Page 1 COULTER HmX Hematology Analyzer COULTER HmX Hematology Analyzer with Autoloader Operator’s Training Guide ECKMAN OULTER ECKMAN OULTER ® ® PN 4237530BB (March 2011) Beckman Coulter, Inc. 250 S. Kraemer Blvd. Brea, CA 92821...
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: Revision Status
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 4237530BB...
Page 5: Table Of Contents
CONTENTS LEGAL NOTICES REVISION STATUS, iii CONTENTS, v INTRODUCTION, vii GETTING TO KNOW YOUR INSTRUMENT, 1-1 STARTUP / SHUTDOWN, 2-1 SET UP OPTIONS, 3-1 QUALITY CONTROL, 4-1 CALIBRATION, 5-1 SAMPLE ANALYSIS, 6-1 DATA REVIEW, 7-1 BASIC TROUBLESHOOTING, 8-1 SUMMARY PAGES TRAINING CHECKLIST TRADEMARKS PN 4237530BB...
Page 6: Contents
CONTENTS PN 4237530BB...
Page 7: Introduction
INTRODUCTION PURPOSE OF THIS DOCUMENT To provide an authorized trainer with corporately accepted training materials for instructing a new operator in the proper use and operation of a COULTER HmX Hematology Analyzer with Autoloader or a HmX Hematology Analyzer. DOCUMENTATION Several manuals and related documents are shipped with a new instrument.
Page 8 INTRODUCTION ABOUT THIS TRAINING GUIDE ABOUT THIS TRAINING GUIDE Scope This training guide provides the trainer with the opportunity to customize the training experience to best fit the individual trainee and laboratory. Since trainee experience levels and laboratory needs differ, this training outline is designed with flexibility in mind. This document is designed to support both HmX Hematology Analyzer with Autoloader and HmX Hematology Analyzer training.
Page 9 RESPONSIBILITIES Beckman Coulter’s Responsibility Beckman Coulter is responsible for instructing a Key Operator in the proper use and operation of a COULTER HmX Hematology Analyzer with Autoloader or a HmX Hematology Analyzer. Our goal is to provide your laboratory with high quality training that best fits your laboratory’...
Page 10 INTRODUCTION CONVENTIONS CONVENTIONS This training guide uses the following conventions: Italics font indicates screen text and/or messages displayed by the instrument such as RESET THE SYSTEM or Press any key. Note (in bold font) prefaces information that is important to remember or helpful in performing a procedure.
Page 11: Getting To Know Your Instrument
GETTING TO KNOW YOUR INSTRUMENT OBJECTIVES When the subject is complete, you will be able to . . . Data Management System (DMS) Locate and name the three major components of the peripheral computer system. Locate and explain the function of specific keys on the keyboard. Quickly access a commonly used area of software using the Access screen.
Page 12 QUERY WORKLIST WORKLIST MENU This program is protected by U.S. and International laws as described in the manual. (C) Copyright Beckman Coulter Inc., 1999 SELECT FUNCTION 02/28/99 10:14 First screen to appear after a system reset or power up Screen provides operator with quick access to the most commonly used areas of the...
Page 13 GETTING TO KNOW YOUR INSTRUMENT SOFTWARE MENU TREE - HmX Hematology Analyzer with Autoloader SOFTWARE MENU TREE - HmX Hematology Analyzer with Autoloader Sample Analysis Controls Diluter Functions Special Functions Multiple Aperture Zap Workload recording Prime Reagents Run Samples Diagnostics Control Run Compressor On/Off Operator options...
Page 14 GETTING TO KNOW YOUR INSTRUMENT SOFTWARE MENU TREE - HmX Hematology Analyzer SOFTWARE MENU TREE - HmX Hematology Analyzer Sample Analysis Controls Diluter Functions Special Functions Workload recording Multiple Aperture Zap Prime Reagents Run Samples Diagnostics Control Run Operator options Compressor On/Off Start Up Data Base Query...
Page 15 GETTING TO KNOW YOUR INSTRUMENT STATUS LINE TABLE STATUS LINE TABLE 07/13/99 19:34 ↑ ↓ Symbol Refers to Yellow White Data Connected to Not connected DMS busy or DMS is OK. Management Analyzer. to Analyzer. communicating receiving data. System with Analyzer. Graphics Autoprint is set Autoprint is set...
Page 16 GETTING TO KNOW YOUR INSTRUMENT DATA MANAGEMENT SYSTEM (DMS) DATA MANAGEMENT SYSTEM (DMS) Functions of the Data Management System (DMS) Controls and monitors instrument operation Displays, stores, outputs, and allows recall of sample results Stores and graphs control results for the QC program Automatically calculates new calibration factors Allows bidirectional communication with a host computer Consists of three major components: the computer, the monitor, and the printer...
Page 17 GETTING TO KNOW YOUR INSTRUMENT DATA MANAGEMENT SYSTEM (DMS) Layout Alphanumeric keys Configured in a standard typewriter keyboard layout Consists of all standard alphanumeric keys plus a handful of special computer keys and symbols Ú Works like the Shift Lock key on a typewriter With Caps Lock - Pressing any alphabet key on the keyboard produces an uppercase letter...
Page 18 GETTING TO KNOW YOUR INSTRUMENT DATA MANAGEMENT SYSTEM (DMS) Û Mainly used to confirm a menu or submenu selection which then activates a change in the screen display Do not use Û to bring up the DMS display as pressing this key may activate a command Keyboard has two Û...
Page 19 GETTING TO KNOW YOUR INSTRUMENT DATA MANAGEMENT SYSTEM (DMS) Screen Conventions DMS uses several conventions that either reduce keystrokes or aid the operator in obtaining the proper screen needed to complete a desired task Menu Item Conventions Are displayed in blue text Each menu item contains one black letter Pressing the corresponding alphabetic key is one way of selecting that particular menu item...
Page 20 GETTING TO KNOW YOUR INSTRUMENT MAIN UNIT - HmX Hematology Analyzer MAIN UNIT - HmX Hematology Analyzer Front View of the Main Unit POWER On/Off ECKMAN OULTER rocker switch READY indicator POWER light COMPUTER AC AC INPUT STANDBY indicator light Red LED Aspirator probe Green LED...
Page 21 GETTING TO KNOW YOUR INSTRUMENT MAIN UNIT - HmX Hematology Analyzer Instrument state is determined by the position of this rocker switch In the Ready state, the back portion of the rocker switch is flush with the instrument’ s base; this is position In the Standby state, the front portion of the rocker switch is flush with the instrument’...
Page 22 10 to 16 mm / length of 47 to 77 mm / capacity of 2 to 7 mL Beckman Coulter control and calibration tubes can also be used Before inserting a specimen tube through the entry port, it may be necessary to...
Page 23 GETTING TO KNOW YOUR INSTRUMENT MAIN UNIT - HmX Hematology Analyzer Secondary Mode Also referred to as the Open-Vial or Manual mode Aspirates 125 µL of sample from each tube via the aspirator probe Opening for aspiration is located on the back side of the aspirator probe’ s tip Mode used for processing Microsamples Retics...
Page 24 GETTING TO KNOW YOUR INSTRUMENT MAIN UNIT - HmX Hematology Analyzer MAIN UNIT - HmX Hematology Analyzer Modules on the Front of the Main Unit CBC module Analyzer module Electronic Power Supply BSV module Rotary Cap-Pierce module Pump module 1-14 PN 4237530BB...
Page 25 GETTING TO KNOW YOUR INSTRUMENT MAIN UNIT - HmX Hematology Analyzer INSTRUMENT MODULES Modules on the Front of the Main Unit Analyzer Module Also referred to as the Analyzer / Systems Control module Contains the various circuit boards needed to operate the instrument Controls the timing and sequencing of the operating cycles Receives pulses and raw data from the CBC and VCS modules Counts, measures, and computes CBC parameter results...
Page 26 GETTING TO KNOW YOUR INSTRUMENT MAIN UNIT - HmX Hematology Analyzer Right Side of the Main Unit 041993 Main Diluter module Mixing module LASER Flow Cell module Modules on the Right Side of the Main Unit Main Diluter Module Contains various components relating to sample dilution and cycling as well as vacuum and pressure regulators Flow Cell Module Contains the components necessary for analyzing the WBC Diff and Retics using VCS...
Page 27 GETTING TO KNOW YOUR INSTRUMENT MAIN UNIT - HmX Hematology Analyzer Back View of the Main Unit Fans Power ON/OFF rocker switch Reagent manifold connectors Plugs for computer Pneumatic Power Supply Module on the Back of the Main Unit Pneumatic Power Supply Source of the vacuums and pressures used throughout the instrument The compressor / vacuum pump produces one service adjustable level of air pressure, 60 psi and one nonadjustable level of vacuum, >22"...
Page 28 GETTING TO KNOW YOUR INSTRUMENT MAIN UNIT - HmX Hematology Analyzer with Autoloader MAIN UNIT - HmX Hematology Analyzer with Autoloader Front View of the Main Unit POWER On/Off rocker switch ECKMAN OULTER POWER READY COMPUTER AC AC INPUT indicator light STANDBY indicator...
Page 29 GETTING TO KNOW YOUR INSTRUMENT MAIN UNIT - HmX Hematology Analyzer with Autoloader Standby / Reset Rocker Switch Located on the left side of the lower front door, near the bottom Used to place instrument in a Ready or Standby state Symbol for indicating the Ready state is “...
Page 30 10 to 16 mm / length of 47 to 77 mm / capacity of 2 to 7 mL Beckman Coulter control and calibration tubes can also be used See Appendix A of the Reference Manual for a listing of tested collection devices Proper size cassette must be used Use only 10 to 13 mm o.d.
