CELL-DYN 3700 Operator’s Manual April 2007

Master Table of Contents

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

CELL-DYN® 3700 Operator’s Manual

9140320F - April 2007

Master Table of Contents

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

CELL-DYN® 3700 Operator’s Manual

9140320F - April 2007

Master Table of Contents - 3

Master Table of Contents

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

Master Table of Contents - 4

CELL-DYN® 3700 Operator’s Manual

9140320F - April 2007

Master Table of Contents

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

CELL-DYN® 3700 Operator’s Manual

9140320F - April 2007

Master Table of Contents - 5

Master Table of Contents

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

Master Table of Contents - 6

CELL-DYN® 3700 Operator’s Manual

9140320F - April 2007

Master Table of Contents

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

CELL-DYN® 3700 Operator’s Manual

9140320F - April 2007

Master Table of Contents - 7

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

Master Table of Contents - 8

CELL-DYN® 3700 Operator’s Manual

9140320F - April 2007

Master Table of Contents

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

CELL-DYN® 3700 Operator’s Manual

9140320F - April 2007

Master Table of Contents - 9

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

Master Table of Contents - 10

CELL-DYN® 3700 Operator’s Manual

9140320F - April 2007

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... 3-11 Figure 3.2: WOC Flow Cell... 3-14 Figure 3.3: WBC Light Scatter... 3-15 Figure 3.4: Optical Bench Assembly... 3-17 Figure 3.5: Mononuclear-Polymorphonuclear Scatter... 3-20 Figure 3.6: Neutrophil-Eosinophil Scatter... 3-21 Figure 3.7: Mononuclear Scatter... 3-22 Figure 3.8: WBC Histograms... 3-24 Figure 3.9: WBC Data and Scatterplots... 3-25 Figure 3.10: Volumetric Metering... 3-28 Figure 3.11: RBC Data and Histogram... 3-30 Figure 3.12: PLT Data and Histogram... 3-33 Figure 3.13: Flagging Diagnostics Screen... 3-41 Figure 3.14: Scatterplot with Increased Stroma in the N1 Region... 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

CELL-DYN® 3700 Operator’s Manual

9140320F - April 2007

Master Table of Contents-11

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

Master Table of Contents-12

CELL-DYN® 3700 Operator’s Manual

9140320F - April 2007

List of Figures

Figure 5.46: Data Log Screen Showing Accept Into X-B Key 5-128 Figure 5.47: Customize Display for Data Log Screen... 5-129 Figure 5.48: Customize Display Showing Standard Groups . 5-130 Figure 5.49: Customize Printout for Data Log Screen... 5-132 Figure 5.50: Print Data Log Screen... 5-134 Figure 5.51: Customize Display for Data Log Screen Showing Standard Groups... 5-135 Figure 5.52: Customize Printout for Data Log Screen Showing Customized Print Group... 5-138 Figure 5.53: Display Specimen Screen... 5-140 Figure 5.54: Edit Specimen Screen... 5-142 Figure 6.1: Calibration Screen Displaying Open Mode Calibration Factors... 6-14 Figure 6.2: Calibration Menu Screen Displaying Closed Mode Calibration Factors... 6-15 Figure 6.3: Enter Calibration Factor Screen... 6-16 Figure 6.4: Calibration Log Screen... 6-18 Figure 6.5: Auto-Calibration Screen for CELL-DYN 3700CS System... 6-19 Figure 6.6: Whole Blood Auto-Cal Screen... 6-20 Figure 6.7: Whole Blood Auto-Cal Screen... 6-22 Figure 6.8: Whole Blood Auto-Cal Results Screen... 6-23 Figure 6.9: Whole Blood Auto-Cal Results Screen with Results... 6-24 Figure 6.10: Calibrator Auto-Cal Screen... 6-25 Figure 6.11: Latex Auto-Cal Screen... 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

CELL-DYN® 3700 Operator’s Manual

9140320F - April 2007

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

CELL-DYN® 3700 Operator’s Manual

9140320F - April 2007

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... 14-10 Figure 14.2: Operation Set Up Menu Screen with Reticulocyte Package Enabled... 14-12 Figure 14.3: Reticulocyte Main Menu Screen... 14-14 Figure 14.4: Reticulocyte Set Up Screen... 14-16 Figure 14.5: Reticulocyte Patient Limits Screen... 14-18 Figure 14.6: Reticulocyte QC Set Up Screen... 14-19 Figure 14.7: Retic QC Range Entry Screen... 14-21 Figure 14.8: Retic QC Means/Limits Screen... 14-22 Figure 14.9: Retic Set Up QC Screen... 14-25

CELL-DYN® 3700 Operator’s Manual

9140320F - April 2007

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

CELL-DYN® 3700 Operator’s Manual

9140320F - April 2007

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... 6-41 Table 6.2: Calibration Criteria... 6-51 Table 6.3: Calibration Criteria... 6-63 Table 6.4: Mode to Mode Calibration Criteria... 6-78 Table 6.5: Mode to Mode Calibration Criteria... 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... 13-5 Table 13.2: Accuracy... 13-6 Table 13.3: Linearity... 13-7 Table 13.4: Carryover... 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

9140320F - April 2007

Master Table of Contents-17

List of Tables

NOTES

Master Table of Contents-18

CELL-DYN® 3700 Operator’s Manual

9140320F - April 2007

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.

CELL-DYN® 3700 System Operator’s Manual

9140320F - April 2007

i

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.

ii

CELL-DYN® 3700 System Operator’s Manual

9140320F - April 2007