
Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.
1 To be included in Safety Information New to be translated To be translated and included in the Safety Information Thank you for choosing Oxa. Read this leaflet and the accompanying documentation carefully before using the Oxa sensor, garment, the Oxa Life App, Oxa, or other related services. Failure to follow the instructions could result in product damage, malfunction, or injury. Keep all safety information and instructions for future reference and provide them to subsequent users of the product. Visitsupport.oxalife.com to: ●access the latest version of all Oxa product documentation. ●contact Oxa Support and request assistance, instructions, or information. ●submit any comments or feedback regarding what is good and what can be improved. Oxa values comments from its users. User Manual 1. About Oxa Reconnect with your body 2 In today’s world, many people are losing their connection to their bodies as they are constantly put under pressure and exposed to mental stress. Oxa allows you to reconnect with yourself using an ancient link between body and mind: your breathing. “Life with Oxa” is all about giving you the resources you need to give your life a breath of fresh air. [1] Oxa allows you to monitor and influence your nervous system with the aim of improving your well-being. Oxa leverages a proprietary biofeedback app powered by next-gen smart garments and precision technology to help you influence your autonomic nervous system. That is the part of your nervous system that controls involuntary bodily functions like breathing and your heart beating. [1] Oxa allows you to reconnect with yourself by strengthening the link between your body and mind through conscious breathing. As a result, Oxa can help relieve everyday stress, sharpen your focus and improve your sleep quality. What can you do with Oxa? With Oxa, you can monitor your physiological parameters and state in real time, observe their past and future trends, and understand the long-term impact of your everyday activities on your health. Oxa technology 3 [Animated renders of e-components + sensor to explain the technology] Smart garments Oxa’s technology consists of state-of-the-art e-textile components and sensors that are seamlessly integrated into a comfortable, modern shirt or bra you can wash. The connected garment communicates with an exclusive app that guides you while keeping your data anonymous and secure. It is a powerful tool putting you in the driver’s seat on your health journey. Oxa bras and shirts are made with a breathable, comfortable fabric with a lovely soft texture and plenty of stretch. Biosensors 4 Lung activity: Oxa uses proprietary technology to measure your breathing depth and rate in real time. Heart activity: our very own state-of-the-art dry adhesive electrodes detect complete heart activity via an electrocardiogram (ECG) from which the heart rate (HR) and heart rate variability (HRV) are extracted in real time. Resting HR and HRV are key indicators of the level of stress the nervous system is under. By monitoring lung and heart activity together, Oxa provides a powerful framework for measuring the activity of the parasympathetic nervous system, which relaxes your body after periods of stress. Skin temperature: a highly accurate built-in infrared sensor detects the skin surface temperature by measuring heat radiation. Accelerometer: the sensor is equipped with an accelerometer which provides information on your movements and position. [image: 001_warning-icon.png] [3]Important safety information Oxa is not a medical device. Please note that Oxa is not designed to diagnose, treat, cure or prevent diseases or medical conditions. The information and guidance in the Oxa journey are provided for informational purposes only and should not 5 be used as an alternative to advice given by physicians or other health professionals. You must always consult a physician if you have any questions regarding a medical condition or any changes you wish to make to your activity or sleep based on information or guidance from Oxa. If you do decide to make any changes to your sleep or activity based on information or guidance from Oxa, you do so entirely at your own risk. It is important to always remain sensitive to your body’s responses. For example, if you feel pain, fatigue or discomfort that is unexpected, repeated or long-term as a result of making changes to your sleep or activity, it is recommended that you speak to a physician before continuing. Information and guidance from Oxa may be interpreted differently if your physiological functions and responses are significantly different than the average physiological functions and responses due to medical conditions or rare natural differences. The Oxa system uses passive electrodes, which do not pose a health hazard. They are biocompatible and do not cause irritation. If you experience any redness or skin irritation due to the electrodes being in contact with your skin for an extended period, remove Oxa immediately. Skin rashes may be caused by friction between the garment and the skin. If any symptoms last for longer than two or three days after you stopped using your Oxa product, contact a physician. If you, or anyone who intends to wear Oxa, have an epileptic condition, consult a physician before you use Oxa. If you experience any of the following symptoms during use – dizziness, altered vision, eye or muscle twitches, loss of 6 awareness, disorientation, involuntary movement, or convulsions – discontinue use IMMEDIATELY and speak to a physician. Hyperventilation in power breathing is only suitable for people who are generally healthy. If you have any ongoing health conditions — or if you suffer from anxiety — please consult your doctor before practicing hyperventilation. If you are pregnant, don’t practice hyperventilation. Long breath holds could harm your baby. The Oxa sensor complies with Directive 2014/53/EU and meets the FCC Radio Frequency Radiation Exposure…
