Cell Dyn 1600 Operator Manual PDF

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CELL-DYN® 1600 System

OPERATOR’S MANUAL
CD-TOC LIST NO: 92352-01 EXIT
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• Table of Contents
• Introduction
• System Description
• Installation
• Principles of Operation
• System Specifications
• Operating Instructions
• Calibration
• Quality Control
• Precautions, Limitations, Hazards
• Maintenance
• Troubleshooting
• Printer
• Closed Sampler Module
• Appendices
ABBOTT LABORATORIES ENTIRE CONTENTS COPYRIGHT

ABBOTT PARK, IL 60064 U.S.A. ABBOTT LABORATORIES 1993
PRINTED IN U.S.A.
SEARCH BOOK TOC GO BACK
Table of Contents
Introduction Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
Proprietary Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
Abbott Instrument Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Abbott Customer Support Center . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv
Conventions Used in This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v
Revision Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii
Signature Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii
Reference List of Trademarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix
Part Number List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x
1. System Description
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Specimen Analyzer Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Data Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Flow Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Lower Left Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Upper Right Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Reagent System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
2. Installation Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

Initial Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Printer Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Tube and Diluent Syringe Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Flow Panel Inspection and Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Data Diskette Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
Power On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
Setup System Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Keypad Setups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
Auto-Startup Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21
3. Principles of Operation
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Sample Analysis Cycle Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
WBC Measurement Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
WBC Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
RBC/PLT Measurement Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
RBC Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
CELL-DYN® 1600 Operator's Manual Table of ContentsC1

9140214 Rev ECFebruary 1994
PLT Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

PLT Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
Hemoglobin Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
Operational Messages and Data Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
Parameter Flagging Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
4. System Specifications
Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Data Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Power Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Operational Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Measurement Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Performance Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
5. Operating Instructions
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Routine Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Setup System Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Specimen Collection and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
Sample Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
Daily Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
Power Off Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
Using the Data Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13
6. Calibration Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

Calibration Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Whole Blood Calibration Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Pre-Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Calibration Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
Auto-Cal Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9
Factor Entry Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Pre-Dilute Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13
Latex Particles Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16
Lyse Volume Dispense Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-18
7. Quality Control
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Quality Control Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
X-B File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Table of ContentsC2 CELL-DYN® 1600 Operator's Manual

Quality Control Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4

Running Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
Westgard Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
Commercial Controls QC Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8
Replicate Specimen QC Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9
X-B Analysis QC Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9
Establishing the Target Value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10
Interpreting X-B Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11
CELL-DYN Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11
8. Precautions, Limitations and Hazards

Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Location Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Electrical Safety Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Mechanical Safety Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Infection Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Decontamination Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Blood Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Spills . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Reagent Storage and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Printer Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
9. Maintenance Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1

Special Protocols Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Preventive Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Daily Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Daily Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Weekly Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
Open Sampler Auto Clean . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
Aspiration Probe Exterior Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
Closed Sampler Auto Clean . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
Closed Sampler Holder Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
Monthly Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8
Lyse Inlet Tubing Rinsing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8
Rear Fan Filters Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9
Nonscheduled Maintenance Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-10
Nonscheduled Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-11
Supplemental Aperture Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-11
Aperture Plates Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13
Diluent Syringe Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-16
Sample Syringe Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-19
Sample Aspiration Probe Interior Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . 9-22
HGB Flow Cell Manual Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-24
Vent Line Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-26

Accumulator Draining and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-27

Preparing the Analyzer for a Prolonged Period of Non-Use
or for Shipping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-28
Aspiration Probe Removal and Replacement . . . . . . . . . . . . . . . . . . . . . . . . 9-29
Preventive Maintenance Log for CELL-DYN 1600 . . . . . . . . . . . . . . . . . . . . . . 9-31
10. Troubleshooting
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5
11. Printers Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
12. CELL-DYN 1600CS Closed Sample Aspiration Module Addendum

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
Flow Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2
Closed Sample Aspiration Module Installation . . . . . . . . . . . . . . . . . . . . . . . . . 12-3
Tube Guide Adjustment Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-4
Overview of the Run Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5
Verification and Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5
Closed Mode Calibration Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-6
Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-6
Closed Mode Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-7
Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-8
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-10
Mode to Mode Verification & Calibration Worksheet . . . . . . . . . . . . . . . . . . . 12-11
Mode to Mode QC Verification Logsheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-13
Appendices
Tables Table T-1: Potential Causes of Erroneous Results with
Automated Cell Counters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . T-1
Table T-2: Normal Values for Automated Blood Counters . . . . . . . . . . . . . . . . T-2
Table T-3: Anemia Classification Based on MCV and RDW . . . . . . . . . . . . . . . T-3
Table T-4: Progressive Stages of Iron Deficiency . . . . . . . . . . . . . . . . . . . . . . . T-3
Table T-5: Morphophysiological Classification of Red Cell
Disorders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . T-4
Table T-6: Result Abnormalities Caused by Artifacts . . . . . . . . . . . . . . . . . . . . T-4

Figures Figure 1-1 Front Panel View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

Figure 1-2 Flow Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Figure 1-3 Lower Left Side Panel Components . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Figure 1-4 Rear Panel Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Figure 1-5 Upper Right Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Figure 2-1 CELL-DYN 1600 Interface Panel (Right Side) . . . . . . . . . . . . . . . . . . 2-3
Figure 2-2 Lower Left Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Figure 2-3 Diluent Syringe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Figure 2-4 Upper and Lower Front Cover Removal . . . . . . . . . . . . . . . . . . . . . . . 2-8
Figure 2-5 Flow Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Figure 6-1 Removing the Front Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-14
Figure 6-2 Vial Closure for Mixing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15
Figure 9-1 Location of Dilution Baths . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13
Figure 9-2 Aperture Plate Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-14
Figure 9-3 Diluent Syringe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-17
Figure 9-4 Sample Syringe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-20
Figure 9-5 Sample Aspiration Probe Assembly . . . . . . . . . . . . . . . . . . . . . . . . . 9-22
Figure 9-6 HGB Flow Cell Manual Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-25
Figure 12-1 Closed Sampler . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2
Figure 12-2 Internal Flow Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2
Figure 12-3 Tube Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-4
Tables Table 2-1 Power Source Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

Table 2-2 Main Setup Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
Table 2-3 Acceptable Background and Count Time Data . . . . . . . . . . . . . . . . . . 2-22
Table 4-1 Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Table 4-2 Dimensions After Packaging for Shipment . . . . . . . . . . . . . . . . . . . . . 4-1
Table 4-3 Power Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Table 4-4 Linearity Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Table 4-5 Precision at 25EC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Table 10-1 Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-7


Foreword Congratulations on becoming a proud operator of the CELL-DYN® System. Using

state-of-the-art technology, we have designed your instrument to function
consistently and dependably on a day-to-day basis.
The CELL-DYN System is backed by dedicated professionals who excel in

engineering, training and technical expertise. As a valued customer, we will teach
you how to operate, maintain and troubleshoot your system.
For continuing service, we also provide telephone technical assistance should you
need additional information or assistance in diagnosing a problem. This service is
available 7 days a week, 24 hours a day.
If a problem should arise that cannot be resolved by telephone, on-site support is

offered by Abbott's Field Engineers. Our Field Engineers are extensively trained in
all aspects of Abbott instrumentation, which assures proficiency in diagnosing,
isolating and correcting problems.
Abbott Laboratories is dedicated to manufacturing the highest quality, most reliable

instrumentation available. We look forward to serving your needs in any way
possible.
Proprietary Information
Entire contents copyright 1994 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.
The CELL-DYN instrument system is covered by the following U.S. patent:

4,710,021.
All operating instructions must be followed. In no event shall Abbott be responsible

for failures, errors or other liabilities resulting from customer's noncompliance with
the procedures and precautions outlined herein.
CELL-DYN® 1600 Operator's Manual i

Abbott Instrument Warranty

For U.S. Customers Only
Abbott Laboratories warrants CELL-DYN® Instruments sold by Abbott Sales
Representatives (the "Instrument") to be free from defects in workmanship and
materials during normal use by the original purchaser. This warranty shall continue
for a period of one (1) year, commencing twenty-one (21) days from 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 your Abbott Customer
Support Center immediately and be prepared to furnish pertinent details concerning
the defect, the Instrument model number and the serial number.
Abbott's Warranty coverage limits are as follows:
1. 24 hour-7 day/week phone support from our Customer Support Center.
2. 8:30 a.m.-5:00 p.m. (Monday-Friday, excluding all Abbott-observed

holidays) Field Service Engineer support.
3. Any on-site service performed at other times, and all service required to
correct defects or malfunctions not covered by this Warranty (as noted in the
paragraph below) will be billed at Abbott's labor rates then in effect.
This warranty does not cover defects or malfunctions which:
1. Are not reported to Abbott during the Warranty Period and within one week
of occurrence.
2. Result from chemical decomposition or corrosion.
3. Are caused by customer or third party abuse, misuse or negligence, or by

failure to comply with any requirement or instruction contained in the
applicable Abbott Operator's Manual.
4. Result from maintenance, repair or modification performed without Abbott's

authorization.
ii CELL-DYN® 1600 Operator's Manual

Abbott's liability for all matters arising from the supply, installation, use, repair and
maintenance of the Instrument, whether arising under this Warranty or otherwise,
shall be limited solely to the repair or (at Abbott's sole discretion) replacement of the
Instrument or of components thereof. In no event shall Abbott be liable for injuries
sustained by third parties, incidental or consequential damages or lost profits.
Replaced parts shall become the property of Abbott Laboratories.
The foregoing is the sole warranty made by Abbott Laboratories 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.
The CELL-DYN® 1600 Series Hematology Systems are manufactured by Abbott

Diagnostics, a wholly owned subsidiary of Abbott Laboratories, Abbott Park, IL
60064, U.S.A. Please direct all inquiries concerning information in this manual to
the foregoing address.
NOTE Direct all inquiries regarding equipment problems to the Abbott Customer Support
Center. (U.S. customers only.)
CELL-DYN® 1600 Operator's Manual iii

Abbott Customer Support Center

5440 Patrick Henry Drive
Santa Clara, CA 95054
1-800 CELLDYN (235-5396)
iv CELL-DYN® 1600 Operator's Manual

Conventions Used in This Manual

The following conventions are used in this manual:
INFORMATION HOW PRESENTED
Menu name Helvetica equivalent, CAPITAL letters
Key names below screen Helvetica bold equivalent, enclosed in []
Numeric and special Times Roman equivalent, Initial

function keypad Capital letters
Status Helvetica equivalent, CAPITAL letters
Message Helvetica bold equivalent,

CAPITAL letters, enclosed in <>
CELL-DYN® 1600 Operator's Manual v

vi CELL-DYN® 1600 Operator's Manual

The Revision status of the manual is indicated below. Be sure that the manual contains the latest revision number
of all pages.
REVISION STATUS
Revision Number Pages Revised and Added
Originally Issued B 9211352A B 12/88 Not applicable.
9211352B B 4/89 Added Addendum for CELL-DYN 1600CS.
9211352C B 12/92 Added cross-reference Part Number list and name

change from Unipath to Abbott Laboratories.
92352-01C B 2/93 Changed Part Number 9211352 to Abbott List

Number 92352-01.
92352-01D B 6/93 All pages (Part No. 9140214 Rev D B June 1993).
92352-01E - 12/94 Introduction: updated telephone numbers, patents,

trademarks, and parts lists (pp. i, iv, ix, x, xii);
Chapter 1: deleted reference to DYN-A-PAK (p. 1-
10); Chapter 3: added description of WBC R4 flag
(p. 3-15); Chapter 4: added information regarding
material used to verify linearity specifications (p. 4-
3); Chapter 7: modified assay and differential
percent verification guidelines (pp. 7-5 and 7-6);
Chapter 12 (Closed Sampler Aspiration Module):
added instructions for closed mode performance
verification with patient samples (p. 12-8).
92352-01F - 4/96 The following pages have changed (Part No.

9140214 Rev F B April 1996): Introduction (p. vii
and viii); Chapter 1 (p. 1-9 and 1-10); Chapter 5
(p. 5-7, 5-8, 5-9, and 5-10); Chapter 6 (p. 6-7 and
6-8); Chapter 7 (p. 7-5, 7-6, 7-9, and 7-10);
Chapter 8 (p. 8-1 and 8-2); Chapter 9 (p. 9-7, 9-8,
9-9, 9-10, 9-31, and 9-32); Chapter 10 (p. 10-7,
10-8, 10-9, and 10-10); Chapter 12 (p. 12-5, 12-6,
12-9, 12-10, 12-11, and 12-12).
©1993, 1994, and 1996 Abbott Laboratories, Abbott Park, IL 60064.
CELL-DYN® 1600 Operator's Manual vii

9140214 Rev FCApril 1996
This page has been added in order to maintain a record of persons who review this manual on a periodic basis.
Signature Date
viii CELL-DYN® 1600 Operator's Manual

Reference List of Trademarks

The following trademarks are referred to throughout this manual:
Teflon is a registered trademark of E. I. duPont de Nemours.
Vacutainer is a registered trademark of Becton Dickinson and Company.
CELL-DYN® 1600 Operator's Manual ix

Part Number List

CELL-DYN 1600/1600CS
CELL-DYN Reagents
Abbott List No. Description Configuration
99226-01 Diluent, Diff-Screen 4 x 3.8 Liters
99220-01 Diluent, Diff-Screen 1 x 20 Liters
99229-01 Diluent, Diff-Screen 1 x 3.8 Liters
98329-01 Detergent, Diff-Screen 1 x 3.8 Liters
99326-01 Detergent, Diff-Screen 4 x 3.8 Liters
99320-01 Detergent, Diff-Screen 1 x 20 Liters
99435-01 Lytic Agent, Diff-Screen 1 x 960 mL
99420-01 Lytic Agent, Diff-Screen 1 x 3.8 Liters
CELL-DYN Controls & Calibrators
99109-01 CELL-DYN®16 Tri-Level Control 12 x 2.5 mL
99131-01 CELL-DYN®16 Tri-Level Control (Vac Tube) 12 X 3.0 mL
99110-01 CELL-DYN®16 Calibrator 2 X 2.5 mL
x CELL-DYN® 1600 Operator's Manual

CELL-DYN Consumables
99644-01 CELL-DYN® Enzymatic Cleaner 2 X 50 mL
93641-01 CELL-DYN® Enzymatic Cleaner 1 x 50 mL
99610-01 CELL-DYN® Micro-Pipettes, 40 FL 100/pkg.
99620-01 CELL-DYN® Printout Tickets - TP250 1000/pkg.
30005-01 Graphic Printer Paper, (8-1/2 x 11) 2600/pkg.
91282-01 Eaton TP250 Ticket Printer Ribbon 1
93400-01 Epson FX85 Graphic Printer Ribbon 1
13401-01 Okidata 320 Graphics Ribbon 1
93410-01 Fujitsu DX2100 Graphics Ribbon 1
13411-01 Citizen MSP-40 Graphics Ribbon 1
13412-01 Citizen 120-D Graphics Ribbon 1
99660-01 DYN-A-WIPES Lint-Free Wipes 125/pkg.
98661-01 DYN-A-WIPES Lint-Free Wipes 40 boxes/case
99605-01 CELL-DYN® Sample Vials 500/pkg.
99606-01 CELL-DYN® Sample Vials 3000/pkg.
CELL-DYN® 1600 Operator's Manual xi

CELL-DYN Parts & Accessories
54305-01 Aperture Brush 1
91125-01 Dura Clamps 2
93040-01 Fan Filter (Large) 2
14850-01 Graduated Cylinder 2
91485-01 Peristaltic Pump Tubing (Medium) 4/pkg.
93009-01 Peristaltic Pump Tubing/CS Cap Piercer 1
93501-01 Power Cord 1
93164-01 Sample Probe - 1600 1
28541-01 Syringe, 10 mL, Diluent 1
91012-01 Teal Line Filter 1
* Assy, detergent, cap 1
* Assy, diluent, cap 1
* Assy, Lyse Cap (1 Liter) 1
* Assy, Lyse Cap (4 liter) 1
91072-01 Reagent Line Kit, dil, det, lyse 1
* Waste Cap Assy 1
92352-01 Operator's Manual 1
93140-01 System Disk, CELL-DYN 1600 1
92274-01 WBC Transducer 1
92264-01 RBC Transducer 1
* Interface Cable 1
* Fuse SB 5.0 amps 1
* Fuse SB 2.5 amps 1
25903-01 O-Ring/Probe Wash 2
* Latex Particles 3.31 DIA 1
* Latex Particles 5.0 DIA 1
*To place an order for products that do not have a List Number, contact the Customer Service Center in Santa Clara at 1-
800-933-5535.
To place an order for products that have a List Number, contact the Customer Service Center in Chicago at
1-800-323-9100.
If you require technical assistance on your CELL-DYN instrument, contact the Customer Support Center at
1-800-CELLDYN.
xii CELL-DYN® 1600 Operator's Manual

Chapter 1 System Description
System Description
Introduction The CELL-DYN® 1600 is a multi-parameter hematology analyzer designed for in

vitro diagnostic use in clinical laboratories. The instrument has two versions, the
CELL-DYN 1600, which accepts specimens from open collection tubes only, and
the CELL-DYN 1600CS, which accepts specimens in either open or closed
collection tubes.
The CELL-DYN 1600CS is equipped with an attached 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 sampler module. Operating and
maintenance instructions for the CELL-DYN 1600CS are described in the
Addendum for the CELL-DYN 1600CS operation.
Intended Use The CELL-DYN 1600 generates the following measurements on EDTA
anticoagulated whole blood:
WBC — White Blood Cell or leukocyte count

RBC — Red Blood Cell or erythrocyte count
HGB — Hemoglobin concentration
PLT — Platelet or thrombocyte count
LYM — Lymphocyte absolute count
%LYM — Lymphocyte percent
GRAN — Granulocyte abslolute count
%GRAN — Granulocyte percent
MID — Mid-range absolute count
%MID — Mid-range percent
MCV — Mean Cell Volume
HCT — Hematocrit
MCH — Mean Cell Hemoglobin
MCHC — Mean Cell Hemoglobin Concentration
RDW — Red Cell Distribution Width
MPV — Mean Platelet Volume
PCT* — Plateletcrit
PDW* — Platelet Distribution Width
* Clinical significance has not been established for these parameters. Therefore,
they are not reportable.
System Components
The CELL-DYN 1600 is a single unit that includes a specimen analyzer and a data
module.
CELL-DYN® 1600 Operator's Manual 1-1

9140214 Rev E — February 1994
System Description Chapter 1
Specimen Analyzer
The Specimen Analyzer section contains the hardware to aspirate, dilute, and
analyze each whole blood specimen.
Data Module The Data Module section includes the computer, video display monitor, membrane
keypad, disk drive, and printer. The disk drive is described in the Right Panel section
of this chapter. The printers are described in Chapter 11, Printers.
Specimen Analyzer Components

Front Panel The components visible on the front of the analyzer are identified in Figure
1-1. The functional description of each component follows.
Figure 1-1 Front Panel View
Upper Front Cover
The Upper Front Cover protects the upper flow panel. A green grounding wire
provides electrical continuity for shielding purposes. Access to the upper flow panel
is necessary to completely view the operation of the upper flow panel components
and to perform certain maintenance operations.
Lower Front Cover
The Lower Front Cover protects the lower section of the flow panel. Access to the
lower flow panel is necessary to view the action of the lower flow panel components
and to perform certain maintenance procedures.
1-2 CELL-DYN® 1600 Operator's Manual

Sample Aspiration Probe
The Sample Aspiration Probe is used to aspirate whole blood from an opened
collection tube or from a sampling cup in the CELL-DYN 1600CS. After each
aspiration, waste liquid on the outside of the probe is removed as the probe is drawn
through the wash block.
Touch Plate The Touch Plate is a spring plate located directly behind the sample aspiration probe.
Pressing the touch plate starts the selected run cycle.
Data Module The Data Module contains the video display monitor, central processing unit, and
membrane keypad. CELL-DYN 1600 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 transferred to an external computer through an

RS232 connector on the back panel. Data transmission may be done either
automatically as samples are processed or by command of the operator. Parallel data
may be output to an on-line printer.
Data Storage Results are stored on the disk drive for the most recent 320 cycles. No graphic data
are stored. The 3.5" disk drive is located below the membrane keypad of the CELL-
DYN 1600.
Video Display Screen
A 14-inch diagonal monochrome Video Display Screen displays all alphanumeric

and graphic data.
Membrane Keypads
A row of eight unlabeled pressure-sensitive 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.
A numeric and special function keypad is located directly below the row of eight
unlabeled keys. Each key generates an audible tone when pressed. This membrane
keypad contains the following numeric and special function keys:
Numeric Keys — a block of ten numeric keys, labeled from 0 to 9, and a

decimal key which are used to enter numeric data

ENTER Key — stores entered numeric data and advances the cursor to the
next entry location
Asterisk (*) Key — allows the operator to escape (abort) data entry before it
is completed
Arrow Keys — a set of four keys used to move the cursor in the direction
depicted by each arrow
Pound (#) Key — used for service functions only
Flow Panel The major components of the Flow Panel are depicted in Figure 1-2. The functional
description of each component follows.
Figure 1-2 Flow Panel
Wash Block The Wash Block rinses the outside of the sample aspiration probe with Diluent.
Excess Diluent is routed to the waste container.
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 is used to meter a fixed
volume of the RBC/PLT dilution during the RBC/PLT measurement portion of each
cycle.
RBC/PLT Transducer Assembly
The 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:

The RBC/PLT Transducer — The transducer contains two chambers. The

mixing chamber on the left is used to mix 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 portion of each
cycle.
RBC/PLT Aperture Plate — This plate is inserted into a slot between the two
transducer chambers. A jewel containing the aperture is heat embedded into
the plate.
WBC Metering Assembly
The WBC Metering Assembly contains a precision-bore glass tube with a set of
optical detectors, one upper and one lower, mounted on it. It is used to meter a fixed
volume of WBC/HGB dilution during the WBC measurement portion of each cycle.
WBC Transducer Assembly
The WBC Transducer Assembly contains the fluidics and hardware required for
accurate measurement of the diluted white blood cells. The primary components of
this assembly are:
WBC Transducer — The transducer contains two chambers. The mixing

chamber on the left is used to mix the WBC/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 WBC measurement portion of each cycle.
WBC Aperture Plate — This plate is inserted into a slot between the two
transducer chambers. A jewel containing the aperture is heat embedded into
the plate.

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
An interference filter used to obtain the ICSH recommended wavelength of
540 nm
A photodetector for measuring the light transmitted
Lower Left Side Panel

The components on the Lower Left Side Panel of the analyzer are depicted in Figure
1-3. The functional description of each component follows.
Figure 1-3 Lower Left Side Panel Components
Waste Sensor Connector
The waste-full sensor plug connects to the Waste Sensor Connector port. When the
electrical sensor is tripped, the <WASTE FULL> message is generated and the
READY status is inhibited until the situation is corrected. The analyzer interprets a
disconnected plug the same way as a full waste container. Therefore, if the waste is
routed to a drain, a dummy plug must be inserted in the connector.
Detergent Inlet Tube Connector
This color-coded (green) port is used to connect the Detergent inlet tube with its
associated cap, weighted end and label.

Diluent Inlet Tube Connector
This color-coded (red) port is used to connect the Diluent inlet tube with its
associated cap, weighted end and label.
HGB Lyse Inlet Tube Connector
This color-coded (blue) port is used to connect the WBC/HGB Lyse inlet tube with
its associated cap, weighted end and label.
Waste Outlet Tube Connector
This color-coded (black) port is used to connect the waste outlet tube.
Normally Closed Valves
The two Normally Closed Valves prevent the detergent and diluent from draining
down into the analyzer when the analyzer power is turned OFF.
Lyse Pump Assembly
The Lyse Pump Assembly consists of a rotor, tubing and pump tube holder. It
controls the volume of lyse reagent dispensed during each cycle. It also prevents the
drainage of lyse from the flow system when the power is OFF.
Syringe Assembly The Syringe Assembly contains two syringes.
Diluent Syringe - delivers a specific volume of Diluent to transport the blood to the
mixing chambers.
Sample Syringe - aspirates a specific volume of sample.

Rear Panel The components visible on the Rear Panel of the analyzer are depicted in
Figure 1-4. The functional description of each component follows.
Figure 1-4 Rear Panel Components
Fans Air intake fans cool the internal components of the analyzer. They are covered with
filters that are easily removed, as required, for routine cleaning.
Analyzer Power Connector
This receptacle is used to connect the main power cord to the analyzer.
Upper Right Side Panel

The components visible on the Upper Right Side Panel of the analyzer are depicted
in Figure 1-5. The functional description of each component follows.
Figure 1-5 Upper Right Side Panel

Analyzer Power Switch
This is the main power switch for the analyzer.
Reset Button This push button restarts the computer in the CELL-DYN 1600.
Brightness Control
This control adjusts the brightness of the video display screen.
Serial Interface Connector
This port is used to connect a serial connector to an optional external device that
accepts serial data in ASCII format.
Parallel Interface Connector
This port is used to connect the 25-pin printer cable from the graphics printer
supplied with the analyzer.
Ticket Printer Connector
This port is used to connect the 25-pin printer cable when the printer is used to
print data in a ticket format.
Reagent System
Introduction The Reagent System is formulated specifically for the CELL-DYN 1600 series
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 1600 series system is
tested at the factory using the specified reagents, and all performance claims are
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 32oF (0oC) may cause reagent layering that
changes the tonicity and conductivity of the reagents. If any reagent has been
frozen, it should not be used.
CAUTION When a reagent is changed, a normal background should be run to ensure that the
system is primed immediately prior to running any specimens.

1-9
9140214 Rev F — April 1996
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.
Diluent CELL-DYN Diluent is formulated to meet the following requirements:
• Act as the diluent for the WBCs, RBCs, PLTs and Hemoglobin
• Maintain the cell volume of each red cell and platelet during the count
and sizing portion of the measurement cycle
• Provide a conductive medium for impedance counting of cells and
platelets
• Provide acceptable background counts
Lytic Agent CELL-DYN Lytic Agent is formulated to meet the following requirements:
• Rapidly lyse the red blood cells and minimize the resultant stroma
• Alter the white cell membrane to allow the cytoplasm to slowly diffuse
and to allow the membrane to shrink around the nucleus and any granules
that may be present
• Convert hemoglobin to a modified hemiglobincyanide complex that is
measurable at 540 nm (The quaternary ammonium lysate participates as
a chromagen)
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 Hemoglobin measurement cycle
• Provide proper meniscus formation in both metering tubes and maintain
it during each run cycle
• Rinse both counting chambers, both metering tubes and the HGB flow
cell with minimal bubble formation
Enzymatic Cleaner
CELL-DYN Enzymatic Cleaner is formulated to effectively remove protein

build-up within the instrument.
1-10
9140214 Rev F — April 1996

Installation
Introduction Installation of the CELL-DYN® 1600 should be performed by an Abbott authorized

representative to ensure that all system components are functioning correctly and to
verify system performance. Installation procedures must be repeated if the analyzer
is moved from the original installation site.
NOTE Installation of the analyzer by an unauthorized or untrained person could result in

damage to the system and may void the warranty. Never attempt to install the system
without an Abbott authorized representative present.
The remainder of this chapter gives general requirements for a successful

installation. The installation procedures for the Closed Sampler are contained in the
CELL-DYN 1600CS Addendum.
Initial Preparation
Inventory The instrument is shipped from the factory as follows:
Analyzer
Accessories and the Accessory Kit
Graphics Printer
Ticket Printer (optional)
Reagents, Calibrator, and Controls necessary for installation.
Space Requirements Approximately four (4) linear feet of space is required on the countertop. Allow
sufficient space on the countertop, or below the instrument, for Diluent, Lyse, and
Detergent. Provide space below the instrument for the waste container (if one is
used).
Allow two (2) to four (4) inches of space behind and on the left side of the analyzer
for air flow. A constant circulating internal air stream is required to cool circuitry
and components whenever the power is. If possible, allow 24 inches of space
above and to either side of the instrument for service access.
Locate the instrument:
Away from direct sunlight.

