2AYNV-BTSM1URUWearable Sensor

User Guide for User Recording Unit (URU) DOC-00015 Rev.00 BresoTec Inc. | 555 Richmond St. W, Unit 407 Toronto, ON, M5V 3B1 Canada www.bresotec.com The User Recording Unit (URU) is designed to be used as part of the Patch system. The URU is a wearable sensor intended to record biological signals from the user during sleep. Cautions and Warnings for URU  Read the entire manual before using the URU.  When using consumables and accessories, please read the manufacturer’s information supplied with the products.  It is important to inspect the condition of the URU. If there are any visible defects, the URU should not be used.  It is recommended to initiate recording on the URU immediately before going to sleep.  Do not submerge the URU in liquid.  Do not modify the URU.  Excessive noise may affect the quality of the recording. When using the URU, the patient should sleep in a quiet environment to minimize the impact of the ambient noise.  Wireless communication devices might have an impact on the system. Do not place too close to the patch.  Small parts may be a choking hazard to children.  The healthcare professional is responsible for explaining to the patient the functions of the URU and how to operate it safely with the help of the patient User Guide. URU LED Light Indicators Light Description Solid GreenURU will start recording Flashing Green URU recording in progress Solid RedURU in error state Charging URU 1. Plug the data collection unit (DCU) into a wall outlet. URULEDLightIndicator User Guide for User Recording Unit (URU) DOC-00015 Rev.00 BresoTec Inc. | 555 Richmond St. W, Unit 407 Toronto, ON, M5V 3B1 Canada www.bresotec.com 2. Insert the URU to the charging dock in DCU. 3. The URU should be charged for approximately 2 hours. 4. The URU should be charged the day you wish to conduct the home sleep test. Directions for Use Note: The URU must be fully charged prior to usage. See charging instruction for URU. 1. Attach the URU on the neck. 2. Turn on the URU by pressing the button. The green LED light will turn on solid. 3. Once all components are connected, LED light on URU will flash green and eventually turn off within a minute. 4. Go to sleep. Cleaning and maintenance 1. Wipe all outer surfaces of URU using antiseptic isopropyl alcohol wipe. 2. Leave the components to dry. FCC Regulatory Statements This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference. (2) This device must accept any interference received, including interference that may cause undesired operation. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the Federal Communication Commission (FCC) rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment causes harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by doing one or more of the following measures: Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. User Guide for User Recording Unit (URU) DOC-00015 Rev.00 BresoTec Inc. | 555 Richmond St. W, Unit 407 Toronto, ON, M5V 3B1 Canada www.bresotec.com NOTE: THE GRANTEE IS NOT RESPONSIBLE FOR ANY CHANGES OR MODIFICATIONS NOT EXPRESSLY APPROVED BY THE PARTY RESPONSIBLE FOR COMPLIANCE. SUCH MODIFICATIONS COULD VOID THE USER’S AUTHORITY TO OPERATE THE EQUIPMENT. RF Exposure Warning This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. In order to avoid the possibility of exceeding the FCC radio frequency exposure limits, human proximity to the antenna must not be co-located or operating in conjunction with any other antenna or transmitter. ISED Regulatory Statements This device complies with ISED Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. Le présent appareil est conforme aux CNR d’Industrie Canada applicables aux appareils radio exempts de licence. L’exploitation est autorisée aux deux conditions suivantes : (1) l’appareil ne doit pas produire de brouillage; (2) l’appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d’en compromettre le fonctionnement. CAN ICES-3 (B)/NMB-3(B) RF Exposure Information This equipment complies with ISED RSS-102 radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or operating in conjunction with any other Ω. Storage/Environmental/ transport conditions Environmental operating conditions Temperature+5°Cto+40°C Relative Humidity 15% - 93%, non- condensing AtmosphericPressure700-1060hPa AltitudeUpto4000meters Temperature-40°Cto+70°C User Guide for User Recording Unit (URU) DOC-00015 Rev.00 BresoTec Inc. | 555 Richmond St. W, Unit 407 Toronto, ON, M5V 3B1 Canada www.bresotec.com Environmental conditions of transportation and storage before first use Relative Humidity 10% - 100%, including condensation AtmosphericPressure50-106kPa Environmental conditions of transportation and storage between uses Temperature -25°C without relative humidity control;…

