YSGVR124Implantable cardioverter defibrillator

Implant manual Implantable cardioverter defibrillator VR model 124 blank blank TABLE OF CONTENTS 1.General description................................................................................................................5 2.Indications...............................................................................................................................6 3.Contraindications....................................................................................................................7 4.Warnings and precautions.....................................................................................................8 4.1.Risks related to medical environment.......................................................................................9 4.2.Sterilization, storage and handling..........................................................................................10 4.3.Implantation and device programming....................................................................................10 4.4.Lead evaluation and lead connection......................................................................................11 4.5.Generator explant and disposal..............................................................................................12 5.Adverse events......................................................................................................................13 5.1.Defender study........................................................................................................................13 6.Clinical studies......................................................................................................................15 6.1.Defender study........................................................................................................................15 7.Patient selection and treatment...........................................................................................18 7.1.Individualization of treatment..................................................................................................18 7.2.Specific patient populations....................................................................................................19 8.Patient counselling information..........................................................................................20 9.Conformance to standards..................................................................................................21 10.Physician guidelines.............................................................................................................24 10.1.Physician training....................................................................................................................24 10.2.Directions for use....................................................................................................................24 10.3.Maintaining device quality.......................................................................................................24 11.Patient information...............................................................................................................25 12.How supplied.........................................................................................................................26 12.1.Sterility....................................................................................................................................26 12.2.Warranty and replacement policy............................................................................................26 13.Device description................................................................................................................27 14.Implant procedure.................................................................................................................29 14.1.Necessary equipment.............................................................................................................29 14.2.Packaging...............................................................................................................................29 14.3.Optional equipment.................................................................................................................29 14.4.Before opening the package...................................................................................................29 14.5.Prior to implantation................................................................................................................30 14.6.Device placement....................................................................................................................30 14.7.Choosing the type of lead.......................................................................................................30 14.8.Shock configuration (+ -> -).....................................................................................................31 14.9.Measurement of thresholds at implant....................................................................................31 14.10.Lead connection .....................................................................................................................31 14.11.Device implantation.................................................................................................................33 14.12.Tests and programming...........................................................................................................33 15.Special modes.......................................................................................................................34 15.1.Safety mode (nominal values).................................................................................................34 15.2.Magnet mode..........................................................................................................................34 15.3.Response in the presence of interference............…

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U135A U135-2 VR 124 VR 124 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 VR 124 VR 124 VR 124 VR 124 VR 124 VR 124 VR 124 VR 124 VR 124 VR 124 VR 124 VR 124 VR 124 DF- 4 LLHH VVE-VVIR As-shipped parameters / Paramètres à l’expédition / Parameter bei Auslieferung / Valori da spedizione / Parámetros expedición (37°C, 500 X) : OFF 60 min -1 VVI 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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Ventricular antitachycardia pacing Single chamber arrhythmia detection VVIR antibradycardia pacing DÉFIBRILLATEUR CARDIOVERTEUR IMPLANTABLE Stimulation antitachycardique ventriculaire Détection simple chambre des arythmies Stimulation antibradycardique VVIR IMPLANTIERBARER KARDIOVERTER-DEFIBRILLATOR Ventrikuläre antitachykarde Stimulation Einkammer-Arrhythmie-Erkennung Antibradykarde VVIR-Stimulation DEFIBRILLATORE CARDIOVERTER IMPIANTABILE Stimolazione antitachicardica ventricolare Detezione monocamerale delle aritmie Stimolazione antibradicardica VVIR DESFIBRILADOR CARDIOVERSOR IMPLANTABLE Estimulación antitaquicárdica ventricular Detección monocameral de las arritmias Estimulación antibradicárdica VVIR U135-1 (year-month-day) (year-month-day) FCC ID YSGVR124 IC: 10270A-VR124 Manufactured in Italy by: Sorin Group Italia S.r.l. Via Crescentino s.n. 13040 Saluggia (VC) - ITALY VR 124 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 U136-1 U136-2 VVE-VVIR U136-3 U136A VVE-VVIR VVE-VVIR VVE-VVIR DEFIBRILLATORE CARDIOVERTER IMPIANTABILE Stimolazione antitachicardica ventricolare Detezione monocamerale delle aritmie Stimolazione antibradicardica VVIR DESFIBRILADOR CARDIOVERSOR IMPLANTABLE Estimulación antitaquicárdica ventricular Detección monocameral de las arritmias Estimulación antibradicárdica VVIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Ventricular antitachycardia pacing Single chamber arrhythmia detection VVIR antibradycardia pacing DÉFIBRILLATEUR CARDIOVERTEUR IMPLANTABLE Stimulation antitachycardique ventriculaire Détection simple chambre des arythmies Stimulation antibradycardique VVIR IMPLANTIERBARER KARDIOVERTER-DEFIBRILLATOR Ventrikuläre antitachykarde Stimulation Einkammer-Arrhythmie-Erkennung Antibradykarde VVIR-Stimulation *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 VVI 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 VR 124 VR 124 VR 124 VR 124 DF- 4 LLHH DF- 4 LLHH DF- 4 LLHH 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) Manufactured in Italy by: Sorin Group Italia S.r.l. Via Crescentino s.n. 13040 Saluggia (VC) - ITALY Sterilized using ethylene oxide High voltage CD-ROM  Consult instructions for use 0°C 50°C Temperature limitation FCC ID YSGVR124 IC: 10270A-VR124 Serial number Use by (year-month-day) Date of manufacture (year-month-day) Sterilization lot number Serial number Use by (year-month-day) Use by (year-month-day) Serial number

SYRF V2 DF4 VR124 FCC ID: YSGVR124 – 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 6:

INTENSIA VR 124 The document titled ‘cover letter FCC for question 8’ indicates that model VR 124 and VR 9250 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 (1 port vs 3). Paradym RF VR 9250 has 3 ports: IS-1, DF-1. INTENSIA VR 124 has 1 port: DF-4. Paradym RF VR 9550 (header with IS-1 & DF-1 lead cavities): 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 3 lead cavities have roughly the same diameters 3,7 mm and located both sides of the 11,5 mm width header. Intensia VR 124 (header with DF-4 lead cavity): The DF-4 cavity diameter being bigger (6,35 mm), we had to route RF antenna wire around the DF-4 cavity. The VR header has only 1 DF-4 lead cavity, so we have designed a header which is lower is height & volume than the other 3 models DR, CRT-D and SonR CRT-D). This header of lower volume & lower height is more comfortable to the patient. Please refer to the 2 pictures below (RF antenna highlighted in green in below 3D pictures).

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° 119405-638393K-Cr2014-01-20 Page 2 SUMMARY 1. TEST PROGRAM ............................................................................................................................... 3 2. EQUIPMENT DESCRIPT…

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