UniCel DxH 600 Coulter Cellular Analysis System Training Modules

Transcription

1 UniCel DxH 600 Coulter Cellular Analysis System Training Modules This document is not intended to replace the information in your Instrument Instructions for Use Manual (IFU). Information in the Instructions for Use Manual supersedes information in any other manual. PN: A62452A (June 2013) Beckman Coulter Professional Development

2 UniCel DXH 600 COULTER CELLULAR ANALYSIS SYSTEM WARNINGS AND PRECAUTIONS READ ALL PRODUCT MANUALS AND CONSULT WITH BECKMAN COULTER-TRAINED PERSONNEL BEFORE ATTEMPTING TO OPERATE INSTRUMENT. BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY EQUIPMENT. INTENTION FOR USE This document is not intended to replace the information in your Instrument Instructions for Use Manual (IFU). Information in the Instructions for Use Manual supersedes information in any other manual. TRADEMARKS THE BECKMAN COULTER logo, COULTER, DxH, and UniCel are trademarks of Beckman Coulter; the BECKMAN COULTER logo COULTER, and UniCel are registered in the USPTO. All other trademarks, service marks, products or services are trademarks or registered trademarks of their respective holders. Copyright Beckman Coulter, Inc All Rights Reserved Find us on the World Wide Web at: Beckman Coulter Ireland, Inc. Mervue Business Park, Mervue Galway, Ireland Made in USA ii of iv Beckman Coulter Professional Development PN: A62452A (June 2013)

3 UniCel DXH 600 COULTER CELLULAR ANALYSIS SYSTEM REVISION STATUS Revision A (June 2013) Software release 1.0 Presented June 2013, Miami, Florida The information contained in this manual has been reviewed and approved. The materials are linked to the following references: UniCel DxH 800 Training Modules Revision A (March 2013) Software release 2.0 Presented March 2013, Miami, Florida UniCel DxH 800 Training Resources Revision A (March 2013) Software release 2.0 Presented March 2013, Miami, Florida PN: A62452A (June 2013) iii of iv Beckman Coulter Professional Development

4 UniCel DXH 600 COULTER CELLULAR ANALYSIS SYSTEM iv of iv Beckman Coulter Professional Development PN: A62452A (June 2013)

5 COURSE GUIDE System Overview Setup Troubleshooting UniCel DxH 600 System Additional Topics This document is not intended to replace the information in your Instrument Instructions for Use Manual (IFU). Information in the Instructions for Use Manual supersedes information in any other manual PN: A62452A (June 2013) 1 of 6 Beckman Coulter Professional Development

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7 TRAINING TOPICS SYSTEM OVERVIEW SETUP TROUBLESHOOTING ADDITIONAL TOPICS PN: A62452A (June 2013) 3 of 6 Beckman Coulter Professional Development

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9 GROUP DISCUSSIONS Tuesday The following discussions take place in the classroom/laboratory. Ending times noted are approximate. General Information Learn about each other Safety: Personal Protective Equipment and Fire Evacuation Introduction to the course and materials Location of additional reference materials Registration Questionnaire Instrument Demo Wednesday Thursday Friday Pro-Service Flags, Codes, & Messages PPT BCI Website Evaluations Graduation PN: A62452A (June 2013) 5 of 6 Beckman Coulter Professional Development

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11 SYSTEM OVERVIEW MODULES System Overview UniCel DxH 600 System Setup Additional Topics Troubleshooting This document is not intended to replace the information in your Instrument Instructions for Use Manual (IFU). Information in the Instructions for Use Manual supersedes information in any other manual. UniCel DxH 600 Operator Training Module PN: A62452A (June 2013) SO-1 of 60 Beckman Coulter Professional Development

12 You will see the following symbols used throughout the learning modules. Important information you should know. Techie-type information you may be interested in knowing. Do these steps now! Timely Tip You reached the goal! I do not understand Questions Resources, Help SO-2 of 60 Beckman Coulter Professional Development PN: A62452A (June 2013)

13 COURSE MAP SYSTEM OVERVIEW Begin Here System Overview Daily Checks & Shutdown Quality Control Sample Analysis Setting Up Supplies UniCel DxH 600 Operator Training Module PN: A62452A (June 2013) SO-3 of 60 Beckman Coulter Professional Development

14 Name PERSONAL PROGRESS SUMMARY System Overview Modules Date Initial Facilitator System Overview Daily Checks & Shutdown Quaity Control Sample Analysis Setting Up Supplies SO-4 of 60 Beckman Coulter Professional Development PN: A62452A (June 2013)

15 OBJECTIVES SYSTEM OVERVIEW Given an operating DxH 600 System: Log On and Log Off the System Manager Identify the main hardware of the system by labeling a diagram Locate and identify the areas and icons used on the screen by labeling a diagram State the meaning of icon colors and how to respond to them Access System HELP using the Help icon Find information using the Contents, Index and Search features Use hypertext jumps within Help Print Help topics Create Favorites in Help Why Is It Important? This module introduces the basics of the DxH 600 System. A basic hardware overview allows identification of the general parts of the system. A basic software introduction shows how to log on to the System Manager and identifies the main screen areas and icons and their names using basic Windows software conventions. The introduction to System HELP shows you how to access the information contained in the Instructions for Use. These topics form the building blocks for the rest of your learning journey. Resources DxH 600 System DxH 600 HELP UniCel DxH 600 Operator Training Module PN: A62452A (June 2013) SO-5 of 60 Beckman Coulter Professional Development

