User’s Manual

CONTINUOUS GLUCOSE MONITORING SYSTEM

FreeStyle Libre 3 app

CAUTION: Federal law restricts this device to

sale by or on the order of a physician.
Your Name _________________________________________________
WARNING:
Before you use the FreeStyle Libre 3 System, review all the product
instructions and the Interactive Tutorial. The Quick Reference
Guide and Interactive Tutorial give you quick access to important
aspects and limitations of the System. The User’s Manual includes
all safety information and instructions for use. Talk to your health
care professional about how you should use your Sensor glucose
information to help manage your diabetes.
Failure to use the System according to the instructions for use
may result in you missing a severe low blood glucose or high
blood glucose event and/or making a treatment decision that
may result in injury. If your glucose alarms and readings from the
System do not match symptoms or expectations, use a fingerstick
blood glucose value from a blood glucose meter to make diabetes
treatment decisions. Seek medical attention when appropriate.
Important Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Contents
Indications For Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Compatible Devices, Apps, and Software . . . . . . . . . . . . . . . . . . 2
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Cautions and Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Interfering Substances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Reader Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
App Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Getting to Know Your System . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Sensor Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Reader Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
FreeStyle Libre 3 app . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Reader Home Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
App Home Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Reporting Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Setting up Your System for the First Time . . . . . . . . . . . . . . 30
Reader Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
App Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Applying Your Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Starting Your Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Starting Your Sensor with the Reader . . . . . . . . . . . . . . . . . . . . . 41
Starting Your Sensor with the App . . . . . . . . . . . . . . . . . . . . . . . 43
iPhone Users . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Android Phone Users . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Checking Your Glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Checking Your Glucose with the Reader . . . . . . . . . . . . . . . . . 48
Checking Your Glucose with the App . . . . . . . . . . . . . . . . . . . . 50
Understanding Your Glucose Readings . . . . . . . . . . . . . . . . . . . 54
Making Treatment Decisions . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Making Treatment Decisions – Getting Started . . . . . . . . . . . 59
Using Your Glucose Reading to Make a
Treatment Decision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Reader Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Setting Reader Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
Setting Reader Alarm Sounds . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Using Reader Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
App Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
Setting App Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
Using App Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .107
Adding Notes to Glucose Readings . . . . . . . . . . . . . . . . . . . 111
Adding Notes in the Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Adding Notes in the App . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Reviewing Your History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .115
Reviewing Your History in the Reader . . . . . . . . . . . . . . . . . . .115
Reviewing Your History in the App . . . . . . . . . . . . . . . . . . . . . .121
Removing Your Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
Replacing Your Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
Using Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .127
Using Reminders in the Reader . . . . . . . . . . . . . . . . . . . . . . . . .127
Using Reminders in the App . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
Using the Reader’s Built-in Meter . . . . . . . . . . . . . . . . . . . . .131
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
Blood Glucose Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .135
Control Solution Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142
Living With Your System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
Charging the Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
Reader Settings and Information . . . . . . . . . . . . . . . . . . . . . . . 153
App Settings and Other Menu Options . . . . . . . . . . . . . . . . .155
Maintenance and Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .163
Reader Does Not Power On . . . . . . . . . . . . . . . . . . . . . . . . . . . . .164
Problems at the Sensor Application Site . . . . . . . . . . . . . . . . 165
Problems Starting Your Sensor or Receiving
Sensor Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
Problems Receiving Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . .176
Blood Glucose Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . .182
Problems Checking Your Blood Glucose . . . . . . . . . . . . . . . . .186
Perform a Reader Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188
Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .188
System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .189
Labeling Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .196
Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . .198
Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . . . 227
Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 239
 Important Safety Information
Indications For Use
The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real
time continuous glucose monitoring (CGM) device with alarms capability
indicated for the management of diabetes in persons age 4 and older.
It is intended to replace blood glucose testing for diabetes treatment
decisions, unless otherwise indicated.
The System also detects trends and tracks patterns and aids in the
detection of episodes of hyperglycemia and hypoglycemia, facilitating
both acute and long-term therapy adjustments. Interpretation of the
System readings should be based on the glucose trends and several
sequential readings over time.
The System is also intended to autonomously communicate with digitally
connected devices. The System can be used alone or in conjunction
with these digitally connected devices where the user manually controls
actions for therapy decisions.

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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.us/support/overview.html
Use of the Sensor with devices, apps, and software that are not listed may
cause inaccurate glucose readings.
The FreeStyle Libre 3 app runs on Apple iOS and Android smart devices.
Please check www.FreeStyleLibre.com for more information about device
compatibility before upgrading your phone or its operating system.
If available, Abbott authorized Reader firmware updates will be made
accessible through www.FreeStyleLibre.com.

Contraindications
Automated Insulin Dosing: The System must not be used with
automated insulin dosing (AID) systems, including closed loop and
insulin suspend systems.

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 Contraindications (cont.)
MRI/CT/Diathermy: The System must be removed prior to
Magnetic Resonance Imaging (MRI), Computed Tomography
(CT) scan, or high-frequency electrical heat (diathermy)
treatment. The effect of MRI, CT scans, or diathermy on the
performance of the System has not been evaluated. The
exposure may damage the Sensor and may impact proper
function of the device which could cause incorrect readings.

WARNINGS:
• Do not ignore symptoms that may be due to low or high blood
glucose: If you are experiencing symptoms that are not consistent
with your glucose readings, consult your health care professional.
• Use your blood glucose meter to make diabetes treatment decisions
when you see the symbol during the first 12 hours of wearing a
Sensor, if your Sensor glucose reading does not match how you feel,
or if the reading does not include a number.
• If you are using FreeStyle Libre 3 app, you must have access to a
blood glucose monitoring system as the App does not provide one.
• Choking hazard: The System contains small parts that may be
dangerous if swallowed.

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Cautions and Limitations
The following are important cautions and limitations to keep in mind so
you can use the System safely. They are grouped into categories for easy
reference.

What to know about Reader Alarms:

• For you to receive alarms, they must be on and your Reader should
be within 33 feet of you at all times. The transmission range is 33 feet
unobstructed. If you are out of range, you may not receive glucose
alarms.
• To prevent missed alarms, make sure the Reader has sufficient charge
and that sound and/or vibration are turned on.

What to know about App Alarms:

• Disable your phone’s automatic operating system (OS) updates. Prior
to updating your phone’s OS or updating the App, you should check
the Mobile Device and OS Compatibility Guide to determine if the
FreeStyle Libre 3 app is compatible with your OS and your phone. The
OS Compatibility Guide is available in the Help Section of the App or on
www.FreeStyleLibre.com. You should check the OS Compatibility Guide
periodically to make sure that your OS and your phone continue to be
compatible with the App.

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 • In the event that an App or OS update causes your previously
compatible phone to become incompatible, you may be notified
ahead of time via e-mail or through the App. Make sure that your
LibreView account has your current e-mail address to receive important
information.
• After an OS update, open your App and check your device settings to
make sure it's working properly. Some OS features may impact your
ability to receive alarms or glucose readings. For example, if you use an
iPhone and the iOS Screen Time feature, add the FreeStyle Libre 3 app
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.
• For you to receive alarms, your phone should be within 33 feet of you at
all times. The transmission range is 33 feet 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.
• For iPhone, 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.

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• 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.
• Your phone must have a Bluetooth connection with your Sensor to
receive glucose readings and glucose alarms. In the phone settings,
keep Bluetooth ON. For iPhones, in the phone settings for the App,
allow the App to access Bluetooth.
• Check to make sure that you have the correct phone settings and
permissions enabled. If your phone is not configured properly, you will
not be able to use the App, so you will not receive alarms or be able to
check your glucose.
o iPhones: In the phone settings for the App under Notifications, keep
Allow Critical Alerts ON
o Android Phones: In the phone settings for the App, keep Do Not
Disturb Access permission ON
• If your phone is not configured correctly, the App will be in "Alarms
Unavailable" state and you will not be able to check your glucose or
receive any alarms, including the Urgent Low Glucose Alarm.

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 • To turn on Critical Alerts (iPhone) / Do Not Disturb Permission (Android
Phone), follow the instructions in the App.
• For Android Phones, 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 ringer volume (iPhone) or Media volume
(Android Phone) to silent or use the phone Do Not Disturb setting, keep
‘Override Do Not Disturb’ setting in the App ON for Low Glucose, High
Glucose, and Signal Loss Alarms to ensure you receive audible alarms.
• 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.

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 What to know before using the System:
• Review all product information before use.
• Take standard precautions for transmission of blood borne pathogens
to avoid contamination.
• Make sure that your devices and Sensor kits are kept in a safe place, and
maintain your devices under your control during use. This is important
to help prevent anyone from accessing or tampering with the System.

Who should not use the System:

• Do not use the System in people less than 4 years of age. The System
is not cleared for use in people under 4 years of age.
• Do not use the System if you are on dialysis or critically ill. The
System is not cleared for use in these groups and it is not known how
different conditions or medications common to these populations may
affect performance of the System.
• Performance of the System when used with other implanted medical
devices, such as pacemakers, has not been evaluated.

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 What should you know about wearing a Sensor:
• Wash application site on the back of your upper arm 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. Carefully preparing the site according to
these instructions will help the Sensor stay on your body for the full
wear duration specified by your Sensor insert and help prevent it from
falling off early.
• The Sensor can be worn for up to the wear duration specified by your
Sensor insert. Remember to always have your next Sensor available
before your current one ends so you can keep getting your glucose
readings.
• In the event that your Sensor stops working and you do not have
another Sensor readily available, you must use an alternate method to
measure your glucose levels and inform your treatment decisions.
• The System is designed to detect certain conditions which may occur
where the Sensor is not working as intended and shut it off, telling
you to replace your Sensor. This may occur if the Sensor gets knocked
off from the skin or if the System detects that the Sensor may not be
performing as intended. Contact Customer Service if you receive a
Replace Sensor message before the end of the wear duration specified
by your Sensor insert. Customer Service is available at 1-855-632-8658
7 Days a Week from 8AM to 8PM Eastern Time; excluding holidays.
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• 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
System. Contact your health care professional before continuing to use
the System.
• Intense exercise may cause your Sensor to loosen due to sweat or
movement of the Sensor. If the Sensor is becoming loose or if the
Sensor tip is coming out of your skin, you may get no readings or
unreliable low readings. Remove and replace your Sensor if it starts to
loosen and follow the instructions to select an appropriate application
site. Do not attempt to reinsert the Sensor. Contact Customer Service
if your Sensor becomes loose or falls off before the end of the wear
period. Customer Service is available at 1-855-632-8658 7 Days a Week
from 8AM to 8PM Eastern Time; excluding holidays.
• 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-sterilization. Further exposure to irradiation may
cause unreliable low results.
• If a Sensor breaks inside your body, call your health care professional.

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 How to Store the Sensor Kit:
• Store the Sensor Kit between 36°F and 82°F. Storage outside of this
range may cause inaccurate Sensor glucose readings.
• If you suspect that the temperature may exceed 82°F (for example, in an
un-airconditioned home in summer), you should refrigerate your Sensor
Kit. Do not freeze your Sensor Kit.
• Store your Sensor Kit in a cool, dry place. Do not store your Sensor Kit in
a parked car on a hot day.
• Store the Sensor Kit between 10-90% non-condensing humidity.

How to Store the Reader:

• Store the Reader between -4°F and 140°F. Storage in temperatures
outside of this range, such as in a parked car on a hot day, may cause the
Reader to not function properly.

When not to use the System:

• Do NOT use if the Sensor Kit package or Sensor Applicator appear to
be damaged or if tamper label indicates Sensor Applicator has already
been opened due to risk of no results and/or infection.

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• Do NOT use if Sensor Kit contents are past expiration date.
• Do NOT use if the Reader appears to be damaged due to risk of electric
shock and/or no results.

What to know about the System:

• The FreeStyle Libre 3 System 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.
• FreeStyle Libre 3 app and FreeStyle Libre 3 Readers do not share data.
Before you start a Sensor, you must choose whether to use the Reader
or the App with the Sensor. Once you start a Sensor, you cannot switch
your device.

What to know before you Apply the Sensor:

• Wash application site on the back of your upper arm 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. Carefully preparing the site according to
these instructions will help the Sensor stay on your body for the full
wear duration specified by your Sensor insert and help prevent it from
falling off early.
• Clean hands prior to Sensor handling/insertion to help prevent
infection.

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 • Change the application site for the next Sensor application to prevent
discomfort or skin irritation.
• Only apply the Sensor to the back of the upper arm. If placed in other
areas, the Sensor may not function properly.
• Select an appropriate Sensor site to help the Sensor stay attached to the
body and prevent discomfort or skin irritation. Avoid areas with scars,
moles, stretch marks, or lumps. Select an area of skin that generally
stays flat during normal daily activities (no bending or folding). Choose
a site that is at least 1 inch away from an insulin injection site.

When is Sensor Glucose different from Blood Glucose:

• Physiological differences between the interstitial fluid and capillary
blood may result in differences in glucose readings between the
System and results from a fingerstick test using a blood glucose meter.
Differences in 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.

What to know about X-Rays:

• The Sensor should be removed prior to exposing it to an X-ray machine.
The effect of X-rays on the performance of the System has not been
evaluated. The exposure may damage the Sensor and may impact
proper function of the device to detect trends and track patterns in
glucose values during the wear period.
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 When to remove the Sensor:
• If the Sensor is becoming loose or if the Sensor tip is coming out of
your skin, you may get no readings or unreliable readings, which may
not match how you feel. Check to make sure your Sensor has not come
loose. If it has come loose, remove it, apply a new one, and contact
Customer Service.
• If you believe your glucose readings are not correct or are inconsistent
with how you feel, perform a blood glucose test on your finger to
confirm your glucose. If the problem continues, remove the current
Sensor, apply a new one, and contact Customer Service. Customer
Service is available at 1-855-632-8658 7 Days a Week from 8AM to 8PM
Eastern Time; excluding holidays.

What to know about the Reader:

• Do NOT place the Reader in water or other liquids as this may cause it to
not function properly and may lead to risk of fire or burns.
• The FreeStyle Libre 3 Reader has a built-in blood glucose meter that is
designed to be used only with FreeStyle Precision Neo blood glucose
test strips and MediSense Glucose and Ketone Control Solution. Using
other test strips with the Reader’s built-in meter will produce an error
or cause the Reader’s built-in meter to not turn on or start a test. The
Reader’s built-in meter does not have ketone testing functionality.

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 • The Reader’s built-in meter is not for use on people who are
dehydrated, hypotensive, in shock, or for individuals in hyperglycemic-
hyperosmolar state, with or without ketosis.
• The Reader’s built-in meter is not for use on neonates, in critically-ill
patients, or for diagnosis or screening of diabetes.
• See Using the Reader’s Built-in Meter section for additional important
information on the use of the Reader’s built-in meter.

What to know about charging your Reader:

• Always use the Abbott provided power adapter and yellow USB cable
that came with your Reader to minimize the risk of fire or burns. Take
care when plugging and unplugging your USB cable. Do not force or
bend the end of the USB cable into the Reader's USB port.
• Choose a location for charging where you can easily access the power
adapter and quickly disconnect to prevent the potential risk of electrical
shock.
• The maximum surface temperature of the Reader and/or the power
adapter could go as warm as 111°F when it's charging or 117°F
during normal use. Under these conditions, do not hold the Reader
or the power adapter for five minutes or more. People with disorders
of peripheral circulation or sensation should use caution at this
temperature.

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• Do NOT expose the USB cable or power adapter to water or other
liquids as this may cause them to not function properly and may lead to
risk of fire or burns.

Interfering Substances
Taking ascorbic acid (vitamin C) supplements while wearing the Sensor
may falsely raise Sensor glucose readings. Taking more than 500 mg of
ascorbic acid per day may affect the Sensor readings which could cause
you to miss a severe low glucose event. Ascorbic acid can be found in
supplements including multivitamins. Some supplements, including cold
remedies such as Airborne® and Emergen-C®, may contain high doses of
1000 mg of ascorbic acid and should not be taken while using the Sensor.
See your health care professional to understand how long ascorbic acid is
active in your body.

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 Reader Symbols
Symbol What It Means
Active Sensor

Direction your glucose is going. See Understanding

Your Glucose Readings section for more information.

Caution

View previous/next screen

Sound and Vibration ON

Sound ON, Vibration OFF

Sound OFF, Vibration ON

Sound and Vibration OFF

Sensor communicating with Reader

Sensor not communicating with Reader

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Symbol What It Means
When you see this symbol during the first 12 hours
of wearing a Sensor, confirm Sensor glucose readings
with a blood glucose test before making treatment
decisions.
Notes

+ Add more information to notes

Food note
Insulin note
Time changed on Reader
Blood glucose test
Settings
Control solution test result
Low battery
Battery charging
Sensor too cold
Sensor too hot
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 App Symbols
Symbol What It Means
App icon

Alarms are unavailable

Scan New Sensor / Start New Sensor

Direction your glucose is going. See Understanding

Your Glucose Readings section for more information

Caution

When you see this symbol during the first 12 hours

of wearing a Sensor, confirm Sensor glucose readings
with a blood glucose test before making treatment
decisions

Add/edit notes

Food note
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Symbol What It Means
Insulin (Rapid or Long-acting) note

Alarm

Exercise note

Time change

Main Menu

Multiple/Custom notes

Share report (Android Phone)

Share report (iPhone)

Additional information

Calendar

Sensor too cold

Sensor too hot

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 Getting to Know Your System
The FreeStyle Libre 3 System (“System”) has two main parts: a disposable
Sensor and either a handheld Reader or mobile App to wirelessly receive
and display your glucose readings from the Sensor. Before you start
your Sensor, choose which device you want to use. The Reader and App
only work with FreeStyle Libre 3 Sensors and cannot be used with other
Sensors. When they’re in range, the Sensor and your device automatically
communicate to give you glucose alarms. These alarms are on by default.
When the Sensor and your device are not in range or unable to
communicate, the Sensor will store all 14 days of glucose data. This data
is automatically sent from the Sensor to your device when the devices are
back within range.

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 IMPORTANT:
• Before you use your System, review all the product instructions and
the Interactive Tutorial. You can access the Interactive Tutorial at
www.FreeStyleLibre.com. The Quick Reference Guide and Interactive
Tutorial give you quick access to important aspects and limitations
of the System. The User’s Manual includes all safety information and
instructions for use. Refer to your phone instructions for use for how
to use your phone.
• Go to www.FreeStyleLibre.com to view the “Tips for Kids".
• Talk to your health care professional about how you should use your
Sensor glucose information to help manage your diabetes.
• During the first 12 hours of Sensor wear the symbol will display,
and you cannot use Sensor values to make treatment decisions
during this time. Confirm Sensor glucose readings with a blood
glucose test before making treatment decisions during the first 12
hours of Sensor wear when you see the symbol.

When opening your Sensor Kit and Reader Kit, check that the contents
are undamaged and that you have all parts listed. If any parts are missing
or damaged, contact Customer Service. Customer Service is available at
1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Time; excluding
holidays. FreeStyle Libre 3 app is available for download from the App
Store (iPhone) or Google Play Store (Android Phone).

22
 Sensor Kit
The FreeStyle Libre 3 Sensor Kit includes:
• Sensor Applicator
• Product insert

Sensor Applicator
Applies the Sensor to your body.

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. The
Sensor can be worn for up to the wear duration specified by your Sensor
insert.
Note: The Sensor Applicator is sterile and
non-pyrogenic unless opened or damaged. Using
a non-sterile or pyrogenic Sensor might cause
infection.

23
Reader Kit
The Reader Kit includes:
• FreeStyle Libre 3 Reader • User’s Manual
• Yellow USB Cable • Quick Start Guides for Reader & App
• Interactive Tutorial on USB • Quick Reference Guide
• Power Adapter
Touchscreen

USB Port
Used to charge the Reader
and connect it to a computer.

Home Button
Turns the Reader on/off
and takes you to the
Test Strip Port Home Screen from any
Insert a test strip here to use other screen.
the built-in meter.

Yellow USB Cable

Power Adapter
5V, 550mA or 0.55A

24
 The Reader can be used to start a Sensor, receive glucose alarms, and get
glucose readings from the Sensor. The Reader can store approximately
90-days of glucose history and notes you enter about activities, such as
taking insulin, eating food, or exercising. This information can help you
understand how these activities affect your glucose. The Reader also
includes a built-in meter for blood glucose testing. To use the built-in
meter, you need FreeStyle Precision Neo blood glucose test strips, control
solution, a lancing device, and lancets. These items are not included in
the Reader Kit and must be obtained separately from your FreeStyle
Libre 3 System provider (pharmacy or mail order supplier). If you suspect
an adverse cybersecurity event related to the FreeStyle Libre 3 System,
contact Customer Service.

IMPORTANT:
• If the Reader is dropped or subjected to impact, do a Reader
Test to check that it is still working properly. See Perform a
Reader Test section for instructions.
• If the Reader becomes too hot to hold, do NOT use and contact
Customer Service about replacing your Reader, yellow USB
cable, and power adapter. Customer Service is available at
1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Time;
excluding holidays.

25
FreeStyle Libre 3 app
You can use the App to start a Sensor, receive glucose alarms, get
glucose readings from the Sensor, and store your glucose history and
notes you enter.

FreeStyle Libre 3 iOS app is available for download

from the App Store.
FreeStyle Libre 3 Android app is available for download
from Google Play Store.

