QXS-LIB02SGlucose Monitoring Sensor

User’s Manual ©2020-2021 Abbott DOC40703 Rev. K 03/21 The circular shape of the sensor housing, FreeStyle, Libre, and related brand marks are marks of Abbott. Other trademarks are the property of their respective owners. Patent: https://www.abbott.com/patents Distributed by: Abbott Diabetes Care Inc. 1360 South Loop Road Alameda, CA 94502 USA Customer Service: 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Standard Time www.FreeStyleLibre.com FLASH GLUCOSE MONITORING SYSTEM Manufacturer CAUTION: Federal law restricts this device to sale by or on the order of a physician. .224” .257” 4.6”4.6” DOC40703_rev-K_cover.indd 1-2DOC40703_rev-K_cover.indd 1-23/19/21 9:14 AM3/19/21 9:14 AM Your Name _________________________________________________ .224” .257” 4.6”4.6” DOC40703_rev-K_cover.indd 3-4DOC40703_rev-K_cover.indd 3-43/19/21 9:14 AM3/19/21 9:14 AM WARNING: Before you use the FreeStyle Libre 2 System, review all the product instructions and the Interactive Tutorial. The Quick Reference Guide and Interactive Tutorial give you quick access to important aspects and limitations of the System. The User’s Manual includes all safety information and instructions for use. Talk to your health care professional about how you should use your Sensor glucose information to help manage your diabetes. Failure to use the System according to the instructions for use may result in you missing a severe low blood glucose or high blood glucose event and/or making a treatment decision that may result in injury. If your glucose alarms and readings from the System do not match symptoms or expectations, use a fingerstick blood glucose value from a blood glucose meter to make diabetes treatment decisions. Seek medical attention when appropriate. DOC40703_rev-K_manual.indd 1DOC40703_rev-K_manual.indd 13/19/21 9:13 AM3/19/21 9:13 AM Contents Important Safety Information...........................1 Indications For Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Compatible Devices, Apps, and Software..................2 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Warnings.................................................3 Cautions and Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Interfering Substances...................................12 Reader Symbols........................................13 Getting to Know Your System . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Reader Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Sensor Kit ...............................................18 FreeStyle Libre Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Setting up Your Reader for the First Time . . . . . . . . . . . . . . 22 Using Your Sensor......................................25 Applying Your Sensor....................................26 Starting Your Sensor.....................................30 Checking Your Glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Making Treatment Decisions...........................37 Making Treatment Decisions – Getting Started ...........38 Using Your Glucose Reading to Make a Treatment Decision .....................................43 DOC40703_rev-K_manual.indd 2-3DOC40703_rev-K_manual.indd 2-33/19/21 9:13 AM3/19/21 9:13 AM Alarms..................................................56 Setting Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59 Setting Alarm Sounds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64 Using Alarms............................................65 Adding Notes...........................................67 Reviewing Your History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 Logbook . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71 Daily Graph .............................................72 Other History Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73 Removing Your Sensor .................................75 Replacing Your Sensor .................................76 Using Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77 Using the Reader’s Built-in Meter . . . . . . . . . . . . . . . . . . . . . . 79 Intended Use............................................79 Blood Glucose Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83 Control Solution Testing .................................90 Charging the Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95 Changing the Reader Settings .........................96 Living With Your System................................99 Maintenance and Disposal ............................102 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .107 Reader Does Not Power On . . . . . . . . . . . . . . . . . . . . . . . . . . . . .107 Problems at the Sensor Application Site.................108 Problems Starting Your Sensor or Receiving Sensor Readings........................................109 Problems Receiving Glucose Alarms.....................113 Blood Glucose Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . .115 Problems Checking Your Blood Glucose . . . . . . . . . . . . . . . . .119 Perform a Reader Test...................................121 Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .121 System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .122 Labeling Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .128 Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . .130 Electromagnetic Compatibility (EMC).................160 Limited Warranty.............................…

