FULL INDICATIONS AND IMPORTANT SAFETY INFORMATION
FREESTYLE LIBRE 3 system

You can use the FreeStyle Libre 3 System with either the FreeStyle Libre 3 Sensor or the FreeStyle Libre 3 Plus Sensor. The Indications for Use, Contraindications, Interfering Substance information, and Performance Characteristics are different between the two Sensors. Please reference the labeling content that applies to your Sensor. Make sure you have a FreeStyle Libre 3 Plus Sensor if you plan to connect with a compatible automated insulin dosing (AID) system.

FreeStyle Libre 3 Sensor

• 14 day wear duration
• Can be used by children age 4 and older
• Cannot be used with automated insulin dosing (AID) systems
• Taking more than 500 mg of Vitamin C per day may affect Sensor readings, which could cause you to miss a severe low glucose event

FreeStyle Libre 3 Plus Sensor

• 15 day wear duration
• Can be used by children age 2 and older
• Can be used with compatible automated insulin dosing (AID) systems
• Taking more than 1000 mg of Vitamin C per day may falsely raise Sensor readings, which could cause you to miss a severe low glucose event. You can take up to 1000 mg of Vitamin C per day and can still use the Sensor readings to make treatment decisions.

ONLINE LABELING

The latest version of the User’s Manual, including performance data, can always be accessed at FreeStyle Libre 3 Support & Resources | FreeStyle Libre US You can also order a free printed copy from Customer Service: 1-855-632-8658, 7 Days a Week from 8AM to 8PM Eastern Time; excluding holidays.

INDICATION FOR USE

FreeStyle Libre 3 Sensor users:

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.

FreeStyle Libre 3 Plus Sensor users:

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 2 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, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.

COMPATIBLE DEVICES, APPS, AND SOFTWARE

For a list of compatible devices, apps, and software that can be used with your Sensor, please go to: FreeStyle Libre 3 Support & Resources | FreeStyle Libre US Use of the Sensor with devices, apps, and software that are not listed may cause inaccurate glucose readings.

FreeStyle Libre 3 app is only compatible with certain mobile devices and operating systems. Please check FreeStyle Libre 3 Support & Resources | FreeStyle Libre US 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

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.

Automated Insulin Dosing: The FreeStyle Libre 3 Sensor must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems.

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.

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 the Support Section 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.
• 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.
• 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.
  • iPhones: In the phone settings for the App under Notifications, keep Allow Critical Alerts ON
  • 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.
• 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.

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 under the age specified in the Indications for Use. The System is not cleared for use in people under this 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.

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.
• 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.

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.
• 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.
• 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.

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.
• 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 in the user manual 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 could go as warm as 117°F. The maximum surface temperature of the power adapter when charging could go as warm as 129°F. 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.

INTERFERING SUBSTANCES

FreeStyle Libre 3 Sensor users:

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.

FreeStyle Libre 3 Plus Sensor users:

Taking more than 1000 mg of Vitamin C per day may falsely raise your Sensor readings, which could cause you to miss a severe low glucose event. Vitamin C can be found in supplements including multivitamins and cold remedies such as Airborne^® and Emergen-C^®. See your health care professional to understand how long Vitamin C is active in your body

FULL INDICATIONS AND IMPORTANT SAFETY INFORMATION
FREESTYLE LIBRE 2 system

You can use the FreeStyle Libre 2 System with either the FreeStyle Libre 2 Sensor or the FreeStyle Libre 2 Plus Sensor. The Indications for Use, Contraindications, Interfering Substance information, and Performance Characteristics are different between the two Sensors. Please reference the labeling content that applies to your Sensor. Make sure you have a FreeStyle Libre 2 Plus Sensor if you plan to connect with a compatible automated insulin dosing (AID) system.

FreeStyle Libre 2 Sensor

• 14 day wear duration
• Can be used by children age 4 and older
• Cannot be used with automated insulin dosing (AID) systems
• Taking more than 500 mg of Vitamin C per day may affect Sensor readings, which could cause you to miss a severe low glucose event

FreeStyle Libre 2 Plus Sensor

• 15 day wear duration
• Can be used by children age 2 and older
• Can be used with compatible automated insulin dosing (AID) systems
• Taking more than 1000 mg of Vitamin C per day may falsely raise Sensor readings, which could cause you to miss a severe low glucose event. You can take up to 1000 mg of Vitamin C per day and can still use the Sensor readings to make treatment decisions

ONLINE LABELING

The latest version of the User’s Manual, including performance data, can always be accessed at FreeStyle Libre 2 Support & Resources | FreeStyle Libre US You can also order a free printed copy from Customer Service: 1-855-632-8658, 7 Days a Week from 8AM to 8PM Eastern Time; excluding holidays.

