Фристайл либре инструкция по применению на русском

Простые шаги на пути к использованию датчика

Готовы ли вы получать полную картину изменения уровня глюкозы днем и ночью с помощью новой системы FreeStyle Libre?  Если да, позвольте помочь вам получить максимум пользы.

Выбор места установки датчика

Датчик является основным элементом для получения полной картины изменения уровня глюкозы, поэтому не забывайте выбирать правильное место установки датчика, а установку проводите с осторожностью:

Установка датчика

После подготовки кожи можно приступить к установке датчика. Футляр датчика и аппликатор упакованы в один комплект (отдельно от сканера).

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  User’s Manual FLASH GLUCOSE MONITORING SYSTEM CAUTION: Federal law restricts this device to sale by or on the order of a physician.
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  Your Name _________________________________________________…
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  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.
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  Contents Important Safety Information……1 Indications For Use ……..1 Compatible Devices, Apps, and Software .
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  Alarms……….56 Setting Alarms .
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  Living With Your System……. . 99 Maintenance and Disposal ……102 Troubleshooting .
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  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.
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  Compatible Devices, Apps, and Software For a list of compatible devices, apps, and software that can be used with the FreeStyle Libre 2 Sensor, please go to: https://freestylelibre.us/support/overview.html Use of the Sensor with devices, apps, and software that are not listed may cause inaccurate glucose readings.
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  WARNINGS: • Do not ignore symptoms that may be due to low or high blood glucose: If you are experiencing symptoms that are not consistent with your glucose readings, consult your health care professional. • Use your blood glucose meter to make diabetes treatment decisions when you see the symbol during the first 12 hours of wearing a Sensor, if your Sensor glucose reading does not match how you feel,…
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  • To prevent missed alarms, make sure the Reader has sufficient charge and that sound and/or vibration are turned on. • Alarms you receive do not include your glucose reading so you must scan your Sensor to check your glucose. What to know before using the System: •…
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  What should you know about wearing a Sensor: • Wash application site on the back of your upper arm using a plain soap, dry, and then clean with an alcohol wipe. This will help remove any oily residue that may prevent the Sensor from sticking properly. Allow site to air dry before proceeding.
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  performing as intended. Contact Customer Service if you receive a Replace Sensor message before the end of the 14 day wear period. Customer Service is available at 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Standard Time. • Some individuals may be sensitive to the adhesive that keeps the Sensor attached to the skin.
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  • 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: •…
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  • Do NOT use if Sensor Kit contents are past expiration date. • Do NOT use if the Reader appears to be damaged due to risk of electric shock and/or no results. What to know before you Apply the Sensor: •…
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  • Clean hands prior to Sensor handling/insertion to help prevent infection. • Change the application site for the next Sensor application to prevent discomfort or skin irritation. • Only apply the Sensor to the back of the upper arm. If placed in other areas, the Sensor may not function properly.
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  What to know about X-Rays: • The Sensor should be removed prior to exposing it to an X-ray machine. The effect of X-rays on the performance of the System has not been evaluated. The exposure may damage the Sensor and may impact proper function of the device to detect trends and track patterns in glucose values during the wear period.
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  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.
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  Interfering Substances Taking ascorbic acid (vitamin C) supplements while wearing the Sensor may falsely raise Sensor glucose readings. Taking more than 500 mg of ascorbic acid per day may affect the Sensor readings which could cause you to miss a severe low glucose event. Ascorbic acid can be found in supplements including multivitamins.
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  Reader Symbols Symbol What It Means Active Sensor Direction your glucose is going. See Checking Your Glucose section for more information. Caution View previous/next screen Sound and Vibration ON Sound ON, Vibration OFF Sound OFF, Vibration ON Sound and Vibration OFF Sensor communicating with Reader Sensor not communicating with Reader…
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  Symbol What It Means When you see this symbol during the first 12 hours of wearing a Sensor, confirm Sensor glucose readings with a blood glucose test before making treatment decisions. Notes Add more information to notes Food note Rapid-acting insulin note Time changed on Reader Blood glucose test Settings…
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  Getting to Know Your System The FreeStyle Libre 2 System (“System”) has two main parts: a handheld Reader and a disposable Sensor that you wear on your body. You use the Reader to wirelessly scan the Sensor and display your glucose readings.
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  IMPORTANT: • Before you use your 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.
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  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).
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  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 measures and stores glucose readings when worn on your body.
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  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. Home Screen Battery charge remaining Sound/Vibration setting Current time set on the Reader Signal Status Shows if Sensor is communicating with Reader.
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  The Sensor Glucose Readings screen appears after you use the Reader to scan your Sensor. Your Reading 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. Sensor Glucose Readings Message Add Notes…
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  Sensor glucose readings, blood glucose test results, and other data uploaded from the FreeStyle Libre 2 Flash Glucose Monitoring System, in support of an effective diabetes health management program. FreeStyle Libre software is not intended for the diagnosis of or screening for diabetes mellitus.
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  Setting up Your Reader for the First Time Before using the System for the first time, the Reader must be set up. Step Action Press the Home Button to turn on the Reader. If prompted, use the touchscreen to select your preferred language for the Reader.
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  Step Action Set the Current Date using the arrows on the Current Date touchscreen. Touch next to continue. June 2020 back next Set the Current Time. Touch next to continue. Current Time CAUTION: It is very important to set the time and date correctly.
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  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.
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  Using Your Sensor CAUTIONS: • The Sensor Pack and Sensor Applicator FreeStyle Libre Sensor Pack are packaged as a set (separately from the Reader) and have the same Sensor CODE code. Check that the Sensor codes match XXXXXXXXX before using your Sensor Pack and Sensor YYYY-MM-DD Applicator.
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  Applying Your Sensor 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).
