UniCel DxH Series Coulter Cellular Analysis System Training Pocket Resources

Transcription

1 UniCel DxH Series Coulter Cellular Analysis System Training Pocket Resources 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 Series Training Pocket Resources Rev. A (June 2014)

2 UNICEL DXH SERIES COULTER CELLULAR ANALYSIS SYSTEM TRAINING POCKET RESOURCES 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 vi UniCel DxH Series Training Pocket Resources Rev. A (June 2014)

3 UNICEL DXH SERIES COULTER CELLULAR ANALYSIS SYSTEM TRAINING POCKET RESOURCES REVISION STATUS Revision A (June 2014) Software release 1.0 Presented June 2014, Miami, Florida The information contained in this manual has been reviewed and approved. The references listed below have been combined. The materials are linked to the following references: UniCel DxH Pocket Resources Revision B (December 2013) Software release 2.0 Presented March 2013, Miami, Florida UniCel DxH 800 Training Resources Revision A (March 2013) Software release 2.0 Presented June 2013, Miami, Florida UniCel DxH Slidemaker Stainer Training Resources Revision A (March 2013) Software release 2.0 Presented June 2013, Miami, Florida UniCel DxH Series Training Pocket Resources Rev. A (June 2014) iii of vi

4 UNICEL DXH SERIES COULTER CELLULAR ANALYSIS SYSTEM TRAINING POCKET RESOURCES iv of vi UniCel DxH Series Training Pocket Resources Rev. A (June 2014)

5 UniCel DxH Series Coulter Cellular Analysis System Training Pocket Resources TRAINING RESOURCES TOPICS UNICEL DXH SERIES JOB AIDS UNICEL DXH SERIES CLEANING PROCEDURE CHART UNICEL DXH SERIES COMPETENCY CHECKLIST EXAMPLES OF PATIENT RESULTS TROUBLESHOOTING PROCEDURES UNICEL DXH SLIDEMAKER STAINER JOB AIDS UNICEL DXH SLIDEMAKER STAINER CLEANING PROCEDURE CHART UNICEL DXH SLIDEMAKER STAINER COMPETENCY CHECKLIST STAIN PROTOCOLS STEPS ON ACCESSING TRAINING MATERIALS ON THE WEB UniCel DxH Series Training Pocket Resources Rev. A (June 2014) v of vi

6 UniCel DxH Series Coulter Cellular Analysis System Training Pocket Resources vi of vi UniCel DxH Series Training Pocket Resources Rev. A (June 2014)

7 UniCel DxH 800/DxH 600 Coulter Cellular Analysis System Front View Specimen Processing Module (SPM) Rev. A (June 2014) 1 of 118

8 UniCel DxH 800/DxH 600 Coulter Cellular Analysis System System Overview Rev. A (June 2014) 2 of 118

9 UniCel DxH 800 Configuration Only Floor Stand Rev. A (June 2014) 3 of 118

10 UniCel DxH 800/DxH 600 & DxH Slidemaker Stainer Coulter Cellular Analysis System Log off / Log on Step To Log Off from the System Manager 1 Select the Log off icon at the top right of the screen. On the Log off screen, select the Log off button. 2 3 You are now logged off from the System Manager. To Log On to the System Manager On the Log On screen, type in the Operator ID, press tab (case sensitive). 1 2 Type in the Password (case sensitive). 3 Select the Log On button or Press Enter. 4 You are now logged on to the System Manager. Rev. A (June 2014) 4 of 118

11 UniCel DxH 800/DxH 600 & DxH Slidemaker Stainer Coulter Cellular Analysis System Home Screen Status Area 5. System Status Icon 2. Navigation Icons 6. Alert Status Icons 3. Local Navigation Icons 7. Utility Icons 4. Status Bar 8. System Icons Rev. A (June 2014) 5 of 118

12 UniCel DxH 800/DxH 600 & DxH Slidemaker Stainer Coulter Cellular Analysis System Access System Help Step 1 Select the System HELP icon. 2 You may search for topics using: Content, Index and Search tabs located on the left side of Help. 3 To place topic in Favorites as a reference, select the Favorites tab. 4 Locate a specific topic of interest. 5 Then, select the Add button at the bottom of the display. 6 You may now refer to this topic any time you select Favorites. 7 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. 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 to read. 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. 11 To close Help, select X Rev. A (June 2014) 6 of 118

13 UniCel DxH 800/DxH 600 Coulter Cellular Analysis System System Status & Details Status Screens Step Select the System Status icon. This screen gives you an overview of the system. System Status Transport Status Instrument Status 1 LIS Status Printer Status Details Status Rev. A (June 2014) 7 of 118

14 Step Click on Details Status button, or double click on the instrument silhouette to view the systems status details. Date & Time of last Daily Check & Shutdown Cycles Displays the Status of the Unit 2 Date/Time of Last Control Run Default Test Order Automatic: Specimen - Cassette Manual: Specimen - Single-Tube Date/Time of Last Calibration Change Transport Status Transfers Rev. A (June 2014) 8 of 118

15 UniCel DxH 800/DxH 600 Coulter Cellular Analysis System Daily Checks Step Select the Daily Checks button to display the Daily Checks Summary screen with results of the most recent Daily Checks. 1 2 Select Daily Checks from the local navigation bar. A dialog box displays the following: Are you sure you want to start a Daily Checks procedure? Press OK to continue. 3 Select OK to run Daily Checks, or Select Cancel. 4 The Daily Checks takes approx 4.5 minutes. For additional reference, refer to Daily Checks Help topic Chapter 3. Rev. A (June 2014) 9 of 118

16 Reviewing the Daily Checks Step 1 Look at the Daily Checks alert status 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. 2 Look at each Daily Checks tab, beginning with the Summary tab. 3 If any Background result fails, run Daily Checks again. 4 Verify your background results when the Daily Checks cycle finishes. 5 You may view the Daily Checks log entries and any areas that failed within the Daily Checks will be backlit in red and have a Fail status posted. Rev. A (June 2014) 10 of 118

17 UniCel DxH 800/DxH 600 Coulter Cellular Analysis System Shutdown The DxH System allows you to program the length of time the instrument is in Shutdown. Beckman Coulter recommends that the SPM remain in cleaner for at least 30 minutes every 24 hours. Shutdown can be initiated manually or automatically. NOTE: If the instrument exceeds 24 hours without having a shutdown performed, the DxH 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 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 1 From the Daily Checks screen, select the Shutdown button to display the Manual shutdown dialog box Select the Perform Startup After Shutdown check box to automatically begin Daily Checks after shutdown is completed. Type a number in the Time in Cleaner Hours and Minutes check boxes to determine the time in cleaner. Note: No other cycles or System Manager actions can be performed until the Shutdown cycle has completed. Once the Shutdown cycle is complete, a countdown timer bar appears at the bottom of the Daily checks screen to let you know how much time remains for the cleaning. 5 Select OK to begin shutdown or Cancel to exit. Rev. A (June 2014) 11 of 118

18 UniCel DxH 800/DxH 600 Coulter Cellular Analysis System Quality Control Step The frequency of running controls is dependent upon regulatory and laboratory policy for quality assurance programs. 1 2 Remove control tube(s) from the refrigerator and warm at AMBIENT TEMPERATURE for minutes. After warming, mix by hand as follows: a. Roll the tube slowly between the palms of the hands eight times in an upright position. b. Invert the tube and slowly roll it between the palms eight times. c. Gently invert the tube eight times. 3 Repeat steps 2a to 2c for 6C Controls and Body Fluids Controls. For Retic-X, Inpect the tube contents for complete resuspension. If necessary, repeat steps 2a to 2c until tube contents are uniformly suspended. Do Not Over Mix. DO NOT use any type of mechanical mixer. 4 To put the instrument Online, select the Start button from the upper right. 5 Process all the controls (except Body Fluid) via cassette presentation. 6 After the cassettes are finished, follow the steps for single-tube presentation to process the Body Fluid controls. 7 Return the control tube(s) to the refrigerator within 30 minutes. Rev. A (June 2014) 12 of 118

19 Reviewing Control Results Step 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 with the last control that was viewed. 2 3 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. 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 review of the Levey-Jennings graphs. from the local navigation bar. This allows 5 Return to the data screen by selecting the View Data button. 6 Select the Comment button You may add to or edit comments. from the local navigation bar. 7 Select the Reviewed By area under the column to review controls. In your lab, follow your laboratory s protocols for reviweing control results. Rev. A (June 2014) 13 of 118

20 UniCel DxH 800/DxH 600 Coulter Cellular Analysis System Supplies Step 1 The hand-held Bar-Code scanner allows you to automatically upload DxH Supply information from the Setup Supplies dialog box. Select the Supplies icon from the Alert Status Icons. 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. Rev. A (June 2014) 14 of 118