INDICATION FOR USE

FreeStyle Libre 2 Sensor users:

The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time 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.

FreeStyle Libre 2 Plus Sensor users:

The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 2 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, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.

COMPATIBLE DEVICES, APPS, AND SOFTWARE

For a list of compatible devices, apps, and software that can be used with your Sensor please go to: FreeStyle Libre 2 Support & Resources | FreeStyle Libre US Use of the Sensor with devices, apps, and software that are not listed may cause inaccurate glucose readings. FreeStyle Libre 2 app is only compatible with certain mobile devices and operating systems. Please check the Support section on www.FreeStyleLibre.com for more information about device compatibility before upgrading your phone or its operating system.

CONTRAINDICATIONS

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.

Automated Insulin Dosing: FreeStyle Libre 2 Sensors must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems.

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 2 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.

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 20 feet of you at all times. The transmission range is 20 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.
• Alarms you receive do not include your glucose reading so you must scan your Sensor to check your glucose.

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 2 app is compatible with your OS and your phone. The OS Compatibility Guide is available in the Help section of the App or the Support Section 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.
• 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. For example, if you use an iPhone and the iOS Screen Time feature, add the FreeStyle Libre 2 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 20 feet of you at all times. The transmission range is 20 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.
• Glucose alarms you receive do not include your glucose reading so you must scan your Sensor to check your glucose.
• The App will ask for phone permissions which are needed to receive alarms. Allow these permissions when requested.
• Check to make sure that you have the correct phone settings and permissions enabled. If your phone is not configured properly, you will not be able to use the App, so you will not receive alarms or be able to check your glucose.
  • iPhones are to be configured as follows:
    • In the phone settings, keep Bluetooth ON
    • In the phone settings for the App, allow the App to access Bluetooth
    • In the phone settings for the App under Notifications, keep Allow Critical Alerts ON
  • Android Phones are to be configured as follows:
    • In the phone settings, keep Bluetooth ON
    • In the phone settings for the App, keep Do Not Disturb access permission ON
    • In the phone settings for the App, keep Nearby Devices permission ON. This permission is required for Android 12 and above
• 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 Bluetooth, Critical Alerts, Do Not Disturb access permission, Bluetooth access, and Nearby Devices permission, follow the instructions in the App.
• For Android Users, you may need to add the FreeStyle Libre 2 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.

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 under the age specified in the Indications for Use. The System is not cleared for use in people under this 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.

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.
• You must scan the Sensor to get your real-time current glucose level as both the Reader and App will not provide this information without a scan.
• 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.
• 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.

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, Sensor Pack, or Sensor Applicator appear to be damaged or already opened due to risk of no results and/or infection.
• 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 2 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 2 app and FreeStyle Libre 2 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:

• The Sensor Pack and Sensor Applicator are packaged as a set (separately from the Reader) and have the same Sensor code. Check that the Sensor codes match before using your Sensor Pack and Sensor Applicator. Do not use Sensor Packs and Sensor Applicators with different Sensor codes together as this will result in incorrect glucose readings.
• 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.
• 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.

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 2 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.
• 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 in the user manual 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 could go as warm as 117°F. The maximum surface temperature of the power adapter when charging could go as warm as 129°F. 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.

INTERFERING SUBSTANCES

FreeStyle Libre 2 Sensor users:

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.

FreeStyle Libre 2 Plus Sensor users:

Taking more than 1000 mg of Vitamin C per day may falsely raise your Sensor readings, which could cause you to miss a severe low glucose event. Vitamin C can be found in supplements including multivitamins and cold remedies such as Airborne^® and Emergen-C^®. See your health care professional to understand how long Vitamin C is active in your body.

FULL INDICATIONS AND IMPORTANT SAFETY INFORMATION
LIBRE APP (For use with FREESTYLE LIBRE 3 SENSOR AND FREESTYLE LIBRE 3 PLUS SENSOR)

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

GET INFORMED

• Before using the App, please review the complete product instructions and safety information in the User's Manual and take a look at the Interactive Tutorial on our website www.FreeStyleLibre.com. Tips for Kids are there too if you need.
• Be safe and follow the instructions properly. Using the System incorrectly could cause you to miss a severe low or high glucose event and/or make a harmful treatment decision.
• You'll always find the latest version of the User's Manual, including performance data at www.FreeStyleLibre.com. If you need a free printed copy, just call Customer Service: 1-855-632-8658, 7 days a week from 8 a.m. to 8 p.m. Eastern Time; excluding holidays.
• Talk to your health care professional about how to 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.

