
Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.
U131A U131-2 VVED-DDDRV As-shipped parameters / Paramètres à l’expédition / Parameter bei Auslieferung / Valori da spedizione / Parámetros expedición (37°C, 500 X) : OFF 60 min -1 DDD Mode Mode Modus Modo Modo Rate response Asservissement Frequenzadaptation Frequenza variabile Adaptación de frecuencia OFF Basic rate Fréquence de base Basisfrequenz Frequenza di base Frecuencia basal Shocks and ATP Chocs et ATP Schocks und ATP Shock e ATP Choques y ATP U131-1 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Ventricular antitachycardia pacing Dual chamber arrhythmia detection DDDR and biventricular pacing DÉFIBRILLATEUR CARDIOVERTEUR IMPLANTABLE Stimulation antitachycardique ventriculaire Détection double chambre des arythmies Stimulation DDDR et biventriculaire IMPLANTIERBARER KARDIOVERTER-DEFIBRILLATOR Ventrikuläre antitachykarde Stimulation Zweikammer-Arrhythmie-Erkennung DDDR und bi-ventrikuläre Stimulation DEFIBRILLATORE CARDIOVERTER IMPIANTABILE Stimolazione antitachicardica ventricolare Detezione bicamerale delle aritmie Stimolazione DDDR e biventricolare DESFIBRILADOR CARDIOVERSOR IMPLANTABLE Estimulación antitaquicárdica ventricular Detección bicameral de las arritmias Estimulación DDDR y biventricular Manufactured in Italy by: Sorin Group Italia S.r.l. Via Crescentino s.n. 13040 Saluggia (VC) - ITALY CRT-D 174 DF- 4 LLHH IS-1 BI Unipolar compatible IS-1 BI (year-month-day) (year-month-day) FCC ID YSGCRTD174 IC: 10270A-CRTD174 CRT-D 174 CRT-D 174 REF REF SN SN Remote SN REF SN (year-month-day) SN (year-month-day) SN (year-month-day) SN (year-month-day) SN (year-month-day) SN (year-month-day) SN SN SN SN SN SN SN SN REF REF REF REF REF REF CRT-D 174 CRT-D 174 CRT-D 174 CRT-D 174 CRT-D 174 CRT-D 174 CRT-D 174 CRT-D 174 CRT-D 174 CRT-D 174 CRT-D 174 CRT-D 174 CRT-D 174 Contents : Defi brillator and screwdriver Contenu : Défi brillateur et tournevis Inhalt : Defi brillator und Schraubendreher Contenuto : Defi brillatore e cacciavite Contenido : Desfi brilador y destornillador
PULL TO OPEN U132-1 U132-2 VVED-DDDRV CRT-D 174 U132-3 U132A CRT-D 174 VVED-DDDRV CRT-D 174 VVED-DDDRV VVED-DDDRV CRT-D 174 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Ventricular antitachycardia pacing Dual chamber arrhythmia detection DDDR and biventricular pacing DÉFIBRILLATEUR CARDIOVERTEUR IMPLANTABLE Stimulation antitachycardique ventriculaire Détection double chambre des arythmies Stimulation DDDR et biventriculaire IMPLANTIERBARER KARDIOVERTER-DEFIBRILLATOR Ventrikuläre antitachykarde Stimulation Zweikammer-Arrhythmie-Erkennung DDDR und bi-ventrikuläre Stimulation DEFIBRILLATORE CARDIOVERTER IMPIANTABILE Stimolazione antitachicardica ventricolare Detezione bicamerale delle aritmie Stimolazione DDDR e biventricolare DESFIBRILADOR CARDIOVERSOR IMPLANTABLE Estimulación antitaquicárdica ventricular Detección bicameral de las arritmias Estimulación DDDR y biventricular *XXXX* *XXXX* As-shipped parameters / Paramètres à l’expédition / Parameter bei Auslieferung / Valori da spedizione / Parámetros expedición (37°C, 500 ) : Mode Mode Modus Modo Modo Basic rate Fréquence de base Basisfrequenz Frequenza di base Frecuencia basal 60 min -1 DDD Rate response Asservissement Frequenzadaptation Frequenza variabile Adaptación de frecuencia Shocks and ATP Chocs et ATP Schocks und ATP Shock e ATP Choques y ATP OFF OFF Handle with care / Manipuler avec précautions / Vorsichtig behandeln / Manipolare con cura / Manipular con precaución Contents : Defi brillator, screwdriver and product literature (CD-ROM) Contenu : Défi brillateur, tournevis et documentation (CD-ROM) Inhalt : Defi brillator, Schraubendreher und Produktdokumentation (CD-ROM) Contenuto : Defi brillatore, cacciavite e documentazione (CD-ROM) Contenido : Desfi brilador, destornillador y documentación (CD-ROM) DF- 4 LLHH IS-1 BI Unipolar compatible IS-1 BI DF- 4 LLHH IS-1 BIUnipolar compatible IS-1 BI DF- 4 LLHH IS-1 BIUnipolar compatible IS-1 BI Manufactured in Italy by: Sorin Group Italia S.r.l. Via Crescentino s.n. 13040 Saluggia (VC) - ITALY Date of manufacture (year-month-day) Sterilization lot number Serial number Use by (year-month-day) FCC ID YSGCRTD174 IC: 10270A-CRTD174 Sterilized using ethylene oxide High voltage CD-ROM  Consult instructions for use 0°C 50°C Temperature limitation Use by (year-month-day) Serial number Serial number Use by (year-month-day)
