Freestyle Libre User Manual
  1. Manuals
  2. Brands
  3. Freestyle Manuals
  4. Blood Glucose Meter
  5. Libre
  6. User manual

Freestyle Libre User Manual

Flash glucose monitoring system
Hide thumbs Also See for Libre:
Table of Contents

Advertisement

Quick Links

4.6"
Distributed by:
Abbott Diabetes Care Inc.
1360 South Loop Road
Alameda, CA 94502 USA
Customer Service: 1-855-632-8658
Monday through Friday,
8AM to 8PM Eastern Standard Time
www.FreeStyleLibre.com
FreeStyle, Libre, and related brand marks are trademarks of Abbott Diabetes Care Inc.
in various jurisdictions. Other trademarks are the property of their respective owners.
Patent: https://www.abbott.com/patents
©2018 Abbott ART38553-101 Rev. A 01/18
ART38553-101_rev-A_cover.indd 1-2
Manufacturer:
CAUTION: Federal law restricts this device
to sale by or on the order of a physician.
.257"
.224"
4.6"
User's Manual
FLASH GLUCOSE MONITORING SYSTEM
2/1/18 2:18 PM

Advertisement

Table of Contents
loading

Related Manuals for Freestyle Libre

Summary of Contents for Freestyle Libre

  • Page 1 Monday through Friday, 8AM to 8PM Eastern Standard Time www.FreeStyleLibre.com FreeStyle, Libre, and related brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions. Other trademarks are the property of their respective owners. Patent: https://www.abbott.com/patents FLASH GLUCOSE MONITORING SYSTEM...
  • Page 2 4.6” 4.6” Your Name _________________________________________________ .257” ART38553-101_rev-A_cover.indd 3-4 2/1/18 2:18 PM .224”...

  • Page 3: Table Of Contents

    FreeStyle Libre Software . . . . . . . . . . . . . . . . . . .
  • Page 4 Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .134 Living With Your FreeStyle Libre System . . . . . . . . . . . . . . . 80 ART38553-101_rev-A_manual.indd 2-3...

  • Page 5: Important Safety Information

    Indications For Use glucose: If you are experiencing symptoms that are not consistent The FreeStyle Libre Flash Glucose Monitoring System is a continuous with your glucose readings, consult your health care professional . glucose monitoring (CGM) device indicated for the management of •...

  • Page 6: Cautions And Limitations

    System is not approved for use in people under 18 years of age and • No alarms without a Sensor scan: The FreeStyle Libre System does Sensor readings in this population may be inaccurate . In general, not have alarms that will automatically notify you when you are...
  • Page 7 Do NOT use if Sensor Kit contents are past expiration date . • FreeStyle Libre System . Contact your health care professional before Do NOT use if the Reader appears to be damaged due to risk of electric continuing to use the FreeStyle Libre System .
  • Page 8 that generally stays flat during normal daily activities (no bending What to know about X-Rays: or folding) . Choose a site that is at least 1 inch away from an insulin • The Sensor should be removed prior to exposing it to an X-ray injection site .

  • Page 9: Reader Symbols

    The FreeStyle Libre Flash Glucose Monitoring System has a built-in Symbol What It Means blood glucose meter that is designed to be used only with FreeStyle Precision Neo blood glucose test strips and MediSense Glucose and Sensor may be inaccurate . Check blood glucose with Ketone Control Solution .

  • Page 10: Getting To Know Your System

    Getting to Know Your System Symbol What It Means The FreeStyle Libre Flash Glucose Monitoring System has two main parts: a handheld Reader and a disposable Sensor that you wear on your Time changed on Reader body . The Sensor does not need to be calibrated with blood glucose values .

