Freestyle LIBRE PRO Operator's Manual
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Freestyle LIBRE PRO Operator's Manual

Flash glucose monitoring system
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Operator's Manual
FLASH GLUCOSE MONITORING SYSTEM
CAUTION: Federal law restricts this device
to sale by or on the order of a physician.
944_rev-C_cover.indd 1
9/23/16 9:

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Summary of Contents for Freestyle LIBRE PRO

  • Page 1 Operator’s Manual FLASH GLUCOSE MONITORING SYSTEM CAUTION: Federal law restricts this device to sale by or on the order of a physician. 944_rev-C_cover.indd 1 9/23/16 9:...

  • Page 2: Table Of Contents

    FreeStyle Libre Pro Software . . . . . . . . . . . . . . . . . .

  • Page 3: Reader Symbols

    Reader Symbols Symbol What It Means Reader Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 View previous/next screen Maintenance and Disposal .

  • Page 4: Important Safety Information

    . evaluated . The exposure may damage the Sensor Readings from the FreeStyle Libre Pro Sensor are only made available to and may impact proper function of the device to detect patients through consultation with a health care professional .
  • Page 5 Warnings/Limitations Sensor glucose readings . The level of inaccuracy depends on the • amount of acetaminophen active in the body and may be different for Review all product information before use . • each person . Physiologic differences between the interstitial fluid and capillary blood •...

  • Page 6: Getting To Know The System

    Reader, a disposable Sensor, and FreeStyle Libre Pro • software . A single FreeStyle Libre Pro Reader can be used to gather data Select an appropriate Sensor site to help the Sensor stay attached to the from FreeStyle Libre Pro Sensors on multiple patients .

  • Page 7: Reader Kit

    Reader Kit Sensor Kit The Reader Kit includes: The Sensor Kit includes: • • • • • FreeStyle Libre Power Adapter Quick Start Guide Sensor Pack Alcohol wipe • • • Pro Reader Operator’s Manual Sensor Applicator Product insert •...

  • Page 8: Freestyle Libre Pro Software

    The Reader Home Screen provides access to starting a new Sensor, getting Sensor data, and information about the System . FreeStyle Libre Pro software can be used to create reports based on glucose readings from the most recently downloaded Sensor . The Home Screen software is compatible with most Windows and Mac operating systems .

  • Page 9: Setting Up The Reader For The First Time

    Setting up the Reader for the First Time Step Action Set the Current Time . Touch next to continue . Before using the System for the first time, the Reader must be set up . Current Time Step Action CAUTION: It is very important to set the time and date correctly for correct interpretation Press the Home Button to turn on the Reader .

  • Page 10: Using The Sensor

    (separately from the Reader) and have the same Sensor code . To prevent discomfort or skin irritation, you Check that the Sensor codes match before using FreeStyle Libre should select a different site other than the the Sensor Pack and Sensor Applicator . Sensor Sensor Pack one most recently used .
  • Page 11 Step Action Step Action Open the Sensor Pack by peeling the lid off The Sensor Applicator is prepared and ready to completely . Unscrew 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 12: Starting The Sensor

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

  • Page 13: Patient Wear

    . • Before your patient goes home, review and give them the “Living with Your FreeStyle Libre Pro Sensor” section of the insert in the Sensor Kit . Touch OK to go to the Home Screen . Sensor Working CAUTION: Intense exercise may cause the Sensor to loosen due to sweat or movement of the Sensor .

  • Page 14: Getting Sensor Data

    Reader to a computer . See Creating Reports section in the Touch Get Sensor Data . computer. 10:23pm FreeStyle Libre Pro software User’s Manual . The User’s Manual can be found in the Help Menu of Start New Get Sensor Sensor Data the software .

  • Page 15: Removing The Sensor

    Daily Graph Removing the Sensor The Sensor automatically stops working and should be removed 14 days The Daily Graph shows the Sensor glucose readings Daily Graph (mg/dL) after being started . You should also replace the Sensor if there is any by day and the Target Glucose Range that is set on irritation or discomfort at the application site or if the Reader reports a the Reader .

  • Page 16: Charging The Reader

    Charging the Reader Reader Options A fully charged Reader battery should last up to 2 weeks . The battery life You can go to the Options menu to check Sensor or System Status or Low Battery may vary depending on your usage . change settings on the Reader, like Time &...
  • Page 17 Step Action Step Action • Touch the option you want to view or change: Perform a Reader Test: The Reader Test will perform internal diagnostics and allow you to check that the display is (cont.) Check Sensor Status – Check if a Sensor is working or has showing all pixels, sounds (including both tones and ended vibrations) are working, and the touchscreen is responding...

