Principles Of Operation - Abbott i-STAT Alinity Operation Manual

8

Principles of Operation

The i‑STAT Alinity instrument is an analytical, in vitro diagnostic device. The design enables it to be taken
to the patient's bedside (point of care), a convenient location near the point of care or clinical laboratory
setting. The instrument requires i‑STAT single-use cartridges containing sensors to perform quantitative
diagnostic testing. 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. 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 testing
and administrative tasks related to in vitro quantification of various analytes in a sample.
The i‑STAT Alinity instrument includes the following subsystems:
• analytical measurement module: interfaces with the i‑STAT single-use test cartridges and controls
execution of the measurement test cycle
• user module: a central computing unit with embedded firmware that controls the user interaction
with the device and supports communication with outside peripherals
• user interface: allows data input, display of information, audio and visual alerts
• rechargeable battery
Analytical 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 operations associated with the
generation of test results remain unchanged from the existing on-market i‑STAT instruments.
These fully automated dedicated microprocessor controlled operations include:
• Motion control of the fluid via mechanical actuators
• Thermal control of the sensors during the test cycle
• Acquisition 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 analytical test results
• Instrument self-tests and cartridge quality checks to prevent the delivery of an incorrect result in case
of an instrument malfunction or if a cartridge or pre-analytical error is detected
User Module
The i‑STAT Alinity instrument is equipped with a dedicated microprocessor to control user interaction
with the device, synchronization of the test cycle with the user interface, and communication. The
combination of the hardware microprocessor with peripherals and RTOS (Real Time Operating System)
offer essential features for control of the instrument.
Operations controlled by the combination of the microprocessor and RTOS include:
• low power audio processor with built-in speakers
• display and navigation of instrument screens
• networking applications
• CMOS-based area array with LED aiming and illumination barcode module:
i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022