SAR exemption analysis version E

FCC ID: YSGVR1240

RF Exposure Info

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FCCID_2782225

FCC SAR report analysis for SORIN Platinium Implantable Medical Devices Reference: 131328—664446—AR—SAR Version: E Status: Approved Date: 06/0ct/2015 Customer: SORIN CRM Parc d‘Affaires NOVEO 4 avenue Réaumur 92143 Clamart cedex Products: SORIN Platinium cardioverter defibrillator Author: Zorica COROLLEUR 4 Technical Manager:. Marc CANCOUET P § C_'] , ‘T)s (')R & 50 D nrdelemrre HaF INDUSTRIES D *) S.A.S au capital de 15.7 4 RCS Nanterre B 408379 [{—e—ice] 33 avenue du Cénéradt Leclere F — 92266 EONTENAY AUX ROSES This document shall not be reproduced, except in full, without the written approval of the LCIE. This document contains results related only to the items tested. It does not imply the conformity of the whole production to the items tested. LCW §3 n du Genéni Leclere el— +33 1 10 95 60 60 Ssociel¢ Anony me Labormoire Centrsd BP 8 Fux +423 1 40 95 8h 36 au capriad de 15. 715 984 € des Iocusivies Eleciriques 922366 Ponteniv—aius Roses cedes conmeriélcte 1 RCS Nanterre B 108 463 171 tine sociéte de Bureau Yeritas branc www dore h

PUBLICATION HISTORY VERSION DATE AUTHOR MODIFICATION A 25-Aug-15 Z.COROLLEUR Creation of document B 15-Sep-15 Z.COROLLEUR Corrected FCC ID and Adding information on RF conducted output power C 23-Sep-15 Z.COROLLEUR Adding information about conducted power measurement D 29-Sep-15 Z.COROLLEUR Adding some internal photos E 06-Oct-15 Z.COROLLEUR Modification of document FCC SAR report analysis for SORIN Platinium Implantable Medical Devices 131328-664446-AR-SAR E 06/10/2015 Page 2/18

CONTENTS 1. INTRODUCTION ........................................................................................................................... 4 2. RELATED DOCUMENTS ............................................................................................................. 5 2.1. APPLICABLE STANDARDS ................................................................................................ 5 2.2. REFERENCE DOCUMENTS ................................................................................................ 5 3. SORIN PLATINIUM IMD ............................................................................................................... 6 3.1. GENERAL DESCRIPTION OF SYSTEM.............................................................................. 6 3.2. GENERAL DESCRIPTION OF IMPLANTABLE MEDICAL DEVICE .................................. 7 3.3. SCHEMATIC OF IMD ............................................................................................................ 9 3.4. ANTENNA CHARACTERISTIC OF IMD ............................................................................ 10 3.5. CHARACTERISTICS OF IMD............................................................................................. 11 4. TESTS RESULTS ....................................................................................................................... 12 4.1. RESULTS OF RADIATED OUTPUT POWER .................................................................... 12 4.2. RF CONDUCTED OUTPUT POWER ................................................................................. 12 4.2.1 RUNNING MODE ......................................................................................................... 12 4.2.2 TEST CONDITIONS ..................................................................................................... 12 4.2.3 TEST SETUP ............................................................................................................... 13 4.2.4 The access point for these RF measurements ........................................................ 14 4.2.5 TEST EQUIPMENT LIST ............................................................................................. 16 4.2.6 GRAPHICS & RESULTS ............................................................................................. 16 5. CONCLUSION ............................................................................................................................ 18 FCC SAR report analysis for SORIN Platinium Implantable Medical Devices 131328-664446-AR-SAR E 06/10/2015 Page 3/18

1. INTRODUCTION This document presents the results of tests performed on 8 SORIN PLATINIUM Implantable Medical Devices (IMD) to prove that all models are excluded of SAR evaluation. The SORIN PLATINIUM Implantable Medical Devices (IMD) is Compliant according to FCC part 95I standards. Hereafter is the list of models name and FCC ID: Models FCC ID DR 1540 FCC ID YSGDR1540 VR 1240 FCC ID YSGVR1240 CRT-D 1741 FCC ID YSGCRTD1741 SonR CRT-D 1841 FCC ID YSGCRTDSOR1841 DR 1510 FCC ID YSGDR1510 VR 1210 FCC ID YSGVR1210 CRT-D 1711 FCC ID YSGCRTD1711 SonR CRT-D 1811 FCC ID YSGCRTDSOR1811 FCC SAR report analysis for SORIN Platinium Implantable Medical Devices 131328-664446-AR-SAR E 06/10/2015 Page 4/18

