Quidel Triage MeterPro User Manual

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UserManual

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TableofContents

TableofContents............................................................................................................................................2

GeneralInformation............................................................................................................................................5

QuidelContactInformation.............................................................................................................................5

MainMenuStructure......................................................................................................................................6

LabelsandSymbols.........................................................................................................................................7

Warnings,PrecautionsandLimitations...........................................................................................................9

Introduction.......................................................................................................................................................10

HowtoUseThisGuide..................................................................................................................................10

Description............................................................................................................................... .....................10

WhatistheQuidel

TriageMeterPro?.......................................................................................................10

Unpacking..................................................................................................................................................11

Installation.........................................................................................................................................................15

UnpackMeter............................................................................................................................... .................15

PowerMeterOn............................................................................................................................... .........15

InstallPaper............................................................................................................................... ................16

InsertSupervisorCodeChipModule.........................................................................................................17

ToChangeMeterSettings.........................................................................................................................17

ChangeClock.............................................................................................................................................19

SetUserID.................................................................................................................................................20

ChangeReference

Ranges/ThresholdsforTests:......................................................................................20

ChangeTestSettings.................................................................................................................................20

ChangeQCParameters..............................................................................................................................21

ChangeBypassSettings.............................................................................................................................21

SetParameters............................................................................................................................... ...............23

Purpose............................................................................................................................... .......................23

ListofProgrammableParameters.............................................................................................................23

SupervisorAccess......................................................................................................................................23

HowtoSetParameters:BasicInstructions...................................................................................................24

MeterSettings...........................................................................................................................................

25

IDSettings..................................................................................................................................................25

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Asymbolsglossarycanbefoundatquidel.com/glossary.

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InstallCodeChip............................................................................................................................................37

Purpose............................................................................................................................... .......................37

TypesofCODECHIPmodules.................................................................................................................... 37

InstallationofReagent,QCSampleorQCDeviceCODECHIPModules...................................................37

Operation..........................................................................................................................................................39

AccesstotheQuidelTriageMeterPro..........................................................................................................39

RunTest............................................................................................................................... ..........................39

Purpose............................................................................................................................... .......................39

Options............................................................................................................................... .......................

39

RecallResults............................................................................................................................... ..................49

Purpose............................................................................................................................... .......................49

Function.....................................................................................................................................................49

LastRecord............................................................................................................................... .................49

PatientResults...........................................................................................................................................50

PatientID...................................................................................................................................................50

TestDeviceLotNumber(L/N)...................................................................................................................51

UserID............................................................................................................................... ........................52

FromDate..................................................................................................................................................52

TillDate......................................................................................................................................................53

QCResults............................................................................................................................... ...................

54

QCSampleLotNumber(L/N).................................................................................................................... 55

DeviceLotNumber(L/N)........................................................................................................................... 55

UserID............................................................................................................................... ........................56

FromDate..................................................................................................................................................57

TillDate......................................................................................................................................................57

ReagentLots–QC............................................................................................................................... ......58

ArchiveLastTest............................................................................................................................... .........58

Misc.TestResults............................................................................................................................... .......59

Misc.TestID..............................................................................................................................................59

TestDeviceLotNumber(L/N)...................................................................................................................60

UserID............................................................................................................................... ........................61

FromDate..................................................................................................................................................61

TillDate......................................................................................................................................................62

PrintAllResults............................................................................................................................... ...........63

PatientResults...........................................................................................................................................63

QCSampleResults.....................................................................................................................................63

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QCDeviceResults......................................................................................................................................64

Misc.TestResults............................................................................................................................... .......64

UploadResultstoLIS............................................................................................................................... ..64

DeleteResults................................................................................................................................................64

Purpose............................................................................................................................... .......................64

TheQuidelTriageMeterProMemory.......................................................................................................65

DeletePatientResult............................................................................................................................... ..65

DisplayBacklight............................................................................................................................................66

AlphaNumericMode....................................................................................................................................67

ServiceandMaintenance

Procedures............................................................................................................... 68

PaperReplacement............................................................................................................................... ........68

ChangingPaperBetweenFunctions..........................................................................................................68

ChangingPaperWhilePrinting..................................................................................................................69

Cleaning............................................................................................................................... ..........................70

CheckBatteryLevel............................................................................................................................... ........70

BatteryReplacement............................................................................................................................... ..70

TotalQualityAssurance............................................................................................................................... ..71

Introduction...............................................................................................................................................71

QualityAssuranceFunctions.....................................................................................................................72

InternalDeviceQuality

Assurance............................................................................................................72

MeterQualityAssurance...........................................................................................................................73

SoftwareQualityAssurance......................................................................................................................73

QualityControlSamples............................................................................................................................74

NotesRegardingSoftwareControls.......................................................................................................... 74

Appendices............................................................................................................................... .........................76

AppendixASpecifications.............................................................................................................................76

MeterSymptoms............................................................................................................................... ........77

AppendixBTroubleshooting......................................................................................................................... 78

MeterMessageorSymptom..................................................................................................................... 78

AppendixCReturn

andDisposalProcedures................................................................................................80

ReturnProcedure............................................................................................................................... .......80

DisposalProcedure............................................................................................................................... .....80

AppendixDGlossary............................................................................................................................... .......80

AppendixESampleLogSheets...................................................................................................................... 82

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GeneralInformation

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QuidelContactInformation

ContactQuidelTechnicalSupportfrom7:00a.m.to5:00p.m.PacificTime

Tel: 800.874.1517(intheU.S.);

858.552.1100(outsidetheU.S.)

Fax: 858.552.7905

Email: [email protected]orcontactyourlocaldistributor

Website: quidel.com



IfoutsidetheU.S.contactlocaldistributororoneoftheTechnicalSupportcenterslistedbelow.Youmay

alsocontactusatquidel.com.

Region

Phone EͲmailAddress

EuropeandMiddleEast +44.161.483.9032 [email protected]

AsiaPacific +61.7.3363.7711 [email protected]

Africa,RussiaandCIS +972.8.9429.683 [email protected] 

LatinAmerica +57.2.6618797 [email protected]

Canada +1.613.271.1144 [email protected]

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MainMenuStructure





RunTe st RecallRes ults

InstallNew

CODECHIP

Set

Parameters*

Delete

Results*

QC

Sample

Misc.

Test

QC

Device

Patient

Sample

Patient

Samples

Misc.

Test

Results

QC

Results

Last

Record

PrintAll

Results

Upload

Results

toLIS

x QCSampleResult s

x QCDeviceResults

x Reag ent Lots–QC

x ArchiveLastTest

UserID RangesClock

Meter

Settings

Test

Settings

QC

Parameters

Bypass

x NewUserID

x UpdateUserID

x Delet eUserID

x UserIDList

x QCDeviceFreq.

x QCSampleFreq.

x NumberofControls

x NumQua ntStdDevs

Display

Settings

Comm

Settings

ID

Settings

x CharactersUserID

x CharactersPat.ID

x CharactersAux.ID

x Aux.IDEnable/Disable

x CharactersMisc.ID

x Bau dRate

x Pat.ResultApproval

x LISEnable/Disable

x AutoUpload

x Language

x PrintMode

x AutoPowerͲOff

x Displa yContras t

x PrinterContras t

*SupervisorCODECHIPOnly

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LabelsandSymbols

Label/Symbol Description



Manufacturer



Invitrodiagnosticmedicaldevice



Consultinstructionsforuse



AuthorizedrepresentativeintheEuropeanCommunity



Temperaturelimitation



Humiditylimitation



Wasteelectricalandelectronicequip m ent(WEEE)



SerialNumber



CatalogNumber



Warning/Caution



Important





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CEmark



Batchcode



Dateofmanufacture



UseͲbydate



Intendeduse



Upperlimitoftemperature



DonotreͲuse



ChinaRoHS



Patientnumber



Testdevice



Control



CalibrationVerification



Prescriptionuseonly



Contents/contains



Expectedvalues



Biologicalrisks



Thaw



Transferpipette



Mean



Standarddeviation



CODECHIPmodule



PrinterPaper



Peelopenhere





Addsamplehere



UseEDTAplasmasampleonly



Useurinesampleonly



UseEDTAwholebloodorplasma

sampleonly



Addsampleimmediatelyafter

openingfoilpouch



 

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Warnings,PrecautionsandLimitations

 TheQuidelTriageMeterPromustbeusedwithintheoperatingtemperaturerangerequiredbythe

specifictestdeviceproductbeingused.Refertothetestdevicepackageinsertfordetails.



 OperatetheQuidelTriageMeterProonalevel,drysurfaceawayfromdirectsunlight.



 TheQCDevice

islightͲsensitiveandshould bestoredinitsblackopaquecasewhennotinuse.



 DoNOTwriteorplacealabelanywhereontheQCdevice,asitmayinterferewiththedevice

functionality.



 DonotmovetheQuidelTriageMeterProwhileatestis

inprogress.



 Ensureallsamplefluidshaveabsorbedintothetestdevicepriortorunningthetesttopreventinternal

contaminationofthemeter.



 UseonlytheAC/DCpoweradapterprovidedwiththeQuidelTriageMeterPro.Anidentifyingtaghas

beenplacedonthecordfor

quickidentification.



 DonotdropQuidel TriageMeterPro.



 DonotplaceobjectsontheQuidelTriageMeterPro.



 DonotimmersetheQuidelTriageMeterProinwateroranyliquids.



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Introduction



HowtoUseThisGuide

Thismanualcontains:

 InstructionsfortheoperationandmaintenanceoftheQuidelTriageMeterPro,and;

 Basicinstructionsfortestingsamples



TheQuidelTriageMeterProsoftwarehasbeendesignedtoprovidetheuserstepbystepinstructions.The

meterdisplaystestresultsandmenuoptionsintheupperhalf

ofthemeterscreen.Insmallerlettersatthe

bottomofeachscreen,themeterdisplaysinstructionspertainingtothetaskbeingperformed.



8:23AM01•20•18



RUNTEST

RECALLRESULTS

INSTALLNEWCODECHIP



SELECTWITHvOR^ANDPRESSENTER

PRESSEXITTOEJECTDEVICE



TheQuidelTriageMeterProUserManualisdividedintosixsections.

Section1– GeneralInformation:Contactinformation,MenuStructurefortheQuidelTriageMeterPro,

Symbols,WarningsandPrecautions

Section2–Introduction:ProvidesanoverviewoftheQuidelTriageMeterPro.

Section3– Installation:Guidestheuserthrough

firsttimesetup.

Section4– Operation:Guidestheuserthroughrunningtests,recalling resultsanddeletingresults.

Section5– ServiceandMaintenanceProcedures:PaperReplacement,Cleaning,Batteries,TotalQuality

Assurance,andWarranty.

Section6– Appendix:Specifications,Troubleshooting,ReturnandDisposal,Glossary,SampleLogSheets



Description

WhatistheQuidelTriageMeterPro?

TheQuidelTriageMeterProisaportablefluorescenceinstrumentusedtomeasuretheresultsoftests

manufacturedbyQuidelCardiovascularInc.TheQuidelTriageMeterProcanbeusedinalaboratoryorina

pointͲofͲcaresetting.



TheQuidelTriageMeterProusesalaserasalightsource.Light

fromthelaserhitsatestdevicethathas

beeninsertedinthemeter.Thiscauses thefluorescentdyeinthetestdevicetogiveoffenergy.Themore

energythefluorescentdyegivesoff,thestrongerthesignal.

NOTE:Torunspecifictests,suchastheQuidelTriageCardiacPanel,youalsowillneeddetailed

informationcontainedintheproductͲspecificPackageInsert,includedinthetestkit.

Page11of86



Overview:RunningaTest

Afteratestsample(forexample,blood)fromapatientisaddedtothetestdevice,thetestdeviceisinserted

intheQuidelTriageMeter P ro.Themetermeasureshowmuchofthesubstance(aparticularprotein

marker)ispresent,basedonstandardsthathavebeenpreͲprogra mmedintothemeter.

Thepatient

identification,theUserI.D.andthetestresultscanbeprintedoutonapapertape.



Inadditiontotestingsamplesfrompatients,theQuidelTriageMeterProcontainspreͲprogrammedQuality

Control(QC)functionsthatallowthepersonoperatingthemetertomonitorqualitycontrol.





Unpacking

TheQuidelTriageMeterProandtheitemsthatcomewithitareprovidedinasinglebox.

QuidelTriagetestdevicesarepackagedseparatelyandincludeinstructionsforrunningspecifictests.Ifyou

haveanyquestions,contactQuidel(refertotheAssistancesection).



TriageTestDevice.Atestdeviceholdsthe

sampleandalsocontainsthereagentsand

othermaterialsneededforthetest.

NOTE:TheQuidelTriageMeterProacceptstestdevicesthataredesignedspecificallyforusewiththe

QuidelTriageMeterPro.PleaserefertoproductͲspecificPackageInsertsincludedineachtestkitformore

information.

Page12of86

Contents

 QuidelTriageMeterPro

 QCDeviceandCODECHIPmodule(intheQCDevicebox)

 AC/DCPowerConverter

 AABatteries

 RollsofPrinterPaper(additionalrollsaresuppliedineachboxoftestdevices)

 SupervisorCODECHIPmoduleandCODECHIPmoduleBox





Printerpaper

locatedbelow

QCDevicebox.

Page13of86

PartsoftheQuidelTriageMeterPro



Page14of86



On/OffKey

(Powerbutton)



UsedtoturntheQuidelTriageMeterProonandoff.

PrintKey



Usedtoprintthetestresultsordisplayscreen.

DeleteKey



Usedtodeletedata.

EnterKey



Allowstheoperatortoselectmenuitemsandacknowledgealarm

conditions.

ExitKey



Usedtoexitthedisplayedmenuorejectthetestdevice.

BrightnessKey



Usedtosetscreenbrightness

Keypad



Usedtoenteridentificationnumbers,letters,andspecialsymbols.

ArrowKeys



Usedtotogglethroughmenuitems.

Up

Down

Left

Right

ShiftKey



SymbolKey



UsedwithShiftKey

ThermalPrinter



Printsthetestresultonpaper.

DataPort



Connectionpointforthe(optional)BarCodeScanner,allowingthe

operatortoscanpatientoruseridentificationdatainsteadofmanually

enteringnumbersorlettersonthekeypad.Mayalsobeusedtoconnect

toadatamanagementsystem/LIS.

PaperFeedKey



Usedtofeedpaper

CODECHIP

ModulePort



InsertionpointforCODECHIPmoduleswhichcontainlot/devicespecific

dataforuseinprovidingtestresults.

PowerSupplyPort  ConnectionpointforthesuppliedAC/ DCPowerConverter.

PrinterCover  Thecover,whichwhenpulledstraightup,revealsthepaperroll.

LCDScreen 

TheLCD(LiquidCrystalDisplay)Screenshowsthemenuofpossibletests

andtasksandpromptstheoperatortotakethenextstep.

ScreencommandsandoptionsareindicatedbyaBOLDEDFONT. 

Page15of86

Installation

UnpackMeter

a. Removethemeterfromtheboxandprotectiveplasticbag.



PowerMeterOn

Batteries

a. Turnthemeterover.

b. Removebatterycover.

c. Install4AAbatteries,payingattentiontobatteryorientationinthe

batterycompartment.

d. Replacebatterycoverandturnmeterrightsideup.

e. Powerthemeteronbypressingthekey.Pressthekey

torunselfͲtest.Whenthe

testiscompleted,thescreenmeter

displaywillcometorestatthemainmenu.



LowPowerIndicator



 8:23AM01•20•18



Timeanddate



Menuitems

UserInstructions

RUN

TEST

RECALLRESULTS

INSTALLNEWCODECHIP



SELECTWITHvOR^ANDPRESSENTER

PRESSEXITTOEJECTDEVICE

TheMainMenu



 

NOTE:TheLowPowerIndicatormonitorstheactivepowersource.Toverifyadequatebatterpower:

 NavigatetotheMainMenu

 RemovetheACpowersupply

 PresstheEXITkey(themeterattemptstoejectthedevice)

 ObservetheMainMenuonthemeter’sdisplay.

 Replacethebatteriesifthepowericonisvisible.

Page16of86

ACPowerSupply

a. Removethepowersupplyfromthebox.

b. PlugoneendintoanACoutlet.

c. Plugtheoppositeendintotheroundholeinthebackofthemeter.



InstallPaper

a. Removetheprintercoverbypullinguponthecoverasindicatedbythearrowonthebackofthecover.



FormoredetailsaboutInstallingPaperseetheCareandMaintenancesection.



b. Tearorcutaclean,straightedgetofeedintotheprinter.Donot

cutpaperatanangle,astheprinter

mustsensetheedgeofthepaperalongthefeedpath.



c. Positionthepapersuchthatthepaperwillfeedfromundertheroll(asopposedtooverthetopofthe

roll,seepicture).





NOTE:Theprintercontainsapapersensorandwillfeedthenewpaperrollonlywhenpaperwithaclean

straightlineispressedintothepaperroller.

Page17of86

d. Insertthepaperedgeunderthepaperroller(platen)untilitfirmlyseatsorresistanceisfelt.

e. Pressthekeytwice,paperwillfeedthroughtheprinterandextendoutthemeter.

f. Placetherollofpaperintothepapercompartment.

g. Replacetheprintercoverandcontinue

operation.



InsertSupervisorCodeChipModule

a. RemovetheSupervisorCODECHIPmoduleBoxfromthemeterbox.

b. RemovetheSupervisorCODECHIPmodulefromitsbox.

c. InserttheSupervisorCODECHIPmoduleintotheCODECHIPmodulePort.Theportislocatedontheleft

sideofthemeter,towardsthebottomfrontcorner.

NotetheorientationoftheCODECHIPmodule in

thedrawingbelow.

d. OncetheSupervisorCODECHIPmoduleisinstalled,verifythattwoadditionalmenuitemsappearonthe

displayscreen.



8:23AM01•20•18



RUNTEST

RECALLRESULTS

INSTALLNEWCODECHIP

Twoadditionalmenuoptions

accessiblewhenSupervisor

SETPARAMETERS

CODECHIPmoduleisinserted.

DELETERESULTS



SELECTWITHvOR^ANDPRESSENTER

PRESSEXITTOEJECTDEVICE

TheSupervisor’sMainMenu



FormoredetailsaboutCODECHIPmoduleseepage22.



ToChangeMeterSettings

a. SelectSETPARAMETERSusingthe



keysandpressthekey.

b. SelectMETERSETTINGSusingthekeysandpressthekey.