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  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.
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  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.
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  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.
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  Starting Your Sensor Action Step Press the Home Button to turn on the Reader. Touch Start New Sensor. 10:23pm No Active Sensor Start New Review Sensor History 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.
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  Checking Your Glucose 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.
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  Step Action The Reader displays your current glucose reading along with your glucose graph and an arrow Glucose Going High indicating the direction your glucose is going. 10am…
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  Sensor Glucose Readings Glucose Going Glucose Trend Arrow Current Glucose Target Glucose Range Your Target Glucose Range 10pm is not related to your glucose alarm settings. Notes: • The graph displays glucose readings above 350 mg/dL at 350 mg/dL. For sequential readings above 350 mg/dL, a line is displayed at 350 mg/dL.
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  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…
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  The following table shows messages you may see with your glucose readings. Display What To Do If LO appears on the Reader, your reading is lower Low Glucose than 40 mg/dL. If HI appears on the Reader, your reading is higher than 400 mg/dL. You can touch the message button for more information.
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  Display What To Do If your glucose is projected to be higher than Glucose Going 240 mg/dL or lower than 70 mg/dL within 15 minutes, you will see a message on the screen. You can touch the message button for more Glucose Going information and set a reminder to check your High…
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  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.
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  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.
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  • 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. •…
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  • Sensor glucose values, which are based on interstitial fluid glucose levels, can be different from blood glucose levels (fingersticks), particularly during times when your blood glucose is changing quickly. If your glucose readings and alarms from the System do not match your symptoms or expectations, use a fingerstick blood glucose value from a blood glucose meter to make diabetes treatment decisions.
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  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.
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  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.
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  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. Glucose Trend Arrow Direction your glucose is going Current Glucose Arrow What it means…
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  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…
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  Treatment Decision Considerations Glucose Trend Low Glucose Glucose in High Glucose Arrow (< 70 mg/dL) Target Range (> 240 mg/dL) If you are about to eat, Treat low glucose If you are about to eat, according to your health take insulin to cover take insulin to cover care professional’s your meal.
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  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.
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  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.
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  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.
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  Example Scenarios Next 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.
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  What you see What it means Before breakfast: Before breakfast, your current glucose is 115 mg/dL. The graph shows that your glucose 8:06am Ends in 2 days 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.
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  What you see What it means Before lunch: When you checked your glucose before lunch, it was 90 mg/dL and rising. Before eating lunch, 12:00pm Ends in 3 days you took enough insulin to cover the meal and a little more since your trend arrow was 12pm After lunch: 90 minutes later, your current glucose is…
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  What you see What it means In the afternoon: Between meals, your current glucose is 72 mg/dL. The Glucose Going Low message Glucose Going tells you that your glucose is projected to be low within 15 minutes. Think about what might be causing your glucose to go low.
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  What you see What it means Before dinner: Before dinner, your current glucose is 134 mg/dL. The graph shows that your glucose 7:34pm Ends in 7 days 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.
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  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 •…
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  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? •…
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  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. This section explains how to set and use alarms as well as how to turn them off.
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  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.
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  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. •…
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  Setting 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 &…
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  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.
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  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…
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  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…
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  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.
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  Setting 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 &…
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  Using 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 &…
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  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.
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  Adding Notes Notes can be saved with your glucose readings. You can add a note at the time of your glucose reading or within 15 minutes after your reading was obtained. You can track food, insulin, exercise, and any medication you take.
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  Step Action After you check the box for food and Add Notes insulin notes, the symbol appears Rapid-Acting Insulin to the right of the note. You can touch Long-Acting it to add more specific information to Insulin Enter Rapid-Acting Insulin Food your note.
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  Reviewing Your History Reviewing and understanding your glucose history can be an important tool for improving your glucose control. The Reader stores about 90 days of information and has several ways to review your past glucose readings, notes, and other information. Step Action Press the Home Button to turn on…
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  Step Action 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 IMPORTANT: Work with your health care professional to understand your glucose history.
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  The Logbook and Daily Graph show detailed information, while other history options show summaries of information over a number of days. 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…
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  Daily Graph 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. Notes: • 22 Feb While Sensor glucose readings are gathered in Wednesday the System range of 40-400 mg/dL, the Daily Graph display range is 0-350 mg/dL for ease…
