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Printer Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7 Ticket Printer Installation Procedure . . . . . . . . . . . . . . . . 2-10 Sample Loader Set Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12 Instrument Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15 Relocation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-19

Chapter 3: Principles of Operation Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-1 Sample Aspiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3 Sample Analysis Cycle Overview . . . . . . . . . . . . . . . . . . . . . . . . . .3-5 WBC Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5 RBC/PLT Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6 Reticulocyte Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6 Hemoglobin Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7 Results Displayed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7 Instrument Rinsed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7 WBC Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-9 WIC/WOC Interaction . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9 WIC Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10 WOC Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13 WBC Differential Analysis . . . . . . . . . . . . . . . . . . . . . . . . 3-19 WBC Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25 WBC Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-26 RBC/PLT Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-27 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-27 Electrical Impedance Measurements . . . . . . . . . . . . . . . . 3-27 Coincidence Passage Correction . . . . . . . . . . . . . . . . . . . 3-27 RER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28 Volumetric Metering . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28 RBC/PLT Measurement Process . . . . . . . . . . . . . . . . . . . . 3-29 RBC Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-30 RBC Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-31 Reticulocytes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-32 PLT Measurement Process . . . . . . . . . . . . . . . . . . . . . . . . 3-32 PLT Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-33 Platelet Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-34 Hemoglobin Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-35 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-35 Hemoglobin Measurement Process . . . . . . . . . . . . . . . . . 3-35 HGB Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-36 Operational Messages and Data Flagging . . . . . . . . . . . . . . . . . . . 3-37 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-37 Interfering Substances . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-37 Instrument Fault and Status Messages . . . . . . . . . . . . . . . 3-38 Parameter Flagging Messages . . . . . . . . . . . . . . . . . . . . . . 3-39 Master Table of Contents - 2

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Introduction to WBC Flagging . . . . . . . . . . . . . . . . . . . . . 3-42 Cell Populations and Flagging . . . . . . . . . . . . . . . . . . . . . 3-45 Flagging Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-49 WBC Descriptors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-49 Suspect Parameter Flags . . . . . . . . . . . . . . . . . . . . . . . . . . 3-50 Suspect Population Flags . . . . . . . . . . . . . . . . . . . . . . . . . 3-54 Flagging Diagnostics Screen . . . . . . . . . . . . . . . . . . . . . . . 3-59 Interpretive Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-60 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-63

Chapter 4: System Specification Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 CELL-DYN 3700SL System Specifications . . . . . . . . . . . . . . . . . . . 4-3 Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3 Power Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4 Operational Specifications . . . . . . . . . . . . . . . . . . . . . . . . . 4-6 Bar Code Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7 CELL-DYN 3700CS System Specifications . . . . . . . . . . . . . . . . . . . 4-9 Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9 Power Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10 Operational Specifications . . . . . . . . . . . . . . . . . . . . . . . . 4-11 Combined Specifications for the SL and CS Systems . . . . . . . . . 4-13 Measurement Specifications . . . . . . . . . . . . . . . . . . . . . . . 4-13 Performance Specifications . . . . . . . . . . . . . . . . . . . . . . . 4-15 Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . 4-20 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25

Chapter 5: Operating Instructions Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1 Instrument Logbook . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1 Data Station Program Overview . . . . . . . . . . . . . . . . . . . . . 5-2 Conventions Used in This Manual . . . . . . . . . . . . . . . . . . . 5-5 Menu Flowcharts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6 Set Up Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13 Date/Time Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14 Patient Limits Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16 Reagent Log Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-19 QC Set Up Menu Soft Key . . . . . . . . . . . . . . . . . . . . . . . . 5-21 Operation Set Up Soft Key . . . . . . . . . . . . . . . . . . . . . . . . 5-43 Units Selection Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . 5-49 Customize Report Soft Key . . . . . . . . . . . . . . . . . . . . . . . . 5-51 Routine Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-67 Run Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-68 Run Screen Soft Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-74 Sample Collection and Handling . . . . . . . . . . . . . . . . . . . 5-87

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Sample Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-89 Instrument Start Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-92 Sample Analysis Using the SL Model . . . . . . . . . . . . . . . . 5-92 Sample Analysis Using the CS Model . . . . . . . . . . . . . . . . 5-99 Using The Work List . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-103 Sample Analysis Using the Work List . . . . . . . . . . . . . . . 5-114 Using The Data Log. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-121 Data Log Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-122 Data Log Set Up Procedures . . . . . . . . . . . . . . . . . . . . . . 5-135 Data Review from the Data Log . . . . . . . . . . . . . . . . . . . 5-140 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-143

Chapter 6: Calibration Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-1 When to Calibrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1 Open and Closed Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2 Calibration Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3 Calibration Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3 Calibration Procedural Summary . . . . . . . . . . . . . . . . . . . 6-11 Conventions Used in this Chapter . . . . . . . . . . . . . . . . . . 6-11 Calibration Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13 Calibration Menu Flowchart . . . . . . . . . . . . . . . . . . . . . . 6-13 Calibration Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-14 Open Sampler/Closed Sampler Soft Key . . . . . . . . . . . . . 6-15 Print Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15 Main Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16 Enter Factor Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16 Calibration Log Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . 6-18 Auto-Calibrate Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19 Pre-Calibration Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-27 Calibration Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-27 Pre-Calibration Procedures Checklist . . . . . . . . . . . . . . . . 6-29 Auto-Cal Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-33 Auto-Cal Sample Capacity . . . . . . . . . . . . . . . . . . . . . . . . 6-34 Auto-Cal Methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-34 Calibration Requirements for Auto-Cal . . . . . . . . . . . . . . 6-35 Auto-Cal Using Calibrator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-37 Starting Auto-Cal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-37 Entering the Reference Values . . . . . . . . . . . . . . . . . . . . . 6-37 Collecting the Calibration Data . . . . . . . . . . . . . . . . . . . . 6-38 Calibration Factor Calculation . . . . . . . . . . . . . . . . . . . . . 6-40 Determining Which Parameters Need Calibration . . . . . 6-41 Calibrating All Parameters . . . . . . . . . . . . . . . . . . . . . . . . 6-43 Calibrating Individual Parameters . . . . . . . . . . . . . . . . . . 6-44 Completing Open Mode Calibration . . . . . . . . . . . . . . . . 6-44 Auto-Cal Calibration Criteria Worksheet . . . . . . . . . . . . . 6-45

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Auto-Cal Using Whole Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-47 Starting Auto-Cal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-47 Entering the Reference Values . . . . . . . . . . . . . . . . . . . . . 6-48 Collecting the Calibration Data . . . . . . . . . . . . . . . . . . . . 6-48 Calibration Factor Calculation . . . . . . . . . . . . . . . . . . . . . 6-50 Determining Which Parameters Need Calibration . . . . . 6-52 Calibrating All Parameters . . . . . . . . . . . . . . . . . . . . . . . . 6-54 Calibrating Individual Parameters . . . . . . . . . . . . . . . . . . 6-55 Completing Whole Blood Open Mode Calibration . . . . . 6-55 Auto-Cal Calibration Criteria Worksheet . . . . . . . . . . . . . 6-57 Manual Calibration Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-59 Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-60 Manual Calibration Procedure — Open Mode. . . . . . . . . . . . . . . 6-61 Preparing for Manual Calibration . . . . . . . . . . . . . . . . . . 6-61 Determining the Open Mode Mean . . . . . . . . . . . . . . . . . 6-61 Calibration Factor Calculations . . . . . . . . . . . . . . . . . . . . 6-62 Determining Which Parameters Need Calibration . . . . . 6-63 Calibrating the Open Mode . . . . . . . . . . . . . . . . . . . . . . . 6-65 Completing Manual Calibration . . . . . . . . . . . . . . . . . . . 6-66 Manual Calibration Worksheet . . . . . . . . . . . . . . . . . . . . 6-68 Mode To Mode Calibration Overview . . . . . . . . . . . . . . . . . . . . . 6-71 Auto-Cal Mode to Mode Calibration . . . . . . . . . . . . . . . . 6-71 Manual Mode to Mode Calibration . . . . . . . . . . . . . . . . . 6-72 Mode to Mode Calibration Preparation . . . . . . . . . . . . . . 6-72 Closed Mode Calibration Confirmation . . . . . . . . . . . . . 6-72 Mode To Mode Auto-Cal Calibration (Closed Sampler Only) . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-73 Determining Reference Values . . . . . . . . . . . . . . . . . . . . . 6-73 Starting Auto-Cal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-74 Entering the Reference Values . . . . . . . . . . . . . . . . . . . . . 6-74 Collecting the Calibration Data . . . . . . . . . . . . . . . . . . . . 6-75 Calibration Factor Calculation . . . . . . . . . . . . . . . . . . . . . 6-77 Determining Which Parameters Need Calibration . . . . . 6-78 Calibrating All Parameters . . . . . . . . . . . . . . . . . . . . . . . . 6-80 Calibrating Individual Parameters . . . . . . . . . . . . . . . . . . 6-81 Completing Mode to Mode Calibration . . . . . . . . . . . . . . 6-82 Optional Calibration Confirmation . . . . . . . . . . . . . . . . . 6-82 Mode to Mode Auto-Cal Calibration Criteria Worksheet 6-83 Manual Mode to Mode Calibration (CS or SL) . . . . . . . . . . . . . . 6-85 Preparing for Manual Mode to Mode Calibration . . . . . . 6-85 Determining the Open Mode Mean . . . . . . . . . . . . . . . . . 6-85 Determining the Closed Mode Mean . . . . . . . . . . . . . . . . 6-86 Percent Difference Calculation . . . . . . . . . . . . . . . . . . . . 6-87 Determining Which Parameters Need Calibration . . . . . 6-88 Calibration Factor Calculation . . . . . . . . . . . . . . . . . . . . . 6-90 Calibrating the Closed Mode . . . . . . . . . . . . . . . . . . . . . . 6-90

