2ASE7-BIOST03020BioButton-C

Version: BBN-LBL-IFU-FULL Rev. 0.51 BioButton TM Instructions for Use AUGUST 2020 Indications for Use The BioButton TM system is a remote patient monitoring system that is capable of, through a wearable sensor device, continuously obtaining physiological data from patients in both healthcare settings and in-home settings for up to 90 days. The physiological data collected by the BioButton can include: • Heart rate at rest • Respiratory rate at rest • Skin temperature There are other non-medical data to be collected and reported by the device, including: • Activity Level • Body position • Sleep Tracking • Contact Tracing The device is capable of remote transferring of obtained physiological data from the patient’s location to clinicians patients for storage, analysis, and review. The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor, to provide physiological information. The data from the BioButton System is intended for use by healthcare professionals as an aid to diagnosis and treatment. The device is not intended for use on critical care patients. Table of Contents 1 Indications for Use 2 BioButton Overview 2 Package Contents 3 Warnings and Precautions 4 Use Instructions 5 Replace Your Adhesive 5 Troubleshooting and FAQs 6 Safety and Regulatory Information 8 Technical Specifications 9 Guidance and Declaration IN CASE OF EMERGENCY, CALL 911 IMMEDIATELY Our support line is not for medical emergencies. If you believe you have an emergency, call 911. Version: BBN-LBL-IFU-FULL Rev. 0.52 BioButton Overview The BioButton wearable device is made of medical grade silicone and is adhered with a double-sided fabric adhesive. Package Contents • BioButton Device • Fabric Skirt Adhesives • Instructions for Use Version: BBN-LBL-IFU-FULL Rev. 0.53 Warnings and Precautions • Remove the BioButton prior to any defibrillation events. Clinical validation has not been performed for persons who have a defibrillator or pacemaker device. • Keep the device away from children and pets. The BioButton device may be a choking hazard and may be harmful if swallowed. • Press the BioButton’s button regularly to verify that it is working. DO NOT wear device over excessive body hair. Excessive body hair should be trimmed using only an electric trimmer, before application. DO NOT place on broken skin including wounds, sores, or abrasions. DO NOT submerge the device in morethan 3 feet of water or submerge for longer than 30 minutes at a time. Prolonged exposure to water may cause the device to loosen from the skin. DO NOT continue wearing if severe discomfort or irritation occurs. DO NOT exert excessive force, drop, modify, or attempt to take apart the device. Doing so may cause malfunction or permanent damage. DO NOT wear or use the BioButton during a magnetic resonance imaging (MRI) procedure or in a location where it will be exposed to strong electromagnetic forces. Version: BBN-LBL-IFU-FULL Rev. 0.54 Use Instructions BEFORE YOU START a. Download and install the BioMobile TM app for iOS or Android phones. We support iOS 13+ and Android 9+ b. Set up BioHub TM unit by following the instructions in the BioHub box. DO NOT proceed until BioMobile app or BioHub is set up. GET STARTED 1. Press and hold the button for 2 SECONDS. Proceed when the LIGHT blinks repeatedly. 2. Locate area on UPPER LEFT CHEST, two inches below collar bone. 3. TRIM ANY BODY HAIR using only an electric trimmer and CLEANSE AREA with a warm, damp cloth. 4. Find adhesive. Peel backing from DEVICE SIDE of adhesive. 5. Place the BioButton ON the exposed adhesive. Turn over and REMOVE remaining adhesive backing. 6. ADHERE BioBioButton to chest. Apply pressure for 15 seconds You’re done! LIGHT PATTERN MEANINGS Press the BioButton’s button and confirm the light blinks 5 times. LIGHTS MEANING 4 regular blinks Actively monitoring 5 rapid blinks Worn for maximum wear time (up to 90 days) 10 rapid blinks (repeated 4 times) Not monitoring, connect to BioMobile app or BioHub to restart monitoring Solid light or no light Error detected, contact support immediately Version: BBN-LBL-IFU-FULL Rev. 0.55 Replace Your Adhesive • When no longer sticky. • If you experience redness or irritation in the placement area. REMOVE adhesive from bottom of device. Follow steps 4 through 6 to put on a new adhesive and reapply BioButton. When replacing the adhesive, it is advised to apply the device to a different location within the placement area. Troubleshooting and FAQs Can I shower or exercise with my device? Yes, the BioButton is water resistant and can be worn during showers and exercise. Do not apply any deodorant or lotion to the placement areas as it will reduce adhesion of the device to the skin. Can I swim or bathe with the BioButton? Yes, the BioButton is water resistant and will continue working as long as it is not submerged more than 3 feet or kept underwater for longer than 30 minutes at a time. Prolonged exposure to water may cause the device to loosen from the skin. I’m experiencing some skin irritation, what should I do? Minor skin irritation and itching may occur while wearing the BioButton. If a severe reaction develops (i.e. hives or blisters), discontinue wearing and immediately contact your physician. How long should I wear my device? Please wear your device for the entire monitoring period period, but no longer than 90 days. Each adhesive may be worn for up to 7 continuous days. You may replace the adhesive more often, as needed, to ensure good contact is maintained with the skin. How do I know my device is working? Press and release BioButton’s button. The device light will blink 4 times. If the device does not blink or blinks more than 4 times, please immediately contact Customer Support (see front cover). I’ve tried activating the device several times, and the light still won’t blink. What do I do? Contact Customer Support immediately (see front cover). You may be instructed to return the dev…

