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1. Beckman Coulter Procedure Manual
2. Beckman Coulter Instructions For Use

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Beckman Coulter Procedure Manual

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Summary of Contents for Beckman Coulter COULTER HmX

Beckman Coulter Instructions For Use

• Page 1 COULTER HmX Hematology Analyzer Operator’s Guide ECKMAN OULTER ® PN 4237519CB (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 4237519CB..

• Page 5: Table Of Contents

  CONTENTS REVISION STATUS, iii INTRODUCTION, xi HOW TO USE YOUR COULTER HmX HEMATOLOGY ANALYZER DOCUMENTATION SET, xi ABOUT THIS MANUAL, xi CONVENTIONS, xii HOT KEYS (SHORTCUTS), xii SYSTEM OVERVIEW, 1-1 HmX MAIN UNIT COMPONENTS, 1-1 COMPUTER, MONITOR AND KEYBOARD, 1-2..
• Page 6 CONTENTS XB ANALYSIS, 2-24 XB Theory, 2-24 Target Values, 2-24 Current XB Batch, 2-25 XB Batch Means, 2-25 XB Graphs, 2-26 IQAP , 2-27 DIFFERENTIAL COMPARISON PROCEDURE, 2-27 SAMPLE ANALYSIS, 3-1 CBC/DIFF SPECIMEN COLLECTION, 3-1 CBC/DIFF SPECIMEN STORAGE, 3-1 BAR-CODE LABELING, 3-2 TUBE ADAPTERS, 3-2 PREASSIGNING THE WORKLIST, 3-3 SAMPLE INTEGRITY CHECKS, 3-3..
• Page 7 CONTENTS DIFF SCATTERPLOTS AND HISTOGRAMS, 4-3 DF1, 4-3 DF2, 4-4 DF3, 4-4 VCS Histograms, 4-5 RETICULOCYTE SCATTERPLOTS, 4-6 DF5, 4-6 DF6, 4-6 PARAMETER CODES, 4-7 Retic Parameter Codes, 4-9 MESSAGES, 4-9 Condition Messages, 4-11 Suspect Messages, 4-11 Definitive Messages, 4-12 MICROSCOPIC REVIEW, 4-13 DATA BASE QUERY, 4-14 Overview, 4-14..
• Page 8 CONTENTS CONTROL SET UP , 6-2 CBC/DIFF file, 6-2 Latex file, 6-3 CBC file, 6-4 RETIC file, 6-4 Auto-Stop, 6-4 SAMPLE ANALYSIS SET UP , 6-6 Action limits, 6-6 XB limits, 6-6 Definitive flag limits, 6-6 High/low flag limits, 6-7 Laboratory Normal Ranges, 6-7 Location list, 6-8 Physician list, 6-8..
• Page 9 CONTENTS TABLES F5 from Run Samples Screen, 1-5 Status Line Definition, 1-6 When LATRON Control is Out of Limits, 2-6 When CBC/DIFF Control is Out of Limits, 2-9 When Retic Control is Out of Limits, 2-17 Parameter Codes, 4-7 Retic Parameter Codes, 4-9 Summary of Flagging Messages, 4-10 Origin of Abnormal Pop Messages, 4-11 Definitive Flagging Limits, 4-12..
• Page 10 CONTENTS PN 4237519CB..

• Page 11: Introduction

  INTRODUCTION This introductory section contains the following topics: How to use your COULTER HmX Hematology Analyzer Documentation set About this Manual Conventions Hot Keys HOW TO USE YOUR COULTER HmX HEMATOLOGY ANALYZER DOCUMENTATION SET Use the Reference manual for in-depth information about what the instrument does, the methods it uses, its specifications, and information on installation, safety and software options.

• Page 12: Conventions

  INTRODUCTION CONVENTIONS Chapter 4, Data Review Contains information about reviewing the data on the Run Samples screen such as histograms, scatterplots, parameter codes, flags, and messages. Also presents information on Data Base Query and Workload Recording. Chapter 5, Shut Down Contains step-by-step instructions for shutting down your system for short or prolonged periods.

• Page 13: System Overview

  SYSTEM OVERVIEW HmX MAIN UNIT COMPONENTS ECKMAN OULTER POWER COMPUTER AC AC INPUT ® Aspirator probe. Use this to aspirate from open vials, predilute specimens, and retic preparations. Sample bar. Press this to start aspiration from an open vial, predilute specimen, or retic preparation.

• Page 14: Computer, Monitor And Keyboard

  SYSTEM OVERVIEW COMPUTER, MONITOR AND KEYBOARD COMPUTER, MONITOR AND KEYBOARD EXIT MENU ON/OFF VOLUME BASS TREEBLE MAX MIN MAX MIN MAX MIN ON OFF Note: The design of your computer and monitor may differ from this illustration. If so, refer to the manufacturer’ s documentation for information on controls and indicators. Monitor power indicator light.

• Page 15: Access Screen

  COULTER(R) HmX HEMATOLOGY ANALYZER CLEAN SAMPLES CONTROLS DATA BASE HOST MAIN WORKLIST QUERY WORKLIST MENU This program is protected by U.S. and International laws as described in the manual. (C) Copyright Beckman Coulter Inc., 1999 02/28/99 10:14 SELECT FUNCTION PN 4237519CB..

