Limitations:
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For in-vitro diagnostic use only (external use only) .
•
Not for diagnosis of or screening for diabetes .
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Not for testing of neonates .
•
The test strips are for single use only . Do not reuse test strips .
•
The system can give false results greater than 10,000 feet (3,048 meters) above sea level .
•
The system can give false results outside the hematocrit range: 15% to 65% .
•
Individuals experiencing a hypoxia state may yield falsely low results .
•
In situations of decreased peripheral blood flow, capillary blood testing may not be
appropriate as it may not represent the true physiological state . Examples would include but
are not limited to: severe dehydration caused by diabetic ketoacidosis or the hyperosmolar
non-ketotic state, hypotension, shock, or peripheral vascular disease .
•
This device should not be used to test critically ill patients .
•
Alternative site testing (AST) should not be used to calibrate continuous glucose monitors
(CGMs) nor for use in insulin dose calculations .
•
AST testing should only be done during steady-state times (when glucose is not changing rapidly) .
•
For single patient use at home by a lay user .
•
Severe dehydration or excessive water loss may cause false low results . If you believe you are
suffering from severe dehydration, consult your physician immediately .
•
Cholesterol up to 500 mg/dL or triglycerides up to 3,000 mg/dL do not significantly affect test
results . However, glucose values in specimens beyond these levels, should be interpreted with
caution .
Atkins SH, Dasmahapatra A, Jaker MA, Chorost MI, Reddy S: Fingerstick glucose determination in shock . Ann Int Med 114: 1020-
4
1024 . 1991 .
Sandler M, Low-Beer T: Misleading capillary glucose measurements . Practical Diabetes 7: 210 . 1990 .
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Wickham NWR, Achar KN, Cove DH: Unreliability of capillary blood glucose in peripheral vascular disease . Practical Diabetes 3: 100 . 1986 .
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