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17 INFORMATION/PRACTICE Logoff/Logon to the System Manager In order to access the System Manager, you must Log on. Both an Operator ID and a Password are required. The system administrator will assign these to you in the lab. For ease of use in the customer classroom, use BCI as the Operator ID and bci (lower case) as the Password. Both the Operator ID and Password are case-sensitive. Step Action 1 Select the Logoff icon at the top right of the screen. 2 On the Logoff screen, select the logoff button. 3 On the Logon screen, type in the user name: BCI (case sensitive), press tab. 4 Type in the Password: bci (case sensitive). Note If you forget your password, contact your laboratory administrator to have your password reset. 5 Select the Log On button or Press Enter. You will now be on the DxH Solutions home screen. Once you select any button or icon to move to a different screen, the home screen disappears. You will only see it after a Log On or if you press the F8 key. NOTE: Neither the Operator ID nor the password bci is present in the system. Upon installation, Operator IDs and Passwords must be set up. System Manager Statistics Your System Manager (computer) consists of the following: Computer with CD/DVD RW drive running Microsoft Windows XP Professional operating system LCD flat panel monitor, touch screen DxH Solutions Software Optical USB mouse Standard keyboard UniCel DxH 600 Operator Training Module PN: A62452A (June 2013) SO-7 of 60 Beckman Coulter Professional Development

18 Access System HELP All graphics including screens and printouts are for illustration purposes only and must not be used for any other purpose. Step Action 1 Select the System HELP icon. 2 Select the Index tab on the left side of Help. 3 Type the words home screen in the keyword field A list displays, double click on the words home screen in the list or select the words and select the Display button at the bottom. Take some time to study the Home Screen figures to learn the names of the areas on this screen. You will label a diagram with the correct names as part of the skill check later. To place this in Favorites as a reference for you, select the Favorites tab (to the right of the Index tab). 7 Then, select the Add button near the bottom. 8 You may now refer to this topic any time you select Favorites. 9 To delete a topic from Favorites, highlight it and select Remove The Help screen may be moved and resized to place it in a better position on the screen while you are working. Try it now! The font icon at the top of the Help screen allows you to increase or decrease the size of the font used to make it easier for you to read. Try it now! The print icon at the top of Help allows you to print any information that you want from Help. It will print in the font size chosen. Please feel free to print any topics that you want this week. 13 To close Help, select x. SO-8 of 60 Beckman Coulter Professional Development PN: A62452A (June 2013)

19 Software Overview System Status, Worklist, Daily Checks, Quality Control, XB/XM, Supplies, Event Log The meaning of the alert status icon colors are: Red = error, Yellow = warning, Neutral = OK. To review the software areas, select the Help icon, Contents, expand Chapter 1, expand System Manager Indicators and view the different areas within the home screen. The software application module provides you with the following data storage capabilities for the DxH 600: 40,000 patient results with graphics per module 12,000 CBC/Diff/Retic/NRBC raw data files 30 control files, each with a maximum of 150 runs UniCel DxH 600 Operator Training Module PN: A62452A (June 2013) SO-9 of 60 Beckman Coulter Professional Development

20 Hardware Overview The DxH 600 is available as an analyzer for use on a tabletop only. The DxH 600 System includes a Specimen Processing Module (SPM), a Pneumatic Supply Module (PSM) and a System Manager, precisely integrated to provide process control, data consolidation, and cassette or single-tube delivery of specimens. System HELP can provide a quick overview: Step Action 1 Select the Help icon. 2 Select the Contents tab. 3 Find Chapter 1 System Overview, and then select the tree. to expand 4 Expand Hardware, select Front View of the SPM. 5 Take some time to study the figure, Front View of SPM. You will label a diagram with the correct names as part of the skill check at the end of this module. 6 Place this info into your Favorites. Note The two Beacon colors are Red (Cannot Run) or Green (OK to Run). Congratulations, you have finished Basics! Continue to the Skill Check. SO-10 of 60 Beckman Coulter Professional Development PN: A62452A (June 2013)

21 SYSTEM OVERVIEW SKILL CHECK 1. Label the sections of the Home screen: Label the main areas of the DxH System: UniCel DxH 600 Operator Training Module PN: A62452A (June 2013) SO-11 of 60 Beckman Coulter Professional Development

22 1 3. Label the parts of the SPM: Show facilitator your favorites tab. Demonstrate how to add and remove a topic. 5. Show facilitator how to Log off and Log on. 6. List the Supplies used in the DxH 600 System: What do the colors mean? SO-12 of 60 Beckman Coulter Professional Development PN: A62452A (June 2013)

23 OBJECTIVES DAILY CHECKS & SHUTDOWN Given an operational DxH 600 System and using the System HELP: Point to the last time a Daily Checks or Shutdown was run using the DxH 600 Status screen Access the Daily Checks Summary Screen Request a Daily Checks cycle Set up automatic Daily Checks Review the Daily Checks results Add a comment to Daily Checks results Set up printing options of the Daily Checks results Access the Export Daily Checks (optional) Perform the Shutdown procedure using DxH Cleaner State the minimum time the instrument should be in Shutdown and how often Shutdown should be performed Set up Enable Automatic Shutdown to occur from Monday thru Friday at 5:30. Why Is It Important? The Daily Checks screen shows you the results of running the Daily Checks diagnostic tests. The summary screen gives a quick overview of the results and any alerts due to failed tests. The Shutdown procedure must be performed every day that the instrument is used. Shutdown is used to ensure optimal cleaning of the instrument. Resources DxH 600 System Blank CD UniCel DxH 600 Operator Training Module PN: A62452A (June 2013) SO-13 of 60 Beckman Coulter Professional Development

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25 INFORMATION/PRACTICE Daily Checks Daily Checks ensure that your DxH 600 System is running correctly. Daily Checks may be scheduled to occur automatically or manually when initiated at the System Manager. Run Daily Checks Step 1 Action Select the System Status icon. Double click on the instrument silhouette or click on the Details Status button on the Local Navigation Bar (bottom of screen). Look at the DxH 600 Status screen to give you an overview of basic information about the instrument. 2 Note the date and time of the last Daily Checks, Shutdown, Last Control (run) and Calibration. If the date and time are a neutral color, all is OK. If they are red, there is a problem. 3 Look at the sphere next to Operation. A green sphere means OK. A red sphere means a problem. A gray sphere means disabled. A black sphere means disconnected. UniCel DxH 600 Operator Training Module PN: A62452A (June 2013) SO-15 of 60 Beckman Coulter Professional Development