Page18of86

c. SelectIDSETTINGS,DISPLAYSETTINGSorCOMMSETTINGSusing

the



keysandpressthekey.

d. Selectthedesiredsettingusingthe



keysandchangethevalueofthesetting

byusingthe



keys.



IDSettings Default Options NewSettings



CHARACTERSUSERID Min1

Max16

1Ͳ16



CHARACTERSPAT.ID Min1

Max20

1Ͳ20



CHARACTERSAUXID Min1

Max12

1Ͳ12



CHARACTERSMISCID



Min1

Max20

1Ͳ20



AUX.IDENABLE/DISABLE Disabled Disabled,Enabled

Forreference,recordyoursettingsinthespaceprovided.



e. PressthekeytosavechangestoIDSe ttings.

DisplaySettings Default Options NewSettings

LANGUAGE English English,French,Italian,

German,Spanish,

Portuguese,Greek,

Danish,Swedish,

Japanese



PRINTMODE Automatic Automatic,Manual



AUTOPOWERͲOFF 2hour 1/2hour,1hour,2

hour,4hour,None



DISPLAYCONTRAST 4 0Ͳ8

(8=Heaviestcontrast)



PRINTERCONTRAST 4 0–8

(8=heaviestcontrast)



Forreference,recordyoursettingsinthespaceprovided.



Page19of86

f. PresstosavechangestoDisplaySettings.

COMMSettings Default Options NewSettings

BAUDRATE

  

PAT.RESULTAPPROVAL

'LVDEOHG (QDEOHG'LVDEOHG 

LISENABLE/DISABLE

'LVDEOHG 'LVDEOHG(QDEOHG 

AUTOUPLOAD

'LVDEOHG 'LVDEOHG(QDEOHG 

LISPASSWORD

 



g. PressthekeytosavechangestoCommunicationSettings.



h. PressthekeytosavechangestoMeterSettings. 



FormoredetailsaboutCommunications,includingentryofaQuidelprovided,meterspecificpassword,see

page29.



ChangeClock

a. SelectSETPARAMETERSusingthe



keysandpressthekey. 

b. SelectCLOCKusingthe



keysandpressthekey.

c. SelecttheHOUR:MINUTEareausingthe



keys.Typeinthecorrecttimeusingthenumber

keys.

d. PressthekeytomovetoAM

orPM.

e. SelectAMorPMusingthe



keys.

f. PressthekeytomovetoTIMEFORMAT.

g. SelectAM/PMor24HR.usingthe



keys.Ifselecting24HR.,thepreviouslyenteredHOUR:

MINUTEwillchangetoa24ͲhourformatandtheAM

orPMwilldisappear.

h. PressthekeytomovetotheDATE.

i. Typeinthe6ͲdigitdateaccordingtotheDATEFORMAT

belowit.

j. PressthekeytomovetotheDATEFORMAT.

k. SelectMMͲDDͲYY,DDͲMMͲYY

orYYͲMMͲDDusingthe



keys.ThepreviouslyenteredDATEchangesas

theDATEFORMATchanges.



l. Pressthekeytosavechanges.



Page20of86

Setting Default Options NewSettings

TIMEFORMAT AM/PM AM/PM;24HR.



DATEFORMAT MMͲDDͲYY MMͲDDͲYY,

DD.MM.YY,

YYͲMMͲDD



SetUserID

TheQuidelTriageMeterPronormallyrequiresaUserIDtobeenteredpriortorunningapatienttest,QC

test,orMisctest,andpriortorecallingpatientresults.Refertopage31forinstructions.Alternately,this

featuremaybebypassed.Seepage21.



ChangeReferenceRanges/ThresholdsforTests:

a. SelectSETPARAMETERSusingthe



keysandpressthekey. 

b. SelectRANGESusingthe



keysandpressthekey.

c. Selectthetestpaneltypeusingthe



keys.

d. Selecttheanalyteandlevelusingthe



keys.TypeinthenewvaluefortheHIGH

orLOWcutoff

asappropriate.

e. Pressthekeytosavechanges.

FormoredetailsaboutRangesSettingsseepage33.



ChangeTestSettings

a. SelectSETPARAMETERSusingthe



keysandpressthekey. 

b. SelectTESTSETTINGSusingthe



keysandpressthekey.

c. Selectthetestpaneltypeusingthe



keys.

d. Selecttheanalyteusingthe



keys.



e. Selectthetestsetting(ACTIV,INACT,USRA,orUSRI)usingthe



keys.

f. Pressthekeytosavechanges.

FormoredetailsaboutTestSettingsseepage34.

NOTE:ThelowestvalueoftheRangeorThresholdmaybedisabledforsometestpanels.Refertothe

appropriateProductInsertforspecificinformation.

NOTE:Theabilitytochangetestsettingsmaybedisabledforsometestsinspecificpanels.Refertothe

appropriateProductInsertforspecificinformation. 



Page21of86



ChangeQCParameters

a. SelectSETPARAMETERSusingthe



keysandpress .

b. SelectQCPARAMETERSusingthe



keysandpress .

c. Selectthedesiredsettingusingthe



keysandchangethevaluetotherightofthesettingby

usingthe



keys.



Setting Default Options NewSettings

 QCDEVICEFREQ. Daily None,8HR,Daily,

Weekly,Monthly



 QCSAMPLEFREQ. Monthly None,8HR,Daily,

Weekly,Monthly



 NUMBEROFCONTROLS 2 1or2 

 NUMQUANTSTDDEVS 3 2or3 



d. PressthekeytosavechangestoQCPARAMETERS.



FormoredetailsaboutQCParametersSettingsseepage35.



ChangeBypassSettings

a. SelectSETPARAMETERSusingthe



keysandpressthekey. 

b. SelectBYPASSusingthe



keysandpressthekey. 

c. ForUSERIDselectONorOFFusingthe



keys.

d. PressthekeytosavechangestotheBypasssetting.



Formoredetailsabout

BypassSettingsseepage

36.



Priortocommencingpatienttesting,removetheSupervisorCODECHIPmodulefromthemeter,returnit

tothestorageboxandplaceinasafeplaceforfutureuse.



ThemeterisnowreadytorunQCTestsinpreparationforPatientTesting.



QCTestingshouldbeperformedinthe

followingmanner:

1. RunQCDEVICE(seepage40).

2. RunQCSAMPLEforeachlotofdevices(seepage42).

3. Ifappropriate,runCALIBRATIONVERIFICATIONSETasaMiscTestsampleforeachtestpaneltypetobe

used.(RefertotheapplicableProcedureManualandCalibrationVerification

SetPackageInsertfor

detailedinstructions).



NOTE:



Ifthebypassis

ON,

theuserIDfeatureisdisabledand anyonemayrunatest.Ifthebypassis

OFF,

theuserID

featureisactiveandonlyauthorizedusersmayrunatest.ToInstallUserID's,seepage31.



Page22of86



Location

TheQuidelTriageMeterProshouldbeplacedonadry,clean,flat,horizontalsurfaceawayfromdirect

sunlight.



Power

TheQuidelTriageMeterProrequires6ͲvoltsDCsuppliedbyeitherACorDC.Themeterwill run

approximately100testsonbatteries.Itisrecommendedtousebatteriesasabackupintheeventofa

poweroutage.



CAUTION:Useonlythepowersupplyprovidedwiththemeter,failuretodosomaycausepermanentdamageto

themeter.



SelfͲTest

TheQuidelTriageMeterProchecksthesystemtobesureit isoperatingproperlybyrunningselfͲtestswhen

poweredonandpriortoeachtest.

 PowerOn–includeslaseroperation,internalstandardrange,batterypower,andsoftwareverification.

 EachTest–verifiesthelaseroperation,internalstandard

rangeandbatterypower.



CODECHIPModules

MeterdataisupdatedviaadisposableCODECHIPmodule.TheCODECHIPmodulecontainsmicrochip 

circuitryembeddedintoaplastichousing.WheninsertedintothemeterCODECHIPmoduleportand

activated,theinformationistransferredintotheQuidelTriageMeterPro’smemory.ACODECHIPmodule

typicallyneedstobe

installedonlyonceandremainsinthemetermemory.ACODECHIPmoduledoesnot

needtoremaininthemeterwhileperf ormingtests.



TherearefivetypesofCODECHIPmoduleswhichcanbedistinguishedbyshapeorcolor.



StandardCODECHIP



module



 ReagentTestCODECHIPmodule–includedineach boxoftestdevices;containscalibration,expirationdate

andotherdataaboutthedevicelot.(Colorvariesbytesttype.)

 QCSampleCODECHIPmodule–includedineachboxofQCSample;containsexpirationdateandother

data

abouttheQCSamplelotincludingacceptablerange.(White.)

 QCDeviceCODECHIPmodule–includedintheblackQCDevicebox(comeswiththeQuidelTriage

MeterPro);containsdataabouthowthemetershouldreaditsmatchingQCDevice.(Darkgray.) 

 Supervisor AccessCODECHIPmodule–included

witheachQuidelTriageMeterPro;containscodeto

activateSupervisorfunctions.(Lightgray.)



NOTE:TheQuidelTriageMeterProwillautomaticallyturnoffifleftunusedfor2hours,unless

programmedotherwisebythesupervisor.Optionalsettingsallowautomatedturnoffafter30minutes,

1hour,2hours,4hoursorNONE.

Page23of86



 SoftwareUpgradeCODECHIPmodule–providedwhenQuidelTriageMeterProsoftwareupgradesare

available;containsnewsoftwareforthemeter.



SetParameters

Purpose

TheSETPARAMETERSfunctionallowsthesupervisortoselectanumberofsettings.Accesstothesesettings

iscontrolledusingtheSupervisorCODECHIPmodule.



ListofProgrammableParameters

Asupervisorcansetthefollowingparameters:

Heading Parameters

IDSETTINGS NumberofCharactersinUserID,NumberofCharactersinPatient

ID,NumberofCharactersinAuxiliaryID,EnableorDisable

AuxiliaryID,NumberofCharactersinMiscTestID

DISPLAYSETTINGS Language,PrinterMode,AutoPowerͲOff,DisplayContrast,

PrinterContrast

COMMUNICATIONS BaudRate,EnableorDisableLIS,EnableorDisableAutoUpload,

EnableorDisablePatientResultApproval

CLOCK

Time,Date,andDisplayFormat

USERID

AddNewUserID,UpdateUserID,DeleteUserIDorUserIDList

RANGES

TestCutoffs

TESTSETTINGS

BlockAnalytes

QCPARAMETERS MinimumFrequencyforQCTests,NumberofControls,Number

ofStandardDeviations(QuantitativeTests)

BYPASS

DisableUserIDrequirement



SupervisorAccess

ASupervisorCODECHIPmoduleisshippedwitheachmeter.Installing

theCODECHIPmodulegivesthesupervisoraccesstotheSET

PARAMETERSandDELETERESULTSfunction.

Page24of86

ToinserttheSupervisorCODECHIPmoduleintotheQuidelTriageMeterPro,slidethechiplabeled"SPR"

intothemeter’sCODECHIPmoduleportasshowninthepicture.



HowtoSetParameters:BasicInstructions

Allinstructionsassume:

 Themeterison.

 Themeterscreenisdisplayingthemainmenu.

 TheSupervisorCODECHIPmoduleisinstalled.



1. SelectSETPARAMETERSusingthe



keys.

2. Pressthekey.

3. Youwillseealistofprogrammableparameters.



METERSETTINGS



CLOCK

USERID

RANGES

TESTSETTINGS

CPARAMETERS

BYPASS



SELECTWITHvOR^ANDPRESSENTER

ORPRESSEXI



TheSetParametersMenu



4. Usethe



keystoselecttheparameteryouwanttoprogram:

METERSETTINGS,CLOCK,USERID,RANGES,TESTSETTINGS,QCPARAMETERS,

orBYPASS.

5. Pressthekey.

6. Followthedirectionsforsettingtheselectedparameter(seethenextsection).



NOTE:Tosavechanges,presstheENTERkey.Tocancelchanges,presstheEXITkey.Wheneitherthe

ENTERortheEXITkeysarepressed,themeterperformstheappropriatefunctionandreturnstothe

previousmenu.

Page25of86



MeterSettings

Thismenuwillallowyoutosetbasicoperationalcriteriaforthemeter:language,

displaycontrast,maximumlengthoftheuser,patient, auxiliaryandmisc.ID's,

printermodeandautomaticpoweroff.



IDSettings

CharactersUserID

Thissettingwillsettheminimumandmaximumnumberofcharactersin

theUserID.



1. Fromalistofprogrammableparameters,chooseINSTRUMENTSETTINGSusingthe



keys.

2. Pressthekey.

3. Usethe



keystoselectIDSETTINGS.

4. Pressthekey.



5. Usethe



keystoselectthenumbertotherightofCHARACTERSUSERIDundertheMIN

column.



6. Usethe



keystochoosethesmallestnumberofcharactersthatwillappearintheUserID.The

minimumnumberofcharacterspossibleis1.



7. UsethekeytoselectthenumbertotherightofCHARACTERSUSERIDundertheMAXcolumn.

8. Usethe



keystochoosethelargestnumberofcharactersthatwillappearintheUserID.The

maximumnumberofcharacterspossibleis16.



9. Pressthekeytosavechanges.



CharactersPat.ID



ThissettingwillsettheminimumandmaximumnumberofcharactersinthePatientID.

1. Fromalistofprogrammableparameters,chooseINSTRUMENTSETTINGSusingthe



keys.

2. Pressthekey.

3. Usethe



keystoselectIDSETTINGS.

4. Pressthekey.

5. Usethe



keystoselectthenumbertotherightofCHARACTERSPAT.IDundertheMINcolumn.



6. Usethe



keystochoosethesmallestnumberofcharactersthatwillappearinthePatientID.

Theminimumnumberofcharacterspossibleis1.

7. UsethekeytoselectthenumbertotherightofCHARACTERSPAT.IDundertheMAXcolumn.

8. Usethe



keystochoosethelargestnumberofcharactersthatwillappearinthePatientID.The

maximumnumberofcharacterspossibleis20.

 MainMenu

 SetParameters

 MeterSettings

 IDSettings

 MainMenu

 SetParameters

 Meter Settings

 IDSettings

Page26of86

 MainMenu

 SetParameters

 MeterSettings

 IDSettings

9. Pressthekeytosavechanges.



CharactersAux.ID

ThissettingwillsettheminimumandmaximumnumberofcharactersintheAuxID.

IfthesettingofA

UX.IDENABLE/DISABLEisENABLED,anAuxiliaryIDismandatoryfor

eachpatienttest.



1. Fromalistofprogrammableparameters,chooseMETERSETTINGSusingthe



keys.



2. Pressthekey.

3. UsethekeystoselectIDSETTINGS

4. Pressthekey.

5. UsethekeystoselectthenumbertotherightofCHARACTERSAUX.IDundertheMIN

column.



6. Usethe keystochoosethesmallestnumberofcharactersthatwillappearinthe AuxiliaryID.

 Theminimumnumberofcharacterspossibleis1.

7. UsethekeytoselectthenumbertotherightofCHARACTERSAUX.IDundertheMAXcolumn.

8. Usethe keystochoosethelargestnumberofcharactersthatwillappearintheAuxiliaryID.

 Themaximumnumberofcharacterspo ssibleis12.

9. Pressthekeytosavechanges.



Aux.IDEnable/Disable

ThissettingwillturnonorturnofftheAuxiliaryIDfunction.TheAuxiliaryIDmaybe

usedforrecordingatestordernumber,physicianIDorotherspe cializedidentifying

information.



1. Fromalistofprogrammableparameters,chooseMETERSETTINGSusingthekeys.

2. Pressthekey.

3. UsethekeystoselectIDSETTINGS.

4. Pressthekey.

 Usethe



keystoselectthewordtotherightofAUX.IDENABLE/DISABLE.

 Usethe



keystochooseDISABLEDorENABLED.IfDISABLEDisselected,theAuxiliaryID

promptscreenswillneverappear.IfENABLEDisselected, anAuxiliaryIDismandatoryforeachpatient

test.



7. Pressthekeytosavechanges.



NOTE:

TheAuxiliaryIDis shownonly ontheNewResultdisplayorprintout.Itisnotvisibleinrecalled

results.Trackingmaybemanagedthroughtheoptionalsoftwarepackage,QuidelTriageCensus.

 MainMenu

 SetParameters

 MeterSettings

 IDSettings

Page27of86

CharactersMisc.ID

ThissettingwillsettheminimumandmaximumnumberofcharactersintheMisc.TestID.





Fromalistofprogrammableparameters,chooseINSTRUMENTSETTINGSusingthekeys.

2. Pressthekey.

3. UsethekeystoselectIDSETTINGS.

4. Pressthekey.



5. UsethekeystoselectthenumbertotherightofCHARACTERSMISC.IDundertheMin

column.



6. UsethekeystochoosethesmallestnumberofcharactersthatwillappearintheMISC.TEST

ID.Theminimumnumberofcharacterspossibleis1.



7. UsethekeytoselectthenumbertotherightofCHARACTERSMISC.IDundertheMAXcolumn.

8. UsethekeystochoosethelargestnumberofcharactersthatwillappearintheMISC.TESTID.

Themaximumnumberofcharacterspossibleis20.



9. Pressthekeytosavechanges.



DisplaySettings

Language

Thissettingwilldeterminewhichla nguagethemeterdisplaysandprints.



1. Fromalistofprogrammableparameters,chooseMETERSETTINGSusingthekeys.

2. Pressthekey.

3. UsethekeystoselectDISPLAYSETTINGS.

4. Pressthekey.

5. Usethekeystohighlightthenameto

therightofLANGUAGE.

6. Usethekeystochange thelanguageoftheQuidelTriageMeterP ro’sscreenandprintouts.

7. Pressthekeytosavechanges.



PrintMode

Thissettingwilldetermineifthemeterprintsautomaticallyoronlywhenrequested.



1. Fromalistofprogrammableparameters,

chooseMETERSETTINGSusingthekeys.

2. Pressthekey.

 MainMenu

 SetParameters

 Meter Settings

 DisplaySettings

Page28of86

3. UsethekeystoselectDISPLAYSETTINGS.

4. Pressthekey.

5. Usethekeystoselecthighlightthewo rdtotherightofPRINTMODE.

6. UsethekeystochooseAUTOMATICorMANUAL.IfAUTOMATICisselected,themeterwill

immediatelyprintouttheresults after 

eachtest(patient,QCorMiscTest).IfMANUALisselected,the

usermustusethebuttononthekeypadtoprintoutresults.

