QRI-IPG2267P2Implantable Pulse Generator

Amvia Stellar Pacemaker | Bradyarrhythmia Therapy | Cardiac Resynchronization Therapy Technical Manual 462977 Revision: A (2022-04-27) 0123 © BIOTRONIK SE & Co. KG All rights reserved. Specifications subject to modification, revision and improvement. ® All product names in use may be trademarks or registered trademarks held by BIOTRONIK or the respective owner. BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin / Germany Tel+49 (0) 30 68905-0 Fax+49 (0) 30 6852804 [email protected] www.biotronik.com Table of Contents 1 Table of Contents 1About this Technical Manual......................................................................................2 Objective............................................................................................................................................2 Technical manuals............................................................................................................................3 Conventions.......................................................................................................................................4 2Product Description....................................................................................................5 Intended Medical Purpose................................................................................................................5 System Overview...............................................................................................................................8 Diagnostic and Therapy Functions...................................................................................................13 3General Safety Instructions........................................................................................16 General Information on Safe Handling of the Device......................................................................16 Operating Conditions........................................................................................................................17 Possible Complications....................................................................................................................18 Possible Risks...................................................................................................................................20 4Implantation...............................................................................................................22 Implantation Procedure....................................................................................................................22 Precautionary Measures while Programming................................................................................26 Magnet Response.............................................................................................................................29 Follow-up..........................................................................................................................................30 Patient Information...........................................................................................................................31 Replacement Indications..................................................................................................................32 Explantation and Device Replacement............................................................................................34 5Parameter..................................................................................................................35 Bradycardia/CRT...............................................................................................................................35 Tachycardia.......................................................................................................................................41 Sensing..............................................................................................................................................42 Home Monitoring..............................................................................................................................43 Diagnostics........................................................................................................................................44 MRI program.....................................................................................................................................45 6Technical Data............................................................................................................46 Mechanical Characteristics..............................................................................................................46 Electrical Characteristics.................................................................................................................47 Battery Data......................................................................................................................................48 International radio certification........................................................................................................49 Legend for the Label.........................................................................................................................51 About this Technical Manual Objective 2 1About this Technical Manual Objective In this technical manual, you will find information for physicians and medical professionals regarding the device, the implantation, programming, and follow-up of an implantable pacemaker as well as information on safe handling of the device. About this Technical Manual Technical manuals 3 Technical manuals Technical manuals are either included in hard copy form in the storage package or available in digital form on the internet: https://manuals.biotronik.com. 1.Consult all relevant technical manuals. 2.Keep the technical manuals for future reference. To ensure safe operation, in addition to this technical manual, please also consult the followi…

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

BIOTRONIK SE & Co. KG W oermannkehre 1 12359 Berlin Steuer-Nr.: 30/005/75408 USt.-Ident Nr.: DE136651322 Tel +49 (0) 30 68905-0 Fax +49 (0) 30 6844060 [email protected] www.biotronik.com Geschäftsführende Direktoren: Dr. Daniel Bühler Dr. Thomas Kraft Stephan Schulz-Gohritz Kommanditgesellschaft: HRA 6501 B, AG Berlin-Charlottenburg Komplementärin: BIOTRONIK MT SE HRB 118866 B, AG Berlin-Charlottenburg ... ... ... To whom it may concern: We, the undersigned, hereby authorize Eurofins Product Service GmbH to act on our behalf in all matters relating to applications for equipment authorization FCC ID: QRI-IPG2267P2 including the signing of all documents related to these matters. Any and all acts carried out by Eurofins Product Service GmbH on our behalf shall have the same effect as acts of our own. We also hereby certify that no party to this application is subject to a denial of benefits, including FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862. Sincerely, Dirk König Regulatory Affairs Senior Manager BIOTRONIK SE & Co. KG Tel +49 (0) 30 68905-1291 Fax +49 (0) 30 68905-961291 [email protected] www.biotronik.com Berlin, May 5, 2022 Fede ral Communications Commission Authorization and Evaluation Division Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 BIOTRONIK SE & Co. KG · Postfach 470255 · 12311 Berlin

