The gray top of the Abbott Libre 2 is secured with multiple internal and external locks and is not designed to be removed easily. It was specifically made to resist disassembly. To remove it, you must release the internal locks by prying carefully. However, there are also external locks that are difficult to access without tools. The plastic is soft and can be cut easily if needed.

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Summary of Contents for Abbott FreeStyle Libre 2

Page 1 User’s Manual FLASH GLUCOSE MONITORING SYSTEM...
Page 2 Your Name _________________________________________________...
Page 3: Table Of Contents
Contents Reader Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Important Safety Information .
Page 4 Reviewing Your History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Logbook .
Page 5 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83 Reader Does Not Power On .
Page 6: Reader Symbols
Reader Symbols Symbol What It Means Active Sensor Direction your glucose is going . See Checking Your Glucose section for more information . Caution View previous/next screen Notes Add more information to notes Food note Rapid-acting insulin note Time changed on Reader Sound and Vibration ON Sound ON, Vibration OFF Sound OFF, Vibration ON...
Page 7 Symbol What It Means Sensor communicating with Reader Sensor not communicating with Reader Blood glucose or ketone test Settings Control solution test result Rapid-acting insulin calculator Details of your suggested insulin dose Estimated rapid-acting insulin remaining in body Low battery Battery charging Sensor too cold Sensor too hot...
Page 8: Important Safety Information
Indications for Use The FreeStyle Libre 2 Flash Glucose Monitoring System Reader (“Reader”), when used with a FreeStyle Libre 2 Flash Glucose Monitoring System Sensor (“Sensor”), is indicated for measuring interstitial fluid glucose levels in people (aged 4 and older) with diabetes mellitus, including pregnant women .
Page 9: Contraindications
. If you are experiencing symptoms that are not consistent with your glucose readings, consult your health care professional . • The FreeStyle Libre 2 Flash Glucose Monitoring System (“System”) contains small parts that may be dangerous if swallowed .
Page 10 Cautions and Important System Information: What the System has not been evaluated for: • The System has not been evaluated for use with other implanted medical devices such as pacemakers . • The System has not been evaluated for use in persons on dialysis, or people less than 4 years of age .
Page 11 When to remove the Sensor: • On rare occasions, you may get inaccurate Sensor glucose readings . If you believe your glucose readings are not correct or do not match how you feel, perform a blood glucose test on your finger to confirm your glucose .
Page 12 What to know about wearing the Sensor: • Do not reuse Sensors . The Sensor and Sensor Applicator are designed for single use . Reuse may result in no glucose readings and infection . Not suitable for re-sterilisation . Further exposure to irradiation may cause inaccurate results .
Page 13 What to know about the Reader’s Built-in Meter: • The Reader is designed to be used only with FreeStyle Optium blood glucose and blood ketone test strips and MediSense control solution . • The Reader is for use by a single person . It must not be used on more than one person including other family members due to the risk of spreading infection .
Page 14: Interfering Substances
Interfering Substances You can take standard doses of ascorbic acid (vitamin C) and still make treatment decisions with the Sensor . Taking higher than the maximum recommended daily allowance (RDA) of ascorbic acid may affect the Sensor readings and make them look higher than they really are .
Page 15: Getting To Know Your System
. You use the Reader to wirelessly scan the Sensor and display your glucose readings . The Reader only works with FreeStyle Libre 2 Sensors and cannot be used with other Sensors . The FreeStyle Libre 2 Sensor automatically communicates with the Reader and can give you glucose alarms if you choose to turn those on .
Page 16: Reader Kit
Reader Kit The Reader Kit includes: • • • FreeStyle Libre 2 Reader Power Adaptor Quick Start Guide • • • USB Cable User’s Manual Performance Data Insert Touchscreen USB Port Used to charge the Reader and connect it to a computer.
Page 17: 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 your body . prepare the Sensor for use . The Sensor measures and stores glucose readings when worn on your body .
Page 18 The Reader Home Screen provides access to information about your glucose and the System . You can press the Home Button to get to the Home Screen . Home Screen Battery charge remaining Sound/Vibration setting Current time set on the Reader Signal Status Shows if Sensor is communicating with Reader.