COMPATIBLE SENSORS

You can use Libre app with the FreeStyle Libre 3 Sensor and the FreeStyle Libre 3 Plus Sensor (simply referred to as Libre 3 Sensor and Libre 3 Plus Sensor). Some of the information in this User's Manual and the performance characteristics vary between the Sensors. Please reference the labeling content that applies to your Sensor. Make sure you have a Libre 3 Plus Sensor if you plan to connect with a compatible automated insulin dosing (AID) system.

Libre 3 Sensor

• 14 day wear
• Can be used by people age 4 and older
• Do not use with automated insulin dosing (AID) systems
• Taking more than 500 mg of Vitamin C per day may affect Sensor readings. This could cause you to miss a severe low glucose event.

Libre 3 Plus Sensor

• 15 day wear
• Can be used by people age 2 and older
• Can be used with compatible automated insulin dosing (AID) systems
• Taking more than 1000 mg of Vitamin C per day may falsely raise Sensor readings. This could cause you to miss a severe low glucose event. You can take up to 1000 mg of Vitamin C per day and still use the Sensor readings to make treatment decisions.

INDICATION FOR USE

Libre 3 Sensor users:

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.

Libre 3 Plus Sensor users:

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 2 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, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.

CHECK COMPATIBILITY

• Libre app is only compatible with certain phones and operating systems. Always check the Phone and OS Compatibility Guide before upgrading your phone or its operating system. This Guide is available in the App's Help Menu and in the Support section on www.FreeStyleLibre.com.
• Authorized compatible products that you can use with your Sensor are also listed at www.FreeStyleLibre.com. Using your Sensor with products that are not on this list may cause inaccurate glucose readings. If you use a computer, you are responsible for keeping it secure and up to date, for example by using anti-virus software and installing system updates.

CONTRAINDICATIONS

Diathermy: Remove all parts of your System before high-frequency electrical heat (diathermy) treatment. The effect of diathermy on the System hasn’t been tested. The exposure may damage the Sensor, which could impact proper device function and cause inaccurate readings.

Automated Insulin Dosing (AID): The Libre 3 Sensor must not be used with AID systems, including closed loop and insulin suspend systems.

WARNINGS

• Don't ignore low or high glucose symptoms. Use your blood glucose meter to make treatment decisions when your Sensor readings don’t match your symptoms or expectations. Get medical attention when appropriate.
• Use your blood glucose meter to make treatment decisions when your Sensor reading doesn’t match how you feel, has no number, or you see the symbol during the first 12 hours of Sensor wear. You cannot use Sensor values to make treatment decisions during the first 12 hours.
• Choking hazard: The System has small parts that may be dangerous if swallowed.
• You must have access to a blood glucose monitoring system. One is not provided when you use the App.

CAUTIONS – OVERALL SYSTEM

What to know before using the System:

• Avoid infection by taking standard precautions for bloodborne pathogens.
• Don't share the App with another person to avoid confusing glucose information.
• The App doesn’t share data with your System’s Reader. 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.
• Make sure that your phone and Sensor Kits are kept in a safe place and under your control. This is important to help stop anyone from accessing or tampering with the System.

Who should not use the System:

• Don't use in people under the age in the Indications for Use. The System is not cleared for use under this age.
• Don't use if you are on dialysis or critically ill. The System hasn’t been evaluated in these groups. Sensor readings may be inaccurate.
• The System hasn’t been evaluated when used with other implanted medical devices, such as pacemakers.

When is Sensor glucose different from blood glucose:

• Glucose levels in interstitial fluid (what your Sensor measures) can be different from blood glucose levels (what your meter measures). You may notice this when your glucose is changing quickly. For example, after eating, taking insulin, or exercising.

CAUTIONS – APP USE

What to know about the App:

• Disable your phone’s automatic operating system (OS) updates. Before updating your phone’s OS or the App, check the Phone and OS Compatibility Guide to see if the App is compatible. This Guide is available in the App’s Help menu and also in the Support section on www.FreeStyleLibre.com. Check it regularly to make sure that your phone and OS remain compatible with the App.
• We may contact you if an App or OS update will make your previously compatible phone incompatible. Make sure that your LibreView account has your current email address to receive important information.
• After an OS update, open the App and check your device settings to make sure it's working properly. Some OS features may impact your ability to get alarms or glucose readings. For example, if you use the iPhone Screen Time feature, add Libre app to the list of Always Allowed apps to ensure that you receive alarms. Or, if you use an Android phone, don’t use the Android Digital Wellbeing app.
• If you restart your phone, open the App to make sure it’s working properly.
• During set up, the App asks for phone permissions. Please allow these. If your phone is not set up properly, you will not be able to use the App and will not get alarms, including the Urgent Low Glucose Alarm. Confirm your settings are as follows:
  • iPhone settings:
    • In the phone settings, keep Bluetooth ON
    • In the phone settings for the App, allow the App to access Bluetooth
    • In the phone settings for the App under Notifications, keep Critical Alerts ON
  • Android phone settings:
    • In the phone settings, keep Bluetooth ON
    • In the phone settings for the App, keep Do Not Disturb access permission ON
    • In the phone settings for the App, keep Nearby Devices permission ON (for Android 12 and above)

  Follow the instructions in the App to turn on these settings and permissions. If your phone is not configured correctly, you will see Alarms Unavailable on your screen.

