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Abbott CELL-DYN 3200, System Operator'S Manual

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Abbott CELL-DYN 3200 System Operator'S Manual Download Page 41

CELL-DYN

®

3200 System Operator’s Manual

List of Figures-1

9140181H—October 2001

List of Figures

List of Figures

Use or Function

Figure 1.1

CELL-DYN 3200SL. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  1-1

Figure 1.2

CELL-DYN 3200CS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  1-2

Figure 1.3

CELL-DYN 3200 System Components . . . . . . . . . . . . . . . . . . . . . .  1-5

Figure 1.4

CELL-DYN 3200SL Analyzer Front Panel . . . . . . . . . . . . . . . . . . .  1-8

Figure 1.5

Flow Panel Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  1-10

Figure 1.6

Left Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  1-14

Figure 1.7

Right Side Panel Components  . . . . . . . . . . . . . . . . . . . . . . . . . . . .  1-15

Figure 1.8

Rear Panel Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  1-16

Figure 1.9

Power Supply Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  1-18

Figure 1.10

Optical Bench . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  1-19

Figure 1.11

Data Module Components - Rear Panel . . . . . . . . . . . . . . . . . . . . .  1-20

Figure 1.12

Display Station Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  1-22

Figure 1.13

Sample Loader Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  1-23

Installation Procedures and Special Requirements

Figure 2.1

Reagent Inlet Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  2-6

Figure 2.2

Analyzer Front Covers — SL Model . . . . . . . . . . . . . . . . . . . . . . . .  2-7

Figure 2.3

Sample Loader Tower. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  2-8

Figure 2.4

Sample Loader Mounting Screws. . . . . . . . . . . . . . . . . . . . . . . . . . .  2-8

Figure 2.5

Normally Closed Valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  2-9

Figure 2.6

Tubing in a Normally Closed Valve . . . . . . . . . . . . . . . . . . . . . . . .  2-10

Figure 2.7

CELL-DYN 3200 Printer Ports  . . . . . . . . . . . . . . . . . . . . . . . . . . .  2-12

Figure 2.8

Analyzer With Sample Loader . . . . . . . . . . . . . . . . . . . . . . . . . . . .  2-15

Figure 2.9

Tube Rack Showing Label Placement Locations . . . . . . . . . . . . . .  2-16

Principles of Operation

Figure 3.1

Optical Bench . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  3-7

Figure 3.2

Optical Flow Cell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  3-9

Figure 3.3

WBC Light Scatter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  3-10

Figure 3.4

Mononuclear-Polymorphonuclear Scatter  . . . . . . . . . . . . . . . . . . .  3-12

Figure 3.5

Neutrophil-Eosinophil Scatter  . . . . . . . . . . . . . . . . . . . . . . . . . . . .  3-13

Figure 3.6

Mononuclear Scatter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  3-14

Figure 3.7

WBC Histograms  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  3-17

Figure 3.8

WBC Data and Scatterplots  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  3-18

Figure 3.9

RBC Data and Histogram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  3-20

Figure 3.10

PLT Data and Histogram  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  3-22

Figure 3.11

Laboratory Worksheet Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . .  3-24

Summary of Contents for CELL-DYN 3200

Page 1: ...n diagnosing isolating and correcting problems Abbott Laboratories is dedicated to manufacturing the highest quality most reliable instrumentation available We look forward to serving your needs in any way possible Customer Support United States 1 800 CELL DYN or 1 800 235 5396 Abbott Diagnostics Customer Support Center 200 Abbott Park Road Abbott Park Il 60064 Canada 1 800 387 8378 For customers ...

Page 2: ...o the original purchaser or until title is transferred from the original purchaser whichever occurs first the Warranty Period If any defects occur during the Warranty Period contact your Abbott Hematology Customer Support Center immediately and be prepared to furnish pertinent details concerning the defect the Instrument model number and the serial number Abbott s Warranty coverage limits are as f...

Page 3: ...MENT AND ABBOTT SPECIFICALLY DISCLAIMS ALL OTHER WARRANTIES EXPRESSED OR IMPLIED INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY AND OF FITNESS FOR A PARTICULAR PURPOSE The CELL DYN 3200 Series Hematology Systems are manufactured by Abbott Diagnostics Abbott Laboratories at 5440 Patrick Henry Drive Santa Clara CA 95054 U S A Please direct all inquiries concerning information in this manual to ...

Page 4: ...istered trademark of Oki America Inc Millipore is a registered trademark of Millipore Corporation OKIDATA is a registered trademark of Oki America Inc Retic RITE is a registered trademark of Abbott Laboratories Sarstedt is a registered trademark of Walter Sarstedt Gerate a German Company Technicon H 3 is a registered trademark of Miles Inc TEFLON is a registered trademark of E I DuPont de Nemours ...

Page 5: ...mmunications Port 2 Pressure 3 Fault Ready Frequency Revision Fuse Serial number Fuses Service disk High Speed Serial Link Set Up disk Installation Disk Shear Valve Keyboard Touch Line frequency select Trap Line Voltage Vacuum 1 Line Voltage Select Video Graphics Adapter First Parallel Printer Port Vent Second Parallel Printer Port Waste Maximum power Waste sensor Model number Y Valve Peristaltic ...

Page 6: ...n Hemoglobin Lyse Lot Number Red Blood Cell Sheath Storage temperature Example shows Store at 2º 8ºC White Blood Cell White Blood Cell Lyse Calibrator Control related Control Assay Whole Blood Calibrator Whole Blood Control Whole Blood Control High Whole Blood Control Low Whole Blood Control Normal 1 5 12 6 8 17 8 17 6 7 1 0 7 1 5 21 175 7 02 2 1 6 27 5 6 7 8oC 2oC 6 21752 66 2 22 5 725 2 22 21752...

Page 7: ... 3200 System Operator s Manual vii 9140181K July 2002 Miscellaneous Authorized Representative Consult instructions for use Date of Manufacture For In Vitro Diagnostic Use Legal Manufacturer List Number 5 3 9 5 ...

Page 8: ...CKEN EVITER TOUTE EXPOSITION DIRECTE AU FAISCEAU LASER NO SE EXPONGA DIRECTAMENTE AL RAYO LASER EVITARE OGNI ESPOSIZIONE DIRETTAAL RAGGIO LASER LIGHT WHEN OPEN BEI OFFENER ABDECKUNG TRITT LASERSTRAHL AUS RAYON LASER SI OUVERT RADIACION LASER SI SE ABRE LUCE LASER SE APERTO DANGER GEFAHR DANGER PELIGRO PERICOLO PN 9230701D Class l Laser Product per lEC 825 1 1993 PN 9230702A ABBOTT DIAGNOSTICS A wh...

Page 9: ...ngen der Bedienungsanleitung 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 CONFIGURADO PARA 120 VOLTIOS Si se necesita otra tensión diferente a la indicada consulte el Manual de Operaciones para instrucciones más detalladas CONFIGURATO PER 120 VOLT Se la tensione è di vol...

Page 10: ...e the following labels Laser Label Front Panel Laser Label Rear Panel Serial Number Label Rear Panel CAUTION CLASS 3B LASER LIGHT WHEN OPEN AVOID EXPOSURE TO BEAM PN 9230701 CLASS 1 LASER PRODUCT PN 9230702 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 MANUFACTU...

Page 11: ...graphics contained in this manual ABBOTT Max Planck Ring 2 65205 Wiesbaden Germany 49 6122 580 ABBOTT LABORATORIES Abbott Park IL 60064 USA PN 9230751A WARNING SET FOR 120 VOLTS When operation at other line voltage is required refer to Operator s Manual for detailed instructions PN 9230003E CAUTION DO NOT HANDLE SOLUTION CONTAINER UNLESSPROPERLY PROTECTED REFER TO OPERATOR S MANUAL FOR INSTALLATIO...

Page 12: ...xii CELL DYN 3200 System Operator s Manual 9140181K July 2002 NOTES ...

Page 13: ...purposes and explain various icons that identify specialized types of information in the text Please take the time to read and understand this brief preparatory section Manual Organization Front Matter The pages in front of the Master Table of Contents contain two main sections A Foreword that includes customer support and intended use information and How to Use This Manual that includes a descrip...

Page 14: ...rom the operation of the instrument as well as decontamination and waste handling procedures Section 9 Service and Maintenance This section discusses routine maintenance and cleaning on a daily weekly monthly and as needed basis Also included are detailed instructions for removing cleaning and replacing various components to ensure proper system performance Section 10 Troubleshooting and Diagnosti...

Page 15: ...dix B lists the part numbers of components accessories controls reagents and consumables associated with the CELL DYN 3200 System for user convenience when placing orders Index This section contains an alphabetical listing of subject matter to help users quickly locate specific information about the system Manual Construction The physical construction of the manual supports its sectional organizat...

Page 16: ... pressure sensitive keypad on the front of the instrument Such keys include the Enter key the ESC key the pound key and other special function keys Special function keys such as the arrow keys are in regular type The arrow symbol may be substituted for the word For example the text will read Press the arrow keys or Press the key or Press the arrow key The Print Screen key on the keyboard can be us...

Page 17: ...ance and servicing of hematology systems may expose individuals to potential safety and health hazards All work must be performed as described in the CELL DYN Operator s manual or as directed by an Abbott Representative For detailed safety information refer to Section 8 Hazards Warnings are inserted throughout this manual to alert personnel to potential hazards The standard warning conventions inc...

Page 18: ...through 14 19 List of Figures p 3 1 Use or Function pp 1 1 and 1 2 1 8 1 18 and 1 19 2 Installation Procedures and Special Requirements pp 2 3 2 7 2 15 3 Principles of Operation p 3 7 4 Performance Characteristics and Specifications pp 4 4 and 4 5 5 Operating Instructions pp 5 8 5 10 5 99 6 Calibration pp 6 21 6 26 6 30 through 6 32 6 57 7 Operational Precautions and Limitations pp 7 1 and 7 2 8 H...

Page 19: ... 3 16 3 28 3 31 through 3 36 4 Performance Characteristics and Specifications pp 4 4 and 4 5 5 Operating Instructions pp 5 8 5 10 5 42 through 5 44 5 86 and 5 87 5 99 5 128 6 Calibration pp 6 21 6 26 6 30 through 6 32 6 57 7 Operational Precautions and Limitations pp 7 1 and 7 2 8 Hazards All 9 Service and Maintenance pp 9 12 9 21 9 25 9 46 9 55 and 9 56 9 59 9 61 10 Troubleshooting and Diagnostic...

Page 20: ... footer in the second column 3 Record the current CELL DYN 3200 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 Conclusion We hope you have found this preview of the manual useful The information i...

Page 21: ...ments iv Symbols v Instrument Labeling viii How to Use This Manual xiii Overview xiii Manual Organization xiii Manual Construction xv Text Conventions Used in This Manual xvi Soft Keys Screen Label Keys xvi Keyboard Keypad Keys xvi Safety xvii Revision Status xviii Revision Log xx Conclusion xx Use or Function 1 1 Overview 1 1 Intended Use 1 2 System Components 1 5 Analyzer Components 1 6 Front Pa...

Page 22: ...sed Valves 1 12 Diluent Reservoir 1 12 Sheath Reservoir 1 12 Waste Chambers 1 12 Bubble Traps 1 12 Aerosol Filter 1 12 Pinch Valves 1 12 Closed Mode Aspiration Tower 1 12 Left Side Panel 1 14 Fan 1 14 Right Side Panel 1 15 Floppy Disk Drive Slot 1 15 Rear Panel 1 16 Main Power Switch 1 16 Analyzer Serial Number Label 1 16 Data Module 1 16 Disk Storage Container 1 16 Fan 1 16 Waste Sensor Connector...

Page 23: ... 1 22 Soft Keys 1 22 Video Cable 1 23 Power Cord 1 23 Sample Loader Components 1 23 Racks 1 23 Tower Cover 1 24 Bar Code Reader 1 24 Tube Sensor Assembly 1 24 Tube Mixer Assembly 1 24 Closed Sample Aspiration Tower Module 1 24 Printer 1 25 Reagent System 1 25 Introduction 1 25 CELL DYN Reagents 1 26 CELL DYN 3200 Diluent Sheath 1 26 CELL DYN 3200 CN Free HGB NOC Lyse 1 26 CELL DYN 3200 WBC Lyse 1 ...

Page 24: ...cket Printer 2 14 Self Test Printouts 2 14 Sample Loader Inspection SL Model 2 15 Power On 2 17 Principles of Operation 3 1 Overview 3 1 Sample Aspiration 3 1 Sample Analysis Cycle Overview 3 3 Sample Aspiration 3 3 Sample Segments 3 3 RBC PLT Analysis 3 3 Hemoglobin Analysis 3 4 WBC Analysis 3 4 Results Displayed 3 6 Instrument Flushed 3 6 Instrument Rinsed 3 6 Flow Cytometry 3 7 Introduction to ...

Page 25: ...1 RDW 3 21 RBC Flagging 3 21 Platelet Parameters 3 21 PLT Count 3 22 MPV 3 22 PCT 3 22 PDW 3 22 Platelet Flagging 3 22 Hemoglobin Measurement 3 23 Overview 3 23 HGB Parameters 3 23 HGB Flagging 3 23 Laboratory Worksheet Screen 3 24 Operational Messages and Data Flagging 3 27 Introduction 3 27 Instrument Fault and Status Conditions 3 27 Cell Populations and Flagging 3 28 Fragile WBCs 3 28 Lyse Resi...

Page 26: ... 6 Bar Code Label Specifications 4 6 Measurement Specifications CELL DYN 3200SL and CS 4 7 Measurement Channels 4 7 WBC WOC 4 7 WBC NOC 4 7 RBCs and PLTs 4 7 HGB 4 7 Retic 4 8 Performance Specifications 4 9 Background Counts 4 9 Carryover 4 9 Precision 4 10 Hemogram Parameters 4 11 WBC Differential Parameters 4 11 Linearity 4 12 Correlation 4 13 Hemogram Parameters 4 13 WBC Differential Parameters...

Page 27: ...ostics Menu Flowchart continued 5 11 Special Protocols Flowchart 5 12 Set Up Instructions 5 13 Set Up Menu 5 13 Date Time 5 14 Patient Limits 5 16 Reagent Log 5 18 QC Set Up Menu 5 21 Operation Set Up Menu 5 37 Units Selection Menu 5 45 Customize Report 5 47 Routine Operation 5 59 General Information 5 59 Power ON Procedure 5 59 Initializing the System 5 60 Operating the Instrument 5 61 Power OFF ...

Page 28: ...ample Mixing 5 86 Sample Analysis on the CELL DYN 3200SL 5 87 Introduction 5 87 Instrument Preparation 5 87 Sample Loader Operating Tips 5 88 Daily Quality Control Checks 5 88 Open Mode QC Procedure 5 88 Closed Mode QC Procedure 5 89 Running Samples 5 89 Open Mode Analysis 5 90 Open Mode Procedure 5 90 Closed Mode Analysis 5 91 Closed Mode Procedure 5 91 Sample Analysis on the CELL DYN 3200CS 5 93...

Page 29: ... Work List Menu 5 107 Work List 5 107 Work List Screen 5 109 Work List Soft Keys 5 110 Work List Set Up Procedure 5 111 Sample Analysis SL Model 5 115 Closed Mode 5 115 Open Mode 5 118 Sample Analysis CS Model 5 120 Closed Mode 5 120 Open Mode 5 123 Using The Data Log 5 125 Introduction 5 125 Scrolling Through the Data Log 5 125 DATA LOG Menu 5 125 Edit ID 5 127 Display Specimen 5 127 Find Specime...

Page 30: ...d 6 12 Calibration Menu 6 13 Overview 6 13 Calibration Menu Soft Keys 6 15 Enter Factor 6 15 Calibration Log 6 16 Auto Calibrate 6 17 Auto Cal Method 6 19 Overview 6 19 Methodology 6 19 Auto Cal Menu 6 21 Start Auto Cal 6 21 Delete a Run 6 24 Quit 6 24 Accept 6 24 Auto Cal Procedure Open Mode 6 26 Displaying the Auto Cal Screen 6 26 Entering Reference Values 6 26 Processing Samples 6 26 Calibratio...

Page 31: ...rameters Need Calibration 6 39 Entering New Calibration Factors Open Mode 6 41 Confirming Open Mode Calibration 6 42 Calibration Procedure Mode to Mode 6 43 Determining the Closed Mode Mean 6 43 Determining Which Parameters Need Calibration 6 45 Calculating New Closed Mode Calibration Factors 6 46 Entering New Calibration Factors Closed Mode 6 47 Confirming Closed Mode Calibration 6 48 Post Calibr...

Page 32: ... Service and Maintenance 9 1 Overview 9 1 Special Protocols 9 3 Special Protocols Menu 9 3 Reagent Reservoir 9 4 Empty Fill Flow Cell 9 5 Clean Restore Shear Valve 9 5 Disable Enable Analyzer 9 5 More 9 6 Auto Clean 9 6 Daily Shutdown 9 7 Prepare Shipping 9 7 Clean Needle 9 7 Extended Auto Clean 9 7 More 9 7 Preventive Maintenance Schedule 9 9 Overview 9 9 Preventive Maintenance Schedule 9 10 Dail...

Page 33: ...enance Procedures 9 21 Fan Filter Cleaning 9 21 Materials Required 9 22 Filter Cleaning Procedure 9 22 Extended Auto Clean 9 23 Materials Required 9 24 Procedure 9 24 Diluent Sheath Filter Replacement Procedure 9 25 Materials Required 9 25 Procedure 9 25 Semiannual Maintenance Procedures 9 27 Printer Cleaning 9 27 Nonscheduled Maintenance Frequency 9 29 Nonscheduled Maintenance Procedures 9 31 She...

Page 34: ... Cleaning 9 48 Open Sample Probe Replacement 9 48 Materials Required 9 48 Procedure 9 48 Closed Sample Needle Replacement 9 50 Materials Required 9 50 Procedure 9 50 Sample Transfer Pump Tubing Replacement 9 52 Materials Required 9 52 Procedure 9 52 Normally Closed Valve Tubing Replacement 9 53 Materials Required 9 53 Procedure 9 53 Syringe Replacement 9 55 Materials Required 9 55 Procedure 9 55 F...

Page 35: ... 19 Serial Test 10 20 Fifth Diagnostics Menu Screen SL Model 10 22 Troubleshooting Guide 10 23 Introduction to Troubleshooting 10 23 Obtaining Technical Assistance 10 24 Customer Support 10 24 Troubleshooting Procedures 10 25 Troubleshooting Tips and Techniques 10 25 Introduction 10 25 Troubleshooting Background Count 10 25 Troubleshooting Reagent Problems 10 26 Troubleshooting the Sampling error ...

Page 36: ...1 15 Mixing and Handling 11 15 Assay Verification 11 16 Running Controls 11 17 CELL DYN 3200 Westgard Rules 11 18 Overview 11 18 Westgard Rules 11 18 Rule Violations 11 19 X B Analysis 11 20 Introduction 11 20 X B Program Operation 11 21 X B Analysis for RBC 11 23 X B Analysis for WBC 11 25 References 11 27 Printers 12 1 Overview 12 1 Maintenance and Troubleshooting 12 3 Cleaning 12 3 Troubleshoot...

Page 37: ...ple Loader Components 13 5 Bar Code Label Placement 13 6 RUN Screens 13 9 Soft Keys 13 10 Overview 13 10 Start Loader 13 11 Stop Loader 13 11 Restarting the Loader 13 11 Fault Conditions 13 12 Processing Stations 13 13 Rack Movement 13 14 Load Side 13 14 Mixing and Aspiration Stations 13 15 Unload Side 13 16 Sample Identification 13 17 Stopping the Sample Loader 13 18 Sample Loader Operation 13 19...

Page 38: ...es Setup 14 20 Operation Set Up Soft Key 14 22 Units Selection 14 23 Retic Run Menu 14 24 Retic Data Log Menu 14 24 Edit ID 14 27 Display Specimen 14 28 Find Specimen 14 30 Transmit Data 14 30 Print Data Log 14 31 Data Review from the Retic Data Log 14 32 Retic QC Menu 14 33 View QC Log 14 35 Retic Diagnostics Menu 14 39 Fault Report 14 41 Retic Count Rate 14 41 Clear Faults 14 42 Retic Raw Data 1...

Page 39: ...ontrol Specimens 14 66 Troubleshooting 14 67 Overview 14 67 General Guidelines for Reticulocyte Troubleshooting 14 67 Operational Messages and Data Flagging 14 68 Dispersional Data Alerts 14 68 Instrument Alert Messages 14 68 High Background Counts 14 69 References 14 70 Appendix A Bar Codes A 1 Overview A 1 Bar Code Function A 1 Understanding the Label s Code A 2 Bar Code Types and Characteristic...

Page 40: ...stem Operator s Manual 9140181K July 2002 Master Table of Contents I2of5 A 11 Codabar A 12 Code 128 A 13 Acknowledgment A 14 Appendix B Parts List B 1 Overview B 1 CELL DYN 3200 Accessories B 1 CELL DYN 3200 Optional Accessories B 2 Index Index 1 ...

Page 41: ...d Special Requirements Figure 2 1 Reagent Inlet Panel 2 6 Figure 2 2 Analyzer Front Covers SL Model 2 7 Figure 2 3 Sample Loader Tower 2 8 Figure 2 4 Sample Loader Mounting Screws 2 8 Figure 2 5 Normally Closed Valves 2 9 Figure 2 6 Tubing in a Normally Closed Valve 2 10 Figure 2 7 CELL DYN 3200 Printer Ports 2 12 Figure 2 8 Analyzer With Sample Loader 2 15 Figure 2 9 Tube Rack Showing Label Place...

Page 42: ... Set Up Screen 5 42 Figure 5 21 Units Selection Screen 5 45 Figure 5 22 Customize Printed Report Screen for the Graphics Printer 5 48 Figure 5 23 Customize Printout Header Screen for the Graphics Report 5 50 Figure 5 24 Customize Printed Report Screen for Blank Tickets 5 52 Figure 5 25 Customize Printed Report Screen for Pre Printed Tickets 5 54 Figure 5 26 Customize Displayed Report Screen 5 56 F...

Page 43: ...139 Figure 5 55 Customize Printout for Data Log Screen Showing Customized Print Group 5 141 Figure 5 56 Display Specimen Screen 5 143 Figure 5 57 Find Specimen Screen 5 144 Figure 5 58 Edit Specimen Screen 5 145 Calibration Procedures Figure 6 1 Calibration Menu Screen Displaying Open Sampler Calibration Factors 6 13 Figure 6 2 Calibration Menu Screen Displaying Closed Sampler Calibration Factors ...

Page 44: ...uent Sheath Syringe Replacement 9 44 Figure 9 18 HGB Flow Cell Access Tubing 9 46 Figure 9 19 Open Sample Probe Replacement 9 49 Figure 9 20 Closed Sample Needle 9 51 Figure 9 21 Tubing in Normally Closed Valve 9 54 Figure 9 22 Fuse Replacement 9 56 Figure 9 23 Y Valve Cleaning 9 60 Troubleshooting and Diagnostics Figure 10 1 First Diagnostics Menu Screen 10 3 Figure 10 2 Operator Correctable Faul...

Page 45: ...d Rule Violations 11 19 Sample Loader Figure 13 1 Analyzer With Sample Loader 13 1 Figure 13 2 CELL DYN 3200 Sample Loader 13 5 Figure 13 3 Tube Labeling Requirements 13 7 Figure 13 4 Rack with Bar Code Labels 13 8 Figure 13 5 CELL DYN 3200SL RUN Screen 13 9 Figure 13 6 Sample Loader Restart Screen 13 10 Figure 13 7 Sample Loader Stations 13 14 Figure 13 8 Rack Movement 13 15 Figure 13 9 Unload Si...

Page 46: ... Screen 14 40 Figure 14 23 Reticulocyte Count Rate Screen Tabular Format 14 41 Figure 14 24 Reticulocyte Count Rate Screen Graphic Format 14 42 Figure 14 25 Reticulocyte Raw Data Screen 14 43 Figure 14 26 Reticulocyte Special Protocols Screen 14 44 Figure 14 27 Reticulocyte Specimen Type Screen 14 49 Figure 14 28 The First Reticulocyte Patient Specimen Screen 14 50 Figure 14 29 The Second Reticulo...

Page 47: ...iculocyte 4 10 Table 4 8 Precision of the Hemogram Parameters N 20 4 11 Table 4 9 Precision of the WBC Differential Parameters N 20 4 12 Table 4 10 Linearity Specifications 4 12 Table 4 11 Accuracy of Hemogram Parameters 4 13 Table 4 12 Accuracy of WBC Differential Parameters 4 14 Table 4 13 Flagging Analysis Using both the Distributional and Morphological Flags 4 14 Table 4 14 Typical Precision o...

Page 48: ...Control Table 11 1 Troubleshooting X B RBC 11 25 Reticulocyte Package Table 14 1 Known or Potential Interferents 14 60 Table 14 2 Instrument Alert Messages 14 68 Table 14 3 Data Invalidating Alerts 14 69 Parts List Table B 1 CELL DYN 3200 Accessories Kit B 1 Table B 2 CELL DYN 3200 Sample Loader Accessories Kit B 2 Table B 3 CELL DYN 3200 Optional Accessories B 2 Table B 4 CELL DYN 3200 Controls C...

Page 49: ...ersions unless either the Closed Sampler CS or Sample Loader SL model is specifically stated The terms open sample and closed sample are used interchangeably with open sampler and closed sampler Generally when referring to the mode of operation the terms Open Sampler and Closed Sampler are used and when referring to components of the instrument Open Sample and Closed Sample are used e g Open Sampl...

Page 50: ... DYN 3200 is a multiparameter automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories The CELL DYN 3200 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 Mon...

Page 51: ...oncentration 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 Count Clinical significance has not been established for these parameters Therefore they are not reportable ...

Page 52: ...1 4 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Use or Function Overview Section 1 NOTES ...

Page 53: ...olor monitor and pressure sensitive keypad for selecting the displayed commands that operate the system The Sample Loader attaches to the front of the CELL DYN 3200SL Analyzer and is an integral part of the SL model The Sample Loader is discussed throughout this manual where appropriate It is also discussed in detail in Section 13 Sample Loader Figure 1 3 CELL DYN 3200 System Components CELL DYN 3...

Page 54: ... Plate Flow Panel Closed Sample Aspiration Tower Module Shear Valve Assembly Syringes 4 Sample Transfer Peristaltic Pump Optical Flow Cell Assembly Laser Optics Bench Assembly behind Flow Panel HGB Flow Cell Mixing Assembly WBC Mixing Chamber RBC PLT Mixing Chamber Open Sample Aspiration Probe and Wash Block Normally Closed Valves 6 Diluent Reservoirs 2 Open Closed Mode Switching Assembly Y Valve ...

Page 55: ...tor Line Frequency and Line Voltage Select Switches Fuse Fan with Air Intake Filter Serial and Parallel Interface Ports Data Module Keyboard Connector Port Touch Pad Connector Port Waste Sensor Connector Waste Outlet Tube Connector Diluent Sheath Inlet Tube Connector WBC Lyse Inlet Tube Connector HGB Lyse Inlet Tube Connector Analyzer Serial Number Label Disk Storage Container ...

Page 56: ... to perform certain maintenance procedures The cover is held in place by hinges and magnetic fasteners located on the top inside edge of the cover Right Front Cover The Right Front Cover protects the right portion of the flow panel and supports the Touch Plate and Status Indicator Panel The cover is hinged on the right opening from the center to expose the right half of the flow panel Access to th...

Page 57: ...to aspirate whole blood from an opened collection tube The wash block moves down to the end of the probe and returns to a position that is covered by the Right Front Cover When Closed Sampler mode is selected the Wash Block moves down to the end of the probe and remains down until the Open Sampler mode is again selected Touch Plate The Touch Plate is used to start the run cycle for 1 both the Open...

Page 58: ... located before and after the shear valve ensure the integrity of the aspirated specimen In both Open and Closed modes an ultrasonic sensor checks the segment as it is aspirated Additionally in the Closed mode an optical sensor checks the segment as it exits the shear valve 1 Vent Filter 2 Vent 3 Sample Transfer Peristaltic Pump 4 Waste Chambers 5 WBC Mixing Chamber 6 RBC Mixing Chamber 7 HGB Flow...

Page 59: ...ion Syringe injects a specific volume of the diluted sample into the Optical Flow Cell for RBC PLT WBC WOC and WBC NOC measurements Sample Transfer Peristaltic Pump The Sample Transfer Peristaltic Pump is composed of a rotor and a pump tube holder It is used to transfer the WBC dilution RBC PLT dilution and HGB NOC dilution to the Optical Flow Cell from their respective mixing chambers HGB Flow Ce...

Page 60: ...ng into the atmosphere Pinch Valves The Pinch Valves not shown are used to control air and liquid throughout the Analyzer Closed Mode Aspiration Tower The Aspiration Tower contains the Aspiration Vent Needle Needle Wash Block Sample Tube Spinner Assembly and tubing to aspirate blood samples from closed sample tubes Vent Aspiration Needle The Vent Aspiration Needle combines both venting and aspirat...

Page 61: ...SL model the Bar Code Reader is located to the left of the Mixing Assembly on the Sample Loader Door Assembly CS Model The Door Assembly consists of a tube holder door Bar Code Reader Interlock Switch and electrical latch to open the door after aspiration has occurred The Interlock Switch will cause the instrument to halt if the door is opened between the time the Touch Plate is pressed and the sy...

Page 62: ...0181H October 2001 Use or Function System Components Section 1 Left Side Panel The only major component on the Left Side Panel is the Fan shown in Figure 1 6 Fan A Fan cools the internal components of the Analyzer Figure 1 6 Left Side Panel 1 Fan 1 ...

Page 63: ...Right Side Panel The only major component on the Right Side Panel is the Floppy Disk Drive shown in Figure 1 7 Figure 1 7 Right Side Panel Components Floppy Disk Drive Slot The Floppy Disk Drive allows information to be downloaded or uploaded using a 3 5 floppy disk 1 Floppy Disk Drive Slot 1 ...

Page 64: ...al Number Label Although not an instrument component the Analyzer Serial Number may be required when consulting with the Abbott Hematology Customer Support Center Data Module See Subsection Data Module Components later in this section Disk Storage Container This container is used to store the Installation and Set Up disks Fan A Fan cools the internal components of the Analyzer 1 Main Power Switch ...

Page 65: ...te is routed to a drain the dummy plug supplied in the accessory kit must be inserted in the connector Waste Outlet Tube Connector This port is used to connect the waste outlet tube Reagent Inlet Panel Diluent Sheath Inlet Tube Connector This color coded red port is used to connect the diluent inlet tube with its associated cap sinker and label WBC Lyse Inlet Tube Connector This color coded purple...

Page 66: ...n at other line voltage is required refer to Figure 1 9 Figure 1 9 Power Supply Module Main Power Connector This receptacle is used to connect the main power cord to the instrument Fuse An 8 amp 110 120 V T Slo Blo or 4 amp 220 240 V T Slo Blo Fuse protects the Analyzer from electrical spikes WARNING SET FOR 120 VOLTS When operation at other line voltage is required refer to Operator s Manual for ...

Page 67: ...lly clear quartz chamber with a central square opening of a specific size which flares out into a cone at the bottom of the flow cell Laser Optics Bench Assembly The Laser Optics Bench Assembly located behind the Flow Panel contains the Helium Neon laser the flow cell and the optics and detectors required for enumeration and differentiation of white blood cells red blood cells and platelets refer ...

