GYC-1000 Operators Manual May 2005

NIDEK CO., LTD. (Manufacturer) NIDEK CO., LTD (Tokyo Office)

NIDEK INCORPORATED (United States Agent) NIDEK SOCIETE ANONYME (Authorized Representative)

: 34-14, Maehama, Hiroishi-cho, Gamagori, Aichi 443-0038, Japan Telephone: (0533) 67-6611 Facsimile: (0533) 67-6610 : 6th Floor, Takahashi Bldg., No.2, 3-chome, Kanda-jinboucho Chiyoda-ku, Tokyo 101-0051, Japan Telephone: (03) 3288-0571 Facsimile: (03) 3288-0570 Telex: 2226647 NIDEK J : 47651 Westinghouse Drive, Fremont, California 94539, U. S. A. Telephone: (510) 226-5700 Facsimile: (510) 226-5750 : Europarc 13, rue Auguste Perret, 94042 CRETEIL, France Telephone: (01) 49 80 97 97 Facsimile: (01) 49 80 32 08 2005. 5 17102-P902B Printed in JAPAN

BEFORE USE OR MAINTENANCE OF THE PHOTOCOAGULATION SYSTEM, READ THIS MANUAL AND OPERATOR’S MANUAL OF THE MAIN BODY. THIS OPERATOR’S MANUAL ONLY CONTAINS INFORMATION TO UNDERSTAND THE OPERATING PROCEDURES AND MAINTENANCE OF THE INTEGRATED/ATTACHABLE SLIT LAMP DELIVERY UNIT (NIDEK SL-1800). This manual contains information to understand the photocoagulation system that is comprised when the NIDEK GREEN LASER PHOTOCOAGULATOR Model GYC-1000 (main body) is connected with the INTEGRATED/ATTACHABLE SLIT LAMP DELIVERY UNIT (NIDEK SL-1800). This manual provides general descriptions of the photocoagulation system, cautions for safety, specifications, accessories, operating procedures, and maintenance procedures. As for the detailed operating procedures of the main body or other optional delivery units, refer to the particular operator’s manual. IEC 60601-1 is applied to the contents described in this manual. To understand how to correctly use the photocoagulation system, this manual and the operator’s manual of the main body are needed. Especially, cautions for safety and operating procedures should be understood thoroughly before using the laser system. Be sure to store this manual with the main body and refer to it whenever necessary. Use of the photocoagulation system is limited to the treatment of eye disease by qualified physicians only. The physicians are responsible for the application of the photocoagulation system and the technical selection of the treatment of various eye diseases. If you find any problems during, or have any questions about operation, please contact NIDEK or your authorized distributor.

[Note on display of the exposure time and the interval time (in the repeat mode)] When the exposure time or the interval time (in the repeat mode) on the display of the control box of the GYC-1000 is less than “1.00” or “1.0”, “0” before the decimal point is displayed small. (Example: if the setting is “0.30”, the display shows “ ”.)

Table of Contents

§1 INTRODUCTION ...Page 1-1 1.1 Outline of the Slit Lamp Delivery Unit ... 1-1 1.2 Indications for Use ... 1-2 1.3 Classifications of the Slit Lamp Delivery Unit ... 1-2 1.4 Symbol Information ... 1-3

§2 SAFETY ... 2-1 2.1 Storage, Transport, and Installation Precautions ... 2-1 2.2 Wiring and Connection Precautions ... 2-2 2.3 Usage Precautions ... 2-3 2.4 After Use Precaution, Maintenance, and Checks ... 2-5 2.5 Disposal ... 2-6 2.6 Safety Devices ... 2-6 2.7 Nominal Ocular Hazard Distance (NOHD) ... 2-6 2.8 Labels ... 2-7

§3 SYSTEM DESCRIPTION ... 3-1 3.1 NIDEK SL-1800 Integrated Delivery Unit ... 3-1 3.2 NIDEK SL-1800 Attachable Delivery Unit ... 3-5 3.3 Common Accessories of the Integrated and Attachable Delivery Units ... 3-7 3.4 Options ... 3-8

§4 INSTALLATION, STORAGE, AND TRANSPORT ... 4-1 4.1 Installation ... 4-1 4.1.1 Configuring the slit lamp delivery unit ... 4-1 4.1.2 Installing the photocoagulation system ... 4-4 4.1.3 Optical adjustment ... 4-9 4.2 Storing the Attachable Delivery Unit ... 4-12 4.3 Transporting the Integrated Delivery Unit ... 4-17