Away from the path of a cooled or heated air outlet.
Far from a centrifuge, X-ray equipment, CRT, video terminal, computer or
copier.
Place the reagents on the same level or below the instrument.

9140214 Rev D— June 1993

Waste Requirements Allow room for a suitable waste container below the unit, or position the instrument
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. Be sure that the
waste outlet tube is secured in the drain hole. (Refer to Tube Installation for
installation instructions.)
Power Requirements Be sure that the system is located at the desired site before attempting any
connections. A grounded power outlet is required. A voltage regulator may be
necessary for optimum performance. Insert the power cord into the power cord
connector on the rear panel. Do not turn the power
ATTENTION Check all side and rear panel connectors for particles or foreign material that can
impair electrical contact when connections are made.

!
"" #""$ %"&'

"" #""$ ("&'
% "%
%$ ("&'

% #%
)%$ %"&'

)"
"
%"$ %"&'
The CELL-DYN 1600 is designed for low power consumption. The instrument
automatically performs an initialization cycle whenever power is turned During
the daily routine operating period, power should be left .

9140214 Rev D— June 1993

Printer Installation
Overview Remove the printer(s) from the shipping container and visually inspect for damage.
Find a suitable location adjacent to the analyzer. Be sure that the printer power
switch is in the ** position. The printer manuals should be stored in a convenient
location.
NOTE If the printer(s) is placed on top of the instrument, be sure that the paper does not
restrict air flow to the rear analyzer fans.
When used with the CELL-DYN 1600, the graphics printer prints graphic reports
and the ticket printer prints individual preprinted tickets. Depending on the output
desired, one or both printers may be connected to the analyzer.
CELL-DYN 1600 Interface Panel (Right Side)
Follow installation instructions carefully to be sure that the printer(s) is connected to

the correct port on the analyzer. 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(s).
Graphics Printer 1. Assemble the printer as directed in the printer manual.
2. Make sure that the printer power switch is **. Plug the power cord into the
printer. Do not plug the other end into a grounded outlet until you are ready
to power .
3. Locate the ribbon cable in the accessory kit and attach it to the connector
labeled + , (See Figure 2-1.) Attach the cable's other end to
the printer's rear panel connector. Refer to the printer's operation manual for
detailed installation procedures.

9140214 Rev D— June 1993

4. Install the ribbon cartridge as directed in the printer manual.
5. Load the paper as directed in the printer manual.
6. Plug the power cord into a grounded outlet and turn the power switch .
Self-Test Printouts Run self-test printouts before using the printer for the first time. These self-tests may
be run any time to verify proper printer operation.
NOTE The CELL-DYN 1600 software automatically controls and adjusts most print
conditions for the graphics printer, including page width. Occasionally, a few
settings may need to be changed in the printer's software for correct operation. 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 the
Abbott Customer Support Center for assistance.
Ticket Printer The ticket printer is used to print result data on 3.25-inch wide, multiple copy,
carbon or carbonless tickets. Each ticket is automatically fed into the printhead,
clamped, printed, and fed out of the printhead. A form sensor ensures that each ticket
is properly positioned prior to clamping.
1. Assemble the printer as directed in the printer manual.
2. Make sure that the printer power switch is **. Plug the power cord into the
printer. Do not plug the other end into a grounded outlet until you are ready
to print.
3. Attach the cable for the ticket printer to the connector labeled + -.
+. which is just below the $$.+.*$ . on the analyzer.
(See Figure 2-1.) Attach the cable's other end to the printer's rear panel
connector. Refer to the printer manual for detailed installation procedures.
4. Install the ribbon cartridge as directed in the printer manual.
ATTENTION An improperly installed ribbon cartridge can cause the ribbon to jam in the printhead
drive mechanism.
Self-Test Printouts Plug the power cord into a grounded outlet and turn the toggle switch . Insert a
ticket into the guide. A self-test mode checks operation and prints self-test data at the
completion of the check.

9140214 Rev D— June 1993

Tube and Diluent Syringe Installation

Reagent and Waste Tubes
1. Locate the reagent inlet tubes in the accessory kit.
2. Inspect each tube carefully for damage or cracks.
Lower Left Side Panel
3. Attach the non-weighted end of the tube with the Red Diluent label to the
Red side panel connector. Wipe the outside of the tube with a damp lint-free
tissue and place the weighted end into the container of
CELL-DYN Diff-Screen Diluent. Secure the cap. Place the container on the
same level or lower than the unit.
4. Attach the non-weighted end of the tube with the Green Detergent label to
the Green side panel connector. Wipe the outside of the tube with a damp
lint-free tissue and place the weighted end into the container of CELL-DYN
Diff-Screen Detergent. Secure the cap. Place the container on the same level
or lower than the unit.
5. Attach the non-weighted end of tube with the Blue Lyse label to the Blue
side panel connector. Wipe the outside of the tube with a damp lint-free
tissue and place the weighted end into the container of CELL-DYN
Diff-Screen Lyse. Secure the cap. Place the container on the same level or
lower than unit.

9140214 Rev D— June 1993

6. Attach the Waste Outlet Tube to the Black side panel connector. Place end of
the tube with the cap and sensor into the waste collection container. Secure
the cap. Or, remove the cap from the tube and place the tube into a drain
suitable for collection of waste with possible biological and chemical
hazard. Be sure that the tube is secured to the drain hole.
Locate the Waste Full Sensor plug attached to the cap's electrode wires.
Insert the plug into the /$. connector located on the left panel. When
the waste tube is placed directly into a drain, insert a "dummy" plug into the
/$. connector. If a "dummy" plug is not inserted, the /$.*0
alert is activated.
Normally Closed Valves
The tubes for the normally closed valves on the left panel were removed from the
valves for shipment.
1. Locate the lower normally closed valve (black octagon), just above the Lyse
Pump Assembly, and the diluent inlet tube. Carefully stretch the tube
between your hands and insert it into the valve opening. Work the tube gently
back and forth until it is completely inserted into the valve.
2. Locate the upper normally closed valve (black octagon) above the diluent
valve and the detergent inlet tube. Carefully stretch the tube between your
hands and insert it into the valve opening. Work the tube gently back and
forth until it is completely inserted into the valve.
Lyse Tube Installation in Pump
1. Locate the inlet/outlet tube connection panel, lyse pump rotor and lyse tube.
Locate the lyse pump tube holder directly below the pump rotor and tube
stops on both sides of rotor. The tube stops prevent the lyse tube from
moving during lyse pump rotor action.
2. Press down on the tube holder at portion closest to the front panel. (Refer to
Figure 2-2.) Hold the tube holder down and insert the lyse tube under the
rotor and into the tube stops — confirm that tube is not crimped or pinched.
Release the tube holder.

9140214 Rev D— June 1993

Diluent Syringe Installation
Before shipment, the diluent syringe is removed, cleaned and reinstalled in the
dispenser. It is not attached at the luer lock fitting of the 3-way directional valve. A
protective cap is attached to the luer lock fitting.
1. Slide the plastic cover on

the left side panel towards
the rear to gain access to
the diluent syringe.
2. Remove the thumb nuts on

the syringe holder block
and remove the front
section of the holder
block. Save the thumb nuts
and the block.
3. Locate and unscrew the

protective cap attached to
the luer lock fitting for
shipment.
4. Extend the barrel of the

Diluent Syringe
syringe until it touches the
luer lock fitting. Secure
the syringe onto the luer lock fitting by turning it counterclockwise (as
viewed from above) until it is finger tight — do not overtighten.
5. Replace the front section of the syringe holder block and secure it with the
two (2) thumb nuts removed in step 2 above. Tighten the thumb nuts finger
tight only.

9140214 Rev D— June 1993

Flow Panel Inspection and Installation

Upper Front Cover Removal
The upper front cover must be removed to gain access to the flow panel normally
closed valve. The diluent tube, normally inserted in this valve, was removed for
shipment. To ensure correct system operation, this tube must be completely inserted
before the power is turned on.
Upper and Lower Front Cover Removal
1. Locate, on the lower edge of the upper front cover, the screw used to securely
attach the cover during shipment. Remove the screw and save it. The screw
must be reinstalled to move or ship the instrument.
2. Grasp the lower portion of upper front cover and pull it out - towards you -
about 1 inch; then pull it up until it releases from the upper mount brackets.
3. To remove the cover completely, detach the ground wire at the connector
attached to analyzer's main frame. Remove the cover.
NOTE Performance may be affected if the ground wire is not reconnected before cover is
reinstalled.

9140214 Rev D— June 1993

Lower Cover Removal
1. Locate the thumb screw on upper left side of lower front cover; turn it
counterclockwise 2 to 3 turns to loosen it. Slide the cover to your left about 1
inch until the right side is free of the screen bezel cover and remove the
thumb screw.
2. Raise the cover about 1 inch to release the bottom edge from the lower mount
brackets.
3. Pull cover out and set it aside.
Flow Panel Inspection
ATTENTION The diluent tube MUST be installed before the power is turned for the analyzer
to operate correctly.

1. Locate, on the upper left portion of the flow panel, the normally closed (black
octagon) valve, and the removed diluent tube. See Figure 2-5.
2. Carefully insert the diluent tube into the valve opening. Work the tube gently
back and forth until it is completely inserted into the valve. Unless this tube
is securely seated, the message
!" may be displayed and
the flow system will not function properly.
3. Confirm the tube connections and fittings on BOTH ends of the tube.
4. Inspect the flow panel components: each dilution bath and aperture plate, all
tubes, connectors, valves, etc. for damage.

9140214 Rev D— June 1993

Data Diskette Installation

1. Locate the two 3.5" diskettes taped to the inside of the left side panel
compartment.
2. Remove the protective cardboard in the floppy disk drive. Save the
cardboard insert and spare diskette.
3. Position the diskette so that the metal edge is inserted first and the diskette
label is up and readable. Insert the diskette into the drive on the side of the
instrument
Power On The CELL-DYN 1600 is designed for low power consumption. Whenever the power
is applied, an initialization cycle is performed to check system status, to place
mechanical components in the "home" position, and when acceptable, to place the
unit in an initialized state.
Power On and Initialization
1. Confirm that the power plugs for the analyzer and the printer(s) are inserted
into the line voltage regulator or a grounded power outlet.
2. Move the printer's power switch to . Confirm that the graphic printer
paper is installed and feeding correctly.
3. Move the analyzer's power switch to . The screen illuminates within 15 to
30 seconds and the statement #

#
$
%" appears in
the upper center screen System Status box. When the cycle is complete, the
message +++$+1.2 displays in the Status Box.
At initial installation, before activating an Auto-Startup cycle, allow the analyzer to

warm up for 5 minutes. System setup can be performed at this time.
NOTE An Auto-Startup cycle actuates whenever the &'(key is pressed and

+++$+1.2 or $234 appears in the System Status box. Each Auto-Startup
cycle primes the flow system with reagents and checks the background.
Operator ID Number Entry
A two-digit identification number for the current operator is entered only when the
5$+5.0 is displayed. At the completion of each Power On Initialization cycle,
the 5$+5.0 is displayed with the cursor flashing at the 6 .$+2>
field.

9140214 Rev D— June 1993

Enter the two digit identification number using the numeric keys on the keypad
below the screen. The Operator ID can be entered ONLY when the 5$+5.0 is
displayed.
NOTE An Operator ID is not required for system operation.
The Sequence Number
The Sequence Number display below the 6 .$+27 field automatically

increments by one each time a Run cycle is actuated by pressing the touch plate. The
sequence number cannot be entered or changed by the operator.
Setup System Operation

The .0 5.0 is used to review and change options for data format to output
devices such as printers and computers. The units of measure display and print
format options are also selected from this screen.
The function is active.

** The function is not active.
Any number displayed in place of or ** can be changed using the numeric
keys on the keypad to enter a new number within the stated limits. For example, the
number preceding the "line-feeds per printer page" statement applies to the graphic
printer and indicates the current line-feed selection.

9140214 Rev D— June 1993
Installation Chapter 2
Main SETUP MENU Screen
The numbers on the main SETUP MENU screen shown below correspond to the
following numbered options:
Table 2-2
Main SETUP MENU Screen
=================================================
1 ON X-B Moving-Average Program
2 OFF Automatic Increment of Specimen I.D. Number
3 ON Print Histograms
4 OFF Print MPV, PCT, PDW
5 OFF Print ALERTED LYM/%L, *MID/%M, GRAN/%G Results
6 OFF Print ALERTED PLT Results
7 OFF Automatic Ticket Printout
8 ON Automatic Graphics Printout
9 66 Line-Feeds per Form-Feed on Graphics Printer (01 TO 99)
10 OFF Automatic Transmission to Computer
11 OFF Automatic Transmission of Histograms
12 0.3 Transmission Time-Out (0.1 TO 9.9 Seconds)
13 1 Units of Measure:
1 = Factory (United States)
2 = SI Units
3 = SI Units (HGB/MCHC in MMOL/L; MCH in FMOL)
4 = SI Units (HCT/PCT in %)
=================================================
1. X-B Moving Average Program — When this option is enabled, the X-B
Moving Average Program is activated.
2. Automatic Increment of Specimen ID Number — When this option is enabled,

the specimen ID number entered will automatically increment by one for the
next sample, unless a new ID number is entered.
3. Print Histograms — When this option is enabled, the WBC, RBC, and PLT
histograms are printed with each specimen report.
4. Print MPV, PCT, PDW — When this option is enabled, the MPV, PCT, and
PDW results are printed with each specimen report.
NOTE Clinical significance has not been established for PCT and PDW; therefore, they are
not reportable.

9140214 Rev DC June 1993

5. Print ALERTED LYM/%L, *MID/%M, GRAN/%G Results — When this

option is enabled, the results for these flagged parameters are printed on the
specimen report.
6. Print ALERTED PLT Results — When this option is enabled, the results for
a flagged PLT are printed on the specimen report.
7. Automatic Ticket Printout — When this option is enabled, a specimen report

is automatically printed on the ticket printer.
8. Automatic Graphic Printout — When this option is enabled, a specimen

report is automatically printed on the graphics printer.
9. Line-Feeds per Form-Feed on Graphics Printer (01 to 99) — When the

entered number is 66, one report is printed per 8.5" by 11" sheet of paper. To
print two reports per sheet of paper, enter 33 and align the paper in the printer
so that the top edge is even with the ribbon.
10. Automatic Transmission to Computer — When this option is enabled, the

specimen report is automatically transmitted to a host computer.
11. Automatic Transmission of Histograms — When this option is enabled, the

WBC, RBC, and PLT histograms are automatically transmitted to a host
computer.
12. Transmission Time-Out (0.1 to 9.9 Seconds) — This option sets the amount
of time (in seconds) the analyzer will attempt to send a report. If the
transmission fails, the analyzer will “time-out.”
13. Units of Measure — This option sets the appropriate units of measure for the
results on the specimen report.

9140214 Rev D— June 1993

To Review or Change Setup Status
1. At the 5$+5.0, press &) (. The .0 5.08!.
Review and/or change any selection on the .0 5.0 screen.
2. ARE THE SELECTIONS ACCEPTABLE?
YES Go to the Date/Time Setup procedure.
NO Use the #* keys on the keypad to move the cursor to the
selection requiring change.
Press to toggle between or**
OR
Type the new number that is within the limits shown for the
selection. Repeat this process until all required changes are
complete. Go to the Date/Time Setup procedure.
Keypad Setups
Date/Time Key Date and time are maintained by an internal battery-powered clock. The current date
and time display in the upper right of the screen. The multiple date format option
allows the operator to select the desired date format.
Date re-entry is not required when a new format option is selected and the
current date is correct.
The hour clock cannot differentiate between AM and PM. To avoid
confusion, use a 24-hour clock. (For example, 1 for 1 AM and 24 for 12
midnight.)
Change the Date and Time
1. From the .0 5.0, press &#+

(.
The .0 2$.9+5.5.0 displays.
2. IS THE DISPLAYED DATE FORMAT CORRECT?
YES Go to step 3.
NO Type the number for the desired date format option.

Go to step 3.

9140214 Rev D— June 1993

3. IS THE DISPLAYED DATE AND/OR TIME CORRECT?
YES Press &''( to return to the.0 5.0.
The date entry is not required when the date is correct and only
the format requires change.
NO Enter the date (using MM/DD/YY) and/or the time (using a

24-hour clock).
Repeat the process until all required changes are complete.
NOTE A slash and/or colon must be entered when setting the date or time.
4. Press &''( to return to the .0 5.0.
Patient Range Entry Key
Upper and lower alert limits for patient specimen results can be entered, reviewed,
and changed as required via the & #'#%'!( key. Entered values are
used to flag patient specimen results for each of the 18 parameters.
When a parameter result exceeds an entered limit, each affected result displays in
inverse video (backlit) and prints underlined on the graphic printer with an "*"
preceding on the ticket printer. Entered limits print at the top of each displayed or
printed Data Log summary page.
To Change Patient Range Entries
1. At the .0 5.0 press & #'#%'!(.

The $+.$:..4 screen displays.
2. ARE THE LIMITS ACCEPTABLE?
YES Press &''( to return to the.0 5.0.
NO Use the #* keys to move the cursor to the numbers that are to
be changed, and type the new limits.
Repeat this process until all the limits are acceptable.
The cursor advances automatically to the next field if the value

entered contains the maximum number of digits for the field. If
the number contains less than the maximum number of digits,
press to move the cursor to the next field.
Press &''( to return to the .0 5.0.

9140214 Rev D— June 1993

Reagents Log Key &'#%),%( displays a new screen and labels allowing the operator to select
a specific reagent type: diluent, detergent, or lyse. Additional screens and labels
allow the operator to enter, review or print: container size, lot number, expiration
date, and open date for up to ten containers per reagent.
To Complete the Reagents Log
1. At the .0 5.0, press &'#%),%(.

The .. .$:. screen displays.
2. Select a Reagent Log by pressing the appropriate keypad:
&
(, &!)(, or &'%(
The selected log screen displays with the cursor positioned on the first blank
line of the log.
3. Enter the Size, Lot#, Expiration Date, and Open Date. This screen only
accepts numbers in the fields on the screen.
Repeat this process until all entries for the reagent log are complete. If the
value entered into a field contains less than the maximum number of digits
allowed for the field, press . The cursor moves to the next field.
4. Press & '

( to print the log.
5. Press &''(.
Repeat steps 2-4 for each reagent type.
OR
To return to the .0 5.0, press &''(, and then &) (.
Control File Setup Key
The Control File Setup function allows the operator to select a specific control file to
enter, review, change, or print numeric data pertaining to selected file(s), e.g., lot
number, expiration date, printed insert mean and limits, etc. Any run result
exceeding these entered limits is displayed in inverse video and underlined on the
graphic printout. The information is printed with an "*" on the ticket printer.

9140214 Rev D— June 1993

To Select a Specific Control File
1. At the .0 5.0, press &

) (
The message '))),-!" displays in the Status Box.
2. Press the corresponding key for the type of control to be updated:

&,.,',(, &,'#,',(, or &/
%/,',(.
The *+..0 screen displays.
3. IS THE LOT NUMBER ENTRY ACCEPTABLE?
YES Press .

Go to step 4.
NO Enter the lot number (up to nine digits) and press .
The data is stored and the cursor advances to the next field.
This field accepts only numeric data. If the lot number is less than
nine digits, press to advance the cursor.
4. IS THE EXPIRATION DATE ENTRY ACCEPTABLE?
YES Press 0

Go to step 5.
NO Type the expiration date (using MM/DD/YY) from the control

vial or assay sheet.
5. IS THE WESTGARD RULE SELECTION ACCEPTABLE?
YES Go to step 6.
NO Set the cursor at the rule requiring change, and press .
Repeat this process until all rule selections are acceptable.

Go to step 6.
6. REVIEW RANGE OR MEAN/LIMITS?
YES Press &'#%( or &#+

)(. The screen for the selected
control file displays.
Go to step 7.
NO Press &''( to return to *+..0 5.0.

9140214 Rev D— June 1993

7. ARE THE VALUES ACCEPTABLE?
YES Go to step 8.
NO Use the #* keys to move the cursor to the first value to be
changed and type the new value.
If the value has less than three digits, press the key to store
the data and advance the cursor.
Repeat this process until all values are entered and acceptable.
Go to step 8.
8. IS A PRINTOUT REQUIRED?
YES Press & '

(.
NO Go to step 9.
9. IS ANOTHER CONTROL SETUP REQUIRED?
YES Press &''( twice to return to the *+..0 5.0.
Repeat steps 2-9 for each control as required.
NO Press &''( twice.

Press &) ( to return to .0 5.0 screen.
Replicate File Setup Key
Nine QC files, labeled 1 to 9, are designated for use with replicate "control"
specimens, such as:
retained patient specimens

overlapping control lots
different shift control specimens
different brand of controls
precision check specimens, etc.
Using &'
) (1 values for each parameter (up to 18), with mean/limits,
or upper and lower range, can be entered for each file. In addition, data can be
copied from a replicate file into a designated control file.
NOTE Prior to data copy, any run data in the designated control file must be purged using
& '%( for that control.

9140214 Rev D— June 1993

To Enter Flag Information
1. At the.0 5.0, press &'

) (.
The ''
#
2" message displays in the Status Box.
2. Enter the replicate file number.

The . + $.;;*+..0 screen displays.
3. IS THE LOT NUMBER ENTRY ACCEPTABLE?
YES Press .

Go to step 4.
NO Type lot number, or other identifier, up to nine digits. Press

to store data and advance the cursor.
NOTE This field accepts only numeric data. If the lot number is less than 9 digits, press
to advance the cursor.
4. IS THE EXPIRATION DATE ENTRY ACCEPTABLE?
YES Press 0

Go to step 5.
NO Type the expiration date (using MM/DD/YY) from the control

vial or assay sheet.
5. IS THE WESTGARD RULE SELECTION ACCEPTABLE?
YES Go to step 6.
NO Set the cursor at the rule requiring change. Press .
Repeat this process until all rule selections are acceptable.

Go to step 6.
6. REVIEW RANGE OR MEAN/LIMITS?
YES Press &'#%( or &#+

)( to display the screen for the
selected control file.
Go to step 7.
NO Press &) ( to return to .0 5.0.

9140214 Rev D— June 1993

YES Go to step 8.
NO Use the #* keys to move the cursor to the first value to be
changed and type the new value.
If the value contains less than three digits, press the key to
store the data and advance the cursor.
Go to step 8.
NOTE Refer to the Quality Control chapter for the established Replicate Specimen Mean
Values.
8. IS A PRINTOUT REQUIRED?
YES Press & '

(.
NO Go to step 9.
9. IS ANOTHER REPLICATE FILE REQUIRED?
YES Press &''(.

Repeat steps 2-9 for each file, as required.
NO Press &''( then &) ( to return to .0 5.0

screen.

9140214 Rev D— June 1993

X-B File Setup Key Calculated data for each batch (20 specimens) is compared to an established X-B
target and limits to determine if the X-B batch data is acceptable. To eliminate bias
from grossly abnormal specimen results, data acceptance limits are set, via the <3
*+..0 screen, to automatically exclude these specimens from the program.
To Use the X-B Function
1. At the .0 5.0, press &34) (.
The <3*+..0 screen displays, and the cursor is on the first MCV
limit.
YES Press &) ( to return to .0 5.0 screen.
NO Move the cursor to the first value to be changed and type the new
value.
If the value contains less than 3 digits, press the key to
store the data and advance the cursor.
3. Press &) ( to return to .0 5.0 screen.
Auto-Startup Cycle
The Auto-Startup cycle activates anytime the &'( key is pressed and either
+++$+1.2 or $234 displays in the Status Box. The cycle is designed to
prime the flow system and check the background before specimens are run. Upon
completion of the cycle, the 0 screen displays with the background check results.
A background is run in order to monitor the quantity of particles present in reagents
and the flow system.

9140214 Rev D— June 1993

At installation, perform multiple run cycles to thoroughly prime and purge any
particles from the flow system. During each cycle, the computer monitors the time
required for each measurement, referred to as the count time. A value for this time
displays in seconds to the right of the histograms. The count time is used to monitor
fluid flow, to detect the presence of partial restrictions in either aperture and/or the
presence of air in either metering tube. Cell sizing can be affected by either of these
conditions.
To Actuate the Auto-Startup Cycle
The message #

1

#
$" must be displayed in the Status Box
of the 5$+5.0 screen.
1. To start the cycle, press &'].
2. The message '1'#!"displays in the Status Box when the

cycle is complete.
3. Press &)
! ( to display the next screen.
4. Press &,'#4#-%',(. The 5$+05.0 displays.
5. Press the touch plate to start the cycle - no specimen is required.
6. Repeat step 5 until acceptable background and count time data (see
Table 2-3) are obtained for three consecutive cycles.

)
$ 3=88 2
3=8
/3 ""%-90 %"">""

3 ""%590 ?"">""
&:3 ""
98
""-90
This completes initial installation power on, system setup, and initial prime
procedures. Calibration is the next procedure when installing an analyzer.

9140214 Rev D— June 1993
Chapter 3 Principles of Operation
Principles of Operation
Introduction The principles that the CELL-DYN® 1600 uses to measure, count, and calculate the
hematologic parameters are discussed generally in the first section of this chapter. The
parameters are discussed individually and a detailed explanation of the theory used for
parameter derivation in each of two methods is given in the last section.
The two independent measurement methods used in the CELL-DYN 1600 are:
the impedance method for determining the WBC, RBC, and PLT data
the modified cyanmethemoglobin method for determining the HGB
During each instrument cycle, the sample is aspirated, diluted and mixed before the
measurements for each parameter are performed.
Sample Analysis Cycle Overview

Aspiration The CELL-DYN 1600 uses the open sampler mode to aspirate 30 microliters of
whole blood from a collection tube that has been opened and held under the
specimen probe.
Dilution A 7.5 mL volume of diluent is added in the pre-mix cup to achieve a ratio of 1:251.
Whole blood pre-diluted with diluent to a ratio of 1:251 can also be used as a sample
in the Pre-Dilute mode (40 )L of sample to 10 mL of diluent).
The diluted sample is then divided into two samples.
100 microliters of the 1:251 sample dilution are aspirated and mixed with an
addition of 5 mL of diluent in the RBC/PLT dilution bath to a ratio of
1:12801. The 1:12801 dilution is used to analyze the red cell and the platelet
parameters.
The remainder of the 1:251 dilution is mixed with 1.0 (± 0.25) mL of lyse
reagent in the WBC dilution bath. The lyse reagent changes the membrane of
each red cell causing cytoplasm and hemoglobin to be quickly released. The
red cell membrane (ghost) that remains is less than 2 femtoliters.

9140214 Rev E—February 1994
Principles of Operation Chapter 3
The lyse reagent also compresses the membrane of each white cell
(leukocyte). This causes cytoplasm to slowly diffuse from the cell as the
membrane shrinks around the nucleus and any cytoplasmic granules that may
be present. This dilution is used to measure the number and modified size of
the white cells and the amount of hemoglobin released.
Volumetric metering is used in both the WBC dilution bath and the RBC
dilution bath to ensure that a precise amount of diluted specimen is measured
during each count cycle.
WBC Analysis Electrical impedance is used to count the white blood cells as they pass through the
aperture in the WBC transducer. As each cell is drawn through the aperture, a
change in electrical resistance occurs generating an equivalent voltage pulse. The
number of pulses sensed during each cycle corresponds to the number of white cells
counted. The amplitude of each pulse is directly proportional to the volume of the
cell it represents.
The CELL-DYN 1600 uses electronic sizing to determine three distinct white cell
subpopulations. Cells correlating to lymphocytes are included in the small cell
subpopulation. Cells correlating to granulocytes are included in the large cell
population. The remaining cells correlating to monocytes, eosinophils, basophils,
blasts, and other precursor white cells are generally included in the mid-size cell
population.
RBC/PLT Analysis
The 1:12801 dilution is pulled through the aperture of the transducer bath where
electrical impedance is used to count the red blood cells and platelets as they pass
through the aperture.
Hemoglobin Analysis
After the WBCs have been counted and sized, the remainder of the lysed dilution is
transferred to the HGB flow cell. In the flow cell, the CELL-DYN 1600 measures
the ability of the dilution to absorb light at a wavelength of
540 nm. The result is reported as a measured weight per volume of whole blood; for
example, HGB xx.x g/dL refers to xx.x grams of hemoglobin per deciliter of whole
blood.
Results Displayed All data are transferred to the CELL-DYN 1600 computer for processing. Results are
displayed on the video display monitor RUN MENU. Size distribution data for lyse-
modified WBCs and subpopulations, for RBCs and PLTs are displayed as
histograms. The corresponding results from each count are displayed to the left of
each histogram.