Page 68: ...RAM expandable to 16 megabytes VGA graphics with 1 megabyte cache 2 enhanced parallel ports and 2 serial ports 2 FIFO UART Com1 and Com2 ports 3 PCI slots Data Storage Data storage consists of a 3 5 inch 1 4 megabyte Floppy Disk Drive and a one gigabyte EIDE enhanced IDE Hard Disk Drive 1 PC Keyboard Connector 2 COM1 LIS Connector 3 COM2 Unused 4 Analyzer BDM Diagnostics Unused 5 HSSL Connector 6 ...

Page 69: ...Information System to the Data Module COM2 is unused Analyzer BDM Diagnostics Unused HSSL High Speed Serial Link Connectors The High Speed Serial Link transfers data between the Analyzer and the Data Module The HSSL Connector on the Data Module connects to the HSSL Connector on the back panel of the Analyzer Membrane Keypad Interface Connector The Membrane Keypad Interface Connector allows data to...

Page 70: ... allows commands to be transferred from the Display Monitor to the Data Module Screen Controls The Controls available on the Display Monitor are shown in Figure 1 12 The Brightness and Contrast controls are located under the control panel shown in the figure Soft Keys A row of eight unlabeled pressure sensitive Soft Keys membrane keypad is located directly below the screen Each key initiates a fun...

Page 71: ...ly and provides power to the monitor and keypad Sample Loader Components The major components of the Sample Loader are depicted in Figure 1 13 A description of each component s function follows Figure 1 13 Sample Loader Components Racks Each Sample Loader Rack is able to accommodate up to 10 tubes Racks are labeled with rack number and tube position and with a 2 digit Bar Code 39 format 1 Aspirati...

Page 72: ...rack advances the tube holder descends and grabs the tube The tube holder rotates 15 times in an outward motion of approximately 135 degrees The double tube configuration of the tube holder allows each tube to be held and mixed twice in succession before it passes to the mixing station An air cylinder governs the rotation movement of the tube holder Closed Sample Aspiration Tower Module The Closed...

Page 73: ...DYN 3200 Series instrument flow systems in order to provide optimal system performance Use of reagents other than those specified in this manual is not recommended as instrument performance can be affected Each CELL DYN 3200 system is checked at the factory using the specified reagents and all performance claims are generated using these reagents The reagents used with the CELL DYN 3200 are RBC PL...

Page 74: ...0 x K µL CELL DYN 3200 CN Free HGB NOC Lyse List Number 03H80 02 CELL DYN CN Free HGB NOC Lyse is formulated to meet the following requirements Rapidly lyse the red blood cells and minimize the resultant stroma Strip the white cell cytoplasm leaving the nuclear membrane intact so the white cell nuclei can be enumerated Convert hemoglobin to a stable chromagen complex that is measurable at 555 nm C...

Page 75: ... were generated using these reagents Reagent must be stored in the dark at room temperature All reagents should be protected from direct sunlight extreme heat and freezing during storage CAUTION If any reagent has been frozen it must not be used Reagent tubes have been capped to minimize evaporation However reagent quality may deteriorate with time Therefore use all reagents within the dating peri...

Page 76: ...1 28 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Use or Function System Components Section 1 NOTES ...

Page 77: ... The remainder of this chapter gives general requirements for a successful installation Procedures are also included for installing the Printer and Sample Loader Initial Preparation Package Inspection and Inventory The instrument is shipped from the factory as follows CELL DYN 3200SL 1 crate containing the instrument including Sample Loader 1 box containing the CELL DYN Accessory kit and Sample Lo...

Page 78: ...he system is delivered If desired the trucking company will transport the instrument to the laboratory and place it in the designated space Inspect the remaining boxes for damage If there is any damage or if any crates or boxes are missing contact the Abbott Hematology Customer Support Center for assistance The reagents needed for installation are shipped when the instrument is shipped This shipme...

Page 79: ...procedures Away from direct sunlight Away from the path of a cooled or heated air outlet Away from any other instruments that may interfere with it such as a centrifuge any x ray equipment MRI equipment a CRT a video terminal a computer or a copier Place the reagents below the instrument Waste Disposal Requirements Observe the following requirements for waste routing and disposal Allow room for a ...

Page 80: ...cated at the desired site before attempting any connections A minimum of three power outlets are required for either model one outlet for the Analyzer one for the Printer and one for the Display Station If a Ticket Printer will also be installed a fourth power outlet will be needed Grounded power outlets and a voltage regulator for the Analyzer are required for optimum performance ...

Page 81: ...r rinsing the flow system Wipe the outside of the tubing with a damp lint free pad such as DYN A WIPE and place the weighted end into the container of CELL DYN Diluent Sheath Secure the cap Place the container on the same level as or lower than the unit 5 Attach the non weighted end of the tubing with the Blue HGB Lyse label to the Blue Connector This reagent is for the HGB dilution Wipe the outsi...

Page 82: ...ug refer to Appendix B Parts and Accessories Normally Closed Valves To gain access to all six Normally Closed Valves on the Flow Panel open both the Left and Right Front Covers and remove the Tower Cover Remove the Front Skirt CS model or move the Sample Loader SL model away from the instrument Refer to instructions later in this section for opening and removing these components Before shipment th...

Page 83: ... expose the right side of the Flow Panel Because of the attached Touch Plate and Status Panel this cover should not be removed from the instrument Remove Tower Cover To remove the Tower Cover on both the SL and CS tower door on the CS model must be open models rotate tower away from front panel using hand hold Lift bottom of cover off skirt locating pins and gently pull the top of the cover away f...

Page 84: ...ows Gently pull on cover using hand hold and swing door open about 30 45 degrees Lift door fully upward from bottom area closest to door hinge bracket then rotate door fully open so that the lift and hold feature on upper door hinge mechanism is engaged 3 Remove the screw that holds the Sample Loader Tower in place on the Front Panel Refer to the following figure Figure 2 3 Sample Loader Tower 4 L...

Page 85: ...uent tubing 1 Locate the six normally closed valves on the flow panel Refer to Figure 2 5 for the location of these valves 2 The procedure described below applies to all the Normally Closed Valves on the Flow Panel Refer to Figure 2 6 3 Select any of the Normally Closed Valves Carefully insert the diluent tubing into the slot at the top of the valve Work the tubing firmly back and forth with a flo...

Page 86: ...urn the Main Power Switch to ON 4 Before putting the front covers and skirt back on the instrument run several background counts by pressing the Touch Plate to observe proper functioning of the instrument Check for leaks crimps in the tubing and the opening of the Solenoid pinch valves Observe the operation of the syringes The syringes should move freely up and down with no evidence of air bubbles...

Page 87: ...white graphic reports and the Ticket Printer prints tickets or black and white graphic reports Depending on the output desired one or both printers may be connected to the instrument Follow installation instructions carefully to be sure that the printer s is connected to the correct port See Figure 2 7 For convenience general instructions are provided for loading individual pre printed tickets in ...

Page 88: ...one end into the parallel port on the rear of the printer There is a metal plate covering the printer s serial port to avoid confusion Fasten the wire clips to the connector for a secure connection 4 Plug the other end of the printer cable into the Graphics Printer port on the back of the Data Module See Figure 2 7 Tighten the screws on the connector for a secure connection NOTE This port is confi...

Page 89: ...actor feed sheets Pre printed tickets must be loaded individually 1 Assemble the printer as directed in the printer manual 2 Make sure that the printer power switch is OFF Plug the power cord into the back of the printer and plug the other end into a grounded outlet 3 Make sure that the power to the instrument is turned OFF Remove the printer cable which looks like a power cord with two connectors...

Page 90: ...n 5 Raise the separator to its upright position 6 Place a ticket on the paper separator and adjust the guides so that they barely touch the edges of the ticket 7 Pull the bail lever forward The ticket will automatically feed into place Release the bail lever 8 Be sure the printer is deselected Sel indicator is not illuminated Set the Top of Form by pressing and holding the TOF Quiet key and pressi...

Page 91: ...mmunication between the Analyzer and loader The Analyzer and Sample Loader are also connected by two quick disconnect tube lines one for pressure and one for vacuum The tube spinning and sample aspiration mechanism on the Tower Module is identical on both the SL and CS models The Tower Cover on the SL model differs from its counterpart on the CS model in two ways 1 It is larger in order to extend ...

Page 92: ... for signs of damage 6 Verify that each rack has a bar code label in position 1 and that the label is on the same side as the open slots Refer to Figure 2 9 for proper label placement and alignment NOTE For the Sample Loader to operate properly the racks must be placed to the right of the tower the load area with the labels and slots facing the operator not the Analyzer so that the Bar Code Reader...

Page 93: ...priming process is complete the READY light on the Analyzer s indicator panel is lit and the message READY is displayed in the Status Box on the monitor 2 Prime the Sample Loader by running several blood samples in the Closed Mode If necessary refer to the directions given in Section 5 Operating Instructions Subsection Sample Analysis on the CELL DYN 3200SL Running Samples Closed Mode Procedure 3 ...

Page 94: ...2 18 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Installation Procedures and Special Requirements Printer Installation Section 2 NOTES ...

Page 95: ...g each instrument cycle the sample is aspirated diluted and mixed before each parameter is measured NOTE An increase in flags will occur in RRBC and FWBC modes Sample Aspiration There are two modes of whole blood sample aspiration on the CELL DYN 3200 The operator selects the mode of aspiration from the RUN screen The Open Sampler Mode is used to aspirate the sample from a collection tube that has...

Page 96: ...3 2 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Principles of Operation Overview Section 3 NOTES ...

Page 97: ...L of diluent through the Shear Valve where the 1 67 µL RBC PLT volume is transferred to the RBC Mixing Chamber 2 The segment and diluent are then routed to the RBC PLT Mixing Chamber where the dilution is swirl mixed The final dilution is 1 1675 3 The Sample Transfer Pump transfers the RBC PLT dilution from the RBC PLT Mixing Chamber to the Optical Flow Cell Sample Feed Nozzle 4 Diluent Sheath rea...

Page 98: ...ear valve where the 20 µL WBC volume is transferred to the WBC Mixing Chamber 2 The segment and reagent are then routed to the WBC Mixing Chamber where the dilution is swirl mixed The final dilution is 1 50 The diluted sample remains in the mixing chamber for 14 seconds for the lysing of the red blood cells 3 The Sample Transfer Pump transfers the WBC dilution from the WBC Mixing Chamber to the Op...

Page 99: ...eported as WBC based on algorithmic decision making on the RUN screen and Laboratory Worksheet NOTE When QC specimen type is selected both NOC and WOC are reported in the Data Log Either NOC or WOC is reported as WBC based on algorithmic decision making on the RUN screen The analysis for Fragile WBC and Resistant RBC is performed as follows 1 After the HGB sample is measured refer to Hemoglobin An...

Page 100: ...piration process is flushed to Waste Chamber 2 2 The remaining segments in the WBC and RBC Mixing Chambers are flushed to Waste Chamber 3 3 The segments sent to the Optical Flow Cell are flushed to Waste Chamber 1 Instrument Rinsed 1 The Open Sample Aspiration Probe is rinsed internally and externally with diluent sheath 2 In Closed Mode the needle is rinsed internally and externally with diluent ...

Page 101: ...attering of light the physical or chemical characteristics of the cells or particles 3 Flow cytometry enables the rapid screening of large numbers of cells and provides quantitative cell analysis at the single cell level The basic components of a flow cytometer include A sample collector and transporter A flow system to focus the sample flow stream A light source and focusing optics Light collecto...

Page 102: ... light were allowed to reach the 0 and 10 forward detectors it would saturate the electronics Therefore an obscuration bar blocks 0 1 of the forward unscattered light beam The forward angles of scatter are directed to a perforated mirror The 0 1 3 light scatter passes through the mirror to the 0 silicon photodiode detector The 10 7 10 or narrow angle light scatter is deflected off the mirror to th...

Page 103: ...area they intersect with the laser beam The different types of cells scatter the laser light at different angles yielding information about cell size internal structure granularity and surface morphology The optical signals the cells generate are detected and converted to electrical impulses which are then stored and analyzed by the computer Flow cytometers generally measure two angles of scatter ...

Page 104: ...tical Flow Cell and injected into the cell At the same time the Sample Metering Syringe injects 46 5 µL of the WBC dilution into a sheath stream The sample stream is then hydrodynamically focused to align the cells in single file as they pass through the Optical Flow Cell which is an optically clear quartz chamber A vertically polarized Helium Neon Laser is the light source The instrument measures...

Page 105: ...asophilic granules The RBCs are also altered by the reagent The osmotic pressure of the RBC is higher than that of the reagent Therefore the hemoglobin in the RBC diffuses out of the cell and water from the reagent diffuses into the cell The cell membrane remains intact but the RBC now has the same refractive index as the sheath thereby rendering it invisible to the laser WBC Differential The ligh...

Page 106: ... seen on the display The mononuclear cells fall in the cluster in the lower left corner of the scatterplot and the polymorphonuclear cells fall in the cluster above and to the right of them The instrument uses a dynamic threshold to determine the best separation between the two populations Each cell is then identified as a MONO or a POLY Once each cell is identified it retains this classification ...

Page 107: ...phonuclear cells are clearly seen on the display The neutrophils fall in the lower of the two clusters The eosinophils fall in the upper cluster The instrument uses a dynamic threshold to determine the best separation between the two populations Each cell is then classified as a NEUT or an EOS All cells scatter a certain amount of 90 D light The eosinophils scatter more 90 D light than any of the ...

Page 108: ...ypically basophils are granulated cells and therefore more complex than the mononuclear cells However the basophilic granules are water soluble and dissolve in the WBC Lyse reagent Consequently the degranulated Basophils becomes a less complex cell that falls into the mononuclear cluster The lymphocytes fall in the lowest large cluster The small population of cells below the lymphocytes contains p...

Page 109: ... axis All scatterplots may be displayed and printed at operator request Nuclear Optical Count Samples containing fragile WBCs are difficult to measure accurately because of the rapid breakdown of cells during the measurement process To obtain an accurate WBC count an alternate method using the HGB segment instead of the WBC segment is used to measure samples containing fragile WBCs The HGB sample ...

Page 110: ...ng in a falsely elevated value When this occurs a significant amount of stroma will be present in the N1 region below the WBC dynamic threshold on the 0º 10º scatterplot When these type of specimens are rerun in the Resistant RBC mode the diluted WBC sample is held in the mixing chamber 15 seconds longer than in the routine patient mode This additional lysing time is used to break down lyse the re...

Page 111: ...ted at the operator s request NWBC LYM MONO Histogram The scatter information is plotted in a histogram format with the relative number of cells on the Y axis and the NWBC Lymphocyte and Monocyte size distribution data on the X axis MONO POLY Histogram The scatter information is plotted in a histogram format with the relative number of cells on the Y axis and the mononuclear and polymorphonuclear ...

Page 112: ...r information has been plotted and the cells have been classified into the five subpopulations the algorithms then determine the WBC and the percent of cells in each subpopulation Once the WBC count is determined the absolute number of cells in each subpopulation is calculated by multiplying that WBC count by the percentage The results are expressed as follows WBC x K µL NEU x K µL and LYM x K µL ...

Page 113: ...s used for the determination of RBC and PLT data During sample aspiration 1 67 µL of sample is segmented in the Shear Valve for RBC PLT measurement The Diluent Sheath Syringe dispenses 2 79 mL of diluent to the Shear Valve The sample and diluent are then transferred to the RBC PLT Mixing Chamber where the dilution is swirl mixed resulting in a 1 1 675 dilution ratio The Sample Transfer Pump transf...

Page 114: ...the Y axis The RBC data are shown in Figure 3 9 RBC Count The Red Blood Cell Count is directly measured and is expressed as follows RBC x M µL Counts below 1 0 x M µL are displayed to three decimal places The RBC count is corrected for coincidence and WBC interference MCV The Mean Cell Volume is the average volume of the individual red blood cells The MCV is derived from the RBC size distribution ...

Page 115: ... Events counted in the RBC PLT dilution between floating thresholds are included in the platelet PLT data which is collected using the 0 and 10 sensors The lower threshold floats between 1 and 3 fL and the upper threshold floats between 15 and 35 fL If there is not enough data to determine the PLT count the lower and upper thresholds are set at 2 and 35 fL respectively Once the thresholds have bee...

Page 116: ... femtoliters PCT The Plateletcrit is the product of PLT and MPV and is analogous to the hematocrit It is expressed in percent and is calculated as follows PCT PLT x MPV 10 PDW Platelet Distribution Width is a measure of the heterogeneity of the PLT population It is expressed as the geometric standard deviation NOTE Clinical significance has not been established for PCT and PDW Therefore they are n...

Page 117: ... reagent lyses the red blood cells converting the hemoglobin that is released by a cyanide free chemical process When the lysing action is completed a low energy LED in the HGB Flow Cell attached to the mixing chamber measures the amount of absorbance which is proportional to the HGB concentration A LED with a wavelength of 555 nm is the light source A photodetector measures the light that is tran...

Page 118: ...atory Worksheet Screen To access the LABORATORY WORKSHEET screen press the Page Down key on the keyboard while the RUN menu is displayed or while the DISPLAY SPECIMEN screen in the DATA LOG menu is displayed The format is fixed and cannot be changed The specimen displayed on the screen is identified by the Specimen ID number and Sequence number in the upper left corner of the screen To print the L...

Page 119: ...ferential Parameter Results K µL WBC 11 15 1 NEU 5 91 2 LYM 3 16 3 MONO 2 06 4 EOS 0 02 5 BASO 0 00 Table 3 2 5 Part Differential Plus Additional Parameters Parameter Results K µL WBC 11 15 NEU 5 91 1 SEG 4 80 2 BAND 0 00 3 IG 1 11 LYM 3 16 4 LYMe 2 01 5 VARL 1 15 MONO 2 06 6 BLST 1 69 7 MONe 0 37 8 EOS 0 02 9 BASO 0 00 ...

Page 120: ...3 26 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Principles of Operation Flow Cytometry Section 3 NOTES ...

Page 121: ... divided into the following categories Instrument Messages Fault Conditions Status Conditions Parameter Flagging Messages Dispersional Data Alerts Suspect Parameter Flags Suspect Population Flags Interpretive Messages Detailed descriptions of the messages in each of the categories are given in this section Instrument Fault and Status Conditions The Instrument Fault and Status conditions are discus...

Page 122: ... resistant to the lysing process When running samples in the Patient mode the hypo osmotic lysing ability of the WBC Lyse reagent is usually insufficient to lyse any lyse resistant RBC cells if present in the time allotted for the WBC count Consequently the unlysed RBCs may be erroneously included in the WBC count resulting in a falsely elevated count In normal patient samples lyse resistant RBCs ...

Page 123: ...ics printout when limits exceeded Result underlined on blank ticket when limits exceeded Result marked with asterisk on preprinted ticket when results exceeded WBC NWBC FWBC NRBC RRBC Leukopenia Leukocytosis Differential NEU LYM MONO EOS BASO Same as WBC DFLT NLMEB DFLT NE DFLT LM DFLT B DFLT LB BAND IG BLAST VAR LYM Neutropenia Neutrophilia Lymphopenia Lymphocytosis Monocytosis Eosinophilia Basop...

Page 124: ...TE MCV MCH MCHC and MPV are unaffected by dilution and do not require correction Suspect Parameter Flags These flags are generated after the instrument evaluates the measured data for a particular parameter or group of parameters The result may be suspect due to interfering substances or the inability of the instrument to measure a particular parameter due to a sample abnormality Introduction to W...

Page 125: ...ents and there is no declining WOC kinetic rate Review smear for the presence of NRBCs and follow your laboratory s review criteria NRBC WBC DFLT NLMEB In addition to the criteria above if the number of analyzed events is high or indicates a likely interference in the WBC count then the WBC alert and DFLT NLMEB flags are also given Review smear for the presence of NRBCs and follow your laboratory ...

Page 126: ...mphocytes M Monocytes E Eosinophils B Basophils If the DFLT NLMEB flag is accompanied by the FWBC flag repeat in the FWBC mode If the DFLT NLMEB flag is accompanied by the RRBC flag repeat in the RRBC mode Review scatterplot for clear separation of cell cluster Review a stained smear to verify the differential values DFLT NE or DFLT LM or DFLT B or DFLT LB The letters in parentheses indicate which...

Page 127: ...e following condition is met The instrument detects 1 of the total WBC count as Blast cells Review a stained smear for the presence of blasts and follow your laboratory s review criteria NOTE When blasts are present they are included in the monocyte count VAR LYM When the FWBC flag is triggered the VAR LYM flag is always set In addition the flag is set if any of the following attributes apply 1 Po...

Page 128: ...nt exceeds the specification troubleshoot accordingly URI 1 Interference in the upper threshold region 15 35fL 25 of PLT peak 2 PLT aggregate count PLT clumps 15 of PLT count URI may be cause by Microcytic RBCs Schistocytes Giant Platelets Sickle Cells Platelet Clumps Review MCV platelet histogram and scatterplot If the scatterplot shows overlap in the RBC or platelet populations or a population i...

Page 129: ...C and or unlysed RRBCs Verify the WBC value by an alternate method according to your laboratory s protocol WOC WBC NRBC NOC WOC low stroma interference and L 60 in the Resistant RBC cycle WOC is selected as WBC count Review a stained smear for the presence of NRBCs NOTE If NRBCs are present report WOC for WBC count Confirm WBC by an alternate method NOC WBC FWBC VAR LYM DFLT NLMEB NOC WOC low stro...

Page 130: ...limit for Neutrophil absolute number Lymphopenia result exceeds the lower limit for Lymphocyte absolute number Lymphocytosis result exceeds the upper limit for Lymphocyte absolute number Monocytosis result exceeds the upper limit for Monocyte absolute number Eosinophilia result exceeds the upper limit for Eosinophil absolute number Basophilia result exceeds the upper limit for Basophil absolute nu...

Page 131: ...of Operation References 1 ICSH The Assignment of Values to Fresh Blood Used for Calibrating Automated Cell Counters Clinical and Laboratory Hematology 1988 10 203 212 2 Clinical Applications of Flow Cytometry ASCP National Meeting Spring 1990 3 Shapiro Howard Practical Flow Cytometry 1984 ...

Page 132: ...3 38 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Principles of Operation References Section 3 NOTES ...

Page 133: ...iled information about the CELL DYN 3200 System Included in this section are Physical Specifications Operational Specifications Bar Code Specifications Measurement Specifications Performance Specifications Performance Characteristics Sample Loader Specifications Specifications for the Host Interface List Number 06H71 01 are not included in this section but can be ordered by calling Abbott Customer...

Page 134: ...4 2 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Performance Characteristics and Specifications Overview Section 4 NOTES ...

Page 135: ...2 cm 7 2 18 3 cm Width 32 8 83 3 cm 32 8 83 3 cm 14 35 5 cm 16 5 41 9 cm 16 1 40 9 cm Depth 29 3 74 4 cm 23 3 59 2 cm 16 40 6 cm 14 5 36 8 cm 9 9 25 1 cm Weight 232 lb 105 5 kg 214 lb 97 3 kg 30 lb 13 6kg 16 5 lb 7 5 kg 9 9 lb 4 5 kg Table 4 2 Dimensions After Packaging for Shipment Analyzer SL Analyzer CS Display Monitor Ticket Printer Dot Matrix Graphics Printer Color Bubble Jet Height 38 96 5 c...

Page 136: ...e Specifications There are no specific environmental conditions for transport or storage Table 4 3 Power Specifications Analyzer Input Requirements Module Voltage Frequency Max Current BTU Hr Analyzer 110 VAC 10 120 VAC 10 220 VAC 10 240 VAC 10 50 60 3Hz 50 60 3Hz 50 60 3Hz 50 60 3Hz 6 amps 6 amps 3 amps 3 amps 1945 1945 1945 1945 Analyzer Sample Loader 110 VAC 10 120 VAC 10 220 VAC 10 240 VAC 10 ...

Page 137: ...e warm up time If the power has been OFF longer than 5 minutes wait 10 minutes after the Auto Startup cycle is complete before processing samples Run Cycle Times Table 4 4 shows the average Run cycle times for different specimen types run in the Open and Closed Modes on the CS and SL models Approximate Aspiration Volumes Whole Blood Open mode 150 µL Closed mode 240 µL Batch Size Up to 50 tubes per...

Page 138: ...ls 1 5 mL Minimum sample volume CS Models 1 5 mL Maximum sample volume 3 mL Sample Loader NOTE The sample volume in the tube must be within the specified limits for adequate mixing and sampling Bar Code Specifications CELL DYN 3200SL Bar Code Format The following formats with or without check digits are acceptable Code 39 Code 128 check digit only Interleaved 2 of 5 Codabar Bar Code Label Specific...

Page 139: ...t sheath and HGB Lyse Data Collection Four angles measured 0 10 90 and 90 depolarized Data collected in 256 channels for each angle of light scatter RBCs and PLTs Method Laser light scatter Light source Vertically polarized 5 10 mW helium neon laser Wave length 632 8 nm Dilution 1 1 675 of blood in diluent sheath Data Collection Three angles measured 0 10 and 90 Data collected in 256 channels for ...

Page 140: ...cations Section 4 Retic Method Laser light scatter of cells stained with New Methylene Blue Light source Vertically polarized 5 10 mW helium neon laser Wave length 632 8 nm Dilution 1 50 of stained blood in WBC Lyse Data Collection Three angles measured 0 10 and 90 Data collected in 256 channels for each angle of light scatter ...

Page 141: ...le blood samples that are used to verify carryover specifications should have results that fall within each laboratory s reference interval normal range Each sample is run in triplicate followed by three background cycles The percent carryover for CBC parameters as shown in Table 4 6 is calculated using the following formula Absolute Carryover Background1 Background3 Table 4 6 Carryover for WOC NO...

Page 142: ...for specimens run in both the Open and Closed modes The stated CV in these tables represents the instrument s precision at a 95 confidence level from N 20 replicate runs based on the same sample NOTE 95 confidence limit means that at least 19 of the 20 determinations meet this limit NOTE N 20 is based on one whole blood sample aliquotted into 4 tubes with each tube run 5 times in Closed mode Fresh...

Page 143: ...mean of the 20 determinations runs Specimens selected for the precision study must have means that fall within the specimen range listed in both tables These samples should not display any of the following suspect Parameter Flags WBC or DFLT To determine the 95 confidence limit of a parameter 1 Find the value listed in the Confidence Limit column for that parameter 2 Add that value to the mean to ...

Page 144: ...s This analysis is performed with the line going through the origin 0 0 except for the RETIC parameter Table 4 10 contains the linearity specifications for the hemogram parameters Table 4 9 Precision of the WBC Differential Parameters N 20 Parameter Specimen Range 95 Confidence Limit Neutrophil 46 75 2 2 Lymphocyte 20 45 2 8 Monocyte 3 5 11 5 2 7 Eosinophil 0 5 8 0 1 0 Basophil 0 5 2 0 1 0 Table 4...

Page 145: ...sed CS and SL may be calibrated Thus it is possible to compensate for differences between modes due to differing aspiration pathways or operational sequences When each mode is properly calibrated according to the directions given in this manual bias between the modes is clinically insignificant Accuracy specifications are determined by correlation to reference values obtained from comparison analy...

Page 146: ...eters Comprehensive Flagging Table 4 12 Accuracy of WBC Differential Parameters Parameter Correlation Coefficient Neutrophil and 0 95 Lymphocyte and 0 94 Monocyte and 0 86 Eosinophil and 0 84 Basophil and 0 73 Table 4 13 Flagging Analysis Using both the Distributional and Morphological Flags Agreement True Negative and True Positive 80 False Positives 20 False Negatives 1 ...

Page 147: ...e same sample NOTE N 20 is based on one whole blood sample aliquotted into 4 tubes with each tube run 5 times The data was obtained from several CELL DYN 3200 systems over a period of weeks These precision values represent the typical performance from instruments that are maintained properly are operating in acceptable environmental conditions and are using only recommended reagents and supplies T...

Page 148: ... were evaluated using the general principles for morphological classifications outlined in the NCCLS H20 A Standard Reference Leukocyte Differential Count Proportional and Evaluation of Instrumental Methods as a guideline The statistics were determined by comparing the CELL DYN 3200 System results with results obtained from a reference CELL DYN 3500 System Discrepant results were arbitrated with a...

Page 149: ...cytic PLTs 6 PLT count 150 K mL 24 Uremic 7 PLT count 450 K mL 25 Paraproteinemia 8 MCV 60 fL 26 Patients on immunosuppressant therapy 9 MCV 110 fL 27 Containing cryoglobulins 10 Containing RBCs resistant to lysis 28 Containing micro clots 11 Containing agranular neutrophils 29 Containing cell fragments 12 Containing variant lymphocytes 30 Platelet satellitosis condition 13 Containing lymphoblasts...

Page 150: ... False Positives 3 19 False Negatives 0 53 Specificity 96 81 Sensitivity 99 47 Table 4 18 shows the manual differential and CELL DYN 3200 differential for false negative results Table 4 17 Flagging Analysis Truth Table CELL DYN 3200 Normal CELL DYN 3200 Morphological Positive CELL DYN 3200 Distributional Positive Total Reference Normal 455 TN 15 FP 0 FP 470 ReferenceMorphological Positive 1 FN 167...

Page 151: ...Loader Physical Specifications The Sample Loader attaches to the front of the CELL DYN 3200SL Analyzer and is an integral part of the SL model Table 4 19 contains the physical specifications for the Sample Loader Table 4 19 Sample Loader Physical Specifications Sample Loader with skirt Height 6 15 2 cm Width 32 5 82 5 cm Depth 6 4 16 2 cm Weight 18 lb 8 1 kg ...

Page 152: ... on Sample Loader operation refer to Section 13 Sample Loader Subsection Sample Loader Description Table 4 20 Sample Loader Operational Specifications Feature Specification Rack Capacity 5 racks on the load side 5 racks on the unload side Tube Capacity 50 10 tubes per rack Sample Throughput 1 Patient 2 FWBC RRBC QC 1 58 samples hour 2 34 samples hour Run Cycle Time 1 Patient 2 FWBC RRBC QC 1 62 se...

Page 153: ...ructions Specimen Collection and Handling Routine Operation Sample Analysis Work List Using the Data Log The three major menus in the program that are used for routine operation SET UP RUN and DATA LOG are discussed in this section The remaining parts of the program are discussed in the following sections Calibration Section 6 Calibration Procedures Special Protocols Section 9 Service and Maintena...

Page 154: ...5 2 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Operating Instructions Overview Section 5 NOTES ...

Page 155: ... key labels displayed across the bottom of this screen are used to access all of the sub menus that are available The main menu keys are listed below MAIN MENU keys SET UP RUN DATA LOG RETIC DATA LOG QUALITY CONTROL CALIBRATION DIAGNOSTICS SPECIAL PROTOCOLS NOTE Reticulocyte menu operating instructions are detailed in Section 14 Reticulocyte Package Main Menu Screen The MAIN MENU screen is divided...

Page 156: ...aracters may be entered An operator ID may also be entered from the main CALIBRATION screen This operator ID will be displayed on all screens and printed on all reports The Status Box is displayed in the top center of the screen This box appears on every screen to show the following Menu in use Analyzer status Other applicable information such as file identity Sample ID number and any existing fau...

Page 157: ...essing one of the MAIN MENU soft keys the appropriate submenu is displayed From the submenus more options are available The MAIN MENU options flowchart is shown on this page On the following pages flowcharts show the submenus under each MAIN MENU option Main Menu Flowchart MAIN MENU SET UP DIAG RUN CALIBRA RETIC QUALITY CONTROL TION NOSTICS SPECIAL PROTOCOLS DATA LOG DATA LOG MAIN MENU KEYS SUBMEN...

