LF5P7850NImplantable Neurostimulator

M028929C001_05_22_2023_MM_CH edit - 05JUN23 - CH_MM working June 19, 2023 10:11 AM 9” x 7” inches (228.6 mm x 177.8 mm) Medtronic Confidential Clinician_Manual_Tablet.indd Template version 1: 07_19_2022 M028929C001 Rev A 2023-06-15 Clinician Therapy and Programming Guide for the InterStim T™ System Tibial Neuromodulation Therapy Model P7850N InterStim T Neurostimulator Model P720R1 Recharger Model CD9000A Recharger dock Model P742A1 Ankle band Model P7A2C11 InterStim T Clinician application version 1.0 Not For Human USE Spectrum Authority Only. M028929C001_05_22_2023_MM_CH edit - 05JUN23 - CH_MM working June 19, 2023 10:11 AM 9” x 7” inches (228.6 mm x 177.8 mm) Medtronic Confidential Clinician_Manual_Tablet.indd Template version 1: 07_19_2022 M028929C001 Rev A 2023-06-15 Not For Human USE Spectrum Authority Only. M028929C001_05_22_2023_MM_CH edit - 05JUN23 - CH_MM working June 19, 2023 10:11 AM 9” x 7” inches (228.6 mm x 177.8 mm) Medtronic Confidential Clinician_Manual_Tablet.indd Template version 1: 07_19_2022 M028929C001 Rev A 2023-06-15 3 English 2023-06-15 InterStim T™ Medtronic and the Medtronic logo are trademarks of Medtronic. ™* Third-party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company. The Bluetooth®* word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Medtronic is under license. Android™* is a trademark of Google LLC. Wi-Fi™* is a trademark of Wi-Fi Alliance®. Medtronic products may be protected by US Patents listed at: www. medtronic.com/patents. Not For Human USE Spectrum Authority Only. M028929C001_05_22_2023_MM_CH edit - 05JUN23 - CH_MM working June 19, 2023 10:11 AM 9” x 7” inches (228.6 mm x 177.8 mm) Medtronic Confidential Clinician_Manual_Tablet.indd Template version 1: 07_19_2022 M028929C001 Rev A 2023-06-15 4 English 2023-06-15 InterStim T™ Symbols Symbols Explanation of symbols on product or package labeling Rx only Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Class II equipment Consult instructions for use Consult electronic instructions for use at this website Date of manufacture Direct current Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See http://recycling.medtronic.com for instructions on proper disposal of product. Do not resterilize Do not reuse ISO 15223-1 [5.2.8] Do not use if package is damaged and consult instructions for use Double sterile barrier system Follow instructions for use For USA audiences only IEC 60601-1/EN60601-1, Type BF Equipment (IEC 60417-5333) Implantable neurostimulator Keep dry Lot number Manufacturer Magnetic Resonance (MR) Conditional Medical device Not For Human USE Spectrum Authority Only. M028929C001_05_22_2023_MM_CH edit - 05JUN23 - CH_MM working June 19, 2023 10:11 AM 9” x 7” inches (228.6 mm x 177.8 mm) Medtronic Confidential Clinician_Manual_Tablet.indd Template version 1: 07_19_2022 M028929C001 Rev A 2023-06-15 5 English 2023-06-15 InterStim T™ Symbols Model number ASTM F2503 [7.4.10] Magnetic Resonance (MR) Unsafe Open here Package contents Product documentation Reorder number Serial number Single sterile barrier system Sterilized using ethylene oxide This product meets the basic safety and essential performance requirements indicated in the IP21 conditioning test. This product meets the basic safety and essential performance requirements indicated in the IP22 conditioning test. Unique device identifier Use by Not For Human USE Spectrum Authority Only. M028929C001_05_22_2023_MM_CH edit - 05JUN23 - CH_MM working June 19, 2023 10:11 AM 9” x 7” inches (228.6 mm x 177.8 mm) Medtronic Confidential Clinician_Manual_Tablet.indd Template version 1: 07_19_2022 M028929C001 Rev A 2023-06-15 6 English 2023-06-15 InterStim T™ Symbols Information available for the system: The clinician therapy and programming guide provides therapy information about indications, contraindications, warnings, precautions, adverse events, patient selection, individualization of treatment, and component disposal. The clinician therapy and programming guide also provides product information about the system and its components including device description, package contents, device specifications, product-specific warnings and precautions, and instructions for use, maintenance information, information about battery longevity calculations, and battery characteristics. MRI guidelines provide information about any MRI conditions and MRI-specific contraindications, warnings, and precautions for MRI scans with the neuromodulation system. For the MRI Guidelines for the InterStim T Neurostimulator, search by neurostimulator model number at www.medtronic.com/mri. The implant manual and pocket dissector manual provide device descriptions, package contents, device specifications, product specific warnings and precautions, instructions for use, and component disposal. The clinical summary provides information about the clinical study results for the neurostimulation system. Refer to the literature provided by the clinician tablet manufacturer for information regarding wireless use. Not For Human USE Spectrum Authority Only. M028929C001_05_22_2023_MM_CH edit - 05JUN23 - CH_MM working June 19, 2023 10:11 AM 9” x 7” inches (228.6 mm x 177.8 mm) Medtronic Confidential Clinician_Manual_Tablet.indd Template version 1: 07_19_2022 M028929C001 Rev A 2023-06-15 7 English 2023-06-15 InterStim T™ Table of contents Symbols ........................................................................4 Table of contents ........................................................7 Introduction ..............................................................10 About this guide ...................................................................10 About InterStim T therapy ......................................10 Indications ......................................…

