Liquid Quality Controls; I-Stat Controls And I-Stat Tricontrols - Abbott i-STAT Alinity Operation Manual

Perform liquid quality control testing in accordance with facility protocols, best practices, and regulatory
requirements.

i-STAT Controls and i-STAT TriControls

Aqueous-based control solutions are available for verifying the integrity of newly received cartridges.
i‑STAT Control Level 1, 2 and 3 are formulated at three clinically relevant levels with defined pH values
and hematocrit values (TriControls only) and with known concentrations of:
Sodium
Potassium
Chloride
Ionized Calcium
Each level of control is packaged in a box containing 10 individual 1.7 mL glass ampules.
The control solutions do not contain human serum or serum products, but they do contain buffers and
preservatives.
Storage
Store refrigerated at 2 to 8ºC (35 to 46ºF) until the printed expiration date on the box and ampule labels.
Unopened ampules of control solutions can also be maintained at room temperature (18 to 30ºC or 64
to 86ºF) for up to 5 days.
Do not use control solutions past the labeled expiration date on the box and ampule labels.
Ampule use
Barcode on the ampule must be scanned before the ampule is opened.
Testing must be performed within 10 minutes of opening the ampule.
Testing must be performed immediately upon opening when testing pH, PCO
Ranges
Assigned ranges are provided in the form of value assignment sheets (VAS). These are located on
www.globalpointofcare.abbott/en/support/istat-brand/istat-alinity.html. Abbott Point of Care makes
available both eVAS and ReVAS. ReVAS ranges are provided as a feature for the German market and for
those customers who prefer ranges set using Rilibak guidelines.
i-STAT Alinity — System Operations Manual

1.10 - Liquid Quality Controls

Note: Only i‑STAT Controls, i‑STAT TriControls Controls and i-STAT ACT Controls can be
used with a non-customized instrument. See the AlinIQ CWi section of this manual for
instruction on creating and assigning customization profiles to instruments.
PCO
2
PO
2
TCO
2
Glucose
Lactate
BUN/Urea
Creatinine
Art: 745533-01 Rev. H
, PO or iCa.
2 2
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Rev. Date: 02-Nov-2022
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