
Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.
The Genio® System 2.1 Participant Manual CAUTION - Investigational device. Limited by Federal (or United States) law to investigational use All rights reserved ©2022 Nyxoah SA All content in this manual, including the texts, trademarks, service marks, logos, illustrations, photos, graphics, design, etc., are the property of Nyxoah SA Nyxoah SA owns all rights with respect to any trademarks, service marks, logos, and copyrights appearing in this manual. Patented and design protected technology. Device not for sale in Europe, Australia or USA. For clinical use only. Manufacturer Information: NYXOAH SA Rue Edouard Belin, 12 1435 Mont-Saint-Guibert Belgium Email: [email protected] Phone: +32 (0)10 45 90 75 IDE Sponsor Information in the US: NYXOAH, Inc 251 Little Falls Drive Wilmington, DE 19808 United States of America Email: [email protected] Phone: 1-800 373-2605 IDE Sponsor Information in Europe: NYXOAH SA Rue Edouard Belin, 12 1435 Mont-Saint-Guibert Belgium Email: [email protected] Phone: +32 (0)10 45 90 75 IDE Sponsor Information in Australia: NYXOAH Pty Ltd 58 Gipps Street Collingwood, VIC 3066 Australia Email: [email protected] Phone: +61 3 9419 7607 Contact Information During the activation visit, please fill in the contact information below. Sleep Specialist Name: Phone Number: Implanting Hospital Name: Address: Surgeon Name: Surgeon Phone Number: Participants, Family Members or Caregivers Please be aware of the following: • You should read this manual carefully before you start using the Genio® System 2.1. If you have any questions or problems, please refer to the “Troubleshooting” section. If your questions are not addressed in this user manual, please contact your doctor. • You should always have your Participant Card with you and inform your doctor/s or any medical staff you have been implanted with the Genio® System 2.1 in the chin area. If they have any questions, doctors and medical staff can contact Nyxoah at the number provided in the sponsor information section (see page 2). • If you experience any unusual symptoms or problems related to the use of your Genio® System 2.1, please report this to your doctor at your earliest convenience. Please refer to the Contact Information section (see page 3). Table of Contents GLOSSARY ........................................................................................................................................................ 7 ABOUT THIS USER GUIDE ................................................................................................................................. 9 1 INTRODUCTION ..................................................................................................................................... 10 ABOUT SLEEP APNEA ............................................................................................................................................. 10 ABOUT YOUR GENIO® SYSTEM 2.1........................................................................................................................... 10 2 SAFETY INFORMATION .......................................................................................................................... 11 INTENDED USE ...................................................................................................................................................... 11 CONTRAINDICATIONS ............................................................................................................................................. 11 WARNINGS .......................................................................................................................................................... 11 MRI SAFETY INFORMATION ...................................................................................................................... 12 PRECAUTIONS ....................................................................................................................................................... 15 ADVERSE EVENTS .................................................................................................................................................. 17 STORAGE AND HANDLING ....................................................................................................................................... 21 3 YOUR GENIO® SYSTEM 2.1..................................................................................................................... 23 THERAPY OVERVIEW .............................................................................................................................................. 23 PATIENT KIT CONTENTS .......................................................................................................................................... 