BIOTRONIK SE & Co. KG W oermannkehre 1 12359 Berlin Steuer-Nr.: 30/005/75408 USt.-Ident Nr.: DE136651322 Tel +49 (0) 30 68905-0 Fax +49 (0) 30 6844060 [email protected] www.biotronik.com Geschäftsführende Direktoren: Dr. Daniel Bühler Dr. Thomas Kraft Stephan Schulz-Gohritz Kommanditgesellschaft: HRA 6501 B, AG Berlin-Charlottenburg Komplementärin: BIOTRONIK MT SE HRB 118866 B, AG Berlin-Charlottenburg ... ... ... Request for Permanent Confidentiality C ompany name: BIOTRONIK SE & Co. KG FCC ID: QRI-IPG2267P2 FCC Part 15 Certification Dear Sir or Madam, I n accordance with CFR 47 § 0.457 and CFR 47 § 0.459 BIOTRONIK SE & Co. KG hereby requests confidentiality of following attachments: (1) schematic diagrams, (2) detailed block diagrams, (3) detailed operational descriptions, (4) parts lists. These documents contain detailed system and equipment description and related information about the product which BIOTRONIK SE & Co. KG considers to be proprietary, confidential and a custom design and otherwise would not release to the general public. Since the design is a basis from which future technological products will evolve, BIOTRONIK SE & Co. KG considers that this information would be of benefit to its competitors and that the disclosure of the information in these documents would give competitors an unfair advantage in the market. Si ncerely, Dirk König Regulatory Affairs Senior Manager BIOTRONIK SE & Co. KG Tel +49 (0) 30 68905-1291 Fax +49 (0) 30 68905-961291 [email protected] www.biotronik.com Berlin, 5 May 2022 Fede ral Communications Commission Authorization and Evaluation Division Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 BIOTRONIK SE & Co. KG · Postfach 470255 · 12311 Berlin

BIOTRONIK SE & Co. KG W oermannkehre 1 12359 Berlin Steuer-Nr.: 30/005/75408 USt.-Ident Nr.: DE136651322 Tel +49 (0) 30 68905-0 Fax +49 (0) 30 6844060 [email protected] www.biotronik.com Geschäftsführende Direktoren: Dr. Daniel Bühler Dr. Thomas Kraft Stephan Schulz-Gohritz Kommanditgesellschaft: HRA 6501 B, AG Berlin-Charlottenburg Komplementärin: BIOTRONIK MT SE HRB 118866 B, AG Berlin-Charlottenburg ... ... ... Request for Short Term Confidentiality, intended to allow importation / distribution of authorized equipment while maintaining confidentiality before product launch C ompany name: BIOTRONIK SE & Co. KG FCC ID: QRI-IPG2267P2 FCC Part 15 Certification Dear Sir or Madam, In accordance with 0.457 and 0.459 of CFR 47, B IOTRONIK SE & Co. KG hereby requests for ‘Short Term Confidentiality of all • External Photos, • Test Setup Photos, • Internal Photos, • User manual / Instruction For Use attachments for the subject application. These documents contain detailed system and equipment description and related information about the product which BIOTRONIK SE & Co. KG considers to be proprietary, confidential and a custom design and otherwise would not release to the general public. Since the design is a basis from which future technological products will evolve, BIOTRONIK SE & Co. KG considers that this information would be of benefit t o its competitors and that the disclosure of the information in these documents would give competitors an unfair advantage in the market. Si ncerely, Dirk König Regulatory Affairs Senior Manager BIOTRONIK SE & Co. KG Tel +49 (0) 30 68905-1291 Fax +49 (0) 30 68905-961291 [email protected] www.biotronik.com Berlin, 5 May 2022 Fede ral Communications Commission Authorization and Evaluation Division Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 BIOTRONIK SE & Co. KG · Postfach 470255 · 12311 Berlin

