$%%277 cell-dyn 1600 system - block scientific blogs® 1600 operator's manual table of...

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CELL-DYN® 1600 SystemOPERATOR’S MANUAL

LIST NO: 92352-01

Click on item below:• Table of Contents• Introduction• System Descri ption• Installation• Princi ples of O peration• System S pecifications• Operatin g Instructions• Calibration• Qualit y Control• Precautions, Limitations, Hazards• Maintenance• Troubleshootin g• Printer• Closed Sam pler Module• Appendices

ABBOTT LABORATORIES ENTIRE CONTENTS COPYRIGHTABBOTT PARK, IL 60064 U.S.A. ABBOTT LABORATORIES 1993

PRINTED IN U.S.A.

CELL-DYN® 1600 Operator's Manual Table of ContentsCC19140214 Rev ECFebruary 1994

Table of Contents

Introduction Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iProprietary Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iAbbott Instrument Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iiAbbott Customer Support Center . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ivConventions Used in This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vRevision Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viiSignature Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viiiReference List of Trademarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ixPart Number List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

1. System Description

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1Specimen Analyzer Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2Data Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3Flow Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4Lower Left Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8Upper Right Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8Reagent System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9

2. Installation Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1Initial Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1Printer Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3Tube and Diluent Syringe Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5Flow Panel Inspection and Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8Data Diskette Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10Power On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10Setup System Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11Keypad Setups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14Auto-Startup Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21

3. Principles of Operation

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1Sample Analysis Cycle Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1WBC Measurement Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4WBC Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5RBC/PLT Measurement Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6RBC Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8

Table of ContentsCC2 CELL-DYN® 1600 Operator's Manual

9140214 Rev ECFebruary 1994

PLT Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9PLT Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9Hemoglobin Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10Operational Messages and Data Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11Parameter Flagging Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15

4. System Specifications

Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1Data Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1Power Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2Operational Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2Measurement Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3Performance Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

5. Operating Instructions

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1Routine Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2Setup System Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6Specimen Collection and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7Sample Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7Daily Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10Power Off Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11Using the Data Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13

6. Calibration Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1Calibration Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1Whole Blood Calibration Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3Pre-Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7Calibration Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8Auto-Cal Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9Factor Entry Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11Pre-Dilute Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13Latex Particles Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16Lyse Volume Dispense Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-18

7. Quality Control

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1Quality Control Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1X-B File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1


Quality Control Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4Running Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4Westgard Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6Commercial Controls QC Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8Replicate Specimen QC Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9X-B Analysis QC Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9Establishing the Target Value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10Interpreting X-B Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11CELL-DYN Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11

8. Precautions, Limitations and Hazards

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

9. Maintenance Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1Special Protocols Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2Preventive Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2Daily Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3

Daily Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3Weekly Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4

Open Sampler Auto Clean . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4Aspiration Probe Exterior Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5Closed Sampler Auto Clean . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6Closed Sampler Holder Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7

Monthly Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8Lyse Inlet Tubing Rinsing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8Rear Fan Filters Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9

Nonscheduled Maintenance Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-10Nonscheduled Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-11

Supplemental Aperture Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-11Aperture Plates Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13Diluent Syringe Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-16Sample Syringe Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-19Sample Aspiration Probe Interior Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . 9-22HGB Flow Cell Manual Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-24Vent Line Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-26



Accumulator Draining and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-27Preparing the Analyzer for a Prolonged Period of Non-Useor for Shipping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-28Aspiration Probe Removal and Replacement . . . . . . . . . . . . . . . . . . . . . . . . 9-29

Preventive Maintenance Log for CELL-DYN 1600 . . . . . . . . . . . . . . . . . . . . . . 9-31

10. Troubleshooting

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5

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

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

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1Flow Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2Closed Sample Aspiration Module Installation . . . . . . . . . . . . . . . . . . . . . . . . . 12-3Tube Guide Adjustment Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-4Overview of the Run Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5Verification and Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5Closed Mode Calibration Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-6Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-6Closed Mode Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-7Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-8Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-10Mode to Mode Verification & Calibration Worksheet . . . . . . . . . . . . . . . . . . . 12-11Mode to Mode QC Verification Logsheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-13

Appendices

Tables Table T-1: Potential Causes of Erroneous Results withAutomated Cell Counters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . T-1Table T-2: Normal Values for Automated Blood Counters . . . . . . . . . . . . . . . . T-2Table T-3: Anemia Classification Based on MCV and RDW . . . . . . . . . . . . . . . T-3Table T-4: Progressive Stages of Iron Deficiency . . . . . . . . . . . . . . . . . . . . . . . T-3Table T-5: Morphophysiological Classification of Red Cell

Disorders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . T-4Table T-6: Result Abnormalities Caused by Artifacts . . . . . . . . . . . . . . . . . . . . T-4


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

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

CELL-DYN® 1600 Operator's Manual i9140214 Rev ECFebruary 1994

Foreword Congratulations on becoming a proud operator of the CELL-DYN® System. Usingstate-of-the-art technology, we have designed your instrument to functionconsistently and dependably on a day-to-day basis.

The CELL-DYN System is backed by dedicated professionals who excel inengineering, training and technical expertise. As a valued customer, we will teachyou how to operate, maintain and troubleshoot your system.

For continuing service, we also provide telephone technical assistance should youneed additional information or assistance in diagnosing a problem. This service isavailable 7 days a week, 24 hours a day.

If a problem should arise that cannot be resolved by telephone, on-site support isoffered by Abbott's Field Engineers. Our Field Engineers are extensively trained inall aspects of Abbott instrumentation, which assures proficiency in diagnosing,isolating and correcting problems.

Abbott Laboratories is dedicated to manufacturing the highest quality, most reliableinstrumentation available. We look forward to serving your needs in any waypossible.

Proprietary Information

Entire contents copyright 1994 by Abbott Laboratories. Abbott Laboratories'software programs are protected by copyright. All rights are reserved. This softwarewas developed solely for use with Abbott Laboratories equipment and for in vitrodiagnostic applications as specified in the operating instructions. No part of thisdocument may be reproduced, stored or transmitted in any form or by any means(electronic, mechanical, photocopied, recorded or otherwise) without the priorwritten permission of Abbott Laboratories.

The CELL-DYN instrument system is covered by the following U.S. patent:4,710,021.

All operating instructions must be followed. In no event shall Abbott be responsiblefor failures, errors or other liabilities resulting from customer's noncompliance withthe procedures and precautions outlined herein.

ii CELL-DYN® 1600 Operator's Manual


Abbott Instrument Warranty

For U.S. Customers Only

Abbott Laboratories warrants CELL-DYN® Instruments sold by Abbott SalesRepresentatives (the "Instrument") to be free from defects in workmanship andmaterials during normal use by the original purchaser. This warranty shall continuefor a period of one (1) year, commencing twenty-one (21) days from date ofshipment to the original purchaser, or until title is transferred from the originalpurchaser, whichever occurs first (the "Warranty Period").

If any defects occur during the Warranty Period, contact your Abbott CustomerSupport Center immediately and be prepared to furnish pertinent details concerningthe defect, the Instrument model number and the serial number.

Abbott's Warranty coverage limits are as follows:

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

2. 8:30 a.m.-5:00 p.m. (Monday-Friday, excluding all Abbott-observedholidays) Field Service Engineer support.

3. Any on-site service performed at other times, and all service required tocorrect defects or malfunctions not covered by this Warranty (as noted in theparagraph 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 weekof occurrence.

2. Result from chemical decomposition or corrosion.

3. Are caused by customer or third party abuse, misuse or negligence, or byfailure to comply with any requirement or instruction contained in theapplicable Abbott Operator's Manual.

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

CELL-DYN® 1600 Operator's Manual iii9140214 Rev ECFebruary 1994

Abbott's liability for all matters arising from the supply, installation, use, repair andmaintenance 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 theInstrument or of components thereof. In no event shall Abbott be liable for injuriessustained 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 theInstrument and Abbott specifically disclaims all other warranties, expressed orimplied, including the implied warranties of merchantability and of fitness for aparticular purpose.

The CELL-DYN® 1600 Series Hematology Systems are manufactured by AbbottDiagnostics, a wholly owned subsidiary of Abbott Laboratories, Abbott Park, IL60064, U.S.A. Please direct all inquiries concerning information in this manual tothe foregoing address.

NOTE Direct all inquiries regarding equipment problems to the Abbott Customer SupportCenter. (U.S. customers only.)

iv CELL-DYN® 1600 Operator's Manual


Abbott Customer Support Center

5440 Patrick Henry DriveSanta Clara, CA 95054

1-800 CELLDYN (235-5396)

CELL-DYN® 1600 Operator's Manual v9140214 Rev ECFebruary 1994

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, Initialfunction keypad Capital letters

Status Helvetica equivalent, CAPITAL letters

Message Helvetica bold equivalent,CAPITAL letters, enclosed in <>

vi CELL-DYN® 1600 Operator's Manual


CELL-DYN® 1600 Operator's Manual vii9140214 Rev FCApril 1996

The Revision status of the manual is indicated below. Be sure that the manual contains the latest revision numberof all pages.

REVISION STATUS

Revision Number Pages Revised and Added

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

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

9211352C B 12/92 Added cross-reference Part Number list and namechange from Unipath to Abbott Laboratories.

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

92352-01D B 6/93 All pages (Part No. 9140214 Rev D B June 1993).

92352-01E - 12/94 Introduction: updated telephone numbers, patents,trademarks, and parts lists (pp. i, iv, ix, x, xii);Chapter 1: deleted reference to DYN-A-PAK (p. 1-10); Chapter 3: added description of WBC R4 flag(p. 3-15); Chapter 4: added information regardingmaterial used to verify linearity specifications (p. 4-3); Chapter 7: modified assay and differentialpercent verification guidelines (pp. 7-5 and 7-6);Chapter 12 (Closed Sampler Aspiration Module):added instructions for closed mode performanceverification with patient samples (p. 12-8).

92352-01F - 4/96 The following pages have changed (Part No. 9140214 Rev F B April 1996): Introduction (p. vii and viii); Chapter 1 (p. 1-9 and 1-10); Chapter 5 (p. 5-7, 5-8, 5-9, and 5-10); Chapter 6 (p. 6-7 and 6-8); Chapter 7 (p. 7-5, 7-6, 7-9, and 7-10); Chapter 8 (p. 8-1 and 8-2); Chapter 9 (p. 9-7, 9-8, 9-9, 9-10, 9-31, and 9-32); Chapter 10 (p. 10-7, 10-8, 10-9, and 10-10); Chapter 12 (p. 12-5, 12-6, 12-9, 12-10, 12-11, and 12-12).

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

viii CELL-DYN® 1600 Operator's Manual

9140214 Rev FCApril 1996

This page has been added in order to maintain a record of persons who review this manual on a periodic basis.

Signature Date

CELL-DYN® 1600 Operator's Manual ix9140214 Rev ECFebruary 1994

Reference List of Trademarks

The following trademarks are referred to throughout this manual:

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

Vacutainer is a registered trademark of Becton Dickinson and Company.

x CELL-DYN® 1600 Operator's Manual


Part Number List

CELL-DYN 1600/1600CS

CELL-DYN Reagents

Abbott List No. Description Configuration

99226-01 Diluent, Diff-Screen 4 x 3.8 Liters

99220-01 Diluent, Diff-Screen 1 x 20 Liters

99229-01 Diluent, Diff-Screen 1 x 3.8 Liters

98329-01 Detergent, Diff-Screen 1 x 3.8 Liters

99326-01 Detergent, Diff-Screen 4 x 3.8 Liters

99320-01 Detergent, Diff-Screen 1 x 20 Liters

99435-01 Lytic Agent, Diff-Screen 1 x 960 mL

99420-01 Lytic Agent, Diff-Screen 1 x 3.8 Liters

CELL-DYN Controls & Calibrators


99109-01 CELL-DYN®16 Tri-Level Control 12 x 2.5 mL

99131-01 CELL-DYN®16 Tri-Level Control (Vac Tube) 12 X 3.0 mL

99110-01 CELL-DYN®16 Calibrator 2 X 2.5 mL

CELL-DYN® 1600 Operator's Manual xi9140214 Rev ECFebruary 1994

CELL-DYN Consumables


99644-01 CELL-DYN® Enzymatic Cleaner 2 X 50 mL

93641-01 CELL-DYN® Enzymatic Cleaner 1 x 50 mL

99610-01 CELL-DYN® Micro-Pipettes, 40 FL 100/pkg.

99620-01 CELL-DYN® Printout Tickets - TP250 1000/pkg.

30005-01 Graphic Printer Paper, (8-1/2 x 11) 2600/pkg.

91282-01 Eaton TP250 Ticket Printer Ribbon 1

93400-01 Epson FX85 Graphic Printer Ribbon 1

13401-01 Okidata 320 Graphics Ribbon 1

93410-01 Fujitsu DX2100 Graphics Ribbon 1

13411-01 Citizen MSP-40 Graphics Ribbon 1

13412-01 Citizen 120-D Graphics Ribbon 1

99660-01 DYN-A-WIPES Lint-Free Wipes 125/pkg.

98661-01 DYN-A-WIPES Lint-Free Wipes 40 boxes/case

99605-01 CELL-DYN® Sample Vials 500/pkg.

99606-01 CELL-DYN® Sample Vials 3000/pkg.

xii CELL-DYN® 1600 Operator's Manual


CELL-DYN Parts & Accessories


54305-01 Aperture Brush 1

91125-01 Dura Clamps 2

93040-01 Fan Filter (Large) 2

14850-01 Graduated Cylinder 2

91485-01 Peristaltic Pump Tubing (Medium) 4/pkg.

93009-01 Peristaltic Pump Tubing/CS Cap Piercer 1

93501-01 Power Cord 1

93164-01 Sample Probe - 1600 1

28541-01 Syringe, 10 mL, Diluent 1

91012-01 Teal Line Filter 1

* Assy, detergent, cap 1

* Assy, diluent, cap 1

* Assy, Lyse Cap (1 Liter) 1

* Assy, Lyse Cap (4 liter) 1

91072-01 Reagent Line Kit, dil, det, lyse 1

* Waste Cap Assy 1

92352-01 Operator's Manual 1

93140-01 System Disk, CELL-DYN 1600 1

92274-01 WBC Transducer 1

92264-01 RBC Transducer 1

* Interface Cable 1

* Fuse SB 5.0 amps 1

* Fuse SB 2.5 amps 1

25903-01 O-Ring/Probe Wash 2

* Latex Particles 3.31 DIA 1

* Latex Particles 5.0 DIA 1

*To place an order for products that do not have a List Number, contact the Customer Service Center in Santa Clara at 1-800-933-5535.

To place an order for products that have a List Number, contact the Customer Service Center in Chicago at1-800-323-9100.

If you require technical assistance on your CELL-DYN instrument, contact the Customer Support Center at1-800-CELLDYN.

Chapter 1 System Description

CELL-DYN® 1600 Operator's Manual 1-19140214 Rev E — February 1994

System Description

Introduction The CELL-DYN® 1600 is a multi-parameter hematology analyzer designed for invitro diagnostic use in clinical laboratories. The instrument has two versions, theCELL-DYN 1600, which accepts specimens from open collection tubes only, andthe CELL-DYN 1600CS, which accepts specimens in either open or closedcollection tubes.

The CELL-DYN 1600CS is equipped with an attached closed sample aspirationmodule referred to as the closed sampler. The closed sampler aspirates blood from aclosed collection tube that has been inserted in the sampler module. Operating andmaintenance instructions for the CELL-DYN 1600CS are described in theAddendum for the CELL-DYN 1600CS operation.

Intended Use The CELL-DYN 1600 generates the following measurements on EDTAanticoagulated 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 datamodule.

System Description Chapter 1

1-2 CELL-DYN® 1600 Operator's Manual

9140214 Rev E — February 1994

Figure 1-1 Front Panel View

Specimen Analyzer

The Specimen Analyzer section contains the hardware to aspirate, dilute, andanalyze each whole blood specimen.

Data Module The Data Module section includes the computer, video display monitor, membranekeypad, disk drive, and printer. The disk drive is described in the Right Panel sectionof 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.

Upper Front Cover

The Upper Front Cover protects the upper flow panel. A green grounding wireprovides electrical continuity for shielding purposes. Access to the upper flow panelis necessary to completely view the operation of the upper flow panel componentsand to perform certain maintenance operations.

Lower Front Cover

The Lower Front Cover protects the lower section of the flow panel. Access to thelower flow panel is necessary to view the action of the lower flow panel componentsand to perform certain maintenance procedures.



Sample Aspiration Probe

The Sample Aspiration Probe is used to aspirate whole blood from an openedcollection tube or from a sampling cup in the CELL-DYN 1600CS. After eachaspiration, waste liquid on the outside of the probe is removed as the probe is drawnthrough 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, andmembrane keypad. CELL-DYN 1600 operations are controlled by high-speedmicroprocessors that monitor system status, perform the various analytical routinesused by the instrument, perform diagnostic checks, and store result data.

Serial data (ASCII format) may be transferred to an external computer through anRS232 connector on the back panel. Data transmission may be done eitherautomatically as samples are processed or by command of the operator. Parallel datamay be output to an on-line printer.

Data Storage Results are stored on the disk drive for the most recent 320 cycles. No graphic dataare 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 alphanumericand 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 bythe screen label currently displayed directly above it.

A numeric and special function keypad is located directly below the row of eightunlabeled keys. Each key generates an audible tone when pressed. This membranekeypad contains the following numeric and special function keys:

� Numeric Keys — a block of ten numeric keys, labeled from 0 to 9, and adecimal key which are used to enter numeric data




Figure 1-2 Flow Panel

� ENTER Key — stores entered numeric data and advances the cursor to thenext entry location

� Asterisk (*) Key — allows the operator to escape (abort) data entry before itis completed

� Arrow Keys — a set of four keys used to move the cursor in the directiondepicted 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 functionaldescription of each component follows.

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 ofoptical detectors, one upper and one lower, mounted on it. It is used to meter a fixedvolume of the RBC/PLT dilution during the RBC/PLT measurement portion of eachcycle.

RBC/PLT Transducer Assembly

The RBC/PLT Transducer Assembly contains the fluidics and hardware required foraccurate measurement of the diluted red blood cells and platelets. The primarycomponents of this assembly are:



� The RBC/PLT Transducer — The transducer contains two chambers. Themixing chamber on the left is used to mix the RBC/PLT dilution. Thecounting chamber on the right contains the von Behrens plate used to preventcells 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 locatedin each transducer chamber. The electrodes conduct a constant current flowthrough the aperture during the RBC/PLT measurement portion of eachcycle.

� RBC/PLT Aperture Plate — This plate is inserted into a slot between the twotransducer chambers. A jewel containing the aperture is heat embedded intothe plate.

WBC Metering Assembly

The WBC Metering Assembly contains a precision-bore glass tube with a set ofoptical detectors, one upper and one lower, mounted on it. It is used to meter a fixedvolume 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 foraccurate measurement of the diluted white blood cells. The primary components ofthis assembly are:

� WBC Transducer — The transducer contains two chambers. The mixingchamber on the left is used to mix the WBC/HGB dilution. The countingchamber on the right contains the von Behrens plate used to prevent cells thathave 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 locatedin each transducer chamber. The electrodes conduct a constant current flowthrough the aperture during the WBC measurement portion of each cycle.

� WBC Aperture Plate — This plate is inserted into a slot between the twotransducer chambers. A jewel containing the aperture is heat embedded intothe plate.




Figure 1-3 Lower Left Side Panel Components

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 Figure1-3. The functional description of each component follows.

Waste Sensor Connector

The waste-full sensor plug connects to the Waste Sensor Connector port. When theelectrical sensor is tripped, the <WASTE FULL> message is generated and theREADY status is inhibited until the situation is corrected. The analyzer interprets adisconnected plug the same way as a full waste container. Therefore, if the waste isrouted 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 itsassociated cap, weighted end and label.



Diluent Inlet Tube Connector

This color-coded (red) port is used to connect the Diluent inlet tube with itsassociated 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 withits 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 drainingdown 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. Itcontrols the volume of lyse reagent dispensed during each cycle. It also prevents thedrainage 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 themixing chambers.

Sample Syringe - aspirates a specific volume of sample.




Figure 1-4 Rear Panel Components

Figure 1-5 Upper Right Side Panel

Rear Panel The components visible on the Rear Panel of the analyzer are depicted inFigure 1-4. The functional description of each component follows.

Fans Air intake fans cool the internal components of the analyzer. They are covered withfilters 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 depictedin Figure 1-5. The functional description of each component follows.

Chapter 1Chapter 1 System DescriptionSystem Description

CELL-DYN® 1600 Operator's Manual 1-1-999140214 Rev F — April 1996

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 ControlThis 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 thataccepts serial data in ASCII format.

Parallel Interface Connector

This port is used to connect the 25-pin printer cable from the graphics printersupplied with the analyzer.

Ticket Printer Connector

This port is used to connect the 25-pin printer cable when the printer is used toprint data in a ticket format.

Reagent System

Introduction The Reagent System is formulated specifically for the CELL-DYN 1600 seriesinstrument flow systems in order to provide optimal system performance. Use ofreagents other than those specified in this manual is not recommended asinstrument performance can be affected. Each CELL-DYN 1600 series system istested at the factory using the specified reagents, and all performance claims aregenerated using these reagents.

Reagents must be stored at room temperature to ensure optimal performance. Allreagents should be protected from direct sunlight, extreme heat and freezingduring storage. Temperatures below 32oF (0oC) may cause reagent layering thatchanges the tonicity and conductivity of the reagents. If any reagent has beenfrozen, it should not be used.