• Page 16: Software Menu Tree

  SYSTEM OVERVIEW SOFTWARE MENU TREE SOFTWARE MENU TREE The Main Menu consists of the four items listed across the top of the menu tree: , and Sample Analysis Controls Diluter Functions Special Functions Sample Analysis Controls Diluter Functions Special Functions Workload recording Multiple Aperture Zap Prime Reagents..

• Page 17: Run Samples Screen Options

  SYSTEM OVERVIEW RUN SAMPLES SCREEN OPTIONS RUN SAMPLES SCREEN OPTIONS Í Optns: N=2 IN CAP PIERCER 10mm-13mm Print: NONE Host: Display only: OFF Operator: OPR B&W screen print Color screen print Table 1.1 F5 from Run Samples Screen F2 XB: ON N=2 Turns XB ON and OFF.

• Page 18: Status Line

  SYSTEM OVERVIEW STATUS LINE STATUS LINE The status line at the bottom of your screen indicates the current operating status of the HmX Hematology Analyzer. 07/13/99 19:34 Table 1.2 Status Line Definition ↑ ↓ Symbol Refers to Yellow White Data Connected to Not connected DMS busy or..

• Page 19: Startup And Controls

  STARTUP AND CONTROLS IMPORTANT Operating the HmX Hematology Analyzer with open doors or panels introduces electrical interference which can cause misleading results. Operate the HmX Hematology Analyzer with all doors and panels closed. STARTUP Are Start Up results already displayed as the result of a Clean cycle? If no, go to step 2.

• Page 20: Control Run

  STARTUP AND CONTROLS CONTROL RUN CONTROL RUN Preparation Ensure that a control file is set up for each control you intend to run. If you need to set up a control file, refer to Heading 6.2, Control Set Up. LATEX Analyze COULTER LATRON primer and control once each day.
• Page 21 STARTUP AND CONTROLS CONTROL RUN Press Ë Ì PRIMER SAMPLE MODE? CONTROL (SECONDARY) PRIMER PURGE RINSE STOP Select to change/ESC to continue Cycle the primer (bottle 1): IMPORTANT Removing the primer bottle before you hear the beep can cause falsely increased primer results.
• Page 22 STARTUP AND CONTROLS CONTROL RUN Evaluate primer results: Are both counts < 500? If yes, go to step 7. If no, go to step 6b. Cycle a new vial. Make sure it is free of bubbles. Are both counts < 500? If yes, go to step 7.
• Page 23 STARTUP AND CONTROLS CONTROL RUN 10. Cycle the control (bottle 2): IMPORTANT Removing the control bottle before you hear the beep can cause misleading control results. Do not remove the control bottle until you hear the beep. Immerse the aspirator tip completely in the control.

• Page 24: When Latron Control Is Out Of Limits

  5. If the problem remains, either: Perform Shutdown or Turn the DIFF OFF and run CBCs only then call your Beckman Coulter representative for help. There is an instrument change. Call your Beckman Coulter Representative for help. PN 4237519CB..

• Page 25: Cycling Coulter 5c Cell Controls In Primary Mode With Bar-code Labels

  STARTUP AND CONTROLS CONTROL RUN Cycling COULTER 5C Cell Controls in Primary Mode with Bar-Code Labels COULTER 5C cell control, with bar-code labels, is the recommended method of QC. Your HmX Hematology Analyzer automatically recognizes bar code-labeled 5C cell controls and assigns results to the correct file.
• Page 26 STARTUP AND CONTROLS CONTROL RUN Make sure the DIFF is ON. If it is OFF , SAMPLE MODE? press Î DIFF ON/OFF START PRIMARY SECONDARY PREDILUTE CBC Note: If SAMPLE MODE? is not displayed, RETIC press Ñ STOP first. DIFF ON/OFF PURGE RINSE STOP..

• Page 27: When Cbc/diff Control Is Out Of Limits

  STARTUP AND CONTROLS CONTROL RUN Place the control in the carousel. Results are placed automatically in the correct file. Results do not appear on the Run Samples screen. If any result is out of control, an error message displays. 10. Repeat steps 7 through 9 for other levels of control.

• Page 28: Cycling Commercial Cell Controls Without Bar-code Labels

  STARTUP AND CONTROLS CONTROL RUN Cycling Commercial Cell Controls without Bar-Code Labels Follow the directions on the cell control package insert for storage, preparation and mixing. Access the appropriate Control Run screen: at the Access screen, press Ê RUN CONTROLS at the Main Menu, select Controls tt Control Run..

• Page 29: Cycling 5c Cell Control In The Secondary Mode

  STARTUP AND CONTROLS CONTROL RUN Check for H (High) or L (Low) beside the results on the screen. If there are no H's or L's, results are within range. If you see an H or L, go to Table 2.2. Follow the troubleshooting steps until you solve the problem.
• Page 30 STARTUP AND CONTROLS CONTROL RUN Press Ë Ë SECONDARY Mix the control tube according to package insert directions. Cycle the control: Open the tube and immerse the aspirator tip into the sample. Press and release the sample bar. Remove the tube when you hear the beep.