Page 158: ... COMPUTER LANGUAGE PARAM SET 1 PARAM SET 2 PARAM SET 3 PRINTOUT CUSTOMIZE SET UP SELECT GRAPH SET 4 PARAM HEADER CUSTOMIZE PARAM SET 1 PARAM SET 2 PARAM SET 3 PRINTOUT CUSTOMIZE SET UP PLACE GRAPH SET 4 PARAM GRAPH CANCEL CUSTOMIZE DISPLAYED REPORT TICKET PRINTER STOP PRINTING CUSTOMIZE DISPLAY CANCEL STOP CONFIRM STOP TOGGLE ON OFF SET UP CUSTOMIZE HEADER CUSTOMIZE PRINTED REPORT Ready TURN X B W...

Page 159: ...IZE REPORT on SET UP MENU RETURN INSERT DELETE RETURN TOGGLE ON OFF STOP LOADER RESET RESUME EDIT ID FIND SPECIMEN PREVIOUS SPECIMEN NEXT SPECIMEN EDIT SPECIMEN SPECIMEN TRANSMIT DATA LOG DISPLAY SPECIMEN MAIN TRANSMIT DATA PRINT DATA LOG RETURN PRINT REPORT CUSTOMIZE DATA LOG REPORT CUSTOMIZE TICKET PRINT see CUSTOMIZE REPORT on SET UP MENU SELECT PARAMETER STANDARD GROUPS RETURN CANCEL CONFIRM P...

Page 160: ...GROUP 4 X B CUSTOMIZE PRINTOUT MAIN FILE X B SET UP LOAD MEANS LIMITS FROM DISK GROUP 2 GROUP 1 RETURN PRINT TURN X B WBC ON TURN X B WBC OFF RETURN PRINT X B WBC GRAPHS X B WBC DATA DELETION CANCEL CONFIRM DELETION RETURN STANDARD SELECTION CANCEL SELECTION SELECT PARAMETER RETURN WRITE HIGH WRITE NORMAL WRITE LOW PLACE PARAMETER RETURN STANDARD GROUPS CANCEL SELECTION SELECT PARAMETER PLACE PARA...

Page 161: ...OG PRINT AUTO CALIBRATE CLOSED SAMPLER OPEN SAMPLER RESTORE FACTORS RESET ALL TO 1 000 RETURN RETURN PRINT LOG CLOSED SAMPLER OPEN SAMPLER CALIBRATOR WHOLE BLOOD RETURN QUIT RETURN START AUTO CAL CANCEL QUIT CONFIRM QUIT QUIT DELETE A RUN RETURN PRINT ACCEPT PRINT CANCEL QUIT CONFIRM QUIT NOTE Instrument will reflect last mode of calibration either whole blood or calibrator ...

Page 162: ...NGS MORE VOLTAGE READINGS GAIN ADJUSTMNT MAIN FINISH SELECT SELECT VERIFY GAINS CURRENT SETTINGS AUTO GAIN ADJUSTMNT MORE FPU TEST LOADER TEST TOWER TEST MAIN NOC HISTOGRAM RBC HISTOGRAM PLT HISTOGRAM PRINT WBC 1 DATA EXTENDED WBC COUNT WBC 2 DATA SMOOTHING ON OFF CALC CV SCATTER GRAPHS TUBE SENSOR START RACE ADV WBC 1 HISTOGRAM WBC 2 HISTOGRAM PRINT SHEAR VAL DISPENSE MOTOR PWR CHECKING SHEAR VAL...

Page 163: ...0 HISTOGRAM RBC 10 HISTOGRAM MORE MORE RBC 90 HISTOGRAM SMOOTHING ON OFF PLT 0 DATA PLT 10 DATA PRINT PLT 0 HISTOGRAM PLT 10 HISTOGRAM NOC 00 NOC 10 NOC 0 DATA NOC 10 DATA NOC 90 NOC10 NOC 0 HISTOGRAM NOC 10 HISTOGRAM NOC 90 NOC00 RBC LIN 90 DATA RBC LIN 0 DATA RBC LIN 10 DATA RBC VOLUME DATA RBC LIN 0 HISTOGRAM RBC LIN 10 HISTOGRAM SMOOTHING ON OFF RBC LIN DATA RBC LIN 90 HISTOGRAM PRINT CALC CV ...

Page 164: ...LYZER EMPTY FILL FLOW CELL CLEAR FAULT CLEAN RES SHEAR VALVE REAGENT RESERVOIR MAIN RETURN EMPTY WBC LYSE EMPTY HGB LYSE EMPTY DIL SHEATH MAIN EXTEND AUTOCLEAN MORE AUTO CLEAN CLEAN NEEDLE DAILY SHUTDOWN PREPARE SHIPPING FILL WBC LYSE FILL HGB LYSE FILL DIL SHEATH EMPTY FLOW CELL RETURN FILL FLOW CELL CLEAN SHEAR RETURN VALVE RESTORE SHEAR VALVE DISABLE ANALYZER RETURN ENABLE ANALYZER ...

Page 165: ...e 5 2 These options are used to configure the system according to the laboratory s requirements The function of each key is discussed and set up procedures are given where applicable Figure 5 2 Set Up Menu Screen Set Up Menu When the SET UP key is pressed the following soft key labels are displayed DATE TIME PATIENT LIMITS REAGENT LOG QC SET UP MENU OPERATION SET UP UNITS SELECTION CUSTOMIZE REPOR...

Page 166: ...DATE TIME SET UP screen shown in Figure 5 3 correspond to the following numbered options 1 Display Format selection box 1 Month Day Year 2 Day Month Year 3 Year Month Day 4 Year Day Month 2 DATE entry field 3 TIME entry field The desired format is selected by typing the corresponding number in the entry field displayed to the left of the list 1 When the Enter key on the keyboard is pressed the sel...

Page 167: ...ne or two digits Separate the day month and year year must be 4 digits with a slash or a period The entry order of the date should conform to the date format just selected 5 Press the Enter key on the keyboard to save the entry and advance to the TIME entry field 6 Type the time in the 24 hour military time format using one or two digits For example 00 for 12 midnight 06 for 6 am and 13 for 1 pm S...

Page 168: ...IT SET 1 contains upper and lower limits pre set at the factory The operator shall be able to change these limits Once these limits are changed the operator can return to the factory set limits by either manually inputting the factory set limits or by re installing the Set Up Disk LIMIT SETS 2 through 6 contain zeros for the lower limits and 9s for the upper limits when the instrument is first ins...

Page 169: ...us box and the soft key corresponding to that number is blanked out The other limit sets may be selected by pressing the appropriate soft key 2 Select a Limit Set by pressing the appropriate LIMIT SET soft key 3 To pre assign a Limit Set based on a patient s sex and age enter one of the three Sex codes and press the Enter key The cursor moves to the Years field Enter a number for years and press E...

Page 170: ...essed DELETE ENTRY DIL SHEATH LOG HGB LYSE LOG WBC LYSE LOG PRINT LOG RETURN NOTE The key label for the reagent log displayed in the Status Box is not displayed with the other keys When the REAGENT LOG key is pressed one of the logs is displayed as shown in Figure 5 5 The name of the displayed log is indicated in the Status Box The other two logs may be displayed by pressing the appropriate soft k...

Page 171: ...move the cursor to the desired entry field 4 Type the appropriate information NOTE Entries for each field of information are optional Dates should be entered with a slash or a period separating the month day and year 5 Press the Enter key on the keyboard to save the entry and advance the cursor 6 Repeat steps 3 5 until all desired entries have been made 7 If desired press PRINT LOG to obtain a pri...

Page 172: ...l 1 Press REAGENT LOG to display a REAGENT LOG screen If necessary press a soft key to display the appropriate log 2 Move the cursor to the oldest entry in the log 3 Press DELETE ENTRY The COMPLETE DELETION and RESTORE ENTRY keys are displayed 4 Press COMPLETE DELETION to delete the selected entry 5 If desired a new entry may then be made as described above NOTE New entries may also be made by typ...

Page 173: ...see Figure 5 6 and the following soft key labels X B SET UP LAB ID SET UP QC LIMITS SET UP QC FILE CUSTOMIZE DISPLAY CUSTOMIZE PRINTOUT MAIN This section discusses the procedures that are used to set up the QC files Typically a QC file s is set up then QC Limits are established Therefore the keys in the QC SET UP menu will be discussed in this order Figure 5 7 X B Set Up Screen ...

Page 174: ...amples such as background counts that would bias the calculation but should include at least 95 of the patient results 2 TARGET VALUE The Target Value for X B Analysis is similar to the assay value for a commercial control It is derived from the patient population that is analyzed on the instrument 3 ACTION LIMIT The Action Limit is the acceptable limit of variation around the target value NOTE Th...

Page 175: ...ard to obtain a printout of the entered information 5 Press RETURN to return to the QC SET UP screen QC Limits Menu The QC LIMITS key is used to display the QC MEANS LIMITS ENTRY screen and the following soft key labels RANGE ENTRY and MEANS LIMITS The key alternates between the selections UPDATE FROM FILE LOAD FROM DISK PRINT RETURN QC Limits Entry QC Limits are entered by pressing the QC LIMITS ...

Page 176: ...ess the Enter key on the keyboard to save each entry and advance the cursor to the next entry field 5 Repeat step 4 until all entries have been made 6 If desired press PRINT to obtain a printout of the entered values 7 Press RETURN to save the entries and return to the QC SET UP screen NOTE When the entries are saved by pressing the RETURN soft key the software checks to see if any entries would r...

Page 177: ...d 4 Type the numbers and press the Enter key on the keyboard to save each entry and advance the cursor to the next entry field 5 Repeat step 4 until all entries have been made 6 If desired press PRINT to obtain a printout of the entered values 7 Press RETURN to save the entries and return to the QC SET UP screen NOTE When the entries are saved by pressing the RETURN soft key the software checks to...

Page 178: ...r CANCEL the Update From File command When the CONFIRM UPDATE key is pressed the mean value for each parameter is computed from the values in the file The parameter limits are set as follows WBC PLT RDW and MPV 10 of the computed mean NEU LYM and MONO 40 of the computed mean Remaining Parameters 5 of the computed mean Load From Disk The LOAD FROM DISK key is used to enter the lot number expiration...

Page 179: ... screen 6 Insert the disk containing the assay information for the relevant lot number into the Data Station disk drive NOTE Be certain to carefully check lot numbers Be sure the lot number on the disk matches the lot number that is being put into use If the lot number is included in the filename be sure the disk contains assay information for that lot number 7 Check the status box to be sure the ...

Page 180: ...t key labels are displayed when the SET UP QC FILE key is pressed REPLICATE ID LOT NUMBER The key alternates between the selections TOGGLE ON OFF This key is only present when the cursor is in one of the Westgard Rule Selection fields PRINT RETURN The LOT NUMBER ENTRY and REPLICATE ID ENTRY screens are shown in Figures 5 11 and 5 12 The options available are as follows 1 Lot Number and Expiration ...

Page 181: ...eyboard to move the cursor to the desired QC file 3 Type the desired alphanumeric file name Up to 12 characters may be entered 4 Press the Enter key on the keyboard to save the entry and advance the cursor to the next QC file 5 Use the Arrow keys on the keyboard to move the cursor back into the selected file 6 Press SET UP QC FILE to display the QC FILE SET UP screen Figure 5 11 Lot Number Entry S...

Page 182: ...tion date in the format indicated using one or two digits This is the same format selected on the DATE TIME SET UP screen Separate the digits with a slash or a period 4 Press the Enter key on the keyboard to save the entry and advance the cursor to the Westgard Rule Selection entry fields 5 Use the arrow keys on the keyboard to position the cursor at the desired Westgard Rule 6 Press TOGGLE ON OFF...

Page 183: ...E QC DISPLAY screen and the following key labels are displayed when the CUSTOMIZE DISPLAY key is pressed SELECT PARAMETER STANDARD GROUPS RETURN The screen displays a matrix of 4 rows of parameters that are currently selected in Groups 1 through 4 A list of all available parameters is displayed under the matrix The standard groups which include predetermined parameter sets are identified as follow...

Page 184: ...DYN 3200 System Operator s Manual 9140181H October 2001 Operating Instructions Set Up Instructions Section 5 Figure 5 13 Customize QC Display Screen Figure 5 14 Customize QC Display Screen Showing Standard Groups ...

Page 185: ...on the keyboard to move the cursor to the desired location and press PLACE PARAMETER NOTE When the PLACE PARAMETER key is pressed the selected parameter is displayed in the position indicated by the cursor and the cursor is then advanced to the next parameter in the listing under the matrix 7 Repeat steps 4 6 until all selections have been made 8 If desired press the Print screen key on the keyboa...

Page 186: ... second etc 5 Press the soft key corresponding to the desired parameter group This group is displayed in the position indicated by the cursor 6 Repeat steps 4 and 5 until all desired groups have been selected 7 If desired press the Print screen key on the keyboard to obtain a printout of the configuration 8 Press RETURN to return to the QC SET UP menu screen 9 Repeat this procedure to select stand...

Page 187: ...TOUT screen displays the group of parameters that is currently selected A list of all available parameters is displayed under the group Standard Selection The STANDARD SELECTION key is used to automatically arrange the parameters in predetermined print groups see Figure 5 14 Select Parameter The SELECT PARAMETER PLACE PARAMETER key is used to customize the QC Log printout 1 Select a file from the ...

Page 188: ...location and press PLACE PARAMETER NOTE When the PLACE PARAMETER key is pressed the selected parameter is displayed in the position indicated by the cursor the cursor advances to the next parameter in the list under the printout group and the key label changes back to SELECT PARAMETER 6 Repeat steps 3 5 until all entries have been made 7 If desired press the Print Screen key on the keyboard to obt...

Page 189: ...n to an on line host computer The following soft key labels are displayed when the OPERATION SET UP key is pressed TURN ON RETIC PKG LANGUAGE SELECT COLOR BAR CODE SET UP COMPUTER SET UP RETURN Figure 5 17 Language Selection Screen Language Selection QJOLVK GHIDXOW ODQJXDJH The LANGUAGE SELECTION screen shown in Figure 5 17 will allow the user to select one of the following non English languages f...

Page 190: ...n messages and demographic data it does not effect the measurement process or other functional aspects of the program Pressing the NEXT LANGUAGE soft key will allow the user to scroll through the available languages To Change the Language 1 In the OPERATION SET UP MENU press LANGUAGE 2 Press NEXT LANGUAGE to scroll through the list of languages available on the instrument 3 When the desired langua...

Page 191: ...LOR key is pressed RESTORE PREVIOUS RESTORE DEFAULT RETURN Color Reference Main Body 1 Main screen Main Body 2 Flags Main Body 3 Run mode description Main Body 4 Values below limits Main Body 5 Values above limits Main Body 6 Sequence numbers in Data Log Main Body 7 RBC Histogram New entry before Enter key is pressed Main Body 8 PLT Histogram New entry after Enter key is pressed Title Block Top ce...

Page 192: ...nter key to save the entry and move the cursor to the next position NOTE The one field which cannot be changed is Background for Main body 1 This background must always remain black 4 When all desired changes have been made press RETURN to return to the OPERATION SET UP MENU 5 If the operator changes a color selection then wishes to cancel the change and keep the original setting pressing RESTORE ...

Page 193: ...o Appendix A Bar Codes To Set Up Bar Code 1 From the OPERATION SET UP MENU screen press BAR CODE SET UP to display the BAR CODE SET UP screen 2 Type the number for the type of bar code that will be used 1 Code 39 2 Interleaved 2 of 5 3 CODABAR 4 Code 128 Press the Enter key on the keyboard to save the entry and advance the cursor to the Bar Code Check Digit field 3 Press TOGGLE ON OFF to enable or...

Page 194: ...ormation System or on line computer Instructions for using this option are given after the following description of the soft keys Reinit Interface The REINIT INTERFACE key is used to initialize the RS 232 interface for the displayed transmission configuration after it is entered The interface is automatically initialized whenever the STOP TRANSMISS key is pressed NOTE Refer to the Interface Specif...

Page 195: ...cally transmitted to the LIS for any sample without flagged parameter results 3 Auto transmission of ALERTED graph data When this option is enabled histograms are automatically transmitted to the LIS for any sample with flagged results 4 Auto transmission of NON ALERTED graph data When this option is enabled histograms are automatically transmitted to the LIS for any sample without flagged results...

Page 196: ...P MENU press COMPUTER SET UP to display the COMPUTER SET UP screen 2 For the first five options on the list use the Arrow keys on the keyboard to move the cursor to the desired selection and press TOGGLE ON OFF to enable or disable the selection NOTE The TOGGLE ON OFF key is displayed when the cursor is positioned in any of the first five entry fields 3 For the last five options on the list type t...

Page 197: ...h parameter individually or a set of units may be selected by pressing the appropriate soft key See Figure 5 21 The following soft key labels are displayed when the UNITS SELECTION key is pressed USA UNITS SI UNITS SI MOD UNITS SET1 UNITS SET2 UNITS SELECT UNITS RETURN The units selected by each of the soft keys are shown on the screen display in Figure 5 21 The following table demonstrates how va...

Page 198: ...selections have been made 7 If desired press the Print Screen key on the keyboard to obtain a printout of the selected units 8 Press RETURN to return to the SET UP MENU screen Table 5 1 Report Units Parameter USA SI SI MOD SET1 SET2 Value Units Value Units Value Units Value Units Value Units WBC 5 32 K µL 5 32 g L 5 32 10e9 L 5 32 10e3 µL 53 2 10e2 µL RBC 5 15 M µL 5 15 T L 5 15 10e12 L 5 15 10e6 ...

Page 199: ... for the last entry graphics printer or ticket printer is displayed A brief description of the function of the soft keys is given in this section For ease of explanation the keys are grouped according to the type of printer selected When the TICKET PRINTER key is pressed the following soft key label is also displayed BLANK TICKET PRE PRNTD TICKET The key label alternates between the selections The...

Page 200: ...or any sample with flagged results 2 AUTO PRINT RESULTS FOR NON ALERTED SPECIMENS When this option is enabled a report is automatically printed for any sample without flagged results 3 PRINT GRAPHS FOR ALERTED SPECIMENS ONLY When this option is enabled scatterplots and histograms are printed only for samples with flagged results 4 PRINT PCT PDW RESULTS When this option is enabled the results for P...

Page 201: ...DIFFERENTIAL GRID FOR NON ALERTED SPECIMENS When this option is enabled a grid that can be used to report a manual Differential is printed on the report for any specimen that is not flagged 11 LINE FEEDS PER PAGE FOR GRAPHICS PRINTER 1 to 99 This option is used to select the size of the printed report 12 COLOR PRINTING When this option is enabled a color printout can be obtained on the CELL DYN 32...

Page 202: ... printed with this header The following soft key labels are displayed when the CUSTOMIZE HEADER key is pressed RESTORE HEADER BLANK HEADER CUSTOMIZE DISPLAY CUSTOMIZE PRINTOUT SET UP Restore Header The RESTORE HEADER key is used to restore the header to the previous entry This key is only functional immediately after a new header has been entered Once a new header is entered and the CUSTOMIZE PRIN...

Page 203: ...ld For example if 3 were input in the first field then a maximum of 3 lines will be accepted in the header box The operator may type in 4 lines of data but only the first three lines will be saved when the operator exists this screen Existing information may be typed over or an existing header may be deleted by pressing the BLANK HEADER key NOTE The numbers displayed above the header box on the sc...

Page 204: ...TO PRINT RESULTS FOR ALERTED SPECIMENS When this option is enabled a ticket is automatically printed for any sample with flagged results Flagged results are indicated by the letters AL for alert on the printout when the PRINT SPECIFIC ALERTS option is turned OFF see number 6 below Results that exceed Patient Limits are underlined on the printout 3 AUTO PRINT RESULTS FOR NON ALERTED SPECIMENS When ...

Page 205: ...p of the header can be used to center the header information on the ticket Centering the information under the number 2 centers it on the ticket To Customize a Blank Ticket 1 If the Blank Ticket section of the CUSTOMIZE PRINTED REPORT screen is not displayed press BLANK TICKET 2 Use the Arrow keys on the keyboard to move the cursor to the desired selection 3 Press TOGGLE ON OFF to enable or disabl...

Page 206: ...eader on the printed page Each line can be positioned independently Use the Space Bar on the keyboard to position the cursor for typing 9 If desired press the Print Screen key on the keyboard to obtain a printout of the selections 10 Press SET UP to return to the SET UP MENU screen Figure 5 25 Customize Printed Report Screen for Pre Printed Tickets Pre Printed Tickets When the PRE PRNTD TICKET key...

Page 207: ... REPORT screen refer to Figure 5 25 2 Use the arrow keys on the keyboard to move the cursor to the desired option 3 Press TOGGLE ON OFF to enable or disable the selected option 4 Repeat steps 2 and 3 until all selections have been made 5 If desired press the Print Screen key on the keyboard to obtain a printout of the selections 6 Press SET UP to return to the SET UP MENU screen Customize Displaye...

Page 208: ...ed in the right section Parameter Sets Using the PARAM SET X key the display may be customized for four different sets of parameters Up to 20 individual parameters and up to four scatterplots and or histograms may be displayed in each set The Empty selection at the bottom of the Histogram list may be used to blank the scatterplot or histogram display at the selected position Move the cursor to Emp...

Page 209: ...de of the screen 5 Repeat steps 3 and 4 until all parameter selections have been made Use the Right Arrow key to move the cursor to the next section 6 Use the Arrow keys to move the cursor to the desired scatterplot or histogram 7 Press SELECT GRAPH to select it The scatterplot or histogram name is highlighted and the cursor moves to a display position The key label changes to PLACE GRAPH and the ...

Page 210: ...nia result exceeds the lower limit for Lymphocyte absolute number Lymphocytosis result exceeds the upper limit for Lymphocyte absolute number Monocytosis result exceeds the upper limit for Monocyte absolute number Eosinophilia result exceeds the upper limit for Eosinophil absolute number Basophilia result exceeds the upper limit for Basophil absolute number RBC Messages Anemia result exceeds the l...

Page 211: ...nd to Appendix A for information on the use of bar code labels Power ON Procedure The System power switch on the back of the Analyzer should be left ON at all times The instrument has been designed to automatically maintain itself when it is idle If the instrument is idle for four hours an automatic Shutdown cycle is initiated The instrument is placed in the STANDBY state at the end of the automat...

Page 212: ...m initialization refers to the automatic process that occurs when the instrument is first turned ON or after certain problems have been corrected and the instrument must again be brought to the READY state Initialization is a two step process 1 Initializing the hardware and software 2 Priming the system with reagents The system is initialized when the Analyzer is turned ON or when the INITIALIZATI...

Page 213: ... again to start a new RUN cycle The SL model in Open Mode automatically halts after each sample has been processed unless the Touch Plate is pressed again to start a new RUN cycle The SL model in Closed Mode automatically halts when no more racks are detected on the load side and the last track has passed under the Tower to the Unload side Emergency Stops To immediately halt all operation of the i...

Page 214: ...re in the SPECIAL PROTOCOLS menu If necessary refer to Section 9 Service and Maintenance Subsection Daily Maintenance Procedures 3 When the Auto Clean cycle is finished press DAILY SHUTDOWN When the Daily Shutdown cycle is finished the message STANDBY will be displayed in the Status Box 4 Turn the power switches OFF in the following order a System includes Analyzer Data Module and Sample Loader b ...

Page 215: ... consists of the following procedures 1 Check the reagent levels and replace reagent containers as necessary 2 Check printer paper add more paper as necessary 3 Check tubing in the Normally Closed Valves and Sample Transfer Peristaltic Pump for breaks crimps or other obstructions 4 Run background counts until acceptable results are obtained for all background parameters WBC RBC HGB and PLT Accepta...

Page 216: ...5 64 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Operating Instructions Start Up Procedure Section 5 NOTES ...

Page 217: ... used to enter patient identification information such as a Social Security number Up to 16 characters may be entered SEX used to enter the sex of the patient DOB used to enter the date of birth of the patient 4 digits must be entered for the Year COL used to enter the collection date and time of the specimen 4 digits must be entered for the Year DR used to enter the name of the patient s physicia...

Page 218: ... example XX 120 current number of specimens in a batch of 120 applies only to QC Specimens Param Set indicates the Parameter Set applied to the results run in the QC file For BACKGROUND and LATEX the default Param Set is 1 Status Box The Status Box is displayed in the Top Center of the RUN screen It contains the following information Menu in use The Status of the Analyzer the READY NOT READY and F...

Page 219: ... Bulletin Line is displayed immediately above the key labels Messages appear in this line to identify status or fault conditions Run Menu Soft Keys CS Model Figure 5 27 Run Screen for Patient Samples CS Model The soft keys displayed at the bottom of the RUN menu are used to access the menu options that are available The soft keys displayed on the SL model are slightly different from the keys displ...

Page 220: ...e SL model are similar to the CS model except for the first key leftmost key label on the screen in Closed Mode shown below which is used to operate the Sample Loader See Figure 5 28 START LOADER STOP LOADER This key label alternates between the selections If a fault occurs this key label changes to CLEAR FAULT similar to the CS model Soft Key Description A brief description of the function of eac...

Page 221: ...corrective action has been taken NOTE A message describing the fault appears in the bulletin line A list of fault conditions and corrective action is given in Section 10 Troubleshooting and Diagnostics Work List This key is used to display the WORK LIST screen shown in Figures 5 29 and 5 30 Use the left and right arrow keys to scroll between the pages When the WORK LIST key is pressed the WORK LIS...

Page 222: ... run It is essentially a list of samples including the pre assigned information that the operator intends to run on the instrument The Work List may be used with or without bar code labels on the tubes However if bar codes are used on the tubes they must contain more than two digits to avoid a possible mis reading of the 2 digit bar code assigned to each rack For a detailed discussion of the Work ...

Page 223: ...e screen displays a list of the QC files and the following soft key labels PATIENT QC SPECIMEN BACKGROUND FRAGILE WBC LATEX RESISTANT RBC RETURN The function of each key is discussed below Selecting a Specimen Type Most samples will be run in the Patient mode If a FWBC or RRBC flag is displayed on the 581 screen the presence of fragile WBCs or resistant RBCs is suspected Depending on the flag sele...

Page 224: ...tion 5 Patient Figure 5 32 Run Screen Showing Patient Results The PATIENT key is used to display the RUN screen for patient samples See Figure 5 32 Patient identification and demographics may be entered on the RUN screen after this key is pressed Results from this run option are stored in the Data Log ...

Page 225: ...e screen Refer to Figure 5 31 for a display of QC files After the cursor is moved to the desired file the QC SPECIMEN key is pressed to display the 581 screen for the selected file Refer to Figure 5 33 Results from this run option are stored in the selected file and in the Data Log NOTE The selected QC file is identified in the upper left section of the screen and is also identified in the Status ...

Page 226: ...ackground Figure 5 34 Run Screen for Background Counts The BACKGROUND key is used to select the run mode and display the RUN screen for background counts Refer to Figure 5 34 Results from this run option are identified by the designation 5281 in the Data Log and are automatically excluded from the X B analysis ...

Page 227: ...is used to obtain an accurate WBC count for samples containing fragile WBCs After HGB has been measured the diluted HGB sample is sent to the Optical Flow Cell instead of the Waste System where the nuclei of the lysed white cells are counted This count is referred to as the Nuclear Optical Count NOC The Fragile WBC screen refer to Figure 5 35 is similar to the Patient screen except that FrgWBC rep...

Page 228: ...Figure 5 36 Run Screen for Latex Counts The LATEX key is used to select the run mode for latex particles and display the RUN screen for them The LATEX screen is similar to the QC FILE screen except that Latex replaces the QC File name in the Demographics Section This key is for use by Abbott service personnel only ...

Page 229: ... The sample is held in the WBC Mixing Chamber for approximately 15 seconds longer than the normal mixing time The extra time enhances the osmotic lysing effect of the WBC lyse and reduces interference from the lyse resistant RBCs The interference caused by these RBCs frequently generates WBC and Differential flags The Resistant RBC mode reduces the number of flags generated The RESISTANT RBC scree...

Page 230: ...y clear any patient information entered in the demographics section of the RUN screen Print Ticket The PRINT TICKET key is used to print a report on a ticket when a printer is connected to the Ticket Printer Port on the Data Module The report is printed on the type of ticket that is selected from the CUSTOMIZE PRINTED REPORT screen Print Report The PRINT REPORT key is used to print a graphics repo...

Page 231: ...s Additional Examples of Run Menu Screens Flagging Messages An example of some flagging messages is shown in Figure 5 38 A detailed explanation of all flagging messages is given in Section 3 Principles of Operation Figure 5 38 Display Specimen Screen Showing Flagging Messages and RBC MORPH Message ...

Page 232: ...nu Section 5 Bulletin Line Messages Bulletin Line messages alert the operator to problems with the instrument or provide instructions An example of a Bulletin Line message reading Ticket printer unavailable is shown in Figure 5 39 Figure 5 39 Display Specimen Screen Showing Bulletin Line Message ...

Page 233: ...LABORATORY WORKSHEET screen press the Page Down key on the keyboard while the RUN menu is displayed or while the DISPLAY SPECIMEN screen in the DATA LOG menu is displayed The LABORATORY WORKSHEET screen displays additional parameters as shown in Figure 5 40 This screen is for laboratory use only Figure 5 40 Laboratory Worksheet Screen ...

Page 234: ...5 82 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Operating Instructions Run Menu Section 5 NOTES ...

Page 235: ...n samples processed less than 30 minutes or more than 4 hours after collection time The stability of capillary samples collected in microtainers may vary depending on the microtainer manufacturer Refer to the manufacturer s package insert for stability claims Sample Collection All samples should be collected using proper technique and following the tube manufacturer s recommendations NOTE For addi...

Page 236: ...ulin and cryofibrinogen fragile WBCs RBC Elevated WBC count increased numbers of giant PLTs autoagglutination in vitro hemolysis HGB Elevated WBC count increased plasma substances triglycerides bilirubin in vivo hemolysis lytic resistant RBCs MCV Elevated WBC count hyperglycemia in vitro hemolysis increased numbers of giant PLTs PLT WBC fragments in vitro hemolysis microcytic RBCs cryoglobulins PL...

Page 237: ...o select one of these three specimen types do the following 1 Go to the RUN menu and press SPECIMEN TYPE 2 Press one of the following keys to select the desired specimen type PATIENT FRAGILE WBC RESISTANT RBC Enter the sample identification information as follows 1 A Sample ID number Next ID field of up to 12 characters may be entered in the NEXT ID entry field 2 The remaining patient demographic ...

Page 238: ...losed mode CS Model or Open mode must be well mixed on a mechanical mixer or hand mixed by inversion per your laboratory s protocol Immediately prior to sample aspiration mix again by inverting the tube a minimum of 5 times For specimens collected in micro collection devices refer to the manufacturer s insert for proper mixing and handling WARNING Potential Biohazard Consider all specimens reagent...

Page 239: ...handling instructions The Sample Loader automatically mixes the samples immediately before aspiration Instrument Preparation 1 Be sure that the green READY light on the Analyzer Status Indicator Panel is illuminated and the READY message is displayed in the Status Box on the 581 screen 2 If the Status Box on the Data Station RUN screen displays STANDBY or INITIALIZED press RUN to initiate the auto...

Page 240: ...l specimens and reagents controls calibrators etc that contain human blood or serum as potentially infectious Wear gloves lab coats and safety glasses and follow other biosafety practices as specified in the OSHA Bloodborne Pathogen Rule 29 CFR Part 1910 1030 or other equivalent biosafety procedures Open Mode QC Procedure 1 In the RUN screen press SPECIMEN TYPE 2 Move the cursor to the desired QC ...

Page 241: ... QUALITY CONTROL 12 Use the Arrow keys on the keyboard to move the cursor to the desired file 13 Press VIEW QC LOG to display the QC LOG screen 14 Verify that the results are acceptable NOTE Out of range results are displayed in color 15 Press RETURN to return to the main QUALITY CONTROL screen 16 Repeat steps 12 15 for all levels of controls that were run 17 If the results are unacceptable repeat...

