Nothing Special   »   [go: up one dir, main page]
Scribd Logo
Upload

Welcome to Scribd!

  • 24 views

    FE1E04200C74E0479F

    Uploaded by

    stel stel
    This document provides instructions for using the Quidel Triage MeterPro. It includes information on setting up the meter by unpacking it, installing paper and a supervisor code chip. The document describes how to change meter settings like the clock, user ID, test settings and quality control parameters. It also explains how to run tests on patient samples, recall past results, and install reagent code chips. The manual contains detailed steps for operating and getting the most out of the Quidel Triage MeterPro.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    FE1E04200C74E0479F

    Uploaded by

    stel stel
    24 views86 pages
    This document provides instructions for using the Quidel Triage MeterPro. It includes information on setting up the meter by unpacking it, installing paper and a supervisor code chip. The document describes how to change meter settings like the clock, user ID, test settings and quality control parameters. It also explains how to run tests on patient samples, recall past results, and install reagent code chips. The manual contains detailed steps for operating and getting the most out of the Quidel Triage MeterPro.

    Original Description:

    Fe1e04

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    This document provides instructions for using the Quidel Triage MeterPro. It includes information on setting up the meter by unpacking it, installing paper and a supervisor code chip. The document describes how to change meter settings like the clock, user ID, test settings and quality control parameters. It also explains how to run tests on patient samples, recall past results, and install reagent code chips. The manual contains detailed steps for operating and getting the most out of the Quidel Triage MeterPro.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    24 views86 pages

    FE1E04200C74E0479F

    Uploaded by

    stel stel
    This document provides instructions for using the Quidel Triage MeterPro. It includes information on setting up the meter by unpacking it, installing paper and a supervisor code chip. The document describes how to change meter settings like the clock, user ID, test settings and quality control parameters. It also explains how to run tests on patient samples, recall past results, and install reagent code chips. The manual contains detailed steps for operating and getting the most out of the Quidel Triage MeterPro.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 86

    

    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    

    UserManual
    Page1of86
    
    
     
     Asymbolsglossarycanbefoundatquidel.com/glossary. 
    
    
    TableofContents
    TableofContents............................................................................................................................... .............2
    GeneralInformation............................................................................................................................... .............5
    QuidelContactInformation............................................................................................................................. 5
    MainMenuStructure............................................................................................................................... .......6
    LabelsandSymbols............................................................................................................................... ..........7
    Warnings,PrecautionsandLimitations...........................................................................................................9
    Introduction............................................................................................................................... ........................10
    HowtoUseThisGuide............................................................................................................................... ...10
    Description............................................................................................................................... .....................10
    WhatistheQuidelTriageMeterPro?.......................................................................................................10
    Unpacking............................................................................................................................... ...................11
    Installation............................................................................................................................... ..........................15
    UnpackMeter............................................................................................................................... .................15
    PowerMeterOn............................................................................................................................... .........15
    InstallPaper............................................................................................................................... ................16
    InsertSupervisorCodeChipModule.........................................................................................................17
    ToChangeMeterSettings......................................................................................................................... 17
    ChangeClock............................................................................................................................... ..............19
    SetUserID............................................................................................................................... ..................20
    ChangeReferenceRanges/ThresholdsforTests:......................................................................................20
    ChangeTestSettings............................................................................................................................... ..20
    ChangeQCParameters.............................................................................................................................. 21
    ChangeBypassSettings............................................................................................................................. 21
    SetParameters............................................................................................................................... ...............23
    Purpose............................................................................................................................... .......................23
    ListofProgrammableParameters.............................................................................................................23
    SupervisorAccess............................................................................................................................... .......23
    HowtoSetParameters:BasicInstructions...................................................................................................24
    MeterSettings............................................................................................................................... ............25
    IDSettings............................................................................................................................... ...................25

    Page2of86
    InstallCodeChip............................................................................................................................... .............37
    Purpose............................................................................................................................... .......................37
    TypesofCODECHIPmodules....................................................................................................................37
    InstallationofReagent,QCSampleorQCDeviceCODECHIPModules...................................................37
    Operation............................................................................................................................... ...........................39
    AccesstotheQuidelTriageMeterPro..........................................................................................................39
    RunTest............................................................................................................................... ..........................39
    Purpose............................................................................................................................... .......................39
    Options............................................................................................................................... .......................39
    RecallResults............................................................................................................................... ..................49
    Purpose............................................................................................................................... .......................49
    Function............................................................................................................................... ......................49
    LastRecord............................................................................................................................... .................49
    PatientResults............................................................................................................................... ............50
    PatientID............................................................................................................................... ....................50
    TestDeviceLotNumber(L/N)...................................................................................................................51
    UserID............................................................................................................................... ........................52
    FromDate............................................................................................................................... ...................52
    TillDate............................................................................................................................... .......................53
    QCResults............................................................................................................................... ...................54
    QCSampleLotNumber(L/N)....................................................................................................................55
    DeviceLotNumber(L/N)........................................................................................................................... 55
    UserID............................................................................................................................... ........................56
    FromDate............................................................................................................................... ...................57
    TillDate............................................................................................................................... .......................57
    ReagentLots–QC............................................................................................................................... ......58
    ArchiveLastTest............................................................................................................................... .........58
    Misc.TestResults............................................................................................................................... .......59
    Misc.TestID............................................................................................................................... ...............59
    TestDeviceLotNumber(L/N)...................................................................................................................60
    UserID............................................................................................................................... ........................61
    FromDate............................................................................................................................... ...................61
    TillDate............................................................................................................................... .......................62
    PrintAllResults............................................................................................................................... ...........63
    PatientResults............................................................................................................................... ............63
    QCSampleResults............................................................................................................................... ......63

    Page3of86
    QCDeviceResults............................................................................................................................... .......64
    Misc.TestResults............................................................................................................................... .......64
    UploadResultstoLIS............................................................................................................................... ..64
    DeleteResults............................................................................................................................... .................64
    Purpose............................................................................................................................... .......................64
    TheQuidelTriageMeterProMemory.......................................................................................................65
    DeletePatientResult............................................................................................................................... ..65
    DisplayBacklight............................................................................................................................... .............66
    AlphaNumericMode............................................................................................................................... .....67
    ServiceandMaintenanceProcedures...............................................................................................................68
    PaperReplacement............................................................................................................................... ........68
    ChangingPaperBetweenFunctions..........................................................................................................68
    ChangingPaperWhilePrinting..................................................................................................................69
    Cleaning............................................................................................................................... ..........................70
    CheckBatteryLevel............................................................................................................................... ........70
    BatteryReplacement............................................................................................................................... ..70
    TotalQualityAssurance............................................................................................................................... ..71
    Introduction............................................................................................................................... ................71
    QualityAssuranceFunctions.....................................................................................................................72
    InternalDeviceQualityAssurance............................................................................................................72
    MeterQualityAssurance........................................................................................................................... 73
    SoftwareQualityAssurance...................................................................................................................... 73
    QualityControlSamples............................................................................................................................ 74
    NotesRegardingSoftwareControls..........................................................................................................74
    Appendices............................................................................................................................... .........................76
    AppendixASpecifications............................................................................................................................. 76
    MeterSymptoms............................................................................................................................... ........77
    AppendixBTroubleshooting......................................................................................................................... 78
    MeterMessageorSymptom.....................................................................................................................78
    AppendixCReturnandDisposalProcedures................................................................................................80
    ReturnProcedure............................................................................................................................... .......80
    DisposalProcedure............................................................................................................................... .....80
    AppendixDGlossary............................................................................................................................... .......80
    AppendixESampleLogSheets...................................................................................................................... 82
    

    Page4of86
    GeneralInformation
    
    QuidelContactInformation
    ContactQuidelTechnicalSupportfrom7:00a.m.to5:00p.m.PacificTime
    Tel:  800.874.1517(intheU.S.);
    858.552.1100(outsidetheU.S.)
    Fax:  858.552.7905
    Email:  technicalsupport@quidel.comorcontactyourlocaldistributor
    Website: quidel.com
    
    IfoutsidetheU.S.contactlocaldistributororoneoftheTechnicalSupportcenterslistedbelow.Youmay
    alsocontactusatquidel.com.

    Region Phone EͲmailAddress


    EuropeandMiddleEast +44.161.483.9032 EMEproductsupport@alere.com
    AsiaPacific +61.7.3363.7711 APproductsupport@alere.com
    Africa,RussiaandCIS +972.8.9429.683 ARCISproductsupport@alere.com
    LatinAmerica +57.2.6618797 LAproductsupport@alere.com
    Canada +1.613.271.1144 CANproductsupport@alere.com
    
     

    Page5of86
    
    MainMenuStructure

    InstallNew Set Delete


    RunTest RecallResults
    CODECHIP Parameters* Results*

    *SupervisorCODECHIPOnly

    Patient QC QC Misc. Meter Test QC


    Clock UserID Ranges Bypass
    Sample Device Sample Test Settings Settings Parameters

    x NewUserID x QCDeviceFreq.
    Misc. Upload
    Last QC Patient PrintAll x UpdateUserID x QCSampleFreq.
    Test Results
    Record Results Samples Results x DeleteUserID x NumberofControls
    Results toLIS
    x UserIDList x NumQuantStdDevs

    x QCSampleResults
    x QCDeviceResults ID Display Comm
    x ReagentLots–QC Settings Settings Settings
    x ArchiveLastTest

    x CharactersUserID x Language
    x x BaudRate
    CharactersPat.ID x PrintMode
    x x Pat.ResultApproval
    CharactersAux.ID x AutoPowerͲOff
    x x LISEnable/Disable
    Aux.IDEnable/Disable x DisplayContrast
    x x AutoUpload
    CharactersMisc.ID x PrinterContrast

    
     

    Page6of86
    LabelsandSymbols
    Label/Symbol Description

    Manufacturer
    

    Invitrodiagnosticmedicaldevice
    

    Consultinstructionsforuse
    

    AuthorizedrepresentativeintheEuropeanCommunity
    

    Temperaturelimitation

    Humiditylimitation

    Wasteelectricalandelectronicequipment(WEEE)

    SerialNumber
    

    CatalogNumber
    

    Warning/Caution
    
    
    

    Important
    
    

    
     

    Page7of86
     
    
    CEmark Batchcode Dateofmanufacture

      
    UseͲbydate Intendeduse Upperlimitoftemperature

      
    DonotreͲuse ChinaRoHS Patientnumber

      
    Testdevice Control CalibrationVerification

      
    Prescriptionuseonly Contents/contains Expectedvalues

       
    Biologicalrisks Thaw Transferpipette

      
    Mean Standarddeviation CODECHIPmodule

       
    PrinterPaper Peelopenhere Addsamplehere

    
       UseEDTAwholebloodorplasma
    UseEDTAplasmasampleonly Useurinesampleonly sampleonly

    
    Addsampleimmediatelyafter 
    openingfoilpouch  
     

    Page8of86
    Warnings,PrecautionsandLimitations
    „ TheQuidelTriageMeterPromustbeusedwithintheoperatingtemperaturerangerequiredbythe
    specifictestdeviceproductbeingused.Refertothetestdevicepackageinsertfordetails.
    
    „ OperatetheQuidelTriageMeterProonalevel,drysurfaceawayfromdirectsunlight.
    
    „ TheQCDeviceislightͲsensitiveandshouldbestoredinitsblackopaquecasewhennotinuse.
    
    „ DoNOTwriteorplacealabelanywhereontheQCdevice,asitmayinterferewiththedevice
    functionality.
    
    „ DonotmovetheQuidelTriageMeterProwhileatestisinprogress.
    
    „ Ensureallsamplefluidshaveabsorbedintothetestdevicepriortorunningthetesttopreventinternal
    contaminationofthemeter.
    
    „ UseonlytheAC/DCpoweradapterprovidedwiththeQuidelTriageMeterPro.Anidentifyingtaghas
    beenplacedonthecordforquickidentification.
    
    „ DonotdropQuidelTriageMeterPro.
    
    „ DonotplaceobjectsontheQuidelTriageMeterPro.
    
    „ DonotimmersetheQuidelTriageMeterProinwateroranyliquids.

     

    Page9of86
    Introduction
    
    HowtoUseThisGuide
    Thismanualcontains:
    „ InstructionsfortheoperationandmaintenanceoftheQuidelTriageMeterPro,and;
    „ Basicinstructionsfortestingsamples

    NOTE:Torunspecifictests,suchastheQuidelTriageCardiacPanel,youalsowillneeddetailed
    informationcontainedintheproductͲspecificPackageInsert,includedinthetestkit.

    
    TheQuidelTriageMeterProsoftwarehasbeendesignedtoprovidetheuserstepbystepinstructions.The
    meterdisplaystestresultsandmenuoptionsintheupperhalfofthemeterscreen.Insmallerlettersatthe
    bottomofeachscreen,themeterdisplaysinstructionspertainingtothetaskbeingperformed.
    
    8:23AM01•20•18
    
    RUNTEST
    RECALLRESULTS
    INSTALLNEWCODECHIP
    
    SELECTWITHvOR^ANDPRESSENTER
    PRESSEXITTOEJECTDEVICE
    
    TheQuidelTriageMeterProUserManualisdividedintosixsections.
    Section1– GeneralInformation:Contactinformation,MenuStructurefortheQuidelTriageMeterPro,
    Symbols,WarningsandPrecautions
    Section2–Introduction:ProvidesanoverviewoftheQuidelTriageMeterPro.
    Section3– Installation:Guidestheuserthroughfirsttimesetup.
    Section4– Operation:Guidestheuserthroughrunningtests,recallingresultsanddeletingresults.
    Section5– ServiceandMaintenanceProcedures:PaperReplacement,Cleaning,Batteries,TotalQuality
    Assurance,andWarranty.
    Section6– Appendix:Specifications,Troubleshooting,ReturnandDisposal,Glossary,SampleLogSheets
    
    
    Description
    WhatistheQuidelTriageMeterPro?
    TheQuidelTriageMeterProisaportablefluorescenceinstrumentusedtomeasuretheresultsoftests
    manufacturedbyQuidelCardiovascularInc.TheQuidelTriageMeterProcanbeusedinalaboratoryorina
    pointͲofͲcaresetting.
    
    TheQuidelTriageMeterProusesalaserasalightsource.Lightfromthelaserhitsatestdevicethathas
    beeninsertedinthemeter.Thiscausesthefluorescentdyeinthetestdevicetogiveoffenergy.Themore
    energythefluorescentdyegivesoff,thestrongerthesignal.

    Page10of86
    

    TriageTestDevice.Atestdeviceholdsthe
    sampleandalsocontainsthereagentsand
    othermaterialsneededforthetest.
    
    
    Overview:RunningaTest
    Afteratestsample(forexample,blood)fromapatientisaddedtothetestdevice,thetestdeviceisinserted
    intheQuidelTriageMeterPro.Themetermeasureshowmuchofthesubstance(aparticularprotein
    marker)ispresent,basedonstandardsthathavebeenpreͲprogrammedintothemeter.Thepatient
    identification,theUserI.D.andthetestresultscanbeprintedoutonapapertape.

    
    
    Inadditiontotestingsamplesfrompatients,theQuidelTriageMeterProcontainspreͲprogrammedQuality
    Control(QC)functionsthatallowthepersonoperatingthemetertomonitorqualitycontrol.
    

    NOTE:TheQuidelTriageMeterProacceptstestdevicesthataredesignedspecificallyforusewiththe
    QuidelTriageMeterPro.PleaserefertoproductͲspecificPackageInsertsincludedineachtestkitformore
    information.

    
    Unpacking
    TheQuidelTriageMeterProandtheitemsthatcomewithitareprovidedinasinglebox.
    QuidelTriagetestdevicesarepackagedseparatelyandincludeinstructionsforrunningspecifictests.Ifyou
    haveanyquestions,contactQuidel(refertotheAssistancesection).
     

    Page11of86
    Contents
    „ QuidelTriageMeterPro
    „ QCDeviceandCODECHIPmodule(intheQCDevicebox)
    „ AC/DCPowerConverter
    „ AABatteries
    „ RollsofPrinterPaper(additionalrollsaresuppliedineachboxoftestdevices)
    „ SupervisorCODECHIPmoduleandCODECHIPmoduleBox
    
     

    Printerpaper
    locatedbelow
    QCDevicebox.

    Page12of86
    PartsoftheQuidelTriageMeterPro

    Page13of86
    
    On/OffKey UsedtoturntheQuidelTriageMeterProonandoff.
    (Powerbutton) 

    PrintKey  Usedtoprintthetestresultsordisplayscreen.

    DeleteKey  Usedtodeletedata.

    Allowstheoperatortoselectmenuitemsandacknowledgealarm
    EnterKey 
    conditions.

    ExitKey  Usedtoexitthedisplayedmenuorejectthetestdevice.

    BrightnessKey  Usedtosetscreenbrightness
    
    Keypad Usedtoenteridentificationnumbers,letters,andspecialsymbols.
     Usedtotogglethroughmenuitems.

     Up

    Down
    ArrowKeys 
    Left
    
    Right
    
    
    ShiftKey 

    SymbolKey  UsedwithShiftKey
    
    ThermalPrinter Printsthetestresultonpaper.
    Connectionpointforthe(optional)BarCodeScanner,allowingthe
     operatortoscanpatientoruseridentificationdatainsteadofmanually
    DataPort
    enteringnumbersorlettersonthekeypad.Mayalsobeusedtoconnect
    toadatamanagementsystem/LIS.
    PaperFeedKey  Usedtofeedpaper

    CODECHIP  InsertionpointforCODECHIPmoduleswhichcontainlot/devicespecific
    ModulePort dataforuseinprovidingtestresults.
    PowerSupplyPort  ConnectionpointforthesuppliedAC/DCPowerConverter.

    PrinterCover  Thecover,whichwhenpulledstraightup,revealsthepaperroll.
    TheLCD(LiquidCrystalDisplay)Screenshowsthemenuofpossibletests
    LCDScreen 
    andtasksandpromptstheoperatortotakethenextstep.
    ScreencommandsandoptionsareindicatedbyaBOLDEDFONT. 

    Page14of86
    Installation
    UnpackMeter
    a. Removethemeterfromtheboxandprotectiveplasticbag.
    

    PowerMeterOn
    Batteries
    a. Turnthemeterover.
    b. Removebatterycover.
    c. Install4AAbatteries,payingattentiontobatteryorientationinthe
    batterycompartment.
    d. Replacebatterycoverandturnmeterrightsideup.

    e. Powerthemeteronbypressingthe key.Pressthe key


    torunselfͲtest.Whenthetestiscompleted,thescreenmeter
    displaywillcometorestatthemainmenu.
    
    
    

      8:23AM01•20•18
    LowPowerIndicator  
    Timeanddate
    
    
    RUN Menuitems
    TEST
    RECALLRESULTS
    INSTALLNEWCODECHIP
    
    SELECTWITHvOR^ANDPRESSENTER
    UserInstructions
    PRESSEXITTOEJECTDEVICE
    TheMainMenu
    

    NOTE:TheLowPowerIndicatormonitorstheactivepowersource.Toverifyadequatebatterpower:
    „ NavigatetotheMainMenu
    „ RemovetheACpowersupply
    „ PresstheEXITkey(themeterattemptstoejectthedevice)
    „ ObservetheMainMenuonthemeter’sdisplay.
    „ Replacethebatteriesifthepowericonisvisible.

    
     

    Page15of86
    ACPowerSupply
    a. Removethepowersupplyfromthebox.
    b. PlugoneendintoanACoutlet.
    c. Plugtheoppositeendintotheroundholeinthebackofthemeter.
    
    InstallPaper
    a. Removetheprintercoverbypullinguponthecoverasindicatedbythearrowonthebackofthecover.
    
    

    
    
    FormoredetailsaboutInstallingPaperseetheCareandMaintenancesection.
    
    b. Tearorcutaclean,straightedgetofeedintotheprinter.Donotcutpaperatanangle,astheprinter
    mustsensetheedgeofthepaperalongthefeedpath.
    

