MISC1582B for question 7

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Document Name / Nome documento / Nom du document OFFICIAL DOCUMENT MISC1582B Type of document / Tipo di documento / Type de document Technical Note Project Department: Original stored in: Department Internal Ref: Syndeli RF V2 DF4 COE-IDS Clamart ELECTRONIC RELEASE CERTIFIED COMPLIANT TO THE ORIGINAL SIGNED AND APPROVED DOCUMENT Title: Filed in Intraprod on : SYNDELI RF V2 DF4: CHANGES VALIDATION VERSUS PARADYM RF JPN RDY 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 10th, 2013 Verified by C. de Jeso QA CT member Verified by G. Salaün RA CT member Approved by P. Barou CT Leader 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.

Document Name / Nome documento / Nom du document OFFICIAL DOCUMENT MISC1582B HISTORY / STORIA / HISTORIQUE Rev. Change Reason for Change Release date ELECTRONIC RELEASE CERTIFIED COMPLIANT TO THE ORIGINAL SIGNED AND APPROVED DOCUMENT A Original document in English New project SYRF V2 with DF4 headers Dec. 5th, 2012 - Editorial correction of reference of document - Previously wrongly referenced MISC1633 SYNDELI RF V2 DF4 Inductive telemetry instead of MISC1663 performances B - Versioning update - New revision of PLAN0694D and REP0776D - SAR evaluation is fully covered by - Removed rev. D of MISC0513 MISC1665A 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.

Document Name / Nome documento / Nom du document OFFICIAL DOCUMENT MISC1582B TABLE OF CONTENT / INDICE / TABLE DES MATIERES ELECTRONIC RELEASE CERTIFIED COMPLIANT TO THE ORIGINAL SIGNED AND APPROVED DOCUMENT 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 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.

Document Name / Nome documento / Nom du document OFFICIAL DOCUMENT MISC1582B 1 Scope This document lists, based on design changes (DF4 new headers), the complete Syndeli RF V2 DF4 ELECTRONIC RELEASE CERTIFIED COMPLIANT TO THE ORIGINAL SIGNED AND APPROVED DOCUMENT V&V that has to be done according to the following three kind of methods : Redo tests already performed for PARADYM RF JPN RDY V&V, Apply PARADYM RF JPN RDY exisiting plans & reports with justifications, 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: REQ0964 Paradym RF, Paradym V2 & Tri-V, Syndeli RF V2 - Functional Specifications REQ0947 Syndeli RF & Syndeli RF V2 DF4 models and ZL modules serial number encoding CR00245 DF4 Headers Design Review meeting minutes CR00304 Syndeli RF V2 DF4 Specification Review meeting minutes MISC1134 Syndeli RF JPN RDY : Changes validation versus Syndeli RF 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.

Document Name / Nome documento / Nom du document OFFICIAL DOCUMENT MISC1582B 3 Design changes, Background 3.1 Mechanics The table below describes all the design changes introduced on those header parts potentially ELECTRONIC RELEASE CERTIFIED COMPLIANT TO THE ORIGINAL SIGNED AND APPROVED DOCUMENT inducing electronics or system performances impacts: Headers Change Reason for change Moved to 1 DF-4 cavity from previous 2 DF-1 Respond to market new standard needs cavities & 1 IS-1 cavity DF4 cavity bigger diameter do not allow the 3D shape RF antennas vs. Flat RF antenna integration of the RF antenna in the center DF4 headers plan of the header Vs 2 different RF antennas: Downsized for VR header - a large one for CRT-D SonR, CRT-D & DR DF1 headers - a small one for VR DF4 cavity contact blocks location in the DF4 Main feed-through wires new routing inside the header is not the same as in current DF1 header and contact blocks relocation headers 3.2 Electronics Syndeli RF V2 DF4 products are fully based on Paradym RF JPN ready electronic platform. 3.3 Embedded Software Syndeli RF V2 DF4 range of devices embeds the same software as Paradym RF JPN Ready, W3.120.1. 4 Syndeli RF V2 DF4 devices identification versus Paradym RF JPN Rdy ones There’s no featuring difference between PARADYM RF JPN RDY and Syndeli RF V2 DF4 one, therefore the same codification of LV hybrid will be used. Finally we have the following codification & parts constitution: Generic Device Project range Model Code Code CRT-D SonR AD CRT-D AE Syndeli RF V2 DF4 Y6 DR AF VR AG 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.

