Cell-Dyn 1600 Operator's Manual: 9140214 Rev H-May 2004

Table of Contents
Introduction Foreword. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
Proprietary Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
Pictorial Disclaimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
Abbott Instrument Warranty. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Abbott Diagnostics Division Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv
Conventions Used in This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v
Revision Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii
Reference List of Trademarks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix
Parts 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
X-B File Setup Key. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21
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
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9140214 Rev H—May 2004
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-11
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
CELL-DYN 1600 Pre-Calibration Procedures Check List . . . . . . . . . . . . . . . . . . . .6-9
Auto-Cal Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-11
Factor Entry Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-13
Pre-Dilute Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-15
Lyse Volume Dispense Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-18
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7. Quality Control Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Quality Control Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
X-B File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
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
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

9140214 Rev H—May 2004
‘T’ Fitting Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-26
Vent Line Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-27
Accumulator Draining and Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-28
Preparing the Analyzer for a Prolonged Period of Non-Use or for Shipping . .9-29
Aspiration Probe Removal and Replacement . . . . . . . . . . . . . . . . . . . . . . . . . .9-30
PREVENTIVE MAINTENANCE LOG FOR CELL-DYN 1600 . . . . . . . . . .9-32
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

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 Daily Differences 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: Morphophysiologic Classification of Red Cell Disorders . . . . . . . . T-4
Table T-6: Result Abnormalities Caused by Artifacts . . . . . . . . . . . . . . . . . . . . T-4

9140214 Rev H—May 2004
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16
Figure 6-2 Vial Closure for Mixing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17
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 25ºC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Table 10-1 Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-7

9140214 Rev H—May 2004
9140214 Rev H—May 2004
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 engineer-
ing, 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, 1998 and 2004 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 following U.S. patents are relevant to the CELL-DYN 1600 Instrument or its
components. There are other such patents and patent applications in the United States
and worldwide. 4,745,071 and 5,227,304.
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.
Pictorial Disclaimer
All samples (printouts, graphics, displays or screens, etc.) are for information and
illustration purposes only and shall not be used for clinical or maintenance
evaluations.
CELL-DYN® 1600 Operator’s Manual i

9140214 Rev H—May 2004
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 Abbott Diagnostics
Customer Service 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 Abbott Diagnostics Customer Service.
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

9140214 Rev H—May 2004
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 Division, 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 Abbott Diagnostics Customer
Service. (U.S. customers only.) International customers should contact the local
Hematology Customer Support representative.
CELL-DYN® 1600 Operator’s Manual iii

9140214 Rev H—May 2004
Abbott Diagnostics Division
Customer Service
200 Abbott Park Road
Abbott Park, IL 60064, USA
1-877-4ABBOTT
(1-877-422-2688)
iv CELL-DYN® 1600 Operator’s Manual

9140214 Rev H—May 2004
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

9140214 Rev E—February 1994
vi CELL-DYN® 1600 Operator’s Manual
Revision Status
The Revision status of the manual is indicated below. Be sure that your manual contains the latest revision letter for
each page.
Document Control
Revision Date Section(s) Revised Pages Revised and Added
Number(s)
New Release December/1988 N/A N/A
9211352A
9211352B April/1989 Addendum Added Addendum for
CELL-DYN 1600CS
9211352C December/1992 Added cross-reference Part
Number list and name
change from Unipath to
Abbott Laboratories.
92352-01C February/1993 Changed Part Number
9211352 to Abbott List
Number 92352-01.
92352-01D June/1993 All All
92352-01E December/1994 Introduction pp. i, iv, ix, x, xii
1: System Description p. 1-10
3: Principles of Operation p. 3-15
4: System Specifications p. 4-3
7: Quality Control pp. 7-5 and 7-6
12: Closed Sampler p. 12-8
Module
92352-01F April/1996 Introduction pp. vii and viii
1: System Description pp. 1-9 and 1-10
5: Operating Instructions pp. 5-7 through 5-10
6: Calibration pp. 6-7 and 6-8
7: Quality Control pp. 7-5 and 7-6, 7-9, and
7-10
8: Precautions, pp. 8-1 and 8-2
Limitations and Hazards
9: Maintenance pp. 9-7 through 9-10; 9-31
and 9-32
10: Troubleshooting pp. 10-7 through 10-10
12: Closed Sampler pp. 12-5; 12-6; 12-9 through
Module 12-12
CELL-DYN® 1600 Operator’s Manual vii

9140214 Rev H—May 2004
Document Control
Revision Date Section(s) Revised Pages Revised and Added
Number(s)
92352-01G November/1998 Cover Replaced List No./Cover
page
Foreword pp. i; iii; vii and viii
9: Service and pp. 9-24; 9-25
Maintenance
10: Troubleshooting and p. 10-7
Diagnostics
92352-01H May/2004 Table of Contents All
Foreword pp. i through iv; vii through xii
2: Installation p. 2-4
4: System Specifications pp. 4-3 through 4-6
5: Operating Instructions pp. 5-4; 5-8 through 5-13
6: Calibration pp. 6-1 through 6-3; 6-8
through 6-20
7: Quality Control pp. 7-5; 7-7 and 7-8; 7-11
9: Maintenance pp. 9-3; 9-5; 9-10; 9-14; 9-24
through 9-34
10: Troubleshooting pp. 10-5 through 10-7
11: Printer pp. 11-1 and 11-2
12: Closed Sample pp. 12-6; 12-8; 12-10; 12-11;
Module 12-12
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

9140214 Rev H—May 2004
Reference List of Trademarks
The following trademarks are referred to throughout this manual:
CELL-DYN is a registered trademark of Abbott Laboratories.
Teflon, Vacutainer, and Westgard are not trademarks of Abbott Laboratories.
Symbols
The CELL-DYN reagents that are used on the CELL-DYN 1600 instrument have
been CE Marked to the European IVD Directive. As a part of the CE Marking process,
symbols are added to the product’s labeling. The symbols listed below are included on
the CELL-DYN reagent labels.
Symbol Definition
Legal Manufacturer
EC REP Authorized Representative
IVD For In Vitro Diagnostic Use
REF List Number
LOT Lot Number
Use By/Expiration Date
Consult instructions for use
DILUENT Diluent Reagent
DETERGENT Detergent Reagent
LYTIC AGENT Lytic Agent
CELL-DYN® 1600 Operator’s Manual ix

