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Abbott CELL-DYN 3000, Operator'S Manual

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CELL-DYN

 3000 System Operator’s Manual

7-21

9140240E — May 1995

Chapter 7

Quality Control

References

1.

Cembrowski GS, Carey RN. Laboratory quality management, p. 
189.

2.

Westgard JO et al. A multi-rule Shewhart chart for quality control 
in clinical chemistry. Clin Chem 1981; 27:3:493–501.

3.

Cembrowski GS, et al. Use of a multi-rule control chart for the 
quality control of PT and APTT analyses. Lab Med June 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, Hay KL. Are red blood cell indexes international? Arch 
Pathol Lab Med 1985; 109:604–606.

8.

Chanarin I, ed. Laboratory hematology, an account of laboratory 
techniques. Edinburgh: Churchill Livingstone, 1989:3–7.

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Book TOC

Summary of Contents for CELL-DYN 3000

Page 1: ... Installation Principles of Operation System Specifications Operating Instructions Calibration Quality Control Precautions Limitations and Hazards Maintenance Troubleshooting Printer Sample Loader Bar Codes ENTIRE CONTENTS COPYRIGHT ABBOTT LABORATORIES ABBOTT LABORATORIES 1993 ABBOTT PARK IL 60064 U S A PRINTED IN THE U S A CD TOC EXIT ...

Page 2: ...ponents 1 5 Analyzer Components 1 6 Front Panel 1 6 Flow Panel 1 8 Left Side Panel 1 12 Rear Panel 1 15 Data Station 1 17 Overview 1 17 Data Station Components 1 17 Front Panel 1 18 Right Side Panel 1 19 Rear Panel 1 20 Printer 1 22 Sample Loader 1 22 Reagent System 1 22 Introduction 1 22 CELL DYN Reagents 1 23 Chapter 2 Installation Introduction 2 1 Initial Preparation 2 2 Space Requirements 2 2 ...

Page 3: ...5 Overview 3 5 Introduction to Flow Cytometry 3 6 Sheath Reagent 3 8 Detection with the Optical Bench 3 8 WBC Differential 3 10 WBC Parameters 3 15 WBC Flagging 3 16 RBC PLT Measurement 3 17 Overview 3 17 Electrical Impedance Measurements 3 17 Coincidence Passage Correction 3 17 RER 3 18 Volumetric Metering 3 18 RBC PLT Measurement 3 19 RBC Parameters 3 20 PLT Measurement 3 22 Platelet Parameters ...

Page 4: ...put 4 4 Collection Tube and Sample Volume 4 4 Bar Code Specifications CELL DYN 3000SL 4 5 Bar Code Format 4 5 Bar Code Label Specifications 4 5 Physical Specifications CELL DYN 3000CS 4 6 Power Specifications CELL DYN 3000CS 4 7 Consumption 4 7 Operational Specifications CELL DYN 3000CS 4 8 Operating Environment 4 8 Complete Cycle Times 4 8 Approximate Aspiration Volumes whole blood 4 8 Measuremen...

Page 5: ...5 29 Procedure Bar Code Set Up 5 31 Procedure Computer Setup 5 34 Procedure Units Selection 5 36 Procedure Customize Display 5 38 Routine Operation 5 51 Introduction 5 51 Data Station Run Menu 5 52 Data Station Run Screen 5 53 Status Box 5 54 Bulletin Line 5 55 Flagging Diagnostics Screen 5 56 Data Station Run Screen Soft Keys 5 58 Procedure Resistant RBC 5 66 Sample Collection and Handling 5 67 A...

Page 6: ... Review from the Data Log 5 117 Scrolling Through the Data Log 5 117 Displaying a Record 5 117 Procedure Record Display 5 118 Editing a Record 5 119 Procedure Edit Specimen 5 119 References 5 121 Chapter 6 Calibration Introduction 6 1 Calibration Materials 6 2 General Information 6 3 Calibration Procedural Guidelines 6 3 Conventions Used in this Chapter 6 4 Calibration Procedural Summary 6 5 Whole...

Page 7: ...on Factor Calculation 6 36 Determining Which Parameters Need Calibration 6 37 Calibration for All Parameters 6 39 Calibration for Individual Parameters 6 40 Completing Open Mode Calibration 6 40 Auto Cal Using Whole Blood Samples 6 42 Procedure 6 42 Starting Auto Cal 6 42 Entering the Reference Values 6 42 Performing the Calibration 6 43 Calibration Factor Calculation 6 45 Determining Which Parame...

Page 8: ...e Values 6 71 Performing the Calibration 6 72 Calibration Factor Calculation 6 74 Determining Which Parameters Need Calibration 6 75 Calibration for All Parameters 6 77 Calibration for Individual Parameters 6 78 Completing Mode to Mode Calibration 6 78 Manual Mode To Mode Calibration 6 81 Procedure 6 81 Preparing for Manual Mode to Mode Calibration 6 81 Determining the Open Mode Mean 6 81 Determin...

Page 9: ... 7 21 Chapter 8 Precautions Limitations and Hazards Limitations 8 1 Location Requirements 8 1 Electrical Safety Precautions 8 2 Mechanical Safety Precautions 8 3 Chemical Safety Precautions 8 3 Infection Control 8 3 Decontamination Procedures 8 4 Blood Samples 8 4 Spills 8 4 Reagent Storage and Handling 8 5 Laser Precautions 8 5 Printer Precautions 8 5 Sample Loader Precautions 8 6 Chapter 9 Maint...

Page 10: ...globin Flow Cell Manual Cleaning Procedure 9 39 Vacuum Accumulator Cleaning Procedure 9 41 Special Procedures 9 43 Closed Sampler Tube Retainer Adjustment 9 43 Preparation for Inactivity or Shipping 9 44 Repackaging for Shipment 9 46 Chapter 10 Troubleshooting Introduction 10 1 Diagnostics Menu 10 3 Diagnostics 10 4 Troubleshooting Guide 10 25 Introduction to Troubleshooting 10 25 Obtaining Techni...

Page 11: ...ditions 10 45 Summary of Table 10 2 General Fault Conditions 10 53 Summary of Table 10 3 Sample Related Fault Conditions 10 67 Summary of Table 10 4 Non Functional Fault Conditions 10 73 Chapter 11 Printer Introduction 11 1 Printing Graphics Reports 11 1 Printing Tickets 11 1 Loading Individual Tickets 11 2 Maintenance 11 5 Troubleshooting 11 6 Chapter 12 Sample Loader Overview 12 1 Labels 12 2 CE...

Page 12: ...tion To Bar Codes A 1 Bar Coding Function A 1 Understanding the Label Code A 2 Bar Code Types and Characteristics A 2 CELL DYN 3000 Bar Code Specifications A 3 Bar Code Label Specifications A 3 CELL DYN Bar Code Labels A 4 CELL DYN Q Labels A 4 Bar Code Label Placement A 5 Acknowledgment A 6 Search Go Back Book TOC ...

Page 13: ...Master Table of Contents 12 CELL DYN 3000 System Operator s Manual 9140240E May 1995 NOTES Search Go Back Book TOC ...

Page 14: ...on Rear Panel 2 6 Figure 2 2 Analyzer with Sample Loader 2 8 Figure 2 3 Sample Loader Tubing Connections 2 9 Figure 2 4 Tube Rack Showing Label Placement Location 2 11 Figure 3 1 WBC Flow Cell 3 7 Figure 3 2 WBC Light Scatter 3 8 Figure 3 3 Optical Bench 3 9 Figure 3 4 Mononuclear Polymorphonuclear Scatter 3 11 Figure 3 5 Neutrophil Eosinophil Scatter 3 12 Figure 3 6 Mononuclear Scatter 3 13 Figur...

Page 15: ...re 5 22 Customize Printed Report Screen for Pre Printed Tickets 5 45 Figure 5 23 Customize Printed Report Screen for Blank Tickets 5 47 Figure 5 24 Run Screen for Patient Samples 5 52 Figure 5 25 Run Screen Showing Bulletin Line Message 5 55 Figure 5 26 Flagging Diagnostics Screen 5 56 Figure 5 27 Work List Screen 5 58 Figure 5 28 Specimen Type Screen 5 60 Figure 5 29 Run Screen for Patient Sample...

Page 16: ...ure 6 8 Whole Blood Auto Cal Results Screen 6 21 Figure 6 9 Whole Blood Auto Cal Results Screen 6 22 Figure 6 10 Calibrator Auto Cal Screen 6 23 Figure 7 1 QC Menu Screen 7 4 Figure 7 2 The X B Display Screen Data 7 5 Figure 7 3 The X B Display Screen Graph 7 6 Figure 7 4 The View QC Log Screen 7 7 Figure 7 5 The Levey Jennings Menu Screen 7 10 Figure 7 6 View QC Log Screen With Rejected Results 7...

Page 17: ...Data Summary Screen 10 11 Figure 10 9 Second Diagnostics Menu Screen 10 12 Figure 10 10 Pump Operation Screen 10 13 Figure 10 11 Pump Operation Screen Vacuum ON 10 14 Figure 10 12 Inhibit Pumps Screen 10 15 Figure 10 13 Vacuum Test Screen 10 16 Figure 10 14 Third Diagnostics Menu Screen 10 17 Figure 10 15 Voltage Readings Screen 10 18 Figure 10 16 Fourth Diagnostics Menu Screen 10 19 Figure 10 17 ...

Page 18: ...ts 17 9140240E May 1995 Figure 12 4 Sample Loader 12 4 Figure 12 5 Operation Keyboard 12 5 Figure 12 6 Tower Stations 12 8 Figure 12 7 Tube Racks 12 10 Figure A 1 Bar Code Label Specifications A 4 Figure A 2 Tube Labeling Requirements A 5 Search Go Back Book TOC ...

Page 19: ...Master Table of Contents 18 CELL DYN 3000 System Operator s Manual 9140240E May 1995 NOTES Search Go Back Book TOC ...

Page 20: ...fications 4 11 Table 4 10 Accuracy of Hemogram Parameters 4 12 Table 4 11 Accuracy of WBC Differential Parameters 4 12 Table 4 12 Carryover for WBC RBC HGB and PLT 4 13 Table 5 1 Report Units 5 36 Table 6 1 Calibration Criteria Chart 6 4 Table 6 2 Calibration Procedural Summary 6 5 Table 6 3 Calibration Criteria Chart 6 37 Table 6 4 Calibration Criteria Chart 6 46 Table 6 5 Calibration Criteria Ch...

Page 21: ...Master Table of Contents 20 CELL DYN 3000 System Operator s Manual 9140240E May 1995 NOTES Search Go Back Book TOC ...

Page 22: ...we also provide telephone technical assistance should you need additional information or assistance in diagnosing a problem This service is available by calling the Abbott Customer Support Center at 1 800 CELL DYN or 1 800 235 5396 Abbott Customer Support Specialists are available 7 days a week 24 hours a day If a problem cannot be resolved by telephone on site support is offered by Abbott s Field...

Page 23: ... All rights are reserved This software was developed solely for use with Abbott Laboratories equipment and for in vitro diagnostic applications as specified in the operating instructions This product contains software licensed from Microsoft Corporation All operating instructions must be followed In no event shall Abbott be responsible for failures errors or other liabilities resulting from a cust...

Page 24: ... reported to Abbott during the Warranty Period and within one week of occurrence 2 Result from chemical decomposition or corrosion 3 Are caused by customer or third party abuse misuse or negligence or by failure to comply with any requirement or instruction contained in the applicable Abbott Operator s Manual 4 Result from maintenance repair or modification performed without Abbott s authorization...

Page 25: ...cs a wholly owned subsidiary of Abbott Laboratories Abbott Park IL 60064 U S A Please direct all inquiries concerning information in this manual to the foregoing address NOTE Direct all inquiries regarding equipment problems to the Abbott Customer Support Center at 1 800 CELL DYN or 1 800 235 5396 U S customers only Search Go Back Book TOC ...

Page 26: ...eys are also depicted as follows INFORMATION PRESENTATION Note Important INDENTED ALL CAPITALS BOLD Screen or Menu display ALL CAPITALS UNIVERSAL BOLD Data entry field Within Brackets Universal Bold Text matches screen Bulletin Message Universal Bold Text matches screen Status Condition ALL CAPITALS UNIVERSAL Soft Keys UNIVERSAL BOLD ALL CAPITALS Brackets MAIN MENU SUB MENU Search Go Back Book TOC...

Page 27: ...n caution and danger It denotes a clear and present danger CAUTION Used in minor hazard situations where a non immediate or potential hazard or unsafe practice presents a lesser threat of injury The caution icon and terminology may also alert the user to a situation that threatens equipment or performance WARNING Potential Biohazard Identifies the actual or potential presence of a biological hazar...

Page 28: ...nd Added 9211420A Original Issue Not Applicable 9211420B Section 1 8 Heading added 1 8 Red Cell Parameters Figures renumbered in Table of Contents 92420 01C Name change from Unipath to Abbott and changed PN 9211420 to List No 92420 01 9140240D 6 93 All pages 9140240E 5 95 All pages Search Go Back Book TOC ...

Page 29: ...l 9140240E May 1995 The Manual Revision Log on the next page is provided to document revisions to this manual The user should record the appropriate information and sign and date this log to provide a permanent record Search Go Back Book TOC ...

Page 30: ...______________________ ____________________ ____________________ ________________________________________ ____________________ ____________________ ________________________________________ ____________________ ____________________ ________________________________________ ____________________ ____________________ ________________________________________ ____________________ ____________________ ___...

Page 31: ...10 CELL DYN 3000 System Operator s Manual 9140240E May 1995 NOTES Search Go Back Book TOC ...

Page 32: ...ly 1 8 Waste Chambers 1 9 RBC PLT Metering Assembly 1 11 RBC PLT Transducer Assembly 1 11 HGB Flow Cell Assembly 1 11 WBC Transfer Peristaltic Pump 1 11 Overflow Chamber 1 12 WBC Mixing Chamber 1 12 HGB Mixing Chamber 1 12 WBC Flow Cell Cover 1 12 Optical Bench Assembly 1 12 Left Side Panel 1 12 Pinch Valves 1 13 Air Inlet Filters 1 13 Diluent Reservoir 1 13 Sheath Reservoir 1 14 Hemoglobin Lyse R...

Page 33: ...1 19 Right Side Panel 1 19 Data Station Serial Number Label 1 19 Contrast Control 1 20 Brightness Control 1 20 Power Switch 1 20 Rear Panel 1 20 Fan 1 21 Monitor Video Cable 1 21 External Computer Port 1 21 Analyzer Port 1 21 Graphics Printer Port 1 21 Ticket Printer Port 1 21 Keyboard Port 1 21 Data Station Power Receptacle 1 21 Computer Voltage Selector 1 21 Power Supply 1 21 Monitor Power Cord ...

Page 34: ...ument has two versions the automated Sample Loader or manual closed sampler An example of each version is shown in Figures 1 1 and 1 2 Figure 1 1 CELL DYN 3000SL The CELL DYN 3000SL is equipped with a separate Sample Loader module The Sample Loader provides continuous automated closed sampling for up to 100 tubes without operator intervention Analyzer Data Station Analyzer Pedestal Sample Loader S...

Page 35: ... 1 2 CELL DYN 3000CS The CELL DYN 3000CS is equipped with a built in manual closed sample aspiration module referred to as the closed sampler The closed sampler aspirates blood from a closed collection tube that has been inserted in the sampler module Analyzer Data Station Search Go Back Book TOC ...

Page 36: ...t M Monocyte percent EOS Eosinophil absolute count E Eosinophil percent BASO Basophil absolute count B Basophil percent RBC Red Blood Cell or Erythrocyte count HGB Hemoglobin concentration HCT Hematocrit MCV Mean Corpuscular Volume MCH Mean Corpuscular Hemoglobin MCHC Mean Corpuscular Hemoglobin Concentration RDW Red Cell Distribution Width PLT Platelet or Thrombocyte count MPV Mean Platelet Volum...

Page 37: ...1 4 CELL DYN 3000 System Operator s Manual 9140240E May 1995 System Description Chapter 1 NOTES Search Go Back Book TOC ...

Page 38: ...N 3000 System Components The two main modules of the CELL DYN 3000 are depicted in Figure 1 3 Analyzer The Analyzer contains the hardware to aspirate dilute and analyze each whole blood specimen Data Station The Data Station contains the computer video display monitor and keyboard Analyzer Data Station Search Go Back Book TOC ...

Page 39: ...at allows the operator to view the shear valve The cover is removed by lifting it up and away from the mounting brackets A grounding wire provides electrical continuity for shielding purposes Disconnect the grounding wire to allow the cover to be placed on top of the instrument Access to the upper flow panel is necessary to completely view the operation of the upper flow panel components and to pe...

Page 40: ...sequence Fault red light the Analyzer is unable to process specimens due to an existing fault condition Open Sample Aspiration Probe The open sample aspiration probe is used to aspirate whole blood from an opened collection tube The probe moves up into the wash block and remains there whenever the closed mode is selected Touch Plate The touch plate is located directly behind the open sample aspira...

Page 41: ...older It aspirates whole blood from either an open or closed collection tube into the shear valve The pump action is controlled by the touch plate and an optical detector Shear Valve Assembly The three piece ceramic shear valve isolates a precise volume of whole blood by means of a shearing action as the front and rear sections rotate The aspirated blood is isolated in three separate segments one ...

Page 42: ... of Hemoglobin Lyse into the HGB Mixing chamber at the same time as the diluted sample is dispensed into the HGB Mixing chamber WBC Sheath syringe delivers a specific volume of Sheath reagent to transport the blood from the shear valve to the WBC Mixing chamber WBC Metering syringe injects a specific volume of the WBC dilution into the WBC flow cell Waste Chambers The waste chambers collect the wa...

Page 43: ...PLT Metering Assembly Vacuum Accumulator Drain Lines Hydrophobic Filters Waste Chamber 2 Sample Aspiration Peristaltic Pump Shear Valve Assembly Status Indicator Panel READY BUSY FAULT Closed Sampler Module WBC Metering Syringe contains Sheath reagent WBC Sheath Syringe contains Sheath reagent HGB Lyse Syringe contains HGB Lyse HGB Diluent Syringe contains Diluent RBC Diluent Syringe contains Dilu...

Page 44: ... chambers The mixing chamber on the left is used to mix the RBC PLT dilution The counting chamber on the right contains the von Behrens plate used to prevent cells that have traversed the aperture from recirculating into the sensing zone Electrodes There are two non corrosive electrically conductive plates one positively charged and one negatively charged One electrode is located in each transduce...

Page 45: ...sample stream diluted WBCs The primary components of this assembly are Sample feed nozzle a specifically designed tube used to deliver the WBC dilution into the sheath stream WBC flow cell an optically clear quartz chamber with a central rectangular opening of a specific size which flares out into a cone at the top of the flow cell Optical Bench Assembly The optical bench assembly contains the hel...

Page 46: ...le air inlet filters that are inserted into the left side panel from the front The filters clean the air drawn into the Analyzer by the action of air circulation fans located on the rear panel Diluent Reservoir The Diluent reservoir maintains the Diluent supply within the Analyzer Analyzer Power Switch Auto Sampler Connector Waste Sensor Connector HGB Lyse Inlet Tube Connector Diluent Inlet Tube C...

Page 47: ...nstrument ON and OFF Auto Sampler Connector The Auto Sampler Connector port is used to attach the serial interface cable from the optional Sample Loader Waste Sensor Connector The Waste Full sensor plug connects to the waste sensor connector port When the electrical sensor is tripped the WASTE FULL message is generated and the READY status is inhibited until the situation is corrected The Analyzer...

Page 48: ...sible on the rear panel of the Analyzer are depicted in Figure 1 7 The functional description of each component follows Figure 1 7 Analyzer Rear Panel Components Fans A set of three fans cools the internal components of the Analyzer Line Frequency and Voltage Select Switch These switches are used to select the line frequency and voltage for the Analyzer Fuse The AC line fuse protects the Analyzer ...

Page 49: ...Power Connector This receptacle is used to connect the main power cord to the Analyzer RS 232 Connector This port is used by Abbott personnel Data Station Connector This connector is used to attach the cable that provides communication between the Data Station and the Analyzer Search Go Back Book TOC ...

Page 50: ...ormat may be output to a Laboratory Information System LIS through an RS 232 connector Data may be transmitted either automatically as samples are processed or by command of the operator Parallel data may be output to an on line printer Data Station Components The components visible on the front and right panels of the Data Station are shown in Figures 1 8 and 1 9 The full computer keyboard is als...

Page 51: ... keys labeled from 0 to 9 and a decimal key which are used to enter numeric data ENTER key stores entered numeric data and advances the cursor to the next entry location ESC key allows the operator to escape abort data entry before it is completed Arrow keys a set of four keys used to move the cursor in the direction depicted by each arrow Page Up key used to display the previous screen of data th...

Page 52: ...tation Floppy Disk Drive The floppy disk drive accepts 3 5 inch high density diskettes It is used to update the system software program and to download data Right Side Panel The components located on the right side panel of the Data Station are depicted in Figure 1 9 The functional description of each component follows Figure 1 9 Data Station Right Side Panel Components Data Station Serial Number ...

Page 53: ...f the Data Station are depicted in Figure 1 10 The functional description of each component follows Figure 1 10 Data Station Rear Panel Components NOTE Data Station output port location may vary Refer to the output port labels on the back of the Data Station for correct connections Fan This Port Not Used External Computer Port Graphics Printer Port Video Connector Analyzer Port Ticket Printer Port...

Page 54: ... This port is used to connect the printer cable when the printer is used to print data in a graphics format Ticket Printer Port This port is used to connect the printer cable when the printer is used to print data in a ticket format Keyboard Port This port is used to connect the standard computer keyboard Data Station Power Receptacle This receptacle is used to connect the main power cord to the D...

Page 55: ...ted Each CELL DYN 3000 system is tested at the factory using the specified reagents and all performance claims were generated using these reagents Reagents must be stored at room temperature to ensure optimal performance All reagents should be protected from direct sunlight extreme heat and freezing during storage Temperatures below 32 F 0 C may cause reagent layering that changes the tonicity and...

Page 56: ...lysate participates as a chromogen Sheath L N 99311 01 CELL DYN Sheath is formulated to Dilute the WBCs Osmotically lyse the red cells Maintain the light scattering properties of the WBCs Serve as a sheath fluid for the hydrodynamic focusing process Provide sufficient wetting action to prevent accumulation of air bubbles in the WBC flow system Provide acceptable WBC background count The following ...

Page 57: ...1 24 CELL DYN 3000 System Operator s Manual 9140240E May 1995 System Description Chapter 1 NOTES Search Go Back Book TOC ...

Page 58: ... Waste Requirements 2 3 Power Requirements 2 3 Printer Installation 2 3 Overview 2 3 Graphics Printer 2 4 Installation Procedure 2 4 Ticket Printer 2 5 Installation Procedure 2 5 Loading Individual Tickets in the Ticket Printer 2 7 Sample Loader 2 8 Installation 2 8 Mechanical and Electrical Setup 2 8 Fluid Tubing Connection 2 9 Tube Racks Setup 2 10 Power On 2 11 Search Go Back Book TOC ...

Page 59: ...Table of Contents 2 CELL DYN 3000 System Operator s Manual 9140240E May 1995 Table of Contents Chapter 2 NOTES Search Go Back Book TOC ...

Page 60: ...ly and to verify system performance NOTE Installation of the Analyzer by an unauthorized or untrained person could result in damage to the system and may void the warranty Never attempt to install the system without an authorized Abbott service representative present The remainder of this chapter gives general requirements for a successful installation Procedures are also included for installing t...

Page 61: ...equired beneath for Diluent Hemoglobin Lyse Sheath and waste container if one is used Allow six inches of space behind and on the left side of the Analyzer for air flow A constant circulating internal air stream is required to cool circuitry and components whenever the power is ON Also allow six inches of space behind the Data Station for air flow The Data Station may be placed in direct contact w...

Page 62: ...ched to the cap s electrode wires into the receptacle on the left side panel of the Analyzer labeled waste sensor If the waste tube is placed directly into a drain use a dummy plug in the receptacle as the WASTE FULL alert will activate if no plug is inserted Power Requirements Be sure that the system is located at the desired site before attempting any connections Four power outlets are required ...

Page 63: ...graphics report the printer cable must be connected to the graphics printer port on the rear of the Data Station 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 Data Station is turned OFF Remove the interface cabl...

Page 64: ...all the Abbott Customer Support Center for assistance at 1 800 CELL DYN or 1 800 235 5396 U S customers only Ticket Printer Installation Procedure The ticket printer is used to print result data on blank or pre printed tickets Blank tickets are available in continuous tractor feed sheets Pre printed tickets are loaded individually To print tickets the printer cable must be connected to the ticket ...