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Abbott Diabetes Care 1360 South Loop Road Alameda, CA 94502 (510) 749-5400 Authority to Act as Agent Date: 2-Nov-20 Abbott Diabetes Care 1360 South Loop Road Alameda, CA 94502 To Whom It May Concern: I appoint TUV Rheinland Group to act as our agent in the preparation of this application for equipment certification. I certify that submitted documents properly describe the device or system for which equipment certification is sought. I also certify that each unit manufactured, imported or marketed, as defined in the FCC or Industry Canada’s regulations will have affixed to it a label identical to that submitted for approval with this application. For instances where our authorized agent signs the application for certification on our behalf, I acknowledge that all responsibility for complying with the terms and conditions for Certification, as specified by TUV Rheinland Group, still resides with Abbott Diabetes Care, 1360 South Loop Road, Alameda, CA 94502. For TCB applications, we certify that we are not subject to denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862. Further, no party, as defined in 47 CFR 1.2002 (b), to the application is subject to denial of federal benefits, that includes FCC benefits. Thank you, Agency Agreement Expiration Date: _____2-Nov-2021_____ By: __________________________ __________________________ (Signature) (Print name) Title:__________________________ Telephone:__________________________ On behalf of: _________________________ (Company Name) Hila Ralston R&D Principal Electrical Eng 510.864.4522 Abbott Diabetes Care

Pag e 1/1 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_____ Pur suant 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 Exhibit Short Term Permanent All Block Diagrams Short Term Permanent Internal and External Photos Short Term Permanent Operation Description/Theory of Operation Short Term Permanent All Schematics Short Term Permanent User’s Manuals Short Term Permanent 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. Pe rmanent 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. Shor t-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 re garding 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. Si ncerely, By: __________________________ ________________________ (Signature/Title) (Print name) Hila Ralston

Page 1/1 Hila Ralston Abbott Diabetes Care 1360 South Loop Road Alameda, CA 94502 (510) 749-5400 Date: 22-Feb-2021 FREESTYLE LIBRE 2 SENSOR EXTERNAL PHOTOS Photo 1- External Top View of the Sensor Photo 2- External Bottom View of the Sensor Photo 3- External Bottom View of the Sensor without Sensor Plug

NO COAT AREA NO COAT AREA 000000000000 40399F40399F40399F Open Here | Open Here The Sensor Pack and Sensor Applicator are packaged as a set and are intended to be used together. The Sensor Pack and Sensor Applicator are packaged as a set and are intended to be used together. SENSOR Scan the Sensor for Glucose Reading in 1 Second Scan the Sensor for Glucose Reading in 1 Second The circular shape of the sensor housing, FreeStyle, Libre, and related brand marks are marks of Abbott. Other trademarks are the property of their respective owners. ©2021 Abbott Patent | Patent: https://www.abbott.com/patents DOC40399 Rev. F 03/21 NDC XXXXX-XXXX-XX CONTENTS: 1 Sensor Applicator 1 Sensor Pack 2 Alcohol Wipes Product Insert CONTENTS: 1 Sensor Applicator 1 Sensor Pack 2 Alcohol Wipes Product Insert 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. | 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. Distributed by | Distributed by: (Place distribution and/or contact information here.) Sensor Applicator and Sensor Pack products of Ireland. | Sensor Applicator and Sensor Pack products of Ireland. Type BF applied part Type BF applied part Consult instructions for use Consult instructions for use Do not re-use Do not re-use Catalog number Catalog number Do not use if package is damaged Do not use if package is damaged Humidity limitation Humidity limitation Temperature limit Temperature limit Manufacturer Manufacturer For use with FreeStyle Libre 2 Reader For use with FreeStyle Libre 2 Reader FreeStyleLibre.com XXXXX-XX *Low Glucose, High Glucose, Signal Loss FCC ID: QXS-LIB02S Area for UDI 55 mm 40 mm FLASH GLUCOSE MONITORING SYSTEM FLASH GLUCOSE MONITORING SYSTEM Not For Retail Sale Not For Retail Sale NOW WITH OPTIONAL ALARMS * Placeholder for sku Placeholder for copyright year Use for Medicare carton: Placeholder for NDC number For Medicare Remove banner for retail cartons. Remove for SKUs manufactured at Bualo Grove DOC40399_rev-F.pdf 1 3/22/21 3:26 PM

