CALIBRATION VERIFICATION
15
Art: 714377-00K Rev. Date: 31-Jan-12 15-1
CALIBRATION VERIFICATION FOR BLOOD GAS/ELECTROLYTE/METABOLITE CARTRIDGES
(EXCEPT CHEM8+ CARTRIDGES)
Purpose
Calibration Verification is a procedure intended to verify the accuracy of
results over the entire measurement range of a test. The performance of this
procedure at defined intervals may be required by regulatory or accreditation
bodies. While the Calibration Verification Set contains five levels, verification
of the measurement range could be accomplished using the lowest, highest
and mid levels.
Overview of Procedure
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.
Calibration Verification
Solutions for
Cartridges
A five-level Calibration Verification Set is available to verify the calibration
of i-STAT cartridges throughout the reportable ranges for:
Sodium pH Glucose
Potassium PCO
2
Lactate
Chloride PO
2
BUN/Urea
Ionized Calcium Creatinine
There are four 1.7mL glass ampules of each level in the set.
Storage
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. 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.
If stored refrigerated, the calibration verification material should be equilibrated
to room temperature for at least four (4) hours prior to testing.
Ampule Use
When using cartridges that contain sensors for pH, PCO
2
, PO
2
and ionized
calcium, a separate ampule must be used for each cartridge being tested. If
these sensors are not present, the contents of one ampule may be used to fill
more than one cartridge as long as the cartridges are filled and inserted into
an analyzer within 10 minutes of opening the ampule.
Best Results
For best results, ampules, cartridges and analyzers should be at the same
temperature.
Reactive Ingredients
See the table on page 14-3 of the Quality Control section for full information.
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