9140214 Rev H—May 2004
Parts List
List numbers are unique identifiers used when ordering products. List Numbers and quantities provided in this
operator’s manual are intended for guidance only and are subject to change. US Customers, contact Abbott
Diagnostics Customer Service at 1-877-4ABBOTT (1-877-422-2688) for the most current information regarding
list numbers. Customers outside the US, contact your local Hematology Customer Support Representative.
CELL-DYN 1600/1600CS
CELL-DYN Reagents
US-Only List No. Rest of World Description Configuration
List No.
08H17-01 99226-01 Diluent, Diff-Screen 4 x 3.8 Liters
08H17-04 99220-01 Diluent, Diff-Screen 1 x 20 Liters
08H17-02 99229-01 Diluent, Diff-Screen 1 x 3.8 Liters
08H18-02 98329-01 Detergent, Diff-Screen 1 x 3.8 Liters
08H18-01 99326-01 Detergent, Diff-Screen 4 x 3.8 Liters
08H18-04 99320-01 Detergent, Diff-Screen 1 x 20 Liters
08H19-02 99435-01 Lytic Agent, Diff-Screen 1 x 960 mL
08H19-01 99420-01 Lytic Agent, Diff-Screen 1 x 3.8 Liters
CELL-DYN Controls & Calibrators

Abbott List No. Description Configuration
99109-01 CELL-DYN 16 Tri-Level Control 12 x 2.5 mL
02H40-01 CELL-DYN 16 Normal Control 6 x 2.5 mL
01H92-01 CELL-DYN 16 Control Assay Disk Disk
99103-01 CELL-DYN 22 Normal Control 12 x 2.5 mL
01H91-01 CELL-DYN 22 Control Assay Disk Disk
99110-01 CELL-DYN Calibrator 2 X 2.5 mL
99120-01 CELL-DYN 22 Calibrator 2 X 2.5 mL
x CELL-DYN® 1600 Operator’s Manual

9140214 Rev H—May 2004
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 µL 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
99605-01 CELL-DYN Sample Vials (US Only) 500/pkg.
99606-01 CELL-DYN Sample Vials (US Only) 3000/pkg.
99605-02 CELL-DYN Sample Vials (International) 500/pkg.
99606-02 CELL-DYN Sample Vials (International) 3000/pkg.
CELL-DYN® 1600 Operator’s Manual xi

9140214 Rev H—May 2004
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
07H67-01 Assy, Lyse Cap (1 Liter) 5
07H67-02 Assy, Lyse Cap (4 liter) 5
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, to place an order for products that have a List
Number, or if you require technical assistance with your CELL-DYN instrument, contact Abbott Diagnostics
Customer Service at the number provided on page iv.
xii CELL-DYN® 1600 Operator’s Manual

9140214 Rev H—May 2004
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

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 innediately prior to running any specimens.

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.

9140214 Rev F—April 1996
Chapter 2 Installation
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 ON. 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
Installation Chapter 2
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 ON.
ATTENTION Check all side and rear panel connectors for particles or foreign material that can
impair electrical contact when connections are made.
Table 2-1
Power Source Requirements
Nominal Line Operative Range Operative

Voltage Cycles
100 90-110 VAC 50Hz
100 90-110 VAC 60Hz
115 105-125 VAC 60Hz
215 195-235 VAC 50Hz
230 210-250 VAC 50Hz
The CELL-DYN 1600 is designed for low power consumption. The instrument
automatically performs an initialization cycle whenever power is turned ON.
During the daily routine operating period, power should be left ON.

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 OFF 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.
Figure 2-1 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 OFF. Plug the power cord into
the printer. Do not plug the other end into a grounded outlet until you are
ready to power ON.
3. Locate the ribbon cable in the accessory kit and attach it to the connector
labeled Parallel Interface. (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
ON.
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 OFF. 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 TICKET
PRINTER which is just below the PARALLEL INTERFACE 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 ON. 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 H—May 2004
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.
Figure 2-2 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 WASTE connector located on the left panel.
When the waste tube is placed directly into a drain, insert a "dummy"
plug into the WASTE connector. If a "dummy" plug is not inserted, the
WASTE FULL 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
syringe until it touches the
Figure 2-3 Diluent Syringe
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.
Figure 2-4 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 ON for the
analyzer to operate correctly.
Figure 2-5 Flow Panel

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 <DILUENT EMPTY> 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 ON. Confirm that the graphic printer
paper is installed and feeding correctly.
3. Move the analyzer's power switch to ON. The screen illuminates within
15 to 30 seconds and the statement <MAIN MENU INITIALIZING>
appears in the upper center screen System Status box. When the cycle is
complete, the message INITIALIZED 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 [RUN] key is pressed and
INITIALIZED or STANDBY 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 MAIN MENU is displayed. At the completion of each Power On
Initialization cycle, the MAIN MENU is displayed with the cursor flashing at the
<OPERATOR ID> 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 MAIN
MENU is displayed.
NOTE An Operator ID is not required for system operation.
The Sequence Number

The Sequence Number display below the <OPERATOR ID> 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 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.

9140214 Rev D—June 1993
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 D—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 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 Go to the Date/Time Setup procedure.
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.
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 SETUP MENU, press [DATE/TIME].
The SETUP DATE/TIME MENU 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 [RETURN] to return to the SETUP MENU.
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 [RETURN] to return to the SETUP MENU.
Patient Range Entry Key

Upper and lower alert limits for patient specimen results can be entered,
reviewed, and changed as required via the [PAT RANGE ENTRY] 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 SETUP MENU press [PAT RANGE ENTRY].
The PATIENT RANGE ENTRY screen displays.
2. ARE THE LIMITS ACCEPTABLE?
YES Press [RETURN] to return to the SETUP MENU.
NO Use the Arrow 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 Enter to move the cursor to the next field.
Press [RETURN] to return to the SETUP MENU.