CAUTION When a reagent is changed, a normal background should be run to ensure that thesystem is primed immediately prior to running any specimens.

System DescriptionSystem Description Chapter 1Chapter 1

1-1-1010 CELL-DYN® 1600 Operator's Manual

9140214 Rev F — April 1996

The reagent inlet tubes have a cap attached that minimizes evaporation andcontamination 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 granulesthat may be present

• Convert hemoglobin to a modified hemiglobincyanide complex that ismeasurable at 540 nm (The quaternary ammonium lysate participates asa chromagen)

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

• Provide an optically clear solution that is needed to obtain the zeroreference during the Hemoglobin measurement cycle

• Provide proper meniscus formation in both metering tubes and maintainit during each run cycle

• Rinse both counting chambers, both metering tubes and the HGB flowcell with minimal bubble formation

Enzymatic Cleaner

CELL-DYN Enzymatic Cleaner is formulated to effectively remove proteinbuild-up within the instrument.

��

CELL-DYN® 1600 Operator's Manual 2-19140214 Rev D— June 1993

Installation

Introduction Installation of the CELL-DYN® 1600 should be performed by an Abbott authorizedrepresentative to ensure that all system components are functioning correctly and toverify system performance. Installation procedures must be repeated if the analyzeris moved from the original installation site.

NOTE Installation of the analyzer by an unauthorized or untrained person could result indamage to the system and may void the warranty. Never attempt to install the systemwithout an Abbott authorized representative present.

The remainder of this chapter gives general requirements for a successfulinstallation. The installation procedures for the Closed Sampler are contained in theCELL-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. Allowsufficient space on the countertop, or below the instrument, for Diluent, Lyse, andDetergent. Provide space below the instrument for the waste container (if one isused).

Allow two (2) to four (4) inches of space behind and on the left side of the analyzerfor air flow. A constant circulating internal air stream is required to cool circuitryand components whenever the power is��. If possible, allow 24 inches of spaceabove 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.

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9140214 Rev D— June 1993

Waste Requirements Allow room for a suitable waste container below the unit, or position the instrumentto permit the waste to be routed directly to a drain. The drain must be suitable fordisposal of waste with possible biological and chemical hazard. Be sure that thewaste outlet tube is secured in the drain hole. (Refer to Tube Installation forinstallation instructions.)

Power Requirements Be sure that the system is located at the desired site before attempting anyconnections. A grounded power outlet is required. A voltage regulator may benecessary for optimum performance. Insert the power cord into the power cordconnector on the rear panel. Do not turn the power ��

ATTENTION Check all side and rear panel connectors for particles or foreign material that canimpair electrical contact when connections are made.

��

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�� !��

�"" #"��"��$ %"&'

�"" #"��"��$ ("&'

��% �"%��%��$ ("&'

�% �#%�)%��$ %"&'

)" �"�%"��$ %"&'

The CELL-DYN 1600 is designed for low power consumption. The instrumentautomatically performs an initialization cycle whenever power is turned ��Duringthe daily routine operating period, power should be left ��.

��


��CELL-DYN 1600 Interface Panel (Right Side)

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 powerswitch is in the �** position. The printer manuals should be stored in a convenientlocation.

NOTE If the printer(s) is placed on top of the instrument, be sure that the paper does notrestrict air flow to the rear analyzer fans.

When used with the CELL-DYN 1600, the graphics printer prints graphic reportsand the ticket printer prints individual preprinted tickets. Depending on the outputdesired, one or both printers may be connected to the analyzer.

Follow installation instructions carefully to be sure that the printer(s) is connected tothe correct port on the analyzer. For convenience, general instructions are providedfor loading individual pre-printed tickets in the ticket printer. For a detaileddescription of the printer components and operating instructions, refer to the manualsthat accompany the printer(s).

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

2. Make sure that the printer power switch is �**. Plug the power cord into theprinter. Do not plug the other end into a grounded outlet until you are readyto power ��.

3. Locate the ribbon cable in the accessory kit and attach it to the connectorlabeled ��+��,�� (See Figure 2-1.) Attach the cable's other end tothe printer's rear panel connector. Refer to the printer's operation manual fordetailed installation procedures.

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9140214 Rev D— June 1993

4. Install the ribbon cartridge as directed in the printer manual.

5. Load the paper as directed in the printer manual.

6. Plug the power cord into a grounded outlet and turn the power switch ��.

Self-Test Printouts Run self-test printouts before using the printer for the first time. These self-tests maybe run any time to verify proper printer operation.

NOTE The CELL-DYN 1600 software automatically controls and adjusts most printconditions for the graphics printer, including page width. Occasionally, a fewsettings may need to be changed in the printer's software for correct operation. Ifprinting is not what you expect, refer to the printer manual for guidance in makingadjustments. If you have additional questions or experience any problems, call theAbbott 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 ticketis properly positioned prior to clamping.

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

2. Make sure that the printer power switch is �**. Plug the power cord into theprinter. Do not plug the other end into a grounded outlet until you are readyto print.

3. Attach the cable for the ticket printer to the connector labeled �+ -.�

�+��.� which is just below the $�$��.��+��.�*$ . on the analyzer.(See Figure 2-1.) Attach the cable's other end to the printer's rear panelconnector. 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 printheaddrive mechanism.

Self-Test Printouts Plug the power cord into a grounded outlet and turn the toggle switch ��. Insert aticket into the guide. A self-test mode checks operation and prints self-test data at thecompletion of the check.

��


��Lower Left Side Panel

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.

3. Attach the non-weighted end of the tube with the Red Diluent label to theRed side panel connector. Wipe the outside of the tube with a damp lint-freetissue and place the weighted end into the container ofCELL-DYN Diff-Screen Diluent. Secure the cap. Place the container on thesame level or lower than the unit.

4. Attach the non-weighted end of the tube with the Green Detergent label tothe Green side panel connector. Wipe the outside of the tube with a damplint-free tissue and place the weighted end into the container of CELL-DYNDiff-Screen Detergent. Secure the cap. Place the container on the same levelor lower than the unit.

5. Attach the non-weighted end of tube with the Blue Lyse label to the Blueside panel connector. Wipe the outside of the tube with a damp lint-freetissue and place the weighted end into the container of CELL-DYNDiff-Screen Lyse. Secure the cap. Place the container on the same level orlower than unit.

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9140214 Rev D— June 1993

6. Attach the Waste Outlet Tube to the Black side panel connector. Place end ofthe tube with the cap and sensor into the waste collection container. Securethe cap. Or, remove the cap from the tube and place the tube into a drainsuitable for collection of waste with possible biological and chemicalhazard. Be sure that the tube is secured to the drain hole.

Locate the Waste Full Sensor plug attached to the cap's electrode wires.Insert the plug into the /$��. connector located on the left panel. Whenthe waste tube is placed directly into a drain, insert a "dummy" plug into the/$��. connector. If a "dummy" plug is not inserted, the /$��.�*0��alert is activated.

Normally Closed Valves

The tubes for the normally closed valves on the left panel were removed from thevalves for shipment.

1. Locate the lower normally closed valve (black octagon), just above the LysePump Assembly, and the diluent inlet tube. Carefully stretch the tubebetween your hands and insert it into the valve opening. Work the tube gentlyback and forth until it is completely inserted into the valve.

2. Locate the upper normally closed valve (black octagon) above the diluentvalve and the detergent inlet tube. Carefully stretch the tube between yourhands and insert it into the valve opening. Work the tube gently back andforth 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 tubestops on both sides of rotor. The tube stops prevent the lyse tube frommoving during lyse pump rotor action.

2. Press down on the tube holder at portion closest to the front panel. (Refer toFigure 2-2.) Hold the tube holder down and insert the lyse tube under therotor and into the tube stops — confirm that tube is not crimped or pinched.Release the tube holder.

��


��Diluent Syringe

Diluent Syringe Installation

Before shipment, the diluent syringe is removed, cleaned and reinstalled in thedispenser. It is not attached at the luer lock fitting of the 3-way directional valve. Aprotective cap is attached to the luer lock fitting.

1. Slide the plastic cover onthe left side panel towardsthe rear to gain access tothe diluent syringe.

2. Remove the thumb nuts onthe syringe holder blockand remove the frontsection of the holderblock. Save the thumb nutsand the block.

3. Locate and unscrew theprotective cap attached tothe luer lock fitting forshipment.

4. Extend the barrel of thesyringe until it touches theluer lock fitting. Securethe syringe onto the luer lock fitting by turning it counterclockwise (asviewed from above) until it is finger tight — do not overtighten.

5. Replace the front section of the syringe holder block and secure it with thetwo (2) thumb nuts removed in step 2 above. Tighten the thumb nuts fingertight only.

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9140214 Rev D— June 1993

��Upper and Lower Front Cover Removal

Flow Panel Inspection and Installation

Upper Front Cover Removal

The upper front cover must be removed to gain access to the flow panel normallyclosed valve. The diluent tube, normally inserted in this valve, was removed forshipment. To ensure correct system operation, this tube must be completely insertedbefore the power is turned on.

1. Locate, on the lower edge of the upper front cover, the screw used to securelyattach the cover during shipment. Remove the screw and save it. The screwmust 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 connectorattached to analyzer's main frame. Remove the cover.

NOTE Performance may be affected if the ground wire is not reconnected before cover isreinstalled.

��


��

Lower Cover Removal

1. Locate the thumb screw on upper left side of lower front cover; turn itcounterclockwise 2 to 3 turns to loosen it. Slide the cover to your left about 1inch until the right side is free of the screen bezel cover and remove thethumb screw.

2. Raise the cover about 1 inch to release the bottom edge from the lower mountbrackets.

3. Pull cover out and set it aside.

Flow Panel Inspection

ATTENTION The diluent tube MUST be installed before the power is turned �� for the analyzerto operate correctly.

1. Locate, on the upper left portion of the flow panel, the normally closed (blackoctagon) valve, and the removed diluent tube. See Figure 2-5.

2. Carefully insert the diluent tube into the valve opening. Work the tube gentlyback and forth until it is completely inserted into the valve. Unless this tubeis securely seated, the message �� !" may be displayed andthe 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, alltubes, connectors, valves, etc. for damage.

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9140214 Rev D— June 1993

Data Diskette Installation

1. Locate the two 3.5" diskettes taped to the inside of the left side panelcompartment.

2. Remove the protective cardboard in the floppy disk drive. Save thecardboard insert and spare diskette.

3. Position the diskette so that the metal edge is inserted first and the diskettelabel is up and readable. Insert the diskette into the drive on the side of theinstrument

Power On The CELL-DYN 1600 is designed for low power consumption. Whenever the poweris applied, an initialization cycle is performed to check system status, to placemechanical components in the "home" position, and when acceptable, to place theunit in an initialized state.

Power On and Initialization

1. Confirm that the power plugs for the analyzer and the printer(s) are insertedinto the line voltage regulator or a grounded power outlet.

2. Move the printer's power switch to ��. Confirm that the graphic printerpaper is installed and feeding correctly.

3. Move the analyzer's power switch to ��. The screen illuminates within 15 to30 seconds and the statement ��#��#�$�%" appears inthe upper center screen System Status box. When the cycle is complete, themessage +�+�+$�+1.2 displays in the Status Box.

At initial installation, before activating an Auto-Startup cycle, allow the analyzer towarm up for 5 minutes. System setup can be performed at this time.

NOTE An Auto-Startup cycle actuates whenever the &'��(�key is pressed and+�+�+$�+1.2 or ��$�234 appears in the System Status box. Each Auto-Startupcycle 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 the5$+��5.�0 is displayed. At the completion of each Power On Initialization cycle,the 5$+��5.�0 is displayed with the cursor flashing at the 6� .�$��+2>field.

��


Enter the two digit identification number using the numeric keys on the keypadbelow the screen. The Operator ID can be entered ONLY when the 5$+��5.�0 isdisplayed.

NOTE An Operator ID is not required for system operation.

The Sequence Number

The Sequence Number display below the 6� .�$��+27 field automaticallyincrements by one each time a Run cycle is actuated by pressing the touch plate. Thesequence number cannot be entered or changed by the operator.

Setup System Operation

The �.�0 �5.�0 is used to review and change options for data format to outputdevices such as printers and computers. The units of measure display and printformat options are also selected from this screen.

�� The function is active.�** The function is not active.

Any number displayed in place of �� or �** can be changed using the numerickeys on the keypad to enter a new number within the stated limits. For example, thenumber preceding the "line-feeds per printer page" statement applies to the graphicprinter and indicates the current line-feed selection.

Installation Chapter 2


9140214 Rev DC June 1993

Main SETUP MENU Screen

The numbers on the main SETUP MENU screen shown below correspond to thefollowing numbered options:

Table 2-2Main 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 thenext sample, unless a new ID number is entered.

3. Print Histograms — When this option is enabled, the WBC, RBC, and PLThistograms are printed with each specimen report.

4. Print MPV, PCT, PDW — When this option is enabled, the MPV, PCT, andPDW results are printed with each specimen report.

NOTE Clinical significance has not been established for PCT and PDW; therefore, they arenot reportable.

��


5. Print ALERTED LYM/%L, *MID/%M, GRAN/%G Results — When thisoption is enabled, the results for these flagged parameters are printed on thespecimen report.

6. Print ALERTED PLT Results — When this option is enabled, the results fora flagged PLT are printed on the specimen report.

7. Automatic Ticket Printout — When this option is enabled, a specimen reportis automatically printed on the ticket printer.

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

9. Line-Feeds per Form-Feed on Graphics Printer (01 to 99) — When theentered number is 66, one report is printed per 8.5" by 11" sheet of paper. Toprint two reports per sheet of paper, enter 33 and align the paper in the printerso that the top edge is even with the ribbon.

10. Automatic Transmission to Computer — When this option is enabled, thespecimen report is automatically transmitted to a host computer.

11. Automatic Transmission of Histograms — When this option is enabled, theWBC, RBC, and PLT histograms are automatically transmitted to a hostcomputer.

12. Transmission Time-Out (0.1 to 9.9 Seconds) — This option sets the amountof time (in seconds) the analyzer will attempt to send a report. If thetransmission fails, the analyzer will “time-out.”

13. Units of Measure — This option sets the appropriate units of measure for theresults on the specimen report.

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9140214 Rev D— June 1993

To Review or Change Setup Status

1. At the 5$+��5.�0, press &)�� (. The �.�0 �5.�0�8��!�.

Review and/or change any selection on the �.�0 �5.�0 screen.

2. ARE THE SELECTIONS ACCEPTABLE?

YES Go to the Date/Time Setup procedure.

NO Use the #��* keys on the keypad to move the cursor to theselection requiring change.

Press �� to toggle between ��or��**�

OR

Type the new number that is within the limits shown for theselection. Repeat this process until all required changes arecomplete. 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 dateand time display in the upper right of the screen. The multiple date format optionallows the operator to select the desired date format.

� Date re-entry is not required when a new format option is selected and thecurrent date is correct.

� The hour clock cannot differentiate between AM and PM. To avoidconfusion, use a 24-hour clock. (For example, 1 for 1 AM and 24 for 12midnight.)

Change the Date and Time

1. From the �.�0 �5.�0, press &�#��+��(.The �.�0 �2$�.9�+5.�5.�0 displays.

2. IS THE DISPLAYED DATE FORMAT CORRECT?

YES Go to step 3.

NO Type the number for the desired date format option.Go to step 3.

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3. IS THE DISPLAYED DATE AND/OR TIME CORRECT?

YES Press &'��'�( to return to the��.�0 �5.�0.

The date entry is not required when the date is correct and onlythe format requires change.

NO Enter the date (using MM/DD/YY) and/or the time (using a24-hour clock).

Repeat the process until all required changes are complete.

NOTE A slash and/or colon must be entered when setting the date or time.

4. Press &'��'�( to return to the �.�0 �5.�0.

Patient Range Entry Key

Upper and lower alert limits for patient specimen results can be entered, reviewed,and changed as required via the & #��'#�%��'!( key. Entered values areused to flag patient specimen results for each of the 18 parameters.

When a parameter result exceeds an entered limit, each affected result displays ininverse 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 orprinted Data Log summary page.

To Change Patient Range Entries

1. At the �.�0 �5.�0 press & #��'#�%��'!(.The $�+.��$�:.�.��4 screen displays.

2. ARE THE LIMITS ACCEPTABLE?

YES Press &'��'�( to return to the��.�0 �5.�0.

NO Use the #��* keys to move the cursor to the numbers that are tobe 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 valueentered contains the maximum number of digits for the field. Ifthe number contains less than the maximum number of digits,press �� to move the cursor to the next field.

Press &'��'�( to return to the �.�0 �5.�0.

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9140214 Rev D— June 1993

Reagents Log Key &'�#%��)��,%( displays a new screen and labels allowing the operator to selecta specific reagent type: diluent, detergent, or lyse. Additional screens and labelsallow the operator to enter, review or print: container size, lot number, expirationdate, and open date for up to ten containers per reagent.

To Complete the Reagents Log

1. At the �.�0 �5.�0, press &'�#%��)��,%(.The �.�. ��.$:.�� screen displays.

2. Select a Reagent Log by pressing the appropriate keypad:

&��(, &�!)�(, or &��'%��(

The selected log screen displays with the cursor positioned on the first blankline of the log.

3. Enter the Size, Lot#, Expiration Date, and Open Date. This screen onlyaccepts numbers in the fields on the screen.

Repeat this process until all entries for the reagent log are complete. If thevalue entered into a field contains less than the maximum number of digitsallowed for the field, press ��. The cursor moves to the next field.

4. Press & '��( to print the log.

5. Press &'��'�(.Repeat steps 2-4 for each reagent type.

OR

To return to the �.�0 �5.�0, press &'��'�(, and then &)�� (.

Control File Setup Key

The Control File Setup function allows the operator to select a specific control file toenter, review, change, or print numeric data pertaining to selected file(s), e.g., lotnumber, expiration date, printed insert mean and limits, etc. Any run resultexceeding these entered limits is displayed in inverse video and underlined on thegraphic printout. The information is printed with an "*" on the ticket printer.

��


To Select a Specific Control File

1. At the �.�0 �5.�0, press &��)�� (The message � '�))�),��-�!" displays in the Status Box.

2. Press the corresponding key for the type of control to be updated: &�,.��,��',�(, &�,'�#��,��',�(, or &/%/��,��',�(.The ��*+�.��.�0 screen displays.

3. IS THE LOT NUMBER ENTRY ACCEPTABLE?

YES Press ��.Go to step 4.

NO Enter the lot number (up to nine digits) and press ��.The data is stored and the cursor advances to the next field.

This field accepts only numeric data. If the lot number is less thannine digits, press �� to advance the cursor.

4. IS THE EXPIRATION DATE ENTRY ACCEPTABLE?

YES Press ��0Go to step 5.

NO Type the expiration date (using MM/DD/YY) from the controlvial or assay sheet.

5. IS THE WESTGARD RULE SELECTION ACCEPTABLE?

YES Go to step 6.

NO Set the cursor at the rule requiring change, and press ��.

Repeat this process until all rule selections are acceptable.Go to step 6.

6. REVIEW RANGE OR MEAN/LIMITS?

YES Press &'#�%�( or &��#�+��)(. The screen for the selectedcontrol file displays.

Go to step 7.

NO Press &'��'�( to return to ��*+�.��.�0 �5.�0.

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9140214 Rev D— June 1993

7. ARE THE VALUES ACCEPTABLE?

YES Go to step 8.

NO Use the #��* keys to move the cursor to the first value to bechanged and type the new value.

If the value has less than three digits, press the �� key to storethe data and advance the cursor.

Repeat this process until all values are entered and acceptable.Go to step 8.

8. IS A PRINTOUT REQUIRED?

YES Press & '��(.NO Go to step 9.

9. IS ANOTHER CONTROL SETUP REQUIRED?

YES Press &'��'�( twice to return to the *+�.��.�0 �5.�0.

Repeat steps 2-9 for each control as required.

NO Press &'��'�( twice.Press &)�� ( to return to �.�0 �5.�0 screen.

Replicate File Setup Key

Nine QC files, labeled 1 to 9, are designated for use with replicate "control"specimens, such as:

� retained patient specimens� overlapping control lots� different shift control specimens� different brand of controls� precision check specimens, etc.

Using &'� ��)�� (1 values for each parameter (up to 18), with mean/limits,or upper and lower range, can be entered for each file. In addition, data can becopied from a replicate file into a designated control file.

NOTE Prior to data copy, any run data in the designated control file must be purged using& �'%�( for that control.

��


To Enter Flag Information

1. At the��.�0 �5.�0, press &'� ��)�� (.The ��'�'� ��#��2" message displays in the Status Box.

2. Enter the replicate file number.The �. �+ $�.�;�;�*+�.��.�0 �screen displays.

3. IS THE LOT NUMBER ENTRY ACCEPTABLE?

YES Press ��.Go to step 4.

NO Type lot number, or other identifier, up to nine digits. Press�� to store data and advance the cursor.

NOTE This field accepts only numeric data. If the lot number is less than 9 digits, press�� to advance the cursor.

4. IS THE EXPIRATION DATE ENTRY ACCEPTABLE?

YES Press ��0Go to step 5.

NO Type the expiration date (using MM/DD/YY) from the controlvial or assay sheet.

5. IS THE WESTGARD RULE SELECTION ACCEPTABLE?

YES Go to step 6.

NO Set the cursor at the rule requiring change. Press ��.

