Abbott FreeStyle LibrePro Operator's Manual
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Abbott FreeStyle LibrePro Operator's Manual

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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.

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Summary of Contents for Abbott FreeStyle LibrePro

  • 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.

  • Page 2: Table Of Contents

    Contents Reader Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Important Safety Information .
  • Page 3 Reader Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Maintenance and Disposal .

  • Page 4: Reader Symbols

    Reader Symbols Symbol What It Means View previous/next screen Options Low battery Battery charging Confirm Sensor reminder Communication strength Data to report...

  • Page 5: Important Safety Information

    Important Safety Information Indications for Use The FreeStyle Libre Pro Flash Glucose Monitoring System is a professional continuous glucose monitoring (CGM) device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes . The System is intended for use by health care professionals and requires a prescription .

  • Page 6: Contraindications

    Contraindications The FreeStyle Libre Pro Flash Glucose Monitoring System must be removed prior to Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment . The effect of MRI, CT scans, or diathermy on the performance of the System has not been evaluated .
  • Page 7 Warnings/Limitations • Review all product information before use . • Physiologic differences between the interstitial fluid and capillary blood may result in differences in glucose readings . Differences in glucose readings between interstitial fluid and capillary blood may be observed during times of rapid change in blood glucose, such as after eating, dosing insulin, or exercising .
  • Page 8 • Take standard precautions for transmission of blood borne pathogens to avoid contamination . • The Reader should be cleaned between patients . • If a Sensor breaks inside a patient, remove with tweezers, treat any medical complications and call Customer Service . •...
  • Page 9 • Change the application site for the next Sensor application to prevent discomfort or skin irritation . • Select an appropriate Sensor site to help the Sensor stay attached to the body and prevent discomfort or skin irritation . Avoid areas with scars, moles, stretch marks, or lumps .

  • Page 10: Getting To Know The System

    Getting to Know the System The FreeStyle Libre Pro Flash Glucose Monitoring System has three main parts: a handheld Reader, a disposable Sensor, and FreeStyle Libre Pro software . A single FreeStyle Libre Pro Reader can be used to gather data from FreeStyle Libre Pro Sensors on multiple patients .

  • Page 11: Reader Kit

    Reader Kit The Reader Kit includes: • • • FreeStyle Libre Power Adapter Quick Start Guide • Pro Reader Operator’s Manual • USB Cable Touchscreen USB Port Used to charge the Reader and connect it to a computer. Home Button Turns the Reader on/o and takes you to the Home Screen from any...

  • Page 12: Sensor Kit

    Sensor Kit The Sensor Kit includes: • • Sensor Pack Alcohol wipe • • Sensor Applicator Product insert Sensor Pack Sensor Applicator Used with the Sensor Applicator to Applies the Sensor to the patient’s body . prepare the Sensor for use . The Sensor measures and stores glucose readings when worn on the body .

  • Page 13: Home Screen

    The Reader Home Screen provides access to starting a new Sensor, getting Sensor data, and information about the System . Home Screen Battery Level Time Battery charge remaining. Current time set on the Reader. 10:23pm Options Touch to view or change the Reader’s options.

  • Page 14: Freestyle Libre Pro Software

    FreeStyle Libre Pro Software FreeStyle Libre Pro software can be used to create reports based on glucose readings from the most recently downloaded Sensor . The software is compatible with most Windows and Mac operating systems . Go to www .FreeStyleLibrePro .com and follow onscreen instructions to download and install the software .

  • Page 15: Setting Up The Reader For The First Time

    Setting up the Reader for the First Time 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 . If prompted, use the touchscreen to select your preferred language for the Reader .
  • Page 16 Step Action Set the Current Time . Touch next to continue . Current Time CAUTION: It is very important to set the time and date correctly for correct interpretation of Sensor data . back next Set the Target Glucose Range . Touch next to Target Glucose Range continue .

  • Page 17: Using The Sensor

    Using the Sensor After you assemble and apply the Sensor to your patient’s body, start the Sensor with the Reader and confirm it is working . The Sensor stores glucose readings every 15 minutes for up to 14 days . The first reading is stored 1 hour after the Sensor is successfully started .

