OPHTHALAS 532 Operators Manual Rev AC July 2003

®

OPHTHALAS 532 EyeLite Laser ®

OPERATOR'S MANUAL

Manufacturer: Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134-2099 U.S.A.

EU Authorized Representative: Alcon Laboratories (U.K.) Ltd. Boundary Way, Hemel Hempstead Hertfordshire, HP2 7UD England

Produced By: Alcon Laboratories, Inc. 15800 Alton Parkway Irvine, California 92618-3818 U.S.A.

Telephone: FAX:

949/753-1393 800/832-7827 949/753-6614

8065741078 Rev. AC, CATALOG NUMBER 905-5420-002 Rev. F, TEXT ONLY

© 1996-2003, Alcon, Inc

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EyeLite®

OPHTHALAS® 532 EYELITE® MANUAL REVISION RECORD DATE

REVISION

ECN NUMBER AND DESCRIPTION

08/2001

W

ECN # 20012930 - Initial release

10/2001

X

ECN # 20013239 - Added directions for replacing the ocular lens in the LIO. Pages affected: title, ii, iv, 6-30, 6-35.

04/2002

Y

ECN # 20022296 - Added information for LIO-AT; miscellaneous corrections. Pages affected: title, ii thru v, 6-1, 6-3, 6-36 thru 6-46, 7-1 thru 7-2.

06/2002

AA

ECN # 20022524 - Change part numbers and miscellaneous corrections. Pages affected: title, ii, 1-2, 5-1, 6-26, 6-35, 6-46.

06/2003

AB

ECN # 20032963 - Add CSO slit lamp data. Pages affected: i, ii, iii, v, 6-1, 6-47, 6-48.

07/2003

AC

ECN # 20033237 - Update laser label. Pages affected: i, ii, 1-4.

CSO is a registered trademark of Costruzione Strumenti Oftalmici S.R.L. Nikon is a registered trademark of Nikon Inc. Corporation. Topcon is a registered trademark of Kabushiki Kaisha Topcon Corporation. Meditec is a registered trademark of Meditec Reinhardt Thysel GMBH. Ellex is a registered trademark of Taracan Pty. Ltd. Zeiss is a registered trademark of Carl-Zeiss-Stiflung. Haag-Streit is a registered trademark of Haag-Streit AG Corporation. Heine is a registered trademark of Hein Optotechnik GmbH. * Registered U.S. Patent & Trademark Office ii

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TABLE OF CONTENTS TOPIC

PAGE #

Manual Revision Record... ii Foreword... vi Important Notice... vii Section One - General Information Introduction... 1-1 Warning Label Location Diagram... 1-4 Preparing For Installation... 1-5 EyeLite® Safety Features... 1-8 Professional Operator’s Information... 1-9 Product Service... 1-12 Limited Warranty... 1-12 Section Two - Description Front Panel Description... Rear Panel Description... Icons... Informative Messages...

2-1 2-5 2-7 2-9

Section Three - Operating Instructions Introduction... Initial Setup... System Connections... System Power Up... Normal Operating Procedure Using A Slit Lamp... Turn Off Sequence...

3-1 3-1 3-2 3-3 3-7 3-8

Section Four - Care And Maintenance Introduction... 4-1 Care And Cleaning... 4-1 Mirror And Lens Cleaning... 4-2 Fuse Replacement Procedure... 4-3 Calibration Verification... 4-4 Calibration Procedure... 4-12 Section Five - Troubleshooting Error And Fault Messages... 5-1 Section Six - Accessories And Parts Endoprobes... 6-2 "Y" Cable Kit for Dr. Filters... 6-2 Meditec Haag-Streit 900 BQ Link... 6-2 Slit Lamps with Dr. Filters and Adaptations... 6-3 Positioning the Dr. Filter... 6-6 Alcon SL 1000 and Zeiss 30SL Adaptation... 6-7 Zeiss SL 130 Adaptation... 6-12 EyeLite® 3000LE™* Bridge... 6-19 Alcon Laser Indirect Ophthalmoscope (LIO)... 6-23 Alcon Laser Indirect Ophthalmoscope-Advanced Technology (LIO-AT)... 6-36 Lift Table, CSO, AT-1100... 6-47 Section Seven - Index... 7-1 8065741078

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LIST OF ILLUSTRATIONS FIGURE #

iv

TITLE

PAGE #

Figure 1-1 Figure 1-2 Figure 1-3 Figure 1-4

The Ophthalas® 532 EyeLite® Laser... Warning Label Location Diagram... Recommended Laser Room Layout (Overhead View)... Remote Connector/Door Lamp Circuit Diagram...