The App is not compatible with all phones. Before upgrading your phone
or its operating system, check www.FreeStyleLibre.com.
• You must keep Critical Alerts (iPhone) / Do Not Disturb Permission
(Android Phone) and Bluetooth on. If these settings are turned off, you
will not be able to use the App, so you will not receive alarms or be
able to check your glucose.
• You are responsible for properly securing and managing your phone.
If you suspect an adverse cybersecurity event related to the FreeStyle
Libre 3 System, contact Customer Service.
• FreeStyle Libre 3 is not intended for use on a phone that has
been altered or customized to remove, replace or circumvent the
manufacturer’s approved configuration or use restriction, or that
otherwise violates the manufacturer’s warranty.
26
 Reader Home Screen
The Reader Home Screen provides access to information about your
glucose and the System. You can press the Home Button to get to the
Home Screen.

Current time set on Battery charge remaining

the Reader
Sound/Vibration setting
Sensor Status
Signal Status
Information about your
current Sensor. Shows if Sensor is
communicating with
View Glucose
10:23pm Reader.
Ends in 14 days
Touch to view your
Sensor glucose. Settings
View Glucose
Touch to access Alarms,
Review History Reminders, and other
Review History Reader settings.
Touch to review information
about your past glucose
readings. Start New Sensor

Start New Sensor

Touch to start a new
Sensor.

27
App Home Screen
The App Home Screen displays your current glucose, glucose trend
arrow, and glucose graph. It is automatically updated every minute with
glucose data from the Sensor.
Main Menu
Tap to access the Home screen, Message
Alarms, Logbook, other history You may be able to tap the message
options, and Connected Apps. for more information.
You can also access Settings,
Help, and other information.
Glucose Trend Arrow
Direction your glucose is going.
Alarms Unavailable    


The symbol displays if
alarms are not available.
Tap the symbol for more
 
Note Symbol
Tap to review notes you've entered.
information. 



Current Glucose  High Glucose Alarm Level

Your most recent glucose value.  Your High Glucose Alarm level.
Glucose Graph 

Graph of your current and 

Target Glucose Range
stored glucose readings. The graph shows your target

glucose range. This is not related
 to glucose alarm levels.
Add Note
Tap to add notes to the    

glucose reading. 

Sensor Life       Low Glucose Alarm Level

Remaining life time of Sensor. Your Low Glucose Alarm level.
(Example screen displayed for iPhone)

28
 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 download and install 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.

29
 Setting up Your System for the First Time
Reader Setup
Complete the setup if you want to use the Reader with the Sensor or use
the Reader’s built-in meter.
Step Action

1 Press the Home Button to turn on the Reader.

2 If prompted, use the touchscreen to select your

preferred language for the Reader. Touch OK to
continue.
Note: Use the pad of your finger. Do NOT use
your fingernail or any other object on the screen.

30
 Step Action

3 Current Date Set the Current Date using the arrows on the
touchscreen. Touch next to continue.
14 June
2022

back next

4 Current Time Set the Current Time. Touch next to continue.

CAUTION: It is very important to set the time

12 am 00
and date correctly. These values affect the
Reader data and settings.
back next

31
Step Action

5 The Reader now displays important information about key

topics to help you use the System. Touch next after reviewing
each screen. Touch done to go to the Home Screen.

32
 App Setup
Complete the setup if you want to use the App with the Sensor.
Note: 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.
Step Action

1 Check that your phone is connected to a network (WiFi or

cellular). You can then install FreeStyle Libre 3 app from the App
Store (iPhone) or Google Play Store (Android Phone). 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 authorized apps
through the Connected Apps menu option within the FreeStyle
Libre 3 app. You do not need to be connected to get glucose
data from a Sensor, add notes, or review your history in the App.

2 S wipe left to view some helpful tips or tap GET STARTED NOW
at any point.

33
Step Action

3 Confirm phone and OS compatibility and tap NEXT.

4 Confirm your country and tap NEXT.

5 You may need a LibreView account to use the App. Follow

onscreen instructions to review legal information, phone
warnings, and create a new account or login to your existing
account. You can continue using an existing Sensor with the
App on a compatible phone that is logged into the same
LibreView account.

34
 Step Action

6 Confirm your glucose unit of measure and tap NEXT.

7 Select how you count carbohydrates (in grams or servings) and

tap NEXT. The carbohydrate unit will be used in any food notes
you enter in the App.

8 The App now displays some important information. Accept the

requested permissions.
Tap NEXT after reviewing each screen.

9 Apply a new Sensor and then tap NEXT. Go to Starting Your

Sensor section.
Note: If you need help applying your Sensor, tap HOW TO
APPLY A SENSOR or go to Applying Your Sensor section.

35
Applying Your Sensor

CAUTION: Intense exercise may cause your Sensor to loosen

due to sweat or movement of the Sensor. If the Sensor is
becoming loose or if the Sensor tip is coming out of your skin,
you may get no readings or unreliable low readings. Remove
and replace your Sensor if it starts to loosen and follow the
instructions to select an appropriate application site. Do not
attempt to reinsert the Sensor. Contact Customer Service if
your Sensor becomes loose or falls off before the end of the
wear period. Customer Service is available at 1-855-632-8658
7 Days a Week from 8AM to 8PM Eastern Time; excluding
holidays.

IMPORTANT: Before using your Sensor Applicator, make sure you

have an alcohol wipe (70% isopropyl alcohol) on hand to prepare
the application site. This is not included in the Sensor Kit.

36
 Step Action

1  pply Sensors only on the back of your upper

A
arm. If placed in other areas, the Sensor may not
function properly and could give you inaccurate
readings. 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 1 inch
(2.5 cm) away from an insulin injection site. To
prevent discomfort or skin irritation, you should
select a different site other than the one most
recently used.

2  ash application site using a plain soap, dry, and

W
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 following
these instructions, or the Sensor may not stay
on for the full wear duration specified by your
Sensor insert.

37
Step Action

3  nscrew the cap from the Sensor Applicator and

U
set the cap aside.

CAUTION:
• Do NOT use if the Sensor Kit package or
Cap

Tamper

Sensor Applicator appear to be damaged

Label

or 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.

38
 Step Action

4  lace the Sensor Applicator over the prepared

P
site and push down firmly to apply the Sensor to
your body.

CAUTION: Do NOT push down on the Sensor

Applicator until placed over prepared site to
prevent unintended results or injury.

5  ently pull the Sensor Applicator away from your

G
Sensor 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 contact your
health care professional.

39
Step Action

6  ake sure the Sensor is secure after application.

M
Put the cap back on the Sensor Applicator.
Discard the used Sensor Applicator according to
local regulations.
Note: If using the App, you can tap Help in
the Main Menu to access an in-app tutorial on
applying a Sensor.

40
 Starting Your Sensor
Starting Your Sensor with the Reader
Before you start your Sensor, choose which device you want to use. If you
start the Sensor with the Reader, you will be unable to use the App to
check your glucose or receive alarms.
Step Action

1 Press the Home Button to turn on the Reader.

2 10:23pm
No Active Sensor Touch Start New Sensor.
View Glucose

Review History

Start New Sensor

41
Step Action

3  old the Reader near the Sensor to scan it. This

H
starts your Sensor. If sounds are turned on,
the Reader beeps when the Sensor has been
successfully activated. The Sensor can be used to
New Sensor
Starting Up
OK
check your glucose after 60 minutes.
Note: If the Sensor is not successfully scanned
Sensor can be used in:

60
minutes
within 15 seconds, the Reader displays a prompt
to scan the Sensor again. Touch OK to return to
the Home Screen and touch Start New Sensor
to scan your Sensor.

42
 Starting Your Sensor with the App
Before you start your Sensor, choose which device you want to use. If you
start the Sensor with the App, you will be unable to use the Reader to
check your glucose or receive alarms.

IMPORTANT:
• The App requires that your phone has date and time enabled
to set automatically. You can check this in your phone settings.
Manual changes to your phone’s time and date setting can lead to
incorrect time stamp or inability to use the App.
• When using the App, you should keep your phone well charged
and be sure you have access to a blood glucose monitoring
system.
• When you start your Sensor, you will receive a tone and vibration.
If your phone's volume is turned off, you will not hear the tone.

43
• iPhone Users: The NFC (Near Field Communication) antenna is
on the top edge of iPhone. Hold this area near your Sensor when
you are scanning. You may need to adjust your scan distance
based on what clothing you are wearing. In addition to proximity
and orientation, other factors can affect 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 may vary
between phone models.
• Android Phone Users: The NFC (Near Field Communication)
antenna is located on the back side of most Android Phones.
Move your phone around slowly and, if needed, gently touch the
Sensor. In addition to proximity and orientation, other factors can
affect 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 may vary between phone models.
• Please check www.FreeStyleLibre.com for more information
about device compatibility and the location of the NFC antenna
on your phone.

44
 iPhone Users
Step Action

1 From the App Home Screen, tap the Scan New Sensor
button. Your phone is now ready to scan the Sensor to start
it.

2 Touch the Sensor with the TOP of your phone. You will
receive a tone and vibration after you have successfully
started the Sensor. If your phone’s volume is turned off,
you will not hear the tone.

45
 Step Action

3 The Sensor can be used to check your glucose after

60 minutes. While the Sensor is starting up, you can
navigate away from the App. If notifications are enabled,
you will see a notification when the Sensor is ready.
Note: If you have an active Sensor and want to start a new
Sensor, go to the Menu and tap Start New Sensor .

Android Phone Users

Step Action

1 From the App Home Screen, scan the Sensor with the BACK
of your phone to start it. You will receive a tone and vibration
after you have successfully started the Sensor. If your
phone’s volume is turned off, you will not hear the tone.
Note: Each phone model is different. Touch the Sensor with
your phone or move your phone around slowly until you
learn how to scan.

46
 Step Action

2 The Sensor can be used to check your glucose after

60 minutes. While the Sensor is starting up, you can
navigate away from the App. You will see a notification when
the Sensor is ready.
Note: If you have an active Sensor and want to start a new
Sensor, go to the Menu and tap Start New Sensor .

Note:
• If you need help, tap HOW TO SCAN A SENSOR to view an in-app
tutorial. You can also access this later by going to the Main Menu and
then tapping Help.
• If your Sensor is not successfully scanned, you may receive a Scan Error
message. Follow the instructions in the message.
• See Troubleshooting section for additional error messages.

47
Checking Your Glucose
Checking Your Glucose with the Reader
Step Action

1 10:23pm
T urn the Reader on by pressing
the Home Button or touch
Ends in 14 days

OR View Glucose

View Glucose from the Home

Review History

Start New Sensor Screen.

The Reader displays your current glucose reading. It includes

2 your Current Glucose, a Glucose Trend Arrow indicating which
way your glucose is going, and a graph of your current and
stored glucose readings.

48
 Step Action

2 Add Notes
(cont.) Touch to add notes to
Message
the glucose reading.
Touch for more
information.
Glucose Trend
Glucose Going
Low Arrow

82
Current Glucose Direction your
Your most recent glucose is going.
glucose value. mg
dL
Food Note Insulin Note
350

250 High Glucose Alarm Level

150
Target Glucose Range Glucose Graph
Your Target Glucose 50 Graph of your current
Range is not related to 10am 4pm 10pm and stored glucose
your glucose alarm readings.
settings.
Low Glucose Alarm Level

Note:
• The graph displays glucose readings above 350 mg/dL as
350 mg/dL. For sequential readings above 350 mg/dL, a line
is displayed at 350 mg/dL. The Current Glucose number can
be as high as 400 mg/dL.

49
Step Action

2 • The symbol may appear, indicating the Reader time was

(cont.) changed. Gaps in the graph may result or glucose readings
may be hidden.
• All available glucose data is used to make your graph so you
can expect to see some differences between the graph line
and previous current glucose readings.
• Results screen will not automatically update even if new
data has arrived. Return to the Home Screen by pressing the
Home Button and then touch View Glucose to update the
results screen.

Checking Your Glucose with the App

Step Action

1 Open the App.

50
 Step Action

2 If you have an active Sensor, the Home Screen displays your

glucose reading. It includes your Current Glucose, a Glucose
Trend Arrow indicating which way your glucose is going, and a
graph of your current and stored glucose readings.



Current Glucose
 
Glucose Trend Arrow









Glucose Graph 







   



   

(Example screen displayed for iPhone)

51
Step Action

2 Current Glucose - Your most recent glucose value.

(cont.) Glucose Trend Arrow - Direction your glucose is going.
Glucose Graph - Graph of your current and stored glucose
readings.

Note:
• The graph displays glucose readings above 350 mg/dL as
350 mg/dL. For consecutive readings above 350 mg/dL, a
line is displayed at 350 mg/dL. The Current Glucose number
can be as high as 400 mg/dL.
• The symbol may appear, indicating the phone’s time was
changed.
• All available glucose data is used to make your graph so you
can expect to see some differences between the graph line
and previous current glucose readings.

52
 • Your current glucose value determines the background color on the
Home Screen:
Orange - High glucose (above 250 mg/dL)

Yellow - Between the Target Glucose Range and high or low glucose level

Green - Within the Target Glucose Range

Red - Low glucose (below 70 mg/dL)

• If you are not receiving glucose readings you will not receive Low
or High Glucose Alarms.
• In order for the FreeStyle Libre 3 app to share data with other
connected apps, please do the following:
o Enable WiFi or cellular service.
o Disable Low Data mode.

53
Understanding Your Glucose Readings
Glucose Trend Arrow
The Glucose Trend Arrow gives you an indication of the direction your
glucose is going.

Glucose is rising quickly

(more than 2 mg/dL per minute)

Glucose is rising
(between 1 and 2 mg/dL per minute)

Glucose is changing slowly

(less than 1 mg/dL per minute)

Glucose is falling
(between 1 and 2 mg/dL per minute)

Glucose is falling quickly

(more than 2 mg/dL per minute)

54
 Messages
Below are messages you may see with your glucose readings.
Reader App
What To Do
Display Display

If LO appears, your reading is lower

Low Glucose

than 40 mg/dL. If HI appears, your

LO mg 

reading is higher than 400 mg/dL.


dL
350

250 You can tap the symbol for

more information. Check your
150 High Glucose

HI
50

blood glucose on your finger with

10am 4pm 10pm
mg
dL
350

250
a test strip. If you get a second LO
150

50
or HI result after doing a blood
10am 4pm 10pm
glucose test, contact your health
care professional immediately.

Note: In the App, the background

color corresponds to your current
glucose value.

55
 Reader App
What To Do
Display Display

If your glucose is higher than

Low Glucose

250 mg/dL or lower than

63


70 mg/dL, you will see a message

mg 


dL
350

250 High Glucose


on the screen. You can tap the
symbol for more information
289
150

50

and set a reminder to check your

10am 4pm 10pm
mg
dL

glucose.
350

250

150

50
10am 4pm 10pm

Glucose Going

If your glucose is projected to

Low

be higher than 250 mg/dL or

72


lower than 70 mg/dL within


mg


dL
350

250
Glucose Going
High

15 minutes, you will see a
237 message on the screen. You can
150

50
mg

tap the symbol for more

10am 4pm 10pm dL
350

information and set a reminder

250

150

50
10am 4pm 10pm to check your glucose.

56
 Reader App
What To Do
Display Display
7:03am
Ends in 14 days

During the first 12 hours of Sensor

110 mg
 
wear the symbol will display,
dL
and you cannot use Sensor values
350

250 to make treatment decisions

150

50
during this time. Confirm Sensor
6pm 12am 6am
glucose readings with a blood
glucose test before making
treatment decisions during the
first 12 hours of Sensor wear when
you see the symbol.

Note:
• If you are not sure about a message or reading, contact your health care
professional before you do anything.
• Messages you receive with your glucose readings are not related to
your glucose alarm settings.
57
 Making Treatment Decisions
Work with your health care professional to put together a plan for
managing your diabetes that includes when to use the System information
for making treatment decisions. You should also talk to your health
care professional about the best times to check your glucose. Consider
checking your glucose before a period when you will not be monitoring
your glucose, such as before driving, exercising or sleeping.
WARNING: The System can replace blood glucose testing except in
the below situations. These are the times when you need to do a blood
glucose test before deciding what to do or what treatment decision to
make as Sensor readings may not accurately reflect blood glucose levels:
Do a blood glucose test if you think your
glucose readings are not correct or do not
match how you feel. Do not ignore symptoms
that may be due to low or high glucose.
Do a blood glucose test when you see the
symbol during the first 12 hours of wearing a
Sensor or the Sensor glucose reading does not
include a Current Glucose number.

58
 Making Treatment Decisions – Getting Started
Before you start using the System for treatment decisions, make sure
you have a good understanding of how the System works for your body.
Continue to use your blood glucose meter for treatment decisions
until you are comfortable with the information you receive from your
System. This includes understanding that: Sensor performance can vary
in between Sensors, within a Sensor wear period (duration specified by
your Sensor insert), and in different situations. There may be variations
between Sensors during the first 12 hours after insertion, so pay attention
to how each newly inserted Sensor is working for you when deciding
whether to make treatment decisions based on your Sensor readings.
Getting familiar with the System could take days, weeks, or even months.
The more you check readings from the System with a blood glucose
meter, the better you will understand how the System works for you.
Work with your health care professional to put together a plan for
managing your diabetes that includes when to use the System
information for making treatment decisions.

59
Helpful Tips
• Confirm your Sensor glucose readings with a blood glucose meter until
you understand:
o Sensor accuracy may vary between Sensors.
o Sensor accuracy may vary during a Sensor wear session.
o Sensor accuracy may vary in different situations (meals, exercise, first day of
use, etc.).
•  heck your glucose often to see how carbs, medication, exercise, illness,
C
or stress levels impact your Sensor glucose readings. The information
you get can help you figure out why your glucose sometimes goes too
high or too low, and how to prevent it from doing so in the future.
• T alk to your health care professional about how your insulin works. The
more you understand about your insulin, including how long it takes to
start working and how long it lasts in your body, the more likely you will
be to make better treatment decisions.
•  aking a treatment decision doesn’t just mean taking insulin. Treatment
M
decisions can also include things like taking fast-acting carbs, eating, or
even doing nothing and checking again later.

60
 •  our health care professional can also help you to understand when
Y
doing nothing and checking again later is the right treatment decision.
For example, if your glucose is high and going up, your first instinct may
be to take more insulin to lower your glucose, however depending on
when you last took insulin or your recent activity, the right treatment
decision may be to do nothing and check again later. Avoid “insulin
stacking”.
• Sensor glucose values, which are based on interstitial fluid glucose
levels, can be different from blood glucose levels (fingersticks),
particularly during times when your blood glucose is changing quickly.
If your glucose readings and alarms from the System do not match your
symptoms or expectations, use a fingerstick blood glucose value from a
blood glucose meter to make diabetes treatment decisions.

61
 Glucose
Sensor Glucose Rising
80 mg/dL Quickly
Blood Glucose
100 mg/dL
Blood Glucose
70 mg/dL
Glucose Sensor Glucose
Falling 95 mg/dL
Quickly

When not to use Sensor Glucose readings for treatment decisions

No Current Glucose Number

When there is no Current Glucose number, such as when you receive an
error message or a LO or HI result, you don’t have enough information to
make a treatment decision. Do a blood glucose test and treat based on
that result.

62
 When you see the symbol during the first 12 hours of wearing a
Sensor
During the first 12 hours of Sensor wear the symbol will display, and
you cannot use Sensor values to make treatment decisions during this
time. Confirm Sensor glucose readings with a blood glucose test before
making treatment decisions during the first 12 hours of Sensor wear when
you see the symbol.

Think Your Readings are Incorrect?

Don’t trust Sensor glucose readings that you think may be incorrect or
that don’t match what you would expect based on your recent activity.
For example, if you ate dinner but forgot to take insulin before eating, you
would expect your glucose to be high. If your glucose reading is low, then
it doesn’t match your recent activity, so don’t use it to make treatment
decisions. Don’t make treatment decisions if you think your Sensor
glucose readings are incorrect. Do a blood glucose test and treat based on
that result.

63
Symptoms Don’t Match Readings
There may be times when your symptoms don’t match your Sensor
glucose readings. For example, you are feeling shaky, sweaty, and dizzy
– symptoms you generally get when you have low glucose, but your
glucose reading is within your target range. When symptoms don’t match
readings, do a blood glucose test and treat based on that result. Don’t
ignore symptoms that may be due to low or high blood glucose.
If you’re the caregiver, pay attention to times when the symptoms of the
one you’re caring for don’t match their Sensor glucose readings. When
symptoms don’t match readings, do a blood glucose test and treat based
on that result.
When to do Nothing and Check Again Later
Your health care professional can help you understand when doing
nothing and checking again later is the right treatment decision. For
example, if your glucose is high and going up, your first instinct may be to
take more insulin to lower your glucose, however depending on when you
last took insulin or your recent activity, the right treatment decision may
be to do nothing and check again later.
Don’t take a correction dose within 2 hours of your meal dose. This may
result in “insulin stacking” and low glucose.