• Page 31: Coulter Retic-c Cell Control

  CONTROL RUN COULTER Retic-C Cell Control Retic-C cell control is a hematology reference control that monitors Beckman Coulter systems with reticulocyte technology using VCS (volume, conductivity, and light scatter). Use Retic-C cell controls, Levels I, II and III, with the COULTER ReticPrep Reagent kit.
• Page 32 STARTUP AND CONTROLS CONTROL RUN IMPORTANT Dispensing Reagent A at an angle changes the dilution of the preparation. Dispense the drops of Reagent A vertically. Place four drops of Reagent A into the test tube labeled 'A.' Dispense 50 µL of well-mixed control into the tube labeled 'A.'..
• Page 33 STARTUP AND CONTROLS CONTROL RUN Gently mix tube 'A.' Prepare other levels of control using steps 1 through 5. Let stand for at least 5 minutes at room temperature. Up to 60 minutes is allowable. Access the appropriate Control Run screen: at the Access screen, press Ê..
• Page 34 STARTUP AND CONTROLS CONTROL RUN IMPORTANT To ensure accurate results, add the control-stain mixture directly to the bottom of the tube; do not allow control-stain mixture to run down the sides of the tube. To prevent drying of this small amount, proceed immediately to the next step. 10.

• Page 35: When Retic Control Is Out Of Limits

  STARTUP AND CONTROLS CONTROL RUN 13. After 30 seconds, analyze the control. Immerse the aspirator tip into the retic preparation. Press and release the sample bar. Remove the tube when you hear the beep. 14. Check for H (High) or L (Low) beside the results on the screen.

• Page 36: Control Review Or Report

  STARTUP AND CONTROLS CONTROL REVIEW OR REPORT CONTROL REVIEW OR REPORT Select Controls tt Review or Report Use to review and print: Control results, cumulative statistics and histograms for LATEX files. Control results, cumulative statistics and graphics for CBC/DIFF and RETIC files. Control results and cumulative statistics for CBC files.
• Page 37 STARTUP AND CONTROLS CONTROL REVIEW OR REPORT Î Diff Latex Control Review screen Rem/Res Removes a highlighted run from the calculations. DEL appears in place of the run number. The statistics recalculate. Pressing Î again restores the run and original statistics. Note: This does not apply to Primer runs.

• Page 38: Cbc/diff Control Review Or Report

  STARTUP AND CONTROLS CONTROL REVIEW OR REPORT CBC/DIFF Control Review or Report Use to review and print control results, cumulative statistics, and graphics for CBC/DIFF files. Can also be used to transmit the data of the entire control file to a host computer.

• Page 39: Retic Control Review Or Report

  STARTUP AND CONTROLS CONTROL REVIEW OR REPORT Retic Control Review or Report Use to review and print control results, cumulative statistics, and graphics for Retic files. Can also be used to transmit the data of the entire control file to a host computer. Check cumulative results to look for trends, shifts, or, if necessary, troubleshooting.

• Page 40: Cbc Control Review Or Report

  STARTUP AND CONTROLS CONTROL REVIEW OR REPORT CBC Control Review or Report Use to review and print control results and cumulative statistics for CBC files. Can also be used to transmit the data of the entire control file to a host computer. Check cumulative results to look for trends, shifts, or, if necessary, troubleshooting.

• Page 41: Control Graphs

  STARTUP AND CONTROLS CONTROL GRAPHS CONTROL GRAPHS Select Controls tt Graphs Control results are plotted on Levey-Jennings graphs. Review as necessary to check for shifts and trends. Note: MRV and IRF graphs only appear on the Retic Control graph screen if you enabled these parameters.

• Page 42: Mode To Mode

  MODE TO MODE MODE TO MODE Beckman Coulter recommends that you perform a mode to mode quality-control check at intervals established by your laboratory. Run a normal whole blood sample multiple times in both the Primary and Secondary modes and compare the mean results. For an N of 10, the mean results should compare within the limits listed below.

• Page 43: Current Xb Batch

  STARTUP AND CONTROLS XB ANALYSIS Current XB Batch Select Sample Analysis Current XB Batch When XB is ON, the DMS stores the RBC parameter results of all patient samples as they are cycled. These results display on the Current XB Batch screen. When a batch of 20 samples is collected, the DMS performs XB analysis and calculates the batch mean for MCV, MCH and MCHC.

• Page 44: Xb Graphs

  STARTUP AND CONTROLS XB ANALYSIS Screen-Specific Function Keys: Ì Print Prints the table. Î Delete Last Batch Deletes the last batch. Delete only if the batch is so badly skewed because of non-random sampling or an instrument problem that it will adversely affect many later batches.

• Page 45: Iqap

  IQAP The Interlaboratory Quality Assurance Program (IQAP) both complements and enhances your laboratory’ s in-house quality control. It is a service offered to users of Beckman Coulter Hematology cell controls and calibrators worldwide. The IQAP manual (PN 4206266 for 4C Plus, 5C and Retic-C cell controls) presents information on program enrollment, data entry, the IQAP report, quality control concepts, and answers to the most commonly asked questions about the program.
• Page 46 STARTUP AND CONTROLS DIFFERENTIAL COMPARISON PROCEDURE 2-28 PN 4237519CB..

• Page 47: Sample Analysis

  SAMPLE ANALYSIS CBC/DIFF SPECIMEN COLLECTION 1,2,3 Collect whole blood in a salt of EDTA according to procedures in: NCCLS publication H4-A3, NCCLS publication H3-A3. IMPORTANT If you do whole-blood calibration, you must use the same salt of EDTA for patient samples that you use for calibration.

• Page 48: Bar-code Labeling

  SAMPLE ANALYSIS BAR-CODE LABELING BAR-CODE LABELING IMPORTANT 1. Blood, scratches and powder from gloves reduces bar-code read rate. Keep the bar-code label free of blood, scratches and powder from gloves to maintain a high-read rate. 2. Risk of misidentification. Do not use the tilde (~) character in demographics, including Specimen or Patient ID.

