Beckman Coulter COULTER ACT 5diff Operator Training Manual
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Beckman Coulter COULTER ACT 5diff Operator Training Manual

Autoloader hematology analyzer
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C
COULTER A
•T 5diff Autoloader
Hematology Analyzer
PN 177196BB (August 2012)
Manufactured for
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea, CA 92821 U.S.A.
Operator's
Training Guide

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  • Page 1 COULTER A •T 5diff Autoloader Hematology Analyzer Operator’s Training Guide PN 177196BB (August 2012) Manufactured for Beckman Coulter, Inc. 250 S. Kraemer Blvd. Brea, CA 92821 U.S.A.
  • Page 2 This equipment is used in a manner other than specified. Operate the instrument as instructed in the Product Manuals. r You introduce software that is not authorized by Beckman Coulter into your computer. Only operate your system’s computer with software authorized by Beckman Coulter.
  • Page 3 This document applies to the latest software listed and higher versions. When a subsequent software version changes the information in this document, a new issue will be released to the Beckman Coulter website. For labeling updates, go to www.beckmancoulter.com and download the most recent manual or system help for your instrument.
  • Page 4 REVISION STATUS PN 177196BB...

  • Page 5: Table Of Contents

    CONTENTS WARNINGS AND PRECAUTIONS, ii REVISION STATUS, iii CONTENTS, v INTRODUCTION, ix PURPOSE OF THIS DOCUMENT, ix TRAINING RESPONSIBILITIES, ix INSTRUMENT DOCUMENTATION, ix ABOUT THIS TRAINING GUIDE, x CONVENTIONS, xi SAFETY SYMBOLS, xii GETTING TO KNOW YOUR INSTRUMENT, 1-1 WORKSTATION HARDWARE, 1-1 WORKSTATION SOFTWARE AND THE ONLINE HELP SYSTEM, 1-4...
  • Page 6 CONTENTS SYSTEM SETUP OPTIONS, 3-9 CONFIGURATION SAVE AND RESTORE SETUP OPTIONS, 3-13 OPERATORS SETUP OPTIONS, 3-14 FLAGGING SETS SETUP OPTIONS, 3-16 QUALITY ASSURANCE, 4-1 SETTING UP OR MODIFYING CELL CONTROL FILES, 4-1 ANALYZING CELL CONTROLS, 4-3 INTERPRETING AND USING CELL CONTROL DATA, 4-9 CONTROL DATA MANAGEMENT, 4-13...
  • Page 7 CONTENTS DATA MANAGEMENT AND REVIEW, 7-1 DATA MANAGEMENT, 7-1 DATA ANALYSIS - AN OVERVIEW OF THE DILUTIONS AND MEASUREMENTS, 7-3 DATA ANALYSIS - MEASUREMENT PRINCIPLES, 7-9 DATA ANALYSIS REVIEW - WBC PARAMETERS, 7-15 DATA ANALYSIS REVIEW - RBC PARAMETERS, 7-21 DATA ANALYSIS REVIEW - PLATELET PARAMETERS, 7-27 SYSTEM DIAGNOSTICS AND...
  • Page 8 CONTENTS viii PN 177196BB...

  • Page 9: Training

    It is the Key Operator’ s responsibility to train all other Operators in the laboratory. Once trained by an authorized Beckman Coulter trainer, the Key Operator is authorized to use and make copies of any of the material in this Training Guide as needed for training other laboratory personnel.
  • Page 10 A •T 5diff AL hematology analyzer and your laboratory’ s host computer. The printed version is available by order. Contact your Beckman Coulter Representative if you want to order a printed copy of this manual. ABOUT THIS TRAINING GUIDE Scope This training guide is designed to support A •T 5diff AL hematology analyzer training.

  • Page 11: Conventions

    INTRODUCTION CONVENTIONS Organization The eight main topics contained in the Operator’ s Training Guide are part of a larger organization that includes four basic types of information. . Describes the format of the Training Guide and how it is meant to be used. Introduction .
  • Page 12 INTRODUCTION SAFETY SYMBOLS A Note: (in bold font) prefaces supplemental information. An ATTENTION (in bold font) prefaces information that is important to remember or helpful when doing a procedure. indicates a suggested task for the trainer or the trainee. Instrument or system is sometimes used to refer to the A •T 5diff Autoloader hematology analyzer (meaning both Analyzer and Workstation).

  • Page 13: Instrument,

    GETTING TO KNOW YOUR INSTRUMENT WORKSTATION HARDWARE A Objectives When you have completed this topic, you will be able to: B Locate and name the four major components of the computer system. B Locate and explain the function of specific keys on the keyboard. B Explain how to use the mouse to navigate through the software.
  • Page 14 GETTING TO KNOW YOUR INSTRUMENT WORKSTATION HARDWARE The computer houses the software program and communicates with the Analyzer. Point out the power ON/OFF switch and the indicator that lights when power is on. Identify the three drives: the hard drive indicator and symbol, the CD-ROM drive, and the diskette (floppy) drive.
  • Page 15 GETTING TO KNOW YOUR INSTRUMENT WORKSTATION HARDWARE Cursor control keys move the cursor. Arrow keys, è æ ç é, move the cursor bidirectionally, a line at a time. ä and å move the cursor up or down by a full page. â...
  • Page 16 GETTING TO KNOW YOUR INSTRUMENT WORKSTATION SOFTWARE AND THE ONLINE HELP SYSTEM WORKSTATION SOFTWARE AND THE ONLINE HELP SYSTEM A Objectives When you have completed this topic, you will be able to: B Log out from the Workstation. B Log into the Workstation correctly. B Locate the Generic toolbar and identify each icon.
  • Page 17 Service Service has full software access. Someone in the Service group must use a password. The Service group is reserved for Beckman Coulter Representatives and anyone who has completed the Beckman Coulter authorized service training on this instrument. A unique login name for each user is recommended so that instrument events can be traced back to the Operator.
  • Page 18 GETTING TO KNOW YOUR INSTRUMENT WORKSTATION SOFTWARE AND THE ONLINE HELP SYSTEM Log into the system and click . The Main Menu screen is displayed and the instrument goes through a hardware reset. Note the message at the bottom of the screen. Describe the Workstation screen elements.
  • Page 19 GETTING TO KNOW YOUR INSTRUMENT WORKSTATION SOFTWARE AND THE ONLINE HELP SYSTEM The Contextual toolbar is located across the bottom of every screen. This toolbar allows you to manage the screen information, display the help information, and exit the screen. Have the trainee pass the mouse pointer over each icon on the Contextual toolbar and read its name.

  • Page 20: Startup Procedure,

    GETTING TO KNOW YOUR INSTRUMENT WORKSTATION SOFTWARE AND THE ONLINE HELP SYSTEM Icon Function Initiates the Startup cycle. The Startup procedure is covered under Heading 2.1, STARTUP PROCEDURE, in this Training Guide. Opens the Run-in-Progress screen which allows you to view the results for the last sample analyzed.

  • Page 21: Printer

    The function of the Printer is to print either a copy of the screen displayed on the monitor or of data stored in the computer’ s database. Use the Printer supplied or approved by Beckman Coulter as their drivers have been checked for compatibility with the Workstation software.

  • Page 22: Bar-Code Scanner

    , in the Online Help System or BARCODE SPECIFICATIONS FOR OPTIONAL BARCODE WAND the Instructions for Use manual. Your Beckman Coulter Representative will ensure your Barcode Scanner is set up correctly to read your laboratory’ s bar-code labels. 1-10 PN 177196BB...

  • Page 23: Analyzer

    GETTING TO KNOW YOUR INSTRUMENT ANALYZER The instructions for using the Barcode Scanner correctly are under Heading 5.6, WORKING WITH BAR-CODE LABELS , in the Online Help System or the Instructions for Use manual. If your laboratory has a Barcode Scanner, using it correctly will be emphasized under Heading 6.2, SAMPLE IDENTIFICATION, in this Training Guide.
  • Page 24 GETTING TO KNOW YOUR INSTRUMENT ANALYZER Any screen on which the Generic toolbar icons are active can be displayed. To demonstrate the Manual and Autoloader modes, the trainer will need a few specimen tubes with pierceable caps. Either specimen tubes with blood samples or specimen tubes that are clean and empty can be used.
  • Page 25 , for the list of whole-blood collection devices and control vials compatible with the Cap-Pierce module. Beckman Coulter does not guarantee the performance of any tube in the Cap-Pierce module other than those listed. The list is not a recommendation for using one tube in preference to another nor does it guarantee the acceptability of the specimen tube to produce quality results.
  • Page 26 GETTING TO KNOW YOUR INSTRUMENT ANALYZER Pushing the door in past the closed position to the sampling position aligns the specimen for aspiration and initiates the cycle. Note: The door can only be pushed into the sampling position when has been selected and a sample ID entered. 10) When the Manual mode is initiated, the piercing needle and sampling probe are lowered to the assigned depth in the specimen tube.
  • Page 27 GETTING TO KNOW YOUR INSTRUMENT ANALYZER All 10 cassette styles are physically identical but it is possible to instruct the instrument to sample differently from cassette to cassette to accommodate different tubes. The bar-code label on the front of the cassette identifies the number of the cassette (1 through 10) and the style (A or B).
  • Page 28 GETTING TO KNOW YOUR INSTRUMENT ANALYZER After all the specimens in the cassette are analyzed, the Autoloader module moves the cassette to the right end of the track and then pushes the cassette onto the CASSETTE OUTPUT TRAY. The Operator removes the cassette and unloads the specimen tubes. For demonstration purposes, run a cassette with several specimen tubes.

