ORCHESTRA PLUS LINK USER MANUAL KA 351
TABLE OF CONTENTS 1. List of symbols ..........................................................................................................................................................................................2 2. Symbols used in this manual ...................................................................................................................................................................3 3. Introduction ..........................................................................
1. LIST OF SYMBOLS 1. LIST OF SYMBOLS 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.
2. SYMBOLS USED IN THIS MANUAL 2. SYMBOLS USED IN THIS MANUAL This icon is used to call your attention to a particularly important point. This icon alerts you to a hazard that may result in equipment damage or personal injury. Carefully read the instructions provided with this icon. ABOUT THIS MANUAL If you have technical or usage questions that are not covered in this manual or you want more in-depth information, please contact your sales representative.
3. INTRODUCTION 3. INTRODUCTION The ORCHESTRA PLUS LINK 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.
4. USER PROFILE 4. USER PROFILE Any person who followed the required training based on the local regulation. Training completion and effectiveness are under his/her medical supervisor’s responsibility.
5. INDICATION 5. INDICATION The ORCHESTRA PLUS LINK is designed for use with: - Sorin Radio Frequency implantable medical devices, - Sorin Orchestra Plus programmer equipped with a Sorin inductive programming head.
6. WARNINGS AND PRECAUTIONS 6. WARNINGS AND PRECAUTIONS 6.1 SAFETY PRECAUTIONS Alteration – Your ORCHESTRA PLUS LINK and supplied accessories shall not be modified, altered, or changed in any way without signed written permission from Sorin. Unauthorized modification may void the equipment authorization from the certified body (compliance to standards) and compromise system performance. Use only Sorin supplied accessories.
7. PACKAGE CONTENTS 7. PACKAGE CONTENTS Inside the box you will find ORCHESTRA PLUS LINK and its user manual (CD-Rom). Do not use any other parts than those supplied with the ORCHESTRA PLUS LINK.
8. DESCRIPTION 8.
9. USING ORCHESTRA PLUS LINK 9. USING ORCHESTRA PLUS LINK 9.1 SETTING-UP ORCHESTRA PLUS LINK In order to setup ORCHESTRA PLUS LINK, follow the instructions below. Step Operation 1 Install & switch on Orchestra Plus programmer (refer to Orchestra Plus user manual) 2 Take ORCHESTRA PLUS LINK out of the box. 3 Place your ORCHESTRA PLUS LINK on a stable and flat surface, (on a trolley, table or the patient’s bed) as close as possible to the patient.
9. USING ORCHESTRA PLUS LINK Quitting the programming session reduces battery consumption and optimizes device longevity. 9.3 ENSURING STABLE RF COMMUNICATION For stable RF communication between ORCHESTRA PLUS LINK and the implantable medical device, it is recommended to position ORCHESTRA PLUS LINK in order to light at least 4 LEDs. It is highly recommended to obtain stable communication before performing device tests such as pacing and defibrillation threshold tests.
10. ORCHESTRA PLUS LINK BASIC CARE 10. ORCHESTRA PLUS LINK BASIC CARE Protect the ORCHESTRA PLUS LINK from splashes. To clean it, please only use a soft dry cloth. Any other cleaning method could damage the ORCHESTRA PLUS LINK. Do not use any kind of detergents even dry ones. Do not sterilize.
11. MAINTENANCE AND RECYCLING 11. MAINTENANCE AND RECYCLING 11.1. COMPATIBILITY For more information about implant Radio Frequency wireless programming compatibility with ORCHESTRA PLUS LINK, please refer to the implant user manual. The ORCHESTRA PLUS LINK requires neither maintenance, nor calibration (periodical electrical test). As with all electronic devices, recycling the ORCHESTRA PLUS LINK is mandatory, therefore please return it to Sorin if no longer used.
12. TROUBLESHOOTING 12. TROUBLESHOOTING Start-up problems If the ORCHESTRA PLUS LINK functioning status LED is not green, verify USB connection with Orchestra Plus. If the problem persists, call your sales representative.
13. TECHNICAL SPECIFICATIONS 13.
14. DECLARATION OF CONFORMITY 14. DECLARATION OF CONFORMITY Sorin declares that this device conforms to the following Product Specifications: Safety - IEC 60601-1: 2005 (Ed. 3) - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. EMC - IEC 60601-1-2: 2012 (Ed. 3) - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and Tests.
14. DECLARATION OF CONFORMITY The FCC product ID is YSGKA351. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.
14. DECLARATION OF CONFORMITY This class B digital apparatus meets all requirements of the Canadian Interference- causing equipment regulations. This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.
15. GUIDANCE AND MANUFACTURER’S DECLARATION 15. GUIDANCE AND MANUFACTURER’S DECLARATION 15.1 ELECTROMAGNETIC EMISSIONS The ORCHESTRA PLUS LINK is intended for use in the electromagnetic environment specified below. The user of the ORCHESTRA PLUS LINK should ensure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions CISPR 11 Group 1 The ORCHESTRA PLUS LINK uses RF energy only for its internal function.
15. GUIDANCE AND MANUFACTURER’S DECLARATION Recommended separation distance: 3 Vrms Conducted RF 150 kHz 80 MHz IEC 61000-4-6 d 1.2 P to 3 V 3 V/m Radiated RF 80 MHz 2.5 GHz IEC 61000-4-3 to 3 V/m d 1.2 P 80 to 800 MHz d 2.3 P 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).
16. TECHNICAL ASSISTANCE 16. TECHNICAL ASSISTANCE For any assistance you may need or question you may have about your ORCHESTRA PLUS LINK, please call your sales representative.
CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN 2014-10 U386A Manufactured in Italy by Sorin Group Italia S.r.l. Via Crescentino s.n. 13040 Saluggia (VC) - Italy Tel: +39 0161 487095 Fax: +39 0161 487524 © 2014 Sorin CRM SAS Distributed by Sorin CRM USA, Inc. 14401 West 65th Way Arvada,CO 80004 - USA www.sorin.