  • Page 11: Reader Kit

    Reader Kit Sensor Kit The Reader Kit includes: The Sensor Kit includes: • • • • • FreeStyle Libre Reader Power Adapter Quick Start Guide Sensor Pack Alcohol wipe • • • • • USB Cable User’s Manual Quick Reference Guide...
  • Page 12 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 13: 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 Before using the System for the first time, the Reader must be set up . Reader settings . The software is compatible with most Windows and Mac operating systems .
  • Page 14 Step Action Step Action Set the Current Time . Touch next to continue . The Reader now displays important information about key Current Time topics to help you use the System: CAUTION: It is very important to set the time •...

  • Page 15: Using Your Sensor

    . The application of the Sensor is not code . Check that the Sensor codes match approved for other sites . Avoid areas with scars, FreeStyle Libre before using your Sensor Pack and Sensor moles, stretch marks, or lumps .
  • Page 16 Step Action Step Action Open the Sensor Pack by peeling the lid off The Sensor Applicator is prepared and ready to apply the Sensor . completely . Unscrew the cap from the Sensor Applicator and set the cap aside . CAUTION: The Sensor Applicator now contains a needle .

  • Page 17: 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 18: 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 High Turn the Reader on by pressing indicating the direction your glucose is going . 10:23pm the Home Button or touch Ends in 10 days Check Glucose from the Home...
  • Page 19 Sensor Glucose Readings The Glucose Trend Arrow gives you an indication of the direction your glucose is going . Glucose is rising quickly Glucose Going (more than 2 mg/dL per minute) Glucose Trend Arrow Check Blood Glucose When you see this symbol, do a blood glucose test Glucose is rising before making treatment...
  • Page 20 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 21: Making Treatment Decisions

    Getting familiar with the System could take days, weeks, or even months . to make as Sensor readings may not accurately reflect blood glucose levels: The more you check readings from the FreeStyle Libre System with a Do a blood glucose test if you see the Check...
  • Page 22 • When not to use Sensor Glucose readings for treatment decisions Scan your Sensor often to see how carbs, medication, exercise, illness, or stress levels impact your Sensor glucose readings . The information you Glucose is Falling Quickly or Rising Quickly get can help you figure out why your glucose sometimes goes too high Sensor glucose values, which are based on interstitial fluid glucose levels, or too low, and how to prevent it from doing so in the future .
  • Page 23 You Have Low or High Blood Glucose Symptoms Glucose or Glucose Going Low message, you will also see the symbol . Whenever you see the symbol, do a blood glucose test and treat Don’t ignore symptoms that may be due to low or high blood glucose . Do a blood glucose test and treat based on that result .

  • Page 24: Making Treatment Decisions - Advanced

    Making Treatment Decisions – Advanced This table provides some information on how you can factor the Glucose Trend Arrow into your treatment decisions . Remember that you should After you scan your Sensor, use all of the information on the never make a treatment decision based on the Glucose Trend Arrow alone .
  • Page 25 Treatment Decision Considerations Treatment Decision Considerations Glucose Glucose Trend Trend Low Glucose Glucose in High Glucose Low Glucose Glucose in High Glucose Arrow Arrow (< 70 mg/dL) Target Range (> 240 mg/dL) (< 70 mg/dL) Target Range (> 240 mg/dL) You will see the If you are about to eat, If you are about to eat,...
  • Page 26 Example Scenarios What you see What it means Next are some example scenarios to help you understand how to use Before breakfast: Before breakfast, your current glucose is the information on your screen . Always use all of the information on the 115 mg/dL .
  • Page 27 What you see What it means What you see What it means After exercising, you are feeling shaky, sweaty, Before lunch: When you checked your glucose before lunch, After exercising: it was 90 mg/dL and rising . Before eating lunch, and dizzy –...
  • Page 28 Other considerations What you see What it means Deciding how much rapid-acting insulin to take for different meals and After dinner, your current glucose is 215 mg/dL After dinner: situations can be difficult . Work with your health care professional to but there is no trend arrow .

