2ANB3-DUODigital Stethoscope

User Manual DUO DUO - User Manual Pg 2 1.2 Introduction, Warnings, and Safety The Eko DUO System is designed to support healthcare professionals in analyzing cardiac and other internal organ sounds. The Eko DUO System includes a device capturing heart sounds and ECG readings (herein referred to as DUO), a smartphone application (App), and a web application (Dashboard). DUO features audio and ECG data transmission via Bluetooth that allows the user to play sounds and visualize phonocardiograms (PCG) and electrocardiograms (ECG) in a mobile application on compatible iOS and Android smartphones and tablets. The app provides the ability to save audio recordings and waveforms (PCG and ECG), share patient recordings with other practitioners, and annotate notes on recorded audio. DUO is intended for use on pediatric and adult patients. The device is not intended for infants weighing less than 10 kg. CAUTION: Federal (USA) law restricts this device to sale to or on the order of a licensed medical professional. 1.1 Indications for Use The Eko DUO System is intended to be used by healthcare professionals to electronically amplify, filter, and transfer body sounds and single-channel electrocardiogram (ECG) waveforms. The Eko DUO System also displays ECG waveforms and phonocardiogram waveforms on the accompanying mobile application for storage and sharing (when prescribed or used under the care of a physician). It can be used to record heart sounds and cardiac murmurs, bruits, respiratory sounds, and abdominal sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary, or abdominal organ systems. The device can be used on adults and pediatrics. The data offered by the device is only significant when used in conjunction with physician over read as well as consideration of other relevant patient data. The device should not be used on infants weighing less than 10kg. Table of Contents 1.1 Indications for Use ....................................................pg 2 1.2 Introduction, Warnings and Safety .................pg 2 1.3 For Help and Assistance ........................................pg 3 1.4 Safety Related Labels & Symbols ....................pg 3 1.5 Caution .............................................................................pg 4 1.6 Skin Preparation .........................................................pg 5 1.7 EMC Compliance ........................................................pg 5 1.8 FCC and Industry Canada Compliance Statement ...........................................pg 5 1.9 Cleaning ...........................................................................pg 6 1.10 Precautions ....................................................................pg 6 1.11 Patient Privacy .............................................................pg 7 1.12 Contents and Operation ........................................pg 7 2.1 Setup .................................................................................pg 8 2.2 Charging ..........................................................................pg 8 3.1 Turning On and Off, Changing Filters, Taking a Recording ...................................................pg 9 3.2 LED Indicator Lights ................................................pg 10 3.3 Capturing Sounds and ECGs ..............................pg 11 4.1 Operating Conditions ............................................pg 12 5.1 Eko App Use ................................................................pg 13 6.1 Electrical Safety .................................................pg 14–16 7.1 Manufacturing and Regulatory Info ..............pg 17 DUO - User Manual Pg 3 Wireless Bluetooth communication To identify a type CF applied part complying with IEC 60601-1 Quantity MR Unsafe Requires prescription in the United States. European technical conformity Manufacturer European Authorized Representative Manufacturing date 0537 Instructions for use. Do not dispose with household waste This product and packaging does not contain natural rubber latex. Emits Radio Frequency signal Catalog Number Lot Number Serial Number Humidity range Temperature range This product is provided non-sterile. Do not attempt to re-sterilize the device. IP22 indicates protection against access to hazardous parts with a finger, solid objects ≥ 12.5mm diameter, and vertically falling water drops when enclosure tilted up to 15 degrees. 