23 THE GENIO® SYSTEM 2.1 COMPONENTS ................................................................................................................... 23 INSTALLING YOUR GENIO® SYSTEM 2.1 ..................................................................................................................... 24 USING YOUR GENIO® SYSTEM ................................................................................................................................. 26 4 GENIO® SMARTPHONE APPLICATION .................................................................................................... 32 INSTALLATION ....................................................................................................................................................... 32 DAILY USE ........................................................................................................................................................... 37 APP MENU .......................................................................................................................................................... 44 5 TROUBLESHOOTING ...........................................................…
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nyxoah.com U.S. Agent Designation for Service of Process (Applicant is Both Grantee and U.S. Agent) TO: American Certification Body, Inc. 313 Park Avenue Suite 300 Falls Church, VA 22046 ATTENTION: FCC Certification – Section 2.911(d)(7) Information This letter is to confirm that the Applicant will also serve as the U.S. Agent for Service of Process as required by 47 CFR 2.911(d)(7). The Applicant acknowledges th at they must maintain an agent for no less than one year after terminating all marketing and importation OR the conclusion of any Commission-related proceeding involving the equipment. The Applicant further acknowledges their responsibility to inform the FCC whenever the Designated U.S. Agent information changes. Applicant Company name: Nyxoah, Inc. FRN #: 0032267221 Grantee Code: 2A6HG Contact Name: Seema Paliwal Street Address: 251 Little Falls Drive City/Province/Zip: Wilmington, Delaware, 19808 Telephone No: +1 978 602 6238 Email: [email protected] Applicant Signature: Date: May 1, 2023 Signed by (Printed Name/Title): Seema Paliwal, Director, Regulatory Affairs
nyxoah.com Certification Application Attestation Statements Date: May 1, 2023 American Certification Body, Inc. 313 Park Avenue Suite 300 Falls Church, VA 22046 To Whom It May Concern: Statement for 47 CFR section 2.911(d)(5)(i) Nyxoah, Inc. certifies that as of the date of the application the equipment for which authorization is sought is not “covered” equipment prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. Statement for 47 CFR section 2.911(d)(5)(ii) Nyxoah, Inc. (“the applicant”) certifies that, as of the date of the filing of this application, the applicant ☐ - is / ☒ - is not identified on the Covered List as an entity producing “covered” equipment. Thank you, By: __________________________ _____Seema Paliwal________ (Signature) (Print name) Title: _Director, Regulatory Affairs___ Company: __Nyxoah, Inc,______________ Telephone: _+1 978 602 6238_____________
nyxoah.com Authority to Act as Agent Date: May 1, 2023 American Certification Body, Inc. 313 Park Avenue Suite 300 Falls Church, VA 22046 To Whom It May Concern: We certify that we are not subject to denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862. Further, no party, as defined in 47 CFR 1.2002 (b), to the application is subject to denial of federal benefits, that includes FCC benefits. We also declare that the information provided to the FCC is true and correct to the best of our knowledge (47 CFR 2.911(d)) and we have been informed of the grantee responsibilities (47 CFR 2.909) with regard to certified equipment. Thank you, Agency Agreement Expiration Date: _____May 1, 2024_____ By: __________________________ _____Seema Paliwal________ (Signature) (Print name) Title: _Director, Regulatory Affairs___ On behalf of: __Nyxoah, Inc,______________ Telephone: _+1 978 602 6238_____________
Request for Confidentiality Date: June 19, 2023 Subject: Confidentiality Request for: 2A6HG-NX-ASM-002325 Pursuant to FCC 47 CFR 0.457(d) and 0.459 and/or IC RSP-100, Section 12.4, the applicant requests that a part of the subject application(s) be held confidential. Type of Confidentiality Requested □ Short Term ☒Permanent □ Short Term ----------------- Exhibit Block Diagrams External Photos □ Short Term □ Short Term □ Short Term □ Short Term □ Short Term □ Short Term □ Short Term ☐Permanent ☒Permanent ☒Permanent ☐Permanent ☒Permanent ---------------- ☐Permanent Internal Photos Operation Description/Theory of Operation Parts List & Placement/BOM Tune-Up Procedure Schematics Test Setup Photos User's Manual Nyxoah, Inc. has spent substantial effort in developing this product and it is one of the first