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  Other History Options Use the arrows to view information about your last 7, 14, 30, or 90 days. 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.
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  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.
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  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.
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  Replacing Your Sensor Your Sensor automatically stops working after 14 days of wear and must be replaced. You should also replace your Sensor if you notice any irritation or discomfort at the application site or if the Reader reports a problem with the Sensor currently in use.
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  Using Reminders You can use 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 disabled your alarms temporarily. Step Action From the Home Screen, touch the Settings 10:23pm…
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  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.
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  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.
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  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. •…
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  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.
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  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. •…
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  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.
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  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.
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  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.
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  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.
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  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.
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  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.
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  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.
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  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.
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  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.
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  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.
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  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.
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  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.
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  Charging the Reader A fully charged Reader battery should last up to 4 days. Your battery life may vary depending on your usage. A Low Battery message Low Battery accompanies your result when you have enough charge remaining for about one day of use. Please charge the Reader to continue using it.
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  Changing the Reader Settings 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.
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  Action Step Touch the setting you want to change: Alarms – See 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 –…
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  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 Report Settings –…
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  Living With Your System Your System can be used during a wide variety of 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.
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  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. • The Reader is classed as a Medical-Portable Electronic Device (M-PED) that meets all required M-PED emission standards for safe use onboard an aircraft: RTCA/DO160, Section 21, Category M.
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  Activity What You Need To Know Traveling by Air • The System can be exposed to common electrostatic (ESD) and electromagnetic (cont.) interference (EMI), including airport metal detectors. You can keep your Reader on while going through these. Note: If you are changing time zones, you can change the time and date settings on the Reader by touching the Settings symbol from the…
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  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).
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  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.
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  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.
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  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.
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  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.
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  Troubleshooting This section lists problems or observations that you may have, the possible cause(s), and recommended actions. If the Reader experiences an error, a message will appear on the screen with directions to resolve the error. Reader Does Not Power On Problem What It May Mean What To Do…
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  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.
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  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 60 minute Sensor Starting Up to read glucose. start-up period has completed. Scan The Reader is not Hold the Reader within Timeout held close enough…
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  Display What It May Mean What To Do Signal Loss Sensor has not Make sure the Reader is within Alarm automatically 20 feet of the Sensor. Try communicated with scanning the Sensor to get a the Reader in the glucose reading. If the Signal last 20 minutes.
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  Display What It May Mean What To Do Sensor Error The System is Scan again after the duration unable to provide a specified in the message. glucose reading. Note: If you receive this error during your first 12 hours of wearing a Sensor, it may mean that your body is still adjusting to the Sensor.
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  Display What It May Mean What To Do Sensor The Sensor was Your Reader can only be used Already in started by another with a Sensor that it started. device. Scan the Sensor again with the device that started it. Or, apply and start a new Sensor.
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  Problems Receiving Glucose Alarms Problem What It May Mean What To Do You are not You have turned Touch the Settings symbol and then select Alarms. receiving alarms off. glucose alarms. The Sensor is not The Sensor must be within range (20 feet) of the Reader for you to communicating with receive alarms.
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  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 of when a new low or high glucose alarm.
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  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.
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  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.
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  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.
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  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).
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  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.
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  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.
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  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.
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  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…
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  Sensor data Up to 14 days 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…
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  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…
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  Reader moisture Keep dry protection Operating and storage -1,250 ft (-381 meters) to 10,000 ft altitude (3,048 meters) 60 seconds (120 seconds when test Reader display timeout strip is inserted) Near Field Communication (13.56 MHz RFID); ASK Modulation; 124 dBuV/m; Radio Frequency 1.5 inch communication range 2.402-2.480 GHz BLE;…
