Abbott FreeStyle Libre 2 User Manual

Flash glucose monitoring system

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

ART41290-501_rev-A_cover.indd 1-2

FLASH GLUCOSE MONITORING SYSTEM

.257"

.224"

4.6"

User's Manual

2/7/24 4:50 PM

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Page 1 User’s Manual Distributed by: Abbott Diabetes Care, Canada 1-888-205-8296 FLASH GLUCOSE MONITORING SYSTEM 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 ©2020-2024 Abbott ART41290-501 Rev. A 02/24 .257”...
Page 2 4.6” 4.6” Your Name _________________________________________________ .257” ART41290-501_rev-A_cover.indd 3-4 ART41290-501_rev-A_cover.indd 3-4 2/7/24 4:50 PM 2/7/24 4:50 PM .224”...
Page 3: Table Of Contents
Contents Reader Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Important Safety Information .
Page 4 Adding Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 Troubleshooting .
Page 5: Reader Symbols
Reader Symbols Symbol What It Means Symbol What It Means Active Sensor Sensor communicating with Reader Direction that your glucose is going . See Checking Sensor not communicating with Reader Your Glucose section for more information . Blood glucose or ketone test Caution View previous/next screen Settings...
Page 6: Important Safety Information
The FreeStyle Libre 2 Flash Glucose Monitoring System (FreeStyle Libre 2 (Computed Tomography) scan . Apply a new Sensor after the appointment . Reader or FreeStyle Libre 2 app or FreeStyle Libre 2 special edition app used with FreeStyle Libre 2 Sensor) is indicated for measuring interstitial fluid glucose levels in people aged 4 years and older with diabetes mellitus .
Page 7 Cautions and Important System Information: What to know about wearing the Sensor: • Some individuals may be sensitive to the adhesive that keeps the Sensor What to know about Glucose Alarms: attached to the skin . If you notice significant skin irritation around or •...
Page 8 • When using the System to replace blood glucose testing for making When is Sensor Glucose different from Blood Glucose: diabetes treatment decisions, including insulin dosing, you should • Glucose levels in the interstitial fluid can be different from blood glucose have a good understanding of how to self-manage your diabetes, levels and may mean that Sensor glucose readings are different from as determined by your health care professional .
Page 9: Interfering Substances
Reader’s USB and test strip ports . What to know about charging your Reader: • Always use the Abbott-provided power adaptor and yellow USB cable that came with your Reader to minimise the risk of fire or burns . Take care when plugging and unplugging your USB cable .
Page 10: Getting To Know Your System
User’s Manual Quick Reference Guide your glucose readings . The Reader only works with FreeStyle Libre 2 Sensors and cannot be used with other Sensors . When they’re in range, the Sensor and Reader automatically communicate to give you glucose alarms .
Page 11: Sensor Kit
The Reader gets glucose readings from your Sensor and can issue glucose Sensor Kit alarms . It can store approximately 90-days of glucose history and notes The Sensor Kit includes: that you enter about activities, such as taking insulin, eating food or exercising .
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: Data Management Software
Data Management Software Setting up Your Reader for the First Time To upload data from the Reader, please visit www .FreeStyleLibre .com and Before using the System for the first time, the Reader must be set up . learn more about the data management software that you can use . Step Action Press the Home Button to turn on the Reader .
Page 14 Step Action Step Action Set the Current Date using the arrows on the The Reader now displays important information about key Current Date topics to help you use the System: touchscreen . Touch next to continue . • How to understand the Glucose Trend Arrow included on June 2020 the Glucose Reading screen .
Page 15: Using Your Sensor
Applying Your Sensor Using Your Sensor Step Action Apply Sensors only on the back of your upper CAUTION: arm . Avoid areas with scars, moles, stretch marks • The Sensor Pack and Sensor Applicator are packaged as a or lumps . set (separately from the Reader) and have the same Sensor Select an area of skin that generally stays flat code .
Page 16 Action Step Step Action Open the Sensor Pack by peeling the lid off The Sensor Applicator is prepared and ready to completely . Unscrew the cap from the Sensor apply the Sensor . Applicator and set the cap aside . CAUTION: The Sensor Applicator now CAUTION: Do NOT use if the Sensor Pack or contains a needle .