7. Pressthekeytosavechanges.



AutoPower–Off

Thissettingwilldeterminethelengthoftimebeforeaninactivemeter

willpoweroff.



1. Fromalistofprogrammableparameters,chooseMETERSETTINGSusingthekeys.

2. Pressthekey.

3. UsethekeystoselectDISPLAYSETTINGS.

4. Pressthekey.

5. Usethekeystoselectthevaluetothe right ofAuto PowerͲOff.

6. Usethekeystochoose

thedesiredtimersettingforthemetertopoweritselfoffwhennotin

use.Thechoicesare:1/2HOUR,1HOUR,2HOURS,4HOURS orNONE.IfNONEisselected,themeter

mustbemanuallyshutoffusingtheON/OFFkey.

7. Pressthekeytosavechanges.

.

DisplayContrast

Thissettingwilladjustthedisplaycontrast.

1. Fromalistofprogrammableparameters,chooseMETERSETTINGSusingthekeys.

2. Pressthekey.

3. UsethekeystoselectDISPLAYSETTINGS.

4. Pressthekey.

5. UsethekeystoselectthenumbertotherightofContrast.

6.

Usethekeystochange thecontrastofthemeter’sscreen.Therangeisfrom0–8(8beingthe

greatestcontrast).

7. Pressthekeytosavechanges.



NOTE:

Whenpoweredonlybybatteries,select1/2hourtoconservebatterylife.Certainscreens,whendisplayed,

willnotautomaticallypoweroff.TheNewResultsscreenisanexample.



 MainMenu

 SetParameters

 Meter Settings

 DisplaySettings

Page29of86



PrinterContrast

Thissettingwilladjusttheprintercontrastformeterswithaserialnumber

29901orgreater.



1. Fromalistofprogrammableparameters,chooseMETERSETTINGSusingthekeys.

2. Pressthekey.

3. UsethekeystoselectPRINTERCONTRAST.

4. Pressthekey.

5.

UsethekeystoselectthenumbertotherightofContrast.

6. Usethekeystochangethecontrastofthemeter’sscreen.Therangeisfrom0Ͳ8(8beingthe

greatestcontrast).

7. Pressthekeytosavechanges.



CommunicationSettings

PriortoactivatingtheLISfeature,obtainthemeter’sserialnumberlocated

underneaththemeterandcontactQuidel(RefertotheAssistancesection).

TheQuidelRepresentativewillprovideyouwithapasswordthat,whenentered,

willallowdatatobetransmitted.



BaudRate

1. 

1. Froma

listofprogrammableparameters,chooseMETERSETTINGSusingthekeys.

2. Pressthekey.

3. UsethekeystoselectCOMMSETTINGS.

4. Pressthekey.

5. UsethekeystoselectBAUDRATE.

6. Usethekeystochoose9600or38400.

7. Pressthekey.



PatientResult



Approval



Someinstitutionsmaywishforpatienttestresultstobeverifiedbytheuser

beforeprintingorsendingtotheLIS.Activationofthisfeaturedisplaystheresult,

thenrequirestheusertoacceptorrejecttheresultbeforetherecordisprinted

andsaved.Ifthetestisrejected,the

meterwillpermanentlyflagitasrejected

bytheuser.



1. Fromalistofprogrammableparameters,chooseMETERSETTINGSusingthe



keys.

2. Pressthekey.

 MainMenu

 SetParameters

 Meter Settings

 CommSettings

 MainMenu

 SetParameters

 Meter Settings

 DisplaySettings

 MainMenu

 SetParameters

 MeterSettings

 CommSettings

Page30of86

3. Usethe



keystoselectCOMMSETTINGS.

4. Pressthekey.

5. Usethe



keystoselectPAT.RESULTAPPROVAL.

6. Usethe



keystochooseDISABLEDorENABLED.

7. Pressthekey.

Whenenabled,afterapatient resultisavailableanddisplayed on the

meterscreen,theusermustacceptor

rejecttheresultbeforeprinting,uploadingorperforminganyothermeterfunctions.



ThemeterpromptstheusertoPRESS 1TOACCEPTOR0TOREJECT.Oncethetesthasbeenacceptedor

rejected,themeteroperatesnormally.



Ifthetesthasbeen

rejected,thedisplayandprintoutwillbe flaggedwithPAT.RESULTREJECTEDor

RESULTSREJECTEDBYUSER.Re calledresultswilldisplayanRbeforethepatientIDintherejectedrecord.



LISEnable

1. Fromalistofprogrammableparameters,chooseMETERSETTINGS

usingthe



keys.



2. Pressthekey.

3. Usethe



keystoselectCOMMSETTINGS.

4. Pressthekey.

5. Usethe



keystoselectLIS.

6. Usethe



keystochooseDISABLEDorENABLED.

7. Pressthekey.

8. IfDISABLEDwasselected,ascreenshowingaLISDISABLED

willappear.Press

thekey . 

9. IfENABLEDwasselected,ascreenshowingaENTERLISPASSWORD willappear.Enterthepassword

providedbytheQuidelRepresentative.Pressthekey.

10.AcknowledgetheLISENABLEDmessagebypressingthekey.



AutoUpload

(ThisfeatureisvisibleaftertheLIShas

beenenabled)

1. Fromalistofprogrammableparameters,chooseMETERSETTINGSusingthe



keys.

2. Pressthekey.

3. Usethe



keystoselectCOMMSETTINGS.

4. Pressthekey.

5. Usethe



keystoselectAUTOUPLOAD.

6. Usethe



keystochooseENABLED

orDISABLED.

7. Pressthekey.

 MainMenu

 SetParameters

 MeterSettings

 CommSettings

Page31of86



Clock

Theclockmenusetsthetimeanddateofthemeterandtheformatfordisplaying

both.Ifthemeterhaslostpower,thetimeanddatewillblinkontheMainMenu.



1. Fromthelistofprogrammableparameters,chooseCLOCKusingthe



keys.

2. Pressthekey.

3. Usethe



keystoselecttheHOUR:MINUTEarea.Usingthekeypad,typeinthecorrecttime.

Thenumbersyoutypewillappearfromtherightandmoveleftasyoucontinuetotype.



4. PresstomovetoAMorPM.Ifthe24HR.formathasbeenpreviouslyselected,theAMorPMwill

notbevisableandtheTIMEFORMATwillbehighlighted.Proceedtostep7below.



5. SelectAMorPMusing the



keys.

6. PresstomovetoTIMEFO RMAT .

7. Usethe



keystoselectAM/PMor24HR.Ifselecting24HR.,thepreviouslyenteredHOUR:

MINUTEwillchangetoa24Ͳhourformatand theAMorPMwilldisappear.

8. PresstomovetotheDATE.

9. Usingthekeypad,typeinthe6ͲdigitdateaccordingtotheDATEFORMATbelowit.

10. PresstomovetotheDATEFORMAT.

11. Usethe



keystoselectMMͲDDͲYY,DDͲMMͲYYorYYͲMMͲDD.ThepreviouslyenteredDAT E

changesastheDATE

FORMATchanges.

12. Presstosavechanges.



UserID

Upto600UserID'swith1–16charactersmaybeprogrammedintothemeter.

TheUserIDmayalternatelybeenteredusingtheexternalBarCodeScanner

(optional).



AnadditionalsecurityfeatureoftheUserIDisthepartialmaskingoftheIDondisplaysandprintouts.This

prevents

unauthorized individualsfromdetectingandusinganexistingUserID.WhentheSupervisorCODE

CHIPmoduleisinstalledinthemeter,thisfeatureisoverriddenandallUserIDcharactersaredisplayed.



NewUserID

1. Fromthelistofprogrammableparameters,chooseUSERIDusingthe



keys.

2. Pressthekey.

3. SelectNEWUSERIDusingthe



keys.

4. Pressthekey.

 MainMenu

 SetParameters

 UserID

 MainMenu

 SetParameters

 Clock

NOTE:

IfyouhaveselectedAM/PM,AMorPMappearsafterthetime,asappropriate.

Page32of86

5. TypeinaUserIDwithanumberofcharacterswithinMINCHARACTERS USERIDandMAXCHARACTERS

USERID.Tocorrect,presstocleartheentireID,orselecttheincorrectcharacterbyusingthe



keys.Thentypeinthecorrect ID. 

6. Pressthekey.

7.

Onthenextscreen,usethe



keystoselectanexpirationdatetotherightofUSERIDSTATUS:6

MONTHS,12MONTHS,VALIDorEXPIRED.

8. Pressthekeytosavechanges.



TheQuidelTriageMeterPr orecognizes0’sasauniquecharacter.Therefore,‘4341’will

berecognized

separatelyfrom‘04341’.



Usingthebarcodescanneroralphamode(shiftkey)willallow the QuidelTriageMeterProtoacceptalpha

charactersandthefollowingsymbols:#()*Ͳ./\



UpdateUserID

1. Fromthelistofprogrammableparameters,chooseUSERIDusingthe



keys.



2. Pressthekey.

3. SelectUPDATEUSERIDusingthe



keys.

4. Pressthekey.

5. TypeintheuserIDyouwanttoupdate.Tocorrect,presstocleartheentireID,or

selectthe

incorrectcharacterbyusingthe



keys.ThentypeinthecorrectID.

6. Pressthekey.

7. TheuserIDisdisplayedwiththeexpirationdate.Youcanchangetheexpirationdateto6MONTHS,12

MONTHS,EXPIREDorVALIDbyusingthe



keys.VALIDreconfirmsthe

previouslyselected

interval.

8. Pressthekeytosavechanges.



DeleteUserID

 Fromthelistofprogrammableparameters,chooseUSERIDusingthe



keys.

 Pressthekey.

 MainMenu

 SetParameters

 UserID

NOTE:

UserID9999999999(10Ͳ9’s)isadefaultsettingdisplayedwhentheUserIDBypassisonorwhena

testisrunwiththeSupervisorCODECHIPmoduleinstalled.

NOTE:

IfyoutypeinaUserIDthathasalreadybeenassigned,themessageonthescreenstates:

USER###ALREADYEXISTS.PressENTERtogobackandtypeinadifferentID

NOTE:

IfyoutypeinaUserIDthatdoesnotexist,themessageonthescreenstates:USERID###DOES

NOTEXIST.

Ifthishappens,press

ENTER

toreturntothepreviousscreenandcorrecttheID,orpresstheEXITkey.



Page33of86

 SelectDELETEUSERIDusingthekeys.

 Pressthekey.

 Type intheuserIDtobedeleted.Tocorrect,press tocleartheentireID,orselecttheincorrect

characterbyusingthekeys.ThentypeinthecorrectID.

 Pressthekey.Themessageonthescreenstates:USERID###WILLBEDELETED.

 Pressthekeytodelete.Amessageonthescreentel lsyouthattheIDhasbeendeleted:USERID

###DELETED.



UserIDList

1. Fromthelistofprogrammableparameters,chooseUSERIDusing

the



keys.

2. Pressthekey.

3. SelectUSERIDLISTusingthe



keys.

4. Pressthekey.



5. Alistisdisplayed.

6. Usethe



keystoselectthetypeofIDlistyouwant:USERID,FROMEXPIRATIONDATE,TILL

EXPIRATIONDATE.

 Fora listofallID's,selectUSERID.

 Fora singleID,selectUSERIDandtypeintheID.

Tocorrect,presstocleartheentireID,or

selecttheincorrectcharacterbyusing the



keys.ThentypeinthecorrectID.

 Fora range ofID's,entertheFRO M and/ortheTOdates.Thedatesareenteredbytypingthemonth

number,thedaynumberand

theyearnumberintheformatyouhavechosen.Thenumbersyou

typewillappearfromtherightandmoveleftasyoucontinuetotype.Tocorrect,pr ess 



toclear

theentiredate.Thentypeinthecorrectdate.

7. Pressthekey.

8. Toprintthelistyou

havechosen,press .



Ranges

Dependingonthepaneltype,therangeonthedisplayandprintoutwillbe

titledREFERENCERANGESorTHRESHOLDS.Thelowend,whenthetestdisplays

thresholds,issetto‘0’andisunchangeable. 



Someanalytesaredesignedforthreedistinctranges.Themeterdistinguishesbetweentworangeandthree

range

analytesinthesetupscreenbydifferentiatingthesymbolbetween theloweranduppervalues.



 Analyteswithadash–Tworanges.Thenormalrangeisanyvaluebetweenthetwonumbersdisplayed.

Dependingontheproduct,thenormalrangemaybeinclusiveorexclusiveoftheupper

number.Consult

NOTE



IfyoutypeinaUserIDthatdoesnotexist,themessageonthes creenstates:USERID###DOESNOT

EXIST.

Ifthishappens,press

ENTER

toreturntothepreviousscreenandcorrecttheID, orpresstheEXITkey.



 MainMenu

 SetParameters

 UserID

 MainMenu

 SetParameters

Page34of86

theproductpackageinsertorcontactQuidelforclarification.Thesevalueswillbeinreversevideoon

thepatientresults.

 Analyteswithacomma–Threerangespossible.Ifthelowernumberis0.0,themetertreatsthe

analyteashavingonlytworanges.If the lowernu mberisnot

0.0,thenormalrangeisanyvalueless

thanthelowernumber.Thefirstabnormalrangeisanyvaluebetweenthetwonumbersandisinclusive

ofthesenumbers.Thesevalueswillbeboxedonpatientresults.Thesecondabnormalrangeisanyvalue

greaterthantheuppernumber.These

valueswillbeinreversevideoonpatientresults.Consultthe

productpackageinsertorcontactQuidelforclarification.



1. Fromthelistofprogrammableparameters,chooseRANGESusingthe



keys.

2. Pressthekey.

3. Selectthetestpaneltypeusingthe



keys.

4. Selecttheanalyte

andlevelusingthe



keys.TheHIGHandLOWvalueforeachoftheanalytes

canbechangedusingthekeypadtotypeinthevalues.Tocorrect,presstocleartheentirenumber.

Thentypeinthecorrectnumber.

5. Pressthekeytosavechanges.



TestSettings

Incertaincases,thelabsupervisormaywishtocontro lwhichtestsareavailable

toberunatthetimeofpatienttesting.Theoptionsare:

1. ACTIVE(ACTIVONSCREEN):

Thetestisalwaysrunandcannotbedeselected.

2. INACTIVE(INACTONSCREEN):

Thetestisneverrunandisnotdisplayed.

3. USERINACTIVE(USRIONSCREEN):

Thetestcanbeselectedbytheuseratthetimeofrunningthetest.

4. USERACTIVE(USRAONSCREEN):

Thetestcanbedeselectedbytheuseratthetimeofrunningthetest



Iftheseoptionsarenotavailableforatest,themeterskipsoverthesettingasthesupervisorscrollsthrough

theoptions.Seepage45formoredetails.



1.

1. 

1.

1. 

1.

1. 

1.

1. 

1. Fromthelistofprogrammableparameters,chooseTESTSETTINGSusingthe



keys.

2. Pressthekey.

3. Selectthetestpaneltypeusingthe



keys.

4. Selecttheanalyteusingthe



keys.

5. Select

thedesiredmodeusingthe



keys.

 ACTIVE(ACTI VON

SCREEN)–Thetestwillrunoneverypatientspecimen.

 INACTIVE(INACTONSCREEN)–Thetestwillneverrunonapatientspecimenandisdroppedfrom

alldisplaysandprintouts.

 USERINACTIVE(USRIONSCREEN)

–Atthetimeofpatienttesting,theuserhastheabilitytoselect

thetest.

NOTE:

Thefieldwillbedisabledifthepanelsettingisfixed.Consultthespecificpanelpackageinsertto

determineifthesettingmaybechanged.

 MainMenu

 SetParameters

Page35of86

 USERACTIVE(USRAONSCREEN)–Atthetimeofpatienttesting,theuserhastheabilityto

deselectthetest.

6. Pressthekeytosavechanges.



QCTestsWithTestSettingsActivated

AnytestwhichtheSupervisorhassettoACTIVE,USERACTIVEorUSERINACTIVEwillrunontheQCSample

panel.Themeterwilldisplayandprintthetest’sQCsampleresultandupdatetheQCSampletimerforthe

test.IftheSupervisorhassetthetesttoINACTIVE,

thetestwillhavetheQCSampleturnedOFF.TheQC

Sampleresultwon’tshowforthattestandtheQCSampletimerwon’tbeupdatedforit.



IftheSupervisorchangesthetestfromINACTIVEtoACTIVE,toUSERACTIVEortoUSERINACTIVEthattest

maybeout

ofQCSampledate.Asalwaysforatestwithanexpir edQCSample,apassingQCSampletestwill

needtorunbeforeapatientsamplecanreportaresultforthattest.



QCParameters

TheQCParametersmenuprovidestheusertheoptionsfordeterminingwhatthe

maximumfrequencyisforrunningtheQCDeviceandQCSample,whether1or2

levelsofcontrolarerequiredfortheQCSample,andwhethertheallowedQC

SampleRangeofquantitativetestsis2or3

standarddeviations.



QCDeviceFrequency

TheQCDEVICEFREQUENCYsettingdeterminesthemaximumintervalbetweenQCDeviceteststhatauser

isallowedtorunpatienttests.Whentheintervalhaslapsed,allusersarelockedoutoftheRunTestmenu

untilaQCDevicehasbeensuccessfullyrun.

ItisrecommendedthattheQCDeviceberundailywhenperformingpatienttesting.

1. Fromthelistofprogrammableparameters,chooseQCPARAMETERSusingthe



keys.

2. Pressthekey.

3. Usethe



keystoselecttheinformationtotherightofQCDEVICEFREQ.

4. Usingthe



keys,selectoneoftheseoptions:NONE,8HOURS,DAILY,WEEKLY,MONTHLY.

5. Pressthekeytosavechanges.



QCSampleFrequency

TheQCSAMPLEFREQUENCYsettingdeterminesthemaximumintervalbetweenQCSampleteststhatauser

isallowedtorunpatienttestsonapar ticulardevicelotnumber.Whentheintervalhaslapsed,allusersare

lockedoutoftheRUNPAT IENT TESTmenuuntilaQC

Samplehasbeensuccess fullyrun.Toviewwhena

particulardevicelot’sQCSamplewillexpire,usetheRECALLREAGENTLOTS–QCfeature.



ItisrecommendedthattheQCSampleberunwitheverynewshipment,newlotormonthly,whicheveris

lesswhenperformingpatient testing.