Page 19 The Sensor Glucose Readings screen appears after you use the Reader to scan your Sensor . Your Reading includes your Current Glucose, a Glucose Trend Arrow indicating which way your glucose is going, and a graph of your current and stored glucose readings . Sensor Glucose Readings Message Add Notes...
Page 20: Freestyle Libre Software
Sensor glucose readings, blood glucose test results, blood ketone test results and other data uploaded from the FreeStyle Libre 2 Flash Glucose Monitoring System, in support of an effective diabetes health management programme .
Page 21: Setting Up Your Reader For The First Time
Setting up Your 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 22 Step Action Set the Current Date using the arrows on the Current Date touchscreen . Touch next to continue . June 2018 back next Set the Current Time . Touch next to continue . Current Time CAUTION: It is very important to set the time and date correctly .
Page 23 Step Action The Reader now displays important information about two key topics to help you use the System: • How to understand the Glucose Trend Arrow included on the Glucose Reading screen . • How to return to the Home Screen from any other screen . When you scan your Sensor an arrow will indicate your recent glucose trend:...
Page 24: Using Your Sensor
Using Your Sensor CAUTION: • The Sensor Pack and Sensor Applicator are packaged as a set (separately from the Reader) and have the same Sensor code . Check that the Sensor codes match FreeStyle Libre before using your Sensor Pack and Sensor Sensor Pack Applicator .
Page 25: Applying Your Sensor
Applying Your Sensor Action Step Apply Sensors only on the back of your upper arm . Avoid areas with scars, moles, stretch marks or lumps . Select an area of skin that generally stays flat during your normal daily activities (no bending or folding) .
Page 26 Action Step Open the Sensor Pack by peeling the lid off completely . Unscrew the 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 27 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 your body .
Page 28 Action Step Gently pull the Sensor Applicator away from your body . The Sensor should now be attached to your 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 29: Starting Your Sensor
Starting Your Sensor Action Step Press the Home Button to turn on the Reader . Touch Start New Sensor . 22:23 No Active Sensor Start New Review Sensor History Hold the Reader within 4 cm (1 .5 inches) of the Sensor to scan it .
Page 30: Checking Your Glucose
Checking Your Glucose Step Action Turn the Reader on by pressing 22:23 the Home Button or touch Ends in 14 days Check Glucose from the Home Check Review Screen . Glucose History Hold the Reader within 4 cm (1 .5 inches) of your Sensor to scan it .
Page 31 Step Action The Reader displays your current glucose reading along with your glucose graph and an arrow Glucose Going indicating the direction your glucose is going . mmol 14:00 18:00 22:00...
Page 32 Sensor Glucose Readings Glucose Going Glucose Trend Arrow mmol Current Glucose Target Glucose Range Your Target Glucose Range 14:00 18:00 22:00 is not related to your glucose alarm settings . Notes: • The graph displays glucose readings up to 21 mmol/L . Glucose readings above 21 mmol/L are displayed at 21 mmol/L .
Page 33 The Glucose Trend Arrow gives you an indication of the direction your glucose is going . Glucose is rising quickly (more than 0 . 1 mmol/L per minute) Glucose is rising (between 0 .06 and 0 . 1 mmol/L per minute) Glucose is changing slowly (less than 0 .06 mmol/L per minute) Glucose is falling...
Page 34 The following table shows messages you may see with your glucose readings . Display What To Do If LO appears on the Reader, your reading is lower Low Glucose than 2 .2 mmol/L . If HI appears on the Reader, your reading is higher than 27 .8 mmol/L .
Page 35 Display What To Do If your glucose is projected to be higher than Glucose Going 13 .3 mmol/L or lower than 3 .9 mmol/L within 15 minutes, you will see a message on the screen . mmol You can touch the message button for more Glucose Going information and set a reminder to check your High...
Page 36: Alarms
Alarms When in range of the Reader, your Sensor automatically communicates with the Reader to give you Low and High Glucose Alarms if you turn them ON . These alarms are turned OFF by default . This section explains how to turn on and set alarms as well as how to use them .
Page 37 IMPORTANT: What you need to know about glucose alarms • Scan your Sensor often to check your glucose . If you get a Low or High Glucose Alarm, you must obtain a glucose result to determine what to do next . •...
Page 38 IMPORTANT: How to prevent missed alarms • For you to receive alarms, they must be turned ON and you should ensure that your Reader is within 6 metres (20 ft) of you at all times . The Sensor itself will not issue alarms . •...
Page 39: Setting Alarms
