Art: 714382-00D
Rev. Date: 02/20/06
20-11
Unit-Use Cartridge
Verification
When Verified
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)
Every cartridge use
Every cartridge use
Calibration Fluid
• verify fluid is present
• verify fluid is delivered free of bubbles
• verify fluid has proper concentration
Every cartridge use
Every cartridge use
Every cartridge use
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
Every cartridge use
Every cartridge use
Every cartridge use
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
Every cartridge use
Every cartridge use
Every cartridge use
Handheld Analyzer
and Blood Analysis
Module
Verification
When Verified
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
Every cartridge use
Every cartridge use
Every cartridge use
Electrical Measurement System
• verify voltage measuring system for potentiometric sensors
• verify current measuring system for amperometric sensors
• verify resistance measuring system for conductometric sensors
Electronic Simulator
Electronic Simulator
Electronic Simulator
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
Every cartridge use
Every cartridge use
Every cartridge use
Electronic Simulator
Summary of Contents for i-STAT 1
Page 1: ...i STAT 1 System Manual Rev Date 20 Jan 12 Art 714336 00L ...
Page 18: ...1 8 Art 714363 00U Rev Date 02 Aug 12 ...
Page 44: ......
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Page 106: ...9 12 Art 714371 00E Rev Date 06 Aug 12 ...
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Page 166: ...Art 730292 00A Rev Date 20 Feb 12 4 ...
Page 176: ...10 10 Art 714372 00L Rev Date 30 Jul 12 ...
Page 182: ...11 6 Art 714373 00F Rev Date 17 Jan 11 ...
Page 184: ...12 2 Art 714374 00J Rev Date 25 Aug 11 ...
Page 185: ...Art 714374 00J Rev Date 25 Aug 11 12 3 ...
Page 186: ...12 4 Art 714374 00J Rev Date 25 Aug 11 ...
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Page 214: ...14 20 Art 714376 00M Rev Date 31 Jan 12 ...
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Page 294: ...Art 725768 00E Rev Date 04 Jan 12 20 ...
Page 336: ...22 2 Art 714384 00D Rev Date 07 18 06 ...
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Page 488: ...Kaolin ACT 4 Art 715878 00M Rev Date 31 Jan 12 ...
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Page 556: ...Art 714261 00E Rev Date 10 Jan 11 8 ...
Page 560: ...Art 716240 00D Rev Date 03 Mar 10 4 ...
Page 572: ...Art 715617 00D Rev Date 06 11 08 ...
Page 578: ...Art 714547 00F Rev Date 06 11 08 ...
Page 590: ...Art 720735 00B Rev Date 06 11 08 ...
Page 592: ...Art 721106 00B Rev Date 06 11 08 ...
Page 598: ...Art 722831 00A Rev Date 19 Feb 09 ...
Page 610: ...Art 720654 00B Rev Date 06 11 08 ...
Page 614: ...Art 721317 00D Rev Date 13 Aug 12 4 ...
Page 616: ...Art 725703 00A Rev Date 08 Mar 10 2 ...
Page 618: ...Art 721296 00A Rev Date 07 16 08 ...
Page 620: ...REV DATE 16 Oct 12 ART 714446 00L ...
Page 627: ...PROCEDURE MANUAL FOR THE i STAT SYSTEM 6 REV DATE 16 Oct 12 ART 714446 00L ...
Page 628: ...PROCEDURE MANUAL FOR THE i STAT SYSTEM 7 REV DATE 16 Oct 12 ART 714446 00L ...
Page 629: ...PROCEDURE MANUAL FOR THE i STAT SYSTEM 8 REV DATE 16 Oct 12 ART 714446 00L ...
Page 630: ...PROCEDURE MANUAL FOR THE i STAT SYSTEM 9 REV DATE 16 Oct 12 ART 714446 00L ...
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