Repeat this process until all rule selections are acceptable.Go to step 6.

6. REVIEW RANGE OR MEAN/LIMITS?

YES Press &'#�%�( or &��#�+��)( to display the screen for theselected control file.

Go to step 7.

NO Press &)�� ( to return to �.�0 �5.�0.

��


9140214 Rev D— June 1993


YES Go to step 8.

NO Use the #��* keys to move the cursor to the first value to bechanged and type the new value.

If the value contains less than three digits, press the �� key tostore the data and advance the cursor.

Repeat this process until all values are entered and acceptable.Go to step 8.

NOTE Refer to the Quality Control chapter for the established Replicate Specimen MeanValues.

8. IS A PRINTOUT REQUIRED?

YES Press & '��(.

NO Go to step 9.

9. IS ANOTHER REPLICATE FILE REQUIRED?

YES Press &'��'�(.Repeat steps 2-9 for each file, as required.

NO Press &'��'�( then &)�� ( to return to �.�0 �5.�0screen.

��


X-B File Setup Key Calculated data for each batch (20 specimens) is compared to an established X-Btarget and limits to determine if the X-B batch data is acceptable. To eliminate biasfrom grossly abnormal specimen results, data acceptance limits are set, via the <�3

*+�.��.�0 screen, to automatically exclude these specimens from the program.

To Use the X-B Function

1. At the �.�0 �5.�0, press &3�4�)�� (.

The <�3�*+�.��.�0 screen displays, and the cursor is on the first MCVlimit.


YES Press &)�� ( to return to �.�0 �5.�0 screen.

NO Move the cursor to the first value to be changed and type the newvalue.

If the value contains less than 3 digits, press the �� key tostore the data and advance the cursor.

Repeat this process until all values are entered and acceptable.

3. Press &)�� ( to return to �.�0 �5.�0 screen.

Auto-Startup Cycle

The Auto-Startup cycle activates anytime the &'��( key is pressed and either+�+�+$�+1.2 or ��$�234 displays in the Status Box. The cycle is designed toprime the flow system and check the background before specimens are run. Uponcompletion of the cycle, the �0� screen displays with the background check results.A background is run in order to monitor the quantity of particles present in reagentsand the flow system.

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9140214 Rev D— June 1993

At installation, perform multiple run cycles to thoroughly prime and purge anyparticles from the flow system. During each cycle, the computer monitors the timerequired for each measurement, referred to as the count time. A value for this timedisplays in seconds to the right of the histograms. The count time is used to monitorfluid flow, to detect the presence of partial restrictions in either aperture and/or thepresence of air in either metering tube. Cell sizing can be affected by either of theseconditions.

To Actuate the Auto-Startup Cycle

The message ��#��1��#�$��" must be displayed in the Status Boxof the 5$+��5.�0 screen.

1. To start the cycle, press &'��].

2. The message �'��1�'�#�!"�displays in the Status Box when thecycle is complete.

3. Press &) ��! �( to display the next screen.

4. Press &�,'�#��4#�-%',��(. The 5$+��0��5.�0 displays.

5. Press the touch plate to start the cycle - no specimen is required.

6. Repeat step 5 until acceptable background and count time data (seeTable 2-3) are obtained for three consecutive cycles.

��)

$��3��=��8��8� ��2��

3��=��8 ��

/3 �""�%�-90� %�""�>��""��

�3 �"�"%�590� ?�""�>��""��

&:3 �""��98�

�� "�"��-90�

This completes initial installation power on, system setup, and initial primeprocedures. Calibration is the next procedure when installing an analyzer.

Chapter 3 Principles of Operation

CELL-DYN® 1600 Operator's Manual 3-19140214 Rev E—February 1994

Principles of Operation

Introduction The principles that the CELL-DYN® 1600 uses to measure, count, and calculate thehematologic parameters are discussed generally in the first section of this chapter. Theparameters are discussed individually and a detailed explanation of the theory used forparameter 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 themeasurements for each parameter are performed.

Sample Analysis Cycle Overview

Aspiration The CELL-DYN 1600 uses the open sampler mode to aspirate 30 microliters ofwhole blood from a collection tube that has been opened and held under thespecimen 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 samplein the Pre-Dilute mode (40 )L of sample to 10 mL of diluent).

The diluted sample is then divided into two samples.

� 100 microliters of the 1:251 sample dilution are aspirated and mixed with anaddition of 5 mL of diluent in the RBC/PLT dilution bath to a ratio of1:12801. The 1:12801 dilution is used to analyze the red cell and the plateletparameters.

� The remainder of the 1:251 dilution is mixed with 1.0 (± 0.25) mL of lysereagent in the WBC dilution bath. The lyse reagent changes the membrane ofeach red cell causing cytoplasm and hemoglobin to be quickly released. Thered cell membrane (ghost) that remains is less than 2 femtoliters.

Principles of Operation Chapter 3


9140214 Rev E—February 1994

� The lyse reagent also compresses the membrane of each white cell(leukocyte). This causes cytoplasm to slowly diffuse from the cell as themembrane shrinks around the nucleus and any cytoplasmic granules that maybe present. This dilution is used to measure the number and modified size ofthe white cells and the amount of hemoglobin released.

� Volumetric metering is used in both the WBC dilution bath and the RBCdilution bath to ensure that a precise amount of diluted specimen is measuredduring each count cycle.

WBC Analysis Electrical impedance is used to count the white blood cells as they pass through theaperture in the WBC transducer. As each cell is drawn through the aperture, achange in electrical resistance occurs generating an equivalent voltage pulse. Thenumber of pulses sensed during each cycle corresponds to the number of white cellscounted. The amplitude of each pulse is directly proportional to the volume of thecell it represents.

The CELL-DYN 1600 uses electronic sizing to determine three distinct white cellsubpopulations. Cells correlating to lymphocytes are included in the small cellsubpopulation. Cells correlating to granulocytes are included in the large cellpopulation. The remaining cells correlating to monocytes, eosinophils, basophils,blasts, and other precursor white cells are generally included in the mid-size cellpopulation.

RBC/PLT Analysis

The 1:12801 dilution is pulled through the aperture of the transducer bath whereelectrical impedance is used to count the red blood cells and platelets as they passthrough the aperture.

Hemoglobin Analysis

After the WBCs have been counted and sized, the remainder of the lysed dilution istransferred to the HGB flow cell. In the flow cell, the CELL-DYN 1600 measuresthe ability of the dilution to absorb light at a wavelength of540 nm. The result is reported as a measured weight per volume of whole blood; forexample, HGB xx.x g/dL refers to xx.x grams of hemoglobin per deciliter of wholeblood.

Results Displayed All data are transferred to the CELL-DYN 1600 computer for processing. Results aredisplayed on the video display monitor RUN MENU. Size distribution data for lyse-modified WBCs and subpopulations, for RBCs and PLTs are displayed ashistograms. The corresponding results from each count are displayed to the left ofeach histogram.



MCV, HCT, RDW Determination

The CELL-DYN 1600 determines the mean cell volume (MCV) from the red cellsize distribution data and reports it in fL. The result for hematocrit is calculated fromthe 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 cellheterogeneity 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 plateletvolume (MPV). Each MPV xx.x fL result is reported directly in femtoliters. A resultfor plateletcrit is calculated from the platelet count and mean platelet volume asfollows:

PCT = (PLT * MPV) / 10

Each PCT x.xx mL/L result is reported as milliliters per liter. Platelet distributionwidth (PDW) is the geometric standard deviation (GSD) of the platelet sizedistribution. Each PDW xx.x 10(GSD) result is derived from the platelet histogramdata and is reported as 10(GSD).

MCH and MCHC Determination

Values for the mean cell hemoglobin (MCH) and the mean cell hemoglobinconcentration (MCHC) are calculated automatically whenever appropriateparameters are measured, e.g., red cell count, hematocrit, and hemoglobin. Thefollowing 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 isreported 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 externallywith 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 arecounted 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 isbased on the measurement of changes in electrical resistance produced by a particlesuspended in a conductive diluent as it passes through an aperture of knowndimensions. An electrode is submerged in the liquid on both sides of the aperture tocreate an electrical pathway.

As each particle passes through the aperture, a transitory change in the resistancebetween the electrodes is produced. This change produces a measurable electricalpulse. The number of pulses generated is indicative of the number of particles thatpassed through the aperture. The amplitude of each pulse is essentially proportionalto the volume of each particle.

Each pulse is amplified and compared to internal reference voltage channels. Thesechannels are delineated by calibrated size discriminators to accept only pulses of acertain amplitude. Thus, the pulses are sorted into various size channels according totheir amplitude.

Volumetric Metering

An accurate cell count cannot be obtained unless the precise volume of dilutedwhole blood that passes through the aperture during the count cycle is known. The1

CELL-DYN 1600 uses the Volumetric Metering process to regulate the count cycleand 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 twooptical detectors. This tube ensures that a precise amount of diluted specimen ismeasured during each count cycle. The exact amount is determined by the distancebetween the two optical detectors.



Detergent is used to create a meniscus in the metering tube. The count portion of thecycle is initiated when the meniscus reaches the upper detector. The count cyclestops when the meniscus reaches the lower detector. The amount of time required forthe meniscus to travel from the upper detector to the lower detector is called theCount Time and is measured in seconds. This is displayed on the RUN MENU. Thecomputer 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 bubblesin the metering tube. If significant variation is detected, the RUN MENU displaysthe message <CLOG> or <FLOW ERROR>, and no WBC and differential data aredisplayed. A Clog indicates the flow was too slow, most likely caused by debris inthe aperture. Flow errors indicate the flow was too fast, often caused by bubbles inthe metering tube.

WBC Measurement

The 1:251 WBC/HGB dilution is delivered to the WBC dilution bath where it isbubble mixed with 1.0 (± 0.25) mL of lyse reagent. A metered volume of the lysedsample is drawn through the aperture by vacuum. The WBCs are counted byimpedance. If the pulse generated is above the WBC lower threshold, it is counted asa WBC.

The von Behrens plate located in the WBC transducer counting chamber minimizesthe effect of recirculating cells. As cells exit from the aperture, they tend to swirlaround and may re-enter the sensing zone and be counted a second time. This causesthe counts to be falsely elevated.

Coincidence Passage Correction

Two or more cells can enter the aperture sensing zone simultaneously during ameasurement cycle. The resistance change created in this situation generates a singlepulse with a high amplitude and increased pulse area. Thus, it appears that one largecell has passed through the aperture. Consequently, the cell count is falselydecreased. This count reduction, referred to as Coincidence Passage loss, isstatistically predictable because it has a direct relationship to the effective volume ofthe aperture and the amount of dilution. Each total cell count is automaticallycorrected for coincidence passage loss.

WBC Parameters

WBC Histograms The WBC data are plotted in a histogram format with the relative number of cells onthe Y axis and the WBC size distribution data on the X axis. Results of each countare displayed to the left of the histogram on the RUN MENU.




Once the WBC count is determined, the absolute number of cells in eachsubpopulation is calculated by multiplying that WBC count by the percentage. Theresults are expressed as follows:

� WBC # K / )L� LYM # K / )L and %� GRAN # K / )L and %� MID # K / )L and %

RBC/PLT Measurement Process

Overview The impedance method is used for the determination of RBC and PLT data. Cells arecounted 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. Thismethod is based on the measurement of changes in electrical resistance produced bya particle suspended in a conductive diluent as it passes through an aperture ofknown dimensions. An electrode is submerged in the liquid on both sides of theaperture to create an electrical pathway.

As each particle passes through the aperture, a transitory change in the resistancebetween the electrodes is produced. This change produces a measurable electricalpulse. The number of pulses generated is indicative of the number of particles thatpassed through the aperture. The amplitude of each pulse is essentially proportionalto the volume of each particle.

Each pulse is amplified and compared to internal reference voltage channels. Thesechannels are delineated by calibrated size discriminators to accept only pulses of acertain amplitude. Thus, the pulses are sorted into various size channels according totheir amplitude.

Coincidence Passage Correction

Two or more cells can enter the aperture sensing zone simultaneously during ameasurement cycle. The resistance change created in this situation generates a singlepulse with a high amplitude and increased pulse area. Thus, it appears that one largecell has passed through the aperture. Consequently, the cell count is falselydecreased. This count reduction, referred to as Coincidence Passage loss, isstatistically predictable because it has a direct relationship to the effective volume ofthe aperture and the amount of dilution. Each total cell count is automaticallycorrected for coincidence passage loss.



Volumetric Metering

An accurate cell count cannot be obtained unless the precise volume of dilutedwhole blood that passes through the aperture during the count cycle is known. The1

CELL-DYN 1600 uses the Volumetric Metering process to regulate the count cycleand 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 withtwo optical detectors. This tube ensures that a precise amount of diluted specimen ismeasured during each count cycle. The exact amount is determined by the distancebetween the two optical detectors.

Detergent is used to create a meniscus in the metering tube. The count portion of thecycle is initiated when the meniscus reaches the upper detector. The count cyclestops when the meniscus reaches the lower detector.

The amount of time required for the meniscus to travel from the upper detector to thelower detector is called the Count Time and is measured in seconds. This isdisplayed on the RUN MENU. The computer monitors the count time to detect anyvariation from the expected values. Variation may be caused by debris in theaperture, vacuum fluctuation or air bubbles in the metering tube. If significantvariation is detected, the RUN MENU displays the message <CLOG> or <FLOWERROR>, and no RBC/PLT and differential data are displayed. A Clog indicatesthe flow was too slow, most likely caused by debris in the aperture. Flow errorsindicate 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 itis bubble mixed. A precise volume of the diluted specimen is drawn through theaperture by vacuum. The RBCs and PLTs are counted by impedance. If the pulsegenerated is above the PLT lower threshold, it is counted as a PLT. If the pulsegenerated is above the RBC lower threshold, it is counted as an RBC.

The von Behrens plate located in the RBC/PLT transducer counting chamberminimizes the effect of recirculating cells. As cells exit from the aperture, they tendto 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 onthe Y axis and the RBC size distribution data on the X axis. Results of each countare displayed to the left of the histogram.

RBC Count The RBC count is measured directly. The number of RBCs is expressed as follows:

RBC = # M / )L

MCV The Mean Cell Volume is the average volume of the individual red blood cells. TheMCV 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 apercentage of the whole blood volume. The HCT is calculated from the red bloodcell 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 thered blood cell expressed as picograms. The MCH is calculated from the RBC andHGB as follows:

MCH = (HGB/RBC) * 10

MCHC The Mean Cell Hemoglobin Concentration is the ratio of the weight of hemoglobinto the volume of the average red blood cell expressed in percent. It is calculatedfrom the HGB and the HCT as follows:

MCHC = (HGB/HCT) * 100

RDW Red Cell Distribution Width is a measure of the heterogeneity of the RBCpopulation. 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 forRBC Flagging Information.



PLT Measurement

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

If no interference is detected, the lower and upper thresholds are set at 2 and35 fL, respectively. If interference is detected, the thresholds float to determine thebest separation between the interference and the PLT population. The lowerthreshold floats in the 1 - 3 fL region, and the upper threshold floats in the 15 - 35 fLregion. Once the thresholds have been determined, the PLT count is derived from thedata 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 itand the RBC lower threshold are re-evaluated. If the PLT upper threshold is less than35 fL, the count above it (but less than the RBC lower threshold) is added to theRBC count.

If the interference in either threshold region exceeds a predetermined limit, the PLTcount is flagged accordingly. The flags are discussed in the last section of thischapter.

PLT Parameters

PLT Histogram The PLT data are plotted in a histogram format with the relative number of cells onthe Y axis and the PLT size distribution data on the X axis. Results of each count aredisplayed to the left of the histogram.

PLT Count The Platelet Count is derived from the PLT histogram after the PLT data have beenanalyzed by the platelet algorithm. The PLT count is expressed as follows:

PLT = # K / )L

MPV The Mean Platelet Volume is derived from the PLT histogram after the PLT counthas been determined. The MPV is expressed in femtoliters.




PCT The Plateletcrit is the product of the PLT and MPV and is analogous to thehematocrit. 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 PLTflagging information.

Hemoglobin Measurement

Overview The modified cyanmethemoglobin method is used for the colorimetric determinationof hemoglobin. A sample of the lyse diluted sample from the WBC dilution bath isused for the HGB measurement. A low-energy LED is used as the light source. Afiltered 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 isreleased to a cyanide-containing pigment. After the WBC count is completed, thesample is transferred to the Hemoglobin flow cell where the hemoglobinconcentration is measured. The sample enters the flow cell from the bottom. Thisallows any bubbles present to exit the flow cell so they will not interfere with thereading.

The LED shines through the flow cell and a 540 nm narrow bandwidth filter onto aphotodetector. The hemoglobin concentration is directly proportional to theabsorbance of the sample at 540 nm. After the hemoglobin reading has been madethe HGB flow cell is rinsed with detergent.

The rinse is drained and more detergent is delivered to the flow cell. A zero or blankreading is then obtained on the detergent to provide a reference to which the samplesignal is compared.

The reference and sample readings are compared to determine the HGBconcentration of the sample. The HGB result is expressed in grams of hemoglobinper deciliter of whole blood.



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

Operational Messages and Data Flagging

Introduction Operational messages and data flags appear on the RUN MENU and on printedreports. The CELL-DYN 1600 monitors condition and data criteria that may affectthe displayed results, and these messages and flags are used to alert the operator.Instructions for interpreting all flags, numeric, and histogram data should beincorporated into the laboratory's procedure and used to determine the need forfurther action and/or review of results. Messages are divided into the followingcategories:

Instrument Messages:Fault ConditionsStatus Conditions

Parameter Flagging Messages:Dispersional Data AlertsSuspect Parameter MessagesSuspect 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 aninappropriate condition during specimen processing. When necessary, data aresuppressed. When any of these messages are displayed, refer to Chapter 10,Troubleshooting, for assistance. Follow the instructions given and take theappropriate 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 anexplanation) or taken from the instrument's preset linearity limits. If results for aparameter 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 placeof or next to the affected result(s). All RUN, DATA LOG, and QC results for theaffected 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 affectedmeasurement histogram. When the time for fluid to reach either detector istoo long, <CLOG> is displayed. When the time to reach either detector istoo short, <FLOW ERROR> is displayed.

Action: Press [CLEAR ORIFICE]. Rerun the specimen when the system isready. If <CLOG> appears again, follow the instructions in Chapter 9,Maintenance, to clean the transducers. If <FLOW ERROR> appearsagain, 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 aparticular parameter or group of parameters. The result may be suspect due tointerfering substances or the inability of the instrument to measure a particularparameter due to a sample abnormality. The name of each flag, the location of theflag on the display, the cause of the flag, and the action to be taken are given in thefollowing 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 flagmay be caused by:

Debris (dirty aperture)Contaminated reagentElectronic noiseMicrobubbles



Action: Check the background count. If it exceeds the limits, troubleshootaccordingly. If it is within limits, repeat the specimen. If the flagpersists, review a stained smear to determine the cause of theinterference 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 becaused by:

Microcytic RBCsSchistocytesGiant PlateletsSickle CellsPlatelet 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 thehistogram indicates an overlap (poor separation in the upperdiscriminator) in the RBC and PLT populations, review a stained smearto determine the cause and confirm the PLT count.

Suspect Population Flags

These flags are generated when the instrument's evaluation of the measured data fora particular parameter or group of parameters indicates the possible presence of anabnormal subpopulation. A stained smear should be reviewed whenever a suspectpopulation flag is present. Therefore, instructions for interpreting flags should beincorporated 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 RBCsPlatelet clumpsGiant PlateletsCryoglobulinsIncomplete lysis of red cells




Flag: LYM R1 or RM (Displays and prints after the percent [L%] result.)Cause: LYM data in the region to the right of 35 fL are outside the normal criteria. Action: Check the whole blood for clots or agglutination. Redraw and rerun the


LymphocytosisLymphopeniaCryoglobulins

Flag: LYM R2 or RM (Displays and prints after the percent [L%] result.)Cause: LYM data in the region to the left of 98 fL are outside the normal criteria.Action: Check the whole blood for clots or agglutination. Redraw and rerun the


LymphocytosisLymphopeniaBlasts/Plasma CellsVariant lymphocytesBasophilia

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 confirmresults. This flag may be caused by:

EosinophiliaBlast/Plasma CellsAgranular neutrophils Platelet clumps (occasionally)BasophiliaBands

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.



Action: Check the whole blood specimen for clots or agglutination. Redraw andrerun the specimen as required. Review a stained smear to confirm theresults. This flag may be caused by:

GranulocytosisDecreased lytic actionNeutropenia

Flag: WBC R4 (Displays to the right of the total WBC result.) Cause: Flag will be activated if the total WBC count is > 30K/)L and the mean

channel location is above 150 fL, or if the mean channel location exceeds287 fL.

Action: Check the whole blood specimen for clots or agglutination. Redraw andrerun the specimen as required. Review a stained smear to confirmresults. This flag may be caused by:

MonocytosisBasophiliaEosinophiliaBlast/Plasma cellsIncreased bandsGranulocytosisAgranular neutrophilsVariant (atypical) lymphocytesNeutropeniaPlatelet clumps (large)Abnormal lytic action

References 1. ICSH, The Assignment of Values to Fresh Blood used for CalibratingAutomated Cell Counters, Clinical and Laboratory Hematology 1988,10:203-212.

Chapter 4 S ystem Specifications


System SpecificationsCELL-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. Itprovides 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 beepindicator.