9140214 Rev D—June 1993
Reagents Log Key [REAGENTS LOG] 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 SETUP MENU, press [REAGENTS LOG].
The SELECT REAGENT screen displays.
2. Select a Reagent Log by pressing the appropriate keypad:
[DILUENT], [LYSE], or [DETERGENT]
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 Enter. The cursor moves to the next
field.
4. Press [PRINT] to print the log.

5. Press [RETURN].
Repeat steps 2-4 for each reagent type.
OR
To return to the SETUP MENU, press [RETURN], and then [SETUP].
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 SETUP MENU, press [CTL FILE SETUP]
The message <PRESS SOFTKEY> displays in the Status Box.
2. Press the corresponding key for the type of control to be updated:
[LOW CONTROL], [NORMAL CONTROL], or [HIGH CONTROL].
The CTRL FILE SETUP screen displays.
3. IS THE LOT NUMBER ENTRY ACCEPTABLE?
YES Press Enter.
Go to step 4.
NO Enter the lot number (up to nine digits) and press Enter.
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 Enter to advance the cursor.
4. IS THE EXPIRATION DATE ENTRY ACCEPTABLE?
YES Press Enter.
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 Enter.
Repeat this process until all rule selections are acceptable.
Go to step 6.
6. REVIEW RANGE OR MEAN/LIMITS?

YES Press [RANGE] or [MEAN/LIMITS]. The screen for the
selected control file displays.
Go to step 7.
NO Press [RETURN] to return to CONTROL FILE SETUP MENU.

9140214 Rev D—June 1993
7. ARE THE VALUES ACCEPTABLE?

YES Go to step 8.
NO Use the Arrow 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 Enter 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 [PRINT].
NO Go to step 9.
9. IS ANOTHER CONTROL SETUP REQUIRED?

YES Press [RETURN] twice to return to the FILE SETUP MENU.
Repeat steps 2-9 for each control as required.
NO Press [RETURN] twice.

Press [SETUP] to return to SETUP MENU 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 [REP FILE SETUP], 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 [PURGE] for that control.

9140214 Rev D—June 1993
To Enter Flag Information

1. At the SETUP MENU, press [REP FILE SETUP].
The <ENTER REPLICATE FILE #> message displays in the Status Box.
2. Enter the replicate file number.
The REPLICATE 'n' FILE SETUP screen displays.
3. IS THE LOT NUMBER ENTRY ACCEPTABLE?
YES Press Enter.
Go to step 4.
NO Type lot number, or other identifier, up to nine digits. Press

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

YES Press Enter.
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 Enter.
Repeat this process until all rule selections are acceptable.

Go to step 6.
6. REVIEW RANGE OR MEAN/LIMITS?

YES Press [RANGE] or [MEAN/LIMITS] to display the screen for
the selected control file.
Go to step 7.
NO Press [SETUP] to return to SETUP MENU.

9140214 Rev D—June 1993

YES Go to step 8.
NO Use the Arrow 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 Enter 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 [PRINT].
NO Go to step 9.
9. IS ANOTHER REPLICATE FILE REQUIRED?

YES Press [RETURN].
Repeat steps 2-9 for each file, as required.

NO Press [RETURN] then [SETUP] to return to SETUP MENU
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 X-B FILE SETUP screen, to automatically exclude these specimens from the
program.
To Use the X-B Function

1. At the SETUP MENU, press [X-B SETUP].
The X-B FILE SETUP screen displays, and the cursor is on the first MCV
limit.

YES Press [SETUP] to return to SETUP MENU 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 Enter key to
store the data and advance the cursor.
3. Press [SETUP] to return to SETUP MENU screen.
Auto-Startup Cycle
The Auto-Startup cycle activates anytime the [RUN] key is pressed and either
INITIALIZED or STANDBY 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 RUN 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 <MAIN MENU, INITIALIZED> must be displayed in the Status
Box of the MAIN MENU screen.
1. To start the cycle, press [RUN].

2. The message <RUN MENU, READY> displays in the Status Box when
the cycle is complete.
3. Press [SPECIMEN TYPE] to display the next screen.
4. Press [NORMAL BACKGROUND]. The MAIN RUN MENU 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.
Table 2-3
Acceptable Background and Count Time Data
Background Count Time
WBC <00.5 K/UL 5.00 ±1.00 S
RBC <0.05 M/UL 7.00 ±1.00 S
HGB <00.2 g/dL
PLT <010. K/UL
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 µL 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.

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 / µL
• LYM # K / µL and %
• GRAN # K / µL and %
• MID # K / µL 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 / µL
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 / µL
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


result.)
Cause: LYM data in the region to the right of 35 fL are outside the
normal criteria.
Lymphocytosis
Lymphopenia
Cryoglobulins

result.)
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.


smear to confirm the results. This flag may be caused by:
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/µL and the
mean channel location is above 150 fL, or if the mean channel
location exceeds 287 fL.

smear to confirm results. This flag may be caused by:
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: 15ºC to 30ºC (59ºF to 86ºF)
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 µL
• Pre-Dilute Mode: 40 µL
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 µm in diameter x 60 µm 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 µm in diameter x 70 µm 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.

9140214 Rev H—May 2004
Performance Specifications
Background Counts
Background Counts must be within the following specifications:
Parameter Background Count

WBC < 0.5 K/µL
RBC < 0.05 M/µL
HGB < 0.2 g/dL
PLT < 10.0 K/µL
NOTE Background specifications apply only to the WBC, RBC, HGB, and PLT
parameters. There are no specifications for other parameters and any values
displayed for them in background mode should be disregarded.
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).
NOTE Results that exceed the linear range must be confirmed by diluting the specimen
until the result falls within the appropriate linear range and then correcting that
result for the dilution in order to obtain a reportable result.
Table 4-4 Linearity Specifications
Parameter Linear Range Allowable Limit +/-

WBC* 1.0 - 99.9 K/µL +/- 0.4 or 3.0%
RBC 1.00 - 7.00 M/µL +/- 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/µL +/- 12 or 4.0%
*Linearity specification determined by use of commercially available control material.

