Art: 714376-00M Rev. Date: 31-Jan-12 14-11
Control solutions may also be stored at room temperature for up to 4 hours (18
to30°Cor64to
-
86°F).Ifleftoutlongerthan4hoursatroomtemperature,
they should be discarded.
Directions for Use
Prior to testing, vials containing the lyophilized plasma and CaCl
2
reconstitutingfluidshouldstandatroomtemperature18-30ºC(64-86ºF)fora
minimumof45minutes.Forbestresults,vials,cartridges,andanalyzersshould
be at the same temperature.
Reconstituteonlyonelevelofcontrolplasmaatatime.CONTROLSOLUTIONS
MUST BE USED IMMEDIATELY (less than 30 seconds) AFTER COMPLETING
THERECONSTITUTIONANDMIXINGSTEPS.
STEP ACTION
1 After45minuteroomtemperatureequilibration,removethecap
and stopper from one lyophilized human plasma control vial and
remove the cap from one vial of calcium chloride reconstituting
fluid.
2 Pour the entire contents of the calcium chloride vial into the
lyophilized human plasma control vial. Place the stopper back
inthereconstitutedcontrolvial,sealingthevialappropriatelyso
that the contents do not leak or spill out.
3 Allowthevialtositatroomtemperaturefor1minute.
4 Mix the contents of the vial by swirling gently
for1minute,theninvertingslowlyfor30seconds.
Note:Tominimizefoamingofthecontrolsample,avoidvigorous
orrapidmixingmotion.Visuallyinspectthecontrolvialtoensure
thatthesampleisfullyreconstituted.Ifnot,discardandstart
overwithfreshvials.
5 Usinga plastic transfer pipette, plastic syringe, or plastic
capillarytubewithnoanticoagulant,immediatelytransferthe
solutionfromthevialintothePT/INRcartridge.
6 Immediately seal the cartridge and insert it into an analyzer.
Note: Additional PT/INR cartridges may be tested with
the remaining fluid if used within 30 seconds of complete
reconstitution of the sample.
Handle this product using the same safety precautions used when handling
any potentially infectious material. The human plasma used in the
preparation of this product has been tested by FDA approved test methods and
foundnegative/non-reactiveforHIV-1,HIV-2,HBsAg,andHCV.However,no
known test method can offer complete assurance that products derived from
humanbloodwillnottransmitinfectiousdisease.
Disposeofthisproductasbiohazardouswasteaccordingtoalllocal,state,and
national regulations.
Warnings and
Precautions
Control Target Values
and Expected Ranges
Target values (determined by testing multiple vials of each level using multiple
lotsofi-STATcartridgeswithanalyzersthathavepassedtheElectronicSimulator
test)areprintedonavalueassignmentsheetpostedontheAPOCwebsiteat
www.abbottpointofcare.com.Therangesdisplayedrepresentthemaximum
deviation expected when controls and cartridges are performing properly.
Should results outside the range be obtained, refer to the Troubleshooting
portionofthissectionofthei-STATSystemManual.Alwaysbesurethatthelot
number printed on the value assignment sheet matches the lot number on the
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