1-1 1-4 1-5 1-6

Figure 2-1 Figure 2-2 Figure 2-3

EyeLite® Front Panel... 2-1 EyeLite® Display... 2-2 Rear Panel... 2-5

Figure 3-1 Figure 3-2 Figure 3-3

Slit Lamp Connections... 3-2 Turn On Sequence Flow Chart... 3-5 Label Location Diagram... 3-8

Figure 4-1 Figure 4-2 Figure 4-3 Figure 4-4 Figure 4-5 Figure 4-6 Figure 4-7

Fuse Location On EyeLite® Console... 4-3 Slit Lamp Exposure Time Configuration... 4-4 Slit Lamp Power Configuration... 4-5 LIO Exposure Time Configuration... 4-7 LIO Power Configuration... 4-8 Endoprobe Exposure Time Configuration... 4-10 Endoprobe Power Configuration... 4-10

Figure 6-1 Figure 6-2 Figure 6-3 Figure 6-4 Figure 6-5 Figure 6-6 Figure 6-7 Figure 6-8 Figure 6-9 Figure 6-10 Figure 6-11 Figure 6-12 Figure 6-13 Figure 6-14 Figure 6-15 Figure 6-16 Figure 6-17 Figure 6-18 Figure 6-19 Figure 6-20 Figure 6-21 Figure 6-22 Figure 6-23 Figure 6-24 Figure 6-25 Figure 6-26 Figure 6-27 Figure 6-28 Figure 6-29 Figure 6-30 Figure 6-31

Alcon SL 1000... 6-4 Zeiss 30SL... 6-4 Zeiss SL130... 6-4 Haag-Streit 900 BM... 6-4 Haag-Streit 900 BQ... 6-5 Zeiss OPMI 6 Microscope... 6-5 Connecting 'Y' Cable for Two Dr. Filters... 6-5 Dr. Filter Mounted Between Binoculars and Slit Lamp Assembly... 6-6 Label Location Diagram on Adaptation - Alcon SL 1000 shown... 6-8 Beam Splitter/Accessories placed between binoculars and Dr. filter... 6-8 Controls on Alcon SL 1000 Slit Lamp with Dr. Filter and Adaptation Installed... 6-9 Laser Spot Focus... 6-11 Label Location Diagram - Zeiss SL130... 6-13 Beam Splitter/Accessories placed between oculars and Dr. filter... 6-14 Icons Used on the Slit Lamp Adaptation... 6-14 Micromanipulator Controls... 6-15 Protective Dr. Filter (protected position shown)... 6-16 Positioning and Focusing the Laser Beam... 6-16 Laser Spot Focus... 6-17 EyeLite® 3000LE™* Bridge... 6-20 Remote Connector/EyeLite® 3000LE™* Bridge... 6-21 Commutation between the EyeLite® and the 3000LE™* Bridge... 6-21 Label Location Diagram - 3000LE™* Bridge... 6-22 The Alcon Laser Indirect Ophthalmoscope (CE version shown)... 6-23 Icons used on the Alcon LIO... 6-25 Alcon LIO Labeling... 6-25 Adjusting the LIO Overband... 6-27 Observation Optics Adjustment Knobs (CE version shown)... 6-28 LIO Controls for Observation and Illumination... 6-29 Eyecup Retainers and Ocular Lens on the Alcon LIO... 6-30 Location of Vertical Control Knob for Aiming Laser... 6-31

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LIST OF ILLUSTRATIONS FIGURE # Figure 6-32 Figure 6-33 Figure 6-34 Figure 6-35 Figure 6-36 Figure 6-37 Figure 6-38 Figure 6-39

TITLE

PAGE #

Alcon LIO Bulb Replacement... The Alcon Laser Indirect Ophthalmoscope-Advanced Technology... Alcon LIO-AT Labeling... Adjusting the LIO-AT Overband... LIO-AT Controls and Adjustments... Eyecup Retainers and Ocular Lens on the Alcon LIO-AT... Alcon LIO-AT Bulb Replacement... Lift Table, CSO, Model AT-1100...