1.3 For Help and Assistance For general and product related comments, questions, or concerns, please contact Eko Devices, Inc. directly Please report any injury or adverse event to Eko using any of the contact methods below. Eko Devices, Inc. 1212 Broadway, Suite 100 Oakland, CA 94612 USA General Assistance and FAQs ekohealth.com/getstarted Direct Contact [email protected] Phone Support 1.844.356.3384 Warranty Information Eko provides a limited warranty for DUO. Please visit ekohealth.com/warranty for a full description of the warranty. Product Reference and Information www.ekohealth.com 1.4 Safety Related Labels & Symbols DUO - User Manual Pg 4 • To reduce the risk of device interference, keep DUO at least 2 meters away from all RF emitters including Wifi routers and radios when operating or charging. • To reduce the risks associated with infection follow all cleaning and disinfecting instructions included in this manual. Establish and follow a cleaning and disinfecting schedule after each use. • To reduce the risks associated with inaccurate data acquisition store and operate this device only as instructed in this manual. It is recommended that the battery be recharged within thirty minutes of the LED indicator turning red. Recharge the battery using only the wireless charging pad provided with the device. • DO NOT immerse the device in a liquid or subject it to any sterilization processes other than those described in this manual. The device is non-sterile. • To reduce the risks associated with very strong …

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Hyundai C-Tech, Inc. dba HCT America, Inc. 1726 Ringwood Avenue San Jose, CA 95131 TEL: +1.510.933.8848 || Fax: +1.510.933.8849 Page 1 of 1 05-06-2021 To: Hyundai C-Tech, Inc. dba HCT America, Inc. 1726 Ringwood Ave San Jose, CA 95131, USA Authorization Letter I, Connor Landgraf, hereby authorize Jennifer Yue to act on my behalf in all manners relating to all processes required for equipment approval. This includes report/document submittal, related correspondence, the signing of all documents relating to these matters, and any other lawful activity necessary to obtain such certification. Any act carried out by Jennifer Yue within the scope of this authorization shall have the same effect as my own. This authorization is valid until further written notice from Connor Landgraf. Sincerely, Connor Landgraf CEO Eko Devices, Inc. 1212 Broadway, Suite 100, Oakland, CA 94612, USA

Hyundai C-Tech, Inc. dba HCT America, Inc. 1726 Ringwood Avenue San Jose, CA 95131 TEL: +1.510.933.8848 || Fax: +1.510.933.8849 Page 1 of 1 04-29-2021 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD FCC Agent Authorization Letter ApplicantEko Devices, Inc. Model Name(s)DUO FCC ID2ANB3-DUO We, the undersigned, hereby authorize Hyundai C-Tech, Inc. dba HCT America Inc. to act on our behalf in all manners relating to application for equipment authorization, including signing of all documents relating to these matters. Any and all acts carried out by Hyundai C-Tech, Inc. dba HCT America Inc. on our behalf shall have the same effect as acts of our own. We, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). We recognize that we are still responsible for the terms and conditions outlined in the HCT America Client Services Agreement. This authorization is valid until further written notice from the applicant. Sincerely, Jennifer Yue Principal HW Quality Engineer Eko Devices, Inc. 1212 Broadway, Suite 100 Oakland, CA 94612, USA 04 / 29 / 2021