SYRF V2 DF4 CRT-D174 FCC ID: YSGCRTD174 – Internal photographs
OFFICIAL DOCUMENT Document Name / Nome documento / Nom du document MISC1582B FF00929C - DHF Page 1/16 This document contains information which Sorin Group deems CONFIDENTIAL and PROPRIETARY; therefore it shall not to be used, duplicated, or disclosed in whole or in part without the prior written consent of Sorin Group. Type of document / Tipo di documento / Type de document Technical Note Project Syndeli RF V2 DF4 Department: COE-IDS Original stored in: Clamart Department Internal Ref: Title: SYNDELI RF V2 DF4: CHANGES VALIDATION VERSUS PARADYM RF JPN RDY Filed in Intraprod on : By: Abstract: This document lists the tests already performed on PARADYM RF JPN RDY and evaluates if their results are eligible or not for SYNDELI RF V2 DF4. If needed, some additional tests will be made to finalize the qualification. Distribution of this document is limited to the following individuals (if not applicable left empty): Name Function Signature Date Prepared by E. Abhamon R&D Project leader June 10 th , 2013 Verified by C. de Jeso QA CT member Verified by G. Salaün RA CT member Approved by P. Barou CT Leader ELECTRONIC RELEASE CERTIFIED COMPLIANT TO THE ORIGINAL SIGNED AND APPROVED DOCUMENT OFFICIAL DOCUMENT Document Name / Nome documento / Nom du document MISC1582B FF00929C - DHF Page 2/16 This document contains information which Sorin Group deems CONFIDENTIAL and PROPRIETARY; therefore it shall not to be used, duplicated, or disclosed in whole or in part without the prior written consent of Sorin Group. HISTORY / STORIA / HISTORIQUE Rev. Change Reason for Change Release date A Original document in English New project SYRF V2 with DF4 headers Dec. 5th, 2012 B - Editorial correction of reference of document SYNDELI RF V2 DF4 Inductive telemetry performances - New revision of PLAN0694D and REP0776D - Removed rev. D of MISC0513 - Previously wrongly referenced MISC1633 instead of MISC1663 - Versioning update - SAR evaluation is fully covered by MISC1665A ELECTRONIC RELEASE CERTIFIED COMPLIANT TO THE ORIGINAL SIGNED AND APPROVED DOCUMENT OFFICIAL DOCUMENT Document Name / Nome documento / Nom du document MISC1582B FF00929C - DHF Page 3/16 This document contains information which Sorin Group deems CONFIDENTIAL and PROPRIETARY; therefore it shall not to be used, duplicated, or disclosed in whole or in part without the prior written consent of Sorin Group. TABLE OF CONTENT / INDICE / TABLE DES MATIERES 1 Scope ............................................................................................................................................ 4 2 Documents of precedence............................................................................................................ 4 3 Design changes, Background ...................................................................................................... 5 3.1 Mechanics .............................................................................................................................. 5 3.2 Electronics .............................................................................................................................. 5 3.3 Embedded Software ................................................................................................................ 5 4 Syndeli RF V2 DF4 devices identification versus Paradym RF JPN Rdy ones ........................ 5 5 Device definition mapping .......................................................................................................... 6 6 Device under test selection .......................................................................................................... 7 7 Syndeli RF V2 DF4 V&V versus Paradym RF JPN Rdy V&V source ..................................... 8 8 Syndeli RF V2 DF4 V&V, DHF References mapping ............................................................. 13 ELECTRONIC RELEASE CERTIFIED COMPLIANT TO THE ORIGINAL SIGNED AND APPROVED DOCUMENT OFFICIAL DOCUMENT Document Name / Nome documento / Nom du document MISC1582B FF00929C - DHF Page 4/16 This document contains information which Sorin Group deems CONFIDENTIAL and PROPRIETARY; therefore it shall not to be used, duplicated, or disclosed in whole or in part without the prior written consent of Sorin Group. 