Welch Allyn ProXenon Headlight and Fiberoptic Cable
Contents
1. 3 Adjust the luminaire as close as possible to your face without touching the skin Coaxial Position Non coaxial Position recommended required for shadow free illumination 4 Adjust illumination spot size by turning iris control on luminaire 5 Sterilizable joystick is provided to facilitate luminaire adjustment with gloved hand Directions for Use Chapter 2 Assembly and Operation 15 WARNING Do not use headlight at distances closer than 10 inches 25 cm Tissue damage or erythema may result Concentrated high intensity light energy may result in thermal injury to the tissue The risk of injury is increased under the following conditions Prolonged close stationary illumination of tissue Using a high intensity light source at levels greater than needed for good visualization e Using multiple instruments to illuminate the same area The following recommendations will reduce the risk of thermal injury e Use the minimum level of illumination necessary for adequate visualization e When possible avoid close stationary viewing e Minimize exposure time 16 Chapter 2 Welch Allyn ProXenon Headlight and Fiberoptic Cable El Maintenance Cleaning Luminaire Rigid Headband And Fiberoptic Cable Exterior surfaces of luminaire rigid headband and fiberoptic cable can be wiped clean with any of these solutions e 10 bleach solution e 70 isopropyl alcohol e Mild soap e Cavicide wipes F2. tre chaude Manipuler avec pr caution Attention Seuls des techniciens Welch Allyn agr s sont habilit s proc der l entretien Attention Prot ger le dispositif d clairage contre les salet s la poussi re et autres contaminants Dans le cas contraire il s en trouverait endommag R ins rer le capuchon antipoussi re apr s avoir retir le c ble fibres optiques 6 Introduction Welch Allyn ProXenon Headlight and Fiberoptic Cable 7 PA assembly and Operation WARNING Do not shine light into eyes Eye injury may result Caution For optimal performance use with Welch Allyn ProXenon Surgical Illuminator Caution Keep dirt and contaminants out of the luminaire Damage may occur Always re cap luminaire when removing the fiberoptic cable Note Refer to the Welch Allyn ProXenon 350 Surgical Illuminator Directions for Use for instructions on operating light source 8 Chapter 2 Welch Allyn ProXenon Headlight and Fiberoptic Cable Fiber Optic Cable Light Source End Luminaire End Gown Clip 1 Carefully remove fiberoptic cable and headlight assembly from the respective packaging 2 Remove the dust caps from the luminaire and the fiberoptic cable Do not touch the end of the fiber Directions for Use Chapter 2 Assembly and Operation 9 Coolvent Headlight Assembly Adjustment Knobs i Fiberoptic Iris Control Joystick Cable Clips 1 Insert fiberoptic cable luminaire
3. Welch Allyn warrants the ProLight Headlight and Fiber guaranteed against all defects in materials and workmanship for a period of one year from date of sale to original purchaser Welch Allyn will repair or replace free of charge any component found to be defective for reasons other than misuse neglect damage in shipment or normal wear You must obtain a service notification number from Welch Allyn to return your Product before you send it to Welch Allyn s designated service center for repair Contact Welch Allyn Technical Support THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE WELCH ALLYN S OBLIGATION UNDER THIS WARRANTY IS LIMITED TO REPAIR OR REPLACEMENT OF PRODUCTS CONTAINING A DEFECT WELCH ALLYN IS NOT RESPONSIBLE FOR ANY INDIRECT OR CONSEQUENTIAL DAMAGES RESULTING FROM A PRODUCT DEFECT COVERED BY THE WARRANTY 22 Warranty Welch Allyn ProXenon Headlight and Fiber WelchAllyn Advancing Frontline Care Reorder No 90230MAN Material No 707227 Rev D Printed in U S A
4. Directions for Use 3 Warnings A warning statement in this manual identifies a condition or practice which if not corrected or discontinued immediately could lead to patient injury illness or death WARNING Users of this product should read and understand Directions For Use for the ProXenon Headlight Fiberoptic Cable and all equipment used with it WARNING Do not shine light into eyes Eye injury may result WARNING Do not use at distances closer than 10 inches 25 cm Tissue damage or erythema may result WARNING Do not remove fiberoptic cable from the luminaire while energized Intense light energy exiting the tip of energized fiberoptic cables may cause burns or fires Cautions A caution statement in this manual identifies a condition or practice which if not corrected or discontinued immediately could lead to equipment failure equipment damage or data loss Caution Rx Only United States Federal Law restricts this device to sale by or on the order of a health care practitioner Caution When removed from light source end of fiberoptic cable may be hot Use caution when handling Caution Service must be performed only by Welch Allyn authorized repair personnel Caution Keep dirt dust and other contaminants out of the luminaire Damage will occur Reinsert dust cap after removing the fiberoptic cable 4 Introduction Welch Allyn ProXenon Headlight and Fiberoptic Cable Avertissements Les avertissements d