26 Select the Daily Checks button to display the Daily Checks Summary screen with results of the most recent Daily Checks Select the Daily Checks button at the local navigation bar (bottom of the screen). A DxH Solutions dialog box displays the following: You have requested to perform Daily Checks. Select OK to run Daily Checks, or Select Cancel. For classroom practice, Perform a Daily Checks now. While this cycle is running (approx. 4.5 minutes), refer to the Run Daily Checks Help topic in Chapter 3. SO-16 of 60 Beckman Coulter Professional Development PN: A62452A (June 2013)

27 Reviewing Daily Checks Step Action Look at the Daily Checks icon. Note - When Daily Checks pass,, icon is neutral. - If any of the Daily Checks do not pass, the; icon is red. Problematic result is backlit in red on the Summary tab. Tab that contains the problematic result has a red indicator. 1 Look at each Daily Checks tab, beginning with the Summary tab. 2 Select the individual tabs to view those results. If there are any failures, you must select Review in order to proceed with further analysis. 3 If any Background result fails, run Daily Checks again Note Verify your background results when the Daily Checks cycle finishes. For classroom practice, use View Log to find a Daily Checks with a Fail entry, select it and then select the Details button. Select the Review button. A dialogue window appears asking: Are you sure you want to acknowledge the Daily Checks failure? Press OK to continue. When you click Review for failed results, you are acknowledging the failure and the need to repeat the Daily checks. Be sure to document per your regulatory requirements. You could add a comment in the History Log. If Daily Checks pass, the Review button is disabled. You only have to review results that are questionable. 7 Select OK. UniCel DxH 600 Operator Training Module PN: A62452A (June 2013) SO-17 of 60 Beckman Coulter Professional Development

28 Daily Checks Auto Configuration Step Action From the Daily Checks screen, select Auto Configuration > Configure Daily Checks to display the Auto Daily Checks Configuration dialog box Select Enable Automatic Daily Checks to enable running daily checks automatically on your system. You have 2 options to choose from: Perform Daily Checks After Shutdown Perform Daily Checks at a Specified Time For classroom purposes, select Perform Daily Checks at a specified time. Hour will be 6, Min will be 30, and check the Daily check box. If you select to Perform Daily Checks After Shutdown, select OK to save OR If you select Perform Daily Checks at a Specified Time, select a time and day, and select OK to save. SO-18 of 60 Beckman Coulter Professional Development PN: A62452A (June 2013)

29 Viewing Past Results/Adding Comments Step Action 1 Select the View Log button from the Local Navigation Bar. You may select one date at a time to review Note: You may view the Daily Checks entries and any areas that failed within that Daily Checks will be backlit in red and have a Fail. Once highlighted in blue, select the Details button below to view all tabs of those results. Select View Log to return to the log or the back arrow on the upper left of the screen to go back one screen. Select a date now. With any date highlighted, select the Comments button below to add a comment. Do this now! 5 Select OK to save comment. 6 7 Once saved, you will see a yellow, page icon appear to let you know there is a comment associated with that entry. You may go back to a comment to edit it as well. Note: Comments added to the Daily Checks Data Summary Log can be printed or exported. The comments currently do not appear on the printout: however, the comments are contained in the export file. Be sure to save at least one comment for any Daily Checks result as part of this exercise. Print/Export Daily Checks Step 1 2 Action Select at the top of the Daily Checks screen to manually print Daily Checks Summary (one page) or Detail Reports (three pages). If you select View Logs from the Daily Checks screen, it will take you to History Logs >Data Summary Logs, where you may print: Entire Log, All Filtered, or Selected Entries. UniCel DxH 600 Operator Training Module PN: A62452A (June 2013) SO-19 of 60 Beckman Coulter Professional Development

30 3 4 5 Print two selections from the log, including today s results and one from a week ago. You may also export the Daily Checks results. The Export button on the local navigation bar exports Daily Checks results to a raw data file (INF/DAT) or a.csv file. The.csv file may be opened by a spreadsheet program. This is an optional exercise. Follow the steps and save a week worth of Daily Checks onto a CD. Auto Report Daily Checks Step 1 Action Select at the top of any screen to display the Daily Checks screen for the module selected on the System Status Screen. Select Auto Report to display the Daily Checks Auto Report dialog box. 2 3 You may decide to have the Daily Checks print automatically. 4 5 You may select to print automatically either the Summary report or the Details report, or both. For classroom practice, choose Enable auto Summary Report Generation and select OK. SO-20 of 60 Beckman Coulter Professional Development PN: A62452A (June 2013)

31 SHUTDOWN The DxH 600 System allows you to program the length of time the instrument is in Shutdown. Read the Shutdown HELP topic in Chapter 8 for reference. If the instrument exceeds 24 hours without having a shutdown performed, the DxH 600 System Status (Details Status Screen) will have Date/Time Shutdown box backlit in yellow. This serves as an alarm to the operator. No additional system messages will appear in the History Log. At the end of the shutdown programmed time, the system removes DxH Cleaner and replaces it with DxH Diluent. It then awaits a Daily Checks cycle, performed manually or automatically. If a Shutdown cycle needs to be interrupted, just cancel and then request a Daily Checks cycle. Step Action From the Daily Checks screen, select the Shutdown button to display the Manual Shutdown dialog box. 1 Once you select OK, no other cycles or System Manager actions can be performed until the Shutdown cycle has completed. Note: Once the Shutdown cycle is complete, a countdown timer bar appears near the bottom of the Daily checks screen to let you know how much time remains for the cleaning. 2 Select the Perform Startup After Shutdown check box to automatically begin Daily Checks after Shutdown. UniCel DxH 600 Operator Training Module PN: A62452A (June 2013) SO-21 of 60 Beckman Coulter Professional Development

