Intended Use:
1. Use with Metene TD-4116 blood glucose monitoring system to quantitatively measure glucose in fresh capillary whole blood from the finger, palm, forearm, and upper arm.
2. Intended for single-patient use (lay-users at home) and should not be shared. It should not be used for the diagnosis of or screening for diabetes, nor for use on neonates.
Limitation:
1. Hematocrit: limited to 20% ~ 60%.
2. Do not test blood glucose during or soon after the xylose absorption test. Xylose in the blood will elevate the results.
3. The device is not intended for use in health care or auxiliary Settings, such as hospitals, physician offices or long-term care facilities.
Storage and Use:
1. Expiration: 6 months after first opening.
2. Storage conditions: 39.2℉ ~ 104℉, 10% ~ 85% R.H, keep dry and cold.
3. Make sure the surface of strip is free from moisture or other contamination and avoid touching the blood sampling area of the strip.
4. Close the bottle after taking out the strip. It is best to use the strip within 3 minutes after taking it out.
Read Your Result:
1. Your blood glucose readings deliver plasma equivalent results and are displayed in milligrams of glucose per deciliter of blood (mg/ml) or millimoles per liter of blood (mmol/L).
2. Normal plasma glucose range for people without diabetes:
Fasting and before meals: ≤100 mg/ml (5.6 mmol/L)
2 hours after a meal: ≤140 mg/ml (7.8 mmol/L)
Performance Characteristics:
1. Blood size: 0.7 µl
2. Reaction time: 7 seconds
3. Measurement range: 20~600 mg/dL(1.1~33.3 mmol/L)
4. Hematocrit range: 30% ~ 55%
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