I-Stat Alinity Reference; Complete I-Stat Alinity System Overview - Abbott i-STAT Alinity Operation Manual

1.1 - Complete i‑STAT Alinity System Overview
The i‑STAT Alinity instrument is an analytical, in vitro diagnostic device. The instrument requires i‑STAT
single-use cartridges containing electrodes and sensors to perform quantitative diagnostic testing on
whole blood or plasma. Together, the instrument and cartridge allow the user to perform clinical testing
and related administrative tasks.
The i‑STAT Alinity design enables the instrument to be taken to the patient's bedside (point of care), a
convenient location near the point of care, or clinical laboratory setting.
After the insertion of a filled test cartridge, the instrument carefully monitors and controls the testing
process. The only user intervention 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 quantitative test results within minutes.
For the purposes of this system operations manual, the i‑STAT Alinity system components and associated
accessories will be discussed. Additional information related to the entire system can be found in the
i‑STAT Alinity system documentation listed below.
Note: Note Regarding System Reliability: The i-STAT System automatically runs a
comprehensive set of quality checks of analyzer and cartridge performance each time a
sample is tested. This internal quality system will suppress results if the analyzer or
cartridge does not meet certain internal specifications (see Quality Control section in
System Operations Manual for detailed information). To minimize the probabilty of
delivering a result with medically significant error, the internal specifications are very
stringent. It is typical for the system to suppress a very small percentage of results in
normal operation given the stringency of these specifications. 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 operating conditions. Where unavailability
of results while awaiting 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 Documentation:
• i‑STAT Alinity System Operations Manual, including:
￮ i‑STAT Alinity Reference
￮ i-STAT Cartridge Instructions for Use
￮ AlinIQ NCi - Network Connectivity for i‑STAT Alinity
￮ AlinIQ CWi - Customization Workspace for i‑STAT Alinity
• i‑STAT Alinity Quick Reference Guide
• i‑STAT Alinity Getting Started Guides:
￮ i‑STAT Alinity Base Station
￮ i‑STAT Alinity Rechargeable Battery
￮ i‑STAT Alinity Electronic Simulator
￮ i‑STAT Alinity Printer
i-STAT Alinity — System Operations Manual Art: 745526-01 Rev. H
3
Rev. Date: 04-Mar-2021