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Abbott Freestyle Libre 3 User Manual
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Abbott Freestyle Libre 3 User Manual

Abbott Freestyle Libre 3 User Manual

Continuous glucose monitoring system
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User's Manual
CONTINUOUS GLUCOSE MONITORING SYSTEM

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Questions and answers

Joe Blanford
June 26, 2025

iPhone system updates and the monitor

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Dana
June 19, 2025

If the nfc gets turned off will my glucose reading go HI

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David Cormier
June 18, 2025

Is there a way to calibrate the freestyle libre three mine is 50 points lower than reality

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Tricia Lawrence
June 12, 2025

Are these nickel free

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Summary of Contents for Abbott Freestyle Libre 3

  • Page 1 User’s Manual CONTINUOUS GLUCOSE MONITORING SYSTEM...
  • Page 2 Your Name _________________________________________________...

  • Page 3: Table Of Contents

    Contents Reader Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Important Safety Information .
  • Page 4 Reviewing Your History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Logbook .
  • Page 5 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83 Reader Does Not Power On .

  • Page 6: Reader Symbols

    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 Notes Add more information to notes Food note Rapid-acting insulin note Time changed on Reader Sound and Vibration ON Sound ON, Vibration OFF Sound OFF, Vibration ON...
  • Page 7 Symbol What It Means Sensor communicating with Reader Sensor not communicating with Reader Blood glucose or ketone test Settings Control solution test result Rapid-acting insulin calculator Details of your suggested insulin dose Estimated rapid-acting insulin remaining in body Low battery Battery charging Sensor too cold Sensor too hot...

  • Page 8: Important Safety Information

    Important Safety Information Compatible Sensors You can use FreeStyle Libre 3 Reader with the below Sensors . The age range, wear duration, and Performance Characteristics vary between Sensors . Please reference the labeling content that applies to your Sensor .
  • Page 9 FreeStyle Libre 3 Plus Sensor users: The FreeStyle Libre 3 Continuous Glucose Monitoring System Reader (“Reader”) when used with a FreeStyle Libre 3 Plus Continuous Glucose Monitoring System Sensor (“Sensor”) is indicated for measuring interstitial fluid glucose levels in people (age 2 and older) with diabetes mellitus, including pregnant women .

  • Page 10: Contraindications

    Contraindications The Sensor must be removed prior to Magnetic Resonance Imaging (MRI) . WARNING: • Do not ignore symptoms that may be due to low or high blood glucose . If you have symptoms that do not match the Sensor glucose reading, or suspect that your reading may be inaccurate, check the reading by conducting a fingerstick test using a blood glucose meter .
  • Page 11 Cautions and Important System Information: What the System has not been evaluated for: • The System has not been evaluated for use with other implanted medical devices such as pacemakers . • The System has not been evaluated for use in persons on dialysis . •...
  • Page 12 When to remove the Sensor: • On rare occasions, you may get inaccurate Sensor glucose readings . If you believe your glucose readings are not correct or are inconsistent with how you feel, perform a blood glucose test on your finger to confirm your glucose and check to make sure your Sensor has not come loose .
  • Page 13 What to know about wearing the Sensor: • Do not use the System in people under the age specified in the Indications for Use . • 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 .
  • Page 14 What to know about the Reader’s Built-in Meter: • The Reader is designed to be used only with FreeStyle Precision blood glucose and blood ketone test strips and MediSense control solution . • The Reader is for use by a single person . It must not be used on more than one person including other family members due to the risk of spreading infection .

  • Page 15: Getting To Know Your System

    . The Reader also has a built-in meter for blood glucose and ketone testing . Note: The Reader only works with FreeStyle Libre 3 Sensors or FreeStyle Libre 3 Plus Sensors and cannot be used with other Sensors .

  • Page 16: Reader Kit

    Reader Kit The Reader Kit includes: • • • FreeStyle Libre 3 Reader Power Adapter Quick Start Guide • • • USB Cable User’s Manual Performance Data Inserts Touchscreen USB Port Used to charge the Reader and connect it to a computer.

