LS7700 300 Watt Xenon Light Source Instruction Manual Rev AB March 2014

Proprietary Information This manual contains information deemed proprietary to ConMed Linvatec. The information contained herein, including all of the designs and related materials, is the sole property of ConMed Linvatec and/or its licensors. ConMed Linvatec 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 Linvatec. ConMed Linvatec 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 Linvatec

 Linvatec Corporation 2012, 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

Table of Contents

1.0

2.0

INTRODUCTION 1.1

Operating Principle... 1

1.2

Indications for Use... 1

1.3

Intended Use... 1

1.4

Contraindications... 1

1.5

Warnings and Precautions... 2 1.5.1

Warnings... 2

1.5.2

Precautions... 4

1.6

Environmental Directives... 5

1.7

Product Photographs and Drawings... 5

1.8

Symbol Definitions... 5 1.8.1

Product Symbols... 5

1.8.2

Warning and Information Symbols... 6

SYSTEM INSTALLATION AND OPERATION 2.1

2.2

Product Description... 8 2.1.1

LS7700 Front Panel... 8

2.1.2

LS7700 Rear Panel... 9

Assembly/Installation Instructions... 10 2.2.1

3.0

Page

LS7700 Installation Instructions... 10

2.3

Operating Instructions... 11

2.4

Preoperative Functional Test... 14

MAINTENANCE 3.1

Cleaning Information... 15 3.1.1

Warnings, Precautions and Notes... 15

3.1.2

Manual Cleaning Instructions... 15 i

Table of Contents

Page

3.1.3

Light Guide Cleaning Instructions... 15

3.2

4.0

3.2.1

Warnings, Precautions and Notes... 16

3.2.2

Sterilization Instructions... 16

3.2.3

Light Guide Sterilization Instructions... 16

3.3

Troubleshooting... 17

3.4

Life Expectancy... 18

3.5

Maintenance Schedule... 18

3.6

Fuse Replacement... 19

3.7

Leakage Test... 20

3.8

Lamp Hours Check... 20

3.9

Lamp Replacement... 21

TECHNICAL SPECIFICATIONS 4.1

4.2

4.3

5.0

Sterilization Information... 16

Product Technical Specifications... 23 4.1.1

Technical Specifications... 23

4.1.2

Power Cord Requirements... 23

4.1.3

Lamp Module Specifications... 24

Product Environmental Requirements... 24 4.2.1

Environmental Technical Specifications... 24

4.2.2

Electromagnetic Requirements... 25

Accessories... 29

CUSTOMER SERVICE 5.1

Assistance and Repair... 30

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1.0 INTRODUCTION It is recommended that personnel study this manual before attempting to operate, clean, or sterilize this or associated equipment. The safe and effective use of this equipment requires the understanding of and compliance with all warnings, precautionary notices, and instructions marked on the product, and included in this manual. This equipment is designed for use by medical professionals completely familiar with the required techniques and instructions for use of the equipment. Service intervals, as listed in section “3.5 Maintenance Schedule”, are required to keep the equipment at its optimum operating performance.

1.1 Operating Principle The ConMed Linvatec LS7700 300W Xenon Light Source is an electricity (AC-powered) device that provides light of high intensity, often called cold light, for viewing surgical fields and body cavities when using rigid or flexible endoscopes, e.g., arthroscopes, cystoscopes, laparoscopes, gastroscopes. The light is channeled via a light guide cable connecting this device to the endoscope to illuminate the site of observation/intervention while minimizing tissue heating. Between the bulb and Light Guide port are a series of optical elements that homogenize the light, increase the Numerical Aperture of the light and filter a significant portion of the infrared and UV light. The total light output will vary from 1300-1800 Lumens. A manual shutter is used to control the emitted brightness. The temperature on the surface of the lamp can be very high; therefore, cooling is very important during operation. The lamp must be allowed to cool in accordance with the included instructions before any handling is attempted. The lamp is very fragile and should be handled with extreme care. If cracked or dropped, the lamp can easily break explosively since the lamp is under high pressure. A lamp hour meter is mounted on the lamp module to track lamp life.

1.2 Indications for Use The ConMed Linvatec LS7700 300 Watt Xenon Light Source is intended to be used with an endoscope to provide illumination during endoscopic procedures.

