FCC ID: QXS-LIB02 Glucose Monitoring Reader

4.6 4.6 Distributed by:

Abbott Diabetes Care Inc. 1360 South Loop Road Alameda, CA 94502 USA Customer Service: 1-855-632-8658 Monday through Friday, 8AM to 8PM Eastern Standard Time www.FreeStyleLibre.com 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 Users Manual FLASH GLUCOSE MONITORING SYSTEM Manufacturer:

2018 Abbott DOC40395 Rev. A 10/18 CAUTION: Federal law restricts this device to sale by or on the order of a physician. DOC40395_rev-A_cover.indd 1-2

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.224 10/23/18 1:16 PM 4.6 4.6 Your Name _________________________________________________ DOC40395_rev-A_cover.indd 3-4

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.224 10/23/18 1:16 PM Contents Important Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Indications For Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Cautions and Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Reader Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Getting to Know Your System . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Reader Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Sensor Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 FreeStyle Libre Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Setting up Your Reader for the First Time . . . . . . . . . . . . . . 18 Using Your Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Applying Your Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Starting Your Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Checking Your Glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Making Treatment Decisions . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Making Treatment Decisions Getting Started . . . . . . . . . . 34 Making Treatment Decisions Advanced . . . . . . . . . . . . . . . . 39 DOC40395_rev-A_manual.indd 1 10/23/18 1:16 PM Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 Setting Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 Setting Alarm Sounds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 Using Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 Adding Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 Reviewing Your History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 Logbook . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 Daily Graph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 Other History Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66 Removing Your Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68 Replacing Your Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 Living With Your System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90 Maintenance and Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98 Reader Does Not Power On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98 Problems at the Sensor Application Site . . . . . . . . . . . . . . . . . 99 Problems Starting Your Sensor or Receiving Sensor Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100 Problems Receiving Glucose Alarms . . . . . . . . . . . . . . . . . . . . 104 Blood Glucose Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . .106 Problems Checking Your Blood Glucose . . . . . . . . . . . . . . . . . 110 Perform a Reader Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112 Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112 Using Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70 System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .113 Using the Readers Built-in Meter . . . . . . . . . . . . . . . . . . . . . . 72 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72 Blood Glucose Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75 Control Solution Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81 Labeling Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .118 Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . .120 Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . . . 138 Charging the Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86 Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151 Changing the Reader Settings . . . . . . . . . . . . . . . . . . . . . . . . . 87 DOC40395_rev-A_manual.indd 2-3 10/23/18 1:16 PM Important Safety Information Indications For Use The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device indicated for the management of diabetes in persons age 18 and older . It is designed to replace blood glucose testing for diabetes treatment decisions . The System detects trends and tracks patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments . Interpretation of the System readings should be based on the glucose trends and several sequential readings over time . The System is intended for single patient use and requires a prescription . Contraindications MRI/CT/Diathermy: The System must be removed prior to Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment . The effect of MRI, CT scans, or diathermy on the performance of the System has not been evaluated . The exposure may damage the Sensor and may impact proper function of the device which could cause incorrect readings . 1 DOC40395_rev-A_manual.indd 1-2 WARNINGS:

Do not ignore symptoms that may be due to low or high blood glucose: If you are experiencing symptoms that are not consistent with your glucose readings, consult your health care professional . Check Sensor glucose readings by conducting a fingerstick test with a blood glucose meter under the following conditions, when Sensor glucose readings may not be accurate and should not be used to make a diabetes treatment decision:

If you suspect that your reading may be inaccurate for any reason When you are experiencing symptoms that may be due to low or high blood glucose When you are experiencing symptoms that do not match the Sensor glucose readings During the first 12 hours of wearing a FreeStyle Libre 2 Sensor During times of rapidly changing glucose (more than 2 mg/dL per minute) When the Sensor glucose reading does not include a Current Glucose number or Glucose Trend Arrow In order to confirm hypoglycemia or impending Glucose Going Low hypoglycemia as reported by the Sensor When you see the symbol, you must check your blood glucose with a blood glucose meter before making any treatment decisions . Sensor readings may not accurately reflect blood glucose levels . 82 mg dL 350 250 150 50 2pm 6pm 10pm 2 10/23/18 1:16 PM WARNINGS: (cont.) Choking hazard: The System contains small parts that may be dangerous if swallowed . Cautions and Limitations Below are important cautions and limitations to keep in mind so you can use the System safely . They are grouped into categories for easy reference . What to know about Glucose Alarms:

For you to receive alarms, they must be on and your Reader should be within 20 feet of you at all times . The transmission range is 20 feet unobstructed . If you are out of range, you may not receive glucose alarms . To prevent missed alarms, make sure the Reader has sufficient charge and that sound and/or vibration are turned on . What to know before using the System:

Review all product information before use . Take standard precautions for transmission of blood borne pathogens to avoid contamination . 3 DOC40395_rev-A_manual.indd 3-4 Who should not use the System:

Do not use the System in people less than 18 years of age. The System is not approved for use in people under 18 years of age and Sensor readings in this population may be inaccurate . In general, continuous glucose monitoring systems are recognized to be less accurate in children than in adults . Do not use the System in critically ill patients. The System is not approved for use in these patients . It is not known how different conditions or medications common to the critically ill population may affect performance of the System . Sensor glucose readings may be inaccurate in critically ill patients . Do not use the System in pregnant women or persons on dialysis. The System is not approved for use in pregnant women or persons on dialysis and has not been evaluated in these populations . Performance of the System when used with other implanted medical devices, such as pacemakers, has not been evaluated . What should you know about wearing a Sensor:

The Sensor can be worn for up to 14 days . Some individuals may be sensitive to the adhesive that keeps the Sensor attached to the skin . If you notice significant skin irritation around or under your Sensor, remove the Sensor and stop using the System . Contact your health care professional before continuing to use the System . 4 10/23/18 1:16 PM Intense exercise may cause your Sensor to loosen due to sweat or movement of the Sensor . Remove and replace your Sensor if it starts to loosen and follow the instructions to select an appropriate application site . The System uses all available glucose data to give you readings so you should scan your Sensor at least once every 8 hours for the most accurate performance . Scanning less frequently may result in decreased performance . 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-sterilization . Further exposure to irradiation may cause inaccurate results . If a Sensor breaks inside your body, call your health care professional . How to Store the Sensor Kit:

Store the Sensor Kit between 39F and 77F . Storage outside of this range may cause inaccurate Sensor glucose readings . While you dont need to keep your Sensor Kit in a refrigerator, you can as long as the refrigerator is between 39F and 77F . Do not freeze . Store the Sensor Kit between 10-90% non-condensing humidity . When not to use the System:

Do NOT use if the Sensor Kit package, Sensor Pack, or Sensor Applicator appear to be damaged or already opened due to risk of no results and/or infection . 5 DOC40395_rev-A_manual.indd 5-6 Do NOT use if Sensor Kit contents are past expiration date . Do NOT use if the Reader appears to be damaged due to risk of electric shock and/or no results . What to know before you Apply the Sensor:

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 . Do not use Sensor Packs and Sensor Applicators with different Sensor codes together as this will result in incorrect glucose readings . A b b o t t D i a b e t e CODE FreeStyle Libre Sensor Pack XXX XXXXXXXXX YYYY-MM-DD Clean the application site and ensure that it is dry prior to Sensor s C insertion . This helps the Sensor stay attached to your body . Clean hands prior to Sensor handling/insertion to help prevent are Ltd. Range Road, Witney, Ox o n , O X infection . Change the application site for the next Sensor application to prevent discomfort or skin irritation . Sensor placement is not approved for sites other than the back of the arm . If placed in other areas, the Sensor may not function properly . Select an appropriate Sensor site to help the Sensor stay attached to the body and prevent discomfort or skin irritation . Avoid areas with scars, moles, stretch marks, or lumps . Select an area of skin 6 10/23/18 1:16 PM 3 Y L, U K DOC30391 Rev. B 09/1 9 0 2 that generally stays flat during normal daily activities (no bending or folding) . Choose a site that is at least 1 inch away from an insulin injection site . When is Sensor Glucose different from Blood Glucose:

Physiological differences between the interstitial fluid and capillary blood may result in differences in glucose readings between the System and results from a fingerstick test using a blood glucose meter . 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 . What to know about interfering substances such as Vitamin C and Aspirin:

Taking ascorbic acid (vitamin C) while wearing the Sensor may falsely raise Sensor glucose readings . Taking salicylic acid (used in some pain relievers such as aspirin and some skin care products) may slightly lower Sensor glucose readings . The level of inaccuracy depends on the amount of the interfering substance active in the body . Test results did not indicate interference for methyldopa (used in some drugs to treat high blood pressure) or tolbutamide (infrequently used in some drugs to treat diabetes in the US) at maximum circulating levels . However, concentrations of potential interferents in interstitial fluid are unknown compared to circulating blood . 7 DOC40395_rev-A_manual.indd 7-8 What to know about X-Rays:

The Sensor should be removed prior to exposing it to an X-ray machine . The effect of X-rays on the performance of the System has not been evaluated . The exposure may damage the Sensor and may impact proper function of the device to detect trends and track patterns in glucose values during the wear period . When to remove the Sensor:

If the Sensor is becoming loose or if the Sensor tip is coming out of your skin, you may get no readings or unreliable readings, which may not match how you feel . Check to make sure your Sensor has not come loose . If it has come loose, remove it and apply a new one . 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 . What to do if you are dehydrated:

Severe dehydration and excessive water loss may cause inaccurate Sensor glucose readings . If you believe you are suffering from dehydration, consult your health care professional immediately . 8 10/23/18 1:16 PM What to know about the Readers Built-in Meter:

The FreeStyle Libre 2 Reader has a built-in blood glucose meter that is designed to be used only with FreeStyle Precision Neo blood glucose test strips and MediSense Glucose and Ketone Control Solution . Using other test strips with the Readers built-in meter will produce an error or cause the Readers built-in meter to not turn on or start a test . The Readers built-in meter does not have ketone testing functionality . The Readers built-in meter is not for use on people who are dehydrated, hypotensive, in shock, or for individuals in hyperglycemic-

hyperosmolar state, with or without ketosis . The Readers built-in meter is not for use on neonates, in critically-ill patients, or for diagnosis or screening of diabetes . See Using the Readers Built-in meter section for additional important information on the use of the Readers built-in meter . Where to charge your Reader:

Be sure to select a location for charging that allows the power adapter to be easily unplugged . Do NOT block access to the charger due to the potential risk of electrical shock . Reader Symbols Symbol What It Means Sensor may be inaccurate . Check blood glucose with a test strip before making any treatment decisions Active Sensor Direction your glucose is going . See Checking Your Glucose section for more information . Caution View previous/next screen Sound and Vibration ON Sound ON, Vibration OFF Sound OFF, Vibration ON Sound and Vibration OFF Sensor communicating with Reader Sensor not communicating with Reader 9 DOC40395_rev-A_manual.indd 9-10 10 10/23/18 1:16 PM Symbol What It Means Notes

Add more information to notes Food note Rapid-acting insulin note Time changed on Reader Blood glucose test Settings Control solution test result Low battery Battery charging Sensor too cold Sensor too hot 11 DOC40395_rev-A_manual.indd 11-12 Getting to Know Your System The FreeStyle Libre 2 System (System) has two main parts: a handheld Reader and a disposable Sensor that you wear on your body . 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 . When theyre in range, the Sensor and Reader automatically communicate to give you glucose alarms . These alarms are on by default . IMPORTANT:

Before you use your System, review all the product instructions and the Interactive Tutorial . The Quick Reference Guide and Interactive Tutorial give you quick access to important aspects and limitations of the System . The Users Manual includes all safety information and instructions for use . During the first 12 hours after insertion of a Sensor, Sensor readings is displayed, a will be accompanied by the blood glucose test should be performed to confirm the Sensor reading prior to treatment . symbol . Whenever Talk to your health care professional about how you should use your Sensor glucose information to help manage your diabetes . 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 . 12 10/23/18 1:16 PM Reader Kit The Reader Kit includes:

FreeStyle Libre 2 Reader USB Cable Interactive Tutorial on USB USB Port Used to charge the Reader and connect it to a computer. Power Adapter Users Manual Quick Start Guide Quick Reference Guide Touchscreen Test Strip Port Insert a test strip here to use the built-in meter. Home Button Turns the Reader on/off and takes you to the Home screen from any other screen. The Reader gets glucose readings from your Sensor and can issue glucose alarms . 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 . The Reader also includes a built-in meter for blood glucose testing . 13 DOC40395_rev-A_manual.indd 13-14 Sensor Kit The Sensor Kit includes:

