2A8XS-9005AZTRACK

SOLTEC HEALTH USER MANUAL Welcome to SOLTEC Health! We appreciate you joining us as we work to help the world achieve the significant health and wellbeing benefits of improved sleep. Important Safety Information Read carefully before use. Failure to follow these instructions could result in serious injury or death. DISCLAIMER: The SOLTEC Sleep Enhancement System (SES) is not intended to diagnose, treat, cure or prevent disease. It is not a substitute for professional medical advice. Individual results vary. Consult with a medical provider for solutions that may be appropriate for you. WARNING: Maintain a safe distance of at least six inches between the SOLTEC•SES™ and a pacemaker, implantable cardioverter defibrillator, deep brain stimulator or other active implantable device. The System may interfere with these devices and increase the risk of injury, illness or death. Consult with a medical provider on whether the System could affect your implantable medical device. CAUTION: The SOLTEC•SES has not been tested during pregnancy. Consult with a medical provider prior to use during pregnancy. CAUTION: The SOLTEC•SES has not been tested on persons under the age of 18. Consult with a medical provider before use by anyone under the age of 18. Avoid placing the SOLTEC•SES and power cord where they could present a tripping hazard. Do not use the Z•GEN™ Magnetic Conditioner around water or other liquids. Like any electronic device, there is an electrocution risk if you get Z•GEN wet when it is plugged in. The Z•TRACK™ Analyst contains electronics and therefore to avoid damage do not expose to water or liquids. Z•TRACK may be cleaned with a soft cloth. Do not disassemble Z•GEN, Z•TRACK or the power adapter. There are no repairs you can safely perform. If you experience redness or skin irritation on your wrist due to the Z•TRACK band, remove it immediately. If symptoms persist longer than 2-3 days of not using Z•TRACK, please contact a dermatologist. Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. Consignes de sécurité importantes A lire attentivement avant toute utilisation. La non-observation de ces instructionspourrait entraîner des blessures graves ou la mort. CLAUSE DE NON-RESPONSABILITÉ: Le système d'amélioration du sommeil (SES) de SOLTEC ne vise pas à diagnostiquer, traiter, guérir ou prévenir les maladies. Il ne constitue pas un substitut à un avis médical professionnel. Chaque individu peut obtenir des résultats différents. Consultez un fournisseur de soins médicaux pour connaître les solutions qui pourraient vous convenir. AVERTISSEMENT: Maintenez une distance de sécurité d'au moins quinze centimeters entre le SOLTEC•SES™ et un stimulateur cardiaque, un défibrillateur automatique implantable, un stimulateur cérébral profond ou tout autre dispositif implantable actif. Le système peut interférer avec ces dispositifs et augmenter le risque de blessure, de maladie ou de décès. Consultez un fournisseur de soins médicaux pour savoir si le système pourrait affecter votre dispositif médical implantable. ATTENTION: Le SOLTEC•SES n'a pas été testé pendant la grossesse. Consultez un fournisseur de soins médicaux avant toute utilisation pendant la grossesse. ATTENTION: Le SOLTEC•SES n'a pas été testé sur des personnes âgées de moins de 18 ans. Consultez un fournisseur médical avant de l'utiliser sur des personnes de moins de 18 ans. Évitez de placer le SOLTEC•SES et le cordon d'alimentation à un endroit où ils pourraient présenter un risque de trébuchement. N'utilisez pas le conditionneur magnétique Z•GEN™ à proximité d'eau ou d'autres liquides. Comme tout appareil électronique, il existe un risque d'électrocution si la prise Z•GEN se mouille lorsqu'elle est branchée. Le Z•TRACK™ Analyst contient de l'électronique et donc, pour éviter tout dommage, ne l'exposez pas à l'eau ou aux liquides. Le Z•TRACK peut être nettoyé avec un chiffon doux. Ne pas démonter le Z•GEN, le Z•TRACK ou l'adaptateur secteur. Il n'existe aucune réparation que vous pouvez effectuer en toute sécurité. Si vous ressentez une rougeur ou une irritation cutanée sur votre poignet due à la bande Z•TRACK, retirez-la immédiatement. Si les symptômes persistent au-delà de 2 ou 3 jours sans utilisation du Z•TRACK, veuillez contacter un dermatologue. Support and Questions If you have any questions about setting up or using your SOLTEC•SES, or you have any issues with your product, please refer to the Frequently Asked Questions (FAQs) at soltechealth.com/faqs. If you can’t find what you’re looking for, send us an email at [email protected]. Product Specifications Battery: 250 mAh Lithium Polymer Charging: Wired via outlet/AC/DC usb plug Operating Temp: 55-125 F Charging Cable: USB - MICRO Charging Time: Between 20 – 150 minutes depending on Z•TRACK starting charge level. Memory: To sync Z•TRACK daily with the SOLTEC•Z App. Z•TRACK is capable of storing up to 30 days’ worth of data depending on type and frequency of use. Red and Green Light-Emitting Diodes (LED): In the visible color range. Connectivity: Bluetooth Low Energy Firmware Updates: Automatic firmware updates via SOLTEC•Z App. Equipment intended to be supplied by an external 5Vdc supply that complies with IEC 62368-1 standard. Limited Warranty Terms and Conditions What is Covered? The SOLTEC•SES™ consisting of the Z•GEN™ Magnetic Conditioner and Z•TRACK™ Analyst are warranted against original defects in materials and workmanship for a period of one year from the date of purchase, when used for normal domestic purposes. Within this period, SOLTEC HEALTH will, at its sole option, replace any components that fail in normal use. Please contact SOLTEC via email at [email protected] to schedule warranty service. What is Not Covered? SOLTEC HEALTH shall not be liable for costs or damages incurred as a result of, due to, or from: • Cosmetic damage, including but not limited to s…