21 Configure Diluent Containers Step 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. 1 Select the Supplies icon > Configure Containers. 2 You may select either the Single Container or Dual Container option from the Diluent drop-down list. 3 Select the OK button to save your selection. Configure Low Level Condition Step 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. Select the Supplies icon > Configure Low Level. Select a Percentage from the drop-down list. 2 Note: When the low level is triggered Supplies Alert Status Icon turns yellow. If both supplies are out, the icon is red. 3 Select OK. Rev. A (June 2014) 15 of 118

22 UniCel DxH 800/DxH 600 Coulter Cellular Analysis System Running Patient Samples Cassette Presentation (LIS Bidirectional Download to Pending) Step 1 You may view the status of the SPM in the System Status Screen or the Details Status Screen. Place the SPM online to run samples by pressing the start button. 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 Rev. A (June 2014) 16 of 118

23 Single Tube Presentation Step 1 Select the Single-tube presentation icon. The Single-tube Presentation Dialog Box will come up. 2 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. 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. Rev. A (June 2014) 17 of 118

24 Running a Sample in the Predilute Function Step 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). Rev. A (June 2014) 18 of 118

25 Running Sample in Predilute Function (Cont.) Step 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. Rev. A (June 2014) 19 of 118

26 Step 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. Rev. A (June 2014) 20 of 118

27 UniCel DxH 800/DxH 600 Coulter Cellular Analysis System Calibration Step NOTE Before you can start or restart the calibration process, the SPM must be offline. Select Menu>QA>CBC Calibration 1 2 Select Calibration Setup on the CBC Calibration Screen to display the CBC Calibration Setup dialog box. The screen will have the results of the last calibration run that was performed. You will be prompted by a dialog box which states: Existing Data will be deleted. Select OK to continue. Select OK. 3 Type 10 in the Number of Aspirations text box. 4 Select Cassette Presentation Mode from the drop-down list. 5 Select BCI from the Calibrator Type drop-down list. 6 Select New Control From Bar Code and use the handheld bar-code scanner to scan the 2D bar code on the product insert or enter/select the following information: Lot# Expiration Date Reference Values Rev. A (June 2014) 21 of 118

28 Step 7 Select OK and follow the screen prompts. 8 9 Place the calibrator in a cassette and place it in the input buffer. Select OK. Review the calibration results. If the procedure indicates you need to calibrate, continue with the calibration procedure. 10 Select the Finish button at the bottom of the screen. 11 If a parameter needed to be calibrated, perform calibration verification by running the 6C controls. Additional Information When To Calibrate and When To Verify When to Calibrate You should calibrate your instrument: At installation. After replacement of any component that involves dilution characteristics (such as the BSV) or the primary measurements (such as the apertures). When advised to do so by your Beckman Coulter Representative. If you fail verify calibration procedure. When to Verify You should verify the calibration of your instrument: As dictated by your laboratory procedures, local or national regulations. When controls begin to show evidence of unusual trends. When controls exceed the manufacture s defined acceptable limits. If the average ambient room temperature changes more than 10F or 12F from the calibrating temperature. Rev. A (June 2014) 22 of 118

29 Front Blood Detector UniCel DxH 800/DxH 600 Coulter Cellular Analysis System Front Area For Information Use Only. Do Not Remove the Covers Unless You are Instructed by a Beckman Coulter Representative. Probe Vacuum Manifold Hamilton Syringe Probe Waste Line BSV Aspiration Probe Rear Blood Detector Behind the Sample Aspiration Mode (SAM) BSV Drip Tray Vacuum Regulator Bleach Port Vacuum Regulator Fitting #2 Vacuum Regulator Fitting #1 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. Rev. A (June 2014) 23 of 118

30 UniCel DxH 800/DxH 600 Coulter Cellular Analysis System Front Area Air Mix Temperature Control (AMTC) Module NRBC Mixing Chamber Diff Mixing Chamber Retic Clearing Mixing Chamber Retic Stain Mixing Chamber Single Tube Presentation Barcode Camera Left Cradle Right Cradle Rev. A (June 2014) 24 of 118

31 UniCel DxH 800/DxH 600 Coulter Cellular Analysis System Right Side Area FMI Pumps Sheath Regulator Sample Regulator VCSn Waste Chamber Sample Tank Sheath Tank Solenoids 25 psi Chamber Rev. A (June 2014) 25 of 118

32 FMI Pumps UniCel DxH 800/DxH 600 Coulter Cellular Analysis System Left Side Area RBC Bath Hemoglobin Lamp WBC Count Chamber Hemoglobin Cuvette RBC Count Chamber WBC Bath Foam Trap Rev. A (June 2014) 26 of 118

33 UniCel DxH 800/DxH 600 Coulter Cellular Analysis System Multi-Transducer Module (MTM) Flow Cell Rev. A (June 2014) 27 of 118

34 UniCel DxH 800/DxH 600 Coulter Cellular Analysis System Cell Population MONOS NEUTS EOS LYMPHS BA NON-WHITE CELLS PLT/DEBRIS WBC MATURE RBC S WBC S RETICS NRBC PLT/DEBRIS Rev. A (June 2014) 28 of 118

35 All System messages are accompanied by R (Review) flags. Exceptions are the System Messages associated with an Aspiration error (P Flag) and the Non-Blood Specimen message (N Flag). SYSTEM MESSAGE DXH WBC Abn WBC Pattern Cellular Inter System Event: WBC WBC Carryover RBC Abn RBC Pattern System Event: RBC HGB HGB Inter: WBC HGB Blank Shift System Event: HGB MCV MCV Inter: PLT MCV Inter: WBC DIFF Abn Diff Pattern Aged Sample Data Disc: D Excessive Debris: D High Event Rate: D High OP Events: D High RF Events: D Low Event Rate: D Low Events: D Low OP Events: D Low RMALS Events: D MO-NE Overlap NE-EO Overlap System Event: D Undefined Pop: D RETIC Abn Retic Pattern AL2 Blank Volt: R Data Disc: R High Event: R Low Event: R Nucleated Cells RET Inter: Debris RET Inter: PLT RET-RBC Overlap System Event: R SYSTEM MESSAGE DXH PLT Platelet Clumps PLT Carryover PLT Inter: Debris RBC-PLT Overlap System Event: PLT NRBC Abn NRBC Pattern AL2 Blank Volt: N DataDisc: N High Event Rate: N Low AL2 Events: N Low DC Events: N Low Event Rate: N Low Events: N NRBC Inter NRBC-LY Overlap System Event: N BF Abn TNC Pattern System Event: TNC TNC Carryover P Bubbles Carryover No Aspiration Non-blood Specimen Partial Aspiration Range Error Unknown Error ::::: Code Flow Cell Clog: D Flow Cell Clog: N Flow Cell Clog: R Rev. A (June 2014) 29 of 118

36 RBC Histogram Examples NORMAL RBC AGGLUTININ MACROCYTIC, Elevated RDW RBC Fragments / DI RBC / Elevated RDW DI RBCs, RBC Frags, Elevated RDW Rev. A (June 2014) 30 of 118

37 WBC Histogram Examples Lymphs Normal Mononuclear Granulocytes Left Shift ImmGr Lymphocytosis Variant Lymph Cellular Interference Eosinophilia Blasts Rev. A (June 2014) 31 of 118

38 PLT Histogram Examples Normal Small Platelets Giant Platelets RBC / PLT Overlap Rev. A (June 2014) 32 of 118

39 Better Abnormal Cell Detection MO Blasts 2 NE Blasts 3 Immature Granulocytes 4 Band Neutrophils 5 LY Blasts 6 Variant Lymphocytes 7 Small Lymphs / Low Opacity 8 Non-White Cells 8 Rev. A (June 2014) 33 of 118

40 UniCel DxH 800/ DxH 600 Coulter Cellular Analysis System Additional Information 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. Event Log All subcategories (System Status, Supplies, QC, QA, XB/XM, Patients, General) Max of 5000 events, No limit on time, all instruments. Data summary Logs Supplies: Max of 500 events, No limit on time, per instrument. Daily Checks: Max of 200 events, No limit on time, per instrument. Audit Logs Audit Log: Max of 30,000 events, 731 days, all instruments. Maintenance Logs All subcategories (Maintenance, Service): Max of 5000 events, No limit on time, per instrument. Specimen Preparation The aspiration pump activates and aspirates 165 µl of sample (Cassette or Single Tube Presentation). After the probe is removed from the specimen tube a second pull of the aspiration pump draws the blood through the BSV pathway, verifying a proper aspiration at the blood detectors. WBC Dilution ~6.0 ml of DxH diluent ~28 µl of sample Final dilution ~1.08 ml of DxH Cell Lyse RBC Dilution ~10.0 ml of DxH diluent ~1.6 µl of sample Final dilution AMTC (Air Mix and Temperature Control) NRBC: 27 µl of sample Diff: 34 µl of sample Retic Stain: 29 µl of sample Retic Clearing: 4 µl from the Retic Stain Chamber Note: Probe discards ~4.0 µl of sample between each dispense in the AMTC. Rev. A (June 2014) 34 of 118

