Abbott Diabetes Care LIB01 Freestyle Libre Glucose Monitoring System User Manual

Abbott Diabetes Care Freestyle Libre Glucose Monitoring System

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LIB01 User Manual

User Manual

DO NOT PRINT FROM THIS FILE - FOR REFERENCE ONLY

Reader Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Important Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Getting to Know Your System . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Reader Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Sensor Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 FreeStyle Libre Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Setting up Your Reader for the First Time . . . . . . . . . . . . . . 14 Using Your Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Applying Your Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Starting Your Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Checking Your Glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Adding Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Contents

Reviewing Your History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Logbook . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Daily Graph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Other History Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Removing Your Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Replacing Your Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Using Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Using the Built-in Meter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Blood Glucose Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Blood Ketone Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 Control Solution Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 Using the Rapid-Acting Insulin Calculator . . . . . . . . . . . . . . . . 56 Charging the Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 Changing the Reader Settings . . . . . . . . . . . . . . . . . . . . . . . . . 64 Living With Your FreeStyle Libre System . . . . . . . . . . . . . . . 67 Maintenance and Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70 Reader Does Not Power On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70 Problems at the Sensor Application Site . . . . . . . . . . . . . . . . . . 71 Problems Starting Your Sensor or Receiving Sensor Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72 Blood Glucose or Ketone Error Messages . . . . . . . . . . . . . . . . . 75 Problems Checking Your Blood Glucose or Ketone . . . . . . . . 79 Perform a Reader Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81 Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81 Professional Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82 Changing Dose Increments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83 Setting up the Insulin Calculator . . . . . . . . . . . . . . . . . . . . . . . . . 84 Easy Setup of the Insulin Calculator . . . . . . . . . . . . . . . . . . . . . . 86 Advanced Setup of the Insulin Calculator . . . . . . . . . . . . . . . . . 90 Changing the Insulin Calculator Settings . . . . . . . . . . . . . . . . 101 System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102 Rapid-Acting Insulin Calculator Specifications . . . . . . . . 106 Labeling Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108 Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . 109 DOC28687_rev-E_manual.indd 2-3 3/30/14 2:52 PM

Symbol What It Means 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 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 Reminders 1 2 DOC28687_rev-E_manual.indd 1-2 3/30/14 2:52 PM

Important Safety Information Indications for Use The FreeStyle Libre Flash Glucose Monitoring System is indicated for measuring interstitial fluid glucose levels in adults aged 18 years and older . It is designed to replace blood glucose testing in the self-management of diabetes with the exceptions listed below . Under the following circumstances, use a blood glucose meter to check the current glucose readings from the FreeStyle Libre Flash Glucose Monitoring System Sensor: • During times of rapidly changing glucose levels, interstitial glucose levels as measured by the Sensor and reported as current may not accurately reflect blood glucose levels . When glucose levels are falling rapidly, glucose readings from the Sensor may be higher than blood glucose levels . Conversely when glucose levels are rising rapidly, glucose readings from the Sensor may be lower than blood glucose levels . • In order to confirm hypoglycemia or impending hypoglycemia as reported by the Sensor . • If symptoms do not match the FreeStyle Libre Flash Glucose Monitoring System reading . Do not ignore symptoms that may be due to low blood glucose or high blood glucose . Contraindications The FreeStyle Libre Flash Glucose Monitoring System must be removed prior to Magnetic Resonance Imaging (MRI) . WARNING: • The FreeStyle Libre Flash Glucose Monitoring System contains small parts that may be dangerous if swallowed . • During times of rapidly changing glucose (more than 2 mg/dL per minute), interstitial fluid glucose levels as measured by the FreeStyle Libre Flash Glucose Monitoring System Sensor may not accurately reflect blood glucose levels . Under these circumstances, check the Sensor glucose readings by conducting a fingerstick test using a blood glucose meter . • In order to confirm hypoglycemia or impending hypoglycemia as reported by the FreeStyle Libre Flash Glucose Monitoring System Sensor, conduct a fingerstick test using a blood glucose meter . • Do not ignore symptoms that may be due to low or high blood glucose . If you have symptoms that do not match the FreeStyle Libre Flash Glucose Monitoring System reading or suspect that your reading may be inaccurate, check the reading by conducting a fingerstick test using a blood glucose meter . If you are experiencing symptoms that are not consistent with your glucose readings, consult your health care professional . 3 4 DOC28687_rev-E_manual.indd 3-4 3/30/14 2:52 PM

CAUTION: • On rare occasions, you may get inaccurate Sensor glucose readings . If you believe your glucose readings are not correct or are inconsistent with how you feel, perform a blood glucose test on your finger to confirm your glucose . If the problem continues, remove the current Sensor and apply a new one . • Performance of the System when used with other implanted medical devices, such as pacemakers, has not been evaluated . • 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 . All parts of the Reader are considered biohazardous and can potentially transmit infectious diseases, even after performing the cleaning procedure . System-Related Information • The FreeStyle Libre Flash Glucose Monitoring System is designed to be used only with FreeStyle Precision/FreeStyle Optium blood glucose and blood ketone test strips and MediSense control solution . • Avoid getting dust, dirt, blood, control solution, water, or other substances in the Reader’s USB and test strip ports . • Physiologic differences between the interstitial fluid and capillary blood may result in differences in glucose readings . Differences in glucose readings between interstitial fluid and capillary blood may be observed during times of rapid change in blood glucose, such as after eating, dosing insulin, or exercising . • Severe dehydration and excessive water loss may cause inaccurate results . If you believe you are suffering from dehydration, consult your health care professional immediately . Confirm Precision or Optium test strip as appropriate for market . Change MediSense to Optium for Australia . 5 6 DOC28687_rev-E_manual.indd 5-6 3/30/14 2:52 PM

• If you have a medical appointment that includes strong magnetic or electromagnetic radiation, for example an X-ray, MRI (Magnetic Resonance Imaging), or CT (Computed Tomography) scan, remove the Sensor you are wearing and apply a new one after the appointment . The effect of these types of procedures on the performance of the system has not been evaluated . • The FreeStyle Libre Flash Glucose Monitoring System has not been evaluated for use in pregnant women, persons on dialysis, or people less than 18 years of age . Getting to Know Your System The FreeStyle Libre Flash Glucose Monitoring System has two main parts: a handheld Reader and a disposable Sensor, which you wear on your body . You use the Reader to wirelessly scan the Sensor and get your glucose readings . The Reader also has a built-in blood glucose and ketone meter, which works with FreeStyle Precision/FreeStyle Optium blood glucose and blood ketone test strips . IMPORTANT: Safety information about the System is in this User’s Manual . Read all of the information in the User’s Manual and the FreeStyle Precision/FreeStyle Optium blood glucose and ketone test strip instructions for use before using your System . Your System comes in a Reader Kit and a Sensor Kit . When opening your kits, check that the contents are undamaged and that you have all parts listed . If any parts are missing or damaged, contact Customer Service . 7 8 DOC28687_rev-E_manual.indd 7-8 3/30/14 2:52 PM

Reader Kit The Reader Kit includes: • 1 FreeStyle Libre Reader • 1 USB Cable USB Port Used to charge the Reader and connect it to a computer. Test Strip Port • 1 Power Adapter • User’s Manual • Quick Start Guide Touchscreen Home Button Turns the Reader on/off and takes you to the Home screen from any Sensor Kit The Sensor Kit includes: • 1 Sensor Pack • 1 Sensor Applicator Sensor Pack Used with the Sensor Applicator to prepare the Sensor for use . • 1 Alcohol wipe • Product insert Sensor Applicator Applies the Sensor to your body . Insert a test strip here to use the built-in meter. other screen. The Sensor measures and stores glucose readings when worn on your body . It initially comes in two parts: one part is in the Sensor Pack and the other part is in the Sensor Applicator . By following the instructions, you prepare and apply the Sensor on the back of your The Reader is used to get glucose readings from your Sensor . It can store approximately 90-days of glucose history and notes you enter about activities, such as taking insulin, eating food, or exercising . This information can help you understand how these activities affect your glucose . upper arm . The Sensor has a small, flexible tip that is inserted just under the skin . The Sensor can be worn for up to 14 days . Sensor Measures your glucose while on your body (only visible after applied). 9 10 DOC28687_rev-E_manual.indd 9-10 3/30/14 2:52 PM

