
Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.
VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION Neuros Medical Inc. Confidential Document Altius ® Direct Electrical Nerve Stimulation System Implantable Pulse Generator Programmer Manual CAUTION: Federal (US) law restricts this device to sale by or on the order of a physician LB-0197 Rev B LB-0197 B Document Number Revision ALTIUS SYSTEM IPG PROGRAMMER MANUAL DCO NUMBER: 24-0096 RELEASE DATE: TBD Page 2 of 40 VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION Neuros Medical Inc. Confidential Document Neuros Medical (USA), Inc 26800 Aliso Viejo Parkway, Suite 250 Aliso Viejo CA 92656, USA Support Phone Number: 833-240-4462 Altius® is a US registered trademark of Neuros Medical. The information provided in this document may change without prior notice. This document and its contents are proprietary to Neuros Medical. No part of this manual may be reproduced, distributed, or transmitted in any form or by any method, including electronic and mechanical means, without prior written express consent from Neuros Medical Please read the complete documentation provided before you use the device. Although FDA has determined that the probable benefits outweigh the probable risks, there remains some uncertainty regarding the manufacturer’s human factors engineering (HFE) and usability engineering (UE) analysis and validation testing. As a condition of approval, FDA is requiring the manufacturer to provide an HFE/UE analysis and validation testing and recommending that this analysis and testing is designed using the FDA’s 2016 guidance document “Applying Human Factors and Usability Engineering to Medical Devices” Copyright © Neuros Medical Inc. 2023 ALL RIGHTS RESERVED. The Altius® System is protected by several U.S. Patents. For an up-to date list of relevant patents and patent applications, visit our patents page: http://www.neurosmedical .com/ patents LB-0197 B Document Number Revision ALTIUS SYSTEM IPG PROGRAMMER MANUAL DCO NUMBER: 24-0096 RELEASE DATE: TBD Page 3 of 40 VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION Neuros Medical Inc. Confidential Document Table of Contents 1. Explanation of Symbols .......................................................................................................... 6 2. Altius Programmer System Overview ................................................................................... 7 2.1. Description of Altius Programmer System ....................................................................... 7 2.2. Programmer Functions .................................................................................................... 8 2.3. Programmer Components ................................................................................................ 8 2.4. Interconnecting the Programmer components for Operation ........................................... 8 2.5. Programmer Wand .......................................................................................................... 9 2.6. Charging the Battery of the Altius PAPC ......................................................................... 10 2.7. Operating the Altius Programmer System ...................................................................... 10 2.8. Using the Altius PAPC Touch Screen (If Available) ......................................................... 10 2.9. Buttons and Symbols on the Altius PAPC........................................................................ 11 2.10. Altius PAPC Battery Replacement .................................................................................. 11 2.11. Routine Cleaning ............................................................................................................ 11 2.12. Storage, Handling and Usage .......................................................................................... 11 2.13. Additional Notes ............................................................................................................ 12 2.14. Cautions and Warnings ............................................................................................... 13 2.14.1. Implanted components and MRI scans ............................................................... 13 2.14.2. Electromagnetic Interference ............................................................................. 13 2.14.3. Surgical Cautions and Warnings ......................................................................... 14 3. Altius Programmer Software Overview .............................................................................. 14 3.1. Altius Programmer Start-up ........................................................................................... 14 3.2. Basic Operation of the Altius Programmer Application .................................................. 15 3.2.1. Communicating with the Altius IPG ........................................................................ 15 3.2.2. Interrogation and Programming ............................................................................ 16 3.2.3. Monitoring Tools.................................................................................................... 