i-STAT Alinity v — User Manual 650-7100 Rev. A12
Intended Use
The i-STAT Alinity v Analyzer is an analytical, point of care device designed for
veterinary use only.
The i-STAT Alinity v Analyzer with i-STAT test cartridges is intended for use in
point of care or clinical laboratory settings. The i-STAT Alinity system is intended
for the quantitative measurement of various analytes in arterial, venous and
capillary whole blood.
Principles of Operation
The design enables it to be taken to a convenient location near the point of care.
The analyzer requires i-STAT single-use cartridges containing sensors to perform
quantitative diagnostic testing on whole blood. After the insertion of a filled test
cartridge, the analyzer 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 analyzer performs
a series of quality checks. These checks are designed to monitor the status of the
analyzer and the quality of the cartridge. The analyzer and cartridge together
allow the user to perform clinical testing and administrative tasks related to the
quantification of various analytes in a whole blood sample.
The i-STAT Alinity v Analyzer 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
Precautions and Limitations
For best results, observe the following precautions to prevent damage to the
i-STAT Alinity v Analyzer and its peripherals, to ensure the safety of the operator
and the integrity of the results.
DO:
• Only use Abaxis supplied accessories, power supplies, power cables, and
consumables specified for the i-STAT Alinity system (includes analyzer, printer
and base station).
• Always use the Base Station for charging the i-STAT Alinity v
Analyzer.
• Connect only the i-STAT Alinity printer to the Base Station
printer port.
• Always place the Analyzer, Base Station, and Printer on a level and stable
surface or in a location where they will not cause injury if dropped.
• Falling equipment may cause injury.
System Components (Continued)