92 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 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 Time Current time set on the Reader. Sensor Status Information about your current Sensor. Check Glucose Touch to check your Sensor glucose. 10:23pm Ends in 14 days Check Glucose Review History Battery Level Battery charge remaining. Settings Touch to change the Reader’s settings. Review History Touch to review information Message Touch for more information. Current Glucose Glucose from your latest scan. Food Note 350 250 150 50 Glucose Going Low mg dL Add Notes Touch to add notes to the glucose reading. Glucose Trend Arrow Direction your glucose is going. Rapid-Acting Insulin Note Reminder Touch to set or change reminders. about your past glucose readings. 2pm 6pm 10pm Glucose Graph Graph of your current and stored glucose readings. 11 12 DOC28687_rev-E_manual.indd 11-12 3/30/14 2:52 PM

Step Action 1 Press the Home Button to turn on the Reader . 2 If prompted, use the touchscreen to select your preferred language for the Reader . Touch OK to continue . Note: Use the pad of your finger . Do NOT use your fingernail or any other object on the screen . 3 Current Date Set the Current Date using the arrows on the touchscreen . Touch next to continue . 14 June 2014 back next FreeStyle Libre Software FreeStyle Libre software can be used to view reports and change Reader settings . The software is compatible with most Windows and Mac operating systems . Go to www .FreeStyleLibre .com and follow onscreen instructions to download and install the software . Setting up Your Reader for the First Time Before using the System for the first time, the Reader must be set up . INTENDED USE FreeStyle Libre software is intended for use by individuals and health care professionals to aid in the review, analysis, and evaluation of information such as Sensor glucose readings, blood glucose test results, blood ketone test results, and other data uploaded from the FreeStyle Libre Flash Glucose Monitoring System, in support of an effective diabetes health management program . FreeStyle Libre software is not intended for the diagnosis of or screening for diabetes mellitus . Users should be aware that FreeStyle Libre software is merely an information management tool and it is therefore not intended to substitute for the support of a health care professional . Individuals should always consult their health care professional if they have any queries or concerns about diabetes management . 13 14 DOC28687_rev-E_manual.indd 13-14 3/30/14 2:52 PM

Step Action 4 Current Time Set the Current Time . Touch next to continue . 12 am 00 CAUTION: It is very important to set the time and date correctly . These values affect the Reader data and settings . back next 5 Target Glucose ? Set your Target Glucose Range . Work with your Range health care professional to determine your Target Glucose Range . Touch next to continue . 80 to 140 dL mg Note: Your Target Glucose Range is displayed on glucose graphs on the Reader and used to back next calculate your Time In Target . Step Action 6 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: Rising quickly While using the Reader, press Rising the Home button to return to the Home screen. Changing slowly Falling Touch next to move to the Falling quickly next topic . At the end of the back next Reader setup, touch done to go to the Home Screen . back done Note: Charge the Reader if the battery level is low . Only use the USB cable and power adapter included with the System . 15 16 DOC28687_rev-E_manual.indd 15-16 3/30/14 2:52 PM

Step Action 1 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) . Choose a site that is at least 2 .5 cm (1 inch) away from an insulin injection site . To prevent discomfort or skin irritation, you should select a different site other than the one most recently used . 2 Clean application site with an alcohol wipe and allow site to dry before proceeding . This helps the Sensor stay attached to your body . Note: The area MUST be clean and dry, or the Sensor may not stick to the site . Using Your Sensor Applying Your Sensor CAUTIONS: • 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 before using your Sensor Pack and Sensor Applicator . Sensor Packs and Sensor Applicators with the same Sensor code should be used together or your Sensor glucose readings may be incorrect . FreeSty Sensor P CODE XXX XXXXXXXX YYYY/M • Intense exercise may cause your Sensor to loosen due to sweat or movement of the Sensor . If your Sensor comes loose, you may get no readings or unreliable readings, which may not match how you feel . Follow the instructions to select an appropriate application site . 17 18 DOC28687_rev-E_manual.indd 17-18 3/30/14 2:52 PM

Step Action 6 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 . 7 Place the Sensor Applicator over the prepared site and push down firmly to apply the Sensor to your body . CAUTION: Do NOT push down on the Sensor Applicator until placed over prepared site to prevent unintended results or injury . Step Action 3 Lid 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 Cap the Sensor Applicator seem to be damaged or already opened . Do NOT use if past expiration date . 4 Line up the dark mark on the Sensor Applicator with the dark mark on the Sensor Pack . Press firmly down on the Sensor Applicator until it comes to a stop . 5 Lift the Sensor Applicator out of the Sensor Pack . 19 20 DOC28687_rev-E_manual.indd 19-20 3/30/14 2:52 PM

Step Action 8 Gently pull the Sensor Applicator away from your body . The Sensor should now be attached to your Sensor skin . 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 . 9 Make sure the Sensor is secure after application . Put the cap back on the Sensor Applicator . Discard the used Sensor Pack and Sensor Applicator according to local regulations . 6 Starting Your Sensor Step Action 1 Press the Home Button to turn on the Reader . 2 10:23pm No Active Sensor Touch Start New Sensor . Start New Sensor Review History 3 Hold the Reader within 4 cm (1 .5 inches) of the Sensor to scan it . This starts your Sensor . If sounds are turned on, the Reader beeps when the Sensor New Sensor OK Starting Up Sensor can be used in: minutes has been successfully activated . The Sensor can be used to check your glucose after 60 minutes . Note: If the Sensor is not successfully scanned within 15 seconds, the Reader displays a prompt to scan the Sensor again . Touch OK to return to the Home Screen and touch Start New Sensor to scan your Sensor . 21 22 DOC28687_rev-E_manual.indd 21-22 3/30/14 2:52 PM

Step Action 3 The Reader displays your current glucose reading Glucose Going along with your glucose graph and an arrow Low 350 92 indicating the direction your glucose is going . mg dL 250 150 50 2pm 6pm 10pm Checking Your Glucose Step Action 1 10:23pm En ds in 14 days OR Check Glucose Review Histo ry Turn the Reader on by pressing the Home Button or touch Check Glucose from the Home Screen . 2 Hold the Reader within 4 cm (1 .5 inches) of your Sensor to scan it . Your Sensor wirelessly sends glucose readings to the Reader . If sounds are turned on, the Reader beeps when the Sensor has been successfully scanned . Note: If the Sensor is not successfully scanned within 15 seconds, the Reader displays a prompt to scan the Sensor again . Touch OK to return to the Home Screen and touch Check Glucose to scan your Sensor . 23 24 DOC28687_rev-E_manual.indd 23-24 3/30/14 2:52 PM

Glucose is rising quickly (more than 2 mg/dL per minute) Glucose is rising (between 1 and 2 mg/dL per minute) Glucose is changing slowly (less than 1 mg/dL per minute) Glucose is falling (between 1 and 2 mg/dL per minute) Glucose is falling quickly (more than 2 mg/dL per minute) 92 Sensor Glucose Readings The Glucose Trend Arrow gives you an indication of the direction your glucose is going . Glucose Going Low Glucose Trend Arrow Target Glucose Range mg dL 350 250 150 50 Current Glucose 2pm 6pm 10pm Notes: • The graph displays glucose readings up to 350 mg/dL . Glucose readings above 350 mg/dL are displayed at 350 mg/dL . • The symbol may appear, indicating the Reader time was changed . Gaps in the graph may result or glucose readings may be hidden . Note: The Glucose Trend Arrow may not always appear with your reading . 25 26 DOC28687_rev-E_manual.indd 25-26 3/30/14 2:52 PM

