Abbott FreeStyle Libre 2 User Manual
  1. Manuals
  2. Brands
  3. Abbott Manuals
  4. Measuring Instruments
  5. FreeStyle Libre 2
  6. User manual

Abbott FreeStyle Libre 2 User Manual

Flash glucose monitoring system
Hide thumbs Also See for FreeStyle Libre 2:
Table of Contents

Advertisement

Quick Links

FLASH GLUCOSE MONITORING SYSTEM
CAUTION: Federal law restricts this device to
sale by or on the order of a physician.
FreeStyle Libre 2 app
A FreeStyle Libre product
User's Manual

Advertisement

Table of Contents
loading

Related Manuals for Abbott FreeStyle Libre 2

Summary of Contents for Abbott FreeStyle Libre 2

  • Page 1 User’s Manual FLASH GLUCOSE MONITORING SYSTEM FreeStyle Libre 2 app A FreeStyle Libre product CAUTION: Federal law restricts this device to sale by or on the order of a physician.
  • Page 2 Your Name _________________________________________________...
  • Page 3 WARNING: Before you use the FreeStyle Libre 2 System, review all the product instructions and the Interactive Tutorial. The Quick Reference Guide and Interactive Tutorial give you quick access to important aspects and limitations of the System. The User’s Manual includes all safety information and instructions for use.

  • Page 4: Table Of Contents

    FreeStyle Libre 2 app ........
  • Page 5 Checking Your Glucose with the App ..... 47 Understanding Your Glucose Readings ....51 Making Treatment Decisions .
  • Page 6 Using the Reader’s Built-in Meter .....123 Intended Use......... . . 123 Blood Glucose Testing .

  • Page 7: Important Safety Information

    Important Safety Information Indications For Use The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.

  • Page 8: Compatible Devices, Apps, And Software

    Use of the Sensor with devices, apps, and software that are not listed may cause inaccurate glucose readings. FreeStyle Libre 2 app is only compatible with certain mobile devices and operating systems. Please check www.FreeStyleLibre.com for more information about device compatibility before upgrading your phone or its operating system.

  • Page 9: Warnings

    Sensor, if your Sensor glucose reading does not match how you feel, or if the reading does not include a number. • If you are using FreeStyle Libre 2 app, you must have access to a blood glucose monitoring system as the App does not provide one. •...
  • Page 10 What to know about Reader Alarms: • For you to receive alarms, they must be on and your Reader should be within 20 feet of you at all times. The transmission range is 20 feet unobstructed. If you are out of range, you may not receive glucose alarms.
  • Page 11 • If you restart your phone, open your App to make sure it’s working properly. • Glucose alarms you receive do not include your glucose reading so you must scan your Sensor to check your glucose. • The App will ask for phone permissions which are needed to receive alarms.
  • Page 12 • Some operating system features may impact your ability to receive alarms. For example, if you use the iOS Screen Time feature, add FreeStyle Libre 2 to the list of Always Allowed apps to ensure that you receive alarms.
  • Page 13 What to know before using the System: • Review all product information before use. • Take standard precautions for transmission of blood borne pathogens to avoid contamination. • Make sure that your devices and Sensor kits are kept in a safe place, and maintain your devices under your control during use.
  • Page 14 What should you know about wearing a Sensor: • Wash application site on the back of your upper arm using a plain soap, dry, and then clean with an alcohol wipe. This will help remove any oily residue that may prevent the Sensor from sticking properly. Allow site to air dry before proceeding.
  • Page 15 • The System is designed to detect certain conditions which may occur where the Sensor is not working as intended and shut it off, telling you to replace your Sensor. This may occur if the Sensor gets knocked off from the skin or if the System detects that the Sensor may not be performing as intended.
  • Page 16 • Do not reuse Sensors. The Sensor and Sensor Applicator are designed for single use. Reuse may result in no glucose readings and infection. Not suitable for re-sterilization. Further exposure to irradiation may cause unreliable low results. • If a Sensor breaks inside your body, call your health care professional. How to Store the Sensor Kit: •...
  • Page 17 What to know about the System: • The FreeStyle Libre 2 System is intended for use by a single person. It must not be used by more than one person due to the risk of misinterpreting glucose information.
  • Page 18 • Wash application site on the back of your upper arm using a plain soap, dry, and then clean with an alcohol wipe. This will help remove any oily residue that may prevent the Sensor from sticking properly. Allow site to air dry before proceeding.
  • Page 19 When is Sensor Glucose different from Blood Glucose: • Physiological differences between the interstitial fluid and capillary blood may result in differences in glucose readings between the System and results from a fingerstick test using a blood glucose meter. Differences in glucose readings between interstitial fluid and capillary blood may be observed during times of rapid change in blood glucose, such as after eating, dosing insulin, or exercising.
  • Page 20 What to know about the Reader’s Built-in Meter: • The FreeStyle Libre 2 Reader has a built-in blood glucose meter that is designed to be used only with FreeStyle Precision Neo blood glucose test strips and MediSense Glucose and Ketone Control Solution. Using other test strips with the Reader’s built-in meter will produce an error...

  • Page 21: Interfering Substances

    What to know about charging your Reader: • Be sure to select a location for charging that allows the power adapter to be easily unplugged. Do NOT block access to the charger due to the potential risk of electrical shock. •...

  • Page 22: Reader Symbols

    Reader Symbols Symbol What It Means Active Sensor Direction your glucose is going. See Understanding Your Glucose Readings section for more information. Caution View previous/next screen Sound and Vibration ON Sound ON, Vibration OFF Sound OFF, Vibration ON Sound and Vibration OFF Sensor communicating with Reader Sensor not communicating with Reader...
  • Page 23 Symbol What It Means When you see this symbol during the first 12 hours of wearing a Sensor, confirm Sensor glucose readings with a blood glucose test before making treatment decisions. Notes Add more information to notes Food note Rapid-acting insulin note Time changed on Reader Blood glucose test Settings...

  • Page 24: App Symbols

    App Symbols Symbol What It Means App icon Alarms are unavailable Scan button Direction your glucose is going. See Understanding Your Glucose Readings section for more information Caution When you see this symbol during the first 12 hours of wearing a Sensor, confirm Sensor glucose readings with a blood glucose test before making treatment decisions Add/edit notes...
  • Page 25 Symbol What It Means Add blood glucose result note Food note Insulin (Rapid or Long-acting) note Exercise note Time change Main menu Multiple/Custom notes Share report Additional information Calendar Sensor too cold Sensor too hot...

  • Page 26: Getting To Know Your System

    Getting to Know Your System The FreeStyle Libre 2 System (“System”) has two main parts: a disposable Sensor and either a handheld Reader or mobile app to wirelessly scan the Sensor and get your glucose readings. Before you start your Sensor, choose which device you want to use.
  • Page 27 If any parts are missing or damaged, contact Customer Service. Customer Service is available at 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Standard Time. FreeStyle Libre 2 app is available for download from the App Store.

  • Page 28: Sensor Kit

    Sensor Kit The Sensor Kit includes: • • Sensor Pack Alcohol wipe • • Sensor Applicator Product insert Sensor Pack Sensor Applicator Used with the Sensor Applicator to Applies the Sensor to your body. prepare the Sensor for use. The Sensor (only visible after applied) measures and stores glucose readings when worn on your body.

  • Page 29: Reader Kit

    To use the built-in meter, you need FreeStyle Precision Neo blood glucose test strips, control solution, a lancing device, and lancets. These items are not included in the Reader kit and must be obtained separately from your FreeStyle Libre 2 System provider (pharmacy or mail order supplier).

  • Page 30: Freestyle Libre 2 App

    If you suspect an adverse cybersecurity event related to FreeStyle Libre 2, contact Customer Service. • FreeStyle Libre 2 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...