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555 Richmond St. W, Suite 407 • Toronto ON, M5V 3B1, Canada Office: +1 844-276-3239 • Fax: +1 437-800-1139 • Email: [email protected] • bresotec.com Date 01/15/2021 TUV SUD America Inc. 10 Centennial Drive Peabody, MA 01960, USA Dear Sir or Madam, We, BresoTEC Inc. (555 Richmond Street West Unit 407, Toronto, Canada), hereby authorize Min Xie/TUV SUD Canada 11 Gordon Collins Drive, Gormley, ON. L0H 1G0 to act as our agent in all matters relating to applications for equipment authorization, including the signing of all documents relating to these matters. Yours sincerely, Name: Jackson Yu Title: VP of Engineering

555 Richmond St. W, Suite 407 • Toronto ON, M5V 3B1, Canada Office: +1 844-276-3239 • Fax: +1 437-800-1139 • Email: [email protected] • bresotec.com January 11, 2021 Federal Communications Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 Confidentiality Request FCC ID: 2AYNV-BTSM1URU Pursuant to Sections 0.457(d)(1)(ii) and 0.459 of the Commission’s Rules,BresoTEC Inc., hereby requests permanent confidential treatment of information accompanying this application as outlined below: Schematics Bill of Materials/Parts List Block Diagrams Operational Description BresoTEC Inc. alsohereby requests short-term confidential treatment of information accompanying this application as outlined below for a period of 180 days: Internal Photos External Photos User Manual Test Set-up Photographs The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these matters might be harmful to the Applicant and provide unjustified benefits to its competitors. The Applicant understands that pursuant to Rule 0.457(d)(1)(ii), disclosure of this Application and all accompanying materials will not be made before the date of the Grant for this Application. Yours sincerely, Name: Jackson Yu Company: BresoTEC Inc.

Report File #: 7169007644RF-000 © TÜV SÜD Canada Inc. This test report shall not be reproduced except in full, without written approval of TÜV SÜD Canada Inc. Exhibit: External Photos FCC ID: 2AYNV-BTSM1URU IC: 26577-BTSM1URU Client BresoTEC Inc. Product BTSM1US-URU Standard(s) RSS 247 Issue 2:2017 FCC Part 15 Subpart 15.247 Page 2 of 4 Report Issued: 6/1/2021 Report File #: 7169007644RF-000 © TÜV SÜD Canada Inc. This test report shall not be reproduced except in full, without written approval of TÜV SÜD Canada Inc. Figure 1 – EUT External Photo Top Client BresoTEC Inc. Product BTSM1US-URU Standard(s) RSS 247 Issue 2:2017 FCC Part 15 Subpart 15.247 Page 3 of 4 Report Issued: 6/1/2021 Report File #: 7169007644RF-000 © TÜV SÜD Canada Inc. This test report shall not be reproduced except in full, without written approval of TÜV SÜD Canada Inc. Figure 2 – EUT External Photo Back (Canada version) Client BresoTEC Inc. Product BTSM1US-URU Standard(s) RSS 247 Issue 2:2017 FCC Part 15 Subpart 15.247 Page 4 of 4 Report Issued: 6/1/2021 Report File #: 7169007644RF-000 © TÜV SÜD Canada Inc. This test report shall not be reproduced except in full, without written approval of TÜV SÜD Canada Inc. Figure 3 Figure 3– EUT External Photo Back (US version)

Report File #: 7169007644RF-000 © TÜV SÜD Canada Inc. This test report shall not be reproduced except in full, without written approval of TÜV SÜD Canada Inc. Exhibit: Sample Label FCC ID: 2AYNV-BTSM1URU IC: 26577-BTSM1URU Client BresoTEC Inc. Product BTSM1US-URU Standard(s) RSS 247 Issue 2:2017 FCC Part 15 Subpart 15.247:2016 Page 2 of 3 Report Issued: 6/1/2021 Report File #: 7169007644RF-000 © TÜV SÜD Canada Inc. This test report shall not be reproduced except in full, without written approval of TÜV SÜD Canada Inc. Sample Label - Canada Sample Label - US Client BresoTEC Inc. Product BTSM1US-URU Standard(s) RSS 247 Issue 2:2017 FCC Part 15 Subpart 15.247:2016 Page 3 of 3 Report Issued: 6/1/2021 Report File #: 7169007644RF-000 © TÜV SÜD Canada Inc. This test report shall not be reproduced except in full, without written approval of TÜV SÜD Canada Inc. Label Location

