-90)

ON PLT ON MPV Auto-Sampler Busy PARAM SET 2 PARAM SET 3 PARAM SET 4

RBC Histogram

PLT Histogram

CUSTOMIZE PRINTOUT

CUSTOMIZE HEADER

SELECT GRAPH

SET UP

Figure 5.21:
CUSTOMIZE DISPLAY

Customize Displayed Report Screen

The CUSTOMIZE DISPLAYED REPORT screen (see the preceding 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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PARAM SET X

Using the [PARAM SET X] key, the display can be customized for 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 38 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 310. 12. Press the [SET UP] key to return to the SET UP MENU screen.

Customize Printed Report


CUSTOMIZE PRINTOUT

The CUSTOMIZE PRINTED REPORT screen will be displayed when 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.) (This key label appears only when the [BLANK TICKET] key is selected.)

RESTORE HEADER

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 DISPLAY

The [CUSTOMIZE DISPLAY] key is used to switch to the CUSTOMIZE DISPLAYED REPORT screen (discussed in the preceding section). The [STOP PRINTING] key is used to stop printing that is in 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.

STOP PRINTING

CUSTOMIZE HEADER

The [CUSTOMIZE HEADER] key is used to move to the CUSTOMIZE PRINTOUT HEADER screen (discussed in the following section). The [TOGGLE ON/OFF] key enables or disables the option selected by the position of the cursor. The key label is not displayed when a numeric entry is required. The [SET UP] key is used to return to the SET UP MENU screen.

TOGGLE ON/OFF

SET UP

Ticket Printer Soft Keys


TICKET PRINTER

Two options are available when the [TICKET PRINTER] key is pressed: BLANK TICKET or PRE-PRNTD TICKET

(This key label alternates between these two selections when the soft key is pressed.)

BLANK TICKET PRE-PRINTD TICKET

The [PRE-PRNTD TICKET] key is used to customize the printed report for a preprinted ticket. The [BLANK TICKET] key is used to customize the printed report for a blank ticket.

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Pre-Printed Ticket Soft Key

CUSTOMIZE PRINTED REPORT Ready

Dec 18 1998 Operator ID Sequence #

08:58 sh 0630

1 2 3 4

OFF OFF OFF OFF

TICKET PRINTER - PRE-PRINTED TICKET AUTO-PRINT results for ALERTED specimens AUTO-PRINT results for NON-ALERTED specimens Print PCT, PDW results

BLANK TICKET

GRAPHICS PRINTER

CUSTOMIZE DISPLAY

STOP PRINTING

CUSTOMIZE HEADER

TOGGLE ON/OFF

SET UP

Figure 5.22:
PRE-PRINTD TICKET

Customize Printed Report Screen for Pre-Printed Tickets

The [PRE-PRNTD TICKET] key is used to display the CUSTOMIZE 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. Set Up Instructions

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 Ready

Dec 18 1998 Operator ID Sequence #

08:57 sh 0630

1 ON 2 3 4 5 6 7 8 9 10 OFF OFF OFF OFF OFF OFF OFF 68 2

TICKET PRINTER - BLANK TICKET AUTO-PRINT results for ALERTED specimens AUTO-PRINT results for NON-ALERTED specimens Print PCT, PDW results Print Limits Report Print Specific Alerts Print Manual Differential Grid for ALERTED specimens Print Manual Differential Grid for NON-ALERTED specimens Line-feeds per page for ticket printer (1 to 99) Number of lines for the customize ticket header (0 to 2) . . . . . . . . . 1 . . . . . . . . . .2 . . . . . . . . . . 3 . . . . . . . . . . . . .

RESTORE HEADER

PRE-PRNTD TICKET

GRAPHICS PRINTER

CUSTOMIZE DISPLAY

STOP PRINTING

CUSTOMIZE HEADER

TOGGLE ON/OFF

SET UP

Figure 5.23:
BLANK TICKET

Customize Printed Report Screen for Blank Tickets

The [BLANK TICKET] key is used to display the 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 NONALERTED 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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Set Up Instructions

CUSTOMIZE PRINTED REPORT Ready

Dec 20 1998 Operator ID Sequence #

16:58 sh 0630

GRAPHICS PRINTER 1 2 3 4 5 6 7 8 9 10 11 12 OFF OFF OFF OFF ON ON OFF OFF OFF OFF 66 OFF AUTO-PRINT results for ALERTED specimens AUTO-PRINT results for NON-ALERTED specimens Print graphs for ALERTED specimens only Print PCT, PDW results Print X-B RBC Program status Print X-B WBC Program status Print Interpretive Report Print Limits Report Print Manual Differential Grid for ALERTED specimens Print Manual Differential Grid for NON-ALERTED specimens Line-feeds per page for graphics printer (1 to 99) Color Printing

TICKET PRINTER

CUSTOMIZE DISPLAY

STOP PRINTING

CUSTOMIZE HEADER

TOGGLE ON/OFF

SET UP

Figure 5.24:
GRAPHICS PRINTER

Customize Printed Report Screen for the Graphics Printer

The [GRAPHICS PRINTER] key is used to display the 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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Set Up Instructions 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 NONALERTED 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 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.

Chapter 5

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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 Ready

Dec 17 1998 Operator ID Sequence #

16:58 sh 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 HEADER

BLANK HEADER

CUSTOMIZE DISPLAY

CUSTOMIZE PRINTOUT

SET UP

Figure 5.25:
CUSTOMIZE HEADER

Customize Printout Header Screen for the Graphics Report

The CUSTOMIZE PRINTOUT HEADER screen is displayed when the [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 HEADER

The [BLANK HEADER] key is used to erase the current header.

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RESTORE HEADER

The [RESTORE HEADER] key is used to restore the header to the 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. The [CUSTOMIZE DISPLAY] key is used to switch to the CUSTOMIZE DISPLAYED REPORT screen (discussed in the preceding section). The [CUSTOMIZE PRINTOUT] key is used to switch to the CUSTOMIZE PRINTED REPORT screen (discussed in the preceding section). The [SET UP] key is used return to the SET UP MENU screen.

CUSTOMIZE DISPLAY

CUSTOMIZE PRINTOUT

SET UP

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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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
Next ID -----------Auto Patient ---------------Sex(M/F):- DOB:--/--/-Dr ---------------------Param : 1 Limits: 1 WBC K/uL NEU %N LYM %L MONO %M EOS %E BASO %B RBC HGB HCT MCV MCH MCHC RDW PLT MPV CLEAR APERTURES M/uL g/dL % fL pg g/dL % K/uL fL WORK LIST SPECIMEN TYPE CUSTOMIZE REPORT

1 2 3 4 5

RUN Ready XB RBC: XB WBC:

Dec 18 1998 Operator ID Sequence # WL:OFF G R A N L R T Y

09:02 sh 0630 Open Sampler

S I Z E

COMPLEXITY

LOBULARITY

PLT CHANGE SAMPLER PRINT TICKET PRINT REPORT

RBC MAIN

Figure 5.26:
RUN

Run Screen for Patient Samples

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 WORK LIST SPECIMEN TYPE CUSTOMIZE REPORT CHANGE SAMPLER or TOGGLE AUTO ID PRINT TICKET PRINT REPORT or COLOR PRINT MAIN (This key label changes to [COLOR PRINT] when the color printing option is selected.) (This key label alternates between these two selections.)

(This key label alternates between these three selections.)

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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 15 (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. Used to enter the patients name or identification. (Up to 16 characters may be entered.)

2. <PATIENT>

NOTE: If the resistant RBC RUN screen is selected, <RES RBC> will be displayed on this entry field. 3. <SEX (M/F):/DOB: --/--/--> 4. <DR> Used to enter the sex and birth date of the patient.

Used to enter the name of the patients 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 (14) 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 2 3 5 6

Next ID -----------Auxiliary---------------NOTE-------------- DOB:--/--/-- 4 Rslts Multiplied by 1.00 Param: 1 Limits: 1 WBC NEU %N LYM %L MONO %M EOS %E BASO %B RBC HGB HCT MCV MCH MCHC RDW PLT MPV CLEAR APERTURES M/uL g/dL % fL pg g/dL % K/uL fL SPECIMEN TYPE

RUN Ready

Dec 01 1998 Operator ID Sequence # WL:OFF G R A N L R T Y COMPLEXITY

09:43 022 547 Open Sampler

S I Z E

LOBULARITY

PLT CUSTOMIZE REPORT PRINT REPORT

RBC

MAIN

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). Indicates that the Auxiliary Specimen Type is selected. If desired, the patients name may be entered in this field. (Up to 16 alphanumeric characters may be entered.) 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.) Used to enter the birth date of the patient.

2. <AUXILIARY>

3. <NOTE>*

4. <DOB: --/--/-->

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 (14) 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. Indicates the Parameter Set applied to the results.

Param Set:

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 ---------------Operator ID rcs Ready Sex(M/F):- DOB:--/--/-Sequence # 0843 Open Sampler Dr ---------------------XBRBC: 13/IN XBWBC: 4/IN WL: OFF Param: 1 Limits: 1 SUSPECT G WBC 8.34 K/uL R NEU 4.97 59.6 %N S A I LYM 2.50 29.9 %L VAR LYM N Z L MONO .551 6.61 %M 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 MPV 360. 10.4 K/uL fL WORK LIST

RCT:6.63 RBC Auto-Sampler Ready SPECIMEN TYPE CUSTOMIZE REPORT CHANGE SAMPLER PRINT TICKET

PLT PRINT REPORT MAIN

CLEAR APERTURES

Figure 5.28:

Run Screen Showing Count Times and Flagging Messages

Next ID -----------Auto Patient ---------------Sex(M/F):- DOB:--/--/-Dr ---------------------Param: 1 Limits: 1 WBC 7.93 K/uL NEU 4.71 59.4 %N LYM 2.39 30.1 %L MONO .557 7.03 %M EOS .178 2.25 %E BASO .092 1.16 %B RBC HGB HCT MCV MCH MCHC RDW PLT MPV CLEAR APERTURES M/uL g/dL % fL pg g/dL % K/uL fL WORK LIST

RUN Ready XBRBC: 12/IN XBWBC: 3/IN WL: OFF

Dec 21 1998 Operator ID Sequence # G R A N L R T Y COMPLEXITY

16:27 rcs 0842 Open Sampler

S I Z E WCT: 4.43

LOBULARITY

16.1

RBC CLOG RUT: 8.86 RCT: 0.00 RBC Auto-Sampler Ready SPECIMEN TYPE CUSTOMIZE REPORT CHANGE SAMPLER PRINT TICKET

PLT PRINT REPORT MAIN

Figure 5.29:

Run Screen Showing Flagging Messages, RBC CLOG Message, and RBC Up Time 5-73

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Next ID -----------Auto RUN Dec 21 1998 16:29 Ready Patient ---------------Operator ID rcs Report for XXX Sex(M/F):- DOB:--/--/-Sequence # 0843 Open Sampler Dr ---------------------XBRBC: 13/IN XBWBC: 4/IN WL: OFF Param: 1 Limits: 1 SUSPECT G WBC 8.34 K/uL R NEU 4.97 59.6 %N S A I LYM 2.50 29.9 %L VAR LYM N Z L MONO .551 6.61 %M 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 MPV 360. 10.4 K/uL fL WORK LIST

RCT:6.63 RBC Auto-Sampler Pause SPECIMEN TYPE CUSTOMIZE REPORT CHANGE SAMPLER PRINT TICKET

PLT PRINT REPORT MAIN

CLEAR APERTURES

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 APERTURES CLEAR FAULT PRIME

The [CLEAR APERTURES] key is used to initiate a special cleaning sequence that flushes the WIC and RBC/PLT Apertures to remove obstructions. The sequence takes approximately 35 seconds. When the [CLEAR APERTURES] key is pressed, the message CLEARING 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 Ready

Dec 18 1998 Operator ID Sequence #

09:48 sh 0630

BAR CODE ON # 1 4DIG BC SPECIMEN ID SPECIMEN NAME L 1 P 1 DOCTOR DATE OF BIRTH --/--/-S RACK/ TUBE

WORK LIST ON

BAR CODE OFF

INSERT/ DELETE

DELETE ALL

PURGE COMPLETED

WORK LIST SET UP

PRINT WORK LIST

RETURN

Figure 5.31:

Work List Screen

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WORK LIST

The [WORK LIST] key is used to display the WORK LIST screen (see the preceding figure). The following soft key labels are displayed on the WORK LIST screen: WORK LIST ON or WORK LIST OFF BAR CODE ON or BAR CODE OFF (This key label alternates between these two selections.) (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 Ready

Dec 20 1998 Operator ID Sequence #

09:55 sh 0630

File Name 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Low Normal High low normal high Replicate FILE 8 FILE 9 FILE 10

# Specimens 11 13 0 0 0 0 0 0 0 0 11. 12. 13. 14. 15. 16. 17. 18. 19. 20.

File Name Patient File 12 FILE 13 FILE 14 FILE 15 FILE 16 FILE 17 LOW 11 NORMAL 11 HIGH 11

# Specimens 30 0 0 0 0 0 0 0 0 0

Press QC SPECIMEN key to select QC FILE at cursor position.

PATIENT

QC SPECIMEN

BACKGROUND

ELECTRICL BACKGRND

LATEX

RESISTANT RBC

AUXILIARY

RETURN

Figure 5.32:
SPECIMEN TYPE

Specimen Type Screen

The [SPECIMEN TYPE] key on the RUN screen is used to select the 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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Patient Soft Key

Next ID ------------ Auto Patient ---------------Sex(M/F):-DOB:--/--/-Dr ---------------------Param: 1 Limits: 1 WBC K/uL NEU %N LYM %L MONO %M EOS %E BASO %B RBC HGB HCT MCV MCH MCHC RDW PLT MPV CLEAR APERTURES M/uL g/dL % fL pg g/dL % K/uL fL WORK LIST

RUN Ready XBRBC: 13/IN XBWBC: 4/IN WL: OFF

Dec 21 1998 Operator ID Sequence #

16:30 sh 0630 Closed Sampler

S I Z E WCT: COMPLEXITY

G R A N L R T Y LOBULARITY

RCT:

PLT Auto-Sampler Ready CHANGE SAMPLER PRINT TICKET

RBC PRINT REPORT MAIN

SPECIMEN TYPE

CUSTOMIZE REPORT

Figure 5.33:
PATIENT

Run Screen for Patient Samples

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

Type Low Param Set: 1

11/120

RUN Ready WL:OFF

Dec 18 1998 Operator ID Sequence # G R A N L R T Y COMPLEXITY

09:52 sh 0630 Open Sampler

WBC NEU LYM MONO EOS BASO RBC HGB HCT MCV MCH MCHC RDW PLT MPV CLEAR APERTURES

K/uL %N %L %M %E %B WCT: M/uL g/dL % fL pg g/dL % K/uL fL WORK LIST S I Z E

LOBULARITY

RCT: SPECIMEN TYPE CUSTOMIZE REPORT

PLT CHANGE SAMPLER PRINT TICKET

RBC PRINT REPORT MAIN

Figure 5.34:
QC SPECIMEN

Run Screen for a QC File

The [QC SPECIMEN] key on the SPECIMEN TYPE screen is used 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

Type BACKGROUND Param Set: 1

RUN Ready WL:OFF

Dec 18 1998 Operator ID Sequence # G R A N L R T Y COMPLEXITY

09:52 sh 0630 Open Sampler

WBC NEU LYM MONO EOS BASO RBC HGB HCT MCV MCH MCHC RDW PLT MPV CLEAR APERTURES

K/uL %N %L %M %E %B WCT: M/uL g/dL % fL pg g/dL % K/uL fL WORK LIST S I Z E

LOBULARITY

RCT: SPECIMEN TYPE CUSTOMIZE REPORT

PLT CHANGE SAMPLER PRINT TICKET

RBC PRINT REPORT MAIN

Figure 5.35:
BACKGROUND

Run Screen for Background Counts

The [BACKGROUND] key on the SPECIMEN TYPE screen is used to 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