BIOTRONIK SE & Co. KG W oermannkehre 1 12359 Berlin Steuer-Nr.: 30/005/75408 USt.-Ident Nr.: DE136651322 Tel +49 (0) 30 68905-0 Fax +49 (0) 30 6844060 [email protected] www.biotronik.com Geschäftsführende Direktoren: Dr. Daniel Bühler Dr. Thomas Kraft Stephan Schulz-Gohritz Kommanditgesellschaft: HRA 6501 B, AG Berlin-Charlottenburg Komplementärin: BIOTRONIK MT SE HRB 118866 B, AG Berlin-Charlottenburg ... ... ... Declaration concerning Antenna Specification It is hereby declared that the product Model No .: Amvia Stellar DR-T, additional model acc. Family List FCC ID: QRI-IPG2267P2 fulfills the requirement in FCC test relating to the antenna type. The device specified above confirms to the FCC recommendations for internal antenna type d escribed below: Model No. of antenna: PNP Mini-Rings Antenna Type of antenna: interconnected ring, monopole antenna, permanently attached (welded) and contained within the device's epoxy header Gain of the antenna: -28.68 dBi Frequen cy range: 401-406 MHz The mounting of the antenna is fixed to the radio module and no other antenna should be used. Sincerely Dirk König Regulatory Affairs Senior Manager BIOTRONIK SE & Co. KG Tel +49 (0) 30 68905-1291 Fax +49 (0) 30 68905-961291 [email protected] www.biotronik.com Berlin, 5 May 2022 Fede ral Communications Commission Authorization and Evaluation Division Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 BIOTRONIK SE & Co. KG · Postfach 470255 · 12311 Berlin

Test Report No.: G0M-2111-1166-TFC209LP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 5 of 29 Test Report No.: G0M-2111-1166-TFC209LP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 9 of 29 1.1 Photos – Equipment External EUT overview EUT Top View Test Report No.: G0M-2111-1166-TFC209LP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 10 of 29 EUT Bottom View EUT Conducted Test Report No.: G0M-2111-1166-TFC209LP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 11 of 29 Not Tested Modul - Amvia Sky HF-T QP Top View Not Tested Modul - Amvia Sky HF-T QP Bottom View Test Report No.: G0M-2111-1166-TFC209LP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 12 of 29 Not Tested Modul - Amvia Sky HF-T Top View Not Tested Modul - Amvia Sky HF-T Bottom View Test Report No.: G0M-2111-1166-TFC209LP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 13 of 29 Not Tested Modul - Amvia Sky DR-T Top View Not Tested Modul - Amvia Sky DR-T Bottom View Test Report No.: G0M-2111-1166-TFC209LP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 14 of 29 Not Tested Modul - Amvia Sky SR-T Top View Not Tested Modul - Amvia Sky SR-T Bottom View

ý (01)04035479174040(17)240228(21)1234567890 BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin - Germany BIOTRONIK SE & Co. KGWoermannkehre 112359 Berlin - GermanyTel +49 (0) 30 68905-0Fax +49 (0) 30 6852804sales+biotronik.com BIOTRONIK, Inc.6024 Jean RoadLake Oswego, OR 97035-5369(800) 547-0394 (24-hour)(503) 635-9936 (Fax) 45 °C -10 °C ñ U 2022-02 å 2024-02 ò Amvia Sky HF-T QP Amvia Sky HF-T QP ź (01)04035479174040(17)240228(21)1234567890 1234567890 ô 460158 M N N N N N N e M M M û ý{ 0AE-DDDRV RA IS-1 UNI/BI RA IS-1 UNI/BI RA IS-1 UNI/BI LV IS4 LLLL RV IS-1 UNI/BI LV IS4 LLLLRV IS-1 UNI/BI LV IS4 LLLLRV IS-1 UNI/BI ý 0AE-DDDRV 472972 K K FCC ID:QRI-IPG2267P2 FCC ID:QRI-IPG2267P2 ý ð ð ù ù Æ ö ÷ manuals.biotronik.com manuals.biotronik.com è ô 1234567890 ôôô 123456789012345678901234567890 Amvia Sky HF-T QPAmvia Sky HF-T QPAmvia Sky HF-T QP 969696 929292 UUU U U 96 96 ô ô 92 92 1234567890 1234567890 Amvia Sky HF-T QP Amvia Sky HF-T QP Amvia Sky HF-T QP û ô ô û 460158 1234567890 96 96 96 96 96 96 9696 96 96 96 96 U U U U û û û ô ô ô ô Ø Ø û è ź ç ú ] ô ôô ô ô ô ô ô UUUU U U U U 1234567890 12345678901234567890 1234567890 1234567890 1234567890 1234567890 1234567890 92 92 92 92 460158 1234567890 460158 460158 460158 1234567890 1234567890 1234567890 Amvia Sky HF-T QP Amvia Sky HF-T QP Amvia Sky HF-T QP 92 U 92 U 92 U 96 92 9292 92 92 96 96 92 92 92 ý{ 0AE-DDDRV 472972 2024-02 2022-02 å ò ô û UDI-DI: 04035479174040 4601581234567890 460158 1234567890 7ce8ad5 æ W æ Amvia Sky HF-T QP sbiotronik sbiotroniksbiotroniksbiotroniksbiotronik sbiotroniksbiotronik sbiotroniksbiotroniksbiotronik sbiotronik sbiotronik sbiotronik sbiotronik sbiotronik sbiotronik sbiotronik sbiotronik sbiotronik sbiotroniksbiotronik sbiotronik sbiotronik 0 ms Dynamic Amvia Sky HF-T QP Auto Amvia Sky HF-T QP 0.4 ms Amvia Sky HF-T QP 3.0 V Amvia Sky HF-T QP Amvia Sky HF-T QP Amvia Sky HF-T QP Amvia Sky HF-T QP Amvia Sky HF-T QP Amvia Sky HF-T QP Amvia Sky HF-T QP DDD=50min-1

BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin Steuer-Nr.: 30/005/75408 USt.-Ident Nr.: DE136651322 Tel +49 (0) 30 68905-0 Fax +49 (0) 30 6844060 [email protected] www.biotronik.com Geschäftsführende Direktoren: Dr. Alexander Uhl (Vorsitzender) Stephan Schulz-Gohritz Kommanditgesellschaft: HRA 6501 B, AG Berlin-Charlottenburg Komplementärin: BIOTRONIK MT SE HRB 118866 B, AG Berlin-Charlottenburg Label Location Statement Company name: BIOTRONIK SE & Co. KG FCC ID: QRI-IPG2267P2 FCC Part 15 Certification To whom it may concern: Compliance statement: The text as defined in 15.19(a)(3) and RSS-Gen §8.4 (IC) is too large to be placed on the label of the Device and the device itself is smaller than defined in KDB 784748. Therefore, it will be placed in a prominent location of the user guide. Certification IDs: According to 2.925 (f) and RSS-Gen §4.1 (IC) it is impractical to print the certification IDs on a device to be implanted into the human body. Therefore, the certification IDs are printed at the user guide as well as on the packaging label of the devices. Sincerely Dirk König Manager Regulatory Affairs BIOTRONIK SE & Co. KG Tel +49 (0) 30 68905-1291 Fax +49 (0) 30 68905-1921 [email protected] www.biotronik.com Berlin, 15 December 2022 Federal Communications Commission Authorization and Evaluation Division Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 BIOTRONIK SE & Co. KG · Postfach 470255 · 12311 Berlin

Test Report No.: G0M-2111-1166-TFC209LP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 4 of 29 Test Report No.: G0M-2111-1166-TFC209LP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 15 of 29 1.2 Photos – Equipment Internal PC-Board 2260 Top View PC-Board 2260 Bottom View Test Report No.: G0M-2111-1166-TFC209LP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 16 of 29 PC-Board 2270 Top View PC-Board 2270 Bottom View

BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin Steuer-Nr.: 30/005/75408 USt.-Ident Nr.: DE136651322 Tel +49 (0) 30 68905-0 Fax +49 (0) 30 6844060 [email protected] www.biotronik.com Geschäftsführende Direktoren: Dr. Alexander Uhl (Vorsitzender) Stephan Schulz-Gohritz Kommanditgesellschaft: HRA 6501 B, AG Berlin-Charlottenburg Komplementärin: BIOTRONIK MT SE HRB 118866 B, AG Berlin-Charlottenburg IPG2267P2 SAR-Statement To whom it may concern, In FCC KDB 447498 General RF Exposure Guidance D01 v06, Section 4.2.4, the FCC provides a power threshold, below which implanted devices excluded from SAR measurement or numerical simulation: “When the aggregate of the maximum power available at the antenna port and radiating structures of an implanted transmitter, under all operating circumstances, is ≤ 1.0 mW, SAR test exclusion may be applied. The maximum available output power requirement and worst-case operating conditions must be supported by power measurement results, based on device design and implementation requirements, and fully justified in a SAR analysis report according to KDB Publication 865664 D02, in lieu of SAR measurement or numerical simulation.” Since both the radiated output power and conducted output power are well below 1.0 mW, this device is excluded from SAR measurement or numerical simulation. FCC ID: QRI-IPG2267P2 is compliant with FCC RF Exposure requirements. Thank you for your kind attention. Sincerely yours, BIOTRONIK SE & Co. KG p.p. Dirk König Regulatory Affairs Senior Manager BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin, Germany Tel +49 (0) 30 68905-1291 Fax +49 (0) 30 68905-1921 [email protected] www.biotronik.com Berlin, December 29, 2022 BIOTRONIK SE & Co. KG · Postfach 470255 · 12311 Berlin