Sensor Pack Sensor Applicator Alcohol wipe Product insert Sensor Pack Used with the Sensor Applicator to prepare the Sensor for use . Sensor Applicator Applies the Sensor to your body . 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 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). 14 10/23/18 1:16 PM 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 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 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 Sound/Vibration setting Signal Status Shows if Sensor is communicating with Reader. Settings Touch to access Alarms, Reminders, and other Reader settings. Review History Touch to review information about your past glucose readings. Note: Sound/Vibration setting and Signal Status symbols only display when any alarm is on . 15 DOC40395_rev-A_manual.indd 15-16 Message Touch for more information. Current Glucose Glucose from your latest scan. Check Blood Glucose symbol Touch for more information. Glucose Going Low 82 mg dL 350 250 150 50 Food Note 2pm 6pm 10pm Add Notes Touch to add notes to the glucose reading. Glucose Trend Arrow Direction your glucose is going. Rapid-Acting Insulin Note Glucose Graph Graph of your current and stored glucose readings. 16 10/23/18 1:16 PM 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 . 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, and other data uploaded from the FreeStyle Libre 2 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 . Setting up Your Reader for the First Time Before using the System for the first time, the Reader must be set up . Step 1 2 Action Press the Home Button to turn on the Reader . 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 . 17 DOC40395_rev-A_manual.indd 17-18 18 10/23/18 1:16 PM Step 3 Action Current Date Set the Current Date using the arrows on the touchscreen . Touch next to continue . Step 5 14 June 2019 back next Action The Reader now displays important information about key topics to help you use the System:

How to understand the Glucose Trend Arrow included on the Glucose Reading screen . When to do a blood glucose test . Where to apply the Sensor . How to return to the Home Screen from any other screen . 4 Current Time Set the Current Time . Touch next to continue . 12 am 00 back next CAUTION: It is very important to set the time and date correctly . These values affect the Reader data and settings . 19 DOC40395_rev-A_manual.indd 19-20 When you scan your Sensor an arrow will indicate your recent glucose trend:

Rising quickly Rising Changing slowly Falling Falling quickly If you see this symbol, do a blood glucose test before making treatment decisions. If the Sensor glucose reading does not match how you feel, do a blood glucose test. The Sensor can only be applied to the back of your upper arm. back next While using the Reader, press the Home Button to return to the Home Screen. back next back next back next back done Touch next to move to the next topic . At the end of the Reader setup, touch done to go to the Home Screen . Note: Charge the Reader if the battery level is low . Only use the USB cable and power adapter included with the System . 20 10/23/18 1:16 PM 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 . Do not use Sensor Packs and Sensor Applicators with different Sensor codes together as this will result in incorrect glucose readings . CODE FreeStyle Libre Sensor Pack XXX XXXXXXXXX YYYY-MM-DD Intense exercise may cause your Sensor to loosen due to sweat or movement of the Sensor . Remove and replace your Sensor if it starts to loosen and follow the instructions to select an appropriate application site . are Ltd. Range Road, Witney, Ox o n , O X e t e s C i a t t b D o b A b 3 Y L, U K DOC30391 Rev. B 09/1 9 0 2 Step 1 2 Action Apply Sensors only on the back of your upper arm . If placed in other areas, the Sensor may not function properly and could give inaccurate readings . The application of the Sensor is not approved for other sites . 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 1 inch

(2 .5 cm) 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 . 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 . 21 DOC40395_rev-A_manual.indd 21-22 22 10/23/18 1:16 PM Step 3 Lid Cap Action 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 . Do NOT use if past expiration date . 4 5 Line up the dark mark on the Sensor Applicator with the dark mark on the Sensor Pack . On a hard surface, press firmly down on the Sensor Applicator until it comes to a stop . Lift the Sensor Applicator out of the Sensor Pack . Step 6 7 Action 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 . CAUTION: Do NOT push down on the Sensor Applicator until placed over prepared site to prevent unintended results or injury . 23 DOC40395_rev-A_manual.indd 23-24 24 10/23/18 1:16 PM Step 8 Sensor Action Gently pull the Sensor Applicator away from your body . The Sensor should now be attached to your skin . Note: Applying the Sensor may cause bruising or bleeding . If there is bleeding that does not stop, remove the Sensor and contact your health care professional . 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 . Starting Your Sensor Step Action 1 2 3 Press the Home Button to turn on the Reader . Touch Start New Sensor . 10:23pm No Active Sensor Start New Sensor Review History Hold the Reader within 1 .5 inches (4 cm) of the Sensor to scan it . This starts your Sensor . If sounds are turned on, the Reader beeps when the Sensor 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 . OK New Sensor Starting Up Sensor can be used in:

60 minutes 25 DOC40395_rev-A_manual.indd 25-26 26 10/23/18 1:16 PM Step 3 Glucose Going High 236 mg dL 350 250 150 50 6am 10am 2pm Action The Reader displays your current glucose reading along with your glucose graph and an arrow indicating the direction your glucose is going . Checking Your Glucose Step 1 2 Action OR 10:23pm Ends in 14 days Check Glucose Review History Turn the Reader on by pressing the Home Button or touch Check Glucose from the Home Screen . Hold the Reader within 1 .5 inches (4 cm) 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 . 27 DOC40395_rev-A_manual.indd 27-28 28 10/23/18 1:16 PM Sensor Glucose Readings The Glucose Trend Arrow gives you an indication of the direction your glucose is going . Check Blood Glucose When you see this symbol, do a blood glucose test before making treatment decisions. Target Glucose Range Your Target Glucose Range is not related to your glucose alarm settings. Glucose Going Low 82 mg dL Glucose Trend Arrow Current Glucose 350 250 150 50 2pm 6pm 10pm Notes:

While Sensor glucose readings are gathered in the System range of 40-500 mg/dL, the graph display range is 0-350 mg/dL for ease of review on screen . Glucose readings above 350 mg/dL are displayed at 350 mg/dL . For sequential readings above 350 mg/dL, a line is displayed at 350 mg/dL . symbol may appear, indicating the Reader time was changed . The Gaps in the graph may result or glucose readings may be hidden . All available glucose data is used to make your graph so you can expect to see some differences between the graph line and previous current glucose readings . 29 DOC40395_rev-A_manual.indd 29-30 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) Note: The Glucose Trend Arrow may not always appear with your reading . 30 10/23/18 1:16 PM The following table shows messages you may see with your glucose readings . What To Do 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 . 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 . Display Low Glucose LO mg dL 350 250 150 50 350 250 150 50 High Glucose 10pm HI mg dL 2pm 6pm 350 250 150 50 2pm 6pm 10pm Low Glucose dL63 mg High Glucose 10pm 289 mg dL 350 250 150 50 2pm 6pm 10pm 2pm 6pm 31 DOC40395_rev-A_manual.indd 31-32 Display Glucose Going Low dL72 mg Glucose Going High 350 250 150 50 2pm 6pm 10pm 237 mg dL 350 250 150 50 2pm 6pm 10pm Low Glucose dL63 mg 350 250 150 50 2pm 6pm 10pm What To Do 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 . if your glucose You will see this symbol reading is less than 70 mg/dL, projected to be less than 70 mg/dL, rapidly changing, has no number or trend arrow, or it is in the first 12 hours after inserting the Sensor . You can touch the symbol for more information . Check your blood glucose on your finger with a test strip before making treatment decisions . Notes:

If you are not sure about a message or reading, contact your health Messages you receive with your glucose readings are not related to care professional before you do anything . your glucose alarm settings . 32 10/23/18 1:16 PM Making Treatment Decisions Work with your health care professional to put together a plan for managing your diabetes that includes when to use the System information for making treatment decisions . WARNING: The System can replace blood glucose testing except in a few situations . These are the times when you need to do a blood glucose test before deciding what to do or what treatment decision to make as Sensor readings may not accurately reflect blood glucose levels:

Do a blood glucose test if you see the Check Blood Glucose symbol . The means your Sensor glucose reading may not be accurate . For example, there may be times when you get a low glucose reading but you do not actually have low glucose . symbol Do a blood glucose test if you think your glucose readings are not correct or do not match how you feel . Do not ignore symptoms that may be due to low or high glucose . Note: The situation . symbol will NOT appear in this 33 Making Treatment Decisions Getting Started Before you start using the System for treatment decisions, make sure you have a good understanding of how the System works for your body . Continue to use your blood glucose meter for treatment decisions until you are comfortable with the information you receive from your System. This includes understanding that: Sensor performance can vary in between Sensors, within a Sensor wear, and in different situations . Getting familiar with the System could take days, weeks, or even months . The more you check readings from the System with a blood glucose meter, the better you will understand how the System works for you . Work with your health care professional to put together a plan for managing your diabetes that includes when to use the System information for making treatment decisions . Helpful Tips Confirm your Sensor glucose readings with a blood glucose meter until you understand:

Sensor accuracy may vary between Sensors . Sensor accuracy may vary during a Sensor wear session . Sensor accuracy may vary in different situations (meals, exercise, first day of use, etc .) Scan your Sensor often to see how carbs, medication, exercise, illness, or stress levels impact your Sensor glucose readings . The information you get can help you figure out why your glucose sometimes goes too high or too low, and how to prevent it from doing so in the future . 34 DOC40395_rev-A_manual.indd 33-34 10/23/18 1:16 PM Talk to your health care professional about how your insulin works . The more you understand about your insulin, including how long it takes to start working and how long it lasts in your body, the more likely you will be to make better treatment decisions . Making a treatment decision doesnt just mean taking insulin . Treatment decisions can also include things like taking fast-acting carbs, eating, or even doing nothing and scanning again later . Your health care professional can also help you to understand when doing nothing and scanning again later is the right treatment decision . For example, if your glucose is high and going up, your first instinct may be to take more insulin to lower your glucose, however depending on when you last took insulin or your recent activity, the right treatment decision may be to do nothing and scan again later . Avoid insulin stacking . When not to use Sensor Glucose readings for treatment decisions Glucose is Falling Quickly or Rising Quickly Sensor glucose values, which are based on interstitial fluid glucose levels, can be different from blood glucose levels (fingersticks), particularly during times when your blood glucose is changing quickly . For example after eating, taking insulin, or exercising . When glucose levels are falling quickly, glucose readings from the Sensor may be higher than blood glucose levels . On the other hand, when glucose levels are rising quickly, glucose readings from the Sensor may be lower than blood glucose levels . 35 DOC40395_rev-A_manual.indd 35-36 If glucose is rising quickly or falling quickly, you will see the Whenever you see the based on that result . symbol, do a blood glucose test and treat symbol . Glucose Rising Quickly Sensor Glucose 80 mg/dL Blood Glucose 70 mg/dL Blood Glucose 100 mg/dL Sensor Glucose 95 mg/dL Glucose Falling Quickly Low Glucose or Glucose Going Low message The System lets you know about hypoglycemia or impending hypoglycemia with a Low Glucose or Glucose Going Low message . These messages may not accurately reflect blood glucose . When there is a Low Glucose or Glucose Going Low message, you will also see the Whenever you see the based on that result . symbol, do a blood glucose test and treat symbol . No Glucose Trend Arrow When there is no Glucose Trend Arrow, the System cant tell if your glucose is rising quickly or falling quickly and will display the Whenever you see the and treat based on that result . symbol, you should do a blood glucose test symbol . 36 10/23/18 1:16 PM No Current Glucose Number When there is no Current Glucose number, such as when you receive an error message or a LO or HI result, you dont have enough information to make a treatment decision . When there is no Current Glucose you will see the test and treat based on that result . symbol . Whenever you see the symbol, do a blood glucose During the first 12 hours of wearing a Sensor During the first 12 hours of wearing a Sensor, you should not use glucose readings from the Sensor to make treatment decisions . You will see the symbol displayed during this time, and whenever you see the symbol, do a blood glucose test and treat based on that result . Think Your Readings are Incorrect?