  • Android users may need to add Libre app to the list of the apps that will not be restricted or put to sleep.
  • If you adjust the phone ringer volume (iPhone) or Media volume (Android) 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.

For you to receive alarms:

• Keep your phone charged and turned on.
• Don't force close the App. The App must be running in the background to get alarms.
• Always keep your phone within 33 feet of you, with no obstacles between you. The Sensor itself will not issue alarms! If you’re out of range, you may not get alarms. If you want to use the App's optional alarms, keep these turned on.
• Disconnect headphones or speakers from your phone when not in use. You may miss alarm sounds if you don’t.
• Remember that if you have accessories connected to your phone (like wireless headphones or a smartwatch), you may get alarms on only one device, not all.

Go to the Alarms section in the user manual to learn more about the App's alarms.

CAUTIONS – SENSOR USE

What to know before you apply the Sensor:

• The Sensor inserts just under your skin. You may have some bruising or bleeding.
• Clean your hands before handling the Sensor Kit contents. This will help prevent infection.
• Carefully follow the instructions to prepare the application site on the back of your upper arm. This will help your Sensor stay on for the full wear time and not fall off early. Wash the site using a plain soap. Then, dry and clean with an alcohol wipe. This removes any oily residue and helps the Sensor stick. Allow the site to air dry before applying the Sensor.
• Only apply the Sensor to the back of your upper arm. The Sensor may not work properly in other areas. Avoid scars, moles, stretch marks, and lumps. Choose an area that stays mostly flat (no bending or folding) during your day. Keep at least 1 inch away from insulin injection sites.
• Change sites between Sensors so your skin can recover.

What to know about wearing a Sensor:

• Your Sensor's product insert tells you how long you can wear your Sensor. Remember to always have your next Sensor on hand before your current one ends so you can keep getting your glucose readings.
• If your Sensor stops working and you don’t have another Sensor, use another method to check your glucose and make treatment decisions.
• The App can detect when the Sensor isn’t working properly. It will shut your Sensor off and tell you to replace it. This may happen if the Sensor gets knocked off your body, or if there’s a problem with it. Call us if you receive a Replace Sensor message before the end of your wear time. Customer Service: 1-855-632-8658. Available 7 days a week, 8 a.m. to 8 p.m. Eastern Time; excluding holidays.
• Some people 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. Contact your health care professional before continuing to use the System.
• Intense exercise may cause your Sensor to loosen due to sweat or Sensor movement. If the Sensor gets loose or its tip comes out of your skin, you may get no readings or unreliable low readings. Remove your Sensor and apply a new one.
• Don’t attempt to reinsert the old one! Call us if any Sensor gets loose or falls off before the end of your wear time. Customer Service: 1-855-632-8658. Available 7 days a week, 8 a.m. to 8 p.m. Eastern Time; excluding holidays. Don't 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 in your body, call your health care professional.

How to store the Sensor Kit:

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

When to remove the Sensor:

• If the Sensor is becoming loose or if its tip is coming out of your skin, you may get no readings. Or, you may get unreliable readings that don’t match how you feel. Check to make sure your Sensor is not loose. If it’s loose, remove it and apply a new one. Please call Customer Service.
• If you think your glucose readings are incorrect or don’t match how you feel, do a blood glucose test on your finger to check your glucose. If the problem continues, remove the Sensor and apply a new one. Call Customer Service: 1-855-632-8658. Available 7 days a week, 8 a.m. to 8 p.m. Eastern Time; excluding holidays.

When not to use the Sensor:

• Don't use if the Sensor Kit carton or Sensor Applicator look damaged or if tamper label indicates Sensor Applicator has already been opened. Infection may result.
• Don't use if Sensor Kit contents have expired.

Go to the Applying Your Sensor section in the user manual to learn how to prepare and apply your Sensor.

MRI safety information:

• You can safely have a 1.5T or 3T MRI exam while wearing your Sensor, under the conditions listed below. Injury may result if the conditions are not followed. Leave your phone and Reader outside of the exam room. Sensor readings may be inaccurate during the MRI, but System function returns fully back to normal after 1 hour.

