Abbott FreeStyle Libre User Manual
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Abbott FreeStyle Libre User Manual

Flash glucose monitoring system
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4.6"
Distributed by:
Abbott Laboratories
Abbott Place
219 Golf Club Terrace
Constantia Kloof
1709
Johannesburg
South Africa
0800 222 688
+27 11 858 2375
FreeStyle and related brand marks are trademarks of Abbott Diabetes Care Inc. in
various jurisdictions.
Patent: https://www.abbott.com/patents
©2017 Abbott ART34745-008 Rev. A 03/17
ART34745-008_rev-A_cover.indd 1-2
DO NOT PRINT FROM THIS FILE -
FOR REFERENCE ONLY
Abbott Diabetes Care Ltd.
Range Road
Witney, Oxon
OX29 0YL, UK
.257"
.224"
4.6"
User's Manual
FLASH GLUCOSE MONITORING SYSTEM
3/28/17 1:19 PM

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Summary of Contents for Abbott FreeStyle Libre

  • Page 1 Constantia Kloof 1709 Johannesburg South Africa 0800 222 688 +27 11 858 2375 FreeStyle and related brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions. Patent: https://www.abbott.com/patents FLASH GLUCOSE MONITORING SYSTEM Abbott Diabetes Care Ltd. Range Road Witney, Oxon ©2017 Abbott ART34745-008 Rev.
  • Page 2 4.6” 4.6” Your Name _________________________________________________ .257” ART34745-008_rev-A_cover.indd 3-4 3/28/17 1:19 PM .224”...

  • Page 3: Table Of Contents

    FreeStyle Libre Software . . . . . . . . . . . . . . . . . . .
  • Page 4 Warranty Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91 Living With Your FreeStyle Libre System . . . . . . . . . . . . . . . 60 ART34745-008_rev-A_manual.indd 2-3...

  • Page 5: Reader Symbols

    Reader Symbols Symbol What It Means Symbol What It Means Time changed on Reader Active Sensor Direction your glucose is going . See Checking Your Reminders Glucose section for more information Blood glucose or ketone test Caution Settings View previous/next screen Control solution test result Notes Low battery...

  • Page 6: Important Safety Information

    FreeStyle Libre Flash Glucose Monitoring System and also for interpreting per minute), interstitial fluid glucose levels as measured by the or assisting the child to interpret FreeStyle Libre readings . It is designed to replace blood glucose testing in the self-management of diabetes with the FreeStyle Libre Flash Glucose Monitoring System Sensor may not exceptions listed below .
  • Page 7 System-Related Information • The FreeStyle Libre Flash Glucose Monitoring System is designed to be CAUTION: used only with FreeStyle Optium blood glucose and blood ketone test • On rare occasions, you may get inaccurate Sensor glucose strips and MediSense control solution .

  • Page 8: Getting To Know Your System

    X-ray, MRI (Magnetic Resonance Imaging) or CT (Computed Tomography) scan, remove the The FreeStyle Libre Flash Glucose Monitoring System has two main parts: a Sensor you are wearing and apply a new one after the appointment .

  • Page 9: Reader Kit

    Sensor Kit Reader Kit The Sensor Kit includes: The Reader Kit includes: • • • • • Sensor Pack Product insert FreeStyle Libre Reader Power Adapter Quick Start Guide • • • USB Cable User’s Manual Sensor Applicator Touchscreen USB Port Used to charge the Reader and connect it to a computer.
  • Page 10 The Sensor Glucose Readings screen appears after you use the Reader The Reader Home Screen provides access to information about your to scan your Sensor . Your Reading includes your Current Glucose, a glucose and the System . You can press the Home Button to get to the Glucose Trend Arrow indicating which way your glucose is going, and a Home Screen .

  • Page 11: Freestyle Libre Software

    FreeStyle Libre Software Setting up Your Reader for the First Time FreeStyle Libre software can be used to view reports and change Reader Before using the System for the first time, the Reader must be set up . settings . The software is compatible with most Windows and Mac operating systems .
  • Page 12 Step Action Step Action Set the Current Time . Touch next to continue . The Reader now displays important information about two key Current Time topics to help you use the system: • CAUTION: It is very important to set the time How to understand the Glucose Trend Arrow included on and date correctly .

  • Page 13: Using Your Sensor

    Applying Your Sensor Using Your Sensor Step Action Apply Sensors only on the back of your upper CAUTIONS: • 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 14 Step Action Action Step 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 15: Starting Your Sensor

    Starting Your Sensor Step Action 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 16: 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 22:23 the Home Button, or touch Ends in 14 days Check Glucose from the Home...
  • Page 17 The Glucose Trend Arrow gives you an indication of the direction your glucose is going . Sensor Glucose Readings Glucose is rising quickly (more than 0 . 1 mmol/L per minute) Glucose Going Glucose Trend Arrow Glucose is rising (between 0 .06 mmol/L and 0 . 1 mmol/L per minute) mmol Current Glucose Glucose is changing slowly...
  • Page 18 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 19: Adding Notes

    Adding Notes Step Action 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 was obtained .