Display What To Do Glucose Going Low 72 mg dL 350 250 Glucose Going High 150 50 237 dL 350 250 150 50 2pm 6pm 10pm If your glucose is projected to be higher than 240 mg/dL or lower than 70 mg/dL within 15 minutes, you will see a message on the screen . You can touch the message button for more information and set a reminder to check your glucose . Display What To Do Low Glucose LO mg dL 350 250 150 High Glucose 50 HI mg 2pm 6pm 10pm dL 350 250 150 50 2pm 6pm 10pm If LO appears on the Reader, your reading is lower than 40 mg/dL . If HI appears on the Reader, your reading is higher than 500 mg/dL . You can touch the message button for more information . Check your blood glucose on your finger with a test strip . If you get a second LO or HI result, contact your health care professional immediately . Low Glucose 63 mg dL 350 250 High Glucose 150 50 289 2pm 6pm 10pm mg dL 350 250 150 50 2pm 6pm 10pm If your glucose is higher than 240 mg/dL or lower than 70 mg/dL, you will see a message on the screen . You can touch the message button for more information and set a reminder to check your glucose . The following table shows messages you may see with your glucose readings . 2pm 6pm 10pm mg Note: If you are not sure about a message or reading, contact your health care professional before you do anything . 27 28 DOC28687_rev-E_manual.indd 27-28 3/30/14 2:52 PM

Step Action 1 Glucose Goi ng From the Glucose Reading screen, add notes Low by touching the symbol in the upper right 92 mg corner of the touchscreen . If you do not want to dL 350 250 add notes, you can press the Home Button to go 150 to the Home Screen or hold the Home Button to 50 2pm 6pm 10pm turn the Reader off . 2 Select the checkbox next to the notes you would like to add . Touch the down arrow to view other Insulin Note options . Long-Acting Insulin Food 1 / 4 + + Adding Notes Step Action 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 . 3 Add Notes Rapid-Acting Insulin Long-Acting Insulin Food OK + +Enter Rapid-Acting OK Insulin + 1 / 4 After you check the box for food and insulin notes, the + symbol appears to the right of the Note . You can touch it to add more specific information to your note . Then touch OK . • Insulin notes: Enter the number of units units taken . • Food notes: Enter grams or serving information . Note: Food and rapid-acting insulin notes are shown on your glucose graphs and in your Logbook as symbols . Add Notes OK Rapid-Acting 4 Add Notes OK Rapid-Acting Insulin Long-Acting Insulin Food + Touch OK to save your Notes . 1 / 4 You can review your Notes from the Logbook . See Reviewing Your History section for more information . 29 Remove magenta content for France . 30 DOC28687_rev-E_manual.indd 29-30 3/30/14 2:52 PM

Step Action 3 Review History Use the arrows to view the available options . 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 . 2 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 1 Che ck Glucose Sc an Sensor to check gluco se. Press the Home Button to turn on the Reader . Press the Home Button again to go to the Home Screen . 10:23pm En ds in 14 days Touch the Review History icon . Chec k Glucose Revie w Hist ory 31 32 DOC28687_rev-E_manual.indd 31-32 3/30/14 2:52 PM

143 108 98 The Logbook and Daily Graph show detailed information, while other history options show summaries of information over a number of days . Daily Graph Logbook Logbook OK Entries for each time you scanned your Sensor Daily Graph OK (mg/dL) 350 250 150 A graph of your Sensor glucose readings by day . The graph shows your Target Glucose Range and symbols for food or rapid-acting insulin notes you have entered . or performed a blood glucose or ketone test . 50 12 6 12 6 12 23 Feb 10:23am 23 Feb 6:37am If you entered Notes with a glucose reading, the symbol appears in that row . For more am a m pm pm am 22 Feb Wednesday Notes: • The graph displays glucose readings up to 22 Feb 11:09pm mg/dL information about the symbols, see Reader Symbols section . Touch the entry to review the detailed information, including any Notes you entered . You can add or edit (change) Notes for the most recent Logbook entry, provided your glucose reading was within the last 15 minutes and you have not used FreeStyle Libre software to create reports . 350 mg/dL . Glucose readings above 350 mg/dL are displayed at 350 mg/dL . • You might see gaps in the graph during times when you have not scanned at least once in 8 hours . • The symbol may appear indicating the Reader time was changed . Gaps in the graph may result or glucose readings may be hidden . 33 34 DOC28687_rev-E_manual.indd 33-34 3/30/14 2:52 PM

5 Other History Options Use the arrows to view information about your last 7, 14, 30, or 90 days . Time In Target OK A graph showing the percentage of time your Sensor glucose readings were above, below, or Average Glucose OK Information about the average of your Sensor Above In Target Below 12% 34% 54% within your Target Glucose Range . Average: 119 mg/dL 152 134 glucose readings . The overall average for the time is displayed above the graph . The average is also Target Range 80-140 mg/dL Last 7 Days 121 12 69 6 12 6 12 shown for four different 6-hour periods of the day . Time In Target am a m pm pm am Last 7 Days Average Glucose Readings above or below your Target Glucose Range are orange, while readings in range are blue . Low Glucose OK Events Total Events: 10 6 3 Information about the number of low glucose events measured by your Sensor . A low glucose event is recorded when your Sensor glucose reading is lower than 70 mg/dL for longer 1 0 12 6 12 6 12 than 15 minutes . The total number of events Daily Patterns OK (mg/dL) 350 250 150 50 A graph showing the pattern and variability of your Sensor glucose over a typical day . The thick black line shows the median (midpoint) of your glucose readings . The gray shading represents a range am a m pm pm am Last 7 Days Low Glucose Events is displayed above the graph . The bar graph displays the low glucose events in four different 6-hour periods of the day . 12 6 12 6 12 (10-90 percentiles) of your Sensor readings . Information about how often you scan your Sensor . am a m pm pm am Last 7 Days Daily Patterns Note: Daily Patterns needs at least 5 days of glucose data . Sensor Usage OK Scans Per Day Sensor Data The Reader reports an average of how many times you scanned your Sensor each day, and the Captured 100% Last 7 Days percentage of possible Sensor data the Reader recorded from your scans . Sensor Usage 35 36 DOC28687_rev-E_manual.indd 35-36 3/30/14 2:52 PM

Removing Your Sensor Step Action 1 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 . 2 Discard the used Sensor according to local regulations . See Maintenance and Disposal section . When you are ready to apply a new Sensor, follow the instructions in the Applying Your Sensor and Starting Your Sensor sections . If you removed your last Sensor before 14 days of use, you will be prompted to confirm that you would like to start a new Sensor when you first scan it . 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 . Taking action early can keep small problems from turning into larger ones . CAUTION: If the glucose readings from the FreeStyle Libre Flash Glucose Monitoring System do NOT seem to match with how you feel, check to make sure that your Sensor has not come loose . If the Sensor tip has come out of your skin, or your Sensor is coming loose, remove the Sensor and apply a new one . 37 38 DOC28687_rev-E_manual.indd 37-38 3/30/14 2:52 PM

Step Action 4 Set the reminder Time using the arrows on the touchscreen . Touch save . 5 Reminders From the Reminders screen, you can turn the reminder On/Off or add new reminders . 8:30am On Touch done to return to the Home Screen . 12:30pm Off 00:00:00 On add new done Step Action 1 10:23pm Ends in 14 days From the Home Screen, touch the symbol . Check Review Glucose History 2 Set Reminder Touch to select which Type of reminder you want to set: Check Glucose, Take Insulin, or Alarm . Type Alarm Repeat Daily Time XX:XX cancel save 3 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) . Using Reminders You can use Reminders to help you remember to check your glucose, take insulin, or as a general alarm . Reminder 8:30am Alarm snooze 15 min OK When reminders are On, the next reminder time appears next to the reminder symbol on the Home Screen . For example, 8:30am Your reminder comes on even if the Reader is turned off . Touch OK to dismiss your reminder or snooze to be reminded again in 15 minutes . Note: Reminders will not appear if the Reader is connected to a computer . 39 40 DOC28687_rev-E_manual.indd 39-40 3/30/14 2:52 PM

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 . 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 Precision/FreeStyle Optium test strips . • Use a test strip immediately after removing from its foil packet . • Only use a test strip once . • Do not use expired test strips as they may cause inaccurate results . • Do not use a wet, bent, scratched, or damaged test strip . • Do not use the test strip if the foil packet has a hole or is torn . • Results from the built-in meter are shown only in your Logbook and not in other history options . • Refer to your lancing device instructions for use for how to use your lancing device . 41 42 DOC28687_rev-E_manual.indd 41-42 3/30/14 2:52 PM