2. RELATED DOCUMENTS 2.1. APPLICABLE STANDARDS [A1] KDB 865664 D02 RF Exposure Compliance Reporting and Documentation Considerations [A2] 47 CFR Part95I Medical Device Radiocommunication Service (MedRadio) [A3] 47 CFR PART15 Radio frequency devices 2.2. REFERENCE DOCUMENTS [R1] 131328-664446E Radio Test report of DR 1540 [R2] 131328-664446F Radio Test report of VR 1240 [R3] 131328-664446G Radio Test report of CRT-D 1741 [R4] 131328-664446H Radio Test report of SonR CRT-D 1841 [R5] 131328-664445E Radio Test report of DR 510 [R6] 131328-664445F Radio Test report of VR 1210 [R7] 131328-664445G Radio Test report of CRT-D 1711 [R8] 131328-664445H Radio Test report of SonR CRT-D 1811 [R9] MISC2583B Tune up procedure FCC SAR report analysis for SORIN Platinium Implantable Medical Devices 131328-664446-AR-SAR E 06/10/2015 Page 5/18

3. SORIN PLATINIUM IMD 3.1. GENERAL DESCRIPTION OF SYSTEM The purpose of the paragraph is to provide a high-level description of the structure and operation of the following sub-systems of Sorin Remote Monitoring System: the Smartview Monitor and the Implantable Medical Device. The Smartview Monitor (SM) is intended to collect patient’s clinical data from an Implantable Medical Device (IMD) and transfer them to data management system (Back Office server). The IMD is implanted into the patient’s body. The Smartview Monitor is installed at patient home and is intended to collect data from the IMD remotely in absence of physician according to scheduled operation. The Implantable Medical Device uses two wireless RF bands:  ISM band (2.45 GHz) for communication initialization (implant wake-up) receiver only  MedRadio (402-405 MHz) band for data transfer Implantable Medical Device (IMD) and transfer them to data management system (Back Office server). FCC SAR report analysis for SORIN Platinium Implantable Medical Devices 131328-664446-AR-SAR E 06/10/2015 Page 6/18

3.2. GENERAL DESCRIPTION OF IMPLANTABLE MEDICAL DEVICE PLATINIUM IMD is declined in 8 models: Models DR 1540 VR 1240 CRT-D 1741 SonR CRT-D 1841 DR 1510 VR 1210 CRT-D 1711 SonR CRT-D 1811 All models are an implantable cardioverter defibrillator for the recognition and treatment of ventricular tachycardia and fibrillation, with ventricular resynchronization, in patients with spontaneous or inducible tachyarrhythmias. Each IMD is equipped with an accelerometer to allow adaptation of pacing to suit the patient’s activity, and provide high energy shocks (42 J) for enhanced safety, as well as automatic lead measurements to monitor system integrity. PLATINIUM IMD is protected against high-frequency signals emitted by cellular telephones. Device and lead connections: PLATINIUM CRT-D 1711 3*IS-1 bipolar (LV unipolar compatible), 2*DF-1 PLATINIUM CRT-D 1741 2*IS-1 bipolar (LV unipolar compatible), 1*DF4 PLATINIUM SonR CRT-D 1811 2*IS-1 bipolar (LV unipolar compatible), 2*DF-1, 1*SonR (IS-1bipolar compatible) PLATINIUM SonR CRT-D 1841 1*IS-1 bipolar (unipolar compatible), 1*DF4, 1*SonR (IS-1 bipolar compatible) PLATINIUM DR 1510 2*IS-1 bipolar, 2*DF-1 PLATINIUM DR 1540 1*IS-1 bipolar, 1*DF4 PLATINIUM VR 1210 1*IS-1 bipolar, 2*DF-1 PLATINIUM VR 1240 1*DF4 FCC SAR report analysis for SORIN Platinium Implantable Medical Devices 131328-664446-AR-SAR E 06/10/2015 Page 7/18

Implantable Implantable cardioverter Type Model FCC Number cardioverter defibrillator photos Leads connection defibrillator with cardiac resynchronization FCC ID DR 1510 X YSGDR1510 FCC ID CRT-D1711 YSGCRTD1711 X DF1 FCC ID VR 1210 YSGVR1210 X FCC ID SonR CRT-D YSGCRTDSOR181 x 1811 1 FCC ID DR 1540 YSGDR1540 X FCC ID DF4 CRT-D1741 X YSGCRTD1741 FCC ID VR 1240 x YSGVR1240 FCC SAR report analysis for SORIN Platinium Implantable Medical Devices 131328-664446-AR-SAR E 06/10/2015 Page 8/18

