WelchAllyn ProXenon 350 User manual

ProXenon 350 Surgical Illuminator

FiberSense

SAFTY PORT

Directions for Use

REF 902 Series

100%

Full Bright

Full Dim

Intensity

Increase

Decrease

Lamp Hours

ProXenon 350

Surgical Illuminator

Lamp on/off

ii Copyright Information Welch Allyn ProXenon 350 Surgical Illuminator

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 directions for use, cautions, warnings, or statement of intended use published in this manual.

Welch Allyn

is a registered trademark of Welch Allyn.

Call Welch Allyn Technical Support:

USA

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

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

Manual Reorder No. 90200MAN

Material No. 707224 Rev. F

Welch Allyn Lighting Products Group 4619 Jordan Road PO Box 187 Skaneateles Falls, NY 13153 USA

www.welchallyn.com

EC REP

Australia + 61 29 638 3000

European Regulatory Manager Welch Allyn, Ltd. Navan Business Park Dublin Road Navan, County Meath, Republic of Ireland Telephone: + 353 46 90 67700 Fax: + 353 46 90 67755

Printed in USA

Contents

1 - Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

iii

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Contraindication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

User Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Theory of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Light Source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Headlight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

A Brief Discussion about Light Intensity, Heat, Surgical Light Sources and

Surgical Headlights. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Risk of Fire . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Risk of Tissue Injury. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Risk of Fiber Damage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Safety Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Button Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Agency Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Safety Warnings and Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Avertissements et précautions d'usage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Avertissements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Mises en garde . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

2 - Controls and Function. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Front Panel Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Back and Side Panel Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

3 - Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

4 - Care and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Basic Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Fuse Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Lamp Care and Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Cleaning Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Transportation and Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Technical Assistance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Parts and Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

iv Contents Welch Allyn ProXenon 350 Surgical Illuminator

5 - Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Electrical Input . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Mechanical and Environmental. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Classification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

6 - Mobile Stand (Optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Assemble the ProXenon 350 Surgical Illuminator Mobile Stand . . . . . . . . . . . . 30

Mounting the ProXenon Light Source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Maintenance of the Mobile Stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Inspection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Introduction

The Welch Allyn ProXenon 350 Surgical Illuminator is designed for use with the Welch Allyn ProXenon Headlight and Fiber system. The ProXenon 350 Surgical Illuminator uses a Welch Allyn high-intensity, narrow-beam, rugged xenon, short arc lamp with a fixed internal reflector to produce a uniform profile beam.

Safety features include an interlock sensor that blocks light output unless a fiberoptic cable is inserted in the working port; an overheating shut-off; and a safety interlock door switch to prevent accidental electrical shock while changing the lamp.

The Four Port Turret accepts Wolf, Storz, Olympus, and ACMI fiberoptic cables. Each port is readily identified on the turret perimeter.

Intended Use

The Surgical Illuminator is designed for use with fiberoptic headlight systems. It will accept fiberoptic light guides for Wolf, Storz, Olympus, and ACMI instrumentation.

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, with rhinolaryngoscopes, ophthalmic procedures, photosensitive people, or people receiving photosensitizing agents (hematoporphyrin derivatives) within 3 months.

User Profile

Only qualified personnel should use the ProXenon 350 Surgical Illuminator.

Theory of Operation

Light Source

The ProXenon 350 Xenon light source is powered by filtered AC line power. The filtered power feeds the power supply board, which contains two major components, the 12VDC auxiliary supply, and the high voltage igniter board. The igniter board provides power for the 300W Xenon lamp and the auxiliary power provides for the balance of the light source components.

2 Introduction Welch Allyn ProXenon 350 Surgical Illuminator

The control logic board controls lamp on/off, display, shutter and safety interlock functions. The user interfaces with the control logic board by means of the front panel membrane switch assembly.

Fans provide cooling to the lamp and power supply and are powered by the auxiliary supply. ProXenon 350 uses parallel air flow design so that both power supply and fan are cooled with ambient air.

The lamp module contains a custom 300W Xenon Cermax style lamp kernel with a large anode design for improved lumen maintenance and an integral parabolic reflector. The parabolic reflector collimates the light that is launched into a optical train. The optical train contains:

• a shutter which controls total light intensity

• an optical filter which attenuates UV and IR radiation

• a condenser lens which focuses the light energy onto the face of fiberoptic cable

• a sensor which detects the presence of a fiberoptic cable allowing the shutter to open When the main power switch is depressed, power is supplied to the fans and displays.