Step Action 2 D5 Check the test strip expiration date . 13758 2016/03 E .g . Expiration date: March 31, 2016 3 Open the foil test strip packet at the notch and tear down to remove the test strip . Use the test strip immediately after removing from the foil packet . 4 Insert the test strip with the three black lines at the end facing up . Push the strip in until it stops . 5 Apply Blood Use your lancing device to obtain a blood drop and apply blood to the white area at the end of the test strip . If sounds are turned on, the Reader beeps once to let you know you have applied enough blood . Note: See test strip instructions for use for re-application instructions . Blo S Abbott Di a b et es C ar e Ltd. Range Road Witney, Oxon, OX 29 0YL Made in UK . 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 alternate site . Be sure to read the test strip instructions for use prior to using the built-in meter . Step Action 1 CAUTION: If you think you have low glucose (hypoglycemia) or you suffer from hypoglycemia unawareness, test on your fingers . Wash your hands and the test site with warm soapy water for accurate results . Thoroughly dry your hands and the test site . To warm the site, apply a warm dry pad or rub vigorously for a few seconds . Note: Avoid areas near bones and areas with lots of hair . If you get a bruise, consider selecting another site . 43 44 DOC28687_rev-E_manual.indd 43-44 3/30/14 2:52 PM

Display What To Do Low Glucose LO mg dL High Glucose HI dL If LO appears on the Reader, your result is lower than 20 mg/dL . If HI appears on the Reader, your result is higher than 500 mg/dL . You can touch the message button for more information . Check your blood glucose again with a test strip . If you get a second LO or HI result, contact your health care professional immediately . Low Glucose 63 mg dL High Glucose 289 mg dL If your glucose is higher than 240 mg/dL or lower than 70 mg/dL, you will see a message on the screen . You can touch the message button for more information and set a reminder to check your glucose . dL 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 . 6 After reviewing your result, remove and discard the used test mg strip according to local regulations . 10:23pm IMPORTANT: After performing a blood glucose test, wash your hands and the test site with soap and water and thoroughly dry them . Your Blood Glucose Results Blood glucose results are marked on the results screen and in the Logbook with the 143 mg symbol . Note: Contact your health care professional if you have symptoms that do not match your test results . 45 46 DOC28687_rev-E_manual.indd 45-46 3/30/14 2:52 PM

Step Action 2 D5 Check the test strip expiration date . 13758 2016/03 E .g . Expiration date: March 31, 2016 3 Open the foil test strip packet at the notch and tear down to remove the test strip . Use the test strip immediately after removing from the foil packet . 4 Note: Use only blood ketone test strips . Do not put urine on the test strip . Insert the test strip with the three black lines facing up . Push the strip in until it stops . Blo S Abbott Di a b et es C ar e Ltd. Range Road Witney, Oxon, OX 29 0YL Made in UK . After you get your blood glucose result, you can add Notes by touching the 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) . It is important to consider doing this when: • You are sick • Your glucose is higher than 240 mg/dL • You and your health care professional decide you should Note: Be sure to read the test strip instructions for use prior to performing a ketone test . Step Action 1 Wash your hands with warm soapy water for accurate results . Thoroughly dry your hands . To warm the site, apply a warm dry pad or rub vigorously for a few seconds . Note: Use only fingertip samples for blood ketone testing . 47 48 DOC28687_rev-E_manual.indd 47-48 3/30/14 2:52 PM

Step Action 5 Apply Blood Ketone Test Use your lancing device to obtain a blood drop and apply blood to the white area at the end of the test strip . If sounds are turned on, the Reader beeps once to let you know you have applied enough blood . Note: See test strip instructions for use for re-application instructions . 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 . 6 After reviewing your result, remove and discard the used test strip according to local regulations . IMPORTANT: After performing a blood ketone test, wash your hands with soap and water and thoroughly dry them . 10:23pm 0.4 mmol Your Blood Ketone Results Blood ketone results are marked on the results screen and in the Logbook with the word Ketone . L Ketone Test Notes: • Blood ketone is expected to be lower than 0 .6 mmol/L . • Blood ketone may be higher when you are sick, fasting, have exercised hard, or if glucose levels are not controlled . • If your blood ketone result remains high or becomes higher than 1 .5 mmol/L, contact your health care professional immediately . 49 50 DOC28687_rev-E_manual.indd 49-50 3/30/14 2:52 PM

Display What To Do High Ketone 1.7 mmol L Ketone Test If your blood ketone is high, you will see a message on the screen . You can touch the message button for more information . High Ketone HI mmol L Ketone Test If HI appears on the Reader, your ketone result is higher than 8 mmol/L . You can touch the message button for more information . Repeat the ketone test with a new test strip . If you get a second HI result, contact your health care professional immediately . 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 . IMPORTANT: • Control solution results should fall within the control solution range printed on the test strip instructions for use . • Do NOT use control solution past the expiration date . Discard control solution 3 months after opening . • The control solution range is a target range for control solution only, not for your blood glucose or ketone results . • The control solution test does not reflect your blood glucose or ketone levels . • Use only MediSense glucose and ketone control solution . • Check that the LOT number printed on the test strip foil packet and instructions for use match . • Replace the cap securely on the bottle immediately after use . • Do NOT add water or other liquid to the control solution . • Contact Customer Service for information on how to obtain control solution . 51 Change MediSense to Optium for Australia . 52 DOC28687_rev-E_manual.indd 51-52 3/30/14 2:52 PM

Step Action 1 Ends in 14 days From the Home Screen, touch the Settings 10:23pm symbol . Touch Control Solution Test to do a control solution test . Check Review Glucose History Settings Sounds Target Range Control Solution Test 1 / 3 2 D5 Check the test strip expiration date . 13758 E .g . Expiration date: March 31, 2016 3 Open the foil test strip packet at the notch and tear down to remove the test strip . Step Action 4 Insert the test strip with the three black lines facing up . Push the strip until it stops . 5 Apply Control Solution Shake the control solution bottle to mix the solution . Apply a drop of control solution to the white area at the end of the test strip . If sounds are turned on, the Reader beeps once to let you know that you have applied enough control solution . You will see a butterfly on the screen while you wait for the result . If sounds are turned on, the Reader beeps once when the result is ready . Blo S Abbott Di a b et es C ar e Ltd. Range Road Witney, Oxon, OX 29 0YL Made in UK . 2016/03 53 54 DOC28687_rev-E_manual.indd 53-54 3/30/14 2:52 PM

L dL 10:23pm 100 mg Control Solution Test Blood Glucose Control Solution Test 10:23pm 0.4 mmol Ketone Control Solution Test Control Solution Results Compare the control solution result to the range printed on the test strip instructions for use . The result on your screen should be in this range . Control solution results are marked on the results screen and in the Logbook with a symbol . Note: Repeat the control solution test if the results are outside of the range printed on the test strip instructions for use . Stop using the built-in meter if the control solution results are repeatedly outside of the printed range . Contact Customer Service . 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 . You cannot use the insulin calculator with Sensor glucose readings . An access code is required to set up or change the rapid-acting insulin calculator settings . This access code is available only to your health care professional . Work with your health care professional to set up or change the calculator for you . If you are not sure about the calculator’s suggested dose, you can adjust it based on instructions from your health care professional . Ketone Control Solution Test 55 56 DOC28687_rev-E_manual.indd 55-56 3/30/14 2:52 PM

Step Action 2 to log any rapid-acting Enter information about any Have you forgotten insulin you have taken rapid-acting insulin you may have since X:XX? Enter any rapid- ? forgotten to log . Touch next . acting insulin you have forgotten to log. no yes 2 units How long ago was ? back nethxet unlogged dose of rapid-acting insulin? 15 minutes or less back next Step Action 1 10:23pm Test your blood glucose on your finger . Touch 143 mg results screen . You can also access the insulin calculator by touching the calculator icon next to Rapid-Acting Insulin from the Add Notes Insulin Calculator screen . 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 . If you have added a rapid-acting insulin note to a glucose result without indicating how much insulin you took, the calculator will not be available for up to 8 hours . Insulin Calculator from the blood glucose dL Notes: • You have up to 15 minutes after testing your blood glucose to access the calculator . If the Reader turns off or if you have navigated away from the result screen, you can go to the Logbook and touch add or edit notes to access the calculator from your last blood glucose entry . • If your blood glucose result is below 60 mg/dL, the calculator is not available . • Do not use control solution to obtain a suggested dose . 57 58 DOC28687_rev-E_manual.indd 57-58 3/30/14 2:52 PM

