YSGKA351The Orchestra Plus Link

USER MANUAL KA 351 ORCHESTRA PLUS LINK TABLE OF CONTENTS 1. List of symbols .......................................................................................................................................................................................... 2 2. Symbols used in this manual ................................................................................................................................................................... 3 3. Introduction ................................................................................................................................................................................................ 4 4. User Profile................................................................................................................................................................................................. 5 5. Indication .................................................................................................................................................................................................... 6 6. Warnings and precautions ....................................................................................................................................................................... 7 6.1 Safety Precautions .......................................................................................................................................................................... 7 6.2 Precautions for safe operation ...................................................................................................................................................... 7 7. Package contents ...................................................................................................................................................................................... 8 8. Description ................................................................................................................................................................................................. 9 9. Using ORCHESTRA PLUS LINK ............................................................................................................................................................. 10 9.1 Setting-up ORCHESTRA PLUS LINK........................................................................................................................................... 10 9.2 Using the ORCHESTRA PLUS LINK ............................................................................................................................................ 10 9.3 Ensuring stable RF Communication ........................................................................................................................................... 11 9.4 ORCHESTRA PLUS LINK software update ................................................................................................................................. 11 10. ORCHESTRA PLUS LINK basic care ..................................................................................................................................................... 12 11. Maintenance and Recycling ................................................................................................................................................................... 13 11.1. Compatibility ................................................................................................................................................................................. 13 12. Troubleshooting ...................................................................................................................................................................................... 14 13. Technical specifications ......................................................................................................................................................................... 15 14. Declaration of conformity ....................................................................................................................................................................... 16 15. Guidance and manufacturer’s declaration ........................................................................................................................................... 19 15.1 Electromagnetic emissions .......................................................................................................................................................... 19 15.2 Electromagnetic immunity ........................................................................................................................................................... 19 15.3 Recommended separation distances between portable and mobile RF communications equipment and the ORCHESTRA PLUS LINK ............................................................................................................................................................. 20 16. Technical assistance ............................................................................................................................................................................... 21 1. LIST OF SYMBOLS 2 SORIN - ORCHESTRA PLUS LINK – U386A 1. LIST OF SYMBOLS FCC ID : YSGKA351 IC ID: 10270A-KA351 This symbol is used to encourage you to consult the documentation and manual enclosed in the packaging. FCC icon This symbol confers the approval of the US Federal Communications Commission. Name and address of the manufacturer Serial number Keep the device dry. Keep it away from liquids and do not spill or drip water on it. The monitor shall be powered only with direct current. Non-ionizing magnetic radiation This electronic product is subject to disposal and recycling regulations that vary by country and region. Many countries prohibit the disposal of waste electronic equipment in standard waste receptacles. For more details, please ref…

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External photos of ORCHESTRA PLUS LINK FCC ID YSGKA351

OFFICIAL DOCUMENT Document Name / Nome documento / Nom du document U366A FF00932C - DMR-QMS Page 1/3 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 Etichetta / Label Product / Prodotto / Produit RF Programmer Applicable in: Clamart Original stored in: Clamart AM020291 Title / Titolo / Titre: ORCHESTRA PLUS LINK – RF Head label (on product) – USA/Canada Filed in Intraprod on : Name Function Signature Date Prepared by / Preparato / Préparé par M. LATTA Labelling designer Verified by / Verificato / Vérifié par E. ABHAMON R&D Rep Verified by / Verificato / Vérifié par G. ONNIS Marketing Rep Verified by / Verificato / Vérifié par C. PATHIRAGE RA Rep Approved by / Approvato / Approuvé par E. VINCENT Commercial QA Rep Electronic distribution, certified conforming to the signed and approved original OFFICIAL DOCUMENT Document Name / Nome documento / Nom du document U366A FF00932C - DMR-QMS Page 2/3 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. N. Change / Modifica / Changement Release date / Data di diffusione / Diffusion date A AM020291 Creation Electronic distribution, certified conforming to the signed and approved original OFFICIAL DOCUMENT Document Name / Nome documento / Nom du document U366A FF00932C - DMR-QMS Page 3/3 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. Label drawing & information Label: 36 mm x 51 mm REF: KA351 - For part number coding, refer to REQ1625 UDI = (01)+GTIN+(21)+SN printed in barcode 128 and alphanumerically GTIN = 08031527014210 SN: For serial number definition, refer to PG00428. Electronic distribution, certified conforming to the signed and approved original