NOTE:

Whentheanalyteisdeselected,thevalueis notcalculatednorstored

 MainMenu

 SetParameters

 QCParameters

Page36of86

1. Fromthelistofprogrammableparameters,chooseQCPARAMETERSusingthe



keys.

2.

Pressthekey.

3. Usethe



keystoselecttheinformationtotherightofQCSAMPLEFREQ.

4. Usingthe



keys,selectoneoftheseoptions:NONE,8HOURS,DAILY,WEEKLY,MONTHLY.

5. Pressthekeytosavechanges.



NumberofControls

 Fromthelistofprogrammableparameters,chooseQCPARAMETERS

usingthe



keys.



2.

Pressthekey.

3. UsethekeystoselecttheinformationtotherightofNumberofControls.

4. Usingthekeys,selectoneoftheseoptions:1or2.

5. Pressthekeytosavechanges.

NumberofControlStandardDeviationsforQuantitativeTests

1. Fromthelistofprogrammableparameters,chooseQCPARAMETERS

usingthe



keys.

2. Pressthekey.

3. Usethe



keystoselecttheinformationtotherightofNUMQUANTSTDDEVS.

4. Usingthe



keys,selectoneoftheseoptions:2or3.

5. Pressthekeytosavechanges.

BypassUserID

Thisfunctionallowsthesupervisortose lectively bypasstherequirementtoenter

auserIDbeforeperforminganytest.



1. Fromthelistofprogrammableparameters,chooseBYPASSusingthe



keys.

2. Pressthekey.

3. SelectUSERIDusingthe



keys.



4. Usethe



keystoselectfromtwooptions:ONorOFF.

5. Pressthekey.



 MainMenu

 SetParameters

 QCParameters

NOTE:

IfthebypassisON,theUserIDrequirementis disabled andthereforenotrequired.Whenthe

bypassisOFF,theUserIDrequirementoperatesasnormalandisrequired.



 MainMenu

 SetParameters

 Bypass

Page37of86

InstallCodeChip

Purpose

TheQuidelTriageMeterPr owillprompt theusertoinstallaCODECHIPmodule whenrequired.However,

theINSTALLCODECHIPfunctionmaybeusedasanalternatemethodtotransferinformationfromaCODE

CHIPmoduleintothemeter’smemory.ThemeterwilldirecttheusertoinstallaCODE

CHIPmoduleifitis

attemptingtorunatestanddoesnothavethedatainitsmemory.



TypesofCODECHIPmodules

TherearefivetypesofCODECHIPmodules



 ReagentCODECHIPmodule–includedineachboxoftest

devices.Lotnumberbeginswitha W.



 QC SampleCODECHIPmodule–includedineachboxof

controls.LotnumberbeginswithaC.



 QC Device

CODECHIPmodule–includedintheblackQC

Devicebox(comeswiththeQuidelTriageMeterPro)andis

labeledwiththeserialnumberoftheQCDevice.

 SupervisorAccessCODECHIPmodule–includedwitheach

QuidelTriageMeterPro.LotNumberbeginswithSPR.



 SoftwareUpgradeCODE

CHIPmodule–sentseparately

whenQuidelTriageMeterProsoftwareupgradesare

available.



CAUTION:RunningtestswiththeSupervisorCODECHIPmoduleinstalleddisablesallQC

Lockouts.RemovetheSupervisorCODECHIPmodulepriortorunningtests.



InstallationofReagent,QCSampleorQCDeviceCODECHIPModules

InstallCodeChip



1. FromtheMainMenuselectINSTALLCODECHIPusingthe



keys.

2. Pressthekey.

 MainMenu

Page38of86

3. SlidetheCODECHIPmoduleintotheCODECHIPmodulePortintheQuidelTriageMeterPro,asshownin

thepicture.



4. Pressthekey.

5. ThemeterwilldisplayaconfirmationmessagethattheinformationwasinstalledintotheQuidelTriage

MeterPro’smemory.

6. Presstoreturntoacknowledgethemessage.

7. RemovetheCODECHIPmodulefromtheCODECHIPmodulePort.

8. PlacetheCODECHIPmodulebackinto

itsoriginalcontainerforstorage.

INSTALLATIONOFSUPERVISORCODECHIPMODULE

TheSupervisorCODECHIPmoduleneedsonlytobeinsertedintotheCODECHIPmodulePorttoactivatethe

supervisorfunctions.ThisisanautomaticfunctionandstandardCODECHIPmoduleinstallationisnot

necessary.



Page39of86

Operation

AccesstotheQuidelTriageMeterPro

Function Use Restrictedto

RUNTEST PatientTesting OperatorswithvalidUserID's*

QualityControlTesting OperatorswithvalidUserID's*

Misc.TestTesting OperatorswithvalidUserID's*

RECALLRESULTS LastRecord Iflasttestrunisapatientsample:

OperatorswithvalidUserID's*

Otherwise:Norestriction

PatientTestResults OperatorswithvalidUserID's*

QualityControlResults NoRestriction

Misc.TestResults NoRestriction

INSTALLCODECHIPS TypesofCODECHIP

modules

IfCODECHIPmoduleissoftware

upgrade:

Supervisor

InstallationProcedure Otherwise:Norestriction

SETPARAMETERS AccessControl Supervisor

ProgrammableSettings Supervisor

DELETERESULTS PatientTestResults Supervisor

*UnlessUserIDisbypassedortheSupervisorCODECHIPmoduleisinstalled.

 IMPORTANT:Thelasttwofunctions,SETPARAMETERS,andDELETERESULTS,appearonthemain

menuonlywhentheSupervisorCODECHIPmoduleisinsertedintotheCODECHIPmodulePort.The

SupervisorCODECHIPmoduleshouldberemovedfromthemeterduringroutinepatient,quality

control,andMisc.testing.



RunTest

Purpose

RunTestisusedfortheanalysisofatest.



Options

TheRuntestfunctionallowsyoutotest:

 QCDevice

NOTE:Accesstovariouspartsofthesoftwareisuser(institution)defined.

Page40of86

 QC Sample

 PatientSample 

 Misc.TestSample

Inordertorunapatientsample,themeterrequires:



1. AvalidUserIDhasbeenentered(unless thisfeatureisbypassedoraSupervisorCODECHIPmoduleis

installed).Seepage31.

2. AQCDevicehaspassedwithinthespecifiedtimeperiod.Seepage41.

3. AQCSa mpleforthetestdevicelothaspassedwithinthe

specifiedtimeperiod.Seepage 42.



Ifanyoftheseconditionsdonotexist,themeterwillnotcontinueandwill prompttheusertoperformthe

requiredsteps.



 IMPORTANT:

TheQuidelTriageMeterProwillalerttheuserifQChasnotbeenperformedforthe

devicelotbeingtested.



QCDevice

TheQCDeviceshouldberunoneachdayofpatienttesting.



ToruntheQCDevicetest:

1. PressthekeytopowertheQuidelTriageMeterProon.

2.

SelectRUNTESTusingthe keys.



3. Pressthekey.

4. Typeinyouridentification(UserID).Tocorrect,pressthekeytocleartheentireID,orselectthe

incorrectcharacterbyusingthekeys.ThentypeinthecorrectID.



8:23AM01•20•18



RUNTEST



RECALLRESULTS



INSTALLNEWCODECHIP



SELECTWITHvOR^ANDPRESSENTER

PRESSEXITTOEJECTDEVICE

TheMainMenu

NOTE:

TheSupervisorCODECHIPmoduleprovidesaccesstofunctionsthatmayoverridetheseLockouts.

NOTE:

IftheQuidelTriageMeterPro’sinternalqualitycontrol(QC)resultsareunacceptable,exclamation

points(!)willbedisplayedonthescreenintheplaceofthepatientresults.Toobtainresultsrepeatthe

testusinganewdevice.

NOTE:

IftheUserIDbypa ss ison,themeterwillnotaskyoutoenteraUserID.

 MainMenu

 Run Test

Page41of86

5. Pressthekey.

6. SelectQCDeviceusingthekeys.



“EXP”indicatesthatthe

QCDevicereͲtest

frequencyhasexpired.

PATIENTSAMPLE 

QCDEVICE  EXP

QCSAMPLE  EXP

MISC.TEST



SELECTWITHvOR^ANDPRESSENTER



PRESSEXITTOEJECTDEVICE



MenuscreenasitlookswhenoperatorselectsQCDevice.

 Pressthekey.



8. GentlyinserttheQCDeviceintotheQuidelTriageMeterPrountilyoufeeltheQCDevicecatchonthe

pinandhearanaudible‘click.’



 Pressthekey.



10.TheQuidelTriageMeterPropullsintheQCDeviceandscansit.Thetest

devicemaypartiallymoveinandoutofthemeterseveraltimes.

11.Whenthetestiscomplete,themeterwillbeep,ejectthedeviceanddisplaytheresultsonthe

meter’sscreen.

12.Press

thekeytomakeaprintedcopyoftheresults.

13.RemovetheQCDevicefromtheMeterandplaceintheQCDeviceBox.DONOTDISCARDTHE

QCDEVICE.

IMPORTANT:Importantinstructionsforalltests:

a. GentlyinsertthetestdeviceintotheQuidelTriageMeterPrountilyoufeelthedevicecatchonthe

pin.Youwillhearanaudible‘click’thattellsyouthetestdevicehasbeeninsertedproperly.

b. Pressthekeytostartthetest.

c.

TheQuidelTriageMeterPropullsinthetestdeviceandscansit.

d. Whenthetestiscomplete,themeterwillbeepanddisplaytheresultsonthemeter’sscreen.

e. Pressthekeytomakeaprintedcopyoftheresults.



CAUTION:Afterthetestdevicehasbeeninserted,donotpushthedeviceinfurtherorattempt

topullitout.ThedevicemaybeejectedbyreturningtotheMainMenuandpressingtheEXIT

key.

NOTE:ThemeterwillprompttheusertoinstalltheQCDeviceCODECHIPmoduleiftheQCDevicehasnot

beenrunbefore.

Page42of86



IMPORTANT:

ImportantInstructionsforQCDevicetests:

 Dust,lint,fibersandothersmallparticlesmayinterferewiththeQCDevice.K eeptheQCDevicefreeof

contaminants.

 TheQCDeviceislightͲsensitiveandshouldbestoredinitsblackopaquecasewhennotinuse.

 Ifthe

QCDevicetestsfail,wipetheQCDevicecleanwithalintfreeclothtoremoveanyoils,dust,

fibers,orfingerprints.DonotapplyanyliquidtotheQCDevice.Aftercleaningthedevice,repeatthe

QCDevicetest.

 IftheQCDevicetestfailsafteryouhavecleaned

thedevice,contactQuidel.

QCSample

ToruntheQualityControl sample:



1. PressthekeytopowertheQuidelTriageMeterProon.

2. SelectRUNTESTusingthe



keys.



8:23AM01•20•18



RUNTEST



RECALLRESULTS

INSTALLNEWCODECHIP



SELECTWITHvOR^ANDPRESSENTER

PRESSEXITTOEJECTDEVICE

TheMainMenu



3. Pressthekey.

4. Typeinyouridentification(UserID).Tocorrect,pressthekeytocleartheentireID,orselectthe

incorrectcharacterbyusingthe



keys.ThentypeinthecorrectID.



5. Pressthekey.

6. SelectQCSampleusingthe



keys.



PATIENTSAMPLE

QCDEVICE

QCSAMPLE



MISC.TEST



SELECTWITHvOR^ANDPRESSENTER

ORPRESSEXIT TOEJECTDEVICE



MenuscreenasitlookswhenoperatorselectsQCSample.

NOTE:

IftheUserIDbypa ss isON,themeterwillnotaskyoutoenteraUserID.

 MainMenu

 Run Test

Page43of86

7. Presstheke y.

8. EntertheQClotnumberfromthelabelonthesideofthebottlevialcontaining theQCSample.



9. Tocorrect,pressthe keytocleartheentirenumber.

Thentypeinthecorrectnumber.

10.Pressthekey.

11.Performthetestaccordingtotheinstructionsprovided

inthepackageoftestdevicesyouareusing.



IMPORTANT:Importantinstructionsforalltests:

a. GentlyinsertthetestdeviceintotheQuidelTriageMeterPrountilyoufeelthedevicecatchonthe

pin.Youwillhearanaudible‘click’thattellsyouthetestdevicehasbeeninsertedproperly.

b. Pressthe keytostartthetest.

c.

TheQuidelTriageMeterPropullsinthetestdeviceandscansit.

d. Whenthetestiscomplete,themeterwillbeepanddisplaytheresultsonthemeter’sscreen.

e. Pressthe keytomakeaprintedcopyoftheresults.

CAUTION:Afterthetestdevicehasbeeninserted,donotpushthedeviceinfurtherorattempt

topullitout.ThedevicemaybeejectedbyreturningtotheMainMenuandpressingEXIT.



12.Repeatstepsforeachqualitycontrolsample.

IMPORTANT:ImportantinstructionsforQCSampleTests

D Ifthetestdevice’sinternalqualitycontrol(QC)resultsareunacceptable,theresultsforthe

affectedanalyte(s)willnotappearonthescreen(insteadwillbeflaggedwitha!symbol).

b. IfanyoftheQCSampleresultsareoutofrange,theresultsforthatparticularanalytewill

bein

reversevideo(lighttextonadarkbackgr ound).



c. Apanelwithmultipleanalyteswillstillbeabletoreportpatientresultsonthoseanalyteswhich

passedQC.AnanalytethatfailedQCwillnotbereportedonpatienttests(insteadwillbeflagged

witha#symbol).

NOTE:OnlyenterthefourͲdigitnumericvalueoftheQClotnumber.Donotentertheprecedingalpha

character.

NOTE:IfyouenteraQClotnumberforwhichthereisnodataintheQuidelTriageMeterPro’smemory,you

willseeamessageonthemeter’sscreen:NOQCSampledatainmemory.

Tocorrectthis:InstalltheQCSampleCODECHIP(seepictureonpage37).

Press

ENTERtocontinue.

Page44of86

d. Ifanindividualanalyteisoutsidethespecifiedrange,theQuidelTriageMeterProallowstheusertorerunonlythefailed

analyteonthenextQCSampleTest.Whenallanalyteshavepassed,theQCSampletimerissettothedateofthefirst

passinganalyte.



PatientSample

1. PressthekeytopowertheQuidelTriageMeterProon.

2. SelectRUNTESTusingthekeys.



8:23AM01•20•18



RUNTEST



RECALLRESULTS

INSTALLNEWCODECHIP



SELECTWITHvOR^ANDPRESSENTER

PRESSEXITTOEJECTDEVICE

3. Pressthekey.

4. Typeorscaninyouridentification(UserID).Tocorrect,presstocleartheentireID,orselectthe

incorrectcharacterbyusingthe



keys.ThentypeinthecorrectID.



5. Pressthekey.

6. SelectPATIENTSAMPLEusingthekeys.



PATIENTSAMPLE



QCDEVICE



QCSAMPLE



MISC.TEST



SELECTWITHvOR^ANDPRESSENTER

ORPRESSEXIT TOEJECTDEVICE



7. Pressthekey.

8. Typeorscanthepatient’sidentification(PatientID).Tocorrect,presstocleartheentireID,or

selecttheincorrectcharacterusingthe



keys.ThentypeinthecorrectID.

9. Pressthekey.

 MainMenu

 Run Test

NOTE

:IftheUserIDbypassisON,themeterwillnotaskyoutoenteraUserID.

NOTE

:IftheBarCodeScannerisbeingused,simplypointthescanneratthebarcode,press thebuttonon

thescannerhandleandwa itforthebeep.TheIDwillappearonthedisplay

Page45of86



PatientSample

10.Iftheinformationis correct,pressthekeytoconfirmthePatientID.

Iftheinformationisincorrect:



 SelectCORRECTPATIENTIDusingthe



keys.

 Presstheke y.

 PressthekeytocleartheentireID,orselecttheincorrectcharacterusingthe



keys.



ThentypeinthecorrectID.

 Presstheke y.

11.IftheAUXILIARYIDfeatureisactivated,typeorscanintheID.Tocorrect,pressthekeytoclearthe

entireID,orselecttheincorrectcharacterusingthe



keys.Thentypein thecorrectID.

12.Press

thekey.

13.Preparethetestsampleandperformthetestinaccordancetotheinstructions providedinthepackage

oftestdevicesyouareusing.

14.Ifthetestingfacilityhasauthorizedananalytetobeselectedordeselectedatthetimeofrunninga

patienttest,theuser

willbepromptedtoselectdesiredanalytesordeselectundesiredanalytes.After

thetestdevicehasbeenpulledintothemeter,themeterwilldisplayamessagesimilartothefollowing: 



SELECTTESTS

CARDIAC



CKMB

MYO

TNI



PRESS^TOPAUSEOR0 Ͳ9FORTEST

PRESSENTERTOCONTINUEOREXI



Acheckmarkindicatestestswhichareselected.Example:TNI

Theabsenceofacheckmarkindicateswhichtestshavenotbeenselected.Example:MYO



Anumbertotheleftofthetestindicatestestswhichcanbeselectedordeselected.

 Example:2MYOindicatesthat

MYOiscurrentlynots elected,butcanbeselectedbypressing2onthe

numerickeypadtodisplay2MYO.

 Example:3TNIindicatesthatTNIiscurrentlyselected,butcanbedeselectedbypressing 3 onthe

numerickeypadtodisplay3TNI.

 Pressingthenumber

againtogglesthetestbetweenselectanddeselect.



Nonumbertotheleftofthetestindicatestestswhichcannotbealtered.

 ExampleCKMBindicatesthatCKMBisalwaysselected,and cannotbedeselected.

f Pressthekey.

f Iftheinformationiscorrect,pressthekeyto

continue.

 MainMenu

 Run Test

NOTE

:Atleastoneanalytemustbeselectedinordertocontinuetesting.

Page46of86

f Iftheinformationisincorrect,selectCORRECTTESTusingthe



keysandpressthekey

toreturntothelistsoftests.

IMPORTANT:

Importantinstructionsforalltests:

a. GentlyinsertthetestdeviceintotheQuidelTriageMeteruntilyoufeelthedevicecatchonthe

pin.Youwillhearanaudible‘click’thattellsyouthetestdevi cehasbeeninsertedproperly.

b. Pressthekeytostartthetest.

c. The

QuidelTriageMeterPropullsinthetestdeviceandscansit.

d. Whenthetestiscomplete,themeterwillbeepanddisplaytheresultsonthemeter’sscreen.

e. Pressthe keytomakeaprintedcopyoftheresults.