32 3 4 Enter the number in the Time in Cleaner Hours and Minutes text boxes to determine the time in cleaner. The default time in cleaner is 30 minutes. The maximum time in cleaner is 24 hours. Select OK to begin shutdown or Cancel to exit the pop-up window without starting shutdown. UNLESS YOUR FACILITATOR SAYS TO DO SO, DO NOT PUT THE INSTRUMENT INTO SHUTDOWN AS IT IS PROGRAMMED TO GO INTO AUTO SHUTDOWN AT THE END OF THE DAY. Enable Automatic Shutdown The DxH 600 System allows you to configure the Auto Shutdown Cycle. Read the Daily Checks Configuration HELP topic in Chapter 9 for reference. Step Action From the Daily Checks screen, select Auto Configuration>Configure Shutdown to display the Auto Shutdown Configuration dialog box. 1 2 Select Enable Automatic Shutdown to enable running Shutdown automatically on your system. Follow the steps to enable/configure automatic Shutdown cycles. 3 Type in one hour for time in cleaner. 4 Type in 5:00 for the time the cycle should begin and select Monday through Friday. 5 Select OK to save your selections. Please continue to the Skill Check on the next page. SO-22 of 60 Beckman Coulter Professional Development PN: A62452A (June 2013)

33 DAILY CHECKS & SHUTDOWN SKILL CHECK 1. Show your printouts from the exercise that includes today s result and one from a week ago to the facilitator. 2. Go to the System Status screen and point to the time of the last Daily Checks cycle. 3. Show facilitator that you set up automatic Daily Checks using Auto Configuration. 4. Show facilitator the comment you added to a Daily Checks results. 5. Show facilitator that you set up automatic printing of Daily Checks. 6. Show facilitator the steps to Export Daily Checks results. (optional) 7. What is the minimum time for the DxH 600 System to be in shutdown? 8. How often should a Shutdown cycle be performed? 9. What step would you take if shutdown is programmed for one hour and you get a STAT after only 15 minutes has elapsed? UniCel DxH 600 Operator Training Module PN: A62452A (June 2013) SO-23 of 60 Beckman Coulter Professional Development

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35 OBJECTIVES QUALITY CONTROL Given an operating DxH 600 System, access to the System HELP and package inserts from control products: Describe proper storage and handling for COULTER LATRON CP-X Control Describe proper storage and handling for COULTER 6C Cell Control Describe proper storage and handling for COULTER Retic-X Cell Control Describe proper storage and handling for COULTER Body Fluid Control Use the System Help for procedures to run the various controls Process the various controls Access the control data (results), select various controls Review control results: data and graphs Recognize flagged results Add a comment to a control run Exclude a control run from statistics Why Is It Important? Understanding how to store, handle and use the control products available ensures reporting out the most accurate results possible to the clinician. Resources DxH 600 System Control package inserts for Latron CP-X control, 6C, Retic-X and Body Fluid cell controls. Control products for processing UniCel DxH 600 Operator Training Module PN: A62452A (June 2013) SO-25 of 60 Beckman Coulter Professional Development

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37 INFORMATION/PRACTICE Control Storage and Handling Obtain the product insert sheets for each control and answer these questions on proper storage and handling: COULTER LATRON CP-X Control Latron CP-X Control may be stored at room (ambient) temperature or refrigerated temperature. True or False Latron CP-X Control must be at room temperature before use. True or False Gently mix a room temperature tube of Latron CP-X Control by five to eight times. Avoid foaming. COULTER 6C Cell Control Store refrigerated at ºC After warming at ambient (16-30 ºC) temperature for minutes, mix each tube individually by hand using the 8x8x8 method, times. Run the controls in any order using Cassette Presentation and return to the refrigerator within minutes. COULTER Retic-X Cell Control (Optional) Store refrigerated at ºC After warming at ambient (16-30 ºC) temperature for 15 minutes, mix each tube individually by hand using the 8x8x8 method, time. Only repeat if necessary after inspecting the tube for complete resuspension. Run the controls in any order using Cassette Presentation and return to the refrigerator within minutes. COULTER Body Fluid Cell Control (Optional) Store refrigerated at ºC After warming at ambient (16-30 ºC) temperature for minutes, mix each tube individually by hand using the 8x8x8 method, times. Run the control using the Single Tube Presentation, in consecutive order beginning with Level and ending with Level. Return to the refrigerator within minutes. UniCel DxH 600 Operator Training Module PN: A62452A (June 2013) SO-27 of 60 Beckman Coulter Professional Development

38 Analyzing Commercial Controls Step 1 2 Action Ask your facilitator to provide you with a set of package inserts for all controls. You will also need the controls to run on your instrument. Please run all controls, all levels. Prepare the controls according to the instructions on the package insert. 3 Select the Start button instrument on-line. from the upper right to put the 4 Run the controls according to the instructions on the package insert. Viewing/Reviewing Control Results Step Action Note: Read Chapter 4 Quality Control to familiarize yourself with the various QC screens. 1 Select the Quality Control status icon. Under QC out conditions, the Quality Control status icon at the top of the screen is red. If more then one lot is out, a dialog box is displayed. 2 If you want to review a different control or level, use the Select Control button from the local navigation bar. This opens a control tree that you may expand to choose the various controls and levels for review. Control files also have filters that let you select a Control State. These filters are as follows: Accumulating, Active and Inactive. We will go over this in the Setup>Control Files Module. 3 Highlight the control you wish to view and select OK. SO-28 of 60 Beckman Coulter Professional Development PN: A62452A (June 2013)

39 Find Summary Data (statistics) on the left of the screen. Find the results of the most recent run to the right, the column highlighted blue. Values that are outside of the expected range are in red. At the bottom of the column, you will see the word Exclude. If you select this checkbox, the run will not be included in the statistics. If you deselect the checkbox, it will be included again. 4 Select the View Graph button bar. from the local navigation This allows review of the Levey-Jennings graphs. The smaller graphs are thumbnails that present the most recent ten runs. The larger (expanded) graph shows all runs for a parameter. As you select each parameter thumbnail, the expanded graph changes to that parameter. Various symbols and colors represent whether a data point is within range, outside 2SD, outside 3SD or excluded. 5 Return to the data screen by selecting the View Data button. 6 Note that there is another thumbnail graph on the left. This changes when you highlight another parameter on this screen. 7 Select the Comment button bar. from the local navigation This opens a window that allows you to add a comment to a control run. You may add to or edit comments after saving them. 8 Add a comment to one of your control runs from today. 9 Select the Click to Review at the bottom of an unreviewed control run. The system will prompt you: Do you want to review this run? Click OK. This will show that the control run was reviewed. Do this for all your control runs for this exercise. In your lab, follow your laboratory s protocol. UniCel DxH 600 Operator Training Module PN: A62452A (June 2013) SO-29 of 60 Beckman Coulter Professional Development