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Completing Mode to Mode Calibration . . . . . . . . . . . . . . 6-91 Optional Calibration Confirmation . . . . . . . . . . . . . . . . . 6-91 Manual Mode to Mode Calibration Worksheet . . . . . . . . 6-93 Post-Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-95 Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-95 Calibration Backup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-95 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-99

Chapter 7: Quality Control Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-1 Quality Control Menu Flowchart . . . . . . . . . . . . . . . . . . . . 7-2 Quality Control Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-3 X-B File Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4 View QC Log Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8 Quality Control Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15 Running Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15 Westgard® Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-17 X-B Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-20 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-27

Chapter 8: Hazards Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1 Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1 Warning Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1 Hazard Information and Precautions. . . . . . . . . . . . . . . . . . . . . . .8-3 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3 Biohazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3 Handling and Disposing of Biohazardous Materials . . . . . 8-4 Chemical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4 Electrical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5 Physical and Mechanical Hazards . . . . . . . . . . . . . . . . . . . 8-6 Laser Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11

Chapter 9: Maintenance Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-1 Preventive Maintenance Schedule . . . . . . . . . . . . . . . . . . . 9-2 Analyzer Flow Panel Components Diagram . . . . . . . . . . . . 9-2 Decontamination Procedures . . . . . . . . . . . . . . . . . . . . . . . 9-4 Special Protocols Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-5 Emptying the Transducers . . . . . . . . . . . . . . . . . . . . . . . . . 9-6 Draining the Reagent Reservoirs . . . . . . . . . . . . . . . . . . . . 9-7 Accessing the Maintenance Log . . . . . . . . . . . . . . . . . . . . . 9-8 Accessing the Shear Valve . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9

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Disabling/Enabling the Analyzer . . . . . . . . . . . . . . . . . . . . 9-9 Special Protocols Screen #2 . . . . . . . . . . . . . . . . . . . . . . . 9-10 Maintenance Log Set Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13 Interval Set Up Procedure . . . . . . . . . . . . . . . . . . . . . . . . . 9-15 Update Maintenance Log Procedure . . . . . . . . . . . . . . . . 9-16 Daily Maintenance Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . 9-19 Auto-Clean . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-19 Sample Loader Aspiration Needle . . . . . . . . . . . . . . . . . . 9-21 Closed Sampler Aspiration Needle . . . . . . . . . . . . . . . . . . 9-22 Weekly Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . 9-23 Shear Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-23 Sample Aspiration Peristaltic Pump Tubing . . . . . . . . . . . 9-26 Sample Loader Tray, Racks, and Safety Cover . . . . . . . . . 9-27 Extended Auto Clean . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-28 Monthly Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . 9-29 Reagent Syringes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-29 Analyzer Air Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-32 WOC Transfer Peristaltic Pump Tubing . . . . . . . . . . . . . . 9-33 Extended Auto-Clean . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-35 As Required. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-37 10-mL Reagent Syringe . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-37 Aperture Plates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-39 Hemoglobin Flow Cell Manual Cleaning . . . . . . . . . . . . . 9-43 Unclogging the Open Sample Aspiration Probe . . . . . . . 9-45 Bar Code Reader Window . . . . . . . . . . . . . . . . . . . . . . . . . 9-46 Flushing the “Y” Fitting — Open and Closed Modes . . . . 9-47 Special Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-51 Closed Sampler Tube Retainer Adjustment (CS System Only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-51 Preparation for Inactivity or Shipping . . . . . . . . . . . . . . . 9-52 Repackaging for Shipment . . . . . . . . . . . . . . . . . . . . . . . . 9-54

Chapter 10: Troubleshooting Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1 Diagnostics Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3 Diagnostics Menu Flowchart . . . . . . . . . . . . . . . . . . . . . . 10-4 Troubleshooting Guide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-27 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-27 Troubleshooting Procedures . . . . . . . . . . . . . . . . . . . . . 10-29 Replaceable Components . . . . . . . . . . . . . . . . . . . . . . . . 10-32 List of Symptoms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-38 Symptom Identification and Resolution . . . . . . . . . . . . 10-39 List of Messages and Fault Conditions . . . . . . . . . . . . . . 10-66 Messages and Fault Conditions . . . . . . . . . . . . . . . . . . . 10-68

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Master Table of Contents

Chapter 11: Printers Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1 Routine Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3 Graphics Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3 Ticket Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3 Maintenance and Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . 11-5 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5

Chapter 12: Sample Loader Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1 Bar Code Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3 CELL-DYN Bar Code Labels . . . . . . . . . . . . . . . . . . . . . . . 12-3 CELL-DYN Q Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3 Bar Code Label Placement . . . . . . . . . . . . . . . . . . . . . . . . 12-3 Sample Loader Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5 Main Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5 Tower Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-7 Operating Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-9 Functional Description . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-9 Function Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-12 Routine Operating Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . 12-15 Operating Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-15 Other Chapters to Reference . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-17 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-17 Set Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-17 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-17

Chapter 13: Veterinary Package Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-1 Principles of Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-3 The Animal Catalog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-3 Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-5 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-5 Precision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-5 Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-6 Linearity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-7 Carryover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-7 Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-8 Operating Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-9 Vet Package Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-10 Routine Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-21 Run Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-21 Selecting the Animal . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-22

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Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-27 Procedure: MCV or MPV Calibration . . . . . . . . . . . . . . . 13-28 Pre-Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . 13-28 Determining the Calibration Factors for MCV and MPV 13-29 Entering the Calibration Factor . . . . . . . . . . . . . . . . . . . 13-29 Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-31 Adding New Animal Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-33 Adding a New Configuration File . . . . . . . . . . . . . . . . . . 13-34 Customizing the Display . . . . . . . . . . . . . . . . . . . . . . . . 13-36 Turning on the Gains Template . . . . . . . . . . . . . . . . . . . 13-37 Preparing the Samples . . . . . . . . . . . . . . . . . . . . . . . . . . 13-38 Running the Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-38 Determining the Variance . . . . . . . . . . . . . . . . . . . . . . . 13-39 Baso Box Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-46 Vet Package Suggestions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-49 Examples of Customer-Defined Default Codes . . . . . . . 13-50 Turning The Vet Package Off . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-53 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-55

Chapter 14: Reticulocyte Package Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-1 Principles of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-7 Retic Menu Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-9 Turning the Reticulocyte Package ON and OFF . . . . . . . 14-10 Retic Main Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-14 Retic Set Up Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-16 Retic Data Log Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-30 Data Review from the Retic Data Log . . . . . . . . . . . . . . 14-37 Retic QC Log Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-39 Retic Diagnostics Menu . . . . . . . . . . . . . . . . . . . . . . . . . 14-47 Retic Special Protocols Menu . . . . . . . . . . . . . . . . . . . . . 14-52 Routine Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-55 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-55 Retic Run Menu Flowchart . . . . . . . . . . . . . . . . . . . . . . . 14-56 Retic Run Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-57 Reticulocyte Specimens . . . . . . . . . . . . . . . . . . . . . . . . . 14-67 Quality Control Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-77 Control Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-77 Mixing and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-78 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-79 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-79 Operational Messages and Data Flagging . . . . . . . . . . . . 14-79 High Background Counts . . . . . . . . . . . . . . . . . . . . . . . . 14-82 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-83

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Master Table of Contents

Bibliography Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Bibliography-1

Appendix A: Bar Codes Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix A-1 Bar Coding Function . . . . . . . . . . . . . . . . . . . . . . Appendix A-1 Understanding the Label Code . . . . . . . . . . . . . . Appendix A-2 Bar Code Types and Characteristics . . . . . . . . . . Appendix A-3 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix A-5 Bar Code Label Formats . . . . . . . . . . . . . . . . . . . . Appendix A-5 Bar Code Check Digit Formats . . . . . . . . . . . . . . Appendix A-5 Bar Code Label Specifications . . . . . . . . . . . . . . . Appendix A-6 CELL-DYN Bar Code Labels . . . . . . . . . . . . . . . . . Appendix A-7 CELL-DYN Q Labels . . . . . . . . . . . . . . . . . . . . . . . Appendix A-7 Bar Code Label Placement . . . . . . . . . . . . . . . . . . Appendix A-8 Acknowledgment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix A-9

Appendix B: Parts List Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix B-1 CELL-DYN 3700 Accessories . . . . . . . . . . . . . . . . Appendix B-1

Appendix C Appendix C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix C-1

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List of Figures

List of Figures Figure 1.1: CELL-DYN 3700SL System. . . . . . . . . . . . . . . . . . . . 1-1 Figure 1.2: CELL-DYN 3700 System . . . . . . . . . . . . . . . . . . . . . 1-5 Figure 1.3: CELL-DYN 3700CS System Analyzer Front View . . 1-6 Figure 1.4: Analyzer Flow Panel Components . . . . . . . . . . . . . 1-9 Figure 1.5: Analyzer Left Side Panel Components . . . . . . . . . 1-14 Figure 1.6: Analyzer Rear Panel Components . . . . . . . . . . . . . 1-17 Figure 1.7: Power Supply Module Voltage Switch Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18 Figure 1.8: Data Station — Front View. . . . . . . . . . . . . . . . . . . 1-19 Figure 1.9: Data Station — Rear Components . . . . . . . . . . . . . 1-21 Figure 1.10: Control Button – Front View . . . . . . . . . . . . . . . . 1-23 Figure 1.11: Inputs Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . 1-25 Figure 1.12: Caution Label . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-28 Figure 2.1: Data Station Rear Components . . . . . . . . . . . . . . . . 2-8 Figure 2.2: CELL-DYN 3700SL . . . . . . . . . . . . . . . . . . . . . . . . . 2-12 Figure 2.3: Tube Rack Showing Label Placement Locations. . 2-13 Figure 2.4: Left Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16 Figure 2.5: Front Flow Panel . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18 Figure 3.1: Volumetric Metering . . . . . . . . . . . . . . . . . . . . . . . Figure 3.2: WOC Flow Cell . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 3.3: WBC Light Scatter . . . . . . . . . . . . . . . . . . . . . . . . . Figure 3.4: Optical Bench Assembly . . . . . . . . . . . . . . . . . . . . Figure 3.5: Mononuclear-Polymorphonuclear Scatter . . . . . . Figure 3.6: Neutrophil-Eosinophil Scatter. . . . . . . . . . . . . . . . Figure 3.7: Mononuclear Scatter . . . . . . . . . . . . . . . . . . . . . . . Figure 3.8: WBC Histograms . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 3.9: WBC Data and Scatterplots . . . . . . . . . . . . . . . . . . Figure 3.10: Volumetric Metering . . . . . . . . . . . . . . . . . . . . . . Figure 3.11: RBC Data and Histogram. . . . . . . . . . . . . . . . . . . Figure 3.12: PLT Data and Histogram . . . . . . . . . . . . . . . . . . . Figure 3.13: Flagging Diagnostics Screen . . . . . . . . . . . . . . . . Figure 3.14: Scatterplot with Increased Stroma in the N1 Region . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3-11 3-14 3-15 3-17 3-20 3-21 3-22 3-24 3-25 3-28 3-30 3-33 3-41 3-43