SECURITY INFORMATION

• You are responsible for properly securing and managing your phone. If you suspect an adverse cybersecurity event related to the App, contact Customer Service.
• The App 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.
• Don't use the App on a jailbroken or rooted device. When used on a jailbroken or rooted device or in the case of a potential cybersecurity event, the App will stop without notification. This means you won't receive alarms and will need to use another method to check your glucose. Please contact Customer Service.
• Use of an unsupported mobile device or OS version may affect App security and functionality. You are responsible for the risks associated with the use of the App on an unsupported mobile device or OS version.
• The App should only be downloaded and/or updated through authorized distributors, including the App Store (iPhone) and Google Play Store (Android).

INTERFERING SUBSTANCES

Libre 3 Sensor

Taking Vitamin C supplements while wearing the Sensor may falsely raise Sensor glucose readings. Taking more than 500 mg of Vitamin C per day may affect the Sensor readings. This could cause you to miss a severe low glucose event. Vitamin C 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 Vitamin C. These should not be taken while using the Sensor. See your health care professional to understand how long Vitamin C is active in your body.

Libre 3 Plus Sensor

Taking more than 1000 mg of Vitamin C per day may falsely raise your Sensor readings. This could cause you to miss a severe low glucose event. Vitamin C can be found in supplements including multivitamins and cold remedies such as Airborne^® and Emergen-C^®. See your health care professional to understand how long Vitamin C is active in your body.

FULL INDICATIONS AND IMPORTANT SAFETY INFORMATION
LIBRE APP (For use with FREESTYLE LIBRE 2 SENSOR AND FREESTYLE LIBRE 2 PLUS SENSOR)

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

GET INFORMED

• Before using the App, please review the complete product instructions and safety information in the User's Manual and take a look at the Interactive Tutorial on our website www.FreeStyleLibre.com. Tips for Kids are there too if you need.
• Be safe and follow the instructions properly. Using the System incorrectly could cause you to miss a severe low or high glucose event and/or make a harmful treatment decision.
• You'll always find the latest version of the User's Manual, including performance data at www.FreeStyleLibre.com. If you need a free printed copy, just call Customer Service: 1-855-632-8658, 7 days a week from 8 a.m. to 8 p.m. Eastern Time; excluding holidays.
• Talk to your health care professional about how to 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.

COMPATIBLE SENSORS

You can use Libre app with the FreeStyle Libre 2 Sensor and the FreeStyle Libre 2 Plus Sensor (simply referred to as Libre 2 Sensor and Libre 2 Plus Sensor). Some of the information in the User's Manual and the performance characteristics vary between the Sensors. Please reference the labeling content that applies to your Sensor. Make sure you have a Libre 2 Plus Sensor if you plan to connect with a compatible automated insulin dosing (AID) system.

Libre 2 Sensor

• 14 day wear
• Can be used by people age 4 and older
• Do not use with automated insulin dosing (AID) systems
• Taking more than 500 mg of Vitamin C per day may affect Sensor readings. This could cause you to miss a severe low glucose event.

Libre 2 Plus Sensor

• 15 day wear
• Can be used by people age 2 and older
• Can be used with compatible automated insulin dosing (AID) systems
• Taking more than 1000 mg of Vitamin C per day may falsely raise Sensor readings. This could cause you to miss a severe low glucose event. You can take up to 1000 mg of Vitamin C per day and still use the Sensor readings to make treatment decisions.

INDICATIONS FOR USE

Libre 2 Sensor users:

The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time 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.

Libre 2 Plus Sensor users:

The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 2 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, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.

CHECK COMPATIBILITY

• Libre app is only compatible with certain phones and operating systems. Always check the Phone and OS Compatibility Guide before upgrading your phone or its operating system. This Guide is available in the App's Help Menu and in the Support section on www.FreeStyleLibre.com.
• Authorized compatible products that you can use with your Sensor are also listed at www.FreeStyleLibre.com. Using your Sensor with products that are not on this list may cause inaccurate glucose readings. If you use a computer, you are responsible for keeping it secure and up to date, for example by using anti-virus software and installing system updates.

CONTRAINDICATIONS

Diathermy: Remove all parts of your System before high-frequency electrical heat (diathermy) treatment. The effect of diathermy on the System hasn’t been tested. The exposure may damage the Sensor, which could impact proper device function and cause inaccurate readings.

Automated Insulin Dosing (AID): The Libre 2 Sensor must not be used with AID systems, including closed loop and insulin suspend systems.

WARNINGS

• Don't ignore low or high glucose symptoms. Use your blood glucose meter to make treatment decisions when your Sensor readings don’t match your symptoms or expectations. Get medical attention when appropriate.
• Use your blood glucose meter to make treatment decisions when your Sensor reading doesn’t match how you feel, has no number, or you see the symbol during the first 12 hours of Sensor wear. You cannot use Sensor values to make treatment decisions during the first 12 hours.
• Choking hazard: The System has small parts that may be dangerous if swallowed.
• You must have access to a blood glucose monitoring system. One is not provided when you use the App.