  • Page 29: Reagents And Instrument Waste

    GETTING TO KNOW YOUR INSTRUMENT REAGENTS AND INSTRUMENT WASTE The default test panel is always used if the laboratory runs without a Worklist. If the laboratory uses a Worklist, a test panel can be selected for each specimen. Selecting the default test panel and the RUO parameters are setup options. These options are covered under Heading 3.1, MISCELLANEOUS (OPERATIONAL) SETUP OPTIONS, in this Training Guide.
  • Page 30 GETTING TO KNOW YOUR INSTRUMENT REAGENTS AND INSTRUMENT WASTE D Topic Notes and Tasks Reagents •T 5diff AL hematology analyzer uses four reagents to dilute and prepare the blood samples for analysis and one to clean the Analyzer. Four of these reagents are housed in the reagent compartment. Open the reagent compartment door, identify each of the reagents, and review the information for that reagent listed below.
  • Page 31 GETTING TO KNOW YOUR INSTRUMENT REAGENTS AND INSTRUMENT WASTE Open Container Reagent Label Color Function CBC DIFF Stability Green r Lyses red blood cells Same as shelf life •T 5diff Fix (date printed on r Preserves the white blood cells in their the container)* native state r Stains the granules of eosinophils,...
  • Page 32 GETTING TO KNOW YOUR INSTRUMENT REAGENTS AND INSTRUMENT WASTE Note: Service trainers may want to demonstrate updating Reagent information as they install the reagents. The Reagent Status screen shows the percent of each reagent left, based on the number of cycles done since the reagent counter was reset. Double-clicking a reagent level displays the Reagent screen for that reagent.
  • Page 33 GETTING TO KNOW YOUR INSTRUMENT REAGENTS AND INSTRUMENT WASTE To view the selection, from the Main Menu click tab. General Reagents can be primed manually. Manual priming needs to be done if automatic priming does not completely fill the lines with reagent (such as during the initial installation of the instrument) or if an instrument problem introduces air into the reagent lines.
  • Page 34 GETTING TO KNOW YOUR INSTRUMENT REAGENTS AND INSTRUMENT WASTE If the waste container is ready for replacement, have the trainee use this procedure to replace the container. Make sure the trainee continues the procedure to the end, which includes doing the procedure under Neutralizing the Waste and Treating for Biohazards Heading 11.4, WASTE...
  • Page 35 STARTUP / SHUTDOWN STARTUP PROCEDURE A Objectives When you have completed this topic you will be able to: B Explain the difference between a Startup procedure and a Startup cycle. B Start up the instrument following the recommended Startup procedure. B Recognize out-of-limit Startup results.
  • Page 36 STARTUP / SHUTDOWN STARTUP PROCEDURE The Startup results are reported as Passed (which indicates that all checks passed the limits) or Failed. When run at the beginning of a New Workday, checks for sufficient reagent volume to complete the Daily Workload. The reagent volumes needed for the Daily workload is based on the typical CBC/DIFF and CBC workload entered into the software as part of setup.
  • Page 37 If one or more parameter results failed: On the Main Menu screen, click to repeat the Startup cycle. If Startup continues to fail, contact your Beckman Coulter Representative. If all the parameter results passed but the Startup status failed: On the Main Menu screen, click to display the Alarms and Errors Log screen.
  • Page 38 Instructions for Use manual and look up the message in the Error table. Complete the suggested action. For more assistance, contact your Beckman Coulter Representative. Always do a Startup cycle: Anytime Rinse reagent has replaced Diluent in the aperture baths (such as after a Shutdown cycle).
  • Page 39 STARTUP / SHUTDOWN AUTO-CLEAN CYCLE From the Main Menu screen, click to initiate the Mini-Clean cycle. Mini-Clean (Running) procedure is located under Heading 11.5 DIAGNOSTICS MENU n the Online Help System or the Instructions for Use manual. SCREEN Whether you need to do a Startup cycle or a Mini-Clean cycle is determined by the state of the instrument at the time you are ready to process patient samples or controls.

  • Page 40: Shutdown

    STARTUP / SHUTDOWN SHUTDOWN PROCEDURE The procedure for setting the frequency of the automatic Auto-Clean cycle is covered under Heading 3.4, SYSTEM SETUP OPTIONS, in this Training Guide. To view the current setting, from the Main Menu screen click Cycle Options tab.
  • Page 41 Heading 6.4 SHUTDOWN the Online Help System or the Instructions for Use manual Point out that Beckman Coulter recommends that the laboratory: Do a Shutdown once every 24 hours that the instrument is in use. Allow the Rinse reagent to remain in the instrument a minimum of 30 minutes to minimize protein buildup in the instrument.

  • Page 42: Procedure

    STARTUP / SHUTDOWN SYSTEM POWER UP PROCEDURE D Topic Notes and Tasks The System Power Down procedure turns off the Workstation and the Analyzer in a specific sequence to avoid damage to the instrument. You must power down the system when opening certain doors and panels on the instrument to prevent personal injury from electric shock.

  • Page 43: System Power Down Procedure

    STARTUP / SHUTDOWN SYSTEM POWER UP PROCEDURE Since the instrument is powered down, the trainee will need either a printed copy of the procedure or a computer near the instrument Powering Up the System and Logging On displaying that procedure. The procedure is located under Heading 5.3 POWERING UP AND in the Instructions for Use manual.

  • Page 44: System Power Up Procedure

    STARTUP / SHUTDOWN SYSTEM POWER UP PROCEDURE 2-10 PN 177196BB...

  • Page 45: Options

    SETUP OPTIONS MISCELLANEOUS (OPERATIONAL) SETUP OPTIONS A Objectives When you have completed this topic, you will be able to: B Describe the setup options available on the Miscellaneous screens. B Set up the eight instrument operations on the General screen: Auto-Numbering, Default Panel, Worklist Match Options, Logs (comment prompts), RUO Parameters, Manual Match, Auto-Stop for QA Messages, and Auto-Stop for Consecutive Results.
  • Page 46 SETUP OPTIONS MISCELLANEOUS (OPERATIONAL) SETUP OPTIONS For auto-numbering to restart on the initial number set on this field, you must select (to erase the previous days Worklist) and Erase Worklist Reset Autonumbering on the Login screen at the beginning of a “New Workday”. Auto-numbering is always on;...
  • Page 47 Enabled - USA You must print and fill out an RUO form and send the completed form to Beckman Coulter as instructed. The @ label precedes the PCT, PDW, ATL and IMM parameters when they are displayed, printed, or transmitted The following message, For Research Use Only.
  • Page 48 SETUP OPTIONS MISCELLANEOUS (OPERATIONAL) SETUP OPTIONS Whenever a XB/XM Failed message (alarm) is triggered, you can elect to stop analysis of patient samples ( Stop instrument on “XB/XM Failed” message Auto-Stop for Consecutive Results The Auto-Stop for Consecutive Results feature allows you to select the number of consecutive results with certain characteristics that, if they occur, automatically stop the instrument.

