Safety Information

Performance Characteristics
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This study shows that the system compares well with a laboratory method
and meets the minimum acceptable performance criteria defined in
IEC 60601-1-2.
The performance of the system has been evaluated both in laboratory and
in clinical tests.
Range: The display range of the meter is 2.2mmol/L to 33.3 mmol/L
(40mg/dL to 600 mg/dL). "HI" and "Lo" messages indicate results
outside of this range.
• Accuracy: The accuracy of the system was assessed by comparing
blood glucose results obtained using EKF Glucose Analyzer, a laboratory
instrument.
Table1. System accuracy results for glucose concentration <5.55 mmol/L
Table2. System accuracy results for glucose concentration ≥5.55mmol/L
Within ±0,28 mmol/L Within ±0,56 mmol/L
Within± 0,83 mmol/L
Percentage
Within ±10 % Within ±15 % Within ±20 %
generally should fall within 0.83mmol/L (15 mg/dL) of the laboratory
result.
If the blood glucose is below 5.55mmol/L(100mg/dL), the results
the results generally should fall within ±15 % of the laboratory result.
If the blood glucose is equal to or over 5.55mmol/L（100mg/dL),
Bias
Bias
Percentage
(within ±5mg/dl)
(within ±10mg/dl)
(within ±15mg/dl)
67.4%(287/426) 99.8%(425/426) 100.0%(426/426)
131/174 (75.3%) 173/174 (99.4%) 174/174(100.0%)