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Antenna Describe 1. Antenna describe 2. External view drawing Picture: Antenna Dimensions Antenna plate Monopole antenna Make name/model name MD1827/1831 Antenna gain 0dBi Frequency range 2.4GHz-2.483GHz Connector type direct Location of company name ShengHai Electronics(shenzhen)Ltd Table: Antenna Dimensions L1 3.94mm L2 2.70mm L3 5.00mm L4 2.64mm L5 2.00mm L6 4.90mm W1 0.90mm W2 0.50mm D1 0.50mm D2 1.40mm D3 1.70mm

RF_160, Issue 04 BioIntelliSense, Inc. Declaration of Authorization We Name: BioIntelliSense, Inc. Address: 570 El Camino Real #200 City: Redwood City Country: United States D eclare that: N ame Representative of agent: Daphne Liang (1) Agent Company name: SGS Compliance Certification Services Inc. Address: No.8,Jiucengling,Xinhua Dist., City: Tainan City. Country Taiwan R.O.C is authorized to apply for Certification of the following product(s ): Product description: BioButton-C Type designation: BIOST03020 Trademark: BIOBUTTON Validity/ expiry date 2020-09-20 on our behalf. D ate: 2020-08-20 Ci ty: Redwood City, CA , USA Name: Tracy Cheng Func tion: Head of Manufacturing............................... Signature: ............................... Notes: (1): Required for FCC application (2): For FCC it must be the Grantee Code “owner” or the authorized agent.

FCC, Request for non-disclosure Date: 21-Nov-2018 RF_501, Issue 8 Page 1 of 1 Company Name: BioIntelliSense, Inc. Address: 570 El Camino Real #200 City: Redwood City Country: United States To: Telefication B.V., Dept. FCC TCB Edisonstraat 12A 6902 PK ZEVENAAR Th e Netherlands Subject: Request for confidentiality FCC ID: 2ASE7-BIOST03020 Reference number: ###### Dear FCC TCB, 1. Lo ng-Term Confidentiality Pur suant to 47 CFR Section 0.459(a) & (b), we hereby requests non-disclosure and confidential treatment of the following materials submitted in support of FCC c ertification application: Bill(s) of Material Block Diagrams Operational Description Schematic Diagrams Tune-up Procedure Ab ove materials contain secrets, p roprietary and technical information, which would customarily be guarded from competitors under 47 CFR, section 0.457(d)(2). Disclosure or publication or any portion of this company confidential material to other parties could cause substantial competitive harm and provide unjustified benefits for competitors. 2. Sho rt -Term Confidentiality (STC) Pur suant to Public Notice DA 04-1705 of the Commission’s policy, in order to comply with the marketing regulations in 47 CFR §2.803 and the importation rules in 47 CFR §2.1204, a pplicant hereby requests Short-Term Confidential treatment of the following materials (See notes below): Internal Photos User’s Manual Test Set-up Photos External Photos Justification: Dat e: 2020-08-20 Name and signature of applicant: Notes: 1) A document or type of document can only have ONE type of confidentiality! 2) Short-Term confidentiality is in principle for 45 days from date of grant; it can be extended max 3 times (total time 180 days max.)! The planned date should stated in the RF731 application form. 3) FCC must be informed when marketing begins earlier. 4) Release takes place automatically thus extension must be requested in time. Telefication does not remind you of this! 5) Request for extension or for release must be received by Telefication at least 7 days before date of actual marketing or before expiration of the STC period Tracy Cheng To k eep our new product development confidential. STC : 45 days

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Page: 1 / 1 Report No.: T200807N03-MF Rev.: 00 No.8, Jiucengling, Xinhua Dist., Tainan City, Taiwan /8 t:(886-6) 5802-201 f:(886-6) 5802-202 www.sgs.com.tw www.ccsrf.com Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 90 days only. This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at http://www.sgs.com.tw/Terms-and-Conditions and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at http://www.sgs.com.tw/Terms-and-Conditions. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of client’s instruction, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced, except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. Compliance Certification Services Inc. Member of the SGS Group According to KDB 447498 section 4.3.1, the 1-g SAR test exclusion thresholds at test separation distance ≤ 50 mm are determined by: [(max. power of channel, including tune-up tolerance, mW) / (min. test separation distance, mm)] *·[f(GHz)] ≤ 3.0 The tune-up power is -0.52 dBm +/- 1.0dB, therefore the highest tune-up power is 0.48 dBm (1.12 mW) @ 2402 MHz When the minimum test separation distance is < 5 mm, a distance of 5 mm according to 5) in section 4.1 is applied to determine SAR test exclusion. So, ( (1.12 mW) / 5mm ) * ( 2.402GHz ^0.5 )= 0.3 [(max. power of channel, including tune-up tolerance, mW) / (min. test separation distance, mm)] * [f(GHz)] = 0.3 < 3.0 Therefore, standalone SAR measurements are not required for both head and body.

