2A7VI-ACCV3AccuSom

IFU – AccuSom V3 HST Rev A OPERATORS MANUAL FOR ACCUSOM Applicable to reference 1017-10001-US 2 3 Table of Contents 1 Foreword .................................................................................................................................... 5 1.1 Intended use ............................................................................................................................... 5 1.2 Indications for use ...................................................................................................................... 5 1.3 Scope .......................................................................................................................................... 5 1.4 Document History ....................................................................................................................... 5 1.5 Glossary ...................................................................................................................................... 6 1.6 Symbology .................................................................................................................................. 6 2 Introduction ................................................................................................................................ 7 2.1 Prerequisites ............................................................................................................................... 7 2.2 Cautions and Warning ................................................................................................................ 7 2.3 Contraindications ....................................................................................................................... 7 3 System Overview ........................................................................................................................ 7 3.1 Chest Unit ................................................................................................................................... 8 3.2 Chest Sensor ............................................................................................................................... 8 3.3 Breath Sensor ............................................................................................................................. 9 3.4 Finger sensor ............................................................................................................................ 10 3.4.1 Compatible finger sensors ........................................................................................................ 10 3.5 Charging the AccuSom .............................................................................................................. 11 4 Performing a Sleep Study with AccuSom ................................................................................. 12 4.1 Before you start ........................................................................................................................ 12 4.2 How to get the AccuSom App ................................................................................................... 12 4.3 Starting a new study ................................................................................................................. 13 4.3.1 Study with smartphone application ......................................................................................... 13 4.3.2 Study without Smartphone application. .................................................................................. 14 4.4 Recorder Light status ................................................................................................................ 15 5 Safety information .................................................................................................................... 16 5.1 Operating condition .................................................................................................................. 16 5.2 Technical Specifications ............................................................................................................ 16 5.3 Safety information .................................................................................................................... 18 5.4 Information on Residual Risks .................................................................................................. 19 5.5 Information on Wireless technology ........................................................................................ 19 5.6 Information on Electromagnetic Compatibility ........................................................................ 20 5.7. Risks linked to using the device ................................................................................................ 23 5.6.1 Risks of Electric Shock to patient .............................................................................................. 23 4 5.6.2 Risks Associated with Battery & Charger ................................................................................. 23 5.6.3 Risks Associated with RF exposure in order to limit any potential hazard of user thermal injury, tissue damage: .......................................................................................................................... 23 5.6.4 Risks Associated with errors in measurement/diagnosis ......................................................... 23 5.6.5 Risks associated with human errors ......................................................................................... 24 5.6.6 Risks associated with chest sensor ........................................................................................... 24 5.6.7 Risks associated with breath sensor ......................................................................................... 24 6 Regulatory information ............................................................................................................ 25 6.1 System Life Cycle ....................…

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Form: RFT-AMER-TCB-OP-19m Revision: 1 Page 1 of 1 Date: 12/08/2022 BioSerenity USA, Inc. Attention: Application Examiner Re: Covered List, located at https://www.fcc.gov/supplychain/coveredlist and Report & Order 22-84 located at https://docs.fcc.gov/public/attachments/DOC-389524A1.pdf Applicant: [BioSerenity USA, Inc.] FCC ID: [2A7VI-ACCV3] To whom it may concern, Pursuant to FCC Report & Order 22-84 section IV. Interim Freeze Order, paragraphs 264, 265, and 266, as an authorized representative of [BioSerenity USA, Inc.], I attest that the equipment for which we are seeking equipment authorization through certification is not prohibited from receiving an equipment authorization; and [BioSerenity USA, Inc.] is not an entity identified on the Covered List or an affiliate or subsidiary of an entity identified on the Covered List, established pursuant to 47 CFR §1.50002. I HEREBY CERTIFY THAT I am authorized to make the representations above on behalf of the company and agree to immediately notify Intertek if there is any change in the status identified above. [Madubuike OKAFOR] [Director of QMS & Regulatory Affairs for US Medical Devices] [BioSerenity USA, Inc.]