Report File #: 7169007644RF-000 © TÜV SÜD Canada Inc. This test report shall not be reproduced except in full, without written approval of TÜV SÜD Canada Inc. Exhibit: Internal Photos FCC ID: 2AYNV-BTSM1URU IC: 26577-BTSM1URU Client BresoTEC Inc. Product BTSM1US-URU Standard(s) RSS 247 Issue 2:2017 FCC Part 15 Subpart 15.247 Page 2 of 3 Report Issued: 3/16/2021 Report File #: 7169007644RF-000 © TÜV SÜD Canada Inc. This test report shall not be reproduced except in full, without written approval of TÜV SÜD Canada Inc. Figure 1 – EUT Internal Photo Top Antenna Client BresoTEC Inc. Product BTSM1US-URU Standard(s) RSS 247 Issue 2:2017 FCC Part 15 Subpart 15.247 Page 3 of 3 Report Issued: 3/16/2021 Report File #: 7169007644RF-000 © TÜV SÜD Canada Inc. This test report shall not be reproduced except in full, without written approval of TÜV SÜD Canada Inc. Figure 2 – EUT Internal Photo Bottom

Report File #: 7169007644RF-000 © TÜV SÜD Canada Inc. This test report shall not be reproduced except in full, without written approval of TÜV SÜD Canada Inc. Exhibit: RF Exposure – FCC FCC ID: 2AYNV-BTSM1URU Client BresoTEC Inc. Product BTSM1US-URU Standard(s) FCC Part 15 Subpart 15.247 FCC KDB 447498:2015 Page 2 of 2 Report Issued: 6/7/2021 Report File #: 7169007644RF-000 © TÜV SÜD Canada Inc. This test report shall not be reproduced except in full, without written approval of TÜV SÜD Canada Inc. RF Exposure – FCC The device is intended for use on body and the minimum separation distance from the radiating structure to any part of the body or extremity of a user is 7 mm. General SAR test exclusion guidance: As per FCC KDB 447498 Section 4.3.1 a), the 1-g SAR Test Exclusion Threshold for 100 MHz to 6 GHz at test separation distances ≤ 50 mm is determined by: [(max. power of channel, including tune-up tolerance, mW)/(min. test separation distance, mm)] [√f (GHz) ] ≤ 3.0 Where: f (GHz) is the RF channel transmit frequency in GHz SAR Calculations: 2402 – 2480 MHz DTS transmitter Peak conducted power was measured to be 11.43 mW. At a separation distance of 7mm, this results to: [11.43 mW / 7 mm]*[√2.480 GHz] = 2.6 ≤ 3.0 SAR Exclusion Threshold condition is met with maximum conducted power.