• Page 49: Tube Adapters

  SAMPLE ANALYSIS TUBE ADAPTERS TUBE ADAPTERS Round-bottom tube adapters can be used for: 2mL (10.25mm X 47 mm) or 3mL (10.25 mm X 64 mm) sample tubes. You can use a maximum of two labels in addition to the sample tube manufacturer’..

• Page 50: Cycling Samples In The Primary Mode

  SAMPLE ANALYSIS CYCLING SAMPLES IN THE PRIMARY MODE Valve (BSV). These blood detectors optically sense air bubbles, diluent, and blood. As an indication of a good aspiration, the system looks for blood in both detectors. If the detectors optically identify bubbles in the sample, the instrument pierces the tube a second time. If the second aspiration contains bubbles, the instrument reports a partial aspiration.
• Page 51 SAMPLE ANALYSIS CYCLING SAMPLES IN THE PRIMARY MODE IMPORTANT Running out of reagent will cause erroneous results. The reagent sensors are designed to Reagent Sensors Off alert you before you run out. If you disable reagent sensors, the message appears on the screen and on graphic printouts.
• Page 52 SAMPLE ANALYSIS CYCLING SAMPLES IN THE PRIMARY MODE Does the top of the F3-Run window PRIMARY: SAMPLE ANALYSIS display PRIMARY: SAMPLE ANALYSIS START PRIMARY If yes, press È SECONDARY If no, press Ê PREDILUTE CBC START PRIMARY RETIC DIFF ON/OFF PURGE RINSE STOP..

• Page 53: Cycling Samples In The Secondary Mode

  SAMPLE ANALYSIS CYCLING SAMPLES IN THE SECONDARY MODE Enter 1 to 16 alphanumeric characters then press Û. Place the well-mixed blood sample in the carousel. Review the results. Refer to Chapter 4, Data Review, for information on the Run Samples screen, scatterplots, histograms, parameter codes and flags and messages.
• Page 54 SAMPLE ANALYSIS CYCLING SAMPLES IN THE SECONDARY MODE Press Ë SAMPLE MODE? If necessary, press Î DIFF ON/OFF START PRIMARY change the DIFF setting. SECONDARY PREDILUTE CBC RETIC Note: If SAMPLE MODE? is not displayed, DIFF ON/OFF press Ñ PURGE first.
• Page 55 SAMPLE ANALYSIS CYCLING SAMPLES IN THE SECONDARY MODE Mix according to the tube manufacturer’ s instructions. Identify the sample: Hold the tube’ s bar-code label in front of the reader. Green light and beep: Bar code read. Go to step 7. Red light: Wait.

• Page 56: Cycling Samples In The Predilute Mode

  SAMPLE ANALYSIS CYCLING SAMPLES IN THE PREDILUTE MODE CYCLING SAMPLES IN THE PREDILUTE MODE Use the Predilute mode to do a repeat analysis of microcollection samples when less than 125 µL of sample remains. Only CBC results are reported on a Predilute mode sample. The Predilute mode requires a 1:3 (X3) dilution.
• Page 57 SAMPLE ANALYSIS CYCLING SAMPLES IN THE PREDILUTE MODE IMPORTANT Blood detectors are inactive in Predilute mode. Sample and aspiration integrity are not checked. To avoid misleading results, ensure complete immersion of the aspirator tip in the dilution. Do not remove the tube until you hear the beep. Label a clean empty tube with an ID number.
• Page 58 SAMPLE ANALYSIS CYCLING SAMPLES IN THE PREDILUTE MODE IMPORTANT Incomplete aspiration will cause erroneous results. Tilt the tube as shown to ensure full aspiration. Cycle the dilution: Immerse the aspirator tip into the dilution. Press and release the sample bar. Remove the tube when you hear the beep.

• Page 59: 3.10 Cycling Samples In The Retic Mode

  SAMPLE ANALYSIS CYCLING SAMPLES IN THE RETIC MODE 3.10 CYCLING SAMPLES IN THE RETIC MODE Retic Specimen Collection Collect whole blood in a salt of EDTA according to procedures in: NCCLS publication H4-A3, or NCCLS publication H3-A3. Use of other anticoagulants can give misleading results. Retic Specimen Storage Store specimens capped and: If stored at room temperature, run within 8 hours.
• Page 60 SAMPLE ANALYSIS CYCLING SAMPLES IN THE RETIC MODE Place four drops of Reagent A into the test tube labeled 'A.' Dispense 50 µL of well-mixed sample into the tube labeled 'A.' Do not let the blood run down the sides of the tube. 50 µL 3-14 PN 4237519CB..

• Page 61: Retic Sample Analysis

  SAMPLE ANALYSIS CYCLING SAMPLES IN THE RETIC MODE Gently mix tube 'A.' Prepare other patient samples using steps 1 through 5. Let stand for at least 5 minutes at room temperature. Up to 60 minutes is allowable. Retic Sample Analysis Access the Run Samples screen: at the Access screen, press É..
• Page 62 SAMPLE ANALYSIS CYCLING SAMPLES IN THE RETIC MODE Gently mix tube 'A' again then transfer 2 µL of the blood/stain mixture from tube 'A' into the bottom of tube 'B.' 2 µL 3-16 PN 4237519CB..
• Page 63 SAMPLE ANALYSIS CYCLING SAMPLES IN THE RETIC MODE IMPORTANT To ensure accurate results, allow Reagent B to run down the side of the tube so that no foaming or bubbles occur, but rapidly enough to mix the blood-stain mixture and Reagent B. Do not do any additional mixing.
• Page 64 SAMPLE ANALYSIS CYCLING SAMPLES IN THE RETIC MODE Review the results. Refer to Chapter 4, Data Review, for information on the retic scatterplot and parameter codes and flags. Note: MRV and IRF results only appear on the screen if you enabled these parameters.