Test Report No.: G0M-2111-1166-TFC95IMR-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 1 of 88 RADIO REPORT FCC 47 CFR Part 95I Medical Device Radiocommunication Service (MedRadio) ISED RSS-243 Medical Devices Operating in the 401 – 406 MHz Frequency Band Report Reference No G0M-2111-1166-TFC95IMR-V01 Testing Laboratory Eurofins Product Service GmbH Address Storkower Str. 38c 15526 Reichenwalde Germany Accreditation DAkkS - Registration number : D-PL-12092-01-03 (ISED) ISED Testing Laboratory site: 3470A DAkkS - Registration number : D-PL-12092-01-04 (FCC) FCC Filed Test Laboratory, Reg.-No.: 96970 Applicant BIOTRONIK SE & Co. KG Address Woermannkehre 1 12359 Berlin GERMANY Test Specification 47 CFR Part 95I ISED RSS-243, Issue 3, 2010-02 ISED RSS-Gen, Issue 5, Amendment 2, 2021-02 Non-Standard Test Method None Equipment under Test (EUT): Product Description Implantable Pulse Generator Model(s) Amvia Stellar DR-T Additional Model(s) additional model see family list Brand Name(s) BIOTRONIK Hardware Version(s) 0A Software Version(s) ROM: 1.0 / RAM: 1.0 FCC ID QRI-IPG2267P2 IC 4708A-IPG2267P2 Test Result PASSED Test Report No.: G0M-2111-1166-TFC95IMR-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 3 of 88 ADDITIONAL VARIANTS (not tested and not evaluated variants) Test Report No.: G0M-2111-1166-TFC95IMR-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 6 of 88 Version History Version Issue Date Remarks Revised By 01 2022-03-01 Initial Release Test Report No.: G0M-2111-1166-TFC95IMR-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 7 of 88 ABBREVIATIONS AND ACRONYMS Acronyms Acronym Description EUT Equipment Under Test FCC Federal Communications Commission ISED Innovation, Science and Economic Development Canada RBW Resolution bandwidth RMS Root mean square VBW Video bandwidth V NOM Nominal supply voltage Test Report No.: G0M-2111-1166-TFC95IMR-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 8 of 88 REPORT INDEX 1 Equipment (Test Item) Under Test................................................................................................... 9 1.1 Photos – Equipment External ...................................................................................................................... 10 1.2 Photos – Equipment Internal ....................................................................................................................... 16 1.3 Photos – Test Setup .................................................................................................................................... 18 1.4 Photos – Auxiliary/Associated Equipment ................................................................................................... 20 1.5 Support Equipment ...................................................................................................................................... 21 1.6 Test mode duty cycle .................................................................................................................................. 22 1.7 Test Modes ................................................................................................................................................. 24 1.8 Test Frequencies ......................................................................................................................................... 25 1.9 Sample emission level calculation ............................................................................................................... 26 1.10 Simulated human body ................................................................................................................................ 27 2 Result Summary ............................................................................................................................... 28 3 Test Conditions and Results .......................................................................................................... 29 3.1 Test Conditions and Results - Occupied bandwidth .................................................................................... 29 3.2 Test Conditions and Results - Emission bandwidth..................................................................................... 43 3.3 Test Conditions and Results - Frequency stability....................................................................................... 57 3.4 Test Conditions and Results - Transmitter output power ............................................................................. 59 3.5 Test Conditions and Results - Band-edge and In-band Emissions ............................................................. 61 3.6 Test Conditions and Results - Transmitter unwanted emissions ................................................................. 63 3.7 Test Conditions and Results - Receiver spurious emissions ....................................................................... 65 ANNEX A Transmitter output power ................................................................................................................. 67 ANNEX B Band-edge and In-band Emissions .................................................................................................. 71 ANNEX C Transmitter spurious emissions ....................................................................................................... 75 ANNEX D Receiver spurious emissions ........................................................................................................... 83 Test Report No.: G0M-2111-1166-TFC95IMR-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 9 of 88 1 Equipment (Test Item) Under Test Description Implantable Pulse Generator Model Amvia Stellar DR-T Additional Model(s) additional model see family list Brand Name(s) BIO…