  • Page 49: Quality Assurance Setup Options

    SETUP OPTIONS QUALITY ASSURANCE SETUP OPTIONS QUALITY ASSURANCE SETUP OPTIONS A Objectives When you have completed this topic, you will be able to: B Describe the options available from the Quality Assurance Options screen. B Explain the advantage of using multiple shifts. B Set up shifts for the laboratory if desired.
  • Page 50 SETUP OPTIONS QUALITY ASSURANCE SETUP OPTIONS XB/XM Options Allow you to enable or disable the XB or XM quality control options. is the default setting. Information about the XB/XM method of monitoring instrument performance is available in the Topic, XB/XM , in Chapter To change the selection see the procedure, XB/XM Options (Enabling/Disabling)

  • Page 51: Auto Functions Setup Options

    SETUP OPTIONS AUTO FUNCTIONS SETUP OPTIONS AUTO FUNCTIONS SETUP OPTIONS A Objectives When you have completed this topic, you will be able to: B Describe the options available from the Auto Functions screen. B Set up the instrument to automatically rerun selected specimens. B Set up the instrument to automatically print selected patient results.
  • Page 52 SETUP OPTIONS AUTO FUNCTIONS SETUP OPTIONS The rerun criteria can be applied to one or all flagging sets. A flagging set is a set of patient limits and action limits selected by the laboratory for a specific group of patients, such as neonates. The flagging sets available are listed in the Flagging Set drop-down menu.

  • Page 53: System Setup Options

    SETUP OPTIONS SYSTEM SETUP OPTIONS SYSTEM SETUP OPTIONS A Objectives When you have completed this topic, you will be able to: B Describe the options available from the System screens. B Set the date and time displayed at the Workstation. B Locate the procedures for changing the Workstation for non-English speaking locations.
  • Page 54 SETUP OPTIONS SYSTEM SETUP OPTIONS The procedure for changing the software language immediately follows the procedure for changing the date and time in Appendix of the Online Help System or the Instructions for Use manual. Click the Host tab. The LIS/HIS communication settings on the Host screens configure the A •T 5diff instrument for communications with (to and from) the laboratory’...
  • Page 55 . The raw values collected during analysis. Raw Data Note: This data can be useful as a troubleshooting tool, but do not enable this option unless instructed by your Beckman Coulter Representative. Microscopic Examination Area . A labeled area where results of the microscopic examination can be added.
  • Page 56 SETUP OPTIONS SYSTEM SETUP OPTIONS The system uses these numbers at the end of Startup to determine if the reagent volume available is sufficient for the workday. If the system determines the reagent volume is insufficient it generates the message, Reagent(s) Low. Insufficient Reagent to Complete Daily Workload. The Daily Workload can be set from 1 to 500 cycles.

  • Page 57: Configuration Save And Restore Setup

    SETUP OPTIONS CONFIGURATION SAVE AND RESTORE SETUP OPTIONS CONFIGURATION SAVE AND RESTORE SETUP OPTIONS A Objectives When you have completed this topic, you will be able to: B Describe the options available from the Config. Save/Restore screen. B Locate the procedures for saving and restoring the Analyzer and Workstation configurations in the Online Help System or the Instructions for Use manual.

  • Page 58: Operators Setup Options

    SETUP OPTIONS OPERATORS SETUP OPTIONS Click the Delete Database tab to display the Delete Database screen. The Delete Database screen allows you to delete all or part of the patient database. Deletion is based on a date selected by the Operator. The calendar on the left allows you to select the run date up to and including which all patient data will be deleted.
  • Page 59 SETUP OPTIONS OPERATORS SETUP OPTIONS Supervisors do not have access to Service function screens. Operators do not have access to Service function screens, Setup screens, or the Calibration screen. The right side of the Operator’ s screen gives the details for the user selected in the Users List and allows Service or a Supervisor to edit, add, or delete users.

  • Page 60: Flagging Sets Setup Options

    SETUP OPTIONS FLAGGING SETS SETUP OPTIONS FLAGGING SETS SETUP OPTIONS A Objectives When you have completed this topic, you will be able to: B Describe the options available from the Flagging Sets screen. B Locate the procedure for editing pre-defined flagging sets. B Locate the procedure for creating a new flagging set.
  • Page 61 IMPORTANT Do not make any adjustments to the flag sensitivities or the thresholds without first consulting your Beckman Coulter Representative. Otherwise, your system may not perform to specifications. Any change to thresholds or sensitivity affect overall system performance. The options in the Flag Sensitivity and Thresholds box are for Service use only.
  • Page 62 SETUP OPTIONS FLAGGING SETS SETUP OPTIONS 3-18 PN 177196BB...

  • Page 63: Setting Up Or Modifying Cell Control

    1 through 12 are reserved for CBC controls. 13 through 24 are reserved for CBC/DIFF controls. Beckman Coulter recommends running all three levels (Low, Normal, and High) of the A •T 5diff Control Plus to monitor the CBC and DIFF parameters.
  • Page 64 QUALITY ASSURANCE SETTING UP OR MODIFYING CELL CONTROL FILES Help the trainee find Heading A.6 SETTING UP A CONTROL FILE, in the Online Help System or the Instructions for Use manual, and set up their control files. If the instrument has the optional Barcode Scanner and the control vials have a bar-code label, demonstrate how to use the Barcode Scanner correctly.

  • Page 65: Analyzing Cell Controls

    Accurate control results depend not only on the instrument condition but also on the stability of the control material itself and how it is stored and handled. Beckman Coulter recommends COULTER A •T 5diff CONTROL PLUS (low, normal, and high) as a stable reference control for use with this instrument.
  • Page 66 QUALITY ASSURANCE ANALYZING CELL CONTROLS Make sure the trainee is aware of the following: Open-vial stability is listed according to days or events. An event has occurred anytime an Operator completes the following sequence: Removes a control vial from the refrigerator Allows the control vial to stand at room temperature 15 minutes Mixes the control vial gently by hand using the 8 x 8 x 8 method two times d) Aspirates sample...
  • Page 67 QUALITY ASSURANCE ANALYZING CELL CONTROLS Cell controls are run in the Autoloader mode using the same positive ID as the patient samples. From the Main menu, click tab to determine which General positive ID method, Barcode Cass./Position , the laboratory is setup to use. If the laboratory has Barcode selected, the trainee should use the...
  • Page 68 QUALITY ASSURANCE ANALYZING CELL CONTROLS For a detailed description of the QC Graphics screen, refer to Understanding the under H In the Online QC Graphics Screen, eading 7.3 RUNNING CELL CONTROLS Help System or the Instructions for Use manual From the Main Menu, click to display the QC screen and explain the screen elements of the QC screens.
  • Page 69 QUALITY ASSURANCE ANALYZING CELL CONTROLS An R, V, or S against a red background indicates two flags were generated, the R, V, or S shown and an H or L not shown but indicated by the red. If the instrument determines a control run had an analytical error, the control run is rejected.
  • Page 70 QUALITY ASSURANCE ANALYZING CELL CONTROLS If any of the control results are outside the expected range, it could be a control problem, a statistical outlier, or an instrument problem. Review the logic outlined under Heading 4.3, INTERPRETING AND USING CELL CONTROL DATA in this Training Guide to correct the problem.

  • Page 71: Interpreting And Using Cell Control

    QUALITY ASSURANCE INTERPRETING AND USING CELL CONTROL DATA INTERPRETING AND USING CELL CONTROL DATA A Objectives When you have completed this topic, you will be able to: B Explain the statistics associated with the control files and graphs. B Review numeric and graphic control data for errors and make appropriate corrections. B Establish running means and expected ranges for parameters without assay values or for which you want to use your own values and ranges.

  • Page 72: Quality Assurance,

    If the trainee needs more basic information on quality assurance, suggest Basic Concepts of Quality Control, PN 4235526, as a reference. Contact your Beckman Coulter Representative to order a printed copy. This book is designed for someone with little or no quality assurance experience.
  • Page 73 Delete the out of limit results and keep the new results. Run other control levels that need to be processed. Resume normal operation. You are ready to analyze patient samples. If the results are still out, call your Beckman Coulter Representative to help you troubleshoot. 4-11...
  • Page 74 QUALITY ASSURANCE INTERPRETING AND USING CELL CONTROL DATA USE GRAPHS TO DETECT PROBLEMS AND POINT TO SOLUTIONS Trend r A trend is a gradual change in five or more consecutive results, all going upward or all going downward. r Systematic drift or trend in control values suggests that a problem is progressively developing.

  • Page 75: Control Data Management

    QUALITY ASSURANCE CONTROL DATA MANAGEMENT CONTROL DATA MANAGEMENT A Objectives When you have completed this topic, you will be able to: B Print control file data. B Exclude individual control runs. B Delete a control file. B References In the Online Help System or the Instructions for Use manual, refer to: Printing/Transmitting Saved Cell Control Results under Heading 7.3 RUNNING CELL...

  • Page 76: Interlaboratory Quality Assurance

    QUALITY ASSURANCE INTERLABORATORY QUALITY ASSURANCE (IQAP) INTERLABORATORY QUALITY ASSURANCE (IQAP) A Objectives When you have completed this topic, you will be able to: B Explain the purpose of the Interlaboratory Quality Assurance Program (IQAP). B References In the Online Help System or the Instructions for Use manual, refer to: IQAP ID (Entering/Editing) under Appendix A.5 QUALITY ASSURANCE SETUP.