Setting Alarms Work with your health care professional to determine your alarm settings . Step Action From the Home screen, touch the Settings 22:23 Ends in 14 days . Touch Alarms . symbol Check Review Settings Glucose History Alarms Sound & Vibration Time &...
Page 40 Step Action Select the alarm you want to turn on and set . Change Alarm Settings Low Glucose Alarm: Notifies you when your Low Glucose Alarm glucose is below the level you set . High Glucose Alarm High Glucose Alarm: Notifies you when your Signal Loss Alarm glucose is above the level you set .
Page 41 Alarm How to Set High The High Glucose Alarm is off by default . Glucose Touch the slider to turn the alarm High Glucose Alarm Alarm on . The alarm level is initially set to 13 .3 mmol/L . You can use the mmol/L arrows to change this value between 6 .
Page 42 Action Step When you are finished setting your alarms, Change Alarm touch OK . The Alarms Settings screen now Settings Low Glucose Alarm shows your current alarm settings . Touch OK to return to the main settings menu, or touch High Glucose Alarm Change Alarm Settings to make additional Signal Loss Alarm...
Page 43: Setting Alarm Sounds
Setting Alarm Sounds Step Action From the Home screen, touch the 22:23 Ends in 14 days . Touch Sound & Settings symbol Vibration to change the alarm sounds . Check Review Settings Glucose History Alarms Sound & Vibration Time & Date 1 / 4 Touch the sound or vibration setting you Sound &...
Page 44: Using Alarms
Using Alarms What you See What it Means The Low Glucose Alarm notifies you if your Low Glucose Alarm glucose drops below the level you set . The alarm does not include your glucose reading, so you need to scan your Sensor to check your glucose . Dismiss Alarm &...
Page 45 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 minutes and you are not receiving Low or Scan Sensor now? High Glucose Alarms . Signal loss could be caused by the Sensor being too far away from the Reader (over 6 metres (20 ft)) or another issue such as an error or problem with your Sensor or Reader .
Page 46: Adding Notes
Adding Notes Notes can be saved with your glucose readings . You can add a note at the time of your glucose reading or within 15 minutes after your reading was obtained . You can track food, insulin, exercise and any medication you take .
Page 47 Step Action After you tick the box for food and Add Notes insulin notes, the symbol appears Rapid-Acting to the right of the note . You can touch Insulin Long-Acting it to add more specific information to Insulin Enter Rapid-Acting Insulin your note .
Page 48: Reviewing Your History
Reviewing Your History Reviewing and understanding your glucose history can be an important tool for improving your glucose control . The Reader stores about 90 days of information and has several ways to review your past glucose readings, notes, and other information . Step Action Press the Home Button to turn on...
Page 49 Step Action Use the arrows to view the available options . Review History Logbook Daily Graph Daily Patterns Average Glucose Time In Target 1 / 2 Low Glucose Events Sensor Usage IMPORTANT: Work with your health care professional to understand your glucose history .
Page 50: Logbook
The Logbook and Daily Graph show detailed information, while other history options show summaries of information over a number of days . Logbook Entries for each time you scanned your Sensor Logbook or performed a blood glucose or ketone test . 23 Feb 10:23 If you entered Notes with a glucose reading,...
Page 51: Daily Graph
Daily Graph A graph of your Sensor glucose readings by day . Daily Graph (mmol/L) The graph shows your Target Glucose Range and symbols for food or rapid-acting insulin notes you have entered . 00:00 12:00 24:00 Notes: 22 Feb •...
Page 52: Other History Options
Other History Options Use the arrows to view information about your last 7, 14, 30 or 90 days . Information about the average of your Sensor Average Glucose glucose readings . The overall average for the time Average: mmol/L is displayed above the graph . The average is also shown for four different 6-hour periods of the day .
Page 53 A graph showing the percentage of time your Time In Target Sensor glucose readings were above, below, or Above within your Target Glucose Range . In Target Below Target Range 4.4-10.0 mmol/L Last 7 Days Time In Target Information about the number of low glucose Low Glucose Events events measured by your Sensor .
Page 54: Removing Your Sensor
Removing Your Sensor Step Action Pull up the edge of the adhesive that keeps your Sensor attached to your skin . Slowly peel away from your skin in one motion . Note: Any remaining adhesive residue on the skin can be removed with warm, soapy water or isopropyl alcohol .
Page 55: Replacing Your Sensor
Replacing Your Sensor Your Sensor automatically stops working after 14 days of wear and 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 problem with the Sensor currently in use .
Page 56: Using Reminders
