Abbott FreeStyle Libre 2 Manual
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Abbott FreeStyle Libre 2 Manual

Flash glucose monitoring system
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4.6"
Distributor and registration holder:
Geffen Medical Ltd
5 Kinneret Bnei Brak B.S.R 3
P.O. Box 48092 Tel Aviv 6148002 Israel
*6364
03-6900300
Approval no. 2630413
Importer (European Union):
Abbott GmbH
Max-Planck-Ring 2
65205 Wiesbaden
Germany
The shape of the circle sensor unit, FreeStyle, Libre, and related brand marks are
owned by Abbott.
Patent: https://www.abbott.com/patents
©2020 Abbott ART41600-101 Rev. A 10/20
ART41600-101_rev-A_cover.indd 1-2
ART41600-101_rev-A_cover.indd 1-2
DO NOT PRINT FROM THIS FILE -
FOR REFERENCE ONLY
Manufacturer
Abbott Diabetes Care Ltd.
Range Road
Witney, Oxon
OX29 0YL, UK
.257"
.224"
4.6"
User's Manual
FLASH GLUCOSE MONITORING SYSTEM
10/7/20 2:54 PM
10/7/20 2:54 PM

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Summary of Contents for Abbott FreeStyle Libre 2

  • Page 1 The shape of the circle sensor unit, FreeStyle, Libre, and related brand marks are owned by Abbott. Patent: https://www.abbott.com/patents Manufacturer Abbott Diabetes Care Ltd. Range Road Witney, Oxon OX29 0YL, UK ©2020 Abbott ART41600-101 Rev. A 10/20 .257” ART41600-101_rev-A_cover.indd 1-2 ART41600-101_rev-A_cover.indd 1-2 10/7/20 2:54 PM 10/7/20 2:54 PM .224”...
  • Page 2 4.6” 4.6” Your Name _________________________________________________ .257” ART41600-101_rev-A_cover.indd 3-4 ART41600-101_rev-A_cover.indd 3-4 10/7/20 2:54 PM 10/7/20 2:54 PM .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 Glucose section for more information . Sensor not communicating with Reader Caution Blood glucose or ketone test View previous/next screen Notes Settings...

  • Page 6: Important Safety Information

    The FreeStyle Libre 2 Flash Glucose Monitoring System Reader (“Reader”) • when used with a FreeStyle Libre 2 Flash Glucose Monitoring System Do not ignore symptoms that may be due to low or high blood Sensor (“Sensor”) is indicated for measuring interstitial fluid glucose levels glucose .
  • Page 7 Cautions and Important System Information: When to remove the Sensor: What the System has not been evaluated for: • On rare occasions, you may get inaccurate Sensor glucose readings . If you believe your glucose readings are not correct or do not match •...
  • Page 8 What to know about wearing the Sensor: What to know about the Reader’s Built-in Meter: • Do not reuse Sensors . The Sensor and Sensor Applicator are designed for • The Reader is designed to be used only with FreeStyle Optium blood single use .

  • Page 9: Getting To Know Your System

    . The Reader only works with FreeStyle Libre your System . 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 . The Reader also has Your System comes in a Reader Kit and a Sensor Kit .

  • Page 10: Reader Kit

    Sensor Kit The Sensor Kit includes: The Reader Kit includes: • • • • • Sensor Pack Product insert FreeStyle Libre 2 Reader Power Adapter Quick Start Guide • • • • Sensor Applicator 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 visit www .FreeStyleLibre .com and find out more about the data management software that you can use . 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 .
  • 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 Step Action Apply Sensors only on the back of your upper CAUTION: arm . Avoid areas with scars, moles, stretch marks, • The Sensor Pack and Sensor Applicator are packaged as a or lumps . set (separately from the Reader) and have the same Sensor Select an area of skin that generally stays flat code .
  • 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 Press the Home Button to turn on the Reader . your 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 . 22:23 the Home Button or touch Ends in 14 days Check Glucose from the 14:00...
  • 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 2 mg/dL per minute) Glucose is rising Current Glucose (between 1 and 2 mg/dL per minute) Target Glucose Range Glucose is changing slowly Your Target Glucose Range...
  • 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 240 mg/dL or lower than 70 mg/dL 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 • Scan your Sensor often to check your glucose . If you get a with the Reader to give you Low and High Glucose Alarms if you turn Low or High Glucose Alarm, you must obtain a glucose 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 • Step Action For you to receive alarms, they must be turned ON and you should ensure that your Reader is within 6 metres (20 ft) of you From the Home screen, touch the Settings 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 Low Glucose Alarm: Notifies you when your Glucose 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 22:23 Low Glucose Alarm shows your current alarm settings . Touch OK Ends in 14 days .

  • Page 24: Using Alarms

    Using Alarms What you See What it Means 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 The Low Glucose Alarm notifies you if your 20 minutes and you are not receiving Low or Low Glucose Alarm glucose drops below the level you set .

  • Page 25: Adding Notes

    Step Action Adding Notes After you check 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 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 . Daily Graph Logbook (mg/dL) 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 Average Glucose...

  • 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 Step Action (e .g .

  • Page 31: 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 IMPORTANT: glucose and blood ketone, or to test the meter and strips with • Use the Reader within the test strip operating temperature control 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 20 mg/dL . If HI appears on the Reader, your wait for your result . If sounds are turned on, the Reader beeps once when your result is ready .

  • 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 Check the test strip expiry date . to go to the Home Screen or hold the Home Button to turn the Reader off . 13758 2021/ 03 E .g .
  • Page 35 Your Blood Ketone Results Step Action 22:23 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 22:23 Ends in 14 days symbol . Scroll down using the arrow and facing up . Push the strip until it stops . touch Control Solution Test .