MCV, HCT, RDW Determination
The CELL-DYN 1600 determines the mean cell volume (MCV) from the red cell
size distribution data and reports it in fL. The result for hematocrit is calculated from
the red cell count and the mean cell volume value using the following formula:
HCT (hematocrit) = (RBC * MCV) / 10
Red cell distribution width (RDW) is the coefficient of variation of red cell
heterogeneity determined from the red cell size distribution data.
MPV, PCT, PDW Determination
An algorithm is used to analyze the platelet histogram to obtain the mean platelet
volume (MPV). Each MPV xx.x fL result is reported directly in femtoliters. A result
for plateletcrit is calculated from the platelet count and mean platelet volume as
follows:
PCT = (PLT * MPV) / 10
Each PCT x.xx mL/L result is reported as milliliters per liter. Platelet distribution
width (PDW) is the geometric standard deviation (GSD) of the platelet size
distribution. Each PDW xx.x 10(GSD) result is derived from the platelet histogram
data and is reported as 10(GSD).
MCH and MCHC Determination
Values for the mean cell hemoglobin (MCH) and the mean cell hemoglobin
concentration (MCHC) are calculated automatically whenever appropriate
parameters are measured, e.g., red cell count, hematocrit, and hemoglobin. The
following formulas apply:
MCH (mean cell hemoglobin) = (HGB/RBC) * 10
MCHC (mean cell hemoglobin concentration) = (HGB/HCT) * 100
Each MCH xx.x pg result is reported in picograms. Each MCHC xx.x g/dL is
reported as grams per deciliter.
Data Storage Up to 320 run cycles are automatically stored in a Data Log on the system diskette.

Instrument Rinsed After each run cycle, each element of the instrument is rinsed.
The open sample specimen probe is rinsed internally and externally

with diluent.
The WBC dilution bath is rinsed with diluent.
The RBC/PLT dilution bath is rinsed with diluent.
The HGB flow cell is rinsed with detergent.
WBC Measurement Process

Overview The WBC impedance method is used for the determination of WBC data. Cells are
counted and sized as they pass through the aperture of the WBC transducer.
Electrical Impedance Measurements
WBCs are counted and sized by the Aperture Impedance method. This method is
based on the measurement of changes in electrical resistance produced by a particle
suspended in a conductive diluent as it passes through an aperture of known
dimensions. An electrode is submerged in the liquid on both sides of the aperture to
create an electrical pathway.
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
passed through the aperture. The amplitude of each pulse is essentially proportional
to the volume of each particle.
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.
Volumetric Metering
An accurate 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 1600 uses the Volumetric Metering process to regulate the count cycle
and to make sure that a precise volume of sample is analyzed for the measurement.
The WBC Metering Assembly contains a precision-bore glass tube fitted with two
optical detectors. This tube ensures that a precise amount of diluted specimen is
measured during each count cycle. The exact amount is determined by the distance
between the two optical detectors.

Detergent is used to create a meniscus in the metering tube. 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 detector to the lower detector is called the
Count Time and is measured in seconds. This is displayed on the RUN MENU. The
computer monitors the count time to detect any 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 RUN MENU displays
the message <CLOG> or <FLOW ERROR>, and no WBC and differential data are
displayed. A Clog indicates the flow was too slow, most likely caused by debris in
the aperture. Flow errors indicate the flow was too fast, often caused by bubbles in
the metering tube.
WBC Measurement
The 1:251 WBC/HGB dilution is delivered to the WBC dilution bath where it is
bubble mixed with 1.0 (± 0.25) mL of lyse reagent. A metered volume of the lysed
sample is drawn through the aperture by vacuum. The WBCs are counted by
impedance. If the pulse generated is above the WBC lower threshold, it is counted as
a WBC.
The von Behrens plate located in the WBC transducer counting chamber minimizes
the effect of recirculating cells. As cells exit from the aperture, they tend to swirl
around and may re-enter the sensing zone and be counted a second time. This causes
the counts to be falsely elevated.
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 is automatically
corrected for coincidence passage loss.
WBC Parameters
WBC Histograms The WBC data are plotted in a histogram format with the relative number of cells on
the Y axis and the WBC size distribution data on the X axis. Results of each count
are displayed to the left of the histogram on the RUN MENU.

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 # K / )L
LYM # K / )L and %
GRAN # K / )L and %
MID # K / )L and %
RBC/PLT Measurement Process

Overview The impedance method is used for the determination of RBC and PLT data. Cells are
counted and sized as they pass through the aperture of the RBC/PLT transducer.
Electrical Impedance Measurements
RBCs and PLTs are counted and sized by the Aperture Impedance method. This
method is based on the measurement of changes in electrical resistance produced by
a particle suspended in a conductive diluent as it passes through an aperture of
known dimensions. An electrode is submerged in the liquid on both sides of the
aperture to create an electrical pathway.
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
passed through the aperture. The amplitude of each pulse is essentially proportional
to the volume of each particle.
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 is automatically
corrected for coincidence passage loss.

Volumetric Metering
An accurate 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 1600 uses the Volumetric Metering process to regulate the count cycle
and to make sure that a precise volume of sample is analyzed for the measurement.
The RBC/PLT Metering Assembly contains a precision-bore glass tube fitted with
two optical detectors. This tube ensures that a precise amount of diluted specimen is
measured during each count cycle. The exact amount is determined by the distance
between the two optical detectors.
Detergent is used to create a meniscus in the metering tube. 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 detector to the
lower detector is called the Count Time and is measured in seconds. This is
displayed on the RUN MENU. The computer monitors the count time to detect any
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 RUN MENU displays the message <CLOG> or <FLOW
ERROR>, and no RBC/PLT and differential data are displayed. A Clog indicates
the flow was too slow, most likely caused by debris in the aperture. Flow errors
indicate the flow was too fast, often caused by bubbles in the metering tube.
RBC/PLT Measurement
The 1:12801 RBC/PLT dilution is delivered to the RBC/PLT dilution bath where it
is bubble mixed. A precise volume of the diluted specimen is drawn through the
aperture by vacuum. The RBCs and PLTs are counted by impedance. If the pulse
generated is above the PLT lower threshold, it is counted as a PLT. If the pulse
generated is above the RBC lower threshold, it is counted as an RBC.
The von Behrens plate located in the RBC/PLT transducer counting chamber
minimizes the effect of recirculating cells. As cells exit from the aperture, they tend
to swirl around and may re-enter the sensing zone and be counted a second time.
This causes the counts to be falsely elevated.

RBC Parameters
RBC Histograms The RBC data are plotted in a histogram format with the relative number of cells on
the Y axis and the RBC size distribution data on the X axis. Results of each count
are displayed to the left of the histogram.
RBC Count The RBC count is measured directly. The number of RBCs is expressed as follows:
RBC = # M / )L
MCV The Mean Cell Volume 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 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 red blood
cell count and the mean cell volume as follows:
HCT = (RBC * MCV) / 10
MCH The Mean Cell Hemoglobin is the average amount of hemoglobin contained in the
red blood cell expressed as picograms. The MCH is calculated from the RBC and
HGB as follows:
MCH = (HGB/RBC) * 10
MCHC The Mean Cell Hemoglobin Concentration 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) * 100
RDW Red Cell Distribution Width is a measure of the heterogeneity of the RBC
population. The CELL-DYN 1600 reports RDW as a percent coefficient of variation.
The RDW is derived from the RBC histogram.
RBC Flagging Refer to the Operational Messages and Data Flagging section of this chapter for
RBC Flagging Information.

PLT Measurement
Introduction Pulses counted in the RBC/PLT dilution between 1 and 35 fL are included in the
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 averaged. The PLT data are plotted as a
histogram. An algorithm analyzes the histogram to eliminate interference and thus
determine the lower and upper thresholds for the count.
If no interference is detected, the lower and upper thresholds are set at 2 and
35 fL, respectively. If interference is detected, the thresholds float to determine the
best separation between the interference and the PLT population. The lower
threshold floats in the 1 - 3 fL region, and the upper threshold floats in the 15 - 35 fL
region. Once the thresholds have been determined, the PLT count is derived from the
data between them.
Interference in the upper threshold region is generally caused by microcytic RBCs.

Therefore, after the PLT upper threshold has been determined, the data between it
and the RBC lower threshold are re-evaluated. If the PLT upper threshold is less than
35 fL, the count above it (but less than the RBC lower threshold) is added to the
RBC count.
If the interference in either threshold region exceeds a predetermined limit, the PLT
count is flagged accordingly. The flags are discussed in the last section of this
chapter.
PLT Parameters
PLT Histogram The PLT data are plotted in a histogram format with the relative number of cells on
the Y axis and the PLT size distribution data on the X axis. Results of each count are
displayed to the left of the histogram.
PLT Count The Platelet 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 = # K / )L
MPV The Mean Platelet Volume is derived from the PLT histogram after the PLT count
has been determined. The MPV is expressed in femtoliters.

PCT The Plateletcrit is the product of the PLT and MPV and is analogous to the
hematocrit. It is expressed in percent and is calculated as follows:
PCT = (PLT * MPV) / 10
PDW Platelet Distribution Width is a measure of the heterogeneity of the PLT population.
It is expressed as a geometric standard deviation.
NOTE PCT and PDW are not reportable.
PLT Flagging Refer to the Operational Messages and Data Flagging section of this chapter for PLT
flagging information.
Hemoglobin Measurement
Overview The modified cyanmethemoglobin method is used for the colorimetric determination
of hemoglobin. A sample of the lyse diluted sample from the WBC dilution bath is
used for the HGB measurement. A low-energy LED is used as the light source. A
filtered photodetector with a wavelength of 540 nm measures the transmitted light.
Hemoglobin Measurement Process
The Lytic Agent lyses the diluted red blood cells and converts the hemoglobin that is
released to a cyanide-containing pigment. After the WBC 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 exit the flow cell 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. After the hemoglobin reading has 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.
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.

HGB Flagging Refer to the Operational Messages and Data Flagging section of this chapter for
HGB flagging information.
Operational Messages and Data Flagging

Introduction Operational messages and data flags appear on the RUN MENU and on printed
reports. The CELL-DYN 1600 monitors condition and data criteria that may affect
the displayed results, and these messages and flags are used to alert the operator.
Instructions for interpreting all flags, numeric, and histogram data should be
incorporated into the laboratory's procedure and used to determine the need for
further action and/or review of results. Messages are divided into the following
categories:
Instrument Messages:
Fault Conditions
Status Conditions
Parameter Flagging Messages:

Dispersional Data Alerts
Suspect Parameter Messages
Suspect Population Flags
Instrument Fault and Status Conditions
The Instrument Fault and Status conditions are discussed 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 are displayed, refer to Chapter 10,
Troubleshooting, for assistance. Follow the instructions given and take the
appropriate corrective action. When the problem is corrected, repeat the specimen.
Parameter Flagging Messages

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

Alert messages pertaining to specimens, either patient or QC, are displayed in place
of or next to the affected result(s). All RUN, DATA LOG, and QC results for the
affected parameter(s) are displayed in inverse video and underlined on the printout.
The name of each flag, the location of the flag on the display, the cause of the flag,
and the action to be taken are given in the following explanations.
Flag: xxx (displayed in inverse video)

Cause: The parameter result is outside of operator-entered limits.
Action: Confirm background. Rerun the specimen and review a stained smear to
confirm the results.
Flag: (no display)

Cause: No result is displayed when the measurement count time is unacceptable. A
message pertaining to the probable cause displays to the right of the affected
measurement histogram. When the time for fluid to reach either detector is
too long, <CLOG> is displayed. When the time to reach either detector is
too short, <FLOW ERROR> is displayed.
Action: Press [CLEAR ORIFICE]. Rerun the specimen when the system is
ready. If <CLOG> appears again, follow the instructions in Chapter 9,
Maintenance, to clean the transducers. If <FLOW ERROR> appears
again, go to Special Protocols.
Press [MORE].
Press [PRIME REAGENT] to fill the flow system.
Or, consult Chapter 10, Troubleshooting.
Suspect Parameter Flags
These 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 the inability of the instrument 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 the action to be taken are given in the
following explanations:
Flag: LRI (Lower Region Interference)

Cause: Interference in the lower threshold region (1 - 3 fL) is greater than the
predetermined limit. This is generally non-biologic interference. The flag
may be caused by:
Debris (dirty aperture)

Contaminated reagent
Electronic noise
Microbubbles

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.
Flag: URI (Upper Region Interference)

Cause: Interference in the upper threshold region (15 - 35 fL) is greater than a
predetermined limit. This is generally biologic interference. This 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 in the upper
discriminator) in the RBC and PLT populations, review a stained smear
to determine the cause and confirm the PLT count.
Suspect Population Flags
These flags are generated when the instrument's evaluation of the measured data for
a particular parameter or group of parameters indicates the possible presence of an
abnormal subpopulation. A stained smear should be reviewed whenever a suspect
population flag is present. Therefore, instructions for interpreting flags should be
incorporated into the laboratory's review criteria for abnormal samples.
Flag: LYM R0 or RM (Displays and prints after the percent [L%] result.)
Cause: LYM data in the region to the left of 35 fL are outside the normal criteria.
Action: Check the whole blood for clots or agglutination. Redraw and rerun the
specimen as required. Review a stained smear to confirm the results.
This flag may be caused by:
Nucleated RBCs
Platelet clumps
Giant Platelets
Cryoglobulins
Incomplete lysis of red cells

Cause: LYM data in the region to the right of 35 fL are outside the normal criteria.
Lymphocytosis
Lymphopenia
Cryoglobulins
Cause: LYM data in the region to the left of 98 fL are outside the normal criteria.
Lymphocytosis
Lymphopenia
Blasts/Plasma Cells
Variant lymphocytes
Basophilia
Flag: MID R3 or RM (Displays between absolute and percent results.)

Cause: LYM data in the region to the left of 135 fL are outside normal criteria.
Action: Check the whole blood specimen for clots or agglutination. Redraw and
rerun the specimen as required. Review a stained smear to confirm
results. This flag may be caused by:
Eosinophilia
Blast/Plasma Cells
Agranular neutrophils
Platelet clumps (occasionally)
Basophilia
Bands
Flag: GRAN R3 or RM (Displays between the absolute and percent results.)

Cause: GRAN data in the region to the right of 135 fL are outside the normal
criteria.

rerun the specimen as required. Review a stained smear to confirm the
Granulocytosis
Decreased lytic action
Neutropenia
Flag: WBC R4 (Displays to the right of the total WBC result.)

Cause: Flag will be activated if the total WBC count is > 30K/)L and the mean
channel location is above 150 fL, or if the mean channel location exceeds
287 fL.
rerun the specimen as required. Review a stained smear to confirm
Monocytosis
Basophilia
Eosinophilia
Blast/Plasma cells
Increased bands
Granulocytosis
Agranular neutrophils
Variant (atypical) lymphocytes
Neutropenia
Platelet clumps (large)
Abnormal lytic action
References 1. ICSH, The Assignment of Values to Fresh Blood used for Calibrating
Automated Cell Counters, Clinical and Laboratory Hematology 1988,
10:203-212.


Chapter 4 System Specifications
System Specifications
CELL-DYN® 1600
Physical Specifications
Table 4-1 Dimensions
Dimension Analyzer Graphics Printer

Height 18" (46 cm) 4" (10 cm)
Width 33" (84 cm) 17" (43 cm)
Depth 20" (51 cm) 14" (35 cm)
23" (58 cm) CS model
Weight 145 lbs (66 Kg) 17 lbs (7.5 kg)
Table 4-2 Dimensions After Packaging for Shipment
Dimension Analyzer Graphics Printer

Height 30" (76 cm) 9" (23 cm)
Width 42" (107 cm) 22" (56 cm)
Depth 32" (81 cm) 20" (51 cm)
Weight 200 lbs (91 kg) 35 lbs (16 kg)
Data Module
Data Display 14-inch (diagonal) monochrome video display screen with amber illumination. It
provides alphanumeric display of all data, screen labels, system and specimen alerts.
Membrane Keypad The membrane keypad consists of pressure sensitive keys, each with an audible beep
indicator.
A numeric and special function keypad is located directly below the row of eight
unlabeled keys. Each key generates an audible tone when pressed. This membrane
keypad contains the following numeric and special function keys:
Numeric Keys — a block of ten numeric keys, labeled from 0 to 9, which are
used to enter numeric data
ENTER Key — stores entered numeric data and advances the cursor to the
next entry location

System Specifications Chapter 4
Asterisk (*) Key — allows the operator to escape (abort) data entry before it
is completed
Arrow Keys — a set of four keys used to move the cursor in the direction
depicted by each arrow
Pound (#) Key — used for service functions only
Graphic Printer An external dot matrix printer provides alphanumeric and graphic reports for
displayed and stored data.
Power Specifications
Table 4-3 Power Specifications
Analyzer Input Requirements
Range Frequency
90 - 125 VAC 50/60 Hz
195 - 259 VAC 50 Hz
Printer Input Requirements (Ticket or Graphics)
Setting Frequency
120 VAC 50/60 Hz
Power Consumption
Analyzer: 1000 Watts Maximum (3200 BTU per hour)
Operational Specifications
Operating Environment
Temperature: 150C to 300C (590F to 860F)

Relative Humidity: 10% to 85%, RHNC
Complete Cycle Times (READY to READY)
Auto-Startup: 120 +/- 20 seconds

Run: 60 +/- 15 seconds
Extended Run: 75 +/- 15 seconds
Auto-Calibration: 150 +/- 15 seconds
Auto-Shutdown: 120 +/- 20 seconds

Aspiration Volumes (whole blood)
Open Mode: 30 L
Pre-Dilute Mode: 40 L
Measurement Specifications
Measurement Channels
Two impedance channels, one for WBC impedance count and one for RBC and PLT.
WBC and Differential
Method: Impedance with volumetric metering

Aperture Size: 100 m in diameter x 60 m in length
Dilution: One part whole blood in 250 parts diluent plus
1.0 ± 0.25 mL lyse reagent.
RBCs and PLTs

Method: Impedance with volumetric metering
Aperture Size: 60 m in diameter x 70 m in length
Dilution: One part whole blood in 12,800 parts of diluent.
HGB
Method: Modified cyanmethemoglobin with autoblank

Light Source: LED
Wavelength: 540 nm
Dilution: One part whole blood in 250 parts diluent plus 1.0 ± 0.25
mL lyse reagent.
Performance Specifications
Linearity Linearity specifications were determined by analyzing dilutions of commercially available control
material or patient samples that contain no interfering substances and display no suspect flags.
Specifications were determined by taking multiple measurements on each dilution to minimize the
effect of imprecision. The stated limits (see Table 4-4) were determined by regression analysis
through the origin (0,0).

Table 4-4 Linearity Specifications
Parameter Linear Range Allowable Limit +/-

WBC* 1.0 - 99.9 K/L +/- 0.4 or 3.0%
RBC 1.00 - 7.00 M/L +/- 0.1 or 2.5%
HGB 2.5 - 24.0 g/dL +/- 0.3 or 2.0%
MCV 50 - 200 fL +/- 3.0 or 3.0%
HCT 10.0 - 70.0% +/- 1.0 or 2.5%
PLT 10 - 999 K/L +/- 12 or 4.0%
*Linearity specification determined by use of commercially available control material.
Accuracy The CELL-DYN 1600 system can be calibrated to agree with reference values within the allowable
calibration ranges. Both modes of operation, open and closed, may be calibrated. Thus, it is possible
to compensate for differences between modes due to differing aspiration pathways or operational
sequences. When each mode is properly calibrated according to directions given in this manual, bias
between the modes is clinically insignificant.
Greater than 0.98 correlation was obtained to reference methods and/or comparison analyzer values
for WBC, RBC, HGB, PLT, MCV, and HCT. Greater than 0.92 correlation was obtained to
comparison analyzer values for RDW, MPV, LYM and GRAN. Greater than 0.60 correlation was
obtained to comparison analyzer values for MID. Correlation data were not run for PDW and PCT.
Accuracy is verified by correlation to reference values obtained from comparison analyzers or by

reference methodology. Samples that are used for correlation studies should not display any suspect
flags.
Precision "Within Sample" precision checks routine instrument operation. It is determined as the coefficient of
variation (CV) for results obtained by running the same specimen consecutively 20 to 30 times.
Typical and absolute "Within Sample" precision data for the CELL-DYN 1600 are shown in Table 4-
5.
"Within Day" precision checks short term calibration stability. It is based on the coefficient of
variation for results obtained by running the same specimen randomly 20 to 30 times during a 24
hour period. Typical "Within Day" precision data for the CELL-DYN 1600 are provided in
Table 4-5.

"Day to Day" precision checks long term calibration stability. It is based on the
coefficient of variation for results obtained by running the same lot of commercial
control 20 to 30 times during a 10 day or longer period. Typical "Day to Day"
precision data are provided in Table 4-5.
NOTE Any system component change (e.g. recalibration, reagent brand or lot, etc.) during
this period can affect the results.
Table 4-5 Precision at 250C
Parameter Typical1 Typical2 Typical3 Absolute4

within Sample within Day Day to Day within Sample
WBC (K/L) 4.6 - 10.2 4.6 - 10.2 4.6 - 10.2 4.6 - 10.2
CV 2.3% 2.7% 3.2% 2.5%
LYM (K/L) 0.6 - 4.1 0.6 - 4.1 0.6 - 4.1 0.6 - 4.1
CV 8.0% 8.5% 9.0% 8.0%
GRAN (K/L) 2.0 - 7.8 2.0 - 7.8 2.0 - 7.8 2.0 - 7.8
CV 7.0% 7.5% 8.0% 7.0%
RBC (M/L) 4.04 - 6.13 4.04 - 6.13 4.04 - 6.13 4.04 - 6.13
CV 1.2% 1.5% 2.0% 1.7%
HGB (g/dL) 12.2 - 18.1 12.2 - 18.1 12.2 - 18.1 12.2 - 18.1
CV 1.0% 1.2% 1.5% 1.2%
HCT (vol %) 37.7 - 53.7 37.7 - 53.7 37.7 - 53.7 37.7 - 53.7
CV 1.5% 1.7% 2.0% 1.7%
MCV (fL) 80 - 100 80 - 100 80 - 100 80 - 100
CV 1.0% 1.2% 1.7% 1.5%
RDW (%) 10.6 - 14.8 10.6 - 14.8 10.6 - 14.8 10.6 - 14.8
CV 3.0% 3.5% 4.0% 3.5%
PLT (K/L) 142 - 424 142 - 424 142 - 424 142 - 424
CV 5.5% 6.0% 7.5% 6.0%
MPV (fL) 7.5 - 12.5 7.5 - 12.5 7.5 - 12.5 7.5 - 12.5
CV 6.0% 6.5% 7.5% 6.0%
1 Within Sample Protocol: 1 specimen run consecutively 20 times

2 Within Day Protocol: 1 specimen run randomly 20 times within a 24-hour period
3 Day to Day Protocol: 1 specimen run 20 times 10 consecutive days
4 Expected performance at a 95% confidence limit


Chapter 5 Operating Instructions
Operating Instructions
Introduction This chapter discusses the operation of the CELL-DYN® 1600. It is divided into 7
sections:
! Routine Operation
! Setup System Operation
! Specimen Collection and Handling
! Sample Analysis
! Daily Shutdown
! Power Off Procedure
! Using the Data Log
The chapter also includes an overview of the Data Module program. The major menus
in the program that are used for routine operation — Run and the Data Log — are
discussed in this chapter. The remaining parts of the program are discussed in the
following chapters:
Setup Chapter 2
Calibration Chapter 6
Quality Control Chapter 7
Special Protocols Chapter 9
Diagnostics Chapter 10
Data Module Program Overview
The Data Module menus are presented as key labels displayed across the bottom of the
screen. Each menu is accessed by pressing the key located directly below the label.
When the data module is powered ON, the MAIN MENU is displayed. The key labels
displayed across the bottom of this screen are used to access all of the sub-menus that
are available. The MAIN MENU keys are listed below:
[SETUP]
[RUN]
[DATA LOG]
[QC]
[CALIBRATION]
[DIAGNOSTICS]
[HELP]
[SPECIAL PROTOCOLS]

9140214 Rev DCJune 1993
Operating Instructions Chapter 5
Main Menu Screen The MAIN MENU screen is divided into 4 sections.
! The upper left corner shows the current version of the instrument software.
! The Status Box is displayed in the top center of the screen in inverse video.
This box appears on every screen to show the following:
- Menu in use
- Analyzer status
- Other applicable information, such as report or file identity, and any
existing fault conditions
! The upper right corner shows the current date, time, operator ID, and the
sequence number. The information in the upper right corner is displayed on
every screen during operation.
The cursor is positioned at the <OPERATOR ID> field when the MAIN MENU is
displayed. An operator ID of up to 3 digits may be entered. This operator ID will be
displayed on all other screens and printed on all reports.
Routine Operation
The [RUN] key on the MAIN MENU is used to display the RUN MENU.
The upper left corner of the RUN MENU screen displays the following fields:
1. <SPECIMEN ID#> used to enter the ID number for the next

sample to be run. (Up to 9 characters may be
entered.) Refer to the Sample Analysis section
for more information about this feature.
2. <TYPE:> used to display the specimen type selected.
3. <PRE-DILUTE> <PRE-DILUTE MODE> is displayed in inverse

video when the <PRE-DILUTE> field is selected.

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The Status Box is displayed in the top center of the RUN MENU screen. It contains
the following information:
! Menu in use
! Status of the analyzer
– Ready
– Not Ready
– Standby
– Initialized
! Fault messages
! Instructive messages (during the run cycle) such as the following:
– Aspirating
– Dispensing
– Remove specimen
– Counting
– Recount
– Rinsing
The upper right corner of the RUN MENU screen displays the following information:
! Current date and time

! Operator ID - Identification of the current operator
! Sequence # - Automatically incremented as samples are run
Key Labels The key labels displayed across the bottom of the RUN MENU screen are used to
access the menu options that are available. The RUN MENU keys are listed below:
[CLEAR ORIFICE]
[PRE-DILUTE]
[SPECIMEN TYPE]
[PARAMETER SELECT]
[PRINT TICKET]
[PRINT]
[HELP]
[MAIN]
Clear Orifice [CLEAR ORIFICE] is used to initiate the aperture cleaning sequence that flushes the
WBC and RBC/PLT apertures to remove obstructions. The sequence takes
approximately 35 seconds. When [CLEAR ORIFICE] is pressed, the message
<CLEARING ORIFICE> is displayed in the Status Box.

