Abbott CELL-DYN 1600, CELL-DYN 1600CS hematology analyzer OPERATOR'S MANUAL
The CELL-DYN 1600 is a multi-parameter hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The instrument has two versions, the CELL-DYN 1600, which accepts specimens from open collection tubes only, and the CELL-DYN 1600CS, which accepts specimens in either open or closed collection tubes. The CELL-DYN 1600CS is equipped with an attached closed sample aspiration module referred to as the closed sampler. The closed sampler aspirates blood from a closed collection tube that has been inserted in the sampler module. Operating and maintenance instructions for the CELL-DYN 1600CS are described in the Addendum for the CELL-DYN 1600CS operation.
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$%%277 CELL-DYN® 1600 System OPERATOR’S MANUAL CD-TOC LIST NO: 92352-01 EXIT Click on item below: • • • • • • • • • • • • • • • ABBOTT LABORATORIES ABBOTT PARK, IL 60064 U.S.A. Table of Contents Introduction System Description Installation Principles of Operation System Specifications Operating Instructions Calibration Quality Control Precautions, Limitations, Hazards Maintenance Troubleshooting Printer Closed Sampler Module Appendices ENTIRE CONTENTS COPYRIGHT ABBOTT LABORATORIES 1993 PRINTED IN U.S.A. SEARCH BOOK TOC GO BACK Table of Contents Introduction Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i Proprietary Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i Abbott Instrument Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii Abbott Customer Support Center . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv Conventions Used in This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v Revision Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii Signature Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii Reference List of Trademarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix Part Number List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x 1. System Description Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Specimen Analyzer Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Data Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Flow Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Lower Left Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Upper Right Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Reagent System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Installation 1-1 1-1 1-1 1-2 1-3 1-4 1-6 1-8 1-8 1-9 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1 Initial Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1 Printer Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3 Tube and Diluent Syringe Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5 Flow Panel Inspection and Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8 Data Diskette Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10 Power On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10 Setup System Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11 Keypad Setups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14 Auto-Startup Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21 3. Principles of Operation Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sample Analysis Cycle Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . WBC Measurement Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . WBC Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RBC/PLT Measurement Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RBC Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CELL-DYN® 1600 Operator's Manual 9140214 Rev ECFebruary 1994 3-1 3-1 3-4 3-5 3-6 3-8 Table of ContentsC1 SEARCH BOOK TOC GO BACK PLT Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9 PLT Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9 Hemoglobin Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10 Operational Messages and Data Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11 Parameter Flagging Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15 4. System Specifications Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Data Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Power Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Operational Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Measurement Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Performance Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 4-1 4-2 4-2 4-3 4-3 5. Operating Instructions Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1 Routine Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2 Setup System Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6 Specimen Collection and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7 Sample Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7 Daily Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10 Power Off Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11 Using the Data Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13 6. Calibration Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1 Calibration Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1 Whole Blood Calibration Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3 Pre-Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7 Calibration Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8 Auto-Cal Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9 Factor Entry Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11 Pre-Dilute Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13 Latex Particles Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16 Lyse Volume Dispense Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-18 7. Quality Control Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1 Quality Control Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1 X-B File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1 Table of ContentsC2 CELL-DYN® 1600 Operator's Manual 9140214 Rev ECFebruary 1994 SEARCH BOOK TOC GO BACK Quality Control Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4 Running Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4 Westgard Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6 Commercial Controls QC Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8 Replicate Specimen QC Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9 X-B Analysis QC Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9 Establishing the Target Value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10 Interpreting X-B Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11 CELL-DYN Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11 8. Precautions, Limitations and Hazards Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Location Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Electrical Safety Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Mechanical Safety Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Infection Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Decontamination Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Blood Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Spills . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Reagent Storage and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Printer Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9. Maintenance 8-1 8-1 8-2 8-2 8-2 8-3 8-3 8-3 8-4 8-4 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1 Special Protocols Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2 Preventive Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2 Daily Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3 Daily Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3 Weekly Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4 Open Sampler Auto Clean . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4 Aspiration Probe Exterior Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5 Closed Sampler Auto Clean . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6 Closed Sampler Holder Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7 Monthly Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8 Lyse Inlet Tubing Rinsing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8 Rear Fan Filters Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9 Nonscheduled Maintenance Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-10 Nonscheduled Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-11 Supplemental Aperture Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-11 Aperture Plates Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13 Diluent Syringe Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-16 Sample Syringe Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-19 Sample Aspiration Probe Interior Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . 9-22 HGB Flow Cell Manual Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-24 Vent Line Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-26 CELL-DYN® 1600 Operator's Manual 9140214 Rev ECFebruary 1994 Table of ContentsC3 SEARCH BOOK TOC GO BACK Accumulator Draining and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preparing the Analyzer for a Prolonged Period of Non-Use or for Shipping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Aspiration Probe Removal and Replacement . . . . . . . . . . . . . . . . . . . . . . . . Preventive Maintenance Log for CELL-DYN 1600 . . . . . . . . . . . . . . . . . . . . . . 9-27 9-28 9-29 9-31 10. Troubleshooting Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1 Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1 Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5 11. Printers Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1 12. CELL-DYN 1600CS Closed Sample Aspiration Module Addendum Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1 System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1 Flow Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2 Closed Sample Aspiration Module Installation . . . . . . . . . . . . . . . . . . . . . . . . . 12-3 Tube Guide Adjustment Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-4 Overview of the Run Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5 Verification and Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5 Closed Mode Calibration Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-6 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-6 Closed Mode Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-7 Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-8 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-10 Mode to Mode Verification & Calibration Worksheet . . . . . . . . . . . . . . . . . . . 12-11 Mode to Mode QC Verification Logsheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-13 Appendices Tables Table of ContentsC4 Table T-1: Potential Causes of Erroneous Results with Automated Cell Counters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Table T-2: Normal Values for Automated Blood Counters . . . . . . . . . . . . . . . . Table T-3: Anemia Classification Based on MCV and RDW . . . . . . . . . . . . . . . Table T-4: Progressive Stages of Iron Deficiency . . . . . . . . . . . . . . . . . . . . . . . Table T-5: Morphophysiological Classification of Red Cell Disorders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Table T-6: Result Abnormalities Caused by Artifacts . . . . . . . . . . . . . . . . . . . . T-1 T-2 T-3 T-3 T-4 T-4 CELL-DYN® 1600 Operator's Manual 9140214 Rev ECFebruary 1994 SEARCH BOOK TOC GO BACK Figures Figure 1-1 Front Panel View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Figure 1-2 Flow Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4 Figure 1-3 Lower Left Side Panel Components . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6 Figure 1-4 Rear Panel Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8 Figure 1-5 Upper Right Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8 Figure 2-1 CELL-DYN 1600 Interface Panel (Right Side) . . . . . . . . . . . . . . . . . . 2-3 Figure 2-2 Lower Left Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5 Figure 2-3 Diluent Syringe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7 Figure 2-4 Upper and Lower Front Cover Removal . . . . . . . . . . . . . . . . . . . . . . . 2-8 Figure 2-5 Flow Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9 Figure 6-1 Removing the Front Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-14 Figure 6-2 Vial Closure for Mixing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15 Figure 9-1 Location of Dilution Baths . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13 Figure 9-2 Aperture Plate Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-14 Figure 9-3 Diluent Syringe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-17 Figure 9-4 Sample Syringe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-20 Figure 9-5 Sample Aspiration Probe Assembly . . . . . . . . . . . . . . . . . . . . . . . . . 9-22 Figure 9-6 HGB Flow Cell Manual Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-25 Figure 12-1 Closed Sampler . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2 Figure 12-2 Internal Flow Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2 Figure 12-3 Tube Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-4 Tables Table 2-1 Power Source Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2 Table 2-2 Main Setup Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12 Table 2-3 Acceptable Background and Count Time Data . . . . . . . . . . . . . . . . . . 2-22 Table 4-1 Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 Table 4-2 Dimensions After Packaging for Shipment . . . . . . . . . . . . . . . . . . . . . 4-1 Table 4-3 Power Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2 Table 4-4 Linearity Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4 Table 4-5 Precision at 25EC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5 Table 10-1 Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-7 CELL-DYN® 1600 Operator's Manual 9140214 Rev ECFebruary 1994 Table of ContentsC5 SEARCH BOOK TOC GO BACK Table of ContentsC6 CELL-DYN® 1600 Operator's Manual 9140214 Rev ECFebruary 1994 SEARCH BOOK TOC GO BACK Foreword Congratulations on becoming a proud operator of the CELL-DYN® System. Using state-of-the-art technology, we have designed your instrument to function consistently and dependably on a day-to-day basis. The CELL-DYN System is backed by dedicated professionals who excel in engineering, training and technical expertise. As a valued customer, we will teach you how to operate, maintain and troubleshoot your system. For continuing service, we also provide telephone technical assistance should you need additional information or assistance in diagnosing a problem. This service is available 7 days a week, 24 hours a day. If a problem should arise that cannot be resolved by telephone, on-site support is offered by Abbott's Field Engineers. Our Field Engineers are extensively trained in all aspects of Abbott instrumentation, which assures proficiency in diagnosing, isolating and correcting problems. Abbott Laboratories is dedicated to manufacturing the highest quality, most reliable instrumentation available. We look forward to serving your needs in any way possible. Proprietary Information Entire contents copyright 1994 by Abbott Laboratories. Abbott Laboratories' software programs are protected by copyright. All rights are reserved. This software was developed solely for use with Abbott Laboratories equipment and for in vitro diagnostic applications as specified in the operating instructions. No part of this document may be reproduced, stored or transmitted in any form or by any means (electronic, mechanical, photocopied, recorded or otherwise) without the prior written permission of Abbott Laboratories. The CELL-DYN instrument system is covered by the following U.S. patent: 4,710,021. All operating instructions must be followed. In no event shall Abbott be responsible for failures, errors or other liabilities resulting from customer's noncompliance with the procedures and precautions outlined herein. CELL-DYN® 1600 Operator's Manual 9140214 Rev ECFebruary 1994 i SEARCH BOOK TOC GO BACK Abbott Instrument Warranty For U.S. Customers Only Abbott Laboratories warrants CELL-DYN® Instruments sold by Abbott Sales Representatives (the "Instrument") to be free from defects in workmanship and materials during normal use by the original purchaser. This warranty shall continue for a period of one (1) year, commencing twenty-one (21) days from date of shipment to the original purchaser, or until title is transferred from the original purchaser, whichever occurs first (the "Warranty Period"). If any defects occur during the Warranty Period, contact your Abbott Customer Support Center immediately and be prepared to furnish pertinent details concerning the defect, the Instrument model number and the serial number. Abbott's Warranty coverage limits are as follows: 1. 24 hour-7 day/week phone support from our Customer Support Center. 2. 8:30 a.m.-5:00 p.m. (Monday-Friday, excluding all Abbott-observed holidays) Field Service Engineer support. 3. Any on-site service performed at other times, and all service required to correct defects or malfunctions not covered by this Warranty (as noted in the paragraph below) will be billed at Abbott's labor rates then in effect. This warranty does not cover defects or malfunctions which: ii 1. Are not reported to Abbott during the Warranty Period and within one week of occurrence. 2. Result from chemical decomposition or corrosion. 3. Are caused by customer or third party abuse, misuse or negligence, or by failure to comply with any requirement or instruction contained in the applicable Abbott Operator's Manual. 4. Result from maintenance, repair or modification performed without Abbott's authorization. CELL-DYN® 1600 Operator's Manual 9140214 Rev ECFebruary 1994 SEARCH BOOK TOC GO BACK Abbott's liability for all matters arising from the supply, installation, use, repair and maintenance of the Instrument, whether arising under this Warranty or otherwise, shall be limited solely to the repair or (at Abbott's sole discretion) replacement of the Instrument or of components thereof. In no event shall Abbott be liable for injuries sustained by third parties, incidental or consequential damages or lost profits. Replaced parts shall become the property of Abbott Laboratories. The foregoing is the sole warranty made by Abbott Laboratories regarding the Instrument and Abbott specifically disclaims all other warranties, expressed or implied, including the implied warranties of merchantability and of fitness for a particular purpose. The CELL-DYN® 1600 Series Hematology Systems are manufactured by Abbott Diagnostics, a wholly owned subsidiary of Abbott Laboratories, Abbott Park, IL 60064, U.S.A. Please direct all inquiries concerning information in this manual to the foregoing address. NOTE Direct all inquiries regarding equipment problems to the Abbott Customer Support Center. (U.S. customers only.) CELL-DYN® 1600 Operator's Manual 9140214 Rev ECFebruary 1994 iii SEARCH BOOK TOC GO BACK Abbott Customer Support Center 5440 Patrick Henry Drive Santa Clara, CA 95054 1-800 CELLDYN (235-5396) iv CELL-DYN® 1600 Operator's Manual 9140214 Rev ECFebruary 1994 SEARCH BOOK TOC GO BACK 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 function keypad Times Roman equivalent, Initial Capital letters Status Helvetica equivalent, CAPITAL letters Message Helvetica bold equivalent, CAPITAL letters, enclosed in <> CELL-DYN® 1600 Operator's Manual 9140214 Rev ECFebruary 1994 v SEARCH BOOK TOC GO BACK vi CELL-DYN® 1600 Operator's Manual 9140214 Rev ECFebruary 1994 SEARCH BOOK TOC GO BACK The Revision status of the manual is indicated below. Be sure that the manual contains the latest revision number of all pages. REVISION STATUS Revision Number Pages Revised and Added Originally Issued B 9211352A B 12/88 Not applicable. 9211352B B 4/89 Added Addendum for CELL-DYN 1600CS. 9211352C B 12/92 Added cross-reference Part Number list and name change from Unipath to Abbott Laboratories. 92352-01C B 2/93 Changed Part Number 9211352 to Abbott List Number 92352-01. 92352-01D B 6/93 All pages (Part No. 9140214 Rev D B June 1993). 92352-01E - 12/94 Introduction: updated telephone numbers, patents, trademarks, and parts lists (pp. i, iv, ix, x, xii); Chapter 1: deleted reference to DYN-A-PAK (p. 110); Chapter 3: added description of WBC R4 flag (p. 3-15); Chapter 4: added information regarding material used to verify linearity specifications (p. 43); Chapter 7: modified assay and differential percent verification guidelines (pp. 7-5 and 7-6); Chapter 12 (Closed Sampler Aspiration Module): added instructions for closed mode performance verification with patient samples (p. 12-8). 92352-01F - 4/96 The following pages have changed (Part No. 9140214 Rev F B April 1996): Introduction (p. vii and viii); Chapter 1 (p. 1-9 and 1-10); Chapter 5 (p. 5-7, 5-8, 5-9, and 5-10); Chapter 6 (p. 6-7 and 6-8); Chapter 7 (p. 7-5, 7-6, 7-9, and 7-10); Chapter 8 (p. 8-1 and 8-2); Chapter 9 (p. 9-7, 9-8, 9-9, 9-10, 9-31, and 9-32); Chapter 10 (p. 10-7, 10-8, 10-9, and 10-10); Chapter 12 (p. 12-5, 12-6, 12-9, 12-10, 12-11, and 12-12). ©1993, 1994, and 1996 Abbott Laboratories, Abbott Park, IL 60064. CELL-DYN® 1600 Operator's Manual 9140214 Rev FCApril 1996 vii SEARCH BOOK TOC GO BACK This page has been added in order to maintain a record of persons who review this manual on a periodic basis. Signature viii Date CELL-DYN® 1600 Operator's Manual 9140214 Rev FCApril 1996 SEARCH BOOK TOC GO BACK Reference List of Trademarks The following trademarks are referred to throughout this manual: Teflon is a registered trademark of E. I. duPont de Nemours. Vacutainer is a registered trademark of Becton Dickinson and Company. CELL-DYN® 1600 Operator's Manual 9140214 Rev ECFebruary 1994 ix SEARCH BOOK TOC GO BACK 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 Abbott List No. Description Configuration 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 Controls & Calibrators x CELL-DYN® 1600 Operator's Manual 9140214 Rev ECFebruary 1994 SEARCH BOOK TOC GO BACK CELL-DYN Consumables Abbott List No. Description 99644-01 CELL-DYN® Enzymatic Cleaner 2 X 50 mL 93641-01 CELL-DYN® Enzymatic Cleaner 1 x 50 mL 99610-01 CELL-DYN® Micro-Pipettes, 40 FL 100/pkg. 99620-01 CELL-DYN® Printout Tickets - TP250 1000/pkg. 30005-01 Graphic Printer Paper, (8-1/2 x 11) 2600/pkg. 91282-01 Eaton TP250 Ticket Printer Ribbon 1 93400-01 Epson FX85 Graphic Printer Ribbon 1 13401-01 Okidata 320 Graphics Ribbon 1 93410-01 Fujitsu DX2100 Graphics Ribbon 1 13411-01 Citizen MSP-40 Graphics Ribbon 1 13412-01 Citizen 120-D Graphics Ribbon 1 99660-01 DYN-A-WIPES Lint-Free Wipes 125/pkg. 98661-01 DYN-A-WIPES Lint-Free Wipes 40 boxes/case 99605-01 CELL-DYN® Sample Vials 500/pkg. 99606-01 CELL-DYN® Sample Vials 3000/pkg. CELL-DYN® 1600 Operator's Manual 9140214 Rev ECFebruary 1994 Configuration xi SEARCH BOOK TOC GO BACK CELL-DYN Parts & Accessories Abbott List No. Description Configuration 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 1800-933-5535. To place an order for products that have a List Number, contact the Customer Service Center in Chicago at 1-800-323-9100. If you require technical assistance on your CELL-DYN instrument, contact the Customer Support Center at 1-800-CELLDYN. xii CELL-DYN® 1600 Operator's Manual 9140214 Rev ECFebruary 1994 SEARCH BOOK TOC GO BACK Chapter 1 System Description System Description Introduction The CELL-DYN® 1600 is a multi-parameter hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The instrument has two versions, the CELL-DYN 1600, which accepts specimens from open collection tubes only, and the CELL-DYN 1600CS, which accepts specimens in either open or closed collection tubes. The CELL-DYN 1600CS is equipped with an attached closed sample aspiration module referred to as the closed sampler. The closed sampler aspirates blood from a closed collection tube that has been inserted in the sampler module. Operating and maintenance instructions for the CELL-DYN 1600CS are described in the Addendum for the CELL-DYN 1600CS operation. Intended Use The CELL-DYN 1600 generates the following measurements on EDTA anticoagulated whole blood: WBC — White Blood Cell or leukocyte count RBC — Red Blood Cell or erythrocyte count HGB — Hemoglobin concentration PLT — Platelet or thrombocyte count LYM — Lymphocyte absolute count %LYM — Lymphocyte percent GRAN — Granulocyte abslolute count %GRAN — Granulocyte percent MID — Mid-range absolute count %MID — Mid-range percent MCV — Mean Cell Volume HCT — Hematocrit MCH — Mean Cell Hemoglobin MCHC — Mean Cell Hemoglobin Concentration RDW — Red Cell Distribution Width MPV — Mean Platelet Volume PCT* — Plateletcrit PDW* — Platelet Distribution Width * Clinical significance has not been established for these parameters. Therefore, they are not reportable. System Components The CELL-DYN 1600 is a single unit that includes a specimen analyzer and a data module. CELL-DYN® 1600 Operator's Manual 9140214 Rev E — February 1994 1-1 SEARCH BOOK TOC GO BACK System Description Chapter 1 Specimen Analyzer The Specimen Analyzer section contains the hardware to aspirate, dilute, and analyze each whole blood specimen. Data Module The Data Module section includes the computer, video display monitor, membrane keypad, disk drive, and printer. The disk drive is described in the Right Panel section of this chapter. The printers are described in Chapter 11, Printers. Specimen Analyzer Components Front Panel The components visible on the front of the analyzer are identified in Figure 1-1. The functional description of each component follows. Figure 1-1 Front Panel View Upper Front Cover The Upper Front Cover protects the upper flow panel. A green grounding wire provides electrical continuity for shielding purposes. Access to the upper flow panel is necessary to completely view the operation of the upper flow panel components and to perform certain maintenance operations. Lower Front Cover The Lower Front Cover protects the lower section of the flow panel. Access to the lower flow panel is necessary to view the action of the lower flow panel components and to perform certain maintenance procedures. 1-2 CELL-DYN® 1600 Operator's Manual 9140214 Rev E — February 1994 SEARCH BOOK TOC GO BACK Chapter 1 System Description Sample Aspiration Probe The Sample Aspiration Probe is used to aspirate whole blood from an opened collection tube or from a sampling cup in the CELL-DYN 1600CS. After each aspiration, waste liquid on the outside of the probe is removed as the probe is drawn through the wash block. Touch Plate The Touch Plate is a spring plate located directly behind the sample aspiration probe. Pressing the touch plate starts the selected run cycle. Data Module The Data Module contains the video display monitor, central processing unit, and membrane keypad. CELL-DYN 1600 operations are controlled by high-speed microprocessors that monitor system status, perform the various analytical routines used by the instrument, perform diagnostic checks, and store result data. Serial data (ASCII format) may be transferred to an external computer through an RS232 connector on the back panel. Data transmission may be done either automatically as samples are processed or by command of the operator. Parallel data may be output to an on-line printer. Data Storage Results are stored on the disk drive for the most recent 320 cycles. No graphic data are stored. The 3.5" disk drive is located below the membrane keypad of the CELLDYN 1600. Video Display Screen A 14-inch diagonal monochrome Video Display Screen displays all alphanumeric and graphic data. Membrane Keypads A row of eight unlabeled pressure-sensitive keys is located directly below the screen. Each key generates an audible tone when pressed and initiates a function defined by the screen label currently displayed directly above it. A numeric and special function keypad is located directly below the row of eight unlabeled keys. Each key generates an audible tone when pressed. This membrane keypad contains the following numeric and special function keys: CELL-DYN® 1600 Operator's Manual 9140214 Rev E — February 1994 Numeric Keys — a block of ten numeric keys, labeled from 0 to 9, and a decimal key which are used to enter numeric data 1-3 SEARCH BOOK TOC GO BACK System Description Chapter 1 Flow Panel ENTER Key — stores entered numeric data and advances the cursor to the next entry location Asterisk (*) Key — allows the operator to escape (abort) data entry before it is completed Arrow Keys — a set of four keys used to move the cursor in the direction depicted by each arrow Pound (#) Key — used for service functions only The major components of the Flow Panel are depicted in Figure 1-2. The functional description of each component follows. Figure 1-2 Flow Panel Wash Block The Wash Block rinses the outside of the sample aspiration probe with Diluent. Excess Diluent is routed to the waste container. RBC/PLT Metering Assembly The RBC/PLT Metering Assembly contains a precision-bore glass tube with a set of optical detectors, one upper and one lower, mounted on it. It is used to meter a fixed volume of the RBC/PLT dilution during the RBC/PLT measurement portion of each cycle. RBC/PLT Transducer Assembly The RBC/PLT Transducer Assembly contains the fluidics and hardware required for accurate measurement of the diluted red blood cells and platelets. The primary components of this assembly are: 1-4 CELL-DYN® 1600 Operator's Manual 9140214 Rev E — February 1994 SEARCH BOOK TOC GO BACK Chapter 1 System Description The RBC/PLT Transducer — The transducer contains two chambers. The mixing chamber on the left is used to mix the RBC/PLT dilution. The counting chamber on the right contains the von Behrens plate used to prevent cells that have traversed the aperture from recirculating into the sensing zone. Electrodes — There are two non-corrosive, electrically conductive plates, one positively charged and one negatively charged. One electrode is located in each transducer chamber. The electrodes conduct a constant current flow through the aperture during the RBC/PLT measurement portion of each cycle. RBC/PLT Aperture Plate — This plate is inserted into a slot between the two transducer chambers. A jewel containing the aperture is heat embedded into the plate. WBC Metering Assembly The WBC Metering Assembly contains a precision-bore glass tube with a set of optical detectors, one upper and one lower, mounted on it. It is used to meter a fixed volume of WBC/HGB dilution during the WBC measurement portion of each cycle. WBC Transducer Assembly The WBC Transducer Assembly contains the fluidics and hardware required for accurate measurement of the diluted white blood cells. The primary components of this assembly are: CELL-DYN® 1600 Operator's Manual 9140214 Rev E — February 1994 WBC Transducer — The transducer contains two chambers. The mixing chamber on the left is used to mix the WBC/HGB dilution. The counting chamber on the right contains the von Behrens plate used to prevent cells that have traversed the aperture from recirculating into the sensing zone. Electrodes — There are two non-corrosive, electrically conductive plates, one positively charged and one negatively charged. One electrode is located in each transducer chamber. The electrodes conduct a constant current flow through the aperture during the WBC measurement portion of each cycle. WBC Aperture Plate — This plate is inserted into a slot between the two transducer chambers. A jewel containing the aperture is heat embedded into the plate. 1-5 SEARCH BOOK TOC GO BACK System Description Chapter 1 HGB Flow Cell Assembly The HGB Flow Cell Assembly contains the following components: A fully enclosed (light-tight), flow-through glass cuvette An LED light source An interference filter used to obtain the ICSH recommended wavelength of 540 nm A photodetector for measuring the light transmitted Lower Left Side Panel The components on the Lower Left Side Panel of the analyzer are depicted in Figure 1-3. The functional description of each component follows. Figure 1-3 Lower Left Side Panel Components Waste Sensor Connector The waste-full sensor plug connects to the Waste Sensor Connector port. When the electrical sensor is tripped, the <WASTE FULL> message is generated and the READY status is inhibited until the situation is corrected. The analyzer interprets a disconnected plug the same way as a full waste container. Therefore, if the waste is routed to a drain, a dummy plug must be inserted in the connector. Detergent Inlet Tube Connector This color-coded (green) port is used to connect the Detergent inlet tube with its associated cap, weighted end and label. 