CONTOUR NEXT GEN - INTENDED USE; CONTOUR DIABETES App Purpose; IMPORTANT SAFETY INFORMATION; Critical Warnings and Usage Restrictions

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Contour
®
next GEN blood glucose monitoring system
use on supported Apple iOS and Android devices and is designed to
be used with a wirelessly enabled
Contour branded meter.
IMPORTANT SAFETY INFORMATION
WARNING
If your blood glucose reading is under the critical level you
have established with your health care professional, follow
their advice immediately.
If your blood glucose reading is over the recommended limit
set by your health care professional:
1. Wash and dry your hands well.
2. Retest with a new strip.
If you get a similar result, follow your health care professional’s
advice immediately.
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 ow. Shock, severe hypotension and
severe dehydration are examples of clinical conditions that may
adversely aect the measurement of glucose in peripheral blood.
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Talk to Your Health Care Professional:
• Before setting any Target Ranges in your meter or in the
Contour Diabetes app.
• Before changing your treatment or medication based on test results.
• About whether Alternative Site Testing (AST) is appropriate for you.
• Before making any other decision of medical relevance.
INTENDED USE
The Contour
®
next GEN blood glucose monitoring system is intended
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 eectiveness of the
patient’s diabetes control. The Contour next GEN blood glucose
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 ngertip or palm.
The Contour next GEN blood glucose monitoring system is intended
for self-testing outside the body (in vitro diagnostic use).
The
Contour next GEN blood glucose monitoring system should
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
Contour
®
next test strips are for use with the Contour
®
next GEN
blood glucose meter to quantitatively measure glucose in venous blood
and fresh capillary whole blood drawn from the ngertips 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: Contour Diabetes app
The Contour
®
Diabetes app is intended for use by individuals with
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
Contour family of meters. Other related health indicators which can
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