41 UniCel DxH 800/DxH 600 Coulter Cellular Analysis System Body Fluid Notes from DxH Instructions for Use Manual (IFU AG Nov 2010) 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. Beckman Coulter recommends that a diluent be run as a Body Fluid sample prior to analysis of Body Fluid specimens. Backgrounds within specifications can influence the reported results on the samples with low abnormal or normal values. Beckman Coulter recommends that each laboratory establish criteria for evaluation of the impact on the background on the reported results. Table 1.14 Background - Body Fluids* * Analyzed by running a diluent using the Body Fluid Count cycle. Table 1.11 Body Fluids (CSF, Serous, Synovial) Measuring and Operating Ranges Body Fluids Reference Ranges Reportable body fluid results obtained from the DxH System may exceed commonly accepted normal reference ranges for all body fluids. Results should always be interpreted in light of the total clinical presentation of the patient, including clinical history, data from additional tests, and other appropriate information. Cerebrospinal Fluid The inability to collect cerebrospinal fluid specimen in the normal, non-diseased population limits the ability to determine reference ranges. Literature (Kjeldsberg C, Knight J. Body Fluids: Laboratory Examination of Cerebrospinal, Seminal, Serous & Synovial Fluids. 3rd Ed., ASCP Press, Chicago, IL 1993.) suggests the following normal reference ranges. WBC 0-5 cells/mm3 in adults WBC 0-30 cells/mm3 in children 1 to 4 years of age WBC 0-20 cells/mm3 in children 5 years of age to puberty RBC none to few Rev. A (June 2014) 35 of 118

42 Serous Fluids The accumulation of fluid in a serous cavity is an indication of a disease state. The normal, non-diseased population has no fluid accumulation. Therefore, there are no normal reference ranges for serous fluids. However, the number of cells present in a serous fluid are used to aid in the classification, diagnosis and treatment of disease. (Kjeldsberg C, Knight J. Body Fluids: Laboratory Examination of Cerebrospinal, Seminal, Serous & Synovial Fluids. 3rd Ed., ASCP Press, Chicago, IL 1993.) Synovial Fluid The inability to collect synovial fluid specimens in the normal, nondiseased population limits the ability to determine reference ranges. Literature suggests the following normal reference ranges. WBC cells/mm3 RBC none Sample Stability and Storage Per established literature, Body Fluid samples should be stored at room temperature and analyzed within 1 hour of collection. IMPORTANT Refer to CLSIH18-A3, Procedure for handling and Processing of Blood Specimen for guidelines. Overview The following types of sample can be analyzed on the SPM. Anti-coagulated human whole blood in K2 or K3 EDTA Prediluted anti-coagulated human blood in K2 or K3 EDTA Human Cerebrospinal fluid (CSF) Human Synovial fluid in K2 or K3 EDTA or Heparin (pretreated with Hyaluronidase) Human Serous fluids in K2 or K3 EDTA Body Fluids (Pre-treating synovial fluids) 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. Body Fluids (Definition) Fluids that are excreted, secreted, or derived form the human body. Some examples are: cerebrospinal fluid (brain and spinal cord), pericardial fluid (heart), peritoneal dialysis fluid (abdomen), peritoneal lavage fluid (abdomen), peritoneal tap fluid (abdomen), pleural fluid (lungs), and synovial fluid (joints). Rev. A (June 2014) 36 of 118

43 UniCel DxH Series Cleaning Procedures Month: Year: Serial #: System ID: DAILY Perform Shutdown Perform Daily Checks - Verify that all results are within limits Process Controls As Needed Clean (Bleach) the Apertures Clean the Aspiration Probe Clean the BSV Externally Clean the Pneumatic Supply Module Fan Filter Clean the STM Clean the Air Mix Temperature Control (AMTC) Module Clean the Vacuum Trap Clean the Optical Sensors Clean the Handheld Bar-Code Scanner Tech Initials Rev. A (June 2014) 37 of 118

44 Rev. A (June 2014) 38 of 118

45 Competency Checklist UNICEL UNICEL DXH SERIES 600 COULTER COULTER CELLULAR ANALYSIS SYSTEM CELLULAR ANALYSIS SYSTEM Task Resource How Measured? IDENTIFY POTENTIAL HAZARDS AND SAFETY FEATURES Review MSDS m MSDS manual in lab Direct Observation Recognize Hazard Symbols System HELP Direct Observation IDENTIFY AND BRIEFLY EXPLAIN FUNCTION OF ANALYZER COMPONENTS OVERVIEW OF SCREENS AND SOFTWARE Identify System Manager Icons and Screens Training Manual System HELP Training Manual System HELP Direct Observation Direct Observation Use System HELP Direct Observation MANAGE REAGENTS AND CONSUMABLES Setup new lot number for Latron CP-X, 6C, Retic-X and Body Fluid Controls Training Manual System HELP Direct Observation Replace reagent container Direct Observation DAILY CHECKS AND SHUTDOWN PROCEDURES Perform a Daily Checks Cycle & Review the Results Training Manual System HELP Direct Observation Achieved? Y N N/A Date Trainee Initial Trainer Initial Rev. A (June 2014) 39 of 118

46 Competency Checklist UNICEL UNICEL DXH SERIES 600 COULTER COULTER CELLULAR ANALYSIS SYSTEM CELLULAR ANALYSIS SYSTEM Task Resource How Measured? Perform a Shutdown Direct Observation Achieved? Y N N/A Date Trainee Initial Trainer Initial QA/QC Procedures Demonstrate proper handling of Latron CP-X, 6C, Retic-X and Body Fluid Controls Run Latron CP-X, 6C, Retic-X and Body Fluid Controls Review QC results per laboratory protocol Rev. A (June 2014) Training Manual System HELP Product Package Inserts Lab SOP Direct Observation Direct Observation Direct Observation Direct Observation Download QC files for IQAP Direct Observation Perform Calibration Direct Observation Perform Repeatability and Carryover Procedures PROCESS SAMPLES AND QUALITY CONTROL MATERIALS Training Manual System HELP Lab SOP Direct Observation Load cassette with samples Direct Observation Run control/sample using Cassette Presentation with barcode ID and without Run control/sample using Single-tube Presentation Direct Observation Direct Observation 40 of 118

47 Competency Checklist UNICEL UNICEL DXH SERIES 600 COULTER COULTER CELLULAR ANALYSIS SYSTEM CELLULAR ANALYSIS SYSTEM Task Resource How Measured? with barcode ID and without Retrieve Patient Results Direct Observation Achieved? Y N N/A Date Trainee Initial Trainer Initial Demonstrate how to transmit/re-transmit results to the LIS Reprint a Patient result from the System Manager Review sample results for flags, codes or messages Direct Observation Direct Observation Direct Observation Cleaning/Replacing System HELP Procedures as needed Clean (Bleach) the Apertures Direct Observation Clean the Aspiration Probe Direct Observation Clean BSV externally Direct Observation Clean the Pneumatic Supply Fan Filter Direct Observation Clean the STM Direct Observation Clean the AMTC Direct Observation Clean the Vacuum Trap Direct Observation Rev. A (June 2014) 41 of 118

48 Competency Checklist UNICEL UNICEL DXH SERIES 600 COULTER COULTER CELLULAR ANALYSIS SYSTEM CELLULAR ANALYSIS SYSTEM Task Resource How Measured? Clean the Optical Sensors Direct Observation Clean the Cassettes Direct Observation Replace the Aspiration Probe Direct Observation Replace Reagent Containers Direct Observation Replace Waste Containers Direct Observation Replace the Pneumatic Supply Module (PSM) Replace the Hand-held Bar-Code Scanner RESOURCES IFU System HELP Training Material Laboratory Protocol Direct Observation Direct Observation Direct Observation Achieved? Y N N/A Date Trainee Initial Trainer Initial Rev. A (June 2014) 42 of 118

49 UniCel DxH 800/DxH 600 Coulter Cellular Analysis System Cellular inter: Pattern consistent with NRBC detection during a CBC only cycle. This Cellular Interference Suspect message is not associated with a Review (R) flag. Cellular inter: Poor separation between a WBC population and interference. WBC correction was performed as a best estimation, and the WBC was flagged with R. Data Fusion saw NRBC and corrected the WBC count. The R flag means review the results. CBC only was ordered or run. A CBC was only ordered. No NRBC % results or NRBC Suspect Message obtained. Rev. A (June 2014) 43 of 118