    
    

    NOTE:Theprintercontainsapapersensorandwillfeedthenewpaperrollonlywhenpaperwithaclean
    straightlineispressedintothepaperroller.

    c. Positionthepapersuchthatthepaperwillfeedfromundertheroll(asopposedtooverthetopofthe
    roll,seepicture).
    
    
     
     
    
    
    
    

    Page16of86
    d. Insertthepaperedgeunderthepaperroller(platen)untilitfirmlyseatsorresistanceisfelt.
    e. Pressthe keytwice,paperwillfeedthroughtheprinterandextendoutthemeter.
    f. Placetherollofpaperintothepapercompartment.
    g. Replacetheprintercoverandcontinueoperation.
    
    InsertSupervisorCodeChipModule
    a. RemovetheSupervisorCODECHIPmoduleBoxfromthemeterbox.
    b. RemovetheSupervisorCODECHIPmodulefromitsbox.
    c. InserttheSupervisorCODECHIPmoduleintotheCODECHIPmodulePort.Theportislocatedontheleft
    sideofthemeter,towardsthebottomfrontcorner.NotetheorientationoftheCODECHIPmodulein
    thedrawingbelow.
    d. OncetheSupervisorCODECHIPmoduleisinstalled,verifythattwoadditionalmenuitemsappearonthe
    displayscreen.
    8:23AM01•20•18 
    

    RUNTEST
    RECALLRESULTS
    INSTALLNEWCODECHIP
    Twoadditionalmenuoptions SETPARAMETERS
    accessiblewhenSupervisor
    CODECHIPmoduleisinserted. DELETERESULTS
    

    SELECTWITHvOR^ANDPRESSENTER
    PRESSEXITTOEJECTDEVICE
    TheSupervisor’sMainMenu
    

    
    
    
    FormoredetailsaboutCODECHIPmoduleseepage22.
    
    ToChangeMeterSettings
    a. SelectSETPARAMETERSusingthe  keysandpressthe key.

    b. SelectMETERSETTINGSusingthe  keysandpressthe key.

    Page17of86
    c. SelectIDSETTINGS,DISPLAYSETTINGSorCOMMSETTINGSusing

    the  keysandpressthe key.

    d. Selectthedesiredsettingusingthe  keysandchangethevalueofthesetting

    byusingthe  keys.
    
    
    IDSettings Default Options  NewSettings
    CHARACTERSUSERID Min1 1Ͳ16 
    Max16 1Ͳ16
    CHARACTERSPAT.ID Min1 1Ͳ20 
    Max20 1Ͳ20
    CHARACTERSAUXID Min1 1Ͳ12 

    
    Max12 1Ͳ12
    CHARACTERSMISCID Min1 1Ͳ20 
    
    Max20 1Ͳ20
    AUX.IDENABLE/DISABLE Disabled Disabled,Enabled 

    Forreference,recordyoursettingsinthespaceprovided.
    
    e. Pressthe keytosavechangestoIDSettings.

    DisplaySettings Default Options NewSettings


    LANGUAGE English English,French,Italian, 
    German,Spanish,
    Portuguese,Greek,
    Danish,Swedish,
    Japanese
    PRINTMODE Automatic Automatic,Manual 

    AUTOPOWERͲOFF 2hour 1/2hour,1hour,2 


    hour,4hour,None
    DISPLAYCONTRAST 4 0Ͳ8 
    (8=Heaviestcontrast)
    PRINTERCONTRAST 4 0–8 
    (8=heaviestcontrast)
    Forreference,recordyoursettingsinthespaceprovided.
     

    Page18of86
    f. Press tosavechangestoDisplaySettings.

    COMMSettings Default Options NewSettings


    BAUDRATE   

    PAT.RESULTAPPROVAL 'LVDEOHG (QDEOHG'LVDEOHG 

    LISENABLE/DISABLE 'LVDEOHG 'LVDEOHG(QDEOHG 

    AUTOUPLOAD 'LVDEOHG 'LVDEOHG(QDEOHG 

    LISPASSWORD   

    g. Pressthe keytosavechangestoCommunicationSettings.

    h. Pressthe keytosavechangestoMeterSettings.


    
    FormoredetailsaboutCommunications,includingentryofaQuidelprovided,meterspecificpassword,see
    page29.
    
    ChangeClock
    a. SelectSETPARAMETERSusingthe  keysandpressthe key.

    b. SelectCLOCKusingthe  keysandpressthe key.

    c. SelecttheHOUR:MINUTEareausingthe  keys.Typeinthecorrecttimeusingthenumber


    keys.
    d. Pressthe keytomovetoAMorPM.

    e. SelectAMorPMusingthe  keys.


    f. Pressthe keytomovetoTIMEFORMAT.

    g. SelectAM/PMor24HR.usingthe  keys.Ifselecting24HR.,thepreviouslyenteredHOUR:


    MINUTEwillchangetoa24ͲhourformatandtheAMorPMwilldisappear.

    h. Pressthe keytomovetotheDATE.


    i. Typeinthe6ͲdigitdateaccordingtotheDATEFORMATbelowit.

    j. Pressthe keytomovetotheDATEFORMAT.

    k. SelectMMͲDDͲYY,DDͲMMͲYYorYYͲMMͲDDusingthe 
    keys.ThepreviouslyenteredDATEchangesas
    theDATEFORMATchanges.

    l. Pressthe keytosavechanges.


    

    Page19of86
    Setting Default Options NewSettings
    TIMEFORMAT AM/PM AM/PM;24HR. 
    DATEFORMAT MMͲDDͲYY MMͲDDͲYY, 
    DD.MM.YY,
    YYͲMMͲDD
    
    SetUserID
    TheQuidelTriageMeterPronormallyrequiresaUserIDtobeenteredpriortorunningapatienttest,QC
    test,orMisctest,andpriortorecallingpatientresults.Refertopage31forinstructions.Alternately,this
    featuremaybebypassed.Seepage21.
    
    ChangeReferenceRanges/ThresholdsforTests:
    a. SelectSETPARAMETERSusingthe  keysandpressthe key.

    b. SelectRANGESusingthe  keysandpressthe key.

    c. Selectthetestpaneltypeusingthe  keys.

    d. Selecttheanalyteandlevelusingthe  keys.TypeinthenewvaluefortheHIGHorLOWcutoff


    asappropriate.

    e. Pressthe keytosavechanges.

    NOTE:ThelowestvalueoftheRangeorThresholdmaybedisabledforsometestpanels.Refertothe
    appropriateProductInsertforspecificinformation.

    FormoredetailsaboutRangesSettingsseepage33.
    
    ChangeTestSettings
    a. SelectSETPARAMETERSusingthe  keysandpressthe key.

    b. SelectTESTSETTINGSusingthe  keysandpressthe key.

    c. Selectthetestpaneltypeusingthe  keys.

    d. Selecttheanalyteusingthe  keys.

    e. Selectthetestsetting(ACTIV,INACT,USRA,orUSRI)usingthe  keys.

    NOTE:Theabilitytochangetestsettingsmaybedisabledforsometestsinspecificpanels.Refertothe
    appropriateProductInsertforspecificinformation.

    f. Pressthe keytosavechanges.

    FormoredetailsaboutTestSettingsseepage34.

    Page20of86
    
    ChangeQCParameters
    a. SelectSETPARAMETERSusingthe  keysandpress .

    b. SelectQCPARAMETERSusingthe  keysandpress .

    c. Selectthedesiredsettingusingthe  keysandchangethevaluetotherightofthesettingby


    usingthe  keys.
    

     Setting Default Options NewSettings


     QCDEVICEFREQ. Daily  None,8HR,Daily, 
    Weekly,Monthly
     QCSAMPLEFREQ. Monthly None,8HR,Daily, 
    Weekly,Monthly
     NUMBEROFCONTROLS 2 1or2 
    
     NUMQUANTSTDDEVS 3 2or3 

    d. Pressthe keytosavechangestoQCPARAMETERS.


    
    FormoredetailsaboutQCParametersSettingsseepage35.
    
    ChangeBypassSettings
    a. SelectSETPARAMETERSusingthe  keysandpressthe key.

    b. SelectBYPASSusingthe  keysandpressthe key.

    c. ForUSERIDselectONorOFFusingthe  keys.

    d. Pressthe keytosavechangestotheBypasssetting.

    NOTE:IfthebypassisON,theuserIDfeatureisdisabledandanyonemayrunatest.IfthebypassisOFF,theuserID
    featureisactiveandonlyauthorizedusersmayrunatest.ToInstallUserID's,seepage31.

    
    FormoredetailsaboutBypassSettingsseepage36.
    
    Priortocommencingpatienttesting,removetheSupervisorCODECHIPmodulefromthemeter,returnit
    tothestorageboxandplaceinasafeplaceforfutureuse.
    
    ThemeterisnowreadytorunQCTestsinpreparationforPatientTesting.
    
    QCTestingshouldbeperformedinthefollowingmanner:
    1. RunQCDEVICE(seepage40).
    2. RunQCSAMPLEforeachlotofdevices(seepage42).
    3. Ifappropriate,runCALIBRATIONVERIFICATIONSETasaMiscTestsampleforeachtestpaneltypetobe
    used.(RefertotheapplicableProcedureManualandCalibrationVerificationSetPackageInsertfor
    detailedinstructions).

    Page21of86
    
    Location
    TheQuidelTriageMeterProshouldbeplacedonadry,clean,flat,horizontalsurfaceawayfromdirect
    sunlight.
    
    Power
    TheQuidelTriageMeterProrequires6ͲvoltsDCsuppliedbyeitherACorDC.Themeterwillrun
    approximately100testsonbatteries.Itisrecommendedtousebatteriesasabackupintheeventofa
    poweroutage.
    

    NOTE:TheQuidelTriageMeterProwillautomaticallyturnoffifleftunusedfor2hours,unless
    programmedotherwisebythesupervisor.Optionalsettingsallowautomatedturnoffafter30minutes,
    1hour,2hours,4hoursorNONE.
    

    CAUTION:Useonlythepowersupplyprovidedwiththemeter,failuretodosomaycausepermanentdamageto
    themeter.
    
    SelfͲTest
    TheQuidelTriageMeterProchecksthesystemtobesureitisoperatingproperlybyrunningselfͲtestswhen
    poweredonandpriortoeachtest.
    „ PowerOn–includeslaseroperation,internalstandardrange,batterypower,andsoftwareverification.
    „ EachTest–verifiesthelaseroperation,internalstandardrangeandbatterypower.
    
    CODECHIPModules
    MeterdataisupdatedviaadisposableCODECHIPmodule.TheCODECHIPmodulecontainsmicrochip
    circuitryembeddedintoaplastichousing.WheninsertedintothemeterCODECHIPmoduleportand
    activated,theinformationistransferredintotheQuidelTriageMeterPro’smemory.ACODECHIPmodule
    typicallyneedstobeinstalledonlyonceandremainsinthemetermemory.ACODECHIPmoduledoesnot
    needtoremaininthemeterwhileperformingtests.
    
    TherearefivetypesofCODECHIPmoduleswhichcanbedistinguishedbyshapeorcolor.
    

    StandardCODECHIPmodule

    
    „ ReagentTestCODECHIPmodule–includedineachboxoftestdevices;containscalibration,expirationdate
    andotherdataaboutthedevicelot.(Colorvariesbytesttype.)
    „ QCSampleCODECHIPmodule–includedineachboxofQCSample;containsexpirationdateandother
    dataabouttheQCSamplelotincludingacceptablerange.(White.)
    „ QCDeviceCODECHIPmodule–includedintheblackQCDevicebox(comeswiththeQuidelTriage
    MeterPro);containsdataabouthowthemetershouldreaditsmatchingQCDevice.(Darkgray.)
    „ SupervisorAccessCODECHIPmodule–includedwitheachQuidelTriageMeterPro;containscodeto
    activateSupervisorfunctions.(Lightgray.)
    

    Page22of86
    
    
    „ SoftwareUpgradeCODECHIPmodule–providedwhenQuidelTriageMeterProsoftwareupgradesare
    available;containsnewsoftwareforthemeter.
    
    
    SetParameters
    Purpose
    TheSETPARAMETERSfunctionallowsthesupervisortoselectanumberofsettings.Accesstothesesettings
    iscontrolledusingtheSupervisorCODECHIPmodule.
    
    ListofProgrammableParameters
    Asupervisorcansetthefollowingparameters:

    Heading Parameters
    IDSETTINGS NumberofCharactersinUserID,NumberofCharactersinPatient
    ID,NumberofCharactersinAuxiliaryID,EnableorDisable
    AuxiliaryID,NumberofCharactersinMiscTestID
    DISPLAYSETTINGS Language,PrinterMode,AutoPowerͲOff,DisplayContrast,
    PrinterContrast
    COMMUNICATIONS BaudRate,EnableorDisableLIS,EnableorDisableAutoUpload,
    EnableorDisablePatientResultApproval
    CLOCK Time,Date,andDisplayFormat
    USERID AddNewUserID,UpdateUserID,DeleteUserIDorUserIDList

    RANGES  TestCutoffs
    TESTSETTINGS BlockAnalytes
    QCPARAMETERS MinimumFrequencyforQCTests,NumberofControls,Number
    ofStandardDeviations(QuantitativeTests)
    BYPASS DisableUserIDrequirement

    
    SupervisorAccess
    ASupervisorCODECHIPmoduleisshippedwitheachmeter.Installing
    theCODECHIPmodulegivesthesupervisoraccesstotheSET
    PARAMETERSandDELETERESULTSfunction.

    Page23of86
    ToinserttheSupervisorCODECHIPmoduleintotheQuidelTriageMeterPro,slidethechiplabeled"SPR"
    intothemeter’sCODECHIPmoduleportasshowninthepicture.
    
    
    
    HowtoSetParameters:BasicInstructions
    
    Allinstructionsassume:
    
    „
     Themeterison.
    „
     Themeterscreenisdisplayingthemainmenu.
    „ TheSupervisorCODECHIPmoduleisinstalled.
    
    1.
     SelectSETPARAMETERSusingthe  keys.
    
    2. Pressthe key.
    
    3.
     Youwillseealistofprogrammableparameters.
    
    
    
    METERSETTINGS 
    CLOCK
     USERID
     RANGES
     TESTSETTINGS
    QCPARAMETERS
     BYPASS
     
    SELECTWITHvOR^ANDPRESSENTER
    
    ORPRESSEXIT
    
    TheSetParametersMenu
     
    4. Usethe  keystoselecttheparameteryouwanttoprogram:
     METERSETTINGS,CLOCK,USERID,RANGES,TESTSETTINGS,QCPARAMETERS,orBYPASS.
    
    5. Pressthe key.
    6. Followthedirectionsforsettingtheselectedparameter(seethenextsection).
    
    
     NOTE:Tosavechanges,presstheENTERkey.Tocancelchanges,presstheEXITkey.Wheneitherthe
    ENTERortheEXITkeysarepressed,themeterperformstheappropriatefunctionandreturnstothe
     previousmenu.
    
    
     

    
    
    
    

    
    
    
    
    Page24of86
    
    
    
    MeterSettings „ MainMenu
    Thismenuwillallowyoutosetbasicoperationalcriteriaforthemeter:language, „ SetParameters
    displaycontrast,maximumlengthoftheuser,patient,auxiliaryandmisc.ID's, „ MeterSettings
    printermodeandautomaticpoweroff. „ IDSettings
    

    IDSettings „ MainMenu
    CharactersUserID „ SetParameters
    Thissettingwillsettheminimumandmaximumnumberofcharactersin „ MeterSettings
    theUserID. „ IDSettings
    

    1. Fromalistofprogrammableparameters,chooseINSTRUMENTSETTINGSusingthe  keys.

    2. Pressthe key.

    3. Usethe  keystoselectIDSETTINGS.

    4. Pressthe key.

    5. Usethe  keystoselectthenumbertotherightofCHARACTERSUSERIDundertheMIN


    column.

    6. Usethe  keystochoosethesmallestnumberofcharactersthatwillappearintheUserID.The


    minimumnumberofcharacterspossibleis1.
    7. Usethe keytoselectthenumbertotherightofCHARACTERSUSERIDundertheMAXcolumn.

    8. Usethe  keystochoosethelargestnumberofcharactersthatwillappearintheUserID.The


    maximumnumberofcharacterspossibleis16.

    9. Pressthe keytosavechanges.


    
    CharactersPat.ID
    

    ThissettingwillsettheminimumandmaximumnumberofcharactersinthePatientID.
    1. Fromalistofprogrammableparameters,chooseINSTRUMENTSETTINGSusingthe  keys.
    2. Pressthe key.
    3. Usethe  keystoselectIDSETTINGS.
    4. Pressthe key.
    5. Usethe  keystoselectthenumbertotherightofCHARACTERSPAT.IDundertheMINcolumn.
    6. Usethe  keystochoosethesmallestnumberofcharactersthatwillappearinthePatientID.
    Theminimumnumberofcharacterspossibleis1.
    7. Usethe keytoselectthenumbertotherightofCHARACTERSPAT.IDundertheMAXcolumn.
    8. Usethe  keystochoosethelargestnumberofcharactersthatwillappearinthePatientID.The
    maximumnumberofcharacterspossibleis20.

    Page25of86
    9. Pressthe keytosavechanges.
    
    CharactersAux.ID „ MainMenu
    ThissettingwillsettheminimumandmaximumnumberofcharactersintheAuxID. „ SetParameters
    IfthesettingofAUX.IDENABLE/DISABLEisENABLED,anAuxiliaryIDismandatoryfor „ MeterSettings
    eachpatienttest. „ IDSettings
    
    1. Fromalistofprogrammableparameters,chooseMETERSETTINGSusingthe  keys.
    
    2.
     Pressthe key.

    3. Usethe  keystoselectIDSETTINGS


    
    4. Pressthe key.
    5.
     Usethe  keystoselectthenumbertotherightofCHARACTERSAUX.IDundertheMIN
     column.
    
    6. Usethe  keystochoosethesmallestnumberofcharactersthatwillappearintheAuxiliaryID.
    
     Theminimumnumberofcharacterspossibleis1.
    
    7.
     Usethe keytoselectthenumbertotherightofCHARACTERSAUX.IDundertheMAXcolumn.
    8. Usethe  keystochoosethelargestnumberofcharactersthatwillappearintheAuxiliaryID.
    
     Themaximumnumberofcharacterspossibleis12.
    
    9.
     Pressthe keytosavechanges.
    
    
    NOTE:TheAuxiliaryIDisshownonlyontheNewResultdisplayorprintout.Itisnotvisibleinrecalled
    
    results.Trackingmaybemanagedthroughtheoptionalsoftwarepackage,QuidelTriageCensus.
    
    
    

    Aux.IDEnable/Disable „ MainMenu
    ThissettingwillturnonorturnofftheAuxiliaryIDfunction.TheAuxiliaryIDmaybe „ SetParameters
    usedforrecordingatestordernumber,physicianIDorotherspecializedidentifying „ MeterSettings
    information. „ IDSettings

    1. Fromalistofprogrammableparameters,chooseMETERSETTINGSusingthe  keys.


    2. Pressthe key.
    3. Usethe  keystoselectIDSETTINGS.
    4. Pressthe key.
     Usethe
     keystoselectthewordtotherightofAUX.IDENABLE/DISABLE.
     Usethe keystochooseDISABLEDorENABLED.IfDISABLEDisselected,theAuxiliaryID
    
    promptscreenswillneverappear.IfENABLEDisselected,anAuxiliaryIDismandatoryforeachpatient
    test.
    7. Pressthe keytosavechanges.
    
    
    

    
     Page26of86
    
    
    
    CharactersMisc.ID
    ThissettingwillsettheminimumandmaximumnumberofcharactersintheMisc.TestID.
     Fromalistofprogrammableparameters,chooseINSTRUMENTSETTINGSusingthe  keys.

