QXS-LIB02Glucose Monitoring Reader

User’s Manual ©2018 Abbott DOC40395 Rev. A 10/18 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 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 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” DOC40395_rev-A_cover.indd 1-210/23/18 1:16 PM Your Name _________________________________________________ .224” .257” 4.6”4.6” DOC40395_rev-A_cover.indd 3-410/23/18 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 110/23/18 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 Using Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70 Using the Reader’s Built-in Meter . . . . . . . . . . . . . . . . . . . . . . 72 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72 Blood Glucose Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75 Control Solution Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81 Charging the Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86 Changing the Reader Settings . . . . . . . . . . . . . . . . . . . . . . . . .87 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 System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .113 Labeling Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .118 Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . .120 Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . . . .138 Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .151 DOC40395_rev-A_manual.indd 2-310/23/18 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 deci…

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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: 24-Feb-2021 FREESTYLE LIBRE 2 EXTERNAL PHOTOS Photo 1- Overall Top External View of Reader Photo 2- Overall Bottom External View of Reader

DRAWING NO.: ART39562 PAGE: 1 of 1 SCALE: 1/1 REV.: A BLACK 90%BLACK 30% Dieline is shown for reference only. Do not print dieline. Human readable serial number and 2-D barcode printed online. ABCYXXX-XXXXX Abbott Diabetes Care Inc. 1360 South Loop Road Alameda, CA 94502 USA Customer Service: 1-855-632-8658 FCC ID: QXS-LIB02 www.FreeStyleLibre.com Product of China ART39562 Rev. A 03/18 FLASH GLUCOSE MONITORING SYSTEM ART39562_rev-A.pdf 1 3/28/18 5:23 PM

Page 1/3 Hila Ralston Abbott Diabetes Care 1360 South Loop Road Alameda, CA 94502 (510) 749-5400 Date: 24-Feb-2021 FREESTYLE LIBRE 2 INTERNAL PHOTOS Photo 1- Internal Top View of Reader Photo 2- Internal Top View of Reader with Bobbin Removed Page 2/3 Photo 3- Internal Top View of Reader without Screen Photo 4- Internal Top View of Reader with Screen Removed Photo 5- Bare Internal Top View of Reader Photo 6- Internal Bottom View of Reader Page 3/3 Photo 7- Internal Bottom View of Reader with Battery Clip Removed Photo 8- Internal Bare Bottom View of Reader

Page 1/1 Hila Ralston Abbott Diabetes Care 1360 South Loop Road Alameda, CA 94502 (510) 749-5400 Date: 21-Apr-2021 SAR Test Exhibit The FCC General RF Exposure Guidance 447498 D01 demonstrates compliance of wireless communication devices with the basic restrictions and exposure limit values related to human exposure to electromagnetic fields in the frequency range 100 MHz to 6 GHz. Specific Absorption Rate (SAR) is the unit of measurement of the amount of radio frequency (RF) absorbed by the body when using a wireless device. This section is included to document why the RF Exposure Guidance does not apply because the power level is below the exclusion limit. The FCC SAR for BLE Mode test exclusion comes from section 4.3.1a of 447498 D01 General RF Exposure Guidance. 10-g SAR is limited to limbs of the human body and is used to calculate this exclusion as follows: For 100 MHz to 6 GHz and test separation distances ≤ 50 mm, 10-g SAR test exclusion thresholds are determined by the following formula and when calculated is equal to or below 7.5. ൬ ܲ ܦ ൰∙൫ ඥ ݂ ீு௭ ൯൑7.5 P: is maximum power in mW D: is Separation Distance in mm and x is the number of different measurement points fGHz: is the RF channel transmit frequency in GHz f = 2.487GHz which is the highest BLE channel or worst case for calculations P = 7.2mW which is maximum power or worst case for calculations. D1 = 11.11mm Reader pcb antenna which represents the worst case for calculations. ૚.૙૛ൌ൬ ܹ݉7.2 11.11݉݉ ൰ൈ √ ݖܪܩ2.487݃10െ ݎ݋݂૞.൑ૠ

