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Related Manuals for sorin ORCHESTRA PLUS LINK KA 351
Summary of Contents for sorin ORCHESTRA PLUS LINK KA 351
- Page 1 ORCHESTRA PLUS LINK USER MANUAL KA 351...
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Page 3: Table Of Contents
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 Safety Precautions ..................................7 Precautions for safe operation ..............................7 7. -
Page 4: List Of Symbols
Temperature limits for storage and transportation Humidity limits for storage and transportation Pressure limits for storage and transportation Sorin Reference of the ORCHESTRA PLUS LINK USB Type A Power supply connector to Orchestra Plus FCC ID : YSGKA351 IC ID: 10270A-KA351... -
Page 5: Symbols Used In This Manual
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. SORIN – ORCHESTRA PLUS LINK – U386A... -
Page 6: Introduction
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. -
Page 7: User Profile
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. SORIN – ORCHESTRA PLUS LINK – U386A... -
Page 8: Indication
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. SORIN - ORCHESTRA PLUS LINK – U386A... -
Page 9: Warnings And Precautions
Power supply – The ORCHESTRA PLUS LINK shall be connected exclusively to one of Sorin Orchestra Plus USB ports. Refer to Orchestra Plus user manual for location of ports E & C (dual ports). -
Page 10: Package Contents
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. SORIN - ORCHESTRA PLUS LINK – U386A... -
Page 11: Description
8. DESCRIPTION 8. DESCRIPTION A/ Functioning status LED B/ RF link indicator LED C/ RF signal strength 5 LEDs D/ USB cable SORIN – ORCHESTRA PLUS LINK – U386A... -
Page 12: Using Orchestra Plus Link
Quit the programming session before the patient leaves the operating room or follow- RF programming communication will be in any case automatically disabled after a time of inactivity (RF still active for Remote Monitoring). SORIN - ORCHESTRA PLUS LINK – U386A... -
Page 13: Ensuring Stable Rf Communication
Orchestra Plus. (Orchestra Plus shall be on.) During the update the functioning status LED is green and the RF signal strength LEDs indicate the action in-progress by blinking sequentially. SORIN – ORCHESTRA PLUS LINK – U386A... -
Page 14: 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. SORIN - ORCHESTRA PLUS LINK – U386A... -
Page 15: Maintenance And Recycling
Sorin if no longer used. Please contact your sales representative for more information on the collection procedure. Sorin will be in charge of collecting and recycling it in compliance with European Directive 2002/96/CEE. SORIN – ORCHESTRA PLUS LINK – U386A... -
Page 16: Troubleshooting
Re-position (5 - 10 cm) or rotate the ORCHESTRA PLUS LINK Move the ORCHESTRA PLUS LINK closer to the implantable medical device If none of the above works, switch to inductive telemetry SORIN - ORCHESTRA PLUS LINK – U386A... -
Page 17: Technical Specifications
MedRadio: uses Listen Before Talk algorithm, EIRP = 25 µW max, FSK modulation. Receiver 402-405 MHz (MedRadio) frequency The ORCHESTRA PLUS LINK may be disturbed by other equipment, even if said equipment complies with CISPR emission requirements. SORIN – ORCHESTRA PLUS LINK – U386A... -
Page 18: Declaration Of Conformity
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. - Page 19 FCC Interference Statement 47 CFR Section 15.21 - No Unauthorized Modifications CAUTION: This equipment may not be modified, altered, or changed in any way without signed written permission from SORIN. Unauthorized modification may void the equipment authorization from the FCC and will void the SORIN warranty.
- Page 20 400,150-406,000 MHz, et il doit accepter tout brouillage reçu, y compris le brouillage pouvant entraîner un mauvais fonctionnement du dispositif. SORIN - ORCHESTRA PLUS LINK – U386A...
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Page 21: Guidance And Manufacturer's Declaration
Portable and mobile RF communications equipment should be used no closer to the ORCHESTRA PLUS LINK, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. SORIN – ORCHESTRA PLUS LINK – U386A... -
Page 22: Recommended Separation Distances Between Portable And Mobile Rf Communications Equipment And The Orchestra Plus Link
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. SORIN - ORCHESTRA PLUS LINK – U386A... -
Page 23: Technical Assistance
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. Last revision date of this manual: 2014-10 SORIN – ORCHESTRA PLUS LINK – U386A... - Page 24 Sorin Group Italia S.r.l. Sorin CRM USA, Inc. Via Crescentino s.n. 14401 West 65th Way 13040 Saluggia (VC) - Italy Arvada,CO 80004 - USA Tel: +39 0161 487095 www.sorin.com Fax: +39 0161 487524 © 2014 Sorin CRM SAS...
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