Abstract: . . .  requirements of the particular analytical system. i-STAT Corporation recognizes the importance of effective quality control for its analytical medical devices, and has developed a program that is tailored to the unique characteristics of the i-STAT ® System. Overview The i-STAT System performs blood analysis when a unit-use cartridge filled with a patient’s sample is inserted into a hand-held analyzer or Blood Analysis Module (as part of the Hewlett Packard Omnicare Patient Monitoring System). The measurement . . .
. . .  question 4. Traditional quality control measurements verify the instrumentation using an independent device which simulates the characteristics of the electrochemical sensors in a way which stresses the performance characteristics of the instrumentation Similarities of the i-STAT Quality Control Regimen to Traditional Laboratory Quality Control Regimen Although the more significant aspects of i-STAT’s quality control regimen are the quality checks automatically performed with each unit-use cartridge, . . .
. . .  sample was properly positioned within the sample chamber every cartridge use • verify the sample is free of included bubbles every cartridge use • verify the sample is not clotted every cartridge use • verify the sample chamber is properly sealed with the snap closure every cartridge use  . . .
. . .  should also be considered when determining a validation protocol. Page 3 Quality Control and the i-STAT System © 1997 i-STAT Corporation i-STAT Lit#: 151565 All rights reserved. Printed in the USA 6/97 Automatic Quality Checks - the Backbone of the i-STAT Quality Regimen Unit-Use Cartridge When Verified Microfabricated Electrochemical Sensor Elements • verify sensors are present every cartridge use • verify sensor characteristics are consistent with expectations of a every cartridge use properly . . .
. . .  also be considered when determining a validation protocol. Page 3 Quality Control and the i-STAT System © 1997 i-STAT Corporation i-STAT Lit#: 151565 All rights reserved. Printed in the USA 6/97 Automatic Quality Checks - the Backbone of the i-STAT Quality Regimen Unit-Use Cartridge When Verified Microfabricated Electrochemical Sensor Elements • verify sensors are present every cartridge use • verify sensor characteristics are consistent with expectations of a every cartridge use properly manufactured . . .
. . .  electronic systems every cartridge use • verify fluid flow using the conductivity sensor every cartridge use • verify function of transducers used for measuring barometric pressure every cartridge use • verify function of the thermistors used to set control chip temperature Electronic Simulator Operator Sample Handling / Cartridge Handling • verify the cartridge inserted has not been previously used every cartridge use • verify the calibration pack has not prematurely ruptured every cartridge use . . .
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