of its kind in industry. Having the subject information easily available to "competition" would negate the advantage they have achieved by developing this product. Not protecting the details of the design will result in financial hardship. Permanent Confidentiality: The applicant requests the exhibits listed above as permanently confidential be permanently withheld from public review due to materials that contain trade secrets and proprietary information not customarily released to the public. Short-Term Confidentiality for FCC Applications: The applicant requests the exhibits selected above as short term confidential be withheld from public view for a period of NA 4 _ days from the date of the Grant of Equipment Authorization and prior to marketing. This is to avoid premature release of sensitive information prior to marketing or release of the product to the public. Applicant is also aware that they are responsible to notify ACB in the event information regarding the product or the product is made available to the public before the requested period has expired. ACB will then release the documents listed above for public disclosure pursuant to FCC Public Notice DA 04-1705. Short Term Confidentiality for Industry Canada Applications: Starting May 2022, ISED will recognize short term confidentiality on certain exhibits until the intended date of marketing. The applicant requests the exhibits selected above as short term confidential be withheld from public view until: NIA Sincerely, By: Seema Paliwal (Signature/Title) (Print name)
1. Scope: This document is intended for the Genio system 2.1 FCC certification process (required by the FCC). It includes the external photos of certified system components. 2. Background: Nyxoah’s Genio® system 2.1 is intended to be operated in the US hence required to be FCC certified or SDoC (self-declaration of conformity). Genio® system AC2364 is required to have the certification process. Other Genio® system 2.1 components compliance will be using the SDoC process. Component Description P.N Notes AC2364 NX-ASM-002325 N/A DP NX-ASM-000650 N/A IS NX-ASM-000660 N/A ES NX-ASM-000659 N/A CU2238 + Power supply CU P.N: NX-ASM-002330 Power Supply P.N: NX-ELC-002010 3. Photos: 3.1. AC2364 - general view
75 mm 75 mm REF: Product PN SN: According to PRO-0000015 Product identification and traceability procedure Date of Manufacture: YYYY-MM YYYY - Year of manufacture MM - Month of manufacture Notes: 1.Material: White Polyester (Digital Gloss White Polyester – 125) 2.Lamination: Clear Polypropylene (702) 3.Adhesive: PSA Permanent Acryl 4.Ink: Dyne based ink (CR5 Guthega Cyan) XXXX: Representing AC model number 2.0 For Reference Only 2.0 2.0 Document RevisionECR-ECO#Revision / Description 1.02020-018Initial release 2.0CC-0000018 Add UDI, product model number and warning in Spanish 75 mm 75 mm A B C0.1 M HOLES & THREADS PROFILES DIMENSIONS ARE IN MM. GENERAL TOLERANCES UNLESS OTHERWISE SPECIFIED: LINEAR DIMENSIONS ANGULAR 0-20 20&up 0.05 0.1 0.1 FOR UNSPESIFIED DIMENSIONS USE: MODEL AND GEOM. TOLERANCES A B C0.1 M NAMEDATE CHECKED DRAWN APPROVED THE INFORMATION CONTAINED IN THIS DRAWING IS THE SOLE PROPERTY OF Nyxoah Sa . ANY REPRODUCTION IN PART OR AS A WHOLE WITHOUT THE WRITTEN PERMISSION OF Nyxoah Sa. IS PROHIBITED. PROPRIETARY AND CONFIDENTIAL MATERIAL: FINISH: SIZE A3 REV SCALE: SHEET 1 OF 1 DRAWING No. ASSEMBLY No. 2.0 SIGNATURE 1:1 DESIGNED PROJECTION. WEIGHT: BREAK BURRS AND SHARP EDGES TITLE AC package label for IDE US CATALOG No. NX-LBL-002297 CHECKED NYXOAH, Yigal Alon 126, Tel- Aviv, Israel. Tel: 972-3-7716955 GAC-000-001304 See notes NA See notes Galia B. Galia B. N/A Yana B. Assaf L. 29-Nov-2022 29-Nov-2022 30-Nov-2022 01-Dec-2022
1. Scope: This document is intended for the Genio system 2.1 FCC certification process (required by the FCC). It includes the external photos of certified system components. 2. Background: Nyxoah’s Genio® system 2.1 is intended to be operated in the US hence required to be FCC certified or SDoC (self-declaration of conformity). Genio® system AC2364 is required to have the certification process. Other Genio® system 2.1 components compliance will be using the SDoC process. Component Description P.N Notes AC2364 NX-ASM-002325 N/A DP NX-ASM-000650 N/A IS NX-ASM-000660 N/A ES NX-ASM-000659 N/A CU2238 + Power supply CU P.N: NX-ASM-002330 Power Supply P.N: NX-ELC-002010 3. Photos: 3.1. AC2364 – Internal view
