QRILUMAXT50Implantable Cardioverter defibrillator

Lumax Family of Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators  VR ICD  VR-T ICD  VR-T DX ICD  DR ICD  DR-T ICD  HF CRT-D  HF-T CRT-D Technical Manual X-ray Identification Lumax Family Implantable Cardioverter Defibrillator and Cardiac Resynchronization Therapy Defibrillators Inside the housing: Belos Technical Manual iii Model X-Ray Identification Year of Manufacture Lumax 300 HR nn Lumax 340 HR nn Lumax 500 SH nn Lumax 540 SH nn Lumax 600 RH nn Lumax 640 RH nn Lumax 700 RH nn Lumax 740 RH nn CAUTION Federal (U.S.A.) law restricts this device to sale by, or on the order of, a physician. 2011 BIOTRONIK, Inc., all rights reserved. Lumax Technical Manual i Contents 1. General ..............................................................................1 1.1 System Description .......................................................1 1.2 Indications and Usage...................................................4 1.3 Contraindications...........................................................5 1.4 Warnings and Precautions ............................................5 1.4.1 Sterilization, Storage, and Handling ......................8 1.4.2 Device Implantation and Programming .................8 1.4.3 Lead Evaluation and Connection ........................10 1.4.4 Follow-up Testing ................................................12 1.4.5 Pulse Generator Explant and Disposal ...............12 1.4.6 Hospital and Medical Hazards.............................12 1.4.7 Home and Occupational Hazards .......................14 1.4.8 Cellular Phones ...................................................14 1.4.9 Electronic Article Surveillance (EAS) ..................15 1.4.10 Home Appliances ................................................15 1.4.11 Home Monitoring® ..............................................15 1.5 Potential/Observed Effects of the Device on Health ...17 1.5.1 Potential Adverse Events ....................................17 1.5.2 Observed Adverse Events...................................18 1.6 Clinical Studies ............................................................27 1.6.1 Kronos LV-T Study ..............................................28 1.6.2 Tupos LV/ATx Study............................................30 1.6.3 Lumax HF-T V-V Clinical Study...........................48 1.6.4 TRUST Clinical Study..........................................55 1.6.5 Deikos A+ ............................................................63 1.7 Patient Selection and Treatment .................................67 1.7.1 Individualization of Treatment .............................67 1.7.2 Specific Patient Populations ................................68 1.8 Patient Counseling Information ...................................68 1.9 Evaluating Prospective CRT-D/ICD Patients ..............69 2. Device Features ..............................................................70 2.1 SafeSync Telemetry ....................................................70 2.2 Cardiac Resynchronization Therapy (CRT) ................73 2.3 Sensing (Automatic Sensitivity Control) ......................76 2.3.1 Right Ventricular Sensitivity Settings...................77 2.3.2 Minimum Right Ventricular Threshold .................79 ii Lumax Technical Manual 2.3.3 Atrial Sensitivity Settings .....................................79 2.3.4 Minimum Atrial Threshold....................................80 2.3.5 Left Ventricular Sensitivity Settings .....................80 2.3.6 Minimum Left Ventricular Threshold....................81 2.3.7 Far Field Protection .............................................81 2.3.8 Additional Sensing Parameters ...........................81 2.4 Automatic Threshold Measurement (ATM) .................83 2.4.1 Signal Quality Check ...........................................84 2.4.2 Threshold Measurement .....................................84 2.4.3 Loss of Capture Detection ...................................84 