Page 17: Starting Your Sensor
Starting Your Sensor Action Step Gently pull the Sensor Applicator away from your Step Action 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 Hold the Reader within 4 cm (1 .5 inches) of the Sensor to scan it . This starts your Sensor . If sounds Turn the Reader on by pressing are turned on, the Reader beeps when the Sensor 10:23pm the Home Button or touch Ends in 14 days...
Page 19 Sensor Glucose Readings Step Action The Reader displays your current glucose reading Glucose Going along with your glucose graph and an arrow Glucose Going Glucose Trend Arrow indicating the direction that your glucose mmol is going . mmol 10pm Current Glucose Target Glucose Range Your Target Glucose Range 10pm...
Page 20 The Glucose Trend Arrow gives you an indication of the direction that your The following table shows messages that you may see with your glucose glucose is going . readings . Display What To Do Glucose is rising quickly (more than 0 . 1 mmol/L per minute) If LO appears on the Reader, your reading is lower Low Glucose than 2 .2 mmol/L .
Page 21: Making Treatment Decisions
Making Treatment Decisions Display What To Do If your glucose is projected to be higher than Work with your health care professional to put together a plan for Glucose Going 13 .3 mmol/L or lower than 3 .9 mmol/L within managing your diabetes that includes when to use the System 15 minutes, you will see a message on the screen .
Page 22: Making Treatment Decisions - Getting Started
Making Treatment Decisions - Getting Started • Sensor accuracy may vary in different situations (meals, exercise, first day of use, etc .) . Sensors may tend to give lower and more variable Before you start using the System for treatment decisions, make sure glucose readings on day 1 of Sensor wear since it takes some time for you have a good understanding of how the System works for your body .
Page 23 When not to use Sensor Glucose readings for treatment decisions If you’re the caregiver, pay attention to times when the symptoms of the one you’re caring for don’t match their Sensor glucose readings . When No Current Glucose number symptoms don’t match readings, do a blood glucose test and treat based When there is no Current Glucose number, such as when you receive an on that result .
Page 24: Understanding The Difference Between Isf Glucose
Understanding the Difference between ISF Glucose and Using Your Glucose Reading to Make a Treatment Blood Glucose Decision Please contact your health care professional if you need help After you scan your Sensor, use all of the information on the understanding the information on this page .
Page 25 Example Scenarios What you see What it means Next are some example scenarios to help you understand how to use Before lunch: When you checked your glucose before lunch, the information on your screen . Always use all of the information on the it was 5 .
Page 26 What you see What it means What you see What it means In the afternoon: Between meals, your current glucose is Before dinner: Before dinner, your current glucose is 4 .0 mmol/L . The Glucose Going Low message 7 .4 mmol/L and within target range . The graph Glucose Going 7:34pm tells you that your glucose is projected to be...
Page 27: Alarms
Alarms IMPORTANT: What you need to know about glucose alarms • The Sensor itself will not issue alarms . When in range of the Reader, your Sensor automatically communicates • Scan your Sensor often to check your glucose . If you get a with the Reader to give you Low and High Glucose Alarms .
Page 28: Setting Alarms
Setting Alarms IMPORTANT: How to prevent missed alarms • Work with your health care professional to determine your alarm settings . Alarms must be kept on for you to receive them and you should ensure that your Reader is within 6 metres (20 ft) of you at all Step Action times .
Page 29 Step Action Alarm How to Set Select the alarm that you want to set or turn off . Change Alarm The High Glucose Alarm is on by default . High Settings Low Glucose Alarm: Notifies you when your Low Glucose Alarm Glucose The alarm level is initially set to glucose is below the level you set .
Page 30: Setting Alarm Sounds
Setting Alarm Sounds Action Step Step Action When you are finished setting your alarms, Change Alarm touch OK . The Alarms Settings screen now Settings From the Home Screen, touch the Low Glucose Alarm shows your current alarm settings . Touch OK 10:23pm Ends in 14 days Settings symbol...
Page 31: 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 The Low Glucose Alarm notifies you if your Low Glucose Alarm 20 minutes and you are not receiving Low or glucose drops below the level that you set .
Page 32: Adding Notes
Adding Notes Step Action After you tick the box for food and Notes can be saved with your glucose readings . You can add a note at the Add Notes insulin notes, the symbol appears time of your glucose reading or within 15 minutes after your reading was Rapid-Acting to the right of the note .