50 UniCel DxH 800/DxH 600 Coulter Cellular Analysis System Cellular Inter: Pattern consistent with NRBC detection during a CBC only cycle. This Cellular Interference Suspect message is not associated with a Review (R) flag. Cellular Inter: Poor separation between a WBC population and interference. WBC correction was performed as a best estimation, and the WBC was flagged with R. Data Fusion saw NRBC and corrected the WBC count. The R flag means review the results. A CBC was only ordered. No NRBC % results or NRBC Suspect Message obtained. Why do I have both Cellular inter Messages? (Suspect and System) Pattern consistent with NRBC detection during a CBC only cycle. Poor separation between a WBC population and interference. Yellow results means: Outside of Limits Low or High. Red results means: Outside of critical limits. Rev. A (June 2014) 44 of 118

51 UniCel DxH 800/ DxH 600 Coulter Cellular Analysis System Cellular Inter: Pattern consistent with NRBC detection during a CBC only cycle. This Cellular Interference Suspect message is not associated with a Review (R) flag. Data Fusion saw NRBC cells but no correction of the WBC count. Why???? WBC was not corrected because the NRBC cells were less than 35 fl in size. Rev. A (June 2014) 45 of 118

52 UniCel DxH 800/DxH 600 Coulter Cellular Analysis System Cellular Inter: Pattern consistent with NRBC detection during a CBC only cycle. This Cellular Interference Suspect message is not associated with a Review (R) flag. Data Fusion saw NRBC cells and corrected the WBC count. Why???? WBC was corrected because the NRBC cells were greater than 35 fl in size. Rev. A (June 2014) 46 of 118

53 UniCel DxH 800/DxH 600 Coulter Cellular Analysis System Variant Ly Cellular Inter: Poor separation between a WBC population and interference. WBC correction was performed as a best estimation, and the WBC was flagged with R. Data Fusion saw NRBC and corrected the WBC count. The R flag means review the results. CDR will report NRBC % if enable. That is why no Cellular inter (Suspect Message) obtained. Data Fusion saw NRBC and corrected the WBC count. The R flag means review the results. Rev. A (June 2014) 47 of 118

54 UniCel DxH 800/DxH 600 Coulter Cellular Analysis System WBC was corrected but no Cellular Interference flag was posted. Why???? No suspect message Cellular inter because CDR was ordered. No system message Cellular inter because it was sure of the correction. The DxH 800 technologies: Data Fusion, Watershed, Templating Matching, Shape Signature. An exact match may give you a message, but may not flag the result with an R because it is confident of the correction. Rev. A (June 2014) 48 of 118

55 Additional Data UniCel DxH 800/DxH 600 Coulter Cellular Analysis System : Exception Status 2: Diff Count / Time 3. Flagging Sensitivity Rev. A (June 2014) 49 of 118

56 Additional Data UniCel DxH 800/DxH 600 Coulter Cellular Analysis System : Exception Status 2: Diff Count / Time 3. Flagging Sensitivity Rev. A (June 2014) 50 of 118

57 UniCel DxH 800/DxH 600 Coulter Cellular Analysis System Troubleshooting Procedures Step Cleaning the Specimen Transport Module (STM) 1 Power OFF the SPM. (Specimen Processing Module) 2 Remove any cassettes in the input or output buffer. 3 Remove the Transport Shield. 4 Grasp the front of the STM on both sides; then lift and pull towards you as if opening a drawer. 5 Examine the drip trays behind the mixer and behind the pending buffer. 6 Use a lint-free tissue dampened with DI water to clean the inside of the STM and drip trays, wiping up any spills or buildup. 7 Dry the inside of the STM by wiping with a dry lint-free tissue. Rev. A (June 2014) 51 of 118

58 UniCel DxH 800/DxH 600 Coulter Cellular Analysis System Troubleshooting Procedures Step Cleaning the Optical Sensors 1 Power OFF the SPM. (Specimen Processing Module) 2 Remove the Transport Shield and lift the Front Cover. 3 Locate the optical sensor. Three are located at the input buffer and two at the output buffer. Remember to clean the sensor located at the end of the output buffer. 4 Dampen a very fine lint-free swab with DI water. 5 Swab the optical sensor to remove buildup. 6 Lower the Front Cover and Replace the Transport Shield. 7 Power ON the SPM. Rev. A (June 2014) 52 of 118

59 UniCel DxH 800/DxH 600 Coulter Cellular Analysis System Troubleshooting Procedures Step Cleaning the BSV (Blood Sampling Valve) Externally 1 Power OFF the SPM. (Specimen Processing Module) 2 Remove the Transport Shield. 3 Lift the Front Cover. 4 Locate the BSV. 5 Dampen a piece of lint-free tissue with DI water and wipe down the outside of the BSV. 6 Wipe out the drip tray under the BSV with a lint-free tissue dampened with DI water. 7 Lower the Front Cover. 8 Replace the Transport Shield. 9 Power ON the SPM Rev. A (June 2014) 53 of 118

60 UniCel DxH 800/DxH 600 Coulter Cellular Analysis System Troubleshooting Procedures Step Cleaning the Pneumatic Supply Module (PSM) Fan Filter 1 Power OFF the SPM. (Specimen Processing Module) 2 Unscrew the power / communications cable from the Pneumatic Supply Module (PSM) 3 Locate the filter on the top of the PSM. 4 Using a flathead screwdriver or your hand, loosen the thumbscrews that secure the filter retaining plate and remove the filter from the PSM. 5 Wash the filter with soap and water, rinse and let it dry completely. 6 7 Return the clean air filter and retaining plate to their original location and fasten the thumbscrews to secure the filter. Connect the power / communications cable connector to the power / communication port on the PSM. a. Line up the holes of the connector with the pins in the port. b. Push the connector into the port so that the pins in the port are inserted into the connector. c. Fasten the connector by turning the connector clockwise. 8 Power ON the SPM. Rev. A (June 2014) 54 of 118

61 Step UniCel DxH 800/DxH 600 Coulter Cellular Analysis System Troubleshooting Procedures Cleaning the Air Mix Tempetarure Control (AMTC) Module 1 Power OFF the SPM. (Specimen Processing Module) 2 Remove the Transport Shield. 3 Dampen a lint-free applicator stick with DI water. Note You can use a fabric-tipped applicator to clean the top of the AMTC. Carefully use the tip of the applicator stick to wipe debris away from the port on the AMTC. 4 Note It is important to avoid getting debris in the holes at the top of the AMTC during this procedure. 5 Replace the Transport Shield. 6 Power ON the SPM. Rev. A (June 2014) 55 of 118

62 UniCel DxH 800/DxH 600 Coulter Cellular Analysis System Troubleshooting Procedures Step Cleaning Aperture (Bleaching) Prepare a 20 ml solution of bleach and DI water. Mix together: 1 10 ml of high quality, fragrance-free, gel-free bleach (5 to 6% solution of sodium hypochlorite available chlorine) and 10 ml of DI water. Put 20 ml of DI water in a second container. 2 3 From the System Manager, select Menu > Diagnostics > Dx Tools. 4 Select the Maintenance tab to display the Diagnostic Procedures - Maintenance screen. 5 Select Clean Apertures from the drop-down list. 6 Select Start. The system places the SAM in safe mode and drains the baths. 7 Remove the Transport Shield and lift the Front Cover. 8 Locate the bleach probe. Rev. A (June 2014) 56 of 118

63 When prompted, place the bleach probe into the container of bleach-di water solution. The system aspirates the bleach solution, draws it through the apertures, and then drains the baths. Note that a dialog box displays the Time Elapsed as the aperture bleaching takes place. Note: A maximum of 15 minutes of aperture bleaching is suggested. Select: OK to end the bleaching and continue with the procedure. When prompted, place the bleach probe in DI water (a container of approximately 20 ml of DI water). The system aspirates the DI water. 12 Follow the directions on the screen. 13 Lower the Front Cover and replace the Transport Shield. The system displays System performing Clean CBC Apertures procedure. Please wait. 14 Select Finish Run Shutdown. Note: Do not select the Perform Startup (Daily Checks) after Shutdown check box on the Manual Shutdown dialog box. Refer to the Remove Cleaner section in CHAPTER 8, Shutdown for instructions. Select Cancel from the local navigation bar when you see the timing bar at the lower right-hand side of the screen start to count down. 17 Run Daily Checks. Refer to Run Daily Checks. Rev. A (June 2014) 57 of 118

64 UniCel DxH 800/DxH 600 Coulter Cellular Analysis System Troubleshooting Procedures Step Cleaning the Vacuum Trap 1 Power OFF the SPM (Specimen Processing Module) 2 Locate the vacuum trap. 3 4 Holding the top of the vacuum trap with one hand, use the other hand to unscrew the vacuum trap jar. Empty the vacuum trap jar according to your local environmental regulations and your laboratory s procedures. 5 Rinse the vacuum trap jar with water, and then shake out the excess water. 6 Use a lint-free tissue to dry the vacuum trap jar. 7 8 Dampen a lint-free tissue with DI water and wipe down the black center post inside the vacuum trap assembly. Spin the center post to wipe down the entire surface. Replace the vacuum trap jar. a. Ensure that the black center post is not stuck in the up position. b. Carefully align the threads on the vacuum trap jar with the threads on the vacuum trap assembly and screw the vacuum trap jar into place. 9 Wipe up any spills. 10 Power ON the SPM. Rev. A (June 2014) 58 of 118