Type ELEC BKGND Param Set: 1

RUN Ready WL:OFF

Dec 18 1998 Operator ID Sequence # G R A N L R T Y COMPLEXITY

09:52 sh 0630 Open Sampler

WBC NEU LYM MONO EOS BASO RBC HGB HCT MCV MCH MCHC RDW PLT MPV CLEAR APERTURES

K/uL %N %L %M %E %B WCT: M/uL g/dL % fL pg g/dL % K/uL fL WORK LIST S I Z E

LOBULARITY

RCT: SPECIMEN TYPE CUSTOMIZE REPORT

PLT CHANGE SAMPLER PRINT TICKET

RBC PRINT REPORT MAIN

Figure 5.36:
ELECTRICL BACKGRND

Run Screen for Electrical Background Counts

The [ELECTRICL BACKGRND] key on the SPECIMEN TYPE screen is 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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Chapter 5 Resistant RBC Soft Key

Next ID _ _ _ _ _ _ _ _ Auto ResRBC Sex (M/F): _ DOB: - -/- -/- Dr: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Param : 1 Limits: 1 WBC NEU %N LYM %L MONO %M EOS %E BASO %B RBC HGB HCT MCV MCH MCHC RDW PLT MPV CLEAR APERTURES M/uL g/dL % fL pg g/dL % K/uL fL WORK LIST

RUN Ready XBRBC: 1/IN XBWBC: 0/IN WL:OFF

Dec 01 1998 Operator ID Sequence # G R A N L R T Y COMPLEXITY

09:52 022 547 Open Sampler

S I Z E

LOBULARITY

PLT SPECIMEN TYPE CUSTOMIZE REPORT CHANGE SAMPLER PRINT TICKET

RBC PRINT REPORT MAIN

Figure 5.37:
RESISTANT RBC

Run Screen for Resistant RBC Specimen Type

The [RESISTANT RBC] key is used to select the Resistant RBC mode. 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 Ready

Dec 18 1998 Operator ID Sequence #

09:42 123 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 SPECIMEN

CANCEL SPECIMEN

Figure 5.38:

Auxiliary Specimen Type Screen

Procedure: Auxiliary
1. Dilute the specimen with Diluent according to your laboratorys 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 Auxiliary Note DOB: Rslts Multiplied by 3.00 Param: Limits: WBC K/uL NEU %N LYM %L MONO %M EOS %E BASO %B WCT: RBC HGB HCT MCV MCH MCHC RDW PLT MPV CLEAR APERTURES M/uL g/dL % fL pg g/dL % K/uL fL

RUN Ready WL:OFF

Dec 18 1998 Operator ID Sequence # G R A N L R T Y COMPLEXITY

09:52 sh 0630 Open Sampler

S I Z E

LOBULARITY

RCT: SPECIMEN TYPE CUSTOMIZE REPORT

PLT

RBC PRINT REPORT MAIN

Figure 5.39:

Run Screen for the Auxiliary Specimen Type

Customize Report Soft Key


CUSTOMIZE REPORT

The [CUSTOMIZE REPORT] key on the RUN screen is discussed earlier in this chapter, in Set Up Instructions, Customize Report Soft Key.

Change Sampler Soft Key


CHANGE SAMPLER

The [CHANGE SAMPLER] key on the RUN screen is used to select the 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 TICKET

The [PRINT TICKET] key on the RUN screen is used to print a report 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 REPORT COLOR PRINT

The [PRINT REPORT] key on the RUN screen is used to print a graphics report when the Graphics Printer is connected to the Data Station. When the Color Graphics Printer is connected to the Data 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 manufacturers 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 manufacturers 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 13 mL of blood. The specimen volume in this tube ensures proper mixing by the Sample Loader. A minimum of 180 L should be collected for capillary specimens. This ensures an adequate amount of blood for the Open Mode aspiration (130 L). 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 Elevated WBC count, increased numbers of giant PLTS, auto-agglutination, in vitro hemolysis Elevated WBC count, increased plasma substances (triglycerides, bilirubin, in vivo hemolysis), lyticresistant RBCs. elevated WBC count, hyperglycemia, in vitro hemolysis, increased numbers of giant PLTs. WBC fragments, in vitro hemolysis, microcytic RBCs, cryofibrinogen, cryoglobulins, PLT clumping, increased numbers of giant PLTs.
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RBC: HGB:

MCV:

PLT:

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Retics: Routine Operation 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 AutoIncrement 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 operators 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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Routine Operation 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 parameters 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 operators 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 operators 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 laboratorys protocol. Commercial control materials should be properly warmed and mixed according to the manufacturers recommendations. Patient controls should be handled according to the laboratorys 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 810 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 manufacturers 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 610 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 69 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 1114 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. Routine Operation

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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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 laboratorys protocol. Commercial control materials should be properly warmed and mixed according to the manufacturers recommendations. Patient controls should be handled according to the laboratorys 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 LIST

The [WORK LIST] key on the Data Station RUN screen is used to 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 BAR CODE ON or BAR CODE OFF INSERT/DELETE DELETE ALL PURGE COMPLETED WORK LIST SET UP PRINT WORK LIST RETURN

(This key label alternates between these two selections.) (This key label alternates between these two selections.)

1 2

Work List ON

WORK LIST Ready

Dec 07 1998 Operator ID Sequence #

12:09 753 0330

Bar Code ON

3
# 11 2 3 4 5 6

4
4DIG BC

5
SPECIMEN ID 123456 234567 345678 456789 567890

6
SPECIMEN NAME Jones, Mary Smith, John White, Bob Black, Sue Green, Kermit

7
L 1

8
P 1

9
DOCTOR 1 1 1 1 1 1

10
DATE OF BIRTH 1 --/--/-- N A 1 F 1 1 1 1

11
S

12
RACK/ TUBE

WORK LIST OFF

BAR CODE OFF

INSERT/ DELETE

DELETE ALL

PURGE COMPLETED

WORK LIST SET UP

PRINT WORK LIST

RETURN

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 patients 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 A Non-Alerted The sample was not flagged in any way. Alerted The sample was flagged because results exceeded the selected Patient Limits or because a morphological flag was generated. 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 LIST ON WORK LIST OFF

The [WORK LIST ON] key is used to turn on the Work List feature. The key label changes to [WORK LIST OFF] when the Work List feature is enabled. The upper left-hand corner of the screen indicates the status of the Work List.

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Bar Code ON/Bar Code OFF Soft Key


BAR CODE ON BAR CODE OFF

The [BAR CODE ON] key is used to create a Work List for samples that are identified with bar code labels. The key label changes to [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/ DELETE

When the [INSERT/DELETE] key is pressed, the following soft key 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 ALL

The [DELETE ALL] key is used to delete all data from the Work List. 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 COMPLETED

The [PURGE COMPLETED] key is used to delete all Work List entries 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 Ready

Dec 18 1998 Operator ID Sequence #

10:09 sh 0630

1 1

Bar Code ID associated with : 1 = 4-digit bar code 2 = Laboratory Specimen ID Specimen Name entry selected Patient Limits entry selected Default Patient Limit Set (1..4) Parameter Set entry selected Default Parameter Set (1..4) Doctor Name entry selected Date of Birth entry selected TOGGLE ON/OFF RETURN

2 OFF 3 OFF 4 1 5 OFF 6 1 7 OFF 8 OFF

Figure 5.41:

Work List Set Up Screen

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WORK LIST SET UP

The [WORK LIST SET UP] key on the WORK LIST screen is used to 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 patients date of birth will be entered in the Work List.

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Print Work List Soft Key


PRINT WORK LIST

The [PRINT WORK LIST] key is used to print the 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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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 laboratorys 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. Routine Operation

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 (preassigned) 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 (preassigned) 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 4digit 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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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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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 Ready USE < OR > FOR MORE DATA

Dec 21 1998 Operator ID Sequence #

16:32 rcs 0844

Seq 833 834 835 836 837 838 839 840 841 w 842 b 843 844 r r r r r r

Specimen ID 1912584436 1910952241 1912077932 1911764321 1911815501 1911187621 low ctrl low ctrl low ctrl

BACKGROUND

WBC 3.83 7.50 .192 6.26 4.37 7.07 8.06 7.96 8.21 7.93 8.34 .079

NEU 2.30 4.53 .052 4.99 2.75 6.02 4.71 4.78 4.86 4.71 4.97

LYM .315 2.16 .116 .828 .984 .612 2.44 2.32 2.45 2.39 2.50

MONO 1.04 .536 .012 .252 .519 .218 .621 .601 .598 .557 .551

EOS .012 .106 .002 .019 .001 .069 .213 .183 .204 .178 .208

BASO .173 .141 .010 .176 .116 .150 .074 .080 .099 .092 .114

Date C07/21/98 C07/21/98 C07/21/98 C07/21/98 C07/21/98 C07/21/98 O07/21/98 O07/21/98 O07/21/98 K07/21/98 O07/21/98 O07/21/98

Time 14:40 14:40 14:41 14:42 14:43 14:43 16:20 16:20 16:21 16:26 16:28 16:30

Op rcs rcs rcs rcs rcs rcs rcs rcs rcs rcs rcs rcs

Seq EDIT ID

Specimen ID DISPLAY SPECIMEN

WBC

NEU

LYM

MONO EOS

BASO TRANSMIT DATA

Date PRINT DATA LOG

Time

Op MAIN

FIND SPECIMEN

REJECT FROM X-B

CUSTOMIZE 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 LOG

The [DATA LOG] key on the MAIN MENU is used to display the DATA 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 ID

The [EDIT ID] key is used to edit the specimen ID displayed on the 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 Patient ---------------Ready Sex(M/F):- DOB:--/--/-Dr ---------------------Sequence # 826 Param: 2 Limits: 1 SUSPECT WBC 7.28 K/uL (WOC) NEU 4.51 62.0 %N S I LYM 1.81 24.9 %L VAR LYM Z MONO .745 10.2 %M NRBC E EOS .097 1.33 %E BASO .111 1.53 %B DFLT (LM) WCT:4.46 RBC 4.05 M/uL COMPLEXITY 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 MPV PREVIOUS SPECIMEN 266. 9.05 K/uL fL

Dec 07 1998 Operator ID Sequence # G R A N L R T Y

08:19 baC 0863 Closed Sampler

LOBULARITY

RCT:6.53 RBC Auto-Sampler Ready EDIT SPECIMEN CUSTOMIZE REPORT TRANSMIT SPECIMEN PRINT TICKET

PLT PRINT REPORT RETURN

NEXT SPECIMEN

Figure 5.43:
DISPLAY SPECIMEN

Display Specimen Screen

The [DISPLAY SPECIMEN] key on the DATA LOG screen is used to 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 EDIT SPECIMEN 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.) This label key is not displayed when the last specimen in the log is on the screen. This label key is displayed for the patient records only.

RETURN

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Previous Specimen Soft Key


PREVIOUS SPECIMEN

The [PREVIOUS SPECIMEN] key on the DISPLAY SPECIMEN screen is 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 SPECIMEN

The [NEXT SPECIMEN] key is used to display the results for the sequence number following the one currently displayed without returning to the main DATA LOG screen.

Edit Specimen Soft Key


EDIT SPECIMEN

The [EDIT SPECIMEN] key is used to edit patient demographic 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 REPORT

The [CUSTOMIZE REPORT] key is used to customize the RUN screen display, header, and printout as described in Set Up Instructions within this chapter.

Transmit Specimen Soft Key


TRANSMIT SPECIMEN

The [TRANSMIT SPECIMEN] key is used to transmit the displayed report to a Laboratory Information System or on-line computer.

Print Ticket Soft Key


PRINT TICKET

The [PRINT TICKET] key is used to print a ticket (in the currently selected format) for the displayed record.

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Print Report Soft Key


PRINT REPORT COLOR PRINT

The [PRINT REPORT] key is used to print a graphics report (in the currently selected format) for the displayed record. 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: NAME:

DATA LOG SEARCH Ready

Dec 21 1998 Operator ID Sequence #

15:56 rcs 0711

b r

r r

Seq 700 701 702 703 704 705 706 707 708 709 710 711

Specimen ID BACKGROUND 1911937231 1911359331 1911883246 LATEX LATEX BACKGROUND 1912696001 1911187621 1912395001 1910851733 BACKGROUND

WBC .006 9.42 5.52 11.4 3.25 3.25 .035 7.96 8.10 6.88 9.53 .013

WIC .006 9.89 6.44 11.9 1.71 1.64 .009 8.21 8.23 7.75 9.91 .013

WOC .006 9.42 5.52 11.4 3.25 3.25 .035 7.96 8.10 6.88 9.53 .013

RBC 0.00 3.76 3.88 0.00 0.00 0.00 3.33 3.29 3.77 3.77 .001

HGB .027 10.1 10.2 10.1 .081 .061 .027 9.54 9.94 11.5 10.7 .027

MCV 82.0 81.4

RDW 16.8 13.3

89.8 90.5 91.9 85.8

14.8 15.4 13.1 16.4

Date O07/20/98 C07/20/98 C07/20/98 K07/20/98 O07/20/98 O07/20/98 O07/20/98 C07/20/98 C07/20/98 C07/20/98 C07/20/98 O07/20/98

Time 14:38 14:42 14:43 14:43 14:50 14:51 14:53 14:57 14:57 14:58 14:59 15:47

Op rcs rcs rcs rcs rcs rcs rcs rcs rcs rcs rcs rcs

Seq EDIT ID

Specimen ID DISPLAY SPECIMEN

WBC

WIC

WOC

RBC

HGB

MCV

RDW TRANSMIT DATA

Date PRINT DATA LOG

Time

Op MAIN

FIND SPECIMEN

REJECT FROM X-B

CUSTOMIZE DATA LOG

Figure 5.44:
FIND SPECIMEN

Data Log Search Screen

The [FIND SPECIMEN] key on the DATA LOG screen is used to locate a 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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Reject From X-B/Accept Into X-B Soft Key


REJECT FROM X-B ACCEPT INTO X-B

The letter b, r, or w will appear to the left of the sequence number for certain samples. 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 Ready USE < OR > FOR MORE DATA

Dec 21 1998 Operator ID Sequence #

15:56 rcs 0711

b r

r r

Seq 700 701 702 703 704 705 706 707 708 709 710 711

Specimen ID BACKGROUND 1911937231 1911359331 1911883246 LATEX LATEX BACKGROUND 1912696001 1911187621 R 1912395001 1910851733 R BACKGROUND

WBC .006 9.42 5.52 11.4 3.25 3.25 .035 7.96 8.10 6.88 9.53 .013

WIC .006 9.89 6.44 11.9 1.71 1.64 .009 8.21 8.23 7.75 9.91 .013

WOC .006 9.42 5.52 11.4 3.25 3.25 .035 7.96 8.10 6.88 9.53 .013

RBC 0.00 3.76 3.88 0.00 0.00 0.00 3.33 3.29 3.77 3.77 .001

HGB .027 10.1 10.2 10.1 .081 .061 .027 9.54 9.94 11.5 10.7 .027

MCV 82.0 81.4

RDW 16.8 13.3

89.8 90.5 91.9 85.8

14.8 15.4 13.1 16.4

Date O12/20/98 C12/20/98 C12/20/98 K12/20/98 O12/20/98 O12/20/98 O12/20/98 C12/20/98 C12/20/98 C12/20/98 C12/20/98 O12/20/98

Time 14:38 14:42 14:43 14:43 14:50 14:51 14:53 14:57 14:57 14:58 14:59 15:47

Op rcs rcs rcs rcs rcs rcs rcs rcs rcs rcs rcs rcs

Seq EDIT ID

Specimen ID DISPLAY SPECIMEN

WBC

WIC

WOC

RBC

HGB

MCV

RDW TRANSMIT DATA

Date PRINT DATA LOG

Time

Op MAIN

Auto-Sampler Pause FIND SPECIMEN REJECT FROM X-B CUSTOMIZE DATA LOG

Figure 5.45:

Data Log Screen Showing Reject From X-B Key

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DATA LOG Ready USE < OR > FOR MORE DATA