Step Action 3 Breakfast If your calculator was programmed with Easy Setup, touch the meal you plan to eat now . Touch next . Dinner No meal back next Or Enter Carbs ? If your calculator was programmed with Advanced Setup, enter the grams of 20 carbohydrates or servings of carbohydrates grams you plan to eat now . Touch done . back done Or Enter Servings ? 2.0 servings = 30g carbs back done Remove magenta content for France . Step Action 4 Suggested Dose Review your suggested dose . If needed, use the arrow buttons to adjust your suggested dose for any planned activity, a smaller or larger meal, 12u sickness, etc . Touch the symbol to see details User change: of what is included in your suggested dose . +2.0 back log dose Insulin to cover your meal Dose Details OK Insulin to correct for your current For breakfast 9 glucose level For 143 mg/dL +2 Active insulin -1 Insulin remaining in your body User change +2 Total 12u A change you have made to the suggested insulin dose 1 / 2 Your total suggested dose Lunch Adjust if needed 59 60 DOC28687_rev-E_manual.indd 59-60 3/30/14 2:52 PM

Step Action 5 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 . Failure to log all your rapid-acting insulin doses may result in a suggested dose that is too high . Note: The total dose is rounded up or down to the nearest whole number unless your health care professional has changed your Reader to count by half unit steps . 10:23pm Ends in 3 days Check Glucose 8:30am Review History If your health care professional turned on the Active 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 longer it may be active . Touch the symbol to see more information about the remaining rapid-acting insulin from your logged doses . Estimated percentage of active insulin remaining in your body No symbol 100-87% 86-62% 61-37% 36-12% 11-1% 0% 61 62 DOC28687_rev-E_manual.indd 61-62 3/30/14 2:52 PM

Step Action 1 Ends in 14 days To get to the Settings menu, touch the Settings 10:23pm symbol on the Home Screen . Check Review Glucose History Settings Sounds Target Range Control Solution Test 1 / 3 Charging the Reader A fully charged Reader battery should last up to 7 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 of use . Changing the Reader Settings You can go to the Settings menu to change many settings on the Reader, like Time & Date or Sounds . The Settings menu is also where you go to do a Control Solution Test or to check the System Status . Charging Plug the included USB cable into an electrical outlet using the included power adapter . Then, plug the other end of the USB cable into the USB port on the Reader . CAUTION: Be sure to select a location for charging that allows the power adapter to be easily unplugged . Notes: • You must charge the Reader when the battery is low to keep using the Reader . • To fully charge the battery, charge the Reader for at least 3 hours . • Only use the USB cable and power adapter included with the system . • Fully charge your Reader before storing it for more than 3 months . 63 64 DOC28687_rev-E_manual.indd 63-64 3/30/14 2:52 PM

Step Action 2 (cont.) • View Event Logs: A list of events recorded by the Reader, which may be used by Customer Service to help • 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 (including both tones and vibrations) are working, and the Touchscreen is responding when touched Calculator Settings – Review the currently programmed settings (option only available if your health care professional has activated your insulin calculator) Reader Basics – Review the information screens shown during the Reader setup Professional Options – Set by health care professionals only Touch OK when you are done . Step Action 2 Touch the setting you want to change: Sounds – Set tones and vibrations Target Range – Set range displayed on Reader glucose graphs Control Solution Test – Perform a Control Solution test Time & Date – Change the Time or Date Language – Change the language on the Reader (option only available on Readers with multiple languages) System Status – Check Reader information and performance • View System Information: The Reader will display information about your System including: - Current Sensor end date and time - Reader serial number and version number - Serial numbers of most recent Sensors (up to three) - Sensor version for most recent Sensor - Number of Sensors that have been used with Reader - Number of tests that have been performed using test strips 65 66 DOC28687_rev-E_manual.indd 65-66 3/30/14 2:52 PM

Activity What You Need To Know Traveling by Air Check with the airline prior to departure as rules and regulations may change without notice . Follow these guidelines when traveling: • Notify security personnel of the presence of the device when going through security systems . • Do not scan your Sensor or power on the Reader using the Home Button while flying, if restricted by flight regulations . You may insert a strip to perform a blood glucose or ketone test . Note: If you are changing time zones, you can change the time and date settings on the Reader by touching the Settings symbol from the Home Screen, then Time & Date . Changing the time and date affects the graphs, statistics, and settings programmed by time of day . The symbol may appear on your glucose graph indicating the Reader time was changed . Gaps in the graph may result or glucose readings may be hidden . Living With Your FreeStyle Libre System Your FreeStyle Libre Flash Glucose Monitoring System can be used during a wide variety of activities . Activity What You Need To Know Bathing, Showering, and Swimming The Reader is not water-resistant and should NEVER be submerged in water or other liquid . Your Sensor is water-resistant and can be worn while bathing, showering, or swimming . Note: Do NOT take your Sensor deeper than 1 meter (3 feet) or immerse it longer than 30 minutes in water . Sleeping Your Sensor should not interfere with your sleep . It is recommended that you scan your Sensor before going to sleep and when you wake up because your Sensor holds 8 hours of data at a time . If you have reminders set to go off while you are sleeping, place the Reader nearby . 67 68 DOC28687_rev-E_manual.indd 67-68 3/30/14 2:52 PM

Problem What It May Mean What To Do Reader does not power on after you press the Home Button or insert a test strip . Reader battery is too low . Charge the Reader . Reader is outside of its operating temperature range . Move the Reader to a temperature between 10 °C and 45 °C and then try to power it on . Maintenance and Disposal Cleaning You may clean the Reader using a cloth dampened with a mixture of 1 part household bleach to 9 parts water . Gently wipe the exterior of the Reader and allow to air dry . CAUTION: Do NOT place the Reader in water or other liquids . Avoid getting dust, dirt, blood, control solution, water, or any other substance in the test strip or USB ports . Maintenance The FreeStyle Libre Flash Glucose Monitoring System has no serviceable parts . Disposal This product should be disposed of in accordance with all applicable local regulations related to the disposal of electronic equipment, batteries, sharps, and materials potentially exposed to body fluids . Contact Customer Service for further information on the appropriate disposal of system components . 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 If the Reader still does not power on after trying these steps, contact Customer Service . 69 70 DOC28687_rev-E_manual.indd 69-70 3/30/14 2:52 PM

Problem What It May Mean What To Do The Sensor is not sticking to your skin . The site is not free of dirt, oil, hair, or sweat . 1 . Remove the Sensor . 2 . Consider shaving and/or cleaning the site with soap and water . 3 . Follow the instructions in Applying and Starting Your Sensor sections . Skin irritation at the Sensor application site . Seams or other constrictive clothing or accessories causing friction at the site . Ensure that nothing rubs on the site . You may be sensitive to the adhesive material . If the irritation is where the adhesive touches skin, contact your health care professional to identify the best solution . Problems at the Sensor Application Site Problems Starting Your Sensor or Receiving Sensor Readings Display What It May Mean What To Do New Sensor Starting Up Sensor is not ready to read glucose . Wait until the 60 minute Sensor start-up period has completed . Scan Timeout The Reader is not held close enough to the Sensor . Hold the Reader within 4 cm (1 .5 inches) of the Sensor . Bring the screen of the Reader close to the Sensor . Sensor Ended The Sensor life has ended . Apply and start a new Sensor . 71 72 DOC28687_rev-E_manual.indd 71-72 3/30/14 2:52 PM