§5 OPERATING PROCEDURES ... 5-1 5.1 Operation Flow ... 5-1 5.2 Starting the Photocoagulation System ... 5-2 5.3 Preparing for Laser Emission ... 5-3 5.4 Laser Emission ... 5-7 5.5 Indications of Misoperation ... 5-11 5.6 Emergency Stop ... 5-11

§6 MAINTENANCE ... 6-1 6.1 Replacing the Fuses ... 6-1 6.1.1 For the motorized optical table ... 6-1 6.1.2 For the slit lamp power supply ... 6-2 6.2 Replacing the Illumination Lamp ... 6-3 6.3 Replacing the Fixation Lamp ... 6-4 6.4 Indication of Failure of the Slit Lamp Power Supply ... 6-5 6.5 Cleaning ... 6-6 6.5.1 Cleaning the exterior ... 6-6 6.5.2 Cleaning the optical parts ... 6-6 6.5.3 Cleaning the fiber optic cable ... 6-7

§7 SPECIFICATIONS AND CONFIGURATION ... 7-1 7.1 Specifications ... 7-1 7.2 Standard Configuration ... 7-3 7.2.1 Standard configuration for the integrated delivery unit ... 7-3 7.2.2 Standard configuration for the attachable delivery unit ... 7-3 7.3 Options ... 7-3 Words in This Manual...End of this manual

§1 INTRODUCTION 1.1 Outline of the Slit Lamp Delivery Unit This delivery unit is connected to the NIDEK GREEN LASER PHOTOCOAGULATOR, Model GYC-1000 (main body) to comprise the photocoagulation system and to treat affected areas using the slit lamp, NIDEK SL-1800. The integrated delivery unit which incorporates the SL-1800 comprises the photocoagulation system in connection with the GYC-1000 main body. The attachable delivery unit is mainly the photocoagulation unit and the protective filter unit. They are attached to your slit lamp (NIDEK SL-1800) to comprise the integrated delivery unit. The comprised integrated delivery is connected to the GYC-1000 to comprise the photocoagulation system. This photocoagulation system allows the operator to select between photocoagulation with the green laser beam (wavelength: 532 nm) and observation of the affected area with the slit lamp. Photocoagulation unit

Fiber optic cable

Slit lamp SL-1800

Laser emission Patient

Operator

GYC-1000 main body

Motorized optical table

Foot switch <Front view>

<Right side view>

CAUTION • United States Federal law restricts this device to sale by or on the order of a physician.

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1.2 Indications for Use The Nidek Green Laser Photocoagulator Model GYC-1000 Integrated/Attached Slit Lamp Delivery Unit is intended to be used in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

1.3 Classifications of the Slit Lamp Delivery Unit [Classification under the provision of 93/42/EEC (MDD)] Class IIb As long as this delivery unit is connected to the main body, this delivery unit is classified as a Class IIb unit. [Class of the laser system] Class 4 As long as this delivery unit is connected to the main body, this unit is classified as a Class 4 system. A Class 4 laser is capable of producing injuries to the eye with direct laser exposure, or by diffuse reflections (0.5 W or more). [Protection method against electric shock] Class I As long as this delivery unit is connected to the main body, this delivery unit is classified as a Class I system. A Class I system is a system in which the protection against electric shock does not rely on basic insulation only, but which includes an additional safety precaution in such a way that means are provided for the connection of accessible conductive parts to the protective (earth) conductor in the fixed wiring of the installation in such a way that accessible conductive parts cannot become live in the event of a failure of the basic insulation. [Degree of protection against electric shock] Type B applied part As long as this delivery unit is connected to the main body, this delivery unit is classified as a system with a Type B applied part. A system with a Type B system provides an adequate degree of protection against electric shock particularly regarding; - allowable leakage currents - reliability of the protective earth connection (if present) [Degree of protection by the enclosure] This delivery unit is classified as a IP20. An IP20 system is protected against an ingress of solid foreign objects, such as a finger having a diameter of 12.5 mm or greater. However, it is an ordinary system without protection against an ingress of liquids. Be careful not to expose water to this delivery unit. [Sterilization methods recommended by the manufacturer] This delivery unit does not have any part to be sterilized or disinfected.