FCC ID SonR CRT-D YSGCRTDSOR184 X 1841 1 DF-1 refers to the international standard for defibrillation lead connectors (ISO 11318:2002). DF4 refers to the international standard for defibrillation lead connectors (ISO 27186:2010). 3.3. SCHEMATIC OF IMD All models are using the same architecture: Battery, Capacitor and RF hardware. The only difference is the dimension of antenna and the numbers of leads. FCC SAR report analysis for SORIN Platinium Implantable Medical Devices 131328-664446-AR-SAR E 06/10/2015 Page 9/18

3.4. ANTENNA CHARACTERISTIC OF IMD The RF antenna consists in a gold wire loop of 0.4 mm diameter. It is the same for the SonR CRT-D, the CRT-D, the DR and the VR header of the DF1 family. The dimensions of antennas are illustrated in the following figures. RF antenna of the DF1 SonR, Crtd, Dr and Vr headers RF antenna of the DF4 SonR, Crtd, Dr and Vr headers FCC SAR report analysis for SORIN Platinium Implantable Medical Devices 131328-664446-AR-SAR E 06/10/2015 Page 10/18

3.5. CHARACTERISTICS OF IMD  Software identification: -Software version: ROM V2  Equipment information: - Modulation: 2FSK - Transmit operating mode: Multiples antenna Single antenna - Number of transmit chains: 1 2 - Number of receiver chains: 1 2 - Antenna type: Integral External - Type of the equipment: Stand-alone equipment Plug-in radio device Combined equipment - Temperature range: Tmin: -20°C 0°C 25°C Tnom: 37°C Tmax: +35°C 55°C 45°C - Test source voltage: Vmin: 207V/50Hz 2.5Vdc Vnom: 230V/50Hz 2.62Vdc Vmax: 253V/50Hz 3.24Vdc - Type of power source: Battery (Lithium-Ion) Internal power supply External power supply Car Charger - Test sequence/test software used: - Duty Cycle: Continuous duty Intermittent duty Continuous operation - Equipment type: Representative production model Pre-production model Operating frequency range: Frequency Band (MHz) 2400MHz to 2483,5MHz 5150MHz to 5350MHz 5470MHz to 5725MHz 402MHz to 405MHz -Channel plan: Channel Frequency (MHz) Cmin: 0 402.15 1 402.45 2 402.75 3 403.05 4 403.35 Cnom:5 403.65 6 403.95 7 404.25 8 404.55 Cmax: 9 404.85 FCC SAR report analysis for SORIN Platinium Implantable Medical Devices 131328-664446-AR-SAR E 06/10/2015 Page 11/18

4. TESTS RESULTS 4.1. RESULTS OF RADIATED OUTPUT POWER Below are the measured Radiated EIRP Powers, for details please refer to EMC test report. Reference to test Max measured EIRP Limit Models FCC ID EIRP(µW) (µW) Report DR 1540 FCC ID YSGDR1540 131328-664446E 0,047 25 VR 1240 FCC ID YSGVR1240 131328-664446F 0,075 25 CRT-D 1741 FCC ID YSGCRTD1741 131328-664446G 0,047 25 SonR CRT-D 1841 FCC ID YSGCRTDSOR1841 131328-664446H 0,059 25 DR 1510 FCC ID YSGDR1510 131328-664445E 0,047 25 VR 1210 FCC ID YSGVR1210 131328-664445F 0,059 25 CRT-D 1711 FCC ID YSGCRTD1711 131328-664445G 0,076 25 SonR CRT-D 1811 FCC ID YSGCRTDSOR1811 131328-664445H 0,076 25 4.2. RF CONDUCTED OUTPUT POWER 4.2.1 RUNNING MODE The EUT is set in the following mode during tests: - Continued transmission with modulation on an assigned channel at the highest power 4.2.2 TEST CONDITIONS Test performed by : Mathieu CERISIER Date of test : 2015/07/31 Ambient temperature : 26 Relative humidity : 32% FCC SAR report analysis for SORIN Platinium Implantable Medical Devices 131328-664446-AR-SAR E 06/10/2015 Page 12/18

