QRITACHNXTimplantable cardioverter defibrillator

Ilesto xxx xxx xxx ICD Familie • Tachyarrhythmietherapie • Kardiale Resynchronisationstherapie xxx xxx xxx xxx xxx xxx xxx xxx Technical Manual Technická příručka Brugermanual Gebrauchsanweisung Manual técnico Käyttöohje Manuel technique Manuale tecnico di istruzione Gebruikshandleiding Instrukcja obsługi Manual técnico Bruksanvisning • en • cs • da • de • es • fi • fr • it • nl • pl • pt • s v 393468--B_GA_Ilesto-II_mul-01xx_Cover.indd 127.09.2012 15:44:48 BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin · Germany Tel +49 (0) 30 68905-0 F ax +49 (0) 30 6852804 [email protected] www.biotronik.com 12-D-xx Revision: B (2012-xx-xx) © BIOTRONIK SE & Co. KG All rights reserved. Specifications subject to modification, revision and improvement. ® BIOTRONIK Home Monitoring, IEGM-Online HD and SMART Detecton are registered trademarks of BIOTRONIK SE & Co. KG 0123 0681 2012 393468--B_GA_Ilesto-II_mul-01xx_Cover.indd 227.09.2012 15:44:48 1 Ilesto 5/7 VR-T, VR-T DX, DR-T, HF-T ICD Family Tachyarrhythmia Therapy Cardiac Resynchronization Therapy Technical Manual for the Device Doc. Id.: GA-HW_en--mul_393468-B Index GA-HW_en--mul_393468-BTechnical[nbsp ]Manual for the[nbsp ]DeviceIlesto 5/7 VR-T, VR-T DX, DR-T, HF-T 2 3Table of Contents Table of Contents Table of Contents Product Description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Intended Medical Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Therapeutic and Diagnostic Functions. . . . . . . . . . . . . . . . . 11 General Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Operating Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Possible Complications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Possible Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Implantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Implantation Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Precautionary Measures while Programming . . . . . . . . . . 21 Magnet Response. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Follow-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Patient Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Replacement Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Explantation and Device Replacement. . . . . . . . . . . . . . . . . 28 Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Bradycardia / CRT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Tachycardia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Sensing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Home Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Mechanical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . 39 Electrical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Battery Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Legend for the Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 4Table of Contents 5Product Description 1Product Description Product Description1GA-HW_en--mul_393468-BTechnical[nbsp ]Manual for the[nbsp ]DeviceIlesto 5/7 VR-T, VR-T DX, DR-T, HF-T Intended Medical Use Intended useIlesto 5/7 is part of a familiy of implantable cardioverter-defibrillators (ICDs). Primary objective of the therapy is to prevent sudden cardiac death. Furthermore, the device is capable of treating bradycardia arrhythmias and cardiac resynchroni- zation therapy with multisite ventricular pacing. The implantation of an ICD is a symptomatic therapy with the following objectives: •Termination of spontaneous ventricular fibrillation (VF) through shock delivery •Termination of spontaneous ventricular tachycardia (VT) through antitachy- cardia pacing (ATP); in case of ineffective ATP or hemodynamically not toler- ated VT, with shock delivery •Cardiac resynchronization through multisite ventricular pacing (triple- chamber devices) •Compensation of bradycardia through ventricular (single-chamber devices) or AV sequential pacing (DX, dual- and triple-chamber devices) Diagnosis and therapy forms The device monitors the heart rhythm and automatically detects and terminates cardiac arrest resulting from ventricular tachyarrhythmia. All major therapeutic approaches from the field of cardiology and electrophysiology are included. BIO- TRONIK Home Monitoring ® enables physicians to perform therapy management at any time. Required expertiseIn addition to having basic medical knowledge, the user must be thoroughly familiar with the operation and the operation conditions of a device system. •Only qualified medical specialists having this special knowledge required are permitted to use implantable devices. •If users do not possess this knowledge, they must be trained accordingly. 6Product Description IndicationsIlesto can treat life-threatening ventricular arrhythmias with antitachycardia pacing and defibrillation. Generally approved differential diagnostics methods, indications, and recommen- dations for ICD therapy apply to BIOTRONIK devices. See the guidelines of cardi- ology associations for guidance. We recommend observing the indications published by the German Cardiac Society (Deutsche Gesellschaft für Kardiologie, Herz- und Kreislaufforschung) and the ESC (…