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

M028929C001_05_22_2023_MM_CH edit - 05JUN23 - CH_MM working June 19, 2023 10:11 AM 9” x 7” inches (228.6 mm x 177.8 mm) Medtronic Confidential Clinician_Manual_Tablet.indd Template version 1: 07_19_2022 M028929C001 Rev A 2023-06-15 37 English 2023-06-15 InterStim T™ Follow-up status check and programming Adjust therapy details On the dashboard, information about the stimulation and schedule settings can be found under the Therapy Details section. Figure 29. Therapy Details: Stimulation and Schedule panels To adjust programmed stimulation settings: 1. Tap EDIT found in the upper right-hand corner of the Stimulation panel. Note: Adjusting stimulation parameters requires that stimulation be turned on. 2. Adjust settings as needed. 3. Tap DONE to save the changes and return to the dashboard. To adjust therapy schedule settings: 1. Tap EDIT found in the upper right-hand corner of the Schedule panel. 2. Adjust settings as needed. 3. Tap SAVE to save the changes and return to the dashboard. View therapy adherence Figure 30. Usage Insights: Therapy Adherence panel On the dashboard, the Therapy Adherence panel (Figure 30) shows information about therapy adherence (as a percentage determined by the number of sessions completed ÷ total number of sessions initiated) over the last 6 months. A therapy session is considered completed if the INS is on for the full therapy length. A therapy session that is partially completed is considered a skipped session in the therapy adherence calculation. The date and time of the last and next therapy sessions is also shown in this panel. Note: Therapy adherence information is not available for patients that receive constant stimulation. To display therapy adherence information on the dashboard: • Tap DOWNLOAD USAGE DATA (Figure 28- ). • Tap VIEW DETAILS to open the Therapy History screen to see more detailed information. Not For Human USE Spectrum Authority Only. M028929C001_05_22_2023_MM_CH edit - 05JUN23 - CH_MM working June 19, 2023 10:11 AM 9” x 7” inches (228.6 mm x 177.8 mm) Medtronic Confidential Clinician_Manual_Tablet.indd Template version 1: 07_19_2022 M028929C001 Rev A 2023-06-15 38 English 2023-06-15 InterStim T™ Follow-up status check and programming The Therapy History screen (Figure 31) provides the status of each patient session, grouped monthly, and provides details based on therapy type, including: • Date of session • Time session started • Amplitude adjustment events • Session length • Delivery amount (length of delivered therapy ÷ length of scheduled therapy) Figure 31. Therapy History screen The data are formatted into a vertically scrollable table with each row representing an individual scheduled therapy session. Data can be filtered by using the Date Range selection. Note: If the INS has a low battery event or an INS power-on reset occurs, collection of therapy adherence data could be interrupted. See “Clinician app, tablet, and recharger scenarios”, page 53, for more information. View recharge details Figure 32. Usage Insights: Recharge panel On the dashboard, the Recharge panel displays the current neurostimulator battery level and charging status. To see more details about recharge tap VIEW DETAILS to open the Recharge Details screen (Figure 33). The Recharge Details graph displays the following information for the last 10 recharging sessions: • Neurostimulator ba ttery percentage before and after each recharging session • Quality of recharge coupling