i-SENS NoCoding1 Plus, Руководство владельца

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General Troubleshooting Performance Characteristics
The performance of NoCoding1 Plus Blood Glucose Monitoring
System has been evaluated in laboratory and in clinical tests.
Accuracy: The accuracy of the NoCoding1 Plus BGM System
(Model GM01BAA) 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 0.9935
Y-intercept 4.1293 mg/dL (0.23 mmol/L)
Correlation coefficient (r) 0.9932
Number of Subjects
100
Range tested 28.7–486 mg/dL
(1.6–27.0 mmol/L)
Within ± 5% Within ± 10% Within ± 15%
262/426 (61.5%) 394/426 (92.5%) 424/426 (99.5%)
System accuracy results for glucose concentration ≥ 100 mg/dL
(5.55 mmol/L)
87/174 (50.0%)
System accuracy results for glucose concentration < 100 mg/dL
(5.55 mmol/L)
158/174 (90.8%) 174/174 (100.0%)
Within ± 10 mg/dL
(Within ± 0.56 mmol/L)
Within ± 5 mg/dL
(Within ± 0.28 mmol/L)
Within ± 15 mg/dL
(Within ± 0.83 mmol/L)
Note: If the problem is not resolved, please contact your
authorised i-SENS sales representative.
Problem Troubleshooting
The display is blank
even after inserting
a test strip.
• Check whether the test strip is
inserted with the contact bars facing
up. Check if the strip has been inserted
completely into the test strip port.
• Check if the appropriate test strip was
used.
• Check whether the batteries are
inserted with the ‘+’ side facing up.
• Replace the batteries.
The test does not
start even after
applying the blood
sample on the strip.
• Check if the confirmation window is
filled completely.
• Repeat the test after inserting a new
test strip.
The test result
doesn't match the
way you feel.
• Repeat the test after inserting a new
test strip.
• Check the expiration date of the test
strip.
• Perform control solution test.