  • Page 17: Sensor Kit

    Sensor Kit The Sensor Kit includes: • Sensor Applicator • Product Insert Sensor Applicator Applies the Sensor to your body . The Sensor measures and stores glucose readings when worn on your body . The Sensor has a small, flexible tip that is inserted just under the skin .
  • Page 18 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 Current time set on Battery charge remaining the Reader Sound/Vibration setting Sensor Status Signal Status Information about your...
  • Page 19 The Sensor Glucose Readings screen appears after you touch the View Glucose button on the Home Screen . 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 Add Notes Touch to add notes to the...

  • Page 20: Data Management Software

    Data Management Software To upload data from the Reader, please visit www .FreeStyleLibre .com and learn more about the data management software you can use .

  • Page 21: Setting Up Your Reader For The First Time

    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 .
  • Page 22 Step Action Set the Current Date using the arrows on the Current Date touchscreen . Touch next to continue . June 2022 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 23 Step Action The Reader now displays important information about two key topics to help you use the System: • How to understand the Glucose Trend Arrow included on the Glucose Reading screen . • How to return to the Home Screen from any other screen . An arrow will indicate your recent glucose trend: Rising quickly...

  • Page 24: Using Your Sensor

    Using Your Sensor CAUTION: Intense exercise may cause your Sensor to loosen due to sweat or movement of the Sensor . If your Sensor comes loose, you may get no readings or unreliable readings, which may not match how you feel . Follow the instructions to select an appropriate application site .

  • Page 25: Applying Your Sensor

    Applying Your Sensor Action Step Apply Sensors only on the back of your upper arm . 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 26 Action Step Unscrew the cap from the Sensor Applicator and set the cap aside . CAUTION: • Do NOT use if the Sensor Kit package or Tamper Sensor Applicator appear to be damaged Label or tamper label indicates Sensor Applicator has already been opened . •...
  • Page 27 Action Step Place the Sensor Applicator over the prepared site and push down firmly to apply the Sensor to your body . CAUTION: Do NOT push down on the Sensor Applicator until placed over prepared site to prevent unintended results or injury . Gently pull the Sensor Applicator away from your body .

  • Page 28: Starting Your Sensor

    Starting Your Sensor 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 29 Action Step Hold the Reader so the screen touches 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 New Sensor Starting Up be used to check your glucose after 60 minutes .

  • Page 30: Checking Your Glucose

    Checking Your Glucose Step Action Turn the Reader on by pressing 10:23pm the Home Button or touch Ends in 14 days View Glucose from the Home View Glucose Review History Screen . Start New Sensor The Reader displays your current glucose reading .
  • Page 31 Sensor Glucose Readings Glucose Going Glucose Trend Arrow mmol Current Glucose Target Glucose Range Your Target Glucose Range is 10am 10pm not related to your glucose alarm settings. Notes: • The graph displays glucose readings above 21 mmol/L as 21 mmol/L . For consecutive readings above 21 mmol/L, a line is displayed at 21 mmol/L .
  • Page 32 The Glucose Trend Arrow gives you an indication of the direction your glucose is going . Glucose is rising quickly (more than 0 . 1 mmol/L per minute) Glucose is rising (between 0 .06 and 0 . 1 mmol/L per minute) Glucose is changing slowly (less than 0 .06 mmol/L per minute) Glucose is falling...
  • Page 33 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 2 .2 mmol/L . If HI appears on the Reader, your reading is higher than 27 .8 mmol/L .
  • Page 34 Display What To Do If your glucose is projected to be higher than Glucose Going 13 .9 mmol/L or lower than 3 .9 mmol/L within 15 minutes, you will see a message on the screen . mmol You can touch the message button for more Glucose Going information and set a reminder to check your High...

  • Page 35: Alarms

    Alarms When in range of the Reader, your Sensor automatically communicates with the Reader to give you Low and High Glucose Alarms if you turn them ON . These alarms are turned OFF by default . This section explains how to turn on and set alarms as well as how to use them .
  • Page 36 IMPORTANT: What to know about glucose alarms • The Low and High Glucose Alarms should not be used exclusively to detect low or high glucose conditions . The glucose alarms should always be used along with your current glucose, glucose trend arrow, and glucose graph . •...
  • Page 37 IMPORTANT: How to prevent missed alarms • For you to receive alarms, they must be turned ON and you should ensure that your Reader is within 10 meters (33 ft) of you at all times . The Sensor itself will not issue alarms . •...