Dont trust Sensor glucose readings that you think may be incorrect or that dont match what you would expect based on your recent activity . For example, if you ate dinner but forgot to take insulin before eating, you would expect your glucose to be high . If your glucose reading is low, then it doesnt match your recent activity, so dont use it to make treatment decisions . Dont make treatment decisions if you think your Sensor glucose readings are incorrect . Do a blood glucose test and treat based on that result . 37 DOC40395_rev-A_manual.indd 37-38 You Have Low or High Blood Glucose Symptoms Dont ignore symptoms that may be due to low or high blood glucose . Do a blood glucose test and treat based on that result . Symptoms Dont Match Readings There may be times when your symptoms dont match your Sensor glucose readings . For example, you are feeling shaky, sweaty, and dizzy symptoms you generally get when you have low glucose, but your glucose reading is within your target range . When symptoms dont match readings, do a blood glucose test and treat based on that result . Dont ignore symptoms that may be due to low or high blood glucose . If youre the caregiver, pay attention to times when the symptoms of the one youre caring for dont match their Sensor glucose readings . When symptoms dont match readings, do a blood glucose test and treat based on that result . Note: The When to do Nothing and Scan Again Later Your health care professional can help you understand when doing nothing and scanning again later is the right treatment decision . For example, if your glucose is high and going up, your first instinct may be to take more insulin to lower your glucose, however depending on when you last took insulin or your recent activity, the right treatment decision may be to do nothing and scan again later . Dont take a correction dose within 2 hours of your meal dose . This may result in insulin stacking and low glucose . symbol will NOT display in these situations . 38 10/23/18 1:16 PM Making Treatment Decisions Advanced After you scan your Sensor, use all of the information on the screen when deciding what to do or what treatment decision to make. Check Blood Glucose When you see this symbol, do a blood glucose test before making a treatment decision Current Glucose Message Glucose Going Low 82 mg dL Glucose Trend Arrow 350 250 150 50 Glucose Trend Arrow Direction your glucose is going Arrow What it means Glucose rising quickly Glucose rising Glucose changing slowly Glucose falling Glucose falling quickly Glucose Graph Graph of your current and stored glucose readings Food Note mg/dL 350 Rapid-Acting Insulin Note Current Glucose 250 150 50 2pm 6pm 10pm Time 2pm 6pm 10pm Glucose Graph Target Glucose Range 39 DOC40395_rev-A_manual.indd 39-40 This table provides some information on how you can factor the Glucose Trend Arrow into your treatment decisions . Remember that you should never make a treatment decision based on the Glucose Trend Arrow alone . Glucose Trend Arrow Treatment Decision Considerations Low Glucose

(< 70 mg/dL) Glucose in Target Range High Glucose

(> 240 mg/dL) No Arrow or No Number You will see the symbol . Do not treat based on Sensor glucose reading . Do a blood glucose test . You will see the symbol . Do not treat based on Sensor glucose reading . Do a blood glucose test . You will see the symbol . Do not treat based on Sensor glucose reading . Do a blood glucose test . If you are about to eat, take insulin to cover your meal . Consider taking a little more since glucose is rising . If you have taken insulin recently, do nothing and scan again later . Avoid insulin stacking . If you are about to eat, take insulin to cover your meal . Consider taking a little more since glucose is high and rising . If this is between meals, consider taking an insulin correction dose, unless you have taken insulin recently . If you have taken insulin recently, do nothing and scan again later . Avoid insulin stacking . 40 10/23/18 1:16 PM Glucose Trend Arrow Treatment Decision Considerations Low Glucose

(< 70 mg/dL) Glucose in Target Range High Glucose

(> 240 mg/dL) Glucose Trend Arrow Treatment Decision Considerations Low Glucose

(< 70 mg/dL) Glucose in Target Range High Glucose

(> 240 mg/dL) You will see the symbol . Do not treat based on Sensor glucose reading . Do a blood glucose test . If you are about to eat, take insulin to cover your meal . If this is between meals, do nothing and scan again later . If you are about to eat, take insulin to cover your meal . Consider taking a little more since glucose is high . If this is between meals, consider taking an insulin correction dose, unless you have taken insulin recently . If you have taken insulin recently, do nothing and scan again later . Avoid insulin stacking . You will see the symbol . Do not treat based on Sensor glucose reading . Do a blood glucose test . If you are about to eat, take insulin to cover your meal . Consider taking a little less since glucose is falling . If this is between meals, consider eating a snack or fast-acting carbohydrates to stay within target and scan again later . If you are about to eat, take insulin to cover your meal . Consider taking a little less since glucose is falling . If this is between meals, consider doing nothing and scan again later . Avoid insulin stacking . 41 DOC40395_rev-A_manual.indd 41-42 You will see the Do a blood glucose test . symbol . Do not treat based on Sensor glucose reading . 42 10/23/18 1:16 PM Example Scenarios Next are some example scenarios to help you understand how to use the information on your screen . Always use all of the information on the screen before deciding what to do or what treatment decision to make . If you are not sure about what to do, consult your health care professional . What you see When you wake-up:

Low Glucose 65 mg dL 350 250 150 50 9pm 1am 5am What it means When you wake up, your current glucose is 65 mg/dL and the trend arrow shows

. There is also a it is changing slowly Low Glucose and the message at the top of the screen symbol . symbol, you should Anytime you see the do a blood glucose test before deciding what to do . 43 DOC40395_rev-A_manual.indd 43-44 What you see Before breakfast:

8:06am Ends in 2 days 115 mg dL 350 250 150 50 12am 4am 8am After breakfast:

Glucose Going Low 108 mg dL 350 250 150 50 1am 5am 9am What it means Before breakfast, your current glucose is 115 mg/dL . The graph shows that your glucose is going up and so does the trend arrow

. Consider what might be causing your glucose to go up and what you might do to prevent a high glucose . For example:

How much insulin should you take before your meal?

Since you see

, should you consider taking a little more insulin?

After breakfast, your current glucose is 108 mg/dL . The trend arrow shows it is

. There is also a going down quickly Glucose Going Low and the message at the top of the screen symbol . symbol, you should Anytime you see the do a blood glucose test before deciding what to do . 44 10/23/18 1:16 PM What it means When you checked your glucose before lunch, it was 90 mg/dL and rising . Before eating lunch, you took enough insulin to cover the meal and a little more since your trend arrow was

. 90 minutes later, your current glucose is 225 mg/dL . The graph shows that your glucose is still going up, and so does the trend arrow

. Dont take a correction dose within 2 hours of your meal dose. This may result in insulin stacking and low glucose . Consider what might be causing your glucose to go up and what you might do to prevent a high glucose . For example:

Has the insulin you took for your meal reached its full effect?

Scan your Sensor again later . What you see Before lunch:

12:00pm Ends in 3 days dL90 mg 350 250 150 50 4am 8am 12pm After lunch:

1:30pm Ends in 3 days 225 mg dL 350 250 150 50 5am 9am 1pm 45 DOC40395_rev-A_manual.indd 45-46 What you see After exercising:

5:47pm Ends in 9 days 204 mg dL 350 What it means After exercising, you are feeling shaky, sweaty, and dizzy symptoms you generally get when you have low glucose . But, your current glucose is 204 mg/dL . 250 150 50 9am 1pm 5pm Anytime you get a reading that doesnt match how you feel, do a blood glucose test . Before dinner:

7:34pm Ends in 7 days 134 mg dL 350 250 150 50 11am 3pm 7pm Note: The Check Blood Glucose NOT appear in this situation . symbol will Before dinner, your current glucose is 134 mg/dL . The graph shows that your glucose

. is going down and so does the trend arrow Consider what might be causing your glucose to go down and what you might do to prevent a low glucose . For example:

How much insulin should you take before your meal?

Since you see

, should you consider taking a little less insulin?

46 10/23/18 1:16 PM What you see After dinner:

7:49pm Ends in 10 days 215 mg dL 350 250 150 50 11am 3pm 7pm What it means After dinner, your current glucose is 215 mg/dL but there is no trend arrow . There is also the symbol on the screen . symbol, you should Anytime you see the do a blood glucose test before deciding what to do . Other considerations Deciding how much rapid-acting insulin to take for different meals and situations can be difficult . Work with your health care professional to discuss different situations and what might work best for you . Here are some questions to consider:

Meal dosing What do you do if your before meal glucose is high?

What do you do if your before meal glucose is low?

How much time do you wait to eat after taking your meal insulin?

Do you adjust the amount of meal insulin based on the number of carbs or how much you are planning to eat?

Do you adjust your meal insulin dose for high fat foods such as pizza?

Do you know how to adjust your insulin doses when drinking alcoholic beverages?

High glucose corrections Do you take extra insulin if your glucose is high?

How do you decide how much insulin to take for a high glucose?

How long do you wait between insulin doses to avoid insulin stacking?

47 DOC40395_rev-A_manual.indd 47-48 48 10/23/18 1:16 PM Bedtime How often do you check your glucose before bed?

What do you consider a safe bedtime glucose?

What do you do if your bedtime glucose is high?

What do you do if your bedtime glucose is low?

When should you eat a bedtime snack?

What do you do if your before meal glucose is high?

What do you do if your before meal glucose is low?

Other factors How do you adjust your insulin dose based on the Glucose Trend Arrow?

How do you adjust your insulin dose for different types of exercise or activities?

How do you adjust your insulin doses for stress?

How do you adjust your insulin doses for illness?

Alarms When in range of the Reader, your Sensor automatically communicates with the Reader to give you Low and High Glucose Alarms . These alarms are on by default . This section explains how to set and use alarms as well as how to turn them off . Please read all the information in this section before setting and using alarms . CAUTION:

For you to receive alarms, they must be on and your Reader should be within 20 feet of you at all times . The transmission range is 20 feet unobstructed . If you are out of range, you may not receive glucose alarms . To prevent missed alarms, make sure the Reader has sufficient charge and that sound and/or vibration are turned on . 49 DOC40395_rev-A_manual.indd 49-50 50 10/23/18 1:16 PM IMPORTANT: What 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 . The Low and High Glucose Alarms should not be used exclusively to detect low or high glucose conditions . The glucose alarms should always be used along with your current glucose, glucose trend arrow, and glucose graph . Low and High Glucose Alarm levels are different from your Target Glucose Range values . Low and High Glucose Alarms tell you when your glucose has passed the level you set in the alarm . Your Target Glucose Range is displayed on glucose graphs on the Reader and used to calculate your Time In Target . IMPORTANT: How to prevent missed alarms Alarms must be kept on for you to receive them and you should ensure that your Reader is within 20 feet of you at all times . The Sensor itself will not issue alarms . If the Sensor is not communicating with the Reader, you will not receive glucose alarms, and you may miss detecting low glucose or high glucose episodes . You will see the on the Home screen when the Sensor is not communicating with the Reader . Make sure the Signal Loss Alarm is on so you will be notified if your Sensor has not communicated with the Reader for 20 minutes . symbol Make sure the Readers sound and/or vibration settings are on and your Reader is near you . The Home screen indicates the sound/vibration setting when any alarm is on:

Sound and Vibration ON Sound ON, Vibration OFF Sound OFF, Vibration ON Sound and Vibration OFF 51 DOC40395_rev-A_manual.indd 51-52 52 10/23/18 1:16 PM Setting Alarms Work with your health care professional to determine your alarm settings . Step 1 Action 10:23pm Ends in 14 days From the Home screen, touch the Settings symbol

. Touch Alarms . Step 3 Change Alarm Settings OK Low Glucose Alarm High Glucose Alarm Signal Loss Alarm Check Glucose Review Settings History Alarms Sound & Vibration Time & Date 1 / 4 2 Alarm Settings OK Touch Change Alarm Settings . Low Glucose 70 mg/dL High Glucose 240 mg/dL Signal Loss On Change Alarm Settings 53 DOC40395_rev-A_manual.indd 53-54 Alarm Low Glucose Alarm Action Select the alarm you want to set or turn off . Low Glucose Alarm: Notifies you when your glucose is below the level you set . High Glucose Alarm: Notifies you when your glucose is above the level you set . Signal Loss Alarm: Notifies you when your Sensor is not communicating with the Reader and that you will not receive Low or High Glucose Alarms . How to Set Low Glucose Alarm

The Low Glucose Alarm is on by default . The alarm level is initially set to 70 mg/dL . You can use the arrows to change this value between 60 mg/dL and 100 mg/dL . If the alarm is on, you will be notified when your glucose falls below the level you set . Touch the slider to turn the alarm off . Touch done to save . 70 mg/dL On done 54 10/23/18 1:16 PM Alarm High Glucose Alarm Step 4