  • Page 18: Applying The Sensor

    Applying the Sensor Action Step Apply Sensors only on the back of your patient’s upper arm . Avoid areas with scars, moles, stretch marks, or lumps . Select an area of skin that generally stays flat during normal daily activities (no bending or folding) .
  • Page 19 Action Step Open the Sensor Pack by peeling the lid off completely . Unscrew cap from the Sensor Applicator and set the cap aside . CAUTION: Do NOT use if the Sensor Pack or the Sensor Applicator seem to be damaged or already opened .
  • Page 20 Action Step The Sensor Applicator is prepared and ready to apply the Sensor . CAUTION: The Sensor Applicator now contains a needle . Do NOT touch inside the Sensor Applicator or put it back into the Sensor Pack . Place the Sensor Applicator over the prepared site and push down firmly to apply the Sensor to the body .
  • Page 21 Action Step Gently pull the Sensor Applicator away from the body . The Sensor should now be attached to the skin . Sensor Note: Applying the Sensor may cause bruising or bleeding . If there is bleeding that does not stop, remove the Sensor, and apply a new one at a different site .

  • Page 22: Starting The Sensor

    Starting the Sensor Action Step Press the Home Button to turn on the Reader . Touch Start New Sensor . 10:23pm Start New Get Sensor Sensor Data Hold the Reader within 1 .5 inches (4 cm) of the Sensor to start it . If sounds are turned on, the Reader beeps when the Sensor has been started .
  • Page 23 Step Action When prompted, touch yes to check the Sensor Reminder status . Hold the Reader within 1 .5 inches (4 cm) of the Sensor to verify Sensor is working . Check Sensor Status? Touch OK to go to the Home Screen . Sensor Working Sensor can be used for up to 14 more days.

  • Page 24: Patient Wear

    Patient Wear The Sensor stores your patient’s glucose readings every 15 minutes for up to 14 days . The first reading is stored 1 hour after the Sensor is successfully started . IMPORTANT: • The Sensor should not be worn for more than 14 days . •...

  • Page 25: Getting Sensor Data

    Getting Sensor Data Data can be downloaded at anytime from Sensors that are on or off the body . Step Action Press the Home Button to turn on the Reader . Touch Get Sensor Data . 10:23pm Start New Get Sensor Sensor Data Hold the Reader within 1 .5 inches (4 cm) of the...
  • Page 26 Step Action The Reader will indicate how many days of Sensor Data Received Sensor wear are left, if any . Touch view to Days Recorded view the daily graph . Touch next . For more information about the daily graph, see Daily Sensor can be used for up to 7 more days.
  • Page 27 Daily Graph The Daily Graph shows the Sensor glucose readings Daily Graph (mg/dL) by day and the Target Glucose Range that is set on the Reader . You can change the target glucose range by touching the Options symbol on the Home Screen and selecting Target Range .

  • Page 28: Removing The Sensor

    Removing the Sensor The Sensor automatically stops working and should be removed 14 days after being started . You should also replace the Sensor if there is any irritation or discomfort at the application site or if the Reader reports a problem with the Sensor currently in use .

  • Page 29: Charging The Reader

    Charging the Reader A fully charged Reader battery should last up to 2 weeks . The battery life Low Battery may vary depending on your usage . Please charge the Reader to continue using it. Plug the included USB cable into an electrical outlet using the included power adapter .

  • Page 30: Reader Options

    Reader Options You can go to the Options menu to check Sensor or System Status or change settings on the Reader, like Time & Date or Sounds . Action Step To get to the Options menu, touch the Options 10:23pm symbol on the Home Screen .
  • Page 31 Action Step Touch the option you want to view or change: Check Sensor Status – Check if a Sensor is working or has ended Target Range – Set range displayed on Reader Daily Glucose graph Sounds – Set tones and vibrations Time &...
  • Page 32 Action Step • Perform a Reader Test: The Reader Test will perform internal diagnostics and allow you to check that the display is (cont.) showing all pixels, sounds (including both tones and vibrations) are working, and the touchscreen is responding when touched •...

  • Page 33: Maintenance And Disposal

    Maintenance and Disposal Cleaning You may clean the Reader using a damp cloth . Gently wipe the exterior of the Reader and allow to air dry . CAUTION: Do NOT place the Reader in water or other liquids . Avoid getting dust, dirt, water, or any other substance in the USB port .

  • Page 34: Troubleshooting

    Troubleshooting This section lists problems or observations that may occur, the possible cause(s), and recommended actions . If the Reader experiences an error, a message will appear on the screen with directions to resolve the error . Reader Does Not Power On Problem What It May Mean What To Do...

  • Page 35: Problems At The Sensor Application Site

    Problems at the Sensor Application Site Problem What It May Mean What To Do The Sensor is not The site is not free 1 . Remove the Sensor . sticking to the of dirt, oil, hair, or 2 . Consider shaving and/or patient’s skin .