Dec 21 1998 Operator ID Sequence #

15:56 rcs 0711

b r w

r b r

Seq 700 701 702 703 704 705 706 707 708 709 710 711

Specimen ID BACKGROUND 1911937231 1911359331 1911883246 LATEX LATEX BACKGROUND 1912696001 1911187621 R 1912395001 1910851733 R BACKGROUND

WBC .006 9.42 5.52 11.4 3.25 3.25 .035 7.96 8.10 6.88 9.53 .013

WIC .006 9.89 6.44 11.9 1.71 1.64 .009 8.21 8.23 7.75 9.91 .013

WOC .006 9.42 5.52 11.4 3.25 3.25 .035 7.96 8.10 6.88 9.53 .013

RBC 0.00 3.76 3.88 0.00 0.00 0.00 3.33 3.29 3.77 3.77 .001

HGB .027 10.1 10.2 10.1 .081 .061 .027 9.54 9.94 11.5 10.7 .027

MCV 82.0 81.4

RDW 16.8 13.3

89.8 90.5 91.9 85.8

14.8 15.4 13.1 16.4

Date O12/20/98 C12/20/98 C12/20/98 K12/20/98 O12/20/98 O12/20/98 O12/20/98 C12/20/98 C12/20/98 C12/20/98 C12/20/98 O12/20/98

Time 14:38 14:42 14:43 14:43 14:50 14:51 14:53 14:57 14:57 14:58 14:59 15:47

Op rcs rcs rcs rcs rcs rcs rcs rcs rcs rcs rcs rcs

Seq EDIT ID

Specimen ID DISPLAY SPECIMEN

WBC

WIC

WOC

RBC

HGB

MCV

RDW TRANSMIT DATA

Date PRINT DATA LOG

Time

Op MAIN

Auto-Sampler Pause FIND SPECIMEN ACCEPT INTO X-B CUSTOMIZE 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 Ready FOR DATA LOG

Dec 18 1998 Operator ID Sequence #

10:29 sh 0630

Group 1: Group 2: Group 3: Group 4:

WBC RBC PLT WBC

NEU HGB MPV %N

LYM HCT PCT %L

MONO EOS MCV PDW %M %E MCH

BASO MCHC RDW

%B

WBC RBC PLT RUT1 WUT

NEU HGB MPV %N RUT2 WCT

LYM HCT PCT %L RCT1 WIC

MONO MCV PDW %M RCT2 WOC

EOS MCH %E EMPTY

BASO MCHC RDW %B

SELECT PARAMETER

STANDARD GROUPS

CUSTOMIZE PRINTOUT

RETURN

Figure 5.47:
CUSTOMIZE DATA LOG

Customize Display for Data Log Screen

The [CUSTOMIZE DATA LOG] key on the DATA LOG screen is used to 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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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 PARAMETER PLACE PARAMETER

The [SELECT PARAMETER] key is used to select a parameter designated by the cursor. When the key is pressed, the selected parameter will be highlighted, the label will change to [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 The [CANCEL SELECTION] key is used to cancel the selection and display the [SELECT PARAMETER] key again.

CANCEL SELECTION

Standard Groups Soft Key

CUSTOMIZE DISPLAY Ready FOR DATA LOG

Dec 18 1998 Operator ID Sequence #

10:29 sh 0630

Group 1: Group 2: Group 3: Group 4:

WBC RBC PLT WBC

NEU HGB MPV %N

LYM HCT

MONO EOS MCV MCH

BASO MCHC RDW

PCT** PDW** %L %M %E %B

WBC RBC PLT RUT1 WUT

NEU HGB MPV %N RUT2 WCT

LYM HCT PCT %L RCT1 WIC

MONO MCV PDW %M RCT2 WOC

EOS MCH %E EMPTY

BASO MCHC RDW %B

WBC GROUP

RBC GROUP

PLT GROUP

DIFF GROUP

CUSTOM PLACEMENT

CUSTOMIZE PRINTOUT

RETURN

Figure 5.48: 5-130

Customize Display Showing Standard Groups


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STANDARD GROUPS

Predetermined groups of parameters, called 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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Customize Printout Soft Key

CUSTOMIZE PRINTOUT Ready FOR DATA LOG

Dec 18 1998 Operator ID Sequence #

10:31 sh 0630

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

RDW PLT MPV PCT PDW

WBC RBC PLT RUT1 WUT

NEU HGB MPV %N RUT2 WCT

LYM HCT PCT %L RCT1 WIC

MONO EOS MCV MCH PDW %M %E RCT2 WOC

BASO MCHC RDW %B

SELECT PARAMETER

STANDARD SELECTION

RETURN

Figure 5.49:
CUSTOMIZE PRINTOUT

Customize Printout for Data Log Screen

The [CUSTOMIZE PRINTOUT] key on the CUSTOMIZE DISPLAY for Data 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 PLACE PARAMETER

Select Parameter Soft Key The [SELECT PARAMETER] key on the CUSTOMIZE PRINTOUT screen is used to select a parameter designated by the cursor. When the key is pressed, the selected parameter is highlighted, the label 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. The [CANCEL SELECTION] key is used to cancel the selection and display the [SELECT PARAMETER] key again. Standard Selection Soft Key The [STANDARD SELECTION] key on the CUSTOMIZE PRINTOUT for 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 The [RETURN] key is used to return to the main DATA LOG screen.

CANCEL SELECTION

STANDARD SELECTION

RETURN

Transmit Data Soft Key


TRANSMIT DATA

The [TRANSMIT DATA] key on the DATA LOG screen is used to 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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Print Data Log Soft Key


PRINT DATA LOG

The [PRINT DATA LOG] key on the DATA LOG screen is used to print 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 Ending Sequence #:

DATA LOG Ready USE < OR > FOR MORE DATA

Dec 21 1998 Operator ID Sequence #

16:33 rcs 0844

Seq Specimen ID 833 1912584436 834 1910952241 835 1912077932 836 1911764321 837 1911815501 838 1911187621 839 low ctrl 840 low ctrl 841 low ctrl 842 b 843 BACKGROUND 844 r r r r r r

WBC 3.83 7.50 .192 6.26 4.37 7.07 8.06 7.96 8.21 7.93 8.34 .079

NEU 2.30 4.53 .052 4.99 2.75 6.02 4.71 4.78 4.86 4.71 4.97

LYM .315 2.16 .116 .828 .984 .612 2.44 2.32 2.45 2.39 2.50

MONO 1.04 .563 .012 .252 .519 .218 .621 .601 .598 .557 .551

EOS .012 .106 .002 .019 .001 .069 .213 .183 .204 .178 .208

BASO .173 .141 .010 .176 .116 .150 .074 .080 .099 .092 .114

Date C12/21/98 C12/21/98 C12/21/98 C12/21/98 C12/21/98 C12/21/98 O12/21/98 O12/21/98 O12/21/98 K12/21/98 O12/21/98 O12/21/98

Time 14:40 14:40 14:41 14:42 14:43 14:43 16:20 16:20 16:21 16:26 16:28 16:30

Op rcs rcs rcs rcs rcs rcs rcs rcs rcs rcs rcs rcs

Seq Specimen ID EDIT ID DISPLAY SPECIMEN

WBC

NEU

LYM

MONO EOS

BASO TRANSMIT DATA

Date PRINT DATA LOG

Time

Op MAIN

Auto-Sampler Ready FIND SPECIMEN REJECT FROM X-B CUSTOMIZE DATA LOG

Figure 5.50:

Print Data Log Screen

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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 Ready FOR DATA LOG

Dec 21 1998 Operator ID Sequence #

10:57 sh 0630

Group 1: Group 2: Group 3: Group 4:

WBC RBC PLT WBC

NEU HGB MPV %N

LYM HCT PCT* %L

MONO EOS MCV PDW* %M %E MCH

BASO MCHC RDW

%B

WBC RBC PLT RUT1 WUT

NEU HGB MPV %N RUT2 WCT

LYM HCT PCT %L RCT1 WIC

MONO MCV PDW %M RCT2 WOC

EOS MCH %E EMPTY

BASO MCHC RDW %B

Auto-Sampler Ready SELECT PARAMETER STANDARD GROUPS CUSTOMIZE PRINTOUT RETURN

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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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 is the RBC/PLT Count Time. RCT2 is the RBC/PLT Count Time for an extended count. WUT is the WIC Upper Metering Time. WCT is the WIC Count Time. WIC is the WBC Impedance Count. WOC is the WBC Optical Count. An empty column is inserted in the display.

RCT1 and RCT2 WUT WCT WIC WOC EMPTY

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 35 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 (14). 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 Ready FOR DATA LOG

Jul 21 1998 Operator ID Sequence #

11:00 sh 0630

WBC WIC WOC %N %L %M %E %B RBC HGB HCT MCV

MCH MCHC RDW PLT MPV

WBC RBC PLT RUT1 WUT

NEU HGB MPV %N RUT2 WCT

LYM HCT PCT* %L RCT1 WIC

MONO EOS MCV MCH PDW* %M %E RCT2 WOC

BASO MCHC RDW %B

Auto-Sampler Ready SELECT PARAMETER STANDARD SELECTION RETURN

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 RCT1 and RCT2 WUT WCT WIC WOC RUT1 is the RBC/PLT Upper Metering Time. RUT2 is the RBC/PLT Upper Metering Time for an extended count. RCT1 is the RBC/PLT Count Time. RCT2 is the RBC/PLT Count Time for an extended count. WUT is the WIC Upper Metering Time. WCT is the WIC Count Time. WIC is the WBC Impedance Count. 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 24 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 Patient ---------------Sex(M/F):- DOB:--/--/-Dr ---------------------Param Set: 1 Limits: 1 WBC 4.97 K/uL NEU 3.53 71.0 %N LYM .813 16.4 %L MONO .450 9.05 %M EOS .103 2.07 %E BASO .074 1.49 %B RBC HGB HCT MCV MCH MCHC RDW PLT MPV 5.48 15.7 58.2 106. 28.7 27.0 14.5 254. 8.38 M/uL g/dL % fL pg g/dL % K/uL fL NEXT SPECIMEN

DISPLAY SPECIMEN Ready Sequence # 346 SUSPECT BANDS S I Z E

Dec 18 1998 11:14 Operator ID sh Sequence # 0630 Closed Sampler G R A N L R T Y

DFLT (NLMEB) WCT:4.29 COMPLEXITY RBC MORPH

LOBULARITY

RCT:6.09 EDIT SPECIMEN CUSTOMIZE REPORT

PLT TRANSMIT SPECIMEN PRINT TICKET

RBC PRINT REPORT RETURN

PREVIOUS SPECIMEN

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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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 Patient ---------------Sex(M/F):- DOB:--/--/-Dr ---------------------Param Set: 1 Limits: 1 WBC 4.97 K/uL NEU 3.53 71.0 %N LYM .813 16.4 %L MONO .450 9.05 %M EOS .103 2.07 %E BASO .074 1.49 %B RBC HGB HCT MCV MCH MCHC RDW PLT MPV 5.48 15.7 58.2 106. 28.7 27.0 14.5 254. 8.38 M/uL g/dL % fL pg g/dL % K/uL fL NEXT SPECIMEN

DISPLAY SPECIMEN Ready Sequence # 346 SUSPECT BANDS S I Z E

Dec 18 1998 11:14 Operator ID sh Sequence # 0630 Closed Sampler G R A N L R T Y

DFLT (NLMEB) WCT:4.29 COMPLEXITY RBC MORPH

LOBULARITY

PLT RCT:6.09 Press CONFIRM to save changes or CANCEL to cancel changes. EDIT SPECIMEN CUSTOMIZE REPORT TRANSMIT SPECIMEN PRINT TICKET

RBC PRINT REPORT RETURN

PREVIOUS SPECIMEN

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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References

References
1. International Committee for Standardization in Haematology (ICSH). Protocol for Evaluation of Automated Blood Cell Counters. Clinical and Laboratory Hematology. 1984; 6:6984. 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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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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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 Bulls 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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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 instruments 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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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 laboratorys 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 RBC HGB MCV PLT 1.9925.0 K/L (WIC and WOC) 2.006.50 M/L 3.9924.0 g/dL 70.0100.0 fL 50.0600.0 K/L

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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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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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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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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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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Calibration Procedural Summary

Step 1. Read appropriate overview


Choices Auto-Cal Calibration Manual Calibration Mode to Mode Calibration

2. Complete Pre-Calibration Procedures 3. Open Mode Calibration Procedures

Pre-Calibration Procedures Checklist Choose ONE:


Auto-Cal Using Commercial Calibrator Auto-Cal Using Fresh Whole Blood* Manual Calibration*

4. Closed Mode Calibration Procedures

Choose ONE:

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 Procedures


*

Complete both Quality Control and 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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Calibration Menu

Calibration Menu
Calibration Menu Flowchart
CALIBRATION Ready

ENTER FACTOR

CALIBRATN LOG

AUTOCALIBRATE

CLOSED SAMPLER OPEN SAMPLER

PRINT

MAIN

RESTORE FACTORS

RESET ALL TO 1.000

RETURN WHOLE BLOOD CALIBRATR MPV LATEX CHANGE SAMPLER (CS MODEL ONLY) RETURN

CLOSED SAMPLER OPEN SAMPLER

PRINT LOG

RETURN

EDIT REF VAL

START AUTO-CAL

CONTINUE AUTO-CAL

QUIT AUTO-CAL

CLEAR REF VALS

PRINT SUMMARY

RETURN

CONFIRM CLEAR

CANCEL CLEAR

CONFIRM QUIT

CANCEL QUIT

EDIT REF VAL

START AUTO-CAL

CONTINUE QUIT AUTO-CAL AUTO-CAL

CLEAR REF VALS

PRINT SUMMARY

RETURN

PREVIOUS SPECIMEN

NEXT SPECIMEN

REPEAT SPECIMEN

INTERRUPT QUIT AUTO-CAL AUTO-CAL CONTINUE AUTO-CAL

ACCEPT MEANS

PRINT

RETURN

CONFIRM REPEAT

CANCEL REPEAT CONFIRM QUIT

CONFIRM ACCEPT CANCEL QUIT

CANCEL ACCEPT

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Calibration Screen
CALIBRATION Ready Dec 20 1998 Operator ID Sequence # 16:01 rcs 0711

Open Sampler Open Sampler Calibration Factors: Parameter WOC WIC RBC HGB MCV PLT MPV Method ENTER FACTOR ENTER FACTOR ENTER FACTOR ENTER FACTOR ENTER FACTOR ENTER FACTOR FACTORY Factor 1.054 0.958 0.841 0.924 0.878 0.787 1.000 Date 12/20/98 12/20/98 12/20/98 12/20/98 12/20/98 12/20/98 --/--/-Time 14:15 14:15 14:15 14:15 14:15 14:15 --:-Operator rcs rcs rcs rcs rcs rcs ---

ENTER FACTOR

CALIBRATN LOG

AUTOCALIBRATE

CLOSED SAMPLER

PRINT

MAIN

Figure 6.1:
CALIBRATION

Calibration Screen Displaying Open Mode Calibration Factors

The CALIBRATION screen is accessed from the MAIN MENU screen by 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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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 Ready

Dec 20 1998 Operator ID Sequence #

16:01 rcs 0711

Open Sampler Closed Sampler Calibration Factors: Parameter WOC WIC RBC HGB MCV PLT MPV Method ENTER FACTOR ENTER FACTOR ENTER FACTOR ENTER FACTOR ENTER FACTOR ENTER FACTOR FACTORY Factor 1.054 0.958 0.841 0.924 0.878 0.787 1.000 Date 12/20/98 12/20/98 12/20/98 12/20/98 12/20/98 12/20/98 --/--/-Time 14:15 14:15 14:15 14:15 14:15 14:15 --:-Operator rcs rcs rcs rcs rcs rcs ---

ENTER FACTOR

CALIBRATN LOG

AUTOCALIBRATE

OPEN SAMPLER

PRINT

MAIN

Figure 6.2:

Calibration Menu Screen Displaying Closed Mode Calibration Factors

Open Sampler/Closed Sampler Soft Key


OPEN SAMPLER CLOSED SAMPLER

The [OPEN SAMPLER/CLOSED SAMPLER] key is used to display the current calibration factors for the mode selected (see the two preceding figures). 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 FACTOR

The [ENTER FACTOR] key is used to display the ENTER CALIBRATION 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 Ready

Dec 20 1998 Operator ID Sequence #

16:01 rcs 0711

Parameter WOC WIC RBC HGB MCV PLT MPV

(Factor Range) (0.701.30) (0.701.30) (0.801.20) (0.701.30) (0.701.30) (0.701.30) (0.701.30)

Open Sampler Factor 1.008 1.008 1.071 1.124 0.985 1.028 1.000

Closed Sampler Factor 1.056 1.056 1.060 1.136 0.985 0.939 1.000

RESTORE FACTORS

RESET ALL TO 1.000

RETURN

Figure 6.3:

Enter Calibration Factor Screen

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Calibration Menu

Restore Factors Soft Key


RESTORE FACTORS

The [RESTORE FACTORS] key is used to restore the previous calibration factors. This key is only active immediately after factors have been changed.

