UniCel DxH 800 Coulter Cellular Analysis System Training Modules

Transcription

1 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.

2 UniCel DXH 800 TRAINING MODULES WARNINGS AND PRECAUTIONS READ ALL PRODUCT MANUALS AND CONSULT WITH BECKMAN COULTER-TRAINED PERSONNEL BEFORE ATTEMPTING TO OPERATE INSTRUMENT. DO NOT ATTEMPT TO PERFORM ANY PROCEDURE BEFORE CAREFULLY READING ALL INSTRUCTIONS. ALWAYS FOLLOW PRODUCT LABELING AND MANUFACTURER S RECOMMENDATIONS. IF IN DOUBT AS TO HOW TO PROCEED IN ANY SITUATION, CONTACT YOUR BECKMAN COULTER REPRESENTATIVE. HAZARDS AND OPERATIONAL PRECAUTIONS AND LIMITATIONS WARNINGS, CAUTIONS and IMPORTANTS alert you as follows: WARNING Can cause injury. CAUTION Can cause damage to the instrument. IMPORTANT Can cause misleading results. 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 ANALYZER. WARNING Risk of operator injury if: All doors, covers and panels are not closed and secured in place prior to and during instrument operation. The integrity of safety interlocks and sensors is compromised. Instrument alarms and error messages are not acknowledged and acted upon. You contact moving parts. You mishandle broken parts. Doors, covers and panels are not opened, closed, removed and/or replaced with care. Improper tools are used for troubleshooting. To avoid injury: Keep doors, covers and panels closed and secured in place while the instrument is in use. Take full advantage of the safety features of the instrument. Do not defeat safety interlocks and sensors. Acknowledge and act upon instrument alarms and error messages. Keep away from moving parts. Report any broken parts to your Beckman Coulter Representative. Open/remove and close/replace doors, covers and panels with care. Use the proper tools for troubleshooting. CAUTION System integrity might be compromised and operational failures might occur if: This equipment is used in a manner other than specified. Operate the instrument as instructed in the Product Manuals. 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. You install software that is not an original copyrighted version. Only use software that is an original copyrighted version to prevent virus contamination. IMPORTANT If you purchased this product from anyone other than Beckman Coulter or an authorized Beckman Coulter distributor, and, if it is not presently under a Beckman Coulter service maintenance agreement, Beckman Coulter cannot guarantee that the product is fitted with the most current mandatory engineering revisions or that you will receive the most current information bulletins concerning the product. If you purchased this product from a third party and would like further information concerning this topic, call your Beckman Coulter Representative. ii of iv

3 UniCel DXH 800 TRAINING MODULES 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 iii of iv

4 UniCel DXH 800 TRAINING MODULES REVISION STATUS Revision AB Initial Issue (November 2008) Software release and higher Revision AB.1 (August 2009) Software release and higher Revision AB.2 (February 2012) Software release and higher iv of iv

5 COURSE GUIDE Implement Electives Troubleshooting Setup Basics 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. 1 of 6

6 2 of 6

7 TRAINING TOPICS BASICS SETUP TROUBLESHOOTING ELECTIVES IMPLEMENTATION 3 of 6

8 4 of 6

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 Complete the Registration Questionnaire Instrument Demo Wednesday Thursday Friday Pro-Service Flags, Codes, & Messages Evaluations Graduation 5 of 6

10 6 of 6

11 BASIC OPERATION MODULES Implement Electives Troubleshooting Setup Basics 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. B-1 of 56

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 B-2 of 56

13 COURSE MAP - BASICS Begin Here DxH 800 Prerequisite CD System Basics Daily Checks Quality Control Running Samples Shutdown Supplies B-3 of 56

14 Name PERSONAL PROGRESS SUMMARY Basic Operation Modules Date Initial Facilitator DxH 800 Prerequisite CD System Basics Daily Checks Quality Control Running Samples Shutdown Supplies B-4 of 56

15 OBJECTIVES SYSTEM BASICS Given an operating DxH 800 System: Log On and Log Off the System Manager Identify the main hardware of the system by labeling a diagram Identify the areas of the optional floor stand 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 800 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 800 System DxH 800 Prerequisite CD B-5 of 56