65 UniCel DxH 800/DxH 600 Coulter Cellular Analysis System Troubleshooting Procedures Step Cleaning the Aspiration Probe Note Beckman Coulter recommends that you do the Dispense Diluent procedure after cleaning the aspiration probe to verify the integrity of the aspiration path. 1 Select Menu > Diagnostics > Dx Tools > Maintenance tab. 2 Select Clean Aspiration Probe from the drop-down list Select Start. The system: Moves the SAM to a position between the cassette mixer and the AMTC module. Lowers the probe assembly and extends the aspiration probe, exposing it behind the transport shield. Flushes the outside of the aspiration probe with diluent as the probe retracts. If necessary, press (F10) Access System Monitor to view the Probe Waste Vacuum sensor s state on the System Monitor screen. Perform the Dispense Diluent procedure. Refer to the Dispense Diluent Procedure (Menu > Diagnostics > Dx Tools > Maintenance tab) 6 When the procedure is complete, select Finish. Rev. A (June 2014) 59 of 118

66 UniCel DxH 800/DxH 600 Coulter Cellular Analysis System Troubleshooting Procedures Step ZAP Apertures Note This procedure applies voltage across RBC and WBC apertures to remove protein buildup. The system: Drains and rinses the baths. Applies the ZAP voltage across the apertures multiple times. Monitors and displays the ZAP voltages on the System Monitor screen. 1 Select Menu > Diagnostics > Dx Tools > Maintenance tab. 2 Select Zap Apertures from the drop-down list. 3 Select Start to initiate the procedure. 4 Press (F10) Access System Monitor and select Volt/Temp to view the Zap Aperture voltages sensor status on the System Monitor. 5 Select Finish. Rev. A (June 2014) 60 of 118

67 UniCel DxH 800/DxH 600 Coulter Cellular Analysis System Troubleshooting Procedures Step Flush Flow Cell Note The Flush Flow Cell procedure is used to clear blockage or flush debris from the flow cell. The flow cell comprises an upper and lower chamber connected by an aperture. Four procedures are available: The Flush Flow Cell procedure flushes both chambers and flushes the aperture to clear blockage. The Flush Lower Flow Cell procedure flushes the lower chamber only. The Flush Upper Flow Cell procedure flushes the upper chamber only. The Flush Flow Cell with Cleaner procedure flushes both chambers with cleaner. Then, a timer lets you leave the cleaner in the flow cell from 0-30 minutes. After the allowed time has elapsed, the system removes the cleaner from the flow cell and cleans all the areas contacted by the cleaner. If the remove cleaner operation is not successful, the system will not allow any other operation except remove cleaner. 1 Select Menu > Diagnostics > Dx Tools > Maintenance tab. 2 Select Flush Flow Cell from the drop-down list. 3 Select Start to initiate the procedure. 4 Select a procedure and select OK. Note: If you select With Cleaner, a Time in Cleaner text box will be displayed on the Flush Flowcell dialog box. The default time is 5 minutes. Enter your desired time in the cleaner in the text box and select OK. 5 Select Finish. 6 Perform Daily Checks. Rev. A (June 2014) 61 of 118

68 UniCel DxH 800/DxH 600 Coulter Cellular Analysis System Troubleshooting Procedures Step Cycle DV (Distribution Valve) Note The Cycle DV procedure verifies the DV motor, clutch, and optical sensors. The system: Rotates the DV to the right and then to the left 10 times, without moving any liquids. Monitors the DV home and DV segment sensors. Displays the sensors state on the System Monitor screen. 1 Select Menu > Diagnostics > Dx Tools > Maintenance tab. 2 Select Cycle DV from the drop-down list. 3 Select Start to initiate the procedure. 4 Press (F10) Access System Monitor and select SAM to view the sensors s status on the System Monitor SAM/ Blood Transport panel. 5 Select Finish. Rev. A (June 2014) 62 of 118

69 Step UniCel DxH 800/DxH 600 Coulter Cellular Analysis System Troubleshooting Procedure Replace the PSM (Pneumatic Supply Module) 1 Using the handles on the PSM, lift it out of the box. 2 Turn the PSM over so the bottom of the PSM is facing up. On the bottom of the PSM, use a Phillips screw driver to remove the four Phillips-head screws located inside the four socket-head screws, then use the enclosed nut driver to remove the four socket head screws. 3 The PSM ships with feet that are intended for floor cabinet use only. If the DxH is installed on a bench top or non BCI cabinet, the PSM will be placed on the floor or a shelf; you must remove the feet and replace them with the optional feet which are required to support the full weight of the PSM. 4 5 When returning a defective pneumatic supply includes the unused feet and provided tool. Please replace the four socket head screws and Phillips-head screws on the pneumatic supply. Rev. A (June 2014) 63 of 118

70 Rev. A (June 2014) 64 of 118

71 UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System Rev. A (June 2014) 65 of 118

72 UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System System Overview DxH Slidemaker Stainer 2. System Manager 3. Handheld Bar Code Scanner Rev. A (June 2014) 66 of 118

73 UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System System Overview Front Cover 6. Cassette Input Buffer 2. Beacon 7. Power Switch 3.Status Indicators 8. Single-Tube Station 4. Ejector Door 9. Cassette Output Buffer 5. Slide Chute 10. Input/Output (I/O) Drawer Rev. A (June 2014) 67 of 118

74 Left side of the Slidemaker Stainer: 1. Front Cover 2. Input/Output (I/O) Drawer Open/Close Button 3. I/O Drawer UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System System Overview Transport Shield Right side of the Slidemaker Stainer: 1. Front Cover 2. Slide Stack 3.Transport Shield Floor Stand 5. Slide Printer Cover Cartridge Cover 7. Upper Right-Side Cover 4 Rev. A (June 2014) 68 of 118

75 UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System System Overview Optional Floor Stand Deionized Water 7. Cleaner Reagent 2. Supply 4 (S4) 8. Stain Waste 3. Supply 3 (S3) 9. Diluent 1 Container 4. Supply 2 (S2) 10. Diluent 2 Container 5. Supply 1 (S1) 11. Biohazard Waste 1 Container 6. Extra Cleaning 12. Biohazard Waste 2 Container Rev. A (June 2014) 69 of 118

76 UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System Daily Checks Step 1 Select the System Status icon. Look at the SMS screen to give you an overview of basic information about the instrument. Active = online and ready Inactive = offline and not ready Disabled = maker or stainer not available for use Enabled = maker and/or stainer available for use LIS Status: Green = LIS Interface ON Gray = LIS Interface OFF Alert Status Icon color meaning: Red = error Yellow = warning Neutral = OK Displays if unit is Online, Offline, in Diagnostics, or Stopped Printer Status: Status displays Auto Print Disabled, if Disable All Auto Printed Reports is selected from Print >Print Printer Setup 2 Click on the Details Status on the screen. button or double click on the instrument picture Rev. A (June 2014) 70 of 118

77 Step DATE & TIME of last DAILY CHECK and SHUTDOWN Cycles MAKER & STAINER STATUS TRANSPORT STATUS DEFAULT SLIDE ORDER CASSETTE PREPARATION SINGLE-TUBE PREPARATION If the date and time are a neutral color, all is OK. If they are red, there is a problem Look at the Maker and Stainer status for Active, Inactive, or Disabled state. This is where you view the status of the maker and stainer. Transport Status may be Online, if processing samples. Offline, for special cycles and procedures. Diagnostics or Standby, for certain diagnostic tests. Stopped, when system is commanded by the operator to stop the process, or Disconnected, when the system is powered off. Select the Daily Checks alert status icon or Menu>QA>Daily Checks. 6 Select Daily Checks from the local navigation bar. Rev. A (June 2014) 71 of 118

78 Step When the system displays: You have requested to perform Daily Checks. 7 Select OK to run Daily Checks or Select Cancel to go back to the previous screen. 8 This cycle will take approx. 3 minutes. Viewing Daily Checks Information Step 1 Look at the Daily Checks alert status icon. If it is neutral, all is well. If it is red, then something failed and needs review. You can view the daily checks result information for the Summary, SMS, and Supplies. The Daily Checks must pass or be reviewed in order to run specimens. If Daily Checks passes, the Review button is disabled. Note Rev. A (June 2014) 72 of 118