LECTRONIC RELEASE CERTIFIED COMPLIANT TO THE ORIGINAL SIGNED AND APPROVED DOCUME Document Name / Nome documento / Nom du document OFFICIAL DOCUMENT MISC1582B 5 Device definition mapping Electronic platform Connector Family Model Software Common parts Differences Shape Cavities VR - TWAV4C & MOSAIC - One header shape for all 3 cavities: 1 IS-1 and 2 DF-1 DR RF2 chipset models with insulated RF 4 cavities: 2 IS-1 and 2 DF-1 - “Y6” Low voltage antenna PARADYM RF JPN RDY CRT-D 5 cavities: 3 IS-1 and 2 DF-1 hybrid with RF lead frame option 5 cavities: 3 IS-1 and 2 DF-1 CRT-D SonR - SMD Third cavity IS-1 with additional components on contact in atrial cavity SonR VR Low Voltage None W3.120.1 - Two headers shapes: 1 cavity: 1 DF-4 DR hybrid and main * 1 header for SonR, 2 cavities: 1 IS-1 and 1 DF-4 CRT-D flex CRT-D & DR models 3 cavities: 2 IS-1 and 1 DF-4 - Shock7 V2 * 1 low profile header Syndeli RF V2 – DF-4 for VR model - RF module ZL70102 3 cavities: 2 IS-1 and 1 DF-4 CRT-D SonR - Battery Second cavity IS-1 with additional - HV capacitors contact in atrial cavity SonR FF00929C - DHF Page 6/16 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.

Document Name / Nome documento / Nom du document OFFICIAL DOCUMENT MISC1582B 6 Device under test selection The tests have to be performed on Syndeli RF V2 DF4 CRT-D SonR model because: ELECTRONIC RELEASE CERTIFIED COMPLIANT TO THE ORIGINAL SIGNED AND APPROVED DOCUMENT this is the most complete model in terms of functionalities and quantity of contact blocks VR DF4 cavity location & design is fully the same as CRT-D SonR one and consequently covers all range of the Syndeli RF V2 DF4 families. Therefore validation reports will be applicable on all Syndeli RF V2 DF4 models. FF00929C - DHF Page 7/16 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.

Document Name / Nome documento / Nom du document OFFICIAL DOCUMENT MISC1582B 7 Syndeli RF V2 DF4 V&V versus Paradym RF JPN Rdy V&V source The table below describes, based on PARADYM RF JPN Rdy V&V plans and reports and the SYNDELI RF ELECTRONIC RELEASE CERTIFIED COMPLIANT TO THE ORIGINAL SIGNED AND APPROVED DOCUMENT V2 DF4 design changes, all the tests to be either added or redo and those which have been already performed and consequently for which the results are applicable to SYNDELI RF V2 by rationales based on designs comparison (new DF4 connector block vs. DF1 one). PARADYM RF JPN RDY qualification reports eligible Step Test Source Test description for Syndeli RF V2 DF4 ? Status Justification This protocol is intended to qualify the use of PLAN699C CC7 crystal with the oscillator on the Low Voltage hybrid in PARADYM RF JPN RDY 1 Yes Same Y6 Hybrid This document bears the whole qualification results REP0783C of the new CC7 crystal oscillator of PARADYM RF JPN RDY - These protocols are intended to validate the Same Y6 Hybrid PLAN0700B G Chain on the Low Voltage hybrid RF in PARADYM RF JPN RDY 2 Yes This document bears the whole qualification REP0784B results of the G Chain of PARADYM RF JPN RDY -This protocol is intended to verify the non Same Y6 Hybrid regression of Low Voltage hybrid Y6 compared PLAN0841B to Low Voltage hybrid Y3 using in PARADYM Yes 3 JPN RDY This document bears the whole qualification results REP1061B of the no regression test on Low Voltage hybrid. PLAN1252A -This protocol is intended to validate the Same Y6 Hybrid including MV sensor validation modification of MOSAIC RF V2 compared to MOSAIC RF V2 using in the Low Voltage hybrid RF - This protocol is intended to validate the PLAN0758C modification of MOSAIC RF compared to MOSAIC V2B Yes 4 PLAN0841A -This protocol is intended to validate the non regression of MOSAIC RF compared to MOSAIC V2B using in the Low Voltage hybrid Y4 and RF REP0891B These documents bear the whole qualification REP1061B results of the IC MOSAIC RF & MOSAIC RF V2 REP1932A FF00929C - DHF Page 8/16 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.

