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GlucoMen Day Continuous Glucose Monitoring System
1.1
Introduction
Thank you for choosing the GlucoMen Day Continuous
Glucose Monitoring (CGM) System. The GlucoMen Day
CGM System provides current glucose levels. The sy-
stem tracks your glucose every minute by measuring the
amount of glucose in the interstitial fluid. A sensor, inser-
ted in your skin, sends glucose readings to the GlucoMen
Day App. The app then displays your glucose levels and
long-term glucose trends. The app also provides alerts if
your glucose is in or projected to be in an unsafe zone.
The GlucoMen Day CGM System allows you to:
•
Monitor your glucose by providing a new glucose rea-
ding every minute.
•
See how your glucose changes throughout the day and
night.
•
Receive alerts when something happens that requires
your attention, such as a low glucose reading.
IMPORTANT: • Children using this device should be as-
sisted by an adult. When the GlucoMen Day CGM system is
used by a child, a paired smart device with the app must
remain with the child.
• For use on children, it is recommended that you choose
a sensor insertion site that is least accessible to the child
to prevent manipulation by the child.
• When using the GlucoMen Day CGM, always carry a blo-
od glucose meter. There may be situations when you need
to perform a blood glucose test before making treatment
decisions. See SECTION 14.1 for details.
CAUTION
Please read all the instructions provided in this user guide
before using the system.
IMPORTANT: Illustrations in this guide are for instructio-
nal purposes only and are not shown at actual size.
The display of the GlucoMen Day CGM App may appear sli-
ghtly different depending on the smart device (Android or
iOS) on which the app is displayed. Images of the Gluco-
Men Day CGM App in this guide are for instructional pur-
poses only. When there is a significant difference between
the Android and iOS versions of the app, both screens are
shown. In all other cases, the Android version is used for
reference.
IMPORTANT: The GlucoMen Day CGM App supports
both units of measure for glucose: mg/dL and mmol/L.
Images in this guide are for instructional purposes only
and may not use the same units as your app.
1.2
Indications for use
The GlucoMen Day CGM is:
•
Intended for the management of diabetes.
•
Intended to replace fingerstick testing for making diabe-
tes treatment decisions. See CHAPTER 14 for limitations.
•
Intended for use in the abdomen and lower sides only.
•
Intended only for single patient use.
•
Intended as an aid in the detection of episodes of hyper-
glycaemia and hypoglycaemia, facilitating both acute and
long-term therapy adjustments.
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