ProXenon Healight and Fiberoptic Cable Directions for Use Rev A

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Copyright Information

Welch Allyn ProXenon Headlight Camera System

Copyright 2009 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 Tel:+ 1 315 685 2993 Fax: + 1 315 685 2999

Reorder Number 90270MAN Material No. 712067 Rev. A Authorized European Representative Address: 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 Welch Allyn Lighting Products Group 4619 Jordan Road PO Box 187 Skaneateles Falls, NY 13153 USA www.welchallyn.com

Contents 1 Camera Introduction... 1 Intended Use... 1 User Profile... 1 Symbol Descriptions... 2 Agency Information... 4 Warnings... 5 Cautions... 7

2 Assembly and Operation... 9 Video Processor Controls and Functions... 9 Front and Side Panel Functions... 9 Back Panel Functions... 10 Headlight Camera Functions... 11 Camera Operation... 15 White Balance Adjustment... 16

3 Care and Maintenance... 19 Basic Troubleshooting... 19 Cleaning... 20 Luminaire, Fiber Optic and Camera Cable, Rigid Headband, Camera, and Video Processor... 20 Camera Lens... 20 Specifications... 21 Electromagnetic Compatibility... 23 Ordering Parts And Components... 28

Warranty... 29

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Contents

Welch Allyn ProXenon Headlight Camera System

1 Camera Introduction Thank you for purchasing the Welch Allyn ProXenon Headlight Camera System. Follow the guidelines provided in this manual, and you will enjoy years of dependable, trouble-free service from your new camera system.

Intended Use The surgical headlight camera is intended to provide remote viewing of the surgical procedure by health care professionals. The image may be recorded for documentation or training purposes. This device is not intended to provide images for diagnostic use.

User Profile The intended users of the ProXenon Headlight Camera System are medical professionals who are qualified to perform surgical procedures.

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Camera Introduction

Welch Allyn ProXenon Headlight Camera System

Symbol Descriptions These important symbols may appear on your Welch Allyn ProXenon Headlight Camera System. Please note their meaning.

IPXØ

Y/C

Hazard; 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

Not protected against the ingress of liquids. S-Video chromaticity and illuminance

AWB

Video

White Balance

Composite video

Power On

Power Off

Magnetic Field

Manufacturer

DC Current

Polarity of DC power connector

Directions for Use

3

Indoor Use only

Class II 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.

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Camera Introduction

Welch Allyn ProXenon Headlight Camera System

Agency Information 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.

US

C

166292

Approval Agency EN/IEC 60601-1 UL60601-1 CAN/CSA C22.2 No. 601.1-M90 IEC60601-1-2

Authorized European Representative Address: 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

RoHS

RoHS Compliant

EMC Framework of Australia N344

Directions for Use

5

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 RISK OF FIRE. Not suitable for use in the presence of a Flammable Anesthetic Mixture. WARNING Users of this product should read and understand the Directions For Use for the ProXenon Headlight Camera System and all equipment used with it. WARNING Users of this product should read and understand the Directions For Use for the ProXenon 350 Surgical Illuminator, Ref 90200MAN, and the Welch Allyn ProXenon Headlight and Fiberoptic Cable, Ref 90230MAN, and all equipment used with them. WARNING Do not shine light into eyes. Eye injury may result. WARNING When removed from light source, end of Fiberoptic cable may be hot. Use caution when handling. 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. WARNING Do not focus lens during surgical procedures. WARNING Ensure that the Camera and Fiberoptic Cable Management Straps are fully secured prior to each use.

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Camera Introduction

Welch Allyn ProXenon Headlight Camera System

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.

Directions for Use

7

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 No user serviceable parts. Service must be performed only by Welch Allyn authorized repair personnel. Caution For optimal performance use with Welch Allyn ProXenon Surgical Illuminator. Caution For proper operation keep dirt, liquids, and contaminants out of the Luminaire, Camera, and Camera Connections. Damage may occur. Caution Do not adjust focus over the surgical field. The lens may detach from camera if the normal focal range is exceeded. Caution Avoid contaminating the interior of the camera head. When changing lenses, ensure you are in a clean, dust-free environment.

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Camera Introduction

Welch Allyn ProXenon Headlight Camera System

2 Assembly and Operation Video Processor Controls and Functions Front and Side Panel Functions Camera Head Connector: Connects the Camera Head to the Video Processor.

Magnetic Base

Power Indicator LED

Power button: Main Power ON/OFF.