9140214 Rev H—May 2004
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.

9140214 Rev H—May 2004
Table 4-5 Precision at 25ºC
Parameter Typical1 Typical2 Typical3 Absolute4

within Sample within Day Day to Day within Sample
WBC (K/µL) 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/µL) 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/µL) 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/µL) 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 (%)CV 10.6 - 14.8 10.6 - 14.8 10.6 - 14.8 10.6 - 14.8
< 3.0% < 3.5% < 4.0% < 3.5%
PLT (K/µL)CV 142 - 424 142 - 424 142 - 424 142 - 424
< 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

9140214 Rev H—May 2004
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 D—June 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.

9140214 Rev D—June 1993
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.

9140214 Rev D—June 1993
Pre-Dilute [PRE-DILUTE] turns the pre-dilute mode run cycle ON and OFF. When ON, the
<PRE-DILUTE> message appears in the upper left 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.

9140214 Rev H—May 2004
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.

9140214 Rev D—June 1993
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 D—June 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 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.

9140214 Rev F—April 1996
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 the maximum number that can be displayed for that
parameter are indicated by >>>> in place of the result.
The maximum numbers that can be displayed are:
WBC 99.9 HGB 99.9
RBC 9.99 PLT 999
Please refer to Chapter 10, Troubleshooting, Table 10.1 Troubleshooting
Guide, for instructions for handling these specimens.
• 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.

9140214 Rev H—May 2004
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

1. Check that there is sufficient reagent to complete the run.
2. Check that there is sufficient paper in the printer to complete the run.
3. Check that the tubing is properly seated in the Normally-Closed valves.
4. If necessary, put the Lyse Pump tubing under the wheel.
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 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. The message <RUN MENU,
READY> displays in the Status Box when the cycle is complete.
3. Perform a Background Count Check as follows:

A. Press [SPECIMEN TYPE] to display the Specimen Type Screen.
B. Press [NORMAL BACKGROUND]. The CELL-DYN 1600 RUN MENU
displays.
C. Press the Touch Plate to start the background cycle. No specimen is required.
D. Repeat step C until the Background Counts are acceptable for 3 consecutive
cycles. (Refer to Chapter 4, System Specifications for Background Count
Limits.)
NOTE Confirm that the count times are also acceptable for 3 consecutive cycles.
WBC: 5.00 ± 1.00 Sec., RBC 7.00 ± 1.00 Sec.
4. Perform the daily Quality Control checks as directed in the following section.

9140214 Rev H—May 2004
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 below.
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 beep sounds. 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.

9140214 Rev H—May 2004
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.
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]

9140214 Rev H—May 2004
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].
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.

9140214 Rev H—May 2004
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.
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 H—May 2004

9140214 Rev D—June 1993
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, and PLT 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 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.

9140214 Rev H—May 2004
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
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.
Commercial Calibrator Guidelines

For commercial calibrators, follow the directions given in the package insert. Be
certain to carefully read and follow directions given for warming and mixing.
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 calibrators
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.

9140214 Rev H—May 2004
• 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 K/µL
RBC 3.50 — 5.50 M/µL
HGB 10.0 — 24.0 g/dL
MCV 80 — 100 fL
HCT 30.0 — 50.0 %
PLT 150 — 400 K/µL

9140214 Rev H—May 2004
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 D—June 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.

9140214 Rev D—June 1993
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

9140214 Rev D—June 1993
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.
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.

9140214 Rev F—April 1996
Calibration Menu Screen

The CALIBRATION MENU screen is accessed from the MAIN MENU screen by
pressing [CALIBRATION]. The CALIBRATION MENU screen is explained in this
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] a reference value for MPV is not currently available.
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.

9140214 Rev H—May 2004
CELL-DYN 1600
Pre-Calibration Procedures Check List
Introduction
It is advisable to perform calibration at a time when it can be completed without interruption. The
Pre-Calibration Procedures help ensure proper instrument performance and a successful
calibration. These steps must be completed just before starting the calibration process. If problems
are detected during these checks, do not attempt to calibrate the instrument. If necessary, call
Abbott Diagnostics Customer Service for assistance. After the problems have been resolved, repeat
the Pre-Calibration Procedures to verify proper performance.
Instrument: _________________________ Date:_________________________
Operator:___________________________
1. ________ Confirm that the Operator ID number is entered.
2. ________ Ensure that all maintenance is current before calibrating the instrument. Refer to the
CELL-DYN 1600 Operator’s Manual Chapter 9: Maintenance for further
information.
3. ________ Confirm that reagent containers are at least half full—replace them as necessary.
4. ________ Verify that the CELL-DYN Reagents have not reached the expiration date. Record the
reagent expiration dates and lot numbers in the spaces provided below.
Diluent: Lot #________________ Expiration Date _________________
Detergent: Lot #________________ Expiration Date _________________
Lytic Agent: Lot #________________ Expiration Date _________________
5. ________ Verify that the calibrator has not reached the expiration date.
Lot #________________ Expiration Date _________________
6. ________ Confirm that the waste container is not more than half full—empty it, if necessary.
7. ________ Confirm that Normal Background is within limits. Record the background results
below and attach a printout to this document. If the system has been idle for fifteen
minutes or more, a Normal Background should be run immediately prior to running
any calibration specimens.
WBC < 0.5 K/µL __________________
RBC < 0.05 M/µL __________________
HGB < 0.2 g/dL __________________
PLT < 10.0 K/µL __________________

9140214 Rev H—May 2004
8. ________ Verify instrument precision by analyzing a fresh, normal whole blood sample 10
times in succession. Run the sample in an empty replicate file and record the CVs
below and attach a file printout to this document. The CVs obtained should be less
than or equal to the CV% limits listed below. Refer to the CELL-DYN 1600
Operator’s Manual Chapter 5: Operating Instructions, Subchapter: Daily Quality
Control Checks, for further information on using the replicate files.
Parameter CV% Limit CV
WBC < 2.5 __________________
RBC < 1.7 __________________
HGB < 1.2 __________________
MCV < 1.5 __________________
PLT < 6.0 __________________
9. ________ If any problems are detected, document them with your corrective action in the space
provided:
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

9140214 Rev H—May 2004
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.

9140214 Rev H—May 2004
9. Mix the specimen well by inverting it at least 10 times. Do not shake the
specimen.
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

9140214 Rev H—May 2004
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.
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.
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).