Hyundai C-Tech, Inc. dba HCT America, Inc. 1726 Ringwood Avenue San Jose, CA 95131 TEL: +1.510.933.8848 || Fax: +1.510.933.8849 Page 1 of 1 04-29-2021 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD FCC Request for Confidentiality We hereby request confidential treatment of information accompanying this application as outlined below: ApplicantEko Devices, Inc. Model NameDUO FCC ID2ANB3-DUO Long-Term ConfidentialityShort-Term Confidentiality Block DiagramInternal Photos SchematicsExternal Photos Operational DescriptionTest Setup Photos User’s Manual The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these materials may be harmful to the applicant and provide unjustified benefits to its competitors. The applicant understands that disclosure of this application and all accompanying documentation will not be made before the date of the Grant for this application. We would like request to hold documents listed under Short-Term Confidentiality to remain confidential up to 180 days. Sincerely, Jennifer Yue Principal HW Quality Engineer Eko Devices, Inc. 1212 Broadway, Suite 100 Oakland, CA 94612, USA 04 / 29 / 2021

1 / 4 This document may not be copied or reproduced (reprinted) without written consent by Hyundai C-Tech, Inc. dba HCT America, Inc. Hyundai C-Tech, Inc. dba HCT America, Inc., 1726 Ringwood Avenue, San Jose, CA 95131, USA. TEL: +1-510-933-8848 FAX: +1-510-933-8849 APPENDIX B.1 PHOTOGRAPHS OF EUT EXTERNAL PHOTOS Applicant Eko Devices, Inc Model Name DUO FCC ID 2ANB3-DUO IC ID 23063-DUO Reference Test Report No.: HA210325-EKO-001-R01 2 / 4 This document may not be copied or reproduced (reprinted) without written consent by Hyundai C-Tech, Inc. dba HCT America, Inc. Hyundai C-Tech, Inc. dba HCT America, Inc., 1726 Ringwood Avenue, San Jose, CA 95131, USA. TEL: +1-510-933-8848 FAX: +1-510-933-8849 Front View Rear View 3 / 4 This document may not be copied or reproduced (reprinted) without written consent by Hyundai C-Tech, Inc. dba HCT America, Inc. Hyundai C-Tech, Inc. dba HCT America, Inc., 1726 Ringwood Avenue, San Jose, CA 95131, USA. TEL: +1-510-933-8848 FAX: +1-510-933-8849 Left Side View Right Side View 4 / 4 This document may not be copied or reproduced (reprinted) without written consent by Hyundai C-Tech, Inc. dba HCT America, Inc. Hyundai C-Tech, Inc. dba HCT America, Inc., 1726 Ringwood Avenue, San Jose, CA 95131, USA. TEL: +1-510-933-8848 FAX: +1-510-933-8849 Top View Bottom View

FCC ID: 2ANB3-DUO IC: 23063-DUO XXX-ABCDEF (01)00850010298054(21)YYWWNNNNN

1 / 2 This document may not be copied or reproduced (reprinted) without written consent by Hyundai C-Tech, Inc. dba HCT America, Inc. Hyundai C-Tech, Inc. dba HCT America, Inc., 1726 Ringwood Avenue, San Jose, CA 95131, USA. TEL: +1-510-933-8848 FAX: +1-510-933-8849 APPENDIX B.2 PHOTOGRAPHS OF EUT INTERNAL PHOTOS Applicant Eko Devices, Inc Model Name DUO FCC ID 2ANB3-DUO IC ID 23063-DUO Reference Test Report No.: HA210325-EKO-001-R01 2 / 2 This document may not be copied or reproduced (reprinted) without written consent by Hyundai C-Tech, Inc. dba HCT America, Inc. Hyundai C-Tech, Inc. dba HCT America, Inc., 1726 Ringwood Avenue, San Jose, CA 95131, USA. TEL: +1-510-933-8848 FAX: +1-510-933-8849 Internal Front Internal Rear

SA R EX EM PT I O N E X H I B I T F C C APPLICANT Eko Devices, Inc. MODEL NAME DUO FCC ID 2ANB3-DUO REPORT NUMBER HA210325-EKO-001-R02 Report No.: HA210325-EKO-001-R02 1 / 7 This document may not be copied or reproduced (reprinted) without written consent by Hyundai C-Tech, Inc. dba HCT America, Inc. Hyundai C-Tech, Inc. dba HCT America, Inc., 1726 Ringwood Avenue, San Jose, CA 95131, USA TEL: +1-510-933-8848 FAX: +1-510-933-8849 T E S T R E P O R T Date of Issue May 19, 2021 Test Site Hyundai C-Tech, Inc. dba HCT America, Inc. 1726 Ringwood Ave, San Jose, CA 95131, USA Applicant Eko Devices, Inc. Applicant Address 1212 Broadway Suite 100, Oakland, CA 96412 FCC ID 2ANB3-DUO Model Name DUO EUT Type Digital Stethoscope FCC Rule Part(s) Part 2 (§2.1091) Test Procedure KDB 447498 D01 v06 The device bearing the trade name and model specified above, has been shown to comply with the applicable technical standards as indicated in the measurement report and was in accordance with the procedures specified in §2.947. The results in this report apply only to the product which was tested. Other similar equipment will not necessarily produce the same results due to production tolerance and measurement uncertainties. I attest