to the INS • Recharge time Not For Human USE Spectrum Authority Only. M028929C001_05_22_2023_MM_CH edit - 05JUN23 - CH_MM working June 19, 2023 10:11 AM 9” x 7” inches (228.6 mm x 177.8 mm) Medtronic Confidential Clinician_Manual_Tablet.indd Template version 1: 07_19_2022 M028929C001 Rev A 2023-06-15 39 English 2023-06-15 InterStim T™ Follow-up status check and programming Figure 33. Recharge Details screen A summary of the metrics is also provided on the right side of the screen. This information can be used to assess and guide the patient on the future recharging needs and coupling status, if needed. Check recharge interval From the dashboard, you can check how the current programmed settings will affect the recharge interval. The recharge interval is the time it takes a fully charged INS to reach a critically low battery level. To guide your patient on how frequently to recharge their INS and help avoid therapy disruptions, use the “suggested recharge frequency” on the recharge interval results (Figure 36). While a patient could wait until the “fully charged implant battery cycle” time period to recharge the INS, recharging based on the “suggested recharge frequency” will help avoid therapy disruptions. To check recharge interval: 1. Tap CAL CULATE found in the Recharge panel on the dashboard screen (Figure 34) to open the Recharge Interval screen. Figure 34. Recharge CALCULATE button 2. Tap CALCULATE on the Recharge Interval screen (Figure 35). Figure 35. Recharge Interval screen 3. Stimulation will be turned on during the recharge interval calculation. Once the calculation is complete, the results will be displayed to the screen (Figure 36). Not For Human USE Spectrum Authority Only. M028929C001_05_22_2023_MM_CH edit - 05JUN23 - CH_MM working June 19, 2023 10:11 AM 9” x 7” inches (228.6 mm x 177.8 mm) Medtronic Confidential Clinician_Manual_Tablet.indd Template version 1: 07_19_2022 M028929C001 Rev A 2023-06-15 40 English 2023-06-15 InterStim T™ Follow-up status check and programming 1 schedule2 schedules Figure 36. Recharge interval results for 1 or 2 schedules (examples) 4. Tap DONE to close the Recharge Interval screen and return to the dashboard. Notes: • The measur ed data are not saved or displayed on the dashboard. Tapping DONE will clear the results after every check. • The displayed recharge interval is an estimate, based on the current stimulation settings and therapy schedule parameters. See “Estimating recharge interval”, page 71. • Actual battery longevity will depend on a…

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

CFR 47 §2.911 (d)(7) Agent Designation Attestation Date: 06-14-2023 FCC ID: LF5P7850N To: Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 USA Medtronic, Inc. (LF5) (“the applicant”) as required by section 2.911(d)(7), designates the following agent, located in the United States, for purposes of acting as the applicant’s agent for service of process. The applicant acknowledges that they will maintain an agent for no less than one year after the grantee has terminated 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 agent information changes. U. S. Agent Information: Contact Person: Guillaume Girard Company name: Medtronic, Inc. Company Address: 8200 Coral Sea Street NE Mail Stop MVS11, Mounds View, MN 55112 Email: [email protected] FRN: 0008250839 Sincerely yours, Guillaume Girard Title Distinguished Regulatory Affairs Advisor Medtronic, Inc. 8200 Coral Sea Street NE Mail Stop MVS11, Mounds View, MN 55112