Page 65: ... power cord with two connectors from the accessory kit and plug one end into the port on the rear of the printer Fasten the wire clips to the connector for a secure connection 4 Plug the other end of the interface cable into the ticket printer port on the Data Station See Figure 2 1 Tighten the screws on the connector for a secure connection 5 Install the ribbon as directed in the printer manual 6...

Page 66: ...ator 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 and set the Top of Form by pressing and holding the TOF QUIET key and pressing the FORM FEED key to move the ticket up or pressing the LINE FEED key to mov...

Page 67: ...The pedestal is placed under the Analyzer and the Sample Loader is set on the platform Figure 2 2 Analyzer with Sample Loader Mechanical and Electrical Setup 1 Unpack the Sample Loader from its shipping container Place it on the platform as shown in Figure 2 2 2 Remove the protective plastic and inspect the module for damage Analyzer Data Station Analyzer Pedestal Sample Loader Platform Sample Loa...

Page 68: ... the Sample Loader accessory kit and inspect it for damage Connect the appropriate end of the cable to the port marked CH1 on the right side panel of the Sample Loader and secure the screws Connect the cable s other end to the connector labeled Auto Sampler on the left side panel of the Analyzer Secure the screws Fluid Tubing Connection 1 Locate the four tubes banded together and extending from th...

Page 69: ...o tubes by inserting the end of the aspiration tube leading from the top of the aspiration needle into the silicone sample aspiration tube Tube Racks Setup 1 Remove the 11 tube racks from the Accessory kit and inspect each for damage 2 Remove the bar code labels provided for the tube racks and inspect them for damage Apply bar coded rack ID labels to the indented area on the side of each tube rack...

Page 70: ...ack to advance Liquid spills that flow in the Sample Loader Control Panel could cause operational failure Notify the Customer Support Center for further assistance Figure 2 4 Tube Rack Showing Label Placement Location Power On 1 Turn the Sample Loader power switch on the right side panel to ON When the initialization process is complete the light above the Sample Loader START key flashes This indi...

Page 71: ...mples If necessary refer to the directions given in the Routine Operation section of Chapter 5 Operating Instructions 3 Confirm that the background count is acceptable before running patient samples Refer to the Routine Operation section of Chapter 5 Operating Instructions for instructions for running background counts Search Go Back Book TOC ...

Page 72: ...agent 3 8 Detection with the Optical Bench 3 8 WBC Differential 3 10 Mononuclear Polymorphonuclear Separation 3 10 Neutrophil Eosinophil Separation 3 11 Mononuclear Separation 3 12 Other Scatterplots 3 14 WBC Histograms 3 14 MONO POLY Histogram 3 15 LYM BASO MONO Histogram 3 15 WBC Parameters 3 15 WBC Flagging 3 16 RBC PLT Measurement 3 17 Overview 3 17 Electrical Impedance Measurements 3 17 Coinc...

Page 73: ...25 Hemoglobin Measurement Process 3 25 HGB Parameter 3 25 HGB Flagging 3 25 Operational Messages and Data Flagging 3 26 Overview 3 26 Instrument Fault and Status Conditions 3 26 Parameter Flagging Messages 3 27 Dispersional Data Alerts 3 28 Suspect Parameter Flags 3 28 WBC Flags 3 29 RBC Flags 3 30 PLT Flags 3 30 Suspect Population Flags 3 31 WBC Flags 3 31 RBC Flags 3 33 PLT Flags 3 33 Interpreti...

Page 74: ...ed explanation of the theory used for parameter derivation in each of the three methods will be given in the last section The three independent measurement channels used in the CELL DYN 3000 are The optical channel for determining the WBC count and differential data The impedance channel for determining the RBC and PLT data The Hemoglobin channel for determining the HGB data During each instrument...

Page 75: ...s selected the whole blood sample is aspirated into the Analyzer by the sample aspiration peristaltic pump The pump aspirates the sample through the shear valve An optical sensor checks the integrity of the sample Sample Analysis Cycle Overview NOTE Sample and reagent volumes given in this section are stated as the nominal values Slight differences between instruments may cause these volumes to va...

Page 76: ...the RBC PLT transducer assembly where the dilution is bubble mixed The final dilution is 1 12 501 3 The dilution is pulled through the aperture by vacuum The volumetric metering process ensures that 100 µL of the dilution are used for the measurement Electrical impedance is used to count the RBCs and PLTs as they traverse the aperture Hemoglobin Analysis 1 The 12 µL HGB sample segment is transport...

Page 77: ...y with Diluent 2 The needle used in either closed mode is rinsed internally and externally with Diluent 3 The WBC mixing chamber and WBC flow cell are rinsed with Sheath 4 The RBC PLT transducer assembly is rinsed with Diluent 5 The RBC PLT metering tube is coated with Hemoglobin Lyse 6 The HGB mixing chamber and HGB flow cell are rinsed with Hemoglobin Lyse Search Go Back Book TOC ...

Page 78: ...measures the traditional forward angle light scatter 1 3 referred to as 0 and orthogonal light scatter 70 110 referred to as 90 parameters Two additional scatters narrow angle light scatter 7 11 referred to as 10 and ninety degree depolarized scatter 70 110 referred to as 90 D are measured This is referred to as MAPSS for multi angle polarized scatter separation technology Various combinations of ...

Page 79: ...es quantitative cell analysis at the single cell level The basic components of a flow cytometer include A sample collector and transporter A flow system A light source and focusing optics Signal detectors Data collection and storage Data analysis and display In a flow cytometer the cell suspension is pumped from the specimen container through a sample tube into a special flow chamber with a small ...

Page 80: ...e then stored and analyzed by the computer Flow cytometers generally measure two angles of scatter Forward angle light scatter is roughly a measure of cell size Right angle orthogonal light scatter is primarily a measurement of internal granularity Combining the information from the two scatter measurements provides more accurate discrimination between cell populations than either single measureme...

Page 81: ...o altered by the Sheath reagent The RBCs are ruptured by hypo osmotic shock The RBC ghosts have the same refractive index as the Sheath reagent thereby rendering them invisible to the laser Detection with the Optical Bench The optical bench assembly contains the components that make up the flow cytometer It is depicted in Figure 3 3 The main purpose of the optical bench is to detect the light scat...

Page 82: ... This focused stream aligns the diluted cells in single file as they pass through the sensing region which allows them to be analyzed one at a time Figure 3 3 Optical Bench Since the average WBC is much smaller than the focused laser beam the cells do not scatter much laser light If the remaining so called axial light were allowed to reach the 0 detector it would saturate the electronics Therefore...

Page 83: ... is estimated to be below a predetermined value the instrument automatically continues to count WBCs for an extended count period The results from the two count periods are averaged The information from each detector is collected in list mode This format stores the channel information from each of the four dimensions The data is then used to determine the differential Data can be stored in the lis...

Page 84: ...3 4 Mononuclear Polymorphonuclear Scatter Neutrophil Eosinophil Separation The scatter information is plotted with the 90 D scatter on the Y axis and the 90 scatter on the X axis The 90 D 90 scatterplot is shown in Figure 3 5 This scatterplot separates the polymorphonuclear cells The mononuclear cells have been identified and therefore do not interfere in the further classification of the polymorp...

Page 85: ... the 10 scatter on the X axis The 0 10 scatterplot is shown in Figure 3 6 The mononuclear cells are plotted on this scatterplot The algorithm also uses the orientation of the neutrophil cluster to aid in classifying the mononuclears Three populations of mononuclear cells are clearly seen on the display There are three populations of mononuclears because basophils are included in the mononuclear cl...

Page 86: ...t uses dynamic thresholds to determine the best separation between the three main populations Each cell is then classified as a LYMPH a MONO or a BASO Figure 3 6 Mononuclear Scatter Finally the instrument evaluates the area below the lymphocyte cluster but above the hardware threshold channel 23 Any particles that fall in this area are separated from the lymphocytes by a dynamic threshold The foll...

Page 87: ...atter on the Y axis and the 0 scatter on the X axis 90 D 10 The scatter information is plotted with the 90 D scatter on the Y axis and the 10 scatter on the X axis All scatterplots may be displayed and printed at operator request WBC Histograms The CELL DYN 3000 can present the WBC scatter information as two histograms See Figure 3 7 These histograms may be displayed and printed at the operator s ...

Page 88: ... the lymphocyte basophil and monocyte size distribution data on the X axis WBC Parameters The WBC data is generally displayed as depicted in Figure 3 8 All numeric and graphic data are automatically displayed on the Data Station RUN Screen in the format selected After the WBC scatter information has been plotted and the cells have been classified into the five subpopulations the instrument determi...

Page 89: ...wing colors Neutrophils yellow Lymphocytes blue Monocytes magenta Eosinophils green Basophils white The WBC scatter information is usually displayed in two scatterplots as shown in Figure 3 8 SIZE COMPLEXITY The size 0 scatter information is plotted on the Y axis and the complexity 10 scatter information is plotted on the X axis DEPOL ORTHOGONAL The granularity Depol 90 D scatter information is pl...

Page 90: ...ure a transitory change in the resistance between the electrodes is produced This change produces a measurable electrical pulse The number of pulses generated is indicative of the number of particles that traversed the aperture The amplitude of each pulse is essentially proportional to the volume of the particle that produced it Each pulse is amplified and compared to internal reference voltage ch...

Page 91: ...f diluted whole blood that passes through the aperture during the count cycle is known 1 The CELL DYN 3000 utilizes the volumetric metering process to regulate the count cycle and ensure that a precise volume of sample is used for the RBC PLT measurement The RBC PLT metering assembly contains a precision bore glass tube fitted with two optical detectors See Figure 3 9 The distance between the dete...

Page 92: ... count time is displayed on the Data Station RUN Screen to the right of the MPV result If an RBC metering fault was detected one of two messages is displayed and printed the RBC CLOG message if either time is too slow or the RBC FLOW ERROR message if either time is too fast Both the RBC upper metering time UMT and the RBC count time CNT are displayed and printed when an RBC metering fault occurs R...

Page 93: ...e format selected The size distribution data for the red cells is displayed graphically as a histogram The size distribution data is plotted on the X axis The relative number of cells is normalized and plotted on the Y axis The RBC data are shown in Figure 3 10 Figure 3 10 RBC Data and Histogram RBC Count The Red Blood Cell RBC count is directly measured gives the number of RBCs and is expressed a...

Page 94: ... from the RBC and the HGB as follows MCH HGB RBC x 10 MCHC The Mean Corpuscular Hemoglobin concentration MCHC is the ratio of the weight of hemoglobin to the volume of the average red blood cell expressed in grams per deciliter It is calculated from the HGB and the HCT as follows MCHC HGB HCT x 100 RDW Red Cell Distribution Width RDW is a measure of the heterogeneity of the RBC population RDW is a...

Page 95: ...floats in the 15 35 fL region Once the thresholds have been determined the PLT count is derived from the data between them Interference in the upper threshold region is generally caused by microcytic RBCs Therefore after the PLT upper threshold has been determined the data between it and the RBC lower threshold is reevaluated If the PLT upper threshold is less than 35 fL the counts above it but le...

Page 96: ...een analyzed by the platelet algorithm The PLT count is expressed as follows PLT x 103 µL MPV The Mean Platelet Volume MPV is derived from the PLT histogram after the PLT count has been determined The MPV is expressed in femtoliters PCT The Plateletcrit PCT 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 Sear...

Page 97: ...ution Width PDW is a measure of the heterogeneity of the PLT population It is expressed as the geometric standard deviation NOTE PCT and PDW are not reportable parameters Platelet Flagging Refer to the Operational Messages and Data Flagging section of this chapter for PLT flagging information Search Go Back Book TOC ...

Page 98: ... The LED shines through the flow cell and a 540 nm narrow bandwidth filter onto a photodetector The Hemoglobin concentration is directly proportional to the absorbance of the sample at 540 nm Five separate HGB readings are made on each sample and averaged to give the final HGB sample reading After the Hemoglobin readings have been made the HGB flow cell is rinsed with Hemoglobin Lyse The rinse is ...

Page 99: ...ories 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 discussed in detail in the Troubleshoot...

Page 100: ...a if above upper limit Result underlined on graphics printout when limits exceeded Result underlined on blank ticket when limits exceeded Result marked with asterisk on preprinted ticket when results exceeded WBC Leukopenia Leukocytosis Differential NEU LYM MONO EOS BASO Same as WBC DIFF NLMEB BAND IG BLAST VAR L Neutropenia Neutrophilia Lymphopenia Lymphocytosis Monocytosis Eosinophilia Basophili...

Page 101: ...Specimens with results that exceed the linearity should be diluted with Diluent according to the laboratory s procedure and repeated Be sure to correct the results for the dilution factor used NOTE MCV MCH MCHC and MPV are unaffected by dilution CAUTION When entering limits into the four patient limit sets ensure that the upper and lower limits for each parameter DO NOT EXCEED the Linearity Specif...

Page 102: ...sample using the Resistant RBC specimen type Specimens with suspected fragile WBC populations should not be run in the Resistant RBC mode DIFF NLMEB displayed next to the BASO result Cause 1 A default preset value or threshold was used to determine the five part differential This is typically due to the presence of abnormal cell clusters that the instrument cannot reliably discriminate between and...

Page 103: ...rference The flag may be caused by Debris dirty aperture Contaminated reagent Electronic noise Microbubbles Action Check the background count If it exceeds the limits troubleshoot as directed in the Troubleshooting Guide If it is within limits repeat the specimen If the flag persists review a stained smear to determine the cause of the interference and confirm the PLT count URI Upper Region Interf...

Page 104: ...Repeat the sample If the flag remains verify the PLT count Suspect Population Flags These flags are generated when the instrument s evaluation of the measured data for a particular parameter or group of parameters indicates the possible presence of an abnormal subpopulation A stained smear should be reviewed whenever a suspect population flag is present Therefore instructions for interpreting thes...

Page 105: ...is 20 of the total WBC count 3 The MONO is 3 of the total WBC count and the standard deviation of the monocytes on the 0 axis exceeds expected criteria Action Review a stained smear and follow your laboratory s review criteria When blasts are present they are included in the monocyte count VAR LYM displayed next to the LYM result Cause The distribution of the lymphocyte cluster on the size complex...

Page 106: ...ed limits MCV 80 fL or 100 fL MCH 25 pg or 34 pg MCHC 29 g dL or 37 g dL RDW 18 5 Action Review a stained smear and follow your laboratory s review criteria PLT Flags No MPV result displayed data suppressed Cause The PLT histogram did not meet expected criteria non log normal distribution Action Review a stained smear for abnormal PLT morphology or the presence of PLT aggregates and follow your la...

Page 107: ...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 lower limit for RBCs Polycythemia result exceeds the upper limit for RBCs Microcytic RBC result exceeds the lower limit for MCV Macrocytic RBC result exceeds the upper limit for MCV Hypochro...

Page 108: ...eferences 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 Search Go Back Book TOC ...

Page 109: ...3 36 CELL DYN 3000 System Operator s Manual 9140240E May 1995 Principles of Operation Chapter 3 NOTES Search Go Back Book TOC ...

Page 110: ...ar Code Label Specifications 4 5 Physical Specifications CELL DYN 3000CS 4 6 Power Specifications CELL DYN 3000CS 4 7 Consumption 4 7 Operational Specifications CELL DYN 3000CS 4 8 Operating Environment 4 8 Complete Cycle Times 4 8 Approximate Aspiration Volumes whole blood 4 8 Measurement Specifications CELL DYN 3000SL and CS 4 9 Measurement Channels 4 9 WBC and Differential 4 9 RBCs and PLTs 4 9...

Page 111: ...Table of Contents 2 CELL DYN 3000 System Operator s Manual 9140240E May 1995 Table of Contents Chapter 4 NOTES Search Go Back Book TOC ...

Page 112: ...Height 24 61 cm 24 61 cm 6 15 cm 17 42 cm Width 30 76 cm 15 38 cm 16 5 41 cm 28 71 cm Depth 22 56 cm 22 56 cm 14 5 39 cm 11 5 29 cm Weight 190 lb 86 kg 73 lb 33 kg 16 5 lb 7 5 kg 53 lb 24 kg Analyzer Data Station Printer Sample Loader Height 36 91 cm 37 94 cm 9 5 24 cm 35 89 cm Width 40 102 cm 21 53 cm 21 53 cm 21 53 cm Depth 30 76 cm 27 69 cm 18 5 46 cm 35 89 cm Weight 310 lb 141 kg 134 lb 61 kg ...

Page 113: ...ts maximum 4760 BTU per hour Analyzer Input Requirements Setting Range Frequency 100 90 110 VAC 50 60 Hz 120 110 130 VAC 50 60 Hz 220 200 240 VAC 50 60 Hz 240 220 250 VAC 50 60 Hz Data Station Input Requirements Setting Range Frequency 120 90 130 VAC 50 60 Hz 240 180 260 VAC 50 60 Hz Printer Input Requirements Setting Frequency 120 50 60 Hz Sample Loader Input Requirements Setting Range Frequency ...

Page 114: ...ay exhibit an increase at lower environmental temperatures 18oC Relative Humidity 10 to 85 RHNC Complete Cycle Times Auto Startup from STANDBY Approximately 5 5 minutes Auto Startup from power OFF Approximately 7 minutes Run Open mode Approximately 40 seconds READY to READY Run Sample Loader Approximately 49 seconds Shutdown to STANDBY 7 5 minutes The laser requires a 15 minute warm up time If the...

Page 115: ... samples that do not generate any instrument operational messages Collection Tube and Sample Volume 13 mm diameter x 75 mm high with a Hemoguard style closure Minimum sample volume 1 mL using the Sample Loader Maximum sample volume 3 mL using the Sample Loader NOTE The sample volume in the tube must be within the specified limits for adequate mixing and sampling Search Go Back Book TOC ...

Page 116: ...Codabar Bar Code Label Specifications Bar code labels must meet the following specifications Printed on good quality label stock 0 25 inch quiet zone on each end 0 01 inch minimum narrow bar width 2 1 wide to narrow bar ratio 0 5 inch minimum bar length 2 inch maximum label length 1 25 inch maximum label width NOTE Refer to Appendix A for complete information on bar code label formats check digits...

Page 117: ...r Shipment Analyzer Data Station Printer Height 24 61 cm 24 61 cm 6 15 cm Width 30 76 cm 15 38 cm 16 5 41 cm Depth 22 56 cm 22 56 cm 14 5 39 cm Weight 190 lb 86 kg 73 lb 33 kg 16 5 lb 7 5 kg Analyzer Data Station Printer Height 36 91 cm 37 94 cm 9 5 24 cm Width 40 102 cm 21 53 cm 21 53 cm Depth 30 76 cm 27 69 cm 18 5 46 cm Weight 310 lb 141 kg 134 lb 61 kg 21 lb 9 5 kg Search Go Back Book TOC ...

Page 118: ...300 Watts Printer 145 Watts 1345 Watts maximum 4590 BTU per hour Analyzer Input Requirements Setting Range Frequency 100 90 110 VAC 50 60 Hz 120 110 130 VAC 50 60 Hz 220 200 240 VAC 50 60 Hz 240 220 250 VAC 50 60 Hz Data Station Input Requirements Setting Range Frequency 120 90 130 VAC 50 60 Hz 240 180 260 VAC 50 60 Hz Printer Input Requirements Setting Frequency 120 VAC 50 60 Hz Search Go Back Bo...

Page 119: ...C Background values for RBC and PLT may exhibit an increase at lower environmental temperatures 18oC Relative Humidity 10 to 85 RHNC Complete Cycle Times Auto Startup from STANDBY Approximately 5 5 minutes Auto Startup from power OFF Approximately 7 minutes Run Open mode Approximately 40 seconds READY to READY Shutdown to STANDBY 7 5 minutes The laser requires a 15 minute warm up time If the power...

Page 120: ...nt 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 Aperture Impedance Aperture Size 60 µm diameter x 72 µm length Dilution 1 12 501 of blood in diluent Data Collection 256 channels for RBCs each RBC channel 1 fL 256 channels for PLTs each PLT channel 0 137 fL HGB Method Modified hemiglobincyanide Li...

Page 121: ...fall within the laboratory s normal range These samples should not display any of the following suspect parameter flags WBC LRI URI LURI The stated precision values are applicable to the Open Closed Sampler and Sample Loader modes Hemogram Parameters Precision specifications for the hemogram parameters are given as the coefficient of variation CV of at least 20 determinations of the same sample Ta...

Page 122: ...es and displays no suspect parameter flags Specifications are determined by taking multiple measurements on each dilution to minimize the effect of imprecision The stated limits are determined by regression analysis with the line going through the origin 0 0 Table 4 9 Linearity Specifications Cell Type Range 95 Confidence Limit Neutrophil 42 65 2 1 Lymphocyte 24 45 3 2 Monocyte 3 6 11 0 2 9 Eosino...

Page 123: ... this manual bias between the modes is clinically insignificant Accuracy specifications are determined by correlation to reference values obtained from comparison analyzers or analysis by reference methodology Samples that are used for correlation studies should not display any suspect parameter flags Hemogram Parameters Table 4 10 Accuracy of Hemogram Parameters WBC Differential Parameters Table ...

Page 124: ... in triplicate followed by three background cycles The percent carryover is calculated using the following formula Carryover Background1 Background3 x 100 ______ Sample3 Background3 Absolute Carryover Background1 Background3 Table 4 12 Carryover for WBC RBC HGB and PLT WBC RBC HGB PLT Level 90K µL 6 9M µL 20 6 g dL 721 K µL Carryover in or Absolute 1 0 or 0 1 1 0 or 0 03 1 0 or 0 1 1 0 or 10 Searc...

Page 125: ...4 14 CELL DYN 3000 System Operator s Manual 9140240E May 1995 System Specifications Chapter 4 NOTES Search Go Back Book TOC ...

Page 126: ...ure Lot Number Entry 5 22 Procedure Replicate ID Entry 5 23 Procedure Customize QC Log Display 5 25 Procedure Customize QC Log Display Standard Groups 5 27 Procedure Customize QC Log Printout 5 29 Procedure Bar Code Set Up 5 31 Procedure Computer Setup 5 34 Procedure Units Selection 5 36 Procedure Customize Display 5 38 Procedure Customize Graphics Report 5 43 Procedure Customize Graphics Header 5...

Page 127: ...out Q Labels Procedure 5 76 Running Samples 5 77 Open Mode Analysis 5 77 Open Mode Procedure 5 77 Closed Mode Analysis 5 78 Closed Mode Procedure 5 78 Daily Shutdown 5 79 Sample Analysis on the CELL DYN 3000CS 5 80 Daily Start Up Procedure 5 80 Start Up Procedure 5 80 Daily Quality Control Checks 5 80 QC Open or Closed Mode Procedure 5 81 Running Samples 5 81 Open Mode Analysis 5 81 Open Mode Proc...

Page 128: ...re 5 98 Running STAT Samples 5 99 Using the Data Log 5 101 Introduction 5 101 Data Log Menu 5 101 Data Log Codes 5 111 Data Log Set Up Procedures 5 112 Customizing the Data Log Display 5 112 Procedure Customize Data Log Display 5 113 Standard Groups 5 114 Procedure Customize Data Log Display Standard Groups 5 114 Customizing the Printout 5 116 Procedure Customize Data Log Printout 5 116 Data Revie...

Page 129: ...Table of Contents 4 CELL DYN 3000 System Operator s Manual 9140240E May 1995 Table of Contents Chapter 5 NOTES Search Go Back Book TOC ...

Page 130: ...libration Chapter 6 Quality Control Chapter 7 Maintenance Chapter 9 Troubleshooting Chapter 10 Data Station Program Overview The Data Station menus are presented as key labels displayed across the bottom of the screen Each menu is accessed by pressing the soft key located directly below the label From left to right these soft keys correspond to keys F1 F8 on the standard computer keyboard When the...

Page 131: ...e OPERATOR ID field when the MAIN MENU Screen is displayed An operator ID of up to three alphanumeric characters may be entered An operator ID may also be entered from the main CALIBRATION Screen This operator ID will be displayed on all other 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 i...

Page 132: ...ter 5 Operating Instructions The MAIN MENU key labels are displayed across the bottom of the screen Conventions Used in This Manual Please refer to the introduction of this manual for a key to style conventions used in this and other chapters Search Go Back Book TOC ...

Page 133: ...5 4 CELL DYN 3000 System Operator s Manual 9140240E May 1995 Operating Instructions Chapter 5 NOTES Search Go Back Book TOC ...

