WaveForm A.MENARINI diagnostics GlucoMen Day CGM User manual

User Guide

WaveForm Technologies
27700 SW 95th Ave Suite 100
Wilsonville, OR 97070
USA
MDSS GmbH
Schigraben 41
30175 Hannover
Germany
©2019 WaveForm Technologies Inc.
US and International Patents Pending. All rights reserved.
All trademarks and copyrights are the property of their
respective owners.
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Technologies Inc. is under licence. Other trademarks and trade names
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Play logo are trademarks of Google LLC.
SKIN-PREP™ is a trademark of Smith & Nephew.

English
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/Table of contents
/ 1 GlucoMen Day Continuous Glucose Monitoring System
1.1 Introduction
1.2 Indications for use
1.3 Getting started
/2Parts of the system
2.1 System overview
2.2 Sensor Assembly
/3Setting up the system
3.1 Download the app
3.2 Create an account
3.3 Log into an existing account
3.4 Connect a transmitter
/ 4 Inserting a sensor and starting a session
4.1 Prepare for sensor insertion
4.2 Choose a sensor insertion site
4.3 Clean the sensor insertion site
4.4 Select a transmitter
4.5 Activate the transmitter
4.6 Place the transmitter into the sensor assembly
4.7 Prepare the sensor insertion tool
4.8 Attach the sensor insertion tool to the sensor assembly
4.9 Remove the sensor adhesive liner
4.10 Apply the sensor assembly to the insertion site
4.11 Remove the sensor guide from the sensor insertion tool

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4.12 Wait for the sensor to stabilise
4.13 How will I know when to replace my sensor?
/ 5 Calibrating the system
5.1 When to calibrate
5.2 Entering a calibration reading
/ 6 Viewing continuous glucose readings
6.1 Navigating to the Home screen
6.2 Home screen overview
6.3 Current status
6.4 Trend chart
6.5 Estimated glucose
/ 7 Alerts
7.1 Navigating to the Alerts screen
7.2 Alerts screen overview
7.3 Allowing notifications
7.4 Setting up alerts
7.5 Alert status indicators
7.6 Glucose alerts
7.7 Devices alerts
7.8 Alert history
/ 8 Transmitters
8.1 Navigating to the Transmitters screen
8.2 Transmitters screen overview
8.3 Transmitters screen details
8.4 Charging a transmitter
8.5 Connecting a transmitter
8.6 Activating a transmitter

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8.7 Deleting a transmitter
/ 9 Meters
9.1 Navigating to the Meters screen
9.2 Meters screen overview
9.3 Connecting a meter
9.4 Deleting a meter
/ 10 Info
10.1 Navigating to the Info screen
10.2 Glucose overview report
10.3 CSV data report
10.4 Sensor insertion instructions
10.5 Sensor removal instructions
10.6 Icons and colours
10.7 FAQs
10.8 Comprehensive User Guide
10.9 Customer Service
10.10 Legal
/ 11 Profile
11.1 Navigating to the Profile screen
11.2 Changing personal information
11.3 Changing your country
11.4 Changing your email
11.5 Changing your password
11.6 Resetting your password
11.7 Email communication settings
11.8 Sharing data with WaveForm
11.9 Analytics

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/12 Stopping a session
12.1 Automatically stopping a session
12.2 Manually stopping a session
/13 Removing a sensor
/14 Limitations
14.1 When to use your blood glucose meter for treatment decisions
14.2 Travelling with your GlucoMen Day CGM
/15 Troubleshooting
15.1 Continuous glucose reading issues
15.2 Alert issues
15.3 Calibration issues
15.4 Sensor issues
15.5 Transmitter issues
15.6 Transmitter charger issues
15.7 Sensor insertion issues
/16 Additional information
16.1 Customer Service information
16.2 Cleaning your system
16.3 System disposal
16.4 Product specifications
16.5 Labelling symbols
16.6 Accuracy Summary
16.7 Electromagnetic compatibility
16.8 Warranty
/17 Glossary of terms

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GlucoMen Day Continuous Glucose Monitoring System /
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 uid. 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 dierent 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 signicant dierence
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 ngerstick 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.