  • Page 36: Problems Starting The Sensor

    Problems Starting the Sensor Display What It May Mean What To Do Sensor Ended You may be trying If you need to start a Sensor, to start a used then apply and start a new Sensor . one . Otherwise, return to the Home Screen to get Sensor data .

  • Page 37: Problems Getting Sensor Data

    Problems Getting Sensor Data Display What It May Mean What To Do Data Transfer The Reader is not Hold the Reader within Error held close enough 1 .5 inches (4 cm) of the or long enough to Sensor for up to 5 seconds . the Sensor .
  • Page 38 Display What It May Mean What To Do Sensor Starting The Sensor has Wait for the reminder to not completed check Sensor status . This starting . will take approximately 2 minutes . No Data There is no data Sensor data is usually Available available to available for download...

  • Page 39: Reader Error Messages

    Display What It May Mean What To Do Data to Report You have not yet To create reports from the generated reports data already on the Reader, from the data connect the Reader to a already on the computer . Or, to overwrite Reader .

  • Page 40: Perform A Reader Test

    Perform a Reader Test If you think the Reader is not working properly, you System Status can check the Reader by performing a Reader Test . System Info Touch the Options symbol from the Home Reader Test Screen, select System Status and then select Event Log Reader Test .

  • Page 41: System Specifications

    System Specifications Sensor Specifications Sensor glucose assay Amperometric electrochemical sensor method Sensor glucose reading 40 to 500 mg/dL range Sensor size 5 mm height and 35 mm diameter Sensor weight 5 grams Sensor power source One silver oxide battery Sensor wear period Up to 14 days...
  • Page 42 Up to 14 days (glucose readings stored Sensor memory every 15 minutes) Operating temperature 50 °F to 113 °F Sensor Applicator and Sensor Pack storage 39 °F to 77 °F temperature Operating and storage 10-90%, non-condensing relative humidity IP27: Can withstand immersion into Sensor water resistance 3 ft (one meter) of water for up to 30 minutes...
  • Page 43 Reader Specifications Reader size 95 mm x 60 mm x 16 mm Reader weight 65 grams Reader power source One lithium-ion rechargeable battery Reader battery life 2 weeks of typical use Reader Sensor memory 1 Sensor Reader operating 50 °F to 113 °F temperature Reader storage -4 °F to 140 °F...
  • Page 44 System must only be used with Requirements EN60950-1 rated computers Mean service life 3 years of typical use Abbott Diabetes Care PRT25611 Power Adapter Operating temperature: 50 °F to 104 °F Abbott Diabetes Care PRT21373 USB Cable Length: 37 inches (94 cm)

  • Page 45: Labeling Symbols

    Labeling Symbols Consult instructions for Use-by date Temperature limit Catalog number Manufacturer Serial number Do not use if package is Batch code damaged Type BF applied part Keep dry Sensor code Non-ionizing radiation CODE Do not re-use Caution MR unsafe Humidity limitation FCC Declaration of Sterilized using...
  • Page 46 CAUTION: Federal law restricts this device to sale by or on the order of a physician . 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 regulations .