1-6 CELL-DYN® 1600 Operator's Manual 9140214 Rev E — February 1994 SEARCH BOOK TOC GO BACK Chapter 1 System Description Diluent Inlet Tube Connector This color-coded (red) port is used to connect the Diluent inlet tube with its associated cap, weighted end and label. HGB Lyse Inlet Tube Connector This color-coded (blue) port is used to connect the WBC/HGB Lyse inlet tube with its associated cap, weighted end and label. Waste Outlet Tube Connector This color-coded (black) port is used to connect the waste outlet tube. Normally Closed Valves The two Normally Closed Valves prevent the detergent and diluent from draining down into the analyzer when the analyzer power is turned OFF. Lyse Pump Assembly The Lyse Pump Assembly consists of a rotor, tubing and pump tube holder. It controls the volume of lyse reagent dispensed during each cycle. It also prevents the drainage of lyse from the flow system when the power is OFF. Syringe Assembly The Syringe Assembly contains two syringes. Diluent Syringe - delivers a specific volume of Diluent to transport the blood to the mixing chambers. Sample Syringe - aspirates a specific volume of sample. CELL-DYN® 1600 Operator's Manual 9140214 Rev E — February 1994 1-7 SEARCH BOOK TOC GO BACK System Description Rear Panel Chapter 1 The components visible on the Rear Panel of the analyzer are depicted in Figure 1-4. The functional description of each component follows. Figure 1-4 Rear Panel Components Fans Air intake fans cool the internal components of the analyzer. They are covered with filters that are easily removed, as required, for routine cleaning. Analyzer Power Connector This receptacle is used to connect the main power cord to the analyzer. Upper Right Side Panel The components visible on the Upper Right Side Panel of the analyzer are depicted in Figure 1-5. The functional description of each component follows. Figure 1-5 Upper Right Side Panel 1-8 CELL-DYN® 1600 Operator's Manual 9140214 Rev E — February 1994 SEARCH BOOK TOC GO BACK Chapter 1 System Description Analyzer Power Switch This is the main power switch for the analyzer. Reset Button This push button restarts the computer in the CELL-DYN 1600. Brightness Control This control adjusts the brightness of the video display screen. Serial Interface Connector This port is used to connect a serial connector to an optional external device that accepts serial data in ASCII format. Parallel Interface Connector This port is used to connect the 25-pin printer cable from the graphics printer supplied with the analyzer. Ticket Printer Connector This port is used to connect the 25-pin printer cable when the printer is used to print data in a ticket format. Reagent System Introduction The Reagent System is formulated specifically for the CELL-DYN 1600 series instrument flow systems in order to provide optimal system performance. Use of reagents other than those specified in this manual is not recommended as instrument performance can be affected. Each CELL-DYN 1600 series system is tested at the factory using the specified reagents, and all performance claims are generated using these reagents. Reagents must be stored at room temperature to ensure optimal performance. All reagents should be protected from direct sunlight, extreme heat and freezing during storage. Temperatures below 32oF (0oC) may cause reagent layering that changes the tonicity and conductivity of the reagents. If any reagent has been frozen, it should not be used. CAUTION CELL-DYN® 1600 Operator's Manual 9140214 Rev F — April 1996 When a reagent is changed, a normal background should be run to ensure that the system is primed immediately prior to running any specimens. 1-9 1-9 SEARCH BOOK TOC GO BACK System Description Chapter 1 The reagent inlet tubes have a cap attached that minimizes evaporation and contamination during use. However, reagent quality may deteriorate with time. Therefore, use all reagents within the dating period indicated on the label. Diluent CELL-DYN Diluent is formulated to meet the following requirements: • • • • Lytic Agent CELL-DYN Lytic Agent is formulated to meet the following requirements: • • • Detergent 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 Rapidly lyse the red blood cells and minimize the resultant stroma Alter the white cell membrane to allow the cytoplasm to slowly diffuse and to allow the membrane to shrink around the nucleus and any granules that may be present Convert hemoglobin to a modified hemiglobincyanide complex that is measurable at 540 nm (The quaternary ammonium lysate participates as a chromagen) CELL-DYN Detergent is formulated to meet the following requirements: • • • Provide an optically clear solution that is needed to obtain the zero reference during the Hemoglobin measurement cycle Provide proper meniscus formation in both metering tubes and maintain it during each run cycle Rinse both counting chambers, both metering tubes and the HGB flow cell with minimal bubble formation Enzymatic Cleaner CELL-DYN Enzymatic Cleaner is formulated to effectively remove protein build-up within the instrument. 1-10 1-10 CELL-DYN® 1600 Operator's Manual 9140214 Rev F — April 1996 SEARCH BOOK TOC GO BACK Installation Introduction Installation of the CELL-DYN® 1600 should be performed by an Abbott authorized representative to ensure that all system components are functioning correctly and to verify system performance. Installation procedures must be repeated if the analyzer is moved from the original installation site. NOTE Installation of the analyzer by an unauthorized or untrained person could result in damage to the system and may void the warranty. Never attempt to install the system without an Abbott authorized representative present. The remainder of this chapter gives general requirements for a successful installation. The installation procedures for the Closed Sampler are contained in the CELL-DYN 1600CS Addendum. Initial Preparation Inventory The instrument is shipped from the factory as follows: Space Requirements Analyzer Accessories and the Accessory Kit Graphics Printer Ticket Printer (optional) Reagents, Calibrator, and Controls necessary for installation. Approximately four (4) linear feet of space is required on the countertop. Allow sufficient space on the countertop, or below the instrument, for Diluent, Lyse, and Detergent. Provide space below the instrument for the waste container (if one is used). Allow two (2) to four (4) inches of space behind and on the left side of the analyzer for air flow. A constant circulating internal air stream is required to cool circuitry and components whenever the power is. If possible, allow 24 inches of space above and to either side of the instrument for service access. Locate the instrument: Away from direct sunlight. Away from the path of a cooled or heated air outlet. Far from a centrifuge, X-ray equipment, CRT, video terminal, computer or copier. Place the reagents on the same level or below the instrument. CELL-DYN® 1600 Operator's Manual 9140214 Rev D— June 1993 2-1 SEARCH BOOK TOC GO BACK Waste Requirements Allow room for a suitable waste container below the unit, or position the instrument to permit the waste to be routed directly to a drain. The drain must be suitable for disposal of waste with possible biological and chemical hazard. Be sure that the waste outlet tube is secured in the drain hole. (Refer to Tube Installation for installation instructions.) Power Requirements Be sure that the system is located at the desired site before attempting any connections. A grounded power outlet is required. A voltage regulator may be necessary for optimum performance. Insert the power cord into the power cord connector on the rear panel. Do not turn the power ATTENTION Check all side and rear panel connectors for particles or foreign material that can impair electrical contact when connections are made. ! "" #""$ %"&' "" #""$ ("&' % "% %$ ("&' % #% )%$ %"&' )" " %"$ %"&' The CELL-DYN 1600 is designed for low power consumption. The instrument automatically performs an initialization cycle whenever power is turned During the daily routine operating period, power should be left . 2-2 CELL-DYN® 1600 Operator's Manual 9140214 Rev D— June 1993 SEARCH BOOK TOC GO BACK Printer Installation Overview Remove the printer(s) from the shipping container and visually inspect for damage. Find a suitable location adjacent to the analyzer. Be sure that the printer power switch is in the ** position. The printer manuals should be stored in a convenient location. NOTE If the printer(s) is placed on top of the instrument, be sure that the paper does not restrict air flow to the rear analyzer fans. When used with the CELL-DYN 1600, the graphics printer prints graphic reports and the ticket printer prints individual preprinted tickets. Depending on the output desired, one or both printers may be connected to the analyzer. CELL-DYN 1600 Interface Panel (Right Side) Follow installation instructions carefully to be sure that the printer(s) is connected to the correct port on the analyzer. For convenience, general instructions are provided for loading individual pre-printed tickets in the ticket printer. For a detailed description of the printer components and operating instructions, refer to the manuals that accompany the printer(s). Graphics Printer CELL-DYN® 1600 Operator's Manual 9140214 Rev D— June 1993 1. Assemble the printer as directed in the printer manual. 2. Make sure that the printer power switch is **. Plug the power cord into the printer. Do not plug the other end into a grounded outlet until you are ready to power . 3. Locate the ribbon cable in the accessory kit and attach it to the connector labeled +, (See Figure 2-1.) Attach the cable's other end to the printer's rear panel connector. Refer to the printer's operation manual for detailed installation procedures. 2-3 SEARCH BOOK TOC GO BACK Self-Test Printouts NOTE Ticket Printer 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 . Run self-test printouts before using the printer for the first time. These self-tests may be run any time to verify proper printer operation. The CELL-DYN 1600 software automatically controls and adjusts most print conditions for the graphics printer, including page width. Occasionally, a few settings may need to be changed in the printer's software for correct operation. If printing is not what you expect, refer to the printer manual for guidance in making adjustments. If you have additional questions or experience any problems, call the Abbott Customer Support Center for assistance. The ticket printer is used to print result data on 3.25-inch wide, multiple copy, carbon or carbonless tickets. Each ticket is automatically fed into the printhead, clamped, printed, and fed out of the printhead. A form sensor ensures that each ticket is properly positioned prior to clamping. 1. Assemble the printer as directed in the printer manual. 2. Make sure that the printer power switch is **. Plug the power cord into the printer. Do not plug the other end into a grounded outlet until you are ready to print. 3. Attach the cable for the ticket printer to the connector labeled + -. +. which is just below the $$.+.*$ . on the analyzer. (See Figure 2-1.) Attach the cable's other end to the printer's rear panel connector. Refer to the printer manual for detailed installation procedures. 4. Install the ribbon cartridge as directed in the printer manual. ATTENTION An improperly installed ribbon cartridge can cause the ribbon to jam in the printhead drive mechanism. Self-Test Printouts 2-4 Plug the power cord into a grounded outlet and turn the toggle switch . Insert a ticket into the guide. A self-test mode checks operation and prints self-test data at the completion of the check. CELL-DYN® 1600 Operator's Manual 9140214 Rev D— June 1993 SEARCH BOOK TOC GO BACK Tube and Diluent Syringe Installation Reagent and Waste Tubes 1. Locate the reagent inlet tubes in the accessory kit. 2. Inspect each tube carefully for damage or cracks. Lower Left Side Panel CELL-DYN® 1600 Operator's Manual 9140214 Rev D— June 1993 3. Attach the non-weighted end of the tube with the Red Diluent label to the Red side panel connector. Wipe the outside of the tube with a damp lint-free tissue and place the weighted end into the container of CELL-DYN Diff-Screen Diluent. Secure the cap. Place the container on the same level or lower than the unit. 4. Attach the non-weighted end of the tube with the Green Detergent label to the Green side panel connector. Wipe the outside of the tube with a damp lint-free tissue and place the weighted end into the container of CELL-DYN Diff-Screen Detergent. Secure the cap. Place the container on the same level or lower than the unit. 5. Attach the non-weighted end of tube with the Blue Lyse label to the Blue side panel connector. Wipe the outside of the tube with a damp lint-free tissue and place the weighted end into the container of CELL-DYN Diff-Screen Lyse. Secure the cap. Place the container on the same level or lower than unit. 2-5 SEARCH BOOK TOC GO BACK 6. Attach the Waste Outlet Tube to the Black side panel connector. Place end of the tube with the cap and sensor into the waste collection container. Secure the cap. Or, remove the cap from the tube and place the tube into a drain suitable for collection of waste with possible biological and chemical hazard. Be sure that the tube is secured to the drain hole. Locate the Waste Full Sensor plug attached to the cap's electrode wires. Insert the plug into the /$. connector located on the left panel. When the waste tube is placed directly into a drain, insert a "dummy" plug into the /$. connector. If a "dummy" plug is not inserted, the /$.*0 alert is activated. Normally Closed Valves The tubes for the normally closed valves on the left panel were removed from the valves for shipment. 1. Locate the lower normally closed valve (black octagon), just above the Lyse Pump Assembly, and the diluent inlet tube. Carefully stretch the tube between your hands and insert it into the valve opening. Work the tube gently back and forth until it is completely inserted into the valve. 2. Locate the upper normally closed valve (black octagon) above the diluent valve and the detergent inlet tube. Carefully stretch the tube between your hands and insert it into the valve opening. Work the tube gently back and forth until it is completely inserted into the valve. Lyse Tube Installation in Pump 2-6 1. Locate the inlet/outlet tube connection panel, lyse pump rotor and lyse tube. Locate the lyse pump tube holder directly below the pump rotor and tube stops on both sides of rotor. The tube stops prevent the lyse tube from moving during lyse pump rotor action. 2. Press down on the tube holder at portion closest to the front panel. (Refer to Figure 2-2.) Hold the tube holder down and insert the lyse tube under the rotor and into the tube stops — confirm that tube is not crimped or pinched. Release the tube holder. CELL-DYN® 1600 Operator's Manual 9140214 Rev D— June 1993 SEARCH BOOK TOC GO BACK Diluent Syringe Installation Before shipment, the diluent syringe is removed, cleaned and reinstalled in the dispenser. It is not attached at the luer lock fitting of the 3-way directional valve. A protective cap is attached to the luer lock fitting. CELL-DYN® 1600 Operator's Manual 9140214 Rev D— June 1993 1. Slide the plastic cover on the left side panel towards the rear to gain access to the diluent syringe. 2. Remove the thumb nuts on the syringe holder block and remove the front section of the holder block. Save the thumb nuts and the block. 3. Locate and unscrew the protective cap attached to the luer lock fitting for shipment. 4. Extend the barrel of the Diluent Syringe syringe until it touches the luer lock fitting. Secure the syringe onto the luer lock fitting by turning it counterclockwise (as viewed from above) until it is finger tight — do not overtighten. 5. Replace the front section of the syringe holder block and secure it with the two (2) thumb nuts removed in step 2 above. Tighten the thumb nuts finger tight only. 2-7 SEARCH BOOK TOC GO BACK Flow Panel Inspection and Installation Upper Front Cover Removal The upper front cover must be removed to gain access to the flow panel normally closed valve. The diluent tube, normally inserted in this valve, was removed for shipment. To ensure correct system operation, this tube must be completely inserted before the power is turned on. Upper and Lower Front Cover Removal NOTE 2-8 1. Locate, on the lower edge of the upper front cover, the screw used to securely attach the cover during shipment. Remove the screw and save it. The screw must be reinstalled to move or ship the instrument. 2. Grasp the lower portion of upper front cover and pull it out - towards you about 1 inch; then pull it up until it releases from the upper mount brackets. 3. To remove the cover completely, detach the ground wire at the connector attached to analyzer's main frame. Remove the cover. Performance may be affected if the ground wire is not reconnected before cover is reinstalled. CELL-DYN® 1600 Operator's Manual 9140214 Rev D— June 1993 SEARCH BOOK TOC GO BACK Lower Cover Removal 1. Locate the thumb screw on upper left side of lower front cover; turn it counterclockwise 2 to 3 turns to loosen it. Slide the cover to your left about 1 inch until the right side is free of the screen bezel cover and remove the thumb screw. 2. Raise the cover about 1 inch to release the bottom edge from the lower mount brackets. 3. Pull cover out and set it aside. Flow Panel Inspection ATTENTION The diluent tube MUST be installed before the power is turned for the analyzer to operate correctly. CELL-DYN® 1600 Operator's Manual 9140214 Rev D— June 1993 1. Locate, on the upper left portion of the flow panel, the normally closed (black octagon) valve, and the removed diluent tube. See Figure 2-5. 2. Carefully insert the diluent tube into the valve opening. Work the tube gently back and forth until it is completely inserted into the valve. Unless this tube is securely seated, the message !" may be displayed and the flow system will not function properly. 3. Confirm the tube connections and fittings on BOTH ends of the tube. 4. Inspect the flow panel components: each dilution bath and aperture plate, all tubes, connectors, valves, etc. for damage. 2-9 SEARCH BOOK TOC GO BACK Data Diskette Installation Power On 1. Locate the two 3.5" diskettes taped to the inside of the left side panel compartment. 2. Remove the protective cardboard in the floppy disk drive. Save the cardboard insert and spare diskette. 3. Position the diskette so that the metal edge is inserted first and the diskette label is up and readable. Insert the diskette into the drive on the side of the instrument The CELL-DYN 1600 is designed for low power consumption. Whenever the power is applied, an initialization cycle is performed to check system status, to place mechanical components in the "home" position, and when acceptable, to place the unit in an initialized state. Power On and Initialization 1. Confirm that the power plugs for the analyzer and the printer(s) are inserted into the line voltage regulator or a grounded power outlet. 2. Move the printer's power switch to . Confirm that the graphic printer paper is installed and feeding correctly. 3. Move the analyzer's power switch to . The screen illuminates within 15 to 30 seconds and the statement # # $ %" appears in the upper center screen System Status box. When the cycle is complete, the message +++$+1.2 displays in the Status Box. At initial installation, before activating an Auto-Startup cycle, allow the analyzer to warm up for 5 minutes. System setup can be performed at this time. NOTE An Auto-Startup cycle actuates whenever the &'(key is pressed and +++$+1.2 or $234 appears in the System Status box. Each Auto-Startup cycle primes the flow system with reagents and checks the background. Operator ID Number Entry A two-digit identification number for the current operator is entered only when the 5$+5.0 is displayed. At the completion of each Power On Initialization cycle, the 5$+5.0 is displayed with the cursor flashing at the 6.$+2> field. 2-10 CELL-DYN® 1600 Operator's Manual 9140214 Rev D— June 1993 SEARCH BOOK TOC GO BACK Enter the two digit identification number using the numeric keys on the keypad below the screen. The Operator ID can be entered ONLY when the 5$+5.0 is displayed. NOTE An Operator ID is not required for system operation. The Sequence Number The Sequence Number display below the 6.$+27 field automatically increments by one each time a Run cycle is actuated by pressing the touch plate. The sequence number cannot be entered or changed by the operator. Setup System Operation The .05.0 is used to review and change options for data format to output devices such as printers and computers. The units of measure display and print format options are also selected from this screen. ** The function is active. The function is not active. Any number displayed in place of or ** can be changed using the numeric keys on the keypad to enter a new number within the stated limits. For example, the number preceding the "line-feeds per printer page" statement applies to the graphic printer and indicates the current line-feed selection. CELL-DYN® 1600 Operator's Manual 9140214 Rev D— June 1993 2-11 SEARCH BOOK TOC GO BACK Installation Chapter 2 Main SETUP MENU Screen The numbers on the main SETUP MENU screen shown below correspond to the following numbered options: Table 2-2 Main SETUP MENU Screen ================================================= 1 ON X-B Moving-Average Program 2 OFF Automatic Increment of Specimen I.D. Number 3 ON Print Histograms 4 OFF Print MPV, PCT, PDW 5 OFF Print ALERTED LYM/%L, *MID/%M, GRAN/%G Results 6 OFF Print ALERTED PLT Results 7 OFF Automatic Ticket Printout 8 ON Automatic Graphics Printout 9 66 Line-Feeds per Form-Feed on Graphics Printer (01 TO 99) 10 OFF Automatic Transmission to Computer 11 OFF Automatic Transmission of Histograms 12 0.3 Transmission Time-Out (0.1 TO 9.9 Seconds) 13 1 Units of Measure: 1 = Factory (United States) 2 = SI Units 3 = SI Units (HGB/MCHC in MMOL/L; MCH in FMOL) 4 = SI Units (HCT/PCT in %) 1. NOTE 2-12 ================================================= X-B Moving Average Program — When this option is enabled, the X-B Moving Average Program is activated. 2. Automatic Increment of Specimen ID Number — When this option is enabled, the specimen ID number entered will automatically increment by one for the next sample, unless a new ID number is entered. 3. Print Histograms — When this option is enabled, the WBC, RBC, and PLT histograms are printed with each specimen report. 4. Print MPV, PCT, PDW — When this option is enabled, the MPV, PCT, and PDW results are printed with each specimen report. Clinical significance has not been established for PCT and PDW; therefore, they are not reportable. CELL-DYN® 1600 Operator's Manual 9140214 Rev DC June 1993 SEARCH BOOK TOC GO BACK CELL-DYN® 1600 Operator's Manual 9140214 Rev D— June 1993 5. Print ALERTED LYM/%L, *MID/%M, GRAN/%G Results — When this option is enabled, the results for these flagged parameters are printed on the specimen report. 6. Print ALERTED PLT Results — When this option is enabled, the results for a flagged PLT are printed on the specimen report. 7. Automatic Ticket Printout — When this option is enabled, a specimen report is automatically printed on the ticket printer. 8. Automatic Graphic Printout — When this option is enabled, a specimen report is automatically printed on the graphics printer. 9. Line-Feeds per Form-Feed on Graphics Printer (01 to 99) — When the entered number is 66, one report is printed per 8.5" by 11" sheet of paper. To print two reports per sheet of paper, enter 33 and align the paper in the printer so that the top edge is even with the ribbon. 10. Automatic Transmission to Computer — When this option is enabled, the specimen report is automatically transmitted to a host computer. 11. Automatic Transmission of Histograms — When this option is enabled, the WBC, RBC, and PLT histograms are automatically transmitted to a host computer. 12. Transmission Time-Out (0.1 to 9.9 Seconds) — This option sets the amount of time (in seconds) the analyzer will attempt to send a report. If the transmission fails, the analyzer will “time-out.” 13. Units of Measure — This option sets the appropriate units of measure for the results on the specimen report. 2-13 SEARCH BOOK TOC GO BACK To Review or Change Setup Status 1. At the 5$+5.0, press &) (. The .05.08!. Review and/or change any selection on the .05.0 screen. 2. ARE THE SELECTIONS ACCEPTABLE? YES Go to the Date/Time Setup procedure. NO Use the #* keys on the keypad to move the cursor to the selection requiring change. Press to toggle between or** OR Type the new number that is within the limits shown for the selection. Repeat this process until all required changes are complete. Go to the Date/Time Setup procedure. Keypad Setups Date/Time Key Date and time are maintained by an internal battery-powered clock. The current date and time display in the upper right of the screen. The multiple date format option allows the operator to select the desired date format. Date re-entry is not required when a new format option is selected and the current date is correct. The hour clock cannot differentiate between AM and PM. To avoid confusion, use a 24-hour clock. (For example, 1 for 1 AM and 24 for 12 midnight.) Change the Date and Time 1. From the .05.0, press &#+ (. The .02$.9+5.5.0 displays. 2. IS THE DISPLAYED DATE FORMAT CORRECT? YES Go to step 3. NO 2-14 Type the number for the desired date format option. Go to step 3. CELL-DYN® 1600 Operator's Manual 9140214 Rev D— June 1993 SEARCH BOOK TOC GO BACK 3. IS THE DISPLAYED DATE AND/OR TIME CORRECT? YES Press &''( to return to the.05.0. The date entry is not required when the date is correct and only the format requires change. NO Enter the date (using MM/DD/YY) and/or the time (using a 24-hour clock). Repeat the process until all required changes are complete. NOTE A slash and/or colon must be entered when setting the date or time. 4. Press &''( to return to the .05.0. Patient Range Entry Key Upper and lower alert limits for patient specimen results can be entered, reviewed, and changed as required via the & #'#%'!( key. Entered values are used to flag patient specimen results for each of the 18 parameters. When a parameter result exceeds an entered limit, each affected result displays in inverse video (backlit) and prints underlined on the graphic printer with an "*" preceding on the ticket printer. Entered limits print at the top of each displayed or printed Data Log summary page. To Change Patient Range Entries 1. At the .05.0 press & #'#%'!(. The $+.$:..4 screen displays. 2. ARE THE LIMITS ACCEPTABLE? YES Press &''( to return to the.05.0. NO Use the #* keys to move the cursor to the numbers that are to be changed, and type the new limits. Repeat this process until all the limits are acceptable. The cursor advances automatically to the next field if the value entered contains the maximum number of digits for the field. If the number contains less than the maximum number of digits, press to move the cursor to the next field. Press &''( to return to the .05.0. CELL-DYN® 1600 Operator's Manual 9140214 Rev D— June 1993 2-15 SEARCH BOOK TOC GO BACK Reagents Log Key &'#%),%( displays a new screen and labels allowing the operator to select a specific reagent type: diluent, detergent, or lyse. Additional screens and labels allow the operator to enter, review or print: container size, lot number, expiration date, and open date for up to ten containers per reagent. To Complete the Reagents Log 1. At the .05.0, press &'#%),%(. The .. .$:. screen displays. 2. Select a Reagent Log by pressing the appropriate keypad: & (, &!)(, or &'%( The selected log screen displays with the cursor positioned on the first blank line of the log. 3. Enter the Size, Lot#, Expiration Date, and Open Date. This screen only accepts numbers in the fields on the screen. Repeat this process until all entries for the reagent log are complete. If the value entered into a field contains less than the maximum number of digits allowed for the field, press . The cursor moves to the next field. 4. Press & ' ( to print the log. 5. Press &''(. Repeat steps 2-4 for each reagent type. OR To return to the .05.0, press &''(, and then &) (. Control File Setup Key The Control File Setup function allows the operator to select a specific control file to enter, review, change, or print numeric data pertaining to selected file(s), e.g., lot number, expiration date, printed insert mean and limits, etc. Any run result exceeding these entered limits is displayed in inverse video and underlined on the graphic printout. The information is printed with an "*" on the ticket printer. 2-16 CELL-DYN® 1600 Operator's Manual 9140214 Rev D— June 1993 SEARCH BOOK TOC GO BACK To Select a Specific Control File 1. At the .05.0, press & ) ( The message '))),-!" displays in the Status Box. 2. Press the corresponding key for the type of control to be updated: &,.,',(, &,'#,',(, or &/ %/,',(. The *+..0 screen displays. 3. IS THE LOT NUMBER ENTRY ACCEPTABLE? YES Press . Go to step 4. NO Enter the lot number (up to nine digits) and press . The data is stored and the cursor advances to the next field. This field accepts only numeric data. If the lot number is less than nine digits, press to advance the cursor. 4. IS THE EXPIRATION DATE ENTRY ACCEPTABLE? YES Press 0 Go to step 5. NO 5. Type the expiration date (using MM/DD/YY) from the control vial or assay sheet. IS THE WESTGARD RULE SELECTION ACCEPTABLE? YES Go to step 6. NO Set the cursor at the rule requiring change, and press . Repeat this process until all rule selections are acceptable. Go to step 6. 6. REVIEW RANGE OR MEAN/LIMITS? YES Press &'#%( or &#+ )(. The screen for the selected control file displays. Go to step 7. NO CELL-DYN® 1600 Operator's Manual 9140214 Rev D— June 1993 Press &''( to return to *+..05.0. 2-17 SEARCH BOOK TOC GO BACK 7. ARE THE VALUES ACCEPTABLE? YES Go to step 8. NO Use the #* keys to move the cursor to the first value to be changed and type the new value. If the value has less than three digits, press the key to store the data and advance the cursor. Repeat this process until all values are entered and acceptable. Go to step 8. 8. IS A PRINTOUT REQUIRED? YES Press & ' (. NO Go to step 9. 9. IS ANOTHER CONTROL SETUP REQUIRED? YES Press &''( twice to return to the *+..05.0. Repeat steps 2-9 for each control as required. NO Press &''( twice. Press &) ( to return to .05.0 screen. Replicate File Setup Key Nine QC files, labeled 1 to 9, are designated for use with replicate "control" specimens, such as: retained patient specimens overlapping control lots different shift control specimens different brand of controls precision check specimens, etc. Using &' ) (1 values for each parameter (up to 18), with mean/limits, or upper and lower range, can be entered for each file. In addition, data can be copied from a replicate file into a designated control file. NOTE 2-18 Prior to data copy, any run data in the designated control file must be purged using & '%( for that control. CELL-DYN® 1600 Operator's Manual 9140214 Rev D— June 1993 SEARCH BOOK TOC GO BACK To Enter Flag Information 1. At the.05.0, press &' ) (. The '' # 2" message displays in the Status Box. 2. Enter the replicate file number. The .+ $.;;*+..0screen displays. 3. IS THE LOT NUMBER ENTRY ACCEPTABLE? YES Press . Go to step 4. NO NOTE Type lot number, or other identifier, up to nine digits. Press to store data and advance the cursor. This field accepts only numeric data. If the lot number is less than 9 digits, press to advance the cursor. 4. IS THE EXPIRATION DATE ENTRY ACCEPTABLE? YES Press 0 Go to step 5. NO 5. Type the expiration date (using MM/DD/YY) from the control vial or assay sheet. IS THE WESTGARD RULE SELECTION ACCEPTABLE? YES Go to step 6. NO Set the cursor at the rule requiring change. Press . Repeat this process until all rule selections are acceptable. Go to step 6. 6. REVIEW RANGE OR MEAN/LIMITS? YES Press &'#%( or &#+ )( to display the screen for the selected control file. Go to step 7. NO CELL-DYN® 1600 Operator's Manual 9140214 Rev D— June 1993 Press &) ( to return to .05.0. 2-19 SEARCH BOOK TOC GO BACK 7. ARE THE VALUES ACCEPTABLE? YES Go to step 8. NO Use the #* keys to move the cursor to the first value to be changed and type the new value. If the value contains less than three digits, press the key to store the data and advance the cursor. Repeat this process until all values are entered and acceptable. Go to step 8. NOTE Refer to the Quality Control chapter for the established Replicate Specimen Mean Values. 8. IS A PRINTOUT REQUIRED? YES Press & ' (. NO 9. Go to step 9. IS ANOTHER REPLICATE FILE REQUIRED? YES Press &''(. Repeat steps 2-9 for each file, as required. NO 2-20 Press &''( then &) ( to return to .05.0 screen. CELL-DYN® 1600 Operator's Manual 9140214 Rev D— June 1993 SEARCH BOOK TOC GO BACK X-B File Setup Key Calculated data for each batch (20 specimens) is compared to an established X-B target and limits to determine if the X-B batch data is acceptable. To eliminate bias from grossly abnormal specimen results, data acceptance limits are set, via the <3 *+..0 screen, to automatically exclude these specimens from the program. To Use the X-B Function 1. At the .05.0, press &34) (. The <3*+..0 screen displays, and the cursor is on the first MCV limit. 2. ARE THE VALUES ACCEPTABLE? YES Press &) ( to return to .05.0 screen. NO Move the cursor to the first value to be changed and type the new value. If the value contains less than 3 digits, press the key to store the data and advance the cursor. Repeat this process until all values are entered and acceptable. 3. Press &) ( to return to .05.0 screen. Auto-Startup Cycle The Auto-Startup cycle activates anytime the &'( key is pressed and either +++$+1.2 or $234 displays in the Status Box. The cycle is designed to prime the flow system and check the background before specimens are run. Upon completion of the cycle, the 0 screen displays with the background check results. A background is run in order to monitor the quantity of particles present in reagents and the flow system. CELL-DYN® 1600 Operator's Manual 9140214 Rev D— June 1993 2-21 SEARCH BOOK TOC GO BACK At installation, perform multiple run cycles to thoroughly prime and purge any particles from the flow system. During each cycle, the computer monitors the time required for each measurement, referred to as the count time. A value for this time displays in seconds to the right of the histograms. The count time is used to monitor fluid flow, to detect the presence of partial restrictions in either aperture and/or the presence of air in either metering tube. Cell sizing can be affected by either of these conditions. To Actuate the Auto-Startup Cycle The message # 1 # $" must be displayed in the Status Box of the 5$+5.0 screen. 1. To start the cycle, press &']. 2. The message '1'#!"displays in the Status Box when the cycle is complete. 3. Press &) ! ( to display the next screen. 4. Press &,'#4#-%',(. The 5$+05.0 displays. 5. Press the touch plate to start the cycle - no specimen is required. 6. Repeat step 5 until acceptable background and count time data (see Table 2-3) are obtained for three consecutive cycles. ) $3=88 2 3=8 /3 ""%-90 %"">"" 3 ""%590 ?"">"" &:3 "" 98 ""-90 This completes initial installation power on, system setup, and initial prime procedures. Calibration is the next procedure when installing an analyzer. 