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Pre-Dilute [PRE-DILUTE] turns the pre-dilute mode run cycle ON and OFF. When ON, the
<PRE-DILUTE> message appears in the upper right section of the screen. The
specimen probe is raised and placed over the RBC/PLT dilution bath. This allows the
operator to remove the upper front cover and pour a pre-diluted 1:251 sample into the
initial dilution bath. The touch plate is then pressed to start the pre-dilute run cycle.
Specimen Type [SPECIMEN TYPE] is used to select the type of specimen that will be run. When
[SPECIMEN TYPE] is pressed, the following keys are available:
[PATIENT SPECIMEN]
[LOW CONTROL]
[NORMAL CONTROL]
[HIGH CONTROL]
[NORMAL BACKGRND]
[ELECTRICL BACKGRND]
[HELP]
[RUN]
Patient Specimen
[PATIENT SPECIMEN] is used to select the RUN MENU for running patient
samples. Patient identification may be entered on the RUN MENU after this key is
pressed. Results from this run option are stored in the Data Log.
QC Control(s)
The 3 QC control keys, [LOW CONTROL], [NORMAL CONTROL], and [HIGH

CONTROL], are used to select one of the 3 control types. Data from these control
runs are automatically stored in the designated QC file.
Normal Backgrnd
[NORMAL BACKGRND] is used to select a special run mode and to display the
background results. Results from this run option are identified by the designation
BACKGRD in the data log and are automatically excluded from the X-B analysis.

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Electricl Backgrnd
[ELECTRICL BACKGRND] is used to select the run mode for electrical background
counts. 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 BKGD in the data log and are
automatically excluded from the X-B analysis.
Help
[HELP] displays one or more screens of information that provide a brief explanation
of the screen functions and keys. When additional information is available, the
message <MORE> is displayed in the lower right corner. Press the Right Arrow key
to access this information.
Run
Press [RUN] to return to the RUN MENU screen.
Parameter Select [PARAMETER SELECT] allows the operator to choose the parameters to be
displayed and printed.
Print Ticket [PRINT TICKET] is used to print the current screen data on a ticket. It is used when
the automatic ticket print feature is set to OFF. When there is no ticket in the printer,
the message <TICKET> appears above the key labels.
Print [PRINT] is selected to print the current screen data on the graphics printer. It is used
when the automatic graphic print feature is set to OFF. When there is no paper in the
printer, the message <PRINTER> appears above the key labels.
Help [HELP] displays one or more screens of information that provide a brief explanation
of the screen functions and keys. When additional information is available, the
message <MORE> is displayed in the lower right corner. Press the Right Arrow key
to access this information.
Main Press [MAIN] to return to the MAIN MENU.

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Setup System Operation

The SETUP MENU is used to review and change options for data format to output
devices such as printers and computers. The units of measure display and print format
options are also selected from this screen.
ON The function is active.

OFF The function is not active.
Any number displayed in place of ON or OFF can be changed using the numeric keys
on the keypad to enter a new number within the stated limits. For example, the number
preceding the "line-feeds per printer page" statement applies to the graphic printer and
indicates the current line-feed selection.
To Review or Change Setup Status
1. At the MAIN MENU, press [SETUP]. The SETUP MENU displays.
Review and/or change any selection on the SETUP MENU screen.
2. ARE THE SELECTIONS ACCEPTABLE?
YES Press [MAIN] to return to the MAIN MENU screen.
NO Use the Arrow keys on the keypad to move the cursor to the
selection requiring change.
Press Enter to toggle between ON or OFF.
OR
Type the new number that is within the limits shown for the
selection. Repeat this process until all required changes are
complete. Go to the Date/Time Setup procedure.
The SETUP MENU is also used to enter or review numeric data, such as date, time,
patient specimen limits for alert, control lot number, target and limits values for
control, replicate and X-B program files, etc. Refer to Chapter 2, Installation, for
procedures.

9140214 Rev DCJune 1993
Specimen Collection and Handling

Specimen Stability Fresh whole blood specimens are recommended. The ICSH defines a fresh blood
specimen as one processed within 4 hours after collection.
Well-mixed whole blood specimens, collected in EDTA anticoagulant and run within 8
hours after collection, provide the most accurate results for all parameters. The white
cells size distribution may shift when specimens are assayed between 5 and 20 minutes
after collection or more than 8 hours after collection.
The stability of capillary specimens collected in micro-collection devices may vary

depending on the micro-collection device manufacturer. Refer to the manufacturer's
package insert for stability claims.
Specimen Collection All samples should be collected using proper technique.
NOTE For additional information on collecting venous and capillary samples, refer to NCCLS
Standards, H3-A31 and H4-A32.
Sample Analysis An overview of sample analysis on the CELL-DYN 1600 is provided in Chapter 3,
Principles of Operation. This section provides guidelines and instructions for the routine
sample analysis.
• Samples should not be run until the instrument has been initialized and daily QC
checks have been performed.
• Samples may be analyzed whenever READY is displayed in the Status Box on
the RUN MENU.
• Samples should be well mixed before they are run.
CAUTION If the System has been idle for 15 minutes or more, a normal background should be
run immediately prior to running any patient specimens.
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 ticket report. It is also
retained in the QC logs and the Data Log.
The Operator ID is entered from the MAIN MENU. When this screen is selected, the
cursor is positioned in the <OPERATOR ID> entry field. Type up to 3 digits and press
[ENTER] to save the ID number.

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Sample Identification Sample identification information is entered in the upper left corner of the RUN MENU.
These entry fields are made available by pressing [SPECIMEN TYPE]followed by
[PATIENT SPECIMEN .]
1. A sample ID number of up to 9 digits may be entered in the

<NEXT ID> entry field.
2. An auto-increment feature automatically increases the sample ID number by 1

digit each time a sample is run.
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. Refer to Chapter 3, Principles of Operation, for detailed explanations
of each flag.
• Results that fall outside the range of the limit set are displayed in inverse video.
These results are underlined on the graphic printout. They are indicated by an
asterisk on a pre-printed ticket.
• Results that exceed a parameter's linear range are indicated by >>>> in place of
the result.
• If a WBC 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 and count times are also displayed.
These messages and times are also printed in the graphics report.
NOTE A complete explanation of metering faults is given in the Operational Messages and
Data/Parameter Flagging sections of Chapter 3, Principles of Operation.
• [CLEAR FAULT ]is displayed and a message (e.g.,<DILUENT EMPTY >)

appears in the Status Box on the data module if a fault condition is detected. The
Status Box displays the message<FAULT: SEE DIAG>or <SEE SPECIAL>
to direct the operator to either the DIAGNOSTICS or the SPECIAL
PROTOCOLS menu for further instructions.
NOTE After the problem has been corrected, press [CLEAR FAULT ] to resume operation.

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Instrument Start Up The CELL-DYN 1600 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 4 hours, an automatic shutdown cycle is initiated. The instrument is placed in the
STANDBY mode at the end of the automatic shutdown cycle.
Power to the printer may be left ON or OFF at the operator's discretion. Refer to
Chapter 11, Printers, for complete instructions for printer operation.
A complete procedure for powering the system ON or OFF is given in Chapter 2,

Installation.
Daily Start Up Procedures
The automatic Start Up cycle is designed to prime the flow system and check the
background counts whenever STANDBY or INITIALIZED appear in the Status Box on
the RUN MENU screen. Auto-startup is activated by pressing [RUN] on the MAIN
MENU.
Startup Procedure 1. Be sure that READY is displayed in the Status Box.
CAUTION If the System has been idle for 15 minutes or more, a normal background should be run
immediately prior to running any patient specimens.
2. If the Status Box on the RUN MENU screen displays STANDBY or

INITIALIZED, press [RUN] to initiate the automatic start up cycle.
3. Perform the daily Quality Control checks asdirected in the following section.
Daily Quality Control Checks
Quality Control checks should be performed on a daily basis according to the

laboratory's protocol. Commercial control materials should be properly warmed and
mixed according to the manufacturer's recommendations. Patient controls should be
handled according to the laboratory's protocol.
1. From the RUN MENU screen, press [SPECIMEN TYPE].
2. Select the key label for the type of specimen to be run:[PATIENT

SPECIMEN], [LOW CONTROL ,] [NORMAL CONTROL ,] [HIGH
CONTROL ], or one of the nine replicate files. The type currently selected is
displayed in the upper left section of the screen.
3. Run the control following the “Running Samples” procedure presented on the
next page.

9140214 Rev F—April 1996
4. Verify that the results are acceptable.
NOTE Out of range control results are displayed in inverse video.
5. 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. See Chapter 10, Troubleshooting.
6. When the control results are acceptable, patient samples can be analyzed.
Running Samples 1. Be sure that READY is displayed in the Status Box on the RUN MENU screen.
2. Open the sample tube. Place it under the sample aspiration probe so that the
probe is immersed in the well-mixed sample. Consider all clinical specimens as
potentially infectious. Use established, good laboratory working practice when
handling these samples.
3. Press the touch plate located behind the probe to start the cycle. The Status Box
on the RUN MENU displays messages to indicate the various stages of the
cycle.
4. Remove the sample tube after the beepsounds. The probe moves up through the
wash block for cleaning.
5. When the cycle is complete, the probe moves down into position for the next
sample and the results are displayed on the screen.
6. If automatic report printing has been specified, a report is printed according to

the parameters selected during Setup.
7. Repeat this procedure for subsequent samples.
Daily Shutdown It is not necessary to perform a shutdown procedure daily as the instrument
automatically goes into the STANDBY mode if it has been idle for 4 hours. If desired,
the operator may place the instrument in the STANDBY mode by pressing [DAILY
SHUTDOWN] on the second SPECIAL PROTOCOLS MENU screen. This causes
the equipment to:
1. Rinse the flow system.
2. Set the timer control that periodically opens all of the solenoid valves to prevent
pinched tubing.

9140214 Rev F—April 1996
Power Off Procedure

Whenever power to the instrument is to be turned OFF, the operator must perform the
same procedures described above in the automatic shutdown cycle.
1. Press [DAILY SHUTDOWN] on the second SPECIAL PROTOCOLS

MENU screen.
2. When the cycle is complete, move the side panel power switch to OFF.
3. Remove the tubing from the lyse pump rotor to prevent pinching.
4. Follow the procedures described in Chapter 2, Installation, when the power is

restored.
Using the Data Log

The Data Log stores all data in a log format for the last 320 cycles run on the
instrument. The information is stored chronologically by sequence number.
Data Log Menu When [DATA LOG] is pressed, the DATA LOG screen is displayed and the following
keys are available:
[FIND SEQ OR SPECIMEN ID]

[EDIT SPECIMEN ID]
[REJECT/ACCEPT SPECIMEN]
[PRINT REPORT FOR 1 SPECIMEN]
[TRANSMIT DATA]
[PRINT DATA SUMMARY]
[HELP]
[MAIN]
Find Seq or Specimen ID
[FIND SEQ OR SPECIMEN ID] is used to find a specific sequence ID # or

specimen ID # among those displayed on the DATA LOG screen.
When [DATA LOG] is pressed, up to 16 of the latest specimen results are displayed
on the DATA LOG screen. To display a specific sequence ID #, press [FIND SEQ
ID]. The cursor moves to the <SEQUENCE #> field. Type the desired number and
press [ENTER].

9140214 Rev DCJune 1993
Edit Specimen ID [EDIT SPECIMEN ID] is used to edit the Specimen ID # from the DATA LOG
screen. When [EDIT ID] is pressed, the cursor moves to the <SPECIMEN ID> field
and all key labels are blank. Edits are saved by pressing [ENTER].
Reject/Accept Specimen
If the cursor is positioned at a sample identified with a B preceding the sequence

number, the sample results are included (accepted) in the X-B analysis.
! To reject the sample results, press [REJECT/ACCEPT SPECIMEN].

The B is deleted and an R is displayed following the specimen ID.
! To accept the sample results, press [REJECT/ACCEPT SPECIMEN].
The R is deleted and a B is displayed preceding the specimen ID.
Print Report for 1 Specimen
[PRINT REPORT FOR 1 SPECIMEN] is used to print the results of the selected
specimen indicated by the position of the cursor in patient report format or ticket
format.
NOTE No histogram data is stored or printed.
When [PRINT REPORT FOR 1 SPECIMEN] is pressed, the following keys are
available:
[GRAPHICS PRINTER]
[TICKET PRINTER]
[HELP]
[RETURN]
Transmit Data [TRANSMIT DATA] is used to transmit a record to an on-line computer. When
[TRANSMIT DATA] is pressed, the screen prompts 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 numbers.
NOTE No histogram data is stored or printed.
Print Data Summary [PRINT DATA SUMMARY] performs the same task as [TRANSMIT DATA], only
the data is printed on the graphics printer rather than transferred to an on-line
computer.

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References 1. NCCLS Standard H3-A3, Procedure for the Collection of Diagnostic Blood
Specimens by Venipuncture—Third Edition; Approved Standard (1991).
2. NCCLS Standard H4-A3, Procedure for the Collection of Diagnostic Blood

Specimens by Skin Puncture—Third Edition; Approved Standard (1991).

9140214 Rev DCJune 1993

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Chapter 6 Calibration
Calibration
Introduction The CELL-DYN® 1600 is calibrated at the factory just before shipment. An Abbott
authorized Field Service Representative assists the operator in confirming the
calibration during instrument installation. Calibration may be performed with
commercial calibrator or fresh whole blood samples. Only the directly measured
parameters WBC, RBC, HGB, MCV, PLT, and MPV may be calibrated.
The instrument is electronically stable and should not require frequent recalibration
when it is operated and maintained according to the recommendations in this manual.
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 1600 in these quality control
programs. The programs include statistical computations and Westgard Rules for
commercial or patient controls and monitoring of patient samples for RBC parameters
using Bull's moving average program (X-B).
Calibration should be confirmed on a regular basis according to the requirements

governing quality control in your laboratory. In keeping with good laboratory
practices, this should include daily verification on each shift and following a reagent
lot number change. Verification of calibration is also recommended following the
replacement of any major instrument component that could affect calibration.
Calibration may be verified 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.
Calibration Guidelines
General Information The CELL-DYN 1600 has 3 modes of operation:
! Open mode
! Closed mode
! Pre-dilute mode
For convenience, the Open mode is calibrated first and the Closed mode and Pre-dilute
mode are then referenced to it. There are several ways to accomplish the total
calibration, depending only on the preference of the user. The following Calibration
Procedural Guidelines section provides a quick reference guide to the remainder of the
chapter.

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Calibration Procedural Guidelines
There are several ways to accomplish total calibration of the system. They are:
! Auto-Cal — automatic calibration program incorporated in the software

! Factor Entry Calibration — an alternative to Auto-Cal
! Lyse Volume Dispense Calibration
! Latex Particle Calibration (MPV only)
The instrument's Open mode is calibrated with the calibration material of choice, using
the method of choice. The Closed mode is then referenced to match the Open mode
with fresh whole blood samples (refer to the Addendum section of this manual for
instructions). This chapter contains an overview of the calibration methods and gives a
detailed explanation of how to perform each procedure. Review the Pre-Calibration
Guidelines section before beginning the selected calibration procedure.
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.
For manual calibration, worksheets may be used to assist in making the necessary
calculations. These worksheets may be duplicated as needed.
Calibration Materials
CAUTION Consider all clinical specimens and controls, calibrators, etc. that contain human blood
or serum as potentially infectious. Use established, good laboratory working practices
when handling these samples. Wear gloves, lab coats and safety glasses and follow
other biosafety practices as specified in the OSHA Bloodborne Pathogen Rule or other
equivalent biosafety procedures.
3 calibration materials can be used to calibrate the CELL-DYN 1600:
! CELL-DYN calibrator
A calibrator is the preferred material for calibrating the CELL-DYN 1600. It
is most efficiently performed by calibrating the Open mode using the Auto-Cal
method. The Closed mode is then referenced to match the Open mode using
fresh whole blood samples.
NOTE The term “calibrator” refers to a commercial reference material—either calibrator or

control. According to the Food and Drug Administration (FDA), when a control is
used as a calibrator, a different lot or brand of control must be used for daily quality
control.
NOTE Never use a hemoglobin standard that is designed specifically for use with
cyanmethemoglobin reagents.

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! Latex Particles
Latex particles are used to calibrate the Mean Platelet Volume. This
calibration is verified by an Abbott authorized representative during
installation of the instrument.
! Fresh Whole Blood
Calibration with fresh whole blood is accomplished by performing multiple
analyses of each sample by acceptable reference methodology and calculating
the mean reference value for each parameter. The same samples are analyzed
on the CELL-DYN 1600 in the Open mode. The Closed mode is then
referenced to match the Open mode using another set of fresh whole blood
samples. A detailed discussion of Whole Blood Calibration is given in the next
section.
Whole Blood Calibration Guidelines

Introduction Calibration with fresh whole blood samples is an alternative to calibration with a
commercial calibrator. This section explains the determination of reference values and
gives requirements for whole blood samples.
Sample Requirements for Fresh Whole Blood
The following requirements should be observed for fresh whole blood samples used for
calibration:
! The ICSH recommends that fresh samples be less than 4 hours old. Sample age
must not exceed 8 hours at the conclusion of the calibration procedure.
! All parameter values should be within the laboratory's normal range. The
following ranges are programmed for the reference values that may be entered
in the Auto-Cal program. Results exceeding these limits cannot be entered.
WBC 5.0 — 12.0

RBC 3.50 — 5.50
HGB 10.0 — 24.0
MCV 80 — 100
HCT 30.0 — 50.0
PLT 150 — 400

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NOTE Obtain a reference RBC and HCT value for each calibration specimen. When the RBC
and HCT values are entered, a reference MCV is automatically calculated.
! All cellular morphology must be normal.

! No known interfering substances should be present (e.g., lipemia, icterus,
drugs).
! All samples must be properly collected in the EDTA anticoagulant used by the
laboratory.
! Each tube should contain at least 90% of the nominal collection volume of
blood.
Determination of the Reference Values
Reference values for Whole Blood Calibration should be determined according to the
following ICSH recommendations.
WBC, RBC, and PLT
Reference values may be determined using multiple counts from a certified

hemocytometer or from a reliably calibrated hematology analyzer.
Hemoglobin Reference values 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 1600 with a hemoglobin standard
designed for the calibration of specific reference cyanmethemoglobin methods. The
instrument uses a modified hemiglobincyanide method which is not designed to analyze
these standards directly.
MCV Reference values 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
NCCLS method for Packed Cell Volume (PCV). Use only plain (non-anticoagulated)
capillary tubes. Be certain to verify the proper operation of the microhematocrit
centrifuge and the timer as recommended by NCCLS.

9140214 Rev DCJune 1993
Calibration Requirements for Fresh Whole Blood
Minimum requirements for Whole Blood Calibration are described in the following
list. Additional samples and/or more replications of the samples may be used.
! A minimum of 5 samples is required for adequate Whole Blood Calibration.

! Samples must be assayed at least in triplicate by reference methodology and on
the CELL-DYN 1600.
! No more than 2 hours should elapse between the CELL-DYN 1600 run and the
assay by reference methodology. If samples are run on the
CELL-DYN 1600 first, assay by reference methodology should be completed
within 1 hour. (Certain reference methodologies are sensitive to RBC swelling
caused by in vitro deoxygenation.)
! 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.
! If Auto-Cal is not being used, the mean parameter values should be averaged
to obtain the cumulative mean value for each parameter.
NOTE A worksheet is provided on the following page. This worksheet may be used to assist
with the calculation of the reference means and may be duplicated as needed.

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Whole Blood Calibration Reference Values Worksheet

Date:__________________________________ Parameter: _____________________________
Technologists: __________________________ Method: _______________________________
Sample Reference Assays Mean

ID
1 2 3 4 5 6 7 8 9 10
Cumulative Parameter Mean

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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 must be completed just
before beginning calibration. If problems are detected during these checks, DO NOT
ATTEMPT TO CALIBRATE THE INSTRUMENT. If necessary, call the Customer
Support Center for assistance. After the problems have been resolved, repeat the pre-
calibration procedures to verify proper performance. Review the following guidelines
before beginning any calibration procedure.
• Use specimens that have NO known interfering substances.

• Use specimens that are at room temperature and mixed properly.
• Use only the recommended CELL-DYN reagents -- other brands are
unacceptable. (See Chapter 7, Quality Control.)
• Confirm that reagent containers are at least half full -- replace them as necessary.
• Prior to calibration, instrument precision should be verified within stated
Absolute Limits. (See Chapter 4, Table 4.5)
• 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.
• Confirm that Normal Background is within limits.
• Confirm that the operator ID number is entered.
CAUTION If the System has been idle for 15 minutes or more, a normal background should be run
immediately prior to running any calibration specimens.
Calibration Logbook
Abbott suggests that you 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 want to include in the logbook are:
• Laboratory operating procedures

• Quality Control
• Calibration
• Maintenance
• Troubleshooting
• Problem resolution
• Service calls
• Installation documentation
This logbook should be stored near the instrument and be accessible to all operators and
Abbott Service Personnel.
Calibration Menu Screen

9140214 Rev F—April 1996
The CALIBRATION MENU screen is accessed from the MAIN MENU screen by
[CALIBRATION] The CALIBRATION MENU screen is explained in this
pressing [CALIBRATION].
section.
This section will introduce the keys displayed after the Calibration mode is selected.
The function of each key that appears on the CALIBRATION MENU screen is
explained in this section.
Enter Factor [ENTER FACTOR]is used to enable the operator to enter calibration factors
directly (Factor Entry Method).
Pre-dilute [PRE-DILUTE] is used to toggle between selecting and deselecting the pre-dilute mode and to load
corresponding calibration factors for review and possible change.
Auto-Cal Select [AUTO CAL SELECT]is used to display the screen labels for the calibrator, fresh
whole blood, and latex particles calibration methods.
Calibrator [CALIBRATOR] initiates calibration using a calibrator.
Fresh Blood [FRESH BLOOD] initiates calibration using fresh blood specimens.
Latex Particles [LATEX PARTICLES] initiates calibration of MPV using latex particles.
Lyse Volume [LYSE VOLUME] selects the menu for lyse volume procedures.
Print [PRINT] is used to print a report of the current calibration factors.
Return [RETURN] returns the display to the main calibration screen.
Auto-Cal Method
Introduction This method allows the operator to enter reference assay values and run either whole
blood or calibrator with CELL-DYN 1600 reference values. The computer utilizes the
entered results from a minimum of 3 runs to calculate a factor for each specimen. A

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Auto-Cal Method
Introduction This method allows the operator to enter reference assay values and run either whole
blood or calibrator with CELL-DYN 1600 reference values. The computer utilizes the
entered results from a minimum of 3 runs to calculate a factor for each specimen. A
mean factor is calculated for all specimens run.
Procedure 1. Obtain the appropriate calibration materials, either calibrator or fresh whole
blood.
! If a calibrator is used:
— Ensure that commercial calibrator vials are brought to room
temperature and mixed according to the manufacturer's
instructions given in the package insert.
— Ensure that the calibrator's expiration date has not been reached.
! If fresh whole blood is to be used, follow the guidelines provided in this
chapter relating to the selection and use of fresh whole blood samples.
2. At the MAIN MENU screen, press [CALIBRATION].
3. Press [AUTO CAL SELECT].
4. Press the appropriate key for the calibration method you are using, either
[FRESH BLOOD] or [CALIBRATOR].
5. Set the cursor to the parameter to be calibrated.
6. Press [ENTER]. The screen changes to reflect your updates.
7. Enter the parameter's reference assay value for the calibration specimen to be
run (RBC calibration requires 3 digits). The cursor automatically advances to
the next selection.
NOTE When MCV is selected, the message <REFERENCE VALUE FOR MCV MAY BE
SUPPLIED BY ENTERING VALUES FOR RBC AND HCT. TO DO SO,
PRESS # AND ENTER VALUES WHEN PROMPTED.> appears in the lower
screen. When [#] is pressed, MCV changes to RBC, allowing the operator to enter the
red cells reference value (using 3 digits). Then <HCT> appears allowing the operator
to enter the hematocrit reference value. The computer calculated MCV reference value
must be within the normal range of 80 to 100 to be accepted and displayed.
8. Repeat steps 4 through 6 until all parameters to be calibrated with the

calibration specimen are selected and the corresponding reference values are
entered.
9. Mix the specimen well by inverting it at least 10 times. Do not shake the
specimen.

9140214 Rev DCJune 1993
10. When <READY> appears, place the well-mixed specimen under the aspirating
probe and press the Touch Plate to actuate the auto-calibration cycle. The
analyzer performs RUN 1 measurement and displays the values in the RUN 1
column.
11. When the cycle is complete, repeat step 10 twice — once for RUN 2
measurement and once for RUN 3 measurement.
NOTE When the value for any run exceeds the computer acceptance criteria, the value is
highlighted indicating the measurement cycle must be repeated. Should this situation
occur repeatedly, press [ABANDON] to stop the auto-calibration process for this
specimen without deleting the mean factor for specimens already run. If necessary,
obtain technical assistance or see Chapter 10, Troubleshooting, for corrective action.
12. When results for the 3 runs are acceptable, the calibration factor is calculated
using the accepted run data for each parameter selected in steps 4 and 7. The
screen displays the calculated factor and mean factor for each parameter
indicating the auto-calibration cycle for this specimen is complete.
13. Repeat steps 4 through 11 for each calibration specimen.
WARNING Do not press [RESET FACTORS] between specimens. This key is used to delete the
mean factor for all specimens run prior to pressing the key.
14. After all calibration factors are run, press [RETURN]. The main calibration
screen appears. The calibration factors are saved at this point.
15. Press [PRINT] to print the new calibration factors.
16. Press [MAIN] to return to the MAIN MENU screen.
17. Press [RUN] to return to the RUN screen.
18. Run one of the following:
! 3 additional specimens with reference assay values

! 3 levels of controls
19. Confirm that the results obtained for each specimen:
! agree with the reference value within 2SD

OR
! are within control limits.
NOTE If the results for any parameter are consistently out, repeat calibration or obtain
technical assistance.

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Factor Entry Method

Introduction Enter factor key calibration is used to reset calibration to the factory calibration setting
of 1.00. It can also be used to enter a pre-determined factor to adjust calibration when
a consistent bias exists between CELL-DYN 1600 and a comparison analyzer or
reference method. A percent bias factor can be determined and entered to change
calibration within ± 20% for any of the directly measured parameters — WBC, RBC,
HGB, MCV, PLT, MPV.
Procedure 1. Run in triplicate, multiple (minimum of 3) specimens via comparison analyzer

or method.
2. Calculate a cumulative reference mean (REF) for all specimens and runs for
each parameter. For example:
The reference WBC mean is 6.6 when all of the following are true:
! specimen 1 RUN 1 = 6.8, RUN 2 = 6.9, RUN 3 = 6.8
! specimen 2 RUN 1 = 9.2, RUN 2 = 9.0, RUN 3 = 9.2
! specimen 3 RUN 1 = 3.9, RUN 2 = 4.0, RUN 3 = 4.0.
3. Run in triplicate the same specimens run in step 1 via CELL-DYN 1600 with
an empty replicate file selected. Run all specimens in the same replicate file to
obtain a cumulative CELL-DYN (CD) mean for all specimens and runs.
4. Press [MAIN].
5. Press [QC] and select the appropriate replicate file.
6. Press [PRINT] to print the summary report for the selected replicate file to
obtain a cumulative CD mean for each parameter.
7. Divide the reference mean from step 2 by the CELL-DYN 1600 mean printed
in step 6 (REF divided by CD = calibration factor). For example:
! When REF is 6.6 and CD WBC is 7.2, the calibration factor is 0.92 (6.6
divided by 7.2 = 0.917)
! When REF is 6.6 and CD WBC is 5.9, the calibration factor is 1.12 (6.6
divided by 5.9 = 1.119).
8. At the MAIN MENU screen, press [CALIBRATION]. A new screen and new
labels appear.
9. Press [ENTER FACTOR]. A new screen and new labels appear.
10. Set the cursor to the parameter requiring the calibration factor change and type
the new factor using 3 digits. To reset the number to the current factory
setting, type [1] [0] [0].

9140214 Rev DCJune 1993
11. Repeat the previous step (step 10) as required to enter a new factor for each
parameter.
12. Press [RETURN] to return to the main calibration screen. As required, press
[PRINT] to print the current calibration status.
13. Press [MAIN].