Genio® System 2.1 SAR exclusion calculation Contents 1. Purpose ......................................................................................................................................... 2 2. Scope ............................................................................................................................................. 2 3. Background ................................................................................................................................... 3 4. SAR exempt calculation ................................................................................................................. 4 1. Purpose The purpose of this document is to provide SAR exempt calculation for the Genio® System 2.1. The document applies to Genio® System 2.1 which utilizes the Genio® AC Model #2364 that integrates BLE transmitter. 2. Scope This document applies for the Genio® AC Model #2364 which is a part of the Genio® System 2.1. The detailed technical description is required for FCC certification process. Other Genio® System 2.1 components require SDoC (self-declaration of conformity) and hence not technically detailed described in this document. Genio® AC Model #2364 must comply with the FCC SAR requirement. This document provides SAR exclusion calculation to prove that the AC Model #2364 BLE transmitter comply with the FCC requirement. 3. Background 3.1. Genio Activation Chip (AC Model #2364) The Genio® 2.1 AC Model #2364 consists of integrated BLE Communication capabilities. Figure 1:Activation Chip (AC) view 3.2. AC BLE The AC communicates with the RaspberryPi based Sleep Lab application via 2.4GHz Bluetooth low energy (BLE). The AC software is based on BLE stack Version soft device (sd) s140 V7.2.0 implemented on Nordic (P.N NRF52840-QIAA) BLE microcontroller. BLE transmitter • Manufacturer – Nordic • P.N - NRF52840-QIAA BLE Antenna • Manufacturer – Yageo (PulseLarsen Antennas) • P.N - ANT3216LL00R2400A BLE Architecture • GFSK Modulation • 1Mbps bitrate • Antenna gain: 5.05dBi peak 4. SAR exempt calculation Calculating the SAR exclusion numeric threshold according to 4.3.1 a) and 4.1 f) of KDB 447498 D01: • Rounding channel max. power + tune up tol. to the nearest mW: -14.50dBm+2dB = -12.50dBm → 0.05mW → 1mW • Channel max power taken from the “NYXRAD_FCC.46250_BLE” report. • Test separation distance: 5mm • Tune up tolerance: 2dB • Frequency – related to the max. power: 2.40GHz • Calculation: 1/5*sqrt(2.40) = 0.30 → one decimal place rounding: 0.3 Conclusion: since 0.3 is less than the 3.0 numeric threshold, the Genio2.1 BLE transmitter meets SAR exclusion limit.
Hermon Laboratories Ltd. P.O. Box 23, Binyamina 3055001, Israel Tel. +972 4628 8001 Fax. +972 4628 8277 E-mail: [email protected] Page 1 of 59 Report ID: NYXRAD_FCC.46250_BLE_Rev2.docx Date of Issue: 7-Jun-23 ELECTRICAL TESTING 0839.01 TEST REPORT ACCORDING TO: FCC 47CFR part 15 subpart C §15.247 (DTS), RSS-247 Issue 2:2017, RSS-Gen Issue 5 FOR: Nyxoah Ltd. Genio® System 2.1 parts • Activation Chip – AC2364, PN: NX-ASM-002325 FCC ID: 2A6HG-NX-ASM-002325 • Implantable Stimulator – IS, PN: NX-ASM-000660 • Disposable Patch – DP, PN: NX-ASM-000650 • Charging Unit – CU2238+Power supply, CU PN: NX-ASM-002330, Power Supply PN: NX-ELC-002010 • External device - Raspberry-Pi mini-computer (Repeater) with Genio sleep lab app, PN: NX-ELC-002470; RaspberryPi model 3B+ (red and white or grey color of cover) This report is in conformity with ISO/ IEC 17025. The "A2LA Accredited" symbol endorsement applies only to the tests and calibrations that are listed in the scope of Hermon Laboratories accreditation. The test results relate only to the items tested. This test report shall not be reproduced in any form except in full with the written approval of Hermon Laboratories Ltd. Report ID: NYXRAD_FCC.46250_BLE_Rev2.docx Date of Issue: 7-Jun-23 Page 2 of 59 Table of contents 1 Applicant information ..................................................................................................................................................... 3 2 Equipment under test attributes .................................................................................................................................... 3 3 Manufacturer information .............................................................................................................................................. 3 4 Test details .................................................................................................................................................................... 3 5 Tests summary .............................................................................................................................................................. 4 6 EUT description ............................................................................................................................................................. 5 6.1 General information ....................................................................................................................................................... 5 6.2 Test configuration .......................................................................................................................................................... 