16 3.2.4. Closing the Altius Programmer Application............................................................ 17 4. Altius Programmer Software Description .......................................................................... 17 4.1. Menu Bar ....................................................................................................................... 17 LB-0197 B Document Number Revision ALTIUS SYSTEM IPG PROGRAMMER MANUAL DCO NUMBER: 24-0096 RELEASE DATE: TBD Page 4 of 40 VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION Neuros Medical Inc. Confidential Document 4.1.1. File Menu ............................................................................................................... 18 4.1.2. Tools Menu ..........................................................................…
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Form: RFT-AMER-TCB-OP-19n Revision: 1 Page 1 of 1 Date: 1/25/2023 Attention: Application Examiner Re: Covered List, located at https://www.fcc.gov/supplychain/coveredlist and 47 CFR parts §2.903 and §2.911(d)(5)(ii) of the FCC rules Applicant: Neuros Medical, Inc FCC ID: 2BATK606 To whom it may concern, Neuros Medical, Inc (“Applicant”) certifies that the equipment for which authorization is sought is not “covered” equipment prohibited from receiving an equipment authorization pursuant to 47 CFR part §2.903 of the FCC rules and does not originate directly or indirectly from any company named on the covered list located in the link above or any subsidiary or affiliate thereof. Applicant further certifies that, as of the date of the filing of the application, the Applicant is not identified on the Covered List as an entity producing “covered” equipment and is not a subsidiary or affiliate of any such entity pursuant to 47 CFR part §1.50002 and required by 47 CFR part §2.911(d)(5)(ii) of the FCC rules. Applicant further certifies that no Cybersecurity or anti-virus software produced or provided by Kaspersky Lab, Inc. or any of its successors and assignees, including equipment with integrated Kaspersky Lab, Inc. (or any of its successors and assignees) cybersecurity or anti-virus software is installed in the equipment being certified. I HEREBY CERTIFY THAT I am authorized to make the representations above on behalf of the Applicant and agree to immediately notify Intertek if there is any change in the status identified above. Raymond Zackowski Principal Systems Engineer Neuros Medical, Inc 01/Oct/2024
Attention: Application Examiner Re: Certification designating a U.S. agent for service of process pursuant to 47 CFR part §2.911(d)(7) of the FCC rules To whom it may concern, This letter is to certify that Neuros Medical, Inc. (“Applicant”) accepts responsibilities to act as its own agent pursuant to 47 CFR part §2.911(d)(7) of the FCC rules for service of process. I consent to the obligation to accept service of process on behalf of the applicant in regard to the FCC ID designated below. I HEREBY CERTIFY THAT I am authorized to make the representations above on behalf of the Applicant. I further acknowledge the requirement to maintain an agent extends for no less than one year after the termination of all marketing and importation or the conclusion of and commission-related proceeding involving the equipment and agree to immediately notify the FCC and Intertek if there is any change in the status identified above. Applicant Company Name : Neuros Medical, Inc. Contact Name : Raymond Zackowski Address : 26800 Aliso Viejo Pkwy, Suite 250, Aliso Viejo, CA 92656 Telephone No : 440 951 2565 ext. 125 Email : [email protected] FCC ID : 2BATK606 Applicant FRN : 0033629213 Signature: ____________________________________ Date: __16-May-2024__________________________________
Attention: Application Examiner Re: Request for confidentiality Applicant: Neuros Medical, Inc. FCC ID: 2BATK601, 2BATK603, 2BATK604, 2BATK606 To whom it may concern, Request is hereby submitted by NEUROS MEDICAL to withhold permanently from public review certain portions of the application for equipment certification for the referenced FCC identifiers. This request for confidentiality is made pursuant to 47 CFR 0.457(d) and 0.459 of the FCC Rules. In particular, the following sections of the application are to be kept permanently confidential: • Schematics • Detailed Block diagrams • Detailed Operational/Functional Description Neuros Medical, Inc. has invested considerable time and materials in research and development to produce the referenced product. Disclosure of the permanently confidential portions of this application to competitors would not only give them significant competitive advantages in developing similar products, but would also disclose successful implementation of unpublished, leading edge technology developed by us. The sale of the device may be subject to non-disclosure of terms. The fee for confidentiality has been submitted along with the fee for certification. If you have questions or need further information, please contact the undersigned. Sincerely, Raymond M Zackowski Principal Systems Engineer Neuros Medical, Inc.