6-34 6-36 6-38 6-40 6-41 6-42 6-46 6-48

LIST OF TABLES TABLE #

TITLE

PAGE #

Table 1-1 Table 1-2

Technical Specifications... 1-2 Laser Characteristics... 1-2

Table 2-1 Table 2-2

EyeLite® Messages... 2-9 EyeLite® Prompts... 2-10

Table 3-1

Default Settings... 3-4

Table 4-1 Table 4-2 Table 4-3 Table 4-4 Table 4-5 Table 4-6 Table 4-7 Table 4-8 Table 4-9

Slit Lamp Exposure Time Verification... 4-5 Slit Lamp Power Verification... 4-6 Slit Lamp Energy Matrix... 4-6 LIO Exposure Time Verification... 4-8 LIO Power Verification... 4-9 LIO Energy Matrix... 4-9 Endoprobe Exposure Time Verification... 4-10 Endoprobe Power Verification... 4-11 Endoprobe Energy Matrix... 4-11

Table 5-1 Table 5-2 Table 5-3 Table 5-4

Error Messages... Laser Fault Error... Software Fault Error... Hardware Fault Error...

Table 6-1 Table 6-2 Table 6-3 Table 6-4 Table 6-5

Slit Lamps with Adaptations and Accessories... 6-3 Adaptation Troubleshooting... 6-11 SL130 Adaptation Troubleshooting... 6-18 Alcon LIO Technical Specifications... 6-26 Alcon LIO-AT Technical Specifications... 6-38

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EyeLite®

FOREWORD This Operator's Manual is designed to acquaint the operator and operating room personnel with the Ophthalas® 532 EyeLite®. The manual presents an organized summary of the operating principles, main components, safety features, and instructions for care and use of the instrument. The information in this manual should be supplemented with reference works on laser theory and the interaction of laser energy with biologic tissues. No attempt is made in this manual to answer all the questions that arise during the use of the instrument in medical procedures. Questions concerning technique, safety and effectiveness should be referred to pertinent publications or recognized medical experts in laser surgery. Physicians should not attempt to treat patients with this instrument if not thoroughly familiar with its operation, or if in doubt as to its safe operation. All personnel authorized to use this instrument should be required to be thoroughly familiar with this manual. Please contact Alcon Surgical for complete technical support and service if you have questions concerning any aspect of this instrument's operation or if it fails to perform satisfactorily. To order supplies in U.S.A.: 800-862-5266 FAX: 800-241-0677 Outside U.S.A.: Contact your local Alcon representative for supplies.

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IMPORTANT NOTICE Equipment improvement is an on-going process and, as such, changes may be made to the equipment after this manual is printed. Pay close attention to WARNINGS and CAUTIONS in this manual. WARNINGS are written to protect individuals from bodily harm. CAUTIONS are written to protect the instrument from damage. Illustrations contained in this manual are for reference only. It is recommended that maintenance be performed by a qualified Alcon Field Engineer. Alcon Surgical shall not be liable for any damage resulting from failure to comply with the enclosed instructions. Alcon reserves the right to change specifications without further notice.

CAUTION U.S. Federal Law restricts this device to sale by or on the order of a physician only.

WARNINGS! Use of controls or adjustments, or performance of procedures other than those specified herein may result in hazardous laser radiation exposure.

A qualified technician must perform a visual inspection of the following components every twelve months. In case of a deficiency, do not use the system; call Alcon Technical Services. - Warning Labels - Power Cord - Fuses A qualified technician must check ground continuity and both polarities for leakage current every twelve months to ensure they are within the applicable standard (for example: EN 60601-1/IEC 601-1). Values must be recorded, and if they are above the applicable standard, or 50% above your first measurement, do not use the system; call Alcon Technical Services.

Comments or corrections concerning this manual should be addressed to: Alcon Technical Services Group PO BOX 19587 Irvine, CA, USA 92623 All rights reserved. No part of this manual may be reproduced, transmitted, or stored in a retrieval system, in any form or by any means; photocopying, electronic, mechanical, recording, or otherwise; without prior written permission from Alcon Laboratories, Inc.