Text truncated - open the document above for the full version.

Round River Research Corporation 10035 Gristmill Drive Eden Prairie, MN, 55347 TEL: 952-292-5763 www.soltechealth.com Date 11/29/2022 ROUND RIVER RESEARCH Cover Letter for Application – FCC Re: Cover Letter for FCC Application FCC ID: 2A8XS-9005A Model: 9005A Radio: Bluetooth LE To whom it may concern, Round River Research Corporation is submitting the ZTRACK Sleep Analyst for original FCC certification (Model 9005A), a consumer product, under FCC Rule Part FCC 15.247:2022. Sincerely, David Cohen Director Operations Round River Research Corporation.

Round River Research Corporation 10035 Gristmill Ridge Eden Prairie, MN, 55347 (952) 292-5763 Request for Confidentiality 12/5/2022 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 Re: Request for confidentiality FCC ID: 2A8XS-9005A To whom it may concern, We hereby respectfully request that under the provision of 47 CFR 0.459 and 0.457(d) the documents listed below and attached with this application for certification be provided with confidential status. • Schematics (ZTrack_Analyst_RevI.pdf) • Operational Description (ZTRACK Operation Description.docx) • Frequency Block Diagram (ZTRACK BLE Block_Rev1.pdf) Any exhibit / information for which we have requested confidentiality, but which may not be accorded such treatment by the FCC, should be returned to us. The documents listed above contain trade secrets that are treated as confidential by us. Substantial competitive harm to us could result should they be made available to the public. Sincerely, David Cohen Director Operations

ZTRACK Analyst™ Regulatory Labeling  Packaging  Product E-Label - Packaging referenced User Manual includes the following access directions. Accessing Regulatory Information Electronically o From Soltec•Z™ smartphone application o Access “Settings” from the ‘My Night’ view o Select Z•TRACK o Access submenu “Regulatory” o E-label smartphone application screenshots based on access directions.

Round River Research Corporation 10035 Gristmill Ridge Eden Prairie, MN, 55347 (952) 292-5763 Z•TRACK Analyst™ Antenna Design Attestation 12/8/2022 Re: Antenna Information Model: 9005A To whom it may concern, We hereby attest that the antenna design implemented in the referenced product model has accurately followed the antenna design and layout guidelines offered by semiconductor manufacturer Infineon, in the form of application note AN91445, specific to the antenna type Inverted-F(IFA) found in Sections 7.4 and Section 10 – Table 5(column IFA). Sincerely, David Cohen Director Operations

ZTRACK Analyst™ Antenna Information  Design follows Cypress application note: ‘AN91445 – Antenna Design and RF Layout Guidelines’ o Sections 7.4 - Inverted-F Antenna : Section 10 – Antenna Comparison Table 5-column IFA