Display What It May Mean What To Do Glucose Reading Unavailable Your Sensor is too hot or too cold . Move to a location where the temperature is appropriate and scan again in a few minutes . Sensor Already in Use The Sensor was started by another Reader . A Sensor can only be scanned by the Reader that started it . Scan the Sensor again with the Reader that started it . Or, apply and start a new Sensor . Check Sensor The sensor tip may not be under your skin . Try to start your Sensor again . If Reader displays “Check Sensor” again, your Sensor was not applied properly . Apply and start a new Sensor . Replace Sensor The System has detected a problem with your Sensor . Apply and start a new Sensor . Display What It May Mean What To Do New Sensor Found You scanned a new Sensor before your previous Sensor ended . Your Reader can only be used with one Sensor at a time . If you start a new Sensor, you will no longer be able to scan your old Sensor . If you would like to begin using the new Sensor, select “Yes” . Scan Error The Reader was unable to communicate with the Sensor . Try scanning again . Note: You may need to move away from potential sources of electromagnetic interference . Sensor Error The System is unable to provide a glucose reading . Scan again in 10 minutes . 73 74 DOC28687_rev-E_manual.indd 73-74 3/30/14 2:52 PM

Error Message What It May Mean What To Do E-3 Blood drop is too small . or Incorrect test procedure . or There may be a problem with the test strip . 1 . Review the testing instructions . 2 . Repeat the test using a new test strip . 3 . If the error reappears, contact Customer Service . E-4 The blood glucose level may be too high to be read by the system . or There may be a problem with the test strip . 1 . Repeat the test using a new test strip . 2 . If the error reappears, contact your health care professional immediately . Blood Glucose or Ketone Error Messages Error Message What It May Mean What To Do E-1 The temperature is too hot or too cold for the Reader to work correctly . 1 . Move the Reader and test strips to a location where the temperature is within the test strip operating range . (See test strip instructions for use for the appropriate range) . 2 . Wait for the Reader and test strips to adjust to the new temperature . 3 . Repeat the test using a new test strip . 4 . If the error reappears, contact Customer Service . E-2 Reader error . 1 . Turn off the Reader . 2 . Repeat the test using a new test strip . 3 . If the error reappears, contact Customer Service . 75 76 DOC28687_rev-E_manual.indd 75-76 3/30/14 2:52 PM

Error Message What It May Mean What To Do E-7 Test strip may be damaged, used, or the Reader does not recognize it . 1 . Check that you are using the correct test strip for the Reader . (See test strip instructions for use to verify your strip is compatible with the Reader) . 2 . Repeat the test using a test strip for use with your Reader . 3 . If the error reappears, contact Customer Service . E-9 Reader error . 1 . Turn off the Reader . 2 . Repeat the test using a new test strip . 3 . If the error reappears, contact Customer Service . Error Message What It May Mean What To Do E-5 Blood was applied to the test strip too soon . 1 . Review the testing instructions . 2 . Repeat the test using a new test strip . 3 . If the error reappears, contact Customer Service . E-6 The test strip may not be compatible with the Reader . 1 . Check that you are using the correct test strip for the Reader . (See test strip instructions for use to verify your strip is compatible with the Reader) . 2 . Repeat the test using a test strip for use with your Reader . 3 . If the error reappears, contact Customer Service . 77 78 DOC28687_rev-E_manual.indd 77-78 3/30/14 2:52 PM

Problem What It May Mean What To Do The test does not start after applying the blood sample . Blood sample is too small . 1 . See test strip instructions for use for re-application instructions . 2 . Repeat the test using a new test strip . 3 . If the test still does not start, contact Customer Service . Sample applied after the Reader turned off . 1 . Review the testing instructions . 2 . Repeat the test using a new test strip . 3 . If the test still does not start, contact Customer Service . Problem with Reader or test strip . 1 . Repeat the test using a new test strip . 2 . If the test still does not start, contact Customer Service . Problems Checking Your Blood Glucose or Ketone Problem What It May Mean What To Do The Reader does not start a test after inserting a test strip . Test strip is not inserted correctly or not inserted fully into the strip port . 1 . With the 3 black lines facing up, insert the test strip into the strip port until it stops . 2 . If the Reader still does not start a test, contact Customer Service . Reader battery is too low . Charge the Reader . The test strip is damaged, used, or unrecognizable by the Reader . Insert a new FreeStyle Precision/ FreeStyle Optium test strip . Reader is outside of its operating temperature range . Move the Reader to a temperature between 10 °C and 45 °C and then try to power it on . Reader is in a power saving mode . Press the Home Button then insert a test strip . 79 80 DOC28687_rev-E_manual.indd 79-80 3/30/14 2:52 PM

Professional Options Perform a Reader Test Professional Options System Status OK System Info Reader Test Event Log If you think the Reader is not working properly, you can check the Reader by performing a Reader Test . Touch the Options symbol from the Home Screen, select System Status and then select Reader Test . Note: The Reader Test will perform internal diagnostics and will allow you to check that the 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 . Scroll display, sounds, and touchscreen are working properly . System Status Calculator Settings Enter Code to Unlock down using the arrows and touch Professional Options . Enter the A Reader Basics B Professional Options C 1 Professional OK 2 Options Dose Increment 3 Insulin Calculator access code . cancel done Customer Service Customer Service is available to answer any questions you may have about your FreeStyle Libre Flash Glucose Monitoring System . Please go the back cover of this manual for your Customer Service phone number . 81 Note: If you are a health care professional, contact Customer Service for more information . 82 DOC28687_rev-E_manual.indd 81-82 3/30/14 2:53 PM

Professional Options Professional Options + 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 . 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 Dose Increment ? 1 unit 0.5 unit done From the Professional Options screen, select Dose Increment . Then choose 1 unit or 0.5 unit . Touch done . Calculator . CAUTION: This 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 . Complete the setup to store your patient’s individual insulin settings in the Reader . The calculator uses the fingerstick blood glucose results, meal information and the stored settings to calculate a suggested insulin dose based on this formula: Blood glucose correction (if needed) Meal | Carbohydrate Intake Active Insulin (if present) Total = suggested dose 83 84 DOC28687_rev-E_manual.indd 83-84 3/30/14 2:53 PM

Step Action 1 Choose Setup Option Choose the Easy option on the slide bar and touch next . Easy For patients who star t with a Note: You need to know your patient’s fixed dose of rapid-acting insulin at meals. meal-time insulin doses, target glucose range, and correction factor . back next 2 Breakfast ? Enter the meal-time rapid-acting insulin doses . Touch next after each entry . 4 units of insulin back next 3 Correction Target ? Enter the blood glucose Correction Target . This is the desired target range for blood glucose mg values before meals . Touch next . 70 to 130 dL Note: If you just want to set one target instead of a range, set both the low and high values to back next the same number . Professional Options Professional Options 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 servings) to adjust their rapid-acting insulin dose for meals . You must complete all of the steps in the insulin calculator setup in order for the patient to use the calculator . When you have finished setting up the insulin calculator, you can review the settings to make sure they are correct for your patient . You can also review settings at a later time . Touch the Settings symbol from the Home Screen, then select Calculator Settings . Easy Setup of the Insulin Calculator IMPORTANT: If the time on the Reader is wrong, this may lead to an incorrect suggested dose . Remove magenta content for France . 85 86 DOC28687_rev-E_manual.indd 85-86 3/30/14 2:53 PM

10 Professional Options Professional Options Step Action Notes about the Easy Option: • The calculator estimates the amount of rapid-acting insulin still in the 4 Correction Factor ? 1 u insulin for mg dL back next Notes: Enter the Correction Factor (for example: if 1 unit of insulin lowers blood glucose 50 mg/dL, then the correction factor is 50) . If the blood glucose value is outside the blood glucose target, the calculator will use the correction target and factor to calculate a correction dose . 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 . • Both meal and correction doses are included in the active insulin tracking . • Insulin doses calculated 0-2 hours after a previously logged dose • If your patient does not take correction insulin, touch the down arrow to go below 1 to set “No correction insulin” . If you set “No correction insulin”, the calculator only includes meal doses . Additionally, active insulin is not tracked or calculated . • The calculator corrects a blood glucose value to the single target or the average of the target range . • The calculator will not suggest a dose that is estimated to drop the blood glucose below the lower end of the target range or single target . Touch next . Then touch done to complete the setup . You can now review the calculator settings . Touch OK when done . will only include a meal dose . Active insulin will not be subtracted from the meal or carbohydrate dose, and a correction dose will not be included even if the blood glucose is outside the target . During this time period, the previous dose has not reached peak action and additional correction doses, referred to as `insulin stacking’, may result in hypoglycemia . • Insulin doses calculated 2-4 hours after a previously logged dose will have active insulin subtracted from the suggested dose . • All previously injected rapid-acting insulin should be logged to ensure accurate active insulin tracking and calculations . 87 88 DOC28687_rev-E_manual.indd 87-88 3/30/14 2:53 PM