  • Page 77: Reproducibility And Carryover

    QUALITY ASSURANCE REPRODUCIBILITY AND CARRYOVER CHECKS REPRODUCIBILITY AND CARRYOVER CHECKS A Objectives When you have completed this topic, you will be able to: B Explain the purpose of a reproducibility check. B Locate the procedure for running a reproducibility study in the Manual mode. B Locate the procedure for running a reproducibility study in the Automatic mode.
  • Page 78 QUALITY ASSURANCE REPRODUCIBILITY AND CARRYOVER CHECKS Three tubes of the same normal, fresh whole-blood specimen, each cycled at least seven times, are needed to meet the 20 sample requirement. When using the software to do a reproducibility check, the instrument calculates the mean and CV for each parameter.

  • Page 79: Setting Up Xb/Xm

    QUALITY ASSURANCE SETTING UP XB/XM SETTING UP XB/XM A Objectives When you have completed this topic, you will be able to: B Explain the purpose of XM analysis. B Explain why the use of RBC indices is so effective in the XM analysis. B Locate the procedures for Setting up the XB/XM Quality Assurance option.
  • Page 80 QUALITY ASSURANCE SETTING UP XB/XM Concept of this analysis is based on X Analysis developed by Dr. Brian Bull but is modified so you can elect to use additional parameters. The traditional three parameter analysis focuses on the stable RBC indices: MCV, MCH, and MCHC.
  • Page 81 QUALITY ASSURANCE SETTING UP XB/XM When using XB/XM, you can elect to have the instrument stop analyzing patient samples when a XB/XM Failed message (alarm) is generated. Selecting Auto-Stop for a XB/XM Failed message is covered under Heading 3.1, MISCELLANEOUS (OPERATIONAL) SETUP OPTIONS, in this Training Guide.

  • Page 82: Interpreting And Using The Xb/Xm

    QUALITY ASSURANCE INTERPRETING AND USING THE XB/XM DATA For the remaining six of the Nine-Parameter XM Analysis Your laboratory must evaluate the results of your population and decide what represents an acceptable mean value for each parameter to begin establishing the XM mean values for your patient population Due to the wide physiological range for the other six parameter, you may wish to use a higher percent limit than you use for the MCV, MCH, and MCHC parameters.
  • Page 83 QUALITY ASSURANCE INTERPRETING AND USING THE XB/XM DATA Does an XB/XM analysis at regular intervals on sets (batches) of 20 patient results, determining the batch mean of each parameter. The calculation is done automatically. This batch mean is not a simple average value of the patients’ parameter results, but a type of “weighted moving average”...
  • Page 84 QUALITY ASSURANCE INTERPRETING AND USING THE XB/XM DATA d) This data can be used to identify affected parameters and to determine the direction and amount of the change. If batch means are below the acceptable limits they are displayed in yellow. If batch means are above the acceptable limits they are displayed in red.
  • Page 85 Can be a gradual change caused by a calibration drift or a component going bad over time. Can be a sudden change caused by a component failure. After the instrument problem is corrected, the XB/XM results should come back within limits. Call your Beckman Coulter Representative for assistance if necessary. 4-23 PN 177196BB...
  • Page 86 QUALITY ASSURANCE INTERPRETING AND USING THE XB/XM DATA 4-24 PN 177196BB...

  • Page 87: Calibration Overview

    After a major analytical component, such as the sampling syringe or an aperture, is replaced. If your Beckman Coulter Representative suggests you calibrate. If, in the normal process of tracking data for an extended period of time, your laboratory makes a specific decision to recalibrate a given parameter. This data can include cell control files, XB/XM batch files, and IQAP reports.

  • Page 88: Preliminary Calibration

    CALIBRATION PRELIMINARY CALIBRATION CHECKS/PROCEDURES PRELIMINARY CALIBRATION CHECKS/PROCEDURES A Objectives When you have completed this topic, you will be able to: B Do the preliminary calibration checks and procedures. B References In the Online Help System or the Instructions for Use manual, refer to Heading 10.2 PRE-CALIBRATION CHECKS C Special Instructions...

  • Page 89: Auto-Calibration

    CALIBRATION AUTO-CALIBRATION AUTO-CALIBRATION A Objectives When you have completed this topic, you will be able to: B Calibrate the instrument using the Auto-Calibration procedure outlined in the Online Help System or the Instructions for Use manual. B Demonstrate how to access the Calibration Log. B References In the Online Help System or the Instructions for Use manual, refer to: Heading 10.1 GENERAL...
  • Page 90 CALIBRATION AUTO-CALIBRATION The right side of the Calibration screen displays the calibration data in tables. The upper table displays the results of the calibration runs. The lower table displays the calibration statistics. As you review the Calibration screen elements, ensure the trainee understands the following terms: 1.

  • Page 91: Calibration

    The minimum results needed is based on the Minimum Runs for Automatic Calibration setting on the Quality Assurance setup options screen. Beckman Coulter recommends calibration factors based on a minimum of five acceptable results. The Operator can elect to “force” calibration, that is to calibrate even if results are outside limits.

  • Page 92: Analysis

    CALIBRATION AUTO-CALIBRATION If Auto-Print for Calibration Results is selected on the System setup screens, the calibration results are automatically printed. To view/change the current Autoprint setting for calibration, from the Main Menu click tab. Printer Calibration results are not transmitted to the Host computer. 10.
  • Page 93 CALIBRATION MANUAL CALIBRATION MANUAL CALIBRATION A Objectives When you have completed this topic, you will be able to: B Locate the Manual Calibration procedure in the Online Help System or the Instructions for Use manual. B Name a reason for doing a manual calibration. B Locate the software screen for manually entering calibration factors.
  • Page 94 The procedure for entering manual calibration factors, Edit/Accept Calibration Factors, is under Heading 11.6 DIAGNOSTICS USER SCREEN, Others (Diagnostic Functions), in Online Help System or the Instructions for Use manual The Operator should contact their Beckman Coulter Representative if there are questions. PN 177196BB...
  • Page 95 SAMPLE ANALYSIS SPECIMEN HANDLING A Objectives When you have completed this topic, you will be able to: B Locate the approved tube list. B State the recommended anticoagulant to use for specimens processed on an •T 5diff AL hematology analyzer. B State the minimum volume of blood needed for processing a specimen.
  • Page 96 SAMPLE ANALYSIS SPECIMEN HANDLING The type of cap (pierceable or not) on the specimen tube/micro-collection device dictates whether a sample can be run closed-vial or must be run open-vial. Closed-vial sampling is recommended for evacuated collection tubes and control vials with pierceable stoppers or caps. Samples can be run in either the Autoloader or the Manual mode.

  • Page 97: Identification

    SAMPLE ANALYSIS SAMPLE IDENTIFICATION SAMPLE IDENTIFICATION A Objectives When you have completed this topic, you will be able to: B State three options for entering/assigning a Sample ID in the Manual mode. B State four options for entering/assigning a Sample ID in the Autoloader mode. B Explain the auto-numbering feature and state when it is used.
  • Page 98 SAMPLE ANALYSIS SAMPLE IDENTIFICATION In the Manual mode a Sample ID must be assigned before you can initiate the cycle. You can enter a Sample ID in the Sample ID field on the Manual Mode screen. You can leave the Sample ID field blank and let the instrument assign an AUTO_SID.

  • Page 99: Sample Analysis,

    SAMPLE ANALYSIS SAMPLE IDENTIFICATION In the Autoloader mode, because you have an internal bar-code reader to identify the sample (if it has a barcode label) and the cassette, you can initiate a cycle without entering a Sample ID. If a Sample ID is not preassigned to a sample via a Worklist, or if the instrument cannot find or read the bar-code label on the specimen tube, the instrument automatically assigns an auto-numbered Sample ID to that specimen.

  • Page 100: Patient/Sample Information

    Appendix B, BARCODE of the Online Help System or the SPECIFICATIONS FOR OPTIONAL BARCODE WAND, Instructions for Use manual. The Barcode Scanner is installed and set up by your Beckman Coulter Representative. PATIENT/SAMPLE INFORMATION A Objectives When you have completed this topic, you will be able to: B State the three pieces of sample information required for every sample processed.

