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Problem
Troubleshooting
• Check whether the test strip is
inserted with the contact bars facing
up. Check if the strip has been
inserted completely till the end.
• Check whether the batteries are
inserted with the ‘+’ side facing up.
• Replace the batteries.
• Check if the confirmation window is
filled adequately.
• Repeat the test after inserting a new
test strip.
• Repeat the test after inserting a new
test strip.
• Check the validity period of the test
strip.
• Check the meter.
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
doesn’t match your
expectation.
General Troubleshooting
Note:
If the problem is not resolved, please contact your authorized
i-SENS sales representative.
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
0.961
Y-intercept
3.5 mg/dL
Correlation coefficient (r)
0.995
Number of sample
110
Range tested
30 ~ 485 mg/dL
Within ± 5 mg/dL
(Within ± 0.28 mmol/L)
Within ±10 mg/dL
(Within ± 0.56 mmol/L)
Within ±15 mg/dL
(Within ± 0.83 mmol/L)
Within ± 5%
Within ± 10%
Within ± 15%
Within ± 20%
45/93 (48%)
88/93 (96%)
93/93 (100%)
93/93 (100%)
13/17 (76%)
Accuracy results for glucose concentration<75 mg/dL (4.2 mmol/L)
Accuracy results for glucose concentration
≧
75 mg/dL (4.2 mmol/L)
16/17 (94%)
17/17 (100%)