Page 31 GETTING TO KNOW YOUR INSTRUMENT MAIN UNIT - HmX Hematology Analyzer with Autoloader Predilute Mode Aspirator probe also used for running samples in the Predilute mode CBC mode only Requires specimen to be diluted 1:3 (minimum 50 µL of blood and 100 µL of diluent) Aspirates 125 µL of the prediluted sample via the aspirator probe Final results are calculated automatically Retic Mode...
Page 32 GETTING TO KNOW YOUR INSTRUMENT MAIN UNIT - HmX Hematology Analyzer with Autoloader MAIN UNIT - HmX Hematology Analyzer with Autoloader Modules on the Front of the Main Unit CBC module Analyzer module Electronic Power Supply BSV module Autoloader module Pump module 1-22 PN 4237530BB...
Page 33 GETTING TO KNOW YOUR INSTRUMENT MAIN UNIT - HmX Hematology Analyzer with Autoloader INSTRUMENT MODULES Modules on the Front of the Main Unit Analyzer Module Also referred to as the Analyzer / Systems Control module Contains the various circuit boards needed to operate the instrument Controls the timing and sequencing of the operating cycles Receives pulses and raw data from both the CBC and VCS modules Counts, measures, and computes CBC parameter results...
Page 34 GETTING TO KNOW YOUR INSTRUMENT MAIN UNIT - HmX Hematology Analyzer with Autoloader Right Side of the Main Unit 041993 Main Diluter module Mixing module LASER Flow Cell module Modules on the Right Side of the Main Unit Main Diluter Module Contains various components relating to sample dilution and cycling as well as vacuum and pressure regulators Flow Cell Module...
Page 35 GETTING TO KNOW YOUR INSTRUMENT MAIN UNIT - HmX Hematology Analyzer with Autoloader Back View of the Main Unit Fans Power ON/OFF rocker switch Reagent manifold connectors Plugs for computer Pneumatic Power Supply Module on the Back of the Main Unit Pneumatic Power Supply Source of the vacuums and pressures used throughout the instrument The compressor / vacuum pump produces one service adjustable level of air pressure,...
Page 36 GETTING TO KNOW YOUR INSTRUMENT REAGENTS REAGENTS Reagents Connected to the Main Unit Open Container Reagent Recommended Function DIFF Retic Stability Diluent ISOTON III diluent r Isotonic solution that Same as shelf life dilutes the sample (date printed on the container) r Stabilizes cell membranes r Conducts aperture...
Page 37 GETTING TO KNOW YOUR INSTRUMENT REAGENTS Special Reagents Used in Sample Preparation for Retic Analysis Open Container Reagent Recommended Function DIFF Retic Stability ReticPrep New Methylene Blue dye, r Stains any reticulum 60 Days Reagent A special formulation present in the RBCs ReticPrep Clearing reagent r Removes hemoglobin...
Page 38 GETTING TO KNOW YOUR INSTRUMENT REAGENTS 2 Replace the Reagent Container Turn the compressor off From the Main Menu, select Special Functions Diagnostics Operator Options then press Û; press the ßto select Fluidics Tests Compressor On/Off press Û again Open the new reagent container Remove the pickup tube assembly from the old container then transfer it directly to the new container and tighten Note: If the lower part of the assembly touches you or anything outside the container,...
Page 39: Startup / Shutdown
STARTUP / SHUTDOWN OBJECTIVES When the subject is complete, you will be able to . . . Startup Initiate a Startup. Recognize an out-of-limit result on the Startup Summary or System Status Values screen. Explain what to do if a Startup result is out of limits. Clean Cycle Initiate a Clean Cycle.
Page 40 STARTUP / SHUTDOWN OBJECTIVES NOTES PN 4237530BB...
Page 41 STARTUP / SHUTDOWN STARTUP STARTUP Must be completed before running patient specimens or controls anytime cleaning agent has replaced diluent in the aperture baths During a Clean Cycle, Startup is automatically initiated 30 minutes after completion of the Shutdown cycle Perform quality control checks before running patient specimens STARTUP SCREENS Summary Screen...
Page 42 STARTUP / SHUTDOWN STARTUP System Status Values Screen Also called the Second Start Up screen Allows an operator to review the detailed system check results Can only be viewed by pressing Ê when the Summary screen is displayed Background Values If any Background result is outside of its limits, Result is displayed in red Press Ë...
Page 43 STARTUP / SHUTDOWN STARTUP ➤ STARTUP SUMMARY 1 Check Current Instrument Status If the power is off, turn it on If the Main unit is in Standby, switch it to Ready If the DMS monitor is dark, press ß If Startup results are already displayed as the result of a Clean Cycle, go to step 3; if not, enter your three character Operator ID (optional) From the Main Menu, press Í...
Page 44 STARTUP / SHUTDOWN STARTUP NOTES PN 4237530BB...
Page 45 STARTUP / SHUTDOWN SHUTDOWN SHUTDOWN Allowing cleaning agent to remain in the instrument a minimum of 30 minutes minimizes protein buildup in the instrument Perform either a Clean Cycle or a Shutdown once every 24 hours that the instrument is in use Clean Cycle Consists of a Shutdown cycle followed 30 minutes later by a Startup cycle...
Page 46 STARTUP / SHUTDOWN SHUTDOWN ➤ SHUTDOWN SUMMARY 1 Perform Shut Down Verify SELECT FUNCTION is displayed on the status line From the Main Menu, select Diluter Functions Shut Down Press Û 2 Let the Instrument Stand Allow cleaning agent to remain in the instrument a minimum of 30 minutes Leave instrument power on Note: If the power is turned off and the instrument is going to be idle for more than 48 hours, do the Prolonged Shutdown Procedure in the Operator’...
Page 47: Set Up Options
SET UP OPTIONS OBJECTIVES When the subject is complete, you will be able to . . . Set up control files using the Control set up option. Enter data under the option to include flagging limits, display Sample analysis set up formats, and print options.
Page 48 SET UP OPTIONS OBJECTIVES NOTES PN 4237530BB...
Page 49 SET UP OPTIONS SET UP MENU OPTIONS SET UP MENU OPTIONS From the Main Menu, select to access this menu Special Functions Set Up submenu consists of three options Set Up Control set up Sample analysis set up System set up All the options available in the Set Up area of the DMS software are listed here Each menu item is listed with a short description For details, see Chapter 6 of the Operator’...
Page 50 SET UP OPTIONS CONTROL SET UP ➤ INITIAL SET UP OF CONTROL FILES SUMMARY Any Control File can be set up as a: LATRON control file (Latex file) 5C cell control file (CBC/DIFF file) Retic-C cell control file (RETIC file) Setting Up a LATRON Control File Select the File From the Main Menu, select...
Page 51 SET UP OPTIONS CONTROL SET UP Set Up Another Level of Control, if applicable file then press Û Move the cursor to a NOT SETUP Repeat steps 2 through 6 Remove the Diskette from Drive A: (after all needed set ups are complete) Setting Up a RETIC File Select the File From the Main Menu, select...
Page 52 SET UP OPTIONS SAMPLE ANALYSIS SET UP SAMPLE ANALYSIS SET UP From the Main Menu, select Special Functions Set Up Sample analysis set up For additional details, see Chapter 6 of the Operator’ s Guide Action limits XB limits Sets Target Values and Limits, user defined Definitive flag limits These word messages are generated based on user defined limits High/low flag limits...
Page 53 SET UP OPTIONS SAMPLE ANALYSIS SET UP Parameter Selection Enables or disables the Pct, PDW, and RET# Enables or disables the MRV and IRF Reporting Units Note: MRV and IRF parameters appear on this screen when these parameters are enabled. Selects the appropriate reporting units for the laboratory Delete database Deletes all samples in the data base and resets the system...
Page 54 SET UP OPTIONS SYSTEM SET UP SYSTEM SET UP From the Main Menu, select Special Functions Set Up System set up For additional details, see Chapter 6 of the Operator’ s Guide Shift Used to separate the control files into different shifts Reagents Updates the reagent log Institution...
Page 55: Quality Control
QUALITY CONTROL OBJECTIVES When the subject is complete, you will be able to . . . LATRON Primer and Control Explain the storage and handling requirements. State the open-vial stability. Prepare and run LATRON primer and control. Recognize an out-of-limits result on the LATRON screen. Using the Operator’...
Page 56 QUALITY CONTROL OBJECTIVES Control File Management Review numeric and graphic control data for errors and make appropriate corrections. Print and/or download control file data. Delete individual control runs. Delete a control file. Properly set up control files for running LATRON, 5C Cell Control, and/or Retic-C Cell Control.
Page 57 QUALITY CONTROL LATRON PRIMER AND CONTROL LATRON PRIMER AND CONTROL Daily quality control check to verify performance of the VCS technology TTM components in both the DIFF and Retic modes Must be at room temperature prior to use May be stored in the refrigerator but not necessary If stored in the refrigerator product must be brought to room temperature before running Instrument aspirates approximately 1.5 mL...
Page 58 QUALITY CONTROL LATRON PRIMER AND CONTROL Reviewing LATRON Control Results On the Control Run Screen Mean Channel result for Volume, Conductivity, and Scatter is displayed when a result is outside the limits (flag does not appear in red as its does on the Startup screen) CV results for Volume, Conductivity, and Scatter is displayed when a result is above the upper limit Using Î...
Page 59 QUALITY CONTROL LATRON PRIMER AND CONTROL ➤ Running LATRON Primer and Control Summary 1 Status for Proceeding Ensure Startup is complete LATRON Primer and Control must be at room temperature 2 Run LATRON Primer At the DMS From the Main Menu, select Controls Control Run If the LATRON file does not appear, press Ê...