  • Page 29: Adding Notes

    Bedtime Adding Notes • How often do you check your glucose before bed? Notes can be saved with your glucose readings . You can add a note at the • What do you consider a safe bedtime glucose? time of your glucose reading or within 15 minutes after your reading was •...

  • Page 30: Reviewing Your History

    Step Action Reviewing Your History After you check the box for food and Reviewing and understanding your glucose history can be an important Add Notes insulin notes, the symbol appears tool for improving your glucose control . The Reader stores about 90 days Rapid-Acting Insulin to the right of the note .

  • Page 31: Logbook

    IMPORTANT: Work with your health care professional entry, provided your glucose reading was within to understand your glucose history . the last 15 minutes and you have not used FreeStyle Libre software to create reports . ART38553-101_rev-A_manual.indd 53-54 2/1/18 2:13 PM...

  • Page 32: Other History Options

    Daily Graph Other History Options Use the arrows to view information about your last 7, 14, 30, or 90 days . A graph of your Sensor glucose readings by day . Daily Graph (mg/dL) The graph shows your Target Glucose Range and Information about the average of your Sensor symbols for food or rapid-acting insulin notes you Average Glucose...

  • Page 33: Removing Your Sensor

    Removing Your Sensor A graph showing the percentage of time your Time In Target Sensor glucose readings were above, below, or Above Step Action within your Target Glucose Range . In Target Below Pull up the edge of the adhesive that keeps your Target Range 80-140 mg/dL Sensor attached to your skin .

  • Page 34: Replacing Your Sensor

    Replacing Your Sensor Using Reminders You can use Reminders to help you remember to check your glucose, take Your Sensor automatically stops working after 10 days of data and insulin, or as a general alarm . 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 Action Step...

  • Page 35: Using The Reader's Built-In Meter

    Touch done to return to the Home Screen . 12:30pm Intended Use 00:00:00 The FreeStyle Libre Reader’s built-in meter is for use outside the body add new done only (in vitro diagnostic use) in the quantitative measurement of glucose in fresh whole blood for self testing by lay users from the fingers . It is...
  • Page 36 • The Reader is for use by a single person . It must not be used on Use only FreeStyle Precision Neo test strips . Other test strips may more than one person including other family members due to the produce inaccurate results .

  • Page 37: Blood Glucose Testing

    Blood Glucose Testing Step Action You can use the built-in meter to check your blood glucose, whether you are wearing a Sensor or not . Be sure to read the test strip instructions for Check the test strip expiration date . Do not use expired test use prior to using the built-in meter .
  • Page 38 Step Action Step Action Note: Use your lancing device to obtain a blood drop Apply Blood and apply blood to the white area at the end (cont.) • E-3 means the blood drop is too small, or incorrect test of the test strip . Refer to your lancing device procedure, or there may be a problem with the test strip .
  • Page 39 Display What To Do IMPORTANT: The built-in meter displays results from 20 - 500 mg/dL . Low or high blood glucose results can indicate a potentially serious If your glucose is higher than 240 mg/dL or lower medical condition . Low Glucose than 70 mg/dL, you will see a message on the screen .

  • Page 40: Control Solution Testing

    Control Solution Testing Step Action You should do a control solution test when you are not sure of your test From the Home Screen, touch the Settings strip results and want to check that your Reader’s built-in meter and test 10:23pm Ends in 10 days strips are working properly .
  • Page 41 Action Action Step Step You will see a butterfly on the screen while you Insert the test strip with the three black lines wait for the result . Do not remove the test strip facing up . Push the strip until it stops . (cont.) while the butterfly is on the screen .

  • Page 42: Charging The Reader

    Control Solution Results Charging the Reader 10:23pm Compare the control solution result to the range printed on the test strip instructions A fully charged Reader battery should last up to 7 days . Your battery for use . The result on your screen should be life may vary depending on your usage .