How to Set The High Glucose Alarm is on by default . The alarm level is initially set to 240 mg/dL . You can use the arrows to change this value between 120 mg/dL and 400 mg/dL . If the alarm is on, you will be notified when your glucose rises above the level you set . Touch the slider to turn the alarm off . High Glucose Alarm 240 mg/dL On done Action When you are finished setting your alarms, touch OK . The Alarms Settings screen now shows your current alarm settings . Touch OK to return to the main settings menu, or touch Change Alarm Settings to make additional updates . Change Alarm Settings OK Low Glucose Alarm High Glucose Alarm Signal Loss Alarm Alarm Settings OK Low Glucose 70 mg/dL High Glucose 240 mg/dL Signal Loss On Change Alarm Settings Touch done to save . Signal Loss Alarm If the alarm is on, you will be notified when your Sensor has not communicated with your Reader for 20 minutes and you are not receiving Low or High Glucose Alarms . Touch the slider to turn the alarm off . Signal Loss Alarm On Turn On to get notified when the glucose alarms you set are not available because your Sensor is not communicating with the Reader. done Touch done to save . 55 DOC40395_rev-A_manual.indd 55-56 56 10/23/18 1:16 PM Setting Alarm Sounds Step 1 2 Action From the Home screen, touch the Settings symbol Vibration to change the alarm sounds . Touch Sound &

10:23pm Ends in 14 days Check Glucose Review Settings History Alarms Sound & Vibration Time & Date 1 / 4 Sound & Vibration OK System Sounds On Volume High Vibration Touch Sounds Off Off Touch the sound or vibration setting you would like to change . Note: These settings apply to the alarms as well as other Reader functions . Touch OK to save . Using Alarms What you See Low Glucose Alarm Dismiss Alarm & Check Glucose What it Means The Low Glucose Alarm notifies you if your 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 . Touch Dismiss Alarm & Check Glucose or press the Home Button to dismiss the alarm and check your glucose . You will only receive one alarm per low glucose episode . High Glucose Alarm Dismiss Alarm & Check Glucose The High Glucose Alarm notifies you if your glucose rises above the level you set . The alarm does not include your glucose reading, so you need to scan your Sensor to check your glucose . Touch Dismiss Alarm & Check Glucose or press the Home Button to dismiss the alarm and check your glucose . You will only receive one alarm per high glucose episode . 57 DOC40395_rev-A_manual.indd 57-58 58 10/23/18 1:16 PM What you See What it Means Adding Notes Signal Loss Alarm Scan Sensor now?

No Yes The Signal Loss Alarm notifies you if your Sensor has not communicated with the Reader for 20 minutes and you are not receiving Low or High Glucose Alarms . Signal loss could be caused by the Sensor being too far away from the Reader

(over 20 feet) or another issue such as an error or problem with your Sensor or Reader . Touch No to dismiss the alarm . Touch Yes or press the Home Button to dismiss the alarm and scan the Sensor . Notes:

If you ignore an alarm, you will receive it again in 5 minutes if the condition still exists . If you receive an alarm while the Reader is connected to a computer, you must first unplug the Reader to scan the Sensor . 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 . Step 1 Action Glucose Going High 236 mg dL 350 250 150 50 6am 10am 2pm symbol in the upper right From the Glucose Reading screen, add notes by touching the corner of the touchscreen . If you do not want to add notes, you can press the Home Button to go to the Home Screen or hold the Home Button to turn the Reader off . 2 Add Notes OK Rapid-Acting Insulin Long-Acting Insulin Food 1 / 4 Select the checkbox next to the notes you would like to add . Touch the down arrow to view other note options . 59 DOC40395_rev-A_manual.indd 59-60 60 10/23/18 1:16 PM Action Reviewing Your History Step 3 Add Notes OK Rapid-Acting Insulin Long-Acting Insulin Food

Enter Rapid-Acting Insulin OK 1 / 4 units 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 Food notes: Enter grams or serving units taken . information . Note: Food and rapid-acting insulin on your glucose graphs and in your Logbook as symbols . notes are shown 4 Add Notes OK Touch OK to save your notes . Rapid-Acting Insulin Long-Acting Insulin Food

1 / 4 You can review your notes from the Logbook . See Reviewing Your History section for more information . 61 DOC40395_rev-A_manual.indd 61-62 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 1 Action Check Glucose Scan Sensor to check glucose. Press the Home Button to turn on the Reader . Press the Home Button again to go to the Home Screen . 2 10:23pm Ends in 14 days Check Glucose Review History Touch the Review History icon . 62 10/23/18 1:16 PM Step 3 Action Review History Use the arrows to view the available options . Logbook Daily Graph Average Glucose Daily Patterns Time In Target 1 / 2 Low Glucose Events Sensor Usage IMPORTANT: Work with your health care professional to understand your glucose history . The Logbook and Daily Graph show detailed information, while other history options show summaries of information over a number of days . Logbook Logbook OK 23 Feb 10:23am 143 23 Feb 6:37am 98 22 Feb 11:09pm 108 mg/dL Entries for each time you scanned your Sensor or performed a blood glucose test . If you entered Notes with a glucose reading, the symbol appears in that row . For more 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 . 63 DOC40395_rev-A_manual.indd 63-64 64 10/23/18 1:16 PM Daily Graph Daily Graph

(mg/dL) OK 350 250 150 50 12 am 6 am 12 pm 6 pm 12 am 22 Feb Wednesday 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 . Notes:

While Sensor glucose readings are gathered in the System range of 40-500 mg/dL, the Daily Graph display range is 0-350 mg/dL for ease of review on screen . Glucose readings above 350 mg/dL are displayed at 350 mg/dL . For sequential readings above 350 mg/dL, a line is 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 . Other History Options Use the arrows to view information about your last 7, 14, 30, or 90 days . Average Glucose OK Average: 119 mg/dL 152 134 121 69 6 12 am am 6 12 pm pm 12 am Last 7 Days Average Glucose Daily Patterns

(mg/dL) OK 350 250 150 50 12 am 6 am 12 pm 6 pm 12 am Last 7 Days Daily Patterns Information about the average of your Sensor glucose readings . The overall average for the time is displayed above the graph . The average is also shown for four different 6-hour periods of the day . Readings above or below your Target Glucose Range are orange, while readings in range are blue . 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

(10-90 percentiles) of your Sensor readings . Note: Daily Patterns needs at least 5 days of glucose data . 65 DOC40395_rev-A_manual.indd 65-66 66 10/23/18 1:16 PM A graph showing the percentage of time your Sensor glucose readings were above, below, or within your Target Glucose Range . 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 15 minutes or longer . The total number of events is displayed above the graph . The bar graph displays the low glucose events in four different 6-hour periods of the day . Information about how often you scan your Sensor . The Reader reports an average of how many times you scanned your Sensor each day, and the percentage of possible Sensor data the Reader recorded from your scans . Time In Target OK Above 34%

In Target 54%

Below 12%

Target Range 80-140 mg/dL Last 7 Days Time In Target OK Low Glucose Events Total Events: 10 6 3 1 0 6 12 am am 6 12 pm pm 12 am Last 7 Days Low Glucose Events Sensor Usage OK Scans Per Day 5 Sensor Data Captured 100%

Last 7 Days Sensor Usage 67 DOC40395_rev-A_manual.indd 67-68 Removing Your Sensor Step 1 2 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 . Discard the used Sensor following directions from your health care professional . 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 it ended, you will be prompted to confirm that you would like to start a new Sensor when you first scan it . 68 10/23/18 1:16 PM Replacing Your Sensor Using Reminders 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 Sensor is becoming loose or if the Sensor tip is coming out of your skin, you may get no readings or unreliable readings, which may not match how you feel . Check to make sure your Sensor has not come loose . If it has come loose, remove it and apply a new one . You can use Reminders to help you remember things like checking your glucose or taking insulin . Step 1 Action 10:23pm Ends in 14 days From the Home Screen, touch the Settings symbol

. Scroll down using the arrow and touch Reminders . Check Glucose Review History Reminders Control Solution Test Language 2 / 4 2 Set Reminder Type Other Repeat Daily Time XX:XX cancel save Touch to select which Type of reminder you want to set: Check Glucose, Take Insulin, or Other, which is a general reminder to help you remember something . 69 DOC40395_rev-A_manual.indd 69-70 70 10/23/18 1:16 PM Action Using the Readers Built-in Meter Step 3 4 5 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 . Touch save . From the Reminders screen, you can turn the reminder On/Off or add new reminders . Touch done to return to the Home Screen . Reminders 8:30am On 12:30pm Off 00:00:00 On add new done Reminder 8:30am snooze 15 min OK You will get your reminder 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 . 71 DOC40395_rev-A_manual.indd 71-72 The Reader has a built-in meter that can be used to test your blood glucose, 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 due to the potential risk of electrical shock . Intended Use The FreeStyle Libre 2 Readers built-in meter is for use outside the body only (in vitro diagnostic use) in the quantitative measurement of glucose in fresh whole blood for self testing by lay users from the fingers . It is not intended to be used for testing neonatal blood samples or for the diagnosis or screening of diabetes . The FreeStyle Libre 2 Readers built-in meter is indicated for the home (lay) user in the management of patients with diabetes . It is intended to be used by a single person and should not be shared . The FreeStyle Precision Neo Blood Glucose Test Strips are for use with the FreeStyle Libre 2 Readers built-in meter to quantitatively measure glucose

(sugar) in fresh capillary whole blood samples drawn from the fingertips . 72 10/23/18 1:16 PM IMPORTANT:

Use only FreeStyle Precision Neo test strips . Other test strips may produce inaccurate results . Read all the instructions in this section . Failure to follow instructions may cause incorrect blood glucose results . Practice the testing procedures before using the Readers built-in meter . Read the test strip instructions for use before performing your first blood glucose test as they contain important information . They also let you know how to store and handle the test strips and give you information about sample types . The Readers built-in meter is not for use on people who are dehydrated, hypotensive, in shock, or for individuals in hyperglycemic-hyperosmolar state, with or without ketosis . The Readers built-in meter is not for use on neonates, in critically-ill patients, or for diagnosis or screening of diabetes . Follow your health care professionals advice when testing blood glucose levels . Observe caution when using around children . Small parts may constitute a choking hazard . You should clean and disinfect the Reader once per week . The Reader should also be cleaned and disinfected prior to being handled by any person providing testing assistance to the user . IMPORTANT: (cont.) 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 and disinfection procedure .1, 2 Use the Readers built-in meter within the test strip operating temperature range or you will see Error Message E-1 . Use a test strip immediately after removing from its foil packet . Only use a test strip once . Do not put urine on the test strip . 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 . 73 DOC40395_rev-A_manual.indd 73-74 74 10/23/18 1:16 PM Blood Glucose Testing You can use the built-in meter to check your blood glucose, whether you are wearing a Sensor or not . Be sure to read the test strip instructions for use prior to using the built-in meter . Step 1 Action CAUTION: Test on your fingers in accordance with the Intended Use in this section . 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: Do not use lotion or cream on the test site . Avoid moles, veins, bones, and tendons . Bruising may occur at the test site . If you get a bruise, consider selecting another site . Step 2 3 4 Action Check the test strip expiration date . Do not use expired test strips as they may give inaccurate results . d t L e r a C s e t e b a D i t t o b b A d a o R e g n a R L Y 0 9 2 X O

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. K U n i e d a M 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 . Insert the test strip with the three black lines at the end facing up . Push the strip in until it stops . Note: The Readers built-in meter turns off after 2 minutes of inactivity . Remove and reinsert the unused test strip to restart the built-in meter . 75 DOC40395_rev-A_manual.indd 75-76 76 10/23/18 1:16 PM Step 5 Apply Blood Action Use your lancing device to obtain a blood drop and apply blood to the white area at the end of the test strip . Refer to your lancing device instructions for use if you need help using your lancing device . If sounds are turned on, the Reader beeps once to let you know you have applied enough blood . You will see a butterfly on the screen while you wait for your result . Do not remove the test strip while the butterfly is on the screen . If sounds are turned on, the Reader beeps once when your result is ready . If the butterfly does not appear, you may not have applied enough blood to the test strip . Apply a second drop of blood to the test strip within 5 seconds of the first drop . If the butterfly still does not appear or if more than 5 seconds have passed, discard the test strip . Turn off the Reader and repeat the steps in this section with a new test strip . 77 DOC40395_rev-A_manual.indd 77-78 Step 5

(cont.) Action Note:

E-3 means the blood drop is too small, or incorrect test procedure, or there may be a problem with the test strip . E-4 means the blood glucose level may be too high to be read by the system or there may be a problem with the test strip . See Troubleshooting section for more information . 6 After reviewing your result, remove and discard the used test strip according to local regulations . IMPORTANT: After performing a blood glucose test, wash your hands with soap and water and thoroughly dry them . 10:23pm 143 mg dL Example Screen Only Your Blood Glucose Results Blood glucose results are marked on the results screen and in the Logbook with the symbol . Note: Contact your health care professional if you have symptoms that do not match your test results . 78 10/23/18 1:16 PM IMPORTANT: The built-in meter displays results from 20 - 500 mg/dL . Low or high blood glucose results can indicate a potentially serious medical condition . The expected glucose range for a non-diabetic, non-pregnant fasting adult is under 100 mg/dL . Two hours after meals, levels should be less than 140 mg/dL .3 Consult your healthcare professional to determine the range that is appropriate for you . Display Low Glucose LO mg dL High Glucose HI mg dL What To Do 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 . Display Low Glucose 63 mg dL High Glucose 289 mg dL What To Do 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 . 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 the to go to the Home Screen or hold the Home Button to turn the Reader off . IMPORTANT: You should clean and disinfect your Reader once per week . Refer to the Maintenance and Disposal section for instructions . 79 DOC40395_rev-A_manual.indd 79-80 80 10/23/18 1:16 PM 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 Readers built-in meter and test strips are working properly . 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 or on the expiration date printed on the bottle, whichever comes first . (Example: open April 15, discard July 15; write the discard date on the side of the bottle .) . The control solution range is a target range for control solution only, not for your blood glucose results . The control solution test does not reflect your blood glucose level . Use only MediSense (low, medium or high) Glucose and Ketone Control Solution with the Readers built-in meter . 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 (1-855-632-8658) for information on how to obtain control solution . 81 DOC40395_rev-A_manual.indd 81-82 Step 1 10:23pm Ends in 14 days Check Glucose Review History Action From the Home Screen, touch the Settings symbol touch Control Solution Test . Scroll down using the arrow and 2 3 Reminders Control Solution Test Language 2 / 4 Check the test strip expiration date . d t L e r a C s e t e b a D i t t o b b A d a o R e g n a R L Y 0 9 2 X O

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. K U n i e d a M Open the foil test strip packet at the notch and tear down to remove the test strip . 82 10/23/18 1:16 PM Step 4 Action Insert the test strip with the three black lines facing up . Push the strip until it stops . Note: The Readers built-in meter turns off after 2 minutes of inactivity . Remove and reinsert the unused test strip to restart the built-in meter . Step 5

(cont.) 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 . Action You will see a butterfly on the screen while you wait for the result . Do not remove the test strip while the butterfly is on the screen . If sounds are turned on, the Reader beeps once when the result is ready . If the butterfly does not appear, you may not have applied enough control solution to the test strip . Apply a second drop of control solution to the test strip within 5 seconds of the first drop . If the butterfly still does not appear or if more than 5 seconds have passed, discard the test strip . Turn off the Reader and repeat the steps in this section with a new test strip . 83 DOC40395_rev-A_manual.indd 83-84 84 10/23/18 1:16 PM 10:23pm 100 mg dL Control Solution Test Example Screen Only 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 . 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 of use . Low Battery OK Please charge the Reader to continue using it. 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 . Dont block access to the charger due to the potential risk of electrical shock . Notes:

You must charge the Reader when the battery to keep using the Reader . To fully charge the battery, charge the Reader Only use the USB cable and power adapter Fully charge your Reader before storing it for included with the system . for at least 3 hours . is low more than 3 months . 85 DOC40395_rev-A_manual.indd 85-86 86 10/23/18 1:16 PM 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 target range . The Settings menu is also where you go to do a Control Solution Test or to check the System Status . Step 1 Action 10:23pm Ends in 14 days To get to the Settings menu, touch the Settings symbol on the Home Screen . Step 2 Check Glucose Review History Settings Alarms Sound & Vibration Time & Date 1 / 4 87 DOC40395_rev-A_manual.indd 87-88 Action 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 See Using Reminders section for information on setting reminders Control Solution Test Perform a control solution test Language Change the language on the Reader 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 and status codes 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 88 10/23/18 1:16 PM Action Living With Your System Step 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 and vibrations are working, and the Touchscreen is responding when touched Report Settings Work with your health care professional to set your Target Glucose Range, which is displayed on glucose graphs on the Reader and used to calculate your Time In Target . Your Target Glucose Range is not related to your alarm settings Reader Basics Review the information screens shown during the Reader setup Dose Increment You can set the insulin dose increment to either 1 .0 or 0 .5 units for use with insulin notes 89 DOC40395_rev-A_manual.indd 89-90 Your System can be used during a wide variety of activities . Activity What You Need To Know Bathing, Showering, and Swimming Sleeping 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 3 feet (1 meter) or immerse it longer than 30 minutes in water . 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 only 8 hours of data at a time . For example, if you sleep for 9 hours without scanning your Sensor, 1 hour of data will not be collected and a gap will appear on your glucose graph . If you want to receive alarms or reminders while you are sleeping, place the Reader nearby . You should also make sure sound and/or vibration is turned on . 90 10/23/18 1:16 PM Activity What You Need To Know Activity What You Need To Know Traveling by Air You may safely use your System at all times while on an aircraft, following any requests from the flight crew . The Reader is classed as a Medical-Portable Electronic Device (M-PED) that meets all required M-PED emission standards for safe use onboard an aircraft: RTCA/DO160, Section 21, Category M . Some airport full-body scanners include x-ray or millimeter radio-wave, which you cannot expose your System to . The effect of these scanners has not been evaluated and the exposure may damage the System or cause inaccurate results . To avoid removing your System, you may request another type of screening . If you do choose to go through a full-body scanner, you must remove your Sensor . Traveling by Air

(cont.) The System can be exposed to common electrostatic (ESD) and electromagnetic interference (EMI), including airport metal detectors . You can keep your Reader on while going through these . 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 and statistics . The graph indicating the Reader time was changed . Gaps in the graph may result or glucose readings may be hidden . symbol may appear on your glucose 91 DOC40395_rev-A_manual.indd 91-92 92 10/23/18 1:16 PM This device is not intended for use in healthcare or assisted-use settings such as hospitals, physician offices, or long-term care facilities because it has not been cleared by FDA for use in these settings, including for routine assisted testing or as part of glycemic control procedures . Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus

(HBV), or other bloodborne pathogens . Maintenance and Disposal Cleaning and Disinfecting the Reader Cleaning and disinfecting your Reader is important to prevent the spread of infectious diseases . The Reader has a mean use life of 3 years and has been validated for 156 cleaning and disinfection cycles (the equivalent of 1 cycle per week for 3 years) . You should clean and disinfect the Reader once a week . The Reader should also be cleaned and disinfected prior to being handled by any person providing testing assistance to the user . Cleaning is the physical removal of organic soil from the Reader surfaces . Keeping the Reader clean helps ensure that it is working properly and that no dirt gets in the device . Cleaning allows for successful, subsequent disinfection . Disinfection is a process that destroys pathogens, such as viruses and other microorganisms, on the Reader surfaces . Disinfecting the Reader helps ensure that no infection is passed on when you or others come in contact with the Reader . 93 DOC40395_rev-A_manual.indd 93-94 94 10/23/18 1:16 PM To clean and disinfect your Reader, you will need Clorox Healthcare Bleach Germicidal Wipes, EPA Reg . #67619-12 . These disinfectant wipes contain a 0 .55% Sodium Hypochlorite (NaOCl) solution and have been shown to be safe for use with the Reader . They may be purchased at major online retailers, such as Walmart .com, Amazon .com, and OfficeDepot .com . Note: Additional information about the risks for transmitting bloodborne pathogens to persons undergoing fingerstick procedures for blood sampling can be found . See References section for more information . Step 1 Turn off the Reader before you clean and disinfect it . Action 2 Clean the outside surfaces of the Reader with a bleach wipe until visibly clean . Make sure liquid does not get into the test strip and USB ports . Step 3 4 5 Action For disinfection, use a second bleach wipe to wipe all outside surfaces of the Reader until they are wet . Make sure liquid does not get into the test strip and USB ports . Allow the Reader surfaces to remain wet for 60 seconds . Dry with clean paper towel to remove any residual moisture . When finished, thoroughly wash your hands with soap and water . 95 DOC40395_rev-A_manual.indd 95-96 96 10/23/18 1:16 PM IMPORTANT: If you require assistance or if you notice any signs of deterioration on the Reader (such as clouding or crazing on the display of the Reader, corroding or eroding of the plastic housing, or cracking of plastic housing or display) or if the Reader does not turn on, discontinue use of the Reader and contact Customer Service at 1-855-632-8658 . CAUTION: Do NOT place the Reader in water or other liquids . Avoid getting dust, dirt, blood, control solution, water, bleach, or any other substance in the test strip or USB ports as this may cause the Reader to not function properly . Maintenance The 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 . 97 DOC40395_rev-A_manual.indd 97-98 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 Reader battery is too low . Charge the Reader . Reader does not power on after you press the Home Button or insert a test strip . Reader is outside of its operating temperature range . Move the Reader to a temperature between 50 F and 113 F and then try to power it on . If the Reader still does not power on after trying these steps, contact Customer Service . 98 10/23/18 1:16 PM Problems at the Sensor Application Site 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 . 99 DOC40395_rev-A_manual.indd 99-100 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 1 .5 inches (4 cm) of the Sensor . Bring the screen of the Reader close to the Sensor . Sensor Ended The Sensor life has Apply and start a new Sensor . ended . 100 10/23/18 1:16 PM Display What It May Mean What To Do Display What It May Mean What To Do Signal Loss Alarm Sensor has not automatically communicated with the Reader in the last 20 minutes . New Sensor Found You scanned a new Sensor before your previous Sensor ended . Make sure the Reader is within 20 feet of the Sensor . Try scanning the Sensor to get a glucose reading . If the Signal Loss Alarm shows again after scanning your Sensor, contact Customer Service . 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 . 101 DOC40395_rev-A_manual.indd 101-102 Sensor Error The System is unable to provide a glucose reading . Scan again after the duration specified in the message . Note: If you receive this error during your first 12 hours of wearing a Sensor, it may mean that your body is still adjusting to the Sensor . Use a blood glucose meter to check your glucose while you wait . You do not need to remove your Sensor . 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 . 102 10/23/18 1:16 PM Display What It May Mean What To Do Problems Receiving Glucose Alarms Sensor Already in Use The Sensor was started by another device . Your Reader can only be used with a Sensor that it started . Scan the Sensor again with the device 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 . 103 DOC40395_rev-A_manual.indd 103-104 Problem What It May Mean What To Do You are not receiving glucose alarms . You have not turned alarms on . Touch the Settings symbol and then select Alarms . The Sensor is not communicating with your Reader . or There may be a problem with your Sensor or Reader . The Sensor must be within range

(20 feet) of the Reader for you to receive alarms . Make sure that you are within this range . You will see the symbol at the top of the Home screen when your Sensor is not communicating with the Reader . If the Signal Loss Alarm is on, you will be notified if there has been no communication for 20 minutes . Try scanning your Sensor . If the Signal Loss Alarm is on and shows again after scanning your Sensor, contact Customer Service . Sound/vibration are turned off . Check the Readers sound and vibration settings to confirm sound/vibration are on . 104 10/23/18 1:16 PM Problem What It May Mean What To Do Blood Glucose Error Messages You are not receiving glucose alarms .