  • Page 18: Maintenance And Disposal

    . you press the Maintenance Home Button . The FreeStyle Libre Pro Flash Glucose Monitoring System has no serviceable parts . Disposal Reader is outside Move the Reader to a This product should be disposed of in accordance with all applicable local of its operating temperature between 50 °F...

  • Page 19: Problems At The Sensor Application Site

    Problems at the Sensor Application Site Problems Starting the Sensor Problem What It May Mean What To Do Display What It May Mean What To Do The Sensor is not The site is not free 1 . Remove the Sensor . Sensor Ended You may be trying If you need to start a Sensor,...

  • Page 20: Problems Getting Sensor Data

    Problems Getting Sensor Data Display What It May Mean What To Do Display What It May Mean What To Do Sensor Starting The Sensor has Wait for the reminder to not completed check Sensor status . This Data Transfer The Reader is not Hold the Reader within starting .

  • Page 21: Reader Error Messages

    Reader error . Turn off the Reader and try about the FreeStyle Libre Pro Flash Glucose Monitoring System . Please go again . If the error reappears, to the back cover of this manual for your Customer Service phone number .

  • Page 22: System Specifications

    System Specifications Up to 14 days (glucose readings stored Sensor memory Sensor Specifications every 15 minutes) Sensor glucose assay Amperometric electrochemical sensor method Operating temperature 50 °F to 113 °F Sensor glucose reading 40 to 500 mg/dL range Sensor Applicator and Sensor Pack storage 39 °F to 77 °F temperature...
  • Page 23 . The Sensor and Reader are protected by proprietary data format, memory mapping, and cyclic redundancy check (CRC) generation and verification of data . Reader moisture Quality of Service (QoS): QoS for the FreeStyle Libre Pro Reader and Sensor wireless Keep dry protection 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 24: 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 Temperature limit Catalog number and materials that may contact bodily fluids during use . Dispose of product in accordance with all applicable local Manufacturer Serial number...

  • Page 25: Performance Characteristics

    Clinical Study Overview Glucose of GM- ±15% / ±20% / ±30% / ±40% / ±40% / Performance of the FreeStyle Libre Pro Flash Glucose Monitoring System (the System) was Level Reference ±15 mg/dL ±20 mg/dL ±30 mg/dL ±40 mg/dL ±40 mg/dL evaluated in a clinical study.
  • Page 26 Agreement with GM Glucose Levels Agreement on Day 1 against YSI Reference The accuracy of GM versus YSI reference was also assessed by calculating the percentage of System The accuracy of GM versus YSI reference on the first day of sensor wear was assessed by calculating readings that were within 15%, 20%, 30% and 40% for reference values 80 mg/dL and above, and the percentage of System readings that were within 15%, 20%, 30% and 40% for reference values 15 mg/dL, 20 mg/dL, 30 mg/dL and 40 mg/dL for values below 80 mg/dL when glucose levels are...
  • Page 27 Overall Accuracy against YSI Reference Table 4: Difference Measures by YSI Reference Glucose Levels Accuracy was measured by comparing the absolute relative difference between the System and YSI Reference reference YSI glucose values. The absolute relative difference measures the level of disagreement between the System and the reference value, but does not tell you whether the System glucose Reference Glucose Number of GM-...
  • Page 28 83.5 97.3 99.3 401-500 81.6 90.4 97.4 99.1 * Comparison to BG was performed using the FreeStyle Precision blood glucose meter. Different performance may be expected when compared to other models of blood glucose meters. ART26944_rev-C_manual.indd 50-51 9/23/16 9:19 AM...
  • Page 29 11.3 401-500 * Comparison to BG was performed using the FreeStyle Precision blood glucose meter. Different performance may be expected when compared to other models of blood glucose meters. ** For reference values ≤ 80 mg/dL, the mean and median absolute differences (mg/dL) are presented instead of mean and median absolute relative differences (%).
  • Page 30 Concurrence of System and Reference (YSI vs. GM) Table 7: Concurrence Analysis by Glucose Level The percentage of concurring glucose values (YSI vs. GM) in each glucose reference range is GM Glucose Level (mg/dL) presented for each YSI range in Table 7. For example, when the YSI glucose results are within the 121- 161- 201-...
  • Page 31 Agreement with ‘LO’ or ‘HI’ GM Reading against YSI Reference Table 9 displays the concurrence between the GM and YSI reference glucose when GM reads ‘HI’ . For example, when GM reads ‘HI’ you can expect that YSI glucose values were less than 200 mg/dL 0.0% The system reports glucose concentrations between 40 and 500 mg/dL.
  • Page 32 2117 11.4 13.8 10.6 4036 11.0 13.3 * Comparison to BG was performed using the FreeStyle Precision blood glucose meter. Different performance may be expected when compared to other models of blood glucose meters. 2919 10.2 12.3 10-13 2214 10.4 1037 ART26944_rev-C_manual.indd 58-59...
  • Page 33 90.2 96.9 99.6 1037 84.7 91.3 98.0 99.3 * Comparison to BG was performed using the FreeStyle Precision blood glucose meter. Different performance may be expected when compared to other models of blood glucose meters. ART26944_rev-C_manual.indd 61 9/23/16 9:19 AM...
  • Page 34 System Glucose Availability Precision The System is designed to generate a GM value every 15 minutes throughout the sensor wear time. Overall, 202 Precision of the System was evaluated by comparing the results from two separate sensors worn on sensors were inserted. 167 sensors produced glucose readings and are included in the analysis. There were the same subject at the same time.