Page 33: 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 34: 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 . Logbook Daily Graph (mmol/L) The graph shows your Target Glucose Range and symbols for food or rapid-acting insulin notes you Entries for each time that you have scanned your have entered .
Page 35: 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 Below...
Page 36: 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 irritation or discomfort at the application site or if the Reader reports a Pull up the edge of the adhesive that keeps your problem with the Sensor currently in use .
Page 37: Using Reminders
Using Reminders Step Action 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 . Note: You can set the reminders for a specific time (e . g . 8:30 am) Step Action or as a timer (e .
Page 38: Using The Built-In Meter
Do not use a wet, bent, scratched or damaged test strip . • The FreeStyle Libre 2 Reader’s built-in meter is for use outside the body Do not use the test strip if the foil packet has a hole or is torn .
Page 39: Blood Glucose Testing
Blood Glucose Testing Step Action You can use the built-in meter to check your blood glucose, whether you Check the test strip expiry date . are wearing a Sensor or not . You can perform a blood glucose test on 13758 2021/ 03 your fingertip or approved alternative site .
Page 40 Step Action Display What To Do You will see a butterfly on the screen while you If LO appears on the Reader, your result is lower Low Glucose wait for your result . If sounds are turned on, the than 1 . 1 mmol/L . If HI appears on the Reader, your result is higher than 27 .8 mmol/L .
Page 41: Blood Ketone Testing
After you get your blood glucose result, you can add Notes by touching Step Action symbol . If you do not want to add a Note, press the Home Button to Check the test strip expiry date . go to the Home Screen or hold the Home Button to turn the Reader off . 13758 2021/ 03 Blood Ketone Testing...
Page 42 Your Blood Ketone Results Step Action 10:23pm Blood ketone results are marked on the results Use your lancing device to obtain a blood drop screen and in the Logbook with the word Ketone . Apply Blood and apply blood to the white area at the end of mmol the test strip .
Page 43: Control Solution Testing
Control Solution Testing Display What To Do You should do a control solution test when you are not sure of your If your blood ketone is high, you will see test strip results and want to check that your Reader and test strips are High Ketone a message on the screen .
Page 44 Step Action Step Action From the Home Screen, touch the Settings Insert the test strip with the three black lines 10:23pm Ends in 14 days symbol . Scroll down using the arrow and facing up . Push the strip until it stops . touch Control Solution Test .
Page 45: Using The Rapid-Acting Insulin Calculator
Using the Rapid-Acting Insulin Calculator 10:23pm Control Solution Results Compare the control solution result to the This optional feature requires an understanding of the use of insulin . range printed on the test strip instructions mmol Misuse or misunderstanding of this feature and the suggested dose for use .
Page 46 Step Action CAUTION: The rapid-acting insulin calculator cannot account Enter information about any rapid- Have you forgotten for all the factors that may affect your insulin dose . These to log any rapid-acting acting insulin that you may have insulin you have taken include incorrectly entered data, incorrectly set date or time, since X:XX? forgotten to log .
Page 47 Step Action Step Action If your calculator was programmed with Easy Review your suggested dose . If needed, use the Suggested Dose Breakfast Setup, touch the meal that you plan to eat now . arrow buttons to adjust your suggested dose for Lunch Adjust if needed Touch next .
Page 48 Step Action If your health care professional turned on the Active 10:23pm Ends in 14 days Insulin feature, the symbol may appear on your Touch log dose to save to your Logbook and take your dose . Home Screen . It shows an estimate of the amount of Your dose is only saved to the Logbook if you touch log dose .
Page 49: Charging The Reader
CAUTION: of debris . • Always use the Abbott provided power adaptor and yellow USB Plug the yellow USB cable into an electrical cable that came with your Reader to minimise the risk of fire or outlet using the power adaptor . Then, plug the burns .
Page 50: Changing The Reader Settings
Changing the Reader Settings Step Action Touch the setting that you want to change: You can go to the Settings menu to change many settings on the Reader, like alarm settings, sound & vibration, time & date and report settings . Alarms –...
Page 51: Living With Your System
Action Living With Your System Step • View Event Logs: A list of events recorded by the Activities Reader, which may be used by Customer Service to help (cont.) Your System can be used during a wide variety of activities . troubleshoot your System •...
Page 52: Cleaning And Disinfection
Activity What You Need To Know Activity What You Need To Know You may use your System while on an aircraft, Travelling by Air Travelling by Air symbol may appear on your glucose following any requests from the flight crew . (cont.) graph indicating the Reader time was changed .
