2AGUHINCAPInPen Basal Smart Cap Insulin Injector

InPen TM Basal smart cap User Guide 1 Contents Symbols in This User Guide5 Introduction7 Indications for Use8 Contraindications:8 Important Pediatric User Information8 Supported Devices9 Getting Started10 Setup Wizard10 About You10 Therapy Setup10 Long-acting Setup11 Confirm Last Long-acting Dose11 Attach Adapter12 Connect InPen Basal Smart Cap12 How it Works13 Logging Doses Manually15 Multi-part Injections16 Changing Pens16 2 Smart Device Notes17 Troubleshooting18 Notification Icons18 Common Problems and Solutions19 Support21 Handling and Storage21 Cleaning and Caring21 Important Notes22 Disposal22 Legal Information23 Apple Legal Notice23 Android Legal Notice23 About Bluetooth®23 Supplemental Information24 Essential Performance24 Applied Parts24 Declaration of Conformity25 FCC Compliance25 Warranty25 3 Product Specifications27 4 1.Symbols in This User Guide The following symbols are found on the Cap or the package labels. These symbols tell you about the proper and safe use of the Cap System. Non-ionizing Radiation Consult Instructions for Use Prescription Use Only Caution Do Not use if Package is Damaged Temperature Limitation Humidity Limitation Pressure Limitation Keep Dry Protection Against insertion of Large Objects and Dripping Water 5 Type BF Applied Part Device Meets European Council Directive 93/42/EEC Manufacturer Authorized Representative in the European Community European Union WEEE Directive 2012/19/EU Catalog number Use by date Batch code 6 2.Introduction This user guide will explain how to use your Cap and related features of the InPen Application (App) tohelp manage your long-acting insulin doses. Read it carefully before you use your Cap. For information about all other features of the InPen system, referto the InPen System User Guide. Important: You should read this manual before use– even if you have used the Cap before. Failure to follow the instructions may result in too much ortoo little insulin being administered. Do not share your Cap as infection or disease can be spread from one person to another. The Cap consists of the following: •InPen Basal smart cap •InPen Basal smart cap pen adapters (qty. 5) •Quick Start Guide If any of the parts of your Cap appear broken or damaged, DO NOT USE. Contact Customer Service by TappingSettingsfrom the Home screen and selecting Help and Supportfor a replacement. Cap is not recommended for the blind or visually impaired without the assistance of a sighted individual trained to use it. The App is a diabetes management tool that helps track your long-acting insulin doses. Key Features: •Dose reminders •Time since your last long-acting insulin dose •Intuitive display of your diabetes therapy •Display of glucose data automatically from supported CGMs and BGMs 7 •View and share therapy reports with your healthcare provider Support: •Setup wizard within the App. •User Guide links within the App •Instructional videos within the App. 3.Indications for Use The InPen Basal smart cap is a reusable electroniccap for the tracking of long-acting insulin doses for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patientage 7 and older. The Cap is compatible with Levemir®, Tresiba®, Lantus®, Basaglar®, and Toujeo® prefilled pens and communicates with the InPen app. A healthcare professional must provide patient specific dose and timing parameters to be programmed into the software prior to use. 4.Contraindications: The Cap is not intended for anyone unable or unwilling to: •Test blood glucose levels as recommended by a healthcare provider •Maintain sufficient diabetes self-care skills •Visit a healthcare provider regularly Caution: US law restricts the sale of the InPen Basal smart cap to sale by or on the order of a prescribing healthcare provider. 5.Important Pediatric User Information The following recommendations are meant to help younger patients and their caregivers manage and care for the Cap. Younger children may inadvertently play with the Cap or the App, leading to unintentional 8 logging of insulin. It is the responsibility of the healthcare provider and the caregiver to determineif the patient is Appropriate for the Cap. Do not allow small children to chew on or ingest parts, such as the pen cap and adapter components. Small parts could pose a choking hazard. If ingested or swallowed, these component pieces may cause internal injury or infection. For patients who do not self-manage their disease,the smart device should always be under the supervision of a caregiver. Inadvertent button presses may leadto unintentional dose logging or changes to therapy settings. These changes can potentially lead to hypoglycemic or hyperglycemic events which could result in serious injury or death. 6.Supported Devices The App is compatible with: •iOS 10 or later •Android 6 or later Check the Companion Medical website to make sure the App is compatible before updating your smart device. Periodically, the App needs to confirm thatit is compatible with your smart device and operating system version. You may see system messages with instructions or warnings. Make sure you have an internet connection (ensure that Wi-Fi or cellulardata is enabled) whenever possible. CAUTION: You must first pair your Cap with the App on a smart device. This will ensure that doses from your Cap are sent wirelessly to the App on your smart device. WARNING: The Bluetooth®feature of your Cap sends dose information to your smart device. To prevent 9 other people’s doses from being sent to the smart device, do not let anyone else use your Cap. TheCap is for single patient use only. Bluetooth®performance varies due to differences in phone hardware and operating systems. The App is not recommended on Jailbroken or Rooted devices. Your smart device must have enough memory storage or the InPen App will not be able to be installedor log doses. You may need to delete files or Apps from your smart device. 7.Getting Started The following st…