Figure 5.1: Data Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2 Figure 5.2: Main Menu Screen. . . . . . . . . . . . . . . . . . . . . . . . . . 5-3 Figure 5.3: Set Up Menu Screen . . . . . . . . . . . . . . . . . . . . . . . 5-13 Figure 5.4: Date/Time Set Up Screen. . . . . . . . . . . . . . . . . . . . 5-14 Figure 5.5: Patient Limit Set Screen. . . . . . . . . . . . . . . . . . . . . 5-16 Figure 5.6: Diluent Log Screen . . . . . . . . . . . . . . . . . . . . . . . . 5-19

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List of Figures

Figure 5.7: QC Set Up Menu Screen . . . . . . . . . . . . . . . . . . . . 5-21 Figure 5.8: QC File Set Up (Lot Number Entry) Screen . . . . . 5-22 Figure 5.9: QC File Set Up (Replicate ID Entry) Screen . . . . . 5-23 Figure 5.10: QC Range Entry Screen . . . . . . . . . . . . . . . . . . . . 5-27 Figure 5.11: QC Means/Limits Entry Screen . . . . . . . . . . . . . . 5-28 Figure 5.12: QC Means/Limits Entry Screen Showing the Update From File Key . . . . . . . . . . . . . . . . . . . . . . . . . . 5-30 Figure 5.13: Customize QC Display Screen. . . . . . . . . . . . . . . 5-32 Figure 5.14: Customize QC Display Screen Showing Standard Groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-35 Figure 5.15: Customize QC Printout Screen . . . . . . . . . . . . . . 5-37 Figure 5.16: X-B Set Up Screen . . . . . . . . . . . . . . . . . . . . . . . . 5-40 Figure 5.17: Operation Set Up Menu Screen. . . . . . . . . . . . . . 5-43 Figure 5.18: Bar Code Set Up Screen . . . . . . . . . . . . . . . . . . . . 5-44 Figure 5.19: Computer Set Up Screen . . . . . . . . . . . . . . . . . . . 5-46 Figure 5.20: Units Selection Screen . . . . . . . . . . . . . . . . . . . . . 5-49 Figure 5.21: Customize Displayed Report Screen . . . . . . . . . . 5-52 Figure 5.22: Customize Printed Report Screen for Pre-Printed Tickets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-56 Figure 5.23: Customize Printed Report Screen for Blank Tickets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-58 Figure 5.24: Customize Printed Report Screen for the Graphics Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-61 Figure 5.25: Customize Printout Header Screen for the Graphics Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-64 Figure 5.26: Run Screen for Patient Samples . . . . . . . . . . . . . 5-68 Figure 5.27: Run Screen for Auxiliary Samples . . . . . . . . . . . . 5-70 Figure 5.28: Run Screen Showing Count Times and Flagging Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-73 Figure 5.29: Run Screen Showing Flagging Messages, RBC CLOG Message, and RBC Up Time . . . . . . . . . . . . . . . 5-73 Figure 5.30: Run Screen Showing Bulletin Line Message . . . . 5-74 Figure 5.31: Work List Screen . . . . . . . . . . . . . . . . . . . . . . . . . 5-75 Figure 5.32: Specimen Type Screen. . . . . . . . . . . . . . . . . . . . . 5-77 Figure 5.33: Run Screen for Patient Samples . . . . . . . . . . . . . 5-78 Figure 5.34: Run Screen for a QC File . . . . . . . . . . . . . . . . . . . 5-79 Figure 5.35: Run Screen for Background Counts . . . . . . . . . . 5-80 Figure 5.36: Run Screen for Electrical Background Counts . . 5-81 Figure 5.37: Run Screen for Resistant RBC Specimen Type . . 5-82 Figure 5.38: Auxiliary Specimen Type Screen . . . . . . . . . . . . . 5-83 Figure 5.39: Run Screen for the Auxiliary Specimen Type . . . 5-85 Figure 5.40: Work List Screen . . . . . . . . . . . . . . . . . . . . . . . . 5-104 Figure 5.41: Work List Set Up Screen . . . . . . . . . . . . . . . . . . 5-108 Figure 5.42: Data Log Screen . . . . . . . . . . . . . . . . . . . . . . . . . 5-121 Figure 5.43: Display Specimen Screen . . . . . . . . . . . . . . . . . 5-124 Figure 5.44: Data Log Search Screen . . . . . . . . . . . . . . . . . . . 5-126 Figure 5.45: Data Log Screen Showing Reject From X-B Key 5-127

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List of Figures

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

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

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

6-14 6-15 6-16 6-18 6-19 6-20 6-22 6-23 6-24 6-25 6-26

Figure 7.1: QC Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3 Figure 7.2: The X-B RBC Data Screen . . . . . . . . . . . . . . . . . . . . 7-4 Figure 7.3: The X-B RBC Graphs Screen . . . . . . . . . . . . . . . . . . 7-5 Figure 7.4: The X-B WBC Data Screen. . . . . . . . . . . . . . . . . . . . 7-6 Figure 7.5: The X-B WBC Graphs Screen. . . . . . . . . . . . . . . . . . 7-7 Figure 7.6: The View QC Log Screen . . . . . . . . . . . . . . . . . . . . . 7-8 Figure 7.7: The Levey-Jennings Menu Screen . . . . . . . . . . . . . 7-11 Figure 7.8: QC Log Screen With Rejected Results. . . . . . . . . . 7-12 Figure 7.9: Levey-Jennings Menu Screen Showing Westgard Rule Violations . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-18 Figure 8.1: Laser Hazard Label. . . . . . . . . . . . . . . . . . . . . . . . . . 8-8 Figure 8.2: Laser Aperture and Warning Label Position Protective Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8 Figure 8.3: Laser Warning Label Position - Flow Panel. . . . . . . 8-9 Figure 8.4: Class 2 Laser Caution Label. . . . . . . . . . . . . . . . . . . 8-9 Figure 8.5: Class 2 Laser Caution Label Location . . . . . . . . . . . 8-9 Figure 8.6: Laser Label, Rear Panel . . . . . . . . . . . . . . . . . . . . . 8-10 Figure 8.7: Class 1 Laser Product Label Location . . . . . . . . . . 8-10

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Master Table of Contents-13

List of Figures

Figure 9.1: Analyzer Flow Panel Components . . . . . . . . . . . . . 9-3 Figure 9.2: Special Protocols Screen . . . . . . . . . . . . . . . . . . . . . 9-5 Figure 9.3: Reagent Reservoir Screen . . . . . . . . . . . . . . . . . . . . 9-7 Figure 9.4: Special Protocols Screen 2. . . . . . . . . . . . . . . . . . . . 9-9 Figure 9.5: Maintenance Log Screen . . . . . . . . . . . . . . . . . . . . 9-13 Figure 9.6: Interval Set Up Screen . . . . . . . . . . . . . . . . . . . . . . 9-15 Figure 9.7: Update Maintenance Log Screen. . . . . . . . . . . . . . 9-16 Figure 9.8: Special Protocols: Auto-Clean Screen . . . . . . . . . . 9-19 Figure 9.9: Shear Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-23 Figure 9.10: Sample Aspiration Peristaltic Pump . . . . . . . . . . 9-26 Figure 9.11: WOC Syringes and Syringe Assembly . . . . . . . . . 9-29 Figure 9.12: Analyzer Left Side Panel . . . . . . . . . . . . . . . . . . . 9-32 Figure 9.13: WOC Transfer Peristaltic Pump . . . . . . . . . . . . . 9-33 Figure 9.14: Special Protocols: Extended Auto-Clean Screen . 9-35 Figure 9.15: von Behrens Transducer Assembly . . . . . . . . . . . 9-40 Figure 9.16: Transducer Assembly and Aperture Plate . . . . . . 9-41 Figure 9.17: The von Behrens WIC Transducer, HGB Flow Cell, and Solenoid 13 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-43 Figure 9.18: Open Sample Aspiration Probe . . . . . . . . . . . . . . 9-45 Figure 9.19: Flow Panel Open/Closed Mode Tubing . . . . . . . 9-48 Figure 9.20: Closed Sampler Module . . . . . . . . . . . . . . . . . . . 9-51 Figure 9.21: Analyzer Flow Panel: Accessing Normally Closed Valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-52 Figure 10.1: First Diagnostics Menu Screen . . . . . . . . . . . . . . 10-5 Figure 10.2: Operator Correctable Fault Report Screen . . . . . 10-6 Figure 10.3: Fatal Fault Report Screen. . . . . . . . . . . . . . . . . . . 10-7 Figure 10.4: Fault Report — No Fault Pending Screen. . . . . . . 10-7 Figure 10.5: Count Rate Summary Screen. . . . . . . . . . . . . . . . 10-8 Figure 10.6: WOC Count Rate Data (Tabular Format) . . . . . . 10-9 Figure 10.7: WOC Count Rate Graph . . . . . . . . . . . . . . . . . . 10-10 Figure 10.8: Raw Data Summary Screen . . . . . . . . . . . . . . . . 10-11 Figure 10.9: Second Diagnostics Menu Screen . . . . . . . . . . . 10-12 Figure 10.10: Pump Operation Screen . . . . . . . . . . . . . . . . . 10-13 Figure 10.11: Pump Operation Screen — Vacuum ON . . . . . 10-14 Figure 10.12: Inhibit Pumps Screen . . . . . . . . . . . . . . . . . . . 10-15 Figure 10.13: Vacuum Test Screen . . . . . . . . . . . . . . . . . . . . 10-16 Figure 10.14: Drain Accumulators Screen . . . . . . . . . . . . . . . 10-17 Figure 10.15: Third Diagnostics Menu Screen . . . . . . . . . . . 10-18 Figure 10.16: Voltage Readings Screen . . . . . . . . . . . . . . . . . 10-19 Figure 10.17: Fourth Diagnostics Menu Screen . . . . . . . . . . 10-20 Figure 10.18: Fifth Diagnostics Menu Screen (CELL-DYN 3700SL System) . . . . . . . . . . . . . . . . . . . . . . . 10-21 Figure 10.19: Auto-Sampler Version Screen . . . . . . . . . . . . . 10-22 Figure 10.20: Serial Test Screen. . . . . . . . . . . . . . . . . . . . . . . 10-23 Figure 10.21: Serial Test Transmit Message Screen Transmit Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-25