  • Page 38: Setting Alarms

    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 View Glucose Review History Settings Start New Sensor Alarms Sound &...
  • Page 39 Step Action Select the alarm you want to turn on and set . Change Alarm Settings Low Glucose Alarm: Notifies you when your Low Glucose Alarm glucose is below the level you set . High Glucose Alarm High Glucose Alarm: Notifies you when your Signal Loss Alarm glucose is above the level you set .
  • Page 40 Alarm How to Set High The High Glucose Alarm is off by default . Glucose Touch the slider to turn the alarm High Glucose Alarm Alarm on . The alarm level is initially set to 13 . 9 mmol/L . You can use the arrows to change this value between mmol/L 6 .
  • Page 41 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...

  • Page 42: Setting Alarm Sounds

    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 . View Glucose Review History Settings Start New Sensor Alarms Sound & Vibration Time &...

  • Page 43: Using Alarms

    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 . Touch Dismiss Alarm or press the Home Button mmol to dismiss the alarm . You will only receive one Dismiss Alarm alarm per low glucose episode .
  • Page 44 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 Glucose Alarms . Signal loss could be caused by the Sensor being too far away from the Reader Dismiss Alarm (over 10 meters (33 ft)) or another issue such as...

  • Page 45: Adding Notes

    Adding Notes Notes can be saved with your glucose readings to help you track things like food, insulin, and exercise . Step Action From the Glucose Reading screen, add notes Glucose Going by touching the symbol in the upper right corner of the touchscreen .
  • Page 46 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 Insulin it to add more specific information to Enter Rapid-Acting Insulin Food your note .

  • Page 47: Reviewing Your History

    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 the Reader .
  • Page 48 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 .

  • Page 49: Logbook

    The Logbook and Daily Graph show detailed information, while other history options show summaries of information over a number of days . Logbook The Logbook contains entries for notes you added Logbook as well as each time you received a Low or High 23 Feb 10:23am Glucose Alarm .

  • Page 50: Daily Graph

    Daily Graph A graph of your Sensor glucose readings by day . Daily Graph (mmol/L) The graph shows your Target Glucose Range and symbols for food or rapid-acting insulin notes you have entered . Notes: 22 Feb • Wednesday The graph displays glucose readings up to 21 mmol/L .

  • Page 51: Other History Options

    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: mmol/L is displayed above the graph . The average is also shown for four different 6-hour periods of the day .
  • Page 52 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 4.4 - 7.8 mmol/L Last 7 Days Time In Target Information about the number of low glucose Low Glucose Events...

  • Page 53: 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 54: 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 the Reader reports a problem with the Sensor currently in use .

  • Page 55: 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 56 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 57: Using The Built-In Meter

    Using the Built-in Meter The Reader has a built-in meter that can be used to test your blood glucose and blood ketone, or to test the meter and strips with control solution . WARNING: Do NOT use the built-in meter while the Reader is connected to an electrical outlet or a computer .
  • Page 58 IMPORTANT: • Use the Reader within the test strip operating temperature range as blood glucose and ketone results obtained outside the range may be less accurate . • Use only FreeStyle Precision test strips . • Use a test strip immediately after removing from its foil packet .

  • Page 59: 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 . You can perform a blood glucose test on your fingertip or approved alternate site . Be sure to read the test strip instructions for use prior to using the built-in meter .
  • Page 60 Step Action Check the test strip expiration date . 13758 2030/03 E .g . Expiration date: March 31, 2030 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 61 Step Action You will see a butterfly on the screen while you wait for your result . If sounds are turned on, the Reader beeps once when your result is ready . After reviewing your result, remove and discard the used test strip according to test strip instructions for use .
  • Page 62 Display What To Do If LO appears on the Reader, your result is lower Low Glucose than 1 . 1 mmol/L . If HI appears on the Reader, your result is higher than 27 .8 mmol/L . You can touch the mmol message button for more information .

