Abbott i-STAT 1 System Manual

Art: 714376-00M Rev. Date: 31-Jan-12 14-13
CLINIQA LIQUID QC™ CARDIAC MARKER CONTROLS FOR i-STAT
Intended Use
CLINIQALiquid QC™ Cardiac Marker Controlsare assayed human plasma
which can be used to verify the integrity of newly received i-STAT CK-MB
cartridges.CLINIQALiquidQCCardiacMarkerControlsarenotintendedto
be used as a standard.
Warning and
Precautions
Eachserum/plasmadonorunitusedinthemanufactureofthisproducthas
beentestedbyFDAacceptedmethodsandfoundnegative/non-reactiveforthe
presenceofHBsAgandtheantibodytoHIV-1/2,HCV,andHIV-1Ag.While
thesetestmethodsarehighlyaccurate,theydonotguaranteethatallinfected
units will be detected.  Because no known test method can offer complete
assurancethehepatitisBvirus,hepatitisCvirus,humanimmunodeciency
virus(HIV)orotherinfectiousagentsareabsent,allproductscontaininghuman
sourcematerialshouldbeconsideredpotentiallyinfectiousandhandledwith
thesameprecautionsusedwithpatientspecimens.
Bacterial contamination of the control can cause an increase in turbidity. Do
notusethecontrolmaterialifthereisvisibleevidenceofmicrobialgrowthor
gross contamination.
Storage and Stability
CLINIQALiquidQCCardiacMarkerControlisaready-to-useliquidcontrol
requiringnoreconstitutionorfrozenstorage.Itisstableuntiltheexpiration
dateontheviallabelwhenstoredunopenedat2-8°C.Onceopened,CLINIQA
LiquidQCCardiacMarkerControlisstablefor30dayswhenstoredtightly
capped at 2-8°C.
Procedure
1. Access the i-STAT Cartridge Control option under Quality Tests in the
Administration Menu.  Enter the required information.  The analyzer
allows 15 minutes (or the customized timeout period) to insert the
cartridge after the last data entry.
2. Immediately before use, gently mix the contents of the control vial to
ensure homogeneity. Avoid foaming of the sample.
3. Openthevialandtransferadropofthesolutionintothei-STATCK-MB
cartridge using a plain capillary tube, plain syringe, or plastic transfer
pipette. Tightly recap the control vial and store it at 2-8°C.
4. Seal the cartridge and immediately insert it into the i-STAT 1 Analyzer.
Target Values and
Ranges
See value assignment sheet posted on the APOC website at www.
abbottpointofcare.com. The value assignment sheet displays target values
andrangesexpectedwhenmaterialsandequipmentareperformingproperly.
Shouldresults fall outside the range,consult page 14-19 of thissection for
troubleshooting recommendations.
Always ensure that the lot number and software revision on the value
assignmentsheetmatchesthelotnumberofthevialinuseandthesoftware
revision in the analyzer.
Targetvaluesarespecictothei-STATSystem.Resultsmaydifferifusedwith
other methods.

Abbott i-STAT 1 Specifications

General

Brand	Abbott
Model	i-STAT 1
Category	Measuring Instruments
Language	English