  • Page 31: Reader Home Screen

    Reader Home Screen The Reader Home screen provides access to information about your glucose and the System. You can press the Home Button to get to the Home screen. Battery charge remaining Sound/Vibration setting Current time set on the Reader Signal Status Shows if Sensor is communicating with Reader.

  • Page 32: App Home Screen

    App Home Screen The App 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 Scan Button Tap to access the Home screen, Tap when you are ready to scan your Alarms, Logbook, other history Sensor.

  • Page 33: Reporting Software

    Reporting Software Software can be used to create reports based on glucose readings from FreeStyle Libre 2 Sensors. Go to www.FreeStyleLibre.com and follow onscreen instructions to download and install the compatible software. You are responsible for keeping your computer secure and up to date, for...

  • Page 34: Setting Up Your System For The First Time

    Setting up Your System for the First Time Reader Setup Complete the setup if you want to use the Reader with the Sensor or use the Reader’s built-in meter. Step Action Press the Home Button to turn on the Reader. If prompted, use the touchscreen to select your preferred language for the Reader.
  • Page 35 Step Action Set the Current Date using the arrows on the Current Date touchscreen. Touch next to continue. June 2021 back next Set the Current Time. Touch next to continue. Current Time CAUTION: It is very important to set the time and date correctly.
  • Page 36 Step Action The Reader now displays important information about key topics to help you use the System: • How to understand the Glucose Trend Arrow included on the Glucose Reading screen. • When to do a blood glucose test. • Where to apply the Sensor.

  • Page 37: App Setup

    App Setup Complete the setup if you want to use the App with the Sensor. Note: FreeStyle Libre 2 app is only compatible with certain mobile devices and operating systems. Please check www.FreeStyleLibre.com for more information about device compatibility before upgrading your phone or its operating system.
  • Page 38 LibreView account. LibreView Data Management Software is developed by Newyu, Inc. Use of FreeStyle Libre 2 app requires registration with LibreView, a service provided by Abbott and Newyu, Inc. Confirm your glucose unit of measure and tap NEXT.
  • Page 39 Step Action 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. The App now displays some important information. Accept the requested permissions. Tap NEXT after reviewing each screen.

  • Page 40: Applying Your Sensor

    Applying Your Sensor CAUTION: • The Sensor Pack and Sensor Applicator are FreeStyle Libre Sensor Pack packaged together as a set and have the same Sensor code. Check that the Sensor CODE codes match before using your Sensor XXXXXXXXX Pack and Sensor Applicator. Do not use YYYY-MM-DD Sensor Packs and Sensor Applicators with different Sensor codes together as this will...
  • Page 41 Action Step 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. 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).
  • Page 42 Action Step Open the Sensor Pack by peeling the lid off completely. Unscrew the cap from the Sensor Applicator and set the cap aside. CAUTION: Do NOT use if the Sensor Pack or the Sensor Applicator seem to be damaged or already opened.
  • Page 43 Action Step 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. Place the Sensor Applicator over the prepared site and push down firmly to apply the Sensor to your body.
  • Page 44 Action Step Gently pull the Sensor Applicator away from your body. The Sensor should now be attached to your skin. Sensor 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.

  • Page 45: Starting Your Sensor

    Starting Your Sensor Starting Your Sensor with the Reader Before you start your Sensor, choose which device you want to use. If you start the Sensor with the Reader, you will be unable to use the App to check your glucose or receive alarms. Action Step Press the Home Button to turn on the Reader.
  • Page 46 Action Step Hold the Reader within 1.5 inches (4 cm) of the Sensor to scan it. This starts your Sensor. If sounds are turned on, the Reader beeps when the Sensor has been successfully activated. The Sensor can be used to check your glucose after 60 minutes. New Sensor Starting Up Note: If the Sensor is not successfully scanned...

  • Page 47: Starting Your Sensor With The App

    Starting Your Sensor with the App Before you start your Sensor, choose which device you want to use. If you start the Sensor with the App, you will be unable to use the Reader to check your glucose or receive alarms. IMPORTANT: •...
  • Page 48 Step Action 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.
  • Page 49 Step Action 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.

  • Page 50: Checking Your Glucose

    Checking Your Glucose Checking Your Glucose with the Reader Step Action Turn the Reader on by pressing 10:23pm the Home Button or touch Ends in 14 days Check Glucose from the Home screen. Check Review Glucose History Hold the Reader within 1.5 inches (4 cm) of your Sensor to scan it.
  • Page 51 Step Action The Reader displays your current 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. Add Notes Touch to add notes to Message the glucose reading.
  • Page 52 Step Action 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. • The graph displays glucose readings above 350 mg/dL at 350 mg/dL.

  • Page 53: Checking Your Glucose With The App

    Checking Your Glucose with the App Step Action Open the App and tap the scan button Note: If the Ready to Scan dialog disappears, tap the scan button again. Hold the top of your iPhone near the Sensor until you hear a tone and/or feel a vibration.
  • Page 54 Step Action 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. Back Scan Button Message Glucose Trend Arrow Current Glucose...
  • Page 55 Step Action Scan Button - Tap when you are ready to scan your Sensor. (cont.) Message - Tap for more information. Back - Tap to return to Home screen. Current Glucose - Glucose value from your latest scan. Add Note - Tap to add notes to the glucose reading. Glucose Trend Arrow - Direction your glucose is going.
  • Page 56 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. • The graph will scale to 400 mg/dL to accommodate glucose readings above 350 mg/dL.

  • Page 57: Understanding Your Glucose Readings

    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...
  • Page 58 Messages The following table shows messages you may see with your glucose readings. Reader What To Do Display Display If LO appears, your reading is lower Low Glucose than 40 mg/dL. If HI appears, your reading is higher than 400 mg/dL. You can touch the symbol for more information.
  • Page 59 Reader What To Do Display Display If your glucose is higher than Low Glucose 240 mg/dL or lower than 70 mg/dL, you will see a message on the screen. You can touch the High Glucose symbol for more information and set a reminder to check your 10pm glucose.
  • Page 60 Reader What To Do Display Display During the first 12 hours of Sensor 7:03am Ends in 14 days wear the symbol will display, and you cannot use Sensor values to make treatment decisions during this time. Confirm Sensor glucose readings with a blood 10pm glucose test before making treatment decisions during the...

  • Page 61: Making Treatment Decisions

    Making Treatment Decisions Work with your health care professional to put together a plan for managing your diabetes that includes when to use the System information for making treatment decisions. You should also talk to your health care professional about the best times to scan your Sensor. Consider scanning your Sensor before a period when you will not be monitoring your glucose, such as before driving, exercise or sleeping.

  • Page 62: Making Treatment Decisions - Getting Started

    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.
  • Page 63 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. ◦ Sensor accuracy may vary in different situations (meals, exercise, first ◦...
  • Page 64 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”. • Sensor glucose values, which are based on interstitial fluid glucose levels, can be different from blood glucose levels (fingersticks), particularly during times when your blood glucose is changing quickly.
  • Page 65 When you see the symbol during the first 12 hours of wearing a Sensor During the first 12 hours of Sensor wear the symbol will display, and you cannot use Sensor values to make treatment decisions during this time. Confirm Sensor glucose readings with a blood glucose test before making treatment decisions during the first 12 hours of Sensor wear when you see the symbol.
  • Page 66 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.