  • Page 38: Charging The Reader

    Control Solution Results Charging the Reader 22:23 Compare the control solution result to the A fully charged Reader battery should last up to 4 days . Your battery range printed on the test strip instructions life may vary depending on your usage . A Low Battery message for use .

  • Page 39: Changing The Reader Settings

    Step Action Changing the Reader Settings Touch the setting you want to change: You can go to the Settings menu to change many settings on the Reader, like alarm settings, sound & vibration, time & date, and report settings . Alarms –...

  • Page 40: Living With Your System

    Step Action Living With Your System • View Event Logs: A list of events recorded by the Activities Reader, which may be used by Customer Service to (cont.) Your System can be used during a wide variety of activities . help troubleshoot your System •...

  • Page 41: Cleaning

    Activity What You Need To Know Activity What You Need To Know Travelling by Air You may use your System while on an aircraft, Travelling by Air symbol may appear on your glucose following any requests from the flight crew . (cont.) graph indicating the Reader time was changed .

  • Page 42: Disposal

    Disposal Troubleshooting Reader, Sensor, USB Cable, and Power Adapter: These devices must not be disposed of via municipal waste collection . This section lists problems or observations that you may have, the Separate collection for electrical and electronic equipment waste per possible cause(s), and recommended actions .

  • Page 43: Problems At The Sensor Application Site

    Problems at the Sensor Application Site Problems Starting Your Sensor or Receiving Sensor Readings Problem What It May Mean What To Do Display 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 .
  • Page 44 Display What It May Mean What To Do Display What It May Mean What To Do New Sensor You scanned a new Your Reader can only be used Glucose Your Sensor is too Move to a location where the Found Sensor before your with one Sensor at a time .

  • Page 45: Problems Receiving Glucose Alarms

    Problems Receiving Glucose Alarms Problem What It May Mean What To Do 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 . You are not You have not turned Touch the Settings symbol...

  • Page 46: Blood Glucose Or Ketone Error Messages

    Blood Glucose or Ketone Error Messages Error What It May Mean What To Do Message Error What It May Mean What To Do Message Blood drop is 1 . Review the testing too small . instructions . The temperature is 1 .
  • Page 47 Error Error What It May Mean What To Do What It May Mean What To Do Message Message Blood was applied 1 . Review the testing Test strip may be 1 . Check that you are using to the test strip too instructions .

  • Page 48: Problems Checking Your Blood Glucose Or Ketone

    Problems Checking Your Blood Glucose or Ketone Problem What It May Mean What To Do Problem What It May Mean What To Do The test Blood sample 1 . See test strip instructions does not is too small . for use for re-application The Reader Test strip is not 1 .

  • Page 49: Perform A Reader Test

    Perform a Reader Test System Specifications If you think the Reader is not working properly, you can See test strip and control solution instructions for use for additional System Status check the Reader by performing a Reader Test . Touch specifications .
  • Page 50 Reader Specifications Sensor transmission 6 metres (20 ft) unobstructed range Blood glucose assay range 20 to 500 mg/dL Blood ketone assay range 0 . 0 to 8 . 0 mmol/L Operating temperature 10 °C to 45 °C Reader size 95 mm x 60 mm x 16 mm Sensor Applicator and Sensor Pack storage Reader weight...

  • Page 51: Labelling Symbols

    Type BF applied part Non-ionising radiation Mean service life 3 years of typical use CODE Sensor code Caution Abbott Diabetes Care PRT25613 Power Adapter Operating temperature: 10 °C to 40 °C Do not re-use Humidity limitation Abbott Diabetes Care PRT21373 USB Cable...

  • Page 52: Electromagnetic Compatibility

    • Portable and mobile RF communications equipment can affect the System. public low voltage power supply network that supplies buildings • The use of accessories, transducers and cables other than those specified by Abbott Diabetes Care Voltage fluctuations / Complies used for domestic purposes.
  • Page 53 Guidance and manufacturer’s declaration – IMMUNITY IEC 60601 Compliance Electromagnetic electromagnetic immunity test test level Level environment – guidance The System is intended for use in the electromagnetic environment specified below. The customer or Surge ±1 kV ±1 kV Mains power quality should be that the user of the System should assure that it is used in such an environment.
  • Page 54 IMMUNITY IEC 60601 Compliance Electromagnetic IMMUNITY IEC 60601 Compliance Electromagnetic test test level Level environment – guidance test test level Level environment – guidance Power frequency 30 A/m 30 A/m Power frequency magnetic fields Conducted RF 6 Vrms 6 Vrms Portable and mobile RF (50/60 Hz) should be at levels characteristic...
  • Page 55 Recommended separation distances between portable 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 metres (m). and mobile RF communications equipment and the Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should System...
  • Page 56 Open Source Components: Material Design Icons Copyright ©2014, Austin Andrews (http://materialdesignicons.com/), with Reserved Font Name Material Hereby, Abbott Diabetes Care Ltd., declares that the radio equipment type FreeStyle Libre 2 Reader is Design Icons. in compliance with Directive 2014/53/EU. The full text of the EU declaration of conformity is available Copyright ©2014, Google (http://www.google.com/design/) uses the license at https://github.com/google/...
  • Page 57 DEFINITIONS 4) The name(s) of the Copyright Holder(s) or the Author(s) of the Font Software shall not be used to promote, “Font Software” refers to the set of files released by the Copyright Holder(s) under this license and clearly marked endorse or advertise any Modified Version, except to acknowledge the contribution(s) of the Copyright as such.
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