40 Printing Control Data Manually print individual runs using the Print button in the utility area. For Auto-Print, go to Menu/Setup/QC/Edit Control. You may enable/disable Auto Print for each control file to set up automatic printing. Please continue to the Skill Check on the next page. SO-30 of 60 Beckman Coulter Professional Development PN: A62452A (June 2013)

41 QUALITY CONTROL SKILL CHECK 1. Have facilitator check the answers on page SO Show how to select different control files. 3. Show facilitator your QC runs in the System Manager. Be sure they are all marked as reviewed. 4. Point out which control was run in single-tube presentation 5. Show the comment you added, on the screen and on a printout. 6. Point out a value that is out of range. 7. Show the excluded run, on the screen and on a printout. UniCel DxH 600 Operator Training Module PN: A62452A (June 2013) SO-31 of 60 Beckman Coulter Professional Development

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43 OBJECTIVES SAMPLE ANALYSIS Given an operating DxH 600 System, access to System HELP and blood specimens collected in EDTA anticoagulant: State the aspiration volume for sampling Identify the five types of cassettes (A, A+,B, C, D) and the tubes to use in each Set Up Specimen Warnings Process bar coded samples using cassette presentation Process bar coded samples using single-tube presentation Adding a Test Order Manually Process body fluid specimen (optional) Process a STAT Dispense diluent Process a prediluted sample Process a specimen in a microtainer using single-tube presentation (optional) Rerun a sample Reflex a test to a previously run sample Data Review and Partial Release Why Is It Important? The DxH 600 System is a quantitative, multi-parameter, automated hematology analyzer for in vitro diagnostic used in screening patient populations found in clinical laboratories. Running samples is a daily task that occupies much of your time in the lab. Learning how to process samples efficiently on the DxH 600 System saves you time. Resources DxH 600 System Blood specimens collected in EDTA Bar code labels Cassettes Pipettors, tips, microtainers and clean tubes UniCel DxH 600 Operator Training Module PN: A62452A (June 2013) SO-33 of 60 Beckman Coulter Professional Development

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45 INFORMATION/PRACTICE Cassette Types and Tubes * Tube height minimum is measured from the bottom of the tube to under the cap; the maximum is measured including the cap. Short pierce depth tubes include: Long false bottom tubes which fit into the Type B cassette. Smaller length tubes such as 2 and 3 ml pediatric sizes, or tubes shorter than a Beckman Coulter control product tube, which fit into the Type D cassette. Specimen Information Whole Blood: Notes 1 Collect whole blood in EDTA according to tube manufacturer s instructions and procedures in: CLSI publication H04-A6 (for capillary) CLSI publication H03-A6 (for venipuncture) Beckman Coulter recommends using K 2 or K 3 EDTA. Body Fluids: 2 To reduce body fluid sample viscosity, use hyaluronidase to treat synovial fluids prior to analysis according to your laboratory standards. Adding the ratio of 1 ml of synovial fluid to 5 mg of hyaluronidase. Mix for 5 minutes. UniCel DxH 600 Operator Training Module PN: A62452A (June 2013) SO-35 of 60 Beckman Coulter Professional Development

46 Aspiration: DxH System aspiration volume is 165 µl. 3 Pre-diluted blood CBC analysis requires a dilution of 50 µl of blood and 200 µl of diluent for a x5 dilution. Tube dead volume varies depending on the tube s physicial charactertistics (length, diameter), tube bottom adjustments and the sampling presentation. The least dead volume is required by the spring-loaded side of the Single-Tube presentation station. Sample Stability and Storage: Important: Refer to CLSI H18-A4, Procedures for the Handling and Processing of Blood Specimens. Whole Blood: Long term stability is determined by comparing results from the initial analysis (within two hours of collection) to results from samples stored at controlled room temperature for 24 hours and refrigerated temperature for 48 hours. Upon removal from refrigerated storage, samples were hand mixed by inversion 20 times, allowed to warm at room temperature for a minimum of 30 minutes and then mixed by inversion 20 times prior to analysis. 4 At Room Temp. At Refrig. Temp. CBC 24 hours 48 hours NRBC 24 hours 24 hours Retic % 24 hours 72 hours Body Fluids 1 hour Not Applicable Body Fluids: Per established literature, Body Fluids samples should be stored at room temperature and analyzed within 1 hour of collection. SO-36 of 60 Beckman Coulter Professional Development PN: A62452A (June 2013)

47 Specimen Warnings You may set up warnings in the DxH 600 System that alert you when more time has elapsed then expected for a STAT to begin analysis and/or for result release. Step Action Select Menu > Setup > System > More > Specimen Warnings to display the Specimen Elapsed Time Warnings. 1 There are two options: STAT specimen time to analysis - STAT analysis has not been initiated due to the elapsed minutes since the specimen receipt or collection (as noted on the test order). STAT specimen time to release - STAT results are not released due to the elapsed minutes since the first or last result completion, or the 2 For classroom practice do the following: Check the STAT specimen time to analysis>warn after check box and type in 2 minutes. For the Initiating event field choose Date/time of specimen receipt. Check the STAT specimen time to release>warn after check box and type in 2 minutes. For the Initiating event field choose Date/time of first result complete. UniCel DxH 600 Operator Training Module PN: A62452A (June 2013) SO-37 of 60 Beckman Coulter Professional Development