5. USA Contents T Introduction v iS eee eee eu eS ee 1 Intended Use s itn ts de Ie br ebd Pb dots Ps 1 GontraindiGatlOriv n 4 Boe ata ees hu Rasa eG E 1 User Pr file 4 osx eed die PE MEA E Ped 1 Symbol Descriptions 2 WYANT OS ce oou tme tex LE Petre e i etes 3 CAUTIONSS cues tetas Sante tn fo Dh ctl up oat das eti cert 3 Avertissements 2 24 ie Bek bo sepa PEE URP EUR 4 PreCaUtlOFiSs4 e mad autom hela Adu dut ober be b mod 5 2 Assembly and Operation 7 Fiber Optic Cablen i isa ceste qo net kela Meat etd s 8 Coolvent Headlight Assembly 9 Coolvent Fleece Headband Assembly 10 CONNECONS gt caecus oe thas IN EE Ae eRe ae eA 12 Headlight Operation 12 3 MaintenanGe se k ares de Bohn ie 17 CISA Ge s oos Rs Ray hPa RRR okt PEE Ain aga s 17 Luminaire Rigid Headband And Fiberoptic Cable 17 Fib roptic Cables i su these ee d en 17 JOYSTICK i steep EPA MA SE AE OEE Ate 18 Recommended Steam Sterilization Parameters 18 SpecifiGatiols Sos MR RM se ches te tao S RON 19 Ordering Parts And Components 20 WAaEFaib esse ets SOR Ron er qa ee dut 21 iv Contents Welch Allyn ProXenon Headlight and Fiber m Introduction Thank you for purchasing the Welch Allyn ProXenon Headlight and Fiberoptic Cable Follow the guidelines provided in this manual and you will enjoy years of dependable trouble f
6. Welch Allyn ProXenon Headlight and Fiberoptic Cable Directions for Use Welch Allyn Advancing Frontline Care ii Copyright Information Welch Allyn ProXenon Headlight and Fiberoptic Cable Copyright 2008 Welch Allyn Welch Allyn is a registered trademark of Welch Allyn Welch Allyn is protected under various patents and patents pending Welch Allyn assumes no responsibility for any injury to anyone or for any illegal or improper use of the product that may result from failure to use this product in accordance with the instructions cautions warnings or statement of intended use published in this manual Welch Allyn Technical Support USA Tel 1315 685 2993 Australia 61 29 638 3000 Fax 1 315 685 2999 Canada 800 561 8797 China 86 216 327 9631 European Call Center 353 46 906 7790 France 4 331 6009 3366 Germany 49 747 792 7186 Japan 81 33 219 0071 Latin America 1 305 669 9003 Netherlands 31 15 750 5000 Singapore 65 6419 8100 South Africa 27 11 777 7555 United Kingdom 44 207 365 6780 Sweden 46 85 853 6551 Reorder Number 90230MAN Material No 707227 Rev D Welch Allyn European Regulatory Manager Lighting Products Group Welch Allyn Ltd 4619 Jordan Road Navan Business Park PO Box 187 Dublin Road Skaneateles Falls NY 13153 Navan County Meath USA Republic of Ireland www welchallyn com Tel 353 46 90 67700 Fax 353 46 90 67755 CE WelchAllyn Advancing Frontline Care Printed in
7. e ce manuel identifient les conditions ou pratiques qui si elles ne sont pas corrig es ou arr t es imm diatement risquent de provoquer des blessures des maladies ou le d c s du patient A AVERTISSEMENT Les utilisateurs de ce produit doivent lire et comprendre le mode d emploi de la lampe frontale du c ble fibres optiques ProXenon et de tout le mat riel utilis conjointement AVERTISSEMENT Ne pas orienter la lumi re vers les yeux Des l sions oculaires pourraient s ensuivre AVERTISSEMENT Ne pas utiliser des distances inf rieures 25 cm 10 pouces Des l sions tissulaires ou des ryth mes pourraient s ensuivre AVERTISSEMENT Ne pas retirer le c ble fibres optiques du dispositif d clairage lorsqu il est sous tension L intense nergie lumineuse qui sort de l extr mit des cables fibres optiques sous tension pourrait g n rer des br lures ou des incendies Directions for Use 5 Pr cautions Les pr cautions de ce manuel identifient les conditions ou pratiques qui si elles ne sont pas corrig es ou arr t es imm diatement risquent de provoquer des pertes de donn es un endommagement ou une d faillance du mat riel Attention Sur prescription uniquement en vertu de la loi f d rale des Etats Unis ce produit ne peut tre vendu que par un m decin ou sur prescription m dicale Attention Lorsqu elle est extraite de la source lumineuse l extr mit du c ble fibres optiques peut