16 B-6 of 56

17 INFORMATION/PRACTICE Logoff/Logon 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 Operator ID: BCI (case sensitive), press tab. 4 Type in the Password: bci (case sensitive). 5 Select the Log On button or Press Enter. You will now be on the DxH 800 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: Pentium Core 2 Duo, 2 GHz, 2 GB RAM 19 LCD flat panel monitor, touch screen 250 GB hard drive, internal 250 GB external, pluggable hard drive DVD +/- R/RW Drive Optical USB mouse Standard keyboard Hand-held barcode scanner B-7 of 56

18 Access System HELP 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. B-8 of 56

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, click on System Manager Indicators and scroll down to view the different names of the areas on this within the home screen. Note: This was reviewed in more detail in the DxH 800 Hematology Innovations CD that was sent to you as prerequisite material. B-9 of 56

20 Hardware Overview The DxH 800 System includes a Specimen Processing Module (SPM), a Pneumatic Supply Module (PSM) and a System Manager. 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 Select UniCel DxH 800 System. 5 Take some time to study the figure of the DxH 800 System. 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. 7 8 Note Next, go back to the Chapter 1 System Overview, expand Hardware, expand Inter-Unit Connections, select Front View of the SPM. Scroll down and 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. The two Beacon colors are Red (Cannot Run) or Green (OK to Run). The Optional Floor Stand Step Action 1 Select the Index tab. 2 Type floor stand. 3 Double click Floor Stand from the list. 4 Take some time to study the Floor Stand figures and their descriptions. You will label a diagram with the correct names as part of the skill check at the end of this module. B-10 of 56 Congratulations, you ve finished Basics! Continue to the Skill Check.

21 1. Label the sections of the Home screen: SYSTEM BASICS SKILL CHECK Label the main areas of the DxH 800 System: B-11 of 56

22 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. Label the parts of the optional Floor Stand: What do the colors mean? B-12 of 56

23 OBJECTIVES DAILY CHECKS Given an operational DxH 800 and using the System HELP: Point to the last time a Daily Checks or Shutdown was run using the System 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 automatic printing of the Daily Checks results 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. Resources DxH 800 System B-13 of 56

24 B-14 of 56

25 INFORMATION/PRACTICE The Daily Checks testing is a once-a-day procedure normally performed after running a system Shutdown cycle. Both of these cycles have autoprogram features. Even when you have the cycle pre-programmed, you may still request to perform a Daily Checks cycle at any time (for troubleshooting, etc.). Requesting a Daily Checks Cycle Step 1 Action Select the System Status icon. Look at the System 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 spheres for Operation, LIS Communication and Printer Queue Status. B-15 of 56

26 A green sphere means OK. A red sphere means a problem. A gray sphere means disabled. A black sphere means disconnected. 4 Look at the status in the upper left of the screen. Status may be Online, if running samples, Offline, for special cycles and procedures, Standby, for certain diagnostic tests. It may also state Calibration, Carryover or Repeatability when you run those procedures. Select the Daily Checks button from the top of the screen to display the Daily Checks Summary screen with results of the most recent Daily Checks. 5 6 Select the Daily Checks button at the bottom of the screen. A DxH 800 dialog box displays the following: You have requested to perform Daily Checks. 7 Select OK to run Daily Checks, or Select Cancel. 8 While this cycle is running (approx. 4.5 minutes), for additional reference refer to Daily Checks Help topic in Chapter 3. B-16 of 56

27 Reviewing the Daily Checks Step 1 Action Look at the Daily Checks icon. If it is neutral, all is well. If it is red, then something failed and needs review. When there is any result that fails, you need to acknowledge the value to return the status color to neutral to be able to run the instrument. Select the Review button near the bottom to acknowledge. 2 Look at each Daily Checks tab, beginning with the Summary tab. 3 If any Background result fails, run Daily Checks again. 4 5 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. After reviewing, select the Review button. 6 7 Note: 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. A dialogue window appears asking: Are you sure you want to acknowledge the Daily Checks failure? Press OK to continue. 8 Select OK. B-17 of 56

28 Auto-Configuration of Daily Checks 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. For classroom purposes, select Perform Daily Checks at a specified time. Hour will be 7, Min will be 45, and check the Daily check box. If you select to Perform Daily Checks After Shutdown, select OK to save. B-18 of 56

29 Viewing Past Results/Adding Comments Step Action 1 Select the View Log button from the Local Navigation Bar. 2 You may select one date at a time to review. 3 4 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 large back arrow on the upper left 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 there. You may go back to a comment to edit it as well. Be sure to save at least one comment for any Daily Checks result as part of this exercise. Printing/Auto-Printing Step Action From the Daily Checks screen, you may manually print individual results by selecting the print icon from the utility area at the upper right. You may choose to print Daily Checks Summary Report (one page) or Detail Checks Detail Report (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. Print two selections from the log, including today s results and one from a week ago. 4 You may decide to have the Daily Checks print automatically. 5 To do this, return to the Daily Checks screen by selecting the Daily Checks icon. B-19 of 56

