i-STAT CHEM8+ Cartridge

Abbott Cartridge PROVIDING LAB-QUALITY RESULTS IN MINUTES

A wide range of cartridges for diagnostic testing at the bedside

• The CHEM8+ CARTRIDGE is a FDA-cleared and CLIA-waived single-use, in vitro diagnostic test that combines a battery of basic metabolic tests including Sodium (Na),Potassium (K),Chloride (Cl),Urea Nitrogen (BUN)/Urea
  ,Glucose (Glu),Creatinine (Crea),Ionized Calcium (iCa),TCO2,Hematocrit (Hct),Anion Gap* (Angap),Hemoglobin* (Hb).
• Preparation for Use: Individual cartridges may be used after standing five minutes at room temperature. Anentire box of cartridges should stand at room temperature for one hour.All cartridges should be used immediately after opening pouch. If the pouch has beenpunctured, the cartridge should not be used.
• Sample Type: Fresh whole blood from arterial, venous, or skin punctures.
• Sample Volume:95 μL
• Analysis Time:typically 130 to 200 seconds
• Package:25 Tests
• Shelf Life:Refrigerated at 2 to 8ºC (35 to 46ºF) until expiration date.
• Room temperature at 18 to 30ºC (64 to 86ºF) for two weeks.
• NO RETURNS ;REFUNDS or EXCHANGES ARE ACCEPTED AFTER ORDER IS PLACED BY ONLINE.

• Note Regarding System Reliability:The i-STAT 1 System automatically runs a comprehensive set of quality checks of analyzerand cartridge performance each time a sample is tested. This internal quality system willsuppress results if the analyzer or cartridge does not meet certain internal specifications(see Quality Control section in System Manual for detailed information). To minimize theprobability of delivering a result with medically significant error the internal specificationsare very stringent. It is typical for the system to suppress a very small percentage ofresults in normal operation given the stringency of these specifications. If however theanalyzer or cartridges have been compromised, results may be persistently suppressed,and one or the other must be replaced to restore normal operating conditions.

• CLIA-WAIVED Granted waived status for sodium or lithium heparin whole-blood venous samples only.

• The CHEM8+ cartridge can only be used with the i-STAT 1 analyzer.

• *For in vitro diagnostic use only.