79 Step 2 Select the Review button from the local navigation bar to clear any system failures and to return to neutral. 3 Select the View Log button to review the Daily Checks tab of the History Log. 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. 4 After resolving the cause, repeat Daily Checks. 6 A dialogue window appears asking: Are you sure you want to acknowledge the Daily Checks failure? Press OK to continue. Enable Automatic Daily Checks Step From the Daily Checks screen, select Auto Configuration>Configure Daily Checks to display the Auto Daily Checks Configuration dialog box Rev. A (June 2014) 73 of 118

80 Step Select Enable Automatic Daily Checks to enable running daily checks automatically on your system. Follow the steps to enable/configure automatic Daily Checks You may, select the radio button Perform daily checks after shutdown from the setup screen. If you selected Perform daily checks after shutdown, select OK to save your selection or If you selected Perform daily checks at a specified time, select a time and a day, and select OK to save your selection. Viewing Past Results/Adding Comments Step 1 Select the View Log button from the Local Navigation Bar. 2 You may select one date at a time to review. Rev. A (June 2014) 74 of 118

81 Step 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. 3 With any date highlighted, select the Comments button below to add a comment. 4 Rev. A (June 2014) 75 of 118

82 Step 5 Select OK to save comment. 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. 6 Printing/Auto-Printing Step 1 You may manually print individual results by selecting the print icon from the utility area at the upper right. On the daily checks screen, you may print the Daily Checks Auto Report. If you are on Daily Checks: View Log>Log Type>Data Summary Logs, you may print: Entire log, All filtered, or Selected entries by clicking the print icon from the utility area at the upper right. 2 Rev. A (June 2014) 76 of 118

83 Step 3 You may decide to have the Daily Checks print automatically. 4 To do this, return to the Daily Checks screen by selecting the Daily Checks icon. 5 Select the Auto Report button from the Local Navigation bar. This opens the Daily Checks Auto Report window. You may select to print automatically by checking the Enable auto report generation box. 6 Rev. A (June 2014) 77 of 118

84 UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System Samples Processing Cassette Presentation (LIS Bidirectional Download to Pending) Step 1 Place the instrument online. The instrument will automatically begin cycling the cassettes. 2 Ensure your specimens have been collected and stored properly. Load the specimens into the cassette. 3 Place the cassettes into the input buffer and slide the cassette forward until the green light is on. 4 Rev. A (June 2014) 78 of 118

85 Single Tube Presentation Step 1 Select the Single-tube Presentation icon. The single-tube Presentation Dialog Box will come up. 2 3 Place the specimen in the grooved area in front of the barcode reader or Enter the Sample ID manually (You may use alpha or numeric characters) or Use the bar-code scanner to scan the label. Your handheld bar-code scanner is a camera that takes a picture of the bar-code. Note: Move the label closer if the bar-code scanner does not read the information. Once the bar-code is read, you will hear a beep. 4 Press Enter. 5 6 Place the tube in the correct cradle position. The left (lavender) position adapts to both open and closed vial tubes from 12 to 13 mm in diameter. The right (green) position holds microtainer tubes. The cradle retracts and the instrument processes the specimen. When the instrument is ready to process the next specimen, the system sends the cradle back out again. Select the Exit button on the Single-Tube Station dialog box to exit from the Single-Tube Station when sample processing is complete. Rev. A (June 2014) 79 of 118

86 Adding a Test Order (Menu>Worklist) Step 1 2 Select Single-tube Presentation Icon or Select Menu>Worklist. Select the Slides tab, Pending for the Filter Name, and Add Order button from the local navigation bar or Select the Slides tab and select the Add Order button from the local navigation bar. On the Add Order screen, enter the specimen ID manually or by using the barcode scanner. 3 4 Select the desired radio buttons for Make, or Make and Stain. 5 6 Select the number of slides to be made, and/or made and staining using +/- buttons or editing the default value of 1. If desired, select the Patient button and Add Patient from the local navigation bar to add patient demographics. 7 Enter patient information and select OK. 8 Select the Submit button from the local navigation bar. Rev. A (June 2014) 80 of 118

87 View Basket Details Step 1 Select to display the System Status screen. 2 Select the Details Status from the local navigation bar. Select Basket Management from the local navigation bar to view the Basket Management screen. On this screen, you can manage baskets or get basket information anywhere in the Stainer module and Basket Transport Module. 3 Select Basket Details from the local navigation bar to display the Basket Details dialog box containing specific patient information for the slides in the selected location. 4 5 View the details and select OK when you are done or Select Cancel to exit the screen. Rev. A (June 2014) 81 of 118

88 Advance Baskets Follow these steps to advance a selected basket to the I/O drawer. Step 1 Select to display the System Status screen. 2 Select the Details Status from the local navigation bar on the DxH Slidemaker Stainer Status screen or double click on the instrument icon. Select Basket Management from the local navigation bar to view the Basket Management screen. 3 4 Select the basket to advance. 5 Select Advance Basket from the local navigation bar to display the Basket Details dialog box. Note: The baskets/slides may be wet if you select Advance Basket before the pre-stain drying cycle is complete. On the DxH Solutions dialog box, select OK to forward the basket to the I/O drawer. 6 Rev. A (June 2014) 82 of 118

89 Select Basket to Stain Next Follow these steps to schedule the next basket with slides for staining. Step 1 Select to display the System Status screen. 2 Select the Details Status from the local navigation bar. Select Basket Management from the local navigation bar to view the Basket Management screen. 3 4 Select the basket to stain next. Select Stain Next from the local navigation bar to display the Stain Next dialog box. 5 6 Select OK to save you changes or Select Cancel to go back to the previous screen. Rev. A (June 2014) 83 of 118

90 Cancel Staining This command cancels all staining in progress and all slides waiting to be stained. Slides that are in the stainer will advance to the dryer and then to the I/O drawer. Slides in the basket elevator will advance to the I/O drawer. Step 1 Select to display the System Status screen. 2 Select the Details Status from the local navigation bar. Select Basket Management from the local navigation bar to view the Basket Management screen. 3 Select Cancel Staining from the local navigation bar to display the Cancel Staining dialog box. 4 5 Select OK to save your changes or Select Cancel to go back to the previous screen. Rev. A (June 2014) 84 of 118

91 Loading or Removing Baskets at the Input/Output (I/O) Drawer Risk of personal injury and contamination. The processing areas may contain prepared smears and/or broken glass with biohazardous material. Handle with care and avoid skin contact. Risk of personal injury and contamination. The instrument could continue to move or could have delayed movement. Wait a few seconds to ensure that all movement has ended before pulling the I/O drawer. Step Press the round lighted button to access the input/output (I/O) drawer. 1 Once the drawer has stopped moving (it may take a few seconds), pull the handle towards you until it clicks. 2 3 Remove and/or load the baskets. The indicator lights are: Blinking green when the basket is ready for you to remove it Steady green when the basket is ready to be used by the system Blinking red when the basket is in an error state Blinking blue when a basket is loaded with slides for staining only Push the handle toward the instrument until it stops. The drawer will automatically return to its position inside the instrument. 4 Rev. A (June 2014) 85 of 118

92 Staining Samples Manually (Stain-Only Priority) Risk of personal injury and contamination. The processing areas could contain prepared smears and/or broken glass with biohazardous material. Handle with care and avoid skin contact. Some samples may require manual staining, such as small blood draws (pediatric) taken with microcollection devices. Follow these steps to manually stain a sample. Step Fill in an empty basket with slides ready to stain (painted end on top so as not to stain the sample information). 1 Place the basket back in the I/O drawer in any open/empty position from 1 to 6. 2 Press the number where the basket is placed. 3 Push the drawer in for staining to begin. 4 Rev. A (June 2014) 86 of 118

93 Making Slides (No Staining) Risk of injury and biohazardous contamination. Clean up any broken glass or blood spill as quickly as possible. Handle with care. Avoid skin puncture. Dispose of all contaminated disposable cleaning materials and broken slides in accordance with your local regulations and acceptable laboratory practices. Risk of contamination. The prepared smears contain biohazardous materials. Handle with care and avoid skin contact. Follow these steps to make slides that do not require staining: Step 1 Select Make Slide on the Default Test Order for the applicable cassette or singletube presentation or Add or edit a test from the Worklist Pending tab or Load samples for the processing of downloaded Test Orders from the LIS. Rev. A (June 2014) 87 of 118

94 UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System Shutdown The DxH Slidemaker Stainer allows you to program the length of time the instrument is in Shutdown. The default time is 30 minutes. This is the minimum time required for Shutdown. 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 1 From the Daily Checks screen, select the Shutdown button to display the Manual shutdown dialog box Select the Perform Daily Checks After Shutdown check box to automatically begin Daily Checks after shutdown is completed. Type a number in the Time in Cleaner Hours and Minutes check boxes to determine the time in cleaner. Note: No other cycles or System Manager actions can be performed until the Shutdown cycle has completed. Once the Shutdown cycle is complete, a countdown timer bar appears at the bottom of the Daily checks screen to let you know how much time remains for the cleaning. 5 Select OK to begin shutdown or Cancel to exit. Rev. A (June 2014) 88 of 118