Using Reminders You can use Reminders to help you remember things like checking your glucose or taking insulin . Step Action From the Home Screen, touch the Settings 22:23 Ends in 14 days symbol Scroll down using the arrow and Check Review touch Reminders .
Page 57 Step Action Touch to select how often you want the reminder to Repeat: Once, Daily or Timer . Note: You can set the reminders for a specific time (e . g . 8:30 am) or as a timer (e . g . 3 hours from the current time) . Set the reminder Time using the arrows on the touchscreen .
Page 58: Using The Built-In Meter
Using the Built-in Meter The Reader has a built-in meter that can be used to test your blood glucose and blood ketone, or to test the meter and strips with control solution . WARNING: Do NOT use the built-in meter while the Reader is connected to an electrical outlet or a computer .
Page 59 IMPORTANT: • Use the Reader within the test strip operating temperature range as blood glucose and ketone results obtained outside the range may be less accurate . • Use only FreeStyle Optium test strips . • Use a test strip immediately after removing it from its foil packet .
Page 60: Blood Glucose Testing
Blood Glucose Testing You can use the built-in meter to check your blood glucose, whether you are wearing a Sensor or not . You can perform a blood glucose test on your fingertip or approved alternative site . Ensure that you read the test strip instructions for use prior to using the built-in meter .
Page 61 Step Action Check the test strip expiry date . 13758 2016/ 03 E .g . Expiry date: 31 March 2021 Open the foil test strip packet at the notch and tear down to remove the test strip . Use the test strip immediately after removing it from the foil packet .
Page 62 Step Action You will see a butterfly on the screen while you wait for your result . If sounds are turned on, the Reader beeps once when your result is ready . After reviewing your result, remove and discard the used test strip according to test strip instructions for use .
Page 63 Display What To Do If LO appears on the Reader, your result is lower Low Glucose than 1 . 1 mmol/L . If HI appears on the Reader, your result is higher than 27 .8 mmol/L . You can touch mmol the message button for more information .
Page 64: Blood Ketone Testing
After you get your blood glucose result, you can add Notes by touching symbol . If you do not want to add a Note, press the Home Button to go to the Home Screen or hold the Home Button to turn the Reader off . Blood Ketone Testing You can use the built-in meter to check your blood ketone (β-hydroxybutyrate) .
Page 65 Step Action Check the test strip expiry date . 13758 2016/ 03 E .g . Expiry date: 31 March 2021 Open the foil test strip packet at the notch and tear down to remove the test strip . Use the test strip immediately after removing it from the foil packet .
Page 66 Step Action Use your lancing device to obtain a blood drop Apply Blood and apply blood to the white area at the end of the test strip . If sounds are turned on, the Reader beeps once Ketone Test to let you know you have applied enough blood . Note: See test strip instructions for use for re-application instructions .
Page 67 Your Blood Ketone Results 22:23 Blood ketone results are marked on the results screen and in the Logbook with the word Ketone . mmol Ketone Test Notes: • Blood ketone is expected to be lower than 0 .6 mmol/L . •...
Page 68 Display What To Do If your blood ketone is high, you will see a High Ketone message on the screen . You can touch the message button for more information . mmol Ketone Test If HI appears on the Reader, your ketone result is High Ketone higher than 8 mmol/L .
Page 69: Control Solution Testing
Control Solution Testing You should do a control solution test when you are not sure of your test strip results and want to check that your Reader and test strips are working properly . You can do a control solution test with a blood glucose or ketone test strip .
Page 70 Action Step From the Home Screen, touch the Settings 22:23 Ends in 14 days symbol . Scroll down using the arrow and touch Control Solution Test . Check Review Glucose History Reminders Control Solution Test Language 2 / 4 Check the test strip expiry date . 13758 2016/ 03 E .g .
Page 71 Action Step Insert the test strip with the three black lines facing up . Push the strip until it stops . Shake the control solution bottle to mix the Apply Control Solution solution . Apply a drop of control solution to the white area at the end of the test strip .
Page 72 Control Solution Results 22:23 Compare the control solution result to the range printed on the test strip instructions for use . The result on your screen should be mmol in this range . Control solution results are marked on Control Solution Test the results screen and in the Logbook with a symbol .
Page 73: Using The Rapid-Acting Insulin Calculator