Page 60 QUALITY CONTROL LATRON PRIMER AND CONTROL At the Diluter Gently invert the LATRON Control bottle 5 to 8 times Cycle LATRON Control in the Secondary mode Immerse the aspirator tip completely in the control Do not place the tip against the side of the bottle Press and release the sample bar Listen for the beep or verify the status line message changes from Aspirating to Diluting before removing the bottle...
Page 61 QUALITY CONTROL 5C CELL CONTROL 5C CELL CONTROL Material for quality control of CBC and DIFF parameters 5C Cell Control is assayed only for Primary mode Three levels of control with varying mixtures of normal and abnormal values: Normal, Abnormal I, and Abnormal II Storage Control must be stored at 2 to 8°C (35 to 46°F) Storage of the control product in the cap down (inverted) position is not recommended...
Page 62 QUALITY CONTROL 5C CELL CONTROL Indications of Instability A slight pink color to the supernatant is normal Inability to obtain expected values in the absence of known instrument problems or gross hemolysis (darkly colored supernatant) indicates deterioration of the control Running 5C Cell Control Control Run Option Using the...
Page 63 QUALITY CONTROL 5C CELL CONTROL ➤ Running 5C Cell Control Summary 1 Getting the DMS Ready If SELECT FUNCTION is displayed If SELECT FUNCTION is not displayed From the Main Menu, select From the Main Menu, select Sample Sample Analysis Run Samples Analysis Run Samples...
Page 64 QUALITY CONTROL 5C CELL CONTROL 4 Review Results If using a HmX Hematology Analyzer with Autoloader To verify control results are stored in the control file, select Controls Review or Report If the bar code was not facing up properly or if the bar code was not read because it is damaged, control results are stored in the patient data base If the bar code was not facing up, position it correctly and run the control again If the bar code is damaged, see the...
Page 65 QUALITY CONTROL RETIC-C CELL CONTROL RETIC-C CELL CONTROL Three levels: Level I, Level II and Level III Controls can only be analyzed after sample preparation is completed using the COULTER ReticPrep Reagent Kit Used for monitoring the Coulter method of reticulocyte analysis which uses VCS technology Cannot be used to control the manual method Storage...
Page 66 QUALITY CONTROL RETIC-C CELL CONTROL Running Retic-C Cell Control Use the option for processing Control Run Prepare a dilution using the COULTER ReticPrep Reagent Kit before analysis Run in the Secondary mode Special Reagents Needed for Retic Analysis Open Container Reagent Recommended Function...
Page 67 QUALITY CONTROL RETIC-C CELL CONTROL ➤ Running Retic-C Cell Control Summary 1 Prepare Controls according to the Package Insert Warm controls at room temperature 10 to 15 minutes Mix each control tube using the 8 x 8 x 8 method once Do not use a mechanical mixer 2 Preparing the Control For each control tested, label two 12 x 75 mm test tubes "A"...
Page 68 QUALITY CONTROL REVIEWING CONTROL RESULTS REVIEWING CONTROL RESULTS Using Control Menu Options to Review 5C Cell Control or Retic-C Results Note: MRV and IRF parameters appear on the retic screens when these parameters are enabled. On the Control Run Screen Compares control results to expected ranges is displayed when a result is outside the limits (flag does not appear in red as it does on the Startup screen)
Page 69 QUALITY CONTROL TABLE OF QUALITY CONTROL MATERIALS TABLE OF QUALITY CONTROL MATERIALS Recommended Open Vial QC material Function DIFF Retic Stability LATRON Primer Cleans and prepares the pathway for 30 Days running LATRON Control LATRON Control Checks the functioning of the VCS 30 Days Technology 5C Cell Control...
Page 70 QUALITY CONTROL CONTROL FILE MANAGEMENT CONTROL FILE MANAGEMENT Once a control file is initially set up, the file: Never reverts back to a status NOT SET UP Is considered an existing control file Two types of existing control files Control file that contains control run data (may be either current or old data) Control file with no stored control run data because the file is either newly set up or has had all its control runs deleted from it Existing Control Files Currently In Use...
Page 71 QUALITY CONTROL CONTROL FILE MANAGEMENT ➤ MAKING CHANGES TO A CONTROL FILE CURRENTLY IN USE Use only if you want to make a change in a control file that is currently in use. This summary should be used when changing individual items in a previously set up control file, such as entering a running mean or correcting a typographical error.
Page 72 Note: Management of these control files differs depending on whether the laboratory wants to use the default limits / expected ranges (from the Table of Expected Results on the Beckman Coulter package insert) or the laboratory wants to use their own custom ranges (expected ranges established by the laboratory).
Page 73 QUALITY CONTROL CONTROL FILE MANAGEMENT Management of Existing Control Files No Longer In Use . . . a Comparison Using Default Limits / Expected Range Using Custom Ranges (from the package insert) (established by your laboratory) 1. Control file is initially set up using a 1.
Page 74 QUALITY CONTROL CONTROL FILE MANAGEMENT ➤ CONTROL FILE MANAGEMENT SUMMARY (Using the Default Limits/Expected Range from the Package Insert) Note: To maintain customized expected ranges in a control file, use the Control File Management Using Your Laboratory’s Custom Ranges Summary Review the Numeric Control Data and Graphs, if applicable Locate the Control File From the Main Menu, select...
Page 75 QUALITY CONTROL CONTROL FILE MANAGEMENT Setting Up a 5C Cell Control File Select the File From the Main Menu, select Special Functions Set Up Control set up CBC/DIFF file Move the cursor to a NOT SETUP file or an inactive file where the control run data is deleted then press Û...
Page 76 QUALITY CONTROL CONTROL FILE MANAGEMENT Setting Up a RETIC File Select the File From the Main Menu, select Special Functions Set Up Control set up RETIC file Move the cursor to a NOT SETUP file or an inactive file where the control run data is deleted then press Û...
Page 77 QUALITY CONTROL CONTROL FILE MANAGEMENT ➤ CONTROL FILE MANAGEMENT SUMMARY (Using Your Laboratory’s Custom Ranges) Use this summary only if you want to maintain the customized expected ranges previously entered in an existing control file (typically a 5C control file). Review the Numeric Control Data and Graphs, if applicable Locate the Control File From the Main Menu, select...
Page 78 QUALITY CONTROL CONTROL FILE MANAGEMENT Upload the 5C Control Assay Values Insert the 5C cell control diskette into the A: drive of the computer Press Í Upload Assay Values Press the function key for the desired level of control Type Manual Entries Select the Shift and manually type the Operator ID Verify All Information Make sure the Host transmit setting correlates with your laboratory’...
Page 79 QUALITY CONTROL ADDITIONAL QC CHECKS ADDITIONAL QC CHECKS Mode-to-Mode Comparison Ensures both the Primary and Secondary aspiration modes recover similar values Minor differences between the Primary and Secondary modes are due to differences in the flow characteristics of the aspiration pathways 5C cell control is assayed for Primary mode only Recommended procedure is located in Chapter 2 of the Operator’...
Page 80 QUALITY CONTROL ADDITIONAL QC CHECKS Analysis X = Mean B = Bull (for Brian S. Bull, M.D.) Pronounced x-bar-bee Appears on the DMS screen as XB XB will default to ON if instrument is reset Analysis, a Quality Control Tool Analysis is a quality control method that allows a laboratory to continuously monitor the performance of their automated hematology system and thus control the quality of their results...
Page 81 QUALITY CONTROL ADDITIONAL QC CHECKS As long as the patient population remains constant, the target values of each index also remain constant If the patient population changes, the mean of an index may also change and needs to be reevaluated Dr.
Page 82 QUALITY CONTROL ADDITIONAL QC CHECKS Having the other RBC parameters displayed allows the operator to judge the validity of the sample results when an out-of-limits situation occurs When the batch of 20 patient samples is completed, the DMS performs the X Analysis and determines the batch mean of each index (MCV, MCH, and MCHC) Method for obtaining the batch mean is rather complicated, but the calculation is...
Page 83 QUALITY CONTROL ADDITIONAL QC CHECKS XB Batch Means Option Used to view the calculated batch means for the last batch of 20 samples collected Also provides the percent difference between the calculated batch mean and its corresponding target value If a percent difference is outside the action limit, the parameter is flagged with an May be used to identify the affected RBC indices and to determine the direction and amount of the change After the first 20 batches are completed, this option always displays the last 20...
Page 84 QUALITY CONTROL ADDITIONAL QC CHECKS Troubleshooting when an XB Batch is “Out” Consider a Change in the Patient Population Is there a change in the overall patient population? One or more new patient types were added to the population One or more patient types are no longer part of the population Possible seasonal change of the patient population (hospitals or clinics in resort areas) If a change in the overall patient population is probable,...
Page 85 QUALITY CONTROL ADDITIONAL QC CHECKS Assessing the Situation Review the XB Graphs and XB Batch Means options to identify the out-of-limits RBC indices and note the direction of the change (increased or decreased) Generally two of the three RBC indices are affected It is also important to note any index that may still be inside the limit but shows a significant change Identifying the Parameter Causing the Problem...
Page 86 QUALITY CONTROL ADDITIONAL QC CHECKS NOTES 4-32 PN 4237530BB...
Page 87: Calibration
CALIBRATION OBJECTIVES When the subject is complete, you will be able to . . . Explain the purpose of calibration. Tell when one needs to verify calibration. Perform the preliminary procedures. Perform the calibration procedure using the Special Procedures and Troubleshooting (SPT) Manual.
Page 88 CALIBRATION OBJECTIVES NOTES PN 4237530BB...
Page 89 After you replace any component dealing with Dilution preparation, such as the BSV Primary measurement, such as an aperture If your Beckman Coulter Representative suggests you calibrate When to Verify Calibration As dictated by your laboratory procedures, local, or national regulations When controls show evidence of unusual trends When controls exceed the manufacturer’...