95 Enable Automatic Shutdown Step From the Daily Checks screen, select Auto Configuration>Configure Shutdown to display the Auto Shutdown Configuration dialog box. Select Enable Automatic Shutdown to enable running Shutdown automatically on your system. In your Laboratory you may set-up shutdown as follows: Type the time for automatic shutdown in Hour and Minutes in the text box. Select Daily or select specific days of the week to run Shutdown automatically. Type the time the cleaner should remain in the DxH Slidemaker Stainer during the shutdown procedure in Hours and Minutes. 4 Select OK to save your selections. Rev. A (June 2014) 89 of 118

96 UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System Supplies For any non-beckman Coulter reagent, select Setup Other and manually enter the bar code information. You can enter up to five supplies. Step 1 Select to display the Supplies screen. or Select Menu>Supplies>Slidemaker tab. On the Supplies screen, select the Setup button from the local navigation bar. 2 Rev. A (June 2014) 90 of 118

97 Step On the Setup Supplies dialog box, scan or manually enter the bar codes into Bar Code fields 1 and 2, and select OK. Note: The fields on the Supplies screen are automatically populated from the bar code information. The percent (%) remaining of each supply appears on the bottle graphics. From the Supply drop-down list, choose Diluent 1 or Diluent 2 to be replaced and select OK. After entering the information, the system fills in the reagent type, lot number, and other information on the left side under Supply Information Preview. Select OK to verify the reagent has been replaced or Select Cancel to go back to the previous screen. 6 Repeat steps 1 to 5 above for each remaining supply. Configure Low-Level Notification Step 1 Select or Menu>Supplies Note From either the Slidemaker or Stainer tab, select the Config Low Level button from the local navigation bar on the Supplies screen. Note: You must configure the low-level notification for reagents for both the Slidemaker and Stainer tabs. On the Configure Low Level Condition screen, select a low-level percentage from the drop-down box (default is 10%). Select OK to save your changes or Select Cancel to go back to the previous screen. You may set the low-level warning from 5% to 15%. When this occurs, the Supplies Alert Status Icon is yellow. If a supply is out, the icon is red. Rev. A (June 2014) 91 of 118

98 Setting Up Beckman Coulter Stainer Reagents For any non-beckman Coulter reagent, select Setup Other and manually enter the bar code information. You can enter up to five supplies. Follow these steps to set up reagents for the stainer. Step 1 Select to display the Supplies screen. or Select Menu>Supplies>Stainer tab. On the Supplies screen, select the Setup button from the local navigation bar. 2 Rev. A (June 2014) 92 of 118

99 Step Scan or manually enter the barcodes, into Bar Code fields 1 and 2, and select OK. 3 4 On the Supply field, choose the reagent to be replaced from the drop-down list. 5 On the displayed message, select OK to verify that the reagent has been replaced or Select Cancel to go back to the previous screen. 6 You would repeat steps 3 to 5 above for each remaining supply. Select Details from the local navigation bar to display information for each supply. Note: Slidestainer Supplies Details indicates the supplies required for the active staining protocol set for the instrument. 7 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. Supplies Data Summary Log: This log records all the information on each new container set up on the System. Rev. A (June 2014) 93 of 118

100 UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System Loading Slides The software supply icon turns yellow when the slide level is low. The software supply icon will turn red when the slides are completely out. The system will go offline until more slides are loaded. Go back online to continue processing the slides. Risk of injury and biohazardous contamination. Handle slides with care to avoid skin puncture. Clean up any broken glass or blood spill as quickly as possible. Dispose of all contaminated disposable cleaning materials and broken slides in accordance with your local regulations and acceptable laboratory practices. NOTE: There are 2 sensors on the slide chute. One of the sensors, checks the slide inventory below ½ (approx 75 slides). When this happens the Supplies Icon will be in Yellow. The other sensor will stop the Slidemaker Stainer. This will occur when there are 12 slides left in the chute. The Supplies Icon will be in red. Step Open the slide ejector door. 1 Remove slides from the box handling them by the painted end. 2 Rev. A (June 2014) 94 of 118

101 Step Load the slides into the slide chute with the painted side up and to the right. 3 Note: You can load up to 172 slides. Be aware that slides exposed to high humidity may stick together. Close the slide ejector door. 4 Rev. A (June 2014) 95 of 118

102 UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System Disabling/Enabling Disable the Stainer Step 1 Select to display the System Status screen. 2 Select Details Status. 3 Select Module>Disable Stainer from the local navigation bar. 4 5 On the Disable Module dialog box, select the checkbox and select OK to disable the stainer. Select YES when the system displays: You have requested to temporarily disable a module. Do you want to continue with the request? Enable the Stainer Step 1 Select to display the System Status screen. 2 Select Details Status. 3 Select Module>Disable Stainer from the local navigation bar. 4 5 On the Disable Module dialog box, deselect the check box and select OK to enable the stainer. Select YES when the system displays: You have selected to enable a module. The System will automatically perform a Prime. Performance verification must be performed before patient samples can me analyzed. Do you want to Continue? Rev. A (June 2014) 96 of 118

103 UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System Disabling/Enabling Disable the Maker Step 1 Select to display the System Status screen. 2 Select Details Status. 3 Select Module>Disable Maker from the local navigation bar. 4 5 On the Disable Module dialog box, select the check box and select OK to disable the maker. Select YES when the system displays: You have requested to temporarily disable a module. Do you want to continue with the request? Enable the Maker Step 1 Select to display the System Status screen. 2 Select Details Status. 3 Select Module>Disable Maker from the local navigation bar. 4 5 On the Disable Module dialog box, deselect the check box and select OK to enable the maker. Select YES when the system displays: You have selected to enable a module. The System will automatically perform a Prime. Performance verification must be performed before patient samples can me analyzed. Do you want to Continue? Rev. A (June 2014) 97 of 118

104 UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System Enabling/Disabling Batching Step Note The system must be offline and no staining should be in progress in order to perform this procedure. You can use batching when you want to analyze all your specimens with the same default test panel (for example, when the LIS is down). 1 Select to display the System Status screen. 2 Select the Details Status from the local navigation bar. 3 Select the Batching from the local navigation bar. Select the checkbox to enable Batching or deselect the checkbox to disable Batching. 4 Note All results are labeled as Default Slide Order. 5 Select OK. Rev. A (June 2014) 98 of 118

105 UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System Configure Auto Stop Settings Step 1 Select System Status>More. 2 Select Auto Stop from the local navigation bar. On the Configure Auto Stop Settings dialog box, select from the following options: 3 4 Select OK to confirm your selection or Select Cancel to go back to the previous screen. Rev. A (June 2014) 99 of 118

106 UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System Cleaning Procedure 1. Drain ALL Baths. 2. Transfer pickup tubes of supplies 2 and 4 to the Methanol cleaning bottles. Wrap pickup tubes assembly in clean gauze to prevent dripping. 3. Individually fill baths (2 and 3) with Methanol. 4. Allow the Methanol to sit in the baths for at least 15 minutes. 5. Drain baths (2 and 3) individually or you may select Drain All Baths. 6. Remove pick tubes assembly from the Methanol cleaning bottles and turn them upside-down. Wrap pickup tubes assembly in clean gauze to prevent dripping. 7. While holding pickup tubes individually fill baths (2 and 3) with air. Allow air to flow thru pickup tubes for less then 2 minutes and press Cancel. (This will prevent the low supply warning). 8. Transfer pickup tubes assembly back into supplies (2 and 4). 9. Select the Finish icon from the Local Navigation Bar. 10. Clean or Replace baths, especially baths (2 and 3). 11. Clean the probes by wiping them with Methanol. 12. Place the DxH Slidemaker Stainer Online to Continue Working. Rev. A (June 2014) 100 of 118

107 UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System System Components (Front Side) Aspiration Probe Hemasphere Blood Detector Dispense Probe Slide Chute Bar Code Reader Printer Ribbon Printer Head Stain Drawer I/O Drawer Output Buffer Mix Stations Smear Shuttle Single Tube Presentation Bar Code Reader Input Buffer Rev. A (June 2014) 101 of 118

108 UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System System Components (Right Side) Basket Elevator Rear Printer Ribbon Basket Elevator Front Print Head Print Shuttle Ribbon Drive Motor Smear Shuttle Motor Slide Printer Print Head Printer Ribbon Print Shuttle Ribbon Drive Motor Rev. A (June 2014) 102 of 118

109 UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System System Components (Left Side) Input/Output (I/O) Drawer Button (I/O) Drawer Aspiration Probe Dispense Probe Overflow Chamber Output Buffer Rev. A (June 2014) 103 of 118