1.3 Intended Use Same as Indications for Use above.

1.4 Contraindications None.

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1.5 Warnings and Precautions

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Do not bypass this section. It contains warnings and precautions that must be thoroughly understood before operating any of the equipment. Lack of understanding or adherence to these warnings and precautions may result in injury or even death to the patient. The words WARNING, PRECAUTION, and NOTE carry special meanings and they must be read carefully. WARNING: A warning contains critical information regarding serious adverse reactions and potential safety hazards that can occur in proper use or misuse of the equipment. Failure to observe the information or procedures presented in a Warning may result in injury, death or other serious adverse reactions to the patient and/or surgical staff.

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PRECAUTION: A precaution contains instructions for any special care to be exercised by the practitioner for the safe and effective use of the equipment. Failure to observe the information or procedures presented in a Precaution may result in damage to the equipment.

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NOTE: A note is added to provide additional focused information. This information has no critical effect on the patient or equipment. 1.5.1 Warnings 1. Eye protection is recommended when operating equipment. Eye injury may result.

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2. It is the surgeon's responsibility to be familiar with the appropriate surgical techniques prior to use of the equipment and its associated accessories. 3. Do not use equipment if, upon receipt, package is opened, damaged, or shows any signs of tampering. 4. Do not use equipment in the presence of flammable anesthetics, gases, disinfecting agents, cleaning solutions, or any material susceptible to ignition due to electrical sparking. 5. To avoid the risk of electric shock, this equipment must be connected to a supply mains with protective earth. The voltage and frequency characteristics must be compatible with those listed on the unit or in this manual. Do not use plug adapters or extension cords; such devices may defeat the safety ground and could result in injury. 6. Do not excessively bend or kink the equipment power cord or accessory cord. Always inspect cords for signs of excessive wear or damage. If wear or damage is found, discontinue use and replace immediately. Using a damaged power cord could possibly cause injury. 7. Do not use a cardiac defibrillator on a patient without first removing from the patient the endoscope to which the light source is attached. 8. Use of this light source and light guide accessory may cause the scope tip and light post to become 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. 9. Do not touch the lamp until it has cooled to room temperature. Severe burn may result. 10. Do not use in surgical procedures requiring direct illumination of the eye. 11. 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. Wear a face shield or safety eye glasses and inspection gloves when handling the lamp assembly. 2

12. Use only the fuse type and rating specified for this device. Using the wrong type of fuse could cause damage or injury. 13. Do not over-ride the safety feature associated with the lamp access door. The lamp access door must be closed and latched for the light source to work. Overriding this safety feature and operating the light source with the door open could cause injury. 14. Loss of illumination will result in loss of visualization of the surgical field and result in an injury to the patient. 15. Avoid contact with other non “BF” rated powered instruments while in contact with the patient, as this may create a current leakage path to earth. 16. Clean console and all associated equipment prior to first use and after each use (Refer to section “3.2 Sterilization Information”). Clean and sterilize associated instrumentation used with this console if required. Reference the appropriate Instruction Manual or IFU for each piece of equipment. 17. Do not connect known damaged equipment or equipment that is corroded or wet. Failure to comply may cause injury or result in damage to equipment. 18. Do not allow foreign objects inside the light source. Damage to the light source or injury could result. 19. Do not insert finger in the Light Guide Receptacle. This constitutes a safety hazard and can cause extensive damage or injury. 20. Do not immerse the equipment in fluids. Immersion may render the device inoperable. 21. Do not simultaneously contact the console and patient. This may contaminate the sterile field and create an unsafe electrical condition. 22. Hot air may exit the Light Guide Receptacle when in operation but no light guide installed. 23. This equipment should not share an electrical outlet or grounding with life supporting or life sustaining equipment. 24. This system may cause radio interference or may disrupt the operation of nearby equipment. Avoid stacking equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the console or shielding the location.

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1.5.2 Precautions 1. United States Federal law restricts sale of this device to or on the order of a physician.