! 3 level controls.
16. Verify that the results obtained for each specimen:

OR
NOTE When results for any parameter are consistently out, repeat calibration for that
parameter or obtain technical assistance.

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Pre-Dilute Method
Introduction The pre-dilute calibration mode allows the operator to calibrate the CELL-DYN 1600
to adjust for any differences due to dilution when this special mode is selected. The
pre-dilute calibration procedure and specimens are similar to the whole blood or
calibrator method given earlier in this chapter. However, for pre-dilute calibration each
calibration specimen is pre-diluted in the same manner as unknown patient specimens
using CELL-DYN micropipettes 40uL end-to-end (30mm) with EDTA and 10mL of
diluent that is dispensed using [10ml. DISPENSE] from the SPECIAL
PROTOCOLS screen.
Procedure 1. Obtain either a calibrator with CELL-DYN 1600 calibration reference values
or one or more calibration specimens that meet the guidelines for each
parameter.
2. Press [SPECIAL PROTOCOLS] to go to the SPECIAL PROTOCOLS

screen.
3. Press [MORE] twice.
4. Press [10ml. DISPENSE] to activate the dispense mode.
5. Place an unused sample vial under the sample aspiration probe and press
[10ml. PRE-DILUTE]. 10mL of diluent dispenses into the sample vial.
6. Repeat this process to obtain a minimum of three vials of diluent for each
specimen to be run for calibration.
8. Press [CALIBRATION].
9. Press [PRE-DILUTE]. Select the calibration method.
10. Set the cursor to the parameter to be calibrated.
11. Press [ENTER]. The screen changes.
12. Enter the parameter's reference assay value for the calibration specimen to be
run (e.g. <4> <8> <9> for RBC). The reference assay value always requires 3
digits. The cursor automatically advances to the next selection.

9140214 Rev DCJune 1993
NOTE When MCV is selected, the following message appears in the lower screen: <THE
REFERENCE VALUE FOR MCV MAY BE SUPPLIED BY ENTERING
VALUES FOR RBC AND HCT. TO DO SO, PRESS # AND ENTER
VALUES WHEN PROMPTED.> When [#] is pressed, MCV changes to RBC,
allowing the operator to enter the red cells reference value (using 3 digits). <HCT>
appears allowing the operator to enter the hematocrit reference value. The computer
calculated MCV reference value must be within the normal range of 80 to 100 to be
accepted and displayed.
13. Repeat steps 10 through 12 until all parameters to be calibrated with this
calibration specimen are selected and the corresponding reference values are
entered.
14. Grasp the lower edge of the Upper Front Cover and pull it towards you (out)
about 1 inch. Raise it up until it releases from the upper mount brackets. Set
the cover aside or on top of the analyzer. (See Figure 6-1.)
WARNING To prevent aspirating probe damage, always confirm the probe is raised before
attempting to remove the upper front cover.
NOTE The grounding wire may be detached to completely remove the Upper Front Cover.
Figure 6-1 Removing the Front Cover
15. Mix the calibration specimen well by inverting it at least 10 times. Do not
shake the specimen.
16. Completely fill a CELL-DYN micropipette with well-mixed calibration

specimen.

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17. Wipe the outside of the pipette with a lint-free gauze slightly dampened with
diluent to remove excess blood. DO NOT REMOVE THE BLOOD FROM
INSIDE THE PIPETTE.
18. Drop a filled pipette immediately into a vial containing 10mL of diluent. (This
vial was prepared in step 5.)
19. Close the vial at the upper crease and invert a minimum of 15 to 20 times to
thoroughly mix the blood and diluent (see figure 6-2).
Figure 6-2 Vial Closure for Mixing
NOTE The internal bore size of the CELL-DYN micropipette is designed to allow rapid
mixing of blood and diluent. This initial 1:250 dilution is stable for 20 minutes and
must be thoroughly remixed by inversion before pouring it into the initial dilution bath
when the pre-dilute mode is selected.
20. Open the vial and carefully pour the diluted specimen into the initial dilution
bath.
CAUTION Do not allow the micropipette to fall into the dilution bath.
21. Press the touch plate to actuate the pre-dilute auto-calibration cycle. This
performs the RUN 1 measurement and displays value(s) in the RUN 1
column.
22. When the cycle is complete, repeat steps 15 through 21 twice — once for RUN
2 measurement and once for RUN 3 measurement.
NOTE When the value for any run exceeds the computer acceptance criteria, the value is
occur repeatedly, press [ABANDON] to stop the auto-calibration process for this
specimen without deleting the mean factor for specimens already run. See Chapter 10,
Troubleshooting, or obtain technical assistance.
23. When results for 3 runs are acceptable, the calibration factor for each
parameter selected in steps 10 and 12 is calculated using accepted run data.
The screen displays the factor and mean factor for each parameter indicating
the auto-calibration cycle for this specimen is complete.

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NOTE Do not press [RESET FACTORS] between specimens. This key is used to delete the
mean factor for all specimens run prior to pressing the key.
24. Repeat steps 12 through 22 for each calibration specimen.
25. When all calibration specimens are run, press [RETURN]. The calibration
factors are now saved. The main calibration screen appears.
27. Press [MAIN].
29. Press [PRE-DILUTE] to select the pre-dilute mode.

! 3 levels of controls via the pre-dilute method.

OR
NOTE If results for any parameter are consistently out, repeat the calibration or obtain
Latex Particles Method

Introduction Calibration is required when mean platelet volume (MPV) values for QC specimens
indicate that MPV is out-of-calibration. This procedure enables the operator to
calibrate MPV utilizing latex particles. To date there is no acceptable reference
method established for determination of a reference MPV. MPV calibration requires
latex particles, and must be calibrated using this method.
Guidelines for Calibration
Review the following guidelines before beginning this calibration procedure.
! Use only the required latex particle and reagents. Other brands are
unacceptable.
! Resuspend latex particles according to the directions provided in the package
insert.

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Procedure 1. Obtain latex particles and mix them according to the directions provided in the
package insert to completely resuspend them.
NOTE Aggregates will cause invalid calibration for MPV.
2. At the MAIN MENU screen, press [CALIBRATION].
3. Press [LATEX PARTICLES]. A new screen appears.
4. Set the cursor to MPV and press [ENTER]. The screen changes.
5. Enter the reference assay value for latex particles to be run (using 3 digits).
6. Mix the calibration specimen well by inverting it at least 10 times. Do not

shake the specimen.
7. When <READY> appears, place the well-mixed calibration specimen under

the aspiration probe. Press the Touch Plate to actuate the auto-calibration
cycle. This performs the RUN 1 measurement and displays values in the RUN
1 column.
8. When the cycle is complete, repeat step 7 twice — once for RUN 2
measurement and once for RUN 3 measurement.
NOTE When the result for any run exceeds the computer acceptance criteria, the result is
occur repeatedly, consult Chapter 10, Troubleshooting, or obtain technical assistance.
9. When results for 3 runs are acceptable, the calibration factor is calculated
using the accepted run data. The calculated factor and mean factor display
indicating the auto-calibration cycle is complete.
10. Press [RETURN]. The main calibration screen appears.
12. Press [MAIN] to return to the MAIN MENU.

! 3 levels of controls.

9140214 Rev DCJune 1993

OR
NOTE If results for any parameter are consistently out, repeat calibration or obtain technical
assistance.
Lyse Volume Dispense Calibration

The volume of lyse dispensed is factory set. The amount of lytic reagent dispensed
affects the diff-screen results and can vary slightly as a result of tubing and rotor wear
during routine use. When lytic action is too little (increased alerts and size data shifted
to the right), the amount of lyse dispensed can be increased. When lytic action is too
great (increased alerts and size data shifted to the left), the amount of lyse dispensed
can be decreased.
Verification of the volume of lyse dispensed per cycle is required when the lyse tube
under the pump rotor is replaced. It should be reset as needed to maintain diff-screen
result accuracy. For special applications or research, the amount of lytic reagent
dispensed is adjustable within the allowable range of 0.75 or 1.25mL.
NOTE The volume of lyse dispensed is set by the factory at approximately 1.1 mL.
Verification of lyse volume dispensed is done using a new screen and labels that
appear when [LYSE VOLUME] is pressed. A 25mL graduated cylinder is required
for this procedure.
Procedure 1. At the MAIN MENU screen, press [SPECIAL PROTOCOLS].
2. Press [MORE] until [10ml. DISPENSE] appears.
3. Place a 25mL graduated cylinder under the aspiration probe and press [10ml.
DISPENSE] twice to actuate the dispense.
4. Repeat step 3 to dispense an additional 10mL of diluent. Determine in

milliliters the exact amount of diluent in the cylinder.
5. Press [MAIN].
7. Press [LYSE VOLUME]. A new screen appears.

9140214 Rev DCJune 1993
8. Remove the lyse inlet tubing from the lyse container and place it into the 25mL
graduated cylinder. Make sure the end of the tubing touches the bottom of the
cylinder.
9. Press [MEASURE VOLUME] to activate 10 consecutive lyse dispense

cycles. This is a default cycle and disregards any entered volume.
10. When the lyse pump action stops, remove the lyse inlet tubing and measure the
amount of the diluent aspirated. For an accurate measurement, the lyse tubing
must be removed.
NOTE Default dispense volume: The measured volume of diluent in milliliters from step 3
minus the measured volume of diluent remaining in the cylinder equals the volume of
lyse dispensed during 10 cycles.
11. Enter the default dispense volume in milliliters using the keyboard numeric
keys (9.0 to 11.0).
12. Press [SET VOLUME]. The current set volume appears with the set volume
statement.
13. Type the new volume for lyse dispense in milliliters using the keyboard
numeric keys (0.75mL to 1.25mL).
NOTE The new volume is the number obtained in step 10 divided by 10.
14. Press [ENTER].
NOTE When no entry is made, no screen labels appear. Press [ENTER] to continue.
15. Repeat steps 1 through 3 to add additional diluent to the cylinder.
16. Place the end of the lyse tubing into a 25mL graduated cylinder. Confirm the
end of the tubing touches the bottom of the cylinder.
19. Press [LYSE VOLUME].
20. Press [VERIFY VOLUME].
When the lyse pump action stops, remove the lyse inlet tubing and measure the amount
of diluent aspirated. This number should equal the new volume entered in step 13
multiplied by 10 ± 0.2mL.
NOTE If the two volumes do not agree, repeat this entire procedure or obtain technical

9140214 Rev DCJune 1993
assistance.
21. Remove the lyse inlet tubing from the cylinder.
22. Press [VERIFY VOLUME]. Air circulates through the tube.
23. Place the lyse inlet tubing in the container of lyse.
24. Press [VERIFY VOLUME] again to refill the lyse inlet tubing with lyse
reagent.
25. Press [MAIN]. The MAIN MENU screen appears.
26. Press [RUN]. The RUN screen appears.
! 3 to 5 specimens with WBC and/or HGB reference assay values

! 3 levels of controls.
28. Verify that the results obtained for each specimen:
! agree with reference value with 2SD

OR
NOTE When results for either parameter are consistently out, repeat calibration for that
parameter or obtain technical assistance.

9140214 Rev DCJune 1993
Chapter 7 Quality Control
Quality Control
Introduction The CELL-DYN® 1600 offers several Quality Control (QC) options to monitor and
validate instrument performance. The options are:
Commercial Controls — Numeric data obtained for each parameter are

automatically transmitted to a designated file (low control, normal control, or high
control) when that control file is selected.
Replicate Specimen — This option works the same as the Commercial Controls
program. The Replicate Specimen QC Program is non-specific for specimen type.
Therefore, it can be used for previously run specimens, additional (overlapping)
commercial control material, precision specimens, etc.
X-B Analysis — This QC option is useful for troubleshooting and confirming the
calibration of the red cells parameters.
Quality Control Log

This section discusses the options available when [QC] is pressed at the MAIN
MENU. The options used to set up the QC files are available by pressing [SET UP]
at the MAIN MENU. Refer to the Keypad Setups section of Chapter 2, Installation,
for details regarding setting up the Control Files, Replicate Files, and X-B Files.
The QC LOG screen allows the operator to perform the following functions:
C Select 1 of 12 QC files
C Review, edit, or print stored data for each file including
— lot number and expiration date or identification number
— acceptable upper and lower range
— results for all parameters up to 30 runs
— mean
— standard deviation
— coefficient of variation
C Review or print the Levey-Jennings plots, including multi-rule (modified
Westgard) alerts, as applicable
X-B File This key initiates the display of the X-B DISPLAY screen and new labels allowing the
operator to review or print a composite report, including the batch mean for each X-B
parameter — MCV, MCH, and MCHC — calculated for the last 20 batches. Each
stored batch mean is plotted.

Low Control, Normal Control, High Control

The control keys initiate the display of the appropriate CONTROL FILES screen and
new labels allowing the operator to:
• view the control data and statistical information

• manage the control file
• print or transmit the control file
• select Levey-Jennings to view the Levey-Jennings plot
The keys available from the CONTROL FILES screen are described below.
Purge
This function permanently erases data from the control file. After [PURGE] is
pressed, the screen label changes to [RESTORE]. Press [RESTORE] to cancel the
purge. Press [RETURN] to complete the purge.
NOTE Once [RETURN] is pressed, data in the file is permanently erased. [RESTORE] will
not cancel a purge.
Plot Levey-Jennings
This function plots the data using the Levey-Jennings method and calls the LEVEY-
JENNINGS MENU.
When [REJECT] is selected, it removes a specimen from the statistical calculations;

when [ACCEPT] is selected, it restores a specimen that was removed.
Delete Specimen
This function deletes a specimen from the control file. After [DELETE SPECIMEN]
is pressed, the screen labels change to [DELETE SPECIMEN] or [RESTORE
SPECIMEN]. Press [DELETE SPECIMEN] to complete the delete; press
[RESTORE SPECIMEN] to cancel the delete.
Transmit Data
This function transmits the control file to an external computer.

Print Data
This function prints the control file data on the graphics printer.
Replicate 1 through 9
This key initiates a new screen and new labels allowing the operator to access the
desired replicate file and display the data. The keys available from the REPLICATE 1
through 9 MENU are described below.
Purge REPL ––> CONT
This function purges data from the file or copies it into a control file. To copy the
replicate file to a control file, print a copy of each control file (low, normal, and high).
Purge each control file, because the control file must be empty in order to transfer a
replicate file to a control file. Press the key corresponding to the desired control file
([COPY LOW], [COPY NORMAL], [COPY HIGH]). Press [RETURN] to exit the
copy function.
Plot Levey-Jennings
This function displays the Levey-Jennings plots.
When [REJECT] is selected, it removes a specimen from the statistical calculations;

when [ACCEPT] is selected, it restores a specimen that was removed.
Delete Specimen
This function deletes a specimen from the control file. After [DELETE SPECIMEN]
is pressed, the screen labels change to [DELETE SPECIMEN] or [RESTORE
SPECIMEN]. Press [DELETE SPECIMEN] to complete the delete; press
[RESTORE SPECIMEN] to cancel the delete.
Transmit Data
This function transmits the control file to an external computer.

Print Data
This function prints the control file data on the graphics printer.
Quality Control Guide

General Information
The first section of the guide gives information about running controls and guidelines
for basic assay verification. The section on Westgard Rules defines the rules used and
gives guidance for their application in the hematology laboratory. The commercial
controls, replicate specimen, and X-B analysis programs are discussed in detail in the
last section.
All QC data should be reviewed according to your laboratory's protocol. Refer to the
appropriate sections in this chapter for suggestions and guidelines for interpreting the
results.
Running Controls
Control Material Abbott recommends using the CELL-DYN control materials for performing quality
control checks on the CELL-DYN 1600. These controls should be run:
• after calibration (confirmatory step)

• after Daily Start-up procedures are completed
• after a reagent lot number change
• after maintenance, a service call, or component replacement
• in accordance with the laboratory's quality control protocol
• according to regulatory requirements
The controls may be run in either open mode or CS mode.
NOTE A procedure for using patient samples to verify closed mode performance is given in
the Closed Sample Aspiration Module section of this manual.
To ensure accuracy of the results when commercial control specimens are run:
• Verify the control's condition when it is received. Confirm that vials are cold and
not leaking. Check for hemolysis.
• Always resuspend according to the control manufacturer's recommendations.
• Never use an open vial longer than is recommended by the manufacturer.

$ Verify values for the new lot of control by running each level as described
in the "Assay Verification" section, along with either replicate QC
specimens or the old control when it is still in date.
$ When results for any parameter(s) are flagged (outside of entered limits),
reconfirm calibration for that parameter using specimens with known
reference values. When calibration verification results are acceptable, either
establish a new working mean and limits for each level of the new lot of
control or call the Abbott Customer Support Center.
CAUTION If the System has been idle for 15 minutes or more, a normal background should be
run immediately prior to running any control specimens.
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:
$ 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-vial stability dating and do not use products longer than is
recommended or results may be compromised.
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 lot of controls
twice a day for five days using any empty replicate files. The replicate files calculate
the mean, standard deviation and coefficient of variation for each stored parameter.
The instrument-calculated means of these ten runs should be within the expected
ranges published by the manufacturer.
Replicate files may be set up for the new lot number to easily establish the mean
values. However, the replicate files store only the absolute values for the three-part
differential. If you wish to validate the differential percents (LYM, MID, GRAN),
refer to the instructions given in the next section.
The expected ranges published by manufacturers are generally too broad for effective
quality control.1 Therefore, your laboratory's established means and SDs for the new
controls lots should be edited into the appropriate Quality Control file when new lots
are placed into daily use. As a result, these ranges will now be used by the system to
automatically monitor all parameters for each control run. 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:
2 2 2
(N1 × SD1 )%(N2 × SD2 )%...(Ni × SDi )
Average SD =
(N1 % N2 % ...Ni) & 1
N = number of values in a group

SD = standard deviation of the values
i = the last group of values
The resultant long-term instrument SD and the laboratory-established mean for each
lot number should be used to monitor instrument performance.
Differential Percent Verification

The differential percents (LYM, MID*, GRAN) are not stored in the Quality Control
Logs. If statistical analysis of these parameters is required, it needs to be performed
manually.
The replicate files store only the absolute values for the three-part differential. To
validate the differential percents, manually record the values from the RUN screen
display or from a printout of each control run. The differential percentage data can
then be used to calculate the mean values. These mean values (absolute values and/or
percent values), in conjunction with the laboratory's established SDs, may be used to
monitor the performance of a given lot of control material.
*Referred to on the assay sheet as Mono.
Westgard Rules
Introduction A control file tests the control result against control limits to determine whether the
CELL-DYN 1600 shows acceptable accuracy and precision. The limits are derived
from the mean and standard deviation of control measurements obtained when the
instrument performance is stable and acceptable. The most common rule used in
hematology quality control is the mean ± 2SD limits. 95% 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.

CELL-DYN 1600 Westgard Rules
The rules may be used singly or in combination depending on the operator preference.
Selections are made on the QC FILE SETUP screen.
When a rule is violated, the bulletin line displays the <WESTGARD WARNINGS:
SEE LEVEY-JENNINGS> message. The number of the rule that was violated is
displayed in place of the plus sign.
The modified Westgard Rules available on the CELL-DYN 1600 are:
Rule 1: Value outside 3SD

A control result exceeded the mean " 3SD.
Rule 2: 2 consecutive values outside the same 2SD

2 consecutive results fell outside 2SD on the same side of the mean.
Rule 3: 2 consecutive values outside opposite 2SD

1 result was greater than 2SD above the mean and the next result was
greater than 2SD below the mean. Consequently, the range between the
results is greater than 4SD.
Rule 4: 2 of 3 consecutive values outside the same 2SD

2 of the last 3 results fell outside 2SD on the same side of the mean.
Rule 5: 4 consecutive values outside the same 1SD

4 consecutive results fell outside 1SD on the same side of the mean.
Rule 6: 12 consecutive values on the same side of the mean

12 consecutive results fell on the same side of the mean.
Rule Violations Only the directly measured parameters need to be monitored with multiple rules.1 In
reference 1, (pp. 190-192), Cembrowski suggests a protocol for using the Westgard
Rules in hematology. Following is a synopsis of that protocol.
Since 3 levels of control are typically used to monitor a hematology analyzer, it is

reasonable to consider all 3 runs at the same time. In other words, check for the rule
violations across the 3 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 3 levels first be checked to see if they are
within their 2SD limits. If all 3 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 is either an instrument problem or a problem with the
particular level of control. Therefore, if a result exceeds 3SD, run another vial of that
control. If the problem persists, then additional investigation is required.
Check to see if either Rule 3 or Rule 4 has been violated for any level or across levels.
If the problem is confined to one level of control, check for a Rule 2 violation for that
level. Again, if the violations are confined to one level of control, use another vial and,
if possible, 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 3 levels, determine whether the
violations indicate a loss of precision or a loss of accuracy, and troubleshoot
accordingly. If necessary, call the Abbott Customer Support Center for assistance.
When the problem has been resolved, Cembrowski suggests that all levels be run again
in duplicate to confirm that it has in fact been corrected.
Commercial Controls QC Program

A specific file (low control, normal control, or high control) is designated for each
level of a commercial reference control: low abnormal, normal, high abnormal,
respectively. Data is stored in the appropriate file for 30 runs.
Specific multi-rules are activated or deactivated for each file via SETUP. Printed
package insert reference mean and limits, the lot number, and the expiration date for
control specimen in each file is also entered via SETUP. Parameter data obtained for
any control run that falls outside of these entered limits display in inverse video and
print underlined to alert the operator.
QC file summary data or Levey-Jennings plot data currently in each file can be
displayed and printed. Each time a QC specimen is run, the mean, standard deviation,
and coefficient of variation for each parameter is calculated and updated automatically
for current run data in each file. The operator can, at any time, reject any run with
flagged (outside entered limits) data from this calculation. Additionally, the operator
can delete any run from a QC file.

Replicate Specimen QC Program

Nine separate files are available for this program. Numeric data for each parameter,
for up to 30 runs, stores in each file and can be displayed or printed at any time.
Alerts, calculations, and plots are the same as those stated above for the commercial
control QC program. SETUP is used to activate or deactivate the Westgard Rules and
to enter comparison data.
X-B Analysis QC Program

Introduction X-B analysis is an automated means of monitoring instrument performance by using
the known stability of the red cell indices.
X-B represents the moving average of hematology values calculated using an

algorithm developed by Dr. Brian Bull. The X-B analysis uses the Bull algorithm to
monitor instrument performance by tracking the average red cell indices in the patient
population analyzed on the instrument.
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 varies 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% from day to day and even year to year, providing the population does
not change. The X-B algorithm provides a means of utilizing this information for
quality control on the CELL-DYN 1600.
The X-B algorithm analyzes the indices for MCV, MCH, and MCHC on the patient
samples run through the instrument in batches of 20. Current batch data are then
"smoothed" by using the mean from the previous batch multiple times in the
calculation. As a result, each newly calculated batch mean includes data from previous
batches.
When the X-B program is ON and the patient specimen type is selected, the third line
of the RUN screen displays the current X-B program status (e.g. <TYPE: PATIENT
X-B: N/IN>; N is the number in the current batch and IN indicates the last batch was
within the target and limits for all three parameters). In the DATA LOG, a B in front
of a sequence number identifies each patient specimen accepted in the current X-B
batch.

9140214 Rev F—April 1996
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 or background counts 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 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.
Establishing the Target Value

A recent study2 by Dr. Bull collected data from 1767 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 published in an earlier study3. Consequently,
the values shown above can be used as the Target Values to initiate the X-B Analysis
program.
To establish setup X-B target values for MCV, MCH, and MCHC:
1. Turn the X-B moving average ON in SETUP.
2. At the X-B file setup, enter:
• 90. for MCV

• 30.5 for MCH
• 33.9 for MCHC
Laboratories seeing specialized patient populations, e.g., pediatric hospitals or tumor

centers, may need to verify these values due to "abnormal" patient populations. Target
values may be verified by evaluating approximately 400 samples and comparing the
X-B means for those samples to the entered target values. This can be done as follows:

9140214 Rev F—April 1996
1. Collect data for a minimum of 20 batches. Calculate the mean, SD, and CV for
each index using the batch means. The CV on 400 samples (20 batches) for each
index should be less than 1.5%. (The 1.5% is one-half the allowable ± 3%
action limit.) If the CVs are greater than 1.5%, an additional 400 samples
should be evaluated.
2. If the CVs calculated in Step 1 are less than 1.5%, enter the mean as the
confirmed target value.
Interpreting X-B 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.4
CELL-DYN Controls
The CELL-DYN controls are packaged as follows:
• Tri-level, 1 box, 2.5 mL vials x 12

• Tri-level, 1 box, 3.0 mL tubes x 12
References 1. Cembrowski GS, Carey RN. Laboratory quality management, pp. 189, 190-
192.
2. Bull BS, Jones AR, Gibson M, Twedt D. A method for the independent
assessment of the accuracy of hematology whole blood calibrators. AJCP
(accepted for publication), 1992.
3. Bull BS, Hay KL. Are red blood cell indexes international? Arch Pathol Lab
Med 1985; 109:604-606.
4. Chanarin I, ed. Laboratory hematology, an account of laboratory techniques.

Edinburgh: Churchill Livingston, 1989:3-7.


Chapter 8 Precautions, Limitations and Hazards
Precautions, Limitations and Hazards

Limitations • The CELL-DYN® 1600 is designed for in vitro diagnostic use.
• Abbott has designed the CELL-DYN 1600 system components for optimal
performance. Substitution for reagents, calibrators, controls and components
manufactured by other companies may adversely affect the performance of the
Analyzer.
• Follow the recommended maintenance schedules and procedures as outlined in

Chapter 9, Maintenance, of this manual.
• During the warranty period, all services and repair must be performed by
Abbott authorized representatives.
CAUTION Testing has shown that precision within stated claims is best maintained by
priming the system after a specified idle time. Therefore, if the system has
been idle for 15 minutes or more, a normal background should be run to
ensure that the system is primed immediately prior to running any specimens.
Location Requirements
• An Abbott authorized representative must install the instrument.
• Place the CELL-DYN 1600 Analyzer on a hard, level surface. Locate the
system:
– Away from direct sunlight
– Away from the path of a cooled or heated air outlet
– Away from drying ovens, centrifuges, x-ray equipment, CRTs or
computers, video terminals, copiers, and ultrasonic cleaner.
• Do not place reagent containers above the instrument.
• The following space should be available to ensure proper ventilation:
– Benchtop space: 3 to 4 linear feet plus sufficient space for reagents

– Behind the instrument: 4 to 6 inches of space for proper ventilation
– Adequate space should be provided around the analyzer to perform
necessary maintenance procedures.
• Care should be taken to prevent blocking of the air vents on the sides and the
back of the analyzer.
• Before operating the instrument for the first time, verify that each reagent line
is connected to the appropriate inlet and reagent container.

Precautions, Limitations and Hazards Chapter 8
• 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 the waste is routed to a
drain, make sure a dummy plug is inserted in the waste sensor connector.
Electrical Safety Precautions

• Do not disconnect any electrical connection while the power is ON.
• For continued protection from electric shock, use only approved power cords
(such as those supplied). Connect power cords only to properly grounded
outlets.
WARNING Do not remove any instrument panel that is securely fastened in place by screws.
Electrical shock hazard is increased whenever these panels are removed.
• Replace only the externally accessible, labeled fuse located near the power
cord connector. Use replacement fuse of the specified type and electrical rating
only. Refer to Chapter 10, Troubleshooting, for detailed instructions.
Mechanical Safety Precautions

CAUTION Avoid contact with needle tips at all times (CS model) to prevent possible
contamination with potentially infectious materials.
• Wear gloves and safety glasses and use extreme caution when performing any
maintenance procedures on the following components, as they can pinch or
puncture:
– Aspirate probe
– Closed Sampler Needle (CS model)
Infection Control
• Consider all clinical specimens and controls, calibrators, etc., that contain
human blood or serum as potentially infectious. Use established, good,
laboratory working practices when handling these samples. Wear gloves, lab
coats and safety glasses and follow other biosafety practices as specified in the
OSHA Bloodborne Pathogen Rule or other equivalent biosafety procedures.
• Do not smoke, eat or drink in areas where test samples are handled. Do not
pipette by mouth.