• Page 65: 3.11 Worklist

  SAMPLE ANALYSIS WORKLIST 3.11 WORKLIST The purpose of the Worklist is to assign additional sample identifiers such as patient name and demographics, or additional information such as comments, before you cycle the sample. This additional information prints on the report and is stored in the database with the results. Worklist entries such as demographic data are best entered in batches.

• Page 66: Preassigning The Worklist

  SAMPLE ANALYSIS WORKLIST Use the Û key to move from field to field and set up the items you want to automatically sequence. ß toggles between ON and OFF . Type in the starting number for each item you choose to autosequence.

• Page 67: Status Messages

  SAMPLE ANALYSIS WORKLIST Do you want to add demographics and/or comments? If no, go to step 6. If yes, continue with this step. Press Ë Comments Type in demographic data and comments. Verify that the entries are correct. Entries made during sample processing or while the instrument is transmitting data might..
• Page 68 SAMPLE ANALYSIS WORKLIST NO MATCH This message means that the ID#1 of the cycled sample did not match any of the ID#1 entries on the Worklist. The most common cause is a typing error when entering the ID#1 either on the Worklist or just prior to cycling.

• Page 69: 3.12 Host Worklist

  SAMPLE ANALYSIS HOST WORKLIST 3.12 HOST WORKLIST The Host Worklist receives sample identifiers and demographics from your host computer. The Host Worklist can hold up to 5,000 samples. Tag and transfer samples to the Worklist when you are ready to cycle them. The Worklist can accept up to 300 samples from the Host Worklist.
• Page 70 SAMPLE ANALYSIS HOST WORKLIST 3-24 PN 4237519CB..

• Page 71: Data Review

  DATA REVIEW RUN SAMPLES DISPLAY Status Line Monocyte Population Option (Function) Line Neutrophil Population Eosinophil Population Condition Messages RBC Histogram Mode P = Primary S = Secondary PrD = Predilute RET = Retic PLT Histogram Date and Time of Analysis CBC Parameter Results Barcode or Keyboard Entry Identification Diff Results..

• Page 72: Cbc Histograms

  DATA REVIEW CBC HISTOGRAMS CBC HISTOGRAMS RBC Distribution Curve The normal RBC curve ranges from 36 to 360 fL. The display starts at 24 fL. Plt Distribution Curve The normal Plt distribution yields two curves, both using averaged data. The smooth curve derives from raw data and displays between 2 fL and 20 fL.

• Page 73: Diff Scatterplots And Histograms

  DATA REVIEW DIFF SCATTERPLOTS AND HISTOGRAMS DIFF SCATTERPLOTS AND HISTOGRAMS HmX PAK reagents maintain white cells in their near-native state. The instrument looks at cells in all three dimensions. You see results on your screen two dimensions at a time in three different views.

• Page 74: Df2

  DATA REVIEW DIFF SCATTERPLOTS AND HISTOGRAMS Press Î then Þ+Ê to rotate the cube to the DF2 display. Here the horizontal spread derives primarily from conductivity. Lymphocyte Population Monocyte Population Neutrophil, Basophil, and Eosinophil Populations Now press Þ+Ë to display the DF3 view which shows the Neutrophils and Eosinophils gated out to reveal the Basophils.

• Page 75: Vcs Histograms

  DATA REVIEW DIFF SCATTERPLOTS AND HISTOGRAMS VCS Histograms Þ+Ì displays histograms that show the distribution of volume conductivity scatter across the horizontal axis. PN 4237519CB..

• Page 76: Reticulocyte Scatterplots

  DATA REVIEW RETICULOCYTE SCATTERPLOTS RETICULOCYTE SCATTERPLOTS DF5 is always the initial display. The horizontal spread displays the amount of light scatter, which is the primary counting/separating device. Mature Red Blood Cell Population Reticulocyte Population Press Î then Þ+Ê to view DF6. The horizontal spread displays the amount of opacity, which is primarily used as a gating device to screen out all non-reticulocyte/red..

• Page 77: Parameter Codes

  DATA REVIEW PARAMETER CODES PARAMETER CODES Table 4.1 lists the parameters and their codes. If any of the following flags occur, review the results for the affected parameter. Table 4.1 Parameter Codes On DMS Display Cause All Parameters • • • • • for a parameter result Incomplete or abnormal computation.

• Page 78: Parameter Codes

  DATA REVIEW PARAMETER CODES Table 4.1 Parameter Codes (Continued) On DMS Display Cause All Parameters L next to parameter result Result is lower than the laboratory-set patient low action limit or below the assay control lower limit. H next to parameter result Result is higher than the laboratory-set patient high action limit or above the assay control upper limit.

• Page 79: Retic Parameter Codes

  DATA REVIEW MESSAGES Retic Parameter Codes Table 4.2 lists the parameters and their codes. If any of the following flags occur, review the results for the affected parameter. Table 4.2 Retic Parameter Codes Message in Code Under Results Message Box Scatterplot Situation :::::..