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Companion Medical, Inc. • 12230 World Trade Drive, Suite 100 • San Diego, CA 92128 • USA www.companionmedical.com Cover Letter April 9, 2021 Re: Authorization Letter – Authorized Individual To Whom It May Concern: I hereby appoint Mahtab Moberg to sign letters and applications for all filings with the Federal Communications Commission (FCC) on our behalf, and to receive and exchange data between our company and the agency in connection with certification for any products that our company owns or manufactures. Should you have any questions regarding this authorization, please contact me directly at (707) 495-0329 or by email at [email protected]. Sincerely, Jasper Benke Vice President, RA/QA/CA Companion Medical, Inc.

Medtronic MiniMed 18000 Devonshire St. Northridge, CA 91325 April 20, 2021 Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 Subject: Confidentiality Request Letter pertaining to the certification of FCC ID No: 2AGUHINCAP To whom it may concern, Medtronic MiniMed, Inc. (“Medtronic”) requests that the information contained in the items enumerated below pertaining to the above-referenced application be withheld from public disclosure in accordance with Commission’s Rules, 47 C.F.R. § 0.457(d) and 0.459, following grant of the application. The confidential information is embodied in circuit diagrams, detailed explanations, parts lists, block diagram, and internal photographs of a device designed for patients under the care of a medical professional. As such, this material is treated as highly confidential business information and information that could convey trade secrets pertaining to manufacturing and design techniques. The information for which confidentiality is sought is employed in the design and manufacture of medical device systems that are offered on a highly competitive basis. Customers for this equipment have a variety of competing sources of supply from both domestic and foreign suppliers. Disclosure would, in effect, give away the fruits of the labors of Medtronic’s engineering personnel, who have designed the equipment and the manufacturing processes. Disclosure would also offer competitors additional unwarranted insight into the state of product development thereby allowing such competitors an advantage that would not be available to Medtronic. The information for which confidential treatment is sought is kept confidential by Medtronic and not made available to third parties except pursuant to arrangements designed to prevent public disclosure. To the knowledge of those preparing this application, the information has not been disclosed publicly heretofore. The protection sought is narrowly drawn and pertains to certain specific implementations of the technology incorporated into the device for which certification is sought. Long-Term Confidentiality The materials set forth in the following exhibits, which are segregated from the non-confidential exhibits of the application, are the ones for which Medtronic requests Long-Term Confidentiality: - Internal Photos - Schematics - Block Diagram - Operational description - Parts List/Tune-Up Procedure Following the Equipment Authorization Confidentiality Request Procedures as described in KDB Guidance 726920 D01 of April 8 th , 2016, Internal Photos may be held Long-Term Confidential under the condition that the circuit board or internal components are not accessible to users. Medtronic MiniMed’s InPen Basal smart cap, which are the subject of this future filing, are not available to the public. The devices are regulated by the FDA and are available by prescription only by health care professionals. Devices have no screws and are sealed, opening the device is not possible without damaging the external case and internal parts. Therefore, the equipment to which this Long-Term Confidentiality request pertains satisfies this criterion. Sincerely, Mahtab Moberg Sr Manager, EMC/System Verification Engineering Medtronic MiniMed

