Quidel Triage MeterPro - Appendix C Return and Disposal Procedures; Return Procedure; Disposal Procedure; Appendix D Glossary

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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)).
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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.