TUV Rheinland Job #158109 1279 Quarry Lane, Ste. A, Pleasanton, CA 95466 Tel: (925) 249-9123, Fax: (925) 249-9124 Report# 31863002.002 Page 1 of 29 Report Date: July 23, 2018 Emissions Test Report EUT Name: Freestyle Libre 2 Model No.: Freestyle Libre 2 CFR 47 Part 15.225: 2017, RSS 210 Issue 9 Prepared f or: Client Abbott Diabetes Care Address 1360 South Loop Road Address Alameda, CA 94502 Contact Person Richard Ries e-mail [email protected] Prepared by: TUV Rheinland of North America, Inc. 1279 Quarry Lane, Ste. A Pleasanton, CA 94566 U.S.A. Tel: (925) 249-9123 Fax: (925) 249-9124 http://www.tuv.com/ TUV Rheinland Job #158109 1279 Quarry Lane, Ste. A, Pleasanton, CA 95466 Tel: (925) 249-9123, Fax: (925) 249-9124 Report# 31863002.002 Page 2 of 29 Report Date: July 23, 2018 Revisions Revision No. Date MM/DD/YYYY Reason for Change Author 1 08/15/2018 Initial D. Foster 2 2/26/21 Updated, Model No.: Freestyle Libre 2 RD Note: Latest revision report will replace all previous reports. TUV Rheinland Job #158109 1279 Quarry Lane, Ste. A, Pleasanton, CA 95466 Tel: (925) 249-9123, Fax: (925) 249-9124 Report# 31863002.001 Page 3 of 29 Report Date: July 23, 2018 Statement of compliance Manufacturer: Abbott Diabetes Care Requester / Applicant: Richard Ries Name of Equipment: Freestyle Libre 2 Model No. 22175 Type of Equipment: Patch reader Application of Regulations: Rules for digital transmission systems Test Dates: 07/27/2018, 8/19/20 Guidance Documents: Emissions: ANSI C63.10-2013 CFR47 part 15.225:2018 and RSS 210 Issue 9 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 sec. 1.4 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 September 18, 2018 Richard Decker September 18, 2018 Test Engineer Date Laboratory Signature Date INDUSTRY CANADA Te s ting Ce rt #3331.02 US1131 2932M-1 TUV Rheinland Job #158109 1279 Quarry Lane, Ste. A, Pleasanton, CA 95466 Tel: (925) 249-9123, Fax: (925) 249-9124 Report# 31863004.002 Page 4 of 29 Report Date: July 23, 2018 1 Executive Summary ____________________________________________________ 5 1.1 Scope _____________________________________________________________________ 5 1.2 Purpose ___________________________________________________________________ 5 1.3 Summary of Test Results _____________________________________________________ 5 1.4 Special Accessories __________________________________________________________ 5 1.5 Equipment Modifications ____________________________________________________ 5 2 Laboratory Information _________________________________________________ 6 2.1 Accreditations & Endorsements _______________________________________________ 6 2.1.1 US Federal Communications Commission __________________________________________ 6 2.1.2 NIST / A2LA ______________________________________________________________ 6 2.1.3 Canada – Industry Canada _____________________________________________________ 6 2.1.4 Japan – VCCI ______________________________________________________________ 6 2.1.5 Acceptance by Mutual Recognition Arrangement _____________________________________ 6 2.2 Test Facilities ______________________________________________________________ 7 2.2.1 Emission Test Facility ________________________________________________________ 7 2.3 Measurement Uncertainty ____________________________________________________ 8 2.3.1 Sample Calculation – radiated & conducted emissions _________________________________ 8 2.3.2 Measurement Uncertainty Emissions _____________________________________________ 8 2.4 Calibration Traceability _____________________________________________________ 9 3 Product Information ____________________________________________________ 9 3.1 Product Description _________________________________________________________ 9 3.2 Equipment Configuration ____________________________________________________ 9 3.3 Operating Mode ____________________________________________________________ 9 3.4 Unique Antenna Connector ___________________________________________________ 9 4 Operation within the band 13.110-14.010 ___________________________________ 10 4.1.1 Results__________________________________________________________________ 10 4.1.2 Restricted band Emissions ____________________________________________________ 14 4.1.3 Frequency Stability _________________________________________________________ 21 5 Test Equipment Used List _______________________________________________ 23 6 EMC Test Plan _______________________________________________________ 24 6.1 Introduction ______________________________________________________________ 24 6.2 Customer_________________________________________________________________ 24 6.3 Test Configuration _________________________________________________________ 24 6.4 Equipment Under Test (EUT) ________________________________________________ 25 6.5 Block Diagram ____________________________________________________________ 28 6.6 Test Specifications _________________________________________________________ 29 TUV Rheinland Job #158109 1279 Quarry Lane, Ste. A, Pleasanton, CA 95466 Tel: (925) 249-9123, Fax: (925) 249-9124 Report# 31863004.002 Page 5 of 29 Report Date: July 23, 2018 1 Executive Summary 1.1 Scope The purpose of the following report is to demonstrate compliance of the Freest…