Page 242: ...e cycle The yellow BUSY light on the Analyzer Status Indicator Panel is illuminated The Status Box on the 581 screen displays messages to indicate the various stages of the cycle 6 Remove the tube when the beep sounds The message REMOVE SPECIMEN is displayed in the Status Box The wash block moves down the probe and cleans it 7 When the cycle is finished the wash block moves up the probe the green ...

Page 243: ...us Box on the RUN screen 3 Place the well mixed samples in the Sample Loader racks NOTE The racks and tube positions are identified by the bar code label on the rack and indicated as RxTx These numbers appear as the Sample ID number if bar code labels are not used If the Work List is used the Sample ID number is taken from it Refer to Using the Work List later in this section for more information ...

Page 244: ...5 92 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Operating Instructions Sample Analysis on the CELL DYN 3200SL Section 5 NOTES ...

Page 245: ...le 3 When the cycle is finished a background count is automatically performed and the Open Mode is selected 4 Verify that the background counts are acceptable If the background counts are unacceptable repeat the background cycle If the counts are still unacceptable troubleshoot accordingly NOTE Backgrounds may be repeated by pressing the touch plate 5 If controls will be processed in Closed Mode p...

Page 246: ...unning Samples WARNING Potential Biohazard Consider all specimens and reagents controls calibrators etc that contain human blood or serum as potentially infectious Wear gloves lab coats and safety glasses and follow other biosafety practices as specified in the OSHA Bloodborne Pathogen Rule 29 CFR Part 1910 1030 or other equivalent biosafety procedures Open Mode Analysis The Open Sampler mode aspi...

Page 247: ...tus Box on the screen Generally the READY light on the Analyzer Status Indicator Panel will be illuminated before the Status Box on the screen displays READY 8 If automatic report printing has been specified a report is printed according to the options selected during Set Up The reports are printed in black and white If automatic printing has not been specified a report may be printed by pressing ...

Page 248: ...nel is illuminated 6 Remove the tube when the door opens A beep sounds when the door opens NOTE The door automatically opens whenever a sample has been aspirated in the Closed Mode or a background count has been run in Open Mode There is also a tab under the Door Assembly that mechanically releases the door This tab can be used if the door is closed and no tube is in the holder The door will not o...

Page 249: ...e are indicated by in place of the result Fault Conditions The CLEAR FAULT key is displayed and a message e g DILUENT EMPTY appears in the Status Box if a fault condition is detected The word Fault on the Analyzer status indicator is illuminated in red The Status Box displays the message FAULT SEE DIAG or SEE SPECIAL to direct the operator to the DIAGNOSTICS or SPECIAL PROTOCOLS menu for further i...

Page 250: ...RS 3 3 CONSECUTIVE NOC FLOW ERRORS Sampling Errors The message SAMPLING ERROR INCOMPLETE ASPIRATION is displayed on the Bulletin line if insufficient sample was detected during aspiration SAMPLING ERR is displayed on the screen and SAMPLING ERR is printed on the graphics report to the right of the MCHC The same message is printed to the right of the WBC on the pre printed ticket and printed above ...

Page 251: ...inched tubing is set The Daily Shutdown cycle takes approximately 10 minutes For a more thorough cleaning of the instrument prior to Daily Shutdown perform the following procedures 1 In the SPECIAL PROTOCOLS menu press AUTO CLEAN 2 Clean Sample Loader including racks and Tower Cover 3 Press DAILY SHUTDOWN 4 Leave Power ON 5 Empty Waste as needed NOTE The Auto Clean cycle may be run as part of the ...

Page 252: ... is to be cleaned first press AUTO CLEAN otherwise go to step 3 3 Press DAILY SHUTDOWN 4 Leave power ON 5 Tubing should be removed from under the Peristaltic Pump Intermediate term Shutdown If the shutdown time is expected to exceed 72 hours but less than 2 weeks follow the procedure below 1 With the system still ON perform any maintenance that is due 2 In the MAIN MENU press SPECIAL PROTOCOLS 3 P...

Page 253: ...Normally Closed Valves on the Flow Panel refer to Figure 1 5 Tubing under the Peristaltic Pump 6 Record this maintenance in your maintenance log CAUTION Do not forget to reinsert the tubing securely in the Normally Closed Valves and under the peristaltic pump before turning the instrument back ON Refer to Section 2 Installation Procedures and Special Requirements Subsection Tubing Installation For...

Page 254: ...5 102 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Operating Instructions Daily Shutdown Procedure Section 5 NOTES ...

Page 255: ...by the operator 4 Work List records with other sample identification non Bar Code in the Specimen ID field are entered at the instrument by the operator As samples are processed the Work List is accessed If the identifying information on the sample such as a bar code number matches the identifying information of an entry in the Work List then a match has occurred and that entry is removed from the...

Page 256: ... Mode if necessary 4 Press SPECIMEN TYPE followed by the appropriate specimen type Patient Fragile WBC or Resistant RBC 5 Press START LOADER to begin processing 6 When processing is finished verify that all entries have been deleted from the Work List indicating that all samples were successfully matched to their corresponding entries CS Model If the instrument is the CS model and bar codes are us...

Page 257: ...ssed 7 If the operator types in a bar code number or non bar code Specimen ID into the Specimen ID field on the RUN screen and presses the Return key the system immediately searches the Work List for a matching entry If a match is found the demographic information is displayed on the RUN screen NOTE This feature is not possible on the SL model Closed Mode because the operator cannot input data to ...

Page 258: ...t reads the bar code on the rack and keeps track of each tube position If a match occurs that entry is removed from the Work List The results of that sample along with its demographic data are displayed on the RUN screen and stored in the Data Log If a sample cannot be matched with any of the entries in the Work List no entries are deleted from the Work List The results of that sample are displaye...

Page 259: ... Work List entries are matched using one of the following two methods 1 Bar Codes entered into the Next ID field of the RUN screen by the operator 2 Non Bar Code Specimen IDs entered into the Next ID field on the RUN screen by the operator CS Model Open Mode In the CS Open Mode the Work List is searched as soon as the operator enters a bar code number or non bar code Specimen ID in the Next ID fie...

Page 260: ...5 108 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Operating Instructions Using The Work List Section 5 Figure 5 41 Work List Screen Page 1 Figure 5 42 Work List Screen Page 2 ...

Page 261: ... Specimen ID field To place the cursor in the Rack and Tube field the operator must use the left arrow key to move the cursor from the Specimen ID field to the Rack and Tube field 3 SPECIMEN ID The specimen identification must consist of either a Bar Code number or other Specimen ID Up to 12 characters may be entered The sample is identified on the 581 screen in the Data Log and on the printed rep...

Page 262: ...field is used to enter the number of the Parameter Set that will be used for the sample If no entry is made the default pre selected Parameter Set is used Work List Soft Keys The function of each of the soft keys displayed on the WORK LIST screen is discussed below Insert Delete When the INSERT DELETE key is pressed the following soft key labels are displayed INSERT DELETE RETURN Insert The INSERT...

Page 263: ... CANCEL the Delete All command Work List Set Up Refer to Work List Set Up Procedure below for a discussion of the WORK LIST SET UP screen and options Print Work List The PRINT WORK LIST key is used to print the Work List Return The RETURN key is used to return to the RUN screen Work List Set Up Procedure The WORK LIST SET UP key is used to display the WORK LIST SET UP screen shown in Figure 5 43 F...

Page 264: ...ys to move the cursor to an OFF field and input data Pressing the Enter key saves the data and moves the cursor to the next ON field Number Fields The system will accept any number in the range 1 to 6 for Patient Limits and 1 to 4 for Parameter Set The number selected for either field serves as the default for that field for subsequent entries and is independent of whether that field is ON or OFF ...

Page 265: ...ace the cursor in this field and enter data if desired 5 COLLECTION DATE AND TIME ENTRY SELECTED This field is used to specify whether or not the collection date and time of the specimen will be entered into the Work List If this option is turned OFF the cursor will skip to the next ON field However the operator can use the arrow keys to place the cursor in this field and enter data if desired 6 D...

Page 266: ... to place the cursor in this field and type in a new setting The new setting applies only to the entry ies that was changed If this option is turned ON the operator may then select another default setting by typing in a number from 2 to 4 This new setting will be automatically assigned to each new entry The operator also has the ability to enter a different setting for individual entries When the ...

Page 267: ...or that bar code number If a match is found the demographic data from the Work List is displayed on the RUN screen along with the results and the entire record is stored in the Data Log The Work List entry is deleted If no match occurs the Bar Code number is displayed on the RUN screen without demographic data and stored in the Data Log along with the results No Work List entry is deleted Running ...

Page 268: ...he Work List but the position of each sample in the racks must match its Rack and Tube in the Work List Sample identification is made from the information entered in the Rack and Tube 6th field on the Work List If a match occurs based on the Rack and Tube the sample results along with the demographic data including the Specimen ID are displayed on the RUN screen and sent to the Data Log NOTE The R...

Page 269: ...the sample into the appropriate rack and tube position DOUBLE CHECK to ensure the sample was actually placed in the rack and tube position indicated in the Work List entry NOTE The samples in the racks do not have to be in the same order as the Work List entries but the actual rack and tube number of each sample must be correctly assigned to the Work List entry for that sample a Repeat this proces...

Page 270: ...st by the operator 4 STAT samples are processed in the same manner as other Work List samples Refer to Running Samples with Bar Codes and Running Samples with Specimen IDs discussed earlier in this section Open Mode Using the Work List with Bar Codes If Work List entries with Bar Codes have been downloaded from a host the operator must type the bar code number into the Next ID field on the RUN scr...

Page 271: ...g the Specimen ID on the sample tube into the Next ID field on the RUN screen The instrument will attempt to match the number in the Next ID field on the RUN screen with the same number in the Specimen ID field in the Work List If a match occurs and the sample is processed the results along with the demographic data from the Work List will be displayed on the RUN screen and sent to the Data Log Th...

Page 272: ...or serum as potentially infectious Wear gloves lab coats and safety glasses and follow other biosafety practices as specified in the OSHA Bloodborne Pathogen Rule 29 CFR Part 1910 1030 or other equivalent biosafety procedures Closed Mode Using the Work List with Bar Codes The Closed Sample Aspiration Tower has a built in Bar Code Reader that automatically reads a bar code label placed on the tube ...

Page 273: ...t the instrument perform steps a through h below a In the RUN screen press SPECIMEN TYPE followed by the appropriate specimen type Patient Fragile WBC or Resistant RBC b If necessary press CHANGE SAMPLER to select the Closed Mode c Be sure that each sample to be run has a bar code label on the tube d Enter all the Work List records associated with the samples to be run into the Work List DOUBLE CH...

Page 274: ...cords including demographic data and Specimen ID associated with the samples to be run DOUBLE CHECK to ensure that each Specimen ID was entered correctly in the Specimen ID field 5 Select a sample tube and type the Specimen ID shown on the tube into the Next ID field on the RUN screen 6 Place a well mixed sample in the Tube Retainer and close the door 7 Press the Touch Plate to run the sample 8 Wh...

Page 275: ...n Mode on the CS model in the same manner as on the SL model For a description of this procedure refer to Sample Analysis SL Model Subsection Open Mode Analysis STAT Samples STAT samples are processed in the Open Mode on the CS model in the same manner as on the SL model For a description of this procedure refer to Sample Analysis SL Model Subsection Open Mode Analysis ...

Page 276: ...5 124 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Operating Instructions Using The Work List Section 5 NOTES ...

Page 277: ...olling Through the Data Log Each screen display page may contain up to 18 specimens Use the Left and Right Arrow keys to scroll through the complete list of parameters for all specimens displayed on a page Use the Up and Down Arrow keys to move the cursor between specimens on a page Use the Page Up key to scroll through preceding pages Use the Page Down key to scroll through succeeding pages DATA ...

Page 278: ...e DATA LOG menu and the following soft key labels are displayed EDIT ID DISPLAY SPECIMEN FIND SPECIMEN REJECT FROM X B CUSTOMIZE DATA LOG TRANSMIT DATA PRINT DATA LOG MAIN This key is displayed only if the cursor is positioned next to one of the following patient record types Patient Fragile WBC and Resistant RBC This key is displayed if the sequence number of the patient record is preceded by a b...

Page 279: ...Specimen Screen Display Specimen The DISPLAY SPECIMEN key is used to display the results for the record indicated by the cursor position See Figure 5 45 The following soft key labels are displayed when the DISPLAY SPECIMEN key is pressed PREVIOUS SPECIMEN NEXT SPECIMEN EDIT SPECIMEN CUSTOMIZE REPORT TRANSMIT SPECIMEN PRINT TICKET PRINT REPORT COLOR PRINT The key label alternates between the select...

Page 280: ...IRM or CANCEL the edits The Bulletin line displays the message PRESS CONFIRM TO SAVE CHANGES OR CANCEL TO CANCEL CHANGES When the CONFIRM key is pressed the edited record is displayed Customize Report The CUSTOMIZE REPORT key is used to customize the RUN screen display header and printout as described in the Set Up Instructions section of this chapter Transmit Specimen The TRANSMIT SPECIMEN key is...

Page 281: ...nd Specimen The FIND SPECIMEN key is used to locate a particular record by entering the Sequence number Specimen ID number or Patient Name for the desired record When this key is pressed the DATA LOG SEARCH screen is displayed See Figure 5 46 If the record is not found in the Data Log the Bulletin line displays the message NO ENTRY FOUND ...

Page 282: ... analysis the REJECT FROM X B key label is displayed See Figure 5 47 Figure 5 47 Data Log Screen Showing Reject From X B Key When the REJECT FROM X B key is pressed the sample is marked with an R following the Specimen ID the results are excluded from the X B analysis the R w or b is deleted and the key label changes to ACCEPT INTO X B See Figure 5 48 If the ACCEPT INTO X B key is pressed the R is...

Page 283: ...CELL DYN 3200 System Operator s Manual 5 131 9140181H October 2001 Section 5 Operating Instructions Figure 5 48 Data Log Screen Showing Accept Into X B Key ...

Page 284: ...STOM PLACEMENT The key alternates between the selections CUSTOMIZE PRINTOUT RETURN Figure 5 49 Customize Display for Data Log Screen Showing Standard Groups The CUSTOMIZE DISPLAY FOR DATA LOG screen displays a matrix showing the four parameter groups and a list of the available parameters Parameter Group 1 is displayed in the order indicated from left to right on the second DATA LOG screen The rem...

Page 285: ...d to select a parameter designated by the cursor When the key is pressed the selected parameter is highlighted the label changes to PLACE PARAMETER and a CANCEL SELECTION key is displayed Place Parameter The PLACE PARAMETER key is used to display the parameter in the location indicated by the position of the cursor Cancel Selection The CANCEL SELECTION key is used to cancel the selection and displ...

Page 286: ...y labels are displayed when the STANDARD GROUPS key is pressed WBC GROUP RBC GROUP PLT GROUP DIFF GROUP CUSTOM PLACEMENT CUSTOMIZE PRINTOUT RETURN The CUSTOM PLACEMENT key is used to return to the CUSTOMIZE DISPLAY FOR DATA LOG screen for operator selected placement Figure 5 49 shows the WBC Group placed in GROUP 1 the RBC Group placed in GROUP 2 the PLT Group placed in GROUP 3 and the Diff Group ...

Page 287: ...rameter The SELECT PARAMETER key is used to select a parameter designated by the cursor When the key is pressed the selected parameter is highlighted the label changes to PLACE PARAMETER and a CANCEL SELECTION key is displayed Place Parameter The PLACE PARAMETER key is used to display the parameter in the location indicated by the position of the cursor Cancel Selection The CANCEL SELECTION key is...

Page 288: ...ly the summary data of these records will be transmitted No histogram data accompanies the summary data Print Data Log The PRINT DATA LOG key is used to print the Data Log When the PRINT DATA LOG key is pressed the screen prompts the operator to enter the starting and ending sequence numbers from the lowest to the highest for the desired printout See Figure 5 52 When the PRINT DATA LOG key is pres...

Page 289: ...tely preceding the date see Figure 5 52 These codes are displayed in the following order O Sample was run in the Open Mode C Sample was run in the Closed Mode N Incomplete aspiration in the Open Mode I Incomplete aspiration in the Closed Mode K Flow Error R Resistant RBC key was used to run this sample F Fragile WBC key was used to run this sample NOTE For Background and Latex specimens only the O...

Page 290: ... order selected by the operator This section gives instructions for Customizing the Display and Printout Customizing the Data Log Display The CUSTOMIZE DISPLAY FOR DATA LOG screen displays a matrix showing the four groups of parameters that will be consecutively displayed on the four Data Log screens Figure 5 54 shows the Standard Groups in the matrix A list of all available parameters is displaye...

Page 291: ... CUSTOMIZE DISPLAY FOR DATA LOG screen 2 If necessary press CUSTOM PLACEMENT to display the CUSTOMIZE DISPLAY FOR DATA LOG screen and key labels for custom placement 3 Use the Arrow keys on the keyboard to move the cursor to the desired parameter in the listing under the matrix 4 Press SELECT PARAMETER The selected parameter is highlighted and the cursor moves to the first position in Group 1 NOTE...

Page 292: ...ta Log Display for Standard Groups 1 From the main DATA LOG screen press CUSTOMIZE DATA LOG to display the CUSTOMIZE DISPLAY FOR DATA LOG screen 2 Press STANDARD GROUPS to display the CUSTOMIZE DISPLAY FOR DATA LOG screen and key labels for Standard Groups 3 Use the Arrow keys on the keyboard to move the cursor to the desired group 1 4 location NOTE This number indicates the order in which the gro...

Page 293: ...E PRINTOUT FOR DATA LOG screen see Figure 5 55 shows the group of parameters that will be printed on a Data Log printout A list of the available parameters is displayed under the group The parameters are selected from the list and placed in the desired position to customize the printout In addition to the usual Hematologic parameters the following parameter may also be printed in the Data Log NOC ...

Page 294: ...ACE PARAMETER and a CANCEL SELECTION key is displayed 4 If necessary use the Arrow keys on the keyboard to move the cursor to the desired location and press PLACE PARAMETER NOTE When the PLACE PARAMETER key is pressed the selected parameter is displayed in the position indicated by the cursor and the cursor then advances to the next parameter in the list displayed under the printout group 5 Repeat...

Page 295: ...ecord is displayed on the DISPLAY SPECIMEN screen See Figure 5 56 Figure 5 56 Display Specimen Screen To Display a Record 1 From the MAIN MENU screen press DATA LOG 2 Use the Arrow keys on the keyboard to move the cursor to the desired record use the Page Up and Page Down keys to scroll between pages 3 Press DISPLAY SPECIMEN to display the RUN screen for the selected record 4 If desired press PRIN...

Page 296: ...he Arrow keys on the keyboard to move the cursor to the desired identifier Sequence Number Specimen ID Number or Name Refer to Figure 5 57 4 Type the appropriate information and press the Enter key on the keyboard to start the search NOTE If necessary you may press the Escape ESC key or the Enter key on the keyboard to exit from the search function and return to the DATA LOG screen 5 If the reques...

Page 297: ...creen To Edit a Specimen 1 From the MAIN MENU screen press DATA LOG 2 Locate the desired record and press DISPLAY SPECIMEN followed by EDIT SPECIMEN 3 Use the Arrow keys on the keyboard to move the cursor to the line that will be edited and type the appropriate information Press the Enter key on the keyboard to save the entry 4 Press CONFIRM to display the RUN screen for the edited result 5 If des...

Page 298: ...e for the Collection of Diagnostic Blood Specimens by Venipuncture Third Edition Approved Standard 1991 2 NCCLS Standard H4 A3 Procedure for the Collection of Diagnostic Blood Specimens by Skin Puncture Third Edition Approved Standard 1991 3 ICSH Protocol for Evaluation of Automated Blood Cell Counters Clinical and Laboratory Hematology 1988 10 203 212 ...

Page 299: ...sured parameters WOC NOC RBC HGB MCV PLT and MPV may be calibrated Calibration should be confirmed on a regular basis according to the laboratory s schedule for maintaining good laboratory practice On board quality control programs are designed to provide continual monitoring and verification of instrument calibration The laboratory should make the decision to recalibrate based on the performance ...

Page 300: ...6 2 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Calibration Procedures Overview Section 6 NOTES ...

Page 301: ...o Calibration Enter Factor and Latex 1 The Auto Calibration method is designed to quickly and easily calibrate the system using commercial control material or fresh whole blood a On the CS model Auto Calibration can be used in both the Open and Closed Modes b On the SL model Auto Calibration can be used only in the Open Mode The Enter Factor Method must be used to calibrate the Closed Mode 2 The E...

Page 302: ...es 1 statistical computations and Westgard Rules for commercial or patient controls and 2 monitoring of patient samples for WBC parameters with moving averages and RBC parameters using Bull s Moving Average Program X B The laboratory should make the decision to recalibrate based on the results of the instrument s performance as indicated by these quality control programs However calibration should...

Page 303: ...es The Auto Cal method uses one sample to calibrate compared to the Enter Factor method which uses five samples Reference values are obtained by running the sample s on a reference instrument using acceptable reference methodology and calculating the mean reference value for each parameter The same sample s used to calibrate should also be used to confirm calibration Latex Latex is used to calibra...

Page 304: ...6 6 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Calibration Procedures General Information Section 6 NOTES ...

Page 305: ... recommended CELL DYN reagents 3 Verify the precision for the Open and Closed Modes prior to calibration as directed in the Pre Calibration Procedures Checklist NOTE If necessary refer to the directions for customizing the display and printout of a QC file given in Section 5 Operating Instructions Subsection Set Up Instructions 4 Select and process all whole blood samples according to the requirem...

Page 306: ...Closed Mode Enter Factor Method The calibrator should be cycled for a minimum of 6 consecutive runs Additional samples and or repetitions of the specimens may be used to achieve calibration accuracy beyond NCCLS recommendations The Calibrator sample should contain a minimum of 5 0 mL If necessary aliquot a sufficient amount of sample into a single tube for Closed Mode processing Fresh Whole Blood ...

Page 307: ...ne fresh whole blood sample is used in Auto Cal it is important that a representative sample be selected to calibrate the instrument A sample containing abnormalities may adversely affect calibration Number of Cycles Samples should be assayed first on a reference instrument or by reference methodology and then on the CELL DYN 3200 Auto Cal Method A single fresh whole blood sample should be cycled ...

Page 308: ...ound counts are within the acceptable limits Record the background counts below or attach a printout to this document WOC 0 10 ________ NOC 0 10 ________ RBC 0 02 ________ HGB 0 10 ________ PLT 5 0 ________ 6 _______ Verify the Open Mode precision by analyzing a fresh normal whole blood sample 10 times in succession Select an empty QC file in the SPECIMEN TYPE menu Make sure Open Mode is selected ...

Page 309: ... a minimum of 1 mL of sample containing no anticoagulant Select an empty QC file in the SPECIMEN TYPE menu Make sure Closed Mode is selected Place the tubes in a rack place the rack in the loading position and press the START LOADER key c When all the samples have been processed on either the CS or SL model record the CVs below or attach a file printout to this document PARAMETER CV LIMIT CV WOC 2...

Page 310: ..._______________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ____...

Page 311: ...1 displays the calibration factors for the Open Mode and Figure 6 2 displays the calibration factors for the Closed Mode Note that Open Sampler is displayed in both figures indicating Open Mode The mode is independent of the calibration factors being displayed The following soft key labels are displayed ENTER FACTOR CALIBRATION LOG AUTO CALIBRATE OPEN SAMPLER CLOSED SAMPLER Key label alternates be...

Page 312: ...6 14 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Calibration Procedures Calibration Menu Section 6 Figure 6 2 Calibration Menu Screen Displaying Closed Sampler Calibration Factors ...

Page 313: ...ode refer to Figure 6 3 The soft keys available in this screen are RESTORE FACTORS RESET ALL TO 1 000 RETURN Restore Factors The RESTORE FACTORS key is used to restore the previous calibration factors This key is active only immediately after factors have been changed Reset all to 1 000 The RESET ALL TO 1 000 key is used to reset all of the calibration factors to 1 000 Return The RETURN key is use...

Page 314: ...ded to the bottom of the list Therefore the log should be printed periodically for purposes of documentation The log displays the DATE TIME OPERATOR ID CALIBRATION FACTORS and a line for COMMENTS NOTE The letters in parentheses after each factor indicate the method of factor derivation F Factory A Auto Cal E Enter Factor manual factor entry Type any comments in the COMMENTS field Press the Enter k...

Page 315: ...CALIBRATE key is used to display the AUTO CALIBRATION screen refer to Figure 6 5 The AUTO CALIBRATION screen changes during the calibration process as reference values are entered and as runs are completed These changes are discussed in Auto Cal Method later in this section When the AUTO CALIBRATE key is pressed the following soft key labels are displayed WHOLE BLOOD CALIBRATOR This key alternates...

Page 316: ...Calibration Screen The WHOLE BLOOD and CALIBRATOR keys alternate to display which type of calibration material is being used This information is displayed in the upper left corner of the screen and stored with the updated calibration factors on the Calibration Log Print The PRINT key is used to print the data displayed on the screen ...

Page 317: ...les should be used when calibrating both modes Either mode may be calibrated first but it is recommended to calibrate the primary mode first NOTE Calibrator is the preferred material for calibrating the CELL DYN 3200 System When samples are run Auto Cal does the following 1 Accepts up to ten consecutive sample runs for either calibrator or fresh whole blood samples 2 Compares sample results agains...

Page 318: ...afety procedures 1 Go to a reference hematology instrument or use appropriate hematology methods with one sample of normal fresh whole blood NOTE The Auto Cal method is designed for 1 sample If you want to use more than one fresh whole blood you must use the Enter Factor method 2 Run a minimum of 10 replicates from this sample on the reference instrument NOTE Because the same sample will be used t...

Page 319: ...ation sample is run the calibration program adds a and the run number from 01 to 10 Figure 6 6 Auto Calibration Screen Start Auto Cal Figure 6 6 shows the AUTO CALIBRATION screen before any reference values are entered When the first reference value has been entered and the Enter key pressed the START AUTO CAL and QUIT keys are displayed refer to Figure 6 7 After the START AUTO CAL key is pressed ...

Page 320: ...yed A message is displayed on the bulletin line alerting the operator to start running samples As samples are processed the results of each run are displayed as shown in Figure 6 8 The following soft keys are displayed ACCEPT Label appears after the 5th run DELETE A RUN Label appears after the 1st run QUIT Label appears after the 1st run PRINT RETURN ...

Page 321: ...ch run The Mean Factor is an average based on all runs The Factor Diff shows the difference between the Mean Factor and the existing Calibration Factor for that parameter The CV Coefficient of Variation expressed as a percent measures the degree of variation between runs NOTE The Mean Factor is the new Calibration Factor If a result is highlighted in Green on the Run line it indicates that paramet...

Page 322: ...be deleted and press the Enter key NOTE Only one run can be deleted in each calibration session The system does not allow a deleted run to be replaced with a new run For example if there are 10 runs and the operator deletes Run 5 then calibration will be based on 9 runs remember a highlighted result on a run will not be included in the Mean Factor or Factor Diff for that parameter Quit When QUIT i...

Page 323: ...CELL DYN 3200 System Operator s Manual 6 25 9140181H October 2001 Section 6 Calibration Procedures Figure 6 9 ACCEPT Key Displayed Figure 6 10 Confirm Acceptance of New Factors ...

Page 324: ...dure in subsection Fresh Whole Blood under Determining Reference Values above NOTE Enter the WBC mean as the reference value for both WOC and NOC 2 Press the Enter key after each entry to save the value and advance the cursor to the next parameter NOTE To change a value after it was entered place the cursor on the appropriate field and enter the correct value To clear a value press QUIT followed b...

Page 325: ... on the screen will replace the existing calibration factor when the ACCEPT key is pressed Green indicates the Factor Diff is within the range specified in column 3 of Worksheet 3 Open Mode Calibration Range Criteria provided in Manual Calibration Worksheets at the end of this section c If the value is highlighted in purple it indicates the Factor Diff is greater than the value shown in column 4 o...

Page 326: ... for the operator to overwrite these values However the change only appears on the screen the actual values calculated by the calibration program remain intact and the Mean Factors are not affected c If no component was changed and your calculations are correct DO NOT CALIBRATE CONFIRM THAT ALL PRE CALIBRATION PROCEDURES WERE COMPLETED AND THEN CALL THE ABBOTT HEMOTOLOGY CUSTOMER SUPPORT CENTER FO...

Page 327: ...nd 5 again If the mean is still outside the tolerance limits call the Abbott Hematology Customer Support Center for assistance at 1 800 CELL DYN in the U S 8 When Open Mode calibration has been confirmed do one of the following a If Closed Mode has not yet been calibrated go to subsection Auto Cal Procedure Closed Mode b If Closed Mode calibration has been completed press MAIN to return to the MAI...

Page 328: ...h Whole Blood invert the sample ten times Do not shake the specimen Place the well mixed specimen in the Tube Retainer close the door and press the Touch Plate The instrument performs RUN 1 and displays the values in the RUN 1 row 2 Repeat step 1 above until the desired number of runs for either Calibrator or Fresh Whole Blood has been completed Calibration Check During the RUN cycle if a paramete...

Page 329: ... required and no calibration confirmation is required 2 If Open Mode has not been calibrated go to subsection Auto Cal Open Mode otherwise return to the MAIN MENU by pressing RETURN followed by MAIN Some Parameters Need Calibration 1 If at least one Factor Diff value is highlighted in green and if no Factor Diff values are highlighted in purple press ACCEPT followed by CONFIRM ACCEPT to calibrate ...

Page 330: ...to calibrate the instrument 1 In the CALIBRATION menu press MAIN to return to the MAIN MENU 2 In the MAIN MENU press RUN followed by SPECIMEN TYPE Select an empty QC file and press QC SPECIMEN 3 Refer to Worksheet 7 Calibration Confirmation in Manual Calibration Worksheets at the end of this section Make copies of this worksheet as necessary 4 Run the same Calibrator or Fresh Whole Blood samples i...

Page 331: ...ll be used to first obtain reference values on a reference instrument then to calibrate in the Open and Closed Modes it is important to begin with a sufficient amount of sample 12 mL each is recommended A set of worksheets is provided in Manual Calibration Worksheets at the end of this section to assist in the calibration process NOTE Always complete the Pre Calibration procedures before beginning...

Page 332: ...o the requirements listed in Fresh Whole Blood Requirements under Calibration Materials earlier in this section the following procedures apply when using the Enter Factor method 1 A minimum of five samples are required for adequate calibration 2 Mean values should be calculated for each parameter based on 10 runs five samples each run twice into one QC file These mean parameter values can then be ...

Page 333: ...tocrit values may be determined by multiple analyses using the NCCLS method for Packed Cell Volume PCV 2 Use only plain non anticoagulated capillary tubes Be certain to verify the proper operation of the microhematocrit centrifuge and the timer as recommended by NCCLS Determining Reference Values Fresh Whole Blood Follow the procedures below to determine the reference values that will be used to c...

Page 334: ...for each parameter For example The cumulative Reference WOC Mean is 7 15 when the WOC results from each run are as follows Sample 1 9 2 9 1 Sample 2 4 5 4 6 Sample 3 6 1 5 9 Sample 4 7 0 7 3 Sample 5 8 9 8 9 The cumulative mean of 7 15 equals the sum of the values 71 5 divided by the 10 runs You may use the worksheet on the following page to record the values obtained from running samples on a ref...

Page 335: ...L DYN 3200 Instrument Calibration Procedure Open Mode Follow the procedure below for calibrating the instrument in the Open Mode NOTE Use the same Calibrator or Fresh Whole Blood samples for calibrating Open and Closed Modes Determining New Calibration Factors 1 If necessary go to the RUN menu and press CHANGE SAMPLER to select the Open Mode 2 In the MAIN MENU press CALIBRATION to display the main...