Reset All to 1.000 Soft Key


RESET ALL TO 1.000

The [RESET ALL TO 1.000] key is used to reset all of the calibration 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 Ready Dec 20 1998 Operator ID Sequence # 16:01 rcs 0711

Open Sampler Open Sampler Calibration Log Date 12/20/98 Comments: Time 14:15 OpID rcs WOC 1.05(E) WIC 0.96(E) RBC 0.84(E) HGB 0.92(E) MCV 0.88(E) PLT 0.79(E) MPV 1.00(F)

CLOSED SAMPLER

PRINT LOG

RETURN

Figure 6.4:
CALIBRATN LOG

Calibration Log Screen

The [CALIBRATN LOG] key is used to display the CALIBRATION 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 PRINT LOG RETURN (This key label alternates between these two selections.)

Open Sampler/Closed Sampler Soft Key


OPEN SAMPLER CLOSED SAMPLER

The [OPEN SAMPLER/CLOSED SAMPLER] key is used to display the calibration log for the selected mode. NOTE: The key is labeled for the sampler mode that is NOT currently displayed.

Print Log Soft Key


PRINT LOG

The [PRINT LOG] key is used to print the Calibration Log for the displayed mode.

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Calibration Menu

Return Soft Key


RETURN

The [RETURN] key is used to return to the CALIBRATION screen.

Auto-Calibrate Soft Key


AUTO-CALIBRATION Ready Dec 20 1998 Operator ID Sequence # 16:03 rcs 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 operators manual. To proceed, press the key for the specimen type being used (WHOLE BLOOD, CALIBRATR, or MPV LATEX).

WHOLE BLOOD

CALIBRATR

MPV LATEX

CHANGE SAMPLER

RETURN

Figure 6.5:
AUTOCALIBRATE

Auto-Calibration Screen for CELL-DYN 3700CS System

The [AUTO-CALIBRATE] key is used to access the Auto-Calibration 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 RETURN (This key is available on the CELL-DYN 3700CS System only.)

Change Sampler Soft Key


CHANGE SAMPLER

The [CHANGE SAMPLER] key is used to change the Sample Aspiration 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 Ready

Dec 20 1998 Operator ID Sequence #

16:01 rcs 0711

Open Sampler Enter reference value for each parameter to be calibrated: (up to 10 specimens) Spec ID Min Max CAL#01 CAL#02 RUNS 1 10 3 3 WOC 1.99 25.0 7.30 ---WIC 1.99 25.0 7.30 ---RBC 2.00 6.50 4.24 ---HGB 3.99 24.0 12.9 ---MCV 70.0 100. 90.0 ---PLT 50.0 600. 244. ----

EDIT REF VAL

START AUTO-CAL

QUIT AUTO-CAL

CLEAR REF VALS

PRINT SUMMARY

RETURN

Figure 6.6:
WHOLE BLOOD

Whole Blood Auto-Cal Screen

The [WHOLE BLOOD] key is used to display the WHOLE BLOOD AUTOCAL 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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Calibration Menu

Edit Reference Value Soft Key


EDIT REF VAL

The [EDIT REF VAL] key is used to edit the displayed reference value 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 REF VALS

The [CLEAR REF VALS] key is used to delete the reference values 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 SUMMARY

The [PRINT SUMMARY] key is used to print the entered reference values.

Return Soft Key


RETURN

The [RETURN] key is used to return to the AUTO-CALIBRATION screen.

Start Auto-Cal Soft Key


START AUTO-CAL

The [START AUTO-CAL] key starts the Auto-Cal program by initiating three background counts.

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Continue Auto-Cal Soft Key

WHOLE BLOOD AUTO-CAL Ready for calibration

Dec 20 1998 Operator ID Sequence #

16:01 rcs 0711

Open Sampler Enter reference value for each parameter to be calibrated: (up to 10 specimens) Spec ID Min Max CAL#01 CAL#02 RUNS 1 10 3 3 WOC 1.99 25.0 7.30 ---WIC 1.99 25.0 7.30 ---RBC 2.00 6.50 4.24 ---HGB 3.99 24.0 12.9 ---MCV 70.0 100. 90.0 ---PLT 50.0 600. 244. ----

EDIT REF VAL

CONTINUE AUTO-CAL

QUIT AUTO-CAL

CLEAR REF VALS

PRINT SUMMARY

RETURN

Figure 6.7:
CONTINUE AUTO-CAL INTERRUPT AUTO-CAL

Whole Blood Auto-Cal Screen

The [CONTINUE AUTO-CAL] key is displayed after the background counts are completed. (See the preceding figure.) 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 NO OF RUNS 331

WHOLE BLOOD AUTO-CAL Ready for Calibration

Dec 20 1998 Operator ID Sequence #

16:01 rcs 0711

Open Sampler RESULTS FOR SPECIMEN #1 Spec 1 RUN1 Factor ------------------------------------Mean Factor(1) ------------------Factor %Diff -------------------

Parameter WOC WIC RBC HGB MCV PLT

Value 7.30 7.30 4.24 12.9 90.0 244.

INTERRUPT AUTO-CAL

QUIT AUTO-CAL

PRINT

RETURN

Figure 6.8:
INTERRUPT AUTO-CAL CONTINUE AUTO-CAL

Whole Blood Auto-Cal Results Screen

The [INTERRUPT AUTO-CAL] key is used to interrupt (pause) the Auto-Cal program. Quit Auto-Cal Soft Key The [QUIT AUTO-CAL] key is used to exit from the 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 The [PRINT] key is used to print the WHOLE BLOOD AUTO-CAL RESULTS screen.

QUIT AUTO-CAL

PRINT

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RETURN

Return Soft Key The [RETURN] key is used to return to the REFERENCE VALUE ENTRY screen. Repeat Specimen Soft Key

SPEC ID CAL#01-01 NO. OF RUNS 3

WHOLE BLOOD AUTO-CAL Ready for Calibration

Dec 20 1998 Operator ID Sequence #

16:01 rcs 0711

Open Sampler RESULTS FOR SPECIMEN #1 Parameter WOC WIC RBC HGB MCV PLT Value 7.30 7.30 4.24 12.9 90.0 244. RUN1 7.42 7.42 4.39 13.0 91.0 254. RUN2 RUN3 ------------------------------------Spec 1 Factor 0.980 0.980 0.970 0.990 0.990 0.960 Mean Factor(1) ------------------Factor %Diff -------------------

REPEAT SPECIMEN

INTERRUPT AUTO-CAL

QUIT AUTO-CAL

PRINT

RETURN

Figure 6.9:
REPEAT SPECIMEN

Whole Blood Auto-Cal Results Screen with Results

The [REPEAT SPECIMEN] key is displayed when the first run of the 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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Calibrator Soft Key

CALIBRATOR AUTO-CAL Ready

Dec 20 1998 Operator ID Sequence #

16:01 rcs 0711

Open Sampler Enter reference value for each parameter to be calibrated: (up to 10 specimens) Spec ID Min Max CAL#01 CAL#02 Runs 1 10 3 3 WOC 4.59 10.2 7.30 ---WIC 4.59 10.2 7.30 ---RBC 3.00 5.50 4.46 ---HGB 10.0 15.5 13.2 ---MCV 85.0 97.0 85.4 ---PLT 150. 400. 257. ---MPV 4.99 20.0 8.00

EDIT REF VAL

START AUTO-CAL

QUIT AUTO-CAL

CLEAR REF VALS

PRINT SUMMARY

RETURN

Figure 6.10:
CALIBRATR

Calibrator Auto-Cal Screen

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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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 Ready

Dec 20 1998 Operator ID Sequence #

16:01 rcs 0711

Open Sampler Enter latex reference value for MPV: (up to 10 specimens) Spec ID Min Max CAL#01 CAL#02 RUNS 1 10 3 3 MPV 4.99 20.0 7.30 ----

EDIT REF VAL

START AUTO-CAL

QUIT AUTO-CAL

CLEAR REF VALS

PRINT SUMMARY

RETURN

Figure 6.11:
MPV LATEX

Latex Auto-Cal Screen

The [MPV LATEX] key is used to display the MPV LATEX AUTO-CAL screen (see the preceding figure).

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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 manufacturers 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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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: WIC/HGB Lyse: Sheath Reagent: Detergent: Lot #____________ Lot #____________ Lot #____________ Lot #____________ Exp. date _______ Exp. date _______ Exp. date _______ 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 WOC RBC HGB PLT <0.3 <0.3 <0.03 <0.2 <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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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 WIC WOC RBC HGB MCV PLT 11.______ CV% LIMIT <2.8% <2.5% <1.5% <1.2% <1.0% <5.0% CV ________ ________ ________ ________ ________ ________

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 WIC WOC RBC HGB MCV PLT CV% LIMIT <2.8% <2.5% <1.5% <1.2% <1.0% <5.0% CV ________ ________ ________ ________ ________ ________

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 WIC WOC RBC HGB MCV PLT CV% LIMIT <2.8% <2.5% <1.5% <1.2% <1.0% <5.0% CV ________ ________ ________ ________ ________ ________

12.______ If any problems are detected during the procedures outlined above, document them on the following page.

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Problems Detected
_______________________________________________________________________________________________ _______________________________________________________________________________________________ _______________________________________________________________________________________________ _______________________________________________________________________________________________ _______________________________________________________________________________________________ _______________________________________________________________________________________________ _______________________________________________________________________________________________ _______________________________________________________________________________________________ _______________________________________________________________________________________________ _______________________________________________________________________________________________ _______________________________________________________________________________________________ _______________________________________________________________________________________________ _______________________________________________________________________________________________ _______________________________________________________________________________________________ _______________________________________________________________________________________________ _______________________________________________________________________________________________ _______________________________________________________________________________________________ _______________________________________________________________________________________________ _______________________________________________________________________________________________ _______________________________________________________________________________________________ _______________________________________________________________________________________________ _______________________________________________________________________________________________ _______________________________________________________________________________________________ _______________________________________________________________________________________________ _______________________________________________________________________________________________ _______________________________________________________________________________________________ _______________________________________________________________________________________________ _______________________________________________________________________________________________ _______________________________________________________________________________________________ _______________________________________________________________________________________________ _______________________________________________________________________________________________

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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 Limit Calibration Range Calibration not required Do not calibrate, possible instrument problem exists 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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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 Type Whole Blood Commercial Calibrator Specimen Limit 10 10 Maximum Number of Consecutive Runs Open 10 10 Closed (Closed Sampler only) 5 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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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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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 AUTOCALIBRATION 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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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 24 of Entering the Reference Values is retained.
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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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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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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 (Cal Not Required) WOC WIC RBC HGB MCV PLT <1.5% <1.5% <1.0% <1.0% <1.0% <3.0% Calibration Range (Cal Required) >1.5% but <10% >1.5% but <10% >1.0% but <10% >1.0% but <10% >1.0% but <10% >3.0% but <15% Calibration Limit (Do Not Cal) >10% >10% >10% >10% >10% >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 RBC HGB MCV PLT <1.5% <1.0% <1.0% <1.0% <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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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 HGB MCV PLT >10% >10% >10% >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 WOC Flow Cell WIC Transducer WIC Aperture Plate RBC/PLT Transducer RBC/PLT Aperture Plate Hemoglobin Flow Cell 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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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 RBC HGB MCV PLT >1.5% >1.0% >1.0% >1.0% >3.0% but < 10% but < 10% but < 10% but < 10% 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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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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CELL-DYN 3700 System Auto-Cal Calibration Criteria Worksheet


Instrument: ___________________________________ Operator: _____________________________________ ____________________________________________________________________________________________ Auto-Cal Calibration Criteria Factor %Diff* WOC WIC RBC HGB MCV PLT Validation Range (Cal Not Required) <1.5% <1.5% <1.0% <1.0% <1.0% <3.0% Calibration Range (Cal Required) >1.5% but <10% >1.5% but <10% >1.0% but <10% >1.0% but <10% >1.0% but <10% >3.0% but <15% Calibration Limit (Do Not Cal**) >10% >10% >10% >10% >10% >15% Cal? Y/N Date: _______________________________________

* 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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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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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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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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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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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 Cal Not Required WOC WIC RBC HGB MCV PLT <1.5% <1.5% <1.0% <1.0% <1.0% <3.0% Calibration Range Cal Required >1.5% but <10% >1.5% but <10% >1.0% but <10% >1.0% but <10% >1.0% but <10% >3.0% but <15% Calibration Limit Do Not Cal >10% >10% >10% >10% >10% >15%

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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 RBC HGB MCV PLT <1.5% <1.0% <1.0% <1.0% <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 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 RBC HGB MCV PLT >10% >10% >10% >10% >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 WOC Flow Cell WIC Transducer WIC Aperture Plate RBC/PLT Transducer RBC/PLT Aperture Plate Hemoglobin Flow Cell 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 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 RBC HGB MCV PLT >1.5% >1.0% >1.0% >1.0% >3.0% but <10% but <10% but <10% but <10% 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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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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Auto-Cal Calibration Criteria Worksheet
Instrument: ___________________________________ Operator: _____________________________________ ____________________________________________________________________________________________ Date: _______________________________________

Auto-Cal Calibration Criteria


Factor %Diff* WOC WIC RBC HGB MCV PLT Validation Range (Cal Not Required) <1.5% <1.5% <1.0% <1.0% <1.0% <3.0% Calibration Range (Cal Required) >1.5% but <10% >1.5% but <10% >1.0% but <10% >1.0% but <10% >1.0% but <10% >3.0% but <15% Calibration Limit (Do Not Cal**) >10% >10% >10% >10% >10% >15% Cal? Y/N

* 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).

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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 Limit Calibration Range Calibration not required Do not calibrate, possible instrument problem exists 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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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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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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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 CELL-DYN Mean x Current Open Mode = New Open Mode Cal Factor Cal Factor

Reference Whole Blood Calibration:


Reference Mean CELL-DYN Mean x Current Open Mode = New Open Mode 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 Current Open Mode Cal Factor

x 100 = Factor % Difference

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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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 (Cal Not Required) WOC WIC RBC HGB MCV PLT <1.5% <1.5% <1.0% <1.0% <1.0% <3.0% Calibration Range (Cal Required) >1.5% but <10% >1.5% but <10% >1.0% but <10% >1.0% but <10% >1.0% but <10% >3.0% but <15% Calibration Limit (Do Not Cal) >10% >10% >10% >10% >10% >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 RBC HGB MCV PLT <1.5% <1.0% <1.0% <1.0% <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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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 RBC HGB MCV PLT >10% >10% >10% >10% >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 WOC Flow Cell WIC Transducer WIC Aperture Plate RBC/PLT Transducer RBC/PLT Aperture Plate Hemoglobin Flow Cell 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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Results within the Calibration Range: WIC/WOC >1.5% RBC HGB MCV PLT >1.0% >1.0% >1.0% >3.0% but but but but but <10% <10% <10% <10% <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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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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Manual Calibration Worksheet
Instrument: ___________________________________ Operator: _____________________________________ ____________________________________________________________________________________________ Calculate All Factors To Three Decimal Places Date: _______________________________________

New Open Mode Calibration Factors


Assay or Ref Mean CELL-DYN Mean Assay Value or Ref Mean WOC WIC RBC HGB MCV PLT x Current Open Mode Cal Factor* = New Open Mode Cal Factor

/ / / / / / /

Open Mode Mean

x x x x x x x

Current Open Mode Cal Factor*

= = = = = = =

New Open Mode Cal Factor

Range** 0.7001.300 0.7001.300 0.8001.200 0.7001.300 0.7001.300 0.7001.300

* 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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Factor % Difference
New Open Mode Factor Current Open Mode Factor x 100 = % Diff Current Open Mode Factor New Open Mode Factor WOC WIC RBC HGB MCV PLT Current Open Mode Factor* Current Open Mode Factor

/ / / / / / /

x 100 = x 100 = x 100 = x 100 = x 100 = x 100 = x 100 =

% Diff

* The Current Open Mode Factor is printed at the start of this calibration procedure.

