Arthrex AR-3200-1018 Instructions For Use Manual Download Page 3 | Manualshive

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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 .................................................................................................................... 8

System Indicators .......................................................................................................................... 9

System Installation and Operation with Data Input Device ............................................................ 11

Installation .................................................................................................................................. 11

Components Shipped with System ............................................................................................. 12

System Use .................................................................................................................................. 13

Maintenance ................................................................................................................................... 14

Life Expectancy............................................................................................................................ 14

Periodic Maintenance ................................................................................................................. 14

Cleaning and Sterilizing ............................................................................................................... 14

Troubleshooting .......................................................................................................................... 14

Technical Information ..................................................................................................................... 15

APPENDIX [Detailed EMC Information] ......................................................................................... 17

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Summary of Contents for AR-3200-1018

Page 1: ...ries 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...

Page 2: ...anty 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 reference ...

Page 3: ...e 7 1 7 Unpacking and Inspecting the Device 8 1 8 Returning the Device 8 1 9 System Indicators 9 2 0 System Installation and Operation with Data Input Device 11 2 1 Installation 11 2 2 Components Shipped with System 12 2 3 System Use 13 3 0 Maintenance 14 3 1 Life Expectancy 14 3 2 Periodic Maintenance 14 3 3 Cleaning and Sterilizing 14 3 4 Troubleshooting 14 4 0 Technical Information 15 5 0 APPEN...

Page 4: ...e environmental conditions for use do not meet the standards or regulations defined in the accompanying documents 1 3 Warnings and Precautions The words WARNING PRECAUTION and NOTE carry special meanings and they should be read carefully WARNING The safety and or health of the patient user or a third party is at risk Comply with this warning to avoid injury to the patient user or third party PRECA...

Page 5: ...ot share an electrical outlet or grounding with life supporting or life sustaining equipment 11 If one or more mains powered units are connected simultaneously to one socket by the means of a distribution box the sum of the individual leakage currents may exceed the tolerated limits 12 For the protection of service personnel and for safety during transportation all devices and accessories that are...

Page 6: ... device is intended to be used by a trained medical professional 22 Biohazard waste such as explanted devices needles and contaminated surgical equipment should be safely disposed of in accordance with the institutions policy 23 Serious incidents should be reported to Arthrex Inc or an in country representative and to the health authority where the incident occurred 1 3 2 PRECAUTIONS 1 Surgeons ar...

Page 7: ...e mentioned requirements If in doubt consult your local representative or the technical department 16 Any person who connects external equipment to signal input and signal output ports or other connectors has formed a system and is therefore responsible for the system to comply with the requirements of IEC 60601 1 If in doubt contact a qualified Biomedical technician or your local representative 1...

Page 8: ...ces 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 ...

Page 9: ...ser Source Aperture Not for use in the Presence of Flammable Anesthetics Laser Radiation Fragile Attention Consult Accompanying Documents This Side Up Precaution of Warning Notice Keep Dry WEEE Waste Electronics and Electrical Equipment Symbol Regarding European Union End of Life of Product Humidity Limits for Storage and Transport Electrical Hazard Dangerous Voltages are Present Never attempt to ...

Page 10: ...tects human health and the environment For more information about where you can drop off your medical endoscopic video equipment at the end of its useful life for recycling please contact Arthrex Customer Service Department 1 6 Initial Use of the Device WARNINGS 1 The device is only completely isolated from the mains if the power plug is disconnected from the device s power inlet module Avoid posi...

Page 11: ... Return Authorization PRIOR to shipping your device for service Save ALL packaging materials they may be needed to verify any claims of damage by the shipper 1 8 Returning the Device If it becomes necessary to return the device always use the original packaging The manufacturer does not take responsibility for damage that has occurred during transportation if the damage was caused by inadequate tr...

Page 12: ... 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 Light guide must be oriented so that keys match port or light guide cannot be fully inserted 3 Power Indicator When the device is powered on this LED will illuminate ...

Page 13: ...Panel 1 Power Inlet Power connection for the power adapter supplied with the device Only the supplied power adapter should be plugged into this inlet 2 Laser Control Port Connection for laser control cable supplied with the device Only the supplied control cable should be plugged into this port ...

Page 14: ... standard grounded AC Mains outlet 100 240 V 50 60Hz 3 Place Synergy Laser Light Source on tower shelf or installed on equipment boom 4 Connect the DC cable of the Synergy Laser Light Source power adapter to the power input port on the back of the Synergy Laser Light Source Plug the supplied AC power cord into the power adapter and then plug the AC power cord into a standard grounded AC Mains outl...

Page 15: ...Source 2 2 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 N A Power adapter External power adapter class I Input 100 240 VAC 50 60 Hz 1 0 0 5A Output 12 V DC 3 34A 40W max ...

Page 16: ...n of the laser if it is not active The control cable between the Synergy Laser Light System and the SynergyID console is disconnected The SynergyID console is powered off Any camera head other than the Synergy NIR camera head AR 3210 0033 is connected to the SynergyID console The SynergyID LED light engine is powered off The SynergyID system fluorescence imaging mode is not active The SynergyID sy...

Page 17: ...l use and standard of care 3 2 Periodic Maintenance The product should be inspected prior to and after each use to ensure that there is no damage 3 3 Cleaning and Sterilizing Follow universal precautions for protective apparel when handling and cleaning contaminated instruments 3 3 1 Cleaning the Synergy Laser Light Source 1 Disconnect the device from power 2 Use a fresh CaviWipe or equivalent to ...

Page 18: ...EU Class Class IIa Health Canada Class Class II Safety Certifications Domestic Certification ANSI AAMI ES60601 1 2005 A1 2012 excluding Biocompatibility clause 11 7 Usability clauses 12 2 and 15 1 PEMS clause 14 and EMC clause 17 IEC 60825 1 2007 2nd edition and 2014 3rd edition Canadian Certification CAN CSA C22 2 No 60601 1 2014 excluding Biocompatibility clause 11 7 Usability clauses 12 2 and 1...

Page 19: ...ing to the mode of operation Continuous According to IEC 60825 1 2007 3 Ed 2 0 and IEC 60825 1 2014 5 Ed 3 0 laser optical output power 3R Specifications Parameter Parameter Value Power Requirements Rated Voltage 12 V DC 1 5 A Fuses No user serviceable fuses Laser Maximum Output Power 62 mW Laser Wavelength 785 nm Dimensions Approximately 9 0 W x 2 6 H x 6 0 D 22 9 cm W x 6 7 cm H x 15 3 cm D Tran...

Page 20: ...ervice technician for assistance NOTE The EMC tables and other guidelines that are included in the Instruction Manual provide information to the customer or user that is essential in determining the suitability of the Equipment or System for the Electro magnetic Environment of use and in managing the Electromagnetic Environment of use to permit the Equipment or System to perform its intended use w...

Page 21: ...ice should assure that it is used in such an environment Emissions test Compliance Electromagnetic Environment RF emissions CISPR 11 Group 1 The device uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A Harmonic emissions EN 61000 3 2 Class A Voltage fluctuat...

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Page 28: ...ex 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 49 89 909005 0 www arthrex de All rights reserved Printed in USA ...

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