Page 336: ...ng the tube at least ten times Do not shake the specimen WARNING Potential Biohazard Consider all specimens calibrators and controls that contain human blood as potentially infectious Wear gloves lab coats and safety glasses and follow other biosafety procedures as specified in the OSHA Bloodborne Pathogen Rule 29 CFR 1910 1030 or other equivalent biosafety procedures 6a If calibrator material is ...

Page 337: ...ructions on Worksheet 1 to calculate the new Open Mode Calibration Factor for each parameter and enter this information in column 4 of the worksheet The method for determining the new factors is a Calibrator Calibration b Whole Blood Calibration For example if the Reference Mean Value for WOC is 6 6 the CELL DYN Mean for WOC is 7 1 and the current Open Mode Calibration Factor for WOC is 0 98 then ...

Page 338: ...ets 1 and 2 b Determine if any component on the instrument was changed This could affect calibration Such components include the Shear Valve Optical Flow Cell Hemoglobin Flow Cell or one of the syringes c If a component was changed then treat the result as if it fell within the calibration range even though it is greater than the upper limit CALIBRATION IS REQUIRED for that parameter d If no compo...

Page 339: ...s the RESTORE FACTORS soft key to recall factors stored on the Hard Disk corresponding to the current mode Open or Closed RESET ALL TO 1 000 is used to reset all factors displayed on the screen to 1 000 3 When all new factors have been entered press RETURN to display the CALIBRATION LOG screen with the new calibration factors NOTE If no changes are made in the ENTER CALIBRATION FACTOR screen press...

Page 340: ...tion process and run each sample once When the five runs are complete print the appropriate QC file and transfer the mean values to the appropriate spaces on Worksheet 7 4 Follow the instructions on the worksheet for comparing the mean value against the assay values calibrator or reference mean fresh whole blood 5 If the difference between the mean of 3 5 runs and the assay value reference mean is...

Page 341: ... the SPECIMEN TYPE menu d Use the arrow keys on the keyboard to move the cursor to an empty QC file and type the desired name in the File Name field e Press Enter to save the name Use the Up Arrow key to move the cursor back to the file name f Press QC SPECIMEN to return to the RUN screen WARNING Potential Biohazard Consider all specimens calibrators and controls that contain human blood as potent...

Page 342: ...ave been aliquoted for a total of 10 tubes d Place the closed tubes on a rack and set the rack on the load side e Press START LOADER Allow the instrument to process all the samples 7 When sample processing is completed press MAIN followed by QUALITY CONTROL Use the arrow keys to place the cursor on the appropriate QC file and press VIEW QC LOG 8 Press PRINT QC LOG to print the Summary Report for t...

Page 343: ...recommended that the primary mode Open Mode be calibrated first b If none of the parameters requires Closed Mode calibration and Open Mode calibration has already been completed press MAIN to return to the MAIN MENU 4 For each parameter if the Diff falls between the upper and lower calibration range shown in the Calibration Range column then CALIBRATION IS REQUIRED 5 For each parameter if the Diff...

Page 344: ...WOC is 7 4 and the current Closed Mode Calibration Factor for WOC is 1 04 then 6 6 7 4 1 04 0 93 and 0 93 is the New Closed Mode Calibration Factor for WOC 2a If the new Closed Mode Calibration Factors falls within the acceptable range given on the worksheet follow the procedure for entering new calibration factors below 2b If the New Closed Mode Calibration Factor for a given parameter falls outs...

Page 345: ... the RESTORE FACTORS soft key to recall factors stored on the Hard Disk corresponding to the current mode Open or Closed RESET ALL TO 1 000 is used to reset all factors displayed on the screen to 1 000 3 When all new factors have been entered press RETURN to display the CALIBRATION LOG screen with the new calibration factors NOTE If no changes are made in the ENTER CALIBRATION FACTOR screen pressi...

Page 346: ...ration process and run each sample once When done print the appropriate QC file and transfer the values in the appropriate space on the Worksheet 7 NOTE Closed Mode Calibration may also be confirmed by running commercial controls 4 Follow the instructions on the worksheet for comparing the mean value against the assay value calibrator or reference mean fresh whole blood 5 If the difference between...

Page 347: ...list if a reagent and or lot number of reagent was changed just prior to the calibration procedure 3 Include documentation as to the resolution of the problem in the instrument logbook Calibration Backup The current calibration factors should be saved on the CELL DYN 3200 Set Up Disk 1whenever calibration is changed Data should also be saved whenever any Set Up information is changed and after any...

Page 348: ...will overwrite the current calibration and instrument setting files in the CELL DYN 3200 directory with previously saved versions from the archive on the floppy disk In this case the instrument may need to be recalibrated and instrument settings may need to be re established by a field service representative This option is used when a hardware or software failure occurs and should only be used at ...

Page 349: ...ned for the Open Mode procedure three worksheets for the Closed Mode procedure and one worksheet for confirmation Worksheet 1 Open Mode Calibration New Factors Worksheet 2 Open Mode Factor Difference Worksheet 3 Open Mode Calibration Range Criteria Worksheet 4 Mode to Mode Calibration Difference Worksheet 5 Mode to Mode Calibration Criteria Worksheet 6 New Closed Mode Calibration Factors Worksheet...

Page 350: ...edure 4 For each parameter divide the value in column 1 by the value in column 2 and multiply the result by the value in column 3 5 The value calculated in step 4 is the new calibration factor Write this value in column 4 6 Compare the new calibration factor in column 4 with the range shown in column 5 If the new factor falls within the range go to Worksheet 2 If the new factor falls outside the r...

Page 351: ...actor Diff from column 5 of the previous worksheet disregard the sign 2 If the new Factor Diff exceeds the limit in column 4 DO NOT CALIBRATE Call the Abbott Hematology Customer Support Center for assistance Worksheet 2 Open Mode Factor Difference Calculate All Factors To Three Decimal Places 1 New Open Mode Factor 2 Current Open Mode Factor 3 New Open Mode Factor 4 x 100 5 Factor Diff WOC x 100 N...

Page 352: ...er Support Center for assistance Mode to Mode Calibration Difference Calculate All Factors To Three Decimal Places 1 Closed Mode Mean 2 Open Mode Mean 3 Open Mode Mean x 100 4 Diff WOC x 100 NOC x 100 RBC x 100 HGB x 100 MCV x 100 PLT x 100 Worksheet 5 Mode to Mode Calibration Criteria 1 Diff 2 Lower Limit Cal Not Required 3 Calibration Range Cal Required 4 Upper Limit Do Not Cal 5 Cal Y N WOC 2 0...

Page 353: ...rate Check all calculations and call the Abbott Hematology Customer Support Center for assistance at 1 800 CELL DYN in the U S New Closed Mode Calibration Factors Calculate All Factors To Three Decimal Places Open Mode Mean Closed Mode Mean x Current Closed Mode Cal Factor New Closed Mode Cal Factor Range WOC x 0 700 1 300 NOC x 0 700 1 300 RBC x 0 800 1 200 HGB x 0 700 1 300 MCV x 0 700 1 300 PLT...

Page 354: ...e difference between the mean and the reference or assay value 5 Compare the difference with the Tolerance Limit If it is within the limit calibration is confirmed QC specimen type allows confirmation of both WOC and NOC values For Calibrator use the pre established tolerance limits found on the Calibrator Assay Sheet For Fresh Whole Blood each laboratory should establish tolerance limits accordin...

Page 355: ... 6 Calibration Procedures References 1 ICSH Protocol for Evaluation of Automated Blood Cell Counters Clinical and Laboratory Hematology 1988 10 203 212 2 NCCLS standard H7 A Procedure for Determining Packed Cell Volume by the Microhematocrit Method Approved Standard 1985 ...

Page 356: ...6 58 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Calibration Procedures References Section 6 NOTES ...

Page 357: ... in Section 9 Service and Maintenance During the warranty period all service and repair must be performed by Abbott authorized representatives Location Requirements The location of the CELL DYN 3200 System is an important consideration that affects proper instrument functioning operating safety and ease of use An Abbott authorized representative must install the instrument The location should have...

Page 358: ...around the instrument to perform necessary maintenance procedures to provide service access and to allow the instrument to be easily disconnected from its power source Care should be taken to prevent blocking of the air vents or fans on the sides and the back of the instrument Before operating the instrument for the first time verify that each reagent line is connected to the appropriate inlet and...

Page 359: ...se the reagent Protect reagents from direct sunlight evaporation and contamination Use the Reagent Container Cap attached to each length of inlet tubing to minimize evaporation and contamination Never add remaining reagent from a container being replaced to a freshly opened container This may contaminate the new reagent Never use a hemoglobin standard other than the one specified for the CELL DYN ...

Page 360: ...7 4 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Operational Precautions and Limitations Precautions Section 7 NOTES ...

Page 361: ...appear next to signal words that identify hazards Warning Conventions Signal Words DANGER Denotes an immediate hazard which if not avoided could result in serious injury or death WARNING Denotes a hazard which if not avoided could result in moderate to serious injury CAUTION Denotes a potential hazard that could result in injury Also used for conditions or activities which could interfere with pro...

Page 362: ...8 2 CELL DYN 3200 System Operator s Manual 9140181K July 2002 Hazards Overview Section 8 NOTES ...

Page 363: ...y contaminated with infectious material Avoid contact with the tips of the probe and needle Spills of potentially infectious materials should be cleaned up in accordance with established biosafety practices A generally accepted procedure for cleaning such spills is to absorb the spill with toweling or other absorbent material wipe the area with an appropriate tuberculocidal disinfectant such as 0 ...

Page 364: ...pment before performing maintenance on parts which require protective covers to be removed for access Use only approved power cords and electrical accessories supplied with the instru ment or provided by Abbott to protect against electrical shock CAUTION Electrical Hazard Turn off the power to the instrument and disconnect the power cord before removing any instrument panel that is securely fasten...

Page 365: ... any mechanical component when the instrument is operating Do not wear articles of clothing or accessories that could catch on the System keep pockets free of items that could fall into the System keep long hair from catching on the System Wear powder free gloves and safety glasses when maintaining or repairing the instrument Avoid contact with needle tips at all times Use professional assistance ...

Page 366: ... to cause eye damage CAUTION Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous laser light exposure During normal operation the inner protective cover is to remain in place to prevent laser light exposure from the optics bench The inner protective cover is to be removed only during servicing by qualified personnel The inner protec...

Page 367: ...ing Label Position Protective Cover Figure 8 3 Laser Warning Label Position Flow Panel 1 Protective Cover 2 Laser Warning Label 1 Laser Warning Label 2 1 CAUTION CLASS 3B LASER LIGHT WHEN OPEN AVOID EXPOSURE TO BEAM PN 9230701E 1 CAUTION CLASS 3B LASER LIGHT WHEN OPEN AVOID EXPOSURE TO BEAM PN 9230701 ...

Page 368: ...ack lettering against a yellow background Figure 8 4 Class 1 Laser Product Label The label is located on the upper left section of the instrument s Rear Panel and is positioned in a clearly visible location refer to Figure 8 5 Figure 8 5 Class 1 Laser Product Label Location CLASS 1 LASER PRODUCT PN 9230702 1 Main Power Switch 2 Class 1 Laser Product Warning Label 1 2 CLASS 1 LASER PRODUCT PN 92307...

Page 369: ...ion 29 CFR Part 1910 1030 Department of Labor Occupational Exposure to Bloodborne Pathogens Final Rule 235 64175 64182 1991 2 IEC 60825 1 International Electrotechnical Commission World Standards for electrical and electronic engineering 60825 Safety of laser products 60825 1 Part 1 Equipment classification requirements and users guide ...

Page 370: ...8 10 CELL DYN 3200 System Operator s Manual 9140181K July 2002 Hazards References Section 8 NOTES ...

Page 371: ... completed The operator is encouraged to routinely perform the required maintenance in order to ensure optimum performance This section describes the recommended preventive maintenance procedures for the Analyzer Instructions are also given for preparing the instrument for a prolonged period of inactivity Many required preventative maintenance procedures have been automated on the CELL DYN 3200 Th...

Page 372: ...9 2 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Service and Maintenance Overview Section 9 NOTES ...

Page 373: ...reen level is accessed by pressing the MORE key in the first level Within each major level are submenus Figure 9 1 displays the key labels in the first SPECIAL PROTOCOLS menu NOTE Prior the entering the SPECIAL PROTOCOL menu to perform a procedure ensure the instrument is at the READY state Figure 9 1 First Special Protocols Screen Special Protocols Menu When the SPECIAL PROTOCOLS key is pressed i...

Page 374: ...e maintenance procedure Figure 9 2 Reagent Reservoir Keys Reagent Reservoir NOTE This procedure is performed only in the Open Mode If necessary press CHANGE SAMPLER in the RUN screen to select Open Mode The REAGENT RESERVOIR key is used to drain the reagent reservoirs located on the Flow Panel of the Analyzer When the REAGENT RESERVOIR key is pressed the following soft key labels are displayed as ...

Page 375: ... CELL key displays a submenu showing the EMPTY FLOW CELL and RETURN keys When the EMPTY FLOW CELL key is pressed diluent sheath in the Optical Flow Cell is drained and the key toggles to FILL FLOW CELL upon completion When the FILL FLOW CELL key is pressed the flow cell is refilled with diluent sheath Clean Restore Shear Valve NOTE This procedure is performed only in the Open Mode If necessary pre...

Page 376: ...ZER When the ENABLE ANALYZER key is pressed the Analyzer is returned to the state prior to disabling Figure 9 3 Second Special Protocols Screen More When the MORE key is pressed the second SPECIAL PROTOCOLS screen and the following soft key labels are displayed as shown in Figure 9 3 AUTO CLEAN DAILY SHUTDOWN PREPARE SHIPPING CLEAN NEEDLE EXTENDED AUTOCLEAN MORE MAIN Auto Clean NOTE This procedure...

Page 377: ...procedure is performed only in the Open Mode If necessary press CHANGE SAMPLER in the RUN screen to select Open Mode The PREPARE SHIPPING key is used to prepare the Analyzer for shipment or an extended period of inactivity The cycle drains all of the reagents from the system and then rinses the fluidics with deionized water supplied by the operator Clean Needle The CLEAN NEEDLE key is used to clea...

Page 378: ...9 8 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Service and Maintenance Special Protocols Section 9 NOTES ...

Page 379: ...ring the maintenance procedures They should be powder free or rinsed before performing the maintenance as powder may cause instrument problems For example powder may clog ports in the shear valve and cause it to leak IMPORTANT Overdue maintenance is usually indicated by an increase in imprecision of one or more of the directly measured parameters This increase is due to carryover or dilution sampl...

Page 380: ...lean Cycle Clean Closed Sample Aspiration Needle Clean Closed Sample Tower Weekly Clean Sample Loader and Racks Check Sample Transfer Pump Tubing Run the Extended Auto Clean Cycle if routinely running reticulocyte counts Monthly Clean Fan Filter Run Extended Auto Clean Replace Diluent Sheath Filter Semi Annual Clean Printer Nonscheduled Maintenance Procedures Clean Shear Valve Clean Interior of Op...

Page 381: ...nce procedures Figure 9 4 Analyzer Flow Panel Components 1 Vent 2 Sample Transfer Peristaltic Pump 3 Waste Chambers 4 WBC Mixing Chamber 5 RBC Mixing Chamber 6 HGB Flow Cell 7 Shear Valve 8 Y Valve 9 Open Sample Probe With Wash Block 10 Normally Closed Valves 11 Diluent Reservoir 12 Sheath Reservoir 13 Normally Closed Valves 14 Diluent Sheath Filter 15 Tube Spinner 16 Closed Sample Needle With Was...

Page 382: ...lution To calculate the percent sodium hypochlorite concentration desired see the following formula A Percent of sodium hypochlorite solution desired B Percent of sodium hypochlorite stock solution as purchased X Parts of water to be mixed with one part of the sodium hypochlorite stock solution Example If you need a 0 5 solution of sodium hypochlorite for a cleaning procedure and the label on the ...

Page 383: ... RBC PLT Mixing Chamber the WBC Mixing Chamber the Optical Flow Cell the HGB Flow Cell Open Sample Probe the needle in the Tower Module and all the associated fluidics The forward and reverse action of the peristaltic pump is used during this cycle to gently scrub and remove any fibrin or debris within the system The Auto Clean cycle takes approximately 12 minutes When the AUTO CLEAN key is presse...

Page 384: ... one part distilled water to one part enzymatic cleaner 3 In the MAIN MENU press SPECIAL PROTOCOLS Iollowed by MORE to access the Auto Clean function 4 Press AUTO CLEAN Instructions for performing the procedure are displayed on the screen 5 Dispense approximately 1 5 mL of Enzymatic Cleaner into the VACUTAINER or other clean container and hold the container under the probe 6 Press AUTO CLEAN to ac...

Page 385: ...ress the CHANGE SAMPLER soft key in the RUN screen to select the Closed Mode 4 In the RUN screen press SPECIMEN TYPE followed by BACKGROUND 5 Place the enzymatic cleaner tube followed by the two diluent tubes in a Sample Loader rack NOTE A convenient way to perform this procedure is to add the tubes to the end of the last run of the day 6 Position the rack on the load side of the Sample Loader ref...

Page 386: ...nt samples If the counts are unacceptable troubleshoot accordingly refer to Section 10 Troubleshooting and Diagnostics Subsection Troubleshooting Guide Closed Sample Tower Daily cleaning of the Tower Module is recommended when the Closed Mode is used Materials Required 1 Cleaning solution 0 5 sodium hypochlorite solution See the formula for mixing this solution under Decontamination Procedures ear...

Page 387: ...ower Cover up and off the instrument 2 Remove any racks from the loader 3 Clean the following components with a lint free wipe moistened with the cleaning solution prepared above a Sample Loader tray be sure to remove any dirt or debris that may impede the movement of the racks b Tube grippers inside the Mixing Block on the SL model rotate the Mixing Block to gain access to the grippers c Any othe...

Page 388: ...9 18 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Service and Maintenance Daily Maintenance Procedures Section 9 NOTES ...

Page 389: ...re 1 Remove the racks from the Sample Loader 2 Wash the racks in the detergent solution Do not allow them to soak in the solution because the labels will come off NOTE Do not wash the racks in an automated dishwasher that operates at high temperatures because the heat may damage the racks 3 Rinse the racks with warm water and dry thoroughly with a DYN A WIPE or other lint free pad 4 Wipe the Sampl...

Page 390: ...gure 9 6 5 Visually inspect the tubing for damage If the tubing is damaged or flattened change the tubing Refer to Peristaltic Pump Tubing Replacement later in this section 6 Using your fingers massage the tubing to test its strength and resiliency and to remove any indentation caused by the wheel 7 Push the Pump Shoe away from the pump wheel and slip the tubing back under the wheel Make sure the ...

Page 391: ...orne Pathogen Rule 29 CFR Part 1910 1030 or other equivalent biosafety procedures Fan Filter Cleaning There is an air filter on the rear panel of the Analyzer The filter requires monthly removal and cleaning to maintain a constant unrestricted air flow NOTE More frequent cleaning is required whenever the instrument is located in a particularly dusty or warm area Figure 9 7 shows the location of th...

Page 392: ...he Fan Filter on the rear panel Refer to Figure 9 7 4 Snap off the plastic frame which holds the filter in the mounting bracket 5 Remove the filter and run a medium pressure stream of warm water over them or clean the filter by vacuuming them 6 Blot dry the filter with a lint free pad 7 Reinsert the cleaned filter into its frame and snap the frame back onto the mounting bracket 8 Turn the power sw...

Page 393: ...forward and reverse action of the peristaltic pump is used during this cycle to gently scrub and remove any fibrin or debris within the system The Extended Auto Clean cycle takes approximately 2 5 hours to complete During this time the instrument is not available to process samples or manipulate data When the process is complete the instrument is automatically put in the STANDBY state NOTE Once th...

Page 394: ...ner and hold the container under the probe Raise the container until the end of the probe is completely immersed in the solution 6 3UHVV EXTENDED AUTOCLEAN DJDLQ WR DFWLYDWH WKH FOHDQLQJ F FOH NOTE Do not press the Touch Plate The Extended Auto Clean cycle is initiated only by the EXTENDED AUTOCLEAN key 7 Continue to hold the container under the probe until a beep tone is heard Remove the containe...

Page 395: ...neous 5 part differential results Refer to the Troubleshooting Guide for more details Materials Required 1 Diluent Sheath Filter List Number 06H92 01 2 Paper Towel 3 Hemostat 4 Gloves Safety Glasses Lab Coat Procedure 1 If the instrument is not in the STANDBY mode then press SPECIAL PROTOCOLS followed by DAILY SHUTDOWN If the instrument is already in STANDBY mode then proceed to Step 2 2 Turn the ...

Page 396: ...let to the top of a new Diluent Sheath Filter 9 Disconnect the used Diluent Sheath Filter from the silicon tubing at the lower end and discard it 10 Attach the silicon tubing to the lower part of the new Diluent Sheath Filter 11 Remove the hemostats 12 Install the new Diluent Sheath Filter into the spring clip 13 Turn the Power Switch ON 14 Wait until the instrument is initialized then press RUN t...

Page 397: ...f operation turn the printer OFF disconnect the power cord and use a clean dry cloth to dust the area around the carriage shaft and platen or ink cartridge depending on type of printer Be sure to remove any loose particles of paper Do not use solvents or strong detergents on the cabinet Refer to the printer manual that accompanied your printer for detailed cleaning and maintenance instructions ...

Page 398: ...9 28 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Service and Maintenance Semiannual Maintenance Procedures Section 9 NOTES ...

Page 399: ...e of imprecision Unclog Closed Sample Aspiration Needle When a blockage is suspected Clean Sample Injection Syringe WBC and HGB Lyse Syringes When they are suspected of being the source of imprecision Clean Diluent Sheath Syringe When it is suspected of being the source of imprecision Clean HGB Flow Cell When Auto Clean has not cleared away a restriction or an organic buildup is suspected of causi...

Page 400: ...it shows signs of indentation or flattening Replace Syringes 1 When it develops a leak 2 When it is suspected of being a source of imprecision Replace Fuse 1 When the fuse fails 2 When changing the power setting from 110 120 VAC to 220 240 VAC or vice versa Prepare for Shipping or Extended Period of Non Use 1 When shipping the instrument 2 When storing the instrument 3 Before an extended period of...

Page 401: ...embly is depicted in Figure 9 10 The shear valve is made of a ceramic material and consists of three separate sections front center and rear The rear and front sections are connected to the CELL DYN 3200 by tubing that should not be removed NOTE The center section is not connected by tubing and must be handled carefully as it will break if it is dropped Care should be taken to avoid chipping scrat...

Page 402: ...ck sections and it may break or crack if dropped 7 Place the center section in a container of warm water and allow it to soak for the remainder of the cleaning procedure NOTE Do not soak the center section in bleach because the bleach may damage the ceramic 8 Clean the mounting arm with a DYN A WIPE or other lint free pad dampened with warm water to remove any blood or residue Wipe the guide dry 9...

Page 403: ...als such as gauze pads that may have been left on the instrument 19 Press RESTORE SHEAR VAL WR UHWXUQ WKH 6KHDU 9DOYH WR LWV RSHUDWLQJ SRVLWLRQ DQG WR UHWXUQ WKH LQVWUXPHQW to the READY state 20 Replace the Tower Cover Tower Door on the CS model must be open 21 Press RETURN followed by MAIN DQG RUN to display the RUN screen 22 Run at least five background counts to rinse the system Check that the ...

Page 404: ...beaker or container under the probe to catch the rinse solution Hint Attach one end of a length of 1 32 tubing to the aspiration end of the probe and place the other end of the tubing in the beaker to prevent splashing Figure 9 11 Open Sample Probe Assembly 3 Hold the probe firmly with one hand and with the other hand use the pliers to carefully work the tubing up and off the top of the probe 4 Us...

Page 405: ... any tubing that may have been placed on the aspiration end of the probe NOTE Wetting the top portion of the probe will allow the tubing to slide more easily 7 Be sure to remove the beaker containing the rinse solution from the instrument 8 Press ENABLE ANALYZER followed by RETURN and MAIN to return to the MAIN MENU 9 Press RUN followed by SPECIMEN TYPE and BACKGROUND 10 Run at least three backgro...

Page 406: ...on Procedure WARNING Potential Biohazard The sample needle is sharp and potentially contaminated with infectious material Avoid contact with the tip of the needle 1 In the MAIN MENU press SPECIAL PROTOCOLS IROORZHG E DIS ENAB ANALYZER DQG DISABLE ANALYZER 2 Pull the tower cover up and off the instrument Tower Door on the CS model must be open 3 Locate the Aspiration Tubing and Vent Tubing attached...

Page 407: ... prepared earlier Attach the tubing connected to the syringe onto the top of the Aspiration Needle and inject the solution to flush the needle 8 Fill the same syringe with deionized water and inject the water into the needle from the top to rinse it Repeat the procedure three times to thoroughly rinse the needle NOTE Empty the container between rinses as necessary 9 Repeat steps 7 and 8 to flush V...

Page 408: ...tion NOTE It is important that the tubing be attached correctly Refer to Figure 9 12 NOTE Wetting the top portion of the needle will allow the tubing to slide more easily 13 Reattach the Tower Cover Tower Door on the CS model must be open and press into place 14 Press ENABLE ANALYZER followed by RETURN and MAIN to return to the MAIN MENU 15 Run at least three background counts to rinse the system ...

Page 409: ...mblies each containing two syringes on the Flow Panel of the CELL DYN 3200 system The syringe assemblies are depicted in Figure 9 13 Syringes on the CELL DYN 3200 System should be cleaned only as necessary one at a time to ensure that each syringe is replaced in the correct position Replace each syringe after it is cleaned and then remove the next one to be cleaned Figure 9 13 Syringe Assemblies 1...

Page 410: ...hold feature on upper door hinge mechanism can be engaged Lower door gently Gently pull the Tower Cover and lift the cover up and off the instrument Tower Door on the CS model must be open a On the CS model remove the four Phillips head screws holding the Front Skirt to the instrument and remove the skirt b The skirt on the SL model has two removable sections adjacent to the Flow Panel Remove the ...

Page 411: ...15 Sample Loader Mounting Screws 3 Carefully lift and pull the Sample Loader away from the instrument approximately 2 3 inches 4 Push the Sample Loader down to lock it in to place Figure 9 16 Sample Injection Syringe Removal 1 Tube Fitting 2 Sample Injection Syringe 3 Double Collar 4 Base 5 Luer Lock 5 1 2 3 4 ...

Page 412: ...ay damage the plunger Avoid touching the plunger because oil from the fingers may cause it to move erratically 5 Rinse the plunger and barrel thoroughly with distilled water Carefully reinsert the plunger into the wet barrel 6 Refill the syringe with fresh Diluent Sheath reagent to the same level as noted in step 3 NOTE Verify there is no air bubble sitting on the tip of the plunger 7 Insert the t...

Page 413: ...hand grasp the syringe plunger below the metal band Pull and twist one side of the syringe to remove it from the snap in holding block 4 Note the liquid level in the syringe so that it can be refilled after cleaning to approximately the same level 5 Dispense the reagent into a sink or other appropriate waste container NOTE Do not pull the plunger out of the barrel Also do not push or pull on the p...

Page 414: ...th the slot on the holding block 10 Insert one of the vertical edges on the barrel into a side groove on the holding block and carefully twist the barrel until the other side snaps into place Make sure the syringe is firmly in place 11 Place the tube fitting into the Luer Lock and turn the lock counterclockwise until the fitting is finger tight Be careful not to overtighten the fitting or crimp th...

Page 415: ...ock it in place 3 Reinstall the Phillips head screw that holds the Sample loader Tower in place on the Front Panel Do not pinch any tubing between the Tower and the Flow Panel Refer to Figure 9 14 4 Tighten the flat head screws two on each side of the instrument Refer to Figure 9 15 c Reattach the Tower Cover Tower Door on the CS model must be open and press into place d Close the Left and Right F...

Page 416: ...b coat and safety glasses 4 Deionized water Procedure 1 In the MAIN MENU press SPECIAL PROTOCOLS followed b DIS ENABLE ANALYZER and DISABLE ANALYZER to disable the Analyzer 2 Gently pull on the hand hold of the right Front Cover to swing the cover open Pull the Tower Cover up and off the instrument Tower Door on the CS model must be open Locate the HGB Flow Cell Refer to Figure 9 4 3 Remove the pl...

Page 417: ...ground counts are acceptable before running controls or patient samples If the counts are unacceptable troubleshoot accordingly refer to Section 10 Troubleshooting and Diagnostics Subsection Troubleshooting Guide 14 Record this maintenance in your maintenance log Bar Code Reader Window Cleaning The cleaning procedure is similar for the SL and CS models even though the location of the Bar Code Read...

Page 418: ...SABLE ANALYZER 2 Gently pull on the hand hold of the Right Front Cover and swing the cover open to access the right side of the Flow Panel Remove Tower Cover 3 Locate the tubing attached to the top of the Open Sample Probe Refer to Figure 9 19 Hold the probe firmly with one hand and with the other hand use the pliers to carefully work the tubing up and off the top of the probe 4 Using the Allen wr...

Page 419: ...RETURN MAIN and RUN 10 Press the Touch Plate to run a background count Observe the action of the probe assembly to ensure there are no leaks and that it is operating smoothly 11 Close the Right Front Cover Reattach the Tower Cover and press into place Tower Door on the CS model must be open 12 Run at least three background counts to rinse the system Check that the background counts are acceptable ...

Page 420: ...th infectious material Avoid contact with tip of needle 1 In the MAIN MENU press SPECIAL PROTOCOLS IROORZHG E DIS ENAB ANALYZER and DISABLE ANALYZER 2 Pull the Tower cover up and off the instrument Tower Door on the CS model must be open 3 Locate the Aspiration Needle NOTE The Aspiration Needle consists of two separate needles joined together one for venting and one for aspiration Refer to Figure ...

Page 421: ...e up and out of the Wash Block 7 Place the new needle into the Wash Block making sure the shorter part venting needle faces the instrument and place the flange into its slot in the top bracket 8 Reinstall the clip over the top of the needle and tighten the Thumb Screw 9 Attach the vent tubing to the vent section of the needle and the aspiration tubing to the aspiration section NOTE It is important...

Page 422: ...Gloves lab coat and safety glasses Procedure 1 In the MAIN MENU press SPECIAL PROTOCOLS followed by DIS ENAB ANALYZER and DISABLE ANALYZER 2 Gently pull on the hand hold of the Left Front Cover and swing the cover open 3 Locate the Sample Transfer Peristaltic Pump on the left side of the panel Refer to Figure 9 4 4 Push the Pump Shoe away from the pump wheel and slip the tubing out 5 Remove the tu...

Page 423: ...up and off the instrument Tower Door on the CS model must be open 5 To gain access to the lower portion of the Flow Panel a On the CS model remove the four Phillips head screws holding the Front Skirt to the instrument and remove the skirt b On the SL model remove the section on the left side of the Flow Panel by lifting it up and off the holding pins on the rear rail of the Sample Loader 6 Locate...

Page 424: ... using the four Phillips head screws Do not pinch the tubing at the bottom b On the SL model align the removable left side skirt panel over its holding pins and slide down c Close the Left and Right Front Covers Reattach the Tower Cover and press into place Tower Door on the CS model must be open 12 Turn the Power switch ON Wait until the instrument is initialized then press RUN to prime the syste...

