Abbott FreeStyle Libre 3 User manual

User's Manual | Manual del usuario
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ART42490-004_rev-B 4:05pm 03-May-2023

User's Manual
App Symbols
App icon
Alarms you have turned on are
unavailable
Scan New Sensor/Start New Sensor
Direction your glucose is going. See
Understanding Your Glucose
Readings for more information.
Caution
Add/edit notes
Food note
Insulin (Rapid or Long-acting) note
Alarm
Exercise note
Time change
Main menu
Multiple/Custom notes
⚌
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Share report (iOS)
Share report (Android)
Additional information
Calendar
Sensor too cold
Sensor too hot
Important Information
Indications for Use
FreeStyle Libre 3 app (‘App’) when used with a FreeStyle Libre 3 Continuous Glucose
Monitoring System Sensor (‘Sensor’) is indicated for measuring interstitial fluid
glucose levels in people (age 4 and older) with diabetes mellitus, including
pregnant women. The App and Sensor are designed to replace blood glucose
testing in the self-management of diabetes, including dosing of insulin.
The indication for children (age 4–12) is limited to those who are supervised by a
caregiver who is at least 18 years of age. The caregiver is responsible for managing
or assisting the child to manage the App and Sensor and also for interpreting or
assisting the child to interpret Sensor glucose readings.
Compatible Devices, Apps and Software
For a list of compatible devices, apps and software that can be used with the
FreeStyle Libre 3 Sensor, please go to:
www.FreeStyleLibre.com
Use of the Sensor with devices, apps and software that are not listed may cause
inaccurate glucose readings.
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WARNINGS
If you are using the FreeStyle Libre 3 app, you must also have access to a blood
glucose monitoring system as the App does not provide one.
CAUTION:
The FreeStyle Libre 3 app installed on a phone is intended for use by a single
person. It must not be used by more than one person due to the risk of
misinterpreting glucose information.
For you to receive alarms, make sure to:
Turn alarms ON and ensure that your phone is within 10 metres (33ft) of you
at all times. The transmission range is 10 metres (33ft) unobstructed. If you
are out of range, you may not receive alarms. If you want to receive the App's
optional alarms, make sure these are turned on.
Do not force close the App. The App must be running in the background to
receive alarms. If you force close the App you will not receive alarms. Re-open
the App to ensure you will receive alarms.
If you restart your phone, open your App to make sure it’s working properly.
The App will ask for phone permissions which are needed to receive alarms.
Allow these permissions when requested.
Check to make sure that you have the correct phone settings and permissions
enabled. If your phone is not configured properly, you will not receive alarms.
iPhones are to be configured as follows:
In the phone settings, ensure Bluetooth is ON
In the phone settings for the App, allow the App to access Bluetooth
In the phone settings for the App under notifications
Keep Allow Critical Alerts ON
Keep Allow Notifications ON
Keep Lock Screen and Banner alerts ON
Keep sounds ON
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If you adjust the phone ringer volume to silent or use the phone do not
disturb setting, turn ‘Override Do Not Disturb’ setting in the App ON for
Low Glucose, High Glucose, and Signal Loss Alarms to ensure you receive
audible alarms.
Note: You must accept the App’s permission request for Critical Alerts to
use the Override Do Not Disturb feature. You can also enable the Critical
Alerts setting directly from the App's notification settings.
Android phones are to be configured as follows:
In the phone settings
Keep Bluetooth ON
Keep phone Media volume ON
Keep Battery Saver mode OFF
In the phone settings for the App
Keep Show Notifications ON
Keep Do Not Disturb access permission ON
Keep Battery Optimisation OFF
Keep Nearby Devices permission ON (For Android 12 and above)
Keep Alarms and Reminders permission ON (For Android 12 and
above)
Do NOT modify channel notification settings for the App
Keep Lock Screen notifications ON
Keep Pop-up notifications ON
You may need to add the FreeStyle Libre 3 app to the list of apps that will
not be restricted or put to sleep.