When the lamp on/off membrane switch is pressed, ignition pulses are directed to the Xenon arc lamp. If the lamp fails to start, the ignition pulses time-out. If the lamp ignites, the green LED indicator above the lamp on/off membrane switch illuminates. Pushing the on/off membrane switch again turns the lamp off. It is normal to hear a “clicking” sound as the igniter attempts to start the lamp.

When a fiberoptic cable is inserted into the active port of the turret, a sensor sends a signal to the microprocessor allowing the shutter to open to the preset intensity setting. When the fiber is removed, the shutter closes to full dim position attenuating all light output. The intensity display shows the intensity setting as a continuous display when a fiber is inserted and a flashing display when no fiber is present and the shutter is closed.

Headlight

The light is transmitted via total internal reflection through the fiberoptic cable to the luminaire optics.

The luminaire optics consists of a two-element condenser lens assembly, a two-element projector (objective) lens assembly, a mirror and an objective window. The light exiting the face of the fiberoptic cable is collected by the condenser lens assembly and imaged slightly forward of the projector lens. The iris is completely filled by the condenser lens ray fans and is imaged by the projector lens 406mm from the projector window surface. The illumination spot is approximately 120mm in diameter and yields about 800 lumens at full iris opening with the light source at full open shutter.

A Brief Discussion about Light Intensity, Heat, Surgical Light Sources and Surgical Headlights

It is sound practice to always use the lowest possible intensity setting required to achieve good visualization. The ProXenon 350 Surgical Illuminator uses extremely restrictive UV and IR filtering to virtually eliminate the transmission of non-visible light energy. More than ninety-eight percent of all the radiant energy emitted from the ProXenon headlight system is in the form of full-spectrum (white) visible light.

Heat from the lamp is not transmitted through the fiberoptic cable to the luminaire. The perception of warmth caused by concentrated high intensity light is the result of the

Directions for Use Introduction 3

absorption of light into tissue and the conversion of that light energy to heat. Different tissues absorb and reflect different wavelengths of light. The combination of reflected wavelengths is what we perceive as color. If specific wavelengths of light are not reflected, they are absorbed, and that absorbed light energy is converted to heat. Regardless of the brand or type of light used, light energy in excess of that required for good visualization will contribute to tissue warming and therefore should be avoided.

Risk of Fire

There is serious risk of igniting fires if the energized fiberoptic cables are placed on flammable materials. Never disconnect a terminal device from an energized fiberoptic cable or place an energized terminal device on any flammable material.

Risk of Tissue Injury

High intensity light can cause burns to tissue even if the tip of the fiberoptic cable or attached terminal device is cool. Burns are caused by the absorption of light by tissue and the subsequent conversion of that light energy into thermal energy (heat). Full-thickness burns can be caused by prolonged exposure to concentrated light energy. Anesthetized patients and poorly perfused tissues are particularly susceptible to burn injuries via this mechanism.

Risk of Fiber Damage

The ProXenon 350 Surgical Illuminator produces very high levels of visible light and is optimized to power the Welch Allyn ProXenon Surgical Headlight. When using endoscopic or surgical headlight fibers without canes, lenses or fusing at the input end, irreparable fiber damage may result when the ProXenon Surgical Illuminator intensity level is set above 70% and total accumulated lamp hours are 100 hours or less.

The ProXenon headlight fiber uses fusing technology at the input end to eliminate the use of epoxy as is common in the traditional fiber manufacturing process. It is primarily this epoxy that burns and causes fiber damage when exposed to high intensity light energy.