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Thank you for choosing Oxa. Read this leaflet and the accompanying documentation carefully before using the Oxa sensor, garment, the Oxa Life App, Oxa, or other related services. Failure to follow the instructions could result in product damage, malfunction, or injury. Keep all safety information and instructions for future reference and provide them to subsequent users of the product. Visit support.oxalife.com to: ●access the latest version of all Oxa product documentation. ●contact Oxa Support and request assistance, instructions, or information. ●submit any comments or feedback regarding what is good and what can be improved. Oxa values comments from its users. Oxa User Manual 1. About Oxa Reconnect with your body In today’s world, many people are losing their connection to their bodies as they are constantly put under pressure and exposed to mental stress. Oxa allows you to reconnect with yourself using an ancient link between body and mind: your breathing. “Life with Oxa” is all about giving you the resources you need to give your life a breath of fresh air. Oxa allows you to monitor and influence your nervous system with the aim of improving your well-being. Oxa leverages a proprietary biofeedback app powered by next-gen smart garments and precision technology to help you influence your autonomic nervous system. That is the part of your nervous system that controls involuntary bodily functions like breathing and your heart beating. Oxa allows you to reconnect with yourself by strengthening the link between your body and mind through conscious breathing. As a result, Oxa can help relieve everyday stress, sharpen your focus and improve your sleep quality. What can you do with Oxa? With Oxa, you can monitor your physiological parameters and state in real time, observe their past and future trends, and understand the long-term impact of your everyday activities on your health. 1 Smart garments Oxa’s technology consists of state-of-the-art e-textile components and sensors that are seamlessly integrated into a comfortable, modern shirt or bra you can wash. The connected garment communicates with an exclusive app that guides you while keeping your data anonymous and secure. It is a powerful tool putting you in the driver’s seat on your health journey. Oxa bras and shirts are made with a breathable, comfortable fabric with a lovely soft texture and plenty of stretch. Biosensors Lung activity: Oxa uses proprietary technology tomeasure your breathing depth and rate in real time. Heart activity: our very own state-of-the-art dryadhesive electrodes detect complete heart activity via an electrocardiogram (ECG) from which the heart rate (HR) and heart rate variability (HRV) are extracted in real time. Resting HR and HRV are key indicators of the level of stress the nervous system is under. By monitoring lung and heart activity together, Oxa provides a powerful framework for measuring the activity of the parasympathetic nervous system, which relaxes your body after periods of stress. Skin temperature: a highly accurate built-in infraredsensor detects the skin surface temperature by measuring heat radiation. Accelerometer:the sensor is equipped with an accelerometerwhich provides information on your movements and position. [image: 001_warning-icon.png] Important safety information Oxa is not a medical device. Please note that Oxa is not designed to diagnose, treat, cure or prevent diseases or medical conditions. The information and guidance in the Oxa journey are provided for informational purposes only and should not be used as an alternative to advice given by physicians or other health professionals. You must always consult a physician if you have any questions regarding a medical condition or any changes you wish to make to your activity or sleep based on information or guidance from Oxa. 2 If you do decide to make any changes to your sleep or activity based on information or guidance from Oxa, you do so entirely at your own risk. It is important to always remain sensitive to your body’s responses. For example, if you feel pain, fatigue or discomfort that is unexpected, repeated or long-term as a result of making changes to your sleep or activity, it is recommended that you speak to a physician before continuing. Information and guidance from Oxa may be interpreted differently if your physiological functions and responses are significantly different than the average physiological functions and responses due to medical conditions or rare natural differences. The Oxa system uses passive electrodes, which do not pose a health hazard. They are biocompatible and do not cause irritation. If you experience any redness or skin irritation due to the electrodes being in contact with your skin for an extended period, remove Oxa immediately. Skin rashes may be caused by friction between the garment and the skin. If any symptoms last for longer than two or three days after you stopped using your Oxa product, contact a physician. If you, or anyone who intends to wear Oxa, have an epileptic condition, consult a physician before you use Oxa. If you experience any of the following symptoms during use – dizziness, altered vision, eye or muscle twitches, loss of awareness, disorientation, involuntary movement, or convulsions – discontinue use IMMEDIATELY and speak to a physician. Hyperventilation in power breathing is only suitable for people who are generally healthy. If you have any ongoing health conditions — or if you suffer from anxiety — please consult your doctor before practicing hyperventilation. If you are pregnant, don’t practice hyperventilation. Long breath holds could harm your baby. The Oxa sensor complies with Directive 2014/53/EU and meets the FCC Radio Frequency Radiation Exposure (SAR) standard. NOTICE: It is splash proof but should not be usedwhile swimming, showering or bathing. Do not expose the sensor to liquids while it is in use or charging. WARNING: Electronic interference. Oxa’s techno…