If you adjust the phone Media volume to silent or use the phone do not
disturb setting, turn ‘Override Do Not Disturb’ setting in the App ON for
Low Glucose, High Glucose, and Signal Loss Alarms to ensure you receive
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audible alarms.
Note: You must accept the App’s permission request for Do Not Disturb
access to use the Override Do Not Disturb feature. You can also enable the
Do Not Disturb access setting directly from the App's notification settings.
You should disconnect headphones or speakers from your phone when you
are not using them as you may not hear audio for alarms. If using
headphones, keep them in your ears.
If you are using peripheral devices connected to your phone, such as wireless
headphones or a smartwatch, you may receive alarms on only one device or
peripheral, not all.
Keep your phone well charged and turned on.
Disable your phone’s automatic operating system updates. After an operating
system update, open your App and check your device settings to make sure
it’s working properly.
Some operating system features may impact your ability to receive alarms.
For example, if you use an iPhone and the iOS Screen Time feature, add
FreeStyle Libre 3 to the list of always allowed apps to ensure that you receive
alarms or if you use an Android phone do not use the Android Digital
Wellbeing app.
Security Information
You are responsible for properly securing and managing your phone. If you
suspect an adverse cybersecurity event related to the FreeStyle Libre 3 app,
contact Customer Service.
Make sure that your phone and Sensor kit are kept in a safe place, under your
control. This is important to help prevent anyone from accessing or tampering
with the System.
The FreeStyle Libre 3 app is not intended for use on a phone that has been
altered or customised to remove, replace or circumvent the manufacturer’s
approved configuration or use restriction, or that otherwise violates the
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manufacturer’s warranty.
The following Contraindication, Warnings and other safety information apply
to the Sensor, when used with the FreeStyle Libre 3 app.
CONTRAINDICATION: The Sensor must be removed prior to Magnetic Resonance
Imaging (MRI).
WARNING: Do not ignore symptoms that may be due to low or high blood
glucose. If you have symptoms that do not match the Sensor glucose reading, or
suspect your reading may be inaccurate, check the reading by conducting a
fingerstick test using a blood glucose meter. If you are experiencing symptoms
that are not consistent with your glucose readings, consult your healthcare
professional.
CAUTION:
The Sensor contains small parts that may be dangerous if swallowed.
On rare occasions, you may get inaccurate Sensor glucose readings. If you
believe your readings are not correct or are inconsistent with how you feel,
perform a blood glucose test on your finger to confirm your glucose and check
to make sure your Sensor has not come loose. If the problem continues or if
your Sensor is coming loose, remove the current Sensor and apply a new one.
Intense exercise may cause your Sensor to loosen due to sweat or movement of
the Sensor. If your Sensor comes loose, you may get no readings or unreliable
readings, which may not match how you feel. Follow the instructions to select an
appropriate application site.
Some individuals may be sensitive to the adhesive that keeps the Sensor
attached to the skin. If you notice significant skin irritation around or under your
Sensor, remove the Sensor and stop using the Sensor. Contact your healthcare
professional before continuing to use the Sensor.
Performance of the Sensor when used with other implanted medical devices,
such as pacemakers, has not been evaluated.
Do not reuse Sensors. The Sensor and Sensor Applicator are designed for single
use. Reuse may result in no glucose readings and infection. Not suitable for re-
sterilisation. Further exposure to irradiation may cause inaccurate results.
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Additional Safety Information
Physiological di"erences between the interstitial fluid and capillary blood may
result in di"erences in glucose readings. Di"erences in Sensor glucose readings
between interstitial fluid and capillary blood may be observed during times of
rapid change in blood glucose, such as after eating, dosing insulin or exercising.
Store the Sensor Kit between 2°C and 28°C. While you don’t need to keep your
Sensor Kit in a refrigerator, you can as long as the refrigerator is between 2°C
and 28°C.