Using the Rapid-Acting Insulin Calculator This optional feature requires an understanding of the use of insulin . Misuse or misunderstanding of this feature and the suggested dose may lead to inappropriate insulin dosing . The calculator suggests doses for rapid-acting insulin only . The calculator is only for use with fingerstick blood glucose results from the built-in meter .
Page 74 CAUTION: The rapid-acting insulin calculator cannot account for all the factors that may affect your insulin dose . These include incorrectly entered data, incorrectly set date or time, un-logged insulin, smaller or larger meals, sickness, exercise, etc . It is important that you review your suggested dose and account for these factors before taking insulin .
Page 75 Step Action Enter information about any Have you forgotten to log any rapid-acting rapid-acting insulin you may have insulin you have taken since X:XX? forgotten to log . Touch next . Enter any rapid- acting insulin you have forgotten to log. units How long ago was back...
Page 76 Step Action If your calculator was programmed with Easy Breakfast Setup, touch the meal you plan to eat now . Lunch Touch next . Dinner No meal back next If your calculator was programmed with Enter Carbs Advanced Setup, enter the grams of carbohydrates or carbohydrate portions you grams plan to eat now .
Page 77 Step Action Review your suggested dose . If needed, use the Suggested Dose arrow buttons to adjust your suggested dose for Adjust if needed any planned activity, a smaller or larger meal, sickness, etc . Touch the symbol to see details of what is included in your suggested dose .
Page 78 Step Action Touch log dose to save to your Logbook and take your dose . Your dose is only saved to the Logbook if you touch log dose . CAUTION: It is important to log all your rapid-acting insulin doses so your Reader can account for active insulin when calculating your suggested doses .
Page 79 If your health care professional turned on the Active 22:23 Ends in 14 days Insulin feature, the symbol may appear on your Home Screen . It shows an estimate of the amount of rapid-acting insulin left in your body and how much Check Review longer it may be active .
Page 80: Charging The Reader
Charging 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 accompanies your result when you have enough charge remaining for about one day Low Battery of use .
Page 81: Changing The Reader Settings
Changing the Reader Settings You can go to the Settings menu to change many settings on the Reader, like alarm settings, sound & vibration, time & date, and report settings . The Settings menu is also where you go to do a control solution test or to check the System status .
Page 82 Action Step Touch the setting you want to change: Alarms – See Alarms section for information on setting alarms Sound & Vibration – Set Reader sound and vibration . These also apply to alarms Time & Date – Change the Time or Date Reminders –...
Page 83 Action Step • View Event Logs: A list of events recorded by the Reader, which may be used by Customer Service to help (cont.) troubleshoot your System • Perform a Reader Test: The Reader Test will perform internal diagnostics and allow you to check that the display is showing all pixels, sounds and vibrations are working and the Touchscreen is responding when touched...
Page 84: Living With Your System
Living With Your System Activities Your System can be used during a wide variety of activities . Activity What You Need To Know Bathing, The Reader is not water-resistant and should Showering and NEVER be submerged in water or other liquid . Swimming Your Sensor is water-resistant and can be worn while bathing, showering or swimming .
Page 85 Activity What You Need To Know Travelling by Air You may use your System while on an aircraft, following any requests from the flight crew . • Some airport full-body scanners include x-ray or millimetre radio-wave, which you cannot expose your Sensor to .
Page 86: Cleaning
Activity What You Need To Know Travelling by Air symbol may appear on your glucose (cont.) graph, indicating that the Reader time was changed . Gaps in the graph may result or glucose readings may be hidden . Cleaning You may clean the Reader as often as desired using a cloth dampened with a mixture of 1 part household bleach to 9 parts water .
Page 87: Disposal
Disposal Reader, Sensor, USB Cable and Power Adaptor: These devices must not be disposed of via municipal waste collection . Separate collection for electrical and electronic equipment waste as per Directive 2012/19/EC in the European Union is required . Contact the manufacturer for details .
Page 88: Troubleshooting
Troubleshooting This section lists problems or observations that you may have, 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 89: Problems At The Sensor Application Site
Problems at the Sensor Application Site Problem What It May Mean What To Do The Sensor is The site is not free 1 . Remove the Sensor . not sticking of dirt, oil, hair or 2 . Clean the site with plain to your skin .
Page 90: Problems Starting Your Sensor Or Receiving