  • Page 35: Electromagnetic Compatibility

    Guidance and manufacturer’s declaration – Electromagnetic Compatibility 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 36 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 37 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 Power frequency Reader: 3 A/m Reader: 3 A/m Power frequency magnetic communications equipment should (50/60 Hz)
  • Page 38 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 to fixed RF transmitters, an electromagnetic site survey should be considered.
  • Page 39 Recommended separation distances between portable For transmitters rated at a maximum output power not listed above, the recommended separation 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 40: Limited Warranty

    Operator’s Manual. Abbott’s sole obligation is to replace the Reader, free of Libre Pro reader for a full refund within 30 days of purchase. You must have proof of purchase, i.e., charge, with the same or an alternative reader as determined by Abbott in its sole discretion. Your a copy of the dated itemized purchase receipt and the original packaging to obtain this refund.
  • Page 41 944_rev-C_manual.indd 76 9/23/16 9:...

  • Page 42: Distributed By

    Customer Service: 1-855-632-5297 Monday through Friday, 8AM to 8PM Eastern Standard Time www.FreeStyleLibrePro.com FreeStyle 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 Manufacturer: ©2016 Abbott ART26944 Rev.
  • Page 43 Place Sensor Applicator over site. Push down – You have irritation or discomfort at the Sensor site. The FreeStyle Libre Pro System aids in the detection of glucose level firmly to apply Sensor. – You have any questions about your Sensor.

  • Page 44: Consult Instructions For Use

    Care Inc. in various jurisdictions. property of their respective owners. FreeStyle Libre Pro y deje de utilizarlo. Póngase en contacto con su ©2016 Abbott ART26946-001 Rev. B 09/16 ©2016 Abbott ART26946-001 Rev. B 09/16 profesional de la salud para tratar las reacciones cutáneas.

  • Page 45: Adc Confidential

    ART33738-006_rev-A.pdf 1/20/16 11:20 AM DO NOT PRINT FROM THIS FILE - FOR REFERENCE ONLY USB Cable and Power Adapter | Câble USB et adaptateur de courant | ケーブルと電源アダプタ Cable USB y adaptador de alimentación eléctrica For use with | À utiliser avec | | Para uso con: 使用対象...
  • Page 46 1 Operator’s Manual 1 Quick Start Guide FLASH GLUCOSE MONITORING SYSTEM READER Accurate, Convenient and Insightful For use with FreeStyle Libre Pro Sensor Do not use if seal is broken or missing. P150021 Amendment ADC Confidential Attachment L7B, Page 2 of 2...
  • Page 47 ART26950_rev-A.pdf 11/30/15 6:33 PM DO NOT PRINT FROM THIS FILE - FOR REFERENCE ONLY Sensor Applicator CODE XXXXXXXXXXX YYYY-MM-DD P150021 Amendment ADC Confidential Attachment L5, Page 2 of 2...
  • Page 48 ART26951_rev-A.pdf 12/1/15 12:12 PM DO NOT PRINT FROM THIS FILE - FOR REFERENCE ONLY Sensor Pack Customer Service: 1-855-632-5297 CODE XXXXXXXXXXX YYYY-MM-DD P150021 Amendment ADC Confidential Attachment L4, Page 2 of 2...
  • Page 49 Dispose AREA product of USA. of product in accordance with all FreeStyle and related brand marks are trademarks of Abbott Diabetes applicable local regulations. Care Inc. in various jurisdictions. Other trademarks are the property of their respective owners. ©2016 Abbott Manufacturer Patent: https://www.abbott.com/patents...

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