2-22 CELL-DYN® 1600 Operator's Manual 9140214 Rev D— June 1993 SEARCH BOOK TOC GO BACK Chapter 3 Principles of Operation Principles of Operation Introduction The principles that the CELL-DYN® 1600 uses to measure, count, and calculate the hematologic parameters are discussed generally in the first section of this chapter. The parameters are discussed individually and a detailed explanation of the theory used for parameter derivation in each of two methods is given in the last section. The two independent measurement methods used in the CELL-DYN 1600 are: the impedance method for determining the WBC, RBC, and PLT data the modified cyanmethemoglobin method for determining the HGB During each instrument cycle, the sample is aspirated, diluted and mixed before the measurements for each parameter are performed. Sample Analysis Cycle Overview Aspiration The CELL-DYN 1600 uses the open sampler mode to aspirate 30 microliters of whole blood from a collection tube that has been opened and held under the specimen probe. Dilution A 7.5 mL volume of diluent is added in the pre-mix cup to achieve a ratio of 1:251. Whole blood pre-diluted with diluent to a ratio of 1:251 can also be used as a sample in the Pre-Dilute mode (40 )L of sample to 10 mL of diluent). The diluted sample is then divided into two samples. CELL-DYN® 1600 Operator's Manual 9140214 Rev E—February 1994 100 microliters of the 1:251 sample dilution are aspirated and mixed with an addition of 5 mL of diluent in the RBC/PLT dilution bath to a ratio of 1:12801. The 1:12801 dilution is used to analyze the red cell and the platelet parameters. The remainder of the 1:251 dilution is mixed with 1.0 (± 0.25) mL of lyse reagent in the WBC dilution bath. The lyse reagent changes the membrane of each red cell causing cytoplasm and hemoglobin to be quickly released. The red cell membrane (ghost) that remains is less than 2 femtoliters. 3-1 SEARCH BOOK TOC GO BACK Principles of Operation WBC Analysis Chapter 3 The lyse reagent also compresses the membrane of each white cell (leukocyte). This causes cytoplasm to slowly diffuse from the cell as the membrane shrinks around the nucleus and any cytoplasmic granules that may be present. This dilution is used to measure the number and modified size of the white cells and the amount of hemoglobin released. Volumetric metering is used in both the WBC dilution bath and the RBC dilution bath to ensure that a precise amount of diluted specimen is measured during each count cycle. Electrical impedance is used to count the white blood cells as they pass through the aperture in the WBC transducer. As each cell is drawn through the aperture, a change in electrical resistance occurs generating an equivalent voltage pulse. The number of pulses sensed during each cycle corresponds to the number of white cells counted. The amplitude of each pulse is directly proportional to the volume of the cell it represents. The CELL-DYN 1600 uses electronic sizing to determine three distinct white cell subpopulations. Cells correlating to lymphocytes are included in the small cell subpopulation. Cells correlating to granulocytes are included in the large cell population. The remaining cells correlating to monocytes, eosinophils, basophils, blasts, and other precursor white cells are generally included in the mid-size cell population. RBC/PLT Analysis The 1:12801 dilution is pulled through the aperture of the transducer bath where electrical impedance is used to count the red blood cells and platelets as they pass through the aperture. Hemoglobin Analysis After the WBCs have been counted and sized, the remainder of the lysed dilution is transferred to the HGB flow cell. In the flow cell, the CELL-DYN 1600 measures the ability of the dilution to absorb light at a wavelength of 540 nm. The result is reported as a measured weight per volume of whole blood; for example, HGB xx.x g/dL refers to xx.x grams of hemoglobin per deciliter of whole blood. Results Displayed 3-2 All data are transferred to the CELL-DYN 1600 computer for processing. Results are displayed on the video display monitor RUN MENU. Size distribution data for lysemodified WBCs and subpopulations, for RBCs and PLTs are displayed as histograms. The corresponding results from each count are displayed to the left of each histogram. CELL-DYN® 1600 Operator's Manual 9140214 Rev E—February 1994 SEARCH BOOK TOC GO BACK Chapter 3 Principles of Operation MCV, HCT, RDW Determination The CELL-DYN 1600 determines the mean cell volume (MCV) from the red cell size distribution data and reports it in fL. The result for hematocrit is calculated from the red cell count and the mean cell volume value using the following formula: HCT (hematocrit) = (RBC * MCV) / 10 Red cell distribution width (RDW) is the coefficient of variation of red cell heterogeneity determined from the red cell size distribution data. MPV, PCT, PDW Determination An algorithm is used to analyze the platelet histogram to obtain the mean platelet volume (MPV). Each MPV xx.x fL result is reported directly in femtoliters. A result for plateletcrit is calculated from the platelet count and mean platelet volume as follows: PCT = (PLT * MPV) / 10 Each PCT x.xx mL/L result is reported as milliliters per liter. Platelet distribution width (PDW) is the geometric standard deviation (GSD) of the platelet size distribution. Each PDW xx.x 10(GSD) result is derived from the platelet histogram data and is reported as 10(GSD). MCH and MCHC Determination Values for the mean cell hemoglobin (MCH) and the mean cell hemoglobin concentration (MCHC) are calculated automatically whenever appropriate parameters are measured, e.g., red cell count, hematocrit, and hemoglobin. The following formulas apply: MCH (mean cell hemoglobin) = (HGB/RBC) * 10 MCHC (mean cell hemoglobin concentration) = (HGB/HCT) * 100 Each MCH xx.x pg result is reported in picograms. Each MCHC xx.x g/dL is reported as grams per deciliter. Data Storage Up to 320 run cycles are automatically stored in a Data Log on the system diskette. CELL-DYN® 1600 Operator's Manual 9140214 Rev E—February 1994 3-3 SEARCH BOOK TOC GO BACK Principles of Operation Instrument Rinsed Chapter 3 After each run cycle, each element of the instrument is rinsed. The open sample specimen probe is rinsed internally and externally with diluent. The WBC dilution bath is rinsed with diluent. The RBC/PLT dilution bath is rinsed with diluent. The HGB flow cell is rinsed with detergent. WBC Measurement Process Overview The WBC impedance method is used for the determination of WBC data. Cells are counted and sized as they pass through the aperture of the WBC transducer. Electrical Impedance Measurements WBCs are counted and sized by the Aperture Impedance method. This method is based on the measurement of changes in electrical resistance produced by a particle suspended in a conductive diluent as it passes through an aperture of known dimensions. An electrode is submerged in the liquid on both sides of the aperture to create an electrical pathway. As each particle passes through the aperture, a transitory change in the resistance between the electrodes is produced. This change produces a measurable electrical pulse. The number of pulses generated is indicative of the number of particles that passed through the aperture. The amplitude of each pulse is essentially proportional to the volume of each particle. Each pulse is amplified and compared to internal reference voltage channels. These channels are delineated by calibrated size discriminators to accept only pulses of a certain amplitude. Thus, the pulses are sorted into various size channels according to their amplitude. Volumetric Metering An accurate cell count cannot be obtained unless the precise volume of diluted whole blood that passes through the aperture during the count cycle is known.1 The CELL-DYN 1600 uses the Volumetric Metering process to regulate the count cycle and to make sure that a precise volume of sample is analyzed for the measurement. The WBC Metering Assembly contains a precision-bore glass tube fitted with two optical detectors. This tube ensures that a precise amount of diluted specimen is measured during each count cycle. The exact amount is determined by the distance between the two optical detectors. 3-4 CELL-DYN® 1600 Operator's Manual 9140214 Rev E—February 1994 SEARCH BOOK TOC GO BACK Chapter 3 Principles of Operation Detergent is used to create a meniscus in the metering tube. The count portion of the cycle is initiated when the meniscus reaches the upper detector. The count cycle stops when the meniscus reaches the lower detector. The amount of time required for the meniscus to travel from the upper detector to the lower detector is called the Count Time and is measured in seconds. This is displayed on the RUN MENU. The computer monitors the count time to detect any variation from the expected values. Variation may be caused by debris in the aperture, vacuum fluctuation or air bubbles in the metering tube. If significant variation is detected, the RUN MENU displays the message <CLOG> or <FLOW ERROR>, and no WBC and differential data are displayed. A Clog indicates the flow was too slow, most likely caused by debris in the aperture. Flow errors indicate the flow was too fast, often caused by bubbles in the metering tube. WBC Measurement The 1:251 WBC/HGB dilution is delivered to the WBC dilution bath where it is bubble mixed with 1.0 (± 0.25) mL of lyse reagent. A metered volume of the lysed sample is drawn through the aperture by vacuum. The WBCs are counted by impedance. If the pulse generated is above the WBC lower threshold, it is counted as a WBC. The von Behrens plate located in the WBC transducer counting chamber minimizes the effect of recirculating cells. As cells exit from the aperture, they tend to swirl around and may re-enter the sensing zone and be counted a second time. This causes the counts to be falsely elevated. Coincidence Passage Correction Two or more cells can enter the aperture sensing zone simultaneously during a measurement cycle. The resistance change created in this situation generates a single pulse with a high amplitude and increased pulse area. Thus, it appears that one large cell has passed through the aperture. Consequently, the cell count is falsely decreased. This count reduction, referred to as Coincidence Passage loss, is statistically predictable because it has a direct relationship to the effective volume of the aperture and the amount of dilution. Each total cell count is automatically corrected for coincidence passage loss. WBC Parameters WBC Histograms The WBC data are plotted in a histogram format with the relative number of cells on the Y axis and the WBC size distribution data on the X axis. Results of each count are displayed to the left of the histogram on the RUN MENU. CELL-DYN® 1600 Operator's Manual 9140214 Rev E—February 1994 3-5 SEARCH BOOK TOC GO BACK Principles of Operation Chapter 3 Once the WBC count is determined, the absolute number of cells in each subpopulation is calculated by multiplying that WBC count by the percentage. The results are expressed as follows: WBC LYM GRAN MID # K / )L # K / )L and % # K / )L and % # K / )L and % RBC/PLT Measurement Process Overview The impedance method is used for the determination of RBC and PLT data. Cells are counted and sized as they pass through the aperture of the RBC/PLT transducer. Electrical Impedance Measurements RBCs and PLTs are counted and sized by the Aperture Impedance method. This method is based on the measurement of changes in electrical resistance produced by a particle suspended in a conductive diluent as it passes through an aperture of known dimensions. An electrode is submerged in the liquid on both sides of the aperture to create an electrical pathway. As each particle passes through the aperture, a transitory change in the resistance between the electrodes is produced. This change produces a measurable electrical pulse. The number of pulses generated is indicative of the number of particles that passed through the aperture. The amplitude of each pulse is essentially proportional to the volume of each particle. Each pulse is amplified and compared to internal reference voltage channels. These channels are delineated by calibrated size discriminators to accept only pulses of a certain amplitude. Thus, the pulses are sorted into various size channels according to their amplitude. Coincidence Passage Correction Two or more cells can enter the aperture sensing zone simultaneously during a measurement cycle. The resistance change created in this situation generates a single pulse with a high amplitude and increased pulse area. Thus, it appears that one large cell has passed through the aperture. Consequently, the cell count is falsely decreased. This count reduction, referred to as Coincidence Passage loss, is statistically predictable because it has a direct relationship to the effective volume of the aperture and the amount of dilution. Each total cell count is automatically corrected for coincidence passage loss. 3-6 CELL-DYN® 1600 Operator's Manual 9140214 Rev E—February 1994 SEARCH BOOK TOC GO BACK Chapter 3 Principles of Operation Volumetric Metering An accurate cell count cannot be obtained unless the precise volume of diluted whole blood that passes through the aperture during the count cycle is known.1 The CELL-DYN 1600 uses the Volumetric Metering process to regulate the count cycle and to make sure that a precise volume of sample is analyzed for the measurement. The RBC/PLT Metering Assembly contains a precision-bore glass tube fitted with two optical detectors. This tube ensures that a precise amount of diluted specimen is measured during each count cycle. The exact amount is determined by the distance between the two optical detectors. Detergent is used to create a meniscus in the metering tube. The count portion of the cycle is initiated when the meniscus reaches the upper detector. The count cycle stops when the meniscus reaches the lower detector. The amount of time required for the meniscus to travel from the upper detector to the lower detector is called the Count Time and is measured in seconds. This is displayed on the RUN MENU. The computer monitors the count time to detect any variation from the expected values. Variation may be caused by debris in the aperture, vacuum fluctuation or air bubbles in the metering tube. If significant variation is detected, the RUN MENU displays the message <CLOG> or <FLOW ERROR>, and no RBC/PLT and differential data are displayed. A Clog indicates the flow was too slow, most likely caused by debris in the aperture. Flow errors indicate the flow was too fast, often caused by bubbles in the metering tube. RBC/PLT Measurement The 1:12801 RBC/PLT dilution is delivered to the RBC/PLT dilution bath where it is bubble mixed. A precise volume of the diluted specimen is drawn through the aperture by vacuum. The RBCs and PLTs are counted by impedance. If the pulse generated is above the PLT lower threshold, it is counted as a PLT. If the pulse generated is above the RBC lower threshold, it is counted as an RBC. The von Behrens plate located in the RBC/PLT transducer counting chamber minimizes the effect of recirculating cells. As cells exit from the aperture, they tend to swirl around and may re-enter the sensing zone and be counted a second time. This causes the counts to be falsely elevated. CELL-DYN® 1600 Operator's Manual 9140214 Rev E—February 1994 3-7 SEARCH BOOK TOC GO BACK Principles of Operation Chapter 3 RBC Parameters RBC Histograms The RBC data are plotted in a histogram format with the relative number of cells on the Y axis and the RBC size distribution data on the X axis. Results of each count are displayed to the left of the histogram. RBC Count The RBC count is measured directly. The number of RBCs is expressed as follows: RBC = # M / )L MCV The Mean Cell Volume is the average volume of the individual red blood cells. The MCV is derived from the RBC size distribution data and is expressed in femtoliters. HCT The Hematocrit is the ratio of red blood cells to plasma and is expressed as a percentage of the whole blood volume. The HCT is calculated from the red blood cell count and the mean cell volume as follows: HCT = (RBC * MCV) / 10 MCH The Mean Cell Hemoglobin is the average amount of hemoglobin contained in the red blood cell expressed as picograms. The MCH is calculated from the RBC and HGB as follows: MCH = (HGB/RBC) * 10 MCHC The Mean Cell Hemoglobin Concentration is the ratio of the weight of hemoglobin to the volume of the average red blood cell expressed in percent. It is calculated from the HGB and the HCT as follows: MCHC = (HGB/HCT) * 100 RDW Red Cell Distribution Width is a measure of the heterogeneity of the RBC population. The CELL-DYN 1600 reports RDW as a percent coefficient of variation. The RDW is derived from the RBC histogram. RBC Flagging Refer to the Operational Messages and Data Flagging section of this chapter for RBC Flagging Information. 3-8 CELL-DYN® 1600 Operator's Manual 9140214 Rev E—February 1994 SEARCH BOOK TOC GO BACK Chapter 3 Principles of Operation PLT Measurement Introduction Pulses counted in the RBC/PLT dilution between 1 and 35 fL are included in the PLT data. If the raw PLT count is estimated to be below a predetermined value, the instrument automatically continues to count PLTs for an extended count period. The results from the two count periods are averaged. The PLT data are plotted as a histogram. An algorithm analyzes the histogram to eliminate interference and thus determine the lower and upper thresholds for the count. If no interference is detected, the lower and upper thresholds are set at 2 and 35 fL, respectively. If interference is detected, the thresholds float to determine the best separation between the interference and the PLT population. The lower threshold floats in the 1 - 3 fL region, and the upper threshold floats in the 15 - 35 fL region. Once the thresholds have been determined, the PLT count is derived from the data between them. Interference in the upper threshold region is generally caused by microcytic RBCs. Therefore, after the PLT upper threshold has been determined, the data between it and the RBC lower threshold are re-evaluated. If the PLT upper threshold is less than 35 fL, the count above it (but less than the RBC lower threshold) is added to the RBC count. If the interference in either threshold region exceeds a predetermined limit, the PLT count is flagged accordingly. The flags are discussed in the last section of this chapter. PLT Parameters PLT Histogram The PLT data are plotted in a histogram format with the relative number of cells on the Y axis and the PLT size distribution data on the X axis. Results of each count are displayed to the left of the histogram. PLT Count The Platelet Count is derived from the PLT histogram after the PLT data have been analyzed by the platelet algorithm. The PLT count is expressed as follows: PLT = # K / )L MPV The Mean Platelet Volume is derived from the PLT histogram after the PLT count has been determined. The MPV is expressed in femtoliters. CELL-DYN® 1600 Operator's Manual 9140214 Rev E—February 1994 3-9 SEARCH BOOK TOC GO BACK Principles of Operation PCT Chapter 3 The Plateletcrit is the product of the PLT and MPV and is analogous to the hematocrit. It is expressed in percent and is calculated as follows: PCT = (PLT * MPV) / 10 PDW Platelet Distribution Width is a measure of the heterogeneity of the PLT population. It is expressed as a geometric standard deviation. NOTE PLT Flagging PCT and PDW are not reportable. Refer to the Operational Messages and Data Flagging section of this chapter for PLT flagging information. Hemoglobin Measurement Overview The modified cyanmethemoglobin method is used for the colorimetric determination of hemoglobin. A sample of the lyse diluted sample from the WBC dilution bath is used for the HGB measurement. A low-energy LED is used as the light source. A filtered photodetector with a wavelength of 540 nm measures the transmitted light. Hemoglobin Measurement Process The Lytic Agent lyses the diluted red blood cells and converts the hemoglobin that is released to a cyanide-containing pigment. After the WBC count is completed, the sample is transferred to the Hemoglobin flow cell where the hemoglobin concentration is measured. The sample enters the flow cell from the bottom. This allows any bubbles present to exit the flow cell so they will not interfere with the reading. The LED shines through the flow cell and a 540 nm narrow bandwidth filter onto a photodetector. The hemoglobin concentration is directly proportional to the absorbance of the sample at 540 nm. After the hemoglobin reading has been made the HGB flow cell is rinsed with detergent. The rinse is drained and more detergent is delivered to the flow cell. A zero or blank reading is then obtained on the detergent to provide a reference to which the sample signal is compared. The reference and sample readings are compared to determine the HGB concentration of the sample. The HGB result is expressed in grams of hemoglobin per deciliter of whole blood. 3-10 CELL-DYN® 1600 Operator's Manual 9140214 Rev E—February 1994 SEARCH BOOK TOC GO BACK Chapter 3 HGB Flagging Principles of Operation Refer to the Operational Messages and Data Flagging section of this chapter for HGB flagging information. Operational Messages and Data Flagging Introduction Operational messages and data flags appear on the RUN MENU and on printed reports. The CELL-DYN 1600 monitors condition and data criteria that may affect the displayed results, and these messages and flags are used to alert the operator. Instructions for interpreting all flags, numeric, and histogram data should be incorporated into the laboratory's procedure and used to determine the need for further action and/or review of results. Messages are divided into the following categories: Instrument Messages: Fault Conditions Status Conditions Parameter Flagging Messages: Dispersional Data Alerts Suspect Parameter Messages Suspect Population Flags Instrument Fault and Status Conditions The Instrument Fault and Status conditions are discussed in Chapter 10, Troubleshooting. These messages are displayed when the instrument detects an inappropriate condition during specimen processing. When necessary, data are suppressed. When any of these messages are displayed, refer to Chapter 10, Troubleshooting, for assistance. Follow the instructions given and take the appropriate corrective action. When the problem is corrected, repeat the specimen. Parameter Flagging Messages Dispersional Data Alerts These alerts are triggered by the numeric limits entered into the Patient Limit Sets (see the Set Up Instructions section of Chapter 5, Operating Instructions, for an explanation) or taken from the instrument's preset linearity limits. If results for a parameter exceed these limits, they are flagged on the screen and on the report. CELL-DYN® 1600 Operator's Manual 9140214 Rev E—February 1994 3-11 SEARCH BOOK TOC GO BACK Principles of Operation Chapter 3 Alert messages pertaining to specimens, either patient or QC, are displayed in place of or next to the affected result(s). All RUN, DATA LOG, and QC results for the affected parameter(s) are displayed in inverse video and underlined on the printout. The name of each flag, the location of the flag on the display, the cause of the flag, and the action to be taken are given in the following explanations. Flag: xxx (displayed in inverse video) Cause: The parameter result is outside of operator-entered limits. Action: Confirm background. Rerun the specimen and review a stained smear to confirm the results. Flag: (no display) Cause: No result is displayed when the measurement count time is unacceptable. A message pertaining to the probable cause displays to the right of the affected measurement histogram. When the time for fluid to reach either detector is too long, <CLOG> is displayed. When the time to reach either detector is too short, <FLOW ERROR> is displayed. Action: Press [CLEAR ORIFICE]. Rerun the specimen when the system is ready. If <CLOG> appears again, follow the instructions in Chapter 9, Maintenance, to clean the transducers. If <FLOW ERROR> appears again, go to Special Protocols. Press [MORE]. Press [PRIME REAGENT] to fill the flow system. Or, consult Chapter 10, Troubleshooting. Suspect Parameter Flags These flags are generated after the instrument evaluates the measured data for a particular parameter or group of parameters. The result may be suspect due to interfering substances or the inability of the instrument to measure a particular parameter due to a sample abnormality. The name of each flag, the location of the flag on the display, the cause of the flag, and the action to be taken are given in the following explanations: Flag: LRI (Lower Region Interference) Cause: Interference in the lower threshold region (1 - 3 fL) is greater than the predetermined limit. This is generally non-biologic interference. The flag may be caused by: Debris (dirty aperture) Contaminated reagent Electronic noise Microbubbles 3-12 CELL-DYN® 1600 Operator's Manual 9140214 Rev E—February 1994 SEARCH BOOK TOC GO BACK Chapter 3 Principles of Operation Action: Check the background count. If it exceeds the limits, troubleshoot accordingly. If it is within limits, repeat the specimen. If the flag persists, review a stained smear to determine the cause of the interference and verify the PLT count. Flag: URI (Upper Region Interference) Cause: Interference in the upper threshold region (15 - 35 fL) is greater than a predetermined limit. This is generally biologic interference. This flag may be caused by: Microcytic RBCs Schistocytes Giant Platelets Sickle Cells Platelet Clumps NOTE A "bumpy" platelet histogram may indicate the presence of platelet clumps. Action: Review the MCV and the PLT histogram. If the MCV is low and/or the histogram indicates an overlap (poor separation in the upper discriminator) in the RBC and PLT populations, review a stained smear to determine the cause and confirm the PLT count. Suspect Population Flags These flags are generated when the instrument's evaluation of the measured data for a particular parameter or group of parameters indicates the possible presence of an abnormal subpopulation. A stained smear should be reviewed whenever a suspect population flag is present. Therefore, instructions for interpreting flags should be incorporated into the laboratory's review criteria for abnormal samples. Flag: LYM R0 or RM (Displays and prints after the percent [L%] result.) Cause: LYM data in the region to the left of 35 fL are outside the normal criteria. Action: Check the whole blood for clots or agglutination. Redraw and rerun the specimen as required. Review a stained smear to confirm the results. This flag may be caused by: Nucleated RBCs Platelet clumps Giant Platelets Cryoglobulins Incomplete lysis of red cells CELL-DYN® 1600 Operator's Manual 9140214 Rev E—February 1994 3-13 SEARCH BOOK TOC GO BACK Principles of Operation Chapter 3 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 specimen as required. Review a stained smear to confirm the results. This flag may be caused by: Lymphocytosis Lymphopenia Cryoglobulins 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 specimen as required. Review a stained smear to confirm the results. This flag may be caused by: Lymphocytosis Lymphopenia Blasts/Plasma Cells Variant lymphocytes Basophilia Flag: MID R3 or RM (Displays between absolute and percent results.) Cause: LYM data in the region to the left of 135 fL are outside normal criteria. Action: Check the whole blood specimen for clots or agglutination. Redraw and rerun the specimen as required. Review a stained smear to confirm results. This flag may be caused by: Eosinophilia Blast/Plasma Cells Agranular neutrophils Platelet clumps (occasionally) Basophilia Bands Flag: GRAN R3 or RM (Displays between the absolute and percent results.) Cause: GRAN data in the region to the right of 135 fL are outside the normal criteria. 3-14 CELL-DYN® 1600 Operator's Manual 9140214 Rev E—February 1994 SEARCH BOOK TOC GO BACK Chapter 3 Principles of Operation Action: Check the whole blood specimen 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: Granulocytosis Decreased lytic action Neutropenia Flag: WBC R4 (Displays to the right of the total WBC result.) Cause: Flag will be activated if the total WBC count is > 30K/)L and the mean channel location is above 150 fL, or if the mean channel location exceeds 287 fL. Action: Check the whole blood specimen for clots or agglutination. Redraw and rerun the specimen as required. Review a stained smear to confirm results. This flag may be caused by: Monocytosis Basophilia Eosinophilia Blast/Plasma cells Increased bands Granulocytosis Agranular neutrophils Variant (atypical) lymphocytes Neutropenia Platelet clumps (large) Abnormal lytic action References 1. CELL-DYN® 1600 Operator's Manual 9140214 Rev E—February 1994 ICSH, The Assignment of Values to Fresh Blood used for Calibrating Automated Cell Counters, Clinical and Laboratory Hematology 1988, 10:203-212. 3-15 SEARCH BOOK TOC GO BACK Principles of Operation 3-16 Chapter 3 CELL-DYN® 1600 Operator's Manual 9140214 Rev E—February 1994 SEARCH BOOK TOC GO BACK Chapter 4 System Specifications System Specifications CELL-DYN® 1600 Physical Specifications Table 4-1 Dimensions Dimension Analyzer Graphics Printer Height 18" (46 cm) 4" (10 cm) Width 33" (84 cm) 17" (43 cm) Depth 20" (51 cm) 23" (58 cm) CS model 14" (35 cm) Weight 145 lbs (66 Kg) 17 lbs (7.5 kg) Table 4-2 Dimensions After Packaging for Shipment Dimension Analyzer Graphics Printer Height 30" (76 cm) 9" (23 cm) Width 42" (107 cm) 22" (56 cm) Depth 32" (81 cm) 20" (51 cm) Weight 200 lbs (91 kg) 35 lbs (16 kg) Data Module Data Display 14-inch (diagonal) monochrome video display screen with amber illumination. It provides alphanumeric display of all data, screen labels, system and specimen alerts. Membrane Keypad The membrane keypad consists of pressure sensitive keys, each with an audible beep indicator. A numeric and special function keypad is located directly below the row of eight unlabeled keys. Each key generates an audible tone when pressed. This membrane keypad contains the following numeric and special function keys: CELL-DYN® 1600 Operator's Manual 9140214 Rev E—February 1994 Numeric Keys — a block of ten numeric keys, labeled from 0 to 9, which are used to enter numeric data ENTER Key — stores entered numeric data and advances the cursor to the next entry location 4-1 SEARCH BOOK TOC GO BACK System Specifications Graphic Printer Chapter 4 Asterisk (*) Key — allows the operator to escape (abort) data entry before it is completed Arrow Keys — a set of four keys used to move the cursor in the direction depicted by each arrow Pound (#) Key — used for service functions only An external dot matrix printer provides alphanumeric and graphic reports for displayed and stored data. Power Specifications Table 4-3 Power Specifications Analyzer Input Requirements Range Frequency 90 - 125 VAC 50/60 Hz 195 - 259 VAC 50 Hz Printer Input Requirements (Ticket or Graphics) Setting Frequency 120 VAC 50/60 Hz Power Consumption Analyzer: 1000 Watts Maximum (3200 BTU per hour) Operational Specifications Operating Environment Temperature: Relative Humidity: 150C to 300C (590F to 860F) 10% to 85%, RHNC Complete Cycle Times (READY to READY) 4-2 Auto-Startup: Run: Extended Run: Auto-Calibration: Auto-Shutdown: 120 60 75 150 120 +/+/+/+/+/- 20 seconds 15 seconds 15 seconds 15 seconds 20 seconds CELL-DYN® 1600 Operator's Manual 9140214 Rev E—February 1994 SEARCH BOOK TOC GO BACK Chapter 4 System Specifications Aspiration Volumes (whole blood) Open Mode: Pre-Dilute Mode: 30 L 40 L Measurement Specifications Measurement Channels Two impedance channels, one for WBC impedance count and one for RBC and PLT. WBC and Differential Method: Aperture Size: Dilution: Impedance with volumetric metering 100 m in diameter x 60 m in length One part whole blood in 250 parts diluent plus 1.0 ± 0.25 mL lyse reagent. Method: Aperture Size: Dilution: Impedance with volumetric metering 60 m in diameter x 70 m in length One part whole blood in 12,800 parts of diluent. Method: Light Source: Wavelength: Dilution: Modified cyanmethemoglobin with autoblank LED 540 nm One part whole blood in 250 parts diluent plus 1.0 ± 0.25 mL lyse reagent. RBCs and PLTs HGB Performance Specifications Linearity Linearity specifications were determined by analyzing dilutions of commercially available control material or patient samples that contain no interfering substances and display no suspect flags. Specifications were determined by taking multiple measurements on each dilution to minimize the effect of imprecision. The stated limits (see Table 4-4) were determined by regression analysis through the origin (0,0). CELL-DYN® 1600 Operator's Manual 9140214 Rev E—February 1994 4-3 SEARCH BOOK TOC GO BACK System Specifications Chapter 4 Table 4-4 Linearity Specifications Parameter Linear Range Allowable Limit +/- WBC* 1.0 - 99.9 K/L +/- 0.4 or 3.0% RBC 1.00 - 7.00 M/L +/- 0.1 or 2.5% HGB 2.5 - 24.0 g/dL +/- 0.3 or 2.0% MCV 50 - 200 fL +/- 3.0 or 3.0% HCT 10.0 - 70.0% +/- 1.0 or 2.5% PLT 10 - 999 K/L +/- 12 or 4.0% *Linearity specification determined by use of commercially available control material. Accuracy The CELL-DYN 1600 system can be calibrated to agree with reference values within the allowable calibration ranges. Both modes of operation, open and closed, may be calibrated. Thus, it is possible to compensate for differences between modes due to differing aspiration pathways or operational sequences. When each mode is properly calibrated according to directions given in this manual, bias between the modes is clinically insignificant. Greater than 0.98 correlation was obtained to reference methods and/or comparison analyzer values for WBC, RBC, HGB, PLT, MCV, and HCT. Greater than 0.92 correlation was obtained to comparison analyzer values for RDW, MPV, LYM and GRAN. Greater than 0.60 correlation was obtained to comparison analyzer values for MID. Correlation data were not run for PDW and PCT. Accuracy is verified by correlation to reference values obtained from comparison analyzers or by reference methodology. Samples that are used for correlation studies should not display any suspect flags. Precision "Within Sample" precision checks routine instrument operation. It is determined as the coefficient of variation (CV) for results obtained by running the same specimen consecutively 20 to 30 times. Typical and absolute "Within Sample" precision data for the CELL-DYN 1600 are shown in Table 45. "Within Day" precision checks short term calibration stability. It is based on the coefficient of variation for results obtained by running the same specimen randomly 20 to 30 times during a 24 hour period. Typical "Within Day" precision data for the CELL-DYN 1600 are provided in Table 4-5. 