1 Scope This document lists, based on design changes (DF4 new headers), the complete Syndeli RF V2 DF4 V&V that has to be done according to the following three kind of methods : x Redo tests already performed for PARADYM RF JPN RDY V&V, x Apply PARADYM RF JPN RDY exisiting plans & reports with justifications, x Perform new tests not required for PARADYM RF JPN RDY platform and PARADYM RF existing DHF basis. 2 Documents of precedence Design Verifications & Validations definitions have been defined through the assessment phases concluded by the following top level Syndeli RF V2 Specifications Review & new parts Design Reviews: x REQ0964 Paradym RF, Paradym V2 & Tri-V, Syndeli RF V2 - Functional Specifications x REQ0947 Syndeli RF & Syndeli RF V2 DF4 models and ZL modules serial number encoding x CR00245 DF4 Headers Design Review meeting minutes x CR00304 Syndeli RF V2 DF4 Specification Review meeting minutes x MISC1134 Syndeli RF JPN RDY : Changes validation versus Syndeli RF ELECTRONIC RELEASE CERTIFIED COMPLIANT TO THE ORIGINAL SIGNED AND APPROVED DOCUMENT OFFICIAL DOCUMENT Document Name / Nome documento / Nom du document MISC1582B FF00929C - DHF Page 5/16 This document contains information which Sorin Group deems CONFIDENTIAL and PROPRIETARY; therefore it shall not to be used, duplicated, or disclosed in whole or in part without the prior written consent of Sorin Group. 3 Design changes, Background 3.1 Mechanics The table below describes all the design changes introduced on those header parts potentially inducing electronics or system performances impacts: Headers Change Reason for change DF4 headers Vs DF1 headers Moved to 1 DF-4 cavity from previous 2 DF-1 cavities & 1 IS-1 cavity Respond to market n…
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MORE DETAILS for question 7:
INTENSIA CRT-D 174 The document titled ‘cover letter FCC for question 8’ indicates that model CRT-D 174 and CRT-D 9750 are similar devices, with the major difference being the radiated header. The 2 devices share the same electronics, battery, shock capacitors, main and RF feedthroughs and titanium cases. The only differences are the wire routing inside the headers, as the connector blocks do not have the same location in the Tecothane moulded headers, and the radiated headers and the silicone caps glued on the headers. The aim of the new header is to propose DF-4 connection to the physicians and the patients, which allow lowering the connection time of the leads during implantation (3 ports vs 5). Paradym RF CRT-D 9750 has 5 ports: Atrium: IS-1, Right ventricle: IS-1, DF-1, Left ventricle: IS-1. INTENSIA CRT-D 174 has 3 ports: Atrium: IS-1, Right ventricle: DF-4, Left ventricle: IS-1. The DF-1 RF antenna plane is flat and located in the middle of the radiated header (highlighted in green in below 3D pictures), as the 5 lead cavities have roughly the same diameters 3,7 mm and located both sides of the 11,5 mm width header. Paradym RF CRT-D 9750 (header with IS-1 & DF-1 lead cavities): The DF-4 cavity diameter being bigger (6,35 mm), we had to route RF antenna wire around the DF-4 cavity. Please refer to the 2 pictures below (RF antenna highlighted in green in below 3D pictures). Intensia CRT-D 174 (header with IS-1 & DF-4 lead cavities):
FF00929A Document reference MISC444B Dept. internal ref. - Page 1/16 This document contains information which Sorin Group deems CONFIDENTIAL and PROPRIETARY; therefore it shall not to be used, duplicated, or disclosed in whole or in part without the prior written consent of Sorin Group. OFFICIAL DOCUMENT Document type: Technical Note Document reference MISC444B Dept. internal ref. - Project: RMS Department: R&D Reserved to the assistant filing the document Filed in IntraELA by : on Original in: Clamart Title: Smartview Monitor and IMD System Description Abstract: High-level description of the structure and operation of the Smartview Monitor and associated Implantable Medical Device Name Function Signature Date Prepared by Fabio Belletti SM project leader Nov. 1 st , 2011 Reviewed by Philippe Barou IMD project leader Reviewed by Thierry Scordilis RF Function Leader Reviewed by Cecile de Jeso SM & Syndeli RF RA Engineer Reviewed by Approved by Daniel Kroiss RF team Manager FF00929A Document reference MISC444B Dept. internal ref. - Page 2/16 This document contains information which Sorin Group deems