to the accuracy of data. All measurements reported herein were performed by me or were made under my supervision and are correct to the best of my knowledge and belief. I assume full responsibility for the completeness of these measurements and vouch for the qualifications of all persons taking them. Hyundai C-Tech, Inc. dba HCT America, Inc. certifies that no party to application has been denied the FCC benefits pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C 862 Tested By Reviewed By Yongsoo Park Sunwoo Kim Test Engineer Technical Manager Report No.: HA210325-EKO-001-R02 2 / 7 This document may not be copied or reproduced (reprinted) without written consent by Hyundai C-Tech, Inc. dba HCT America, Inc. Hyundai C-Tech, Inc. dba HCT America, Inc., 1726 Ringwood Avenue, San Jose, CA 95131, USA TEL: +1-510-933-8848 FAX: +1-510-933-8849 REVISION HISTORY The revision history for this document is shown in table. TEST REPORT NO. DATE DESCRIPTION HA210325-EKO-001-R02 05/19/2021 Initial Issue Report No.: HA210325-EKO-001-R02 3 / 7 This document may not be copied or reproduced (reprinted) without written consent by Hyundai C-Tech, Inc. dba HCT America, Inc. Hyundai C-Tech, Inc. dba HCT America, Inc., 1726 Ringwood Avenue, San Jose, CA 95131, USA TEL: +1-510-933-8848 FAX: +1-510-933-8849 TABLE OF CONTENTS 1. EUT DESCRIPTION ................................................................................................................................................... 4 2. INTRODUCTION ...................................................................................................................................................... 5 2.1. LIMIT ............................................................................................................................................................ 5 3. RESULT .................................................................................................................................................................... 6 3.1. SUMMARY OF RESULTS ................................................................................................................................ 6 3.2. CONCLUSION ................................................................................................................................................ 6 Report No.: HA210325-EKO-001-R02 4 / 7 This document may not be copied or reproduced (reprinted) without written consent by Hyundai C-Tech, Inc. dba HCT America, Inc. Hyundai C-Tech, Inc. dba HCT America, Inc., 1726 Ringwood Avenue, San Jose, CA 95131, USA TEL: +1-510-933-8848 FAX: +1-510-933-8849 1. EUT DESCRIPTION Model DUO EUT Type Digital Stethoscope Power Supply 3.7 VDC Li-ion Rechargeable Battery (550 mAh, 2.04 Wh) RF Specification Bluetooth LE V4.2 (1Mbps) Frequency Range 2402 MHz - 2480 MHz Max. RF Output Power Max tune up power including the tolerance : 3 dBm Modulation Type GFSK Number of Channels 40 Channels Antenna Specification 1) Antenna Type : Stamped-metal Inverted-F Antenna Peak Gain : 4.83 dBi Transmitter Chain 1 Operating Environment 2) Indoor and outdoor Operating Temperature 2) +10 °C ~ +45 °C Note : 1. Antenna information is based on the document provided. 2. Environmental operating condition is declared by the manufacturer. Report No.: HA210325-EKO-001-R02 5 / 7 This document may not be copied or reproduced (reprinted) without written consent by Hyundai C-Tech, Inc. dba HCT America, Inc. Hyundai C-Tech, Inc. dba HCT America, Inc., 1726 Ringwood Avenue, San Jose, CA 95131, USA TEL: +1-510-933-8848 FAX: +1-510-933-8849 2. INTRODUCTION 2.1. LIMIT The RF exposure from potable device, as defined by FCC, must be evaluated with respect to FCC-adopted limits for SAR in accordance with 47 CFR §2.1091. If no other RF exposure testing or reporting are required, a statement of justification and compliance must be included in the equipment approval, in lieu of the SAR report, to qualify for SAR test exclusion. SAR Test Exclusion Thresholds for 100 MHz – 6 GHz and ≤ 50 mm Approximate SAR Test Exclusion Power Thresholds at Selected Frequencies and Test Separation Distances are illustrated in the following Table, Appendix A, KDB 447498 D01 v06, ‘General RF Exposure Guidance’. MHz 5 10 15 20 25 30 35 40 45 50 mm 150 39 77 116 155 194 232 271 310 349 387 SAR Test Exclusion Threshold (mW) 300 27 55 82 110 137 164 192 219 246 274 450 22 45 67 89 112 134 157 179 201 224 835 16 33 49 66 82 98 115 131 148 164 900 16 32 47 63 79 95 111 126 142 158 1500 12 24 37 49 61 73 86 98 110 122 1900 11 22 33 44 54 65 76 87 98 109 2450 10 19 29 38 48 57 67 77 86 96 3600 8 16 24 32 40 47 55 63 71 79 5200 7 13 20 26 33 39 46 53 59 66 5400 6 13 19 26 32 39 45 52 58 65 5800 6 12 19 25 31 37 44 50 56 …

