i-SENS Nipro Premier alpha User Manual

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Problem Troubleshooting
• Checkwhethertheteststripis
inserted with the contact bars facing
upwards. Check if the strip has been
inserted completely into the test
strip port.
• Checkiftheappropriateteststrip
was used.
• Checkwhetherthebatteriesare
inserted with the + side facing
upwards.
• Replacethebatteries.
• Checkiftheconfirmationwindowis
filled completely.
• Repeatthetestwithanewteststrip.
• Repeatthetestwithanewteststrip.
• Checktheexpirationordiscarddate
of the test strip.
• Performcontrolsolutiontest.
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 the
way you feel.
General Troubleshooting
Note:
If the problem is not resolved, please contact your authorised
Nipro sales representative.
Performance Characteristics
The performance of Nipro Premier alpha Blood Glucose
Monitoring System has been evaluated in laboratory and in
clinical tests.
Accuracy: The accuracy of the Nipro Premier alpha BGM System
(Model GM01IAB) 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 diabetic patients at
clinic centers.
Slope 0.9975
Y-intercept -0.1 mmol/L
Correlation coefficient (r) 0.9958
Number of Tests 600
Range tested 2.1-29.5 mmol/L
Within ± 5% Within ± 10% Within ± 15%
207/414 (50%) 375/414 (90.6%) 413/414 (99.8%)
117/186 (62.9%)
System accuracy results for glucose concentration < 5.55 mmol/L
System accuracy results for glucose concentration ≥ 5.55 mmol/L
181/186 (97.3%) 186/186 (100%)
Within ± 0.56 mmol/LWithin ± 0.28 mmol/L Within ± 0.83 mmol/L

i-SENS Nipro Premier alpha Specifications

General

Brand	i-SENS
Model	Nipro Premier alpha
Category	Blood Glucose Meter
Language	English