Manual Calibration Criteria


Factor %Diff* WOC WIC RBC HGB MCV PLT Validation Range (Cal Not Required) <1.5% <1.5% <1.0% <1.0% <1.0% <3.0% Calibration Range (Cal Required) >1.5% but <10% >1.5% but <10% >1.0% but <10% >1.0% but <10% >1.0% but <10% >3.0% but <15% Calibration Limit (Do Not Cal**) >10% >10% >10% >10% >10% >15% Cal? Y/N

* 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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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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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 laboratorys 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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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 AUTOCALIBRATION 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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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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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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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 Cal Not Required WOC WIC RBC HGB MCV PLT <1.75% <1.75% <1.25% <1.25% <1.25% <3.50% Calibration Range Cal Required >1.75% but <10% >1.75% but <10% >1.25% but <10% >1.25% but <10% >1.25% but <10% >3.50% but <20% Calibration Limit Do Not Cal >10% >10% >10% >10% >10% >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 RBC HGB MCV PLT <1.75% <1.25% <1.25% <1.25% <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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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 RBC HGB MCV PLT >10% >10% >10% >10% >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 WOC Flow Cell WIC Transducer WIC Aperture Plate RBC/PLT Transducer RBC/PLT Aperture Plate Hemoglobin Flow Cell 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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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 RBC HGB MCV PLT >1.75% >1.25% >1.25% >1.25% >3.50% but but but but but <10% <10% <10% <10% <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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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 RBC HGB MCV PLT <1.75% <1.25% <1.25% <1.25% <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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CELL-DYN 3700 System Mode to Mode Auto-Cal Calibration Criteria Worksheet


Instrument: ___________________________________ Operator: _____________________________________ ____________________________________________________________________________________________ Mode to Mode Auto-Cal Calibration Criteria Factor %Diff* WOC WIC RBC HGB MCV PLT Validation Range (Cal Not Required) <1.75% <1.75% <1.25% <1.25% <1.25% <3.50% Calibration Range (Cal Required) >1.75% but <10% >1.75% but <10% >1.25% but <10% >1.25% but <10% >1.25% but <10% >3.50% but <20% Calibration Limit (Do Not Cal**) >10% >10% >10% >10% >10% >20% Cal? Y/N Date: _______________________________________

* 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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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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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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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 Open Mode Mean x 100 = % Difference

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 Cal Not Required WOC WIC RBC HGB MCV PLT <1.75% <1.75% <1.25% <1.25% <1.25% <3.50% Calibration Range Cal Required >1.75% but <10% >1.75% but <10% >1.25% but <10% >1.25% but <10% >1.25% but <10% >3.50% but <20% Calibration Limit Do Not Cal >10% >10% >10% >10% >10% >20%

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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 RBC HGB MCV PLT <1.75% <1.25% <1.25% <1.25% <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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Results greater than the Calibration Limit: WIC/WOC RBC HGB MCV PLT >10% >10% >10% >10% >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 WOC Flow Cell WIC Transducer WIC Aperture Plate RBC/PLT Transducer RBC/PLT Aperture Plate Hemoglobin Flow Cell 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 RBC HGB MCV PLT >1.75% but >1.25% but >1.25% but >1.25% but >3.50% but <10% <10% <10% <10% <20%

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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 Closed Mode Mean x Current Closed Mode Cal Factor = New Closed Factor

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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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 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 RBC HGB MCV PLT <1.75% <1.25% <1.25% <1.25% <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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CELL-DYN 3700 System Manual Mode to Mode Calibration Worksheet


Instrument: ___________________________________ Operator: _____________________________________ ____________________________________________________________________________________________ Calculate All Factors To Three Decimal Places Date: _______________________________________

Mode to Mode Calibration Difference


Closed Mode Mean - Open Mode Mean Open Mode Mean Closed Mode Mean WOC WIC RBC HGB MCV PLT Open Mode Mean x 100 = % Diff

/ / / / / / /

Open Mode Mean

x 100 = x 100 = x 100 = x 100 = x 100 = x 100 = x 100 =

% Diff

Mode to Mode Calibration Criteria


%Diff* WOC WIC RBC HGB MCV PLT Validation Range (Cal Not Required) <1.75% <1.75% <1.25% <1.25% <1.25% <3.50% Calibration Range (Cal Required) >1.75% but <10% >1.75% but <10% >1.25% but <10% >1.25% but <10% >1.25% but <10% >3.50% but <20% Calibration Limit (Do Not Cal**) >10% >10% >10% >10% >10% >20% Cal? Y/N

* 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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New Closed Mode Calibration Factors


Open Mode Mean Closed Mode Mean x Current Closed Mode Cal Factor* = New Closed Mode Cal Factor

Open Mode Mean WOC WIC RBC HGB MCV PLT

/ / / / / / /

Closed Mode Mean

x x x x x x x

Current Closed Mode Cal Factor*

= = = = = = =

New Closed Mode Cal Factor

Range** 0.7001.300 0.7001.300 0.8001.200 0.7001.300 0.7001.300 0.7001.300

* 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 Open Mode Mean Closed Mode Mean* WOC WIC RBC HGB MCV PLT Open Mode Mean Open Mode Mean x 100 = % Difference

/ / / / / / /

x 100 = x 100 = x 100 = x 100 = x 100 = x 100 = x 100 =

% Diff

Range** <1.75% <1.75% <1.25% <1.25% <1.25% <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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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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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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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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NOTES

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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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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. A multi-rule system is applied to the data in each of the QC files. Bulls Moving Average Program is applied to the RBC Indices and a similar moving average calculation is applied to some WBC Differential optical parameters.

Westgard Rules X-B Analysis

The options may be used independently or in combination at the operators 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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Quality Control Menu Flowchart


QC MENU Ready

X-B SET UP

X-B FILE

VIEW QC LOG

QC LIMITS

SET UP QC FILE

CUSTOMIZE CUSTOMIZE PRINTOUT DISPLAY

MAIN

TURN ON TURN ON X-B WBC X-B RBC TURN OFF TURN OFF X-B WBC X-B RBC

PRINT

RETURN

CANCEL STANDARD SELECT PARAMETER SELECTION SELECTION PLACE PARAMETER

RETURN

X-B RBC GRAPHS X-B RBC DATA

X-B WBC GRAPHS X-B WBC DATA

PRINT

RETURN

CANCEL SELECT PARAMETER SELECTION PLACE PARAMETER

STANDARD GROUPS CUSTOM PLACEMENT

TOGGLE ONE/ALL

RETURN

WBC GROUP LOT NUMBER REPLICATE ID RANGE ENTRY MEANS/ LIMITS WRITE QC TO DISK TOGGLE ON/OFF

RBC GROUP PRINT

PLT GROUP RETURN

DIFF GROUP

CUSTOMIZE RETURN PRINTOUT

UPDATE FROM FILE

LOAD FROM DISK

PRINT

RETURN

PURGE QC LOG

LEVEYJENNINGS

REJECT SPECIMEN ACCEPT SPECIMEN

DELETE SPECIMEN

MOVE SPECIMEN

PRINT QC LOG

RETURN

LOAD LOW

LOAD NORMAL

LOAD HIGH

RETURN

CONFIRM PURGE

CANCEL PURGE

CONFIRM UPDATE CONFIRM CANCEL DELETION DELETION MOVE TO FILE CANCEL MOVE

CANCEL UPDATE

GROUP 1

GROUP 2

GROUP 3

GROUP 4

PRINT

RETURN

WRITE LOW

WRITE NORMAL

WRITE HIGH

RETURN

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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 Ready

Nov 20 1998 Operator ID Sequence #

16:01 rcs 0711

File Name 1. Low 2. Normal 3. High 4. FILE 4 5. FILE 5 6. FILE 6 7. FILE 7 8. FILE 8 9. FILE 9 10. FILE 10

# Specimens 11 13 0 0 0 0 0 0 0 0

File Name 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. Patient FILE 12 FILE 13 FILE 14 FILE 15 FILE 16 FILE 17 FILE 18 FILE 19 FILE 20

# Specimens 30 0 0 0 0 0 0 0 0 0

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

X-B SET UP

X-B FILE

VIEW QC LOG

QC LIMITS

SET UP QC FILE

CUSTOMIZE DISPLAY

CUSTOMIZE PRINTOUT

MAIN

Figure 7.1:
QUALITY CONTROL

QC Menu Screen

The following soft key labels are displayed on the QC MENU screen: 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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X-B File Soft Key


X-B FILE

The following soft key labels are displayed when the [X-B FILE] key is pressed: X-B RBC DATA or X-B RBC GRAPHS X-B WBC DATA or X-B WBC GRAPHS PRINT RETURN (The key label alternates between these two selections.) (The key label alternates between these two selections.)

X-B RBC Data Soft Key


X-B FILE DISPLAY Standby PAGE UP/DN FOR MORE DATA X-B RBC DATA BATCH 1 2 3 4 5 6 7 8 9 10 Upper Lower MCV 90.10 90.51 90.50 89.47 89.72 89.71 89.57 89.93 91.61 91.83 92.39 87.01 MCH 30.19 30.54 30.43 30.11 30.26 30.24 30.11 30.11 30.63 30.80 31.21 29.39 MCHC 33.52 33.56 33.52 33.50 33.56 33.56 33.54 33.45 33.45 33.52 34.71 32.69 DATE 12/10/98 12/10/98 12/10/98 12/11/98 12/11/98 12/11/98 12/11/98 12/11/98 12/11/98 12/11/98 TIME 14:42 17:21 21:05 04:07 06:02 07:26 08:24 09:29 11:05 11:54

Dec 12 1998 Operator ID Sequence #

11:47 abc 1491

X-B RBC GRAPHS

X-B WBC GRAPHS

PRINT

RETURN

Figure 7.2:
X-B RBC DATA X-B RBC GRAPHS

The X-B RBC Data Screen

The [X-B RBC DATA] key is used to display the X-B data for RBC indices on the X-B FILE DISPLAY screen. (See the preceding figure.) This screen displays the results for X-B batches 110 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 1120. When batches 1120 are displayed, the Page Up key on the keyboard is used to display batches 110. NOTE: The X-B RBC data can also be viewed as graphs by pressing the [X-B RBC GRAPHS] key.

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X-B RBC Graphs Soft Key


X-B RBC GRAPHS X-B RBC DATA

The [X-B RBC GRAPHS] key is used to display the X-B graphs for RBC indices on the X-B FILE DISPLAY screen. (See the following figure.) This screen displays the results for X-B batches 120 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 Standby X-B RBC GRAPHS

Dec 12 1998 Operator ID Sequence #

11:47 abc 1491

MCV 92.39 89.70 87.01 31.21 30.30 29.39

MCH 34.71 33.70 32.69

MCHC

X-B RBC DATA

X-B WBC GRAPHS

PRINT

RETURN

Figure 7.3:

The X-B RBC Graphs Screen

X-B WBC Data Soft Key


X-B WBC DATA X-B WBC GRAPHS

The [X-B WBC DATA] key is used to display the X-B data for WBC differential optical parameters on the X-B FILE DISPLAY screen. (See the following figure.) This screen displays the results for X-B batches 110 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 1120. When batches 1120 are displayed, the Page Up key on the keyboard is used to display batches 110. NOTE: The X-B WBC data can also be viewed as graphs by pressing the [X-B WBC GRAPHS] key.

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X-B FILE DISPLAY Standby PAGE UP/DN FOR MORE DATA X-B WBC DATA BATCH 1 2 3 4 5 6 7 8 9 10 Upper Lower L0D 62 62 62 62 62 62 62 62 64 63 74 50 L10D 64 63 64 62 68 63 63 63 63 62 73 49 N0D 151 151 152 152 151 150 152 154 159 155 176 118 N10D 142 142 144 135 130 136 146 147 149 147 168 112 N90D 111 114 117 117 116 115 115 116 120 119 137 91 N90DEP 17 18 18 18 18 18 17 17 18 18 20 14

Dec 12 1998 Operator ID Sequence #

11:47 abc 1491

NEU-EO 21.2 21.4 21.2 21.1 20.7 20.7 20.4 20.4 20.4 20.4 27.3 14.7

DATE 12/10/98 12/10/98 12/10/98 12/11/98 12/11/98 12/11/98 12/11/98 12/11/98 12/11/98 12/11/98

TIME 14:42 17:21 21:05 04:07 06:02 07:26 08:24 09:29 11:05 11:54

X-B RBC GRAPHS

X-B WBC GRAPHS

PRINT

RETURN

Figure 7.4:

The X-B WBC Data Screen

X-B WBC Graphs Soft Key


X-B WBC GRAPHS X-B WBC DATA

The [X-B WBC GRAPHS] key is used to display the X-B graphs for WBC differential optical parameters on the X-B FILE DISPLAY screen. (See the following figure.) This screen displays the results for X-B batches 120 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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X-B FILE DISPLAY Standby X-B WBC GRAPHS L0D 74 62 50 73 61 49 L10D

Dec 12 1998 Operator ID Sequence # N0D 176 147 118

11:47 abc 1491

N10D 168 140 112 137 114 91

N90D 20 17 14

N90DEP

NEU-EO 27.3 21.0 14.7

X-B RBC GRAPHS

X-B WBC DATA

PRINT

RETURN

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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View QC Log Soft Key


1
Lot Number: N0041 Exp. Date: 12/06/98 Norm 41 OPEN: 29/120 Page 4 of 4 Upper Limits: Lower Limits: Target Mean: Seq 6627 6628 8.60 7.40 8.00 WBC 8.12 7.80 8.60 7.40 8.00 WOC 8.12 7.80

VIEW QC LOG Ready USE < OR > FOR MORE DATA

Nov 26 1998 Operator ID Sequence #

10:46 732 6632

8.60 7.40 8.00 WIC 7.96 7.68

4.51 4.15 4.33 RBC 4.32 4.32

13.6 12.8 13.2 HGB 13.3 13.3

91.7 85.7 88.7 MCV 89.5 98.7

270. 220. 245. PLT 225. 231.

5
O O

Date 11/20/98 11/20/98

Time 10:10 10:12

Op 732 732

WBC

WOC 27 8.03 .110 1.4

WIC 27 7.76 .150 1.9

RBC 27 4.31 .055 1.3

HGB 27 13.3 .101 0.8

MCV 27 89.7 .465 0.5

PLT 27 235. 7.27 3.1 WRITE QC TO DISK PRINT QC LOG RETURN

N: File Mean: Std Dev: CV (./.): PURGE QC LOG LEVEYJENNINGS

27 8.03 .110 1.4

REJECT SPECIMEN

DELETE SPECIMEN

MOVE SPECIMEN

Figure 7.6:
VIEW QC LOG

The View QC Log Screen

The [VIEW QC LOG] key is used to display the QC Log indicated by 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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Quality Control Menu

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: FILE MEAN: STD DEV: CV (%): The number of runs used in the calculation The mean value for the number of runs used in the calculation The standard deviation for the number of runs used in the calculation 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 DELETE SPECIMEN MOVE SPECIMEN WRITE QC TO DISK PRINT QC LOG RETURN (This key label alternates between these two selections.)