Master Table of Contents-14

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List of Figures

Figure 10.22: Sample Loader Vent/Aspiration Needle Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-33 Figure 10.23: Sample Loader Vent/Aspiration Needle — Tubing Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-34 Figure 10.24: Volumetric Metering . . . . . . . . . . . . . . . . . . . . 10-50 Figure 12.1: Analyzer with Sample Loader . . . . . . . . . . . . . . . 12-1 Figure 12.2: Rack Movement - Top View . . . . . . . . . . . . . . . . 12-2 Figure 12.3: Tube Labeling Requirements. . . . . . . . . . . . . . . . 12-3 Figure 12.4: Sample Loader . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5 Figure 12.5: Operation Keyboard . . . . . . . . . . . . . . . . . . . . . . 12-6 Figure 12.6: Tower Stations . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-7 Figure 12.7: Tube Racks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-10 Figure 13.1: Operation Set Up Menu Screen. . . . . . . . . . . . . . 13-9 Figure 13.2: Set Up Menu Screen . . . . . . . . . . . . . . . . . . . . . 13-11 Figure 13.3: Animal Type Set Up Screen . . . . . . . . . . . . . . . . 13-12 Figure 13.4: View Animal Type Set Up Screen . . . . . . . . . . . 13-13 Figure 13.5: Animal Limit Set 1. . . . . . . . . . . . . . . . . . . . . . . 13-14 Figure 13.6: Animal Type Catalog Screen . . . . . . . . . . . . . . . 13-16 Figure 13.7: Catalog Contents, Animal Type Set Up Screen . 13-17 Figure 13.8: Expected Ranges . . . . . . . . . . . . . . . . . . . . . . . . 13-18 Figure 13.9: Run Screen for Animals . . . . . . . . . . . . . . . . . . . 13-21 Figure 13.10: Animal Type Selection Screen . . . . . . . . . . . . . 13-22 Figure 13.11: Specimen Type Screen. . . . . . . . . . . . . . . . . . . 13-23 Figure 13.12: Dog Background Count. . . . . . . . . . . . . . . . . . 13-24 Figure 13.13: Enter Calibration Factor Screen . . . . . . . . . . . 13-28 Figure 13.14: Add New Animal Type Screen . . . . . . . . . . . . . 13-34 Figure 13.15: Customized Display for Adding New Animals 13-36 Figure 13.16: Gains Template . . . . . . . . . . . . . . . . . . . . . . . . 13-37 Figure 13.17: Target Locations for the Neutrophil and Lymphocyte populations . . . . . . . . . . . . . . . . . . . . . . . . . 13-39 Figure 13.18: Set Point Entry Screen . . . . . . . . . . . . . . . . . . . 13-44 Figure 13.19: Baso Box Set Up. . . . . . . . . . . . . . . . . . . . . . . . 13-46 Figure 14.1: Operation Set Up Menu Screen with Reticulocyte Package Disabled . . . . . . . . . . . . . . . . . . . . . . Figure 14.2: Operation Set Up Menu Screen with Reticulocyte Package Enabled. . . . . . . . . . . . . . . . . . . . . . Figure 14.3: Reticulocyte Main Menu Screen . . . . . . . . . . . . Figure 14.4: Reticulocyte Set Up Screen . . . . . . . . . . . . . . . . Figure 14.5: Reticulocyte Patient Limits Screen . . . . . . . . . . Figure 14.6: Reticulocyte QC Set Up Screen . . . . . . . . . . . . . Figure 14.7: Retic QC Range Entry Screen . . . . . . . . . . . . . . Figure 14.8: Retic QC Means/Limits Screen . . . . . . . . . . . . . Figure 14.9: Retic Set Up QC Screen . . . . . . . . . . . . . . . . . . .

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

Master Table of Contents-15

List of Figures

Figure 14.10: Operation Set Up Menu Screen with Reticulocyte Package Enabled. . . . . . . . . . . . . . . . . . . . . . 14-27 Figure 14.11: Reticulocyte Units Selection Screen . . . . . . . . 14-28 Figure 14.12: Reticulocyte Data Log Screen . . . . . . . . . . . . . 14-31 Figure 14.13: Reticulocyte Display Specimen Screen . . . . . . 14-33 Figure 14.14: Reticulocyte Data Log Search Screen . . . . . . . 14-35 Figure 14.15: Reticulocyte Data Log Screen Showing the Starting Reticulocyte Sequence Number Field . . . . . . . . . 14-36 Figure 14.16: Reticulocyte Display Specimen Screen . . . . . . 14-37 Figure 14.17: Reticulocyte QC Log Screen . . . . . . . . . . . . . . 14-39 Figure 14.18: View Reticulocyte QC Log Screen . . . . . . . . . . 14-41 Figure 14.19: The Reticulocyte Levey-Jennings Screen. . . . . 14-44 Figure 14.20: View Reticulocyte QC Log Screen with Rejected Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-45 Figure 14.21: Reticulocyte Diagnostics Screen . . . . . . . . . . . 14-48 Figure 14.22: Reticulocyte Count Rate Summary Screen (Tabular Format) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-49 Figure 14.23: Reticulocyte Count Rate Summary Screen (Graphic Format) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-50 Figure 14.24: Reticulocyte Raw Data Summary Screen . . . . 14-51 Figure 14.25: Reticulocyte Special Protocols Screen. . . . . . . 14-53 Figure 14.26: Reticulocyte Run Screen . . . . . . . . . . . . . . . . . 14-57 Figure 14.27: The First Reticulocyte Patient Specimen Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-58 Figure 14.28: The Second Reticulocyte Patient Specimen Screen (Displayed When the Specimen ID is Found) . . . 14-59 Figure 14.29: The Third Reticulocyte Patient Specimen Screen (Displayed When the Specimen ID Found is More Than Eight Hours Old) . . . . . . . . . . . . . . . . . . . . . . 14-60 Figure 14.30: The Fourth Reticulocyte Patient Specimen Screen (Displayed When the Specimen ID Is Not Found) 14-61 Figure 14.31: The Reticulocyte Run Result Screen for a Patient Specimen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-62 Figure 14.32: Reticulocyte Run Result Screen for a QC Specimen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-65 Figure 14.33: Reticulocyte Run Result Screen for a Background Specimen . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-66 Figure A.1: Bar Code Label Specifications . . . . . . . . . Appendix A-6 Figure A.2: Tube Labeling Requirements . . . . . . . . . Appendix A-8

Master Table of Contents-16

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List of Tables

List of Tables Table 3.1: Parameter Flagging Messages . . . . . . . . . . . . . . . . . 3-39 Table 4.1: Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3 Table 4.2: Power Specifications . . . . . . . . . . . . . . . . . . . . . . . . . 4-4 Table 4.3: Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9 Table 4.4: Power Specifications . . . . . . . . . . . . . . . . . . . . . . . . 4-10 Table 4.5: Precision of the Hemogram and Reticulocyte Parameters (N = 31) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16 Table 4.6: Precision of the WBC Differential Parameters . . . . 4-16 Table 4.7: Linearity Specifications . . . . . . . . . . . . . . . . . . . . . 4-17 Table 4.8: Accuracy of Hemogram Parameters . . . . . . . . . . . . 4-18 Table 4.9: Accuracy of WBC Differential Parameters . . . . . . . 4-19 Table 4.10: Carryover for WBC, RBC, HGB, PLT and Retics . . 4-19 Table 4.11: Typical Precision for Hemogram Parameters. . . . 4-20 Table 4.12: Reference Range for Distributional Flagging . . . . 4-21 Table 4.13: Reference Range for Morphologic Flagging . . . . . 4-21 Table 4.14: Abnormalities Evaluated. . . . . . . . . . . . . . . . . . . . 4-22 Table 4.15: Flagging Analysis Truth Table . . . . . . . . . . . . . . . 4-23 Table 4.16: Analysis of False Negative Results . . . . . . . . . . . . 4-23 Table 5.1: Report Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-50 Table 6.1: Calibration Criteria. . . . . . . . . . . . . . . . . . . . . . . . . Table 6.2: Calibration Criteria. . . . . . . . . . . . . . . . . . . . . . . . . Table 6.3: Calibration Criteria. . . . . . . . . . . . . . . . . . . . . . . . . Table 6.4: Mode to Mode Calibration Criteria . . . . . . . . . . . . Table 6.5: Mode to Mode Calibration Criteria . . . . . . . . . . . .