CAUTIONS – OVERALL SYSTEM

What to know before using the System:

• Avoid infection by taking standard precautions for bloodborne pathogens.
• Don't share the App with another person to avoid confusing glucose information.
• The App doesn’t share data with your System’s Reader. 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.
• Make sure that your phone and Sensor Kits are kept in a safe place and under your control. This is important to help stop anyone from accessing or tampering with the System.

Who should not use the System:

• Don't use in people under the age in the Indications for Use. The System is not cleared for use under this age.
• Don't use if you are on dialysis or critically ill. The System hasn’t been evaluated in these groups. Sensor readings may be inaccurate.
• The System hasn’t been evaluated when used with other implanted medical devices, such as pacemakers.

When is Sensor glucose different from blood glucose:

• Glucose levels in interstitial fluid (what your Sensor measures) can be different from blood glucose levels (what your meter measures). You may notice this when your glucose is changing quickly. For example, after eating, taking insulin, or exercising.

CAUTIONS – APP USE

What to know about the App:

• Disable your phone’s automatic operating system (OS) updates. Before updating your phone’s OS or the App, check the Phone and OS Compatibility Guide to see if the App is compatible. This Guide is available in the App’s Help menu and also in the Support section on www.FreeStyleLibre.com. Check it regularly to make sure that your phone and OS remain compatible with the App.
• We may contact you if an App or OS update will make your previously compatible phone incompatible. Make sure that your LibreView account has your current email address to receive important information.
• After an OS update, open the App and check your device settings to make sure it's working properly. Some OS features may impact your ability to get alarms or glucose readings. For example, if you use the iPhone Screen Time feature, add Libre app to the list of Always Allowed apps to ensure that you receive alarms. Or, if you use an Android phone, don’t use the Android Digital Wellbeing app.
• If you restart your phone, open the App to make sure it’s working properly.
• During set up, the App asks for phone permissions. Please allow these. If your phone is not set up properly, you will not be able to use the App and will not get alarms, including the Urgent Low Glucose Alarm. Confirm your settings are as follows:
  • iPhone settings:
    • In the phone settings, keep Bluetooth ON
    • In the phone settings for the App, allow the App to access Bluetooth
    • In the phone settings for the App under Notifications, keep Critical Alerts ON
  • Android phone settings:
    • In the phone settings, keep Bluetooth ON
    • In the phone settings for the App, keep Do Not Disturb access permission ON
    • In the phone settings for the App, keep Nearby Devices permission ON (for Android 12 and above)

  Follow the instructions in the App to turn on these settings and permissions. If your phone is not configured correctly, you will see Alarms Unavailable on your screen.

  • Android users may need to add Libre app to the list of the apps that will not be restricted or put to sleep.
  • If you adjust the phone ringer volume (iPhone) or Media volume (Android) 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.

For you to receive alarms:

• Keep your phone charged and turned on.
• Don't force close the App. The App must be running in the background to get alarms.
• Always keep your phone within 20 feet of you, with no obstacles between you. The Sensor itself will not issue alarms! If you’re out of range, you may not get alarms. If you want to use the App's optional alarms, keep these turned on.
• Disconnect headphones or speakers from your phone when not in use. You may miss alarm sounds if you don’t.
• Remember that if you have accessories connected to your phone (like wireless headphones or a smartwatch), you may get alarms on only one device, not all.

Go to the Alarms section in the user manual to learn more about the App's alarms.

CAUTION – SENSOR USE

What to know before you apply the Sensor:

• Your Sensor Pack and Sensor Applicator come as a set with the same Sensor code. Check that the Sensor codes match! Don’t use Sensor Packs and Sensor Applicators with different Sensor codes together as you'll get incorrect glucose readings.
• The Sensor inserts just under your skin. You may have some bruising or bleeding. Clean your hands before handling the Sensor Kit contents. This will help prevent infection.
• Carefully follow the instructions to prepare the application site on the back of your upper arm. This will help your Sensor stay on for the full wear time and not fall off early. Wash the site using a plain soap. Then, dry and clean with an alcohol wipe. This removes any oily residue and helps the Sensor stick. Allow the site to air dry before applying the Sensor.
• Only apply the Sensor to the back of your upper arm. The Sensor may not work properly in other areas. Avoid scars, moles, stretch marks, and lumps. Choose an area that stays mostly flat (no bending or folding) during your day. Keep at least 1 inch away from insulin injection sites.
• Change sites between Sensors so your skin can recover.

