i-SENS e-Checker, Руководство владельца

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• Test Range: 20-600 mg/dL (1.1-33.3 mmol/L)
• Sample Size: Minimum 0.5 ㎕
• Test Time: 5 seconds
• Test Sample: Fresh capillary whole blood
• Calibration: Plasma-equivalent
• Assay Method: Electrochemical
• Power:
One (1) 3.0 V lithium battery
(non-rechargeable, replaceable, type CR2032)
• Battery Life: 1,000 tests
• Memory: 250 blood glucose values
• Dimension: 84 x 40 x 17 (mm)
• Weight: 38.5 g (battery included)
• Operating Range
Temperature: 10-40 /50-104
Relative Humidity: 10-90%
Hematocrit: 20-60%
Performance Evaluation
The performance of e-CheKer Blood Glucose Monitoring System
Strips has been evaluated in laboratory and in clinical tests.
Accuracy: The accuracy of the e-CheKer BGM System (Model
GM505FA) 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 115 diabetic patients at clinic centers.
Slope 0.961
Y-intercept 3.5 mg/dL
Correlation coefficient(r) 0.995
Number of samples 115
Range tested 40-521 mg/dL
Accuracy results for glucose concentration < 75 mg/dL
(4.2 mmol/L)
Accuracy results for glucose concentration
≧
75 mg/dL
(4.2 mmol/L)
Within
±
5 mg/dL
(Within
±
0.28 mmol/L)
13/19 (68%)
Within
±
10 mg/dL
(Within
±
0.56 mmol/L)
18/19 (95%)
Within
±
15 mg/dL
(Within
±
0.83 mmol/L)
19/19 (100%)
Within
±
5%
66/96 (69%)
Within
±
10%
92/96 (96%)
Within
±
5%
96/96 (100%)
Within
±
20%
96/96 (100%)
e-CheKer Blood Glucose
Monitoring System Specifications