Problems Starting Your Sensor or Receiving Sensor Readings Display What It May Mean What To Do New Sensor Sensor is not ready Wait until the 60-minute Sensor Starting Up to read glucose . start-up period has completed . Scan The Reader is not Hold the Reader within Timeout held close enough...
Page 91 Display What It May Mean What To Do New Sensor You scanned a new Your Reader can only be used Found Sensor before your with one Sensor at a time . If you previous Sensor start a new Sensor, you will no ended .
Page 92 Display What It May Mean What To Do Glucose Your Sensor is too Move to a location where the Reading hot or too cold . temperature is appropriate and Unavailable scan again in a few minutes . Sensor The Sensor was Your Reader can only be used Already in started by another...
Page 93: Problems Receiving Glucose Alarms
Problems Receiving Glucose Alarms Problem What It May Mean What To Do You are not You have not turned Touch the Settings symbol receiving alarms on . and then select Alarms . glucose alarms . The Sensor is not The Sensor must be within range communicating with (6 metres (20 ft)) of the Reader for your Reader .
Page 94 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 . glucose higher or lower than alarms . you intended . (cont.) You have already You will receive another alarm dismissed this type when a new low or high glucose...
Page 95: Blood Glucose Or Ketone Error Messages
Blood Glucose or Ketone Error Messages Error What It May Mean What To Do Message The temperature is 1 . Move the Reader and test too hot or too cold strips to a location where the for the Reader to temperature is within the test work correctly .
Page 96 Error What It May Mean What To Do Message Blood drop is too 1 . Review the testing small . instructions . 2 . Repeat the test using a new test strip . Incorrect test 3 . If the error reappears, contact procedure Customer Service .
Page 97 Error What It May Mean What To Do Message Blood was applied 1 . Review the testing to the test strip instructions . too soon . 2 . Repeat the test using a new test strip . 3 . If the error reappears, contact Customer Service .
Page 98 Error What It May Mean What To Do Message Test strip may be 1 . Check that you are using damaged, used or the correct test strip for the Reader does not the Reader . (See test strip recognise it . instructions for use to verify your strip is compatible with the Reader .
Page 99: Problems Checking Your Blood Glucose Or Ketone
Problems Checking Your Blood Glucose or Ketone Problem What It May Mean What To Do The Reader Test strip is not 1 . With the three black lines does not inserted correctly facing up, insert the test start a or not inserted fully strip into the strip port until test after into the strip port .
Page 100 Problem What It May Mean What To Do The test Blood sample is 1 . See test strip instructions does not too small . for use for re-application start after instructions . applying 2 . Repeat the test using a new the blood test strip .
Page 101: Perform A Reader Test
Perform a Reader Test If you think the Reader is not working properly, you can System Status check the Reader by performing a Reader Test . Touch System Info the Settings symbol from the Home Screen, select Reader Test System Status and then select Reader Test . Event Log Note: The Reader Test will perform internal diagnostics and will allow you to check that the display, sounds and...
Page 102: Professional Options
Professional Options This section is only meant for health care professionals . It describes the access code-protected features of the Reader . Health care professionals can change dose increments or set up the insulin calculator . From the Home Screen, touch the Settings symbol .
Page 103: Changing Dose Increments
Changing Dose Increments You can set the insulin dose increments to either 1 .0 or 0 .5 units for use with the rapid-acting insulin calculator and insulin notes . From the Professional Options screen, select Dose Increment Dose Increment . Then choose 1 unit or 0.5 unit . 1 unit Touch done .
Page 104: Setting Up The Insulin Calculator
Setting up the Insulin Calculator The insulin calculator can help your patients calculate their rapid-acting insulin doses based on meal and fingerstick blood glucose level information . From the Professional Options screen, select Insulin Calculator . CAUTION: This feature requires an understanding of the use of insulin .
Page 105 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 rapid-acting insulin for meals . The Advanced Setup is for patients who count carbohydrates (in grams or carbohydrate portions) to adjust their rapid-acting insulin dose for meals .
Page 106: Easy Setup Of The Insulin Calculator
Easy Setup of the Insulin Calculator Action Step Choose the Easy option on the slide bar and Choose Setup Option touch next . Easy Note: You need to know your patient’s For patients who start with a fixed dose of rapid-acting meal-time insulin doses, target glucose range insulin at meals.