4-4 CELL-DYN® 1600 Operator's Manual 9140214 Rev E—February 1994 SEARCH BOOK TOC GO BACK Chapter 4 System Specifications "Day to Day" precision checks long term calibration stability. It is based on the coefficient of variation for results obtained by running the same lot of commercial control 20 to 30 times during a 10 day or longer period. Typical "Day to Day" precision data are provided in Table 4-5. NOTE Any system component change (e.g. recalibration, reagent brand or lot, etc.) during this period can affect the results. Table 4-5 Precision at 250C 1 2 3 4 Parameter Typical1 within Sample Typical2 within Day Typical3 Day to Day Absolute4 within Sample WBC (K/L) CV 4.6 - 10.2 2.3% 4.6 - 10.2 2.7% 4.6 - 10.2 3.2% 4.6 - 10.2 2.5% LYM (K/L) CV 0.6 - 4.1 8.0% 0.6 - 4.1 8.5% 0.6 - 4.1 9.0% 0.6 - 4.1 8.0% GRAN (K/L) CV 2.0 - 7.8 7.0% 2.0 - 7.8 7.5% 2.0 - 7.8 8.0% 2.0 - 7.8 7.0% RBC (M/L) CV 4.04 - 6.13 1.2% 4.04 - 6.13 1.5% 4.04 - 6.13 2.0% 4.04 - 6.13 1.7% HGB (g/dL) CV 12.2 - 18.1 1.0% 12.2 - 18.1 1.2% 12.2 - 18.1 1.5% 12.2 - 18.1 1.2% HCT (vol %) CV 37.7 - 53.7 1.5% 37.7 - 53.7 1.7% 37.7 - 53.7 2.0% 37.7 - 53.7 1.7% MCV (fL) CV 80 - 100 1.0% 80 - 100 1.2% 80 - 100 1.7% 80 - 100 1.5% RDW (%) CV 10.6 - 14.8 3.0% 10.6 - 14.8 3.5% 10.6 - 14.8 4.0% 10.6 - 14.8 3.5% PLT (K/L) CV 142 - 424 5.5% 142 - 424 6.0% 142 - 424 7.5% 142 - 424 6.0% MPV (fL) CV 7.5 - 12.5 6.0% 7.5 - 12.5 6.5% 7.5 - 12.5 7.5% 7.5 - 12.5 6.0% Within Sample Protocol: 1 specimen run consecutively 20 times Within Day Protocol: 1 specimen run randomly 20 times within a 24-hour period Day to Day Protocol: 1 specimen run 20 times 10 consecutive days Expected performance at a 95% confidence limit CELL-DYN® 1600 Operator's Manual 9140214 Rev E—February 1994 4-5 SEARCH BOOK TOC GO BACK System Specifications 4-6 Chapter 4 CELL-DYN® 1600 Operator's Manual 9140214 Rev E—February 1994 SEARCH BOOK TOC GO BACK Chapter 5 Operating Instructions Operating Instructions Introduction This chapter discusses the operation of the CELL-DYN® 1600. It is divided into 7 sections: ! ! ! ! ! ! ! Routine Operation Setup System Operation Specimen Collection and Handling Sample Analysis Daily Shutdown Power Off Procedure Using the Data Log The chapter also includes an overview of the Data Module program. The major menus in the program that are used for routine operation — Run and the Data Log — are discussed in this chapter. The remaining parts of the program are discussed in the following chapters: Setup Calibration Quality Control Special Protocols Diagnostics Chapter 2 Chapter 6 Chapter 7 Chapter 9 Chapter 10 Data Module Program Overview The Data Module menus are presented as key labels displayed across the bottom of the screen. Each menu is accessed by pressing the key located directly below the label. When the data module is powered ON, the MAIN MENU is displayed. The key labels displayed across the bottom of this screen are used to access all of the sub-menus that are available. The MAIN MENU keys are listed below: [SETUP] [RUN] [DATA LOG] [QC] [CALIBRATION] [DIAGNOSTICS] [HELP] [SPECIAL PROTOCOLS] CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 5-1 SEARCH BOOK TOC GO BACK Operating Instructions Main Menu Screen Chapter 5 The MAIN MENU screen is divided into 4 sections. ! ! The upper left corner shows the current version of the instrument software. The Status Box is displayed in the top center of the screen in inverse video. This box appears on every screen to show the following: - ! Menu in use Analyzer status Other applicable information, such as report or file identity, and any existing fault conditions The upper right corner shows the current date, time, operator ID, and the sequence number. The information in the upper right corner is displayed on every screen during operation. The cursor is positioned at the <OPERATOR ID> field when the MAIN MENU is displayed. An operator ID of up to 3 digits may be entered. This operator ID will be displayed on all other screens and printed on all reports. Routine Operation The [RUN] key on the MAIN MENU is used to display the RUN MENU. The upper left corner of the RUN MENU screen displays the following fields: 5-2 1. <SPECIMEN ID#> 2. <TYPE:> used to display the specimen type selected. 3. <PRE-DILUTE> <PRE-DILUTE MODE> is displayed in inverse video when the <PRE-DILUTE> field is selected. used to enter the ID number for the next sample to be run. (Up to 9 characters may be entered.) Refer to the Sample Analysis section for more information about this feature. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 SEARCH BOOK TOC GO BACK Chapter 5 Operating Instructions The Status Box is displayed in the top center of the RUN MENU screen. It contains the following information: ! ! ! ! Menu in use Status of the analyzer – Ready – Not Ready – Standby – Initialized Fault messages Instructive messages (during the run cycle) such as the following: – Aspirating – Dispensing – Remove specimen – Counting – Recount – Rinsing The upper right corner of the RUN MENU screen displays the following information: ! ! ! Key Labels Current date and time Operator ID - Identification of the current operator Sequence # - Automatically incremented as samples are run The key labels displayed across the bottom of the RUN MENU screen are used to access the menu options that are available. The RUN MENU keys are listed below: [CLEAR ORIFICE] [PRE-DILUTE] [SPECIMEN TYPE] [PARAMETER SELECT] [PRINT TICKET] [PRINT] [HELP] [MAIN] Clear Orifice CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 [CLEAR ORIFICE] is used to initiate the aperture cleaning sequence that flushes the WBC and RBC/PLT apertures to remove obstructions. The sequence takes approximately 35 seconds. When [CLEAR ORIFICE] is pressed, the message <CLEARING ORIFICE> is displayed in the Status Box. 5-3 SEARCH BOOK TOC GO BACK Operating Instructions Chapter 5 Pre-Dilute [PRE-DILUTE] turns the pre-dilute mode run cycle ON and OFF. When ON, the <PRE-DILUTE> message appears in the upper right section of the screen. The specimen probe is raised and placed over the RBC/PLT dilution bath. This allows the operator to remove the upper front cover and pour a pre-diluted 1:251 sample into the initial dilution bath. The touch plate is then pressed to start the pre-dilute run cycle. Specimen Type [SPECIMEN TYPE] is used to select the type of specimen that will be run. When [SPECIMEN TYPE] is pressed, the following keys are available: [PATIENT SPECIMEN] [LOW CONTROL] [NORMAL CONTROL] [HIGH CONTROL] [NORMAL BACKGRND] [ELECTRICL BACKGRND] [HELP] [RUN] Patient Specimen [PATIENT SPECIMEN] is used to select the RUN MENU for running patient samples. Patient identification may be entered on the RUN MENU after this key is pressed. Results from this run option are stored in the Data Log. QC Control(s) The 3 QC control keys, [LOW CONTROL], [NORMAL CONTROL], and [HIGH CONTROL], are used to select one of the 3 control types. Data from these control runs are automatically stored in the designated QC file. Normal Backgrnd [NORMAL BACKGRND] is used to select a special run mode and to display the background results. Results from this run option are identified by the designation BACKGRD in the data log and are automatically excluded from the X-B analysis. 5-4 CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 SEARCH BOOK TOC GO BACK Chapter 5 Operating Instructions Electricl Backgrnd [ELECTRICL BACKGRND] is used to select the run mode for electrical background counts. Electrical backgrounds are used to check for electrical interference in the system. (Aperture current is turned OFF during this cycle.) Results from this run option are identified by the designation ELEC BKGD in the data log and are automatically excluded from the X-B analysis. Help [HELP] displays one or more screens of information that provide a brief explanation of the screen functions and keys. When additional information is available, the message <MORE> is displayed in the lower right corner. Press the Right Arrow key to access this information. Run Press [RUN] to return to the RUN MENU screen. Parameter Select [PARAMETER SELECT] allows the operator to choose the parameters to be displayed and printed. Print Ticket [PRINT TICKET] is used to print the current screen data on a ticket. It is used when the automatic ticket print feature is set to OFF. When there is no ticket in the printer, the message <TICKET> appears above the key labels. Print [PRINT] is selected to print the current screen data on the graphics printer. It is used when the automatic graphic print feature is set to OFF. When there is no paper in the printer, the message <PRINTER> appears above the key labels. Help [HELP] displays one or more screens of information that provide a brief explanation of the screen functions and keys. When additional information is available, the message <MORE> is displayed in the lower right corner. Press the Right Arrow key to access this information. Main Press [MAIN] to return to the MAIN MENU. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 5-5 SEARCH BOOK TOC GO BACK Operating Instructions Chapter 5 Setup System Operation The SETUP MENU is used to review and change options for data format to output devices such as printers and computers. The units of measure display and print format options are also selected from this screen. ON OFF The function is active. The function is not active. Any number displayed in place of ON or OFF can be changed using the numeric keys on the keypad to enter a new number within the stated limits. For example, the number preceding the "line-feeds per printer page" statement applies to the graphic printer and indicates the current line-feed selection. To Review or Change Setup Status 1. At the MAIN MENU, press [SETUP]. The SETUP MENU displays. Review and/or change any selection on the SETUP MENU screen. 2. ARE THE SELECTIONS ACCEPTABLE? YES Press [MAIN] to return to the MAIN MENU screen. NO Use the Arrow keys on the keypad to move the cursor to the selection requiring change. Press Enter to toggle between ON or OFF. OR Type the new number that is within the limits shown for the selection. Repeat this process until all required changes are complete. Go to the Date/Time Setup procedure. The SETUP MENU is also used to enter or review numeric data, such as date, time, patient specimen limits for alert, control lot number, target and limits values for control, replicate and X-B program files, etc. Refer to Chapter 2, Installation, for procedures. 5-6 CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 SEARCH BOOK TOC GO BACK Chapter 5 Operating Instructions Specimen Collection and Handling Specimen Stability Fresh whole blood specimens are recommended. The ICSH defines a fresh blood specimen as one processed within 4 hours after collection. Well-mixed whole blood specimens, collected in EDTA anticoagulant and run within 8 hours after collection, provide the most accurate results for all parameters. The white cells size distribution may shift when specimens are assayed between 5 and 20 minutes after collection or more than 8 hours after collection. The stability of capillary specimens collected in micro-collection devices may vary depending on the micro-collection device manufacturer. Refer to the manufacturer's package insert for stability claims. Specimen Collection NOTE Sample Analysis All samples should be collected using proper technique. For additional information on collecting venous and capillary samples, refer to NCCLS Standards, H3-A31 and H4-A32. An overview of sample analysis on the CELL-DYN 1600 is provided in Chapter 3, Principles of Operation. This section provides guidelines and instructions for the routine sample analysis. • • • CAUTION Operator ID Samples should not be run until the instrument has been initialized and daily QC checks have been performed. Samples may be analyzed whenever READY is displayed in the Status Box on the RUN MENU. Samples should be well mixed before they are run. If the System has been idle for 15 minutes or more, a normal background should be run immediately prior to running any patient specimens. The operator should enter an Operator ID before running samples. The Operator ID is displayed on all screens and printed on the graphics report and the ticket report. It is also retained in the QC logs and the Data Log. The Operator ID is entered from the MAIN MENU. When this screen is selected, the cursor is positioned in the <OPERATOR ID> entry field. Type up to 3 digits and press [ENTER] to save the ID number. CELL-DYN® 1600 Operator's Manual 9140214 Rev F—April 1996 5-7 SEARCH BOOK TOC GO BACK Operating Instructions Chapter 5 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 .] Alerts and Indicators NOTE 1. A sample ID number of up to 9 digits may be entered in the <NEXT ID> entry field. 2. An auto-increment feature automatically increases the sample ID number by 1 digit each time a sample is run. This section describes information displayed on the screen as the samples are analyzed and/or when reports are printed. This section does not discuss how to interpret parameter flags, which are displayed after the sample is run. Refer to Chapter 3, Principles of Operation, for detailed explanations of each flag. • • • NOTE A complete explanation of metering faults is given in the Operational Messages and Data/Parameter Flagging sections of Chapter 3, Principles of Operation. • NOTE 5-8 Results that fall outside the range of the limit set are displayed in inverse video. These results are underlined on the graphic printout. They are indicated by an asterisk on a pre-printed ticket. Results that exceed a parameter's linear range are indicated by >>>> in place of the result. If a WBC or RBC/PLT metering fault occurs, results are suppressed for the affected parameters and the appropriate<CLOG> or <FLOW ERROR> message is displayed. The upper metering and count times are also displayed. These messages and times are also printed in the graphics report. [CLEAR FAULT ]is displayed and a message (e.g.,<DILUENT EMPTY >) appears in the Status Box on the data module if a fault condition is detected. The Status Box displays the message<FAULT: SEE DIAG>or <SEE SPECIAL> to direct the operator to either the DIAGNOSTICS or the SPECIAL PROTOCOLS menu for further instructions. After the problem has been corrected, press [CLEAR FAULT ] to resume operation. CELL-DYN® 1600 Operator's Manual 9140214 Rev F—April 1996 SEARCH BOOK TOC GO BACK Chapter 5 Operating Instructions Instrument Start Up The CELL-DYN 1600 power switches should be left ON at all times. The instrument has been designed to automatically maintain itself when it is idle. If the instrument is idle for 4 hours, an automatic shutdown cycle is initiated. The instrument is placed in the STANDBY mode at the end of the automatic shutdown cycle. Power to the printer may be left ON or OFF at the operator's discretion. Refer to Chapter 11, Printers, for complete instructions for printer operation. A complete procedure for powering the system ON or OFF is given in Chapter 2, Installation. Daily Start Up Procedures The automatic Start Up cycle is designed to prime the flow system and check the background counts whenever STANDBY or INITIALIZED appear in the Status Box on the RUN MENU screen. Auto-startup is activated by pressing [RUN] on the MAIN MENU. Startup Procedure CAUTION 1. Be sure that READY is displayed in the Status Box. If the System has been idle for 15 minutes or more, a normal background should be run immediately prior to running any patient specimens. 2. If the Status Box on the RUN MENU screen displays STANDBY or INITIALIZED, press [RUN] to initiate the automatic start up cycle. 3. Perform the daily Quality Control checks asdirected in the following section. Daily Quality Control Checks Quality Control checks should be performed on a daily basis according to the laboratory's protocol. Commercial control materials should be properly warmed and mixed according to the manufacturer's recommendations. Patient controls should be handled according to the laboratory's protocol. CELL-DYN® 1600 Operator's Manual 9140214 Rev F—April 1996 1. From the RUN MENU screen, press [SPECIMEN TYPE]. 2. Select the key label for the type of specimen to be run:[PATIENT SPECIMEN], [LOW CONTROL ,] [NORMAL CONTROL ,] [HIGH CONTROL ], or one of the nine replicate files. The type currently selected is displayed in the upper left section of the screen. 3. Run the control following the “Running Samples” procedure presented on the next page. 5-9 SEARCH BOOK TOC GO BACK Operating Instructions 4. NOTE Running Samples Daily Shutdown 5-10 Chapter 5 Verify that the results are acceptable. Out of range control results are displayed in inverse video. 5. If the results are unacceptable, repeat the run. If the results are still unacceptable, obtain a new bottle of the control. Be sure that it is warmed and mixed properly and again repeat the run. If the results are still unacceptable, run the other levels of control material. If the results on all levels are unacceptable, troubleshoot accordingly. See Chapter 10, Troubleshooting. 6. When the control results are acceptable, patient samples can be analyzed. 1. Be sure that READY is displayed in the Status Box on the RUN MENU screen. 2. Open the sample tube. Place it under the sample aspiration probe so that the probe is immersed in the well-mixed sample. Consider all clinical specimens as potentially infectious. Use established, good laboratory working practice when handling these samples. 3. Press the touch plate located behind the probe to start the cycle. The Status Box on the RUN MENU displays messages to indicate the various stages of the cycle. 4. Remove the sample tube after the beepsounds. The probe moves up through the wash block for cleaning. 5. When the cycle is complete, the probe moves down into position for the next sample and the results are displayed on the screen. 6. If automatic report printing has been specified, a report is printed according to the parameters selected during Setup. 7. Repeat this procedure for subsequent samples. It is not necessary to perform a shutdown procedure daily as the instrument automatically goes into the STANDBY mode if it has been idle for 4 hours. If desired, the operator may place the instrument in the STANDBY mode by pressing [DAILY SHUTDOWN] on the second SPECIAL PROTOCOLS MENU screen. This causes the equipment to: 1. Rinse the flow system. 2. Set the timer control that periodically opens all of the solenoid valves to prevent pinched tubing. CELL-DYN® 1600 Operator's Manual 9140214 Rev F—April 1996 SEARCH BOOK TOC GO BACK Chapter 5 Operating Instructions Power Off Procedure Whenever power to the instrument is to be turned OFF, the operator must perform the same procedures described above in the automatic shutdown cycle. 1. Press [DAILY SHUTDOWN] on the second SPECIAL PROTOCOLS MENU screen. 2. When the cycle is complete, move the side panel power switch to OFF. 3. Remove the tubing from the lyse pump rotor to prevent pinching. 4. Follow the procedures described in Chapter 2, Installation, when the power is restored. Using the Data Log The Data Log stores all data in a log format for the last 320 cycles run on the instrument. The information is stored chronologically by sequence number. Data Log Menu When [DATA LOG] is pressed, the DATA LOG screen is displayed and the following keys are available: [FIND SEQ OR SPECIMEN ID] [EDIT SPECIMEN ID] [REJECT/ACCEPT SPECIMEN] [PRINT REPORT FOR 1 SPECIMEN] [TRANSMIT DATA] [PRINT DATA SUMMARY] [HELP] [MAIN] Find Seq or Specimen ID [FIND SEQ OR SPECIMEN ID] is used to find a specific sequence ID # or specimen ID # among those displayed on the DATA LOG screen. When [DATA LOG] is pressed, up to 16 of the latest specimen results are displayed on the DATA LOG screen. To display a specific sequence ID #, press [FIND SEQ ID]. The cursor moves to the <SEQUENCE #> field. Type the desired number and press [ENTER]. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 5-11 SEARCH BOOK TOC GO BACK Operating Instructions Edit Specimen ID Chapter 5 [EDIT SPECIMEN ID] is used to edit the Specimen ID # from the DATA LOG screen. When [EDIT ID] is pressed, the cursor moves to the <SPECIMEN ID> field and all key labels are blank. Edits are saved by pressing [ENTER]. Reject/Accept Specimen If the cursor is positioned at a sample identified with a B preceding the sequence number, the sample results are included (accepted) in the X-B analysis. ! ! To reject the sample results, press [REJECT/ACCEPT SPECIMEN]. The B is deleted and an R is displayed following the specimen ID. To accept the sample results, press [REJECT/ACCEPT SPECIMEN]. The R is deleted and a B is displayed preceding the specimen ID. Print Report for 1 Specimen [PRINT REPORT FOR 1 SPECIMEN] is used to print the results of the selected specimen indicated by the position of the cursor in patient report format or ticket format. NOTE No histogram data is stored or printed. When [PRINT REPORT FOR 1 SPECIMEN] is pressed, the following keys are available: [GRAPHICS PRINTER] [TICKET PRINTER] [HELP] [RETURN] Transmit Data NOTE Print Data Summary 5-12 [TRANSMIT DATA] is used to transmit a record to an on-line computer. When [TRANSMIT DATA] is pressed, the screen prompts the operator to enter the starting and ending sequence numbers (from the lowest to the highest) for the desired transmission. Records may be transmitted singly or in batches as designated by the sequence numbers. No histogram data is stored or printed. [PRINT DATA SUMMARY] performs the same task as [TRANSMIT DATA], only the data is printed on the graphics printer rather than transferred to an on-line computer. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 SEARCH BOOK TOC GO BACK Chapter 5 References Operating Instructions 1. NCCLS Standard H3-A3, Procedure for the Collection of Diagnostic Blood Specimens by Venipuncture—Third Edition; Approved Standard (1991). 2. NCCLS Standard H4-A3, Procedure for the Collection of Diagnostic Blood Specimens by Skin Puncture—Third Edition; Approved Standard (1991). CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 5-13 SEARCH BOOK TOC GO BACK Operating Instructions 5-14 Chapter 5 CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 SEARCH BOOK TOC GO BACK Chapter 6 Calibration Calibration Introduction The CELL-DYN® 1600 is calibrated at the factory just before shipment. An Abbott authorized Field Service Representative assists the operator in confirming the calibration during instrument installation. Calibration may be performed with commercial calibrator or fresh whole blood samples. Only the directly measured parameters WBC, RBC, HGB, MCV, PLT, and MPV may be calibrated. The instrument is electronically stable and should not require frequent recalibration when it is operated and maintained according to the recommendations in this manual. On-board quality control programs are designed to provide continual monitoring and verification of instrument calibration. The laboratory should make the decision to recalibrate based on the performance of the CELL-DYN 1600 in these quality control programs. The programs include statistical computations and Westgard Rules for commercial or patient controls and monitoring of patient samples for RBC parameters using Bull's moving average program (X-B). Calibration should be confirmed on a regular basis according to the requirements governing quality control in your laboratory. In keeping with good laboratory practices, this should include daily verification on each shift and following a reagent lot number change. Verification of calibration is also recommended following the replacement of any major instrument component that could affect calibration. Calibration may be verified by running appropriate commercial controls or by using fresh whole blood samples that were analyzed on a reliably calibrated hematology analyzer or by reference methodology. Calibration Guidelines General Information The CELL-DYN 1600 has 3 modes of operation: ! ! ! Open mode Closed mode Pre-dilute mode For convenience, the Open mode is calibrated first and the Closed mode and Pre-dilute mode are then referenced to it. There are several ways to accomplish the total calibration, depending only on the preference of the user. The following Calibration Procedural Guidelines section provides a quick reference guide to the remainder of the chapter. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 6-1 SEARCH BOOK TOC GO BACK Calibration Chapter 6 Calibration Procedural Guidelines There are several ways to accomplish total calibration of the system. They are: ! ! ! ! Auto-Cal — automatic calibration program incorporated in the software Factor Entry Calibration — an alternative to Auto-Cal Lyse Volume Dispense Calibration Latex Particle Calibration (MPV only) The instrument's Open mode is calibrated with the calibration material of choice, using the method of choice. The Closed mode is then referenced to match the Open mode with fresh whole blood samples (refer to the Addendum section of this manual for instructions). This chapter contains an overview of the calibration methods and gives a detailed explanation of how to perform each procedure. Review the Pre-Calibration Guidelines section before beginning the selected calibration procedure. The calibration procedures have been divided into subsections that consist of a series of easy-to-follow steps. Always follow the entire procedure unless specifically directed to skip to another section. For manual calibration, worksheets may be used to assist in making the necessary calculations. These worksheets may be duplicated as needed. Calibration Materials CAUTION Consider all clinical specimens and controls, calibrators, etc. that contain human blood or serum as potentially infectious. Use established, good laboratory working practices when handling these samples. Wear gloves, lab coats and safety glasses and follow other biosafety practices as specified in the OSHA Bloodborne Pathogen Rule or other equivalent biosafety procedures. 3 calibration materials can be used to calibrate the CELL-DYN 1600: ! 6-2 CELL-DYN calibrator A calibrator is the preferred material for calibrating the CELL-DYN 1600. It is most efficiently performed by calibrating the Open mode using the Auto-Cal method. The Closed mode is then referenced to match the Open mode using fresh whole blood samples. NOTE The term “calibrator” refers to a commercial reference material—either calibrator or control. According to the Food and Drug Administration (FDA), when a control is used as a calibrator, a different lot or brand of control must be used for daily quality control. NOTE Never use a hemoglobin standard that is designed specifically for use with cyanmethemoglobin reagents. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 SEARCH BOOK TOC GO BACK Chapter 6 Calibration ! ! Latex Particles Latex particles are used to calibrate the Mean Platelet Volume. This calibration is verified by an Abbott authorized representative during installation of the instrument. Fresh Whole Blood Calibration with fresh whole blood is accomplished by performing multiple analyses of each sample by acceptable reference methodology and calculating the mean reference value for each parameter. The same samples are analyzed on the CELL-DYN 1600 in the Open mode. The Closed mode is then referenced to match the Open mode using another set of fresh whole blood samples. A detailed discussion of Whole Blood Calibration is given in the next section. Whole Blood Calibration Guidelines Introduction Calibration with fresh whole blood samples is an alternative to calibration with a commercial calibrator. This section explains the determination of reference values and gives requirements for whole blood samples. Sample Requirements for Fresh Whole Blood The following requirements should be observed for fresh whole blood samples used for calibration: ! ! The ICSH recommends that fresh samples be less than 4 hours old. Sample age must not exceed 8 hours at the conclusion of the calibration procedure. All parameter values should be within the laboratory's normal range. The following ranges are programmed for the reference values that may be entered in the Auto-Cal program. Results exceeding these limits cannot be entered. WBC RBC HGB MCV HCT PLT CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 5.0 3.50 10.0 80 30.0 150 — — — — — — 12.0 5.50 24.0 100 50.0 400 6-3 SEARCH BOOK TOC GO BACK Calibration NOTE Chapter 6 Obtain a reference RBC and HCT value for each calibration specimen. When the RBC and HCT values are entered, a reference MCV is automatically calculated. ! ! ! ! All cellular morphology must be normal. No known interfering substances should be present (e.g., lipemia, icterus, drugs). All samples must be properly collected in the EDTA anticoagulant used by the laboratory. Each tube should contain at least 90% of the nominal collection volume of blood. Determination of the Reference Values Reference values for Whole Blood Calibration should be determined according to the following ICSH recommendations. WBC, RBC, and PLT Reference values may be determined using multiple counts from a certified hemocytometer or from a reliably calibrated hematology analyzer. Hemoglobin NOTE MCV DO NOT attempt to calibrate the CELL-DYN 1600 with a hemoglobin standard designed for the calibration of specific reference cyanmethemoglobin methods. The instrument uses a modified hemiglobincyanide method which is not designed to analyze these standards directly. Reference values may be determined by calculation from the reference microhematocrit and RBC measurements or from multiple analyses on a reliably calibrated hematology analyzer. NOTE 6-4 Reference values may be determined using either the reference cyanmethemoglobin method or a reliably calibrated hemoglobinometer or hematology analyzer. Reference microhematocrit values may be determined by multiple analyses using the NCCLS method for Packed Cell Volume (PCV). Use only plain (non-anticoagulated) capillary tubes. Be certain to verify the proper operation of the microhematocrit centrifuge and the timer as recommended by NCCLS. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 SEARCH BOOK TOC GO BACK Chapter 6 Calibration Calibration Requirements for Fresh Whole Blood Minimum requirements for Whole Blood Calibration are described in the following list. Additional samples and/or more replications of the samples may be used. ! ! ! ! ! NOTE CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 A minimum of 5 samples is required for adequate Whole Blood Calibration. Samples must be assayed at least in triplicate by reference methodology and on the CELL-DYN 1600. No more than 2 hours should elapse between the CELL-DYN 1600 run and the assay by reference methodology. If samples are run on the CELL-DYN 1600 first, assay by reference methodology should be completed within 1 hour. (Certain reference methodologies are sensitive to RBC swelling caused by in vitro deoxygenation.) Mean values should be calculated for each parameter for each sample from the reference assay results. These mean parameter values can then be entered in the Auto-Cal program as reference values for each sample. If Auto-Cal is not being used, the mean parameter values should be averaged to obtain the cumulative mean value for each parameter. A worksheet is provided on the following page. This worksheet may be used to assist with the calculation of the reference means and may be duplicated as needed. 6-5 SEARCH BOOK TOC GO BACK Calibration Chapter 6 Whole Blood Calibration Reference Values Worksheet Date:__________________________________ Parameter: _____________________________ Technologists: __________________________ Method: _______________________________ Sample ID Reference Assays 1 2 3 4 5 6 Mean 7 8 9 10 Cumulative Parameter Mean 6-6 CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 SEARCH BOOK TOC GO BACK Chapter 6 Calibration Pre-Calibration Procedures It is advisable to perform calibration at a time when it can be completed without interruption. The Pre-Calibration Procedures in this section verify proper instrument performance to ensure a successful calibration. These steps must be completed just before beginning calibration. If problems are detected during these checks, DO NOT ATTEMPT TO CALIBRATE THE INSTRUMENT. If necessary, call the Customer Support Center for assistance. After the problems have been resolved, repeat the precalibration procedures to verify proper performance. Review the following guidelines before beginning any calibration procedure. • • • • • • • • CAUTION Use specimens that have NO known interfering substances. Use specimens that are at room temperature and mixed properly. Use only the recommended CELL-DYN reagents -- other brands are unacceptable. (See Chapter 7, Quality Control.) Confirm that reagent containers are at least half full -- replace them as necessary. Prior to calibration, instrument precision should be verified within stated Absolute Limits. (See Chapter 4, Table 4.5) Always perform the Daily, Weekly, and Monthly scheduled maintenance as directed in Chapter 9, Maintenance, before calibrating the instrument. Instrument cleanliness is essential for accurate calibration. Therefore, each laboratory should perform any additional maintenance according to its requirements. Confirm that Normal Background is within limits. Confirm that the operator ID number is entered. If the System has been idle for 15 minutes or more, a normal background should be run immediately prior to running any calibration specimens. Calibration Logbook Abbott suggests that you create a logbook for the instrument. This logbook should contain all necessary calibration documentation and other information that is pertinent to your instrument. Suggested sections that you may want to include in the logbook are: • • • • • • • • Laboratory operating procedures Quality Control Calibration Maintenance Troubleshooting Problem resolution Service calls Installation documentation This logbook should be stored near the instrument and be accessible to all operators and Abbott Service Personnel. Calibration Menu Screen CELL-DYN® 1600 Operator's Manual 9140214 Rev F—April 1996 6-7 SEARCH BOOK TOC GO BACK Calibration Chapter 6 The CALIBRATION MENU screen is accessed from the MAIN MENU screen by pressing [CALIBRATION]. [CALIBRATION] The CALIBRATION MENU screen is explained in this section. This section will introduce the keys displayed after the Calibration mode is selected. The function of each key that appears on the CALIBRATION MENU screen is explained in this section. Enter Factor [ENTER FACTOR]is used to enable the operator to enter calibration factors directly (Factor Entry Method). Pre-dilute [PRE-DILUTE] is used to toggle between selecting and deselecting the pre-dilute mode and to load corresponding calibration factors for review and possible change. Auto-Cal Select [AUTO CAL SELECT]is used to display the screen labels for the calibrator, fresh whole blood, and latex particles calibration methods. Calibrator [CALIBRATOR] initiates calibration using a calibrator. Fresh Blood [FRESH BLOOD] initiates calibration using fresh blood specimens. Latex Particles [LATEX PARTICLES] initiates calibration of MPV using latex particles. Lyse Volume [LYSE VOLUME] selects the menu for lyse volume procedures. Print [PRINT] is used to print a report of the current calibration factors. Return [RETURN] returns the display to the main calibration screen. Auto-Cal Method Introduction 6-8 This method allows the operator to enter reference assay values and run either whole blood or calibrator with CELL-DYN 1600 reference values. The computer utilizes the entered results from a minimum of 3 runs to calculate a factor for each specimen. A CELL-DYN® 1600 Operator's Manual 9140214 Rev F—April 1996 SEARCH BOOK TOC GO BACK Chapter 6 Calibration Auto-Cal Method Introduction This method allows the operator to enter reference assay values and run either whole blood or calibrator with CELL-DYN 1600 reference values. The computer utilizes the entered results from a minimum of 3 runs to calculate a factor for each specimen. A mean factor is calculated for all specimens run. Procedure 1. Obtain the appropriate calibration materials, either calibrator or fresh whole blood. ! ! NOTE CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 If a calibrator is used: — Ensure that commercial calibrator vials are brought to room temperature and mixed according to the manufacturer's instructions given in the package insert. — Ensure that the calibrator's expiration date has not been reached. If fresh whole blood is to be used, follow the guidelines provided in this chapter relating to the selection and use of fresh whole blood samples. 