48 3 Select OK. When the warning is triggered: Note The Worklist Icon will backlight in yellow. An audible alarm will be going off. And, the Worklist icon will flash between the tube and bell graphic. You will see how this works later on in this module. Cassette Presentation Obtain specimens and barcode labels from your facilitator. This section assumes bidirectional LIS download and positive identifier set to Specimen ID. Step Action 1 Ensure the SPM is online. 2 Ensure your specimens have been collected, stored, and handled properly. Load the specimens into the cassettes. 3 Place the cassettes into the input buffer. The SPM automatically begins cycling the cassettes. 4 5 After the SPM cycles the samples, review the sample results at the System Manager. SO-38 of 60 Beckman Coulter Professional Development PN: A62452A (June 2013)

49 Single-Tube Presentation The Single-Tube Station accepts many sizes of tubes. A fixed bar code reader reads labels at or near the depression on the cover. Each side of the cradle has a mechanical switch for tube recognition. The right (green) position is designed for open vial aspiration from 7 to 13 mm diameter tubes. The open vial position uses a spring-drive adjustment to allow aspiration from tubes with minimal dead volume. The minimum tube height is 28mm. The maximum tube height is 107 mm. The left (lavender) position adapts to both open and closed vial tubes from 10.5 to 13 mm in diameter. The minimum tube height is 55 mm (measured from under the cap). The maximum tube height is 107 mm (with cap, if present). Obtain another bar-coded specimen. Step Action 1 Obtain another bar-coded specimen. Select the Single-tube Presentation icon. The single-tube Presentation Dialog Box will come up. 2 UniCel DxH 600 Operator Training Module PN: A62452A (June 2013) SO-39 of 60 Beckman Coulter Professional Development

50 3 Place the specimen on the bar-code reader platform of the Single-tube Presentation Station with the bar code facing the SPM to allow the Single-Tube Presentation Bar Code Reader to scan the specimen label. You may also type or scan the specimen identifier. You need to place the curser at the end of the last character of the Specimen ID and press enter. Note 4 Verify the Specimen Identifier and Test request. Follow the prompts on the screen. 5 Mix the specimen according to your laboratory standards. 6 Place the specimen into the correct Single-tube position. Note To process a sample collected in a micro-collection device, use single-tube presentation and place the tube on the right-hand side of the cradle. Predilute Step Action The predilute function is a fixed x5 dilution. Obtain diluent from the instrument, using the Diluent Dispense, to use in making a dilution of a previously run sample. You will need an empty tube to obtain the diluent. Follow the steps below. 1 Select the Single-tube Presentation icon. Select the Diluent Dispense button. 2 SO-40 of 60 Beckman Coulter Professional Development PN: A62452A (June 2013)

51 3 Follow the directions on the screen, using an empty tube. 4 Prepare your x5 dilution. (Example: 50uL of sample and 200uL of diluent). 5 If SPM timed out, select the Single-tube Presentation icon. Scenario for Running a Pre-diluted Sample 1. Scan, Barcode, or Type the Specimen 2. The Dialog Box comes up Test Order not Identifier and press Enter. Found for specimen identifier XXXX, Default Test order assigned. Select OK. 3. Highlight the Selected Panel and click 4. Press the Submit button. Remove. Then, select the Available Panel PREDIx5 and click Add. 6 Place the specimen into the correct Single-tube position. 7 Once the sample is aspirated and the tube is returned select to finish. UniCel DxH 600 Operator Training Module PN: A62452A (June 2013) SO-41 of 60 Beckman Coulter Professional Development

52 Adding a Test Order (Manual Entry) You can add a test order by automatically downloading the order from the LIS or by manual entry. Note: Batching must be disabled in order to manually add a test order. If Add Order is disabled, batching is enabled. See Batching in Chapter 9, Setup for additional reference. Step 1 Action Select Menu>Worklist>Pending tab or click the Worklist icon and then the Pending tab. From the Worklist Pending tab screen, select Add Order to display the Add Order Screen. 2 3 Press (Tab) to move through each section and follow the steps for Specimen Information, Available Panels, and Patient Information. For classroom practice, get a downtime barcode label and enter the following sample information manually. Specimen ID: scan the barcode label Specimen Type: Whole Blood Specimen Priority: STAT Draw Date: today s date Selected Panel: CD Patient ID: Type in Today s Date (example: ) (When you type in the Patient ID and click Enter, you will get a box to find the patient. Click on Add Patient.) Type in the Patient ID: Type in Today s Date Last Name: Transformer First Name: Nicholas In your lab, you may add additional Demographic information in the active fields provided. SO-42 of 60 Beckman Coulter Professional Development PN: A62452A (June 2013)

53 4 Click OK. 5 Click Submit. For classroom practice, wait 2 minutes before running this sample and you will see the specimen warning signal flashing and alarming since this specimen is a STAT. 6 7 You will see: The Worklist Icon will backlight in yellow. An audible alarm will be going off. And, the Worklist icon will flash between the tube and bell graphic. Place the sample on a cassette and run it in cassette presentation or you may run it in single-tube presentation. Data Review and Partial Release Once samples finish processing they move from the Pending tab to the Not Processed, Review or Released tab. You can choose to release automatically all samples to the LIS (most labs), you may choose to partially release portions of the test panel (ie: WBC, RBC, PLT, Diff, Retics), or you can review the results from the System Manager. The Pending Tab displays all patient test orders with a pending or partially complete result status (any result status that is not complete). The Not Processed Tab on the Worklist displays exceptions for specimens that have been skipped such as No Read or No Match. You may need to address the problem and reload the skipped specimens for processing. When exceptions are posted to the Not Processed tab, is red. This tab view is automatically displayed when you select the worklist icon. The Review Tab displays specimens that have been held (not released) and require attention. The Released Tab displays the released results according to the filter that you select. UniCel DxH 600 Operator Training Module PN: A62452A (June 2013) SO-43 of 60 Beckman Coulter Professional Development