CFR 47 §2.911 (d)(5) Attestation Date: 06-14-2023 FCC ID: LF5P7850N To: Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 USA 1. Medtronic, Inc. (“the applicant”) certifies that 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. 2. Medtronic, Inc. (“the applicant”) 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 an affiliate or subsidiary of an entity identified on the Covered List. Sincerely yours, Guillaume Girard Title Distinguished Regulatory Affairs Advisor Medtronic, Inc. 8200 Coral Sea Street NE Mail Stop MVS11, Mounds View, MN 55112 [email protected]

Hyundai C-Tech, Inc. dba HCT America, Inc. 1726 Ringwood Avenue San Jose, CA 95131 TEL: +1.510.933.8848 || Fax: +1.510.933.8849 Page 1 of 1 07-20-2023 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046, USA FCC Agent Authorization Letter Applicant Medtronic, Inc. Model Name P7850N Product Description Implantable Neurostimulator FCC ID LF5P7850N We, the undersigned, hereby authorize Hyundai C-Tech, Inc. dba HCT America Inc. to act on our behalf in all manners relating to application for equipment authorization, including signing of all documents relating to these matters. Any and all acts carried out by Hyundai C-Tech, Inc. dba HCT America Inc. on our behalf shall have the same effect as acts of our own. We, the undersigned, hereby certify that we are not 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. 853(a). We recognize that we are still responsible for the terms and conditions outlined in the HCT America Client Services Agreement. This authorization is valid until further written notice from the applicant. Sincerely, Guillaume Girard Title Distinguished Regulatory Affairs Advisor Medtronic, Inc. 8200 Coral Sea Street NE Mail Stop MVS11, Mounds View, MN 55112 [email protected]

Hyundai C-Tech, Inc. dba HCT America, Inc. 1726 Ringwood Avenue San Jose, CA 95131 TEL: +1.510.933.8848 || Fax: +1.510.933.8849 Page 1 of 2 09-07-2023 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046, USA FCC Confidentiality Request Letter Applicant Medtronic, Inc. Model Name P7850N FCC ID LF5P7850N Pursuant to the provisions of Section 0.457 and 0.459 of the commission’s rules (47 CFR 0.457, 0.459), we are requesting the Commission to withhold the following attachments as confidential document from public disclosure indefinitely. • Block Diagram • Schematics • Technical Operation Description • Internal Photos (implantable device) The above-mentioned documents contain detailed system and equipment description that are considered propriety information in operation of the equipment. The public disclosure of the above documents might be harmful to our company and would give competitors an unfair advantage in the market. Circuit board and internal components of the P7850N are enclosed in a welded titanium enclosure and implanted in a human body (KDB 726920 3a1). Device model P7850N is implanted into the human body therefore not accessible to the public and can only be access by a health care professional (KDB 726920 3a2). Internal picture is controlled by Medtronic for distribution and mark confidential. NDA template is provided per KDB 72692 if required. In addition to the above mentioned documents, pursuant to Public Notice DA 04-1705 of the Commission’s policy, in order to comply with marketing regulations in 47 CFR §2.803 ad the importation rules in 47 CFR §2.1204 while ensuring that business sensitive information remains confidential until the actual marketing of newly authorized devices. We request that the Commission to grant Short-Term Confidentiality on the following attachments for 180 days after the grant as outlined in Public Notice DA 04-1705. • External Photos • Test Setup Photos • User’s Manual Sincerely, Guillaume Girard Hyundai C-Tech, Inc. dba HCT America, Inc. 1726 Ringwood Avenue San Jose, CA 95131 TEL: +1.510.933.8848 || Fax: +1.510.933.8849 Page 2 of 2 Title Distinguished Regulatory Affairs Advisor Medtronic, Inc. 8200 Coral Sea Street NE Mail Stop MVS11, Mounds View, MN 55112 [email protected]

Hyundai C-Tech, Inc. dba HCT America, Inc. 1726 Ringwood Avenue San Jose, CA 95131 TEL: +1.510.933.8848 || Fax: +1.510.933.8849 Page 1 of 1 07-27-2023 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046, USA Cover Letter We would like to apply for FCC New Application: Applicant Medtronic, Inc. Model Name(s) P7850N Product Type Implantable Neurostimulator FCC ID LF5P7850N Please find enclosed our Claim Report, which includes the following: • Agent Authorization Letter • Antenna Specification / Data Sheet • Confidential Request Letter • ID Label and Location Photograph • Product External and Internal Photos • RF Test Report (if applicable) • Block Diagram, Schematics, and Operational Description • User’s Manual(s) Should you have any questions, please contact us. Sincerely, ______________________ Jenny Huang HCT America, Inc. [email protected]

