FreeStyle ART46937-201 14 day Flash Glucose Monitoring Systems User Manual

FreeStyle ART46937-201 14 day Flash Glucose Monitoring Systems

Product Information

• Product Name: FreeStyle Libre and FreeStyle Libre 14 day Flash Glucose Monitoring Systems
• Model Number: ART46937-201_rev-A
• Indications for Use: Continuous glucose monitoring (CGM) devices indicated for the management of diabetes in persons age 18 and older. They are designed to replace blood glucose testing for diabetes treatment decisions.
• Features:
  • Detects trends and tracks patterns in glucose levels
  • Aids in the detection of episodes of hyperglycemia and hypoglycemia
  • Facilitates acute and long-term therapy adjustments
  • Intended for single patient use
  • Requires a prescription
• Contraindications:
  • The System must be removed prior to Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment
  • MRI, CT scans, or diathermy may damage the Sensor and impact proper function of the device, leading to incorrect readings
• Warnings:

  •   * Do not ignore symptoms that may be due to low or high blood glucose. Consult your healthcare professional if symptoms are inconsistent with your glucose readings

  • Check Sensor glucose readings by conducting a fingerstick test with a blood glucose meter in certain conditions where Sensor readings may not be accurate
• Cautions and Limitations:
  • Review all product information before use
  • Take standard precautions for transmission of blood-borne pathogens to avoid contamination
  • If a Sensor breaks inside your body, call your healthcare professional
  • Do not use if the Sensor Kit package, Sensor Pack, or Sensor Applicator appear to be damaged or already opened
  • Do not use if Sensor Kit contents are past expiration date
  • Do not use if the Reader appears to be damaged
  • Check that the Sensor codes on Sensor Pack and Sensor Applicator match before use
  • Do not use Sensor Packs and Sensor Applicators with different Sensor codes together as this will result in incorrect glucose readings

Product Usage Instructions

1. Before using the system, review all product information provided.
2. Ensure that the Sensor Kit package, Sensor Pack, and Sensor Applicator are not damaged or already opened. Do not use if they appear to be damaged or opened.
3. Check the expiration date of the Sensor Kit contents. Do not use if they are past the expiration date.
4. If using the Reader, ensure it is not damaged. Do not use if it appears to be damaged.
5. Make sure the Sensor codes on the Sensor Pack and Sensor Applicator match before using them. Do not use Sensor Packs and Sensor Applicators with different Sensor codes together.
6. Prior to Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment, remove the System as it may be damaged by exposure to these procedures.
7. Do not ignore symptoms that may be due to low or high blood glucose. If symptoms are inconsistent with your glucose readings, consult your healthcare professional.
8. In certain conditions where Sensor glucose readings may not be accurate, conduct a fingerstick test with a blood glucose meter to check the readings.
9. Take standard precautions for transmission of blood-borne pathogens to avoid contamination.
10. If a Sensor breaks inside your body, immediately call your healthcare professional for assistance.

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User’s Manual Manual del usuario English Español

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User’s Manual

Important Safety Information

Online Labeling
The latest version of the User’s Manual, including performance data, can always be accessed at www.FreeStyleLibre.us/support/overview.html
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.

Indications for Use
The FreeStyle Libre and FreeStyle Libre 14 day Flash Glucose Monitoring Systems are continuous glucose monitoring (CGM) devices indicated for the management of diabetes in persons age 18 and older. They are designed to replace blood glucose testing for diabetes treatment decisions.
Each System detects trends and track patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long- term therapy adjustments. Interpretation of the Sensor glucose readings should be based on the glucose trends and several sequential readings over time. The Systems are intended for single patient use and require a prescription.
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 e!ect 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.

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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.
If you are using FreeStyle LibreLink app, you must have access to a blood glucose monitoring system as the App does not provide one.

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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 younger 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 di!erent conditions or medications common to the critically ill population may a!ect 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.

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What should you know about wearing a Sensor: After the start-up period, the Sensor can be worn for up to the wear duration specified in your Sensor Kit’s product insert. 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. If you are wearing a FreeStyle Libre 14 day Sensor, all available glucose data is used 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. If you are using both the App and Reader with the same FreeStyle Libre 14 day Sensor, be sure to scan frequently with both devices. 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.

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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 di!erent 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 di!erent from Blood Glucose: Physiological di!erences between the interstitial fluid and capillary blood may result in di!erences in glucose readings between the System and results from a fingerstick test using a blood glucose meter. Di!erences 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

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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 e!ect of Xrays 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 su!ering 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 and FreeStyle Libre 14 day Readers have 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.

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See Using the Reader’s Built-in Meter section of the Reader Kit User’s 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.
What to know about FreeStyle LibreLink: FreeStyle LibreLink installed on a smartphone 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 LibreLink and FreeStyle Libre or FreeStyle Libre 14 day Readers do not share data. For complete information on a device, be sure to scan your Sensor every 8 hours with that device; otherwise, your reports will not include all your data.
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 LibreLink 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.
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.
App Symbols

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App icon Sensor may be inaccurate. Check blood glucose with a test strip before making any treatment decisions Scan button
Direction your glucose is going. See Understanding Your Glucose Readings for more information.
Caution Add/edit notes Manually entered blood glucose result note Add blood glucose result note Food note Insulin note Food + insulin note Exercise note Time change

Main menu

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Multiple/Custom notes
Share report
Additional information
Calendar
Sensor too cold
Sensor too hot
FreeStyle LibreLink Overview
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 iPhone instructions for use for how to use your iPhone. During the first 12 hours after insertion of a FreeStyle Libre 14 day Sensor, Sensor readings will be accompanied by the symbol. Whenever is displayed, a blood glucose test should be performed to confirm the Sensor reading prior to treatment. Talk to your health care professional about how you should use your Sensor glucose information to help manage your diabetes. FreeStyle LibreLink is available for download from the App Store. When you’re ready to start using FreeStyle LibreLink, you’ll prepare and apply a Sensor to the back of your upper arm. You can then use the App to get glucose readings from the Sensor and store your glucose history and notes.
Note:

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The Sensor comes in a FreeStyle Libre or FreeStyle Libre 14 day Sensor kit. See Sensor Kit. The App is not compatible with all smartphones. Before upgrading your smartphone or its operating system, check www.FreeStyleLibre.com.

Security Information

You are responsible for properly securing and managing your smartphone. If you suspect an adverse cybersecurity event related to FreeStyle LibreLink, contact Customer Service. Make sure that your phone and Sensor kit are kept in a safe place, under your control. This is important to help prevent anyone from accessing or tampering with the System. FreeStyle LibreLink is not intended for use on a smartphone 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.
Home Screen
The Home Screen gives you access to information about your glucose and the App. To return to the Home Screen from another screen, go to the Main Menu and tap Home.
Main Menu – Tap to access the Home Screen, Logbook, other history options, and Connected Apps. You can also access Settings, Help, and other information. Glucose Graph – Graph of your stored Sensor glucose readings.

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Scan Button – Tap when you are ready to scan your Sensor. You can either tap the blue box on the Home Screen or at the top right. Glucose Information – Your Time In Range, information about your Last Reading, and average glucose for the last 24 hours.
Sensor Kit
The FreeStyle Libre or FreeStyle Libre 14 day Sensor Kit includes: Sensor Pack Sensor Applicator Product insert
When opening your kit, check that the contents are undamaged and that you have all parts listed. If any parts are missing or damaged, contact Customer Service. The Sensor (only visible after applied) is initially in two parts: one part is in the Sensor Pack and the other part is in the Sensor Applicator. Once prepared and applied to your body, the Sensor measures your glucose using a small, flexible tip that inserts just under the skin. After the start-up period, the Sensor can be worn for up to the wear duration specified in the Sensor Kit’s product insert. Sensor Pack. Used with the Sensor Applicator to prepare the Sensor for use.

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Sensor Applicator. Applies the Sensor to your body.
App Setup
Before using the App for the first time, you must complete the setup. 1. Check that your iPhone is connected to a network (WiFi or cellular). You can then install
FreeStyle LibreLink from the App Store. Tap the App icon to open the App. Note: You only need to be connected to a network for setup, using LibreView, and sharing with other apps. You do not need to be connected to scan a Sensor, add notes, or review your history in the App. 2. Swipe left to view some helpful tips or tap GET STARTED NOW at any point.

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3. Confirm your country/region and tap NEXT. 4. You need a LibreView account to use the App. Follow onscreen instructions to review
legal information and create a new account or login to your existing account. 5. Confirm your glucose unit of measure and tap NEXT. 6. Set your Target Glucose Range and tap NEXT. Work with your health care professional to
determine your Target Glucose Range. Your Target Glucose Range is displayed on glucose graphs in the App and is used to calculate your Time In Range. 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 important information about:
How to understand the My Glucose screen When to do a blood glucose test Where to apply the Sensor Tap NEXT after reviewing each screen. 9. Accept required permissions. 10. Apply a new Sensor and then tap NEXT. Go to Starting Your Sensor. Note: If you need help applying your Sensor, tap HOW TO APPLY A SENSOR or go to Applying Your Sensor.
Applying Your Sensor
CAUTION: The Sensor Pack and Sensor Applicator are packaged together as a set 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 di!erent Sensor codes together as this will result in incorrect glucose readings.

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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. IMPORTANT: Before using your Sensor Pack and 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. 1. Apply Sensors only on the back of your upper arm. If placed in other areas, the Sensor may not function properly and could give inaccurate readings. The application of the Sensor is not approved for other sites. 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 di!erent site other than the one most recently used.
2. Clean application site with an alcohol wipe and allow site to dry before proceeding. This helps the Sensor stay attached to your body. Note: The area MUST be clean and dry, or the Sensor may not stick to the site.

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3. Open the Sensor Pack by peeling the lid o! completely. Unscrew the cap from the Sensor Applicator and set the cap aside. CAUTION: Do NOT use if the Sensor Pack or Sensor Applicator seem to be damaged or already opened. Do NOT use if past expiration date.

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4. Line up the dark mark on the Sensor Applicator with the dark mark on the Sensor Pack. On a hard surface, press down firmly on the Sensor Applicator until it comes to a stop.
5. Lift the Sensor Applicator out of the Sensor Pack.
6. The Sensor Applicator is prepared and ready to apply the Sensor. CAUTION: The Sensor Applicator now contains a needle. Do NOT touch inside the Sensor Applicator or put it back into the Sensor Pack.

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7. Place the Sensor Applicator over the prepared site and push down firmly to apply the Sensor to your body. CAUTION: Do NOT push down on Sensor Applicator until placed over prepared site to prevent unintended results or injury.
8. Gently pull the Sensor Applicator away from your body. The Sensor should now be attached to your skin. Note: Applying the Sensor may cause bruising or bleeding. If there is bleeding that does not stop, remove the Sensor, and contact your health care professional.

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9. Make sure Sensor is secure after application. Put the cap back on the Sensor Applicator. Discard the used Sensor Applicator and Sensor Pack according to local regulations. Note: Tap Help in the Main Menu to access an in-app tutorial on applying a Sensor.
Starting Your Sensor
IMPORTANT: 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 a!ect NFC performance. For example, a bulky or metallic case can interfere with the NFC signal. Keep in mind that the ease of scanning a Sensor may vary between devices. The App requires that your iPhone has date and time enabled to set automatically. You can check this in your iPhone settings.

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When using the App, you should keep your iPhone well charged and be sure you have access to a blood glucose monitoring system.
When you scan your Sensor, you will receive a tone and vibration. If your iPhone’s volume is turned o!, you will not hear the tone.

1. Tap the scan button .

Note: You can either tap the blue box on the Home Screen or

at the top right.

If the Ready to Scan dialog disappears, tap the scan button again.

NFC is now activated and your iPhone is ready to scan the Sensor.

2. Hold the top of your iPhone near the Sensor (this can be done over clothing). Do not move your iPhone until you hear a tone and/or feel a vibration. This completes the scan. 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.
See Troubleshooting for additional error messages.

3. The Sensor can be used to check your glucose after the start-up period. 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 like, you can use a Sensor with both the App and the Reader. To do this, you must start the Sensor with the Reader first and then scan with the App.
Remember that FreeStyle LibreLink and Readers do not share data. For complete information on a device, be sure to scan your Sensor every 8 hours with that device; otherwise, your reports will not include all your data.

Checking Your Glucose

1. Open the App and tap the scan button . Note: If the Ready to Scan dialog disappears, tap the scan button

again.