2.4.4 ATM in Lumax HF-T Models ...............................84 2.4.5 RV & LV Capture Control ....................................85 2.5 Ventricular Tachyarrhythmia Detection........................85 2.5.1 VF Classifications ................................................86 2.5.2 VT Interval Counters............................................86 2.5.3 VT Classification..................................................86 2.5.4 SMART Detection™ ............................................87 2.5.5 Onset ...................................................................88 2.5.6 Stability ................................................................88 2.5.7 Sustained VT Timer.............................................88 2.5.8 VT Monitoring Zone .............................................89 2.5.9 Atrial Monitoring Zone .........................................89 2.6 Tachyarrhythmia Redetection......................................90 2.6.1 VT Redetection....................................................90 2.6.2 SMART Redetection............................................90 2.6.3 Forced Termination .............................................90 2.6.4 VF Redetection....................................................91 2.7 Tachyarrhythmia Termination ......................................91 2.8 Tachyarrhythmia Therapy............................................91 2.8.1 Therapy Options ..................................................91 2.8.2 Anti-Tachycardia Pacing (ATP) ...........................91 2.8.3 Shock Therapy ....................................................95 2.8.4 Progressive Course of Therapy.........................101 2.9 Bradycardia Therapy .................................................102 2.9.1 Bradycardia Pacing Modes ...............................102 2.9.2 Basic Rate .........................................................103 2.9.3 Night Rate..........................................................103 2.9.4 Rate Hysteresis .......…

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Joerg Kusig Von: Joerg Kusig Gesendet: Mittwoch, 23. Mai 2012 10:19 An: [email protected] Cc: Hussein Halawi; [email protected]; Sandra Henke; Andrea Lehmann Betreff: FCC Equipment Authorization System - Correspondence Reference Number: 41690 - 731 Confirmation Number: EA447863 Anlagen: Q1a - QRILUMAXT50 Ref 41690.jpg; Q1b - QRILUMAXT50 Ref 41690.jpg; Q2+3 - QRILUMAXT50 Ref 41690.pdf; Q8 - QRILUMAXT50 Ref 41690.jpg Page 1 of 3Please find 23.05.2012 Dear Mr Harrington, Please find the responses to your questions below in „blue” and in the attachment. The responses are arranged on behalf of the manufacturer and the lab which performed the measurement. The statements, pictures and drawings were made available by this parties. Best Regards! Sandra Henke The information transmitted is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any review, retransmission, dissemination or other use of, or taking of any action in reliance upon, this information by persons or entities other than the intended recipient is prohibited. If you received this in error, please contact the sender and delete the material from any computer. To: Gunnar Boersch, [email protected] From: Tim Harrington [email protected] FCC Equipment Authorization Branch Applicant: BIOTRONIK SE & Co. KG FCC ID: QRILUMAXT50 Correspondence Reference Number: 41690 731 Confirmation Number: EA447863 Date of Original E-Mail: 4/26/2012 Subject: FCC Equipment Authorization System 1) a) Unless it is already shown in the internal photos, please revise/amend to also show the MedRadio antenna, with the associated connections and chassis assembly components. 1) b) For internal photos, please explain and/or show what/where is the telemetry antenna coil Response to #1a/b The device has two antennas. Antenna size and location of the 402 to 405 MHz Med Radio are shown as a red line in the attached picture Q1a - QRILUMAXT50 Ref 41690.jpg. The second antenna is a low frequency 32 kHz telemetry antenna coil. Size and location are shown in the attached picture Q1b - QRILUMAXT50 Ref 41690.jpg. The 32 kHz telemetry system is designed for “very” near field communication. And is far below the 40dB under 15.209 limit line requirement. See also question #5 response. 