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AR-3200-1018
DFU-0331 Revision 0
06/2020
Synergy Laser Light Source
Instructions for Use Manual
The Arthrex Synergy Laser Light Source User's Guide
provides important information for the safe operation of all
components of the Synergy Laser Light Source, including
accessories. Read this User's Guide thoroughly prior to
using this system and keep it in an easily accessible place
for use by all operating personnel. Read and follow all
safety warnings, cautions and precautions.
Arthrex, Inc.
1370 Creekside Blvd.
Naples, FL 34108, USA
+1 (800) 934-4404
www.arthrex.com
Technical Support
1-(800) 391-8599
EC
REP
Arthrex GmbH
Erwin-Hielscher-Strasse 9
81249 München, Germany
+49 89 909005-0
www.arthrex.de
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Table of Contents
Related Manuals for Arthrex AR-3200-1018
Summary of Contents for Arthrex AR-3200-1018
- Page 1 Synergy Laser Light Source Instructions for Use Manual The Arthrex Synergy Laser Light Source User’s Guide provides important information for the safe operation of all components of the Synergy Laser Light Source, including accessories. Read this User’s Guide thoroughly prior to using this system and keep it in an easily accessible place for use by all operating personnel.
- Page 2 This is not a warranty document. For all warranty information, including disclaimers, exclusions, terms, conditions, and related provisions, refer to the “Arthrex U.S. Product Warranty” section of the Arthrex, Inc. website, found at www.arthrex.com whose provisions are incorporated herein by...
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Page 3: Table Of Contents
Table of Contents Introduction ............................1 Intended Use ..........................1 Contraindications .......................... 1 Warnings and Precautions ......................1 Symbol Definitions ........................6 End of Life, Environmental Directives ................... 7 Initial Use of the Device ........................ 7 Unpacking and Inspecting the Device ................... 8 Returning the Device ........................ -
Page 4: Introduction
WARNING: The safety and/or health manual before attempting to operate, clean, of the patient, user, or a third party is and/or sterilize the Arthrex Synergy Laser at risk. Comply with this warning to Light Source (AR-3200-1018) and avoid injury to the patient, user, or accessories. - Page 5 4. For the protection of the patient it is sum of the individual leakage currents essential that the Synergy Laser Light may exceed the tolerated limits. Source to Synergy endoscopic video 12. For the protection of service personnel, system interconnection is complete and and for safety during transportation, all the Synergy endoscopic video system is...
- Page 6 Arthrex representative for an onsite or light guide connector on the patient’s demonstration. skin, on flammable materials or on heat 2. Only use the device with Arthrex compatible equipment listed in Section 2.2. sensitive materials. • Turn the Synergy light source off when 3.
- Page 7 4. This device should only be used in ports or other connectors has formed a compliance with its intended use. system and is therefore responsible for the system to comply with the requirements of 6. Prior to each use, the device must be IEC 60601-1.
- Page 8 19. In CE accepting Countries: Procedures carried out using these devices may be used on the general population. 20. In CE accepting Countries: The clinical benefits associated with the use of these devices outweigh the known clinical risks. 21. In CE accepting Countries: There are no unacceptable residual risks or uncertainties associated with the clinical use of these devices.
