Abbott FreeStyle Libre 2 Manual
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Abbott FreeStyle Libre 2 Manual

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4.6"
Distributed by:
Abbott Diabetes Care
666 Doncaster Road
Doncaster 3108
Victoria, Australia
ABN 95000 180 389
1800-801-478
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
©2019-2021 Abbott ART43974 Rev. A 02/21
ART43974_rev-A_cover.indd 1-2
ART43974_rev-A_cover.indd 1-2
FLASH GLUCOSE MONITORING SYSTEM
.257"
.224"
4.6"
User's Manual
2/17/21 8:33 AM
2/17/21 8:33 AM

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Summary of Contents for Abbott FreeStyle Libre 2

  • Page 1 Doncaster 3108 Victoria, Australia ABN 95000 180 389 1800-801-478 FLASH GLUCOSE MONITORING SYSTEM 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 ©2019-2021 Abbott ART43974 Rev. A 02/21 .257”...
  • Page 2 4.6” 4.6” Your Name _________________________________________________ .257” ART43974_rev-A_cover.indd 3-4 ART43974_rev-A_cover.indd 3-4 2/17/21 8:33 AM 2/17/21 8:33 AM .224”...

  • Page 3: Table Of Contents

    Contents Reader Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Important Safety Information .
  • Page 4 Reviewing Your History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Troubleshooting .

  • Page 5: Reader Symbols

    Reader Symbols Symbol What It Means Symbol What It Means Active Sensor Sensor communicating with Reader Direction your glucose is going . See Checking Your Sensor not communicating with Reader Glucose section for more information . Blood glucose or ketone test Caution View previous/next screen Settings...

  • Page 6: Important Safety Information

    Magnetic Resonance Imaging (MRI) . The FreeStyle Libre 2 Flash Glucose Monitoring System Reader (“Reader”) when used with a FreeStyle Libre 2 Flash Glucose Monitoring System WARNING: Sensor (“Sensor”) is a real time, continuous glucose monitoring (CGM) •...
  • Page 7 Cautions and Important System Information: When to remove the Sensor: • On rare occasions, you may get inaccurate Sensor glucose readings . What the System has not been evaluated for: If you believe your glucose readings are not correct or do not match •...
  • Page 8 What to know before using the System: What to know about the Reader’s Built-in Meter: • Make sure that your Reader and Sensor kits are kept in a safe place, • The Reader is designed to be used only with FreeStyle Optium blood under your control .

  • Page 9: Interfering Substances

    . The Reader only works with FreeStyle Libre understand how long ascorbic acid is active in your body . 2 Sensors and cannot be used with other Sensors . The FreeStyle Libre 2 Sensor automatically communicates with the Reader and can give you glucose alarms if you choose to turn those on .

  • Page 10: Reader Kit

    Sensor Kit The Sensor Kit includes: The Reader Kit includes: • • • • • Sensor Pack Alcohol wipe FreeStyle Libre 2 Reader Power Adapter Quick Start Guide • • • • • USB Cable User’s Manual Performance Data Insert...
  • Page 11 The Reader Home Screen provides access to information about your The Sensor Glucose Readings screen appears after you use the Reader to glucose and the System . You can press the Home Button to get to the scan your Sensor . Your Reading includes your Current Glucose, a Glucose Home Screen .

  • Page 12: Data Management Software

    Data Management Software Setting up Your Reader for the First Time To upload data from the Reader, please contact Customer Service and Before using the System for the first time, the Reader must be set up . learn more about the data management software you can use . You are responsible for keeping your computer secure and up to date, for Step Action...
  • Page 13 Step Action Step Action Set the Current Date using the arrows on the The Reader now displays important information about two key Current Date touchscreen . Touch next to continue . topics to help you use the system: • How to understand the Glucose Trend Arrow included on June 2018 the Glucose Reading screen .