A numeric and special function keypad is located directly below the row of eightunlabeled keys. Each key generates an audible tone when pressed. This membranekeypad contains the following numeric and special function keys:

� Numeric Keys — a block of ten numeric keys, labeled from 0 to 9, which areused to enter numeric data

� ENTER Key — stores entered numeric data and advances the cursor to thenext entry location

System Specifications Chapter 4



� Asterisk (*) Key — allows the operator to escape (abort) data entry before itis completed

� Arrow Keys — a set of four keys used to move the cursor in the directiondepicted by each arrow

� Pound (#) Key — used for service functions only

Graphic Printer An external dot matrix printer provides alphanumeric and graphic reports fordisplayed 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: 15 C to 30 C (59 F to 86 F)0 0 0 0

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

Chapter 4 System Specifications


Aspiration Volumes (whole blood)

� Open Mode: 30 �L� Pre-Dilute Mode: 40 �L

Measurement Specifications

Measurement Channels

Two impedance channels, one for WBC impedance count and one for RBC and PLT.

WBC and Differential

� Method: Impedance with volumetric metering� Aperture Size: 100 �m in diameter x 60 �m in length� Dilution: One part whole blood in 250 parts diluent plus

1.0 ± 0.25 mL lyse reagent.

RBCs and PLTs� Method: Impedance with volumetric metering� Aperture Size: 60 �m in diameter x 70 �m in length� Dilution: One part whole blood in 12,800 parts of diluent.

HGB

� Method: Modified cyanmethemoglobin with autoblank� Light Source: LED� Wavelength: 540 nm� Dilution: One part whole blood in 250 parts diluent plus 1.0 ± 0.25

mL lyse reagent.

Performance Specifications

Linearity Linearity specifications were determined by analyzing dilutions of commercially available controlmaterial 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 theeffect of imprecision. The stated limits (see Table 4-4) were determined by regression analysisthrough the origin (0,0).




Table 4-4 Linearity Specifications

Parameter Linear Range Allowable Limit +/-

WBC* 1.0 - 99.9 K/�L +/- 0.4 or 3.0%

RBC 1.00 - 7.00 M/�L +/- 0.1 or 2.5%

HGB 2.5 - 24.0 g/dL +/- 0.3 or 2.0%

MCV 50 - 200 fL +/- 3.0 or 3.0%

HCT 10.0 - 70.0% +/- 1.0 or 2.5%

PLT 10 - 999 K/�L +/- 12 or 4.0%

*Linearity specification determined by use of commercially available control material.

AccuracyThe CELL-DYN 1600 system can be calibrated to agree with reference values within the allowablecalibration ranges. Both modes of operation, open and closed, may be calibrated. Thus, it is possibleto compensate for differences between modes due to differing aspiration pathways or operationalsequences. When each mode is properly calibrated according to directions given in this manual, biasbetween the modes is clinically insignificant.

Greater than 0.98 correlation was obtained to reference methods and/or comparison analyzer valuesfor WBC, RBC, HGB, PLT, MCV, and HCT. Greater than 0.92 correlation was obtained tocomparison analyzer values for RDW, MPV, LYM and GRAN. Greater than 0.60 correlation wasobtained 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 byreference methodology. Samples that are used for correlation studies should not display any suspectflags.

Precision"Within Sample" precision checks routine instrument operation. It is determined as the coefficient ofvariation (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 ofvariation for results obtained by running the same specimen randomly 20 to 30 times during a 24hour period. Typical "Within Day" precision data for the CELL-DYN 1600 are provided in Table 4-5.

Chapter 4 S ystem Specifications


"Day to Day" precision checks long term calibration stability. It is based on thecoefficient of variation for results obtained by running the same lot of commercialcontrol 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.) duringthis period can affect the results.

Table 4-5 Precision at 25 C0

Parameter Typical Typical Typical Absolute1

within Sample within Day Day to Day within Sample

2 3 4

WBC (K/�L) 4.6 - 10.2 4.6 - 10.2 4.6 - 10.2 4.6 - 10.2CV � 2.3% � 2.7% � 3.2% � 2.5%

LYM (K/ �L) 0.6 - 4.1 0.6 - 4.1 0.6 - 4.1 0.6 - 4.1CV � 8.0% � 8.5% � 9.0% � 8.0%

GRAN (K/�L) 2.0 - 7.8 2.0 - 7.8 2.0 - 7.8 2.0 - 7.8CV � 7.0% � 7.5% � 8.0% � 7.0%

RBC (M/�L) 4.04 - 6.13 4.04 - 6.13 4.04 - 6.13 4.04 - 6.13CV � 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 - 18.1CV � 1.0% � 1.2% � 1.5% � 1.2%

HCT (vol %) 37.7 - 53.7 37.7 - 53.7 37.7 - 53.7 37.7 - 53.7CV � 1.5% � 1.7% � 2.0% � 1.7%

MCV (fL) 80 - 100 80 - 100 80 - 100 80 - 100CV � 1.0% � 1.2% � 1.7% � 1.5%

RDW (%) 10.6 - 14.8 10.6 - 14.8 10.6 - 14.8 10.6 - 14.8CV � 3.0% � 3.5% � 4.0% � 3.5%

PLT (K/�L) 142 - 424 142 - 424 142 - 424 142 - 424CV � 5.5% � 6.0% � 7.5% � 6.0%

MPV (fL) 7.5 - 12.5 7.5 - 12.5 7.5 - 12.5 7.5 - 12.5CV � 6.0% � 6.5% � 7.5% � 6.0%

1 Within Sample Protocol: 1 specimen run consecutively 20 times2 Within Day Protocol: 1 specimen run randomly 20 times within a 24-hour period3 Day to Day Protocol: 1 specimen run 20 times 10 consecutive days4 Expected performance at a 95% confidence limit

Chapter 5 Operating Instructions

CELL-DYN® 1600 Operator's Manual 5-19140214 Rev DCJune 1993

Operating Instructions

Introduction This chapter discusses the operation of the CELL-DYN® 1600. It is divided into 7sections:

! 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 menusin the program that are used for routine operation — Run and the Data Log — arediscussed in this chapter. The remaining parts of the program are discussed in thefollowing chapters:

Setup Chapter 2Calibration Chapter 6Quality Control Chapter 7Special Protocols Chapter 9Diagnostics Chapter 10

Data Module Program Overview

The Data Module menus are presented as key labels displayed across the bottom of thescreen. 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 labelsdisplayed across the bottom of this screen are used to access all of the sub-menus thatare available. The MAIN MENU keys are listed below:

[SETUP][RUN][DATA LOG][QC][CALIBRATION][DIAGNOSTICS][HELP][SPECIAL PROTOCOLS]

Operating Instructions Chapter 5


9140214 Rev DCJune 1993

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 thesequence number. The information in the upper right corner is displayed onevery screen during operation.

The cursor is positioned at the <OPERATOR ID> field when the MAIN MENU isdisplayed. An operator ID of up to 3 digits may be entered. This operator ID will bedisplayed 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 nextsample to be run. (Up to 9 characters may beentered.) Refer to the Sample Analysis sectionfor more information about this feature.

2. <TYPE:> used to display the specimen type selected.

3. <PRE-DILUTE> <PRE-DILUTE MODE> is displayed in inversevideo when the <PRE-DILUTE> field is selected.



The Status Box is displayed in the top center of the RUN MENU screen. It containsthe 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 toaccess 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 theWBC and RBC/PLT apertures to remove obstructions. The sequence takesapproximately 35 seconds. When [CLEAR ORIFICE] is pressed, the message<CLEARING ORIFICE> is displayed in the Status Box.



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Pre-Dilute [PRE-DILUTE] turns the pre-dilute mode run cycle ON and OFF. When ON, the<PRE-DILUTE> message appears in the upper right section of the screen. Thespecimen probe is raised and placed over the RBC/PLT dilution bath. This allows theoperator to remove the upper front cover and pour a pre-diluted 1:251 sample into theinitial 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 patientsamples. Patient identification may be entered on the RUN MENU after this key ispressed. Results from this run option are stored in the Data Log.

QC Control(s)

The 3 QC control keys, [LOW CONTROL], [NORMAL CONTROL], and [HIGHCONTROL], are used to select one of the 3 control types. Data from these controlruns are automatically stored in the designated QC file.

Normal Backgrnd

[NORMAL BACKGRND] is used to select a special run mode and to display thebackground results. Results from this run option are identified by the designationBACKGRD in the data log and are automatically excluded from the X-B analysis.



Electricl Backgrnd

[ELECTRICL BACKGRND] is used to select the run mode for electrical backgroundcounts. Electrical backgrounds are used to check for electrical interference in thesystem. (Aperture current is turned OFF during this cycle.) Results from this runoption are identified by the designation ELEC BKGD in the data log and areautomatically excluded from the X-B analysis.

Help

[HELP] displays one or more screens of information that provide a brief explanationof the screen functions and keys. When additional information is available, themessage <MORE> is displayed in the lower right corner. Press the Right Arrow keyto 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 bedisplayed and printed.

Print Ticket [PRINT TICKET] is used to print the current screen data on a ticket. It is used whenthe 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 usedwhen the automatic graphic print feature is set to OFF. When there is no paper in theprinter, the message <PRINTER> appears above the key labels.

Help [HELP] displays one or more screens of information that provide a brief explanationof the screen functions and keys. When additional information is available, themessage <MORE> is displayed in the lower right corner. Press the Right Arrow keyto access this information.

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



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Setup System Operation

The SETUP MENU is used to review and change options for data format to outputdevices such as printers and computers. The units of measure display and print formatoptions 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 keyson the keypad to enter a new number within the stated limits. For example, the numberpreceding the "line-feeds per printer page" statement applies to the graphic printer andindicates 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 theselection requiring change.

Press Enter to toggle between ON or OFF.

OR

Type the new number that is within the limits shown for theselection. Repeat this process until all required changes arecomplete. 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 forcontrol, replicate and X-B program files, etc. Refer to Chapter 2, Installation, forprocedures.


CELL-DYN® 1600 Operator's Manual 5-79140214 Rev F—April 1996

Specimen Collection and Handling

Specimen Stability Fresh whole blood specimens are recommended. The ICSH defines a fresh bloodspecimen as one processed within 4 hours after collection.

Well-mixed whole blood specimens, collected in EDTA anticoagulant and run within 8hours after collection, provide the most accurate results for all parameters. The whitecells size distribution may shift when specimens are assayed between 5 and 20 minutesafter collection or more than 8 hours after collection.

The stability of capillary specimens collected in micro-collection devices may varydepending on the micro-collection device manufacturer. Refer to the manufacturer'spackage 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 NCCLSStandards, 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 routinesample analysis.

• Samples should not be run until the instrument has been initialized and daily QCchecks have been performed.

• Samples may be analyzed whenever READY is displayed in the Status Box onthe RUN MENU.

• Samples should be well mixed before they are run.

CAUTION If the System has been idle for 15 minutes or more, a normal background should be run immediately prior to running any patient specimens.

Operator ID The operator should enter an Operator ID before running samples. The Operator ID isdisplayed on all screens and printed on the graphics report and the ticket report. It is alsoretained in the QC logs and the Data Log.

The Operator ID is entered from the MAIN MENU. When this screen is selected, thecursor is positioned in the <OPERATOR ID> entry field. Type up to 3 digits and press[ENTER] to save the ID number.



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Sample Identification Sample identification information is entered in the upper left corner of the RUN MENU.These entry fields are made available by pressing [SPECIMEN TYPE] followed by[PATIENT SPECIMEN ].

1. A sample ID number of up to 9 digits may be entered in the<NEXT ID> entry field.

2. An auto-increment feature automatically increases the sample ID number by 1digit each time a sample is run.

Alerts and Indicators This section describes information displayed on the screen as the samples are analyzedand/or when reports are printed.

NOTE This section does not discuss how to interpret parameter flags, which are displayed afterthe sample is run. Refer to Chapter 3, Principles of Operation, for detailed explanationsof 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 anasterisk on a pre-printed ticket.

• Results that exceed a parameter's linear range are indicated by >>>> in place ofthe result.

• If a WBC or RBC/PLT metering fault occurs, results are suppressed for theaffected 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 andData/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. TheStatus Box displays the message <FAULT: SEE DIAG> or <SEE SPECIAL>to direct the operator to either the DIAGNOSTICS or the SPECIALPROTOCOLS menu for further instructions.

NOTE After the problem has been corrected, press [CLEAR FAULT] to resume operation.



Instrument Start Up The CELL-DYN 1600 power switches should be left ON at all times. The instrumenthas been designed to automatically maintain itself when it is idle. If the instrument isidle for 4 hours, an automatic shutdown cycle is initiated. The instrument is placed in theSTANDBY 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 toChapter 11, Printers, for complete instructions for printer operation.

A complete procedure for powering the system ON or OFF is given in Chapter 2,Installation.

Daily Start Up Procedures

The automatic Start Up cycle is designed to prime the flow system and check thebackground counts whenever STANDBY or INITIALIZED appear in the Status Box onthe RUN MENU screen. Auto-startup is activated by pressing [RUN] on the MAINMENU.

Startup Procedure 1. Be sure that READY is displayed in the Status Box.

CAUTION If the System has been idle for 15 minutes or more, a normal background should be runimmediately prior to running any patient specimens.

2. If the Status Box on the RUN MENU screen displays STANDBY orINITIALIZED, press [RUN] to initiate the automatic start up cycle.

3. Perform the daily Quality Control checks as directed in the following section.

Daily Quality Control Checks

Quality Control checks should be performed on a daily basis according to thelaboratory's protocol. Commercial control materials should be properly warmed andmixed according to the manufacturer's recommendations. Patient controls should behandled 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: [PATIENTSPECIMEN], [LOW CONTROL ], [NORMAL CONTROL ], [HIGHCONTROL], or one of the nine replicate files. The type currently selected isdisplayed in the upper left section of the screen.

3. Run the control following the “Running Samples” procedure presented on thenext page.



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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 properlyand again repeat the run. If the results are still unacceptable, run the other levelsof control material. If the results on all levels are unacceptable, troubleshootaccordingly. 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 theprobe is immersed in the well-mixed sample. Consider all clinical specimens aspotentially infectious. Use established, good laboratory working practice whenhandling these samples.

3. Press the touch plate located behind the probe to start the cycle. The Status Boxon the RUN MENU displays messages to indicate the various stages of thecycle.

4. Remove the sample tube after the beep sounds. The probe moves up through thewash block for cleaning.

5. When the cycle is complete, the probe moves down into position for the nextsample and the results are displayed on the screen.

6. If automatic report printing has been specified, a report is printed according tothe parameters selected during Setup.

7. Repeat this procedure for subsequent samples.

Daily Shutdown It is not necessary to perform a shutdown procedure daily as the instrumentautomatically 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 [DAILYSHUTDOWN] on the second SPECIAL PROTOCOLS MENU screen. This causesthe equipment to:

1. Rinse the flow system.

2. Set the timer control that periodically opens all of the solenoid valves to preventpinched tubing.



Power Off Procedure

Whenever power to the instrument is to be turned OFF, the operator must perform thesame procedures described above in the automatic shutdown cycle.

1. Press [DAILY SHUTDOWN] on the second SPECIAL PROTOCOLSMENU 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 isrestored.

Using the Data Log

The Data Log stores all data in a log format for the last 320 cycles run on theinstrument. The information is stored chronologically by sequence number.

Data Log Menu When [DATA LOG] is pressed, the DATA LOG screen is displayed and the followingkeys are available:

[FIND SEQ OR SPECIMEN ID][EDIT SPECIMEN ID][REJECT/ACCEPT SPECIMEN][PRINT REPORT FOR 1 SPECIMEN][TRANSMIT DATA][PRINT DATA SUMMARY][HELP][MAIN]

Find Seq or Specimen ID

[FIND SEQ OR SPECIMEN ID] is used to find a specific sequence ID # orspecimen ID # among those displayed on the DATA LOG screen.

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



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Edit Specimen ID [EDIT SPECIMEN ID] is used to edit the Specimen ID # from the DATA LOGscreen. When [EDIT ID] is pressed, the cursor moves to the <SPECIMEN ID> fieldand 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 sequencenumber, 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 selectedspecimen indicated by the position of the cursor in patient report format or ticketformat.

NOTE No histogram data is stored or printed.

When [PRINT REPORT FOR 1 SPECIMEN] is pressed, the following keys areavailable:

[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 startingand ending sequence numbers (from the lowest to the highest) for the desiredtransmission. Records may be transmitted singly or in batches as designated by thesequence numbers.

NOTE No histogram data is stored or printed.

Print Data Summary [PRINT DATA SUMMARY] performs the same task as [TRANSMIT DATA], onlythe data is printed on the graphics printer rather than transferred to an on-linecomputer.



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

2. NCCLS Standard H4-A3, Procedure for the Collection of Diagnostic BloodSpecimens by Skin Puncture—Third Edition; Approved Standard (1991).



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Chapter 6 Calibration


Calibration

Introduction The CELL-DYN® 1600 is calibrated at the factory just before shipment. An Abbottauthorized Field Service Representative assists the operator in confirming thecalibration during instrument installation. Calibration may be performed withcommercial calibrator or fresh whole blood samples. Only the directly measuredparameters WBC, RBC, HGB, MCV, PLT, and MPV may be calibrated.

The instrument is electronically stable and should not require frequent recalibrationwhen it is operated and maintained according to the recommendations in this manual.On-board quality control programs are designed to provide continual monitoring andverification of instrument calibration. The laboratory should make the decision torecalibrate based on the performance of the CELL-DYN 1600 in these quality controlprograms. The programs include statistical computations and Westgard Rules forcommercial or patient controls and monitoring of patient samples for RBC parametersusing Bull's moving average program (X-B).

Calibration should be confirmed on a regular basis according to the requirementsgoverning quality control in your laboratory. In keeping with good laboratorypractices, this should include daily verification on each shift and following a reagentlot number change. Verification of calibration is also recommended following thereplacement of any major instrument component that could affect calibration.Calibration may be verified by running appropriate commercial controls or by usingfresh whole blood samples that were analyzed on a reliably calibrated hematologyanalyzer 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-dilutemode are then referenced to it. There are several ways to accomplish the totalcalibration, depending only on the preference of the user. The following CalibrationProcedural Guidelines section provides a quick reference guide to the remainder of thechapter.

Calibration Chapter 6


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Calibration Procedural Guidelines

There are several ways to accomplish total calibration of the system. They are:

! Auto-Cal — automatic calibration program incorporated in the software! Factor Entry Calibration — an alternative to Auto-Cal! Lyse Volume Dispense Calibration! Latex Particle Calibration (MPV only)

The instrument's Open mode is calibrated with the calibration material of choice, usingthe method of choice. The Closed mode is then referenced to match the Open modewith fresh whole blood samples (refer to the Addendum section of this manual forinstructions). This chapter contains an overview of the calibration methods and gives adetailed explanation of how to perform each procedure. Review the Pre-CalibrationGuidelines section before beginning the selected calibration procedure.

The calibration procedures have been divided into subsections that consist of a seriesof easy-to-follow steps. Always follow the entire procedure unless specifically directedto skip to another section.

For manual calibration, worksheets may be used to assist in making the necessarycalculations. These worksheets may be duplicated as needed.

Calibration Materials

CAUTION Consider all clinical specimens and controls, calibrators, etc. that contain human bloodor serum as potentially infectious. Use established, good laboratory working practiceswhen handling these samples. Wear gloves, lab coats and safety glasses and followother biosafety practices as specified in the OSHA Bloodborne Pathogen Rule or otherequivalent biosafety procedures.

3 calibration materials can be used to calibrate the CELL-DYN 1600:

! CELL-DYN calibratorA calibrator is the preferred material for calibrating the CELL-DYN 1600. Itis most efficiently performed by calibrating the Open mode using the Auto-Calmethod. The Closed mode is then referenced to match the Open mode usingfresh whole blood samples.

NOTE The term “calibrator” refers to a commercial reference material—either calibrator orcontrol. According to the Food and Drug Administration (FDA), when a control isused as a calibrator, a different lot or brand of control must be used for daily qualitycontrol.

NOTE Never use a hemoglobin standard that is designed specifically for use withcyanmethemoglobin reagents.



! Latex ParticlesLatex particles are used to calibrate the Mean Platelet Volume. Thiscalibration is verified by an Abbott authorized representative duringinstallation of the instrument.

! Fresh Whole BloodCalibration with fresh whole blood is accomplished by performing multipleanalyses of each sample by acceptable reference methodology and calculatingthe mean reference value for each parameter. The same samples are analyzedon the CELL-DYN 1600 in the Open mode. The Closed mode is thenreferenced to match the Open mode using another set of fresh whole bloodsamples. A detailed discussion of Whole Blood Calibration is given in the nextsection.

Whole Blood Calibration Guidelines

Introduction Calibration with fresh whole blood samples is an alternative to calibration with acommercial calibrator. This section explains the determination of reference values andgives requirements for whole blood samples.

Sample Requirements for Fresh Whole Blood

The following requirements should be observed for fresh whole blood samples used forcalibration:

! The ICSH recommends that fresh samples be less than 4 hours old. Sample agemust not exceed 8 hours at the conclusion of the calibration procedure.

! All parameter values should be within the laboratory's normal range. Thefollowing ranges are programmed for the reference values that may be enteredin the Auto-Cal program. Results exceeding these limits cannot be entered.