  • Page 67: Using Your Glucose Reading To Make A

    Using Your Glucose Reading to Make a Treatment Decision After you scan your Sensor, use all of the information on the screen when deciding what to do or what treatment decision to make. Reader Glucose Trend Arrow Direction your glucose is going Current Glucose Arrow What it means...
  • Page 68 Glucose Trend Arrow Direction your glucose is going Current Glucose Arrow What it means Message Glucose rising quickly Glucose rising Glucose changing slowly Glucose Glucose falling Trend Arrow Glucose falling quickly Glucose Graph Graph of your current and stored glucose readings Food Note Rapid-Acting Insulin Note...
  • Page 69 This table provides some information on how you can factor the Glucose Trend Arrow into your treatment decisions. Remember that you should never make a treatment decision based on the Glucose Trend Arrow alone. Treatment Decision Considerations Glucose Trend Low Glucose Glucose in High Glucose Arrow...
  • Page 70 Treatment Decision Considerations Glucose Trend Low Glucose Glucose in High Glucose Arrow (< 70 mg/dL) Target Range (> 240 mg/dL) Treat low glucose If you are about to eat, If you are about to eat, according to your health take insulin to cover take insulin to cover care professional’s your meal.
  • Page 71 Treatment Decision Considerations Glucose Trend Low Glucose Glucose in High Glucose Arrow (< 70 mg/dL) Target Range (> 240 mg/dL) Treat low glucose If you are about to eat, If you are about to eat, according to your health take insulin to cover take insulin to cover care professional’s your meal.
  • Page 72 Treatment Decision Considerations Glucose Trend Low Glucose Glucose in High Glucose Arrow (< 70 mg/dL) Target Range (> 240 mg/dL) Treat low glucose If you are about to eat, If you are about to eat, according to your health take insulin to cover take insulin to cover your meal.
  • Page 73 Treatment Decision Considerations Glucose Trend Low Glucose Glucose in High Glucose Arrow (< 70 mg/dL) Target Range (> 240 mg/dL) Treat low glucose If you are about to eat, If you are about to eat, according to your health take insulin to cover take insulin to cover care professional’s your meal.
  • Page 74 Example Scenarios Here are some example scenarios to help you understand how to use the information on your screen. Always use all of the information on the screen before deciding what to do or what treatment decision to make. If you are not sure about what to do, consult your health care professional.
  • Page 75 What you see What it means Before breakfast: Before breakfast, your current glucose is 115 mg/dL. The graph shows that Reader your glucose is going up and so does 8:06am Ends in 2 days the trend arrow Consider what might be causing your glucose to go up and what you might do to prevent a high glucose.
  • Page 76 What you see What it means Before lunch: When you checked your glucose before lunch, it was 90 mg/dL and rising. Reader Before eating lunch, you took enough 12:00pm Ends in 3 days insulin to cover the meal and a little more since your trend arrow was 12pm...
  • Page 77 What you see What it means After lunch: 90 minutes later, your current glucose is 225 mg/dL. The graph shows that your Reader glucose is still going up, and so does the 1:30pm Ends in 3 days trend arrow Don’t take a correction dose within 2 hours of your meal dose.
  • Page 78 What you see What it means In the afternoon: Between meals, your current glucose is 72 mg/dL. The Glucose Going Low Reader message tells you that your glucose is Glucose Going projected to be low within 15 minutes. Think about what might be causing your glucose to go low.
  • Page 79 What you see What it means After exercising: After exercising, you are feeling shaky, sweaty, and dizzy – symptoms you Reader generally get when you have low 5:47pm glucose. But, your current glucose is Ends in 9 days 204 mg/dL. Anytime you get a reading that doesn’t match how you feel, do a blood glucose test.
  • Page 80 What you see What it means Before dinner: Before dinner, your current glucose is 134 mg/dL. The graph shows that your Reader glucose is going down and so does 7:34pm Ends in 7 days the trend arrow Consider what might be causing your glucose to go down and what you might do to prevent a low glucose.
  • Page 81 Other considerations Deciding how much rapid-acting insulin to take for different meals and situations can be difficult. Work with your health care professional to discuss different situations and what might work best for you. Here are some questions to consider: Meal dosing •...
  • Page 82 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? •...

  • Page 83: Reader Alarms

    Reader Alarms When in range of the Reader, your Sensor automatically communicates with the Reader to give you Low and High Glucose Alarms. These alarms are on by default. Please read all the information in this section before setting and using alarms.
  • Page 84 IMPORTANT: What to know about glucose alarms • Scan your Sensor often to check your glucose. If you get a Low or High Glucose Alarm, you must obtain a glucose result to determine what to do next. • The Low and High Glucose Alarms should not be used exclusively to detect low or high glucose conditions.
  • Page 85 IMPORTANT: How to prevent missed alarms • Alarms must be kept on for you to receive them and you should ensure that your Reader is within 20 feet of you at all times. The Sensor itself will not issue alarms. •...

  • Page 86: Setting Reader Alarms

    Setting Reader Alarms Work with your health care professional to determine your alarm settings. Step Action From the Home screen, touch the Settings 10:23pm Ends in 14 days . Touch Alarms. symbol Check Review Settings Glucose History Alarms Sound & Vibration Time &...
  • Page 87 Step Action Select the alarm you want to set or turn off. Change Alarm Settings Low Glucose Alarm CAUTION: If alarms are turned off, you will High Glucose Alarm not get a notification when you have low Signal Loss Alarm glucose or high glucose.
  • Page 88 Alarm How to Set The Low Glucose Alarm is on by default. Glucose The alarm level is initially set to Low Glucose Alarm Alarm 70 mg/dL. You can use the arrows to change this value between 60 mg/dL and 100 mg/dL. If the mg/dL alarm is on, you will be notified when your glucose falls below the...
  • Page 89 Alarm How to Set High The High Glucose Alarm is on by default. Glucose The alarm level is initially set to High Glucose Alarm Alarm 240 mg/dL. You can use the arrows to change this value between 120 mg/dL and 400 mg/dL. If the mg/dL alarm is on, you will be notified when your glucose rises above the...
  • Page 90 Action Step When you are finished setting your alarms, Change Alarm touch OK. The Alarms Settings screen now Settings Low Glucose Alarm shows your current alarm settings. Touch OK to return to the main settings menu, or touch High Glucose Alarm Change Alarm Settings to make additional Signal Loss Alarm updates.

  • Page 91: Setting Reader Alarm Sounds

    Setting Reader Alarm Sounds Step Action From the Home screen, touch the 10:23pm Ends in 14 days . Touch Sound & Settings symbol Vibration to change the alarm sounds. Check Review Settings Glucose History Alarms Sound & Vibration Time & Date 1 / 4 Touch the sound or vibration setting you Sound &...

  • Page 92: Using Reader Alarms

    Using Reader Alarms What you See What it Means The Low Glucose Alarm notifies you if your Low Glucose Alarm glucose drops below the level you set. The alarm does not include your glucose reading, so you need to scan your Sensor to check your glucose. Dismiss Alarm &...
  • Page 93 What you See What it Means The Signal Loss Alarm notifies you if your Sensor Signal Loss Alarm has not communicated with the Reader for 20 minutes and you are not receiving Low or High Scan Sensor now? Glucose Alarms. Signal loss could be caused by the Sensor being too far away from the Reader (over 20 feet) or another issue such as an error or problem with your Sensor or Reader.

  • Page 94: App Alarms

    App Alarms FreeStyle Libre 2 app includes several types of alarms. • Optional Glucose Alarms: Low Glucose and High Glucose alarms are turned on by default, but can be turned off or customized to alarm at different glucose levels. The Override Do Not Disturb setting is turned on by default for each of these alarms, so you will receive a visual and audio notification regardless of your phone’s sound or Do Not Disturb settings.
  • Page 95 • Fixed System Alarms: Replace Sensor and Sensor Ended alarms will be delivered when your Sensor needs to be replaced. The App Stopped alarm indicates you have force closed the App. You will receive a visual and audio notification regardless of your phone’s sound or Do Not Disturb settings.
  • Page 96 CAUTION: • For you to receive alarms, your phone should be within 20 feet of you at all times. The transmission range is 20 feet unobstructed. If you are out of range, you may not receive alarms. If you want to receive the App's optional alarms, make sure these are turned on.
  • Page 97 • If your phone is not configured correctly, the App will be in "Alarms Unavailable" state and you will not be able to check your glucose or receive any alarms, including the Urgent Low Glucose Alarm. • To turn on Critical Alerts, and Bluetooth, follow the instructions in the App.
  • Page 98 • Some operating system features may impact your ability to receive alarms. For example, if you use the iOS Screen Time feature, add FreeStyle Libre 2 to the list of Always Allowed apps to ensure that you receive alarms. IMPORTANT: •...
  • Page 99 • If the Sensor is not communicating with the App, you will not receive glucose alarms, and you may miss detecting low glucose or high glucose episodes. You will see the symbol on the screen when the Sensor is not communicating with the App. If the Signal Loss Alarm is on, you will be notified if your Sensor has not communicated with the App for 20 minutes.