  • Page 14: Using Your Sensor

    Applying Your Sensor Using Your Sensor Action Step Apply Sensors only on the back of your upper CAUTION: arm . If placed in other areas, the Sensor may • The Sensor Pack and Sensor Applicator are packaged as a not function properly and could give inaccurate set (separately from the Reader) and have the same Sensor readings .
  • Page 15 Step Action Step Action Open the Sensor Pack by peeling the lid off The Sensor Applicator is prepared and ready to completely . Unscrew the cap from the Sensor apply the Sensor . Applicator and set the cap aside . CAUTION: The Sensor Applicator now CAUTION: Do NOT use if the Sensor Pack or contains a needle .

  • Page 16: Starting Your Sensor

    Starting Your Sensor Action Step Step Action Gently pull the Sensor Applicator away from your body . The Sensor should now be attached to your Press the Home Button to turn on the Reader . skin . Sensor Note: Applying the Sensor may cause bruising or bleeding .

  • Page 17: Checking Your Glucose

    Checking Your Glucose Step Action Step Action The Reader displays your current glucose reading along with your glucose graph and an arrow Glucose Going Turn the Reader on by pressing indicating the direction your glucose is going . mmol 10:23pm the Home Button or touch Ends in 14 days Check Glucose from the Home...
  • Page 18 Sensor Glucose Readings The Glucose Trend Arrow gives you an indication of the direction your glucose is going . Glucose Going Glucose is rising quickly Glucose Trend Arrow (more than 0 . 1 mmol/L per minute) mmol Glucose is rising (between 0 .06 and 0 .
  • Page 19 The following table shows messages you may see with your glucose Display What To Do readings . If your glucose is projected to be higher than Display What To Do Glucose Going 13 .3 mmol/L or lower than 3 .9 mmol/L within 15 minutes, you will see a message on the screen .

  • Page 20: Alarms

    Alarms IMPORTANT: What to know about glucose 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 Scan your Sensor often to check your glucose . If you get a them ON .

  • Page 21: Setting Alarms

    Setting Alarms Work with your health care professional to determine your alarm settings . IMPORTANT: How to prevent missed alarms • For you to receive alarms, they must be turned ON and you Step Action should ensure that your Reader is within 6 metres (20 ft) of you at all times .
  • Page 22 Step Action Alarm How to Set Select the alarm you want to turn on and set . High The High Glucose Alarm is off by default . Change Alarm Settings Glucose Low Glucose Alarm: Notifies you when your Touch the slider to turn the alarm Low Glucose Alarm High Glucose Alarm glucose is below the level you set .

  • Page 23: Setting Alarm Sounds

    Setting Alarm Sounds Action Step Step Action When you are finished setting your alarms, Change Alarm touch OK . The Alarms Settings screen now Settings From the Home screen, touch the Low Glucose Alarm shows your current alarm settings . Touch OK 10:23pm Ends in 14 days .

  • Page 24: Using Alarms

    Using Alarms What you See What it Means The Signal Loss Alarm notifies you if your Sensor What you See What it Means Signal Loss Alarm has not communicated with the Reader for 20 The Low Glucose Alarm notifies you if your minutes and you are not receiving Low or High Low Glucose Alarm Scan Sensor now?

  • Page 25: Adding Notes

    Step Action Adding Notes After you tick the box for food and Notes can be saved with your glucose readings . You can add a note at Add Notes insulin notes, the symbol appears the time of your glucose reading or within 15 minutes after your reading Rapid-Acting Insulin to the right of the note .

  • Page 26: Reviewing Your History

    Step Action Reviewing Your History Use the arrows to view the available options . Reviewing and understanding your glucose history can be an important Review History tool for improving your glucose control . The Reader stores about 90 days Logbook of information and has several ways to review your past glucose readings, Daily Graph notes, and other information .

  • Page 27: Logbook

    The Logbook and Daily Graph show detailed information, while other Daily Graph history options show summaries of information over a number of days . A graph of your Sensor glucose readings by day . Logbook Daily Graph (mmol/L) The graph shows your Target Glucose Range and symbols for food or rapid-acting insulin notes you Entries for each time you scanned your Sensor have entered .

  • Page 28: Other History Options

    Other History Options A graph showing the percentage of time your Time In Target Use the arrows to view information about your last 7, 14, 30, or 90 days . Sensor glucose readings were above, below, or Above within your Target Glucose Range . In Target Information about the average of your Sensor Below...

