ProXenon Healight and Fiberoptic Cable Directions for Use Rev D

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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:+ 1 315 685 2993 Fax: + 1 315 685 2999

Australia + 61 29 638 3000

Canada 800 561 8797

China + 86 216 327 9631

European Call Center + 353 46 906 7790

France + 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 Lighting Products Group 4619 Jordan Road PO Box 187 Skaneateles Falls, NY 13153 USA www.welchallyn.com

Printed in USA

EC

REP

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

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Contents 1 Introduction... 1 Intended Use... 1 Contraindication... 1 User Profile... 1 Symbol Descriptions... 2 Warnings... 3 Cautions... 3 Avertissements... 4 Précautions... 5

2 Assembly and Operation... 7 Fiber Optic Cable... 8 Coolvent™ Headlight Assembly... 9 Coolvent Fleece Headband Assembly... 10 Connections... 12 Headlight Operation... 12

3 Maintenance... 17 Cleaning... 17 Luminaire, Rigid Headband, And Fiberoptic Cable 17 Fiberoptic Cable... 17 Joystick... 18 Recommended Steam Sterilization Parameters . . 18 Specifications... 19 Ordering Parts And Components... 20

Warranty... 21

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Contents

Welch Allyn ProXenon Headlight and Fiber

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1 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-free 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.

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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.

Caution, high temperatures

Caution, high intensity light

The CE mark indicates this product has been tested to, and conforms with, the provisions noted in both the 89/336/EEC Electromagnetic 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

Directions for Use

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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.

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Introduction

Welch Allyn ProXenon Headlight and Fiberoptic Cable

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2 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.

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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

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Coolvent™ Headlight Assembly Adjustment Knobs

Fiberoptic Cable Clips

Iris Control

Joystick

Luminaire

1.

Insert fiberoptic cable luminaire end into the top of luminaire.

2. Press fiberoptic cable into clips.

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Chapter 2

Welch Allyn ProXenon Headlight and Fiberoptic Cable

Coolvent Fleece Headband Assembly 1

2

Directions for Use

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4

Chapter 2 Assembly and Operation

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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

Adjustment Knobs

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Crown

Rear

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. 2. Secure fiberoptic cable to surgical gown with gown clip.

Gown Clip

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Chapter 2

Welch Allyn ProXenon Headlight and Fiberoptic Cable

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

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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. Using multiple instruments to illuminate the same area.

The following recommendations will reduce the risk of thermal injury: •

Use the minimum level of illumination necessary for adequate visualization.

•

When possible, avoid close stationary viewing.

•

Minimize exposure time.

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Chapter 2

Welch Allyn ProXenon Headlight and Fiberoptic Cable

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3 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: •

10% bleach solution

•

70% isopropyl alcohol

•

Mild soap

•

Cavicide wipes

Fiberoptic 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. 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.

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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.

Recommended Steam Sterilization Parameters Sterilizer type

Gravity

Minimum temperature

132° C

Cycle time

15 minutes

Sample configuration

Individually pouched device