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

Iforia ICD Family • Tachyarrhythmia Therapy • Cardiac Resynchronization Therapy xxx xxx ICD Familie • Tachyarrhythmietherapie • Kardiale Resynchronisationstherapie xxx xxx xxx xxx xxx xxx xxx xxx Technical Manual Technická příručka Brugermanual Gebrauchsanweisung Manual técnico Käyttöohje Manuel technique Manuale tecnico di istruzione Gebruikshandleiding Instrukcja obsługi Manual técnico Bruksanvisning • en • cs • da • de • es • fi • fr • it • nl • pl • pt • sv ( ) 393467--B_GA_Iforia-I-ProMRI_mul-01xx_Cover.indd 125.10.2012 17:51:48 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 12-D-xx Revision: B (2012-xx-xx) © BIOTRONIK SE & Co. KG All rights reserved. Specifications subject to modification, revision and improvement. ® BIOTRONIK Home Monitoring, (ProMRI), IEGM-Online HD and SMART Detecton are registered trademarks of BIOTRONIK SE & Co. KG 0123 0681 2012 393467--B_GA_Iforia-I-ProMRI_mul-01xx_Cover.indd 225.10.2012 17:51:48 en • English .................................................................................................................................................................2 de • Deutsch ................................................................................................................................................................24 393467--B 393467--B_GA_Iforia_ProMRI_mul-02.book Page 1 Friday, November 16, 2012 11:18 AM 2 en • English Product Description Intended Medical Use Intended use Iforia 3/5/7 is part of a family of implantable cardioverter-defibrillators (ICDs). Primary objective of the therapy is to prevent sudden cardiac death. Furthermore, the device is capable of treating bradycardia arrhythmias and cardiac resynchronization therapy with multisite ventricular pacing. The implantation of an ICD is a symptomatic therapy with the following objectives: •Termination of spontaneous ventricular fibrillation (VF) through shock delivery •Termination of spontaneous ventricular tachycardia (VT) through antitachycardia pacing (ATP); in case of ineffective ATP or hemodynamically not tolerated VT, with shock delivery •Cardiac resynchronization through multisite ventricular pacing (triple-chamber devices) •Compensation of bradycardia through ventricular (single-chamber devices) or AV sequential pacing (DX, dual- and triple-chamber devices) Diagnosis and therapy forms The device monitors the heart rhythm and automatically detects and terminates cardiac arrest resulting from ventricular tachyarrhythmia. All major therapeutic approaches from the field of cardiology and electrophysiology are included. BIOTRONIK Home Monitoring ® enables physicians to perform therapy management at any time. Required expertise In addition to having basic medical knowledge, the user must be thoroughly familiar with the operation and the operation conditions of a device system. •Only qualified medical specialists having this special knowledge required are permitted to use implantable devices. •If users do not possess this knowledge, they must be trained accordingly. Indications Iforia can treat life-threatening ventricular arrhythmias with antitachycardia pacing and defibrillation. Generally approved differential diagnostics methods, indications, and recommenda- tions for ICD therapy apply to BIOTRONIK devices. See the guidelines of cardiology associations for guidance. We recommend observing the indications published by the German Cardiac Society (Deutsche Gesellschaft für Kardiologie, Herz- und Kreislaufforschung) and the ESC (European Society of Cardiology). This also applies to the guidelines published by the Heart Rhythm Society (HRS), the American College of Cardiology (ACC), the American Heart Association (AHA), and other national cardiology associations. Single-chamber and dual-chamber Single-chamber and dual-chamber ICDs are indicated for patients with the following risk: •Sudden cardiac death caused by ventricular arrhythmias Triple-chamber Triple-chamber ICDs are indicated for patients with the following risks: •Sudden cardiac death caused by ventricular arrhythmias •Congestive heart failure with ventricular asynchrony Iforia is also indicated for primary prophylaxis in congestive heart failure patients. Contraindications Known contraindications: •Tachyarrhythmia caused by temporary or reversible irritation, e.g. poisoning, electrolyte imbalance, hypoxia, sepsis or acute myocardial infarction •Such frequent VT or VF that the therapies would cause an unacceptably rapid depletion of the device batteries •VT with few or without clinically relevant symptoms •VT or VF treatable by surgery •Concomitant diseases that would substantially limit a positive prognosis •Accelerated idioventricular rhythm System Overview Device family The complete Iforia 3/5/7 device familyconsists of several device types with a DF-1/IS-1connection. Single-chamber: VR-T and VR-T DX (only devices with a DF-1/IS-1 connection); dual-chamber: DR-T; triple-chamber: HF-T. Not all device types are available in every country. 393467--B_GA_Iforia_ProMRI_mul-02.book Page 2 Friday, November 16, 2012 11:18 AM en • English3 Device The device's housing is made of biocompatible titanium, welded from outside and thus hermetically sealed. The ellipsoid shape facilitates implantation in the pectoral muscle area. The connections for bipolar pacing and sensing (and unipolar connections for the triple-chamber device) as well as for shock delivery are found in the device header. The housing serves as a potential antipole during shock delivery or in the case of unipolar lead configuration. DF-1/IS-1 lead connection The device labeling provides information pertaining to possible lead connections depending on the device type and pertaining to connection assignment: Leads BIOTRONIK leads are sheathed with biocompatible silicone. They can be flexibly maneuvered, are stable long-term, and are equipped for active or passive fi…