Page 90 Do a Start Up Run commercial cell controls CALIBRATION PROCEDURE Beckman Coulter recommends using S-CAL Calibrator and performing the procedure in the Primary mode (Closed-Vial mode) Carefully follow the instructions in Chapter 1 of the Special Procedures and Troubleshooting (SPT) Manual anytime calibration is performed...
Page 91 CALIBRATION CALIBRATION PROCEDURE Terms and Formulas used in the CBC Calibration Procedure MEAN Average of the 10 S-CAL calibrator runs Run 1 of the 11 runs is automatically deleted NEW CAL FACTOR Calibration Factor needed to recover the S-CAL Calibrator Reference value It is calculated and displayed regardless of whether or not you need to change it ×...
Page 92 CALIBRATION CALIBRATION PROCEDURE PN 4237530BB...
Page 93: Sample Analysis
SAMPLE ANALYSIS OBJECTIVES When the subject is complete, you will be able to . . . Basics of Running a Sample State the proper anticoagulant to use for specimens processed on a HmX Hematology Analyzer with Autoloader or HmX Hematology Analyzer. State the minimum volume of blood needed for the Primary mode, Secondary mode, Predilute mode, and Retic mode.
Page 94 SAMPLE ANALYSIS OBJECTIVES Run Samples Screen Explain É through Í and Ñ on the Run Samples screen. Name and define each area on the Run Samples screen. Label the WBC populations on a normal DF1 scatterplot. Use Ó to display Suspect and Definitive flag messages. Retic Mode State the volumes used in the reticulocyte procedure for: Whole blood...
Page 95 SAMPLE ANALYSIS SAMPLE HANDLING SAMPLE HANDLING Specimen Collection Using Evacuated Collection Tubes Collect venous blood specimens in K EDTA or K EDTA A proper proportion of whole blood to anticoagulant is critical EDTA is the preferred anticoagulant because all performance claims and validation studies are based on its use EDTA shows no significant differences for CBC and differential results generated by instruments using VCS technology...
Page 96 SAMPLE ANALYSIS BAR-CODE LABELING Correct Incorrect Stopper Bars not Bars parallel parallel to stopper to stopper Incorrect Label covers the bottom end of the tube Proper Placement of a Bar-Code Label on a Specimen Tube Bar-code labels must be within specifications as stated in the Reference Manual The bars on the label must be parallel to the stopper If the label is skewed more than 5 degrees, the scanner may not read it Do not cover the bottom of the tube with the bar-code label...
Page 97 SAMPLE ANALYSIS CYCLING OPTIONS CYCLING OPTIONS F3-Run Options From the Main Menu, select Sample Analysis Run Samples tt F3-Run Ê START PRIMARY Closed-Vial mode Ë SECONDARY Open-Vial mode Ì PREDILUTE CBC Open-Vial mode only For processing a 1:3 sample dilution (1 part blood to 2 parts diluent) in the Secondary mode Í...
Page 98 SAMPLE ANALYSIS CYCLING OPTIONS F5-Optns From the Main Menu, select Sample Analysis Run Samples F5-Optns Ê XB Three indicators: ON / OFF current usage of X Analysis number of patient samples accumulated in the current batch IN / OUT status of the last completed batch of 20 patient samples Display Only is ON, then XB is automatically turned OFF If instrument is reset, ON is the default setting...
Page 99 SAMPLE ANALYSIS CYCLING OPTIONS Ï Display Only Useful for cycling samples when an operator does not want results sent to the host computer or stored in XB or the data base Especially helpful when troubleshooting Quick way to turn XB, DB, and Host off then back on simultaneously Position of the arrows on the Status line easily verifies the current state of these options If instrument is reset, OFF is the default setting...
Page 100 SAMPLE ANALYSIS CYCLING OPTIONS NOTES PN 4237530BB...
Page 101 SAMPLE ANALYSIS RUNNING WHOLE BLOOD PATIENT SAMPLES (Using a HmX Hematology Analyzer) RUNNING WHOLE BLOOD PATIENT SAMPLES (Using a HmX Hematology Analyzer) Running Patient Samples in the Primary Mode Lower door must remain closed during operation Aspirator probe is retracted Scanning the Bar-Code Label on the Specimen Tube Uses a laser bar-code scanner Reading the bar-code label provides positive identification of the patient sample...
Page 102 SAMPLE ANALYSIS RUNNING WHOLE BLOOD PATIENT SAMPLES (Using a HmX Hematology Analyzer) Steps for Changing the Carousel Slot Note: Since the majority of specimen tubes are 10 to 13 mm tubes, the carousel is most likely using the 10mm-13mm slot. Before beginning this sequence, note the appearance of this solid black 10mm-13mm slot.
Page 103 SAMPLE ANALYSIS RUNNING WHOLE BLOOD PATIENT SAMPLES (Using a HmX Hematology Analyzer) ➤ Running Whole Blood Patient Samples in the Primary Mode Summary (Using a HmX Hematology Analyzer) Getting the DMS Ready If not using the Worklist If SELECT FUNCTION is displayed, If SELECT FUNCTION is not displayed, From the Main Menu, select From the Main Menu, select...
Page 104 SAMPLE ANALYSIS RUNNING WHOLE BLOOD PATIENT SAMPLES (Using a HmX Hematology Analyzer) Process the Sample With Bar-Code Labels Mix the specimen gently but thoroughly Hold the tube’ s bar-code label in front of the reader Listen for the beep and verify the green LED is glowing Confirm the ID appears in the Enter ID field Properly insert the specimen tube into the carousel Without Bar-Code Labels...
Page 105 SAMPLE ANALYSIS RUNNING WHOLE BLOOD PATIENT SAMPLES (Using a HmX Hematology Analyzer) ➤ Running Whole Blood Patient Samples in the Secondary Mode Summary (Using a HmX Hematology Analyzer) Getting the DMS Ready If not using the Worklist If using the Worklist From the Main Menu, select Sample From the Main Menu, select...
Page 106 SAMPLE ANALYSIS RUNNING WHOLE BLOOD PATIENT SAMPLES (Using a HmX Hematology Analyzer) NOTES 6-14 PN 4237530BB...
Page 107 SAMPLE ANALYSIS RUNNING WHOLE BLOOD PATIENT SAMPLES (Using a HmX Hematology Analyzer with Autoloader) RUNNING WHOLE BLOOD PATIENT SAMPLES (Using a HmX Hematology Analyzer with Autoloader) Running Patient Samples in the Primary Mode Lower door must remain closed during operation Aspirator probe is retracted Up to five specimen tubes can be loaded into a cassette, barcode labels up Up to five cassettes can be stacked in the loading bay...
Page 108 SAMPLE ANALYSIS RUNNING WHOLE BLOOD PATIENT SAMPLES (Using a HmX Hematology Analyzer with Autoloader) NOTES 6-16 PN 4237530BB...
Page 109 SAMPLE ANALYSIS RUNNING WHOLE BLOOD PATIENT SAMPLES (Using a HmX Hematology Analyzer with Autoloader) ➤ Running Whole Blood Patient Samples Summary (Using a HmX Hematology Analyzer with Autoloader) Running Whole Blood Samples in the Primary Mode Getting the DMS Ready If not using the Worklist If SELECT FUNCTION is displayed, If SELECT FUNCTION is not displayed,...
Page 110 SAMPLE ANALYSIS RUNNING WHOLE BLOOD PATIENT SAMPLES (Using a HmX Hematology Analyzer with Autoloader) When the Run is Complete Verify all sample ID entries before reporting results Remove cassettes from the unloading bay If using the Worklist, periodically check for accumulation of Status messages Interrupting Primary Mode Operation to Run a STAT Press Ë...
Page 111 SAMPLE ANALYSIS PREDILUTE MODE PREDILUTE MODE Diluted samples are aspirated through the Secondary mode Dilution ratio must be 1 part blood to 2 parts diluent Minimum sample to be used is 50 µL of whole blood to 100 µL of diluent Must make dilutions from properly collected specimen tubes System generates CBC results only WBCs are not in their “near-native state”...
Page 112 SAMPLE ANALYSIS PREDILUTE MODE ➤ Running Patient Samples in the Predilute Mode Summary For HmX Hematology Analyzer with Autoloader and HmX Hematology Analyzer Getting the DMS Ready If not using the Worklist If using the Worklist From the Main Menu, select Sample From the Main Menu, select Sample...
Page 113 SAMPLE ANALYSIS RUN SAMPLES SCREEN RUN SAMPLES SCREEN Screen Display Monocyte Population Condition Messages Neutrophil Population HmX Hematology Analyzer with Autoloader only Cass/Pos number or Eosinophil Population S = Secondary PrD = Predilute RET = Retic RBC Histogram HmX Hematology Analyzer only Mode P = Primary S = Secondary...
Page 114 SAMPLE ANALYSIS RUN SAMPLES SCREEN Run Samples Screen Areas Demographics Area IMPORTANT Risk of misidentification. Do not use the tilde (~) character in demographics, including Specimen or Patient ID. ID # 1 Alpha and/or numeric characters read from a bar-code label If no barcode is read on a HmX Hematology Analyzer with Autoloader system, then dashes ( - - - - - - - - - - - ) are displayed Alpha and/or numeric characters can be manually typed to identify a specimen to be...
Page 115 SAMPLE ANALYSIS RUN SAMPLES SCREEN Basophils (available on DF3 view only) F6-DF option is used to look at the different scatterplot views Condition Messages Population condition messages appear in the lower left corner Normal WBC Pop Abnormal WBC Pop Normal RBC Pop Abnormal RBC Pop Normal Plt Pop Abnormal Plt Pop...
Page 116 SAMPLE ANALYSIS RUN SAMPLES SCREEN NOTES 6-24 PN 4237530BB...
