Abbott i-STAT 1 System Manual

14-8 Art: 714376-00M Rev. Date: 31-Jan-12
Ranges
Therangesdisplayedrepresentthemaximumdeviationexpectedwhencontrols
and cartridges are performing properly.
Shouldresults outside the ranges be obtained, refertothe Troubleshooting
sectionthatfollowstheProcedureforTestingControls.
Target Values are specific to the i-STAT System. Results obtained from these
aqueouscontrolswithothermethodsmaydifferduetosamplematrixeffects.
RNA
®
MEDICAL HEMATOCRIT CONTROL
Intended Use
RNAMedicalHematocritControlisaqualitycontrolmaterialusedforverifying
the performance of hematocrit sensors in i-STAT cartridges.
Product Description
Hematocritcontrolsareprovidedinthree(3)levelsformonitoringcartridge
performanceatdifferentpoints within the clinical range. Thecontrolsare
packagedinsealedglassampules,eachcontaining1.7mLofsolution.Ampules
arepackagedten(10)perbox.
Active Ingredients
This product is a buffered aqueous solution containing electrolytes and non-
conductiveingredients.Thiscontrolcontainsnoredbloodcells,andnohuman
or biological material.
Storage
RNAMedicalHematocritControlisstableuntiltheexpirationdatestatedon
theampulewhenstoredattemperaturesof2-25°C.Donotfreezeorexpose
ampulestotemperaturesgreaterthan30ºC.
If stored refrigerated, the control material should be equilibrated to room
temperatureforatleastfour(4)hourspriortotesting.
Theproduct mayturnslightlyyellowin coloroveritsshelflifeifstoredat
room temperature. This coloration is normal and does not affect product
performance.
Directions For Use
Foreach lot ofi-STATcartridges received, usearepresentationalnumber of
cartridgestoanalyzemultiplelevelsofRNAMedicalHematocritcontrols.
1. Gently invert the ampule to mix the solution.  Tap the ampule to
restore the liquid to the bottom of the ampule.
2. Open the ampule by snapping off the tip at the neck.  Use gauze,
tissue, gloves, or an appropriate ampule opener to protect fingers
from cuts.
3. Fill and seal a cartridge and insert immediately into the analyzer.
i. Note:TheControloptionfromtheQualityTestsmenumust
beusedonthei-STAT1AnalyzerforRNAMedicalHematocrit
Control.
4. Compare the i-STAT System Hematocrit result to the value
assignment sheet value.  If the result is within the expected range,
use the cartridges as needed.
i. Iftheresultsareoutsideoftheexpectedrange,consultpage14-19
of this section for troubleshooting recommendations.

Abbott i-STAT 1 Specifications

General

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