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2. Hold the top of your iPhone near the Sensor until you hear a tone and/or feel a vibration. 3. The My Glucose screen now 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.
Scan Button – Tap when you are ready to scan your Sensor. Message – Tap for more information. Back – Tap to return to Home screen. Current Glucose – Glucose value from your latest scan. Check Blood Glucose – Tap for more information. When you see this symbol, do a blood glucose test before making treatment decisions. Add Note – Tap to add notes to the glucose reading. Glucose Trend Arrow – Direction your glucose is going. Note Symbol – Tap to review notes you’ve entered. Glucose Graph – Graph of your current and stored glucose readings. Target Glucose Range – The graph shows your target glucose range. Note:
A Sensor can store up to 8 hours of glucose data, so scan it at least once every 8 hours to capture all of your available glucose data.

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The graph will scale to 500 mg/dL to accommodate glucose readings above 350 mg/dL.
The symbol may appear, indicating the smartphone’s time was changed. Gaps in the graph may result or glucose readings may be hidden.
Your current glucose value determines the background color on the My Glucose screen:

Orange – High glucose (above 240 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)

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)
Note: The Glucose Trend Arrow may not always appear with your reading.

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Messages
Below are messages you may see with your glucose readings. LO | HI: If LO appears, your reading is lower than 40 mg/dL. If HI appears, your reading is higher than 500 mg/dL. You can touch the symbol for more information. Check your blood glucose on your finger with a test strip. If you get a second LO or HI result, contact your health care professional immediately.
Low Glucose | High Glucose: If your glucose is higher than 240 mg/dL or lower than 70 mg/dL, you will see a message on the screen. You can touch the symbol for more information and set a reminder to check your glucose.
Glucose Going Low | Glucose Going High: If your glucose is projected to be higher than

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240 mg/dL or lower than 70 mg/dL within 15 minutes, you will see a message on the screen. The background color corresponds to your current glucose value. You can touch the symbol for more information and set a reminder to check your glucose.
You will see this symbol if your glucose reading is less than 70 mg/dL, projected to be less than 70 mg/dL, rapidly changing, has no number or trend arrow, or it is in the first 12 hours of wearing a FreeStyle Libre 14 day Sensor. You can touch the symbol for more information. Check your blood glucose on your finger with a test strip before making treatment decisions.
Note: If you are not sure about a message or reading, contact your health care professional before you do anything.
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. WARNING: The System can replace blood glucose testing except in a few 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:

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Do a blood glucose test if you see the Check Blood Glucose symbol. The symbol means your Sensor glucose reading may not be accurate. For example, there may be times when you get a low glucose reading but you do not actually have low glucose.
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.
Note: The symbol will NOT appear in this situation.
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, and in di!erent situations. 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. Helpful Tips
Confirm your Sensor glucose readings with a blood glucose meter until you understand: Sensor accuracy may vary between Sensors. Sensor accuracy may vary during a Sensor wear session.

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Sensor accuracy may vary in di!erent situations (meals, exercise, first day of use, etc.).
Scan your Sensor often to see how carbs, medication, exercise, illness, 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.
Talk 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.
Making a treatment decision does not just mean taking insulin. Treatment decisions can also include things like taking fast-acting carbs, eating, or even doing nothing and scanning again later.
Your health care professional can also help you to understand when doing nothing and scanning 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 scan again later. Avoid “insulin stacking”.
When not to use Sensor Glucose readings for treatment decisions
Glucose is Falling Quickly or Rising Quickly
Sensor glucose values, which are based on interstitial fluid glucose levels, can be di!erent from blood glucose levels (fingersticks), particularly during times when your blood glucose is changing quickly. For example after eating, taking insulin, or exercising. When glucose levels are falling quickly, glucose readings from the Sensor may be higher than blood glucose levels. On the other hand, when glucose levels are rising quickly, glucose readings from the Sensor may be lower than blood glucose levels. If glucose is rising quickly or falling quickly, you will see the symbol. Whenever you see the symbol, do a blood glucose test and treat based on that result.

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Low Glucose or Glucose Going Low message The System lets you know about hypoglycemia or impending hypoglycemia with a Low Glucose or Glucose Going Low message. These messages may not accurately reflect blood glucose. When there is a Low Glucose or Glucose Going Low message, you will also see the
symbol. Whenever you see the symbol, do a blood glucose test and treat based on that result. No Glucose Trend Arrow When there is no Glucose Trend Arrow, the System can’t tell if your glucose is rising quickly or falling quickly and will display the symbol. Whenever you see the symbol, you should do a blood glucose test and treat based on that result. 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. When there is no Current Glucose you will see the symbol. Whenever you see the symbol, do a blood glucose test and treat based on that result. During the first 12 hours of wearing a FreeStyle Libre 14 day Sensor

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During the first 12 hours of wearing a FreeStyle Libre 14 day Sensor, you should not use glucose readings from the Sensor to make treatment decisions. You will see the symbol displayed during this time, and whenever you see the , do a blood glucose test and treat based on that result.
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.
You Have Low or High Blood Glucose Symptoms
Don’t ignore symptoms that may be due to low or high blood glucose. Do a blood glucose test and treat based on that result.
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.
Note: The symbol will NOT appear in these situations.
When to do Nothing and Scan Again Later
Your health care professional can help you understand when doing nothing and scanning 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 scan again later.
Don’t take a correction dose within 2 hours of your meal dose. This may result in “insulin stacking” and low glucose.

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Making Treatment Decisions – Advanced
After you scan your Sensor, use all of the information on the screen when deciding what to do or what treatment decision to make.
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 for: No Arrow or No Number
You will see the symbol. Do not treat based on Sensor glucose reading. Do a blood glucose test.

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Treatment Decision Considerations for Glucose Trend Arrow:
You will see the symbol. Do not treat based on Sensor glucose reading. Do a blood glucose test.
Treatment Decision Considerations for Glucose Trend Arrow:
Low Glucose (< 70 mg/dL): You will see the symbol. Do not treat based on Sensor glucose reading. Do a blood glucose test. Glucose in Target Range: If you are about to eat, take insulin to cover your meal. Consider taking a little more since glucose is rising. If you have taken insulin recently, do nothing and scan again later. Avoid “insulin stacking”. High Glucose (> 240 mg/dL): If you are about to eat, take insulin to cover your meal. Consider taking a little more since glucose is high and rising. 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 scan again later. Avoid “insulin stacking”.
Treatment Decision Considerations for Glucose Trend Arrow:
Low Glucose (< 70 mg/dL): You will see the symbol. Do not treat based on Sensor glucose reading. Do a blood glucose test. Glucose in Target Range: If you are about to eat, take insulin to cover your meal. If this is between meals, do nothing and scan again later. High Glucose (> 240 mg/dL): If you are about to eat, take insulin to cover your meal. Consider taking a little more since glucose is high. 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 scan again later. Avoid “insulin stacking”.
Treatment Decision Considerations for Glucose Trend Arrow:
Low Glucose (< 70 mg/dL): You will see the symbol. Do not treat based on Sensor

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glucose reading. Do a blood glucose test. Glucose in Target Range: If you are about to eat, take insulin to cover your meal. Consider taking a little less since glucose is falling. If this is between meals, consider eating a snack or fast-acting carbohydrates to stay within target and scan again later. High Glucose (> 240 mg/dL): If you are about to eat, take insulin to cover your meal. Consider taking a little less since glucose is falling. If this is between meals, consider doing nothing and scan again later. Avoid “insulin stacking”.
Treatment Decision Considerations for Glucose Trend Arrow:
You will see the symbol. Do not treat based on Sensor glucose reading. Do a blood glucose test. 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 treatment decision to make. If you are not sure about what to do, consult your health care professional.
What you see – When you wake-up

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What it means

When you wake up, your current glucose is 65 mg/dL and the trend arrow shows it is

changing slowly . There is also a

message at the top of the screen and the

symbol.

Anytime you see the symbol, you should do a blood glucose test before deciding what to do.

What you see – Before breakfast

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What it means Before breakfast, your current glucose is 115 mg/dL. The graph shows that your glucose is going up and so does the trend arrow . Consider what might be causing your glucose to go up and what you might do to prevent a high glucose. For example:
How much insulin should you take before your meal? Since you see , should you consider taking a little more insulin? What you see – After breakfast

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What it means

After breakfast, your current glucose is 108 mg/dL. The trend arrow shows it is going down

quickly . There is also a

message at the top of the screen and the symbol.

Anytime you see the symbol, you should do a blood glucose test before deciding what to do.

What you see – Before lunch

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What it means When you checked your glucose before lunch, it was 90 mg/dL and rising. Before eating lunch, you took enough insulin to cover the meal and a little more since your trend arrow was . What you see – After lunch

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What it means 90 minutes later, your current glucose is 225 mg/dL. The graph shows that your glucose is still going up, and so does the trend arrow . Don’t take a correction dose within 2 hours of your meal dose. This may result in “insulin stacking” and low glucose. 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 e!ect? Scan your Sensor again later. What you see – After exercising

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What it means After exercising, you are feeling shaky, sweaty, and dizzy ­ symptoms you generally get when you have low glucose. But, your current glucose is 204 mg/dL. Anytime you get a reading that doesn’t match how you feel, do a blood glucose test. Note: The Check Blood Glucose symbol will NOT appear in this situation. What you see – Before dinner

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What it means Before dinner, your current glucose is 134 mg/dL. The graph shows that your glucose is going down and so does the trend arrow . Consider what might be causing your glucose to go down and what you might do to prevent a low glucose. For example:
How much insulin should you take to cover your meal? Since you see , should you think about taking a little less insulin? What you see – After dinner

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What it means After dinner, your current glucose is 215 mg/dL but there is no trend arrow. There is also the
symbol on the screen. Anytime you see the symbol, you should do a blood glucose test before deciding what to do. Other considerations Deciding how much rapid-acting insulin to take for di!erent meals and situations can be di$cult. Work with your health care professional to discuss di!erent 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?

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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?
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 di!erent types of exercise or activities? How do you adjust your insulin doses for stress? How do you adjust your insulin doses for illness?
Adding Notes
Notes can be saved with your glucose readings to help you track food, insulin, and exercise. You can also add your own comment.
1. Tap the symbol on your glucose reading 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

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Insulin notes: Enter the number of units taken Exercise notes: Enter intensity and duration Note: You cannot add a blood glucose result note to a glucose reading. See Reviewing Your History for how to enter blood glucose results in the App’s Logbook. 3. Tap DONE to save your note. Notes you add are shown on your glucose graph and in your Logbook as symbols. You can review a note by tapping its symbol on your glucose graph or by going to the Logbook. See Reviewing Your History for more information about the Logbook. To edit a note from the glucose graph, tap the symbol and then tap on the information you would like to change. Tap DONE when you are finished.
Food
Insulin
Exercise
Food + insulin
Multiple/Custom notes ­ indicates di!erent 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.
Reviewing Your History
Reviewing and understanding your glucose history can be an important tool for improving your glucose control. The App stores about 90 days of information and has several ways to review your past glucose readings and notes. From the Main Menu, tap Logbook to view the Logbook or tap on one of the other history options under Reports. IMPORTANT:
Work with your health care professional to understand your glucose history. FreeStyle LibreLink does not share data with the FreeStyle Libre Reader.

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For complete information on a device, be sure to scan your Sensor every 8 hours with that device; otherwise, your reports will not include all your data.
Logbook
The Logbook contains entries for each time you scanned your Sensor as well as notes you added. If you would like to view a di!erent 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 di!erent date.
The logbook also allows you to record a blood glucose test you performed. To do this, tap the symbol and enter your result. You can enter a result between 20-500 mg/dL but cannot enter LO or HI.
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 10th – 90th 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 Range: A graph showing the percentage of time your Sensor glucose readings were above, below, or within your Target Glucose Range.
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 15 minutes or longer. The total number of events is displayed below the graph. The bar graph displays the low glucose events in di!erent periods of the day.
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 di!erent periods of the day. Readings above or below your Target Glucose Range are yellow, orange, or red. Readings in range are green.

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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.
The graph will scale to 500 mg/dL to accommodate glucose readings above 350 mg/dL. You might see gaps in the graph during times when you have not scanned at least once in 8 hours. 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 scanned your Sensor or viewed your Sensor glucose readings in the App and how much information has been captured from your Sensor.

Note: Tap the

symbol on any report to share a screenshot of the report.

Tap the symbol to view a description of the report.

To view a di!erent 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.