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viii

LAST PAGE OF THIS SECTION

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SECTION ONE GENERAL INFORMATION INTRODUCTION The Ophthalas® 532 EyeLite® (EyeLite®) is a Neodymium-doped Yttrium Aluminum Garnet (ND: YAG) type laser which has been designed for ophthalmic use. LASER is an acronym for “Light Amplification by Stimulated Emission of Radiation.” This laser delivers a visible 532 nm green laser beam (frequency doubled), and a visible 670 nm Diode Laser aiming beam (670 nm is an approximate value between 660-680 nm).

Figure 1-1 The Ophthalas® 532 EyeLite® Laser

EyeLite® Laser Generation Principle The EyeLite® laser beam is generated when a laser diode beam excites the Neodymium atoms in the rod material. When one atom which has been excited by the beam returns to its initial stable level, the energy difference between the two states is emitted as radiation in the form of a photon. When this photon meets another excited atom, emission of a second photon occurs. The second photon has the same phase, wavelength, and direction as the first photon. The light emitted in this manner oscillates between two mirrors. The light is amplified by this stimulated emission process and a 1064 nm output laser beam is produced. The frequency doubling process of the 1064 nm wavelength results when the infrared beam goes through a second harmonic crystal. The crystal is an optical dielectric that exhibits a non-linear optical response. The 532 nm wavelength is produced by harmonic generation of the 1064 nm laser beam.

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Table 1-1 Technical Specifications SPECIFICATION

CATEGORY Approximate Dimensions

Approximate Weight

Electrical Characteristics

Environmental Limitations

Width: 0.38 m (15.30 inches) Length: 0.45 m (17.75 inches) Height: 0.23 m (9.10 inches) 16.4 Kilos (36 lbs.) Voltage: 100-120 VAC / 220-240 VAC Current: 10 / 5 A Frequency: 50 / 60 Hz Fuse rating: 250V,Single Phase T6.3 Amps Insulation class: Class I, type BF, Intermittent use: 50% Duty cycle Operating: Temperature: Relative Humity:

15°C ≤ T°≤ 35°C 10% to 90% with no condensation

Storage:

-40°C ≤ T°≤ 70°C 10% to 90% with no condensation

Temperature: Relative Humity:

EyeLite® complies with CE MDD requirements.

Miscellaneous

Not suitable for use in the presence of flammable anesthetic, oxygen or nitrous oxide. System not protected against the ingress of water. Leakage current per IEC 601-1 is below 500 micro amps. Ground continuity per IEC 601-1 is below 0.1 ohm.

Table 1-2 Laser Characteristics CATEGORY

TREATMENT LASER BEAM

AIMING LASER BEAM

Laser Class

IV

II

• 30mW to 100mW in 10mW steps Laser Power

• 100mW to 1W in 20mW steps with additional steps at: 0.15, 0.25, 0.35, 0.45, 0.55, 0.65, 0.75, 0.85, 0.95

1mW maximum; adjustable by operator

• 1W to 1.7W (minimum) in 100mW steps Laser Wavelength

1-2

532 nm

approximately 670 nm

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CAUTION Canadian approval requires this supply system to be balanced, single-phase, two-pole system. Leakage exceeds 100 mA in an unbalanced system. EMC Statement: This equipment has been tested and found to comply with the limits for medical devices as specified in IEC 601-1-2:1993, EN60601-1-2:1994 and Medical Device Directive 93/42/ EEC. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. It is important to install and use the equipment in accordance with the instructions to prevent harmful interference to other devices in the surrounding area. You can determine whether or not the device is causing interference by turning it off and checking to see if the problem still exists. If this equipment does cause harmful interference to other devices, the user is encouraged to correct the interference by one or more of the following measures: • Reorient or relocate the other device(s). • Increase the separation between the equipment • Connect this equipment into an outlet on a circuit different from that to which the other device(s) are connected. • Consult the manu facturer or authorized field service technician for help. Environmental Issues: Follow local governing ordinances and recycling plans regarding disposal or recycling of device components.