(cont.) You may have set an alarm level that is higher or lower than you intended . Confirm your alarm settings are appropriate . Error Message E-1 You have already dismissed this type of alarm . You will receive another alarm when a new low or high glucose episode starts . The temperature is too hot or too cold for the Reader to work correctly . What It May Mean What To Do Your Sensor has ended . Replace your Sensor with a new one . Your Reader battery is dead . Charge your Reader with the included USB cable . E-2 Reader error . 105 DOC40395_rev-A_manual.indd 105-106 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 . 1 . Turn off the Reader . 2 . Repeat the test using a new test strip . 3 . If the error reappears, contact Customer Service . 106 10/23/18 1:16 PM Error Message E-3 E-4 What It May Mean What To Do 1 . Review the testing instructions . 2 . Repeat the test using a new test strip . 3 . If the error reappears, contact Customer Service . 1 . Repeat the test using a new test strip . 2 . If the error reappears, contact your health care professional immediately . Blood drop is too small . or Incorrect test procedure . or There may be a problem with the test strip . The blood glucose level may be too high to be read by the system . or There may be a problem with the test strip . Error Message E-5 What It May Mean What To Do 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 . 107 DOC40395_rev-A_manual.indd 107-108 108 10/23/18 1:16 PM What It May Mean What To Do Error Message 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 . 1 . Turn off the Reader . 2 . Repeat the test using a new test strip . 3 . If the error reappears, contact Customer Service . E-9 Reader error . 109 DOC40395_rev-A_manual.indd 109-110 Problems Checking Your Blood Glucose 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 . Reader is outside of its operating temperature range . Insert a new FreeStyle Precision Neo test strip . Move the Reader to a temperature between 50 F and 113 F and then try to power it on . 110 10/23/18 1:16 PM Problem What It May Mean What To Do Perform a Reader Test Blood sample is too small . The test does not start after applying the blood sample . Sample applied after the Reader turned off . 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 . 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 . System Status OK System Info Reader Test Event Log from the Home If you think the Reader is not working properly, you can check the Reader by performing a Reader Test . Touch the Settings symbol 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 display, sounds, and touchscreen are working properly . 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 . Customer Service Customer Service is available to answer any questions you may have about your System . Please go to the back cover of this manual for your Customer Service phone number . 111 DOC40395_rev-A_manual.indd 111-112 112 10/23/18 1:16 PM 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 113 DOC40395_rev-A_manual.indd 113-114 Sensor data Up to 14 days Sensor memory Sensor transmission range 8 hours (glucose readings stored every 15 minutes) 20 feet (6 meters) unobstructed Operating temperature 50 F to 113 F Sensor Applicator and Sensor Pack storage temperature Operating and storage relative humidity Sensor water resistance and ingress protection 39 F to 77 F 10-90%, non-condensing IP27: Can withstand immersion into 3 ft (one meter) of water for up to 30 minutes . Protected against insertion of objects > 12mm diameter . Operating and storage altitude

-1,250 ft (-381 meters) to 10,000 ft

(3,048 meters) Radio Frequency 2 .402-2 .480 GHz BLE; GFSK; 0dBm EIRP*

114 10/23/18 1:16 PM Reader Specifications Blood glucose assay range 20 to 500 mg/dL Reader size 95 mm x 60 mm x 16 mm Reader weight 65 grams Reader moisture protection Keep dry Operating and storage altitude

-1,250 ft (-381 meters) to 10,000 ft

(3,048 meters) Reader display timeout 60 seconds (120 seconds when test strip is inserted) Near Field Communication (13 .56 MHz RFID); ASK Modulation; 124 dBuV/m;

1 .5 inch communication range 2 .402-2 .480 GHz BLE; GFSK; 2dBm EIRP*

Reader power source One lithium-ion rechargeable battery Radio Frequency Reader battery life 4 days of typical use Reader memory 90 days of typical use Reader operating temperature Reader storage temperature 50 F to 113 F

-4 F to 140 F Operating and storage relative humidity 10-90%, non-condensing 115 DOC40395_rev-A_manual.indd 115-116 Data port Micro USB Minimum Computer Requirements System must only be used with EN60950-1 rated computers Mean use life 3 years of typical use Reader cleaning and disinfection The Reader has a mean use life of 3 years, which is 156 cleaning and disinfection cycles (1 cycle per week for 3 years) . 116 10/23/18 1:16 PM Power Adapter USB Cable Abbott Diabetes Care PRT25611 Operating temperature: 50 F to 104 F Abbott Diabetes Care PRT21373 Length: 37 inches (94 cm)

* Security measures: The communication between the Reader and Sensor during a scan is a short range Near Field Communication (NFC) method which makes it difficult to interfere with or intercept during transmission. The transmitted data is protected by a proprietary data format, encryption, and memory map. The integrity of transmitted data is ensured by a cyclic redundancy check (CRC) generated by the Sensor and verified by the Reader. The communication between the Reader and Sensor for Alarm data is a standard Bluetooth Low Energy (BLE) connection. The pairing of the Sensor to the Reader is accomplished during activation with an authenticated login procedure that uses an Out-of-band key exchange (NFC). This prevents unauthorized devices from connecting to the Sensor. The transmitted data has a range of 20 feet and is protected by a proprietary data format and encryption. This prevents unauthorized devices from accessing the data if they are within range and intercept the transmission. The BLE communication uses a 2 second connection interval. Under normal operation, the industry standard BLE protocols allow for many users to be in the same vicinity. In the case where the connection is lost due to out-of-range or interference, reconnection is only possible with the authenticated Reader that activated the Sensor. Quality of Service (QoS): QoS for the FreeStyle Libre 2 Reader and Sensor wireless communications using NFC is assured within the effective range of 4 cm between the Sensor and Reader that is specified to occur within 15 seconds. QoS for the wireless communication using BLE is assured within the effective range of 20 feet, unobstructed, between the Reader and Sensor at regular 1-minute intervals. If connection is lost between the Reader and Sensor for 5-minutes, the connection lost symbol displays. If connection is lost for 20 minutes, the Reader alarms the user if the alarm is turned on. If connection is lost between the Sensor and the Reader, up to 8 hours of glucose results can be retrieved by performing a scan with the Reader. The Reader is designed to only accept radio frequency (RF) communications from recognized and paired Sensors. 117 DOC40395_rev-A_manual.indd 117-118 Labeling Symbols Consult instructions for use Use-by date Temperature limit Catalog number Manufacturer Serial number Batch code Keep dry Type BF applied part Non-ionizing radiation CODE Sensor code Caution Do not re-use Sterilized using irradiation MR unsafe Humidity limitation FCC Declaration of Conformity mark Contains FCC ID:

N6C-SXSDCAG, IC: 4908B-SXSDCAG Do not use if package is damaged 118 10/23/18 1:16 PM Not made with natural rubber latex CAUTION: Federal law restricts this device to sale by or on the order of a physician . This product contains electronic equipment, batteries, sharps and materials that may contact bodily fluids during use . Dispose of product in accordance with all applicable local regulations . Performance Characteristics Clinical Study Overview Performance of the FreeStyle Libre 2 Flash Glucose Monitoring System (the System) was evaluated in a clinical study. The study was conducted at 4 centers with a total of 95 subjects with diabetes

(84.2% Type 1, 15.8% Type 2). All subjects were aged eighteen and older. Subjects in the study required insulin to manage their diabetes. Each subject wore up to two Sensors on the back of the upper arm. During the study, subjects tested their blood glucose using fingerstick capillary samples at least eight times during each day of the study. Subjects used the blood glucose meter built into the Reader. Additionally, subjects had their venous blood glucose analyzed up to 112 times over four separate visits to the clinical center. Venous blood was analyzed using the Yellow Springs Instrument Life Sciences 2300 STAT Plus Glucose & Lactate Analyzer (YSI). YSI is a laboratory glucose and lactate analyzer of whole blood and plasma and is a widely recognized standard in laboratory analysis of blood glucose. Glucose readings obtained from the System were compared to glucose readings obtained from the YSI to evaluate the performance of the System. Three lots of Sensors were evaluated in the study. Agreement with YSI Levels Agreement between the System Glucose Measurement (CGM) and venous blood was characterized by using paired CGM and Yellow Springs Instrument measurements (YSI). The accuracy of CGM versus YSI reference was assessed by calculating the percentage of System readings that were within 15%, 20%, 30% and 40% for reference values 80 mg/dL and above, and 15 mg/dL, 20 mg/dL, 30 mg/dL and 40 mg/dL for values below 80 mg/dL when glucose levels are assigned using the YSI values. Overall 90.7% of results were within 20 mg/dL / 20% of YSI reference. 119 DOC40395_rev-A_manual.indd 119-120 120 10/23/18 1:16 PM Agreement with CGM Glucose Levels Agreement between CGM and venous blood was characterized by using paired CGM and Yellow Springs Instrument measurements (YSI). The accuracy of CGM versus YSI reference was assessed by calculating the percentage of System readings that were within 15%, 20%, 30% and 40% for reference values 80 mg/dL and above, and 15 mg/dL, 20 mg/dL, 30 mg/dL and 40 mg/dL for values below 80 mg/dL. The results are presented in Table 1 for YSI reference. Overall 90.9% of results were within 20 mg/dL / 20% of YSI reference. Table 1: Number and Percent of Results within YSI Reference CGM Glucose Level

(mg/dL) Number of CGM-Reference Pairs Within 15% /

15mg/dL Within 20% /

20mg/dL Within 30% /

30mg/dL Within 40% /

40mg/dL Outside 40% /

40mg/dL Overall 40-50 51-80 81-180 181-300 301-400 401-500 9725 40 741 6112 2513 291 28 83.0 52.5 58.2 82.2 91.7 89.0 90.9 60.0 70.9 90.9 96.9 95.2 97.3 80.0 87.9 97.5 99.4 99.7 99.1 85.0 94.6 99.4 99.8 99.7 100.0 100.0 100.0 100.0 0.9 15.0 5.4 0.6 0.2 0.3 0.0 121 DOC40395_rev-A_manual.indd 121-122 Agreement on Day 1 against YSI Reference The accuracy of CGM versus YSI reference on the first day of Sensor wear was assessed by calculating the percentage of System readings that were within 15%, 20%, 30% and 40% for reference values 80 mg/dL and above, and within 15 mg/dL, 20 mg/dL, 30 mg/dL and 40 mg/dL for values below 80 mg/dL by hourly intervals. The results are presented in Table 2. Table 2: Number and Percent of Results within YSI Reference Time Interval

(hours) Number of CGM-

Reference Pairs Within 15% /

15mg/dL Within 20% /

20mg/dL Within 30% /

30mg/dL Within 40% /

40mg/dL Outside 40% /

40mg/dL

(0-2] *

(2-4]

(4-6]

(6-8]

(8-16]

(16-18]

(18-20]

(20-22]

(22-24) 182 385 375 373 106 303 344 336 155 77.5 71.2 77.6 78.0 74.5 80.2 80.2 81.3 86.5 87.9 83.1 86.4 87.9 83.0 89.1 86.6 87.8 93.5 95.6 94.8 91.7 97.3 97.2 96.7 94.8 97.9 96.1 99.5 98.4 96.3 99.5 100.0 99.7 98.8 98.8 98.7 0.5 1.6 3.7 0.5 0.0 0.3 1.2 1.2 1.3

* (0-2] interval includes the 1 hour start-up time. Time interval is not divided to smaller segments due to small number of data pairs. 122 10/23/18 1:16 PM Overall Accuracy against YSI reference Accuracy was measured by comparing the absolute relative difference between the System and reference YSI glucose values. The absolute relative difference measures the level of disagreement between the System and the reference value, but does not tell you whether the System glucose value was, on average, higher or lower than the reference glucose value. The Mean Absolute Relative Difference gives an indication of the average percent disagreement between the CGM and the reference. Table 3 shows the overall absolute difference measure. Overall the Mean Absolute Relative Difference was 9.4% for the comparison with YSI reference. The Median Absolute Relative Difference shows that half of the time the System was within 7.4% of the YSI reference. Table 3: Difference Measures with YSI Reference Number of CGM-Reference Pairs Median Absolute Relative Difference (%) Mean Absolute Relative Difference (%) 9725 7.4 9.4 Agreement with BG Levels Agreement between the System and capillary blood glucose values (BG) as measured by the Readers built-in meter was characterized by using paired System CGM and BG value. The accuracy of CGM versus BG value was assessed by calculating the percentage of System readings that were within 15%, 20%, 30% and 40% for BG values 80 mg/dL and above, and within 15 mg/dL, 20 mg/dL, 30 mg/dL and 40 mg/dL for values below 80 mg/dL. The results are presented in Table 4 for BG values. Overall 87.0% of results were within 20 mg/dL / 20% of BG values. Table 4: Number and Percent of Results within BG Values*

CGM Glucose Level

(mg/dL) Number of CGM-Reference Pairs Within 15% /

15mg/dL Within 20% /

20mg/dL Within 30% /

30mg/dL Within 40% /

40mg/dL Outside 40% /

40mg/dL Overall 9234 40-50 51-80 81-180 181-300 301-400 401-500 123 795 4839 2800 563 114 75.8 52.0 60.5 73.3 83.8 82.4 80.7 87.0 62.6 71.9 85.9 92.8 93.6 93.0 96.1 78.0 88.2 96.4 98.4 98.0 97.4 98.6 89.4 95.0 98.9 99.4 99.3 98.2 1.4 10.6 5.0 1.1 0.6 0.7 1.8

