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
fluid 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.
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