  • Page 100: Setting App Alarms

    Setting App Alarms To set or turn off your optional glucose alarms, go to the Main Menu and tap Alarms. Select the alarm you want to change. Work with your health care professional to determine your alarm settings. Low Glucose Alarm Step Action The Low Glucose Alarm is on by default.
  • Page 101 Step Action Override Do Not Disturb for the alarm is on by default. Keep Override Do Not Disturb ON if you want the alarm to always play a sound and appear on the lock screen even if your phone is muted or Do Not Disturb is on. Turn OFF if you want the alarm volume to follow your phone's volume setting, and be silent with Do Not Disturb setting is enabled.
  • Page 102 High Glucose Alarm Step Action The High Glucose Alarm is on by default. The alarm level is initially set to 240 mg/dL. Tap to change this value between 120 mg/dL and 400 mg/dL. If the alarm is on, you will be notified when your glucose rises above the level you set.
  • Page 103 Step Action Tap the back button to return to the main alarm settings screen. Signal Loss Alarm Step Action If the alarm is on, you will be notified when your Sensor has not communicated with the App for 20 minutes and you are not receiving Low or High Glucose Alarms.
  • Page 104 Step Action Override Do Not Disturb for the alarm is on by default. Keep Override Do Not Disturb ON if you want the alarm to always play a sound and appear on the lock screen even if your phone is muted or Do Not Disturb is on. Turn OFF if you want the alarm volume to follow your phone's volume setting, and be silent with Do Not Disturb setting is enabled.

  • Page 105: Using App Alarms

    Using App Alarms What you see What it means Notifies you if your glucose drops below 55 mg/dL. The alarm does not include your glucose reading, so you need to scan your Sensor to check your glucose. Swipe or tap to dismiss the alarm and check your glucose.
  • Page 106 What you see What it means Notifies you if your glucose rises above the level you set. The alarm does not include your glucose reading, so you need to scan your Sensor to check your glucose. Swipe or tap to dismiss the alarm and check your glucose.
  • Page 107 What you see What it means Notifies you if your Sensor has ended. You will not receive glucose alarms after this time unless you start a new Sensor. Remove your Sensor and start a new Sensor to check your glucose. Swipe or tap to dismiss the alarm.
  • Page 108 What you see What it means Notifies you if the App has been closed. The App must be running in the background to receive alarms. Tap the alarm to re-open the App. Note: For all alarms except the App Stopped alarm: If you ignore an alarm, you will receive it again in 5 minutes if the condition still exists.

  • Page 109: Adding Notes To Glucose Readings

    Adding Notes to Glucose Readings Notes can be saved with your glucose readings to help you track things like food, insulin, and exercise. Adding Notes in the Reader You can add a note at the time of your glucose reading or within 15 minutes after your reading was obtained.
  • Page 110 Step Action Select the checkbox next to the notes you would Add Notes like to add. Touch the down arrow to view other Rapid-Acting Insulin note options. After you check the box for food Long-Acting Insulin and insulin notes, the symbol appears to the Food right of the note.

  • Page 111: Adding Notes In The App

    Adding Notes in the App In the App, you can add a note to your glucose reading at anytime. Step Action Tap the symbol on the My Glucose screen. 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.
  • Page 112 Step Action Tap DONE to save your note. Notes are shown on your glucose graphs 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 section for more information about the Logbook.

  • Page 113: Reviewing Your History

    IMPORTANT: • Work with your health care professional to understand your glucose history. • Remember that FreeStyle Libre 2 app and FreeStyle Libre 2 Readers do not share data. Reviewing Your History in the Reader Step...
  • Page 114 Step Action Touch the Review History icon. 10:23pm Ends in 14 days Check Review Glucose History Use the arrows to view the available options. Review History Logbook Daily Graph Daily Patterns Average Glucose Time In Target 1 / 2 Low Glucose Events Sensor Usage...
  • Page 115 Logbook Entries for each time you scanned your Sensor or Logbook performed a blood glucose test. If you entered 23 Feb 10:23am Notes with a glucose reading, the symbol 23 Feb 6:37am appears in that row. For more information about 22 Feb 11:09pm the symbols, see Reader Symbols section.
  • Page 116 Other History Options Use the arrows to view information about your last 7, 14, 30, or 90 days. A graph of your Sensor glucose readings by day. Daily Graph (mg/dL) The graph shows your Target Glucose Range and symbols for food or rapid-acting insulin notes you have entered.
  • Page 117 Information about the average of your Sensor Average Glucose glucose readings. The overall average for the time Average: mg/dL is displayed above the graph. The average is also shown for four different 6-hour periods of the day. Readings above or below your Target Glucose Range are orange, while readings in range are blue.
  • Page 118 A graph showing the percentage of time your Time In Target Sensor glucose readings were above, below, or Above within your Target Glucose Range. In Target Below Target Range 80-140 mg/dL Last 7 Days Time In Target Information about the number of low glucose Low Glucose events measured by your Sensor.

  • Page 119: Reviewing Your History In The App

    Reviewing Your History in the App From the Main Menu, tap Logbook to view the Logbook or tap on one of the other history options under Reports. Logbook The Logbook contains entries for each time you scanned your Sensor as well as notes you added. If you would like to view a different day, tap the symbol or use the arrows.
  • Page 120 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.
  • Page 121 Average Glucose: Information about the average of your Sensor glucose readings. The overall average for the selected time period is displayed below the graph. The average is also shown for different periods of the day. Readings above or below your Target Glucose Range are yellow, orange, or red.
  • Page 122 Sensor Usage: Information about how often you scan your Sensor. This includes the total number of scans, an average of how many times you scanned your Sensor each day, and the percentage of possible Sensor data recorded from your scans. Note: •...

  • Page 123: Removing Your Sensor

    Removing Your Sensor Step Action 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.

  • Page 124: Replacing Your Sensor

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

  • Page 125: Using Reminders

    Using Reminders You can create single or repeating reminders to help you remember things like checking your glucose or taking insulin. You can also set a reminder to remind you to check your alarm settings if you have turned off any of your alarms temporarily.
  • Page 126 Step Action Touch to select how often you want the reminder to Repeat: Once, Daily, or Timer. Note: You can set the reminders for a specific time (e.g. 8:30 am) or as a timer (e.g. 3 hours from the current time). Set the reminder Time using the arrows on the touchscreen.

  • Page 127: Using Reminders In The App

    Using Reminders in the App Note: To receive reminders, make sure notifications for the App are enabled. If you want to receive a sound/vibration with your reminder, ensure that sound/vibration on your smartphone is turned on, sound is set at a level you can hear, and your smartphone’s Do Not Disturb feature is turned off.
  • Page 128 Step Action Tap DONE. You will now see your reminder on the list along with the time you will receive it. Note: • There is one default reminder to help you remember to scan your Sensor. This Scan Sensor reminder can be changed or disabled but cannot be deleted.