Page 425: ...om 110 120 VAC to 220 240 VAC or vice versa Materials Required 1 Replacement fuse 8 amp T Slo Blo for instruments operating at 110 120 VAC or 4 amp T Slo Blo for instruments operating at 220 240 VAC 2 Flathead screwdriver Procedure CAUTION Electrical Hazard Turn off the power to the instrument and disconnect the power cord before removing any instrument panel that is securely fastened in place by ...

Page 426: ... new fuse either end into the holder Insert the holder fuse first all the way into the fuse slot 8 Insert a flathead screwdriver into the notch on the fuse holder push in and turn clockwise to tighten the fuse holder 9 Reconnect the power cord and turn the system ON 10 Record the maintenance in your maintenance log Preparation for Shipping or Extended Period of Non Use The Prepare For Shipping cyc...

Page 427: ...r valve dummy center section Procedure 1 In the MAIN MENU press SPECIAL PROTOCOLS followed by MORE and PREPARE SHIPPING 2 Follow the instructions displayed on the screen 3 Press the PREPARE SHIPPING key again to begin the rinse cycle NOTE The message SPECIAL PROTOCOL CYCLE IN PROGRESS is displayed during the process 4 When the process has finished the message SPECIAL PROTOCOL CYCLE HAS COMPLETED i...

Page 428: ...emove and clean the Shear Valve as directed in Shear Valve Cleaning under Nonscheduled Maintenance Procedures 14 After the Shear Valve has been cleaned and dried wrap the ceramic center section carefully for protection and place it in the Accessory Kit 15 Obtain the Shear Valve Dummy Center section from the Accessory Kit Reassemble the Shear Valve on the instrument using the dummy center section 1...

Page 429: ...r 4 Deionized water 5 Cleaning solution 1 25 sodium hypochlorite solution See the formula for mixing this solution under Decontamination Procedures earlier in this section Procedure Open Mode 1 If the system is not already in Open Mode press the CHANGE SAMPLER soft key in the RUN menu to select Open Mode 2 In the MAIN MENU press SPECIAL PROTOCOLS followed by DIS ENAB ANALYZER and DISABLE ANALYZER ...

Page 430: ... the syringe containing the deionized water NOTE Use paper towels to absorb any liquid that is discharged by the tubing 13 Slowly inject deionized water into the Y Valve to remove any bleach residue 14 When finished remove the syringe containing deionized water 15 Reconnect the tubing from the Y Valve to the top of the Open Sample Probe 16 Reconnect the tubing between the Y Valve and the Shear Val...

Page 431: ...ll the other syringe with deionized water 5 Attach the syringe with the cleaning solution to the tubing that had been connected to the Closed Sample Probe 6 Locate the tubing between the Y Valve and Shear Valve Refer to Figure 9 23 7 Disconnect this tubing at the Shear Valve and place the end in the beaker to catch liquid 8 Slowly inject cleaning solution into the Y Valve The liquid should pass th...

Page 432: ...round counts Check that the background counts are acceptable before running controls or patient samples 20 If the counts are unacceptable troubleshoot accordingly refer to Section 10 Troubleshooting and Diagnostics Subsection Troubleshooting Guide Rerun samples and confirm that problem is resolved 21 Record the completion of this procedure in the maintenance log ...

Page 433: ...Unclog Aspiration Probe Clean Interior of Aspiration Needle Unclog Aspiration Needle Clean Sample Loader Monthly N o n S c h e d u l e d Clean WBC Lyse Syringe Clean Sample Injection Syringe Clean HGB Lyse Syringe Clean Diluent Sheath Syringe Clean HGB Flow Cell Clean Bar Code Reader Window Clean Reagent Lines Replace Aspiration Probe Replace Tubing in Transfer Pump Replace Tubing in NC Valves Rep...

Page 434: ...9 64 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Service and Maintenance Nonscheduled Maintenance Procedures Section 9 ...

Page 435: ...ULT indicator light on the Analyzer status indicator panel is illuminated in red A description of the fault can be obtained by pressing the FAULT REPORT key in the DIAGNOSTICS MENU screen The first part of this section discusses the DIAGNOSTICS MENU keys The remainder of the section is devoted to the Troubleshooting Guide The Troubleshooting Guide is designed to assist the operator in identifying ...

Page 436: ...10 2 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Troubleshooting and Diagnostics Overview Section 10 NOTES ...

Page 437: ... that assist in troubleshooting and identify corrective action Several keys listed are described For Service Use Only The data these keys provide is meaningful only to trained field engineers and is not useful to the operator If certain keys are pressed inadvertently the system may have to be re initialized There are five primary screens in the DIAGNOSTICS MENU For ease of explanation a diagram de...

Page 438: ...REPORT EXECUTION TIMES CNT RATE SUMMARY CLEAR FAULTS RAW DATA SUMMARY MORE MAIN Fault Report When the FAULT REPORT key is pressed information regarding the pending fault is displayed on the screen The screen displays the words Operator Correctable Fault Report see Figure 10 2 or Fatal Fault Report see Figure 10 3 and any additional information available If there is no fault the screen displays the...

Page 439: ...CELL DYN 3200 System Operator s Manual 10 5 9140181H October 2001 Section 10 Troubleshooting and Diagnostics Figure 10 3 Fatal Fault Report Screen Figure 10 4 Fault Report No Fault Pending Screen ...

Page 440: ...ond DIAGNOSTICS MENU screen refer to Figure 10 9 Execution Times This key is for service use only Figure 10 5 Count Rate Summary Screen CNT Rate Summary When the CNT RATE SUMMARY key is pressed the following soft key labels see Figure 10 5 are displayed WOC CNT RATE WOC CNT GRAPH WOC CNT DATA RBC PLT CNT RATE RBC PLT CNT GRAPH RBC PLT CNT DATA NOC CNT RATE NOC CNT GRAPH NOC CNT DATA PRINT RETURN K...

Page 441: ...ee Figure 10 6 and the key label changes to CNT GRAPH for that parameter Count rate data from the last cycle is displayed in a tabular format The total count time segments and rate per second are displayed for multiple data points from that cycle See Figure 10 6 When the CNT GRAPH key for a particular parameter is pressed the rate per second data is displayed as a graph See Figure 10 7 The kinetic...

Page 442: ... 10 7 WOC Count Rate Graph Clear Faults When the CLEAR FAULTS key is pressed the Analyzer returns to the READY state if the corrective action taken resolved the problem If the corrective action did not correct the problem the fault status does not change NOTE Only operator correctable faults can be cleared with the CLEAR FAULTS key ...

Page 443: ...ssist in troubleshooting erratic or imprecise HGB results More When the MORE key is pressed the second DIAGNOSTICS MENU screen is displayed The MORE keys on the remaining screens always display the next DIAGNOSTICS MENU screen Print When the PRINT key is pressed a Diagnostic Report is printed This report contains information pertinent to the data displayed on the screen at the time the key is pres...

Page 444: ... screen Figure 10 9 Second Diagnostics Menu Screen Second Diagnostics Menu Screen When the MORE key on the first DIAGNOSTICS MENU screen is pressed the second DIAGNOSTICS MENU screen see Figure 10 9 and the following soft key labels are displayed MOTOR OPERATION SOLENOID OPERATION PUMP OPERATION DRAIN ACCUMULATOR INITIALIZATION MORE MAIN Motor Operation This key should be used only by an authorize...

Page 445: ...ter this key is pressed Figure 10 10 Pump Operation Screen Pump Operation When the PUMP OPERATION key is pressed the following soft key labels see Figure 10 10 are displayed VACUUM ON VACUUM OFF The key label alternates between the selections PRESSURE ON PRESSURE OFF The key label alternates between the selections INHIBIT PUMPS ENABLE PUMPS Displayed when VACUUM or PRESSURE keys are pressed VACUUM...

Page 446: ...ument when the screen is exited This key is useful for troubleshooting vacuum problems If the pump does not turn ON when the key is pressed the pump may be the cause of the vacuum problem Pressure On When the PRESSURE ON key is pressed the key label changes to PRESSURE OFF the pressure pump is turned ON and the screen displays the message Pressure Is On Press the PRESSURE OFF key to turn the pump ...

Page 447: ... the pumps is inhibited no vacuum and pressure are produced the screen displays the message Vacuum Is Inhibited and the key label changes to ENABLE PUMPS Press the ENABLE PUMPS key to enable pump operation NOTE The pumps are automatically enabled and control of them is returned to the instrument when the screen is exited even if the pumps were disabled while in the screen This key is useful when p...

Page 448: ...evel The key labels disappear and the incrementing time is displayed on the screen See Figure 10 13 When the test is finished the time stops incrementing and the key labels are displayed Pressure Test When the PRESSURE TEST key is pressed the system releases the pressure to atmosphere and then monitors the amount of time required for it to return to the correct level The key labels disappear and t...

Page 449: ...ccumulator Wet fault The screen displays see Figure 10 14 the following message After draining the accumulators press INITIALIZATION key to return to normal operation When the process is completed the system must be initialized and primed See Initialization below Initialization When the INITIALIZATION key is pressed the Analyzer is initialized This is necessary when a fatal fault has occurred Afte...

Page 450: ...5 Third Diagnostics Menu Screen Third Diagnostics Menu Screen When the MORE key in the second DIAGNOSTICS MENU is pressed the third DIAGNOSTICS MENU screen see Figure 10 15 and the following soft key labels are displayed SOFTWARE VERSION DIGITAL READINGS VOLTAGE READINGS GAIN ADJUSTMENT MORE PRINT MAIN These keys are for service use only ...

Page 451: ...key is pressed the voltage and vacuum pressure value from a test point measured at the moment when the key was pressed is displayed See Figure 10 16 The following additional soft key labels are displayed FINISH SELECT SELECT These two keys are for service use only The data provided by the VOLTAGE READINGS screen can be useful in determining if a problem is caused by a hardware malfunction ...

Page 452: ...Fourth Diagnostics Menu Screen When the MORE key in the third DIAGNOSTICS MENU is pressed the fourth DIAGNOSTICS MENU screen see Figure 10 17 and the following soft key labels are displayed RBC LIN DATA WBC DATA RBC DATA PLT DATA NOC DATA MORE MAIN These keys are for service use only Figure 10 17 Fourth Diagnostics Menu Screen ...

Page 453: ...l For CS models when the MORE key in the fourth DIAGNOSTICS MENU is pressed the fifth and last DIAGNOSTICS MENU screen see Figure 10 18 and the following soft key labels are displayed SERIAL TEST BAR CODE ALIGNMENT FPU TEST TOWER TEST DOOR TEST MORE MAIN These keys are for service use only Figure 10 18 Fifth Diagnostics Menu Screen CELL DYN 3200CS ...

Page 454: ...t have a LIS the loop back connector may remain connected to the COM1 port for convenience as it does not interfere with routine operation If a LIS is usually connected the loop back connector should be stored near the instrument when the connector is not in use Figure 10 19 Serial Test Screen When the SERIAL TEST key is pressed the following soft key labels see Figure 10 19 are displayed STOP TRA...

Page 455: ...ransmit Message When the TRANSMIT MESSAGE key is pressed the message CELL DYN serial interface test is transmitted from the Analyzer to the COM1 port through the loop back connector and back to the Analyzer The screen see Figure 10 20 displays the message MESSAGE SENT CELL DYN serial interface test If the test is successful the screen displays the message MESSAGE RECEIVED CELL DYN serial interface...

Page 456: ...ICS MENU is pressed the fifth and last DIAGNOSTICS MENU screen see Figure 10 21 and the following soft key labels are displayed SERIAL TEST BAR CODE ALIGNMENT FPU TEST TOWER TEST LOADER TEST MORE MAIN These keys are for service use only Figure 10 21 Fifth Diagnostics Menu Screen CELL DYN 3200SL The SERIAL TEST and MORE keys function in a similar manner to that described in section Fifth Diagnostic...

Page 457: ...step Step 2 Problem Isolation further classifies the problem Instrument problems are generally divided into three categories Hardware component related Software computer program related Measurement related to sample analysis Typically hardware and software problems are corrected by an authorized service representative Measurement problems are generally operator correctable This category is further...

Page 458: ...ease be prepared to provide the following information for the Customer Support Specialist 1 Instrument Model Name 2 Serial number of the Analyzer 3 Description of the problem 4 The lot numbers and expiration dates of the CELL DYN reagents and controls currently in use 5 Examples of sufficient data to facilitate the discussion Customer Support United States 1 800 CELL DYN or 1 800 235 5396 Abbott D...

Page 459: ...rd all results The following section is designed to guide the operator through a logical series of steps to obtain information regarding the nature of the problem If it is necessary to call for technical assistance this information should be made available to the Customer Support Specialist Troubleshooting the Background Count NOTE For the appropriate corrective action for unacceptable background ...

Page 460: ...s Subsection Using the Data Log Data Log Set Up Procedures Troubleshooting Reagent Problems If a reagent or reagents is suspected as the cause of a particular problem replace the container However the Analyzer has reservoirs that contain a small amount of reagent to maintain the supply within the system This supply must be depleted before installing the new reagent NOTE There is no reservoir for e...

Page 461: ... 2 From the first DIAGNOSTICS MENU screen press CNT RATE SUMMARY 3 Press the appropriate COUNT RATE key WOC RBC PLT or NOC to display the data for the kinetic rate Press PRINT to obtain a printout 4 Press the appropriate COUNT GRAPH key to display the graph of the kinetic data Press PRINT to obtain a printout 5 Configure the RUN screen to display the Size Complexity scatterplot and the NLM histogr...

Page 462: ...normal sample for comparison Obtain a printout of the RAW DATA SUMMARY screen immediately after the problem sample is run From the first DIAGNOSTICS MENU screen press RAW DATA SUMMARY followed by PRINT to obtain a printout Configure the Data Log to display and print WBC values If necessary refer to the instructions given in Section 5 Operating Instructions Print the results for the last 100 cycles...

Page 463: ... 9 Service and Maintenance Subsection Nonscheduled Maintenance Procedures 3 Leaking Syringe s 1 Inspect syringe for evidence of leaks 2 Verify syringe connectors are secure 3 Remove Clean Replace syringe as directed in Section 9 Service and Maintenance Subsection Nonscheduled Maintenance Procedures 4 Dirty Shear Valve 1 Clean shear valve as directed in Section 9 Service and Maintenance Subsection ...

Page 464: ...10 30 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Troubleshooting and Diagnostics Troubleshooting Procedures Section 10 NOTES ...

Page 465: ... of the instrument s status or prompt the operator to take action relative to the last operator entry 2 Fault Messages indicate fault or error detection The status conditions are listed in Table 10 1 This table defines each message and indicates its display location The fault conditions and messages are listed as follows General fault conditions are listed in Table 10 2 Sample Related fault condit...

Page 466: ...10 32 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Troubleshooting and Diagnostics Instrument Conditions and Messages Section 10 NOTES ...

Page 467: ...anged to correct out of range values BL 10 35 Entries making upper limit lower limit were rejected BL 10 35 Limits were exchanged to make upper lower BL 10 35 Westgard Warning See Levey Jennings BL 10 35 No Entry Found BL 10 36 Duplicated Specimen ID on the new line BL 10 36 Sample Loader is busy BL 10 36 Change Sampler in Ready State Only BL 10 36 Change Sampler when Sample Loader is not busy BL ...

Page 468: ...ally performing a cleaning cycle before entering the STANDBY state Pressing the DAILY SHUTDOWN key also initiates this message When the cycle is finished press RUN to prime the system and bring the instrument to the READY state Resume operation when the cycle is finished Standby SB Explanation Action The instrument has entered the STANDBY state Press RUN or PRIME to prime the system and bring the ...

Page 469: ...Entries making upper limit lower limit were rejected BL Explanation Action A mathematically incorrect limit was entered using RANGE ENTRY during setup of a QC file The currently entered numbers are not accepted and the previously entered numbers for the parameter s remain Check to be sure the entered values are correct Limits were exchanged to make upper lower BL Explanation Action A mathematicall...

Page 470: ...ation Action An action was requested during Sample Loader operation and the Sample Loader cannot perform it Press the STOP LOADER soft key before requesting the desired action Change Sampler in Ready State Only BL Explanation Action The CHANGE SAMPLER key was pressed while the Analyzer was busy The CHANGE SAMPLER key can only be pressed when the Analyzer is in the READY state Change Sampler when S...

Page 471: ... press the START LOADER key Loader Warning 146 unload area nearly full BL Explanation Action The unload area contains 4 racks No corrective action is necessary If a rack is being processed and there are no other faults the Sample Loader will continue to operate Loader Status 158 load zone empty BL Explanation Action The load zone empty sensor is not sensing the presence of a rack in the load zone ...

Page 472: ...AM BL 10 48 Bad monitor command BL 10 48 Message retransmission failure BL 10 49 HSSL failure bad incoming messages BL 10 50 HSSL failure bad outgoing commands BL 10 51 HSSL failure receiver hardware error BL 10 52 Monitor power on self test error BL 10 52 Missing download program BL 10 53 Missing flow sequence BL 10 53 Invalid substitutable parameter BL 10 53 DMA controller error during list mode...

Page 473: ... 10 67 Tower Fault 49 tower cover open BL 10 68 Tower Fault 50 probe stuck at home position BL 10 69 Tower Fault 100 probe unable to reach home position BL 10 70 Tower Fault 141 invalid tube height BL 10 71 Tower Fault 142 no tube present BL 10 72 Loader Warning 144 excessive cycling BL 10 73 Loader Fault 147 unload area hardware malfunction BL 10 74 Loader Fault 148 tube dropped during mixing BL ...

Page 474: ...Analyzer status indicator panel is illuminated in red Probable Cause Corrective Action 1 A situation that prevents the READY state has been detected See the DIAGNOSTICS MENU screen or the SPECIAL PROTOCOLS MENU screen whichever is indicated for more information 1 From the first DIAGNOSTICS MENU screen press FAULT REPORT followed by PRINT to obtain a printout describing the problem Refer to the app...

Page 475: ...rt Center Initialization Failed Bottom of screen MAIN MENU is not displayed Probable Cause Corrective Action 1 The instrument software was unable to initialize The CELL DYN software does not display the MAIN MENU screen 1 Initialize the Analyzer by following the instructions in the Power OFF and Power ON procedures given in Section 5 Operating Instructions Subsection Operation Overview If the Anal...

Page 476: ... line indicator is illuminated If necessary refer to the printer manual for assistance 4 The power cord is loose or disconnected The interface cable is loose or disconnected 4 Check the power cable connection on the printer and power outlet Make sure the connections are secure Check the interface cable connectors on the printer and Analyzer Make sure the connections are secure Press PRINT REPORT I...

Page 477: ...ve liquid is connected to the inlet tube 4 Check the label on the reagent container to be sure the correct reagent is installed Trace the line to the inlet connector and ensure that it is connected to the correct one Check the connection to be sure it is secure and then press CLEAR FAULT 5 Appropriate syringe not mounted properly 5 Check proper mounting of syringes 6 The Luer fitting connection on...

Page 478: ...he waste cap 3 Visually inspect wires and electrodes and call for technical assistance 4 Circuitry malfunction 4 If the message appears repeatedly contact your Abbott Hematology Customer Support Center Shear valve position fault BL Probable Cause Corrective Action 1 The Shear Valve did not rotate properly or in the allotted time 1 Clean the Shear Valve Then initialize the Analyzer by pressing the ...

Page 479: ...brackets make sure the syringes stay connected to the Luer fittings and initialize the Analyzer 4 Clean the 10 mL syringe 5 Clean the Shear Valve 6 Verify tubing in solenoids 26 and 27 is not pinched replace if necessary 7 If still unable to resolve the problem contact Hematology Customer Support Center Vacuum accumulator 1 wet BL Vacuum accumulator 2 wet BL Probable Cause Corrective Action 1 The ...

Page 480: ...by pressing the INITIALIZATION key on the second DIAGNOSTICS MENU screen Continue processing samples 3 If the problem recurs contact your Abbott Hematology Customer Support Center Command sent at incorrect time x BL Probable Cause Corrective Action 1 The Analyzer received a command from the System Software at the incorrect time and could not process it 1 Record the characters in the brackets 2 Ini...

Page 481: ...r Support Center List mode data phase error BL Probable Cause Corrective Action 1 The order of the data received for display on the screen was incorrect 1 Record what happened when the message was displayed 2 Initialize the Analyzer by pressing the INITIALIZATION key on the secondDIAGNOSTICS MENUscreen Continue processing samples 3 If the fault recurs contact your Abbott Hematology Customer Suppor...

Page 482: ...bable Cause Corrective Action 1 When the system was powered ON the Analyzer did not transmit the correct message to the Data Module 1 Power OFF and ON again 2 If the fault recurs contact your Abbott Hematology Customer Support Center Bad monitor command BL NOTE This message pertains to a software execution monitor on the Analyzer not the video display screen CRT Probable Cause Corrective Action 1 ...

Page 483: ... 1 A hardware failure or system error has occurred 1 Initialize the Analyzer by pressing the INITIALIZATION key on the second DIAGNOSTICS MENU screen If the message appears again reboot the System NOTE If you wish to use the Sample Loader reset the racks before initializing or rebooting the System 2 If the message appears repeatedly contact your Abbott Hematology Customer Support Center Table 10 2...

Page 484: ...tialize the Analyzer by pressing the INITIALIZATION key on the second DIAGNOSTICS MENU screen If the message appears again power OFF the Analyzer Then reseat both ends of HSSL cable and make sure the connections are secure Power Analyzer ON NOTE For the location of the HSSL connectors on the rear panel of the Data Module refer to Section 1 Use or Function Subsection Data Module Components NOTE If ...

Page 485: ...ATION key on the second DIAGNOSTICS MENU screen If the message appears again power OFF the Analyzer Then reseat both ends of HSSL cable and make sure the connections are secure Power Analyzer ON NOTE For the location of the HSSL connectors on the rear panel of the Data Module refer to Section 1 Use or Function Subsection Data Module Components NOTE If you wish to use the Sample Loader reset the ra...

Page 486: ...nel of the Data Module refer to Section 1 Use or Function Subsection Data Module Components NOTE If you wish to use the Sample Loader reset the racks before initializing or rebooting the System 2 If the message appears repeatedly contact your Abbott Hematology Customer Support Center Monitor power on self test error BL NOTE This message pertains to a software execution monitor on the Analyzer not ...

Page 487: ... not present on Data Module Probable Cause Corrective Action 1 Installation error damaged hard disk or erased hard disk 1 Reboot the System NOTE If you wish to use the Sample Loader reset the racks before rebooting the System 2 If the message appears repeatedly contact your Abbott Hematology Customer Support Center Invalid substitutable parameter BL Size or structure of parameter e g gain is inval...

Page 488: ... If you wish to use the Sample Loader reset the racks before initializing or rebooting the System 2 If the message appears repeatedly contact your Abbott Hematology Customer Support Center DMA controller setup error BL A problem occurred during setup of the memory access controller Probable Cause Corrective Action 1 A failure in the Analyzer hardware has occurred 1 Initialize the Analyzer by press...

Page 489: ...Check the HSSL cable connections Then initialize the Analyzer by pressing the INITIALIZATION key on the second DIAGNOSTICS MENU screen If the message appears again reboot the System NOTE For the location of the HSSL ports refer to Section 1 Use or Function Subsection Data Module Components NOTE If you wish to use the Sample Loader reset the racks before initializing or rebooting the System 2 If th...

Page 490: ...mmand transmission timeout The Data Module did not receive acknowledgment of a command sent to the Analyzer within the allotted time Probable Cause Corrective Action 1 A failure in the Analyzer hardware possibly due to an unplugged or damaged HSSL cable has occurred 1 Check the HSSL cable connections Then initialize the Analyzer by pressing the INITIALIZATION key on the second DIAGNOSTICS MENU scr...

Page 491: ...nction Subsection Data Module Components NOTE If you wish to use the Sample Loader reset the racks before initializing or rebooting the System 2 If the message appears repeatedly contact your Abbott Hematology Customer Support Center Data acquisition timeout BL The Analyzer exceeded the allotted time for data acquisition Probable Cause Corrective Action 1 An Analyzer or Data Module software timing...

Page 492: ...icating whether it is an SL or CS model Probable Cause Corrective Action 1 An Analyzer software setup error has occurred 1 Reboot the System NOTE If you wish to use the Sample Loader reset the racks before rebooting the System 2 If the message appears repeatedly contact your Abbott Hematology Customer Support Center Tower Loader Fault 3 transmission failure BL A transmission acknowledgment failure...

Page 493: ...Sample Loader reset the racks before rebooting the System 2 If the message appears repeatedly contact your Abbott Hematology Customer Support Center Tower Loader Fault 16 direct command parameter error BL The Analyzer command given to the module that controls the tower and loader is invalid Probable Cause Corrective Action 1 A software error has occurred 1 Reboot the System NOTE If you wish to use...

Page 494: ...and if one is found remove it Reboot the System NOTE If you wish to use the Sample Loader reset the racks before rebooting the System 2 If the message appears repeatedly contact your Abbott Hematology Customer Support Center Tower Loader Fault 18 invalid direct command BL The Analyzer command given to the module that controls the tower and loader is invalid Probable Cause Corrective Action 1 A sof...

Page 495: ...ck in angle position BL The Mix Head failed to return to its vertical position Probable Cause Corrective Action 1 A mechanical problem is preventing the Mix Head from rotating downward 1 Remove the Loader Cover Check for an obstruction that is preventing the Mix Head from rotating downward If an obstruction is found remove it and rotate the Mix Head to its vertical position Reinstall the Loader Co...

Page 496: ...f the magnetic reed sensor or related electronics has occurred 2 If the message appears repeatedly contact your Abbott Hematology Customer Support Center Loader Fault 42 mix head not at top position BL The Mix Lift Assembly failed to reach its top position Probable Cause Corrective Action 1 A mechanical problem is preventing Mix Lift Assembly is from moving upward 1 Remove the Loader Cover Check f...

Page 497: ...tact your Abbott Hematology Customer Support Center Loader Fault 44 load zone empty detector malfunction The system failed to retract mechanical arms after detecting that the load zone is empty NOTE This fault does not lead to a Sample Loader halt because any rack currently in the mixing zone is unaffected Probable Cause Corrective Action 1 A mechanical problem has prevented the rack arms in the l...

Page 498: ...hanics has occurred 2 If the message appears repeatedly contact your Abbott Hematology Customer Support Center Loader Fault 46 unload zone nearly full detector malfunction BL The system is detecting an unload zone nearly full condition 4 racks in unload zone even though there are fewer than 4 racks in the unload zone Probable Cause Corrective Action 1 A mechanical problem has prevented the rack ar...

Page 499: ...n order CLEAR FAULT START LOADER RESET LOADER b The tube in position 3 either has a loose bar code label or too many bar code labels b If the bar code label is loose secure it in place If multiple bar code labels are on the tube remove them and carefully apply a single bar code label Then reset the racks and reset the Sample Loader NOTE For information concerning proper application of bar codes re...

Page 500: ...with lens cleaner or deionized water clean the tube sensors the tube position 3 sensor is on the right Dry the sensors thoroughly Then reinstall the Loader Cover reset the racks and reset the Sample Loader NOTE For the location of the tube sensors refer to the figure in Section 13 Sample Loader Subsection Processing Stations 3 A failure of the sensor or related electronics has occurred 3 If the me...

Page 501: ...loose bar code label or too many bar code labels b If the bar code label is loose secure it in place If multiple bar code labels are on the tube remove them and carefully apply a single bar code label Then reset the racks and reset the Sample Loader NOTE For information concerning proper application of bar codes refer to Section 13 Sample Loader Subsection Bar Code Label Placement c the Mix Head T...

Page 502: ...tations 3 A failure of the sensor or related electronics has occurred 3 If the message appears repeatedly contact your Abbott Hematology Customer Support Center Tower Fault 49 tower cover open BL The circuit formed when the Tower Cover is in place has been broken Probable Cause Corrective Action 1 The Tower Cover has been removed or is not seated properly 1 Reinstall or reset the Tower cover Make ...

Page 503: ...on on the Aspiration Tower 1 Remove the Loader Cover Check for an obstruction on the Aspiration Tower that is preventing the probe from leaving the home position and if one is found remove it Then reinstall the Loader Cover reset the racks and reset the Sample Loader by pressing the following keys in order CLEAR FAULT START LOADER RESET LOADER 2 A failure of the sensor or related electronics has o...

Page 504: ... reaching the home position on the Aspiration Tower 1 Remove the Loader Cover Check for an obstruction on the Aspiration tower that is preventing the probe from reaching the home position and if one is found remove it Then reinstall the Loader Cover reset the racks and reset the Sample Loader by pressing the following keys in order CLEAR FAULT START LOADER RESET LOADER 2 A failure of the sensor or...

Page 505: ...ULT START LOADER RESET LOADER NOTE For tube height specifications refer to Section 13 Sample Loader Subsection Physical and Performance Specifications 2 Failure of the sensor or related electronics has occurred 2 Reset the racks and reset the Sample Loader 3 The tube height sensor or sensor flag on the Tower is not moving into position properly a The Guide Shafts are dirty 3 The tube height sensor...

Page 506: ...is bent or the tower sensors motor or related electronics are defective c Contact your Abbott Hematology Customer Support Center Tower Fault 142 no tube present BL The tube height sensor did not sense a tube when one was expected Probable Cause Corrective Action 1 The tube being processed is too short 1 To run the sample in the Sample Loader pour the sample into a tube without anti coagulant that ...

Page 507: ...n that is preventing the rack arms from extending and holding the racks against the loader wall so the racks can engage with the rack advance mechanism If an obstruction is found remove it Then reset the racks and reset the Sample Loader by pressing the following keys in order CLEAR FAULT START LOADER RESET LOADER 3 Both tube sensors are dirty 3 Remove the Loader Cover Using a DYN A WIPE pad or li...

Page 508: ...se Corrective Action 1 One or more racks did not move properly in the unload area 1 Check for an obstruction that is preventing rack movement in the unload area and if one is found remove it Then reset the racks and reset the Sample Loader by pressing the following keys in order CLEAR FAULT START LOADER RESET LOADER 2 A failure of the sensor system or related electronics has occurred 2 Reset the r...

Page 509: ...istened with a 0 5 sodium hypochlorite solution clean the Mix Head Tube Gripper See the formula for mixing this solution under Section 9 Service and Maintenance Subsection Decontamination Procedures Repeat with deionized water Then reinstall the Loader Cover reset the racks and reset the Sample Loader 2 A failure of the sensor system or related electronics has occurred 2 Remove the Loader Cover Us...

Page 510: ...bstruction that is preventing the rack from advancing and if one is found remove it b The rack and or Sample Loader Tray are dirty b Remove the Loader Cover Using a DYN A WIPE pad or lint free wipe moistened with deionized water clean the rack and Sample Loader Tray Then reinstall the Loader Cover reset the racks and reset the Sample Loader by pressing the following keys in order CLEAR FAULT START...

Page 511: ...ened with deionized water clean the rack and Sample Loader Tray Then reinstall the Loader Cover reset the racks and reset the Sample Loader by pressing the following keys in order CLEAR FAULT START LOADER RESET LOADER c A failure of the Air Cylinder or the Air Cylinder pressure system has occurred c If the message appears repeatedly contact your Abbott Hematology Customer Support Center 2 Tube sen...

Page 512: ... wipe moistened with lense cleaner or deionized water clean the rack and Sample Loader Tray Then reinstall the Loader Cover reset the racks and reset the Sample Loader by pressing the following keys in order CLEAR FAULT START LOADER RESET LOADER c A failure of the Air Cylinder or the Air Cylinder pressure system has occurred c If the message appears repeatedly contact your Abbott Hematology Custom...

Page 513: ...DER RESET LOADER 2 There is an obstruction at tube position 4 that is activating the sensor 2 Remove the Loader Cover Check for an obstruction at tube position 4 that is activating the sensor and if one is found remove it Then reinstall the Loader Cover reset the racks and reset the Sample Loader 3 Tube sensor in position 4 is dirty 3 Remove the Loader Cover Using a DYN A WIPE pad or lint free wip...