Professional Options Professional Options Calculator Settings - Easy Option This page can be used to record insulin calculator settings . Advanced Setup of the Insulin Calculator Step Action Breakfast Dose units of insulin Lunch Dose units of insulin Dinner Dose units of insulin This is the insulin required to cover food . 1 Choose Setup Option Advanced For patients who count carbs (in gra ms or servings) to adjust their rapid-acting insulin dose at meals. Choose the Advanced option on the slide bar and touch next . Note: You need to know your patient’s meal- time insulin settings, target glucose range, correction factor, and insulin duration . 0-50 0-50 0-50 back next Correction Target _ mg/dL mg/dL 70-180 70-180 Correction Factor This is the desired range for before meal blood glucose . This is the estimated 2 Enter food by: ? Grams of carbs Servings Touch to select how meal/carbohydrate information will be entered . Touch next . For Grams of carbs, go to Step 3 . For Servings, go to Step 4 . 1 unit of insulin for mg/dL 1-99 (or No Correction) amount blood glucose will drop by taking one unit of insulin . back next Changes to these settings can only be made by a health care professional . For France: remove Step 2 & 4 and magenta content in Step 3 . Renumber steps . 89 90 DOC28687_rev-E_manual.indd 89-90 3/30/14 2:53 PM

Step Action 4 Servings Definition ? If you chose to enter Servings in Step 2: The 1 serving = rapid-acting insulin dose suggestion is based on 10.0 servings . grams carbs Enter the Servings Definition (10 to 15 Servings Ratio ? grams of carbs) and touch next . Enter the back next For 1 serving: Servings Ratio ( units of rapid-acting 1.5 insulin per 1 serving) . Touch next when units insulin complete . Optional: by time of day back next Servings ratio ? 2 u ins Note: If you want to set different serving morning ratios for different times of day, touch the 3 u ins 3 u ins night midday option by time of day . Touch each time 4 u ins evening period to change the servings ratio . Touch Servings Ratio OK back done OK after each entry to save . Touch done . For 1 serving: 2 Morning: 4am to 10am Professional Options Professional Options Step Action 3 Carbohydrate Ratio ? If you chose to enter Grams of carbs in Step 2: 1 u insulin for The rapid-acting insulin dose suggestion is based 10 on grams of carbs . grams carbs Optional: by time Enter the Carbohydrate Ratio (1 unit of rapid- of day acting insulin for grams of carbs) . Touch back next next when complete . Carbohydrate ratio ? 1 unit insulin for: 10g Note: If you want to set different morning 15g 15g carbohydrate ratios for different times night midday 20g of day, touch the option by time of day . eveniCnagrbohydrate OK Ratio Touch each time period to change the back done 1 u insulin for 10 carbohydrate ratio . Touch OK after each grams carbs entry to save . Touch done . Morning: 4am to 10am Go to Step 5 . Time of day blocks can not be adjusted . They correspond to the following times: Morning 4:00 AM - 9:59 AM (04:00 - 09:59) Midday 10:00 AM - 3:59 PM (10:00 - 15:59) Evening 4:00 PM - 9:59 PM (16:00 - 21:59) Night 10:00 PM - 3:59 AM (22:00 - 03:59) for 1 serving: units insulin 91 92 DOC28687_rev-E_manual.indd 91-92 3/30/14 2:53 PM

Step Action 5 How does your ? Select how you want your patient to correct their patient correct their glucose? glucose . Touch next . To a single target To a target range back next 6 Correction Target ? Enter the Correction Target value or range . This 100 is the desired target value or range for blood glucose values before meals . Touch next when mg/dL complete . Optional: by time of day back Correncetxiot n Target ? in mg/dL: Note: If the Correction Target is 100 morning based on time of day, touch the 120 110 night midday option by time of day . Touch each 100 time period to change the correction evening back Corrdeocntieon Target OK target for that period . Touch OK after each entry to save . Touch done . 100 mg/dL Morning: 4am to 10am 10 10 Professional Options Professional Options Step Action 7 Correction Factor ? 1 u insulin for mg dL Enter the Correction Factor (for example: if 1 unit of insulin lowers blood glucose 50 mg/dL, then the correction factor is 50) . If the blood glucose reading is outside the blood glucose Optional: Correction factor by time of day ? target, the calculator will use the correction 1 u insulin fboarc: k next 10 mg/dL morning target and factor to calculate a correction dose . Touch next when complete . 20 mg/dL night 20 mg/dL midday 15 mg/dL evening back done Correction Factor OK 1 u insulin for mg dL Morning: 4am to 10am Notes: • If the Correction Factor is based on time of day, touch the option by time of day . Touch each time period to change the correction factor for that period . Touch OK after each entry to save . Touch done . • The calculator corrects a blood glucose value to the single target or the average of the target range . • The calculator will not suggest a dose that is estimated to drop the blood glucose below the lower end of the target range or single target . 93 94 DOC28687_rev-E_manual.indd 93-94 3/30/14 2:53 PM

Step Action 9 Do you want the ? Select whether or not to show the Active Insulin Active Insulin symbol to be displayed on the symbol on the Home Screen . Home Screen? Yes This symbol shows an estimate of the amount No of rapid-acting insulin still in the body and how much longer it may be active . If you select “No”, back next active insulin is still included in the suggested dose calculation . Touch next . Then touch done to complete the setup . You can now review the calculator settings . Touch OK when done . Professional Options Professional Options Step Action 8 Insulin Duration ? Enter the Insulin Duration . This is the amount of 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 person1 . The Reader allows an insulin duration from 3-8 hours . 1 Product Inserts: HumaLog®, NovoLog®, Apidra® 95 96 DOC28687_rev-E_manual.indd 95-96 3/30/14 2:53 PM

Professional Options Professional Options % active insulin 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 . • Both meal and correction doses are included in the active insulin tracking . • Insulin doses calculated 0-2 hours after a previously logged dose will only include a meal dose . Active insulin will not be subtracted from the meal or carbohydrate dose, and a correction dose will not be included even if the blood glucose is outside the target . During this time period, the previous dose has not reached peak action and additional correction doses, referred to as `insulin stacking’, may result in hypoglycemia . • Insulin doses calculated between 2 hours and the set insulin duration will have active insulin subtracted from the suggested dose (for example if insulin duration is set at 5 hours, active insulin will be subtracted from doses calculated between 2-5 hours) . • All previously injected rapid-acting insulin should be logged to ensure accurate active insulin tracking and calculations . 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 100 90 80 70 60 50 40 30 20 10 0 10 20 30 40 50 60 70 80 90 100 % insulin duration Adapted from Mudaliar et al . Diabetes Care, Volume 22(9), Sept 1999, pp 1501-1506 97 98 DOC28687_rev-E_manual.indd 97-98 3/30/14 2:53 PM

Professional Options Professional Options Calculator Settings - Advanced Option This page can be used to record insulin calculator settings . Correction Factor 1 unit of insulin for This is the estimated amount blood glucose will drop by taking one unit of insulin . (Option to enter by Carbohydrate Ratio 1 unit of insulin for grams of carbs OR 1-50 Servings Definition grams of carbs 10-15 This is the number of grams of carbs that one unit of rapid-acting insulin will cover OR the number of units of rapid-acting insulin that will cover one serving . (Option to enter by time of day .) Servings Ratio For 1 serving take units of insulin 0.5-15 mg/dL 1-99 Insulin Duration Insulin is active in the body for hours:mins 3-8 time of day .) This is the amount of time that a dose of rapid-acting insulin remains active in the body . Correction Target mg/dL 70-180 OR Correction Target Range to This is the desired target or range for before meal blood glucose . (Option to enter by time of day .) Active Insulin feature? Yes No mg/dL mg/dL 70-180 70-180 99 Remove magenta content for France . Changes to these settings can only be made by a health care professional . 100 DOC28687_rev-E_manual.indd 99-100 3/30/14 2:53 PM