  • Page 129: Using The Reader's Built-In Meter

    Intended Use The FreeStyle Libre 2 Reader’s built-in meter is for use outside the body only (in vitro diagnostic use) in the quantitative measurement of glucose in fresh whole blood for self testing by lay users from the fingers. It is not intended to be used for testing neonatal blood samples or for the diagnosis or screening of diabetes.
  • Page 130 IMPORTANT: • Use only FreeStyle Precision Neo test strips. Other test strips may produce inaccurate results. • Read all the instructions in this section. Failure to follow instructions may cause incorrect blood glucose results. Practice the testing procedures before using the Reader’s built-in meter. •...
  • Page 131 IMPORTANT: (cont.) • Inaccurate test strip results may occur in severely hypotensive individuals or patients in shock. • Inaccurate test strip results may occur for individuals experiencing a hyperglycemic-hyperosmolar state, with or without ketosis. • Observe caution when using around children. Small parts may constitute a choking hazard.
  • Page 132 IMPORTANT: (cont.) • Do not put urine on the test strip. • Do not use expired test strips as they may cause inaccurate results. • Do not use at altitudes higher than 10,000 feet above sea level. • Do not use a wet, bent, scratched, or damaged test strip. •...

  • Page 133: Blood Glucose Testing

    Blood Glucose Testing You can use the built-in meter to check your blood glucose, whether you are wearing a Sensor or not. Be sure to read the test strip instructions for use prior to using the built-in meter. Step Action CAUTION: Test on your fingers in accordance with the Intended Use in this section.
  • Page 134 Step Action Check the test strip expiration date. Do not use expired test strips as they may give inaccurate results. Open the foil test strip packet at the notch and tear down to remove the test strip. Use the test strip immediately after removing from the foil packet.
  • Page 135 Step Action Use your lancing device to obtain a blood drop Apply Blood and apply blood to the white area at the end of the test strip. Refer to your lancing device instructions for use if you need help using your lancing device.
  • Page 136 Step Action Note: (cont.) • E-3 means the blood drop is too small, or incorrect test procedure, or there may be a problem with the test strip. • E-4 means the blood glucose level may be too high to be read by the system or there may be a problem with the test strip.
  • Page 137 IMPORTANT: The built-in meter displays results from 20 - 500 mg/dL. Low or high blood glucose results can indicate a potentially serious medical condition. The normal glucose level for a non-diabetic adult is below 100 mg/dL when fasting, and less than 140 mg/dL within two hours of a meal. Consult your health care professional to determine the range that is appropriate for you.
  • Page 138 Display What To Do If your glucose is higher than 240 mg/dL or lower Low Glucose than 70 mg/dL, you will see a message on the screen. You can touch the message button for more information and set a reminder to check High Glucose your glucose.
  • Page 139 Accuracy of the Reader's built-in meter Results from the Reader's built-in meter may vary slightly from your actual blood glucose value. This may be due to slight differences in technique and natural variation in test technology. The table below shows the results of a study where 119 typical users used the built-in meter to check their blood glucose level.

  • Page 140: Control Solution Testing

    Replace the cap securely on the bottle immediately after use. • Do NOT add water or other liquid to the control solution. • Contact your FreeStyle Libre 2 System provider (pharmacy or mail order supplier) for how to obtain control solution.
  • Page 141 Action Step From the Home screen, touch the Settings 10:23pm Ends in 14 days symbol . Scroll down using the arrow and touch Control Solution Test. Check Review Glucose History Reminders Control Solution Test Language 2 / 4 Check the test strip expiration date. Open the foil test strip packet at the notch and tear down to remove the test strip.
  • Page 142 Action Step Insert the test strip with the three black lines facing up. Push the strip until it stops. Note: The Reader’s built-in meter turns off after 2 minutes of inactivity. Shake the control solution bottle to mix the Apply Control Solution solution.
  • Page 143 Action Step You will see a butterfly on the screen while you wait for the result. Do not remove the test strip (cont.) while the butterfly is on the screen. If sounds are turned on, the Reader beeps once when the result is ready.
  • Page 144 Control Solution Results 10:23pm Compare the control solution result to the range printed on the test strip instructions for use. The result on your screen should be in this range. Control solution results are marked on the results screen and in the Logbook with a Control Solution Test symbol.

  • Page 145: Living With Your System

    Living With Your System Activities Activity What You Need To Know Bathing, The Reader is not water-resistant and should Showering, and NEVER be submerged in water or other liquid. Swimming Your Sensor is water-resistant and can be worn while bathing, showering, or swimming. Note: Do NOT take your Sensor deeper than 3 feet (1 meter) or immerse it longer than 30 minutes in water.
  • Page 146 Activity What You Need To Know 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...
  • Page 147 Activity What You Need To Know Traveling by Air You may use your System while on an aircraft, following any requests from the flight crew. IMPORTANT: Alarms will not be issued while your smartphone is in airplane mode unless you enable Bluetooth. •...

  • Page 148: Charging The Reader

    Activity What You Need To Know Traveling by Air • The Sensor can be exposed to common electrostatic (ESD) and electromagnetic (cont.) interference (EMI), including airport metal detectors. You can also keep your Reader on while going through these. Note: Changing the time and date affects the graphs and statistics.
  • Page 149 Please charge the Reader to continue using it. Plug the included USB cable into an electrical outlet using the included power adapter. Then, plug the other end of the USB cable into the USB port on the Reader. CAUTION: • Be sure to select a location for charging Charging that allows the power adapter to be...
  • Page 150 Note: • You must charge the Reader when the battery is low keep using the Reader. • To fully charge the battery, charge the Reader for at least 3 hours. • Only use the USB cable and power adapter included with the system.

  • Page 151: Reader Settings And Information

    Reader Settings and Information You can go to the Settings menu to change many settings on the Reader, like alarm settings, sound & vibration, time & date, and target range. The Settings menu is also where you go to do a Control Solution Test or to check the System Status.
  • Page 152 Action Step Touch the setting you want to change: Alarms – See Reader Alarms section for information on setting alarms Sound & Vibration – Set Reader sound and vibration. These also apply to alarms Time & Date – Change the Time or Date Reminders –...
  • Page 153 Action Step • View Event Logs: A list of events recorded by the Reader, which may be used by Customer Service to help (cont.) troubleshoot your System • Perform a Reader Test: The Reader Test will perform internal diagnostics and allow you to check that the Display is showing all pixels, sounds and vibrations are working, and the Touchscreen is responding when touched...

  • Page 154: App Settings And Other Menu Options

    App Settings and Other Menu Options You can go to the Main Menu to change settings like your LibreView password. You can also access the Connected Apps option, Help, and information about the App. App Settings: Unit of Measurement – View the glucose unit of measure used in the App.
  • Page 155 Account Settings: Account Settings – View/change your LibreView account information. Account Password – Change your LibreView account password. Connected Apps: The Connected Apps option in the Main menu opens a web browser within the App. It lists different apps you can connect with to share your data.

  • Page 156: Maintenance And Disposal

    Maintenance and Disposal Cleaning and Disinfecting the Reader Cleaning and disinfecting your Reader is important to prevent the spread of infectious diseases. The Reader has a mean use life of 3 years and has been validated for 156 cleaning and disinfection cycles (the equivalent of 1 cycle per week for 3 years).
  • Page 157 This device is not intended for use with multiple patients in health care or assisted-use settings such as hospitals, physician offices, or long-term care facilities because it has not been cleared by FDA for use in these settings, including for routine assisted testing or as part of glycemic control procedures.
  • Page 158 To clean and disinfect your Reader, you will need Clorox Healthcare Bleach Germicidal Wipes, EPA Reg. #67619-12. These disinfectant wipes contain a 0.55% Sodium Hypochlorite (NaOCl) solution and have been shown to be safe for use with the Reader. They may be purchased at major online retailers, such as Walmart.com, Amazon.com, and OfficeDepot.com.
  • Page 159 Step Action For disinfection, use a second bleach wipe to wipe all outside surfaces of the Reader until they are wet. Make sure liquid does not get into the test strip and USB ports. Allow the Reader surfaces to remain wet for 60 seconds. Dry with clean paper towel to remove any residual moisture.
  • Page 160 IMPORTANT: If you require assistance or if you notice any signs of deterioration on the Reader (such as clouding or crazing on the display of the Reader, corroding or eroding of the plastic housing, or cracking of plastic housing or display) or if the Reader does not turn on, discontinue use of the Reader and contact Customer Service at 1-855-632-8658.