6 6.3 Changes made in EUT .................................................................................................................................................. 6 6.4 Transmitter characteristics ............................................................................................................................................ 7 7 Transmitter tests according to 47CFR part 15 subpart C requirements ........................................................................ 8 7.1 Minimum 6 dB bandwidth .............................................................................................................................................. 8 7.2 Peak output power ...................................................................................................................................................... 13 7.3 Field strength of spurious emissions ........................................................................................................................... 22 7.4 Band edge radiated emissions .................................................................................................................................... 40 7.5 Peak spectral power density ....................................................................................................................................... 46 7.6 Antenna requirements ................................................................................................................................................. 51 8 APPENDIX A Test equipment and ancillaries used for tests ....................................................................................... 52 9 APPENDIX B Test equipment correction factors ......................................................................................................... 53 10 APPENDIX C Measurement uncertainties .................................................................................................................. 56 11 APPENDIX D Test laboratory description ................................................................................................................... 57 12 APPENDIX E Specification references........................................................................................................................ 58 13 APPENDIX F Abbreviations and acronyms ................................................................................................................. 59 Report ID: NYXRAD_FCC.46250_BLE_Rev2.docx Date of Issue: 7-Jun-23 Page 3 of 59 1 Applicant information Client name: Nyxoah Ltd. Address: 126 Yigal Alon, Tel Aviv 6744332, Israel Telephone: +972-3-6209597 E-mail: [email protected] Contact name: Mr. Dvir Itzhakov 2 Equipment under test attributes Product name: The Genio® System 2.1 consisting of: • Genio® Activation Chip (AC2364) PN: NX-ASM-002325, Serial Numbers: 0121-VV21, 0121-VV24, 0121-VV20, Hardware Version 1.0, BOM Revision 1.0, Software version 1.0.0* • Genio® Implantable Stimulator (IS), PN: NX-ASM-000660, Serial Numbers: 2011019, 2011051, Market BOM Revision 7.0 • Genio® Disposable Patch (DP), PN: NX-ASM-000650, Hardware version 3.0 • Genio® Charging Unit (CU2238) PN: NX-ASM-002330, Serial Numbers: 0121VV13, 0121-VV44, Hardware Version 1.0, BOM Revision 1.0 • Extern…
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Description: 3216 2.4G Chip Antenna PART NUMBER: ANT3216LL00R2400A In the effort to improve our products, we reserve the right to make changes judged to be necessary. CONFIDENTIAL AND PROPRIETARY INFORMATION This document contains confidential and proprietary information of Pulse Electronics, Inc. (Pulse) and is protected by copyright, trade secret and other state and federal laws. Its receipt or possession does not convey any rights to reproduce, disclose its contents, or to manufacture, use or sell anything it may describe. Reproduction, disclosure or use without specific written authorization of Pulse is strictly forbidden. For more information: Pulse Worldwide Headquarters Pulse/Larsen Antennas Europe Headquarters Pulse (Suzhou) Wireless Products Co, Inc. 15255 Innovation Drive #100 Pulse GmbH & Do, KG 99 Huo Ju Road(#29 Bldg,4 th Phase San Diego, CA 92128 Vancouver, WA 98683 Zeppelinstrasse 15 Suzhou New District USA USA Herrenberg, Germany Jiangsu Province, Suzhou 215009 PR China Tel:1-858-674-8100 Tel: 1-360-944-7551 - Tel: 49 7032 7806 0 Tel: 86 512 6807 9998 18110 SE 34 th St Bldg 2 Suite 250 Features: Applications: •Size : 3.2x1.6x1.2 mm •Working Frequency : 2.4~2.5GHz •Omni-directional Radiation •Tape & reel automatic mounting •Reflow process compatible •RoHS compliant •2.4GHz WiFi device •Bluetooth gadget •Zigbee device •ISM band equipment 1 In the effort to improve our products, we reserve the right to make changes judged to be necessary. CONFIDENTIAL AND PROPRIETARY INFORMATION This document contains confidential and proprietary