![background image](http://html1.mh-extra.com/html/abbott/i-stat-alinity/i-stat-alinity_operation-manual_3045656046.webp)
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:
8
i-STAT Alinity — System Operations Manual
Art: 745527-01 Rev. N
Rev. Date: 13-Oct-2022
Summary of Contents for i-STAT Alinity
Page 1: ......
Page 12: ...xii i STAT Alinity System Operations Manual Art 746982 01 Rev E Rev Date 02 Nov 2022 ...
Page 24: ...xxiv i STAT Alinity System Operations Manual Art 746983 01 Rev H Rev Date 11 Nov 2020 ...
Page 39: ......
Page 44: ...6 i STAT Alinity System Operations Manual Art 745526 01 Rev H Rev Date 04 Mar 2021 ...
Page 48: ...10 i STAT Alinity System Operations Manual Art 745527 01 Rev N Rev Date 13 Oct 2022 ...
Page 84: ...46 i STAT Alinity System Operations Manual Art 745531 01 Rev G Rev Date 04 Mar 2021 ...
Page 88: ...50 i STAT Alinity System Operations Manual Art 745529 01 Rev G Rev Date 04 Mar 2021 ...
Page 96: ...58 i STAT Alinity System Operations Manual Art 745530 01 Rev D Rev Date 16 May 2022 ...
Page 100: ...62 i STAT Alinity System Operations Manual Art 745578 01 Rev C Rev Date 04 Mar 2021 ...
Page 108: ...70 i STAT Alinity System Operations Manual Art 745525 01 Rev E Rev Date 04 Mar 2021 ...
Page 110: ...72 i STAT Alinity System Operations Manual Art 745532 01 Rev D Rev Date 04 Mar 2021 ...
Page 134: ...96 i STAT Alinity System Operations Manual Art 745524 01 Rev I Rev Date 02 Nov 2022 ...
Page 147: ......
Page 164: ...126 i STAT Alinity System Operations Manual Art 747079 01 Rev F Rev Date 28 Apr 2020 ...
Page 167: ......
Page 176: ...136 i STAT Alinity System Operations Manual Art 746298 01 Rev M Rev Date 13 Oct 2022 ...
Page 250: ...210 i STAT Alinity System Operations Manual Art 746300 01 Rev N Rev Date 02 Nov 2022 ...
Page 290: ...250 i STAT Alinity System Operations Manual Art 746300 01 Rev N Rev Date 02 Nov 2022 ...
Page 296: ...256 i STAT Alinity System Operations Manual Art 746304 01 Rev H Rev Date 29 Oct 2019 ...