Limitations - Smart Meter iGlucose Plus Owner's Manual

iGlucose Plus 6

LIMITATIONS

• This device is not for use on anyone in a hyperglycemic
hyperosmolar state, with or without ketosis.
• Not for use with critically ill patients.
• Hands and fingers contaminated with sugar from foods or
beverages may cause falsely elevated results.
• Inaccurate test results may be obtained at altitudes greater
than 10,000 feet (3,048 meters) above sea level.
• Hematocrit levels outside the 20-60% range may yield
inaccurate results.
• High concentrations of Uric acid >9 mg/dL, Cholesterol >600
mg/dL, and Ascorbic acid (Vitamin C) >5 mg/dL may interfere
with the glucose test causing inaccurate test results. Certain
conditions may cause your blood level of uric acid to rise. These
conditions include gout or kidney disease. This means that when
the uric acid concentration in your blood is greater than 9 mg/dL
you may get inaccurate and unreliable glucose results. Please
check with your doctor before using the iGlucose Plus Blood
Glucose Monitoring System.
• Do not perform the blood glucose test at temperatures below
50°F (10°C) or above 104°F (40°C ), nor below 10% or above
90% relative humidity.
• iGlucose Blood Glucose Test Strips are designed for use with
capillary whole blood samples. Do not use serum or plasma
samples.
• Not for screening or diagnosis of diabetes mellitus.
• For over-the-counter use. Single patient use only. For in vitro
diagnostic use only.
• Not for use on neonates or the critically ill.