* Comparison to BG was performed using the Readers built-in blood glucose meter. Different performance may be expected when compared to other models of blood glucose meters. 123 DOC40395_rev-A_manual.indd 123-124 124 10/23/18 1:16 PM Overall Accuracy against BG values Accuracy was measured by comparing the absolute relative difference between the System and BG values. The absolute relative difference measures the level of disagreement between the System and the BG value, but does not tell you whether the System glucose value was, on average, higher or lower than the BG value. The Mean Absolute Relative Difference gives an indication of the average percent disagreement between the CGM and the BG value. Table 5 shows the overall absolute difference measure. Overall the Mean Absolute Relative Difference was 11.4% for the comparison with BG value. The Median Absolute Relative Difference shows that half of the time the System was within 9.1% of the BG value. Table 5: Difference Measures with BG Value *

Number of CGM-Reference Pairs Median Absolute Relative Difference (%) Mean Absolute Relative Difference (%) 9234 9.1 11.4

* Comparison to BG was performed using the Readers built-in blood glucose meter. Different performance may be expected when compared to other models of blood glucose meters. Concurrence of System and Reference (CGM vs. YSI) The percentage of concurring glucose values (CGM vs. YSI) in each glucose reference range is presented for each CGM range in Table 6. For example, in the clinical study, when the System glucose results were within the 81 to 120 mg/dL range, actual blood glucose values were less than 40 mg/dL 0% of the time, between 40 and 60 mg/dL 0.1% of the time, between 61 and 80 mg/dL 2.7% of the time, between 81 and 120 mg/dL 68.1% of the time, between 121 and 160 mg/dL 27.7% of the time, between 161 and 200 mg/dL 1.2% of the time, between 201 and 250 mg/dL 0.1% of the time and above 250 mg/dL 0% of the time. 125 DOC40395_rev-A_manual.indd 125-126 126 10/23/18 1:16 PM Table 6: Concurrence Analysis by Glucose Level YSI Glucose Level (mg/dL)

<40* 40-60 61-80 81-

120 121-

160 161-

200 201-

250 251-

300 301-

350 351-

400 401-

500

>500*

CGM

(mg/dL)

<40 40-60 61-80 81-120 121-160 161-200 201-250 251-300 301-350 351-400 401-500

>500 0.0 2.8 0.2 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 44.4 33.3 22.2 31.0 48.3 17.9 34.0 59.0 68.1 27.7 4.9 0.1 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 2.7 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 7.0 0.2 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.2 1.1 0.0 0.0 0.0 0.0 0.0 0.3 0.3 71.2 20.7 11.1 68.8 18.5 15.0 72.8 11.6 0.0 0.0 2.0 0.3 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 1.2 0.5 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.1 1.0 2.7 0.0 0.0 0.0 23.5 65.3 10.6 33.3 56.6 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 7.3 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 1.4 0.0 0.0 20.8 66.7 11.1 0.0 0.0 21.4 78.6 0.0 92.3 N 18 145 636 0.0 0.0 0.0 0.0 2498 0.0 2625 0.0 1762 0.0 1186 0.0 554 0.0 0.0 0.0 7.7 219 72 28 13

* Levels out of system dynamic range. 127 DOC40395_rev-A_manual.indd 127-128 Concurrence Analysis by Glucose Trend Arrow Trend Arrow accuracy of the System, as assessed by concurrence analysis, is presented in Table 7. For example, in the clinical study, when the trend arrow indicated that glucose was changing slowly

(-1 to 1 mg/dL/min (g) ), actual glucose levels in the body were falling quickly (i) 0.2% of the time, falling (m) 2.6% of the time, changing slowly (g) 86.6% of the time, rising (k) 4.2% of the time, and rising quickly (h) 0.6% of the time. Table 7: Concurrence Analysis by Glucose Trend Arrow YSI (mg/dL/min) CGM

(mg/dL/min)

<-2

[-2, -1]

[-1, 0]

[0, 1]

[1, 2]

>2 NA*

<-2 (i) 39.9

-2 to -1 (m)

-1 to 1 (g) 1 to 2 (k)

>2 (h) NA 4.7 0.2 0.0 0.0 0.6 42.7 27.2 2.6 0.6 0.0 8.3 8.4 56.1 50.2 5.6 1.6 27.4 0.7 5.5 36.4 43.4 12.6 37.5 0.0 0.3 4.2 36.3 37.2 13.1 0.0 0.0 0.6 9.8 43.3 4.2 8.4 6.2 5.8 4.5 5.3 8.9 N 143 695 7786 717 247 168

* Glucose rate of change not available due to the time difference between glucose readings exceeding 30 minutes. Glucose Trend Arrow not available. 128 10/23/18 1:16 PM Agreement with LO and HI CGM Reading against YSI Reference The System reports glucose concentrations between 40 and 500 mg/dL. When the System determines that glucose level is below 40 mg/dL, it will report as LO. When the System determines that glucose level is above 500 mg/dL, it will report as HI. Table 8 displays the concurrence between the CGM and YSI reference glucose when CGM reads LO. For example, in the clinical study, when CGM reading was LO, YSI glucose values were less than 40 mg/dL 0.0% of the time, equal to or above 40 mg/dL 100.0% of the time, above 50 mg/dL 83.3% of the time, above 60 mg/dL 55.6% of the time, above 70 mg/dL 33.3% of the time, and above 80 mg/dL 22.2% of the time. Table 8: Concurrence Analysis with LO CGM Reading

% of CGM points in YSI range Number of CGM points in YSI range

<40 40 YSI (mg/dL)

>60

>50 0.0 0 100.0 83.3 18 15 55.6 10

>70 33.3 6

>80 22.2 4 N 18 Table 9 displays the concurrence between the CGM and YSI reference glucose when CGM reads HI. For example, in the clinical study, when CGM reading was HI, YSI glucose values were less than or equal to 200 mg/dL 0% of the time, above 200 mg/dL 100% of the time, above 300 mg/dL 100% of the time, above 400 mg/dL 100% of the time, and above 500 mg/dL 7.7% of the time. Table 9: Concurrence Analysis with HI CGM Reading YSI (mg/dL) 200 0.0 0

>200 100.0 13

>300 100.0 13

>400

>500 100.0 13 7.7 1 N 13

% of CGM points in YSI range Number of CGM points in YSI range 129 DOC40395_rev-A_manual.indd 129-130 Accuracy by Day of Wear The Sensor can be worn for up to 14 days. To show Sensor performance over time, the absolute relative difference between the System and reference YSI glucose values over the wear duration is presented in Table 10. Table 10: Difference Measures by Day (YSI Reference) Day 1 6 11 14 Number of CGM-

Reference Pairs Median Absolute Relative Difference (%) Mean Absolute Relative Difference (%) 2563 2545 2419 2198 8.3 7.1 7.4 6.6 10.8 8.5 9.3 9.1 130 10/23/18 1:16 PM The accuracy of CGM versus YSI reference and BG reference was assessed by calculating the percentage of System readings that were within 15%, 20%, 30% and 40% for reference values 80 mg/dL and above, and 15 mg/dL, 20 mg/dL, 30 mg/dL and 40 mg/dL for values below 80 mg/dL. The results for CGM vs. YSI reference are presented in Table 11. Table 11: Number and Percent of Results within YSI Reference Day Number of CGM-

Reference Pairs Within 15% /

15mg/dL Within 20% /

20mg/dL Within 30% /

30mg/dL Within 40% /

40mg/dL Outside 40% /

40mg/dL 1 6 11 14 2563 2545 2419 2198 78.2 87.0 82.3 83.9 87.0 94.5 90.0 91.3 95.6 99.4 98.2 96.2 98.7 99.8 99.9 99.0 1.3 0.2 0.1 1.0 System Glucose Availability The System is designed to produce a glucose reading after each user initiated scan that is performed throughout the wear period after the start-up time. Table 12 shows the number of available glucose readings reported by all Sensors and the expected number based on the total number of scan attempts. Results are shown for Sensors which produced at least one CGM reading during the clinical study over the total wear period. The percentage of available CGM readings is presented in comparison to the number of expected CGM readings. Overall, 99.6% (18,488 CGM readings out of an expected 18,562) were available. Table 12: CGM Availability No. CGM 18488 No. Scan 18562

99.6 131 DOC40395_rev-A_manual.indd 131-132 132 10/23/18 1:16 PM Alarm Performance Table 13a and Table 13b show the accuracy of the Systems Low and High Glucose Alarms. The Alarm Rate tells you how often the alarm is right or wrong. The Detection Rate tells you how often the System is able to recognize and notify you about a low or high glucose event. Low Glucose Alarm Performance Table 13a displays the percentages for these parameters:

True Alarm Rate Tells you: When you got a low glucose alarm, were you actually low?

Definition: Percentage of time the alarm issued and blood glucose was below the alarm level within 15 minutes before or after the alarm. False Alarm Rate Tells you: Did you get a low glucose alarm that you shouldnt have?

Definition: Percentage of time the alarm issued and blood glucose was not below the alarm level within 15 minutes before or after the alarm. Detection Rate Tells you: When you were low, did you get a low glucose alarm?

Definition: Percentage of time blood glucose was below the alarm level and the alarm issued within 15 minutes before or after the glucose event. Missed Detection Rate Tells you: When you were low, did you miss a low glucose alarm?

Definition: Percentage of time blood glucose was below the alarm level and the alarm didnt issue within 15 minutes before or after the glucose event. For example, the clinical study found that for a Low Glucose alarm level set to 70 mg/dL:

50.6% of the time a low glucose alarm was received when blood glucose was indeed below the alarm level but 49.4% of the time a low glucose alarm was received when blood glucose wasnt actually below the alarm level. 75.8% of the time blood glucose was below the alarm level and a low glucose alarm was appropriately issued but 24.2% of the time the glucose event was missed and no alarm was issued. Table 13a: Low Glucose Alarm Performance Low Glucose Alarm level

(mg/dL) Alarm Rate Detection Rate True Alarm Rate (%) False Alarm Rate (%) Correct Detection Rate

(%) Missed Detection Rate

(%) 60 70 80 90 42.9 50.6 56.9 59.6 57.1 49.4 43.1 40.4 74.4 75.8 80.8 85.5 25.6 24.2 19.2 14.5 133 DOC40395_rev-A_manual.indd 133-134 134 10/23/18 1:16 PM High Glucose Alarm Performance Table 13b displays the percentages for these parameters:

True Alarm Rate Tells you: When you got a high glucose alarm, were you actually high?

Definition: Percentage of time the alarm issued and blood glucose was above the alarm level within 15 minutes before or after the alarm. False Alarm Rate Tells you: Did you get a high glucose alarm that you shouldnt have?

Definition: Percentage of time the alarm issued and blood glucose was not above the alarm level within 15 minutes before or after the alarm. Detection Rate Tells you: When you were high, did you get a high glucose alarm?

Definition: Percentage of time blood glucose was above the alarm level and the alarm issued within 15 minutes before or after the glucose event. Missed Detection Rate Tells you: When you were high, did you miss a high glucose alarm?