64
 Using Your Glucose Reading to Make a Treatment
Decision
 fter you check your glucose, use all of the information on the
A
screen when deciding what to do or what treatment decision
to make.
Reader
Glucose Trend Arrow
Direction your glucose is going
Current Glucose
Arrow What it means
Message Glucose rising quickly

Glucose Going Glucose rising

Low

82
Glucose changing slowly
Glucose
Trend Glucose falling
mg
dL Arrow Glucose falling quickly

350

250 Glucose Graph

Graph of your current and stored glucose readings
150 Food Note Insulin Note

50 mg/dL 350
10am 4pm 10pm
250

150
Target
Glucose Graph Glucose
Current
50 Glucose
Range 10am 4pm 10pm

Time

65
 App
Glucose Trend Arrow
Current Glucose Direction your glucose is going

Arrow What it means

Message
Glucose rising quickly

Glucose rising

 
Glucose
Trend
Arrow
Glucose changing slowly

 Glucose falling

Glucose falling quickly

Glucose Graph
Graph of your current and stored glucose readings



Food Note Insulin Note

Glucose Graph Target

Glucose
Range Current
Glucose

Time

66
 This table provides some information on how you can factor the Glucose
Trend Arrow into your treatment decisions. Remember that you should
never make a treatment decision based on the Glucose Trend Arrow
alone.
Treatment Decision Considerations
Glucose
Trend
Low Glucose Glucose in High Glucose
Arrow
(< 70 mg/dL) Target Range (> 250 mg/dL)

Treat low glucose If you are about to eat, If you are about to eat,
according to your health take insulin to cover take insulin to cover
care professional’s your meal. Consider your meal. Consider
recommendation. taking a little more since taking a little more since
glucose is rising quickly. glucose is high and
If you have taken insulin rising quickly.
recently, do nothing and If this is between
check again later. meals, consider taking
Avoid “insulin stacking”. an insulin correction
dose, unless you have
taken insulin recently. If
you have taken insulin
recently, do nothing and
check again later.
Avoid “insulin stacking”.

67
 Treatment Decision Considerations
Glucose
Trend
Low Glucose Glucose in High Glucose
Arrow
(< 70 mg/dL) Target Range (> 250 mg/dL)

Treat low glucose If you are about to eat, If you are about to eat,
according to your health take insulin to cover take insulin to cover
care professional’s your meal. Consider your meal. Consider
recommendation. taking a little more since taking a little more since
glucose is rising. glucose is high and
If you have taken insulin rising.
recently, do nothing and If this is between
check again later. meals, consider taking
Avoid “insulin stacking”. an insulin correction
dose, unless you have
taken insulin recently. If
you have taken insulin
recently, do nothing and
check again later.
Avoid “insulin stacking”.

68
 Treatment Decision Considerations
Glucose
Trend
Low Glucose Glucose in High Glucose
Arrow
(< 70 mg/dL) Target Range (> 250 mg/dL)

Treat low glucose If you are about to eat, If you are about to eat,
according to your health take insulin to cover take insulin to cover
care professional’s your meal. your meal. Consider
recommendation. If this is between meals, taking a little more since
do nothing and check glucose is high.
again later. If this is between
meals, consider taking
an insulin correction
dose, unless you have
taken insulin recently. If
you have taken insulin
recently, do nothing and
check again later.
Avoid “insulin stacking”.

69
 Treatment Decision Considerations
Glucose
Trend
Low Glucose Glucose in High Glucose
Arrow
(< 70 mg/dL) Target Range (> 250 mg/dL)

Treat low glucose If you are about to eat, If you are about to eat,
according to your health take insulin to cover take insulin to cover
care professional’s your meal. Consider your meal. Consider
recommendation. taking a little less since taking a little less since
glucose is falling. glucose is falling.
If this is between If this is between meals,
meals, consider eating consider doing nothing
a snack or fast-acting and check again later.
carbohydrates to stay Avoid “insulin stacking”.
within target and check
again later.

70
 Treatment Decision Considerations
Glucose
Trend
Low Glucose Glucose in High Glucose
Arrow
(< 70 mg/dL) Target Range (> 250 mg/dL)

Treat low glucose If you are about to eat, If you are about to eat,
according to your health take insulin to cover take insulin to cover
care professional’s your meal. Consider your meal. Consider
recommendation. taking a little less taking a little less
since glucose is falling since glucose is falling
quickly. quickly.
If this is between If this is between meals,
meals, consider eating consider doing nothing
a snack or fast-acting and check again later.
carbohydrates to stay Avoid “insulin stacking”.
within target and check
again later.

71
Example Scenarios
Here are some example scenarios to help you understand how to use the
information on your screen. Always use all of the information on the screen
before deciding what to do or what treatment decision to make. If you are
not sure about what to do, consult your health care professional.
What you see What it means
When you wake-up: When you wake-up on your first day
of wearing a Sensor, your current
Reader glucose is 110 mg/dL. There is also the
App
7:03am
Ends in 14 days symbol on the screen.
110


mg
dL
 
During the first 12 hours of Sensor
350

250

wear the symbol will display, and


150
 you cannot use Sensor values to make
treatment decisions during this time.
50

6pm 12am 6am


 Confirm Sensor glucose readings with




a blood glucose test before making






 
treatment decisions during the first


 
12 hours of Sensor wear when you see
the symbol.

72
 What you see What it means
Before breakfast: Before breakfast, your current glucose
is 115 mg/dL. The graph shows that
Reader
your glucose is going up and so does
8:06am
Ends in 2 days
App the trend arrow .
115
350
mg
dL


 
Consider what might be causing your
250

glucose to go up and what you might
150

do to prevent a high glucose. For



50 

example:
8pm 2am 8am




 • How much insulin should you take


before your meal?








  • Since you see , should you


consider taking a little more insulin?
 

73
 What you see What it means
Before lunch: When you checked your glucose before
lunch, it was 90 mg/dL and rising.
Reader
Before eating lunch, you took enough
12:00pm
Ends in 3 days App insulin to cover the meal and a little

350
90 mg
dL


 
more since your trend arrow was .

250


150

50 

12am 6am 12pm











    



  

74
 What you see What it means
After lunch: 90 minutes later, your current glucose
is 225 mg/dL. The graph shows that your
Reader
glucose is still going up, and so does the
1:30pm
Ends in 3 days
App trend arrow .
225
350
mg
dL

 
Don’t take a correction dose within
2 hours of your meal dose. This may
250

result in “insulin stacking” and low



150 

50

glucose.

1am 7am 1pm





Consider what might be causing your
glucose to go up and what you might




   

do to prevent a high glucose. For

example:


• Has the insulin you took for your meal

reached its full effect?
• Check your glucose again later.

75
 What you see What it means
In the afternoon: Between meals, your current glucose is
72 mg/dL. The Glucose Going Low
Reader
message tells you that your glucose is
projected to be low within 15 minutes.
Glucose Going
Low
App

72 mg
dL



Think about what might be causing
your glucose to go low. Consider eating
350 

250

a snack to stay within target. Avoid



150 

50 
3am 9am 3pm
 taking insulin as this can cause low

glucose.






   



  

76
 What you see What it means
After exercising: After exercising, you are feeling shaky,
sweaty, and dizzy – symptoms you
Reader
5:47pm
generally get when you have low
Ends in 9 days
App glucose. But, your current glucose is
204
350
mg
dL

 
204 mg/dL.
Anytime you get a reading that doesn’t
250

match how you feel, do a blood



150 

50

glucose test.


5am 11am 5pm











   





77
 What you see What it means
Before dinner: Before dinner, your current glucose is
134 mg/dL. The graph shows that your
Reader glucose is going down and so does
7:34pm
Ends in 7 days
App the trend arrow .
134
350
mg
dL


 
Consider what might be causing your
glucose to go down and what you
250

150

 might do to prevent a low glucose. For
50
7am 1pm 7pm



example:

• How much insulin should you take
to cover your meal?





• Since you see , should you think
about taking a little less insulin?
   



 

78
 Other considerations
Deciding how much rapid-acting insulin to take for different meals and
situations can be difficult. Work with your health care professional to
discuss different situations and what might work best for you. Here are
some questions to consider:
Meal dosing
• What do you do if your before meal glucose is high?
• What do you do if your before meal glucose is low?
• How much time do you wait to eat after taking your meal insulin?
• Do you adjust the amount of meal insulin based on the number of carbs
or how much you are planning to eat?
• Do you adjust your meal insulin dose for high fat foods such as pizza?
• Do you know how to adjust your insulin doses when drinking alcoholic
beverages?
High glucose corrections
• Do you take extra insulin if your glucose is high?
• How do you decide how much insulin to take for a high glucose?
• How long do you wait between insulin doses to avoid insulin stacking?

79
Bedtime
• How often do you check your glucose before bed?
• What do you consider a safe bedtime glucose?
• What do you do if your bedtime glucose is high?
• What do you do if your bedtime glucose is low?
• When should you eat a bedtime snack?
• What do you do if your before meal glucose is high?
• What do you do if your before meal glucose is low?
Other factors
• How do you adjust your insulin dose based on the Glucose Trend Arrow?
• How do you adjust your insulin dose for different types of exercise or
activities?
• How do you adjust your insulin doses for stress?
• How do you adjust your insulin doses for illness?

80
 Reader Alarms
When in range of the Reader, your Sensor automatically communicates
with the Reader to give you Low and High Glucose Alarms. These alarms
are on by default.
Please read all the information in this section before setting and using
alarms.

IMPORTANT: Glucose alarms are an important safety feature for

some people. For example, those that have impaired awareness of
hypoglycemia or a history of severe hypoglycemia. Before you turn
alarms off or change their settings, please consult your health care
professional.

CAUTION:
• For you to receive alarms, they must be on and your Reader should
be within 33 feet of you at all times. The transmission range is 33
feet unobstructed. If you are out of range, you may not receive
glucose alarms.
• To prevent missed alarms, make sure the Reader has sufficient
charge and that sound and/or vibration are turned on.

81
IMPORTANT: What to know about glucose alarms
• Check your glucose often. If you get a Low or High Glucose
Alarm, you must obtain a glucose result to determine what to
do next.
• The Low and High Glucose Alarms should not be used
exclusively to detect low or high glucose conditions. The
glucose alarms should always be used along with your current
glucose, glucose trend arrow, and glucose graph.
• Low and High Glucose Alarm levels are different from your
Target Glucose Range values. Low and High Glucose Alarms
tell you when your glucose has passed the level you set in
the alarm. Your Target Glucose Range is displayed on glucose
graphs on the Reader and used to calculate your Time In
Target.

82
 IMPORTANT: How to prevent missed alarms
• Alarms must be kept on for you to receive them and you should
ensure that your Reader is within 33 feet of you at all times. The
Sensor itself will not issue alarms.
• If the Sensor is not communicating with the Reader,
you will not receive glucose alarms, and you may miss
detecting low glucose or high glucose episodes. You will
see the symbol on the Home Screen when the Sensor is
not communicating with the Reader. Make sure the Signal
Loss Alarm is on so you will be notified if your Sensor has not
communicated with the Reader for 20 minutes.
• Make sure the Reader’s sound and/or vibration settings are on
and your Reader is near you. The Home Screen indicates the
sound/vibration setting when any alarm is on:
Sound and Vibration ON
Sound ON, Vibration OFF
Sound OFF, Vibration ON
Sound and Vibration OFF

83
Setting Reader Alarms
Work with your health care professional to determine your alarm settings.
Step Action

1 F rom the Home Screen, touch the Settings

10:23pm
Ends in 14 days

View Glucose
symbol . Touch Alarms.
Review History

Settings
Start New Sensor

Alarms

Sound & Vibration

Time & Date

1/4

2 Alarm Settings OK
Touch Change Alarm Settings.
Low Glucose 70 mg/dL

High Glucose 250 mg/dL

Signal Loss On

Change Alarm Settings

84
 Step Action

3 Change Alarm
Settings
OK
Select the alarm you want to set or turn off.
Low Glucose Alarm

High Glucose Alarm

CAUTION: If alarms are turned off, you will
Signal Loss Alarm not get a notification when you have low
glucose or high glucose.

Low Glucose Alarm: Notifies you when your

glucose is below the level you set.
High Glucose Alarm: Notifies you when your
glucose is above the level you set.
Signal Loss Alarm: Notifies you when your
Sensor is not communicating with the Reader
and that you will not receive Low or High
Glucose Alarms.

85
Alarm How to Set
Low The Low Glucose Alarm is on by default.
Glucose The alarm level is initially set to Low Glucose Alarm ?
Alarm 70 mg/dL. You can use the arrows
to change this value between 70
60 mg/dL and 100 mg/dL. If the mg/dL

alarm is on, you will be notified On

when your glucose falls below the done

level you set. Touch the slider to

turn the alarm off.
Touch done to save.

86
 Alarm How to Set
High The High Glucose Alarm is on by default.
Glucose The alarm level is initially set to High Glucose Alarm ?
Alarm 250 mg/dL. You can use the arrows
to change this value between 250
120 mg/dL and 400 mg/dL. If the mg/dL

alarm is on, you will be notified On

when your glucose rises above the done

level you set. Touch the slider to

turn the alarm off.
Touch done to save.

Signal If the alarm is on, you will be Signal Loss Alarm

Loss notified when your Sensor has not On

Alarm communicated with your Reader Turn On to get notified when

the glucose alarms you set are

for 20 minutes and you are not not available because your
Sensor is not communicating
with the Reader.

receiving Low or High Glucose

Alarms. Touch the slider to turn the done

alarm off.
Touch done to save.

87
Step Action

4 Change Alarm OK When you are finished setting your alarms,

Settings
touch OK. The Alarms Settings screen now
Low Glucose Alarm
shows your current alarm settings. Touch OK
High Glucose Alarm
to return to the main Settings menu, or touch
Signal Loss Alarm
Change Alarm Settings to make additional
Alarm Settings OK
updates.
Low Glucose 70 mg/dL

High Glucose 250 mg/dL

Signal Loss On

Change Alarm Settings

88
 Setting Reader Alarm Sounds
Step Action

1 10:23pm
Ends in 14 days
F rom the Home Screen, touch the
Settings symbol . Touch Sound &
Vibration to change the alarm sounds.
View Glucose

Review History
Settings
Start New Sensor

Alarms

Sound & Vibration

Time & Date

1/4

2 Sound & Vibration OK

Touch the sound or vibration setting you
would like to change.
System
On
Sounds

High
Note: These settings apply to the alarms
Volume
as well as other Reader functions.
Vibration Off

Touch
Sounds
Off
Touch OK to save.

89
Using Reader Alarms
What you See What it Means

Low Glucose Alarm

The Low Glucose Alarm notifies you if your
glucose drops below the level you set.
63 mg
dL Touch Dismiss Alarm or press the Home Button
Dismiss Alarm
to dismiss the alarm. You will only receive one
alarm per low glucose episode.

High Glucose Alarm

The High Glucose Alarm notifies you if your
glucose rises above the level you set.
252 mg
dL Touch Dismiss Alarm or press the Home Button
Dismiss Alarm
to dismiss the alarm. You will only receive one
alarm per high glucose episode.

90
 What you See What it Means

Signal Loss Alarm

The Signal Loss Alarm notifies you if your Sensor
has not communicated with the Reader for 20
minutes and you are not receiving Low or High
Glucose Alarms. Signal loss could be caused by
the Sensor being too far away from the Reader
Dismiss Alarm

(over 33 feet) or another issue such as an error or

problem with your Sensor or Reader.
Touch Dismiss Alarm or press the Home Button
to dismiss the alarm. You will only receive one
alarm per signal loss episode.

Note: If you ignore an alarm, you will receive it again in 5 minutes

if the condition still exists.

91
 App Alarms
FreeStyle Libre 3 app includes several types of alarms. These are all turned
on by default and initially set to sound regardless of your phone's sound
or Do Not Disturb settings. If there's a time where you need quiet, you
have a couple of options.
• You can choose to silence all your glucose and signal loss alarms for a set
period by turning on Silent Mode (if available).
• You can individually select to turn off the Override Do Not Disturb
setting for the High Glucose, Low Glucose, or Signal Loss Alarm if you
want the alarm to follow your phone's volume setting and be silent
when you have Do Not Disturb enabled.
Note: The Urgent Low Glucose Alarm can only be silenced by turning on
Silent Mode.
Optional Glucose Alarms: Low Glucose and High Glucose Alarms are
turned on by default, but can be turned off or customized to alarm at
different glucose levels.

92
 Urgent Low Glucose: Urgent Low Glucose Alarm will be delivered when
your glucose goes below 55 mg/dL. This alarm cannot be turned off or
customized but can be silenced with your other glucose alarms for a set
period.
Optional Signal Loss Alarm: Signal Loss Alarm will be delivered when
your Sensor isn’t communicating with the App. This alarm is turned on by
default, but can be turned off or customized.
Fixed System Alarms: Replace Sensor and Sensor Ended Alarms will be
delivered when your Sensor needs to be replaced, and the Check Sensor
Alarm will be delivered when the Sensor tip may not have been inserted
under the skin. These alarms are a little different and will always sound
regardless of your phone's sound, Do Not Disturb, or Silent Mode settings.
These alarms cannot be modified or turned off and indicate you are no
longer receiving glucose readings or glucose alarms.
Note: The iPhone app includes an App Stopped Alarm to indicate you
have force closed the App.

93
Please read all the information in this section before setting and using
alarms.

CAUTION:
• For you to receive alarms, your phone should be within 33 feet of
you at all times. The transmission range is 33 feet 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.
• For iPhone, 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.
• Your phone must have a Bluetooth connection with your Sensor
to receive glucose readings and glucose alarms. In the phone
settings, keep Bluetooth ON. For iPhones, in the phone settings
for the App, allow the App to access Bluetooth.

94
 • Check to make sure that you have the correct phone settings and
permissions enabled. If your phone is not configured properly, you
will not be able to use the App, so you will not receive alarms or be
able to check your glucose.
o iPhones are to be configured as follows:
■ In the phone settings for the App under Notifications, keep
Allow Critical Alerts ON

o Android Phones are to be configured as follows:

■ In the phone settings for the App, keep Do Not Disturb Access
permission ON
• If your phone is not configured correctly, the App will be in "Alarms
Unavailable" state and you will not be able to check your glucose
or receive any alarms, including the Urgent Low Glucose Alarm.
• To turn on Critical Alerts (iPhone) / Do Not Disturb Permission
(Android Phone), follow the instructions in the App.

95
• If you adjust the phone ringer volume (iPhone) or Media volume
(Android Phone) to silent or use the phone do not disturb setting,
keep ‘Override Do Not Disturb’ setting in the App ON for Low
Glucose, High Glucose, and Signal Loss Alarms to ensure you
receive audible alarms.
• 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.

96
 IMPORTANT:
• The Urgent Low, Low, and High Glucose Alarms should not be used
exclusively to detect low or high glucose conditions. The glucose
alarms should always be used along with your current glucose,
glucose trend arrow, and glucose graph.
• Low and High Glucose Alarm levels are different from your Target
Glucose Range values. Low and High Glucose Alarms tell you when
your glucose has passed the level you set in the alarm. Your Target
Glucose Range is displayed on glucose graphs in the App and used
to calculate your Time in Ranges.
• Make sure your phone is near you. The Sensor itself will not issue
alarms.
• If the Sensor is not communicating with the App, you will
not receive glucose alarms, and you may miss detecting low
glucose or high glucose episodes. You will see the symbol on
the screen when the Sensor is not communicating with the App. If
the Signal Loss Alarm is on, you will be notified if your Sensor has
not communicated with the App for 20 minutes.

97
• If you see the symbol, this means you are not getting alarms.
Confirm your settings are as follows:
iPhone settings:
o Allow Notifications is ON
o Lock screen and Banners alerts are ON
o Notifications sounds are ON

Android Phone settings:

o Lock screen notifications are ON
o Channel notifications or Pop-up notifications are ON
o Battery optimization is OFF
o Phone Media volume is ON

If alarms are unavailable because of any of these settings you will

still be able to check your glucose. Touch the symbol for more
information.

98
 Setting App Alarms
To access your alarm settings, go to the Main Menu and tap Alarms.
Work with your health care professional to determine your alarm
settings.



 

 
   



   

 



   

 

   



 



99
Silent Mode (if available)

Step Action

1 Silent Mode is off by default. If you want to turn it on, touch the
slider.

2 Tap the time field to set the duration. Tap SAVE.

3 Tap TURN ON to confirm.

Note: You can turn Silent Mode off at any time before the end
of the set duration.

IMPORTANT: When Silent Mode is enabled, you will not

hear your glucose and signal loss alarms even if you've
turned on 'Override Do Not Disturb'. You may still get the
visual and vibratory notifications based on your phone's
settings.

100
 Low Glucose Alarm
Step Action

1 T he Low Glucose Alarm is on by default. The alarm level is

initially set to 70 mg/dL. Tap to change this value between
60 mg/dL and 100 mg/dL. If the alarm is on, you will be notified
when your glucose falls below the level you set. Tap the slider to
turn the alarm off. Tap SAVE.

2 Choose the sound for this alarm. Tap SAVE.

3 Override Do Not Disturb for the alarm is on by default. Keep

Override Do Not Disturb ON if you want the alarm to play a
sound and appear on the lock screen even if your phone is
muted or Do Not Disturb is on. The alarm vibration will match
your phone setting. You won't hear a sound if you have turned
on Silent Mode.

101
Step Action

4 Tap the back button to  Low Glucose Alarm

 
Low Glucose Alarm On

return to the main alarm 

ALARM

settings screen.
  
When glucose goes below 70 mg/dL


SOUNDS
 

Alarm Tone Custom

   

Override Do Not Disturb On
   
   
    Turn ON if you want this alarm to always play a sound even if
your phone is muted or Do not disturb is on.

(Example screen (Example screen displayed

displayed for iPhone) for Android Phone)

102
 High Glucose Alarm
Step Action

1 T he High Glucose Alarm is on by default. The alarm level is

initially set to 250 mg/dL. Tap to change this value between
120 mg/dL and 400 mg/dL. If the alarm is on, you will be
notified when your glucose rises above the level you set.
Tap the slider to turn the alarm off. Tap SAVE.

2 Choose the sound for this alarm. Tap SAVE.

3 Override Do Not Disturb for the alarm is on by default. Keep

Override Do Not Disturb ON if you want the alarm to play a
sound and appear on the lock screen even if your phone is
muted or Do Not Disturb is on. The alarm vibration will match
your phone setting. You won't hear a sound if you have turned
on Silent Mode.

