Unicel DxH 600 System

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1 SETUP MODULES Setup Unicel DxH 600 System Troubleshooting System Overview Additional Topics This document is not intended to replace the information in your Instrument Instructions for Use Manual (IFU). Information in the Instructions for Use Manual supersedes information in any other manual. PN: A62452A (June 2013) S-1 of 48 Beckman Coulter Professional Development

2 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 S-2 of 48 Beckman Coulter Professional Development PN: A62452A (March 2013)

3 COURSE MAP SETUP Begin Here Operator and Roles Control Files Calibration Flagging Limits Decision Rules PN: A62452A (June 2013) S-3 of 48 Beckman Coulter Professional Development

4 PERSONAL PROGRESS SUMMARY Name Setup Modules Date Initial Facilitator Operators and Roles Control Files Calibration Flagging Limits Decision Rules S-4 of 48 Beckman Coulter Professional Development PN: A62452A (March 2013)

5 OBJECTIVES OPERATORS AND ROLES Given an operating DxH 600 System and access to System HELP Create new operator logins for a Level I, Level II and Level III access Edit an existing operator account Reset an operator password Change your own password Set a Password Expiration and enable Auto Lockout (optional) Why Is It Important? As a DxH 600 System operator with Level III (highest customer) privileges, you will help decide the levels of security access for those working with you, based on their laboratory responsibilities. Resources DxH 600 System PN: A62452A (June 2013) S-5 of 48 Beckman Coulter Professional Development

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7 INFORMATION/PRACTICE The Lab Administrator can assign operator roles and access level from the Operators and Roles screen. During the classroom exercises, you are at a Level III access. These next steps will show you how to manage and create the other two customer levels. Read Operators and Roles HELP topic in Chapter 9 for reference. Add a New Operator In System HELP, go to Appendix B and expand Operator Access. There are thirteen tables that list the various operator functions by Level I, II and III. Step Action Go to Menu>Setup>Operators and Roles>New Operator to display the New Operator dialog box. 1 Enter the appropriate information in the text boxes. 2 TIP 1 TIP 2 Follow the steps shown and create a new Level III login for yourself as well as a Level I and a Level II login. You may be creative with your entries! Note that the Level III access (aka Lab Administrator) is the only one of the levels that can set up or edit other operator levels. Ultimately, the Operator ID and Password will be the information entered on the login screen. Remember that BOTH are case-sensitive. The initial password entered at this point is considered a temporary password. Simply use the word temp for now. Write down the information you enter for each level below: PN: A62452A (June 2013) S-7 of 48 Beckman Coulter Professional Development

8 L I L II L III 4 First Name Last Name Operator ID Password temp Confirm Password _temp First Name Last Name Operator ID Password temp Confirm Password _temp First Name Last Name Operator ID Password temp Confirm Password _temp The Account Status defaults to Active. 5 Select OK to create the new operator. Log on at Your New Levels Step 1 2 Action At the Log on screen, type in your new Level I Operator ID and the Password temp. A message appears telling you that the password is a temporary one and to enter a new password. Select OK. 3 Type in temp for the old password. 4 Type in the new password you want to use. You will need to do this for Password and Confirm Password. 5 Record your password for Level I here 6 Explore the different screen areas noting the differences (for example, the areas to which you no longer have access). S-8 of 48 Beckman Coulter Professional Development PN: A62452A (March 2013)

9 7 Once you complete steps 1-6 above, select Log off 8 Now repeat steps 1-7 for the Level II log on. 9 Record your password for Level II here 10 Now repeat steps 1-7 for the Level III log on. 11 Record your password for Level III here Edit an Existing Operator You must be logged in at Level III access to perform this exercise. One reason for needing to perform this editing is to change an existing operator s access, e.g. from Level I to Level II. Read Edit an Existing Operator HELP topic in Chapter 9 for reference. Step Action 1 Log on as a Level III (Lab Administrator user). 2 Go to Menu>Setup>Operators and Roles>Edit Operator. You may make changes to the First Name, Last Name, Access Level, and Account Status. 3 4 Follow the steps and choose the Level II account you previously set up. Change it to Level I and make it Inactive. Note that you may also edit the first and last name. 5 Select OK to save the changes. PN: A62452A (June 2013) S-9 of 48 Beckman Coulter Professional Development