information of Pulse Electronics, Inc. (Pulse) and is protected by copyright, trade secret and other state and federal laws. Its receipt or possession does not convey any rights to reproduce, disclose its contents, or to manufacture, use or sell anything it may describe. Reproduction, disclosure or use without specific written authorization of Pulse is strictly forbidden. Description: 3216 2.4G Chip Antenna PART NUMBER: ANT3216LL00R2400A 2 ELECTRICAL SPECIFICATIONS MECHANICAL DRAWING Working Frequency 2.4-2.5 GHz Bandwidth 160 MHz(Typ.) Polarization Linear Azimuth Beamwidth Omni-directional Peak Gain 5.05 dBi(Typ.) Impedance 50 Ω Operating Temperature - 40~105 °C Maximum Power 1 W Termination Ni / Sn (Environmentally-Friendly Leadless) Resistance to Soldering Heats 260 °C , 10sec. NOTE 1. The specification is defined on Pulse evaluation board Dimension L (mm) 3.2 ± 0.15 W (mm) 1.6 ± 0.15 T (mm) 1.2 ± 0.15 C (mm) 0.4 ± 0.20 Terminal name Function S1 Feeding Point S2 Soldering Point In the effort to improve our products, we reserve the right to make changes judged to be necessary. CONFIDENTIAL AND PROPRIETARY INFORMATION This document contains confidential and proprietary information of Pulse Electronics, Inc. (Pulse) and is protected by copyright, trade secret and other state and federal laws. Its receipt or possession does not convey any rights to reproduce, disclose its contents, or to manufacture, use or sell anything it may describe. Reproduction, disclosure or use without specific written authorization of Pulse is strictly forbidden. Description: 3216 2.4G Chip Antenna PART NUMBER: ANT3216LL00R2400A 3 REFERENCE DESIGN OF EVALUATION BOARD Outlook and dimension of evaluation board Details of soldering Pad In the effort to improve our products, we reserve the right to make changes judged to be necessary. CONFIDENTIAL AND PROPRIETARY INFORMATION This document contains confidential and proprietary information of Pulse Electronics, Inc. (Pulse) and is protected by copyright, trade secret and other state and federal laws. Its receipt or possession does not convey any rights to reproduce, disclose its contents, or to manufacture, use or sell anything it may describe. Reproduction, disclosure or use without specific written authorization of Pulse is strictly forbidden. Description: 3216 2.4G Chip Antenna PART NUMBER: ANT3216LL00R2400A 4 ELECTRICAL PERFORMANCES Return loss Radiation pattern Max gain = 5.05 dBi, at (180, 60) MEG (mean effective gain)= 0.45dBi Directivity (dB) = 7.15 Efficiency = -1.50dB, 70.74% Marker data 1. 2.37GHz, -10dB 2. 2.45GHz, -27.3dB 3. 2.53GHz, -10dB In the effort to improve our products, we reserve the right to make changes judged to be necessary. CONFIDENTIAL AND PROPRIETARY INFORMATION This document contains confidential and proprietary information of Pulse Electronics, Inc. (Pulse) and is protected by copyright, trade secret and other state and federal laws. Its receipt or possession does not convey any rights to reproduce, disclose its contents, or to manufacture, use or sell anything it may describe. Reproduction, disclosure or use without specific written authorization of Pulse is strictly forbidden. Description: 3216 2.4G Chip Antenna PART NUMBER: ANT3216LL00R2400A 5 REVISION HISTORY Revision Date Description Version 1 Oct. 13, 2020 - New issue Mouser Electronics Authorized Distributor Click to View Pricing, Inventory, Delivery & Lifecycle Information: Pulse: ANT3216LL00R2400A
Nyxoah Ltd. Genio ® system 2.1 Project #46250 Page 1 of 9 SETUP PHOTOGRAPHS This document contains 8 photographs Nyxoah Ltd. Genio ® system 2.1 Project #46250 Page 2 of 9 Photograph No.1 Carrier field strength measurement setup for BLE Nyxoah Ltd. Genio ® system 2.1 Project #46250 Page 3 of 9 Photograph No.2 Carrier field strength measurement setup for BLE Nyxoah Ltd. Genio ® system 2.1 Project #46250 Page 4 of 9 Photograph No.3 Carrier field strength measurement setup for BLE Nyxoah Ltd. Genio ® system 2.1 Project #46250 Page 5 of 9 Photograph No.4 OATS Setup for carrier field strength measurements below 30 MHz, 10 m distance for 8MHz Nyxoah Ltd. Genio ® system 2.1 Project #46250 Page 6 of 9 Photograph No.5 OATS Setup for carrier field strength measurements below 30 MHz, 5 m distance for 8MHz Nyxoah Ltd. Genio ® system 2.1 Project #46250 Page 7 of 9 Photograph No.6 OATS Setup for carrier and spurious emission field strength measurements below 30 MHz, 3 m distance for 8MHz Nyxoah Ltd. Genio ® system 2.1 Project #46250 Page 8 of 9 Photograph No.7 SAC Setup for carrier field strength measurements below 30 MHz, 3 m distance for 8MHz Nyxoah Ltd. Genio ® system 2.1 Project #46250 Page 9 of 9 Photograph No.8 SAC Setup for spurious emission field strength measurements above 30 MHz, 3 m distance for 8MHz
| # | Rule Parts | Frequency Range | Power Output |
|---|---|---|---|
| 1 | 15C | 2.40 GHz - 2.48 GHz | 30.00 µW |