Removing Your Sensor

1. Pull up the edge of the adhesive that keeps your 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.

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2. Discard the used Sensor according to local regulations. See Maintenance and Disposal. When you are ready to apply a new Sensor, follow the instructions in Applying Your Sensor and Starting Your Sensor.
Replacing Your Sensor
Your Sensor automatically stops working after the wear duration specified in your Sensor Kit’s product insert and must be replaced. You should also replace your Sensor if you notice any irritation or discomfort at the application site or if the App 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 and apply a new one.
Setting Reminders
You can create single or repeating reminders to help you remember things like checking your glucose or taking insulin. There is one default reminder to help you remember to check your glucose. This reminder can be changed or disabled but cannot be deleted. 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 smartphone is turned on, sound is set at a level you can hear, and your smartphone’s Do Not Disturb feature is turned o!. If Do Not Disturb is on, you will only see your reminder on the screen. 1. To add a new reminder, go to the Main Menu and tap Reminders. Tap ADD REMINDER.

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2. Name your reminder.

3. Tap the time fields to set the time for the reminder.

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

Note: To delete a reminder, swipe the reminder and tap the check your glucose cannot be deleted.

symbol. The reminder to

Your reminders will be received as notifications that you can swipe or tap to dismiss.

Settings and Other Options in the Main Menu
Settings
App Settings:
Unit of Measurement – View the glucose unit of measure used in the App.
Report Settings – Set the target range you want to be displayed on the App glucose graph. It is also used to calculate your Time In Range. Tap SAVE when you are done.
Carbohydrate Units – Choose grams or servings for food notes that you enter. Tap SAVE when you are done.
Text to Speech – Turn on to have the glucose reading read aloud when you scan the Sensor. You will hear only your current glucose value and trend arrow direction along with whether you need to do a blood glucose test before making treatment decisions. Additional information, such as the glucose graph and any message, are available on your glucose reading screen. Always review your glucose reading to get complete information. Remember that this feature inherits the volume settings on your phone. If your phone volume is turned o!, you will not hear the glucose reading read aloud. Tap SAVE when you are done.
Account Settings:
Account Details – View/change your LibreView account information.
Account Password – Change your LibreView account password.
Account Options – Delete your LibreView account. Deleting your account means you will no longer be able to:

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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 LibreLink 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 di!erent 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 App’s 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.
Activities
Bathing, Showering, and Swimming: Your Sensor is water-resistant and can be worn while bathing, showering, or swimming. Do NOT take your Sensor deeper than 3 ft (1 meter) or immerse it longer than 30 minutes in water.
Sleeping: Your Sensor should not interfere with your sleep. It is recommended that you scan your Sensor before going to sleep and when you wake up because your Sensor holds only 8 hours of data at a time. For example, if you sleep for 9 hours without scanning your Sensor, 1 hour of data will not be collected and a gap will appear on your glucose graph. If you have reminders set to go o! while you are sleeping, place your smartphone nearby.
Traveling by Air: You can safely use your System at all times while on an aircraft: You can continue to get Sensor glucose readings after you put your smartphone in airplane mode. Please note you must comply with requests from the flight crew to not scan your Sensor. Some airport full-body scanners include X-ray or millimeter radio-wave, which you cannot

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expose your Sensor to. The e!ect 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 fullbody scanner, you must remove your Sensor. The Sensor can be exposed to common electrostatic (ESD) and electromagnetic interference (EMI), including airport metal detectors. Note: Changing the time a!ects the graphs, statistics, and settings programmed by time of day since these are dependent on the time setting being accurate. The symbol may appear on your glucose graph indicating a time change. Gaps in the graph may result or glucose readings may be hidden.
Maintenance and Disposal
Maintenance: The Sensor has no serviceable parts.
Disposal: The 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. Contact Customer Service for further information on the appropriate disposal of components.
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 and end the Sensor currently in use. Please call Customer Service if you have any questions.
Problems at the Sensor Application Site
Problem: The Sensor is not sticking to your skin. What it may mean: The site is not free of dirt, oil, hair, or sweat. What to do: 1. Remove the Sensor. 2. Consider shaving and/or cleaning the site with soap and water. 3. Follow the instructions in Applying Your Sensor and Starting Your Sensor.
Problem: Skin irritation at the Sensor application site. What it may mean: Seams or other constrictive clothing or accessories causing friction at the

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site OR you may be sensitive to the adhesive material. What to do: Ensure that nothing rubs on the site. If the irritation is where the adhesive touches skin, contact your health care professional to identify the best solution.
Problems Starting Your Sensor or Receiving Sensor Readings
Display: Sensor Starting Up What it may mean: Sensor is not ready to read glucose. What to do: Wait until the start-up period has completed.
Display: Sensor Ended What it may mean: The Sensor life has ended. What to do: Apply and start a new Sensor.
Display: New Sensor Found What it may mean: You scanned a new Sensor before your previous Sensor ended. What to do: Your smartphone can only be used with one Sensor at a time. If you start a new Sensor, you will no longer be able to scan your old Sensor. If you would like to begin using the new Sensor, select Yes and scan again.
Display: Sensor Error What it may mean: The Sensor is unable to provide a glucose reading. What to do: Scan again after the duration specified in the message. Note: If you are using a FreeStyle Libre 14 day Sensor and receive this error during your first 12 hours of wearing a Sensor, it may mean that your body is still adjusting to the Sensor. Use a blood glucose meter to check your glucose while you wait. You do not need to remove your Sensor.
Display: Glucose Reading Is Unavailable What it may mean: The Sensor is unable to provide a glucose reading. What to do: Scan again in 10 minutes.
Display: Sensor Too Hot What it may mean: Your Sensor is too hot to provide a glucose reading.

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What to do: Move to a location where the temperature is appropriate and scan again in a few minutes.
Display: Sensor Too Cold What it may mean: Your Sensor is too cold to provide a glucose reading. What to do: Move to a location where the temperature is appropriate and scan again in a few minutes.
Display: Check Sensor What it may mean: The Sensor tip may not be under your skin. What to do: Try to start your Sensor again. If you see Check Sensor again on the screen, your Sensor was not applied properly. Apply and start a new Sensor.
Display: Replace Sensor What it may mean: The App has detected a problem with your Sensor. What to do: Apply and start a new Sensor.
Display: Unexpected Application Error What it may mean: The App has detected an unexpected error. What to do: Shut down the App completely and restart.
Display: Incompatible Sensor What it may mean: The Sensor cannot be used with the App. Check that you have installed the app that is compatible with your Sensor. You may need to download a di!erent app if your Sensor is not compatible. What to do: Tap Learn More to find out what Sensors can be used. If you still have questions, call Customer Service.
Display: Scan Error What it may mean: iPhone was unable to scan the Sensor. What to do: Try scanning the Sensor again. Make sure to follow the directions in Starting Your Sensor or Checking Your Glucose sections.
Display: App Permission Required

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What it may mean: A required App permission is turned o!. What to do: Follow the instructions on the screen to turn the permission on.
Customer Service
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 this User’s Manual is available upon request. The latest version of the User’s Manual is available at www.FreeStyleLibre.us/support/overview.html
Sensor Specifications
Sensor glucose assay method: Amperometric electrochemical sensor Sensor glucose reading range: 40 to 500 mg/dL Sensor size: 5mm height and 35mm diameter Sensor weight: 5 grams Sensor power source: One silver oxide battery Sensor life: Up to the wear duration specified in your Sensor Kit’s product insert Sensor memory: 8 hours (glucose readings stored every 15 minutes) Operating temperature: 50°F to 113°F Sensor Applicator and Sensor Pack storage temperature: 39°F to 77°F Operating and storage relative humidity: 10-90%, non-condensing Sensor water resistance and ingress protection: IP27: Can withstand immersion into 3 ft (1 meter) of water for up to 30 minutes. Protected against insertion of objects > 12mm diameter. Operating and storage altitude: -1250 ft (-381 meters) to 10,000 ft (3,048 meters)
Labeling Symbols and Definitions
Consult instructions for use
Temperature limit

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Manufacturer Batch code Unique Device Identifier Type BF applied part Sensor code Do not re-use MR unsafe FCC Declaration of Conformity mark Use-by date Catalog number Serial number Caution Sterilized by irradiation Humidity limitation Do not use if package is damaged. 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.

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Performance Characteristics – FreeStyle Libre Sensor
Clinical Study Overview
Performance of the FreeStyle Libre Flash Glucose Monitoring System (the System) was evaluated in a clinical study. The study was conducted at 4 centers with a total of 48 subjects with diabetes (95.8% Type 1, 4.2% Type 2). All subjects were aged eighteen and older. Subjects in the study required insulin to manage their diabetes. Each subject wore up to two FreeStyle Libre Sensors on the back of the upper arm. During the study, subjects tested their blood glucose using fingerstick capillary samples at least eight times during each day of the study. Subjects used the blood glucose meter built into the FreeStyle Libre Reader. Additionally, subjects had their venous blood glucose analyzed up to 128 times over four separate visits to the clinical center. Venous blood was analyzed using the Yellow Springs Instrument Life Sciences 2300 STAT PlusTM Glucose & Lactate Analyzer (YSI). YSI is a laboratory glucose and lactate analyzer of whole blood and plasma and is a widely recognized standard in laboratory analysis of blood glucose. Glucose readings obtained from the System were compared to glucose readings obtained from the YSI to evaluate the performance of the System. Three lots of Sensors were evaluated in the study.
Agreement with YSI Levels
Agreement between FreeStyle Libre Glucose Measurement (CGM) and venous blood was characterized by using paired CGM and Yellow Springs Instrument measurements (YSI). The accuracy of CGM versus YSI reference was assessed by calculating the percentage of System readings that were within 15%, 20%, 30% and 40% for reference values 80 mg/dL and above, and 15 mg/dL, 20 mg/dL, 30 mg/dL and 40 mg/dL for values below 80 mg/dL when glucose levels are assigned using the YSI values. Overall 91.1% of results were within ±20 mg/dL / 20% of YSI reference.
Agreement with CGM Glucose Levels
Agreement between CGM and venous blood was characterized by using paired CGM and Yellow Springs Instrument measurements (YSI). The accuracy of CGM versus YSI reference was assessed by calculating the percentage of System readings that were within 15%, 20%, 30% and 40% for reference values 80 mg/dL and above, and 15 mg/dL, 20 mg/dL, 30 mg/dL and 40 mg/dL for values below 80 mg/dL. The results are presented in Table 1 for YSI reference. Overall 91.0% of results were within ±20 mg/dL / 20% of YSI reference.
Table 1. Number and Percent of Results within YSI Reference

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CGM Glucose Level (mg/dL)
Overall 40-50 51-80 81-180 181-300 301-400 401-500

Number of CGM-Reference
Pairs 5772
38 461 3236 1799 226 12

Within ±15% / ±15 mg/dL
82.1 44.7 72.2 82.9 84.9 77.0 58.3

Within ±20% / ±20 mg/dL
91.0 57.9 81.1 91.2 93.6 95.1 75.0

Within ±30% / ±30 mg/dL
97.8 81.6 92.0 97.9 99.2 99.6 100.0

Within ±40% / Outside ±40% /

±40 mg/dL

±40 mg/dL

99.3

0.7

94.7

5.3

97.6

2.4

99.3

0.7

99.7

0.3

99.6

0.4

100.0

0.0

Agreement on Day 1 against YSI Reference
The accuracy of CGM versus YSI reference on the first day of Sensor wear was assessed by calculating the percentage of System readings that were within 15%, 20%, 30% and 40% for reference values 80 mg/dL and above, and within 15 mg/dL, 20 mg/dL, 30 mg/dL and 40 mg/dL for values below 80 mg/dL by hourly intervals. The results are presented in Table 2.
Table 2. Number and Percent of Results within YSI Reference

Time Interval (hours)
(0-2) (2-4) (4-6) (6-8)

Number of CGM-Reference
Pairs 81 318 374 369

Within ±15% / ±15mg/dL
69.1 73.9 76.7 79.9

Within ±20% / ±20mg/dL
87.7 84.6 88.0 90.8

Within ±30% / Within ±40% / Outside ±40% /

±30mg/dL

±40mg/dL

±40mg/dL

100.0

100.0

0.0

97.2

99.7

0.3

97.3

99.7

0.3

99.2

100.0

0.0

Overall Accuracy against YSI reference
Accuracy was measured by comparing the absolute relative di!erence between the System and reference YSI glucose values. The absolute relative di!erence measures the level of disagreement between the System and the reference value, but does not tell you whether the System glucose value was, on average, higher or lower than the reference glucose value. The Mean Absolute Relative Di!erence gives an indication of the average percent disagreement between the CGM and the reference. Table 3 shows the overall absolute di!erence measure. Overall the Mean Absolute Relative Di!erence was 9.7% for the comparison with YSI reference. The Median Absolute Relative Di!erence shows that half of the time the System was within 7.7% of the YSI reference.
Table 3. Di!erence Measures with YSI Reference