2. At the MAIN MENU screen, press [CALIBRATION]. 3. Press [AUTO CAL SELECT]. 4. Press the appropriate key for the calibration method you are using, either [FRESH BLOOD] or [CALIBRATOR]. 5. Set the cursor to the parameter to be calibrated. 6. Press [ENTER]. The screen changes to reflect your updates. 7. Enter the parameter's reference assay value for the calibration specimen to be run (RBC calibration requires 3 digits). The cursor automatically advances to the next selection. When MCV is selected, the message <REFERENCE VALUE FOR MCV MAY BE SUPPLIED BY ENTERING VALUES FOR RBC AND HCT. TO DO SO, PRESS # AND ENTER VALUES WHEN PROMPTED.> appears in the lower screen. When [#] is pressed, MCV changes to RBC, allowing the operator to enter the red cells reference value (using 3 digits). Then <HCT> appears allowing the operator to enter the hematocrit reference value. The computer calculated MCV reference value must be within the normal range of 80 to 100 to be accepted and displayed. 8. Repeat steps 4 through 6 until all parameters to be calibrated with the calibration specimen are selected and the corresponding reference values are entered. 9. Mix the specimen well by inverting it at least 10 times. Do not shake the specimen. 6-9 SEARCH BOOK TOC GO BACK Calibration NOTE WARNING Chapter 6 10. When <READY> appears, place the well-mixed specimen under the aspirating probe and press the Touch Plate to actuate the auto-calibration cycle. The analyzer performs RUN 1 measurement and displays the values in the RUN 1 column. 11. When the cycle is complete, repeat step 10 twice — once for RUN 2 measurement and once for RUN 3 measurement. When the value for any run exceeds the computer acceptance criteria, the value is highlighted indicating the measurement cycle must be repeated. Should this situation occur repeatedly, press [ABANDON] to stop the auto-calibration process for this specimen without deleting the mean factor for specimens already run. If necessary, obtain technical assistance or see Chapter 10, Troubleshooting, for corrective action. 12. When results for the 3 runs are acceptable, the calibration factor is calculated using the accepted run data for each parameter selected in steps 4 and 7. The screen displays the calculated factor and mean factor for each parameter indicating the auto-calibration cycle for this specimen is complete. 13. Repeat steps 4 through 11 for each calibration specimen. Do not press [RESET FACTORS] between specimens. This key is used to delete the mean factor for all specimens run prior to pressing the key. 14. After all calibration factors are run, press [RETURN]. The main calibration screen appears. The calibration factors are saved at this point. 15. Press [PRINT] to print the new calibration factors. 16. Press [MAIN] to return to the MAIN MENU screen. 17. Press [RUN] to return to the RUN screen. 18. Run one of the following: ! ! 19. Confirm that the results obtained for each specimen: ! ! NOTE 6-10 3 additional specimens with reference assay values 3 levels of controls agree with the reference value within 2SD OR are within control limits. If the results for any parameter are consistently out, repeat calibration or obtain technical assistance. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 SEARCH BOOK TOC GO BACK Chapter 6 Calibration Factor Entry Method Introduction Enter factor key calibration is used to reset calibration to the factory calibration setting of 1.00. It can also be used to enter a pre-determined factor to adjust calibration when a consistent bias exists between CELL-DYN 1600 and a comparison analyzer or reference method. A percent bias factor can be determined and entered to change calibration within ± 20% for any of the directly measured parameters — WBC, RBC, HGB, MCV, PLT, MPV. Procedure 1. Run in triplicate, multiple (minimum of 3) specimens via comparison analyzer or method. 2. Calculate a cumulative reference mean (REF) for all specimens and runs for each parameter. For example: The reference WBC mean is 6.6 when all of the following are true: ! specimen 1 RUN 1 = 6.8, RUN 2 = 6.9, RUN 3 = 6.8 ! specimen 2 RUN 1 = 9.2, RUN 2 = 9.0, RUN 3 = 9.2 ! specimen 3 RUN 1 = 3.9, RUN 2 = 4.0, RUN 3 = 4.0. 3. Run in triplicate the same specimens run in step 1 via CELL-DYN 1600 with an empty replicate file selected. Run all specimens in the same replicate file to obtain a cumulative CELL-DYN (CD) mean for all specimens and runs. 4. Press [MAIN]. 5. Press [QC] and select the appropriate replicate file. 6. Press [PRINT] to print the summary report for the selected replicate file to obtain a cumulative CD mean for each parameter. 7. Divide the reference mean from step 2 by the CELL-DYN 1600 mean printed in step 6 (REF divided by CD = calibration factor). For example: ! ! CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 When REF is 6.6 and CD WBC is 7.2, the calibration factor is 0.92 (6.6 divided by 7.2 = 0.917) When REF is 6.6 and CD WBC is 5.9, the calibration factor is 1.12 (6.6 divided by 5.9 = 1.119). 8. At the MAIN MENU screen, press [CALIBRATION]. A new screen and new labels appear. 9. Press [ENTER FACTOR]. A new screen and new labels appear. 10. Set the cursor to the parameter requiring the calibration factor change and type the new factor using 3 digits. To reset the number to the current factory setting, type [1] [0] [0]. 6-11 SEARCH BOOK TOC GO BACK Calibration Chapter 6 11. Repeat the previous step (step 10) as required to enter a new factor for each parameter. 12. Press [RETURN] to return to the main calibration screen. As required, press [PRINT] to print the current calibration status. 13. Press [MAIN]. 14. Press [RUN] to return to the RUN screen. 15. Run one of the following: ! ! 16. Verify that the results obtained for each specimen: ! ! NOTE 6-12 3 additional specimens with reference assay values 3 level controls. agree with the reference value within 2SD OR are within control limits. When results for any parameter are consistently out, repeat calibration for that parameter or obtain technical assistance. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 SEARCH BOOK TOC GO BACK Chapter 6 Calibration Pre-Dilute Method Introduction The pre-dilute calibration mode allows the operator to calibrate the CELL-DYN 1600 to adjust for any differences due to dilution when this special mode is selected. The pre-dilute calibration procedure and specimens are similar to the whole blood or calibrator method given earlier in this chapter. However, for pre-dilute calibration each calibration specimen is pre-diluted in the same manner as unknown patient specimens using CELL-DYN micropipettes 40uL end-to-end (30mm) with EDTA and 10mL of diluent that is dispensed using [10ml. DISPENSE] from the SPECIAL PROTOCOLS screen. Procedure 1. Obtain either a calibrator with CELL-DYN 1600 calibration reference values or one or more calibration specimens that meet the guidelines for each parameter. 2. Press [SPECIAL PROTOCOLS] to go to the SPECIAL PROTOCOLS screen. 3. Press [MORE] twice. 4. Press [10ml. DISPENSE] to activate the dispense mode. 5. Place an unused sample vial under the sample aspiration probe and press [10ml. PRE-DILUTE]. 10mL of diluent dispenses into the sample vial. 6. Repeat this process to obtain a minimum of three vials of diluent for each specimen to be run for calibration. 7. Press [MAIN] to return to the MAIN MENU screen. 8. Press [CALIBRATION]. 9. Press [PRE-DILUTE]. Select the calibration method. 10. Set the cursor to the parameter to be calibrated. 11. Press [ENTER]. The screen changes. 12. Enter the parameter's reference assay value for the calibration specimen to be run (e.g. <4> <8> <9> for RBC). The reference assay value always requires 3 digits. The cursor automatically advances to the next selection. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 6-13 SEARCH BOOK TOC GO BACK Calibration NOTE Chapter 6 When MCV is selected, the following message appears in the lower screen: <THE REFERENCE VALUE FOR MCV MAY BE SUPPLIED BY ENTERING VALUES FOR RBC AND HCT. TO DO SO, PRESS # AND ENTER VALUES WHEN PROMPTED.> When [#] is pressed, MCV changes to RBC, allowing the operator to enter the red cells reference value (using 3 digits). <HCT> appears allowing the operator to enter the hematocrit reference value. The computer calculated MCV reference value must be within the normal range of 80 to 100 to be accepted and displayed. 13. Repeat steps 10 through 12 until all parameters to be calibrated with this calibration specimen are selected and the corresponding reference values are entered. 14. Grasp the lower edge of the Upper Front Cover and pull it towards you (out) about 1 inch. Raise it up until it releases from the upper mount brackets. Set the cover aside or on top of the analyzer. (See Figure 6-1.) WARNING To prevent aspirating probe damage, always confirm the probe is raised before attempting to remove the upper front cover. NOTE The grounding wire may be detached to completely remove the Upper Front Cover. Figure 6-1 Removing the Front Cover 6-14 15. Mix the calibration specimen well by inverting it at least 10 times. Do not shake the specimen. 16. Completely fill a CELL-DYN micropipette with well-mixed calibration specimen. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 SEARCH BOOK TOC GO BACK Chapter 6 Calibration 17. Wipe the outside of the pipette with a lint-free gauze slightly dampened with diluent to remove excess blood. DO NOT REMOVE THE BLOOD FROM INSIDE THE PIPETTE. 18. Drop a filled pipette immediately into a vial containing 10mL of diluent. (This vial was prepared in step 5.) 19. Close the vial at the upper crease and invert a minimum of 15 to 20 times to thoroughly mix the blood and diluent (see figure 6-2). Figure 6-2 Vial Closure for Mixing NOTE The internal bore size of the CELL-DYN micropipette is designed to allow rapid mixing of blood and diluent. This initial 1:250 dilution is stable for 20 minutes and must be thoroughly remixed by inversion before pouring it into the initial dilution bath when the pre-dilute mode is selected. 20. CAUTION NOTE Do not allow the micropipette to fall into the dilution bath. 21. Press the touch plate to actuate the pre-dilute auto-calibration cycle. This performs the RUN 1 measurement and displays value(s) in the RUN 1 column. 22. When the cycle is complete, repeat steps 15 through 21 twice — once for RUN 2 measurement and once for RUN 3 measurement. When the value for any run exceeds the computer acceptance criteria, the value is highlighted indicating the measurement cycle must be repeated. Should this situation occur repeatedly, press [ABANDON] to stop the auto-calibration process for this specimen without deleting the mean factor for specimens already run. See Chapter 10, Troubleshooting, or obtain technical assistance. 23. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 Open the vial and carefully pour the diluted specimen into the initial dilution bath. When results for 3 runs are acceptable, the calibration factor for each parameter selected in steps 10 and 12 is calculated using accepted run data. The screen displays the factor and mean factor for each parameter indicating the auto-calibration cycle for this specimen is complete. 6-15 SEARCH BOOK TOC GO BACK Calibration NOTE Chapter 6 Do not press [RESET FACTORS] between specimens. This key is used to delete the mean factor for all specimens run prior to pressing the key. 24. Repeat steps 12 through 22 for each calibration specimen. 25. When all calibration specimens are run, press [RETURN]. The calibration factors are now saved. The main calibration screen appears. 26. Press [PRINT] to print the new calibration factors. 27. Press [MAIN]. 28. Press [RUN] to return to the RUN screen. 29. Press [PRE-DILUTE] to select the pre-dilute mode. 30. Run one of the following: ! ! 31. Confirm that the results obtained for each specimen: ! ! NOTE 3 additional specimens with reference assay values 3 levels of controls via the pre-dilute method. agree with the reference value within 2SD OR are within control limits. If results for any parameter are consistently out, repeat the calibration or obtain technical assistance. Latex Particles Method Introduction Calibration is required when mean platelet volume (MPV) values for QC specimens indicate that MPV is out-of-calibration. This procedure enables the operator to calibrate MPV utilizing latex particles. To date there is no acceptable reference method established for determination of a reference MPV. MPV calibration requires latex particles, and must be calibrated using this method. Guidelines for Calibration Review the following guidelines before beginning this calibration procedure. ! ! 6-16 Use only the required latex particle and reagents. Other brands are unacceptable. Resuspend latex particles according to the directions provided in the package insert. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 SEARCH BOOK TOC GO BACK Chapter 6 Procedure NOTE NOTE Calibration 1. Obtain latex particles and mix them according to the directions provided in the package insert to completely resuspend them. Aggregates will cause invalid calibration for MPV. 2. At the MAIN MENU screen, press [CALIBRATION]. 3. Press [LATEX PARTICLES]. A new screen appears. 4. Set the cursor to MPV and press [ENTER]. The screen changes. 5. Enter the reference assay value for latex particles to be run (using 3 digits). 6. Mix the calibration specimen well by inverting it at least 10 times. Do not shake the specimen. 7. When <READY> appears, place the well-mixed calibration specimen under the aspiration probe. Press the Touch Plate to actuate the auto-calibration cycle. This performs the RUN 1 measurement and displays values in the RUN 1 column. 8. When the cycle is complete, repeat step 7 twice — once for RUN 2 measurement and once for RUN 3 measurement. When the result for any run exceeds the computer acceptance criteria, the result is highlighted indicating the measurement cycle must be repeated. Should this situation occur repeatedly, consult Chapter 10, Troubleshooting, or obtain technical assistance. 9. When results for 3 runs are acceptable, the calibration factor is calculated using the accepted run data. The calculated factor and mean factor display indicating the auto-calibration cycle is complete. 10. Press [RETURN]. The main calibration screen appears. 11. Press [PRINT] to print the new calibration factors. 12. Press [MAIN] to return to the MAIN MENU. 13. Press [RUN] to return to the RUN screen. 14. Run one of the following: ! ! CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 3 additional specimens with reference assay values 3 levels of controls. 6-17 SEARCH BOOK TOC GO BACK Calibration Chapter 6 15. Confirm that the results obtained for each specimen: ! ! NOTE agree with the reference value within 2SD OR are within control limits. If results for any parameter are consistently out, repeat calibration or obtain technical assistance. Lyse Volume Dispense Calibration The volume of lyse dispensed is factory set. The amount of lytic reagent dispensed affects the diff-screen results and can vary slightly as a result of tubing and rotor wear during routine use. When lytic action is too little (increased alerts and size data shifted to the right), the amount of lyse dispensed can be increased. When lytic action is too great (increased alerts and size data shifted to the left), the amount of lyse dispensed can be decreased. Verification of the volume of lyse dispensed per cycle is required when the lyse tube under the pump rotor is replaced. It should be reset as needed to maintain diff-screen result accuracy. For special applications or research, the amount of lytic reagent dispensed is adjustable within the allowable range of 0.75 or 1.25mL. NOTE The volume of lyse dispensed is set by the factory at approximately 1.1 mL. Verification of lyse volume dispensed is done using a new screen and labels that appear when [LYSE VOLUME] is pressed. A 25mL graduated cylinder is required for this procedure. Procedure 6-18 1. At the MAIN MENU screen, press [SPECIAL PROTOCOLS]. 2. Press [MORE] until [10ml. DISPENSE] appears. 3. Place a 25mL graduated cylinder under the aspiration probe and press [10ml. DISPENSE] twice to actuate the dispense. 4. Repeat step 3 to dispense an additional 10mL of diluent. Determine in milliliters the exact amount of diluent in the cylinder. 5. Press [MAIN]. 6. Press [CALIBRATION]. 7. Press [LYSE VOLUME]. A new screen appears. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 SEARCH BOOK TOC GO BACK Chapter 6 NOTE NOTE Calibration 8. Remove the lyse inlet tubing from the lyse container and place it into the 25mL graduated cylinder. Make sure the end of the tubing touches the bottom of the cylinder. 9. Press [MEASURE VOLUME] to activate 10 consecutive lyse dispense cycles. This is a default cycle and disregards any entered volume. 10. When the lyse pump action stops, remove the lyse inlet tubing and measure the amount of the diluent aspirated. For an accurate measurement, the lyse tubing must be removed. Default dispense volume: The measured volume of diluent in milliliters from step 3 minus the measured volume of diluent remaining in the cylinder equals the volume of lyse dispensed during 10 cycles. 11. Enter the default dispense volume in milliliters using the keyboard numeric keys (9.0 to 11.0). 12. Press [SET VOLUME]. The current set volume appears with the set volume statement. 13. Type the new volume for lyse dispense in milliliters using the keyboard numeric keys (0.75mL to 1.25mL). The new volume is the number obtained in step 10 divided by 10. 14. NOTE Press [ENTER]. When no entry is made, no screen labels appear. Press [ENTER] to continue. 15. Repeat steps 1 through 3 to add additional diluent to the cylinder. 16. Place the end of the lyse tubing into a 25mL graduated cylinder. Confirm the end of the tubing touches the bottom of the cylinder. 17. Press [MAIN] to return to the MAIN MENU screen. 18. Press [CALIBRATION]. 19. Press [LYSE VOLUME]. 20. Press [VERIFY VOLUME]. When the lyse pump action stops, remove the lyse inlet tubing and measure the amount of diluent aspirated. This number should equal the new volume entered in step 13 multiplied by 10 ± 0.2mL. NOTE CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 If the two volumes do not agree, repeat this entire procedure or obtain technical 6-19 SEARCH BOOK TOC GO BACK Calibration Chapter 6 assistance. 21. Remove the lyse inlet tubing from the cylinder. 22. Press [VERIFY VOLUME]. Air circulates through the tube. 23. Place the lyse inlet tubing in the container of lyse. 24. Press [VERIFY VOLUME] again to refill the lyse inlet tubing with lyse reagent. 25. Press [MAIN]. The MAIN MENU screen appears. 26. Press [RUN]. The RUN screen appears. 27. Run one of the following: ! ! 28. Verify that the results obtained for each specimen: ! ! NOTE 6-20 3 to 5 specimens with WBC and/or HGB reference assay values 3 levels of controls. agree with reference value with 2SD OR are within control limits. When results for either parameter are consistently out, repeat calibration for that parameter or obtain technical assistance. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 SEARCH BOOK TOC GO BACK Chapter 7 Quality Control Quality Control Introduction The CELL-DYN® 1600 offers several Quality Control (QC) options to monitor and validate instrument performance. The options are: Commercial Controls — Numeric data obtained for each parameter are automatically transmitted to a designated file (low control, normal control, or high control) when that control file is selected. Replicate Specimen — This option works the same as the Commercial Controls program. The Replicate Specimen QC Program is non-specific for specimen type. Therefore, it can be used for previously run specimens, additional (overlapping) commercial control material, precision specimens, etc. X-B Analysis — This QC option is useful for troubleshooting and confirming the calibration of the red cells parameters. Quality Control Log This section discusses the options available when [QC] is pressed at the MAIN MENU. The options used to set up the QC files are available by pressing [SET UP] at the MAIN MENU. Refer to the Keypad Setups section of Chapter 2, Installation, for details regarding setting up the Control Files, Replicate Files, and X-B Files. The QC LOG screen allows the operator to perform the following functions: C C C X-B File Select 1 of 12 QC files Review, edit, or print stored data for each file including — lot number and expiration date or identification number — acceptable upper and lower range — results for all parameters up to 30 runs — mean — standard deviation — coefficient of variation Review or print the Levey-Jennings plots, including multi-rule (modified Westgard) alerts, as applicable This key initiates the display of the X-B DISPLAY screen and new labels allowing the operator to review or print a composite report, including the batch mean for each X-B parameter — MCV, MCH, and MCHC — calculated for the last 20 batches. Each stored batch mean is plotted. CELL-DYN® 1600 Operator's Manual 9140214 Rev E—February 1994 7-1 SEARCH BOOK TOC GO BACK Quality Control Chapter 7 Low Control, Normal Control, High Control The control keys initiate the display of the appropriate CONTROL FILES screen and new labels allowing the operator to: • • • • view the control data and statistical information manage the control file print or transmit the control file select Levey-Jennings to view the Levey-Jennings plot The keys available from the CONTROL FILES screen are described below. Purge This function permanently erases data from the control file. After [PURGE] is pressed, the screen label changes to [RESTORE]. Press [RESTORE] to cancel the purge. Press [RETURN] to complete the purge. NOTE Once [RETURN] is pressed, data in the file is permanently erased. [RESTORE] will not cancel a purge. Plot Levey-Jennings This function plots the data using the Levey-Jennings method and calls the LEVEYJENNINGS MENU. Reject/Accept Specimen When [REJECT] is selected, it removes a specimen from the statistical calculations; when [ACCEPT] is selected, it restores a specimen that was removed. Delete Specimen This function deletes a specimen from the control file. After [DELETE SPECIMEN] is pressed, the screen labels change to [DELETE SPECIMEN] or [RESTORE SPECIMEN]. Press [DELETE SPECIMEN] to complete the delete; press [RESTORE SPECIMEN] to cancel the delete. Transmit Data This function transmits the control file to an external computer. 7-2 CELL-DYN® 1600 Operator's Manual 9140214 Rev E—February 1994 SEARCH BOOK TOC GO BACK Chapter 7 Quality Control Print Data This function prints the control file data on the graphics printer. Replicate 1 through 9 This key initiates a new screen and new labels allowing the operator to access the desired replicate file and display the data. The keys available from the REPLICATE 1 through 9 MENU are described below. Purge REPL ––> CONT This function purges data from the file or copies it into a control file. To copy the replicate file to a control file, print a copy of each control file (low, normal, and high). Purge each control file, because the control file must be empty in order to transfer a replicate file to a control file. Press the key corresponding to the desired control file ([COPY LOW], [COPY NORMAL], [COPY HIGH]). Press [RETURN] to exit the copy function. Plot Levey-Jennings This function displays the Levey-Jennings plots. Reject/Accept Specimen When [REJECT] is selected, it removes a specimen from the statistical calculations; when [ACCEPT] is selected, it restores a specimen that was removed. Delete Specimen This function deletes a specimen from the control file. After [DELETE SPECIMEN] is pressed, the screen labels change to [DELETE SPECIMEN] or [RESTORE SPECIMEN]. Press [DELETE SPECIMEN] to complete the delete; press [RESTORE SPECIMEN] to cancel the delete. Transmit Data This function transmits the control file to an external computer. CELL-DYN® 1600 Operator's Manual 9140214 Rev E—February 1994 7-3 SEARCH BOOK TOC GO BACK Quality Control Chapter 7 Print Data This function prints the control file data on the graphics printer. Quality Control Guide General Information The first section of the guide gives information about running controls and guidelines for basic assay verification. The section on Westgard Rules defines the rules used and gives guidance for their application in the hematology laboratory. The commercial controls, replicate specimen, and X-B analysis programs are discussed in detail in the last section. All QC data should be reviewed according to your laboratory's protocol. Refer to the appropriate sections in this chapter for suggestions and guidelines for interpreting the results. Running Controls Control Material Abbott recommends using the CELL-DYN control materials for performing quality control checks on the CELL-DYN 1600. These controls should be run: • • • • • • after calibration (confirmatory step) after Daily Start-up procedures are completed after a reagent lot number change after maintenance, a service call, or component replacement in accordance with the laboratory's quality control protocol according to regulatory requirements The controls may be run in either open mode or CS mode. NOTE A procedure for using patient samples to verify closed mode performance is given in the Closed Sample Aspiration Module section of this manual. To ensure accuracy of the results when commercial control specimens are run: • • • 7-4 Verify the control's condition when it is received. Confirm that vials are cold and not leaking. Check for hemolysis. Always resuspend according to the control manufacturer's recommendations. Never use an open vial longer than is recommended by the manufacturer. CELL-DYN® 1600 Operator's Manual 9140214 Rev E—February 1994 SEARCH BOOK TOC GO BACK Chapter 7 Quality Control $ $ CAUTION Verify values for the new lot of control by running each level as described in the "Assay Verification" section, along with either replicate QC specimens or the old control when it is still in date. When results for any parameter(s) are flagged (outside of entered limits), reconfirm calibration for that parameter using specimens with known reference values. When calibration verification results are acceptable, either establish a new working mean and limits for each level of the new lot of control or call the Abbott Customer Support Center. If the System has been idle for 15 minutes or more, a normal background should be run immediately prior to running any control specimens. Mixing and Handling Always mix and handle commercial control materials according to the directions given in the package insert. As the directions may vary from manufacturer to manufacturer, pay particular attention to the following: $ $ $ Assay Verification Store the controls at recommended temperatures. Storage in a central location in the refrigerator, away from the door if it is opened frequently, is advisable. Carefully warm and resuspend the product according to the directions given in the package insert. Proper mixing is essential for accurate results. Check the open-vial stability dating and do not use products longer than is recommended or results may be compromised. New lots of control material should be analyzed in parallel with current lots prior to their expiration dates. This may be accomplished by running the new lot of controls twice a day for five days using any empty replicate files. The replicate files calculate the mean, standard deviation and coefficient of variation for each stored parameter. The instrument-calculated means of these ten runs should be within the expected ranges published by the manufacturer. Replicate files may be set up for the new lot number to easily establish the mean values. However, the replicate files store only the absolute values for the three-part differential. If you wish to validate the differential percents (LYM, MID, GRAN), refer to the instructions given in the next section. The expected ranges published by manufacturers are generally too broad for effective quality control.1 Therefore, your laboratory's established means and SDs for the new controls lots should be edited into the appropriate Quality Control file when new lots are placed into daily use. As a result, these ranges will now be used by the system to automatically monitor all parameters for each control run. These ranges may be determined by evaluating three to six months of data (data from the Interlaboratory QC Program may be used) for a particular level of control. CELL-DYN® 1600 Operator's Manual 9140214 Rev FCApril 1996 7-5 SEARCH BOOK TOC GO BACK Quality Control Chapter 7 The individual SD values may be averaged as follows: 2 2 2 (N1 × SD1 )%(N2 × SD2 )%...(Ni × SDi ) Average SD = (N1 % N2 % ...Ni) & 1 N = number of values in a group SD = standard deviation of the values i = the last group of values The resultant long-term instrument SD and the laboratory-established mean for each lot number should be used to monitor instrument performance. Differential Percent Verification The differential percents (LYM, MID*, GRAN) are not stored in the Quality Control Logs. If statistical analysis of these parameters is required, it needs to be performed manually. The replicate files store only the absolute values for the three-part differential. To validate the differential percents, manually record the values from the RUN screen display or from a printout of each control run. The differential percentage data can then be used to calculate the mean values. These mean values (absolute values and/or percent values), in conjunction with the laboratory's established SDs, may be used to monitor the performance of a given lot of control material. *Referred to on the assay sheet as Mono. Westgard Rules Introduction A control file tests the control result against control limits to determine whether the CELL-DYN 1600 shows acceptable accuracy and precision. The limits are derived from the mean and standard deviation of control measurements obtained when the instrument performance is stable and acceptable. The most common rule used in hematology quality control is the mean ± 2SD limits. 95% of the control results should fall within the ± 2SD limits. Quality control rules detect random or systematic error. Random error may be defined as an increase in the SD (loss of precision); systematic error may be defined as a shift in the mean value (loss of accuracy). A multi-rule quality control procedure combines several control rules to improve the detection of both types of error. 