110 UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System System Components (Slide Stainer) Hemasphere Blood Detector Lee Valve Aspiration Probe Dispense Probe Fill Probe Bar Code Reader Over Flow Sensor Stain Drawer Bath Drain Probe (Tube) Bath Tray Access Handle Rev. A (June 2014) 104 of 118

111 Basket Management To view the Basket Management information, the operator selects Basket Management from the local navigation bar. On this screen, you can manage baskets or get basket information anywhere in the Stainer module and I/O drawer. An example of this is the Basket that has been selected by the operator on this screen capture. When a basket is selected, it will have a lime green halo around it. The operator may refer to the Basket Data box, where the following information may be found. Type = Make and Stain or Stain Only. State = refers to what is happening to the slide at this moment. Priority = Routine, STAT, ASAP. Duration Time = based on the stain protocol settings, refers to how long the slide is programmed to be in that specific location. (ie: staining bath, elevator, dryer). In this example, its is Bath 2. Elapsed Time = refers to the amount of time the slide has already been in that specific location. Remaining Time = refers to the amount of time remaining in that location. (ie: staining bath, elevator, dryer) ETC = refers to Estimated Time to Complete Rev. A (June 2014) 105 of 118

112 Loading/Removing Baskets Input/Output (I/O) Drawer The indicator lights in the I/O drawer mean the following: Blinking Green when the basket is ready for you to remove it Steady Green when the basket is ready to be used by the system Blinking Red when the basket is in an error state Blinking Blue when a basket is loaded with slides for staining only Rev. A (June 2014) 106 of 118

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115 UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEMS Task Resource How Measured? IDENTIFY POTENTIAL HAZARDS AND SAFETY FEATURES Review MSDS m MSDS manual in lab Direct Observation Recognize Hazard Symbols System HELP Direct Observation IDENTIFY AND BRIEFLY EXPLAIN FUNCTION OF ANALYZER COMPONENTS OVERVIEW OF SCREENS AND SOFTWARE Identify System Manager Icons and Screens MANAGE REAGENTS AND CONSUMABLES Setup new lot number for Reagents and Stains System HELP System HELP Training Material Direct Observation Direct Observation Use System HELP Direct Observation System HELP Training Material Direct Observation Replace reagent container Direct Observation Loading Slides Direct Observation DAILY CHECKS AND SHUTDOWN PROCEDURES Perform a Daily Checks Cycle & Review the Results System HELP Training Material Direct Observation Perform a Shutdown Direct Observation Achieved? N/ Y N A Date Trainee Initial Trainer Initial Rev. A (June 2014) 109 of 118

116 UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEMS Task Resource How Measured? SETTING UP THE SLIDEMAKER System HELP Training Material Direct Observation Setting up Default Slide Order/Set Number Direct Observation of Slides Setting up Basket Settings Direct Observation Set Pre-Stain Drying Type Direct Observation Configure the Slide Label Direct Observation Set up Smear Settings Direct Observation SETTING UP THE STAINER System HELP Training Material Laboratory Protocol Set Active Staining Protocol Direct Observation Add/Edit a Staining Protocol Direct Observation Configure Baths (mapping) to the Bath Direct Observation Location Copy Staining Protocol Direct Observation Delete Staining Protocol Direct Observation Achieved? N/ Y N A Date Trainee Initial Trainer Initial Rev. A (June 2014) 110 of 118

117 UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEMS Task Resource How Measured? Setting up a Quick Rinse Direct Observation DISABLING/ENABLING THE SLIDEMAKER System HELP STAINER Training Material Disable the Slidemaker Direct Observation Enable the Slidemaker Direct Observation Disable the Stainer Direct Observation SAMPLE PROCESSING Replace the Hand-held Bar-Code Scanner Direct Observation IFU System HELP Training Material Laboratory Protocol State the Aspiration Volume Direct Observation Process a Bar Coded Sample (Cassette Presentation) Process a Bar Coded Sample (Single Tube Presentation) Process a Sample in a microtainer using Single tube Presentation Direct Observation Direct Observation Process a STAT Direct Observation Direct Observation Achieved? N/ Y N A Date Trainee Initial Trainer Initial Rev. A (June 2014) 111 of 118

118 UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEMS Task Resource How Measured? TROUBLESHOOTING IFU System HELP Training Material Removing System Covers Direct Observation Components and Sample Flow Direct Observation Replacement Procedures Direct Observation Cleaning Procedures Direct Observation Using Diagnostics Direct Observation Optimizing Stain Protocols Smear Quality and Stain Quality ADDITIONAL TOPICS Direct Observation IFU System HELP Training Material History Logs Direct Observation Operator and Rules Direct Observation Configure Auto Stop Settings Direct Observation Enabling Batching Direct Observation Achieved? N/ Y N A Date Trainee Initial Trainer Initial Rev. A (June 2014) 112 of 118

119 UniCel DxH SlideMaker Examples of Stain Protocols 1. Protocol Options (Customer) Wright Giemsa with Quick Rinse Stain Protocol Bath Supply Type % Duration 1 Methanol 100% 25 seconds 2 Stain 100% 2 minutes 3 Buffer/Stain Buffer 83%, Stain 17% 3 min, 15 seconds 4 Quick Rinse Water 75%, Methanol 25% 6 seconds 5 Water 100% 2 minutes Auto drain and refill for bath 4 every 15 baskets Auto drain and refill for bath 5 every 10 baskets Drying Duration: 2 minutes SMS Configuration>Basket Settings 1. Distribution: Every other position: Stat Timeout: 5 minutes 3. ASAP Timeout: 8 minutes 4. Routine Timeout: 10 minutes 5. Pre-Staining Drying Time: 6 minute 2. Protocol Options (Customer) Wright Giemsa with Quick Rinse Stain Protocol Bath Supply Type % Duration 1 Methanol 100% 25 seconds 2 Stain 100% 3 minutes 3 Buffer/Stain Buffer 90%, Stain 10% 3 minutes 4 Quick Rinse Water 75%, Methanol 25% 25 seconds 5 Water 100% 2 min, 30 seconds Auto drain and refill for bath 4 every 15 baskets Auto drain and refill for bath 5 every 10 baskets Drying Duration 3 minutes SMS Configuration>Basket Settings 1. Distribution: Every other position: Stat Timeout: 10 minutes 3. ASAP Timeout: 10 minutes 4. Routine Timeout: 10 minutes 5. Pre-Staining Drying Time: 6 minutes Rev. A (June 2014) 113 of 118

120 3. Protocol Options (Customer) Wright Stain Protocol Bath Supply Type % Duration 1 Methanol 100% 30 seconds 2 Stain 100% 1 min, 15 seconds 3 Buffer/Stain Buffer 95%, Stain 5% 2 minutes 4 Quick Rinse N/A N/A 5 Water 100% 1 minutes Auto drain and refill for bath 5 every 10 baskets Drying Duration: 2 minutes SMS Configuration>Basket Settings 1. Distribution: Every other position: Stat Timeout: 10 minutes 3. ASAP Timeout: 10 minutes 4. Routine Timeout: 10 minutes 5. Pre-Staining Drying Time: 6minutes 4. Protocol Options (Customer) Wright Giemsa with Quick Rinse Stain Protocol Bath Supply Type % Duration 1 Methanol 100% 35 seconds 2 Stain 100% 1 min, 20 seconds 3 Buffer/Stain Buffer 90%, Stain 10% 2 min, 10 seconds 4 Quick Rinse Water 75%, Methanol 25% 10 seconds 5 Water 100% 1 minutes Auto drain and refill for bath 5 every 10 baskets Drying Duration: 3 minutes SMS Configuration>Basket Settings 1. Distribution: Every other position: Stat Timeout: 8 minutes 3. ASAP Timeout: 10 minutes 4. Routine Timeout: 10 minutes 5. Pre-Staining Drying Time: 6 minutes Rev. A (June 2014) 114 of 118

121 Beckman Coulter Website Training & Education (Accessing the Training Materials on the Web) Step 1 Go to If promted click on Americas, then click on the United States Double click on Diagnostics. 2 Click on Training & Education. 3 Rev. A (June 2014) 115 of 118

122 Step Click on Hematology. 4 Click on the Hematology product you want to view. 5 ie: UniCel DxH 800. UniCel DxH Slidemaker Stainer, LH 750, LH When you open the file to the product you will find 4 tabs: Tools& Aids = This tab provides you with the training materials used for Customer Operator Training. On Demand = This tab provides you with different training solutions offering 24/7 access. (You must create an account to receive PACE and or a Florida CE Broker certificates). Webinars& Conferences = This tab provides web based learning conferences and Virtual Symposia. Instructor Lead = This tab provides information regarding the training curriculum. Rev. A (June 2014) 116 of 118