QRI-BM2610P2Implantable Cardiac Monitor

BIOTRONIK SE & Co. KG

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Application Details

Equipment Class: TNT - Licensed Non-Broadcast Transmitter Worn on Body
Date of Grant: May 07, 2023
Application Purpose: Original Equipment
Date of Application: May 02, 2023
Equipment Note: Implantable Cardiac Monitor
Frequency Range: 402.45000000 - 404.85000000
Company: BIOTRONIK SE & Co. KG
Country: Germany

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Document Text

Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.

Users Manual

BIOMONITOR IV Technical Manual © 2023 BIOTRONIK, Inc., All rights reserved. CAUTION Federal (U.S.A.) law restricts this device to sale by, or on the order of, a physician (or properly licensed practitioner). BIOMONITOR IV Injectable Cardiac Monitor BIOMONITOR IV X-Ray identification Radiopaque Identification A radiopaque identification code is visible on standard X-ray, and identifies the injectable cardiac monitor: BIOMONITOR IV Technical Manual BIOMONITOR IV BIOMONITOR IV Technical Manual Contents Chapter 1: Device Description 1 Chapter 2: Indications 3 Chapter 3: Contraindications 5 Chapter 4: Warnings and Precautions 7 4.1 MR SAFETY INFORMATION 7 4.1.1 Patient Pre-MR Conditions 7 4.1.2 MR Scanner Limitations 7 4.1.3 Restrictions during the MR Scan 8 4.2 Implanted Pacemakers and Defibrillators 8 4.3 Medical Therapy 8 4.4 Storage and Handling 9 4.5 Home Monitoring 10 4.6 Electromagnetic Interference (EMI) 10 4.6.1 Home and Occupational Environments 10 4.6.2 Cellular Phones 11 4.6.3 Hospital and Medical Environments 12 4.7 Insertable Cardiac Monitor Explant and Disposal 12 Chapter 5: Programmable Parameters 13 5.1 Parameters 13 5.1.1 ProgramConsult 14 5.1.2 Atrial Fibrillation (AF) 16 5.1.3 Tachycardia 21 5.1.4 Bradycardia 22 5.1.5 Sudden Rate Drop (SRD) 23 5.1.6 Pause Duration 24 5.1.7 Symptom 24 5.1.8 Resting Rate Period 25 BIOMONITOR IV Technical Manual 5.2 Home Monitoring (HM) 26 5.2.1 HM PID 26 5.2.2 Home Monitoring 26 5.2.3 Time of Transmission 26 5.2.4 Periodic Subcutaneous Electrocardiogram (sECG) 27 5.2.5 Daily Presenting Electrocardiogram (sECG) 27 5.2.6 Last Message 27 5.2.7 Episode Recording/Transmission 27 5.3 Patient Data 28 5.3.1 ID 28 5.3.2 First / Last Name 28 5.3.3 Date of Birth 29 5.3.4 Gender 29 5.3.5 Date of Implant 29 5.3.6 Hospital, City 29 5.3.7 Physician 29 5.3.8 NYHA 29 5.3.9 Symptom 30 5.3.10 Etiology 30 5.3.11 Remark 30 5.4 Sensing Settings 31 5.4.1 SensingConsult 32 5.4.2 Sensing High-Pass Filter 33 5.4.3 Input Signal Polarity 34 5.4.4 Input High-Pass Filter 34 Chapter 6: Diagnostics 35 6.1 Diagnostics Overview 35 6.2 General Statistical Information 35 6.3 Activity 35 6.3.1 Rate Trends 36 6.3.2 Rate Histogram 36 6.3.3 Activity Trend 37 6.4 AF Details 37 6.4.1 AF Trends 37 6.4.2 AF Time of Occurrence 38 6.4.3 AF Duration 38 6.4.4 Ventricular Rate During AF 39 6.4.5 Ectopy count 39 BIOMONITOR IV Technical Manual 6.5 Sensing 40 6.5.1 R-wave Trend 40 6.5.2 Noise Duration Trend 40 Chapter 7: Other Functions/Features 41 7.1 Home Monitoring 41 7.2 Transmission of Information 41 7.3 Patient Device 41 7.4 Transmitting Data 41 7.5 Types of Report Transmissions 42 7.6 Description of Transmitted Data 42 7.7 Patient Data Memory 43 7.8 Position