LS8000 Direct LED Light Source Instruction Manual April 2014

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Proprietary Information This manual contains information deemed proprietary to ConMed Corporation. The information contained herein, including all of the designs and related materials, is the sole property of ConMed and/or its licensors. ConMed and/or its licensors reserve all patent, copyright and other proprietary rights to this document, including all design, manufacturing methodology and reproduction. This document, and any related materials, is confidential and is protected by copyright laws and shall not be duplicated, transmitted, transcribed, stored in a retrieval system, or translated into any human or computer language in any form or by any means, electronic, mechanical, magnetic, manual or otherwise, or disclosed to third parties, in whole or in part, without the prior express written consent of ConMed. ConMed reserves the right to revise this publication and to make changes from time to time in the contents hereof without obligation to notify any person of such revision or changes, unless otherwise required by law. Linvatec, Hall, Smart OR and Smart are trademarks or registered trademarks of ConMed Corporation.

 ConMed Corporation 2014. All Rights Reserved.

Record the Model and Serial Numbers of the light source controller and date received. Retain for future reference. Light Source Model No.

Serial No

Date

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Table of Contents

1.0

Page

INTRODUCTION 1.1

Intended Use... 1

1.2

Contraindications... 1

1.3

Receiving Inspection... 1

1.4

Safety Information... 1

1.5

Warnings... 2 1.5.1

To Avoid Fire Hazard or Electrical Shock... 2

1.5.2

To Avoid Personal Injury and Damage to the Light Source... 3

1.5.3

Unplug the Device from the Wall Outlet if any of the Following Occur... 3

1.6

Theory of Operation... 4

1.7

Life Expectancy... 4

1.8

Environmental Directives... 5

1.9

Product Photographs and Drawings... 5

1.10 Symbol Definitions... 6 1.11 System Features... 8 1.11.1 Front Panel... 8 1.11.2 Rear Panel... 9

2.0

3.0

SYSTEM INSTALLATION and OPERATION 2.1

Installation Instructions... 10

2.2

Operation of Light Source... 10

2.3

Other Operational Features... 11

MAINTENANCE 3.1

Cleaning... 13

3.2

Fuse Replacement... 14

3.3

Troubleshooting... 16

3.4

Error Messages... 17

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Table of Contents

4.0

5.0

Page

TECHNICAL INFORMATION 4.1

Light Source... 18

4.2

Lamp Module... 19

4.3

Power Cord Requirements... 19

4.4

Electromagnetic Requirements... 20

4.5

Accessories/Compatible Equipment... 23

CUSTOMER SERVICE 5.1

Assistance and Repair... 24

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1.0 INTRODUCTION It is recommended that personnel study this manual before attempting to operate and/or clean the ConMed LS8000 Direct LED Light Source and accessories. The safe and effective use of this equipment requires the understanding of and compliance with all warnings, cautionary notices, and instructions marked on the product, and included in this manual.

1.1 Intended Use The ConMed LS8000 Direct LED Light Source is intended to be used with an endoscope to provide illumination during endoscopic procedures.

1.2 Contraindications None.

1.3 Receiving Inspection Upon receipt, carefully unpack the light source and accessories. Ensure all items listed below are included in the box and are free from damage. If any damage is noted contact your ConMed Customer Service. Save ALL packaging materials; they may be needed to verify any claims of damage by the shipper. • LS8000 Direct LED Light Source: The detachable power cord is sold separately and is packaged in a separate box. • C7104 Power Cord - 115VAC • C7105 Power Cord - 230VAC.

1.4 Safety Information This equipment is designed for use by medical professionals completely familiar with the required techniques, and the instructions for use of the equipment. Read and follow all warning and cautionary notices and instructions marked on the product and included in this manual. It is important to read, understand, and comply with all of the following safety precautions. Failure to follow these precautions could result in injury to the patient or user or cause damage to the LS8000 Light Source or associated equipment. After each use, thoroughly clean the unit and accessories (See “3.1 Cleaning”).

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1.5 Warnings 1. To avoid risk of electric shock, this equipment must only be connected to a supply mains using a detachable power cord with protective earth.