ex : 2.66
#0.05 FF00892A 176 106 24 54.4 This document is SORIN's property. It can not be copied or forwarded without prior agreement of SORIN group. A 11/04/14 BCDEFG MATERIAL : / OVERALL TOLERANCES : / ANGLES : / REMARKS : For dimension modified, the text must be : Bold, Italic and in Red Color. x numbering for CRM use only. CARDIAC RHYTHM MANAGEMENT ASSEMBLY RF HEAD Mechanical Studies and Development (MSD) PREPARED BY: POUSSIN P. DATE: CHECKED BY: PAUTARD S. DATE: APPROVED BY: ABHAMON E. DATE: Scale / A3 G945 A 1/1 Weight = 450g with USB CABLE EXPLODED VIEW ECHELLE 3:4 G911 LEXAN G905 BOX 59006222 (x6) SCREW BOX 34903010 (x4) CAPS G906 BALLAST SCREW 1293.1100 (x6) LIGHT GUIDE G910 (x2) INTERNAL FOAM G926 USB CABLE G925 (x2) PAD G908 PCB EQUIPPED G912 LABEL Electronic copy of the original approved and signed document

Internal photos of ORCHESTRA PLUS LINK FCC ID YSGKA351

Product name:Orchestra plus link Manufacturer:SORIN FCC Id:YSGKA351 Prediction of MPE limit at a given distance Equation from page 18 of OET Bulletin 65, Edition 97-01 where:S = power density P = power input to the antenna G = power gain of the antenna in the direction of interest relative to an isotropic radiator R = distance to the center of radiation of the antenna Transmitter n°1 : 2421,1 MHz to 2458,9 MHz Maximum peak output power at the antenna terminal:18,35(dBm) Maximum peak output power at the antenna terminal:68,39116473(mW) Antenna gain(typical):-5,5(dBi) Maximum antenna gain:0,281838293(numeric) Prediction distance:20(cm) Prediction frequency:2400(MHz) MPE limit for uncontrolled exposure at prediction frequency:1(mW/cm^2) Power density at prediction frequency:0,003835(mW/cm^2) Maximum allowable antenna gain:18,66269855(dBi) Transmitter n°2: 402 to 405 MHz Maximum peak output power at the antenna terminal:-13,60(dBm) Maximum peak output power at the antenna terminal:0,043651583(mW) Antenna gain(typical):-4,9(dBi) Maximum antenna gain:0,323593657(numeric) Prediction distance:20(cm) Prediction frequency:403(MHz) MPE limit for uncontrolled exposure at prediction frequency:1(mW/cm^2) Power density at prediction frequency:0,000003(mW/cm^2) Maximum allowable antenna gain:50,61269855(dBi) Transmitter n°1 + Transmitter n°2: [Pd(1)/LPd(1)] + [Pd(2)/LPd(2)] =0,00384 <1 2 4R PG S p =