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  Reader that activated the 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.
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  20 minutes, the Reader alarms the user if the alarm is turned on. If connection is lost between the Sensor and the Reader, up to 8 hours of glucose results can be retrieved by performing a scan with the Reader. The Reader is designed to only accept radio frequency (RF) communications from recognized and paired Sensors.
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  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…
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  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.
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  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).
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  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).
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  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…
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  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)
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  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)
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  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)
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  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)
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  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’…
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  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.
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  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,…
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  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…
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  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…
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  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…
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  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…
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  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…
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  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…
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  False Alarm Rate Tells you: Did you get a low glucose alarm that you shouldn’t have? Definition: Percentage of time the alarm issued and blood glucose was not below the alarm level within 15 minutes before or after the alarm. Detection Rate Tells you: When you were low, did you get a low glucose alarm? Definition: Percentage of time blood glucose was below the alarm level and the alarm issued within…
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  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…
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  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.
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  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.
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  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…
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  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…
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  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.
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  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…
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  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…
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  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;…
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  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…
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  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%.
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  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.
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  EMC information provided in this manual. • Portable and mobile RF communications equipment can affect the System. • 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 System.
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  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 –…
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  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…
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  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 169
  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.
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  IMMUNITY IEC 60601 Compliance Electromagnetic test test level Level environment – guidance Conducted RF 6 Vrms 6 Vrms Portable and mobile RF communications equipment should IEC 61000-4-6 150 kHz to be used no closer to any part of the 80 MHz System, including cables, than the recommended separation distance calculated from the equation…
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  IMMUNITY IEC 60601 Compliance Electromagnetic test test level Level environment – guidance Recommended separation Radiated RF 10 V/m 10 V/m distance IEC 61000-4-3 80 MHz to 2.7 GHz 80 MHz to 800 MHz 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).
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  Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the System is used exceeds the applicable RF compliance level above, the System should be observed to verify normal operation.
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  Recommended separation distances between portable and mobile RF communications equipment and the System The System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the System as recommended below, according to the maximum output power of the communications equipment.
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  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”…
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  PREAMBLE The goals of the Open Font License (OFL) are to stimulate worldwide development of collaborative font projects, to support the font creation efforts of academic and linguistic communities, and to provide a free and open framework in which fonts may be shared and improved in partnership with others. The OFL allows the licensed fonts to be used, studied, modified and redistributed freely as long as they are not sold by themselves.
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  2) Original or Modified Versions of the Font Software may be bundled, redistributed and/or sold with any software, provided that each copy contains the above copyright notice and this license. These can be included either as stand-alone text files, human-readable headers or in the appropriate machine-readable metadata fields within text or binary files as long as those fields can be easily viewed by the user.
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  Limited Warranty We hope that you are happy with your FreeStyle Libre 2 system. Please refer to the User’s Manual before using your Reader for the first time. Abbott Diabetes Care (“Abbott”) warrants that the FreeStyle Libre 2 reader (“Reader”)
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  PURPOSE. ABBOTT DOES NOT WARRANT THAT OPERATION OF THE READER WILL BE UNINTERRUPTED OR ERROR FREE AND ABBOTT WILL NOT BE LIABLE FOR ANY LOST PROFITS, LOST SAVINGS OR OTHER SPECIAL, PUNITIVE, INCIDENTAL 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 179
  References: “FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication” (2010) http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025. “CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens” (2010) http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html American Diabetes Association, 2019.
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  7 Days a Week from 8AM to 8PM Eastern Standard Time www.FreeStyleLibre.com The shape of the circle sensor unit, FreeStyle, Libre, and related brand marks are owned by Abbott. Other trademarks are the property of their respective owners. Patent: https://www.abbott.com/patents Manufacturer…