CONFIDENTIAL and PROPRIETARY; therefore it shall not to be used, duplicated, or disclosed in whole or in part without the prior written consent of Sorin Group. OFFICIAL DOCUMENT REVISION HISTORY Rev. Sect. Change Author Release date A 1 Initial release Fabio Belletti 09-Mar-2009 2 Functional description added Fabio Belletti 25-Feb-2010 3 IMD description add-on Philippe Barou 01-Mar-2010 4 SM software test scheme Fabio Belletti 05-Mar-2010 5 Transfer in FF929 format Cecile de Jeso 18-Mar-2010 6 New ICD image, approver Fabio Belletti 19-Mar-2010 B § 1.3.3 Block Diagram removed (FCC req) Everywhere: Home Monitor (or SM) updated to Smartview Monitor (or SM) Everywhere: MICS updated to MedRadio Georges Wanderstok FF00929A Document reference MISC444B Dept. internal ref. - Page 3/16 This document contains information which Sorin Group deems CONFIDENTIAL and PROPRIETARY; therefore it shall not to be used, duplicated, or disclosed in whole or in part without the prior written consent of Sorin Group. OFFICIAL DOCUMENT TABLE OF CONTENT 1. Introduction ............................................................................................................... 4 1.1. Purpose ................................................................................................................. 4 1.2. Acronyms ............................................................................................................. 4 1.3. System description ............................................................................................... 5 1.3.1. SM Operating modes .................................................................................... 5 1.3.2. IMD Operating modes .................................................................................. 5 1.3.3. IMD Hardware .............................................................................................. 6 2. Smartview Monitor Functional Descritption ......................................................... 6 2.1. Smartview Monitor Operation ............................................................................. 6 2.2. Smartview Monitor Main Features ...................................................................... 7 2.2.1. Functional Description of the Smartview Monitor software ........................ 7 2.2.2. User Interface ................................................................................................ 9 2.2.3. Normal Operation ......................................................................................... 9 2.2.4. On-Demand Follow-Up ................................................................................ 9 2.2.5. Alerts ........................................................................................................... 10 2.2.6. SM-BO communication .............................................................................. 10 2.2.7. SM-IMD communication ............................................................................ 11 2.2.8. Self test ........................................................................................................ 11 2.2.9. Upgrades ..................................................................................................... 12 3. Smartview Monitor Test ......................................................................................... 12 3.1. Smartview Monitor TEST Utilities .................................................................... 13 3.2. Smartview Monitor Basic operation .................................................................. 13 3.3. FailureS and recovery ......................................................................................... 15 3.3.1. Admitted failures ........................................................................................ 15 3.3.2. Not Admitted failures ................................................................................. 15 3.3.3. Faults Recovery .......................................................................................... 15 4. IMD Test .................................................................................................................. 16 FF00929A Document reference MISC444B Dept. internal ref. - Page 4/16 This document contains information which Sorin Group deems CONFIDENTIAL and PROPRIETARY; therefore it shall not to be used, duplicated, or disclosed in whole or in part without the prior written consent of Sorin Group. OFFICIAL DOCUMENT 1. INTRODUCTION 1.1. PURPOSE The purpose of the present document 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 ma…