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GlucoMen Day Continuous Glucose Monitoring System /
English
Limitations
• The GlucoMen Day CGM is not safe for use in magne-
tic resonance (MR) environments. Remove the GlucoMen
Day CGM (sensor and transmitter) before Magnetic Reso-
nance Imaging (MRI), Computed Tomography (CT) scan,
or high-frequency electrical heat (diathermy) treatment.
• Placement of the GlucoMen Day sensor is not approved
for sites other than the skin of the abdomen and lower
sides.
• Do not reuse the sensor or use it beyond 14 days.
• Inspect the sensor assembly sterile pouch prior to use.
Do not use the sensor assembly if the sterile pouch is
open or damaged.
• Do not wear the sensor in a hot tub.
• Do not swim with the transmitter and sensor in place
for longer than 30 minutes and at depths greater than
1 metre (3 feet).
• The GlucoMen Day CGM is not intended for use outside
of the transmitter operating temperature range of 5°C to
45°C (41°F to 113°F).
• The GlucoMen Day CGM System contains small parts
that may be a choking hazard.
CAUTION
The GlucoMen Day CGM System requires the use of a blo-
od glucose meter for calibration. Check your meter’s ow-
ner’s guide for additional restrictions.
1.3 Getting started
The GlucoMen Day CGM is designed to replace nger-
stick testing for making diabetes treatment decisions.
Before using the GlucoMen Day CGM to make treatment
decisions, it is important to understand how you can use
the information from your CGM. Your current glucose le-
vel, current glucose trend, and your past readings can all
be used to make informed decisions.
It is also important to know when you should not use
your CGM for treatment decisions and should instead
use your blood glucose meter.
You should work with your healthcare professional to de-
termine how to use the GlucoMen Day CGM to manage
your diabetes.
Important user information
The GlucoMen Day CGM sends a glucose reading once per mi-
nute and provides a trend arrow that shows the direction and
rate of change of your glucose. It’s important to un-
derstand where your glucose is and how it’s changing
(trending) rather than focusing only on individual CGM
readings. As you use your CGM, remember two important
things about trends:
• Trends highlight the direction in which your CGM glu-
cose levels are heading and the rate at which they are
changing. Trends can tell you if your glucose has been
rising, falling, or stable over several minutes or hours up
to the previous 24 hours.
• Understanding and adjusting your insulin levels based
on trends is more useful than a single CGM glucose rea-
ding. The CGM displays glucose levels from the intersti-
tial uid that surrounds the sensor, which is similar but
may vary from your actual glucose level.
CAUTION
Avoid exposing your GlucoMen Day CGM to insect repel-
lent and sunscreen. Contact with these skin care products
may cause damage to your CGM.

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Parts of the system /
English
/ 2
Parts of the system
2.1 System overview
The GlucoMen Day CGM uses a single-use, disposable
sensor inserted into interstitial uid that converts gluco-
se levels into an electrical signal. The sensor is located
within the sensor assembly, which includes the sensor,
sensor adhesive patch, and sensor guide. A recharge-
able transmitter attaches to the sensor assembly, which
is secured to the skin with the adhesive patch. The tran-
smitter sends the glucose readings to the GlucoMen Day
App using
Bluetooth
®
low energy technology.
CAUTION
• Check the expiration date on the pouch before using.
• Do not modify any part of the GlucoMen Day CGM or
use components other than those specied in this guide.
• The GlucoMen Day CGM System contains small parts
that may be a choking hazard.
IMPORTANT: If you do not have SKIN-PREPTM wipes,
you can use an alcohol wipe.
IMPORTANT: The transmitter and sensor adhesive
patch can be worn while bathing and showering. You can
also swim with the transmitter and sensor in place up to
a depth of 1 metre (3 feet) for up to 30 minutes.
If you do not have an overpatch, you can use medical
tape around the edges of the adhesive patch.
CAUTION
CAUTION
• Do not use the sensor assembly if the sterile pouch is
open or damaged. Do not handle the sensor assembly
until you are ready to insert the sensor because the sen-
sor can become contaminated.
• Do not wear the sensor in a hot tub.
Do not throw away the transmitter, the sensor insertion tool,
or the transmitter charger when you dispose of the sensor.
The transmitter is intended to be recharged and used again.
Sensor Assembly Transmitter Sensor Insertion Tool
Transmitter
Charger
SKIN-PREPTM
Wipe
Overpatch App
/ 2.2 Sensor Assembly