Test report N°: 127624-656122A Subject Radio spectrum Matters (ERM) tests according to standards: 47 CFR Part 15.247 & RSS-210, Issue 8 & RSS-Gen, Issue 3 Issued to SORIN Parc d'Affaires NOVEOS 4 avenue Réaumur 92143 Clamart cedex Apparatus under test  Product Orchestra plus link  Trade mark SORIN Group  Manufacturer SORIN Group  Model KA351  Serial number LA1403007  FCC ID YSGKA351  IC ID 10270A-KA351 Test date 2014/07/10 & 2014/09/05 Test location Fontenay Aux Roses Test performed by Arnaud FAYETTE & Laurent DENEUX Composition of document 54 pages Modification of the last version None Document issued on 2014/10/22 Written by : Approved by : Arnaud FAYETTE & Stéphane PHOUDIAH & Laurent DENEUX Philippe SISSOKO Tests operator Technical manager This document shall not be reproduced, except in full, without the written approval of the LCIE. This document contains results related only to the item tested. It does not imply the conformity of the whole production to the item tested .Unless otherwise specified; the decision of conformity takes into account the uncertainty of measures. This document does not anticipate any certification decision. TEST REPORT N°127824-856122A Page 2/54 SUMMARY 1. TEST PROGRAM ............................................................................................................................... 3 2. EQUIPMENT DESCRIPTION .............................................................................................................. 4 3. NUMBER OF HOPPING FREQUENCIES ........................................................................................... 9 4. CARRIER FREQUENCY SEPARATION ........................................................................................... 13 5. TIME OF OCCUPANCY .................................................................................................................... 17 6. OCCUPIED BANDWIDTH ................................................................................................................. 20 7. 20DB BANDWIDTH .......................................................................................................................... 24 8. PEAK OUTPUT POWER .................................................................................................................. 28 9. UNWANTED EMISSIONS INTO NON-RESTRICTED FREQUENCY BANDS ................................... 32 10. AC POWER LINE CONDUCTED EMISSIONS.................................................................................. 39 11. UNWANTED EMISSIONS INTO RESTRICTED FREQUENCY BANDS ............................................ 45 12. UNCERTAINTIES CHART ................................................................................................................ 54 TEST REPORT N°127824-856122A Page 3/54 1. TEST PROGRAM  References Standards: -47 CFR Part 15C -RSS-210 -RSS-Gen -ANSI C63.10  Radio requirement: Standard Section Test Description TEST RESULT - Comments CFR 47 § 15.247(a)(1) RSS-210 A8.4(2) Number of Hopping Frequencies PASS FAIL NA NP (Limited Program) CFR 47 § 15.247(a)(1) RSS-210 A8.1(b) Carrier Frequency Separation PASS FAIL NA NP (Limited Program) CFR 47 § 15.247(a)(1) RSS-210 A8.1(a) Time of Occupancy PASS FAIL NA NP (Limited Program) RSS-Gen § 4.6.1 Occupied Bandwidth PASS FAIL NA NP (Limited Program) CFR 47 § 15.247 (a) (1) RSS-210 § A8.1(a) 20dB Bandwidth PASS FAIL NA NP (Limited Program) CFR 47 § 15.247 (b)(1) RSS-210 § A8.1(b) Peak Output Power PASS FAIL NA NP (Limited Program) CFR 47 § 15.247 (d) RSS-210 § A8.5 Unwanted Emissions into Non-Restricted Frequency Bands PASS FAIL NA NP (Limited Program) CFR 47 § 15.207 RSS-Gen § 7.2.4 AC Power Line Conducted Emissions PASS FAIL NA NP (Limited Program) CFR 47 § 15.209 (a) CFR 47 § 15.205 (a) CFR 47 § 15.247 (d) RSS-210 § A8.5 Unwanted Emissions into Restricted Frequency Bands PASS FAIL NA NP (Limited Program) RSS-Gen § 4.10 Receiver Radiated emissions PASS FAIL NA (No Receiver) NP (Limited Program) This table is a summary of test report, see conclusion of each clause of this test report for detail. The product SORIN Group KA351, SN: LA1403007 is Compliant according to FCC 15.247, RSS-210, RSS-Gen standards. PASS: EUT complies with standard’s requirement FAIL: EUT does not comply with standard’s requirement NA: Not Applicable NP: Not Performed TEST REPORT N°127824-856122A Page 4/54 2. EQUIPMENT DESCRIPTION 2.1. GENERAL DESCRIPTION -The SORIN Group KA351 is part of the RF Programmer System. This system has been specially designed to program and interrogate Sorin Radio Frequency implantable medical devices. Sorin cardiac devices are equipped with a transceiver which receives clinical commands and sends clinical information and device parameters through the ORCHESTRA PLUS LINK Radio Frequency wireless technology. 2.2. HARDWARE & SOFTWARE IDENTIFICATION  Equipment under test (EUT): Photograph of EUT TEST REPORT N°127824-856122A Page 5/54  Auxiliary equipment (AE) used for testing: -Inductive Head -Orchestra Plus Photograph of AE TEST REPORT N°127824-856122A Page 6/54  Input/output: - USB  Software identification: -Software version: RF_FW_v1.5  Equipment information: - Modulation technology: FHSS modulation - Transmit operating mode: Multiples antenna without beam forming Multiples antenna with beam forming Single antenna: Equipment with 2 diversity antennas operating in switched mode by which at any moment in time only 1 antenna is used - Number of transmit chains: 1 2 3 4 Symmetrical Asymmetrical - Number of receiver chains: 1 2 3 4 - Antenna type: Integral External - Antenna Gain 1: -6dBi - Antenna Gain 2: -5.5dBi - Beamforming gain: Yes No - Type of the equipment: Stand-alone equipment Plug-in radio device Combined equipment - Test source voltage: Vnom: 120V/60Hz 5Vdc (USB) - Type of power source: Battery (Alkaline/Lithium-Ion/Lead acid/Other) Internal power supply External power supply (USB) Car Charger - Test sequence/test software used: See 2.2. Running …

