QRIPRIMUSPRIMUS (aka EVIA or ENTOVIS) family of implantable pacemakers

BIOTRONIK mbH & o K Woermannkehre 1 12359 Berln  ermany Tel+49 (0) 30 68905–0 Fax+49 (0) 30 6852804 salesbotronkcom wwwbotronkcom ardac Rhythm Management Bradycarda therapy Techncal Manual Eva Pacemaker wth automatc Functons and BIOTRONIK Home Montorng ® © BIOTRONIK mbH & o K All rghts reserved Spec catons subect to mod caton, revson and mprovement 2009-D-xx ® BIOTRONIK Home Montorng and Entovs are regstered trademarks of BIOTRONIK mbH & o K Ths product conforms wth the drectves 90/385/EE relatng to actve mplantable medcal devces and 99/5/E on rado equpment and telecommuncaton termnal equp- ment It was approved by ndependent Not ed Bodes and s therfore desgnated wth the E mark The product can be used n all European Unon countres as well as n countres that recognze the above-mentoned drectves 9 365353--A_GA_Evia_A6_Cover_PB.in1-2 1-223.04.2009 15:45:24 sbiotronik Evia DR-T, DR, SR-T, SR Pacemaker Bradycardia therapy Technical manual for the implant Doc. Id.: 365353-A Index 365353-ATechnical manual for the implantEvia DR-T, DR, SR-T, SR 2 3Table of Contents Table of Contents Table of Contents Product Description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Intended Medical Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Implant Variants and NBG Codes . . . . . . . . . . . . . . . . . . . . . . 8 Diagnostic and Therapy Functions . . . . . . . . . . . . . . . . . . . . . 9 Scope of Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 General Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Possible Medical Complications. . . . . . . . . . . . . . . . . . . . . . 13 Possible Technical Complications . . . . . . . . . . . . . . . . . . . . 14 Possible Electromagnetic Complications . . . . . . . . . . . . . . 15 Possible Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Prior to Implantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Indications and Contraindications . . . . . . . . . . . . . . . . . . . . 17 Ambient Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Sterility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Preparing the Implantation. . . . . . . . . . . . . . . . . . . . . . . . . . 20 Implantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Implanting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Connecting PM Leads . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Precautionary Measures while Programming . . . . . . . . . . 24 After Implantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Follow-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Notes for the Physician . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Replacement Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Explantation and Implant Replacement. . . . . . . . . . . . . . . . 31 4Table of Contents Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Pacing Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Timing DR(-T) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Timing SR(-T) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Pacing and Sensing DR(-T) . . . . . . . . . . . . . . . . . . . . . . . . . 38 Pacing and Sensing SR(-T) . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Rate Adaptation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Preset Programs DR(-T) . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Preset Programs SR(-T) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 Tolerances of Parameter Values . . . . . . . . . . . . . . . . . . . . . 45 Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 Mechanical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . 47 Electrical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 Battery Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 Country-Related Information . . . . . . . . . . . . . . . . . . . . . . . . 51 Legend for the Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 5 1Product Description Product Description1365353-ATechnical manual for the implantEvia DR-T, DR, SR-T, SR Intended Medical Use Intended useEvia is a family of implantable pacemakers that may be implanted for all bradycar- dia arrhythmia indications. The primary objective of the therapy consists of improv- ing patients' symptoms that can be clinically manifested. The implantation of the pacemaker is a symptomatic therapy with the following objective: • Compensation of bradycardia by atrial, ventricular, or AV sequential pacing Diagnosis and therapy forms The cardiac rhythm is automatically monitored and bradycardia arrhythmias are treated. All major therapeutic approaches from the field of cardiology and electro- physiology are unified in the Evia family. BIOTRONIK Home Monitoring ® enables physicians to perform therapy manage- ment any time. Required expertiseIn addition to having basic medical knowledge, the user must be thoroughly famil- iar with the operation of an implant system. Only qualified medical specialists hav- ing the special knowledge required for the proper use of implants are permitted to use them. If users do not possess this knowledge, they must be trained acc…