• Page 80: Summary Of Flagging Messages

  DATA REVIEW MESSAGES Note the following circumstances: An overrange (+++++) parameter result does not generate a definitive message but does generate an abnormal population condition message. With a colon (:::::) code for the differential results, if the WBC count exceeds the limits for Leukopenia or Leukocytosis, then these definitive messages appear and an abnormal population condition message occurs.

• Page 81: Condition Messages

  DATA REVIEW MESSAGES Condition Messages Population condition messages appear in the lower left corner of the Run Samples screen. They are: Normal WBC Pop Abnormal WBC Pop Normal RBC Pop Abnormal RBC Pop Normal Plt Pop Abnormal Plt Pop If there is a voteout for WBC, RBC or Plt, no message appears for the respective parameter. The system generates these population messages from one or a combination of the following: suspect messages, definitive messages or meeting the criteria of an internal algorithm that does not report a separate flag.

• Page 82: Definitive Messages

  DATA REVIEW MESSAGES Definitive Messages Set definitive flags at 'decision limits' to trigger Abnormal Pop condition messages to appear when results exceed your laboratory's defined limits (low and high). Use definitive flags to denote moderate to seriously abnormal distributions. See Chapter 6, Set Up for instructions on setting limits.

• Page 83: Microscopic Review

  DATA REVIEW MICROSCOPIC REVIEW Table 4.5 Definitive Flagging Limits (Continued) For this Parameter This Message Indicates the Result Exceeds this Limit 1+ Hypochromia Low limit for MCH 2+ Hypochromia A gradient range from 1+ Hypochromia 3+ Hypochromia A gradient range from 2+ Hypochromia 1+ Poikilocytosis High limit for RDW and Low limit for MCH 2+ Poikilocytosis..

• Page 84: Data Base Query

  DATA REVIEW DATA BASE QUERY DATA BASE QUERY To access the Data Base Query screen: at the Access screen, press Ì DATA BASE QUERY at the Main Menu, select Sample Analysis tt Data Base Query Overview You can sort, retrieve, review, print, transmit, archive to diskette and mark for saving sample results you previously stored.
• Page 85 DATA REVIEW DATA BASE QUERY Each data line has fields for the following information about a sample: A pointer character if the sample is tagged ID #1 The secondary identifier (ID #2), if one has been entered, for example, a name. Date and time of cycle Sample mode P = Primary..
• Page 86 DATA REVIEW DATA BASE QUERY After you press Ë Edit , the Sample Results screen appears. The function key options on this screen are: Ê Choice Lists When you move the cursor to the field, displays location or physician's choice list.
• Page 87 DATA REVIEW DATA BASE QUERY Í Batch Print tagged results in graphic format Transmit tagged results to the host computer or Archive tagged results to diskette. More information on each of these features is presented later in this section. When the F5 Batch window is displayed, you have these function keys:..

• Page 88: Sorting

  DATA REVIEW DATA BASE QUERY Sorting Î Sort Displays the sort criteria window. Select the group of samples you want to review. The maximum number of samples that can be selected for sort is 1,000. If you have more samples than 1,000 to be sorted, you must restart the sort after the last selected sample.

• Page 89: Editing

  DATA REVIEW DATA BASE QUERY Ï Tags or untags a highlighted sample for batch processing. Ð Tag All Tags or untags all samples for batch processing. Ô Displays the sample result graphics screen of the highlighted sample on the Run Samples Database screen.

• Page 90: Edit A Sample

  DATA REVIEW DATA BASE QUERY Edit a Sample Select Sample Analysis tt Data Base Query. Perform a sort that includes the sample you want to edit. Highlight the patient sample to edit. Press Ë to go to the Sample Edit Results screen.

• Page 91: Batch Processing

  DATA REVIEW DATA BASE QUERY Batch Processing You can batch print in graphics format, batch transmit to a host computer, or archive a batch of sample results to a diskette. Perform only one batch process at a time. Batch Print Note: DF2 and DF3 scatterplots are not available with the print batch option.

• Page 92: To Archive

  DATA REVIEW DATA BASE QUERY To Archive Select Sample Analysis tt Data Base Query Perform a sort that includes the samples you want to archive. Use Ï or Ð to tag the samples you want to archive. Press Í Batch to display the Batch Process window.

• Page 93: To Review Archived Files

  DATA REVIEW DATA BASE QUERY IMPORTANT Do not remove the diskette from the drive until the Batch is Inactive message appears in the Batch Process window. Removing the disk sooner can cause disk corruption. 10. Wait until the Batch is Inactive message appears, then remove the diskette from the diskette drive.

• Page 94: Workload Recording

  DATA REVIEW WORKLOAD RECORDING For WBC/RBC/Plt Population: 0 = Normal 1 = Abnormal 2 = Edited For all Suspect and Definitive flags except Imm Grans/Bands: blank = no flag 1 = flag For the Imm Grans/Bands Suspect flag: blank = no flag 1 = IMM GRANS/BANDS 1 2 = IMM GRANS/BANDS 2 In the Mode of Aspiration field:..

• Page 95: Non-patient Tests Bar Graph

  DATA REVIEW WORKLOAD RECORDING Non-Patient Tests Bar Graph In the Non-Patient Test Status mode, the colors and their designations are: Dark green - CBC and CBC+Diff Control Light green - LATRON White - Calibration Red - Other tests 4-25 PN 4237519CB..
• Page 96 DATA REVIEW WORKLOAD RECORDING 4-26 PN 4237519CB..