Purge QC Log Soft Key


PURGE QC LOG

The [PURGE QC LOG] key is used to delete the contents of the QC 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 Seq num: 5597 to 6628 WBC: 8.60 8.00 7.40 RBC: 4.51 4.33 4.15 PLT: 270. 245. 220. 13.6 13.2 12.8 8.60 8.00 7.40

LEVEY-JENNINGS MENU Ready WOC:

Nov 26 1998 Operator ID Sequence # WIC: 8.60 8.00 7.40

10:46 732 6632

HGB: 91.7 88.7 85.7

MCV:

GROUP 2

GROUP 3

GROUP 4

PRINT

RETURN

Figure 7.7:
LEVEYJENNINGS

The Levey-Jennings Menu Screen

The [LEVEY-JENNINGS] key accesses the LEVEY-JENNINGS MENU 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 1 4

Each of these keys is used to select the graphs for a group of data 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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PRINT

The [PRINT] key is used to print the Levey-Jennings graphs. When the [PRINT] key is pressed, all of the graphs are automatically printed. The [RETURN] key is used to return to the VIEW QC LOG screen.

RETURN

Reject Specimen/Accept Specimen Soft Key

Lot Number: N0041 Exp. Date: 12/06/98 Norm 41 OPEN: 29/120 Page 4 of 4 Upper Limits: Lower Limits: Target Mean: Seq 6627 6628 R 8.60 7.40 8.00 WBC 8.12 7.80 8.60 7.40 8.00 WOC 8.12 7.80

V IEW QC LOG Ready USE < OR > FOR MORE DATA

Nov 26 1998 Operator ID Sequence #

10:48 732 6632

8.60 7.40 8.00 WIC 7.96 7.68

4.51 4.15 4.33 RBC 4.32 4.32

13.6 12.8 13.2 HGB 13.3 13.3

91.7 85.7 88.7 MCV 89.5 89.7

270. 220. 245. PLT 225. 231. O O Date 11/20/98 11/20/98 Time 10:10 10:12 Op 732 732

WBC N: File Mean: Std Dev: CV (./.): PURGE QC LOG LEVEYJENNINGS 26 8.02 .111 1.4

WOC 26 8.02 .111 1.4

WIC 26 7.75 .147 1.9

RBC 26 4.31 .056 1.3

HGB 26 13.3 .103 0.8

MCV 26 89.7 .471 0.5

PLT 26 236. 7.14 3.0 WRITE QC TO DISK PRINT QC LOG RETURN

ACCEPT SPECIMEN

DELETE SPECIMEN

MOVE SPECIMEN

Figure 7.8:
REJECT SPECIMEN ACCEPT SPECIMEN

QC Log Screen With Rejected Results

The [REJECT SPECIMEN] key is used to exclude the results for the specimen indicated by the cursor position. When the key is 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 SPECIMEN

The [DELETE SPECIMEN] key is used to delete the results for the 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 SPECIMEN

The [MOVE SPECIMEN] key is used to move the QC result indicated 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 TO DISK

The [WRITE QC TO DISK] key enables the download of data from a 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 QC LOG

The [PRINT QC LOG] key is used to print the entire QC Log.

Return Soft Key


RETURN

The [RETURN] key is used to return to the QC MENU screen.

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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 laboratorys 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 laboratorys 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:

Average SD =

(N1 (N2 . (Ni 2 (Ni (N1 12+2 x SD2SD x SD1 22))+. SDi2) SD 2) (N 2 ... )+ SD + . x ) (N1...Ni) -- 1 N2 1 . . (N+ 2+Ni) 1+N + .

N SD i

= = =

number of values in a group Standard Deviation of the values in that group the last group of values

The resultant long-term instrument SD and the laboratoryestablished 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 (Westgards nomenclature is given in parentheses) available on the System Software are: Rule 1 (13s): Rule 2 (22s): Value outside 3SD A control result exceeded the mean 3SD. Two consecutive values outside the same 2SD Two consecutive results fell outside 2SD on the same side of the mean. 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 3 (R4s):

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. Ten consecutive values on the same side of mean Ten consecutive results fell on the same side of the mean.

Rule 6 (10x):

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 Seq num: 14 to 42 WBC:+-+-+6 4.80 4.40 4.40 RBC:+-+-++ 5.14 4.90 4.66 PLT:+-+-++ 248. 226. 204. 16.0 15.3 14.6 4.80 4.40 4.40

LEVEY-JENNINGS MENU Ready WOC:+-+-+6

Dec 15 1998 Operator ID Sequence #

15:06 sh 0630 WIC:+-+-+6

4.80 4.40 4.40 HGB:+-+-+6 104. 99.3 94.4 MCV:+-+-++

GROUP 2

GROUP 3

GROUP 4

PRINT

RETURN

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. 190192), 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. Bulls 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. Bulls 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. Bulls earlier studies) displayed on the X-B SET UP screen or by entering the values from Dr. Bulls 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 interrelationships 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 X-B Pattern MCV will be MCH will be MCHC will be is increased High N/A Low is decreased Low N/A High

If the RBC is increased N/A Low Low is decreased N/A High High

If the HGB is increased N/A High High is Index decreased Derivation N/A Low Low MCV HGB/RBC HGB/HCT

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 instruments 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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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 LYM 0 LYM 10 NEU 0 NEU 10 NEU 90 NEU 90 DEP NEU-EOS

Acceptance Limits 48 - 70 51 - 67 141 - 179 128 - 170 87 - 163 11 - 31 14 - 32

Target Mean 59 59 160 149 125 21 23

Action Limit 7 5 4 5 10 19 13

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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 nonrandom 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.

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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; 27:3:493501. 3. Cembrowski GS, et al. Use of a Multirule Control Chart for the Quality Control of PT and APTT Analyses. Laboratory Medicine June 1989; 418421. 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), 121150. 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: 604606. 8. Chanarin I, ed. Laboratory Hematology: An Account of Laboratory Techniques. New York: Churchill Livingstone. 3-7. 1989.

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NOTES

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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 Operators 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 Operators 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: WARNING: CAUTION: Denotes an immediate hazard which, if not avoided, could result in serious injury or death. Denotes a hazard which, if not avoided, could result in moderate to serious injury. 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. Denotes special operator/service information or standard practices.

NOTE:

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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.

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Hazards 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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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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Hazards 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, nonconductive 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.

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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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Hazards 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 loaders 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.

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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 Protective Cover Laser Warning Label

Figure 8.2:

Laser Aperture and Warning Label Position Protective Cover

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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:


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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 instruments 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

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Hazards 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.

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NOTES

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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.

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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.
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Figure 9.1:
Grounding Wire Clip WOC Mixing Chamber A.C.C. Interlock Switch Grounding Wire Clip Sample Aspiration Peristaltic Pump Mounting Bracket WOC Flow Cell Cover Mounting Bracket Optical Bench Assembly

Mounting Bracket

Overflow Chamber

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Shear Valve Assembly Normally Closed Valves Wash Block Open Sample Aspiration Probe Touch Plate WOC Metering Syringe (contains Sheath Reagent) HGB/WIC Lyse Syringe (contains HGB/WIC Lyse) WOC Sheath Syringe (contains Sheath Reagent) RBC/PLT Diluent Syringe (contains Diluent) HGB/WIC Diluent Syringe (contains Diluent) Waste Chamber 2

Aerosol Filter

von Behrens WIC Transducer Assembly

Analyzer Flow Panel Components

WOC Transfer Peristaltic Pump

HGB Flow Cell

WIC Metering Assembly

Mounting Bracket

von Behrens RBC/PLT Transducer Assembly

Waste Chamber 1

Maintenance

RBC/PLT Diluent Overpressure Sensor

Vacuum Accumulator Drain Line RBC/PLT Metering Assembly

Overview

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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 AutoClean 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 X= B-A 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: X= 5.25 - .5 .5 X = 9.5

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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Special Protocols Menu

Special Protocols Menu

SPECIAL PROTOCOLS Ready

Nov 20 1998 Operator ID Sequence #

16:01 rcs 0711

EMPTY XDUCERS

REAGENT RESERVOIR

EMPTY WOC

MAINTEN LOG

CLEAN SHEAR VAL

DISABLE ANALYZER

MORE

MAIN

Figure 9.2:
SPECIAL PROTOCOLS

Special Protocols Screen

The SPECIAL PROTOCOLS screen is accessed from the MAIN MENU screen by pressing the [SPECIAL PROTOCOLS] key. The following soft key labels are displayed: EMPTY XDUCERS or FILL XDUCERS 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 DISABLE ANALYZER or ENABLE ANALYZER MORE MAIN (The soft key label alternates between these two selections.) (The soft key label alternates between these two selections.) (The soft key label alternates between these two selections.)

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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 XDUCERS

The [EMPTY XDUCERS] key is used to empty both chambers in the 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]. When the [FILL XDUCERS] key is pressed, the transducers are refilled with reagent.

FILL XDUCERS

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Draining the Reagent Reservoirs


REAGENT RESERVOIR Ready Nov 20 1998 Operator ID Sequence # 16:01 rcs 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 DILUENT

EMPTY LYSE

EMPTY SHEATH

EMPTY DETERGENT

RETURN

Figure 9.3:
REAGENT RESERVOIR

Reagent Reservoir Screen

The [REAGENT RESERVOIR] key is used to drain the reagent reservoirs 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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Draining the Optical Flow Cell


EMPTY WOC

The [EMPTY WOC] key is used to drain the reagent from the 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 LOG

The [MAINTEN LOG] key is used to set up, review, and print the 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 The [INTERVAL SET UP] key is used to configure the maintenance schedule. The [UPDATE LOG] key is used to indicate when maintenance was performed and to add comments to the Maintenance Log. The [PRINT & PURGE] key is used to print the completed log and 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.

INTERVAL SET UP

UPDATE LOG

PRINT & PURGE

PRINT LOG

The [PRINT LOG] key is used to print the Maintenance Log. 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.

RETURN

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Accessing the Shear Valve


CLEAN SHEAR VAL

The [CLEAN SHEAR VAL] key is used to prepare the Shear Valve for 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]. When the [RESTORE SHEAR VAL] key is pressed, the syringes refill 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].

RESTORE SHEAR VAL

Disabling/Enabling the Analyzer


DISABLE ANALYZER

The [DISABLE ANALYZER] key is used to prevent the Analyzer from cycling while certain maintenance procedures are performed. When the Analyzer is disabled, the key label changes to [ENABLE ANALYZER]. When the [ENABLE ANALYZER] key is pressed, the Analyzer is returned to the READY state.

ENABLE ANALYZER

SPECIAL PROTOCOLS Ready

Nov 20 1998 Operator ID Sequence #

16:01 rcs 0711

FLUSH SHEATH

AUTO CLEAN

DAILY SHUTDOWN

PREPARE SHIPPING

CLEAN NEEDLE

EXTEND AUTOCLEAN

MORE

MAIN

Figure 9.4:

Special Protocols Screen 2

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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 SHEATH

The [FLUSH SHEATH] key is used to flush the WOC Flow Cell with Sheath Reagent. The [AUTO CLEAN] key is used to initiate the Auto-Clean Cycle. 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 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.

AUTO CLEAN

DAILY SHUTDOWN

The [DAILY SHUTDOWN] key is used to initiate the Daily 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. The [PREPARE SHIPPING] key is used to prepare the Analyzer for shipment or a period of inactivity. The cycle drains all of the reagents from the system and then rinses the fluidics with deionized water.

PREPARE SHIPPING

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Special Protocols Menu

CLEAN NEEDLE

The [CLEAN NEEDLE] key is used to clean the needles used in either of the Closed Modes (CS or SL) of operation. When this key is pressed, the needle is forcefully rinsed with diluent. The [EXTEND AUTOCLEAN] key is used to initiate the Extended AutoClean 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 AutoClean cycle.

EXTEND AUTO-CLEAN

MORE

The [MORE] key is used to return to the first SPECIAL PROTOCOLS screen.

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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 Ready

Nov 20 1998 Operator ID Sequence # PUMP TUBING ASPR WOC X EXT AUTO

16:01 rcs 0711

Date Time OpID 10/09/98 08:30 sh Comments: Weekly Maintenance 10/16/98 08:32 jg Comments: Weekly Maintenance 10/23/98 08:33 td Comments: Weekly Maintenance

SHEAR AIR VALVE FILTR X

SYNG

APERTURES WIC RBC

SL X

AUTO OTHER

INTERVAL SET UP

UPDATE LOG

PRINT & PURGE

PRINT LOG

RETURN

Figure 9.5:
MAINTEN LOG

Maintenance Log Screen

The MAINTENANCE LOG screen is accessed from the SPECIAL 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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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 Log Set Up

Interval Set Up Procedure


INTERVAL SET UP Ready Nov 09 1998 Operator ID Sequence # 12:24 sh 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 AIR FILTERS SYRINGES WIC APERTURE RBC APERTURE ASPIRATION PUMP TUBING WOC PUMP TUBING SAMPLE LOADER TRAY AND RACKS EXTENDED AUTO-CLEAN AUTO-CLEAN

7 30 30 30 90 90 30 30 30 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 operators 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 Xs 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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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 Ready Nov 10 1998 Operator ID Sequence # PUMPTUBING ASPR WOC
X X X X X X

12:31 sh 0630 EXT AUTO

Date Time Op ID OTHER 11/10/98 08:30 sh Comments: Weekly Maintenance 11/10/98 08:32 sh Comments: Weekly Maintenance 11/10/98 08:33 sh Comments: Weekly Maintenance 11/10/98 Comments: 10:30 sh

SHEAR VALVE
X X X

AIR FILTR

SYNG

APERTURES WIC RBC

SL
X X X

AUTO

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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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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NOTES

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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 Ready

Nov 11 1998 Operator ID Sequence #

12:10 CO3 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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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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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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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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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
Center Section Front Section Rear 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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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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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.

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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 Wheel


Figure 9.10:

Pump Shoe

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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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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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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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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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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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 Collar Figure 9.13:

Metal Brackets Pump Shoe

WOC Transfer Peristaltic Pump

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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 Ready

Nov 09 1998 Operator ID Sequence #

12:25 sh 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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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 AutoClean 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 2 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 2 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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As Required

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 laboratorys 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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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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As Required

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 Notch Figure 9.16:

Release Lever (Open Position)

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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Chapter 9

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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As Required

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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Chapter 9

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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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 valves 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.
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NOTES

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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.
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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

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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.

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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.

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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.

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NOTES

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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.