  • Page 161: Troubleshooting

    Troubleshooting This section lists problems or observations that you may have, the possible cause(s), and recommended actions. 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.

  • Page 162: Reader Does Not Power On

    Reader Does Not Power On Problem What It May Mean What To Do Reader does not Reader battery is Charge the Reader. power on after too low. you press the Home Button or insert a test strip. Reader is outside Move the Reader to a of its operating temperature between...

  • Page 163: Problems At The Sensor Application Site

    Problems at the Sensor Application Site Problem What It May Mean What To Do The Sensor is The site is not free 1. Remove the Sensor. 2. Clean the site with a plain not sticking of dirt, oil, hair, or soap and water and then to your skin.

  • Page 164: Problems Starting Your Sensor Or Receiving

    Problems Starting Your Sensor or Receiving Sensor Readings Display What It May Mean What To Do New Sensor Sensor is not ready Wait until the Sensor start-up Starting to read glucose. period has completed. Up / Sensor Starting Up Scan The Reader is not Hold the Reader within Timeout...
  • Page 165 Display What It May Mean What To Do Signal Loss Sensor has not Make sure your device is within Alarm automatically 20 feet of the Sensor. Try communicated with scanning the Sensor to get a your device in the glucose reading. If the Signal last 20 minutes.
  • Page 166 Display What It May Mean What To Do Scan Error Your device Try scanning again. Make sure was unable to to follow the directions in communicate with Starting Your Sensor or Checking the Sensor. Your Glucose sections. Note: You may need to move away from potential sources of electromagnetic interference.
  • Page 167 Display What It May Mean What To Do Glucose Sensor is unable to Scan again in a few minutes. Reading provide a glucose If using the Reader, move to a Unavailable reading. If using the location where the temperature Reader, this may is appropriate.
  • Page 168 Display What It May Mean What To Do Replace The System has Apply and start a new Sensor. Sensor detected a problem with your Sensor. Sensor Too Your Sensor is too Move to a location where the hot to provide a temperature is appropriate and glucose reading.
  • Page 169 Display What It May Mean What To Do Enable Bluetooth Follow the instructions on Bluetooth Permission was the screen to turn Bluetooth Permission turned off. permission on. You will not be able to use the App to check your glucose or start a new Sensor until Bluetooth permission is turned on.

  • Page 170: Problems Receiving Alarms

    What To Do Incompatible The FreeStyle If you still have questions about Sensor Libre 2 Reader and compatibility, call Customer FreeStyle Libre 2 app Service. can only be used with the FreeStyle Libre 2 Sensor. Problems Receiving Alarms Problem What It May Mean...
  • Page 171 Problem What It May Mean What To Do You are not The Sensor is not The Sensor must be within range receiving communicating with (20 feet) of your device for you alarms. your device. to receive alarms. Make sure that (cont.) you are within this range.
  • Page 172 Problem What It May Mean What To Do You are not Sound/vibration are Check the Reader’s sound and receiving turned off in your vibration settings to confirm glucose Reader settings. sound/vibration are on. alarms. (cont.) One or more of Check to make sure that you the following is have the correct settings and turned off in your...
  • Page 173 Problem What It May Mean What To Do You are not You may have set an Confirm your alarm settings are receiving alarm level that is appropriate. glucose higher or lower than alarms. you intended. (cont.) You have already You will receive another alarm dismissed this type when a new low or high glucose of alarm.
  • Page 174 Problem What It May Mean What To Do You are not If you are using Disconnect headphones or receiving peripherals such as peripherals when you are not glucose wireless headphones using them. alarms. or a smartwatch you (cont.) may receive alarms on only one device or peripheral, not all.

  • Page 175: Blood Glucose Error Messages

    Blood Glucose Error Messages Error What It May Mean What To Do Message The temperature is 1. Move the Reader and test too hot or too cold strips to a location where the for the Reader to temperature is within the test work correctly.
  • Page 176 Error What It May Mean What To Do Message Blood drop is too 1. Review the testing small. instructions. 2. Repeat the test using a new test strip. Incorrect test 3. If the error reappears, contact procedure. Customer Service. There may be a problem with the test strip.
  • Page 177 Error What It May Mean What To Do Message Blood was applied 1. Review the testing to the test strip too instructions. soon. 2. Repeat the test using a new test strip. 3. If the error reappears, contact Customer Service. The test strip may not 1.
  • Page 178 Error What It May Mean What To Do Message Test strip may be 1. Check that you are using damaged, used, or the correct test strip for the Reader does not the Reader. (See test strip recognize it. instructions for use to verify your strip is compatible with the Reader).

  • Page 179: Problems Checking Your Blood Glucose

    Problems Checking Your Blood Glucose Problem What It May Mean What To Do The Reader Test strip is not 1. With the 3 black lines facing does not inserted correctly up, insert the test strip into start a or not inserted fully the strip port until it stops.
  • Page 180 Problem What It May Mean What To Do The test Blood sample is too 1. See test strip instructions does not small. for use for re-application start after instructions. applying 2. Repeat the test using a new the blood test strip. sample.

  • Page 181: Perform A Reader Test

    Perform a Reader Test If you think the Reader is not working properly, you System Status can check the Reader by performing a Reader Test. System Info Touch the Settings symbol from the Home Reader Test screen, select System Status and then select Reader Test.

  • Page 182: System Specifications

    System Specifications See test strip and control solution instructions for use for additional specifications. Sensor Specifications Sensor glucose assay Amperometric electrochemical sensor method Sensor glucose reading 40 to 400 mg/dL range Sensor size 5 mm height and 35 mm diameter Sensor weight 5 grams Sensor power source...
  • Page 183 8 hours (glucose readings stored every Sensor memory 15 minutes) Sensor transmission 20 feet (6 meters) unobstructed range Operating temperature 50 °F to 113 °F Sensor Applicator and Sensor Pack storage 36 °F to 82 °F temperature Operating and storage 10-90%, non-condensing relative humidity IP27: Can withstand immersion into...
  • Page 184 Reader Specifications Blood glucose assay 20 to 500 mg/dL range Reader size 95 mm x 60 mm x 16 mm Reader weight 65 grams Reader power source One lithium-ion rechargeable battery Reader battery life 4 days of typical use Reader memory 90 days of typical use Reader operating 50 °F to 113 °F...
  • Page 185 Operating and storage 10-90%, non-condensing relative humidity Reader moisture Keep dry protection Operating and storage -1,250 ft (-381 meters) to 10,000 ft altitude (3,048 meters) 60 seconds (120 seconds when test Reader display timeout strip is inserted) Near Field Communication (13.56 MHz RFID);...
  • Page 186 Reader cleaning and 3 years, which is 156 cleaning and disinfection disinfection cycles (1 cycle per week for 3 years). Abbott Diabetes Care PRT25611 Power Adapter Operating temperature: 50 °F to 104 °F Abbott Diabetes Care PRT21373 USB Cable Length: 37 inches (94 cm)
  • Page 187 Sensor. Quality of Service (QoS): QoS for the FreeStyle Libre 2 Reader and Sensor wireless communications using NFC is assured within the effective range of 4 cm between the Sensor and Reader that is specified to occur within 15 seconds.
  • Page 188 QoS for the FreeStyle Libre 2 app and Sensor wireless communications using NFC is assured within the effective range of 1 cm between the Sensor and phone. QoS for the FreeStyle Libre 2 app and Sensor wireless communications using BLE is assured at regular 1-minute intervals. If connection is lost between the App and Sensor for 5-minutes, the alarms unavailable symbol displays.

