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 blood glucose monitoring system by
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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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Plasma glucose levels ranged from 4.17 mmol/L to 22.06 mmol/L.
Hematocrit levels ranged from 31 to 59%. The C
with the C meter met the overall accuracy requirement of
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the ISO 15197 standard: Greater than 96% of readings fell within
+/- 0.83 mmol/L or +/- 20% of the laboratory value.
Precision: The C blood glucose monitoring system was
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tested with five heparinized whole blood specimens with glucose
levels from 2.4 to 33.2 mmol/L. Multiple replicates (n=36) were
tested on each of forty-seven lots of C
strips. The within-run precision is summarized in the table below:
Plasma/Serum:
Mean
2.4 mmol/L 0.07 mmol/L
3.7 mmol/L 0.08 mmol/L
7.5 mmol/L 0.13 mmol/L
18.6 mmol/L 0.29 mmol/L
33.2 mmol/L 0.65 mmol/L
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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Need Help? Bayer Diabetes Care Helpline: 1-800-268-7200
blood glucose monitoring
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test strip
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blood glucose test
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Coeffi cient
SD
of variation
3.0%
2.2%
1.8%
1.6%
2.0%
Potential Biohazard
Healthcare professionals or persons using this system on
multiple patients should follow the infection control proce-
dure approved by their facility. All products or objects which
come in contact with human blood, even after cleaning,
should be handled as if capable of transmitting viral dis-
eases. The user should follow the recommendations for the
prevention of blood-borne transmissible diseases in health-
care settings as recommended for potentially infectious
human specimens prior to repair service or investigation.
Specifi cations:
Test Sample: Whole blood
Test Result: Referenced to plasma/serum glucose
Sample Volume: 0.6 μL
Measuring Range: 0.6–33.3 mmol/L
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: 47.5 grams (1.7 oz.)
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. You will hear
twenty beeps when a programmed alarm sounds.
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