  • Page 29: Removing Your Sensor

    Removing Your Sensor Replacing Your Sensor Your Sensor automatically stops working after 14 days of wear and Step Action 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 Pull up the edge of the adhesive that keeps your problem with the Sensor currently in use .

  • Page 30: Using Reminders

    Step Action Using Reminders Touch to select how often you want the reminder to Repeat: You can use Reminders to help you remember things like checking your Once, Daily, or Timer . glucose or taking insulin . Note: You can set the reminders for a specific time (e . g . 8:30 am) Step Action or as a timer (e .g .

  • Page 31: Using The Built-In Meter

    Using the Built-in Meter IMPORTANT: 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 Use the Reader within the test strip operating temperature solution .

  • Page 32: Blood Glucose Testing

    Blood Glucose Testing Step Action You can use the built-in meter to check your blood glucose, whether you Check the test strip expiry date . are wearing a Sensor or not . You can perform a blood glucose test on 13758 2021/ 03 your fingertip or approved alternate site .
  • Page 33 Step Action Display What To Do If LO appears on the Reader, your result is lower You will see a butterfly on the screen while you Low Glucose than 1 . 1 mmol/L . If HI appears on the Reader, your wait for your result .

  • Page 34: Blood Ketone Testing

    After you get your blood glucose result, you can add Notes by touching Step Action 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 . Check the test strip expiry date .
  • Page 35 Your Blood Ketone Results Step Action 10:23pm Blood ketone results are marked on the results Use your lancing device to obtain a blood drop screen and in the Logbook with the word Ketone . Apply Blood and apply blood to the white area at the end of mmol the test strip .

  • Page 36: Control Solution Testing

    Control Solution Testing Display What To Do You should do a control solution test when you are not sure of your If your blood ketone is high, you will see a test strip results and want to check that your Reader and test strips are High Ketone message on the screen .
  • Page 37 Step Action Step Action From the Home Screen, touch the Settings Insert the test strip with the three black lines 10:23pm Ends in 14 days facing up . Push the strip until it stops . symbol . Scroll down using the arrow and touch Control Solution Test .

  • Page 38: Using The Rapid-Acting Insulin Calculator

    Using the Rapid-Acting Insulin Calculator Control Solution Results 10:23pm Compare the control solution result to the This optional feature requires an understanding of the use of insulin . range printed on the test strip instructions Misuse or misunderstanding of this feature and the suggested dose for use .
  • Page 39 Step Action CAUTION: The rapid-acting insulin calculator cannot account Enter information about any Have you forgotten for all the factors that may affect your insulin dose . These to log any rapid-acting rapid-acting insulin you may have insulin you have taken include incorrectly entered data, incorrectly set date or time, since X:XX? forgotten to log .
  • Page 40 Step Action Step Action If your calculator was programmed with Easy Review your suggested dose . If needed, use the Suggested Dose Breakfast Setup, touch the meal you plan to eat now . Touch arrow buttons to adjust your suggested dose for Adjust if needed Lunch next .
  • Page 41 Step Action If your health care professional turned on the Active 10:23pm Ends in 14 days Insulin feature, the symbol may appear on your Touch log dose to save to your Logbook and take your dose . Home Screen . It shows an estimate of the amount of Your dose is only saved to the Logbook if you touch log dose .

  • Page 42: Charging The Reader

    Charging the Reader Changing the Reader Settings A fully charged Reader battery should last up to 4 days . Your battery You can go to the Settings menu to change many settings on the Reader, life may vary depending on your usage . A Low Battery message like alarm settings, sound &...
  • Page 43 Action Step Step Action • Touch the setting you want to change: View Event Logs: A list of events recorded by the Alarms – See Alarms section for information on setting alarms Reader, which may be used by Customer Service to help (cont.) troubleshoot your System Sound &...

  • Page 44: Living With Your System

    Activity What You Need To Know Living With Your System Travelling by Air You may use your System while on an aircraft, Activities following any requests from the flight crew . Your System can be used during a wide variety of activities . •...