WBC 5.0 — 12.0RBC 3.50 — 5.50HGB 10.0 — 24.0MCV 80 — 100HCT 30.0 — 50.0PLT 150 — 400



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NOTE Obtain a reference RBC and HCT value for each calibration specimen. When the RBCand 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 thefollowing ICSH recommendations.

WBC, RBC, and PLT

Reference values may be determined using multiple counts from a certifiedhemocytometer or from a reliably calibrated hematology analyzer.

Hemoglobin Reference values may be determined using either the reference cyanmethemoglobinmethod or a reliably calibrated hemoglobinometer or hematology analyzer.

NOTE DO NOT attempt to calibrate the CELL-DYN 1600 with a hemoglobin standarddesigned for the calibration of specific reference cyanmethemoglobin methods. Theinstrument uses a modified hemiglobincyanide method which is not designed to analyzethese standards directly.

MCV Reference values may be determined by calculation from the referencemicrohematocrit and RBC measurements or from multiple analyses on a reliablycalibrated hematology analyzer.

NOTE Reference microhematocrit values may be determined by multiple analyses using theNCCLS method for Packed Cell Volume (PCV). Use only plain (non-anticoagulated)capillary tubes. Be certain to verify the proper operation of the microhematocritcentrifuge and the timer as recommended by NCCLS.



Calibration Requirements for Fresh Whole Blood

Minimum requirements for Whole Blood Calibration are described in the followinglist. 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 theCELL-DYN 1600 first, assay by reference methodology should be completedwithin 1 hour. (Certain reference methodologies are sensitive to RBC swellingcaused by in vitro deoxygenation.)

! Mean values should be calculated for each parameter for each sample from thereference assay results. These mean parameter values can then be entered inthe Auto-Cal program as reference values for each sample.

! If Auto-Cal is not being used, the mean parameter values should be averagedto obtain the cumulative mean value for each parameter.

NOTE A worksheet is provided on the following page. This worksheet may be used to assistwith the calculation of the reference means and may be duplicated as needed.



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Whole Blood Calibration Reference Values Worksheet

Date:__________________________________ Parameter: _____________________________

Technologists: __________________________ Method: _______________________________

Sample Reference Assays MeanID

1 2 3 4 5 6 7 8 9 10

Cumulative Parameter Mean



Pre-Calibration Procedures

It is advisable to perform calibration at a time when it can be completed withoutinterruption. The Pre-Calibration Procedures in this section verify proper instrumentperformance to ensure a successful calibration. These steps must be completed justbefore beginning calibration. If problems are detected during these checks, DO NOTATTEMPT TO CALIBRATE THE INSTRUMENT. If necessary, call the CustomerSupport Center for assistance. After the problems have been resolved, repeat the pre-calibration procedures to verify proper performance. Review the following guidelinesbefore 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, eachlaboratory should perform any additional maintenance according to itsrequirements.

• Confirm that Normal Background is within limits.• Confirm that the operator ID number is entered.

CAUTION If the System has been idle for 15 minutes or more, a normal background should be runimmediately prior to running any calibration specimens.

Calibration Logbook

Abbott suggests that you create a logbook for the instrument. This logbook shouldcontain all necessary calibration documentation and other information that is pertinent toyour 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 andAbbott Service Personnel.

Calibration Menu Screen



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The CALIBRATION MENU screen is accessed from the MAIN MENU screen bypressing [CALIBRATION][CALIBRATION]. The CALIBRATION MENU screen is explained in thissection.

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 isexplained in this section.

Enter Factor [ENTER FACTOR][ENTER FACTOR] is used to enable the operator to enter calibration factorsdirectly (Factor Entry Method).

Pre-dilute [PRE-DILUTE][PRE-DILUTE] is used to toggle between selecting and deselecting the pre-dilute mode and to loadcorresponding calibration factors for review and possible change.

Auto-Cal Select [AUTO CAL SELECT][AUTO CAL SELECT] is used to display the screen labels for the calibrator, freshwhole blood, and latex particles calibration methods.

Calibrator [CALIBRATOR][CALIBRATOR] initiates calibration using a calibrator.

Fresh Blood [FRESH BLOOD] [FRESH BLOOD] initiates calibration using fresh blood specimens.

Latex Particles [LATEX PARTICLES] [LATEX PARTICLES] initiates calibration of MPV using latex particles.

Lyse Volume [LYSE VOLUME][LYSE VOLUME] selects the menu for lyse volume procedures.

Print [PRINT][PRINT] is used to print a report of the current calibration factors.

Return [RETURN][RETURN] returns the display to the main calibration screen.

Auto-Cal Method

Introduction This method allows the operator to enter reference assay values and run either wholeblood or calibrator with CELL-DYN 1600 reference values. The computer utilizes theentered results from a minimum of 3 runs to calculate a factor for each specimen. A



Auto-Cal Method

Introduction This method allows the operator to enter reference assay values and run either wholeblood or calibrator with CELL-DYN 1600 reference values. The computer utilizes theentered results from a minimum of 3 runs to calculate a factor for each specimen. Amean factor is calculated for all specimens run.

Procedure 1. Obtain the appropriate calibration materials, either calibrator or fresh wholeblood.

! If a calibrator is used:— Ensure that commercial calibrator vials are brought to room

temperature and mixed according to the manufacturer'sinstructions 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 berun (RBC calibration requires 3 digits). The cursor automatically advances tothe next selection.

NOTE When MCV is selected, the message <REFERENCE VALUE FOR MCV MAY BESUPPLIED BY ENTERING VALUES FOR RBC AND HCT. TO DO SO,PRESS # AND ENTER VALUES WHEN PROMPTED.> appears in the lowerscreen. When [#] is pressed, MCV changes to RBC, allowing the operator to enter thered cells reference value (using 3 digits). Then <HCT> appears allowing the operatorto enter the hematocrit reference value. The computer calculated MCV reference valuemust 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 thecalibration specimen are selected and the corresponding reference values areentered.

9. Mix the specimen well by inverting it at least 10 times. Do not shake thespecimen.



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10. When <READY> appears, place the well-mixed specimen under the aspiratingprobe and press the Touch Plate to actuate the auto-calibration cycle. Theanalyzer performs RUN 1 measurement and displays the values in the RUN 1column.

11. When the cycle is complete, repeat step 10 twice — once for RUN 2measurement and once for RUN 3 measurement.

NOTE When the value for any run exceeds the computer acceptance criteria, the value ishighlighted indicating the measurement cycle must be repeated. Should this situationoccur repeatedly, press [ABANDON] to stop the auto-calibration process for thisspecimen 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 calculatedusing the accepted run data for each parameter selected in steps 4 and 7. Thescreen displays the calculated factor and mean factor for each parameterindicating 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 themean factor for all specimens run prior to pressing the key.

14. After all calibration factors are run, press [RETURN]. The main calibrationscreen appears. The calibration factors are saved at this point.

15. Press [PRINT] to print the new calibration factors.

16. Press [MAIN] to return to the MAIN MENU screen.

17. Press [RUN] to return to the RUN screen.

18. Run one of the following:

! 3 additional specimens with reference assay values! 3 levels of controls

19. Confirm that the results obtained for each specimen:

! agree with the reference value within 2SDOR

! are within control limits.

NOTE If the results for any parameter are consistently out, repeat calibration or obtaintechnical assistance.



Factor Entry Method

Introduction Enter factor key calibration is used to reset calibration to the factory calibration settingof 1.00. It can also be used to enter a pre-determined factor to adjust calibration whena consistent bias exists between CELL-DYN 1600 and a comparison analyzer orreference method. A percent bias factor can be determined and entered to changecalibration within ± 20% for any of the directly measured parameters — WBC, RBC,HGB, MCV, PLT, MPV.

Procedure 1. Run in triplicate, multiple (minimum of 3) specimens via comparison analyzeror method.

2. Calculate a cumulative reference mean (REF) for all specimens and runs foreach 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 withan empty replicate file selected. Run all specimens in the same replicate file toobtain 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 toobtain a cumulative CD mean for each parameter.

7. Divide the reference mean from step 2 by the CELL-DYN 1600 mean printedin 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 (6.6divided by 7.2 = 0.917)

! When REF is 6.6 and CD WBC is 5.9, the calibration factor is 1.12 (6.6divided by 5.9 = 1.119).

8. At the MAIN MENU screen, press [CALIBRATION]. A new screen and newlabels 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 typethe new factor using 3 digits. To reset the number to the current factorysetting, type [1] [0] [0].



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11. Repeat the previous step (step 10) as required to enter a new factor for eachparameter.

12. Press [RETURN] to return to the main calibration screen. As required, press[PRINT] to print the current calibration status.

13. Press [MAIN].



! 3 additional specimens with reference assay values! 3 level controls.

16. Verify that the results obtained for each specimen:



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



Pre-Dilute Method

Introduction The pre-dilute calibration mode allows the operator to calibrate the CELL-DYN 1600to adjust for any differences due to dilution when this special mode is selected. Thepre-dilute calibration procedure and specimens are similar to the whole blood orcalibrator method given earlier in this chapter. However, for pre-dilute calibration eachcalibration specimen is pre-diluted in the same manner as unknown patient specimensusing CELL-DYN micropipettes 40uL end-to-end (30mm) with EDTA and 10mL ofdiluent that is dispensed using [10ml. DISPENSE] from the SPECIALPROTOCOLS screen.

Procedure 1. Obtain either a calibrator with CELL-DYN 1600 calibration reference valuesor one or more calibration specimens that meet the guidelines for eachparameter.

2. Press [SPECIAL PROTOCOLS] to go to the SPECIAL PROTOCOLSscreen.

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 eachspecimen 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 berun (e.g. <4> <8> <9> for RBC). The reference assay value always requires 3digits. The cursor automatically advances to the next selection.



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Figure 6-1 Removing the Front Cover

NOTE When MCV is selected, the following message appears in the lower screen: <THEREFERENCE VALUE FOR MCV MAY BE SUPPLIED BY ENTERINGVALUES FOR RBC AND HCT. TO DO SO, PRESS # AND ENTERVALUES 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 computercalculated MCV reference value must be within the normal range of 80 to 100 to beaccepted and displayed.

13. Repeat steps 10 through 12 until all parameters to be calibrated with thiscalibration specimen are selected and the corresponding reference values areentered.

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. Setthe cover aside or on top of the analyzer. (See Figure 6-1.)

WARNING To prevent aspirating probe damage, always confirm the probe is raised beforeattempting to remove the upper front cover.

NOTE The grounding wire may be detached to completely remove the Upper Front Cover.

15. Mix the calibration specimen well by inverting it at least 10 times. Do notshake the specimen.

16. Completely fill a CELL-DYN micropipette with well-mixed calibrationspecimen.



Figure 6-2 Vial Closure for Mixing

17. Wipe the outside of the pipette with a lint-free gauze slightly dampened withdiluent to remove excess blood. DO NOT REMOVE THE BLOOD FROMINSIDE THE PIPETTE.

18. Drop a filled pipette immediately into a vial containing 10mL of diluent. (Thisvial was prepared in step 5.)

19. Close the vial at the upper crease and invert a minimum of 15 to 20 times tothoroughly mix the blood and diluent (see figure 6-2).

NOTE The internal bore size of the CELL-DYN micropipette is designed to allow rapidmixing of blood and diluent. This initial 1:250 dilution is stable for 20 minutes andmust be thoroughly remixed by inversion before pouring it into the initial dilution bathwhen the pre-dilute mode is selected.

20. Open the vial and carefully pour the diluted specimen into the initial dilutionbath.

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. Thisperforms the RUN 1 measurement and displays value(s) in the RUN 1column.

22. When the cycle is complete, repeat steps 15 through 21 twice — once for RUN2 measurement and once for RUN 3 measurement.

NOTE When the value for any run exceeds the computer acceptance criteria, the value ishighlighted indicating the measurement cycle must be repeated. Should this situationoccur repeatedly, press [ABANDON] to stop the auto-calibration process for thisspecimen 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 eachparameter selected in steps 10 and 12 is calculated using accepted run data.The screen displays the factor and mean factor for each parameter indicatingthe auto-calibration cycle for this specimen is complete.



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NOTE Do not press [RESET FACTORS] between specimens. This key is used to delete themean factor for all specimens run prior to pressing the key.

24. Repeat steps 12 through 22 for each calibration specimen.

25. When all calibration specimens are run, press [RETURN]. The calibrationfactors are now saved. The main calibration screen appears.


27. Press [MAIN].


29. Press [PRE-DILUTE] to select the pre-dilute mode.


! 3 additional specimens with reference assay values! 3 levels of controls via the pre-dilute method.




NOTE If results for any parameter are consistently out, repeat the calibration or obtaintechnical assistance.

Latex Particles Method

Introduction Calibration is required when mean platelet volume (MPV) values for QC specimensindicate that MPV is out-of-calibration. This procedure enables the operator tocalibrate MPV utilizing latex particles. To date there is no acceptable referencemethod established for determination of a reference MPV. MPV calibration requireslatex particles, and must be calibrated using this method.

Guidelines for Calibration

Review the following guidelines before beginning this calibration procedure.

! Use only the required latex particle and reagents. Other brands areunacceptable.

! Resuspend latex particles according to the directions provided in the packageinsert.



Procedure 1. Obtain latex particles and mix them according to the directions provided in thepackage insert to completely resuspend them.

NOTE Aggregates will cause invalid calibration for MPV.

2. At the MAIN MENU screen, press [CALIBRATION].

3. Press [LATEX PARTICLES]. A new screen appears.

4. Set the cursor to MPV and press [ENTER]. The screen changes.

5. Enter the reference assay value for latex particles to be run (using 3 digits).

6. Mix the calibration specimen well by inverting it at least 10 times. Do notshake the specimen.

7. When <READY> appears, place the well-mixed calibration specimen underthe aspiration probe. Press the Touch Plate to actuate the auto-calibrationcycle. This performs the RUN 1 measurement and displays values in the RUN1 column.

8. When the cycle is complete, repeat step 7 twice — once for RUN 2measurement and once for RUN 3 measurement.

NOTE When the result for any run exceeds the computer acceptance criteria, the result ishighlighted indicating the measurement cycle must be repeated. Should this situationoccur repeatedly, consult Chapter 10, Troubleshooting, or obtain technical assistance.

9. When results for 3 runs are acceptable, the calibration factor is calculatedusing the accepted run data. The calculated factor and mean factor displayindicating the auto-calibration cycle is complete.

10. Press [RETURN]. The main calibration screen appears.


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



! 3 additional specimens with reference assay values! 3 levels of controls.



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NOTE If results for any parameter are consistently out, repeat calibration or obtain technicalassistance.

Lyse Volume Dispense Calibration

The volume of lyse dispensed is factory set. The amount of lytic reagent dispensedaffects the diff-screen results and can vary slightly as a result of tubing and rotor wearduring routine use. When lytic action is too little (increased alerts and size data shiftedto the right), the amount of lyse dispensed can be increased. When lytic action is toogreat (increased alerts and size data shifted to the left), the amount of lyse dispensedcan be decreased.

Verification of the volume of lyse dispensed per cycle is required when the lyse tubeunder the pump rotor is replaced. It should be reset as needed to maintain diff-screenresult accuracy. For special applications or research, the amount of lytic reagentdispensed 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 thatappear when [LYSE VOLUME] is pressed. A 25mL graduated cylinder is requiredfor this procedure.

Procedure 1. At the MAIN MENU screen, press [SPECIAL PROTOCOLS].

2. Press [MORE] until [10ml. DISPENSE] appears.

3. Place a 25mL graduated cylinder under the aspiration probe and press [10ml.DISPENSE] twice to actuate the dispense.

4. Repeat step 3 to dispense an additional 10mL of diluent. Determine inmilliliters the exact amount of diluent in the cylinder.

5. Press [MAIN].


7. Press [LYSE VOLUME]. A new screen appears.



8. Remove the lyse inlet tubing from the lyse container and place it into the 25mLgraduated cylinder. Make sure the end of the tubing touches the bottom of thecylinder.

9. Press [MEASURE VOLUME] to activate 10 consecutive lyse dispensecycles. This is a default cycle and disregards any entered volume.

10. When the lyse pump action stops, remove the lyse inlet tubing and measure theamount of the diluent aspirated. For an accurate measurement, the lyse tubingmust be removed.

NOTE Default dispense volume: The measured volume of diluent in milliliters from step 3minus the measured volume of diluent remaining in the cylinder equals the volume oflyse dispensed during 10 cycles.

11. Enter the default dispense volume in milliliters using the keyboard numerickeys (9.0 to 11.0).

12. Press [SET VOLUME]. The current set volume appears with the set volumestatement.

13. Type the new volume for lyse dispense in milliliters using the keyboardnumeric keys (0.75mL to 1.25mL).

NOTE The new volume is the number obtained in step 10 divided by 10.

14. Press [ENTER].

NOTE When no entry is made, no screen labels appear. Press [ENTER] to continue.

15. Repeat steps 1 through 3 to add additional diluent to the cylinder.

16. Place the end of the lyse tubing into a 25mL graduated cylinder. Confirm theend of the tubing touches the bottom of the cylinder.



19. Press [LYSE VOLUME].

20. Press [VERIFY VOLUME].

When the lyse pump action stops, remove the lyse inlet tubing and measure the amountof diluent aspirated. This number should equal the new volume entered in step 13multiplied by 10 ± 0.2mL.

NOTE If the two volumes do not agree, repeat this entire procedure or obtain technical



9140214 Rev DCJune 1993

assistance.

21. Remove the lyse inlet tubing from the cylinder.

22. Press [VERIFY VOLUME]. Air circulates through the tube.

23. Place the lyse inlet tubing in the container of lyse.

24. Press [VERIFY VOLUME] again to refill the lyse inlet tubing with lysereagent.

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 2SDOR


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

Chapter 7 Quality Control


Quality Control

Introduction The CELL-DYN® 1600 offers several Quality Control (QC) options to monitor andvalidate instrument performance. The options are:

Commercial Controls — Numeric data obtained for each parameter areautomatically transmitted to a designated file (low control, normal control, or highcontrol) when that control file is selected.

Replicate Specimen — This option works the same as the Commercial Controlsprogram. 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 thecalibration of the red cells parameters.

Quality Control Log

This section discusses the options available when [QC] is pressed at the MAINMENU. The options used to set up the QC files are available by pressing [SET UP]at the MAIN MENU. Refer to the Keypad Setups section of Chapter 2, Installation,for details regarding setting up the Control Files, Replicate Files, and X-B Files.

The QC LOG screen allows the operator to perform the following functions:

C Select 1 of 12 QC filesC 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 variationC 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 theoperator to review or print a composite report, including the batch mean for each X-Bparameter — MCV, MCH, and MCHC — calculated for the last 20 batches. Eachstored batch mean is plotted.

Quality Control Chapter 7



Low Control, Normal Control, High Control

The control keys initiate the display of the appropriate CONTROL FILES screen andnew 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] ispressed, the screen label changes to [RESTORE]. Press [RESTORE] to cancel thepurge. Press [RETURN] to complete the purge.

NOTE Once [RETURN] is pressed, data in the file is permanently erased. [RESTORE] willnot 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 [RESTORESPECIMEN]. 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 thedesired replicate file and display the data. The keys available from the REPLICATE 1through 9 MENU are described below.

Purge REPL ––> CONT

This function purges data from the file or copies it into a control file. To copy thereplicate 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 areplicate file to a control file. Press the key corresponding to the desired control file([COPY LOW], [COPY NORMAL], [COPY HIGH]). Press [RETURN] to exit thecopy 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 [RESTORESPECIMEN]. 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 guidelinesfor basic assay verification. The section on Westgard Rules defines the rules used andgives guidance for their application in the hematology laboratory. The commercialcontrols, replicate specimen, and X-B analysis programs are discussed in detail in thelast section.

All QC data should be reviewed according to your laboratory's protocol. Refer to theappropriate sections in this chapter for suggestions and guidelines for interpreting theresults.

Running Controls

Control Material Abbott recommends using the CELL-DYN control materials for performing qualitycontrol 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 inthe 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 andnot 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.


CELL-DYN® 1600 Operator's Manual 7-59140214 Rev FCApril 1996

$ Verify values for the new lot of control by running each level as describedin the "Assay Verification" section, along with either replicate QCspecimens 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 knownreference values. When calibration verification results are acceptable, eitherestablish a new working mean and limits for each level of the new lot ofcontrol or call the Abbott Customer Support Center.

CAUTION If the System has been idle for 15 minutes or more, a normal background should berun immediately prior to running any control specimens.

Mixing and Handling

Always mix and handle commercial control materials according to the directionsgiven in the package insert. As the directions may vary from manufacturer tomanufacturer, pay particular attention to the following:

$ Store the controls at recommended temperatures. Storage in a centrallocation in the refrigerator, away from the door if it is opened frequently, isadvisable.

$ Carefully warm and resuspend the product according to the directions givenin the package insert. Proper mixing is essential for accurate results.

$ Check the open-vial stability dating and do not use products longer than isrecommended or results may be compromised.

Assay Verification New lots of control material should be analyzed in parallel with current lots prior totheir expiration dates. This may be accomplished by running the new lot of controlstwice a day for five days using any empty replicate files. The replicate files calculatethe mean, standard deviation and coefficient of variation for each stored parameter.The instrument-calculated means of these ten runs should be within the expectedranges published by the manufacturer.