WARNINGS! There are potential hazards when inserting, steeply bending, or improperly securing the fiberoptic. Not following the recommendations of the manufacturer may lead to damage to the fiber or delivery system and/or harm to the patient or user. Since the aiming beam passes down the same delivery system as the treatment beam, it provides a good method of checking the integrity of the delivery system. If the aiming beam spot is not present at the distal end of the delivery system, or its intensity is reduced or it looks diffused, this a possible indication of a damaged or not properly working delivery system. If there is any doubt, contact Alcon Technical Services. The use of flammable anesthetics or oxydizing gases such as nitrous oxide (N2O) and oxygen should be avoided. Some materials - for example cotton wool when saturated with oxygen - may be ignited by the high temperatures produced in normal use of the laser equipment. The solvents of adhesives and flammable solutions used for cleaning and disinfecting should be allowed to evaporate before the laser equipment is used. There is also danger of ignition of endogenous gases.

Universal Precautions: Universal precautions shall be observed by all people who come in contact with the instrument and/or accessories to help prevent their exposure to blood-borne pathogens and/or other potentially infectious materials. In any circumstance, wherein the exact status of blood or body fluids/tissues encountered are unknown, it shall be uniformly considered potentially infectious and handled in accordance with OSHA guidelines.

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WARNING LABELS Refer to Figure 1-2 for the location of warning labels on the EyeLite® console.

LASER YAG x 2 532 nm - 3.5W - CW DIODE LASER 660-680 nm - 1mW CLASS 4 LASER PRODUCT IEC 60601-2-22:1995

Figure 1-2 Warning Label Location Diagram

Underwriter's Laboratories The EyeLite® is classified by Underwriter's Laboratories Inc., with respect to electric shock, fire, mechanical, and other specified hazards only in accordance with UL2601-1, CAN/CSA 601.1, IEC 60601-2-22, and IEC 825.

1-4

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PREPARING FOR INSTALLATION Your Ophthalas® 532 EyeLite® was thoroughly inspected and carefully packaged for shipping. If the container is damaged, leave system in original container with packaging and request inspection by the carrier within 3 days of delivery. Initial installation must be performed by an Alcon Surgical representative. The following information will enable you to prepare the facility for installation of the EyeLite®. General Laser Room Layout The EyeLite® must be installed in a dust free room, and positioned so the laser beam cannot be directed toward a door, window, mirror, or reflective area. To reduce dust, avoid installing the instrument in a carpeted room. An example of a typical laser room layout is shown in Figure 1-3. Approximate dimensions of the EyeLite® console: Width (overall) = 0.38 m (15.30 inches) Length (overall) = 0.45 m (17.75 inches) Maximum height (overall) = 0.23 m (9.10 inches) Weight = 16.4 Kilos (36 lbs.) Approximate dimensions of the Slit Lamp table: Width (overall) = 0.74 m (29 inches) Length (overall) = 0.40 m (15.5 inches) Maximum height (overall) = 0.88 m (34.5 inches)

Slit Lamp and Table

- Emission Zone Limited access. Avoid doors, windows, mirrors, reflective surfaces.

Table (shown for illustrative purposes only) 1 meter minimum

1 meter (40") minimum EyeLite® Console

0.5 meter minimum

Figure 1-3 Recommended Laser Room Layout (Overhead View) 8065741078

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NOTE:

The accessory equipment connected to or used with this equipment must be certified according to the respective IEC standard; e.g., IEC 950 for data processing equipment (data processing equipment must not be used during patient treatment) and IEC 601-1 for medical equipment. Additionally, all configurations shall comply with the system standard IEC 601-1-1. Anyone connecting additional equipment or otherwise causing a different system configuration than provided by Alcon, is responsible for continued compliance to the requirements of the System Standard IEC 601-1-1. If in doubt, consult the Technical Services department of your local Alcon representative. It is recommended not to use a power strip to plug in accessory equipment. Each accessory should be plugged into a wall unit.