Page 107 Action Step Enter the Correction Factor (for example: if 1 unit Correction Factor of insulin lowers blood glucose 2 .8 mmol/L, then 1 u insulin for the correction factor is 2 .8) . If the blood glucose mmol value is outside the blood glucose target, the calculator will use the correction target and factor to calculate a correction dose .
Page 108 Notes about the Easy Option: • The calculator estimates the amount of rapid-acting insulin still in the body and how much longer it may be active (if the correction factor is set to “no correction insulin”, active insulin is not calculated) . The active insulin estimate is based on a 4-hour insulin duration calculated from the time and amount of the last logged rapid-acting insulin dose .
Page 109 Calculator Settings – Easy Option This page can be used to record insulin calculator settings . This is the insulin Breakfast Lunch Dinner required to cover food . Dose Dose Dose units of insulin units of insulin units of insulin 0-50 0-50 0-50...
Page 110: Advanced Setup Of The Insulin Calculator
Advanced Setup of the Insulin Calculator Action Step Choose the Advanced option on the slide bar Choose Setup Option and touch next . Advanced Note: You need to know your patient’s meal- For patients who count carbs (in grams or portions) to adjust time insulin settings, target glucose range, their rapid-acting insulin dose at meals.
Page 111 Action Step If you chose to enter Grams of carbs in Step 2: Carbohydrate Ratio The rapid-acting insulin dose suggestion is based 1 u insulin for on grams of carbs . Enter the Carbohydrate Ratio (1 unit of rapid- grams carbs by time acting insulin for ______ grams of carbs) .
Page 112 Action Step If you chose to enter Carb Portions in Step 2: Carb Portions Definition The rapid-acting insulin dose suggestion is based 1 portion = on carbohydrate portions . grams carbs Enter the Carb Portions Definition (10 to 15 grams of carbs) and touch next . Enter the Carb Portion Ratio back next...
Page 113 Action Step Select how you want your patient to correct their How does your patient correct their glucose . Touch next glucose? To a single target To a target range back next Enter the Correction Target value or range . This Correction Target is the desired target value or range for blood glucose values before meals .
Page 114 Action Step Enter the Correction Factor (for example: if Correction Factor 1 unit of insulin lowers blood glucose 2 .8 mmol/L, 1 u insulin for then the correction factor is 2 .8) . If the blood mmol glucose reading is outside the blood glucose by time Optional: of day...
Page 115 Action Step Enter the Insulin Duration . This is the amount of Insulin Duration time that rapid-acting insulin remains active in 4:30 the patient’s body . hrs:min Touch next . back next IMPORTANT: In general, the insulin duration for rapid- acting insulin ranges from 3-5 hours, and can vary for each person .
Page 116 Action Step Select whether or not to show the Active Insulin Do you want the Active Insulin symbol symbol on the Home Screen . to be displayed on the Home Screen? This symbol shows an estimate of the amount of rapid-acting insulin still in the body and how much longer it may be active .
Page 117 Notes about the Advanced Option: • The calculator estimates the amount of rapid-acting insulin still in the body and how much longer it may be active . The active insulin estimate is calculated from the set insulin duration, the time and amount of the last logged rapid-acting insulin dose .
Page 118 This graph shows how the insulin calculator estimates the amount of active insulin as a function of logged insulin dose and insulin duration over time . It also shows the relationship between the symbol and amount of active insulin . Active insulin curvilinear model % insulin duration Adapted from Mudaliar et al .
Page 119 Calculator Settings – Advanced Option This page can be used to record insulin calculator settings . This is the number of grams of carbs Carbohydrate that one unit of rapid-acting insulin Ratio 1 unit of insulin for will cover OR the number of units of rapid-acting insulin that will cover one carb portion .
Page 120 This is the estimated amount blood Correction Factor glucose will drop by taking one unit 1 unit of insulin for of insulin . (Option to enter by time of day .) mmol/L 0.1-5.5 Insulin Duration This is the amount of time that a dose Insulin is active in the body for of rapid-acting insulin remains active in the body .
Page 121: Changing The Insulin Calculator Settings
Changing the Insulin Calculator Settings Action Step From the Home Screen, touch the Settings symbol . Scroll down using the arrows and Reader Basics touch Professional Options . Enter the access Professional Options code . Touch Insulin Calculator . 4 / 4 Touch Turn Off Calculator to turn off the insulin Calculator Settings calculator or Change Calculator Settings to...
Page 122: System Specifications
