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FIBER OPTIC CABLES User Manual ENGLISH

1. FIBER OPTIC CABLES User Manual ENGLISH 99 Hartwell Street West Boylston MA 01583 USA Tel 1 508 835 9700 US Toll Free 800 325 8966 Fax 1 508 835 9976 Website http www integra surgical com E mail custsvcluxtec integra surgical com a D e EE ar hie a i gt EOD Gi e FIBER OPTIC CABLES TABLE OF CONTENTS PAGE DESCRIPTION Indication for Use Symbols General Warnings Precautions Cable Care 7 Maintenance Repair and Return Information NN DO WwW HR HR W N Limited Express Warranty EoD GE 1e7 FIBER OPTIC CABLES INDICATION FOR USE This fiber optic cable is designed to deliver illumination from a high intensity light source to a surgical headlight or surgical instrument for surgical site illumination either standard or minimally invasive It is compatible for use with light sources made with the following Xenon with lamp power rating of up to 300 Watts Halogen with lamp power rating of up to 250 Watts or Metal Halide with lamp power rating of up to 100 Watts Any light source used with this cable should have a minimum of 90 IR filtering to prevent cable damage during use FIBER OPTIC CABLES CD GE 1e TABLE OF SYMBOLS Found on a medical grade light source other illumination related equipment fiber optic cables and corresponding packaging Attention Consult Accompanying Documents Fuse Type CF Equipment gt amp a a eo Cau
2. Sterilant Concentration Place a Peracetic acid Chemical Indicator and cable in tray and secure lid Place tray into the STERIS SYSTEM I Exposure Time 12 0 Minutes CIDEX PLUS 28 day Solution Clean and dry the cable taking care not to scratch any of the optical surfaces Follow the manufacturer s instructions to prepare the CIDEX PLUS Sterilant to the manufacturer s recommended effective concentration Use the CIDEX PLUS solution test strip to verify effectiveness of the sterilant Submerge Cable in CIDEX PLUS Allow thorough soak for 10 hours at 68 77 F 20 25 C Dry per manufacturer s recommendations 6 UltraLite and Sweatband headlight cables can be identified by the curved lens at the light source end CD GE e FIBER OPTIC CABLES Sterilization UltraLite headlight cables The UltraLite fiber optic cable has not been specifically designed to withstand sterilization There is a lens assembly at the light source end which is not sealed and could allow moisture to penetrate behind the lensing Meticulous care should be taken to avoid cable contact with sharp or pointed objects Ensure your autoclave is operating correctly for effective sterilization Consult your autoclave manual for specific instructions conditions and exposure periods The pressure differential which occurs during steam autoclaving may cause small bubbles in the tubing These bubbles will not affect the fiber optic cable and
3. will dissipate in time Following sterilization of your fiber optic cable allow it to cool very slowly to room temperature DO NOT immerse or rinse in a cold liquid as this will cause fiber breakage and extensive light transmitting losses REPAIR AND RETURN INFORMATION Indications for replacement When a fiber optic cable shows 30 loss of light transmission of its fibers the cable needs to be replaced This can be determined while holding both ends of the cable point one cable end toward a light while looking at the other end DO NOT PERFORM THIS CHECK WHILE THE FIBER OPTIC CABLE IS ATTACHED TO AN OPERATING LIGHT SOURCE The brilliant light output can cause severe eye discomfort 2 When there is separation of the cable components that can be seen with a visual inspection such as strain relief and sheath or endfittings 3 When a cable has been excessively stretched or cut Contact your local LUXTEC representative to order replacement cables or call Luxtec customer Service Department at 800 325 8966 USA amp Canada or at 1 508 835 9700 ATTENTION OPERATING ROOM PERSONNEL We require that you clean and sterilize if compatible all equipment before returning for repair If equipment is received in an unsanitary condition an additional cleaning fee will be charged including those pieces repaired under our warranty Please note on shipping packaging if contents have not or cannot be sterilized LIMITED EXPRESS WARRANTY L
4. IMPLIED WARRANTIES INCLUDING BUT NOT LIMITED TO ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND LUXTECNESS FOR A PARTICULAR PURPOSE IN NO EVENT SHALL LUXTEC BE LIABLE TO ANY PARTY FOR INDIRECT INCIDENTAL OR CONSEQUENTIAL DAMAGES WHETHER RELATED TO THIS OR ANY OTHER CLAIM REGARDLESS OF ANY KNOWLEDGE OF LUXTEC OF SUCH POTENTIAL DAMAGES UltraLite and Sweatband headlight cables can be identified by the curved lens at the light source end 7 CD Gi e wee te 2 INTEGRA Surgical www ntegra Surgical com The Integra wave logo Integra Surgical UltraLite and Luxtec are trademarks of Integra LifeSciences Corporation Copyright 2010 Integra LifeSciences Corporation All rights reserved THE INSTRUMENT PEOPLE eenaa Ao hs 12 09
5. UXTEC warrants that the fiber optic cable furnished hereunder shall be free from defects in material and workmanship under normal use and service for a period of eighteen 18 months from the date of shipment from LUXTEC excluding fiber breakage LUXTEC Premium UltraLite headlight cables feature a lifetime warranty against browning LUXTEC s sole and exclusive liability under this warranty shall be at LUXTEC s option either to repair or replace any component of the cable which fails during the warranty period due to any defect in workmanship or material FO B factory if 1 customer promptly reports such defect to LUXTEC in writing 2 if requested by LUXTEC customer returns equipment to LUXTEC with shipping charges pre paid and 3 upon inspection LUXTEC finds the cable to be defective This warranty is contingent upon normal and proper use of the cable and does not cover fiber breakage or a cable which has been modified without written approval of LUXTEC subjected to unusual physical stress or damaged during shipment This warranty is nontransferable unless authorized in writing by LUXTEC If LUXTEC is unable to remedy any defect in the cable as required by the foregoing warranties LUXTEC s liability shall not in any event exceed the purchase price received hereunder by LUXTEC for the equipment THE WARRANTIES SET FORTH HEREIN ARE IN LIEU OF ANY OTHER REPRESENTATIONS OR WARRANTIES LUXTEC DISCLAIMS AND CUSTOMER WAIVES ALL OTHER EXPRESS OR