6-41 6-51 6-63 6-78 6-87

Table 7.1: Troubleshooting X-B RBC. . . . . . . . . . . . . . . . . . . . 7-23 Table 7.2: Default (Preset) X-B WBC Values . . . . . . . . . . . . . . 7-25 Table 13.1: Precision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Table 13.2: Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Table 13.3: Linearity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Table 13.4: Carryover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

13-5 13-6 13-7 13-7

Table 14.1: Potential Interfering Substances. . . . . . . . . . . . . 14-69 Table B.1: CELL-DYN 3700 Accessories Kit (List Number 06H88-01) . . . . . . . . . . . . . . . . . . . . . Appendix B-1 Table B.2: CELL-DYN 3700 Sample Loader Accessories Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix B-2 Table B.3: CELL-DYN 3700 Optional Accessories . . . Appendix B-3 Table B.4: CELL-DYN 3700 Calibrators and Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix B-4 Table B.5: CELL-DYN 3700 Reagents. . . . . . . . . . . . . Appendix B-4 CELL-DYN® 3700 Operator’s Manual

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Master Table of Contents-17

List of Tables

NOTES

Master Table of Contents-18

CELL-DYN® 3700 Operator’s Manual

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Foreword

Introduction

We welcome you to the role of Operator of a CELL-DYN 3700 System. Your system, which includes state-of-the-art technology, is designed to function consistently and dependably from day to day. The CELL-DYN 3700 System is backed by dedicated professionals who excel in engineering, medical technology, training, and service. As part of the customer training program, we will teach you to operate, maintain and troubleshoot your System. Abbott Laboratories is dedicated to manufacturing the highest quality, most reliable instrumentation available. We look forward to serving your needs in any way possible.

Customer Service United States: 1 (877) 4ABBOTT or 1 (877) 422-2688 Abbott Diagnostics Division Customer Service 200 Abbott Park Road Abbott Park, IL 60064, USA Canada: 1 (800) 387-8378 For customers outside the US, call your local Customer Service Representative.

Intended Use The CELL-DYN 3700 System is a multiparameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories.

Proprietary Statement The entire contents are copyright 2000, 2003, 2004, and 2007 by Abbott Laboratories. Abbott Laboratories’ software programs are protected by copyright. All rights are reserved. This software was developed solely for use with Abbott Laboratories’ equipment and for in vitro diagnostic applications as specified in the operating instructions. No part of this document may be reproduced, stored, or transmitted in any form or by any means (electronic, mechanical, photocopied, recorded, or otherwise) without the prior written permission of Abbott Laboratories.

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Patent Statement The CELL-DYN 3700 instrument system is covered by one or more of the following US Patents: 4,710,021; 4,726,237; 5,378,633; 5,510,267; 5,733,784; 5,017,497; 5,958,781; and 6,740,527.

Instrument Disclaimer All operating instructions must be followed. In no event shall Abbott be responsible for failures, errors, or other liabilities resulting from customers’ noncompliance with the procedures and precautions outlined herein. Abbott has designed the CELL-DYN 3700 System components for optimal performance. Substitution of reagents, calibrators, controls, and components manufactured by other companies may adversely affect the performance of the Analyzer.

Pictorial Disclaimer All samples (printouts, graphics, displays or screens, etc.) are for information and illustration purposes only and shall not be used for clinical or maintenance evaluations.

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CELL-DYN® 3700 System Operator’s Manual

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Abbott Instrument Warranty For US Customers Only Abbott Laboratories warrants CELL-DYN 3000 Series Analyzers, sold by Abbott Sales Representatives, to be free from defects in workmanship and materials during normal use by the original purchaser excluding items subject to wear and tear and which require replacement during normal use as a matter of course. This warranty shall continue for a period of one (1) year, commencing twenty-one (21) days from the date of shipment to the original purchaser or until title is transferred from the original purchaser, whichever occurs first (the “Warranty Period”). If any defects occur during the Warranty Period, contact Abbott Diagnostics Customer Service immediately and be prepared to furnish pertinent details concerning the defect, the model number, and the serial number. Warranty support is provided twenty-four (24) hours a day, seven (7) days a week for all CELL-DYN 3000 Series customers. This Warranty does not cover defects or malfunctions which: 1. Are not reported to Abbott during the Warranty Period and within one week of occurrence. 2. Result from chemical decomposition or corrosion. 3. Are caused by customer or third-party abuse, misuse, or negligence, or by failure to comply with any requirement or instruction contained in the applicable Abbott Operator’s Manual. 4. Result from maintenance, repair, or modification performed without Abbott’s authorization. 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. THE FOREGOING IS THE SOLE WARRANTY MADE BY ABBOTT REGARDING THE INSTRUMENT; AND ABBOTT SPECIFICALLY DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY AND OF FITNESS FOR A PARTICULAR PURPOSE. CELL-DYN 3700 Hematology Systems are manufactured by Abbott Diagnostics Division, Abbott Laboratories, 200 Abbott Park Road, Abbott Park, IL 60064, USA. Please direct all inquiries concerning information in this manual to the foregoing address. CELL-DYN® 3700 System Operator’s Manual

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Safety Agency Approvals In Vitro Diagnostic Directive

98/79/EC

Legal Manufacturer

Abbott Laboratories Abbott Park, Il 60064 USA

Authorized Representative

ABBOTT Max-Planck-Ring 2 65205 Wiesbaden, Germany

UL 61010A-1

Approved

CSA C22.2 No. 1010.1 Approved IEC 1010-1

Approved

Trademark Statements CELL-DYN, and CELL-DYN HemCal are registered trademarks of Abbott Laboratories. MAPSS is a trademark of Abbott Laboratories. CONTRAVES, COULTER, EPSON, EPSON STYLUS, HEMOGARD, Luer-Lok, MICROLINE, OKIDATA, PLEXIGLAS, TEFLON, TYGON, VACUTAINER, and Westgard are not trademarks of Abbott Laboratories.

Symbols The symbols listed below are used on CELL-DYN labeling, including the instrument, reagents, calibrators, controls, and this manual. Please note that Warning and Caution symbols and statements are in this manual in Chapter 8: Hazards. General Instrument Symbols Alternating Current Input Protective Conductor (Ground) Terminal Off ON

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CELL-DYN® 3700 System Operator’s Manual

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Specific Instrument Symbols AC INPUT ALARM AUTO LOADER AUTO SAMPLER

Alternating Current Input Alarm Auto Loader Auto Sampler

MODEL MONITOR PAUSE PERISTALTIC PUMP

BUSY

Busy

COM 1

Communications Port 1

RBC METERING

COM 2

Communications Port 2

RBC TRANSDUCER

DATA STATION

Data Station

POWER

Model Number Monitor Pause Peristaltic Pump Power RBC Metering Assembly RBC Transducer Assembly

READY

Ready

E/STOP

Emergency Stop

REPEAT

Repeat

FAULT

Fault

RESET

Reset

FREQUENCY FUSES HDD HGB FLOWCELL HSSL INIT INSTALLATION DISK KEYBOARD LINE FREQ SELECT LINE VOLTAGE SELECT

Frequency Fuses Hard Disk Drive Hemoglobin Flowcell High Speed Serial Link Initialize Installation Disk Keyboard

REV RS232

Revision Recommended Specification 232

SERVICE DISK

Service Disk

SET-UP DISK

Set-up Disk

SN SOL START TEST INTERFACE

Serial Number Solenoid Start Test Interface

Line Frequency Select

TOUCH

Touch

Line Voltage Select

WASTE

Waste

LPT1

First Parallel Printer Port

WASTE CHAMBER 1

Waste Chamber 1

LPT2

Second Parallel Printer Port

WASTE CHAMBER 2

Waste Chamber 2

MAN

Manual Mode

WASTE SENSOR

Waste Sensor

Maximum Power

WIC METERING

WBC Impedance Count Metering Assembly

MAX POWER MIXING CHAMBER

Mixing Chamber

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WIC TRANSDUCER

WBC Impedance Count Transducer Assembly

v

Reagent related Cyanide-Free Hemoglobin/WBC Impedance Count Lyse Reagent

CN-FREE HGB/WIC LYSE

Detergent Reagent

DETERGENT

Diluent Reagent

DILUENT ENZYMATIC CLEANER CONCENTRATE

Enzymatic Cleaner Concentrate Hemoglobin

HGB HGB LYSE HGB/WIC LYSE

Hemoglobin Lyse Reagent Hemoglobin/WBC Impedance Count Lyse Lot Number

LOT SHEATH 8oC

Sheath Reagent Storage temperature. (Example shows “Store at 2º–8ºC”)

2 oC

Use by / Expiration Date WBC LYSE

WBC Lyse Reagent

Calibrator/Control related ASSAY VALUE CONTROL CONTROL ASSAY CONTROL L N H

Control Control Assay Disk Control, Tri-Level

CONTROL L

Control, Low

CONTROL N

Control, Normal

CONTROL H

Control, High

CONTROL I

Control, Level I

CONTROL II

Control, Level II

MEAN RANGE

Mean Range

MEAN VALUE

Mean Value

PARAMETER

Parameter

RETIC CONTROL

vi

Assay Value

Reticulocyte Control CELL-DYN® 3700 System Operator’s Manual

9140320F — April 2007

Calibrator/Control related SYSTEM

System

WB CONTROL L

Whole Blood Control, Low

WB CONTROL N

Whole Blood Control, Normal

WB CONTROL H

Whole Blood Control, High

WB CONTROL TRI-LEVEL WB CAL WB CONTROL

Whole Blood Control, Tri-Level Whole Blood Calibrator Whole Blood Control

Miscellaneous Legal Manufacturer Manufacturer

Consult instructions for use

Date of Manufacture

EC REP

Authorized Representative

IVD

For In Vitro Diagnostic Use

REF

List Number Separate collection for electrical and electronic equipment waste per Directive 2002/96/EC in the European Union