Indicator 44 Chapter 8: Product Storage and Handling 45 8.1 Sterilization and Storage 45 Chapter 9: Follow-up Procedures 47 9.1 General Considerations 47 9.2 Real-time sECG Transmission 47 9.3 Follow-up Page 47 9.4 Recordings 48 9.5 sECG 49 9.5.1 Atrial Fibrillation 49 9.5.2 Tachycardia 50 9.5.3 Bradycardia 50 9.5.4 Pause 51 9.5.5 Symptom 51 Chapter 10: Elective Replacement Indication (ERI) 53 Chapter 11: Insertion/Removal 55 11.1 Opening the Sterile Container 55 11.2 Insertion 55 BIOMONITOR IV Technical Manual 11.3 Removal 58 11.4 Reasons to Remove an Injectable Cardiac Monitor 58 Chapter 12: Remote Assistant III 59 12.1 General Information on the Remote Assistant III 59 12.2 Remote Assistant III Functional Testing 59 12.3 Getting to Know the Remote Assistant III 59 12.4 Triggering a Manual Recording 60 12.5 Battery LED Indicator Explained 60 12.6 Signal Transmission LED Explained 61 Chapter 13: Technical Data 63 13.1 Parameters 63 13.1.1 Atrial Fibrillation 63 13.1.2 Tachycardia 63 13.1.3 Bradycardia 63 13.1.4 Sudden Rate Drop (SRD) 64 13.1.5 Pause Duration 64 13.1.6 Symptom 64 13.1.7 Resting Rate Period 64 13.1.8 Home Monitoring 65 13.2 Materials in Contact with Human Tissue 65 13.3 Electrical Data/Battery 65 13.4 Mechanical Data 65 Chapter 14: Order Information 67 BIOMONITOR IV Technical Manual This page left intentionally blank BIOMONITOR IV Technical Manual This page left intentionally blank Chapter 1 BIOMONITOR IV Technical Manual 1 Chapter 1: Device Description BIOMONITOR IV is a programmable, subcutaneous injectable cardiac monitor able to record subcutaneous ECGs (sECGs) and other physiological parameters. The BIOMONITOR IV is designed to automatically record the occurrence of arrhythmias in a patient. Arrhythmia may be classified as atrial fibrillation (AF), bradyarrhythmia, pause, sudden rate drop, or tachycardia. In addition, the BIOMONITOR IV can be activated by the patient to record cardiac rhythm during symptomatic episodes. Note - The BIOMONITOR IV subcutaneous ECG may differ from a surface ECG due to differences in electrode separation and device placement in the body. BIOMONITOR IV detects a subcutaneous ECG from a pair of electrodes. These signals are filtered in two different ways. For detection of QRS complexes, the signals are filtered with a passband of 10-40 Hz in order to suppress T-waves, artifacts, and baseline drift at low frequencies, and myopotentials and EMI at high frequencies. The resulting signal is appropriate for QRS detection as other components of the signal have been suppressed. This signal naturally does not have a typical ECG morphology due to the bandpass. For waveform display (real-time streaming sECG with the physician’s programmer and snapshots for review by the physician), a different passband is utilized to retain signal features that may have diagnostic value. This passband is 0.5 – 40 Hz, which is designed to retain morphological features of a typical ECG while still rejecting large low frequency artifacts and baseline drift. The BIOMONITOR IV system consists of three main components: 1. BIOMONITOR IV insertable cardiac monitor - The BIOMONITOR IV is a small, leadless device that is typically inserted under the skin, in the chest. The device uses two electrodes on the body of the de…