2) a) Op. desc. mentions "TELEC T241"; as appropriate please revise to explain what that is, how is it relevant for FCC rule requirements, etc.; or revise to be only in terms of specific FCC requirements. 2) b) Op. desc. mentions "MICS" - fyi that term is obsolete in FCC rules. At minimum for ALL future filings, please ensure that all relevant exhibits are in terms of the most recent 47 CFR in effect at the time of application submission; i.e. use "Med Radio" not "MICS", see also part 95 section numbering changes per 77 FR 4252-4271 (FCC-11-176), etc. Response to #2a/b Please find a revised version of the operational description in the attachment Q2+3 - QRILUMAXT50 Ref 41690.pdf and delete the former version of the operational description. Eurofins Product Service GmbH Storkower Strasse 38C D-15526 Reichenwalde Germany (Phone) +49 33631 888 701 (Fax) +49 33631 888 640 mailto:[email protected] http://www.eurofins-reichenwalde.de http://www.eurofins.com http://product-testing.eurofins.com Managing Directors: Christian Keding Place of Business: Reichenwalde Registration Office: HRB 103428 3) Various exhibits seem to indicate this filing is intended to cover several different versions of implant transmitters. Various designations used herein include: "740 HF-T", "640 DR-T", "TACH50", "600/700", Unless in the filing already, please provide list and photos or engineering drawings for all versions intended under this FCC ID, and with brief description for what are differences for each, i.e. external dimensions, header configurations, etc. Response to #3 Please find a revised version of the operational description in the attachment Q2+3 - QRILUMAXT50 Ref 41690.pdf. It explains the model differences in detail. 4) Please identify specific and/or typical FCC ID(s) of other device(s) subject to FCC equipment authorization intended to operate together in a session with this implant transmitter as part of an inductive telemetry system. Response to #4 The Lumax implant works together with the programming and diagnostic system Renamic: FCC ID: QRIRENAMIC 5) Page 5 of the 15.209 test report appears to indicate this implant device has a telemetry transmit fundamental signal at 32 kHz. Pages 12-13 indicate a spurious emission measurement result at 48 kHz. Note that the 15.209(a) "emissions from an intentional radiator" provision includes also the fundamental signal. Unless in the filing already, as appropriate compliance to 15.209 limits also needs to be demonstrated for the 32 kHz emission [also 15.209(c), as appropriate]. Please explain and/or revise accordingly. In case the fundamental signal field strength is not 40 dB below the limit, then 15.201 requires Certification also for the intentional radiator portion; i.e. an additional form-731 (composite) application must be submitted, containing complete 2.1033(b) information. Response #5 After detailed consultation with the test lab we can confirm that because of the extrem near field transmission character of the inductive system the 32 kHz carrier and its harmonics, even in a three meter measurement distance, do no show up above the noise floor. The 32 kHz transmitter was active during the measurement and no notch filter was used to supress the 32 kHz carrier. Accordingly, the 32 kHz transmitter is more than 80 dB below the 15.209 limit line. The 48 kHz peak cannot be directly traced back to the inductive telemetry system and is generated by a different source. 6) Part 95 test report mentions 95.628 sections. This application was submitted March 19, 2012. FYI as of Feb. 27, 2012, 95.628 was renumbered to be 95.627. A revised test report is not required for t…