Step Action 1 From the Home Screen, touch the Settings System Status symbol . Scroll down using the arrows and touch Professional Options . Enter the access Calculator Settings code . Touch Insulin Calculator . Reader Basics Professional Options 2 Calculator Settings Touch Turn Off Calculator to turn off the insulin calculator or Change Calculator Settings to Turn Off Calculator change the insulin calculator settings . Change Calculator Settings Note: If you turn off the insulin calculator, your patient will no longer see the calculator back button after a blood glucose test . You can turn the calculator back on by repeating the insulin calculator setup . Professional Options Changing the Insulin Calculator Settings System Specifications See test strip and control solution instructions for use for additional specifications . Sensor Specifications Sensor glucose assay method Amperometric electrochemical sensor Sensor glucose reading range 40 to 500 mg/dL Sensor size 5 mm height and 35 mm diameter Sensor weight 5 grams Sensor power source One silver oxide battery 101 102 DOC28687_rev-E_manual.indd 101-102 3/30/14 2:53 PM

Sensor life Up to 14 days Sensor memory 8 hours (glucose readings stored every 15 minutes) Operating temperature 10 °C to 45 °C Sensor Applicator and Sensor Pack storage temperature 4 °C to 30 °C Operating and storage relative humidity 10-90%, non-condensing Sensor water resistance IP27: Can withstand immersion into one meter (3 ft) of water for up to 30 minutes Operating and storage altitude -381 meters (-1,250 ft) to 3,048 meters (10,000 ft) Reader Specifications Blood glucose assay range 20 to 500 mg/dL 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 7 days of typical use Reader memory 90 days of typical use Reader operating temperature 10 °C to 45 °C Reader storage temperature -20 °C to 60 °C 103 104 DOC28687_rev-E_manual.indd 103-104 3/30/14 2:53 PM

Operating and storage relative humidity 10-90%, non-condensing Reader moisture protection Keep dry Operating and storage altitude -381 meters (-1,250 ft) to 3,048 meters (10,000 ft) Reader display timeout 60 seconds (120 seconds when test strip is inserted) Radio Frequency 13 .56 MHz Data port Micro USB Minimum Computer Requirements System must only be used with EN60950-1 rated computers Mean service life 3 years of typical use Power Adapter Abbott Diabetes Care PRT25612 (UK plug) PRT25613 (EU Plug) PRT25847 (Australia plug) PRT25611 (Canada plug) Operating temperature: 10 °C to 40 °C USB Cable Abbott Diabetes Care PRT21373 Length: 94 cm (37 inches) Rapid-Acting Insulin Calculator Specifications Parameter Unit Range or Value Correction target mg/dL 70 to 180 Carbohydrate ratio 1 unit per X grams of carbs 1 to 50 Servings ratio Units of insulin per serving 0 .5 to 15 Servings definition Grams of carbs 10 to 15 Mealtime insulin doses (breakfast, lunch, dinner) Units of insulin 0 to 50 Correction factor 1 unit per X mg/dL 1 to 99 Insulin duration (duration of insulin action) Hours Easy: 4 Advanced: 3 to 8 105 106 DOC28687_rev-E_manual.indd 106 3/30/14 2:53 PM

Parameter Unit Range or Value Dose increments Units of insulin 0 .5 or 1 Maximum insulin dose Units of insulin 50 Consult instructions for use Use-by date Temperature limit Catalog number Manufacturer Serial number CE Mark Do not use if package is damaged Batch code Keep dry Type BF applied part Non-ionizing radiation CODE Sensor code Caution Do not re-use Sterilized using irradiation This product must not be disposed of via municipal waste collection . Separate collection for electrical and electronic equipment waste per Directive 2012/19/EC in the European Union is required . Contact the manufacturer for details . Labeling Symbols Remove magenta content for France . 107 May or may not be present or may vary per RA requirements . 108 DOC28687_rev-E_manual.indd 107-108 3/30/14 2:53 PM

Emissions test Compliance Electromagnetic environment – guidance RF emissions CISPR 11 Group 1 The System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions CISPR 11 Class B The System is suitable for use in all establishments, including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes. Harmonic emissions IEC 61000-3-2 Class A Voltage fluctuations / flicker emissions IEC 61000-3-3 Complies Include for Canada Electromagnetic Compatibility • The System needs special precautions regarding EMC and needs to be installed and put into service according to the 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. • The System should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the System should be observed to verify normal operation in the configuration in which it will be used. • This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. • Changes or modifications not approved by Abbott could void the user’s authority to operate the equipment. 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. 109 110 DOC28687_rev-E_manual.indd 109-110 3/30/14 2:53 PM

IMMUNITY test IEC 60601 test level Compliance Level Electromagnetic environment – guidance Surge IEC 61000-4-5 ±1 kV differential mode ±2 kV common mode ±1 kV differential mode ±2 kV common mode Mains power quality should be that of a typical domestic, commercial, or hospital environment. Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 <5 % UT (>95 % dip in UT) for 0.5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 seconds <5 % UT (>95 % dip in UT) for 0.5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 seconds Mains power quality should be that of a typical domestic, commercial, or hospital environment. If the user of the System requires continued operation during power mains interruptions, it is recommended that the System be powered from an uninterruptible power supply or a battery. 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 test IEC 60601 test level Compliance Level Electromagnetic environment – guidance Electrostatic discharge (ESD) IEC 61000-4-2 ± 6 kV contact ± 8 kV air ± 6 kV contact ± 8 kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Electrical fast transient/burst IEC 61000-4-4 ± 2 kV for power supply lines ± 1 kV for input/ output lines ± 2 kV for power supply lines ± 1 kV for input/ output lines Mains power quality should be that of a typical domestic, commercial, or hospital environment. 111 112 DOC28687_rev-E_manual.indd 111-112 3/30/14 2:53 PM

IMMUNITY test IEC 60601 test level Compliance Level Electromagnetic environment – guidance Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz 3 Vrms Portable and mobile RF communications equipment should be used no closer to any part of the System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.2 IMMUNITY test IEC 60601 test level Compliance Level Electromagnetic environment – guidance Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical domestic, commercial, or hospital environment. NOTE UT is the a.c. mains voltage prior to application of the test level. 113 114 DOC28687_rev-E_manual.indd 113-114 3/30/14 2:53 PM

IMMUNITY test IEC 60601 test level Compliance Level Electromagnetic environment – guidance Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.5 GHz 3 V/m Recommended separation distance d = 1.2 80 MHz to 800 MHz d = 2.3 800 MHz to 2.5 GHz a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the System is used exceeds the applicable RF compliance level above, the System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the System. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 115 116 DOC28687_rev-E_manual.indd 115-116 3/30/14 2:53 PM

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. For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d = 1.2 80 MHz to 800 MHz d = 1.2 800 MHz to 2.5 GHz d = 2.3 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 117 118 DOC28687_rev-E_manual.indd 117-118 3/30/14 2:53 PM

Hereby, Abbott Diabetes Care Ltd, declares that the FreeStyle Libre Flash Glucose Monitoring System is in compliance with the essential requirements and other relevant provisions of the R&TTE Directive . A copy of the original declaration of conformity may be obtained from Abbott Diabetes Care Ltd ., Range Road, Witney, Oxon, OX29 0YL, UK . Font License ©2013 Abbott Licensed under the Apache License, Version 2 .0 (the “License”); you may not use this file except in compliance with the License . You may obtain a copy of the License at: http://www .apache .org/licenses/LICENSE-2 .0 Unless required by applicable law or agreed to in writing, software distributed under the License is distributed on an “AS IS” BASIS, WITHOUT WARRANTIES OR CONDITIONS OF ANY KIND, either express or implied . See the License for the specific language governing permissions and limitations under the License . May or may not be present or may vary per RA requirements . 119