Document Name / Nome documento / Nom du document OFFICIAL DOCUMENT MISC1582B PARADYM RF JPN RDY qualification reports eligible Step Test Source Test description for Syndeli RF V2 DF4 ? ELECTRONIC RELEASE CERTIFIED COMPLIANT TO THE ORIGINAL SIGNED AND APPROVED DOCUMENT Status Justification -This protocol is intended to validate the Same Y6 Hybrid including MV sensor validation PLAN1252A modification of TWINACE V4C compared to TWINACE V4B using in the Low Voltage hybrid RF -This protocol is intended to validate the PLAN0698B modification of TWINACE V4B compared to TWINACE V3B using in the Low Voltage hybrid RF PLAN0759B -This protocol is intended to validate the modification of TWINACE V3B compared to Yes 5 TWINACE V2 using in the Low Voltage hybrid Y4 and RF -This protocol is intended to validate the non PLAN0841B regression tests of TWINACE V3B compared to TWINACE V2 using in the Low Voltage hybrid Y4 and RF REP0892B These documents bear the whole qualification REP1140B results of the Integrated Circuit TWINACE V4C REP1061B TWINACE V4B and TWINACE V3B REP1932A This protocol is intended to validate the Same Main flex assembly PLAN0703B sensing chain in the main FLEX or finished product PARADYM RF JPN RDY No 6 This document bears the whole qualification REP0787B results of the Sensing chain of PARADYM RF JPN RDY. This protocol is intended to validate the Same device design as JPN RDY, but influence of PLAN0705B Inductive telemetry performances on finished DF4 header to be evaluated for Inductive product PARADYM RF JPN RDY. Yes, communication performance standpoint 7 This document bears the whole qualification partially REP0789B results of the inductive telemetry performances of PARADYM RF JPN RDY. This protocol is intended to verify immunity of Same device design as JPN RDY, but influence of the final device against EMI emissions and DF4 lead bore to be evaluated for EMI standpoint internal or external perturbations to show (§27.4 & 27.5) PLAN0695B compliance with EN 45502-2-1: 2003 and EN 45502-2-2: 2008 applicable to the Implantable Yes, 8 Cardioverter Defibrillator partially This document bears the whole qualification results of the standard EN 45502-2-2: 2008 sections {16.2, REP0777B 16.4, 16.5, 17.1, 19.2, 19.5, 20.2, 21.2, 22.1, 27.2, 27.3, 27.4, 27.5, 27.6, 27.7 and 27.8} of PARADYM RF JPN RDY. FF00929C - DHF Page 9/16 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.