[7/19/2022] Federal Communications Commission 445 12 th Street SW Washington, DC 20554 Subject: Limited Agency Agreement BioSerenity USA, Inc. FCC ID: 2A7VI-ACCV3 To Whom It May Concern: We, BioSerenity USA, Inc., hereby authorized Intertek Testing Services Shenzhen Ltd. Guangzhou Branch to act as our Agent for the purpose of preparing application for FCC ID number 2A7VI-ACCV3 under all applicable parts of the FCC rules and regulations. The effective date of this limited agency agreement is July 19 th , 2022. The Limited Agency Agreement expires on January 31 st , 2023, unless sooner terminated or extended by written notice to Intertek Testing Services Shenzhen Ltd. Guangzhou Branch and the Federal Communications Commission. This is to advise that we are in full compliance with the Anti-Drug Abuse Act. The applicant is not subject to a denial of federal benefits pursuant to Section 5301 of the Anti-Drug Act of 1988, 21 U.S.C. 862, and no party to the application is subject to a denial of federal benefits pursuant to that section. If you have any questions or comments, please do not hesitate to contact me. Sincerely, Madubuike OKAFOR Director of QMS & Regulatory Affairs for US Medical Devices

1(1) 8/25/2022 Attention: Application Examiner RE: Request for Confidentiality Applicant: BioSerenity USA, Inc. FCC ID: 2A7VI-ACCV3 To Whom It May Concern: Permanent Confidentiality Request is hereby submitted by BioSerenity USA, Inc. to withhold permanently from public review certain portions of the application for equipment certification for the referenced FCC identifiers. This request for confidentiality is made pursuant to 47 CFR 0.457(d) and 0.459 of the FCC Rules. In particular, the following sections of the application are to be kept permanently confidential: • Schematics • Detailed Block Diagrams • Detailed Operational/Functional Description Rationale for request for confidentiality: BioSerenity USA, Inc. has invested considerable time and materials in research and development to produce the referenced product. Disclosure of the permanently confidential portions of this application to competitors would not only give them significant competitive advantages in developing similar products, but would also disclose successful implementation of unpublished, leading-edge technology developed by us. If you have questions or need further information, please contact the undersigned. Sincerely, Madubuike OKAFOR Director of QMS & Regulatory Affairs for US Medical Devices BioSerenity USA, Inc.

FCC ID Label

Intertek Testing Services Shenzhen Ltd. Guangzhou Branch Room 02, & 101/E201/E301/E401/E501/E601/E701/E801 of Room 01 1-8/F., No. 7-2. Caipin Road, Science City, GETDD, Guangzhou, Guangdong, China Job No.: 220613080GZU FCC ID: 2A7VI-ACCV3 Version: 08 July 2020 Page 1 of 1 FCC RF Exposure-Portable RF Exposure Compliance Requirement Model no.: V3 The product belongs to standalone portable device base the FCC rule part 2.1091&2.1093. The transmission frequencies of the device are between 100 MHz and 6 GHz. The worst case test separation distance is 5mm. The Max Conducted Output Power and SAR Test Exclusion Threshold (mW) are listed below: Transmit frequency (GHz) Max Conducted Output Power (mW) SAR Test Exclusion Threshold (mW) 2.402-2480 0.00208 9.5 The SAR Test Exclusion Threshold is calculated from: [(max. power of channel, including tune-up tolerance, mW)/(min. test separation distance, mm)] ·[√f(GHz)] ≤ 3.0 for 1-g SAR ⚫ f(GHz) is the RF channel transmit frequency in GHz ⚫ Power and distance are rounded to the nearest mW and mm before calculation17 ⚫ The result is rounded to one decimal place for comparison According to SAR Exclusion Threshold in KDB 447498 (D01) General RF Exposure Guidance v06, the SAR report is not required. Test Location: Intertek Testing Services Shenzhen Ltd. Guangzhou Branch All tests were performed at: Room102/104, No 203, KeZhu Road, Science City, GETDD Guangzhou, China