What to know about wearing a Sensor:

• Your Sensor's product insert tells you how long you can wear your Sensor. Remember to always have your next Sensor on hand before your current one ends so you can keep getting your glucose readings.
• If your Sensor stops working and you don’t have another Sensor, use another method to check your glucose and make treatment decisions.
• The App can detect when the Sensor isn’t working properly. It will shut your Sensor off and tell you to replace it. This may happen if the Sensor gets knocked off your body, or if there’s a problem with it. Call us if you receive a Replace Sensor message before the end of your wear time. Customer Service: 1-855-632-8658. Available 7 days a week, 8 a.m. to 8 p.m. Eastern Time; excluding holidays.
• Some people 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. Contact your health care professional before continuing to use the System.
• Intense exercise may cause your Sensor to loosen due to sweat or Sensor movement. If the Sensor gets loose or its tip comes out of your skin, you may get no readings or unreliable low readings. Remove your Sensor and apply a new one. Don’t attempt to reinsert the old one! Call us if any Sensor gets loose or falls off before the end of your wear time. Customer Service: 1-855-632-8658. Available 7 days a week, 8 a.m. to 8 p.m. Eastern Time; excluding holidays.
• Don't 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 in your body, call your health care professional.

How to store the Sensor Kit:

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

When to remove the Sensor:

• If the Sensor is becoming loose or if its tip is coming out of your skin, you may get no readings. Or, you may get unreliable readings that don’t match how you feel. Check to make sure your Sensor is not loose. If it’s loose, remove it and apply a new one. Please call Customer Service.
• If you think your glucose readings are incorrect or don’t match how you feel, do a blood glucose test on your finger to check your glucose. If the problem continues, remove the Sensor and apply a new one. Call Customer Service: 1-855-632-8658. Available 7 days a week, 8 a.m. to 8 p.m. Eastern Time; excluding holidays.

When not to use the Sensor:

• Don't use if the Sensor Kit carton, Sensor Pack, or Sensor Applicator look damaged or opened. Infection may result.
• Don't use if Sensor Kit contents have expired.

Go to the Applying Your Sensor section in the user manual to learn how to prepare and apply your Sensor.

MRI safety information:

• You can safely have a 1.5T or 3T MRI exam while wearing your Sensor, under the conditions listed below. Injury may result if the conditions are not followed. Leave your phone and Reader outside of the exam room. Sensor readings may be inaccurate during the MRI, but System function returns fully back to normal after 1 hour.

SECURITY INFORMATION

• You are responsible for properly securing and managing your phone. If you suspect an adverse cybersecurity event related to the App, contact Customer Service.
• The App 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.
• Don't use the App on a jailbroken or rooted device. When used on a jailbroken or rooted device or in the case of a potential cybersecurity event, the App will stop without notification. This means you won't receive alarms and will need to use another method to check your glucose. Please contact Customer Service.
• Use of an unsupported mobile device or OS version may affect App security and functionality. You are responsible for the risks associated with the use of the App on an unsupported mobile device or OS version.
• The App should only be downloaded and/or updated through authorized distributors, including the App Store (iPhone) and Google Play Store (Android).

INTERFERING SUBSTANCES

Libre 2 Sensor

Taking Vitamin C supplements while wearing the Sensor may falsely raise Sensor glucose readings. Taking more than 500 mg of Vitamin C per day may affect the Sensor readings. This could cause you to miss a severe low glucose event. Vitamin C 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 Vitamin C. These should not be taken while using the Sensor. See your health care professional to understand how long Vitamin C is active in your body.

Libre 2 Plus Sensor

Taking more than 1000 mg of Vitamin C per day may falsely raise your Sensor readings. This could cause you to miss a severe low glucose event. Vitamin C can be found in supplements including multivitamins and cold remedies such as Airborne^® and Emergen-C^®. See your health care professional to understand how long Vitamin C is active in your body.

FULL INDICATIONS AND IMPORTANT SAFETY INFORMATION
FREESTYLE LIBRE 14 Day system

ONLINE LABELING

The latest version of the User’s Manual, including performance data, can always be accessed at FreeStyle Libre 14 Day Support & Resources | FreeStyle Libre US You can also order a free printed copy from Customer Service: 1-855-632-8658, 7 Days a Week from 8AM to 8PM Eastern Time; excluding holidays.

INDICATION FOR USE

The FreeStyle Libre 14 day Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device indicated for the management of diabetes in persons age 18 and older. It is designed to replace blood glucose testing for diabetes treatment decisions.

The System detects trends and tracks patterns aiding 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 intended for single patient use and requires a prescription.