Welch Allyn has tested different brands and types of fiberoptic cables for durability in the ProXenon 350 Surgical Illuminator. Damage was found to most fibers with exposed epoxy ends when the ProXenon 350 Surgical Illuminator intensity is set above 70% and the lamp has less than 100 hours of accumulated use. Fiberoptic cables that use fusing techniques, a cane, or a lens on the input end of the cable, show better tolerance to the intense visible light energy of the ProXenon 350 Surgical Illuminator. However, because Welch Allyn cannot control other manufacturer's materials or manufacturing processes, any brand or type of fiberoptic cable previously tested and shown to withstand the light energy of the ProXenon 350 Surgical Illuminator could fail if the manufacturer implements a change in process or material of said fiber. Therefore, Welch Allyn cannot attest to the survivability of any fiberoptic cable used in the ProXenon 350 Surgical Illuminator other than the 902 series ProXenon Headlight Fiber.

4 Introduction Welch Allyn ProXenon 350 Surgical Illuminator

Symbols

The following symbols are associated with the ProXenon 350 Surgical Illuminator.

Safety Symbols

Identifies information within the manual to avoid injury.

Caution: consult accompanying documents.

Alternating Current

Type BF Equipment

Recycling Symbol- Do not dispose of this product as unsorted municipal waste. Prepare this product for reuse or separate collection as specified by Directive 2002/96/EC of the European Parliament and the Council of the European Union on Waste Electronic and Electrical Equipment (WEEE). If this product is contaminated, this directive does not apply. See www.welchallyn.com/weee or contact Welch Allyn Customer Service.

IPXØ

Identifies information within the manual to avoid equipment failure.

Storage Humidity

Fuse

Dangerous Voltage

Equipotentiality.

Attention, Hot Surface

Equipment is not protected against the ingress of liquid.

Transport Temperature

Directions for Use Introduction 5

Consult accompanying documents.

Lamp

Button Symbols

Power ON/OFF

Lamp ON/OFF

100%

Agency Symbols

Maximum light intensity

Minimum light intensity

Light intensity setting

Increases light intensity in 10% increments

Decreases light intensity in 10% increments

Lamp Hours

Medical electrical equipment with respect to electrical shock fire and mechanical hazards only in accordance with: UL60601-1 / CAN/CSA C22.2 NO.601.1

EMC Framework of Australia

The CE mark on this product indicates that it has been tested to and conforms with the provisions noted within the 93/42/EEC Medical Device Directive.

Authorized European Representative Address: European Regulatory Manager Welch Allyn, Ltd. Navan Business Park Dublin Road Navan, County Meath, Republic of Ireland Telephone: + 353 46 90 67700 Fax: + 353 46 90 67755

6 Introduction Welch Allyn ProXenon 350 Surgical Illuminator

Safety Warnings and Cautions

Familiarize all operating personnel with the general safety information in this summary. Specific warnings and cautions are also found throughout this manual. Such specific warnings and cautions may not appear in this summary.

Warnings

A warning statement in this manual identifies a condition or practice, which if not corrected or discontinued immediately, could lead to injury, illness, or death.

WARNING Only qualified personnel should use the ProXenon 350 Surgical Illuminator.

WARNING Before operating the ProXenon 350 Surgical Illuminator, read the Directions for Use. The ProXenon 350 Surgical Illuminator is a source of high electrical voltage, intense light, and heat. When used properly and with normal precautions, the ProXenon 350 Surgical Illuminator is a safe and effective light source.

WARNING RISK OF FIRE. Not suitable for use in the presence of a Flammable Anesthetic Mixture.

WARNING RISK OF SHOCK. The cover of the ProXenon 350 Surgical Illuminator should never be removed. Electrical shock hazard due to high internal voltage. There are no user serviceable parts inside this surgical illuminator except for the lamp and fuse which are accessible without removing the cover. Refer all service to Welch Allyn.

WARNING RISK OF SHOCK. Disconnect power cord before servicing.

WARNING This product comes with a power cord that is intended for use only

with this product. The power cord has not been tested and approved for use with other products that may have the same power connectors. If you cannot locate the original power cord, please contact Welch Allyn to obtain replacement parts.

WARNING Before connecting the ProXenon 350 Surgical Illuminator to AC power, verify that the voltage to be applied is within the range specified on the identification label.

WARNING Extremely high energy light. It is the user's responsibility to check the specifications of any device attached to the ProXenon 350 Surgical Illuminator to verify that it can transmit the intense light output without generating high temperatures and heat build-up in the device that can cause serious burns.

WARNING Use only non-electrically conductive fiberoptic cables. Use of conductive fiberoptic cables will compromise the safety and effectiveness of this instrument.