Registration # 6844A-3 Testing Laboratory Certificate #2955.02 R-14023, G-20072 C-14498, T-20060 Registration # CA6844 Page 1 of 93 Report Issued: 6/4/2021 Report File #: 7169007644RF-001 © TÜV SÜD Canada Inc. This test report shall not be reproduced except in full, without written approval of TÜV SÜD Canada Inc. FCC 15 247 Rev2 EMC & RF Test Report As per RSS-247 Issue 2:2017 & FCC Part 15 Subpart 15.247 Unlicensed Intentional Radiators on the BTSM1US-URU Issued by: TÜV SÜD Canada Inc. 11 Gordon Collins Dr, Gormley, ON, L0H 1G0 Canada Ph: (905) 883-7255 Testing produced for See Appendix A for full client & EUT details. Prepared by: Min Xie, Sr. Project Engineer Reviewed by: Amir Emami, Project Engineer Client BresoTEC Inc. Product BTSM1US-URU/ BTSM1CA-URU Standard(s) RSS 247 Issue 2:2017 FCC Part 15 Subpart 15.247 Page 2 of 93 Report Issued: 6/4/2021 Report File #: 7169007644RF-001 © TÜV SÜD Canada Inc. This test report shall not be reproduced except in full, without written approval of TÜV SÜD Canada Inc. Table of Contents Table of Contents ................................................................................................................... 2 Report Scope .......................................................................................................................... 3 Summary ................................................................................................................................ 4 Test Results Summary ....................................................................................................... 5 Notes, Justifications, or Deviations ................................................................................... 6 Sample Calculation(s) ........................................................................................................ 7 Applicable Standards, Specifications and Methods ............................................................... 8 Document Revision Status ..................................................................................................... 9 Definitions and Acronyms ................................................................................................... 10 Testing Facility .................................................................................................................... 11 Calibrations and Accreditations ....................................................................................... 11 Testing Environmental Conditions and Dates ................................................................. 12 Detailed Test Results Section .............................................................................................. 13 6dB Bandwidth of Digitally Modulated Systems ............................................................ 14 Maximum Conducted Power ........................................................................................... 20 Antenna Spurious Conducted Emissions ......................................................................... 26 Transmitter Spurious Radiated Emissions ....................................................................... 34 Power Spectral Density .................................................................................................... 80 Power Line Conducted Emissions ................................................................................... 85 Appendix A – EUT Summary .............................................................................................. 91 Appendix B – EUT and Test Setup Photos .......................................................................... 93 Client BresoTEC Inc. Product BTSM1US-URU/ BTSM1CA-URU Standard(s) RSS 247 Issue 2:2017 FCC Part 15 Subpart 15.247 Page 3 of 93 Report Issued: 6/4/2021 Report File #: 7169007644RF-001 © TÜV SÜD Canada Inc. This test report shall not be reproduced except in full, without written approval of TÜV SÜD Canada Inc. Report Scope This report addresses the EMC verification testing and test results of the BTSM1US-URU / BTSM1CA-URU and is herein referred to as EUT (Equipment Under Test). The EUT was tested for compliance against the following standards: RSS-247 Issue 2:2017 FCC Part 15 Subpart C 15.247 Test procedures, results, justifications, and engineering considerations, if any, follow later in this report. This report does not imply product endorsement by any government, accreditation agency, or TÜV SÜD Canada Inc. Opinions or interpretations expressed in this report, if any, are outside the scope of TÜV SÜD Canada Inc. accreditations. Any opinions expressed do not necessarily reflect the opinions of TÜV SÜD Canada Inc., unless otherwise stated. Client BresoTEC Inc. Product BTSM1US-URU/ BTSM1CA-URU Standard(s) RSS 247 Issue 2:2017 FCC Part 15 Subpart 15.247 Page 4 of 93 Report Issued: 6/4/2021 Report File #: 7169007644RF-001 © TÜV SÜD Canada Inc. This test report shall not be reproduced except in full, without written approval of TÜV SÜD Canada Inc. Summary The results contained in this report relate only to the item(s) tested. EUT: BTSM1US-URU/ BTSM1CA-URU FCC Certification #, FCC ID: 2AYNV-BTSM1URU Industry Canada Certification #, IC: 26577-BTSM1URU EUT passed all tests performed Yes Tests conducted by Min Xie Report reviewed by Amir Emami For testing dates, see "Testing Environmental Conditions and Dates". Client BresoTEC Inc. Product BTSM1US-URU/ BTSM1CA-URU Standard(s) RSS 247 Issue 2:2017 FCC Part 15 Subpart 15.247 Page 5 of 93 Report Issued: 6/4/2021 Report File #: 7169007644RF-001 © TÜV SÜD Canada Inc. This test report shall not be reproduced except in full, without written approval of TÜV SÜD Canada Inc. Test Results Summary Standard/Method Description Class/Limit Result FCC 15.203 Antenna Requirement Unique Pass See Justification FCC 15.205 RSS-GEN (Table 6) Restricted Bands for Intentional Operation QuasiPeak Average Pass FCC 15.207 RSS-GEN (Table 3) Power Line Conducted Emissions QuasiPeak Average Pass FCC …