30 6 7 Select the Auto Report button from the Local Navigation bar. This opens the Daily Checks Auto Report window. You may select to print automatically either the Summary report or the Details report, or both. 8 Choose Summary report and select OK. Please continue to the Skill Check on the next page. B-20 of 56

31 DAILY CHECKS 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. B-21 of 56

32 B-22 of 56

33 OBJECTIVES QUALITY CONTROL Given an operating DxH 800 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 800 System Control package inserts for Latron CP-X control, 6C, Retic-X and Body Fluid cell controls. Control products for processing B-23 of 56

34 B-24 of 56

35 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. B-25 of 56

36 Processing Controls Note: The DxH 800 System does not require reagent priming or whole blood priming before running controls or specimens in either the cassette or the single-tube presentation methods. Step 1 2 Action Ask your facilitator to provide you with a set of package inserts for all controls. Also, you will need the controls to run on your instrument. Please run all controls, all levels. Follow the instructions outlined in the package insert for Running the Controls. 3 4 To put the instrument Online, select the Start button upper right. Process all the controls (except Body Fluid) via cassette presentation. from the 5 After the cassettes are finished, follow the steps for single-tube presentation to process the Body Fluid controls. Reviewing Control Results Step Action Note: Read these sections to familiarize you with the various screens. Open the System HELP and select the Contents tab. Expand Chapter 4 Quality Control. Expand Overview, select Viewing Control Files Data View, and select Viewing Control Files Graphically. 1 Select the Quality Control status icon If any of the control runs had out-of-range values, a dialogue box opens with a list of those controls. If everything was within range, the Quality Control (Data View) screen opens. It displays whatever was the last control viewed. 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 can expand to choose the various controls and levels for review. B-26 of 56

37 3 Highlight the control you wish to view and select OK. 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 Reviewed By area under the column to show that the run had a review. Do this for all your control runs for this exercise. In your lab, follow your laboratory s protocol. B-27 of 56

38 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. B-28 of 56

39 QUALITY CONTROL SKILL CHECK 1. Have facilitator check the answers on page B 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. B-29 of 56

40 B-30 of 56

41 OBJECTIVES RUNNING PATIENT SAMPLES Given an operating DxH 800, access to System HELP and blood specimens collected in EDTA anticoagulant: State the aspiration volume for sampling Identify the four types of cassettes (A, B, C, D) and the tubes to use in each Process bar coded samples using cassette presentation Process bar coded samples using single-tube presentation 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 Identify the populations on the 2-D Dataplot for Diff, NRBC and Retic Enlarge the Histograms and the 2-D Dataplot Diff, NRBC and Retic Why Is It Important? Running samples is a daily task that occupies much of your time in the lab. Learning how to process samples efficiently on the DxH 800 saves you time. Resources DxH 800 System Blood specimens collected in EDTA Bar code labels Cassettes Pipettors, tips and clean tubes Microtainers B-31 of 56

42 B-32 of 56

43 INFORMATION/PRACTICE Specimen Information Notes Whole Blood: 1 Collect whole blood in EDTA according to tube manufacturer s instructions and procedures in: CLSI publication H4-A5 (for capillary) CLSI publication H3-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. Aspiration: 3 DxH 800 aspiration volume is 165 µl. Pre-diluted blood CBC analysis requires a dilution of 50 µl and 200 µl of diluent. B-33 of 56

44 Sample Stability (Whole Blood and Body Fluids): 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 Body Fluids: Per established literature, Body Fluids samples should be stored at room temperature and analyzed within 1 hour of collection. 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 Cassette Presentation (LIS Bidirectional Download to Pending) Obtain specimens and barcode labels from your facilitator. This section assumes bidirectional LIS download and positive identifier set to Specimen ID. Step Action The SPM must be online to run samples. You can view the status of the SPM in the Status Mode area at the upper left hand corner of any screen. 1 B-34 of 56

45 2 Ensure your specimens have been collected and stored properly. Load the specimens into the cassette. 3 Place the cassettes into the input buffer to the right of the SPM. The SPM automatically begins cycling the cassettes. 4 B-35 of 56

