PROCEDURE MANUAL FOR THE i-STAT SYSTEM1REV. DATE: 16-Oct-12 ART: 714446-00LSYSTEM OVERVIEWThe i-STAT System incorporates comprehensive components needed to perform blood analysis at the point of care. TheSystem consists of the following primary components:AnalyzersAnalyzers (handhelds) can be the i-STAT Portable Clinical Analyzer or the i-STAT 1 Analyzer. When a sample-filledi-STAT cartridge is inserted into a handheld for analysis, the handheld automatically controls all functions of the testingcycle including fluid movement within the cartridge, calibration and continuous quality monitoring.Analysis Time ACT cartridge: to detection of end point - up to 1000 seconds (16.7 min.) PT/INR cartridge: to detection of end point – up to 300 seconds (5 min.) cTnI and BNP cartridges: 600 seconds (10 min.) CK-MB Cartridge: 300 seconds (5 min.) Other cartridges: typically 130 to 200 secondsCartridgesA single-use disposable cartridge contains microfabricated sensors, a calibrant solution, fluidics system, and a wastechamber. Sensors for analysis of pH, PCO 2 , PO 2 , TCO 2 , sodium, potassium, chloride, ionized calcium, glucose, lactate,creatinine, urea nitrogen (BUN) and hematocrit are available in a variety of panel configurations. Cartridges are alsoavailable for Celite-ACT, Kaolin-ACT, PT/INR, Troponin I/cTnI, CK-MB and BNP (Table 1). A whole blood sample ofapproximately 1 to 3 drops is dispensed into the cartridge sample well, and the sample well is sealed before inserting it intothe analyzer.Central Data Station or Data ManagerA dedicated desktop computer with the i-STAT Central Data application provides the primary information managementcapabilities for the i-STAT System. IR Links for Portable Clinical Analyzers and Downloaders and Downloader/Rechargersfor the i-STAT 1 Analyzers allow for transmission of patient records from a widely distributed network of handhelds to theCentral Data Station application. Data can be stored, organized, edited, and transferred to a laboratory information system orother computer system. Cartridge usage and efficiency reports can be generated for management of the System.SUPPLIES and STORAGE REQUIREMENTSCartridgesCartridges are sealed in individual pouches or portion packs. Store the main supply of cartridges at a temperature between 2to 8°C (35 to 46°F). Do not allow cartridges to freeze. Cartridges may be stored at room temperature (18 to 30°C or 64 to86°F) for the time frame indicated on the cartridge box. Cartridges should not be returned to the refrigerator once they havebeen at room temperature, and should not be exposed to temperatures above 30°C (86°F). If the pouch has been punctured,the cartridge should not be used. Write the date on the cartridge box or individual cartridge pouches to indicate the roomtemperature expiration date. Cartridges should remain in pouches until time of use. Do not use after the labeled expirationdate.