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

Federal Communications Commission Authorization and Evaluation Division Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 To whom it may concern: ~ BIOTRONIK excellence for life 7/20/2012 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: QRITACHNXT 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 53 01 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862. Sincere!~ Signature Dipl.-lng. Hussein Halawi Manager Regulatory Affairs BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin, Germany Phone: +49 (0) 30 68905-1227 Fax : +49 (0) 30 68905-1921 Mail: [email protected] \

Federal Communications Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 Request for Confidentiality Company name: BIOTRONIK SE & Co. KG FCC 10: QRITACHNXT FCC Part 15 Certification To whom it may concern, ~ BIOTRONIK excellence for life 7/20/2012 In accordance with 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 re lease 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. Signature Dipl.-lng. Hussein Halawi Manager Regulatory Affairs BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin, Germany Phone: +49 (0) 30 68905-1227 Fax : +49 (0) 30 68905-1921 Mail: [email protected]

version: 04 22_TACHNXT FamListDecl_newFCC_final page 1 / 1 Family Certification List of Models to be included in the family (1) Applicant: BIOTRONIK SE & CO. KG (2) Certification Number: QRITACHNXT Product Name Type Connector Description of Differences 1 Ilesto 7 HF-T CRT DF-1 / DF-4 3-chamber CRT ICD, 40 J max. stored Energy 2 Ilesto 7 DR-T DR DF-1 / DF-4 2-chamber ICD, 40 J max. stored Energy 3 Ilesto 7 VR-T DX DX DF-1 single-chamber ICD with additional sensing in Atrium, 40 J max stored energy 4 Ilesto 7 VR-T VR DF-1 / DF-4 single-chamber ICD, 40 J stored energy 5 Iforia 7 HF-T CRT DF-1 / DF-4 3-chamber CRT ICD, 40 J max. stored Energy 6 Iforia 7 DR-T DR DF-1 / DF-4 2-chamber ICD, 40 J max. stored Energy 7 Iforia 7 VR-T DX DX DF-1 single-chamber ICD with additional sensing in Atrium, 40 J max stored energy 8 Iforia 7 VR-T VR DF-1 / DF-4 single-chamber ICD, 40 J stored energy 9 Ilesto 5 HF-T CRT DF-1 / DF-4 3-chamber CRT ICD, 40 J max. stored Energy 10 Ilesto 5 DR-T DR DF-1 / DF-4 2-chamber ICD, 40 J max. stored Energy 11 Ilesto 5 VR-T DX DX DF-1 single-chamber ICD with additional sensing in Atrium, 40 J max stored energy 12 Ilesto 5 VR-T VR DF-1 / DF-4 single-chamber ICD, 40 J stored energy 13 Iforia 5 HF-T CRT DF-1 / DF-4 3-chamber CRT ICD, 40 J max. stored Energy 14 Iforia 5 DR-T DR DF-1 / DF-4 2-chamber ICD, 40 J max. stored Energy 15 Iforia 5 VR-T DX DX DF-1 single-chamber ICD with additional sensing in Atrium, 40 J max stored energy 16 Iforia 5 VR-T VR DF-1 / DF-4 single-chamber ICD, 40 J max stored energy 17 Iforia 3 HF-T CRT DF-1 / DF-4 3-chamber CRT ICD, 40 J max. stored Energy 18 Iforia 3 DR-T DR DF-1 / DF-4 2-chamber ICD, 40 J max. stored Energy 19 Iforia 3 VR-T VR DF-1 / DF-4 single-chamber ICD, 40 J max stored energy 20 Idova 7 HF-T CRT DF-1 / DF-4 3-chamber CRT ICD, 45 J max. stored Energy 21 Idova 7 DR-T DR DF-1 / DF-4 2-chamber ICD, 45 J max. stored Energy 22 Idova 7 VR-T DX DX DF-1 single-chamber ICD with additional sensing in Atrium, 45 J max stored energy 23 Idova 7 VR-T VR DF-1 / DF-4 single-chamber ICD, 45 J stored energy 24 Innotix 7 HF-T CRT DF-1 / DF-4 3-chamber CRT ICD, 45 J max. stored Energy 25 Innotix 7 DR-T DR DF-1 / DF-4 2-chamber ICD, 45 J max. stored Energy 26 Innotix 7 VR-T DX DX DF-1 single-chamber ICD with additional sensing in Atrium, 45 J max stored energy 27 Innotix 7 VR-T VR DF-1 / DF-4 single-chamber ICD, 45 J stored energy There are no differences with respect to the RF-part between products. The different configurations only offer additional diagnostics but uses identical RF electronic and antenna.

