Abbott FreeStyle Libre 2 User Manual

Flash glucose monitoring system

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4.6"

Distributed by:

Abbott Diabetes Care Inc.

1360 South Loop Road

Alameda, CA 94502 USA

Customer Service: 1-855-632-8658

7 Days a Week from 8AM to 8PM Eastern Standard Time

www.FreeStyleLibre.com

The circular shape of the sensor housing, FreeStyle, Libre, and related brand marks are

marks of Abbott. Other trademarks are the property of their respective owners.

Patent: https://www.abbott.com/patents

DOC40703_rev-K_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

3/19/21 9:14 AM

Table of Contents

Summary of Contents for Abbott FreeStyle Libre 2

Page 1 7 Days a Week from 8AM to 8PM Eastern Standard Time www.FreeStyleLibre.com The circular shape of the sensor housing, FreeStyle, Libre, and related brand marks are marks of Abbott. 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” DOC40703_rev-K_cover.indd 3-4 DOC40703_rev-K_cover.indd 3-4 3/19/21 9:14 AM 3/19/21 9:14 AM .224”...
Page 3 WARNING: Before you use the FreeStyle Libre 2 System, review all the product instructions and the Interactive Tutorial. The Quick Reference Guide and Interactive Tutorial give you quick access to important aspects and limitations of the System. The User’s Manual includes all safety information and instructions for use.
Page 4: Table Of Contents
Contents Important Safety Information......1 Indications For Use ........1 Compatible Devices, Apps, and Software .
Page 5 Alarms..........56 Living With Your System.
Page 6: Important Safety Information
FreeStyle Libre 2 Sensor please go to: https://freestylelibre.us/support/ overview.html The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability Use of the Sensor with devices, apps, and software that are not listed may indicated for the management of diabetes in persons age 4 and older.
Page 7: Warnings
• To prevent missed alarms, make sure the Reader has sufficient charge WARNINGS: and that sound and/or vibration are turned on. • Do not ignore symptoms that may be due to low or high blood • Alarms you receive do not include your glucose reading so you must glucose: If you are experiencing symptoms that are not consistent scan your Sensor to check your glucose.
Page 8 performing as intended. Contact Customer Service if you receive a What should you know about wearing a Sensor: Replace Sensor message before the end of the 14 day wear period. • Wash application site on the back of your upper arm using a plain Customer Service is available at 1-855-632-8658 7 Days a Week from soap, dry, and then clean with an alcohol wipe.
Page 9 • Not suitable for re-sterilization. Further exposure to irradiation may Do NOT use if the Reader appears to be damaged due to risk of cause unreliable low results. electric shock and/or no results. • If a Sensor breaks inside your body, call your health care professional. What to know before you Apply the Sensor: •...
Page 10 • Clean hands prior to Sensor handling/insertion to help prevent What to know about X-Rays: infection. • The Sensor should be removed prior to exposing it to an X-ray • Change the application site for the next Sensor application to prevent machine.
Page 11: Interfering Substances
Taking ascorbic acid (vitamin C) supplements while wearing the Sensor • The FreeStyle Libre 2 Reader has a built-in blood glucose meter may falsely raise Sensor glucose readings. Taking more than 500 mg of that is designed to be used only with FreeStyle Precision Neo blood...
Page 12: Reader Symbols
Reader Symbols Symbol What It Means When you see this symbol during the first 12 hours Symbol What It Means of wearing a Sensor, confirm Sensor glucose readings with a blood glucose test before making treatment Active Sensor decisions. Notes Direction your glucose is going.
Page 13: Getting To Know Your System
• Before you use your System, review all the product instructions and the Interactive Tutorial. The Quick Reference Guide and Interactive The FreeStyle Libre 2 System (“System”) has two main parts: a handheld Tutorial give you quick access to important aspects and limitations Reader and a disposable Sensor that you wear on your body.
Page 14: Reader Kit