Page 514: ...Reader thoroughly Then reinstall the Loader Cover reset the racks and reset the Sample Loader by pressing the following keys in order CLEAR FAULT START LOADER RESET LOADER NOTE For the location of the Bar Code Reader refer to Section 13 Sample Loader Subsection Sample Loader Description 2 The first rack bar code label is missing scuffed or dirty 2 Clean or replace the rack bar code label Then rese...

Page 515: ...ized water clean the window on the Bar Code Reader Dry the window on the Bar Code Reader thoroughly Then reinstall the Loader Cover reset the racks and reset the Sample Loader by pressing the following keys in order CLEAR FAULT START LOADER RESET LOADER NOTE For the location of the Bar Code Reader refer to Section 13 Sample Loader Subsection Sample Loader Description 2 The tube position bar code l...

Page 516: ...Reader Dry the window on the Bar Code Reader thoroughly Then reinstall the Loader Cover reset the racks and reset the Sample Loader by pressing the following keys in order CLEAR FAULT START LOADER RESET LOADER 2 The rack and tube position bar code labels are not present or are unreadable 2 Replace the rack and tube position bar code labels with new labels Then reset the racks and reset the Sample ...

Page 517: ...on Page Sampling Error Incomplete Aspiration BL 10 84 3 consecutive incomplete aspirations BL 10 85 WOC Flow Error BL 10 85 NOC Flow Error BL 10 86 RBC Flow Error BL 10 87 3 consecutive WOC flow errors BL 10 87 3 consecutive NOC flow errors BL 10 87 3 consecutive RBC flow errors BL 10 87 In Place of Results for WBC RBC HGB or PLT 10 88 High Rate of False Flagging 10 88 ...

Page 518: ...HC result SAMPLING ERR is printed on all reports Results may look like background counts Probable Cause Corrective Action 1 The blood sensor system did not detect a sufficient amount of sample at the expected time following aspiration 1 Check the sample tube to be sure it contains a sufficient quantity of blood Verify that the sample contains no clots 2 Clean the Open Sample Probe or the Closed Sa...

Page 519: ...n the RUN screen The Sample Loader continues processing 3 If unable to resolve this problem contact your Abbott Hematology Customer Support Center WOC Flow Error BL WOC FLOW ERROR is displayed on the RUN screen to the right of the EOS results WOC FLOW ER is printed on the graphics report to the right of the NEU result Results for WBC and Differential are suppressed Probable Cause Corrective Action...

Page 520: ...essed Probable Cause Corrective Action 1 An increasing NOC count rate was detected in the optical flow cell during the NOC measurement 1 Repeat the sample 2 Optical flow cell is dirty or contains bubbles 2 Empty refill flow cell in Special Protocols Run AutoClean and or Extended AutoClean 3 Sample Dilution Delivery Problem 3 Check replace tubing in Sample Transfer Pump Clean Sample Injection Syrin...

Page 521: ...lean and or Extended AutoClean 3 Sample Dilution Delivery Problem 3 Check replace tubing in Sample Transfer Pump Clean Sample Injection Syringe check for leakage and replace as necessary 4 Diluent Sheath flow partially obstructed 4 Replace Diluent Sheath Filter 3 consecutive WOC flow errors BL 3 consecutive NOC flow errors BL 3 consecutive RBC flow errors BL Probable Cause Corrective Action 1 Thre...

Page 522: ... operation and check reagent Inlet Lines for crimping High Rate of False Flagging High number of false flags displayed on the RUN screen Probable Cause Corrective Action 1 Dirty Diluent Sheath Filter 1 Replace Diluent Sheath Filter 2 Contaminated WBC Lyse 2 Replace WBC Lyse reagent Clean WBC lyse syringe 3 Dirty optical flow cell 3 In SPECIAL PROTOCOLS menu follow procedure for emptying and refill...

Page 523: ...dicator light on the Analyzer status indicator panel is illuminated in red 10 92 The message Please check signal cable appears on the Display Monitor 10 92 Background count is outside acceptable limits 10 93 The PC keyboard is not operational 10 94 The Sample Loader does not respond when the START LOADER RESUME or RESET key is pressed 10 94 The Sample Loader beeps but does not begin processing 10 ...

Page 524: ... power ON Probable Cause Corrective Action 1 Power cord is not securely connected to the Analyzer or is not connected to the power outlet 1 Ensure that the power cord is securely connected to the Analyzer and verify that it is connected to the power outlet 2 Power source is defective 2 Turn the power switch OFF and connect the system to a different power source Turn the power switch ON 3 Analyzer ...

Page 525: ...or brightness control is turned down 2 Adjust the brightness control under the front control panel of the Display Monitor until the image is visible 3 The Display Monitor interface connector VGA 25 pin is not securely connected 3 Locate the connector on the rear panel of the Data Module reseat the cable and secure the connection properly NOTE For the location of the VGA connector refer to Section ...

Page 526: ...ted corrective action When the action is completed initialize the Analyzer by pressing the INITIALIZATION key on the second DIAGNOSTICS MENU screen 2 If the fault report does not indicate a message or action document the situation and initialize the Analyzer by pressing the INITIALIZATION key on the second DIAGNOSTICS MENU screen The message Please check signal cable appears on the Display Monitor...

Page 527: ...t 2 The reagents are cold less than 59 F 15 C 2 Allow the reagents to warm to room temperature and then repeat the Background count 3 The reagents are contaminated 3 Replace the appropriate reagent according to the directions given in TroubleshootingReagentProblems cited earlier in this section 4 Diluent Sheath filter is dirty 4 Replace Diluent Sheath filter 5 Syringes are the source of contaminat...

Page 528: ...x message 5 Computer keyboard and or circuitry malfunction 5 Power OFF the Analyzer Then reset the Keyboard cable on the rear panel of the Data Module and power Analyzer ON NOTE For the location of the keyboard connector refer to Section 1 Use or Function Subsection Data Module Components If necessary contact your Abbott Hematology Customer Support Center The Sample Loader does not respond when th...

Page 529: ...ys are not operational Probable Cause Corrective Action 1 The computer is performing a function that inhibits the keys 1 No action required Wait for the computer to resume the operation Refer to the screen for the current Status Box message 2 There is an incomplete operator entry 2 Complete the operator entry or press the ESC key on PC keyboard 3 A data transmission to the printer or laboratory co...

Page 530: ...10 96 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Troubleshooting and Diagnostics Tables for Instrument Conditions and Messages Section 10 NOTES ...

Page 531: ...ile is used to calculate the mean standard deviation and coefficient of variation Westgard Rules A multi rule system applied to the data in each of the QC Files to detect drift and imprecision and to detect systematic or random error The above options may be used independently or in combination depending on the operator s preference Each option is discussed in detail in this section Quality Contro...

Page 532: ...11 2 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Quality Control Overview Section 11 NOTES ...

Page 533: ...ure 11 1 and the QC SET UP menu Refer to Set Up QC File in Section 5 Operating Instructions for an explanation of these keys as they will not be discussed in this section Figure 11 1 Quality Control Menu Screen The following soft key labels are displayed when the QUALITY CONTROL key on the MAIN MENU screen is pressed X B SET UP X B FILE VIEW QC LOG QC LIMITS SET UP QC FILE CUSTOMIZE DISPLAY CUSTOM...

Page 534: ... Menu Section 11 X B Set Up Figure 11 2 X B Set Up Screen The following soft key labels are displayed when the X B SET UP key is pressed refer to Figure 11 2 TURN X B RBC OFF Key label alternates between ON OFF selections TURN X B WBC OFF Key label alternates between ON OFF selections PRINT RETURN ...

Page 535: ...w Graphs When the X B RBC GRAPHS key or X B WBC GRAPHS key is pressed the X B GRAPHS DISPLAY screen for the appropriate parameter is displayed Refer to Figure 11 3 Show Data When the X B RBC DATA key or X B WBC DATA is pressed the X B DATA DISPLAY screen for the appropriate parameter is displayed This screen is depicted in Figure 11 4 The screen displays the results for X B batches 1 10 and the lo...

Page 536: ...1 Figure 11 4 X B RBC Data Screen Print The PRINT key is used to print the X B data or graphs When this key is pressed the data for all 20 batches is automatically printed if the data is displayed If the graphs are displayed all ten of them are printed Return The RETURN key is used to return to the QC MENU screen ...

Page 537: ...the file was configured for a REPLICATE ID it is displayed instead of the lot number and expiration date File name the number of runs currently in the file and the file capacity e g 39 120 indicates that the file contains 39 runs out of a possible 120 The page number of the display and the total number of pages in the file 2 Status Box USE OR FOR MORE DATA This message indicates that the Left and ...

Page 538: ...ample was run in the Closed mode N Incomplete aspiration in the Open mode I Incomplete aspiration in the Closed mode K Flow Error occurred Background and latex samples use only the O or C codes 6 The statistics are displayed below the data as follows N the Number of runs used in the calculation FILE MEAN the Mean value for the number of runs used in the calculation STD DEV the Standard Deviation 1...

Page 539: ...VEY JENNINGS key is used to display the Levey Jennings graphs of the data in the QC file Refer to Figure 11 6 The following soft key labels are displayed when the LEVEY JENNINGS key is pressed The soft key for the group being displayed will not be shown GROUP 1 GROUP 2 GROUP 3 GROUP 4 PREVIOUS 10 NEXT 10 PRINT RETURN Figure 11 6 The Levey Jennings Menu Screen If there are sufficient specimens in t...

Page 540: ...en is not displayed Print The PRINT key is used to print the Levey Jennings graphs When the PRINT key is pressed all of the graphs are automatically printed Return The RETURN key is used to return to the VIEW QC LOG screen Reject Accept Specimen The REJECT SPECIMEN key is used to exclude the results for the specimen indicated by the cursor position When the key is pressed the key label changes to ...

Page 541: ...e following key labels are displayed CONFIRM DELETION CANCEL DELETION These keys are used to CONFIRM or CANCEL the delete command When the CONFIRM DELETION key is pressed the results are deleted from the file the data is not displayed or stored in the file and the statistics are recomputed excluding those results Move Specimen The MOVE SPECIMEN key is used to move a QC result indicated by the curs...

Page 542: ...layed showing that the results have been moved Write QC to Disk The WRITE QC TO DISK key enables the download of data from a QC file s to a floppy disk NOTE The LAB ID SET UP must be completed prior to downloading QC data onto a disk Refer to Section 5 Operating Instructions Subsection Set Up Instructions Write QC to Disk Procedure 1 Place an appropriately labeled blank diskette in the disk drive ...

Page 543: ... disk can store one QC file of each level If more than one QC file of each level is saved the new data will overwrite the previous data 9 Remove the disk from the disk drive and send it to the CELL DYN Interlaboratory QC program for evaluation Print QC Log The PRINT QC LOG key is used to print the entire QC log Return The RETURN key is used to return to the QC MENU screen ...

Page 544: ...11 14 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Quality Control Quality Control Menu Section 11 NOTES ...

Page 545: ...amples that were previously found to be within set patient limits CELL DYN Controls provide three control levels low normal and high ranges for each measured parameter All QC data should be reviewed according to your laboratory s protocol Refer to the section on Westgard Rules for suggestions on how to use these rules in a review protocol Refer to the section on X B Analysis for suggestions and gu...

Page 546: ...tor defined limits or reportable range reconfirm calibration for that parameter using specimens with known reference values When calibration confirmation results are acceptable establish a new working mean and limits for each level of the new lot of control A control file should be set up for the new lot number to easily establish the mean If desired this sample control file can then be used to ru...

Page 547: ...in both operating modes Open or Closed Always do the following If the System has been idle for 15 minutes or more run a background immediately prior to running a control specimen Follow the proper warming and mixing procedures previously described including those located on the control package insert Run control samples for each measured parameter in the same manner as patient samples Verify that ...

Page 548: ...ied Westgard rules may be used to monitor quality control results on the CELL DYN 3200 NOTE Do not use the values for mean range listed on the commercial control s assay sheet in conjunction with Westgard Rules Before using Westgard Rules with commercial controls establish the SD for each parameter on your instrument Enter limits based on 2SDs For Westgard Rules control limits are assumed to be 2S...

Page 549: ...TGARD WARNINGS SEE LEVEY JENNINGS The number of the rule that was violated is displayed in place of the plus sign Figure 11 9 shows examples of the plus signs and rule violation indications Rule Violations Only the directly measured parameters need to be monitored with multiple rules 4 In reference 4 pp 190 192 Cembrowski suggests a protocol for using the Westgard rules in hematology The following...

Page 550: ...t file If a combination of rules has been violated across the three levels determine whether the violations indicate a loss of precision or a loss of accuracy and troubleshoot accordingly If necessary call the Abbott Hematology Customer Support Center for assistance When the problem has been resolved Cembrowski suggests that all levels be run again in duplicate to confirm that it has in fact been ...

Page 551: ...pleted and a new batch is started with the next included specimen 5 Specimens in a current batch are identified with an X B flag in the Data Log The number of specimens in a current batch either RBC or WBC is shown on the RUN screen under the Status Box in the fields XBRBC X IN and XBWBC X IN where X is a number from 0 to 20 6 When the X B program is first turned from OFF to ON the number of recor...

Page 552: ...Each RBC batch has three means one each for MCV MCH and MCHC These means are updated whenever a new specimen is added to or removed from a batch 18 Each WBC batch has 7 means one each for LYM OD LYM 10D NEU 0D NEU 10D NEU 90D NEU 90DEP and NEU EO These means are updated whenever a new specimen is added to or removed from a batch 19 If the current batch has 1 or more batch means outside the target ...

Page 553: ... X B RBC Target Value A recent study6 by Dr Bull collected data from 1 767 hospitals and yielded the following mean values MCV 89 9 fL MCH 30 5 pg MCHC 33 9 g dL These values confirmed values that Bull had published in an earlier study 7 Consequently the values shown above can be used as the Target Values to initiate the X B analysis program Laboratories seeing specialized patient populations for ...

Page 554: ...h of 20 may also cause a non random population in that batch Review the Data Log for the last 20 specimens and determine if this is the case Shifts caused by non random data will usually be corrected in the next batch of 20 as long as those data are random Shifts may also be caused by a change in reagent container or a lot number change If containers or lot numbers recently changed try another con...

Page 555: ...catterplots It is expected that these optical characteristics of the WBC Differential subpopulations will remain stable over time without impact from the wide dynamic ranges of the individual parameters This constant modal position which is sensitive to changes in the instrument s optical measurement process can be monitored by the instrument and used to control the WBC Differential parameters in ...

Page 556: ... print the X B DATA DISPLAY screen for WBC Calculate the mean standard deviation SD and coefficient of variation CV for each parameter The CV for LYM 0 LYM 10 NEU 0 and NEU 10 should be 2 5 The CV for NEU 90 NEU 90 depolarized and NEU EOS should be 5 If the CV for each index meets these criteria enter the calculated mean value as the target value and set the action limits to 5 for LYM 0 LYM 10 NEU...

Page 557: ...e 1989 418 421 4 Cembrowski GS Carey RN Laboratory quality management P 190 5 Bull BS Korpman RA Intralaboratory quality control using patients data In Cavill I ed Quality Control Edinburgh Churchill Livingstone 1982 121 150 6 Bull BS Jones AR Gibson M Twedt D A method for the independent assessment of the accuracy of hematology whole blood calibrators AJCP accepted for publication 1992 7 Bull BS ...

Page 558: ...11 28 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Quality Control References Section 11 NOTES ...

Page 559: ...ted on command by the operator The Ticket Printer can be used to print reports with graphic information in black only but the connection to the Analyzer must be changed IMPORTANT The CELL DYN 3200 System has been configured for and tested on the following printers Canon BJC 620 and BJC 4300 4400 and Epson 800 850 888 color ink jet printers for graphics output and OKIDATA MICROLINE 320 dot matrix p...

Page 560: ...12 2 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Printers Overview Section 12 NOTES ...

Page 561: ...laten Be sure to remove any loose particles of paper Do not use solvents or strong detergents on the cabinet Troubleshooting Refer to the printer manuals for a list of the most common printer problems and how to solve them If the problem is not resolved contact the Abbott Hematology Customer Support Center for assistance If during routine system operation the message PRINTER UNAVAILABLE is display...

Page 562: ...12 4 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Printers Maintenance and Troubleshooting Section 12 NOTES ...

Page 563: ... graphics report the printer cable must be connected to the Graphics Printer connector on the back of the Data Module Printing Tickets To print tickets the printer cable must be connected to the Ticket Printer connector on the back of the Data Module See Figure 2 5 for the location of these connectors Refer to Section 2 Installation Procedures and Special Requirements Subsection Printer Installati...

Page 564: ...e TOF Quiet key and pressing the Form Feed key to move the ticket up or pressing the Line Feed key to move the ticket down The ticket moves in very fine increments so it can be precisely positioned NOTE The ticket will only move down to a certain point to prevent potential ticket jams Do not move the top of the page below the paper bail 9 Position the ticket so that the lower red line on the paper...

Page 565: ...on and the loader s operational status to the CELL DYN 3200SL The sample tubes in an upright position are transported in racks Up to 50 tubes can be loaded onto the Sample Loader and processed with or without bar code labels The Sample Loader has been designed to provide fast and efficient throughput of patient samples Used in conjunction with the Work List and Bar Codes the Sample Loader can proc...

Page 566: ...13 2 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Sample Loader Overview Section 13 NOTES ...

Page 567: ... lbs 8 1 kg Tube Types The Closed Sample Tower Module and the Sample Loader are able to accommodate the following tube types 1 Beckton Dickinson Type B D Hemogard Stopper 5 0 mL B D Rubber Stopper 5 0 mL Greiner 4 0 mL Terumo Venoject II 5 0 mL 2 Sarstedt Type Sarstedt EDTA 2 7 mL Sarstedt Neutral 2 7 mL NOTE All other tube types must be processed in the Open mode Rack and Tube Capacity 5 racks on...

Page 568: ...13 4 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Sample Loader Physical and Performance Specifications Section 13 NOTES ...

Page 569: ...cting the Sample Loader with the Analyzer are installed at the factory and should not be removed The Sample Loader consists of four main assemblies Sample Transport Assembly Sample Tube Sensing Assembly Sample Mixing Assembly and Bar Code Reader These components are depicted in Figure 13 2 The Tube Sensor Assembly is located on the Sample Loader chassis directly behind Stations 1 and 2 NOTE Severa...

Page 570: ...tepper motor The Bar Code Reader is an LED type and can accommodate the following formats Code 39 Code 128 CODABAR and Interleaved 2 of 5 On the SL model the Bar Code Reader is located on the Sample Loader directly in front of the aspiration needle spinner assembly A Power Cable connecting the Sample Loader with the Analyzer provides power from the Analyzer to the loader An Interface Cable connect...

Page 571: ...re 13 4 Bar code labels on tube racks are essential for proper Sample Loader operation The rack label must be placed on each rack ahead of tube position 1 This label serves to identify the rack and tube position 1 The rack bar code label is read when the tube in the first position is moved from Mixing Station 2 to the Aspiration Station Subsequent bar code labels on the rack identify tube position...

Page 572: ...181H October 2001 Sample Loader Sample Loader Description Section 13 Figure 13 4 Rack with Bar Code Labels NOTE Tube bar code labels must be 3 digits Rack labels must include Code 39 The Rack ID must be 2 digits and the rack position must be 1 digit ...

Page 573: ... 9140181H October 2001 Section 13 Sample Loader RUN Screens The RUN Screens for the CELL DYN 3200SL model shown in Figures 13 5 and 13 6 are slightly different from the screen for the CELL DYN 3200CS model Figure 13 5 CELL DYN 3200SL RUN Screen ...

Page 574: ...3 5 NOTE The CLEAR FAULT key will appear in the first position whenever a Fault condition occurs 2 A submenu that appears under certain conditions when the START LOADER key is pressed refer to Figure 13 6 Pressing the START LOADER key activates the Sample Loader and toggles to STOP LOADER without an intervening submenu under the following two conditions 1 When the System has been initialized or wh...

Page 575: ...CLEAR FAULT and START LOADER keys are pressed one of two possible submenus will be displayed Refer to Sample Loader Faults later in this section for an explanation The operator must decide which key to press to re activate the Sample Loader based on whether or not the rack under the Tower was moved Pressing either RESUME LOADER or RESET LOADER will activate the Sample Loader and display the main R...

Page 576: ... LOADER key in the first position Fault Conditions On the SL model there are two sources of fault conditions Instrument related faults Data Module or Analyzer and Sample Loader only faults Data Module Analyzer Faults Faults related to the Data Module or Analyzer may be either operator correctable or fatal If the fault is operator correctable when START LOADER is pressed the RESTART menu is display...

Page 577: ...k and Mixing Station 2 corresponds to the second tube gripper Station 1 First Mixing A sensor detects the presence of a tube and activates the mixer The sample is mixed in a 135 rotation for approximately 40 seconds Station 2 Second Mixing A second sensor detects the presence of a tube and activates the mixer The sample is again mixed in a 135 rotation for approximately 40 seconds NOTE Several Sam...

Page 578: ...starting position for a rack Load Side A set of mechanical arms on the load side pushes the racks forward toward the Analyzer If the arms do not sense a rack on the load side the Sample Loader emits 3 beeps to alert the operator and displays a message on the Bulletin line stating Loader Status 158 load zone empty Additionally when the last rack has been processed the message Loader Status 143 Samp...

Page 579: ...ation the tube advances to the Aspiration Station where it is vented and aspirated When the 6th tube is at Station 3 aspiration the next rack on the load side is pushed forward in preparation for processing Racks continue moving to the preparation position until either the load side is empty or the unload side is full After the last tube in a rack has been processed the rack continues moving until...

Page 580: ...ng with that rack s movement through the Mixing and Aspiration Stations If the unload side is full 5 racks and a 6th rack is being processed the 6th rack can advance until the 6th tube position is at the Aspiration Station refer to Figure 13 9 If position 6 has a sample then that sample can be processed When processing is completed for that sample the Sample Loader will emit 3 beeps to alert the o...

Page 581: ...thout bar code labels for sample identification Normally non bar coded samples should not be removed from the racks until all samples have been processed since the rack and tube number of each sample is important for positive sample identification If the rack being processed under the Tower Cover must be removed before processing is completed for example the system must be re initialized to clear ...

Page 582: ...e START LOADER soft key appears and you should press it to start the sample loading process again 3 Emergency Stop Remove the Tower Cover to break the safety interlock sensor connection Emergency stops cause the Aspiration Needle to retract if already in the tube and the Mixer to return the tube s to the rack before bringing the Sample Loader to a halt To completely remove the cover lift it vertic...

Page 583: ...e Loader has been initialized and is in the READY state the message READY is displayed in the Status Box 3 When the START LOADER key in the RUN screen is pressed the Sample Loader pushes the rack s on the load side closest to the Analyzer a As the rack advances the sensor at Mixing Station 1 searches for a tube b Even if there are no tubes present in the rack the Transport Mechanism continues to m...

Page 584: ...t engaged as the rack advances The Mixing Assembly and Tower Assembly will not be engaged until a tube is sensed at either Mixing Station NOTE The Instrument operates most efficiently when tubes in a rack are adjacent to one another Generally spacing between sample tubes will have an impact on overall throughput If there are numerous empty spaces then throughput time may be significantly slowed 8 ...

Page 585: ...the load side 5 When the tube is at the Vent Aspiration Station the Spinner positions the tube vertically in the rack spins the tube for bar code reading and holds the tube while it is vented and the sample aspirated Proper positioning is necessary for the tube stopper to be pierced in the center 6 The Tower Cover on the CELL DYN 3200SL model fits over the Mixing Station and Bar Code Reader on the...

Page 586: ...13 22 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Sample Loader Sample Loader Operation Section 13 NOTES ...

Page 587: ...cedures on the SL model should be performed as directed in Section 9 Service and Maintenance These procedures consist of cleaning the Tower Cover the Needle the Tube Grippers the tray and the tube racks If the Vent Aspiration Needle requires replacement refer to Section 9 Service and Maintenance Subsection Closed Sample Needle Replacement Troubleshooting If a Sample Loader fault error or other pro...

Page 588: ...13 24 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Sample Loader Routine Operating Procedures Section 13 NOTES ...

Page 589: ...eens and some will not A Reticulocyte Data Log and a Reticulocyte QC Log are available for samples and controls run within the Reticulocyte Package Descriptions of all Reticulocyte soft keys are included in this chapter The prepared specimen run with the Reticulocyte Package on the CELL DYN 3200 System will measure results as a reticulocyte percentage The reticulocyte absolute number is automatica...

Page 590: ...14 2 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Reticulocyte Package Overview Section 14 NOTES ...

Page 591: ...m is complete within approximately 15 minutes The stained sample is aspirated in the Open Mode After the stained sample is aspirated it is diluted approximately 50 fold with WBC Lyse Reagent Once diluted with WBC Lyse the RBCs sphere due to the influence of the nonionic detergent incorporated into the staining solution Sphering is necessary to eliminate optical orientational noise that would other...

Page 592: ...uide the operator quickly and easily through the menu levels and soft key functions used in the Reticulocyte Package A segment of this flowchart is included at the beginning of each submenu description to guide the operator through the levels and functions of each submenu and back again to the MAIN MENU The master menu flowchart can be used as a pull out guide MAIN MENU Ready SET UP RUN DATA LOG Q...

Page 593: ...ATA DATA LOG BACK GROUND RETIC MAIN FIND SPECIMEN TRANSMIT DATA PRINT DATA LOG SPECIMEN RETIC VIEW QC LOG QC FILE SET UP RETIC MAIN QC LIMITS REAGENT RESERVOIR ENABLE ANALYZER DATE TIME RETIC PT LIMITS REAGENT LOG RETIC QC SET UP OPERATION SET UP UNITS SELECTION CUSTOMIZE REPORT RETIC MAIN SAME KEYS AS IN HEMATOLOGY RETIC QC QC FILE SET UP RETURN LIMITS RANGE MEANS LIMITS UPDATE LOAD FROM FILE ENT...

Page 594: ...14 6 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Reticulocyte Package Principles of Operation Section 14 NOTES ...

Page 595: ...ctions Turning the Reticulocyte Package ON and OFF RETIC MAIN Menu RETIC SET UP Menu RETIC DATA LOG Menu RETIC QC LOG Menu RETIC DIAGNOSTICS Menu RETIC SPECIAL PROTOCOLS Menu For information about the RETIC RUN menu refer to Routine Operation Retic Run Menu later in this chapter For specific instructions about running Reticulocyte specimens refer to Routine Operation Reticulocyte Specimens later i...

Page 596: ...n see Figure 14 1 which is accessed from the SET UP screen The Reticulocyte Package software is enabled when the TURN ON RETIC PKG key is pressed When the Reticulocyte Package is ON the soft keys are displayed as described in this chapter Figure 14 1 Operation Set Up Menu Screen with Reticulocyte Package Disabled TURN ON RETIC PKG OPERATION SET UP MENU Ready Feb 23 2001 Operator ID Sequence 18 18 ...

Page 597: ...T UP MENU screen press the TURN ON RETIC PKG key to enable the Reticulocyte Package 3 The RETIC MAIN menu screen displays The software to analyze reticulocytes is now enabled on the CELL DYN 3200 System MAIN MENU DATE UNITS SELECTION CUSTOMIZE REPORT PATIENT LIMITS SET UP OPERATION MAIN REAGENT LOG QC SET UP MENU SET UP DIAGNOSTICS SPECIAL PROTOCOLS RUN CALIBRA DATA LOG QUALITY TURN ON RETIC PKG L...

Page 598: ...cribed in Chapter 5 Operating Instructions Figure 14 2 Operation Set Up Menu Screen with Reticulocyte Package Enabled When the Reticulocyte Package is turned OFF the instrument automatically runs a wash cycle before returning to the Standard Hematology Mode CAUTION If the instrument has been idle for four hours it enters the STANDBY state and automatically returns to the Standard Hematology mode w...

Page 599: ... to disable the Reticulocyte Package The instrument automatically rinses runs a background and returns to the Standard Hematology Software 3 The MAIN MENU displays The software to analyze reticulocytes is now disabled on the CELL DYN 3200 System CD3200 RETIC MAIN MENU SELECTION REAGENT LOG SET UP OPERATION REPORT RETIC QC SET UP SET UP DIAGNOSTIC RETIC SP PROTOCOLS RUN DATA LOG TURN OFF RETIC PKG ...

Page 600: ...the top center of the screen This box appears on every screen to show the following information Menu in use such as RETIC MAIN Analyzer status such as Ready Other applicable information such as report or file identity and any existing fault conditions The cursor is positioned at the OPERATOR ID field when the RETIC MAIN menu screen is displayed An operator ID of up to three alphanumeric characters...

Page 601: ...ction 14 Reticulocyte Package The following soft key labels are displayed on the RETIC MAIN menu screen RETIC SET UP RETIC RUN RETIC DATA LOG DATA LOG RETIC QC RETIC DIAGNOSTIC RETIC SP PROTOCOLS The RETIC RUN menu is described in Routine Operation later in this chapter ...

Page 602: ...GY RETIC QC QC FILE SET UP RETURN LIMITS MEANS LIMITS UPDATE LOAD FROM FILE LIMIT SET 1 LIMIT SET 2 LIMIT SET 3 LIMIT SET 4 LIMIT SET 5 LIMIT SET 6 PRINT RETURN DELETE ENTRY DIL SHEATH LOG HGB LYSE LOG WBC LYSE LOG PRINT LOG RETURN TURN OFF RETIC PKG LANGUAGE SELECT COLOR BAR CODE SET UP COMPUTER SET UP RETURN PRINT RETURN FROM DISK LOT TOGGLE ON OFF PRINT NUMBER RETURN REPLICATE ID RANGE ENTRY DA...

Page 603: ...hey appear from left to right on the screen NOTE The DATE TIME REAGENT LOG and CUSTOMIZE REPORT are described in Section 5 Operating Instructions Subsection Set Up Instructions Retic Patient Limits The RETIC PT LIMITS key is used to display the RETIC PATIENT LIMITS screen see Figure 14 5 The following soft key labels are displayed on the RETIC PATIENT LIMITS screen LIMIT SET 1 LIMIT SET 2 LIMIT SE...

Page 604: ...be displayed and printed Procedure Enter Retic Patient Limits 1 From the RETIC SET UP screen press the RETIC PT LIMITS key to display the RETIC PATIENT LIMITS screen A patient limit set is displayed on the screen The other five limit sets Limit Set 2 Limit Set 3 etc may be displayed by pressing the appropriate soft keys 2 Use the arrow keys on the keyboard to move the cursor to the desired limit e...

Page 605: ...iculocyte QC files The keys are discussed in the order in which they are used to set up the QC files Use the arrow keys on the keyboard to move the cursor to the desired QC file shown on the RETIC QC LOG screen then type in the desired alphanumeric file name Up to 12 characters may be entered Press the Enter key on the keyboard to save the entry and advance the cursor to the next QC file Use the a...

Page 606: ...tween these two selections UPDATE FROM FILE This key displays when the file contains two or more results LOAD FROM DISK The feature enabling the upload of data from a floppy disk to a QC file is not available at this time PRINT RETURN Figure 14 7 Retic QC Range Entry Screen NOTE The UPDATE FROM FILE key displays when the file contains two or more results MEANS LIMITS RETIC QC RANGE Ready Feb 23 20...

Page 607: ...numbers Means and Limits This option is used to enter the mean value and a range value that defines the upper and lower flagging limits If Range Entry is selected by pressing the RANGE ENTRY key the current upper and lower limits for the selected file are displayed as shown in Figure 14 7 Retic QC Range Entry Screen If Means Limits Entry is selected by pressing the MEANS LIMITS key the current mea...