Page 134: ...The function of each key is discussed and set up procedures are given where applicable Figure 5 2 Setup Menu Screen When the SETUP key is pressed the following soft key labels are displayed DATE TIME PATIENT LIMITS REAGENT LOG QC SETUP MENU OPERATION SETUP UNITS SELECTION CUSTOMIZE REPORT MAIN DATE TIME PATIENT LIMITS REAGENT LOG QC SETUP MENU OPERATION SETUP UNITS SELECTION CUSTOMIZE REPORT MAIN ...

Page 135: ...ailable The numbers on the DATE TIME SETUP 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 RETURN DATE TIME SETUP Ready Dec 08 1992 Operator ID Sequence 15 52 734 0067 Enter desired date display option and or set date and time 1 1 Month Da...

Page 136: ... DATE TIME SETUP Screen 2 Type the number of the desired format at the cursor 3 Press the Enter key on the keyboard to save the entry and advance to the DATE entry field 4 Type the date in the selected format using one or two digits Separate the day month and year 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 keybo...

Page 137: ...s will be flagged for further review The following soft key labels are displayed see Figure 5 4 when the PATIENT LIMITS key is pressed LIMIT SET 1 LIMIT SET 2 LIMIT SET 3 LIMIT SET 4 PRINT RETURN LIMIT SET 2 LIMIT SET 3 LIMIT SET 4 PRINT RETURN LIMIT SET 1 Ready Jun 30 1992 Operator ID Sequence 11 15 734 6799 WBC NEU LYM MONO EOS BASO RBC HGB HCT MCV MCH MCHC RDW PLT MPV PCT PDW Upper Limits 4 6 2...

Page 138: ... PATIENT LIMITS Screen A Patient Limit Set is displayed on the screen The set number Limit Set 1 Limit Set 2 etc is displayed in the Status Box The other limit sets may be selected by pressing the appropriate soft key 2 Use the Arrow keys on the keyboard to move the cursor to the desired limit entry field and type the number 3 Press the Enter key on the keyboard to save the entry and automatically...

Page 139: ...e displayed when the REAGENT LOG key is pressed DELETE ENTRY DILUENT LOG HGB LYSE LOG SHEATH LOG PRINT LOG RETURN NOTE The key label for the reagent log displayed on the screen is not shown DELETE ENTRY HGB LYSE LOG SHEATH LOG PRINT LOG RETURN DILUENT LOG Ready Dec 17 1992 Operator ID Sequence 16 30 734 0630 Package Size 20 20 Lot Number 013511 013511 Expiration Date 02 28 93 02 28 93 Open Date 12...

Page 140: ... 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 printout of the log 8 Pre...

Page 141: ...f the QC files see Figure 5 6 and the following soft key labels X B SETUP LAB ID SETUP QC LIMITS SET UP QC FILE CUSTOMIZE DISPLAY CUSTOMIZE PRINTOUT RETURN X B SETUP LAB ID SETUP QC LIMITS SET UP QC FILE CUSTOMIZE DISPLAY CUSTOMIZE PRINTOUT RETURN QC SETUP MENU Ready Dec 08 1992 Operator ID Sequence 15 57 734 0067 1 2 3 4 5 6 7 8 9 10 File Name Select a QC file with the arrow keys or enter a new f...

Page 142: ...acceptance limits target values and action limits for the X B Moving Average QC Program The following soft key labels are displayed when the X B SETUP key is pressed TURN X B ON or TURN X B OFF The key label alternates between these two selections when the soft key is pressed PRINT RETURN TURN X B OFF PRINT RETURN X B SETUP Ready Dec 08 1992 Operator ID Sequence 16 10 734 0067 Parameter MCV MCH MC...

Page 143: ...ed on the instrument NOTE The default preassigned Target Values on the X B SETUP Screen shown in Figure 5 7 are not Dr Bull s Target Values Dr Bull s Target Values are included in the X B Analysis section of Chapter 7 Quality Control 3 ACTION LIMIT The Action Limit is the acceptable limit of variation around the target value NOTE The X B Program is discussed in detail in Chapter 7 Quality Control ...

Page 144: ... following this number The status may be OUT OUT2 or IN OUT indicates that the mean of the previous batch was outside the action limits OUT2 indicates that the mean of the last 2 or more completed batches fell outside the action limits IN indicates that the mean of the previous batch was within the action limits The feature enabling the transfer of QC limits and data into a QC file from a floppy d...

Page 145: ...by pressing the QC LIMITS key This key is available on the QC SETUP MENU Screen and the QC MENU Screen Two types of QC limits are available RANGE ENTRY used to enter the upper and lower flagging limits absolute numbers see Figure 5 8 MEANS AND LIMITS used to enter the mean value and a range value that defines the upper and lower flagging limits see Figure 5 9 If Range Entry is selected by pressing...

Page 146: ...xt 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 MEANS LIMITS UPDATE FROM FILE LOAD FROM DISK PRINT RETURN QC RANGE ENTRY Ready Jun 08 1992 Operator ID Sequence 10 23 734 9110 FOR NORM RD43 SL WBC NEU LYM MONO EOS BASO RBC HGB HCT MCV MCH MCHC RDW PLT MPV PCT PDW Lower Limits 6 9 3 5 2 4 0 6 0 0 0 0 4 20 13 1 36 3 8...

Page 147: ...cursor into the desired file 2 Press QC LIMITS followed by MEANS LIMITS to display the 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 RANGE ENTRY LOAD FROM DISK PRINT RETURN QC MEANS LIMITS ENTRY Ready May 18 1992 Operator ID Sequence 11 35 734 4300 FOR NORM RD43 SL WBC NEU LYM MONO EOS BASO RBC HGB HCT MCV MCH ...

Page 148: ...and the limit would be adjusted to 1 5 7 If desired press QC LIMITS to return to the MEANS LIMITS ENTRY Screen and press PRINT to obtain a printout of the entered values The UPDATE FROM FILE key is displayed on the QC MEANS LIMITS ENTRY and QC RANGE ENTRY Screens when there are two or more results in the file See the previous figure When the UPDATE FROM FILE key is pressed the bulletin line displa...

Page 149: ...screen is also used to select the Westgard Rules that will be applied to the QC data stored in the file The following soft key labels are displayed when the SETUP QC FILE key is pressed REPLICATE ID or LOT NUMBER The key label alternates between these two selections TOGGLE ON OFF This key label is present only when the cursor is in one of the Westgard Rule Selection fields PRINT RETURN The LOT NUM...

Page 150: ...ide SAME 2 SD RULE 5 Four Consecutive values outside SAME 1 SD RULE 6 Ten Consecutive values on SAME side of mean NOTE Westgard Rules are discussed in detail in the Quality Control chapter of this manual The Westgard Rule selections are available on either of the QC FILE SETUP Screens LOT NUMBER PRINT RETURN QC FILE SETUP Ready Dec 17 1992 Operator ID Sequence 16 36 734 0630 Replicate ID FOR Low W...

Page 151: ...the selected file 6 Press SETUP QC FILE to display the QC FILE SETUP Screen Procedure Lot Number Entry 1 If necessary from the QC FILE SETUP Screen press LOT NUMBER to display the LOT NUMBER and EXPIRATION DATE entry fields REPLICATE ID PRINT RETURN QC FILE SETUP Ready Dec 17 1992 Operator ID Sequence 16 35 734 0630 Lot Number FOR Low 12345 Expiration Date Month Day Year 11 30 92 WESTGARD RULE SEL...

Page 152: ...ursor at the desired Westgard Rule 6 Press TOGGLE ON OFF to enable the rule and advance the cursor 7 Repeat steps 5 and 6 until all desired rule selections have been made 8 If desired press PRINT to obtain a printout of the entries 9 Press RETURN to return to the QC FILE SETUP Screen Procedure Replicate ID Entry 1 If necessary from the QC FILE SETUP Screen press REPLICATE ID to display the REPLICA...

Page 153: ...following parameters are included in the list and may be displayed in the QC file if desired UMT1 and UMT2 UMT1 is the RBC PLT Upper Metering Time UMT2 is the RBC PLT Upper Metering Time for an extended count CNT1 and CNT2 CNT1 is the RBC PLT Count Time CNT2 is the RBC PLT Count Time for an extended count EMPTY Inserts an empty column in the QC Log File display SELECT PARAMETER STANDARD GROUPS RET...

Page 154: ...n for the selected file 3 If necessary press CUSTOM PLACEMENT to display the CUSTOMIZE QC DISPLAY Screen and the SELECT PARAMETER key 4 Use the Arrow keys on the keyboard to move the cursor to the desired parameter in the listing under the matrix 5 Press SELECT PARAMETER The selected parameter is highlighted and the cursor moves to the first position in Group 1 NOTE The key label changes to PLACE ...

Page 155: ...ey labels are displayed WBC GROUP RBC GROUP PLT GROUP DIFF GROUP LATEX SET CUSTOM PLACEMENT RETURN This key is used to return to the CUSTOMIZE QC DISPLAY Screen for operator selected placement WBC NEU LYM MONO EOS BASO RBC HGB HCT MCV MCH MCHC RDW PLT MPV PCT PDW WBC N L M E B WBC NEU LYM MONO EOS BASO RBC HGB HCT MCV MCH MCHC RDW PLT MPV PCT PDW N L M E B UMT1 UMT2CNT1 CNT2 EMPTY WBC GROUP RBC GR...

Page 156: ...rst screen Group 2 on the 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 SETUP MENU Screen 9 Repeat this p...

Page 157: ...hat is currently selected A list of all available parameters is displayed under the group The following parameters are included in the list and may be printed in the QC Log if desired UMT1 and UMT2 UMT1 is the RBC PLT Upper Metering Time UMT2 is the RBC PLT Upper Metering Time for an extended count SELECT PARAMETER STANDARD SELECTION RETURN CUSTOMIZE QC PRINTOUT Ready Dec 17 1992 Operator ID Seque...

Page 158: ...or moves to the first position in the group NOTE The key label changes to PLACE PARAMETER and a CANCEL SELECTION key is displayed 5 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 t...

Page 159: ...een see Figure 5 15 allows the operator to configure the transmission to an on line computer The following soft key labels are displayed when the OPERATION SETUP key is pressed BAR CODE SETUP COMPUTER SETUP RETURN BARCODE SETUP COMPUTER SETUP RETURN OPERATION SETUP MENU Ready Dec 08 1992 Operator ID Sequence 16 11 734 0067 OPERATION SETUP Search Go Back Book TOC ...

Page 160: ...alyzer reads all three types of bar codes NOTE For more information about check digits and bar codes refer to Appendix A Bar Codes Procedure Bar Code Set Up 1 From the OPERATION SETUP MENU Screen press BAR CODE SETUP to display the BAR CODE SETUP Screen 2 Type the number for the type of bar code that will be used 1 Code 39 2 Interleaf 2 of 5 3 Codabar Press the Enter key on the keyboard to save th...

Page 161: ...y Information System Data may be transmitted automatically as each sample is run or at the operator s request The CELL DYN 3000 also can receive patient information transmitted to it by the on line computer REINIT INTERFACE STOP TRANSMISS TOGGLE ON OFF RETURN COMPUTER SETUP Ready Dec 08 1992 Operator ID Sequence 16 13 734 0070 OFF OFF OFF OFF OFF 8 1 0 0 3 9600 Auto transmission of ALERTED paramet...

Page 162: ...When the STOP TRANSMISS key is pressed the following soft key labels are displayed CONFIRM STOP CANCEL STOP These keys confirm or cancel the Stop Transmission command The TOGGLE ON OFF key enables or disables the first five options in the list displayed on the COMPUTER SETUP Screen The numbers on the COMPUTER SETUP Screen shown in Figure 5 17 correspond to the following numbered options 1 Auto tra...

Page 163: ...t Center at 1 800 CELL DYN Procedure Computer Setup 1 From the OPERATION SETUP MENU Screen press COMPUTER SETUP to display the COMPUTER SETUP 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...

Page 164: ...is pressed USA UNITS SI UNITS SI MOD UNITS MIXED UNITS SELECT UNITS RETURN The units selected by each of the soft keys are shown on the screen display in Figure 5 18 The following table shows an example of the same sample displayed with each of the four units selections USA UNITS SI UNITS SI MOD UNITS MIXED UNITS SELECT UNITS RETURN UNITS SELECTION Ready Dec 08 1992 Operator ID Sequence 16 16 734 ...

Page 165: ...on the display 5 Use the Arrow keys on the keyboard to move the cursor to the next unit to be selected 6 Repeat steps 3 5 until all 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 SETUP MENU Screen Parameter USA SI SI MOD MIXED Value Units Value Units Value Units Value Units WBC 5 32 K µL 5...

Page 166: ...ZE DISPLAYED REPORT Screen appears see Figure 5 19 for the indicated parameter set and the following soft key labels are displayed when the CUSTOMIZE DISPLAY key is pressed PARAM SET 1 CUSTOMIZE REPORT PARAM SET 2 PARAM SET 3 PARAM SET 4 CUSTOMIZE PRINTOUT CUSTOMIZE HEADER SELECT GRAPH SETUP CUSTOMIZE DISPLAYED REPORT Ready May 11 1992 Operator ID Sequence 11 09 734 3452 ON WBC ON NEU ON N O N LYM...

Page 167: ...pty selection may be used to blank the scatterplot or histogram display at the selected position The screen is divided into two sections Individual parameters are listed in the left section and the scatterplots and histograms are listed in the right section Procedure Customize Display 1 From the SETUP MENU Screen press CUSTOMIZE REPORT and if necessary press CUSTOMIZE DISPLAY to display a paramete...

Page 168: ...es through the entire list of scatterplots and histograms Repeat steps 3 8 until all desired selections have been made for the current Parameter Set 10 If desired press the Print Screen key on the keyboard to obtain a printout of the selected Parameter Set 11 Press PARAM SET X to select another Parameter Set and repeat steps 3 10 to customize the display for it 12 Press SETUP to return to the SETU...

Page 169: ...are grouped according to the type of printer selected The CUSTOMIZE DISPLAY key is used to customize the display as discussed in the preceding section The STOP PRINTING key is used to stop printing that is in progress When the STOP PRINTING key is pressed the following soft key labels are displayed CONFIRM STOP CANCEL STOP These keys confirm or cancel the stop printing command If CONFIRM STOP is p...

Page 170: ...tion is enabled a report is automatically printed for any sample without flagged results 3 Print graphs for ALERTED specimens only SETUP TICKET PRINTER CUSTOMIZE DISPLAY STOP PRINTING CUSTOMIZE HEADER TOGGLE ON OFF SETUP CUSTOMIZE PRINTED REPORT Ready Dec 08 1992 Operator ID Sequence 16 58 734 0630 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF 66 AUTO PRINT results for ALERTED specimens AUTO PRINT resul...

Page 171: ...es and Data Flagging section of Chapter 3 Principles of Operation for an explanation of the Interpretive Report messages 7 Print Limits Report When this option is enabled the Patient Limits set that was applied to the results is printed on the report 8 Print Manual Differential Grid for ALERTED specimens When this option is enabled a grid that can be used to report a manual Differential is printed...

Page 172: ...Type the desired number of line feeds in the entry field and press the Enter key on the keyboard to save the entry and advance the cursor An 8 1 2 x 11 sheet of paper has 66 lines per page 6 If desired press the Print Screen key on the keyboard to obtain a printout of the selections 7 If desired press SETUP to return to the SETUP MENU Screen or continue with the following procedure for customizing...

Page 173: ...omize Graphics Header 1 From any CUSTOMIZE PRINTED REPORT Screen press CUSTOMIZE HEADER to display the CUSTOMIZE PRINTOUT HEADER Screen 2 Type the desired number of lines for the header in the indicated field The header can include up to four lines 3 Press the Enter key on the keyboard to save the entry and advance to the next entry field 4 Press TOGGLE ON OFF to enable or disable the PRINT CURREN...

Page 174: ...oft key is pressed The PRE PRNTD TICKET key is used to customize the printed report for a preprinted ticket The BLANK TICKET key is used to customize the printed report for a blank ticket Figure 5 22 Customize Printed Report Screen for Pre Printed Tickets TICKET PRINTER BLANK TICKET GRAPHICS PRINTER CUSTOMIZE DISPLAY STOP PRINTING CUSTOMIZE HEADER TOGGLE ON OFF SETUP CUSTOMIZE PRINTED REPORT Ready...

Page 175: ...on is enabled results for specimens that are not flagged are automatically printed as tickets are inserted in the printer 4 Print PCT PDW results When this option is enabled the PCT and PDW are printed on the ticket NOTE Clinical significance has not been established for these parameters Therefore they are not reportable Procedure Customize Pre Printed Ticket 1 From the CUSTOMIZE PRINTED REPORT Sc...

Page 176: ...ECIFIC 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 this option is enabled a report is automatically printed for any sample without flagged results RESTORE HEADER PRE PRNTD TICKET GRAPHICS PRINTER CUSTOMIZE DISPLAY STOP PRINTING CUSTOMIZE HEADER TOGGLE ON OFF SETUP CUSTOMIZE PRIN...

Page 177: ...t Manual 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 9 Line feeds per page for ticket printer 1 to 99 This option is used to select the size of the printed report A blank ticket typically has 68 lines 10 Number of lines for the customize ticket header 0 ...

Page 178: ...y field and press the Enter key on the keyboard to save the entry and advance the cursor 7 Type the desired number of lines for the header and press the Enter key on the keyboard to save the entry and advance the cursor 8 Type the first line of the header and press the Enter key on the keyboard to save the entry and advance the cursor Each line holds 35 characters If desired type a second line and...

Page 179: ...5 50 CELL DYN 3000 System Operator s Manual 9140240E May 1995 Operating Instructions Chapter 5 NOTES Search Go Back Book TOC ...

Page 180: ...Sample Loader and Closed Sampler versions of the CELL DYN 3000 For convenience instructions for running samples in the Open Mode are included in each section Refer to Chapter 12 Sample Loader for a complete description of Sample Loader and to Appendix A Bar Codes for information on the use of bar code labels A description of the Data Station RUN MENU and the sub menus that are accessed from it is ...

Page 181: ...CUSTOMIZE REPORT CHANGE SAMPLER or TOGGLE AUTO ID The key label changes to TOGGLE AUTO ID when the cursor is positioned at the Auto ID location PRINT TICKET PRINT REPORT MAIN CLEAR ORIFICE WORK LIST SPECIMEN TYPE CUSTOMIZE REPORT CHANGE SAMPLER PRINT TICKET PRINT REPORT MAIN RUN Ready Dec 18 1992 Operator ID Sequence 09 43 734 0630 Next ID___________ Auto Patient___________ Sex M F DOB Dr_________...

Page 182: ...RBC replaces PATIENT when Resistant RBC is selected QC Filename replaces PATIENT when QC Specimen is selected The number of runs in the QC file and total file space are displayed to the right of the type as in the following example 31 120 Background replaces PATIENT when Background is selected ELEC BKGND replaces PATIENT when Electrical Background is selected 3 SEX M F These fields are used to ent...

Page 183: ... date and time Operator ID Identification of the current operator Sequence Automatically incremented as samples are run Selected Sampler mode Open Sampler or Closed Sampler The Center Section of the Data Station RUN Screen displays the results A list of the parameters and results is displayed on the left side Scatterplots and histograms are displayed on the right side The area between the paramete...

Page 184: ... Next ID _________Auto Patient_____________ Sex M F DOB Dr_____________ Param Limits 1 WBC 4 9 K uL NEU 3 0 60 0 N LYM 1 5 31 0 L BLAST MONO 0 3 6 2 M EOS 0 1 1 0 E BASO 0 1 1 8 B RBC M uL HGB 14 3 g dL HCT MCV fL MCH pg MCHC g dL RDW CLOG PLT K uL MPV fL WORK LIST SPECIMEN TYPE CUSTOMIZE REPORT CHANGE SAMPLER PRINT TICKET PRINT REPORT MAIN RUN Cleaning RBC orifice Dec 18 1992 Operator ID Sequence...

Page 185: ...sed from the RUN Screen while the instrument is continuing to process specimens the FLAGGING DIAGNOSTICS Screen does not update with the new specimen information The printout of the FLAGGING DIAGNOSTICS Screen obtained by pressing the PRINT REPORT soft key or the PRINT SCREEN key on the computer keyboard will be in the horizontal landscape format NOTE This information is provided for laboratory us...

Page 186: ...iated with the suspect population flag is displayed as a percentage of the total WBC value The region percentages displayed on the FLAGGING DIAGNOSTICS Screen are used as criteria for the suspect population flags displayed on the RUN Screen and the DISPLAY SPECIMEN Screen thus providing additional information as to potential severity of the flag The graphs located on the right side of the FLAGGING...

Page 187: ... changes to CLEAR FAULT whenever a system fault occurs e g Diluent Empty This key is used to clear the fault message and return the Analyzer to the Ready status after 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 Chapter 10 Troubleshooting of this manual Figure 5 27 Work List Screen CLE...

Page 188: ...tes between these two selections INSERT DELETE DELETE ALL PURGE COMPLETED WORK LIST SET UP PRINT WORK LIST RETURN The Work List is used to preassign sample identification display and print criteria for samples that will be run It is essentially a list of samples including the preassigned information that the operator intends to run on the instrument The Work List may be used with or without bar co...

Page 189: ...EX RESISTANT RBC RUN The function of each key is discussed in this section PATIENT QC SPECIMEN BACK GROUND ELECTRICL BACKGRND LATEX RESISTANT RBC RUN SPECIMEN TYPE Ready Dec 18 1992 Operator ID Sequence 09 55 734 0630 1 2 3 4 5 6 7 8 9 10 File Name Press QC SPECIMEN key to select QC FILE at cursor position Low Normal High low normal high Replicate FILE 8 FILE 9 FILE 10 11 13 0 0 0 0 0 0 0 0 Specim...

Page 190: ...Results from this run option are stored in the Data Log CLEAR ORIFICE WORK LIST SPECIMEN TYPE CUSTOMIZE REPORT CHANGE SAMPLER PRINT TICKET PRINT REPORT MAIN RUN Ready Dec 18 1992 Operator ID Sequence 09 51 734 0630 Next ID___________Auto Patient ___________ Sex M F DOB Dr ___________________ Param Set 1 Limits 3 WBC K uL NEU N LYM L MONO M EOS E BASO B RBC M uL HGB g dL HCT MCV fL MCH pg MCHC g dL...

Page 191: ...nd in the Data Log and are automatically excluded from the X B Analysis NOTE The selected QC file is identified on the same line line 2 as the Patient entry field It will also be identified in the Status Box after the sample has been run RUN Ready Dec 18 1992 Operator ID Sequence 09 53 734 0630 Type Low 11 120 Param Set 1 WBC K uL NEU N LYM L MONO M EOS E BASO B RBC M uL HGB g dL HCT MCV fL MCH pg...

Page 192: ...ified by the designation BACKGROUND in the data log and are automatically excluded from the X B analysis CLEAR ORIFICE WORK LIST SPECIMEN TYPE CUSTOMIZE REPORT CHANGE SAMPLER PRINT TICKET PRINT REPORT MAIN RUN Ready Dec 18 1992 Operator ID Sequence 09 51 734 0630 Type BACKGROUND Param Set 1 WBC K uL NEU N LYM L MONO M EOS E BASO B RBC M uL HGB g dL HCT MCV fL MCH pg MCHC g dL RDW PLT K uL MPV fL O...

Page 193: ... identified by the designation ELEC BKGND in the data log and are automatically excluded from the X B analysis The LATEX key is used to select the run mode for latex particles and display the RUN Screen for them This key is used by Abbott service personnel RUN Ready Dec 18 1992 Operator ID Sequence 09 52 734 0630 Type ELEC BKGND Param Set 1 WBC K uL NEU N LYM L MONO M EOS E BASO B RBC M uL HGB g d...

Page 194: ... RBC cycle reduces the number of these flags generated Normal samples run in the Resistant RBC Mode will have an increase in the false positive band flag rate NOTE Specimens with suspected fragile WBC populations should not be run in the Resistant RBC Mode The key is available only when the Open Mode is selected Figure 5 33 Run Screen for Resistant RBC RESISTANT RBC CLEAR ORIFICE WORK LIST SPECIME...

Page 195: ...ode currently selected to the other operating mode The Status Box displays the message SELECTING OPEN MODE or SELECTING CLOSED MODE When the cursor is positioned on the word AUTO at the end of the NEXT ID entry field the key label changes to TOGGLE AUTO ID This key enables word AUTO is highlighted or disables the auto increment feature Refer to the Sample Analysis section of this chapter for a dis...

Page 196: ...cols for handling samples collected in these anticoagulants Sample Stability Fresh whole blood samples are recommended The ICSH defines a fresh blood sample as one processed within four hours after collection The hemogram parameters RBC HGB HCT MCV MCH MCHC RDW PLT and MPV are stable 5 for up to 24 hours after collection The total WBC is stable 5 for up to 12 hours after collection The stability o...

