Abbott i-STAT Alinity - 1.1 - Complete i-STAT Alinity System Overview; 1.3 - i-STAT Alinity Results Screen

1.1 - Complete i‑STAT Alinity System Overview
The i‑STAT Alinity instrument is an analycal, in vitro diagnosc device. The instrument requires i‑STAT
single-use cartridges containing electrodes and sensors to perform quantave diagnosc tesng on
whole blood or plasma. Together, the instrument and cartridge allow the user to perform clinical tesng
and related administrave tasks.
The i‑STAT Alinity design enables the instrument to be taken to the paent’s bedside (point of care), a
convenient locaon near the point of care, or clinical laboratory seng.
Aer the inseron of a lled test cartridge, the instrument carefully monitors and controls the tesng
process. The only user intervenon is in the form of data entry, performed via the touchscreen or by
barcode capture. Throughout the cycle, the instrument performs a series of quality checks. These checks
are designed to monitor the status of the instrument and the quality of the cartridge. An i‑STAT Alinity
instrument, a cartridge with the required test, and two or three drops of blood will allow the caregiver to
view quantave test results within minutes.
For the purposes of this system operaons manual, the i‑STAT Alinity system components and associated
accessories will be discussed. Addional informaon related to the enre system can be found in the
i‑STAT Alinity system documentaon listed below.
Note: Note Regarding System Reliability: The i-STAT System automacally runs a
comprehensive set of quality checks of analyzer and cartridge performance each me a
sample is tested. This internal quality system will suppress results if the analyzer or
cartridge does not meet certain internal specicaons (see Quality Control secon in
System Operaons Manual for detailed informaon). To minimize the probabilty of
delivering a result with medically signicant error, the internal specicaons are very
stringent. It is typical for the system to suppress a very small percentage of results in
normal operaon given the stringency of these specicaons. If however, the analyzer or
cartridges have been compromised, results may be persistently suppressed, and one or
the other must be replaced to restore normal operang condions. Where unavailability
of results while awaing replacement of analyzers or cartridges is unacceptable, APOC
recommends maintaining both a back up i-STAT System instrument and cartridges from
an alternate lot number.
i
‑STAT Alinity Documentaon:
• i‑STAT Alinity System Operaons Manual, including:
￮ i‑STAT Alinity Reference
￮ i-STAT Cartridge Instrucons for Use
￮ AlinIQ NCi - Network Connecvity for i‑STAT Alinity
￮ AlinIQ CWi - Customizaon Workspace for i‑STAT Alinity
• i‑STAT Alinity Quick Reference Guide
• i‑STAT Alinity Geng Started Guides:
￮ i‑STAT Alinity Base Staon
￮ i‑STAT Alinity Rechargeable Baery
￮ i‑STAT Alinity Electronic Simulator
￮ i‑STAT Alinity Printer
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i-STAT Alinity — System Operaons Manual Art: 745526-01 Rev. H Rev. Date: 04-Mar-2021