Number of CGM-Reference Pairs 5772

Median Absolute Relative Di!erence 7.7%

Mean Absolute Relative Di!erence 9.7%

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Agreement with BG Levels
Agreement between the System and capillary blood glucose values (BG) as measured by the Reader’s built-in meter was characterized by using paired System CGM and BG value. The accuracy of CGM versus BG value was assessed by calculating the percentage of System readings that were within 15%, 20%, 30% and 40% for BG values 80 mg/dL and above, and within 15 mg/dL, 20 mg/dL, 30 mg/dL and 40 mg/dL for values below 80 mg/dL. The results are presented in Table 4 for BG values. Overall 84.3% of results were within ±20 mg/dL / 20% of BG values.
Table 4. Number and Percent of Results within BG Values*

CGM Glucose Level (mg/dL)
Overall 40-50 51-80 81-180 181-300 301-400 401-500

Number of CGM-Reference
Pairs 3680
23 288 1722 1193 362 92

Within ±15% / ±15mg/dL
72.8 47.8 65.6 71.7 75.0 76.8 78.3

Within ±20% / ±20mg/dL
84.3 73.9 77.1 82.9 87.3 87.8 85.9

Within ±30% / ±30mg/dL
95.0 87.0 89.6 94.7 96.2 97.2 95.7

Within ±40% / Outside ±40% /

±40mg/dL

±40mg/dL

98.0

2.0

95.7

4.3

97.6

2.4

97.4

2.6

98.4

1.6

99.2

0.8

98.9

1.1

• Comparison to BG was performed using the FreeStyle Libre Reader’s built-in blood glucose meter. Di!erent performance may be expected when compared to other models of blood glucose meters.

Overall Accuracy against BG values

Accuracy was measured by comparing the absolute relative di!erence between the System and BG values. The absolute relative di!erence measures the level of disagreement between the System and the BG value, but does not tell you whether the System glucose value was, on average, higher or lower than the BG glucose value. The Mean Absolute Relative Di!erence gives an indication of the average percent disagreement between the CGM and the BG value. Table 5 shows the overall absolute di!erence measure. Overall the Mean Absolute Relative Di!erence was 12.1% for the comparison with BG value. The Median Absolute Relative Di!erence shows that half of the time the System was within 9.4% of the BG value.

Table 5. Di!erence Measures with BG Value*

Number of CGM-Reference Pairs 3680

Median Absolute Relative Di!erence 9.4%

Mean Absolute Relative Di!erence 12.1%

• Comparison to BG was performed using the FreeStyle Libre Reader’s built-in blood glucose meter. Di!erent performance may be expected when compared to other models of blood glucose meters.

ART46937-201_rev-A 4:04pm 25-JUL-2023

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 Table 6. For example, in the clinical study, when the System glucose results were within the 81 to 120 mg/dL range, actual blood glucose values were less than 40 mg/dL 0% of the time, between 40 and 60 mg/dL 0.2% of the time, between 61 and 80 mg/dL 5.6% of the time, between 81 and 120 mg/dL 75.9% of the time, between 121 and 160 mg/dL 17.6% of the time, between 161 and 200 mg/dL 0.6% of the time, between 201 and 250 mg/dL 0.1% of the time and above 250 mg/dL 0% of the time.
Table 6. Concurrence Analysis by Glucose Level

CGM (mg/dL)

<40*

<40

0.0

40-60

0.7

61-80

0.0

81-120 0.0

121-160 0.0

161-200 0.0

201-250 0.0

251-300 0.0

301-350 0.0

351-400 0.0

401-500 0.0

500

0.0

40-60
19.0 25.2 7.3 0.2 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0

61-80 81-120

61.9 19.0

58.7 15.4

45.8 46.3

5.6

75.9

0.1

13.2

0.0

0.3

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

YSI Glucose Level (mg/dL)

121160

161200

201250

251300

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.6

0.0

0.0

0.0

17.6

0.6

0.1

0.0

72.0 14.3

0.4

0.0

21.9 67.5 10.2

0.1

0.9

28.8 64.5

5.7

0.0

0.3

41.2 53.4

0.0

0.0

1.2

55.3

0.0

0.0

0.0

3.6

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

301350 0.0 0.0 0.0 0.0 0.0 0.0 0.0 5.2 40.6 66.1 25.0 0.0

351400 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 2.9 30.4 33.3 0.0

401500 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 41.7 0.0

500* 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0

N
21 143 356 1222 1435 1087 905 386 170 56 12
0

• Levels out of system dynamic range.

Concurrence Analysis by Glucose Trend Arrow

Trend Arrow accuracy of the system, as assessed by concurrence analysis, is presented in Table 7. For example, in the clinical study, when the trend arrow indicated that glucose was changing slowly (-1 to 1 mg/dL/min ( ), actual glucose levels in the body were falling quickly ( ) 0.3% of the time, falling ( ) 3.7% of the time, changing slowly ( ) 83.0% of the time, rising ( ) 3.9% of the time, and rising quickly ( ) 0.5% of the time.

Table 7. Concurrence Analysis by Glucose Trend Arrow

YSI (mg/dL/min)

CGM

(mg/dL/min)

<-2

[-2,-1] [-1,0] [0,1] [1,2]

2

NA*

N

<-2 ()

26.3

45.5

10.3

1.3

0.0

0.0

16.7

156

ART46937-201_rev-A 4:04pm 25-JUL-2023

-2 to -1()

4.3

-1 to 1 ()

0.3

1 to 2 ()

0.0

2 ()

0.0

NA

2.5

27.0 3.7 0.6 0.0 9.1

54.6 49.4 8.8 2.8 33.1

3.8 33.6 38.6 14.6 20.7

0.6 3.9 33.3 34.9 14.0

0.0 0.5 9.2 40.6 9.1

9.7 8.6 9.4 7.1 11.6

652 4175 477 212 121

• Glucose rate of change not available due to the time di!erence between glucose readings exceeding 30 minutes. Glucose Trend Arrow not available.

Agreement with LO’ andHI’ CGM Reading against YSI Reference

The System reports glucose concentrations between 40 and 500 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 500 mg/dL, it will report asHI’. No measurements were obtained above 500 mg/dL in the clinical study. Table 8 displays the concurrence between the CGM and YSI reference glucose when CGM reads LO’. For example, in the clinical study, when CGM reading wasLO’ YSI glucose values were less than 40 mg/dL 0.0% of the time, above 40 mg/dL 100.0% of the time, above 50 mg/dL 95.2% of the time, above 60 mg/dL 80.9% of the time, above 70 mg/dL 42.8% of the time, and above 80 mg/dL 19.0% of the time.

Table 8. Concurrence Analysis with `LO’ CGM Reading

<40

% of CGM

points in YSI

0.0

range

Number of

CGM points

0

in YSI range

40 100.0
21

YSI (mg/dL)

50

60

95.2

80.9

20

17

70 42.8
9

80 19.0
4

Total 21

Accuracy by Day of Wear
After the 12 hour start-up period, the Sensor can be worn for up to 10 days. To show Sensor performance over time, the absolute relative di!erence between the System and reference YSI glucose values over the wear is presented in Table 9.
Table 9. Di!erence Measures by Day (YSI Reference)

Day

Number of CGM-Reference Pairs

Median Absolute Relative Di!erence (%)

Mean Absolute Relative Di!erence (%)

1

1497

8.7

10.7

4

1470

7.4

9.6

7

1394

7.4

9.1

10

1411

7.5

9.3

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The accuracy of CGM versus YSI reference and BG reference was assessed by calculating the percentage of System readings that were within 15%, 20%, 30% and 40% for reference values 80 mg/dL and above, and 15 mg/dL, 20 mg/dL, 30 mg/dL and 40 mg/dL for values below 80 mg/dL. The results for CGM vs. YSI reference are presented in Table 10.
Table 10. Number and Percent of Results within YSI Reference

Day

Number of CGM-Reference
Pairs

Within ±15% / ±15mg/dL

Within ±20% / ±20mg/dL

Within ±30% / ±30mg/dL

Within ±40% / Outside ±40% /

±40mg/dL

±40mg/dL

1

1497

76.2

87.4

97.9

99.5

0.5

4

1470

82.3

91.4

97.6

99.3

0.7

7

1394

85.0

93.5

98.6

99.3

0.7

10

1411

85.3

92.3

97.9

99.4

0.6

System Glucose Availability
The System is designed to produce a glucose reading after each user initiated scan that is performed after the start-up time, through the wear period. Table 11 shows the number of available glucose readings reported by all Sensors and the expected number based on the total number of scan attempts. Results are shown for Sensors which produced at least one CGM reading during the clinical study over the total wear period. The percentage of available CGM readings is presented in comparison to the number of expected CGM readings. Overall, 99.5% of CGM readings (9,228 CGM readings out of an expected 9,272) were available.
Table 11. CGM Availability

No. CGM No. Scan

%

9228

9272

99.5

Detection of Hypoglycemic and Hyperglycemic Events
Table 12 shows the accuracy of the System’s Glucose Messages in informing the user of low or high glucose events within 15 minutes before or after the true low or high blood glucose value. Percentages are displayed for three di!erent parameters:

Detection Rate ­ amount of time the System displays a Glucose Message correctly.
Missed Detection Rate ­ amount of time the System did not display a Glucose Message when it should have.
False Notification Rate ­ amount of time the System displays a Glucose Message when it shouldn’t have.

ART46937-201_rev-A 4:04pm 25-JUL-2023

For example, in the clinical study, the System was able to detect 85.4% of actual low glucose events (detection rate), but 39.9% of the time a Low Glucose message was displayed in error (false notification rate) and 14.6% of the time a Low Glucose message was not displayed when it should have been (missed detection rate).
Table 12. Detection of Hypoglycemic and Hyperglycemic Events

Type of Notification Notification of Hypoglycemic Events (Low
Glucose message) Notification of Hyperglycemic Events
(High Glucose message) Impending Notification of Hypoglycemic
Events (Glucose Going Low message) Impending Notification of Hyperglycemic
Events (Glucose Going High message)

Notification Status Detection Rate (%) Missed Detection Rate (%) False Notification Rate (%) Detection Rate (%) Missed Detection Rate (%) False Notification Rate (%) Detection Rate (%) Missed Detection Rate (%) False Notification Rate (%) Detection Rate (%) Missed Detection Rate (%) False Notification Rate (%)

15 Minute Interval 85.4 14.6 39.9 95.1 4.9 22.1 95.0 5.0 46.8 97.2 2.8 28.4

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 13 provides data from two separate Sensors worn on 47 subjects at the same time, providing 7,319 real-time pairs of CGM measurements, with a mean CV of 6.0%.
Table 13. Overall between Sensor Precision

Mean Glucose (mg/dL) 175.3

Median CV 4.6

Mean CV 6.0

Number of Subjects 47

Number of Paired Readings 7319

Sensor Wear Duration
After the 12 hour start-up period, the Sensor can be worn for up to 10 days. To estimate how long a Sensor will work over the wear duration, 97 Sensors were evaluated in the clinical study to determine how many days of readings each Sensor provided. Of these 97 Sensors, 75 (77.3%) lasted until the final day of use. 84 Sensors (86.6%) lasted more than 5 days. There were 22 (22.7%) Sensors that failed early, of which 11 (11.3%) failed on or before the fifth day of wear.
Adverse Events