Medtronic MiniMed 18000 Devonshire St. Northridge, CA 91325 April 13, 2021 Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 Subject: EMC test justification of FCC ID No: 2AGUHINCAP To whom it may concern, The FCC radiated emissions tests were performed using a bare PCB assembly without the plastic housing. This test condition produces worst case radiated emissions since there were no RF attenuation effects from the plastic enclosure. Real world usage of a finished InPen Basal smart cap in a plastic enclosure can be expected to produce lower radiated emissions levels than measured in the FCC test report due to additional RF attenuation from the plastic housing material. Sincerely, Martin Iwanowicz Sr. R/D Engineer Medtronic MiniMed

Medtronic MiniMed 18000 Devonshire St. Northridge, CA 91325 4/9/2021 To Whom It May Concern: We hereby delegate CKC Certification Services, LLC (CKC CS) power of attorney to act on our behalf in matters pertaining to certification of products. The actions of CKC CS shall be considered the same as our own. Sincerely, Mahtab Moberg EMC & System Verification Engineering, Sr. Manager| Design Quality Assurance

Medtronic MiniMed 18000 Devonshire St Northridge, CA 91325 April 13, 2021 Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 Subject: Explanation of relationship between Medtronic MiniMed, Inc. and Companion Medical, Inc. On September 10, 2020, Medtronic MiniMed, Inc. (“Medtronic”) acquired the privately held corporation Companion Medical, Inc., manufacturer of the InPen™ system, the U.S. FDA cleared smart insulin pen system. Upon acquisition, Medtronic began to promote and process orders for the InPen system. On January 2021, Medtronic centralized the distribution of the InPen system from its Kentucky distribution center in the United States. It will continue to do so for additional products once cleared for market, such as the InPen Basal smart cap (previously called InCap in some of the technical documents). Concurrently, Companion Medical, Inc. is the legal manufacturer of both the InPen system and the InPen Basal smart cap (once cleared) in the United States. Thus, Companion Medical, Inc. will maintain responsibility to design, validate, manufacture, and package the InPen System and the InPen Basal smart ap (once cleared) from its location in San Diego, California. Furthermore, products will continue to be marketed under the Companion Medical, Inc. brand name. Sincerely, Mahtab Moberg Sr Manager, EMC/System Verification Engineering Medtronic MiniMed

External Photos: SmartCap FCC ID: 2AGUHINCAP Top View Bottom View Front View Back View External Photos: SmartCap FCC ID: 2AGUHINCAP Side View 1 Side View 2 Side View 3 Side View 4 Note: The color of the device is dark blue. Device is not available to take the pictures. External Photos: SmartCap FCC ID: 2AGUHINCAP Color of the device:

Label ID and Label Location: SmartCap FCC ID: 2AGUHINCAP Confidential Label location: Label location Label

Choose Scandinavian trust www.nemko.com KDB 447498 D01 General RF Exposure Guidance v06 (October 23, 2015) 1. Declaration of RF exposure compliance for exemption from routine evaluation limits FCC ID: 2AGUHINCAP Model number: InCap-100BA Manufacturer: Companion Medical Inc. 4.3.1. Standalone SAR test exclusion considerations: During normal operation, user extremities can come within 20 cm of the internal antenna and therefore product is considered as “Portable”. The 1-g and 10-g SAR test exclusion thresholds for 100 MHz to 6 GHz at Test separation distances ≤ 50 mm are determined by: [(max. power of channel, including tune-up tolerance, mW) ÷ (min. test separation distance, mm)] × [ � 퐹퐹(퐺퐺퐺퐺퐺퐺)] ≤ 3.0 for 1-g SAR, and ≤ 7.5 for 10-g extremity SAR, where • F(GHz) is the RF channel transmit frequency in GHz • Power and distance are rounded to the nearest mW and mm before calculation • The result is rounded to one decimal place for comparison The test exclusions are applicable only when the minimum test separation distance is ≤ 50 mm, and for transmission frequencies between 100 MHz and 6 GHz. When the minimum test separation distance is < 5 mm, a distance of 5 mm according to section 4.1(f) is applied to determine SAR test exclusion Calculation based on the above formula: Separation Distance = 5 mm Conducted Output Power = -9.196 dBm = 0.120 mW (From Report D10429R1) Radiated Power (Assuming a worst-case antenna gain of 6dBi) = -3.196dBm= 0.48mW Frequency = 2.402 GHz Calculation = (0.48÷5)× √ 2.402 = 0.149 < 3 The calculation is below the threshold, therefore the product exempt from the SAR test requirements 2. Attestation ATTESTATION: I attest that the test report (#D10429R1 from Compatible Electronics) was reviewed by me and power data presented in this RF assessment was extracted from report D10429R1. Signature: Date: May 12, 2021 Name: Juan Gonzalez FCC SAR Exemption per KDB 447498

