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ULTRALITE® PRO HEADLIGHT Operation and Service Manual

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1. with lens Luxtec warrants that the equipment manufactured by tissue available at any camera store Follow the Luxtec shall be free from defects in material and package directions Follow all applicable bloodborne workmanship under normal use and service for a pathogen procedures as indicated by OSHA period of three 3 years except the cable from the and or your hospital requirements when cleaning and date of shipment from Luxtec Luxtec s sole and disinfecting exclusive liability under warranty shall be at Luxtec s option either to repair or replace any component WARNING which fails during the warranty period due to any DO NOT soak the UltraLite Pro cable in any defect in workmanship or material FO B factory if sterilization solution Customer promptly reports such defect to Luxtec CLEANING HEADBAND in writing The headband may be cleaned by an alcohol 2 If requested by Luxtec customer returns equipment wipedown or washed with lukewarm water and mild to Luxtec with shipping charges and detergent 3 Upon inspection Luxtec finds the equipment to be defective CLEANING FIBER OPTIC CABLE Luxtec suggests that the use of alcohol wipes to clean This warranty is contingent upon normal and proper the headlight cables use of the equipment It does not cover equipment modified without the written approval of Luxtec WARNING subjected to unusual physical or electrical stress DO NOT soak the UltraLite Pro cable in any or damaged duri
2. D Gi e F a_AMWTEGRA Surgical www Integra Surgical com The Integra wave logo Integra Surgical are trademarks of Integra LifeSciences Corporation Luxtec and UltraLite are registered trademarks of Integra LifeSciences Corporation and its subsidiaries Copyright 2010 Integra LifeSciences Corporation All rights reserved THE INSTRUMENT PEOPLE P N 850532 Rev C LUSXXTEC OMNITRACT eae 4E PADGETT REDMOND 01 10
3. MUD E e LUNTEC ULTRALITE PRO HEADLIGHT Operation and Service Manual ENGLISH 99 Hartwell Street West Boylston MA 01583 USA Tel 1 508 835 9700 US Toll Free 1 800 325 8966 Fax 1 508 835 9976 Website http www integra surgical com E mail custsvcluxtec integra surgical com A INTEGRA Surgical ULTRALITE9 PRO HEADLIGHT SYSTEM MOD Gi e TABLE OF CONTENTS PAGE 1 Oo v o OON YN KA WN O DESCRIPTION Indication For Use Symbols General Warnings Precautions Assembly Adjustments Replacement Parts Care and Maintenance Warranty Return Policy MOD MEZ ULTRALITE PRO HEADLIGHT SYSTEM INDICATION FOR USE This fiber optic headlight system is designed to deliver illumination from a high intensity light source for surgical site illumination While the cable light source end fittings are compatible with all light sources brightness and spot quality vary with specific types of light sources The UltraLite Pro systems perform best with Luxtec Xenon light sources MOD EZIO ULTRALITE9 PRO HEADLIGHT SYSTEM SYMBOLS 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 Caution High Voltage Equipotentiality Protective Earth On Off Stand by System Status Display System Do Not Dispose Push Hours Ove
4. SSEMBLY ASSEMBLY OF THE ULTRALITE PRO HEADLIGHT SYSTEM Next open the headlight assembly fully by pulling the central unit Fig 7 completely open and opening the Place the headlight on your head The occipital basket should be aligned Fig 10 as shown Fig 10 headlight from front to back until it fits snugly Adjust the pad front to back Fig 12 for a more comfortable fit Fig 12 The headlight should then be adjusted circumferentially using the ratchet knob at the rear as shown Fig 13 The UltraLite Pro headlight is now ready for use The headlight system comes with two gown clips to Fig 13 da relieve the weight of the fiber optic cable from the head One clip should be attached to the surgical gown or scrubs at or just below shoulder level Fig 14 Be sure to leave enough slack in the cable to allow for iw Fig 14 y E freedom of head movement If the surgeon needs to detach the cable from the light source the second gown clip is used to attach the cable to the gown or scrubs to eliminate the risk of dropping the cable The spot size of the light may be adjusted from 20 100mm 0 8 4 in based on a 46cm 18 in working distance by adjusting the iris Fig 15 Fig 15 The module can be removed from the headband if ULTRALITE9 PRO HEADLIGHT SYSTEM MOD EZIO needed by placing a small flathead screwdriver in the slot above the
5. be taken to follow the maintenance and cleaning instructions PRECAUTIONS Excessive bending of the cable should be avoided Take precautions to verify that the fiber optic cable Use care not to point the headlight directly at the is appropriately suited for the light source Xenon eye while in operation The brilliant light output can and other high illumination light sources require cause severe eye discomfort premium fiber optic cables in order to achieve optimal performance and prevent damage to the FIRE HAZARD DO NOT DRAPE OR fibers thereby diminishing the quality of the light COVER THE LIGHT SOURCE WHILE IT IS output or the useful life of fiber optic cable OPERATING DO NOT PLACE THE FIBER OPTIC CABLE ON A DRAPE WHILE THE e Tak i h or di h LIGHT SOURCE IS OPERATING ake 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 headlight 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 ASSEMBLY OF THE ULTRALITE PRO HEADLIGHT SYSTEM The UltraLite Pro Headlight system consists of a headba
6. module in the headband Fig 16 and pushing the module out Be sure to remove the fiber optic cable from the module first Fig 16 CAUTION To plug or unplug the fiber optic cable from the light source it is recommended that the light source power be turned off Be sure to hold the strain reliever near the end of the cable This part of the cable is reinforced to prevent damage to the glass fibers inside and to prevent burns ADJUSTMENTS Once the headlight module and fiber optic cable are attached to the headband the headlight assembly is ready to use The headlight module can be adjusted vertically while wearing the headlight system by grasping the module and aligning the light spot to a comfortable working position Luxtec manufactures its headlights to the highest quality standards Each one is tested thoroughly before leaving the factory to ensure proper working conditions These instructions should help you get started with your new Luxtec equipment quickly and easily If you have any problems please contact the Luxtec Service Department 800 325 8966 or 508 835 9700 Fax 1 508 835 9976 ADJUSTMENTS ALL HEADLIGHT SYSTEMS To ensure long life for the headband cable and modules they should be stored in the duffel bag provided Fiber optic cables are fine high quality optical instruments You can prolong the useful life by following a few guidelines Avoid stretching your cable forming configura