BioSerenity USA, Inc. TEST REPORT SCOPE OF WORK EMC TESTING–V3 REPORT NUMBER 220613080GZU-001 ISSUE DATE [REVISED DATE] 29-December-2022 [--------------------] PAGES 37 DOCUMENT CONTROL NUMBER FCC BT 4.0-f © 2017 INTERTEK TEST REPORT Room 02, & 101/E201/E301/ E401/E501/E601/E701/E801 of Room 01 1-8/F., No. 7-2. Caipin Road, Science City, GETDD, Guangzhou, Guangdong, China Telephone: +86 20 8213 9688 Facsimile: +86 20 3205 7538 www.intertek.com.cn This report is for the exclusive use of Intertek's Client and is provided pursuant to the agreement between Intertek and its Client. Intertek's responsibility and liability are limited to the terms and conditions of the agreement. Intertek assumes no liability to any party, other than to the Client in accordance with the agreement, for any loss, expense or damage occasioned by the use of this report. Only the Client is authorized to permit copying or distribution of this report and then only in its entirety. Any use of the Intertek name or one of its marks for the sale or advertisement of the tested material, product or service must first be approved in writing by Intertek. The observations and test results in this report are relevant only to the sample tested. This report by itself does not imply that the material, product, or service is or has ever been under an Intertek certification program. Intertek Testing Services Shenzhen Ltd. Guangzhou Branch Room 02, & 101/E201/E301/E401/E501/E601/E701/E801 of Room 01 1-8/F., No. 7-2. Caipin Road, Science City, GETDD, Guangzhou, Guangdong, China Version: 14 December 2022 Page 2 of 37 FCC BT 4.0-f Applicant Name & Address : BioSerenity USA, Inc. 801 Cromwell Park Drive Suite 108 Glen Burnie Maryland United States Manufacturing Site : Same as applicant Intertek Report No: FCC ID: 220613080GZU-001 2A7VI-ACCV3 Test standards 47 CFR PART 15 Subpart C: 2021 section 15.247 Sample Description Product : AccuSom Model No. : V3 Electrical Rating : Li-Ion Polymer 3.7V 1800 mAh , DC5V Serial No. : Not Labeled Date Received : 13 June 2022 Date Test Conducted : 16 November 2022 to 20 November 2022 Prepared and Checked By Elena Lei Engineer Approved By: Dean Liu Project Engineer TEST REPORT Intertek Report No.: 220613080GZU-001 Version: 14 December 2022 Page 3 of 37 FCC BT 4.0-f CONTENT TEST REPORT ........................................................................................................................... 1 CONTENT ............................................................................................................................. 3 1.0 TEST RESULT SUMMARY ............................................................................................ 4 2.0 GENERAL DESCRIPTION .............................................................................................. 5 2.1 PRODUCT DESCRIPTION ........................................................................................................ 5 2.2 RELATED SUBMITTAL(S) GRANTS ............................................................................................ 6 2.3 TEST METHODOLOGY ........................................................................................................... 6 2.4 TEST FACILITY ...................................................................................................................... 6 3.0 SYSTEM TEST CONFIGURATION .................................................................................. 6 3.1 JUSTIFICATION ..................................................................................................................... 6 3.2 EUT EXERCISING SOFTWARE.................................................................................................. 7 3.3 SPECIAL ACCESSORIES ........................................................................................................... 7 3.4 MEASUREMENT UNCERTAINTY ............................................................................................... 8 3.5 EQUIPMENT MODIFICATION .................................................................................................. 8 3.6 SUPPORT EQUIPMENT LIST AND DESCRIPTION .......................................................................... 8 4.0 MEASUREMENT RESULTS ......................................................................................... 10 4.1 ANTENNA REQUIREMENT .................................................................................................... 10 4.2 6 DB BANDWIDTH (DTS BANDWIDTH) .................................................................................. 11 4.3 MAXIMUM PEAK CONDUCTED OUTPUT POWER ..................................................................... 14 4.4 PEAK POWER SPECTRAL DENSITY .......................................................................................... 17 4.5 OUT OF BAND CONDUCTED EMISSIONS ................................................................................. 20 4.6 OUT OF BAND RADIATED EMISSIONS .................................................................................... 24 4.7 RADIATED EMISSIONS IN RESTRICTED BANDS .......................................................................... 24 4.8 BAND EDGES REQUIREMENT ................................................................................................ 34 4.9 CONDUCTED EMISSION TEST ................................................................................................ 36 5.0 TEST EQUIPMENT LIST ............................................................................................. 37 TEST REPORT Intertek Report No.: 220613080GZU-001 Version: 14 December 2022 Page 4 of 37 FCC BT 4.0-f 1.0 TEST RESULT SUMMARY Test Item Test Requirement Test Method Result Antenna Requirement FCC PART 15 C section 15.247 (c) and Section 15.203 FCC PART 15 C section 15.247 (c) and Section 15.203 PASS 6 dB Bandwidth (DTS bandwidth) FCC PART 15 C section 15.247 (a)(2) ANSI C63.10: Clause 11.8 PASS Maximum Peak Conducted Outpu…

