Calibration Verification; Calibration Verification For Blood Gas/Electrolyte/Metabolite Cartridges (Except Chem8+ Cartridges) - Abbott i-STAT 1 System Manual

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.
i-STAT recommends that each sensor type be included in the Calibration
Overview of Procedure
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

A five-level Calibration Verification Set is available to verify the calibration
Solutions for
of i-STAT cartridges throughout the reportable ranges for:
Cartridges
There are four 1.7mL glass ampules of each level in the set.
Reactive Ingredients See the table on page 14-3 of the Quality Control section for full information.
Refrigerated storage at 2 to 8 °C (35 to 46°F) should be maintained until the
Storage
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
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.
Art: 714377-00K
CALIBRATION VERIFICATION
Sodium pH
Potassium PCO
Chloride PO
Ionized Calcium
Rev. Date: 31-Jan-12
Glucose
Lactate
2
BUN/Urea
2
Creatinine
15
, PO and ionized
2 2
15-1