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

Test Report No.: G0M-2111-1166-TFC209LP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 1 of 29 FCC TEST REPORT FCC 47 CFR Part 15C ISED RSS-310 License exempt radio equipment Report Reference No. .................... : G0M-2111-1166-TFC209LP-V01 Testing Laboratory ........................ : Eurofins Product Service GmbH Address ............................................ : Storkower Str. 38c 15526 Reichenwalde Germany Accreditation .................................... : DAkkS - Registration number : D-PL-12092-01-03 (ISED) ISED Testing Laboratory site: 3470A-2 DAkkS - Registration number : D-PL-12092-01-04 (FCC) FCC Filed Test Laboratory, Reg.-No.: 96970 Applicant’s name ........................... : BIOTRONIK SE & Co. KG Address ............................................ : Woermannkehre 1 12359 Berlin GERMANY Test specification: Standard ........................................... : 47 CFR Part 15C RSS-310, Issue 4, 2015-07 Test scope.............. ....................... : complete Radio compliance test Equipment under test (EUT): Product description Implantable Pulse Generator Model No. Amvia Stellar DR-T Additional Model(s) additional model see family list Brand Name(s) BIOTRONIK Hardware version 0A Firmware / Software version ROM: 1.0 / RAM: 1.0 FCC-ID: QRI-IPG2267P2 IC: 4708A-IPG2267P2 Test result Passed Test Report No.: G0M-2111-1166-TFC209LP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 3 of 29 ADDITIONAL VARIANTS (not tested and not evaluated variants) Test Report No.: G0M-2111-1166-TFC209LP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 6 of 29 Version History Version Issue Date Remarks Revised by 01 2022-03-01 Initial Release Test Report No.: G0M-2111-1166-TFC209LP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 7 of 29 REPORT INDEX 1 EQUIPMENT (TEST ITEM) DESCRIPTION 8 1.1 Photos – Equipment External 9 1.2 Photos – Equipment Internal 15 1.3 Photos – Test Setup 17 1.4 Photos – Auxiliary/Associated Equipment 18 1.2 Supporting Equipment Used During Testing 19 1.3 Test Modes 20 1.4 Test Equipment Used During Testing 21 1.5 Sample emission level calculation 22 2 RESULT SUMMARY 23 3 TEST CONDITIONS AND RESULTS 24 3.1 Test Conditions and Results – Occupied Bandwidth 24 3.2 Test Conditions and Results – Fundamental field strength emissions 26 3.3 Test Conditions and Results – Receiver radiated emissions 28 Test Report No.: G0M-2111-1166-TFC209LP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 8 of 29 1 Equipment (Test item) Description Description Implantable Pulse Generator Model Amvia Stellar DR-T Additional Model(s) additional model see family list Brand Name(s) BIOTRONIK Serial number 1000000408 Radiated Test Sample ID 38057 0423321243 Conducted Test Sample ID 38093 Hardware version 0A Software / Firmware version ROM: 1.0 / RAM: 1.0 PMN Amvia Stellar DR-T HVIN 460167 FVIN N/A HMN N/A FCC-ID QRI-IPG2267P2 IC 4708A-IPG2267P2 Equipment type End product Radio type Transceiver Radio technology custom Operating frequency 64 kHz Modulations OOK Number of channels 1 Channel spacing None Number of antennas 1 Antenna Type integrated Model Coil antenna Manufacturer Biotronik SE & Co. KG Gain unspecified Manufacturer BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin GERMANY Power supply V NOM 3.0 VDC (lithium battery) V MIN 2.5 VDC V MIN 3.2 VDC Operating Temperature T NOM 37 °C T MIN 25 °C T MAX 45 °C AC/DC-Adaptor Model None Test Report No.: G0M-2111-1166-TFC209LP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 19 of 29 1.2 Supporting Equipment Used During Testing Product Type* Device Manufacturer Model Comments AE1 Communication Adapter Biotronik TelBox II - AE2 Programming Head Biotronik PGH 3000 - *Note: Use the following abbreviations: AE : Auxiliary/Associated Equipment, or SIM : Simulator (Not Subjected to Test) CABL : Connecting cables Test Report No.: G0M-2111-1166-TFC209LP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 20 of 29 1.3 Test Modes Mode # Description Transmit General conditions: EUT powered by fully charged battery Rad…

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