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Evia Family of Implantable Pulse Generators Technical Manual Evia Implantable Pulse Generators Evia DR X-Ray identification Evia DR-T X-Ray identification Radiopaque Identification A radiopaque identification code is visible on standard x-ray, and identifies the pulse generator: Evia DR, DR-T, SR, and SR-T SF CAUTION Because of the numerous available 3.2-mm configurations (e.g., the IS-1 and VS-1 standards), lead/pulse generator compatibility should be confirmed with the pulse generator and/or lead manufacturer prior to the implantation of a pacing system. IS-1, wherever stated in this manual, refers to the international standard, whereby leads and generators from different manufacturers are assured a basic fit. [Reference ISO 5841-3:1992(E)]. CAUTION Federal (U.S.A.) law restricts this device to sale by or on the order of, a physician (or properly licensed practitioner). ©2009 BIOTRONIK, Inc., all rights reserved. Evia Technical Manual i Contents 1. Device Description .......................................................... 1 2. Indications ........................................................................ 4 3. Contraindications ............................................................ 6 4. Warnings and Precautions ............................................. 8 4.1 Medical Therapy .......................................................... 8 4.2 Storage and Sterilization ........................................... 10 4.3 Lead Connection and Evaluation .............................. 10 4.4 Programming and Operation ..................................... 12 4.5 Home Monitoring ....................................................... 14 4.6 Electromagnetic Interference (EMI) .......................... 15 4.6.1 Home and Occupational Environments ............... 16 4.6.2 Cellular Phones .................................................... 17 4.6.3 Hospital and Medical Environments .................... 18 4.7 Pulse Generator Explant and Disposal ..................... 19 5. Adverse Events .............................................................. 21 5.1 Observed Adverse Events ......................................... 21 5.1.1 Dromos DR Clinical Study ................................... 21 5.1.2 PACC Clinical Study ............................................ 23 5.1.3 Inos2+ CLS Clinical Study ................................... 24 5.2 Potential Adverse Events .......................................... 26 6. Clinical Study ................................................................. 27 6.1 Dromos DR ................................................................ 27 6.2 Ventricular Capture Control ....................................... 28 6.2.1 Primary Objectives ............................................... 29 6.2.2 Methods ............................................................... 29 6.2.3 Results ................................................................. 29 6.2.4 Clinical Study Conclusions ................................... 34 6.3 Closed Loop Stimulation (CLS) ................................. 35 6.3.1 Protos DR/CLS Response to Mental Stress ........ 35 6.3.2 Protos DR CLS with AxVx .................................... 38 6.3.3 Inos 2+ CLS ............................................................ 41 6.4 TRUST Clinical Study ................................................ 44 6.4.1 Study Overview .................................................... 44 6.4.2 Methods ............................................................... 45 6.4.3 Summary of Clinical Results ................................ 47 ii Evia Technical Manual 6.4.4 Conclusions .......................................................... 51 7. Programmable Parameters ........................................... 53 7.1 Pacing Modes ............................................................ 53 7.1.1 Motion Based Rate-Adaptive Modes ................... 53 7.1.2 CLS Modes .......................................................... 53 7.1.3 Non-Rate-Adaptive Modes ................................... 54 7.1.4 Mode Switching .................................................... 55 7.1.5 Pacing Modes with Triggered Response ............. 56 7.2 Rate Related Functions ............................................. 57 7.2.1 Basic Rate ............................................................ 57 7.2.2 Rate Hysteresis .................................................... 58 7.2.3 Scan Hysteresis ................................................... 