54 Step 1 Action Now that you ve run samples in different modes, go to the Worklist>Review Tab. When you open the Review Tab, all the results that are pending review or release will appear in this list. Note: This is dependent on your Laboratory s release criteria. 2 Select a sample from the list and click on Details. The Patient Results screen will display showing the results and graphics. You can Rerun/Reflex, Partial Release, or Release Run. If a sample requires a rerun you can order it, or you may use the Decision Rules to automatically rerun or reflex. 3 Select the Partial Release Navigation Bar. button from the Local 4 Select the WBC and PLT for Partial Release. You may: Release the entire run by checking all the group boxes individually or selecting the checkbox on the top of the run. Release groups from multiple runs. SO-44 of 60 Beckman Coulter Professional Development PN: A62452A (June 2013)

55 The test groups selected will be shown in the far right column labeled Release. Results are shown in brackets until released using the Release Selected button. You can select the following groups: CBC WBC which includes WBC, UWBC CBC RBC which includes RBC, Hgb, HCT, MCV, MCH, MCHC, RDW, RDW-SD CBC PLT which includes PLT, MPV DIFF which includes % and #s RETIC which includes %, #, MRV, IRF If DIFF is partial released without a WBC subpanel, differential absolute results are inhibited. If RETIC is partial released without an RBC subpanel, the RETIC absolute results are inhibited. WBC, RBC, or PLT subgroups must be released from the same CBC group. You can mix CBC, DIFF and RETIC groups from up to three different runs. You cannot edit results that have been selected for partial release (even if those results have not been final released). Only R flags associated with a System message are retained when recalculated results are merged in the release process. All System messages from all associated runs are retained. Selecting Unselect Tests clears selections that are not released. Select Release Selected. A DxH dialog box displays the following: Are you sure you want to release these results? Select Yes to release the results 5 UniCel DxH 600 Operator Training Module PN: A62452A (June 2013) SO-45 of 60 Beckman Coulter Professional Development

56 i e w. Once the Results are Released, the final report is displayed in Patient Results under the Merged Tab. R e r u n W h e n y o u 6 r For additional information, review the information in Help, Chapter 6 Data Review. Rerun When you review a result from the Review tab, you may choose to rerun the specimen. Choose the Rerun/Reflex button, and then choose Rerun. If the specimen has just been processed recently and the cassette has not ejected to the output buffer, the instrument will automatically rerun the sample chosen. Otherwise, find the sample and place it back in the input buffer. Once you place this request, you will notice on the Details screen that a column called Run 2 appears. You will be able to see both runs side by side. You may then choose which result to release. Reflex You may use this feature to add a test to a specimen already processed. If the original only had a CBC ordered, you may use this to add a Diff and/or a Retic. Choose the Rerun/Reflex button, and then choose Reflex. A screen will appear to allow you to add the additional test(s). SO-46 of 60 Beckman Coulter Professional Development PN: A62452A (June 2013)

57 If the specimen has just been processed recently and the cassette has not ejected to the output buffer, the instrument will automatically run the sample chosen. Otherwise, find the sample and place it back in the input buffer. Note: When using Decision Rules (a later module), the Rerun/Reflex functions can be automated based on the rule. Edit/Amend Patient Results Edit is an option on the Review tab that lets you edit patient results before release. Results that cannot be edited on the Edit Patient Results dialog box are grayed out. Edited results are flagged with and E. Results calculated from edited results are flagged e. Note: The option to edit is not available for released results. The option to Amend is available for released results. Step Action Editing an Order in the Pending Tab 1 Select Menu>Worklist>Pending tab or click the Worklist icon and then the Pending tab. 2 Select any sample from the list and select Edit Order. 3 You may edit any field that is active (white background). For classroom practice, edit the Specimen Priority to ASAP. When a Patient demographic is associated with the test order, a Patient button is enabled from the local navigation bar on the Add Order and Edit Order screens which lets you select from the following options: Clear Patient: Lets you disassociate the currently selected patient from the Test Order. In other words, it clears the patient demographic. Edit Patient: Displays the Edit Patient Demographics Dialog. Lets you edit all of the patient demographics with the exception of the Patient ID. Rectify Patient ID: Lets you enter the correct patient ID (in case the patient ID is wrong). See Rectifying Patient ID in CHAPTER 9, Setup for additional information. UniCel DxH 600 Operator Training Module PN: A62452A (June 2013) SO-47 of 60 Beckman Coulter Professional Development

58 4 Edit the patient name to Last Name: Koko, First Name: Jim 5 Click OK and Submit. You will see the changes made on the Pending List. Editing an Order in the Review Tab 1 Select Menu>Worklist>Review tab or click the Worklist icon and then the Review tab. 2 Select any sample from the list and select Edit Order. 3 You may only edit the fields that are active (white background). For classroom practice, edit the Specimen Priority to Pre-Op. When a Patient demographic is associated with the test order, a Patient button is enabled from the local navigation bar on the Add Order and Edit Order screens which lets you select from the following options: Clear Patient: Lets you disassociate the currently selected patient from the Test Order. In other words, it clears the patient demographic. Edit Patient: Displays the Edit Patient Demographics Dialog. Lets you edit all of the patient demographics with the exception of the Patient ID. Rectify Patient ID: Lets you enter the correct patient ID (in case the patient ID is wrong). See Rectifying Patient ID in CHAPTER 9, Setup for additional information. Same as Editing an Order in the Pending Tab. Editing an Order in the Released Tab 1 Select Menu>Worklist>Released tab or click the Worklist icon and then the Released tab. 2 Select any sample from the list and select Edit Order. SO-48 of 60 Beckman Coulter Professional Development PN: A62452A (June 2013)