4.2.3 TEST SETUP - The Equipment under Test is installed: In the climatic chamber On a table In an anechoic chamber -Measurement is performed with a spectrum analyzer On the EUT 50 ohms conducted access With a test fixture -Spectrum analyzer setup detail: RBW: 1 MHz VBW: 3 MHz Detector type: peak Sweep time: 1.9µs The spectrum analyzer marker peak function is used to find the maximum RF conducted output power. Since all 8 models use the same RF circuit and have identical RF characteristics (such as output power, Tx frequencies and modulations…etc) the tests were performed directly on one identical representative RF circuits mounted on SORIN workbench (note: SORIN workbench is a special test fixture provided by SORIN for controlling the testing mode and access to the EUT RF port for SORIN Implantable Medical Devices series and as shown below in the picture) Photograph for RF conducted output power FCC SAR report analysis for SORIN Platinium Implantable Medical Devices 131328-664446-AR-SAR E 06/10/2015 Page 13/18

4.2.4 THE ACCESS POINT FOR THESE RF MEASUREMENTS All 8 models are using the same architecture: Battery, Capacitor and RF hardware. The only difference is the dimension of the antenna and the numbers of leads. The hardware components are soldered on flex PCB. The flex PCB is folded and integrated in the IMD. Therefore testing one representative RF circuit is enough to cover all 8 modules’ RF conducted characteristics. The flex PCB is folded and integrated in IMD. The access point for these RF measurements is illustrated above. FCC SAR report analysis for SORIN Platinium Implantable Medical Devices 131328-664446-AR-SAR E 06/10/2015 Page 14/18

The flex PCB is folded and integrated in IMD. Internal photo of EUT BOTTOM VIEW of Flex PCB TOP VIEW of Flex PCB Zoom on UFL connector FCC SAR report analysis for SORIN Platinium Implantable Medical Devices 131328-664446-AR-SAR E 06/10/2015 Page 15/18

HYBRID RF PART (BOTTOM VIEW) HYBRID RF PART (TOP VIEW) RF feedthrough connection RF feedthrough connection Above figures show RF feedthrough pads on PCB for antenna connection and all RF traces on the PCB were designed for standard 50 ohm system. For reliable RF measurements, SORIN has installed a UFL connector directly on the antenna contact point for us to verify the actual RF output power to the antenna. The above setup pictures also show that the measurement system uses 50 ohm coaxial cable for connecting the EUT to spectrum analyzer. Therefore, the load impedance seen by the EUT (Equipment Under Test) is at optimum 50 ohm for max power output and cable loss has been considered and added back to the reading. 4.2.5 TEST EQUIPMENT LIST DESCRIPTION MANUFACTURER MODEL N° LCIE Cal_Date Cal_Due EMI test receiver R&S ESR A2642023 03/2015 03/2016 Teledyne & MINI 920-0202-024 & RF cable & Attenuator A5329674 10/2014 10/2015 CIRCUITS FW-20+ 4.2.6 GRAPHICS & RESULTS Since all 8 models share the same RF circuit and have identical RF characteristics, the following conducted power measurement result is applicable to all 8 models. Tnom Cmin FCC SAR report analysis for SORIN Platinium Implantable Medical Devices 131328-664446-AR-SAR E 06/10/2015 Page 16/18

Tnom Cnom Tnom Cmax Temperature Tnom Voltage Vnom Channel Cmin Cnom Cmax RF conducted output power (dBm) -11,98 -11,59 -11,4 RF conducted output power (mW) 0,063 0,069 0,072 All measurements are recorded in test reports listed in 4.1. FCC SAR report analysis for SORIN Platinium Implantable Medical Devices 131328-664446-AR-SAR E 06/10/2015 Page 17/18

5. CONCLUSION Since the test results, as reported in the previous section, demonstrate that both conducted and EIRP power plus 0.5dB tuneup tolerance are less than 1 mW, we would like to request FCC to grant SAR test exemption to all 8 of these applications according to FCC KDB 447498 section 4.2.4, as reprinted below. Thank you. FCC: KDB 447498 section 4.2.4: 4.2.4. Transmitters implanted in the body of a user When the aggregate of the maximum power available at the antenna port and radiating structures of an implanted transmitter, under all operating circumstances, is ≤ 1.0 mW, SAR test exclusion may be applied. The maximum available output power requirement and worst case operating conditions must be supported by power measurement results and fully justified in a SAR analysis report, in lieu of the SAR measurement or numerical simulation, according to design and implementation requirements of the device. END OF DOCUMENT FCC SAR report analysis for SORIN Platinium Implantable Medical Devices 131328-664446-AR-SAR E 06/10/2015 Page 18/18


Document Created: 2015-10-07 09:06:24
Document Modified: 2015-10-07 09:06:24
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