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1.10 - Liquid Quality Controls

Perform liquid quality control tesng in accordance with facility protocols, best pracces, and regulatory

requirements.

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 secon of this manual for

instrucon on creang and assigning customizaon proles to instruments.

i-STAT Controls and i-STAT TriControls

Aqueous-based control soluons 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 dened pH values

and hematocrit values (TriControls only) and with known concentraons of:

Sodium PCO

Glucose

Potassium PO

Lactate

Chloride TCO

BUN/Urea

Ionized Calcium Creanine

Each level of control is packaged in a box containing 10 individual 1.7 mL glass ampules.

The c

ontrol soluons do not contain human serum or serum products, but they do contain buers and

preservaves.

Storage

Store refrigerated at 2 to 8ºC (35 to 46ºF) unl the printed expiraon date on the box and ampule labels.

Unopened ampules of control soluons can also be maintained at room temperature (18 to 30ºC or 64

to 86ºF) for up to 5 days.

Do not use control soluons past the labeled expiraon date on the box and ampule labels.

Ampule use

Barcode on the ampule must be scanned before the ampule is opened.

Tesng must be performed within 10 minutes of opening the ampule.

Tesng must be performed immediately upon opening when tesng pH, PCO

, PO

or iCa.

Ranges

Assigned ranges are provided in the form of value assignment sheets (VAS). These are located on hps://

www.globalpointofcare.abbo/en/support/istat-brand/istat-alinity.html. Abbo 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 Operaons Manual Art: 745533-01 Rev. H Rev. Date: 02-Nov-2022

Abbott i-STAT Alinity User Manual

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