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Test Report No.: G0M21101-4127-C-2 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Annex A Photos EUT TOP EUT BOTTOM Page 13 of 18

VVE-DDDR 96 96 96969696 96 969696 9696 90 96 92 90 9090 90 90 90 90 90 91 909090 92 92 90 Use By Use By 90 Use By 90 Use By 90 9! 9! 92 9! DF-1 DF-1 DF-1 90 IS-1 IS-1 DF-1 DF-1 IS-1 IS-1 9! IS-1DF-1IS-1 30009 B B 403.6 MHz ð K ð K 89 UU I 89 U 8989 41-113 °F 89 2012-12 _X 89 2012-12 BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin - Germany BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin - Germany Tel +49 (0) 30 68905-0 Fax +49 (0) 30 6852804 [email protected] BIOTRONIK SE & Co. KGWoermannkehre 112359 Berlin - GermanyTel +49 (0) 30 68905-0Fax +49 (0) 30 [email protected] _X 8989 89 89 89 89 89 2012-12 2012-12 OFF OFF VVE-DDDR X VVE-DDDR VVE-DDDR Caution: Federal law (U.S.A.) restricts this device to sale by, oron the order of, a physican (or properly licenced practitioner) 381470 For single use only, do not resterilize. Refer to technical manual for instructions. ICD is shipped with all therapy disabled. X (01)04035479122874(17)121231(21)12345678 381470 123456781234567812345678 381470 1234567812345678 12345678 Cat. No. 12345678 Cat. No. 12345678 Cat. No. 12345678 Cat. No. 12345678 12345678 12345678 12345678 381470 12345678 (01)04035479122874(17)121231(21)12345678 QT 12345678 12345678 m 12345678 A m Æ ö 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) Programmable Parameter RangesValues at Factory ReleaseParameter Prod.ID Prod.ID Prod.ID Individual Data Sheet FCC ID: QRILUMAXT50 Lumax 640 DR-T Lumax 640 DR-T Lumax 640 DR-T Lumax 640 DR-T Bradycardia Therapy Mode 0.5...(0.25)...4...(0.5)...6; 7.5 Lumax 640 DR-T Stor.Temp. Serial No. Serial No. Serial No. Serial No. Prod.ID OFF; DEFIBRILLATION with/without Confirmation OFF; BURST; RAMP; SCAN 0.4; 0.5...(0.25)...1.5 30...(5)...100...(10)...160 Lumax 640 DR-T Lumax 640 DR-T Pulse Amplitude; V RH X-Ray Identification OFF Shock OFF ATPs Pulse Width; ms Basic Rate; min-1 Lumax 640 DR-T AAI(R); V00; VVI(R); VDI(R); VDD(R); D00; DDI(R); DDD(R); OFF For single use only, do not resterilize. Do not use if packaging is damaged. Refer to technical manual for instructions. ICD is shipped with all therapy disabled. OFF Sterilized with ethylene oxide Lumax 640 DR-T Implantable Cardioverter Defibrillator Lumax 640 DR-T Implantable Cardioverter Defibrillator Implantable Cardioverter Defibrillator Lumax 640 DR-T Lumax 640 DR-T Lumax 640 DR-T Lumax 640 DR-T e For single use only. Refer to Technical Manual for Instructions. e zz DF-1 RV DF-1 SVC IS-1/BI V:Pace/Sense IS-1/BI A:Pace/Sense nm nm Manufacturer:

Technical Report 3146179 Tach 35 (4120) SAR Analysis Rev. A Page 1 of 11 Letter Revisions Date Approval A Original 02-23-2006 BPS 1 Purpose The purpose of this report is to document the Specific Absorption Rate (SAR) computational analysis of the Biotronik Tach 35 (4120) Implantable Cardioverter Defibrillator (ICD). 2 Conclusion The Tach 35 ICD, 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 Tach 35 maximum worst-case, time-averaged SAR is 25.417 microW/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 Tach 35 SAR is 48 dB below the maximum allowable regulatory limit specified by the FCC. 3 Applicability This report is applicable to all Tach 35 ICD’s that use the same MICS RF transmitter circuitry and antenna structure noted in this report. 4 Document History Ver. A 02-23-2006 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. 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 Tach 35 (4120) 4120-00- A000723 N/A N/A SA Spectrum Analyzer Hewlett-Packard 8561E 3804A02248 09-15-2005 09-29-2006 SENSOR Power Meter Sensor Agilent 8481A MY41095529 05-23-2005 07-11-2006 PM Power Meter/Freq Counter Agilent 53147A US40470964 08-03-2005 08-03-2006 NET Network Analyzer Agilent 8753ES US39170321 05-25-2005 05-24-2006 CALKIT 3.5 mm Calibration Kit Agilent 85033D 3423A04725 11-14-2005 11-14-2008 CABLES Cables, 50 Ohm Coax with SMA connectors Pasternack Assorted N/A N/A N/A Technical Report 3146179 Tach 35 (4120) SAR Report Rev. A Page 2 of 11 IMP: The Tach 35 ICD evaluated in this test report. SA: A spectrum analyzer is used to monitor the RF signal emissions. SENSOR: Power meter RF sensor. PM: A power meter is used measure the system RF power levels. NET: A network analyzer used to measure impedance at RF frequencies CALKIT: Open/Short/Load calibration standards to calibrate the network analyzer. CABLES: 50