  • Page 47: Performance Characteristics

    Performance Characteristics Clinical Study Overview Performance of the FreeStyle Libre Pro Flash Glucose Monitoring System (the System) was evaluated in a clinical study. The study was conducted in 4 centers; a total of 72 subjects with diabetes (81.9% Type 1, 18.1% Type 2) aged eighteen and older were included in the study; all subjects required insulin administration either by an insulin pump or via multiple daily injections to manage their diabetes.
  • Page 48 Table 1: Number and Percent of Results within YSI Reference Number Within Within Within Within Outside Glucose of GM- ±15% / ±20% / ±30% / ±40% / ±40% / Level Reference ±15 mg/dL ±20 mg/dL ±30 mg/dL ±40 mg/dL ±40 mg/dL (mg/dL) Pairs Overall...
  • Page 49 Agreement with GM Glucose Levels The accuracy of GM versus YSI reference was also assessed by calculating the percentage of System readings that were within 15%, 20%, 30% and 40% for reference values 80 mg/dL and above, and 15 mg/dL, 20 mg/dL, 30 mg/dL and 40 mg/dL for values below 80 mg/dL when glucose levels are assigned using the GM readings.
  • Page 50 Agreement on Day 1 against YSI Reference The accuracy of GM versus YSI reference on the first day of sensor wear was assessed by calculating the percentage of System readings that were within 15%, 20%, 30% and 40% for reference values 80 mg/dL and above, and 15 mg/dL, 20 mg/dL, 30 mg/dL and 40 mg/dL for values below 80 mg/dL by hourly intervals.
  • Page 51 Overall Accuracy against YSI Reference Accuracy was measured by comparing the absolute relative difference between the System and 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 value was, on average, higher or lower than the reference glucose value.
  • Page 52 Table 4: Difference Measures by YSI Reference Glucose Levels YSI Reference Reference Glucose Number of GM- Median Absolute Mean Absolute Relative Level (mg/dL) Reference Pairs Relative Difference (%) Difference (%) Overall 12323 10.1 12.3 40-50* 14.2 15.8 51-80* 12.5 15.5 81-180 7373 10.7...
  • Page 53 Agreement with BG Levels Agreement between the System and capillary FreeStyle Precision blood glucose values (BG) was characterized by using paired System Glucose Measurements (GM) and BG reference. The accuracy of GM versus BG reference was assessed by calculating the percentage of System readings that were within 15%, 20%, 30% and 40% for reference values 80 mg/dL and above, and 15 mg/dL, 20 mg/dL, 30 mg/dL and 40 mg/dL for values below 80 mg/dL.
  • Page 54 Table 5: Number and Percent of Results within BG Reference* Number Within Within Within Within Outside Glucose of GM- ±15% / ±20% / ±30% / ±40% / ±40% / Level Reference ±15 mg/dL ±20 mg/dL ±30 mg/dL ±40 mg/dL ±40 mg/dL (mg/dL) Pairs Overall...
  • Page 55 Overall Accuracy against BG Reference Accuracy was measured by comparing the absolute relative difference between the System and reference BG 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 value was, on average, higher or lower than the reference glucose value.
  • Page 56 Table 6: Difference Measures by BG Reference Levels* BG Reference Reference Glucose Number of GM- Median Absolute Mean Absolute Relative Level (mg/dL) Reference Pairs Relative Difference (%) Difference (%) Overall 11918 11.1 13.9 40-50** 13.5 19.1 51-80** 10.0 12.6 81-180 6397 10.9 13.5...
  • Page 57 Concurrence of System and Reference (YSI vs. GM) The percentage of concurring glucose values (YSI vs. GM) in each glucose reference range is presented for each YSI range in Table 7. For example, when the YSI glucose results are within the 81 to 120 mg/dL range, you can expect the GM values were less than 40 mg/dL 0.2% of the time, between 40 and 60 mg/dL 1.8% of the time, between 61 and 80 mg/dL 9.0% of the time, between 81 and 120 mg/dL 61.4% of the time, between 121 and 160 mg/dL 26.7% of the time, between 161...
  • Page 58 Table 7: Concurrence Analysis by Glucose Level GM Glucose Level (mg/dL) 121- 161- 201- 251- 301- 351- 401- (mg/dL) <40* 40-60 61-80 >500* <40 20.0 80.0 40-60 26.4 60.0 11.8 61-80 11.1 42.9 43.6 81-120 61.4 26.7 0.0 2472 121-160 0.0 12.4 60.8 25.0 0.0 3338 161-200 0.0...
  • Page 59 Agreement with ‘LO’ or ‘HI’ GM Reading against YSI Reference The system reports glucose concentrations between 40 and 500 mg/dL. When the system determines that glucose level is below 40 mg/dL, it will report as ‘LO’ . When the system determines that glucose level is above 500 mg/dL, it will report as ‘HI’...
  • Page 60 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% of the time, between 200 and 300 mg/dL 0.0% of the time, between 301 and 400 mg/dL 0.0% of the time, between 401 and 500 mg/dL 100% of the time, and above 500 mg/dL 0.0% of the time.
  • Page 61 Accuracy by Day of Wear The sensor can be worn for up to 14 days. To show sensor performance over time, the absolute relative difference between the System and reference YSI glucose and capillary blood glucose values (BG) over the 14 day wear is presented in Table 10 and Table 11. The accuracy of GM versus YSI reference and BG reference was assessed by calculating the percentage of System readings that were within 15%, 20%, 30% and 40% for reference values 80 mg/dL and above, and 15 mg/dL, 20 mg/dL, 30 mg/dL and 40 mg/dL for values below 80 mg/dL.
  • Page 62 Table 11: Difference Measures by Day (BG Reference*) Reference Number of GM- Median Absolute Mean Absolute Reference Pairs Relative Difference (%) Relative Difference (%) 1087 11.9 15.0 4005 11.9 14.6 3432 11.7 14.5 10-13 2841 12.5 10.6 * 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.
  • Page 63 Table 12: Number and Percent of Results within YSI Reference Number Within Within Within Within Outside of GM- ±15% / ±20% / ±30% / ±40% / ±40% / Reference ±15 mg/dL ±20 mg/dL ±30 mg/dL ±40 mg/dL ±40 mg/dL Pairs 2117 64.5 77.7...
  • Page 64 Table 13: Number and Percent of Results within BG Reference* Number Within Within Within Within Outside of GM- ±15% / ±20% / ±30% / ±40% / ±40% / Reference ±15 mg/dL ±20 mg/dL ±30 mg/dL ±40 mg/dL ±40 mg/dL Pairs 1087 61.8 74.1...
  • Page 65 System Glucose Availability The System is designed to generate a GM value every 15 minutes throughout the sensor wear time. Overall, 202 sensors were inserted. 167 sensors produced glucose readings and are included in the analysis. There were 35 sensors that failed at insertion (i.e. no glucose reading generated) and are not included in the analysis. There were 62.5% of primary sensors that worked for 14 days.
  • Page 66 Precision Precision of the System was evaluated by comparing the results from two separate sensors worn on the same subject at the same time. Data from two sensors worn at the same time for 72 subjects provided 49,806 pairs of GM measurements. The mean PARD during the study was 8.6% with a coefficient of variation of 6.1%.