1 / 4 This document may not be copied or reproduced (reprinted) without written consent by Hyundai C-Tech, Inc. dba HCT America, Inc. Hyundai C-Tech, Inc. dba HCT America, Inc., 1726 Ringwood Avenue, San Jose, CA 95131, USA. TEL: +1-510-933-8848 FAX: +1-510-933-8849 APPENDIX B.1 PHOTOGRAPHS OF EUT EXTERNAL PHOTOS Applicant Medtronic Inc. Model Name P7850N FCC ID LF5P7850N IC ID 3408D-P7850N Reference Test Report No.: HA221024-MED-007-R01 2 / 4 This document may not be copied or reproduced (reprinted) without written consent by Hyundai C-Tech, Inc. dba HCT America, Inc. Hyundai C-Tech, Inc. dba HCT America, Inc., 1726 Ringwood Avenue, San Jose, CA 95131, USA. TEL: +1-510-933-8848 FAX: +1-510-933-8849 Front View Rear View 3 / 4 This document may not be copied or reproduced (reprinted) without written consent by Hyundai C-Tech, Inc. dba HCT America, Inc. Hyundai C-Tech, Inc. dba HCT America, Inc., 1726 Ringwood Avenue, San Jose, CA 95131, USA. TEL: +1-510-933-8848 FAX: +1-510-933-8849 Left Side View Right Side View 4 / 4 This document may not be copied or reproduced (reprinted) without written consent by Hyundai C-Tech, Inc. dba HCT America, Inc. Hyundai C-Tech, Inc. dba HCT America, Inc., 1726 Ringwood Avenue, San Jose, CA 95131, USA. TEL: +1-510-933-8848 FAX: +1-510-933-8849 Top View Bottom View

P7850N Communications Regulation Reference Sheet Manufacturer Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 USA www.medtronic.com Tel. +1-763-505-5000 Authorized Representative in the European Community Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel. +31-45-566-8000 Europe/Africa/Middle East Headquarters Medtronic International Trading Sàrl Route du Molliau 31 Case Postale 84 CH - 1131 Tolochenaz Switzerland www.medtronic.eu Tel. +41-21-802-7000 Asia-Pacific Medtronic International Ltd. 50 Pasir Panjang Road #04-51 Mapletree Business City Singapore 117384 Singapore Tel. +65-6870-5510 Communications Regulations The following is a list of communications regulations that apply to the Model P7850N. United States Compliance FCC ID: LF5P7850N This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received , i ncluding interference that may cause undesired operation. IMPORTANT: Changes or modifications to this product not authorized by Medtronic, Inc., could void the FCC Certification and negate your authority to operate this product. Canada Compliance IC: 3408D-P7850N This device contains licence- exempt transmitter(s)/ receiver(s) that comply with Innovation, Science and Economic Development Canada’s licence-exempt RSS(s). Operation is subject to the following two conditions: (1) This device may not cause interference. (2) This device must accept any interference, including interference that may cause undesired operation of the device. L’émetteur/récepteur exempt de licence contenu dans le présent appareil est conforme aux CNR d’Innovation, Sciences et Développement économique Canada applicables aux appareils radio exempts de licence. L’exploitation est autorisée aux deux conditions suivantes : 1) L’appareil ne doit pas produire de brouillage; 2) L’appareil doit accepter tout brouillage radioélectrique subi, mê me si le brouillage est susceptible d’en compromettre le fonctionnement. Taiwan Compliance CCALXXXXXXXXXX 經型式認證合格之低功率射 頻電 機，非經許可，公司、商號或使 用者均不得擅自變更頻率、加大 功 率或變 更原設計之特性及功 能。低功率射頻電機之使用不得 影響飛航安全及干擾合法通信； 經發現 有 干擾現象時，應立即 停用，並改善至無干擾時方得繼 續使用。前項合法通信，指依電 信法規定作 業之無線電通信。 低功率射頻電機須忍受合法通信 或工業、科學及醫療用電波輻射 性電機設備之干擾. According to "Administrative Regulations on Low Power Radio Waves Radiated Devices" Without permission gr anted by the NCC, any company, enterprise, or user is not allowed to change frequency, enhance transmitting power or alter or iginal characteristic as well as performance to an approved low power radio-frequency devices. The low power radio- frequency devices shall not influence aircraft security and interfere legal communications; If found, the user shall cease operating immediately until no interference is achieved. The said legal communications means radio communications is operated in compliance with the Te lecommunications Act. The low power radio-frequency devices must be susceptible with the interference from legal communications or ISM radio wave radiated devices. *M985337A002* © Medtronic 2021 All Rights Reserved M985337A002 Rev A 2021-07-01