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Page 9: Symbol Definitions
Symbol Definitions All of the symbols used on the labeling along with the title, description and standard designation number may be found on our website at www.arthrex.com/symbolsglossary. Safety Sign Caution: Federal Law Restricts Follow Operating this device to Instructions sale by or on the order of a Physician. -
Page 10: End Of Life, Environmental Directives
Video System must meet the endoscopic video equipment at the end of its requirements of the following useful life for recycling, please contact Arthrex specifications: Customer Service Department. DFU-0331r0_fmt_en-US Page 7 of 25... -
Page 11: Unpacking And Inspecting The Device
Please make sure that all 7. All final Endoscopic Video Systems must required information has been supplied. Call meet the requirements of IEC 60601-1. Arthrex for an RMA Number for the device return for service. • Owner’s Name CAUTION: Do not install the device •... -
Page 12: System Indicators
Figure 1- Synergy Laser Light Source Front Panel [AR-3200-1018] System Indicators 1.9.1 Synergy Laser Light Source Front Panel 1. Active Laser Indicator- When the laser is active this LED will illuminate. 2. Light Guide Port- Port for Light Guide insertion NOTE: Port is keyed to match Arthrex light guide. - Page 13 Figure 2- Synergy Laser Light Source Rear Panel 1.9.2 Rear Panel 2. Laser Control Port-Connection for laser 1. Power Inlet-Power connection for the power control cable supplied with the device. Only the adapter supplied with the device. Only the supplied control cable should be plugged into supplied power adapter should be plugged into this port.
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Page 14: System Installation And Operation With Data Input Device
System Installation 2. Plug the AC power cord into the Synergy power inlet module and a standard and Operation with grounded AC Mains outlet (100-240 V˜, 50- 60Hz). Data Input Device 3. Place Synergy Laser Light Source on tower shelf or installed on equipment boom. 4. -
Page 15: Components Shipped With System
Figure 3- Synergy Typical Interconnect Diagram Including Synergy Laser Light Source Components Shipped with System The following components are shipped with the Synergy Laser Light Source. Component Description Details Synergy Laser Light Source Laser light source, main unit Input:100-240 VAC, 50/60 Hz, 1.0-0.5A Power adapter External power adapter, class I... -
Page 16: System Use
96 in. cordage: SJT, 18AWG/3C, Unshielded, Temp rating 60°C (140°F) Rating: 125 V, 10A, Jacket North American hospital grade North American AC power cord Colour: Gray power cord Plug: NEMA 5-15P Hospital Grade (Clear) Connector: IEC 60320 C- 13 (Gray Rating: 10A/250V AC Temperature rating: 60°C (140°F) -
Page 17: Maintenance
It is important to visually inspect the device before each use. Your authorized Arthrex service department is the most knowledgeable about the device and will provide competent and efficient service. Any services and/or repairs done by any unauthorized repair facility may result in reduced performance of the instruments or instrument failure. -
Page 18: Technical Information
Symptom Possible Cause Corrective Action • Verify control cable connected • Plug control cable securely into both between Synergy console Synergy console and laser light and laser light source. source. • Suspect control cable. • Replace control cable. Laser does not activate. - Page 19 Safety Certification Marking CE Marking CE Marking for MDD 93/42/EEC, RoHS 2011/65/EU Safety, Classifications Classification of Equipment Parameter Value According to protection against electric shock. Class I [Grounded] According to Degree of protection against Ordinary [IPX-0] (no protection) harmful ingress of water. According to the degree of safety in the Equipment is NOT suitable for use in the presence of Flammable Anesthetics...
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Page 20: Appendix [Detailed Emc Information]
APPENDIX [Detailed disturbing other Equipment and Systems or non-medical electrical equipment. EMC Information] NOTE: Medical Electrical Equipment needs special precautions regarding EMC and needs DETAILED EMC INFORMATION to be installed and put into service according to the EMC information provided in the NOTE: CE marked equipment has been tested Accompanying Documents. - Page 21 Guidance and manufacturer’s declaration – electromagnetic emissions The Synergy Laser Light Source device is intended for use in the electromagnetic environment specified below. The customer or the user the device should assure that it is used in such an environment. Emissions test Compliance Electromagnetic Environment...
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- Page 28 Naples, FL 34108-1945, USA Customer Service +1 (800) 934-4404 Arthrex, Inc. Toll-Free Technical Support: 1-(800) 391-8599 Monday through Friday, 8:00 AM – 8:00 PM ET Arthrex, Inc. 1370 Creekside Blvd. Naples, FL 34108, USA +1 (800) 934-4404 www.arthrex.com Arthrex GmbH Erwin-Hielscher-Strasse 9 81249 München, Germany...
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