Report Number: D10429R1 20621 PASCAL WAY, LAKE FOREST, CALIFORNIA, 92630 • PH: (949) 587-0400 FX: (949) 587-0476 Page 1 of 25 FCC PART 15 SUBPART B & SUBPART C SECTION 15.247 RSS GEN, RSS 247 TEST REPORT For SMART CAP MODEL: INCAP-100BA FCC ID: 2AGUHINCAP Prepared for COMPANION MEDICAL INC. 12230 WORLD TRADE DRIVE, SUITE 100 SAN DIEGO, CA 92128 Prepared by: _____________________ HOWARD HUANG Approved by: ____________________ JEFF KLINGER COMPATIBLE ELECTRONICS, INC. 20621 PASCAL WAY LAKE FOREST, CA 92630 (949) 587-0400 DATE: MAY 3, 2021 REPORT APPENDICES TOTAL BODY A B C D E PAGES 25 2 2 2 11 36 78 This report shall not be reproduced, except in full, without the written approval of Compatible Electronics. Report Number: D10429R1 20621 PASCAL WAY, LAKE FOREST, CALIFORNIA, 92630 • PH: (949) 587-0400 FX: (949) 587-0476 Page 2 of 25 TABLE OF CONTENTS Section / Title PAGE GENERAL REPORT SUMMARY 4 SUMMARY OF TEST RESULTS 5 1. PURPOSE 6 1.1 Decision Rule & Risk 7 2. ADMINISTRATIVE DATA 8 2.1 Location of Testing 8 2.2 Traceability Statement 8 2.3 Cognizant Personnel 8 2.4 Date Test Sample was Received 8 2.5 Disposition of the Test Sample 8 2.6 Abbreviations and Acronyms 8 3. APPLICABLE DOCUMENTS 9 4. DESCRIPTION OF TEST CONFIGURATION 10 4.1 Description of Test Configuration - EMI 10 5. LISTS OF EUT, ACCESSORIES AND TEST EQUIPMENT 13 5.1 EUT and Accessory List 13 5.2 EMI Test Equipment 14 5.3 Test Software 14 6. TEST SITE DESCRIPTION 15 6.1 Test Facility Description 15 6.2 EUT Mounting, Bonding and Grounding 15 6.3 Facility Environmental Characteristics 15 6.4 Measurement Uncertainty 15 7. CHARACTERISTICS OF THE TRANSMITTER 16 7.1 Channel Number and Frequencies 16 7.2 Antenna 16 7.3 Software 16 8. Test Procedures 17 8.1 RF Emissions 17 8.2 DTS Bandwidth 21 8.3 Maximum Peak Conducted Output Power 21 8.4 Emissions in Non-Restricted Bands 22 8.5 RF Band Edges 23 8.6 Spectral Density Test 24 8.7 Variation of the Input Power 24 9. TEST PROCEDURE DEVIATIONS 25 10. CONCLUSIONS 25 Report Number: D10429R1 20621 PASCAL WAY, LAKE FOREST, CALIFORNIA, 92630 • PH: (949) 587-0400 FX: (949) 587-0476 Page 3 of 25 LIST OF APPENDICES APPENDIX TITLE A Laboratory Accreditations B Modifications to the EUT C Additional Models D Di agrams, Charts and Photos • Test Setup Diagrams • Antenna and Amplifier Gain Factors • Emissions Photos E Data Sheets LIST OF TABLES TABLE TITLE 1 Radiated Emissions Test Results LIST OF FIGURES FIGURE TITLE 1 Radiated Emissions 3 meter Semi-Anechoic Test Chamber 2 High Frequency Test Volume Report Number: D10429R1 20621 PASCAL WAY, LAKE FOREST, CALIFORNIA, 92630 • PH: (949) 587-0400 FX: (949) 587-0476 Page 4 of 25 GENERAL REPORT SUMMARY This electromagnetic emission report is generated by Compatible Electronics Inc., which is an independent testing and consulting firm. The test report is based on testing performed by Compatible Electronics personnel according to the measurement procedures described in the test sp ecifications given below and in the "Test Procedures" section of