Chapter 8 Precautions, Limitations and Hazards
Decontamination Procedures
• Decontaminate the instrument by performing the Auto-Clean cycle. This cycle
flushes all of the fluid pathways with reagents to purge any waste from the
fluid pathways. (The Open Sample Aspiration Probe and the CS Needle are
automatically rinsed after every cycle.) The surfaces of the instrument should
be wiped with a non-abrasive detergent solution to remove any soiling. This
should be followed with a wipe with a 10% chlorine bleach solution.
• If the instrument is to be shipped, it must be decontaminated prior to shipment.

This is accomplished by the [PREPARE SHIPPING] key in the SPECIAL
PROTOCOLS MENU. Instructions are given in the Non-Scheduled
Maintenance section of Chapter 9, Maintenance.
Blood Samples
• Decontaminate and dispose of all specimens and potentially contaminated
materials in accordance with local, state, and federal regulations.
• Waste liquid is a possible source of biological and chemical hazard. Handle

with extreme care during the disposal process.
• Refer to the Sample Collection and Handling section in Chapter 5, Operating

Instructions, for precautions and limitations pertaining to sample collection and
handling. This section also includes information on interfering substances.
Spills
Clean up spills of potentially infectious materials in accordance with established
biosafety practices. A generally accepted procedure for clean up of such spills is to
absorb the spill with toweling or other absorbent material, wipe the area with a
detergent solution and then wipe the area with an appropriate hospital disinfectant
such as 10% chlorine bleach.

9140214 Rev DCJune 1993
Precautions, Limitations and Hazards Chapter 8
Reagent Storage and Handling

• Store reagents, calibrators and controls according to the directions in the
enclosed package inserts.
• Protect reagents from extreme heat and freezing during storage. Temperatures
below 32oF (0oC) may cause layering that changes the tonicity and
conductivity of the reagent. If freezing occurs, do not use the reagent.
• Protect reagents from direct sunlight, evaporation and contamination. Use of

the reagent container cap attached to each inlet tubing minimizes the latter two
occurrences.
• Never add remaining reagent from a container being replaced to a freshly

opened container. This may contaminate the new reagent.
• Never use a hemoglobin standard designed for use with reference

cyanmethemoglobin methodology directly on the CELL-DYN 1600. The
CELL-DYN 1600 uses a modified hemiglobincyanide method which is not
designed to analyze these standards directly.
Printer Precautions
The printhead can get very hot during extended periods of printing. Allow it to cool
before touching.

9140214 Rev DCJune 1993
Chapter 9 Maintenance
Maintenance
Introduction The CELL-DYN® 1600 analyzer is designed to require minimal routine maintenance.
For example:
! The fluidics are automatically rinsed between samples.

! The instrument is automatically placed in standby if it has been idle for 4 hours
after the last cycle is completed.
The operator is encouraged to routinely perform the required maintenance to lengthen

the operational life of the analyzer and to minimize system problems that lead to
imprecision and inaccuracy. This chapter describes the recommended preventive
maintenance procedures and provides instructions for preparing the analyzer for an
extended period of inactivity.
NOTE Following maintenance, run commercial control or quality control (QC) specimens to
confirm proper performance before running any unknown specimens.
Many required preventive maintenance procedures have been automated on the CELL-
DYN 1600. These programs are accessed by pressing [SPECIAL PROTOCOLS] on
the MAIN MENU. The SPECIAL PROTOCOLS screen is discussed in the next
section.
WARNING Consider all clinical specimens and controls, calibrators, etc. that contain human blood
or serum as potentially infectious. Use established, good laboratory working practices
when handling these samples. Wear gloves, lab coats and safety glasses and follow
other biosafety practices as specified in the OSHA Bloodborne Pathogen Rule or other
equivalent biosafety procedures.
CAUTION Wear powder-free gloves when performing the maintenance procedures. If powder-
free gloves are not available, rinse the gloves before performing the maintenance
procedures. Powder from the gloves may cause instrument problems.

9140214 Rev DCJune 1993
Maintenance Chapter 9
Following outlined maintenance schedules minimizes operational problems with the

CELL-DYN 1600. The recommended intervals are based on the analyzer 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 imprecision of one or more of the directly
measured parameters. This imprecision is due to carryover or dilution/sampling
inconsistencies. If this occurs on more than a random basis, perform the appropriate
maintenance more frequently than indicated.
Special Protocols Menu

The SPECIAL PROTOCOLS screen is the main screen used during maintenance
procedures. It is accessed from the MAIN MENU by pressing [SPECIAL
PROTOCOLS].
Preventive Maintenance Schedule

Perform the following procedures at the scheduled time intervals.
Daily 1. Daily shutdown (page 9-3)
Weekly 1. Open sampler auto clean (page 9-4)
2. Aspiration probe exterior cleaning (page 9-5)
3. Closed sampler auto clean (for the CS model only) (page 9-6)
4. Closed sampler holder cleaning (for the CS model only) (page 9-7)
Monthly 1. Lyse inlet tubing rinsing (page 9-8)
2. Rear fan filters cleaning (page 9-9)
NOTE To prepare for prolonged shutdown, refer to page 9-4.

9140214 Rev DCJune 1993
As Required (for troubleshooting or corrective action)
See the Nonscheduled Maintenance section for maintenance frequency.
1. Supplemental aperture cleaning (page 9-11)
2. Aperture plates cleaning (page 9-13)
3. Diluent syringe cleaning (page 9-16)
4. Sample syringe cleaning (page 9-19)
5. Sample aspiration probe interior cleaning (page 9-22)
6. HGB flow cell manual cleaning (page 9-24)
7. Vent line cleaning (page 9-26)
8. Accumulator draining and cleaning (page 9-27)
9. Preparing the analyzer for a prolonged period of non-use or for shipping (page
9-28)
10. Aspiration probe removal and replacement procedure (page 9-29)
Daily Maintenance Procedures

Daily Shutdown Procedure
1. At the MAIN MENU, press [SPECIAL PROTOCOLS]. A new screen and

new labels appear.
3. Press [DAILY SHUTDOWN] to begin this cycle. <Process Active> appears

on the screen. The Daily Shutdown cycle takes approximately 3 minutes.
4. Remove the lyse pump tubing from under the lyse pump rotor on the left side.
5. Record this maintenance in your maintenance log.
NOTE When the cycle is complete, the analyzer should be left with the power ON. If so,
reduce the screen brightness (by using the knob on the right side panel) to reduce the
risk of burning the screen. If the instrument will not be used again within 24 hours,
turn the power OFF.

9140214 Rev DCJune 1993
To prepare for prolonged shutdown:
When the power will be turned OFF for more than 72 hours, perform the following
procedure:
1. Remove the tubing from the lyse reagent container.
2. Perform the lyse inlet tube rinsing procedure. See the Monthly Maintenance
section.
3. Immediately after the power is turned OFF, remove the following:
! Lyse pump tubing from under the lyse pump rotor on the left side.
! Tubing inserted in the normally closed (black octagon) valve at the top
left side of the flow panel under the upper front cover.
! Tubing from the normally closed (black octagon) valves on the left side.
WARNING Do not forget to reinsert the tubes securely in the normally closed valves and under the
lyse pump rotor (see Chapter 2, Installation) before turning the analyzer back ON.
Weekly Maintenance Procedures

Open Sampler Auto Clean
Materials Required
CELL-DYN Enzymatic Cleaner (at room temperature)
Procedure

new labels appear.
2. Press [AUTO CLEAN] to begin this cycle.
3. Place the vial of undiluted enzymatic cleaner concentrate under the sample
probe.
4. Press [START CLEAN]. <Process Active> appears on the screen. The

complete cycle takes approximately 11 minutes.
5. When the cycle completes, press [MAIN] to return to the MAIN MENU.

9140214 Rev DCJune 1993
6. Run background counts until acceptable results are obtained for all
background parameters.
7. Run commercial controls or QC specimens to confirm the proper performance

before running any unknown specimens.
Aspiration Probe Exterior Cleaning
Materials Required

Gauze pad/DYN-A-WIPETM
Distilled water
Procedure
During each run cycle, the wash block rinses whole blood from the outside of the
aspiration probe. However, routinely clean and disinfect the outside of the probe to
ensure it moves freely through the wash block. This procedure can be done at any time
(at least weekly) or in conjunction with other routine cleaning procedures.
1. With the power ON and aspiration probe down, carefully wipe the outside of
the probe several times with a gauze dampened with diluted enzymatic cleaner.
2. Wipe the outside of the probe with a gauze dampened with distilled water.
OR
Run a background to rinse the probe.

9140214 Rev DCJune 1993
Closed Sampler Auto Clean
Materials Required

Red top Vacutainer® tube (with no anticoagulant)
Lint-free towel
Procedure
1. Insert the tip of the enzymatic cleaner into the Vacutainer tube and fill it 3/4
full with cleaner.
2. Wipe the top of the Vacutainer tube with a lint-free towel to remove any excess
cleaner and insert the stopper.
NOTE Enzymatic cleaner is extremely slippery and any cleaner on the stopper or the top of
the Vacutainer tube can cause the stopper to come off.

new labels appear.
4. Confirm that the stopper is securely inserted on the Vacutainer tube containing
the cleaner. Invert the tube and insert it into the closed sampler holder.
5. Press [START CLEAN]. <Process Active> displays on the screen. The Closed
Sampler Auto Clean procedure takes approximately 8 minutes.
6. At the beep, remove the sample from the closed sampler holder.
9. Run commercial controls or QC specimens to confirm proper performance


9140214 Rev DCJune 1993
Closed Sampler Holder Cleaning
Materials Required
CELL-DYN Enzymatic Cleaner (at room temperature) or 5% sodium hypochlorite

Cotton tip applicator
Lint-free towel
Procedure
The closed sampler holder can be cleaned automatically via [CLEAN SAMPLER]
from the SPECIAL PROTOCOLS screen. This key also aspirates liquid and spilled
blood or cleaning fluid from inside the holder. A cotton tip applicator can also be used
to clean the inside of the tube holder.
WARNING The tube holder contains a needle that presents a potential for injury when the operator
places his or her fingers or hand in the path of the needle.
1. Swing the closed sampler holder arm to the side for better visibility of the well.
2. Insert the tip of the enzymatic cleaner into the inner well and fill it 3/4 full with
cleaner.

new labels appear.
5. Press [CLEAN SAMPLER]. <Process Active> appears on the screen.
NOTE Look for two parallel streams of diluent that flush the inner well.
6. Moisten a cotton tip applicator with enzymatic cleaner. Insert the tip into the
inner well and clean the inner surface.
7. Press [CLEAN SAMPLER]. <Process Active> appears on the screen.

Monthly Maintenance Procedures

Lyse Inlet Tubing Rinsing
Materials Required
Medium size beaker

Deionized water
Procedure
Replace the lyse pump tubing with the spare lyse pump replacement tubing at least
every three months to ensure that it does not become pinched or restricted.
NOTE If lyse pump tubing is replaced, verify lyse volume. Refer to Calibration,
Chapter 6.
IMPORTANT When the power is going to be turned OFF for 72 hours or longer, refer to Daily
Maintenance Procedures, To prepare for prolonged shutdown, for additional steps.
1. Remove the lyse tubing from the lyse reagent container and place it into a
container of warm deionized water.

new labels appear.
4. Press [LYSE PRIME] to begin the lyse priming cycle.
5. Press [LYSE PRIME] again a few times to perform multiple "lyse prime"
cycles, which rinses the tubing with warm water.
6. Remove the lyse tubing from the water and press [LYSE PRIME] to cycle air
through the tube.
A. To continue operation immediately:
1. Reinsert the tube into the lyse reagent and press [CLEAR
ALARM]. Watch the Lyse Inlet tubing to verify lyse flow.

2. Perform 2 or 3 lyse prime cycles by pressing [LYSE PRIME].
4. Run commercial controls or QC specimens to confirm proper

performance before running any unknown specimens.
B. To prepare for prolonged shutdown (power OFF for over 72 hours):
1. Turn MAIN power switch OFF.
2. Perform Step 3, Chapter 9, Maintenance, Daily Maintenance

Procedures, Daily Shutdown, To prepare for prolonded
shutdown, to complete shutdown procedure.
Rear Fan Filters Cleaning
Materials Required
Lint-free towels
Procedure
Rear cover fan filters are used to clean air passing through each of the rear fans. Clean
them monthly to maintain a constant and unrestricted air flow. More frequent cleaning
is required if the unit is located in a dusty area.
1. Perform a Daily Shutdown procedure to place the analyzer in STANDBY.
2. Turn the power switch to OFF and locate the fan filters on the rear panel.
3. Snap off the plastic frame of each filter.
NOTE Some older model fan filters press off by lightly pressing and rotating the fan filter
counterclockwise until it releases from the bracket notches holding it in place.
4. Remove the filters and run a medium pressure stream of warm water over each
one.
5. Blot dry each filter with lint-free towels.

6. Reinsert the cleaned filter into the bracket.
7. Turn the power switch to ON. After the analyzer is initialized, press [RUN] to
continue.
Nonscheduled Maintenance Frequency
Procedure Frequency
Supplemental When Auto Clean has not cleared a restriction or an
Aperture Cleaning organic build-up is suspected of causing any of the
following:
1. Baseline count times are out of range.
2. Background problems.
3. Frequent clogs or flow errors.
Aperture Plates When neither Auto Clean nor Supplemental Clean have
Cleaning cleared a restriction or an organic build-up is suspected of
causing any of the following:
1. Baseline count times that are out of range.
2. Background problems.
3. Persistent clogs or flow errors.
NOTE If available, use a microscope to verify that
the aperture plate is entirely clean.
Diluent Syringe When it is suspected to be the source of imprecision.
Cleaning NOTE Flaking of the white Teflon® plunger tip
indicates replacement of syringe is necessary.
Sample Syringe This procedure is rarely necessary.
Cleaning Replace the syringe when:
1. It is suspected to be the source of imprecision.
2. Black residue appears on the white Teflon tip.
Sample Aspiration When the sample aspiration probe is suspected to be the
Probe Interior source of imprecision.
Cleaning
HGB Flow Cell When Auto Clean has not cleared away a restriction or an
Manual Cleaning organic build-up is suspected of causing any of the
following:
1. Elevated HGB results
2. HGB imprecision
Vent Line Cleaning When the vent line is restricted and prevents the
formation of a proper meniscus in the metering tube.

Procedure Frequency
Vent Line Cleaning When the vent line is restricted and prevents the formation
of a proper meniscus in the metering tube.
Accumulator 1. When the alarm indicates that the accumulator is
Draining and wet.
Cleaning 2. When background counts exceed specification.
Preparing the 1. Shipping the instrument.
analyzer for a 2. Storing the instrument.
prolonged period of 3. Prolonged period of non-use.
non-use or shipping 4. When the entire plumbing system is suspected as
the source of bacterial or fungal contamination.
Nonscheduled Maintenance Procedures

Supplemental Aperture Cleaning
Materials Required
50% cleaning solution (5 mL of 5% sodium hypochlorite added to 5 mL of warm

water)
Small beaker
Procedure
This procedure is used to remove very stubborn restrictions in the RBC and WBC
apertures, or when there is a marked increase in the RBC and/or WBC count times
that cannot be solved by normal auto cleaning. If this procedure does not solve the
problem, remove and clean the aperture plates.
1. Ensure that the instrument is in the RUN mode and <READY> is displayed in
the Status Box.
2. Remove the upper front cover.
3. Carefully pour the 50% cleaning solution into the pre-mix cup.
4. Carefully pour 5 mL of 5% sodium hypochlorite into the RBC bath.
5. Replace the upper front cover.
6. Wait two minutes to allow the pre-mix cup to soak.
7. After the soak period, press [SPECIMEN TYPE].

9140214 Rev DCJune 1993
8. Press # key on the keyboard. The GAIN ADJUST screen displays. The
cleaning solution in the pre-mix cup is transferred to the WBC bath. Both
baths are bubble mixed. Wait another 2 minutes for the baths to soak.
9. Press the open probe touch plate to run three consecutive count cycles to
aspirate the cleaning solution through the RBC and WBC apertures. If a
<FLOW ERROR> or <CLOG> message displays, ignore it and continue to
run the three counts.
NOTE DO NOT use [CLEAR ORIFICE] because it will drain the cleaning solution from the
cups.
10. Press [SPECIMEN TYPE].
11. Press [NORMAL BACKGRND].
12. Press [CLEAR ORIFICE] to reset the Running Average program and drain the
baths.

The instrument is ready to run samples. It is recommended that the RBC and WBC
count times be recorded for future reference to monitor protein build-up in the
apertures.

9140214 Rev DCJune 1993
Aperture Plates Cleaning
Materials Required
CELL-DYN Enzymatic Cleaner (at room temperature) or 5% sodium hypochlorite

Sample vial
Small beaker (50 mL)
Camel hair aperture brush (included in the accessory kit)
Deionized water
Procedure
1. Remove the upper and lower front covers. Locate the RBC/PLT bath to the
right of the probe. Locate the WBC bath to the left of the pre-mix cup. (See
Figure 9-1.)
Figure 9-1 Location of Dilution Baths

new labels appear.
3. Press [DRAIN BATHS]. Both sides of each bath drain.

9140214 Rev DCJune 1993
4. Swing the red tagged plate holder (which holds the plates securely in place) to
the right. (See Figure 9-2.)
Figure 9-2 Aperture Plate Installation
5. Grasp the RBC/PLT aperture plate and pull it straight out from the transducer
assembly until it is free of the mount.
6. Remove the WBC aperture plate using the same process.
7. Dispense 40 mL of warm deionized water into a beaker or other suitable

container and add 40 drops of enzymatic cleaner (warm water enhances
enzyme action).
OR
Dispense 15 mL of water into a beaker or suitable container and add 5 mL of

5% sodium hypochlorite.
NOTE Diluted enzyme cleaner or sodium hypochlorite are most effective when they are
prepared fresh each time this procedure is done.
8. Clean debris from each aperture plate by rotating the camel hair aperture brush
provided in the accessory kit.
WARNING Use only the brush provided. Use of other items or brushes will damage the aperture
plate.
9. Place each aperture plate into the beaker of cleaning solution prepared in step
7. Completely immerse each plate in the cleaning solution. Allow the plates to
soak for AT LEAST 5 minutes and NO LONGER than 15 minutes.
10. Remove each aperture plate from the cleaning solution and thoroughly rinse it
with a fine stream of deionized water.

9140214 Rev DCJune 1993
To Reinstall the RBC/PLT Aperture Plate
The RBC/PLT aperture plate is identified with "R/P" etched in the plate and is
installed in the dilution bath to the right of the probe.
1. Position the "RBC/PLT" aperture plate so the notch is on the lower portion of
the edge being inserted into the bath.
2. Insert the aperture plate into the slot between the two sections of the RBC/PLT
dilution bath. Push the plate in until it is completely seated in the bath.
3. With the correct aperture plate placement, swing the red lever to your left to
secure the plate in place. (There will be a slight resistance as you replace the
red lever.)
NOTE Be sure both the RBC/PLT and the WBC aperture plates are installed before filling
the baths.
To Reinstall the WBC Aperture Plate
The WBC aperture plate is identified with "WBC" etched in the plate and is installed
in the dilution bath to the left of the pre-mix cup.
1. Position the "WBC" aperture plate so the notch is on the lower portion of the
edge being inserted into the bath.
2. Insert the aperture plate into the slot between the two sections of the WBC
dilution bath. Push the plate in until it is completely seated in the bath.
3. With the correct aperture plate placement, swing the red lever to your left to
secure the plate in place. (There will be a slight resistance as you replace the
red lever.)
NOTE Be sure both the RBC/PLT and the WBC aperture plates are installed before filling
the baths.
To Fill the Baths
1. Press [REFILL BATHS]. The flow systems are refilled.
2. Reinstall the lower and upper front covers. Press [MAIN] to return to the
MAIN MENU.

9140214 Rev DCJune 1993

before running any unknown specimen.
Diluent Syringe Cleaning
Materials Required
Large basin
Deionized water
Procedure
1. Obtain a large basin or suitable container to hold and soak the syringe. Add 2
to 3 inches of warm tap water to the container.
2. Confirm the analyzer is turned ON and the unit is INITIALIZED or READY.
3. Slide the door on the left side of the analyzer to expose the syringes. The
diluent syringe is the large (10 mL) syringe. The sample syringe is the small
(100 FL) syringe.

new labels appear.
5. Press [CLEAN DIL SYRINGE]. The diluent syringe plunger moves up.

9140214 Rev DCJune 1993
6. Remove the large thumb nut at the bottom of the plunger by holding the
calibration block with one hand and turning the large thumb nut clockwise
(when viewed from above). (See Figure 9-3.)
Figure 9-3 Diluent Syringe
7. Press [RESTORE SYRINGE] to move the black plunger holder down and
allow the syringe to be removed.
CAUTION The plunger moves down, up, and down before stopping.
8. Loosen the small thumb nuts on the syringe holder block by turning them
counterclockwise 2 complete turns. Pull the holder block away from the
syringe to prevent breakage of the luer lock connector. Gently pull the syringe
glass barrel towards you to ensure that it is completely free of the front and
back sections of the syringe holder block.
9. Completely remove the small thumb nuts and front section of the holder block.

9140214 Rev DCJune 1993
10. Hold the syringe by the glass barrel and TURN IT CLOCKWISE (when
viewed from above) to release it from its luer lock fitting.
(See Figure 9-3.)
WARNING Do not pull the syringe forward. Pull straight down.
11. Remove the spring clip from the barrel.
12. Immerse the complete syringe assembly in the container of warm water
prepared in step 1. Allow it to soak for 1 to 2 minutes to dissolve accumulated
salt deposits.
13. Pull the white plastic stopper out of the barrel of the syringe. Pour warm water
into the barrel from the bottom of the syringe.
WARNING Do not pull down, on, or otherwise move the plunger. Never push or pull on the
plunger when the syringe is dry.
14. Remove the plunger from the barrel while the syringe is still immersed in warm
water. Let the barrel and plunger soak in warm water for 5 minutes. Remove
and rinse thoroughly with deionized water. Remove excess water by shaking,
do not wipe.
15. Reassemble the syringe by:
! inserting the plunger tip into the barrel

! inserting the white plug into the barrel
! installing the spring clip on the barrel with the small prongs facing up
NOTE When installing the clip, wedge the larger end of the clip on the lip of the barrel and
the small end against the white plug.
16. Replace the syringe into the luer lock fitting by turning it counterclockwise
(when viewed from above) until it is finger-tight. Do not overtighten.
17. Replace the front section of the syringe holder block. Secure it with the thumb
nuts removed earlier. Install the thumb nut with the smaller diameter facing
upward. Tighten the thumb nuts finger-tight with the beveled edge towards the
holder. Do not overtighten.
18. Press [CLEAN DIL SYRINGE] to move the plunger up. Secure it in the
plunger holder with the large thumb nut removed earlier. Install the thumb nut
with the smaller diameter facing up. Tighten the large thumb nut to finger-tight
while holding the calibration block. Do not overtighten.
NOTE A small gap between the plunger holder and the thumb nut is normal.

9140214 Rev DCJune 1993
19. Press [RESTORE SYRINGE].
20. Press [CLEAN DIL SYRINGE]. Check the syringe action for leaks, bubbles,
and proper movement. Repeat this step if necessary.
NOTE Bubbles may be present during the first filling. If they do not disappear, press
[MORE] twice, then press [REAGENT PRIME] to clear the bubbles.
21. Return to the MAIN MENU and run 2 to 3 background counts. Watch the
syringe action to make sure it fills and dispenses completely.
22. Run commercial controls or QC control specimens to confirm proper

performance before running any unknown specimens.
Sample Syringe Cleaning
Materials Required
Large basin
Deionized water
Procedure

new labels appear.
2. Press [CLN SAMPL SYRINGE].
3. Unscrew the bottom of the sample syringe by turning the bottom of the plunger
counterclockwise (when viewed from above). (See Figure 9-4.)
4. Gently push up on the plunger until it clears the black stage.
5. Unscrew the collar of the syringe by turning the entire syringe clockwise (when
viewed from above).
6. If there are saline crystals around the collar of the syringe, soak the entire
syringe in warm water for 5 minutes. Then, gently pull the plunger rod
completely out of the barrel and allow both pieces to soak for a few minutes.
WARNING Do not touch the tip of the plunger with your hands.

9140214 Rev DCJune 1993
7. Rinse the syringe in deionized water and reassemble. If the syringe needs to be
replaced, a new syringe may be installed. For complete instructions, see the
next section.
NOTE Do not push or pull on the plunger when the syringe is dry.
Figure 9-4 Sample Syringe

9140214 Rev DCJune 1993
To Reinstall or Replace the Sample Syringe
1. Push the plunger in all the way. Draw deionized water into the syringe so that
the entire syringe is filled and the plunger is withdrawn as far as possible.
Check for air bubbles. If there are air bubbles in the syringe, dispense and
redraw water into the syringe. This procedure may have to be repeated several
times to remove the air bubbles.
2. Screw the syringe tip into the fitting on the instrument by turning
counterclockwise (when viewed from above).
3. Gently push up on the plunger until the end of the plunger just clears the stage.
Screw the bottom of the plunger clockwise (when viewed from above) onto the
stage.
4. Press [RESTORE SYRINGE].
5. Press [CLN SAMPL SYRINGE], then press [RESTORE SYRINGE]. Watch

for air bubbles.
If air bubbles are present, press [CLN SAMPL SYRINGE] and [RESTORE
SYRINGE] again. Repeat this process until there are no air bubbles.
6. When the syringe is operating properly and there are no air bubbles, press
[MORE] twice. A new screen and new labels appear.
7. Press [REAGENT PRIME] to prime the instrument before operating.


9140214 Rev DCJune 1993
Sample Aspiration Probe Interior Cleaning
Materials Required
Syringe
Sample cup
Deionized water
Cleaning solution (5 mL of 5% sodium hypochlorite added to 5 mL of water)
Procedure
1. With the power ON, remove the upper cover. Press [RUN] to lower the probe.
2. Hold the 1/32" silicone tubing and carefully pull up on the 1/16" straight
connector until it is free of the probe. (See Figure 9-5.)
Figure 9-5 Sample Aspiration Probe Assembly
NOTE Do not loosen the alignment guide.
3. Remove the silicone tubing from the top of the aspiration probe.
4. Using a syringe filled with cleaning solution, flush the probe from the top.
Make sure a sample cup is placed beneath the probe to catch the rinse solution.

9140214 Rev DCJune 1993
5. Using a syringe filled with deionized water, rinse the probe several times from
the top.
6. Reinsert the tubing into the probe and connector.


9140214 Rev DCJune 1993
HGB Flow Cell Manual Cleaning
Materials Required
Syringe cup (10 to 20cc with at least 3" long silicon tubing attached to tip)
Cleaning solution (equal parts of 5% sodium hypochlorite and water)
Wire solenoid valve-puller
Deionized water
Procedure
1. From the MAIN MENU screen, press [SPECIAL PROTOCOLS].
2. Press [DRAIN BATHS].
3. Remove the front panels.
4. Locate the HGB flow cell (located at the bottom left corner) and trace the top
black tubing ending at the T-fitting.
NOTE Do not tug on or place any undue stress on the other end of the black tubing's entrance
point into the flow cell.
5. Disconnect the tubing on the right side of the T-fitting and attach a cleaning
solution-filled syringe to the open end of the T-fitting. (See Figure 9-6.)
6. Attach the wire puller to pinch valve #26.
7. While holding the syringe base with your left hand, pull open valve #26 with
your left index finger.
8. With the right hand push in the syringe plunger.
9. Inject at least 3/4 of the solution into the flow cell.
10. Alternately move the syringe plunger in and out several times to ensure
optimum rinsing action. Leave the solution in the flow cell for 3 to 5 minutes.
11. Remove the syringe.
12. Drain the solution from the flow cell by pulling open valve #26.
13. Using deionized water, perform the same syringe injection procedure (steps 7
through 12) to flush out the solution thoroughly.