Federal Communications Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 ~ BIOTRONIK excellence for life 8/14/2012 Request for Short Term Confidentiality, intended to allow importation I distribution of authorized equipment while maintaining confidentiality before product launch Company name: BIOTRONIK SE & Co. KG FCC 10: QRITACHNXT FCC Part 15 Certification Gentlemen, In accordance with 0.457 and 0.459 of CFR 47, BIOTRONIK SE & Co. KG hereby requests for 'Short Term Confidentiality' of all • External Photos, • Test Setup Photos, • User's Manual, • Internal Photos, 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 to its competitors and that the disclosure of the information in these documents would give competitors an unfair advantage in the market. ~~ Signature Hussein Halawi Manager Regulatory Affairs BIOTRONIK SE & Co. KG

B!OTRONIK SE & Co. KG · Postfach 470255 · 12311 Berlin To: Federal Communications Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 Statement to the FCC ID: QRITACHNXT Labeling Scheme Per 47 CFR 2.926 (e) ~ BIOTRONIK excellence for life BIOTRONIK SE & Co . KG Woermannkehre 1 12359 Berlin, Germany Tel +49 (0) 30 68905-1227 Fax +49 (0) 30 68905-1921 [email protected] www.biotronik.com Berlin, August 20, 2012 "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 OUT 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 (a), is in the user manual. 2. The FCC ID also appears on the package label which is affixed to outside of the shipping box for the TACH NXT device. Sincerely, BIOTRONIK SE & Co. KG Hussein Halawi Manager Regulatory Affairs B!OTRON!K SE & Co. KG Woermannkehre 1 12359 Berlin Steuer-Nr.: 30/062/05167 USt.-ldent Nr.: DE136651322 Tel +49 (0) 30 68905-0 Fax +49 (0) 30 6844060 [email protected] www.blotronik.com Gesch~ftsfOhrende Direktoren: Christoph BOhmer Dr. Werner Braun Dr. Lothar Krings Dr. Torsten Wolf Kommanditgesellschaft: H RA 6501, AG Berlln-Charlottenburg Komplementarin: BI DTRDNI K MT SE HRB 118866 B, AG Berlln-Charlottenburg

Tach_NXT / RF submission / pictures Inner assembly: DUT - electronic module with mounting frame – top view DUT - electronic module with mounting frame – bottom view DUT - electronic module with mounting frame placed in half can – top view DUT - electronic module with mounting frame placed in half can with battery (left) and HV cap’s (right) – top view DUT – electronic module before it is cut out and folded to be mounted in the mounting frame -- top view DUT – electronic module before it is cut out and folded to be mounted in the mounting frame -- bottom view