2/07/24 Intertek Testing Services NA Ltd. 70 Codman Hill Road Boxborough, MA 01719 Subject: Limited Agency Agreement Neuros Medical, Inc. FCC ID: 2BATK601, 2BATK603, 2BATK604, 2BATK606 To Whom It May Concern: We, Neuros Medical, Inc., hereby authorized Jean Servais of Intertek Testing Services NA Ltd. to act as our Agent for the purpose of preparing application for FCC ID numbers BATK601, 2BATK603, 2BATK604, 2BATK606 under all applicable parts of the FCC rules and regulations. The effective date of this limited agency agreement is 2/7/2024. The Limited Agency Agreement expires on 10/07/2024, unless sooner terminated or extended by written notice to Intertek Testing Services and the Federal Communications Commission. This is to advise that we are in full compliance with the Anti-Drug Abuse Act. The applicant is not subject to a denial of federal benefits pursuant to Section 5301 of the Anti-Drug Act of 1988, 21 U.S.C. 862, and no party to the application is subject to a denial of federal benefits pursuant to that section. If you have any questions or comments, please do not hesitate to contact me. Sincerely, Raymond M Zackowski Principal Systems Engineer Neuros Medical, Inc. Email: [email protected]
NeurosMedical.com Attention: Application Examiner Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 Re: Applicant Authorization Signature Applicant FRN: 0033629213 To whom it may concern, I Nemath Syed-Shah authorize Raymond Zackowski to sign the application documents for the following FCC ID’s: 2BATK601, 2BATK603, 2BATK604, 2BATK606. Thank you for your attention to this matter. Sincerely, Nemath Syed-Shah Sr. Manager, R&D Neuros Medical 26800 Aliso Viejo Pkwy, Suite 250 Aliso Viejo, CA 92656
External Photos Insert a sufficient number of photographs to clearly show the exterior appearance, the construction, the component placement on the chassis, and the chassis assembly per Section 2.1033. Programmer Wand: Programmer Wand, External Photo Front Programmer Wand External Photo, Back, with FDA Study Labelling Programmer Wand External Photo, Left side Programmer Wand External Photo, top side, looking down front side. Programmer Wand External Photo, Right side. Programmer Wand External Photo, Right side, looking up front showing USB cable coming out of the Programmer wand.
System Name: Altius System Unit Name: Altius Programmer Wand Label Description: Altius Programmer Wand Product Label Label Description: Altius Patient Controller Product with Label
Internal Photos A sufficient number of photographs to clearly show construction, component placement, chassis assembly per Section 2.1033. Includes All but Altius IPG. Altius Programmer Wand Internal Photos: Programmer Wand Internal Photo, Front of PCBA Programmer Wand Internal Photo, Back of PCBA Programmer Wand Internal Photo, Coils Programmer Wand Internal Photo, Case Disassembled
Neuro Medical, Inc. SAR Test Exclusion Report SCOPE OF WORK SAR Test Exclusion Report of the Wireless Charger of the Altius system REPORT NUMBER 105246853BOX-011d.1 ISSUE DATE [REVISED DATE] July 26, 2023 July 24, 2024 DOCUMENT CONTROL NUMBER Non-Specific Radio Report Shell Rev. October 2022 © 2022 INTERTEK Non-Specific Radio Report Shell Rev. October 2022 Page 2 of 8 Client: Neuros Medical, Inc. – Model: Wireless Charger of the Altius system SAR TEST EXCLUSION REPORT (FULL COMPLIANCE) Report Number: 105246853BOX-011d.1 Project Number: G105246853 Report Issue Date: July 26, 2023 Report Revision Date: July 24, 2024 Model(s) Tested: Wireless Charger of the Altius system Model(s) Partially Tested: None Model(s) Not Tested but declared equivalent by the client: None Standards: KDB 447498 D01 General RF Exposure Guidance v06 Tested by: Client: Intertek 70 Codman Hill Road Boxborough, MA 01719 USA Neuros Medical Inc 35010 Chardon Road, Suite 210 Willoughby, OH 44094 USA Report prepared by Report reviewed by Kouma Sinn / Senior EMC Staff Engineer Vathana Ven / Senior EMC Staff Engineer This report is for the exclusive use of Intertek's Client and is provided pursuant to the agreement between Intertek and its Client. Intertek's responsibility and liability are limited to the terms and conditions of the agreement. Intertek assumes no liability to any party, other than to the Client in accordance with the agreement, for any loss, expense or damage occasioned by the use of this report. Only the Client is authorized to permit copying or distribution of this report and then only in its entirety. Any use of the Intertek name or one of its marks for the sale or advertisement of the tested material, product or service must first be approved in writing by Intertek. The observations and test results in this report are relevant only to the sample tested. This report by itself does not imply that the material, product, or service is or has ever been under an Intertek certification program. Intertek Report Number: 105246853BOX-011d.1 Issued: 07/26/2023 Revised: 07/24/2024 Non-Specific Radio Report Shell Rev. October 2022 Page 3 of 8 Client: Neuros Medical, Inc. – Model: Wireless Charger of the Altius system Table of Contents 1 Introduction and Conclusion .............................................................................................................. 