General Safety Precautions (Refer to IEC 825-1 or ANSI Z136.1) • A laser safety officer should be appointed to supervise the installation and use of the system. • Install an indicator light outside the laser room warning of instrument operation. • Position the instrument so that the laser beam is never directed toward a door, window or reflective surface. • Use a non-reflective matte finish wall paint. • Avoid covering laser room floor and walls with carpet or any other dust generating material. This will minimize the possibility of excess grime and dust on the instrument optics, and interference with equipment cooling. • The instrument requires a minimum of 0.5 meter of open space on all sides for proper cooling ventilation. Therefore, the system should be set flat, resting on the legs provided on the bottom of the console. • Unauthorized use of this laser should be prevented by key removal. • Entrances to areas or protective enclosures containing Class IV lasers should be posted with appropriate warning signs. • Appropriate eye protection must be used in all hazard areas. Use eye protection with OD 4 or above at 532 nm. Nominal Ocular Hazard Distance (NOHD) Accessory

Beam Divergence (NOHD)

LIO

0.024 radians (20 meters)

Slit Lamp

0.011 radians (40 meters)

Endoprobe

0.23 radians (3 meters)

• A qualified technician must verify that the power plug used is properly grounded. • The remote interlock connector should be connected to an emergency master disconnect interlock or to room/door/fixture interlocks. Please refer to figure 1-4. • The footswitch and the slitlamp adaptation/slitlamp should be placed within 2 meters of the EyeLite® Console.

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REMOTE CONNECT

2

CUSTOMER SUPPLIED DOOR SWITCH (OPTIONAL)

8

9-PIN D-CONNECTOR

9 1

TO DRIVE DOOR LAMP (OPTIONAL)

Figure 1-4 Remote Connector/Door Lamp Circuit Diagram

Universal Precautions Universal precautions shall be observed by all people who come in contact with the instrument and/or accessories to help prevent their exposure to blood-borne pathogens and/or other potentially infectious materials. In any circumstance, wherein the exact status of blood or body fluids/tissues encountered are unknown, it shall be uniformly considered potentially infectious and handled accordingly. This is in accordance with OSHA guidelines. Utility Requirements: Electrical requirement: The EyeLite® has an auto-ranging power supply which operates at 100-120 V and 220-240 V input ranges at 50/60 Hz. A properly grounded, standard plug is the only requirement. Electrical Connections

CAUTION Before turning the instrument ON for the first time after receipt of the system, wait one hour for the components and optics to normalize to avoid possible condensation that may have occurred during shipping. Use only <HAR> power cord with a minimum of 10 Amp rating. Before connecting the main plug verify that: • The Main Switch on the back panel is in the OFF (O) position. • The key is in the OFF (vertical) position, or has been removed. • The Remote Plug is connected on the Rear Panel. Optical Connections Optical connections vary in relation to the procedure to be performed. Different peripherals can be connected to the output port. These peripherals are: • Slit Lamp adaptation • Laser Indirect Ophthalmoscope • Endoprobe/Aspirating Endoprobe/Illuminated Endoprobe The procedures for connecting these peripherals are contained in Section Three: Operating Instructions. 8065741078

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EYELITE® SAFETY FEATURES The EyeLite® is designed for the highest degree of reliability and maximum safety for both the operator and the patient. Any abuse of this laser system may be dangerous. Before using the laser system, the operator must be familiar with the commands and the manipulation of this type of instrument. The EyeLite® is fitted with the following safety systems which must be understood by every operator: • A protective housing covers the laser source so that no harmful laser radiation will be emitted. No part of this protective housing should be removed by the operator. The laser system must not be used if the protective housing has been damaged or removed. • A remote connection (interlock) is located on the rear panel and permits the installation of an external switch. Refer to Figure 1-4 for remote switch connections. This switch can be installed on the laser room door and cuts off all laser emissions in case the door is opened during operation. There is also a Relay connector for connection to an internal relay to activate a door warning lamp if desired. • A key switch controls the laser power supply. Laser operation is not possible if the key has been removed. Access to the key should be limited to authorized and knowledgeable personnel. Do not leave key on or near instrument when not in use. • Laser status can be determined by visually checking the Ready and Standby LEDs. The green LED indicates that the system is in Standby mode. The red LED indicates that the system is in Ready mode and the laser is ready to fire. In addition, the system will emit a 4 millisecond beep and "*-------------------" will be displayed on the LCD display. • An emergency stop push button is mounted on the front panel. This button will cut off all laser emissions (treatment and aiming beam) at any time. The button must be pulled out to the initial position to restore power. • Laser firing commands are microprocessor controlled and firings are prevented should any malfunction be detected in the instrument electronics. The instrument will only fire when all conditions are correct. • Output power of the laser beam is continuously monitored and controlled. In case an unusual power condition is detected, firing is inhibited and treatment laser emission is cut off.