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OFFICIAL DOCUMENT Document Name / Nome documento / Nom du document MISC1665A FF00929B - DHF Page 1/26 This document contains information which Sorin Group deems CONFIDENTIAL and PROPRIETARY; therefore it shall not to be used, duplicated, or disclosed in whole or in part without the prior written consent of Sorin Group. Type of document / Tipo di documento / Type de document Technical Note Project SyndeliRF V2 Department: ASIC Original stored in: Meylan Department Internal Ref: Title: SAR SIMULATION REPORT Filed in Intraprod on : By: Abstract: This document deals with the SAR simulations results performed on the 4 different headers of SyndeliRF V2 ICDs (CRTD SonR / CRTD / DR / VR). Name Function Signature Date Prepared by H. Guidetti RF System Engineer Dec. 20th, 2012 Verified by T. Scordilis RF team Leader Verified by C.de Jeso RA Project Leader Verified by O.Varomme QA Project Leader Approved by E.Abhamon R&D Project leader ELECTRONIC RELEASE CERTIFIED COMPLIANT TO THE ORIGINAL SIGNED AND APPROVED DOCUMENT OFFICIAL DOCUMENT Document Name / Nome documento / Nom du document MISC1665A FF00929B - DHF Page 2/26 This document contains information which Sorin Group deems CONFIDENTIAL and PROPRIETARY; therefore it shall not to be used, duplicated, or disclosed in whole or in part without the prior written consent of Sorin Group. HISTORY / STORIA / HISTORIQUE Rev. Change Reason for Change Release date A / Document creation Dec. 20th, 2012 ELECTRONIC RELEASE CERTIFIED COMPLIANT TO THE ORIGINAL SIGNED AND APPROVED DOCUMENT OFFICIAL DOCUMENT Document Name / Nome documento / Nom du document MISC1665A FF00929B - DHF Page 3/26 This document contains information which Sorin Group deems CONFIDENTIAL and PROPRIETARY; therefore it shall not to be used, duplicated, or disclosed in whole or in part without the prior written consent of Sorin Group. TABLE OF CONTENT / INDICE / TABLE DES MATIERES 1. INTRODUCTION ........................................................................................................................ 5 2. ABREVIATIONS ......................................................................................................................... 5 3. SAR DEFINITION ....................................................................................................................... 6 4. REFERENCE STANDARDS ....................................................................................................... 6 5. SAR LIMITS ................................................................................................................................ 7 5.1. GENERAL : ICNIRP LEVELS ................................................................................................ 7 5.2. EUROPE REGION .................................................................................................................. 7 5.3. USA REGION ......................................................................................................................... 7 6. METHODS FOR SAR CALCULATION .................................................................................... 8 7. CST MWS SAR CALCULATION METHOD ............................................................................ 9 8. COMPUTATIONAL RESOURCES ........................................................................................... 9 9. GENERAL COMMON SIMULATION CONDITIONS ............................................................ 9 9.1. LEAD CONFIGURATION ...................................................................................................... 9 9.2. TISSUE PROPERTIES .......................................................................................................... 10 9.3. SIMULATION VOLUME ..................................................................................................... 11 9.4. BOUNDARY CONDITIONS ................................................................................................ 11 9.5. METAL properties ................................................................................................................. 