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Limitations
The test strips are used for fresh capillary whole blood samples.
1. DO NOT use neonate blood sample.
2. Extreme humidity may affect the results. A relative humidity greater than 90 % may cause incorrect results.
3. The system should be used at temperatures between 50°F and 104°F (10°C and 40°C). Outside this range,
the system may get incorrect results.
4. DO NOT reuse the test strips. The test strips are for single use only.
5. Hematocrit: The hematocrit between 20% and 60% will not affect the results. Hematocrit below 20% may
cause higher results. Hematocrit above 60% may cause lower results.
6. Altitude up to 10,000 feet above sea level has no effect on readings.
Healthcare Professionals – Please note these additional Limitations
7. Patients undergoing oxygen therapy may have inaccurate results.
8. If the patient has the following conditions, the result may fails:
Severe dehydration
Severe hypotension (low blood pressure)
Shock
A state of hyperglycemic-hyperosmolar state (with or without ketosis)
9. Lipemic samples: Cholesterol level up to 500 mg/dL and triglycerides up to 3,000 mg/dL do not affect the
results. Grossly lipemic patient samples have not been tested and are not recommended for testing with
EM44
Pro Glucose Meter.
10. Critically ill patients should not be tested with EM44 Pro glucose meters.
11. Interfering Substances depend on the concentration. The below substances up to the test concentration
will not affect the test results.