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RF TEST REPORT F C C / I S E D APPLICANT Eko Devices, Inc. MODEL NAME DUO FCC ID 2ANB3-DUO ISED ID 23063-DUO REPORT NUMBER HA210325-EKO-001-R01 Report No.: HA210325-EKO-001-R01 1 / 44 This document may not be copied or reproduced (reprinted) without written consent by Hyundai C-Tech, Inc. dba HCT America, Inc. Hyundai C-Tech, Inc. dba HCT America, Inc., 1726 Ringwood Avenue, San Jose, CA 95131, USA TEL: +1-510-933-8848 FAX: +1-510-933-8849 T E S T R E P O R T Date of Issue May 19, 2021 Test Site Hyundai C-Tech, Inc. dba HCT America, Inc. 1726 Ringwood Ave, San Jose, CA 95131, USA Applicant Eko Devices, Inc. Applicant Address 1212 Broadway Suite 100, Oakland, CA 96412 FCC ID 2ANB3-DUO ISED ID 23063-DUO Model Name DUO EUT Type Digital Stethoscope Modulation Type GFSK FCC Classification Digital Transmission System (DTS) FCC Rule Part(s) Part 15.247 ISED Rule Part(s) RSS-247 Issue 2 (February 2017), RSS-Gen Issue 5 (April 2018) Test Procedure ANSI C63.10-2013, KDB 558074 D01 v05r02 The device bearing the trade name and model specified above, has been shown to comply with the applicable technical standards as indicated in the measurement report and was tested in accordance with the measurement procedures required. The results of testing in this report apply only to the product which was tested. Other similar equipment will not necessarily produce the same results due to production tolerance and measurement uncertainties. I attest to the accuracy of data. All measurements reported herein were performed by me or were made under my supervision and are correct to the best of my knowledge and belief. I assume full responsibility for the completeness of these measurements and vouch for the qualifications of all persons taking them. Hyundai C-Tech, Inc. dba HCT America, Inc. certifies that no party to application has been denied the FCC benefits pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C 862 Tested By Reviewed By Yongsoo Park Sunwoo Kim Test Engineer Technical Manager Report No.: HA210325-EKO-001-R01 2 / 44 This document may not be copied or reproduced (reprinted) without written consent by Hyundai C-Tech, Inc. dba HCT America, Inc. Hyundai C-Tech, Inc. dba HCT America, Inc., 1726 Ringwood Avenue, San Jose, CA 95131, USA TEL: +1-510-933-8848 FAX: +1-510-933-8849 REVISION HISTORY The revision history for this document is shown in table. TEST REPORT NO. DATE DESCRIPTION HA210325-EKO-001-R01 05/19/2021 Initial Issue Report No.: HA210325-EKO-001-R01 3 / 44 This document may not be copied or reproduced (reprinted) without written consent by Hyundai C-Tech, Inc. dba HCT America, Inc. Hyundai C-Tech, Inc. dba HCT America, Inc., 1726 Ringwood Avenue, San Jose, CA 95131, USA TEL: +1-510-933-8848 FAX: +1-510-933-8849 TABLE OF CONTENTS 1. GENERAL INFORMATION ......................................................................................................................................... 4 2. METHODOLOGY ...................................................................................................................................................... 6 3. INSTRUMENT CALIBRATION .................................................................................................................................... 6 4. FACILITIES AND ACCREDITATIONS............................................................................................................................ 