14 days. and lancets. These items are not included in the Reader kit and must Sensor be obtained separately from your FreeStyle Libre 2 System provider Measures your glucose while on your (pharmacy or mail order supplier).
Page 15 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 16: Freestyle Libre Software
Reader. Touch OK to blood glucose test results, and other data uploaded from the continue. FreeStyle Libre 2 Flash Glucose Monitoring System, in support of an effective diabetes health management program. Note: Use the pad of your finger. Do NOT use your fingernail or any other object on the screen.
Page 17 Step Action Step Action Set the Current Date using the arrows on the The Reader now displays important information about 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 2020 the Glucose Reading screen.
Page 18: Using Your Sensor
Applying Your Sensor Using Your Sensor Action Step CAUTIONS: Apply Sensors only on the back of your upper • The Sensor Pack and Sensor Applicator FreeStyle Libr arm. If placed in other areas, the Sensor may are packaged as a set (separately from Sensor Pack not function properly and could give inaccurate the Reader) and have the same Sensor...
Page 19 Action Action Step 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 contains a needle.
Page 20: 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 21: Checking Your Glucose
Checking Your Glucose Step Action Step Action The Reader displays your current glucose reading Glucose Going along with your glucose graph and an arrow High Turn the Reader on by pressing indicating the direction your glucose is going. 10:23pm the Home Button or touch Ends in 14 days Check Glucose from the Home 10am...
Page 22 The Glucose Trend Arrow gives you an indication of the direction your Sensor Glucose Readings glucose is going. Glucose Going Glucose is rising quickly Glucose Trend Arrow (more than 2 mg/dL per minute) Glucose is rising (between 1 and 2 mg/dL per minute) Current Glucose Glucose is changing slowly Target Glucose Range...
Page 23 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 24: Making Treatment Decisions
Making Treatment Decisions – Getting Started Making Treatment Decisions Before you start using the System for treatment decisions, make sure Work with your health care professional to put together a plan for you have a good understanding of how the System works for your body. managing your diabetes that includes when to use the System information Continue to use your blood glucose meter for treatment decisions for making treatment decisions.
Page 25 • • Scan your Sensor often to see how carbs, medication, exercise, illness, or Sensor glucose values, which are based on interstitial fluid glucose stress levels impact your Sensor glucose readings. The information you levels, can be different from blood glucose levels (fingersticks), get can help you figure out why your glucose sometimes goes too high particularly during times when your blood glucose is changing quickly.
Page 26 Symptoms Don’t Match Readings When you see the symbol during the first 12 hours of wearing a There may be times when your symptoms don’t match your Sensor Sensor glucose readings. For example, you are feeling shaky, sweaty, and dizzy– During the first 12 hours of Sensor wear the symbol will display, and symptoms you generally get when you have low glucose, but your...
Page 27: Using Your Glucose Reading To Make A Treatment Decision
Using Your Glucose Reading to Make a Treatment This table provides some information on how you can factor the Glucose Trend Arrow into your treatment decisions. Remember that you should Decision never make a treatment decision based on the Glucose Trend Arrow alone. After you scan your Sensor, use all of the information on the screen when deciding what to do or what treatment decision Treatment Decision Considerations...
Page 28 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) Treat low glucose If you are about to eat, If you are about to eat,...
Page 29 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) Treat low glucose If you are about to eat, If you are about to eat,...
Page 30 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 31 What you see What it means What you see What it means In the afternoon: Between meals, your current glucose is Before lunch: When you checked your glucose before lunch, 72 mg/dL. The Glucose Going Low message it was 90 mg/dL and rising. Before eating lunch, 12:00pm Glucose Going Ends in 3 days...