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Setting up the system /
English
/ 3
Setting up the system
3.1 Download the app
The GlucoMen Day App serves as the display for the Glu-
coMen Day CGM and supports Android and iOS devices
(smart devices). The app is available on Google Play (An-
droid) and the App Store (iOS). To see a list of compatible
smart devices, visit www.menarinidiagnostics.com.
IMPORTANT: The app stores sensitive health-related
information on your smart device. It is recommended to
keep your smart device up-to-date with the latest secu-
rity software. For details on updating your smart device
and keeping your information safe, contact the manu-
facturer of your smart device.
CAUTION
Do not install the app on
a smart device that has
been jailbroken or roo-
ted. Doing so may com-
promise the security and
functionality of the app.
3.2 Create an account
Before using the GlucoMen Day CGM App, you need to
answer a few simple questions and create an account.
Your account will be used to store all of your CGM data.
You can always update your information under PROFILE
(CHAPTER 11).
IMPORTANT: The country you select determines the
glucose units used in the app (mg/dL or mmol/L).
NOTE: If your app only supports one country, you will not
see the COUNTRY screen.
4.
Read the DISCLAIMER and
tap I UNDERSTAND.
5.
Select your Country and
tap the ( ) icon.
Enter your First and Last
Name and tap the ( ) icon.
Select your Birth year and
tap the ( ) icon.
Select your Gender and tap
the ( ) icon.
Select Type of diabetes and
tap the ( ) icon.
IMPORTANT: If you do not have an overpatch, you
can use medical tape around the edges of the adhesive
patch.
1.
Tap the GlucoMen Day
CGM App icon to open
the app.
2.
Tap SIGN UP.
3.
Tap GET STARTED.

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Setting up the system /
English
6.
Read the explanation of why
notications are important
and tap the ( ) icon.
Enter your email and create
a password.
At the bottom of the
agreement, choose a sharing
option and tap CONFIRM.
On Android: If you see a
message asking for DO NOT
DISBURB access, tap GO TO
SETTINGS and follow the
prompts to enable permissions
so that you don’t miss any
alerts.
7.
Choose your email
communication settings.
Passwords must be at least
8 characters.
NOTA: Tap the ( ) icon to
show or hide your password.
8.
Read and agree to the
PRIVACY POLICY and tap
SIGN UP.
9.
Review the CONSENT TO
DATA PROCESSING BY
WAVEFORM to decide if you
want to consent to sharing
data.
On iOS: If you see a message asking for permission to send
notications, tap ALLOW so that you don’t miss any alerts.
/ 3.3 Log into an existing account
If you already have an account for the GlucoMen Day
CGM App, you can log in to your existing account.
1.
Tap the GlucoMen Day
CGM App icon to open
the app.
2.
Tap LOG IN.
3.
Enter your email and
password.
4.
Tap LOG IN.
If you forgot your password,
see SECTION 11.6 for steps
to reset your password.
NOTA: Tap the ( ) icon to
show or hide your password.

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3
A
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Setting up the system /
English
3.
Open the app:
1. Tap the DEVICES button. On An-
droid devices you may need to tap
the BACK ARROW until you see the
bottom buttons.
2. Tap TRANSMITTERS.
3. On Android: Tap the (+) button.
On iOS: Tap ADD A NEW TRAN-
SMITTER.
3.4 Connect a transmitter
The GlucoMen Day CGM Devices kit includes two transmit-
ters so that you can use one while charging the other.
The transmitters communicate with the GlucoMen Day App
using Bluetooth and must be connected to the app before
they can be used. This process is also called
pairing .
IMPORTANT: • Your transmitter communicates with
the app using Bluetooth wireless technology. Your smart
device must have Bluetooth turned on to continue.
• Read all pairing instructions before attempting to
pair your transmitter. Once you press the button on the
charger, the transmitter will be in pairing mode for 60
seconds. If you are unable to successfully pair the tran-
smitter during this time, you will need to restart the pai-
ring process.
CAUTION
You can only connect a transmitter to one smart devi-
ce at a time. If you connect the transmitter to a second
smart device, it will no longer be connected to the rst
smart device.
IMPORTANT: If this is the
rst time you have connected
a transmitter, the app will di-
splay hints to point out the
next step and highlight im-
portant features. When you
are done reading the hints,
tap OK.
1.
Locate the 6-digit numeric PIN (A)
on the bottom of the transmitter.
Record the 6-digit numeric PIN,
which you will need in step 7.
2.
Place the transmitter in the char-
ger and connect to a power source.
Keep the transmitter in the charger
until pairing is complete.
The light on the charger may ash
red for up to 5 seconds. Make sure
the light has turned green (ashing
if not fully charged or solid if fully
charged) before starting step 3.
See SECTION 8.4 for details about
charging the transmitter.