59 7.2.4 Repetitive Hysteresis ........................................... 60 7.2.5 Night Mode ........................................................... 61 7.2.6 Rate Fading .......................................................... 62 7.3 Pulse Specific Features ............................................. 63 7.3.1 Pulse Amplitude ................................................... 63 7.3.2 Pulse Width .......................................................... 64 7.4 Automatic Sensitivity Control (ASC) .......................... 64 7.5 Timing Features ........................................................ 65 7.5.1 Refractory Periods ............................................... 65 7.5.2 PVARP ................................................................. 65 7.5.3 AV Delay .............................................................. 67 7.5.4 Ventricular Blanking Period .................................. 71 7.5.5 Atrial Blanking Period ........................................... 72 7.5.6 Far-Field Protection ............................................. 72 7.5.7 Safety AV Delay ................................................... 72 7.5.8 Upper Rate and UTR Response .......................... 73 7.6 Lead Polarity ............................................................. 73 7.7 Parameters for Rate-Adaptive Pacing ...................... 74 7.7.1 Sensor Gain ......................................................... 75 7.7.2 Automatic Sensor Gain ......…

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2 / 3 02_Primus 731Form 95I.doc Item 8. Confidentiality Request: (a) Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules? Yes No (b) Does short-term confidentiality apply to this application? Yes No If yes, specify the short-term confidentiality release date: MM/DD/YYYY Item 9. Related OET KnowledgeDataBase (KDB) Inquiry: Is there a KDB inquiry associated with this application? Yes No If so, enter the inquiry tracking number: Item 10. Modular Approval: Is this application for modular approval? If “Yes”, please submit a cover letter addressing the modular approval requirements of DA 00-1407 . Yes No Modular Type: Please chose: Item 11. Software Defined Radio Authorization: Is this application for software defined radio authorization? Yes No Item 12. Equipment Class: TNT Description of product as it is marketed: (Note: This text will appear below the equipment class on the grant): PRIMUS (aka EVIA or ENTOVIS) family of implantable pacemakers Item 13. Application Purpose:: Original equipment Change in identification of presently authorized equipment: Original FCC ID: Grant date (MM/DD/YYY): Class II permissive change or modification of presently authorized equipment Item 14. Composite / Related Equipment: Is the equipment in this application: (a) a composite device subject to an additional equipment authorization? Yes No (b) part of a system that operates with, or is marketed with, another device that requires an equipment authorization? Yes No If either of the above questions is answered “Yes”, please complete section 13(c). (c) The related application: FCC ID(s): has been granted under the FCC ID(s) listed to the right is in the process of being filed under the FCC ID(s) listed to the right is pending with the FCC under the FCC ID(s) listed to the right has a mix of pending and granted statuses under the FCC ID8s) to the right: Item 15. Test Firm Information: Name of test firm and contact person on file with the FCC, if different from applicant or contact person: Company Name: Eurofins Product Service GmbH Contact Name: Jens Zimmermann Address: Storkower Str. 38c City: Reichenwalde State: Zip Code: 15526 Country: Germany Phone: +49 33631 888-200 Fax: +49 33631 888-640 E-Mail: jenszimmermann@eurofin s.de FCC Registered Test Site Number (required for part 15 and 18 applications): 96970 Item 16. Grant Comments: Note: Text will appear at the bottom of the Grant of Equipment Authorization.

2 March 2010 Mr. Tim Harrington Federal Communications Commission Authorization and Evaluation Division Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 FCCID: QRIPRIMUS Biotronik is submitting this document in response to correspondence 38625 from the FCC. Item 1: 1) Please note that for correspondence replies, besides any exhibits themselves we generally request also an item-by-item explanation for how each issue is resolved, i.e. either by details given in such item-by-item explanation, and/or explanation how each associated exhibit addresses each item. This reply can be in form of separate self-contained corresp. in the e-filing system, and/or a cover letter exhibit listing each question and answer. For the preceding corresp. in this filing, 38513/38514 and 38618/38619, such item-by-item replies are not required at this stage - however we have repeated in the following some of the preceding info requests where it was unclear whether and how those were addressed. Answer to Item 1: An item-by-item explanation for the further information requests in this correspondence follows in question and answer format. Where another exhibit is needed, an explanation is given as to how that exhibit resolves the issue. Item 2: 2) further to corresp. 