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Nanoleq AG MWST-Nummer CHE-195.398.322 MWST Hofwisenstrasse 50A | 8153 Rümlang, Schweiz Tel. +41 78 975 10 72 | [email protected] www.nanoleq.com To: SGS North America Inc. 620 Old Peachtree Road SUITE 100 Suwanee, Georgia United States From: Nanoleq AG Hofwiesenstrasse 50A Ruemlang, Zurich, 8153 Regarding: Confidentiality Request regarding application for FCC ID 2A8RQOXA1 LONG TERM CONFIDENTIALITY Pursuant to 47 CFR Section 0.459 and 0.457 of the commission’s rules, the applicant hereby requests confidential treatment of the documents listed below, associated with the certification application referenced above. Block Diagrams Operational Descriptions The documents above contain proprietary information not released to the public. Public disclosure of this information may prove harmful to the business of the applicant. SHORT TERM CONFIDENTIALITY Additionally, the applicant requests the following documents be held confidential until the device is marketed or 180 days from the grant date, whichever is less. If the device is marketed within 180 days of the Grant Date, the applicant will notify the TCB per FCC KDB 726920 D01 Confidentiality Request Procedures. External Photos Internal Photos Test Setup Photos User manual(s) Sincerely, Nanoleq AG MWST-Nummer CHE-195.398.322 MWST Hofwisenstrasse 50A | 8153 Rümlang, Schweiz Tel. +41 78 975 10 72 | [email protected] www.nanoleq.com Serge Weydert Co-Founder, Chief Science and Business Officer Nanoleq AG 08.11.2022
Applicant Declaration Applicant Declaration Rev:0.0 SGS North America Inc. 620 Old Peachtree Road SUITE 100 Suwanee, Georgia 30024 United States Applicant Legal Business Name Nanoleq AG Address Hofwisenstrasse 50A, 8153, Rümlang, Switzerland Grantee Code 2A8RQ FCC ID 2A8RQOXA1 Authorized Contact Name Serge Weydert Contact Email [email protected] Contact Phone 0041765368899 I, the undersigned, certify that I am an authorized signatory for the Applicant and therefore declare; a) in accordance with 47CFR2.911(d), all of the statements herein and the exhibits attached hereto are true and correct to the best of my knowledge and belief. b) in accepting a Grant of Equipment Authorization issued by a TCB, under the authority of the FCC, as a result of the representations made in this application, the Applicant is responsible for: (1) labeling the equipment with the exact FCC ID as specified in this application, (2) compliance statement labeling pursuant to the applicable rules, (3) compliance of the equipment with the applicable technical rules, c) if the Applicant is not the actual manufacturer of the equipment, appropriate arrangements have been made with the manufacturer to ensure that production units of this equipment will continue to comply with the FCC’s technical requirements. d) in accordance with 47 CFR 2.909 and KDB394321, the Applicant has read, understood and agrees to accept that they are the responsible party and agree to abide by their responsibilities as specified under 47 CFR 2.909 and KDB394321. e) in accordance with ISO17065, FCC KDB641163, FCC KDB610077, KDB394321 and RSP-100, the Applicant has read, understood, accepts and agrees to abide by the post market surveillance requirements. (1) the Applicant understands, accepts and agrees that a sample may be requested for surveillance testing. (2) the Applicant shall make provisions to always have a production sample available upon request by SGS, FCC and/or ISED. (3) the Applicant shall, upon request by SGS, at the Applicant’s expense, provide a production sample of the requested product to SGS, FCC and/or ISED as instructed. The sample shall include all support devices, cables, software, accessories or other hardware or software required for evaluation, review, certification and audit surveillance of products certified by SGS. f) neither the Applicant nor any party to the application is subject to a denial of Federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. §862 because of a conviction for possession or distribution of a controlled substance. See 47CFR 1.2002(b) for the definition of a “party” for these purposes. g) the Applicant has read, understood, accepts and agrees to abide by the SGS North America, Inc.(TCB) terms and conditions. Link to CFRs: https://www.fcc.gov/wireless/bureau-divisions/technologies-systems-and-innovation-division/rules-regulations-title-47 Link to KDBs: https://apps.fcc.gov/oetcf/kdb/index.cfm Link to RSP-100: https://www.ic.gc.ca/eic/site/smt-gst.nsf/eng/sf01130.html Applicant Signature: Date: 07.11.2022 Print Name: Serge Weydert Title: Co-Founder, Chief Science and Business Officer *NOTE: This declaration cannot be signed by an Agent, it shall be signed by an authorized person listed in the FCC database
Top Bottom USB connector
Label and packaging Kit Box Magnetic Box Phonestand Packaging Sensor Box Label and packaging Sensor box and Label (concept) Sensor label is placed on the bottom side of the box (sample box)