4 2 Test Summary ...................................................................................................................................... 4 3 Client Information ................................................................................................................................ 5 4 Description of Equipment Under Test and Variant Models ............................................................. 5 5 SAR Test Exclusion ............................................................................................................................. 6 6 Revision History ................................................................................................................................... 8 Intertek Report Number: 105246853BOX-011d.1 Issued: 07/26/2023 Revised: 07/24/2024 Non-Specific Radio Report Shell Rev. October 2022 Page 4 of 8 Client: Neuros Medical, Inc. – Model: Wireless Charger of the Altius system 1 Introduction and Conclusion The tests indicated in section 2.0 were performed on the product constructed as described in section 4.0. The remaining test sections are the verbatim text from the actual data sheets used during the investigation. These test sections include the test name, the specified test Method, a list of the actual Test Equipment Used, documentation Photos, Results and raw Data. No additions, deviations, or exclusions have been made from the standard(s) unless specifically noted. Based on the results of our investigation, we have concluded the product tested complies with the requirements of the standard(s) indicated. The results obtained in this test report pertain only to the item(s) tested. Intertek does not make any claims of compliance for samples or variants which were not tested. 2 Test Summary Section Test full name Result 3 Client Information -- 4 Description of Equipment Under Test and Variant Models -- 5 SAR Test Exclusion KDB 447498 D01 General RF Exposure Guidance v06 Pass 6 Revision History -- Intertek Report Number: 105246853BOX-011d.1 Issued: 07/26/2023 Revised: 07/24/2024 Non-Specific Radio Report Shell Rev. October 2022 Page 5 of 8 Client: Neuros Medical, Inc. – Model: Wireless Charger of the Altius system 3 Client Information This EUT was tested at the request of: Client: Neuros Medical, Inc. 35010 Chardon Road, Suite 210 Willoughby, OH 44094 USA Contact: Raymond Zackowski Telephone: 4805161383 Email: [email protected] 4 Description of Equipment Under Test and Variant Models Manufacturer: Neuros Medical, Inc. 35010 Chardon Road, Suite 210 Willoughby, OH 44094 USA Description of Equipment Under Test (provided by client) The Altius system is intended to treat residual limb pain and phantom pain in lower limb amputees. The Implanted system consists of an implanted IPG (Implantable Pulse Generator) and one or two cuff electrodes. The non-implantable system consists of a patient controller for activating an on demand therapy setting, a Battery charger intended for recharging the IPG, and a programmer system which consists of a programmer application software running on an off the shelf laptop, and a programmer which is used to communicate with the IPG. Variant Models: The following variant models were not tested as part of this evaluation and are not eligible for certification; but have been identified by the manufacturer as being electrically identical models, depopulated models, or with reasonable similarity to the model(s) tested. Intertek does not make any claims of compliance for samples or variants which were not tested. None Intertek Report Number: 105246853BOX-011d.1…
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Page 1 of 28 NEUROS MEDICAL INC TEST REPORT SCOPE OF WORK EMC TESTING – THE ALTIUS SYSTEM (IMPLANTABLE) REPORT NUMBER 105246853BOX-011.FCC ISSUE DATE September 16, 2024 DOCUMENT CONTROL NUMBER IEC 60601-1-2 ed 4.1 EMC Report Shell Rev. October 2022 © 2022 INTERTEK IEC 60601-1-2 ed 4.1 EMC Report Shell Rev. October 2022 Page 2 of 28 Page 2 of 28 Neuros Medical INC. The Altius System EMC TEST REPORT (FULL COMPLIANCE) Report Number: 105246853BOX-011.FCC Project Number: G105246853 Report Issue Date: 09/16/2024 Model(s) Tested: THE ALTIUS SYSTEM Model(s) Partially Tested: None Model(s) Not Tested but declared equivalent by the client: None Standards: FCC 47CFR Part 15 Subpart B: 01/2023 FCC 47CFR Part 15.209 Subpart C: 01/2023 Tested by: Client: Intertek 70 Codman Hill Road Boxborough, MA 01719 USA Neuros Medical Inc 35010 Chardon Road, Suite 210 Willoughby, OH 44094 USA Report prepared by: Report reviewed by: Kouma Sinn / Sr. EMC Staff Engineer Vathana Ven / Sr. EMC Staff Engineer This report is for the exclusive use of Intertek's Client and is provided pursuant to the agreement between Intertek and its Client. Intertek's responsibility and liability are limited to