6. and could subsequently leak out and cause tissue reactions Rinse thoroughly with distilled water taking care to rinse the face of glass fiber at both ends of the cable Cleaning UltraLite headlight cables Luxtec suggests the use of alcohol wipes to clean the UltraLite and Sweatband headlight cables Disinfecting other than UltraLite headlight cables Cables may be soaked briefly in disinfecting solutions without damage Refer to the manufacturer s time specifications however avoid soaking cables for more than 10 minutes Disinfecting UltraLite headlight cables Soaking the UltraLite and Sweatband headlight cables in any sterilizing disinfectant should be avoided There is a lens assembly at the light source end which is not sealed and could allow moisture to penetrate behind the lens Sterilization other than UltraLite headlight cables RECOMMENDED STERILIZATION METHODS STEAM Hospital Steam Sterilizer compliant to AAMI ST8 Place clean and dry cables in a steam sterilization self seal pouch or compatible container Temperature 270 F 132 C Exposure Time 4 0 Minutes Drying Time 20 0 Minutes ETO ethylene oxide Place clean and dry cables in a ETO self seal pouch or compatible container ETO concentration 100 Exposure time 60 minutes Temperature 131 F 55 C Aeration 8 hours minimum STERIS SYSTEM Place clean and dry cables ina self seal pouch or compatible container Steris 20
7. he high brightness and the light output of the fiber optic cable can cause burns FIRE HAZARD DO NOT DRAPE OR COVER THE LIGHT SOURCE OR THE FIBER OPTIC CABLE WHILE IT IS OPERATING DO NOT PLACE THE CABLE END FITTING ON A DRAPE WHILE IT IS OPERATING PRECAUTIONS e Take precautions to verify that the fiber optic cable is appropriately suited for the light source Xenon and other high illumination light sources require premium fiber optic cables in order to achieve optimal performance and prevent damage to the fibers thereby diminishing the quality of the light output or the useful life of fiber optic cable e Take precautions not to touch or disconnect the cable end fitting from the turret until the light source has been shut down for a period of time and allowed to cool The cable end fitting will remain hot immediately following shut down which can cause burns e Take precautions to not place and rest a hot cable end fitting and or head light on a patient or allow the system to come in contact with un protected hands or tissue The entire system should be allowed to cool following use Failure to do so can cause burns and or tissue damage CD GE 1e FIBER OPTIC CABLES CABLE CARE Fiber optic cables are fine high quality optical instruments You can prolong the useful life by following a few guidelines e Avoid stretching your cable forming configurations involving sharp angles or kinks or contact with sharp or p
8. ointed objects The internal light fibers are made of glass a material that breaks under stress Fiber breakage will result in diminished light output e Utilize the gown clips if provided to keep the headlight cable secured to the surgeon s gown for greater comfort and maneuverability This does not apply to instrument cables e Do not use your fiber optic cable with any alterations to its original design or fabrication e Bundle size aperture of the fiber optic cable should be matched to the aperture of the instrument to obtain maximum light output NOTE A larger aperture fiber optic cable will not increase light output of a smaller aperture instrument e Keep the optical faces from contacting the floor or other hard surfaces The resulting scratches will diminish light output Store the cables in sterilization trays for additional protection e Any inadvertent cut or puncture to the outer sheath will render the cable unsafe It should be taken out of service immediately LUNTEC FIBER OPTIC CABLES MAINTENANCE Follow all applicable bloodborne pathogen procedures as indicated by OSHA and or your hospital requirements when cleaning disinfecting and sterilizing instruments and accessories Cleaning other than UltraLite headlight cables Lukewarm water with mild detergent is recommended to remove all blood and debris Do not use synthetic detergents or oil based soap as these chemicals may be absorbed into the cable
9. tion High Voltage oe Equipotentiality Protective Earth Type BF Equipment High Temperature On Off p Brightness Stand by Motor System Status Display ge Fan System CE Do Not Dispose Listed by ETL Push Listed by CSA us co isted by Hours Part Number Over Temperature LOT Batch Code Intensity Serial Number 2 Lamp Keep dry Authorized Representative in the European Community Manufacturer LUNTEC FIBER OPTIC CABLES GENERAL WARNINGS e The user should carefully study this manual before making any attempt to use the product clinically Instructions should be followed specifically with special attention given to warnings and cleaning instructions This manual should also be available to the surgical team during a procedure e Follow the instructions in the operating manuals of other manufacturers equipment when they are used in conjunction with this product e Before every procedure carefully inspect the fiber optic cable to ensure it has been properly maintained cleaned and sterilized if compatible and that it is fully functional e Care should be taken to follow the maintenance and cleaning instructions e Excessive bending of the cable should be avoided e Use care not to point the cable directly at the eye while in operation The brilliant light output can cause severe eye discomfort e Light sources use high intensity lamps which produce heat as well as brilliant light T

FIBER OPTIC CABLES User Manual ENGLISH

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