General Troubleshooting; Performance Characteristics - i-SENS CareSens N Voice Owner's Booklet

General Troubleshooting

Problem
• C heck whether the test strip is
inserted with the contact bars facing
up. Check if the strip has been
The display is blank
inserted completely into the test
even after inserting
strip port.
a test strip.
• C heck if the appropriate test strip
was used.
• C heck if the batteries are inserted
correctly.
• R eplace the batteries.
• C heck if the confirmation window is
The test does not
filled completely.
start even after
applying the blood
• R epeat the test after inserting a new
sample on the strip.
test strip.
• R epeat the test after inserting a new
test strip.
The test result
doesn't match the
• C heck the expiration date of the
way you feel.
test strip.
• Perform control solution test.
Note: If the problem is not resolved, please contact your
authorised i-SENS sales representative.
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Troubleshooting

Performance Characteristics

The performance of CareSens N Voice Blood Glucose Monitoring
System has been evaluated in laboratory and in clinical tests.
Accuracy: The accuracy of the CareSens N Voice BGM System
(Model GM505UAB) was tested by comparing blood glucose
results obtained by patients with those obtained using a YSI
Model 2300 Glucose Analyzer, a lab instrument. The results
below were obtained by diabetic patients at clinic centers.
Slope 0.9637
Y-intercept 0.11 mmol/L
Correlation coefficient (r) 0.993
Number of samples 600
Range tested 1.6-26.6 mmol/L
Accuracy results for glucose concentration < 5.55 mmol/L
Within ± 0.28 mmol/L Within ± 0.56 mmol/L
128/186 (68.8%) 179/186 (96.2%)
Accuracy results for glucose concentration ≥ 5.55 mmol/L
Within ± 5% Within ± 10%
226/414 (54.6%) 359/414 (86.7%)
Within ± 0.83 mmol/L
186/186 (100%)
Within ± 15%
413/414 (99.8%)
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