Page 53: Maintenance
Step Action Step Action When finished, thoroughly wash your hands with soap and Disinfection Select new bleach wipe (disinfectant towels containing 0 .55% water . If you require assistance, contact Customer Service . Sodium Hypochlorite (NaOCl) have been found to be effective) CAUTION: Do NOT place the Reader in water or other liquids .
Page 54: 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 The Sensor is The site is not free 1 .
Page 55: Problems Starting Your Sensor Or Receiving Sensor
Problems Starting Your Sensor or Receiving Sensor Display What It May Mean What To Do Readings New Sensor You scanned a new Your Reader can only be used Found Sensor before your with one Sensor at a time . Display What It May Mean What To Do previous Sensor...
Page 56: Problems Receiving Glucose Alarms
Problems Receiving Glucose Alarms Display What It May Mean What To Do Glucose Your Sensor is too Move to a location where the Problem What It May Mean What To Do Reading hot or too cold . temperature is appropriate and You are not You have turned Touch the Settings symbol...
Page 57: Blood Glucose Or Ketone Error Messages
Blood Glucose or Ketone Error Messages Problem What It May Mean What To Do Error You are not You may have set an Confirm your alarm settings are What It May Mean What To Do Message receiving alarm level that is appropriate .
Page 58 Error Error What It May Mean What To Do What It May Mean What To Do Message Message Blood drop is too 1 . Review the testing Blood was applied 1 . Review the testing small . instructions . to the test strip too instructions .
Page 59: Problems Checking Your Blood Glucose Or Ketone
Problems Checking Your Blood Glucose or Ketone Error What It May Mean What To Do Message Problem What It May Mean What To Do Test strip may be 1 . Check that you are using The Reader Test strip is not 1 .
Page 60: Perform A Reader Test
Perform a Reader Test Problem What It May Mean What To Do If you think the Reader is not working properly, you can The test Blood sample is too 1 . See test strip instructions System Status check the Reader by performing a Reader Test . Touch does not small .
Page 61: Professional Options
Changing Dose Increments Professional Options You can set the insulin dose increments to either 1 .0 or 0 .5 units for use This section is only meant for health care professionals . It describes the with the Rapid-acting insulin calculator and insulin notes . access code-protected features of the Reader .
Page 62: Setting Up The Insulin Calculator
Setting up the Insulin Calculator You can set up the insulin calculator using the Easy or Advanced settings . The Easy Setup is for patients who start with a fixed dose of The insulin calculator can help your patients calculate their rapid-acting rapid-acting insulin for meals .
Page 63: Easy Setup Of The Insulin Calculator
Easy Setup of the Insulin Calculator Step Action Step Action Enter the Correction Factor (for example: if 1 unit Correction Factor of insulin lowers blood glucose 2 . 8 mmol/L, then Choose the Easy option on the slide bar and 1 u insulin for the correction factor is 2 .
Page 64: Units Of Insulin 0 .5 Or
Calculator Settings - Easy Option Notes about the Easy Option: • The calculator estimates the amount of rapid-acting insulin still in the This page can be used to record insulin calculator settings . body and how much longer it may be active (if the correction factor is set to ‘No correction insulin’...
Page 65: Advanced Setup Of The Insulin Calculator
Advanced Setup of the Insulin Calculator Action Step Step Action If you chose to enter Grams of carbs in Step 2: Carbohydrate Ratio The rapid-acting insulin dose suggestion is based Choose the Advanced option on the slide bar 1 u insulin for Choose Setup Option on grams of carbs .
Page 66 Action Action Step Step Select how you want your patient to correct their If you chose to enter Carb Portions in Step 2: Carb Portions How does your Definition patient correct their The rapid-acting insulin dose suggestion is glucose . Touch next glucose? 1 portion = based on carbohydrate portions .
Page 67 Action Step Action Step Enter the Insulin Duration . This is the amount of Enter the Correction Factor (for example: if Correction Factor Insulin Duration time that rapid-acting insulin remains active in 1 unit of insulin lowers blood glucose 2 .8 mmol/L, 1 u insulin for 4:30 the patient’s body .
Page 68 Notes about the Advanced Option: Step Action • The calculator estimates the amount of rapid-acting insulin still in Select whether or not to show the Active Insulin the body and how much longer it may be active . The active insulin Do you want the Active Insulin symbol symbol...