• Page 97: Shut Down

  SHUT DOWN SHUT DOWN Shut down your HmX Hematology Analyzer for at least 30 minutes each day it is in use. Make sure the status line displays SELECT FUNCTION. Select Diluter Functions tt Shut Down. Press Ûto begin. Allow cleaning agent to remain in the instrument for a minimum of 30 minutes. Perform Start Up before running samples or controls.

• Page 98: Prolonged Shutdown Procedure

  SHUT DOWN PROLONGED SHUTDOWN PROCEDURE PROLONGED SHUTDOWN PROCEDURE If you turn off the power at night and the instrument is going to be idle for more than 48 hours, perform the following procedure. Go to the Access screen and press Ë..

• Page 99: Set Up

  SET UP CHAPTER OVERVIEW This chapter presents all of the options available in the Set Up area of the DMS software. In Heading 6.2, Control Set Up, you will find information about: CBC/DIFF file Latex file CBC file RETIC file Auto-Stop In Heading 6.3, Sample Analysis Set Up, you will find information about: Action limits..

• Page 100: Control Set Up

  SET UP CONTROL SET UP CONTROL SET UP CBC/DIFF file Select Special Functions Set Up Control set up CBC/DIFF file Select a file to set up. Insert the 5C cell control diskette into the diskette drive of the computer. Í Upload Assay Values Press Press the function key for the desired level of control.

• Page 101: Latex File

  SET UP CONTROL SET UP If the 5C cell control diskette fails to upload, you can enter all data manually. Refer to the package insert for lot specific information and assigned values. The system automatically enters the level and expected ranges based on the first two digits of the lot number.

• Page 102: Cbc File

  SET UP CONTROL SET UP CBC file Select Special Functions Set Up Control set up CBC file Select a file to set up. Manually enter data. Check that HOST: is set according to your laboratory protocol. ß toggles between ON and OFF . Verify all entries then press Ò..

• Page 103: Control Error Message Status And Action

  Review file setup. Auto-Stop ON, stops. Correct error. (CBC/DIFF only) Rerun control. Disk Drive C: Full System continues or if Bar code-labeled results lost. Call your Beckman Coulter representative. Auto-Stop ON, stops. Results without bar-code labels saved in data base. PN 4237519CB..

• Page 104: Sample Analysis Set Up

  SET UP SAMPLE ANALYSIS SET UP SAMPLE ANALYSIS SET UP Action limits Here you set the limits for XB, Definitive flags and High/Low flags according to your laboratory protocol. Enter your Laboratory Normal Ranges in the DMS if you want them to print on the report.

• Page 105: High/low Flag Limits

  SET UP SAMPLE ANALYSIS SET UP High/low flag limits Enter High/Low flag limits here. The H or L will appear next to the numeric result that exceeds the limit. Select Special Functions Set Up Sample analysis set up Action limits High/low flag limits Move the cursor to the desired field.

• Page 106: Location List

  SET UP SAMPLE ANALYSIS SET UP Location list Create a list of up to 30 location names. The maximum number of characters per name is 16. Select from this list using Ê when entering demographic Choice list data on a Worklist or when editing data in Data Base Query.

• Page 107: Display Formats

  SET UP SAMPLE ANALYSIS SET UP Display formats Here you set up your laboratory’ s choice of format for screen labels, select which parameters to display and select the reporting units you are going to use. Access to this area of the software requires the supervisor password.

• Page 108: Parameter Selection

  SET UP SAMPLE ANALYSIS SET UP Parameter Selection Select Yes for each parameter you want to display and report. Within the United States and other countries under U.S. FDA jurisdiction, PCT and PDW are For Research Use Only. Not for Use In Diagnostic Procedures.

• Page 109: Delete Database

  SET UP SAMPLE ANALYSIS SET UP Delete database The patient sample database stores the results of up to 5,000 samples. Sample 5,001 overwrites the oldest sample not marked for saving. Routine deletion of the database is not necessary. Delete the database only in special cases such as changing screen labels.

• Page 110: Clear Printer Spooler Queue

  SET UP SAMPLE ANALYSIS SET UP Clear printer spooler queue Use this feature to stop a print job and clear the DMS printer spooler of all data not yet sent to the printer. Access to this area of the software requires the supervisor password. Select Special Functions Set Up..

• Page 111: Ticket Options

  SET UP SAMPLE ANALYSIS SET UP Ticket Options Use to customize the ticket format printout. Choose from these options: PRINT UNITS Y/N If Y, the unit strings (such as % and 10^3/µL) print after the data values. PRINT NORMAL RANGES: Y/N If Y, the laboratory normal ranges section prints on the report.

• Page 112: Spooler Priority

  SET UP SAMPLE ANALYSIS SET UP To change an option: Select Special Functions Set Up Sample analysis set up Print options Ticket Options Move the cursor to an option. Use the ß to toggle between Y and N. After you have made your choices, press Ò..

• Page 113: Graphics Options

  SET UP SAMPLE ANALYSIS SET UP Graphics Options Use to customize the graphics format printout. Choose from these options: Page Format:Width/Font Use this option to select width (Narrow/Wide) and font (Small/Large). Wide width = 8.5 in. Narrow width = 4 in. When you select Narrow width, you cannot select Large font.