38513/38514 item 5), if not in filing already please explain differences between the following models, and include photos and/or sketches if differences involve size, shape, properties etc of materials proximate to antenna: Evia SR, Evia SR coated, Evia SR-T, Evia SR-T coated, Evia DR, Evia DR coated, Evia DR-T, Evia DR-T coated, Entovis SR, Entovis SR coated, Entovis SR-T, Entovis SR-T coated, Entovis DR, Entovis DR coated, Entovis DR-T, Entovis DR-T coated. Answer to Item 2: Differences between models within the PRIMUS family are: • The Evia models have a different (software-defined) medical therapy feature set than the Entovis models. These feature differences have no impact on RF, and do not involve differences in size, shape or properties of materials proximate to antenna. • The –T models are capable of RF transmissions; the other models are not capable of RF transmissions. This does not involve differences in size, shape or properties of materials proximate to antenna. • The coated models have a thin medical grade silicone rubber coating over most of the housing; this is not on the header or proximate to the antenna. This does not involve differences in size, shape or properties of materials proximate to antenna. • The SR models both provide cardiac therapy; the DR models impact two chambers of the human heart; the SR models impact one chamber of the human heart. • The SR-T models use a slightly smaller (and lower gain) antenna. The antennas are made of the same material and nearly identical shape. These differences are summarized in the following table: Model Feature Set ChambersSmall Antenna RF Capable Coated Evia SR Evia 1 Evia SR-T Evia 1 √ √ Evia DR Evia 2 Evia DR-T Evia 2 √ Evia SR coated Evia 1 √ Evia SR-T coated Evia 1 √ √ √ Evia DR coated Evia 2 √ Evia DR-T coated Evia 2 √ √ Entovis SR Entovis 1 Entovis SR-T Entovis 1 √ √ Entovis DR Entovis 2 Entovis DR-T Entovis 2 √ Entovis SR coated Entovis 1 √ Entovis SR-T coated Entovis 1 √ √ √ Entovis DR coated Entovis 2 √ Entovis DR-T coated Entovis 2 √ √ Antenna Information and Specifications for each antenna are part of this filing. The PRIMUS antenna is described in the following exhibits: 17_PRIMUS AntSpec.pdf The PRIMUS small antenna is described in the following two files: R5_PRIMUS Antenna Information small.pdf R5_PRIMUS Antenna Specification small.pdf These documents contain sketches and dimensions of the respective antennas, along with antenna gain, antenna materials and antenna header information. Item 3: 3) At two places minimum, the SAR analysis considers 30-minute time interval and/or time averaging. Per 47 CFR 2.1093(d)(5) such time-averaging provisions may not be used in determining typical exposure levels for portable devices used by consumers. Please revise SAR analysis accordingly. Answer to Item 3: An updated SAR Report, Primus SAR Analysis 3147205e.pdf has been uploaded as part of this filing. This SAR Report removes any references to time-averaging. This SAR report shows that the Primus pacemaker’s maximum worst-case SAR is 2.5218e-003 W/kg, averaged over 1 gram of tissue. The regulatory limit specified in 47 CFR 2.1093 is 1.6 Watts/kg, averaged over 1 gram of tissue. As such, the Primus pacemaker’s SAR level complies with the FCC regulatory limit with a margin of 28 dB. Item 4: 4) if not in filing already, please amend to provide details about transmitter (feedpoint) impedance obtained from SAR computation; as part of this please include e.g. return loss data to demonstrate appropriate operating frequency for antenna as modelled, etc. Answer to Item 4: As described in Section 8.2 of the revised SAR Report (Primus SAR Analysis 3147205e.pdf), the transmitter feedpoint impedance was obtained by the direct measurement of the transmitter's output impedance using an Agilent 8753ES RF Network Analyzer. For this measurement, the network analyzer was calibrated using an Agilent/HP 85033D calibration kit. The ultra-low power transmitter was active during the measurement of its output impedance, which was measured to be Z = 410 +j 63 Ohms at the transmitter's operating frequency. Item 5: 5) if not in filing already, please provide specific details for all model input source parameters and excitation signal type(s) Answer to Item 5: The specific details for all module input source parameters and excitation signal type(s) are shown in section 8.2 of the revised SAR report Report (Primus SAR Analysis 3147205e.pdf) . For the SAR analysis, the input source was modeled as a Thevenin equivalent circuit based upon measurements of the transmitter's output power and output impedance. The source model in the SAR analysis consisted of a sinusoidal continuous wave (CW) signal at…