Document Name / Nome documento / Nom du document OFFICIAL DOCUMENT MISC1582B PARADYM RF JPN RDY qualification reports eligible Step Test Source Test description for Syndeli RF V2 DF4 ? Status Justification This protocol is intended to measure the Same device design as JPN RDY, but influence of ELECTRONIC RELEASE CERTIFIED COMPLIANT TO THE ORIGINAL SIGNED AND APPROVED DOCUMENT characteristics on final device according to new header to be evaluated for sensing, EMI, PLAN0694D standards EN 45502-2-1: 2003 and EN pacing & shock characteristics standpoint (PC69, 45502-2-2: 2008 §6.1.1. & 6.1.4). This document bears the whole Atrial ATP characteristics to be evaluated qualification results of the standards EN Other previous tests results related to timing are 9 still eligible. 45502-2-1: 2003 (see sections 10.1 to 10.14 for tests of §6.1.1 to 6.1.9 of the REP0776D standard) and EN 45502-2-2: 2008 (see Yes, sections 10.16 to 10.19 for tests of §6.1.2 partially to 6.1.6 of the standard) and PARADYM RF JPN RDY. This protocol is intended to describe the tests to be carried out on the device to PLAN0696B show compliance with standard 10 AAMI:PC69:2007 This document bears the whole qualification REP0778C results of the safety test of STANDARD AAMI:PC69:2007 of PARADYM RF This protocol is intended to qualify Same device design as JPN RDY (electronics and PARADYM RF JPN RDY ICD immunity and feeds-though) PLAN0704A functionality against internal RF emissions and perturbations 11 This document bears the whole Yes qualification results of ICD immunity and REP0788A functionality against internal Radio- Frequency (RF) emissions and perturbations of PARADYM RF JPN RDY. These reports bear the whole of RF Same Electronics & Mechanics as Paradym RF JPN ZL70102 feature results with respect to RDY for the DF1 version but DF4 header impact has STDs for PARADYM RF JPN RDY models to be evaluated for radiated power & cells damages (EC, US & JPN compliance) REP2101B VR, EMC LCIE report DR, EMC LCIE report CRT, EMC LCIE report Yes, 12 SonR EMC LCIE report partially VR, RADIO LCIE report DR, RADIO LCIE report CRT, RADIO LCIE report SonR, RADIO LCIE report All models, EMF (Human exposure) report MISC0513C SAR simulation report FF00929C - DHF Page 10/16 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.

Document Name / Nome documento / Nom du document OFFICIAL DOCUMENT MISC1582B PARADYM RF JPN RDY qualification reports eligible Step Test Source Test description for Syndeli RF V2 DF4 ? Status Justification This document bears the whole of tests Same Y6 main flex assembly. ELECTRONIC RELEASE CERTIFIED COMPLIANT TO THE ORIGINAL SIGNED AND APPROVED DOCUMENT performed for validating the assembly PLAN0676B technology reliability of the “Y6” main flex assembly encompassing all the electronics (dice & SMD) except the RF module. 13 This document bears the whole of tests results Yes for validating the assembly technology REP1290B reliability of the “Y6” main flex assembly encompassing all the electronics (dice & SMD) except the RF module. This document bears the whole of tests ZL70102 new module do not require any performed for validating the assembly further qualification at RF flex assembly level PLAN0678A technology reliability of the RF ZL70101 flex because no Sorin assembly process change assembly encompassing all the electronics (dice has been introduced, see MISC1134 14 & SMD). Yes This document bears the whole of tests results for validating the assembly technology REP0745A reliability of the RF ZL70101 flex assembly encompassing all the electronics (dice & SMD). This protocol is intended to qualify the ICD, Same RF ZL70102 module ZL70102 inside RF communication PLAN1253A performances with Smart View Quick-fix Home 15 Monitor (shielded version) Yes This document bears the whole qualification REP1933A results of the ICD ZL70102 inside RF communication performances This document bears the whole of tests Same RF ZL70102 module PLAN1261B performed for validating the assembly technology reliability of the RF ZL70102 module 16 This document bears the whole of tests results Yes REP1961A for validating the assembly technology reliability of the RF ZL70102 module These documents bear the whole qualification Same Y6 Hybrid, but for mechanics, new DF4 tests & results performed by the LCIE certified headers: contact blocks location & main FT 17 REP2100A lab. for insuring ICD & CRT compliance with No wires new routing in the header respect to EN45502 & AAMI/PC69 series STDs. This protocol bears the whole of Same ESW3.120.1 qualification tests for validating the PLAN1105A PARADYM RF JPN RDY devices ESW 18 W3.120.1 Yes This report bears the whole of qualification REP1949A tests results for validating the PARADYM RF JPN RDY devices ESW W3.120.1 This document bears the tests protocols to be - Same Y6 Hybrid & Mechanics as Paradym RF performed internally and by the LCIE certified JPN RDY except the new DF4 header PROTER1N lab. for insuring ICD & CRT compliance with respect to EN45502 series 19 These documents bear the results of the whole Yes, partially qualification tests performed internally and by REP1156A the LCIE certified lab. for insuring ICD & CRT compliance with respect to EN45502 series FF00929C - DHF Page 11/16 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.