  • Page 43: Changing The Reader Settings

    Action Changing the Reader Settings Step 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 44: 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 (cont.) a wide variety of activities .
  • Page 45 Activity What You Need To Know Activity What You Need To Know Traveling by Air Traveling by Air You can safely use your System at all times while • The System can be exposed to common electrostatic (ESD) and electromagnetic on an aircraft .

  • Page 46: Maintenance And Disposal

    This device is not intended for use in healthcare or assisted-use settings Maintenance and Disposal such as hospitals, physician offices, or long-term care facilities because it has not been cleared by FDA for use in these settings, including for Cleaning and Disinfecting the Reader routine assisted testing or as part of glycemic control procedures .
  • Page 47 To clean and disinfect your Reader, you will need Clorox Healthcare Bleach Step Action Germicidal Wipes, EPA Reg . #67619-12 . For disinfection, use a second bleach wipe to wipe all outside These disinfectant wipes contain a 0 .55% Sodium Hypochlorite (NaOCl) surfaces of the Reader until they are wet .

  • Page 48: Troubleshooting

    Reader to not function properly . you press the Home Button or insert a test strip . Maintenance The FreeStyle Libre Flash Glucose Monitoring System has no serviceable Reader is outside Move the Reader to a parts . of its operating...

  • Page 49: 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 50 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 51: Blood Glucose Error Messages

    Blood Glucose Error Messages Error What It May Mean What To Do Message Error What It May Mean What To Do Message Blood drop is too 1 . Review the testing small . instructions . The temperature is 1 . Move the Reader and test 2 .
  • Page 52 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 53: Problems Checking Your Blood Glucose

    . off . 2 . Repeat the test using a new The test strip is Insert a new FreeStyle Precision test strip . damaged, used, or Neo test strip . 3 . If the test still does not start, unrecognizable by contact Customer Service .

  • Page 54: Perform A Reader Test

    5 grams Customer Service Customer Service is available to answer any questions you may have about your FreeStyle Libre Flash Glucose Monitoring System . Please go to Sensor power source One silver oxide battery the back cover of this manual for your Customer Service phone number .
  • Page 55 Reader Specifications Sensor data Up to 10 days Blood glucose assay 20 to 500 mg/dL range 8 hours (glucose readings stored every Sensor memory Reader size 95 mm x 60 mm x 16 mm 15 minutes) Operating temperature 50 °F to 113 °F Reader weight 65 grams Sensor Applicator and...
  • Page 56 (CRC) generation and verification of data . Radio Frequency RFID); ASK Modulation; 124 dBuV/m; Quality of Service (QoS): QoS for the FreeStyle Libre Reader and Sensor wireless 1 .5 inch communication range communications using the near field communications is assured within the effective range of 4 cm between the Sensor and Reader that is specified to occur within 15 seconds .

  • Page 57: Labeling Symbols

    Labeling Symbols CAUTION: Federal law restricts this device to sale by or on the order of a physician . Consult instructions for Use-by date This product contains electronic equipment, batteries, sharps and materials that may contact bodily fluids during use . Dispose of product in accordance with all applicable local Temperature limit Catalog number...

