Abbott i-STAT Alinity - Principles of Operation

Principles of Operaon
The i‑STAT Alinity instrument is an analycal, in vitro diagnosc device. The design enables it 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. The instrument requires i‑STAT single-use cartridges containing sensors to perform quantave
diagnosc tes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. Data entry is
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. The instrument and cartridge together allow the user to perform clinical tesng
and administrave tasks related to in vitro quancaon of various analytes in a sample.
The i‑STAT Alinity instrument includes the following subsystems:
• analycal measurement module: interfaces with the i‑STAT single-use test cartridges and controls
execuon of the measurement test cycle
• user module: a central compung unit with embedded rmware that controls the user interacon
with the device and supports communicaon with outside peripherals
• user interface: allows data input, display of informaon, audio and visual alerts
• rechargeable baery
Analycal Measurement Module
The core measurement technology of the i‑STAT Alinity system is in the micro-fabricated electro-
chemical sensors located in the i‑STAT single-use disposable cartridges. As a result, the measurement
technology used by the instrument and the principles governing operaons associated with the
generaon of test results remain unchanged from the exisng on-market i‑STAT instruments.
These fully automated dedicated microprocessor controlled operaons include:
• Moon control of the uid via mechanical actuators
• Thermal control of the sensors during the test cycle
• Acquision of sensor electrical signals (voltage, current or resistance) throughout the test cycle, as
well as environmental parameters like temperature and pressure
• Timing and sequence of measurement events
• Signal processing and conversion of sensor and environmental signals into analycal test results
• Instrument self-tests and cartridge quality checks to prevent the delivery of an incorrect result in case
of an instrument malfuncon or if a cartridge or pre-analycal error is detected
User Module
The i‑STAT Alinity instrument is equipped with a dedicated microprocessor to control user interacon
with the device, synchronizaon of the test cycle with the user interface, and communicaon. The
combinaon of the hardware microprocessor with peripherals and RTOS (Real Time Operang System)
oer essenal features for control of the instrument.
Operaons controlled by the combinaon of the microprocessor and RTOS include:
• low power audio processor with built-in speakers
• display and navigaon of instrument screens
• networking applicaons
• CMOS-based area array with LED aiming and illuminaon barcode module:
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i-STAT Alinity — System Operaons Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022