CELL-DYN® 3700 System Operator’s Manual

9140320F — April 2007

vii

Instrument Labeling The following labels are affixed to the CELL-DYN 3700 System: Current CELL-DYN customer’s instruments are CE Marked to the European Electro-Magnetic Compliance (EMC) and Low-Voltage Directives and have the following labels: DANGER GEFAHR DANGER PELIGRO PERICOLO LASER LIGHT WHEN OPEN. BEI OFFENER ABDECKUNG TRITT LASERSTRAHL AUS. RAYON LASER SI OUVERT. RADIACION LASER SI SE ABRE. LUCE LASER SE APERTO. AVOID DIRECT EXPOSURE TO BEAM. NICHT DIREKT IN DEN LASERSTRAHL BLICKEN. EVITER TOUTE EXPOSITION DIRECTE AU FAISCEAU LASER. NO SE EXPONGA DIRECTAMENTE AL RAYO LASER. EVITARE OGNI ESPOSIZIONE DIRETTA AL RAGGIO. PN 9230701D

Laser Label, Front Panel

Class l Laser Product per lEC 825-1[1993] PN 9230702A

Laser Label, Rear Panel

ABBOTT DIAGNOSTICS A wholly owned subsidiary of Abbott Laboratories Abbott Park IL. 60064

THIS PRODUCT CONFORMS TO THE APPLICABLE REQUIREMENTS OF 21 CFR SUBCHAPTER J AT THE DATE OF MANUFACTURE MANUFACTURED DATE MODEL NO. SERIAL NO. LIST NO. MADE IN U.S.A.

REV PN 9230308 REV E

Serial Number Label, Rear Panel viii

CELL-DYN® 3700 System Operator’s Manual

9140320E — September 2004

WARNING: SET FOR 120 VOLTS When operation at other line voltage is required, refer to operation manual for detailed instructions. WARNUNG: FUER 120 VOLT EINGESTELLT Ist der Betrieb mit einer anderen Netzspannung erforderlich, entnehmen Sie die genauen Anweisungen der Bedienungsanleitung. MISE EN GARDE : PARAMETRE POUR UTILISATION SUR 120 VOLTS Si une utilisation à une tension de réseau différente est requise, reportez-vous au Manuel Technique pour de plus amples informations. ADVERTENCIA: CONFIGURADO PARA 120 VOLTIOS Si se necesita otra tensión diferente a la indicada, consulte el Manual de Operaciones para instrucciones más detalladas. AVVERTENZA: CONFIGURATO PER 120 VOLT Se la tensione è di voltaggio diverso, fare riferimento alle istruzioni dettagliate nel Manuale di Impiego. PN 9230003

Voltage Label, Rear Panel

CE Label

CAUTION: DO NOT HANDLE SOLUTION CONTAINER UNLESS PROPERLY PROTECTED. REFER TO OPERATOR’S MANUAL FOR INSTALLATION PROCEDURE. PN 9230334

Solution Container Label, Rear Panel

CELL-DYN® 3700 System Operator’s Manual

9140320E — September 2004

ix

New CELL-DYN customer’s instruments are CE Marked to the European In Vitro Diagnostic Directive, which encompasses the requirements of the EMC and Safety Directives, and have the following labels:

CAUTION – CLASS 3B LASER LIGHT WHEN OPEN. AVOID EXPOSURE TO BEAM. PN 9230701

Laser Label, Front Panel

CLASS 1 LASER PRODUCT PN 9230702

Laser Label, Rear Panel

ABBOTT DIAGNOSTICS DIVISION Abbott Laboratories Abbott Park IL, 60064 USA

THIS PRODUCT CONFORMS TO THE APPLICABLE REQUIREMENTS OF 21 CFR SUBCHAPTER J AT THE DATE OF MANUFACTURE DATE OF MANUFACTURE

MADE IN U.S.A.

PN 9230308 REV G

Serial Number Label, Rear Panel

Biological Risk PN 9231446

Biological Risk Label, Touch Plate x

CELL-DYN® 3700 System Operator’s Manual

9140320F — April 2007

ABBOTT LABORATORIES Abbott Park, IL 60064 USA

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

PN 9230751A

CE Mark Label, Rear Panel

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

AVVERTENZA: CONFIGURATO A 120 VOLT / AVISO: CONFIGURADO PARA 120 VOLTS / ADVARSEL: KONFIGURERET TIL 120 V / VARNING: INSTLLD FR 120 VOLT / ΠΡΟΕΙΔΟΠΟΙΗΣΗ: ΧΡΗΣΗ ΣΤΑ 120 VOLTS

Consult instructions for use if different voltage is required. / Ist der Betrieb mit einer anderen Netzspannung erforderlich, in der Bedienungsanleitung nachlesen. / Si une utilisation  une tension diffrente est requise, consulter les instructions d’utilisation. / Consulte las instrucciones de uso si la tensin es distinta. / Per un voltaggio diverso, consultare le istruzioni per l’uso. / Se for necessria uma voltagem diferente, consultar as instru es de utiliza o. / Se brugermanualen, hvis der er behov for drift med en anden netsp nding. / L s tillhrande dokumentation om en annan sp nning behvs. / Για χρήση σε άλλη τάση ρεύματος, συμβουλευτείτε τις οδηγίες χρήσης. PN 9230003F

Voltage Label, Rear Panel

CAUTION: Do not handle Solution Container unless properly protected. VORSICHT: Die Reagenzbeh

lter nur ordnungsgem  gesichert bewegen.

ATTENTION : Ne pas manipuler le flacon de solution sans protection

approprie. PRECAUCIN: no maneje el recipiente de la solucin a menos que est protegido adecuadamente. ATTENZIONE: Non maneggiare il recipiente della soluzione se non si  protetti in modo adeguato. ATENO: n o manipular o recipiente da solu o sem estar devidamente protegido. VIGTIGT: Beholderen med oplsning m ikke hndteres, medmindre brugeren er korrekt beskyttet. VIKTIGT: Anv nd skyddskl der vid hantering av lsningsbehllarna. ΠΡΟΣΟΧΗ: Χρησιμοποιείτε το Δοχείο Ρυθμιστικού διαλύματος μόνο αφού λάβετε τις κατάλληλες προφυλάξεις. UPOZORNĚNÍ: Nemanipulujte s nádobou obsahující roztok, pokud není řádně zabezpečena. Consult instructions for use. / Gebrauchsanweisung beachten. / Consulter les instructions d’utilisation. / Consulte las instrucciones de uso. / Consultare le istruzioni per l’uso. / Consultar as instru es de utiliza o. / Se brugsanvisningen. / L s tillhrande dokumentation. / Συμβουλευτείτε τις οδηγίες χρήσης. / Viz návod k použití.

PN 9230334F

Solution Container Label, Rear Panel

CELL-DYN® 3700 System Operator’s Manual

9140320E — September 2004

xi

ABBOTT LABORATORIES Abbott Park, IL 60064 USA

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

PN 9230963 9230751A PN

Small CE Mark Label, Rear of Data Station

CAUTION - CLASS 2 LASER LIGHT WHEN OPEN AND INTERLOCK IS DEFEATED DO NOT STARE INTO THE BEAM PN 9230323

Class 2 Laser Label, Sample Loader Cover

ABBOTT DIAGNOSTICS DIVISION Abbott Laboratories Abbott Park IL, 60064 USA

MADE IN U.S.A.

PN 9230010 REV K

Serial Number Label, Rear of Data Station

xii

CELL-DYN® 3700 System Operator’s Manual

9140320E — September 2004

Conventions Used in This Manual The following conventions are used in this manual: Information

Presentation

Examples

ALL CAPS, BOLDFACE

NOTE:

MONOSPACE FONT, BOLDFACE

Ready

<Sans Serif Font, Angle Brackets>

<Date/Time>

Menu names

SANS SERIF FONT, ALL CAPS,

SET UP

Soft key names

[SANS SERIF FONT, ALL CAPS, BRACKETS]

[SET UP]

Bold: Bold & Italics

Chapter: Title, Subsection: Heading

Note, Caution, Warning Bulletin message, status, or other screen display Data entry field

References to other text

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

SUBMENU KEYS

TOGGLE KEYS TOGGLE KEYS

CELL-DYN® 3700 System Operator’s Manual

9140320E — September 2004

xiii

Flowchart Conventions Menus are shown as square-cornered rectangles in the flowcharts, and soft keys are shown as round-cornered rectangles: MAIN MENU Ready

SET UP

RUN

DATA LOG

RETIC DATA LOG

QUALITY CONTROL

The Page Down key is depicted as follows: Page Down

When procedures are depicted in flowcharts, shaded boxes and bold lines indicate which soft keys to press: MAIN MENU Ready

xiv

SET UP

RUN

DATA LOG

RETIC DATA LOG

PATIENT LIMITS

REAGENT LOG

QC SET UP MENU

OPERATION SET UP

TURN ON VET PKG

TURN ON RETIC PKG

QUALITY CONTROL

BAR CODE SET UP

CELL-DYN® 3700 System Operator’s Manual

9140320E — September 2004

Safety The CELL-DYN 3700 System has been designed to minimize hazards to the operator. Operation, maintenance, and servicing of hematology systems may expose individuals to potential safety and health hazards. All work must be performed in accordance with procedures described in the CELL-DYN Operator’s Manual or as directed by an Abbott Representative. For detailed Safety information refer to Chapter 8: Hazards. Warnings are inserted in this manual to alert personnel to potential hazards. The standard warning conventions including signal words (e.g., Caution) and symbols are described in Chapter 8: Hazards.

