i-SENS CARESENS DUAL, Руководство пользователя

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Performance Characteristics
System Accuracy and Measurement Precision
The performance of CareSens Dual Blood Glucose/Blood
β -Ketone Monitoring System has been evaluated in laboratory
and in clinical tests.
Glucose
Accuracy: The accuracy of the CareSens Dual Blood Glucose
Monitoring System (Model: GM01HAC) was assessed by
comparing blood glucose results obtained by patients with those
obtained using a YSI Model 2300 Glucose Analyzer, a laboratory
instrument.
The following results were obtained by diabetic patients at
clinic centers.
Within ±5 % Within ±10 % Within ±15 %
264/396 (66.7 %) 379/396 (95.7 %) 395/396 (99.7 %)
136/204 (66.7 %)
System accuracy results for glucose concentration < 100 mg/dL
(5.55 mmol/L)
System accuracy results for glucose concentration ≥ 100 mg/dL
(5.55 mmol/L)
197/204 (96.6 %) 203/204 (99.5 %)
Within ±5 mg/dL
(Within ±0.28 mmol/L)
Within ±10 mg/dL
(Within ±0.56 mmol/L)
Within ±15 mg/dL
(Within ±0.83 mmol/L)
Slope 0.964
Y-intercept 3.579 mg/dL (0.199 mmol/L)
Correlation coefficient (r) 0.997
Number of tests 600
Range tested 46.2–526 mg/dL (2.6–29.2 mmol/L)