Abbott i-STAT 1 System Manual

14-14 Art: 714376-00M Rev. Date: 31-Jan-12
i-STAT BNP CONTROLS (LEVELS 1, 2, AND 3)
Intended Use i-STATBNPControlsareassayedliquidplasmausedtoverifytheintegrityof
newlyreceivedi-STATBNPcartridges.
Warning and
Precautions
Handletheproductsusingthesamesafetyprecautionsusedwhenhandlingany
potentially infectious material. The human plasma used in the preparation of
theseproductshasbeentestedbyFDAapprovedtestmethodsandfoundnegative/
non-reactiveforHIV-I,HIV-2,HBsAg,andHCV.However,noknowntestmethod
canoffercompleteassurancethatproductsderivedfromhumanbloodwillnot
transmit infectious disease.
Each1.0mLvialcontains<0.1%sodiumazideasapreservative.Disposeofthis
productaccordingtolocal,state,andnationalregulations.Ifdisposeddowna
drain,thesodiumazideinthisproductmayreactwithleadandcopperplumbing
toformhighlyexplosivemetalazides.Flushdrainwithlargeamountsofwater
to prevent azide build-up.
Donotuseifthecontrolsarrivethawedoruncapped.
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 Store at ≤ -18˚C(-1˚F)inanon-defrostingfreezer.Afterthawing,theopened
orunopenedvialisstablefor4hourswhencappedandstoredat2-8˚C(35-
46˚F).Donotre-freeze.
Procedure 1. Remove vial from freezer and thaw at room temperature (18-30˚C)
for 15 minutes.
2. Gently invert the vial 10 times, then swirl the vial 10 times.  Inspect
the sides of the vial to ensure that no particulate matter is clinging to
the sides of the vial. If solids are observed in the control fluid or on
the vial wall, repeat the mixing procedure.  If further mixing does not
homogenizethesample,discardthevialandthawafreshvial .
3. Open the vial and transfer a drop of solution directly from the vial
into the BNP cartridgeand seal the cartridge.  If short-term storage
(<4 hrs) is desired, tightly recap the bottle immediately after all
samplingiscomplete,andstoreat2-8˚C.
4. Insert cartridge into an 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controlsandequipmentareperformingproperly.
Shouldresultsfalloutsidetherange,refertotheTroubleshootingsectionthat
followstheProcedureforTestingControls.
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