Replicate files may be set up for the new lot number to easily establish the meanvalues. However, the replicate files store only the absolute values for the three-partdifferential. 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 effectivequality control. Therefore, your laboratory's established means and SDs for the new1

controls lots should be edited into the appropriate Quality Control file when new lotsare placed into daily use. As a result, these ranges will now be used by the system toautomatically monitor all parameters for each control run. These ranges may bedetermined by evaluating three to six months of data (data from the InterlaboratoryQC Program may be used) for a particular level of control.

(N1 × SD 21 )%(N2 × SD 2

2 )%...(Ni × SD 2i )

(N1 % N2 % ...Ni) & 1




The individual SD values may be averaged as follows:

Average SD =

N = number of values in a groupSD = standard deviation of the valuesi = the last group of values

The resultant long-term instrument SD and the laboratory-established mean for eachlot number should be used to monitor instrument performance.

Differential Percent Verification

The differential percents (LYM, MID*, GRAN) are not stored in the Quality ControlLogs. If statistical analysis of these parameters is required, it needs to be performedmanually.

The replicate files store only the absolute values for the three-part differential. Tovalidate the differential percents, manually record the values from the RUN screendisplay or from a printout of each control run. The differential percentage data canthen be used to calculate the mean values. These mean values (absolute values and/orpercent values), in conjunction with the laboratory's established SDs, may be used tomonitor 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 theCELL-DYN 1600 shows acceptable accuracy and precision. The limits are derivedfrom the mean and standard deviation of control measurements obtained when theinstrument performance is stable and acceptable. The most common rule used inhematology quality control is the mean ± 2SD limits. 95% of the control resultsshould fall within the ± 2SD limits.

Quality control rules detect random or systematic error. Random error may bedefined as an increase in the SD (loss of precision); systematic error may be definedas a shift in the mean value (loss of accuracy). A multi-rule quality control procedurecombines several control rules to improve the detection of both types of error.



CELL-DYN 1600 Westgard Rules

The rules may be used singly or in combination depending on the operator preference.Selections are made on the QC FILE SETUP screen.

When a rule is violated, the bulletin line displays the <WESTGARD WARNINGS:SEE LEVEY-JENNINGS> message. The number of the rule that was violated isdisplayed 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 theresults is greater than 4SD.

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

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

Rule 6: 12 consecutive values on the same side of the mean 12 consecutive results fell on the same side of the mean.

Rule Violations Only the directly measured parameters need to be monitored with multiple rules. In1

reference 1, (pp. 190-192), Cembrowski suggests a protocol for using the WestgardRules in hematology. Following is a synopsis of that protocol.

Since 3 levels of control are typically used to monitor a hematology analyzer, it isreasonable to consider all 3 runs at the same time. In other words, check for the ruleviolations across the 3 levels, not just within a particular level. If the same rule isviolated for more than one level, determine whether the violation indicates a loss ofprecision or a loss of accuracy, and troubleshoot accordingly.




Cembrowski suggests that the results for all 3 levels first be checked to see if they arewithin 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 theparticular level of control. Therefore, if a result exceeds 3SD, run another vial of thatcontrol. 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 thatlevel. 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 thatthe control is run into the correct file.

If a combination of rules has been violated across the 3 levels, determine whether theviolations indicate a loss of precision or a loss of accuracy, and troubleshootaccordingly. If necessary, call the Abbott Customer Support Center for assistance.

When the problem has been resolved, Cembrowski suggests that all levels be run againin 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 eachlevel 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. Printedpackage insert reference mean and limits, the lot number, and the expiration date forcontrol specimen in each file is also entered via SETUP. Parameter data obtained forany control run that falls outside of these entered limits display in inverse video andprint underlined to alert the operator.

QC file summary data or Levey-Jennings plot data currently in each file can bedisplayed and printed. Each time a QC specimen is run, the mean, standard deviation,and coefficient of variation for each parameter is calculated and updated automaticallyfor current run data in each file. The operator can, at any time, reject any run withflagged (outside entered limits) data from this calculation. Additionally, the operatorcan delete any run from a QC file.



Replicate Specimen QC Program

Nine separate files are available for this program. Numeric data for each parameter,for up to 30 runs, stores in each file and can be displayed or printed at any time.

Alerts, calculations, and plots are the same as those stated above for the commercialcontrol QC program. SETUP is used to activate or deactivate the Westgard Rules andto enter comparison data.

X-B Analysis QC Program

Introduction X-B analysis is an automated means of monitoring instrument performance by usingthe known stability of the red cell indices.

X-B represents the moving average of hematology values calculated using analgorithm developed by Dr. Brian Bull. The X-B analysis uses the Bull algorithm tomonitor instrument performance by tracking the average red cell indices in the patientpopulation analyzed on the instrument.

The red cell indices MCV, MCH, and MCHC are known to be stable because the redcell 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 cellsbefore altering the average volume or hemoglobin concentration of those red cells.Consequently, the average red cell indices of a given patient population will vary nomore than 0.5% from day to day and even year to year, providing the population doesnot change. The X-B algorithm provides a means of utilizing this information forquality control on the CELL-DYN 1600.

The X-B algorithm analyzes the indices for MCV, MCH, and MCHC on the patientsamples 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 thecalculation. As a result, each newly calculated batch mean includes data from previousbatches.

When the X-B program is ON and the patient specimen type is selected, the third lineof the RUN screen displays the current X-B program status (e.g. <TYPE: PATIENTX-B: N/IN>; N is the number in the current batch and IN indicates the last batch waswithin the target and limits for all three parameters). In the DATA LOG, a B in frontof a sequence number identifies each patient specimen accepted in the current X-Bbatch.



9140214 Rev F—April 1996

Lower/Upper Acceptance Limits

The lower and upper limits determine which patient results will be used in the X-Bmoving average calculation. They should be set widely to exclude grossly abnormalsamples 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 isderived 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 study by Dr. Bull collected data from 1767 hospitals and yielded the2

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 study . Consequently,3

the values shown above can be used as the Target Values to initiate the X-B Analysisprogram.

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



1. Collect data for a minimum of 20 batches. Calculate the mean, SD, and CV foreach index using the batch means. The CV on 400 samples (20 batches) for eachindex 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 samplesshould be evaluated.

2. If the CVs calculated in Step 1 are less than 1.5%, enter the mean as theconfirmed target value.

Interpreting X-B Results

A suggested protocol and guidelines for interpreting X-B data can be found in Chapter1 of Laboratory Hematology, An Account of Laboratory Techniques, edited by I.Chanarin.4

CELL-DYN Controls

The CELL-DYN controls are packaged as follows:

• Tri-level, 1 box, 2.5 mL vials x 12• Tri-level, 1 box, 3.0 mL tubes x 12

References 1. Cembrowski GS, Carey RN. Laboratory quality management, pp. 189, 190-192.

2. Bull BS, Jones AR, Gibson M, Twedt D. A method for the independentassessment 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 LabMed 1985; 109:604-606.

4. Chanarin I, ed. Laboratory hematology, an account of laboratory techniques.Edinburgh: Churchill Livingston, 1989:3-7.

Chapter 8 Precautions, Limitations and Hazards


Precautions, Limitations and Hazards

Limitations • The CELL-DYN 1600 is designed for in vitro diagnostic use.®

• Abbott has designed the CELL-DYN 1600 system components for optimalperformance. Substitution for reagents, calibrators, controls and componentsmanufactured by other companies may adversely affect the performance of theAnalyzer.

• Follow the recommended maintenance schedules and procedures as outlined inChapter 9, Maintenance, of this manual.

• During the warranty period, all services and repair must be performed byAbbott 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 thesystem:– 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 theback of the analyzer.

• Before operating the instrument for the first time, verify that each reagent lineis connected to the appropriate inlet and reagent container.

Precautions, Limitations and Hazards Chapter 8



• Make sure the waste line is connected to the appropriate outlet and routed to asuitable 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 adrain, 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 groundedoutlets.

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 powercord connector. Use replacement fuse of the specified type and electrical ratingonly. Refer to Chapter 10, Troubleshooting, for detailed instructions.

Mechanical Safety Precautions

CAUTION Avoid contact with needle tips at all times (CS model) to prevent possiblecontamination with potentially infectious materials.

• Wear gloves and safety glasses and use extreme caution when performing anymaintenance procedures on the following components, as they can pinch orpuncture:

– Aspirate probe

– Closed Sampler Needle (CS model)

Infection Control

• Consider all clinical specimens and controls, calibrators, etc., that containhuman blood or serum as potentially infectious. Use established, good,laboratory working practices when handling these samples. Wear gloves, labcoats and safety glasses and follow other biosafety practices as specified in theOSHA Bloodborne Pathogen Rule or other equivalent biosafety procedures.

• Do not smoke, eat or drink in areas where test samples are handled. Do notpipette by mouth.

Chapter 8 Precautions, Limitations and Hazards


Decontamination Procedures

• Decontaminate the instrument by performing the Auto-Clean cycle. This cycleflushes all of the fluid pathways with reagents to purge any waste from thefluid pathways. (The Open Sample Aspiration Probe and the CS Needle areautomatically rinsed after every cycle.) The surfaces of the instrument shouldbe wiped with a non-abrasive detergent solution to remove any soiling. Thisshould 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 SPECIALPROTOCOLS MENU. Instructions are given in the Non-ScheduledMaintenance section of Chapter 9, Maintenance.

Blood Samples

• Decontaminate and dispose of all specimens and potentially contaminatedmaterials in accordance with local, state, and federal regulations.

• Waste liquid is a possible source of biological and chemical hazard. Handlewith extreme care during the disposal process.

• Refer to the Sample Collection and Handling section in Chapter 5, OperatingInstructions, for precautions and limitations pertaining to sample collection andhandling. This section also includes information on interfering substances.

SpillsClean up spills of potentially infectious materials in accordance with establishedbiosafety practices. A generally accepted procedure for clean up of such spills is toabsorb the spill with toweling or other absorbent material, wipe the area with adetergent solution and then wipe the area with an appropriate hospital disinfectantsuch as 10% chlorine bleach.

Precautions, Limitations and Hazards Chapter 8


9140214 Rev DCJune 1993

Reagent Storage and Handling

• Store reagents, calibrators and controls according to the directions in theenclosed package inserts.

• Protect reagents from extreme heat and freezing during storage. Temperaturesbelow 32 F (0 C) may cause layering that changes the tonicity ando o

conductivity of the reagent. If freezing occurs, do not use the reagent.

• Protect reagents from direct sunlight, evaporation and contamination. Use ofthe reagent container cap attached to each inlet tubing minimizes the latter twooccurrences.

• Never add remaining reagent from a container being replaced to a freshlyopened container. This may contaminate the new reagent.

• Never use a hemoglobin standard designed for use with referencecyanmethemoglobin methodology directly on the CELL-DYN 1600. TheCELL-DYN 1600 uses a modified hemiglobincyanide method which is notdesigned to analyze these standards directly.

Printer Precautions

The printhead can get very hot during extended periods of printing. Allow it to coolbefore touching.

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 lengthenthe operational life of the analyzer and to minimize system problems that lead toimprecision and inaccuracy. This chapter describes the recommended preventivemaintenance procedures and provides instructions for preparing the analyzer for anextended period of inactivity.

NOTE Following maintenance, run commercial control or quality control (QC) specimens toconfirm 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] onthe MAIN MENU. The SPECIAL PROTOCOLS screen is discussed in the nextsection.

WARNING Consider all clinical specimens and controls, calibrators, etc. that contain human bloodor serum as potentially infectious. Use established, good laboratory working practiceswhen handling these samples. Wear gloves, lab coats and safety glasses and followother biosafety practices as specified in the OSHA Bloodborne Pathogen Rule or otherequivalent 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 maintenanceprocedures. Powder from the gloves may cause instrument problems.

Maintenance Chapter 9


9140214 Rev DCJune 1993

Following outlined maintenance schedules minimizes operational problems with theCELL-DYN 1600. The recommended intervals are based on the analyzer operating inlaboratories that process samples from a general patient population. The intervals areaffected by the volume of samples processed, the workload schedule, the operatingenvironment, and the patient population that is analyzed. Each laboratory must assessits own situation and modify these recommended intervals as necessary. Overduemaintenance is usually indicated by imprecision of one or more of the directlymeasured parameters. This imprecision is due to carryover or dilution/samplinginconsistencies. If this occurs on more than a random basis, perform the appropriatemaintenance more frequently than indicated.

Special Protocols Menu

The SPECIAL PROTOCOLS screen is the main screen used during maintenanceprocedures. It is accessed from the MAIN MENU by pressing [SPECIALPROTOCOLS].

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.



As Required (for troubleshooting or corrective action)

See the Nonscheduled Maintenance section for maintenance frequency.

1. Supplemental aperture cleaning (page 9-11)

2. Aperture plates cleaning (page 9-13)

3. Diluent syringe cleaning (page 9-16)

4. Sample syringe cleaning (page 9-19)

5. Sample aspiration probe interior cleaning (page 9-22)

6. HGB flow cell manual cleaning (page 9-24)

7. Vent line cleaning (page 9-26)

8. Accumulator draining and cleaning (page 9-27)

9. Preparing the analyzer for a prolonged period of non-use or for shipping (page9-28)

10. Aspiration probe removal and replacement procedure (page 9-29)

Daily Maintenance Procedures

Daily Shutdown Procedure

1. At the MAIN MENU, press [SPECIAL PROTOCOLS]. A new screen andnew labels appear.


3. Press [DAILY SHUTDOWN] to begin this cycle. <Process Active> appearson 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 therisk of burning the screen. If the instrument will not be used again within 24 hours,turn the power OFF.



9140214 Rev DCJune 1993

To prepare for prolonged shutdown:

When the power will be turned OFF for more than 72 hours, perform the followingprocedure:

1. Remove the tubing from the lyse reagent container.

2. Perform the lyse inlet tube rinsing procedure. See the Monthly Maintenancesection.

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 thelyse 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


2. Press [AUTO CLEAN] to begin this cycle.

3. Place the vial of undiluted enzymatic cleaner concentrate under the sampleprobe.

4. Press [START CLEAN]. <Process Active> appears on the screen. Thecomplete cycle takes approximately 11 minutes.

5. When the cycle completes, press [MAIN] to return to the MAIN MENU.



6. Run background counts until acceptable results are obtained for allbackground parameters.

7. Run commercial controls or QC specimens to confirm the proper performancebefore running any unknown specimens.


Aspiration Probe Exterior Cleaning

Materials Required

CELL-DYN Enzymatic Cleaner (at room temperature)Gauze pad/DYN-A-WIPETM

Distilled water

Procedure

During each run cycle, the wash block rinses whole blood from the outside of theaspiration probe. However, routinely clean and disinfect the outside of the probe toensure 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 ofthe probe several times with a gauze dampened with diluted enzymatic cleaner.

2. Wipe the outside of the probe with a gauze dampened with distilled water.

OR

Run a background to rinse the probe.




9140214 Rev DCJune 1993

Closed Sampler Auto Clean

Materials Required

CELL-DYN Enzymatic Cleaner (at room temperature)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 3/4full with cleaner.

2. Wipe the top of the Vacutainer tube with a lint-free towel to remove any excesscleaner and insert the stopper.

NOTE Enzymatic cleaner is extremely slippery and any cleaner on the stopper or the top ofthe Vacutainer tube can cause the stopper to come off.


4. Confirm that the stopper is securely inserted on the Vacutainer tube containingthe cleaner. Invert the tube and insert it into the closed sampler holder.

5. Press [START CLEAN]. <Process Active> displays on the screen. The ClosedSampler 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 performancebefore running any unknown specimens.




Closed Sampler Holder Cleaning

Materials Required

CELL-DYN Enzymatic Cleaner (at room temperature) or 5% sodium hypochloriteCotton tip applicatorLint-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 spilledblood or cleaning fluid from inside the holder. A cotton tip applicator can also be usedto clean the inside of the tube holder.

WARNING The tube holder contains a needle that presents a potential for injury when the operatorplaces 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 withcleaner.



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 theinner well and clean the inner surface.

7. Press [CLEAN SAMPLER]. <Process Active> appears on the screen.






Monthly Maintenance Procedures

Lyse Inlet Tubing Rinsing

Materials Required

Medium size beakerDeionized water

Procedure

Replace the lyse pump tubing with the spare lyse pump replacement tubing at leastevery 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 DailyMaintenance Procedures, To prepare for prolonged shutdown, for additional steps.

1. Remove the lyse tubing from the lyse reagent container and place it into acontainer of warm deionized water.



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 airthrough the tube.

A. To continue operation immediately:

1. Reinsert the tube into the lyse reagent and press [CLEARALARM]. Watch the Lyse Inlet tubing to verify lyse flow.



2. Perform 2 or 3 lyse prime cycles by pressing [LYSE PRIME].


4. Run commercial controls or QC specimens to confirm properperformance before running any unknown specimens.


B. To prepare for prolonged shutdown (power OFF for over 72 hours):

1. Turn MAIN power switch OFF.

2. Perform Step 3, Chapter 9, Maintenance, Daily Maintenance Procedures, Daily Shutdown, To prepare for prolonded shutdown, to complete shutdown procedure.

Rear Fan Filters Cleaning

Materials Required

Lint-free towels

Procedure

Rear cover fan filters are used to clean air passing through each of the rear fans. Cleanthem monthly to maintain a constant and unrestricted air flow. More frequent cleaningis 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 filtercounterclockwise 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 eachone.

5. Blot dry each filter with lint-free towels.




6. Reinsert the cleaned filter into the bracket.

7. Turn the power switch to ON. After the analyzer is initialized, press [RUN] tocontinue.


Nonscheduled Maintenance Frequency

Procedure Frequency

Supplemental When Auto Clean has not cleared a restriction or anAperture 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 haveCleaning 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 theProbe Interior source of imprecision.Cleaning

HGB Flow Cell When Auto Clean has not cleared away a restriction or anManual Cleaning organic build-up is suspected of causing any of the

following:1. Elevated HGB results2. HGB imprecision

Vent Line Cleaning When the vent line is restricted and prevents theformation of a proper meniscus in the metering tube.


Procedure Frequency


Vent Line Cleaning When the vent line is restricted and prevents the formationof a proper meniscus in the metering tube.

Accumulator 1. When the alarm indicates that the accumulator isDraining 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 WBCapertures, or when there is a marked increase in the RBC and/or WBC count timesthat cannot be solved by normal auto cleaning. If this procedure does not solve theproblem, remove and clean the aperture plates.

1. Ensure that the instrument is in the RUN mode and <READY> is displayed inthe Status Box.

2. Remove the upper front cover.

3. Carefully pour the 50% cleaning solution into the pre-mix cup.

4. Carefully pour 5 mL of 5% sodium hypochlorite into the RBC bath.

5. Replace the upper front cover.

6. Wait two minutes to allow the pre-mix cup to soak.

7. After the soak period, press [SPECIMEN TYPE].



9140214 Rev DCJune 1993

8. Press # key on the keyboard. The GAIN ADJUST screen displays. Thecleaning solution in the pre-mix cup is transferred to the WBC bath. Bothbaths 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 toaspirate the cleaning solution through the RBC and WBC apertures. If a<FLOW ERROR> or <CLOG> message displays, ignore it and continue torun the three counts.

NOTE DO NOT use [CLEAR ORIFICE] because it will drain the cleaning solution from thecups.

10. Press [SPECIMEN TYPE].

11. Press [NORMAL BACKGRND].

12. Press [CLEAR ORIFICE] to reset the Running Average program and drain thebaths.




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



Figure 9-1 Location of Dilution Baths

Aperture Plates Cleaning

Materials Required

CELL-DYN Enzymatic Cleaner (at room temperature) or 5% sodium hypochloriteSample vialSmall 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 theright of the probe. Locate the WBC bath to the left of the pre-mix cup. (SeeFigure 9-1.)


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



9140214 Rev DCJune 1993

Figure 9-2 Aperture Plate Installation

4. Swing the red tagged plate holder (which holds the plates securely in place) tothe right. (See Figure 9-2.)

5. Grasp the RBC/PLT aperture plate and pull it straight out from the transducerassembly 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 suitablecontainer and add 40 drops of enzymatic cleaner (warm water enhancesenzyme action).

OR

Dispense 15 mL of water into a beaker or suitable container and add 5 mL of5% sodium hypochlorite.

NOTE Diluted enzyme cleaner or sodium hypochlorite are most effective when they areprepared fresh each time this procedure is done.

8. Clean debris from each aperture plate by rotating the camel hair aperture brushprovided in the accessory kit.

WARNING Use only the brush provided. Use of other items or brushes will damage the apertureplate.

9. Place each aperture plate into the beaker of cleaning solution prepared in step7. Completely immerse each plate in the cleaning solution. Allow the plates tosoak for AT LEAST 5 minutes and NO LONGER than 15 minutes.

10. Remove each aperture plate from the cleaning solution and thoroughly rinse itwith a fine stream of deionized water.



To Reinstall the RBC/PLT Aperture Plate

The RBC/PLT aperture plate is identified with "R/P" etched in the plate and isinstalled 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 ofthe edge being inserted into the bath.

2. Insert the aperture plate into the slot between the two sections of the RBC/PLTdilution 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 tosecure the plate in place. (There will be a slight resistance as you replace thered lever.)

NOTE Be sure both the RBC/PLT and the WBC aperture plates are installed before fillingthe baths.

To Reinstall the WBC Aperture Plate

The WBC aperture plate is identified with "WBC" etched in the plate and is installedin 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 theedge being inserted into the bath.

2. Insert the aperture plate into the slot between the two sections of the WBCdilution 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 tosecure the plate in place. (There will be a slight resistance as you replace thered lever.)