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Test report N°: 127624-656122B Subject Radio spectrum Matters (ERM) tests according to standards: 47 CFR Part 95I & RSS-243 & RSS-Gen, Issue 3 Issued to SORIN Parc d'Affaires NOVEOS 4 avenue Réaumur 92143 Clamart cedex Apparatus under test  Product Orchestra plus link  Trade mark SORIN Group  Manufacturer SORIN Group  Model KA351  Serial number LA1403007E  FCC ID YSGKA351  IC ID 10270A-KA351 Test date 2014/07/10 to 2014/08/26 Test location Ecuelles Fontenay Aux Roses Test performed by Stéphane PHOUDIAH & Laurent DENEUX Composition of document 78 pages Modification of the last version None Document issued on 2014/10/22 Written by : Approved by : Stéphane PHOUDIAH & Laurent DENEUX Philippe SISSOKO Tests operator Technical manager This document shall not be reproduced, except in full, without the written approval of the LCIE. This document contains results related only to the item tested. It does not imply the conformity of the whole production to the item tested .Unless otherwise specified; the decision of conformity takes into account the uncertainty of measures. This document does not anticipate any certification decision. TEST REPORT N°127624-656122B Page 2/78 SUMMARY 1. TEST PROGRAM ............................................................................................................................... 3 2. EQUIPMENT DESCRIPTION .............................................................................................................. 4 3. FREQUENCY ERROR ........................................................................................................................ 9 4. EMISSION BANDWIDTH .................................................................................................................. 15 5. OCCUPIED BANDWIDTH ................................................................................................................. 21 6. TRANSMITTER OUTPUT POWER ................................................................................................... 26 7. AC CONDUCTED EMISSIONS ......................................................................................................... 29 8. TRANSMITTER UNWANTED EMISSIONS ....................................................................................... 34 9. RECEIVER SPURIOUS EMISSIONS ................................................................................................ 43 10. LBT THRESHOLD POWER LEVEL .................................................................................................. 49 11. MONITORING SYSTEM BANDWIDTH ............................................................................................. 55 12. MONITORING SYSTEM SCAN CYCLE TIME .................................................................................. 60 13. MINIMUM CHANNEL MONITORING PERIOD .................................................................................. 65 14. CHANNEL ACCESS ......................................................................................................................... 