i-SENS CARESENS DUAL, Руководство владельца

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Within Run Precision
Blood avg. 2.5 mmol/L 0.1 mmol/L
Blood avg. 4.3 mmol/L 0.2 mmol/L
Blood avg. 6.9 mmol/L CV = 4.2%
Blood avg. 10.3 mmol/L CV = 3.3%
Blood avg. 16.3 mmol/L CV = 3.0%
Precision: The precision studies were performed in a laboratory
using CareSens Dual Blood Glucose Monitoring Systems.
Between Run Precision
Control avg. 2.3 mmol/L 0.1 mmol/L
Control avg. 6.7 mmol/L CV = 4.1%
Control avg. 17.3 mmol/L CV = 3.1%
This study shows that there could be variation of up to 4.2%
Within ± 0.83 mmol/L and Within ± 15%
598/600 (99.7%)
System accuracy results for glucose concentrations between
2.6 mmol/L and 29.2 mmol/L
Packed Cell Volume (Hematocrit)
The hematocrit levels (15–65%) were tested to evaluate the effect of
hematocrit level on measurement of glucose concentration.
1.7 to 2.8 -0.2–0.1 mmol/L
5.3 to 8.0 -3.6–1.7 %
215.5 to 23.3 -8.9–6.2 %
Range mmol/L Average of difference (Hct 15–65%)
Performance Characteristics
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.
Slope 0.964
y-intercept 0.199 mmol/L
Correlation coefficient (r) 0.997
Number of tests
600
Range tested 2.6–29.2 mmol/L
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 < 5.55 mmol/L
System accuracy results for glucose concentration ≥ 5.55 mmol/L
197/204 (96.6%) 203/204 (99.5%)
Within ± 0.56 mmol/L Within ± 0.28 mmol/L Within ± 0.83 mmol/L