ART46937-201_rev-A 4:04pm 25-JUL-2023
No device related serious adverse events occurred during the study. Mild skin irritations, such as erythema, edema, rash, bleeding, itching, induration, and infection were reported around the insertion site and adhesive area by a moderate frequency of subjects (5 out of 48 or 10.4%). Pain was mostly reported as none with only one instance of mild pain.
Performance Characteristics – FreeStyle Libre 14 day Sensor
Clinical Study Overview
Performance of the FreeStyle Libre 14 day Flash Glucose Monitoring System (the System) was evaluated in a clinical study. The study was conducted at 4 centers with a total of 95 subjects with diabetes (84.2% Type 1, 15.8% Type 2). All subjects were aged eighteen and older. Subjects in the study required insulin to manage their diabetes. Each subject wore up to two Sensors on the back of the upper arm. During the study, subjects tested their blood glucose using fingerstick capillary samples at least eight times during each day of the study. Subjects used the blood glucose meter built into the Reader. Additionally, subjects had their venous blood glucose analyzed up to 112 times over four separate visits to the clinical center. Venous blood was analyzed using the Yellow Springs Instrument Life Sciences 2300 STAT PlusTM Glucose & Lactate Analyzer (YSI). YSI is a laboratory glucose and lactate analyzer of whole blood and plasma and is a widely recognized standard in laboratory analysis of blood glucose. Glucose readings obtained from the System were compared to glucose readings obtained from the YSI to evaluate the performance of the System. Three lots of Sensors were evaluated in the study.
Agreement with YSI Levels
Agreement between the System Glucose Measurement (CGM) and venous blood was characterized by using paired CGM and Yellow Springs Instrument measurements (YSI). The accuracy of CGM versus YSI reference was assessed by calculating the percentage of System readings that were within 15%, 20%, 30% and 40% for reference values 80 mg/dL and above, and 15 mg/dL, 20 mg/dL, 30 mg/dL and 40 mg/dL for values below 80 mg/dL when glucose levels are assigned using the YSI values. Overall 90.7% of results were within ±20 mg/dL / 20% of YSI reference.
Agreement with CGM Glucose Levels
Agreement between CGM and venous blood was characterized by using paired CGM and Yellow Springs Instrument measurements (YSI). The accuracy of CGM versus YSI reference was assessed by calculating the percentage of System readings that were within 15%, 20%, 30% and 40% for reference values 80 mg/dL and above, and 15 mg/dL, 20 mg/dL, 30 mg/dL and 40 mg/dL for values below 80 mg/dL. The results are presented in Table 14 for YSI

ART46937-201_rev-A 4:04pm 25-JUL-2023

reference. Overall 90.9% of results were within ±20 mg/dL / 20% of YSI reference. Table 14. Number and Percent of Results within YSI Reference

CGM Glucose Level (mg/dL)
Overall 40-50 51-80 81-180 181-300 301-400 401-500

Number of CGM-Reference
Pairs 9725
40 741 6112 2513 291 28

Within ±15% / ±15mg/dL
83.0 52.5 58.2 82.2 91.7 89.0 100.0

Within ±20% / ±20mg/dL
90.9 60.0 70.9 90.9 96.9 95.2 100.0

Within ±30% / ±30mg/dL
97.3 80.0 87.9 97.5 99.4 99.7 100.0

Within ±40% / Outside ±40% /

±40mg/dL

±40mg/dL

99.1

0.9

85.0

15.0

94.6

5.4

99.4

0.6

99.8

0.2

99.7

0.3

100.0

0.0

Agreement on Day 1 against YSI Reference
The accuracy of CGM versus YSI reference on the first day of Sensor wear was assessed by calculating the percentage of System readings that were within 15%, 20%, 30% and 40% for reference values 80 mg/dL and above, and within 15 mg/dL, 20 mg/dL, 30 mg/dL and 40 mg/dL for values below 80 mg/dL by hourly intervals. The results are presented in Table 15
Table 15. Number and Percent of Results within YSI Reference

Time Interval (hours)
(0-2]* (2-4] (4-6] (6-8] (8-16] (16-18] (18-20] (20-22] (22-24]

Number of CGM-Reference
Pairs 182 385 375 373 106 303 344 336 155

Within ±15% / ±15mg/dL
77.5 71.2 77.6 78.0 74.5 80.2 80.2 81.3 86.5

Within ±20% / ±20mg/dL
87.9 83.1 86.4 87.9 83.0 89.1 86.6 87.8 93.5

Within ±30% / ±30mg/dL
95.6 94.8 91.7 97.3 97.2 96.7 94.8 97.9 96.1

Within ±40% / Outside ±40% /

±40mg/dL

±40mg/dL

99.5

0.5

98.4

1.6

96.3

3.7

99.5

0.5

100.0

0.0

99.7

0.3

98.8

1.2

98.8

1.2

98.7

1.3

• (0-2] interval includes the 1 hour start-up time. Time interval is not divided to smaller segments due to small number of data pairs.

Overall Accuracy against YSI reference

Accuracy was measured by comparing the absolute relative di!erence between the System

ART46937-201_rev-A 4:04pm 25-JUL-2023

and reference YSI glucose values. The absolute relative di!erence measures the level of disagreement between the System and the reference value, but does not tell you whether the System glucose value was, on average, higher or lower than the reference glucose value. The Mean Absolute Relative Di!erence gives an indication of the average percent disagreement between the CGM and the reference. Table 16 shows the overall absolute di!erence measure. Overall the Mean Absolute Relative Di!erence was 9.4% for the comparison with YSI reference. The Median Absolute Relative Di!erence shows that half of the time the System was within 7.4% of the YSI reference.
Table 16. Di!erence Measures with YSI Reference

Number of CGM-Reference Pairs 9725

Median Absolute Relative Di!erence (%) 7.4

Mean Absolute Relative Di!erence (%) 9.4

Agreement with BG Levels
Agreement between the System and capillary blood glucose values (BG) as measured by the Reader’s built-in meter was characterized by using paired System CGM and BG value. The accuracy of CGM versus BG value was assessed by calculating the percentage of System readings that were within 15%, 20%, 30% and 40% for BG values 80 mg/dL and above, and within 15 mg/dL, 20 mg/dL, 30 mg/dL and 40 mg/dL for values below 80 mg/dL. The results are presented in Table 17 for BG values. Overall 87.0% of results were within ±20 mg/dL / 20% of BG values.
Table 17. Number and Percent of Results within BG Values*

CGM Glucose Level (mg/dL)
Overall 40-50 51-80 81-180 181-300 301-400 401-500

Number of CGM-Reference
Pairs 9234 123 795 4839 2800 563 114

Within ±15% / ±15mg/dL
75.8 52.0 60.5 73.3 83.8 82.4 80.7

Within ±20% / ±20mg/dL
87.0 62.6 71.9 85.9 92.8 93.6 93.0

Within ±30% / ±30mg/dL
96.1 78.0 88.2 96.4 98.4 98.0 97.4

Within ±40% / Outside ±40% /

±40mg/dL

±40mg/dL

98.6

1.4

89.4

10.6

95.0

5.0

98.9

1.1

99.4

0.6

99.3

0.7

98.2

1.8

• Comparison to BG was performed using the Reader’s built-in blood glucose meter. Di!erent performance may be expected when compared to other models of blood glucose meters.

Overall Accuracy against BG values

Accuracy was measured by comparing the absolute relative di!erence between the System and BG values. The absolute relative di!erence measures the level of disagreement between

ART46937-201_rev-A 4:04pm 25-JUL-2023

the System and the BG value, but does not tell you whether the System glucose value was, on average, higher or lower than the BG value. The Mean Absolute Relative Di!erence gives an indication of the average percent disagreement between the CGM and the BG value. Table 18 shows the overall absolute di!erence measure. Overall the Mean Absolute Relative Di!erence was 11.4% for the comparison with BG value. The Median Absolute Relative Di!erence shows that half of the time the System was within 9.1% of the BG value.
Table 18. Di!erence Measures with BG Value *

Number of CGM-Reference Pairs 9234

Median Absolute Relative Di!erence (%) 9.1

Mean Absolute Relative Di!erence (%) 11.4

• Comparison to BG was performed using the Reader’s built-in blood glucose meter. Di!erent performance may be expected when compared to other models of blood glucose meters.

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 Table 19. For example, in the clinical study, when the System glucose results were within the 81 to 120 mg/dL range, actual blood glucose values were less than 40 mg/dL 0% of the time, between 40 and 60 mg/dL 0.1% of the time, between 61 and 80 mg/dL 2.7% of the time, between 81 and 120 mg/dL 68.1% of the time, between 121 and 160 mg/dL 27.7% of the time, between 161 and 200 mg/dL 1.2% of the time, between 201 and 250 mg/dL 0.1% of the time and above 250 mg/dL 0% of the time.

Table 19. Concurrence Analysis by Glucose Level

CGM (mg/dL)

<40*

<40

0.0

40-60

2.8

61-80

0.2

81-120 0.0

121-160 0.0

161-200 0.0

201-250 0.0

251-300 0.0

301-350 0.0

351-400 0.0

401-500 0.0

500

0.0

40-60
44.4 31.0 4.9 0.1 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0

61-80 81-120

33.3 22.2

48.3 17.9

34.0 59.0

2.7

68.1

0.0

7.0

0.0

0.2

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

YSI Glucose Level (mg/dL)

121160

161200

201250

251300

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

2.0

0.0

0.0

0.0

27.7

1.2

0.1

0.0

71.2 20.7

1.0

0.2

11.1 68.8 18.5

1.1

0.3

15.0 72.8 11.6

0.0

0.5

23.5 65.3

0.0

0.0

2.7

33.3

0.0

0.0

0.0

1.4

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

301350 0.0 0.0 0.0 0.0 0.0 0.3 0.3 10.6 56.6 20.8 0.0 0.0

351400 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 7.3 66.7 21.4 0.0

401500 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 11.1 78.6 92.3

500* 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 7.7

N
18 145 636 2498 2625 1762 1186 554 219 72 28 13

ART46937-201_rev-A 4:04pm 25-JUL-2023

• Levels out of system dynamic range.
  Concurrence Analysis by Glucose Trend Arrow
  Trend Arrow accuracy of the System, as assessed by concurrence analysis, is presented in Table 20. For example, in the clinical study, when the trend arrow indicated that glucose was changing slowly (-1 to 1 mg/dL/min ( ), actual glucose levels in the body were falling quickly ( ) 0.2% of the time, falling ( ) 2.6% of the time, changing slowly ( ) 86.6% of the time, rising ( ) 4.2% of the time, and rising quickly ( ) 0.6% of the time.
  Table 20. Concurrence Analysis by Glucose Trend Arrow

CGM

YSI (mg/dL/min)

(mg/dL/min)

<-2

[-2, -1) [-1, 0) [0, 1]

(1, 2]

2

NA*

N

<-2 ()

39.9

42.7

8.4

0.7

0.0

0.0

8.4

143

-2 to -1 ()

4.7

27.2

56.1

5.5

0.3

0.0

6.2

695

-1 to 1 ()

0.2

1 to 2 ()

0.0

2.6

50.2

36.4

4.2

0.6

0.6

5.6

43.4

36.3

9.8

5.8

7786

4.5

717

2 ()

0.0

0.0

1.6

12.6

37.2

43.3

5.3

247

NA

0.6

8.3

27.4

37.5

13.1

4.2

8.9

168

• Glucose rate of change not available due to the time di!erence between glucose readings exceeding 30 minutes. Glucose Trend Arrow not available.

Agreement with LO’ andHI’ CGM Reading against YSI Reference

The System reports glucose concentrations between 40 and 500 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 500 mg/dL, it will report asHI’. Table 21 displays the concurrence between the CGM and YSI reference glucose when CGM reads LO’. For example, in the clinical study, when CGM reading wasLO’, YSI glucose values were less than 40 mg/dL 0.0% of the time, equal to or above 40 mg/dL 100.0% of the time, above 50 mg/dL 83.3% of the time, above 60 mg/dL 55.6% of the time, above 70 mg/dL 33.3% of the time, and above 80 mg/dL 22.2% of the time.