Page 32 Other considerations What you see What it means Deciding how much rapid-acting insulin to take for different meals and Before dinner: Before dinner, your current glucose is situations can be difficult. Work with your health care professional to 134 mg/dL. The graph shows that your glucose discuss different situations and what might work best for you.
Page 33: Alarms
Bedtime Alarms • How often do you check your glucose before bed? When in range of the Reader, your Sensor automatically communicates • What do you consider a safe bedtime glucose? with the Reader to give you Low and High Glucose Alarms. These alarms •...
Page 34 IMPORTANT: How to prevent missed alarms • Alarms must be kept on for you to receive them and you should IMPORTANT: What to know about glucose alarms ensure that your Reader is within 20 feet of you at all times. The •...
Page 35: Setting Alarms
Setting Alarms Step Action Work with your health care professional to determine your alarm settings. Select the alarm you want to set or turn off. Change Alarm Settings Step Action Low Glucose Alarm CAUTION: If alarms are turned off, you will From the Home screen, touch the Settings High Glucose Alarm 10:23pm...
Page 36 Alarm How to Set Alarm How to Set High The High Glucose Alarm is on by default. The Low Glucose Alarm is on by default. Glucose The alarm level is initially set to Glucose High Glucose Alarm The alarm level is initially set to Alarm Low Glucose Alarm 240 mg/dL.
Page 37: Setting Alarm Sounds
Setting Alarm Sounds Action Step Step Action When you are finished setting your alarms, Change Alarm Settings touch OK. The Alarms Settings screen now From the Home screen, touch the 10:23pm Low Glucose Alarm shows your current alarm settings. Touch OK Ends in 14 days Settings symbol .
Page 38: 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 20 The Low Glucose Alarm notifies you if your minutes and you are not receiving Low or High Low Glucose Alarm glucose drops below the level you set.
Page 39: Adding Notes
Adding Notes Step Action 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 Insulin to the right of the note.
Page 40: Reviewing Your History
Reviewing Your History Step Action 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 41: 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 or Logbook...
Page 42: 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 43: 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 Pull up the edge of the adhesive that keeps your irritation or discomfort at the application site or if the Reader reports a Sensor attached to your skin.
Page 44: Using Reminders
Action Using Reminders Step 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. You can also set a reminder to remind you to check your alarm settings if you have disabled your alarms temporarily.
Page 45: Using The Reader's Built-In Meter
Intended Use blood glucose test as they contain important information. They The FreeStyle Libre 2 Reader’s built-in meter is for use outside the body also let you know how to store and handle the test strips and give only (in vitro diagnostic use) in the quantitative measurement of glucose you information about sample types.
Page 46 IMPORTANT: (cont.) IMPORTANT: (cont.) • Inaccurate test strip results may occur in severely hypotensive • Do not put urine on the test strip. individuals or patients in shock. • Do not use expired test strips as they may cause inaccurate results. •...
Page 47: 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 expiration date. Do not use expired test are wearing a Sensor or not. Be sure to read the test strip instructions for strips as they may give inaccurate results.
Page 48 Step Action Step Action Note: Use your lancing device to obtain a blood drop Apply Blood (cont.) and apply blood to the white area at the end • 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 49 IMPORTANT: The built-in meter displays results from Display What To Do 20 - 500 mg/dL. Low or high blood glucose results can If your glucose is higher than 240 mg/dL or lower indicate a potentially serious medical condition. Low Glucose than 70 mg/dL, you will see a message on the The normal glucose level for a non-diabetic adult is below 100 mg/dL screen.