  • Page 189: Labeling Symbols

    Labeling Symbols Consult instructions for Use-by date Temperature limit Catalog number Manufacturer Serial number Batch code Keep dry Type BF applied part Non-ionizing radiation Sensor code Caution CODE Sterilized using Do not re-use irradiation MR unsafe Humidity limitation FCC Declaration of Do not use if package Conformity mark is damaged...
  • Page 190 Not made with natural rubber latex 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.

  • Page 191: Performance Characteristics

    Two studies were conducted in the United States (US) to evaluate the performance, safety, effectiveness, and precision of the FreeStyle Libre 2 Flash Glucose Monitoring System (System). One study included adults (Adult study) and the other study included children (Pediatric study).
  • Page 192 manipulated per the study protocol to raise or lower glucose. This was done to assess performance of the System over the range that the System measures glucose (40 – 400 mg/dL). 48 subjects were analyzed during the beginning of the Sensor wear period (day 1 or 2), 50 subjects were analyzed during the early middle period (day 7 or 8), 51 subjects were analyzed during the late middle period (day 9 or 12), and 51 subjects were analyzed during the end period (day 13 or 14).
  • Page 193 Table 1a: Overall Accuracy to YSI Percent Percent Number of Percent Within Within Subject CGM- Number of Within ±20% / ±20% / MARD (%) Group Reference Subjects ±20% / ±20 mg/dL ±20 mg/dL Pairs ±20 mg/dL in first on Day 1 12 hours Adults 18735...
  • Page 194 Table 1b: Accuracy to YSI within CGM Glucose Ranges (Adult; n=144) Number Percent Percent Percent Percent Percent Percent Mean Glucose of CGM- MARD Within Within Within Within Within Within bias † Level Reference ±15 mg/dL ±20 mg/dL ±40 mg/dL ±15% ±20% ±40% (mg/dL)
  • Page 195 Table 1c: Accuracy to YSI within CGM Glucose Ranges (Pediatric*; n=129) Number Percent Percent Percent Percent Percent Percent Mean Glucose of CGM- MARD Within Within Within Within Within Within bias † Level Reference ±15 mg/dL ±20 mg/dL ±40 mg/dL ±15% ±20% ±40% (mg/dL)
  • Page 196 Table 1d: Accuracy to YSI within YSI Glucose Ranges (Adult; n=144) Number Percent Percent Percent Percent Percent Percent Mean Glucose of CGM- MARD Within Within Within Within Within Within bias Level Reference ±15 mg/dL ±20 mg/dL ±40 mg/dL ±15% ±20% ±40% (mg/dL) (mg/dL)
  • Page 197 Table 1e: Accuracy to YSI within YSI Glucose Ranges (Pediatric*; n=129) Number Percent Percent Percent Percent Percent Percent Mean Glucose of CGM- MARD Within Within Within Within Within Within bias Level Reference ±15 mg/dL ±20 mg/dL ±40 mg/dL ±15% ±20% ±40% (mg/dL) (mg/dL)
  • Page 198 Agreement with ‘LO’ and ‘HI’ CGM Reading against YSI Reference The System reports glucose concentrations between 40 and 400 mg/dL. When the System determines that glucose level is below 40 mg/dL, it will report as ‘LO’ . When the System determines that glucose level is above 400 mg/dL, it will report as ‘HI’...
  • Page 199 Tables 2c and 2d display the concurrence between the CGM and YSI reference glucose when CGM reads ‘HI’ . In the Adult study, when CGM reading was ‘HI’ , YSI glucose values were above 350 mg/dL 97.5% of the time, above 300 mg/dL 100.0% of the time, above 250 mg/dL 100.0 % of the time, and less than or equal to 250 mg/dL 0.0% of the time.
  • Page 200 Concurrence of System and Reference (CGM vs. YSI) The percentage of concurring glucose values (CGM vs. YSI) in each glucose reference range is presented for each CGM range in Tables 3a and 3b and for each YSI range in Tables 3c and 3d. For example, in the Adult study, when the System glucose readings were within the 81 to 120 mg/dL range, actual blood glucose values were between 40 and 60 mg/dL 0.2% of the time, between 61 and 80 mg/dL 11.0% of the time, between 81 and 120 mg/dL 70.1% of the time,...
  • Page 201 Table 3a: Concurrence Analysis by CGM Glucose Level (Adult; n=144) YSI Glucose Level (mg/dL) CGM Glucose Level 121- 161- 201- 251- 301- 351- <40 40-60 61-80 81-120 >400 (mg/dL) † <40 20.0 20.0 40.0 20.0 40-60 52.9 43.3 1889 61-80 18.9 62.7 18.1 3090 81-120...
  • Page 202 Table 3b: Concurrence Analysis by CGM Glucose Level (Pediatric*; n=129) YSI Glucose Level (mg/dL) CGM Glucose Level 121- 161- 201- 251- 301- 351- <40 40-60 61-80 81-120 >400 (mg/dL) † <40 50.0 50.0 40-60 48.6 42.5 61-80 12.1 61.9 24.3 81-120 11.2 69.0 18.2 1006...
  • Page 203 Table 3c: Concurrence Analysis by YSI Glucose Level (Adult; n=144) CGM Glucose Level (mg/dL) YSI Glucose Level 121- 161- 201- 251- 301- 351- † † <40 40-60 61-80 81-120 >400 (mg/dL) <40 12.5 87.5 40-60 62.9 36.6 1591 61-80 26.4 62.6 10.8 3093 81-120 18.8 71.7...
  • Page 204 Table 3d: Concurrence Analysis by YSI Glucose Level (Pediatric*; n=129) CGM Glucose Level (mg/dL) YSI Glucose Level 121- 161- 201- 251- 301- 351- † † <40 40-60 61-80 81-120 >400 (mg/dL) <40 100.0 40-60 69.2 30.0 61-80 24.8 62.6 12.5 81-120 21.0 65.7 1057...
  • Page 205 Glucose Rate of Change Accuracy The System’s glucose rate of change accuracy, as assessed by concurrence analysis, is presented in Tables 4a and 4b. For example, in the Adult study, when the Sensor glucose trend arrow indicated that glucose was changing slowly downward (-1 to 0 mg/dL/min ( )), actual glucose levels in the body were falling quickly (<-2 mg/dL/min) 1.2% of the time, falling (-2 to -1 mg/dL/min) 8.3% of the time, changing slowly downward (-1 to 0 mg/dL/min ) 67.1% of the time, changing slowly...
  • Page 206 Table 4b: Concurrence Analysis by Glucose Rate of Change (Pediatric*; n=129) YSI (mg/dL/min) (mg/dL/min) <-2 [-2, -1) [-1, 0) [0, 1] (1, 2] >2 <-2 (i) 44.1 44.7 -2 to -1 (m) 11.4 49.5 32.8 -1 to 0 (g) 11.2 60.0 20.8 2587...
  • Page 207 True Alarm Rate Tells you: When you got a low glucose alarm, were you actually low? Definition: Percentage of time the alarm issued and blood glucose was below the alarm level within 15 minutes before or after the alarm. False Alarm Rate Tells you: Did you get a low glucose alarm that you shouldn’t have? Definition: Percentage of time the alarm issued and blood glucose was not below the alarm level within 15 minutes before or after the alarm.
  • Page 208 Table 5a: Low Glucose Alarm Performance (Adult; n=144) Alarm Rate Detection Rate Low Glucose Alarm level Correct Missed Number of True Alarm False Alarm Number of (mg/dL) Detection Detection Events (n) Rate (%) Rate (%) Events (n) Rate (%) Rate (%) 72.6 27.4 75.7...
  • Page 209 High Glucose Alarm Performance Tables 5c and 5d display the percentages for these parameters: True Alarm Rate Tells you: When you got a high glucose alarm, were you actually high? Definition: Percentage of time the alarm issued and blood glucose was above the alarm level within 15 minutes before or after the alarm.
  • Page 210 For example, the Adult study found that for a High Glucose alarm level set to 200 mg/dL: 99.2% of the time a high glucose alarm was received when blood glucose was indeed above the alarm level but 0.8% of the time a high glucose alarm was received when blood glucose wasn’t actually above the alarm level.
  • Page 211 Table 5d: High Glucose Alarm Performance (Pediatric*; n=129) Alarm Rate Detection Rate High Glucose Alarm level True Alarm False Alarm Correct Missed Number of Number of (mg/dL) Rate Rate Detection Detection Events (n) Events (n) Rate (%) Rate (%) 34176 98.8 4441 98.2...
  • Page 212 Table 6a: Sensor Accuracy Relative to YSI over the wear duration (Adult; n=144) Number of Wear Within ±15% / Within ±20% / Within ±40% / CGM-reference MARD (%) Period ±15 mg/dL ±20 mg/dL ±40 mg/dL pairs Beginning 6955 83.4 90.4 99.3 Early Middle 4522...
  • Page 213 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, 146 Sensors were evaluated in the Adult study and 139 Sensors were evaluated in the Pediatric study to determine how many days of readings each Sensor provided.
  • Page 214 Table 7a: Sensor Survival Rate Over Wear Duration (Adult; n=146) Day of Wear Number of Sensors Survival Rate (%) 99.3 97.3 95.9 93.8 91.8 91.1 90.4 87.0 84.9 82.2 77.3 76.6 71.8 71.1...
  • Page 215 Table 7b: Sensor Survival Rate Over Wear Duration (Pediatric; n=139) Day of Wear Number of Sensors Survival Rate (%) 98.6 97.8 97.1 96.4 96.4 96.4 96.4 94.9 91.3 89.9 88.4 87.0 83.4 78.1...
  • Page 216 Glucose Reading Availability The System is designed to show a Sensor glucose reading after each scan that is performed throughout the wear period after the start-up time. Tables 8a and 8b show the glucose reading capture rate for each day of the wear duration. Table 8a: Glucose Reading Capture Rate Over Wear Duration (Adult;...
  • Page 217 Table 8b: Glucose Reading Capture Rate Over Wear Duration (Pediatric; n=139) Day of Wear Number of Sensors Capture Rate (%) 94.6 94.9 95.2 95.3 95.5 95.6 96.0 95.9 95.7 95.6 95.6 95.8 95.9 95.8...
  • Page 218 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 9a provides data from 146 subjects in the Adult study; Table 9b provides data from 137 subjects in the Pediatric study. For adults, the paired absolute relative difference (PARD) between the two Sensors was 8.1% with coefficient of variation (CV) of 5.7%.
  • Page 219 Adverse Events No device related serious adverse events occurred during the studies. In the Adult study, mild skin irritations, such as erythema, bruising, bleeding, and scabbing were reported around the insertion site and adhesive area by a small number of subjects (10 out of 146 or 6.8%). Pain was mostly reported as none with only one instance of mild pain.
  • Page 220 after the 1000 mg ascorbic acid dose. Subjects then received a second dose of 1000 mg ascorbic acid with a meal and the same process was continued for another 4 hours. A third dose of 1000 mg ascorbic acid was then given and study subjects were followed for 4 more hours. After the second dose of ascorbic acid the maximum average sensor bias increased, with minimal change in sensor bias after the third dose, suggesting that saturation had occurred by the second 1000 mg dose of ascorbic acid.

