Abbott i-STAT 1 System Manual page 227

Acceptable Criteria
i-STAT CHEM8+ CALIBRATION VERIFICATION LEVEL 1B
Overview of Procedure
Calibration Verification
Solution for CHEM8+
Cartridges
Storage
Ampule Use
Best Results For best results, ampules, cartridges and analyzers should be at the same
temperature.
Before Use Equilibrate the ampule to room (ambient) temperature for 30 minutes.
Art: 714377-01O
Target values (determined by testing multiple ampules of each level using multiple
lots of i-STAT cartridges with analyzers that have passed the Electronic Simulator
test) are printed on a Value Assignment Sheet posted on the APOC website at
www.pointofcare.abbott.
Calibration throughout the reportable range of each analyte is verified if each analyte
value falls within the corresponding range in the Value Assignment Sheet.
If the result for a level is outside the range published in the Value Assignment Sheet,
two additional cartridge runs should be performed on this level and the three results
averaged and then compared to the Value Assignment Sheet range. If this average
value is still outside the acceptable range, troubleshooting may be required.
Note: If the Calibration Verification Set is to be used to assess linearity, plot
the analyte value against the mean value of the acceptable range. The
concentrations of analytes in the Calibration Verification Set are not intended
or prepared to be equally spaced.
If testing at extreme altitude refer to Correction of PO
Controls for Blood Gas/Electrolyte/Metabolite Cartridges in the Quality Control
section of the manual.
i-STAT recommends that each sensor type be included in the Calibration Verification
procedure using a selection of analyzers that have passed the Electronic Simulator
check. See the Technical Bulletin "Calibration Verfication and the i-STAT System"
for more information.
i-STAT CHEM8+ Calibration Verification Level 1b is available for purchase to verify
the calibration of the i-STAT CHEM8+ TCO
There are ten 1.7 mL glass ampules in each box.
Note: For testing all CHEM8+ cartridge analytes, use either the i-STAT TriControls
Calibration Verification Set (includes hematocrit) or the i-STAT Calibration Verification
Set (does not include hematocrit).
Refrigerated storage at 2 to 8 °C (35 to 46 °F) should be maintained until the
printed expiration date on the box and ampule labels. i-STAT CHEM8+ Calibration
Verification fluids may also be stored at room temperature for up to 5 days (18 to
30 °C or 64 to 86 °F). Prolonged storage at temperatures greater than 30 °C (86
°F) may cause changes in the values of some analytes. Do not use beyond the
expiration date on the box and ampule labels.
A separate ampule must be used for each cartridge being tested.
Rev. Date: 27-Jan-17
at Extreme Altitude under
2
at the low end of the reportable range.
2
15-3