    2. Pressthe key.

    3. Usethe  keystoselectIDSETTINGS.

    4. Pressthe key.

    5. Usethe  keystoselectthenumbertotherightofCHARACTERSMISC.IDundertheMin


    column.

    6. Usethe  keystochoosethesmallestnumberofcharactersthatwillappearintheMISC.TEST


    ID.Theminimumnumberofcharacterspossibleis1.

    7. Usethe keytoselectthenumbertotherightofCHARACTERSMISC.IDundertheMAXcolumn.

    8. Usethe  keystochoosethelargestnumberofcharactersthatwillappearintheMISC.TESTID.


    Themaximumnumberofcharacterspossibleis20.

    9. Pressthe keytosavechanges.


    
    
    DisplaySettings „ MainMenu
    Language „ SetParameters
    Thissettingwilldeterminewhichlanguagethemeterdisplaysandprints. „ MeterSettings
     „ DisplaySettings
    
    1. Fromalistofprogrammableparameters,chooseMETERSETTINGSusingthe  keys.
    2. Pressthe key.
    3. Usethe  keystoselectDISPLAYSETTINGS.
    4. Pressthe key.
    5. Usethe  keystohighlightthenametotherightofLANGUAGE.
    6. Usethe  keystochangethelanguageoftheQuidelTriageMeterPro’sscreenandprintouts.
    7. Pressthe keytosavechanges.
    
    PrintMode
    Thissettingwilldetermineifthemeterprintsautomaticallyoronlywhenrequested.
    
    1. Fromalistofprogrammableparameters,chooseMETERSETTINGSusingthe  keys.
    2. Pressthe key.

    Page27of86
    3. Usethe  keystoselectDISPLAYSETTINGS.
    4. Pressthe key.
    5. Usethe  keystoselecthighlightthewordtotherightofPRINTMODE.
    6. Usethe  keystochooseAUTOMATICorMANUAL.IfAUTOMATICisselected,themeterwill
    immediatelyprintouttheresultsaftereachtest(patient,QCorMiscTest).IfMANUALisselected,the
    usermustusethe buttononthekeypadtoprintoutresults.
    7. Pressthe keytosavechanges.
    
    „ MainMenu
    AutoPower–Off
    „ SetParameters
    Thissettingwilldeterminethelengthoftimebeforeaninactivemeter
    „ MeterSettings
    willpoweroff.
    „ DisplaySettings
    
    

    1. Fromalistofprogrammableparameters,chooseMETERSETTINGSusingthe  keys.


    2. Pressthe key.
    3. Usethe  keystoselectDISPLAYSETTINGS.
    4. Pressthe key.
    5. Usethe  keystoselectthevaluetotherightofAutoPowerͲOff.
    6. Usethe  keystochoosethedesiredtimersettingforthemetertopoweritselfoffwhennotin
    use.Thechoicesare:1/2HOUR,1HOUR,2HOURS,4HOURSorNONE.IfNONEisselected,themeter
    mustbemanuallyshutoffusingtheON/OFFkey.
    7. Pressthe keytosavechanges.

    NOTE:Whenpoweredonlybybatteries,select1/2hourtoconservebatterylife.Certainscreens,whendisplayed,
    willnotautomaticallypoweroff.TheNewResultsscreenisanexample.
    .
    DisplayContrast
    Thissettingwilladjustthedisplaycontrast.
    1. Fromalistofprogrammableparameters,chooseMETERSETTINGSusingthe  keys.
    2. Pressthe key.
    3. Usethe  keystoselectDISPLAYSETTINGS.
    4. Pressthe key.
    5. Usethe  keystoselectthenumbertotherightofContrast.
    6. Usethe  keystochangethecontrastofthemeter’sscreen.Therangeisfrom0–8(8beingthe
    greatestcontrast).
    7. Pressthe keytosavechanges.
    

    Page28of86
    
    
    PrinterContrast „ MainMenu
    Thissettingwilladjusttheprintercontrastformeterswithaserialnumber „ SetParameters
    29901orgreater. „ MeterSettings
     „ DisplaySettings
    
    1. Fromalistofprogrammableparameters,chooseMETERSETTINGSusingthe  keys.
    2. Pressthe key.
    3. Usethe  keystoselectPRINTERCONTRAST.
    4. Pressthe key.
    5. Usethe  keystoselectthenumbertotherightofContrast.
    6. Usethe  keystochangethecontrastofthemeter’sscreen.Therangeisfrom0Ͳ8(8beingthe
    greatestcontrast).
    7. Pressthe keytosavechanges.
    
    CommunicationSettings
     „ MainMenu
    PriortoactivatingtheLISfeature,obtainthemeter’sserialnumberlocated
    „ SetParameters
    underneaththemeterandcontactQuidel(RefertotheAssistancesection).
    „ MeterSettings
    TheQuidelRepresentativewillprovideyouwithapasswordthat,whenentered,
    „ CommSettings
    willallowdatatobetransmitted.
    
    BaudRate
    1. 
    1. Fromalistofprogrammableparameters,chooseMETERSETTINGSusingthe  keys.
    1. 
    2.
    1. Pressthe
     key.
    3. Usethe  keystoselectCOMMSETTINGS.
    4. Pressthe key.
    5. Usethe  keystoselectBAUDRATE.
    6. Usethe  keystochoose9600or38400.
    7. Pressthe key.
    
    PatientResultApproval
    Someinstitutionsmaywishforpatienttestresultstobeverifiedbytheuser „ MainMenu
    beforeprintingorsendingtotheLIS.Activationofthisfeaturedisplaystheresult, „ SetParameters
    thenrequirestheusertoacceptorrejecttheresultbeforetherecordisprinted „ MeterSettings
    andsaved.Ifthetestisrejected,themeterwillpermanentlyflagitasrejected „ CommSettings
    bytheuser.
    
    1. Fromalistofprogrammableparameters,chooseMETERSETTINGSusingthe  keys.
    2. Pressthe key.

    Page29of86
    3. Usethe  keystoselectCOMMSETTINGS.

    4. Pressthe key.

    5. Usethe  keystoselectPAT.RESULTAPPROVAL.

    6. Usethe  keystochooseDISABLEDorENABLED.

    7. Pressthe key.

    Whenenabled,afterapatientresultisavailableanddisplayedonthemeterscreen,theusermustacceptor
    rejecttheresultbeforeprinting,uploadingorperforminganyothermeterfunctions.
    
    ThemeterpromptstheusertoPRESS1TOACCEPTOR0TOREJECT.Oncethetesthasbeenacceptedor
    rejected,themeteroperatesnormally.
    
    Ifthetesthasbeenrejected,thedisplayandprintoutwillbeflaggedwithPAT.RESULTREJECTEDor
    RESULTSREJECTEDBYUSER.RecalledresultswilldisplayanRbeforethepatientIDintherejectedrecord.
    
    
    LISEnable „ MainMenu
    1. Fromalistofprogrammableparameters,chooseMETERSETTINGS „ SetParameters
    usingthe  keys. „ MeterSettings
    2. Pressthe key. „ CommSettings
    3. Usethe  keystoselectCOMMSETTINGS.
    4. Pressthe key.
    5. Usethe  keystoselectLIS.
    6. Usethe  keystochooseDISABLEDorENABLED.
    7. Pressthe key.
    8. IfDISABLEDwasselected,ascreenshowingaLISDISABLEDwillappear.Press
    the key.
    9. IfENABLEDwasselected,ascreenshowingaENTERLISPASSWORDwillappear.Enterthepassword
    providedbytheQuidelRepresentative.Pressthe key.
    10.AcknowledgetheLISENABLEDmessagebypressingthe key.
    
    AutoUpload
    (ThisfeatureisvisibleaftertheLIShasbeenenabled)
    1. Fromalistofprogrammableparameters,chooseMETERSETTINGSusingthe  keys.
    2. Pressthe key.
    3. Usethe  keystoselectCOMMSETTINGS.
    4. Pressthe key.
    5. Usethe  keystoselectAUTOUPLOAD.
    6. Usethe  keystochooseENABLEDorDISABLED.
    7. Pressthe key.

    Page30of86
    
    Clock „ MainMenu
    Theclockmenusetsthetimeanddateofthemeterandtheformatfordisplaying „ SetParameters
    both.Ifthemeterhaslostpower,thetimeanddatewillblinkontheMainMenu. „ Clock
    
    1. Fromthelistofprogrammableparameters,chooseCLOCKusingthe  keys.

    2. Pressthe key.

    3. Usethe  keystoselecttheHOUR:MINUTEarea.Usingthekeypad,typeinthecorrecttime.


    Thenumbersyoutypewillappearfromtherightandmoveleftasyoucontinuetotype.

    4. Press tomovetoAMorPM.Ifthe24HR.formathasbeenpreviouslyselected,theAMorPMwill


    notbevisableandtheTIMEFORMATwillbehighlighted.Proceedtostep7below.

    5. SelectAMorPMusingthe  keys.

    6. Press tomovetoTIMEFORMAT.

    7. Usethe  keystoselectAM/PMor24HR.Ifselecting24HR.,thepreviouslyenteredHOUR:


    MINUTEwillchangetoa24ͲhourformatandtheAMorPMwilldisappear.

    8. Press tomovetotheDATE.


    9. Usingthekeypad,typeinthe6ͲdigitdateaccordingtotheDATEFORMATbelowit.

    10. Press tomovetotheDATEFORMAT.


    11. Usethe  keystoselectMMͲDDͲYY,DDͲMMͲYYorYYͲMMͲDD.ThepreviouslyenteredDATE
    changesastheDATEFORMATchanges.
    12. Press tosavechanges.

    NOTE:IfyouhaveselectedAM/PM,AMorPMappearsafterthetime,asappropriate.
    
    UserID
    „ MainMenu
    Upto600UserID'swith1–16charactersmaybeprogrammedintothemeter.
    „ SetParameters
    TheUserIDmayalternatelybeenteredusingtheexternalBarCodeScanner
    „ UserID
    (optional).
    
    AnadditionalsecurityfeatureoftheUserIDisthepartialmaskingoftheIDondisplaysandprintouts.This
    preventsunauthorizedindividualsfromdetectingandusinganexistingUserID.WhentheSupervisorCODE
    CHIPmoduleisinstalledinthemeter,thisfeatureisoverriddenandallUserIDcharactersaredisplayed.
    
    NewUserID
    1. Fromthelistofprogrammableparameters,chooseUSERIDusingthe  keys.
    2. Pressthe key.
    3. SelectNEWUSERIDusingthe  keys.
    4. Pressthe key.

    Page31of86
    5. TypeinaUserIDwithanumberofcharacterswithinMINCHARACTERSUSERIDandMAXCHARACTERS
    USERID.Tocorrect,press tocleartheentireID,orselecttheincorrectcharacterbyusingthe 
    keys.ThentypeinthecorrectID.
    6. Pressthe key.
    7. Onthenextscreen,usethe  keystoselectanexpirationdatetotherightofUSERIDSTATUS:6
    MONTHS,12MONTHS,VALIDorEXPIRED.
    8. Pressthe keytosavechanges.
    
    NOTE:UserID9999999999(10Ͳ9’s)isadefaultsettingdisplayedwhentheUserIDBypassisonorwhena
    testisrunwiththeSupervisorCODECHIPmoduleinstalled.
    
    
    
     NOTE:IfyoutypeinaUserIDthathasalreadybeenassigned,themessageonthescreenstates:
     USER###ALREADYEXISTS.PressENTERtogobackandtypeinadifferentID
    
    TheQuidelTriageMeterProrecognizes0’sasauniquecharacter.Therefore,‘4341’willberecognized
    separatelyfrom‘04341’.
    
    Usingthebarcodescanneroralphamode(shiftkey)willallowtheQuidelTriageMeterProtoacceptalpha
    charactersandthefollowingsymbols:#()*Ͳ./\
    
    UpdateUserID „ MainMenu
    1. Fromthelistofprogrammableparameters,chooseUSERIDusingthe „ SetParameters
    keys. „ UserID
    
    
    2. Pressthe key.
    3. SelectUPDATEUSERIDusingthe  keys.
    4. Pressthe key.
    5. TypeintheuserIDyouwanttoupdate.Tocorrect,press tocleartheentireID,orselectthe
    incorrectcharacterbyusingthe  keys.ThentypeinthecorrectID.
    6. Pressthe key.
    7. TheuserIDisdisplayedwiththeexpirationdate.Youcanchangetheexpirationdateto6MONTHS,12
    MONTHS,EXPIREDorVALIDbyusingthe  keys.VALIDreconfirmsthepreviouslyselected
    interval.
    8. Pressthe keytosavechanges.
    
    NOTE:IfyoutypeinaUserIDthatdoesnotexist,themessageonthescreenstates:USERID###DOES
    NOTEXIST.Ifthishappens,pressENTERtoreturntothepreviousscreenandcorrecttheID,orpresstheEXITkey.

    
    DeleteUserID
     Fromthelistofprogrammableparameters,chooseUSERIDusingthe  keys.

     Pressthe key.

    Page32of86
     SelectDELETEUSERIDusingthe  keys.
     Pressthe key.
     TypeintheuserIDtobedeleted.Tocorrect,press tocleartheentireID,orselecttheincorrect
    characterbyusingthe  keys.ThentypeinthecorrectID.
     Pressthe key.Themessageonthescreenstates:USERID###WILLBEDELETED.
     Pressthe keytodelete.AmessageonthescreentellsyouthattheIDhasbeendeleted:USERID
    ###DELETED.
    
    
    NOTE:
     IfyoutypeinaUserIDthatdoesnotexist,themessageonthescreenstates:USERID###DOESNOT
     EXIST.Ifthishappens,pressENTERtoreturntothepreviousscreenandcorrecttheID,orpresstheEXITkey.
    
    UserIDList „ MainMenu
    1. Fromthelistofprogrammableparameters,chooseUSERIDusing „ SetParameters
    the  keys. „ UserID
    2. Pressthe key.
    3. SelectUSERIDLISTusingthe  keys.
    4. Pressthe key.
    5. Alistisdisplayed.
    6. Usethe  keystoselectthetypeofIDlistyouwant:USERID,FROMEXPIRATIONDATE,TILL
    EXPIRATIONDATE.
    „ ForalistofallID's,selectUSERID.

    „ ForasingleID,selectUSERIDandtypeintheID.Tocorrect,press tocleartheentireID,or
    selecttheincorrectcharacterbyusingthe  keys.ThentypeinthecorrectID.

    „ ForarangeofID's,entertheFROMand/ortheTOdates.Thedatesareenteredbytypingthemonth
    number,thedaynumberandtheyearnumberintheformatyouhavechosen.Thenumbersyou
    typewillappearfromtherightandmoveleftasyoucontinuetotype.Tocorrect,press toclear
    theentiredate.Thentypeinthecorrectdate.

    7. Pressthe key.


    8. Toprintthelistyouhavechosen,press .
    
    Ranges
    Dependingonthepaneltype,therangeonthedisplayandprintoutwillbe „ MainMenu
    titledREFERENCERANGESorTHRESHOLDS.Thelowend,whenthetestdisplays „ SetParameters
    thresholds,issetto‘0’andisunchangeable.
    
    Someanalytesaredesignedforthreedistinctranges.Themeterdistinguishesbetweentworangeandthree
    rangeanalytesinthesetupscreenbydifferentiatingthesymbolbetweentheloweranduppervalues.
    
    „ Analyteswithadash–Tworanges.Thenormalrangeisanyvaluebetweenthetwonumbersdisplayed.
    Dependingontheproduct,thenormalrangemaybeinclusiveorexclusiveoftheuppernumber.Consult

    Page33of86
    theproductpackageinsertorcontactQuidelforclarification.Thesevalueswillbeinreversevideoon
    thepatientresults.
    „ Analyteswithacomma–Threerangespossible.Ifthelowernumberis0.0,themetertreatsthe
    analyteashavingonlytworanges.Ifthelowernumberisnot0.0,thenormalrangeisanyvalueless
    thanthelowernumber.Thefirstabnormalrangeisanyvaluebetweenthetwonumbersandisinclusive
    ofthesenumbers.Thesevalueswillbeboxedonpatientresults.Thesecondabnormalrangeisanyvalue
    greaterthantheuppernumber.Thesevalueswillbeinreversevideoonpatientresults.Consultthe
    productpackageinsertorcontactQuidelforclarification.
    
    1. Fromthelistofprogrammableparameters,chooseRANGESusingthe  keys.
    2. Pressthe key.
    3. Selectthetestpaneltypeusingthe  keys.
    4. Selecttheanalyteandlevelusingthe  keys.TheHIGHandLOWvalueforeachoftheanalytes
    canbechangedusingthekeypadtotypeinthevalues.Tocorrect,press tocleartheentirenumber.
    Thentypeinthecorrectnumber.

    5. Pressthe keytosavechanges.

    NOTE:Thefieldwillbedisabledifthepanelsettingisfixed.Consultthespecificpanelpackageinsertto
    determineifthesettingmaybechanged.

    
    TestSettings
    Incertaincases,thelabsupervisormaywishtocontrolwhichtestsareavailable „ MainMenu
    toberunatthetimeofpatienttesting.Theoptionsare: „ SetParameters
    1. ACTIVE(ACTIVONSCREEN):Thetestisalwaysrunandcannotbedeselected.
    2. INACTIVE(INACTONSCREEN):Thetestisneverrunandisnotdisplayed.
    3. USERINACTIVE(USRIONSCREEN):Thetestcanbeselectedbytheuseratthetimeofrunningthetest.
    4. USERACTIVE(USRAONSCREEN):Thetestcanbedeselectedbytheuseratthetimeofrunningthetest
    
    Iftheseoptionsarenotavailableforatest,themeterskipsoverthesettingasthesupervisorscrollsthrough
    theoptions.Seepage45formoredetails.
    
    1. Fromthelistofprogrammableparameters,chooseTESTSETTINGSusingthe
    1. keys.
    1. 
    2.
    1. Pressthe
     key.
    3.
    1. Selectthetestpaneltypeusingthe  keys.
    1.
    4. Selecttheanalyteusingthe keys.
    1.  
    5. Selectthedesiredmodeusingthe
    1.  keys.
    1. „ ACTIVE(ACTIVONSCREEN)–Thetestwillrunoneverypatientspecimen.
    1. „ INACTIVE(INACTONSCREEN)–Thetestwillneverrunonapatientspecimenandisdroppedfrom
    1.  alldisplaysandprintouts.
    1. 
    1. „ USERINACTIVE(USRIONSCREEN)–Atthetimeofpatienttesting,theuserhastheabilitytoselect
    1.  thetest.
    1.
    1. 

    Page34of86
    „ USERACTIVE(USRAONSCREEN)–Atthetimeofpatienttesting,theuserhastheabilityto
    deselectthetest.

    6. Pressthe keytosavechanges.

    NOTE:Whentheanalyteisdeselected,thevalueisnotcalculatednorstored

    
    QCTestsWithTestSettingsActivated
    AnytestwhichtheSupervisorhassettoACTIVE,USERACTIVEorUSERINACTIVEwillrunontheQCSample
    panel.Themeterwilldisplayandprintthetest’sQCsampleresultandupdatetheQCSampletimerforthe
    test.IftheSupervisorhassetthetesttoINACTIVE,thetestwillhavetheQCSampleturnedOFF.TheQC
    Sampleresultwon’tshowforthattestandtheQCSampletimerwon’tbeupdatedforit.
    
    IftheSupervisorchangesthetestfromINACTIVEtoACTIVE,toUSERACTIVEortoUSERINACTIVEthattest
    maybeoutofQCSampledate.AsalwaysforatestwithanexpiredQCSample,apassingQCSampletestwill
    needtorunbeforeapatientsamplecanreportaresultforthattest.
    