Reference number: HELEM2207000317-1 Page 1 of 15 These test results are valid for the tested unit only. This report shall not be reproduced, except in full, without a written permission of SGS Fimko. Test Report Electromagnetic Compatibility (EMC) HELEM2207000317-1 TESTS ACCORDING TO FCC PART 15 B AND ISED CANADA REQUIREMENTS Equipment Under Test: Breathing sensor and smart garment Model: Oxa1 Type: - Trademark: OXA Manufacturer / Customer: Nanoleq AG Hofwisenstrasse 50 A 8153 Rümlang Switzerland FCC Rule Part: FCC CFR 47 Part 15 Subpart B, Class B IC Rule Part: ICES-003 Issue 7, Class B Date: 14 November 2022 Date: 14 November 2022 Issued by: Checked by: Henri Mäki Rauno Repo Testing Engineer Senior EMC Specialist Reference number: HELEM2207000317-1 Page 2 of 15 Table of Contents TABLE OF CONTENTS TABLE OF CONTENTS ................................................................................................................................. 2 GENERAL REMARKS ................................................................................................................................... 3 Disclaimer ................................................................................................................................................. 3 RELEASE HISTORY...................................................................................................................................... 4 PRODUCT DESCRIPTION ............................................................................................................................ 5 Equipment Under Test (EUT) .................................................................................................................... 5 General description ................................................................................................................................... 5 Samples and modifications........................................................................................................................ 5 Ports and cables ....................................................................................................................................... 5 Peripherals ............................................................................................................................................... 6 TEST CONDITIONS ...................................................................................................................................... 7 Operation modes ...................................................................................................................................... 7 Emission Measurement Uncertainty .......................................................................................................... 7 SUMMARY OF TESTING .............................................................................................................................. 8 EMISSION TESTS ......................................................................................................................................... 9 Conducted Emissions In The Frequency Range 150 kHz – 30 MHz........................................................... 9 Radiated Emissions In The Frequency Range 30 MHz – 12.5 GHz............................................................ 11 TEST EQUIPMENT ....................................................................................................................................... 15 Conducted emissions ................................................................................................................................ 15 Radiated emissions ................................................................................................................................... 15 Reference number: HELEM2207000317-1 Page 3 of 15 Disclaimer GENERAL REMARKS Disclaimer 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/en/Terms-and-Conditions.aspx and, for electronic format docu- ments, subject to Terms and Conditions for Electronic Documents at http://www.sgs.com/en/Terms-and-Condi- tions/Terms-e-Document.aspx 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 instructions, 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 ap- proval 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. Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 30 days only. Reference number: HELEM2207000317-1 Page 4 of 15 Release History RELEASE HISTORY Version Changes Issued 1.0 Initial release 10 November 2022 1.1 EUT model name corrected 14 November 2022 Reference number: HELEM2207000317-1 Page 5 of 15 Product Description PRODUCT DESCRIPTION Equipment Under Test (EUT) EUT information General Product Description Breathing sensor and smart garment Trademark OXA Model Oxa1 Type - Serial number - Power input port type Battery operated (charging via USB-C) Rated voltage - Rated current - Rated frequency DC Rated power - EUT Highest operation freq. - Hardware Version (if any) - Software Version (if any) - Mechanical size of the EUT (mm) - Parallel models - Radio module or chip Insight SiP ISP1507 The EUT was tested as a tabletop unit. General description The equipment under test is a breathing sensor and a sm…