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Attestation Statements

The information provided in this letter is based on the referenced rule parts of Title 47 of the CFR as well as KDB 986446 D01. BIOTRONIK SE & Co. KG W oerm annkehre 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) Dr. Andreas Hecker 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, BIOTRONIK SE & Co. KG, hereby certify that the equipment for which authorization is sought (FCC ID: QRI-BM2610P2) is not “covered” equipment prohibited from receiving an equipment authorization pursuant to § 2.903 of the FCC rules. We also certify that, as of the date of the filing of the application, we are not identified on the Covered List (https://www.fcc.gov/supplychain/coveredlist) as an entity producing “covered” equipment. By signing this form, we confirm the above and that we are aware of the application requirements listed under § 2.911(b) and (d)(5) and (6). BIOTRONIK SE & Co. KG p.p. Dirk König Regulatory Affairs Senior Manager i.V. Axel Steiof Director Regulatory Affairs Tel +4 9 (0) 30 68905-1291 Fax +49 (0) 30 68905-961291 [email protected] www.biotronik.com Berlin, 21 March 2023 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

Attestation Statements

The information provided in this letter is based on the referenced rule parts of Title 47 of the CFR as well as KDB 986446 D01. An expiration date for this letter does not exist. In case the U.S. agent changes, the grantee is obligated to notify the FCC. 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) Dr. Andreas Hecker Stephan Schulz-Gohritz Kommanditgesellschaft: HRA 6501 B, AG Berlin-Charlottenburg Komplementärin: BIOTRONIK MT SE HRB 118866 B, AG Berlin-Charlottenburg U.S. Agent Designation BIOTRONIK SE & Co. KG acknowledges their consent for the following contact located in the United States to act as their agent for service of process for the equipment for which authorization is sought (FCC ID: QRI-BM2610P2): Name and company of U.S. agent: Jon Brumbaugh, BIOTRONIK Inc. Physical U.S. address of agent: 6024 Jean Road | Lake Oswego, OR 97035 | USA FRN of U.S. agent: 0033506395 Email address of U.S. agent: [email protected] Jon Brumbaugh, BIOTRONIC Inc., acknowledges his obligation to accept service of process on behalf of BIOTRONIK SE & Co. KG. BIOTRONIK SE & Co. KG with the FRN 0008008591 accepts its obligation to maintain an agent for service of process in the United States for no less than one year after either the grantee has permanently terminated all marketing and importation of the applicable equipment within the U.S., or the conclusion of any Commission-related administrative or judicial proceeding involving the equipment, whichever is later. By signing this form, we confirm the above and that we are aware of the application requirements listed under § 2.911(d)(7). Sincerely, Dirk König Regulatory Affairs Senior Manager BIOTRONIK SE & Co. KG Jon Brumbaugh VP, Regulatory Affairs and New Product Development BIOTRONIK, Inc. Tel +49 (0) 30 68905-1291 Fax +49 (0) 30 68905-961291 [email protected] www.biotronik.com Berlin, 25 April 2023 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

Cover Letter(s)

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) Dr. Andreas Hecker Stephan Schulz-Gohritz Kommanditgesellschaft: HRA 6501 B, AG Berlin-Charlottenburg Komplementärin: BIOTRONIK MT SE HRB 118866 B, AG Berlin-Charlottenburg Request for Confidentiality Company name: BIOTRONIK SE & Co. KG FCC ID: QRI-BM2610P2 In accordance with CFR 47 §0.457(d) and CFR 47 §0.459 of the Commission’s Rules, BIOTRONIK SE & Co. KG hereby requests confidentiality of following exhibits: Exhibit Type: Type of Confidentiality Requested Detailed block diagrams* x Long-term confidentiality Schematic diagrams* x Long-term confidentiality Detailed operational descriptions* x Long-term confidentiality Parts lists/ tune up information* x Long-term confidentiality Internal photos*** x Long-term confidentiality External photos X Short-term confidentiality** Test setup photos X Short-term confidentiality** User’s manual X Short-term confidentiality** Short- term maximum confidentiality period: 180 days Tel +49 (0) 30 68905-1291 Fax +49 (0) 30 68905-961291 [email protected] www.biotronik.com Berlin, 28 March 2023 Federal Communications Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 BIOTRONIK SE & Co. KG · Postfach 470255 · 12311 Berlin page 2 * Exhibits not routinely made available to the public. ** Only if applicable: Short-Term Confidentiality can be requested for a maximum of 180 days from the date of the grant. When the device is marketed the grantee must inform the TCB to release the Short- Term Confidentiality information withheld on the FCC equipment authorization website. *** Only if applicable: Long-Term Confidentiality can be requested if the circuit board or internal components are not accessible to users. For example, it is acceptable if the circuit board is enclosed in epoxy. Long-term confidentiality: The documents indicated as long-term confidential 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 the information is not publicly available. 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. Internal photos are requested long-term confidential as internal circuits of the medical implantable device are hermetically sealed (welded) and not accessible to any user. Short-term confidentiality (if applicable): BIOTRONIK SE & Co. KG requests the exhibits selected above as short-term confidential to be withheld from public view for the period as indicated above. When the device is marketed, BIOTRONIK SE & Co. KG will inform the TCB to release the short-term confidentiality information withheld on the FCC equipment authorization website. Sincerely, BIOTRONIK SE & Co. KG Dirk König Regulatory Affairs Senior Manager