    QCParameters
    TheQCParametersmenuprovidestheusertheoptionsfordeterminingwhatthe
    „ MainMenu
    maximumfrequencyisforrunningtheQCDeviceandQCSample,whether1or2
    „ SetParameters
    levelsofcontrolarerequiredfortheQCSample,andwhethertheallowedQC
    „ QCParameters
    SampleRangeofquantitativetestsis2or3standarddeviations.
    
    QCDeviceFrequency
    TheQCDEVICEFREQUENCYsettingdeterminesthemaximumintervalbetweenQCDeviceteststhatauser
    isallowedtorunpatienttests.Whentheintervalhaslapsed,allusersarelockedoutoftheRunTestmenu
    untilaQCDevicehasbeensuccessfullyrun.

    ItisrecommendedthattheQCDeviceberundailywhenperformingpatienttesting.

    1. Fromthelistofprogrammableparameters,chooseQCPARAMETERSusingthe  keys.


    2. Pressthe key.
    3. Usethe  keystoselecttheinformationtotherightofQCDEVICEFREQ.
    4. Usingthe  keys,selectoneoftheseoptions:NONE,8HOURS,DAILY,WEEKLY,MONTHLY.
    5. Pressthe keytosavechanges.
    
    QCSampleFrequency
    TheQCSAMPLEFREQUENCYsettingdeterminesthemaximumintervalbetweenQCSampleteststhatauser
    isallowedtorunpatienttestsonaparticulardevicelotnumber.Whentheintervalhaslapsed,allusersare
    lockedoutoftheRUNPATIENTTESTmenuuntilaQCSamplehasbeensuccessfullyrun.Toviewwhena
    particulardevicelot’sQCSamplewillexpire,usetheRECALLREAGENTLOTS–QCfeature.
    
    ItisrecommendedthattheQCSampleberunwitheverynewshipment,newlotormonthly,whicheveris
    lesswhenperformingpatienttesting.

    Page35of86
    1. Fromthelistofprogrammableparameters,chooseQCPARAMETERSusingthe  keys.
    2. Pressthe key.
    3. Usethe  keystoselecttheinformationtotherightofQCSAMPLEFREQ.
    4. Usingthe  keys,selectoneoftheseoptions:NONE,8HOURS,DAILY,WEEKLY,MONTHLY.
    5. Pressthe keytosavechanges.
    

    NumberofControls „ MainMenu
     Fromthelistofprogrammableparameters,chooseQCPARAMETERS „ SetParameters
    usingthe keys. „ QCParameters
    

    2. Pressthe key.


    3. Usethe  keystoselecttheinformationtotherightofNumberofControls.
    4. Usingthe  keys,selectoneoftheseoptions:1or2.
    5. Pressthe keytosavechanges.

    NumberofControlStandardDeviationsforQuantitativeTests
    1. Fromthelistofprogrammableparameters,chooseQCPARAMETERSusingthe  keys.

    2. Pressthe key.

    3. Usethe  keystoselecttheinformationtotherightofNUMQUANTSTDDEVS.

    4. Usingthe  keys,selectoneoftheseoptions:2or3.

    5. Pressthe keytosavechanges.

    BypassUserID „ MainMenu
    Thisfunctionallowsthesupervisortoselectivelybypasstherequirementtoenter „ SetParameters
    auserIDbeforeperforminganytest. „ Bypass
    
    1. Fromthelistofprogrammableparameters,chooseBYPASSusingthe keys.
    
    
    2. Pressthe key.
    3. SelectUSERIDusingthe  keys.

    4. Usethe  keystoselectfromtwooptions:ONorOFF.

    5. Pressthe key.


    
    
    
    NOTE:IfthebypassisON,theUserIDrequirementisdisabledandthereforenotrequired.Whenthe
    
    bypassisOFF,theUserIDrequirementoperatesasnormalandisrequired. 
    
    
    

    Page36of86
    InstallCodeChip
    Purpose
    TheQuidelTriageMeterProwillprompttheusertoinstallaCODECHIPmodulewhenrequired.However,
    theINSTALLCODECHIPfunctionmaybeusedasanalternatemethodtotransferinformationfromaCODE
    CHIPmoduleintothemeter’smemory.ThemeterwilldirecttheusertoinstallaCODECHIPmoduleifitis
    attemptingtorunatestanddoesnothavethedatainitsmemory.
    
    TypesofCODECHIPmodules
    TherearefivetypesofCODECHIPmodules
    

    „ ReagentCODECHIPmodule–includedineachboxoftest
    devices.LotnumberbeginswithaW.

    „ QCSampleCODECHIPmodule–includedineachboxof
    controls.LotnumberbeginswithaC.

    
    „ QCDeviceCODECHIPmodule–includedintheblackQC
    Devicebox(comeswiththeQuidelTriageMeterPro)andis
    labeledwiththeserialnumberoftheQCDevice.

    „ SupervisorAccessCODECHIPmodule–includedwitheach
    QuidelTriageMeterPro.LotNumberbeginswithSPR.

    „ SoftwareUpgradeCODECHIPmodule–sentseparately
    whenQuidelTriageMeterProsoftwareupgradesare
    available.

    
    
    

    CAUTION:RunningtestswiththeSupervisorCODECHIPmoduleinstalleddisablesallQC
    Lockouts.RemovetheSupervisorCODECHIPmodulepriortorunningtests.
    
    InstallationofReagent,QCSampleorQCDeviceCODECHIPModules
    InstallCodeChip
    1. FromtheMainMenuselectINSTALLCODECHIPusingthe keys. „ MainMenu
    
    2. Pressthe key.

    Page37of86
    3. SlidetheCODECHIPmoduleintotheCODECHIPmodulePortintheQuidelTriageMeterPro,asshownin
    thepicture.

    4. Pressthe key.


    5. ThemeterwilldisplayaconfirmationmessagethattheinformationwasinstalledintotheQuidelTriage
    MeterPro’smemory.

    6. Press toreturntoacknowledgethemessage.


    7. RemovetheCODECHIPmodulefromtheCODECHIPmodulePort.
    8. PlacetheCODECHIPmodulebackintoitsoriginalcontainerforstorage.

    INSTALLATIONOFSUPERVISORCODECHIPMODULE
    TheSupervisorCODECHIPmoduleneedsonlytobeinsertedintotheCODECHIPmodulePorttoactivatethe
    supervisorfunctions.ThisisanautomaticfunctionandstandardCODECHIPmoduleinstallationisnot
    necessary.
    

     

    Page38of86
    Operation
    AccesstotheQuidelTriageMeterPro
    Function Use Restrictedto
    RUNTEST PatientTesting OperatorswithvalidUserID's*
    QualityControlTesting OperatorswithvalidUserID's*
    Misc.TestTesting OperatorswithvalidUserID's*
    RECALLRESULTS LastRecord Iflasttestrunisapatientsample:
    OperatorswithvalidUserID's*
    Otherwise:Norestriction
    PatientTestResults OperatorswithvalidUserID's*
    QualityControlResults NoRestriction
    Misc.TestResults NoRestriction
    INSTALLCODECHIPS TypesofCODECHIP IfCODECHIPmoduleissoftware
    modules upgrade:
    Supervisor
    InstallationProcedure Otherwise:Norestriction
    SETPARAMETERS AccessControl Supervisor
    ProgrammableSettings Supervisor
    DELETERESULTS PatientTestResults Supervisor
    *UnlessUserIDisbypassedortheSupervisorCODECHIPmoduleisinstalled.

     IMPORTANT:Thelasttwofunctions,SETPARAMETERS,andDELETERESULTS,appearonthemain
    menuonlywhentheSupervisorCODECHIPmoduleisinsertedintotheCODECHIPmodulePort.The
    SupervisorCODECHIPmoduleshouldberemovedfromthemeterduringroutinepatient,quality
    control,andMisc.testing.
    

    NOTE:Accesstovariouspartsofthesoftwareisuser(institution)defined.
    
    RunTest
    Purpose
    RunTestisusedfortheanalysisofatest.
    
    Options
    TheRuntestfunctionallowsyoutotest:
    „ QCDevice

    Page39of86
    „ QCSample
    „ PatientSample
    „ Misc.TestSample
    Inordertorunapatientsample,themeterrequires:
    1. AvalidUserIDhasbeenentered(unlessthisfeatureisbypassedoraSupervisorCODECHIPmoduleis
    installed).Seepage31.
    2. AQCDevicehaspassedwithinthespecifiedtimeperiod.Seepage41.
    3. AQCSampleforthetestdevicelothaspassedwithinthespecifiedtimeperiod.Seepage42.
    
    Ifanyoftheseconditionsdonotexist,themeterwillnotcontinueandwillprompttheusertoperformthe
    requiredsteps.

     IMPORTANT:TheQuidelTriageMeterProwillalerttheuserifQChasnotbeenperformedforthe
    devicelotbeingtested.

    NOTE:TheSupervisorCODECHIPmoduleprovidesaccesstofunctionsthatmayoverridetheseLockouts.

    NOTE:IftheQuidelTriageMeterPro’sinternalqualitycontrol(QC)resultsareunacceptable,exclamation
    points(!)willbedisplayedonthescreenintheplaceofthepatientresults.Toobtainresultsrepeatthe
    testusinganewdevice.

    QCDevice
    TheQCDeviceshouldberunoneachdayofpatienttesting.
    
    ToruntheQCDevicetest: „ MainMenu
    „ RunTest
    1. Pressthe keytopowertheQuidelTriageMeterProon.

    2. SelectRUNTESTusingthe  keys.


     8:23AM01•20•18
    
    RUNTEST
    RECALLRESULTS
    INSTALLNEWCODECHIP
    SELECTWITHvOR^ANDPRESSENTER
    PRESSEXITTOEJECTDEVICE
    TheMainMenu
    

    3. Pressthe key.


    4. Typeinyouridentification(UserID).Tocorrect,pressthe keytocleartheentireID,orselectthe
    incorrectcharacterbyusingthe  keys.ThentypeinthecorrectID.

    NOTE:IftheUserIDbypassison,themeterwillnotaskyoutoenteraUserID.

    Page40of86
    5. Pressthe key.
    6. SelectQCDeviceusingthe  keys.
    

    PATIENTSAMPLE  “EXP”indicatesthatthe
    QCDevicereͲtest
    QCDEVICE  EXP frequencyhasexpired.
    QCSAMPLE  EXP
    MISC.TEST 
     
    SELECTWITHvOR^ANDPRESSENTER 
    PRESSEXITTOEJECTDEVICE 
    MenuscreenasitlookswhenoperatorselectsQCDevice.
     Pressthe key.
    8. GentlyinserttheQCDeviceintotheQuidelTriageMeterPrountilyoufeeltheQCDevicecatchonthe
    pinandhearanaudible‘click.’
     Pressthe key.

    NOTE:ThemeterwillprompttheusertoinstalltheQCDeviceCODECHIPmoduleiftheQCDevicehasnot
    beenrunbefore.

    
    10.TheQuidelTriageMeterPropullsintheQCDeviceandscansit.Thetest
    devicemaypartiallymoveinandoutofthemeterseveraltimes.
    11.Whenthetestiscomplete,themeterwillbeep,ejectthedeviceanddisplaytheresultsonthe
    meter’sscreen.
    12.Pressthe keytomakeaprintedcopyoftheresults.
    13.RemovetheQCDevicefromtheMeterandplaceintheQCDeviceBox.DONOTDISCARDTHE
    QCDEVICE.

    IMPORTANT:Importantinstructionsforalltests:
    a. GentlyinsertthetestdeviceintotheQuidelTriageMeterPrountilyoufeelthedevicecatchonthe
    pin.Youwillhearanaudible‘click’thattellsyouthetestdevicehasbeeninsertedproperly.
    b. Pressthe keytostartthetest.
    c. TheQuidelTriageMeterPropullsinthetestdeviceandscansit.
    d. Whenthetestiscomplete,themeterwillbeepanddisplaytheresultsonthemeter’sscreen.
    e. Pressthe keytomakeaprintedcopyoftheresults.
    

    CAUTION:Afterthetestdevicehasbeeninserted,donotpushthedeviceinfurtherorattempt
    topullitout.ThedevicemaybeejectedbyreturningtotheMainMenuandpressingtheEXIT
    key.

    Page41of86
    IMPORTANT:ImportantInstructionsforQCDevicetests:
    „ Dust,lint,fibersandothersmallparticlesmayinterferewiththeQCDevice.KeeptheQCDevicefreeof
    contaminants.
    „ TheQCDeviceislightͲsensitiveandshouldbestoredinitsblackopaquecasewhennotinuse.
    „ IftheQCDevicetestsfail,wipetheQCDevicecleanwithalintfreeclothtoremoveanyoils,dust,
    fibers,orfingerprints.DonotapplyanyliquidtotheQCDevice.Aftercleaningthedevice,repeatthe
    QCDevicetest.
    „ IftheQCDevicetestfailsafteryouhavecleanedthedevice,contactQuidel.

    QCSample „ MainMenu
    ToruntheQualityControlsample: 
    „ RunTest
    
    1. Pressthe keytopowertheQuidelTriageMeterProon.
    2. SelectRUNTESTusingthe  keys.
    
    8:23AM01•20•18
    
    RUNTEST 
    RECALLRESULTS
    INSTALLNEWCODECHIP
    
    SELECTWITHvOR^ANDPRESSENTER
    PRESSEXITTOEJECTDEVICE
    TheMainMenu
    
    3. Pressthe key.
    4. Typeinyouridentification(UserID).Tocorrect,pressthe keytocleartheentireID,orselectthe
    incorrectcharacterbyusingthe  keys.ThentypeinthecorrectID.

    NOTE:IftheUserIDbypassisON,themeterwillnotaskyoutoenteraUserID.
    
    5. Pressthe key.
    6. SelectQCSampleusingthe  keys.
    
    
    PATIENTSAMPLE
    QCDEVICE
    QCSAMPLE 
    MISC.TEST
    
    SELECTWITHvOR^ANDPRESSENTER
    ORPRESSEXIT TOEJECTDEVICE
    

    MenuscreenasitlookswhenoperatorselectsQCSample.

    Page42of86
    7. Pressthe key.
    8. EntertheQClotnumberfromthelabelonthesideofthebottlevialcontainingtheQCSample.

    NOTE:OnlyenterthefourͲdigitnumericvalueoftheQClotnumber.Donotentertheprecedingalpha
    character.

    
    9. Tocorrect,pressthe keytocleartheentirenumber.
    Thentypeinthecorrectnumber.

    NOTE:IfyouenteraQClotnumberforwhichthereisnodataintheQuidelTriageMeterPro’smemory,you
    willseeamessageonthemeter’sscreen:NOQCSampledatainmemory.
    Tocorrectthis:InstalltheQCSampleCODECHIP(seepictureonpage37).
    PressENTERtocontinue.

    10.Pressthe key.
    11.Performthetestaccordingtotheinstructionsprovidedinthepackageoftestdevicesyouareusing.
    

    IMPORTANT:Importantinstructionsforalltests:
    a. GentlyinsertthetestdeviceintotheQuidelTriageMeterPrountilyoufeelthedevicecatchonthe
    pin.Youwillhearanaudible‘click’thattellsyouthetestdevicehasbeeninsertedproperly.
    b. Pressthe keytostartthetest.
    c. TheQuidelTriageMeterPropullsinthetestdeviceandscansit.
    d. Whenthetestiscomplete,themeterwillbeepanddisplaytheresultsonthemeter’sscreen.
    e. Pressthe keytomakeaprintedcopyoftheresults.

    CAUTION:Afterthetestdevicehasbeeninserted,donotpushthedeviceinfurtherorattempt
    topullitout.ThedevicemaybeejectedbyreturningtotheMainMenuandpressingEXIT.

    12.Repeatstepsforeachqualitycontrolsample.

    IMPORTANT:ImportantinstructionsforQCSampleTests
    D Ifthetestdevice’sinternalqualitycontrol(QC)resultsareunacceptable,theresultsforthe
    affectedanalyte(s)willnotappearonthescreen(insteadwillbeflaggedwitha!symbol).
    b. IfanyoftheQCSampleresultsareoutofrange,theresultsforthatparticularanalytewillbein
    reversevideo(lighttextonadarkbackground).
    c. Apanelwithmultipleanalyteswillstillbeabletoreportpatientresultsonthoseanalyteswhich
    passedQC.AnanalytethatfailedQCwillnotbereportedonpatienttests(insteadwillbeflagged
    witha#symbol).

    Page43of86
    d. Ifanindividualanalyteisoutsidethespecifiedrange,theQuidelTriageMeterProallowstheusertorerunonlythefailed
    analyteonthenextQCSampleTest.Whenallanalyteshavepassed,theQCSampletimerissettothedateofthefirst
    passinganalyte.
    
    PatientSample „ MainMenu
    1. Pressthe keytopowertheQuidelTriageMeterProon. „ RunTest

    2. SelectRUNTESTusingthe  keys.


    
    8:23AM01•20•18
    
    RUNTEST 
    RECALLRESULTS
    INSTALLNEWCODECHIP
    
    SELECTWITHvOR^ANDPRESSENTER
    PRESSEXITTOEJECTDEVICE

    3. Pressthe key.

    4. Typeorscaninyouridentification(UserID).Tocorrect,press tocleartheentireID,orselectthe


    incorrectcharacterbyusingthe  keys.ThentypeinthecorrectID.

    5. Pressthe key.

    NOTE:IftheUserIDbypassisON,themeterwillnotaskyoutoenteraUserID.

    6. SelectPATIENTSAMPLEusingthe  keys.


    
    
    
    PATIENTSAMPLE
    QCDEVICE
    QCSAMPLE
    MISC.TEST
    
    SELECTWITHvOR^ANDPRESSENTER
    ORPRESSEXIT TOEJECTDEVICE
    
    7. Pressthe key.

    8. Typeorscanthepatient’sidentification(PatientID).Tocorrect,press tocleartheentireID,or


    selecttheincorrectcharacterusingthe  keys.ThentypeinthecorrectID.

    9. Pressthe key.

    NOTE:IftheBarCodeScannerisbeingused,simplypointthescanneratthebarcode,pressthebuttonon
    thescannerhandleandwaitforthebeep.TheIDwillappearonthedisplay

    Page44of86
    
    PatientSample
    „ MainMenu
    10.Iftheinformationiscorrect,pressthe keytoconfirmthePatientID.
    „ RunTest
    Iftheinformationisincorrect:
    
    „ SelectCORRECTPATIENTIDusingthe  keys.
    „ Pressthe key.
    „ Pressthe keytocleartheentireID,orselecttheincorrectcharacterusingthe  keys.
    ThentypeinthecorrectID.
    „ Pressthe key.
    11.IftheAUXILIARYIDfeatureisactivated,typeorscanintheID.Tocorrect,pressthe keytoclearthe
    entireID,orselecttheincorrectcharacterusingthe  keys.ThentypeinthecorrectID.
    12.Pressthe key.
    13.Preparethetestsampleandperformthetestinaccordancetotheinstructionsprovidedinthepackage
    oftestdevicesyouareusing.
    14.Ifthetestingfacilityhasauthorizedananalytetobeselectedordeselectedatthetimeofrunninga
    patienttest,theuserwillbepromptedtoselectdesiredanalytesordeselectundesiredanalytes.After
    thetestdevicehasbeenpulledintothemeter,themeterwilldisplayamessagesimilartothefollowing:
    
    SELECTTESTS
    CARDIAC
    
    —CKMB2 MYO3 —TNI
    
    PRESS^TOPAUSEOR0Ͳ9FORTEST
    PRESSENTERTOCONTINUEOREXIT
    
    Acheckmark—indicatestestswhichareselected.Example:—TNI
    Theabsenceofacheckmarkindicateswhichtestshavenotbeenselected.Example:MYO
    
     NOTE:Atleastoneanalytemustbeselectedinordertocontinuetesting.
    