RF EXPOSURE REPORT F C C APPLICANT Medtronic Inc MODEL NAME P7850N FCC ID LF5P7850N REPORT NUMBER HA221024-MED-007-R02-1 Report No.: HA221024-MED-007-R02-1 1 / 8 This document may not be copied or reproduced (reprinted) without written consent by Hyundai C-Tech, Inc. dba HCT America, Inc. Hyundai C-Tech, Inc. dba HCT America, Inc., 1726 Ringwood Avenue, San Jose, CA 95131, USA TEL: +1-510-933-8848 FAX: +1-510-933-8849 T E S T R E P O R T Date of Issue August 17, 2023 Test Site Hyundai C-Tech, Inc. dba HCT America, Inc. 1726 Ringwood Ave, San Jose, CA 95131, USA Applicant Medtronic Inc. Applicant Address 710 Medtronic Parkway N.E., Minneapolis, MN 55432, U.S.A. FCC ID LF5P7850N Model Name P7850N EUT Type Ultra Low Power Active Medical Implant (ULP-AMI) FCC Classification Part15 Low Power Transmitter Below 1705 kHz (DCD) FCC Rule Part(s) Part 1 (§1.1310 / §1.1307) Test Procedure KDB 447498 D04 v01 The device bearing the trade name and model specified above, has been shown to comply with the applicable technical standards as indicated in the measurement report and was in accordance with the procedures specified in §2.947. The results in this report apply only to the product which was tested. Other similar equipment will not necessarily produce the same results due to production tolerance and measurement uncertainties. I attest to the accuracy of data. All measurements reported herein were performed by me or were made under my supervision and are correct to the best of my knowledge and belief. I assume full responsibility for the completeness of these measurements and vouch for the qualifications of all persons taking them. Hyundai C-Tech, Inc. dba HCT America, Inc. certifies that no party to application has been denied the FCC benefits pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C 862 Tested By Reviewed By Tim Lee Yongsoo Park Test Engineer Technical Manager Report No.: HA221024-MED-007-R02-1 2 / 8 This document may not be copied or reproduced (reprinted) without written consent by Hyundai C-Tech, Inc. dba HCT America, Inc. Hyundai C-Tech, Inc. dba HCT America, Inc., 1726 Ringwood Avenue, San Jose, CA 95131, USA TEL: +1-510-933-8848 FAX: +1-510-933-8849 REVISION HISTORY The revision history for this document is shown in table. TEST REPORT NO. DATE DESCRIPTION HA221024-MED-007-R02 July 21, 2023 Initial Issue HA221024-MED-007-R02-1 August 17, 2023 Page 7 of 8 : Corrected the contents of the Note Report No.: HA221024-MED-007-R02-1 3 / 8 This document may not be copied or reproduced (reprinted) without written consent by Hyundai C-Tech, Inc. dba HCT America, Inc. Hyundai C-Tech, Inc. dba HCT America, Inc., 1726 Ringwood Avenue, San Jose, CA 95131, USA TEL: +1-510-933-8848 FAX: +1-510-933-8849 TABLE OF CONTENTS 1. EUT DESCRIPTION ............................................................................................................................................ 4 2. INTRODUCTION ................................................................................................................................................ 5 2.1. RF Exposure Exemptions for Single Source .............................................................................................. 5 2.2. RF Exposure Exemptions for Simultaneous Transmission ......................................................................... 6 3. RESULT ............................................................................................................................................................ 7 3.1. 1-mW Blanket Exemption Calculation ..................................................................................................... 7 3.2. SUMMARY OF RESULTS .......................................................................................................................... 7 Report No.: HA221024-MED-007-R02-1 4 / 8 This document may not be copied or reproduced (reprinted) without written consent by Hyundai C-Tech, Inc. dba HCT America, Inc. Hyundai C-Tech, Inc. dba HCT America, Inc., 1726 Ringwood Avenue, San Jose, CA 95131, USA TEL: +1-510-933-8848 FAX: +1-510-933-8849 1. EUT DESCRIPTION Model P7850N EUT Type Ultra Low Power Active Medical Implant (ULP-AMI) Serial Number NTI501245H Power Supply 3 V d.c. RF Specification 175 kHz Transmitter Chain 1 Max. RF Output Power 76.6 dBuV/m @3m Exemption Analysis 1-mW Test Exemptions SAR-Based Test Exemptions MPE-Based Test Exemptions Antenna Specification 1) Loop Antenna Operating Environment Implantable device Operating Temperature -20 °C ~ 50 °C Note(s) : 1. Antenna information is based on the document provided. Report No.: HA221024-MED-007-R02-1 5 / 8 This document may not be copied or reproduced (reprinted) without written consent by Hyundai C-Tech, Inc. dba HCT America, Inc. Hyundai C-Tech, Inc. dba HCT America, Inc., 1726 Ringwood Avenue, San Jose, CA 95131, USA TEL: +1-510-933-8848 FAX: +1-510-933-8849 2. INTRODUCTION 2.1. RF Exposure Exemptions for Single Source (A) 1-mW Blanket Exemption Per § 1.1307(b)(3)(i)(A), a single RF source is exempt RF device if the available maximum time-averaged power is no more than 1 mW, regardless of separation distance. This exemption applies to all operating configurations and exposure conditions, for the frequency range 100 kHz - 100 GHz, regardless of fixed, mobile, or portable device exposure conditions. This is a standalone exemption, and it cannot be applied in conjunction with any other test exemption. (B) SAR-Based Exemption A more comprehensive exemption, considering a variable power threshold that depends on both the separation distance and power, is provided in § 1.1307(b)(3)(i)(B). This exemption is applicable to the frequency range between 300 MHz - 6 GHz, with test separation distances between 0.5 cm and 40 cm, and for all RF sources in fixed, mobile, and portable device exposure conditions. Accordingly, a RF source is considered an RF exempt device if its available maximum time-averaged (matched …