103
Step Action

4 Tap the back button to

 High Glucose Alarm

 
High Glucose Alarm On

return to the main alarm 

ALARM

settings screen.
   

When glucose goes above 250 mg/dL


SOUNDS

  

Alarm Tone Custom

  
Override Do Not Disturb On
   
   Turn ON if you want this alarm to always play a sound even if
  your phone is muted or Do not disturb is on.

(Example screen (Example screen displayed

displayed for iPhone) for Android Phone)

104
 Signal Loss Alarm
Step Action

1 I f the alarm is on, you will be notified when your Sensor has not
communicated with the App for 20 minutes and you are not
receiving glucose readings, Urgent Low, Low, or High Glucose
Alarms. Tap the slider to turn the alarm off.

2 Choose the sound for this alarm. Tap SAVE.

3 Override Do Not Disturb for the alarm is on by default. Keep

Override Do Not Disturb ON if you want the alarm to play a
sound and appear on the lock screen even if your phone is
muted or Do Not Disturb is on. The alarm vibration will match
your phone setting. You won't hear a sound if you have turned
on Silent Mode.

105
Step Action

4 Tap the back button to 

    

Signal Loss Alarm

return to the main alarm

Receive a Signal Loss Alarm when your glucose
       alarms are not available because the Sensor is not
     communicating with the App.

settings screen. 


 Signal Loss Alarm

SOUNDS
On


  Alarm Tone Custom

    Override Do Not Disturb On

         
      Turn ON if you want this alarm to always play a sound even if
    your phone is muted or Do not disturb is on.

(Example screen (Example screen displayed

displayed for iPhone) for Android Phone)

106
 Using App Alarms
What you see What it means

LIBRE 3 now Notifies you if your glucose drops

Urgent Low Glucose Alarm below 55 mg/dL. Open the App or
54 mg/dL
tap the Dismiss button to dismiss the
alarm. You will receive the Urgent Low
Glucose Alarm every 30 minutes until
your glucose reading is at or above
55 mg/dL.

LIBRE 3 now Notifies you if your glucose drops

Low Glucose Alarm below the level you set. Open the App
67 mg/dL
or tap the Dismiss button to dismiss
the alarm. You will only receive one
alarm per low glucose episode.

107
 What you see What it means

LIBRE 3 now Notifies you if your glucose rises above

High Glucose Alarm the level you set. Open the App or
251 mg/dL
tap the Dismiss button to dismiss the
alarm. You will only receive one alarm
per high glucose episode.

LIBRE 3 now Notifies you if your Sensor has not

Signal Loss Alarm communicated with the App for
Glucose alarms are not available.
20 minutes and you are not receiving
glucose readings or Urgent Low, Low,
or High Glucose Alarms. Signal loss
could be caused by the Sensor being
too far away from your phone (over
33 feet) or another issue such as an
error or problem with your Sensor.
Open the App or tap the Dismiss
button to dismiss the alarm.

108
 What you see What it means

LIBRE 3 now Notifies you if your Sensor has ended.

Replace Sensor You will not receive glucose alarms
Your Sensor is not working.
Please remove your Sensor and after this time unless you start a new
start a new one. Sensor. Remove your Sensor and start
a new Sensor to check your glucose.
Open the App or tap the Dismiss
button to dismiss the alarm.

LIBRE 3 now Notifies you if your Sensor has ended.

Sensor Ended You will not receive glucose alarms
Open the app to start a new Sensor.
after this time unless you start a new
Sensor. Remove your Sensor and start
a new Sensor to check your glucose.
Open the App or tap the Dismiss
button to dismiss the alarm.

109
 What you see What it means

LIBRE 3 now Notifies you if the App has been

App Stopped closed. The App must be running in
The app must be running in the
background to receive alarms. the background to receive alarms. Tap
Tap to re-open the app. the alarm to re-open the App.
(iPhone only)

Note: For all alarms except the Sensor Ended Alarm and App
Stopped Alarm: If you ignore an alarm, you will receive it again in
5 minutes if the condition still exists. Only your most recent alarms
will display on your screen.

110
 Adding Notes to Glucose Readings
Notes can be saved with your glucose readings to help you track things
like food, insulin, and exercise.
Adding Notes in the Reader
You can add a note at the time of your glucose reading or within 15
minutes after your reading was obtained.
Step Action

1 Glucose Going
F rom the Glucose Reading screen, add notes
by touching the symbol in the upper right
Low

350
72 mg
dL
corner of the touchscreen. If you do not want to
add notes, you can press the Home Button to go
250

150
to the Home Screen or hold the Home Button to
50
10am 4pm 10pm
turn the Reader off.

111
 Step Action

2 Select the checkbox next to the notes

Add Notes OK

Rapid-Acting
Insulin + you would like to add. Touch the down
Long-Acting
Insulin + Enter Rapid-Acting OK
arrow to view other note options. After
Insulin
you check the box for food and insulin
Food
+
1/2
notes, the + symbol appears to the
units right of the note. You can touch it to
add more specific information to your
note. Then touch OK.
• Insulin notes: Enter the number of units
taken.
• Food notes: Enter grams or serving
information.
Note: Food and insulin notes are shown on your
glucose graphs and in your Logbook as symbols.

3 Add Notes OK
Touch OK to save your notes.
Rapid-Acting
Insulin +
Long-Acting
Insulin +
Food
+
1/2

You can review your notes from the Logbook. See Reviewing Your History
section for more information.
112
 Adding Notes in the App
In the App, notes can be saved with your glucose readings to help you
track food, insulin, and exercise. You can also add your own comment.
Step Action

1 Tap the symbol on the Home Screen.

2 Select the checkbox next to the notes you would like to add.
After you check the box, you can add more specific information
to your note.
• Food notes: Enter meal type and grams or serving information
• Insulin notes: Enter the number of units taken
• Exercise notes: Enter intensity and duration

113
Step Action

3 Tap DONE to save your note.

Notes you add are shown on your glucose graph and in
your Logbook as symbols. Low or High Glucose Alarms you
receive will also be shown in the Logbook. You can review
a note by tapping its symbol on your glucose graph or by
going to the Logbook. See Reviewing Your History section for
more information about the Logbook. To edit a note from
the glucose graph, tap the symbol and then tap the . Tap
DONE when you are finished.

Food Exercise

Insulin (Rapid or
Food + Insulin
Long-acting)
Multiple/Custom notes – indicates different types
of notes entered together or notes entered within a
short period of time. A numbered badge next to
the symbol indicates the number of notes.

114
 Reviewing Your History
Reviewing and understanding your glucose history can be an important
tool for improving your glucose control. The Reader and App store
about 90 days of information and have several ways to review your past
glucose readings, notes, past alarm data, and other information.

IMPORTANT:
• Work with your health care professional to understand
your glucose history.
• Remember that FreeStyle Libre 3 app and FreeStyle Libre 3
Readers do not share data.

Reviewing Your History in the Reader

Step Action

1 Press the Home Button to turn on the Reader.

115
Step Action

2 10:23pm
No Active Sensor Touch the Review History icon.
View Glucose

Review History

Start New Sensor

3 Review History Use the arrows to view the available options.

Logbook

Daily Graph
Daily Patterns
Average Glucose
Time In Target
1/2

Low Glucose Events

Sensor Usage

116
 Logbook

Logbook OK The Logbook contains entries for notes you added

23 Feb
10:23am 143
as well as each time you received an Urgent Low,
23 Feb
98
Low, or High Glucose Alarm. If you entered Notes
6:37am

22 Feb
108
with a glucose reading, the symbol appears in
11:09pm
mg/dL that row. For more information about the symbols,
see Reader Symbols section.
Touch the entry to review the detailed information,
including any Notes you entered.

117
Daily Graph

Daily Graph OK A graph of your Sensor glucose readings by day.

(mg/dL)
350 The graph shows your Target Glucose Range and
250
symbols for notes you have entered.
150

50 Note:
12
am
12
pm
22 Feb
12
am
• While Sensor glucose readings are gathered in
the System range of 40-400 mg/dL, the Daily
Wednesday

Graph display range is 0-350 mg/dL for ease

of review on screen. Glucose readings above
350 mg/dL are displayed as 350 mg/dL. For
sequential readings above 350 mg/dL, a line is
displayed at 350 mg/dL.
• The symbol may appear indicating the
Reader time was changed. Gaps in the graph
may result or glucose readings may be hidden.

118
 Other History Options
Use the arrows to view information about your last 7, 14, 30, or 90 days.

Average Glucose OK Information about the average of your Sensor

Average: 119 mg/dL glucose readings. The overall average for the time
121
152
134 is displayed above the graph. The average is also
69 shown for four different 6-hour periods of the day.
Readings above or below your Target Glucose
12 12 12
am pm am

Range are yellow, while readings in range are green.

Last 7 Days

Average Glucose

Daily Patterns OK A graph showing the pattern and variability of your

(mg/dL)
350 Sensor glucose over a typical day. The thick black
250
line shows the median (midpoint) of your glucose
150

50
readings. The gray shading represents a range
12
am
12
pm
12
am (5-95 percentiles) of your Sensor readings.
Last 7 Days
Note: Daily Patterns needs at least 5 days of
Daily Patterns glucose data.

119
 Time In Target OK A graph showing the percentage of time your
Above 34%
Sensor glucose readings were above, below, or
In Target 54% within certain glucose ranges. The graph is based
Below 12%
Target Range
on your Target Glucose Range.
80-140 mg/dL

Last 7 Days

Time In Target

Low Glucose OK
Information about the number of low glucose
Events
Total Events: 10
events measured by your Sensor. A low glucose
6 event is recorded when your Sensor glucose
1
3
reading is lower than 70 mg/dL for 15 minutes or
longer. The total number of events is displayed
0
12 12 12
am pm am

Last 7 Days above the graph. The bar graph displays the low
Low Glucose Events
glucose events in four different periods of the
day.

Sensor Usage OK
Information about how often you viewed
Views Per 5 your Sensor glucose readings and how much
Day
Time Sensor
information has been captured from your Sensor.
is Active 100%

Last 7 Days

Sensor Usage

120
 Reviewing Your History in the App
F rom the Main Menu, tap Logbook to view the Logbook or tap on one of
the other history options under Reports.

Logbook

The Logbook contains entries for notes you added as well as each
time you received an Urgent Low, Low, or High Glucose Alarm. If
you would like to view a different day, tap the symbol or use
the arrows. To add a note to a Logbook entry, tap on the entry
and then tap the symbol. Select your note information and tap
DONE.
To add a note that is independent of a Logbook entry, tap the
symbol on the main Logbook screen. Tap the symbol if you
want to add a note on a different date.

121
Other History Options

Daily Patterns: A graph showing the pattern and variability of your

Sensor glucose readings over a typical day. The thick black line shows
the median (midpoint) of your glucose readings. The light blue
shading represents the 5th - 95th percentile range of your glucose
readings. Dark blue shading represents the 25th - 75th percentile
range.
Note: Daily Patterns needs at least 5 days of glucose data.

Time In Ranges: A graph showing the percentage of time your

Sensor glucose readings were above, below, or within certain
glucose ranges. The Custom graph is based on your Target Glucose
Range, and the Standard graph is based on a Target Range of 70 to
180 mg/dL.

Low Glucose Events: Information about the number of low glucose

events measured by your Sensor. A low glucose event is recorded
when your Sensor glucose reading is lower than 70 mg/dL for longer
than 15 minutes. The total number of events is displayed below the
graph. The bar graph displays the low glucose events in different
periods of the day.

122
 Average Glucose: Information about the average of your Sensor
glucose readings. The overall average for the selected time period is
displayed below the graph. The average is also shown for different
periods of the day. Readings above or below your Target Glucose
Range are yellow, orange, or red. Readings in range are green.

Daily Graph: A graph of your Sensor glucose readings by day. The

graph shows your Target Glucose Range and symbols for notes you
have entered.
• Glucose readings above 350 mg/dL are displayed as 350 mg/dL.
For sequential readings above 350 mg/dL, a line is displayed at
350 mg/dL.
• The symbol may appear indicating a time change. Gaps in the
graph may result or glucose readings may be hidden.

Sensor Usage: Information about how often you viewed your Sensor
glucose readings in the App and how much information has been
captured from your Sensor.

123
 Glucose Management Indicator (GMI): Glucose Management
Indicator uses average Sensor glucose data. GMI* can be used as an
indicator of how well your glucose levels have been controlled.
*The formula is based on the published reference:
GMI (%) = 3.31 + 0.02392 x (mean glucose mg/dL)
GMI (mmol/mol) = 12.71 + 4.70587 x (mean glucose mmol/L)
Reference: Bergenstal, Richard M. et al. “Glucose Management Indicator (GMI): A New
Term for Estimating A1C From Continuous Glucose Monitoring.” Diabetes Care, ADA,
November 2018.

Note:
• Tap the symbol (iPhone) or symbol (Android Phone) on any
report to share a screenshot of the report.
• Tap the symbol to view a description of the report.
• To view a different report, tap the dropdown menu above the report,
or go to the Main Menu.
• On all reports except the Daily Graph, you can select to show
information about your last 7, 14, 30, or 90 days.

124
 Removing Your Sensor
Step Action

1  ull up the edge of the adhesive that keeps your

P
Sensor attached to your skin. Slowly peel away
from your skin in one motion.
Note: Any remaining adhesive residue on the
skin can be removed with warm soapy water or
isopropyl alcohol.

2  iscard the used Sensor following directions from your health

D
care professional. See Maintenance and Disposal section.
When you are ready to apply a new Sensor, follow the
instructions in Applying Your Sensor and Starting Your Sensor
sections. If you removed your last Sensor before it ended, go to
"Start New Sensor" in the menu to start the new one. You
will be prompted to confirm that you would like to start a new
Sensor.
Note: After removing your Sensor you may observe a slight
bump at the insertion site. This goes away quickly, usually in a
day or two.

125
 Replacing Your Sensor
Your Sensor automatically stops working after the wear duration and must
be replaced. You should also replace your Sensor if you notice any irritation
or discomfort at the application site or if your device reports a problem
with the Sensor currently in use. Taking action early can keep small
problems from turning into larger ones.

CAUTION: If the Sensor is becoming loose or if the Sensor tip is

coming out of your skin, you may get no readings or unreliable
readings, which may not match how you feel. Check to make
sure your Sensor has not come loose. If it has come loose,
remove it, apply a new one, and contact Customer Service.
Customer Service is available at 1-855-632-8658 7 Days a Week
from 8AM to 8PM Eastern Time; excluding holidays.

126
 Using Reminders
You can create single or repeating reminders to help you remember things
like checking your glucose or taking insulin. You can also set a reminder to
remind you to check your alarm settings if you have turned off any of your
alarms temporarily.
Using Reminders in the Reader
Step Action

1 10:23pm
Ends in 14 days
From the Home Screen, touch the Settings
symbol .
View Glucose

Review History Scroll down using the arrow and

Start New Sensor
Reminders
touch Reminders.
Control Solution Test

Language

2/4

2 Set Reminder T ouch to select which Type of reminder you

Type Other
want to set: Check Glucose, Take Insulin, or
Repeat Daily
Other, which is a general reminder to help you
remember something.
Time XX:XX

cancel save

127
Step Action

3 T ouch to select how often you want the reminder to Repeat:

Once, Daily, or Timer.
Note: You can set the reminders for a specific time (e.g. 8:30am)
or as a timer (e.g. 3 hours from the current time).

4 S et the reminder Time using the arrows on the touchscreen.

Touch save.

5 Reminders F rom the Reminders screen, you can turn the

8:30am On reminder On/Off or add new reminders.
12:30pm Off Touch done to return to the Home Screen.
00:00:00 On

add new done

Reminder You will get your reminder even if the Reader is turned
off. Touch OK to dismiss your reminder or snooze to be
12:30pm reminded again in 15 minutes.
snooze
15 min OK
Note: Reminders will not appear if the Reader is
connected to a computer.

128
 Using Reminders in the App
Note: To receive reminders, make sure notifications for the App are
enabled. If you want to receive a sound/vibration with your reminder,
ensure that sound/vibration on your phone is turned on, sound is set at
a level you can hear, and your phone’s Do Not Disturb feature is turned
off. If Do Not Disturb is on, you will only see your reminder on the screen.

Step Action

1 To add a new reminder, go to the Main Menu and tap

Reminders. Tap ADD REMINDER.

2 Name your reminder.

3 Tap the time fields to set the time for the





reminder.


7 41

8 42

Note: If you would like the reminder to

9 43 AM
10 44 PM
11 45
12
1
46
47
repeat, tap the slider to the right. You can

also select which days you would like to






receive the reminder.
 

 

 

(Example screen displayed for iPhone)

(Example screen
displayed for iPhone)

129
 Step Action

4 Tap DONE. You will now see your reminder on the list along
with the time you will receive it.

Note:
• There is one default reminder to help you remember to check your
glucose. This Check Glucose reminder can be changed or disabled but
cannot be deleted.
• To turn off a reminder, tap the slider to the left.
• To delete a reminder, swipe the reminder (swipe left for iPhones, swipe
right for Android Phones) and tap the symbol. The Check Glucose
reminder cannot be deleted.
• Your reminders will be received as notifications that you can swipe or
tap to dismiss.

130
 Using the Reader’s Built-in Meter
The Reader has a built-in meter that can be used to test your blood
glucose, or to test the meter and strips with control solution.

WARNING: Do NOT use the built-in meter while the

Reader is connected to an electrical outlet or a computer
due to the potential risk of electrical shock.

Intended Use
The FreeStyle Libre 3 Reader’s built-in meter is for use outside the body
only (in vitro diagnostic use) in the quantitative measurement of glucose
in fresh whole blood for self testing by lay users from the fingers. It is
not intended to be used for testing neonatal blood samples or for the
diagnosis or screening of diabetes.
The FreeStyle Libre 3 Reader’s built-in meter is indicated for the home (lay)
user in the management of patients with diabetes. It is intended to be used
by a single person and should not be shared.
The FreeStyle Precision Neo Blood Glucose Test Strips are for use with the
FreeStyle Libre 3 Reader’s built-in meter to quantitatively measure glucose
(sugar) in fresh capillary whole blood samples drawn from the fingertips.

131
IMPORTANT:
• Use only FreeStyle Precision Neo test strips. Other test strips may
produce inaccurate results.
• Read all the instructions in this section. Failure to follow
instructions may cause incorrect blood glucose results. Practice the
testing procedures before using the Reader’s built-in meter.
• Read the test strip instructions for use before performing your first
blood glucose test as they contain important information. They
also let you know how to store and handle the test strips and give
you information about sample types.
• The Reader’s built-in meter is not for use on people who
are dehydrated, hypotensive, in shock, or for individuals in
hyperglycemic-hyperosmolar state, with or without ketosis.
• The Reader’s built-in meter is not for use on neonates, in critically-ill
patients, or for diagnosis or screening of diabetes.
• Follow your health care professional’s advice when testing blood
glucose levels.
• Severe dehydration (excessive water loss) may cause false low test
strip results. If you believe you are suffering from dehydration,
consult your health care professional right away.

132
 IMPORTANT: (cont.)
• Inaccurate test strip results may occur in severely hypotensive
individuals or patients in shock.
• Inaccurate test strip results may occur for individuals experiencing a
hyperglycemic-hyperosmolar state, with or without ketosis.
• Observe caution when using around children. Small parts may
constitute a choking hazard.
• You should clean and disinfect the Reader once per week. The
Reader should also be cleaned and disinfected prior to being
handled by any person providing testing assistance to the user.
• The Reader is for use by a single person. It must not be used on
more than one person including other family members due to the
risk of spreading infection. All parts of the Reader are considered
biohazardous and can potentially transmit infectious diseases, even
after performing the cleaning and disinfection procedure.1, 2
• Use the Reader’s built-in meter within the test strip operating
temperature range (59˚F – 104˚F) or you will see Error Message E-1.
• Use a test strip immediately after removing from its foil packet.
• Only use a test strip once.

133
IMPORTANT: (cont.)
• Do not put urine on the test strip.
• Do not use expired test strips as they may cause inaccurate results.
• Do not use at altitudes higher than 10,000 feet above sea level.
• Do not use a wet, bent, scratched, or damaged test strip.
• Do not use the test strip if the foil packet has a hole or is torn.
• Results from the built-in meter are shown only in your Logbook
and not in other history options.
• Refer to your lancing device instructions for use for how to use
your lancing device.
• This device is not intended for use with multiple patients in health
care or assisted-use settings such as hospitals, physician offices, or
long-term care facilities because it has not been cleared by FDA
for use in these settings, including for routine assisted testing or as
part of glycemic control procedures. Use of this device on multiple
patients may lead to transmission of Human Immunodeficiency
Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other
bloodborne pathogens.

134
 Blood Glucose Testing
You can use the built-in meter to check your blood glucose, whether you
are wearing a Sensor or not. Be sure to read the test strip instructions for
use prior to using the built-in meter.
Step Action

1
CAUTION: Test on your fingers in accordance
with the Intended Use in this section.

 ash your hands with warm soapy water for

W
accurate results. Thoroughly dry your hands.
To warm the site, apply a warm dry pad or rub
vigorously for a few seconds.
Note: Do not use lotion or cream on the test
site. Avoid moles, veins, bones, and tendons.
Bruising may occur at the test site. If you get a
bruise, consider selecting another site.

135
Step Action

2  heck the test strip expiration date. Do not use expired test
C
strips as they may give inaccurate results.