• Page 114: Optional Printer

  SET UP SAMPLE ANALYSIS SET UP Print Units: Yes/No If Yes, reporting units print. Print Diff Box: Yes/No If Yes, the Differential Box prints. This area allows you to handwrite manual diff results on the report. Print Normal Ranges: Yes/No If Yes, Laboratory Normal Ranges print.

• Page 115: System Set Up

  SET UP SYSTEM SET UP SYSTEM SET UP Shift You can use the same bar code-labeled lots of 5C cell control on different shifts and store them in different files. In this way, you can generate separate control statistics for each shift.

• Page 116: Reagents

  SET UP SYSTEM SET UP Reagents Use this option to record reagent information at installation or whenever you change a reagent. For the complete procedure on how to replace a reagent container, refer to the Special Procedures and Troubleshooting manual, Chapter 4. Select Special Functions tt Set Up tt System set up tt Reagents.

• Page 117: Communication Def

  SET UP SYSTEM SET UP Communication def Host Computer Definition Use this option to choose the communication format for transfer of sample information to a host computer. Refer to the Host Specifications manual for information on the transmission of data to a host computer.

• Page 118: Set Date/time

  SET UP SYSTEM SET UP Set Date/Time Use this option to: Set the date and time at installation. Change the time for a reason such as daylight savings time. Note: This is not a routine procedure. Date and time continue to update even if you turn off instrument power.
• Page 119 REFERENCES Corash L. Platelet Sizing: Techniques, Biological Significance, and Clinical Applications. Current Topics in Hematology. New York, New York: Alan R. Lise, Inc. 1983. Threatte GA, Andrados C, Ebbe S and Brecher G. Mean Platelet Volume: The Need for a Reference method.
• Page 120 REFERENCES REFERENCES-2 PN 4237519CB..
• Page 121 INDEX Symbols auto print format set up, 6-12 *R, 4-8 automatic sequencing, 3-18 *V, 4-7 autopurge cycle, 5-2 +, 4-9 auto-stop, 6-4 +++++, 3-9, 4-7, 4-9 - - - - -, 4-7 ., 4-7 : : : : : for Diff results, 4-8 B&W screen print, 1-5 ?????, 4-7, 4-9 symbol on status line, 1-6..
• Page 122 INDEX clear printer spooler queue See also latex (LATRON), 5C cell control, procedure, 6-12 Retic-C cell control clog conventions used in the manual, xii flow cell, 4-8 Ctrl+F2 keys codes function, xii listing of, 4-7 Ctrl+W keys codes and flags, 4-7 function, xii collection current XB batch, 2-25..
• Page 123 INDEX diff comparison F12 - Seq, 3-18 procedure, 2-27 FC - Full Clog, 4-8 diff scatterplots and histograms, 4-3 fitted curve, 4-2 differential comparison procedure, 2-27 5C cell control display formats, 6-9 evaluate results, 2-9 display only, 1-5 how to run when bar-code label is damaged, 2-10 software menu tree, 1-4 review or report, 2-20..
• Page 124 INDEX high/low flag limits laboratory normal ranges set up, 6-7 set up, 6-7 histograms latex (LATRON) CBC, 4-2 control run, 2-2 Plt, 4-2 review or report, 2-18 RBC, 4-2 latex (LATRON) control file VCS, 4-5 delete entire file, 2-19 host display VCS histograms, 2-18 turn auto transmission on and off, 1-5 graphs, 2-23..
• Page 125 INDEX mode-to-mode matching PLT histogram recommended quality control check, 2-24 location on run samples screen, 4-1 monitor Pop messages, Normal/Abnormal, 4-11 computer, 1-2 power monocyte population, 4-1, 4-3, 4-4 computer, button location, 1-2 MRV, 3-17, 6-10 main unit, switch location, 1-1 symbol on status line, 1-6 neutrophil population, 4-1, 4-3 definition, 4-1..
• Page 126 INDEX ready indicator light, 1-1 run samples Reagent Sensors Off message, 3-4 display, 4-1 reagents predilute mode, 3-9 expired, 2-1 primary mode, 3-4 record information in DMS, 6-18 retic mode, 3-12 screen, 4-1 background count, 2-1 secondary mode, 3-7 startup results, 2-1 run samples display, 4-1 repeat background, 2-1 run samples screen, 4-1..
• Page 127 INDEX specimen collection CBC/DIFF , 3-1 upload 5C cell control assay values, 6-2 retic, 3-12 specimen storage CBC/DIFF , 3-1 retic, 3-12 *V, 4-7 spooler priority V, 4-7 set up, 6-14 VCS histograms, 4-5 standby indicator light, 1-1 voteout Standby/Reset switch single-count period, 4-7 location, 1-1 total, 4-7..
• Page 128 INDEX INDEX-8 PN 4237519CB..
• Page 129 TRADEMARKS Beckman Coulter, the BECKMAN COULTER logo, COULTER, and 5C are trademarks of Beckman Coulter, Inc.; Beckman Coulter, COULTER, and 5C are registered in the USPTO and SIPO. All other trademarks, service marks, products, or services are trademarks or registered trademarks of their respective holders.
• Page 130 COULTER HmX Hematology Analyzer Documentation Reference Use and Function • Installation • Operation Principles • Specifications/Characteristics • Laser Safety • Reporting Options • Bar-Code PN 4237523 Specifications • Sample Tube Sizes • Diff Comparison • References • Glossary • Index Operator’s Guide..