Document Name / Nome documento / Nom du document OFFICIAL DOCUMENT MISC1582B PARADYM RF JPN RDY qualification reports eligible Step Test Source Test description for Syndeli RF V2 DF4 ? Status Justification ELECTRONIC RELEASE CERTIFIED COMPLIANT TO THE ORIGINAL SIGNED AND APPROVED DOCUMENT This document bears the tests protocol to be same electronics and mechanics as Paradym PROTER4J performed to ensure ICD & CRT compliance RF JPN RDY but new header with IS-1 cavities with respect to IS-1 and DF-1 standards and DF4 cavity impact has to be evaluated 20 These documents bear the whole qualification No tests & results performed to ensure ICD & CRT REP1155A compliance with respect to IS-1 and DF-1 standards This document bears the protocols of tests to new DF4 header impact has to be evaluated be performed to assess the biological effects of the PARADYM RF following the requirements of 21 MISC0482A ISO 10993: Biological Evaluation of Medical No Devices, as well as the tests results demonstrating ICD & CRT compliance to this standard. This document bears the protocols of tests to new DF4 header impact has to be evaluated PLAN0950A be performed to validate the Ethylene Oxide Sterilization BC1 cycle 22 No This document bears the tests results of the REP1308B Ethylene Oxide Sterilization BC1 cycle validation This process validation protocol defines the Same external blister tests and associated acceptance criteria to comply PROTER16D with requirements relative to the validation of the sterile packaging sealing process used for sterile barrier systems in accordance with ISO 24 11607-2:2006, ISO 11607-1:2006 standards and Yes a GHTF guidance This document bears the tests results details REP1167D the test-results regarding the sterile barrier system sealing FF00929C - DHF Page 12/16 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.

Document Name / Nome documento / Nom du document OFFICIAL DOCUMENT MISC1582B 8 Syndeli RF V2 DF4 V&V, DHF References mapping The table below describes all the V&V that have to be redone for validating all Syndeli RF V2 DF4 devices range. It’s, based on existing PARADYM RF JPN RDY, and DF4 headers design impact on ELECTRONIC RELEASE CERTIFIED COMPLIANT TO THE ORIGINAL SIGNED AND APPROVED DOCUMENT devices performances (refer to the DF4 Design Review meeting minutes CR00245A, slide V&V). For all remaining SYNDELI RF V2 DF4 Mechanics, Electronics & Process V&V (common design & risk management) refer to PARADYM RF JPN RDY existing DHF. PARADYM RF JPN RDY source Syndeli RF V2 DF4 V&V GENERAL PLAN Step DHF Source Test description DHF Ref Test description This protocol is intended to validate the MISC1663A This document bears the whole qualification PLAN0705B Inductive telemetry performances on + PLAN705B results of the inductive telemetry finished product PARADYM RF JPN RDY. as precedence performances of Syndeli RF V2 DF4 for what 1 regards the following test: This document bears the whole MISC1663A - EPS cone area versus Paradym RF DF1 one qualification results of the inductive Others PARADYM RF JPN RDY test results are REP0789B telemetry performances of PARADYM RF + REP0789B as precedence eligible JPN RDY This protocol is intended to verify immunity of the final device against EMI emissions and internal or external PLAN1554A This document bears the whole qualification results PLAN0695B perturbations to show compliance with EN + PLAN0695B of the standard EN 45502-2-2: 2008 sections 45502-2-1: 2003 and EN 45502-2-2: 2008 as precedence performed on Syndeli RF V2 DF4 for what regards: applicable to the Implantable Cardioverter 2 Defibrillator - EMI compatibility (§27.4, 27.5) - CMRR This document bears the whole qualification Others PARADYM RF JPN RDY test results are results of the standard EN 45502-2-2: 2008 REP2499A eligible REP0777B sections {16.2, 16.4, 16.5, 17.1, 19.2, 19.5, 20.2, + REP0777B 21.2, 22.1, 27.2, 27.3, 27.4, 27.5, 27.6, 27.7 and as precedence 27.8} of PARADYM RF JPN RDY. This protocol is intended to measure the PLAN1555A characteristics on final device according to This document bears the whole qualification PLAN0694D standards EN 45502-2-1: 2003 and EN + PLAN0694D results of the standards EN 45502-2-1: 2003 45502-2-2: 2008 as precedence and EN 45502-2-2: 2008 performed on Syndeli This document bears the whole RF V2 DF4 for what regards the following tests: qualification results of the standards EN - RV & A Sensing 3 - LV, RV, A Pacing 45502-2-1: 2003 (see sections 10.1 to REP2500A - Shock 10.14 for tests of §6.1.1 to 6.1.9 of the REP0776D standard) and EN 45502-2-2: 2008 (see + REP0776D - RV & A ATP sections 10.16 to 10.19 for tests of §6.1.2 as precedence Others PARADYM RF JPN RDY test results are to 6.1.6 of the standard) and PARADYM RF eligible JPN RDY. FF00929C - DHF Page 13/16 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.