Table 21. Concurrence Analysis with `LO’ CGM Reading

<40

% of CGM

points in YSI

0.0

range

Number of

CGM points

0

in YSI range

40 100.0
18

YSI (mg/dL)

50

60

83.3

55.6

15

10

70 33.3
6

80 22.2
4

Total 18

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Table 22 displays the concurrence between the CGM and YSI reference glucose when CGM reads HI’. For example, in the clinical study, when CGM reading was HI’, YSI glucose values were less than or equal to 200 mg/dL 0% of the time, above 200 mg/dL 100% of the time, above 300 mg/dL 100% of the time, above 400 mg/dL 100% of the time, and above 500 mg/dL 7.7% of the time.
Table 22. Concurrence Analysis with `HI’ CGM Reading

YSI (mg/dL)

N

200

200

300

400

500

% of CGM

points in YSI

0.0

100.0

100.0

100.0

7.7

range

Number of

CGM points in

0

13

13

13

1

13

YSI range

Accuracy by Day of Wear
The Sensor can be worn for up to 14 days. To show Sensor performance over time, the absolute relative di!erence between the System and reference YSI glucose values over the wear duration is presented in Table 23.
Table 23. Di!erence Measures by Day

Day

Number of CGM-Reference Pairs

Median Absolute Relative Di!ference (%)

Mean Absolute Relative Di!erence (%)

1

2563

8.3

10.8

6

2545

7.1

8.5

11

2419

7.4

9.3

14

2198

6.6

9.1

The accuracy of CGM versus YSI reference and BG reference was assessed by calculating the percentage of System readings that were within 15%, 20%, 30% and 40% for reference values 80 mg/dL and above, and 15 mg/dL, 20 mg/dL, 30 mg/dL and 40 mg/dL for values below 80 mg/dL. The results for CGM vs. YSI reference are presented in Table 24.
Table 24. Number and Percent of Results within YSI Reference

Day

Number of CGM-Reference
Pairs

Within ±15% / ±15mg/dL

Within ±20% / ±20mg/dL

Within ±30% / ±30mg/dL

Within ±40% / Outside ±40% /

±40mg/dL

±40mg/dL

1

2563

78.2

87.0

95.6

98.7

1.3

6

2545

87.0

94.5

99.4

99.8

0.2

11

2419

82.3

90.0

98.2

99.9

0.1

14

2198

83.9

91.3

96.2

99.0

1.0

ART46937-201_rev-A 4:04pm 25-JUL-2023

System Glucose Availability
The System is designed to produce a glucose reading after each user initiated scan that is performed throughout the wear period after the start-up time. Table 25 shows the number of available glucose readings reported by all Sensors and the expected number based on the total number of scan attempts. Results are shown for Sensors which produced at least one CGM reading during the clinical study over the total wear period. The percentage of available CGM readings is presented in comparison to the number of expected CGM readings. Overall, 99.6% (18,488 CGM readings out of an expected 18,562) were available.
Table 25. CGM Availability

No. CGM No. Scan

%

18488

18562

99.6

Detection of Hypoglycemic and Hyperglycemic Events
Table 26 shows the accuracy of the System’s Glucose Messages in informing the user of low or high glucose events within 15 minutes before or after the true low or high blood glucose value. Percentages are displayed for three di!erent parameters:

Detection Rate ­ amount of time the System displays a Glucose Message correctly.
Missed Detection Rate ­ amount of time the System did not display a Glucose Message when it should have.
False Notification Rate ­ amount of time the System displays a Glucose Message when it shouldn’t have.

For example, in the clinical study, the System was able to detect 77.6% of actual low glucose events (detection rate), but 52.5% of the time a Low Glucose message was displayed in error (false notification rate) and 22.4% of the time a Low Glucose message was not displayed when it should have been (missed detection rate).
Table 26. Detection of Hypoglycemic and Hyperglycemic Events

Type of Notification
Notification of Hypoglycemic Events (Low
Glucose message)

Notification Status Detection Rate (%) Missed Detection Rate (%) False Notification Rate (%)

15 Minute Interval 77.6 22.4 52.5

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Notification of Hyperglycemic Events (High
Glucose message)
Impending Notification of Hypoglycemic Events (Glucose Going Low message)
Impending Notification of Hyperglycemic Events (Glucose Going High message)

Detection Rate (%) Missed Detection Rate (%) False Notification Rate (%)
Detection Rate (%) Missed Detection Rate (%) False Notification Rate (%)
Detection Rate (%) Missed Detection Rate (%) False Notification Rate (%)

84.7 15.3 10.6 91.6 8.4 58.8 88.8 11.2 15.5

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 27 provides data from two separate Sensors worn on 95 subjects at the same time, providing 15,283 real-time pairs of CGM measurements, with a mean CV of 5.6%.
Table 27. Overall between Sensor Precision

Mean Glucose (mg/dL) 164.2

Median CV 4.2

Mean CV 5.6

Number of Subjects 95

Number of Paired Readings 15283

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, 190 Sensors were evaluated in the clinical study to determine how many days of readings each Sensor provided. Of these 190 Sensors, 136 (71.6%) lasted until the final day of use. 168 Sensors (88.4%) lasted at least 7 days. There were 54 (28.4%) Sensors that failed early, of which 22 (11.6%) failed on or before the seventh day of wear.
Adverse Events
No device related serious adverse events occurred during the study. Mild skin irritations, such as erythema, bruising, bleeding, infection and papule were reported around the insertion site and adhesive area by a small number of subjects in the study (8 out of 95 or 8.4%).

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Electromagnetic Compatibility
The Sensor 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 a!ect the Sensor. The use of accessories, transducers and cables other than those specified by Abbott Diabetes Care may result in increased EMISSIONS or decreased IMMUNITY of the Sensor. The Sensor should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the Sensor should be observed to verify normal operation in the configuration in which it will be used. The Sensor complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) The Sensor may not cause harmful interference, and (2) the Sensor 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.
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.
Emissions test: RF emissions; CISPR 11
Compliance: Group 1
Electromagnetic environment ­ guidance: The System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
Emissions test: RF emissions; CISPR 11
Compliance: Class B
Electromagnetic environment ­ guidance: The System is suitable for use in all establishments, including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic

ART46937-201_rev-A 4:04pm 25-JUL-2023
purposes.
Guidance and manufacturer’s declaration ­ electromagnetic immunity
The Sensor is intended for use in the electromagnetic environment specified below. The customer or the user of the Sensor should assure that it is used in such an environment.
Immunity test: Electrostatic discharge (ESD); IEC 61000-4-2 IEC 60601 test level: ± 8 kV contact; ± 15 kV air Compliance level: ± 8 kV contact; ± 15 kV air Electromagnetic environment ­ guidance: Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Immunity test: Power frequency (50/60 Hz); magnetic field; IEC 61000-4-8 IEC 60601 test level: 30 A/m Compliance level: 30 A/m Electromagnetic environment ­ guidance: Power frequency magnetic fields should be at levels characteristic of a typical location in a typical domestic, commercial, or hospital environment.
Immunity test: Radiated RF; IEC 61000-4-3 IEC 60601 test level: 10 V/m; 80 MHz to 2.7 GHz Compliance level: 10 V/m Electromagnetic environment ­ guidance: Recommended separation distance d = 1.2 P 80 MHz to 800 MHz d = 2.3 P 800 MHz to 2.5 GHz P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b

ART46937-201_rev-A 4:04pm 25-JUL-2023
Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is a!ected by absorption and reflection from structures, objects and people.
a 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 Sensor is used exceeds the applicable RF compliance level above, the Sensor should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Sensor.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

Recommended separation distances between portable and mobile RF communications equipment and the Sensor
The Sensor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Sensor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Sensor as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter
W
0.01 0.1 1 10 100

Separation distance according to frequency of transmitter m

150 kHz to 80 MHz d = 1.2P
0.12 0.38 1.2 3.8 12

80 MHz to 800 MHz d = 1.2P
0.12 0.38 1.2 3.8 12

800 MHz to 2.5 GHz d = 2.3P
0.23 0.73 2.3 7.3 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the

ART46937-201_rev-A 4:04pm 25-JUL-2023
transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is a!ected by absorption and reflection from structures, objects and people.
www.FreeStyleLibre.com Patent: www.abbott.com/patents The sensor housing, FreeStyle, Libre, and related brand marks are marks of Abbott. Other trademarks are the property of their respective owners.
Manufacturer:
©2023 Abbott ART46937-201 Rev. A 07/23

ART46937-201_rev-A 4:04pm 25-JUL-2023

ART46937-201_rev-A 4:04pm 25-JUL-2023

Manual del usuario
Información importante de seguridad
Etiquetado en línea
La última versión del Manual del usuario, incluidos los datos de rendimiento, está siempre disponible en www.FreeStyleLibre.us/support/overview.html
También puede solicitar un ejemplar impreso gratuito a Atención al cliente: 1-855-632-8658, los 7 días de la semana, de 8 a.m. a 8 p.m., hora del Este; no incluye festivos.
Indicaciones de uso
Los sistemas Flash de control de glucosa FreeStyle Libre y FreeStyle Libre 14 day son dispositivos de control continuo de la glucosa (MCG) indicados para controlar la diabetes en personas de 18 años y mayores. Están diseñados para reemplazar las pruebas de glucosa en la sangre para las decisiones relacionadas con el tratamiento de la diabetes.
Cada sistema detecta tendencias y sigue patrones, además de contribuir a la detección de episodios de hiperglucemia e hipoglucemia, facilitando ajustes del tratamiento tanto en casos agudos como a largo plazo. La interpretación de las lecturas de glucosa del sensor debe basarse en las tendencias de glucosa y en varias lecturas secuenciales a lo largo del tiempo. Los sistemas están destinados para uso en un solo paciente y requieren receta médica.
Contraindicaciones
IRM/TAC/diatermia: el sistema se debe quitar antes de obtener una imagen por resonancia magnética (IRM), una tomografía axial computarizada (TAC) o de realizar un tratamiento termoeléctrico (diatermia) de alta frecuencia. No se ha evaluado el efecto que la IRM, la TAC o la diatermia tiene en el rendimiento del sistema. La exposición puede dañar el sensor y alterar el funcionamiento correcto del dispositivo, lo que podría causar que las lecturas sean incorrectas.
Advertencias
No ignore los síntomas que podrían deberse a un nivel bajo o alto de glucosa en sangre: si tiene síntomas que no concuerdan con sus lecturas de glucosa, consulte con su

ART46937-201_rev-A 4:04pm 25-JUL-2023
profesional de la salud. Verifique las lecturas de glucosa del sensor realizando una prueba mediante punción dactilar usando un medidor de glucosa en sangre bajo las siguientes condiciones, cuando las lecturas de glucosa del sensor puedan no ser precisas y no deban usarse para tomar una decisión relacionada con el tratamiento de la diabetes:
Si sospecha que su lectura puede ser inexacta por algún motivo Cuando tiene síntomas que podrían deberse a un nivel bajo o alto de glucosa en sangre Cuando tiene síntomas que no coinciden con las lecturas de glucosa del sensor Durante las primeras 12 horas de uso de un sensor FreeStyle Libre 14 day
En momentos en que la glucosa cambia rápidamente (más de 2 mg/dL por minuto) Cuando la lectura de glucosa del sensor no incluya un número de glucosa actual o una flecha de tendencia de glucosa Para confirmar la hipoglucemia o la hipoglucemia inminente según lo informado por el sensor Cuando vea el símbolo , debe verificar su nivel de glucosa en la sangre con un medidor de glucosa en sangre antes de tomar cualquier decisión relacionada con el tratamiento. Es posible que las lecturas del sensor no reflejen con precisión los niveles de glucosa en la sangre.