double-shielded cables with SMA connectors. 7.1 Photograph of the Tach 35 ICD Figure 7.1.1 shows a photograph of a Biotronik Tach 35 ICD. The loop antenna is embedded in the epoxy header. Figure 7.1.1 Photograph of a Tach 35 Implantable Cardioverter Defibrillator (ICD). 8 Tach 35 Measurement Results 8.1 Measurements for SAR Analysis: Transmitter Power: RF output power (Max): -3.39 dBm at 403.65 MHz, V CC = 3.0 Volts Measurement of Transmitter Output Impedance: The Tach 35 transmitter’s output impedance was measured using a calibrated RF network analyzer. The results of the measurement are shown in Figure 8.1.1 below. Technical Report 3146179 Tach 35 (4120) SAR Report Rev. A Page 3 of 11 Figure 8.1.1 Tach 35 transmitter output impedance. 9 Tach 35 Specific Absorption Rate (SAR) Analysis Biotronik Implantable Cardioverter Defibrillators (ICDs) 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 Tach 35 ICD. 9.1 Method of SAR Analysis The computational software used for this FDTD analysis was Remcom XFDTD Version 6.3.7.13. This software was used to convert a Biotronik 3-dimensional CAD engineering model of the ICD to a rectangular-grid FDTD computational space. A maximum uniform cell size of 0.3 mm was used in the SAR analysis. This allowed detailed modeling of the loop antenna structure in the ICD header. As the cell size is very small, it is not practical to include a model of the upper torso with the ICD. Previous experience using FDTD modeling methods has shown that the region of maximum SAR is concentrated very near the antenna structure. Thus the computational model used in this study was restricted to 2 cm of muscle tissue surrounding the ICD. As such, the computational space included in the analysis encompasses approximately 33 million cells. The region beyond the computational space was modeled with Liao-type perfectly absorbing material. Figure 9.1.1 below shows a 3D view of the SAR computational space, and the loop antenna in the Tach 35 ICD header can be clearly identified. The computational space used was 10.6 x 9.7 x 5.5 cm 3 , or approximately 565 cm 3 . This volume is more than sufficient for computing 1gram average SAR levels as required by the FCC. Technical Report 3146179 Tach 35 (4120) SAR Report Rev. A Page 4 of 11 Figure 9.1.1 3D view of the Tach 35 ICD 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 source power and impedance used to drive the antenna wer…

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Eurofins Product Service GmbH Storkower Str. 38c, 15526 Reichenwalde, Phone +49-33631-888 0 Germany Fax +49-33631-888 660 EUROFINS PRODUCT SERVICE GMBH Testing Cert #1983.01 TEST- REPORT Compliance Test Report FCC PART 15 SUBPART C IC RSS 310 ISSUE 3 Implantable Cardioverter Defibrillator FCC ID: QRILUMAXT50 IC : 4708A-LUMAXT50 Tach50 Substrate 4140 T EST REPORT NUMBER: G0M21101-4127-C-1 Test Report No.: G0M21101-4127-C-1 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany TABLE OF CONTENTS 1 General Information 3 1.1 Notes 3 1.2 Testing laboratory 4 1.3 Details of approval holder 5 1.4 Application details 5 1.5 Test item 5 1.6 Test standards 6 1.7 Additional information 6 1.8 Acronyms and abbreviations 7 2 Technical test 8 2.1 Summary of test results 8 2.2 Test environment 8 2.3 Test equipment utilized 9 2.4 Simulated human body 9 2.5 Test results 10 3 Transmitter parameters 11 3.1 Occupied Bandwidth 11 3.2 Transmitter spurious emissions 12 Annex A Photos 14 Annex B Occupied bandwidth 18 Annex C Transmitter radiated spurious emissions 19 Page 2 of 23 Page 3 of 23 Test Report No.: G0M21101-4127-C-1 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany 1.2 Testing laboratory EUROFINS PRODUCT SERVICE GMBH Storkower Strasse 38c D-15526 Reichenwalde b. Berlin Germany Telefon : +49 33631 888 00 Telefax : +49 33631 888 660 DAR ACCREDITED TESTING LABORATORY DAR-R EGISTRATION NUMBER: DAT-P-268/08 R ECOGNIZED NOTIFIED BODY EMC R EGISTRATION NUMBER: BNetzA-bS EMV-07/61 R ECOGNIZED NOTIFIED BODY R&TTE R EGISTRATION NUMBER: BNetzA-bS-02/51-53 FCC FILED TEST LABORATORY R EG.