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

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

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 [e-mail]
LatinAmerica +57.2.6618797 [email protected]
Canada +1.613.271.1144 [email protected]
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MainMenuStructure
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
RunTest RecallResults 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Results
x QCDeviceResults
x Reagent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 DeleteUserID
x UserIDList
x QCDeviceFreq.
x QCSampleFreq.
x NumberofControls
x NumQuant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 BaudRat e
x Pat.ResultApproval
x LISEnable/Disable
x AutoUpload
x Language
x PrintMode
x AutoPowerͲOff
x DisplayContrast
x PrinterContrast
*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equipment(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MeterPro.Themetermeasureshowmuchofthesubstance(aparticularprotein
marker)ispresent,basedonstandardsthathavebeenpreͲprogrammed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
1Ͳ16

CHARACTERSPAT.IDMin1
Max20
1Ͳ20
1Ͳ20

CHARACTERSAUXIDMin1
Max12
1Ͳ12
1Ͳ12

CHARACTERSMISCID

Min1
Max20
1Ͳ20
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Settings.
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.
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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.