A
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Setting up the system /
English
9.
If this is the rst transmitter you
have connected, you will see a
message asking if you want to con-
nect your second transmitter.
• If you tap YES, repeat steps 1-7
with the second transmitter.
• If you tap NO, follow steps 1-7
when you are ready to pair.
IMPORTANT: If more than one
transmitter is connected, a mes-
sage will appear indicating that
another transmitter is already acti-
ve. Only the active transmitter can
be used for a session.
See SECTION 8.6 for details about
activating a transmitter.
4.
On Android devices only:
Depending on your device’s per-
mission settings, you may see any
or all of these messages on the
NEW TRANSMITTER screen:
• Allow this app to access your lo-
cation.
• Turn on location.
• Allow Bluetooth.
CAUTION
All of these permissions must be enabled to connect to
a transmitter.
5.
Press the button on the charger.
A ashing blue light indicates the
transmitter is ready to pair.
NOTE: Once you press the button
on the charger, the transmitter will
be in pairing mode for 60 seconds.
6.
On the NEW TRANSMITTER scre-
en, select your transmitter when it
appears in the list.
If multiple transmitters are listed,
check the 7-digit alphanumeric ID
(A) on the top of your transmitter
to make sure you select the correct
transmitter.
7.
When the Bluetooth Pairing Reques t appears, enter the 6-digit
numeric PIN that you recorded in step 1.
Tap PAIR.
8.
The app indicates that the transmitter is connecting.
Once pairing is complete, your paired transmitter will be listed un-
der AVAILABLE TRANSMITTERS on the TRANSMITTERS screen.
You can now use this transmitter to start a CGM session.
Home screen: Transmitters screen:
If any of these messages appear, tap the message and follow the
prompts to enable permissions.

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Inserting a sensor and starting a session /
English
Right side Front Left side
It is best to avoid choosing a site in the following
areas:
• On your midline (the vertical line through your navel).
• In areas that become creased or folded when you move
(such as along the waistline).
• In areas that are heavily scarred.
• In areas that have a rash or other skin irritation.
• In areas where clothing, belts, or seat belts may rub
and irritate.
CAUTION
•Check the expiration date on the sensor assembly pou-
ch. If the sensor has expired, do not use it. Using an expi-
red sensor may result in inaccurate glucose readings.
•Follow the sensor insertion instructions carefully. Fai-
lure to do so may result in accidental deployment of the
sensor.
•There are several moving parts on the bottom of the
sensor insertion tool. These may pinch your ngers if you
do not follow the instruction for preparing and using the
sensor insertion tool.
4.2 Choose a sensor insertion site
Before you insert the sensor, take a moment to consider
where the best insertion site may be.
Choose a sensor insertion site on your abdomen or
lower side that:
• Is easy to reach also out of the way of tight clothing
and belts.
• Is at least 4 cm (1.5 inches) from an insulin injection
site or insulin pump, measured from the edge of the
adhesive patch.
• Is smooth. If needed, shave the area to allow the adhe-
sive patch to stick to the skin.
/ 4 Inserting a sensor
and starting a session
4.1 Prepare for sensor insertion
To start a CGM session, you must insert a sensor. The
insertion process should be done in a clean, dry place.
Wash and dry your hands before beginning.
To prepare for sensor insertion, gather the following parts:
• Sensor insertion tool
• Sealed sensor assembly pouch
• Fully charged and paired transmitter (see SECTION 8.4
for details about charging the transmitter and SECTION
3.3 for details about pairing the transmitter)
•SKIN-PREP™ wipes (optional)
• Overpatch (optional)
• GlucoMen Day app (see SECTION 3.1 for instructions to
download the app)