  • Page 63: Blood Ketone Testing

    After you get your blood glucose result, you can add Notes by touching symbol . If you do not want to add a Note, press the Home Button to go to the Home Screen or hold the Home Button to turn the Reader off . Blood Ketone Testing You can use the built-in meter to check your blood ketone (β-hydroxybutyrate) .
  • Page 64 Step Action Check the test strip expiration date . 13758 2030/03 E .g . Expiration date: March 31, 2030 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 65 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 . If sounds are turned on, the Reader beeps once Ketone Test to let you know you have applied enough blood . Note: See test strip instructions for use for re-application instructions .
  • Page 66 Your Blood Ketone Results 10:23pm Blood ketone results are marked on the results screen and in the Logbook with the word Ketone . mmol Ketone Test Notes: • Blood ketone is expected to be lower than 0 .6 mmol/L . •...
  • Page 67 Display What To Do If your blood ketone is high, you will see a High Ketone message on the screen . You can touch the message button for more information . mmol Ketone Test If HI appears on the Reader, your ketone result is High Ketone higher than 8 mmol/L .

  • Page 68: Control Solution Testing

    Control Solution Testing You should do a control solution test when you are not sure of your test strip results and want to check that your Reader and test strips are working properly . You can do a control solution test with a blood glucose or ketone test strip .
  • Page 69 Action Step From the Home Screen, touch the Settings 10:23pm Ends in 14 days symbol . Scroll down using the arrow and View Glucose touch Control Solution Test . Review History Start New Sensor Reminders Control Solution Test Language 2 / 4 Check the test strip expiration date .
  • Page 70 Action Step Insert the test strip with the three black lines facing up . Push the strip until it stops . Shake the control solution bottle to mix the Apply Control Solution solution . Apply a drop of control solution to the white area at the end of the test strip .
  • Page 71 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 mmol in this range . Control solution results are marked on Control Solution Test the results screen and in the Logbook with a symbol .

  • Page 72: Using The Rapid-Acting Insulin Calculator

    Using the Rapid-Acting Insulin Calculator This optional feature requires an understanding of the use of insulin . Misuse or misunderstanding of this feature and the suggested dose may lead to inappropriate insulin dosing . The calculator suggests doses for rapid-acting insulin only . The calculator is only for use with fingerstick blood glucose results from the built-in meter .
  • Page 73 CAUTION: The rapid-acting insulin calculator cannot account for all the factors that may affect your insulin dose . These include incorrectly entered data, incorrectly set date or time, un-logged insulin, smaller or larger meals, sickness, exercise, etc . It is important that you review your suggested dose and account for these factors before taking insulin .
  • Page 74 Step Action Enter information about any Have you forgotten to log any rapid-acting rapid-acting insulin you may have insulin you have taken since X:XX? forgotten to log . Touch next . Enter any rapid- acting insulin you have forgotten to log. units How long ago was back...
  • Page 75 Step Action If your calculator was programmed with Easy Breakfast Setup, touch the meal you plan to eat now . Touch Lunch next . Dinner No meal back next If your calculator was programmed with Enter Carbs Advanced Setup, enter the grams of carbohydrates or servings of carbohydrates you plan to eat now .
  • Page 76 Step Action Review your suggested dose . If needed, use the Suggested Dose arrow buttons to adjust your suggested dose for Adjust if needed any planned activity, a smaller or larger meal, sickness, etc . Touch the symbol to see details User change: of what is included in your suggested dose .
  • Page 77 Step Action Touch log dose to save to your Logbook and take your dose . Your dose is only saved to the Logbook if you touch log dose . CAUTION: It is important to log all your rapid-acting insulin doses so your Reader can account for active insulin when calculating your suggested doses .
  • Page 78 If your health care professional turned on the Active 10:23pm Ends in 14 days Insulin feature, the symbol may appear on your Home Screen . It shows an estimate of the amount of View Glucose rapid-acting insulin left in your body and how much Review History longer it may be active .

  • Page 79: Charging The Reader

    Charging the Reader A fully charged Reader battery should last up to 4 days . Your battery life may vary depending on your usage . A Low Battery message accompanies your result when you have enough charge remaining for Low Battery about one day of use .
  • Page 80 Notes: • 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 81: Changing The Reader Settings

    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 report settings . The Settings menu is also where you go to do a control solution test or to check the System status .
  • Page 82 Action Step Reminders – See Using Reminders section for information on setting reminders (cont.) Control Solution Test – Perform a control solution test Language – Change the language on the Reader (option only available on Readers with multiple languages) System Status – Check Reader information and performance •...
  • Page 83 Action Step • Perform a Reader Test: The Reader Test will perform internal diagnostics and allow you to check that the (cont.) display is showing all pixels, sounds and vibrations are working, and the Touchscreen is responding when touched Report Settings – Work with your health care professional to set your Target Glucose Range, which is displayed on glucose graphs on the Reader and used to calculate your Time In Target .