!

2. Do not attempt to open or service the light source chassis. There are no user-serviceable parts inside. Removing the cover may introduce an electric shock hazard by exposing you to dangerous high voltages or other risks. If the system malfunctions, return it for service immediately. 3. Use of this light source and the accompanying light guide can cause the scope tip to get hot as a result of high intensity light. Do not allow the light emitting end of the light guide to contact either the patient or the surgical drape. This can cause the drape to ignite and potentially cause severe burns to the patient and / or operating room personnel. 4. Do not use in the presence of flammable anesthetics, gases, disinfecting agents, cleaning solutions, or any material susceptible to ignition due to electrical sparking. There is a possibility of explosion. 5. Do not use a cardiac defibrillator on a patient without first removing from the patient the endoscope to which the light source is attached. 6. Do not use in surgical procedures requiring direct illumination of the eye. 7. This device is designed for use in standard medical environments. Components of the system that are meant for patient contact are constructed from biocompatible materials. 8. To avoid risk of injury due to improper configuration, ensure that applied parts from other suppliers of electro-medical devices, or any accessories used for endoscopic application in this configuration, are of type BF or type CF. 9. Before each use ensure that intended to be utilized light guides and endoscopes are compatible with LS8000 Light Source and meet safety criteria per this Manual. 1.5.1 To Avoid Fire Hazard or Electrical Shock 1. Prior to each use, the light source and all associated equipment must be inspected for proper operation. 2. Use only non-conducting light guides (optical cable). Verify that the light guide is dry and free from cleaning solution residue before plugging it into the light source. 3. Use only the detachable power cord specified for this device. The detachable power cord is the means to isolate the Light Source from the mains. 4. Do not use plug adapters or extension cords; such devices defeat the safety ground. 5. Do not excessively bend or kink the power cord. Always inspect cords for signs of excessive wear or damage. If wear or damage is found, discontinue use and replace immediately. 6. Unplug the power cord from the outlet when performing any kind of cleaning or general maintenance. 7. Use only the fuse type and rating specified for this device. 8. Do not apply an input voltage that is outside the specified range. 9. Do not expose the light source to moisture, or operate the light source in either damp or wet areas, or place liquids on or above the light source. 10. Do not operate the light source in an explosive atmosphere. 11. Do not allow foreign objects inside the light source. 2

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12. Do not disassemble the light source. There are no user-serviceable parts inside. 13. Never spill liquids of any kind on the device or immerse it in liquids. 14. Only plug the light source into a properly grounded hospital-grade outlet. 1.5.2 To Avoid Personal Injury and Damage to the Light Source 1. Do not use the light source with incompatible equipment or accessories that are not authorized by ConMed. Doing so may void certifications and/or warranties. 2. Do not place light source on an unstable surface, cart, stand, or table. 3. Do not allow the light source to share an electrical outlet or grounding with life supporting or life sustaining equipment. 4. Only connect IEC 60950 or IEC 60601 series compliant devices to signal input or output ports. 5. Do not look directly or indirectly at the lamp when it is on. The lamp produces high intensity visible light that may cause burns to skin or eyes. 6. Do not operate the light source with suspected failures. If you suspect there is damage to this product, have it inspected by qualified personnel. Refer to “5.0 customer service”. 7. Do not block ventilation slots or openings. Provide at least four inches of free air space between the sides of the light source and any hard surface. 1.5.3 Unplug the Device from the Wall Outlet if any of the Following Occur 1. The power cord is damaged. 2. Liquid has been spilled on the device or it has been exposed to other moisture. 3. The device has been dropped or damaged in any way. 4. The product displays a distinct change in performance. 5. The product does not operate properly when the operating instructions are followed.

