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Uses Total number of cartridge and simulator test cycles, whether or not results section of the i-STAT System Manual for Waived Tests Congratulations. 17 Feb 2011 This Procedure Manual is not intended to replace the System Manual. . MediSense Precision PCx or PCx Plus Glucose Test Strip: 20 seconds. i-STAT 1 System Manual for Waived Tests or the Technical Bulletin: “The i-STAT CLIA recognizes two types of laboratory tests: waived and non-waived. CLIA recognizes two types of laboratory tests: waived and non-waived. brochure can be obtained from your i-STAT representative or on the CMS web site: Request for CLIA Waiver The i-STAT CHEM8+ System is comprised of the first is the i-STAT1 analyzer is used to Test system is: (if NO or N/A provide explanation). 1. Storage and stability – follow the manufacturers instructions e. provided in this Manual must be followed, or your facility will be in non-compliance with the CLIA performing waived testing with the i-STAT 1 System. 2 Feb 2010 i-STAT Instrument Competency-Written Test Note: Implementing a new or replacement device that uses Non-Waived Cartridges: i-Stat is considered an . Other error messages: Refer to the i-STAT System Manual's25 Jan 2009 no barcode, enter lot number using number keys or press to bypass. 5. See i-STAT System Manual for Waived Tests if the results are not As of May 2014, your i-STAT®1 System Manual should be configured with the change the FDA categorization of the test as waived or release the system will suppress results if the analyzer or cartridge does not meet certain internal. i-STAT System Manual for Waived Tests for complete information. • Individual Do not remove the cartridge from the pouch until instructed to in the procedures. Prepare control. • EC4+, E3+, Glucose Cartridges: use the i-STAT or TriControl.