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Inserting a sensor and starting a session /
English
4.4 Select a transmitter
Identify the transmitter you want to use. Make sure the
transmitter is fully charged by placing it in the charger
and checking that the light on the charger is solid green.
See SECTION 8.4 for details about charging the tran-
smitter.
CAUTION
•If the transmitter is not fully charged, the app will display
a message at the start of the session, that lets you know
the transmitter might not last for the full 14-day session.
You cannot switch transmitters in the middle of a session.
If the transmitter battery dies, you will need to insert a new
sensor to start a new session.
• Check the transmitter for any visible defects, such as
cracks. Do not use the transmitter if you see any defects.
CAUTION
•You should only insert the sensor on your abdomen
or lower side, roughly between your ribs and beltline.
Ask your healthcare professional about the best sensor
insertion site for you. Bleeding, swelling, bruising, or in-
fection at the sensor insertion site are possible risks of
sensor use. If any of these conditions occur, get treat-
ment advice from your healthcare professional.
• You should choose a new insertion site every time you
insert a new sensor. Using the same site may cause irri-
tation at the insertion site.
4.3 Clean the sensor insertion site
Clean the chosen insertion site before inserting the sen-
sor. Careful cleaning of the insertion site disinfects the
skin and helps the sensor adhesive patch to stick tightly
to your skin.
CAUTION
•Do not allow anything to touch the insertion site after
cleaning and before you insert the sensor.
• The insertion site must be dry before applying a SKIN-
PREPTM wipe and MUST be completely dry before inser-
ting the sensor.
• Failure to clean the insertion site, or improper cleaning
technique may result in an infection.
1.
Remove the SKIN-PREP™ wipe from its sealed package.
If you do not have a SKIN-PREP™ wipe, use an alcohol wipe.
2.
Place the wipe on the insertion
site and wipe in a circular pattern
outward, away from that spot.
Continue cleaning until you have
cleaned the area about 15-20 cm
(6-8 inches) across without re-
turning to any areas you already
cleaned.
3.
Allow the cleaned area to dry completely, for two minutes.
CAUTION
Keep clothing from touching the cleaned area.

C
C
AA
B
B
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Inserting a sensor and starting a session /
English
CAUTION
Avoid touching the transmitter contacts, located betwe-
en the transmitter arms.
5.
Hold the transmitter, with the arms pointing down, perpendicular
to the sensor assembly.
The side of the transmitter with the ID (C) should face the wide
end of the sensor assembly.
4.5 Activate the transmitter
Although you can connect multiple transmitters to the
app, only one transmitter can send CGM readings to the
app at a time. That transmitter is referred to as the acti-
ve transmitter.
See SECTION 8.6 how to activate a transmitter.
4.6 Place the transmitter into the
sensor assembly
To complete these steps, you will need the active tran-
smitter and the sensor assembly.
2.
Remove the sensor assembly from
the inner tray.
CAUTION
Do not peel o the protective paper on the sensor as-
sembly until immediately before insertion.
1.
Remove the sensor assembly from
the sterile pouch.
3.
Set the sensor assembly on a hard, clean surface (such as the inside
of the sterile pouch) with the sensor adhesive patch facing down.
4.
Locate the transmitter arms (B).

B
B
A
A
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Inserting a sensor and starting a session /
English
2.
Locate the tab (B) on the sensor insertion tool at the end with
the lever (1 bump).
4.7 Prepare the sensor insertion tool
Now that you have inserted the transmitter into the sen-
sor assembly, you can prepare the sensor insertion tool.
To complete these steps, you will need the sensor inser-
tion tool.
1.
Place the sensor insertion tool on a
hard, clean surface.
Locate the plastic lever (with 1
bump) (A) on the sensor insertion
tool.
2.
Lift this lever up until you hear a
click, then lower to its starting po-
sition. An orange tab indicates that
the sensor insertion tool is ready
to use.
4.8 Attach the sensor insertion tool
to the sensor assembly
Next, attach the sensor insertion tool to the sensor as-
sembly.
1.
Set the sensor assembly on a hard,
clean surface (such as the inside of
the sterile pouch) with the sensor
adhesive patch facing down.
Locate the opening (A) at the wide
end of the sensor assembly.
6.
Lower the transmitter and steer the arms into the guide slots of
the sensor assembly.
Guide slots:
7.
Tilt the curved end of the transmit-
ter downward to meet the sensor
assembly.
8.
Press the transmitter down rmly
until it snaps into place and you
hear a click.

B
A
A
B
16
Inserting a sensor and starting a session /
English
3.
Grip the left tab and peel it back to
remove the second section of the
liner.
Make sure the adhesive does not
fold onto itself before or during
application.
3.
Hold the sensor insertion tool, with
the tab (B) pointing down, perpen-
dicular to the sensor assembly.
Align the tab directly above the
opening (A) on the sensor assem-
bly.
NOTE: The sensor assembly ope-
ning (A) is for alignment and po-
sitioning of sensor insertion tool
tab (B).
4.
Lower the sensor insertion tool,
steering the tab into the opening
on the sensor assembly.
5.
Tilt the raised end of the sensor in-
sertion tool downward to meet the
sensor assembly, until you hear a
click.
6.
The sensor insertion tool and sensor guide should snap together
without a gap.
Check for a gap between the sensor insertion tool and sensor
guide. If there is a gap, see SECTION 15.7.
4.9 Remove the sensor adhesive liner
Once you have cleaned the insertion site, you are rea-
dy to remove the liner on the sensor adhesive patch. To
complete this step, you need the sensor insertion tool
with the sensor assembly attached.
CAUTION
The adhesive is sterile; do not touch the centre of the
adhesive material. Only touch the perimeter of the adhe-
sive when removing the liner.
1.
Hold the sensor insertion tool with
the sensor adhesive liner facing
up.
Locate the tabs (A and B) on each
side of the liner.
2.
Grip the right tab and peel it back
to remove the rst section of the
liner.