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PROFESSIONAL OPERATOR’S INFORMATION The following information is given to supplement the operator with specific information regarding the EyeLite® Ophthalmic Laser. Indications The EyeLite® is designed for use in the treatment of ophthalmic conditions including: Proliferative Diabetic Retinopathy, Macular Degeneration, and Retinal Detachment. Effects The laser beam is primarily absorbed by pigmented tissues within the eye. These primary pigments are hemoglobin/oxy-hemoglobin and melanin. In the case of macular treatment, xanthophyll pigment is involved. The surgeon controls the power, spot size, and exposure time of the delivered laser beam to the targeted tissue. It is the combination of these effects that results in the thermal action of the laser beam upon tissue. One or all of the adjustable parameters can be changed. However, in normal clinical practice, power is usually varied, and spot size and exposure time are preset as a function of the application. The 532 nm green laser beam has similar absorption characteristics to the 577 nm dye yellow laser beam7. This means that the absorption effects of the 532 nm wavelength are considerably higher in hemoglobin and melanin, and less in xanthophyll. In all cases, it is necessary to titrate laser parameters until the desired treatment results are obtained. The 532 wavelength also requires less power than that required with the argon laser to obtain similar results. Therefore, you should begin your titration levels with lower power than required for similar procedures with the argon laser.

WARNING! Failure to titrate delivered energy may result in patient injury.

Use of this medical laser, as with any other instrument, requires training and experience to obtain maximum clinical performance. Titrating the dosage is recommended by initiating a lesion formation in an area of normal retina with intact pigment epithelium. Power and exposure duration should be varied incrementally until the desired lesion is produced.

WARNING! If unsure which settings are required, select low power, short duration, and large spot size. Failure to do so may result in patient injury.

Delivery Of Laser Energy The laser beam is delivered to tissue via a Slit Lamp, Endoprobe, Illuminated Endoprobe, aspirating Endoprobe or Laser Indirect Ophthalmoscope (LIO). When using a Slit Lamp, the laser beam is often used in combination with various contact lenses to aid in treatment of particular targets such as the fundus. These contact lenses enable the laser beam to be directed to different sections of the eye.

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WARNING! Some contact lenses, generally classified as wide field or pan fundus lenses, magnify the laser spot incident upon them. For example, a pan retinal photocoagulation procedure is normally done with a spot size setting of 500 microns when using a three mirror lens. If a wide field lens were used, and the laser spot size setting remained at 500 microns, the actual spot in the eye would be larger than the indicated spot size setting. Normal increases in spot size in the eye range between 1.3 and 2 times the spot size as selected at the Slit Lamp zoom. These effects and resultant changes in power density, must be considered when using wide field lenses.

Reaction to applied laser energy by the eye is a function of many variables. The pigmentation of the eye, technique or procedure used, laser settings, and pre-existing condition of the eye, such as cataract, will have an effect on the selected laser parameters and the results obtained. Therefore, it is very important to consider all the existing clinical conditions and titrate until the desired results are obtained. Always use minimal illumination from the Slit Lamp while maintaining good visualization in order to reduce reflections and discomfort for the patient. Likewise, the aiming beam should be used at a minimum setting while maintaining proper targeting of the selected tissue. This will also minimize excessive reflections and scattering, particularly at smaller spot sizes. Dr. Safety Filter The wavelength of the green treatment beam is 532 nm, and 660 nm - 680 nm for the red aiming beam. The Dr. filter remains in the beam path during treatment, enabling the targeted tissue to be seen with complete protection for the operator. The filter has virtually no effect on visualization (colored view only). However, under certain conditions it may be desirable to remove the Dr. safety filter from the beam path for pre- or post-operative observation. Rotation of the filter in or out of the beam path is accomplished by means of a lever located on the right side of the filter. Note that the laser will not fire with the filter out of the beam path.

WARNING! Do not attempt treatment if aiming beam is not present. Patient injury may occur.