Page 50: Control Solution Testing
Replace the cap securely on the bottle immediately after use. • Do NOT add water or other liquid to the control solution. • Contact your FreeStyle Libre 2 System provider (pharmacy or mail order supplier) for how to obtain control solution. DOC40703_rev-K_manual.indd 89-90 DOC40703_rev-K_manual.indd 89-90...
Page 51 Action Step Action Step Insert the test strip with the three black lines From the Home Screen, touch the Settings 10:23pm Ends in 14 days facing up. Push the strip until it stops. symbol . Scroll down using the arrow and touch Control Solution Test.
Page 52 Step Action Control Solution Results 10:23pm Compare the control solution result to the range You will see a butterfly on the screen while you printed on the test strip instructions for use. The wait for the result. Do not remove the test strip (cont.) result on your screen should be in this range.
Page 53: Charging The Reader
Changing the Reader Settings Charging the Reader You can go to the Settings menu to change many settings on the Reader, A fully charged Reader battery should last up to 4 days. Your battery life may vary depending on your usage. A Low Battery message like alarm settings, sound &...
Page 54 Step Action Step Action • Touch the setting you want to change: View Event Logs: A list of events recorded by the Reader, which may be used by Customer Service to help Alarms – See Alarms section for information on setting alarms (cont.) troubleshoot your System Sound &...
Page 55: Living With Your System
Activity What You Need To Know Living With Your System Traveling by Air You may use your System while on an aircraft, Your System can be used during a wide variety of activities. following any requests from the flight crew. Activity What You Need To Know •...
Page 56: Maintenance And Disposal
Activity What You Need To Know Maintenance and Disposal Traveling by Air • The System can be exposed to common Cleaning and Disinfecting the Reader electrostatic (ESD) and electromagnetic (cont.) Cleaning and disinfecting your Reader is important to prevent the spread interference (EMI), including airport metal of infectious diseases.
Page 57 This device is not intended for use with multiple patients in health care or To clean and disinfect your Reader, you will need Clorox Healthcare Bleach Germicidal Wipes, EPA Reg. #67619-12. assisted-use settings such as hospitals, physician offices, or long-term care facilities because it has not been cleared by FDA for use in these settings, These disinfectant wipes contain a 0.55% Sodium Hypochlorite (NaOCl) including for routine assisted testing or as part of glycemic control...
Page 58 Step Action IMPORTANT: If you require assistance or if you notice any signs of deterioration on the Reader (such as clouding or crazing on the For disinfection, use a second bleach wipe to wipe all outside display of the Reader, corroding or eroding of the plastic housing, or surfaces of the Reader until they are wet.
Page 59: 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 The Sensor is The site is not free 1.
Page 60: Problems Starting Your Sensor Or Receiving Sensor Readings
Problems Starting Your Sensor or Receiving Sensor Display What It May Mean What To Do Readings Signal Loss Sensor has not Make sure the Reader is within Display What It May Mean What To Do Alarm automatically 20 feet of the Sensor. Try communicated with scanning the Sensor to get a New Sensor...
Page 61 Display What It May Mean What To Do Display What It May Mean What To Do Sensor Error The System is Scan again after the duration Sensor The Sensor was Your Reader can only be used unable to provide a specified in the message.
Page 62: 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 turned Touch the Settings symbol glucose...
Page 63: 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 64 Error Error What It May Mean What To Do What It May Mean What To Do Message Message Test strip may be 1. Check that you are using Blood was applied 1. Review the testing damaged, used, or the correct test strip for to the test strip too instructions.
Page 65: Problems Checking Your Blood Glucose