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Reference number: HELEM2207000317-2 Page 1 of 16 These test results are valid for the tested unit only. This report shall not be reproduced, except in full, without a written permission of SGS Fimko. Test Report HELEM2207000317-2 INTENTIONAL RADIATOR TESTS ACCORDING TO FCC PART 15 C AND ISED CANADA REQUIREMENTS Equipment Under Test: Breathing sensor and smart garment Model: Oxa1 Type: - Trademark: OXA Manufacturer / Customer: Nanoleq AG Hofwisenstrasse 50 A 8153 Rümlang Switzerland FCC Rule Part: 15.247 IC Rule Part: RSS-247, Issue 2, 2017 RSS-GEN Issue 5 Amendment 2, 2021 KDB: 558074 D01 15.247 Meas Guidance v05r02 Guidance for Compliance Measurements on Digital Transmission Systems, Frequency Hopping Spread Spectrum System, and Hybrid System Devices Operating Under §15.247 of the FCC rules (April 2, 2019) - partial testing, see test suite for details Date: 14 November 2022 Date: 14 November 2022 Issued by: Checked by: Henri Mäki Rauno Repo Testing Engineer Senior EMC Specialist Reference number: HELEM2207000317-2 Page 2 of 16 Table of Contents TABLE OF CONTENTS TABLE OF CONTENTS ................................................................................................................................. 2 GENERAL REMARKS ................................................................................................................................... 3 Disclaimer ................................................................................................................................................. 3 RELEASE HISTORY...................................................................................................................................... 4 PRODUCT DESCRIPTION ............................................................................................................................ 5 Equipment Under Test .............................................................................................................................. 5 General Description .................................................................................................................................. 5 Ratings and declarations ........................................................................................................................... 5 Power Supply ............................................................................................................................................ 5 Mechanical Size of the EUT ...................................................................................................................... 5 SUMMARY OF TESTING .............................................................................................................................. 6 Test Conditions ......................................................................................................................................... 6 Test Facility............................................................................................................................................... 7 TEST RESULTS ............................................................................................................................................ 8 Antenna Requirement ............................................................................................................................... 8 AC Power-Line Conducted Emissions ....................................................................................................... 9 Maximum Peak Conducted Output Power ................................................................................................. 11 Radiated Emissions and Band-Edge Measurement (9 kHz to 25 GHz) ...................................................... 13 TEST EQUIPMENT ....................................................................................................................................... 16 AC Power-Line Conducted Emissions ....................................................................................................... 16 Radiated Emissions .................................................................................................................................. 16 Reference number: HELEM2207000317-2 Page 3 of 16 Disclaimer GENERAL REMARKS Disclaimer 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/en/Terms-and-Conditions.aspx and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at http://www.sgs.com/en/Terms-and-Conditions/Terms-e-Document.aspx 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 instructions, 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. Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 30 days only. Reference number: HELEM2207000317-2 Page 4 of 16 Release History Test Report template version: 1.7 RELEASE HISTORY Version Changes Issued 1.0 Initial release 10 November 2022 1.1 EUT model name corrected 14 November 2022 Reference number: HELEM2207000317-2 Page 5 of 16 Product Description PRODUCT DESCRIPTION Equipment Under Test Equipment Under Test: Breathing sensor and smart garment Model: Oxa1 Type: - Trademark: OXA Seri…
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TEST SETUP PHOTOGRAPHS Page 1 of 4 Project number: HELEM2207000317-1 SGS Fimko Ltd. Takomotie 8, FI-00380 Helsinki Finland t +358 9 6963 361 f +358 9 692 5474 www.sgs.fi Member of SGS Group (Société Générale de Surveillance) Photograph 1: Test setup for Conducted Emissions TEST SETUP PHOTOGRAPHS Page 2 of 4 Project number: HELEM2207000317-1 SGS Fimko Ltd. Takomotie 8, FI-00380 Helsinki Finland t +358 9 6963 361 f +358 9 692 5474 www.sgs.fi Member of SGS Group (Société Générale de Surveillance) Photograph 2: The EUT orientation during Radiated Emissions, Operation Mode 1 Photograph 3: Test setup for Radiated Emissions (30-1000 MHz), Operation Mode 1 TEST SETUP PHOTOGRAPHS Page 3 of 4 Project number: HELEM2207000317-1 SGS Fimko Ltd. Takomotie 8, FI-00380 Helsinki Finland t +358 9 6963 361 f +358 9 692 5474 www.sgs.fi Member of SGS Group (Société Générale de Surveillance) Photograph 4: Test setup for Radiated Emissions (1-12.5 GHz), Operation Mode 1 Photograph 5: The EUT orientat…
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| # | Rule Parts | Frequency Range | Power Output |
|---|---|---|---|
| 1 | 15B | - | - |