This report must not be used to claim product certification, approval, or endorsement by A2LA or any agency of the U.S. Government. This Report shall not be reproduced, except in full without written approval of the laboratory. Round River Research dba Soltec Health ZTrack FCC 1.1307:2022 Bluetooth Low Energy Report: TRLL0001.1, Issue Date: December 15, 2022 CERTIFICATE OF EVALUATION 2018-09-14 Product compliance is the responsibility of the client; therefore, the tests and equipment modes of operation represented in this report were agreed upon by the client, prior to testing. The results of this test pertain only to the sample(s) tested. The specific description is noted in each of the individual sections of the test report supporting this certificate of test. This report reflects only those tests from the referenced standards shown in the certificate of test. It does not include inspection or verification of labels, identification, marking or user information. As indicated in the Statement of Work sent with the quotation, Element’s standard process is to always use the latest published version of the test methods even when earlier versions are cited in the test specification. Issuance of a purchase order was de facto acceptance of this approach. Otherwise, the client would have advised Element in writing of the specific version of the test methods they wanted applied to the subject testing Last Date of Evaluation: December 8, 2022 Round River Research dba Soltec Health EUT: ZTrack RF Exposure Evaluation Standards Specification Method FCC 1.1307:2022 FCC 1.1307:2022 Results Method Clause Description Applied Results Comments (b)(3)(i)(A) Exemption From RF Exposure Evaluation Yes Pass None Deviations From Evaluation Standards None Approved By: Donald Facteau, Process Architect Report No. TRLL0001.12/11 REVISION HISTORY 2018.07.17 Revision Number Description Date (yyyy-mm-dd) Page Number 00 None Report No. TRLL0001.13/11 ACCREDITATIONS AND AUTHORIZATIONS 2021.09.01 United States FCC - Designated by the FCC as a Telecommunications Certification Body (TCB). Certification chambers, Open Area Test Sites, and conducted measurement facilities are listed with the FCC. A2LA - Each laboratory is accredited by A2LA to ISO / IEC 17025, and as a product certifier to ISO / IEC 17065 which allows Element to certify transmitters to FCC and IC specifications. Canada ISED - Recognized by Innovation, Science and Economic Development Canada as a Certification Body (CB) and as a CAB for the acceptance of test data. European Union European Commission – Recognized as an EU Notified Body validated for the EMCD and RED Directives. United Kingdom BEIS – Recognized by the UK as an Approved Body under the UK Radio Equipment and UK EMC Regulations. Australia/New Zealand ACMA - Recognized by ACMA as a CAB for the acceptance of test data. Korea MSIT / RRA - Recognized by KCC’s RRA as a CAB for the acceptance of test data. Japan VCCI - Associate Member of the VCCI. Conducted and radiated measurement facilities are registered. Taiwan BSMI – Recognized by BSMI as a CAB for the acceptance of test data. NCC - Recognized by NCC as a CAB for the acceptance of test data. Singapore IDA – Recognized by IDA as a CAB for the acceptance of test data. Israel MOC – Recognized by MOC as a CAB for the acceptance of test data. Hong Kong OFCA – Recognized by OFCA as a CAB for the acceptance of test data. Vietnam MIC – Recognized by MIC as a CAB for the acceptance of test data. SCOPE For details on the Scopes of our Accreditations, please visit: California Minnesota Oregon Texas Washington Report No. TRLL0001.14/11 FACILITIES 2020.12.15 California Labs OC01-17 41 Tesla Irvine, CA 92618 (949) 861-8918 Minnesota Labs MN01-11 9349 W Broadway Ave. Brooklyn Park, MN 55445 (612)-638-5136 Oregon Labs EV01-12 6775 NE Evergreen Pkwy #400 Hillsboro, OR 97124 (503) 844-4066 Texas Labs TX01-09 3801 E Plano Pkwy Plano, TX 75074 (469) 304-5255 Washington Labs NC01-05 19201 120 th Ave NE Bothell, WA 98011 (425)984-6600 A2LA Lab Code: 3310.04 Lab Code: 3310.05 Lab Code: 3310.02 Lab Code: 3310.03 Lab Code: 3310.06 Innovation, Science and Economic Development Canada 2834B-1, 2834B-3 2834E-1, 2834E-3 2834D-1 2834G-1 2834F-1 BSMI SL2-IN-E-1154R SL2-IN-E-1152R SL2-IN-E-1017 SL2-IN-E-1158R SL2-IN-E-1153R VCCI A-0029 A-0109 A-0108 A-0201 A-0110 Recognized Phase I CAB for ISED, ACMA, BSMI, IDA, KCC/RRA, MIC, MOC, NCC, OFCA US0158 US0175 US0017 US0191 US0157 Report No. TRLL0001.15/11 PRODUCT DESCRIPTION 2018-07-17 Client and Equipment Under Evaluation Information Company Name: Round River Research dba Soltec Health Address: 6801 Everest Ln N City, State, Zip: Maple Grove, MN 55311 Evaluation Requested By: Troy Winsand EUT: ZTrack Date of Evaluation: 12/8/2022 Information Provided by the Party Requesting the Evaluation Functional Description of the Equipment: Z•TRACK is a wrist-worn wearable that monitors pulse related biometrics used to track and analyze sleep patterns. An integrated Bluetooth Low Energy(BLE) radio is contained within and used to communicate with a mobile application to initiate/end recording sessions and sync stored data for display on a user's mobile device. The largest dimension of Z•TRACK(not including the watch band) is approximately 4cm. Objective: To demonstrate compliance with FCC Requirements for RF exposure for 1.1307 RF exempt devices Report No. TRLL0001.16/11 RF EXPOSURE CONDITION 2018-07-17 The following RF Exposure conditions were used for the assessment documented in this report: Intended Use Portable Location on Body (if applicable) Limb How is the Device Used <= 20 cm for a limb or extremity Radios Contained in the Same Host Device Bluetooth Low Energy Simultaneous Transmitting Radios None Body Worn Accessories NA Environment General Population/Uncontrolled Exposure Report No. TRLL0001.17/11 EXEMPTION FROM RF EXPOSURE EVALUATION EXRPT.2022.07.12.0 OVERVIEW With respect to the limits on human exposure to RF emissions provided in …