10 Reset an Operator s Password The Level III Operator may reset the password of another operator. This may be necessary if operators forget their own password. Read Reset an Operator s Password HELP topic in Chapter 9 for reference. Step Action 1 Log on as a Level III (Lab Administrator). 2 Go to Menu>Setup>Operators and Roles>Reset Password. 3 Select the Level I Operator ID you previously set up. 4 Type the operator s New Password and type it again in the Confirm Password text box. Note: Passwords must be alphanumeric and 3-9 characters in length. 5 Select OK to save the changes. 6 Log off and Log on to try it out. Change Your Password Any operator may change his or her own password at any time. Select the Change Password button from the Operators and Roles screen. Try this now and change back to your original password for Level I. Set Timeout Settings A Lab Administrator (Level III) The Password Expiration defaults to 60 days. You may change this to 30 days or 90 days or Disable it. The Auto-Lockout feature is initially disabled. You may enable it and set the number of minutes between 5 and 60. This is the amount of time of non-use that requires the user to log in again. You reached the goal! Please continue to the Skill Check on the next page. S-10 of 48 Beckman Coulter Professional Development PN: A62452A (March 2013)

11 OPERATORS AND ROLES SKILL CHECK 1. Show facilitator the three access levels you created. 2. Demonstrate editing an account. 3. Demonstrate resetting a password. 4. Demonstrate changing your own password. PN: A62452A (June 2013) S-11 of 48 Beckman Coulter Professional Development

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13 OBJECTIVES CONTROL FILES Using the System HELP: Access the screens to set up new control files Set up COULTER LATRON CP-X Control Set up COULTER 6C Cell Control Set up COULTER Retic-X Cell Control (Optional) Set up COULTER Body Fluid Control (Optional) Access options for Auto Transmit, Auto Stop and Auto Print Change the Control State of a Control Why Is It Important? Proper and timely set up of controls is the basis of a good laboratory Quality control program Resources DxH 600 System System HELP Package inserts containing 2D bar-coded information for Latron CP-X, 6C Cell Control, Retic-X Cell Control, Body Fluid Control. PN: A62452A (June 2013) S-13 of 48 Beckman Coulter Professional Development

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15 INFORMATION/PRACTICE New Beckman Coulter Control from Bar Code Read Quality Control (Commercial Controls) HELP topic in Chapter 9 for reference. Step Action 1 Obtain bar-coded inserts from the facilitator and follow the procedure to setup each of the controls in the System Manager. 2 Go to Menu>Setup>Quality Control>New Control from Barcode Scan the control barcodes using the handheld barcode scanner. 3 4 You may select to: Auto Transmit, if you want your control results to transmit to an LIS QC package as well as to the System Manager files. Auto Stop, if you want the system to stop when a control run has a parameter out of range. It is not necessary to select this option if you run your controls separately from your patient specimens. However, if you do run controls and specimens together, then this option may be useful to you. Auto Print, if you want a hard copy of each individual control run. Most labs no longer use this as they are trying to go paperless. If you forget to enable any of these features and decide to use them, you can open each control file by selecting the Edit Control button and enabling. 5 Select OK to accept. PN: A62452A (June 2013) S-15 of 48 Beckman Coulter Professional Development

16 Auto Configuring Beckman Coulter Controls You can set up the SPM to automatically configure the Beckman Coulter Controls. The Auto Configure option will automatically set up a control file for a control that is presented to the system, where a control file is NOT present. That control file does not contain assigned values or expected ranges; these can be configured at a later date. Changing a Control State Step Action Control files have filters that let you select a Control State. These filters are as follows: Active is the default state. Active control files are currently in use. Active control files are evaluated and stored. Event log messages, alarms and stop conditions are triggered as applicable. Accumulating controls files are used during crossover studies. Accumulating control files will not trigger event log messages, alarms and stop conditions. Processing is otherwise the same as the Active State. Inactive control lots are no longer in use. No new data will be added to a file in an Inactive state For classroom practice, let us change the control state of a control file you set up. Go to Menu>Setup>Quality Control. Select one of the control files you set up in the previous exercise. Select More Options from the local navigation bar, then Change State. Change the state of this control file to Accumulating. Note: By default, the system will put all control files set up in Active State. 4 Choose another control file and change the state to Inactive. Note The following control files cannot have the same lot numbers: Two active files Two accumulating files An active and an accumulating file S-16 of 48 Beckman Coulter Professional Development PN: A62452A (March 2013)

17 It is possible for the following to have the same lot number: An inactive and accumulating file An inactive and active file Different inactive files Auto Print Setup Histograms and data plots can be displayed on individual control runs that are auto-printed. Read Quality Control (Auto Print Setup) HELP topic in Chapter 9 for reference. Step Action From the Quality Control Setup Controls screen, select the Auto Print Setup to display the Auto Print Setup dialog box. (Automatic printing of control file results themselves must be configured inside the individual control file setup.) Select the Histograms checkbox to automatically print QC histogram results. Select the Dataplots checkbox to automatically print QC dataplots results. 4 Select OK to save the selected auto print settings. PN: A62452A (June 2013) S-17 of 48 Beckman Coulter Professional Development