Page 197: ...rfering Substances The CELL DYN 3000 has been designed to detect and flag samples that contain interfering substances The following list indicates the substances that may interfere with the listed parameters WBC NRBCs lytic resistant RBCs PLT clumps cryoglobulin and cryofibrinogen fragile WBCs RBC Elevated WBC count increased numbers of giant PLTs autoagglutination in vitro hemolysis HGB Elevated ...

Page 198: ...ple Loader automatically mixes the samples before aspiration However samples must be well mixed before they are placed in the Sample Loader racks Operator ID The operator should enter an Operator ID before running samples The operator ID is displayed on all screens and printed on the graphics report and the blank ticket report It is also retained in the QC Logs and the Data Log The operator ID may...

Page 199: ...changes from 99999 to 00000 Therefore leading zeros should precede the number to maximize the use of this feature 3 The remaining patient demographic information may be entered at the operator s discretion 4 The results are displayed and printed using Parameter set 1 and Patient Limit set 1 if no changes are made in these entry fields When the results are displayed but before the next sample is ru...

Page 200: ...he WBC and Differential and the WBC FLOW error message is displayed The message SAMPLING ERROR INCOMPLETE ASPIRATION is displayed on the Bulletin line if insufficient sample was detected during aspiration SAMPLING ERROR 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 preprinted ticket ...

Page 201: ... idle for four hours an automatic Shutdown cycle is initiated The instrument is placed in the STANDBY mode at the end of the automatic Shutdown cycle Power to the Printer may be left ON or OFF at the operator s discretion Refer to Chapter 11 Printer for complete instructions for printer operation Power to the Sample Loader may be left ON or OFF at the operator s discretion Refer to Chapter 12 Samp...

Page 202: ... Station RUN Screen 2 If the Status Box on the Data Station RUN Screen displays STANDBY or INITIALIZED press RUN or PRIME to initiate the automatic Start Up cycle 3 Be sure that all 10 racks are in the sample loader tray 5 on each side and the safety cover is in place 4 Turn the Sample Loader power switch ON When the Sample Loader initialization cycle is completed the indicator on the Sample Loade...

Page 203: ...ecommendations Patient controls should be handled according to the laboratory s protocol Open Mode QC Procedure 1 From the RUN Screen press SPECIMEN TYPE 2 Move the cursor to the desired QC file and press QC SPECIMEN 3 If necessary press CHANGE SAMPLER to select the Open mode 4 Run the control NOTE Refer to the Running Samples section following the QC procedures for complete instructions for runni...

Page 204: ... that the word Ready on the Analyzer status indicator panel is illuminated in green and the READY message is displayed in the Status Box on the Data Station RUN Screen 3 Place the labeled tubes in the Sample Loader end rack and load the rack in the Sample Loader tray 4 If necessary press RUN to display the RUN Screen 5 If necessary press CHANGE SAMPLER to select the Closed mode 6 Be sure that all ...

Page 205: ...HANGE SAMPLER to select the Closed mode 4 Place the controls in the Sample Loader end rack in the order in which they are to be run 5 Be sure that all 10 racks 5 on each side and the safety cover are in place and press the Start key on the Sample Loader NOTE If all QC data is going to the same file steps 6 10 may be skipped 6 After the first control is aspirated press the Pause key on the Sample L...

Page 206: ... sample aspiration probe is available only when this mode is selected Open Mode Procedure 1 If necessary from the RUN Screen press CHANGE SAMPLER to select the Open mode 2 Be sure that the word Ready is illuminated on the Analyzer status indicator panel and READY is displayed in the Status Box on the Data Station RUN Screen WARNING Potential Biohazard Follow established biosafety practices when pe...

Page 207: ...oader Start key indicator blinks when the Sample Loader is ready The probe is retracted when this mode is selected NOTE The last group of samples in a run should be placed in the Sample Loader rack known as the end rack which automatically signals the Analyzer to stop processing This rack has black labels on the top and a black bar on the left edge Closed Mode Procedure 1 Be sure that the word Rea...

Page 208: ...ple Loader automatically processes all the samples Processing stops when the end rack is finished Daily Shutdown It is not necessary to perform a Daily Shutdown procedure as the instrument automatically goes into a STANDBY mode if it has been idle for four hours If desired the operator may place the instrument in the STANDBY state by pressing SPECIAL PROTOCOLS followed by MORE followed by DAILY SH...

Page 209: ...he Status Box on the Data Station RUN Screen displays STANDBY or INITIALIZED press RUN or PRIME to initiate the automatic Start Up cycle 3 When the cycle is complete 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 ...

Page 210: ...d properly and again repeat the run If the results are still unacceptable run the other levels of control material If the results on all levels are unacceptable troubleshoot accordingly as directed in the Troubleshooting Guide 7 When the control results are acceptable patient samples may be analyzed Running Samples Open Mode Analysis The Open Sampler Mode aspirates the sample from an opened collec...

Page 211: ...t may be printed by pressing PRINT REPORT 8 Repeat this procedure for subsequent samples Closed Mode Analysis The Closed Sampler Mode on Closed Sampler CS instruments aspirates the sample from a closed collection tube that has been inserted in the Closed Sampler module CLOSED SAMPLER is displayed in the upper right corner of the Data Station RUN Screen when this mode is selected The probe is retra...

Page 212: ...e word Ready on the Analyzer status indicator panel is illuminated in green and the results are displayed on the Data Station RUN Screen 7 Repeat this procedure for subsequent samples Daily Shutdown It is not necessary to perform a Daily Shutdown procedure as the instrument automatically goes into a STANDBY state if it has been idle for four hours If desired the operator may place the instrument i...

Page 213: ...the entered information is displayed on the Data Station RUN Screen with the results stored in the Data Log The information is also printed on the report The Work List may be used with or without bar code labels on the tubes CAUTION If bar code labels are not used samples must be processed in the same order in which the information is listed on the Work List The following bar code symbologies may ...

Page 214: ...lternates between these two selections INSERT DELETE DELETE ALL PURGE COMPLETED WORK LIST SETUP PRINT WORK LIST RETURN Figure 5 34 Work List Screen WORK LIST WORK LIST OFF BAR CODE OFF INSERT DELETE DELETE ALL PURGE COMPLETED WORK LIST SET UP PRINT WORK LIST RETURN WORK LIST Ready Jul 07 1992 Operator ID Sequence 12 09 734 0330 1 2 3 4 5 6 4 DIGIT SPECIMEN SPECIMEN Work List ON BAR CODE ID NAME 12...

Page 215: ...of bar code was selected from the WORK LIST SETUP Screen and the Bar Code is ON the bar code number must be entered in this field 5 SPECIMEN ID A bar code number sample identification number or name may be entered in this field Up to 12 characters may be entered The sample is identified on the Data Station RUN Screen in the Data Log and on the printed report using the information entered in this f...

Page 216: ...ing error message was generated as the sample was processed either with or without the Sample Loader A mixing error message was generated as the sample was processed only when using the Sample Loader 10 RACK TUBE As samples are processed on the Sample Loader the Rack number and Tube number position of the tube in the rack are displayed in this field The operator cannot enter information in this fi...

Page 217: ...en information is deleted the line remains blank When the DELETE key is pressed the following soft key labels are displayed CONFIRM DELETION CANCEL DELETION These keys are used to confirm or cancel the Delete command The DELETE ALL key is used to delete all data from the Work List When the DELETE ALL key is pressed the following soft key labels are displayed CONFIRM DELETION CANCEL DELETION These ...

Page 218: ...digit bar code 2 Laboratory Specimen ID This field is used to specify the type of bar code that will be used when the Bar Code is ON If option 2 is selected the bar code number must be entered in the Specimen ID field 2 Specimen Name entry selected This field is used to specify whether a specimen name will be entered in the Work List TOGGLE RETURN WORK LIST SETUP Ready Dec 18 1992 Operator ID Sequ...

Page 219: ...ter Set see option 6 is used if no specification is made 6 Default Parameter Set 1 4 This field is used to specify the default preassigned Parameter Set that is automatically assigned to each sample unless otherwise indicated in the Work List The PRINT WORK LIST key is used to print the Work List The RETURN key is used to return to the Data Station RUN Screen Work List Setup Procedure 1 From the D...

Page 220: ...tion is made Parameter Set 1 will be used as the default Parameter Set Sample Analysis Using the Work List Sample Loader Instruments NOTE The Work List is active in the Closed Mode only on the Sample Loader version of the CELL DYN 3000 Using the Work List with Bar Codes The Sample Loader has a built in bar code reader that automatically reads a bar code label placed on the tube Refer to Appendix A...

Page 221: ...de number The Work List information is used to identify the sample on the Data Station RUN Screen and in the Data Log NOTE Special Q Labels are available to identify QC samples QC samples should not be entered in the Work List The Q label identifies the sample as a QC sample and the results are automatically transmitted to the appropriate file Sample Analysis Procedure 1 Follow the instructions in...

Page 222: ...order since the bar code label is used to identify them NOTE The last group of samples should be placed in an end rack so the Sample Loader will stop when all the samples have been processed 8 Install the Sample Loader safety cover 9 Press RETURN to return to the Data Station RUN Screen 10 Press SPECIMEN TYPE followed by PATIENT 11 If necessary press CHANGE SAMPLER to select the Closed Mode 12 Pre...

Page 223: ...played as RnTn CAUTION If a Sample Loader fault occurs that necessitates initialization of the Sample Loader remove all samples that have been processed before restarting the Sample Loader If these samples are not removed misidentification of the remaining samples will occur Sample Analysis Procedure 1 Follow the instructions in the Work List Set Up Procedure to configure the Work List 2 If necess...

Page 224: ...WORK LIST Screen displayed As the samples are processed the status of each sample is displayed in the STATUS field on the Work List Additional entries may be made to the Work List while processing takes place 12 The samples are automatically processed in the order they are placed in the racks The Sample Loader automatically stops when processing is finished if the last samples were placed in an en...

Page 225: ...er the Work List has been created The specimen ID number on the tube can be entered manually in the NEXT ID entry field on the Data Station RUN Screen Samples are identified in the Data Log by this number The Work List is accessed randomly as the samples are processed Sample identification is made by matching the Specimen ID number entered on the Data Station RUN Screen to the corresponding Work L...

Page 226: ...bsequent samples should be placed in the rack or on the mixer in the order in which the information is entered into the Work List 7 When all entries have been made press RETURN to return to the Data Station RUN Screen 8 Press SPECIMEN TYPE followed by PATIENT 9 If necessary press CHANGE SAMPLER to select the desired mode 10 Type the sample ID number in the NEXT ID entry field on the Data Station R...

Page 227: ...s chapter for instructions for running QC samples Sample Analysis Procedure 1 Follow the instructions in the Work List Set Up Procedure to configure the Work List 2 From the main WORK LIST Screen press WORK LIST ON to enable the Work List 3 If necessary press BAR CODE OFF to disable the bar code function 4 Type the appropriate sample identification information in the SPECIMEN ID and SPECIMEN NAME ...

Page 228: ...tered in the Work List NOTE If desired samples may be run with the WORK LIST Screen displayed Modifications to the Work List should be made only when the Data Station is in the READY state Running STAT Samples Turn the Work List OFF before running a STAT sample When the STAT sample run is completed turn the Work List ON and continue to process samples in the order in which they were entered in the...

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Page 230: ... 2629 2630 2631 2632 2633 2634 2635 2636 Seq Specimen ID 9100 R8 T5 R1 T3 BACK GROUND LOW LOW NORMAL HIGH LOW NORMAL HIGH PATIENT PATIENT PATIENT 6 7 6 7 6 7 3 9 0 0 2 7 7 7 8 0 18 8 2 7 7 4 18 1 12 9 12 5 12 9 12 7 4 4 4 4 4 4 2 1 1 8 4 6 4 8 10 5 1 7 4 3 10 3 8 5 8 3 8 6 8 4 1 6 2 0 1 7 1 1 0 5 2 0 2 0 5 7 0 5 2 1 5 4 3 3 3 0 3 0 3 3 0 4 0 2 0 3 0 3 0 3 0 7 0 8 1 7 0 2 0 6 1 7 0 7 0 7 0 8 0 6 0 ...

Page 231: ...next to a patient record See Figure 5 36 This key is displayed if the sequence number of the patient record is preceded by a B See Figure 5 36 The EDIT ID key is used to edit the Specimen ID from the DATA LOG Screen When the EDIT ID key is pressed the cursor moves into the SPECIMEN ID field and all key labels are blank Edits are saved by pressing the Enter key on the keyboard NOTE The EDIT ID key ...

Page 232: ...y is not displayed when the last specimen in the log is on the screen NOTE The FLAGGING DIAGNOSTICS Screen is displayed by pressing the Page Down key Spec ID R5 T1 Patient_____________ Sex M F DOB Dr_____________ Param Set 1 Limits 1 WBC 5 9 K uL NEU 3 2 54 0 N LYM 2 0 33 7 L MONO 0 6 9 8 M EOS 0 1 1 9 E BASO 0 0 0 5 B RBC 5 29 M uL HGB 16 0 g dL HCT 47 8 MCV 90 3 fL MCH 30 3 pg MCHC 33 6 g dL RDW...

Page 233: ... 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 record is displayed The CUSTOMIZE REPORT key is used to customize the DATA STATION RUN Screen display header and printout as described in the Set Up Instructions section of this chapter The TRA...

Page 234: ... B key is pressed the R is deleted the B is displayed and results are now included in the X B analysis DATA LOG SEARCH Ready Apr 30 1993 Operator ID Sequence 15 23 734 4659 4648HIGH 46 SL 4649HIGH 46 SL 4650HIGH 46 SL 4651LOW RD 43 SL 4652LOW RD 43 SL 4653LOW RD 43 SL 4654NORM RD 43 SL 4655NORM RD 43 SL 4656NORM RD 43 SL 4657HIGH RD 43 SL 4658HIGH RD 43 SL 4659HIGH RD 43 SL Seq Specimen ID 19 7 19...

Page 235: ... when the CUSTOMIZE DATA LOG key is pressed SELECT PARAMETER or PLACE PARAMETER The key alternates between these two selections STANDARD GROUPS or CUSTOM PLACEMENT The key alternates between these two selections CUSTOMIZE PRINTOUT RETURN WBC NEU LYM MONO EOS BASO RBC HGB HCT MCV MCH MCHC RDW PLT MPV UMT1 CNT1 WBC N L M E B WBC NEU LYM MONO EOS BASO RBC HGB HCT MCV MCH MCHC RDW PLT MPV PCT PDW N L ...

Page 236: ... the selected parameter is highlighted the label changes to PLACE PARAMETER and a CANCEL SELECTION key is displayed The PLACE PARAMETER key is used to display the parameter in the location indicated by the position of the cursor The CANCEL SELECTION key is used to cancel the selection and display the SELECT PARAMETER key Figure 5 40 Customize Display for Data Log Screen SELECT PARAMETER PLACE PARA...

Page 237: ... 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 40 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 placed in GROUP 4 When...

Page 238: ... DATA LOG Screen shows the order from left to right in which the indicated parameters will be printed 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 SELECT PARAMETER STANDARD SELECTION RETURN CUSTOMIZE PRINTOUT Ready Dec 18 1992...

Page 239: ...TA LOG Screen The TRANSMIT DATA key is used to transmit a record to a Laboratory Information System or on line computer When the TRANSMIT DATA 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 transmission Records may be transmitted singly or in batches as designated by the sequence number s The PRINT DAT...

Page 240: ...19A 04 CD3019A 05 CD3019A 06 CD3019A 07 CD3019A 08 CD3019A 09 CD3019A 10 low normal high high 7 8 9 10 8 2 8 1 8 2 8 4 8 2 8 1 8 1 8 3 2 8 7 7 18 4 18 8 5 5 5 5 7 9 6 5 5 6 5 3 5 5 5 6 5 5 5 5 5 4 5 4 2 0 4 8 10 0 10 2 3 1 3 0 5 3 2 2 0 5 1 5 0 7 1 8 1 7 1 7 1 4 1 7 0 4 1 8 2 5 2 7 1 8 1 9 2 0 3 6 1 2 0 8 1 0 0 7 0 7 0 7 0 8 0 8 0 2 0 8 3 2 2 7 0 5 0 4 0 4 0 5 0 1 0 1 0 1 0 1 0 1 0 1 0 1 0 1 0 1 0...

Page 241: ...631 2632 2633 2634 2635 2636 Seq Specimen ID 9100 R8 T5 R1 T3 BACK GROUND LOW LOW NORMAL HIGH LOW NORMAL HIGH PATIENT PATIENT PATIENT 6 7 6 7 6 7 3 9 0 0 2 7 7 7 8 0 18 8 2 7 7 4 18 1 12 9 12 5 12 9 12 7 4 4 4 4 4 4 2 1 1 8 4 6 4 8 10 5 1 7 4 3 10 3 8 5 8 3 8 6 8 4 1 6 2 0 1 7 1 1 0 5 2 0 2 0 5 7 0 5 2 1 5 4 3 3 3 0 3 0 3 3 0 4 0 2 0 3 0 3 0 3 0 7 0 8 1 7 0 2 0 6 1 7 0 7 0 7 0 8 0 6 0 1 0 1 0 1 0 ...

Page 242: ...the RBC PLT Count Time for an extended count EMPTY Inserts an empty column in the display Procedure Customize Data Log Display 1 From the main DATA LOG Screen press CUSTOMIZE DATA LOG to display the 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 WBC NEU LYM MONO EOS BASO RBC HGB HC...

Page 243: ... until all selections have been made 7 If desired press the Print Screen key on the keyboard to obtain a printout of the selected groups 8 Press RETURN to return to the DATA LOG Screen 9 The Data Log is displayed configured with the selected parameters Standard Groups The Data Log display may also be customized with predetermined groups Standard Groups of parameters using the STANDARD GROUPS key F...

Page 244: ...oups have been selected 6 If desired press the Print Screen key on the keyboard to obtain a printout of the configuration 7 Press RETURN to return to the DATA LOG Screen 8 The Data Log is displayed configured with the standard groups of parameters Figure 5 45 Customize Printout for Data Log Screen SELECT PARAMETER STANDARD SELECTION RETURN CUSTOMIZE PRINTOUT Ready Dec 18 1992 Operator ID Sequence ...

Page 245: ...rom the main DATA LOG Screen press CUSTOMIZE DATA LOG followed by CUSTOMIZE PRINTOUT 2 Use the Arrow keys on the keyboard to move the cursor to the desired parameter in the list displayed under the printout group 3 Press SELECT PARAMETER The selected parameter is highlighted and the cursor moves to the first position in the group NOTE The key label changes to PLACE PARAMETER and a CANCEL SELECTION...

Page 246: ... in the Data Log listing and pressing DISPLAY SPECIMEN The Status Box indicates DISPLAY SPECIMEN on results displayed or printed from the Data Log record See Figure 5 46 Figure 5 46 Display Specimen Screen PREVIOUS SPECIMEN NEXT SPECIMEN EDIT SPECIMEN CUSTOMIZE REPORT TRANSMIT SPECIMEN PRINT TICKET PRINT REPORT RETURN DISPLAY SPECIMEN Ready Dec 18 1992 Operator ID Sequence 13 11 734 0630 Spec ID 7...

Page 247: ... 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 requested record is available the screen displays the Data Log page containing it The cursor is located at the sequence number of the record 6 Press DISPLAY SPECIMEN to display the RUN Screen f...

Page 248: ...l 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 desired press PRINT REPORT to obtain a printout Spec ID Patient_____________ Sex M F DOB Dr_____________ Param Set 1 Limits 1 WBC 6 7 K uL NEU 3 8 56 7 N LYM 2 4 35 4 L MONO 0 4 6 4 M EOS 0 1 0 9 E BASO 0 0 0 6 B RBC 4 73 M uL H...

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Page 250: ...n 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 Search Go Back Book TOC ...

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Page 252: ...Calibration Requirements for Fresh Whole Blood 6 7 Calibration Overview 6 11 Auto Cal Overview 6 11 Introduction 6 11 Auto Cal Sample Capacity 6 11 Auto Cal Methodology 6 11 Calibration Requirements for Auto Cal 6 12 Calibration Menu 6 13 Manual Calibration Overview 6 24 Introduction 6 24 Guidelines 6 24 Mode To Mode Calibration Overview 6 25 Introduction 6 25 Auto Cal Mode to Mode Calibration 6 2...

Page 253: ...rameters Need Calibration 6 46 Calibration for All Parameters 6 48 Calibration for Individual Parameters 6 49 Completing Whole Blood Open Mode Calibration 6 49 Manual Calibration Open Mode 6 51 Procedure 6 51 Preparing for Manual Calibration 6 51 Determining the Open Mode Mean 6 51 Calibration Factor Calculations 6 52 Determining Which Parameters Need Calibration 6 53 Calibrating the Open Mode 6 5...

Page 254: ...n for All Parameters 6 77 Calibration for Individual Parameters 6 78 Completing Mode to Mode Calibration 6 78 Manual Mode To Mode Calibration 6 81 Procedure 6 81 Preparing for Manual Mode to Mode Calibration 6 81 Determining the Open Mode Mean 6 81 Determining the Closed Mode Mean 6 82 Difference Calculation 6 82 Determining Which Parameters Need Calibration 6 83 Calibration Factor Calculation 6 8...

Page 255: ...Table of Contents 4 CELL DYN 3000 System Operator s Manual 9140240E May 1995 Table of Contents Chapter 6 NOTES Search Go Back Book TOC ...

Page 256: ...e decision to recalibrate based on the performance of the CELL DYN 3000 in these quality control programs The programs include statistical computations and Westgard Rules for commercial or patient controls and monitoring of patient samples for the RBC parameters using Bull s moving average program X B The calibration of the CELL DYN 3000 should be confirmed on a regular basis according to the requ...

Page 257: ...th CELL DYN Calibrator is most efficiently performed by calibrating the Open mode The Closed mode is then calibrated to correlate with the Open mode using fresh whole blood samples Fresh Whole Blood Calibration with fresh whole blood is accomplished by performing multiple analyses of each sample by acceptable reference methodology and calculating the mean reference value for each parameter The sam...

Page 258: ...gram incorporated in the Data Station software Manual Calibration an alternative to Auto Cal The instrument s Open mode is calibrated with the calibration material of choice using the method of choice The Closed mode is then calibrated to correlate with fresh whole blood samples using the Mode to Mode Calibration method of choice The Calibration Overview section of this chapter contains an overvie...

Page 259: ...ksheets are provided at the end of each procedure to assist in determining which parameters require calibration For manual calibration worksheets may be used to assist in making the necessary calculations These worksheets may be duplicated as needed NOTE Always complete the Pre Calibration procedures before beginning any calibration Conventions Used in this Chapter A description of the Conventions...

Page 260: ...iate overview Auto Cal Calibration Manual Calibration Mode to Mode Calibration 2 Complete Pre Calibration Procedures 3 Open Mode Calibration Procedures Choose ONE Auto Cal Using Commercial Calibrator Auto Cal Using Fresh Whole Blood Manual Calibration 4 Closed Mode Calibration Procedures Choose ONE Auto Cal Mode to Mode Calibration for CELL DYN 3000SL Auto Cal Mode to Mode Calibration for CELL DYN...

Page 261: ...n procedure 2 All parameter values should be within the laboratory s normal range The following ranges are programmed for the reference values that may be entered in the Auto Cal program Results exceeding these limits cannot be entered WBC 2 0 25 0 K µL RBC 2 00 6 50 M µL HGB 4 0 24 0 g dL MCV 70 0 100 0 fL PLT 50 0 600 0 K µL 3 All cellular morphology must be normal 4 No known interfering substan...

Page 262: ... from the Reference Microhematocrit RBC Reference Values may be determined by using multiple counts from a certified hemocytometer or from a reliably calibrated hematology analyzer The MCV can be calculated from the Reference HCT and RBC Values NOTE Reference Microhematocrit Values may be determined by multiple analyses using the NCCLS Method for Packed Cell Volume PCV Use only plain non anticoagu...

Page 263: ...sed by in vitro deoxygenation 4 Mean values should be calculated for each parameter for each sample from the reference assay results These mean parameter values can then be entered in the Auto Cal program as reference values for each sample NOTE A worksheet is provided on the following page This worksheet may be used to assist with the calculation of the parameter reference means and may be duplic...

Page 264: ...______________________Parameter _______________________________________ Technologist ____________________________Method _________________________________________ ________________________________________________________________________________________ Sample ID Reference Assays Mean 1 2 3 4 5 6 7 8 9 10 Cumulative Parameter Mean Search Go Back Book TOC ...