If you have a medical appointment that includes strong magnetic or
electromagnetic radiation – for example an X-ray, MRI (Magnetic Resonance
Imaging) or CT (Computed Tomography) scan – remove the Sensor you are
wearing and apply a new one after the appointment. The e"ect of these types of
procedures on the performance of the Sensor has not been evaluated.
The Sensor has not been evaluated for use in persons on dialysis or people less
than 4 years of age.
The Sensor Applicator is sterile unless opened or damaged.
Your Sensor has been tested to withstand immersion into one metre (3 ft) of
water for up to 30 minutes. It is also protected against insertion of
objects>12mm diameter. (IP27)
Do not freeze the Sensor. Do not use if expiry date has passed.
FreeStyle Libre 3 app Overview
IMPORTANT: Read all of the information in this User’s Manual before using the
FreeStyle Libre 3 app with a Sensor. Refer to your phone’s instructions for use for
how to use your phone.
The FreeStyle Libre 3 app is available for download from the App Store or Google
Play Store. When you’re ready to start using the FreeStyle Libre 3 system, you’ll
prepare and apply a Sensor to the back of your upper arm. You can then use the
App to get glucose readings from the Sensor and store your glucose history and
notes. The Sensor comes in a Sensor Kit and can be worn on your body for up to
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14 days.
Note: The FreeStyle Libre 3 app is only compatible with certain mobile devices and
operating systems. Please check www.FreeStyleLibre.com for more information
about device compatibility before upgrading your phone or its operating system.
Home Screen
The Home Screen displays your current glucose, glucose trend arrow and glucose
graph. It is automatically updated every minute with glucose data from the Sensor.
To return to the Home Screen from another screen, go to the Main Menu and tap
Home.
Main Menu – Tap to access the Home Screen, Alarms, Logbook, other history
options and Connected Apps. You can also access Settings, Help and other
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information
Message – You may be able to tap the message for more information
Alarms Unavailable – The displays if alarms you have turned on are not
available
Current Glucose – Your most recent glucose value
Glucose Trend Arrow – Direction your glucose is going
Glucose Graph – Graph of your current and stored glucose readings
Target Glucose Range – The graph shows your target glucose range. This is not
related to glucose alarm levels
High Glucose Alarm Level – The graph shows your High Glucose Alarm level. This
displays only when you have turned the alarm ON
Low Glucose Alarm Level – The graph shows your Low Glucose Alarm level. This
displays only when you have turned the alarm ON
Sensor Life – The number of days of life remaining on the Sensor
Add Note – Tap to add notes to the glucose reading
Note Symbol – Tap to review notes you’ve entered
Reporting Software
Software can be used to create reports based on glucose readings from FreeStyle
Libre 3 Sensors. Go to www.FreeStyleLibre.com and follow onscreen instructions to
access the compatible software. You are responsible for keeping your computer
secure and up to date; for example, by using anti-virus software and installing
system updates.
Sensor Kit
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A FreeStyle Libre 3 Sensor Kit includes:
Sensor Applicator
Product insert
When opening your kit, check that the contents are undamaged and that you have
all parts listed. If any parts are missing or damaged, or if the tamper label
indicates the Sensor Applicator has already been opened, contact Customer
Service. The Sensor (only visible after applied) measures and stores glucose
readings when worn on your body. By following the instructions, you use the
Sensor Applicator to apply the Sensor on the back of your upper arm. The Sensor
has a small, flexible tip that is inserted just under the skin.
Sensor Applicator. Applies the Sensor to your body.
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App Setup
The FreeStyle Libre 3 app is only compatible with certain mobile devices and
operating systems. Please check www.FreeStyleLibre.com for more information
about device compatibility before upgrading your phone or its operating system.
Before using the App for the first time, you must complete the setup.