CAUTION

Afterthetestdevicehasbeeninserted,donotpushthedeviceinfurtherorattempt

topullitout.ThedevicemaybeejectedbyreturningtotheMainMenuandpressingEXIT.



IMPORTANT:Importantinstructionsforpatienttests:

a. Ifthetestdevice’sInternalQualityControl(QC)resultsareunacceptable,theresultsforthe

affectedanalyte(s)willnotappearonthescreen(insteadwillbeflaggedwitha!symbol).

b. IfanyoftheQCSampleresultsforthelotbeingtestedwere

outofrange,theresultsforthat

particularanalytewillnotappearonthescreen(insteadwillbeflaggedwitha#symbol).



PAT.ID89547326





PAT.ID89547326



  

BNP 15 pg/mL BNP 650 pg/mL



    

  

PAT.RESULTABNORMAL



  

PRESS1TOACCEPTOR0TOREJECT PRESS1TOACCEPTOR0TOREJECT

Screendisplayingpatientsresult

belowthecutofflevelandacceptor

rejectinstructions.

Screendisplayingpatientsresultabovethe

cutofflevels.



NOTE:IfnokeyispressedontheSELECTTESTSscreen,themeterwaits30secondsthenproceeds

usingonlytheselecteddefaulttests.Then,ifnokeyispressedontheCONFIRMATIONSCREEN,the

testproceedsafterwaiting30seconds.

Page47of86

Misc.TestSample

1. PressthekeytopowertheQuidelTriageMeterProon.



2. SelectRUNTESTusingthe



keys.



8:23AM01•20•18



RUNTEST



RECALLRESULTS

INSTALLNEWCODE CHIP



SELECTWITHvOR^ANDPRESSENTER

PRESSEXITTOEJECTDEVICE

3. Pressthekey.

4. Typeorscaninyouridentification(UserID).Tocorrect,presstocleartheentireID,orselectthe

incorrectcharacterbyusingthe



keys.ThentypeinthecorrectID.

5. Pressthekey.

6. SelectMISC.TEST

usingthe



keys.



PATIENTSAMPLE



QCDEVICE

QCSAMPLE



MISCTEST



SELECTWITHvOR^ANDPRESSENTER

PRESSEXITTOEJECTDEVICE



7. Pressthekey.

8. TypeorscantheMisc.Testidentification(Misc.TestID).Tocorrect,presstocleartheentireID,or

selecttheincorrectcharacterusingthe



keys.ThentypeinthecorrectID.

9. Pressthekey.

10.Iftheinformationis correct,pressthekey

toconfirmtheMisc.TestID.

Iftheinformationisincorrect:

 SelectCORRECTMISC.TESTIDusingthekeys.

 Pressthekey.

 MainMenu

 Run Test

NOTE

:IftheUserIDbypassisON,themeterwillnotaskyoutoenteraUserID.

NOTE

:IftheBarCodeScannerisbeingused,simplypointthescanneratthebarcode,pressthebutton

onthescannerhandleandwaitforthebeep.TheIDwillappearonthedisplay.

Page48of86

 PressthekeytocleartheentireID,orselecttheincorrectcharacterusingthekeys.

ThentypeinthecorrectID.

 Pressthekey.



11.Preparethetestsampleandperformthetestinaccordancetotheinstructions

providedinthepackageoftestdevicesyouareusing.



IMPORTANT:



Importantinstructionsforalltests:

a. GentlyinsertthetestdeviceintotheQuidelTriageMeteruntilyoufeelthedevicecatchonthepin.

Youwillhearanaudible‘click’thattellsyouthetestdevicehasbeeninserted properly.

b. Pressthekeytostartthetest.

c. The

QuidelTriageMeterPropullsinthetestdeviceandscansit.

d. Whenthetestiscomplete,themeterwillbeepanddisplaytheresultsonthemeter’sscreen.

e. Pressthe keytomakeaprintedcopyoftheresults.



CAUTION

Afterthetestdevicehasbeeninserted,donotpushthedeviceinfurtherorattempt

topullitout.ThedevicemaybeejectedbyreturningtotheMainMenuandpressingEXIT.



IMPORTANT:Importantinstructionsformisc.tests:

a. Ifthetestdevice’sInternalQualityControl(QC)resultsareunacceptable,theresultsforthe

affectedanalyte(s)willnotappearonthescreen(insteadwillbeflaggedwitha!symbol).



Page49of86

RecallResults

Purpose

RecallResultsisusedtoretrieveresultsstoredintheQuidelTriageMeterPro’smemory.



Function

TheRecallResultsfunctioncanretrievetheseresults:

 LastRecord

 PatientResults

f PatientID

f PanelType

f TestDeviceLotNumber(L/N)

f UserID

f FromDate

f TillDate



 QCResul ts 

f QCSampleResults

f QCDeviceResults

f ReagentLots–

QC

f ArchiveLastTest

 Misc.TestResults 

 PrintallResults

f PatientResults

f QCSampleResults

f QCDeviceResults

f Misc.TestResults

 UploadResultstoLIS



IMPORTANT:

TosafeguardtheUserIDLockout,displayedandprintedUserID'sarepartially

masked.TheSupervisorCODECHIPmo duleisrequiredtobeinstalledtoviewthefullUser ID.



LastRecord

Purpose:

LastRecordisusedtoretrievethetestresultsforthelasttestrun.

Toretrievethelastrecord:

1. PressthekeytopowertheQuidelTriageMeterProon.

2. FromtheMAINMENUselect RECALLRESULTSusingthe



keys.

3. Pressthekey.

4. SelectLASTRECORD

usingthe



keys.

5. Pressthekey.

6. Ifthelasttestrunisapatientr esult,typeorscaninyouridentification(UserID).Tocorrect,press

tocleartheentireID,orselecttheincor rectcharacterbyusingthe



keys.Thentypeinthe

correctID.Press

thekey. 

7. Theresultsfromthelasttestrunappearonthescreen.

8. Usethe



keystoviewtheentirerecord.

9. Pressthekeytomakeaprintedcopy.

 MainMenu

 RecallResults

NOTE

:IftheUserIDbypassisON, themeterwillnotaskyoutoenteraUserID

NOTE

:Ifaresultwasrejectedbytheuser,an“R”will appearnexttotherecalledresult.

Page50of86



PatientResults

Options:

Patientresultscanberetrievedbasedonavarietyofcriteria:

 PatientID

 TestDeviceLotNumber(L/N)

 UserID

 FromDate 

 TillDate



PatientID

ToretrieveresultsbasedonthepatientID:

1. PressthekeytopowertheQuidelTriageMeterProon.

2. FromtheMAINMENUselect RECALLRESULTSusingthe



keys.

3. Pressthekey.

4. SelectPATIENTRESULTSusingthe



keys.

5. Pressthekey.

6. Typeorscan

inyouridentification(UserID).Tocorrect,presstocleartheentireID,orselectthe

incorrectcharacterbyusingthe



keys.ThentypeinthecorrectID.

7. Pressthekey.

8. SelectPANELTYPEusingthe



keys.

9. Usethe



keystoselectthedesired

panel.

10. Choosetheres u ltsyouwanttosee:

 Ifyouwanttoseeallpatientresults,pressthekey.Allthepa tientresultsintheQuidelTriage

MeterPro’smemoryfortheselectedpanelwillbedisplayed.

 Forindividual patientresults:

a. SelectPatientIDusingthe



keys.



b. TypeorscaninthepatientID.Tocorrect,pressthekeytocleartheentireID,orselectthe

incorrectcharacterbyusingthe



keys.ThentypeinthecorrectID.

c. ToselectapatientID withalphacharacters,usethekeytoenteralphacharacters.

d. Pressthekey.AllresultsoftherequestedpatientIDfortheselectedpanelwillbe

displayed.

11. Usethe



keystoviewtheentirerecord.

12.Pressthekeytomakeaprintedcopy.

13.PressthekeytouploadtheselectedresultstoLIS.

 MainMenu

 RecallResults

 MainMenu

 RecallResults

 Patient Results 

NOTE

:IftheUserIDbypassisON, themeterwillnotaskyoutoenteraUserID

NOTE

:Youmaychoosemorethanoneoftheoptionsforrecallingresultsinordertodefinemoreprecisely

theinformationyouwanttorecallfromtheQuidelTriageMeterPro’smemory.Whenyouchoosemultiple

options,firstinputvaluesinallthecategoriesyouhavechosen.ThenpresstheENTERkey.



Page51of86



TestDeviceLotNum b er(L/N)

Toretrieveresultsbasedonthelotnumberofthetestdevicesused:



1. PressthekeytopowertheQuidelTriageMeterProon.

2. FromtheMAINMENUselectRECALLRESULTSusingthe



keys.

3. Pressthekey.

4. SelectPATIENTRESULTSusingthe



keys.

5.

Pressthekey.

6. Typeorscaninyouridentification(UserID).Tocorrect,presstocleartheentireID,orselectthe

incorrectcharacterbyusingthe



keys.ThentypeinthecorrectID.

7. Pressthekey.

8. SelectPANELTYPEusingthe



keys.

9. Usethe



keystoselectthedesiredpanel.

10.SelectDEVICEL/Nusingthe



keys.

11.Todisplayallresults fortheselectedpanel,pressthekey.

12.Todisplayresultsspecifictoonelot,typeinthelotnumberofthetestdevice.Tocorrect,pressthe

keyto

cleartheentirenumber.Thentypeinthecorrectnumber.



13.Presstheke y.

14.Allresultsfromtestsrunontherequestedlotnumberfortheselectedpanelaredisplayed.

15.Usethe



keystoviewtheentirerecord.

16.Pressthekeytomakeaprintedcopy.

17.PressthekeytouploadtheselectedresultstoLIS.



 MainMenu

 RecallResults

 Patient Results 

NOTE

:IftheUserIDbypassisON, themeterwillnotaskyoutoenteraUserID.

NOTE

:OnlyenterthefiveͲdigitnumericvalueofthelotnumber.

Page52of86

UserID

ToretrieveresultsfromtestsrunontheQuidelTriageMeterProstartingwith

theuseryouselect:



1. PressthekeytopowertheQuidelTriageMeterProon.

2. FromtheMAINMENUselect RECALLRESULTSusingthe



keys.

3. Pressthekey.

4. SelectPATIENTRESULTSusingthe



keys.

5. Pressthekey.

6. Typeorscaninyouridentification(UserID).Tocorrect,presstocleartheentireID,orselectthe

incorrectcharacterbyusingthe



keys.ThentypeinthecorrectID.

7. Pressthekey.

8. Select

3$1(/7<3(usingthe



keys.

9. Usethe



keystoselectthedesiredpanel.

10. Select

86(5,'usingthe



keys.

11. Todisplayallresultsfortheselectedpanel,pressthekey. 

12. TodisplayresultsspecifictooneUserID,typeintheUserID.Tocorrect,presstocleartheentireID,

orselecttheincorrectcharacterbyusingthekeys.Thentypein

thecorrectID.



13. Pressthekey.

14. Allresultsfromtestsrunbytherequesteduserfortheselected panelaredisplayed.

15. Usethe



keystoviewtheentirerecord.

16. Pressthekeytomakeaprintedcopy.

17. Pressthekeytouploadtheselected

resultstoLIS.



FromDate

ToretrieveresultsfromtestsrunontheQuidelTriageMeterProstartingwith

adateyouselect:



1. PressthekeytopowertheQuidelTriageMeterProon.

2. FromtheMAINMENUselect RECALLRESULTSusingthe



keys.

3. Pressthekey.

 MainMenu

 RecallResults

 Patient Results 

NOTE

:IftheUserIDbypassisON, themeterwillnotaskyoutoenteraUserID

 MainMenu

 RecallResults

 Patient Results 

Page53of86

4. SelectPATIENTRESULTSusingthe



keys.

5. Pressthekey.

6. Typeorscaninyouridentification(UserID).Tocorrect,presstocleartheentireID,orselectthe

incorrectcharacterbyusingthe



keys.ThentypeinthecorrectID.



7. Pressthekey.

8.

SelectPANELTYPEusingthe



keys.

9. Usethe



keystoselectthedesiredpanel.

10. SelectFROMDATEusingthe



keys.

11. Todisplayallresultsfortheselectedpanel,pressthekey. 

12. Todisplayresultsspecifictoonedate,typeinthedate.Tocorre ct,

pressthekeytoclear theentire

number.Thentypeinthecorrectnumber.

13. Pressthekey.

14. Allresultsfromtestsrunfromthedateselectedfortheselectedpanelaredisplayed.

15. Usethe



keystoviewtheentirerecord.

16. Pressthekeytomake

aprintedcopy.

17. PressthekeytouploadtheselectedresultstoLIS.



TillDate

ToretrieveresultsfromtestsrunontheQuidelTriageMeterProbeforeandincluding

adateyouselect:



1. PressthekeytopowertheQuidelTriageMeterProon.

2. FromtheMAINMENUselect RECALLRESULTSusingthe



keys.

3. Pressthekey.

4. SelectPATIENTRESULTSusing

the



keys.

5. Pressthekey.

6. Typeorscaninyouridentification(UserID).Tocorrect,presstocleartheentireID,orselectthe

incorrectcharacterbyusingthe



keys.ThentypeinthecorrectID.



7. Pressthekey.

NOTE

:IftheUserIDbypassisON, themeterwillnotaskyoutoenteraUserID.

 MainMenu

 RecallResults

 Patient Results 

NOTE

:IftheUserIDbypassisON, themeterwillnotaskyoutoenteraUserID

Page54of86

8. Select

3$1(/7<3(usingthe



keys.

9. Usethe



keystoselectthedesiredpanel.

10. Select

7,//'$7(usingthe



keys.

11. Todisplayallresultsfortheselectedpanel,pressthekey. 

12. Todisplayresultsspecifictoonedate,typeinthedate.Tocorre ct,pressthekeytocleartheentire

number.Thentypeinthecorrectnumber.

13. Pressthekey.

14. All

resultsfromtestsrunbeforeandincludingthedateyouselectedfortheselectedpanelare

displayed.

15. Usethe



keystoviewtheentirerecord.

16. Pressthekeytomakeaprintedcopy.

17. PressthekeytouploadtheselectedresultstoLIS.



QCResults

Options:

Theresultsofthesequalitycontrol(QC)testscan beretrievedfromthe

QuidelTriageMeterPro’smemory:



QualityControl(QCtest) Resultscanberetrievedby:

QCSampleResults PanelType

QCSampleLotNumber(L/N)

DeviceLotNumber(L/N)

UserID

FromDate

TillDate

ViewAll(Default)

QCDeviceResults UserID

FromDate

TillDate

ViewAll(Default)

ReagentLots–QC (DefaultstoViewAll)



ToretrieveQCResultsfortheQCSampleandtheQCDevice,selecttheoptiondesiredandfollowthe

directions.



 MainMenu

 RecallResults

NOTE

:Youmaychoosemorethanoneoftheoptionsforrecallingresultsinordertomoreprecisely

definetheinformation you wanttorecallfromtheQuidelTriageMeterPro’smemory.Whenyouchoose

multipleoptions,firstmakeselectionsandinputvaluesinallthecategoriesyouhavechosen.The npress



theENTERkey.

Page55of86



QCSampleLotNumber(L/N)

ToretrieveresultsbasedonthelotnumberoftheQCSampleused:

1. PressthekeytopowertheQuidelTriageMeterProon.

2. FromtheMAINMENUselect RECALLRESULTSusingthekeys.



3. Pressthekey.

4. SelectQCRESULTSusingthe



keys.

5. Pressthekey.

6. SelectQCSAMPLERESULTSusingthe



keys.

7. Pressthekey.

8. SelectPANELTYPEusingthe



keys.

9. Usethe



keystoselectthedesiredpanel.

10. SelectQCSAMPLE

L/Nusingthe



keys.

11. TypeintheQCSamplelotnumberofthetestdevice.Tocorrect,presstocleartheentirenumber.

Thentypeinthecorrectnumber.

12. Pressthekey.

13. AllresultsfromtestrunontherequestedQCSamplelotnumberforthe

selectedpanelaredisplayed.

14. Usethe



keystoviewtheentirerecord.

15. Pressthekeytomakeaprinted copy. 

16. PressthekeytouploadtheselectedresultstoLIS.



DeviceLotNumber(L/N)

ToretrieveQCSampleresultsbasedonthelotnumberofthetestdevicesused:



1. PressthekeytopowertheQuidelTriageMeterProon.

2. FromtheMAINMENUSELECTRECA LLRESULTSusingthe



keys.

 MainMenu

 RecallResults

 QCResults

 QCSam

leResults

NOTE

:Todisplayallresultsfortheselectedpanel,leavetheQCSampleL/Nblank.

 MainMenu

 RecallResults

 QCResults

 QCSampleResults

Page56of86

3. Pressthekey.

4. SelectQCRESULTSusingthe



keys.

5. Pressthekey.

6. SelectQCSAMPLERESULTSusingthe



keys.

7. Pressthekey.

8. SelectPANELTYPEusingthe



keys.

9. Usethe



keystoselectthedesiredpanel.

10. SelectDEVICEL/N

usingthe



keys.

11. Typeinthedevicelotnumberfromthesideoftheboxoftestdevices.Tocorrect,pressthekeyto

cleartheentirenumber.Thentypeinthecorrectnumber.

12. Pressthekey.

13. AllQCresultsthathavebeenrunonthe

requestedlotnumberfortheselectedpanelaredisplayed.

14. Usethe



keystoviewtheentirerecord.

15. Pressthekeytomakeaprintedcopy.

16. PressthekeytouploadtheselectedresultstoLIS.



UserID

ToretrieveQCresultsfromtestsrunontheQuidelTriageMeterProstarting

withtheuseryouselect:

1. PressthekeytopowertheQuidelTriageMeterProon.



FromtheMAINMENUselectRECALLRESULTSusingthe



keys.

3. Pressthekey.

4. SelectQCRESULTSusingthe



keys.

5. Pressthekey.

6. Selecttheappropriatemenu,QCSAMPLERESULTSorQCDEVICERESULTSusingthe



keys.

7. Pressthekey.

8. IfQCSAMPLERESULTS,selectPANELTYPEusingthe



keys.

9. Usethe



keystoselectthedesiredpanel.

10.SelectUSERID

usingthe



keys.

11.Presstheke y.

12.TypeintheuserID.Tocor rect,pressthekeytocleartheentireID,orselecttheincorrectcharacter

byusingthe



keys.ThentypeinthecorrectID.

