YSGSONRCRTD184Implantable cardioverter defibrillator

Implant manual Implantable cardioverter defibrillator SonR CRT-D model 184 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.MSP study...............................................................................................................................13 5.2.Potential adverse events.........................................................................................................14 6.Clinical studies......................................................................................................................16 6.1.MSP clinical study...................................................................................................................16 7.Patient selection and treatment...........................................................................................20 7.1.Individualization of treatment..................................................................................................20 7.2.Specific patient populations....................................................................................................21 8.Patient counselling information..........................................................................................22 9.Conformance to standards..................................................................................................23 10.Physician guidelines.............................................................................................................26 10.1.Physician training....................................................................................................................26 10.2.Directions for use....................................................................................................................26 10.3.Maintaining device quality.......................................................................................................26 10.4.V-V Programming Recommendation.......................................................................................27 11.Patient information...............................................................................................................28 12.How supplied.........................................................................................................................29 12.1.Sterility....................................................................................................................................29 12.2.Warranty and replacement policy............................................................................................29 13.Device description................................................................................................................30 14.Implant procedure.................................................................................................................32 14.1.Necessary equipment.............................................................................................................32 14.2.Packaging...............................................................................................................................32 14.3.Optional equipment.................................................................................................................32 14.4.Before opening the package...................................................................................................33 14.5.Prior to implantation................................................................................................................33 14.6.Device placement....................................................................................................................33 14.7.Choosing the type of lead.......................................................................................................33 14.8.Shock configuration (+ -> -).....................................................................................................34 14.9.Measurement of thresholds at implant....................................................................................34 14.10.Leads connection....................................................................................................................35 14.11.Device implantation.................................................................................................................36 14.12.Tests and programming...........................................................................................................36 15.Special modes.......................................................................................................................37 15.1.Safety mode (nominal values).............................…

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U129A U129-2 CRT-D 184 CRT-D 184 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 184 CRT-D 184 CRT-D 184 CRT-D 184 CRT-D 184 CRT-D 184 CRT-D 184 CRT-D 184 CRT-D 184 CRT-D 184 CRT-D 184 CRT-D 184 CRT-D 184 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 U129-1 FCC ID YSGSONRCRTD184 IC: 10270A-SONRCRTD184 (year-month-day) (year-month-day) 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 184 DF- 4 LLHH IS-1 BI Unipolar compatible IS-1 BI SONR 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 U130-1 U130-2 VVED-DDDRV U130-3 U130A CRT-D 184 VVED-DDDRV CRT-D 184 VVED-DDDRV VVED-DDDRV CRT-D 184 CRT-D 184 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 BIUnipolar compatible IS-1 BI S ON R DF- 4 LLHH IS-1 BI Unipolar compatible IS-1 BI S ONR DF- 4 LLHH IS-1 BIUnipolar compatible IS-1 BI S ON R Manufactured in Italy by: Sorin Group Italia S.r.l. Via Crescentino s.n. 13040 Saluggia (VC) - ITALY Use by (year-month-day) Serial number Serial number Use by (year-month-day) Date of manufacture (year-month-day) Sterilization lot number Serial number Use by (year-month-day) FCC ID YSGSONRCRTD184 IC: 10270A-SONRCRTD184 Sterilized using ethylene oxide High voltage CD-ROM  Consult instructions for use 0°C 50°C Temperature limitation