External Photos

Implantable Cardiac Monitor BIOTRONIK SE & Co. KG IC ID 4708A-BM2610P2 FCC ID QRI-BM2610P2 G0M-2210-1712

ID Label/Location Info

ô ô ô ô ô ô ôô sbiotronik sbiotronik sbiotronik sbiotronik sbiotronik BIOMONITOR IV sbiotronik BIOMONITOR IV BIOMONITOR IV BIOMONITOR IV sbiotronik BIOMONITOR IV BIOMONITOR IV BIOMONITOR IV sbiotronik BIOMONITOR IV 12345678901234567890 1234567890 1234567890 U U 1234567890 1234567890 1234567890 U 1234567890 U U U UU sbiotronik sbiotronik sbiotronik sbiotronik sbiotronik sbiotronik sbiotronik sbiotronik sbiotronik sbiotroniksbiotronik sbiotronik sbiotronik sbiotronik sbiotronik sbiotronik sbiotronik BIOTRONIK SE & Co. KGWoermannkehre 112359 Berlin - Germany Manufacturer: Manufacturer:BIOTRONIK SE & Co. KGWoermannkehre 112359 Berlin - GermanyTel +49 (0) 30 68905-0Fax +49 (0) 30 6852804sales1biotronik.com Distributor:BIOTRONIK, Inc.6024 Jean RoadLake Oswego, OR 97035-5369(800) 547-0394 (24-hour)(503) 635-9936 (Fax) Distributor: BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035-5369 (800) 547-0394 (24-hour) (503) 635-9936 (Fax) BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin - Germany Tel +49 (0) 30 68905-0 Fax +49 (0) 30 6852804 sales1biotronik.com BIOMONITOR IVBIOMONITOR IV 477314 471155 1234567890 ûô ò 2025-02-28 ñ U 113 °F 14 °F è K FCC ID: QRI-BM2610P2 ð ð ù ÷ ô ô 1234567890 ô BIOMONITOR IV 1234567890 ô BIOMONITOR IV BIOMONITOR IV 96 1234567890 ô BIOMONITOR IVBIOMONITOR IV ôô BIOMONITOR IV 96 96 1234567890 1234567890 96 BIOMONITOR IV ô 96 92 96 1234567890 1234567890 BIOMONITOR IV 96 92 96 96 92 96 96 92 96 96 96 92 92 92 9292 92 1234567890 BIOMONITOR IV 1234567890 ôô 96 U 92 BIOMONITOR IV 92 U 1234567890 9696 96 UUU U 92 92 92 92 92 92 U U û U U BIOMONITOR IV û Data Sheet û Parameter û û û ô 471155 1234567890 ź 2025-02-28 ò Values at Factory Release ù ÷ Ø Ø Ø BIOMONITOR IV źź ź ò û ûûû û û 471155 è è 471155 471155 F 471155 ç 96 96 96 96 2025-02-28 471155 ú 471155471155 471155 471155 471155 471155 1234567890 ô ù 92 ôû BIOMONITOR IV 92 92 ò 92 ôû BIOMONITOR IV ò (01)04035479177850(17)250228(21)1234567890 Patient App (01)04035479177850(17)250228(21)1234567890 477314 471155 00f95fd 1234567890 U 1234567890 U 2025-02-28 471155 2025-02-28 Æ E Æ D ż E C D C ż ż ż Atrial fibrillation detection High ventricular rate detection Bradycardia detection Sudden rate drop detection Asystole detection Patient trigger Home monitoring OFF OFF OFF OFF OFF OFF OFF