9140214 Rev DCJune 1993
14. Reconnect the tubing to the T-fitting.
15. Remove the wire puller.
16. Press [FILL BATHS].
17. Return to the MAIN MENU screen.
18. Run at least 2 backgrounds to ensure acceptable results for all parameters.

Figure 9-6 HGB Flow Cell Manual Cleaning

9140214 Rev DCJune 1993
Vent Line Cleaning
Materials Required
Sample vials
OR
2 small beakers
Deionized water
Procedure
1. Locate the vent lines on both sides of the flow panel. Follow them to where
they come to rest on the bottom.
2. Immerse the lines in a beaker or vial of deionized water.
NOTE Because of their location, it will probably be necessary to use two containers of water.
3. Run backgrounds 2 times. Ignore any <FLOW ERROR> or <CLOG>

messages.
4. Remove the lines from the water.
5. Run backgrounds to clear out the water.

9140214 Rev DCJune 1993
Accumulator Draining and Cleaning
Materials Required
Large syringe
Large beaker
Deionized water
Procedure
1. Turn the analyzer OFF.
2. Locate and unclamp the accumulator tubing beneath the lyse pump assembly
on the left side of the instrument.
3. Pull the plug and drain the tubing into an empty beaker.
4. Aspirate any remaining fluid from the tubing with an empty syringe.
5. Fill the accumulator with 400 to 500 cc of deionized water with a syringe.
NOTE Due to the size of the syringe it may be necessary to clamp the lines and refill the
syringe several times.
6. Open the clamp and drain the accumulator.
7. Use an empty syringe to aspirate any remaining water from the accumulator.
8. Clamp and replace the tubing.
9. Turn the instrument ON and reinitialize.
10. Run enough backgrounds (at least 2 or 3) to secure acceptable results for all

9140214 Rev DCJune 1993
Preparing the Analyzer for a Prolonged Period of Non-Use or for Shipping
Materials Required
Deionized water
Cardboard disk drive protector
Disinfectant (cleaning solution); 1 part 5% sodium hypochlorite added to 9 parts
deionized water
Large beaker
Plastic bag
Procedure
Salt deposits and reagent residue may damage the flow system if not removed before
the CELL-DYN 1600 is stored (idle for two weeks or longer) or shipped.

new labels appear.
3. Press [CLEAN FOR SHIPPING]. The prompt screen displays.
4. Follow the screen prompts to rinse the flow system with deionized water.
5. Follow the screen prompts to purge water from the flow system.
6. Remove the lyse pump tubing from the lyse pump rotor.
7. Turn the power OFF.
8. Carefully remove the tubing from the normally closed (black octagon) valve on
the upper left flow panel.
9. Remove each diluent and detergent inlet tube from its normally closed (black
octagon) valve on the lower left side panel.
10. Remove the lower left side panel inlet and outlet tubing. The waste line should
be emptied and rinsed with disinfectant. Place each tube in the protective bag.
Place the bag in the accessory kit. Wipe the surface of the instrument with
disinfectant.
11. Remove the diskette from the disk drive and insert the cardboard disk drive
protector into the drive.
12. Remove the power cord from the outlet receptacle and rear cover connector.
Place it in the accessory kit.

9140214 Rev DCJune 1993
Aspiration Probe Removal and Replacement
For additional information, see Figure 9-5.
Materials Required
3/32" Allen wrench (provided in the accessory kit)

Replacement probe
Procedure
1. Remove the upper cover.
NOTE Make sure the aspiration probe is down before continuing this procedure. If it is not
down, press [RUN] to lower it.
2. Hold the 1/32" silicone tubing and carefully pull up on the 1/16" straight
connector until it is free of the probe.
3. Remove the probe holder clip.
NOTE On older models, a second Allen screw was used to hold the probe in place. For these
systems, follow steps 3.A. and 3.B.
CAUTION Do not loosen the Allen screw on the probe alignment guide. See Figure 9-5.
A. Use the 3/32" Allen wrench provided in the accessory kit to loosen the #4
Allen screw in the probe holder.
B. Loosen the screws located on top of the wash block that hold the
O-ring in place.
4. Grasp the probe at the top and pull it up until it is free of the wash block.
WARNING If the probe is bent or unable to be removed from the top, hold the probe to steady it.
Remove the collar from the top of the probe. Pull down on the probe until it is free of
the wash block. The probe collar determines the proper probe alignment and is factory
set. Do not loosen the Allen screw in the collar of the replacement probe.
5. Insert it from the top into the probe holder and wash block.
6. With the collar flush with the probe holder, reinstall the probe holder clip with
the curved portion down.
NOTE For older models, tighten the Allen screw on the probe holder.

9140214 Rev DCJune 1993
7. Hold the probe to steady it and insert the 1/16" straight connector completely
into the 1/32" silicone tubing.
8. Reinstall the upper front cover.


9140214 Rev DCJune 1993
Chapter 10 Troubleshooting
Troubleshooting
Introduction This chapter gives instructions for identifying, troubleshooting, and correcting
instrument problems. The CELL-DYN 1600® continuously monitors the status of the
system and displays pertinent information in the status box. If a problem is detected
within the system, the status box displays a message such as <LYSE EMPTY>,<
WASTE FULL>, or <CLOG>. If a problem with the hardware occurs, the message
<NOT READY. SEE DIAGNOSTICS> is displayed.
The first section of this chapter discusses the DIAGNOSTICS MENU keypad labels.
The remainder of the chapter is devoted to the Troubleshooting Guide.
Diagnostics This section describes the keypad labels available from the four DIAGNOSTICS
MENU screens when the instrument is initialized and primed. These keys enable the
operator or service representative to obtain information and execute programs that
assist in troubleshooting and to identify corrective action.
When some keys are pressed, the message <FOR SERVICE USE ONLY> is
displayed. The data these keys provide are meaningful only to trained field engineers
and are not useful to the operator. If these keys are pressed inadvertently, the system
may have to be initialized.
The main DIAGNOSTICS MENU includes the following keys:
[SYSTEM STATUS]
[FAULT REPORT]
[SERVICE HEX CODES]
[SERVICE DEC CODE]
[MORE]
[PRINTER OUTPUT]
[HELP]
[MAIN]
Each of these keys is described below.
System Status [SYSTEM STATUS] displays a new screen that allows the operator or service
personnel to review or print the current system status.
Fault Report [FAULT REPORT] displays a new screen that allows the operator or service
personnel to review or print the current fault status. Whenever the message <NOT
READY. SEE DIAGNOSTICS> is displayed in the system status box, it is directing
the operator to go to the diagnostics mode and press this key.
Service Hex Codes This screen is not for operator use. It is for service personnel only.

9140214 Rev DCJune 1993
Troubleshooting Chapter 10
Service Dec Code This screen is not for operator use. It is for service personnel only.
More [MORE] displays a new screen and keypad labels that allow the operator to perform
additional diagnostics to assist in troubleshooting. This key performs the same
function on all diagnostic menus.
Printer Output [PRINTER OUTPUT] allows the operator to print any screen by turning the printer
output on before pressing another screen label. This also toggles the printer output
OFF. The current printer status is displayed in the upper left section of the screen.
This key performs the same function on all diagnostic menus.
Help [HELP] steps the operator through one or more Help screens that define the screen
keypad labels and the procedures to be performed. This key performs the same
function on all menus.
Main [MAIN] takes the operator back to the MAIN MENU and performs the same function
on all diagnostic menus.
When [MORE] is pressed, the second of four DIAGNOSTICS MENU screens is

displayed. The following keys may be selected:
[INITIALIZATION]
[RAW DATA]
[COUNT TEST]
[MORE]
[PRINTER OUTPUT]
[HELP]
[MAIN]
These new keys are described below.
Initialization [INITIALIZATION] is used to perform an initialization cycle. In the process, all

motors are returned to the "home" position and all circuitry is checked.
Raw Data [RAW DATA] displays the raw measurement data for the last specimen analyzed.

9140214 Rev DCJune 1993
Count Test [COUNT TEST] is used to run a specimen and to display the count test data. The
user is directed to place the specimen under the probe and to press [START]. The
count test can also be used in the pre-dilute mode.
Code data relating to specific cycle functions, raw measurement data, and flow count
time data are displayed for use in troubleshooting or service.
When [MORE] is pressed, the third of four diagnostic menus is displayed.

The following keys may be selected:
[WBC HISTOGRAM]
[RBC HISTOGRAM]
[PLT HISTOGRAM]
[SMOOTHING OFF]
[MORE]
[PRINTER OUTPUT]
[HELP]
[MAIN]
These keys are described below.
WBC Histogram [WBC HISTOGRAM] is used to print the lysate-modified white cell count (numeric)
data accumulated in each of 256 size channels. Each line contains data for 16
channels. For example, line 1 data are for channels 1 to 16, line 2 data are for channels
17 to 32, etc. Each size channel equals 1.367 femtoliters.
RBC Histogram [RBC HISTOGRAM] is used to print the red cell count (numeric) data accumulated
in each of 256 size channels. Each line contains data for 16 channels. For example,
line 1 data are for channels 1 to 16, line 2 data are for channels 17 to 32, etc. Each
size channel equals 1 femtoliter.
PLT Histogram [PLT HISTOGRAM] is used to print the platelet count (numeric) data accumulated in
each of 256 size channels. Each line contains data for 16 channels. For example, line 1
data are for channels 1 to 16, line 2 data are for channels 17 to 32, etc. Each size
channel equals 0.1367 femtoliters.
The histograms are displayed as numeric data and printed as graphic curves on the
graphic printer. Alphanumeric data are printed if a ticket printer is connected to the
graphic printer port.
Smoothing Off [SMOOTHING OFF] is used to change the histogram display status. When
smoothing is OFF and a histogram key is pressed, raw histogram data are shown.
When [SMOOTHING OFF] is pressed while the status is OFF, the status changes to
ON.
When the status is ON and a histogram key is pressed, normalized and threshold-
edited histogram data are shown. The number of the peak channel is also shown.

9140214 Rev DCJune 1993
When [MORE] is pressed, the fourth of four DIAGNOSTIC MENU screens is

displayed. The following keys may be selected:
[PROBE HOME]
[PROBE UP]
[SAMPLE SYRINGE]/ [RESTORE SYRINGE]
[DILUENT SYRINGE]/ [RESTORE SYRINGE]
[MORE]
[PRINTER OUTPUT]
[HELP]
[MAIN]
These keys are described below.
Probe Home [PROBE HOME] is used to lower the probe to the home position.
Probe Up [PROBE UP] is used to raise the probe to the upper limit.
Sample Syringe/Restore Syringe
[SAMPLE SYRINGE] is used to time the sample syringe dispense cycle.
[RESTORE SYRINGE] is used to time the sample syringe aspirate cycle.
Diluent Syringe/Restore Syringe
[DILUENT SYRINGE] is used to time the diluent syringe dispense cycle.
[RESTORE SYRINGE] is used to time the diluent syringe aspirate cycle.
More [MORE] displays a new screen and keypad labels that allow the operator to perform
additional diagnostics to assist in troubleshooting. This key performs the same
function on all diagnostic menus.
Printer Output [PRINTER OUTPUT] allows the operator to print any screen by turning the printer
output ON before pressing another screen label. This also toggles the printer output
OFF. The current printer status is displayed in the upper left section of the screen.
This key performs the same function on all diagnostic menus.
Help [HELP] steps the operator through one or more Help screens that define the screen
keypad labels and the procedures to be performed. This key performs the same
function on all menus.
Main [MAIN] takes the operator back to the MAIN MENU and performs the same function
on all diagnostic menus.

9140214 Rev DCJune 1993
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 the Abbott Customer Support Center.
Introduction Good troubleshooting skills are learned by using a logical, step-by-step approach to
problem solving. The first step in the process is understanding normal instrument
operation and preventative 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, is not only identifying what is wrong but also noting
what is right. The investigation 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:
! Hardware component related

! Software computer program related
! Measurement related to sample analysis
Typically, hardware and software problems are corrected by an Abbott authorized

service representative. Measurement problems are generally operator correctable. This
category is further subdivided into problems related to sample handling, maintenance
or calibration.
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.

9140214 Rev DCJune 1993
Obtaining Technical Assistance
Technical Assistance is obtained by calling the Abbott Customer Support Center. 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. Examples of sufficient data to facilitate the discussion

9140214 Rev DCJune 1993
Troubleshooting Guide
NOTE Generally, conditions that are instrument- or reagent-related will occur on all samples, including
controls. Therefore, it is important to confirm instrument performance by rerunning controls and/or
additional patient specimens.
Table 10-1. Troubleshooting Guide
Condition Probable Cause Required Action
>>>> Data exceeds Display and For RBC or PLT: Dilute 0.5 mL aliquot of well-mixed whole
appears in place Print capacity. blood with 0.5 mL diluent (1:2 ratio). Close the container and
of result. invert it 10 to 15 times to mix. Run the specimen as usual.
Multiply the RBC, HGB, HCT, and PLT result by 2 to obtain
a reportable value.
For WBC or PLT: Dilute 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 this
specimen as usual. Multiply each WBC and PLT result by 2,
3, 4, or 10 (per ratio of diluent to blood used above) to obtain a
reportable value.
>>>> Wash block and probe Perform the probe removal and replacement procedure
appears in place misaligned. described in Chapter 9, Maintenance. Confirm the probe is
of RBC or PLT properly installed and aligned. Obtain technical assistance.
result.
Abnormal or Dirty HGB flow cell. Perform the hemoglobin flow cell manual cleaning procedure
erratic HGB, as described in Chapter 9, Maintenance.
MCH, and/or
MCHC results. Lipemic sample or Specimen exceeds limitations of the procedure. See Chapter 5,
sample with WBC result Operating Instructions.
above 50,000/FL.
Circuitry malfunction. Go to the diagnostics screen and press [PRINTER OUTPUT].

Press [RAW DATA]. Data display and print. Check the results
for hemoglobin error. As required, obtain technical assistance.

Table 10-1. Troubleshooting Guide (continued)
Background data Interference from other Use dedicated power source or line voltage regulator; relocate
are unacceptable. electrical devices. instrument in an area free from interfering devices.
Cold reagents—less than Allow reagents to warm. Rerun background check. If the
59EF or 15EC. background data are not acceptable, go to the next probable
cause.
Contaminated bath and/or Perform the Auto-Clean procedure described in Chapter 9,

aperture. Maintenance.
Contaminated diluent or Perform the procedures from Chapter 9, Maintenance, to

detergent. prepare the unit for shipping. Use a 1:4 dilution of 5% sodium
hypochlorite to water for cleaning and disinfecting the flow
system. Repeat the procedure using distilled water. Rinse and
refill the flow system with freshly opened containers of diluent
and detergent.
Contaminated lyse. Perform the lyse inlet tube rinse procedure described in
Chapter 9, Maintenance. Install a freshly opened container of
lyse.
Diluent frozen in Replace with a new lot number or different shipment.

shipment.
Malfunctioning circuitry. Obtain technical assistance.

The message Debris, fibrin clots, or Press [CLEAR ORIFICE] to backflush the aperture and reset the
<CLOG> is protein build-up is clog limit. If the situation occurs repeatedly, go to the SPECIAL
displayed in place restricting fluid flow PROTOCOLS MENU and run the Auto-Clean procedure.
of Count Time. through the aperture. Perform manual aperture cleaning. Check the sample for fibrin
clots or red cell agglutination. Redraw the specimen as
required. Rerun the specimen if required.
Flow system blockage Remove the detergent inlet tube from the flow panel normally
resulting from a pinched closed valve. Roll the tube between your fingers to unpinch it.
tube in the diluent or Reinsert the tube in the valve. Repeat this process for the
detergent normally closed diluent tube. If the situation occurs repeatedly, perform the
valve, or reagent particles maintenance procedures to prepare the unit for shipping. Use a
may be in the flow panel. 1:4 ratio of 5% sodium hypochlorite to water.

The message Reagent with different Install only Abbott-recommended reagents as described in
<DETERGENT conductivity was Chapter 2, Installation.
EMPTY> is installed.
displayed. NOTE Stated performance does not apply when other
reagents are installed.
Detergent is not being Exercise the tubing in normally closed valves. (Refer to Tube
pulled into flow system. and Diluent Syringe Installation in Chapter 2, Installation.)
<DILUENT conductivity was Chapter 2, Installation.
Diluent is not being Exercise the tubing in normally closed valves. (Refer to Tube
pulled into flow system. and Diluent Syringe Installation in Chapter 2, Installation.)
With one hand holding steady the calibration block, confirm

Diluent syringe thumb nut that the large knurled thumb nut on the bottom of the syringe is
has vibrated loose. fully tightened—if not, tighten finger tight.
The message Air bubbles are trapped Press [CLEAR ORIFICE] to backflush the aperture and reset the
<FLOW ERR> in the dilution baths. clog limit. Rerun the specimen. If the situation occurs
is displayed in repeatedly, go to the SPECIAL PROTOCOLS MENU and press
place of Count [DRAIN] to drain the liquid from each bath. When the process
Time. is complete, press [REFILL BATHS]. This process removes any
bubbles trapped inside the baths.
Malfunctioning pinch Raise the upper front cover and remove the lower front cover
valve. to gain access to the flow panel. Examine wash flow panel
pinch valves to determine if each valve's press “T” can be
moved—pushed in or pulled out when the valve is closed.
Obtain technical assistance as required.

The message Aperture plates installed Check plate installation. Confirm that the aperture plate
<FLOW ERR> in wrong baths. marked “R/P” is installed in the RBC/PLT bath located to the
or <CLOG> is right of the probe. Confirm that the aperture plate marked
displayed in place “WBC” is installed in the other bath.
of both Count
Times. Insufficient wetting of Remove the upper and lower front covers to gain access to the
(WBC/RBC). detergent reagent to form flow panel. Press the white button (replaces touch plate) below
a good meniscus in the the aspirate probe. Observe fluid flow and meniscus formation
metering tube. in each metering tube. When meniscus formation is poor,
prepare the analyzer for shipping as described in Chapter 9,
Maintenance. Rinse the flow tubes and install a freshly opened
container of detergent. As required, obtain technical assistance.
Remove the upper front cover and open the left panel to gain
Insufficient liquid in the access to the flow panel and syringe panel. Press the touch
bath. Air is drawn plate. Observe the action of the diluent syringe and the fluid
through the aperture. flow in and out of each bath. If the syringe action is not
complete, perform the diluent syringe cleaning procedure
described in Chapter 9, Maintenance. As required, obtain
Check the system for leaks or cracks.

Flow system leak.
Check the aperture under a microscope using a low power
Damaged aperture. objective lens with external light source. If damage is observed,
obtain a replacement aperture plate. Verify calibration after
replacement.
INITIALIZED Power-on initialization The unit is NOT primed. To run specimens, press [RUN].
cycle was performed.

Keypad selection Computer busy Refer to the screen for current status messages; counting, etc.
or entry not performing a function
accepted. that prevents screen label
selection.
None required.
Data being transmitted to
printer or computer.
None required.
Keypad entry not allowed
for this screen.
Turn the power OFF. Wait 30 seconds. Turn the power back
Computer, keypad, and/or ON. If the situation is not corrected, obtain technical
circuitry malfunction. assistance.
<LYSE conductivity was Chapter 2, Installation.
No liquid was detected by Confirm that the end of the lyse tube is immersed in reagent.
the internal lyse sensor. When the container is empty, replace it with a fresh container
of lyse. Press [CLEAR FAULT].
Lyse pump tubing is worn
out. Replace lyse pump tubing if there are signs of deterioration or
if the tubing is over 3 months old.
Lyse inlet tubing is
clogged. Perform lyse inlet tubing flush procedure.
NOTE Never pour the reagent remaining in an old

container into a freshly opened container.

9140214 Rev DCJune 1993
No power. Power cord is loose or not Confirm that the power cord is inserted securely into both the
securely connected to the rear panel connector and wall outlet(s). Confirm that the plug
unit or wall socket. prongs are not bent.
Power switch is OFF.

Move the rear panel power switch to ON.
No voltage or wrong
voltage at the lab power Confirm that the fuse and circuit breaker at facility (site) are
receptacle. acceptable. Confirm that the analyzer's rear panel voltage
selector PCB and fuse are correct for the power provided.
Defective power switch. Obtain technical assistance.
Instrument malfunction. Obtain technical assistance.

No screen The screen brightness Turn the brightness knob clockwise to adjust brightness.
display. adjustment knob is turned
down.
Incoming power Turn power OFF, wait 30 seconds, turn power back ON.
fluctuation.
No screen labels. Cycle in process but not None. Refer to the screen for current status.
complete.
Incomplete data entry. To abandon the unfinished operator entry process and
redisplay the screen labels, press [ENTER].
QC specimen Improper mixing or Refer to Chapter 7, Quality Control, for the proper handling of
results exceed handling of the QC QC specimens.
acceptable limits. specimen.
Dilution error. Rerun specimen. If the situation occurs again, perform the
Auto-Clean procedure and/or the diluent syringe cleaning
procedures described in Chapter 9, Maintenance.
Insufficient or no dilution Remove the upper front cover. Press the touch plate. Observe
mixing. the bubble mix in each bath. As required, obtain technical
assistance.
Run cycle will Defective diskette or Turn the power switch OFF. Replace the system diskette with
not stop. diskette drive. the spare supplied with the analyzer. Obtain technical
assistance.

9140214 Rev DCJune 1993
Specimen will not Fibrin or debris is in the Check the specimen for fibrin clots or red cell agglutination.
aspirate. specimen aspiration Redraw the specimen as required. Check the probe for fibrin
probe. clots, salt deposits, etc. Remove and clean the probe or replace
it.
Vacuum or circuitry Obtain technical assistance.

malfunction.
STANDBY No run cycle was Press [RUN] to run auto-startup, prime the unit, and perform a
activated for 4 hours. The background check.
auto-shutdown cycle was
activated, placing the unit
in standby.
The message Instrument hardware Go to the DIAGNOSTICS MENU screen. A message
<UNINITIAL- malfunction detected pertaining to the computer-detected malfunction is displayed
IZED, SEE during initialization cycle. with the required operator action. As required, obtain technical
DIAGNOS- assistance.
TICS> is
displayed.
The message Liquid level in the waste Remove the waste stopper assembly and empty the container.
<WASTE container has tripped the Press [CLEAR FAULT] to continue. Make sure liquid is wiped
FULL> is sensors. from stopper and top of bottle to ensure good seal.
displayed.
CAUTION Liquid is a possible biological and chemical
hazard. Follow good laboratory safety
practices.
Reinsert the plug into receptacle, then press [CLEAR FAULT]

Waste sensor plug is to continue. Turn power OFF. Wait 10 seconds, then turn
not inserted completely in power ON.
lower left side panel
receptacle. An audible
tone sounds to alert the
operator.
Obtain technical assistance.
Defective component.
Waste full, no Waste sensor plug dirty. Clean plug with alcohol and reinsert fully.
message
displayed. Loose wire in waste cap. Obtain technical assistance.

9140214 Rev DCJune 1993
WBC and/or No lyse reagent added. Remove lyse tube from flow panel normally closed valve and
HGB data are Pinched or cracked lyse roll it between your fingers. If it remains flat, replace the
invalid. tubing. Malfunction of tubing. Insert the tube in the valve. Go to the SPECIAL
lyse pump or pinch valve. PROTOCOLS screen and press [LYSE PRIME]. Observe the
action of the lyse pump (lower left). Confirm that lyse
dispenses into the WBC bath during the prime cycle. As
required, do the lyse tubing rinse procedure described in
Chapter 9, Maintenance, or obtain technical assistance. Verify
lyse volume.
X-B data are out Dirty HGB flow cell. Perform the hemoglobin flow cell manual cleaning procedure
for MCH and/or as described in Chapter 9, Maintenance.
MCHC.
Amount or timing of lyse Perform the lyse inlet rinsing procedure described in Chapter 9,
addition not optimal. Maintenance. Check tubes for cracks and leaks. As required,
obtain technical assistance.
X-B data are out Dirty aperture. Clean aperture plate as described in Chapter 9, Maintenance.
for MCV. As required, obtain technical assistance.

9140214 Rev DCJune 1993
Chapter 11 Printers
Printers
Introduction The CELL-DYN7 1600 is configured with a graphics printer. The printer is set up to
print reports, including complete graphic information, on continuous tractor-feed
paper.
Graphics Printer This section gives a brief overview of Graphics Printer maintenance and
troubleshooting. Instructions for installation are given in the Printer Installation
section of Chapter 2, Installation. For a detailed description of the printer
components and instructions on changing the ribbon and loading paper, refer to the
manuals that accompany the printer.
The CELL-DYN 1600 software automatically controls and adjusts most print
conditions. Occasionally, a few settings may need to be changed in the printer
software for correct operation. 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 the Abbott Customer Support Center for assistance.
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 Customer Support
Center for assistance.
NOTE If, during routine system operation, the message <PRINTER UNAVAILABLE>
is displayed, check to see that the printer cable is securely connected to the data
module, the printer power switch is turned ON, and that the Select indicator is
illuminated. Press [PRINT] . If the message is still displayed, turn the printer power
OFF, wait about 5 seconds, turn the power ON again and press [PRINT] . If the
message is still displayed, there may be an internal printer error. Contact the Abbott
Customer Support Center for assistance.
Ticket Printer If ticket printing is desired for the CELL-DYN 1600, a second printer (known as the
Ticket Printer) can be connected to the system at the same time as the graphics
printer. Instructions for the installation of both printers are given in the Printer
Installation section of Chapter 2, Installation. Complete directions for customizing
the printout type and format are given in the Setup System Operation section of
Chapter 2, Installation.
For detailed information about loading paper and changing the ribbon in the ticket
printer, refer to the manuals that accompany the printer. In particular, note the
important safety instructions.
CELL-DYN7 1600 Operator's Manual 11-1

9140214 Rev DCJune 1993
Printers Chapter 11
Printing Tickets To print tickets, the printer cable must be connected to the ticket printer connector on
the right side of the data module. (See Figure 2-1 for the location of these
connectors.) Refer to the Customize Printout section in the Setup System Operation
section of Chapter 2, Installation, for instructions for customizing either type of
printout.
Maintenance Every 6 months (or after about 300 hours of operation), 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. Be sure to turn the
printer OFF before cleaning.
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 Customer Support
Center for assistance.
NOTE If, during routine system operation, the message <PRINTER UNAVAILABLE>
is displayed on the bulletin line, check to see that the printer cable is securely
connected to the data module, the printer power switch is turned ON, and that the
Select indicator is illuminated. Press [PRINT] . If the message is still displayed, turn
the printer power OFF, wait about 5 seconds, turn the power ON again and press
[PRINT] . If the message is still displayed, there may be an internal printer error.
Contact the Abbott Customer Support Center for assistance.
11-2 CELL-DYN7 1600 Operator's Manual

9140214 Rev DCJune 1993
Chapter 12 CELL-DYN® 1600CS
CELL-DYN 1600CS
Closed Sample Aspiration Module
NOTE This addendum describes the installation, operation, and maintenance of the CELL-
DYN 1600CS Closed Sample Aspiration Module. To install and operate this
module, the CELL-DYN 1600 must be fully operational. Refer to the following
chapters for more information on the installation, setup, and operation of the CELL-
DYN 1600.
! Installation and setup Chapter 2

! Operating instructions Chapter 5
Introduction The CELL-DYN 1600CS is a multi-parameter, automated hematology analyzer

designed for in vitro use in clinical laboratories. It is, in essence, the
CELL-DYN 1600 with the added capability to aspirate specimens from a closed
collection tube.
The Closed Sample Aspiration Module is a factory-installed option for the CELL-
DYN 1600. It is activated by a touch plate below the module's safety door.
When the touch plate is activated, a specimen is aspirated from a closed collection
tube and pumped to the sample container in the closed sampler module. The
specimen probe then aspirates the proper volume from the sample container and
performs the WBC and RBC/PLT measurements described in the other chapters of
this manual.
WARNING Consider all clinical specimens and controls, calibrators, etc. that contain human
blood or serum as potentially infectious. Use established, good laboratory working
practices when handling these samples. Wear gloves, lab coats and safety glasses and
follow other biosafety practices as specified in the OSHA Bloodborne Pathogen Rule
or other equivalent biosafety procedures.
CAUTION Wear powder-free gloves when performing the maintenance procedures. If powder-
free gloves are not available, rinse the gloves before performing the maintenance
procedures. Powder from the gloves may cause instrument problems.
System Components
The closed sample aspiration module is mounted on a door that is hinged at the left
and attached to the CELL-DYN 1600 by a thumbscrew on the right side of the
module.