NO COAT AREA NO COAT AREA 000000000000 40399F40399F40399F Open Here | Open Here The Sensor Pack and Sensor Applicator are packaged as a set and are intended to be used together. The Sensor Pack and Sensor Applicator are packaged as a set and are intended to be used together. SENSOR Scan the Sensor for Glucose Reading in 1 Second Scan the Sensor for Glucose Reading in 1 Second The circular shape of the sensor housing, FreeStyle, Libre, and related brand marks are marks of Abbott. Other trademarks are the property of their respective owners. ©2021 Abbott Patent | Patent: https://www.abbott.com/patents DOC40399 Rev. F 03/21 NDC XXXXX-XXXX-XX CONTENTS: 1 Sensor Applicator 1 Sensor Pack 2 Alcohol Wipes Product Insert CONTENTS: 1 Sensor Applicator 1 Sensor Pack 2 Alcohol Wipes Product Insert 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. | 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. Distributed by | Distributed by: (Place distribution and/or contact information here.) Sensor Applicator and Sensor Pack products of Ireland. | Sensor Applicator and Sensor Pack products of Ireland. Type BF applied part Type BF applied part Consult instructions for use Consult instructions for use Do not re-use Do not re-use Catalog number Catalog number Do not use if package is damaged Do not use if package is damaged Humidity limitation Humidity limitation Temperature limit Temperature limit Manufacturer Manufacturer For use with FreeStyle Libre 2 Reader For use with FreeStyle Libre 2 Reader FreeStyleLibre.com XXXXX-XX *Low Glucose, High Glucose, Signal Loss FCC ID: QXS-LIB02S Area for UDI 55 mm 40 mm FLASH GLUCOSE MONITORING SYSTEM FLASH GLUCOSE MONITORING SYSTEM Not For Retail Sale Not For Retail Sale NOW WITH OPTIONAL ALARMS * Placeholder for sku Placeholder for copyright year Use for Medicare carton: Placeholder for NDC number For Medicare Remove banner for retail cartons. Remove for SKUs manufactured at Bualo Grove DOC40399_rev-F.pdf 1 3/22/21 3:26 PM

40710G 1 4 7 2 5 8 6 9 STEP 1: Select site on back of upper arm. STEP 2: Wash site using a plain soap, dry, and then clean with alcohol wipe. Allow site to air dry before proceeding. STEP 3: Peel lid completely off Sensor Pack. Unscrew cap from Sensor Applicator. CAUTION: Sensor codes must match on Sensor Pack and Sensor Applicator. Do NOT use if damaged or already opened. STEP 4: Line up dark marks on Sensor Applicator and Sensor Pack. On a hard surface, press down firmly on Sensor Applicator until it comes to a stop. STEP 5: Lift Sensor Applicator out of Sensor Pack. STEP 6: Sensor Applicator is ready to apply Sensor. CAUTION: Sensor Applicator now contains a needle. Do not touch inside Sensor Applicator or put it back into Sensor Pack. STEP 7: Place Sensor Applicator over site. Push down firmly to apply Sensor. CAUTION: Do NOT push down on Sensor Applicator until placed over prepared site to prevent unintended results or injury. STEP 8: Gently pull Sensor Applicator away. STEP 9: Make sure Sensor is secure. Discard used Sensor Applicator and Sensor Pack according to local regulations. To use your System, refer to the User’s Manual included in the Reader Kit. FreeStyle Libre 2 Sensor - FCC ID: QXS-LIB02S 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. CAUTION: Changes or modifications not approved by Abbott could void the user’s authority to operate the equipment. 3 2.25” 2.2” 2.25” 2.25” 2.2” 2.25” Front 3rd fold2nd fold 1st fold (to half ) Final Facing Fold Language 2 DOC40710_rev-G.indd 1DOC40710_rev-G.indd 13/15/21 3:36 PM3/15/21 3:36 PM FreeStyle Libre 2 Flash Glucose Monitoring System READ THIS INSERT AND THE READER KIT USER’S MANUAL BEFORE HANDLING THE SENSOR KIT PARTS. CAUTION: Federal law restricts this device to sale by or on the order of a physician. Indications for Use The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The System also detects trends and tracks patterns and aids 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 also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions. Compatible Devices, Apps, and Software For a list of compatible devices, apps, and software that can be used with the FreeStyle Libre 2 Sensor, please go to: https://freestylelibre.us/support/overview.html Use of the Sensor with devices, apps, and software that are not listed may cause inaccurate glucose readings. CONTRAINDICATIONS Automated Insulin Dosing: The System must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems. 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. WARNING: • 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. • Use your blood glucose meter to make diabetes treatment decisions when you see the symbol during the first 12 hours of wearing a Sensor, if your Sensor glucose reading does not match how you feel, or if the reading does not include a number. • Choking hazard: The System contains small parts that may be dangerous if swallowed. CAUTION: • For you to receive alarms, they must be on and your device 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. • If you believe your readings are not correct or are inconsistent with how you feel, perform a blood glucose test on your finger to confirm your glucose and check to make sure your Sensor has not come loose. If the problem continues or if your Sensor is coming loose, remove the current Sensor, apply a new one, and contact Customer Service. • Intense exercise may cause your Sensor to loosen due to sweat or movement of 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 low readings. Remove and replace your Sensor if it starts to loosen and follow the instructions to select an appropriate application site. Do not attempt to reinsert the Sensor. Contact Customer Service if your Sensor becomes loose or falls off before the end of the wear period. Customer Service is available at 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Standard Time. • 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 unreliable low results. • The Sensor Pack and Sensor Applicator are packaged as a set 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 inc…

