Unit-Use Cartridge; Handheld Analyzer And Blood Analysis Module - Abbott i-STAT 1 System Manual

Unit-Use Cartridge

Handheld Analyzer
and Blood Analysis
Module
Art: 714382-00D
Verification
Microfabricated Electrochemical Sensor Elements
• verify sensors are present
• verify sensor characteristics are consistent with expectations
of a properly manufactured and maintained device (by testing
calibration fluid)
Calibration Fluid
• verify fluid is present
• verify fluid is delivered free of bubbles
• verify fluid has proper concentration
Fluidic System
• verify sample holding chamber is sealed
• verify fluid flowpaths are intact (no part of the analyzer or
module comes into direct contact with fluid)
• verify waste chamber is not occluded
Elements that interact with the handheld analyzer or Blood Analysis
Module
• verify electrical contact pads (that allow access to sensor
signals) are unoccluded
• verify internal element of cartridge that allows the analyzer
or module to control the release of calibration fluid over the
sensors is functioning properly
• verify internal element of cartridge that allows the analyzer
or module to control the replacement of calibration fluid with
sample is functioning properly
Verification
Motorized Mechanical System
• verify electrical contact is made with sensors on cartridge
• verify ability to properly move calibration fluid
• verify ability to properly move sample
Electrical Measurement System
• verify voltage measuring system for potentiometric sensors
• verify current measuring system for amperometric sensors
• verify resistance measuring system for conductometric sensors
Other
• verify internal self-consistency of electronic systems
• verify fluid flow using the conductivity sensor
• verify function of transducers used for measuring barometric
pressure
• verify function of the thermistors used to control chip
temperature
Rev. Date: 02/20/06
When Verified
Every cartridge use
Every cartridge use
Every cartridge use
Every cartridge use
Every cartridge use
Every cartridge use
Every cartridge use
Every cartridge use
Every cartridge use
Every cartridge use
Every cartridge use
When Verified
Every cartridge use
Every cartridge use
Every cartridge use
Electronic Simulator
Electronic Simulator
Electronic Simulator
Every cartridge use
Every cartridge use
Every cartridge use
Electronic Simulator
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