Tach NXT SAR Analysis RECORD ID GTR-12-0333-B RELEASE DATE 08-MARCH-2013 TYPE RECORD – LEVEL 4 FORM FOR-0043 The information in this document is proprietary to Micro Systems Engineering, Inc. It may not be used, reproduced or disclosed without prior approval of Micro Systems Engineering, Inc. GTR-12-0333-B Tach NXT SAR Analysis The information in this document is proprietary to Micro Systems Engineering, Inc. It may not be used, reproduced or disclosed without prior approval of Micro Systems Engineering, Inc. Confidentiality Class Type Form No. Rev. Change Notice Pages Confidential Document – Level 3 FOR-0043 B 12-0252 2/13 Table of Contents 1 PURPOSE........................................................................................................................................3 2 STATEMENT OF COMPLIANCE......................................................................................................3 3 SAR SUMMARY...............................................................................................................................3 4 APPLICABILITY...............................................................................................................................4 5 DOCUMENT HISTORY.....................................................................................................................4 6 REFERENCES..................................................................................................................................4 7 DEFINITIONS...................................................................................................................................4 8 TEST EQUIPMENT...........................................................................................................................4 8.1 VARIANTS OF THE TACH NXT ICD.....................................................................................4 9 SPECIFIC ABSORPTION RATE (SAR) ANALYSIS..........................................................................5 9.1 METHOD OF SAR ANALYSIS..............................................................................................6 9.2 RF TRANSMITTER PARAMETERS......................................................................................8 9.3 SAR COMPUTATIONAL ANALYSIS.....................................................................................8 9.4 WORST-CASE SAR EXPOSURE.......................................................................................10 10 APPROVAL AND SIGNATURES....................................................................................................13 GTR-12-0333-B Tach NXT SAR Analysis The information in this document is proprietary to Micro Systems Engineering, Inc. It may not be used, reproduced or disclosed without prior approval of Micro Systems Engineering, Inc. Confidentiality Class Type Form No. Rev. Change Notice Pages Confidential Document – Level 3 FOR-0043 B 12-0252 3/13 1 PURPOSE The purpose of this report is to document the Specific Absorption Rate (SAR) computational analysis of the Biotronik Tach NXT implantable cardioverter defibrillator (ICD). 2 STATEMENT OF COMPLIANCE The Tach NXT implant, employing an ultra-low power RF transmitter, complies with the SAR regulatory limits specified in 47 CFR 95.1221, §2.1093, and §1.1310. The Biotronik Tach NXT’s maximum worst-case SAR is 10.34 mW/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 implant’s SAR level complies with the FCC regulatory limit with a margin of 21.9 dB. 3 SAR SUMMARY The following is a summary of the Tach NXT SAR analyses reported in this document. 1. Two SAR analyses were performed – one for each variant of the Tach NXT ICD. 2. The two Tach NXT physical models used in the SAR analyses were derived directly from Biotronik 3- dimensional engineering CAD files. 3. The SAR analyses were performed using the Finite Difference Time Domain (FDTD) method as required by the FCC. The FDTD simulation software used in the analyses was Remcom Bio-pro XFDTD version 7.2.3.4 4. The SAR analyses were performed with the implant surrounded by a cube of material with dielectric properties identical to human muscle tissue at 403.5 MHz (Er = 57.9 and s = 0.82 S/m). The human muscle dielectric properties were obtained from the FCC OET web site for RF Safety: Body Tissue Dielectric Parameters Tool. 5. The simulated muscle tissue surrounding the implant extended beyond the implant by 2 cm. The region extending beyond the simulated muscle tissue was modeled as a perfectly absorbing boundary. 6. The SAR analyses were performed using adaptive meshing to resolve antenna features as small as 0.03 mm. 7. Remcom XFDTD reported this mesh size would result in accurate modeling to 59.96 GHz. 8. Each SAR analysis encompassed a volume space comprised of approximately 69 million cells. 9. The time step in the FDTD simulation was 52 fs. 10. The analyses were performed using a sinusoidal source at 403.5 MHz (the center frequency of the 402 MHz to 405 MHz MedRadio band). Duty cycle was 100%. 11. The transmitter output power was measured using a calibrated Agilent RF power meter. 12. The transmitter output impedance was measured using a calibrated Agilent RF network analyzer. 13. The maximum SAR exposure occurred in the immediate vicinity of the implant, well within the volume of the simulated muscle tissue. 14. The SAR simulation attained better than –30 dB convergence. 15. A worst-case analysis was performed on the larger of the two reported SAR results. The worst-case SAR was computed for the worst-case RF transmitter power and output impedance. This added 0.665 dB to the computed SAR exposure. 16. The worst-case 1-gram averaged SAR is 10.34 mW/kg. 17. The Tach NXT ICD worst-case 1-gram averaged SAR is below the FCC regulatory limit of 1.6 W/kg by a margin of 21.9 dB. GTR-12-0333-B Tach NXT SAR Analysis The information in this docum…