CELL-DYN® 3700 System Operator’s Manual

9140320E — September 2004

xv

Revision Status Document Control Number(s)

Revision Date

Original Issue (9140320A)

12/98

Not Applicable

Not Applicable

9140320B

3/99

Chapter 10 Chapter 14

10-75, 10-76, 14-1, 14-2, 14-25,14-26, 14-29, 14-30, 14-39, 14-40, 14-43, 14-44, 14-59, 14-60, 14-61, 14-62, 14-67, 14-68, 14-71, 14-72, 14-75, 14-76, 14-77, 14-78, 14-85, 14-86, Revision Status viii.

9140320C

11/00

All

All

9140320D

6/03

Master Table of Contents

All

Foreword

All

1: System Description

1-6 through 1-9; 1-11; 1-17 through 1-24; 1-27

2: Installation

2-1; 2-3 through 2-5; 2-14

3: Principles of Operation

3-36

4: System Specifications

4-5 through 4-7; 4-11; 4-23

5: Operating Instructions

5-7; 5-9 and 5-10; 5-12; 5-50; 5-67; 5-88 through 5-91; 5-93 through 5-95; 5-98 through 5-102; 5-119; 5-121; 5-143

6: Calibration

6-3; 6-26; 6-40

7: Quality Control

7-17; 7-25

8: Hazards

All

9: Maintenance

9-3 and 9-4; 9-23 and 9-24; 9-27 through 9-54

10: Troubleshooting

10-32; 10-35 and 10-36; 10-58; 10-60; 10-68; 10-85

12: Sample Loader

12-6 and 12-7; 12-11

13: Veterinary Package

13-44 and 13-45; 13-47; 13-52

14: Reticulocyte

14-1; 14-3; 14-69; 14-71 through 14-75, 14-77 and 14-78; 14-81

Appendix A

All

Appendix B

New

Index

New

xvi

Section(s) Revised

Pages Revised and Added

CELL-DYN® 3700 System Operator’s Manual

9140320E — September 2004

Document Control Number(s)

Revision Date

9140320E

CELL-DYN® 3700 System Operator’s Manual

9140320E — September 2004

9/2004

Section(s) Revised

Pages Revised and Added

Master Table of Contents

All

Foreword

All

1: System Description

1-1; 1-6; 1-9; 1-24 through 1-27

2: Installation

2-1; 2-3; 2-5; 2-9; 2-12 and 2-13; 2-15

3: Principles of Operation

3-36 through 3-49; 3-55 and 3-56

4: System Specifications

4-6; 4-11; 4-17; 4-19

5: Operating Instructions

5-17 through 5-19; 5-50; 5-87 through 5-89; 5 103; 5-110; 5-123

6: Calibration

6-1; 6-3; 6-30; 6-35; 6-38; 6-53; 6-57; 6-64; 6-68 and 6-69; 6-79; 6-82 and 6-83; 6-89 and 6-90; 6-92 through 6-96

7: Quality Control

7-15 through 7-19; 7-23; 7-26

9: Maintenance

9-2 and 9-3; 9-19 and 9-20; 9-23; 9-26 and 9-27; 9-29 and 9-30; 9-32 through 9-34; 9-36 and 9-37; 9-40; 9-43; 9-45 and 9-46; 9-48; 9-52; 9-54

10: Troubleshooting

10-23; 10-25; 10-28; 10-32; 10-34 through 10-37; 10-42; 10-57 and 10-58; 10-60 through 10-65; 10-76; 10-78 through 10-87

11: Printers

11-4; 11-6; 11-13

12: Sample Loader

12-1 and 12-3

13: Veterinary Package

13-8

14: Reticulocyte

14-14; 14-32 through 14-34; 14-69; 14-71; 14-82

Appendix A

7 and 8

Appendix B

1 and 2; 4

Appendix C

New

xvii

Document Control Number(s) 9140320F

xviii

Revision Date 4/2007

Section(s) Revised

Pages Revised and Added

Master Table of Contents

All

List of Figures

All

List of Tables

All

Foreword

i through iv; vi and vii, x, xviii through xx

1: System Description

1-5; 1-19 through 1-21; 1-23 through 1-32

2: Installation

2-7 through 2-20

3: Principles of Operation

3-1 through 3-20; 3-36; 3-39; 3-43 through 3-64

4: System Specifications

4-15; 4-17; 4-20; 4-23; 4-25

5: Operating Instructions

5-88; 5-90 through 5-91; 5-143

6: Calibration

6-5 and 6-6; 6-29; 6-35; 6-99

7: Quality Control

7-9; 7-16 through 7-17

9: Maintenance

9-54

10: Troubleshooting

10-61

11: Printers

All

13: Veterinary Package

13-8

14: Reticulocyte

14-7 and 14-8; 14-68; 14-69; 14-71; 14-77 and 14-78; 14-83

Bibliography

All

Appendix B

B-4

Index

All

CELL-DYN® 3700 System Operator’s Manual

9140320F — April 2007

Revision Log Instructions: Use this log to provide a permanent record to verify that revised chapter(s) and/or page(s) have been added to this manual. 1. Record the document control number of the revised section in the first column. You will find the number in the footer. Make an entry for each chapter you receive and place in the manual. 2. Record the revision date, also found in the footer, in the second column. 3. Record the current CELL-DYN 3700 System software version in the third column. 4. Write your initials or signature in the fourth column to verify that you have placed the revised page(s) in the manual. 5. Record the date that you added the revised section to the manual in the fifth column.

Document Control Number

Revision Date

CELL-DYN® 3700 System Operator’s Manual

9140320F — April 2007

Software Version

Revision Incorporated by

Date Incorporated

xix

NOTES

xx

CELL-DYN® 3700 System Operator’s Manual

9140320F — April 2007

Chapter 1

System Description

System Description

Overview The CELL-DYN 3700 System is a multi-parameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The instrument has two versions: the CELL-DYN 3700SL System with an automated Sample Loader and the CELL-DYN 3700CS System with a manual Closed Sampler.

Insert Color Photo

Figure 1.1:

CELL-DYN 3700SL System

The CELL-DYN 3700SL System is equipped with an automated Sample Loader module. The Sample Loader provides continuous closed sampling for up to 100 tubes at a time. (See the preceding figure.) The CELL-DYN 3700CS System is equipped with a built-in manual Closed Sample Aspiration Module referred to as the Closed Sampler. The Closed Sampler aspirates blood from a closed collection tube that has been inserted in the Closed Sampler Module.

CELL-DYN® 3700 System Operator’s Manual

9140320E — September 2004

1-1

System Description Chapter 1

Overview

NOTES

1-2

CELL-DYN® 3700 System Operator’s Manual

9140320C — November 2000

Chapter 1

System Description

Intended Use The CELL-DYN® 3700 System generates the following hematologic measurements on EDTA-anticoagulated whole blood: WBC — White Blood Cell or Leukocyte count NEU — Neutrophil absolute count

%N — Neutrophil percent

LYM — Lymphocyte absolute count

%L — Lymphocyte percent

MONO — Monocyte absolute count

%M — Monocyte percent

EOS — Eosinophil absolute count

%E — Eosinophil percent

BASO — Basophil absolute count

%B — Basophil percent

RBC — Red Blood Cell or Erythrocyte count HGB — Hemoglobin concentration HCT — Hematocrit MCV — Mean Corpuscular Volume MCH — Mean Corpuscular Hemoglobin MCHC — Mean Corpuscular Hemoglobin Concentration RDW — Red Cell Distribution Width PLT — Platelet or Thrombocyte count MPV — Mean Platelet Volume PDW*— Platelet Distribution Width PCT* — Plateletcrit RETIC % — Reticulocyte Percent RETIC ABS — Reticulocyte Absolute IRF — Immature Reticulocyte Fraction * Clinical significance has not been established for these parameters. Therefore they are not reportable in the U.S. They are provided for laboratory use only.

CELL-DYN® 3700 System Operator’s Manual

9140320C — November 2000

1-3

System Description Chapter 1

Intended Use

NOTES

1-4

CELL-DYN® 3700 System Operator’s Manual

9140320C — November 2000

System Description Chapter 1

System Components

System Components The two main modules of the CELL-DYN 3700 System are depicted in the following two figures. (The Sample Loader Module included with the CELL-DYN 3700SL System is illustrated and described in Chapter 2: Installation and Chapter 12: Sample Loader.)

Data Station

Figure 1.2:

Analyzer

CELL-DYN 3700 System

Analyzer: The Analyzer contains the hardware to aspirate, dilute, and analyze each whole blood specimen. Data Station: The Data Station contains a Flat Panel Display Monitor, a Keyboard, and a CPU (Central Processing Unit).

CELL-DYN® 3700 System Operator’s Manual

9140320F — April 2007

1-5

System Description Chapter 1

System Components

Analyzer Overview The Analyzer is the central unit of the CELL-DYN 3700 System. It aspirates and dilutes whole blood specimens, transports and analyzes the prepared dilutions, and rinses fluidic components in preparation for the next specimen. Except for those components directly related to the Closed Sample Processing Method (automated or manual), the CELL-DYN 3700CS System and CELL-DYN 3700SL System are identical. In the description of components on the following pages, those components applicable to only one of the systems will be identified as such. A complete description of the automated Sample Loader can be found in Chapter 12: Sample Loader.