11 9.6. EXCITATION PORT ............................................................................................................ 12 9.7. INPUT POWER ..................................................................................................................... 13 9.8. CHOICE OF FREQUENCY .................................................................................................. 13 9.9. RF ANTENNA ...................................................................................................................... 13 9.10. SAR parameters .................................................................................................................. 14 9.11. MESH DENSITY ............................................................................................................... 16 9.12. CONVERGENCE CRITERIA ............................................................................................ 17 10. CRT-D SonR ICD SIMULATION .......................................................................................... 18 10.1. DEVICE AND SIMULATION VOLUME ......................................................................... 18 10.2. SAR SIMULATION RESULTS ......................................................................................... 18 10.2.1. EUROPE : 10G CUBE TISSUE .................................................................................. 18 10.2.2. USA : 1G CUBE TISSUE ........................................................................................... 18 10.3. CONCLUSIONS ................................................................................................................ 19 11. CRT-D ICD SIMULATION .................................................................................................... 20 11.1. DEVICE AND SIMULATION VOLUME ........................................................…
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TEST REPORT N° 119405-638393G-Cr-2014-01-20 Page 2 SUMMARY 1. TEST PROGRAM ............................................................................................................................... 3 2. EQUIPMENT DESCRIPTION .............................................................................................................. 5 3. FREQUENCY ERROR & FREQUENCY STABILITY ........................................................................... 8 4. EFFECTIVE RADIATED POWER, MAXIMUM TRANSMITTER POWER & ANTENNA POWER ........ 9 5. EMISSION BANDWIDTH & OCCUPIED BANDWIDTH ..................................................................... 11 6. SPURIOUS EMISSIONS OF TRANSMITTER & TOLERANCE OF UNWANTED EMISSION INTENSITY ................................................................................................................................................... 12 7. UNWANTED RADIATION ................................................................................................................. 17 8. RECEIVER SPURIOUS RADIATION & SECONDARY RADIATED EMISSION ................................ 19 9. RADIATION EMISSIONS .................................................................................................................. 22 10. TEST EQUIPMENT LIST .................................................................................................................. 24 11. UNCERTAINTIES CHART ................................................................................................................ 25 12. ANNEX 1 (GRAPHS) ........................................................................................................................ 26 13. ANNEX 2 (FLUID DATA SHEET MSL 450) ....................................................................................... 