CONTOUR NEXT ONE User Manual page 2

INTENDED USE
The C N ONE blood glucose monitoring system is intended
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to be used for the measurement of blood glucose in both insulin and
non-insulin treated patients with diabetes as an aid for patients and
their health care professionals in monitoring the effectiveness of the
patient's diabetes control. The C
monitoring system is intended for self-testing by persons with diabetes
and health care professionals for use on a single patient in venous
blood and fresh capillary whole blood drawn from the fingertip or palm.
The C N ONE blood glucose monitoring system is intended
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for self-testing outside the body (in vitro diagnostic use).
The C N ONE blood glucose monitoring system should
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not be used for the diagnosis of or screening for diabetes or for
neonatal use. Alternative site testing (palm) should be done only
during steady state times (when glucose is not changing rapidly). The
C N test strips are for use with the C
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blood glucose meter to quantitatively measure glucose in venous
blood and fresh capillary whole blood drawn from the fingertips or
palm. The meter is for the quantitative measurement of glucose in
whole blood from 0.6 mmol/L–33.3 mmol/L.
The meter and lancing device are for single-patient use only.
The system is intended for in vitro diagnostic use only.
INTENDED USE: C
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The C D app is intended for use by individuals with
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insulin and non-insulin treated diabetes, and/or their caregivers, to
store, view, trend, and share blood glucose meter readings, either
manually entered in the app or wirelessly transmitted from the
C family of meters. Other related health indicators which can
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be captured and shown in a printable report and graphical format on a
mobile device for insulin and non-insulin treated patients with diabetes
are available to support diabetes management. The app is available
for use on supported Apple iOS and Android devices and is designed
to be used with a wirelessly enabled C
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N ONE blood glucose
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D app
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branded meter.
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IMPORTANT SAFETY INFORMATION
Serious Illness
The system should not be used to test critically ill patients.
Capillary blood glucose testing may not be clinically appropriate
for persons with reduced peripheral blood flow. Shock, severe
hypotension and severe dehydration are examples of clinical
conditions that may adversely affect the measurement of glucose
in peripheral blood.
Talk to Your Health Care Professional:
• Before setting any Target Ranges in the C
• Before changing your medication based on test results.
• If your blood sugar reading is under 2.8 mmol/L follow medical
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advice immediately.
• If your blood sugar reading is over 13.9 mmol/L, or the critical
level you have established with your health care professional:
1. Wash and dry your hands well.
2. Retest with a new strip.
If you get a similar result, call your health care professional
as soon as possible.
• About whether Alternative Site Testing (AST) is appropriate
for you.
C N
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WARNING
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ONE blood glucose monitoring system
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D app.
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