To Next Page

To Previous Page

i-STAT ACT Controls

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 clong mes expected for moderate and

high level heparinizaon to indicate that the cartridges are funconing properly.

Storage

i-STAT ACT controls contain two levels, Level l and Level 2. ACT controls consist of two vials for each level

of control. One vial contains lyophilized plasma and the other vial contains the diluent (calcium chloride

soluon). One box contains 5 vials of lyophilized plasma and 5 vials of diluent. Lyophilized plasma and

the diluent should be refrigerated at 2 to 8°C (35 to 46°F) unl the expiraon date printed on the box

and vial labels. Do not use beyond the expiraon date.

Warnings and Precauons

Handle this product using the same safety precauons used when handling any potenally infecous

material. The human plasma used in the preparaon of this product has been tested by FDA-approved

test methods and found negave/non-reacve for HIV-1, HIV-2, HBsAg, and HCV. However, no known

test method can oer complete assurance that products derived from human blood will not transmit

infecous disease.

Ranges

Assigned ranges are found on i‑STAT Value Assignment Sheets (VAS) located on hps://

www.globalpointofcare.abbo/en/support/istat-brand/vas-i-stat-alinity.html. Follow facility policy

regarding control results that do not fall within assigned ranges.

Disposal

Dispose of this product as biohazardous waste according to all local, state, and naonal regulaons.

Reconstuon Instrucons

Prior to tesng, i‑STAT ACT Control vials containing the lyophilized plasma and diluent should stand at

room temperature (18° to 30°C or 64° to 86°F) for a minimum of 45 minutes.

Note: Vials le out a

t room temperature for more than 4 hours should be discarded.

Pour the enre contents of the diluent into the lyophilized plasma vial. See further instrucons under

Procedure for Tesng

Prerequisites

• Vials, cartridges, and instruments must be at the same temperature.

• i‑STAT ACT Control vials containing the lyophilized plasma and diluent should stand at room

temperature (18 to 30°С or 64 to 86°F) for a minimum of 45 minutes.

• i‑STAT ACT Control tesng must be performed IMMEDIATELY (less than 30 seconds) AFTER

COMPLETING THE RECONSTITUTION AND MIXING STEPS.

i-STAT Alinity — System Operaons Manual Art: 745533-01 Rev. H Rev. Date: 02-Nov-2022

Abbott i-STAT Alinity User Manual

Other manuals for Abbott i-STAT Alinity