Problems Checking Your Blood Glucose Problem What It May Mean What To Do Problem What It May Mean What To Do The test Blood sample is too 1. See test strip instructions does not small. for use for re-application The Reader Test strip is not 1.
Page 66: Perform A Reader Test
Perform a Reader Test System Speciﬁcations If you think the Reader is not working properly, you See test strip and control solution instructions for use for additional System Status can check the Reader by performing a Reader Test. specifications. System Info Touch the Settings symbol from the Home Sensor Speciﬁcations...
Page 67 8 hours (glucose readings stored every Reader Speciﬁcations Sensor memory 15 minutes) Blood glucose assay 20 to 500 mg/dL Sensor transmission range 20 feet (6 meters) unobstructed range Reader size 95 mm x 60 mm x 16 mm Operating temperature 50 °F to 113 °F Reader weight 65 grams...
Page 68 3 years of typical use activated the Sensor. Quality of Service (QoS): QoS for the FreeStyle Libre 2 Reader and Sensor wireless communications The Reader has a mean use life of using NFC is assured within the effective range of 4 cm between the Sensor and Reader that is...
Page 69: Labeling Symbols
20 minutes, the Reader alarms the user if the alarm is turned on. If connection is lost between Labeling Symbols the Sensor and the Reader, up to 8 hours of glucose results can be retrieved by performing a scan with the Reader. The Reader is designed to only accept radio frequency (RF) communications from Consult instructions for recognized and paired Sensors.
Page 70: Performance Characteristics
Two studies were conducted in the United States (US) to evaluate the performance, safety, CAUTION: Federal law restricts this device to sale by or on effectiveness, and precision of the FreeStyle Libre 2 Flash Glucose Monitoring System (System). the order of a physician.
Page 71 Table 1a: Overall Accuracy to YSI manipulated per the study protocol to raise or lower glucose. This was done to assess performance of the System over the range that the System measures glucose (40 – 400 mg/dL). 48 subjects were Percent analyzed during the beginning of the Sensor wear period (day 1 or 2), 50 subjects were analyzed Percent...
Page 72 Table 1b: Accuracy to YSI within CGM Glucose Ranges (Adult; n=144) Table 1c: Accuracy to YSI within CGM Glucose Ranges (Pediatric*; n=129) Number Number Percent Percent Percent Percent Percent Percent Mean Percent Percent Percent Percent Percent Percent Mean Glucose of CGM- MARD Glucose of CGM-...
Page 73 Table 1d: Accuracy to YSI within YSI Glucose Ranges (Adult; n=144) Table 1e: Accuracy to YSI within YSI Glucose Ranges (Pediatric*; n=129) Number Number Percent Percent Percent Percent Percent Percent Mean Percent Percent Percent Percent Percent Percent Mean Glucose of CGM- MARD Glucose of CGM-...
Page 74 Agreement with ‘LO’ and ‘HI’ CGM Reading against YSI Reference Tables 2c and 2d display the concurrence between the CGM and YSI reference glucose when CGM reads ‘HI’ . In the Adult study, when CGM reading was ‘HI’ , YSI glucose values were above 350 mg/dL The System reports glucose concentrations between 40 and 400 mg/dL.
Page 75 Concurrence of System and Reference (CGM vs. YSI) Table 3a: Concurrence Analysis by CGM Glucose Level (Adult; n=144) The percentage of concurring glucose values (CGM vs. YSI) in each glucose reference range is YSI Glucose Level (mg/dL) CGM Glucose presented for each CGM range in Tables 3a and 3b and for each YSI range in Tables 3c and 3d. Level 121- 161-...
Page 76 Table 3b: Concurrence Analysis by CGM Glucose Level (Pediatric*; n=129) Table 3c: Concurrence Analysis by YSI Glucose Level (Adult; n=144) YSI Glucose Level (mg/dL) CGM Glucose Level (mg/dL) CGM Glucose YSI Glucose Level Level 121- 161- 201- 251- 301- 351- 121- 161- 201-...
Page 77 Table 3d: Concurrence Analysis by YSI Glucose Level (Pediatric*; n=129) Glucose Rate of Change Accuracy The System’s glucose rate of change accuracy, as assessed by concurrence analysis, is presented in CGM Glucose Level (mg/dL) YSI Glucose Tables 4a and 4b. For example, in the Adult study, when the Sensor glucose trend arrow indicated Level 121- 161-...
Page 78 False Alarm Rate Table 4b: Concurrence Analysis by Glucose Rate of Change (Pediatric*; n=129) Tells you: Did you get a low glucose alarm that you shouldn’t have? YSI (mg/dL/min) Definition: Percentage of time the alarm issued and blood glucose was not below the alarm level (mg/dL/min) <-2 [-2, -1)
