General Troubleshooting; Performance Characteristics - i-SENS CareSens N User Manual

General Troubleshooting

Problem
• Check whether the test strip is inserted
with the contact bars facing up.
• Check if the strip has been inserted
The display is
completely into the test strip port.
blank even after
• Check if the appropriate test strip was
inserting a test
used.
strip.
• Check if the batteries are inserted
correctly.
• Replace the batteries.
The test does not
• Check if the confirmation window is
start even after
filled adequately.
applying the blood
• Repeat the test after inserting a new
sample on the test
test strip.
strip.
• Repeat the test after inserting a new
test strip.
The test result does
not match the way • Check the validity period of the test
you feel. strip.
• Perform control solution test.
Note: If the problem is not resolved, please contact Customer
Service: 1-800-429-5001 (9 am - 9 pm EST, Monday - Saturday).
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Troubleshooting

Performance Characteristics

The performance of CareSens N Blood Glucose Monitoring
System has been evaluated in laboratory and clinical tests.
Accuracy: The CareSens N BGM System is calibrated to yield
results equivalent to plasma glucose concentrations. The
accuracy of the CareSens N System (Model GM505NA, GM505NB,
GM505NC) 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.
Obtained by healthcare
professionals
Slope 1.023
Y-intercept -1.86 mg/dL
Correlation coefficient(r) 0.995
Number of sample 110
Range tested 30 - 485 mg/dL
Accuracy results for glucose concentration < 75 mg/dL
Within ± 5 mg/dL Within ± 10 mg/dL
14/17 (82%) 17/17 (100%)
Accuracy results for glucose concentration ≥ 75 mg/dL
Within ± 5% Within ± 10%
54/93 (58%) 82/93 (88%)
Obtained by
lay users
1.032
-3.63 mg/dL
0.985
105
67 - 413 mg/dL
Within ± 15 mg/dL
17/17 (100%)
Within ± 15% Within ± 20%
93/93 (100%) 93/93 (100%)
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