Page 69 Calculator Settings - Advanced Option This graph shows how the insulin calculator estimates the amount of active insulin as a function of logged insulin dose and insulin duration This page can be used to record insulin calculator settings . over time . It also shows the relationship between the symbol and amount of active insulin .
Page 70: Changing The Insulin Calculator Settings
Changing the Insulin Calculator Settings This is the estimated amount blood Correction Factor Action Step glucose will drop by taking one unit 1 unit of insulin for of insulin . (Option to enter by time From the Home Screen, touch the Settings of day .) symbol .
Page 71: System Specifications
System Specifications Sensor transmission 6 metres (20 ft) unobstructed range See test strip and control solution instructions for use for additional specifications . 10°C to 45°C Operating temperature Sensor Specifications Sensor glucose assay Sensor Applicator and Amperometric electrochemical sensor method 4°C to 25°C Sensor Pack storage temperature...
Page 72: Reader Specifications
90 days of typical use Reader memory 3 years of typical use Mean service life Reader operating 10°C to 45°C Abbott Diabetes Care PRT31887 temperature Power Adaptor Output: 5 V, 550 mA or 0 .55A Reader storage Operating temperature: 10°C to 40°C -20°C to 60°C...
Page 73: Rapid-Acting Insulin Calculator Specifications
Labelling Symbols Rapid-Acting Insulin Calculator Specifications Consult instructions for Parameter Unit Range or Value Use-by date mmol/L 3 .9 to 10 .0 Correction target Temperature limit Catalogue number 1 unit per X grams 1 to 50 Carbohydrate ratio of carbs Manufacturer Serial number Units of insulin per...
Page 74: Performance Characteristics
(day 9 or 12), and 51 subjects were analysed during the end period (day 13 or 14). effectiveness and precision of the FreeStyle Libre 2 Flash Glucose Monitoring System (System). All subjects tested their blood glucose using fingerstick capillary samples at least four times during One study included adults (Adult study) and the other study included children (Paediatric study).
Page 75 Table 1a: Overall Accuracy to YSI Table 1b: Accuracy to YSI within GM Glucose Ranges (Adult; n=144) Number of Percent Number Percent Percent Percent Percent Within Percent Percent Percent Mean Subject Number of Within ±20% / Glucose of GM- Within Within Within MARD...
Page 76 Table 1c: Accuracy to YSI within GM Glucose Ranges (Paediatric*; n=129) Table 1d: Accuracy to YSI within YSI Glucose Ranges (Adult; n=144) Number Percent Percent Percent Number Percent Percent Percent Percent Percent Percent Mean Percent Percent Percent Mean Glucose of GM- Within Within Within...
Page 77 Table 1e: Accuracy to YSI within YSI Glucose Ranges (Paediatric*; n=129) Agreement with ‘LO’ and ‘HI’ GM Reading against YSI Reference The System reports glucose concentrations between 2.2 and 22.2 mmol/L. When the System Number Percent Percent Percent Percent Percent Percent Mean determines that glucose level is below 2.2 mmol/L, it will report as ‘LO’...
Page 78 Tables 2c and 2d display the concurrence between the GM and YSI reference glucose when GM Concurrence of System and Reference (GM vs. YSI) reads ‘HI’ . In the Adult study, when GM reading was ‘HI’ , YSI glucose values were above 22.2 mmol/L The percentage of concurring glucose values (GM vs.
Page 79 Table 3a: Concurrence Analysis by GM Glucose Level (Adult; n=144) Table 3b: Concurrence Analysis by GM Glucose Level (Paediatric*; n=129) GM Glucose GM Glucose YSI Glucose Level (mmol/L) YSI Glucose Level (mmol/L) Level Level 2.2- 3.4- 4.5- 6.7- 8.9- 11.2- 13.9- 16.7- 19.5-...
Page 80 Table 3d: Concurrence Analysis by YSI Glucose Level (Paediatric*; n=129) Table 3c: Concurrence Analysis by YSI Glucose Level (Adult; n=144) YSI Glucose YSI Glucose GM Glucose Level (mmol/L) GM Glucose Level (mmol/L) Level Level 2.2- 3.4- 4.5- 6.7- 8.9- 11.2- 13.9- 16.7- 19.5-...