-NO. 96970 A2LA ACCREDITED TESTING LABORATORY C ERTIFICATE NO. 1983.01 B LUETOOTH QUALIFICATION TEST FACILITY (BQTF) A CCREDITED BY BLUETOOTH QUALIFICATION REVIEW BOARD I NDUSTRY CANADA FILED TEST LABORATORY R EG. NO. IC 3470 Test location, where different: Name : ./. Street : ./. Town : ./. Country : ./. Telephone : ./. Fax : ./. Page 4 of 23 Test Report No.: G0M21101-4127-C-1 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany 1.3 Details of approval holder Name : BIOTRONIK SE & Co. KG Street : Woermannkehre 1 Town : 12359 Berlin Country : Germany Telephone : 030/68905-1213 Fax : 030/68905-5409 Contact : Herr Gunnar Börsch Telephone : 030/68905-1213 1.4 Application details Date of receipt of application : 24.01.2011 Date of receipt of test item : 24.01.2011 Date of test : 24.01.2011 1.5 Test item Description of test item : Implantable Cardioverter Defibrillator Type identification : Tach50 Substrate 4140 Tested model : Lumax 740 HF-T Serial number : 60498675 Hardware version : Substrate 4140 Rev.: 1C Version 12 Software version : ROM: 2.2 / RAM: 1.0 Technical data Frequency range : 32kHz Tested frequencies : F 1 32kHz Antenna : non-removable connected to device Power supply : 3VDC (Lithium-Battery) Modulation : OOK Transmitter type : End product Page 5 of 23 Test Report No.: G0M21101-4127-C-1 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Manufacturer: (if applicable) Name : BIOTRONIK SE & Co. KG Street : Woermannkehre 1 Town : 12359 Berlin Country : Germany 1.6 Test standards Technical standard : FCC PART 15 SUBPART C § 15.201 / 15.209 IC RSS 310 ISSUE 3 / RSS-Gen ISSUE 3 1.7 Additional information In agreement with the customer testing was performed with a Lumax 740 HF-T as a representative for the Lumax 6XX and Lumax 7XX model families. The approval holder gives the following declarations about the two families: Variants: Lumax 600/640/700/740 VR-T/ VR-T DX/DR-T/HF-T The Lumax 6XX and the Lumax 7XX are two model families. Both families use the Tach50 Substrate 4140 electronic module and are therefore identical in hardware. That means that there are also no differences with respect to the RF-part between both families. The transmitter/receiver parts of all models of both families are identical to the tested model. The two families only differ in firmware. The Lumax 7XX family offers additional clinical therapy functions. Each family offers a 30 joule and a 40 joule model. The joule value is represented by the two XX in the model name; 00 = 30 joule, 40 = 40 joule. Additionally each family offers the VR-T, DR-T and HF-T variants. The VR-T variant denotes a single chamber header model, the DR-T a dual chamber header model and the HF-T a triple chamber header model. For VR-T variants (Lumax 6XX and Lumax 7XX) a special DX configuration exists that offers addi- tional diagnostics but uses identical electronic module and antenna. As described all model variations does not affect the rf-section of the device and for this reason the results given in this test report are supposed to be valid for all the described variations of the two de- noted model families. Page 6 of 23 Test Report No.: G0M21101-4127-C-1 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany 1.8 Acronyms and abbreviations EUT : Equipment under Test TX : Transmission RX : Reception RBW : Measurement Resolution Bandwidth Pol : Measurement Polarization T nom : Nominal Temperature T min : Minimum Temperature T max : Maximum Temperature V nom : Nominal Supply Voltage V min : Minimum Supply Voltage V max : Maximum Supply Voltage VDC : DC voltage N/A : Not applicable Page 7 of 23 Test Report No.: G0M21101-4127-C-1 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany 2 Technical test 2.1 Summary of test results No deviations from the technical specification(s) were ascertained in the course : of the tests performed. or The deviations as specified in 2.4 were ascertained in the course of the tests … performed. 