ART46937-201_rev-A 4:04pm 25-JUL-2023
Si está utilizando la aplicación FreeStyle LibreLink, debe tener acceso a un sistema de control de glucosa en la sangre ya que la aplicación no proporciona uno. Hipoglucemia asintomática: el sistema no ha sido evaluado para su uso en pacientes con hipoglucemia asintomática y no le alertará automáticamente de un evento de hipoglucemia sin que usted escanee su sensor. Ausencia de alarmas sin un escaneo del sensor: el sistema no tiene alarmas que le notifiquen automáticamente cuando tenga un evento grave de glucosa baja (hipoglucémico) o alta (hiperglucémico) a menos que escanee su sensor. Por ejemplo, el sistema no tiene una alarma que pueda alertarlo o despertarlo cuando esté durmiendo en caso de glucosa alta o baja. Riesgo de atragantamiento: el sistema contiene piezas pequeñas que pueden ser peligrosas si se ingieren.
Precauciones y limitaciones
A continuación, se encuentran las precauciones y limitaciones importantes que debe tener en cuenta para poder utilizar el sistema de manera segura. Están agrupadas por categorías para que pueda encontrarlas fácilmente.
Qué debe saber sobre alarmas/alertas:

ART46937-201_rev-A 4:04pm 25-JUL-2023
NO hay alarmas ni alertas a menos que escanee el sensor.
Qué debe saber antes de usar el sistema: Revise toda la información del producto antes de usarlo.
Tome las precauciones estándar relacionadas con la transmisión de patógenos presentes en la sangre para evitar la contaminación.
Quiénes no deben usar el sistema: No use el sistema en personas menores de 18 años. El sistema no está aprobado para usarse en personas menores de 18 años y las lecturas del sensor en esta población pueden ser inexactas. En general, se reconoce que los sistemas de control continuo de glucosa son menos precisos en niños que en adultos.
No use el sistema en pacientes con enfermedades graves. El sistema no está aprobado para usarse en estos pacientes. No se sabe cómo las diferentes condiciones o medicamentos comunes a la población con enfermedades graves pueden afectar el rendimiento del sistema. Las lecturas de glucosa del sensor pueden ser inexactas en pacientes con enfermedades graves.
No use el sistema en mujeres embarazadas o personas en diálisis. El sistema no está aprobado para usarse en mujeres embarazadas o personas en diálisis, y no ha sido evaluado en estas poblaciones.
No se ha evaluado el rendimiento del sistema cuando se usa con otros dispositivos médicos implantados, como los marcapasos.
Qué debe saber sobre el uso de un sensor: Después del período inicial, el sensor se puede usar como máximo durante el período de uso especificado en el prospecto del kit del sensor.
Algunas personas podrían ser sensibles al adhesivo que mantiene el sensor sujeto a la piel. Si observa una irritación significativa en la piel alrededor o debajo del sensor, quítese el sensor y deje de usar el sistema. Póngase en contacto con su profesional de la salud antes de seguir usando el sistema.
El ejercicio intenso podría hacer que su sensor se afloje debido a la transpiración o al movimiento del sensor. Quite y cambie su sensor si comienza a aflojarse, y siga las instrucciones para seleccionar un lugar de aplicación adecuado.
Si usa un sensor FreeStyle Libre 14 day, todos los datos de glucosa disponibles se utilizan para proporcionarle lecturas, por lo que debe escanear su sensor al menos una vez cada 8 horas para obtener el rendimiento más preciso. Escanear con menos frecuencia puede provocar una disminución del rendimiento. Si usa la aplicación y el lector con el mismo

ART46937-201_rev-A 4:04pm 25-JUL-2023
sensor FreeStyle Libre 14 day, asegúrese de escanear frecuentemente con ambos dispositivos. No reutilice los sensores. El sensor y el aplicador del sensor están diseñados para un solo uso. Su reutilización puede producir lecturas de glucosa nulas e infección. No son aptos para reesterilizar. Una nueva exposición a radiación puede causar resultados inexactos. Si el sensor se rompe dentro del cuerpo, llame a su profesional de la salud.
Cómo almacenar el kit del sensor: Conserve el kit del sensor entre 39 °F y 77 °F. Almacenarlo fuera de este rango puede generar lecturas de glucosa del sensor inexactas. Si bien no es necesario conservar el kit del sensor en el refrigerador, puede hacerlo siempre que el refrigerador se encuentre entre 39 °F y 77 °F. No congelar. Conserve el kit del sensor a una humedad sin condensación de entre 10 % y 90 %.
Cómo almacenar el lector: Almacene el lector entre -4 °F y 140 °F. El almacenamiento a temperaturas fuera de este rango, como en un coche aparcado en un día caluroso, puede hacer que el lector no funcione correctamente.
Cuándo no usar el sistema: NO lo use si el paquete del kit del sensor, el envase del sensor o el aplicador del sensor parecen estar dañados o si ya están abiertos, ya que puede haber riesgo de que no emita resultados o de que cause infecciones. NO lo use si los contenidos del kit del sensor pasaron la fecha de caducidad. NO lo use si el lector parece estar dañado, ya que puede haber riesgo de choque eléctrico o de que no emita resultados.
Qué debe saber antes de aplicar el sensor: El envase del sensor y el aplicador del sensor están empaquetados como un conjunto (separado del lector) y tienen el mismo código del sensor. Verifique que los códigos del sensor sean los mismos antes de usar el envase del sensor y el aplicador del sensor. No use juntos envases del sensor y aplicadores del sensor con códigos del sensor diferentes, ya que esto producirá lecturas de glucosa incorrectas.

ART46937-201_rev-A 4:04pm 25-JUL-2023
Limpie el lugar de aplicación y asegúrese de que esté seco antes de introducir el sensor. Esto ayuda a que el sensor quede adherido a su cuerpo. Límpiese las manos antes de manipular o introducir el sensor para ayudar a prevenir la infección. Cambie el lugar de aplicación para la siguiente aplicación del sensor a fin de evitar molestias o irritación en la piel. La colocación del sensor no está aprobada para otros lugares que no sean la parte posterior del brazo. Si se coloca en otras áreas, el sensor puede no funcionar correctamente. Elija un sitio apropiado para la colocación del sensor a fin de ayudar a que este quede adherido al cuerpo y evitar molestias o irritación de la piel. Evite las áreas con cicatrices, lunares, estrías o bultos. Seleccione una zona de la piel que, por lo general, permanezca plana durante sus actividades diarias normales (que no se doble ni se pliegue). Seleccione un sitio que esté alejado por lo menos 1 pulgada de los sitios de inyección de insulina.
Cuando la glucosa del sensor es diferente de la glucosa en sangre: Las diferencias fisiológicas entre el líquido intersticial y la sangre capilar podrían producir diferencias en las lecturas de glucosa entre el sistema y los resultados de una prueba mediante punción dactilar usando un medidor de glucosa en sangre. Se pueden observar diferencias en la lectura de glucosa entre el líquido intersticial y la sangre capilar durante los momentos de cambios rápidos de la glucosa en sangre, como después de comer, de aplicar una dosis de insulina o de hacer ejercicio.
Qué debe saber acerca de las sustancias interferentes, como la vitamina C y la aspirina:
Las lecturas de glucosa del sensor podrían aumentar falsamente si se encuentra tomando ácido ascórbico (vitamina C) mientras tiene puesto el sensor. Tomar ácido salicílico (utilizado en algunos analgésicos como la aspirina y algunos productos para el cuidado de la piel) puede reducir ligeramente las lecturas de glucosa del sensor. El nivel de

ART46937-201_rev-A 4:04pm 25-JUL-2023
inexactitud depende de la cantidad de sustancia interferente activa que haya en el cuerpo.
Los resultados de las pruebas no indicaron interferencia con la metildopa (utilizada en algunos medicamentos para tratar la presión arterial alta) o la tolbutamida (utilizada con poca frecuencia en algunos medicamentos para tratar la diabetes en los EE. UU.) en los niveles máximos de circulación. Sin embargo, se desconocen las concentraciones de posibles interferentes en el líquido intersticial en comparación con la sangre circulante.
Qué debe saber sobre los rayos X: El sensor debe retirarse antes de exponerse a una máquina de rayos X. No se ha evaluado el efecto que los rayos X tienen sobre el rendimiento del sistema. La exposición puede dañar el sensor y puede alterar el funcionamiento correcto del dispositivo para detectar tendencias y seguir patrones en los valores de glucosa durante el período de uso.
Cuándo quitar el sensor: Si el sensor se afloja o si la punta del sensor se sale de su piel, es posible que no obtenga ninguna lectura o que la lectura obtenida no sea confiable, y podría no reflejar cómo se siente. Verifique para estar seguro de que el sensor no se haya aflojado. Si se ha aflojado, quíteselo y aplíquese uno nuevo.
Si piensa que su lectura de glucosa no es correcta o no concuerda con la forma en que se siente, realice una prueba de glucosa en sangre en el dedo para confirmarla. Si el problema continúa, quítese el sensor actual y aplíquese uno nuevo.
Qué hacer si está deshidratado: La deshidratación grave y la pérdida excesiva de agua puede generar lecturas de glucosa del sensor inexactas. Si cree que está sufriendo de deshidratación, consulte inmediatamente con su profesional de la salud.
Qué debe saber sobre el lector: NO introduzca el lector en agua u otros líquidos, ya que podría dejar de funcionar correctamente y provocar riesgo de incendio o quemaduras.
Los lectores FreeStyle Libre y FreeStyle Libre 14 day tienen un medidor de glucosa en sangre incorporado que está diseñado para usarse solo con las tiras reactivas para la prueba de glucosa en la sangre FreeStyle Precision Neo y con la solución de control de glucosa y cetonas MediSense. El uso de otras tiras de reactivas con el medidor incorporado del lector producirá un error o hará que el medidor incorporado del lector no se encienda o no inicie una prueba. El medidor incorporado del lector no tiene la funcionalidad para realizar la prueba de cetonas.
El medidor incorporado del lector no debe usarse en pacientes deshidratados,

ART46937-201_rev-A 4:04pm 25-JUL-2023
hipotensos, en estado de shock o en estado hiperglucémico-hiperosmolar, con o sin cetosis.
El medidor incorporado del lector no debe usarse en neonatos ni en pacientes gravemente enfermos, ni para el diagnóstico o detección de la diabetes.
Consulte la sección Cómo usar el medidor incorporado del lector del Manual del usuario del kit del lector para obtener información adicional importante sobre el uso del medidor incorporado del lector.
Lo que debe saber sobre la carga de su lector:
Utilice siempre el adaptador de alimentación eléctrica suministrado por Abbott y el cable USB amarillo que viene con su lector para minimizar el riesgo de incendio o quemaduras. Tenga cuidado al enchufar y desenchufar el cable USB. No fuerce ni doble el extremo del cable USB en el puerto USB del lector.
Elija un lugar para la carga donde pueda acceder fácilmente al adaptador de alimentación eléctrica y desconectarlo rápidamente para evitar el riesgo potencial de descarga eléctrica.
La temperatura máxima de la superficie del lector o del adaptador de alimentación eléctrica puede alcanzar los 120 °F cuando se está cargando o los 118 °F durante el uso normal. En estas condiciones, no sujete el lector ni el adaptador de alimentación eléctrica durante cinco minutos o más. Las personas con trastornos de circulación periférica o de sensibilidad deben tener precaución con esta temperatura.
NO exponga el cable USB ni el adaptador de alimentación eléctrica al agua ni a otros líquidos, ya que podrían dejar de funcionar correctamente y provocar riesgo de incendio o quemaduras.
Qué debe saber sobre la aplicación FreeStyle LibreLink: La aplicación FreeStyle LibreLink instalada en un smartphone está diseñada para ser utilizada por una sola persona. No debe ser utilizada por más de una persona debido al riesgo de malinterpretar la información de glucosa.
La aplicación FreeStyle LibreLink y los lectores FreeStyle Libre o FreeStyle Libre 14 day no comparten datos. Para obtener información completa sobre un dispositivo, asegúrese de escanear su sensor cada 8 horas con ese dispositivo; de lo contrario, sus informes no incluirán todos sus datos.
Desactive las actualizaciones automáticas del sistema operativo (SO) de su teléfono. Antes de actualizar el sistema operativo de su teléfono o de actualizar la aplicación, debe consultar la Guía de compatibilidad de dispositivos móviles y sistemas operativos para determinar si la aplicación FreeStyle LibreLink es compatible con su sistema operativo y su teléfono. La Guía de compatibilidad de sistemas operativos está disponible en la

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sección de Ayuda de la aplicación o en www.FreeStyleLibre.com. Debe consultar periódicamente la Guía de compatibilidad de sistemas operativos para asegurarse de que su sistema operativo y su teléfono siguen siendo compatibles con la aplicación. En caso de que una actualización de la aplicación o del sistema operativo provoque la incompatibilidad de su teléfono previamente compatible, es posible que se le notifique con antelación por correo electrónico o a través de la aplicación. Asegúrese de que su cuenta LibreView tiene su dirección de correo electrónico actual para recibir información importante. Después de actualizar el sistema operativo, abra la aplicación y compruebe la configuración del dispositivo para asegurarse de que funcione correctamente.
Símbolos de la aplicación
Ícono de la aplicación
El sensor puede ser inexacto. Verifique la glucosa en la sangre con una tira de prueba antes de tomar decisiones relacionadas con el tratamiento
Botón de escanear
Dirección de su glucosa. Consulte Comprender sus lecturas de glucosa para más información.
Precaución
Agregar/editar notas
Nota de resultado de glucosa en sangre ingresada manualmente
Añadir nota de resultado de glucosa en sangre
Nota de Alimentos

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Nota de insulina Alimentos + nota de insulina Nota sobre ejercicio Cambio de hora Menú principal Notas múltiples/personalizadas Compartir informe Información adicional Calendario Sensor muy frio Sensor muy caliente
Descripción general de FreeStyle LibreLink
IMPORTANTE: Antes de usar el sistema, revise todas las instrucciones del producto y el tutorial interactivo. Puede acceder al Tutorial interactivo en www.FreeStyleLibre.com. La Guía de referencia rápida y el tutorial interactivo le permiten consultar rápidamente aspectos importantes y limitaciones del sistema. El Manual del usuario incluye toda la información