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40710G 1 4 7 2 5 8 6 9 STEP 1: Select site on back of upper arm. STEP 2: Wash site using a plain soap, dry, and then clean with alcohol wipe. Allow site to air dry before proceeding. STEP 3: Peel lid completely off Sensor Pack. Unscrew cap from Sensor Applicator. CAUTION: Sensor codes must match on Sensor Pack and Sensor Applicator. Do NOT use if damaged or already opened. STEP 4: Line up dark marks on Sensor Applicator and Sensor Pack. On a hard surface, press down firmly on Sensor Applicator until it comes to a stop. STEP 5: Lift Sensor Applicator out of Sensor Pack. STEP 6: Sensor Applicator is ready to apply Sensor. CAUTION: Sensor Applicator now contains a needle. Do not touch inside Sensor Applicator or put it back into Sensor Pack. STEP 7: Place Sensor Applicator over site. Push down firmly to apply Sensor. CAUTION: Do NOT push down on Sensor Applicator until placed over prepared site to prevent unintended results or injury. STEP 8: Gently pull Sensor Applicator away. STEP 9: Make sure Sensor is secure. Discard used Sensor Applicator and Sensor Pack according to local regulations. To use your System, refer to the User’s Manual included in the Reader Kit. FreeStyle Libre 2 Sensor - FCC ID: QXS-LIB02S 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. CAUTION: Changes or modifications not approved by Abbott could void the user’s authority to operate the equipment. 3 2.25” 2.2” 2.25” 2.25” 2.2” 2.25” Front 3rd fold2nd fold 1st fold (to half ) Final Facing Fold Language 2 DOC40710_rev-G.indd 1DOC40710_rev-G.indd 13/15/21 3:36 PM3/15/21 3:36 PM FreeStyle Libre 2 Flash Glucose Monitoring System READ THIS INSERT AND THE READER KIT USER’S MANUAL BEFORE HANDLING THE SENSOR KIT PARTS. CAUTION: Federal law restricts this device to sale by or on the order of a physician. Indications for Use The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The System also detects trends and tracks patterns and aids 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 also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions. Compatible Devices, Apps, and Software For a list of compatible devices, apps, and software that can be used with the FreeStyle Libre 2 Sensor, please go to: https://freestylelibre.us/support/overview.html Use of the Sensor with devices, apps, and software that are not listed may cause inaccurate glucose readings. CONTRAINDICATIONS Automated Insulin Dosing: The System must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems. 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. WARNING: • 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. • Use your blood glucose meter to make diabetes treatment decisions when you see the symbol during the first 12 hours of wearing a Sensor, if your Sensor glucose reading does not match how you feel, or if the reading does not include a number. • Choking hazard: The System contains small parts that may be dangerous if swallowed. CAUTION: • For you to receive alarms, they must be on and your device 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. • If you believe your readings are not correct or are inconsistent with how you feel, perform a blood glucose test on your finger to confirm your glucose and check to make sure your Sensor has not come loose. If the problem continues or if your Sensor is coming loose, remove the current Sensor, apply a new one, and contact Customer Service. • Intense exercise may cause your Sensor to loosen due to sweat or movement of 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 low readings. Remove and replace your Sensor if it starts to loosen and follow the instructions to select an appropriate application site. Do not attempt to reinsert the Sensor. Contact Customer Service if your Sensor becomes loose or falls off before the end of the wear period. Customer Service is available at 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Standard Time. • 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 unreliable low results. • The Sensor Pack and Sensor Applicator are packaged as a set 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 inc…