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2. This device should only be used in compliance with its intended use. 3. Handle all equipment carefully. If any equipment is dropped or damaged in any way, return it immediately for service. 4. Use only ConMed Linvatec approved equipment, attachments and accessories. They have been tested and certified to specific medical standards. Using unapproved accessories may result in improper operation, may negatively affect EMC performance and may result in non-compliance to medical standards. 5. The warranty becomes void and the manufacturer is not liable for direct or resulting damage if: • The device or the accessories are improperly used, prepared or maintained; • The instructions in the manual are not adhered to; • Non-authorized persons perform repairs, adjustments or alterations to the device or accessories. 6. There are no user-serviceable parts inside. No modification of this equipment is allowed. 7. Prior to each use, perform the following: • Ensure all accessories are correctly and completely attached. (Refer to section “2.2 Assembly/ Installation Instructions”). • Perform the required Preoperative Functional Tests for the equipment and accessories. (Refer to section “2.4 Preoperative Functional Test”). 8. Clean and sterilize all the equipment and associated accessories according to instructions for use. (Refer to section “3.1 Cleaning Information” and section “3.2 Sterilization Information”). 9. Do not expose the equipment to moisture, operate the equipment in damp or wet areas, or place liquids on or above the equipment. 10. Do not place the equipment on an unstable surface, cart, stand or table. Additionally, the equipment must remain in an upright position. 11. Only connect IEC 60950 or IEC 60601 series compliant devices to signal input or output ports. 12. Do not leave fingerprints or any other residue on the lamp reflector surface or the bulb. 13. Do not subject the lamp to mechanical forces or rough handling that may fracture the lamp as this may result in an explosion. 14. Inspect all airflow inlets and outlets for any obstructions to ventilation to avoid potential overheating. 15. Ensure power cord placement does not interfere with installing the device.

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1.6 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 Electric 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 Linvatec.

1.7 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.

1.8 Symbol Definitions 1.8.1 Product Symbols Stand-by (ON/OFF)

Reference User’s Manual for Catalog Number

Stand-by (Light)

Light Guide

Increase (Brightness)

Decrease (Brightness)

Light Guide OPEN

Light Guide LOCK

Shutter Control

Brightness

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1.8.2 Warning and Information Symbols Catalog Number

REF

! EC REP

Manufacturer

Date of Manufacture

Consult Instructions for Use

Refer to Instruction Manual/Booklet (for critical safety instruction). The color is blue.

Caution

DEHP Symbol

Authorized Representative in the European Community

CE Mark of Conformity

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

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

Non Sterile STERILE

2

STERILIZE

EO

Serial Number

SN

Sterile - Sterilized Using EO

STERILE STERILE

R

Sterile Sterile - Sterilized Using Irradiation

Do Not Steam Sterilize

Do Not Sterilize

Do Not Resterilize

Do Not Reuse (for Single Use Only)

Do Not Use Oil

Caution - Hot Surface

Eye Protection Required

Biohazard Risk

Do Not Immerse

QTY

Quantity

Type B Applied Part

Type BF Applied Part

UL Classification Mark

UL Recognized Components

Rating Fuse

Fuse Location

6

~

Alternating Current

Protective Earth Ground

Equipotentiality (Equipment Potential)

Non-Ionizing Electromagnetic Radiation (RF Symbol)

Temperature Limitation

Humidity Limitation

Atmospheric Pressure Limitation

Use by Date

Fragile

This Side Up

Do Not Use if Package is Damaged

Keep Dry

Do not Stack

Warning: Electrical Hazard/High Voltage

Waste Electrical and Electronic Equipment (WEEE) Symbol. Regarding European Union end-of-life of product, indicating separate collection for electrical and electronic equipment Recycle. Batteries contain materials which must be recycled or disposed of properly. The disposal of batteries as municipal waste is prohibited. Dispose or recycle in accordance with your local, state and governmental regulations. In the U.S. call 1-800-237-0169, or outside the U.S. contact your local ConMed Linvatec representative for additional information on battery disposal or recycling.

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2.0 SYSTEM INSTALLATION AND OPERATION 2.1 Product Description 2.1.1 LS7700 Front Panel

3

4

5

6

2

1

1. “POWER” Button - Allows the user to toggle between light source OFF condition and light source ON condition. The associated “POWER” LED illuminates orange 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. Organic Light Emitting Diode (OLED) Display - Displays the settings of the light source such as stand-by mode, brightness level, lamp life hours remaining and power on or off. 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.