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T UV Rheinland 1279 Quarry Lane, St e. A, P leasant on, CA 95466 T el: (925) 249-9123, Fax: (925) 249-9124 Document Number: 31863863.001 Page 1 of 9 EUT: Error! Reference source not found. Model: Error! Reference source not found. FCC ID: QXS-LIB02 IC ID: 12106A-LIB02 FCC Unlicensed Test Setup Photos Conducted measurements setup T UV Rheinland 1279 Quarry Lane, St e. A, P leasant on, CA 95466 T el: (925) 249-9123, Fax: (925) 249-9124 Document Number: 31863863.001 Page 2 of 9 EUT: Error! Reference source not found. Model: Error! Reference source not found. FCC ID: QXS-LIB02 IC ID: 12106A-LIB02 Power line conducted emissions setup T UV Rheinland 1279 Quarry Lane, St e. A, P leasant on, CA 95466 T el: (925) 249-9123, Fax: (925) 249-9124 Document Number: 31863863.001 Page 3 of 9 EUT: Error! Reference source not found. Model: Error! Reference source not found. FCC ID: QXS-LIB02 IC ID: 12106A-LIB02 Radiated Emissions 9k-30 MHz front T UV Rheinland 1279 Quarry Lane, St e. A, P leasant on, CA 95466 T el: (925) 249-9123, Fax: (925) 249-9124 Document Number: 31863863.001 Page 4 of 9 EUT: Error! Reference source not found. Model: Error! Reference source not found. FCC ID: QXS-LIB02 IC ID: 12106A-LIB02 Radiated Emissions 9k-30 MHz rear T UV Rheinland 1279 Quarry Lane, St e. A, P leasant on, CA 95466 T el: (925) 249-9123, Fax: (925) 249-9124 Document Number: 31863863.001 Page 5 of 9 EUT: Error! Reference source not found. Model: Error! Reference source not found. FCC ID: QXS-LIB02 IC ID: 12106A-LIB02 Radiated Emissions 30-1000 MHz front T UV Rheinland 1279 Quarry Lane, St e. A, P leasant on, CA 95466 T el: (925) 249-9123, Fax: (925) 249-9124 Document Number: 31863863.001 Page 6 of 9 EUT: Error! Reference source not found. Model: Error! Reference source not found. FCC ID: QXS-LIB02 IC ID: 12106A-LIB02 Radiated Emissions 30 to 1GHz rear T UV Rheinland 1279 Quarry Lane, St e. A, P leasant on, CA 95466 T el: (925) 249-9123, Fax: (925) 249-9124 Document Number: 31863863.001 Page 7 of 9 EUT: Error! Reference source not found. Model: Error! Reference source not found. FCC ID: QXS-LIB02 IC ID: 12106A-LIB02 Radiated Emissions 1-18 GHz front T UV Rheinland 1279 Quarry Lane, St e. A, P leasant on, CA 95466 T el: (925) 249-9123, Fax: (925) 249-9124 Document Number: 31863863.001 Page 8 of 9 EUT: Error! Reference source not found. Model: Error! Reference source not found. FCC ID: QXS-LIB02 IC ID: 12106A-LIB02 T UV Rheinland 1279 Quarry Lane, St e. A, P leasant on, CA 95466 T el: (925) 249-9123, Fax: (925) 249-9124 Document Number: 31863863.001 Page 9 of 9 EUT: Error! Reference source not found. Model: Error! Reference source not found. FCC ID: QXS-LIB02 IC ID: 12106A-LIB02 Radiated Emissions 1 to 18GHz rear Radiated Emissions 18-40 GHz front