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Chapter 2

Welch Allyn ProXenon Headlight Camera System

Back Panel Functions S-Video Out Connector (Y/C): Connects to S- video input of a video display or recording device

Manual White Balance (Push AWB): Sets white balance

DC Jack: Connects to power supply

Composite Video Out Connector (Video): Connects to composite video input of a video display or recording device

Interface Cable: Connects magnetic base to Video Processor

S- Video Out Connector (Y/C): Connects to S-Video input of a recording device or video display

Directions for Use

Chapter 2 Assembly and Operation

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Headlight Camera Functions WARNING Users of this product should read and understand the Directions For Use for the ProXenon 350 Surgical Illuminator, Ref 90200MAN, and the Welch Allyn ProXenon Headlight and Fiberoptic Cable, Ref 90230MAN, and all equipment used with them. WARNING Do not shine light into eyes. Eye injury may result. Caution For optimal performance use with Welch Allyn ProXenon Surgical Illuminator. Cable Management Straps

Fiberoptic Cable Camera Cable Camera Head

Luminaire Focusable Lens

1.

Carefully remove Camera and Headlight assembly from their respective packaging.

2. Place the Video Processor on the ProXenon 350 Surgical Illuminator. The magnetic base will securely hold the Processor in position.

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Chapter 2

Welch Allyn ProXenon Headlight Camera System

3. Insert power supply plug into DC Jack on the back of the Video Processor. Plug the power supply into a hospital grade wall receptacle. 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.

DC Jack

Video Processor power supply plug

Caution Ensure that power to the Video Processor is off prior to connecting to the Camera Head. Failure to follow this caution may result in damage to the Camera Head.

Directions for Use

Chapter 2 Assembly and Operation

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4. Connect one end of the Composite or an S-Video cable (Y/C) to the Video Processor and the other to your monitor or digital recording device. 5. Remove the dust caps from the Luminaire, Camera, and the Fiberoptic cable. Do not touch glass surfaces. 6. Insert Fiberoptic cable into Storz port of the ProXenon 350 Surgical Illuminator. 7.

Align the notch located on the Camera Cable Connector with the key on the Video Processor before attempting to insert the cable. Caution Failure to align the notch on the Camera Cable Connector with the key on the Video Processor may result in damage to the pins of the Camera Head Connector.

8. Insert the Camera Cable into the Connector of the Video Processor.

Camera Head Connector

Camera Cable Connector

9. Thread the Camera Cable Connector clockwise until secured.

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Chapter 2

Welch Allyn ProXenon Headlight Camera System

10. Turn the ProXenon 350 Surgical Illuminator on and adjust light intensity to the minimum level necessary for adequate visualization. Note

Refer to the Welch Allyn ProXenon 350 Surgical Illuminator Directions for Use, Ref 90200MAN, for instructions on operating light source.

11. Turn the Video Processor on. The Power Indicator LED illuminates once power is turned on. 12. Confirm that your monitor correctly displays the video image. If there is no video signal, refer to “Basic Troubleshooting” on page 19. To shut down: 1.

Turn Video Processor power off.

2. Unplug the Camera Head from the Video Processor.

Directions for Use

Chapter 2 Assembly and Operation

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Camera Operation WARNING Users of this product should read and understand the Directions For Use for the Welch Allyn ProXenon 350 Surgical Illuminator, Ref 90200MAN, and the Welch Allyn ProXenon Headlight and Fiberoptic Cable, Ref 90230MAN, and all equipment used with them. WARNING Do not shine light into eyes. Eye injury may result. WARNING Ensure that the Camera and Fiberoptic Cable Management Straps are fully secured prior to each use.

Note

1.

Lens is pre-focused for 16 inch viewing distances before shipment.

Follow the steps in the Headlight Operation section of the Welch Allyn ProXenon Headlight and Fiberoptic Cable Directions For Use, Ref 90230MAN.

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Chapter 2

Welch Allyn ProXenon Headlight Camera System

Caution Do not adjust focus over the surgical field. The lens may detach from camera if the normal focal range is exceeded. 2. If desired, adjust camera focus by rotating lens. Rotate lens clockwise for close focus and counter clockwise for far focus.

Far focus

Close focus

White Balance Adjustment The Welch Allyn ProXenon Headlight Camera System is preset for white balance before shipment. If you desire to reset white balance: 1.

Confirm that the ProXenon 350 Surgical Illuminator is turned on. Press the Lamp ON/OFF button to ignite the lamp. Adjust light intensity to the minimum level necessary for adequate visualization.

2. Use a white target that fills the entire image, for example, a sheet of copier paper.