3 Abbott Diabetes Care Ltd.

Witney, Oxon, OX29 0YL
Range Road
Made in UK.

 pen the foil test strip packet at the notch and

O
tear down to remove the test strip. Use the test
4˚C
Abbott Diabetes Care Ltd.
Witney, Oxon, OX29 0YL
Sensor Electrode
Blood Glucose

Range Road
Made in UK.

strip immediately after removing from the foil

packet.

4 I nsert the test strip with the three black lines at

the end facing up. Push the strip in until it stops.
Note: The Reader’s built-in meter turns off after 2
minutes of inactivity.

136
 Step Action

5 Apply Blood  se your lancing device to obtain a blood drop

U
and apply blood to the white area at the end
of the test strip. Refer to your lancing device
instructions for use if you need help using your
lancing device.
If sounds are turned on, the Reader beeps once
to let you know you have applied enough blood.
You will see a butterfly on the screen while you
wait for your result. Do not remove the test strip
while the butterfly is on the screen. If sounds are
turned on, the Reader beeps once when your
result is ready.
If the butterfly does not appear, you may not
have applied enough blood to the test strip.
Apply a second drop of blood to the test strip
within 5 seconds of the first drop. If the butterfly
still does not appear or if more than 5 seconds
have passed, discard the test strip. Turn off the
Reader and repeat the steps in this section with a
new test strip.

137
Step Action

5 Note:
(cont.) • E-3 means the blood drop is too small, or incorrect test
procedure, or there may be a problem with the test strip.
• E-4 means the blood glucose level may be too high to be read
by the system or there may be a problem with the test strip.
See Troubleshooting section for more information.

6 After reviewing your result, remove and discard the used test
strip according to local regulations.

IMPORTANT: After performing a blood glucose test, wash

your hands with soap and water and thoroughly dry them.

10:23pm Your Blood Glucose Results

Blood glucose results are marked on the

143 mg
dL
results screen and in the Logbook with the
symbol.
Note: Contact your health care professional if
you have symptoms that do not match your test
results.

Example Screen Only

138
 IMPORTANT: The built-in meter displays results from
20 - 500 mg/dL. Low or high blood glucose results can
indicate a potentially serious medical condition.

The normal glucose level for a non-diabetic adult is below 100 mg/dL
when fasting, and less than 140 mg/dL within two hours of a meal.3
Consult your health care professional to determine the range that is
appropriate for you.

Display What To Do

Low Glucose If LO appears on the Reader, your result is lower

than 20 mg/dL. If HI appears on the Reader, your
LO mg
dL result is higher than 500 mg/dL. You can touch the
High Glucose
message button for more information. Check your
blood glucose again with a test strip. If you get a
HI mg
dL
second LO or HI result, contact your health care
professional immediately.

139
 Display What To Do

Low Glucose If your glucose is higher than 250 mg/dL or lower

than 70 mg/dL, you will see a message on the
63 mg
dL screen. You can touch the message button for
High Glucose
more information and set a reminder to check
your glucose.
289 mg
dL

After you get your blood glucose result, you can add Notes by touching
the symbol. If you do not want to add a Note, press the Home Button
to go to the Home Screen or hold the Home Button to turn the Reader off.

IMPORTANT: You should clean and disinfect your Reader once

per week. Refer to the Maintenance and Disposal section for
instructions.

140
 Accuracy of the Reader's built-in meter
Results from the Reader's built-in meter may vary slightly from your
actual blood glucose value. This may be due to slight differences in
technique and natural variation in test technology. The table below
shows the results of a study where 119 typical users used the built-in
meter to check their blood glucose level. For example, in the study, the
built-in meter gave results within 15% of true blood glucose level 115
out of 119 times.
Accuracy results for all glucose concentrations
Difference
range between
the true blood Within ± 5 mg/dL Within ± 10 mg/dL Within ± 15 mg/dL Within ± 15 mg/dL
glucose level and 5% and 10% and 15% and 20%
and the built-in
meter result
The number
and percent
that match true 68/119 (57.1%) 105/119 (88.2%) 115/119 (96.6%) 116/119 (97.5%)
blood glucose
level within X%

141
Control Solution Testing
You should do a control solution test when you are not sure of your test
strip results and want to check that your Reader’s built-in meter and test
strips are working properly.

IMPORTANT:
• Control solution results should fall within the control solution range
printed on the test strip instructions for use.
• Do NOT use control solution past the expiration date. Discard
control solution 3 months after opening or on the expiration date
printed on the bottle, whichever comes first. (Example: open April
15, discard July 15; write the discard date on the side of the bottle.).
• The control solution range is a target range for control solution
only, not for your blood glucose results.
• The control solution test does not reflect your blood glucose level.
• Use only MediSense (low, medium or high) Glucose and Ketone
Control Solution with the Reader’s built-in meter.
• Check that the LOT number printed on the test strip foil packet and
instructions for use match.
• Replace the cap securely on the bottle immediately after use.
• Do NOT add water or other liquid to the control solution.
• Contact your FreeStyle Libre 3 System provider (pharmacy or mail
order supplier) for how to obtain control solution.

142
 Step Action

1 10:23pm
Ends in 14 days
From the Home Screen, touch the Settings
symbol .
View Glucose

Review History Scroll down using the arrow and

Start New Sensor
Reminders
touch Control Solution Test.
Control Solution Test

Language

2/4

2 Check the test strip expiration date.

3  pen the foil test strip packet at the notch and

O
Abbott Diabetes Care Ltd.
Witney, Oxon, OX29 0YL
Range Road
Made in UK.

tear down to remove the test strip.

4˚C
Abbott Diabetes Care Ltd.
Witney, Oxon, OX29 0YL
Sensor Electrode
Blood Glucose

Range Road
Made in UK.

143
Step Action

4 I nsert the test strip with the three black lines

facing up. Push the strip until it stops.
Note: The Reader’s built-in meter turns off after 2
minutes of inactivity.

5 Apply Control Solution Shake the control solution bottle to mix the
solution. Apply a drop of control solution to the
white area at the end of the test strip.
If sounds are turned on, the Reader beeps once
to let you know that you have applied enough
control solution.

144
 Step Action

5 You will see a butterfly on the screen while you

(cont.) wait for the result. Do not remove the test strip
while the butterfly is on the screen. If sounds are
turned on, the Reader beeps once when the result
is ready.
If the butterfly does not appear, you may not have
applied enough control solution to the test strip.
Apply a second drop of control solution to the
test strip within 5 seconds of the first drop. If the
butterfly still does not appear or if more than 5
seconds have passed, discard the test strip. Turn
off the Reader and repeat the steps in this section
with a new test strip.

145
 10:23pm Control Solution Results
Compare the control solution result to the range

100 mg
dL
printed on the test strip instructions for use. The
result on your screen should be in this range.
Control solution results are marked on the
Control Solution Test
results screen and in the Logbook with a
symbol.

Example Screen Only

Note: Repeat the control solution test if the results are outside
of the range printed on the test strip instructions for use.
Stop using the built-in meter if the control solution results are
repeatedly outside of the printed range. Contact Customer
Service. Customer Service is available at 1-855-632-8658 7 Days a
Week from 8AM to 8PM Eastern Time; excluding holidays.

146
 Living With Your System
Activities
Activity What You Need To Know
Bathing,
Showering, and CAUTION: Do NOT place the Reader in
Swimming water or other liquids as this may cause it
to not function properly and may lead to
risk of fire or burns.

Your Sensor is water-resistant and can be worn

while bathing, showering, or swimming.
Note: Do NOT take your Sensor deeper than
3 feet (1 meter) or immerse it longer than
30 minutes in water. Bluetooth performance
may be impacted if using the system while
underwater.

147
 Activity What You Need To Know
Sleeping Your Sensor should not interfere with your sleep.
Place your device nearby so you will receive
alarms and any reminders you have set.

Traveling by Air You may use your System while on an aircraft,

following any requests from the flight crew.

IMPORTANT: You will not receive alarms

or glucose readings while your phone is in
airplane mode unless you enable Bluetooth.

• The Reader is classed as a Medical-Portable

Electronic Device (M-PED) that meets all
required M-PED emission standards for safe use
onboard an aircraft: RTCA/DO160, Section 21,
Category M.

148
 Activity What You Need To Know
Traveling by Air • Some airport full-body scanners include x-ray or
(cont.) millimeter radio-wave, which you cannot expose
your Sensor to. The effect of these scanners
has not been evaluated and the exposure may
damage the Sensor or cause inaccurate results.
To avoid removing your Sensor, you may request
another type of screening. If you do choose to go
through a full-body scanner, you must remove
your Sensor.
• The Sensor can be exposed to common
electrostatic (ESD) and electromagnetic
interference (EMI), including airport metal
detectors. You can also keep your Reader on
while going through these.

149
 Activity What You Need To Know
Traveling by Air Note: Changing the time and date affects the
(cont.) graphs and statistics. The symbol may appear
on your glucose graph indicating a time change.
Gaps in the graph may result or glucose readings
may be hidden.
If you are changing time zones, you can change
the time and date settings on the Reader by
touching the Settings symbol from the Home
Screen, then Time & Date.

150
 Charging the Reader
A fully charged Reader battery should last up to 4 days. Your battery
life may vary depending on your usage. A Low Battery message
accompanies your result when you have enough charge remaining for
about one day of use.
CAUTION:
• Always use the Abbott provided power adapter and yellow USB
cable that came with your Reader to minimize the risk of fire or
burns. Take care when plugging and unplugging your USB cable.
Do not force or bend the end of the USB cable into the Reader's
USB port.
• Choose a location for charging where you can easily access the
power adapter and quickly disconnect to prevent the potential
risk of electrical shock.
• The maximum surface temperature of the Reader and/or the
power adapter could go as warm as 111°F when it's charging or
117°F during normal use. Under these conditions, do not hold
the Reader or the power adapter for five minutes or more. People
with disorders of peripheral circulation or sensation should use
caution at this temperature.
• Do NOT expose the USB cable or power adapter to water or other
liquids as this may cause them to not function properly and may
lead to risk of fire or burns.

151
Step Action

1 Before charging, to minimize the risk of fire or burns:

• Check the provided power adapter and yellow USB cable to
make sure they are not damaged.
• Check the Reader's USB port and make sure it is dry and free
of debris.

2 Plug the yellow USB cable into an electrical

outlet using the power adapter. Then, plug the
other end of the USB cable into the USB port on
the Reader.

Note:
• You must charge the Reader when the battery is low to keep
using the Reader.
• To fully charge the battery, charge the Reader for at least 3 hours.
• If the Reader does not turn on after being charged or you notice a
significant deterioration in battery life, contact Customer Service about
replacing your Reader, yellow USB cable, and power adapter. Customer
Service is available at 1-855-632- 8658 7 Days a Week from 8AM to 8PM
Eastern Time; excluding holidays.
• Fully charge your Reader before storing it for more than 3 months.

152
 Reader Settings and Information
You can go to the Settings menu to change many settings on the Reader,
like alarm settings, sound & vibration, time & date, and target range. The
Settings menu is also where you go to do a Control Solution Test or to
check the System Status.

Step Action

1 10:23pm
Ends in 14 days T o get to the Settings menu, touch the Settings
View Glucose
symbol on the Home Screen.
Review History
Settings
Start New Sensor

Alarms

Sound & Vibration

Time & Date

1/4

2 Touch the setting you want to change:

Alarms – See Reader Alarms section for information on setting
alarms
Sound & Vibration – Set Reader sound and vibration. These
also apply to alarms

153
Step Action

2 Time & Date – Change the Time or Date

(cont.) Reminders – See Using Reminders section for information on
setting reminders
Control Solution Test – Perform a control solution test
Language – Change the language on the Reader
System Status – Check Reader information and performance
• View System Information: The Reader will display information
about your System including:
o Current Sensor end date and time
o Reader serial number and version number
o Serial numbers and status codes of most recent Sensors (up
to three)
o Sensor version for most recent Sensor
o Number of Sensors that have been used with Reader
o Number of tests that have been performed using test strips

154
 Step Action

2 • View Event Logs: A list of events recorded by the

(cont.) Reader, which may be used by Customer Service to help
troubleshoot your System
• Perform a Reader Test: The Reader Test will perform internal
diagnostics and allow you to check that the Display is
showing all pixels, sounds and vibrations are working, and
the Touchscreen is responding when touched
Report Settings – Work with your health care professional to
set your Target Glucose Range, which is displayed on glucose
graphs on the Reader and used to calculate your Time In Target.
Your Target Glucose Range is not related to your alarm settings
Reader Basics – Review the information screens shown during
the Reader setup
Dose Increment – You can set the insulin dose increment
to either 1.0 or 0.5 units for use with insulin notes

App Settings and Other Menu Options

You can go to the Main Menu to change settings like your LibreView
password. You can also access the Connected Apps option, Help, and
information about the App.

155
App Settings:
Unit of Measurement – View the glucose unit of measure used in the
App.
Report Settings – Work with your health care professional to set your
Target Glucose Range, which is displayed on glucose graphs in the App
and used to calculate your Time In Ranges Custom report. The Target
Glucose Range setting will not set glucose alarm levels. Tap SAVE
when you are done.
Carbohydrate Units – Choose grams or servings for food notes that
you enter. Tap SAVE when you are done.
Account Settings:
Note: You must have a LibreView account and be signed in to manage
Account Settings. To sign into an existing account or create a new
account choose Sign In from the Main Menu. Not all Account Settings
may be available, depending on your app version.
Account Settings – View/change your LibreView account information.
Account Password – Change your LibreView account password.
Sign Out – Sign out of your LibreView Account.
Account Options – Sign out or delete your LibreView account.
Signing out of your account means you will no longer be able to:
• Use the account with the FreeStyle Libre 3 app unless you sign back
in.

156
 • Use the Connected Apps or Account Settings features.
Deleting your account means you will no longer be able to:
• Use your current Sensor.
• Access your account and all related data. Data will be deleted and
cannot be recovered for future use.
• Use the account with the FreeStyle Libre 3 app.
• Use the Connected Apps or Account Settings features.
Connected Apps:
The Connected Apps option in the Main Menu opens a web browser
within the App. It lists different apps you can connect with to share
your data. To connect your data with apps listed in the Connected
Apps option, select them from the list of apps, and follow the onscreen
instructions.
Help:
View in-app tutorials, access the product labeling, and review the
App’s legal information. You can also view the Event Log, which is a list
of events recorded by the App. This may be used by Customer Service
to help troubleshoot.
About:
View App software version and other information.

157
 Maintenance and Disposal
Cleaning and Disinfecting the Reader
Cleaning and disinfecting your Reader is important to prevent the spread
of infectious diseases. The Reader has a mean use life of 3 years and has
been validated for 156 cleaning and disinfection cycles (the equivalent of
1 cycle per week for 3 years).
You should clean and disinfect the Reader once a week. The Reader should
also be cleaned and disinfected prior to being handled by any person
providing testing assistance to the user.
Cleaning is the physical removal of organic soil from the Reader surfaces.
Keeping the Reader clean helps ensure that it is working properly and
that no dirt gets in the device. Cleaning allows for successful, subsequent
disinfection.
Disinfection is a process that destroys pathogens, such as viruses and other
microorganisms, on the Reader surfaces. Disinfecting the Reader helps
ensure that no infection is passed on when you or others come in contact
with the Reader.

158
 This device is not intended for use with multiple patients in health care or
assisted-use settings such as hospitals, physician offices, or long-term care
facilities because it has not been cleared by FDA for use in these settings,
including for routine assisted testing or as part of glycemic control
procedures.
Use of this device on multiple patients may lead to transmission of
Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B
Virus (HBV), or other bloodborne pathogens.
To clean and disinfect your Reader, you will need Clorox Healthcare Bleach
Germicidal Wipes, EPA Reg. #67619-12.
These disinfectant wipes contain a 0.55% Sodium Hypochlorite (NaOCl)
solution and have been shown to be safe for use with the Reader. They
may be purchased at major online retailers, such as Walmart.com,
Amazon.com, and OfficeDepot.com.
Note: Additional information about the risks for transmitting bloodborne
pathogens to persons undergoing fingerstick procedures for blood
sampling can be found. See References section for more information.

159
Step Action
Turn off the Reader before you clean and disinfect it.
1

 lean the outside surfaces of the Reader with a bleach wipe

C
2 until visibly clean. Make sure liquid does not get into the test
strip and USB ports.

For disinfection, use a second bleach wipe to wipe all outside

3 surfaces of the Reader until they are wet. Make sure liquid
does not get into the test strip and USB ports. Allow the
Reader surfaces to remain wet for 60 seconds.

4 Dry with clean paper towel to remove any residual moisture.

160
 Step Action

5 When finished, thoroughly wash your hands with soap and

water.

IMPORTANT: Do NOT use the Reader if you notice any signs of

deterioration on the Reader (such as clouding or crazing on the
display of the Reader, corroding, eroding or swelling of the plastic
housing, or cracking of plastic housing or display) or if the Reader
does not turn on. Contact Customer Service about replacing your
Reader. Customer Service is available at 1-855-632-8658 7 Days a
Week from 8AM to 8PM Eastern Time; excluding holidays.

CAUTION: Do NOT place the Reader in water or other liquids.

Avoid getting dust, dirt, blood, control solution, water, bleach,
or any other substance in the test strip or USB port as this may
cause the Reader to not function properly and may lead to risk
of fire or burns.

161
Maintenance
The System has no serviceable parts.
Disposal
This product should be disposed of in accordance with all applicable local
regulations related to the disposal of electronic equipment, batteries,
sharps, and materials potentially exposed to body fluids.
Contact Customer Service for further information on the appropriate
disposal of system components. Customer Service is available at
1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Time; excluding
holidays.

162
 Troubleshooting
This section lists problems that you may experience, the possible cause(s),
and recommended actions. If there is an error, a message will appear on
the screen with directions to resolve the error.

IMPORTANT: If you are having issues with the App, please

keep in mind that uninstalling the App will cause you to lose all
historical data on the App, and may end the Sensor currently
in use. Please call Customer Service if you have any questions.
Customer Service is available at 1-855-632-8658 7 Days a Week
from 8AM to 8PM Eastern Time; excluding holidays.

163
Reader Does Not Power On
Problem What It May Mean What To Do
Reader does not Reader battery is Charge the Reader.
power on after too low.
you press the
Home Button or
insert a test strip.

Reader is outside Move the Reader to a

of its operating temperature between
temperature range. 50°F and 113°F and then
try to power it on.

If the Reader still does not power on after trying these steps, contact
Customer Service. Customer Service is available at 1-855-632-8658
7 Days a Week from 8AM to 8PM Eastern Time; excluding holidays.
164
 Problems at the Sensor Application Site
Problem What It May Mean What To Do
The Sensor is The site is not free 1. Remove the Sensor.
not sticking of dirt, oil, hair, or 2. Clean the site with a plain
to your skin. sweat. soap and water and then
clean with an alcohol wipe.
3. Follow the instructions in
Applying and Starting Your
Sensor sections. Consider
shaving the site, avoiding use
of lotions prior to insertion,
and applying the Sensor to
your non-dominant arm.

Customer Service: 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Time; excluding holidays.
165
 Problem What It May Mean What To Do
Skin irritation Seams or other Ensure that nothing rubs on the
at the Sensor constrictive clothing site.
application or accessories
site. causing friction at
the site.

You may be sensitive If the irritation is where the

to the adhesive adhesive touches skin, contact
material. your health care professional to
identify the best solution.

Customer Service: 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Time; excluding holidays.
166
 Problems Starting Your Sensor or Receiving Sensor
Readings
Display What It May Mean What To Do
Scan Error The device was • iPhone: Tap the scan button
unable to scan the and try scanning the Sensor
Sensor. again. The NFC 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 affect NFC
performance. For example,
a bulky or metallic case
can interfere with the NFC
signal. Contact Customer
Service if the error persists
after repeated attempts of
scanning. Customer Service is
available at 1-855-632-8658
7 Days a Week from 8AM to
8PM Eastern Time; excluding
holidays.

Customer Service: 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Time; excluding holidays.
167
 Display What It May Mean What To Do
Scan Error •A  ndroid Phone: Try scanning
(cont.) the Sensor again. The NFC
antenna is located on the back
side of most Android phones.
Scan your Sensor by touching
the Sensor with the BACK of
your phone. Move your phone
around slowly if needed.
Proximity, orientation, and
other factors can affect NFC
performance. For example,
a bulky or metallic case
can interfere with the NFC
signal. Make sure you are not
touching any buttons on the
phone or the screen.
• Reader: Try scanning again.
You may need to move away
from potential sources of
electromagnetic interference.

Customer Service: 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Time; excluding holidays.
168
 Display What It May Mean What To Do
Sensor The Sensor was Both the Reader and App can
Already in started by another only be used with a Sensor that
Use device. it started. Check your glucose
with the device that started
it. Or, apply and start a new
Sensor.

Enable The Bluetooth Go to your phone settings and

Bluetooth setting on your enable Bluetooth.
phone is turned off.

Customer Service: 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Time; excluding holidays.
169
 Display What It May Mean What To Do
Incompatible The FreeStyle Libre 3 If you still have questions about
Sensor Reader and FreeStyle compatibility, tap "Learn more"
Libre 3 app can or call Customer Service.
only be used with
the FreeStyle Libre
3 Sensor. Check
that you are using
the App or Reader
that is compatible
with your Sensor.
You may need to
download a different
app if your Sensor is
not compatible.

Replace The System has Apply and start a new Sensor.

Sensor detected a problem
with your Sensor.