the terms and conditions of the agreement. Intertek assumes no liability to any party, other than to the Client in accordance with the agreement, for any loss, expense or damage occasioned by the use of this report. Only the Client is authorized to permit copying or distribution of this report and then only in its entirety. Any use of the Intertek name or one of its marks for the sale or advertisement of the tested material, product or service must first be approved in writing by Intertek. The observations and test results in this report are relevant only to the sample tested. This report by itself does not imply that the material, product, or service is or has ever been under an Intertek certification program. Intertek Report Number: 105246853BOX-011.FCC Issued: 09/16/2024 IEC 60601-1-2 ed 4.1 EMC Report Shell Rev. October 2022 Page 3 of 28 Neuros Medical INC. The Altius System Table of Contents 1 Introduction and Conclusion .............................................................................................................. 4 2 Test Summary ...................................................................................................................................... 4 3 Client Information ................................................................................................................................ 5 4 Description of Equipment Under Test and Variant Models ............................................................. 5 5 System Setup and Method .................................................................................................................. 6 6 Radiated Emissions ............................................................................................................................. 8 7 Revision History ................................................................................................................................. 28 Intertek Report Number: 105246853BOX-011.FCC Issued: 09/16/2024 IEC 60601-1-2 ed 4.1 EMC Report Shell Rev. October 2022 Page 4 of 28 Neuros Medical INC. The Altius System 1 Introduction and Conclusion The tests indicated in section 2.0 were performed on the product constructed as described in section 4.0. The remaining test sections are the verbatim text from the actual data sheets used during the investigation. These test sections include the test name, the specified test Method, a list of the actual Test Equipment Used, documentation Photos, Results and raw Data. No additions, deviations, or exclusions have been made from the standard(s) unless specifically noted in the relevant section of this report. Based on the results of our investigation, we have concluded the product tested complies with the requirements of the standard(s) indicated. The results obtained in this test report pertain only to the item(s) tested. Intertek does not make any claims of compliance for samples or variants which were not tested. 2 Test Summary Section Test full name Result 3 Client Information -- 4 Description of Equipment Under Test and Variant Models -- 5 System Setup and Method -- 6 Radiated Emissions FCC 47CFR Part 15 Subpart B: 01/2023 FCC 47CFR Part 15.209 Subpart C: 01/2023 Pass Intertek Report Number: 105246853BOX-011.FCC Issued: 09/16/2024 IEC 60601-1-2 ed 4.1 EMC Report Shell Rev. October 2022 Page 5 of 28 Neuros Medical INC. The Altius System 3 Client Information This EUT was tested at the request of: Client: Neuros Medical Inc 35010 Chardon Road, Suite 210 Willoughby, OH 44094 USA Contact: Raymond Zackowski Telephone: 4805161383 Email: [email protected] 4 Description of Equipment Under Test and Variant Models Manufacturer: Neuros Medical Inc 35010 Chardon Road, Suite 210 Willoughby, OH 44094 USA Equipment Under Test Description Manufacturer Model Number Serial Number Patient Controller Neuros Medical FG-604-000 0331, 0332,0333 Programmer Wand Neuros Medical FG-606-000 0765, 0757, 0761 Altius IPG Neuros Medical FG-601-000 0326,0383,0388 Receive Date: 01/10/2023 Received Condition: Good Type: Production Description of Equipment Under Test (provided by client) The equipment under test is a patient controller and programmer wand that are intended to be used with the Altius system for treating residual limb pain and phantom pain in lower limb amputees. The Implanted system consists of an implanted IPG (Implantable Pulse Generator) and one or two cuff electrodes. Equipment Under Test Power Configuration Rated Voltage Rated Current Rated Frequency Number of Phases 5VDC USB N/A DC N/A Operating modes of the EUT: No. Descriptions of EUT Exercising 1 Patient controller continuous transmitting at 20 kHz 2 Programmer wand continuous transmitting at 20 kHz. Altius IPG transmitting at 19kHz. Software used by the EUT: No. Descriptions of EUT Exercising 1 P…