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OTA TEST REPORT Applicant Espressif Systems Product ESP ANT B Model ESP ANT B Report No. Y1806A0621-T1V3 Issue Date November 1, 2021 TA Technology (Shanghai) Co., Ltd. tested the above equipment in accordance with the requirements in ANSI/IEEE Std 149-2008. The test results show that the equipment tested is capable of demonstrating compliance with the requirements as documented in this report. Prepared by: Peng Tao Approved by: Kai Xu TA Technology (Shanghai) Co., Ltd. No.145, Jintang Rd, Tangzhen Industry Park, Pudong Shanghai, China TEL: +86-021-50791141/2/3 FAX: +86-021-50791141/2/3-8000 OTA Test Report Report No: Y1806A0621-T1V3 TA Technology (Shanghai) Co., Ltd. TA-MB-04-008O P age 2 of 14 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. TABLE OF CONTENTS 1. General Information................................................................................................ ....................... 3 1.1. Notes of the Test Report................................................................................................ ... 3 1.2. Testing laboratory................................................................................................ .............. 3 1.3. Laboratory Environment................................................................................................ .... 3 2. General Description of Equipment under Test................................................................ ............... 4 2.1. Applicant Information................................................................................................ ......... 4 2.2. Manufacturer Information................................................................................................ .. 4 2.3. Information of EUT................................................................................................ ............ 4 2.4. Test Date................................................................................................ ........................... 4 2.5. Applied Standards................................................................................................ ............. 5 3. Test Conditions................................................................................................ .............................. 6 3.1. Test Configuration................................................................................................ ............. 6 3.2. Test Measurement................................................................................................ ............. 6 4. Test Results................................................................................................................................ ... 7 4.1. Gain and Efficiency................................................................................................ ............ 7 4.2. Voltage Standing Wave Ratio (VSWR)................................................................ .............. 8 4.3. Antenna S11................................................................................................ ...................... 9 5. Test Equipment List ..................................................................................................................... 10 APPENDIX A: 2-D Pattern Plots ............................................................................................................. 11 APPENDIX B: The EUT Appearance and Test Configuration ............................................................. 13 B.1 EUT Appearance ................................................................................................................. 13 B.2 Test Configuration .............................................................................................................. 14 OTA Test Report Report No: Y1806A0621-T1V3 TA Technology (Shanghai) Co., Ltd. TA-MB-04-008O P age 3 of 14 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. 1. General Information 1.1. Notes of the Test Report This report shall not be reproduced in full or partial, without the written approval of TA technology (shanghai) co., Ltd.The results documented in this report apply only to the tested sample, under the conditions and modes of operation as described herein .Measurement Uncertainties were not taken into account and are published for informational purposes only. This report is written to support regulatory compliance of the applicable standards stated above. This report must not be used by the client to claim product certification, approval, or endorsement by any government agencies. 1.2. Testing laboratory Company: TA Technology (Shanghai) Co., Ltd. Address: No.145, Jintang Rd, Tangzhen Industry Park, Pudong City: Shanghai Post code: 201201 Country: P. R. China Contact: Xu Kai Telephone: +86-021-50791141/2/3 Fax: +86-021-50791141/2/3-8000 Website: http://www.ta-shanghai.com E-mail: [email protected] 1.3. Laboratory Environment Temperature Min. =19°C，Max. = 25°C Relative humidity Min. =40%，Max. =72% Shield effect 0.7-6GHz > 100dB Ground resistance <0.5Ω OTA Test Report Report No: Y1806A0621-T1V3 TA Technology (Shanghai) Co., Ltd. TA-MB-04-008O P age 4 of 14 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. 2. General Description of Equipment under Test 2.1. Applicant Information Company: Espressif Systems Address: #101, Block 2, 690 Bibo Road, Zhang Jiang High-Tech Park, Shanghai, China 2.2. Manufacturer Information Company: Espressif Systems Address: #101, Block 2, 690 Bibo Road, Zhang Jiang High-Tech Park, Shanghai, China 2.3. Information of EUT General information EUT Description Product Name: ESP ANT B Model ESP ANT B HW Version: / SW Version: / Antenna Type: Fixed Antenna Antenna Manufacturer: Espressif Systems Test Frequency: 2400MHz ~ 2500MHz Test lab. of the antenna gain and rad…

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Note:EUT is positioned at the center of the turntable to keep 3 m between the measurement antenna and EUT for the radiated emissions measurements Radiated Emission (30MHz-1000MHz) Radiated Emission (Above 1000MHz)