2.2 Test environment Temperature : 22 ... 26°C Relative humidity content : 20 ... 75% Air pressure : 86 ... 103kPa Extreme conditions parameters: V nom : 3VDC T nom : 25°C Page 8 of 23 Test Report No.: G0M21101-4127-C-1 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany 2.3 T…

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Eurofins Product Service GmbH Storkower Str. 38c, 15526 Reichenwalde, Phone +49-33631-888 0 Germany Fax +49-33631-888 660 EUROFINS PRODUCT SERVICE GMBH Testing Cert #1983.01 RADIO TEST- REPORT Compliance Test Report Medical Device Radiocommunication Service (MedRadio) FCC 47 CFR Part 95E & 95I & 15B RSS 243 Issue 3 & RSS Gen Issue 3 Implantable Cardioverter Defibrillator Tach50 Substrate 4140 FCC ID: QRILUMAXT50 IC: 4708A-LUMAXT50 TEST REPORT NUMBER: G0M21101-4127-C-3 Test Report No.: G0M21101-4127-C-3 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany TABLE OF CONTENTS 1 General Information 3 1.1 Notes 3 1.2 Testing laboratory 4 1.3 Details of approval holder 5 1.4 Application details 5 1.5 Test item 5 1.6 Test standards 6 1.7 Additional information 6 1.8 Acronyms and Abbreviations 7 2 Technical test 8 2.1 Summary of test results 8 2.2 Test environment 8 2.3 Test equipment utilized 9 2.4 Simulated human body 9 2.5 Sample emission level calculation 10 2.6 Test results 11 3 Transmitter parameters 12 3.1 Occupied Bandwidth 12 3.2 Frequency stability 13 3.3 Emission Bandwidth 15 3.4 Equivalent isotropic radiated power 16 3.5 Transmitter radiated spurious emissions 17 4 Receiver parameters 20 4.1 Receiver spurious emissions 20 Annex A Photos 22 Annex B Occupied Bandwidth 26 Annex C Emission bandwidth 27 Annex D Effective radiated power 28 Annex E Transmitter spurious emissions 31 Annex F Receiver/Unintentional spurious emissions 52 Page 2 of 58 Page 3 of 58 Test Report No.: G0M21101-4127-C-3 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany 1.2 Testing laboratory EUROFINS PRODUCT SERVICE GMBH Storkower Strasse 38c D-15526 Reichenwalde b. Berlin Germany Telefon : +49 33631 888 00 Telefax : +49 33631 888 660 DAR ACCREDITED TESTING LABORATORY DAR-R EGISTRATION NUMBER: DAT-P-268/08 R ECOGNIZED NOTIFIED BODY EMC R EGISTRATION NUMBER: BNetzA-bS EMV-07/61 R ECOGNIZED NOTIFIED BODY R&TTE R EGISTRATION NUMBER: BNetzA-bS-02/51-53 FCC FILED TEST LABORATORY R EG.-NO. 96970 A2LA ACCREDITED TESTING LABORATORY C ERTIFICATE NO. 1983.01 B LUETOOTH QUALIFICATION TEST FACILITY (BQTF) A CCREDITED BY BLUETOOTH QUALIFICATION REVIEW BOARD I NDUSTRY CANADA FILED TEST LABORATORY R EG. NO. IC 3470 Test location, where different: Name : ./. Street : ./. Town : ./. Country : ./. Telephone : ./. Fax : ./. Page 4 of 58 Test Report No.: G0M21101-4127-C-3 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany 1.3 Details of approval holder Name : BIOTRONIK SE & Co. KG Street : Woermannkehre 1 Town : 12359 Berlin Country : Germany Telephone : 030/68905-1213 Fax : 030/68905-5409 Contact : Herr Gunnar Börsch Telephone : 030/68905-1213 1.4 Application details Date of receipt of application : 24.01.2011 Date of receipt of test item : 24.01.2011 Date of test : 24. – 26.01.2011 1.5 Test item Description of test item : Implantable Cardioverter Defibrillator Type identification : Tach50 Substrate 4140 Tested model : Lumax 740 HF-T Serial number : 60498675 Hardware Version : Substrate 4140 Rev.: 1C Version 12 Software Version : ROM: 2.2 / RAM: 1.0 Equipment type : Medica…

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