Document Name / Nome documento / Nom du document OFFICIAL DOCUMENT MISC1582B PARADYM RF JPN RDY source Syndeli RF V2 DF4 V&V GENERAL PLAN Step DHF Source Test description DHF Ref Test description This protocol is intended to describe the ELECTRONIC RELEASE CERTIFIED COMPLIANT TO THE ORIGINAL SIGNED AND APPROVED DOCUMENT tests to be carried out on the device to PLAN696B show compliance with standard PLAN1556A This document bears the whole qualification results of 4 AAMI:PC69:2007 the safety test of Standard AAMI PC69:2007 of Syndeli This document bears the whole qualification RF V2 DF4 for all tests. REP778C results of the safety test of STANDARD REP2501A AAMI:PC69:2007 of PARADYM RF The protocol is intended to qualify the RF system communication performances comprising both IMD & Smartview monitor, and the technical note describes This protocol is intended to qualify the RF PLAN1253A the whole qualification strategy of the RF system PLAN1253A system communication performances as precedence communication of Syndeli RF V2 DF4 (high & low profile comprising both IMD & Smartview monitor + MISC1239A header) devices through design assessment (simulation and characterization) for what regards the effective communication distance range 5 The technical note bears the whole design validation tests performed on Syndeli RF V2 DF4 This document bears the whole qualification (high & low profile header) for what regards the REP1933A results of ICD RF system communication following test : REP1933A performance during operation with the as precedence - ISM & MICS band distance range versus Paradym Smartview Monitor. + MISC1239A RF JPN RDY DF1 ones Others PARADYM RF JPN RDY test results are eligible These reports bear the whole of RF These reports bear the whole of RF ZL70102 ZL70102 feature results with respect to feature results with respect to STDs for Syndeli RF STDs for PARADYM RF JPN RDY models V2 DF4 & LCIE reports of precedence (EC, US & JPN (EC, US & JPN compliance) compliance) VR, EMC LCIE report VR, EMC LCIE report REP2101B DR, EMC LCIE report REP2482A DR, EMC LCIE report CRT, EMC LCIE report CRT, EMC LCIE report SonR, EMC LCIE report SonR, EMC LCIE report 6 VR, RADIO LCIE report VR, RADIO LCIE report DR, RADIO LCIE report DR, RADIO LCIE report CRT, RADIO LCIE report CRT, RADIO LCIE report SonR, RADIO LCIE report SonR, RADIO LCIE report All models, EMF (Human exposure) All models, EMF (Human exposure) report report MISC0513C SAR simulation report MISC1665A SAR simulation report for Syndeli RF V2 DF4 This report bears the whole qualification tests This report bears the whole qualification tests results & previous results performed by the LCIE on performed by the LCIE on Syndeli RF V2 DF4 (high & low PARADYM RF JPN RDY and rationales. profile header) & LCIE reports of precedence 7 REP2100A VR, 45502 EN series LCIE report REP2483A VR, 45502 EN series LCIE report DR, 45502 EN series LCIE report DR, 45502 EN series LCIE report CRT, 45502 EN series LCIE report CRT, 45502 EN series LCIE report SonR, 45502 EN series LCIE report SonR, 45502 EN series LCIE report FF00929C - DHF Page 14/16 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.