NOTE Be sure both the RBC/PLT and the WBC aperture plates are installed before fillingthe 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 theMAIN MENU.



9140214 Rev DCJune 1993


4. Run commercial controls or QC specimens to confirm proper performancebefore running any unknown specimen.


Diluent Syringe Cleaning

Materials Required

Large basinDeionized water

Procedure

1. Obtain a large basin or suitable container to hold and soak the syringe. Add 2to 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. Thediluent syringe is the large (10 mL) syringe. The sample syringe is the small(100 FL) syringe.


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



Figure 9-3 Diluent Syringe

6. Remove the large thumb nut at the bottom of the plunger by holding thecalibration block with one hand and turning the large thumb nut clockwise(when viewed from above). (See Figure 9-3.)

7. Press [RESTORE SYRINGE] to move the black plunger holder down andallow 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 themcounterclockwise 2 complete turns. Pull the holder block away from thesyringe to prevent breakage of the luer lock connector. Gently pull the syringeglass barrel towards you to ensure that it is completely free of the front andback sections of the syringe holder block.

9. Completely remove the small thumb nuts and front section of the holder block.



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10. Hold the syringe by the glass barrel and TURN IT CLOCKWISE (whenviewed 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 waterprepared in step 1. Allow it to soak for 1 to 2 minutes to dissolve accumulatedsalt deposits.

13. Pull the white plastic stopper out of the barrel of the syringe. Pour warm waterinto the barrel from the bottom of the syringe.

WARNING Do not pull down, on, or otherwise move the plunger. Never push or pull on theplunger when the syringe is dry.

14. Remove the plunger from the barrel while the syringe is still immersed in warmwater. Let the barrel and plunger soak in warm water for 5 minutes. Removeand 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 andthe 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 thumbnuts removed earlier. Install the thumb nut with the smaller diameter facingupward. Tighten the thumb nuts finger-tight with the beveled edge towards theholder. Do not overtighten.

18. Press [CLEAN DIL SYRINGE] to move the plunger up. Secure it in theplunger holder with the large thumb nut removed earlier. Install the thumb nutwith the smaller diameter facing up. Tighten the large thumb nut to finger-tightwhile holding the calibration block. Do not overtighten.

NOTE A small gap between the plunger holder and the thumb nut is normal.



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 thesyringe action to make sure it fills and dispenses completely.

22. Run commercial controls or QC control specimens to confirm properperformance before running any unknown specimens.


Sample Syringe Cleaning

Materials Required

Large basinDeionized water

Procedure


2. Press [CLN SAMPL SYRINGE].

3. Unscrew the bottom of the sample syringe by turning the bottom of the plungercounterclockwise (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 (whenviewed from above).

6. If there are saline crystals around the collar of the syringe, soak the entiresyringe in warm water for 5 minutes. Then, gently pull the plunger rodcompletely out of the barrel and allow both pieces to soak for a few minutes.

WARNING Do not touch the tip of the plunger with your hands.



9140214 Rev DCJune 1993

Figure 9-4 Sample Syringe

7. Rinse the syringe in deionized water and reassemble. If the syringe needs to bereplaced, a new syringe may be installed. For complete instructions, see thenext section.

NOTE Do not push or pull on the plunger when the syringe is dry.



To Reinstall or Replace the Sample Syringe

1. Push the plunger in all the way. Draw deionized water into the syringe so thatthe 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 andredraw water into the syringe. This procedure may have to be repeated severaltimes to remove the air bubbles.

2. Screw the syringe tip into the fitting on the instrument by turningcounterclockwise (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 thestage.

4. Press [RESTORE SYRINGE].

5. Press [CLN SAMPL SYRINGE], then press [RESTORE SYRINGE]. Watchfor air bubbles.

If air bubbles are present, press [CLN SAMPL SYRINGE] and [RESTORESYRINGE] again. Repeat this process until there are no air bubbles.

6. When the syringe is operating properly and there are no air bubbles, press[MORE] twice. A new screen and new labels appear.

7. Press [REAGENT PRIME] to prime the instrument before operating.






9140214 Rev DCJune 1993

Figure 9-5 Sample Aspiration Probe Assembly

Sample Aspiration Probe Interior Cleaning

Materials Required

SyringeSample cupDeionized waterCleaning 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" straightconnector until it is free of the probe. (See Figure 9-5.)

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.



5. Using a syringe filled with deionized water, rinse the probe several times fromthe top.

6. Reinsert the tubing into the probe and connector.





9140214 Rev DCJune 1993

HGB Flow Cell Manual Cleaning

Materials Required

Syringe cup (10 to 20cc with at least 3" long silicon tubing attached to tip)Cleaning solution (equal parts of 5% sodium hypochlorite and water)Wire solenoid valve-pullerDeionized 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 topblack 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 entrancepoint into the flow cell.

5. Disconnect the tubing on the right side of the T-fitting and attach a cleaningsolution-filled syringe to the open end of the T-fitting. (See Figure 9-6.)

6. Attach the wire puller to pinch valve #26.

7. While holding the syringe base with your left hand, pull open valve #26 withyour 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 ensureoptimum rinsing action. Leave the solution in the flow cell for 3 to 5 minutes.

11. Remove the syringe.

12. Drain the solution from the flow cell by pulling open valve #26.

13. Using deionized water, perform the same syringe injection procedure (steps 7through 12) to flush out the solution thoroughly.



Figure 9-6 HGB Flow Cell Manual Cleaning

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.





9140214 Rev DCJune 1993

Vent Line Cleaning

Materials Required

Sample vials OR2 small beakersDeionized water

Procedure

1. Locate the vent lines on both sides of the flow panel. Follow them to wherethey 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.




Accumulator Draining and Cleaning

Materials Required

Large syringeLarge beakerDeionized water

Procedure

1. Turn the analyzer OFF.

2. Locate and unclamp the accumulator tubing beneath the lyse pump assemblyon 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 thesyringe 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 allbackground parameters.




9140214 Rev DCJune 1993

Preparing the Analyzer for a Prolonged Period of Non-Use or for Shipping

Materials Required

Deionized waterCardboard disk drive protectorDisinfectant (cleaning solution); 1 part 5% sodium hypochlorite added to 9 parts deionized waterLarge beakerPlastic bag

Procedure

Salt deposits and reagent residue may damage the flow system if not removed beforethe CELL-DYN 1600 is stored (idle for two weeks or longer) or shipped.



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 onthe upper left flow panel.

9. Remove each diluent and detergent inlet tube from its normally closed (blackoctagon) valve on the lower left side panel.

10. Remove the lower left side panel inlet and outlet tubing. The waste line shouldbe 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 withdisinfectant.

11. Remove the diskette from the disk drive and insert the cardboard disk driveprotector into the drive.

12. Remove the power cord from the outlet receptacle and rear cover connector.Place it in the accessory kit.



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 notdown, press [RUN] to lower it.

2. Hold the 1/32" silicone tubing and carefully pull up on the 1/16" straightconnector 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 thesesystems, 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 #4Allen screw in the probe holder.

B. Loosen the screws located on top of the wash block that hold theO-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 ofthe wash block. The probe collar determines the proper probe alignment and is factoryset. 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 withthe curved portion down.

NOTE For older models, tighten the Allen screw on the probe holder.



9140214 Rev DCJune 1993

7. Hold the probe to steady it and insert the 1/16" straight connector completelyinto the 1/32" silicone tubing.

8. Reinstall the upper front cover.




Chap

ter 9M

aintenance

CE

LL

-DY

N®

1600 Operator's M

anual9-31

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pril 1996

Maintenance

Chap

ter 9

9-32C

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L-D

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® 1600 O

perator's Manual

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pril 1996

Chapter 10 Troubleshooting


Troubleshooting

Introduction This chapter gives instructions for identifying, troubleshooting, and correctinginstrument problems. The CELL-DYN 1600® continuously monitors the status of thesystem and displays pertinent information in the status box. If a problem is detectedwithin 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 DIAGNOSTICSMENU screens when the instrument is initialized and primed. These keys enable theoperator or service representative to obtain information and execute programs thatassist in troubleshooting and to identify corrective action.

When some keys are pressed, the message <FOR SERVICE USE ONLY> isdisplayed. The data these keys provide are meaningful only to trained field engineersand are not useful to the operator. If these keys are pressed inadvertently, the systemmay 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 servicepersonnel to review or print the current system status.

Fault Report [FAULT REPORT] displays a new screen that allows the operator or servicepersonnel to review or print the current fault status. Whenever the message <NOTREADY. SEE DIAGNOSTICS> is displayed in the system status box, it is directingthe 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.

Troubleshooting Chapter 10


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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 performadditional diagnostics to assist in troubleshooting. This key performs the samefunction on all diagnostic menus.

Printer Output [PRINTER OUTPUT] allows the operator to print any screen by turning the printeroutput on before pressing another screen label. This also toggles the printer outputOFF. 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 screenkeypad labels and the procedures to be performed. This key performs the samefunction on all menus.

Main [MAIN] takes the operator back to the MAIN MENU and performs the same functionon all diagnostic menus.

When [MORE] is pressed, the second of four DIAGNOSTICS MENU screens isdisplayed. 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, allmotors 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.



Count Test [COUNT TEST] is used to run a specimen and to display the count test data. Theuser is directed to place the specimen under the probe and to press [START]. Thecount test can also be used in the pre-dilute mode.

Code data relating to specific cycle functions, raw measurement data, and flow counttime 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 16channels. For example, line 1 data are for channels 1 to 16, line 2 data are for channels17 to 32, etc. Each size channel equals 1.367 femtoliters.

RBC Histogram [RBC HISTOGRAM] is used to print the red cell count (numeric) data accumulatedin 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. Eachsize channel equals 1 femtoliter.

PLT Histogram [PLT HISTOGRAM] is used to print the platelet count (numeric) data accumulated ineach of 256 size channels. Each line contains data for 16 channels. For example, line 1data are for channels 1 to 16, line 2 data are for channels 17 to 32, etc. Each sizechannel equals 0.1367 femtoliters.

The histograms are displayed as numeric data and printed as graphic curves on thegraphic printer. Alphanumeric data are printed if a ticket printer is connected to thegraphic printer port.

Smoothing Off [SMOOTHING OFF] is used to change the histogram display status. Whensmoothing 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 toON.

When the status is ON and a histogram key is pressed, normalized and threshold-edited histogram data are shown. The number of the peak channel is also shown.



9140214 Rev DCJune 1993

When [MORE] is pressed, the fourth of four DIAGNOSTIC MENU screens isdisplayed. 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 performadditional diagnostics to assist in troubleshooting. This key performs the samefunction on all diagnostic menus.

Printer Output [PRINTER OUTPUT] allows the operator to print any screen by turning the printeroutput ON before pressing another screen label. This also toggles the printer outputOFF. 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 screenkeypad labels and the procedures to be performed. This key performs the samefunction on all menus.

Main [MAIN] takes the operator back to the MAIN MENU and performs the same functionon all diagnostic menus.



Troubleshooting Guide

The Troubleshooting Guide is designed to assist the operator in identifying andresolving instrument problems. Instructions are also given for obtaining technicalassistance from the Abbott Customer Support Center.

Introduction Good troubleshooting skills are learned by using a logical, step-by-step approach toproblem solving. The first step in the process is understanding normal instrumentoperation and preventative maintenance. A good, working knowledge of the instrumentis essential for identifying and resolving operational problems.Logical troubleshooting may be divided into three steps:

1. Problem Identification2. Problem Isolation3. Corrective Action

Step 1, Problem Identification, is not only identifying what is wrong but also notingwhat is right. The investigation should identify the problem area and eliminate areasthat are working correctly. Once this is done, the troubleshooting process movesquickly to the next step.

Step 2, Problem Isolation, further classifies the problem. Instrument problems aregenerally 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 authorizedservice representative. Measurement problems are generally operator correctable. Thiscategory is further subdivided into problems related to sample handling, maintenanceor 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, normaloperation can quickly resume.

This Troubleshooting Guide is designed to enhance the troubleshooting process byproviding information to assist in problem identification, isolation and correctiveaction.



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Obtaining Technical Assistance

Technical Assistance is obtained by calling the Abbott Customer Support Center. It isimportant to provide the Customer Support Specialist with a clear and detaileddescription of the problem. When assistance is needed, please be prepared to providethe following information for the Customer Support Specialist:

1. Instrument model number2. Serial number of the analyzer and software version in use3. 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 use5. Examples of sufficient data to facilitate the discussion



Troubleshooting Guide

NOTE Generally, conditions that are instrument- or reagent-related will occur on all samples, includingcontrols. Therefore, it is important to confirm instrument performance by rerunning controls and/oradditional patient specimens.

Table 10-1. Troubleshooting Guide

Condition Probable Cause Required Action

> > > >appears in placeof result.

Data exceeds Display and For RBC or PLT: Dilute 0.5 mL aliquot of well-mixed wholePrint capacity. blood with 0.5 mL diluent (1:2 ratio). Close the container and

invert it 10 to 15 times to mix. Run the specimen as usual.Multiply the RBC, HGB, HCT, and PLT result by 2 to obtaina reportable value.

For WBC or PLT: Dilute 0.5 mL aliquot of well-mixed wholeblood with 0.5 mL of diluent (1:2 ratio) or 1 mL (1:3), 1.5 mL(1:4), or 4.5 mL (1:10) of diluent as required. Close thecontainer and invert it 10 to 15 times to mix. Run thisspecimen as usual. Multiply each WBC and PLT result by 2,3, 4, or 10 (per ratio of diluent to blood used above) to obtain areportable value.

> > > >appears in placeof RBC or PLTresult.

Wash block and probe Perform the probe removal and replacement proceduremisaligned. described in Chapter 9, Maintenance. Confirm the probe is

properly installed and aligned. Obtain technical assistance.

Abnormal or Dirty HGB flow cell. Perform the hemoglobin flow cell manual cleaning procedureerratic HGB, as described in Chapter 9, Maintenance.MCH, and/orMCHC results. Lipemic sample or Specimen exceeds limitations of the procedure. See Chapter 5,

sample with WBC result Operating Instructions.above 50,000/FL.

Circuitry malfunction. Go to the diagnostics screen and press [PRINTER OUTPUT].Press [RAW DATA]. Data display and print. Check the resultsfor hemoglobin error. As required, obtain technical assistance.




Table 10-1. Troubleshooting Guide (continued)


Background data Interference from other Use dedicated power source or line voltage regulator; relocateare unacceptable. electrical devices. instrument in an area free from interfering devices.

Cold reagents—less than Allow reagents to warm. Rerun background check. If the59EF or 15EC. background data are not acceptable, go to the next probable

Contaminated bath and/or Perform the Auto-Clean procedure described in Chapter 9,aperture. Maintenance.

Contaminated diluent or Perform the procedures from Chapter 9, Maintenance, todetergent. prepare the unit for shipping. Use a 1:4 dilution of 5% sodium

Contaminated lyse. Perform the lyse inlet tube rinse procedure described in

Diluent frozen in Replace with a new lot number or different shipment.shipment.

Malfunctioning circuitry. Obtain technical assistance.

cause.

hypochlorite to water for cleaning and disinfecting the flowsystem. Repeat the procedure using distilled water. Rinse andrefill the flow system with freshly opened containers of diluentand detergent.

Chapter 9, Maintenance. Install a freshly opened container oflyse.

The message Debris, fibrin clots, or Press [CLEAR ORIFICE] to backflush the aperture and reset the<CLOG> is protein build-up is clog limit. If the situation occurs repeatedly, go to the SPECIALdisplayed in place restricting fluid flow PROTOCOLS MENU and run the Auto-Clean procedure.of Count Time. through the aperture. Perform manual aperture cleaning. Check the sample for fibrin

Flow system blockage Remove the detergent inlet tube from the flow panel normallyresulting 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 thedetergent normally closed diluent tube. If the situation occurs repeatedly, perform thevalve, or reagent particles maintenance procedures to prepare the unit for shipping. Use amay be in the flow panel. 1:4 ratio of 5% sodium hypochlorite to water.

clots or red cell agglutination. Redraw the specimen asrequired. Rerun the specimen if required.





The message Reagent with different Install only Abbott-recommended reagents as described in<DETERGENTEMPTY> isdisplayed.

conductivity was Chapter 2, Installation.installed.

Detergent is not being Exercise the tubing in normally closed valves. (Refer to Tubepulled into flow system. and Diluent Syringe Installation in Chapter 2, Installation.)

NOTE Stated performance does not apply when other reagents are installed.

The message Reagent with different Install only Abbott-recommended reagents as described in<DILUENTEMPTY> isdisplayed.


Diluent is not being Exercise the tubing in normally closed valves. (Refer to Tubepulled into flow system. and Diluent Syringe Installation in Chapter 2, Installation.)

Diluent syringe thumb nut that the large knurled thumb nut on the bottom of the syringe ishas vibrated loose. fully tightened—if not, tighten finger tight.


With one hand holding steady the calibration block, confirm

The message Air bubbles are trapped Press [CLEAR ORIFICE] to backflush the aperture and reset the<FLOW ERR>is displayed inplace of CountTime.

in the dilution baths. clog limit. Rerun the specimen. If the situation occurs

Malfunctioning pinch Raise the upper front cover and remove the lower front covervalve. to gain access to the flow panel. Examine wash flow panel

repeatedly, go to the SPECIAL PROTOCOLS MENU and press[DRAIN] to drain the liquid from each bath. When the processis complete, press [REFILL BATHS]. This process removes anybubbles trapped inside the baths.

pinch valves to determine if each valve's press “T” can bemoved—pushed in or pulled out when the valve is closed.Obtain technical assistance as required.






The message Aperture plates installed Check plate installation. Confirm that the aperture plate<FLOW ERR>or <CLOG> isdisplayed in placeof both CountTimes.(WBC/RBC).

in wrong baths. marked “R/P” is installed in the RBC/PLT bath located to the

Insufficient wetting of Remove the upper and lower front covers to gain access to thedetergent reagent to form flow panel. Press the white button (replaces touch plate) belowa good meniscus in the the aspirate probe. Observe fluid flow and meniscus formationmetering tube. in each metering tube. When meniscus formation is poor,

Insufficient liquid in the access to the flow panel and syringe panel. Press the touchbath. Air is drawn plate. Observe the action of the diluent syringe and the fluidthrough the aperture. flow in and out of each bath. If the syringe action is not

Flow system leak.

Damaged aperture. objective lens with external light source. If damage is observed,

right of the probe. Confirm that the aperture plate marked“WBC” is installed in the other bath.

prepare the analyzer for shipping as described in Chapter 9,Maintenance. Rinse the flow tubes and install a freshly openedcontainer of detergent. As required, obtain technical assistance.

Remove the upper front cover and open the left panel to gain

complete, perform the diluent syringe cleaning proceduredescribed in Chapter 9, Maintenance. As required, obtaintechnical assistance.

Check the system for leaks or cracks.

Check the aperture under a microscope using a low power

obtain a replacement aperture plate. Verify calibration afterreplacement.

INITIALIZED Power-on initialization The unit is NOT primed. To run specimens, press [RUN].cycle was performed.





Keypad selection Computer busy Refer to the screen for current status messages; counting, etc.or entry not performing a functionaccepted. that prevents screen label

selection.

Data being transmitted toprinter or computer.

Keypad entry not allowedfor this screen.

Computer, keypad, and/or ON. If the situation is not corrected, obtain technicalcircuitry malfunction. assistance.

None required.

None required.

Turn the power OFF. Wait 30 seconds. Turn the power back

The message Reagent with different Install only Abbott-recommended reagents as described in<LYSEEMPTY> isdisplayed.


No liquid was detected by Confirm that the end of the lyse tube is immersed in reagent.the internal lyse sensor. When the container is empty, replace it with a fresh container

Lyse pump tubing is wornout. Replace lyse pump tubing if there are signs of deterioration or

Lyse inlet tubing isclogged. Perform lyse inlet tubing flush procedure.


of lyse. Press [CLEAR FAULT].

if the tubing is over 3 months old.

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



9140214 Rev DCJune 1993



No power. Power cord is loose or not Confirm that the power cord is inserted securely into both thesecurely connected to the rear panel connector and wall outlet(s). Confirm that the plugunit or wall socket. prongs are not bent.

Power switch is OFF.

No voltage or wrongvoltage at the lab power Confirm that the fuse and circuit breaker at facility (site) arereceptacle. acceptable. Confirm that the analyzer's rear panel voltage

Defective power switch. Obtain technical assistance.

Instrument malfunction. Obtain technical assistance.

Move the rear panel power switch to ON.

selector PCB and fuse are correct for the power provided.

No screen The screen brightness Turn the brightness knob clockwise to adjust brightness.display. adjustment knob is turned

down.

Incoming power Turn power OFF, wait 30 seconds, turn power back ON.fluctuation.

No screen labels. Cycle in process but not None. Refer to the screen for current status.complete.

Incomplete data entry. To abandon the unfinished operator entry process andredisplay the screen labels, press [ENTER].

QC specimen Improper mixing or Refer to Chapter 7, Quality Control, for the proper handling ofresults exceed handling of the QC QC specimens.acceptable limits. specimen.

Dilution error. Rerun specimen. If the situation occurs again, perform the

Insufficient or no dilution Remove the upper front cover. Press the touch plate. Observemixing. the bubble mix in each bath. As required, obtain technical

Auto-Clean procedure and/or the diluent syringe cleaningprocedures described in Chapter 9, Maintenance.

assistance.