Page 81 Glucose Rate of Change Accuracy Table 4b: Concurrence Analysis by Glucose Rate of Change (Paediatric*; n=129) The System’s glucose rate of change (ROC) accuracy, as assessed by concurrence analysis, is presented YSI Rate (mmol/L/min) GM Rate in Tables 4a and 4b. For example, in the Adult study, when the Sensor glucose rate of change (mmol/L/min) <-0.1 [-0.1, -0.06) [-0.06, 0.06] (0.06, 0.1]...
Page 82 False Alarm Rate Table 5a: Low Glucose Alarm Performance (Adult; n=144) Tells you: Did you get a low glucose alarm that you shouldn’t have? Alarm Rate Detection Rate Definition: Percentage of time the alarm issued and blood glucose was not below the alarm level Low Glucose within 15 minutes before or after the alarm.
Page 83 For example, the Adult study found that for a High Glucose alarm level set to 11.1 mmol/L: High Glucose Alarm Performance 99.2% of the time a high glucose alarm was received when blood glucose was indeed above the Tables 5c and 5d display the percentages for these parameters: alarm level but 0.8% of the time a high glucose alarm was received when blood glucose wasn’t True Alarm Rate actually above the alarm level.
Page 84 Table 5d: High Glucose Alarm Performance (Paediatric*; n=129) Sensor Accuracy Over Time The Sensor can be worn for up to 14 days. The percentage of System readings within YSI values and Alarm Rate Detection Rate High Glucose the Mean Absolute Relative Difference (MARD) is presented for the following different wear periods Alarm level in Tables 6a and 6b: Beginning (Adult: 144 Subjects, Day 1, 2 or 3;...
Page 85 Table 6b: Sensor Accuracy Relative to YSI over the wear duration (Paediatric*; n=129) 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 Within ±15% / Within ±20% / Within ±40% / duration, 146 Sensors were evaluated in the Adult study and 139 Sensors were evaluated in the...
Page 86 Table 7a: Sensor Survival Rate Over Wear Duration (Adult; n=146) Table 7b: Sensor Survival Rate Over Wear Duration (Paediatric; n=139) Day of Wear Number of Sensors Survival Rate (%) Day of Wear Number of Sensors Survival Rate (%) 99.3 98.6 97.3 97.8 95.9...
Page 87 Glucose Reading Availability Table 8b: Glucose Reading Capture Rate over Wear Duration (Paediatric; 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 94.4 capture rate for each day of the wear duration.
Page 88 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) and mild pain were reported around Table 9b provides data from 137 subjects in the Paediatric study.
Page 89: Electromagnetic Compatibility
1000 mg every four hours could significantly raise Sensor glucose interference received, including interference that may cause undesired operation. readings. • Changes or modifications not approved by Abbott could void the user’s authority to operate the equipment. ART41290-501_rev-A_manual.indd 169-170 ART41290-501_rev-A_manual.indd 169-170...
Page 90: Guidance And Manufacturer's Declaration - Electromagnetic Emissions
Note: This equipment has been tested and found to comply with the limits for a Class B digital Guidance and manufacturer’s declaration – device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable electromagnetic emissions protection against harmful interference in a residential installation.
Page 91: Guidance And Manufacturer's Declaration - Electromagnetic Immunity
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 ensure that it is used in such an environment.
Page 92 10 V/m 10 V/m of the System, including cables IEC 61000-4-3 80 MHz to specified by Abbott Diabetes Care. 2.7 GHz Otherwise, degradation of the performance of the System could NOTE U is the a.c. mains voltage prior to application of the test level.
Page 93 The table below lists the immunity test levels at specific test frequencies for testing the effects IMMUNITY Test of some wireless communications equipment. The frequencies and services listed in the table are Band Maximum Distance TEST frequency Service Modulation representative examples in healthcare and in various locations where the System may be used. (MHz) power (W) LEVEL...
Page 94 ©2013 Abbott Interference may occur in the vicinity of equipment marked with the following symbol: Licensed under the Apache Licence, Version 2.0 (the ‘Licence’); you may not use this file except in compliance with the Licence.
Page 95 DEFINITIONS 5) The Font Software, modified or unmodified, in part or in whole, must be distributed entirely under this licence, ‘Font Software’ refers to the set of files released by the Copyright Holder(s) under this licence and clearly marked and must not be distributed under any other licence. The requirement for fonts to remain under this licence does not apply to any document created using the Font Software.
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