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Page 266: ...en consecutive sample runs in the Open Mode up to five in the Closed Mode on up to ten different samples as indicated SL Sample Loader CS Closed Sampler Auto Cal Methodology The Auto Cal program automatically computes a calibration factor based on all acceptable data New factors are calculated using 1 00 as the reference NOTE Because the instrument uses 1 00 as the reference results generated in t...

Page 267: ...es In order to achieve an accurate calibration follow the appropriate requirements as listed below Calibrator Calibration The Calibrator should be cycled for a minimum of 5 consecutive runs and a maximum of 10 consecutive runs in the Open mode Whole Blood Calibration At least five different fresh normal Whole Blood Samples should be used Each sample must be cycled for a minimum of three consecutiv...

Page 268: ... OPEN SAMPLER or CLOSED SAMPLER Key label alternates between these two selections when the soft key is pressed PRINT MAIN Figure 6 1 Calibration Menu Screen Displaying Open Mode Calibration Factors CALIBRA TION ENTER FACTOR CALIBRATN LOG AUTO CALIBRATE CLOSED SAMPLER PRINT MAIN CALIBRATION Ready May 11 1992 Operator ID Sequence 10 30 734 4100 Open Sampler Current Whole Blood Factors Parameter Meth...

Page 269: ...for the mode selected see Figures 6 1 and 6 2 NOTE The key is labeled for the sampler mode that is NOT currently displayed The PRINT key is used to print the Current Whole Blood Factors displayed on the CALIBRATION MENU Screen ENTER FACTOR CALIBRATN LOG AUTO CALIBRATE OPEN SAMPLER PRINT MAIN CALIBRATION Ready May 11 1992 Operator ID Sequence 10 30 734 4100 Closed Sampler Current Whole Blood Factor...

Page 270: ...ft key labels are displayed RESTORE FACTORS RESET ALL TO 1 00 RETURN The RESTORE FACTORS key is used to restore the previous calibration factors This key is only active immediately after factors have been changed Figure 6 3 Enter Whole Blood Factor Screen MAIN ENTER FACTOR RESTORE FACTORS RESTORE FACTORS RESET ALL TO 1 00 RETURN ENTER WHOLE BLOOD FACTOR Ready May 11 1992 Operator ID Sequence 10 34...

Page 271: ...tween these two selections PRINT LOG RETURN The OPEN SAMPLER CLOSED SAMPLER key is used to display the calibration log for the selected mode NOTE The key is labeled for the sampler mode that is NOT currently displayed The PRINT LOG key is used to print the Calibration Log for the displayed mode The RETURN key is used to return to the CALIBRATION MENU Screen The AUTO CALIBRATE key is used to access...

Page 272: ...070 A 1 120 A 0 990 A 1 030 A 1 000 F Comments CALIBRATION TO CALIBRATOR LOT CD3012 INSTRUMENT INSTALLATION 08 02 92 11 41 734 1 010 A 1 130 E 1 120 A 1 010 E 1 130 E 1 000 F Comments RBC PLT APERTURE REPLACED WHOLE BLOOD CALIBRATR LATEX CHANGE SAMPLER RETURN AUTO CALIBRATION Ready May 11 1992 Operator ID Sequence 10 30 734 4100 Open Sampler Open sampler is selected To calibrate using the closed s...

Page 273: ...owing soft key labels are displayed EDIT REF VAL START AUTO CAL QUIT AUTO CAL CLEAR REF VALS PRINT SUMMARY RETURN CONFIRM SELECTION This key appears only if Auto Cal was last performed with a Calibrator CANCEL SELECTION This key appears only if Auto Cal was last performed with a Calibrator These keys are used to confirm or cancel the Whole Blood Auto Cal selection The bulletin line displays the me...

Page 274: ...Clear Reference Values command The PRINT SUMMARY key is used to print the entered reference values The RETURN key is used to return to the AUTO CALIBRATION Screen EDIT REF VAL START AUTO CAL QUIT AUTO CAL CLEAR REF VALS PRINT SUMMARY RETURN WHOLE BLOOD AUTO CAL Ready May 11 1992 Operator ID Sequence 10 01 734 4100 Open Sampler Enter reference value for each parameter to be calibrated up to 10 spec...

Page 275: ...UPT AUTO CAL QUIT AUTO CAL PRINT RETURN The INTERRUPT AUTO CAL key is used to interrupt pause the Auto Cal program The QUIT AUTO CAL key is used to exit from the Auto Cal program before it is completed When the QUIT AUTO CAL key is pressed the bulletin line displays the message ALL EXISTING DATA AND RESULTS WILL BE CLEARED The following soft key labels are displayed CONFIRM QUIT CANCEL QUIT These ...

Page 276: ...er reference value for each parameter to be calibrated up to 10 specimens Spec ID of runs WBC RBC HGB MCV PLT 1 to 10 2 0 25 0 2 00 6 50 4 0 24 0 70 0 100 50 600 CAL 01 3 7 30 4 24 12 9 90 0 244 CAL 02 3 INTERRUPT AUTO CAL QUIT AUTO CAL PRINT RETURN WHOLE BLOOD AUTO CAL Ready for Calibration May 11 1992 Operator ID Sequence 10 30 734 4100 Open Sampler RESULTS FOR SPECIMEN 1 Spec 1 Mean Factor Para...

Page 277: ... 6 10 This screen accesses the Auto Cal program that is used to calibrate the instrument with a commercial calibrator The following soft key labels are displayed EDIT REF VAL START AUTO CAL QUIT AUTO CAL CLEAR REF VALS PRINT SUMMARY RETURN OPEN SAMPLER REPEAT SPECIMEN REPEAT SPECIMEN INTERRUPT AUTO CAL QUIT AUTO CAL PRINT RETURN WHOLE BLOOD AUTO CAL Ready for Calibration May 11 1992 Operator ID Se...

Page 278: ...ON TO CLEAR PREVIOUS AUTO CAL REFERENCE VALUES The LATEX key is used to display the LATEX AUTO CAL Screen This screen accesses the Auto Cal program for MPV calibration with latex particles which is used by Abbott service personnel Figure 6 10 Calibrator Auto Cal Screen LATEX Open Sampler Enter reference value for each parameter to be calibrated up to 10 specimens Spec ID of runs WBC RBC HGB MCV PL...

Page 279: ... are then entered manually from the ENTER FACTOR Screen in the CALIBRATION MENU Worksheets are provided at the end of the procedure for use in making the calculations These worksheets may be duplicated as needed Guidelines The CELL DYN Calibrator must be warmed and mixed according to the directions given in the package insert and run 5 10 times If using whole blood samples A minimum of five differ...

Page 280: ...equire calibration For manual calibration worksheets may be used to assist in making the necessary calculations These worksheets may be duplicated as needed Auto Cal Mode to Mode Calibration After the Open mode has been calibrated or Open mode calibration is confirmed each sample is run one time in the Open mode For ease of identification samples should be run as patient samples The Open mode valu...

Page 281: ...the procedure If possible select samples that are less than four hours old All parameter values should be within the laboratory s normal range Closed Mode Calibration Confirmation An optional confirmatory step is included at the end of the Mode to Mode Calibration procedures which use whole blood samples After Closed mode calibration is completed instructions are given for rerunning the whole bloo...

Page 282: ...checklist included in this section may be duplicated as needed Calibration Guidelines 1 Verify that the Daily Weekly and Monthly scheduled maintenance as directed in Chapter 9 Maintenance of this manual is up to date before calibrating the instrument Instrument cleanliness is essential for accurate calibration Therefore each laboratory should perform any additional maintenance according to its req...

Page 283: ...at is pertinent to your instrument Suggested sections that you may wish to include in the logbook are Installation documentation Laboratory s operating procedure Quality control Calibration Maintenance Reagent lot number changes Troubleshooting Problem resolution Service calls Software upgrades This logbook should be stored near the instrument and be accessible to all operators and Abbott Service ...

Page 284: ...Diluent Lot ____________Exp Date _______ HGB Lyse Lot ____________ Exp Date _______ Sheath Reagent Lot ____________ Exp Date _______ 4 _______ If applicable verify that the calibrator has not reached the expiration date Lot ____________ Exp Date _______ 5 _______ After the maintenance has been completed verify that the Background Counts are within the acceptable limits Record the background counts...

Page 285: ... Loader by obtaining 15 mL of blood from the same donor Aliquot the blood into five 5 mL tubes that contain no anticoagulant Run each tube two times in succession If you have a Closed Sampler verify its precision by analyzing a fresh normal whole blood sample 10 times in succession Run the samples in an empty control file and record the CVs below or attach a file printout to this document PARAMETE...

Page 286: ...__________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ __________________________________________________________________________________...

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Page 288: ...d press PRINT to obtain a printout of the current whole blood factors displayed on the screen NOTE These calibration factors are retained in the Auto Cal Calibration Log until 10 entries have been made As each subsequent entry is made the oldest existing entry is deleted 4 Press AUTO CALIBRATE to select the AUTO CALIBRATION MENU 5 If necessary press CHANGE SAMPLER to select the Open mode 6 Press C...

Page 289: ... ANALYZER FOR CALIBRATION PLEASE WAIT on the bulletin line 2 If the data from the background counts is acceptable the displayed message changes to READY TO CALIBRATE PUSH CONTINUE AUTO CAL KEY START SAMPLES Proceed to step 7 3 If the data from the background counts is unacceptable the displayed message alternates between BACKGROUND COUNTS EXCEED LIMITS PERFORM MAINTENANCE TO CLEAR BACKGROUND and R...

Page 290: ...ghlighted and the bulletin line displays the message THIS RESULT IS OUTSIDE THE ALLOWED LIMITS REPEAT THIS SPECIMEN The run may be repeated at this time by pressing REPEAT SPECIMEN followed by CONFIRM REPEAT When the repeat function is used all results for the failed run are automatically deleted If the repeated run also fails the Reference Check the result s are highlighted and no calibration fac...

Page 291: ...leted a Calibration Factor is calculated and updated This factor is displayed in the column labeled SPEC N FACTOR The column labeled MEAN FACTOR N contains the average of the calibration factors for each parameter for all of the calibrators used in the calibration The number after mean factor indicates the number of Calibrators used to compute that mean factor NOTE If only one calibrator is used t...

Page 292: ...N RANGE WBC 1 5 RBC 1 0 HGB 1 0 MCV 1 0 PLT 3 0 If the results for all parameters are less than the values given above press QUIT AUTO CAL followed by CONFIRM QUIT The Auto Cal Calibration Log is available for comments only when a calibration factor is changed or reentered Therefore document the calibration in the COMMENTS line by accessing the log as follows From the CALIBRATION MENU Screen press...

Page 293: ...IT WBC 10 RBC 10 HGB 10 MCV 10 PLT 15 Check to see if any component that could affect the calibration was changed as this could cause the factor difference to exceed the above limits For example Shear valve RBC PLT transducer assembly WBC flow cell RBC PLT aperture Syringe s Hemoglobin flow cell If a component was changed calibrate the instrument as needed according to the directions in this proce...

Page 294: ...imits press ACCEPT MEANS The message ALL DATA AND RESULTS WILL GO AWAY is displayed on the bulletin line 2 Be certain that all desired printouts have been made 3 Press CONFIRM ACCEPT to save the mean factors and complete the Auto Cal procedure 4 The CALIBRATION LOG Screen is automatically displayed The log holds 10 entries The screen displays five entries Display the other five by pressing the Pag...

Page 295: ...se parameters that require calibration in the appropriate fields Refer to the printout made in step 1 of the Calibration Factor Calculation section Move the cursor to the desired position type the factor and press the Enter key on the keyboard to save the entry and advance the cursor 5 Press RETURN 6 When the CALIBRATION LOG Screen is displayed indicate the parameters that required calibration in ...

Page 296: ..._____________________________________________________________________ _______ Delete the sign of the Factor Difference before entering it on the chart Do not calibrate Call the Customer Support Center for assistance at 1 800 CELL DYN Auto Cal Calibration Criteria Factor Diff Validation Range Cal Not Required Cal Range Cal Required Cal Limit Do Not Cal Cal Y N WBC 1 5 1 5 but 10 10 RBC 1 0 1 0 but ...

Page 297: ...screen NOTE These calibration factors are retained in the Auto Cal Calibration Log until 10 entries have been made As each subsequent entry is made the oldest existing entry is deleted 4 Press AUTO CALIBRATE to select the AUTO CALIBRATION MENU 5 If necessary press CHANGE SAMPLER to select the Open mode 6 Press WHOLE BLOOD to select Whole Blood Auto Cal NOTE If necessary press CONFIRM SELECTION to ...

Page 298: ...played message changes to READY TO CALIBRATE PUSH CONTINUE AUTO CAL KEY START SAMPLES Proceed to step 7 3 If the data from the background counts is unacceptable the displayed message alternates between BACKGROUND COUNTS EXCEED LIMITS PERFORM MAINTENANCE TO CLEAR BACKGROUND and READY TO CALIBRATE PUSH CONTINUE AUTO CAL KEY START SAMPLES 4 Press QUIT AUTO CAL followed by CONFIRM QUIT to exit Auto Ca...

Page 299: ...PEAT SPECIMEN followed by CONFIRM REPEAT When the repeat function is used all results for the failed run are automatically deleted If the repeated run also fails the Reference Check the result s are highlighted and no calibration factor will be calculated for that parameter If all parameters fail the Reference Check results of that run are not displayed and the bulletin line displays the message A...

Page 300: ...ion factor currently in the instrument and the mean factor computed by the Auto Cal program When all runs of all whole blood samples have been completed the message NEW CAL FACTOR COMPUTED READY FOR ACCEPTANCE is displayed on the bulletin line 1 Press PREVIOUS SPECIMEN and or NEXT SPECIMEN to review and or print the results of all whole blood samples that were analyzed NOTE These results are only ...

Page 301: ...ailable for comments only when a calibration factor is changed or reentered Therefore document the calibration in the COMMENTS line by accessing the log as follows From the CALIBRATION MENU Screen press ENTER FACTOR Retype any existing Cal Factor Press the Enter key on the keyboard to save the entry and advance the cursor Press RETURN When the CALIBRATION LOG Screen is displayed indicate in the CO...

Page 302: ...BC flow cell RBC PLT aperture Syringe s Hemoglobin flow cell If a component was changed calibrate the instrument as needed according to the directions in this procedure If no components have been changed and the factor difference exceeds these limits DO NOT CALIBRATE CONFIRM THAT ALL PRE CALIBRATION PROCEDURES WERE COMPLETED AND THEN CALL THE CUSTOMER SUPPORT CENTER FOR ASSISTANCE AT 1 800 CELL DY...

Page 303: ...CCEPT to save the mean factors and complete the Auto Cal procedure 4 The CALIBRATION LOG Screen is automatically displayed The log holds 10 entries The screen displays five entries Display the other five by pressing the Page Up key on the keyboard When the log is full subsequent entries cause the oldest entry to be deleted and the remaining entries to move up one line so that the current factors a...

Page 304: ...s Refer to the printout made in step 2 of the Calibration Factor Calculation section Move the cursor to the desired position type the factor and press the Enter key on the keyboard to save the entry and advance the cursor 5 Press RETURN 6 When the CALIBRATION LOG Screen is displayed indicate the parameters that required calibration in the COMMENTS line Press the Enter key on the keyboard to save t...

Page 305: ..._____________________________________________________________________ _______ Delete the sign of the Factor Difference before entering it on the chart Do not calibrate Call the Customer Support Center for assistance at 1 800 CELL DYN Auto Cal Calibration Criteria Factor Diff Validation Range Cal Not Required Cal Range Cal Required Cal Limit Do Not Cal Cal Y N WBC 1 5 1 5 but 10 10 RBC 1 0 1 0 but ...

Page 306: ...T WHOLE BLOOD FACTORS displayed on the screen 4 Press RETURN followed by MAIN to return to the MAIN MENU Screen Determining the Open Mode Mean 1 From the MAIN MENU Screen press RUN 2 If necessary press CHANGE SAMPLER to select the Open mode 3 Press SPECIMEN TYPE 4 Use the Arrow keys on the keyboard to move the cursor to an empty QC File and type CD MEAN in the FILENAME field 5 Press the Enter key ...

Page 307: ...on Whole Blood Calibration 3 Referring to the New Open Mode Cal Factor from the previous step and the Current Open Mode Cal Factor from the printout use the appropriate chart on the worksheet to compute the Factor Difference as follows New Open Mode Factor Current Open Mode Factor x 100 New Open Mode Factor Factor Difference 4 Enter the factor difference for each parameter in the Manual Calibratio...

Page 308: ...comments only when a calibration factor is changed or reentered Therefore document the calibration in the COMMENTS line by accessing the log as follows From the CALIBRATION MENU Screen press ENTER FACTOR Retype any existing Cal Factor Press the Enter key on the keyboard to save the entry and advance the cursor Press RETURN When the CALIBRATION LOG Screen is displayed indicate in the COMMENTS line ...

Page 309: ...ransducer assembly WBC flow cell RBC PLT aperture Syringe s Hemoglobin flow cell If a component was changed calibrate the instrument as needed according to the directions in this procedure If no components have been changed and the factor difference exceeds these limits DO NOT CALIBRATE CONFIRM THAT ALL PRE CALIBRATION PROCEDURES WERE COMPLETED AND THEN CALL THE CUSTOMER SUPPORT CENTER FOR ASSISTA...

Page 310: ...ntries to move up one line so that the current factors are added 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 A Autocal F Factory E Enter Factor manual factor ent...

Page 311: ...All Factors To Three Decimal Places Current factor as printed in this manual calibration procedure If factor exceeds limits do not calibrate Check all calculations and call the Customer Support Center for assistance at 1 800 CELL DYN New Open Mode Calibration Factors Assay or Ref Mean x Current Open Mode Cal Factor New Open Mode Cal Factor Open Mode Assay Value or Ref Mean Open Mode Mean x Current...

Page 312: ... 1 800 CELL DYN Factor Difference New Open Mode Factor Current Open Mode Factor x 100 Diff New Open Mode Factor New Open Mode Factor Current Open Mode Factor New Open Mode Factor x 100 Diff WBC x 100 RBC x 100 HGB x 100 MCV x 100 PLT x 100 Manual Calibration Criteria Diff Validation Range Cal Not Required Cal Range Cal Required Cal Limit Do Not Cal Cal Y N WBC 1 5 1 5 but 10 10 RBC 1 0 1 0 but 10 ...

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Page 314: ...hem Single replications of each of 10 whole blood samples are required A printout of the Data Log for those sequence numbers can be used to enter the Reference Values and may be retained for documentation 1 From the MAIN MENU Screen press RUN 2 If necessary press CHANGE SAMPLER to select the Open mode 3 Press SPECIMEN TYPE then press PATIENT 4 Type the sample identification for the first sample in...

Page 315: ...e Values Enter the reference values for the whole blood samples as follows 1 Delete any existing values press CLEAR REF VALS followed by CONFIRM CLEAR 2 For each sample used type the appropriate information in the SPEC ID and OF RUNS fields Press the Enter key on the keyboard after each entry to save it and advance the cursor NOTE The OF RUNS entered indicates the number of times the sample will b...

Page 316: ... CALIBRATE PUSH CONTINUE AUTO CAL KEY START SAMPLES 4 Press QUIT AUTO CAL followed by CONFIRM QUIT to exit Auto Cal 5 Check the background results and troubleshoot out of range parameters 6 When the problem has been resolved return to the CALIBRATION MENU Screen and press AUTO CALIBRATE followed by WHOLE BLOOD and START AUTO CAL NOTE The information entered in steps 2 and 3 of the Entering the Ref...

Page 317: ...thin acceptable limits If the first run fails this internal reference check for any parameter the results are highlighted and will be excluded from the calculation of the calibration factor If all parameters fail the reference check results of that run are highlighted and excluded from the calculation of the calibration factor The bulletin line displays the message ABANDON CAL FOR SPECIMEN 1 RESUL...

Page 318: ...am When all runs of all whole blood samples have been completed the message NEW CAL FACTOR COMPUTED READY FOR ACCEPTANCE is displayed on the bulletin line 1 Press PREVIOUS SPECIMEN and or NEXT SPECIMEN to review and or print the results of all whole blood samples analyzed NOTE These results are only available for review and or printing before the ACCEPT MEANS key is pressed 2 Press PRINT to obtain...

Page 319: ...n above Press QUIT AUTO CAL followed by CONFIRM QUIT Document the calibration as follows The Auto Cal Calibration Log is available for comments only when a calibration factor is changed or reentered Therefore document the calibration in the COMMENTS line by accessing the log as follows From the CALIBRATION MENU Screen press ENTER FACTOR Retype an existing Cal Factor Press the Enter key on the keyb...

Page 320: ...LIMIT WBC 10 RBC 10 HGB 10 MCV 10 PLT 20 Check to see if any component that could affect the calibration was changed as this could cause the factor difference to exceed the above limits For example Shear valve RBC PLT transducer assembly WBC flow cell RBC PLT aperture Syringe s Hemoglobin flow cell If a component was changed calibrate the instrument as needed according to the directions in this pr...

Page 321: ...e limits press ACCEPT MEANS The message ALL DATA AND RESULTS WILL GO AWAY is displayed on the bulletin line 2 Be certain that all desired printouts have been made 3 Press CONFIRM ACCEPT to save the Mean Factors and complete the Auto Cal procedure 4 The CALIBRATION LOG Screen is automatically displayed The log holds 10 entries The screen displays five entries Display the other five by pressing the ...

Page 322: ...uted by Auto Cal for those parameters that require calibration in the appropriate fields Refer to the printout made in step 2 of the Calibration Factor Calculation section of this procedure Move the cursor to the desired position type the factor and press the Enter key on the keyboard to save the factor and advance the cursor 5 Press RETURN 6 When the CALIBRATION LOG Screen is displayed indicate t...

Page 323: ... System Operator s Manual 9140240E May 1995 Calibration Chapter 6 4 Confirm the calibration of the Closed Mode by running commercial controls as directed in the Post Calibration Procedures section Search Go Back Book TOC ...

Page 324: ...___________________________________________________________________ Delete the sign of the Factor Diff before entering it on the chart Do not calibrate Call the Customer Support Center for assistance at 1 800 CELL DYN Mode to Mode Calibration Criteria Factor Diff Validation Range Cal Not Required Cal Range Cal Required Cal Limit Do Not Cal Cal Y N WBC 1 75 1 75 but 10 10 RBC 1 25 1 25 but 10 10 HG...

Page 325: ...10 whole blood samples are required A printout of the Data Log for those sequence numbers can be used to enter the Reference Values and may be retained for documentation 1 From the MAIN MENU Screen press RUN 2 If necessary press CHANGE SAMPLER to select the Open mode 3 Press SPECIMEN TYPE then press PATIENT 4 Type the sample identification for the first sample in the NEXT ID field Press the Enter ...

Page 326: ...values for the whole blood samples as follows 1 Delete any existing values press CLEAR REF VALS followed by CONFIRM CLEAR 2 For each sample used type the appropriate information in the SPEC ID and OF RUNS fields Press the Enter key on the keyboard after each entry to save it and advance the cursor NOTE The OF RUNS entered indicates the number of times the sample will be consecutively cycled throug...

Page 327: ...AL KEY START SAMPLES 4 Press QUIT AUTO CAL followed by CONFIRM QUIT to exit Auto Cal 5 Check the background results and troubleshoot out of range parameters 6 When the problem has been resolved return to the CALIBRATION MENU Screen and press AUTO CALIBRATE followed by WHOLE BLOOD and START AUTO CAL NOTE The information entered in steps 2 and 3 of the Entering the Reference Values section is retain...

Page 328: ...ts of that run are not displayed and the bulletin line displays the message ABANDON CAL FOR SPECIMEN 1 RESULT NOT INCLUDED IN MEAN Repeat the specimen as directed above If all parameters on the repeated run also fail the Reference Check discard that sample and continue with the next calibration sample If desired a replacement sample may be added after the remaining samples have been run 9 Run each...

Page 329: ...am When all runs of all whole blood samples have been completed the message NEW CAL FACTOR COMPUTED READY FOR ACCEPTANCE is displayed on the bulletin line 1 Press PREVIOUS SPECIMEN and or NEXT SPECIMEN to review and or print the results of all whole blood samples analyzed NOTE These results are only available for review and or printing before the ACCEPT MEANS key is pressed 2 Press PRINT to obtain...

Page 330: ...n above Press QUIT AUTO CAL followed by CONFIRM QUIT Document the calibration as follows The Auto Cal Calibration Log is available for comments only when a calibration factor is changed or reentered Therefore document the calibration in the COMMENTS line by accessing the log as follows From the CALIBRATION MENU Screen press ENTER FACTOR Retype an existing Cal Factor Press the Enter key on the keyb...