9140214 Rev H—May 2004
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].
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.

9140214 Rev H—May 2004
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 H—May 2004
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.

9140214 Rev H—May 2004
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 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. 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.
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.

9140214 Rev H—May 2004
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.
26. Press [PRINT] to print the new calibration factors.
27. Press [MAIN].
29. Press [PRE-DILUTE] to select the pre-dilute mode.
• 3 levels of controls via the pre-dilute method.
31. Confirm that the results obtained for each specimen:
OR
NOTE If results for any parameter are consistently out, repeat the calibration or obtain
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.
NOTE The following procedure slightly differs from on-screen instructions. Both
procedures can be used for Lyse Volume Dispense Calibration.

9140214 Rev H—May 2004
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 dispense 10 mL.
4. Repeat step 3 to dispense an additional 10 mL of diluent. Determine how many

milliliters of diluent are in the cylinder.
5. Press [MAIN].
7. Press [LYSE VOLUME]. A new screen appears. Note the Current Lyse Volume
dispensed per cycle value on the bottom of the screen.
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 desired volume for lyse dispense in milliliters using the keyboard
numeric keys (0.75mL to 1.25mL), based on the current value from step 7.
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.

Determine how many milliliters of diluent are in the cylinder.
16. Place the end of the lyse tubing into a 25 mL graduated cylinder. Confirm
the end of the tubing touches the bottom of the cylinder.
19. Press [LYSE VOLUME].

9140214 Rev H—May 2004
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 ± 0.2 mL.
NOTE If the two volumes do not agree, repeat this entire procedure or obtain technical
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 H—May 2004
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:
• Select 1 of 12 QC files
• 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
• 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.
• Never subject any vial to excessive heat or agitation.

• 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 Abbott Diagnostics Customer Service.
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.

9140214 Rev H—May 2004
The individual SD values may be averaged as follows:
(N1 x×SD
(N1 2 2 + (N2 × SD2
SD1
1 ) +) (N
2
(Ni x SDi×2)S
2 x SD2 ) + ...)+...(Ni
2
Average SD =
(N1
(N ++NN2 + ...
+ ...N ) -Ni)
1 - 1
1 2 i
N = number of values in a group

SD = standard deviation of the values
i = the last group of values
The resulting 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.

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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.
CAUTION Do not use the values for mean range provided on the control assay sheet in
conjunction with Westgard Rules. Before using Westgard Rules with
commercial controls, establish the SD for each parameter on your instrument
and enter limits based on these SDs.
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.

9140214 Rev H—May 2004
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 Abbott Diagnostics Customer
Service 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.

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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
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.

9140214 Rev H—May 2004

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.

9140214 Rev F—April 1996
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.

9140214 Rev F—April 1996
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 D—June 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 D—June 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 D—June 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 D—June 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. ‘T’ Fitting Cleaning (page 9-26)
8. Vent Line Cleaning (page 9-27)
9. Accumulator Draining and Cleaning (page 9-28)
10. Preparing the Analyzer for a Prolonged Period of Non-Use or for Shipping
(page 9-28)
11. 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 H—May 2004
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 D—June 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/Lint-free wipe
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 H—May 2004
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
before running any unknown specimens.

9140214 Rev D—June 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.

9140214 Rev F—April 1996
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.

9140214 Rev F—April 1996
2. Perform 2 or 3 lyse prime cycles by pressing [LYSE PRIME].

3. Run background counts until acceptable results are obtained for
all background parameters.
4. Run commercial controls or QC specimens to confirm proper
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.

9140214 Rev F—April 1996
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
Manual Cleaning an organic build-up is suspected of causing any of the
following:
1. Elevated HGB results
2. HGB imprecision
‘T’ Fitting Cleaning As needed
Vent Line Cleaning When the vent line is restricted and prevents the
formation of a proper meniscus in the metering tube.

9140214 Rev H—May 2004
Procedure Frequency
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 D—June 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 D—June 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 D—June 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. Place each aperture plate into the beaker of cleaning solution prepared in step 7.
Completely immerse each plate in the cleaning solution.
9. Allow the plates to soak for AT LEAST 5 minutes and NO LONGER than 15
minutes.
10. Clean debris from each aperture plate by rotating the camel hair aperture brush
provided in the accessory kit.
CAUTION Use only the brush provided. Use of other items or brushes will damage the
aperture plate.
11. Remove each aperture plate from the cleaning solution and thoroughly rinse it
with a fine stream of deionized water. Do not dry the aperture plates.

9140214 Rev H—May 2004
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 D—June 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 µL) syringe.
new labels appear.
5. Press [CLEAN DIL SYRINGE]. The diluent syringe plunger moves up.

9140214 Rev D—June 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 D—June 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 D—June 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
Sample Syringe Cleaning
Materials Required
Large basin
Deionized water
Procedure
1. At the MAIN MENU, press [SPECIAL PROTOCOLS]. A new screen
and 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 D—June 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 D—June 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.

8. Press [MAIN] to return to the MAIN MENU.

9140214 Rev D—June 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 D—June 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 D—June 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
lower 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 Fig-
ure 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. Close valve #26. 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 H—May 2004
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.
19. Run commercial controls or QC specimens to confirm proper performance before
running any unknown specimens.
Pinch Valve 26
Insert Syringe Here Detach Here Wire Puller
Figure 9-6 HGB Flow Cell Manual Cleaning

9140214 Rev H—May 2004
‘T’ Fitting Cleaning

Materials Required
• Powder-free gloves, lab coat, safety glasses
• 25% cleaning solution (1 part of 5% sodium hypochlorite added to 3 parts
of warm water)
• Small beaker
• 5 mL syringe
• Plastic disposable pipettes
Procedure
This procedure is used to remove very stubborn restrictions in the ‘T’ fitting
under the pre-mix cup and/or when the pre-mix cup is overflowing.
1. Remove front covers.