13.Presstheke y.

14.AllQCSampleorQCDevice

resultsfromtestsrunbytherequesteduser,fortheselectedpanelifQC

Sample,aredisplayed.

 MainMenu

 RecallResults

 QCResults

 QCSampleResults

 QCDeviceResults 

Page57of86

15.Usethe



keystoviewtheentirerecord.

16.Pressthekeytomakeaprintedcopy.

17.PressthekeytouploadtheselectedresultstoLIS.



FromDate

ToretrieveQCresultsfromtestsrunontheQuidelTriageMeterProstarting

withadateyouselect:

1. PressthekeytopowertheQuidelTriageMeterProon.

2. FromtheMAINMENUselect RECALLRESULTSusingthe



keys.



3. Pressthekey.

4. SelectQCRESULTSusingthe



keys.

5. Pressthekey.

6. Selecttheappropriatemenu,QCSAMPLERESULTS

orQCDEVICERESULTSusingthe



keys.

7. Pressthekey.

8. IfQCSAMPLERESULTS,selectPANELTYPEusingthe



keys.Usethe



keystoselectthe

desiredpanel.

9. SelectFROMDATEusingthe



keys.

10. Pressthekey.

11. Typeinthedate.

Tocorrect,pressthekeytocleartheentirenumber.Thentypeinthecorrect

number.

12. Pressthekey.

13. Allresultsfromtestsrunfromthedateselected,fortheselectedpanelifQCSample,aredisplayed. 

14. Usethe



keystoviewtheentirerecord.

15. Press

thekeytomakeaprintedcopy.

16. PressthekeytouploadtheselectedresultstoLIS.



TillDate

ToretrieveQCresultsfromtestsrunontheQuidelTriageMeterProbeforeand

includingadateyouselect:

1. PressthekeytopowertheQuidelTriageMeterProon.

2. FromtheMAINMENUselect RECALLRESULTSusingthe



keys.

3. Pressthekey.

4. SelectQCRESULTSusing

the



keys.

5. Pressthekey.

6. Selecttheappropriatemenu,QCSAMPLERESULTSorQCDEVICERESULTSusingthe



keys.

7. Pressthekey.

8. IfQCSAMPLERESULTS,selectPANELTYPEusingthe



keys.Usethe



keystoselectthe

desiredpanel.



 MainMenu

 RecallResults

 QCResults

 QCSampleResults

 QCDeviceResults

 MainMenu

 RecallResults

 QCResults

 QCSampleResults

 QCDeviceResults 

Page58of86

9. SelectTILLDATEusingthe



keys.



10. Pressthekey.

11. Typeinthedate.Tocorrect,pressthekeytocleartheentirenumber.Thentypeinthecorrect

number.



12. Pressthekey.

13. Allresultsfromtestsrunbeforeandincludingthedateselected,fortheselectedpanelifQCSample,are

displayed.



14. Usethe



keystoviewtheentirerecord.

15. Pressthekeytomakeaprintedcopy.

16. PressthekeytouploadtheselectedresultstoLIS.



ReagentLots–QC

AlistofReagentCODECHIPmodulesinmemory,alongwithcorresponding

expirationdatesforaQCSamplecanberecalledfrommemory.



Thelistwillcontain:LotNumber,PanelType,ExpirationDate



 



 



 



 





 

 IftheQCexpirationdatehaspassed(expired),thedatewillbeinreversevideo(lighttextonadark

background).

 IftheQCforthelothasfailed,thewordFAILEDwilla ppearinplaceofanexpirationdate.



 If

aCODECHIPhasbeeninstalledforanewlot,butQChasyettobeestablished,thewordsNOTRUN

willappearinplaceoftheexpirationdate.

 IfQC frequencyissettonone,thereagentlotexpirationdatewillbedisplayed. 



REAGENTLOTSͲQC 

 

DLN PANEL EXP

47067 CARDIAC 12Ͳ16Ͳ17

48741 CARDIAC 09Ͳ04Ͳ18

48197 BNP NOTRUN

47827 DRUGSCREEN FAILED

  

PRESSPRINTORPRESSENTER

TheReagentLots–QCScreen



ArchiveLastTest

ThisfunctionwillsavedetailedinformationregardingthelastperformedtestforanalysisbyQuidel.Usethis

functionwhenrequestedbyQuidel.



Thisfunctionshouldbe usedwhenaveryunusualtestresultisreceivedandwhenthelaboratorywishesto

havethemeterevaluatedfurther.ARCHIVELASTTESTwillonly

beabletosavedatafromthemostrecent

testrun.



 MainMenu

 RecallResults

 QCResults

 ReagentLots–QC

 ArchiveLastTest

Page59of86

Misc.TestResults

Options:

Misc.Testresultscanberetrievedbasedonavarietyofcriteria:

 Misc.TestID

 TestDeviceLotNumber(L/N)

 UserID

 FromDate 

 TillDate



Misc.TestID

ToretrieveresultsbasedontheMisc.TestID:

1. PressthekeytopowertheQuidelTriageMeterProon.

2. FromtheMAINMENUselect RECALLRESULTSusingthe



keys.



3. Pressthekey.

4. SelectMISC.TESTRESULTSusingthe



keys.

5. Pressthekey.

6. SelectPANELTYPEusingthe



keys.

7. Usethe



keystoselectthedesiredpanel.



8. Choosetheresultsyouwanttosee:

 IfyouwanttoseeallMisc.Testresults,pressthekey.AlltheMisc.TestresultsintheQuidelTriage

MeterPro’smemoryfortheselectedpanelwillbedisplayed.

 Forindividual Misc.Testresults:

a. SelectMISC.TESTIDusingthe



keys.

b. Typeorscanin

theMisc.TestID.Tocorrect,pressthekeytocleartheentireID,orselectthe

incorrectcharacterbyusingthe



keys.ThentypeinthecorrectID.

c. ToselectaMisc.TestIDwithalphacharacters,usethekeytoenteralphacharactersorusethe

keyinplaceofthealphacharacter.

d. Pressthekey.Allresults oftherequestedMisc.TestIDfortheselectedpanelwillbedisplayed.

9. Usethe



keystoviewtheentirerecord.

10. Pressthekeytomakeaprinted copy. 

11. Pressthekeyto

uploadtheselectedresultstoLIS.



 MainMenu

 RecallResults

 MainMenu

 RecallResults

 MiscTestResults

NOTE

:Youmaychoosemorethanoneoftheoptionsforrecallingresultsinordertodefinemoreprecisely

theinformationyouwanttorecallfromtheQuidelTriageMeterPro’smemory.Whenyouchoosemultiple

options,firstinputvaluesinallthecategoriesyouhavechosen.ThenpresstheENTERkey.



Page60of86

TestDeviceLotNum b er(L/N)

Toretrieveresultsbasedonthelotnumberofthetestdevicesused:

 Pressthekeytopower theQuidelTriageMeterProon.



2. FromtheMAINMENUselect RECALLRESULTSusingthe



keys.

3. Pressthekey.

4. SelectMISC.TESTRESULTSusingthe



keys.

5. Pressthekey.

6. SelectPANELTYPEusingthe



keys.

7. Usethe



keystoselectthedesiredpanel.

8. SelectDEVICEL/N

usingthe



keys.

9. Todisplayallresultsfortheselectedpanel,pressthekey.

10. Todisplayresultsspecifictoonelot,typeinthelotnumber ofthetestdevice.Tocorrect,pressthe

keytocleartheentirenumber.Thentypeinthecorrectnumber.

11.

Pressthekey.

12. Allresultsfromtestsrunontherequestedlotnumberfortheselectedpanelaredisplayed.

13. Usethe



keystoviewtheentirerecord.

14. Pressthekeytomakeaprinted copy. 

15. PressthekeytouploadtheselectedresultstoLIS.



 MainMenu

 RecallResults

 MiscTestResults

NOTE

:OnlyenterthefiveͲdigitnumericvalueoftheQClotnumber.

Page61of86

UserID

ToretrieveresultsfromtestrunontheQuidelTriageMeterProstartingwith

theuseryouselect:

1. PressthekeytopowertheQuidelTriageMeterProon.

2. FromtheMAINMENUselect RECALLRESULTSusingthe



keys.

3. Pressthekey.

4. SelectMISC.TESTRESULTSusingthe



keys.

5. Pressthekey.

6. SelectPANELTYPEusingthe



keys.

7. Usethe



keystoselectthedesiredpanel.

8. SelectUSERIDusingthe 



keys.

9. Todisplayallresultsfortheselectedpanel,pressthekey .

10. Todisplayresultsspecificto

oneUserID,typeintheUserID.Tocorrect,presstocleartheentireID,

orselecttheincorrectcharacterbyusingthe



keys.ThentypeinthecorrectID.

11. Pressthekey.

12. Allresultsfromtestsrunbytherequesteduserfortheselectedpanelare

displayed.

13. Usethe



keystoviewtheentirerecord.

14. Pressthekeytomakeaprinted copy. 

15. PressthekeytouploadtheselectedresultstoLIS.

FromDate

ToretrieveresultsfromtestrunontheQuidelTriageMeterProstartingwithadate

youselect:

 Pressthekeytopower theQuidelTriageMeterProon.

2. FromtheMAINMENUselect RECALLRESULTSusingthe



keys.

3. Pressthekey.

4. SelectMISC.TESTRESULTSusingthe



keys.

5. Pressthekey.

6. SelectPANELTYPEusingthe



keys.

7. Usethe



keystoselectthedesiredpanel.

8. SelectFROMDATE

usingthe



keys.

 MainMenu

 RecallResults

 MiscTestResults

 MainMenu

 RecallResults

 MiscTestResults

Page62of86

9. Todisplayallresultsfortheselectedpanel,pressthekey.

10. Todisplayresultsspecifictoonedate,typeinthedate.Tocorre ct,pressthekeytocleartheentire

number.Thentypeinthecorrectnumber.

11. Pressthekey.

12. Allresultsfromtestsrunfrom

thedateselectedfortheselectedpanelaredisplayed.

13. Usethe



keystoviewtheentirerecord.

14. Pressthekeytomakeaprintedcopy.

15. PressthekeytouploadtheselectedresultstoLIS.



TillDate

ToretrieveresultsfromtestrunontheQuidelTriageMeterProbefoeandincluding

adateyouselect:

1. PressthekeytopowertheQuidelTriageMeterProon.

2. FromtheMAINMENUselectRECALLRESULTSusingthe



keys.



3. Pressthekey

4. SelectMISC.TESTRESULTSusingthe



keys.

5. Pressthekey.

6. SelectPANELTYPEusingthe



keys.

7. Usethe



keystoselectthedesiredpanel.

8. SelectTILLDATEusingthe



keys.

9. Todisplayallresultsfortheselected

panel,pressthekey.

10. Todisplayresultsspecifictoonedate,typeinthedate.Tocorre ct,pressthekeytocleartheentire

number.Thentypeinthecorrectnumber.

11. Pressthekey.

12. Allresultsfromtestsrunbeforeandincludingthedateyouselectedfor

theselectedpanelare

displayed.

13. Usethe



keystoviewtheentirerecord.

14. Pressthekeytomakeaprintedcopy.

15. PressthekeytouploadtheselectedresultstoLIS.



 

 MainMenu

 RecallResults

 MiscTestResults

Page63of86

PrintAllResults

Options:

AllstoredresultscanbeprintedfromtheQuidelTriageMeterPro’s

memory.

 PatientResults 

 QC SampleResults 

 QC DeviceResults

 Misc.TestResults



PatientResults

ToprintallPatientResults:

1. PressthekeytopowertheQuidelTriageMeterProon.

2. FromtheMAINMENUselect RECALLRESULTSusingthe



keys.

3. Pressthekey.

4. SelectPRINTALLRESULTSusingthe



keys.



5. Pressthekey.

6. SelectPATIENTRESULTSusingthe



keys.

7. Pressthekey.

8. Typeorscaninyouridentification(UserID).Tocorrect,presstocleartheentireID,orselectthe

incorrectcharacterbyusingthe



keys.ThentypeinthecorrectID.



9. Pressthekeytomakeaprintedcopy.



QCSampleResults

ToprintallQCSampleResults: 

1. PressthekeytopowertheQuidelTriageMeterProon.

2. FromtheMAINMENUselect RECALLRESULTSusingthe



keys.

3. Pressthekey.



4. SelectPRINTALLRESULTSusingthe



keys.

5. Pressthekey.

6. SelectQCSAMPLERESULTSusingthe



keys.

7. Pressthekeytomakeaprintedcopy.

 MainMenu

 RecallResults

 MiscTestResults

 MainMenu

 RecallResults

 PrintAllResults

NOTE

:Whenprintinglargequantities ofpatientresults,itisrecommendedtofirstinsertafullrollof

paper.

NOTE

:IftheUserIDbypassisON, themeterwillnotaskyoutoenteraUserID.

Page64of86



QCDeviceResults

ToprintallQCDeviceResults:

1. PressthekeytopowertheQuidelTriageMeterProon.

2. FromtheMAINMENUselect RECALLRESULTS

usingthe



keys.

3. Pressthekey.

4. SelectPRINTALLRESULTSusingthekeys.

5. Pressthekey.

6. SelectQCDEVICERESULTSusingthe



keys.

7. Pressthekeytomakeaprintedcopy.



Misc.TestResults

ToprintallMisc.TestResults:

1. PressthekeytopowertheQuidelTriageMeterProon.

2. FromtheMAINMENUselect RECALLRESULTS

usingthe



keys.

3. Pressthekey.

4. SelectPRINTALLRESULTSusingthekeys.

5. Pressthekey.

6. SelectMISC.TESTRESULTSusingthe



keys.

7. Pressthekeytomakeaprintedcopy.



UploadResultstoLIS

WheninterfaceddirectlytoanLIS,selectingthisfeaturewillsendalltestresults

totheLIS.Priortothefirstupload,theLISfeaturemustbeactivatedfromthe

SetParametermenuitemusingtheSupervisorCODECHIP



module.



DeleteResults

Purpose

TheDeletefunctionisusedtoremoveallpatienttestinformationfromtheQuidelTriageMeterPromemory.



 MainMenu

 RecallResults

 UploadResultstoLIS

 MainMenu

 RecallResults

 PrintAllResults

NOTE

:Thedeletefunction isavailableonlywhentheSupervisorCODECHIPmoduleisinsertedinthe

QuidelTriageMeterProCODECHIPmodulePort.

Page65of86

HE

QuidelTriageMeterProMemory

WithintheQuidelTriageMeterPro,PatientResultmemorycanhold750datasets,QCSamplecanhold200

datasets,QCDevicecanhold70datasets,andMisc.Testcanhold250datasets.Whenthememoryisfull,

theoldestresultisautomatically overwrittenwhenanewresultis

added.Themeterdisplayalertstheuser

asthepatientmemorybecomesfull.



WARNING



PATIENTMEMORYHAS

SPACEFORXXXMORE

RECORDS



PRESSENTER

TheMemoryAlertScreen



 IMPORTANT:

TheDeletefunctionpermanentlyremovesallpatientdatafromthemetermemory.

Beforecontinuing,youmaywishtofirstprintresults(oruploadtoyourdatamanagement

system/LIS).QCorMisc.TestResultsca nnotbemanuallydeleted.



DeletePatientResult

Thisfunctionwilldeleteallpatientresultsinmetermemory.Sincethisactionisnot

reversible,themeterwillrequiretwoconfirmations ofintenttodeleteresults.



1. InserttheSupervisorCODECHIPmoduleintheCODECHIPmodulePort



2. FromtheMAINMENU,selectDELETERESULTSusing

thekeys.





 MainMenu

 DeleteResults

Page66of86



8:23AM01•20•18

RUNTEST

RECALLRESULTS

INSTALLNEWCODECHIP

SETPARAMETERS

DELETERESULTS



SELECTWITHvOR^ANDPRESSENTER

PRESSEXITTOEJECTDEVICE

TheSupervisor’sMainMenu



3. Pressthekey.

4. Awarningmessageonthescreenstates:DELETEPATIENTRESULT.

5. Ifthisisacceptable,pressthekey.(Ifthisisnotacceptable,pressthekey).

6. Amessageonthescreenstates:ALLPATIENTRESULTSWILLBEDELETED.



7. Pressthekeytodeleteallpatientresults.(Ifyoudonotwanttodeleteallpatientresults,

pressthekey).



DisplayBacklight

TheQuidelTriageMeterProhasthecapabilityfortheoperatortobacklightthedisplayforproviding

improvedclaritydependingonambientlightingconditions.Thebacklightfeaturecanbecontrolledbythe

backlightbuttononthekeypad.Whenthebacklightbuttonispressed,thebacklightinitially

comesonatmaximumbrightness.Subsequent

pressescyclethebacklightfrombrighttodimandthento

off.Tosavepower,thebacklightturnsoffifnokeyshavebeenpressedfor15seconds.Pressinganykeywill

restorethebacklighttothepreviouslevel.



NOTE:PresstheEXITkeytocancelatanytimebeforestep7.

Page67of86



AlphaNumericMode

TheQuidelTriageMeterProhasthecapabilityfortheoperatortoenterbothnumericandalphacharacters

fromthekeypad.Thekeypadoperatesinnumericmodeuntilalphamodeisactivatedbypressingthe

key.Themeterstaysinalphamode,indicatedbytheletters"ABC"shownatthetopof

thedisplay,untilthe

keyispressedagain.Wheninalphamode,pressinganykeycausesthealphacharactertobe

displayed.



1

Ͳ/#()*.\

7

PQRS

2

ABC

8

TUV

3

DEF

9

WXYZ

4

GHI

0 noalphacharacterisdispla yed

5

JKL

. noalphacharacterisdispla yed

6

MNO



Thefirstpressofabuttoncausesthefirstlettertobedisplayed.Thesecondpressofthesamebuttonwithin

threesecondscausesthesecondlettertobedis played.Thethirdpressofthesamebuttonwithinthree

secondscausesthethirdlettertobedisplayed.



Afterthe

lastcharacterinasequenceisdisplayed,thenextbuttonpressofthesamebuttonwithin3

secondsdisplaysthefirstcharacterandthesequenceisrepeated. 



Ifmorethanthreesecondspasswithouttheoperatorpressingthebutton,thenextpressofthatbutton

causesthefirstcharacterto

bedisplayed.Ifanewbuttonispressed,thefirstcharacterofthenewbuttonis

displayedwithsubsequentpressesrepeatingthesequence.