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Test Report No.: G0M20810-2039-T-47 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Annex A Pictures Test Report No.: G0M20810-2039-T-47 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany

BIOTRONIK Telefon (+49 30) 689 05-0 Geschäftsführer: Kommanditgesellschaft: Meß- und Therapiegeräte Telefax (+49 30) 689 05-655 Dr. Max Schaldach HRA 6501, AG Berlin- Charlottenburg GmbH & Co KG. E-mail: [email protected] Christoph Böhmer Komplementärin: BIOTRONIK GmbH Woermannkehre 1 www.biotronik.de Dr. Lothar Krings HRB 2918, AG Berlin- Charlottenburg D-12359 Berlin Dr. Werner Braun BIOTRONIK GmbH & Co KG. • Postfach 47 02 55 • 12311 Berlin, Germany Federal Communications Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 Berlin, 2010-01-04 Re: Statement to the FCC ID: FCC ID: QRIPRIMUS Labeling Scheme Per 47 CFR 2.926 (e), “Where it is shown that a permanently affixed nameplate is not desirable or is not feasible, an alternative method of positively identifying the equipment may be used if approved by the Commission. The proposed alternative method of identification and the justification for its use must be included with the application for equipment authorization. Note: As an example, a device intended to be implanted within the body of a test animal or person would probably require an alternate method of identification.” Since the EUT is implanted in the human body, the FCC ID will not be applied to outside of the device. Instead, the applicant is proposing the following alternate method of applying the FCC ID number to two locations: 1. The FCC ID, along with the disclosure statement required by 95.1215, is in the User Ma- nual, page 47. 2. The FCC ID also appears on the package label, which is affixed to outside of the shipping box for a Primus device. Sincerely Andreas Gute Program Manager

Technical Report 3147205 Primus SAR Analysis Rev. B Page 1 of 9 Letter Revisions Date Approval A Original 13-11-2008 BPS B Correct doc. Number on pages 2 through 9 20-11-2008 BPS 1 Purpose The purpose of this report is to document the Specific Absorption Rate (SAR) computational analysis of the Biotronik Primus pacemaker. 2 Conclusion The Primus pacemaker, employing an ultra-low power RF transmitter, complies with the SAR regulatory limits specified in 47 CFR 95.603, §2.1093, and §1.1310. The Primus pacemaker’s maximum worst-case, time-averaged SAR is 4.79 μWatts/kg, averaged over 1 gram of tissue. The regulatory limit specified in 47 CFR 2.1093 is 1.6 Watts/kg, averaged over 1 gram of tissue. As such, the Primus pacemaker’s SAR is 55.2 dB below the maximum allowable regulatory limit specified by the FCC. 3 Applicability This report is applicable to all Primus pacemaker’s that use the same MICS RF transmitter circuitry and antenna structure noted in this report. 4 Document History Ver. A 13-11-2008 Initial Release 5 References 47 CFR 95.603 Certification Required 47 CFR 2.1093 Radio Frequency Radiation Exposure Evaluation: Portable Devices 47 CFR 1.1310 Radio Frequency Radiation Exposure Limits. 6 Definitions MICS Medical Implant Communications Service Periodic Transmission Infrequent RF signal transmission, on a periodic basis, from a transmitter to a receiver. Max-Hold Instrument display mode that indicates and displays the maximum detected signal level. Conducted Measurements Electrical measurements made using hardwire connections (not antennas) to the DUT DUT Device Under Test 7 Test Equipment The following equipment was used to perform the tests outlined in this report. ITEM DESCRIPTION MFGR. MODEL SERIAL NUMBER CALIBRATION DATE CALIBRATION DUE DATE IMP Implant module (Device Under Test) Biotronik Primus 06082200-03-D 358212 N/A N/A SA RF Spectrum Analyzer Rohde & Schwarz FSL 616 100288 14-05-2008 31-05-2009 SENSOR RF Power Meter Sensor Agilent 8481A MY41095529 16-05-2008 31-05-2009 PM Power Meter/Freq Counter Agilent 53147A US40470964 16-05-2008 31-05-2009 NET RF Network Analyzer Agilent 8753ES US39170321 28-07-2008 31-07-2009 CALKIT 3.5 mm Calibration Kit Agilent 85033D 3423A04725 14-11-2005 14-11-2008 CABLES RF Cables, 50 Ohm Coax Pasternack Assorted N/A N/A N/A Technical Report 3147205 Primus SAR Analysis Rev. B Page 2 of 9 with SMA connectors 7.1 Photograph of the Primus pacemaker Figures 7.1.1 and 7.1.2 are photos of the Biotronik Primus pacemaker. The loop antenna, embedded near the perimeter of the epoxy header, is evident in Figure 7.1.2. Figure 7.1.1 Front view of the Primus Pacemaker. Figure 7.1.2 Rear view of the Primus pacemaker. 