    
    Anumbertotheleftofthetestindicatestestswhichcanbeselectedordeselected.
    „ Example:2MYOindicatesthatMYOiscurrentlynotselected,butcanbeselectedbypressing2onthe
    numerickeypadtodisplay2—MYO.
    „ Example:3—TNIindicatesthatTNIiscurrentlyselected,butcanbedeselectedbypressing3onthe
    numerickeypadtodisplay3TNI.
    „ Pressingthenumberagaintogglesthetestbetweenselectanddeselect.
    
    Nonumbertotheleftofthetestindicatestestswhichcannotbealtered.
    „ Example—CKMBindicatesthatCKMBisalwaysselected,andcannotbedeselected.
    f Pressthe key.
    f Iftheinformationiscorrect,pressthe keytocontinue.

    Page45of86
    f Iftheinformationisincorrect,selectCORRECTTESTusingthe  keysandpressthe key
    toreturntothelistsoftests.

    NOTE:IfnokeyispressedontheSELECTTESTSscreen,themeterwaits30secondsthenproceeds
    usingonlytheselecteddefaulttests.Then,ifnokeyispressedontheCONFIRMATIONSCREEN,the
    testproceedsafterwaiting30seconds.

    IMPORTANT: Importantinstructionsforalltests:
    a. GentlyinsertthetestdeviceintotheQuidelTriageMeteruntilyoufeelthedevicecatchonthe
    pin.Youwillhearanaudible‘click’thattellsyouthetestdevicehasbeeninsertedproperly.
    b. Pressthe keytostartthetest.
    c. TheQuidelTriageMeterPropullsinthetestdeviceandscansit.
    d. Whenthetestiscomplete,themeterwillbeepanddisplaytheresultsonthemeter’sscreen.

    e. Pressthe keytomakeaprintedcopyoftheresults.


    

    CAUTION: Afterthetestdevicehasbeeninserted,donotpushthedeviceinfurtherorattempt
    topullitout.ThedevicemaybeejectedbyreturningtotheMainMenuandpressingEXIT.
    

    IMPORTANT:Importantinstructionsforpatienttests:
    a. Ifthetestdevice’sInternalQualityControl(QC)resultsareunacceptable,theresultsforthe
    affectedanalyte(s)willnotappearonthescreen(insteadwillbeflaggedwitha!symbol).
    b. IfanyoftheQCSampleresultsforthelotbeingtestedwereoutofrange,theresultsforthat
    particularanalytewillnotappearonthescreen(insteadwillbeflaggedwitha#symbol).
    
     
    
    PAT.ID89547326 PAT.ID89547326
      

      
    BNP 15 pg/mL BNP 650 pg/mL
         
       PAT.RESULTABNORMAL 
      
    PRESS1TOACCEPTOR0TOREJECT PRESS1TOACCEPTOR0TOREJECT
    Screendisplayingpatientsresult Screendisplayingpatientsresultabovethe
    belowthecutofflevelandacceptor cutofflevels.
    
    rejectinstructions.
    

    
    

    Page46of86
    Misc.TestSample
    1. Pressthe keytopowertheQuidelTriageMeterProon. „ MainMenu
     „ RunTest
    2. SelectRUNTESTusingthe  keys.
    
    8:23AM01•20•18
    

    RUNTEST 
    RECALLRESULTS
    INSTALLNEWCODE CHIP
    

    SELECTWITHvOR^ANDPRESSENTER
    PRESSEXITTOEJECTDEVICE

    NOTE:IftheUserIDbypassisON,themeterwillnotaskyoutoenteraUserID.

    3. Pressthe key.

    4. Typeorscaninyouridentification(UserID).Tocorrect,press tocleartheentireID,orselectthe


    incorrectcharacterbyusingthe  keys.ThentypeinthecorrectID.
    5. Pressthe key.
    6. SelectMISC.TESTusingthe  keys.
    
    

    PATIENTSAMPLE
    QCDEVICE
    QCSAMPLE
    MISCTEST
    

    SELECTWITHvOR^ANDPRESSENTER
    PRESSEXITTOEJECTDEVICE
    

    NOTE:IftheBarCodeScannerisbeingused,simplypointthescanneratthebarcode,pressthebutton
    onthescannerhandleandwaitforthebeep.TheIDwillappearonthedisplay.

    7. Pressthe key.


    8. TypeorscantheMisc.Testidentification(Misc.TestID).Tocorrect,press tocleartheentireID,or
    selecttheincorrectcharacterusingthe  keys.ThentypeinthecorrectID.
    9. Pressthe key.
    10.Iftheinformationiscorrect,pressthe keytoconfirmtheMisc.TestID.
    Iftheinformationisincorrect:
    „ SelectCORRECTMISC.TESTIDusingthe  keys.
    „ Pressthe key.

    Page47of86
    „ Pressthe keytocleartheentireID,orselecttheincorrectcharacterusingthe  keys.
    ThentypeinthecorrectID.
    „ Pressthe key.
    
    11.Preparethetestsampleandperformthetestinaccordancetotheinstructions
    providedinthepackageoftestdevicesyouareusing.
    
    
    
    
    IMPORTANT:Importantinstructionsforalltests:
    a. GentlyinsertthetestdeviceintotheQuidelTriageMeteruntilyoufeelthedevicecatchonthepin.
    Youwillhearanaudible‘click’thattellsyouthetestdevicehasbeeninsertedproperly.
    b. Pressthe keytostartthetest.
    c. TheQuidelTriageMeterPropullsinthetestdeviceandscansit.
    d. Whenthetestiscomplete,themeterwillbeepanddisplaytheresultsonthemeter’sscreen.
    e. Pressthe keytomakeaprintedcopyoftheresults.
    

    CAUTION: Afterthetestdevicehasbeeninserted,donotpushthedeviceinfurtherorattempt
    topullitout.ThedevicemaybeejectedbyreturningtotheMainMenuandpressingEXIT.
    
    

    IMPORTANT:Importantinstructionsformisc.tests:
    a. Ifthetestdevice’sInternalQualityControl(QC)resultsareunacceptable,theresultsforthe
    affectedanalyte(s)willnotappearonthescreen(insteadwillbeflaggedwitha!symbol).
    
    
    
    
    
    
    
    

    Page48of86
    RecallResults
    Purpose
    RecallResultsisusedtoretrieveresultsstoredintheQuidelTriageMeterPro’smemory.
    
    Function
    TheRecallResultsfunctioncanretrievetheseresults:
    „ LastRecord „ QCResults
    „ PatientResults f QCSampleResults
    f PatientID f QCDeviceResults
    f PanelType f ReagentLots–QC
    f TestDeviceLotNumber(L/N) f ArchiveLastTest
    f UserID „ Misc.TestResults
    f FromDate „ PrintallResults
    f TillDate f PatientResults
     f QCSampleResults
    f QCDeviceResults
    f Misc.TestResults
    „ UploadResultstoLIS
    

    NOTE:Ifaresultwasrejectedbytheuser,an“R”willappearnexttotherecalledresult.

    IMPORTANT:TosafeguardtheUserIDLockout,displayedandprintedUserID'sarepartially
    masked.TheSupervisorCODECHIPmoduleisrequiredtobeinstalledtoviewthefullUserID.
    
    LastRecord „ MainMenu
    Purpose:LastRecordisusedtoretrievethetestresultsforthelasttestrun. „ RecallResults
    Toretrievethelastrecord:
    1. Pressthe keytopowertheQuidelTriageMeterProon.
    2. FromtheMAINMENUselectRECALLRESULTSusingthe  keys.
    3. Pressthe key.
    4. SelectLASTRECORDusingthe  keys.
    5. Pressthe key.
    6. Ifthelasttestrunisapatientresult,typeorscaninyouridentification(UserID).Tocorrect,press 
    tocleartheentireID,orselecttheincorrectcharacterbyusingthe  keys.Thentypeinthe
    correctID.Pressthe key.
    7. Theresultsfromthelasttestrunappearonthescreen.
    8. Usethe  keystoviewtheentirerecord.
    9. Pressthe keytomakeaprintedcopy.

    NOTE:IftheUserIDbypassisON,themeterwillnotaskyoutoenteraUserID

    Page49of86
    
    

    PatientResults
    Options:Patientresultscanberetrievedbasedonavarietyofcriteria: „ MainMenu
    „ PatientID „ RecallResults
    „ TestDeviceLotNumber(L/N)
    „ UserID
    „ FromDate
    „ TillDate
    
    „ MainMenu
    PatientID
    „ RecallResults
    ToretrieveresultsbasedonthepatientID:
    „ PatientResults
    1. Pressthe keytopowertheQuidelTriageMeterProon.
    2. FromtheMAINMENUselectRECALLRESULTSusingthe  keys.
    3. Pressthe key.
    4. SelectPATIENTRESULTSusingthe  keys.
    5. Pressthe key.
    6. Typeorscaninyouridentification(UserID).Tocorrect,press tocleartheentireID,orselectthe
    incorrectcharacterbyusingthe  keys.ThentypeinthecorrectID.

    NOTE:IftheUserIDbypassisON,themeterwillnotaskyoutoenteraUserID

    7. Pressthe key.


    8. SelectPANELTYPEusingthe  keys.
    9. Usethe  keystoselectthedesiredpanel.
    10. Choosetheresultsyouwanttosee:
    „ Ifyouwanttoseeallpatientresults,pressthe key.AllthepatientresultsintheQuidelTriage
    MeterPro’smemoryfortheselectedpanelwillbedisplayed.
    „ Forindividualpatientresults:
    a. SelectPatientIDusingthe  keys.
    b. TypeorscaninthepatientID.Tocorrect,pressthe keytocleartheentireID,orselectthe
    incorrectcharacterbyusingthe  keys.ThentypeinthecorrectID.

    c. ToselectapatientIDwithalphacharacters,usethe keytoenteralphacharacters.


    d. Pressthe key.AllresultsoftherequestedpatientIDfortheselectedpanelwillbe
    displayed.
    11. Usethe  keystoviewtheentirerecord.
    12.Pressthe keytomakeaprintedcopy.
    13.Pressthe keytouploadtheselectedresultstoLIS.

    NOTE:Youmaychoosemorethanoneoftheoptionsforrecallingresultsinordertodefinemoreprecisely
    theinformationyouwanttorecallfromtheQuidelTriageMeterPro’smemory.Whenyouchoosemultiple
    options,firstinputvaluesinallthecategoriesyouhavechosen.ThenpresstheENTERkey.

    Page50of86
    
    TestDeviceLotNumber(L/N)
    Toretrieveresultsbasedonthelotnumberofthetestdevicesused:
    

    „ MainMenu
    „ RecallResults
    „ PatientResults

    
    
    1. Pressthe keytopowertheQuidelTriageMeterProon.
    2. FromtheMAINMENUselectRECALLRESULTSusingthe  keys.
    3. Pressthe key.
    4. SelectPATIENTRESULTSusingthe  keys.

    5. Pressthe key.


    6. Typeorscaninyouridentification(UserID).Tocorrect,press tocleartheentireID,orselectthe
    incorrectcharacterbyusingthe  keys.ThentypeinthecorrectID.

    NOTE:IftheUserIDbypassisON,themeterwillnotaskyoutoenteraUserID.

    7. Pressthe key.


    8. SelectPANELTYPEusingthe  keys.
    9. Usethe  keystoselectthedesiredpanel.
    10.SelectDEVICEL/Nusingthe  keys.
    11.Todisplayallresultsfortheselectedpanel,pressthe key.
    12.Todisplayresultsspecifictoonelot,typeinthelotnumberofthetestdevice.Tocorrect,pressthe 
    keytocleartheentirenumber.Thentypeinthecorrectnumber.

    NOTE:OnlyenterthefiveͲdigitnumericvalueofthelotnumber.
    
    13.Pressthe key.
    14.Allresultsfromtestsrunontherequestedlotnumberfortheselectedpanelaredisplayed.
    15.Usethe  keystoviewtheentirerecord.
    16.Pressthe keytomakeaprintedcopy.
    17.Pressthe keytouploadtheselectedresultstoLIS.
    
    
    
    
     Page51of86
    UserID „ MainMenu
    ToretrieveresultsfromtestsrunontheQuidelTriageMeterProstartingwith „ RecallResults
    theuseryouselect: „ PatientResults
    

    1. Pressthe keytopowertheQuidelTriageMeterProon.


    2. FromtheMAINMENUselectRECALLRESULTSusingthe  keys.
    3. Pressthe key.
    4. SelectPATIENTRESULTSusingthe  keys.
    5. Pressthe key.
    6. Typeorscaninyouridentification(UserID).Tocorrect,press tocleartheentireID,orselectthe
    incorrectcharacterbyusingthe  keys.ThentypeinthecorrectID.
    7. Pressthe key.
    8. Select3$1(/7<3(usingthe  keys.
    9. Usethe  keystoselectthedesiredpanel.
    10. Select86(5,'usingthe  keys.
    11. Todisplayallresultsfortheselectedpanel,pressthe key.
    12. TodisplayresultsspecifictooneUserID,typeintheUserID.Tocorrect,press tocleartheentireID,

    orselecttheincorrectcharacterbyusingthe  keys.ThentypeinthecorrectID.

    NOTE:IftheUserIDbypassisON,themeterwillnotaskyoutoenteraUserID
    
    13. Pressthe key.
    14. Allresultsfromtestsrunbytherequesteduserfortheselectedpanelaredisplayed.
    15. Usethe  keystoviewtheentirerecord.
    16. Pressthe keytomakeaprintedcopy.
    17. Pressthe keytouploadtheselectedresultstoLIS.
    
    FromDate „ MainMenu
    ToretrieveresultsfromtestsrunontheQuidelTriageMeterProstartingwith „ RecallResults
    adateyouselect: „ PatientResults
    
    1. Pressthe keytopowertheQuidelTriageMeterProon.
    2. FromtheMAINMENUselectRECALLRESULTSusingthe  keys.
    3. Pressthe key.

    Page52of86
    4. SelectPATIENTRESULTSusingthe  keys.
    5. Pressthe key.
    6. Typeorscaninyouridentification(UserID).Tocorrect,press tocleartheentireID,orselectthe
    incorrectcharacterbyusingthe  keys.ThentypeinthecorrectID.

    NOTE:IftheUserIDbypassisON,themeterwillnotaskyoutoenteraUserID.
    
    7. Pressthe key.
    8. SelectPANELTYPEusingthe  keys.
    9. Usethe  keystoselectthedesiredpanel.
    10. SelectFROMDATEusingthe  keys.
    11. Todisplayallresultsfortheselectedpanel,pressthe key.
    12. Todisplayresultsspecifictoonedate,typeinthedate.Tocorrect,pressthe keytocleartheentire
    number.Thentypeinthecorrectnumber.
    13. Pressthe key.
    14. Allresultsfromtestsrunfromthedateselectedfortheselectedpanelaredisplayed.
    15. Usethe  keystoviewtheentirerecord.
    16. Pressthe keytomakeaprintedcopy.
    17. Pressthe keytouploadtheselectedresultstoLIS.
    
    TillDate
    „ MainMenu
    ToretrieveresultsfromtestsrunontheQuidelTriageMeterProbeforeandincluding
    „ RecallResults
    adateyouselect:
    „ PatientResults
    
    1. Pressthe keytopowertheQuidelTriageMeterProon.
    2. FromtheMAINMENUselectRECALLRESULTSusingthe  keys.
    3. Pressthe key.
    4. SelectPATIENTRESULTSusingthe  keys.
    5. Pressthe key.
    6. Typeorscaninyouridentification(UserID).Tocorrect,press tocleartheentireID,orselectthe
    incorrectcharacterbyusingthe  keys.ThentypeinthecorrectID.

    NOTE:IftheUserIDbypassisON,themeterwillnotaskyoutoenteraUserID
    
    7. Pressthe key.

    Page53of86
    8. Select3$1(/7<3(usingthe  keys.
    9. Usethe  keystoselectthedesiredpanel.
    10. Select7,//'$7(usingthe  keys.
    11. Todisplayallresultsfortheselectedpanel,pressthe key.
    12. Todisplayresultsspecifictoonedate,typeinthedate.Tocorrect,pressthe keytocleartheentire
    number.Thentypeinthecorrectnumber.
    13. Pressthe key.
    14. Allresultsfromtestsrunbeforeandincludingthedateyouselectedfortheselectedpanelare
    displayed.
    15. Usethe  keystoviewtheentirerecord.
    16. Pressthe keytomakeaprintedcopy.
    17. Pressthe keytouploadtheselectedresultstoLIS.
    
    
    QCResults
    Options:Theresultsofthesequalitycontrol(QC)testscanberetrievedfromthe „ MainMenu
    QuidelTriageMeterPro’smemory: „ RecallResults
    
     QualityControl(QCtest) Resultscanberetrievedby:

     QCSampleResults PanelType
    QCSampleLotNumber(L/N)
    
    DeviceLotNumber(L/N)
    
    UserID
     FromDate
     TillDate
     ViewAll(Default)
     QCDeviceResults UserID
    FromDate
    
    TillDate
    
    ViewAll(Default)
    
     ReagentLots–QC (DefaultstoViewAll)
    
    ToretrieveQCResultsfortheQCSampleandtheQCDevice,selecttheoptiondesiredandfollowthe
    directions.
    
    
    NOTE:Youmaychoosemorethanoneoftheoptionsforrecallingresultsinordertomoreprecisely
     definetheinformationyouwanttorecallfromtheQuidelTriageMeterPro’smemory.Whenyouchoose
     multipleoptions,firstmakeselectionsandinputvaluesinallthecategoriesyouhavechosen.Thenpress
    theENTERkey.

    Page54of86
    
    QCSampleLotNumber(L/N) „ MainMenu
    ToretrieveresultsbasedonthelotnumberoftheQCSampleused: „ RecallResults
    1. Pressthe keytopowertheQuidelTriageMeterProon. „ QCResults
    „ QCSampleResults
    2. FromtheMAINMENUselectRECALLRESULTSusingthe  keys.
    3. Pressthe key.
    4. SelectQCRESULTSusingthe  keys.
    5. Pressthe key.
    6. SelectQCSAMPLERESULTSusingthe  keys.
    7. Pressthe key.
    8. SelectPANELTYPEusingthe  keys.
    9. Usethe  keystoselectthedesiredpanel.

    10. SelectQCSAMPLEL/Nusingthe  keys.


    11. TypeintheQCSamplelotnumberofthetestdevice.Tocorrect,press tocleartheentirenumber.
    Thentypeinthecorrectnumber.

    NOTE:Todisplayallresultsfortheselectedpanel,leavetheQCSampleL/Nblank.

    12. Pressthe key.


    13. AllresultsfromtestrunontherequestedQCSamplelotnumberfortheselectedpanelaredisplayed.
    14. Usethe  keystoviewtheentirerecord.
    15. Pressthe keytomakeaprintedcopy.
    16. Pressthe keytouploadtheselectedresultstoLIS.
    

    
    DeviceLotNumber(L/N) „ MainMenu
    ToretrieveQCSampleresultsbasedonthelotnumberofthetestdevicesused: „ RecallResults
     „ QCResults
     „ QCSampleResults
    

    
    
    
    
    
    
    
    1. Pressthe keytopowertheQuidelTriageMeterProon.
    2. FromtheMAINMENUSELECTRECALLRESULTSusingthe keys.
     

    Page55of86
    3. Pressthe key.
    4. SelectQCRESULTSusingthe  keys.
    5. Pressthe key.
    6. SelectQCSAMPLERESULTSusingthe  keys.
    7. Pressthe key.
    8. SelectPANELTYPEusingthe  keys.
    9. Usethe  keystoselectthedesiredpanel.
    10. SelectDEVICEL/Nusingthe  keys.
    11. Typeinthedevicelotnumberfromthesideoftheboxoftestdevices.Tocorrect,pressthe keyto
    cleartheentirenumber.Thentypeinthecorrectnumber.
    12. Pressthe key.
    13. AllQCresultsthathavebeenrunontherequestedlotnumberfortheselectedpanelaredisplayed.
    14. Usethe  keystoviewtheentirerecord.
    15. Pressthe keytomakeaprintedcopy.
    16. Pressthe keytouploadtheselectedresultstoLIS.
    