  • Page 221: Electromagnetic Compatibility (Emc)

    EMC information provided in this manual. • Portable and mobile RF communications equipment can affect the System. • Use of accessories, transducers, and cables other than those specified or provided by Abbott Diabetes Care could result in increased electromagnetic emissions or decreased electromagnetic immunity of the System and result in improper operation.
  • Page 222 Guidance and manufacturer’s declaration – electromagnetic emissions The System is intended for use in the electromagnetic environment specified below. The customer or the user of the System should assure that it is used in such an environment. Electromagnetic Emissions test Compliance environment –...
  • Page 223 Guidance and manufacturer’s declaration – electromagnetic immunity The System is intended for use in the electromagnetic environment specified below. The customer or the user of the System should assure that it is used in such an environment. IMMUNITY IEC 60601 Compliance Electromagnetic test...
  • Page 224 IMMUNITY IEC 60601 Compliance Electromagnetic test test level Level environment – guidance Surge ±1 kV ±1 kV Mains power quality should be that differential differential of a typical domestic, commercial, IEC 61000-4-5 mode mode or hospital environment. ±2 kV common ±2 kV common mode mode...
  • Page 225 IMMUNITY IEC 60601 Compliance Electromagnetic test test level Level environment – guidance Power frequency 30 A/m 30 A/m Power frequency magnetic fields (50/60 Hz) should be at levels characteristic magnetic field of a typical location in a typical domestic, commercial, or hospital IEC 61000-4-8 environment.
  • Page 226 IEC external antennas) should be used 61000-4-3 no closer than 30 cm (12 inches) to any part of the System, including cables specified by Abbott Diabetes Care. Otherwise degradation of the System could result.
  • Page 227 The table below lists the immunity levels at specific test frequencies for testing the effects of some wireless communications equipment. The frequencies and services listed in the table are representative examples in various locations where the System may be used. Test Maximum IMMUNITY...
  • Page 228 Test Maximum IMMUNITY Band Distance frequency Service Modulation power TEST LEVEL (MHz) (MHz) (V/m) 1720 GSM 1800; CDMA 1900; Pulse GSM 1900; 1845 1700 – 1990 modulation DECT; 217 Hz LTE Band 1, 3, 4, 25; UMTS 1970 Bluetooth, WLAN, Pulse 2450 2400 –...
  • Page 229 Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol: 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.
  • Page 230 Font License ©2013 Abbott Licensed under the Apache License, Version 2.0 (the “License”); you may not use this file except in compliance with the License. You may obtain a copy of the License at: http://www.apache.org/licenses/LICENSE-2.0 Unless required by applicable law or agreed to in writing, software distributed under the License is distributed on an “AS IS”...
  • Page 231 DEFINITIONS “Font Software” refers to the set of files released by the Copyright Holder(s) under this license and clearly marked as such. This may include source files, build scripts and documentation. “Reserved Font Name” refers to any names specified as such after the copyright statement(s). “Original Version”...
  • Page 232 5) The Font Software, modified or unmodified, in part or in whole, must be distributed entirely under this license, and must not be distributed under any other license. The requirement for fonts to remain under this license does not apply to any document created using the Font Software. TERMINATION This license becomes null and void if any of the above conditions are not met.

  • Page 233: Limited Warranty

    Limited Warranty We hope that you are happy with your FreeStyle Libre 2 System. Please refer to the User’s Manual before using your System for the first time. Abbott Diabetes Care (“Abbott”) warrants that the FreeStyle Libre 2 Reader (“Reader”) shall be free from defects in material and workmanship for a period of one (1) year from the date of manufacture or one (1) year from the original date of purchase with proof of purchase (whichever is later).
  • Page 234 BE UNINTERRUPTED OR ERROR FREE AND ABBOTT WILL NOT BE LIABLE FOR ANY LOST PROFITS, LOST SAVINGS OR OTHER SPECIAL, PUNITIVE, INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING DIRECTLY OR INDIRECTLY FROM PURCHASE, OPERATION OR USE OF THE READER OR FAILURE OF THE READER TO PERFORM IN ACCORDANCE WITH SPECIFICATIONS.
  • Page 235 References: “FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication” (2010) www.wayback.archive-it.org/7993/20170111013014/http://www.fda.gov/ MedicalDevices/Safety/AlertsandNotices/ucm224025.htm “CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens” (2010) www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html American Diabetes Association, 2019.
  • Page 236 7 Days a Week from 8AM to 8PM Eastern Standard Time www.FreeStyleLibre.com The circular shape of the sensor housing, FreeStyle, Libre, and related brand marks are marks of Abbott. Other trademarks are the property of their respective owners. Patent: www.abbott.com/patents Manufacturer...

Table of Contents