iGlucose - General Usage Caution Points and Limitations
General usage caution points:
- The iGlucose Blood Glucose Meter and iGlucose Lancing Device are for single patient use. Do not use on multiple patients. Do not share meter with anyone including other family members.
- Do not use the lancing device for assisted blood draws by healthcare providers or at healthcare provision sites and do not share it with anyone else, even a family member.
- Before using the iGlucose System to test your blood glucose, please read all of the instructions.
- Please perform a quality control test with control solution regularly to make sure the test results are accurate.
- The iGlucose Meter can only be used with the iGlucose Blood Glucose Test Strips. Other test strips should not be used under any circumstances. The use of other test strips may give inaccurate results.
- The iGlucose® Blood Glucose Monitoring System is intended for in vitro diagnostic use only. The blood glucose test results using fresh capillary whole blood samples from the fingertip are calibrated to be equivalent to plasma samples.
- iGlucose Blood Glucose Test Strips are designed for use with capillary whole blood samples. Do not use serum or plasma samples.
- The iGlucose Monitoring System should not be used to screen for or diagnose diabetes mellitus.
- If the iGlucose Blood Glucose Meter and iGlucose Test Strips are exposed to a substantial change in temperature, please wait 45 minutes before measurement.
- The iGlucose System is not for use on newborn babies or the critically ill.
- All parts of the kit are considered biohazardous and can potentially transmit infectious diseases, even after following the cleaning and disinfecting procedures.
- Users should wash their hands thoroughly with soap and water before and after handling the meter, lancing device, or test strips.
- This device is not for use on anyone in a hyperglycemic hyperosmolar state, with or without ketosis.
- Hands and fingers contaminated with sugar from foods or beverages may cause falsely elevated results.
- In accurate 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 Ascorbic Acid 0.34 mmol/L (6mg/dL), Glutathione reduced 2.28 mmol/L (70 mg/dL), Uric acid 0.95 mmol/L (16 mg/dL), Cholesterol 18.10 mmol/L (700 mg/dL), Hemoglobin 0.31 mmol/L (2,000 mg/dL) may interfere with the glucose test causing inaccurate test results. Please check with your doctor before using the iGlucose 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.