LOCK

6. Light Guide Receptacle (LGR) - Accepts and secures the fiber optic light guide. When in stand-by mode the light guide receptacle (LGR) illuminates green.

OPEN

NOTE: Only insert clean, dry, non-conductive fiber optic light guides into the light guide receptacle (LGR).

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2.1.2 LS7700 Rear Panel

2

3 4

7

1

5

6 1. Fan - Provides cooling to the Light Source. Keep free of dust and dirt accumulation. 2. “MEMORY CARD” Slot - Provides a means for future software upgrades or diagnosis by ConMed Linvatec authorized representatives. 3. “NETWORK” Connector - Allows external control. 4. “CAMERA” Connector - This connector accepts an IM9030 ethernet cable only from an optional ConMed Linvatec IM4000 series camera so that camera can control the light source. 5. Power Cord Receptacle - Accepts the hospital grade power cord. 6. Fuse Module - Houses the fuses. Equipped with two F6.3A, 250V (fast blow) fuses. To replace a fuse, refer to section “3.6 Fuse Replacement”. 7. “POTENTIAL EQUALIZATION” Connector (POAG) - Plug mating connector from potential equalization system to POAG to bring equipment to equal ground potential in accordance with DIN 42801.

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2.2 Assembly/Installation Instructions 2.2.1 LS7700 Installation Instructions NOTE: Ensure power cord placement does not interfere with installing the device. 1. Attach a hospital grade 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 IM9030 ethernet cable from the light source connection port to the connection port on the IM4000 series camera. Refer to section “4.1.2 Power Cord Requirements”and “4.3 Accessories”. 2. Note: To accommodate some fiber optic light guides, the LGR adapter may need to be removed. To remove the LGR adapter: a. Insert a coin into the slot of the LGR adapter.

b. Rotate the coin counterclockwise until the adapter is fully removed. NOTE: Upon applying power to the unit the following display indicates the system is initalizing.

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2.3 Operating Instructions Use the following sequence to operate the light source: 1. Press the “POWER” button to turn the light source on. The “POWER” LED will illuminate green and the OLED displays “STAND-BY” and remaining LAMP life.

2. Insert the fiber optic light guide into the LGR. NOTE: Insert only clean, dry, non-conductive fiber optic light guides into the light guide receptacle (LGR). a. Fully rotate the Light Guide Lever counterclockwise to the OPEN position. b. Insert the light guide completely, 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 out of stand-by mode. This will allow illumination through the light guide. OLED will display the brightness level.

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. 11

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4. Press the “BRIGHTNESS” buttons to set light output to the desired level. OLED will display the set brightness level. 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. 1. Light Source OFF: • When the Light Source is in the OFF condition, the “POWER” LED illuminates orange. Power will continue to run to the unit, but the lamp is not on. • “STAND-BY” and “BRIGHTNESS” buttons are inactive. Pressing the “POWER” button will turn the Light Source on. • The OLED display is inactive. NOTE: The lamp door must be completely closed or the unit will not operate. “Door Open” message will be displayed.

2. Light Source ON, Stand-by mode enabled: • When the light source is in the ON condition, the lamp is on and the “POWER” LED and LGR illuminate green. • The OLED displays “STAND-BY” and remaining Lamp Life Hours. • 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. 3. Light Source ON, Stand-by mode disabled: • When the light source is in the ON condition, the lamp is on, the “POWER” LED illuminates green and the LGR illuminates blue. • The OLED 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, Auto Shutter Control: • To enable Auto Shutter control, the IM9030 ethernet cable must be connected between an IM4000 series ConMed Linvatec camera and the light source.

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• The IM4000 series “CAMERA HEAD” button can enable or disable the stand-by mode. a. When stand-by mode is enabled: • OLED displays “STAND-BY” and remaining lamp life hours. • The “BRIGHTNESS” buttons are inactive. The “POWER” button will turn the light source OFF. The “STAND-BY” button returns the light source to Auto Shutter mode. b. When stand-by mode is disabled: • The “BRIGHTNESS” buttons are controlled by the IM4000 series camera to achieve the desired picture brightness. • The “STAND-BY” button returns the light source to stand-by mode. The “POWER” button will turn the light source OFF. 5. Lamp Life: • When the light source is in the ON condition and the stand-by mode is enabled, the OLED displays lamp life hours remaining, beginning at 500 hours and counting down to zero in increments of one hour. • When lamp life is 10 hours or less, the OLED displays a blinking message to indicate nearing end of life or at end of life.