8 Primus’ Specific Absorption Rate (SAR) Analysis Biotronik pacemakers utilize an ultra-low power RF transmitter to send a patient’s cardiac medical condition to a physician for evaluation. The amount of radiated power absorbed by the human body using this technology can be defined by a measure termed the Specific Absorption Rate (SAR). ANSI, and the IEEE, have defined the maximum SAR levels that can be safely used in these applications, and these limits are included in the FCC regulations for Medical Implant Communications Service (MICS). Certification of medical-implant transmitters under the FCC Part 95 MICS requires a measurement or Finite Difference Time Domain (FDTD) computational analysis of the SAR associated with the presence of non-ionizing radio frequency (RF) transmissions. This report details the SAR computational analysis for the ultra-low power RF transmitter employed in the Primus pacemaker. 8.1 Method of SAR Analysis The computational software used for this FDTD analysis was Remcom XFDTD Version 6.5.14.6. This software was used to convert a Biotronik 3-dimensional CAD engineering model of the pacemaker to a 3D rectangular-grid FDTD computational space. Technical Report 3147205 Primus SAR Analysis Rev. B Page 3 of 9 Adaptive cell-size meshing was employed in the FDTD computational space to achieve accurate modeling while also maintaining a reasonable limit on the computational memory requirements. To accurately model the SAR, a maximum cell size of 0.5 mm was used; except in the region of the antenna structure where the cell size was further reduced to 0.05 mm. As the cell size is extremely small, it is not practical to include a model of the upper human torso in the analysis. However, since previous experience using XFDTD modeling has shown that the region of maximum SAR is concentrated very near the antenna structure, the region surrounding the pacemaker was modeled using a material simulating the dielectric properties of human muscle at 403.5 MHz. As such, the computational model used in this study was restricted to 2 cm of muscle tissue surrounding the implant, and this resulted in a computational analysis encompassing approximately 38.5 million cells. To eliminate reflections at the boundary of the modeled space, the region beyond the meshed volume was modeled using perfectly matched layers (PML absorbing boundary). Figure 8.1.1 below shows a 3D view of the SAR computational space, and the loop antenna in the Primus pacemaker header can be clearly identified. The computational space used was 9.3 x 8.5 x 4.8 cm 3 , or approximately 379.4 cm 3 . This volume is more than sufficient for computing 1gram average SAR levels as required by the FCC. Figure 8.1.1 3D view of the Primus pacemaker embedded in tissue material for the SAR analysis. The use of a small cell size allowed all the elements of the header and antenna structure to be realized and accurately modeled with “non-thin” FDTD elements. The transmitter’s RF power and impedance, used to drive the antenna, were determined by the measurements outlined in Section 8.2. The material electrical properties used in the SAR analysis were obtained from either published data or direct measurement using a dielectric probe. Specifically, the relative dielectric constant of the header …

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Technical Report 3147205 Primus SAR Analysis Rev. C Page 1 of 9 Letter Revisions Date Approval A Original 13-11-2008 BPS B Correct doc. Number on pages 2 through 9 20-11-2008 BPS C Updated references to FCC regulations 04-01-2010 BPS 1 Purpose The purpose of this report is to document the Specific Absorption Rate (SAR) computational analysis of the Biotronik Primus pacemaker. 2 Conclusion The Primus pacemaker, employing an ultra-low power RF transmitter, complies with the SAR regulatory limits specified in 47 CFR 95.1221, §2.1093, and §1.1307(b)(2). The Primus pacemaker’s maximum worst-case, time- averaged SAR is 4.79 μWatts/kg, averaged over 1 gram of tissue. The regulatory limit specified in 47 CFR 2.1093 is 1.6 Watts/kg, averaged over 1 gram of tissue. As such, the Primus pacemaker’s SAR is 55.2 dB below the maximum allowable regulatory limit specified by the FCC. 3 Applicability This report is applicable to the Primus family of pacemakers that use the same MedRadio RF transmitter circuitry and antenna structure noted in this report. 4 Document History Ver. A 13-11-2008 Initial Release Ver. B 20-11-2008 Corrected doc. Number on pages 2 through 9 Ver. C 04-01-2010 Updated per FCC correspondence 5 References 47 CFR 95.1221 RF Exposure 47 CFR 2.1093 Radio Frequency Radiation Exposure Evaluation: Portable Devices 47 CFR 1.1310 Radio Frequency Radiation Exposure Limits. 6 Definitions MedRadio Medical Device Radiocommunication Service Periodic Transmission Infrequent RF signal transmission, on a periodic basis, from a transmit…

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