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1.6 Theory of Operation The LED light source uses a LED illuminator module as a generator of white light. As opposed to previous generation technologies such as Xenon lamps based on high pressure gas bulbs, the LED (Light Emitting Diode) illuminator is based on solid-state semiconductor technology and therefore is more robust, durable and more efficient in converting electrical energy into visible light output. LED technology allows for extended life time of the illumination module so that periodic replacement of the module is no longer necessary. The main component of the illumination module is a single high power white LED device. The LED is comprised of a semiconductor chip (also called a die) that emits light when electrical current flows across the p-n junction of the die. Based on semiconductor physics the die emits light in a narrow band region of blue part of the visible spectrum. In order to generate white light the die is coated with a special semitransparent phosphor that emits green and red portion of the spectrum once excited by blue light. In aggregate - the blue light is transmitted through the phosphor layer, and green and red bands generated within the phosphor - constitute full band bright white light output. The light output of the LED device is channeled into a specially designed fiber-optic system where the light beam is homogenized and formatted for optimal coupling with endoscopic light guides and scopes. Cooling of the LED die is very important for proper operation of the light source and for its longevity. A number of cooling means are used in the light source enclosure at different levels from heat sinks directly attached to the LED substrate to forced air flow paths both inside and outside of the illumination module. The light source has integrated thermal sensing circuitry that will shut off the illuminator in the unlikely event of LED temperature exceeding its upper limit. The LED light source includes a push button switch for regulating the light intensity and the information display for indication of status, error modes, and brightness level. The light guide receptacle is designed for optimal retention force and optical coupling of ConMed light guides, but can also be used with Olympus and Storz Fittings. The receptacle also includes special sensing means for detection of the light guide. Until the light guide is fully inserted and locked in the receptacle, the LED illuminator remains shut down for increased safety.

1.7 Life Expectancy The standard warranty for this product is 24 months. The life expectancy of this product is expected to meet or exceed this period under normal use and standard care.

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1.8 Environmental Directives WEEE Directive [2002/96/EC] on Waste Electrical and Electronic Equipment. This statement only applies to European countries with regard to the Waste Electrical and Electronic Equipment (WEEE) European Directive. The WEEE symbol on the product or its packaging indicates that this product must not be disposed of with other waste. Instead, it is your responsibility to dispose of your waste equipment by handing it over to a designated collection point for the recycling of Waste Electrical and Electronic Equipment. The separate collection and recycling of your waste equipment at the time of disposal will help conserve natural resources and ensure that it is recycled in a manner that protects human health and the environment. For more information about where you can drop off your medical equipment at the end of its useful life for recycling, please contact ConMed.

1.9 Product Photographs and Drawings The pictures in this manual are for reference only. Items shown may not represent the actual product. However, procedural steps are identical, unless otherwise specified. When necessary, the actual pictures will be represented.

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1.10 Symbol Definitions

Symbol

IPX1

Meaning

Symbol

Power (ON/OFF)

Stand-by

Light Guide

Caution: High Voltage

Light Guide OPEN

Light Guide LOCKED

Date of Manufacture

Manufacturer

Ingress Potential (Protection against vertically falling water drops)

Type CF Equipment

No User Service Recommended. Refer servicing to qualified ConMed service personnel

REF

SN

Serial Number

Catalog Number

Trademark of Intertek Testing Services NA, Inc., a nationally Recognized Testing Laboratory, listing compliance as Medical Electrical Equipment to standard UL 60601 and CAN/CSA C 22.2 No. 601.1

Equipotential Ground

CE Mark of Conformity

Separate collection required. do not dispose equipment in municipal waste

Caution: Federal Law restricts this device to sale by or on the order of a physician

~

Mains Fuse EC REP

Meaning

Authorized Representative

Brightness Decrease

Alternating Current Brightness increase

Fragile

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Symbol

Meaning

Symbol

Atmospheric Pressure Limitation

Meaning Keep Dry

!

