Art: 715209-00E Rev. Date: 06/11/08
4
CALIBRATION VERIFICATION LEVEL RECOMMENDATIONS
Product Title Applicable Cartridges Analytes
Which Levels should
be run to verify the
reportable range?
i-STAT Calibration Verification
Set
G, Crea, E3+, EC4+, 6+, EC8+,
G3+, EG6+, EG7+, CG4+, and
CG8+
Sodium
Potassium
Chloride
Ionized Calcium
pH
PCO
2
PO
2
Glucose
Lactate
BUN/Urea
Creatinine
1, 3, and 5
i-STAT CHEM8+ Calibration
Verification Set
CHEM8+ Sodium
Potassium
Chloride
TCO
2
Ionized Calcium
Glucose
BUN/Urea
Creatinine
1, 3, and 5
Note: i-STAT CHEM8+ Level 1B
Control is available for purchase
for customers who want to test
lower levels of TCO
2
than that
contained in the Level 1 Calibration
Verification solution.
i-STAT Cardiac Marker
Calibration Verification Set.
cTnI cTnI 1, 2, and 3
RNA Medical
®
Hematocrit
Calibration Verification Controls
E3+, EC4+, 6+, EC8+, EG6+,
EG7+, CG8+, and CHEM8+
Hematocrit 1, 3, and 5
i-STAT BNP Calibration
Verification Controls
BNP BNP 1, 2, and 3
When performing the calibration verification procedure to meet a six-month calibration verification
requirement, include each sensor and a representative selection of analyzers.
NOTES:
Calibration Verification or a linearity check for hematocrit can also be performed by a manual method using
blood collected in lithium heparin tubes and manipulated to create three levels of hematocrit. Target values
for Hematocrit for this manual method can be obtained from the bench top lab analyzer.
The upper limit of the reportable range for PO
2
is 800 mmHg. The highest PO
2
level in the i-STAT Calibration
Verification set is just over 450 mmHg. Oxygen levels above 450 mmHg are so unstable in aqueous
solutions that it would be impossible to make reliable measurements above 450 mmHg. Whole blood
samples can be tonometered with 100% oxygen to create a sample around 700 mmHg at sea level.
REFERENCE
Code of Federal Regulations, 42CFR493, Subpart K – Quality System For Non-Waived Testing, §493.1255
– Standard: Calibration And Calibration Verification Procedures. (January 24, 2003)
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