Page 331: ...LIMIT WBC 10 RBC 10 HGB 10 MCV 10 PLT 20 Check to see if any component that could affect the calibration was changed as this could cause the factor difference to exceed the above limits For example Shear valve RBC PLT transducer assembly WBC flow cell RBC PLT aperture Syringe s Hemoglobin flow cell If a component was changed calibrate the instrument as needed according to the directions in this pr...

Page 332: ...ange limits press ACCEPT MEANS The message ALL DATA AND RESULTS WILL GO AWAY is displayed on the bulletin line 2 Be certain that all desired printouts have been made 3 Press CONFIRM ACCEPT to save the Mean Factors and complete the Auto Cal procedure 4 The CALIBRATION LOG Screen is automatically displayed The log holds 10 entries The screen displays five entries Display the other five by pressing t...

Page 333: ... 4 Type any mean factors computed by Auto Cal for those parameters that require calibration in the appropriate fields Refer to the printout made in step 2 of the Calibration Factor Calculation section of this procedure Move the cursor to the desired position type the factor and press the Enter key on the keyboard to save the factor and advance the cursor 5 Press RETURN 6 When the CALIBRATION LOG S...

Page 334: ...0E May 1995 Chapter 6 Calibration 3 Retain all necessary documentation in the instrument logbook 4 Confirm the calibration of the Closed mode by running commercial controls as directed in the Post Calibration Procedures section Search Go Back Book TOC ...

Page 335: ...________________________________________________________________ Delete the sign of the Factor Difference before entering it on the chart Do not calibrate Call the Customer Support Center for assistance at 1 800 CELL DYN Mode to Mode Calibration Criteria Factor Diff Validation Range Cal Not Required Cal Range Cal Required Cal Limit Do Not Cal Cal Y N WBC 1 75 1 75 but 10 10 RBC 1 25 1 25 but 10 10...

Page 336: ... SAMPLER to display the Closed Mode Calibration Factors 3 Press PRINT to obtain a printout of the CURRENT WHOLE BLOOD FACTORS displayed on the screen 4 Press RETURN followed by MAIN to return to the MAIN MENU Screen Determining the Open Mode Mean 1 From the MAIN MENU Screen press RUN 2 If necessary press CHANGE SAMPLER to select the Open mode 3 Press SPECIMEN TYPE 4 Use the arrow keys on the keybo...

Page 337: ...or at CLOSED MEAN file press VIEW QC LOG 9 Press PRINT QC LOG to obtain a printout of the data 10 Press RETURN followed by MAIN to return to the MAIN MENU Screen Difference Calculation 1 Use the mean value for each parameter from the OPEN MEAN and CLOSED MEAN file printouts for the calculations 2 Enter the information from step 1 on the Manual Mode to Mode Calibration worksheet and calculate the M...

Page 338: ...may be documented in the Auto Cal Calibration Log as follows The Auto Cal Calibration Log is available for comments only when a calibration factor is changed or reentered Therefore document the calibration in the COMMENTS line by accessing the log as follows From the CALIBRATION MENU Screen press ENTER FACTOR Retype any existing Cal Factor Press the Enter key on the keyboard to save the entry and ...

Page 339: ...hen recheck all calculations Check to see if any component was changed which could affect the calibration as this could cause the difference to exceed the above limits For example Shear valve RBC PLT transducer assembly WBC flow cell RBC PLT aperture Syringe s Hemoglobin flow cell If a component was changed calibrate the instrument as needed according to the directions in the following sections If...

Page 340: ...r for a given parameter falls outside the acceptable range there may be a computation error DO NOT CALIBRATE THAT PARAMETER Recheck all calculations and then call the Customer Support Center for assistance at 1 800 CELL DYN Calibrating the Closed Mode 1 From the MAIN MENU Screen press CALIBRATION 2 Press ENTER FACTOR to display the ENTER WHOLE BLOOD FACTOR Screen 3 Type the New Closed Mode Calibra...

Page 341: ...TS NOTE The letters in parentheses after each factor indicate the method of factor derivation A Autocal F Factory E Enter Factor manual factor entry 6 Type any comments in the COMMENTS field Press the Enter key on the keyboard to save the entry and advance the cursor NOTE Comments may be added to the Calibration Log only after a calibration factor is changed or reentered 7 If desired press PRINT L...

Page 342: ...e the sign of the Diff before entering it on the chart Do not calibrate Call the Customer Support Center for assistance at 1 800 CELL DYN Mode to Mode Calibration Difference Closed Mode Mean Open Mode Mean x 100 Diff Open Mode Mean Closed Mode Mean Open Mode Mean Open Mode Mean x 100 Diff WBC x 100 RBC x 100 HGB x 100 MCV x 100 PLT x 100 Mode to Mode Calibration Criteria Diff Validation Range Cal ...

Page 343: ... CELL DYN New Closed Mode Calibration Factors Open Mode Mean x Current Closed Mode Cal Factor New Closed Mode Cal Factor Closed Mode Mean Open Mode Mean Closed Mode Mean x Current ClosedMode Cal Factor New Closed Mode Cal Factor Range WBC x 0 700 1 300 RBC x 0 800 1 200 HGB x 0 700 1 300 MCV x 0 700 1 300 PLT x 0 700 1 300 Mode to Mode Post Calibration Difference Closed Mode Mean Open Mode Mean x ...

Page 344: ...Be certain you have recorded lot numbers where indicated 2 Call the Customer Support Center for assistance at 1 800 CELL DYN NOTE Inform the Customer Support Specialist 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 Back Up The current calibration factors...

Page 345: ...ATA STATION HARD DISK THE FOLLOWING COMMANDS ARE AVAILABLE GET ENTER COPIES SET UP INFORMATION FROM THE DATA STATION HARD DISK ONTO THE SET UP DISK PUT ENTER COPIES SET UP INFORMATION FROM THE SET UP DISK ONTO THE DATA STATION HARD DISK 7 Type GET 8 Press the Enter key on the keyboard The Set Up information is copied from the Data Station Hard Disk onto the Set Up Disk Previous Set Up information ...

Page 346: ...bration 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 Search Go Back Book TOC ...

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Page 348: ...3 Running Controls 7 13 Control Material 7 13 Mixing and Handling 7 13 Assay Verification 7 14 Westgard Rules 7 15 Introduction 7 15 CELL DYN 3000 Westgard Rules 7 15 Rule Violations 7 17 X B Analysis 7 18 Introduction 7 18 Lower Upper Acceptance Limits 7 18 Target Value 7 19 Action Limit 7 19 Establishing the Target Value 7 19 Interpreting X B Results 7 19 CELL DYN Controls 7 19 References 7 21 S...

Page 349: ...Table of Contents 2 CELL DYN 3000 System Operator s Manual 9140240E May 1995 Table of Contents Chapter 7 NOTES Search Go Back Book TOC ...

Page 350: ...analysis of the data in each file 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 The options may be used independently or in combination at the operator s request Each option is discussed in detail in the Quality Control Guide section of this chapter The first section of this chapter describes the...

Page 351: ...7 2 CELL DYN 3000 System Operator s Manual 9140240E May 1995 Quality Control Chapter 7 NOTES Search Go Back Book TOC ...

Page 352: ...e Figure 7 1 and the QC SETUP MENU Refer to the Set Up QC Files section of Chapter 5 Operating Instructions for an explanation of these keys as they will not be discussed in this section The following soft key labels are displayed when the QC LOGS key on the MAIN MENU Screen is pressed X B SETUP X B FILE VIEW QC LOG QC LIMITS SET UP QC FILE CUSTOMIZE DISPLAY CUSTOMIZE PRINTOUT MAIN These keys are ...

Page 353: ... and the lower and upper limits The date and time that each batch was completed are also displayed File Name Specimens 1 L0058A 76 2 N0058A 102 3 H0058A 65 4 FILE 4 0 5 FILE 5 0 6 FILE 6 0 7 FILE 7 0 8 FILE 8 0 9 FILE 9 0 10 FILE 10 0 X B SET UP X B FILE VIEW QC LOG QC LIMITS SETUP QC FILE CUSTOMIZE DISPLAY CUSTOMIZE PRINTOUT MAIN QC MENU Ready Mar 13 1993 Operator ID Sequence 15 51 734 0525 File ...

Page 354: ...33 43 10 26 92 15 45 14 91 91 30 90 33 37 01 18 93 15 58 5 91 44 30 74 33 62 10 30 92 10 52 15 92 74 31 12 33 37 01 21 93 11 13 6 90 64 30 76 34 59 11 02 92 15 46 16 89 29 30 01 33 48 02 01 93 11 13 7 90 64 30 72 33 82 11 16 92 10 58 17 89 07 30 03 33 82 02 02 93 14 23 8 90 62 29 39 32 33 11 17 92 09 50 18 89 08 30 04 33 82 02 04 93 14 23 9 90 61 29 56 32 59 12 07 92 10 58 19 89 66 30 12 33 70 03 ...

Page 355: ...ically printed The RETURN key is used to return to the QC MENU Screen The VIEW QC LOG key is used to display the QC log indicated by the position of the cursor Each QC log display shows the following information see Figure 7 4 MCV 94 50 90 00 85 50 SHOW DATA PRINT RETURN X B DISPLAY Ready Dec 22 1992 Operator ID Sequence 14 40 734 0630 PAGE UP DN FOR MORE DATA MCH 31 50 30 00 28 50 MCHC 35 70 34 0...

Page 356: ...0 83 5 13 2 215 8 3 Seq WBC RBC HGB MCV RDW PLT MPV Date Time Op 2475 7 4 4 40 13 5 86 2 15 6 248 9 1 O 03 10 93 09 09 734 2573 7 4 4 35 13 2 86 5 15 1 240 9 3 O 03 11 93 08 55 734 2574 7 4 4 39 13 3 86 6 15 5 236 8 9 O 03 11 93 08 57 734 2575 7 7 4 37 13 3 86 5 15 3 233 9 3 O 03 11 93 08 58 734 2613 7 7 4 42 13 2 86 0 15 6 244 9 2 O 03 12 93 09 12 734 2614 7 6 4 37 13 4 85 7 15 4 238 9 1 O 03 12 ...

Page 357: ...iration in the open mode I Incomplete aspiration in the closed mode K Metering fault clog or flow error M Mixing error on the Sample Loader B Blood detected in Sample Loader sample aspiration line 6 The statistics are displayed below the data as follows N the number of runs used in the calculation Mean the mean value for the number of runs used in the calculation Std Dev the standard deviation for...

Page 358: ...e all the points the user must scroll through the graph by pressing the NEXT 10 key When this key is pressed the last 20 points are shifted over by 10 and the next 10 points are included in the graph This gives the effect of scrolling through the data The graph title for example WBC indicates rule compliance or violation over the total set of samples not just the visible samples The LEVEY JENNINGS...

Page 359: ...INT key is used to print the Levey Jennings graphs When the PRINT key is pressed all of the graphs are automatically printed The RETURN key is used to return to the VIEW QC LOG Screen The REJECT SPECIMEN key is used to exclude the results for the specimen indicated by the cursor position GROUP 1 4 EOS 400 300 200 LEVEY JENNINGS MENU Ready WBC 7 00 6 40 5 80 GROUP 2 GROUP 3 GROUP 4 PREVIOUS 10 NEXT...

Page 360: ...tatistics are recomputed excluding those results Upper Limits 8 3 4 58 13 8 89 5 17 6 265 10 3 Lower Limits 7 1 4 22 13 0 83 5 13 2 215 8 3 Seq WBC RBC HGB MCV RDW PLT MPV Date Time Op 1838 7 6 4 37 13 1 85 9 15 6 221 8 8 O 03 02 93 09 50 734 1839 7 5 4 31 13 0 85 9 15 8 224 9 3 O 03 02 93 09 52 734 1840 7 7 4 33 13 1 85 8 15 1 232 8 8 O 03 02 93 09 52 734 1937 7 3 4 38 13 1 85 9 15 5 239 9 8 O 03...

Page 361: ...ile onto a floppy disk is not currently available Therefore the following keys mentioned in this manual should not be used at this time LAB ID SETUP LOAD FROM DISK and WRITE QC TO DISK The PRINT QC LOG key is used to print the entire QC log The RETURN key is used to return to the QC MENU Screen WRITE QC TO DISK PRINT QC LOG RETURN Search Go Back Book TOC ...

Page 362: ...ntrol checks on the CELL DYN 3000 These controls should be run After daily start up procedures are completed After a reagent lot number change After calibration confirmatory step After maintenance a service call or component replacement In accordance with the laboratory s quality control protocol According to regulatory requirements The CELL DYN controls may be run in any mode of operation open mo...

Page 363: ...ay for five days The mean of the ten runs is used to confirm the assay value A control file is set up for the new lot number to easily establish the mean If desired this same control file can then be used to run the control for the remainder of the dating period Creating another file is not required The expected ranges published by manufacturers are generally too broad for effective quality contro...

Page 364: ...of both types of error Westgard recommended a multi rule approach to evaluating quality control results 2 This approach has long been used in the chemistry laboratory3 but is new in the hematology laboratory A set of modified Westgard rules may be used to monitor quality control results on the CELL DYN 3000 CELL DYN 3000 Westgard Rules The modified Westgard Rules Westgard s nomenclature is given i...

Page 365: ...the LEVEY JENNINGS MENU Screens See Figure 7 7 Six plus signs indicate that all six rules are selected in order from left to right A minus sign is displayed if a rule is not selected Figure 7 7 Levey Jennings Menu Screen Showing Westgard Rule Violations The number of the rule that was violated is displayed in place of the plus sign Figure 7 7 shows examples of the plus and minus signs and rule vio...

Page 366: ...n the instrument is in control If any control result exceeds the 2SD limits check to see if it exceeds the 3SD limits If a result exceeds 3SD there are two possibilities There is either an instrument problem or a problem with the particular level of control Therefore if a result exceeds 3SD run another bottle of that control If the problem persists then additional investigation is required Check t...

Page 367: ...n of those red cells Consequently the average red cell indices of a given patient population will vary no more than 0 5 percent from day to day and even year to year providing the population does not change 5 The X B algorithm provides a means of utilizing this information for quality control on the CELL DYN 3000 The X B algorithm analyzes the indices on the patient samples run through the instrum...

Page 368: ...alized patient populations e g pediatric hospitals or tumor centers may need to verify these values due to abnormal patient populations Target values may be verified by evaluating approximately 500 samples and comparing the X B means for those samples to the entered target values The CV on 500 samples for each index should be 1 5 Dr Bull s study mentioned in the previous paragraph found CVs from 0...

Page 369: ...7 20 CELL DYN 3000 System Operator s Manual 9140240E May 1995 Quality Control Chapter 7 NOTES Search Go Back Book TOC ...

Page 370: ... 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 Hay KL Are red...

Page 371: ...7 22 CELL DYN 3000 System Operator s Manual 9140240E May 1995 Quality Control Chapter 7 NOTES Search Go Back Book TOC ...

Page 372: ...itations 8 1 Location Requirements 8 1 Electrical Safety Precautions 8 2 Mechanical Safety Precautions 8 3 Chemical Safety Precautions 8 3 Infection Control 8 3 Decontamination Procedures 8 4 Blood Samples 8 4 Spills 8 4 Reagent Storage and Handling 8 5 Laser Precautions 8 5 Printer Precautions 8 5 Sample Loader Precautions 8 6 Search Go Back Book TOC ...

Page 373: ...Table of Contents 2 CELL DYN 3000 System Operator s Manual 9140240E May 1995 Table of Contents Chapter 8 NOTES Search Go Back Book TOC ...

Page 374: ... Chapter 9 Maintenance of this manual All service and repair must be performed by authorized Abbott representatives Location Requirements An authorized Abbott representative must install the instrument Place the CELL DYN 3000 Analyzer and Data Station on a hard level surface The location should have nonporous non absorbing work surfaces and flooring which can be easily cleaned and disinfected usin...

Page 375: ...he event that the printer is placed on top of the Data Station Do not place the printer on top of the Analyzer Refer to Chapter 11 Printer for more details Electrical Safety Precautions Do not disconnect any electrical connection while the power is ON For continued protection from electric shock use only approved power cords such as those supplied and connect power cords only to properly grounded ...

Page 376: ...ard Communication Standard 29 CFR Part 1910 1200 Infection Control Consider all blood specimens potentially infectious Wear disposable gloves while handling test samples Do not smoke eat or drink in areas where test samples are handled Do not pipette by mouth Consider all clinical specimens and controls calibrators etc that contain human blood or serum as potentially infectious Use established goo...

Page 377: ... Procedures section of Chapter 9 Maintenance Blood Samples Decontaminate and dispose of all specimens and potentially contaminated materials in accordance with local state and federal regulations Waste liquid is a possible source of biological and chemical hazard Handle with extreme care during the disposal process Refer to the Sample Collection and Handling section in Chapter 5 Operating Instruct...

Page 378: ...nt for the first time make sure each reagent line is connected to the appropriate inlet and reagent container Make sure the waste line is connected to the appropriate outlet and routed to a suitable waste container or drain If the waste is routed to a waste container make sure the waste sensor is properly connected If the waste is routed to a drain make sure a dummy plug is inserted in the waste s...

Page 379: ...ed washing system that operates at elevated temperatures as this may damage the racks Clean the Sample Loader needles prior to touching them by sampling with a tube containing enzymatic cleaner followed by an Auto Clean procedure Wear gloves lab coat and suitable eye protection and follow other biosafety practices as specified in the OSHA Bloodborne Pathogen Rule or other equivalent biosafety proc...

Page 380: ...uto Clean 9 13 Procedure 9 14 Sample Loader Aspiration Needle 9 15 Procedure 9 15 Closed Sampler Aspiration Needle 9 16 Procedure 9 16 Weekly 9 17 Weekly Maintenance Procedures 9 17 Shear Valve 9 17 Procedure 9 18 Aspiration Peristaltic Pump Tubing 9 20 Procedure 9 22 Sample Loader Tray Racks and Safety Cover 9 22 Procedure 9 23 Monthly 9 25 Monthly Maintenance Procedures 9 25 Reagent Syringes 9 2...

Page 381: ...T Aperture Plate 9 35 Procedure 9 36 Hemoglobin Flow Cell Manual Cleaning Procedure 9 39 Procedure 9 40 Vacuum Accumulator Cleaning Procedure 9 41 Procedure 9 41 Special Procedures 9 43 Closed Sampler Tube Retainer Adjustment 9 43 Procedure 9 43 Preparation for Inactivity or Shipping 9 44 Procedure 9 44 Repackaging for Shipment 9 46 Search Go Back Book TOC ...

Page 382: ... if it has been idle for four hours after the last cycle is completed The operator is encouraged to routinely perform the required maintenance in order to ensure optimum performance This chapter 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 preventive maintenan...

Page 383: ...e workload schedule the operating environment and the patient population that is analyzed Each laboratory must assess its own situation and modify these recommended intervals as necessary Overdue maintenance is usually indicated by an increase in imprecision of one or more of the directly measured parameters This increase is due to carryover or dilution sampling inconsistencies If this occurs the ...

Page 384: ... Replace the aspiration peristaltic pump tubing 3 Clean the Sample Loader tray racks and safety cover Monthly 1 Clean the syringes RBC Diluent syringe HGB Diluent syringe HGB Lyse syringe WBC Sheath syringe WBC Metering syringe 2 Replace the WBC transfer peristaltic pump tubing 3 Clean the Analyzer and Data Station air filters 4 Perform the Extended Auto Clean procedure As Required Maintenance for...

Page 385: ...troubleshooting procedures Wear gloves lab coat and suitable eye protection Refer to Chapter 8 Precautions Limitations and Hazards for additional information CAUTION Use powder free gloves when performing the maintenance procedure to avoid contaminating the instrument Analyzer Flow Panel Components Diagram A diagram of the Analyzer flow panel components has been included on the next page This diag...

Page 386: ...Metering Assembly Vacuum Accumulator Drain Lines Hydrophobic Filters Waste Chamber 2 Sample Aspiration Peristaltic Pump Shear Valve Assembly Status Indicator Panel READY BUSY FAULT Closed Sampler Module WBC Metering Syringe contains Sheath reagent WBC Sheath Syringe contains Sheath reagent HGB Lyse Syringe contains HGB Lyse HGB Diluent Syringe contains Diluent RBC Diluent Syringe contains Diluent ...

Page 387: ...9 6 CELL DYN 3000 System Operator s Manual 9140240E May 1995 Maintenance Chapter 9 NOTES Search Go Back Book TOC ...

Page 388: ...layed EMPTY RBC or FILL RBC Key label alternates between these two selections EMPTY REAG RESV or FILL REAG RESV Key label alternates between these two selections EMPTY WBC or FLUSH SHEATH Key label alternates between these two selections CLEAN SHEAR VAL or RESTORE SHEAR VAL Key label alternates between these two selections DISABLE ANALYZER or ENABLE ANALYZER Key label alternates between these two ...

Page 389: ...to FILL RBC The display in the Status Box reads Not Ready See SPECIAL When the FILL RBC key is pressed the transducer assembly is refilled with reagent The EMPTY REAG RESV key is used to drain the reagent reservoirs located on the left side panel of the Analyzer After the reagent reservoirs are drained the FILL REAG RESV key is displayed and the status box reads Not Ready See SPECIAL When the FILL...

Page 390: ...x reads Not Ready See SPECIAL When the RESTORE SHEAR VAL key is pressed the shear valve rotates to distribute the shear valve lubricant and then rotates back to its operational position The DISABLE ANALYZER key is used to prevent the Analyzer from cycling while certain maintenance procedures are performed When the Analyzer is disabled the key label changes to ENABLE ANALYZER The display in the Sta...

Page 391: ... transducer assembly and all of the associated fluidics are automatically cleaned and rinsed during the procedure When the AUTO CLEAN key is pressed the screen displays the message shown in Figure 9 5 Special Protocols Auto Clean Screen The following soft key labels are displayed START CANCEL These keys are used to start or cancel the Auto Clean procedure FLUSH SHEATH AUTO CLEAN DAILY SHUTDOWN PRE...

Page 392: ...e the Analyzer is in STANDBY to preserve the integrity of the tubing The PREPARE SHIPPING key is used to prepare the Analyzer for shipment or a period of inactivity The CLEAN NEEDLE key is used to clean the needle s in either of the closed modes CS or SL of operation When the key is pressed the needle is forcefully rinsed with Diluent The EXTEND AUTOCLEAN key is used to initiate the Extended Auto ...

Page 393: ...owing screen is displayed Figure 9 4 Special Protocols Process Complete Screen MORE Special Protocol Cycle has completed Run 5 Background Counts Confirm that background results are acceptable before running samples EMPTY RBC EMPTY REAG RESV EMPTY WBC CLEAN SHEAR VAL DISABLE ANALYZER MORE MAIN SPECIAL PROTOCOLS Initialized Sep 14 1994 Operator ID Sequence 16 20 JC 3288 Search Go Back Book TOC ...

Page 394: ...rocedure to gently scrub and remove any fibrin or debris within the system The Auto Clean procedure see Figure 9 5 takes approximately 11 minutes Figure 9 5 Special Protocols Auto Clean Screen WARNING Potential Biohazard Follow established biosafety practices when performing maintenance service or troubleshooting procedures Wear gloves lab coat and suitable eye protection Refer to Chapter 8 Precau...

Page 395: ...m water and a few drops of CELL DYN Enzymatic Cleaner 3 From the MAIN MENU Screen Press SPECIAL PROTOCOLS followed by MORE to access the Auto Clean function 4 Press AUTO CLEAN Instructions for performing the procedure are given on the screen See Figure 9 5 5 Dispense approximately 1 5 mL of enzymatic cleaner undiluted into a clean container and hold the container under the open sampler probe NOTE ...

Page 396: ...eaner undiluted into one of the Vacutainer tubes 2 Aliquot approximately 2 mL of diluent into each of the other two Vacutainer tubes 3 If necessary from the Data Station RUN Screen press CLOSED SAMPLER to select the closed mode 4 Press SPECIMEN TYPE followed by BACKGROUND 5 Place the enzymatic cleaner tube followed by the two diluent tubes in a Sample Loader end rack 6 Position the rack in the Sam...

Page 397: ...uitable eye protection Procedure 1 Aliquot approximately 2 mL of enzymatic cleaner undiluted into one of the Vacutainer tubes 2 Aliquot approximately 2 mL of diluent into each of the other two Vacutainer tubes 3 If necessary from the Data Station RUN Screen press CLOSED SAMPLER to select the closed mode 4 Press SPECIMEN TYPE followed by BACKGROUND 5 Aspirate the enzymatic cleaner 6 Aspirate the Di...

Page 398: ...he instrument Shear Valve Regular cleaning and lubrication of the shear valve is required for optimal performance Any reagent or blood residue may cause the valve to leak or function improperly The shear valve assembly is depicted in Figure 9 6 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 th...