7 5. ANTENNA REQUIREMENTS ..................................................................................................................................... 8 6. MEASUREMENT UNCERTAINTY ............................................................................................................................... 9 7. DESCRIPTION OF TESTS ..........................................................................................................................................10 8. SUMMARY OF TEST RESULTS ..................................................................................................................................22 9. TEST RESULT ...........................................................................................................................................................25 9.1. DUTY CYCLE .................................................................................................................................................25 9.2. 6 dB BANDWIDTH / 99% BANDWIDTH MEASUREMENT ...............................................................................26 9.3. OUTPUT POWER ..........................................................................................................................................28 9.4. POWER SPECTRAL DENSITY .........................................................................................................................30 9.5. CONDUCTED BAND EDGE & SPURIOUS EMISSIONS .....................................................................................31 9.6. RADIATED SPURIOUS EMISSIONS ................................................................................................................33 9.7. RADIATED RESTRICTED BAND EDGES ...........................................................................................................38 9.8. RECEIVER SPURIOUS EMISSION ...................................................................................................................39 10. LIST OF TEST EQUIPMENT.....................................................................................................................................41 APPENDIX A. TEST SETUP PHOTOS .............................................................................................................................42 APPENDIX B. PHOTOGRAPHS OF EUT .........................................................................................................................43 Report No.: HA210325-EKO-001-R01 4 / 44 This document may not be copied or reproduced …

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Test Report No.: HA210325-EKO-001-R01 APPEXDIX A 1 / 4 This document may not be copied or reproduced (reprinted) without written consent by Hyundai C-Tech, Inc. dba HCT America, Inc. Hyundai C-Tech, Inc. dba HCT America, Inc., 1726 Ringwood Avenue, San Jose, CA 95131, USA. TEL: +1-510-933-8848 FAX: +1-510-933-8849 APPENDIX A TEST SETUP PHOTOS Applicant Eko Devices, Inc Model Name DUO FCC ID 2ANB3-DUO IC ID 23063-DUO Reference Test Report No.: HA210325-EKO-001-R01 Test Report No.: HA210325-EKO-001-R01 APPEXDIX A 2 / 4 This document may not be copied or reproduced (reprinted) without written consent by Hyundai C-Tech, Inc. dba HCT America, Inc. Hyundai C-Tech, Inc. dba HCT America, Inc., 1726 Ringwood Avenue, San Jose, CA 95131, USA. TEL: +1-510-933-8848 FAX: +1-510-933-8849 Radiated Emission Test Setup : Below 1 GHz 9 kHz – 30 MHz 30 MHz – 1 GHz Test Report No.: HA210325-EKO-001-R01 APPEXDIX A 3 / 4 This document may not be copied or reproduced (reprinted) without written consent by Hyundai C-Tech, Inc. dba HCT America, Inc. Hyundai C-Tech, Inc. dba HCT America, Inc., 1726 Ringwood Avenue, San Jose, CA 95131, USA. TEL: +1-510-933-8848 FAX: +1-510-933-8849 Radiated Emission Test Setup : Above 1 GHz 1 GHz – 18 GHz 18 GHz -25 GHz Test Report No.: HA210325-EKO-001-R01 APPEXDIX A 4 / 4 This document may not be copied or reproduced (reprinted) without written consent by Hyundai C-Tech, Inc. dba HCT America, Inc. Hyundai C-Tech, Inc. dba HCT America, Inc., 1726 Ringwood Avenue, San Jose, CA 95131, USA. TEL: +1-510-933-8848 FAX: +1-510-933-8849 RF Conducted Test Setup RF Conducted Test