  • Page 101: Sample Identification,

    SAMPLE ANALYSIS PATIENT/SAMPLE INFORMATION Heading A.10 FLAGGING SETS SETUP. Heading 8.8 UNDERSTANDING THE WORKLIST SCREENS C Special Instructions The instrument must be powered up. Either a Supervisor or Service must be logged in to view Setup options, but this is optional and is not required for covering the essential information in this topic.
  • Page 102 SAMPLE ANALYSIS PATIENT/SAMPLE INFORMATION When making entries on this screen, clicking alternates the test panel between CBC and CBC/DIFF. Click to exit the Manual Mode screen. If a test panel is not preselected for a sample, the instrument uses the default setting. The procedure for changing this setting, , is Default Panel (Selecting CBC or CBC/DIFF)
  • Page 103 SAMPLE ANALYSIS PATIENT/SAMPLE INFORMATION HH flag appears to the right of the result that is above the upper limit. A red background accompanies the flag. d) May also generate an interpretive message Flagging set limits can also be used as a criteria for the instrument to do an automatic rerun.
  • Page 104 SAMPLE ANALYSIS PATIENT/SAMPLE INFORMATION FLAGGING SET HIERARCHY Start Current Flagging set= Default Flagging Set? Current Flagging set based on Age or Gender ≤ 14yr Gender available Select child range Flagging set remains as Woman selected 7367518B 10. If a flagging set is not selected for a sample and either a Worklist is not used or a Worklist is used but the patient’...
  • Page 105 SAMPLE ANALYSIS PATIENT/SAMPLE INFORMATION Demographics include patient name, age, date of birth, gender, clinic location, physician, and comments. The demographics are saved with the sample and printed or transmitted as part of the full patient report. If the Host transmission protocol is established, demographics are automatically downloaded from the Host computer.

  • Page 106: Workflow Options

    SAMPLE ANALYSIS WORKFLOW OPTIONS WORKFLOW OPTIONS A Objectives When you have completed this topic, you will be able to: B State the preferred method for identifying a sample in the Autoloader mode. B Define a Worklist and state two reasons why your laboratory may want to use one. B Explain the reason for using the Manual Match option with a Worklist.

  • Page 107: Matches

    SAMPLE ANALYSIS WORKFLOW OPTIONS The laboratory chooses which positive ID, Barcode Cass./Position , to use and the instrument is set up for that at installation. The default setting is Barcode The procedure for selecting the positive ID, , is Worklist Match and Manual Match Options under , in the Online Help System or the Instructions Heading A.4 OPERATIONAL SETUP...
  • Page 108 SAMPLE ANALYSIS SAMPLE ANALYSIS IN THE AUTOLOADER MODE SAMPLE ANALYSIS IN THE AUTOLOADER MODE A Objectives When you have completed this topic, you will be able to: B Demonstrate the correct way to load and unload cassettes with specimen tubes, and load and unload the Autoloader with cassettes.
  • Page 109 SAMPLE ANALYSIS SAMPLE ANALYSIS IN THE AUTOLOADER MODE Worklist: Barcode Positive ID, Manual Match ON This is the preferred method as it provides the strongest and most reliable link between the sample results and the specimen. The specimen is identified by a label attached directly to it, the work order is entered using the identification from that label, the instrument reads that label when it analyzes the sample, and then the instrument matches the sample results with the information entered for the specimen with that label.
  • Page 110 SAMPLE ANALYSIS SAMPLE ANALYSIS IN THE MANUAL MODE SAMPLE ANALYSIS IN THE MANUAL MODE A Objectives When you have completed this topic, you will be able to: B State three circumstances under which you would use the Manual mode for processing a sample instead of the Autoloader mode.
  • Page 111 SAMPLE ANALYSIS SAMPLE ANALYSIS IN THE MANUAL MODE After a Sample ID is entered for the specimen tube, the specimen tube is loaded into the correct tube holder for the specimen tube or micro collection device and the tube holder is placed into the correct position for sampling. If necessary, review/demonstrate the correct technique for loading a specimen tube into the tube holder and positioning the tube holder for sampling.
  • Page 112 SAMPLE ANALYSIS RUN-IN-PROGRESS, RESULTS LIST, AND RESULTS SCREENS RUN-IN-PROGRESS, RESULTS LIST, AND RESULTS SCREENS A Objectives When you have completed this topic, you will be able to: B Display both a Run-in-Progress screen and a Results screen. B State the types of information found on both the Run-in-Progress and Results screens. B State four features that are available on the Results screen but that are not available on the Run-in-Progress screen.
  • Page 113 SAMPLE ANALYSIS RUN-IN-PROGRESS, RESULTS LIST, AND RESULTS SCREENS The fields on the left side of the Run-in-Progress screen give you sample information. The following fields are always filled: Sample ID Cassette and Position Number (Test) Panel Flagging Set Run Date and Time Gender (displayed as if a specific gender is not entered on a Worklist).

  • Page 114: Mode

    SAMPLE ANALYSIS RUN-IN-PROGRESS, RESULTS LIST, AND RESULTS SCREENS The Flags and Messages area on the far right of the Run-in-Progress screen displays messages generated by the instrument to help you evaluate the sample results. The Flags and Messages area can display flags and messages for QC, calibration, and reproducibility samples in addition to patient samples.
  • Page 115 SAMPLE ANALYSIS RUN-IN-PROGRESS, RESULTS LIST, AND RESULTS SCREENS Results List Screen After a sample is analyzed and its results are matched with its order, the results and any other sample information is posted to the Results List screen. Click to display the Results List screen. The Results List screen lists the results of all the samples that are either ready to be reported or that have been reported, but that have not been archived.

  • Page 116: Screens,

    SAMPLE ANALYSIS RUN-IN-PROGRESS, RESULTS LIST, AND RESULTS SCREENS You can access the Match screen from the Results List screen. Click to display the Match screen, then click to exit the screen. Manual matching is discussed under Heading 6.9, MANUAL MATCHES, in this section of the Training Guide.

  • Page 117: Reruns,

    SAMPLE ANALYSIS AUTOMATIC AND MANUAL SPECIMEN RERUNS AUTOMATIC AND MANUAL SPECIMEN RERUNS A Objectives When you have completed this topic, you will be able to: B Locate the procedure for rerunning samples in the Online Help System or the Instructions for Use manual. B References In the Online Help System or the Instructions for Use manual, refer to: Heading 8.6 RE-RUNNING SAMPLES...
  • Page 118 SAMPLE ANALYSIS MANUAL MATCHES MANUAL MATCHES A Objectives When you have completed this topic, you will be able to: B List three circumstances under which the instrument may not be able to match sample results to the order. B State why the Manual Match option should be used when you are using a Worklist. B State why the Manual Match option should not be used if you are not using a Worklist.
  • Page 119 SAMPLE ANALYSIS MANUAL MATCHES The instrument reports the sample as it is analyzed. If the Sample ID is unknown it assigns an AUTO_SID number. Even if Manual Match is OFF (disabled), the sample results are posted to the Match screen if the positive ID is set to (so a barcode Sample ID is expected) and the Barcode instrument does not obtain a barcode reading from the specimen tube.
  • Page 120 SAMPLE ANALYSIS MANUAL MATCHES 6-26 PN 177196BB...

  • Page 121: Data Management And Review

    DATA MANAGEMENT AND REVIEW DATA MANAGEMENT A Objectives When you have completed this topic, you will be able to: B Describe what type of results are stored in the database and how many results it hold. B State the data management options offered at the beginning of a New Workday. B Demonstrate how to search for the results of a specific sample.
  • Page 122 DATA MANAGEMENT AND REVIEW DATA MANAGEMENT The database can store 10,000 results. After 10,000 results have been stored, the system automatically deletes the oldest results having the oldest activity by Sample ID, leaving a maximum of 9,500 results. After the results are deleted, the system compacts the database to allow additional results to be stored.