  • Page 20: 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 21: Logbook

    Reader time was changed . Gaps in the graph the last 15 minutes and you have not used may result or glucose readings may be hidden . FreeStyle Libre software to create reports . ART34745-008_rev-A_manual.indd 33-34 3/28/17 1:37 PM...

  • Page 22: Other History Options

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

  • Page 23: Removing Your Sensor

    . CAUTION: If the glucose readings from the FreeStyle Libre Flash Glucose Monitoring System do NOT seem to match with how you feel, check to make sure that your Sensor has not come loose .

  • Page 24: Using Reminders

    Step Action Using Reminders Set the reminder Time using the arrows on the touchscreen . You can use Reminders to help you remember to check your glucose, take Touch save . insulin, or as a general alarm . Step Action From the Reminders screen, you can turn the Reminders From the Home Screen, touch the...

  • Page 25: 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 control Use the Reader within the test strip operating temperature solution .

  • Page 26: 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 2016/ 03 your fingertip or approved alternate site .
  • Page 27 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 28: 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 29 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 30: Control Solution Testing

    Control Solution Testing Display What To Do You should do a control solution test when you are not sure of your test If your blood ketone is high, you will see a strip results and want to check that your Reader and test strips are working High Ketone message on the screen .
  • Page 31 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 facing up . Push the strip until it stops . . Touch Control Solution Test to do symbol a control solution test .

  • Page 32: 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 7 days . Your battery range printed on the test strip instructions life may vary depending on your usage . A Low Battery message for use .

  • Page 33: 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 Time & Date or Sounds . The Settings menu is also where you go to do Sounds –...

  • Page 34: Living With Your Freestyle Libre System

    Living With Your FreeStyle Libre System • View Event Logs: A list of events recorded by the Your FreeStyle Libre Flash Glucose Monitoring System can be used during Reader, which may be used by Customer Service to help a wide variety of activities .

  • Page 35: Maintenance And Disposal

    . Maintenance Note: If you are changing time zones, you can The FreeStyle Libre Flash Glucose Monitoring System has no serviceable change the time and date settings on the Reader parts . by touching the Settings symbol from the Home Screen, then Time &...

  • Page 36: 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 an error, a The Sensor is The site is not free 1 .

  • Page 37: Problems Starting Your Sensor Or Receiving

    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 Found Sensor before your with one Sensor at a time . If Display What It May Mean What To Do...

  • Page 38: Blood Glucose Or Ketone Error Messages

    Blood Glucose or Ketone Error Messages Display What It May Mean What To Do Error Glucose Your Sensor is too Move to a location where the What It May Mean What To Do Message Reading hot or too cold . temperature is appropriate and Unavailable scan again in a few minutes .
  • Page 39 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 40: 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 41: Perform A Reader Test

    Customer Service Customer Service is available to answer any questions you may have about your FreeStyle Libre Flash Glucose Monitoring System . Please go to the back cover of this manual for your Customer Service phone number . ART34745-008_rev-A_manual.indd 73-74...

  • Page 42: System Specifications

    System Specifications Sensor life Up to 14 days See test strip and control solution instructions for use for additional specifications . 8 hours (glucose readings stored every Sensor memory Sensor Specifications 15 minutes) Sensor glucose assay Amperometric electrochemical sensor method Operating temperature 10 °C to 45 °C Sensor glucose reading...
  • Page 43 90 days of typical use Mean service life 3 years of typical use Reader operating 10 °C to 45 °C Abbott Diabetes Care PRT25613 temperature Power Adapter Operating temperature: 10 °C to 40 °C Reader storage Abbott Diabetes Care PRT21373 -20 °C to 60 °C...

  • Page 44: Labelling Symbols

    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 Batch code Non-ionizing radiation may result in increased EMISSIONS or decreased IMMUNITY of the System.
  • Page 45 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 46 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 3 A/m 3 A/m Power frequency magnetic fields differential differential...
  • Page 47 IMMUNITY IEC 60601 Compliance Electromagnetic IMMUNITY IEC 60601 Compliance Electromagnetic test test level Level environment – guidance test test level Level environment – guidance Conducted RF 3 Vrms 3 Vrms Portable and mobile RF Radiated RF 3 V/m 3 V/m Recommended separation communications equipment should distance...
  • Page 48 Recommended separation distances between portable 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 and mobile RF communications equipment and the cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due System to fixed RF transmitters, an electromagnetic site survey should be considered.
  • Page 49 For transmitters rated at a maximum output power not listed above, the recommended separation Hereby, Abbott Diabetes Care Ltd, declares that the FreeStyle Libre Flash Glucose Monitoring System is in compliance with the essential requirements and other distance d in metres (m) can be estimated using the equation applicable to the frequency of the relevant provisions of the R&TTE Directive .

  • Page 50: Warranty Statement

    User‘s Manual . Abbott’s sole obligation is to replace the Reader, free of charge, with a same or alternative meter as determined by Abbott in its sole discretion .

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