    „ MainMenu
    UserID „ RecallResults
    ToretrieveQCresultsfromtestsrunontheQuidelTriageMeterProstarting „ QCResults
    withtheuseryouselect: „ QCSampleResults
    1. Pressthe keytopowertheQuidelTriageMeterProon. „ QCDeviceResults
     FromtheMAINMENUselectRECALLRESULTSusingthe 
    keys.

    3. Pressthe key.


    4. SelectQCRESULTSusingthe  keys.
    5. Pressthe key.
    6. Selecttheappropriatemenu,QCSAMPLERESULTSorQCDEVICERESULTSusingthe  keys.
    7. Pressthe key.
    8. IfQCSAMPLERESULTS,selectPANELTYPEusingthe  keys.
    9. Usethe  keystoselectthedesiredpanel.
    10.SelectUSERIDusingthe  keys.
    11.Pressthe key.
    12.TypeintheuserID.Tocorrect,pressthe keytocleartheentireID,orselecttheincorrectcharacter
    byusingthe  keys.ThentypeinthecorrectID.
    13.Pressthe key.
    14.AllQCSampleorQCDeviceresultsfromtestsrunbytherequesteduser,fortheselectedpanelifQC
    Sample,aredisplayed.

    Page56of86
    15.Usethe  keystoviewtheentirerecord.
    16.Pressthe keytomakeaprintedcopy.
    17.Pressthe keytouploadtheselectedresultstoLIS.
    
    FromDate „ MainMenu
    ToretrieveQCresultsfromtestsrunontheQuidelTriageMeterProstarting „ RecallResults
    withadateyouselect: „ QCResults
    1. Pressthe keytopowertheQuidelTriageMeterProon. „ QCSampleResults
    „ QCDeviceResults
    2. FromtheMAINMENUselectRECALLRESULTSusingthe  keys.
    3. Pressthe key.
    4. SelectQCRESULTSusingthe  keys.
    5. Pressthe key.
    6. Selecttheappropriatemenu,QCSAMPLERESULTSorQCDEVICERESULTSusingthe  keys.
    7. Pressthe key.
    8. IfQCSAMPLERESULTS,selectPANELTYPEusingthe  keys.Usethe  keystoselectthe
    desiredpanel.
    9. SelectFROMDATEusingthe  keys.
    10. Pressthe key.
    11. Typeinthedate.Tocorrect,pressthe keytocleartheentirenumber.Thentypeinthecorrect
    number.
    12. Pressthe key.
    13. Allresultsfromtestsrunfromthedateselected,fortheselectedpanelifQCSample,aredisplayed.
    14. Usethe  keystoviewtheentirerecord.
    15. Pressthe keytomakeaprintedcopy.
    16. Pressthe keytouploadtheselectedresultstoLIS.
    
    TillDate
    ToretrieveQCresultsfromtestsrunontheQuidelTriageMeterProbeforeand
    includingadateyouselect: „ MainMenu
    „ RecallResults
    1. Pressthe keytopowertheQuidelTriageMeterProon. „ QCResults
    2. FromtheMAINMENUselectRECALLRESULTSusingthe keys. „ QCSampleResults
    
    „ QCDeviceResults
    3. Pressthe key.
    4. SelectQCRESULTSusingthe  keys.
    5. Pressthe key.
    6. Selecttheappropriatemenu,QCSAMPLERESULTSorQCDEVICERESULTSusingthe  keys.
    7. Pressthe key.
    8. IfQCSAMPLERESULTS,selectPANELTYPEusingthe  keys.Usethe  keystoselectthe
    desiredpanel.

    Page57of86
    9. SelectTILLDATEusingthe  keys.
    10. Pressthe key.
    11. Typeinthedate.Tocorrect,pressthe keytocleartheentirenumber.Thentypeinthecorrect
    number.
    12. Pressthe key.
    13. Allresultsfromtestsrunbeforeandincludingthedateselected,fortheselectedpanelifQCSample,are
    displayed.
    14. Usethe  keystoviewtheentirerecord.
    15. Pressthe keytomakeaprintedcopy.
    16. Pressthe keytouploadtheselectedresultstoLIS.
    
    ReagentLots–QC „ MainMenu
    AlistofReagentCODECHIPmodulesinmemory,alongwithcorresponding „ RecallResults
    expirationdatesforaQCSamplecanberecalledfrommemory. „ QCResults
    „ ReagentLots–QC
     „ ArchiveLastTest
    Thelistwillcontain:LotNumber,PanelType,ExpirationDate
    
    „
    „ IftheQCexpirationdatehaspassed(expired),thedatewillbeinreversevideo(lighttextonadark
    
    „ background).
    „ IftheQCforthelothasfailed,thewordFAILEDwillappearinplaceofanexpirationdate.
    „ IfaCODECHIPhasbeeninstalledforanewlot,butQChasyettobeestablished,thewordsNOTRUN
    „ willappearinplaceoftheexpirationdate.
    „ IfQCfrequencyissettonone,thereagentlotexpirationdatewillbedisplayed.
    „
     
    „  REAGENTLOTSͲQC 
    „   
    „ DLN PANEL EXP
    „ 
    „ 
    47067 CARDIAC 12Ͳ16Ͳ17
    „  48741 CARDIAC 09Ͳ04Ͳ18
    „  48197 BNP NOTRUN
    „ 
    „  47827 DRUGSCREEN FAILED
      
    PRESSPRINTORPRESSENTER
    TheReagentLots–QCScreen
    
    ArchiveLastTest
    ThisfunctionwillsavedetailedinformationregardingthelastperformedtestforanalysisbyQuidel.Usethis
    functionwhenrequestedbyQuidel.
    
    Thisfunctionshouldbeusedwhenaveryunusualtestresultisreceivedandwhenthelaboratorywishesto
    havethemeterevaluatedfurther.ARCHIVELASTTESTwillonlybeabletosavedatafromthemostrecent
    testrun.
    
    
    
    
     Page58of86

    
    Misc.TestResults „ MainMenu
    Options: Misc.Testresultscanberetrievedbasedonavarietyofcriteria: „ RecallResults
    „ Misc.TestID
    „ TestDeviceLotNumber(L/N)
    „ UserID
    „ FromDate
    „ TillDate
    
    Misc.TestID „ MainMenu
    ToretrieveresultsbasedontheMisc.TestID: „ RecallResults
    „ MiscTestResults
    1. Pressthe keytopowertheQuidelTriageMeterProon.

    2. FromtheMAINMENUselectRECALLRESULTSusingthe  keys.

    3. Pressthe key.

    4. SelectMISC.TESTRESULTSusingthe  keys.

    5. Pressthe key.

    6. SelectPANELTYPEusingthe  keys.

    7. Usethe  keystoselectthedesiredpanel.


    8. Choosetheresultsyouwanttosee:

    NOTE:Youmaychoosemorethanoneoftheoptionsforrecallingresultsinordertodefinemoreprecisely
    theinformationyouwanttorecallfromtheQuidelTriageMeterPro’smemory.Whenyouchoosemultiple
    options,firstinputvaluesinallthecategoriesyouhavechosen.ThenpresstheENTERkey.

    „ IfyouwanttoseeallMisc.Testresults,pressthe key.AlltheMisc.TestresultsintheQuidelTriage
    MeterPro’smemoryfortheselectedpanelwillbedisplayed.
    „ ForindividualMisc.Testresults:
    a. SelectMISC.TESTIDusingthe  keys.

    b. TypeorscanintheMisc.TestID.Tocorrect,pressthe keytocleartheentireID,orselectthe


    incorrectcharacterbyusingthe  keys.ThentypeinthecorrectID.

    c. ToselectaMisc.TestIDwithalphacharacters,usethe keytoenteralphacharactersorusethe


    keyinplaceofthealphacharacter.

    d. Pressthe key.AllresultsoftherequestedMisc.TestIDfortheselectedpanelwillbedisplayed.

    9. Usethe  keystoviewtheentirerecord.

    10. Pressthe keytomakeaprintedcopy.

    11. Pressthe keytouploadtheselectedresultstoLIS.


    

    Page59of86
    TestDeviceLotNumber(L/N) „ MainMenu
    Toretrieveresultsbasedonthelotnumberofthetestdevicesused: „ RecallResults
     Pressthe keytopowertheQuidelTriageMeterProon. „ MiscTestResults
    

    
    

    2. FromtheMAINMENUselectRECALLRESULTSusingthe  keys.


    3. Pressthe key.

    4. SelectMISC.TESTRESULTSusingthe  keys.

    5. Pressthe key.

    6. SelectPANELTYPEusingthe  keys.

    7. Usethe  keystoselectthedesiredpanel.

    8. SelectDEVICEL/Nusingthe  keys.

    9. Todisplayallresultsfortheselectedpanel,pressthe key.

    10. Todisplayresultsspecifictoonelot,typeinthelotnumberofthetestdevice.Tocorrect,pressthe 
    keytocleartheentirenumber.Thentypeinthecorrectnumber.

    NOTE:OnlyenterthefiveͲdigitnumericvalueoftheQClotnumber.

    11. Pressthe key.


    12. Allresultsfromtestsrunontherequestedlotnumberfortheselectedpanelaredisplayed.

    13. Usethe  keystoviewtheentirerecord.

    14. Pressthe keytomakeaprintedcopy.

    15. Pressthe keytouploadtheselectedresultstoLIS.

    
    
    
    

    Page60of86
    UserID
    ToretrieveresultsfromtestrunontheQuidelTriageMeterProstartingwith „ MainMenu
    theuseryouselect: „ RecallResults
    „ MiscTestResults
    1. Pressthe keytopowertheQuidelTriageMeterProon.

    2. FromtheMAINMENUselectRECALLRESULTSusingthe  keys.

    3. Pressthe key.

    4. SelectMISC.TESTRESULTSusingthe  keys.

    5. Pressthe key.

    6. SelectPANELTYPEusingthe  keys.

    7. Usethe  keystoselectthedesiredpanel.

    8. SelectUSERIDusingthe  keys.

    9. Todisplayallresultsfortheselectedpanel,pressthe key.

    10. TodisplayresultsspecifictooneUserID,typeintheUserID.Tocorrect,press tocleartheentireID,


    orselecttheincorrectcharacterbyusingthe  keys.ThentypeinthecorrectID.

    11. Pressthe key.


    12. Allresultsfromtestsrunbytherequesteduserfortheselectedpanelaredisplayed.
    13. Usethe  keystoviewtheentirerecord.

    14. Pressthe keytomakeaprintedcopy.

    15. Pressthe keytouploadtheselectedresultstoLIS.

    FromDate „ MainMenu
    ToretrieveresultsfromtestrunontheQuidelTriageMeterProstartingwithadate „ RecallResults
    youselect: „ MiscTestResults
     Pressthe keytopowertheQuidelTriageMeterProon.

    2. FromtheMAINMENUselectRECALLRESULTSusingthe  keys.

    3. Pressthe key.

    4. SelectMISC.TESTRESULTSusingthe  keys.

    5. Pressthe key.

    6. SelectPANELTYPEusingthe  keys.

    7. Usethe  keystoselectthedesiredpanel.

    8. SelectFROMDATEusingthe  keys.

    Page61of86
    9. Todisplayallresultsfortheselectedpanel,pressthe key.

    10. Todisplayresultsspecifictoonedate,typeinthedate.Tocorrect,pressthe keytocleartheentire


    number.Thentypeinthecorrectnumber.
    11. Pressthe key.
    12. Allresultsfromtestsrunfromthedateselectedfortheselectedpanelaredisplayed.
    13. Usethe  keystoviewtheentirerecord.

    14. Pressthe keytomakeaprintedcopy.

    15. Pressthe keytouploadtheselectedresultstoLIS.


    

    TillDate „ MainMenu
    ToretrieveresultsfromtestrunontheQuidelTriageMeterProbefoeandincluding „ RecallResults
    adateyouselect: „ MiscTestResults

    1. Pressthe keytopowertheQuidelTriageMeterProon.

    2. FromtheMAINMENUselectRECALLRESULTSusingthe  keys.


    3. Pressthe key

    4. SelectMISC.TESTRESULTSusingthe  keys.

    5. Pressthe key.

    6. SelectPANELTYPEusingthe  keys.

    7. Usethe  keystoselectthedesiredpanel.

    8. SelectTILLDATEusingthe  keys.

    9. Todisplayallresultsfortheselectedpanel,pressthe key.

    10. Todisplayresultsspecifictoonedate,typeinthedate.Tocorrect,pressthe keytocleartheentire


    number.Thentypeinthecorrectnumber.
    11. Pressthe key.
    12. Allresultsfromtestsrunbeforeandincludingthedateyouselectedfortheselectedpanelare
    displayed.
    13. Usethe  keystoviewtheentirerecord.

    14. Pressthe keytomakeaprintedcopy.

    15. Pressthe keytouploadtheselectedresultstoLIS.


    
     

    Page62of86
    PrintAllResults „ MainMenu
    Options:AllstoredresultscanbeprintedfromtheQuidelTriageMeterPro’s „ RecallResults
    memory. „ MiscTestResults
    „ PatientResults
    „ QCSampleResults
    „ QCDeviceResults
    „ Misc.TestResults
    

    PatientResults „ MainMenu
    ToprintallPatientResults: „ RecallResults
    „ PrintAllResults
    1. Pressthe keytopowertheQuidelTriageMeterProon.

    2. FromtheMAINMENUselectRECALLRESULTSusingthe  keys.

    3. Pressthe key.


    4. SelectPRINTALLRESULTSusingthe  keys.

    5. Pressthe key.

    6. SelectPATIENTRESULTSusingthe  keys.


    7. Pressthe key.

    8. Typeorscaninyouridentification(UserID).Tocorrect,press tocleartheentireID,orselectthe


    incorrectcharacterbyusingthe  keys.ThentypeinthecorrectID.

    9. Pressthe keytomakeaprintedcopy.

    NOTE:Whenprintinglargequantitiesofpatientresults,itisrecommendedtofirstinsertafullrollof
    paper.

    NOTE:IftheUserIDbypassisON,themeterwillnotaskyoutoenteraUserID.
    
    QCSampleResults
    ToprintallQCSampleResults:
    1. Pressthe keytopowertheQuidelTriageMeterProon.
    2. FromtheMAINMENUselectRECALLRESULTSusingthe  keys.
    3. Pressthe key.
    4. SelectPRINTALLRESULTSusingthe  keys.
    5. Pressthe key.
    6. SelectQCSAMPLERESULTSusingthe  keys.
    7. Pressthe keytomakeaprintedcopy.

    Page63of86
    
    QCDeviceResults „ MainMenu
    ToprintallQCDeviceResults: „ RecallResults
    „ PrintAllResults
    1. Pressthe keytopowertheQuidelTriageMeterProon.
    2. FromtheMAINMENUselectRECALLRESULTSusingthe  keys.
    3. Pressthe key.
    4. SelectPRINTALLRESULTSusingthe  keys.
    5. Pressthe key.
    6. SelectQCDEVICERESULTSusingthe  keys.
    7. Pressthe keytomakeaprintedcopy.
    
    Misc.TestResults
    ToprintallMisc.TestResults:
    1. Pressthe keytopowertheQuidelTriageMeterProon.

    2. FromtheMAINMENUselectRECALLRESULTSusingthe  keys.

    3. Pressthe key.

    4. SelectPRINTALLRESULTSusingthe  keys.

    5. Pressthe key.

    6. SelectMISC.TESTRESULTSusingthe  keys.

    7. Pressthe keytomakeaprintedcopy.


    

    UploadResultstoLIS „ MainMenu
    WheninterfaceddirectlytoanLIS,selectingthisfeaturewillsendalltestresults „ RecallResults
    totheLIS.Priortothefirstupload,theLISfeaturemustbeactivatedfromthe „ UploadResultstoLIS
    SetParametermenuitemusingtheSupervisorCODECHIPmodule.
    
    
    DeleteResults
    Purpose
    TheDeletefunctionisusedtoremoveallpatienttestinformationfromtheQuidelTriageMeterPromemory.

    NOTE:ThedeletefunctionisavailableonlywhentheSupervisorCODECHIPmoduleisinsertedinthe
    QuidelTriageMeterProCODECHIPmodulePort.

    Page64of86
    THEQuidelTriageMeterProMemory
    WithintheQuidelTriageMeterPro,PatientResultmemorycanhold750datasets,QCSamplecanhold200
    datasets,QCDevicecanhold70datasets,andMisc.Testcanhold250datasets.Whenthememoryisfull,
    theoldestresultisautomaticallyoverwrittenwhenanewresultisadded.Themeterdisplayalertstheuser
    asthepatientmemorybecomesfull.
    
    

    WARNING
    
    PATIENTMEMORYHAS
    SPACEFORXXXMORE
    RECORDS
    
    PRESSENTER
    TheMemoryAlertScreen
    

     IMPORTANT:TheDeletefunctionpermanentlyremovesallpatientdatafromthemetermemory.
    Beforecontinuing,youmaywishtofirstprintresults(oruploadtoyourdatamanagement
    system/LIS).QCorMisc.TestResultscannotbemanuallydeleted.
    
    DeletePatientResult „ MainMenu
    Thisfunctionwilldeleteallpatientresultsinmetermemory.Sincethisactionisnot „ DeleteResults
    reversible,themeterwillrequiretwoconfirmationsofintenttodeleteresults.
    
    1. InserttheSupervisorCODECHIPmoduleintheCODECHIPmodulePort
    

    
    2. FromtheMAINMENU,selectDELETERESULTSusingthe  keys.
    
     

    Page65of86
    
    8:23AM01•20•18

    RUNTEST
    RECALLRESULTS
    INSTALLNEWCODECHIP
    SETPARAMETERS
    DELETERESULTS
    
    SELECTWITHvOR^ANDPRESSENTER
    PRESSEXITTOEJECTDEVICE
    TheSupervisor’sMainMenu
    

    NOTE:PresstheEXITkeytocancelatanytimebeforestep7.
    

    3. Pressthe key.


    4. Awarningmessageonthescreenstates:DELETEPATIENTRESULT.
    5. Ifthisisacceptable,pressthe key.(Ifthisisnotacceptable,pressthe key).
    6. Amessageonthescreenstates:ALLPATIENTRESULTSWILLBEDELETED.
    7. Pressthe keytodeleteallpatientresults.(Ifyoudonotwanttodeleteallpatientresults,pressthe key).
    
    
    DisplayBacklight
    TheQuidelTriageMeterProhasthecapabilityfortheoperatortobacklightthedisplayforproviding
    improvedclaritydependingonambientlightingconditions.Thebacklightfeaturecanbecontrolledbythe
    backlightbutton onthekeypad.Whenthebacklightbutton ispressed,thebacklightinitially
    comesonatmaximumbrightness.Subsequentpressescyclethebacklightfrombrighttodimandthento
    off.Tosavepower,thebacklightturnsoffifnokeyshavebeenpressedfor15seconds.Pressinganykeywill
    restorethebacklighttothepreviouslevel.
     

    Page66of86
    
    AlphaNumericMode
    TheQuidelTriageMeterProhasthecapabilityfortheoperatortoenterbothnumericandalphacharacters
    
    fromthekeypad.Thekeypadoperatesinnumericmodeuntilalphamodeisactivatedbypressingthe 
    
    key.Themeterstaysinalphamode,indicatedbytheletters"ABC"shownatthetopofthedisplay,untilthe
     keyispressedagain.Wheninalphamode,pressinganykeycausesthealphacharactertobe
    
    displayed.