Document Name / Nome documento / Nom du document OFFICIAL DOCUMENT MISC1582B PARADYM RF JPN RDY source Syndeli RF V2 DF4 V&V GENERAL PLAN Step DHF Source Test description DHF Ref Test description ELECTRONIC RELEASE CERTIFIED COMPLIANT TO THE ORIGINAL SIGNED AND APPROVED DOCUMENT This document bears the tests protocol to be This document bears the tests protocol to be performed internally and by the LNE certified performed internally and by the LNE certified lab. PROTER1N lab. for insuring ICD & CRT compliance with PROTER1O for insuring Syndeli RF DF4 compliance with respect respect to EN45502 environmental tests to EN45502 requirements 8 This document bears the results of the whole These documents bear the results of the whole qualification tests performed internally and by qualification tests performed internally, by the LNE REP2481A REP1156A the LCIE certified lab. for insuring ICD & CRT certified lab., and rationale to demonstrate compliance with respect to EN45502 MISC1775A previous tests results are eligible for ensuring environmental tests requirements Syndeli RF DF4 compliance with respect to EN45502 This document bears the tests protocol to be This document bears the tests protocol to be PROTER4J performed to ensure ICD & CRT compliance PROTER22A performed to ensure Syndeli RF V2 DF4 compliance with respect to IS-1 and DF-1 standards with respect to IS-1 and DF-4 standards 9 These documents bear the whole qualification These documents bear the whole qualification tests tests & results performed to ensure ICD & CRT REP1155B compliance with respect to IS-1 and DF-1 REP2430A & results performed to ensure ICD & CRT compliance with respect to IS-1 and DF-4 standards standards This document bears the protocols of tests to This document bears the protocols of tests to be be performed to assess the biological effects of performed to assess the biological effects of the the PARADYM RF following the requirements of Syndeli RF V2 DF4 following the requirements of ISO 10 MISC0482A ISO 10993: Biological Evaluation of Medical MISC1584A 10993: Biological Evaluation of Medical Devices, as Devices, as well as the tests results well as the tests results demonstrating ICD & CRT demonstrating ICD & CRT compliance to this compliance to this standard. standard. This document bears the protocols of tests to PLAN0950A be performed to validate the Ethylene Oxide This document bears the rational which Sterilization BC1 cycle 11 MISC1611A demonstrates the results obtained in SYRF V1 are fully applicable to SYRF V2 DF4 This document bears the tests results of the REP1308B Ethylene Oxide Sterilization BC1 cycle validation FF00929C - DHF Page 15/16 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.

Document Name / Nome documento / Nom du document OFFICIAL DOCUMENT MISC1582B PARADYM RF JPN RDY source Syndeli RF V2 DF4 V&V GENERAL PLAN Step DHF Source Test description DHF Ref Test description This document bears the protocol of tests to be This document bears the protocol of tests & ELECTRONIC RELEASE CERTIFIED COMPLIANT TO THE ORIGINAL SIGNED AND APPROVED DOCUMENT PLAN0670C performed to validate the DF1 headers SonR PLAN1515B measurements to be performed to validate the DF4 CRT-D, CRT-D, DR and VR versions headers SonR CRT-D, CRT-D, DR and VR versions 12 REP0738C These documents bear the whole component REP2424A These documents bear the whole component REP0739C qualification results of the DF1 headers SonR qualification results of the DF4 headers SonR CRT-D, REP0852D CRT-D, CRT-D, DR and VR versions CRT-D, DR and VR versions REP2427A REP0853D This document bears the protocol of tests & This document bears the protocol of tests to be PLAN0669A performed to validate the DF1 wedge PLAN1519A measurements to be performed to validate the DF4 wedge 13 This document bears the whole component This document bears the whole component REP0737A qualification results of the DF1 wedge REP2428A qualification results of the DF4 wedge This document bears the protocol of tests & PLAN1520A measurements to be performed to validate the DF4 This document bears the whole component top silicone cap 14 QC00673A qualification results of the DF1 top silicone cap This document bears the whole component REP2429A qualification results of the DF4 top silicone cap FF00929C - DHF Page 16/16 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.


Document Created: 2013-12-17 14:37:38
Document Modified: 2013-12-17 14:37:38
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