NOTE: The aiming beam passes down the same delivery system as the working beam; this provides a good method of checking the integrity of the delivery system. If the aiming beam spot is not present at the distal end of the delivery system, if its intensity is reduced, or if it looks diffused these are possible indications of a damaged or not properly working delivery system. Treatment Hazards A single treatment exposure will typically cause a blanching of target tissue. Exposure duration can be adjusted from 0.01 seconds to 2.0 seconds to result in the desired effect. A continuous treatment beam can also be selected. NOTE: In CW, depending on the thermal load of the system, the system may shut down in safety mode prior to the footswitch being released. Excessive combinations of power and exposure can cause undesirable tissue vaporization and charring. Reports1-6 indicate these hazards are no different from adverse effects from continuous wave argon lasers used at these same settings. No evidence of non-thermal effects has been observed. 1-10

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Contra Indications Patients with a condition that prevents visualization of target tissue (cloudy cornea, or extreme haze of the aqueous humor of the anterior chamber or vitreous humor) are poor candidates for Slit Lamp or LIO delivered laser treatment. Side Effects Corneal burns, inflammation, and transient elevations in intraocular pressure can occur as a result of ophthalmic laser treatment. Unintentional retinal burns can occur if excessive treatment beam power or duration are used. Laser Safety Back scattered radiation is of low intensity and is not harmful when viewed through a protective filter. All personnel in the treatment room must wear protective goggles, OD 4 or above at 532 nm, when the system is in Standby/Ready mode as well as during treatment. The Dr. filter is an OD greater than 4 at 532 nm.

WARNING! Use of controls or adjustments or performance of procedures other than those specified herein, may result in hazardous laser radiation exposure.

CAUTION Federal (USA) law restricts this device to sale by, or on the order of, a physician. 1 Ludwig, K.; Lasser, T.; Sakowski, H.; Abramwoski, H.; Worz, G. (Augenklinik,

Universitat Munchen) “Photocoagulation in the edematous and non-edematous retina with the cw-laser of different wavelengths.” Ophthalmologe (GERMANY), December 1994, Volume 91, No. 6, p783-788. 2 Roider, J.; Schiller, M.; el Hifnawi, E.S.; Birngruber, R. (Augenklinik, Medizinische

Universitat zu Lubeck) “Retinal photocoagulation with a pulsed, frequency-doubled Nd: YAG laser (532 nm).” Ophthalmologe (GERMANY), December 1994, Vol. 91 No. 6, p777-782. 3 Wyman, D.; Wilson, B.; Adams, K. (Medical Physics Department, Hamilton Regional

Cancer Centre, Ontario, Canada) “Dependence of laser photocoagulation on interstitial delivery parameters.” Lasers Surgical Medical (UNITED STATES), 1994, Vol. 14 No. 1, p59-64. 4 Obana, A.; Miki, T.; Matsumoto, M.; Ohtsuka, H.; Moriwaki, M.; Kamo, M.; Mii, T.;

Kijima, M. (Department of Ophthalmology, Osaka City University, Medical School, Japan) “An experimental and clinical study of chorioretinal photocoagulation using a frequency-doubled Nd: YAG laser.” Nippon Ganka Gakkai Zasshi (JAPAN), September 1993, Vol. 97 No. 9, p1040-1046. 5 Mordon, S.; Beacco, C.; Rotteleur, G.; Brunetaud, J.M. (INSERM - National Institute of

Health and Medical Research - Lille, France) “Relation between skin surface temperature and minimal blanching during argon, Nd-YAG 532, and CW dye 585 laser therapy of port-wine stains.” Lasers Surg Med (UNITED STATES) 1993, Vol. 13 No. 1, p124126. 6 Jalkh, A.E.; Pflibsen, K.; Pomerantzeff, O.; Trempe, C.L.; Schepens, C.L. (Eye Research

Institute of Retina Foundation, Boston, MA 02114) “A new solid-state, frequencydoubled neodymium-YAG photocoagulation system.” Arch Ophthalmol (UNITED STATES) June 1988, Vol. 106 No. 6, p 847-849. 7 “Wavelengths”, Opthamology, July 1986, Volume 93, Number 7, Page 956.

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