  • Page 123: Data Analysis - An Overview Of The Dilutions And Measurements

    DATA MANAGEMENT AND REVIEW DATA ANALYSIS - AN OVERVIEW OF THE DILUTIONS AND MEASUREMENTS DATA ANALYSIS - AN OVERVIEW OF THE DILUTIONS AND MEASUREMENTS A Objectives When you have completed this topic, you will be able to: B State the parameters derived from the dilutions made in each bath. B Briefly explain the sequential dilution system (SDS) B References Bulletin 9151: A...
  • Page 124 DATA MANAGEMENT AND REVIEW DATA ANALYSIS - AN OVERVIEW OF THE DILUTIONS AND MEASUREMENTS CBC Panel - CBC/DIFF Panel - Sample Partitions inside Probe Sample Partitions inside Probe Diluent Diluent Air bubble Air bubble Not used DIFF dilution Not used WBC/BASO dilution WBC/BASO dilution RBC/PLT/HGB first dilution...
  • Page 125 DATA MANAGEMENT AND REVIEW DATA ANALYSIS - AN OVERVIEW OF THE DILUTIONS AND MEASUREMENTS Dilution Used to Determine RBC and PLT Results The dilution made in the RBC bath is used to analyze red blood cells and platelets. The RBC bath dilution is prepared in two stages: Primary dilution: 10 µL whole-blood is diluted with 1.7 mL of Diluent in the DIL1/HGB bath to form a 1:170 dilution (commonly referred to as first dilution) Secondary dilution: 42.5 µL of this first dilution is transferred to the RBC bath...
  • Page 126 DATA MANAGEMENT AND REVIEW DATA ANALYSIS - AN OVERVIEW OF THE DILUTIONS AND MEASUREMENTS Dilution Used to Determine the Hemoglobin Result The final dilution made in the DIL1/HGB bath is used to determine the hemoglobin parameter result. The final dilution in the DIL1/HGB bath is prepared in three stages: Primary dilution: 10 µL whole-blood is diluted with 1.7 mL of Diluent in the DIL1/HGB bath to form a 1:170 dilution (commonly referred to as the first dilution) Secondary dilution:...
  • Page 127 DATA MANAGEMENT AND REVIEW DATA ANALYSIS - AN OVERVIEW OF THE DILUTIONS AND MEASUREMENTS Dilution Used to Determine the Reference WBC Count and the BASO Count Two dilutions are required to obtain WBC count and differential parameter results: WBC/BASO dilution DIFF dilution The final dilution in the WBC/BASO bath is used to determine the reference WBC count and the BASO count.
  • Page 128 DATA MANAGEMENT AND REVIEW DATA ANALYSIS - AN OVERVIEW OF THE DILUTIONS AND MEASUREMENTS Dilution Used to Determine LYMPH, MONO, NEUT, and EO Counts and a Secondary WBC Count Two dilutions are required to obtain differential parameter results: WBC/BASO dilution DIFF dilution The final dilution in the DIFF bath is used to determine lymphocytes, monocytes, neutrophils, and eosinophils counts and a secondary WBC count.

  • Page 129: Data Analysis - Measurement Principles

    DATA MANAGEMENT AND REVIEW DATA ANALYSIS - MEASUREMENT PRINCIPLES DATA ANALYSIS - MEASUREMENT PRINCIPLES A Objectives When you have completed this topic, you will be able to: B State the Coulter Principle. B State the relationship of resistance, cell volume, and pulse height. B Define threshold, count periods, and voting.
  • Page 130 DATA MANAGEMENT AND REVIEW DATA ANALYSIS - MEASUREMENT PRINCIPLES The WBC/BASO bath aperture sensor system determines the cell count and size of WBCs. The WBC Lyse specific lytic action on the WBCs in this bath allows the system to further differentiate, by size, the basophils from the rest of the WBCs. Aperture Sensor System Solution to be analyzed Bath electrode...
  • Page 131 DATA MANAGEMENT AND REVIEW DATA ANALYSIS - MEASUREMENT PRINCIPLES Thresholds are used to exclude pulses from unwanted particles, such as debris, from analysis. A threshold is an electronically set size limit. Particles equal to or above the threshold are analyzed and particles below the threshold are excluded.
  • Page 132 DATA MANAGEMENT AND REVIEW DATA ANALYSIS - MEASUREMENT PRINCIPLES V Differential Technology In the AcV Technology, cells are cytochemically treated to preserves WBCs at their original size while differentially staining lymphocytes, monocytes, neutrophils, and eosinophils. The AcV Technology uses both the Coulter principle (to determine the cell volumes of the WBCs) and absorbance readings (to detect the difference in staining characteristics of the WBCs) to obtain data for developing the DiffPlot.
  • Page 133 DATA MANAGEMENT AND REVIEW DATA ANALYSIS - MEASUREMENT PRINCIPLES Absorbance readings are taken on the cytochemically treated WBCs in the optical window of the flow cell. As a cell passes through the optical portion of the flow cell, light is scattered in all directions.
  • Page 134 DATA MANAGEMENT AND REVIEW DATA ANALYSIS - MEASUREMENT PRINCIPLES Typical Absorbance Signals The DiffPlot is developed with optical transmission (absorbance) on the X-axis and volume on the Y-axis DiffPlot used to determine four of five leukocyte (white blood cell) populations: lymphocytes ( ), monocytes ( ), neutrophils (...

  • Page 135: Data Analysis Review - Wbc Parameters

    DATA MANAGEMENT AND REVIEW DATA ANALYSIS REVIEW - WBC PARAMETERS DATA ANALYSIS REVIEW - WBC PARAMETERS A Objectives When you have completed this topic, you will be able to: B List the individual parameters that comprise the WBC Profile. B Identify which parameters in the WBC Profile are directly measured, derived from the WBC/BASO histogram, derived from the DiffPlot, or computed.
  • Page 136 DATA MANAGEMENT AND REVIEW DATA ANALYSIS REVIEW - WBC PARAMETERS When the CBC/DIFF test panel is selected, a second WBC count is analyzed on the DIFF dilution in the flow cell during the acquisition of the DiffPlot. This WBC count is sometimes referred to as the secondary WBC count. This WBC count is compared to the WBC count from the WBC BASO bath and if the difference exceeds a preset limit, the WBC results are flagged.
  • Page 137 DATA MANAGEMENT AND REVIEW DATA ANALYSIS REVIEW - WBC PARAMETERS DiffPlot Development The DiffPlot is developed from analysis of the DIFF dilution made in the DIFF bath. The Fix reagent in the final dilution lyses the RBCs, stabilizes the WBCs, and differentially stains the lymphocytes, monocytes, neutrophils, and eosinophils, with the eosinophils staining most intensely The dilution from the DIFF bath is injected through the flow cell for 15 seconds;...
  • Page 138 DATA MANAGEMENT AND REVIEW DATA ANALYSIS REVIEW - WBC PARAMETERS Table 7.5 WBC Differential Parameter Characteristics NORMAL PARAMETERS PARAMETER CHARACTERISTICS Neutrophils r Neutrophils, with their cytoplasmic granules and segmented nuclei, scatter light according to their morphological complexity r Hypersegmented neutrophil gives an increased optical response when compared to a young neutrophil population r Higher the complexity of the cell, the further to the right they appear in the DiffPlot Lymphocytes...
  • Page 139 DATA MANAGEMENT AND REVIEW DATA ANALYSIS REVIEW - WBC PARAMETERS Immature White Blood Cells on the DiffPlot Blasts, Myelocytes, Promyelocytes Metamyelocytes, Immature Neutrophils Immature Eosinophils Agranular Eosinophils Atypical Neutrophils Monocytes Eosinophils Atypical Lymphs, Blasts Neutrophils Bands Lymphs Abnormal Debris, Lymphs NRBCs, Lyse Resistant RBCs, Plt Aggregates...
  • Page 140 DATA MANAGEMENT AND REVIEW DATA ANALYSIS REVIEW - WBC PARAMETERS Summary Table 7.6 summarizes the WBC parameters generated by the A •T 5diff instrument and how each is derived. For details on the methodologies used, review Heading 2.2 MEASUREMENT PRINCIPLES Heading 2.7 PARAMETER DEVELOPMENT, i n the Online Help System or the Instructions for Use manual...

  • Page 141: Data Analysis Review - Rbc Parameters

    DATA MANAGEMENT AND REVIEW DATA ANALYSIS REVIEW - RBC PARAMETERS DATA ANALYSIS REVIEW - RBC PARAMETERS A Objectives When you have completed this topic, you will be able to: B List the individual parameters that comprise the RBC Profile. B Identify which parameters in the RBC Profile are directly measured, derived from the RBC histogram, or computed.