  • Page 45: Cleaning

    Disposal Activity What You Need To Know Reader, Sensor, USB Cable, and Power Adapter: Travelling by Air symbol may appear on your glucose These devices must not be disposed of via municipal waste collection . (cont.) graph indicating the Reader time was changed . Contact the manufacturer for details .

  • Page 46: Troubleshooting

    Problems at the Sensor Application Site Troubleshooting Problem What It May Mean What To Do This section lists problems or observations that you may have, the possible cause(s), and recommended actions . If the Reader experiences The Sensor is The site is not free 1 .

  • Page 47: Problems Starting Your Sensor Or Receiving Sensor

    Problems Starting Your Sensor or Receiving Sensor Display What It May Mean What To Do Readings New Sensor You scanned a new Your Reader can only be used Display What It May Mean What To Do Found Sensor before your with one Sensor at a time .

  • Page 48: Problems Receiving Glucose Alarms

    Problems Receiving Glucose Alarms Display What It May Mean What To Do Glucose Your Sensor is too Move to a location where the Problem What It May Mean What To Do Reading hot or too cold . temperature is appropriate and You are not You have not turned Touch the Settings symbol...

  • Page 49: Blood Glucose Or Ketone Error Messages

    Blood Glucose or Ketone Error Messages Problem What It May Mean What To Do Error You are not You may have set an Confirm your alarm settings are What It May Mean What To Do Message receiving alarm level that is appropriate .
  • Page 50 Error Error What It May Mean What To Do What It May Mean What To Do Message Message Blood drop is too 1 . Review the testing Blood was applied 1 . Review the testing small . instructions . to the test strip too instructions .

  • Page 51: Problems Checking Your Blood Glucose Or Ketone

    Problems Checking Your Blood Glucose or Ketone Error What It May Mean What To Do Message Problem What It May Mean What To Do Test strip may be 1 . Check that you are using The Reader Test strip is not 1 .

  • Page 52: Perform A Reader Test

    Perform a Reader Test Problem What It May Mean What To Do If you think the Reader is not working properly, you can The test Blood sample is too 1 . See test strip instructions System Status check the Reader by performing a Reader Test . Touch does not small .

  • Page 53: Professional Options

    Changing Dose Increments Professional Options You can set the insulin dose increments to either 1 .0 or 0 .5 units for use This section is only meant for health care professionals . It describes the with the Rapid-acting insulin calculator and insulin notes . access code-protected features of the Reader .

  • Page 54: Setting Up The Insulin Calculator

    Setting up the Insulin Calculator 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 The insulin calculator can help your patients calculate their rapid-acting rapid-acting insulin for meals .

  • Page 55: Easy Setup Of The Insulin Calculator

    Easy Setup of the Insulin Calculator Action Step Action Step Enter the Correction Factor (for example: if 1 unit Correction Factor of insulin lowers blood glucose 2 . 8 mmol/L, then Choose the Easy option on the slide bar and 1 u insulin for the correction factor is 2 .8) .
  • Page 56 Notes about the Easy Option: Calculator Settings - Easy Option • The calculator estimates the amount of rapid-acting insulin still in the This page can be used to record insulin calculator settings . body and how much longer it may be active (if the correction factor is set to “no correction insulin”, active insulin is not calculated) .

