Spirit Healthcare TEE2+, Руководство владельца

Страница: 55 / 68

www.spirit-healthcare.co.uk 55
Performance Characteristics
System Accuracy and Measurement Precision
The performance of TEE2 Plus Blood Glucose Monitoring
System has been evaluated in laboratory and in clinical tests.
Accuracy:
The accuracy of the TEE2 Plus Blood Glucose
Monitoring System (Model GM01BAC) 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.
Slope 1.046
Y-intercept -0.17 mmol/L
Correlation coefficient (r) 0.9959
Number of Subjects 100
Range tested 2.2–26.0 mmol/L
System accuracy results for glucose concentration < 5.55 mmol/L
Within ±0.28 mmol/L Within ±0.56 mmol/L Within ±0.83 mmol/L
125/174 (71.8 %) 164/174 (94.3 %) 174/174 (100.0 %)
System accuracy results for glucose concentration ≥ 5.55 mmol/L
Within ±5% Within ±10 % Within ±15 %
276/426 (64.8 %) 387/426 (90.8 %) 425/426 (99.8 %)