Page 608: ...PER LOWER Procedure Means Limits Entry 1 Select a file from the RETIC QC LOG screen by using the arrow keys on the keyboard to move the cursor to the desired file 2 Press the RETIC QC LIMITS key and if necessary press the MEANS LIMITS key to display the RETIC QC MEANS LIMITS entry screen for the selected file 3 Use the arrow keys on the keyboard to move the cursor to the desired entry field 4 Type...

Page 609: ...ve the entry 5 The cursor will advance to the WESTGARD RULE SELECTION entry fields Use the arrow keys on the keyboard to position the cursor at the desired Westgard Rule Press the TOGGLE ON OFF key to enable or disable the rule and advance the cursor 6 Repeat step 5 until all desired rule selections have been made 7 If desired press the PRINT key to obtain a printout of the entries 8 Press the RET...

Page 610: ...ticulocyte Package displays the following soft keys TURN OFF RETIC PKG LANGUAGE SELECT COLOR BAR CODE SET UP COMPUTER SET UP RETURN The TURN OFF RETIC PKG key is discussed earlier in this chapter in Retic Menu Options Turning the Reticulocyte Package ON and OFF The LANGUAGE SELECT COLOR BAR CODE SET UP and COMPUTER SET UP keys are described in Section 5 Operating Instructions Subsection Set Up Ins...

Page 611: ...t of units may be selected by pressing the appropriate soft key The following soft key labels are displayed on the UNITS SELECTION screen USA UNITS SI UNITS SI MOD UNITS SET1 UNITS SET2 UNITS SELECT UNITS RETURN USA UNITS UNITS SELECTION Ready Feb 23 2001 Operator ID Req Seq 19 05 R0001 ACS SI SI MOD UNITS SET1 UNITS SET2 UNITS RETURN UNITS SELECT UNITS Parameters WBC RBC HGB HCT RDW PLT PCT RETIC...

Page 612: ...ction The chosen selection is highlighted on the display 4 Use the arrow keys on the keyboard to move the cursor to the next unit to be selected 5 Repeat steps 3 and 4 until all selections have been made 6 If desired press the Print Screen key on the keyboard to obtain a printout of the selected units 7 Press the RETURN key to return to the RETIC SET UP menu Retic Run Menu For a description of the...

Page 613: ...st then it discusses how to review data from the Reticulocyte Data Log The current date time and operator ID and the last Reticulocyte Sequence Number that was used are displayed in the upper right hand corner of the RETIC DATA LOG screen Figure 14 12 Reticulocyte Data Log Screen NOTE Use the Left and Right Arrow keys to scroll through the list of parameters for all specimens displayed on a page U...

Page 614: ... ID BACKGROUND PG041 1 PG041 2 A61610 A61610 A61611 A61611 A61612 A61612 A61613 A61613 BACKGROUND D17516 D17516 Seq Specimen ID Date Time Op Date Time Op 1 34 5 84 4 08 4 30 3 92 3 61 9 15 8 49 8 70 9 57 1 63 1 54 2 70 2 70 4 16 4 16 3 51 3 51 2 60 2 60 4 68 4 68 110 116 163 150 321 298 226 249 76 72 0 5 RTC RBC RABS RTC RBC RABS COUNT COUNT O04 16 01 09 17 TS K04 17 01 06 26 TS K04 17 01 06 27 TS...

Page 615: ...only when the cursor is positioned next to a patient record DISPLAY SPECIMEN FIND SPECIMEN TRANSMIT DATA PRINT DATA LOG RETIC MAIN Edit ID The EDIT ID key on the RETIC DATA LOG screen is used to edit only the Specimen ID When the EDIT ID key is pressed the cursor moves into the SPECIMEN ID field and all soft key labels are blank Each edit is saved by pressing the Enter key on the keyboard NOTE The...

Page 616: ...EXT SPECIMEN This key label is not displayed when the last specimen in the RETIC DATA LOG is on the screen EDIT SPECIMEN TRANSMIT SPECIMEN PRINT REPORT or COLOR PRINT This key alternates between these two selections depending on whether the Color print option is turned ON RETURN PREVIOUS SPECIMEN RETIC DISPLAY SPECIMEN Priming Mar 24 2001 Operator ID Sequence 14 17 0201 gh NEXT EDIT SPECIMEN TRANS...

Page 617: ...t and display the results with a Parameter Set or Patient Limit Set different from the one currently displayed The following soft key labels are displayed when the EDIT SPECIMEN key is pressed CONFIRM CANCEL These keys are used to CONFIRM or CANCEL the edits The bulletin line displays the message PRESS CONFIRM TO SAVE CHANGES OR CANCEL TO CANCEL CHANGES When the CONFIRM key is pressed the edited r...

Page 618: ... displayed by pressing the DISPLAY SPECIMEN key If the record is not found in the Reticulocyte Data Log the bulletin line displays the message NO ENTRY FOUND NOTE If the patient name is used the name must be typed exactly as it was originally entered Transmit Data When the TRANSMIT DATA key is pressed the screen prompts the operator to enter the starting and ending Reticulocyte Sequence Numbers fr...

Page 619: ...IC DATA LOG Ready Aug 03 2001 Operator ID Retic Seq 16 53 R0484 TS Seq R Spec ID Name Patient Name F 1 1 1 1 1 1 1 1 1 1 1 1 1234 R471 R472 R473 R474 R475 R476 R477 R478 R479 R480 R481 R482 R483 R484 Seq Specimen ID PG041 2 A61610 A61610 A61611 A61611 A61612 A61612 A61613 A61613 BACKGROUND D17516 D17516 D17484 Seq Specimen ID Date Time Op Patient Name Patient ID Sex Limits Patient Name Patient ID ...

Page 620: ...cyte Data Log A record is displayed by positioning the cursor at the record you desire in the Reticulocyte Data Log listing and pressing the DISPLAY SPECIMEN key The Status Box indicates RETIC DISPLAY SPECIMEN on results displayed or printed from the Reticulocyte Data Log record See Figure 14 17 Figure 14 17 Reticulocyte Display Specimen Screen PREVIOUS SPECIMEN RETIC DISPLAY SPECIMEN Ready Aug 02...

Page 621: ...ey on the keyboard to exit from the search function and return to the RETIC DATA LOG screen 4 If the requested record is available the screen displays the page of the Reticulocyte Data Log with the cursor flashing at the Reticulocyte Sequence Number of the record 5 Press the DISPLAY SPECIMEN key to display the RETIC DISPLAY SPECIMEN screen for the selected record 6 Press the PRINT REPORT key or th...

Page 622: ...nings chart Westgard Rules can be applied to each QC Log The rule options can be used independently or in combination at the operator s discretion NOTE The RETIC QC LIMITS key and the QC FILE SET UP key are used to set up the QC files The following soft keys are displayed on the RETIC QC LOG screen VIEW QC LOG Move the cursor with the arrow keys on the keyboard to the QC file desired then press th...

Page 623: ...lays the file information and the data The Upper and Lower Limits and Target Mean entered are displayed immediately above each parameter name The Reticulocyte Sequence Number for each result is displayed to the left of the data The date time and operator ID when the reticulocyte sample was run are displayed to the right of the data 4 The following QC Log codes are displayed in the column immediate...

Page 624: ...ECT SPECIMEN or ACCEPT SPECIMEN This key label alternates between these two selections when the soft key is pressed DELETE SPECIMEN MOVE SPECIMEN PRINT QC LOG RETURN These soft keys are discussed in the order in which they appear on the screen from left to right Purge QC Log Soft Key The PURGE QC LOG key is used to delete the contents of a designated file in the QC Log When the PURGE QC LOG key is...

Page 625: ...VIOUS 10 and NEXT 10 keys can be used to scroll through the graphs The following soft key labels are displayed when the LEVEY JENNINGS key is pressed PREVIOUS 10 This key is not displayed when the first 10 data points are displayed NEXT 10 This key is not displayed when the last 10 data points are displayed PRINT RETURN The PRINT key is used to print the Levey Jennings graphs The RETURN key is use...

Page 626: ...PECIMEN key is used to delete the results for the specimen indicated by the cursor position When the DELETE SPECIMEN key is pressed the following soft key labels are displayed CONFIRM DELETION CANCEL DELETION These soft keys are used to confirm or cancel the Delete Specimen command When the CONFIRM DELETION key is pressed the results are deleted from the file the data are no longer displayed nor s...

Page 627: ...at is to be moved 4 Press the MOVE SPECIMEN key to display the VIEW RETIC QC LOG menu 5 Use the arrow keys on the keyboard to move the cursor to the file in which the results are to be placed 6 Press the MOVE TO FILE key to move the results to the designated file NOTE The results are moved to the end of the list of data that is currently in the file The placement of results in the list of data wil...

Page 628: ...shooting and in identifying the corrective action needed The DIAGNOSTICS MENU screen displays a subset of the soft keys displayed on the main DIAGNOSTICS menu The following soft keys are displayed on the DIAGNOSTICS MENU screen FAULTS REPORT EXECUTION TIMES RETIC CNT RATE CLEAR FAULTS RETIC RAW DATA RETIC MAIN These soft keys are discussed in the order in which they appear on the screen from left ...

Page 629: ...play the time in tics used for various cycles during routine function of the system NOTE A tic is an integer that equals 0 055 seconds Retic Count Rate Figure 14 23 Reticulocyte Count Rate Screen Tabular Format When the RETIC CNT RATE key is pressed followed by RETIC CNT DATA the following soft key labels are displayed RETIC CNT GRAPH PRINT RETURN RETIC CNT GRAPH DIAGNOSTICS MENU Ready Aug 02 2001...

Page 630: ...shooting problems with the reticulocyte parameter A printout of the Reticulocyte Count Rate may be obtained by pressing the PRINT key when the desired format is displayed on the screen Figure 14 24 Reticulocyte Count Rate Screen Graphic Format Clear Faults When the CLEAR FAULTS key is pressed the Analyzer returns to the READY state if the corrective action that was taken has resolved the problem I...

Page 631: ...e time the key is pressed If no data are displayed on the screen the printed report contains the current fault status Retic Main The RETIC MAIN key is used to return to the RETIC MAIN menu screen The RETIC MAIN key appears on most primary RETIC DIAGNOSTICS screen and works the same way on each screen FAULTS REPORT DIAGNOSTICS MENU Ready Feb 23 2001 Operator ID Retic Seq 19 24 R0002 ACS EXECUTION R...

Page 632: ...ANALYZER RETIC MAIN A brief description of the function of each soft key follows Instructions for the detailed use of each function are given in the appropriate maintenance procedure in Section 9 Service and Maintenance Figure 14 26 Reticulocyte Special Protocols Screen SPECIAL PROTOCOLS RETIC DISAB ENAB ANALYZER CLEAN RES SHEAR VALVE MAIN EMPTY FILL FLOW CELL CD3200 RETIC MAIN MENU REAGENT RESERV...

Page 633: ... WBC lyse supply tubing is refilled Empty Fill Flow Cell NOTE This procedure is performed only in the Open Mode If necessary press CHANGE SAMPLER in the RUN screen to select Open Mode Pressing the EMPTY FILL FLOW CELL key displays a submenu showing the EMPTY FLOW CELL and RETURN keys When the EMPTY FLOW CELL key is pressed diluent sheath in the Optical Flow Cell is drained and the key toggles to F...

Page 634: ...howing the DISABLE ANALYZER and RETURN keys The DISABLE ANALYZER key is used to prevent the Analyzer from cycling while certain maintenance procedures are performed After the Analyzer had been disabled the key toggles to ENABLE ANALYZER When the ENABLE ANALYZER key is pressed the Analyzer is returned to the state prior to disabling Retic Main The RETIC MAIN key is used to return to the RETIC MAIN ...

Page 635: ...Package for the CELL DYN 3200 System This section contains the following subsections Retic Specimen Type Flowchart RETIC SPECIMEN TYPE Menu Reticulocyte Specimens Specimen Requirements Interfering Substances Running Background Counts Quality Control Specimen Preparation Specimen Analysis For instructions on turning the Reticulocyte Package ON and OFF refer to Retic Menu Options Turning Reticulocyt...

Page 636: ...14 Retic Specimen Type Flowchart RETIC PATIENT SPECIMEN RETIC SPECIMEN TYPE RETIC PATIENT SPECIMEN MAIN QC SPECIMEN BACK GROUND RETIC RUN RESULT RETIC RUN RESULT RETIC RUN RESULT ENTER SPECIMEN ID DATA CD3200 RETIC MAIN MENU RETIC SP RETIC RUN PROTOCOLS RETIC DATA LOG DATALOG RETIC SET UP RETIC DIAGNOSTIC RETIC QC ...

Page 637: ... the RETIC SPECIMEN TYPE screen CLEAR FAULT This key appears only if a system fault occurs PATIENT SPECIMEN QC SPECIMEN BACKGROUND RETIC MAIN These soft keys will be discussed as they appear on the RETIC SPECIMEN TYPE screen from left to right Clear Fault The CLEAR FAULT key is displayed on the RETIC SPECIMEN TYPE screen whenever a system fault occurs for example Diluent Empty This key is used aft...

Page 638: ...nt name is used for the specimen ID the name must be typed exactly as it was originally entered in the Standard Hematology Data Log NOTE Specimen IDs must match exactly and are case sensitive Figure 14 28 The First Reticulocyte Patient Specimen Screen If the specimen ID is found the second RETIC PATIENT SPECIMEN screen is displayed See the following figure This screen displays the patient demograp...

Page 639: ...c information or the RBC value If an entry error is made in the second RETIC PATIENT SPECIMEN screen the operator may press the CANCEL key to return to the RETIC SPECIMEN TYPE screen Figure 14 29 The Second Reticulocyte Patient Specimen Screen Displayed When the Specimen ID is Found If the ID located is from a specimen run more than 8 hours ago the third RETIC PATIENT SPECIMEN screen is displayed ...

Page 640: ...re Than Eight Hours Old RETIC SPECIMEN TYPE Ready Aug 03 2001 Operator ID Retic Seq 16 29 R0484 TS CANCEL ENTER SPECIMEN ID d17484 Press ENTER to confirm SPECIMEN ID D17484 was found in HEMATOLOGY DATA LOG but specimen data are more than 8 hours old Enter RBC value M uL Press ENTER to confirm Press ENTER to continue if no Hematology Specimen result is available If no RBC value is entered only RETI...

Page 641: ...r may press the CANCEL key to return to the RETIC SPECIMEN TYPE screen If the operator presses the Enter key to confirm the RBC value the RETIC RUN RESULT screen is displayed Figure 14 31 The Fourth Reticulocyte Patient Specimen Screen Displayed When the Specimen ID Is Not Found RETIC SPECIMEN TYPE Ready Aug 03 2001 Operator ID Retic Seq 16 35 R0484 TS CANCEL SPECIMEN ID 111 SPECIMEN ID 111 was fo...

Page 642: ...atology Data Log when the patient specimen ID was entered into the first RETIC PATIENT SPECIMEN screen If the information was not found in the Standard Hematology Data Log the patient name can be entered here up to 16 characters NOTE If an entry error is made in the second RETIC PATIENT SPECIMEN screen the operator may press the CANCEL key to return to the RETIC SPECIMEN TYPE screen 3 Pat ID This ...

Page 643: ... enter the comments Up to 16 characters may be entered 9 Limits This data entry field automatically displays the number of the Limit Set that will be applied to the sample results NOTE The Limit Set applied to the reticulocyte sample may be changed after the specimen has been run Refer to the description for the EDIT SPECIMEN key given in Reticulocyte Menu Options Reticulocyte Data Log Menu Displa...

Page 644: ... RBC value entry is also displayed on the left side The scatterplots and the histograms are displayed on the right The red blood cells are shown in red the reticulocytes are shown in blue the nucleated cells are shown in white black on the color printout the immature Reticulocytes are shown in cyan light blue and coincidence passage events are shown in green and the noise is shown in yellow Any al...

Page 645: ...TIC SPECIMEN TYPE screen is pressed the QC file where the cursor is positioned is opened and the RETIC RUN RESULT screen for QC specimens is displayed See the preceding figure Results from the QC run option are stored in the selected reticulocyte QC file and in the Reticulocyte Data Log RETIC RUN RESULT Ready Feb 23 2001 Operator ID Retic Seq 19 58 R0003 ACS CANCEL Lot Number 65185 File SCORTE 0 1...

Page 646: ...TIC RUN RESULT screen for background counts is displayed See the preceding figure Results from this run option are identified by the designation BACKGROUND on the RETIC RUN RESULT screen and in the Retic Data Log Retic Main When the RETIC MAIN key is pressed the RETIC MAIN menu screen is displayed RETIC RUN RESULT Ready Feb 23 2001 Operator ID Retic Seq 19 58 R0003 ACS CANCEL Type BACKGROUND Backg...

Page 647: ... s displayed for that specimen type When the reticulocyte sample is completed the NEXT RETIC key is displayed When the NEXT RETIC key is pressed the operator can then select the specimen type for the next specimen Specific instructions for each specimen type are given later in this section CAUTION When using the reticulocyte reagent avoid contact with skin and clothing This reagent contains New Me...

Page 648: ...ng substances are present in sufficient numbers they may interfere with the dynamic thresholds used to obtain the CELL DYN 3200 reticulocyte count Consequently these specimens should be flagged by the instrument Refer to Troubleshooting Instrument Alert Conditions within this chapter for a complete description of the Reticulocyte flags The information in the following table based on NCCLS Document...

Page 649: ...nalyzer Status Indicator Panel The Status Box on the RETIC RUN RESULT screen will display messages indicating the various stages of the cycle 8 Remove the tube when the beep sounds The Wash Block will move down the probe and clean it 9 When the cycle is complete the Wash Block moves back to the top of the probe and the Ready message is displayed in the Status Box 10 The screen displays the backgro...

Page 650: ...the QC SPECIMEN key The RETIC RUN RESULT screen for QC specimens is displayed The control file information is located in the upper left hand corner of the screen 9 Open the well mixed prepared control specimen tube and immerse the Open Sample Aspiration Probe in the sample 10 Press the Touch Plate located behind the probe to start the cycle The BUSY indicator light on the Analyzer Status Indicator...

Page 651: ... the whole blood specimen into each labeled tube of reticulocyte reagent 6 Incubate the stained Reticulocyte specimens on the rotator or in a rack after fully inverting the stained specimens 5 times Incubation must be performed according to the reagent package insert NOTE The stained Reticulocyte specimens must incubate for 15 minutes but no more than 2 hours prior to processing on the CELL DYN 32...

Page 652: ...he Reticulocyte Data Log after the reticulocyte run is complete 7 The prepared dilution s of the patient reticulocyte sample s can be run after the control and background count results have met the laboratory s criteria 8 Open the well mixed prepared patient reticulocyte sample tube and immerse the Open Sample Aspiration Probe in the sample 9 Press the Touch Plate located behind the probe to start...

Page 653: ...ontrol material for performing quality control checks on the CELL DYN 3200 System These controls should be run After daily start up procedures are completed After a reagent lot number change After a service call or component replacement After calibrating the Standard Hematology Mode In accordance with the laboratory s quality control protocol According to regulatory requirements NOTE Data invalida...

Page 654: ...in a suitable location in the refrigerator away from the door if it is opened frequently Carefully warm the CELL DYN Retic RITE controls prior to mixing according to the directions given in the package insert Proper mixing is essential for accurate results Mix the CELL DYN Retic RITE control vials gently by hand to thoroughly resuspend the control material Do not use automatic mixers to resuspend ...

Page 655: ...roubleshooting Operational Messages and Data Flagging Dispersional Data Alerts Instrument Alert Messages Alert Messages with Suppressed Reticulocyte Results Data Invalidating Alerts High Background Counts NOTE For a list of interfering substances refer to Routine Operation Reticulocyte Specimens Interfering Substances within this chapter General Guidelines for Reticulocyte Troubleshooting Reticulo...

Page 656: ...t Messages with Suppressed Reticulocyte Results Suppression of Reticulocyte results occurs when the sample run data acquisition process exceeds normal parameters When the Reticulocyte results are suppressed one of the following three alerts will be displayed in the lower left hand quadrant of the Display Monitor screen in the Reticulocyte Package and on the graphics printout under the heading ALER...

Page 657: ...ound Counts Table 14 3 Data Invalidating Alerts Alert Probable Cause Corrective Action Fragile RBCs NOTE Alert occurs when the average count rate rapidly decreases during the Reticulocyte count cycle Air bubble Staining a fragile RBC specimen too long in the reticulocyte reagent Fragile RBCs 1 Run a background count to cycle air through the system Rerun the Reticulocyte specimen 2 Prepare another ...

Page 658: ...roved Guideline NCCLS document EP9 A ISBN 1 56238 283 7 NCCLS 940 West Valley Road Suite 1400 Wayne PA 19087 1898 1995 3 National Committee for Clinical Laboratory Standards Evaluation of the Linearity of Quantitative Analytical Methods Proposed Guideline NCCLS document EP6 P ISBN 1 56238 019 2 940 West Valley Road Suite 1400 Wayne PA 19087 1898 1986 4 International Committee for Standardization i...

Page 659: ...System incorporates an integral bar code reader allowing the use of bar codes on both the SL and CS models The bar code labels contain the specimen identification codes CAUTION Ensure that specimen has been properly identified before placing bar code label on specimen tube Bar Code Function The bar code label contains the actual identifying data for specimens in the form of a series of black bars ...

Page 660: ... bar code symbol This zone enables the scanner to read the code properly Start and Stop Characters indicate the beginning and end of the bar code symbol They allow the label to be scanned from either right to left or left to right ensuring that code information is transmitted correctly Intercharacter Gaps act as spaces between each character in the bar code symbol Code 39 contains these gaps Howev...

Page 661: ...ave one of three different meanings depending on which of three different character sets is used Three different start characters tell the reader which of the character sets is initially being used and three shift codes permit changing the character set inside a symbol Interleaved 2 of 5 Interleaved 2 of 5 encodes the 10 numeric digits 0 9 The name is derived from the method used to encode two cha...

Page 662: ...A 4 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Bar Codes Overview Appendix A NOTES ...

Page 663: ... Digits are used whenever the instrument is to read a specific type of bar code To enable or disable the check digit option refer to Section 5 Operating Instructions Subsection Bar Code Set Up Check Digit specifications are as follows Code 39 The modulus 43 sum of all the character values in a given message Code 128 The check digit is built into the Bar Code Reader Interleaved 2 of 5 The check dig...

Page 664: ...ory generated bar code labels are unavailable Bar Code Label Placement CAUTION Ensure that specimen has been properly identified before placing bar code labels on specimen tubes The following two guidelines should be observed when placing bar code labels on specimen tubes refer to Figure A 1 1 All labels should be placed on the tubes securely and without flaps sticking out Refer to the following f...

Page 665: ...CELL DYN 3200 System Operator s Manual A 7 9140181H October 2001 Appendix A Bar Codes Figure A 1 Bar Code Placement Guide ...

Page 666: ...A 8 CELL DYN 3200 System Operator s Manual 9140181H October 2001 Bar Codes Specifications Appendix A NOTES ...

Page 667: ...d in the Demographics section of the RUN screen When the result is available it is saved in the Data Log and the entry is deleted from the Work List If no matching entry is found the specimen is identified in the Data Log by the tube bar code number in the Specimen ID field If the check digits do not match the read is not good and the Work List is not searched For SL models the Rack and Tube is as...

Page 668: ... digit The specimen is identified in the Data Log by the tube bar code number in the Specimen ID field b read all four bar code symbologies labels without a check digit The read is assumed to be good without a check digit the bar code number cannot be verified and the Work List is searched for a matching bar code number in the Specimen ID field If a matching entry is found in the Work List the ent...

Page 669: ...n is identified in the Data Log by the Rack and Tube number assigned to the Specimen ID field by the Instrument For CS models the specimen is identified in the Data Log by the Sequence number only and the Specimen ID field is left blank If the Instrument is configured for I2of5 with Check Digit OFF the Instrument will a read all four bar code symbologies labels with a check digit The bar code read...

Page 670: ...the specimen is identified in the Data Log by the Rack and Tube number assigned to the Specimen ID field by the Instrument For CS models the specimen is identified in the Data Log by the Sequence number only and the Specimen ID field is left blank If the Instrument is configured for Codabar with Check Digit OFF the Instrument will a read all four bar code symbologies labels with a check digit The ...

Page 671: ...o matching entry is found the specimen is identified in the Data Log by the tube bar code number in the Specimen ID field If the check digits do not match the read is not good and a Check Digit Error message is displayed on the Bulletin line The Work List is not searched For SL models the Rack and Tube is assigned to the Specimen ID field for that specimen in the Data Log For CS models only the Se...

Page 672: ...ual 9140181H October 2001 Bar Codes Acknowledgment Appendix A Acknowledgment The authors wish to acknowledge Computype Inc of St Paul Minnesota for providing their booklet Bar Coding and Productivity to assist in the writing of this Appendix ...

Page 673: ...Station For communication between Data Station and Analyzer computer 20005 01 1 Cable Interface printer 6 For communication between Printer and Data Station computer 8240051601 2 Cable Power 6 7 For Analyzer 5100165 2 Fuse 8 amp T Slo Blo Analyzer 110 VAC 8510016401 2 Fuse 4 amp T Slo Blo Analyzer 220 VAC 06H65 01 1 kit Reagent Line Kit See Reagent Inlet Waste Outlet Tubing Kit for individual tubi...

Page 674: ...idge For use with Canon Bubble Jet 4300 Printer 06H87 04 1 Color Ink cartridge For use with Canon Bubble Jet 4300 Printer 06H74 01 1 Keyboard CELL DYN 3200 English NMB 120439 001 supplied by factory 06H75 01 1 Keyboard Protective cover For use with NMB keyboard 120439 001 01J52 01 1 Printer Cartridge Color For use with Epson 888 printer 01J53 01 1 Printer Cartridge Black For use with Epson 888 pri...

Page 675: ... 960mL blttle 07H67 02 5 Cap large Reagent line tubing For the 3 8 and 20L containers 99644 01 1 Enzymatic Cleaner 99660 01 125 pkg DYN A WIPE 98661 01 40 boxes case DYN A WIPE 99624 01 Pre Printed Tickets Table B 4 CELL DYN 3200 Controls Calibrator List Number Quantity Name Description 01H61 01 1 Calibrator CELL DYN HemCal 3 0 mL tube with pierceable cap insert and assay sheets 01H71 01 1 Control...

Page 676: ...t CN free HGB NOC Lyse 3 8 L cubitainer 4 03 01 kg 1 case 03H40 01 1 Reagent Reticulocyte 5 0 mL tubes each tube containing 3 7 mL of reagent Kit of 100 Table B 6 CELL DYN 3200 Reagent Inlet Outlet Tubing List Number 06H65 01 List Number Quantity Name Comments 8921205901 1 Tubing Reagent Diluent Sheath Includesreagentcontainercap and sinker 8921211501 1 Tubing Reagent HGB NOC Lyse Includesreagentc...

Page 677: ...6 21 6 26 6 29 Auto Calibrate screen 6 17 Auto Clean 9 7 Auto Clean cycle 5 99 Auto Clean Open Mode 9 13 Automatic Shutdown 5 99 B Background 4 9 Background Counts 1 26 4 9 5 74 6 10 9 14 9 15 9 16 9 24 9 33 9 35 9 38 9 45 9 47 9 49 9 52 9 54 10 26 Background Counts troubleshooting 10 25 Background Soft Key 14 58 Bar Code 5 59 5 91 5 115 5 118 13 1 Bar Code Format 4 6 Bar Code Label 13 6 13 7 Bar ...

Page 678: ...pport Center 10 24 CV 14 36 D Daily Shutdown 9 7 Daily Shutdown cycle 5 99 Daily Shutdown Procedure 5 99 Data Flagging 14 68 Data Invalidating Alerts 14 69 Data Log 5 65 5 72 5 73 5 74 5 103 5 109 5 115 5 120 5 125 5 127 5 130 5 132 5 134 5 135 10 26 Menu Flowchart 5 7 Data Log Customize Display 5 132 5 139 Data Log Customize Printout 5 135 5 141 Data Log Customize Report 5 128 Data Log Display Sp...

Page 679: ...ed 10 31 Fault Conditions Non functional 10 31 Fault Conditions Operator correctable 10 6 FAULT REPORT 14 41 Faults 1 9 5 66 5 67 5 69 10 1 10 15 Faults Clearing 5 69 5 97 Faults Conditions 1 9 5 67 5 69 5 97 10 1 10 31 Faults Tables 10 1 10 31 FILE MEAN 14 36 Flagging Messages 3 27 Flags 4 16 5 77 5 110 10 28 Flags Suspect Parameter 3 30 Floppy Disk Drive 1 15 1 20 Flow Cell Assembly 1 19 Flow Er...

Page 680: ... power switch 5 59 Maintenance nonscheduled 9 29 Maintenance Log 10 25 Maintenance Procedures daily 9 13 Maintenance Procedures monthly 9 21 Maintenance Procedures semiannual 9 27 Maintenance Procedures weekly 9 19 Maintenance Schedule 9 10 Manual Organization xiii MCH 1 2 11 23 MCH calculation 3 21 MCHC 1 3 11 23 MCHC calculation 3 21 MCV 11 23 MCV calculation 3 20 Means and Limits 14 19 MEANS LI...

Page 681: ...36 Power OFF Procedure 5 62 Power ON Procedure 5 59 Power Requirements 2 4 Power Specifications 4 4 Power Supply Module 1 17 Precautions and limitations 7 1 Preparation for shipping 9 7 9 56 Pre printed ticket 12 5 pressure pump test 10 12 Pressure Test 10 14 10 17 Preventive Maintenance 9 9 Printed Circuit Boards 1 21 Printer 5 59 Printer Cleaning 9 27 Printer connector 12 5 Printer Graphics 1 21...

Page 682: ...14 58 RETIC PATIENT LIMITS 14 15 RETIC PATIENT SPECIMEN 14 50 RETIC PATIENT SPECIMEN screen 14 50 14 51 14 53 RETIC PT LIMITS 14 15 Retic QC Limit 14 18 RETIC QC SET UP 14 17 Retic Run Menu 14 6 Retic Run Menu Flowchart 14 4 RETIC RUN RESULT screen 14 53 14 54 RETIC RUN screen 14 49 14 59 Reticulocyte Package 14 3 Reticulocyte QC files 14 17 Reticulocyte Reagent 14 65 Reticulocyte Reagent 1 27 14 ...

Page 683: ...ing 9 31 Shear Valve Cleaning procedure 9 4 9 5 9 13 Sheath Reservoir 1 12 3 10 Short Term Shutdown 5 100 Shutdown 5 59 shutdown period of inactivity 5 62 SIZE COMPLEXITY 10 27 Soft Key Text Convention xvi Soft Keys 1 22 Space Requirements 2 3 Special Protocols Flowchart 5 12 Specimen ID 14 50 Specimen Preparation 14 63 Specimen Requirements 14 59 Spinner Assembly 1 12 Standard Groups 5 134 Standb...

Page 684: ...m Accumulators 10 15 Vacuum Pump test 10 12 Vacuum Test 10 14 10 17 Vent Aspiration Needle 1 12 Voltage 1 18 Voltage Readings 10 17 W Warranty ii Wash Block 1 11 Waste 1 12 1 17 Waste Container 6 10 Waste Containers 1 17 Waste Outlet Tube 1 17 Waste Sensor 1 17 2 6 Waste Sensor Connector 1 17 WBC 1 2 1 26 5 77 5 134 WBC Analysis 3 4 WBC Differential 5 97 WBC Lyse 1 26 WBC Lyse Inlet Tube 1 17 WBC ...

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