Front Panel The components visible on the front of the Analyzer are depicted in the following figure. The functional description of each component follows. Right Front Cover

Left Front Cover

Viewing Window

Status Indicator Panel

Open Sample Aspiration Probe

Tube Retainer Closed Sample Aspiration Module Figure 1.3:

1-6

Touch Plate

CELL-DYN 3700CS System Analyzer Front View

CELL-DYN® 3700 System Operator’s Manual

9140320E — September 2004

System Description Chapter 1

System Components

Left Front Cover The removable Left Front Cover protects the Left Flow Panel. To remove the cover, lift up on the cover to free it from the mounting brackets. A grounding wire provides electrical continuity for shielding purposes. Disconnect the grounding wire. Access to the Left Flow Panel is necessary to view the action of the Flow Panel components and to perform certain maintenance procedures.

Right Front Cover The removable Right Front Cover protects the Right Flow Panel. It contains a window that allows the operator to view the Shear Valve. The cover is removed by lifting it up, disconnecting the ground wires, and lifting away from the mounting brackets. Access to the Right Flow Panel is necessary to view the operation of the components and to perform certain maintenance procedures.

Status Indicator Panel Three status indicator messages (illuminated by green, yellow, and red LEDs) indicate the status of the Analyzer. The status messages are: •

Ready (green light) — The Analyzer is ready to process a specimen.

•

Busy (yellow light) — The Analyzer is busy with a normal operational sequence.

•

Fault (red light)

— The Analyzer is unable to process specimens due to an existing fault condition.

Open Sample Aspiration Probe The Open Sample Aspiration Probe aspirates whole blood from an opened collection tube. The Wash Block moves down to the end of the probe and remains there whenever the Closed Mode is selected.

Touch Plate The Touch Plate is located directly behind the Open Sample Aspiration Probe. Pressing the Touch Plate starts the selected run cycle for both the Open Mode and Closed Mode on the CELL-DYN 3700CS System. If the Closed Sampler Mode is selected on the CS instrument, the cycle will begin only if a tube has been properly inserted in the holder. On the CELL-DYN 3700SL System, the Touch Plate is used for Open Mode only. CELL-DYN® 3700 System Operator’s Manual

9140320D — June 2003

1-7

System Description Chapter 1

System Components

Closed Sample Aspiration Module (CELL-DYN 3700CS System Only) The Closed Sample Aspiration Module aspirates whole blood from a closed collection tube. It is activated when the Closed Sampler Mode is selected. The module contains the following components: •

A Holder holds the closed collection tube.

•

A Tube Retainer correctly positions the tube in the holder.

•

Two Quick Adjust Levers located on either side of the Tube Retainer are used to raise or lower the Tube Retainer in order to securely hold the collection tube in the proper position.

•

An Interlock Switch located in the Tube Retainer prevents activation of the Closed Sampler until a collection tube is inserted properly.

•

A Needle pierces the collection tube stopper, vents vacuum or pressure from inside the tube, aspirates the whole blood, and is retracted and rinsed at the end of each Closed Sampler cycle.

Automated Sample Loader Module (CELL-DYN 3700SL System Only) See Chapter 12: Sample Loader for information about the Sample Loader Module.

Flow Panel The major components of the Flow Panel are depicted in the following figure. The functional description of each component follows.

1-8

CELL-DYN® 3700 System Operator’s Manual

9140320D — June 2003

Figure 1.4:

CELL-DYN® 3700 System Operator’s Manual

9140320E — September 2004

RBC/PLT Diluent Overpressure Sensor

Vacuum Accumulator Drain Line RBC/PLT Metering Assembly

Grounding Wire Clip

Waste Chamber 2

Shear Valve Assembly

Mounting Bracket

Sample Aspiration Peristaltic Pump

WOC Sheath Syringe (contains Sheath Reagent)

Touch Plate

Open Sample Aspiration Probe

Wash Block

Normally Closed Valves

Optical Bench Assembly

Grounding Wire Clip

RBC/PLT Diluent Syringe (contains Diluent)

Mounting Bracket

HGB/WIC Diluent Syringe (contains Diluent)

HGB/WIC Lyse Syringe (contains HGB/WIC Lyse)

A.C.C. Interlock Switch

WOC Metering Syringe (contains Sheath Reagent)

WOC Flow Cell Cover

WOC Mixing Chamber

Chapter 1

Waste Chamber 1

von Behrens RBC/PLT Transducer Assembly

Mounting Bracket

WIC Metering Assembly

HGB Flow Cell

WOC Transfer Peristaltic Pump

von Behrens WIC Transducer Assembly

Aerosol Filter

Overflow Chamber

Mounting Bracket

System Description System Components

.

Analyzer Flow Panel Components

1-9

System Description Chapter 1

System Components

Sample Aspiration Peristaltic Pump The Sample Aspiration Peristaltic Pump is composed of a rotor and pump tube holder. It aspirates whole blood from either an open or closed collection tube into the Shear Valve. The pump action is controlled by the Touch Plate and an optical detector.

Shear Valve Assembly The three-piece ceramic Shear Valve isolates a precise volume of whole blood by means of a shearing action as the front and rear sections rotate. The aspirated blood is isolated in three separate segments — one for the WOC dilution, one for the WIC/HGB dilution, and one for the RBC/PLT dilution.

Wash Block The Wash Block rinses the outside of the Open Sample Aspiration Probe with Diluent. It air dries the probe and routes the external and internal rinses to a waste chamber.

Syringe Assembly The Syringe Assembly contains a set of five syringes: two WIC/HGB Syringes operated by the same stepper motor and three others (RBC Diluent, WOC Sheath, and WOC Metering Syringes), each operated by a separate stepper motor. •

RBC/PLT Diluent Syringe — delivers a specific volume of Diluent to transport the blood from the Shear Valve to the Mixing Chamber in the von Behrens RBC/PLT Transducer.

•

WIC/HGB Diluent Syringe — delivers a specific volume of Diluent to transport the blood from the Shear Valve to the WIC/HGB Mixing Chamber in the von Behrens WIC Transducer.

•

WIC/HGB Lyse Syringe — dispenses a specific volume of WIC/HGB Lyse into the WIC/HGB Mixing Chamber at the same time as the diluted sample is dispensed into the chamber.

•

WOC Sheath Syringe — delivers a specific volume of Sheath Reagent to transport the blood from the Shear Valve to the WOC Mixing Chamber.

•

WOC Metering Syringe — injects a specific volume of the WOC dilution into the WOC Flow Cell.

Waste Chambers Two Waste Chambers collect the waste liquid from the Analyzer Flow Panel.

1-10

CELL-DYN® 3700 System Operator’s Manual

9140320C — November 2000

System Description Chapter 1

System Components

ACC Interlock Switch An Aperture Cleaning Circuit (ACC) Interlock Switch inhibits the operation of the Aperture Cleaning Circuit when the front covers are removed.

RBC/PLT Metering Assembly The RBC/PLT Metering Assembly contains a precision-bore glass tube with a set of optical detectors, one upper and one lower, mounted on it. It meters a fixed volume of the RBC/PLT dilution to ensure that an accurate volume is counted during the RBC/PLT measurement.

von Behrens RBC/PLT Transducer Assembly The von Behrens RBC/PLT Transducer Assembly contains the fluidics and hardware required for accurate measurement of the diluted red blood cells and platelets. The primary components of this assembly are: •

von Behrens RBC/PLT Transducer - The Transducer contains two chambers. The Mixing Chamber on the left is for mixing the RBC/PLT dilution. The Counting Chamber on the right contains the von Behrens Plate used to prevent cells that have traversed the aperture from recirculating into the sensing zone.

•

Electrodes - There are two non-corrosive, electrically conductive plates, one positively charged and one negatively charged. One electrode is located in each Transducer Chamber. The electrodes conduct a constant current flow through the aperture during the RBC/PLT measurement.

•

RBC/PLT Aperture Plate -This plate is inserted into a slot between the two Transducer Chambers. A jewel containing the aperture is pressure-embedded into the plate.

WIC (WBC Impedance Count) Metering Assembly The WIC Metering Assembly contains a precision-bore glass tube with a set of optical detectors, one upper and one lower, mounted on it. It meters a fixed volume of the HGB/WIC dilution to ensure that an accurate volume is counted during the WIC measurement.

CELL-DYN® 3700 System Operator’s Manual

9140320D — June 2003

1-11

System Description Chapter 1

System Components

HGB Flow Cell Assembly The HGB Flow Cell Assembly contains the following components: •

A fully enclosed (light-tight), flow-through glass Cuvette

•

An LED light source

•

A Bandwidth Filter used to obtain the ICSH recommended wavelength of 540 nm

•

A Photodetector for measuring the light transmitted

WOC (WBC Optical Count) Transfer Peristaltic Pump The WOC Transfer Peristaltic Pump is composed of a rotor and a pump tube holder. It transports the WOC dilution to the WOC Flow Cell.

von Behrens WIC Transducer Assembly The von Behrens WIC Transducer Assembly contains the fluidics and hardware required for accurate measurement of the diluted white blood cells. The primary components of this assembly are: •

von Behrens WIC Transducer — The Transducer contains two chambers. The Mixing Chamber on the left is for mixing the WIC/HGB dilution. The Counting Chamber on the right contains the von Behrens Plate used to prevent cells that have traversed the aperture from recirculating into the sensing zone.

•

Electrodes — There are two non-corrosive, electrically conductive plates, one positively charged and one negatively charged. One electrode is located in each transducer chamber. The electrodes conduct a constant current flow through the aperture during the WIC measurement.

•

WIC Aperture Plate — This plate is inserted into a slot between the two Transducer Chambers. A jewel containing the aperture is pressure-embedded into the plate.

Aerosol Filter The Aerosol Filter is used to filter aerosols out of the air that leaves the instrument.

Overflow Chamber The Overflow Chamber collects excess fluid from the Mixing Chambers.

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CELL-DYN® 3700 System Operator’s Manual

9140320C — November 2000