2. Carefully remove the liquid inside the pre-mix cup with a disposable pipette and
discard according to local, state, and federal regulations.
3. Locate the ‘T’ fitting below the pre-mix cup.
4. Carefully remove the tubing on all three sides of the ‘T’ fitting.
5. Place the ‘T’ fitting inside the beaker. Pour the 25% cleaning solution into the
beaker. Soak for five minutes.
6. Fill a syringe with water.
NOTE DO NOT use hypodermic needles as they may puncture the fitting and tubing.
7. Using the syringe, flush water through all three sides of the fitting, verifying that
water flows freely from all three outlets. Rinse off fitting with water and blot dry.
8. Replace tubing to all three sides of the ‘T’ fitting.
9. Run background counts to verify the pre-mix cup is draining completely and there
are no leaks originating from the fitting. Verify that acceptable results are obtained
for all background parameters.
10. Replace front covers.
11. Run and verify commercial controls or QC specimens to confirm proper
performance before running any patient specimens.

9140214 Rev H—May 2004
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 H—May 2004
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 H—May 2004
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 H—May 2004
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 H—May 2004
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.
9. Press [MAIN] to return to the MAIN MENU.
10. Run commercial controls or QC specimens to confirm proper

9140214 Rev H—May 2004
9-32
PREVENTIVE MAINTENANCE LOG FOR CELL-DYN 1600
Maintenance
INSTRUCTIONS: 1. Keep this sheet as a master copy.

2. Check off appropriate month and enter year.
3. Check off performance of maintenance and initial in appropriate day.
YEAR DATE 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Check Reagent Levels
Check Printer Paper
Check Tubing in NC Valves
DAILY
START-UP Put Lyse Pump Tube under
wheel (if required)
Do Background Check
Run Controls
DAILY Do Daily Shutdown

SHUT-
Empty Waste (as needed)
DOWN
Open and CS mode-Auto

Clean
Aspiration Probe Exterior
WEEKLY
Cleaning
Closed Sampler Holder
Cleaning
Check Lyse Pump Tubing

Clean Lyse Inlet Line
MONTHLY
Remove and Clean Fan
Filters
CELL-DYN® 1600 Operator’s Manual

9140214 Rev H—May 2004
Chapter 9
Chapter 9
PREVENTIVE MAINTENANCE LOG FOR CELL-DYN 1600
YEAR DATE 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
QUARTERLY Replace Lyse Pump
9140214 Rev H—May 2004

Tubing
Supplemental Aperture
Cleaning
CELL-DYN® 1600 Operator’s Manual

Aperture Plates Cleaning
Diluent Syringe Cleaning
Sample Syringe Cleaning
Sample Aspiration Probe
Interior Cleaning
As HGB Flow Cell Manual
Needed Cleaning
‘T’ Fitting Cleaning
Vent Line Cleaning
Accumulator Draining and
Cleaning
Replace Closed Sample
Peristaltic Pump Tubing
Calibrate As Needed
JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC
9-33
Maintenance

9140214 Rev H—May 2004
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 D—June 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 functivon 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 D—June 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 D—June 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 D—June 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 Abbott Diagnostics Customer Service.
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 H—May 2004
Obtaining Technical Assistance

Technical Assistance is obtained by calling Abbott Diagnostics Customer
Service. It is important to provide the Customer Support Specialist with a clear
and detailed description of the problem. When assistance is needed, please be
prepared to provide the following information for the Customer Support
Specialist:
1. Instrument model number

2. Serial number of the analyzer and software version in use
3. Description of the problem (whenever possible, print the fault status
report obtainable from the DIAGNOSTICS MENU screen)
4. The lot numbers and expiration dates of the CELL-DYN reagents and
controls currently in use
5. Examples of sufficient data to facilitate the discussion

9140214 Rev H—May 2004
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(s) Required Action

> > > > appears in Data exceed the For RBC or HGB: Dilute 0.5 mL aliquot of well-
place of result. maximum number that mixed whole blood with 0.5 mL diluent (1:2 ratio).
can be displayed for that Close the container and invert it 10 to 15 times to
parameter as follows: mix. Run the specimen as usual. Multiply the RBC
or HGB result by 2 to obtain a reportable value.
WBC 99.9
For WBC or PLT: Dilute 0.5 mL aliquot of well-
RBC 9.99 mixed whole blood with 0.5 mL of diluent (1:2
HGB 99.9 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
PLT 999 it 10 to 15 times to mix. Run this specimen as usual.
Multiply each WBC or PLT result by 2, 3, 4, or 10
(per ratio of diluent to blood used above) to obtain
a reportable value.
Improper reagent Inspect syringes for proper operation.
delivery or sample
aspiration Check Reagent Inlet Lines for crimping.
> > > > appears in Wash block and Perform the probe removal and replacement
place of RBC or probe misaligned. procedure described in Chapter 9: Maintenance.
PLT result. Confirm the probe is properly installed and aligned.
Obtain technical assistance.
Abnormal or Dirty HGB flow cell. Perform the hemoglobin flow cell manual cleaning
erratic HGB, procedure as described in Chapter 9: Maintenance.
MCH, and/or
MCHC results.

9140214 Rev H—May 2004
Table 10-1. Troubleshooting Guide (continued)
Condition Probable Cause Required Action

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
59°F or 15°C. background data are not acceptable, go to the next probable
cause.
Contaminated bath Perform the Auto-Clean procedure described in Chapter 9,

and/or 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
<CLOG> is protein build-up is the clog limit. If the situation occurs repeatedly, go to the
displayed in restricting fluid flow SPECIAL PROTOCOLS MENU and run the Auto-Clean
place of Count through the aperture. procedure. Perform manual aperture cleaning. Check the
Time. 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 diluent tube. If the situation occurs repeatedly, perform the
closed valve, or reagent maintenance procedures to prepare the unit for shipping. Use
particles may be in the a 1:4 ratio of 5% sodium hypochlorite to water.
flow panel.