18 QC History Log When a control is out of range and/or triggers an Auto Stop, an entry goes into the Event Log for QC. You may add comments to the entry to catalog the actions taken. There is an option to copy it to the maintenance log as well. Go to the QC log, add a comment and check the option for the maintenance log. You reached the goal! Please continue to the Skill Check on the next page. S-18 of 48 Beckman Coulter Professional Development PN: A62452A (March 2013)

19 CONTROL FILES SKILL CHECK 1. Show the facilitator the control files that you set up. 2. Define: Auto Transmit Auto Stop 3. Define the 3 control filters: Active Inactive Accumulating 4. Show facilitator the comment you added to a control in the QC log and maintenance log. 5. Show facilitator the control files you changed states. PN: A62452A (June 2013) S-19 of 48 Beckman Coulter Professional Development

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21 OBJECTIVES CALIBRATION Given an operating DxH 600 System and using the System HELP Perform the calibration procedure using the COULTER S-CAL Calibrator Kit Adjust calibration factors as required by the calibration results State when you should calibrate your instrument State when you should verify the calibration of your instrument Why Is It Important? Calibration fine-tunes the DxH 600 System to give you the most accurate results possible. Calibration is one part of verifying the accuracy of your instrument in conjunction with your historical QC and knowing the service history of your instrument. Resources DxH 600 System System HELP S-CAL Calibrator PN: A62452A (June 2013) S-21 of 48 Beckman Coulter Professional Development

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23 INFORMATION/PRACTICE Ask your facilitator for a tube of S-CAL Calibrator and the bar-coded insert sheet before you begin. The calibrator should remain at room temperature for 15 minutes before mixing and using. Please review the calibrator preparation/mixing directions on the insert sheet before proceeding. However, please follow the procedure Calibration in Chapter 11 of HELP. 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 10º F or 12º C from the calibrating temperature. If the procedure indicates you need to calibrate, continue with the calibration procedure. PN: A62452A (June 2013) S-23 of 48 Beckman Coulter Professional Development

24 Calibration Procedure Step Note Action Before you can start or restart the calibration process, the SPM must be offline. Select Menu>QA>CBC Calibration 1 Select Calibration Setup on the CBC Calibration Screen to display the CBC Calibration Setup dialog box. 2 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 barcode scanner to scan the 2D bar code on the product insert or enter/select the following information: Lot# Expiration Date Reference Values 7 Select OK and follow the screen prompts. S-24 of 48 Beckman Coulter Professional Development PN: A62452A (March 2013)

25 8 Place the calibrator in a cassette and place it in the input buffer. 9 Select OK 10 Review the calibration results. If your calibration runs do not indicate the need for any changes, please notify the facilitator before proceeding!! 11 Select the Finish button at the bottom of the screen. 12 Verify your calibration with controls. Do not perform this in class, but do so in your lab! You reached the goal! Please continue to the Skill Check on the next page. PN: A62452A (June 2013) S-25 of 48 Beckman Coulter Professional Development

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27 CALIBRATION SKILL CHECK 1. When should you calibrate? 2. What parameters are calibrated on the DxH 600 System? a. CBC and Diff b. CBC c. CBC, Diff and Retic d. Diff and NRBC 3. Which of the following are valid reasons to run S-CAL calibrator to verify calibration settings? a. Controls show unusual trending. b. On the Calibration Run Table a parameter checkbox is selected. c. Ambient room temperature changes by more than ± 10º F from the calibrating temperature. d. According to your laboratory or regulatory agency specifications. PN: A62452A (June 2013) S-27 of 48 Beckman Coulter Professional Development

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29 OBJECTIVES FLAGGING LIMITS Given an operating DxH 600 System and using the System HELP: Set up flagging limits for whole blood Process samples to show that the flagging limits entered are applied Why Is It Important? Setting up appropriate flagging limits for your laboratory ensures that normal and abnormal specimen results are properly identified for further review. Changing flagging sensitivity can accommodate flagging seen in specific patient populations. Resources DxH 600 System System HELP Several tubes of EDTA blood specimens Bar code labels PN: A62452A (June 2013) S-29 of 48 Beckman Coulter Professional Development