Page 117 50 µL air displacement pipette for measuring the proper whole blood sample volume 2 µL air displacement pipette for measuring the proper volume of the incubated blood/stain mixture 2 mL dispenser (available from Beckman Coulter) for delivering the proper volume of Reagent B Volume Requirements 50 µL of whole blood...
Page 118 SAMPLE ANALYSIS RETIC MODE Reporting Retic Results Retic % is directly measured using VCS technology Retic # is computed based on the Retic % and the RBC count Retic # cannot be obtained at the time of the run Retic results may be printed alone or combined with CBC results MRV and IRF Parameters MRV (Mean Reticulocyte Volume) Average cell volume of the reticulocytes...
Page 119 SAMPLE ANALYSIS RETIC MODE ➤ Running Samples in the Retic Mode Summary For HmX Hematology Analyzer with Autoloader and HmX Hematology Analyzer Preparing the Sample For each patient tested, label two 12 x 75 mm test tubes with the patient’ s ID then label one tube "A"...
Page 120 SAMPLE ANALYSIS RETIC MODE NOTES 6-28 PN 4237530BB...
Page 121 SAMPLE ANALYSIS WORKLIST (Optional) WORKLIST (Optional) A Worklist is a list of work to be done Worklists are used to preassign identifiers and/or demographics Preassigning a Worklist is mainly done by laboratories that do not use bar-code labels → the Worklist offers an alternative that still allows positive identification of their patient samples (particularly if using a HmX Hematology Analyzer with Autoloader) Status Messages Status messages appear on the Worklist in the far right column, the Status column...
Page 122 SAMPLE ANALYSIS WORKLIST (Optional) PARTial ASPiration A sample processed in the Primary mode that fails the blood detection criteria is considered a partial aspiration When the system detects a partial aspiration, the ..Analyzer replaces all numeric results with the ( ) code and sends this information to the DMS DMS searches the Worklist for a match based on the primary identifier →...
Page 123 SAMPLE ANALYSIS WORKLIST (Optional) 3 Consecutive NO MATCH Messages If there are three consecutive NO MATCH error messages: The system stops A beeping alarm sounds An error message, 3 CONSECUTIVE NO MATCHES, appears at the bottom of the screen The background of the Status line indicator turns red Operator response is needed to resume operation Note: See the...
Page 124 SAMPLE ANALYSIS WORKLIST (Optional) 10 NO READ, NO MATCH, PART ASP If any combination of 10 PART ASP , NO MATCH and/or NO READ errors accumulate on the Worklist: The system stops A beeping alarm sounds An error message appears at the bottom of the screen The background of the Status line indicator turns red Operator response is needed to resume operation...
Page 125: Data Review
DATA REVIEW OBJECTIVES When the subject is complete, you will be able to . . . Data Base Query Define the functions of the option. Data Base Query Explain the areas of the Data Base Query screen. Define each function key of the Data Base Query screen. List the sort screen options.
Page 126 DATA REVIEW OBJECTIVES Explain the area of a typical Plt histogram used to determine the Plt count and MPV parameter result. Describe a typical Plt histogram. State the conditions that generate a “no-fit” platelet result. WBC Parameters List the individual parameters that comprise the WBC Profile. Identify which parameters in the WBC Profile are directly measured, derived from the scatterplot, or computed.
Page 127 DATA REVIEW DATA BASE QUERY DATA BASE QUERY Option allows an operator to sort, retrieve, review, print, transmit, archive to diskette and mark for saving previously stored sample results Archive feature allows an operator to copy patient result data from the DMS onto a diskette and retrieve it on another computer in a spreadsheet format Note: Spreadsheet program must be compatible with the WKS format.
Page 128 DATA REVIEW DATA BASE QUERY ➤ DATA BASE QUERY QUICK REFERENCE GUIDE If the SELECT FUNCTION prompt isn’t displayed, press Ñ STOP From the Main Menu, select Sample Analysis Data Base Query To Sort Sample Data Press Î Sort if the Sort window is not displayed Select the group of samples you want to review or work on To find samples run during a certain time period, enter the DATE and TIME in the appropriate FROM and TO fields (enter “00”...
Page 129 DATA REVIEW DATA BASE QUERY To Save Sample Data Execute a sort Use æ or ç to highlight the sample to be saved → an Press Ê Save appears in the Output field to indicate the sample is saved from overwriting Note: Use this same routine to unsave a sample.
Page 130 DATA REVIEW DATA BASE QUERY When an operator edits any parameter field, an Edited Data message appears in the Population Condition field on the following: Sample analysis display Sample analysis data base displays With RBC and Retic # if transmitted to a host computer Printouts When an operator edits any parameter, all Suspect and Definitive messages for that sample are deleted from the data base and all displays...
Page 131 DATA REVIEW DATA BASE QUERY To Archive a Group of Stored Sample Results Execute a sort Tag the desired samples using Ï or Ð Tag All Press Í Batch Move the cursor to the Archive field then press Ê Choice List Use the ß...
Page 132 DATA REVIEW DATA BASE QUERY NOTES PN 4237530BB...
Page 133 DATA REVIEW BASICS OF CBC ANALYSIS BASICS OF CBC ANALYSIS Sample Dilutions During aspiration, whole blood is pulled through the BSV Once aspiration is complete, the center section of the BSV rotates to segment the whole blood sample into three portions Whole blood contained in the center section’...
Page 134 DATA REVIEW BASICS OF CBC ANALYSIS The Coulter Principle Vacuum Aperture Internal current electrode External electrode Detail of Blood cell aperture Sample suspension beaker Aperture Aperture tube The Coulter Principle is an electronic method for counting and sizing particles; it is based on the fact that cells, which are poor conductors of a weak current, will interrupt the current flow The cells are suspended in a conductive diluent and are pulled through the aperture by a...
Page 135 DATA REVIEW BASICS OF CBC ANALYSIS Coincidence Correction Normal particle passage Coincidence passage Occasionally, more than one cell goes through the aperture at the same time and the analyzer counts only one pulse Phenomenon is referred to as coincidence Since the frequency of coincidence is statistically predictable for a particular count, the system computer makes the correction Count Periods Raw data for determining the WBC and RBC counts is collected over three consecutive...
Page 136 DATA REVIEW BASICS OF CBC ANALYSIS Thresholds Thresholds are electronically set size limits Particles, such as debris, are excluded from the analysis Particles equal to or above the threshold are analyzed WBC lower threshold is 35 fL; no upper threshold for counting RBC lower threshold is 36 fL;...
Page 137 DATA REVIEW BASICS OF CBC ANALYSIS Parameters Derived from a Histogram HmX instruments use the Coulter Principle and extended sensing to develop RBC and Plt histograms Three individual histograms are developed MCV and RDW parameter results are derived from each RBC histogram Plt and MPV parameter results are derived from each Plt histogram The three results generated for each parameter go through the voting process Voting...
Page 138 DATA REVIEW BASICS OF CBC ANALYSIS NOTES 7-14 PN 4237530BB...
Page 139 DATA REVIEW RBC PARAMETERS RBC PARAMETERS RBC Count RBC count is obtained from the RBC dilution RBC dilution contains red blood cells, white blood cells, and platelets Thresholds are used to separate the platelet pulses, which are smaller, from the red and white blood cell pulses Particles 36 fL or larger are counted as red blood cells Since white blood cells fall in the red blood cell size range, they are counted and...
Page 140 DATA REVIEW RBC PARAMETERS Characteristics of a Typical RBC Histogram Typical RBC histograms have two populations of cells: The main population of red cells begins above 50 fL and is visually a symmetrical, bell-shaped curve (a narrow Gaussian distribution) The smaller population (called the “toe”) appears to the right of the main population Represents white blood cells, doublets, triplets, agglutinates, and artifacts The white blood cells included in the RBC histogram are normally insignificant...
Page 141 DATA REVIEW RBC PARAMETERS Flagging the RDW Normal Distribution RDW is a percent measurement of the variability (CV) in the size of the red cells based on the main population Since the areas to the left and to the Normal right of the main population vary distribution (sometimes significantly due to...
Page 142 DATA REVIEW RBC PARAMETERS Hemoglobin Hgb value is determined from the WBC dilution The addition of CBC lytic reagent disrupts the red cells to free the hemoglobin which is then converted to a stable pigment Converted hemoglobin is directly measured using a photometric technique based on Beer’...
Page 143 DATA REVIEW PLATELET PARAMETERS PLATELET PARAMETERS Platelet parameters are obtained from the RBC dilution Sweep Flow Sweep flow is a steady stream of diluent that flows behind the RBC aperture during sensing periods Without sweep 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 144 DATA REVIEW PLATELET PARAMETERS Plt Histogram Platelet histograms reflect the native size of the platelets and any other particle in the platelet size range Platelet histograms provide the information for determining three different descriptors of the platelet population using 64 channels Platelet count MPV (Mean Platelet Volume) PDW (Platelet Distribution Width) results are not displayed but are used as an...
Page 145 DATA REVIEW PLATELET PARAMETERS Characteristics of a Typical Platelet Histogram Typical platelet histograms are log normal and have two curves: A smooth curve extending from 2 to 20 fL The term “smooth” does not refer to the “look” of the curve but rather to the use of the moving average technique to smooth out the peaks and valleys of the raw data The smooth curve represents the actual particles counted (raw data) during the...
Page 146 DATA REVIEW PLATELET PARAMETERS Criteria for Fit and No-Fit Platelet count > 20,000 Smooth curve PLT R MPV R Positive curve Smooth curve PLT R MPV R Mode 3 - 15 fL Smooth curve PLT R MPV R PDW < 20% Smooth curve PLT R MPV R...