Page68of86

ServiceandMaintenanceProcedures

Ifanyserviceormaintenanceisrequired,theQuidelTriageMeterProshouldbesenttothemanufactur er.

Nomaintenanceotherthanpaper/batteryreplacementandperiodicexternalcleaningisrequiredofthe

operator.



PaperReplacement

ChangingPaperBetweenFunctions

1. TearoffanyexcesspaperstickingoutoftheQuidelTriageMeterPro.

2. Removethepapercompartmentcoverbypullinguponthecoverasindicatebythearrowontheback

ofthecover.



3. Removeunusedpaperortheemptypaperspindlefrompapercompartment.

4. Tearorcutaclean,straightedgetofeedintotheprinter.Donotcutpaperatanangle,astheprinter

mustsensetheedgeofthepaperalongthefeedpath.



5. Insertthenewrollofpaperintothepapercompartment.



6. Positionthepapersuchthatthepaperwillfeedfromundertheroll(asopposedtooverthetopofthe

roll,seepicture,above).



7. Insertthepaperedgeunderthepaperroller(platen)untilitfirmlyseatsorresistanceisfelt.

8. Pressthekey.



9.

Replacethecoveroftheprinterandcontinueoperation.

NOTE:Theprintercontainsapapersensorandwillfeedthenewpaperrollonlywhenpaperwithaclean

straightlineispressedintothepaperroller.



NOTE:IfPAPERFEEDbuttonispressedbeforetheprintersensesthepaper,theprinterwillnotrespond

tothecommand.



NOTE:Theprinterutilizesthermalpaper,iftheprintedpaperisblankafterreplacingaroll,verifythatthe

paperrollisnotupsidedown.



Page69of86

ChangingPaperWhilePrinting

IfthemeterrunsoutofpaperwhileinthemiddleofaprintingtaskandisdisplayingthemessagePRINTER

FAILURE,CHECKPRINTERORREPLACEPAPER,thepapermaybechangedandtheprintjobcontinued

withoutlossofdataorreprintingfromthebeginning.Performthefollowingstepspriortopressing anynew

keys:

1. Removethepapercompartmentcoverbypullinguponthecoverasindicatebythearrowontheback

ofthecover.



2. Gentlypullremainingpaperslowlyupthrough theprinter.

3. Removepaperspindlefromthepapercompartment.

4. Tearorcutaclean,straightedgetofeedintotheprinter.Donotcutpaperatanangle,astheprinter

mustsensetheedgeof

thepaperalongthefeedpath.



5. Insertthenewrollofpaperintothepapercompartment.

6. Positionthepapersuchthatthepaperwillfeedfromundertheroll(asopposedtooverthetopofthe

roll,seepicture,above).

7. Insertthepaperedgeunderthe

paperroller(platen)untilitfirmlyseatsoraresistanceisfelt.

8. Presstheke y.



9. Whentheprinterbeginstopullthepaperin,releasethepaper.TheprinterwillfeedafewlinesandreͲ

commencetheprintjob.Toensurenodataislost,the

printerwillreprintuptotheprevious5lines.

10.Afterthepaperhasappearedabovetheprinter,replacetheprintercover,takingcaretoensurethe

paperdoesnotgetcaughtinsidethemeter.

NOTE:Theprintercontainsapapersensorandwillfeedthenewpaperrollonlywhenpaperwithaclean

straightlineispressedintothepaperroller.



NOTE:IfPAPERFEEDbuttonispressedbeforetheprintersensesthepaper,theprinterwillnotrespond

tothecommand.

NOTE:Theprinterutilizesthermalpaper,iftheprintedpaperisblankafterreplacingaroll,verifythatthe

paperrollisnotupsidedown.



Page70of86



Cleaning

TheQuidelTriageMeterProrequiresminimalmaintenance.Occasionalcleaningoftheexteriorwithmild

soapandwatersolutionissufficient.Afterusingadamp,notwet,spongeorclothtoapplyamildsoapand

watersolutionontheoutsideofthemeter,wipethemeterdryusingasoftcloth

orabsorbenttissue.Donot

allowwatertoseepintotheprinter.Donotimmersethemeterinwaterorotherliquids.



Ifbloodorotherfluidsarenotallowedenoughtimetofullyabsorbintotestdevices,thedevicetrackdoor

mayoccasionallyrequirecleaning.Usingacottonswab

dampenedwithisopropylalcoholandapairof

tweezers,carefullyliftthedoorandcleanbothfrontandbackofthedoor.



CheckBatteryLevel

TheQuidelTriageMeterProcheckstheactivepowersourceafterejectingadeviceorprinting.Tocheckthe

batterypower,navigatetotheMAINMENU,disconnecttheACpowersupply,pressthekey(themeter

attemptstoejectthedevice),andlookfortheLowPowerIndicatorontheMain

Menuofthemeterdisplay.

Iftheflashingindicatorappears,replacethebatteries.



BatteryReplacement

 Turnoffthemeter.

 Removethebatterycoverfromthebottomofthemeterbyslidingthecoverinthedirectionofthe

arrow.

NOTE:Neverinsertanytools,swabs,orcleaningmaterialsintothedevicetrack.

NOTE:Themeterisdesi gnedtoperformandprintatleast100testsbeforenewbatteriesarerequiredtobe

replaced.Whenthemeterisnotinuse,itshouldbeturnedoff.Topreservebatterylife,ensuretheAUTO

POWERͲOFFfunctionissetto1/2HOUR.

Page71of86

 Removethebatteries.Somecountriesrequirethatbatteriesbedisposedofinaccordancewithspecific

governmentalregulations(Directive2006/66/EC).Disposeofthebatteriesincompliancewithlocal

regulations.

 InsertfoursizeAA1.5Ͳvoltbatteriesintothebatterycompartment.Besurethattheplus(+)andminus

(Ͳ)

signsofthebatteriesmatchthesamesignsembossedinthebatterycompartment

 Replacethecovertothebatterycompartment.



TotalQualityAssurance

Introduction



Qualityassuranceprogramscontrolandmonitoranalyticalmethods.Thequalitycontrolofanalytical

methodsachievestwobasicgoals:

1. Ensuresthatthereagentsandinstrumentareworkingproperly

2. Ensuresthattheprocedurewasperformedcorrectly

Themechanismbywhichanalyticalmethodsaretraditionallycontrolledisthroughtheuseof

liquidcontrol

specimenscontainingknownamountsofanalytes.



Overthelast15yearsadvancesintechnologyhavechangedthemannerinwhichthediagnosticreagents

areconfigured.AssaysystemsforthePointͲofͲCarearegenerallyunitizedtestingdevicesthataredistinct

fromtraditionallaboratoryͲbasedanalyzers.TheQuidelTriagetests

areunitizedteststhatdonotrequire

NOTE:Ifthemeterdoesnotpoweronafterreplacingbatteries,verifythebatteriesarelinedupaccording

tothesymbolsinthebatterycompartment.

NOTE:Rechargeablebatteriesareauthorizedforuse,howeverduetothenatureofthesetypesof

batteries,itisexpectedtheywillrequirerechargingmorefrequently.TheQuidelTriageMeterProdoesnot

containabuiltͲinbatterycharger,rechargeablebatteriesmustberechargedoutsideofthemeter.

NOTE:Formoredetailedinformation,contactQuidel.

Page72of86

additionalreagents.Eachdevicecontainsafullcompleme ntof reagentsthatarerequiredtoperformthe

immunoassay.



TheQuidelTriagetestshavebeendesignedtoincludeassaycontrolsineachtestdevicethatmonitorthe

assayprocedureandthereagentintegrity.Theassaycontrolspresentauniqueandvaluableextensionto

thetraditionalapproachtoqualitycontrolusingliquidreagents.Iftheproductisstoredunderspecifie d

conditions,

properfunctioningoftheassaycontrolsindicatesthatthetestdeviceisvalidandproper

adherencetoassayprotocolhasbeenfollowed.TheassaycontrolsintheQuidelTriagetestsrequirethe

needtoreͲthinkthefrequencywithwhichexternalqualitycontrolspecimensshouldbetested.



TheQuidelTriage

testshavebeendesignedtoyieldlong Ͳtermreagentstability.Inaddition, thesystem

providesqualitycontrolparametersinthreeseparateanddistinctcategories:

 Internaldevicecontrols

 Meterelectroniccontrols

 Softwarecontrols.

Thecombinationofthesequalitycontrolfeaturesprovides moreinformationaboutthevalidityofeach

assaythancanbeprovidedbythemoretraditionalmethodsofreagentandassayprocedurevalidation.



QualityAssuranceFunctions

1. InternalDeviceQualityAssurance

 InternalPositiveControlZone

 BaselineControlZone

 TimingControlZone

 ZoneQualityRequirements(TraceQC)

2. MeterQualityAssurance

 SelfͲTestMode

 InternalCalibrationChip

 ElectronicQCDevice

 BarCode

3. SoftwareQualityAssurance

 SupervisorCODECHIP

module

 UserID#

 PatientID# 

 Resultmemorystorage

 QCFrequency

 QCLockouts 

4. QualityControlSamples



InternalDeviceQualityAssurance

TheInternalControlZonesarebuiltͲin functionalimmunoassays.Thiscontrolverifiesthatthedevice

functionedproperlyandthattheassaywascorrectlyperformed.TheInternalPositiveControlZoneensures

thattheantibodies,thereagentreconstitution,thetimegateandthedeviceflowarefunctioning properly.

Themanufacturersetsacceptablerangesfor

thecontrolzonesforeachlotofreagents.



TheBaselineControlZonemonitorsthepresenceofinterferingsubstancesinthepatientsamplethat may

altertheimmunoassayprocess.Ifaspecimencontainsasubstancethathasamajoreffectonthehighand

Page73of86

lowcontrolsandthebaselinecontrolandtherebyontheimmunoassay,theresultsarenotdisplayedand

erroneousresultsarenotreported.



TheTimingControlZonemonitorsassaycompletion.Ifaninadequateamountofspecimenisaddedtothe

testdeviceorifaspecimenclotsinthedevice,this

controlwillpreventthedisplayoftheresults.



ATraceQCalgorithmhasbeenprogrammedwhichevaluates the size,locationandsignaltonoiseratioof

eachzoneonthedevice.Aberrationsinzonequalityexceedingpresetlimitswillcauserejectionofoneor

moreoftheassayresults.



MeterQualityAssurance

TheSelfͲTestModeisinitiatedeachtimethemeteristurnedON.IntheselfͲtestmodethemeterscansan

InternalCalibrationChip.Eachcalibration chipscanisusedtovalidateandadjust,ifnecessary,themeter

calibration.IntheselfͲtestmode,theavailablememoryforpatientresults

ischecked.Whenthecapacityis

belowapreͲsetlimit,theremainingcapacityisrelatedviaascreenmessage.Thesoftwareprogramis

evaluatedandisterminatedifcorrupted.SoftwaretestresultsandCODECHIPmoduledataareverifiedfor

integritybeforeeachuse.



AQCDeviceisprovided

witheachmetertoallowtheusertofurtherchecktheintegrityofthemeter.The

simulatorcontainssixfluorescentzonesofvaryingintensitythataremeasuredbythemeter.TherearepreͲ

programmedacceptablerangesforthesixzones.Inaddition,thezonesallowthemetertocheckfor

horizontalandverticalalignmentofthezonemeasurementtoverifylaseralignmentanddevicetransport.

TheQCDevicealsoconfirmslaserstability.



ABarCodeisprintedonthebottomofeverytestdevicetoidentifythereagentlotnumberandtoprevent

theuseofexpiredreagents.



SoftwareQualityAssurance

ThesoftwareQAiscontrolledthroughavarietyofsoftwarefeatures,someofwhichcanbeoptional

dependingontheenvironmentinwhichtheassayisperformed.InaPointͲofͲCarelocation,adesignated

supervisorcanselectprogramparameterstoensureadherencetoqualitystandards.Inacentrallaboratory

location,

selectedparameterscanbebypassedifdesired.



ASupervisorCODECHIPmoduleisprovidedwitheachmeter.ThisCODECHIPmoduleallowsaccessto

meterfunctionsnotavailabletotheroutineuser.Theadditionalfunctionsareselectionofparameter

settingsanddownloadingandde letionofresultsfromthemetermemory.



AUserIDcanbeassignedinthesoftwaretolimitaccesstothepatienttestingmodetoonlythose

individualswhohavebeenproperlytrainedandhavedemonstratedtestingproficiency.AUserIDand

expirationdateareprogrammedintothemetermemoryandaresubsequentlyassociatedwithallpatient

resultsgeneratedbytheuser.Thisallowsthesupervisortoreviewusers’testingfrequency,andintheevent

offrequenttestfailures,toidentifypotentialproblemsintraining.



AnadditionalsecurityfeatureoftheUserIDisthepartialmaskingoftheIDondisplaysandprintouts.This

preventsunauthorized

individualsfromdetectingandusinganexistingUserID.Thisfeatureisoverridden

whentheSupervisorCODECHIPmoduleisinstalled.



Page74of86

APatientIDisrequiredforallpatienttestsperformed.All QC sampleandpatientresultsarestoredinthe

meter’smemoryandcanbedownloadedtoalaboratoryinformationsystem(LIS)oranexternaldata

managementsoftwareprogramforfurtherviewingandprintingofqualitycontrolreports.



TheSupervisor

canselecttheQCFreque ncyforperformingexternalliquidcontrolsamples.Whenitistime

toperformexternalQCsamples,theusermusttesttheexternalliquidcontrolsandobtainacceptable

resultsbeforepatientsamplescanbetested.WhenQCsampleshavebeensuccessfullyperformed,theuser

isallowedtoperform

testsonpatientsamples.IfQCsamples arenotwithinanacceptablerange,aQC

Lockoutfunctionpreventstestingofpatientsamples.Ifdesired,thesupervisorinacentrallabsettingcan

bypassthisfunction.Iftestdevicecontrolsareoutofrange,aQCLockoutfunctionisactivatedand

patient

testresultsareblockedfromviewingandprinting.Thispreventsunacceptableresultstobecommunicated

toandusedbythephysician.



Additionally,iftestdevicesareexpired,aQCLockoutfunctionisactivatedandpreventstestingusing

expiredtestdevices.



QualityControlSamples

Itisstillvaluabletoapplythetraditionalapproachtoqualitycontrolbytestingqualitycontrolsamples.

Thesecontrolswillcheckthetotalintegrityofthesystem.Theintervalforanalyzingthesecontrols,

however,canbeextendedduetothemanyother TotalQualityAssurancefeaturesinherentintheQuidel

Triage

tests.



TheQuidelTriagetestshavebeendesignedtomaximizeTotalQualityAssuranceinany testing environment.

ThecombinationoftheQCfeaturesoftheQuidelTriagetestsreducetheimpactofproceduralerrors,

ensurereagentintegrity,andassurethatpatientresultsareaccurateeachandeverytimeatest

is

performed.BasedonthecurrentCLIAguidelinesandotherregulatingbodies,Quidelmakesthefollowing 

QCrecommendations:

 RuntwolevelsorPOSandNEGexternalliquidcontrolsamplesasa ppropriate witheachnewlotof

reagentsandonceeverythirtydayswithcontinueduseofthesamereagentlot

number

 RuntheQCDevicedaily.



NotesRegardingSoftwareControls

1. UserIDAccess

 Topreventuntrainedpers ons fromperformingatest,avalidUserID(1Ͳ16charactersinlength)

mustbeenteredbeforeaccessisgiventotheRUN

TESTfunctioniftheUserIDbypassisOFF.Ifa

UserIDBypassisON,thenanyonecananalyzeatest.

 Topreventunauthorizedpersonsfromaccessingpatientinformation,avalidUserIDmustbe

enteredbeforeaccessisgiventotheRECALL

PATIENTRESULTSfunctionsiftheUserIDbypassis

OFF.IfaUserIDBypassisON,thenanyonecanrecallpatientdata.RECALL

PATIENTRESULTS

functionsincludere callingpatientresults,printingpatientresults,andrecallingthelasttestrunon

themeterwhenthelasttestisapatientsample,

 TheUserIDBypassiscontrolledbytheSET

PARAMETERSfunction,whichrequiresaSupervisor

CODECHIPmoduleforaccess.

 AccessisavailabletoanyonewantingtoRECALL

NONͲPATIENTRESULTSfrommemoryorINSTALL

CODECHIP.

2. OutͲofͲRangeFlags

Page75of86

 Ifapatientisoutsidethenormalrangeforanyoftheanalytes,thentheresultwillbeflaggedby

reversevideo,thatis,thebackgroundoftheresultwillbeblackandthevalueinwhitenumbers.A

warningwillbedisplayedbelowtheresults:

PATIENTRESULTABNORMAL

 IftheInternalQCzonesforthedeviceoraspecificanalyteareunacceptable,theanalyte(s)in

questiondisplayanexclamationpoint(!)inplaceofavalueandawarningisdisplayed:

INTERNALQCOUTOFRANGE.

 IftheQCSampleforaspecificanalyteonthatdevicelotisunacceptable,theanalyteinquestionwill

displayapoundsign(#)inplaceofavalueandawar ningisdisplayed:

QCSAMPLEOUTOFRANGE.

 IfbothQCSampleandInternalQCerrorsarepresentforaspecificanalyte,bothapoundsignandan

exclamationpoint(#

!)willbedisplayedinplaceofavalueandbothwarningsaredisplayed:

INTERNALQCOUTOFRANGEand#QCSAMPLEOUTOFRANGE.

3. BlockedResults

WhenQCerrorconditionsexistonatestdevice,whetherforaspecificanalyteortheentiretestpanel,

theanalytesinquestionareblockedfromviewandreplacedwithanOutofRangeFlag(!and/or#).The

errorconditionmustberemediedandthe

testrepeatedtoobtainaresult.

4. QCSampleFrequency

 Howoftenanexternalliquidcontrol, QCSample,shouldberuncanbeselectedunderSET



PARAMETERS.Ifthetimeintervalhasexpired,QCSamplesmustberunandacceptableresults

obtainedbeforeapatientsamplecanbetested.

 AlistoftestdevicelotsandthedatethattheQCSampleexpirescanbeviewedandprintedby

selectingREAGENTLOTS–QCunder

theRECALLRESULTSmenu.

5. SupervisorAccess

Topreventmisuse,theSupervisorCODECHIPmoduleisrequiredforaccesstotheSETPARAMETERSand

DELETERESULTSfunctions ofthesoftware.TheSupervisorCODECHIPisuniversalandmaybeusedonany

QuidelTriageMeterPro.