1. Check that your phone is connected to a network (Wi-Fi or mobile). You can then
install the FreeStyle Libre 3 app from the App Store or Google Play Store. Tap
the App icon to open the App.
Note: You only need to be connected to a network for setup, using LibreView
and sharing with other apps. You do not need to be connected to check your
glucose, receive alarms, add notes or review your history in the App.
2. Swipe left to view some helpful tips or tap GET STARTED NOW at any point. If
you already have a LibreView account, tap Sign In.
3. Confirm your country and tap NEXT.
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4. You have the option to create a LibreView account so that you can:
View your data and reports online at www.LibreView.com
Share your data with your care team through Connected Apps
Connect your Sensor to your account, allowing you to transfer it to a di"erent
phone (for instance, if you lose your phone)
Follow onscreen instructions to review legal information.
5. Confirm your glucose unit of measure and tap NEXT.
6. Select how you count carbohydrates (in grams or portions) and tap NEXT. The
carbohydrate unit will be used in any food notes you enter in the App.
7. The App now displays some useful information. Tap GET STARTED NOW then
tap NEXT to review each screen.
8. Accept required notification permissions.
9. Apply a new Sensor and then tap NEXT. Go to Starting Your Sensor.
Note: If you need help applying your Sensor, tap HOW TO APPLY A SENSOR or
go to Applying Your Sensor.
Applying Your Sensor
CAUTION:
Intense exercise may cause your Sensor to loosen due to sweat or movement of
the Sensor. If your Sensor comes loose, you may get no readings or unreliable
readings, which may not match how you feel. Follow the instructions to select an
appropriate application site.
Note: Tap Help in the Main Menu to access an in-app tutorial on applying a Sensor.
1. Apply the Sensor only on the back of your upper arm. Avoid areas with scars,
moles, stretch marks or lumps. Select an area of skin that generally stays flat
during your normal daily activities (no bending or folding). Choose a site that is
at least 2.5 cm (1 inch) away from an insulin injection site. To prevent discomfort
or skin irritation, you should select a di"erent site other than the one most
recently used.
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2. Wash application site using a plain soap, dry, and then clean with an alcohol
wipe. This will help remove any oily residue that may prevent the Sensor from
sticking properly. Allow site to air-dry before proceeding.
Note: The area MUST be clean and dry, or the Sensor may not stick to the site.
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3. Unscrew the cap from the Sensor Applicator and set the cap aside.
CAUTION:
Do NOT use if damaged or if tamper label indicates Sensor Applicator has
already been opened.
Do NOT put cap back on as it may damage the Sensor.
Do NOT touch inside Sensor Applicator as it contains a needle.
Do NOT use if past expiry date.
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4. Place the Sensor Applicator over the prepared site and push down firmly to
apply the Sensor to your body.
CAUTION: Do NOT push down on Sensor Applicator until placed over prepared
site to prevent unintended results or injury.
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5. Gently pull the Sensor Applicator away from your body. The Sensor should now
be attached to your skin.
Note: Applying the Sensor may cause bruising or bleeding. If there is bleeding
that does not stop, remove the Sensor, and apply a new one at a di"erent site.
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6. Make sure Sensor is secure after application. Put the cap back on the Sensor
Applicator. Discard used Sensor Applicator. See Disposal.
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Starting Your Sensor
Start a new Sensor by scanning it with your phone.
IMPORTANT:
The App requires that your phone has the correct date and time for recording
your health information. Your phone’s date and time should be set to update
automatically. You can check this in your phone settings.
When using the App, you should keep your phone well charged and be sure you
have access to a blood glucose monitoring system.
iPhone: The NFC (Near Field Communication) antenna is on the top edge of the
phone. Scan your Sensor by touching the Sensor with the TOP of your phone.
Move your phone around slowly if needed. Proximity, orientation, and other
factors can a"ect NFC performance. For example, a bulky or metallic case can
interfere with the NFC signal. Keep in mind that the ease of scanning a Sensor
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