Text truncated - open the document above for the full version.

This report must not be used to claim product certification, approval, or endorsement by A2LA or any agency of the U.S. Government. This Report shall not be reproduced, except in full without written approval of the laboratory. Round River Research dba Soltec Health ZTrack FCC 15.247:2022 RSS-247 Issue 2:2017 RSS-Gen Issue 5:2018+A1:2019+A2:2021 Bluetooth LE (DTS) Report: TRLL0001.3 Rev. 1, Issue Date: December 13, 2022 CERTIFICATE OF TEST 2022.04.01 Product compliance is the responsibility of the client; therefore, the tests and equipment modes of operation represented in this report were agreed upon by the client, prior to testing. The results of this test pertain only to the sample(s) tested. The specific description is noted in each of the individual sections of the test report supporting this certificate of test. This report reflects only those tests from the referenced standards shown in the certificate of test. It does not include inspection or verification of labels, identification, marking or user information. As indicated in the Statement of Work sent with the quotation, Element’s standard process is to always use the latest published version of the test methods even when earlier versions are cited in the test specification. Issuance of a purchase order was de facto acceptance of this approach. Otherwise, the client would have advised Element in writing of the specific version of the test methods they wanted applied to the subject testing. Last Date of Test: December 2, 2022 Round River Research dba Soltec Health EUT: ZTrack Radio Equipment Testing Standards Specification Method FCC 15.247:2022 ANSI C63.10:2013, FCC KDB 558074 RSS-247 Issue 2:2017 RSS-Gen Issue 5:2018+A1:2019+A2:2021 ANSI C63.10:2013 Results Test Description Result FCC Section(s) RSS Section(s) ANSI C63.10 Section(s) Comments Band Edge Compliance Pass 15.247(d), KDB 558074 -8.5 RSS-247 5.5 11.11 DTS Bandwidth (6 dB) Pass 15.247(a)(2), KDB 558074 -8.2 RSS-247 5.2(a) 11.8.2 Duty Cycle N/A KDB 558074 -6.0 RSS-Gen 3.2 11.6 Operates at 100%. Equivalent Isotropic Radiated Power Pass 15.247(b)(3), KDB 558074 -8.3.1 RSS-247 5.4(d, f), RSS-Gen 6.12 11.9.1.1 Occupied Bandwidth (99%) Pass KDB 558074 -2.1 RSS-Gen 6.7 6.9.3 Output Power Pass 15.247(b)(3), KDB 558074 -8.3.1 RSS-247 5.4(d, f), RSS-Gen 6.12 11.9.1.1 Power Spectral Density Pass 15.247(e), KDB 558074 -8.4 RSS-247 5.2(b) 11.10.2 Powerline Conducted Emissions Pass 15.207 RSS-Gen 8.8 6.2 Spurious Conducted Emissions Pass 15.247(d), KDB 558074 -8.5 RSS-247 5.5 11.11 Spurious Radiated Emissions Pass 15.247(d), KDB 558074 - 8.6, 8.7 RSS-247 5.5, RSS-Gen 6.13, 8.10 11.12.1, 11.13.2, 6.5, 6.6 Deviations From Test Standards None Approved By: Eric Brandon, Department Manager Report No. TRLL0001.3 Rev 12/61 REVISION HISTORY 2018.07.17 Revision Number Description Date (yyyy-mm-dd) Page Number 01 added mod type, deselected rated power settings 2022-12-13 11 updated last test date on mods and PD pages 2022-12-13 10, 13 added missing equipment 2022-12-13 50 Report No. TRLL0001.3 Rev 13/61 ACCREDITATIONS AND AUTHORIZATIONS 2021.09.01 United States FCC - Designated by the FCC as a Telecommunications Certification Body (TCB). Certification chambers, Open