LimitedWarranty.FORTHEAPPLICABLEWARRANTYPERIOD,

QUIDELWARRAN TSTHATEACHPRODUCT

SHALLBE(I)OFGOODQUALITYANDFREEOFMATERIAL DEFECTS,(II)FUNCTIONINACCORDANCEWITHTHE

MATERIALSPECIFICATIONSREFERENCEDINTHEPRODUCTMANUAL,AND(III)APPROVEDBYTHEPROPER

GOVERNMENTALAGENCIESREQUIREDFORTHESALEOFPRODUCTSFORTHEIRINTENDEDUSE

(the“LIMITEDWARRANTY”).IF

THEPRODUCTFAILSTOMEETTHEREQUIREMENTSOFTHELIMITED

WARRANTY,THENASCUSTOMER’SSOLEREMEDY,QUIDELSHALLEITHERREPAIRORREPLACE,ATQUIDEL'S

DISCRETION,THEPRODUCT.EXCEPTFORTHELIMITEDWARRANTYSTATEDINTHISSECTION,QUIDEL

DISCLAIMSANYANDALLWARRANTIES,EXPRESSORIMPLIED,INCLUDINGBUTNOTLIMITEDTO,

ANY

WARRANTYOFMERCHANTABILITY,FITNESSFORAPARTICULARPURPOSEANDNONͲINFRINGEMENT

REGARDINGTHEPROD UCT.QUIDEL'SMAXIMUMLIABILITYWITHANYCUSTOMERCLAIMSHALLNOT

EXCEEDTHENETPRODUCTPRICEPAIDBYCUSTOMER.NEITHERPARTYSHALLBELIABLETOTHEOTHER

PARTYFORSPECIAL,INCIDENTALORCONSEQUENTIALDAMAGES,INCLUDING,WITHOUTLIMITATION,LOSS



OFBUSINESS,PROFITS,DATAORREVENUE,EVENIFAPARTYRECEIVESNOTICEINADVANCETHATTHESE

KINDSOFDAMAGESMIGHTRESULT.



TheLimitedWarrantyaboveshallnotapplyiftheCustomerhassubjectedtheProduct tophysicalabuse,

misuse,abnormaluse,useinconsistentwiththeProductManualorInsert,fraud,

tampering,unusual

physicalstress,negligenceoraccide nts.AnywarrantyclaimbyCustomerpursuanttotheLimitedWarranty

shallbemadeinwritingwithintheapplicableLimitedWarrantyperiod.



Page76of86

Appendices



AppendixASpecifications



Physical 

 Size 8.5”x6.25“x2.75”(22.5cmx19cmx7cm)Dx Wx H

 Weight 1.5pounds(0.7kg)withoutbatteries

 Electrical 6vDCat1amp–suppliedvia4AAbatteriesorAC/DCConverter

 Keypad Numericwithspecialfunctionkeys(22total)

Environmental

 Temperature 15ºC–30ºC

 Humidity 10%–85%

 Location Dry,clean,flathorizontalsurfaceawayfromdirectsunlight

Optical

 LightSource LaserDiode–<1milliwatt

 LaserClassification 1

 Detector SiliconPhotodiode

MemoryCapacity

 750PatientRecords 32ReagentLotCODECHIPmodules

 200QCSampleResults 200QCSampleCODECHIPmodules

 70QCDeviceResults 4QCDeviceCODECHIPmodules

 250MiscTestResults

 600UserID's

Miscellaneous

 RSͲ232computerinterfaceport

 ThermalPrinter

 LCDscreendisplay

Options

 ExternalBarCodeReader(rapidentryofUser,Patient,AuxiliaryorMiscTes tID's).

 QuidelTriageCensusDataManagementSoftware.

 QuidelTriageCensusDataManagementSoftwarewithLISConnectivity.

TestDeviceSpecifications

Testdevicespecificinformationisprovidedintheapplicableproductinsert.Theinstrumentanalyzes

immunoassaytestdevicesmanufacturedbyQuidelCardiovascularInc.

Page77of86

AppendixBTroubleshooting

MeterSymptoms

Symptom ProbableCause CorrectiveAction

InvalidResults

a. Inappropriate bodyfluidor

improperlyanticoagulatedsample.

a. Retestsampleusinganewtestdevice

withaproperspecimen.



b. Samplesizeincorrect—toolittle

sample.Testdevice’sinternalQC

controlswillbeoutofrange.

b. Retestsampleonanewtestdevice.

Makesuretheentiretubeisfull.Be

certainthelowerbulbonthepipette

tubecontainsasmallamountfluid

beforeyoupressthetop

bulb.



c. Meterwaspickeduporcarried

verticallywhiletestwasrunning.

Thetestdevice’sinternalQC

controlswillbeoutofrange.

c. Iflessthan30minuteshaspassedsince

preparingthetestdevice,placemeter

onflatsurfaceandreinsertthetest

device.Ifmorethan30

minuteshas

passed,retestsampleonnewtest

device.

Meterwillnotpull

testdevicein.

Hookthatpullstestdeviceintothe

metermaybebroken.

Ifmeterrepeatedlyfailstopullthedevice

in,themetermayneedtobereplaced.

ContactQuidel.

CODECHIPmodule

willnotfitinmeter.

a. CODECHIPmodulemayhavebeen

insertedupsidedown.

a. ReͲinsertCODECHIPmodulerightside

up.



b. CODECHIPmoduleorMeter

contactscouldbebent.

b. TrynewCODECHIPmodule,if

available.Ifstillnotagoodfit,contact

Quidel.

Printerworksbutno

printappearson

paper.

Papermaybeinstalledbackwards. Installpaperreversetocurrentposition.

Printerjam.

Papermayhavebeenfedintothe

meterimproperly.

Carefullyremoveoldpaperoutofthe

printer.Donotinsertanytoolsintothe

printer.

Printerstops

printing

orskipsaline.

Batterypowerlow.

Replacebatteriesorverifypowercordis

installedinthemeterandwalloutlet.

Meterwillnot

poweronormeter

powersoffwhen

runningatest.

a. Batteriesnot installed,drainedor

incorrectlyaligned.

a. Verifybatteriesareinstalled and

correctlyaligned(+)and(Ͳ);replace

batteriesifnecessary.

 b. Powersourcenotpluggedin.

b. Verifypowercordisinstalledinthe

meterandwalloutlet.

Blinkingbattery

icon.

Lowbatterypower. Replacebatteries.

Metercontainsno

batteriesor

batteriesarelow

whenfacilityhas

lossofpower.



AlldataissavedintheMeterexceptdate

andtime.Resetdateandtime.



Page78of86

AppendixBTroubleshooting

MeterMessageorSymptom

Message ProbableCause CorrectiveAction

>XXX.X

Patientsampleconcentrationisabove

thedynamicrange.

Seeinstructionsthatcameintheboxof

testdevicesorcontactQuidel.

<XX.X

Patientresultisbelowthedynamic

rangeorisaconcentrationbelowthe

statisticallydeterminedlowesttest

concentration.

Forsomeparameters,a0.0ng/mlpatient

resultmaybeappropriate.

BatteryLow. Batteriesneedreplacement.

Replacewith4ͲAAbatteriesorusetheAC

poweradapterasapowersource.

CannotReadBar

Code

Damagedbarcodeormeterhookmay

bebroken.(Themeterhookpullsthe

testdeviceintothemeter.)

Lookforparticlesonthebarcodeofthe

testdevice.wipeoffwithadrycloth.

Repeatthetest.

CannotRead

CodeChip.

a. CODECHIPmoduleerror.

a. • EnsureCODECHIPmoduleis

completely inserted.

 • TryareagentCODECHIPmodulefrom

adifferentboxofdevicesofthesamelot

number.

 • IfanewCODECHIPmoduleeliminates

themessage,theoriginalCODECHIP

isat

fault,discardCODECHIPmodule.

b. Metererror

b. If thenewCODECHIPmoduledoesnot

work,installaknownworkingCODE

CHIPmoduletoverifyproperoperation.

IftheCODECHIPmodulefailstowork,

contactQuidel.

DetectorFailure

OpticsDetectordidnotproperlypower

on.

Powermeteroffandwait15seconds.

Powermeteron.Ifmessagefailstoclear,

contactQuidel.

Measurement

Failure.

a. Inappropriate bodyfluidor

improperlyanticoagulatedsample.

a. Retestsampleusingnewdevicewitha

properspecimen.

b. Samplesizeincorrect–toolittle

sample.

b. Retestsampleonnewdevice.Becertain

thelowerbulbonpipetcontainsasmall

amountoffluidandtheentiretubeisfull

beforedispensingcontents.

c. Meterpickeduporcarriedvertically

whiletestisrunning.

c. Retestsampleandleavemeteronbench

topwhileperformingassay.Ifmorethan

30minutessinceinoculation,useanew

device.

d. Samplerunningslowly

d. Possibly duetocolddevicesorsample,

highhematocritwithawholeblood

sample,ormechanicalissuewithdevice.

Havecustomerimmediatelyreinsert

deviceintometer(ifwithin30minutes

ofsampleaddition).



Page79of86

Message ProbableCause CorrectiveAction

MotorFailure.

Motorceasestofunction.

• Metermaysloworstopduetoobject

lodgedontheMetertrack.



• Testdevicemaystickonthemeter

track.

Ejectandinspectthedeviceforanysticky

substances,labelsontopofthedeviceor

otheritemsthatmayinterferewith

the

meter.Ifproblempersists,contact

Quidel.

NoDeviceDatain

Memory.

ReagentCODECHIPmodulehasnotbeen

installed.

InstalltheCODECHIPmoduleincludedin

theboxoftestdevices(theReagent

CODECHIP



module).

OpticFailure.

a. Internalstandardisoutof

specification.

a. Powermeteroffthenonagain.If

OPTICFAILUREmessageclears,run

theQCDevicetoverifyproper

operation.Ifmessagefailstoclear,

contactQuidel.

b. Meterexposedtoextreme

temperatures.

b. Powermeteroff.Allowmetertositat

roomtemperaturefor1–2hours.

Powermeterbackon.

ProgramCheckOK.

PressENTERtostart

existingprogramor

pressEXITtoloada

newprogram.

MessageappearswhentheON/OFF

buttonispressedwhenthemeterhas

beenwithoutpower.

PresstheENTERkey.

QCDevice—

calibration,

alignmentorlaser

failed.

Messages:

CalibPass(orFail)

LaserPass(orFail)

AlignPass(orFail)

a. Maybeduetolintordustaffecting

reading.

a. CleanQCDevicewithalintͲfreecloth

orspraywithcannedairandrepeat

thetest.

b. QCDevicewasnotrunregularly.

b. QCDeviceshouldberunregularly

evenifpatientsamplesarenotrun.

c. Ifproblempersists,contactQuidel.

Time/Dateisblinking Metertemporarilylostallpower.

Resettimeanddateifrequired.Check

theAC/DCpowerconverterplugand

batteries.

Warning:InternalQC

OutofRange

Warningindicatesthattheinternal

qualitycontrolonthetestdevicewasout

ofrange.

Thismaybesamplespecific.

Thismaybedevicerelated.

Repeatsampleusinganewtestdevice.If

problempersists,contactQuidel.

Warning:Patient

MemoryhasSpace

for###More

Records.

Messageisdisplayedwhenmeteris

turnedonifthereisspaceleftforless

than100patientrecordsorspaceleftfor

lessthan20patientrecordswhen

runningpatientsample.

Options:

a. Printallresults.

b. Deletepatientresults.

 No actionisrequiredasthemeter

willdeletetheoldestresultoncethe

memoryisfull.



Page80of86

AppendixCReturnandDisposalProcedures

ReturnProcedure

Shouldamalfunctionoccur,contactQuidel.IfQuideldeterminesthatthemetershouldbereturned,youwill

beassignedareturnauthorizationnumberandbeprovidedshippinginstructions.



Immediatelyafterthereturnhasbeenauthorized,QuidelwillsendoutareplacementQuidelTriage

MeterPro.Returnthemalfunctioning metertoQuidel.

Notethereturnauthorizationnumberonboththe

shippingboxandtheairbillandsendthemeterbacktoQuidelassoonaspossiblefollowing receiptofthe

replacementmeter.



DisposalProcedure

Theproductmaycomeintocontactwithbloodduringtesting.Usedproductsthereforecarryariskof

infection.Whendisposingofameterthathasbeenutilized, pleasedosoinaccordancetotheregulations

applicableinyourcountry.Forinformationaboutcorrectdisposal,pleasecontactyourlocalcouncilor

authority.

TheproductfallsoutsidethescopeoftheEuropeanDirective2002/96/EC(directiveonWaste

ElectricalandElectronicEquipment(WEEE)).



AppendixDGlossary

Analyte:Chemicalsubstancebeingmeasured.

Assay:Test.



Calibration:Comparisonofresulttoareferencestandard. 

Character:Onepartofalongerstringoflettersandnumbers;forexample,inthestring"ABC",theA,B,

andCareeachacharacter.

CODECHIPModule:Anyofseveralkindsofchipsbearinginformationthatcanbedownloadedinthe



QuidelTriageMeterPro,includingReagent,QCSample,QCDevice,SupervisorandProgram.

CODECHIPModulePort:ThesmallslotontheunderneathsideoftheQuidel TriageMeterProwherea

CODECHIPmodulecanbeinserted.



Dateformats:DDͲMMͲYY:DayͲMonthͲYear

MMͲDDͲYY:MonthͲDayͲYear

YYͲMMͲDD:YearͲMonthͲDay



DeviceL/N:Lotnumberofatestdevicecanbefoundonthesideoftheboxthatcontainsthetestdevices

andoneachtestdevice.ThedeviceL/N

isafiveͲdigitnumberthatmaybeprecededbyoneormoreletters.

Themeterdisregardsallletters.

Digit:Onepartofalongernumber;forexample,inthenumber231,the2,3,and1areeachadigit.

Fluorescence:Thecharacteristicofachemicalsubstancethatenablesit

togiveofflightwhenstimulated.

NOTE:AllpartsofdatesshouldbegivenastwoͲdigitnumbers.Forexample,themonthofMayis05.

Page81of86

ID:Identification.

Immunoassay:Atestthatusesantibodiestomeasuresubstances.

InternalQC:QualitycontrolsinplaceaspartoftheQuidelTriageMeterPro’ssoftwareorzonesbuiltinto

thetestdevice.

Invitro:Madetooccurinalaboratoryvesselorothercontrolledexperimentalenvironmentratherthanin

a

livingorganism(literally,inglass).

Invitrodiagnosticuse:Foruseinacontrolledsetting.

Laserdiode:Light sourceusedintheQuidelTriageMeterPro.

LCD:Liquidcrystaldisplay;thescreenon theQuidelTriageMeterPro.Showsthemenuofpossibletestsand

proceduresandpromptstheoperatortotakethe

nextstep.

Lotnumber:L/N;identificationnumbergiventoagroupoftestdevices.

L/N:Lotnumber;thenumberthatidentifiesabatchof

testdevices.

Menu:ListofchoicesdisplayedontheQuidelTriage 

MeterPro’sscreen.

MMX:TheMultiMarkerIndexvalue,isanumber

calculatedfromthemeasured

valuesoftheanalytesin

aTestDevice.NotallQuidelTriagetestpanelshave

theMMXfeature.

Parameters:Options; functions

Photodiode:DetectsthelightemittedfromthefluorescentdyeinthetestdevicesusedintheQuidelTriage

MeterPro.

PointofCare(POC):Notinalaboratory;attheplace

wherecareisbeinggiventoapatient.

QC:QualityControl.

QCSample:Externalcontrols;aliquidsolutioncontainingchemicalsthat,whendispensedintoatest

device,reactwiththetestreagents.Usedtoverifyproperperformanceoftestdevicesaftershipmentor

longperiodsofstorage.

QCSampleCODE

CHIPmodule:CODECHIPmodulethatcanbedownloadedintotheQuidelTriage

MeterPromemorytogivethemeterinformationneededaboutthespecificlotofQCSample.

QCDevice(previouslycalledQCSimulator):

Testdevicecontaining6independentzonesthatverifiesproperoperationofthe

QuidelTriageMeterPro’sabilityto

properlyreadpatienttestsacrossvaryinganalyte

concentrations.

QCDeviceCODECHIP:CODECHIPmodulethatcanbedownloadedintotheQuidel

TriageMeterPro’smemorytogivethemeterinformationneededaboutthespecificQCDevice’s

performanceintheassignedmeter.

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Quantify,quantifying:Togivetheresultsofatestasnumber.

Reagent:Substancethatcauseschemicalreactions;usedinanalysis.

ReagentCODECHIPmodule:CODECHIP

moduleloadedwithinformationaboutaspecifictestandlot

number.

Retrieve:Find,bringback.

ReverseVideo:Lighttextdisplayedonadarkbackground.

Screen:ThepartoftheQuidelTriageMeterProthatdisplayswordsandnumbers.

Scrollto:Usearrowkeys





togototheinformationyouwant

onthescreen.

SetParameters:AfunctionoftheQuidelTriageMeterPro;requirestheuseoftheSupervisorCODECHIP

module.

SoftwareUpgradeCODECHIP:

CODECHIPmoduleusedtodownloadnewsoftwareontotheQuidelTriageMeterPro.

SupervisorCODECHIPmodule:TheCODECHIPmodulethatallowsasupervisor

toset

parametersanddeleteresults.

Testdevice:Holdsthesample(for example,blood)fromthepatientsothatitcanbeinserted

intotheQuidelTriageMeterProfortesting.Containsreagentzonesthatcausereactionsto

occurthatallowthemetertodetermineanalytelevelsinthepatient.

Testpanel:

AlternatenameforTestDevice,usuallyindicativeofaTestDevicewithmultipleanalytes.



AppendixESampleLogSheets

Thefollowinglogsheetsareprovidedasalternatemethodsoftrackingtestresults.

TheQuidelTriageMeterProiscapableoftrackingandprintingouttesthistoryandprovidingQCLockouts

topreventpatienttestingwhenoutsideQCrequirements.



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



55070–QuidelTriageMeterPro

55071–QuidelTriageMeterPro







MDSSGmBH

Schiffgraben41

30175Hannover,

Germany



QuidelCardiovascularInc.

9975SummersRidgeDrive

SanDiego,CA92121USA

quidel.com



ENSRC26611enA

PN:26611enRev.A2018/03



RevisionChanges:

InitialreleaseforQuidelCardiovascularInc.