Customer Service: 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Time; excluding holidays.
170
 Display What It May Mean What To Do
Allow Access Access to Critical Follow the instructions on the
to Critical Alerts / Do Not screen to allow permission for
Alerts (iPhone) Disturb was Critical Alerts (iPhone) / Do
/ Allow disabled. Not Disturb (Android Phone).
Access to Do You will not be able to receive
Not Disturb Sensor readings or start a new
(Android Sensor until these permissions
Phone) are allowed.

Sensor ready The Sensor is unable Check again after the duration
in X minutes to provide a glucose specified on the screen.
reading during the
start-up period.

Customer Service: 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Time; excluding holidays.
171
 Display What It May Mean What To Do
Scan The Reader is not Bring the screen of the Reader
Timeout held close enough close to the Sensor.
(Reader only) to the Sensor.

Check Sensor The Sensor tip may Try to start your Sensor again.
not be under your If you see “Check Sensor” again
skin. on the screen, your Sensor was
not applied properly. Remove
this Sensor and apply and start
a new Sensor.

Sensor Ended The Sensor has Apply and start a new Sensor.
ended.

Customer Service: 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Time; excluding holidays.
172
 Display What It May Mean What To Do
Signal Loss Sensor has not Make sure your device is
automatically within 33 feet of the Sensor.
communicated with If using the App, make sure
your device in the you have not force closed the
last 5 minutes. App. Tap the symbol for
more information. Try turning
Bluetooth OFF then ON again.
If that doesn't work, try turning
your phone OFF then ON again.

Signal Loss Sensor has not Make sure your device is within
Alarm automatically 33 feet of the Sensor. If the
communicated with Signal Loss Alarm continues
your device in the to show, contact Customer
last 20 minutes. Service.

Bluetooth Off Bluetooth is turned Go to your phone settings and

off. enable Bluetooth.

Customer Service: 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Time; excluding holidays.
173
 Display What It May Mean What To Do
Sensor Error The Sensor is unable Check again after the duration
to provide a glucose specified in the message.
reading. Tap the
symbol for more
information.

Sensor Too Your Sensor is too Move to a location where the

Hot hot to provide a temperature is appropriate and
glucose reading. Tap check again in a few minutes.
the symbol for
more information.

Sensor Too Your Sensor is too Move to a location where the

Cold cold to provide a temperature is appropriate and
glucose reading. Tap scan again in a few minutes.
the symbol for
more information.

Customer Service: 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Time; excluding holidays.
174
 Display What It May Mean What To Do
Unexpected The App has Shut down the App completely
Application detected an and restart.
Error unexpected error.

New Sensor Sensor is not ready Wait until the Sensor start-up
Starting Up to read glucose. period has completed.
(Reader) or
New Sensor
Starting Up
(App)
New Sensor You scanned a new Your device can only be used
Found Sensor before your with one Sensor at a time. If
previous Sensor you start a new Sensor, you will
ended. no longer be able to use your
old Sensor. If you would like to
begin using the new Sensor,
select “Yes” and scan again.

Glucose Your Sensor is too Move to a location where the

Reading hot or too cold. temperature is appropriate and
Unavailable check your glucose again.
Customer Service: 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Time; excluding holidays.
175
Problems Receiving Alarms
Problem What It May Mean What To Do
You are not You have turned If using the Reader, touch the
receiving alarms off. Settings symbol and then
alarms. select Alarms. If using the App,
go to the Main Menu and then
select Alarms. Choose the alarm
you want to turn on and set.

Customer Service: 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Time; excluding holidays.
176
 Problem What It May Mean What To Do
You are not The Sensor is not The Sensor must be within range
receiving communicating with (33 feet) of your device for you
alarms. your device. to receive alarms. Make sure that
(cont.) or you are within this range. You
There may be a will see the symbol at the
problem with your top of the Home Screen (if using
Sensor or device. the Reader) and the symbol
at the top of the screen (if using
the App) when your Sensor has
not communicated with your
device in 5 minutes. If the Signal
Loss Alarm is on, you will be
notified if there has been no
communication for 20 minutes.
If the Signal Loss Alarm is on and
continues to show even when
your Sensor is in range of your
device, contact Customer Service.

Customer Service: 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Time; excluding holidays.
177
 Problem What It May Mean What To Do
You are not Sound/vibration are Check the Reader’s sound and
receiving turned off in your vibration settings to confirm
alarms. Reader settings. sound/vibration are on.
(cont.)
One or more of Check to make sure that you
the following is have the correct settings and
turned off in your permissions enabled on your
phone settings: phone to receive alarms.
Allow Critical Alerts,
Notifications, Lock
Screen and Banner
alerts, Notification
sounds, or general
phone sounds or
vibration.

Customer Service: 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Time; excluding holidays.
178
 iPhone settings:
• Bluetooth is ON
• Allow Critical Alerts is ON
• Allow Notifications is ON
• Lock Screen and Banner alerts are ON
• Notifications sounds are ON
Android Phone settings:
• Bluetooth is ON
• Lock Screen notifications are ON
• Channel notifications or Pop-up notifications are ON
• Battery Optimization is OFF
• Do Not Disturb access permission is ON
• Phone Media volume is ON
Go to Setting App Alarms section for more information.

Customer Service: 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Time; excluding holidays.
179
 Problem What It May Mean What To Do
You are not You have enabled Check your alarm settings to
receiving Silent Mode in the confirm Silent Mode is turned off.
alarms. App.
(cont.)

You may have set an Confirm your alarm settings are

alarm level that is appropriate.
higher or lower than
you intended.

You have already You will receive another alarm

dismissed this type when a new low or high glucose
of alarm. episode starts.

Your Sensor has Replace your Sensor with a new

ended. one.

Customer Service: 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Time; excluding holidays.
180
 Problem What It May Mean What To Do
You are not If you are using Disconnect headphones or
receiving peripherals such as peripherals when you are not
alarms. wireless headphones using them.
(cont.) or a smartwatch, you
may receive alarms
on only one device
or peripheral, not all.

You have closed the Make sure the App is always open
App. in the background.

Your device's battery Charge your device. If using the

is dead. Reader, use the included USB
cable.

Customer Service: 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Time; excluding holidays.
181
Blood Glucose Error Messages
Error
What It May Mean What To Do
Message

E-1 The temperature is

too hot or too cold
1. M ove the Reader and test
strips to a location where the
for the Reader to temperature is within the test
work correctly. strip operating range. (See
test strip instructions for use
for the appropriate range).
2. Wait for the Reader and test
strips to adjust to the new
temperature.
3. Repeat the test using a new
test strip.
4. If the error reappears, contact
Customer Service.

E-2 Reader error. 1. Turn off the Reader.

2. Repeat the test using a new
test strip.
3. If the error reappears, contact
Customer Service.

Customer Service: 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Time; excluding holidays.
182
 Error
What It May Mean What To Do
Message

E-3 Blood drop is too

small.
1. R eview the testing
instructions.
or 2. Repeat the test using a new
test strip.
Incorrect test 3. If the error reappears, contact
procedure. Customer Service.
or
There may be a
problem with the test
strip.

E-4 The blood glucose

level may be too high
1. R epeat the test using a new
test strip.
to be read by the 2. If the error reappears, contact
system. your health care professional
or immediately.
There may be a
problem with the test
strip.

Customer Service: 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Time; excluding holidays.
183
 Error
What It May Mean What To Do
Message

Blood was applied 1. R eview the testing

E-5 to the test strip too instructions.
soon. 2. Repeat the test using a new
test strip.
3. If the error reappears, contact
Customer Service.

The test strip may not 1. C heck that you are using
E-6 be compatible with the correct test strip for
the Reader. the Reader. (See test strip
instructions for use to verify
your strip is compatible with
the Reader).
2. Repeat the test using a test
strip for use with your Reader.
3. If the error reappears, contact
Customer Service.

Customer Service: 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Time; excluding holidays.
184
 Error
What It May Mean What To Do
Message

E-7 Test strip may be

damaged, used, or
1. C heck that you are using
the correct test strip for
the Reader does not the Reader. (See test strip
recognize it. instructions for use to verify
your strip is compatible with
the Reader).
2. Repeat the test using a test
strip for use with your Reader.
3. If the error reappears, contact
Customer Service.

E-9 Reader error. 1. Turn off the Reader.

2. Repeat the test using a new
test strip.
3. If the error reappears, contact
Customer Service.

Customer Service: 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Time; excluding holidays.
185
Problems Checking Your Blood Glucose
Problem What It May Mean What To Do

The Reader Test strip is not 1. With the 3 black lines facing
does not inserted correctly up, insert the test strip into
start a or not inserted fully the strip port until it stops.
test after into the strip port. 2. If the Reader still does not
inserting a start a test, contact Customer
test strip. Service.

Reader battery is too Charge the Reader.

low.

The test strip is Insert a new FreeStyle Precision

damaged, used, or Neo test strip.
unrecognizable by
the Reader.

Reader is outside Move the Reader to a

of its operating temperature between 50°F and
temperature range. 113°F and then try to power it
on.
Customer Service: 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Time; excluding holidays.
186
 Problem What It May Mean What To Do
The test Blood sample is too 1. S ee test strip instructions
does not small. for use for re-application
start after instructions.
applying 2. Repeat the test using a new
the blood test strip.
sample. 3. If the test still does not start,
contact Customer Service.

Sample applied after 1. R eview the testing

the Reader turned instructions.
off. 2. Repeat the test using a new
test strip.
3. If the test still does not start,
contact Customer Service.

Problem with 1. R epeat the test using a new

Reader or test strip. test strip.
2. If the test still does not start,
contact Customer Service.

Customer Service: 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Time; excluding holidays.
187
Perform a Reader Test
System Status OK If you think the Reader is not working properly, you
System Info
can check the Reader by performing a Reader Test.
Reader Test
Touch the Settings symbol from the Home
Screen, select System Status and then select
Reader Test.
Event Log

Note: The Reader Test will perform internal

diagnostics and will allow you to check that the
display, sounds, and touchscreen are working
properly.

Customer Service
Customer Service is available to answer any questions you may have about
your FreeStyle Libre 3 System. Customer Service is available at 1-855-632-
8658 7 Days a Week from 8AM to 8PM Eastern Time; excluding holidays.
A printed copy of the User's Manual is available upon request. The latest
version of the User's Manual is available at www.FreeStyleLibre.us/
support/overview.html

188
 System Specifications
See test strip and control solution instructions for use for additional
specifications.
Sensor Specifications

Sensor glucose assay

Amperometric electrochemical sensor
method

Sensor glucose reading

40 to 400 mg/dL
range

Sensor size 2.9 mm height and 21 mm diameter

Sensor weight 1 gram

Sensor power source One silver oxide battery

Sensor data Up to 14 days

189
 Up to 14 days (glucose readings stored
Sensor memory
every 5 minutes)

Sensor transmission range 33 feet (10 meters) unobstructed

Operating temperature 50°F to 113°F

Sensor Applicator storage

36°F to 82°F
temperature

Operating and storage

10-90%, non-condensing
relative humidity

IP27: Can withstand immersion into 3

Sensor water resistance feet (one meter) of water for up to 30
and ingress protection minutes. Protected against insertion of
objects > 12 mm diameter.

Operating and storage -1,250 ft (-381 meters) to 10,000 ft

altitude (3,048 meters)

2.402-2.480 GHz BLE; GFSK;

Radio Frequency
4.6 dBm EIRP
190
 Reader Specifications
Blood glucose assay
20 to 500 mg/dL
range

Reader size 95 mm x 60 mm x 16 mm

Reader weight 65 grams

Reader power source One lithium-ion rechargeable battery

Reader battery life 4 days of typical use

Reader memory 90 days of typical use

Reader operating
50°F to 113°F
temperature

Reader storage
-4°F to 140°F
temperature
191
Operating and storage
10-90%, non-condensing
relative humidity

Reader moisture
Keep dry
protection

Operating and storage -1,250 ft (-381 meters) to 10,000 ft

altitude (3,048 meters)

60 seconds (120 seconds when test

Reader display timeout
strip is inserted)

Near Field Communication (13.56 MHz

RFID); ASK Modulation; 124 dBuV/m;
Radio Frequency
1.5 inch communication range
2.402-2.480 GHz BLE; GFSK; 2dBm EIRP

Data port Micro USB

Minimum Computer System must only be used with

Requirements EN60950-1 rated computers

Mean use life 3 years of typical use

192
 The Reader has a mean use life of
Reader cleaning and 3 years, which is 156 cleaning and
disinfection disinfection cycles (1 cycle per week
for 3 years).

Abbott Diabetes Care PRT31887

Power Adapter Output: 5V, 550mA or 0.55A
Operating temperature: 50°F to 104°F

Abbott Diabetes Care PRT21373

USB Cable Length: 37 inches (94 cm)
Color: Yellow

Security Measures and Quality of Service

Security Measures:
The communication between the Receiver (App or Reader) and Sensor during an activation scan is
a short range Near Field Communication (NFC) method which makes it difficult to interfere with
or intercept during transmission. The communication between the Receiver and Sensor for glucose
data is a standard Bluetooth Low Energy (BLE) connection. Mutual authentication is performed
between the Receiver and Sensor during the pairing process using application certificates,
preventing unauthorized devices from connecting to the Sensor. The transmitted data is protected
by encryption. This prevents unauthorized devices from accessing the data if they are within range
and intercept the transmission. Under normal operation, the industry standard BLE protocols allow
for many users to be in the same vicinity. In the case where the connection is lost due to out-of-
range or interference, only the authenticated Receiver that is paired with the Sensor will be able to
193
reconnect and receive glucose data. For apps, only apps logged into the same LibreView account
that activated the Sensor are able to complete pairing with the Sensor. For Readers, only the
Reader that activated the Sensor is able to complete pairing with the Sensor.
Quality of Service (QoS):
QoS for the FreeStyle Libre 3 Reader and Sensor wireless communications using NFC (for Sensor
activation) is assured when the Reader is brought near the Sensor. The communication for activation
is specified to occur within 15 seconds.
QoS for the Reader and Sensor wireless communications using BLE for normal operation (receiving
glucose readings and alarms) is assured at regular 1-minute intervals. If connection is lost between
the Reader and Sensor for 5-minutes, the Reader will display an indication of "Signal Loss" on
the results screen. If connection is lost for 20 minutes, the Reader alarms the user if the alarm is
turned on. If connection is lost between the Reader and the Sensor, all lost glucose data will be
automatically retrieved when the connection is restored. The Reader is designed to only accept BLE
data from recognized and paired Sensors. The transmission range for BLE communication is 33 feet
unobstructed. If the Reader and Sensor are seeing frequent signal loss at longer distances, bring
them closer together.
QoS for the FreeStyle Libre 3 app and Sensor wireless communication using NFC (for Sensor
activation) is assured when the phone is touched to the Sensor. The communication for activation
takes place within 1 second. If the expected response is not received, the phone will continue to
retry.

194
 QoS for the FreeStyle Libre 3 app and Sensor wireless communications using BLE for normal
operation (receiving glucose reading and alarms) is assured at regular 1-minute intervals. If
connection is lost between the App and Sensor for 5-minutes, the App will display an indication of
“Signal Loss” on the Home Screen. If connection is lost for 20 minutes, the App alarms the user if
the alarm is turned on. If connection is lost between the Sensor and the App, all lost glucose data
will be automatically retrieved when the connection is restored. The App is designed to only accept
BLE data from recognized and paired Sensors. The transmission range for BLE communication is 33
feet unobstructed. If the phone and Sensor are seeing frequent signal loss at longer distances, bring
them closer together.

195
Labeling Symbols

Consult instructions for

Catalog number
use

Temperature limit Serial number

Manufacturer Keep dry

Batch code Non-ionizing radiation

Type BF applied part Caution

Sterilized using
Do not re-use
irradiation

MR unsafe Humidity limitation

FCC Declaration of
Use-by date
Contains FCC ID:
Conformity mark
N6C-SXSDCAG,
IC: 4908B-SXSDCAG
196
 Do not use if package is damaged.
For Sterile Barrier: Do not use if the product
sterile barrier system or its packaging is
compromised.

CAUTION: Federal law restricts this device to

sale by or on the order of a physician.

This product contains electronic equipment,

batteries, sharps and materials that may
contact bodily fluids during use. Dispose of
product in accordance with all applicable local
regulations.

Sterile Barrier. Refer to Instructions for Use if

opened or damaged.

Single sterile barrier system with protective

packaging outside

197
 Performance Characteristics
Overview of Clinical Studies
Three studies were conducted in the United States (US) to evaluate the performance, safety,
effectiveness, and precision of the FreeStyle Libre 3 Continuous Glucose Monitoring System (System).
One study included adults (Study 1), one study included pediatrics (Study 2) and one study included
both adults and pediatrics (Study 3).
All subjects required insulin to manage their diabetes. To measure the precision of the System, each
subject wore two Sensors, one on the back of each upper arm, for a period of up to 14 days. While in
the clinic, subjects had their venous blood glucose analyzed using a laboratory reference method, the
Yellow Springs Instrument Life Sciences 2300 STAT Plus™ Glucose & Lactate Analyzer (YSI). Sensor
glucose readings were then compared to the YSI glucose results in subjects 6 years and older to
evaluate the System’s performance. For subjects 4-5 years old, System performance was compared
against a self-monitoring blood glucose meter.
Study 1: Study 1 was conducted at 5 centers with 146 subjects in total (91.1% Type 1, 8.9% Type 2), all
aged eighteen and older. Subjects had their venous blood glucose analyzed over three separate visits to
the clinical center. Each visit lasted up to ten hours. 144 subjects were analyzed during the beginning
of the Sensor wear period (day 1, 2, or 3), 91 subjects were analyzed during the early middle period
(day 7 or 8), 55 subjects were analyzed during the late middle period (day 9 or 12), and 76 subjects
were analyzed during the end period (day 13 or 14). During each visit, adult subjects had their glucose
levels deliberately manipulated per the study protocol to raise or lower glucose. This was done to assess
performance of the System over the range that the System measures glucose (40 – 400 mg/dL).
Study 2: Study 2 was conducted at 4 centers with 139 subjects in total (98.6% Type 1, 1.4% Type 2),
all aged four to seventeen. Subjects age six and older had their venous blood glucose analyzed for up
to 16 hours over one or two separate visits to the clinical center. Each visit lasted up to eight hours.
198
 During each visit, subjects age 11 and older had their glucose levels deliberately manipulated per the
study protocol to raise or lower glucose. This was done to assess performance of the System over the
range that the System measures glucose (40 – 400 mg/dL). 48 subjects were analyzed during the
beginning of the Sensor wear period (day 1 or 2), 50 subjects were analyzed during the early middle
period (day 7 or 8), 51 subjects were analyzed during the late middle period (day 9 or 12), and 51
subjects were analyzed during the end period (day 13 or 14). All subjects tested their blood glucose
using fingerstick capillary samples at least four times during each day of the study.
Study 3: Study 3 was conducted at 4 centers with 100 adult and pediatric subjects in total (83.0 %
Type 1, 17.0% Type 2). 56 adult subjects were aged 18 and older, 39 pediatric subjects were aged
six to seventeen and 5 pediatric subjects were aged four to five. Subjects aged six and older had
their venous blood glucose analyzed for up to 16 hours over one or two separate visits to the clinical
center. Each visit lasted up to eight hours. 81 subjects were analyzed during the beginning of the
Sensor wear period (day 1, 2 or 3), 46 subjects were analyzed during the early middle period (day 7
or 8), 47 subjects were analyzed during the late middle period (day 9 or 12), and 34 subjects were
analyzed during the end period (day 13 or 14).
Accuracy
Accuracy of the System was measured by comparing paired System Glucose Measurement (CGM) and
YSI blood glucose values. The percentage of total System readings that were within 20 mg/dL for YSI
blood glucose values < 70 mg/dL or 20% of YSI for blood glucose values ≥ 70 mg/dL is displayed in
Table 1a. The Mean Absolute Relative Difference (MARD) gives an indication of the average percent
disagreement between the CGM and the reference. For example, in the Adult subject group, 92.9%
of the readings fell within 20 mg/dL of YSI blood glucose values < 70 mg/dL and within 20% of
YSI blood glucose values ≥ 70 mg/dL. The total number of data pairs considered in the analysis
was 23,503. In the Adult subject group, the Mean Absolute Relative Difference was 8.9% for the
comparison with YSI reference. In the Pediatric subject group, the Mean Absolute Relative Difference
was 9.4% for the comparison with YSI reference.
199
Table 1a: Overall Accuracy to YSI
Percent
Percent
Number of Percent Within
Within
Subject CGM- Number of Within ±20% /
±20% / MARD (%)
Group Reference Subjects ±20% / ±20 mg/dL
±20 mg/dL
Pairs ±20 mg/dL in first
on Day 1
12 hours

Adults 23503 200 92.9 87.5 81.4 8.9

Children
8614 168 91.1 85.4 81.6 9.4
(age 6-17)

Children
413 13 86.4 87.5 89.2 11.5
(age 4-5)*

* No YSI measurements were obtained for children ages 4-5; results displayed are from CGM-SMBG matched paired
measurements.
The accuracy of different CGM glucose ranges versus YSI reference was assessed by calculating the
percentage of System readings that were within 15%, 20%, and 40% for reference values
≥ 70 mg/dL, and within 15 mg/dL, 20 mg/dL, and 40 mg/dL for values < 70 mg/dL. For blood
glucose values < 70 mg/dL, the difference in mg/dL between the CGM and YSI blood glucose values
was calculated. For values ≥ 70 mg/dL, the relative difference (%) to the YSI blood glucose values
was calculated. The results categorized within CGM glucose ranges are presented in Tables 1b and
1c. The results categorized within YSI glucose ranges are presented in Tables 1d and 1e.