9140214 Rev F—April 1996

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 that the large knurled thumb nut on the bottom of the syringe
nut has vibrated loose. is fully tightened—if not, tighten finger tight.
The message Air bubbles are trapped Press [CLEAR ORIFICE] to backflush the aperture and reset
<FLOW ERR> is in the dilution baths. the clog limit. Rerun the specimen. If the situation occurs
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.

9140214 Rev F—April 1996

The message Aperture plates installed Check plate installation. Confirm that the aperture plate
<FLOW ERR> or in wrong baths. marked "R/P" is installed in the RBC/PLT bath located to the
<CLOG> is right of the probe. Confirm that the aperture plate marked
displayed in "WBC" is installed in the other bath.
place 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)
a good meniscus in the below the aspirate probe. Observe fluid flow and meniscus
metering tube. formation 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
Insufficient liquid in the Remove the upper front cover and open the left panel to gain
bath. Air is drawn access to the flow panel and syringe panel. Press the touch
through the aperture. plate. Observe the action of the diluent syringe and the fluid
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
Flow system leak. Check the system for leaks or cracks.

Damaged aperture. Check the aperture under a microscope using a low power
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.

9140214 Rev F—April 1996

Keypad Computer busy Refer to the screen for current status messages; counting,
selection or performing a function etc.
entry not that prevents screen
accepted. label selection.
Data being transmitted None required.

to printer or computer.
Keypad entry not None required.

allowed for this screen.
Computer, keypad, Turn the power OFF. Wait 30 seconds. Turn the power
and/or circuitry back ON. If the situation is not corrected, obtain technical
malfunction. assistance.
<LYSE conductivity was Chapter 2, Installation.
No liquid was detected Confirm that the end of the lyse tube is immersed in
by the internal lyse reagent. When the container is empty, replace it with a
sensor. fresh container of lyse. Press [CLEAR FAULT].
Lyse pump tubing is Replace lyse pump tubing if there are signs of deterioration
worn out. or if the tubing is over 3 months old.
Lyse inlet tubing is Perform lyse inlet tubing flush procedure.

clogged.
NOTE Never pour the reagent remaining in an old
container into a freshly opened container.

9140214 Rev D—June 1993

No power. Power cord is loose or Confirm that the power cord is inserted securely into both
not securely connected the rear panel connector and wall outlet(s). Confirm that
to the unit or wall the plug prongs are not bent.
socket.
Power switch is OFF. Move the rear panel power switch to ON.
No voltage or wrong Confirm that the fuse and circuit breaker at facility (site)
voltage at the lab power are acceptable. Confirm that the analyzer's rear panel
receptacle. 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 Cycle in process but not None. Refer to the screen for current status.
labels. 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
results exceed handling of the QC handling of QC specimens.
acceptable specimen.
limits.
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.
Remove the upper front cover. Press the touch plate.

Insufficient or no Observe the bubble mix in each bath. As required, obtain
dilution mixing. technical assistance.
Run cycle will Defective diskette or Turn the power switch OFF. Replace the system diskette
not stop. diskette drive. with the spare supplied with the analyzer. Obtain technical
assistance.

9140214 Rev D—June 1993

Specimen will Fibrin or debris is in the Check the specimen for fibrin clots or red cell
not aspirate. specimen aspiration agglutination. Redraw the specimen as required. Check the
probe. probe for fibrin 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
activated for 4 hours. perform a background check.
The 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
IZED, SEE during initialization displayed with the required operator action. As required,
DIAGNOS- cycle. obtain technical assistance.
TICS> is
displayed.
The message Liquid level in the Remove the waste stopper assembly and empty the
<WASTE waste container has container. Press [CLEAR FAULT] to continue. Make sure
FULL> is tripped the sensors. liquid is wiped from stopper and top of bottle to ensure
displayed. good seal.
CAUTION Liquid is a possible biological and chemical
hazard. Follow good laboratory safety
practices.
Waste sensor plug is Reinsert the plug into receptacle, then press [CLEAR
not inserted completely FAULT] to continue. Turn power OFF. Wait 10 seconds,
in lower left side panel then turn power ON.
receptacle. An audible
tone sounds to alert the
operator.
Defective component. Obtain technical assistance.
Waste full, no Waste sensor plug dirty. Clean plug with alcohol and reinsert fully.
message
displayed. Loose wire in waste Obtain technical assistance.
cap.

9140214 Rev D—June 1993

WBC and/or No lyse reagent added. Remove lyse tube from flow panel normally closed valve
HGB data are Pinched or cracked lyse and roll it between your fingers. If it remains flat, replace
invalid. tubing. Malfunction of the tubing. Insert the tube in the valve. Go to the SPECIAL
lyse pump or pinch PROTOCOLS screen and press [LYSE PRIME]. Observe the
valve. 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
for MCH and/or procedure as described in Chapter 9, Maintenance.
MCHC.
Amount or timing of Perform the lyse inlet rinsing procedure described in
lyse addition not Chapter 9, Maintenance. Check tubes for cracks and leaks.
optimal. As required, obtain technical assistance.
X-B data are out Dirty aperture. Clean aperture plate as described in Chapter 9,
for MCV. Maintenance. As required, obtain technical assistance.

9140214 Rev D—June 1993
Chapter 11 Printers
Printers
Introduction The CELL-DYN 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 Abbott Diagnostics Customer
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 Abbott Diagnostics
Customer Service 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
Abbott Diagnostics Customer Service 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.

9140214 Rev H—May 2004
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 Abbott Diagnostics
Customer Service 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 Abbott Diagnostics Customer Service for
assistance.

9140214 Rev H—May 2004
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
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.

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 Abbott Diagnostics Customer Service 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

9140214 Rev H—May 2004
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 Abbott Diagnostics Customer
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.