Page 399: ...ion Procedure 1 Remove the upper front cover to gain access to the shear valve 2 From the Data Station MAIN MENU press SPECIAL PROTOCOLS followed by CLEAN SHEAR VAL This prepares the shear valve for removal and puts the Analyzer into a NOT READY mode 3 Turn the shear valve retaining screw counterclockwise until it can be removed Retaining Screw Front Section Center Section Rear Section Lock Notch ...

Page 400: ...ropped 6 Place the rear section with its attached tubes on a clean wipe in the shear valve compartment 7 Rotate the center and front sections in opposite directions to separate them 8 Place the center section in a container of warm water and allow it to soak for the remainder of the cleaning procedure CAUTION Do not soak the center section in bleach as it may damage the ceramic 9 Place the front s...

Page 401: ...ing guide and push it back until it touches the rear section 20 Align the lock notch of the front section with the mounting guide Carefully slide it back until it touches the center section 21 Firmly hold the three valve sections in place and replace the shear valve retaining screw Turn the screw clockwise until it stops 22 Press RESTORE SHEAR VAL The valve automatically rotates several times to d...

Page 402: ... service or troubleshooting procedures Wear gloves lab coat and suitable eye protection Refer to Chapter 8 Precautions Limitations and Hazards for additional information CAUTION Use powder free gloves when performing the maintenance procedure to avoid contaminating the instrument NOTE The sample aspiration pump tubing has a smaller diameter than the WBC transfer pump tubing and is identified by th...

Page 403: ...g in the center of the rollers 8 Replace the upper front cover 9 Press ENABLE ANALYZER 10 Press MAIN to return to the MAIN MENU Screen 11 Verify that the background counts are acceptable by running 5 background counts before running controls If the background counts or controls are unacceptable refer to Chapter 10 Troubleshooting Sample Loader Tray Racks and Safety Cover The Sample Loader tray rac...

Page 404: ...on as the labels will come off Use cotton swabs to dislodge any debris 3 Verify rack labels are intact and undamaged NOTE Do not wash the racks in an automated dishwasher that operates at high temperatures because the heat may damage the racks 4 Rinse the racks with warm water and dry thoroughly with lint free wipes or towels 5 Wipe the stainless steel tray area with a lint free wipe moistened wit...

Page 405: ...9 24 CELL DYN 3000 System Operator s Manual 9140240E May 1995 Maintenance Chapter 9 NOTES Search Go Back Book TOC ...

Page 406: ...n the correct position Replace each syringe after it is cleaned and then remove the next one to be cleaned The WBC syringe assembly is depicted in Figure 9 8 Figure 9 8 WBC Syringe Assembly Materials Required 1 A large container filled with approximately 500 mL of warm water 2 Lint free wipes and gauze 3 Distilled water 4 Small container of each reagent to refill the clean syringes 5 Gloves lab co...

Page 407: ...gent 3 Loosen the syringe holder plate thumbscrew and rotate the syringe holder plate into a vertical position 4 Lift the syringe out of the holder Note the liquid level in the syringe so that it can be refilled after cleaning to approximately this same level 5 Grasp the plastic luer lock fitting at the tip of the syringe which attaches it to the tubing Carefully turn the syringe counterclockwise ...

Page 408: ...l to not overtighten the fitting or crimp the associated tubing 12 Insert the syringe into the V block holder and the end of the plunger into its slot in the pedestal assembly Carefully check the position of the flange at the base of the barrel The flange must be inserted into the narrow space at the base of the V block in order to hold the syringe securely in place during the cycle Refer to Figur...

Page 409: ...equency of replacement depends on instrument use in each laboratory Abbott recommends changing the WBC pump tubing monthly A peristaltic pump is depicted in the following figure Figure 9 9 WBC Transfer Peristaltic Pump Materials Required 1 WBC transfer pump tubing 2 Gloves lab coat and suitable eye protection WARNING Potential Biohazard Follow established biosafety practices when performing mainte...

Page 410: ...e plastic fittings 6 Connect the new tubing to the plastic fittings 7 Place the collars on the ends of the tubing into the metal guides Hold the release lever open and push the tubing underneath the pump rollers Position the tubing in the center of the rollers 8 Replace the upper front cover 9 Press ENABLE ANALYZER 10 Press MAIN to return to the MAIN MENU Screen 11 Verify that the background count...

Page 411: ...filter handle and slide the holder forward to remove it The lower filter is removed the same way 3 Rinse the filters with warm water from the inside to the outside to remove the dust Blot each filter with lint free tissues or towels to dry the filters completely before replacing them or Clean the filters by vacuuming them 4 Insert the upper filter holder into its slot Slide it back into place unti...

Page 412: ... the bracket that holds the fan Pull on the top corners to remove the frame Figure 9 11 Data Station Rear Panel 3 Rinse the filter with warm water from the inside to the outside to remove the dust Blot the filter with lint free tissues or towels to completely dry it before replacement or Clean the filter by vacuuming it 4 Place the filter over the fan 5 Place the frame over the filter and press to...

Page 413: ...pproximately 2 5 hours When the 2 5 hours are completed the instrument is in the STANDBY mode The procedure may be canceled by pressing the CANCEL key which is displayed after 38 minutes Materials Required 1 CELL DYN Enzymatic Cleaner brought to room temperature 2 Clean test tube or container 3 Lint free wipes or gauze 4 Warm water 5 Gloves lab coat and suitable eye protection WARNING Potential Bi...

Page 414: ...n function 5 Press EXTEND AUTOCLEAN Instructions for performing the procedure are given on the screen Figure 9 12 6 Dispense approximately 1 5 mL of enzymatic cleaner undiluted into a clean container and hold the container under the open sample aspiration probe NOTE Do not press the touch plate The Extended Auto Clean procedure is initiated only by the START key START CANCEL SPECIAL PROTOCOLS Read...

Page 415: ...NCEL key is pressed a rinse cycle is initiated which prepares the instrument for sample processing When the rinse cycle finishes press MAIN to return to the MAIN MENU Screen 9 At the end of the 2 5 hours the instrument automatically goes into the STANDBY mode Press RUN to bring the Analyzer out of STANDBY and prepare it for sample processing 10 Verify that the background counts are acceptable by r...

Page 416: ...etermine the frequency of cleaning needed NOTE The count time is displayed on the RUN Screen to the right of the MPV result The count time is also displayed on the RAW DATA SUMMARY Screen accessible from the DIAGNOSTICS MENU The RBC PLT aperture should be cleaned if the count time differs from the baseline value by more than 0 4 seconds or if there are frequent RBC CLOG messages The RBC PLT apertu...

Page 417: ...ion WARNING Potential Biohazard Follow established biosafety practices when performing maintenance service or troubleshooting procedures Wear gloves lab coat and suitable eye protection Refer to Chapter 8 Precautions Limitations and Hazards for additional information CAUTION Use powder free gloves when performing the maintenance procedure to avoid contaminating the instrument Procedure 1 Remove th...

Page 418: ...he red jewel embedded in center of the plate Rotate the aperture brush in the opening to ensure the cleaning solution penetrates it completely Allow the plate to soak for five minutes DO NOT soak the plate longer than five minutes as prolonged soaking may damage the aperture plate CAUTION DO NOT use anything but the aperture brush provided in the accessory kit to clean the aperture Using other imp...

Page 419: ...ecurely hold the plate in place See Figure 9 14 11 Press FILL RBC to refill the transducer assembly and the associated tubing 12 Replace the upper and lower front covers 13 Press MAIN followed by RUN to return to the RUN Screen 14 Verify that the background counts are acceptable by running 5 background counts 15 When an acceptable background count has been obtained record the count time in the ins...

Page 420: ... cell the HGB mixing chamber and Solenoid 14 are depicted in Figure 9 15 Figure 9 15 The HGB Mixing Chamber HGB Flow Cell and Solenoid 14 Materials Required 1 Cleaning solution Make a 25 bleach solution by adding 5 mL of bleach to 15 mL of deionized water 2 10 20 mL syringe with a piece of tubing attached 3 Gloves lab coat and suitable eye protection WARNING Potential Biohazard Follow established ...

Page 421: ...6 Fill the syringe with the cleaning solution and connect it to the tubing Dispense 10 mL of the cleaning solution into the mixing chamber 7 Remove the syringe and reconnect the tubing 8 Manually open Solenoid 14 and allow two thirds of the bleach solution to drain into the HGB flow cell 9 Close Solenoid 14 to hold the bleach solution in the flow cell 10 Allow the bleach solution to remain in the ...

Page 422: ... from the Analyzer to gain access to the flow panel 3 Locate the two vacuum accumulator drain lines on the bottom left hand corner of the flow panel Refer to Figure 9 1 4 Place the empty receptacle under one of the lines while removing the white cap If the fluid does not drain freely attach the syringe to the line 5 Pull back on the plunger to aspirate any liquid from the accumulator Discard the l...

Page 423: ...he other drain line 10 Replace the upper and lower front covers on the Analyzer 11 Power ON the Analyzer and then power ON the Data Station 12 Verify that the background counts are acceptable by running 5 background counts before running controls If background counts or controls are unacceptable refer to Chapter 10 Troubleshooting Search Go Back Book TOC ...

Page 424: ...eeze the release levers on the sides of the tube retainer between the thumb and forefinger to loosen it and slide the clamp up 2 Insert the Vacutainer tube cap down into the cap piercer well 3 Slide the clamp down to hold the tube snugly in place 4 Release the levers when the tube retainer has been properly positioned 5 Check the height adjustment with several Vacutainer tubes to be certain that i...

Page 425: ...ection this is stored in the disk storage container located on the Analyzer flow panel to the right of the WBC flow cell access cover Four plastic bags to hold the reagent inlet and waste outlet tubes 3 Gloves lab coat and suitable eye protection WARNING Potential Biohazard Follow established biosafety practices when performing maintenance service or troubleshooting procedures Wear gloves lab coat...

Page 426: ... to Figure 1 6 for the location of these normally closed valves 2 Replace peristaltic pump tubing into the sample aspiration pump and the WBC transfer pump 3 Replace reagent lines into the appropriate reagent cubitainers 4 Power ON the Analyzer and then the Data Station 5 When Initialized press RUN to prime 6 Verify that the background counts are acceptable by running 5 background counts before ru...

Page 427: ...to Chapter 8 Precautions Limitations and Hazards for additional information 6 Replace the front covers 7 Wipe the surface of the instrument with disinfectant Refer to Chapter 8 Precautions Limitations and Hazards for additional information Repackaging for Shipment When the CELL DYN 3000 is to be shipped and the original packaging is available repackage the instrument as it was originally shipped W...

Page 428: ... 10 32 Sample Loader Aspiration Needle or Vent Needle 10 33 Procedure 10 34 Aperture 10 36 Syringes 10 37 Troubleshooting Tips and Techniques 10 38 Introduction 10 38 Troubleshooting the Background Count 10 38 Troubleshooting Reagent Problems 10 39 Troubleshooting the Incomplete Aspiration Sampling Error Message 10 39 Troubleshooting RBC Clog and Flow Error Messages 10 40 Troubleshooting the WBC F...

Page 429: ...Table of Contents 2 CELL DYN 3000 System Operator s Manual 9140240E May 1995 Table of Contents Chapter 10 NOTES Search Go Back Book TOC ...

Page 430: ...scription of the fault can be obtained by pressing the FAULT REPORT key on the DIAGNOSTICS MENU Screen The first section of this chapter discusses the DIAGNOSTICS MENU keys The remainder of the chapter is devoted to the Troubleshooting Guide The Troubleshooting Guide is designed to assist the operator in identifying and resolving instrument problems Instructions are also given for obtaining techni...

Page 431: ...10 2 CELL DYN 3000 System Operator s Manual 9140240E May 1995 Troubleshooting Chapter 10 NOTES Search Go Back Book TOC ...

Page 432: ...cute programs 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 service representatives and is not useful to the operator If certain keys are pressed inadvertently the system may have to be initialized There are five primary screens in the DIAGNOSTICS MENU For ease of ...

Page 433: ... labels are displayed when the DIAGNOSTICS key is pressed FAULT REPORT EXECUTION TIMES CNT RATE SUMMARY CLEAR FAULTS RAW DATA SUMMARY MORE PRINT MAIN Figure 10 1 First Diagnostics Menu Screen FAULT REPORT EXECUTION TIMES CNT RATE SUMMARY CLEAR FAULTS RAW DATA SUMMARY MORE PRINT MAIN DIAGNOSTICS MENU Ready Jan 18 1993 Operator ID Sequence 10 20 734 0630 Search Go Back Book TOC ...

Page 434: ...2 or FATAL FAULT REPORT see Figure 10 3 and any additional information available If there is no fault the screen displays the words NO FAULT PENDING See Figure 10 4 Figure 10 2 Operator Correctable Fault Report Screen FAULT REPORT FAULT REPORT EXECUTION TIMES CNT RATE SUMMARY CLEAR FAULTS RAW DATA SUMMARY MORE PRINT MAIN DIAGNOSTICS MENU Diluent empty Jan 20 1993 Operator ID Sequence 12 28 734 271...

Page 435: ...ressing the CLEAR FAULTS key after taking corrective action After corrective action for a fatal fault the system must be initialized FAULT REPORT EXECUTION TIMES CNT RATE SUMMARY CLEAR FAULTS RAW DATA SUMMARY MORE PRINT MAIN DIAGNOSTICS MENU Fault See DIAG Jan 20 1993 Operator ID Sequence 12 20 734 2713 Fatal fault report RBC diluent syringe overpressure RBC diluent syringe overpressure Search Go ...

Page 436: ...abel alternates between these two when the soft key is pressed RBC CNT RATE or RBC RATE GRAPH The label alternates between these two when the soft key is pressed PLT CNT RATE or PLT RATE GRAPH The label alternates between these two when the soft key is pressed PRINT RETURN FAULT REPORT EXECUTION TIMES CNT RATE SUMMARY CLEAR FAULTS RAW DATA SUMMARY MORE PRINT MAIN DIAGNOSTICS MENU Ready Jan 20 1993...

Page 437: ...r the selected parameter from the last cycle run When each key is pressed the count rate data is displayed see Figure 10 6 and the key label changes to RATE GRAPH for that parameter WBC CNT RATE RBC CNT RATE PLT CNT RATE PRINT RETURN DIAGNOSTICS MENU Ready Jan 20 1993 Operator ID Sequence 12 29 734 2715 Max diff WBC 311 RBC 295 PLT 767 Search Go Back Book TOC ...

Page 438: ...yed as a graph See Figure 10 7 The kinetic data and graph are useful when troubleshooting problems related to these parameters WBC RATEGRAPH RBC CNT RATE PLT CNT RATE PRINT RETURN DIAGNOSTICS MENU Ready Jan 20 1993 Operator ID Sequence 12 30 734 2716 Max diff WBC 18 RBC 7 PLT 45 WBC TOTAL COUNT 5934 TIME 0 50 1 05 1 55 2 07 2 57 3 08 3 62 4 12 COUNT 361 808 1183 1576 1989 2359 2799 3225 RATE 714 8...

Page 439: ... An example of the RAW DATA SUMMARY Screen is shown in Figure 10 8 The most useful information for the operator the metering times and the HGB reference and sample readings is highlighted in Figure 10 8 The information on metering times may be used to assist in troubleshooting chronic clog or flow error messages The HGB reference and sample readings may be used to assist in troubleshooting erratic...

Page 440: ...ons in this way on each screen Therefore it will not be discussed again in this section The MAIN key is used to return to the MAIN MENU Screen The MAIN key appears on each primary DIAGNOSTICS MENU Screen and works the same way on each screen Consequently it will not be discussed again in this section FAULT REPORT EXECUTION TIMES CNT RATE SUMMARY CLEAR FAULTS RAW DATA SUMMARY MORE PRINT MAIN DIAGNO...

Page 441: ...D OPERATION PUMP OPERATION INITIALIZATION MORE MAIN Figure 10 9 Second Diagnostics Menu Screen This key is for service use only The system must be initialized after this key is pressed This key is for service use only The system must be initialized after this key is pressed MOTOR OPERATION SOLENOID OPERATION PUMP OPERATION INITIAL IZATION MORE MAIN DIAGNOSTICS MENU Ready Jan 18 1993 Operator ID Se...

Page 442: ...se two selections PRESSURE ON or PRESSURE OFF The key label alternates between these two selections INHIBIT PUMPS or ENABLE PUMPS This key is displayed after either key listed above it is pressed VACUUM TEST PRESSURE TEST DIAGNOSTICS Figure 10 10 Pump Operation Screen PUMP OPERATION VACUUM ON PRESSURE ON VACUUM TEST PRESSURE TEST DIAG NOSTICS DIAGNOSTICS MENU Not Ready See DIAG Jan 28 1993 Operato...

Page 443: ...e pump does not turn ON when the key is pressed the pump may be the cause of the vacuum problem Figure 10 11 Pump Operation Screen Vacuum 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 OFF NOTE The pump is automatically turned OFF and control o...

Page 444: ... to the instrument when the screen is exited This key is useful when performing maintenance or troubleshooting procedures that require a vacuum or pressure line to be removed Figure 10 12 Inhibit Pumps Screen When the VACUUM TEST key is pressed the system releases the vacuum to atmosphere and then determines the amount of time required for it to return to the correct level The key labels disappear...

Page 445: ...mplete the time stops incrementing and the key labels are displayed The DIAGNOSTICS key is used to return to the DIAGNOSTICS MENU Screen When the INITIALIZATION key is pressed the Analyzer is initialized This is necessary when a fatal fault has occurred When the Analyzer is initialized a prime cycle must be run NOTE A prime cycle is automatically run whenever the RUN key is pressed after the syste...

Page 446: ...ee Figure 10 14 and the following soft key labels are displayed DIGITAL READINGS VOLTAGE READINGS MORE PRINT MAIN Figure 10 14 Third Diagnostics Menu Screen This key is for service use only MORE DIGITAL READINGS VOLTAGE READINGS MORE PRINT MAIN DIAGNOSTICS MENU Ready Jan 18 1993 Operator ID Sequence 10 21 734 0630 DIGITAL READINGS Search Go Back Book TOC ...

Page 447: ...2 40 734 3143 Arrow keys to move around SELECT key to select FINISH SELECT key to go DCM slf tst f DAC 0 00 99mv refrence 0 08 15v 2 pwr sp 7 49 5v pwr sp 5 14 slf test ramp 9 99 9 901v refrnce 9 86 15v 2 pwr sp 7 55 SPM WBC threshold 0 86 SPM tst f DAC 0 00 WBC ch 1 peak 0 00 RBC peak 0 00 RBC threshold 0 57 5v supply 5 12 WBC ch 2 peak 0 00 RBC intgral 0 00 PLT L thrshld 0 53 10v refrence 9 97 W...

Page 448: ...e Figure 10 16 and the following soft key labels are displayed GAIN ADJUSTMNT WBC DATA RBC DATA PLT DATA MORE PRINT MAIN These keys are for service use only Figure 10 16 Fourth Diagnostics Menu Screen MORE GAIN ADJUSTMNT WBC DATA RBC DATA PLT DATA MORE PRINT MAIN DIAGNOSTICS MENU Ready Jan 18 1993 Operator ID Sequence 10 20 734 0630 Search Go Back Book TOC ...

Page 449: ...ft key labels are displayed AUTO SAMP VERSION BAR CODE ALIGNMENT BAR CODE VERIFY SERIAL TEST MORE PRINT MAIN These keys are displayed on the CELL DYN 3000SL only Figure 10 17 Fifth Diagnostics Menu Screen CELL DYN 3000SL MORE AUTO SAMP VERSION BAR CODE ALIGNMENT BAR CODE VERIFY SERIAL TEST MORE PRINT MAIN DIAGNOSTICS MENU Ready Jan 18 1993 Operator ID Sequence 12 49 734 3122 Search Go Back Book TO...

Page 450: ...owed by the version information NOTE This key is displayed on the CELL DYN 3000SL only Figure 10 18 Auto Sampler Version Screen This key is for service use only and is displayed on the CELL DYN 3000SL only This key is for service use only and is displayed on the CELL DYN 3000SL only AUTO SAMP VERSION AUTO SAMP VERSION BAR CODE ALIGNMENT BAR CODE VERIFY SERIAL TEST MORE PRINT MAIN DIAGNOSTICS MENU ...

Page 451: ...nector may remain connected to the external computer port for convenience as it does not interfere with routine operation If an LIS is usually connected the loop back connector should be stored near the instrument when the connector is not in use When the key is pressed the following soft key labels see Figure 10 19 are displayed STOP TRANSMISS TRANSMIT MESSAGE DIAGNOSTICS Figure 10 19 Serial Test...

Page 452: ...Data Station The screen see Figure 10 20 displays the message MESSAGE SENT CD 3000 serial interface test If the test is successful the screen displays the message MESSAGE RECEIVED CD 3000 serial interface test This message indicates that the Data Station is communicating properly If the test is not successful no message appears Figure 10 20 Serial Test Transmit Message Screen STOP TRANSMISS TRANSM...

Page 453: ... Manual 9140240E May 1995 Troubleshooting Chapter 10 The DIAGNOSTICS key is used to return to the previous DIAGNOSTICS MENU Screen The MORE key is used to return to the first DIAGNOSTICS MENU Screen DIAGNOSTICS MORE Search Go Back Book TOC ...

Page 454: ...rking correctly Once this is done the troubleshooting process moves quickly to the next step Step 2 Problem Isolation further classifies the problem Instrument problems are generally divided into three categories Hardware component related Software computer program related Measurement related to sample analysis Typically hardware and software problems are corrected by an authorized Abbott service ...

Page 455: ...be prepared to provide the following information for the Customer Support Specialist 1 Instrument Model Name 2 Serial number of the Analyzer and software version in use 3 Description of the problem whenever possible print the fault status report obtainable from the DIAGNOSTICS MENU Screen 4 The lot numbers and expiration dates of the CELL DYN reagents and controls currently in use 5 Examples of su...

Page 456: ...RTANT The laser must be allowed to warm up for 15 minutes after the power is turned ON if the power has been OFF more than five minutes Do not process samples during this warm up period 1 Verify that all components are properly installed for example syringes shear valve etc 2 Verify that all reagents are properly installed 3 Verify that all necessary cables and power cords are properly connected 4...

Page 457: ...e NOTE If the instrument will be inactive for more than two weeks perform the clean for shipping cycle instead of the daily shutdown cycle Refer to the instructions given in Chapter 9 Maintenance for performing this cycle 4 Turn the power switches OFF in the following order a Data Station b Analyzer c Sample Loader if present d Printer NOTE In an emergency situation turn OFF the power switches in ...

Page 458: ...tatus box The reagent priming step is necessary after any initialization This is accomplished by pressing RUN or PRIME whichever is displayed All reagents are primed automatically a background cycle is performed and the results are displayed on the RUN Screen When the reagents are primed the message READY is displayed in the status box On the CELL DYN 3000SL the Sample Loader may be initialized by...

Page 459: ...ARNING Potential Biohazard Follow established biosafety practices when performing maintenance service or troubleshooting procedures Wear gloves lab coat and suitable eye protection The probe is potentially contaminated with infectious material Refer to Chapter 8 Precautions Limitations and Hazards for additional information CAUTION Use powder free gloves when performing this procedure to avoid con...

Page 460: ...filament line from the probe 4 Reconnect the tubing to the top of the probe 5 Perform an Auto Clean procedure If necessary refer to the directions given in Chapter 9 Maintenance 6 When the Auto Clean procedure is complete run a blood sample and check for complete aspiration There should be a minimum of one inch of blood on either side of the shear valve tubing 7 If aspiration is not complete call ...

Page 461: ... in the accessory kit Checking or Changing the Analyzer Fuse CAUTION Always turn the Analyzer power switch OFF and disconnect the power cord from the receptacle before checking or changing the fuse 1 Turn the Analyzer power switch OFF and disconnect the power cord from the receptacle 2 Insert a screwdriver in the fuse holder slot on the rear panel of the Analyzer 3 Push in and turn the fuse holder...

Page 462: ...ice or troubleshooting procedures Wear gloves lab coat and suitable eye protection Refer to Chapter 8 Precautions Limitations and Hazards for additional information CAUTION The needles are sharp and are potentially contaminated with infectious material Handle with extreme caution CAUTION Use powder free gloves when performing this procedure to avoid contaminating the instrument Materials Required ...

Page 463: ...F 2 Remove all racks from the tray 3 Place some gauze under the aspiration needle and or vent needle to catch any liquid 4 Disconnect the sample aspiration tubing from the Analyzer NOTE The tubing is connected on the left side of the open sample aspiration probe Aspiration Tubing Locking Mounting Bracket Aspiration Needle Aspiration Needle Wash Block Waste Tubing Port Vent Tubing Locking Screw Mou...