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de seguridad y las instrucciones de uso. Consulte las instrucciones de uso de su iPhone para saber cómo usarlo. Durante las primeras 12 horas después de introducir un sensor FreeStyle Libre 14 day, las lecturas del sensor estarán acompañadas por el símbolo . Cuando sea que se muestre, se debe realizar una prueba de glucosa en la sangre para confirmar la lectura del sensor antes del tratamiento. Hable con su profesional de la salud acerca de cómo debería usar la información sobre su glucosa del sensor en el tratamiento de su diabetes. La aplicación FreeStyle LibreLink está disponible para su descarga desde la App Store. Cuando esté listo para comenzar a usar FreeStyle LibreLink, preparará y aplicará un sensor en la parte posterior de la parte superior del brazo. Luego podrá usar la aplicación para obtener lecturas de glucosa del sensor y almacenar su historial y notas de glucosa.
Nota: El sensor viene en un kit de sensor FreeStyle Libre o FreeStyle Libre 14 day. Ver Kit del sensor. La aplicación no es compatible con todos los smartphones. Antes de actualizar su smartphone o su sistema operativo, consulte www.FreeStyleLibre.com.
Información de seguridad
Usted es responsable de asegurar y administrar adecuadamente su smartphone. Si sospecha un evento adverso de ciberseguridad relacionado con FreeStyle LibreLink, comuníquese con Atención al cliente. Asegúrese de que el teléfono y el kit del sensor se conserven en un lugar seguro, bajo su control. Esto es importante para ayudar a evitar que alguien acceda al sistema o lo manipule. FreeStyle LibreLink no está diseñado para usarse en un smartphone que ha sido alterado o personalizado para eliminar, reemplazar o eludir la configuración aprobada por el fabricante o la restricción de uso, o que viola la garantía del fabricante.
Pantalla de inicio
La pantalla de Inicio le proporciona acceso a la información acerca de su glucosa y de la aplicación. Para volver a la pantalla de Inicio desde otra pantalla, vaya al menú principal y pulse Inicio.

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Menú principal: pulse para acceder a la pantalla de Inicio, a las el Libro de registro, otras opciones de historial y las Aplicaciones conectadas. También puede acceder a Configuración, Ayuda y otra información. Gráfico de glucosa: gráfico de las lecturas de glucosa del sensor almacenadas. Botón de escanear: pulse cuando esté listo para escanear su sensor. Puede pulsar el botón azul en la pantalla de Inicio o en la esquina superior derecha. Información de glucosa: su tiempo en rango, información sobre su última lectura y la glucosa promedio durante las últimas 24 horas.
Kit del sensor
El kit del sensor FreeStyle Libre o FreeStyle Libre 14 day incluye lo siguiente: Envase del sensor

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Aplicador del sensor Prospecto del producto Al abrir su kit, verifique que el contenido no esté dañado y que incluya todas las piezas de la lista. Si alguna de las piezas falta o está dañada, comuníquese con Atención al cliente. El sensor (que solo es visible una vez que se aplica) inicialmente viene en dos piezas: una pieza es el envase del sensor y la otra es el aplicador del sensor. Una vez preparado y aplicado a su cuerpo, el sensor mide su glucosa utilizando una punta pequeña y flexible que se inserta justo debajo de la piel. Después del período inicial, el sensor se puede usar como máximo durante el período de uso especificado en el prospecto del kit del sensor. Envase del sensor. Se usa con el aplicador del sensor a fin de prepararlo para su uso.
Aplicador del sensor. Para aplicarse el sensor en el cuerpo.

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Configuración de la aplicación
Antes de usar la aplicación por primera vez, debe configurarla. 1. Compruebe que su iPhone esté conectado a una red (WiFi o celular). Luego podrá instalar
la aplicación FreeStyle LibreLink desde la App Store. Pulse el ícono de la aplicación para abrir la aplicación. Nota: Solo necesita estar conectado a una red para configurar, usar LibreView y compartir con otras aplicaciones. No necesita estar conectado para escanear un sensor, agregar notas o revisar su historial en la aplicación. 2. Deslice hacia la izquierda para ver algunos consejos útiles o pulse EMPEZAR AHORA en cualquier momento. 3. Confirme su país/región y pulse SIGUIENTE. 4. Necesita una cuenta LibreView para usar la aplicación. Siga las instrucciones en pantalla para revisar la información legal y crear una nueva cuenta o inicie sesión en su cuenta existente. 5. Confirme su unidad de medida de glucosa y pulse SIGUIENTE. 6. Establezca su rango deseado de glucosa y pulse SIGUIENTE. Trabaje con su profesional de la salud para determinar su rango deseado de glucosa. El rango deseado de glucosa se muestra en los gráficos de glucosa de la aplicación y se utiliza para calcular el tiempo en rango. 7. Seleccione cómo contar los carbohidratos (en gramos o porciones) y pulse SIGUIENTE. La unidad de carbohidratos se usará en las notas de alimentos que ingrese en la aplicación.

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8. La aplicación ahora muestra información importante sobre lo siguiente: Cómo entender la pantalla Mi Glucosa Cuándo hacer una prueba de glucosa en la sangre Dónde aplicarse el sensor
Pulse SIGUIENTE después de revisar cada pantalla. 9. Acepte los permisos requeridos. 10. Aplique un nuevo sensor y luego pulse SIGUIENTE. Vaya a Cómo iniciar su sensor.
Nota: Si necesita ayuda para aplicar su sensor, pulse CÓMO APLICAR UN SENSOR o vaya a Cómo aplicarse el sensor.
Cómo aplicarse el sensor
PRECAUCIÓN: El envase del sensor y el aplicador del sensor están empaquetados como un conjunto y tienen el mismo código del sensor. Verifique que los códigos del sensor sean los mismos antes de usar el envase del sensor y el aplicador del sensor. No use juntos envases del sensor y aplicadores del sensor con códigos del sensor diferentes, ya que esto producirá lecturas de glucosa incorrectas.
El ejercicio intenso podría hacer que su sensor se afloje debido a la transpiración o al movimiento del sensor. Quite y cambie su sensor si comienza a aflojarse, y siga las instrucciones para seleccionar un lugar de aplicación adecuado.
IMPORTANTE: Antes de utilizar el envase del sensor y el aplicador del sensor, asegúrese de tener a mano una toallita humedecida con alcohol (alcohol isopropílico al 70%) para preparar el lugar de aplicación. Esto no se incluye en el kit del sensor.

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1. Aplique los sensores solo en la parte posterior del brazo. Si se coloca en otras áreas, es posible que el sensor no funcione correctamente y pueda generar lecturas inexactas. La aplicación del sensor no está aprobada para otros lugares. Evite las áreas con cicatrices, lunares, estrías o bultos. Seleccione una zona de la piel que por lo general permanezca plana durante sus actividades diarias normales (que no se doble ni se pliegue). Seleccione un sitio que esté alejado por lo menos 1 pulgada (2.5 cm) del sitio de inyección de insulina. Para evitar molestias o irritación de la piel, debe seleccionar un sitio diferente al último que utilizó.
2. Limpie el lugar de aplicación con una toallita humedecida con alcohol y permita que el lugar se seque antes de continuar. Esto ayuda a que el sensor quede adherido a su cuerpo. Nota: El área DEBE estar limpia y seca, de lo contrario es posible que el sensor no se adhiera al lugar.

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3. Abra el envase del sensor desprendiendo por completo la tapa. Desenrosque el tapón del aplicador del sensor y colóquelo a un lado. PRECAUCIÓN: NO lo use si el paquete del sensor o el aplicador del sensor parecen estar dañados o abiertos. NO lo use después de su fecha caducidad.

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4. Alinee la marca oscura del aplicador del sensor con la marca oscura del envase del sensor. Sobre una superficie dura, oprima firmemente el aplicador del sensor hacia abajo hasta que se detenga.
5. Levante el aplicador del sensor para retirarlo del envase del sensor.
6. El aplicador del sensor está preparado y listo para aplicar el sensor. PRECAUCIÓN: El aplicador del sensor ahora contiene una aguja. NO toque el interior del aplicador del sensor ni lo coloque de nuevo en el envase del sensor.

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7. Coloque el aplicador del sensor sobre el sitio preparado y presione hacia abajo con firmeza para aplicar el sensor en el cuerpo. PRECAUCIÓN: NO presione el aplicador del sensor hasta que se coloque sobre el sitio preparado para evitar resultados no deseados o lesiones.
8. Retire suavemente el aplicador del sensor del cuerpo. El sensor debe quedar colocado en la piel. Nota: La aplicación del sensor puede causar hematomas o sangrado. Si hay sangrado que no se detiene, quite el sensor y comuníquese con su profesional de la salud.

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9. Asegúrese de que el sensor esté firmemente colocado después de la aplicación. Coloque de nuevo el tapón en el aplicador del sensor. Deseche el aplicador del sensor y el envase del sensor usados de conformidad con los reglamentos locales. Nota: Pulse Ayuda en el menú principal para acceder a un tutorial en la aplicación sobre cómo aplicar un sensor.
Cómo iniciar su sensor
IMPORTANTE: La antena de comunicación de campo cercano (NFC) está en el borde superior del iPhone. Mantenga esta área cerca del sensor cuando esté escaneando. Es posible que deba ajustar la distancia de exploración en función de la ropa que lleva puesta. Además de la proximidad y la orientación, otros factores pueden afectar el rendimiento de NFC. Por ejemplo, una caja voluminosa o metálica puede interferir con la señal de NFC. Tenga en cuenta que la facilidad para escanear un sensor puede variar según el dispositivo. La aplicación requiere que su iPhone tenga la fecha y hora habilitadas para configurarse

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automáticamente. Puede verificar esto en la configuración de su iPhone.
Cuando use la aplicación, debe tener el iPhone bien cargado y asegurarse de tener acceso a un sistema de control de glucosa en la sangre.
Cuando escanee su sensor, recibirá un tono y una vibración. Si el volumen de su iPhone está apagado, no escuchará el tono.

1. Pulse el botón de escaneo .

Nota: Puede pulsar el botón azul en la pantalla de Inicio o derecha.

en la esquina superior

Si el cuadro de diálogo Listo para escanear desaparece, pulse el botón de escaneo nuevamente.

NFC ahora está activado y su iPhone está listo para escanear el sensor.

2. Mantenga la parte superior del iPhone cerca del sensor (esto se puede hacer sobre la ropa). No mueva el iPhone hasta que escuche un tono o sienta una vibración. Aquí finaliza el escaneo. Nota: Si necesita ayuda, pulse CÓMO ESCANEAR UN SENSOR para ver un tutorial en la aplicación. También puede acceder a esto más tarde si va al menú principal y luego toca Ayuda.
Si su sensor no se escanea correctamente, puede recibir un error de escaneo.
Consulte Resolución de problemas para ver mensajes de error adicionales.

3. El sensor se podrá usar para verificar su glucosa después del período de inicio. Mientras el sensor se está iniciando, puede navegar fuera de la aplicación. Si las notificaciones están habilitadas, verá una notificación cuando el sensor esté listo.
Nota: Si lo desea, puede usar un sensor con la aplicación y el lector. Para hacer esto, primero debe iniciar el sensor con el lector y luego escanear con la aplicación.
Recuerde que la aplicación FreeStyle LibreLink y los lectores no comparten datos. Para obtener información completa sobre un dispositivo, asegúrese de escanear su sensor cada 8 horas con ese dispositivo; de lo contrario, sus informes no incluirán todos sus datos.

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Verificación de su glucosa
1. Abra la aplicación y pulse el botón de escaneo . Nota: Si el cuadro de diálogo Listo para escanear desaparece, pulse el botón de escaneo nuevamente.
2. Ponga la parte superior del iPhone cerca del sen

References

• Patents | Abbott Products | Abbott U.S.
• FreeStyle Libre Continuous Glucose Monitoring | FreeStyle Libre US
• Continuous Glucose Monitoring (CGM) Systems | FreeStyle Libre US
• Support | Product Guides & Tutorials | FreeStyle Libre (CGM) systems
• Patents | Abbott Products | Abbott U.S.
• Support | Product Guides & Tutorials | FreeStyle Libre (CGM) systems

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