46 Single-Tube Presentation Obtain another bar-coded specimen. Step 1 Action Select the Single-tube Presentation icon The single-tube Presentation Dialog Box will come up. 2 Place the specimen on the bar-code reader platform. If you type or scan the specimen identifier, you need to press enter. 3 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. B-36 of 56

47 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 3 Follow the directions on the screen, using an empty tube. 4 Prepare your x5 dilution. (Example: 50uL of sample and 200uL of diluent). B-37 of 56

48 Running Sample in Predilute Function (Cont.) Step Action 5 If SPM timed out, select the Single-tube Presentation icon. Scenario One Specimen ID in the Pending List 1. Identify the specimen and press Enter. Scenario Two Specimen ID is Not in the Pending List 1. Identify the specimen and press Enter. 2. Press Edit Order button. 2. The Dialog Box comes up Test Order not Found Default Test Order Assigned. Select OK. 3. Highlight the Selected Panel and click Remove. Then, select the Available Panel PREDIx5 and click Add. 3. Select the Available Panel PREDIx5. Click Add. 4. Press the Submit button. 4. Press the Submit button. 6 Place the specimen into the correct Single-tube position. 7 Once the sample is aspirated and the tube is returned. 8 Select the button to finish. B-38 of 56

49 Body Fluids (Optional) 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. The Body Fluid mode provides extra cleanup after running this type of sample. Reviewing Sample Results 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) or you can review the results from the System Manager. To view results select the Review or Released tab, highlight a result and select the Details button. For additional information, review the information in Help, Chapter 6 Data Review. If there was a processing problem such as a No Read or No Match, the sample is not aspirated and the request posts to the Not Processed tab. The samples posted here need to be investigated as to the problem. Clear them from the list using the Clear button. Place these samples back in the input buffer to process again. 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). B-39 of 56

50 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. 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. Please continue to the Skill Check on the next page. B-40 of 56

51 RUNNING PATIENT SAMPLES SKILL CHECK 1. What is the specimen aspiration volume for the DxH 800? 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. B-41 of 56

52 B-42 of 56

53 OBJECTIVES SHUTDOWN Given an operating DxH 800 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 automatic Shutdown to occur from Monday thru Friday at 17:30 Why Is It Important? To ensure optimal cleaning of the instrument, the Shutdown procedure must be performed every day that the instrument is used. Resources DxH 800 System B-43 of 56

54 B-44 of 56

55 INFORMATION/PRACTICE The DxH 800 allows you to program the length of time the instrument is in Shutdown. Read the Shutdown HELP topic in Chapter 8 for reference. At the end of your 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. The default time is 30 minutes. This is the minimum time required for Shutdown. You may increase the time to up to 24 hours. 1 2 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. 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. B-45 of 56

56 Auto Configuration of Shutdown The DxH 800 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 17:30 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. B-46 of 56

57 SHUTDOWN SKILL CHECK 1. What is the minimum time for the DxH 800 to be in shutdown? 2. How often should a Shutdown cycle be performed? 3. What step would you take if shutdown is programmed for one hour and you get a STAT after only 15 minutes has elapsed? B-47 of 56

58 B-48 of 56

59 OBJECTIVES SUPPLIES Using an operating DxH 800 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 800 System System Help Reagent with Barcode B-49 of 56

60 B-50 of 56

61 INFORMATION/PRACTICE Entering information for DxH 800 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 hand-held Bar-Code scanner allows you to automatically upload DxH 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. 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. B-51 of 56

62 Configure Diluent Containers The DxH 800 System uses DxH Diluent that is in a 10L container. You have the option of using one or two containers. This exercise shows you where to select single or dual containers. Read the Configure Containers HELP topic in Chapter 9 for reference. Step Action 1 You can configure the system to run with one diluent container, or two (dual) diluent containers. The system will automatically switch between two containers if so configured. Select the Supplies Icon > Configure Containers. 2 You may select either the Single Container or Dual Container option from the Diluent drop-down list. 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. B-52 of 56

63 Configure Low Level Condition Step Action 1 The Configure Low Level option allows 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. B-53 of 56

64 You reached the goal! Please continue to the Skill Check on the next page. B-54 of 56

65 SUPPLIES SKILL CHECK 1. Show facilitator the entry of the reagent you changed. 2. Show facilitator the Supplies screen. 3. Show facilitator both history logs associated with Supplies. 4. Show facilitator the position of Diluent 1 and Diluent 2 on the Instrument. B-55 of 56

66 B-56 of 56