  • Page 84: Living With Your System

    Living With Your System Activities 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 .
  • Page 85 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 . • Some airport full-body scanners include x-ray or millimeter radio-wave, which you cannot expose your Sensor to .

  • Page 86: Cleaning

    Activity What You Need To Know Traveling by Air symbol may appear on your glucose (cont.) graph indicating the Reader time was changed . Gaps in the graph may result or glucose readings may be hidden . Cleaning You may clean the Reader as often as desired using a cloth dampened with a mixture of 1 part household bleach to 9 parts water .

  • Page 87: Disposal

    Disposal Reader, Sensor, USB Cable, and Power Adapter: These devices must not be disposed of via municipal waste collection . Separate collection for electrical and electronic equipment waste per Directive 2012/19/EU in the European Union is required . Contact the manufacturer for details .

  • Page 88: Troubleshooting

    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...

  • Page 89: 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 . not sticking of dirt, oil, hair, or 2 . Clean the site with a plain to your skin .

  • Page 90: Problems Starting Your Sensor Or Receiving Sensor

    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 so the screen Timeout...
  • Page 91 Display What It May Mean What To Do Scan Error The Reader Try scanning again . was unable to Note: You may need to move communicate with away from potential sources of the Sensor . electromagnetic interference . Sensor Error The System is Check again in 10 minutes .
  • Page 92 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 . Check your glucose with the device that started it . Or, apply and start a new Sensor .

  • Page 93: Problems Receiving Glucose Alarms

    Problems Receiving Glucose Alarms Problem What It May Mean What To Do You are not You have not turned Touch the Settings symbol and then select Alarms . receiving alarms on . glucose alarms . The Sensor is not The Sensor must be within communicating with range (10 meters (33 ft)) of the Reader for you to receive alarms .
  • Page 94 Problem What It May Mean What To Do You are not Sound/vibration are Check the Reader’s sound and receiving turned off . vibration settings to confirm glucose sound/vibration are on . alarms . (cont.) You may have set an Confirm your alarm settings are alarm level that is appropriate .

  • Page 95: Blood Glucose Or Ketone Error Messages

    Blood Glucose or Ketone 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 96 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 .
  • Page 97 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 .
  • Page 98 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 99: Problems Checking Your Blood Glucose Or Ketone

    Problems Checking Your Blood Glucose or Ketone 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 100 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 .

  • Page 101: Perform A Reader Test

    Perform a Reader Test If you think the Reader is not working properly, you can System Status check the Reader by performing a Reader Test . Touch System Info the Settings symbol from the Home Screen, select Reader Test System Status and then select Reader Test . Event Log Note: The Reader Test will perform internal diagnostics and will allow you to check that the display, sounds, and...

  • Page 102: Professional Options

    Professional Options This section is only meant for health care professionals . It describes the access code-protected features of the Reader . Health care professionals can change dose increments or set up the insulin calculator . From the Home Screen, touch the Settings symbol .

  • Page 103: Changing Dose Increments

    Changing Dose Increments You can set the insulin dose increments to either 1 .0 or 0 .5 units for use with the Rapid-acting insulin calculator and insulin notes . From the Professional Options screen, select Dose Increment Dose Increment . Then choose 1 unit or 0.5 unit . 1 unit Touch done .

  • Page 104: Setting Up The Insulin Calculator

    Setting up the Insulin Calculator The insulin calculator can help your patients calculate their rapid-acting insulin doses based on meal and fingerstick blood glucose level information . From the Professional Options screen, select Insulin Calculator . CAUTION: This feature requires an understanding of the use of insulin .
  • Page 105 You can set up the insulin calculator using the Easy or Advanced settings . The Easy Setup is for patients who start with a fixed dose of rapid-acting insulin for meals . The Advanced Setup is for patients who count carbohydrates (in grams or servings) to adjust their rapid-acting insulin dose for meals .

