Abbott i-STAT 1 System Manual

Art: 714376-00M Rev. Date: 31-Jan-12 14-9
CONTROLS FOR ACT CARTRIDGES
Intended Use
The i-STAT
®
ACT Control Level 1 and ACT Control Level 2 are intended for use
toverifytheintegrityofnewlyreceivedi-STATACTcartridges.Thecontrols
produceclottingtimesexpectedformoderateandhighlevelheparinization
to indicate that the cartridges are functioning properly.
Contents
Eachlevelofcontrolispackagedasaboxof5vialsoflyophilizedhumanplasma
and5vialsof9.5
±
1.5mmol/Lcalciumchloridediluent.
Storage
i-STAT ACTcontrols,Levels1 and2,are containedin6-mLvials. Separate
6-mL vials contain 1-3 mL of calcium chloride solution for reconstitution.
Refrigeratedstorageat2to8ºC(35to46ºF)shouldbemaintaineduntilthe
printedexpirationdateontheboxandviallabels.Donotusebeyondthe
expirationdateontheboxandviallabels.
Control solutions may also be stored at room temperature for up to 4 hours (18
to30°Cor64to
-
86°F).Ifleftoutlongerthan4hoursatroomtemperature,
they should be discarded.
Warnings and
Precautions
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
foundnegative/non-reactiveforHIV-1,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.
Disposeofthisproductasbiohazardouswasteaccordingtoalllocal,state,and
national regulations.
Directions for Use
Priortotesting,vialscontainingthelyophilizedplasmaandCaCl
2
reconstituting
uidshouldstandatroomtemperature(18-30ºCor64-86ºF)foraminimum
of45minutes.Forbestresults,vials,cartridges,andanalyzersshouldbeatthe
same temperature.
Reconstituteonlyonelevelofcontrolplasmaatatime.CONTROLSOLUTIONS
MUSTBEUSEDIMMEDIATELY(lessthan30seconds)AFTERCOMPLETING
THERECONSTITUTIONANDMIXINGSTEPS.
ii. Note:thisproductisabufferedaqueoussolutioncontaining
electrolytes and non-conductive ingredients. The only value
assigned to this fluid is for hematocrit. All other cartridge analyte
resultsobtainedwiththiscontrolmaterialshouldbeignored.
5. Ifavailable,transmitresultstotheCentralDataStation.

Abbott i-STAT 1 Specifications

General

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