System Performance Information - Bayer HealthCare Contour USB User Manual

Blood gluvose monitoring system
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End of Meter Life/Battery Removal:
NOTE:
Carry out this process only when you
no longer intend to use the meter. Meter will
not be functional once opened to remove
the battery.
To remove the battery for proper disposal, you will
need to pry the upper and lower cases apart.
With a screwdriver, beginning near the strip port,
insert the tip of the screwdriver and twist to pry
the case loose. Continue to do this down the side
until the upper case comes apart.
Pry off the black plastic cover over the battery (A).
Disconnect the battery from the connector (B).
A
Dispose of the meter and lithium polymer
battery in accordance with your local/country
laws and regulations.
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B

System Performance Information:

Intended Use:
®
The CONTOUR
USB system (meter, test strips and
control) is intended for self-testing by people with
diabetes to monitor glucose concentrations in whole
blood. Capillary samples may be drawn from alternative
site testing sites (palm and forearm). The test provides
a quantitative measurement of glucose in blood from
20 to 600 mg/dL. The CONTOUR USB system is not
intended for the diagnosis of or screening for diabetes
mellitus and is not intended for use on neonates.
CAUTION:
For in vitro diagnostic use only.
• WARNING: Potential Biohazard
The CONTOUR USB meter is intended for use with
only one person. All products or objects that come in
contact with human blood, even after cleaning, should
be handled as if capable of transmitting viral diseases.
Principles of the Procedure:
®
The CONTOUR
blood glucose test is based on
measurement of electrical current caused by the
reaction of glucose with the reagents on the electrode
of the strip. The blood sample is drawn into the tip
of the test strip through capillary action. Glucose in
the sample reacts with FAD glucose dehydrogenase
(FAD-GDH) and potassium ferricyanide. Electrons are
generated, producing a current that is proportional to
the glucose in the sample. After the reaction time, the
glucose concentration in the sample is displayed. No
calculation is required.
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