Do Not Use if Package is Damaged

Caution

Follow instructions for use

Cooling Fan Not Working

Lamp

Remote Control via Digital OR connector enabled

Camera Connected

Over Temperature

Maintenance Required

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1.11 System Features

3

5

4

2

6

1

1.11.1 Front Panel 1. “POWER” Button - Allows the user to toggle between light source OFF condition and light source ON condition. The associated “POWER” LED illuminates amber in light source OFF condition and green in light source ON condition. 2. “STAND-BY” Button - Allows the user to place the unit in stand-by mode to prevent light from exiting the light guide. Pressing the STAND-BY button again will return the brightness level to its previous setting and will allow light to be emitted through the light guide. 3. “DISPLAY” Liquid Crystal Display (LCD) -- Displays the settings of the light source such as stand-by mode, brightness level, warnings (fan stalled, overheating), maintenance required, remote connection, camera interface, and error messages. 4. “BRIGHTNESS” Buttons - Allows the user to increase or decrease the light output. 5. LIGHT GUIDE LEVER - Allows the user to open the LGR for insertion /removal of a fiber optic light guide. The lever is spring-loaded to hold the light guide during use. It also can be used to “lock” the light guide firmly in place. 6. LIGHT GUIDE RECEPTACLE (LGR) - Accepts and secures the fiber optic light guide. NOTE: Only insert clean, dry, non-conductive fiber optic light guides into the LGR.

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5 3

1

2

4

1.11.2 Rear Panel 1. “DIGITAL OR” Connector - Optional connector that can accept a RS232 Cable to allow remote control of the Light Source. 2. “CAMERA” Connector - This connector accepts a cable only from an optional ConMed IM8000 camera so that the camera can control the light source. 3. “POWER CORD” Receptacle -Accepts the hospital grade detachable power cord. 4. FUSE MODULE - Houses the fuses. Equipped with two F2.0A, 250V (slow blow) fuses. To replace the fuses, see “3.2 Fuse Replacement”. 5. EQUIPOTENTIALITY BONDING CONNECTION - Connect to an equipotential bonding strip if intracardial operations are being performed (IEC 60601-1-1/EN 60601-1-1 standards).

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2.0 SYSTEM INSTALLATION AND OPERATION 2.1 Installation Instructions Attach the hospital grade detachable power cord to the power cord receptacle on the back panel of the light source, and a hospital grade grounded power outlet. If desired, connect the light source to the “LIGHT SOURCE” Connector on the IM8000 camera.

2.2 Operation of Light Source Use the following sequence to operate the light source: 1. 1.Press the POWER button to turn the light source on. The power button indicator will illuminate green and the LCD displays “STAND-BY”. 2. 2.Insert the fiber optic light guide into the LGR. NOTE: NOTE: Insert only clean, dry, non-conductive fiber optic light guides into the LGR. a. (a)Fully rotate the Light Guide Lever counterclockwise to the OPEN position. b. (b)Insert the light guide completely, then rotate the lever clockwise until the clicking of the locking mechanism is heard or felt.

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NOTE: If the light guide is not inserted completely into the LGR as seen in the photo above, and the STAND-BY button is pressed, the indicator ring around the LGR will flash blue & green. The LED illuminator will not light up. Rotate the lever counterclockwise, insert the light guide again, and then rotate the lever clockwise until the clicking of the locking mechanism is heard or felt. 3. Press the STAND-BY button to take the light source into the active mode. This will allow illumination through the light guide. LCD will display the brightness level. WARNING: Before each use or after a change of viewing modes or settings, the operator should check to ensure the view observed through the endoscope is a live image (rather than a stored one) and has the correct image orientation. WARNING: Before taking the light source out of stand-by mode, ensure that the output end of the light guide or endoscope is not in proximity to surgical drapes, flammable objects, or to the patient's skin. Operating room personnel or patient injury or burn may result.

4. Press the BRIGHTNESS buttons to set light output to the desired level. LCD will display the set brightness level. The light source is now ready for use. 5. To remove the light guide from the LGR: a. Place the light source in stand- by mode by pressing the STAND-BY button. b. Fully rotate the Light Guide Lever counterclockwise to the OPEN position and remove the light guide.

2.3 Other Operational Features 1. Light Source Power OFF: • When the light source is in the OFF condition, the POWER button indicator illuminates amber. Power will continue to run to the unit, but the LED light output is off. • STAND-BY and BRIGHTNESS buttons are inactive. • The LCD display is inactive.

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2. Light Source Power ON, STAND-BY mode enabled: • The light output is OFF. The POWER button indicator is green and the LGR indicator ring illuminates green. • The LCD displays “STAND-BY”.