200
 Table 1b: Accuracy to YSI within CGM Glucose Ranges (Adult; n=200)
CGM Number
Percent Percent Percent Percent Percent Percent Mean
Glucose of CGM- MARD
Within Within Within Within Within Within bias
Level † Reference (%)
±15 mg/dL ±20 mg/dL ±40 mg/dL ±15% ±20% ±40% (mg/dL)
(mg/dL) Pairs

<54 543 84.7 92.6 99.4 -6.7 14.2

54-69 3124 88.7 93.7 99.0 -3.6 11.0

70-180 11128 79.8 88.8 99.3 -4.9 9.8

181-250 4112 90.9 96.0 99.9 -7.7 7.2

>250 4596 94.1 98.0 100.0 -5.9 6.0

†
System range is 40-400 mg/dL.
201
Table 1c: Accuracy to YSI within CGM Glucose Ranges (Pediatric*; n=168)
CGM Number
Percent Percent Percent Percent Percent Percent Mean
Glucose of CGM- MARD
Within Within Within Within Within Within bias
Level † Reference (%)
±15 mg/dL ±20 mg/dL ±40 mg/dL ±15% ±20% ±40% (mg/dL)
(mg/dL) Pairs

<54 153 68.6 75.8 95.4 -12.1 18.8

54-69 915 84.6 88.9 96.7 -5.6 12.6

70-180 4149 78.8 87.8 98.9 -4.9 10.1

181-250 1640 87.9 95.4 99.7 -7.1 7.7

>250 1757 92.7 97.8 99.8 -2.1 6.9

* Includes children 6-17 years of age. No YSI measurements were obtained for children 4-5 years of age.
†
System range is 40-400 mg/dL.
202
 Table 1d: Accuracy to YSI within YSI Glucose Ranges (Adult; n=200)
YSI Number
Percent Percent Percent Percent Percent Percent Mean
Glucose of CGM- MARD
Within Within Within Within Within Within bias
Level Reference (%)
±15 mg/dL ±20 mg/dL ±40 mg/dL ±15% ±20% ±40% (mg/dL)
(mg/dL) Pairs

<54 446 91.0 97.5 100.0 7.4 15.5

54-69 3111 94.5 98.5 100.0 1.4 10.3

70-180 10748 80.2 88.7 99.5 -4.5 9.7

181-250 4122 89.7 95.1 99.8 -7.3 7.5

>250 5076 91.3 96.1 99.7 -11.5 6.9

203
Table 1e: Accuracy to YSI within YSI Glucose Ranges (Pediatric*; n=168)
YSI Number
Percent Percent Percent Percent Percent Percent Mean
Glucose of CGM- MARD
Within Within Within Within Within Within bias
Level Reference (%)
±15 mg/dL ±20 mg/dL ±40 mg/dL ±15% ±20% ±40% (mg/dL)
(mg/dL) Pairs

<54 140 91.4 96.4 99.3 7.6 16.4

54-69 773 96.4 98.7 100.0 1.0 9.4

70-180 4168 76.7 85.7 98.3 -4.2 10.7

181-250 1559 86.8 92.9 99.1 -5.0 8.1

>250 1974 90.8 97.7 99.9 -9.9 7.4

* Includes children 6-17 years of age. No YSI measurements were obtained for children 4-5 years of age.
204
 Agreement with ‘LO’ and ‘HI’ CGM Reading against YSI Reference
The System reports glucose concentrations between 40 and 400 mg/dL. When the System
determines that glucose level is below 40 mg/dL, it will report as ‘LO’. When the System determines
that glucose level is above 400 mg/dL, it will report as ‘HI’. Tables 2a and 2b display the
concurrence between the CGM and YSI reference glucose when CGM reads ‘LO’. For example, in the
Adult subject group, when CGM reading was ‘LO’, YSI glucose values were less than 50 mg/dL 20.0%
of the time, less than 60 mg/dL 40.0% of the time, less than 70 mg/dL 40.0% of the time, less than
80 mg/dL 80.0% of the time, and equal to or above 80 mg/dL 20.0% of the time.
Table 2a: Concurrence Analysis with ‘LO’ CGM Reading (Adult; n=200)
CGM- YSI (mg/dL)
Reference N
Pairs <50 <60 <70 <80 ≥80

n 1 2 2 4 1 5

Cumulative % 20.0 40.0 40.0 80.0 20.0

Table 2b: Concurrence Analysis with ‘LO’ CGM Reading (Pediatric*; n=168)
CGM- YSI (mg/dL)
Reference N
Pairs <50 <60 <70 <80 ≥80

n 0 1 3 3 0 3

Cumulative % 0.0 33.3 100.0 100.0 0.0

* Includes children 6-17 years of age. No YSI measurements were obtained for children 4-5 years of age.
205
Tables 2c and 2d display the concurrence between the CGM and YSI reference glucose when CGM
reads ‘HI’. In the Adult subject group, when CGM reading was ‘HI’, YSI glucose values were above
350 mg/dL 97.6% of the time, above 300 mg/dL 100.0% of the time, above 250 mg/dL 100.0% of
the time, and less than or equal to 250 mg/dL 0.0% of the time.
Table 2c: Concurrence Analysis with ‘HI’ CGM Reading (Adult; n=200)
CGM- YSI (mg/dL)
Reference N
Pairs >350 >300 >250 ≤250

n 120 123 123 0 123

Cumulative % 97.6 100.0 100.0 0.0

Table 2d: Concurrence Analysis with ‘HI’ CGM Reading (Pediatric; n=168)
CGM- YSI (mg/dL)
Reference N
Pairs >350 >300 >250 ≤250

n 40 43 45 0 45

Cumulative % 88.9 95.6 100.0 0.0

* Includes children 6-17 years of age. No YSI measurements were obtained for children 4-5 years of age.

206
 Concurrence of System and Reference (CGM vs. YSI)
The percentage of concurring glucose values (CGM vs. YSI) in each glucose reference range is presented
for each CGM range in Tables 3a and 3b and for each YSI range in Tables 3c and 3d. For example, in
the Adult subject group, when the System glucose readings were within the 81 to 120 mg/dL range,
actual blood glucose values were between 40 and 60 mg/dL 0.2% of the time, between 61 and
80 mg/dL 9.2% of the time, between 81 and 120 mg/dL 71.1% of the time, between 121 and
160 mg/dL 19.1% of the time, between 161 and 200 mg/dL 1.0% of the time, and between 201 and
250 mg/dL 0.1% of the time.

207
Table 3a: Concurrence Analysis by CGM Glucose Level (Adult; n=200)
CGM Glucose YSI Glucose Level (mg/dL)
Level 121- 161- 201- 251- 301- 351- N
(mg/dL) <40 40-60 61-80 81-120 >400
160 200 250 300 350 400

<40† 20.0 20.0 40.0 20.0 . . . . . . . 5

40-60 0.4 52.0 43.7 3.8 . 0.1 . . . . . 1950

61-80 . 17.8 62.2 19.6 0.4 0.0 . . . . . 3317

81-120 . 0.2 9.2 70.5 19.4 0.7 0.1 . . . . 4147

121-160 . . 0.1 8.4 71.1 19.1 1.0 0.2 0.1 . . 3883

161-200 . . . . 10.4 66.4 22.1 1.0 0.2 . . 2806

201-250 . . . . . 8.6 67.8 22.0 1.5 0.1 . 2804

251-300 . . . . . 0.1 8.8 67.6 21.7 1.7 0.1 2469

301-350 . . . . . . 0.4 13.9 68.9 15.8 1.1 1580

351-400 . . . . . . . 0.5 27.8 62.9 8.8 547

>400† . . . . . . . . 2.4 63.4 34.1 123

†
Levels out of System dynamic range.
208
 Table 3b: Concurrence Analysis by CGM Glucose Level (Pediatric*; n=168)
CGM Glucose YSI Glucose Level (mg/dL)
Level 121- 161- 201- 251- 301- 351- N
(mg/dL) <40 40-60 61-80 81-120 >400
160 200 250 300 350 400

<40† . 33.3 66.7 . . . . . . . . 3

40-60 0.5 47.5 41.3 9.6 0.9 0.2 . . . . . 554

61-80 . 11.4 59.7 26.8 2.0 . . . . . . 1025

81-120 . 0.2 8.2 67.4 22.8 1.3 0.1 . . . . 1590

121-160 . . . 9.1 71.1 18.4 1.3 . . . . 1437

161-200 . . . 0.1 15.5 66.0 18.2 0.2 . . . 1094

201-250 . . . . 0.3 10.6 59.1 29.0 1.0 0.1 . 1157

251-300 . . . . . 0.1 13.6 63.8 21.3 1.2 . 933

301-350 . . . . . . 0.3 24.4 58.4 16.7 0.2 616

351-400 . . . . . 1.0 . 0.5 34.1 59.1 5.3 208

†
>400 . . . . . . . 4.4 6.7 33.3 55.6 45
* Includes children 6-17 years of age. No YSI measurements were obtained for children 4-5 years of age.
†
Levels out of System dynamic range.
209
Table 3c: Concurrence Analysis by YSI Glucose Level (Adult; n=200)
YSI Glucose CGM Glucose Level (mg/dL)
Level 121- 161- 201- 251- 301- 351- N
†
(mg/dL) <40 40-60 61-80 81-120 >400†
160 200 250 300 350 400

<40 12.5 87.5 . . . . . . . . . 8

40-60 0.1 62.9 36.6 0.4 . . . . . . . 1612

61-80 0.1 25.8 62.5 11.5 0.1 . . . . . . 3301

81-120 0.0 1.9 16.3 73.5 8.2 . . . . . . 3977

121-160 . . 0.3 20.8 71.4 7.5 . . . . . 3871

161-200 . 0.0 0.0 0.9 25.7 64.8 8.4 0.1 . . . 2876

201-250 . . . 0.1 1.4 22.2 68.2 7.8 0.2 . . 2787

251-300 . . . . 0.3 1.1 24.3 65.6 8.6 0.1 . 2543

301-350 . . . . 0.3 0.3 2.2 29.3 59.5 8.3 0.2 1830

351-400 . . . . . . 0.3 6.0 34.8 48.0 10.9 716

>400 . . . . . . . 1.8 16.4 43.6 38.2 110

†
Levels out of System dynamic range.
210
 Table 3d: Concurrence Analysis by YSI Glucose Level (Pediatric*; n=168)
YSI Glucose CGM Glucose Level (mg/dL)
Level 121- 161- 201- 251- 301- 351- N
†
(mg/dL) <40 40-60 61-80 81-120 >400†
160 200 250 300 350 400

<40 . 100.0 . . . . . . . . . 3

40-60 0.3 68.5 30.5 0.8 . . . . . . . 384

61-80 0.2 23.5 62.8 13.4 . . . . . . . 974

81-120 . 3.5 18.0 70.0 8.6 0.1 . . . . . 1532

121-160 . 0.3 1.3 22.9 64.6 10.7 0.2 . . . . 1583

161-200 . 0.1. . 1.8 23.4 63.7 10.8 0.1 . 0.2 . 1134

201-250 . . . 0.2 1.8 19.3 66.2 12.3 0.2 . . 1033

251-300 . . . . . 0.2 30.9 54.8 13.8 0.1 0.2 1085

301-350 . . . . . . 1.7 30.9 55.9 11.0 0.5 644

351-400 . . . . . . 0.4 4.3 40.7 48.6 5.9 253

>400 . . . . . . . . 2.7 29.7 67.6 37

* Includes children 6-17 years of age. No YSI measurements were obtained for children 4-5 years of age.
†
Levels out of System dynamic range.
211
Glucose Rate of Change Accuracy
The System’s glucose rate of change (ROC) accuracy, as assessed by concurrence analysis, is presented
in Tables 4a and 4b. For example, in the Adult subject group, when the Sensor glucose ROC indicated
that glucose was changing slowly downward (-1 to 0 mg/dL/min), actual glucose levels in the body
were falling quickly (<-2 mg/dL/min) 1.0% of the time, falling (-2 to -1 mg/dL/min) 7.7% of the
time, changing slowly downward (-1 to 0 mg/dL/min) 68.0% of the time, changing slowly upward
(0 to 1 mg/dL/min) 19.9% of the time, rising (1 to 2 mg/dL/min) 2.3% of the time, and were rising
quickly (>2 mg/dL/min) 1.0% of the time.
Table 4a: Concurrence Analysis by Glucose Rate of Change (Adult; n=200)
CGM YSI (mg/dL/min)
N
(mg/dL/min) <-2 [-2, -1) [-1, 0) [0, 1] (1, 2] >2
<-2 (i) 34.5 44.9 18.0 2.3 0.3 . 345

-2 to -1 (m) 6.9 46.6 41.2 4.0 0.8 0.5 1210

-1 to 0 (g) 1.0 7.7 68.0 19.9 2.3 1.0 11735

0 to 1 (g) 0.7 2.8 26.0 50.3 14.3 5.8 7270

1 to 2 (k) 0.2 1.7 7.7 32.7 38.0 19.8 1322

>2 (h) 0.1 0.4 3.1 14.9 33.2 48.4 941

212
 Table 4b: Concurrence Analysis by Glucose Rate of Change (Pediatric*; n=168)
CGM YSI (mg/dL/min)
N
(mg/dL/min) <-2 [-2, -1) [-1, 0) [0, 1] (1, 2] >2
<-2 (i) 41.7 44.3 10.9 3.1 . . 192

-2 to -1 (m) 10.5 50.3 33.1 5.0 0.4 0.7 543

-1 to 0 (g) 1.7 10.1 62.7 20.5 3.4 1.5 3481

0 to 1 (g) 1.1 4.5 24.6 49.0 13.4 7.5 2923

1 to 2 (k) 0.2 2.5 9.5 29.0 38.1 20.7 603

>2 (h) . 1.0 3.9 14.8 29.9 50.4 488

* Includes children 6-17 years of age. No YSI measurements were obtained for children 4-5 years of age.
Alarm Performance
The tables in this section show the accuracy of the System’s Low and High Glucose Alarms. The Alarm
Rate tells you how often the alarm is right or wrong. The Detection Rate tells you how often the
System is able to recognize and notify you about a low or high glucose event.
Low Glucose Alarm Performance
Tables 5a and 5b display the percentages for these parameters:

213
True Alarm Rate
Tells you: When you got a low glucose alarm, were you actually low?
Definition: Percentage of time the alarm issued and blood glucose was below the alarm level within
15 minutes before or after the alarm.
False Alarm Rate
Tells you: Did you get a low glucose alarm that you shouldn’t have?
Definition: Percentage of time the alarm issued and blood glucose was not below the alarm level
within 15 minutes before or after the alarm.
Detection Rate
Tells you: When you were low, did you get a low glucose alarm?
Definition: Percentage of time blood glucose was below the alarm level and the alarm issued within
15 minutes before or after the glucose event.
Missed Detection Rate
Tells you: When you were low, did you miss a low glucose alarm?
Definition: Percentage of time blood glucose was below the alarm level and the alarm didn’t issue
within 15 minutes before or after the glucose event.
For example, the Adult study found that for a Low Glucose alarm level set to 70 mg/dL:
84.3% of the time a low glucose alarm was received when blood glucose was indeed below the alarm
level but 15.7% of the time a low glucose alarm was received when blood glucose wasn’t actually
below the alarm level.
89.0% of the time blood glucose was below the alarm level and a low glucose alarm was
appropriately issued but 11.0% of the time the glucose event was missed and no alarm was issued.

214
 Table 5a: Low Glucose Alarm Performance (Adult; n=200)
Alarm Rate Detection Rate
Low Glucose
Alarm level
Correct Detection Missed Detection
(mg/dL) True Alarm Rate (%) False Alarm Rate (%)
Rate (%) Rate (%)

60 70.9 29.1 75.8 24.2

70 84.3 15.7 89.0 11.0
80 90.3 9.7 97.0 3.0
90 92.3 7.7 98.4 1.6

Table 5b: Low Glucose Alarm Performance (Pediatric*; n=168)

Alarm Rate Detection Rate
Low Glucose
Alarm level
True Alarm False Alarm Correct Detection Missed Detection
(mg/dL)
Rate (%) Rate(%) Rate (%) Rate (%)

60 60.5 39.5 86.8 13.2

70 77.1 22.9 92.8 7.2
80 82.3 17.7 96.2 3.8
90 90.0 10.0 97.5 2.5
* Includes children 6-17 years of age. No YSI measurements were obtained for children 4-5 years of age.
215
High Glucose Alarm Performance
Tables 5c and 5d display the percentages for these parameters:
True Alarm Rate
Tells you: When you got a high glucose alarm, were you actually high?
Definition: Percentage of time the alarm issued and blood glucose was above the alarm level within
15 minutes before or after the alarm.
False Alarm Rate
Tells you: Did you get a high glucose alarm that you shouldn’t have?
Definition: Percentage of time the alarm issued and blood glucose was not above the alarm level
within 15 minutes before or after the alarm.
Detection Rate
Tells you: When you were high, did you get a high glucose alarm?
Definition: Percentage of time blood glucose was above the alarm level and the alarm issued within
15 minutes before or after the glucose event.
Missed Detection Rate
Tells you: When you were high, did you miss a high glucose alarm?
Definition: Amount of time blood glucose was above the alarm level and the alarm didn’t issue
within 15 minutes before or after the glucose event.

216
 For example, the Adult study found that for a High Glucose alarm level set to 200 mg/dL:
98.7% of the time a high glucose alarm was received when blood glucose was indeed above the
alarm level but 1.3% of the time a high glucose alarm was received when blood glucose wasn’t
actually above the alarm level.
96.7% of the time blood glucose was above the alarm level and a high glucose alarm was
appropriately issued but 3.3% of the time the glucose event was missed and no alarm was issued.

Table 5c: High Glucose Alarm Performance (Adult; n=200)

Alarm Rate Detection Rate
High Glucose
Alarm level
True Alarm False Alarm Correct Detection Missed Detection
(mg/dL)
Rate (%) Rate (%) Rate (%) Rate (%)

120 99.0 1.0 98.0 2.0

140 98.7 1.3 97.5 2.5
180 98.7 1.3 96.8 3.2
200 98.7 1.3 96.7 3.3
220 98.3 1.7 96.7 3.3
240 98.0 2.0 95.5 4.5
300 96.2 3.8 90.2 9.8

217
Table 5d: High Glucose Alarm Performance (Pediatric*; n=168)
Alarm Rate Detection Rate
High Glucose
Alarm level
True Alarm Rate False Alarm Rate Correct Detection Missed Detection
(mg/dL)
(%) (%) Rate (%) Rate (%)

120 98.9 1.1 97.2 2.8

140 97.8 2.2 97.0 3.0
180 98.1 1.9 97.0 3.0
200 97.4 2.6 97.6 2.4
220 97.7 2.3 96.8 3.2
240 97.6 2.4 95.2 4.8
300 90.9 9.1 91.0 9.0
* Includes children 6-17 years of age. No YSI measurements were obtained for children 4-5 years of age.
Sensor Accuracy Over Time
The Sensor can be worn for up to 14 days. The percentage of System readings within YSI values and
the Mean Absolute Relative Difference (MARD) is presented for the following different wear periods
in Tables 6a and 6b: Beginning (Adult: 198 Subjects, Day 1, 2 or 3; Pediatric: 75 Subjects, Day 1,
2 or 3) Early Middle (Adult: 124 Subjects, Day 7 or 8; Pediatric: 63 Subjects, Day 7 or 8), Late Middle
(Adult: 86 Subjects, Day 9 or 12; Pediatric: 67 Subjects, Day 9 or 12), and End (Adult: 97 Subjects,
Day 13 or 14; Pediatric: 64 Subjects, Day 13 or 14). For values 70 mg/dL and above, the percentage
of readings within 15%, 20%, and 40% of the YSI value was calculated. For values below
70 mg/dL, the percentage of readings within 15 mg/dL, 20 mg/dL, and 40 mg/dL of the YSI value
was calculated.
218
 Table 6a: Sensor Accuracy Relative to YSI over the wear duration (Adult; n=200)
Number of
Wear Within ±15% / Within ±20% / Within ±40% /
CGM-reference MARD (%)
Period ±15 mg/dL ±20 mg/dL ±40 mg/dL
pairs

Beginning 8753 9.6 84.2 91.1 99.4

Early Middle 5540 8.4 88.2 94.7 99.8
Late Middle 4753 8.3 87.9 93.8 99.7
End 4457 8.8 86.8 93.2 99.9

Table 6b: Sensor Accuracy Relative to YSI over the wear duration (Pediatric*; n=168)
Number of
Wear Within ±15% / Within ±20% / Within ±40% /
CGM-reference MARD (%)
Period ±15 mg/dL ±20 mg/dL ±40 mg/dL
pairs

Beginning 2695 10.2 80.3 88.6 98.6

Early Middle 2031 9.0 85.5 90.9 98.4
Late Middle 1947 8.9 86.4 94.1 99.6
End 1941 9.5 84.1 91.7 99.4
* Includes children 6-17 years of age. No YSI measurements were obtained for children 4-5 years of age.