ID Label/Location Info

RF Exposure Info

Test Report

Test Report No.: G0M-2210-1712-TFC95IMR-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 1 of 59 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-2210-1712-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 DE 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 Cardiac Monitor Model(s) BIOMONITOR IV Additional Model(s) None Brand Name(s) BIOTRONIK Hardware Version(s) BOM-0578_01_474897 (2610-30), SCH-0295_0B, ASM-0929_0C Software Version(s) ROM: 7748ROMRev_1.03 / RAM: 7341RamRev_3.01 FCC ID QRI-BM2610P2 IC 4708A-BM2610P2 Test Result PASSED Test Report No.: G0M-2210-1712-TFC95IMR-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 3 of 59 VERSION HISTORY Version History Version Issue Date Remarks Revised By 01 2023-02-16 Initial Release Test Report No.: G0M-2210-1712-TFC95IMR-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 4 of 59 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-2210-1712-TFC95IMR-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 5 of 59 REPORT INDEX 1 Equipment (Test Item) Under Test................................................................................................... 6 1.1 Photos – Equipment External ........................................................................................................................ 7 1.2 Photos – Equipment Internal ......................................................................................................................... 8 1.3 Photos – Test Setup ...................................................................................................................................... 9 1.4 Photos – Auxiliary/Associated Equipment ................................................................................................... 11 1.5 Test mode duty cycle .................................................................................................................................. 14 1.6 Test Modes ................................................................................................................................................. 16 1.7 Test Frequencies ......................................................................................................................................... 17 1.8 Sample emission level calculation ............................................................................................................... 18 1.9 Simulated human body ................................................................................................................................ 19 2 Result Summary ............................................................................................................................... 20 3 Test Conditions and Results .......................................................................................................... 21 3.1 Test Conditions and Results - Occupied bandwidth .................................................................................... 21 3.2 Test Conditions and Results - Emission bandwidth..................................................................................... 26 3.3 Test Conditions and Results - Frequency stability....................................................................................... 31 3.4 Test Conditions and Results - Transmitter output power ............................................................................. 33 3.5 Test Conditions and Results - Band-edge and In-band Emissions ............................................................. 35 3.6 Test Conditions and Results - Transmitter unwanted emissions ................................................................. 37 3.7 Test Conditions and Results - Receiver spurious emissions ....................................................................... 39 ANNEX A Transmitter output power ................................................................................................................. 41 ANNEX B Band-edge and In-band Emissions .................................................................................................. 45 ANNEX C Transmitter spurious emissions ....................................................................................................... 49 ANNEX D Receiver spurious emissions ........................................................................................................... 57 Test Report No.: G0M-2210-1712-TFC95IMR-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 6 of 59 1 Equipment (Test Item) Under Test Description Implantable Cardiac Monitor Model BIOMONITOR IV Additional Model(s) None Brand Name(s) BIOTRONIK Serial Number(s) 95043357(radiated test sample) Proto type (conducted test sample) Test Sample Id(s) 42363 (radiated test sample) 42486 (conducted test sample) Hardware Version(s) BOM-0578_01_474897 (2610-30), SCH-0295_0B, ASM-0929_0C Software Version(s) ROM: 7748ROMRev_1.03 / RAM: 7341RamRev_3.01 PMN BIOMONITOR IV HVIN 471155 …

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Test Report

Test Report No.: G0M-2210-1712-TFC209LP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 1 of 25 RADIO REPORT FCC 47 CFR Part 15C ISED RSS-310 License exempt radio equipment Report Reference No G0M-2210-1712-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 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 DE Test Specification 47 CFR Part 15C RSS-310, Issue 5, 2020-01 RSS-Gen, Issue 5, Amendment 2, 2021-02 Non-Standard Test Method None Equipment under Test (EUT): Product Description Implantable Cardiac Monitor Model(s) BIOMONITOR IV Additional Model(s) None Brand Name(s) BIOTRONIK Hardware Version(s) BOM-0578_01_474897 (2610-30), SCH-0295_0B, ASM-0929_0C Software Version(s) ROM: 7748ROMRev_1.03 / RAM: 7341RamRev_3.01 FCC ID QRI-BM2610P2 IC 4708A-BM2610P2 Test Result PASSED Test Report No.: G0M-2210-1712-TFC209LP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 3 of 25 VERSION HISTORY Version History Version Issue Date Remarks Revised By 01 2023-02-16 Initial Release Test Report No.: G0M-2210-1712-TFC209LP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 4 of 25 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-2210-1712-TFC209LP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 5 of 25 REPORT INDEX 1 Equipment (Test Item) Under Test................................................................................................... 6 1.1 Photos – Equipment External ........................................................................................................................ 7 1.2 Photos – Equipment Internal ......................................................................................................................... 8 1.3 Photos – Test Setup ...................................................................................................................................... 9 1.4 Photos – Auxiliary/Associated Equipment ................................................................................................... 10 1.5 Support Equipment ...................................................................................................................................... 12 1.6 Test mode duty cycle .................................................................................................................................. 13 1.7 Test Modes ................................................................................................................................................. 15 1.8 Test Frequencies ......................................................................................................................................... 16 1.9 Sample emission level calculation ............................................................................................................... 17 2 Result Summary ............................................................................................................................... 18 3 Test Conditions and Results ....................................................................…

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