69 15. DISCONTINUATION OF MICS SESSION ......................................................................................... 74 16. UNCERTAINTIES CHART ................................................................................................................ 78 TEST REPORT N°127624-656122B Page 3/78 1. TEST PROGRAM  References Standards: -47 CFR FCC Part 95I -RSS-243 -RSS-Gen -FCC 15.207 -FCC 15.109  Requirements: Clause (FCC Part 95I) Test Description TEST RESULT - Comments FCC § 95.628(e) & RSS-243 § 5.3 – Frequency error PASS FAIL NA NP (Limited Program) FCC § 95.633(e) & RSS-243 § 5.1 – Emission bandwidth PASS FAIL NA NP (Limited Program) RSS-Gen § 4.6.1 – Occupied bandwidth PASS FAIL NA NP (Limited Program) FCC § 95.639(f) & RSS-243 § 5.4 – Transmitter output power PASS FAIL NA NP (Limited Program) FCC § 15.207(d) & RSS-Gen § 7.2.4 – AC conducted emissions PASS FAIL NA NP (Limited Program) FCC § 95.635(d) & RSS-243 § 5.5 – Transmitter unwanted emission PASS FAIL NA NP (Limited Program) FCC 15.109 & RSS-243 § 5.6 – Receiver spurious emissions PASS FAIL NA NP (Limited Program) FCC 95.628 (a)(3) & RSS-243 § 5.7.1 – LBT threshold power level PASS FAIL NA NP (Limited Program) FCC 95.628 (a)(1) & RSS-243 § 5.7.2 – Monitoring system bandwidth PASS FAIL NA NP (Limited Program) FCC 95.628 (a)(2) & RSS-243 § 5.7.3 –Monitoring system scan cycle time PASS FAIL NA NP (Limited Program) FCC 95.628 (a)(2) & RSS-243 § 5.7.4 –Minimum channel monitoring period PASS FAIL NA NP (Limited Program) FCC 95.628 (a)(4) & RSS-243 § 5.7.5 – Channel access PASS FAIL NA NP (Limited Program) FCC 95.628 (a)(4) & RSS-243 § 5.7.6 – Discontinuation of MICS session PASS FAIL NA NP (Limited Program) FCC 95.628 (a)(5) & RSS-243 § 5.7.7 – Use of pre-scanned alternative channel PASS FAIL NA (The system does not use the provision for use of a pre-scanned alternate channel) NP (Limited Program) This table is a summary of test report, see conclusion of each clause of this test report for detail. The product SORIN Group KA351, SN: LA1403007E is Compliant according to FCC part 95I & RSS-243 & RSS- Gen standards. PASS: EUT complies with standard’s requirement FAIL: EUT does not comply with standard’s requirement NA: Not Applicable NP: Not Performed TEST REPORT N°127624-656122B Page 4/78 2. EQUIPMENT DESCRIPTION 2.1. GENERAL DESCRIPTION -The SORIN Group KA351 is part of the RF Programmer System. This system has been specially designed to program and interrogate Sorin Radio Frequency implantable medical devices. Sorin cardiac devices are equipped with a transceiver which receives clinical commands and sends clinical information and device parameters through the ORCHESTRA PLUS LINK Radio Frequency wireless technology. 2.2. HARDWARE & SOFTWARE IDENTIFICATION DECLARED BY THE MANUFACTURER  Equipment under test (EUT): Photograph of EUT TEST REPORT N°127624-656122B Page 5/78  Auxiliary equipment (AE) used for t…

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FCC ID: YSGKA351 IC: 10270A-KA351 TEST SET UP PHOTOS SORIN KA351 FCC ID: YSGKA351 IC: 10270A-KA351 FCC ID: YSGKA351 IC: 10270A-KA351 FCC ID: YSGKA351 IC: 10270A-KA351 FCC ID: YSGKA351 IC: 10270A-KA351