Limitation - EPS Bio Technology EasyMax Voice III User Manual

Limitation

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 a temperature between 10°C - 40°C (50°F - 104°F). 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. Red blood cell count (Hematocrit); Hematocrit levels between 30% and 55% will not significantly affect the
results, Hematocrit levels below 30% may cause higher results, Hematocrit levels above 55% may cause
lower results. If you do not know your hematocrit level, please consult with your healthcare professional.
6. Altitude up to 3048 meters 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 fail:
♦ Severe dehydration
♦ Severe hypotension (low blood pressure)
♦ Shock
♦ A state of hypoglycemic-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
EasyMax Voice III Glucose Meter.
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