6. Lamp Replacement: • For installation instructions refer to section “3.9 Lamp Replacement”. Read all warnings and cautionary notices carefully before performing any service procedures. Refer to section “1.5 Warnings and Precautions”. • Replace only with ConMed Linvatec Lamps. Use of unauthorized lamps will void certifications and/or warranties and may affect safety and performance. 7. Lamp Saver: • If light source is in stand-by mode, continuously for one hour, the light source lamp will turn off. When stand-by mode is disabled, the lamp will turn on and the light source will return to normal operation.

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2.4 Preoperative Functional Test 1. Connect the light guide to the light source. 2. With distal end of light guide facing away from personnel, press the “POWER” button on the front panel of the light source to toggle from “STAND-BY” to “ON”. 3. Press BRIGHTNESS Up arrow and note increasing brightness on the display and the distal end of the light guide; press BRIGHTNESS Down arrow and note decreasing brightness on the display an the distal end of the light guide. 4. Place light source back in stand-by mode by pressing the “STAND-BY” button.

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3.0 MAINTENANCE 3.1 Cleaning Information 3.1.1 Warnings, Precautions and Notes

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1.

Follow universal precautions for protective apparel when handling and cleaning contaminated instruments.

2.

Clean instruments within 30 minutes after use to minimize the potential of blood and debris drying.

3.

Never clean equipment in an ultrasonic cleaner.

4. Always detach accessories from equipment prior to cleaning. 5. Never clean equipment with bleach, chlorine-based detergents, liquid or chemical disinfectants, or any products containing sodium hydroxide (such as, INSTRU-KLENZ or Bell Cleaner). These products degrade the anodized aluminum coating and may result in reduced equipment reliability. 6. For aluminum surfaces, a neutral-pH agent should be used. To prevent corrosion, avoid contact with strong alkaline solutions (pH over 10.5) or agents containing iodine or chlorine. Refer also to Section “1.5 Warnings and Precautions”. 3.1.2 Manual Cleaning Instructions 1. Turn the equipment power off. Disconnect the equipment from the electrical power source. 2. Remove any accessories from the equipment that may be attached. 3. Wipe the equipment with a clean, soft cloth dampened with a mild, pH-balanced detergent of your choosing. Ensure you follow the manufacturer's instructions for the cleaning product that you select that it is approved for use on plastics. Failure to follow these guidelines may cause damage to the equipment. Repeat cleaning if necessary until clean. 4. Ensure equipment is free of all debris. 5. After cleaning the equipment, wipe it again with a clean, soft cloth dampened with distilled or sterilized water. 6. Dry all areas thoroughly with a clean, soft cloth. 7. Perform functional checks according to Section “2.4 Preoperative Functional Test”. Check mating accessories closely for proper assembly. 8. Remove and repair any damaged equipment. Repeat Manual Cleaning Instructions as necessary. 3.1.3 Light Guide Cleaning Instructions Refer also to appropriate Light Guide Instruction for Use.

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3.2 Sterilization Information 3.2.1 Warnings, Precautions and Notes 1. The use of disinfecting solutions for an exterior instrument wipe will not sterilize the equipment and is not recommended.

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2. Do not sterilize equipment or accessories using Ethylene Oxide (EtO). 3. Do not sterilize equipment or accessories using a STERIS system or by comparable sterilization methods. 4. Do not sterilize equipment or accessories in cold sterilants like CIDEX. 5. Always detach accessories from equipment prior to sterilization. 6. Do not sterilize the console. Refer also to Section “1.5 Warnings and Precautions”. 3.2.2 Sterilization Instructions There are no sterilization instructions for this device since it is used outside of the sterile field. 3.2.3 Light Guide Sterilization Instructions Refer also to appropriate Light Guide Instruction for Use.

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