Definition: Amount of time blood glucose was above the alarm level and the alarm didnt issue within 15 minutes before or after the glucose event. For example, the clinical study found that for a High Glucose alarm level set to 200 mg/dL:

87.3% of the time a high glucose alarm was received when blood glucose was indeed above the alarm level but 12.7% of the time a high glucose alarm was received when blood glucose wasnt actually above the alarm level. 81.5% of the time blood glucose was above the alarm level and a high glucose alarm was appropriately issued but 18.5% of the time the glucose event was missed and no alarm was issued. Table 13b: High Glucose Alarm Performance High Glucose Alarm level

(mg/dL) Alarm Rate Detection Rate True Alarm Rate (%) False Alarm Rate (%) Correct Detection Rate

(%) Missed Detection Rate

(%) 120 140 180 200 220 240 300 93.2 93.6 90.4 87.3 82.4 79.8 81.0 6.8 6.4 9.6 12.7 17.6 20.2 19.0 84.1 80.3 76.8 81.5 80.1 73.4 74.2 15.9 19.7 23.2 18.5 19.9 26.6 25.8 135 DOC40395_rev-A_manual.indd 135-136 136 10/23/18 1:16 PM Precision Precision of the System was evaluated by comparing the results from two separate Sensors worn on the same subject at the same time. Table 14 provides data from two separate Sensors worn on 95 subjects at the same time, providing 15,283 real-time pairs of CGM measurements, with a mean CV of 5.6%. Table 14: Overall between Sensor Precision Mean Glucose

(mg/dL) Median CV Mean CV Number of Subjects Number of Paired Readings 164.2 4.2 5.6 95 15283 Sensor Wear Duration The Sensor can be worn for up to 14 days. To estimate how long a Sensor will work over the wear duration, 190 Sensors were evaluated in the clinical study to determine how many days of readings each Sensor provided. Of these 190 Sensors, 136 (71.6%) lasted until the final day of use. 168 Sensors

(88.4%) lasted at least 7 days. There were 54 (28.4%) Sensors that failed early, of which 22 (11.6%) failed on or before the seventh day of wear. Adverse Events No device related serious adverse events occurred during the study. Mild skin irritations, such as erythema, bruising, bleeding, infection and papule were reported around the insertion site and adhesive area by a small number of subjects (8 out of 95 or 8.4%). Electromagnetic Compatibility (EMC) 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 users authority to operate the equipment. 137 DOC40395_rev-A_manual.indd 137-138 138 10/23/18 1:16 PM Guidance and manufacturers 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. Guidance and manufacturers 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. Emissions test Compliance RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations /

flicker emissions IEC 61000-3-3 Group 1 Class B Class A Complies Electromagnetic environment guidance 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. 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. IMMUNITY test IEC 60601 test level Compliance Level Electromagnetic environment guidance Electrostatic discharge (ESD) IEC 61000-4-2 8 kV contact 15 kV air 8 kV contact 15 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. 139 DOC40395_rev-A_manual.indd 139-140 140 10/23/18 1:16 PM IMMUNITY test Surge IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 IEC 60601 test level Compliance Level Electromagnetic environment guidance IMMUNITY test IEC 60601 test level Compliance Level Electromagnetic environment guidance 30 A/m 30 A/m Power frequency

(50/60 Hz) magnetic field IEC 61000-4-8 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. Mains power quality should be that of a typical domestic, commercial, or hospital environment. 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. 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode

<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 141 DOC40395_rev-A_manual.indd 141-142 142 10/23/18 1:16 PM IMMUNITY test Conducted RF IEC 61000-4-6 IEC 60601 test level Compliance Level Electromagnetic environment guidance 6 Vrms 150 kHz to 80 MHz 6 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

= 1.2 143 DOC40395_rev-A_manual.indd 143-144 IMMUNITY test Radiated RF IEC 61000-4-3 IEC 60601 test level Compliance Level Electromagnetic environment guidance 10 V/m 80 MHz to 2.7 GHz 10 V/m Recommended separation distance

= 1.2 d 80 MHz to 800 MHz

= 2.3 d 800 MHz to 2.5 GHz P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). 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. 144 10/23/18 1:16 PM 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 10 V/m. 145 DOC40395_rev-A_manual.indd 145-146 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. 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

= 2.3 d 0.01 0.1 1 10 100 0.12 0.38 1.2 3.8 12 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 23 146 10/23/18 1:16 PM 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. 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. Open Source Components: Material Design Icons Copyright 2014, Austin Andrews (http://materialdesignicons.com/), with Reserved Font Name Material Design Icons. Copyright 2014, Google (http://www.google.com/design/) uses the license at https://github.com/google/

material-design-icons/blob/master/LICENSE This Font Software is licensed under the SIL Open Font License, Version 1.1. This license is copied below, and is also available with a FAQ at: http://scripts.sil.org/OFL SIL OPEN FONT LICENSE Version 1.1 - 26 February 2007 PREAMBLE The goals of the Open Font License (OFL) are to stimulate worldwide development of collaborative font projects, to support the font creation efforts of academic and linguistic communities, and to provide a free and open framework in which fonts may be shared and improved in partnership with others. The OFL allows the licensed fonts to be used, studied, modified and redistributed freely as long as they are not sold by themselves. The fonts, including any derivative works, can be bundled, embedded, redistributed and/or sold with any software provided that any reserved names are not used by derivative works. The fonts and derivatives, however, cannot be released under any other type of license. The requirement for fonts to remain under this license does not apply to any document created using the fonts or their derivatives. 147 DOC40395_rev-A_manual.indd 147-148 148 10/23/18 1:16 PM DEFINITIONS Font Software refers to the set of files released by the Copyright Holder(s) under this license 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 refers to the collection of Font Software components as distributed by the Copyright Holder(s). Modified Version refers to any derivative made by adding to, deleting, or substituting in part or in whole any of the components of the Original Version, by changing formats or by porting the Font Software to a new environment. Author refers to any designer, engineer, programmer, technical writer or other person who contributed to the Font Software. PERMISSION & CONDITIONS Permission is hereby granted, free of charge, to any person obtaining a copy of the Font Software, to use, study, copy, merge, embed, modify, redistribute, and sell modified and unmodified copies of the Font Software, subject to the following conditions:

1) Neither the Font Software nor any of its individual components, in Original or Modified Versions, may be sold by itself. 2) Original or Modified Versions of the Font Software may be bundled, redistributed and/or sold with any software, provided that each copy contains the above copyright notice and this license. These can be included either as stand-alone text files, human-readable headers or in the appropriate machine-readable metadata fields within text or binary files as long as those fields can be easily viewed by the user. 3) No Modified Version of the Font Software may use the Reserved Font Name(s) unless explicit written permission is granted by the corresponding Copyright Holder. This restriction only applies to the primary font name as presented to the users. 4) The name(s) of the Copyright Holder(s) or the Author(s) of the Font Software shall not be used to promote, endorse or advertise any Modified Version, except to acknowledge the contribution(s) of the Copyright Holder(s) and the Author(s) or with their explicit written permission. 149 DOC40395_rev-A_manual.indd 149-150 5) The Font Software, modified or unmodified, in part or in whole, must be distributed entirely under this license, and must not be distributed under any other license. The requirement for fonts to remain under this license does not apply to any document created using the Font Software. TERMINATION This license becomes null and void if any of the above conditions are not met. DISCLAIMER THE FONT SOFTWARE IS PROVIDED AS IS, WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT OF COPYRIGHT, PATENT, TRADEMARK, OR OTHER RIGHT. IN NO EVENT SHALL THE COPYRIGHT HOLDER BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER LIABILITY, INCLUDING ANY GENERAL, SPECIAL, INDIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES, WHETHER IN AN ACTION OF CONTRACT, TORT OR OTHERWISE, ARISING FROM, OUT OF THE USE OR INABILITY TO USE THE FONT SOFTWARE OR FROM OTHER DEALINGS IN THE FONT SOFTWARE. 150 10/23/18 1:16 PM Limited Warranty We hope that you are happy with your FreeStyle Libre 2 system . Please refer to the Users Manual before using your Reader for the first time . Abbott Diabetes Care (Abbott) warrants that the FreeStyle Libre 2 reader (Reader) shall be free from defects in material and workmanship for a period of one (1) year from the date of manufacture or one (1) year from the original date of purchase with proof of purchase (whichever is later) . This Limited Warranty is invalid if the Reader is modified, altered, damaged, misused or used other than in accordance with the Users Manual, applicable labeling, and/or inserts . Abbotts sole obligation is to replace the Reader, free of charge, with the same or an alternative reader as determined by Abbott in its sole discretion . Your replacement may be a different model or type . Abbott may require, as a condition of obtaining limited warranty service, that you return the Reader postage prepaid, with proof of purchase to an address specified by Abbott . The Limited Warranty on the replacement Reader will expire on the date of the original Limited Warranty expiration or 90 days after the shipment of a replacement Reader, whichever period is longer . This Limited Warranty covers only the Reader, does not cover the sensor or disposable accessories, extends only to the original purchaser, and is not assignable or transferable . TO THE EXTENT POSSIBLE UNDER LAW, THE FOREGOING ARE ABBOTTS ONLY WARRANTIES FOR THE READER AND STATE YOUR EXCLUSIVE REMEDY . ABBOTT MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, AND ABBOTT EXCLUDES AND DISCLAIMS ANY OTHER WARRANTIES INCLUDING, BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE . ABBOTT DOES NOT WARRANT THAT OPERATION OF THE READER WILL 151 DOC40395_rev-A_manual.indd 151-152 BE UNINTERRUPTED OR ERROR FREE AND ABBOTT WILL NOT BE LIABLE FOR ANY LOST PROFITS, LOST SAVINGS OR OTHER SPECIAL, PUNITIVE, INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING DIRECTLY OR INDIRECTLY FROM PURCHASE, OPERATION OR USE OF THE READER OR FAILURE OF THE READER TO PERFORM IN ACCORDANCE WITH SPECIFICATIONS . NO WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, IF ANY IS IMPLIED FROM THE SALE OF THE READER DESPITE ABBOTTS SPECIFIC DISCLAIMER OF SUCH WARRANTIES, SHALL EXTEND FOR A LONGER DURATION THAN ONE YEAR FROM THE ORIGINAL DATE OF PURCHASE OF THE READER . This Limited Warranty and any dispute or claim arising out of or in connection with it shall be governed by and construed in accordance with the laws of Delaware . Some states do not allow limitations on how long an implied warranty lasts or the exclusion or limitation of incidental or consequential damages, so the above limitations or exclusions may not apply to you . Your Rights Under State Law: This Limited Warranty gives you specific legal rights, and you may also have other rights that vary from state to state . FreeStyle, Libre, and related brand marks are trademarks of Abbott Diabetes Care Inc . in various jurisdictions . LIMITED WARRANTY SERVICES For questions or warranty service, contact Customer Service at 1-855-632-8658 . ABBOTT MAY MODIFY OR DISCONTINUE THIS PROGRAM AT ANY TIME WITHOUT NOTICE. 152 10/23/18 1:16 PM References:

1 FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication

(2010) http://www .fda .gov/MedicalDevices/Safety/AlertsandNotices/ucm224025 . htm 2 CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens (2010) http://www .cdc .gov/injectionsafety/Fingerstick-DevicesBGM .html 3 American Diabetes Association, Classification and Diagnosis of Diabetes, 2017 . Diabetes Care 40(Suppl . 1):S11S2 153 DOC40395_rev-A_manual.indd 153 10/23/18 1:16 PM

ART39562_rev-A.pdf 1 3/28/18 5:23 PM Dieline is shown for reference only. Do not print dieline. Human readable serial number and 2-D barcode printed online. FLASH GLUCOSE MONITORING SYSTEM ABCYXXX-XXXXX www.FreeStyleLibre.com Customer Service: 1-855-632-8658 FCC ID: QXS-LIB02 8 1

3 0 A

. v e R 2 6 5 9 3 T R A Abbott Diabetes Care Inc. 1360 South Loop Road Alameda, CA 94502 USA Product of China DRAWING NO.:

ART39562 PAGE:

1 of 1 REV.:

A SCALE:

1/1 BLACK 90%

BLACK 30%

Hila Ralston Abbott Diabetes Care 1360 South Loop Road Alameda, CA 94502

(510) 749-5400 Date: 21-April-2021 Subject: Confidentiality Request for FCC ID: ___QXS-LIB02_____ Pursuant to FCC 47 CRF 0.457(d) and 0.459 and IC RSP-100, Section 10, the applicant requests that a part of the subject FCC/IC application be held confidential. Type of Confidentiality Requested Short Term Short Term Permanent Permanent Short Term Permanent Short Term Short Term Short Term Permanent Permanent Permanent Exhibit All Block Diagrams Internal and External Photos Operation Description/Theory of Operation All Schematics Users Manuals Assembly Drawings Abbott Diabetes Care_ has spent substantial effort in developing this product and it is one of the first of its kind in industry. Having the subject information easily available to

"competition" would negate the advantage they have achieved by developing this product. Not protecting the details of the design will result in financial hardship. Permanent Confidentiality:

The applicant requests the exhibits listed above as permanently confidential be permanently withheld from public review due to materials that contain trade secrets and proprietary information not customarily released to the public. Short-Term Confidentiality:

The applicant also requests that the exhibits listed above as short term confidential be withheld from public view for a period of 180 days from the date of the Grant of Equipment Authorization and prior to marketing. This is to avoid premature release of sensitive information prior to marketing or release of the product to the public. Applicant is also aware that they are responsible to notify TUV Rheinland in the event information regarding the product or the product is made available to the public. TUV Rheinland will then release the documents listed above for public disclosure pursuant to FCC Public Notice DA 04-1705. By:

(Signature/Title) ________________________

(Print name) Sincerely, Page 1/1 Hila Ralston