45 TEST REPORT N° 119405-638393G-Cr-2014-01-20 Page 3 1. TEST PROGRAM References Standards : ETSI EN 301 839-1 V1.3.1 ETSI EN 301 839-2 V1.2.1 ERC Recommendation 70-03 FCC RULES PART 95I FCC RULES PART 15 FCC RULES PART 2 IC RADIO STANDARDS RSS-243 Specified low-power radio equipment (Item 8 of Article 2 Paragraph 1 of Certification Ordinance) Transmitter requirement: Clause (ETSI EN 301 839–1) Clause (FCC PART 95I) Clause (RSS 243) Clause (Specified low-power radio equipment (Item 8 of Article 2 Paragraph 1 of Certification Ordinance)) Test Description TEST RESULT - Comments EN § 8.1 – Frequency error FCC § 95.627 (e) – Frequency stability FCC § 2.1055 – Measurements required: Frequency stability RSS § 3.3 – Frequency stability Specified low-power radio equipment (Item 8 of Article 2 Paragraph 1 of Certification Ordinance) –Tolerance of frequency PASS (Remark 1) PASS (Remark 1) PASS (Remark 1) PASS (Remark 1) PASS (Remark 1) EN § 8.3 – Effective radiated power of the fundamental emission FCC § 95.639 (f) – Maximum transmitter power FCC § 2.1046 – Measurements required: RF power output RSS § 5.4 – Maximum transmitter power Specified low-power radio equipment (Item 8 of Article 2 Paragraph 1 of Certification Ordinance) – Antenna gain PASS PASS PASS PASS PASS EN § 8.2 – Emission bandwidth FCC § 95.633 (e) – Emission bandwidth FCC § 2.1049 – Measurements required: Occupied bandwidth RSS § 3.2 – Occupied bandwidth Specified low-power radio equipment (Item 8 of Article 2 Paragraph 1 of Certification Ordinance) – Tolerance of occupied bandwidth PASS (Remark 1) PASS (Remark 1) PASS (Remark 1) PASS (Remark 1) PASS (Remark 1) EN § 8.5 – Frequency stability under low voltage conditions N/A (EUT hermetically sealed: See last paragraph in clause 5.2.2 of ETSI EN 301 839-1 V1.3.1) EN § 8.4 – Spurious emissions of transmitter Specified low-power radio equipment (Item 8 of Article 2 Paragraph 1 of Certification Ordinance) – Tolerance of unwanted emission intensity PASS PASS FCC § 95.635 (d) – Unwanted radiation FCC § 2.1053 – Measurements required: Field strength of spurious radiation RSS § 3.4 – Unwanted radiation Specified low-power radio equipment (Item 8 of Article 2 Paragraph 1 of Certification Ordinance) – Limit of secondary radiated emission PASS PASS PASS PASS 15.207 – Conducted emission N/A (Equipment powered by battery) FCC § 2.1047 – Measurements required: Modulation characteristics PASS ( please refer to §2.1 Equipment information p.5) FCC § 2.1057 – Frequency spectrum to be investigated PASS (see §2.1 Equipment information p.5) TEST REPORT N° 119405-638393G-Cr-2014-01-20 Page 4 Receiver requirement: Clause (ETSI EN 301 839–1) Clause (FCC PART 15) (only for 400MHz receiver) Clause (FCC PART 95I) Clause (RSS 243-243) Test Description TEST RESULT - Comments EN § 9.1 – Spurious radiation of receivers FCC § 2.1053 – Measurements required: Field strength of spurious radiation PASS PASS FCC § 15.109 – Radiated emissions RSS § 3.5 – Radiated emissions PASS PASS EN § 10.1 – Monitoring system threshold power level FCC § 95.627 (a)(3) – Monitoring system threshold power level RSS § 5.7.1 – Monitoring system threshold power level N/A N/A N/A EN § 10.2 – Monitoring system bandwidth FCC § 95.627 (a)(1) – Monitoring system bandwidth RSS § 5.7.2 – Monitoring system bandwidth N/A N/A N/A EN § 10.3.1.1 & 10.3.3.1 – Scan cycle time FCC § 95.627 (a)(2) – Scan cycle time RSS § 5.7.3 – Scan cycle time N/A N/A N/A EN § 10.3.1.2 & 10.3.3.2 – Minimum channel monitoring period FCC § 95.627 (a)(2) – Minimum channel monitoring period RSS § 5.7.4 – Minimum channel monitoring period N/A N/A N/A EN § 10.4 – Channel access FCC § 95.627 (a)(4) – Channel access RSS § 5.7.5 – Channel access N/A N/A N/A EN § 10.5 – Discontinuation of MICS session 95.627 (a)(4) – Discontinuation of MICS session RSS § 5.7.6 – Discontinuation of MICS session Specified low-power radio equipment (Item 8 of Article 2 Paragraph 1 of Certification Ordinance) – Transmission suspension function due to interruption of communications N/A N/A N/A N/A EN § 10.6 – Use of pre-scanned alternate channel FCC § 95.627 (a)(5) – Use of pre-scanned alternate channel RSS § 5.7.7…
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SYRF V2 DF4 CRT-D174 FCC ID: YSGCRTD174 – Test set up photographs Radiated test set up photogr…
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| # | Rule Parts | Frequency Range | Power Output | Emission | Tolerance |
|---|---|---|---|---|---|
| 1 | 95I | 402 MHz - 405 MHz | 0.10 µW | 182KF1 | 9.8800000000 ppm |

Defibrillator
Equipment Class
DTS - Digital Transmission System
Smart Spot
Equipment Class
DCD - Part 15 Low Power Transmitter Below 1705 kHz
Implantable pacemaker with RF com
Equipment Class
DXX - Part 15 Low Power Communication Device Transmitter
Implantable pacemaker with RF com.
Equipment Class
DXX - Part 15 Low Power Communication Device Transmitter
Inductive programming head
Equipment Class
DCD - Part 15 Low Power Transmitter Below 1705 kHz