     1 Ͳ/#()*.\ 7 PQRS
    2 ABC 8 TUV
     3 DEF 9 WXYZ
     4 GHI 0 noalphacharacterisdisplayed
    5 JKL . noalphacharacterisdisplayed
     6 MNO  
    
    Thefirstpressofabuttoncausesthefirstlettertobedisplayed.Thesecondpressofthesamebuttonwithin
    threesecondscausesthesecondlettertobedisplayed.Thethirdpressofthesamebuttonwithinthree
    
    secondscausesthethirdlettertobedisplayed.
    
    Afterthelastcharacterinasequenceisdisplayed,thenextbuttonpressofthesamebuttonwithin3
    secondsdisplaysthefirstcharacterandthesequenceisrepeated.
    
    Ifmorethanthreesecondspasswithouttheoperatorpressingthebutton,thenextpressofthatbutton
    causesthefirstcharactertobedisplayed.Ifanewbuttonispressed,thefirstcharacterofthenewbuttonis
    displayedwithsubsequentpressesrepeatingthesequence.
    
    
    
    
    
     
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
     Page67of86
    
    
    ServiceandMaintenanceProcedures
    Ifanyserviceormaintenanceisrequired,theQuidelTriageMeterProshouldbesenttothemanufacturer.
    Nomaintenanceotherthanpaper/batteryreplacementandperiodicexternalcleaningisrequiredofthe
    operator.
    
    PaperReplacement
    ChangingPaperBetweenFunctions
    1. TearoffanyexcesspaperstickingoutoftheQuidelTriageMeterPro.
    2. Removethepapercompartmentcoverbypullinguponthecoverasindicatebythearrowontheback
    ofthecover.

    
    3. Removeunusedpaperortheemptypaperspindlefrompapercompartment.
    4. Tearorcutaclean,straightedgetofeedintotheprinter.Donotcutpaperatanangle,astheprinter
    mustsensetheedgeofthepaperalongthefeedpath.

    NOTE:Theprintercontainsapapersensorandwillfeedthenewpaperrollonlywhenpaperwithaclean
    straightlineispressedintothepaperroller.

    
    
    5. Insertthenewrollofpaperintothepapercompartment.
    6. Positionthepapersuchthatthepaperwillfeedfromundertheroll(asopposedtooverthetopofthe
    roll,seepicture,above).
    7. Insertthepaperedgeunderthepaperroller(platen)untilitfirmlyseatsorresistanceisfelt.
    8. Pressthe key.

    NOTE:IfPAPERFEEDbuttonispressedbeforetheprintersensesthepaper,theprinterwillnotrespond
    tothecommand.
    
    9. Replacethecoveroftheprinterandcontinueoperation.

    NOTE:Theprinterutilizesthermalpaper,iftheprintedpaperisblankafterreplacingaroll,verifythatthe
    paperrollisnotupsidedown.
    Page68of86
    ChangingPaperWhilePrinting
    IfthemeterrunsoutofpaperwhileinthemiddleofaprintingtaskandisdisplayingthemessagePRINTER
    FAILURE,CHECKPRINTERORREPLACEPAPER,thepapermaybechangedandtheprintjobcontinued
    withoutlossofdataorreprintingfromthebeginning.Performthefollowingstepspriortopressinganynew
    keys:
    1. Removethepapercompartmentcoverbypullinguponthecoverasindicatebythearrowontheback
    ofthecover.
    

    
    
    2. Gentlypullremainingpaperslowlyupthroughtheprinter.
    3. Removepaperspindlefromthepapercompartment.
    4. Tearorcutaclean,straightedgetofeedintotheprinter.Donotcutpaperatanangle,astheprinter
    mustsensetheedgeofthepaperalongthefeedpath.

    NOTE:Theprintercontainsapapersensorandwillfeedthenewpaperrollonlywhenpaperwithaclean
    straightlineispressedintothepaperroller.

    
    
    5. Insertthenewrollofpaperintothepapercompartment.
    6. Positionthepapersuchthatthepaperwillfeedfromundertheroll(asopposedtooverthetopofthe
    roll,seepicture,above).
    7. Insertthepaperedgeunderthepaperroller(platen)untilitfirmlyseatsoraresistanceisfelt.
    8. Pressthe key.
    

    NOTE:IfPAPERFEEDbuttonispressedbeforetheprintersensesthepaper,theprinterwillnotrespond
    tothecommand.

    
    9. Whentheprinterbeginstopullthepaperin,releasethepaper.TheprinterwillfeedafewlinesandreͲ
    commencetheprintjob.Toensurenodataislost,theprinterwillreprintuptotheprevious5lines.
    10.Afterthepaperhasappearedabovetheprinter,replacetheprintercover,takingcaretoensurethe
    paperdoesnotgetcaughtinsidethemeter.

    NOTE:Theprinterutilizesthermalpaper,iftheprintedpaperisblankafterreplacingaroll,verifythatthe
    paperrollisnotupsidedown.
    Page69of86
    
    Cleaning
    TheQuidelTriageMeterProrequiresminimalmaintenance.Occasionalcleaningoftheexteriorwithmild
    soapandwatersolutionissufficient.Afterusingadamp,notwet,spongeorclothtoapplyamildsoapand
    watersolutionontheoutsideofthemeter,wipethemeterdryusingasoftclothorabsorbenttissue.Donot
    allowwatertoseepintotheprinter.Donotimmersethemeterinwaterorotherliquids.
    
    Ifbloodorotherfluidsarenotallowedenoughtimetofullyabsorbintotestdevices,thedevicetrackdoor
    mayoccasionallyrequirecleaning.Usingacottonswabdampenedwithisopropylalcoholandapairof
    tweezers,carefullyliftthedoorandcleanbothfrontandbackofthedoor.
    

    NOTE:Neverinsertanytools,swabs,orcleaningmaterialsintothedevicetrack.
    
    
    CheckBatteryLevel
    TheQuidelTriageMeterProcheckstheactivepowersourceafterejectingadeviceorprinting.Tocheckthe
    batterypower,navigatetotheMAINMENU,disconnecttheACpowersupply,pressthe key(themeter
    attemptstoejectthedevice),andlookfortheLowPowerIndicatorontheMainMenuofthemeterdisplay.
    Iftheflashingindicatorappears,replacethebatteries.

    NOTE:Themeterisdesignedtoperformandprintatleast100testsbeforenewbatteriesarerequiredtobe
    replaced.Whenthemeterisnotinuse,itshouldbeturnedoff.Topreservebatterylife,ensuretheAUTO
    POWERͲOFFfunctionissetto1/2HOUR.

    
    BatteryReplacement
    „ Turnoffthemeter.
    „ Removethebatterycoverfromthebottomofthemeterbyslidingthecoverinthedirectionofthe
    arrow.

    Page70of86
    „ Removethebatteries.Somecountriesrequirethatbatteriesbedisposedofinaccordancewithspecific
    governmentalregulations(Directive2006/66/EC).Disposeofthebatteriesincompliancewithlocal
    regulations.
    „ InsertfoursizeAA1.5Ͳvoltbatteriesintothebatterycompartment.Besurethattheplus(+)andminus
    (Ͳ)signsofthebatteriesmatchthesamesignsembossedinthebatterycompartment
    „ Replacethecovertothebatterycompartment.

    NOTE:Ifthemeterdoesnotpoweronafterreplacingbatteries,verifythebatteriesarelinedupaccording
    tothesymbolsinthebatterycompartment.

    
    

    NOTE:Rechargeablebatteriesareauthorizedforuse,howeverduetothenatureofthesetypesof
    batteries,itisexpectedtheywillrequirerechargingmorefrequently.TheQuidelTriageMeterProdoesnot
    containabuiltͲinbatterycharger,rechargeablebatteriesmustberechargedoutsideofthemeter.

    
    
    TotalQualityAssurance
    Introduction

    NOTE:Formoredetailedinformation,contactQuidel.
    
    Qualityassuranceprogramscontrolandmonitoranalyticalmethods.Thequalitycontrolofanalytical
    methodsachievestwobasicgoals:
    1. Ensuresthatthereagentsandinstrumentareworkingproperly
    2. Ensuresthattheprocedurewasperformedcorrectly

    Themechanismbywhichanalyticalmethodsaretraditionallycontrolledisthroughtheuseofliquidcontrol
    specimenscontainingknownamountsofanalytes.
    
    Overthelast15yearsadvancesintechnologyhavechangedthemannerinwhichthediagnosticreagents
    areconfigured.AssaysystemsforthePointͲofͲCarearegenerallyunitizedtestingdevicesthataredistinct
    fromtraditionallaboratoryͲbasedanalyzers.TheQuidelTriagetestsareunitizedteststhatdonotrequire

    Page71of86
    additionalreagents.Eachdevicecontainsafullcomplementofreagentsthatarerequiredtoperformthe
    immunoassay.
    
    TheQuidelTriagetestshavebeendesignedtoincludeassaycontrolsineachtestdevicethatmonitorthe
    assayprocedureandthereagentintegrity.Theassaycontrolspresentauniqueandvaluableextensionto
    thetraditionalapproachtoqualitycontrolusingliquidreagents.Iftheproductisstoredunderspecified
    conditions,properfunctioningoftheassaycontrolsindicatesthatthetestdeviceisvalidandproper
    adherencetoassayprotocolhasbeenfollowed.TheassaycontrolsintheQuidelTriagetestsrequirethe
    needtoreͲthinkthefrequencywithwhichexternalqualitycontrolspecimensshouldbetested.
    
    TheQuidelTriagetestshavebeendesignedtoyieldlongͲtermreagentstability.Inaddition,thesystem
    providesqualitycontrolparametersinthreeseparateanddistinctcategories:
    „ Internaldevicecontrols
    „ Meterelectroniccontrols
    „ Softwarecontrols.

    Thecombinationofthesequalitycontrolfeaturesprovidesmoreinformationaboutthevalidityofeach
    assaythancanbeprovidedbythemoretraditionalmethodsofreagentandassayprocedurevalidation.
    
    QualityAssuranceFunctions
    1. InternalDeviceQualityAssurance
    „ InternalPositiveControlZone
    „ BaselineControlZone
    „ TimingControlZone
    „ ZoneQualityRequirements(TraceQC)
    2. MeterQualityAssurance
    „ SelfͲTestMode
    „ InternalCalibrationChip
    „ ElectronicQCDevice
    „ BarCode
    3. SoftwareQualityAssurance
    „ SupervisorCODECHIPmodule
    „ UserID#
    „ PatientID#
    „ Resultmemorystorage
    „ QCFrequency
    „ QCLockouts
    4. QualityControlSamples
    
    InternalDeviceQualityAssurance
    TheInternalControlZonesarebuiltͲinfunctionalimmunoassays.Thiscontrolverifiesthatthedevice
    functionedproperlyandthattheassaywascorrectlyperformed.TheInternalPositiveControlZoneensures
    thattheantibodies,thereagentreconstitution,thetimegateandthedeviceflowarefunctioningproperly.
    Themanufacturersetsacceptablerangesforthecontrolzonesforeachlotofreagents.
    
    TheBaselineControlZonemonitorsthepresenceofinterferingsubstancesinthepatientsamplethatmay
    altertheimmunoassayprocess.Ifaspecimencontainsasubstancethathasamajoreffectonthehighand

    Page72of86
    lowcontrolsandthebaselinecontrolandtherebyontheimmunoassay,theresultsarenotdisplayedand
    erroneousresultsarenotreported.
    
    TheTimingControlZonemonitorsassaycompletion.Ifaninadequateamountofspecimenisaddedtothe
    testdeviceorifaspecimenclotsinthedevice,thiscontrolwillpreventthedisplayoftheresults.
    
    ATraceQCalgorithmhasbeenprogrammedwhichevaluatesthesize,locationandsignaltonoiseratioof
    eachzoneonthedevice.Aberrationsinzonequalityexceedingpresetlimitswillcauserejectionofoneor
    moreoftheassayresults.
    
    MeterQualityAssurance
    TheSelfͲTestModeisinitiatedeachtimethemeteristurnedON.IntheselfͲtestmodethemeterscansan
    InternalCalibrationChip.Eachcalibrationchipscanisusedtovalidateandadjust,ifnecessary,themeter
    calibration.IntheselfͲtestmode,theavailablememoryforpatientresultsischecked.Whenthecapacityis
    belowapreͲsetlimit,theremainingcapacityisrelatedviaascreenmessage.Thesoftwareprogramis
    evaluatedandisterminatedifcorrupted.SoftwaretestresultsandCODECHIPmoduledataareverifiedfor
    integritybeforeeachuse.
    
    AQCDeviceisprovidedwitheachmetertoallowtheusertofurtherchecktheintegrityofthemeter.The
    simulatorcontainssixfluorescentzonesofvaryingintensitythataremeasuredbythemeter.TherearepreͲ
    programmedacceptablerangesforthesixzones.Inaddition,thezonesallowthemetertocheckfor
    horizontalandverticalalignmentofthezonemeasurementtoverifylaseralignmentanddevicetransport.
    TheQCDevicealsoconfirmslaserstability.
    
    ABarCodeisprintedonthebottomofeverytestdevicetoidentifythereagentlotnumberandtoprevent
    theuseofexpiredreagents.
    
    SoftwareQualityAssurance
    ThesoftwareQAiscontrolledthroughavarietyofsoftwarefeatures,someofwhichcanbeoptional
    dependingontheenvironmentinwhichtheassayisperformed.InaPointͲofͲCarelocation,adesignated
    supervisorcanselectprogramparameterstoensureadherencetoqualitystandards.Inacentrallaboratory
    location,selectedparameterscanbebypassedifdesired.
    
    ASupervisorCODECHIPmoduleisprovidedwitheachmeter.ThisCODECHIPmoduleallowsaccessto
    meterfunctionsnotavailabletotheroutineuser.Theadditionalfunctionsareselectionofparameter
    settingsanddownloadinganddeletionofresultsfromthemetermemory.
    
    AUserIDcanbeassignedinthesoftwaretolimitaccesstothepatienttestingmodetoonlythose
    individualswhohavebeenproperlytrainedandhavedemonstratedtestingproficiency.AUserIDand
    expirationdateareprogrammedintothemetermemoryandaresubsequentlyassociatedwithallpatient
    resultsgeneratedbytheuser.Thisallowsthesupervisortoreviewusers’testingfrequency,andintheevent
    offrequenttestfailures,toidentifypotentialproblemsintraining.
    
    AnadditionalsecurityfeatureoftheUserIDisthepartialmaskingoftheIDondisplaysandprintouts.This
    preventsunauthorizedindividualsfromdetectingandusinganexistingUserID.Thisfeatureisoverridden
    whentheSupervisorCODECHIPmoduleisinstalled.
    

    Page73of86
    APatientIDisrequiredforallpatienttestsperformed.AllQCsampleandpatientresultsarestoredinthe
    meter’smemoryandcanbedownloadedtoalaboratoryinformationsystem(LIS)oranexternaldata
    managementsoftwareprogramforfurtherviewingandprintingofqualitycontrolreports.
    
    TheSupervisorcanselecttheQCFrequencyforperformingexternalliquidcontrolsamples.Whenitistime
    toperformexternalQCsamples,theusermusttesttheexternalliquidcontrolsandobtainacceptable
    resultsbeforepatientsamplescanbetested.WhenQCsampleshavebeensuccessfullyperformed,theuser
    isallowedtoperformtestsonpatientsamples.IfQCsamplesarenotwithinanacceptablerange,aQC
    Lockoutfunctionpreventstestingofpatientsamples.Ifdesired,thesupervisorinacentrallabsettingcan
    bypassthisfunction.Iftestdevicecontrolsareoutofrange,aQCLockoutfunctionisactivatedandpatient
    testresultsareblockedfromviewingandprinting.Thispreventsunacceptableresultstobecommunicated
    toandusedbythephysician.
    
    Additionally,iftestdevicesareexpired,aQCLockoutfunctionisactivatedandpreventstestingusing
    expiredtestdevices.
    
    QualityControlSamples
    Itisstillvaluabletoapplythetraditionalapproachtoqualitycontrolbytestingqualitycontrolsamples.
    Thesecontrolswillcheckthetotalintegrityofthesystem.Theintervalforanalyzingthesecontrols,
    however,canbeextendedduetothemanyotherTotalQualityAssurancefeaturesinherentintheQuidel
    Triagetests.
    
    TheQuidelTriagetestshavebeendesignedtomaximizeTotalQualityAssuranceinanytestingenvironment.
    ThecombinationoftheQCfeaturesoftheQuidelTriagetestsreducetheimpactofproceduralerrors,
    ensurereagentintegrity,andassurethatpatientresultsareaccurateeachandeverytimeatestis
    performed.BasedonthecurrentCLIAguidelinesandotherregulatingbodies,Quidelmakesthefollowing
    QCrecommendations:
    „ RuntwolevelsorPOSandNEGexternalliquidcontrolsamplesasappropriatewitheachnewlotof
    reagentsandonceeverythirtydayswithcontinueduseofthesamereagentlotnumber
    „ RuntheQCDevicedaily.
    
    NotesRegardingSoftwareControls
    1. UserIDAccess
    „ Topreventuntrainedpersonsfromperformingatest,avalidUserID(1Ͳ16charactersinlength)
    mustbeenteredbeforeaccessisgiventotheRUNTESTfunctioniftheUserIDbypassisOFF.Ifa
    UserIDBypassisON,thenanyonecananalyzeatest.
    „ Topreventunauthorizedpersonsfromaccessingpatientinformation,avalidUserIDmustbe
    enteredbeforeaccessisgiventotheRECALLPATIENTRESULTSfunctionsiftheUserIDbypassis
    OFF.IfaUserIDBypassisON,thenanyonecanrecallpatientdata.RECALLPATIENTRESULTS
    functionsincluderecallingpatientresults,printingpatientresults,andrecallingthelasttestrunon
    themeterwhenthelasttestisapatientsample,
    „ TheUserIDBypassiscontrolledbytheSETPARAMETERSfunction,whichrequiresaSupervisor
    CODECHIPmoduleforaccess.
    „ AccessisavailabletoanyonewantingtoRECALLNONͲPATIENTRESULTSfrommemoryorINSTALL
    CODECHIP.
    2. OutͲofͲRangeFlags

    Page74of86
    „ Ifapatientisoutsidethenormalrangeforanyoftheanalytes,thentheresultwillbeflaggedby
    reversevideo,thatis,thebackgroundoftheresultwillbeblackandthevalueinwhitenumbers.A
    warningwillbedisplayedbelowtheresults:
    PATIENTRESULTABNORMAL
    „ IftheInternalQCzonesforthedeviceoraspecificanalyteareunacceptable,theanalyte(s)in
    questiondisplayanexclamationpoint(!)inplaceofavalueandawarningisdisplayed:
    !INTERNALQCOUTOFRANGE.
    „ IftheQCSampleforaspecificanalyteonthatdevicelotisunacceptable,theanalyteinquestionwill
    displayapoundsign(#)inplaceofavalueandawarningisdisplayed:
    #QCSAMPLEOUTOFRANGE.
    „ IfbothQCSampleandInternalQCerrorsarepresentforaspecificanalyte,bothapoundsignandan
    exclamationpoint(#!)willbedisplayedinplaceofavalueandbothwarningsaredisplayed:
    !INTERNALQCOUTOFRANGEand#QCSAMPLEOUTOFRANGE.
    3. BlockedResults
    WhenQCerrorconditionsexistonatestdevice,whetherforaspecificanalyteortheentiretestpanel,
    theanalytesinquestionareblockedfromviewandreplacedwithanOutofRangeFlag(!and/or#).The
    errorconditionmustberemediedandthetestrepeatedtoobtainaresult.
    4. QCSampleFrequency
    „ Howoftenanexternalliquidcontrol,QCSample,shouldberuncanbeselectedunderSET
    PARAMETERS.Ifthetimeintervalhasexpired,QCSamplesmustberunandacceptableresults
    obtainedbeforeapatientsamplecanbetested.
    „ AlistoftestdevicelotsandthedatethattheQCSampleexpirescanbeviewedandprintedby
    selectingREAGENTLOTS–QCundertheRECALLRESULTSmenu.
    5. SupervisorAccess
    Topreventmisuse,theSupervisorCODECHIPmoduleisrequiredforaccesstotheSETPARAMETERSand
    DELETERESULTSfunctionsofthesoftware.TheSupervisorCODECHIPisuniversalandmaybeusedonany
    QuidelTriageMeterPro.
    