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

Test Report No.: G0M-1207-2110-TFC95IM-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany FCC TEST REPORT FCC 47 CFR Part 95I Medical Device Radiocommunication Service (MedRadio) Industry Canada RSS-243 Medical Devices Operating in the 401 – 406 MHz Frequency Band Report Reference No. .................... : G0M-1207-2110-TFC95IM-V01 Testing Laboratory ........................ : Eurofins Product Service GmbH Address ............................................ : Storkower Str. 38c 15526 Reichenwalde Germany Accreditation .................................... : A2LA Accredited Testing Laboratory, Certificate No.: 1983.01 FCC Filed Test Laboratory, Reg.-No.: 96970 IC OATS Filing assigned code: 3470A Applicant’s name ........................... : BIOTRONIK SE & Co. KG Address ............................................ : Woermannkehre 1 12359 Berlin GERMANY Test specification: Standard ........................................... : 47 CFR Part 95E 47 CFR Part 95I 47 CFR Part 15C RSS-243, Issue 3, 2010-02 RSS-Gen, Issue 3, 2010-12 ANSI C63.4:2009 EN 301 839-1 V1.3.1:2009-10 Equipment under test (EUT): Product description ICD / Implantable Cardioverter Defibrillator Model No. Ilesto 7 HF-T Hardware version Rev.: 0B Firmware / Software version ROM: 2.3 / RAM: 2.0 FCC-ID: QRITACHNXT IC: 4708A-TACHNXT Test result Passed Page 1 of 82 Page 2 of 82 Test Report No.: G0M-1207-2110-TFC95IM-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Additional comments: The report applies to all model stated in the “TACH NXT Family Listing” issued by the Manufacturer 2012-09- 19. The ulp-ami antenna is built into the headers (DF-1 or DF-4). The antenna of header model DF-1 is slightly different from the antenna built into header DF-4. Evaluation measurements were performed for worst case antenna selection and header DF-1 was selected. Besides the DF-1 header, model ILESTO 7 HF-T, as the most complex model, was selected for the measurements. Hence, the measurements were performed with the following model: “ILESTO 7 HF-T DF-1”. Page 3 of 82 Test Report No.: G0M-1207-2110-TFC95IM-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany REPORT INDEX 1 EQUIPMENT (TEST ITEM) DESCRIPTION 5 Photos - Equipment external 6 1.1 Photos - Equipment internal 13 1.2 Photos – Test setup 14 1.3 Supporting Equipment Used During Testing 15 1.4 Test Modes: 16 1.5 Test Equipment Used During Testing 17 1.6 Sample emission level calculation 18 1.7 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 25 3.3 Test Conditions and Results – Frequency stability 29 3.4 Test Conditions and Results – Transmitter output power 31 3.5 Test Conditions and Results – Band-edge compliance 33 3.6 Test Conditions and Results – Transmitter unwanted emissions 35 3.7 Test Conditions and Results – Receiver spurious emissions 37 ANNEX A Transmitter radiated power 39 ANNEX B Transmitter band-edge 46 ANNEX C Transmitter radiated spurious emissions 55 ANNEX D Receiver radiated spurious emissions 76 Page 4 of 82 Test Report No.: G0M-1207-2110-TFC95IM-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany 1 Equipment (Test item) Description Description ICD / Implantable Cardiover…

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