  • Page 57: Advanced Setup Of The Insulin Calculator

    Advanced Setup of the Insulin Calculator Action Step Step Action If you chose to enter Grams of carbs in Step 2: Carbohydrate Ratio The rapid-acting insulin dose suggestion is based Choose the Advanced option on the slide bar 1 u insulin for Choose Setup Option on grams of carbs .
  • Page 58 Step Action Step Action If you chose to enter Carb Portions in Step 2: The Select how you want your patient to correct their How does your Carb Portions Definition patient correct their glucose . Touch next rapid-acting insulin dose suggestion is based on glucose? 1 portion = carbohydrate portions .
  • Page 59 Action Step Action Step Enter the Insulin Duration . This is the amount of Enter the Correction Factor (for example: if 1 Correction Factor Insulin Duration unit of insulin lowers blood glucose 2 .8 mmol/L, time that rapid-acting insulin remains active in 1 u insulin for 4:30 then the correction factor is 2 .8) .
  • Page 60 Step Action Notes about the Advanced Option: • Select whether or not to show the Active Insulin The calculator estimates the amount of rapid-acting insulin still in Do you want the Active Insulin symbol symbol on the Home Screen . the body and how much longer it may be active .
  • Page 61 This graph shows how the insulin calculator estimates the amount of Calculator Settings - Advanced Option active insulin as a function of logged insulin dose and insulin duration This page can be used to record insulin calculator settings . over time . It also shows the relationship between the symbol and amount of active insulin .

  • Page 62: Changing The Insulin Calculator Settings

    Changing the Insulin Calculator Settings This is the estimated amount blood Correction Factor Step Action glucose will drop by taking one unit 1 unit of insulin for of insulin . (Option to enter by time of From the Home Screen, touch the Settings day .) symbol .

  • Page 63: System Specifications

    System Specifications Sensor transmission 6 metres (20 ft) unobstructed range See test strip and control solution instructions for use for additional specifications . Operating temperature 10 °C to 45 °C Sensor Specifications Sensor glucose assay Sensor Applicator and Amperometric electrochemical sensor method Sensor Pack storage 4 °C to 25 °C...
  • Page 64 Reader operating 10 °C to 45 °C Mean service life 3 years of typical use temperature Reader storage Abbott Diabetes Care PRT25847 -20 °C to 60 °C Power Adapter temperature Operating temperature: 10 °C to 40 °C ART43974_rev-A_manual.indd 119-120 ART43974_rev-A_manual.indd 119-120...

  • Page 65: Rapid-Acting Insulin Calculator Specifications

    Reader that activated the Sensor . Quality of Service (QoS): Mealtime insulin doses QoS for the FreeStyle Libre 2 Reader and Sensor wireless communications using NFC is assured within Units of insulin 0 to 50 (breakfast, lunch, dinner) the effective range of 4 cm between the Sensor and Reader that is specified to occur within 15 seconds .

  • Page 66: Labelling Symbols

    Sensor code Non-ionizing radiation CODE • 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 67 Guidance and manufacturer’s declaration – Guidance and manufacturer’s declaration – electromagnetic emissions electromagnetic immunity The System is intended for use in the electromagnetic environment specified below. The customer or 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.
  • Page 68 IMMUNITY IEC 60601 Compliance Electromagnetic IMMUNITY IEC 60601 Compliance Electromagnetic test test level Level environment – guidance test test level Level environment – guidance Surge ±1 kV ±1 kV Mains power quality should be that Power frequency 30 A/m 30 A/m Power frequency magnetic fields differential differential...
  • Page 69 380 – 390 TETRA 400 Pulse of the System, including cables modulation IEC 61000-4-3 80 MHz to specified by Abbott Diabetes Care. 18 Hz 2.7 GHz Otherwise, degradation of the performance of the System could 430 – 470 GMRS 460, FRS 460 ±...
  • Page 70 Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should IMMUNITY Test be less than the compliance level in each frequency range. Band Maximum Distance TEST frequency Service Modulation (MHz) power (W) LEVEL Interference may occur in the vicinity of equipment marked with the following symbol: (MHz) (V/m) Field strengths from fixed transmitters, such as base stations for radio (mobile/cordless)
  • Page 71 DEFINITIONS “Font Software” refers to the set of files released by the Copyright Holder(s) under this licence and clearly marked ©2013 Abbott as such. This may include source files, build scripts and documentation. Licenced under the Apache Licence, Version 2.0 (the “Licence”); you may not use this file except in compliance “Reserved Font Name”...
  • Page 72 5) The Font Software, modified or unmodified, in part or in whole, must be distributed entirely under this licence, and must not be distributed under any other licence. The requirement for fonts to remain under this licence does not apply to any document created using the Font Software. TERMINATION This licence becomes null and void if any of the above conditions are not met.

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