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43
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 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.
Perform a test with control solution to verify the
strips are OK.
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 does
not match your
expectation.
GENERAL TROUBLE SHOOTING
NOTE!
If the problem is not resolved, please contact the manufacturer of the
blood glucose meter.
PERFORMANCE CHARACTERISTICS
The performance of Mendor SMART Blood Glucose Monitoring System has
been evaluated in laboratory and in clinical tests.
Accuracy:
The accuracy of Mendor SMART Blood Glucose Meter System
(Model:GM01CA
B
/GM01CAD) 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 100 diabetic patients at clinic centers.
Within ±0.28 mmol/L
(Within 5 mg/dL)
Within ± 5 %
Interval
System accuracy results for glucose concentration < 4.17 mmol/L (< 75 mg/dL)
System accuracy results for glucose concentration ≥ 4.17 mmol/L (≥ 75 mg/dL)
Results from repeatibility evaluation
74/96 (77.1%)
249/504 (49.4%)
1
2
3
4
5
Within ±0.56 mmol/L
(Within 10 mg/dL)
Within ± 10 %
Glucose concentration mmol/L
Within ±0.83 mmol/L
(Within 15 mg/dL)
Within ± 20 %
Pooled SD or CV
Within ± 20 %
94/96 (97.9%)
401/504 (79.6%)
1.7 to 2.8
2.9 to 6.1
6.2 to 8.3
8.4 to 13.9
14.0 to 22.2
96/96 (100%)
493/504 (97.8%)
0.1 mmol/L
0.1 mmol/L
2.8 %
2.7 %
3.0 %
504/504 (100%)