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31 INFORMATION/PRACTICE Adding Flagging Limits Step Action Select: Menu> Setup> Flagging/Rules> Flags>Flagging Limits Tab 1 2 Note Note 3 From the Flagging Limits Tab, select the Add Limit button on the local navigation bar and create a limit. The Limit Ranges you will modify in the next steps for Action and Definitive Limits are designed to force flagging on the normal samples that we have in the classroom. They are not meant to be real life examples! As you change each value, you may see a message about incorrect value. Just select OK and continue. Specimen Type Whole Blood. Use the drop-down list. Limit Name Class Adult Location Class Test. Use the drop-down list or select the + to add a Location. Age Range From 0 Hours, To 150 years. Note: You enter the age range, you can select the View Age Range button to display a graphical view of the selected range. You can also select View Age Range to view the graphical display when you get an age range overlap violation. PN: A62452A (June 2013) S-31 of 48 Beckman Coulter Professional Development

32 Use the Copy Limit to copy from the original Adult set. From the Flagging Set Copy Source, select Adult Default. Select the Copy All Available check box. Select Copy. For classroom practice, make the following changes. Reference Limits for Male/Female. Reference tab: Male Female WBC RDW PLT Type in one or two Action/Critical Limits. Action /Critical Limits tab: Action Critical WBC RDW PLT Type in one or two Definitive Male/Female Limits. Definitive Male and Female tabs: Male & Female Limits WBC RDW (Aniso 1+) (Aniso 2+) (Aniso 3+) PLT Note: MCV, MCH and RDW have gradient ranges available. S-32 of 48 Beckman Coulter Professional Development PN: A62452A (March 2013)

33 4 To enable this limit as the system default for this specimen type, select the check box. 5 Select OK to Save. Note In the Flagging Limit Setup screen, you may select the H&H Check button to enable or disable this check. You may also change the calculation from the default. 6 Obtain 3 downtime bar code labels and three blood specimens. 7 Process your specimens. Look for the three Definitive Messages you set up. If all three messages are not present, verify your input, make any necessary corrections and rerun your specimens. Flagging Sensitivity Step Action Select: Menu> Setup> Flagging/Rules> Flags> Flagging Sensitivity Tab 1 Note The three areas you may adjust are Variant Lymphs, Left Shift and Immature Granulocytes. The default setting for all of these is set to High. Before making a decision to change these settings, you should perform a Truth Table Analysis to determine the best setting for your particular patient populations. PN: A62452A (June 2013) S-33 of 48 Beckman Coulter Professional Development

34 You reached the goal! Please continue to the Skill Check on the next page. S-34 of 48 Beckman Coulter Professional Development PN: A62452A (March 2013)

35 FLAGGING LIMITS SKILL CHECK 1. Show facilitator the limit set you created. 2. Show facilitator the flagging from the definitive message settings used. 3. Show facilitator the reports of the samples you ran. PN: A62452A (June 2013) S-35 of 48 Beckman Coulter Professional Development

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37 OBJECTIVES DECISION RULES Given an operating DxH 600 System and using System HELP: Create and apply a Decision Rule so that an action posts either to the Lab Action area or to the Comments area. Enable and edit the ISLH (International Society for Laboratory Hematology) Consensus rules. Enable and edit the Instrument Rules. Why Is It Important? Decision Rules assist laboratorians with data review by clearly showing what actions(s) should be taken based on sample parameter results, flags, codes and messages. Resources DxH 600 System System HELP Several EDTA specimens Bar code labels PN: A62452A (June 2013) S-37 of 48 Beckman Coulter Professional Development

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39 INFORMATION/PRACTICE The Rules button takes you to screens where you can select Release Rules, add or edit Decision Rules at a workbench, or view Active Decision Rules. Ensure that each of the following is a clear and distinct section: Release Rules, Decision Rules Workbench, and Active Decision Rules. The Decision Rules let you define conditions that will initiate system or laboratory follow-up actions. You must validate any new decision rules that you add to avoid erroneous results. Restoring Predefined Rules Two types of predefined rules are available in the system: Consensus rules Instrument rules The Consensus rules were created by the ISLH using an international committee of Hematology experts. If you select Restore Predefined Rules, after acknowledging a dialog box, it will post 41 rules, named CR1 to CR41. These Consensus rules are disabled by default. Instrument rules, named IR1 to IR16, are defined by Beckman Coulter and are offered as suggestions to possible enhancement of in-lab workflow. To use a rule without changing its contents, you must activate and enable that rule. To modify a Predefined rule for your own laboratory policies, you must Copy the rule first in order to edit it, then activate and enable. PN: A62452A (June 2013) S-39 of 48 Beckman Coulter Professional Development