Area Test Sites, and conducted measurement facilities are listed with the FCC. A2LA - Each laboratory is accredited by A2LA to ISO / IEC 17025, and as a product certifier to ISO / IEC 17065 which allows Element to certify transmitters to FCC and IC specifications. Canada ISED - Recognized by Innovation, Science and Economic Development Canada as a Certification Body (CB) and as a CAB for the acceptance of test data. European Union European Commission – Recognized as an EU Notified Body validated for the EMCD and RED Directives. United Kingdom BEIS – Recognized by the UK as an Approved Body under the UK Radio Equipment and UK EMC Regulations. Australia/New Zealand ACMA - Recognized by ACMA as a CAB for the acceptance of test data. Korea MSIT / RRA - Recognized by KCC’s RRA as a CAB for the acceptance of test data. Japan VCCI - Associate Member of the VCCI. Conducted and radiated measurement facilities are registered. Taiwan BSMI – Recognized by BSMI as a CAB for the acceptance of test data. NCC - Recognized by NCC as a CAB for the acceptance of test data. Singapore IDA – Recognized by IDA as a CAB for the acceptance of test data. Israel MOC – Recognized by MOC as a CAB for the acceptance of test data. Hong Kong OFCA – Recognized by OFCA as a CAB for the acceptance of test data. Vietnam MIC – Recognized by MIC as a CAB for the acceptance of test data. SCOPE For details on the Scopes of our Accreditations, please visit: California Minnesota Oregon Texas Washington Report No. TRLL0001.3 Rev 14/61 FACILITIES 2020.12.15 California Labs OC01-17 41 Tesla Irvine, CA 92618 (949) 861-8918 Minnesota Labs MN01-11 9349 W Broadway Ave. Brooklyn Park, MN 55445 (612)-638-5136 Oregon Labs EV01-12 6775 NE Evergreen Pkwy #400 Hillsboro, OR 97124 (503) 844-4066 Texas Labs TX01-09 3801 E Plano Pkwy Plano, TX 75074 (469) 304-5255 Washington Labs NC01-05 19201 120 th Ave NE Bothell, WA 98011 (425)984-6600 A2LA Lab Code: 3310.04 Lab Code: 3310.05 Lab Code: 3310.02 Lab Code: 3310.03 Lab Code: 3310.06 Innovation, Science and Economic Development Canada 2834B-1, 2834B-3 2834E-1, 2834E-3 2834D-1 2834G-1 2834F-1 BSMI SL2-IN-E-1154R SL2-IN-E-1152R SL2-IN-E-1017 SL2-IN-E-1158R SL2-IN-E-1153R VCCI A-0029 A-0109 A-0108 A-0201 A-0110 Recognized Phase I CAB for ISED, ACMA, BSMI, IDA, KCC/RRA, MIC, MOC, NCC, OFCA US0158 US0175 US0017 US0191 US0157 Report No. TRLL0001.3 Rev 15/61 MEASUREMENT UNCERTAINTY TMU.2015.07.10 Measurement Uncertainty When a measurement is made, the result will be different from the true or theoretically correct value. The difference is the result of tolerances in the measurement system that cannot be completely eliminated. To the extent that technology allows us, it has been our aim to minimize this error. Measurement uncertainty is a statist…

Text truncated - open the document above for the full version.

XMit 2022.02.07.0 LAB 001.JPG LAB 002.JPG DIRECT CONNECT POWERLINE CONDUCTED EMISSIONS WTD.2022.07.28.0 EmiR5 2022.07.06.0 PSA-ESCI 2022.08.23.0 Report No. TRLL0001.3 Photos Only2/4 SPURIOUS RADIATED EMISSIONS WTD.2022.07.28.0 EmiR5 2022.07.06.0 PSA-ESCI 2022.08.23.0 Report No. TRLL0001.3 Photos Only3/4 SPURIOUS RADIATED EMISSIONS WTD.2022.07.28.0 EmiR5 2022.07.06.0 PSA-ESCI 2022.08.23.0 Report No. TRLL0001.3 Photos Only4/4