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Report File #: 7169007644RF-000 © TÜV SÜD Canada Inc. This test report shall not be reproduced except in full, without written approval of TÜV SÜD Canada Inc. Exhibit: Test Setup Photos FCC ID: 2AYNV-BTSM1URU IC: 26577-BTSM1URU Client BresoTEC Inc. Product BTSM1US-URU Standard(s) RSS 247 Issue 2:2017 FCC Part 15 Subpart 15.247:2016 Page 2 of 9 Report Issued: 3/16/2021 Report File #: 7169007644RF-000 © TÜV SÜD Canada Inc. This test report shall not be reproduced except in full, without written approval of TÜV SÜD Canada Inc. Figure 1 ‒ Radiated Emissions Setup X-Axis Client BresoTEC Inc. Product BTSM1US-URU Standard(s) RSS 247 Issue 2:2017 FCC Part 15 Subpart 15.247:2016 Page 3 of 9 Report Issued: 3/16/2021 Report File #: 7169007644RF-000 © TÜV SÜD Canada Inc. This test report shall not be reproduced except in full, without written approval of TÜV SÜD Canada Inc. Figure 2 ‒ Radiated Emissions Setup 9kHz to 30MHz Client BresoTEC Inc. Product BTSM1US-URU Standard(s) RSS 247 Issue 2:2017 FCC Part 15 Subpart 15.247:2016 Page 4 of 9 Report Issued: 3/16/2021 Report File #: 7169007644RF-000 © TÜV SÜD Canada Inc. This test report shall not be reproduced except in full, without written approval of TÜV SÜD Canada Inc. Figure 3 ‒ Radiated Emissions Setup 30MHz to 1GHz Note: As per ANSI C63.10-2013 Clause 6.3.1, below 1GHz, the height of the EUT was set to 80cm. Above 1GHz, the height was raised to 1.5m. Client BresoTEC Inc. Product BTSM1US-URU Standard(s) RSS 247 Issue 2:2017 FCC Part 15 Subpart 15.247:2016 Page 5 of 9 Report Issued: 3/16/2021 Report File #: 7169007644RF-000 © TÜV SÜD Canada Inc. This test report shall not be reproduced except in full, without written approval of TÜV SÜD Canada Inc. Figure 4 ‒ Radiated Emissions Setup 1GHz to 6GHz Spurious Scans Note: As per ANSI C63.10-2013 Clause 6.3.1, above 1GHz, the height of the EUT was set to 1.5m. Client BresoTEC Inc. Product BTSM1US-URU Standard(s) RSS 247 Issue 2:2017 FCC Part 15 Subpart 15.247:2016 Page 6 of 9 Report Issued: 3/16/2021 Report File #: 7169007644RF-000 © TÜV SÜD Canada Inc. This test report shall not be reproduced except in full, without written approval of TÜV SÜD Canada Inc. Figure 5 ‒ Radiated Emissions Setup 6 GHz to 18 GHz Spurious Scans & Band-Edge Measurements Client BresoTEC Inc. Product BTSM1US-URU Standard(s) RSS 247 Issue 2:2017 FCC Part 15 Subpart 15.247:2016 Page 7 of 9 Report Issued: 3/16/2021 Report File #: 7169007644RF-000 © TÜV SÜD Canada Inc. This test report shall not be reproduced except in full, without written approval of TÜV SÜD Canada Inc. Figure 6 ‒ Radiated Emissions Setup 18 GHz to 26 GHz Spurious Scans Client BresoTEC Inc. Product BTSM1US-URU Standard(s) RSS 247 Issue 2:2017 FCC Part 15 Subpart 15.247:2016 Page 8 of 9 Report Issued: 3/16/2021 Report File #: 7169007644RF-000 © TÜV SÜD Canada Inc. This test report shall not be reproduced except in full, without written approval of TÜV SÜD Canada Inc. Figure 7 ‒ Antenna Port Conducted Emissions Setup Client BresoTEC Inc. Product BTSM1US-URU Standard(s) RSS 247 Issue 2:2017 FCC Part 15 Subpart 15.247:2016 Page 9 of 9 Report Issued: 3/16/2021 Report File #: 7169007644RF-000 © TÜV SÜD Canada Inc. This test report shall not be reproduced except in full, without written approval of TÜV SÜD Canada Inc. Figure 8 ‒ Conducted Emissions Setup