CELL-DYN® 1600CS Chapter 12
The front panel of the module includes the following components:
Figure 12-1 Closed Sampler
! A tube holder (2) for the closed collection tube. The holder contains a needle
to pierce the collection tube stopper.
! An adjustable tube guide (3) to correctly position the tube in the holder.
! A movable safety door (1) with a safety interlock that prevents cycle
activation via the touch plate unless the door is closed.
! The touch plate (4) activates the closed sample aspiration cycle. The touch
plate is not operational when the safety door is open.
! The thumbscrew (5) attaches the closed sampler module to the front panel.
When loosened, the module swings open to allow access to the module's
internal flow panel.
Flow Panel The closed sampler Internal Flow Panel is located on the inside of the module door.
To access the flow panel, unscrew the thumbscrew located on the right side of the
module and swing the door out toward you.
Figure 12-2 Internal Flow Panel

The closed sample aspiration module internal flow panel includes the following
components:
! Two peristaltic pumps located near the bottom of the module door. Next to
each pump is a pump tube holder and two tube stops. The tube stops are
designed to prevent the tube from moving during pump rotor action.
! Four normally closed valves above the two peristaltic pumps.
! A sample container into which the specimen is pumped after it is aspirated
from the closed collection tube.
Closed Sample Aspiration Module Installation

Refer to Chapter 2, Installation, for CELL-DYN 1600 installation procedures. The
instrument must be operational before the closed sample aspiration module can
function properly. The closed sample aspiration module is shipped with the internal
flow panel peristaltic pump tubes and normally closed valve tubes removed.
1. Turn the thumbscrew on the right side of the module counterclockwise until
the door swings open.
2. Pull the module door toward you.
3. Locate the peristaltic pumps, the pump tube holders, and the tube stops
located above and below each pump rotor.
4. Insert the ends of the pump tube into the two tube stops.
5. Push the upper end of the tube holder away from the pump rotor.
6. While holding the tube holder away from the rotor, insert the pump tube
between the pump rotor and the tube holder.
CAUTION Make sure the tubing is not crimped or pinched.
7. Repeat steps 1-6 to place the second pump tube under the second rotor.
8. Locate the normally closed valve and the valve tube. Carefully stretch the
tube and insert it into the valve opening. Work the tube back and forth gently
until it is completely seated in the valve.
CAUTION Make sure the tubing is not crimped or pinched.

Tube Guide Adjustment Procedure

The tube guide of the closed sampler module is factory set to accept 75 mm high
Vacutainer® tubes. As required, the tube guide can be adjusted to accept Vacutainer
tubes that are 100 mm high. An Allen wrench is included in the accessory kit for use
in making this adjustment.
1. Locate and remove the Allen wrench provided in the accessory kit.
2. Move the tube guide to the left to gain access to the lower guide clamp and
nut.
Figure 12-3 Tube Guide
3. Insert the Allen wrench into the lower clamp nut and turn the wrench
counterclockwise to loosen it. (The clamp slides freely on the rod.)
4. Insert the Allen wrench into the upper clamp nut and loosen it.
5. Insert the new size Vacutainer® tube into the holder.
6. Slide the clamp down or up as required until it is properly positioned to hold

the tube.
7. Press down lightly on the guide to provide a slight tension on the spring.
8. Tighten the upper clamp nut while holding the guide down.
9. Remove the Vacutainer tube and tighten the lower clamp nut.

10. Insert and remove the new size Vacutainer tube from five to ten times to confirm
that both clamp nuts are tight.
Overview of the Run Mode

Only specimens collected in a standard Vacutainer tube, either 75 mm or
100 mm high, and containing EDTA anticoagulant can be run via the closed sample
aspiration module. The specimens should be no more than four hours old to provide the
most accurate results for all parameters.
<CLS> appears on line 3 of the upper left RUN MENU. <C> appears after the Sequence
# in the data log and QC files to designate that the specimen was run via the closed
sampler. The CELL-DYN 1600CS is ready to run samples in the closed sample
aspiration module after the power-on initialization and startup cycles.
Run Procedure Follow the same preparation steps to run the closed sample as you would to run an open
sample. Refer to Chapter 5, Operating Instructions, for instructions.
1. Pull the closed sample aspiration module safety door forward.
2. Invert the well-mixed specimen and place it in the tube holder. Confirm that the
bottom of the tube is securely seated in the tube clamp.
3. Close the safety door.
4. Press the closed sampler touch plate.
5. Review the results on the RUN screen.
6. Repeat steps 1 through 5 for any additional samples to be run.
CAUTION If the system has been idle for 15 minutes or more, a normal background should be run
immediately prior to running any patient specimens.
Verification and Calibration

No significant difference between specimens run by the open aspiration mode and the
closed aspiration mode was observed during clinical evaluations. However, mode to
mode verification should be done any time calibration of the system is performed.

12-5
9140214 Rev F—April 1996
Closed Mode Calibration Verification

1. Confirm that the system has been properly calibrated in the open mode as
outlined in Chapter 6, Calibration.
2. Obtain a normal fresh whole blood sample. A full 7 mL tube is required. In an

empty replicate file, run the sample five times in the open mode and five times in
the closed mode.
3. The C.V. values for each parameter must meet the following criteria:
WBC ≤ 2.5%
RBC ≤ 1.7%
HGB ≤ 1.2%
MCV ≤ 1.5%
PLT ≤ 6.0%
Refer to System Specifications, Chapter 4, for acceptable ranges.
4. If all parameters are within these limits, document in your laboratory's

instrument log book that closed mode calibration verification has been
performed. No further action is required.
5. If one or more parameters do not meet this criteria, repeat the procedure using a
different whole blood sample.
6. If the results from the second sample fail to meet the above criteria for any
parameter, contact the Abbott Customer Support Center for assistance.
Calibration Refer to Chapter 6, Calibration, regarding recommended guidelines for calibration

frequency.
Materials Required
• A minimum of five different fresh whole blood samples. All parameter values
should be within the laboratory's normal range. Refer to sample requirements for
fresh whole blood, Chapter 6, Calibration. Each sample must have sufficient
volume to be run three times in both the open and closed mode. Therefore, it is
advisable to select full 5 mL tubes.
• Calculator
• Mode to Mode Verification & Calibration Worksheet
12-6
9140214 Rev F—April 1996
Procedure 1. Confirm that the background counts are acceptable and precision is within
established limits (see Chapter 4, System Specifications).
2. Confirm calibration of the open mode by running all three levels of

commercial controls. Refer to the calibration procedure in the operator's
manual if open mode calibration is required.
3. Select two replicate files to be used for the determination of the mean value
for each mode. Purge any existing data in each file.
4. Determine the Open Mode Mean as follows:
A. From the RUN MENU, press [SPECIMEN TYPE] and the number of
the first file.
B. Run each well-mixed sample two times into the file in the open mode.
C. Go to the QC MENU and choose the same file.
D. Press [PRINT DATA].
5. Determine the Closed Mode Mean as follows:
A. From the RUN MENU, press [SPECIMEN TYPE] and the number of
the second file.
B. Run each well-mixed sample (the same samples as in Step 4) two times
into the file in the closed mode.
C. Go to the QC MENU and choose the same file.
D. Press [PRINT DATA].
6. Use worksheet section #1 to calculate the Mode to Mode Calibration Bias.
7. Enter the percent Bias for each parameter in worksheet section #2. If all
parameters are within the validation range, document in your laboratory's
instrument log book that verification has been completed. Calibration is not
necessary and no further action is required. If any parameters require
calibration, continue with the next section.
Closed Mode Calibration

1. From the RUN MENU, press [MAIN].

3. Enter the digits: 9 4 0 4 3.
4. Press [PRINT] to obtain a printout of the current Whole Blood Dilution

Factors for the Open Sample and Closed Sample. The Dilution Factors are
provided to adjust for mode to mode variation.
5. Record the Closed Sample Dilution Factors on worksheet section #3.
6. Record the Open Mode means and the Closed Mode means (Step 4) on
worksheet section #3.
7. Use worksheet section #3 to calculate factors for the parameters that require
calibration. Enter the new Closed Sample Dilution Factors.
8. Confirm Closed Mode Calibration as follows:
A. Purge the replicate file in which you ran the closed mode samples.
B. Re-run the same five well-mixed samples at least once each into this file
in the closed mode.
C. Go to QC and choose this file.
D. Print data.
E. Using worksheet section #4, calculate the percent Bias.
F. If the calibration bias exceeds these established limits, verify that all
calculations were correct and that the new factors were entered correctly.
If no errors are detected, call the Abbott Customer Support Center for
assistance.
Quality Control
Complete instructions for Quality Control are given in chapter 7.
The following procedure may be used to verify the performance of the Closed
Sampler mode of operation.

Mode to Mode QC Verification
Good laboratory practice mandates that controls be run in all modes in which samples
will be run. CELL-DYN control materials may be run in the Open or Closed mode on
those CELL-DYN Systems with two modes of operation. Patient samples can be
assayed in the Open mode after verifying that CELL-DYN controls fall within the
laboratory's acceptable limits. These samples may then be used to verify the operation of
the Closed mode. The following is a suggested procedure for using patient samples to
verify the operation of the Closed mode.
Procedure 1. Run a minimum of two levels of control in the Open mode at the beginning of
each eight hours of operation prior to running patient samples. Control samples
must be run in the same manner as patient samples.
2. When control results are within the laboratory's acceptable limits, record the
results and process patient samples in the Open mode.
3. Select three normal patient samples from the Open mode run. Sample results
should fall within the laboratory's normal range.
NOTE Two samples may be used but three are preferred.
4. Select and configure three replicate files, one for each sample, for Mode to Mode
verification.
NOTE Replicate files store only the absolute values for the three-part differential. If you wish
to validate the differential percents (%LYM, %MID, %GRAN), you must manually
record the values directly from the RUN SCREEN or from the printout of each control
run. The differential percentage data taken from the individual control runs must be used
to manually calculate the mean differential percentages.
5. Run the first selected patient sample in the Open mode in the replicate file
configured for sample 1. Run the second and third samples in the Open mode in
their respective files.
6. Run the first normal patient sample in the Closed mode in the replicate file
configured for sample 1. Run the second and third samples in the Closed mode
in their respective files.

12-9
9140214 Rev F—April 1996
7. Verify that the Closed mode results match the Open mode results within the
laboratory's acceptable limits. The following ranges are provided as a guideline.
WBC ± 0.4 LYM ± 0.3

RBC ± 0.12 MID ± 0.2
HGB ± 0.3 GRAN ± 0.3
MCV ± 2.0 %LYM ± 3.0
PLT ± 20 %MID ± 2.0
MPV ± 1.4 %GRAN ± 5.0
8. Results from at least two of the three samples must fall within the established
range for all parameters. When the results are within the established range,
record the difference between the Open and Closed mode results on the logsheet
provided and process patient samples in the Closed mode.
NOTE A Mode to Mode QC Verification logsheet is provided at the end of this section for
recording the differences. This logsheet may be duplicated as needed.
9. If results are outside the established range, contact the Customer Support Center
for assistance.
Maintenance Complete maintenance instructions are given in Chapter 9. In addition to the Open
Mode maintenance, the following Closed Sampler maintenance should be performed
weekly:
1. Perform the Closed Sampler Auto-Clean procedure as directed in Chapter 9.
2. Clean the Closed Sampler Holder as directed in the procedure given in Chapter
9.
3. Check the peristaltic pump tubing and replace as needed.
12-10
9140214 Rev F—April 1996
Mode to Mode Verification & Calibration Worksheet
Date: ________________________________
Name: _______________________________
Calculate all calibration factors to three decimal places
Mode to Mode Calibration Bias
% Bias = Closed Mode Mean - Open Mode MeanX 100

Open Mode Mean
#1
Closed Mode Mean - Open Mode Mean ÷ Open Mode Mean X 100 = % Bias
WBC - ÷ X 100 =
RBC - ÷ X 100 =
HGB - ÷ X 100 =
MCV - ÷ X 100 =
PLT - ÷ X 100 =
Mode to Mode Calibration Criteria

#2
Validation Range Calibration Range Calibration Limit Cal?

% Cal Not Required Cal Needed Do Not Cal* Y or N
Bias
WBC ≤ ± 2.00% > ± 2.00% But ≤ ± 10% > ± 10%
RBC ≤ ± 1.25% > ± 1.25% But ≤ ± 10% > ± 10%
HGB ≤ ± 1.25% > ± 1.25% But ≤ ± 10% > ± 10%
MCV ≤ ± 1.25% > ± 1.25% But ≤ ± 10% > ± 10%
PLT ≤ ± 3.50% > ± 3.50% But ≤ ± 20% > ± 20%
* Do not calibrate. Call the Abbott Customer Support Center for assistance
.

12-11
9140214 Rev F—April 1996
Mode to Mode Verification & Calibration Worksheet
Date: ________________________________
Name: _______________________________
Calculate all calibration factors to three decimal places
New Closed Sample Dilution Factors
Open Mode Mean X Current Closed Factor* = New Closed

Closed Mode Mean Sample Dilution Factor
#3
Open Mode Closed Mode Closed Sample New Closed Sample
Mean ÷ Mean x Dilution Factor* = Dilution Factor Range**
WBC ÷ x = 0.700 - 1.300
RBC ÷ x = 0.800 - 1.200
HGB ÷ x = 0.700 - 1.300
MCV ÷ x = 0.700 - 1.300
PLT ÷ x = 0.700 - 1.300
* Current factor printed in Step 4.

** If factor exceeds limits, Do Not Calibrate. Check all calculations and call Technical Service
for assistance.
Mode to Mode Post-Calibration Bias
% Bias = Closed Mode Mean - Open Mode Mean X 100

Open Mode Mean
#4
Closed Mode Open Mode Open Mode

Mean* - Mean ÷ Mean X 100 = % Bias Range**
WBC - ÷ X 100 = # ± 2.00%
RBC - ÷ X 100 = # ± 1.25%
HGB - ÷ X 100 = # ± 1.25%
MCV - ÷ X 100 = # ± 1.25%
PLT - ÷ X 100 = # ± 3.50%
* Mean after calibration.

** If % Bias exceeds limits, call the Abbott Customer Support Center for assistance.

CELL-DYN 1600 Mode to Mode QC Verification
Daily Differences Logsheet
Month:____________ Instrument:_____________
DATE SAMPLE ID NO. WBC RBC HGB MCV PLT MPV LYM MID GRAN %LY %MID %GRAN TECH
S1:
S2:
S3:
S1:
S2:
S3:
S1:
S2:
S3:
S1:
S2:
S3:
S1:
S2:
S3:
S1:
S2:
S3:
S1:
S2:
S3:
AVG. DIFFERENCE
12-13

Tables
Table T-1: Potential Causes of Erroneous Results with Automated Cell Counters
PARAMETER CAUSES OF SPURIOUS INCREASE CAUSES OF SPURIOUS DECREASE
W HITE CELL COUNT (WBC) Cryoglobulin, cryofibrinogen Clotting
Heparin Smudge cells
Monoclonal proteins Uremia plus immunosuppressants
Nucleated red cells
Platelets clumping
Unlysed red cells
RED CELL COUNT (RBC) Cryoglobulin, cryofibrinogen Cold agglutinins
Giant platelets Clotted specimen (microclot)
Elevated white cell count Hemolysis (in vitro)
(> 50,000/µL) Polycythemia (increased RBC
coincidence)
Microcytic red cells
HEMOGLOBIN (HGB) Carboxyhemoglobin (> 10%) Clotted specimen (microclot)
Cryoglobulin, cryofibrinogen
Hemolysis (in vivo)
Elevated white cell count
Hyperbilirubinemia, severe
Lipemia
Abnormal plasma proteins
HEMATOCRIT (PACKED CELL Cryoglobulin, cryofibrinogen Autoagglutination
VOLUME - ANALYZER METHOD) Giant platelets Clotted specimen (microclot)
Elevated white cell count Specimen hemolysis
Hyperglycemia (> 600 mg/dL)
HEMATOCRIT (PACKED CELL Hyponatremia Excess EDTA
VOLUME - MANUAL METHOD) Plasma trapping Hemolysis (in vitro)
Hypernatremia
MEAN CELL VOLUME Autoagglutination Cryoglobulin, cryofibrinogen
High white cell count (> 50,000/µL) Giant platelets
Hyperglycemia Hemolysis (in vitro)
Reduced red cell deformability Microcytic red cells
Swollen red cells
MEAN CELL HEMOGLOBIN High white cell count Spuriously low hemoglobin
(> 50,000/µL) Spuriously high red cell count
Spuriously high hemoglobin
Spuriously low red cell count
MEAN CELL HEMOGLOBIN Autoagglutination High white cell count
CONCENTRATION Clotting (> 50,000/uL)
Hemolysis (in vivo and in vitro) Spuriously low hemoglobin
Spuriously high hemoglobin Spuriously high red cell count
Spuriously low hematocrit
PLATELETS (PLT) Cryoglobulin, cryofibrinogen Clotting
Hemolysis (in vivo and in vitro) Giant platelets
Microcytic red cells Heparin
Red cell inclusions Platelet clumping
White cell fragments Platelet satellitosis
CELL-DYN® 1600 Operator's Manual Tables-1

9140214 Rev D — June 1993
Tables
Table T-2: Normal Values for Automated Blood Counters

PARAMETER ADULT MALE ADULT FEMALE CHILDREN CHILDREN CHILDREN
>18 YEARS >18 YEARS AT 1 MONTH AT 2 YEARS AT 10 YEARS
WBC (K/µL) 4.6 - 10.2 4.6 - 10.2 5.0 - 20.0 6.0 - 17.0 5.0 - 13.0
LYMPHOCYTES 0.6 - 3.4 0.6 - 3.4 6.0mv 6.3mv 3.1mv

(K/µL)
LYMPHOCYTES (%) 10 - 50 10 - 50 55mv 60mv 40mv
MONOCYTES (K/µL) 0 - 0.9 0 - 0.9
MONOCYTES (%) 0 - 12 0 - 12 6mv 5mv 4mv
EOSINOPHILS (K/µL) 0 - 0.7 0 - 0.7
EOSINOPHILS (%) 0-7 0-7 3mv 2mv 2mv
BASOPHILS (K/µL) 0 - 0.2 0 - 0.2
BASOPHILS (%) 0 - 2.5 0 - 2.5 0.5mv 0.5mv 0.5mv
NEUTROPHILS 2.0 - 6.9 2.0 - 6.9 3.8mv 3.5mv 4.4mv

(K/µL)
NEUTROPHILS (%) 37 - 80 37 - 80 30mv 30mv 50mv
RBC (M/µL) 4.69 - 6.13 4.04 - 5.48 3.9 - 5.9 3.8 - 5.4 3.8 - 5.4
HEMOGLOBIN (g/dL) 14.1 - 18.1 12.2 - 16.2 15 - 18 11 - 13 12 - 15
HEMATOCRIT (%) 43.5 - 53.7 37.7 - 47.9 44mv 37mv 39mv
MCV (fL) 80 - 97 80 - 97 91mv 78mv 80mv
MCH (pg) 27.0 - 31.2 27.0 - 31.2 33mv 27mv 25mv
MCHC (g/dL) 31.8 - 35.4 31.8 - 35.4 35mv 33mv 34mv
PLATELETS (K/µL) 142 - 424 142 - 424 277mv 300mv 250mv
RDW (%) 11.6 - 14.8 11.6 - 14.8
NOTES Source: Theml, H. Pocket Atlas of Hematology and Bessman, J. D. Automated Blood Counts and Differential
mv
denotes mean value
For adult black males and females, normal WBC is 2.9 K/µL - 7.7 K/µL
For adult black males and females, normal RBC, HGB and HCT is 5% less
For children age 6 months to 18 years, mean MCV value is approximately 75 + (0.8 x age in years)
For newborns, MCV is 88 - 114 and RDW is 14.9 - 18.7
Tables-2 CELL-DYN® 1600 Operator's Manual

9140214 Rev D — June 1993
Tables
Table T-3: Anemia Classification Based on MCV and RDW

MCV (LOW) MCV (NORMAL) MCV (HIGH)
RDW Non-anemic heterozygous Normal Aplastic anemia

(NORMAL) thalassemia Chronic disease Hyperglycemia
Chronic disease Non-anemic hemoglobin Chronic liver disease
Children abnormalities Chronic myelogenous
Non-anemic enzyme leukemia
abnormalities Cytotoxic chemotherapy
Chronic lymphocytic leukemia
Splenectomy
Acute blood loss
Chronic liver disease
Chronic myelogenous
leukemia
Cytotoxic chemotherapy
RDW Iron Deficiency Early or mixed nutritional Folate or vitamin B12

(HIGH) Hgb S-Alpha or Beta deficiency deficiency
Thalassemia Anemic hemoglobin Sickle cell anemia
Hgb H abnormalities (1/3 of cases)
Myelofibrosis Immune hemolytic
Sideroblastic anemia
Myelodysplasia Cold agglutinins
Chronic liver disease Preleukemia
Chronic myelogenous Newborn
leukemia Chronic liver disease
Cytotoxic chemotherapy Chronic myelogenous
leukemia
Cytotoxic chemotherapy
Table T-4: Progressive Stages of Iron Deficiency

*
STAGE IRON STORES RDW MCV HGB
DEPLETION Reduced Normal Normal Normal
HETEROGENEOUS Reduced High Normal Normal
MICROCYTIC Reduced High Low Normal
ANEMIC Reduced High Low Low
* Marrow stainable iron; ferritin; or transferrin saturation
CELL-DYN® 1600 Operator's Manual Tables-3

9140214 Rev D — June 1993
Tables
Table T-5: Morphophysiologic Classification of Red Cell Disorders

ANEMIA MCV (LOW) MCV (NORMAL) MCV (HIGH)
HYPOPROLIFERATIVE DISORDERS:
RDW Chronic disease Chronic disease Aplastic anemia
(NORMAL)
NUTRITIONAL DISORDERS:
RDW Iron deficiency Early iron, folate, or Folate, or vitamin B12
(HIGH) Sideroblastic vitamin B12 deficiency deficiency
Sideroblastic Sideroblastic
HEMOLYTIC DISORDERS: RDW is increased proportionally to degree of anemia.
RDW Thalassemia trait AS, AC, non-anemic Chronic non-anemic
(NORMAL) or carrier hemoglobinopathies enzyme or membrane
defects
RDW Thalassemia itermedia Hgb SS Hgb SS
(HIGH) or H disease
S-beta thalassemia
SS and alpha
thalassemia
ARTIFACTS: Histogram abnormal
RDW Red cell fragments Red cell fragments Cold agglutinins
(HIGH) post-transfusion Hyperglycemia
Chronic lymphocytic
leukemia
Source: Adapted from Bessman, Gilmer, and Gardner 1983
Table T-6: Result Abnormalities Caused by Artifacts

ITEM RBC HGB HCT MCV MCH MCHC HISTOGRAM ARTIFACT
LOCATION
RED CELL FRAGMENTS ↓ ↑ ↓ ↓ ↑ ↑ < 80 fL
LYMPHOCYTE ↑ N ↑ ↑ ↓ ↓ >180 fL
RED CELL AGGLUTINATION ↓ N ↓ ↑ ↑ ↑ 150 - 170 fL
HYPERGLYCEMIA N N ↑ ↑ N ↓ -----
FREE PLASMA HEMOGLOBIN N ↑ N N ↑ ↑ -----
↓ = Decreased; ↑ = Increased; N = Normal
Tables-4 CELL-DYN® 1600 Operator's Manual

9140214 Rev D — June 1993

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ABBOTT LABORATORIES ENTIRE CONTENTS COPYRIGHT

2. Installation Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

CELL-DYN® 1600 Operator's Manual Table of ContentsC1

PLT Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

6. Calibration Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

Table of ContentsC2 CELL-DYN® 1600 Operator's Manual

Quality Control Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4

8. Precautions, Limitations and Hazards

9. Maintenance Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1

CELL-DYN® 1600 Operator's Manual Table of ContentsC3

Accumulator Draining and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-27

11. Printers Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1

12. CELL-DYN 1600CS Closed Sample Aspiration Module Addendum

Table of ContentsC4 CELL-DYN® 1600 Operator's Manual

Figures Figure 1-1 Front Panel View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

Tables Table 2-1 Power Source Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

CELL-DYN® 1600 Operator's Manual Table of ContentsC5

Table of ContentsC6 CELL-DYN® 1600 Operator's Manual

Foreword Congratulations on becoming a proud operator of the CELL-DYN® System. Using

The CELL-DYN System is backed by dedicated professionals who excel in

If a problem should arise that cannot be resolved by telephone, on-site support is

Abbott Laboratories is dedicated to manufacturing the highest quality, most reliable

The CELL-DYN instrument system is covered by the following U.S. patent:

All operating instructions must be followed. In no event shall Abbott be responsible

CELL-DYN® 1600 Operator's Manual i

Abbott Instrument Warranty

Abbott's Warranty coverage limits are as follows:

1. 24 hour-7 day/week phone support from our Customer Support Center.

2. 8:30 a.m.-5:00 p.m. (Monday-Friday, excluding all Abbott-observed

This warranty does not cover defects or malfunctions which:

2. Result from chemical decomposition or corrosion.

3. Are caused by customer or third party abuse, misuse or negligence, or by

4. Result from maintenance, repair or modification performed without Abbott's

ii CELL-DYN® 1600 Operator's Manual

The CELL-DYN® 1600 Series Hematology Systems are manufactured by Abbott

CELL-DYN® 1600 Operator's Manual iii

Abbott Customer Support Center

1-800 CELLDYN (235-5396)

iv CELL-DYN® 1600 Operator's Manual

Conventions Used in This Manual

INFORMATION HOW PRESENTED

Menu name Helvetica equivalent, CAPITAL letters

Key names below screen Helvetica bold equivalent, enclosed in []

Numeric and special Times Roman equivalent, Initial

Status Helvetica equivalent, CAPITAL letters

Message Helvetica bold equivalent,

CELL-DYN® 1600 Operator's Manual v

vi CELL-DYN® 1600 Operator's Manual

Revision Number Pages Revised and Added

Originally Issued B 9211352A B 12/88 Not applicable.

9211352B B 4/89 Added Addendum for CELL-DYN 1600CS.

9211352C B 12/92 Added cross-reference Part Number list and name

92352-01C B 2/93 Changed Part Number 9211352 to Abbott List

92352-01E - 12/94 Introduction: updated telephone numbers, patents,

92352-01F - 4/96 The following pages have changed (Part No.

©1993, 1994, and 1996 Abbott Laboratories, Abbott Park, IL 60064.

CELL-DYN® 1600 Operator's Manual vii

viii CELL-DYN® 1600 Operator's Manual

Reference List of Trademarks

Teflon is a registered trademark of E. I. duPont de Nemours.