Page 147 DATA REVIEW PLATELET PARAMETERS Criteria for Fit and No-Fit (continued) Criteria for PLT-Fit Criteria for PLT No-Fit > 20,000 Platelet count < 20,000 Platelet count Log normal curve Non-positive curve (Positive curve) Mode <3 fL or >15 fL Mode between 3 and 15 fL 15 fL 15 fL...
Page 148 DATA REVIEW PLATELET PARAMETERS Platelet Parameters Category Parameter Source of Data Derived from the Plt Histogram Plt Histogram (Platelet Count) (Developed using the Coulter Principle) Plt Histogram (Mean Platelet Volume) (Developed using the Coulter Principle) Plt Histogram (Platelet Distribution Width) (Developed using the Coulter Principle) Computed ×...
Page 149 DATA REVIEW WBC PARAMETERS WBC PARAMETERS WBC Count Total WBC count is obtained in the WBC bath after the addition of CBC lytic reagent All particles in the WBC dilution 35 fL or greater are counted as white blood cells Any interference detected at the 35 fL WBC threshold generates an flag next to the WBC count result, indicating failure of the lower WBC threshold check...
Page 150 DATA REVIEW WBC PARAMETERS WBC Parameters Category Parameter Source of Data Directly Measured Coulter Principle (White Blood Count) Derived from the WBC Scatterplot NE % VCS Measurements (Neutrophil Percentage) LY % VCS Measurements (Lymphocyte Percentage) MO % VCS Measurements (Monocyte Percentage) EO % VCS Measurements (Eosinophil Percentage)
Page 151 DATA REVIEW VCS TECHNOLOGY BASICS VCS TECHNOLOGY BASICS Applications of the VCS Technology Differential Analysis First application of the VCS technology was to develop a scatterplot from which a five part differential could be derived Neutrophil %, lymphocyte %, monocyte %, eosinophil %, and basophil % are derived from the WBC scatterplot Reticulocyte Analysis Early in 1994, Coulter Corporation adapted the VCS technology to perform reticulocyte...
Page 152 DATA REVIEW VCS TECHNOLOGY BASICS Differential Analysis Preparing the Sample Sample Erythrolyse II Sheath (diff lytic reagent) Vented tank waste Sample pressure Flow cell Stabilyse (diff leukocyte preservative) Sheath Erythrolyse II Mixing fluid (diff lytic reagent) chamber Blood StabiLyse (diff leukocyte preservative) Prepared sample...
Page 153 DATA REVIEW VCS TECHNOLOGY BASICS Analyzing the Sample Waste out Upper output Upper input Flow cell aperture Lower output Lower input Sample in Pressurized Pressurized sheath fluid sheath fluid Pressurized sample Sample pressure, applied to the Mixing Chamber, pushes the sample through the Flow Cell which is located inside the Triple Transducer Module (TTM) As the sample stream is pushed into the Flow Cell, the white blood cells are hydrodynamically focused through the aperture of the Flow Cell...
Page 154 DATA REVIEW VCS TECHNOLOGY BASICS VCS Measurements Coulter Principle Direct current Total Total cell cell volume volume Cell surface Nuclear volume characteristics nuclear/cytoplasm ratio High frequency Laser current Granularity Granularity Conductivity Principle Light Scatter Principle Volume “V” in VCS technology refers to the volume of the WBC in its near-native state Plotted on the Y-axis Uses the Coulter Principle Uses direct or low frequency current (DC)
Page 155 DATA REVIEW VCS TECHNOLOGY BASICS Conductivity “C” in VCS technology refers to the conductivity of the WBC in its near-native state Plotted on the Z-axis Uses high frequency current (RF) which can penetrate the cell to evaluate internal constituents such as: Nucleus Granularity Other physical components of the cell...
Page 156 DATA REVIEW VCS TECHNOLOGY BASICS Simultaneous Analysis Scatter Volume Conductivity VCS simultaneous measurement Each cell is analyzed by all three technologies at the same time Diff sample analysis continues until either 8192 cells are accumulated or a maximum of 30 seconds elapse 7-32 PN 4237530BB...
Page 157 DATA REVIEW VCS TECHNOLOGY BASICS VCS Cube Scatter (Laser light) Three measurements on each cell plotted in three dimensions Think of the XYZ coordinates as VCS coordinates Each axis is divided into 256 channels ( divisions / categories ) 256 channels for Volume 256 channels for Conductivity 256 channels of laser light Scatter 256 x 256 x 256 = approximately 16.7 million different VCS coordinates within the cube...
Page 158 DATA REVIEW VCS TECHNOLOGY BASICS Cubes Within the Cube The smaller cubes within the cube also have VCS coordinates For example, the call-out cube has a certain amount of Volume, a certain amount of Conductivity, and a certain amount of Scatter that match a certain type of cell . . . considering the call-out cube’...
Page 159 DATA REVIEW VCS TECHNOLOGY BASICS ³ Yellow 5-10 Green Blue Color Black and white 7-35 PN 4237530BB...
Page 160 DATA REVIEW VCS TECHNOLOGY BASICS Labeled Scatterplot Y-axis is always VOLUME X-axis can be SCATTER or CONDUCTIVITY (dependent upon which side of the cube is being viewed) There are no units on any axis Discriminator Lines Moveable, will vary from sample to sample Not used by the computer, more an operator benefit Locate the lowest horizontal discriminator line Above this line, cells are called WBCs and included in the differential...
Page 161 DATA REVIEW VCS TECHNOLOGY BASICS Cube View Basophils Neutrophils Monocytes DF 2 DF 3 DF 1 Lymphocytes Eosinophils Notice the lymphocytes and monocytes tend to have the same Scatter and Conductivity; the factor that separates them is Volume Notice granulocytes all tend to have the same Conductivity; the factor that separates them is their Scatter (mainly due to their different granules) Notice the lymphocytes and basophils tend to have the same Scatter and Volume;...
Page 162 DATA REVIEW VCS TECHNOLOGY BASICS eticulocyte Analysis Typical Normal Retic Pattern - DF5 View Same VCS technology but using a different reagent system Retic analysis continues until either 32,768 RBCs are accumulated or a maximum of 30 seconds elapse DF5 is the Retic version of DF1 (VOLUME vs. SCATTER) The younger the red cell, the higher the volume The younger the red cell, the higher the light scatter because there’...
Page 163 DATA REVIEW VCS TECHNOLOGY BASICS MRV and IRF Parameters MRV (Mean Reticulocyte Volume) Average cell volume of the reticulocytes Determined by the VCS technology algorithm from the retic scatterplot Reported in femtoliters (fL) IRF (Immature Reticulocyte Fraction) IRF parameter is based on the following factors: Degree of stained reticulum (using New Methylene Blue dye) is proportional to the degree of RNA present in the cell and, therefore, the amount of light scatter produced...
Page 164 DATA REVIEW FLAGGING FLAGGING Flagging Categories There are four categories of flags that may be generated while processing patient samples Condition Messages Suspect Messages Operator Definable Flags Definitive Messages High/Low Flags Parameter Codes Each is designed to alert the operator that an abnormality may be present When a flag appears, the operator should take action according to the review protocol established by their laboratory for that flag Condition Messages...
Page 165 DATA REVIEW FLAGGING Suspect Messages Word messages generated by the DMS Computer generates these messages according to a complex internal algorithm which cannot be changed by the operator Used to flag an abnormal cell distribution or population (possible abnormal morphology) Use Ó...
Page 166 DATA REVIEW FLAGGING Operator-Definable Flags There are two types of Operator-Definable flags Definitive messages Definitive word messages are associated with specific parameters Possible flags are listed in the Operator’ s Guide Morphology messages that have 1+, 2+, or 3+ are defined when you set the 1+ because after that, the computer determines the 2+ and 3+ so that results are standardized High (...
Page 167: Basic Troubleshooting
BASIC TROUBLESHOOTING OBJECTIVES When the subject is complete, you will be able to . . . Module and Component Identification Name each module. Locate and name module components. Sample Flow Find the aspiration hole in the Secondary mode probe. Explain the purpose of the venting pathway in the needle. Trace on the instrument the Primary mode aspiration pathway.
Page 168 BASIC TROUBLESHOOTING OBJECTIVES Reproducibility check: Explain the purpose of this check. State at least one situation when performing a reproducibility check would be beneficial. Carryover check: Explain the purpose of this check. State at least one situation when performing a carryover check would be beneficial. Replacement and Adjustment Procedures Locate and perform selected replacement and adjustment procedures such as replacing the needle.
Page 169 BASIC TROUBLESHOOTING MODULE AND COMPONENT IDENTIFICATION MODULE AND COMPONENT IDENTIFICATION CBC Module RBC vacuum WBC vacuum isolator chamber isolator chamber CBC lytic Waste reagent pumps chamber (1.0 mL total) FF16 aperture aperture bath bath Hemoglobin pre-amp Overflow chamber FF20 FF21 FF19 Hemoglobin lamp...
Page 170 BASIC TROUBLESHOOTING MODULE AND COMPONENT IDENTIFICATION BSV Module Bubble-maker pinch valves (2) Sheath tank Air pump Secondary mode aspiration pump 125 µL Primary mode aspiration pump 185 µL Blood detector (rear) Blood detector (front) Blood sampling valve (BSV) PN 4237530BB...
Page 171 BASIC TROUBLESHOOTING MODULE AND COMPONENT IDENTIFICATION Pump Module Erythrolyse II reagent pumps (2) 300 µL (total) PN 4237530BB...
Page 172 BASIC TROUBLESHOOTING MODULE AND COMPONENT IDENTIFICATION Autoloader Module Unload stack full sensor Load stack empty sensor Unload Load gate gate Position detect Position sensors detect sensors Load Unload elevator elevator Needle Tube available assembly sensor PN 4237530BB...