this report. The measurement data and conclusions appearing herein relate only to the sample tested and this report may not be reproduced in any form except in full, without the written permission of Compatible Electronics. This report must not be us ed by the client to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the U.S. government. Device Tested: Smart Cap Model: InCap-100BA S/N: 4E7324 FCC ID: 2AGUHINCAP Product Description: The InCap-100BA is a Smart Cap. (Dimensions: 3” x 1” x 1.125”) Clock Frequency: 32.768 kHz, 32 MHz Modifications : The EUT was not modified during the testing in order to comply with the specifications. Manufacturer: Companion Medical Inc. 12230 World Trade Drive, Suite 100 San Diego, CA 92128 Test Date: September 24-25, 2020 & April 29, 2021 Test Specifications Covered by Accreditation : Test Specifications: EMI requirements FCC CFR Title 47, Part 15 Subpart B, Subpart C Section 15.247 RSS GEN, RSS 247 Test Procedure: ANSI C63.4 & C63.10. Report Number: D10429R1 20621 PASCAL WAY, LAKE FOREST, CALIFORNIA, 92630 • PH: (949) 587-0400 FX: (949) 587-0476 Page 5 of 25 SUMMARY OF TEST RESULTS TEST DESCRIPTION RESULTS 1 Conducted RF Emissions, 150 kHz - 30 MHz. The EUT is battery powered, therefore this test was deemed unnecessary and thus was not performed. 2 Spurious RF Emissions, 9 kHz – 25 GHz. Complies with the limits of CFR Title 47 Part 15 Subpart B Section 15.109 & Subpart C Section 15.205, 15.209, & 15.247, RSS-210, RSS-GEN 3 Fundamental and Harmonics Emissions produced by the Intentional Radiator Complies with the limits of CFR Title 47 Part 15 Subpart C Section 15.205, 15.209, & 15.247, RSS-210, RSS-GEN 4 DTS Bandwidth Complies with the limits of CFR Title 47 Part 15 Subpart C Section 15.205, 15.209, & 15.247, RSS-210, RSS-GEN 5 Maximum Conducted Output Power Complies with the limits of CFR Title 47 Part 15 Subpart C Section 15.205, 15.209, & 15.247, RSS-210, RSS-GEN 6 RF Conducted Antenna Test Complies with the limits of CFR Title 47 Part 15 Subpart C Section 15.205, 15.209, & 15.247, RSS-210, RSS-GEN 7 Power Spectral Density from the Intentional Radiator to the Antenna Complies with the limits of CFR Title 47 Part 15 Subpart C Section 15.205, 15.209, & 15.247, RSS-210, RSS-GEN 8 Variation of Input Power The EUT is battery powered, therefore this test was deemed unnecessary and thus was not performed. Reported uncertainty is based on a standard uncertainty multiplied by a coverage factor of k=2 Report Number: D10429R1 20621 PASCAL WAY, LAKE FOREST, CALIFORNIA, 92630 • PH: (949) 587-0400 FX: (949) 587-0476 Page 6 of 25 1. PURPOSE This document is a qualification test report based on the Electromagnetic Interference (EMI) tests performed on the Smart Cap Model: InCap-100-BA. The EMI measurements were performed according to the measurement procedure described in ANSI C63.4 and C63.10. The tests were performed in order to determine whether the electrom…

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Test Setup Photos X axis Y axis Z axis