  • Page 58: Performance Characteristics

    Type 1, 4.2% Type 2). All subjects were aged eighteen and older. Subjects in the study required insulin to manage their diabetes. Each subject wore up to two FreeStyle Libre sensors on the back were within ±20 mg/dL / 20% of YSI reference.
  • Page 59 Agreement on Day 1 against YSI Reference Overall Accuracy against YSI reference The accuracy of CGM versus YSI reference on the first day of sensor wear was assessed by calculating Accuracy was measured by comparing the absolute relative difference between the System and the percentage of System readings that were within 15%, 20%, 30% and 40% for reference values reference YSI glucose values.
  • Page 60 181-300 1193 75.0 87.3 96.2 98.4 * Comparison to BG was performed using the FreeStyle Libre Reader’s built-in blood glucose meter. Different performance may be expected when compared to other models of blood glucose meters. 301-400 76.8 87.8 97.2 99.2 401-500 78.3...
  • Page 61 Concurrence of System and Reference (CGM vs. YSI) Table 6: Concurrence Analysis by Glucose Level The percentage of concurring glucose values (CGM vs. YSI) in each glucose reference range is YSI Glucose Level (mg/dL) presented for each CGM range in Table 6. For example, in the clinical study, when the System glucose 121- 161- 201-...
  • Page 62 Agreement with ‘LO’ and ‘HI’ CGM Reading against YSI Reference Concurrence Analysis by Glucose Trend Arrow Trend Arrow accuracy of the System, as assessed by concurrence analysis, is presented in Table 7. For The System reports glucose concentrations between 40 and 500 mg/dL. When the System example, in the clinical study, when the trend arrow indicated that glucose was changing slowly (-1 to determines that glucose level is below 40 mg/dL, it will report as ‘LO’...
  • Page 63 The accuracy of CGM versus YSI reference and BG reference was assessed by calculating the Accuracy by Day of Wear percentage of System readings that were within 15%, 20%, 30% and 40% for reference values After the 12 hour start-up period, the sensor can be worn for up to 10 days. To show sensor 80 mg/dL and above, and 15 mg/dL, 20 mg/dL, 30 mg/dL and 40 mg/dL for values below performance over time, the absolute relative difference between the System and reference YSI 80 mg/dL.
  • Page 64 System Glucose Availability Detection of Hypoglycemic and Hyperglycemic Events The System is designed to produce a glucose reading after each user initiated scan that is performed Table 12 shows the accuracy of the System’s Glucose Messages in informing the user of low or after the start-up time, through the wear period.
  • Page 65 Precision Table 12: Detection of Hypoglycemic and Hyperglycemic Events Precision of the System was evaluated by comparing the results from two separate sensors worn on 15 Minute Type of Notification Notification Status the same subject at the same time. Table 13 provides data from two separate sensors worn on 47 Interval subjects at the same time, providing 7,319 real-time pairs of CGM measurements, with a mean CV Notification of Hypoglycemic Events...

  • Page 66: Electromagnetic Compatibility (Emc)

    Guidance and manufacturer’s declaration – Electromagnetic Compatibility (EMC) electromagnetic emissions • The System needs special precautions regarding EMC and needs to be installed and put into service The System is intended for use in the electromagnetic environment specified below. The customer or according to the EMC information provided in this manual.
  • Page 67 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 68 IMMUNITY IEC 60601 Compliance Electromagnetic IMMUNITY IEC 60601 Compliance Electromagnetic test test level Level environment – guidance test test level Level environment – guidance Conducted RF 6 Vrms 6 Vrms Portable and mobile RF Power frequency 30 A/m 30 A/m Power frequency magnetic fields communications equipment should (50/60 Hz)
  • Page 69 Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) IMMUNITY IEC 60601 Compliance Electromagnetic telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast test test level Level environment – guidance cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due Recommended separation Radiated RF 10 V/m...
  • Page 70 For transmitters rated at a maximum output power not listed above, the recommended separation Recommended separation distances between portable distance d in meters (m) can be estimated using the equation applicable to the frequency of the and mobile RF communications equipment and the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according System to the transmitter manufacturer.

  • Page 71: Limited Warranty

    Limited Warranty Font License We hope that you are happy with your FreeStyle Libre system . Please refer to the ©2013 Abbott Licensed under the Apache License, Version 2 .0 (the “License”); you may User’s Manual before using your Reader for the first time .
  • Page 72 Your Rights Under State Law: This Limited Warranty gives you specific legal rights, and you may also have other rights that vary from state to state . FreeStyle, Libre and related brand marks are trademarks of Abbott Diabetes Care Inc . in various jurisdictions .
  • Page 73 ART38553-101_rev-A_manual.indd 137 2/1/18 2:13 PM...

Table of Contents