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Page 1 of 26 NEUROS MEDICAL INC TEST REPORT SCOPE OF WORK EMC TESTING – ALTIUS WIRELESS CHARGER REPORT NUMBER 105246853BOX-017F ISSUE DATE [REVISED DATE] 09/18/2023 Original issue DOCUMENT CONTROL NUMBER Non-Specific Radio Report Shell Rev. October 2022 © 2022 INTERTEK Non-Specific Radio Report Shell Rev. October 2022 Page 2 of 26 Neuros Medical INC. Altius Wireless Charger EMC TEST REPORT (FULL COMPLIANCE) Report Number: 105246853BOX-017F Project Number: G105246853 Report Issue Date: 09/18/2023 Model(s) Tested: FG-603-000 Model(s) Partially Tested: None Model(s) Not Tested but declared equivalent by the client: None Standards: FCC Part 15 Subpart C (15.209): 01/2023 FCC Part 15 Subpart B: 01/2023 FCC Part 18: 01/2023 RSS-102 Issue 5: 03/2015 ISED SPR-002 Issue 2: 10/2022 Supplementary Procedure for Assessing Compliance with RSS-102 Nerve Stimulation Exposure Limits Tested by: Client: Intertek 70 Codman Hill Road Boxborough, MA 01719 USA Neuros Medical Inc 35010 Chardon Road, Suite 210 Willoughby, OH 44094 USA Report prepared by: Report reviewed by: Vathana Ven/Senior Staff Engineer, EMC Kouma Sinn/Senior Staff Engineer, EMC This report is for the exclusive use of Intertek's Client and is provided pursuant to the agreement between Intertek and its Client. Intertek's responsibility and liability are limited to the terms and conditions of the agreement. Intertek assumes no liability to any party, other than to the Client in accordance with the agreement, for any loss, expense or damage occasioned by the use of this report. Only the Client is authorized to permit copying or distribution of this report and then only in its entirety. Any use of the Intertek name or one of its marks for the sale or advertisement of the tested material, product or service must first be approved in writing by Intertek. The observations and test results in this report are relevant only to the sample tested. This report by itself does not imply that the material, product, or service is or has ever been under an Intertek certification program. Intertek Report Number: 105246853BOX-017F Issued: 09/18/2023 Non-Specific Radio Report Shell Rev. October 2022 Page 3 of 26 Neuros Medical INC. Altius Wireless Charger Table of Contents 1 Introduction and Conclusion .............................................................................................................. 4 2 Test Summary ...................................................................................................................................... 4 3 Client Information ................................................................................................................................ 5 4 Description of Equipment Under Test and Variant Models ............................................................. 5 5 System Setup and Method .................................................................................................................. 7 6 Radiated Emissions and Human RF Exposure ................................................................................. 8 7 Occupied Bandwidth ......................................................................................................................... 23 8 Revision History ................................................................................................................................. 26 Intertek Report Number: 105246853BOX-017F Issued: 09/18/2023 Non-Specific Radio Report Shell Rev. October 2022 Page 4 of 26 Neuros Medical INC. Altius Wireless Charger 1 Introduction and Conclusion The tests indicated in section 2.0 were performed on the product constructed as described in section 4.0. The remaining test sections are the verbatim text from the actual data sheets used during the investigation. These test sections include the test name, the specified test Method, a list of the actual Test Equipment Used, documentation Photos, Results and raw Data. No additions, deviations, or exclusions have been made from the standard(s) unless specifically noted in the relevant section of this report. Based on the results of our investigation, we have concluded the product tested complies with the requirements of the standard(s) indicated. The results obtained in this test report pertain only to the item(s) tested. Intertek does not make any claims of compliance for samples or variants which were not tested. 2 Test Summary Section Test full name Result 3 Client Information -- 4 Description of Equipment Under Test and Variant Models -- 5 System Setup and Method -- 6 Radiated Emissions and Human RF Exposure FCC Part 15 Subpart C (15.209): 01/2023, FCC Part 15 Subpart B: 01/2023, FCC Part 18: 01/2023, RSS-102 Issue 5: 03/2015, ISED SPR-002 Issue 2: 10/2022 Pass 7 Occupied Bandwidth FCC Part 15, Subpart C Pass 8 AC Mains…
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| # | Rule Parts | Frequency Range | Power Output |
|---|---|---|---|
| 1 | 15C | 0.02 MHz - 0.02 MHz | - |

Altius IPG
Equipment Class
DCD - Part 15 Low Power Transmitter Below 1705 kHz
Altius Patient Controller
Equipment Class
DCD - Part 15 Low Power Transmitter Below 1705 kHz
Altius Battery Charger
Equipment Class
DCD - Part 15 Low Power Transmitter Below 1705 kHz