Directions for Use Introduction 7

WARNING High intensity light can cause burns to tissue even if the tip of the fiberoptic cable or attached terminal device is cool. Burns are caused by the absorption of light by tissue and the subsequent conversion of that light energy into thermal energy. Full-thickness burns can be caused by prolonged exposure to concentrated light energy. Anesthetized patients and poorly perfused tissues are particularly susceptible to burn injuries via this mechanism. There is serious risk of igniting fires if energized fiberoptic cables are placed on flammable materials. IT IS THE USER'S RESPONSIBILITY TO DETERMINE AND MAINTAIN THE MINIMUM SAFE DISTANCE BETWEEN THE END OF THE ENERGIZED fiberoptic CABLE AND ANY LIVING TISSUE OR FLAMMABLE MATERIAL.

WARNING Intense light emitted from the ProXenon 350 Surgical Illuminator can cause permanent eye damage if viewed directly with unprotected eye. The risk of injury is reduced by using the minimum level of illumination necessary, by minimizing exposure time, and by avoiding close stationary viewing.

WARNING There is a risk of injury to tissue from exposure to the intense illumination. Using light intensity settings in excess of that required for good visualization contributes to tissue warming and should be avoided.

WARNING Always have back-up light source available in case of failure during a procedure.

WARNING The lamp module and nearby structures become VERY HOT, even after brief operation. To prevent burns, turn off the ProXenon 350 Surgical Illuminator and allow it to cool for 10 minutes prior to removing lamp module.

WARNING When the ProXenon 350 Surgical Illuminator is on, never disconnect the fiberoptic cable from the terminal device. High intensity light from the end of the fiberoptic cable can ignite flammable materials (for example, drapes) or cause burns to tissue.

WARNING Replace fuses as marked. See Fuse Replacement Section.

WARNING Do not use for neonate transillumination. Erythema may result.

WARNING Ensure that active port of the Four-Port Turret is positioned correctly

and the fiberoptic cable is fully seated.

WARNING The ProXenon 350 Light Source has been evaluated for use as a Headlight System light source only. The safety and effectiveness of this light source for endoscopic use has not yet been evaluated.

8 Introduction Welch Allyn ProXenon 350 Surgical Illuminator

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 Do not touch or change lamp module immediately after operation. Allow lamp to cool 10 minutes.

Caution Since the ProXenon 350 Surgical Illuminator uses a custom lamp module, always have a spare lamp module available for replacement. Use only Welch Allyn replacement lamp module REF 90209.

Caution To prevent damage to the ProXenon 350 Surgical Illuminator, prevent overheating, and maintain the warranty, replace lamp only with Welch Allyn REF 90209 lamp module. Read instructions before replacing lamp module.

Caution Grounding reliability is achieved only when connected to hospital-use or hospital-grade receptacles. Inspect electrical plug and cord routinely. Do not use if damaged.

Caution PROVIDE VENTILATION TO PREVENT OVERHEATING. Keep cooling vents free from obstructions. Do not cover or drape the ProXenon 350 Surgical illuminator. Provide a 6 inch (15.24 cm) distance between the ProXenon 350 Surgical Illuminator and any solid objects. Use the ProXenon 350 Surgical Illuminator only when it is in the horizontal position.

Caution Do not use the turret as a light attenuator or operate with the turret misaligned with the light port.

Caution The metal end of the fiberoptic cable gets hot during use. Allow to cool before touching.

Caution IPXØ - Equipment not protected against the ingress of water. Do not use or store liquids above or on the surgical illuminator.

Caution The ProXenon 350 Surgical Illuminator produces very high levels of visible light and is optimized to power the Welch Allyn ProXenon Headlight and Fiber. When using endoscopic or surgical headlight fibers without canes, lenses, or fusing at the input end, irreparable fiber damage will result when the ProXenon 350 Surgical Illuminator intensity level is set above 70% and total accumulated lamp hours are 100 hours or less.

Caution When using fibers other than the 902 series ProXenon headlight fiber, do not exceed 70% intensity setting when total accumulated lamp hours are less than 100.

Caution Do not operate the ProXenon 350 Surgical Illuminator without a lamp module installed.

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