Test report - SAR exemption analysis

FCC ID: YSGCRTD1744

Test Report

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FCCID_3089494

FCC SAR report analysis for Platinium IS4 Implantable Cardioverter Defibrillator Reference: 137359-676558-AR-SAR Version: B Status: Approved Date: 19/Jul/2016 Customer: SORIN CRM SAS Parc d'Affaires NOVEOS 4 avenue Réaumur 92140 Clamart Products: Platinium IS4 Implantable Cardioverter Defibrillator Author: Zorica COROLLEUR Technical Manager: Marc CANCOUET 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.

PUBLICATION HISTORY VERSION DATE AUTHOR MODIFICATION A 30-Jun-16 Z.COROLLEUR Creation of document B 19-Jul-16 Z.COROLLEUR Corrections after TCB review FCC SAR report analysis for Platinium IS4 Implantable Medical Devices 137359-676558-AR-SAR B 19/07/2016 Page 2/15

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 ............................................................................................................8 3.4. CHARACTERISTICS OF IMD ...............................................................................................8 4. TESTS RESULTS ........................................................................................................................10 4.1. RESULTS OF RADIATED OUTPUT POWER ....................................................................10 4.2. RF CONDUCTED OUTPUT POWER ..................................................................................10 4.2.1 RUNNING MODE ..........................................................................................................10 4.2.2 TEST CONDITIONS .....................................................................................................10 4.2.3 TEST SETUP ................................................................................................................10 4.2.4 The access point for these RF measurements ........................................................11 4.2.5 TEST EQUIPMENT LIST ..............................................................................................13 4.2.6 GRAPHICS & RESULTS ..............................................................................................13 5. CONCLUSION .............................................................................................................................15 FCC SAR report analysis for Platinium IS4 Implantable Medical Devices 137359-676558-AR-SAR B 19/07/2016 Page 3/15

1. INTRODUCTION This document presents the results of tests performed on two SORIN PLATINIUM Implantable Medical Devices (IMD) to prove that all models are excluded of SAR evaluation. The PLATINIUM IS4 Implantable Cardioverter Defibrillator is compliant according to FCC part 95I standards. Hereafter is the list of models name and FCC ID: Models FCC ID CRT-D 1744 FCC ID YSGCRTD1744 SonR CRT-D 1844 FCC ID YSGCRTDSOR1844 CRT-D 1744 SonR CRT-D 1844 FCC SAR report analysis for Platinium IS4 Implantable Medical Devices 137359-676558-AR-SAR B 19/07/2016 Page 4/15

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] 137359-676558B Radio Test report of PLATINIUM 4LV CRT-D 1744 [R2] 137359-676558E Radio Test report of PLATINIUM 4LV SonR CRT-D 1844 [R3] MISC3286A Tune up procedure FCC SAR report analysis for Platinium IS4 Implantable Medical Devices 137359-676558-AR-SAR B 19/07/2016 Page 5/15

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 Platinium IS4 Implantable Medical Devices 137359-676558-AR-SAR B 19/07/2016 Page 6/15

3.2. GENERAL DESCRIPTION OF IMPLANTABLE MEDICAL DEVICE PLATINIUM 4LV IMD is declined in 2 models: Models CRT-D 1744 SonR CRT-D 1844 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. Type Model FCC Number photos Leads connection CRT-D 1744 YSGCRTD1744 IS4 SonR CRT-D 1844 YSGCRTDSOR1844 FCC SAR report analysis for Platinium IS4 Implantable Medical Devices 137359-676558-AR-SAR B 19/07/2016 Page 7/15

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. 3.4. CHARACTERISTICS OF IMD  Software identification: -Software version: ROM V2Build 27  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 FCC SAR report analysis for Platinium IS4 Implantable Medical Devices 137359-676558-AR-SAR B 19/07/2016 Page 8/15

- 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 Platinium IS4 Implantable Medical Devices 137359-676558-AR-SAR B 19/07/2016 Page 9/15

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 CRT-D 1744 FCC ID YSGCRTD1744 137359-676558B 0,028 25 SonR CRT-D 1844 FCC ID YSGCRTDSOR1844 137359-676558E 0,035 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 : Stéphane PHOUDIAH Date of test : 2016/04/07 Ambient temperature : 22°C Relative humidity : 40% 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 FCC SAR report analysis for Platinium IS4 Implantable Medical Devices 137359-676558-AR-SAR B 19/07/2016 Page 10/15

The spectrum analyzer marker peak function is used to find the maximum RF conducted output power. Since all 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 4.2.4 THE ACCESS POINT FOR THESE RF MEASUREMENTS All two 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. FCC SAR report analysis for Platinium IS4 Implantable Medical Devices 137359-676558-AR-SAR B 19/07/2016 Page 11/15

The flex PCB is folded and integrated in IMD. The access point for these RF measurements is illustrated in internal photos exhibit. FCC SAR report analysis for Platinium IS4 Implantable Medical Devices 137359-676558-AR-SAR B 19/07/2016 Page 12/15

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 A2642010 2015/05 2016/05 Teledyne & MINI 920-0202-024 & RF cable & Attenuator A5329674 2015/10 2016/10 CIRCUITS FW-20+ 4.2.6 GRAPHICS & RESULTS Since all models share the same RF circuit and have identical RF characteristics, the following conducted power measurement result is applicable to all models. Tnom Cmin FCC SAR report analysis for Platinium IS4 Implantable Medical Devices 137359-676558-AR-SAR B 19/07/2016 Page 13/15

Tnom Cnom Tnom Cmax Temperature Tnom Voltage Vnom Channel Cmin Cnom Cmax RF conducted output power (dBm) -6.62 -6.33 -7.58 RF conducted output power (mW) 0.22 0.23 0.17 All measurements are recorded in test reports listed in 4.1. FCC SAR report analysis for Platinium IS4 Implantable Medical Devices 137359-676558-AR-SAR B 19/07/2016 Page 14/15

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 Platinium IS4 Implantable Medical Devices 137359-676558-AR-SAR B 19/07/2016 Page 15/15


Document Created: 2016-07-27 11:05:12
Document Modified: 2016-07-27 11:05:12
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