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Endomedical Bravo - Troubleshooting and Performance; General Troubleshooting Guide; Performance Accuracy Data; Accuracy Metrics by Glucose Level

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BLOOD GLUCOSE MONITORING SYSTEM
42
www.endomedical.ca
43
The display is
blank even after
inserting a test
strip.

with the contact bars facing up.
Check if the strip has been inserted
completely into the test strip port.

used.

inserted with the + side facing up.

The test does
not start even
after apply-
ing the blood
sample on the
strip.

filled completely.

test strip.
The test result
does not match
the way you
feel.

test strip.

strip.

date (date of opening the test strip vial
plus 6 months).

GENERAL TROUBLESHOOTING
PROBLEM TROUBLESHOOTING
Within ± 0.28 mmol/L Within ± 0.56 mmol/L Within ± 0.83 mmol/L
8/8 (100%) 8/8 (100%) 8/8 (100%)
Within ± 5% Within ± 10% Within ± 15% Within ± 20%
49/106 (46%) 82/106 (77%) 101/106 (95%) 106/106 (100%)
The performance of Bravo™ Blood Glucose Monitoring
System has been evaluated in laboratory and in clinical tests.
Accuracy: The accuracy of the Bravo™ BGM System (Model
GM505MA, GM505MB, GM505MC, GM505MD, GM505ME)
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 0.97
Y-intercept -0.13 mmol/L
Correlation coefficient (r) 0.993
Number of Sample 114
Range tested 2.5–32.5 mmol/L
Accuracy results for glucose concentration < 4.2 mmol/L
PERFORMANCE CHARACTERISTICS
Accuracy results for glucose concentration 4.2 mmol/L
If the problem is not resolved, please contact your
authorized Endomedical™ sales representative
Note