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

RF TEST REPORT F C C / I S E D APPLICANT Medtronic Inc. MODEL NAME P7850N FCC ID LF5P7850N ISED ID 3408D-P7850N REPORT NUMBER HA221024-MED-007-R01-1 Report No.: HA221024-MED-007-R01-1 1 / 22 This document may not be copied or reproduced (reprinted) without written consent by Hyundai C-Tech, Inc. dba HCT America, Inc. Hyundai C-Tech, Inc. dba HCT America, Inc., 1726 Ringwood Avenue, San Jose, CA 95131, USA TEL: +1-510-933-8848 FAX: +1-510-933-8849 T E S T R E P O R T Date of Issue August 17, 2023 Test Site Hyundai C-Tech, Inc. dba HCT America, Inc. 1726 Ringwood Ave, San Jose, CA 95131, USA Applicant Medtronic Inc. Applicant Address 710 Medtronic Parkway N.E., Minneapolis, MN 55432, U.S.A. FCC ID LF5P7850N ISED ID 3408D-P7850N Model Name P7850N EUT Type Ultra Low Power Active Medical Implant (ULP-AMI) Modulation Type 175 kHz (OOK burst) FCC Classification Low Power Transmitter Below 1705 kHz (DCD) FCC Rule Part(s) Part 15.209…

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