i-SENS CareSens N Pop, Руководство владельца

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Problem Troubleshooting
• Check whether the test strip is
inserted with the contact bars facing
upwards. 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
upwards.
• Replace the batteries.
• Check if the confirmation window is
filled completely.
• Repeat the test with a new test strip.
• Repeat the test with a new test strip.
• Check the expiration or discard date
of the test strip.
• Perform control solution test.
The display is blank
even after inserting
a test strip.
The test does not
start even after
applying the blood
sample on the strip.
The test result
does not match the
way you feel.
General Troubleshooting
Note:
If the problem is not resolved, please contact your
authorised i-SENS sales representative.
Performance Characteristics
The performance of CareSens N POP Blood Glucose Monitoring
System has been evaluated in laboratory and in clinical tests.
Accuracy: The accuracy of the CareSens N POP Blood Glucose
Monitoring System (Model: GM505WAC, GM505WBC) 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 1.0009
Y-intercept 0.10 mmol/L
Correlation coefficient (r) 0.995
Number of samples 600
Range tested 2.0–26.4 mmol/L
Within ± 5% Within ± 10% Within ± 15%
288/444 (64.9%) 413/444 (93.0%) 443/444 (99.8%)
74/156 (47.4%)
System accuracy results for glucose concentration < 5.55 mmol/L
System accuracy results for glucose concentration ≥ 5.55 mmol/L
133/156 (85.3%) 155/156 (99.4%)
Within ± 0.56 mmol/L Within ± 0.28 mmol/L Within ± 0.83 mmol/L
System accuracy results for glucose concentrations between
2.0 mmol/L and 26.4 mmol/L
Within ± 0.83 mmol/L and Within ± 15%
598/600 (99.7%)