  • Page 106: Easy Setup Of The Insulin Calculator

    Easy Setup of the Insulin Calculator Action Step Choose the Easy option on the slide bar and Choose Setup Option touch next . Easy Note: You need to know your patient’s For patients who start with a fixed dose of rapid-acting meal-time insulin doses, target glucose range, insulin at meals.
  • Page 107 Action Step Enter the Correction Factor (for example: if 1 unit Correction Factor of insulin lowers blood glucose 2 . 8 mmol/L, then 1 u insulin for the correction factor is 2 .8) . If the blood glucose mmol value is outside the blood glucose target, the calculator will use the correction target and factor to calculate a correction dose .
  • Page 108 Notes about the Easy Option: • The calculator estimates the amount of rapid-acting insulin still in the body and how much longer it may be active (if the correction factor is set to “no correction insulin”, active insulin is not calculated) . The active insulin estimate is based on a 4-hour insulin duration calculated from the time and amount of the last logged rapid-acting insulin dose .
  • Page 109 Calculator Settings - Easy Option This page can be used to record insulin calculator settings . This is the insulin Breakfast Lunch Dinner Dose Dose Dose required to cover food . units of insulin units of insulin units of insulin 0-50 0-50 0-50...

  • Page 110: Advanced Setup Of The Insulin Calculator

    Advanced Setup of the Insulin Calculator Action Step Choose the Advanced option on the slide bar Choose Setup Option and touch next . Advanced Note: You need to know your patient’s meal- For patients who count carbs (in grams or servings) to adjust time insulin settings, target glucose range, their rapid-acting insulin dose at meals.
  • Page 111 Action Step If you chose to enter Grams of carbs in Step 2: Carbohydrate Ratio The rapid-acting insulin dose suggestion is based 1 u insulin for on grams of carbs . grams carbs Enter the Carbohydrate Ratio (1 unit of rapid- by time Optional: of day...
  • Page 112 Action Step If you chose to enter Servings in Step 2: The Servings Definition rapid-acting insulin dose suggestion is based on 1 serving = servings . grams carbs Enter the Servings Definition (10 to 15 grams of carbs) and touch next . Enter the Servings Ratio back next...
  • Page 113 Action Step Select how you want your patient to correct their How does your patient correct their glucose . Touch next glucose? To a single target To a target range back next Enter the Correction Target value or range . This Correction Target is the desired target value or range for blood glucose values before meals .
  • Page 114 Action Step Enter the Correction Factor (for example: if 1 Correction Factor unit of insulin lowers blood glucose 2 .8 mmol/L, 1 u insulin for then the correction factor is 2 .8) . If the blood mmol glucose reading is outside the blood glucose by time Optional: of day...
  • Page 115 Action Step Enter the Insulin Duration . This is the amount of Insulin Duration time that rapid-acting insulin remains active in 4:30 the patient’s body . hrs:min Touch next . back next IMPORTANT: In general, the insulin duration for rapid- acting insulin ranges from 3-5 hours, and can vary for each person .
  • Page 116 Action Step Select whether or not to show the Active Insulin Do you want the Active Insulin symbol symbol on the Home Screen . to be displayed on the Home Screen? This symbol shows an estimate of the amount of rapid-acting insulin still in the body and how much longer it may be active .
  • Page 117 Notes about the Advanced Option: • The calculator estimates the amount of rapid-acting insulin still in the body and how much longer it may be active . The active insulin estimate is calculated from the set insulin duration, the time, and amount of the last logged rapid-acting insulin dose .
  • Page 118 This graph shows how the insulin calculator estimates the amount of active insulin as a function of logged insulin dose and insulin duration over time . It also shows the relationship between the symbol and amount of active insulin . Active insulin curvilinear model % insulin duration Adapted from Mudaliar et al .
  • Page 119 Calculator Settings - Advanced Option This page can be used to record insulin calculator settings . This is the number of grams of Carbohydrate carbs that one unit of rapid-acting Ratio 1 unit of insulin for insulin will cover OR the number of units of rapid-acting insulin that will cover one serving .
  • Page 120 This is the estimated amount blood Correction Factor glucose will drop by taking one unit 1 unit of insulin for of insulin . (Option to enter by time of day .) mmol/L 0.1-5.5 Insulin Duration This is the amount of time that a dose Insulin is active in the body for of rapid-acting insulin remains active in the body .