FCC ID: 2ASE7-BIOST03020 Page: 1 / 60 Report No.: T200807N03-RP1 Rev.: 00 No.8, Jiucengling, Xinhua Dist., Tainan City, Taiwan /8 t:(886-6) 5802-201 f:(886-6) 5802-202 www.sgs.com.tw www.ccsrf.com Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 90 days only. This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at http://www.sgs.com.tw/Terms-and-Conditions and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at http://www.sgs.com.tw/Terms-and-Conditions. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of client’s instruction, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced, except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. Compliance Certification Services Inc. Member of the SGS Group FCC 47 CFR PART 15 SUBPART C AND ANSI C63.10: 2013 TEST REPORT For BioButton-C Model: BIOST03020 Issued for BioIntelliSense Inc. 570 El Camino Real #200, Redwood City, CA 94063, USA Issued by Compliance Certification Services Inc. Tainan Lab. No.8, Jiucengling, Xinhua Dist., Tainan City, Taiwan Issued Date: September 07, 2020 Note: This report shall not be reproduced except in full, without the written approval of Compliance Certification Services Inc. Ltd. This document may be altered or revised by Compliance Certification Services Inc. personnel only, and shall be noted in the revision section of the document Page: 2 / 60 Report No.: T200807N03-RP1 Ref. No.: Rev.: 00 REVISION HISTORY Rev. Issue Date Revisions Effect Page Revised By 00 September 07, 2020 Initial Issue ALL Polly Wang 01 February 25, 2020 See the following note rev.01 ALL Gina Lin 02 February 26, 2020 See the following note rev.02 Page10 Gina Lin Note: Rev.00 Issue Date: February 13, 2020 Original Report Rev.01 Issue Date: February 25, 2020 Revise typo & Measurement Equipment & Average Power & Test Procedure. Rev.02 Issue Date: February 26, 2020 Revise Measurement Equipment. Page: 3 / 60 Report No.: T200807N03-RP1 Ref. No.: Rev.: 00 TABLE OF CONTENTS 1. TEST REPORT CERTIFICATION................................................................................ 4 2. TEST RESULT SUMMARY ......................................................................................... 5 3. EUT DESCRIPTION ..................................................................................................... 6 3.1 DESCRIPTION OF EUT & POWER ...................................................................................... 6 4. DESCRIPTION OF TEST MODES ............................................................................... 8 5. TEST METHODOLOGY ............................................................................................... 9 6. FACILITIES AND ACCREDITATIONS ........................................................................ 9 6.1 FACILITIES ............................................................................................................................ 9 6.2 EQUIPMENT .......................................................................................................................... 9 6.3 LABORATORY ACCREDITATIONS LISTINGS .................................................................... 9 6.4 TABLE OF ACCREDITATIONS AND LISTINGS ................................................................. 10 7. CALIBRATION AND UNCERTAINTY ....................................................................... 11 7.1 MEASURING INSTRUMENT CALIBRATION ...................................................................... 12 7.2 MEASUREMENT UNCERTAINTY ....................................................................................... 12 8. SETUP OF EQUIPMENT UNDER TEST ................................................................... 13 8.1 SETUP CONFIGURATION OF EUT .................................................................................... 13 8.2 SUPPORT EQUIPMENT ..................................................................................................... 14 8.3 EUT OPERATING CONDITION ........................................................................................... 15 9. APPLICABLE LIMITS AND TEST RESULTS ........................................................... 16 9.1 6dB BANDWIDTH ................................................................................................................ 16 9.2 MAXIMUM PEAK OUTPUT POWER ................................................................................... 20 9.3 DUTY CYCLE ...................................................................................................................... 26 9.4 POWER SPECTRAL DENSITY ........................................................................................... 30 9.5 CONDUCTED SPURIOUS EMISSION ................................................................................ 34 9.6 RADIATED EMISSIONS ...................................................................................................... 40 9.7 POWERLINE CONDUCTED EMISSIONS ........................................................................... 54 10. ANTENNA REQUIREMENT .................................................................................... 56 10.1 STANDARD APPLICABLE .................................…

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Page: 57 / 60 Report No.: T200807N03-RP1 Ref. No.: Rev.: 00 APPENDIX I SETUP PHOTOS RADIATED EMISSION MEASUREMENT SETUP Below 1GHz Page: 58 / 60 Report No.: T200807N03-RP1 Ref. No.: Rev.: 00 Page: 59 / 60 Report No.: T200807N03-RP1 Ref. No.: Rev.: 00 RADIATED RF MEASUREMENT SETUP Above 1GHz Page: 60 / 60 Report No.: T200807N03-RP1 Ref. No.: Rev.: 00 RF CONDUCTED SETUP