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Diagnostics Menu Flowchart


DIAGNOSTICS MENU Ready

FAULT REPORT

EXECUTION TIMES

CNT RATE SUMMARY

CLEAR FAULTS

RAW DATA SUMMARY

MORE

PRINT

MAIN

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

PRINT

RETURN

MOTOR SOLENOID OPERATION OPERATION

PUMP DRAIN OPERATION ACCUMULAT

INITIALIZATION

MORE

MAIN

CYCLE BANK

STEP SOLENOID

DIAGNOSTICS

DIGITAL READINGS

VOLTAGE READINGS

GAIN ADJUSTMNT

MORE

PRINT

MAIN

VACUUM PRESSURE INHIBIT ON ON PUMPS VACUUM PRESSURE ENABLE OFF OFF PUMPS

VACUUM TEST

PRESSURE TEST

DIAGNOSTICS

MOTOR PWR CHECKING

HOME MOTORS

EXERCISE MOTOR

SHEAR VAL SHEAR VAL PRINT TIME DISPENSE SHEAR VAL ASPIRATE

DIAGNOSTICS

FINISH SELECT

SELECT

DIGITAL READINGS

VOLTAGE READINGS

GAIN ADJUSTMNT

MORE

PRINT

MAIN

VERIFY GAINS

ENTER SETTINGS

AUTO GAIN ADJUSTMNT

CURRENT SETTINGS

SIGNAL GENERATOR

PRINT

DIAGNOSTICS

MAM TESTING

SPM TESTING

WIM TESTING

PRINT

RETURN

WOC DATA

RBC PLT WIC MORE DATA DATA DATA RBC PLT WIC HISTOGRAM HISTOGRAM HISTOGRAM

PRINT

MAIN

AUTO-SAMP BAR CODE BAR CODE VERSION ALIGNMENT VERIFY

SERIAL TEST

MORE

PRINT

MAIN

WOC 1 WOC 2 DATA DATA WOC 1 WOC 2 HISTOGRAM HISTOGRAM

CALC CV

SCATTER GRAPHS

SMOOTHING EXTENDED ON/OFF WOC COUNT

PRINT

DIAGNOSTICS

STOP TRANSMISS

TRANSMIT MESSAGE

DIAGNOSTICS

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DIAGNOSTICS MENU Ready

Dec 20 1998 Operator ID Sequence #

10:20 sh 0630

FAULT REPORT

EXECUTION TIMES

CNT RATE SUMMARY

CLEAR FAULTS

RAW DATA SUMMARY

MORE

PRINT

MAIN

Figure 10.1:
DIAGNOSTICS

First Diagnostics Menu Screen

The first DIAGNOSTICS MENU screen (see the preceding figure) and 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

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Chapter 10

FAULT REPORT

When the [FAULT REPORT] key is pressed, information regarding 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 Detergent empty

Dec 20 1998 Operator ID Sequence #

12:28 732 2715

Operator correctable fault report : Detergent empty

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

Figure 10.2:

Operator Correctable Fault Report Screen

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DIAGNOSTICS MENU Fault: See DIAG

Dec 20 1998 Operator ID Sequence #

12:20 732 2713

Fatal fault report : RBC diluent syringe overpressure

RBC diluent syringe overpressure FAULT REPORT EXECUTION TIMES CNT RATE SUMMARY CLEAR FAULTS RAW DATA SUMMARY MORE PRINT MAIN

Figure 10.3:

Fatal Fault Report Screen

DIAGNOSTICS MENU Ready

Dec 20 1998 Operator ID Sequence #

15:58 maa 1917

No fault pending

FAULT REPORT

EXECUTION TIMES

CNT RATE SUMMARY

CLEAR FAULTS

RAW DATA SUMMARY

MORE

PRINT

MAIN

Figure 10.4:

Fault Report No Fault Pending Screen

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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 TIMES

This key is for service use only.

DIAGNOSTICS MENU Ready

Dec 20 1998 Operator ID Sequence #

12:29 732 2715

WOC CNT RATE

RBC CNT RATE

PLT CNT RATE

WIC CNT RATE

PRINT

RETURN

Figure 10.5:
CNT RATE SUMMARY

Count Rate Summary Screen

When the [CNT RATE SUMMARY] key is pressed, the following soft 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.

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NOTE: The count rate and graphical data is available for

the previously run specimen only.

DIAGNOSTICS MENU Ready

Dec 20 1998 Operator ID Sequence #

12:30 732 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 CNT GRAPH

RBC CNT RATE

PLT CNT RATE

WIC CNT RATE

PRINT

RETURN

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.

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Chapter 10

DIAGNOSTICS MENU Ready

Dec 20 1998 Operator ID Sequence #

12:29 732 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 CNT RATE

RBC CNT RATE

PLT CNT RATE

WIC CNT RATE

PRINT

RETURN

Figure 10.7:
CLEAR FAULTS

WOC Count Rate Graph

When the [CLEAR FAULTS] key is pressed, the Analyzer returns to 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.

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DIAGNOSTICS MENU Ready

Dec 20 1998 Operator ID Sequence #

12:33 757 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 WIC Times Upper: 1.53 HGB Sample HGB Ref WOC Alg RBC Alg PLT Alg % Tot : 98.6% RER : 33.9% Adj cnt: 2728 1: 1218 2255

Count: 6.23 Count: 4.69 2: 1218 2254

Avg: 6.22 Avg: 4.69 3: 1219 2255

Timeout: 6.41 Timeout: 4.89 4: 1219 2255 5: 1219 2258

Lo thr: 40 Lo thr: 8

CTRUE : 342.4 Hi thr: 219

FAULT REPORT

EXECUTION TIMES

CNT RATE SUMMARY

CLEAR FAULTS

RAW DATA SUMMARY

MORE

PRINT

MAIN

Figure 10.8:
RAW DATA SUMMARY

Raw Data Summary Screen

When the [RAW DATA SUMMARY] key is pressed, detailed 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. 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.

PRINT

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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 Ready

Dec 20 1998 Operator ID Sequence #

10:20 sh 0630

MOTOR OPERATION

SOLENOID OPERATION

PUMP OPERATION

DRAIN ACCUMULAT

INITIALIZATION

MORE

MAIN

Figure 10.9:
MORE

Second Diagnostics Menu Screen

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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MOTOR OPERATION

This key is for service use only. The system must be initialized after this key is pressed. This key is for service use only. The system must be initialized after this key is pressed.

SOLENOID OPERATION

DIAGNOSTICS MENU Not Ready: See DIAG

Dec 20 1998 Operator ID Sequence #

12:34 757 3143

VACUUM ON

PRESSURE ON

VACUUM TEST

PRESSURE TEST

DIAGNOSTICS

Figure 10.10:
PUMP OPERATION

Pump Operation Screen

When the [PUMP OPERATION] key is pressed, the following soft key labels (see the preceding figure) are displayed: VACUUM ON or VACUUM OFF PRESSURE ON or PRESSURE OFF INHIBIT PUMPS* VACUUM TEST PRESSURE TEST DIAGNOSTICS * This key is displayed after either key listed above it is pressed. (The key label alternates between these two selections.) (The key label alternates between these two selections.)

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DIAGNOSTICS MENU Not Ready: See DIAG

Dec 20 1998 Operator ID Sequence #

12:36 732 2716

Vacuum is on

VACUUM OFF

PRESSURE ON

INHIBIT PUMPS

VACUUM TEST

PRESSURE TEST

DIAGNOSTICS

Figure 10.11:
VACUUM ON VACUUM OFF

Pump Operation Screen Vacuum ON

When the [VACUUM ON] key is pressed, the key label changes to [VACUUM OFF], the vacuum pump is turned ON, and the screen 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 ON PRESSURE OFF

When the [PRESSURE ON] key is pressed, the key label changes to [PRESSURE OFF], the pressure pump is turned ON, and the screen 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.

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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 Not Ready: See DIAG

Dec 20 1998 Operator ID Sequence #

12:36 757 3143

Pressure and vacuum are inhibited

VACUUM OFF

PRESSURE OFF

ENABLE PUMPS

VACUUM TEST

PRESSURE TEST

DIAGNOSTICS

Figure 10.12:
INHIBIT PUMPS ENABLE PUMPS

Inhibit Pumps Screen

When the [INHIBIT PUMPS] key is pressed, the key label changes to [ENABLE PUMPS], operation of the pumps is inhibited (no vacuum 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.

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DIAGNOSTICS MENU Vacuum Recovery Time Test

Dec 20 1998 Operator ID Sequence #

12:39 732 2716

Time elapsed : 3.3

Figure 10.13:
VACUUM TEST

Vacuum Test Screen

When the [VACUUM TEST] key is pressed, the system releases the 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 TEST

When the [PRESSURE TEST] key is pressed, the system releases the 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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DIAGNOSTICS MENU Draining accumulator

Dec 20 1998 Operator ID Sequence #

12:41 732 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 OPERATION

SOLENOID OPERATION

PUMP OPERATION

DRAIN ACCUMULAT

INITIALIZATION

MORE

MAIN

Figure 10.14:
DRAIN ACCUMULAT

Drain Accumulators Screen

When the [DRAIN ACCUMULAT] key is pressed, the internal vacuum 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.

INITIALIZATION

When the [INITIALIZATION] key is pressed, the Analyzer is 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.

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DIAGNOSTICS MENU Ready

Dec 20 1998 Operator ID Sequence #

10:21 sh 0630

DIGITAL READINGS

VOLTAGE READINGS

GAIN ADJUSTMNT

MORE

PRINT

MAIN

Figure 10.15:
MORE

Third Diagnostics Menu Screen

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 READINGS

This key is for service use only.

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Dec 20 1998 Operator ID Sequence #

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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

SELECT

DIGITAL READINGS

VOLTAGE READINGS

GAIN ADJUSTMNT

MORE

PRINT

MAIN

Figure 10.16:
VOLTAGE READINGS

Voltage Readings Screen

When the [VOLTAGE READINGS] key is pressed, the voltage and 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 ADJUSTMNT

This key is for service use only. The system may have to be initialized after this key is pressed.

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DIAGNOSTICS MENU Ready

Dec 20 1998 Operator ID Sequence #

10:21 sh 0630

WOC DATA

RBC DATA

PLT DATA

WIC DATA

MORE

PRINT

MAIN

Figure 10.17:
MORE

Fourth Diagnostics Menu Screen

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 Ready

Dec 20 1998 Operator ID Sequence #

12:49 C03 3122

AUTO-SAMP VERSION

BAR CODE ALIGNMENT

BAR CODE VERIFY

SERIAL TEST

MORE

PRINT

MAIN

Figure 10.18:
MORE

Fifth Diagnostics Menu Screen (CELL-DYN 3700SL System)

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 Ready

Dec 20 1998 Operator ID Sequence #

12:50 C03 3122

Auto-Sampler Software : X:VER X.XX XX-XX-XX

AUTO-SAMP VERSION

BAR CODE ALIGNMENT

BAR CODE VERIFY

SERIAL TEST

MORE

PRINT

MAIN

Figure 10.19:
AUTO-SAMP VERSION

Auto-Sampler Version Screen

This key is used to display the software version currently installed 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 ALIGNMENT

This key is for service use only and is displayed on the CELL-DYN 3700SL System only. This key is for service use only and is displayed on the CELL-DYN 3700SL System only.

BAR CODE VERIFY

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DIAGNOSTICS MENU Ready

Dec 20 1998 Operator ID Sequence #

12:51 C03 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 TRANSMISS

TRANSMIT MESSAGE

DIAGNOSTICS

Figure 10.20:
SERIAL TEST

Serial Test Screen

The [SERIAL TEST] key is used to test the functionality of the RS232 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 loopback 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 TRANSMISS

The [STOP TRANSMISS] key is used to abort any transmission that is in progress to an LIS.

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DIAGNOSTICS MENU Ready

Dec 20 1998 Operator ID Sequence #

12:52 C03 3122

Message sent : CELL-DYN serial interface test. Message received :

STOP TRANSMISS

TRANSMIT MESSAGE

DIAGNOSTICS

Figure 10.21:
TRANSMIT MESSAGE

Serial Test Transmit Message Screen Transmit Message

When the [TRANSMIT MESSAGE] key is pressed, the 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.

DIAGNOSTICS

The [DIAGNOSTICS] key is used to return to the previous DIAGNOSTICS MENU screen.

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NOTES

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Troubleshooting

Troubleshooting Guide
Overview
Good troubleshooting skills are learned by using a logical, stepby-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 systems 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

Blood Sensor Vent Tubing V Silicon Tubing Sleeve

Pulley Belt

A Sample Aspiration Tubing

Mounting Block

Locking Screw Vent/ Aspiration Needle Vent Reservoir Side Fitting

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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Vent Tubing V

A Sample Aspiration Tubing

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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Analyzer or Data Station will not power ON . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . No screen display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The MAIN MENU screen is not displayed after initialization . . . . . . . . . . . . . . . . . . . . . The word FAULT on the Analyzer Status Indicator Panel is illuminated in red . . . . . . . . Instrument will not stop cycling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Data Station keyboards, membrane (including soft keys) and external, are not operational . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Sample Loader does not power ON . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Sample Loader beeps and the Start key is not illuminated . . . . . . . . . . . . . . . . . . . . Shear Valve problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-62 10-62 10-62 10-63 10-63 10-64 10-64 10-65 10-65 10-65

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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 WIC WOC RBC PLT HGB Appropriate Graph WIC histogram Size/Complexity scatterplot and the NWBC-LYM-MONO histogram RBC and PLT histograms RBC and PLT histograms 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.


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Platelet background out of specification


Probable Cause(s) Electrical Interference Corrective Action 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 Contaminated/dirty RBC/PLT Diluent Syringe Salt buildup around RBC/PLT von Behrens Transducer Assembly Clean the RBC/PLT Aperture Plate (as directed in Chapter 9). Clean the RBC Diluent Syringe (as directed in Chapter 9). Perform Auto-Clean or Extended 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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WOC background out of specification


Probable Cause(s) Bubbles in WOC Flow Cell Bubbles in WOC Syringes Contaminated WOC Syringes Dirty WOC Flow Cell Contaminated Reagent Corrective Action Empty WOC Flow Cell. Clean the WOC Sheath Syringe and the WOC Metering Syringe (as directed in Chapter 9). Perform the Auto-Clean Procedure (as directed in Chapter 9). 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.

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WIC background out of specification


Probable Cause(s) Electrical Interference Corrective Action 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 Contaminated Reagent Clean the WIC Aperture Plate (as directed in Chapter 9). 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 Syringe Contaminated/dirty WIC/HGB Lyse Syringe Faulty Aperture Clean Circuit Clean the WIC/HGB Diluent Syringe (as directed in Chapter 9). Clean the WIC/HGB Lyse Syringe (as directed in Chapter 9). 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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RBC background out of specification


Probable Cause(s) Electrical Interference Corrective Action 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 Contaminated Reagent Clean the RBC/PLT Aperture Plate (as directed in Chapter 9). 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 Syringe Clean the RBC/PLT Diluent Syringe (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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Hemoglobin background out of specification


Probable Cause(s) Dirty HGB Flow Cell Corrective Action 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. 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 Syringe Clean the WIC/HGB Diluent Syringe.

Contaminated Reagent

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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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.) Corrective Action 1. Verify that the ground wires are securely connected and replace the front covers. Repeat the background count. 2. From the second SPECIAL PROTOCOLS 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. Allow the reagents to warm to room temperature and then repeat the background count. 4. From the second DIAGNOSTICS MENU 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. Clean the Diluent Syringe (as directed in Chapter 9). 6. Clean the Shear Valve (as directed in Chapter 9). Repeat the background count.

Probable Cause 1. The Analyzer front covers are removed.

2. Debris is present in the system or on the Aperture Plate.

3. The reagents are cold. NOTE: If reagents were frozen discard. 4. There is liquid in the Vacuum Accumulator.

5. There are bubbles in the Diluent Syringe. 6. The Shear Valve is dirty.

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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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Sampling Error Incomplete Aspiration: Open Mode


Probable Cause(s) Inadequate blood is aspirated. Corrective Action 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 completely through the Shear Valve before it rotates. Check that the Sample Aspiration Peristaltic Pump tubing is inserted 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.

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Sampling Error Incomplete Aspiration: Closed Mode (Cap Piercer System)


Probable Cause(s) Inadequate blood is aspirated. Corrective Action 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 Shear Valve before the sample cut is made. Check that the Sample Aspiration Peristaltic Pump tubing is inserted 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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Sampling Error Incomplete Aspiration: Closed Mode (Sample Loader System)


Probable Cause(s) Inadequate blood is aspirated. Corrective Action 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 Shear Valve before the sample cut is made. Check that the Sample Aspiration Peristaltic Pump tubing is inserted 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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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 1015 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.

Meniscus

Start Detector (Count 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) RBC/PLT Aperture Plate Corrective Action 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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WIC clog or flow errors


Probable Cause(s) WIC Aperture Plate Corrective Action 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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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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WOC flow errors


Probable Cause(s) Inappropriate kinetic rate of the WOC measurement Corrective Action Obtain kinetic rate information from 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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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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RBC/MCV/PLT data are imprecise or inaccurate


Cause of Inaccurate Result Worn Sample Aspiration Peristaltic Pump Tubing Shear Valve is not operating smoothly Bubbles or malfunction in RBC/PLT Diluent Syringe Corrective Action Replace the Sample Aspiration Peristaltic Pump Tubing (as directed in Chapter 9). Clean the Shear Valve (as directed in Chapter 9). Clean the RBC/PLT Diluent Syringe (as 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 RBC/PLT mixing chamber Trace air inlet lines for obstructions or crimps. Clean the RBC/PLT Aperture Plate (as directed in Chapter 9). Fragmented RBCs falsely elevate the platelet count Review a stained blood smear for the presence of fragmented RBCs. Perform the platelet count by an alternate method. Extremely microcytic RBCs may be counted as platelets Review a stained blood smear for the presence of extremely microcytic RBCs. Perform the platelet count by an alternate method. The RBCs are hyperosmolar in comparison to the diluent; therefore, water is drawn into the RBCs causing the RBCs to swell and falsely increase the MCV Red blood cell aggregates falsely decrease the RBC count NOTE: The MCV should be accurate because of Red Cell Editing Ratio (RER). Rerun the specimen. Use a microhematocrit procedure to determine the HCT value and calculate the MCV and MCHC. Warm the specimen and rerun. NOTE: The MCV should not change significantly after rerun.