1-3 [Degree of safety in the presence of flammable anesthetics and/or flammable cleaning agents] This delivery unit should be used in an environment where no flammable anesthetics and/or flammable cleaning agents are present. [Mode of operation] As long as this delivery unit is connected to the main body, this unit is an intermittent operating system. * During use of the slit lamp, care should be taken not to let the lamp house be excessively heated by continuous use of the illumination of high intensity.As a guideline, if the illumination of the maximum intensity is used for 10 minutes, turn off the illumination and wait for 20 minutes to cool the lamp house. [Classification by transportability] This delivery unit is classified as the transportable system.

1.4 Symbol Information This symbol indicates the master switch setting. When the switch is in this position, the power is not supplied to the photocoagulation system. This symbol means that the system is classified as a system with a type B applied part. This symbol indicates that important descriptions related to operation or maintenance are contained in the operator’s manual and that an operator must refer to the operator’s manual prior to operation and maintenance.

§2 SAFETY In this manual, signal words are used to designate the degree or level of safety alerting. The definitions are as follows. WARNING: Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. CAUTION: Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury or in a property damage accident. Even situations indicated by WARNING and CAUTION may result in serious injury under certain conditions. Safety precautions must be strictly followed at all times.

2.1 Storage, Transport, and Installation Precautions CAUTION • In storage, transport, and installation, verify that the following conditions are met: - Not exposed to direct sunlight or ultraviolet rays - Not exposed to rain or water - No chemicals or organic solvents are present - No poisonous gas, sulfur, salt, or large amount of dust is contained in the air - Level and stable without vibration and shock - The following are the specified environmental conditions for storage and transport (packed condition), and installation (unpacked condition) For storage and transport: Temperature: 14 to 122 ºF (- 10 to 50 ºC) / Humidity: 10 to 95 % (non-condensing) For installation: Temperature: 50 to 86 ºF (10 to 30 ºC) / Humidity: 30 to 85 % (non-condensing) • In transport of the photocoagulation system, observe the following instructions: - To avoid injury or malfunction, remove the delivery unit from the main body and store them in the carrying case or shipping carton (keep the shipping carton used for delivery) - To avoid shift of the optical axis, do not subject the main body or the delivery unit of the combination system to physical shock even if they are packed in the carrying case or shipping carton. - To avoid condensation, keep the change in temperature as little as possible.

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CAUTION • In installation of the photocoagulation system, observe the following instructions: - To avoid troubles from condensation, let the photocoagulation system sit until the condensation has dissipated before installation. - To avoid malfunction from change in temperature and condensation, do not install the photocoagulation system where it is exposed to the direct flow of air conditioning. - To avoid adverse effect on the lens or mirror, do not install the photocoagulation system in a high temperature, high humidity, or dusty environment. - To let the photocoagulation system dissipate heat properly, install it so that the air vent on the rear panel and the wall or the foreign object are more than 10 cm apart. • Attach or remove the delivery unit to the main body with the key switch off ( ). If the delivery unit is attached ore removed with the key switch on ( ), an error may occur.

2.2 Wiring and Connection Precautions CAUTION • In handling the power cord and cables, observe the following instructions: - To avoid short circuit or fire from broken wire, perform the connection and disconnection holding the plug, and do not coil the power cord and connecting cables forcefully in a short curvature, or crush or pinch them with heavy objects. - To avoid short circuit or fire, replace the broken wire with a new one. - Never pull the power cord or a connecting cable to transport the system. • In handling the power cord, observe the following instructions: - To avoid malfunction or electric shock, use a grounded power outlet which meets the power requirements specified in the label on the main body. - To avoid malfunction or fire, do not overload the electrical outlet. • In handling the connecting cable of the photocoagulation system, observe the following instructions: - To avoid malfunction or failure of the system, connect the cable plug to the DELIVERY connector on the front panel of the main body. • In handling the fiber optic cable, observe the following instructions: - To avoid damage or deterioration in laser delivery performance, do not let any part of the fiber optic cable bend with a radius of 10 cm (4.5 in) or more. - To avoid deterioration in laser delivery performance, be careful not to soil or damage the tip of the plug of the fiber optic cable plug, especially when inserting the plug into the FIBER connector. - Connect the cable plug to the FIBER connector on the front panel of the main body.