9140214 Rev H—May 2004
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.

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 Abbott Diagnostics Customer
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.

9140214 Rev H—May 2004
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 Mean X 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?
% Bias Cal Not Required Cal Needed Do Not Cal* Y or N
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 Abbott Diagnostics Customer Service for assistance.

9140214 Rev H—May 2004
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 Fact
#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 Abbott Diagnostics Customer Service for assistance.

9140214 Rev H—May 2004
CELL-DYN 1600 Mode to Mode QC Verification
Daily Differences Logsheet
Month: ________________ Instrument:________________
DATE S3:SAMPLE ID NO. WBC RBC HGB MCV PLT MPV LYM MID GRAN %LYM %MID %GRAN TECH
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
Cryoglobulin, cryofibrinogen Clotting
Heparin Smudge cells
Monoclonal proteins Uremia plus immunosuppressants
WHITE CELL COUNT (WBC)
Nucleated red cells
Platelets clumping
Unlysed red cells
Cryoglobulin, cryofibrinogen Cold agglutinins
Giant platelets Clotted specimen (microclot)
Elevated white cell count Hemolysis (in vitro)
RED CELL COUNT (RBC)
(> 50,000/µL) Polycythemia (increased RBC
coincidence)
Microcytic red cells
Carboxyhemoglobin (> 10%) Clotted specimen (microclot)
Cryoglobulin, cryofibrinogen
Hemolysis (in vivo)
HEMOGLOBIN (HGB) Elevated white cell count
Hyperbilirubinemia, severe
Lipemia
Abnormal plasma proteins
Cryoglobulin, cryofibrinogen Autoagglutination
HEMATOCRIT (PACKED CELL
Giant platelets Clotted specimen (microclot)
VOLUME - ANALYZER
Elevated white cell count Specimen hemolysis
METHOD)
Hyperglycemia (> 600 mg/dL)
Hyponatremia Excess EDTA
HEMATOCRIT (PACKED CELL
Plasma trapping Hemolysis (in vitro)
VOLUME - MANUAL METHOD)
Hypernatremia
Autoagglutination Cryoglobulin, cryofibrinogen
High white cell count (> 50,000/µL) Giant platelets
MEAN CELL VOLUME Hyperglycemia Hemolysis (in vitro)
Reduced red cell deformability Microcytic red cells
Swollen red cells
High white cell count Spuriously low hemoglobin
(> 50,000/µL) Spuriously high red cell count
MEAN CELL HEMOGLOBIN
Spuriously high hemoglobin
Spuriously low red cell count
Autoagglutination High white cell count
Clotting (> 50,000/uL)
MEAN CELL HEMOGLOBIN
Hemolysis (in vivo and in vitro) Spuriously low hemoglobin
CONCENTRATION
Spuriously high hemoglobin Spuriously high red cell count
Spuriously low hematocrit
Cryoglobulin, cryofibrinogen Clotting
Hemolysis (in vivo and in vitro) Giant platelets
PLATELETS (PLT) 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 AT1 MONTH AT2 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)
Non-anemic heterozygous Normal Aplastic anemia

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

Hgb S-Alpha or Beta deficiency deficiency
Thalassemia Anemic hemoglobin Sickle cell anemia
Hgb H abnormalities (1/3 of cases)
Myelofibrosis Immune hemolytic
RDW Sideroblastic anemia
Myelodysplasia Cold agglutinins
(HIGH) 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

(HIGH) or H disease
S-beta thalassemia
SS and alpha
thalassemia Hgb SS Hgb SS
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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Table of Contents

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

CELL-DYN® 1600 Operator’s Manual Table of Contents—1

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

Table of Contents—2 CELL-DYN® 1600 Operator’s Manual

8. Precautions, Limitations and Hazards

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

CELL-DYN® 1600 Operator’s Manual Table of Contents—3

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

12. CELL-DYN 1600CS Closed Sample Aspiration Module

Table of Contents—4 CELL-DYN® 1600 Operator’s Manual

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

CELL-DYN® 1600 Operator’s Manual Table of Contents—5

CELL-DYN® 1600 Operator’s Manual i

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

2. Result from chemical decomposition or corrosion.

ii CELL-DYN® 1600 Operator’s Manual

CELL-DYN® 1600 Operator’s Manual iii

iv CELL-DYN® 1600 Operator’s Manual

CELL-DYN® 1600 Operator’s Manual v

CELL-DYN® 1600 Operator’s Manual vii

viii CELL-DYN® 1600 Operator’s Manual

EC REP Authorized Representative

IVD For In Vitro Diagnostic Use

REF List Number

LOT Lot Number

Use By/Expiration Date

Consult instructions for use

DILUENT Diluent Reagent

DETERGENT Detergent Reagent

LYTIC AGENT Lytic Agent

CELL-DYN® 1600 Operator’s Manual ix

CELL-DYN Controls & Calibrators

x CELL-DYN® 1600 Operator’s Manual

CELL-DYN® 1600 Operator’s Manual xi

xii CELL-DYN® 1600 Operator’s Manual

The CELL-DYN 1600CS is equipped with an attached closed sample

* Clinical significance has not been established for these parameters.

CELL-DYN® 1600 Operator’s Manual 1-1

Specimen Analyzer Components

Figure 1-1 Front Panel View

Upper Front Cover

Lower Front Cover

1-2 CELL-DYN® 1600 Operator’s Manual

Sample Aspiration Probe

Serial data (ASCII format) may be transferred to an external computer

Video Display Screen

• Numeric Keys — a block of ten numeric keys, labeled from 0 to 9, and

CELL-DYN® 1600 Operator’s Manual 1-3

Figure 1-2 Flow Panel

RBC/PLT Metering Assembly

RBC/PLT Transducer Assembly

1-4 CELL-DYN® 1600 Operator’s Manual

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

WBC Metering Assembly

WBC Transducer Assembly

• WBC Transducer — The transducer contains two chambers. The

CELL-DYN® 1600 Operator’s Manual 1-5