    LimitedWarranty.FORTHEAPPLICABLEWARRANTYPERIOD,QUIDELWARRANTSTHATEACHPRODUCT
    SHALLBE(I)OFGOODQUALITYANDFREEOFMATERIALDEFECTS,(II)FUNCTIONINACCORDANCEWITHTHE
    MATERIALSPECIFICATIONSREFERENCEDINTHEPRODUCTMANUAL,AND(III)APPROVEDBYTHEPROPER
    GOVERNMENTALAGENCIESREQUIREDFORTHESALEOFPRODUCTSFORTHEIRINTENDEDUSE
    (the“LIMITEDWARRANTY”).IFTHEPRODUCTFAILSTOMEETTHEREQUIREMENTSOFTHELIMITED
    WARRANTY,THENASCUSTOMER’SSOLEREMEDY,QUIDELSHALLEITHERREPAIRORREPLACE,ATQUIDEL'S
    DISCRETION,THEPRODUCT.EXCEPTFORTHELIMITEDWARRANTYSTATEDINTHISSECTION,QUIDEL
    DISCLAIMSANYANDALLWARRANTIES,EXPRESSORIMPLIED,INCLUDINGBUTNOTLIMITEDTO,ANY
    WARRANTYOFMERCHANTABILITY,FITNESSFORAPARTICULARPURPOSEANDNONͲINFRINGEMENT
    REGARDINGTHEPRODUCT.QUIDEL'SMAXIMUMLIABILITYWITHANYCUSTOMERCLAIMSHALLNOT
    EXCEEDTHENETPRODUCTPRICEPAIDBYCUSTOMER.NEITHERPARTYSHALLBELIABLETOTHEOTHER
    PARTYFORSPECIAL,INCIDENTALORCONSEQUENTIALDAMAGES,INCLUDING,WITHOUTLIMITATION,LOSS
    OFBUSINESS,PROFITS,DATAORREVENUE,EVENIFAPARTYRECEIVESNOTICEINADVANCETHATTHESE
    KINDSOFDAMAGESMIGHTRESULT.
    
    TheLimitedWarrantyaboveshallnotapplyiftheCustomerhassubjectedtheProducttophysicalabuse,
    misuse,abnormaluse,useinconsistentwiththeProductManualorInsert,fraud,tampering,unusual
    physicalstress,negligenceoraccidents.AnywarrantyclaimbyCustomerpursuanttotheLimitedWarranty
    shallbemadeinwritingwithintheapplicableLimitedWarrantyperiod. 

    Page75of86
    Appendices
    
    AppendixASpecifications
    
    Physical 
     Size 8.5”x6.25“x2.75”(22.5cmx19cmx7cm)DxWxH
     Weight 1.5pounds(0.7kg)withoutbatteries
     Electrical 6vDCat1amp–suppliedvia4AAbatteriesorAC/DCConverter
     Keypad Numericwithspecialfunctionkeys(22total)
    Environmental
     Temperature 15ºC–30ºC
     Humidity 10%–85%
     Location Dry,clean,flathorizontalsurfaceawayfromdirectsunlight
    Optical
     LightSource LaserDiode–<1milliwatt
     LaserClassification 1
     Detector SiliconPhotodiode
    MemoryCapacity
     750PatientRecords 32ReagentLotCODECHIPmodules
     200QCSampleResults 200QCSampleCODECHIPmodules
     70QCDeviceResults 4QCDeviceCODECHIPmodules
     250MiscTestResults 
     600UserID's 

    Miscellaneous
     RSͲ232computerinterfaceport
     ThermalPrinter
     LCDscreendisplay

    Options
    „ ExternalBarCodeReader(rapidentryofUser,Patient,AuxiliaryorMiscTestID's).
    „ QuidelTriageCensusDataManagementSoftware.
    „ QuidelTriageCensusDataManagementSoftwarewithLISConnectivity.

    TestDeviceSpecifications
    Testdevicespecificinformationisprovidedintheapplicableproductinsert.Theinstrumentanalyzes
    immunoassaytestdevicesmanufacturedbyQuidelCardiovascularInc.

    Page76of86
    AppendixBTroubleshooting
    MeterSymptoms
    Symptom ProbableCause CorrectiveAction
    a. Inappropriatebodyfluidor a. Retestsampleusinganewtestdevice
    InvalidResults
    improperlyanticoagulatedsample. withaproperspecimen.
    b. Retestsampleonanewtestdevice.
    b. Samplesizeincorrect—toolittle Makesuretheentiretubeisfull.Be
     sample.Testdevice’sinternalQC certainthelowerbulbonthepipette
    controlswillbeoutofrange. tubecontainsasmallamountfluid
    beforeyoupressthetopbulb.
    c. Iflessthan30minuteshaspassedsince
    c. Meterwaspickeduporcarried preparingthetestdevice,placemeter
    verticallywhiletestwasrunning. onflatsurfaceandreinsertthetest
    
    Thetestdevice’sinternalQC device.Ifmorethan30minuteshas
    controlswillbeoutofrange. passed,retestsampleonnewtest
    device.
    Ifmeterrepeatedlyfailstopullthedevice
    Meterwillnotpull Hookthatpullstestdeviceintothe
    in,themetermayneedtobereplaced.
    testdevicein. metermaybebroken.
    ContactQuidel.
    CODECHIPmodule a. CODECHIPmodulemayhavebeen a. ReͲinsertCODECHIPmodulerightside
    willnotfitinmeter. insertedupsidedown. up.
    b. TrynewCODECHIPmodule,if
    b. CODECHIPmoduleorMeter
     available.Ifstillnotagoodfit,contact
    contactscouldbebent.
    Quidel.
    Printerworksbutno
    printappearson Papermaybeinstalledbackwards. Installpaperreversetocurrentposition.
    paper.
    Carefullyremoveoldpaperoutofthe
    Papermayhavebeenfedintothe
    Printerjam. printer.Donotinsertanytoolsintothe
    meterimproperly.
    printer.
    Printerstops
    Replacebatteriesorverifypowercordis
    printing Batterypowerlow.
    installedinthemeterandwalloutlet.
    orskipsaline.
    Meterwillnot
    a. Verifybatteriesareinstalledand
    poweronormeter a. Batteriesnotinstalled,drainedor
    correctlyaligned(+)and(Ͳ);replace
    powersoffwhen incorrectlyaligned.
    batteriesifnecessary.
    runningatest.
    b. Verifypowercordisinstalledinthe
     b. Powersourcenotpluggedin.
    meterandwalloutlet.
    Blinkingbattery
    Lowbatterypower. Replacebatteries.
    icon. 
    Metercontainsno
    batteriesor
    AlldataissavedintheMeterexceptdate
    batteriesarelow 
    andtime.Resetdateandtime.
    whenfacilityhas
    lossofpower.
    
    
    
     Page77of86

    
    AppendixBTroubleshooting
    MeterMessageorSymptom
    Message ProbableCause CorrectiveAction
    Patientsampleconcentrationisabove Seeinstructionsthatcameintheboxof
    >XXX.X
    thedynamicrange. testdevicesorcontactQuidel.
    Patientresultisbelowthedynamic
    rangeorisaconcentrationbelowthe Forsomeparameters,a0.0ng/mlpatient
    <XX.X
    statisticallydeterminedlowesttest resultmaybeappropriate.
    concentration.
    Replacewith4ͲAAbatteriesorusetheAC
    BatteryLow. Batteriesneedreplacement.
    poweradapterasapowersource.
    Damagedbarcodeormeterhookmay Lookforparticlesonthebarcodeofthe
    CannotReadBar
    bebroken.(Themeterhookpullsthe testdevice.wipeoffwithadrycloth.
    Code
    testdeviceintothemeter.) Repeatthetest.
    a. • EnsureCODECHIPmoduleis
    completely inserted.
     • TryareagentCODECHIPmodulefrom
    adifferentboxofdevicesofthesamelot
    a. CODECHIPmoduleerror.
    number.
     • IfanewCODECHIPmoduleeliminates
    CannotRead
    themessage,theoriginalCODECHIPisat
    CodeChip.
    fault,discardCODECHIPmodule.
    b. IfthenewCODECHIPmoduledoesnot
    work,installaknownworkingCODE
    b. Metererror CHIPmoduletoverifyproperoperation.
    IftheCODECHIPmodulefailstowork,
    contactQuidel.
    Powermeteroffandwait15seconds.
    OpticsDetectordidnotproperlypower
    DetectorFailure Powermeteron.Ifmessagefailstoclear,
    on.
    contactQuidel.
    a. Inappropriatebodyfluidor a. Retestsampleusingnewdevicewitha
    improperlyanticoagulatedsample. properspecimen.
    b. Retestsampleonnewdevice.Becertain
    b. Samplesizeincorrect–toolittle thelowerbulbonpipetcontainsasmall
    sample. amountoffluidandtheentiretubeisfull
    beforedispensingcontents.
    c. Retestsampleandleavemeteronbench
    Measurement c. Meterpickeduporcarriedvertically topwhileperformingassay.Ifmorethan
    Failure. whiletestisrunning. 30minutessinceinoculation,useanew
    device.
    d. Possiblyduetocolddevicesorsample,
    highhematocritwithawholeblood
    sample,ormechanicalissuewithdevice.
    d. Samplerunningslowly
    Havecustomerimmediatelyreinsert
    deviceintometer(ifwithin30minutes
    
    ofsampleaddition).
    

    
    
    
    
    Page78of86
    Message ProbableCause CorrectiveAction
    Motorceasestofunction.
    Ejectandinspectthedeviceforanysticky
    • Metermaysloworstopduetoobject
    substances,labelsontopofthedeviceor
    lodgedontheMetertrack.
    MotorFailure. otheritemsthatmayinterferewiththe
    
    meter.Ifproblempersists,contact
    • Testdevicemaystickonthemeter
    Quidel.
    track.
    InstalltheCODECHIPmoduleincludedin
    NoDeviceDatain ReagentCODECHIPmodulehasnotbeen
    theboxoftestdevices(theReagent
    Memory. installed.
    CODECHIPmodule).
    a. Powermeteroffthenonagain.If
    OPTICFAILUREmessageclears,run
    a. Internalstandardisoutof
    theQCDevicetoverifyproper
    specification.
    operation.Ifmessagefailstoclear,
    OpticFailure.
    contactQuidel.
    b. Powermeteroff.Allowmetertositat
    b. Meterexposedtoextreme
    roomtemperaturefor1–2hours.
    temperatures.
    Powermeterbackon.
    ProgramCheckOK.
    PressENTERtostart MessageappearswhentheON/OFF
    existingprogramor buttonispressedwhenthemeterhas PresstheENTERkey.
    pressEXITtoloada beenwithoutpower.
    newprogram.
    QCDevice— a. CleanQCDevicewithalintͲfreecloth
    a. Maybeduetolintordustaffecting
    calibration, orspraywithcannedairandrepeat
    reading.
    alignmentorlaser thetest.
    failed. b. QCDeviceshouldberunregularly
    Messages: evenifpatientsamplesarenotrun.
    CalibPass(orFail) b. QCDevicewasnotrunregularly.
    LaserPass(orFail) c. Ifproblempersists,contactQuidel.
    AlignPass(orFail)
    Resettimeanddateifrequired.Check
    Time/Dateisblinking Metertemporarilylostallpower. theAC/DCpowerconverterplugand
    batteries.
    Warningindicatesthattheinternal
    qualitycontrolonthetestdevicewasout
    Warning:InternalQC Repeatsampleusinganewtestdevice.If
    ofrange.
    OutofRange problempersists,contactQuidel.
    Thismaybesamplespecific.
    Thismaybedevicerelated.
    Options:
    Messageisdisplayedwhenmeteris
    Warning:Patient a. Printallresults.
    turnedonifthereisspaceleftforless
    MemoryhasSpace b. Deletepatientresults.
    than100patientrecordsorspaceleftfor
    for###More c. Noactionisrequiredasthemeter
    lessthan20patientrecordswhen
    Records. willdeletetheoldestresultoncethe
    runningpatientsample.
    
    memoryisfull.
    
    
    
    
    Page79of86
    AppendixCReturnandDisposalProcedures
    ReturnProcedure
    Shouldamalfunctionoccur,contactQuidel.IfQuideldeterminesthatthemetershouldbereturned,youwill
    beassignedareturnauthorizationnumberandbeprovidedshippinginstructions.
    
    Immediatelyafterthereturnhasbeenauthorized,QuidelwillsendoutareplacementQuidelTriage
    MeterPro.ReturnthemalfunctioningmetertoQuidel.Notethereturnauthorizationnumberonboththe
    shippingboxandtheairbillandsendthemeterbacktoQuidelassoonaspossiblefollowingreceiptofthe
    replacementmeter.
    
    DisposalProcedure
    Theproductmaycomeintocontactwithbloodduringtesting.Usedproductsthereforecarryariskof
    infection.Whendisposingofameterthathasbeenutilized,pleasedosoinaccordancetotheregulations
    applicableinyourcountry.Forinformationaboutcorrectdisposal,pleasecontactyourlocalcouncilor
    authority.TheproductfallsoutsidethescopeoftheEuropeanDirective2002/96/EC(directiveonWaste
    ElectricalandElectronicEquipment(WEEE)).
    
    
    AppendixDGlossary
    Analyte:Chemicalsubstancebeingmeasured.

    Assay:Test.

    Calibration:Comparisonofresulttoareferencestandard.

    Character:Onepartofalongerstringoflettersandnumbers;forexample,inthestring"ABC",theA,B,
    andCareeachacharacter.

    CODECHIPModule:Anyofseveralkindsofchipsbearinginformationthatcanbedownloadedinthe
    QuidelTriageMeterPro,includingReagent,QCSample,QCDevice,SupervisorandProgram.

    CODECHIPModulePort:ThesmallslotontheunderneathsideoftheQuidelTriageMeterProwherea
    CODECHIPmodulecanbeinserted.

    Dateformats:DDͲMMͲYY:DayͲMonthͲYear
    MMͲDDͲYY:MonthͲDayͲYear
    YYͲMMͲDD:YearͲMonthͲDay

    NOTE:AllpartsofdatesshouldbegivenastwoͲdigitnumbers.Forexample,themonthofMayis05.
    
    DeviceL/N:Lotnumberofatestdevicecanbefoundonthesideoftheboxthatcontainsthetestdevices
    andoneachtestdevice.ThedeviceL/NisafiveͲdigitnumberthatmaybeprecededbyoneormoreletters.
    Themeterdisregardsallletters.

    Digit:Onepartofalongernumber;forexample,inthenumber231,the2,3,and1areeachadigit.

    Fluorescence:Thecharacteristicofachemicalsubstancethatenablesittogiveofflightwhenstimulated.

    Page80of86
    ID:Identification.

    Immunoassay:Atestthatusesantibodiestomeasuresubstances.

    InternalQC:QualitycontrolsinplaceaspartoftheQuidelTriageMeterPro’ssoftwareorzonesbuiltinto
    thetestdevice.

    Invitro:Madetooccurinalaboratoryvesselorothercontrolledexperimentalenvironmentratherthanin
    alivingorganism(literally,inglass).

    Invitrodiagnosticuse:Foruseinacontrolledsetting.

    Laserdiode:LightsourceusedintheQuidelTriageMeterPro.

    LCD:Liquidcrystaldisplay;thescreenontheQuidelTriageMeterPro.Showsthemenuofpossibletestsand
    proceduresandpromptstheoperatortotakethenextstep.

    Lotnumber:L/N;identificationnumbergiventoagroupoftestdevices.

    L/N:Lotnumber;thenumberthatidentifiesabatchof
    testdevices.
    Menu:ListofchoicesdisplayedontheQuidelTriage
    MeterPro’sscreen.

    MMX:TheMultiMarkerIndexvalue,isanumber
    calculatedfromthemeasuredvaluesoftheanalytesin
    aTestDevice.NotallQuidelTriagetestpanelshave
    theMMXfeature.

    Parameters:Options;functions

    Photodiode:DetectsthelightemittedfromthefluorescentdyeinthetestdevicesusedintheQuidelTriage
    MeterPro.

    PointofCare(POC):Notinalaboratory;attheplacewherecareisbeinggiventoapatient.

    QC:QualityControl.

    QCSample:Externalcontrols;aliquidsolutioncontainingchemicalsthat,whendispensedintoatest
    device,reactwiththetestreagents.Usedtoverifyproperperformanceoftestdevicesaftershipmentor
    longperiodsofstorage.

    QCSampleCODECHIPmodule:CODECHIPmodulethatcanbedownloadedintotheQuidelTriage
    MeterPromemorytogivethemeterinformationneededaboutthespecificlotofQCSample.

    QCDevice(previouslycalledQCSimulator):
    Testdevicecontaining6independentzonesthatverifiesproperoperationofthe
    QuidelTriageMeterPro’sabilitytoproperlyreadpatienttestsacrossvaryinganalyte
    concentrations.

    QCDeviceCODECHIP:CODECHIPmodulethatcanbedownloadedintotheQuidel
    TriageMeterPro’smemorytogivethemeterinformationneededaboutthespecificQCDevice’s
    performanceintheassignedmeter.

    Page81of86
    Quantify,quantifying:Togivetheresultsofatestasnumber.

    Reagent:Substancethatcauseschemicalreactions;usedinanalysis.

    ReagentCODECHIPmodule:CODECHIPTMmoduleloadedwithinformationaboutaspecifictestandlot
    number.

    Retrieve:Find,bringback.

    ReverseVideo:Lighttextdisplayedonadarkbackground.

    Screen:ThepartoftheQuidelTriageMeterProthatdisplayswordsandnumbers.

    Scrollto:Usearrowkeys

       
    togototheinformationyouwantonthescreen.

    SetParameters:AfunctionoftheQuidelTriageMeterPro;requirestheuseoftheSupervisorCODECHIP
    module.

    SoftwareUpgradeCODECHIP:
    CODECHIPmoduleusedtodownloadnewsoftwareontotheQuidelTriageMeterPro.

    SupervisorCODECHIPmodule:TheCODECHIPmodulethatallowsasupervisortoset
    parametersanddeleteresults.

    Testdevice:Holdsthesample(forexample,blood)fromthepatientsothatitcanbeinserted
    intotheQuidelTriageMeterProfortesting.Containsreagentzonesthatcausereactionsto
    occurthatallowthemetertodetermineanalytelevelsinthepatient.

    Testpanel:AlternatenameforTestDevice,usuallyindicativeofaTestDevicewithmultipleanalytes.
    
    
    AppendixESampleLogSheets
    Thefollowinglogsheetsareprovidedasalternatemethodsoftrackingtestresults.
    TheQuidelTriageMeterProiscapableoftrackingandprintingouttesthistoryandprovidingQCLockouts
    topreventpatienttestingwhenoutsideQCrequirements.
     

    Page82of86
    

    Page83of86
    

    Page84of86
    Page85of86
    
    
    
    55070–QuidelTriageMeterPro
     55071–QuidelTriageMeterPro
    
    
    
     

    
    

    
    MDSSGmBH
    Schiffgraben41
    30175Hannover,
    
    Germany
    

    
    QuidelCardiovascularInc.
    9975SummersRidgeDrive ENSRC26611enA
    SanDiego,CA92121USA PN:26611enRev.A2018/03
    quidel.com 
    
    
    RevisionChanges:
    InitialreleaseforQuidelCardiovascularInc.
    

    Page86of86

    You might also like