Abbott i-STAT 1 System Manual

14-12 Art: 714376-00M Rev. Date: 31-Jan-12
CONTROLS FOR cTnI CARTRIDGES
i-STAT
®
Cardiac Markers Controls are assayed human sera used to verify the
integrityofnewlyreceivedi-STATcTnIcartridges.
Handlethisproductusingthesamesafetyprecautionsusedwhenhandlingany
potentially infectious material. The human sera used in the preparation of this
producthavebeentestedbyFDAapprovedtestmethodsandfoundnegative/
non-reactiveforHIV-1,HIV-2,HBsAg,HCV,HTLV-1andHTLV-2.However,no
knowntestmethodcanoffercompleteassurancethatproductsderivedfrom
humanbloodwillnottransmitinfectiousdisease.
Eachvialcontains<0.1%sodiumazideasapreservative.Disposeofthisproduct
accordingtoall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 can cause an increase in turbidity. Do not use the
controlifthereisvisibleevidenceofmicrobialgrowthorgrosscontamination.
Storage and Stability
Store at ≤ –18
o
C (-1
o
F)inanon-defrostingfreezer.Afterthaw,theopenedor
unopenedvialisstablefor4hourswhencappedandstoredat2-8
o
C (35-46
o
F).Donotre-freeze.
Procedure
Step Action
1 Remove vial from freezer and thaw at room temperature (18-30°C) for 15 minutes.
2 Thoroughly mix by gently swirling the bottle. Avoid foaming of the sample.
3 Dispense a drop of sample directly from vial into the i-STAT cTnI cartridge and seal the
cartridge. Tightly recap the bottle immediately after all sampling is complete and store
at 2-8°C.
4 Insert cartridge into an i-STAT analyzer.
labelofthevialinuse,andthatthesoftwarerevisionabovethetablematches
thesoftwarerevisionintheanalyzer(checkthestatuspageontheanalyzer).
Note: Target values are specific to the i-STAT System; results obtained from these
reconstitutedcontrolplasmasmaydifferifusedwithothermethods.
Warnings and
Precautions
Control 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.
Intended Use

Abbott i-STAT 1 Specifications

General

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