  • Page 142: Parameters,

    DATA MANAGEMENT AND REVIEW DATA ANALYSIS REVIEW - RBC PARAMETERS If the two counts differ by more than a predefined limit: RBC result is flagged with a voteout V-flag. MCV, MCH, MCHC, and RDW parameters are replaced with ( ..) code.
  • Page 143 DATA MANAGEMENT AND REVIEW DATA ANALYSIS REVIEW - RBC PARAMETERS The following is an example of an RBC histogram with a normal RBC size distribution. 7616036A RDW Determination RDW (Red cell Distribution Width) is an index of the variation or spread in the size of the red blood cells.
  • Page 144 DATA MANAGEMENT AND REVIEW DATA ANALYSIS REVIEW - RBC PARAMETERS RBC Distribution Flags Once an RBC distribution curve is developed, two positions on the distribution curve are located, RBC1 and RBC2. RBC1 RBC2 7616057A Thresholds RBC1 and RBC2 define the MICRO and MACRO regions and are calculated based on standard deviation (SD) of the RBC population.
  • Page 145 DATA MANAGEMENT AND REVIEW DATA ANALYSIS REVIEW - RBC PARAMETERS The system calculates the Hgb using both the blank and sample readings: Hgb result in g/dL represents: absorbance value obtained x calibration factor Hgb displayed and printed as: Hgb = N g/dL If the Hgb blank or Hgb read do not meet certain predefined limits, the following flags are generated: If the Hgb blank value is less than 2.5 Vdc, a reject R-flag occurs on the Hgb value.
  • Page 146 DATA MANAGEMENT AND REVIEW DATA ANALYSIS REVIEW - RBC PARAMETERS Summary Table 7.7 summarizes the RBC parameters generated by the A •T 5diff instrument and how each is derived. For details on the methodologies used, review Heading 2.2 MEASUREMENT PRINCIPLES Heading 2.7 PARAMETER DEVELOPMENT, i n the Online Help System or the Instructions for Use manual...

  • Page 147: Data Analysis Review - Platelet Parameters

    DATA MANAGEMENT AND REVIEW DATA ANALYSIS REVIEW - PLATELET PARAMETERS DATA ANALYSIS REVIEW - PLATELET PARAMETERS A Objectives When you have completed this topic, you will be able to: B List the individual parameters that comprise the PLT Profile. B Identify which parameters in the PLT Profile are directly measured, derived from the Plt histogram, or computed.

  • Page 148: Parameters,

    DATA MANAGEMENT AND REVIEW DATA ANALYSIS REVIEW - PLATELET PARAMETERS Rinse flow is a steady stream of Diluent reagent that flows behind the RBC aperture during sensing periods. Without rinse flow (Figure A), there is a characteristic swirling of the dilution at the outlet of the aperture so that red (or white) cells caught up in these eddies behind the aperture may reenter the sensing zone and produce small pulses that could be counted as platelets.
  • Page 149 DATA MANAGEMENT AND REVIEW DATA ANALYSIS REVIEW - PLATELET PARAMETERS This illustration shows a PLT histogram with a typical platelet size distribution. 25fL The PLT histogram provides the information for determining a helpful descriptor of the platelet population: MPV (Mean Platelet Volume) PDW (Platelet Distribution Width) PLT histogram is also used to determine if a platelet population is typical;...
  • Page 150 DATA MANAGEMENT AND REVIEW DATA ANALYSIS REVIEW - PLATELET PARAMETERS In this example, S1 and S2 are placed so that: 15% of the platelets occur between 2 fL and S1. 15% of the platelets occur between S2 and the variable upper threshold. Note: This threshold is explained under the Detecting Abnormal Platelet Distributions...
  • Page 151 DATA MANAGEMENT AND REVIEW DATA ANALYSIS REVIEW - PLATELET PARAMETERS Microcytic red cells can intrude at the upper end of the histogram. If specimen contains microcytes, the Analyzer may be able to successfully eliminate the influence of this interference by repositioning the variable threshold (25 fL threshold) and excluding the microcytes.
  • Page 152 DATA MANAGEMENT AND REVIEW DATA ANALYSIS REVIEW - PLATELET PARAMETERS THREE HISTOGRAMS WITH INTRUSION ON UPPER END OF PLT DISTRIBUTION Microcytic Interference with a Distinct Valley between 18 fL and 25 fL 1. If intrusion of microcytes creates a valley between the 25 fL and the 18 fL thresholds, the 25 fL threshold is repositioned at the valley to minimize interference to platelet parameter results.

  • Page 153: System Diagnostics And Maintenance

    SYSTEM DIAGNOSTICS AND MAINTENANCE ACCESSING AND IDENTIFYING ANALYZER HARDWARE COMPONENTS A Objectives When you have completed this topic, you will be able to: B Access and identify the main components in the A •T 5diff AL system. B References In the Online Help System or the Instructions for Use manual, refer to: Heading 11.3 REMOVING PANELS/COVERS.
  • Page 154 SYSTEM DIAGNOSTICS AND MAINTENANCE ACCESSING AND IDENTIFYING ANALYZER HARDWARE COMPONENTS The Power Down/Power Up procedures are covered under Heading 2.5, SYSTEM POWER DOWN PROCEDURE, and Heading 2.6, SYSTEM POWER UP PROCEDURE, in this Training Guide. If you have not covered the Power Down/Power Up procedures with the trainee yet, it would be a good idea to do that now.
  • Page 155 SYSTEM DIAGNOSTICS AND MAINTENANCE ACCESSING AND IDENTIFYING ANALYZER HARDWARE COMPONENTS Upper Compartment/Front Cover LEDs Power switch Needle position switches Tube holder Piercing mechanism motor Traverse home Tube detect sensor switch Tube height switch 7616266D Lower Front Compartment Tube holder Cassette Cassette Cassette detection...
  • Page 156 SYSTEM DIAGNOSTICS AND MAINTENANCE ACCESSING AND IDENTIFYING ANALYZER HARDWARE COMPONENTS Right Side and Main Card Compartments Horizontal traverse Traverse card assembly Main Probe home LV20 to LV23 card sensor Vertical traverse assembly Sampling syringe Output area full switch Power Waste syringe 1 supply WBC/BASO LV24 to LV30...
  • Page 157 SYSTEM DIAGNOSTICS AND MAINTENANCE ACCESSING AND IDENTIFYING ANALYZER HARDWARE COMPONENTS Table 8.1 Fluidic and Mechanical Modules/Components Component/Module Functions Bar-code reader (internal) Reads the cassette and specimen tube bar-code labels. Bath enclosure area interlock Prevents the Analyzer from cycling when the right-side panel is removed. Bath enclosure heater Maintains the temperature in the bath enclosure area.
  • Page 158 SYSTEM DIAGNOSTICS AND MAINTENANCE ACCESSING AND IDENTIFYING ANALYZER HARDWARE COMPONENTS Table 8.1 Fluidic and Mechanical Modules/Components (Continued) Component/Module Functions Drain/debubble baths Prevents any contamination from going back into the baths when mixing bubbles are dispensed into the baths. Flow cell Houses and provides path through apertures for DC gain and absorbance measurements.

  • Page 159: Recognizing Normal Instrument Operation - Cycle Description

    SYSTEM DIAGNOSTICS AND MAINTENANCE RECOGNIZING NORMAL INSTRUMENT OPERATION - CYCLE DESCRIPTION Table 8.1 Fluidic and Mechanical Modules/Components (Continued) Component/Module Functions Tube holder Holds the tube in the correct position for piercing. Tube holder detection switches Detects the position of the tube holder, identifying which hole is in the piercing position.
  • Page 160 SYSTEM DIAGNOSTICS AND MAINTENANCE RECOGNIZING NORMAL INSTRUMENT OPERATION - CYCLE DESCRIPTION C Special Instructions The instrument must be powered down and the left- and right-side panels and the top cover must be removed. D Topic Notes and Tasks One important tool for troubleshooting an instrument is being familiar with what the instrument does when it is operating normally.
  • Page 161 SYSTEM DIAGNOSTICS AND MAINTENANCE RECOGNIZING NORMAL INSTRUMENT OPERATION - CYCLE DESCRIPTION Pre-Cycle Instrument Conditions The green LED is glowing indicating the Analyzer is ready. The RINSE bath is empty. The DIL 1/HGB, DIFF , and RBC baths contain clean Diluent. The WBC/BASO bath contains a mixture of Diluent and Rinse reagent.
  • Page 162 SYSTEM DIAGNOSTICS AND MAINTENANCE RECOGNIZING NORMAL INSTRUMENT OPERATION - CYCLE DESCRIPTION Preparing for Sample Processing After the cycle is initiated: The sampling probe moves to the pierce position. The sampling probe move down to the vial, the needle pierces the cap, and the sampling probe moves to the correct level in the vial to aspirate a sample of blood.
  • Page 163 SYSTEM DIAGNOSTICS AND MAINTENANCE RECOGNIZING NORMAL INSTRUMENT OPERATION - CYCLE DESCRIPTION Each aliquotted sample is delivered to its appropriate bath using a tangential flow of reagent which mixes the diluted sample and Probe minimizes viscosity problems. To create this tangential flow: The reagent delivery port is positioned so that reagent is delivered tangentially to the wall of the bath, that is the reagent flows...
  • Page 164 SYSTEM DIAGNOSTICS AND MAINTENANCE RECOGNIZING NORMAL INSTRUMENT OPERATION - CYCLE DESCRIPTION Making the WBC/BASO Dilution The horizontal traverse assembly positions the sampling probe over the WBC/BASO bath. The vertical traverse assembly moves the probe downward into the bath. The tip of the probe is positioned so that a tangential flow can occur.
  • Page 165 SYSTEM DIAGNOSTICS AND MAINTENANCE RECOGNIZING NORMAL INSTRUMENT OPERATION - CYCLE DESCRIPTION Double Rinsing the Sampling Probe The horizontal traverse assembly moves the sampling probe over the RINSE bath. A double rinsing (interior and exterior) of the probe removes residual whole-blood sample from inside the probe.
  • Page 166 SYSTEM DIAGNOSTICS AND MAINTENANCE RECOGNIZING NORMAL INSTRUMENT OPERATION - CYCLE DESCRIPTION Making the Hgb Dilution The vertical traverse assembly moves the probe up, out of the dilution in the bath. While the probe is still inside the DIL 1/HGB bath, an additional 0.4 mL of Diluent is added to the bath through the reagent port.
  • Page 167 SYSTEM DIAGNOSTICS AND MAINTENANCE RECOGNIZING NORMAL INSTRUMENT OPERATION - CYCLE DESCRIPTION Rinsing the Baths After analysis of the dilution in the WBC/BASO bath, the horizontal traverse assembly moves to the WBC/BASO bath and the WBC/BASO bath is drained. The sampling probe is rinsed with Diluent and Rinse reagent (cleaning agent) is delivered into the WBC/BASO bath.

