11/4/2016

CoaguChekProII

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CoaguChek systems
The smart way to test INR at the Point of Need

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CoaguChek Pro II
Expanding coagulation testing in theHospital Point of Care
setting

TheCoaguChekProIICoagulationMeterfeaturesmultipleenhancementstothe
previousgenerationofCoaguChekdevices(CoaguChekXSPlusandCoaguChekXS
Pro).Itbringsthelabclosertothepatientinthehospitalenvironment.In
addition,itcontinuestosupportVitaminKAntagonist(VKA)therapymonitoringin
theprofessionalsegments,suchasanticoagulation(AC)clinicsanddoctor'soffices.
TwoassayscanbedeterminedwiththenewCoaguChekProIImeter
ProthrombinTime(PT)(withextendedclaims),aswellasActivatedPartial
ThromboplastinTime(aPTT).

The CoaguChek Pro II meter features

2Dbarcodereaderforpatient,operatorandcontrolsidentificationforfasterID
entry
Universalbatterypack,chargingviapoweradapterand/orBaseUnit*(HBU)
Enhancedconnectivitythroughwirelesstechnologyand/ortheuniqueQRcode
feature
PT/INRresultsinapproximately1minute
aPTTresultsinlessthan5minutes
Sideandtopdosingoptionswithadropofvenous,capillaryorarterialfresh
wholeblood(min.8L)

Clinically Vital
FromthefloorstotheORtotheERtotheICU,aPTTandPTresultsareinyourhandsinrealtime

Enhanced Connectivity
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Criticalinformationisavailablewhenandwhereitisneededmost
Wirelessconnectivityandbarcodereaderfordigitalinputandoutput
QRcodefeatureenablesdatatransmissiontoanydatamanagementsystemimmediately,withnoneedtotranscriberesultsforastreamlinedworkflow

SystemcomponentsTechnicalSpecifications

Get immediately actionable results

at ALL points of care

System components

TheCoaguChekProIIinstrumentkitcontains:
1CoaguChekProIIinstrument
1handheldpowersupplyunit
1usermanualinEnglish
1CDROMwithotherlanguages:German,French,Italian,English,Spanish,Portuguese,Danish,
Norwegian,Swedish,FinnishandDutch
Optionalaccessories

Handheldbaseunitkit:dockingstation(torechargethebatterypackandtransferdatatoa
computer)
Additionalrequiredcomponents
CoaguChekPTTeststrips

CoaguChekPTControls

CoaguChekaPTTControls

Boxwith2vialsof24stripswithacodechip

4vialsoflevel1control
4vialsoflevel2control

4vialsoflevel1control
4vialsoflevel2control

CoaguChekaPTTTeststrips

8diluentfilleddroppers
1codechip

8diluentfilleddroppers
1codechip

Boxwith2vialsof24stripswithacodechip

Technical specifications

Measuring&Sampling
Detectionsystem
PT:Amperometric(electrochemical)determinationafteractivationofthebloodcoagulationwithhumanrecombinantthromboplastin

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aPTT:Amperometric(electrochemical)determinationafteractivationofbloodcoagulationwithcelite

Userinterface
Fullgraphical(TFT)
Supportandsafetyfunctions
QClockout,Patient&UserID,protectionwithadministratorID.2DBarcodeScanner
Sampleapplication
Outsidethemeter,withtopand2sides(leftorright)dosingoptions
OperatingConditions
OperatingTemperature
+12Cto+32C(54Fto90F)
Operatinghumidityandaltitude
1085%4300m(14,000ft)
Handling
Operatethemeteronalevel,vibrationfreesurface,orholditsothatitisroughlyhorizontal.
Measuringrange
PT/INR:0.88.0%Q:1205SEC:9.696
aPTT:20130plasmaequivalentseconds
Memory
2000patientand500QCresultswithdateandtime.
120codechiprecords(60stripcode&60controlcodes)
Operatorlistwithupto5000OperatorIDswithcorresponding2ndID.e.g.operatorname
Patientlistwithupto4000PatientIDswithcorresponding2ndand3rdpatientIDs.e.gname,dateofbirth

Interface
Touchscreenandbarcodescanner
Poweroptions
UniversalbatterypackfortheCoaguChekProII
Powersupplyadapter:input:100240V/5060Hz/350150mAoutput:12VDC/1.25A

Numberoftestsw/fullychargedbatterypack
Approx.60testsPT/INR
Atleast20testsaPTT/measuringtime5minutes
Dimensions
187x97x43mm
Weight
280g(withoutbatteries)
SafetyClass
III
Autopoweroff
Programmable1to60minutes
SampleMaterial
Sampletype
Capillary,venous,orarterialfreshwholeblood
Samplesize
8l
Interferences
Refertotheteststrippackageinsert
TestStrips
ISI
Approx.1.0
Sensitivitytoheparin
PT/INR:Insensitivetounfractionatedandfractionatedheparinconcentrationsupto3IU/mLblood
aPTT:Insensitivetolowmolecularweightheparins(LMWH)upto0.5IU/mLblood

Qualitycontrol
Oneachstrip,throughthesamechannelasthebloodpasses

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Stability
Storeat+2Cto+30C.Teststripscanbeuseduntilexpirydateprintedontheboxandteststripvial.

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