Run cycle will Defective diskette or Turn the power switch OFF. Replace the system diskette withnot stop. diskette drive. the spare supplied with the analyzer. Obtain technical

assistance.





Specimen will not Fibrin or debris is in the Check the specimen for fibrin clots or red cell agglutination.aspirate. specimen aspiration Redraw the specimen as required. Check the probe for fibrin

probe. clots, salt deposits, etc. Remove and clean the probe or replace

Vacuum or circuitry Obtain technical assistance.malfunction.

it.

STANDBY No run cycle was Press [RUN] to run auto-startup, prime the unit, and perform aactivated for 4 hours. The background check.auto-shutdown cycle wasactivated, placing the unitin standby.

The message Instrument hardware Go to the DIAGNOSTICS MENU screen. A message<UNINITIAL-IZED, SEEDIAGNOS-TICS> isdisplayed.

malfunction detected pertaining to the computer-detected malfunction is displayedduring initialization cycle. with the required operator action. As required, obtain technical

assistance.

The message Liquid level in the waste Remove the waste stopper assembly and empty the container.<WASTEFULL> isdisplayed.

container has tripped the Press [CLEAR FAULT] to continue. Make sure liquid is wipedsensors. from stopper and top of bottle to ensure good seal.

Waste sensor plug is to continue. Turn power OFF. Wait 10 seconds, then turnnot inserted completely in power ON.lower left side panelreceptacle. An audibletone sounds to alert theoperator.

Defective component.

CAUTION Liquid is a possible biological and chemical hazard. Follow good laboratory safety practices.

Reinsert the plug into receptacle, then press [CLEAR FAULT]

Obtain technical assistance.

Waste full, no Waste sensor plug dirty. Clean plug with alcohol and reinsert fully.messagedisplayed. Loose wire in waste cap. Obtain technical assistance.



9140214 Rev DCJune 1993



WBC and/or No lyse reagent added. Remove lyse tube from flow panel normally closed valve andHGB data are Pinched or cracked lyse roll it between your fingers. If it remains flat, replace theinvalid. tubing. Malfunction of tubing. Insert the tube in the valve. Go to the SPECIAL

lyse pump or pinch valve. PROTOCOLS screen and press [LYSE PRIME]. Observe theaction of the lyse pump (lower left). Confirm that lysedispenses into the WBC bath during the prime cycle. Asrequired, do the lyse tubing rinse procedure described inChapter 9, Maintenance, or obtain technical assistance. Verifylyse volume.

X-B data are out Dirty HGB flow cell. Perform the hemoglobin flow cell manual cleaning procedurefor MCH and/or as described in Chapter 9, Maintenance.MCHC.

Amount or timing of lyse Perform the lyse inlet rinsing procedure described in Chapter 9,addition not optimal. Maintenance. Check tubes for cracks and leaks. As required,

obtain technical assistance.

X-B data are out Dirty aperture. Clean aperture plate as described in Chapter 9, Maintenance.for MCV. As required, obtain technical assistance.

Chapter 11Chapter 11 PrintersPrinters

CELL-DYN7 1600 Operator's Manual 11-19140214 Rev DCJune 1993

Printers

Introduction The CELL-DYN7 1600 is configured with a graphics printer. The printer is set up toprint reports, including complete graphic information, on continuous tractor-feedpaper.

Graphics Printer This section gives a brief overview of Graphics Printer maintenance andtroubleshooting. Instructions for installation are given in the Printer Installationsection of Chapter 2, Installation. For a detailed description of the printercomponents and instructions on changing the ribbon and loading paper, refer to themanuals that accompany the printer.

The CELL-DYN 1600 software automatically controls and adjusts most printconditions. Occasionally, a few settings may need to be changed in the printersoftware for correct operation. If printing is not what you expect, refer to the printermanual for guidance in making adjustments. If you have additional questions orexperience any problems, call the Abbott Customer Support Center for assistance.

Troubleshooting Refer to the printer manuals for a list of the most common printer problems and howto solve them. If the problem is not resolved, contact the Abbott Customer SupportCenter for assistance.

NOTE If, during routine system operation, the message <PRINTER UNAVAILABLE> <PRINTER UNAVAILABLE>is displayed, check to see that the printer cable is securely connected to the datamodule, the printer power switch is turned ON, and that the Select indicator isilluminated. Press [PRINT] [PRINT]. If the message is still displayed, turn the printer powerOFF, wait about 5 seconds, turn the power ON again and press [PRINT] [PRINT]. If themessage is still displayed, there may be an internal printer error. Contact the AbbottCustomer Support Center for assistance.

Ticket Printer If ticket printing is desired for the CELL-DYN 1600, a second printer (known as theTicket Printer) can be connected to the system at the same time as the graphicsprinter. Instructions for the installation of both printers are given in the PrinterInstallation section of Chapter 2, Installation. Complete directions for customizingthe printout type and format are given in the Setup System Operation section ofChapter 2, Installation.

For detailed information about loading paper and changing the ribbon in the ticketprinter, refer to the manuals that accompany the printer. In particular, note theimportant safety instructions.

PrintersPrinters Chapter 11Chapter 11

11-2 CELL-DYN7 1600 Operator's Manual

9140214 Rev DCJune 1993

Printing Tickets To print tickets, the printer cable must be connected to the ticket printer connector onthe right side of the data module. (See Figure 2-1 for the location of theseconnectors.) Refer to the Customize Printout section in the Setup System Operationsection of Chapter 2, Installation, for instructions for customizing either type ofprintout.

Maintenance Every 6 months (or after about 300 hours of operation), use a clean, dry cloth to dustthe area around the carriage shaft and platen. Be sure to remove any loose particles ofpaper. Do not use solvents or strong detergents on the cabinet. Be sure to turn theprinter OFF before cleaning.

Troubleshooting Refer to the printer manuals for a list of the most common printer problems and howto solve them. If the problem is not resolved, contact the Abbott Customer SupportCenter for assistance.

NOTE If, during routine system operation, the message <PRINTER UNAVAILABLE> <PRINTER UNAVAILABLE>is displayed on the bulletin line, check to see that the printer cable is securelyconnected to the data module, the printer power switch is turned ON, and that theSelect indicator is illuminated. Press [PRINT] [PRINT]. If the message is still displayed, turnthe printer power OFF, wait about 5 seconds, turn the power ON again and press[PRINT][PRINT]. If the message is still displayed, there may be an internal printer error.Contact the Abbott Customer Support Center for assistance.

Chapter 12 CELL-DYN® 1600CS

CELL-DYN® 1600 Operator's Manual 12-19140214 Rev ECFebruary 1994

CELL-DYN 1600CSClosed 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 thismodule, the CELL-DYN 1600 must be fully operational. Refer to the followingchapters 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 analyzerdesigned for in vitro use in clinical laboratories. It is, in essence, theCELL-DYN 1600 with the added capability to aspirate specimens from a closedcollection 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 collectiontube and pumped to the sample container in the closed sampler module. Thespecimen probe then aspirates the proper volume from the sample container andperforms the WBC and RBC/PLT measurements described in the other chapters ofthis manual.

WARNING Consider all clinical specimens and controls, calibrators, etc. that contain humanblood or serum as potentially infectious. Use established, good laboratory workingpractices when handling these samples. Wear gloves, lab coats and safety glasses andfollow other biosafety practices as specified in the OSHA Bloodborne Pathogen Ruleor 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 maintenanceprocedures. 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 leftand attached to the CELL-DYN 1600 by a thumbscrew on the right side of themodule.

CELL-DYN® 1600CS Chapter 12



Figure 12-1 Closed Sampler

Figure 12-2 Internal Flow Panel

The front panel of the module includes the following components:

! A tube holder (2) for the closed collection tube. The holder contains a needleto 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'sinternal 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 themodule and swing the door out toward you.



The closed sample aspiration module internal flow panel includes the followingcomponents:

! Two peristaltic pumps located near the bottom of the module door. Next toeach pump is a pump tube holder and two tube stops. The tube stops aredesigned 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. Theinstrument must be operational before the closed sample aspiration module canfunction properly. The closed sample aspiration module is shipped with the internalflow panel peristaltic pump tubes and normally closed valve tubes removed.

1. Turn the thumbscrew on the right side of the module counterclockwise untilthe door swings open.

2. Pull the module door toward you.

3. Locate the peristaltic pumps, the pump tube holders, and the tube stopslocated 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 tubebetween 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 thetube and insert it into the valve opening. Work the tube back and forth gentlyuntil it is completely seated in the valve.

CAUTION Make sure the tubing is not crimped or pinched.




Figure 12-3 Tube Guide

Tube Guide Adjustment Procedure

The tube guide of the closed sampler module is factory set to accept 75 mm highVacutainer® tubes. As required, the tube guide can be adjusted to accept Vacutainertubes that are 100 mm high. An Allen wrench is included in the accessory kit for usein 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 andnut.

3. Insert the Allen wrench into the lower clamp nut and turn the wrenchcounterclockwise 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 holdthe 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.

Chapter 12Chapter 12 CELL-DYN® 1600CSCELL-DYN® 1600CS

CELL-DYN® 1600 Operator's Manual 12-12-559140214 Rev F—April 1996

10. Insert and remove the new size Vacutainer tube from five to ten times to confirmthat both clamp nuts are tight.

Overview of the Run Mode

Only specimens collected in a standard Vacutainer tube, either 75 mm or100 mm high, and containing EDTA anticoagulant can be run via the closed sampleaspiration module. The specimens should be no more than four hours old to provide themost accurate results for all parameters.

<CLS><CLS> appears on line 3 of the upper left RUN MENU. <C> <C> appears after the Sequence# in the data log and QC files to designate that the specimen was run via the closedsampler. The CELL-DYN 1600CS is ready to run samples in the closed sampleaspiration 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 opensample. 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 thebottom 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 runimmediately prior to running any patient specimens.

Verification and Calibration

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

CELL-DYN® 1600CSCELL-DYN® 1600CS Chapter 12Chapter 12


9140214 Rev F—April 1996

Closed Mode Calibration Verification

1. Confirm that the system has been properly calibrated in the open mode asoutlined in Chapter 6, Calibration.

2. Obtain a normal fresh whole blood sample. A full 7 mL tube is required. In anempty replicate file, run the sample five times in the open mode and five times inthe 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'sinstrument log book that closed mode calibration verification has beenperformed. No further action is required.

5. If one or more parameters do not meet this criteria, repeat the procedure using adifferent whole blood sample.

6. If the results from the second sample fail to meet the above criteria for anyparameter, contact the Abbott Customer Support Center for assistance.

Calibration Refer to Chapter 6, Calibration, regarding recommended guidelines for calibrationfrequency.

Materials Required

• A minimum of five different fresh whole blood samples. All parameter valuesshould be within the laboratory's normal range. Refer to sample requirements forfresh whole blood, Chapter 6, Calibration. Each sample must have sufficientvolume to be run three times in both the open and closed mode. Therefore, it isadvisable to select full 5 mL tubes.

• Calculator• Mode to Mode Verification & Calibration Worksheet



Procedure 1. Confirm that the background counts are acceptable and precision is withinestablished limits (see Chapter 4, System Specifications).

2. Confirm calibration of the open mode by running all three levels ofcommercial controls. Refer to the calibration procedure in the operator'smanual if open mode calibration is required.

3. Select two replicate files to be used for the determination of the mean valuefor 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 ofthe 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 ofthe second file.

B. Run each well-mixed sample (the same samples as in Step 4) two timesinto 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 allparameters are within the validation range, document in your laboratory'sinstrument log book that verification has been completed. Calibration is notnecessary and no further action is required. If any parameters requirecalibration, 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 DilutionFactors for the Open Sample and Closed Sample. The Dilution Factors areprovided 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) onworksheet section #3.

7. Use worksheet section #3 to calculate factors for the parameters that requirecalibration. 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 filein 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 allcalculations were correct and that the new factors were entered correctly.If no errors are detected, call the Abbott Customer Support Center forassistance.

Quality Control

Complete instructions for Quality Control are given in chapter 7.

The following procedure may be used to verify the performance of the ClosedSampler mode of operation.



Mode to Mode QC Verification

Good laboratory practice mandates that controls be run in all modes in which sampleswill be run. CELL-DYN control materials may be run in the Open or Closed mode onthose CELL-DYN Systems with two modes of operation. Patient samples can beassayed in the Open mode after verifying that CELL-DYN controls fall within thelaboratory's acceptable limits. These samples may then be used to verify the operation ofthe Closed mode. The following is a suggested procedure for using patient samples toverify the operation of the Closed mode.

Procedure 1. Run a minimum of two levels of control in the Open mode at the beginning ofeach eight hours of operation prior to running patient samples. Control samplesmust be run in the same manner as patient samples.

2. When control results are within the laboratory's acceptable limits, record theresults and process patient samples in the Open mode.

3. Select three normal patient samples from the Open mode run. Sample resultsshould 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 Modeverification.

NOTE Replicate files store only the absolute values for the three-part differential. If you wishto validate the differential percents (%LYM, %MID, %GRAN), you must manuallyrecord the values directly from the RUN SCREEN or from the printout of each controlrun. The differential percentage data taken from the individual control runs must be usedto manually calculate the mean differential percentages.

5. Run the first selected patient sample in the Open mode in the replicate fileconfigured for sample 1. Run the second and third samples in the Open mode intheir respective files.

6. Run the first normal patient sample in the Closed mode in the replicate fileconfigured for sample 1. Run the second and third samples in the Closed modein their respective files.

CELL-DYN® 1600CSCELL-DYN® 1600CS Chapter 12Chapter 12


9140214 Rev F—April 1996

7. Verify that the Closed mode results match the Open mode results within thelaboratory'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 establishedrange for all parameters. When the results are within the established range,record the difference between the Open and Closed mode results on the logsheetprovided and process patient samples in the Closed mode.

NOTE A Mode to Mode QC Verification logsheet is provided at the end of this section forrecording the differences. This logsheet may be duplicated as needed.

9. If results are outside the established range, contact the Customer Support Centerfor assistance.

Maintenance Complete maintenance instructions are given in Chapter 9. In addition to the OpenMode maintenance, the following Closed Sampler maintenance should be performedweekly:

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 Chapter9.

3. Check the peristaltic pump tubing and replace as needed.



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 100Open 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

%Bias

Validation RangeCal Not Required

Calibration RangeCal Needed

Calibration LimitDo Not Cal*

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 the Abbott Customer Support Center for assistance.




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 ClosedClosed Mode Mean Sample Dilution Factor

#3

Open Mode Closed Mode Closed Sample New Closed SampleMean ÷ 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 100Open Mode Mean

#4

Closed Mode Open Mode Open ModeMean* - Mean ÷ Mean X 100 = % Bias Range**

WBC - ÷ X 100 = # ± 2.00%

RBC - ÷ X 100 = # ± 1.25%

HGB - ÷ X 100 = # ± 1.25%

MCV - ÷ X 100 = # ± 1.25%

PLT - ÷ X 100 = # ± 3.50%

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

CELL-DYN 1600 Mode to Mode QC VerificationDaily Differences Logsheet

Month:____________ Instrument:_____________

DATE SAMPLE ID NO. WBC RBC HGB MCV PLT MPV LYM MID GRAN %LY %MID %GRAN TECH

S1:

S2:

S3:

S1:

S2:

S3:

S1:

S2:

S3:

S1:

S2:

S3:

S1:

S2:

S3:

S1:

S2:

S3:

S1:

S2:

S3:

AVG. DIFFERENCE

12-13

CELL-DYN® 1600 Operator's Manual Tables-19140214 Rev D — June 1993

TablesTable T-1: Potential Causes of Erroneous Results with Automated Cell Counters

PARAMETER CAUSES OF SPURIOUS INCREASE CAUSES OF SPURIOUS DECREASE

WHITE CELL COUNT (WBC) Cryoglobulin, cryofibrinogenHeparinMonoclonal proteinsNucleated red cellsPlatelets clumpingUnlysed red cells

ClottingSmudge cellsUremia plus immunosuppressants

RED CELL COUNT (RBC) Cryoglobulin, cryofibrinogenGiant plateletsElevated white cell count (> 50,000/µL)

Cold agglutininsClotted specimen (microclot)Hemolysis (in vitro)Polycythemia (increased RBC coincidence)Microcytic red cells

HEMOGLOBIN (HGB) Carboxyhemoglobin (> 10%)Cryoglobulin, cryofibrinogenHemolysis (in vivo)Elevated white cell countHyperbilirubinemia, severeLipemiaAbnormal plasma proteins

Clotted specimen (microclot)

HEMATOCRIT (PACKED CELLVOLUME - ANALYZER METHOD)

Cryoglobulin, cryofibrinogenGiant plateletsElevated white cell countHyperglycemia (> 600 mg/dL)

AutoagglutinationClotted specimen (microclot)Specimen hemolysis

HEMATOCRIT (PACKED CELLVOLUME - MANUAL METHOD)

HyponatremiaPlasma trapping

Excess EDTAHemolysis (in vitro)Hypernatremia

MEAN CELL VOLUME AutoagglutinationHigh white cell count (> 50,000/µL)HyperglycemiaReduced red cell deformability

Cryoglobulin, cryofibrinogenGiant plateletsHemolysis (in vitro)Microcytic red cellsSwollen red cells

MEAN CELL HEMOGLOBIN High white cell count (> 50,000/µL)Spuriously high hemoglobinSpuriously low red cell count

Spuriously low hemoglobinSpuriously high red cell count

MEAN CELL HEMOGLOBINCONCENTRATION

AutoagglutinationClottingHemolysis (in vivo and in vitro)Spuriously high hemoglobinSpuriously low hematocrit

High white cell count (> 50,000/uL)Spuriously low hemoglobinSpuriously high red cell count

PLATELETS (PLT) Cryoglobulin, cryofibrinogenHemolysis (in vivo and in vitro)Microcytic red cellsRed cell inclusionsWhite cell fragments

ClottingGiant plateletsHeparinPlatelet clumpingPlatelet satellitosis

TablesTables

Tables-2 CELL-DYN® 1600 Operator's Manual

9140214 Rev D — June 1993

Table T-2: Normal Values for Automated Blood CountersPARAMETER ADULT MALE

>18 YEARSADULT FEMALE

>18 YEARSCHILDREN

AT 1 MONTHCHILDREN

AT 2 YEARSCHILDREN

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(K/µL)

0.6 - 3.4 0.6 - 3.4 6.0mv 6.3mv 3.1mv

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(K/µL)

2.0 - 6.9 2.0 - 6.9 3.8mv 3.5mv 4.4mv

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 Differentialmv

denotes mean valueFor adult black males and females, normal WBC is 2.9 K/µL - 7.7 K/µLFor adult black males and females, normal RBC, HGB and HCT is 5% lessFor 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

TablesTables

CELL-DYN® 1600 Operator's Manual Tables-39140214 Rev D — June 1993

Table T-3: Anemia Classification Based on MCV and RDWMCV (LOW) MCV (NORMAL) MCV (HIGH)

RDW(NORMAL)

Non-anemic heterozygous thalassemiaChronic diseaseChildren

NormalChronic diseaseNon-anemic hemoglobin abnormalitiesNon-anemic enzyme abnormalitiesChronic lymphocytic leukemiaSplenectomyAcute blood lossChronic liver diseaseChronic myelogenous leukemiaCytotoxic chemotherapy

Aplastic anemiaHyperglycemiaChronic liver diseaseChronic myelogenous leukemiaCytotoxic chemotherapy

RDW(HIGH)

Iron DeficiencyHgb S-Alpha or Beta ThalassemiaHgb H

Early or mixed nutritional deficiencyAnemic hemoglobin abnormalitiesMyelofibrosisSideroblasticMyelodysplasiaChronic liver diseaseChronic myelogenous leukemiaCytotoxic chemotherapy

Folate or vitamin B12

deficiencySickle cell anemia (1/3 of cases)Immune hemolytic anemiaCold agglutininsPreleukemiaNewbornChronic liver diseaseChronic myelogenous leukemiaCytotoxic chemotherapy

Table T-4: Progressive Stages of Iron DeficiencySTAGE 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

TablesTables

Tables-4 CELL-DYN® 1600 Operator's Manual

9140214 Rev D — June 1993

Table T-5: Morphophysiologic Classification of Red Cell DisordersANEMIA MCV (LOW) MCV (NORMAL) MCV (HIGH)

HYPOPROLIFERATIVE DISORDERS:

RDW(NORMAL)

Chronic disease Chronic disease Aplastic anemia

NUTRITIONAL DISORDERS:

RDW(HIGH)

Iron deficiencySideroblastic

Early iron, folate, or vitamin B12 deficiencySideroblastic

Folate, or vitamin B12

deficiencySideroblastic

HEMOLYTIC DISORDERS: RDW is increased proportionally to degree of anemia.

RDW(NORMAL)

Thalassemia trait or carrier

AS, AC, non-anemic hemoglobinopathies

Chronic non-anemic enzyme or membrane defects

RDW(HIGH)

Thalassemia itermedia or H diseaseS-beta thalassemiaSS and alpha thalassemia

Hgb SS Hgb SS

ARTIFACTS: Histogram abnormal

RDW(HIGH)

Red cell fragments Red cell fragments post-transfusion

Cold agglutininsHyperglycemiaChronic lymphocytic leukemia

Source: Adapted from Bessman, Gilmer, and Gardner 1983

Table T-6: Result Abnormalities Caused by ArtifactsITEM 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

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