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Page 1/1 Hila Ralston Abbott Diabetes Care 1360 South Loop Road Alameda, CA 94502 (510) 749-5400 Date: 22-Feb-2021 FREESTYLE LIBRE 2 SENSOR INTERNAL PHOTOS Photo 1- Internal View of the Sensor Top Photo2- Bottom Internal View of the Sensor circuit

Report Number: 31863611. 001 Page 1 of 69 EUT: Glucose Monitoring System SensorSensor Model: Freestyle Libre 2 Sensor EMC / Rev 1 FCC ID: QXS-LIB02 IC ID: 12106A-LIB02S Emissions Test Report EUT Name: Glucose Monitoring System Sensor Model No.: Freestyle Libre 2 Sensor CFR 47 Part 15.247: 2018 and RSS 247: 2017 Prepared f or: Abbott Diabetes Care 1360 S. Loop Road Alameda, CA 94502 Prepared by: TUV Rheinland of North America, Inc. 1279 Quarry Lane, Suite A Pleasanton, CA 94566 Tel: (925) 249-9123 Fax: (925) 249-9124 http://www.tuv.com/ Report/Issue Date: Job # 2/26/2021 0000158109 Report Number: 31863611.001 Report Number: 31863611. 001 Page 2 of 69 EUT: Glucose Monitoring System SensorSensor Model: Freestyle Libre 2 Sensor EMC / Rev 1 FCC ID: QXS-LIB02 IC ID: 12106A-LIB02S Revisions Revision No. Date Reason for Change Author 0 2/26/2021 Original Document DA 1 2/26/21 Updated, IC ID: 12106A-LIB02S RD Note: Latest revision report will replace all previous reports. Statement of Compliance Report Number: 31863611. 001 Page 3 of 69 EUT: Glucose Monitoring System SensorSensor Model: Freestyle Libre 2 Sensor EMC / Rev 1 FCC ID: QXS-LIB02 IC ID: 12106A-LIB02S Manuf acturer: Abbott Diabetes Care 1360 S. Loop Road Alameda, CA 94502 Requester / Applicant: Abbott Diabetes Care Name of Equipment: Glucose Monitoring System Sensor Model No. Freestyle Libre 2 Sensor Type of Equipment: Intentional Radiator Application of Regulations: CFR 47 Part 15.247: 2018 and RSS 247: 2017 Test Dates: 8/20/2018, 8/19/20 Guidance Documents: Emissions: ANSI C63.10-2013 Test Methods: Emissions: ANSI C63.10-2013 The electromagnetic compatibility test and documented data described in this report has been performed and recorded by TUV Rheinland, in accordance with the standards and procedures listed herein. As the responsible authorized agent of the EMC laboratory, I hereby declare that the equipment described above has been shown to be compliant with the EMC requirements of the stated regulations and standards based on these results. If any special accessories and/or modifications were required for compliance, they are listed in the Executive Summary of this report. This report must not be used to claim product endorsement by A2LA or any agency of the U.S. Government. This report shall not be reproduced except in full, without the written authorization of TUV Rheinland of North America. Rachana Khanduri Richard Decker Test Engineer Date February 26, 2021 A2LA Signatory Date February 26, 2021 Te s ting Ce rt #3331.02 US1131 2932M-1 Table of Contents Report Number: 31863611. 001 Page 4 of 69 EUT: Glucose Monitoring System SensorSensor Model: Freestyle Libre 2 Sensor EMC / Rev 1 FCC ID: QXS-LIB02 IC ID: 12106A-LIB02S 1 Executive Summary ____________________________________________________ 7 1.1 Scope _____________________________________________________________________ 7 1.2 Purpose ___________________________________________________________________ 7 1.3 Summary of Test Results _____________________________________________________ 8 1.4 Special Accessories __________________________________________________________ 8 1.5 Equipment Modifications ____________________________________________________ 8 2 Laboratory Information _______________…

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