System Specifications See test strip and control solution instructions for use for additional specifications . Sensor Specifications Sensor glucose Amperometric electrochemical sensor assay method Sensor glucose 2 .2 to 27 .8 mmol/L reading range Sensor size 5 mm height and 35 mm diameter Sensor weight 5 grams Sensor power source...
Page 123 Sensor transmission 6 metres (20 ft) unobstructed range Operating temperature 10°C to 45°C Sensor Applicator and Sensor Pack storage 4°C to 25°C temperature Operating and storage 10-90%, non-condensing relative humidity IP27: Can withstand immersion into Sensor water resistance one metre (three ft) of water for up to and ingress protection 30 minutes .
Page 124 Reader Specifications Blood glucose 1 .1 to 27 .8 mmol/L assay range Blood ketone assay range 0 .0 to 8 .0 mmol/L 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 4 days of typical use Reader memory...
Page 125 System must only be used with Requirements EN60950-1 rated computers Mean service life 3 years of typical use Abbott Diabetes Care PRT25612 Power Adaptor Operating temperature: 10°C to 40°C Abbott Diabetes Care PRT21373 USB Cable Length: 94 cm (37 inches)
Page 126: Rapid-Acting Insulin Calculator Specifications
Rapid-Acting Insulin Calculator Specifications Parameter Unit Range or Value Correction target mmol/L 3 .9 to 10 .0 1 unit per X grams Carbohydrate ratio 1 to 50 of carbs Units of insulin per Carb portion ratio 0 .5 to 15 carb portion Carb portion definition Grams of carbs...
Page 127: Labelling Symbols
Labelling Symbols Consult instructions for use Use-by date Temperature limit Catalogue number Manufacturer Date of Manufacture CE Mark Serial number Authorised Representative in Single sterile barrier the European Community system Batch code Keep dry Type BF applied part Non-ionising radiation CODE Sensor code Caution...
Page 128: 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 129 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. Electromagnetic Emissions test Compliance environment –...
Page 130 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 131 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 domestic, commercial or IEC 61000-4-5 mode mode hospital environment. ± 2 kV common ±...
Page 132 IMMUNITY IEC 60601 Compliance Electromagnetic test test level level environment – guidance Power frequency 30 A/m 30 A/m Power frequency magnetic fields (50/60 Hz) should be at levels characteristic magnetic field of a typical location in a typical domestic, commercial or hospital IEC 61000-4-8 environment.
Page 133 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 134 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 metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey , should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol:...
Page 135 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 136 Abbott Diabetes Care Ltd. hereby declares that the radio equipment type FreeStyle Libre 2 Reader is in compliance with Directive 2014/53/EU. The full text of the EU declaration of conformity is available at...
Page 137 Font Licence ©2013 Abbott Licensed under the Apache Licence, Version 2.0 (the “Licence”); you may not use this file except in compliance with the Licence. You may obtain a copy of the Licence at: http://www.apache.org/licenses/LICENSE-2.0 Unless required by applicable law or agreed to in writing, software distributed under the Licence is distributed on an “AS IS”...
Page 138 DEFINITIONS “Font Software” refers to the set of files released by the Copyright Holder(s) under this licence and clearly marked as such. This may include source files, build scripts and documentation. “Reserved Font Name” refers to any names specified as such after the copyright statement(s). “Original Version”...
Page 139 5) The Font Software, modified or unmodified, in part or in whole, must be distributed entirely under this licence, 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. TERMINATION This licence becomes null and void if any of the above conditions are not met.
Page 140 Abbott GmbH Max-Planck-Ring 2 65205 Wiesbaden Germany FreeStyle, Libre, and related brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions. Other trademarks are the property of their respective owners. Patent: https://www.abbott.com/patents Abbott Diabetes Care Ltd. Range Road...

Abbott FreeStyle Libre 2 User Manual

Reader Symbols

Important Safety Information

Getting to Know Your System

Setting up Your Reader for the First Time

Using Your Sensor

Alarms

Adding Notes

Reviewing Your History

Removing Your Sensor

Replacing Your Sensor

Using Reminders

Using the Built-In Meter

Charging the Reader

Changing the Reader Settings

Living with Your System

Troubleshooting

Professional Options

System Specifications

Rapid-Acting Insulin Calculator Specifications

Labelling Symbols

Electromagnetic Compatibility

Quick Links

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