  • Page 67: Electromagnetic Compatibility

    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 may result in increased EMISSIONS or decreased IMMUNITY of the System.

  • Page 68: Electromagnetic Emissions

    Guidance and manufacturer’s declaration – electromagnetic emissions 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. Emissions test Compliance RF emissions CISPR 11 Group 1 RF emissions CISPR 11...
  • Page 69 Guidance and manufacturer’s declaration – electromagnetic immunity 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. IMMUNITY IEC 60601 Compliance Electromagnetic test...
  • Page 70 IMMUNITY IEC 60601 Compliance Electromagnetic test test level Level environment – guidance Surge ±1 kV ±1 kV Mains power quality should be that differential differential of a typical commercial or hospital IEC 61000-4-5 mode mode environment. ±2 kV common ±2 kV common mode mode <5 % U...
  • Page 71 IMMUNITY IEC 60601 Compliance Electromagnetic test test level Level environment – guidance Power frequency 30 A/m 30 A/m Power frequency magnetic (50/60 Hz) fields should be at levels magnetic field characteristic of a typical location in a typical commercial or hospital IEC 61000-4-8 environment.
  • Page 72 IMMUNITY IEC 60601 Compliance Electromagnetic test test level Level environment – guidance Conducted RF 6 Vrms 6 Vrms Portable and mobile RF communications equipment should IEC 61000-4-6 150 kHz to be used no closer to any part of the 80 MHz System, including cables, than the recommended separation distance calculated from the equation...
  • Page 73 IMMUNITY IEC 60601 Compliance Electromagnetic test test level Level environment – guidance Recommended separation Radiated RF 10 V/m 10 V/m distance IEC 61000-4-3 80 MHz to 2.7 GHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz 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 meters (m).
  • Page 74 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 cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the System is used exceeds the applicable RF compliance level above, the System should be observed to verify normal operation.
  • Page 75 Recommended separation distances between portable and mobile RF communications equipment and the System The System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the System as recommended below, according to the maximum output power of the communications equipment.
  • Page 76 NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Font License ©2013 Abbott Licensed under the Apache License, Version 2 .0 (the “License”); you may not use this file except in compliance with the License . You may obtain a copy of the License at: http://www .apache .org/licenses/LICENSE-2 .0...

  • Page 77: Limited Warranty

    Operator’s Manual. Abbott’s sole obligation is to replace the Reader, free of charge, with the same or an alternative reader as determined by Abbott in its sole discretion. Your replacement may be a different model or type. This Limited Warranty covers only the Reader, does not cover disposable accessories, extends only to the original purchaser, and is not assignable or transferable.
  • Page 78 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 and related brand marks are trademarks of Abbott Diabetes Care Inc. LIMITED WARRANTY SERVICES If you do not agree to the terms and conditions of this Limited Warranty, you may return the FreeStyle Libre Pro reader for a full refund within 30 days of purchase.
  • Page 79 Customer Service: 1-855-632-5297 Monday through Friday, 8AM to 8PM Eastern Standard Time www.FreeStyleLibrePro.com FreeStyle Libre Pro 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:...

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