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Inserting a sensor and starting a session /
English
CAUTION
• If the transmitter was not fully charged, a message lets
you know that the transmitter might not last for the full
14-day session. You cannot switch transmitters in the
middle of a session. If the transmitter battery dies, you
will need to remove the sensor and insert a new sensor to
start a new session.
• Do not remove the transmitter while the sensor assembly
is attached to you.
• If you feel resistance when removing the sensor insertion tool
with two separate sensor assemblies, call Customer Service.
IMPORTANT: The CGM session starts automatically when the
sensor is inserted.
3.
Press the insertion button (2 bumps) until you hear a click. Con-
tinue holding the sensor insertion tool in place.
Do not try to adjust the placement of the adhesive patch after
application.
4.
While holding the sensor insertion tool in place, press the release
button (3 bumps) until you hear a click.
5.
Carefully lift the sensor insertion tool away from your body, in a
straight outward motion.
If you feel resistance, repeat steps 4-5.
IMPORTANT: The sensor guide remains connected to the
sensor insertion tool, leaving only the transmitter, sensor, and
adhesive patch on your body.
6.
Smooth the sensor adhesive patch to make sure it is fully adhe-
red to your skin. Gently smooth out any wrinkles around the ed-
ges to make sure there are no gaps.
4.10 Apply the sensor assembly
to the insertion site
Now that you have removed the liner on the sensor adhe-
sive patch, you are ready to apply the patch to your skin.
CAUTION
Failure to follow insertion instructions carefully may
cause the sensor to slide along the skin instead of in-
serting into the skin. If this occurs, the session may not
start or the sensor will provide low-quality data, which
will not be displayed in the app. Follow the instructions
carefully to ensure proper sensor insertion.
1.
Holding the sensor insertion tool,
place the adhesive patch rmly on
the insertion site, parallel to your
beltline.
Point the release button (3 bumps)
on the sensor insertion tool toward
your navel.
2.
Press down rmly to ensure the adhesive patch is secured to
your skin. Then apply normal pressure to your skin during in-
sertion.

18
Inserting a sensor and starting a session /
English
4.12 Wait for the sensor to stabilise
Once you have inserted a new sensor, you must wait ap-
proximately 45 minutes for the sensor to stabilise before
you can calibrate the system. While the sensor is stabi-
lising, the app will display a progress bar and number
of minutes until calibration within the HOME screen and
TRANSMITTERS screen.
Home screen: Transmitters screen:
Once the sensor has stabilised, it is time to calibrate. If
you have allowed the app to send notications and have
turned on the calibration alert, you will receive a notica-
tion that it is time to calibrate. See CHAPTER 7 for details
about alerts.
The HOME screen and TRANSMITTERS screen will indi-
cate that it is time to calibrate. See CHAPTER 5 for de-
tails about calibration.
Home screen: Transmitters screen:
Once you have inserted a new sensor, it may take 1-3
minutes for the app to detect the sensor.
NOTE: If the edges of the adhesive patch begin to peel
up at any time during your session, you may apply the
overpatch. See SECTION 15.7 for instructions on how to
apply the overpatch.
4.11 Remove the sensor guide from
the sensor insertion tool
After you insert the sensor, you need to remove the sen-
sor guide from the sensor insertion tool, so you can use
the sensor insertion tool the next time you insert a sen-
sor.
1.
Locate the release tab on the bot-
tom of the sensor insertion tool.
Press and hold the release tab.
2.
While pressing up on the release
tab, pull back on the sensor guide.
3.
Discard the used plastic sensor guide.
Store the reusable sensor insertion tool with the other supplies
for your GlucoMen Day CGM.
4.13 How will I know when
to replace my sensor?
The sensor is designed to work for 14 days. After 14
days, the app will let you know that the session has en-
ded, and the sensor needs to be replaced.