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Platelet clumps falsely decrease the platelet count

Check the specimen for clots and/or the 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 The RBC/PLT Diluent Syringe contains salt crystals

Clean the RBC/PLT Aperture Plate (as directed in Chapter 9). Clean the RBC/PLT Diluent Syringe (as directed in Chapter 9).

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WOC data are imprecise or inaccurate


Cause of Inaccurate Result Worn Sample Aspiration Peristaltic Pump Tubing Worn WOC Transfer Peristaltic Pump Tubing Shear Valve is not operating smoothly Bubbles or malfunction in WOC Sheath Syringe or WOC Metering Syringe Corrective Action Replace the Sample Aspiration Peristaltic Pump Tubing (as directed in Chapter 9). Replace the WOC Transfer Peristaltic Pump Tubing (as directed in Chapter 9). Clean the Shear Valve (as directed in Chapter 9). Clean the appropriate WOC Syringe (as 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 Incorrect, contaminated, or expired reagents Empty and refill the WOC Flow Cell using SPECIAL PROTOCOLS menu features. Verify that the reagent lines are inserted into the correct reagent containers. Verify that the reagents have not expired. Replace Sheath Reagent if necessary. Inadequate mixing in the WOC Mixing Chamber Trace pressure and air inlet lines for 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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Certain red blood cells (for example, 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

Rerun specimen under [RESISTANT RBC].

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 Worn Sample Aspiration Peristaltic Pump Tubing Shear Valve is not operating smoothly Malfunction in WIC/HGB Diluent Syringe or WIC/HGB Lyse Syringe Corrective Action Replace the Sample Aspiration Peristaltic Pump Tubing (as directed in Chapter 9). Clean the Shear Valve (as directed in Chapter 9). Clean the appropriate Syringe (as directed in Chapter 9). Replace the appropriate Syringe (as directed in Troubleshooting Procedures within this chapter). Bubbles in WIC/HGB Diluent Syringe or WIC/HGB Lyse Syringe Dirty specimen path Clean the appropriate Syringe (as directed in Chapter 9). Perform the Auto-Clean Procedure (as directed in Chapter 9). Clean the Shear Valve (as directed in Chapter 9). Incorrect, contaminated, or expired reagents Verify that the reagent lines are inserted into the correct reagent containers. Verify that the reagents have not expired. Replace reagent as required. Inadequate mixing in the von Behrens WIC/HGB Transducer Trace air inlet lines for obstructions or crimps.

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Troubleshooting Chapter 10 Hemoglobin data are imprecise or inaccurate


Cause of Inaccurate Result Worn Sample Aspiration Peristaltic Pump Tubing Malfunctioning WIC/HGB Diluent Syringe or WIC/HGB Lyse Syringe Corrective Action Replace the Sample Aspiration Peristaltic Pump Tubing (as directed in Chapter 9). Clean the appropriate Syringe (as directed in Chapter 9). Replace the appropriate Syringe (as directed in Chapter 9). Bubbles in WIC/HGB Diluent Syringe or WIC/HGB Lyse Syringe Dirty specimen path Clean the appropriate Syringe (as directed in Chapter 9). Perform the Auto-Clean Procedure (as directed in Chapter 9). Clean the Shear Valve (as directed in Chapter 9). Incorrect, contaminated, or expired reagents Verify that the reagent lines are inserted into the correct reagent containers. Verify that the reagents have not expired. Replace reagent as required. Inadequate mixing in the von Behrens WIC/HGB Transducer A dirty Hemoglobin Flow Cell Trace air inlet lines for obstructions or crimps. 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 in the HGB dilution A high bilirubin absorbs enough light at 540 nm to increase the HGB OR Free plasma HGB from in vivo hemolysis Centrifuge the specimen. Remove a specific volume of plasma and replace with an equal volume of diluent. Resuspend the red blood cells. Rerun. OR 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.
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>>>> 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 Data exceed linear range for that parameter Corrective Action For RBC or HGB: Dilute a 0.5-mL aliquot 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.

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Observable Fault Conditions Analyzer or Data Station will not power ON.
Probable Cause 1. Power source is defective. Corrective Action 1. Verify that the power switch is turned OFF and connect the system to a different power source. 2. Ensure that the power cord is securely connected to the Analyzer or Data Station and verify that it is connected to the power outlet. 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 malfunction. 4. Call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).

2. Power cord is not securely connected to the Analyzer or is not connected to the power outlet. 3. Analyzer fuse is blown or incorrect.

No screen display.
Probable Cause 1. Monitor power switch is turned OFF. 2. Data Station power switch is turned OFF. 3. Brightness control is turned down. 4. Defective Data Station or other component. Corrective Action 1. Turn the monitor power switch ON. 2. Turn the power switch ON. 3. Adjust the brightness control on the Data Station until the image is visible. 4. Call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).

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The MAIN MENU screen is not displayed after initialization.


Probable Cause 1. There is a floppy disk in the Data Station disk drive. 2. A file is missing or is incorrect on the Data Stations hard drive. 3. There is a hardware or software malfunction. Corrective Action 1. If a disk is present, remove it and initialize the Data Station by turning the power switch OFF and ON. 2. Call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US). 3. Call Abbott Diagnostics Customer 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 1. The Analyzer has detected a fault situation and has inhibited operation. Corrective Action 1. From the first DIAGNOSTICS MENU 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.

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Instrument will not stop cycling.


Probable Cause 1. The touch plate is stuck or being held down in some way. 2. Circuitry malfunction. Corrective Action 1. Check the touch plate and remove any obstructions. Verify that it is not sticking by pressing it several times. 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 1. The computer is performing a function that inhibits the keys. 2. There is an incomplete operator entry. 3. A data transmission to the printer or laboratory computer is in progress. 4. Keyboard entry is not possible on the displayed screen. 5. Data Station computer, keyboard and/ or circuitry malfunction. Corrective Action 1. No action required. Refer to the screen for the current Status Box message. 2. Complete the operator entry or press the Esc key on the keyboard. 3. No action required. Refer to the screen for the current Status Box message. 4. No action required. Refer to the screen for the current Status Box message. 5. Initialize the Analyzer by pressing the [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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The Sample Loader does not power ON.


Probable Cause 1. Circuitry malfunction. Corrective Action 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 1. The cable that connects the Sample Loader to the Analyzer is loose or disconnected. Corrective Action 1. Check that each end of the cable is securely connected. If necessary, remove the cable and reconnect it. Press the INT key on the Sample Loader operation keyboard to initialize the Sample Loader. 2. Call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).

2. Circuitry malfunction.

Shear Valve problems.


Observable Condition: The Shear Valve is leaking. Corrective Action 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.

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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

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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

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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 instruments status or prompt the operator to take action relative to the last operator entry. 2. General Fault Conditions indicate fault or error detection.

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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 ESTOP 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.
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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].

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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.

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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.

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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.

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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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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.

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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 1. The Sample Loader detected a hardware fault and ceased operation. Corrective Action 1. From the first DIAGNOSTICS MENU screen, 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 1. The Sample Loader did not respond to an Analyzer command. Corrective Action 1. Ensure that the Sample Loader power 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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Auto-Sampler consecutive data faults


This message is displayed in the Bulletin Line. Probable Cause 1. During sample processing, four consecutive incomplete aspiration or metering faults were detected and the Sample Loader halted. Corrective Action 1. Correct the situation on the Analyzer as follows: Check the appropriate tubing for a 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 1. Four sequential clog or flow messages occurred during Sample Loader operation. Corrective Action 1. Follow the instructions given in Symptom Identification and Resolution within this chapter for troubleshooting clog, flow, or incomplete aspiration messages.

2. Four sequential incomplete aspiration messages occurred during Sample Loader operation.

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Bad checksum in nonvolatile RAM


This message is displayed in the Bulletin Line. Probable Cause 1. When the system was powered ON, the Analyzer did not transmit the correct message to the Data Station. Corrective Action 1. 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).

Bad monitor command


This message is displayed in the Bulletin Line. Probable Cause 1. The Analyzer did not initialize properly when the system was turned ON. Corrective Action 1. 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).

Blood in Auto-Sampler Line


This message is displayed in the Bulletin Line. Probable Cause 1. At the end of the count cycle, the instrument detects blood in the sample line that runs from the top of the Sample Loader tower to the Shear Valve. When this occurs, the system automatically cleans the needle and the sample line. If blood is still present in the line, the Analyzer halts. Corrective Action 1. Check the sample line to see if it contains blood. If it does, clean or replace the Sample Loader needle or sample line. 2. Check for a crimp in the sample aspiration tubing between the Sample Loader and the Analyzer.

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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Blood in Shear Valve Line


This message is displayed in the Bulletin Line. Probable Cause 1. At the end of the count cycle, the instrument detects blood at one of the 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. Corrective Action 1. Clean the Shear Valve (as directed in Chapter 9).

Data acquisition overlap


This message is displayed in the Bulletin Line. Probable Cause 1. The timing of communication between the Analyzer and the Data Station is incorrect. Current specimen data is received while previous specimen data is being processed. Corrective Action 1. Document what was happening when the message was displayed and report the problem to Abbott Diagnostics Customer Service. Initialize the 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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Diluent, Lyse, Sheath, or Detergent empty


This message is displayed in the Status Box and Bulletin Line. Probable Cause 1. Container is empty. Corrective Action 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. Inspect the inlet tubing to ensure it is not crimped and/or remove any obstruction. Run 5 or more background counts and review results. 3. Ensure that the line is properly inserted in the container and the sinker is on the bottom of the container. Run 5 or more background counts and review results. 4. Check the label on the reagent container to be sure the correct reagent is installed. 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. Call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).

2. Reagent inlet tubing is crimped or obstructed.

3. Reagent line is not on the bottom of the container.

4. An incorrect reagent or a nonconductive liquid is connected to the inlet tube.

5. Circuitry malfunction.

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External waste full


This message is displayed in the Status Box. Probable Cause 1. Waste container full. Corrective Action 1. Empty the waste container and/or replace it. Press [CLEAR FAULTS] to resume operation. 2. Reconnect the waste sensor connector and then press [CLEAR FAULTS]. 3. Inspect wires and electrodes and call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US). 4. Call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).

2. Waste sensor connector is loose or disconnected. 3. Shorted wire(s) or electrode(s) on the waste cap.

4. Circuitry malfunction.

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 1. An internal Analyzer flow sequence was not completed in the allotted time. Corrective Action 1. Record the characters in the brackets. 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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Initialization Failed
This message is displayed at the bottom of the screen. (MAIN MENU is not displayed.) Probable Cause 1. The Data Station was unable to initialize. The CELL-DYN software does not display the MAIN MENU screen. Corrective Action 1. Initialize the Analyzer by following the instructions in Power OFF Procedure 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 1. The order of the data received by the Data Station during a measurement was incorrect. Corrective Action 1. Call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).

Message acknowledgment time out


This message is displayed in the Bulletin Line. Probable Cause 1. Communication between the Analyzer and the Data Station did not occur when expected. Corrective Action 1. 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).

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Message reception time out


This message is displayed in the Bulletin Line. Probable Cause 1. Communication between the Analyzer and the Data Station did not occur when expected. Corrective Action 1. Make sure the cable between the analyzer and Data Station is securely 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 accompanied by a sampling error; therefore, SAMPLING ERR is printed on all reports. Probable Cause 1. The Sample Loader mixing head(s) detected resistance when attempting to mix a sample. Therefore, no sample was aspirated and results appear to be a background count. 2. One or both mixer motors is binding and generating resistance. Corrective Action 1. Check to be sure that the sample tube can spin freely in the Sample Loader rack. If necessary, remove excess labels or obstructions. Repeat the sample. 2. Call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).

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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 1. A situation that prevents the Ready state has been detected. See the DIAGNOSTICS MENU screen or the SPECIAL PROTOCOLS MENU screen, whichever is indicated, for more information. 2. A diagnostic test was run using one of the DIAGNOSTICS MENU screen keys. Corrective Action 1. From the first DIAGNOSTICS MENU screen, press [FAULT REPORT] followed by [PRINT] to obtain a printout describing the problem. Refer to the appropriate table for corrective action. 2. The instrument must be initialized when the diagnostic test in progress is complete. Initialize the Analyzer by pressing the [INITIALIZATION] key on the second DIAGNOSTICS MENU screen. 3. Check the SPECIAL PROTOCOLS MENU screen and perform the action necessary to complete the procedure. 4. Call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).

3. A Special Protocols procedure is in progress. 4. System malfunction.

Printer (Graphics or Ticket) unavailable


This message is displayed in the Bulletin Line. Probable Cause 1. The print buffer (the memory area where the material is stored while awaiting printing) is full. 2. The printer is turned OFF. 3. The printer is not on-line. Corrective Action 1. Press the [STOP PRINTING] key on the CUSTOMIZE PRINTED REPORT screen for the appropriate printer. 2. Turn the printer power switch ON. 3. Check that the printer on-line indicator is illuminated. If necessary, refer to the printer manual for assistance. 4. Check the printer cable connection on 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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4. The printer is disconnected or the connection is loose.

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RBC diluent syringe overpressure


This message is displayed in the Status Box. Probable Cause 1. The Shear Valve did not rotate completely or in the time allotted. 2. The center section of the Shear Valve is installed backwards. 3. Tubing connected to RBC/PLT Diluent Syringe is twisted or crimped. 4. Excessive pressure was detected during the up-stroke of the RBC Diluent Syringe. Corrective Action 1. Clean the Shear Valve (as directed in Chapter 9). 2. Verify that the center section of the Shear Valve is installed correctly. 3. Check tubing connected to the RBC/ PLT Diluent syringe. 4. a. Remove the RBC diluent syringe from its bracket (make sure 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 1. The timing for the RBC/PLT Metering was outside acceptable limits. Corrective Action 1. Repeat the sample. If the problem was 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.
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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 1. The blood sensors did not detect a sufficient amount of sample on either side of the Shear Valve after aspiration. Corrective Action 1. Check the sample tube to be sure it contains a sufficient quantity of blood. 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/L 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 1. The Shear Valve did not rotate properly or in the allotted time. Corrective Action 1. Clean the Shear Valve (as directed in Chapter 9).

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Uninitialized
This message is displayed in the Status Box. Probable Cause 1. Data Station has power but the Analyzer is not responding. Corrective Action 1. Ensure that the Analyzer power cord is 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. Check the cable that connects the Analyzer to the Data Station. If necessary, secure the connections. Initialize the Analyzer by pressing the [INITIALIZATION] key on the second DIAGNOSTICS MENU screen.

2. Communication malfunction between the Analyzer and Data Station.

Vacuum accumulator wet (1 or 2)


This message is displayed in the Bulletin Line. Probable Cause 1. The internal vacuum accumulator has filled with liquid beyond allowable limits. Corrective Action 1. From the second DIAGNOSTICS MENU 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. 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).

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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 1. The timing for the WIC metering was outside acceptable limits. Corrective Action 1. Repeat the sample. If the problem was 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 1. An increasing WOC count rate was detected in the WOC flow cell during the WOC measurement. Corrective Action 1. Repeat the sample.

2. Replace the WOC Transfer Peristaltic Pump Tubing as directed in Chapter 9. 3. Clean the WOC Metering Syringe as directed in Chapter 9.

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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.

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Overview

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NOTES

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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 preprinted 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.

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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.

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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 tha