Technical Information; Specifi Cations - Bayer HealthCare Contour User Manual

Technical Information:

Accuracy: The accuracy of the C
system has been assessed in a correlation study conducted by health-
care professionals. In this study, 108 fresh capillary blood specimens
were tested with the C
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108 untrained people with diabetes using three test strip lots. The
reference measurement was done on the YSI Glucose Analyzer.
C data compare well with the results from the YSI method.
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Regression Statistics (Plasma/Serum Reference):
plasma reference glucose range: 75 to 397 mg/dL
Lot y =
1 1.02x – 0.12 mg/dL
2 1.03x – 4.34 mg/dL
3 0.95x – 0.41 mg/dL
Precision: A study was conducted with the C
monitoring system with five heparinized whole blood specimens with
glucose levels from 40 to 325 mg/dL. Multiple replicates (n=100)
were tested using multiple C
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lot of C blood glucose test strips. The following precision
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results were obtained:
Plasma/Serum:
Mean
38 mg/dL 1.9 mg/dL
101 mg/dL 5.1 mg/dL
118 mg/dL 4.4 mg/dL
205 mg/dL 6.8 mg/dL
326 mg/dL 11.7 mg/dL
Your C blood glucose meter is specific for glucose and has
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been referenced to plasma/serum values. Methods calibrated to
plasma/serum can be 9 to 15% higher than the results of whole blood
glucose assay methods.
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® blood glucose monitoring
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blood glucose monitoring system by
Correlation
Coeffi cient (r)
0.972
0.963
0.974
blood glucose
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blood glucose meters and one
Coeffi cient
SD
of variation
4.8%
5.1%
3.7%
3.3%
3.6%
Potential Biohazard
Healthcare professionals or persons using this sys-
tem on multiple patients should follow the infection
control procedure approved by their facility. All prod-
ucts or objects which come in contact with human
blood, even after cleaning, should be handled as if
capable of transmitting viral diseases.
Specifi cations:
Test Sample: Whole blood
Test Result: Referenced to plasma/serum glucose
Sample Volume: 0.6 μL
Measuring Range: 10–600 mg/dL
Measuring Time: 5 seconds
Memory Feature: Stores most recent 480 test results
Battery Type: Two 3-volt lithium batteries
(DL2032 or CR2032)
Battery Life: Approximately 1000 tests (1 yr. average use)
Operating Temperature Range:
Humidity: 10–93% RH
Dimensions: 77 mm (H) x 57 mm (W) x 19 mm (T)
Weight: 1.7 oz. (47.5 grams)
Alarm: A beep sounds when the meter is turned on, a test
strip is inserted, when a test strip is filled with blood,
or when a test result appears on the display. Two
beeps sound when the meter turns off or to indicate
an error. Twenty beeps will sound when a pro-
grammed alarm goes off.
www.bayerdiabetes.com/us
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