7-6 CELL-DYN® 1600 Operator's Manual 9140214 Rev FCApril 1996 SEARCH BOOK TOC GO BACK Chapter 7 Quality Control CELL-DYN 1600 Westgard Rules The rules may be used singly or in combination depending on the operator preference. Selections are made on the QC FILE SETUP screen. When a rule is violated, the bulletin line displays the <WESTGARD WARNINGS: SEE LEVEY-JENNINGS> message. The number of the rule that was violated is displayed in place of the plus sign. The modified Westgard Rules available on the CELL-DYN 1600 are: Rule Violations Rule 1: Value outside 3SD A control result exceeded the mean " 3SD. Rule 2: 2 consecutive values outside the same 2SD 2 consecutive results fell outside 2SD on the same side of the mean. Rule 3: 2 consecutive values outside opposite 2SD 1 result was greater than 2SD above the mean and the next result was greater than 2SD below the mean. Consequently, the range between the results is greater than 4SD. Rule 4: 2 of 3 consecutive values outside the same 2SD 2 of the last 3 results fell outside 2SD on the same side of the mean. Rule 5: 4 consecutive values outside the same 1SD 4 consecutive results fell outside 1SD on the same side of the mean. Rule 6: 12 consecutive values on the same side of the mean 12 consecutive results fell on the same side of the mean. Only the directly measured parameters need to be monitored with multiple rules.1 In reference 1, (pp. 190-192), Cembrowski suggests a protocol for using the Westgard Rules in hematology. Following is a synopsis of that protocol. Since 3 levels of control are typically used to monitor a hematology analyzer, it is reasonable to consider all 3 runs at the same time. In other words, check for the rule violations across the 3 levels, not just within a particular level. If the same rule is violated for more than one level, determine whether the violation indicates a loss of precision or a loss of accuracy, and troubleshoot accordingly. CELL-DYN® 1600 Operator's Manual 9140214 Rev E—February 1994 7-7 SEARCH BOOK TOC GO BACK Quality Control Chapter 7 Cembrowski suggests that the results for all 3 levels first be checked to see if they are within their 2SD limits. If all 3 levels meet this criterion, the instrument is in control. If any control result exceeds the 2SD limits, check to see if it exceeds the 3SD limits. If a result exceeds 3SD, there is either an instrument problem or a problem with the particular level of control. Therefore, if a result exceeds 3SD, run another vial of that control. If the problem persists, then additional investigation is required. Check to see if either Rule 3 or Rule 4 has been violated for any level or across levels. If the problem is confined to one level of control, check for a Rule 2 violation for that level. Again, if the violations are confined to one level of control, use another vial and, if possible, another lot. Check expiration dates and data entry. Check to be sure that the control is run into the correct file. If a combination of rules has been violated across the 3 levels, determine whether the violations indicate a loss of precision or a loss of accuracy, and troubleshoot accordingly. If necessary, call the Abbott Customer Support Center for assistance. When the problem has been resolved, Cembrowski suggests that all levels be run again in duplicate to confirm that it has in fact been corrected. Commercial Controls QC Program A specific file (low control, normal control, or high control) is designated for each level of a commercial reference control: low abnormal, normal, high abnormal, respectively. Data is stored in the appropriate file for 30 runs. Specific multi-rules are activated or deactivated for each file via SETUP. Printed package insert reference mean and limits, the lot number, and the expiration date for control specimen in each file is also entered via SETUP. Parameter data obtained for any control run that falls outside of these entered limits display in inverse video and print underlined to alert the operator. QC file summary data or Levey-Jennings plot data currently in each file can be displayed and printed. Each time a QC specimen is run, the mean, standard deviation, and coefficient of variation for each parameter is calculated and updated automatically for current run data in each file. The operator can, at any time, reject any run with flagged (outside entered limits) data from this calculation. Additionally, the operator can delete any run from a QC file. 7-8 CELL-DYN® 1600 Operator's Manual 9140214 Rev E—February 1994 SEARCH BOOK TOC GO BACK Chapter 7 Quality Control Replicate Specimen QC Program Nine separate files are available for this program. Numeric data for each parameter, for up to 30 runs, stores in each file and can be displayed or printed at any time. Alerts, calculations, and plots are the same as those stated above for the commercial control QC program. SETUP is used to activate or deactivate the Westgard Rules and to enter comparison data. X-B Analysis QC Program Introduction X-B analysis is an automated means of monitoring instrument performance by using the known stability of the red cell indices. X-B represents the moving average of hematology values calculated using an algorithm developed by Dr. Brian Bull. The X-B analysis uses the Bull algorithm to monitor instrument performance by tracking the average red cell indices in the patient population analyzed on the instrument. The red cell indices MCV, MCH, and MCHC are known to be stable because the red cell apparently functions best in a very narrow range of size and hemoglobin content. Therefore, the body exerts tight physiologic control and varies the number of red cells before altering the average volume or hemoglobin concentration of those red cells. Consequently, the average red cell indices of a given patient population will vary no more than 0.5% from day to day and even year to year, providing the population does not change. The X-B algorithm provides a means of utilizing this information for quality control on the CELL-DYN 1600. The X-B algorithm analyzes the indices for MCV, MCH, and MCHC on the patient samples run through the instrument in batches of 20. Current batch data are then "smoothed" by using the mean from the previous batch multiple times in the calculation. As a result, each newly calculated batch mean includes data from previous batches. When the X-B program is ON and the patient specimen type is selected, the third line of the RUN screen displays the current X-B program status (e.g. <TYPE: PATIENT X-B: N/IN>; N is the number in the current batch and IN indicates the last batch was within the target and limits for all three parameters). In the DATA LOG, a B in front of a sequence number identifies each patient specimen accepted in the current X-B batch. CELL-DYN® 1600 Operator's Manual 9140214 Rev F—April 1996 7-9 SEARCH BOOK TOC GO BACK Quality Control Chapter 7 Lower/Upper Acceptance Limits The lower and upper limits determine which patient results will be used in the X-B moving average calculation. They should be set widely to exclude grossly abnormal samples or background counts but should include at least 95% of the patient results. Only results that fall within the set limits are used in the calculation. Target Value The Target Value for X-B is similar to the assay value for a commercial control. It is derived from the patient population analyzed on the instrument. Action Limit The Action Limit is the acceptable limit of variation around the target value. Establishing the Target Value A recent study2 by Dr. Bull collected data from 1767 hospitals and yielded the following mean values: • MCV 89.9 fL • MCH 30.5 pg • MCHC 33.9 g/dL These values confirmed values that Bull published in an earlier study3. Consequently, the values shown above can be used as the Target Values to initiate the X-B Analysis program. To establish setup X-B target values for MCV, MCH, and MCHC: 1. Turn the X-B moving average ON in SETUP. 2. At the X-B file setup, enter: • 90. for MCV • 30.5 for MCH • 33.9 for MCHC Laboratories seeing specialized patient populations, e.g., pediatric hospitals or tumor centers, may need to verify these values due to "abnormal" patient populations. Target values may be verified by evaluating approximately 400 samples and comparing the X-B means for those samples to the entered target values. This can be done as follows: 7-10 CELL-DYN® 1600 Operator's Manual 9140214 Rev F—April 1996 SEARCH BOOK TOC GO BACK Chapter 7 Quality Control 1. Collect data for a minimum of 20 batches. Calculate the mean, SD, and CV for each index using the batch means. The CV on 400 samples (20 batches) for each index should be less than 1.5%. (The 1.5% is one-half the allowable ± 3% action limit.) If the CVs are greater than 1.5%, an additional 400 samples should be evaluated. 2. If the CVs calculated in Step 1 are less than 1.5%, enter the mean as the confirmed target value. Interpreting X-B Results A suggested protocol and guidelines for interpreting X-B data can be found in Chapter 1 of Laboratory Hematology, An Account of Laboratory Techniques, edited by I. Chanarin.4 CELL-DYN Controls The CELL-DYN controls are packaged as follows: References • • Tri-level, 1 box, 2.5 mL vials x 12 Tri-level, 1 box, 3.0 mL tubes x 12 1. Cembrowski GS, Carey RN. Laboratory quality management, pp. 189, 190192. 2. Bull BS, Jones AR, Gibson M, Twedt D. A method for the independent assessment of the accuracy of hematology whole blood calibrators. AJCP (accepted for publication), 1992. 3. Bull BS, Hay KL. Are red blood cell indexes international? Arch Pathol Lab Med 1985; 109:604-606. 4. Chanarin I, ed. Laboratory hematology, an account of laboratory techniques. Edinburgh: Churchill Livingston, 1989:3-7. CELL-DYN® 1600 Operator's Manual 9140214 Rev E—February 1994 7-11 SEARCH BOOK TOC GO BACK Quality Control 7-12 Chapter 7 CELL-DYN® 1600 Operator's Manual 9140214 Rev E—February 1994 SEARCH BOOK TOC GO BACK Chapter 8 Precautions, Limitations and Hazards Precautions, Limitations and Hazards Limitations • The CELL-DYN® 1600 is designed for in vitro diagnostic use. • Abbott has designed the CELL-DYN 1600 system components for optimal performance. Substitution for reagents, calibrators, controls and components manufactured by other companies may adversely affect the performance of the Analyzer. • Follow the recommended maintenance schedules and procedures as outlined in Chapter 9, Maintenance, of this manual. • During the warranty period, all services and repair must be performed by Abbott authorized representatives. CAUTION Testing has shown that precision within stated claims is best maintained by priming the system after a specified idle time. Therefore, if the system has been idle for 15 minutes or more, a normal background should be run to ensure that the system is primed immediately prior to running any specimens. Location Requirements • An Abbott authorized representative must install the instrument. • Place the CELL-DYN 1600 Analyzer on a hard, level surface. Locate the system: – Away from direct sunlight – Away from the path of a cooled or heated air outlet – Away from drying ovens, centrifuges, x-ray equipment, CRTs or computers, video terminals, copiers, and ultrasonic cleaner. • Do not place reagent containers above the instrument. • The following space should be available to ensure proper ventilation: – – – CELL-DYN® 1600 Operator's Manual 9140214 Rev FCApril 1996 Benchtop space: 3 to 4 linear feet plus sufficient space for reagents Behind the instrument: 4 to 6 inches of space for proper ventilation Adequate space should be provided around the analyzer to perform necessary maintenance procedures. • Care should be taken to prevent blocking of the air vents on the sides and the back of the analyzer. • Before operating the instrument for the first time, verify that each reagent line is connected to the appropriate inlet and reagent container. 8-1 SEARCH BOOK TOC GO BACK Precautions, Limitations and Hazards • Chapter 8 Make sure the waste line is connected to the appropriate outlet and routed to a suitable waste container or drain. If the waste is routed to a waste container, make sure the waste sensor is properly connected. If the waste is routed to a drain, make sure a dummy plug is inserted in the waste sensor connector. Electrical Safety Precautions WARNING • Do not disconnect any electrical connection while the power is ON. • For continued protection from electric shock, use only approved power cords (such as those supplied). Connect power cords only to properly grounded outlets. Do not remove any instrument panel that is securely fastened in place by screws. Electrical shock hazard is increased whenever these panels are removed. • Replace only the externally accessible, labeled fuse located near the power cord connector. Use replacement fuse of the specified type and electrical rating only. Refer to Chapter 10, Troubleshooting, for detailed instructions. Mechanical Safety Precautions CAUTION Avoid contact with needle tips at all times (CS model) to prevent possible contamination with potentially infectious materials. • Wear gloves and safety glasses and use extreme caution when performing any maintenance procedures on the following components, as they can pinch or puncture: – Aspirate probe – Closed Sampler Needle (CS model) Infection Control 8-2 • Consider all clinical specimens and controls, calibrators, etc., that contain human blood or serum as potentially infectious. Use established, good, laboratory working practices when handling these samples. Wear gloves, lab coats and safety glasses and follow other biosafety practices as specified in the OSHA Bloodborne Pathogen Rule or other equivalent biosafety procedures. • Do not smoke, eat or drink in areas where test samples are handled. Do not pipette by mouth. CELL-DYN® 1600 Operator's Manual 9140214 Rev FCApril 1996 SEARCH BOOK TOC GO BACK Chapter 8 Precautions, Limitations and Hazards Decontamination Procedures • Decontaminate the instrument by performing the Auto-Clean cycle. This cycle flushes all of the fluid pathways with reagents to purge any waste from the fluid pathways. (The Open Sample Aspiration Probe and the CS Needle are automatically rinsed after every cycle.) The surfaces of the instrument should be wiped with a non-abrasive detergent solution to remove any soiling. This should be followed with a wipe with a 10% chlorine bleach solution. • If the instrument is to be shipped, it must be decontaminated prior to shipment. This is accomplished by the [PREPARE SHIPPING] key in the SPECIAL PROTOCOLS MENU. Instructions are given in the Non-Scheduled Maintenance section of Chapter 9, Maintenance. • Decontaminate and dispose of all specimens and potentially contaminated materials in accordance with local, state, and federal regulations. • Waste liquid is a possible source of biological and chemical hazard. Handle with extreme care during the disposal process. • Refer to the Sample Collection and Handling section in Chapter 5, Operating Instructions, for precautions and limitations pertaining to sample collection and handling. This section also includes information on interfering substances. Blood Samples Spills Clean up spills of potentially infectious materials in accordance with established biosafety practices. A generally accepted procedure for clean up of such spills is to absorb the spill with toweling or other absorbent material, wipe the area with a detergent solution and then wipe the area with an appropriate hospital disinfectant such as 10% chlorine bleach. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 8-3 SEARCH BOOK TOC GO BACK Precautions, Limitations and Hazards Chapter 8 Reagent Storage and Handling • Store reagents, calibrators and controls according to the directions in the enclosed package inserts. • Protect reagents from extreme heat and freezing during storage. Temperatures below 32oF (0oC) may cause layering that changes the tonicity and conductivity of the reagent. If freezing occurs, do not use the reagent. • Protect reagents from direct sunlight, evaporation and contamination. Use of the reagent container cap attached to each inlet tubing minimizes the latter two occurrences. • Never add remaining reagent from a container being replaced to a freshly opened container. This may contaminate the new reagent. • Never use a hemoglobin standard designed for use with reference cyanmethemoglobin methodology directly on the CELL-DYN 1600. The CELL-DYN 1600 uses a modified hemiglobincyanide method which is not designed to analyze these standards directly. Printer Precautions The printhead can get very hot during extended periods of printing. Allow it to cool before touching. 8-4 CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 SEARCH BOOK TOC GO BACK Chapter 9 Maintenance Maintenance Introduction The CELL-DYN® 1600 analyzer is designed to require minimal routine maintenance. For example: ! ! The fluidics are automatically rinsed between samples. The instrument is automatically placed in standby if it has been idle for 4 hours after the last cycle is completed. The operator is encouraged to routinely perform the required maintenance to lengthen the operational life of the analyzer and to minimize system problems that lead to imprecision and inaccuracy. This chapter describes the recommended preventive maintenance procedures and provides instructions for preparing the analyzer for an extended period of inactivity. NOTE Following maintenance, run commercial control or quality control (QC) specimens to confirm proper performance before running any unknown specimens. Many required preventive maintenance procedures have been automated on the CELLDYN 1600. These programs are accessed by pressing [SPECIAL PROTOCOLS] on the MAIN MENU. The SPECIAL PROTOCOLS screen is discussed in the next section. WARNING Consider all clinical specimens and controls, calibrators, etc. that contain human blood or serum as potentially infectious. Use established, good laboratory working practices when handling these samples. Wear gloves, lab coats and safety glasses and follow other biosafety practices as specified in the OSHA Bloodborne Pathogen Rule or other equivalent biosafety procedures. CAUTION Wear powder-free gloves when performing the maintenance procedures. If powderfree gloves are not available, rinse the gloves before performing the maintenance procedures. Powder from the gloves may cause instrument problems. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 9-1 SEARCH BOOK TOC GO BACK Maintenance Chapter 9 Following outlined maintenance schedules minimizes operational problems with the CELL-DYN 1600. The recommended intervals are based on the analyzer operating in laboratories that process samples from a general patient population. The intervals are affected by the volume of samples processed, the workload schedule, the operating environment, and the patient population that is analyzed. Each laboratory must assess its own situation and modify these recommended intervals as necessary. Overdue maintenance is usually indicated by imprecision of one or more of the directly measured parameters. This imprecision is due to carryover or dilution/sampling inconsistencies. If this occurs on more than a random basis, perform the appropriate maintenance more frequently than indicated. Special Protocols Menu The SPECIAL PROTOCOLS screen is the main screen used during maintenance procedures. It is accessed from the MAIN MENU by pressing [SPECIAL PROTOCOLS]. Preventive Maintenance Schedule Perform the following procedures at the scheduled time intervals. Daily 1. Daily shutdown (page 9-3) Weekly 1. Open sampler auto clean (page 9-4) 2. Aspiration probe exterior cleaning (page 9-5) 3. Closed sampler auto clean (for the CS model only) (page 9-6) 4. Closed sampler holder cleaning (for the CS model only) (page 9-7) 1. Lyse inlet tubing rinsing (page 9-8) 2. Rear fan filters cleaning (page 9-9) Monthly NOTE 9-2 To prepare for prolonged shutdown, refer to page 9-4. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 SEARCH BOOK TOC GO BACK Chapter 9 Maintenance As Required (for troubleshooting or corrective action) See the Nonscheduled Maintenance section for maintenance frequency. 1. Supplemental aperture cleaning (page 9-11) 2. Aperture plates cleaning (page 9-13) 3. Diluent syringe cleaning (page 9-16) 4. Sample syringe cleaning (page 9-19) 5. Sample aspiration probe interior cleaning (page 9-22) 6. HGB flow cell manual cleaning (page 9-24) 7. Vent line cleaning (page 9-26) 8. Accumulator draining and cleaning (page 9-27) 9. Preparing the analyzer for a prolonged period of non-use or for shipping (page 9-28) 10. Aspiration probe removal and replacement procedure (page 9-29) Daily Maintenance Procedures Daily Shutdown NOTE CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 Procedure 1. At the MAIN MENU, press [SPECIAL PROTOCOLS]. A new screen and new labels appear. 2. Press [MORE] twice. 3. Press [DAILY SHUTDOWN] to begin this cycle. <Process Active> appears on the screen. The Daily Shutdown cycle takes approximately 3 minutes. 4. Remove the lyse pump tubing from under the lyse pump rotor on the left side. 5. Record this maintenance in your maintenance log. When the cycle is complete, the analyzer should be left with the power ON. If so, reduce the screen brightness (by using the knob on the right side panel) to reduce the risk of burning the screen. If the instrument will not be used again within 24 hours, turn the power OFF. 9-3 SEARCH BOOK TOC GO BACK Maintenance Chapter 9 To prepare for prolonged shutdown: When the power will be turned OFF for more than 72 hours, perform the following procedure: 1. Remove the tubing from the lyse reagent container. 2. Perform the lyse inlet tube rinsing procedure. See the Monthly Maintenance section. 3. Immediately after the power is turned OFF, remove the following: ! ! ! WARNING 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. Do not forget to reinsert the tubes securely in the normally closed valves and under the lyse pump rotor (see Chapter 2, Installation) before turning the analyzer back ON. 4. Record this maintenance in your maintenance log. Weekly Maintenance Procedures Open Sampler Auto Clean Materials Required CELL-DYN Enzymatic Cleaner (at room temperature) Procedure 9-4 1. At the MAIN MENU, press [SPECIAL PROTOCOLS]. A new screen and new labels appear. 2. Press [AUTO CLEAN] to begin this cycle. 3. Place the vial of undiluted enzymatic cleaner concentrate under the sample probe. 4. Press [START CLEAN]. <Process Active> appears on the screen. The complete cycle takes approximately 11 minutes. 5. When the cycle completes, press [MAIN] to return to the MAIN MENU. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 SEARCH BOOK TOC GO BACK Chapter 9 Maintenance 6. Run background counts until acceptable results are obtained for all background parameters. 7. Run commercial controls or QC specimens to confirm the proper performance before running any unknown specimens. 8. Record this maintenance in your maintenance log. 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 the aspiration probe. However, routinely clean and disinfect the outside of the probe to ensure it moves freely through the wash block. This procedure can be done at any time (at least weekly) or in conjunction with other routine cleaning procedures. 1. With the power ON and aspiration probe down, carefully wipe the outside of the probe several times with a gauze dampened with diluted enzymatic cleaner. 2. Wipe the outside of the probe with a gauze dampened with distilled water. OR Run a background to rinse the probe. 3. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 Record this maintenance in your maintenance log. 9-5 SEARCH BOOK TOC GO BACK Maintenance Chapter 9 Closed Sampler Auto Clean Materials Required CELL-DYN Enzymatic Cleaner (at room temperature) Red top Vacutainer® tube (with no anticoagulant) Lint-free towel Procedure NOTE 9-6 1. Insert the tip of the enzymatic cleaner into the Vacutainer tube and fill it 3/4 full with cleaner. 2. Wipe the top of the Vacutainer tube with a lint-free towel to remove any excess cleaner and insert the stopper. Enzymatic cleaner is extremely slippery and any cleaner on the stopper or the top of the Vacutainer tube can cause the stopper to come off. 3. At the MAIN MENU, press [SPECIAL PROTOCOLS]. A new screen and new labels appear. 4. Confirm that the stopper is securely inserted on the Vacutainer tube containing the cleaner. Invert the tube and insert it into the closed sampler holder. 5. Press [START CLEAN]. <Process Active> displays on the screen. The Closed Sampler Auto Clean procedure takes approximately 8 minutes. 6. At the beep, remove the sample from the closed sampler holder. 7. When the cycle completes, press [MAIN] to return to the MAIN MENU. 8. Run background counts until acceptable results are obtained for all background parameters. 9. Run commercial controls or QC specimens to confirm proper performance before running any unknown specimens. 10. Record this maintenance in your maintenance log. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 SEARCH BOOK TOC GO BACK Chapter 9 Maintenance Closed Sampler Holder Cleaning Materials Required CELL-DYN Enzymatic Cleaner (at room temperature) or 5% sodium hypochlorite Cotton tip applicator Lint-free towel Procedure The closed sampler holder can be cleaned automatically via [CLEAN SAMPLER] from the SPECIAL PROTOCOLS screen. This key also aspirates liquid and spilled blood or cleaning fluid from inside the holder. A cotton tip applicator can also be used to clean the inside of the tube holder. WARNING NOTE CELL-DYN® 1600 Operator's Manual 9140214 Rev FCApril 1996 The tube holder contains a needle that presents a potential for injury when the operator places his or her fingers or hand in the path of the needle. 1. Swing the closed sampler holder arm to the side for better visibility of the well. 2. Insert the tip of the enzymatic cleaner into the inner well and fill it 3/4 full with cleaner. 3. At the MAIN MENU, press [SPECIAL PROTOCOLS]. A new screen and new labels appear. 4. Press [MORE] twice. 5. Press [CLEAN SAMPLER]. <Process Active> appears on the screen. Look for two parallel streams of diluent that flush the inner well. 6. Moisten a cotton tip applicator with enzymatic cleaner. Insert the tip into the inner well and clean the inner surface. 7. Press [CLEAN SAMPLER]. <Process Active> appears on the screen. 8. When the cycle completes, press [MAIN] to return to the MAIN MENU. 9. Record this maintenance in your maintenance log. 9-7 SEARCH BOOK TOC GO BACK Maintenance Chapter 9 Monthly Maintenance Procedures Lyse Inlet Tubing Rinsing Materials Required Medium size beaker Deionized water Procedure Replace the lyse pump tubing with the spare lyse pump replacement tubing at least every three months to ensure that it does not become pinched or restricted. NOTE If lyse pump tubing is replaced, verify lyse volume. Refer to Calibration, Chapter 6. IMPORTANT When the power is going to be turned OFF for 72 hours or longer, refer to Daily Maintenance Procedures, To prepare for prolonged shutdown, for additional steps. 1. Remove the lyse tubing from the lyse reagent container and place it into a container of warm deionized water. 2. At the MAIN MENU, press [SPECIAL PROTOCOLS]. A new screen and new labels appear. 3. Press [MORE] twice. 4. Press [LYSE PRIME] to begin the lyse priming cycle. 5. Press [LYSE PRIME] again a few times to perform multiple "lyse prime" cycles, which rinses the tubing with warm water. 6. Remove the lyse tubing from the water and press [LYSE PRIME] to cycle air through the tube. A. To continue operation immediately: 1. 9-8 Reinsert the tube into the lyse reagent and press [CLEAR ALARM]. Watch the Lyse Inlet tubing to verify lyse flow. CELL-DYN® 1600 Operator's Manual 9140214 Rev FCApril 1996 SEARCH BOOK TOC GO BACK Chapter 9 Maintenance B. 2. Perform 2 or 3 lyse prime cycles by pressing [LYSE PRIME]. 3. Run background counts until acceptable results are obtained for all background parameters. 4. Run commercial controls or QC specimens to confirm proper performance before running any unknown specimens. 5. Record this maintenance in your maintenance log. To prepare for prolonged shutdown (power OFF for over 72 hours): 1. Turn MAIN power switch OFF. 2. Perform Step 3, Chapter 9, Maintenance, Daily Maintenance Procedures, Daily Shutdown, To prepare for prolonded shutdown, to complete shutdown procedure. Rear Fan Filters Cleaning Materials Required Lint-free towels Procedure Rear cover fan filters are used to clean air passing through each of the rear fans. Clean them monthly to maintain a constant and unrestricted air flow. More frequent cleaning is required if the unit is located in a dusty area. NOTE CELL-DYN® 1600 Operator's Manual 9140214 Rev FCApril 1996 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. Some older model fan filters press off by lightly pressing and rotating the fan filter counterclockwise until it releases from the bracket notches holding it in place. 4. Remove the filters and run a medium pressure stream of warm water over each one. 5. Blot dry each filter with lint-free towels. 9-9 SEARCH BOOK TOC GO BACK Maintenance Chapter 9 6. Reinsert the cleaned filter into the bracket. 7. Turn the power switch to ON. After the analyzer is initialized, press [RUN] to continue. 8. Record this maintenance in your maintenance log. Nonscheduled Maintenance Frequency 9-10 Procedure Frequency Supplemental Aperture Cleaning When Auto Clean has not cleared a restriction or an 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 Cleaning When neither Auto Clean nor Supplemental Clean have 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 Cleaning When it is suspected to be the source of imprecision. NOTE Flaking of the white Teflon® plunger tip indicates replacement of syringe is necessary. Sample Syringe Cleaning This procedure is rarely necessary. 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 Probe Interior Cleaning When the sample aspiration probe is suspected to be the source of imprecision. HGB Flow Cell Manual Cleaning When Auto Clean has not cleared away a restriction or an organic build-up is suspected of causing any of the following: 1. Elevated HGB results 2. HGB imprecision Vent Line Cleaning When the vent line is restricted and prevents the formation of a proper meniscus in the metering tube. CELL-DYN® 1600 Operator's Manual 9140214 Rev FCApril 1996 SEARCH BOOK TOC GO BACK Chapter 9 Maintenance Procedure Frequency Vent Line Cleaning When the vent line is restricted and prevents the formation of a proper meniscus in the metering tube. Accumulator Draining and Cleaning 1. 2. Preparing the analyzer for a prolonged period of non-use or shipping 1. 2. 3. 4. When the alarm indicates that the accumulator is wet. When background counts exceed specification. Shipping the instrument. Storing the instrument. Prolonged period of non-use. When the entire plumbing system is suspected as the source of bacterial or fungal contamination. Nonscheduled Maintenance Procedures Supplemental Aperture Cleaning Materials Required 50% cleaning solution (5 mL of 5% sodium hypochlorite added to 5 mL of warm water) Small beaker Procedure This procedure is used to remove very stubborn restrictions in the RBC and WBC apertures, or when there is a marked increase in the RBC and/or WBC count times that cannot be solved by normal auto cleaning. If this procedure does not solve the problem, remove and clean the aperture plates. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 1. Ensure that the instrument is in the RUN mode and <READY> is displayed in the Status Box. 2. Remove the upper front cover. 3. Carefully pour the 50% cleaning solution into the pre-mix cup. 4. Carefully pour 5 mL of 5% sodium hypochlorite into the RBC bath. 5. Replace the upper front cover. 6. Wait two minutes to allow the pre-mix cup to soak. 7. After the soak period, press [SPECIMEN TYPE]. 9-11 SEARCH BOOK TOC GO BACK Maintenance NOTE Chapter 9 8. Press # key on the keyboard. The GAIN ADJUST screen displays. The cleaning solution in the pre-mix cup is transferred to the WBC bath. Both baths are bubble mixed. Wait another 2 minutes for the baths to soak. 9. Press the open probe touch plate to run three consecutive count cycles to aspirate the cleaning solution through the RBC and WBC apertures. If a <FLOW ERROR> or <CLOG> message displays, ignore it and continue to run the three counts. DO NOT use [CLEAR ORIFICE] because it will drain the cleaning solution from the cups. 10. Press [SPECIMEN TYPE]. 11. Press [NORMAL BACKGRND]. 12. Press [CLEAR ORIFICE] to reset the Running Average program and drain the baths. 13. Run background counts until acceptable results are obtained for all background parameters. 14. Run commercial controls or QC specimens to confirm proper performance before running any unknown specimens. 15. Record this maintenance in your maintenance log. The instrument is ready to run samples. It is recommended that the RBC and WBC count times be recorded for future reference to monitor protein build-up in the apertures. 9-12 CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 SEARCH BOOK TOC GO BACK Chapter 9 Maintenance Aperture Plates Cleaning Materials Required CELL-DYN Enzymatic Cleaner (at room temperature) or 5% sodium hypochlorite Sample vial Small beaker (50 mL) Camel hair aperture brush (included in the accessory kit) Deionized water Procedure 1. Remove the upper and lower front covers. Locate the RBC/PLT bath to the right of the probe. Locate the WBC bath to the left of the pre-mix cup. (See Figure 9-1.) Figure 9-1 Location of Dilution Baths CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 2. At the MAIN MENU, press [SPECIAL PROTOCOLS]. A new screen and new labels appear. 3. Press [DRAIN BATHS]. Both sides of each bath drain. 9-13 SEARCH BOOK TOC GO BACK Maintenance Chapter 9 4. Swing the red tagged plate holder (which holds the plates securely in place) to the right. (See Figure 9-2.) Figure 9-2 Aperture Plate Installation 5. Grasp the RBC/PLT aperture plate and pull it straight out from the transducer assembly until it is free of the mount. 6. Remove the WBC aperture plate using the same process. 7. Dispense 40 mL of warm deionized water into a beaker or other suitable container and add 40 drops of enzymatic cleaner (warm water enhances enzyme action). OR Dispense 15 mL of water into a beaker or suitable container and add 5 mL of 5% sodium hypochlorite. NOTE Diluted enzyme cleaner or sodium hypochlorite are most effective when they are prepared fresh each time this procedure is done. 8. WARNING 9-14 Clean debris from each aperture plate by rotating the camel hair aperture brush provided in the accessory kit. Use only the brush provided. Use of other items or brushes will damage the aperture plate. 9. Place each aperture plate into the beaker of cleaning solution prepared in step 7. Completely immerse each plate in the cleaning solution. Allow the plates to soak for AT LEAST 5 minutes and NO LONGER than 15 minutes. 10. Remove each aperture plate from the cleaning solution and thoroughly rinse it with a fine stream of deionized water. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 SEARCH BOOK TOC GO BACK Chapter 9 Maintenance To Reinstall the RBC/PLT Aperture Plate The RBC/PLT aperture plate is identified with "R/P" etched in the plate and is installed in the dilution bath to the right of the probe. NOTE 1. Position the "RBC/PLT" aperture plate so the notch is on the lower portion of the edge being inserted into the bath. 2. Insert the aperture plate into the slot between the two sections of the RBC/PLT dilution bath. Push the plate in until it is completely seated in the bath. 3. With the correct aperture plate placement, swing the red lever to your left to secure the plate in place. (There will be a slight resistance as you replace the red lever.) Be sure both the RBC/PLT and the WBC aperture plates are installed before filling the baths. To Reinstall the WBC Aperture Plate The WBC aperture plate is identified with "WBC" etched in the plate and is installed in the dilution bath to the left of the pre-mix cup. NOTE 1. Position the "WBC" aperture plate so the notch is on the lower portion of the edge being inserted into the bath. 2. Insert the aperture plate into the slot between the two sections of the WBC dilution bath. Push the plate in until it is completely seated in the bath. 3. With the correct aperture plate placement, swing the red lever to your left to secure the plate in place. (There will be a slight resistance as you replace the red lever.) Be sure both the RBC/PLT and the WBC aperture plates are installed before filling the baths. To Fill the Baths CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 1. Press [REFILL BATHS]. The flow systems are refilled. 2. Reinstall the lower and upper front covers. Press [MAIN] to return to the MAIN MENU. 9-15 SEARCH BOOK TOC GO BACK Maintenance Chapter 9 3. Run background counts until acceptable results are obtained for all background parameters. 4. Run commercial controls or QC specimens to confirm proper performance before running any unknown specimen. 5. Record this maintenance in your maintenance log. Diluent Syringe Cleaning Materials Required Large basin Deionized water Procedure 9-16 1. Obtain a large basin or suitable container to hold and soak the syringe. Add 2 to 3 inches of warm tap water to the container. 2. Confirm the analyzer is turned ON and the unit is INITIALIZED or READY. 3. Slide the door on the left side of the analyzer to expose the syringes. The diluent syringe is the large (10 mL) syringe. The sample syringe is the small (100 FL) syringe. 4. At the MAIN MENU, press [SPECIAL PROTOCOLS]. A new screen and new labels appear. 5. Press [CLEAN DIL SYRINGE]. The diluent syringe plunger moves up. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 SEARCH BOOK TOC GO BACK Chapter 9 Maintenance 6. Remove the large thumb nut at the bottom of the plunger by holding the calibration block with one hand and turning the large thumb nut clockwise (when viewed from above). (See Figure 9-3.) Figure 9-3 Diluent Syringe 7. CAUTION CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 Press [RESTORE SYRINGE] to move the black plunger holder down and allow the syringe to be removed. The plunger moves down, up, and down before stopping. 8. Loosen the small thumb nuts on the syringe holder block by turning them counterclockwise 2 complete turns. Pull the holder block away from the syringe to prevent breakage of the luer lock connector. Gently pull the syringe glass barrel towards you to ensure that it is completely free of the front and back sections of the syringe holder block. 9. Completely remove the small thumb nuts and front section of the holder block. 9-17 SEARCH BOOK TOC GO BACK Maintenance Chapter 9 10. WARNING WARNING Hold the syringe by the glass barrel and TURN IT CLOCKWISE (when viewed from above) to release it from its luer lock fitting. (See Figure 9-3.) Do not pull the syringe forward. Pull straight down. 11. Remove the spring clip from the barrel. 12. Immerse the complete syringe assembly in the container of warm water prepared in step 1. Allow it to soak for 1 to 2 minutes to dissolve accumulated salt deposits. 13. Pull the white plastic stopper out of the barrel of the syringe. Pour warm water into the barrel from the bottom of the syringe. Do not pull down, on, or otherwise move the plunger. Never push or pull on the plunger when the syringe is dry. 14. Remove the plunger from the barrel while the syringe is still immersed in warm water. Let the barrel and plunger soak in warm water for 5 minutes. Remove and rinse thoroughly with deionized water. Remove excess water by shaking, do not wipe. 15. Reassemble the syringe by: ! ! ! NOTE NOTE 9-18 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 When installing the clip, wedge the larger end of the clip on the lip of the barrel and the small end against the white plug. 16. Replace the syringe into the luer lock fitting by turning it counterclockwise (when viewed from above) until it is finger-tight. Do not overtighten. 17. Replace the front section of the syringe holder block. Secure it with the thumb nuts removed earlier. Install the thumb nut with the smaller diameter facing upward. Tighten the thumb nuts finger-tight with the beveled edge towards the holder. Do not overtighten. 18. Press [CLEAN DIL SYRINGE] to move the plunger up. Secure it in the plunger holder with the large thumb nut removed earlier. Install the thumb nut with the smaller diameter facing up. Tighten the large thumb nut to finger-tight while holding the calibration block. Do not overtighten. A small gap between the plunger holder and the thumb nut is normal. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 SEARCH BOOK TOC GO BACK Chapter 9 NOTE Maintenance 19. Press [RESTORE SYRINGE]. 20. Press [CLEAN DIL SYRINGE]. Check the syringe action for leaks, bubbles, and proper movement. Repeat this step if necessary. Bubbles may be present during the first filling. If they do not disappear, press [MORE] twice, then press [REAGENT PRIME] to clear the bubbles. 21. Return to the MAIN MENU and run 2 to 3 background counts. Watch the syringe action to make sure it fills and dispenses completely. 22. Run commercial controls or QC control specimens to confirm proper performance before running any unknown specimens. 23. Record this maintenance in your maintenance log. Sample Syringe Cleaning Materials Required Large basin Deionized water Procedure WARNING CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 1. At the MAIN MENU, press [SPECIAL PROTOCOLS]. A new screen and new labels appear. 2. Press [CLN SAMPL SYRINGE]. 3. Unscrew the bottom of the sample syringe by turning the bottom of the plunger counterclockwise (when viewed from above). (See Figure 9-4.) 4. Gently push up on the plunger until it clears the black stage. 5. Unscrew the collar of the syringe by turning the entire syringe clockwise (when viewed from above). 6. If there are saline crystals around the collar of the syringe, soak the entire syringe in warm water for 5 minutes. Then, gently pull the plunger rod completely out of the barrel and allow both pieces to soak for a few minutes. Do not touch the tip of the plunger with your hands. 9-19 SEARCH BOOK TOC GO BACK Maintenance Chapter 9 7. NOTE Rinse the syringe in deionized water and reassemble. If the syringe needs to be replaced, a new syringe may be installed. For complete instructions, see the next section. Do not push or pull on the plunger when the syringe is dry. Figure 9-4 Sample Syringe 9-20 CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 SEARCH BOOK TOC GO BACK Chapter 9 Maintenance To Reinstall or Replace the Sample Syringe 1. Push the plunger in all the way. Draw deionized water into the syringe so that the entire syringe is filled and the plunger is withdrawn as far as possible. Check for air bubbles. If there are air bubbles in the syringe, dispense and redraw water into the syringe. This procedure may have to be repeated several times to remove the air bubbles. 2. Screw the syringe tip into the fitting on the instrument by turning counterclockwise (when viewed from above). 3. Gently push up on the plunger until the end of the plunger just clears the stage. Screw the bottom of the plunger clockwise (when viewed from above) onto the stage. 4. Press [RESTORE SYRINGE]. 5. Press [CLN SAMPL SYRINGE], then press [RESTORE SYRINGE]. Watch for air bubbles. If air bubbles are present, press [CLN SAMPL SYRINGE] and [RESTORE SYRINGE] again. Repeat this process until there are no air bubbles. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 6. When the syringe is operating properly and there are no air bubbles, press [MORE] twice. A new screen and new labels appear. 7. Press [REAGENT PRIME] to prime the instrument before operating. 8. Press [MAIN] to return to the MAIN MENU. 9. Run commercial controls or QC specimens to confirm proper performance before running any unknown specimens. 10. Record this maintenance in your maintenance log. 9-21 SEARCH BOOK TOC GO BACK Maintenance Chapter 9 Sample Aspiration Probe Interior Cleaning Materials Required Syringe Sample cup Deionized water Cleaning solution (5 mL of 5% sodium hypochlorite added to 5 mL of water) Procedure 1. With the power ON, remove the upper cover. Press [RUN] to lower the probe. 2. Hold the 1/32" silicone tubing and carefully pull up on the 1/16" straight connector until it is free of the probe. (See Figure 9-5.) Figure 9-5 Sample Aspiration Probe Assembly NOTE 9-22 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. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 SEARCH BOOK TOC GO BACK Chapter 9 CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 Maintenance 5. Using a syringe filled with deionized water, rinse the probe several times from the top. 6. Reinsert the tubing into the probe and connector. 7. Run commercial controls or QC specimens to confirm proper performance before running any unknown specimens. 8. Record this maintenance in your maintenance log. 9-23 SEARCH BOOK TOC GO BACK Maintenance Chapter 9 HGB Flow Cell Manual Cleaning Materials Required Syringe cup (10 to 20cc with at least 3" long silicon tubing attached to tip) Cleaning solution (equal parts of 5% sodium hypochlorite and water) Wire solenoid valve-puller Deionized water Procedure NOTE 9-24 1. From the MAIN MENU screen, press [SPECIAL PROTOCOLS]. 2. Press [DRAIN BATHS]. 3. Remove the front panels. 4. Locate the HGB flow cell (located at the bottom left corner) and trace the top black tubing ending at the T-fitting. Do not tug on or place any undue stress on the other end of the black tubing's entrance point into the flow cell. 5. Disconnect the tubing on the right side of the T-fitting and attach a cleaning solution-filled syringe to the open end of the T-fitting. (See Figure 9-6.) 6. Attach the wire puller to pinch valve #26. 7. While holding the syringe base with your left hand, pull open valve #26 with your left index finger. 8. With the right hand push in the syringe plunger. 9. Inject at least 3/4 of the solution into the flow cell. 10. Alternately move the syringe plunger in and out several times to ensure optimum rinsing action. Leave the solution in the flow cell for 3 to 5 minutes. 11. Remove the syringe. 12. Drain the solution from the flow cell by pulling open valve #26. 13. Using deionized water, perform the same syringe injection procedure (steps 7 through 12) to flush out the solution thoroughly. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 SEARCH BOOK TOC GO BACK Chapter 9 Maintenance 14. Reconnect the tubing to the T-fitting. 15. Remove the wire puller. 16. Press [FILL BATHS]. 17. Return to the MAIN MENU screen. 18. Run at least 2 backgrounds to ensure acceptable results for all parameters. 19. Run commercial controls or QC specimens to confirm proper performance before running any unknown specimens. 20. Record this maintenance in your maintenance log. Figure 9-6 HGB Flow Cell Manual Cleaning CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 9-25 SEARCH BOOK TOC GO BACK Maintenance Chapter 9 Vent Line Cleaning Materials Required Sample vials OR 2 small beakers Deionized water Procedure NOTE 9-26 1. Locate the vent lines on both sides of the flow panel. Follow them to where they come to rest on the bottom. 2. Immerse the lines in a beaker or vial of deionized water. 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. 6. Record this maintenance in your maintenance log. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 SEARCH BOOK TOC GO BACK Chapter 9 Maintenance Accumulator Draining and Cleaning Materials Required Large syringe Large beaker Deionized water Procedure NOTE CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 1. Turn the analyzer OFF. 2. Locate and unclamp the accumulator tubing beneath the lyse pump assembly on the left side of the instrument. 3. Pull the plug and drain the tubing into an empty beaker. 4. Aspirate any remaining fluid from the tubing with an empty syringe. 5. Fill the accumulator with 400 to 500 cc of deionized water with a syringe. Due to the size of the syringe it may be necessary to clamp the lines and refill the syringe several times. 6. Open the clamp and drain the accumulator. 7. Use an empty syringe to aspirate any remaining water from the accumulator. 8. Clamp and replace the tubing. 9. Turn the instrument ON and reinitialize. 10. Run enough backgrounds (at least 2 or 3) to secure acceptable results for all background parameters. 11. Record this maintenance in your maintenance log. 9-27 SEARCH BOOK TOC GO BACK Maintenance Chapter 9 Preparing the Analyzer for a Prolonged Period of Non-Use or for Shipping Materials Required Deionized water Cardboard disk drive protector Disinfectant (cleaning solution); 1 part 5% sodium hypochlorite added to 9 parts deionized water Large beaker Plastic bag Procedure Salt deposits and reagent residue may damage the flow system if not removed before the CELL-DYN 1600 is stored (idle for two weeks or longer) or shipped. 9-28 1. At the MAIN MENU, press [SPECIAL PROTOCOLS]. A new screen and new labels appear. 2. Press [MORE] twice. 3. Press [CLEAN FOR SHIPPING]. The prompt screen displays. 4. Follow the screen prompts to rinse the flow system with deionized water. 5. Follow the screen prompts to purge water from the flow system. 6. Remove the lyse pump tubing from the lyse pump rotor. 7. Turn the power OFF. 8. Carefully remove the tubing from the normally closed (black octagon) valve on the upper left flow panel. 9. Remove each diluent and detergent inlet tube from its normally closed (black octagon) valve on the lower left side panel. 10. Remove the lower left side panel inlet and outlet tubing. The waste line should be emptied and rinsed with disinfectant. Place each tube in the protective bag. Place the bag in the accessory kit. Wipe the surface of the instrument with disinfectant. 11. Remove the diskette from the disk drive and insert the cardboard disk drive protector into the drive. 12. Remove the power cord from the outlet receptacle and rear cover connector. Place it in the accessory kit. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 SEARCH BOOK TOC GO BACK Chapter 9 Maintenance 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. NOTE Remove the upper cover. Make sure the aspiration probe is down before continuing this procedure. If it is not down, press [RUN] to lower it. 2. Hold the 1/32" silicone tubing and carefully pull up on the 1/16" straight connector until it is free of the probe. 3. Remove the probe holder clip. NOTE On older models, a second Allen screw was used to hold the probe in place. For these systems, follow steps 3.A. and 3.B. CAUTION Do not loosen the Allen screw on the probe alignment guide. See Figure 9-5. 4. WARNING NOTE CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 A. Use the 3/32" Allen wrench provided in the accessory kit to loosen the #4 Allen screw in the probe holder. B. Loosen the screws located on top of the wash block that hold the O-ring in place. Grasp the probe at the top and pull it up until it is free of the wash block. If the probe is bent or unable to be removed from the top, hold the probe to steady it. Remove the collar from the top of the probe. Pull down on the probe until it is free of the wash block. The probe collar determines the proper probe alignment and is factory set. Do not loosen the Allen screw in the collar of the replacement probe. 5. Insert it from the top into the probe holder and wash block. 6. With the collar flush with the probe holder, reinstall the probe holder clip with the curved portion down. For older models, tighten the Allen screw on the probe holder. 9-29 SEARCH BOOK TOC GO BACK Maintenance 9-30 Chapter 9 7. Hold the probe to steady it and insert the 1/16" straight connector completely into the 1/32" silicone tubing. 8. Reinstall the upper front cover. 9. Press [MAIN] to return to the MAIN MENU. 10. Run commercial controls or QC specimens to confirm proper performance before running any unknown specimens. 11. Record this maintenance in your maintenance log. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 Chapter 9 9140214 Rev FCApril 1996 CELL-DYN® 1600 Operator's Manual SEARCH BOOK TOC GO BACK Maintenance 9-31 Maintenance 9-32 SEARCH BOOK TOC GO BACK Chapter 9 9140214 Rev FCApril 1996 CELL-DYN® 1600 Operator's Manual SEARCH BOOK TOC GO BACK Chapter 10 Troubleshooting Troubleshooting Introduction This chapter gives instructions for identifying, troubleshooting, and correcting instrument problems. The CELL-DYN 1600® continuously monitors the status of the system and displays pertinent information in the status box. If a problem is detected within the system, the status box displays a message such as <LYSE EMPTY>,< WASTE FULL>, or <CLOG>. If a problem with the hardware occurs, the message <NOT READY. SEE DIAGNOSTICS> is displayed. The first section of this chapter discusses the DIAGNOSTICS MENU keypad labels. The remainder of the chapter is devoted to the Troubleshooting Guide. Diagnostics This section describes the keypad labels available from the four DIAGNOSTICS MENU screens when the instrument is initialized and primed. These keys enable the operator or service representative to obtain information and execute programs that assist in troubleshooting and to identify corrective action. When some keys are pressed, the message <FOR SERVICE USE ONLY> is displayed. The data these keys provide are meaningful only to trained field engineers and are not useful to the operator. If these keys are pressed inadvertently, the system may have to be initialized. The main DIAGNOSTICS MENU includes the following keys: [SYSTEM STATUS] [FAULT REPORT] [SERVICE HEX CODES] [SERVICE DEC CODE] [MORE] [PRINTER OUTPUT] [HELP] [MAIN] Each of these keys is described below. System Status [SYSTEM STATUS] displays a new screen that allows the operator or service personnel to review or print the current system status. Fault Report [FAULT REPORT] displays a new screen that allows the operator or service personnel to review or print the current fault status. Whenever the message <NOT READY. SEE DIAGNOSTICS> is displayed in the system status box, it is directing the operator to go to the diagnostics mode and press this key. Service Hex Codes This screen is not for operator use. It is for service personnel only. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 10-1 SEARCH BOOK TOC GO BACK Troubleshooting Chapter 10 Service Dec Code This screen is not for operator use. It is for service personnel only. More [MORE] displays a new screen and keypad labels that allow the operator to perform additional diagnostics to assist in troubleshooting. This key performs the same function on all diagnostic menus. Printer Output [PRINTER OUTPUT] allows the operator to print any screen by turning the printer output on before pressing another screen label. This also toggles the printer output OFF. The current printer status is displayed in the upper left section of the screen. This key performs the same function on all diagnostic menus. Help [HELP] steps the operator through one or more Help screens that define the screen keypad labels and the procedures to be performed. This key performs the same function on all menus. Main [MAIN] takes the operator back to the MAIN MENU and performs the same function on all diagnostic menus. When [MORE] is pressed, the second of four DIAGNOSTICS MENU screens is displayed. The following keys may be selected: [INITIALIZATION] [RAW DATA] [COUNT TEST] [MORE] [PRINTER OUTPUT] [HELP] [MAIN] These new keys are described below. Initialization [INITIALIZATION] is used to perform an initialization cycle. In the process, all motors are returned to the "home" position and all circuitry is checked. Raw Data [RAW DATA] displays the raw measurement data for the last specimen analyzed. 10-2 CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 SEARCH BOOK TOC GO BACK Chapter 10 Count Test Troubleshooting [COUNT TEST] is used to run a specimen and to display the count test data. The user is directed to place the specimen under the probe and to press [START]. The count test can also be used in the pre-dilute mode. Code data relating to specific cycle functions, raw measurement data, and flow count time data are displayed for use in troubleshooting or service. When [MORE] is pressed, the third of four diagnostic menus is displayed. The following keys may be selected: [WBC HISTOGRAM] [RBC HISTOGRAM] [PLT HISTOGRAM] [SMOOTHING OFF] [MORE] [PRINTER OUTPUT] [HELP] [MAIN] These keys are described below. WBC Histogram [WBC HISTOGRAM] is used to print the lysate-modified white cell count (numeric) data accumulated in each of 256 size channels. Each line contains data for 16 channels. For example, line 1 data are for channels 1 to 16, line 2 data are for channels 17 to 32, etc. Each size channel equals 1.367 femtoliters. RBC Histogram [RBC HISTOGRAM] is used to print the red cell count (numeric) data accumulated in each of 256 size channels. Each line contains data for 16 channels. For example, line 1 data are for channels 1 to 16, line 2 data are for channels 17 to 32, etc. Each size channel equals 1 femtoliter. PLT Histogram [PLT HISTOGRAM] is used to print the platelet count (numeric) data accumulated in each of 256 size channels. Each line contains data for 16 channels. For example, line 1 data are for channels 1 to 16, line 2 data are for channels 17 to 32, etc. Each size channel equals 0.1367 femtoliters. The histograms are displayed as numeric data and printed as graphic curves on the graphic printer. Alphanumeric data are printed if a ticket printer is connected to the graphic printer port. Smoothing Off [SMOOTHING OFF] is used to change the histogram display status. When smoothing is OFF and a histogram key is pressed, raw histogram data are shown. When [SMOOTHING OFF] is pressed while the status is OFF, the status changes to ON. When the status is ON and a histogram key is pressed, normalized and thresholdedited histogram data are shown. The number of the peak channel is also shown. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 10-3 SEARCH BOOK TOC GO BACK Troubleshooting Chapter 10 When [MORE] is pressed, the fourth of four DIAGNOSTIC MENU screens is displayed. The following keys may be selected: [PROBE HOME] [PROBE UP] [SAMPLE SYRINGE]/ [RESTORE SYRINGE] [DILUENT SYRINGE]/ [RESTORE SYRINGE] [MORE] [PRINTER OUTPUT] [HELP] [MAIN] These keys are described below. Probe Home [PROBE HOME] is used to lower the probe to the home position. Probe Up [PROBE UP] is used to raise the probe to the upper limit. Sample Syringe/Restore Syringe [SAMPLE SYRINGE] is used to time the sample syringe dispense cycle. [RESTORE SYRINGE] is used to time the sample syringe aspirate cycle. Diluent Syringe/Restore Syringe [DILUENT SYRINGE] is used to time the diluent syringe dispense cycle. [RESTORE SYRINGE] is used to time the diluent syringe aspirate cycle. More [MORE] displays a new screen and keypad labels that allow the operator to perform additional diagnostics to assist in troubleshooting. This key performs the same function on all diagnostic menus. Printer Output [PRINTER OUTPUT] allows the operator to print any screen by turning the printer output ON before pressing another screen label. This also toggles the printer output OFF. The current printer status is displayed in the upper left section of the screen. This key performs the same function on all diagnostic menus. Help [HELP] steps the operator through one or more Help screens that define the screen keypad labels and the procedures to be performed. This key performs the same function on all menus. Main [MAIN] takes the operator back to the MAIN MENU and performs the same function on all diagnostic menus. 10-4 CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 SEARCH BOOK TOC GO BACK Chapter 10 Troubleshooting Troubleshooting Guide The Troubleshooting Guide is designed to assist the operator in identifying and resolving instrument problems. Instructions are also given for obtaining technical assistance from the Abbott Customer Support Center. Introduction Good troubleshooting skills are learned by using a logical, step-by-step approach to problem solving. The first step in the process is understanding normal instrument operation and preventative maintenance. A good, working knowledge of the instrument is essential for identifying and resolving operational problems. Logical troubleshooting may be divided into three steps: 1. 2. 3. Problem Identification Problem Isolation Corrective Action Step 1, Problem Identification, is not only identifying what is wrong but also noting what is right. The investigation should identify the problem area and eliminate areas that are working correctly. Once this is done, the troubleshooting process moves quickly to the next step. Step 2, Problem Isolation, further classifies the problem. Instrument problems are generally divided into three categories: ! ! ! Hardware component related Software computer program related Measurement related to sample analysis Typically, hardware and software problems are corrected by an Abbott authorized service representative. Measurement problems are generally operator correctable. This category is further subdivided into problems related to sample handling, maintenance or calibration. Step 3, Corrective Action, involves taking appropriate action to correct the problem. If the operator can correct the problem, with or without technical assistance, normal operation can quickly resume. This Troubleshooting Guide is designed to enhance the troubleshooting process by providing information to assist in problem identification, isolation and corrective action. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 10-5 SEARCH BOOK TOC GO BACK Troubleshooting Chapter 10 Obtaining Technical Assistance Technical Assistance is obtained by calling the Abbott Customer Support Center. It is important to provide the Customer Support Specialist with a clear and detailed description of the problem. When assistance is needed, please be prepared to provide the following information for the Customer Support Specialist: 1. 2. 3. 4. 5. 10-6 Instrument model number Serial number of the analyzer and software version in use Description of the problem (whenever possible, print the fault status report obtainable from the DIAGNOSTICS MENU screen) The lot numbers and expiration dates of the CELL-DYN reagents and controls currently in use Examples of sufficient data to facilitate the discussion CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 SEARCH BOOK TOC GO BACK Chapter 10 Troubleshooting Troubleshooting Guide NOTE Generally, conditions that are instrument- or reagent-related will occur on all samples, including controls. Therefore, it is important to confirm instrument performance by rerunning controls and/or additional patient specimens. Table 10-1. Troubleshooting Guide Condition Probable Cause Required Action >>>> Data exceeds Display and Print capacity. For RBC or PLT: Dilute 0.5 mL aliquot of well-mixed whole 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 obtain a reportable value. appears in place of result. For WBC or PLT: Dilute 0.5 mL aliquot of well-mixed whole blood with 0.5 mL of diluent (1:2 ratio) or 1 mL (1:3), 1.5 mL (1:4), or 4.5 mL (1:10) of diluent as required. Close the container and invert it 10 to 15 times to mix. Run this specimen as usual. Multiply each WBC and PLT result by 2, 3, 4, or 10 (per ratio of diluent to blood used above) to obtain a reportable value. >>>> appears in place of RBC or PLT result. Abnormal or erratic HGB, MCH, and/or MCHC results. Wash block and probe misaligned. Perform the probe removal and replacement procedure described in Chapter 9, Maintenance. Confirm the probe is properly installed and aligned. Obtain technical assistance. Dirty HGB flow cell. Perform the hemoglobin flow cell manual cleaning procedure as described in Chapter 9, Maintenance. Lipemic sample or sample with WBC result above 50,000/FL. Specimen exceeds limitations of the procedure. See Chapter 5, Operating Instructions. Circuitry malfunction. Go to the diagnostics screen and press [PRINTER OUTPUT]. Press [RAW DATA]. Data display and print. Check the results for hemoglobin error. As required, obtain technical assistance. CELL-DYN® 1600 Operator's Manual 9140214 Rev FCApril 1996 10-7 SEARCH BOOK TOC GO BACK Troubleshooting Chapter 10 Table 10-1. Troubleshooting Guide (continued) Condition Probable Cause Required Action Background data are unacceptable. Interference from other electrical devices. Use dedicated power source or line voltage regulator; relocate instrument in an area free from interfering devices. Cold reagents—less than 59EF or 15EC. Allow reagents to warm. Rerun background check. If the background data are not acceptable, go to the next probable cause. Contaminated bath and/or aperture. Perform the Auto-Clean procedure described in Chapter 9, Maintenance. Contaminated diluent or detergent. Perform the procedures from Chapter 9, Maintenance, to prepare the unit for shipping. Use a 1:4 dilution of 5% sodium hypochlorite to water for cleaning and disinfecting the flow system. Repeat the procedure using distilled water. Rinse and refill the flow system with freshly opened containers of diluent and detergent. Contaminated lyse. Perform the lyse inlet tube rinse procedure described in Chapter 9, Maintenance. Install a freshly opened container of lyse. Diluent frozen in shipment. Replace with a new lot number or different shipment. Malfunctioning circuitry. Obtain technical assistance. Debris, fibrin clots, or protein build-up is restricting fluid flow through the aperture. Press [CLEAR ORIFICE] to backflush the aperture and reset the clog limit. If the situation occurs repeatedly, go to the SPECIAL PROTOCOLS MENU and run the Auto-Clean procedure. Perform manual aperture cleaning. Check the sample for fibrin clots or red cell agglutination. Redraw the specimen as required. Rerun the specimen if required. Flow system blockage resulting from a pinched tube in the diluent or detergent normally closed valve, or reagent particles may be in the flow panel. Remove the detergent inlet tube from the flow panel normally closed valve. Roll the tube between your fingers to unpinch it. Reinsert the tube in the valve. Repeat this process for the diluent tube. If the situation occurs repeatedly, perform the maintenance procedures to prepare the unit for shipping. Use a 1:4 ratio of 5% sodium hypochlorite to water. The message <CLOG> is displayed in place of Count Time. 10-8 CELL-DYN® 1600 Operator's Manual 9140214 Rev FCApril 1996 SEARCH BOOK TOC GO BACK Chapter 10 Troubleshooting Table 10-1. Troubleshooting Guide (continued) Condition Probable Cause Required Action The message Reagent with different conductivity was installed. Install only Abbott-recommended reagents as described in Chapter 2, Installation. <DETERGENT EMPTY> is displayed. The message <DILUENT EMPTY> is displayed. The message <FLOW ERR> NOTE Stated performance does not apply when other reagents are installed. Detergent is not being pulled into flow system. Exercise the tubing in normally closed valves. (Refer to Tube and Diluent Syringe Installation in Chapter 2, Installation.) Reagent with different conductivity was installed. Install only Abbott-recommended reagents as described in Chapter 2, Installation. NOTE Stated performance does not apply when other reagents are installed. Diluent is not being pulled into flow system. Exercise the tubing in normally closed valves. (Refer to Tube and Diluent Syringe Installation in Chapter 2, Installation.) Diluent syringe thumb nut has vibrated loose. With one hand holding steady the calibration block, confirm that the large knurled thumb nut on the bottom of the syringe is fully tightened—if not, tighten finger tight. Air bubbles are trapped in the dilution baths. Press [CLEAR ORIFICE] to backflush the aperture and reset the clog limit. Rerun the specimen. If the situation occurs repeatedly, go to the SPECIAL PROTOCOLS MENU and press [DRAIN] to drain the liquid from each bath. When the process is complete, press [REFILL BATHS]. This process removes any bubbles trapped inside the baths. Malfunctioning pinch valve. Raise the upper front cover and remove the lower front cover to gain access to the flow panel. Examine wash flow panel pinch valves to determine if each valve's press “T” can be moved—pushed in or pulled out when the valve is closed. Obtain technical assistance as required. is displayed in place of Count Time. CELL-DYN® 1600 Operator's Manual 9140214 Rev FCApril 1996 10-9 SEARCH BOOK TOC GO BACK Troubleshooting Chapter 10 Table 10-1. Troubleshooting Guide (continued) Condition Probable Cause Required Action The message Aperture plates installed in wrong baths. Check plate installation. Confirm that the aperture plate marked “R/P” is installed in the RBC/PLT bath located to the right of the probe. Confirm that the aperture plate marked “WBC” is installed in the other bath. Insufficient wetting of detergent reagent to form a good meniscus in the metering tube. Remove the upper and lower front covers to gain access to the flow panel. Press the white button (replaces touch plate) below the aspirate probe. Observe fluid flow and meniscus formation in each metering tube. When meniscus formation is poor, prepare the analyzer for shipping as described in Chapter 9, Maintenance. Rinse the flow tubes and install a freshly opened container of detergent. As required, obtain technical assistance. <FLOW ERR> or <CLOG> is displayed in place of both Count Times. (WBC/RBC). Insufficient liquid in the bath. Air is drawn through the aperture. Remove the upper front cover and open the left panel to gain access to the flow panel and syringe panel. Press the touch plate. Observe the action of the diluent syringe and the fluid flow in and out of each bath. If the syringe action is not complete, perform the diluent syringe cleaning procedure described in Chapter 9, Maintenance. As required, obtain technical assistance. Check the system for leaks or cracks. Flow system leak. Damaged aperture. INITIALIZED 10-10 Power-on initialization cycle was performed. Check the aperture under a microscope using a low power objective lens with external light source. If damage is observed, obtain a replacement aperture plate. Verify calibration after replacement. The unit is NOT primed. To run specimens, press [RUN]. CELL-DYN® 1600 Operator's Manual 9140214 Rev FCApril 1996 SEARCH BOOK TOC GO BACK Chapter 10 Troubleshooting Table 10-1. Troubleshooting Guide (continued) Condition Probable Cause Required Action Keypad selection or entry not accepted. Computer busy performing a function that prevents screen label selection. Refer to the screen for current status messages; counting, etc. None required. Data being transmitted to printer or computer. None required. Keypad entry not allowed for this screen. Computer, keypad, and/or circuitry malfunction. The message <LYSE EMPTY> is Reagent with different conductivity was installed. displayed. Turn the power OFF. Wait 30 seconds. Turn the power back ON. If the situation is not corrected, obtain technical assistance. Install only Abbott-recommended reagents as described in Chapter 2, Installation. NOTE Stated performance does not apply when other reagents are installed. No liquid was detected by the internal lyse sensor. Lyse pump tubing is worn out. Lyse inlet tubing is clogged. Confirm that the end of the lyse tube is immersed in reagent. When the container is empty, replace it with a fresh container of lyse. Press [CLEAR FAULT]. Replace lyse pump tubing if there are signs of deterioration or if the tubing is over 3 months old. Perform lyse inlet tubing flush procedure. NOTE Never pour the reagent remaining in an old container into a freshly opened container. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 10-11 SEARCH BOOK TOC GO BACK Troubleshooting Chapter 10 Table 10-1. Troubleshooting Guide (continued) Condition Probable Cause Required Action No power. Power cord is loose or not securely connected to the unit or wall socket. Confirm that the power cord is inserted securely into both the rear panel connector and wall outlet(s). Confirm that the plug prongs are not bent. Power switch is OFF. Move the rear panel power switch to ON. No voltage or wrong voltage at the lab power receptacle. No screen display. No screen labels. QC specimen results exceed acceptable limits. Run cycle will not stop. 10-12 Confirm that the fuse and circuit breaker at facility (site) are acceptable. Confirm that the analyzer's rear panel voltage selector PCB and fuse are correct for the power provided. Defective power switch. Obtain technical assistance. Instrument malfunction. Obtain technical assistance. The screen brightness adjustment knob is turned down. Turn the brightness knob clockwise to adjust brightness. Incoming power fluctuation. Turn power OFF, wait 30 seconds, turn power back ON. Cycle in process but not complete. None. Refer to the screen for current status. Incomplete data entry. To abandon the unfinished operator entry process and redisplay the screen labels, press [ENTER]. Improper mixing or handling of the QC specimen. Refer to Chapter 7, Quality Control, for the proper handling of QC specimens. Dilution error. Rerun specimen. If the situation occurs again, perform the Auto-Clean procedure and/or the diluent syringe cleaning procedures described in Chapter 9, Maintenance. Insufficient or no dilution mixing. Remove the upper front cover. Press the touch plate. Observe the bubble mix in each bath. As required, obtain technical assistance. Defective diskette or diskette drive. Turn the power switch OFF. Replace the system diskette with the spare supplied with the analyzer. Obtain technical assistance. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 SEARCH BOOK TOC GO BACK Chapter 10 Troubleshooting Table 10-1. Troubleshooting Guide (continued) Condition Probable Cause Required Action Specimen will not aspirate. Fibrin or debris is in the specimen aspiration probe. Check the specimen for fibrin clots or red cell agglutination. Redraw the specimen as required. Check the probe for fibrin clots, salt deposits, etc. Remove and clean the probe or replace it. Vacuum or circuitry malfunction. Obtain technical assistance. STANDBY No run cycle was activated for 4 hours. The auto-shutdown cycle was activated, placing the unit in standby. Press [RUN] to run auto-startup, prime the unit, and perform a background check. The message Instrument hardware malfunction detected during initialization cycle. Go to the DIAGNOSTICS MENU screen. A message pertaining to the computer-detected malfunction is displayed with the required operator action. As required, obtain technical assistance. Liquid level in the waste container has tripped the sensors. Remove the waste stopper assembly and empty the container. Press [CLEAR FAULT] to continue. Make sure liquid is wiped from stopper and top of bottle to ensure good seal. <UNINITIALIZED, SEE DIAGNOSTICS> is displayed. The message <WASTE FULL> is displayed. CAUTION Liquid is a possible biological and chemical hazard. Follow good laboratory safety practices. Waste sensor plug is not inserted completely in lower left side panel receptacle. An audible tone sounds to alert the operator. Reinsert the plug into receptacle, then press [CLEAR FAULT] to continue. Turn power OFF. Wait 10 seconds, then turn power ON. Obtain technical assistance. Defective component. Waste full, no message displayed. Waste sensor plug dirty. Clean plug with alcohol and reinsert fully. Loose wire in waste cap. Obtain technical assistance. CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 10-13 SEARCH BOOK TOC GO BACK Troubleshooting Chapter 10 Table 10-1. Troubleshooting Guide (continued) Condition Probable Cause Required Action WBC and/or HGB data are invalid. No lyse reagent added. Pinched or cracked lyse tubing. Malfunction of lyse pump or pinch valve. Remove lyse tube from flow panel normally closed valve and roll it between your fingers. If it remains flat, replace the tubing. Insert the tube in the valve. Go to the SPECIAL PROTOCOLS screen and press [LYSE PRIME]. Observe the action of the lyse pump (lower left). Confirm that lyse dispenses into the WBC bath during the prime cycle. As required, do the lyse tubing rinse procedure described in Chapter 9, Maintenance, or obtain technical assistance. Verify lyse volume. X-B data are out for MCH and/or MCHC. Dirty HGB flow cell. Perform the hemoglobin flow cell manual cleaning procedure as described in Chapter 9, Maintenance. Amount or timing of lyse addition not optimal. Perform the lyse inlet rinsing procedure described in Chapter 9, Maintenance. Check tubes for cracks and leaks. As required, obtain technical assistance. Dirty aperture. Clean aperture plate as described in Chapter 9, Maintenance. As required, obtain technical assistance. X-B data are out for MCV. 10-14 CELL-DYN® 1600 Operator's Manual 9140214 Rev DCJune 1993 SEARCH BOOK TOC GO BACK Chapter 11 Printers Printers Introduction The CELL-DYN7 1600 is configured with a graphics printer. The printer is set up to print reports, including complete graphic information, on continuous tractor-feed paper. Graphics Printer This section gives a brief overview of Graphics Printer maintenance and troubleshooting. Instructions for installation are given in the Printer Installation section of Chapter 2, Installation. For a detailed description of the printer components and instructions on changing the ribbon and loading paper, refer to the manuals that accompany the printer. The CELL-DYN 1600 software automatically controls and adjusts most print conditions. Occasionally, a few settings may need to be changed in the printer software for correct operation. If printing is not what you expect, refer to the printer manual for guidance in making adjustments. If you have additional questions or experience any problems, call the Abbott Customer Support Center for assistance. Troubleshooting Refer to the printer manuals for a list of the most common printer problems and how to solve them. If the problem is not resolved, contact the Abbott Customer Support Center for assistance. NOTE If, during routine system operation, the message <PRINTER UNAVAILABLE> is displayed, check to see that the printer cable is securely connected to the data module, the printer power switch is turned ON, and that the Select indicator is illuminated. Press [PRINT] . If the message is still displayed, turn the printer power OFF, wait about 5 seconds, turn the power ON again and press [PRINT] . If the message is still displayed, there may be an internal printer error. Contact the Abbott Customer Support Center for assistance. Ticket Printer If ticket printing is desired for the CELL-DYN 1600, a second printer (known as the Ticket Printer) can be connected to the system at the same time as the graphics printer. Instructions for the installation of both printers are given in the Printer Installation section of Chapter 2, Installation. Complete directions for customizing the printout type and format are given in the Setup System Operation section of Chapter 2, Installation. For detailed information about loading paper and changing the ribbon in the ticket printer, refer to the manuals that accompany the printer. In particular, note the important safety instructions. CELL-DYN7 1600 Operator's Manual 9140214 Rev DCJune 1993 11-1 SEARCH BOOK TOC GO BACK Printers Chapter 11 Printing Tickets To print tickets, the printer cable must be connected to the ticket printer connector on the right side of the data module. (See Figure 2-1 for the location of these connectors.) Refer to the Customize Printout section in the Setup System Operation section of Chapter 2, Installation, for instructions for customizing either type of printout. Maintenance Every 6 months (or after about 300 hours of operation), use a clean, dry cloth to dust the area around the carriage shaft and platen. Be sure to remove any loose particles of paper. Do not use solvents or strong detergents on the cabinet. Be sure to turn the printer OFF before cleaning. Troubleshooting Refer to the printer manuals for a list of the most common printer problems and how to solve them. If the problem is not resolved, contact the Abbott Customer Support Center for assistance. NOTE 11-2 If, during routine system operation, the message <PRINTER UNAVAILABLE> is displayed on the bulletin line, check to see that the printer cable is securely connected to the data module, the printer power switch is turned ON, and that the Select indicator is illuminated. Press [PRINT] . If the message is still displayed, turn the printer power OFF, wait about 5 seconds, turn the power ON again and press [PRINT] . If the message is still displayed, there may be an internal printer error. Contact the Abbott Customer Support Center for assistance. CELL-DYN7 1600 Operator's Manual 9140214 Rev DCJune 1993 SEARCH BOOK TOC GO BACK Chapter 12 CELL-DYN® 1600CS CELL-DYN 1600CS Closed Sample Aspiration Module NOTE This addendum describes the installation, operation, and maintenance of the CELLDYN 1600CS Closed Sample Aspiration Module. To install and operate this module, the CELL-DYN 1600 must be fully operational. Refer to the following chapters for more information on the installation, setup, and operation of the CELLDYN 1600. ! ! Introduction Installation and setup Operating instructions Chapter 2 Chapter 5 The CELL-DYN 1600CS is a multi-parameter, automated hematology analyzer designed for in vitro use in clinical laboratories. It is, in essence, the CELL-DYN 1600 with the added capability to aspirate specimens from a closed collection tube. The Closed Sample Aspiration Module is a factory-installed option for the CELLDYN 1600. It is activated by a touch plate below the module's safety door. When the touch plate is activated, a specimen is aspirated from a closed collection tube and pumped to the sample container in the closed sampler module. The specimen probe then aspirates the proper volume from the sample container and performs the WBC and RBC/PLT measurements described in the other chapters of this manual. WARNING Consider all clinical specimens and controls, calibrators, etc. that contain human blood or serum as potentially infectious. Use established, good laboratory working practices when handling these samples. Wear gloves, lab coats and safety glasses and follow other biosafety practices as specified in the OSHA Bloodborne Pathogen Rule or other equivalent biosafety procedures. CAUTION Wear powder-free gloves when performing the maintenance procedures. If powderfree gloves are not available, rinse the gloves before performing the maintenance procedures. Powder from the gloves may cause instrument problems. System Components The closed sample aspiration module is mounted on a door that is hinged at the left and attached to the CELL-DYN 1600 by a thumbscrew on the right side of the module. CELL-DYN® 1600 Operator's Manual 9140214 Rev ECFebruary 1994 12-1 SEARCH BOOK TOC GO BACK CELL-DYN® 1600CS Chapter 12 The front panel of the module includes the following components: Figure 12-1 Closed Sampler ! ! ! ! ! Flow Panel A tube holder (2) for the closed collection tube. The holder contains a needle to pierce the collection tube stopper. An adjustable tube guide (3) to correctly position the tube in the holder. A movable safety door (1) with a safety interlock that prevents cycle activation via the touch plate unless the door is closed. The touch plate (4) activates the closed sample aspiration cycle. The touch plate is not operational when the safety door is open. The thumbscrew (5) attaches the closed sampler module to the front panel. When loosened, the module swings open to allow access to the module's internal flow panel. The closed sampler Internal Flow Panel is located on the inside of the module door. To access the flow panel, unscrew the thumbscrew located on the right side of the module and swing the door out toward you. Figure 12-2 Internal Flow Panel 12-2 CELL-DYN® 1600 Operator's Manual 9140214 Rev ECFebruary 1994 SEARCH BOOK TOC GO BACK Chapter 12 CELL-DYN® 1600CS The closed sample aspiration module internal flow panel includes the following components: ! ! ! Two peristaltic pumps located near the bottom of the module door. Next to each pump is a pump tube holder and two tube stops. The tube stops are designed to prevent the tube from moving during pump rotor action. Four normally closed valves above the two peristaltic pumps. A sample container into which the specimen is pumped after it is aspirated from the closed collection tube. Closed Sample Aspiration Module Installation Refer to Chapter 2, Installation, for CELL-DYN 1600 installation procedures. The instrument must be operational before the closed sample aspiration module can function properly. The closed sample aspiration module is shipped with the internal flow panel peristaltic pump tubes and normally closed valve tubes removed. CAUTION CAUTION 1. Turn the thumbscrew on the right side of the module counterclockwise until the door swings open. 2. Pull the module door toward you. 3. Locate the peristaltic pumps, the pump tube holders, and the tube stops located above and below each pump rotor. 4. Insert the ends of the pump tube into the two tube stops. 5. Push the upper end of the tube holder away from the pump rotor. 6. While holding the tube holder away from the rotor, insert the pump tube between the pump rotor and the tube holder. Make sure the tubing is not crimped or pinched. 7. Repeat steps 1-6 to place the second pump tube under the second rotor. 8. Locate the normally closed valve and the valve tube. Carefully stretch the tube and insert it into the valve opening. Work the tube back and forth gently until it is completely seated in the valve. Make sure the tubing is not crimped or pinched. CELL-DYN® 1600 Operator's Manual 9140214 Rev ECFebruary 1994 12-3 SEARCH BOOK TOC GO BACK CELL-DYN® 1600CS Chapter 12 Tube Guide Adjustment Procedure The tube guide of the closed sampler module is factory set to accept 75 mm high Vacutainer® tubes. As required, the tube guide can be adjusted to accept Vacutainer tubes that are 100 mm high. An Allen wrench is included in the accessory kit for use in making this adjustment. 1. Locate and remove the Allen wrench provided in the accessory kit. 2. Move the tube guide to the left to gain access to the lower guide clamp and nut. Figure 12-3 Tube Guide 12-4 3. Insert the Allen wrench into the lower clamp nut and turn the wrench counterclockwise to loosen it. (The clamp slides freely on the rod.) 4. Insert the Allen wrench into the upper clamp nut and loosen it. 5. Insert the new size Vacutainer® tube into the holder. 6. Slide the clamp down or up as required until it is properly positioned to hold the tube. 7. Press down lightly on the guide to provide a slight tension on the spring. 8. Tighten the upper clamp nut while holding the guide down. 9. Remove the Vacutainer tube and tighten the lower clamp nut. CELL-DYN® 1600 Operator's Manual 9140214 Rev ECFebruary 1994 SEARCH BOOK TOC GO BACK Chapter 12 CELL-DYN® 1600CS 10. Insert and remove the new size Vacutainer tube from five to ten times to confirm that both clamp nuts are tight. Overview of the Run Mode Only specimens collected in a standard Vacutainer tube, either 75 mm or 100 mm high, and containing EDTA anticoagulant can be run via the closed sample aspiration module. The specimens should be no more than four hours old to provide the most accurate results for all parameters. <CLS> appears on line 3 of the upper left RUN MENU. <C> appears after the Sequence # in the data log and QC files to designate that the specimen was run via the closed sampler. The CELL-DYN 1600CS is ready to run samples in the closed sample aspiration module after the power-on initialization and startup cycles. Run Procedure CAUTION Follow the same preparation steps to run the closed sample as you would to run an open sample. Refer to Chapter 5, Operating Instructions, for instructions. 1. Pull the closed sample aspiration module safety door forward. 2. Invert the well-mixed specimen and place it in the tube holder. Confirm that the bottom of the tube is securely seated in the tube clamp. 3. Close the safety door. 4. Press the closed sampler touch plate. 5. Review the results on the RUN screen. 6. Repeat steps 1 through 5 for any additional samples to be run. If the system has been idle for 15 minutes or more, a normal background should be run immediately prior to running any patient specimens. Verification and Calibration No significant difference between specimens run by the open aspiration mode and the closed aspiration mode was observed during clinical evaluations. However, mode to mode verification should be done any time calibration of the system is performed. CELL-DYN® 1600 Operator's Manual 9140214 Rev F—April 1996 12-5 12-5 SEARCH BOOK TOC GO BACK CELL-DYN® 1600CS Chapter 12 Closed Mode Calibration Verification 1. Confirm that the system has been properly calibrated in the open mode as outlined in Chapter 6, Calibration. 2. Obtain a normal fresh whole blood sample. A full 7 mL tube is required. In an empty replicate file, run the sample five times in the open mode and five times in the closed mode. 3. The C.V. values for each parameter must meet the following criteria: WBC RBC HGB MCV PLT ≤ 2.5% ≤ 1.7% ≤ 1.2% ≤ 1.5% ≤ 6.0% Refer to System Specifications, Chapter 4, for acceptable ranges. Calibration 4. If all parameters are within these limits, document in your laboratory's instrument log book that closed mode calibration verification has been performed. No further action is required. 5. If one or more parameters do not meet this criteria, repeat the procedure using a different whole blood sample. 6. If the results from the second sample fail to meet the above criteria for any parameter, contact the Abbott Customer Support Center for assistance. Refer to Chapter 6, Calibration, regarding recommended guidelines for calibration frequency. Materials Required • • • 12-6 12-6 A minimum of five different fresh whole blood samples. All parameter values should be within the laboratory's normal range. Refer to sample requirements for fresh whole blood, Chapter 6, Calibration. Each sample must have sufficient volume to be run three times in both the open and closed mode. Therefore, it is advisable to select full 5 mL tubes. Calculator Mode to Mode Verification & Calibration Worksheet CELL-DYN® 1600 Operator's Manual 9140214 Rev F—April 1996 SEARCH BOOK TOC GO BACK Chapter 12 Procedure CELL-DYN® 1600CS 1. Confirm that the background counts are acceptable and precision is within established limits (see Chapter 4, System Specifications). 2. Confirm calibration of the open mode by running all three levels of commercial controls. Refer to the calibration procedure in the operator's manual if open mode calibration is required. 3. Select two replicate files to be used for the determination of the mean value for each mode. Purge any existing data in each file. 4. Determine the Open Mode Mean as follows: A. From the RUN MENU, press [SPECIMEN TYPE] and the number of the first file. B. Run each well-mixed sample two times into the file in the open mode. C. Go to the QC MENU and choose the same file. D. Press [PRINT DATA]. 5. Determine the Closed Mode Mean as follows: A. From the RUN MENU, press [SPECIMEN TYPE] and the number of the second file. B. Run each well-mixed sample (the same samples as in Step 4) two times into the file in the closed mode. C. Go to the QC MENU and choose the same file. D. Press [PRINT DATA]. 6. Use worksheet section #1 to calculate the Mode to Mode Calibration Bias. 7. Enter the percent Bias for each parameter in worksheet section #2. If all parameters are within the validation range, document in your laboratory's instrument log book that verification has been completed. Calibration is not necessary and no further action is required. If any parameters require calibration, continue with the next section. Closed Mode Calibration 1. CELL-DYN® 1600 Operator's Manual 9140214 Rev ECFebruary 1994 From the RUN MENU, press [MAIN]. 12-7 SEARCH BOOK TOC GO BACK CELL-DYN® 1600CS Chapter 12 2. Press [CALIBRATION]. 3. Enter the digits: 9 4 0 4 3. 4. Press [PRINT] to obtain a printout of the current Whole Blood Dilution Factors for the Open Sample and Closed Sample. The Dilution Factors are provided to adjust for mode to mode variation. 5. Record the Closed Sample Dilution Factors on worksheet section #3. 6. Record the Open Mode means and the Closed Mode means (Step 4) on worksheet section #3. 7. Use worksheet section #3 to calculate factors for the parameters that require calibration. Enter the new Closed Sample Dilution Factors. 8. Confirm Closed Mode Calibration as follows: A. Purge the replicate file in which you ran the closed mode samples. B. Re-run the same five well-mixed samples at least once each into this file in the closed mode. C. Go to QC and choose this file. D. Print data. E. Using worksheet section #4, calculate the percent Bias. F. If the calibration bias exceeds these established limits, verify that all calculations were correct and that the new factors were entered correctly. If no errors are detected, call the Abbott Customer Support Center for assistance. Quality Control Complete instructions for Quality Control are given in chapter 7. The following procedure may be used to verify the performance of the Closed Sampler mode of operation. 12-8 CELL-DYN® 1600 Operator's Manual 9140214 Rev ECFebruary 1994 SEARCH BOOK TOC GO BACK Chapter 12 CELL-DYN® 1600CS Mode to Mode QC Verification Good laboratory practice mandates that controls be run in all modes in which samples will be run. CELL-DYN control materials may be run in the Open or Closed mode on those CELL-DYN Systems with two modes of operation. Patient samples can be assayed in the Open mode after verifying that CELL-DYN controls fall within the laboratory's acceptable limits. These samples may then be used to verify the operation of the Closed mode. The following is a suggested procedure for using patient samples to verify the operation of the Closed mode. Procedure NOTE 1. Run a minimum of two levels of control in the Open mode at the beginning of each eight hours of operation prior to running patient samples. Control samples must be run in the same manner as patient samples. 2. When control results are within the laboratory's acceptable limits, record the results and process patient samples in the Open mode. 3. Select three normal patient samples from the Open mode run. Sample results should fall within the laboratory's normal range. Two samples may be used but three are preferred. 4. NOTE CELL-DYN® 1600 Operator's Manual 9140214 Rev F—April 1996 Select and configure three replicate files, one for each sample, for Mode to Mode verification. Replicate files store only the absolute values for the three-part differential. If you wish to validate the differential percents (%LYM, %MID, %GRAN), you must manually record the values directly from the RUN SCREEN or from the printout of each control run. The differential percentage data taken from the individual control runs must be used to manually calculate the mean differential percentages. 5. Run the first selected patient sample in the Open mode in the replicate file configured for sample 1. Run the second and third samples in the Open mode in their respective files. 6. Run the first normal patient sample in the Closed mode in the replicate file configured for sample 1. Run the second and third samples in the Closed mode in their respective files. 12-9 12-9 SEARCH BOOK TOC GO BACK CELL-DYN® 1600CS Chapter 12 7. 8. NOTE 12-10 12-10 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 Results from at least two of the three samples must fall within the established range for all parameters. When the results are within the established range, record the difference between the Open and Closed mode results on the logsheet provided and process patient samples in the Closed mode. A Mode to Mode QC Verification logsheet is provided at the end of this section for recording the differences. This logsheet may be duplicated as needed. 9. Maintenance Verify that the Closed mode results match the Open mode results within the laboratory's acceptable limits. The following ranges are provided as a guideline. If results are outside the established range, contact the Customer Support Center for assistance. Complete maintenance instructions are given in Chapter 9. In addition to the Open Mode maintenance, the following Closed Sampler maintenance should be performed weekly: 1. Perform the Closed Sampler Auto-Clean procedure as directed in Chapter 9. 2. Clean the Closed Sampler Holder as directed in the procedure given in Chapter 9. 3. Check the peristaltic pump tubing and replace as needed. CELL-DYN® 1600 Operator's Manual 9140214 Rev F—April 1996 SEARCH BOOK TOC GO BACK Chapter 12 CELL-DYN® 1600CS Mode to Mode Verification & Calibration Worksheet Date: ________________________________ Name: _______________________________ Calculate all calibration factors to three decimal places Mode to Mode Calibration Bias % Bias = Closed Mode Mean - Open Mode MeanX 100 Open Mode Mean #1 Closed Mode Mean - Open Mode Mean ÷ Open Mode Mean X 100 = WBC - ÷ X 100 = RBC - ÷ X 100 = HGB - ÷ X 100 = MCV - ÷ X 100 = PLT - ÷ X 100 = % Bias Mode to Mode Calibration Criteria #2 Validation Range Cal Not Required Calibration Range Cal Needed Calibration Limit Do Not Cal* 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% % Bias * CELL-DYN® 1600 Operator's Manual 9140214 Rev F—April 1996 Cal? Y or N Do not calibrate. Call the Abbott Customer Support Center for assistance . 12-11 12-11 SEARCH BOOK TOC GO BACK CELL-DYN® 1600CS Chapter 12 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 Closed Mode Mean Current Closed Factor* = New Closed Sample Dilution Factor #3 Open Mode Mean ÷ Closed Mode Mean Closed Sample Dilution Factor* x = New Closed Sample Dilution Factor Range** WBC ÷ x = 0.700 - 1.300 RBC ÷ x = 0.800 - 1.200 HGB ÷ x = 0.700 - 1.300 MCV ÷ x = 0.700 - 1.300 PLT ÷ x = 0.700 - 1.300 * Current factor printed in Step 4. ** If factor exceeds limits, Do Not Calibrate. Check all calculations and call Technical Service for assistance. Mode to Mode Post-Calibration Bias % Bias = Closed Mode Mean - Open Mode Mean X 100 Open Mode Mean #4 Closed Mode Mean* - Open Mode Mean ÷ Open Mode 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. 12-12 CELL-DYN® 1600 Operator's Manual 9140214 Rev FCApril 1996 SEARCH BOOK TOC GO BACK CELL-DYN 1600 Mode to Mode QC Verification Daily Differences Logsheet Month:____________ DATE SAMPLE ID NO. 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 Instrument:_____________ WBC RBC HGB MCV PLT MPV LYM MID GRAN %LY %MID %GRAN TECH SEARCH BOOK TOC GO BACK CELL-DYN® 1600CS 12-14 Chapter 12 CELL-DYN® 1600 Operator's Manual 9140214 Rev ECFebruary 1994 SEARCH BOOK TOC GO BACK Tables Table T-1: Potential Causes of Erroneous Results with Automated Cell Counters PARAMETER CAUSES OF SPURIOUS INCREASE CAUSES OF SPURIOUS DECREASE W HITE CELL COUNT (WBC) Cryoglobulin, cryofibrinogen Heparin Monoclonal proteins Nucleated red cells Platelets clumping Unlysed red cells Clotting Smudge cells Uremia plus immunosuppressants RED CELL COUNT (RBC) Cryoglobulin, cryofibrinogen Giant platelets Elevated white cell count (> 50,000/µL) Cold agglutinins Clotted specimen (microclot) Hemolysis (in vitro) Polycythemia (increased RBC coincidence) Microcytic red cells HEMOGLOBIN (HGB) Carboxyhemoglobin (> 10%) Cryoglobulin, cryofibrinogen Hemolysis (in vivo) Elevated white cell count Hyperbilirubinemia, severe Lipemia Abnormal plasma proteins Clotted specimen (microclot) HEMATOCRIT (PACKED CELL VOLUME - ANALYZER METHOD) Cryoglobulin, cryofibrinogen Giant platelets Elevated white cell count Hyperglycemia (> 600 mg/dL) Autoagglutination Clotted specimen (microclot) Specimen hemolysis HEMATOCRIT (PACKED CELL VOLUME - MANUAL METHOD) Hyponatremia Plasma trapping Excess EDTA Hemolysis (in vitro) Hypernatremia MEAN CELL VOLUME Autoagglutination High white cell count (> 50,000/µL) Hyperglycemia Reduced red cell deformability Cryoglobulin, cryofibrinogen Giant platelets Hemolysis (in vitro) Microcytic red cells Swollen red cells MEAN CELL HEMOGLOBIN High white cell count (> 50,000/µL) Spuriously high hemoglobin Spuriously low red cell count Spuriously low hemoglobin Spuriously high red cell count MEAN CELL HEMOGLOBIN CONCENTRATION Autoagglutination Clotting Hemolysis (in vivo and in vitro) Spuriously high hemoglobin Spuriously low hematocrit High white cell count (> 50,000/uL) Spuriously low hemoglobin Spuriously high red cell count PLATELETS (PLT) Cryoglobulin, cryofibrinogen Hemolysis (in vivo and in vitro) Microcytic red cells Red cell inclusions White cell fragments Clotting Giant platelets Heparin Platelet clumping Platelet satellitosis CELL-DYN® 1600 Operator's Manual 9140214 Rev D — June 1993 Tables-1 SEARCH BOOK TOC GO BACK Tables Table T-2: Normal Values for Automated Blood Counters PARAMETER ADULT MALE >18 YEARS ADULT FEMALE >18 YEARS CHILDREN AT 1 MONTH CHILDREN AT 2 YEARS CHILDREN 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 Differential mv denotes mean value For adult black males and females, normal WBC is 2.9 K/µL - 7.7 K/µL For adult black males and females, normal RBC, HGB and HCT is 5% less For children age 6 months to 18 years, mean MCV value is approximately 75 + (0.8 x age in years) For newborns, MCV is 88 - 114 and RDW is 14.9 - 18.7 Tables-2 CELL-DYN® 1600 Operator's Manual 9140214 Rev D — June 1993 SEARCH BOOK TOC GO BACK Tables Table T-3: Anemia Classification Based on MCV and RDW MCV (LOW) RDW (NORMAL) RDW (HIGH) MCV (NORMAL) MCV (HIGH) Non-anemic heterozygous thalassemia Chronic disease Children Normal Chronic disease Non-anemic hemoglobin abnormalities Non-anemic enzyme abnormalities Chronic lymphocytic leukemia Splenectomy Acute blood loss Chronic liver disease Chronic myelogenous leukemia Cytotoxic chemotherapy Aplastic anemia Hyperglycemia Chronic liver disease Chronic myelogenous leukemia Cytotoxic chemotherapy Iron Deficiency Hgb S-Alpha or Beta Thalassemia Hgb H Early or mixed nutritional deficiency Anemic hemoglobin abnormalities Myelofibrosis Sideroblastic Myelodysplasia Chronic liver disease Chronic myelogenous leukemia Cytotoxic chemotherapy Folate or vitamin B12 deficiency Sickle cell anemia (1/3 of cases) Immune hemolytic anemia Cold agglutinins Preleukemia Newborn Chronic liver disease Chronic myelogenous leukemia Cytotoxic chemotherapy Table T-4: Progressive Stages of Iron Deficiency STAGE IRON STORES * RDW MCV HGB DEPLETION Reduced Normal Normal Normal HETEROGENEOUS Reduced High Normal Normal MICROCYTIC Reduced High Low Normal ANEMIC Reduced High Low Low * Marrow stainable iron; ferritin; or transferrin saturation CELL-DYN® 1600 Operator's Manual 9140214 Rev D — June 1993 Tables-3 SEARCH BOOK TOC GO BACK Tables Table T-5: Morphophysiologic Classification of Red Cell Disorders ANEMIA MCV (LOW) MCV (NORMAL) MCV (HIGH) HYPOPROLIFERATIVE DISORDERS: RDW (NORMAL) Chronic disease Chronic disease Aplastic anemia Iron deficiency Sideroblastic Early iron, folate, or vitamin B12 deficiency Sideroblastic Folate, or vitamin B12 deficiency Sideroblastic NUTRITIONAL DISORDERS: RDW (HIGH) HEMOLYTIC DISORDERS: RDW is increased proportionally to degree of anemia. RDW (NORMAL) RDW (HIGH) Thalassemia trait or carrier AS, AC, non-anemic hemoglobinopathies Chronic non-anemic enzyme or membrane defects Thalassemia itermedia or H disease S-beta thalassemia SS and alpha thalassemia Hgb SS Hgb SS Red cell fragments post-transfusion Cold agglutinins Hyperglycemia Chronic lymphocytic leukemia ARTIFACTS: Histogram abnormal RDW (HIGH) Red cell fragments Source: Adapted from Bessman, Gilmer, and Gardner 1983 Table T-6: Result Abnormalities Caused by Artifacts ITEM RBC HGB HCT MCV MCH MCHC HISTOGRAM ARTIFACT LOCATION RED CELL FRAGMENTS ↓ ↑ ↓ ↓ ↑ ↑ < 80 fL LYMPHOCYTE ↑ N ↑ ↑ ↓ ↓ >180 fL RED CELL AGGLUTINATION ↓ N ↓ ↑ ↑ ↑ 150 - 170 fL HYPERGLYCEMIA N N ↑ ↑ N ↓ ----- FREE PLASMA HEMOGLOBIN N ↑ N N ↑ ↑ ----- ↓ = Decreased; ↑ = Increased; N = Normal Tables-4 CELL-DYN® 1600 Operator's Manual 9140214 Rev D — June 1993 ">

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Key features
- Closed-tube sampling
- Multi-parameter analysis
- Automated operation
- On-screen data display
- Data storage on disk drive
- Printer output