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

General Troubleshooting
Problem
• Check whether the test strip is
inserted with the contact bars facing
up. Check if the strip has been
The display is blank
inserted completely till the end.
even after inserting
a test strip. • Check whether the batteries are
inserted with the '+' side facing up.
• 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 strip.
test strip.
• Repeat the test after inserting a new
test strip.
The test result
doesn't match your • Check the validity period of the test
expectation. strip.
• Check the meter.
Note:
If the problem is not resolved, please contact your authorized
i-SENS sales representative.
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Troubleshooting
Performance Characteristics
The performance of CareSens N Blood Glucose Monitoring
System Strips has been evaluated in laboratory and in clinical
tests.
Accuracy: The accuracy of the CareSens N BGM System (Model
GM505NA, GM505NB, GM505NC) 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 110 diabetic patients at
clinic centers.
Slope
Y-intercept
Correlation coefficient (r)
Number of sample
Range tested
Accuracy results for glucose concentration<75 mg/dL (4.2 mmol/L)
Within ± 5 mg/dL Within ±10 mg/dL
(Within ± 0.28 mmol/L) (Within ± 0.56 mmol/L)
13/17 (76%) 16/17 (94%)
Accuracy results for glucose concentration≧75 mg/dL (4.2 mmol/L)
Within ± 5% Within ± 10%
45/93 (48%) 88/93 (96%)
0.961
3.5 mg/dL
0.995
110
30 ~ 485 mg/dL
Within ±15 mg/dL
(Within ± 0.83 mmol/L)
17/17 (100%)
Within ± 15% Within ± 20%
93/93 (100%) 93/93 (100%)
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