Page 173 BASIC TROUBLESHOOTING MODULE AND COMPONENT IDENTIFICATION Rotary Cap-Pierce Module Bar-code detectors Tube available sensor Hand (object) detect sensors Needle assembly PN 4237530BB...
Page 174 BASIC TROUBLESHOOTING MODULE AND COMPONENT IDENTIFICATION Flow Cell Module VCS electronics LASER LASER Flow cell Laser Mixing Module StabiLyse Mixing reagent pump chamber 133 µL PN 4237530BB...
Page 175 RBC diluent dispense pump 30 psi 10 mL regulator Vacuum trap Backwash pump 3 mL Sample pressure Sheath pressure regulator* regulator * Do not adjust the sample pressure unless directed to do so by your Beckman Coulter Technical Representative. PN 4237530BB...
Page 176 BASIC TROUBLESHOOTING MODULE AND COMPONENT IDENTIFICATION NOTES 8-10 PN 4237530BB...
Page 177 BASIC TROUBLESHOOTING SAMPLE FLOW SAMPLE FLOW Aspiration Aspiration 28 µL diff loop 1.6 µL RBC 28 µL WBC loop Blood is aspirated into the Blood Sampling Valve (BSV) 185 µL in the Primary mode (Closed-Vial mode) 125 µL in the Secondary mode (Open-Vial mode) To continue HmX Hematology Analyzer training, proceed to page 8-12.
Page 178 BASIC TROUBLESHOOTING SAMPLE FLOW Primary Mode Aspiration on a HmX Hematology Analyzer Front blood detector Primary mode Blood Bubble-maker aspiration pump detectors pinch valves (2) Side view 8-12 PN 4237530BB...
Page 179 BASIC TROUBLESHOOTING SAMPLE FLOW Primary Mode Aspiration on a HmX Hematology Analyzer - Step by Step The instrument puts the tube into the piercing position The bubble-maker pinch valves activate and pinch the tubing of the aspiration pathway, thus expelling a drop of diluent from the tip of the needle The bubble-maker pinch valves deactivate and an air bubble forms at the tip of the needle The needle pierces the tube’...
Page 180 BASIC TROUBLESHOOTING SAMPLE FLOW Primary Mode Aspiration on a HmX Hematology Analyzer with Autoloader Front blood detector Primary mode Bubble-maker Blood aspiration pump pinch valves (2) detectors Side view Aspiration tube 8-14 PN 4237530BB...
Page 181 BASIC TROUBLESHOOTING SAMPLE FLOW Primary Mode Aspiration on a HmX Hematology Analyzer with Autoloader - Step by Step The instrument puts the tube into the piercing position The bubble-maker pinch valves activate and pinch the tubing of the aspiration pathway, thus expelling a drop of diluent from the tip of the needle The bubble-maker pinch valves deactivate and an air bubble forms at the tip of the needle...
Page 182 BASIC TROUBLESHOOTING SAMPLE FLOW Piercing Needle Assembly Piercing needle Vent Sample aspiration (and backwash) Front support Vent port (and rinse) Bellows Aspiration (and backwash) Waste line Used for closed-vial sampling in the Primary mode Piercing needle has two ports: one for aspiration and a second for venting Vent port allows air to pass into (or out of) the stoppered specimen tube to equilibrate any residual vacuum or pressure inside the tube Aspiration port opens a pathway so that vacuum applied by the Primary mode aspiration...
Page 183 BASIC TROUBLESHOOTING SAMPLE FLOW Draining the Baths Waste chamber FF16 FF20 FF21 FF19 FF20 FF21 FF19 While a sample is aspirating, diluent from the last cycle’ s rinse drains to the waste chamber Locate the drain line at the bottom of each bath Trace this line through pinch valves 5 and 6 to the fittings on the back panel Pathway continues in back of CBC Module and up to the top where the lines come back out through fittings FF3 and FF5 which are located above the waste chamber...
Page 184 BASIC TROUBLESHOOTING SAMPLE FLOW Preparing the CBC Sample Air pump for diff transfer to sample line BSV (CBC Delivery) Diluent in Diluent in To WBC bath To RBC bath Diluent from large dispensers The center section of the BSV rotates to segment three portions of the sample: 1.6 µL for the RBC bath dilution 28.0 µL for the WBC bath dilution 28.0 µL for the Diff dilution...
Page 185 BASIC TROUBLESHOOTING SAMPLE FLOW CBC lytic reagent pumps Mixing bubble entry Dilution entry ports The dilutions are delivered to the aperture baths through the inlet ports on the upper right The CBC lytic reagent pumps send LYSE S III diff lytic reagent to join the WBC dilution on its way to the WBC bath Note: This lytic reagent lyses the RBCs and converts hemoglobin into a stable compound.
Page 186 BASIC TROUBLESHOOTING SAMPLE FLOW CBC Counting and Sensing vacuum vacuum isolator isolator chamber chamber The low vacuum supplied to the aperture baths to pull the diluted sample through the apertures is housed in the vacuum isolator chambers The RBC aperture senses red blood cells and platelets The WBC aperture senses white blood cells Hemoglobin is measured photometrically through the WBC bath 8-20...
Page 187 BASIC TROUBLESHOOTING SAMPLE FLOW Vacuum Aperture Internal current electrode External electrode Blood cell Sample suspension beaker Aperture current Aperture Aperture tube Vacuum Aperture housing Bath Internal electrode Aperture External electrode 8-21 PN 4237530BB...
Page 188 BASIC TROUBLESHOOTING SAMPLE FLOW Preparing the Diff Sample Mixes Erythrolyse II StabiLyse reagent pumps reagent pump The BSV rotates back to its original position The Diff lytic reagent pumps send Erythrolyse II reagent to pick up the diff blood segment from the line just behind the BSV and deliver it to the mixing chamber The first rotation of the mixing chamber occurs and the red blood cell membranes are ruptured and dissolved StabiLyse reagent is added to the mixing chamber during the second mixing process to...
Page 189 BASIC TROUBLESHOOTING SAMPLE FLOW From BSV StabiLyse reagent Mixing pump chamber To flow cell 8-23 PN 4237530BB...
Page 190 BASIC TROUBLESHOOTING SAMPLE FLOW Diff Analysis Vented waste Sample pressure Sheath Flow tank cell Sheath fluid Prepared sample Sample pressure applied to the mixing chamber pushes the Diff sample to the flow cell As the sample stream is pushed into the flow cell, alignment of the sample stream with the sheath fluid (hydrodynamic focusing) allows the white blood cells to pass one at a time through the flow cell aperture As each white blood cell passes through the aperture, the three independent VCS...
Page 191 BASIC TROUBLESHOOTING SAMPLE FLOW The Cycle Completes The RBC and WBC aperture baths drain into their waste chamber and a rinse of ISOTON III diluent enters the baths From the RBC diluent dispenser, 10.0 mL of diluent is dispensed via the BSV to the WBC bath From the WBC diluent dispenser, 6.0 mL of diluent is dispensed via the BSV to the RBC bath...
Page 192 BASIC TROUBLESHOOTING SAMPLE FLOW NOTES 8-26 PN 4237530BB...
Page 193 Use your knowledge of sample flow 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 8-27 PN 4237530BB...
Page 194 BASIC TROUBLESHOOTING BASIC TROUBLESHOOTING TECHNIQUES Troubleshooting by Instrument Subsystems Three instrument subsystems: Electronic Reagent Fluidic Pneumatics (pressures and vacuums) Hydraulics (liquids) Electronic Subsystem If there’ s no power, Check to see if the Standby indicator light is on or off Check power switches Check plug connections Check fuses (refer to the SPT Manual)
Page 195 If out of range on the low side, check the vacuum trap and clean as needed using the procedure in the SPT Manual If the vacuum trap is not the problem, call your Beckman Coulter Representative for assistance Low vacuum...
Page 196 60 psi Generated in the pneumatic power supply Is the source of 6 psi and 30 psi If out of range, call your Beckman Coulter Representative 30 psi Used for dispensing reagents from pumps, opening pinch valves, and moving air...
Page 197 BASIC TROUBLESHOOTING BASIC TROUBLESHOOTING TECHNIQUES Procedure is located in the Special Procedures and Troubleshooting (SPT) Manual, Chapter 2 Two procedures are available, one using the normal level of 5C cell control (Procedure A) and a second using normal whole blood (Procedure B) ↓...
Page 198 BASIC TROUBLESHOOTING BASIC TROUBLESHOOTING TECHNIQUES NOTES 8-32 PN 4237530BB...
Page 199 SUMMARY PAGES OVERVIEW What are Summary Pages? Each summary is an abbreviated reference of essential operating instructions detailed in the various instrument manuals. These abbreviated instructions are referred to as either summary pages or operational summaries. Purpose Each summary page is an individual, stand-alone document that is designed for use in your laboratory as a training aid and/or as a reference tool for a trained operator.
Page 200 SUMMARY PAGES CONTENTS Since these summary pages are designed to be used as stand-alone documents, consecutive page numbering was not used on these pages. Most operational summaries consist of either a single-side or a double-sided page. However, to accommodate the few summaries that are three or four pages long, the footer for each summary shows the total number of pages ⎯...
Page 201 CLEAN CYCLE SUMMARY 1 Perform the Clean Cycle From the Access screen, press Ë then press Û CLEAN 2 Let the Instrument Stand Cleaning agent remains in the instrument Leave instrument power on After 30 minutes, a Startup automatically begins 3 Review Results Once the startup cycles are complete, review the Summary screen and, if necessary, the System Status Values screen...
Page 203 RUNNING LATRON PRIMER AND CONTROL SUMMARY 1 Status for Proceeding Ensure Startup is complete LATRON Primer and Control must be at room temperature 2 Run LATRON Primer At the DMS From the Main Menu, select Controls Control Run If the LATRON file does not appear, press Ê and select your current Latex file File Press Ë...