7. nd variable spot module gown clips and a bifurcated fiber optic cable To assemble the headlight attach the variable spot module Fig l Fig to the headband by sliding the tapered bottom end of the module into the headband Fig 2 and push the top into the headband Fig 3 until it makes an audible click Fig 3 To attach the fiber optic cable insert the bifurcated metal fitting into the module Fig 4a b until it clicks into place Fig 4a ULTRALITE PRO HEADLIGHT SYSTEM ASSEMBLY Fig 4b Thread the bifurcated cable on the left and right of the central headband unit Fig 5 in an over under pattern as shown Continue threading the bifurcated cables on the left and right of the headlight adjustment bracket in an over under pattern as shown Fig 6 Fig 6 The cable can be slid forward or backward to allow more slack for comfort as needed To remove the cable from the module grasp the strain relief in one hand and the module in the other hand and pull the strain relief straight up DO NOT disassemble by grasping the bifurcated cables as damage to the glass fibers may occur WARNING The cable is made of glass fibers When adjusting the cable on the headband do not bend the cable more than 60 degrees When properly assembled the cable should curve gently around the contours of the head and the headband MOD EZIO LUNTEC ULTRALITE PRO HEADLIGHT SYSTEM A
8. ng shipment This warranty is non sterilization solution transferable unless authorized in writing by Luxtec There is a lens assembly at the light source end which Luxtec reserves the right to make design changes is not sealed and could allow moisture to penetrate on its products without liability to incorporate said behind the lens change in Luxtec products previously designed or sold Upon receipt of the product it should be carefully TROUBLESHOOTING inspected If any defect is discovered notification must For additional technical assistance please contact the immediately be given to the manufacturer Luxtec Service Department 800 325 8966 or 508 835 9700 Fax 1 508 835 9976 MOD GE e ULTRALITE9 PRO HEADLIGHT SYSTEM WARRANTY LUXTEC CABLE WARRANTY Luxtec warrants that the cables furnished shall be free from defects in material and workmanship under normal use and service for a period of 18 months UltraLite premium headlight cables feature a LIFETIME WARRANTY against browning RETURN POLICY REPAIR AND RETURN Any device must be clean when returned to Luxtec Luxtec reserves the right to return unrepaired any equipment that is contaminated with blood or other organic material WARRANTY SERVICE AND REPAIR To obtain service under warranty or return product for repair the customer should contact the local Luxtec representative or call Luxtec Customer Service at 800 325 8966 or 1 508 835 9700 ME
9. r Temperature dIa cote Intensity lin or Lamp Keep dry 4 AOG SFA us LEES Type CF Equipment Type BF Equipment High Temperature Brightness Motor Fan CE Listed by ETL Listed by CSA Part Number Batch Code Serial Number Authorized Representative in the European Community Manufacturer LUNTEC ULTRALITE PRO HEADLIGHT SYSTEM GENERAL WARNINGS The user should carefully study this manual before making any attempt to use the product clinically MODULE FIBER OPTIC Instructions should be followed specifically with BE special attention given to warnings and cleaning instructions This manual should also be available to the surgical team during a procedure TOP PAD Follow the instructions in the operating manuals of other manufacturer s equipment when they are used in conjunction with this product Before every procedure carefully inspect the fiber optic cable to ensure it has been properly maintained and cleaned and that it is fully functional CENTRAL M i Use the light source at the lowest possible ADJUSTMENT y X Sl attenuation to prevent cable damage or excess heat ZI Lich hich j itv hich ADJUSTMENT OCCIPITAL ight sources use high intensity lamps whic KNOB BASKET produce heat as well as brilliant light The heat produced by the light source and the light output of the fiber optic cable can cause burns Care should
10. tions involving sharp angles or kinks or contact with sharp or pointed objects The internal light fibers are made of glass a material which breaks under stress Fiber breakage will result in diminished light output Utilize the gown clips provided to keep the headlight cable secured to the surgeon s gown for greater comfort and maneuverability DO NOT use your fiber optic cable with any alterations to its original design or fabrication Keep the optical faces from contacting the floor or other hard surfaces The resulting scratches will diminish light output LUNTEC ULTRALITE PRO HEADLIGHT SYSTEM REPLACEMENT PARTS FOR ULTRALITE PRO HEADLIGHT Part Number Description AX2100BIF UltraLite amp Pro headlight assembly with 9 ft 275 cm premium bifurcated cable Mark Il module and gown clips AX2100BIFSL UltraLite amp Pro headlight assembly with 9 ft 275 cm premium bifurcated cable Mark Il module and gown clips with short linkage 001388LX9 UltraLite amp Pro premium bifurcated fiber optic cable 9 ft 275 cm 001388LX1 I UltraLite amp Pro premium bifurcated fiber optic cable II ft 335 cm 001388LX7P5 UltraLite amp Pro premium bifurcated fiber optic cable 7 5 ft 230 cm 001370LX UltraLite amp Pro replacement headband 001380LX Mark II module black CARE AND MAINTENANCE WARRANTY CLEANING MODULES The headlight module may be wiped down with LUXTEC HEADLIGHT WARRANTY alcohol The lens should be cleaned only

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