219
Sensor Wear Duration
The Sensor can be worn for up to 14 days. To estimate how long a Sensor will work over the wear
duration, 101 Sensors were evaluated to determine how many days of readings each Sensor
provided. Of the 101 Sensors, 68.3% lasted until the final day of use. 15 Sensors (14.9%) had “early
Sensor shut-off” where the Sensor algorithm detected that the Sensors did not function as intended
and presented the user with a Replace Sensor message. Table 7 displays the data for each day in the
wear duration for Study 3.
Because Study 3 was negatively affected by a software configuration unique to the investigational
device, a subsequent study was conducted in adults to assess the impact of the final software
configuration on "early Sensor shut-off" as well as to determine the survival rate after eliminating
for physical factors (for example, getting caught in car seat belt, accidental knocking off the Sensor,
etc.). A total of 34 of the 39 (87.2%) Sensors gave glucose results over the entire intended wear
period of 14 days. After accounting for these factors, the actual survival rate was 94.4%.

220
 Table 7: Sensor Survival Rate Over Wear Duration (n=101)
Day of Wear Number of Sensors Survival Rate (%)

1 99 98.0
2 99 98.0
3 99 98.0
4 98 97.0
5 96 95.0
6 96 95.0
7 93 92.1
8 92 91.1
9 90 89.1
10 85 84.2
11 79 78.2
12 73 72.3
13 70 69.3
14 69 68.3

221
Glucose Reading Availability
The System is designed to log a glucose reading every minute throughout the wear period after the
startup time. Table 8 shows the glucose reading capture rate for each day of the wear duration for
Study 3.
Table 8: Glucose Reading Capture Rate Over Wear Duration (n=101)
Day of Wear Number of Sensors Capture Rate (%)

1 101 99.8
2 99 99.9
3 99 99.8
4 99 99.8
5 98 99.9
6 96 99.7
7 96 100.0
8 93 99.9
9 92 99.9
10 90 99.9
11 85 99.5
12 80 99.8
13 73 99.7
14 70 100.0
222
 Precision
Precision of the System was evaluated by comparing the results from two separate Sensors worn on
the same subject at the same time. Table 9 provides data from 100 subjects in Study 3. For adults,
the paired absolute relative difference (PARD) between the two Sensors was 5.9% with coefficient
of variation (CV) of 4.2%. For children ages 4-5, PARD was 4.7% with CV of 3.3%. For children
ages 6-17, PARD was 8.1% with CV of 5.7%. Paired absolute difference (PAD) is a measurement of
absolute difference (in mg/dL) between paired CGM readings, while PARD is the absolute relative
difference (in %) between paired CGM readings.
Table 9: Overall between Sensor Precision (n=100)
Paired Absolute
Coefficient of Paired Absolute Number of Paired
Subject Group Relative Difference
Variation (%) Difference (mg/dL) Readings
(%)

Adults ages 18+ 4.2 9.1 5.9 156942

Children ages
4-5
3.3 9.3 4.7 14190
Children ages
6-17
5.7 12.8 8.1 103741

223
Study 3
The purpose of Study 3 was to assess the performance of the system with a smaller form factor
Sensor, which is the final FreeStyle Libre 3 configuration. Accuracy of the System was measured
by comparing paired System Glucose Measurement (CGM) and YSI blood glucose values. The
percentage of total system readings that were within 20 mg/dL for YSI blood glucose value
< 70 mg/dL or 20% of YSI for blood glucose values ≥ 70 mg/dL is displayed in Table 10. The Mean
Absolute Relative Difference (MARD) gives an indication of the average percent disagreement
between the CGM and the reference. For example, 93.2% of the readings fell within
+/- 20 mg/dL of YSI blood glucose values < 70 mg/dL and within +/- 20% of YSI blood glucose
values ≥ 70 mg/dL. The total number of data pairs considered in the analysis was 6836. In this
study the Mean Absolute Relative Difference was 7.9% for the comparison with the YSI reference.
Table 10: Overall Accuracy to YSI
Number of Percent
Number of
Subject Group CGM-Reference Within ±20% / MARD (%)
Subjects
Pairs ±20 mg/dL

Overall 95 6836 93.2 7.9

Adults 56 4768 94.7 7.6

Children ages
6-17
39 2068 89.7 8.7
Children ages
4-5*
5 72 88.9 10.1

* No YSI measurements were obtained for children ages 4-5; results displayed are from CGM-SMBG matched
paired measurements.
224
 Adverse Events
No device related serious adverse events occurred during the studies. In Study 1, mild skin
irritations, such as erythema, bruising, bleeding, and scabbing were reported around the insertion
site and adhesive area by a small number of subjects (10 out of 146 or 6.8%). Pain was mostly
reported as none with only one instance of mild pain. In Study 2, there were 8 instances of
erythema (4 “well-defined redness”, and 4 “slight pink”), 5 instances of edema (3 slight edema, 2
slight edema with defined edges), 2 instances of mild bleeding, one instance of mild induration and
one instance of mild rash. In Study 3, there were 5 instances of erythema (3 “well-defined redness”,
and 2 “slight pink”), 4 instances of mild or moderate bleeding, 2 instances of mild induration, one
instance of edema (“slight”) and one instance of mild itching.
Ascorbic Acid Interference
Taking ascorbic acid (vitamin C) supplements while wearing the Sensor may falsely raise Sensor
glucose readings. Taking more than 500 mg of ascorbic acid per day may affect the Sensor
readings which could cause you to miss a severe low glucose event. Ascorbic acid can be found
in supplements including multivitamins. Some supplements, including cold remedies such as
Airborne® and Emergen-C®, may contain high doses of 1000 mg of ascorbic acid and should not be
taken while using the Sensor. See your health care professional to understand how long ascorbic
acid is active in your body.

225
Additional notes for Health Care Professionals
A clinical study was conducted to evaluate the effect of ascorbic acid on Sensor performance. Data
from 57 adult subjects with diabetes was collected over a 13-hour period. Each subject had a one-
hour baseline phase where venous blood was collected every 10 minutes. After this first hour, a
dose of 1000 mg ascorbic acid was given with a meal and venous samples were collected every
20 minutes for the next four hours. A maximum average Sensor bias of 9.3 mg/dL was observed
around 3 hours after the 1000 mg ascorbic acid dose. Subjects then received a second dose of
1000 mg ascorbic acid with a meal and the same process was continued for another 4 hours. A third
dose of 1000 mg ascorbic acid was then given and study subjects were followed for 4 more hours.
After the second dose of ascorbic acid the maximum average Sensor bias increased, with minimal
change in Sensor bias after the third dose, suggesting that saturation had occurred by the second
1000 mg dose of ascorbic acid. The maximum average Sensor bias after the three 1000 mg doses of
ascorbic acid was less than 20 mg/dL.

226
 Electromagnetic Compatibility (EMC)
FreeStyle Libre 3 Reader - FCC ID: QXS-LIB02
FreeStyle Libre 3 Sensor - FCC ID: QXS-LIB03S
• The System needs special precautions regarding EMC and needs to be installed and put into service
according to the EMC information provided in this manual.
• Portable and mobile RF communications equipment can affect the System.
• Use of accessories, transducers, and cables other than those specified or provided by Abbott
Diabetes Care could result in increased electromagnetic emissions or decreased electromagnetic
immunity of the System and result in improper operation.
• The System should not be used adjacent to or stacked with other equipment and that if adjacent
or stacked use is necessary, the System should be observed to verify normal operation in the
configuration in which it will be used.
• The device complies with part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) The device may not cause harmful interference, and (2) the device must accept any
interference received, including interference that may cause undesired operation.
• Changes or modifications not approved by Abbott could void the user’s authority to operate the
equipment.

227
Guidance and manufacturer’s declaration –
electromagnetic emissions
The System is intended for use in the electromagnetic environment specified below. The customer or
the user of the System should assure that it is used in such an environment.
Electromagnetic
Emissions test Compliance
environment – guidance
RF emissions Group 1 The System uses RF energy
CISPR 11 only for its internal function.
Therefore, its RF emissions
are very low and are not likely
to cause any interference in
nearby electronic equipment.

RF emissions Class B The System is suitable for use

CISPR 11 in all establishments, including
domestic establishments and
Harmonic emissions Class A
those directly connected to
IEC 61000-3-2
the public low voltage power
Voltage fluctuations / Complies supply network that supplies
flicker emissions buildings used for domestic
IEC 61000-3-3 purposes.

228
 Guidance and manufacturer’s declaration –
electromagnetic immunity
The System is intended for use in the electromagnetic environment specified below. The customer or
the user of the System should assure that it is used in such an environment.
Immunity IEC 60601 Compliance Electromagnetic
test test level Level environment – guidance
Electrostatic ± 8 kV contact ± 8 kV contact Floors should be wood, concrete or
discharge (ESD) ± 15 kV air ± 15 kV air ceramic tile. If floors are covered
IEC 61000-4-2 with synthetic material, the relative
humidity should be at least 30%.

Electrical fast ± 2 kV for ± 2 kV for Mains power quality should be that

transient/burst power supply power supply of a typical domestic, commercial,
IEC 61000-4-4 lines (100kHz lines (100kHz or hospital environment.
frequency) frequency)
± 1 kV for signal ± 1 kV for signal
lines (100kHz lines (100kHz
frequency) frequency)

229
 Immunity IEC 60601 Compliance Electromagnetic
test test level Level environment – guidance
Surge ±1 kV ±1 kV Mains power quality should be that
IEC 61000-4-5 differential differential of a typical domestic, commercial,
mode mode or hospital environment.
±2 kV common ±2 kV common
mode mode

Voltage 0% UT; 0.5 cycle 0% UT; 0.5 cycle Mains power quality should be that
dips, short At 0⁰, 45⁰, 90⁰, At 0⁰, 45⁰, 90⁰, of a typical domestic, commercial,
interruptions and 135⁰, 180⁰, 225⁰, 135⁰, 180⁰, 225⁰, or hospital environment. If the user
voltage variations 270⁰ and 315⁰ 270⁰ and 315⁰ of the System requires continued
on power supply 0% UT; 1 cycle 0% UT; 1 cycle operation during power mains
input lines and and interruptions, it is recommended
IEC 61000-4-11 70% UT; 70% UT; that the System be powered from
25/30 cycles 25/30 cycles an uninterruptible power supply or
Single phase: Single phase: a battery.
at 0⁰ at 0⁰
0% UT; 0% UT;
250/300 cycle 250/300 cycle

230
 Immunity IEC 60601 Compliance Electromagnetic
test test level Level environment – guidance
Power frequency 30 A/m 30 A/m Power frequency magnetic fields
(50/60 Hz) should be at levels characteristic
magnetic field of a typical location in a typical
IEC 61000-4-8 domestic, commercial, or hospital
environment.

Magnetic; IEC 30 A/m 30 A/m Power frequency magnetic fields

61000-4-8 should be at levels characteristic
of a typical location in a typical
domestic, commercial, or hospital
environment.

NOTE UT is the a.c. mains voltage prior to application of the test level

231
 IMMUNITY IEC 60601 Compliance Electromagnetic
test test level Level environment – guidance
Conducted RF 6 Vrms 6 Vrms Portable RF communications
IEC 61000-4-6 150 kHz to equipment (including peripherals
80 MHz such as antenna cables and
external antennas) should be used
no closer than 30 cm (12 inches) to
any part of the System, including
Radiated RF 10 V/m 10 V/m cables specified by Abbott Diabetes
IEC 61000-4-3 80 MHz to Care. Otherwise degradation of the
performance of the System could
2.7 GHz result.

Proximity fields See table on next Compliance to the

from RF wireless page tested levels
communications
equipment
IEC 61000-4-3

232
 The table below lists the immunity levels at specific test frequencies for testing the effects of
some wireless communications equipment. The frequencies and services listed in the table are
representative examples in various locations where the System may be used.

Test Maximum IMMUNITY

Band a) Distance
frequency Service a) Modulation b) power TEST LEVEL
(MHz) (m)
(MHz) (W) (V/m)

Pulse
385 380 –390 TETRA 400 modulation b) 1.8 0.3 27
18 Hz

FM c)
GMRS 460, ± 5 kHz
450 430 – 470 2 0.3 28
FRS 460 deviation
1 kHz sine

710
Pulse
LTE Band 13,
745 704 – 787 modulation b) 0.2 0.3 9
17
217 Hz
780

810
GSM 800/900,
TETRA 800, Pulse
870 800 – 960 iDEN 820, modulation b) 2 0.3 28
CDMA 850, 18 Hz
LTE Band 5
930

233
 Test Maximum IMMUNITY
Band a) Distance
frequency Service a) Modulation b) power TEST LEVEL
(MHz) (m)
(MHz) (W) (V/m)

1720
GSM 1800;
CDMA 1900;
Pulse
GSM 1900;
1845 1700 – 1990 modulation b) 2 0.3 28
DECT;
217 Hz
LTE Band 1, 3,
4, 25; UMTS
1970

Bluetooth,
WLAN, Pulse
2450 2400 – 2570 802.11 b/g/n, modulation b) 2 0.3 28
RFID 2450, 217 Hz
LTE Band 7

5240
Pulse
WLAN 802.11
5500 5100 – 5800 modulation b) 0.2 0.3 9
a/n
217 Hz
5785
a)
For some services, only the uplink frequencies are included.
b)
The carrier is modulated using a 50% duty cycle square wave signal.
c)
As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not represent actual modulation,
it would be worst case.
234
 Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,d should
be less than the compliance level in each frequency range.e
Interference may occur in the vicinity of equipment marked with the following symbol:

d
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in
the location in which the System is used exceeds the applicable RF compliance level above, the System
should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the System.
e
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

235
Font License
©2013 Abbott
Licensed under the Apache License, Version 2.0 (the “License”); you may not use this file except in compliance with
the License. You may obtain a copy of the License at: http://www.apache.org/licenses/LICENSE-2.0
Unless required by applicable law or agreed to in writing, software distributed under the License is distributed
on an “AS IS” BASIS, WITHOUT WARRANTIES OR CONDITIONS OF ANY KIND, either express or implied. See the
License for the specific language governing permissions and limitations under the License.
Open Source Components: Material Design Icons
Copyright ©2014, Austin Andrews (http://materialdesignicons.com/), with Reserved Font Name Material Design
Icons.
Copyright ©2014, Google (http://www.google.com/design/) uses the license at https://github.com/google/
material-design-icons/blob/master/LICENSE
This Font Software is licensed under the SIL Open Font License, Version 1.1.
This license is copied below, and is also available with a FAQ at: http://scripts.sil.org/OFL
SIL OPEN FONT LICENSE
Version 1.1 - 26 February 2007
PREAMBLE
The goals of the Open Font License (OFL) are to stimulate worldwide development of collaborative font projects,
to support the font creation efforts of academic and linguistic communities, and to provide a free and open
framework in which fonts may be shared and improved in partnership with others.
The OFL allows the licensed fonts to be used, studied, modified and redistributed freely as long as they are not sold
by themselves. The fonts, including any derivative works, can be bundled, embedded, redistributed and/or sold
with any software provided that any reserved names are not used by derivative works. The fonts and derivatives,
however, cannot be released under any other type of license. The requirement for fonts to remain under this
license does not apply to any document created using the fonts or their derivatives.

236
 DEFINITIONS
“Font Software” refers to the set of files released by the Copyright Holder(s) under this license and clearly marked
as such. This may include source files, build scripts and documentation.
“Reserved Font Name” refers to any names specified as such after the copyright statement(s).
“Original Version” refers to the collection of Font Software components as distributed by the Copyright Holder(s).
“Modified Version” refers to any derivative made by adding to, deleting, or substituting — in part or in
whole — any of the components of the Original Version, by changing formats or by porting the Font Software
to a new environment.
“Author” refers to any designer, engineer, programmer, technical writer or other person who contributed to the
Font Software.
PERMISSION & CONDITIONS
Permission is hereby granted, free of charge, to any person obtaining a copy of the Font Software, to use, study,
copy, merge, embed, modify, redistribute, and sell modified and unmodified copies of the Font Software, subject
to the following conditions:
1) Neither the Font Software nor any of its individual components, in Original or Modified Versions, may be sold
by itself.
2) Original or Modified Versions of the Font Software may be bundled, redistributed and/or sold with any
software, provided that each copy contains the above copyright notice and this license. These can be included
either as stand-alone text files, human-readable headers or in the appropriate machine-readable metadata
fields within text or binary files as long as those fields can be easily viewed by the user.
3) No Modified Version of the Font Software may use the Reserved Font Name(s) unless explicit written
permission is granted by the corresponding Copyright Holder. This restriction only applies to the primary font
name as presented to the users.

237
4) The name(s) of the Copyright Holder(s) or the Author(s) of the Font Software shall not be used to promote,
endorse or advertise any Modified Version, except to acknowledge the contribution(s) of the Copyright
Holder(s) and the Author(s) or with their explicit written permission.
5) The Font Software, modified or unmodified, in part or in whole, must be distributed entirely under this license,
and must not be distributed under any other license. The requirement for fonts to remain under this license
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TERMINATION
This license becomes null and void if any of the above conditions are not met.
DISCLAIMER
THE FONT SOFTWARE IS PROVIDED “AS IS”, WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING
BUT NOT LIMITED TO ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND
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INCIDENTAL, OR CONSEQUENTIAL DAMAGES, WHETHER IN AN ACTION OF CONTRACT, TORT OR OTHERWISE,
ARISING FROM, OUT OF THE USE OR INABILITY TO USE THE FONT SOFTWARE OR FROM OTHER DEALINGS IN THE
FONT SOFTWARE.

238
 Limited Warranty
We hope that you are happy with your FreeStyle Libre 3 System. Please refer to the
User’s Manual before using your System for the first time.
Abbott Diabetes Care (“Abbott”) warrants that the FreeStyle Libre 3 Reader
(“Reader”) shall be free from defects in material and workmanship for a period of
one (1) year from the date of manufacture or one (1) year from the original date
of purchase with proof of purchase (whichever is later). This Limited Warranty
is invalid if the Reader is modified, altered, damaged, misused or used other
than in accordance with the User’s Manual, applicable labeling, and/or inserts.
Abbott’s sole obligation is to replace the Reader, free of charge, with the same
or an alternative reader as determined by Abbott in its sole discretion. Your
replacement may be a different model or type. Abbott may require, as a condition
of obtaining limited warranty service, that you return the Reader postage prepaid,
with proof of purchase to an address specified by Abbott. The Limited Warranty
on the replacement Reader will expire on the date of the original Limited Warranty
expiration or 90 days after the shipment of a replacement Reader, whichever period
is longer. This Limited Warranty covers only the Reader, does not cover the sensor or
disposable accessories, extends only to the original purchaser, and is not assignable
or transferable.
TO THE EXTENT POSSIBLE UNDER LAW, THE FOREGOING ARE ABBOTT’S ONLY
WARRANTIES FOR THE READER AND STATE YOUR EXCLUSIVE REMEDY. ABBOTT
MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, AND ABBOTT EXCLUDES
AND DISCLAIMS ANY OTHER WARRANTIES INCLUDING, BUT NOT LIMITED TO,
IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR
PURPOSE. ABBOTT DOES NOT WARRANT THAT OPERATION OF THE READER WILL
BE UNINTERRUPTED OR ERROR FREE AND ABBOTT WILL NOT BE LIABLE FOR
ANY LOST PROFITS, LOST SAVINGS OR OTHER SPECIAL, PUNITIVE, INCIDENTAL
239
OR CONSEQUENTIAL DAMAGES RESULTING DIRECTLY OR INDIRECTLY FROM
PURCHASE, OPERATION OR USE OF THE READER OR FAILURE OF THE READER
TO PERFORM IN ACCORDANCE WITH SPECIFICATIONS. NO WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, IF ANY IS IMPLIED
FROM THE SALE OF THE READER DESPITE ABBOTT’S SPECIFIC DISCLAIMER OF SUCH
WARRANTIES, SHALL EXTEND FOR A LONGER DURATION THAN ONE YEAR FROM
THE ORIGINAL DATE OF PURCHASE OF THE READER.
This Limited Warranty and any dispute or claim arising out of or in connection with
it shall be governed by and construed in accordance with the laws of Delaware.
Some states do not allow limitations on how long an implied warranty lasts or
the exclusion or limitation of incidental or consequential damages, so the above
limitations or exclusions may not apply to you.
Your Rights Under State Law: This Limited Warranty gives you specific legal rights,
and you may also have other rights that vary from state to state.
The circular shape of the sensor housing, FreeStyle, Libre, and related brand marks
are marks of Abbott.
LIMITED WARRANTY SERVICES
For questions or warranty service, contact Customer Service at 1-855-632-8658.
Customer Service is available 7 Days a Week from 8AM to 8PM Eastern Time;
excluding holidays.

ABBOTT MAY MODIFY OR DISCONTINUE THIS PROGRAM AT ANY TIME

WITHOUT NOTICE.

240
 References:
1
“FDA Public Health Notification: Use of Fingerstick Devices on More than One
Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication”
(2010)
http://wayback.archive-it.org/7993/20170111013014/http:/www.fda.gov/
MedicalDevices/Safety/AlertsandNotices/ucm224025.htm
2
“CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses
Risk for Transmitting Bloodborne Pathogens” (2010)
www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html
3
American Diabetes Association, 2019. 2. Classification and Diagnosis of Diabetes:
Standards of Medical Care in Diabetes—2019. Diabetes Care, 42(Supplement 1),
pp.S13-S28

241
Distributed by:
Abbott Diabetes Care Inc.
1360 South Loop Road
Alameda, CA 94502 USA
Customer Service: 1-855-632-8658
7 Days a Week from 8AM to 8PM Eastern Time; excluding holidays.
www.FreeStyleLibre.com

The circular shape of the sensor housing, FreeStyle, Libre, and related brand marks are
marks of Abbott. Other trademarks are the property of their respective owners.
Patent: www.abbott.com/patents

Manufacturer

©2022-2023 Abbott ART41641-001 Rev. A 05/23