Page 204 RUNNING LATRON PRIMER AND CONTROL SUMMARY Reviewing Control Results at the DMS Review results once the run appears on the Control Run screen If a result is out-of-limits, repeat the entire process beginning with LATRON Primer If the results of two control runs are unacceptable, Follow your laboratory’...
Page 205 RUNNING 5C CELL CONTROL SUMMARY 1 Getting the DMS Ready If SELECT FUNCTION is displayed If SELECT FUNCTION is not displayed From the Main Menu, select From the Main Menu, select Sample Sample Analysis Run Samples Analysis Run Samples Press Ë Note: Preparation for cycling in the Primary mode with the DIFF mode If DIFF mode is OFF , press Ñ...
Page 206 RUNNING 5C CELL CONTROL SUMMARY For both the HmX Hematology Analyzer with Autoloader and the HmX Hematology Analyzer If a result is out-of-limits, Follow your laboratory’ s protocol Refer to the table in the Operator’ s Guide When CBC/DIFF Control is Out of Limits Compare the results of this run with previous runs, as desired To evaluate stored numerical data, select Controls...
Page 207 RUNNING WHOLE BLOOD PATIENT SAMPLES SUMMARY Using a HmX Hematology Analyzer with Autoloader Running Whole Blood Samples in the Primary Mode 1 Getting the DMS Ready If not using the Worklist If SELECT FUNCTION is displayed, If SELECT FUNCTION is not displayed, From the Main Menu, select Sample From the Main Menu, select...
Page 208 RUNNING WHOLE BLOOD PATIENT SAMPLES SUMMARY 3 When the Run is Complete Verify all sample ID entries before reporting results Remove cassettes from the unloading bay If using the Worklist, periodically check for accumulation of Status messages Interrupting Primary Mode Operation to Run a STAT Press Ë...
Page 209 RUNNING WHOLE BLOOD PATIENT SAMPLES IN THE PRIMARY MODE SUMMARY Using a HmX Hematology Analyzer 1 Getting the DMS Ready If not using the Worklist If SELECT FUNCTION is displayed, If SELECT FUNCTION is not displayed, From the Main Menu, select From the Main Menu, select Sample Sample...
Page 210 RUNNING WHOLE BLOOD PATIENT SAMPLES IN THE PRIMARY MODE SUMMARY 2 Process the Sample With Bar-Code Labels Mix the specimen gently but thoroughly Hold the tube’ s bar-code label in front of the reader Listen for the beep and verify the green LED is glowing Confirm the ID appears in the Enter ID field Properly insert the specimen tube into the carousel Without Bar-Code Labels...
Page 211 RUNNING WHOLE BLOOD PATIENT SAMPLES IN THE SECONDARY MODE SUMMARY Using a HmX Hematology Analyzer Getting the DMS Ready If not using the Worklist If using the Worklist From the Main Menu, select Sample From the Main Menu, select Sample Analysis Run Samples Analysis...
Page 213 RUNNING PATIENT SAMPLES IN THE PREDILUTE MODE SUMMARY For HmX Hematology Analyzer with Autoloader and HmX Hematology Analyzer Getting the DMS Ready If not using the Worklist If using the Worklist From the Main Menu, select From the Main Menu, select Sample Sample Analysis...
Page 215 DATA BASE QUERY QUICK REFERENCE GUIDE If the SELECT FUNCTION prompt isn’t displayed, press Ñ STOP From the Main Menu, select Sample Analysis Data Base Query To Sort Sample Data Press Î Sort if the Sort window is not displayed Select the group of samples you want to review or work on To find samples run during a certain time period, enter the DATE and TIME in the appropriate FROM and TO fields (enter “00”...
Page 216 DATA BASE QUERY QUICK REFERENCE GUIDE To Edit Sample Data Execute a sort Use æ or ç to highlight the sample to be edited Press Ë Edit to view all the identifiers that were entered from the Worklist and/or read from a bar-code label as well as the individual parameter results Press ã...
Page 217 DATA BASE QUERY QUICK REFERENCE GUIDE To Output Sample Data: Print and Reprint / Transmit and Retransmit To Print a Single Sample Data Set Execute a sort Use æ or ç to highlight the desired sample → the Run Samples display of this sample’ s results, scatterplot, and Press Ô...
Page 218 DATA BASE QUERY QUICK REFERENCE GUIDE To Archive a Group of Stored Sample Results Execute a sort Tag the desired samples using Ï or Ð Tag All Press Í Batch Move the cursor to the Archive field then press Ê Choice List Use the ß...
Page 219 STARTUP SUMMARY 1 Check Current Instrument Status If the power is off, turn it on If the Main unit is in Standby, switch it to Ready If the DMS monitor is dark, press ß If Startup results are already displayed as the result of a Clean Cycle, go to step 3; if not, enter your three character Operator ID (optional) From the Main Menu, press Í...
Page 221 SHUTDOWN SUMMARY 1 Perform Shut Down Verify SELECT FUNCTION is displayed on the status line From the Main Menu, select Diluter Functions Shut Down Press Û 2 Let the Instrument Stand Allow cleaning agent to remain in the instrument a minimum of 30 minutes Leave instrument power on Note: If the power is turned off and the instrument is going to be idle for more than 48 hours, do the Prolonged Shutdown Procedure in the Operator’...
Page 223 RUNNING RETIC-C CELL CONTROL SUMMARY 1 Prepare Controls according to the Package Insert Warm controls at room temperature 10 to 15 minutes Mix each control tube using the 8 x 8 x 8 method once Do not use a mechanical mixer 2 Preparing the Control For each control tested, label two 12 x 75 mm test tubes "A"...
Page 225 RUNNING SAMPLES IN THE RETIC MODE SUMMARY For HmX Hematology Analyzer with Autoloader and HmX Hematology Analyzer 1 Preparing the Sample For each patient tested, label two 12 x 75 mm test tubes with the patient’ s ID then label one tube "A"...
Page 227 MAKING CHANGES TO A CONTROL FILE CURRENTLY IN USE Use only if you want to make a change in a control file that is currently in use. This summary should be used when changing individual items in a previously set up control file, such as entering a running mean or correcting a typographical error.
Page 229 CONTROL FILE MANAGEMENT SUMMARY Using the Default Limits/Expected Range from the Package Insert Note: To maintain customized expected ranges in a control file, use the Control File Management Using Your Laboratory’s Custom Ranges Summary Review the Numeric Control Data and Graphs, if applicable Locate the Control File From the Main Menu, select Controls...
Page 230 CONTROL FILE MANAGEMENT SUMMARY Setting Up a 5C Cell Control File Select the File From the Main Menu, select Special Functions Set Up Control set up CBC/DIFF file Move the cursor to a NOT SETUP file or an inactive file where the control run data is deleted then press Û...
Page 231 CONTROL FILE MANAGEMENT SUMMARY Setting Up a RETIC File Select the File From the Main Menu, select Special Functions Set Up Control set up RETIC file Move the cursor to a NOT SETUP file or an inactive file where the control run data is deleted then press Û...
Page 233 CONTROL FILE MANAGEMENT SUMMARY Using Your Laboratory’s Custom Ranges Use this summary only if you want to maintain the customized expected ranges previously entered in an existing control file (typically a 5C control file). Review the Numeric Control Data and Graphs, if applicable Locate the Control File From the Main Menu, select Controls...
Page 234 CONTROL FILE MANAGEMENT SUMMARY Upload the 5C Control Assay Values Insert the 5C cell control diskette into the A: drive of the computer Press Í Upload Assay Values Press the function key for the desired level of control Type Manual Entries Select the Shift and manually type the Operator ID Verify All Information Make sure the Host transmit setting correlates with your laboratory’...
Page 235 CHANGING REAGENTS SUMMARY 1 Record the New Reagent Information From the Main Menu, select Special Functions Set Up System Set Up Reagents Enter the lot number and the expiration date or open container stability date, as applicable The date opened automatically changes to today’ s date when the lot number is entered (this is the reason the lot number should always be typed even if it is the same as the last container) Six digits must be entered for the expiration date or open container stability date...
Page 237 REPLACING A WASTE CONTAINER SUMMARY 1 Put the Instrument into Standby Move the Standby/Reset rocker switch to Standby, position 2 Turn OFF the Main Power Use the Main POWER On /Off rocker switch located on the back of the Main Unit 3 Replace the Waste Container Using biohazardous precautions, Remove the waste assembly from the full container...
Page 239: Training Checklist
TRAINING CHECKLIST OFFICIAL TRAINING DOCUMENTATION (for COULTER HmX Hematology Analyzer with Autoloader or HmX Hematology Analyzer Training) Laboratory Address Phone HmX Serial Number Key Operator Training Dates Instructions The overall objectives for COULTER HmX Hematology Analyzer with Autoloader or COULTER HmX Hematology Analyzer Key Operator training are listed below. Each objective is a comprehensive statement of what an operator should be able to do when training is complete.
Page 240 TRAINING CHECKLIST OFFICIAL TRAINING DOCUMENTATION _______ Perform appropriate Quality Control checks _______ Review, delete, and set up control files _______ Download IQAP data, if applicable _______ Perform all preliminary procedures required for calibration _______ Perform the CBC Calibration with S-CAL Calibrator and document the results according to your laboratory’...
Page 241 TRADEMARKS Beckman Coulter, The BECKMAN COULTER logo, COULTER, LYSE S, COULTER CLENZ, 5C, 4C, and LIN-C are trademarks of Beckman Coulter, Inc.; Beckman Coulter, COULTER, LYSE S, COULTER CLENZ, 5C, 4C, and LIN-C are registered in the USPTO and SIPO.

Beckman Coulter COULTER HmX Operator Training Manual

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