40 Release Rules Tab Step Action Select: Menu>Setup>Flagging/Rules>Rules 1 2 Select one of the following. 3 The Release Rules tab lets you select from the following options:: Hold all Results All processed results will be held at the Worklist Review tab. Hold all Exceptions All processed results with exceptions will be held at the Worklist Review tab. Release all Results All processed results will be reported (printed or transmitted as the system is configured) including any triggered Decision Rules actions. Release results based on decision rules All results that trigger a Decision Rule action will be held at the Worklist Review tab. Choose the fourth option for this class exercise. 4 Select Save to save your settings. S-40 of 48 Beckman Coulter Professional Development PN: A62452A (March 2013)

41 Create a Decision Rule (Decision Rules Work Bench) Step Action Select: Menu>Setup>Flagging/Rules>Rules 1 Select the Decision Rules Workbench tab. 2 Select button to display the Decision Rule Setup dialog box. Enter the following information to create a rule: o Rule Name: WBC o Rule Description: WBC Rule o Specimen Type: Whole Blood 3 PN: A62452A (June 2013) S-41 of 48 Beckman Coulter Professional Development

42 4 5 Select button to create the following rule: If WBC is >2.0 or <15.0, then perform a manual diff. Add a suggested action and comment. Select: Test Result o Test Result: WBC o > 2.0 o Select: OK 6 Select: 7 Select: Test Result o Test Result: WBC o < 15.0 o Select: OK THEN Actions Lab Actions (ie: Perform a Manual Diff). 8 9 Select OK. Note This rule will force the application on a normal specimen for the purposes of the classroom exercise. Do not use the option to attach a Specimen ID. S-42 of 48 Beckman Coulter Professional Development PN: A62452A (March 2013)

43 (Activate Decision Rules) Step Action Note You must be OFFLINE in order to Activate Decision Rules! Select: Menu>Setup>Flagging/Rules>Rules 1 2 Select the tab. Select and select the rule/rules to be activated. 3 All the rules created in the Decision Rules Work Bench and are not active will appear here. PN: A62452A (June 2013) S-43 of 48 Beckman Coulter Professional Development

44 Note You may also choose the position (priority) of this rule in the list of active rules. The two options are: Insert at selected row Insert after selected row 4 Select the rule you created and select OK. The Active Decision Rules Tab lists your Active Decision Rules. 5 Created Rule Enable Rule Select the Decision Rule as highlighted above in blue. Select: Enable Rule icon to enable your Decision Rule. Note: If you created more than one Decision Rule, you may selecte them all at once and activate them. You may do the same to Disable Rules. The Decision Rule is Enabled. 6 Enable S-44 of 48 Beckman Coulter Professional Development PN: A62452A (March 2013)

45 Practice/Create Your Own Rule Now create one or two rules of your own. They could be something you use in your own lab, or something you make up for use in the classroom. Be creative! Remember that to run them here, we usually have only normal specimens. Edit and Copy Decision Rules Step Action Copying Decision Rules From the Workbench Tab 1. Select a rule or a series of rules to copy. 2. Select Copy Rule to display the Decision Rule Setup dialog box 3. When the system displays: a. Are you sure you want to copy the selected rules? select YES to automatically copy the rule to the end of the existing list on the Workbench tab. b. The rule copy is named Copy of XXX. You can edit the name and rule. Note From the Active Decision Rule Tab 1. Select a rule or a series of rules to copy. 2. Select Copy Rule to Workbench to display the Decision Rule Setup dialog box. 3. When the system displays: a. Are you sure you want to copy the selected rules? select YES to automatically copy the rule to the end of the existing list on the Workbench tab. 4. When the system displays: a. Copied 1 rule to the decision rule workbench. Select OK to put the rule on the Decision Rule Workbench b. The copy has the same name as the rule on the Active Decision Rule tab. It does not say Copy of XXX. You can edit the name and Rule. PN: A62452A (June 2013) S-45 of 48 Beckman Coulter Professional Development

46 Enable Consensus Rules & Instrument Rules Select the button for Restore Predefined Rules. There are 41 consensus rules and 16 instrument rules. After opening the rules, if you wish to edit first, copy and rename the rule. For additional reference, refer to the Set-up Chapter 9 in HELP. Try this now! You reached the goal! Please continue to the Skill Check on the next page. S-46 of 48 Beckman Coulter Professional Development PN: A62452A (March 2013)

47 DECISION RULES SKILL CHECK 1. Show your sample results/printouts to the facilitator with a rule that was applied to the results. 2. Show facilitator a consensus rule that you enabled/edited. 3. Show facilitator an instrument rule that you enabled/edited. PN: A62452A (June 2013) S-47 of 48 Beckman Coulter Professional Development

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