Page 464: ... silicon tubing sleeve onto the aspirate tubing before disconnecting it 11 Remove the aspiration needle by pulling it up through the wash block and the mounting bracket CAUTION Use care when removing the needle to avoid puncture 12 Insert the new aspiration or vent needle through the mounting bracket and down through the wash block until the wide collar at the top of the needle is flush with the t...

Page 465: ...ot use excessive force Aperture It may be necessary to replace the RBC PLT aperture if no other solution to a related problem is found If you are replacing the aperture verify that the correct aperture has been received RBC PLT apertures are identified by R P etched on the plate Use the following procedure to replace the aperture 1 Perform the Auto Clean procedure as directed in Chapter 9 Maintena...

Page 466: ...btain the appropriate replacement syringe Then use the following procedure 1 Remove the syringe in question as directed in the syringe cleaning procedure given in Chapter 9 Maintenance and set it aside 2 Install the new syringe as directed in the syringe cleaning procedure and follow the remaining steps in that procedure 3 Repeat samples that were run when the problem was detected to determine if ...

Page 467: ...ccurred 3 Check the reagent log maintenance log and if applicable service reports to see if the problem occurred immediately after a specific action For example did the problem occur immediately after the reagent was changed 4 Check the background count in the open and closed modes to see if the problem is common to both modes 5 Run an electrical background count using the Electrical Background sp...

Page 468: ...new container Place the line in the new container and secure the cap 3 Press the FILL REAG RESERVOIR key to refill the reservoirs 4 Run five background counts before assessing the results Troubleshooting the Incomplete Aspiration Sampling Error Message 1 Check to see if the problem occurs in both the Open and Closed modes of operation If the problem is confined to one mode only the other may be el...

Page 469: ...only available immediately after the cycle is completed Therefore the screen should be printed immediately after the clog or flow error occurs From the first DIAGNOSTICS MENU Screen press RAW DATA SUMMARY followed by PRINT to obtain a printout 4 Information pertaining to the vacuum level in the Analyzer can be found on the VOLTAGE READINGS Screen From the third DIAGNOSTICS MENU Screen press VOLTAG...

Page 470: ... nine Closed mode runs into the same file For the CELL DYN 3000SL aliquot a sample into three tubes and run each tube three times Use the REJECT SPECIMEN key to reject the Open mode runs and obtain a printout This information can be used to determine if the problem is mode or measurement related 3 Compare the CVs of the precision data from a normal fresh whole blood sample to the CVs of precision ...

Page 471: ...owed by PRINT to obtain a printout If there is a flagging problem or a problem with an abnormal sample obtain a printout of a 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 6 RBC HGB MCV and PLT Configure the RUN Screen to d...

Page 472: ...ke action relative to the last operator entry 2 Fault Conditions indicate fault or error detection The status conditions are listed in Table 10 1 This table defines each message and indicates its display location General fault conditions are listed in Table 10 2 and sample related fault conditions are listed in Table 10 3 Nonfunctional fault conditions are listed in Table 10 4 Each table lists the...

Page 473: ...10 44 CELL DYN 3000 System Operator s Manual 9140240E May 1995 Troubleshooting Chapter 10 NOTES Search Go Back Book TOC ...

Page 474: ...imits were exchanged to make upper lower 10 48 Westgard Warning See Levey Jennings 10 49 No entry found 10 49 Duplicated Specimen ID 10 49 Duplicated 4 digit Bar Code ID 10 49 Bar Code flag not allowed to change unless Work List is purged 10 50 Auto Sampler Off 10 50 Auto Sampler Initializing 10 50 Auto Sampler Ready 10 50 Auto Sampler Pause 10 50 Auto Sampler Busy 10 51 Samples Completed 10 51 Ch...

Page 475: ... is displayed in the status box __________________________________________________________ Entering standby SB Explanation Action The instrument has been idle for four hours and therefore is automatically performing a cleaning cycle before entering the STANDBY state Pressing the DAILY SHUTDOWN key also initiates this message When the cycle is complete press PRIME or RUN to initiate the priming cyc...

Page 476: ...are being exercised to be sure that tubing is not pinched shut Resume processing when the READY message is displayed in the status box __________________________________________________________ Extended Count SB Explanation Action A low value has been detected for the WBC and or PLT count The Analyzer is automatically extending the cycle to count more cells Press PRIME to resume processing _______...

Page 477: ...utomatically changed Check to be sure the entered values are correct If appropriate recalculate the mean and limits and enter correct values __________________________________________________________ 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 no...

Page 478: ... LOG SEARCH Screen is not present in the data log Check that the entry was correct If appropriate enter the correct number __________________________________________________________ Duplicated Specimen ID BL Explanation Action The work list already contains the specimen ID number that has been entered It is not possible to enter the same specimen ID number twice in the work list If appropriate del...

Page 479: ...for the initialization cycle to be completed __________________________________________________________ Auto Sampler Initializing BL Explanation Action The Sample Loader hardware initialization cycle is in progress Wait for the cycle to be completed __________________________________________________________ Auto Sampler Ready BL Explanation Action The Sample Loader initialization cycle is complete...

Page 480: ...__________________________ 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 Auto Sampler is not busy BL Explanation Action The CHANGE SAMPLER key was pressed while the...

Page 481: ...ense that the safety cover was in place Replace the safety cover and then press the START key __________________________________________________________ Auto Sampler Emergency stop BL Explanation Action The Sample Loader E STOP key was pressed during operation and the Sample Loader is stopped Press the INIT key if the light on the key is blinking to initialize the Sample Loader If the INIT key lig...

Page 482: ... 58 Shear Valve position fault 10 59 RBC diluent syringe overpressure 10 59 Vacuum accumulator 1 or 2 wet 10 59 Flow sequence time out x x 10 60 Command sent at incorrect time 10 60 Data acquisition overlap 10 61 List mode data phase error 10 61 Message acknowledgment time out 10 62 Message reception time out 10 62 Run time error 10 62 Bad checksum in non volatile RAM 10 63 Bad monitor command 10 ...

Page 483: ...anel is illuminated in red Probable Cause Corrective Action 1 A situation that prevents 1 From the first DIAGNOSTICS the READY state has been MENU Screen press detected See the FAULT REPORT followed DIAGNOSTICS MENU by PRINT to obtain a Screen or the SPECIAL printout describing the PROTOCOLS MENU Screen problem Refer to the whichever is indicated for for appropriate table for more information corr...

Page 484: ...Station to the Data Station If necessary secure the connections Initialize the Analyzer by pressing the INITIALIZATION key on the second DIAGNOSTICS MENU Screen __________________________________________________________ Initialization Failed Bottom of screen MAIN MENU is not displayed Probable Cause Corrective Action 1 The Data Station was 1 Initialize the Analyzer by unable to initialize The foll...

Page 485: ... PRINTED REPORT Screen for the appropriate printer 2 The printer is turned OFF 2 Turn the printer power switch ON 3 The printer is not on line 3 Check that the printer on line indicator is illuminated If necessary refer to the printer manual for assistance 4 The printer is disconnected 4 Check the printer cable or the connection is loose connection on the back of the Data Station and on the back o...

Page 486: ...d to ensure it is not crimped and or remove any obstruction 3 Reagent line is not on 3 Ensure that the line is the bottom of the properly inserted in the container container and the sinker is on the bottom of the container 4 An incorrect reagent or a 4 Check the label on the nonconductive liquid is reagent container to be sure connected to the inlet tube the correct reagent is installed Trace the ...

Page 487: ...sistance 4 Circuitry malfunction 4 Call for technical assistance __________________________________________________________ Blood in Line BL Probable Cause Corrective Action 1 At the beginning of the 1 Check the sample line to see count cycle the instrument if it contains blood If it detects blood in the sample does clean or replace the line that runs from the top Sample Loader needle of the Sampl...

Page 488: ...lean the RBC diluent detected during the syringe up stroke of the RBC diluent syringe 2 The shear valve did not 2 Clean the shear valve rotate completely or in the time allotted 3 The center section of the 3 Verify that the center shear valve is installed section of the shear valve backwards is installed correctly 4 If the problem persists call for technical assistance ____________________________...

Page 489: ...n the allotted time Support Center to report the problem at 1 800 CELL DYN Initialize the Analyzer by pressing the INITIALIZATION key on the second DIAGNOSTICS MENU Screen Resume processing if the fault does not recur __________________________________________________________ Command sent at incorrect time BL Probable Cause Corrective Action 1 The Analyzer received a 1 Initialize the Analyzer by c...

Page 490: ...port Center Initialize the Analyzer by pressing the INITIALIZATION key on the second DIAGNOSTICS MENU Screen Resume processing if the fault does not recur NOTE The error may occur when several tasks are requested in rapid sequence For example print data log transmit result sample processing print ticket print report etc __________________________________________________________ List mode data phas...

Page 491: ... time out BL Probable Cause Corrective Action 1 Communication between 1 Initialize the Analyzer by the Analyzer and the Data pressing the Station did not occur when INITIALIZATION key on expected the second DIAGNOSTICS MENU Screen If the fault recurs call for technical assistance __________________________________________________________ Run time error BL Probable Cause Corrective Action 1 An ille...

Page 492: ...ansmit the correct message to the Data Station __________________________________________________________ Bad monitor command BL NOTE This message does not pertain to the Data Station screen CRT Probable Cause Corrective Action 1 During the initialization 1 Initialize the Analyzer process the Data Station by pressing the and Analyzer did not INITIALIZATION key communicate properly on the second DI...

Page 493: ...ize the Sample Loader and bring the Data Station to the READY state OR From the DIAGNOSTICS menu press the FAULT REPORT soft key Then press the CLEAR FAULTS soft key to reinitialize the Sample Loader and bring the Data Station to the READY state It is not necessary to press the Sample Loader RESET key 2 The rack and or position 2 Check and or replace the ID label is unreadable rack ID position ID ...

Page 494: ...fault does not recur 2 Circuitry malfunction 2 Call for technical assistance __________________________________________________________ Auto Sampler command negatively acknowledged BL Probable Cause Corrective Action 1 The Sample Loader did 1 Ensure that the Sample not respond to an Analyzer Loader power cord is command connected to the Sample Loader and that the cord is connected to the power out...

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Page 496: ...ooting Summary of Table 10 3 Sample Related Fault Conditions Condition Page Sampling Error Incomplete Aspiration 10 68 Mixing Error 10 69 Auto Sampler consecutive data faults 10 70 WBC Metering Fault Flow Error 10 71 RBC Metering fault Clog or Flow error 10 72 Search Go Back Book TOC ...

Page 497: ...e right of the MCHC result SAMPLING ERR is printed on the graphics and pre printed ticket report SAMPLING ERROR is printed on the blank ticket Probable Cause Corrective Action 1 The blood sensors did 1 Check the sample tube to not detect a sufficient be sure it contains a amount of sample sufficient quantity of during aspiration blood 2 Clean the open sample aspiration probe as directed in the Tro...

Page 498: ...ed on all reports Probable Cause Corrective Action 1 The blood sensors did 1 Check the sample tube to not detect a sufficient be sure it contains a amount of sample sufficient quantity of during aspiration blood 2 Clean the open sample aspiration probe as directed in the Trouble shooting Procedures section of this chapter or the closed mode needle CS or SL as directed in Chapter 9 Maintenance to r...

Page 499: ...were detected and the Check the appropriate Sample Loader halted tubing for a plug or pinch Press CLEARORIFICE to clear the aperture Clean the Sample Loader needle If necessary refer to the instructions given in Chapter 9 Maintenance 2 Press the CLEAR FAULT key displayed on the RUN Screen The Sample Loader automatically resumes processing 3 If the problem persists follow the instructions given in ...

Page 500: ...t Results for WBC and Differential are suppressed Probable Cause Corrective Action 1 An increasing WBC count 1 Repeat the sample rate was detected in the WBC flow cell during the WBC measurement 2 Change the WBC transfer peristaltic pump tubing as directed in Chapter 9 Maintenance 3 Clean the WBC metering syringe as directed in Chapter 9 Maintenance 4 Refer to the Trouble shooting Tips and Techniq...

Page 501: ...t Results for RBC PLT and related parameters are suppressed Probable Cause Corrective Action 1 The timing for the RBC PLT 1 Repeat the sample If the metering was outside problem was caused by acceptable limits debris in the aperture the automatic cleaning cycle may have corrected it 2 Clean the RBC PLT aperture as directed in Chapter 9 Maintenance NOTE The Analyzer automatically cleans the RBC PLT...

Page 502: ...en is not displayed after initialization 10 75 The word FAULT on the Analyzer status indicator panel is illuminated in red 10 76 Instrument will not stop cycling 10 76 Background count is outside acceptable limits 10 77 The Data Station keyboards are not operational 10 78 The Sample Loader does not power ON 10 79 The Sample Loader beeps and the START key is not illuminated 10 79 The System does no...

Page 503: ...s located or incorrect above the power cord con nector on the rear panel Check the fuse as directed in the Troubleshooting Procedures section of this chapter CAUTION Always turn the Analyzer power switch OFF and disconnect the power cord from the receptacle before checking or replacing any fuse 4 Defective power switch or 4 Call for technical assistance other system malfunction ___________________...

Page 504: ...r switch OFF and ON 2 The external keyboard 2 Disconnect the external is defective keyboard from the Data Station and then initialize the Data Station by turning the power switch OFF and ON If the MAIN MENU Screen is displayed after initialization is complete call the Customer Support Center and report the problem Resume operation using the Data Station membrane keyboard 3 A file is missing or is ...

Page 505: ...perform the indicated 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 __________________________________________________...

Page 506: ...lete repeat the background count Remove and clean the RBC PLT aperture plate Repeat the background count 3 The reagents are cold 3 Allow the reagents to warm to room temperature and then repeat the background count 4 The reagents may be 4 Replace the appropriate contaminated reagent according to the directions given in the Troubleshooting the Background Count procedure and the Trouble shooting Rea...

Page 507: ...keys current Status Box message 2 There is an incomplete 2 Complete the operator operator entry entry or press the Esc key on the keyboard 3 A data transmission to 3 No action required Refer the printer or laboratory to the screen for the computer is in progress Status Box message 4 Keyboard entry is not 4 No action required Refer possible on the displayed to the screen for the screen current Stat...

Page 508: ... and the START key is not illuminated Probable Cause Corrective Action 1 The cable that connects 1 Check that each end of the the Sample Loader to the cable is securely connected Analyzer is loose or If necessary remove the disconnected cable and reconnect it Press the INIT key on the Sample Loader operation keyboard to initialize the Sample Loader 2 Circuitry malfunction 2 Call for technical assi...

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Page 510: ...le of Contents 1 9140240E May 1995 Chapter 11 Printer Chapter Table of Contents Introduction 11 1 Printing Graphics Reports 11 1 Printing Tickets 11 1 Loading Individual Tickets 11 2 Maintenance 11 5 Troubleshooting 11 6 Search Go Back Book TOC ...

Page 511: ...Table of Contents 2 CELL DYN 3000 System Operator s Manual 9140240E May 1995 Table of Contents Chapter 11 NOTES Search Go Back Book TOC ...

Page 512: ...pter 5 Operating Instructions For a detailed description of the printer components and instructions for changing the ribbon and loading paper refer to the manuals that accompany the printer In particular note the important safety instructions Printing Graphics Reports To print graphics the printer cable must be connected to the graphics printer port on the back of the Data Station See Figure 2 1 f...

Page 513: ...or loading individual tickets If fanfold continuous feed tickets are used they should be loaded as directed in the printer manual for tractor feed paper 1 Be sure that the printer is turned ON and the printer cable is connected to the ticket printer port on the back of the Data Station If the connection is incorrect turn the Data Station power OFF change the position of the cable and turn the powe...

Page 514: ...ocked position 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 Lower Red Line on Paper Shield Headgap Lever Paper Guide Paper Lever in Single Sheet Position Paper Lever in Tractor Feed Position Paper Separator Printer Power On Off Switch Guide Wire in Locked Position Bail Lever Access Cove...

Page 515: ...ove 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 ticket below the paper bail 9 Position the ticket so that the lower red line on the paper shield located between the print head and the paper is positioned where the first line of printing s...

Page 516: ...clean dry cloth to dust the area around the carriage shaft and platen Be sure to remove any loose particles of paper Do not use solvents or strong detergents on the cabinet WARNING Be sure to turn the printer OFF and disconnect the power cord before cleaning Figure 11 2 Printer Carriage Shaft and Platen Platen Carriage Shaft Search Go Back Book TOC ...

Page 517: ...E is displayed on the bulletin line check to see that the printer cable is securely connected to the Data Station the printer power switch is turned ON and that the SEL indicator is illuminated Press the PRINT key on the Data Station screen If the message is still displayed turn the printer power OFF wait about five seconds turn the power ON again and press the PRINT key on the Data Station screen...

Page 518: ...2 CELL DYN Bar Code Labels 12 2 CELL DYN Q Labels 12 2 Bar Code Label Placement 12 3 Sample Loader Components 12 4 Sample Loader Operation Keyboard Keys 12 5 Operating Principles 12 7 Functional Description 12 7 Function Sequence 12 12 Routine Operating Procedures 12 15 Maintenance 12 15 Installation 12 15 Troubleshooting 12 15 Search Go Back Book TOC ...

Page 519: ...Table of Contents 2 CELL DYN 3000 System Operator s Manual 9140240E May 1995 Table of Contents Chapter 12 NOTES Search Go Back Book TOC ...

Page 520: ... that maintain the tubes in an upright position The Sample Loader accommodates up to 100 samples with or without bar code labels Figure 12 1 Analyzer with Sample Loader Once initialized when the START key on the Sample Loader is pressed racks move to advance each tube through three processing stations located on the tower unit Station 1 Venting tube sensed tube positioned by the plunger and tube s...

Page 521: ...Analyzer to provide bidirectional communication Refer to Chapter 4 System Specifications for complete specifications for the Sample Loader Labels CELL DYN Bar Code Labels CELL DYN 4 digit bar code labels are available for the Sample Loader L N 99650 01 for one roll or L N 99651 01 for a box of ten These labels may be used for positive specimen identification when laboratory generated bar code labe...

Page 522: ...from mixing properly Figure 12 3 Tube Labeling Requirements The bar code label should be placed on the tube just below the stopper with the bars perpendicular to the length of the tube See Figure 12 3 for proper placement NOTE Refer to Appendix A Bar Codes for complete information on bar codes and specifications Properly Labeled Tubes Improperly Labeled Tubes Top Surface Should Be Dry 16 5 mm Widt...

Page 523: ...oader The main module contains Power On Off switch Power and communication connectors Operation keyboard Safety cover Tray to hold the tube racks The tower unit contains Vent needle and vent needle wash block One mixing head Aspiration needle and aspiration needle wash block Tube sensor Vial positioning mechanism referred to as the plunger Bar code reader NOTE A detailed functional description of ...

Page 524: ...ocessing whenever the CELL DYN 3000SL is in the closed mode READY state PAUSE Pauses processing after the current cycle is completed This key is used any time the processing needs to be interrupted REPEAT Moves the sample back to the mixing station and remixes it prior to re aspiration RESET Resets the Sample Loader and activates the INIT key usually in conjunction with an activated alarm situatio...

Page 525: ...eys are located under a removable cover that is held in place by a set of thumbscrews These keys are used to check specific Sample Loader functions during troubleshooting or service These keys should only be used at the direction of the Customer Support Center or an authorized Abbott representative Search Go Back Book TOC ...

Page 526: ... Loader operation keyboard is located on the right side of the main module See Figure 12 4 Three stations located on the Sample Loader tower unit are used to vent mix and aspirate each sample tube See Figure 12 6 A tube detection sensor checks for the presence of a tube at Station 1 If a tube is detected the vent needle punctures the stopper to vent the tube to atmospheric pressure At Station 2 th...

Page 527: ...he tube stopper to be pierced in the center and the rack to accommodate tubes with varying numbers of labels Ten tube racks must be in place for Sample Loader operation The end rack is marked with black labels on top and a black label on the left end of the rack See Figure 12 7 This rack is used to indicate the last rack of a specific run The Sample Loader automatically stops when the end rack rea...

Page 528: ...oader is operating causes an immediate emergency stop condition and the current sample must be rerun CAUTION If a Sample Loader fault occurs that necessitates initialization of the Sample Loader remove all samples that have been processed before restarting the Sample Loader If these samples are not removed misidentification of the remaining samples will occur When the Sample Loader detects the end...

Page 529: ... rack ID labels on tube racks are mandatory for proper Sample Loader operation They must be placed on racks between tube positions 1 and 2 even if bar code labels on samples are not used For more information refer to Chapter 2 Installation The bar coded rack ID label identifies each rack by number and is read by the bar code reader The system tracks the rack number and tube position for each sampl...

Page 530: ...der at Station 2 As each tube reaches Station 2 the tube rotates and the bar code reader turns on to read the bar code label on the tube If no bar code label is present or the label is unreadable the sample is identified by the rack number and tube position in the format R n T n on the Data Station RUN Screen and in the Data Log The use of bar code labels is recommended for positive sample identif...

Page 531: ...monitored by a sensor in each corner of the Sample Loader tray A fifth sensor detects the non reflective black label on the end rack 1 Each time the Sample Loader is switched ON it completes an initialization cycle 2 When the Sample Loader is initialized and ready the START key on the Sample Loader Keyboard flashes and the message AUTO SAMPLER READY appears in the Data Station bulletin line 3 When...

Page 532: ... and printed to the right of the MCHC result An M appears in the column preceding the date in the data log and the QC log 6 Rack movement resumes and the first sample is moved to Station 3 When the aspiration needle begins to move down the plunger moves forward to position the tube so the stopper is pierced near the center The needle moves down and the Sample Loader signals the Analyzer to aspirat...

Page 533: ... rack When all tubes in this rack are processed the Sample Loader automatically stops and audible beeps alert the operator that processing is completed The message SAMPLES COMPLETED is displayed in the bulletin line NOTE An end rack is required to stop sampling automatically unless the Sample Loader is manually stopped or a fault occurs Search Go Back Book TOC ...

Page 534: ...spiration needles and the weekly cleaning of the tray and the tube racks If the vent or aspiration needle requires replacement refer to Chapter 10 Troubleshooting Installation For detailed instructions on how to install the Sample Loader refer to Chapter 2 Installation Troubleshooting If a Sample Loader fault error or other problem is detected an alert message is displayed on the bulletin line of ...

Page 535: ...12 16 CELL DYN 3000 System Operator s Manual 9140240E May 1995 Sample Loader Chapter 12 NOTES Search Go Back Book TOC ...

Page 536: ...grated reader such as the one in the Sample Loader of CELL DYN 3000SL Analyzers The printer typically a high resolution laser printer for generating bar code labels The bar code labels themselves Bar Coding Function The bar code label contains the actual identifying data in the form of a series of black bars and contrasting white spaces which represent numbers and letters The arrangement of the co...

Page 537: ...canned from either right to left or left to right ensuring that code information is transmitted correctly Intercharacter gaps that act as spaces between each character in the bar code symbol Code 39 contains these gaps but other codes including Interleaved 2 of 5 do not use them The interpretation line an area at the bottom of the bar code label where human readable information can be placed This ...

Page 538: ...2 of 5 and Codabar formats The Sample Loader can read these formats interchangeably if the check digit is disabled by using the BAR CODE SETUP soft key from the OPERATION SETUP Screen Code size and collection tube length limit the number of characters per label as follows Code 39 maximum of 9 characters Do NOT use those that contain only a single letter or double letters A ZZ These labels are used...

Page 539: ...ese labels may be used for positive specimen identification when laboratory generated bar code labels are unavailable CELL DYN Q Labels Special bar code labels are available to identify QC specimens These Q labels numbers Q1 Q20 L N 99652 01 automatically select QC files 1 to 20 and therefore should be used to process only QC specimens Minimum Quiet Zone 0 25 inches Maximum Label Length 2 0 inches...

Page 540: ...m mixing properly The Bar Code Label should be placed on the tube just below the stopper with the bars perpendicular to the length of the tube See Figure A 2 for proper placement Figure A 2 Tube Labeling Requirements Properly Labeled Tubes Improperly Labeled Tubes Top Surface Should Be Dry 16 5 mm Width Limit For Multiple Labels Diameter Clear Tape Bar Code Label Exposed Bottom High Collar Tail Fl...

Page 541: ...9140240E May 1995 Bar Codes Appendix A Acknowledgment The authors wish to acknowledge Computype Inc of St Paul MN for providing their booklet Bar Coding and Productivity to assist in the writing of this appendix Search Go Back Book TOC Book TOC ...

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