  • Page 168: Basic Troubleshooting Techniques

    SYSTEM DIAGNOSTICS AND MAINTENANCE BASIC TROUBLESHOOTING TECHNIQUES BASIC TROUBLESHOOTING TECHNIQUES A Objectives When you have completed this topic, you will be able to: B Recognize an instrument problem based on abnormal sample results. B Recognize an instrument problem based on abnormal Startup results. B Recognize an instrument problem based on abnormal control results.
  • Page 169 Acquire the knowledge and skills necessary to locate and correct problems. Use the instrument Read the manuals and become familiar with the kind of information they contain Call your Beckman Coulter Representative Troubleshooting through Cycle Observation To successfully troubleshoot this instrument, you must: Become completely familiar with normal sample flow.
  • Page 170 SYSTEM DIAGNOSTICS AND MAINTENANCE BASIC TROUBLESHOOTING TECHNIQUES Electronic Subsystem If there is no power: Check to see if one of the indicator lights is on. Check power switches. Check plug connections. If the flow cell lamp is burned out, replace it. Refer to Heading 11.11 REPLACEMENT PROCEDURES , in the Online Help System or the Instructions for Use manual.

  • Page 171: System Message Tables And Other Troubleshooting Tools

    SYSTEM DIAGNOSTICS AND MAINTENANCE SYSTEM MESSAGE TABLES AND OTHER TROUBLESHOOTING TOOLS Pressure. Used for dispensing reagents from pumps, opening pinch valves, and moving air cylinder shafts. Troubleshooting Using System Messages, Special Procedures, and System Diagnostics This information is covered as a separate topic, Heading 8.4, SYSTEM MESSAGE TABLES AND OTHER TROUBLESHOOTING TOOLS, next in this section of the Training Guide.
  • Page 172 SYSTEM DIAGNOSTICS AND MAINTENANCE SYSTEM MESSAGE TABLES AND OTHER TROUBLESHOOTING TOOLS The log entry includes the date and time of the event, the name of the Operator logged in, and the name of the error message posted. The Alarms and Errors log saves entries for up to one year. Prior entries to the log are deleted on a “first in, first out”...
  • Page 173 SYSTEM DIAGNOSTICS AND MAINTENANCE SYSTEM MESSAGE TABLES AND OTHER TROUBLESHOOTING TOOLS Click Hardware Reset You can hear the instrument as it resets components to a “home” position. The status bar at the bottom of the screen displays Hardware Reset while the reset is in progress.

  • Page 174: Preventive Maintenance

    SYSTEM DIAGNOSTICS AND MAINTENANCE PREVENTIVE MAINTENANCE PREVENTIVE MAINTENANCE A Objectives When you have completed this topic, you will be able to: B Name the maintenance procedures required and state how often they must be done. B Demonstrate how to access the Maintenance log. B Locate the procedure for making an entry in the Maintenance log.

  • Page 175: Summary And Quick Reference Masters

    SUMMARY AND QUICK REFERENCE MASTERS SUMMARY PAGES What Are Summary Pages? A summary page contains an abbreviated version of essential operating instructions detailed in the On-Line Help system and the Instructions for Use manual. Purpose Each summary page in this section is an individual, stand-alone document that can be copied for use in the laboratory as a training aid for new Operators and as a quick reference tool for trained Operators while operating the instrument.
  • Page 176 SUMMARY AND QUICK REFERENCE MASTERS CONTENTS In an electronic Training Guide you can use the following links to access the .pdf file of a summary page or a quick reference page master. Summary Page Masters CONTROL ANALYSIS SUMMARY CONTROL DATA MANAGEMENT SUMMARY CONTROL FILE SETUP AND MODIFICATION SUMMARY ONLINE HELP SYSTEM REAGENT REPLACEMENT SUMMARY...

  • Page 177: Training Checklist

    Both the trainer and the trainee should sign the Training Checklist. CHECKLIST INSTALLATION B Verify that the instrument was installed by a Beckman Coulter Representative according to the instructions in the Service manual. B Verify that the instrument is accessible to the Service Representative.
  • Page 178 TRAINING CHECKLIST CHECKLIST GENERAL B Describe the intended use of the instrument, including the parameters reported. B Demonstrate how to access and use Online Help. B Demonstrate how to view the video procedures. B Demonstrate how to view and print the Instructions for Use, Host Transmission Specification, and this Training Guide from the Online Help System.
  • Page 179 TRAINING CHECKLIST CHECKLIST REAGENTS Identify and locate each reagent. •T 5diff Diluent •T 5diff WBC Lyse •T 5diff Hgb Lyse •T 5diff Fix •T 5diff Rinse Comments: _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ GETTING STARTED B Discuss and do the Power Up procedure. B Discuss and do the Power Down procedure.
  • Page 180 TRAINING CHECKLIST CHECKLIST CALIBRATION B Review recommendations and frequency. B Review the package insert. B Do the precalibration checks. B Demonstrate the Diskette download. B Explain the calibration procedure and guide the trainee through it. B Review the manual method of obtaining and entering calibration factors. Comments: _____________________________________________________________________________ _____________________________________________________________________________...
  • Page 181 TRAINING CHECKLIST CHECKLIST SAMPLE ANALYSIS B Discuss worklist options. B Discuss the workflow options available and do the workflow setup (refer to scenarios). B Run patient samples in the Autoloader mode. B Run patient samples in the Manual mode. Comments: _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________...
  • Page 182 TRAINING CHECKLIST CHECKLIST B Cleaning procedures B Reagent container replacement B Waste container replacement B Lamp replacement B Rinse drain filter replacement Comments: _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ MAINTAINING AND SERVICING THE INSTRUMENT B Discuss the importance of “general maintenance”. B Discuss telephone troubleshooting availability and its importance for minimizing downtime.
  • Page 183 TRAINING CHECKLIST CHECKLIST Quality Assurance Setup B Shifts B Quality Assurance Settings Comments: _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ Auto Functions Setup B Rerun B Auto-Print (patient samples results) B Auto-Transmit (patient samples results) Comments: _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ System Setup B Local Settings (time, date, and language) B Host Communications B Printer Characteristics (driver, paper-size, and print quality) B Auto-Print (quality control, reproducibility, calibration, or startup results)
  • Page 184 B Complete this Training Checklist. Place the original in the Laboratory Log book. The Beckman Coulter Representative should Fax a copy of the signed training checklist to: Miami Education Center (305) 380-5022. B Complete a Training Checklist for each operator trained on the instrument.

  • Page 185: Trademarks

    TRADEMARKS Beckman Coulter, the stylized logo, and COULTER are trademarks of Beckman Coulter, Inc. and are registered with the USPTO. All other trademarks, service marks, products, or services are trademarks or registered trademarks of their respective holders. Find us on the World Wide Web at: www.beckmancoulter.com...
  • Page 186 PN 4277065 Training Guide Training information for using the AL system. PN 177196 Hematology Tube List Tube List information PN A70017 Come visit us at www.beckmancoulter.com Printed on Recycled Paper Copyright © Beckman Coulter, Inc. 2002 - 2012 All Rights Reserved...

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