• The BRIGHTNESS buttons are inactive. • Pressing the POWER button will turn the Light Source OFF. • Pressing the STAND-BY button will return the brightness level to its previous setting and will allow light to be emitted through the light guide, if the light guide is fully inserted. 3. Light Source Power ON, STAND-BY mode disabled: • The light output is on, the POWER button indicator illuminates green, and the LGR indicator ring illuminates blue, if the light guide is fully inserted. • The LCD displays “BRIGHTNESS“via a bar graph in increments of 5%. • The BRIGHTNESS Up Arrow increases brightness in increments of 5%. • The BRIGHTNESS Down Arrow decreases brightness in increments of 5%. • The STAND-BY button returns the light source to STAND-BY mode. The POWER button turns the light source off. 4.

Light Source ON, IM8000 Control cable connected: • The Camera icon is shown on LCD display. • The IM8000 Camera can be configured in such a way that the light source STAND-BY mode is enabled or disabled by Camera Head buttons. Refer to IM8000 Instruction Manual for detailed guidance. • The Light Source BRIGHTNESS level is controlled by IM8000 Camera and optimized according to IM8000 configuration setting. Refer to IM8000 Instruction Manual for detailed guidance.

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3.0 MAINTENANCE No modification of this equipment is allowed! This product has no user serviceable parts. If you need technical assistance regarding the use or application of this product, or you encounter a problem that requires servicing or repair, contact ConMed Customer Service at 1-800-237-0169 or your ConMed Sales Representative. Outside the U.S. contact your local ConMed Representative. Report any events involving injuries or malfunctions to the ConMed Regulatory Product Support. Returning products for any reason requires that you contact ConMed as described in Section . Regular and proper maintenance of your equipment is the best way to protect your investment. It is essential that you have your equipment serviced as scheduled in order to retain its optimum performance and reliability, which will reward you with safer, less problematic product performance over time. The equipment is not field repairable. Your ConMed authorized service department is the most knowledgeable about this equipment and its accessories and will provide competent and efficient services. Service at ConMed at the recommended service interval is mandatory to keep your product warranties in effect. Any services and/or repairs done by any unauthorized repair facility may result in reduced performance of the equipment or equipment failure. Refer to “5.0 customer service”. The LS8000 shall be returned every 12 months for servicing.

3.1 Cleaning 1. Unplug the light source and allow it and the fiber optic light guide to thoroughly cool before cleaning. 2. Wipe the exterior of the light source with a clean, soft cloth dampened (not dripping) with a mild detergent. Wipe again with distilled or sterilized water. Dry with a clean, lint-free towel.

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3.2 Fuse Replacement 1. Depress the “POWER” button to the off position and unplug the light source. 2. Using a small screwdriver or similar tool, gently release the retention tab on the fuse drawer and slide it out.

3. Pull out existing fuses and replace only with factory-supplied fuses (two F2.0A, 250V slow blow), as stated on the rear of the unit. Replace both fuses at the same time.

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4. Return fuse drawer to compartment, making sure alignment tab is on top. Snap into place.

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3.3 Troubleshooting Table 1: Troubleshooting Guide Symptom

Possible Cause

Corrective Action

• Plug power cord into receptacle and/or Light Source. • Power cord is not plugged in or is faulty. • Replace power cord. • Power is not turned on. Lamp Will not Light.

• Push POWER button in the ON position. The Power indicator will illuminate green when unit is on.

• System indicates over • Check the front display to see if warning, fan, temperature temperature. icons are on. Turn power off. Ensure intake vents are not blocked. Allow system to cool for five minutes. Turn power back on. If lamp does not light, call customer service. • Light guide not fully seated in the LGR.

• Check the ring around the LGR to ensure it is lit in steady blue. • Remove the light guide and fully reinsert into the LGR. • Take Light source off stand by.

• Brightness is set to minimum or too low of an output position. Low Light Output.

• Increase lamp brightness.

• Fiber optic light guide • Replace light guide. surface(s) is contaminated or damaged. • Excessive numbers of • Inspect light guide cables. If more than 20% of fibers are light guide fibers are broken (darkened), replace light guide. broken.

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