CONTRAINDICATIONS

MRI/CT/Diathermy: The FreeStyle Libre 14 day Flash Glucose Monitoring 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.
• Check Sensor glucose readings by conducting a fingerstick test with a blood glucose meter under the following conditions, when Sensor glucose readings may not be accurate and should not be used to make a diabetes treatment decision:
  • If you suspect that your reading may be inaccurate for any reason
  • When you are experiencing symptoms that may be due to low or high blood glucose
  • When you are experiencing symptoms that do not match the Sensor glucose readings
  • During the first 12 hours of wearing a FreeStyle Libre 14 day Sensor
  • During times of rapidly changing glucose (more than 2 mg/dL per minute)
  • When the Sensor glucose reading does not include a Current Glucose number or Glucose Trend Arrow
  • In order to confirm hypoglycemia or impending hypoglycemia as reported by the Sensor
• When you see the symbol, you must check your blood glucose with a blood glucose meter before making any treatment decisions. Sensor readings may not accurately reflect blood glucose levels.
• Hypoglycemic unawareness: The System has not been evaluated for use in patients with hypoglycemic unawareness and will not automatically alert you of a hypoglycemic event without you scanning your Sensor.
• No alarms without a Sensor scan: The System does not have alarms that will automatically notify you when you are having a severe low (hypoglycemic) or high (hyperglycemic) glucose event unless you scan your Sensor. For example, the System does not have an alarm that can alert or wake you when you are sleeping in the case of low or high glucose.
• Choking hazard: The System contains small parts that may be dangerous if swallowed.

CAUTIONS AND LIMITATIONS

Below 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 Alarms/Alerts:

• There are NO alarms or alerts unless you scan the Sensor.

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.

Who should not use the System:

• Do not use the System in people less than 18 years of age. The System is not approved for use in people under 18 years of age and Sensor readings in this population may be inaccurate. In general, continuous glucose monitoring systems are recognized to be less accurate in children than in adults.
• Do not use the System in critically ill patients. The System is not approved for use in these patients. It is not known how different conditions or medications common to the critically ill population may affect performance of the System. Sensor glucose readings may be inaccurate in critically ill patients.
• Do not use the System in pregnant women or persons on dialysis. The System is not approved for use in pregnant women or persons on dialysis and has not been evaluated in these populations.
• Performance of the System when used with other implanted medical devices, such as pacemakers, has not been evaluated.

What should you know about wearing a Sensor:

• The Sensor can be worn for up to 14 days.
• 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. Remove and replace your Sensor if it starts to loosen and follow the instructions to select an appropriate application site.
• The System uses all available glucose data to give you readings so you should scan your Sensor at least once every 8 hours for the most accurate performance. Scanning less frequently may result in decreased performance.
• 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 inaccurate results.
• If a Sensor breaks inside your body, call your health care professional.

How to Store the Sensor Kit:

• Store the Sensor Kit between 39°F and 77°F. Storage outside of this range may cause inaccurate Sensor glucose readings. While you don’t need to keep your Sensor Kit in a refrigerator, you can as long as the refrigerator is between 39°F and 77°F. Do not freeze.
• 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, Sensor Pack, or Sensor Applicator appear to be damaged or already opened due to risk of no results and/or infection.
• 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 before you Apply the Sensor:

• The Sensor Pack and Sensor Applicator are packaged as a set (separately from the Reader) and have the same Sensor code. Check that the Sensor codes match before using your Sensor Pack and Sensor Applicator. Do not use Sensor Packs and Sensor Applicators with different Sensor codes together as this will result in incorrect glucose readings.
• Clean the application site and ensure that it is dry prior to Sensor insertion. This helps the Sensor stay attached to your body.
• Clean hands prior to Sensor handling/insertion to help prevent infection.
• Change the application site for the next Sensor application to prevent discomfort or skin irritation.
• Sensor placement is not approved for sites other than the back of the 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 interfering substances such as Vitamin C and Aspirin:

• Taking ascorbic acid (vitamin C) while wearing the Sensor may falsely raise Sensor glucose readings. Taking salicylic acid (used in some pain relievers such as aspirin and some skin care products) may slightly lower Sensor glucose readings. The level of inaccuracy depends on the amount of the interfering substance active in the body.
• Test results did not indicate interference for methyldopa (used in some drugs to treat high blood pressure) or tolbutamide (infrequently used in some drugs to treat diabetes in the US) at maximum circulating levels. However, concentrations of potential interferents in interstitial fluid are unknown compared to circulating blood.

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.

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 and apply a new one.
• 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 and apply a new one.

What to do if you are dehydrated:

• Severe dehydration and excessive water loss may cause inaccurate Sensor glucose readings. If you believe you are suffering from dehydration, consult your health care professional immediately.

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 14 day 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.
• 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 in the user manual 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 120°F when it’s charging or 118°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.

ADC-05596 v20.0