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5
GlucoMen Day Continuous Glucose Monit
oring Sy
s
tem
/
English
/ 1
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,
inserted 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 pro-
vides 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
: When using the GlucoMen Day CGM,
always carry a blood glucose meter. There may be si-
tuations 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 gui-
de before using the system.
IMPORTANT
:
Illustrations in this guide are for in-
structional purposes only and are not shown at actual
size.
The display of the GlucoMen Day CGM App may appear
slightly different depending on the smart device (Android
or iOS) on which the app is displayed. Images of the Glu-
coMen Day CGM App in this guide are for instructional
purposes 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 ver-
sion 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 in adults,
children aged 6 and older, pregnant women, persons on
dialysis and persons who are critically ill.
•
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
hyperglycaemia and hypoglycaemia, facilitating both
acute and long-term therapy adjustments.