Page 79 Table 5a: Low Glucose Alarm Performance (Adult; n=144) High Glucose Alarm Performance Tables 5c and 5d display the percentages for these parameters: Alarm Rate Detection Rate Low Glucose True Alarm Rate Alarm level Correct Missed Number of True Alarm False Alarm Number of Tells you: When you got a high glucose alarm, were you actually high? (mg/dL)
Page 80 For example, the Adult study found that for a High Glucose alarm level set to 200 mg/dL: Table 5d: High Glucose Alarm Performance (Pediatric*; n=129) 99.2% of the time a high glucose alarm was received when blood glucose was indeed above the Alarm Rate Detection Rate alarm level but 0.8% of the time a high glucose alarm was received when blood glucose wasn’t...
Page 81 Table 6a: Sensor Accuracy Relative to YSI over the wear duration (Adult; n=144) Sensor Wear Duration The Sensor can be worn for up to 14 days. To estimate how long a Sensor will work over the wear Number of duration, 146 Sensors were evaluated in the Adult study and 139 Sensors were evaluated in the Wear Within ±15% / Within ±20% /...
Page 82 Table 7a: Sensor Survival Rate Over Wear Duration (Adult; n=146) Table 7b: Sensor Survival Rate Over Wear Duration (Pediatric; n=139) Day of Wear Number of Sensors Survival Rate (%) Day of Wear Number of Sensors Survival Rate (%) 99.3 98.6 97.8 97.3 95.9...
Page 83 Glucose Reading Availability Table 8b: Glucose Reading Capture Rate Over Wear Duration (Pediatric; n=139) The System is designed to show a Sensor glucose reading after each scan that is performed Day of Wear Number of Sensors Capture Rate (%) throughout the wear period after the start-up time. Tables 8a and 8b show the glucose reading 94.6 capture rate for each day of the wear duration.
Page 84 Precision Adverse Events Precision of the System was evaluated by comparing the results from two separate Sensors worn on No device related serious adverse events occurred during the studies. In the Adult study, mild skin the same subject at the same time. Table 9a provides data from 146 subjects in the Adult study; irritations, such as erythema, bruising, bleeding, and scabbing were reported around the insertion Table 9b provides data from 137 subjects in the Pediatric study.
Page 85: Electromagnetic Compatibility (Emc)
1000 mg ascorbic acid with a meal and the same process was continued for another 4 hours. A • The use of accessories, transducers and cables other than those specified by Abbott Diabetes Care third dose of 1000 mg ascorbic acid was then given and study subjects were followed for 4 more may result in increased EMISSIONS or decreased IMMUNITY of the System.
Page 86 Guidance and manufacturer’s declaration – Guidance and manufacturer’s declaration – electromagnetic immunity electromagnetic emissions 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 87 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 30 A/m 30 A/m Power frequency magnetic fields differential differential...
Page 88 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 Radiated RF 10 V/m 10 V/m Recommended separation communications equipment should distance...
Page 89 Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) Recommended separation distances between portable 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 to System fixed RF transmitters, an electromagnetic site survey should be considered.
Page 90 Font License DEFINITIONS ©2013 Abbott “Font Software” refers to the set of files released by the Copyright Holder(s) under this license and clearly marked Licensed under the Apache License, Version 2.0 (the “License”); you may not use this file except in compliance as such.
Page 91: Limited Warranty
We hope that you are happy with your FreeStyle Libre 2 system. Please refer to the text or binary files as long as those fields can be easily viewed by the user.
Page 92 References: BE UNINTERRUPTED OR ERROR FREE AND ABBOTT WILL NOT BE LIABLE FOR ANY LOST PROFITS, LOST SAVINGS OR OTHER SPECIAL, PUNITIVE, INCIDENTAL “FDA Public Health Notification: Use of Fingerstick Devices on More than One OR CONSEQUENTIAL DAMAGES RESULTING DIRECTLY OR INDIRECTLY FROM Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication”...
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