Welch Allyn ProXenon Headlight and Fiberoptic Cable

Welch Allyn ProXenon Headlight and Fiberoptic Cable

Welch Allyn ProXenon

Headlight and Fiberoptic Cable

Directions for Use

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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

Canada 800 561 8797

European Call Center + 353 46 906 7790

Germany + 49 747 792 7186

Latin America + 1 305 669 9003

Singapore + 65 6419 8100

United Kingdom + 44 207 365 6780

Australia + 61 29 638 3000

China + 86 216 327 9631

France + 331 6009 3366

Japan + 81 33 219 0071

Netherlands + 31 15 750 5000

South Africa + 27 11 777 7555

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

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

Printed in USA

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

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.

1

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.

Caution, high intensity light Caution, high temperatures

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

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.

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Introduction Welch Allyn ProXenon Headlight and Fiberoptic Cable

Avertissements

Les avertissements de ce manuel identifient les conditions ou pratiques qui, si elles ne sont pas corrigées ou arrêtées immédiatement, risquent de provoquer des blessures, des maladies ou le décès du patient.

AVERTISSEMENT Les utilisateurs de ce produit doivent lire et comprendre le mode d’emploi de la lampe frontale, du câble à fibres optiques ProXenon et de tout le matériel utilisé conjointement.

AVERTISSEMENT Ne pas orienter la lumière vers les yeux. Des lésions oculaires pourraient s’ensuivre.

AVERTISSEMENT Ne pas utiliser à des distances inférieures à 25 cm (10 pouces). Des lésions tissulaires ou des érythèmes pourraient s’ensuivre.

AVERTISSEMENT Ne pas retirer le câble à fibres optiques du dispositif d’éclairage lorsqu’il est sous tension.

L’intense énergie lumineuse qui sort de l’extrémité des câbles à fibres optiques sous tension pourrait générer des brûlures ou des incendies.

Directions for Use

5

Précautions

Les précautions de ce manuel identifient les conditions ou pratiques qui, si elles ne sont pas corrigées ou arrêtées immédiatement, risquent de provoquer des pertes de données, un endommagement ou une défaillance du matériel.

Attention Sur prescription uniquement : en vertu de la loi fédérale des États-Unis, ce produit ne peut être vendu que par un médecin ou sur prescription médicale.

Attention Lorsqu’elle est extraite de la source lumineuse, l’extrémité du câble à fibres optiques peut

être chaude. Manipuler avec précaution.

Attention Seuls des techniciens Welch Allyn agréés sont habilités à procéder à l’entretien.

Attention Protéger le dispositif d’éclairage contre les saletés, la poussière et autres contaminants. Dans le cas contraire, il s’en trouverait endommagé. Réinsérer le capuchon antipoussière après avoir retiré le câble à fibres optiques.

6

Introduction Welch Allyn ProXenon Headlight and Fiberoptic Cable

2

Assembly and Operation

7

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

9

Coolvent™ Headlight Assembly

Adjustment Knobs

Iris Control

Joystick

Fiberoptic

Cable Clips

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

3

Chapter 2 Assembly and Operation

11

4

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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

Adjustment

Knobs

Crown

Chapter 2 Assembly and Operation

13

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

(recommended; required for shadow free illumination)

Non-coaxial Position

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.

• 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

17

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

Minimum temperature

Cycle time

Sample configuration

Gravity

132

° C

15 minutes

Individually pouched device

Directions for Use Chapter 3 Maintenance 19

Specifications

Dimensions

Weight

Light Spot Diameter at

16 in (41 cm) working distance

Fiberoptic Cable

Interface

Environment

Conforms to:

Rigid Headband with Luminaire: 28 cm x 17.8 cm x 17.8 cm

(11 in x 7 in x 7 in)

Rigid Headband with Luminaire: 176 g (6.2 oz)

Fiberoptic cable, 8 ft (244 cm) standard length: 107 g (3.8 oz)

Fiberoptic cable, 10 ft (305 cm) standard length: 134 g (4.3 oz)

Large Spot Luminaire (REF 90234): 40 mm to 120 mm

Small Spot Luminaire (REF 90235): 20 mm to 70 mm

Storz Style Connector

Operation: 59° F (15° C) to 86° F (30° C)

Storage: -13° F (-25° C) to 131°F (55° C)

EN60601-1

UL 60601-1

CSA C22.2 NO 601.1

IEC 60601-1

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Chapter 3 Welch Allyn ProXenon Headlight and Fiberoptic Cable

90235

90240

90241

90242

90243

90244

90245

90228

90229

90230

90231

90232

90233

90234

Ordering Parts And Components

The Welch Allyn ProXenon Headlight is designed for use with

Welch Allyn fiberoptic cables.

90220

90221

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)

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Warranty

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.

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Warranty Welch Allyn ProXenon Headlight and Fiber

Reorder No. 90230MAN

Material No.707227 Rev. D

Printed in U.S.A.

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