59 Step Action Amend Patient Results Amend is an option on the Released tab that lets you edit released results. The Specimen ID cannot be edited. 1 For classroom practice, select the Release Tab and select a result that has been released. 2 Click on at the bottom of the screen. 3 4 You will be on the Patient Results Screen with the Released results. Click on at the bottom of the screen. The system allows you to change the WBC, RBC, HGB, HCT, MCV, and PLT results. Change the Hgb result to Instead of an E, an M is displayed in the first position after an amended result. Results calculated from amended results are flagged m. Limits sets are re-evaluated when results are amended. Decision rules are not re-evaluated. Viewing Dataplots and Histograms The Details screen shows numeric results, histograms, dataplots and messages. For a larger view of the histograms, double-click on them. All three enlarge together. The 2-D dataplots for 5PD1 (Diff), NRBC1 and RETIC1 each have a separate tab. For a larger view, select the View All VCSn Graphics button. This provides larger views of the three measurements in 2-D (including 5PD2, NRBC2 and RETIC2), 3-D and Surface Plot graphics. UniCel DxH 600 Operator Training Module PN: A62452A (June 2013) SO-49 of 60 Beckman Coulter Professional Development

60 Body Fluids (Optional) To reduce body fluid sample viscosity, use hyaluronidase to treat synovial fluids prior to analysis according to your laboratory standards. Add in the ratio of 1 ml of synovial fluid to 5 mg of hyaluronidase. Mix for 5 minutes. Note: Beckman Coulter recommends that a diluent be run as a Body Fluid sample prior to analysis of Body Fluid specimens to verify acceptable backgrounds. The Body Fluid mode provides extra cleanup after running this type of sample. Step Action Since we do not have access to body fluids in our classroom situation, you will prepare a sample to simulate a body fluid as follows: Use the Dispense Diluent function on the instrument to dispense diluent into a clean tube. Do this twice using the same tube. Pipette approximately 100 μl of any blood sample into the diluent obtained from the instrument. This does not have to be an exact dilution. Mix thoroughly. Run the sample using the single-tube presentation. Choose a body fluid under Specimen Type and follow the on-screen directions. Please continue to the Skill Check on the next page. SO-50 of 60 Beckman Coulter Professional Development PN: A62452A (June 2013)

61 SAMPLE ANALYSIS SKILL CHECK 1. What is the specimen aspiration volume for the DxH 600 System? 2. State the maximum stability time for each of the following: At Room Temp. At Refrig. Temp. CBC NRBC Retic % Body Fluids 3. Show printouts of the various types of sample runs to your facilitator. 4. Navigate the Worklist screen tabs with your facilitator. 5. Show how to review and release a result. UniCel DxH 600 Operator Training Module PN: A62452A (June 2013) SO-51 of 60 Beckman Coulter Professional Development

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63 OBJECTIVES SETTING UP DXH SUPPLIES Using an operating DxH 600 System and System HELP: Setup and replace supplies using Beckman Coulter reagents and the bar code scanner Setup Reagent Configurations View and review the two history logs associated with Supplies Why Is It Important? An up-to-date supplies screen shows that your laboratory is aware of good Quality Assurance procedures. Even if the same lot number of a reagent replaces the previous container, the supplies setup must be updated to show the correct open container expiration date. Resources DxH 600 System System Help Reagent with Barcode UniCel DxH 600 Operator Training Module PN: A62452A (June 2013) SO-53 of 60 Beckman Coulter Professional Development

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65 INFORMATION/PRACTICE Entering information for DxH 600 System supplies is easy. You simply scan a bar code label and you are done. Read the Set-Up Supplies HELP topic in Chapter 9 for reference. Step 1 Action The Supplies screen displays the status of the supplies. The Beckman Coulter Supplies are displayed graphically as colored bottles. The colors on the supply screen correlate with the colors of the consumable connection tubes. The hand-held Bar-Code scanner lets you automatically upload DxH 600 Supply information from the Setup Supplies dialog box. Select the Supplies icon. Select Setup to set up supplies. 2 3 With the Setup Supplies dialog box open, scan the bar-codes on the Beckman Coulter reagent container and hit Enter. The supply information is updated. Note For Diluent Reagent only, select Diluent 1 or Diluent 2. 4 Select OK to complete the setup, or Next to configure another supply. When any reagent supply is getting low, a yellow Supplies icon appears. When any reagent supply is out, a red Supplies icon appears. UniCel DxH 600 Operator Training Module PN: A62452A (June 2013) SO-55 of 60 Beckman Coulter Professional Development

66 With two diluents, when the first box is getting low, the field is yellow, but the icon remains neutral. Once it switches to the second box, the icon is yellow and the field is red. Do not change Diluent 1 until the switch to Diluent 2 occurs. Otherwise, it will never switch. Configuring Containers You can configure the system to run with one diluent container, or two (dual) containers. The system will automatically switch between two containers if so configured. This exercise shows you where to select single or dual containers. Read the Configuring Containers HELP topic in Chapter 9 for reference. Step Action 1 Select the Supplies Icon > Configure Containers. You may select either the Single Container or Dual Container option from the Diluent drop-down list. 2 For Classroom purposes, make sure the Dual Container option is selected. 3 Select the OK button to save your selection. In the classroom, we use the dual container set up. Note on the Supplies screen that both containers list separately. They are also used separately, meaning one container empties and then it switches automatically to the second container. When this occurs, the Supplies Alert Status Icon is yellow; indicating one of the containers needs to be replaced at your convenience. SO-56 of 60 Beckman Coulter Professional Development PN: A62452A (June 2013)

67 Configuring Low-Level Condition Step 1 Action The Configure Low Level option lets you to set a warning level to alert you when a supply is running low based on the remaining percentage of that supply. Refer to Chapter 9. Select the Supplies Icon > Configure Low Level. Select a percentage from the drop-down list. 2 In the classroom, we set the low-level warning to 10%. When this occurs, the Supplies Alert Status Icon is yellow. If both supplies are out, the icon is red. 3 Select OK. Supplies History Logs There are two history logs associated with Supplies. One is located under Event Logs and the other is located under Data Summary Logs. Supplies Event Log This log records any changes or alerts associated with the supplies. For example, when the diluent switches from one container to the other, it causes a yellow Supplies Alert Status Icon. Supplies Data Summary Log This log records all the information on each new container set up on the System. Find both of these logs and examine the entries in each one. UniCel DxH 600 Operator Training Module PN: A62452A (June 2013) SO-57 of 60 Beckman Coulter Professional Development