3M #3968, #3960 manual Running Quality Control, Accept

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3M™ Rapid Detection Reader

Running Quality Control

Running Quality Control

Two types of quality control test records are stored by the 3M Rapid Detection Reader:

LQC (Liquid Quality Control) - external surrogate sample test results.

IQC (Internal Quality Control) - self-diagnostic test results including a check of the power supply voltage, system memory, cartridge transport system, cartridge barcode sensor, LED function, and incubator function for heated assays.

Running LQC

1.From the Main Menu screen (Figure 4) touch LQC. The LQC – Assay List screen will open (Figure 9). This screen will display the entire list of assays sorted in ascending order by the Time to Expiry before assay lockout as displayed in the LQC Expiration column. If LQC is due, this column will display “Run x of y levels” where x is the number of levels required and y is the number of defined LQC levels for that assay. Both the number of levels required and the available defined levels are set using the RCU.

The LQC status column shows the requirements for any LQC levels that have failed. If any LQC fails, that specific control level must be run successfully prior to proceeding with a patient’s test. If the maximum number of Failures before LQC Lockout is reached, this column will display “LQC Lockout”.

NOTE: The assay list is defined in RCU. Any new assays added in the RCU or through the CM will default to LQC disabled and will be listed with N/A in the LQC Expiration column. Refer to the RCU Help Manual for further instruction.

2.Select the assay for which LQC will be performed. Touch Run LQC. If prompted, enter Operator ID and/or Password using either the touch screen or the barcode scanner. To accept the displayed information touch Accept.

NOTE: Both the Operator ID and Password are case-sensitive.

Figure 9. LQC - Assay List

Figure 10. Control ID Entry

3.When prompted (Figure 10), select the appropriate Control ID using the drop down menu. Touch

Accept.

NOTE: If LQC has failed for the assay selected, the number of LQC attempts allowed prior to assay lockout is displayed.

4.When prompted to Add Control & Insert the Test Cartridge, the LED on a free port of the TM will

flash blue and the corresponding port icon on the display will illuminate blue (Refer to Test Kit and Quality Control Package Inserts for detailed instructions).

5.Prepare Test Cartridge as per Test Kit Package Insert and insert Test Cartridge into the flashing port.

If the cartridge is not inserted within 5 minutes of the Add Control & Insert prompt, the system will time-out and return to the Main Menu.

NOTE: The Test Cartridge must be inserted into the TM within ~30 seconds of sample application. Otherwise, FAIL will be displayed in the port icon and the assay will be aborted.

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Contents Operator Manual Made in Canada for Table of Contents Maintenance Iii Consult Accompanying Documents Consult Operator Manual Read all contents of this manual prior to useTo reduce the risk of instrument or accessory damage Summary of Warnings and PrecautionsTo reduce the risk associated with hazardous voltage To reduce the risk associated with incorrect resultsIntended Use IntroductionOverview 3M Rapid Detection Reader Components Unpacking and SetupOptional Accessories Available from 3M To set-up 3M Rapid Detection Reader 3M Rapid Detection Reader SetupBarcode Scanner § 3M Rapid Detection Control Module CM3M Rapid Detection Reader 3M Rapid Detection Test Module CM Port 3M Rapid Detection Control ModuleTurning on the 3M Rapid Detection Reader Reader Configuration Utility RCU supplied with the CM. For3M Rapid Detection Reader Modules Port Identification Nomenclature Display IconsStarting an Assay Using Lot CardsPerforming an Assay Operator Entry Accept Running Quality ControlAssay Status Warnings LQC IconsTo run IQC automatically Running IQCTo run IQC manually Viewing Saved Logs Working with Results and LogsViewing Saved Results Searching Logs Searching ResultsResults Transfer Manually Transferring / Printing Results or LogsLQC Managing SettingsAssay Settings View TabsTimer Printer LoginNetwork Settings Login RequirementsFile Privilege RequirementsAbout Settings View About TabTimers Edit SettingsSettings Edit Tabs Date/Time Manual / Auto Transfer ModeLanguage MiscSound Restoring DefaultsManaging Operators To Add an Operator Adding/Modifying an OperatorTo Modify an Operator Touch Search or CancelSearching for an Individual Operator Installation Editing Settings Using the Reader Configuration Utility RCULogin Getting StartedChoosing a Configuration File Access Method Emergency Password Reset MechanismSetting Up a USB Flash Drive Setting Up Web Services AccessTo open all files for a group Accessing Configuration FilesFiles Setting Up Communications Between RCU and ReadersTo open an Individual Configuration File Non-networked Environment Identifying Readers through the RCUNetworked Environment Touch Export to USB Flash DriveExporting Files Importing FilesDelete Results Prior to Date Deleting ResultsPossible device damage MaintenanceExterior Cleaning Disposal of Equipment Upgrading Device SoftwareGeneral TroubleshootingRestoring the Supervisor Operator ID / Password Test Run Messages Power On Self Test Message / IQC MessagesNo Available Ports. IQC Failed To Start FailInsertion Error Remove & Reinsert Followed by Timed Out ErrorLot Card Messages Settings Messages LQC Related Messages Printer Errors USB Device Errors Communications ErrorsUnrecognized USB Drive Attached, Remove Device Specifications Storage temperature Operating temperatureOperating Humidity Operating/Storage3M Rapid Detection Reader IndexRestoring Supervisor Operator ID Password Languages Upgrading Software See RCU USB