SYRF V2 DF4 SonR CRT-D184 FCC ID: YSGSONRCRTD184 – 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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PREPARE PAR LE VERIFIE PAR LE APPROUVE PAR LE DOCUMENT SC0T421D.doc PAGE 1/8 DOCUMENTOFFICIEL Type de document :SPECIFICATION COMPOSANTRéférence du document:SC0T421D Créé le :06/09/06Modifié le :19/11/07Avis de modification :AM014845 Titre :120 mH TELEMETRY COIL LISTE DE DIFFUSION Services concernés Achats Affaires Réglementaires Assurance Qualité Atelier bonding Atelier hybride Clinique Conditionnement Contrôle entrée électrique Contrôle entrée mécanique Contrôle entrée puce Finition Intégration Logistique Magasin Ordonnancement Marketing Méthodes Périphérique Recherche INTERNE Sorin SOCIETES EXTERNES ASICA CODEX DORVIT FIRSTEC Filiales allemandes Filiales US INEX INTEGRAL PROCESS KONTRON PORGES SELCO STAE AUTRE (préciser) DOCUMENT SC0T421D.doc PAGE 2/8 DOCUMENT OFFICIEL TABLE DES MATIERES 1.INTENDED USE .........................................................................................................................................................3 2.IDENTIFICATION .....................................................................................................................................................3 3.RAW MATERIALS REQUIREMENTS ....................................................................................................................3 3.1.WIREPURCHASESPECIFICATION .................................................................................................................3 3.2.WIRECERTIFICATEOFCONFORMANCE ......................................................................................................4 4.PHYSICAL AND ELECTRICAL INSPECTION FOR FINISHED COILS .............................................................4 5.QUALITY CONFORMANCE INSPECTION............................................................................................................5 5.1.ATSUPPLIER .....................................................................................................................................................5 5.2.ATCUSTOMER.................................................................................................................................................. 5 6.TRACEABILITY REQUIREMENTS........................................................................................................................6 7.PACKAGING AND LABELING................................................................................................................................6 7.1.OUTERPACKAGING.........................................................................................................................................6 7.2.INNERPACKAGING..........................................................................................................................................7 7.3.CERTIFICATEOFCONFORMANCE.................................................................................................................7 8.ELECTRICAL, MECHANICAL AND PHYSICAL REQUIREMENTS..................................................................8 DOCUMENT SC0T421D.doc PAGE 3/8 DOCUMENT OFFICIEL 1.INTENDED USE This specification describes a miniature coil for implantable telemetric devices. 2.IDENTIFICATION Customer part number :SC0T421D Manufacturers and specific technical specification reference : Z08-31-CHI MANUFACTURERSPECIFICATION ADD-ON Intricon Tibbetts corp.1SC0T421+last revision 3.RAW MATERIALS REQUIREMENTS The requirements in this section apply to magnet wire used in these coils. 3.1.WIRE PURCHASE SPECIFICATION Supplier shall establish and maintain a written purchase specification. This document shall specify : Wire size Overall–diameter range Insulation Enameling machine Wire lubrication Test Certificate for Magnet Wire, Level 1 with EAPC Test data for Lubrication (with manufacturing limits) DOCUMENT SC0T421D.doc PAGE 4/8 DOCUMENT OFFICIEL 3.2.WIRE CERTIFICATE OF CONFORMANCE Supplier shall require a Test Certificate for Magnet Wire, Level 1 with EAPC from wire manufacturer for each wire lot, containing as a minimum: Certification of conformance Reference to wire purchase specification Overall diameter Insulation cures data Lubrication data Mechanical properties 4.PHYSICAL AND ELECTRICAL INSPECTION FOR FINISHED COILS Materials and dimensions shall be as specified in Appendix I, attached. All (100 % of) coils shall be exposed to 140_C minimum for 3 hours minimum. This high- temperature storage may be performed prior to application of protective coating. After completion of this high–temperature storage, all (100 % of) finished coils shall be tested for conformance to physical parameters and electrical parameters as specified in Appendix I. Any of the following visual defects shall also be cause for rejection (10 x magnifications): Coating that is not cured to a tack free condition Coating with thickness insufficient to fill valleys between individual winding wires Coating that has pulled away or pulls away from the lead wires Coating with any bubble that has a dimension exceeding twice the end disc thickness Coating with any bubble that is broken Foreign material in contact with any wire, including lead wires and winding Foreign material that is not completely embedded Foreign material, or intentional material, outside the end disc diameter that renders the overall dimension of the coil, out of specification Lead connection with any loop or solder bridging between the lead wire and the winding wire Lead connection without at least one complete wrap of the winding wire around the lead wire Lead with any damage to insulation (where insulation is designed to be present) Lead with any damage to wire Winding turn displaced or moved from its correct wound position Winding with any damage to insulation (where insulation is designed to be present) Winding with any damage to wire DOCUMENT SC0T421D.doc PAGE 5/8 DOCUMENT OFFICIEL Winding with any unsupported wire (leaving visible space between winding and coil body) except …

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MORE DETAILS for question 9:

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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INTENSIA SonR CRT-D 184 The document titled ‘cover letter FCC for question 11’ indicates that model CRT-D 184 and CRT-D 9770 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 SonR CRT-D 9770 has 5 ports: Atrium: SonR, Right ventricle: IS-1, DF-1, Left ventricle: IS-1. INTENSIA SonR CRT-D 184 has 3 ports: Atrium: SonR, Right ventricle: DF-4, Left ventricle: IS-1. Paradym RF SonR CRT-D 9770 (header with SonR, 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 5 lead cavities have roughly the same diameters 3,7 mm and located both sides of the 11,5 mm width header. Intensia SonR CRT-D 184 (header with SonR, IS-1 & DF-4 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).

OFFICI…

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