  • Page 121: Changing The Insulin Calculator Settings

    Changing the Insulin Calculator Settings Action Step From the Home Screen, touch the Settings symbol . Scroll down using the arrows and Reader Basics touch Professional Options . Enter the access Professional Options code . Touch Insulin Calculator . 4 / 4 Touch Turn Off Calculator to turn off the insulin Calculator Settings calculator or Change Calculator Settings to...

  • Page 122: System Specifications

    2 .9 mm height and 21 mm diameter Sensor weight 1 gram Sensor power source One silver oxide battery FreeStyle Libre 3 Sensor: Up to 14 days Sensor life FreeStyle Libre 3 Plus Sensor: Up to 15 days FreeStyle Libre 3 Sensor: Up to 14...
  • Page 123 Sensor transmission 10 meters (33 ft) unobstructed range Operating temperature 10°C to 45°C Sensor Applicator 2°C to 28°C storage temperature Operating and storage 10-90%, non-condensing relative humidity IP27: Can withstand immersion into Sensor water resistance one meter (3 ft) of water for up to 30 and ingress protection minutes .

  • Page 124: Reader Specifications

    Reader Specifications Blood glucose assay 1 .1 to 27 .8 mmol/L range Blood ketone assay range 0 .0 to 8 .0 mmol/L 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...
  • Page 125 System must only be used with Requirements EN60950-1 rated computers Mean service life 3 years of typical use Abbott Diabetes Care PRT31940 Power Adapter Operating temperature: 10°C to 40°C Abbott Diabetes Care PRT21373 USB Cable Length: 94 cm (37 inches)

  • Page 126: Rapid-Acting Insulin Calculator Specifications

    Rapid-Acting Insulin Calculator Specifications Parameter Unit Range or Value Correction target mmol/L 3 . 9 to 10 . 0 1 unit per X grams Carbohydrate ratio 1 to 50 of carbs Units of insulin per Servings ratio 0 . 5 to 15 serving Servings definition Grams of carbs...

  • Page 127: Labeling Symbols

    Labeling Symbols Consult instructions for use or consult electronic Use-by date instructions for use Temperature limit Catalog number Manufacturer Date of Manufacture CE Mark Serial number Sterilized using irradiation Keep dry Batch code Importer Type BF applied part Caution Do not re-use Humidity limitation Medical Device Non-ionizing radiation...
  • Page 128 Patient information website Single sterile barrier system with protective packaging outside Authorized Representative in the European Community/European Union Sterile Barrier . Refer to Instructions for Use if opened or damaged . Do not use if package is damaged . For Sterile Barrier: Do not use if the product sterile barrier system or its packaging is compromised .

  • Page 129: Electromagnetic Compatibility

    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 130: Guidance And Manufacturer's Declaration - Electromagnetic Emissions

    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 131: Guidance And Manufacturer's Declaration - Electromagnetic Immunity

    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 132 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 133 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 134 30 cm (12 inches) to any part of the System, including cables specified by Abbott Diabetes Care. Radiated RF 10 V/m 10 V/m Otherwise, degradation of the...
  • Page 135 The table below lists the immunity test 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 healthcare and in various locations where the System may be used. IMMUNITY Test Band...
  • Page 136 IMMUNITY Test Band Maximum Distance TEST frequency Service Modulation (MHz) power (W) LEVEL (MHz) (V/m) 1720 1700 – 1990 GSM 1800; Pulse CDMA 1900; modulation GSM 1900; 217 Hz 1845 DECT; LTE Band 1, 3, 4, 25; UMTS 1970 2450 2400 –...
  • Page 137 Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m. Hereby, Abbott Diabetes Care Ltd., declares that the radio equipment type FreeStyle Libre 3 Reader is in compliance with Directive 2014/53/EU. The full text of the EU declaration of conformity is available...
  • Page 138 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 139 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 140 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 141 European Union: Abbott GmbH Max-Planck-Ring 2 65205 Wiesbaden Germany The sensor housing, FreeStyle, Libre, and related brand marks are marks of Abbott. Other trademarks are the property of their respective owners. Patent: https://www.abbott.com/patents ©2024 Abbott ART50033-010 Rev. A 07/24...

This manual is also suitable for:

Freestyle libre 3 plus