8. end into the top of luminaire 2 Press fiberoptic cable into clips 10 Chapter 2 Welch Allyn ProXenon Headlight and Fiberoptic Cable Coolvent Fleece Headband Assembly Directions for Use Chapter 2 Assembly and Operation 11 12 Chapter 2 Welch Allyn ProXenon Headlight and Fiberoptic Cable Connections 1 Insert fiberoptic cable light source end into Storz port of the ProXenon 350 Surgical Illuminator 2 Turn ProXenon 350 Surgical Illuminator on Adjust light intensity to the minimum level necessary for adequate visualization Headlight Operation Caution Overtightening adjustment knobs will damage the gear teeth 1 Prepare the headband a Coolvent headband Remove and discard used pad set and replace with new pad set REF 90242 Use the headband adjustment knobs to open the headband to the largest size Place the headband on your head with the luminaire centered between your eyes Tighten the crown adjustment knob The headband should rest just above the eyebrows Tighten the rear adjustment knob for proper fit Directions for Use Chapter 2 Assembly and Operation 13 Adjustment bs CH Kno 2 b Coolvent Fleece headband Open the velcro strips and wrap the Coolvent Fleece headband comfortably around your head Fasten the velcro strips together to secure Secure fiberoptic cable to surgical gown with gown clip 14 Chapter 2 Welch Allyn ProXenon Headlight and Fiberoptic Cable
9. iberoptic Cable Wipe the ends of the fiberoptic cable clean with a cloth dampened with alcohol Allow to dry before use Avoid scratching or striking ends of fiberoptic cable Light transmission losses can result To inspect fiberoptic cable for light transmission losses remove from light source and headlight assembly Hold one end of fiberoptic cable up to room lighting Examine other end Replace fiberoptic cable if 25 or more of end area is dark A Caution Verify that ends of the fiberoptic cable are clean High intensity light will be absorbed by any residue including cleaning and disinfecting solutions on the surface of the fiberoptic Absorbed light will overheat the residue causing damage to the fiberoptic cable 18 Chapter 3 Welch Allyn ProXenon Headlight and Fiberoptic Cable Joystick Joystick is autoclavable Unscrew joystick from luminaire Clean with mild soap and water use soft brush if necessary Rinse with clean water Sterilize in standard steam or flash autoclave Q RS Recommended Steam Sterilization Parameters Sterilizer type Gravity Minimum temperature 132 C Cycle time 15 minutes Sample configuration Individually pouched device Directions for Use Chapter 3 Maintenance 19 Specifications Dimensions Rigid Headband with Luminaire 28 cm x 17 8 cm x 17 8 cm 11 in x7 in x7 in Weight Rigid Headband with Luminaire 176 g 6 2 oz Fiberoptic cable 8 ft 244 cm standard length 107 g 3 8 oz Fiberopt
10. ic cable 10 ft 305 cm standard length 134 g 4 3 oz Light Spot Diameter at Large Spot Luminaire REF 90234 40 mm to 120 mm 16 in 41 cm working Small Spot Luminaire REF 90235 20 mm to 70 mm distance Fiberoptic Cable Storz Style Connector Interface Environment Operation 59 F 15 C to 86 F 30 C Storage 13 F 25 C to 131 F 55 C Conforms to EN60601 1 UL 60601 1 CSA C22 2 NO 601 1 IEC 60601 1 20 Chapter 3 Welch Allyn ProXenon Headlight and Fiberoptic Cable Ordering Parts And Components The Welch Allyn ProXenon Headlight is designed for use with Welch Allyn fiberoptic cables 90220 90221 90228 90229 90230 90231 90232 90233 90234 90235 90240 90241 90242 90243 90244 90245 Fiberoptic Cable 8 ft 244 cm standard length Fiberoptic Cable 10 ft 305 cm standard length Wolf Adapter Gown Clips 30 ProXenon Large Spot LS Headlight on Coolvent Headband ProXenon Large Spot LS Headlight Coolvent Fleece Headband ProXenon Small Spot SS Headlight Coolvent Headband ProXenon Small Spot SS Headlight Coolvent Fleece Headband ProXenon Large Spot LS Headlight Module only ProXenon Small Spot SS Headlight Module only CoolVent Headband only ProXenon Coolvent Fleece Conversion Kit CoolVent Replacement Pad Sets 100 per case Replacement Coolvent Fleece Headband 3 pack ProXenon Joysticks 2 ProXenon Headlight Nylon Storage Bag 5 pack 21 Warranty
11. ree service from your new headlight Intended Use The Accessory Headlight is a passive luminaire that is illuminated by fiberoptic light and utilized to provide supplemental light for surgical and medical procedures Contraindication This product is contraindicated for use in neonate transillumination ophthalmic procedures photosensitive patients or patients receiving photosensitizing agents hematoporphyrin derivatives within 3 months User Profile The intended users of the ProXenon Headlight and fiber are medical professionals who are qualified to perform surgical procedures 2 Introduction Welch Allyn ProXenon Headlight and Fiberoptic Cable Symbol Descriptions These important symbols may appear on your Welch Allyn ProXenon Headlight and Fiberoptic Cable Please note their meaning Warning Caution Latex Free Attention Read the Directions For Use Manual for all warnings precautions and instructions for use amp Caution high E Caution high intensity light A temperatures with the provisions noted in both the 89 336 EEC Electromagnetic The CE mark indicates this product has been tested to and conforms C Compatibility Directive and the 93 42 EEC Medical Device Directive European Contact for Regulatory Compliance European Regulatory Manager Welch Allyn Ltd Navan Business Park Dublin Road Navan County Meath Republic of Ireland Tel 353 46 90 67700 Fax 353 46 90 67755
Download Pdf Manuals
Related Search