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2.3 Usage Precautions WARNING • Use of controls or adjustments, or performance of procedures other than those specified herein may result in hazardous radiation exposure. • In handling of the delivery unit, observe the following instructions: - Only service technicians properly trained by Nidek may install and configure the photocoagulation system. Only qualified physicians may perform emission of the green laser for treatment. - To avoid hazardous radiation exposure, do not perform operation which is not described or different from the procedure specified in the operator’s manual. - To avoid electric shock, do not modify nor touch the internal structure. - To maintain the performance of laser emission, never soil or scratch the lens or mirror. • Before starting the photocoagulation system, observe the following instructions: - To avoid ignition or explosion from the laser emission, verify that there is no flammable anesthetic gas in the operating room. - To protect the eyes of personnel in the operating room, instruct them to wear recommended safety goggles (or the equivalent) before the operation and not to look at the laser beam directly during the operation. Recommended goggles ... Model YL-300 for frequency doubled Nd: YAG: D315-532 L8 YL DIN (Produced by YAMAMOTO KOGAKU CO., LTD. Japan) - To prevent accidents, perform the check following 5.3 Checks Before Use and 5.4 Function Checks (p. 5-3) in the operator’s manual of the main body and record each result in the list (p. 5-5) when starting operation of the photocoagulation system. • During operation of the photocoagulation system, observe the following instructions: - To avoid unintended exposure to the laser beam, do not gaze at the aiming beam that is emitted from the laser aperture or direct it toward personnel. Always pay attention to the direction in which it is emitted. - To avoid accident caused by unauthorized personnel, do not leave the photocoagulation system unattended while it is operational. If the operator has to be away from the system, turn the key switch to the off position, remove the key, and store it in the customary place. • During operation of the photocoagulation system, observe the following instructions: - Do not use the photocoagulation system simultaneously with other electronic equipment to avoid electromagnetic interference with the action of the system - Do not use the photocoagulation system simultaneously in the same room with other equipment such as a life-support equipment that has serious effects on the life of patient and the treatment, or other measurement or treatment equipment that involves small signal. - Do not use cables and accessories that are not specified for the photocoagulation system because that may deteriorate the electromagnetic compatibility. - Do not use the photocoagulation system simultaneously with portable radio frequency communication systems because it may have an adverse effect on the system.

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CAUTION • In use of the slit lamp, observe the following instructions: - To avoid damage to the retina of the patient, only trained physician may perform observation using the slit lamp. Do not emit unnecessarily intense laser beam. - To avoid the blue hazard, set the illumination for observation to the minimum level initially, and then increase it until the desired intensity can be obtained. After the observation, lower the illumination intensity to the minimum level again. - Wipe the forehead rest, the chinrest, and the grips of the slit lamp every time before observing a patient to keep them clean. • For laser emission, observe the following instructions: - When the green laser beam (wavelength: 532 nm) of the GYC-1000 is emitted into tissue, following symptoms may occur. Pay attention to the direction of the aiming beam to avoid emitting the laser beam into the eye or onto skin inadvertently. - Skin symptoms ... Damage to the cornea, etc. or blindness - Eye symptoms ... Pain or burn - To avoid exposure to the reflected laser beam, verify that there is no reflective object in the optical path before laser emission. - To avoid excessive reaction, set the laser to a low output power initially, and then increase it until the desired effect can be obtained. Always set the output power to the minimum after the laser emission. - To avoid damage to the cornea or the crystalline lens, if the indirect lens is used for laser emission, take the magnification into consideration and take care not to make the spot size larger than approximately 200 µm. - To avoid exposure to the accidentally emitted laser beam, always place the photocoagulation system in the condition in which the laser cannot be emitted (standby mode) except when emitting the laser. - Confirm that the photocoagulation system is in a proper condition for laser emission by the following procedures: (if any abnormality is found in step 2, ask Nidek for check and adjustment. 1. Project the aiming spot on an even surface that is not specular. 2. Verify that the intensity of the illumination spot is even around the center as shown in the figure on the right and that lowering of the intensity or vignetting does not occur. • When the green laser beam is emitted in photocoagulation using the slit lamp, the color of the green laser beam can be seen slightly in the view field occasionally. This occurs when the beam that is reflected from the contact lens enters the optical system for observation. The symptom differs according to the type of contact lens, and condition in which the green laser beam enters the contact lens. The light intensity is attenuated to a safe level by the protective filter that is incorporated in the slit lamp. If an intense light is seen, stop the use of the system immediately, and ask NIDEK for checking of the system.

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2.4 After Use Precaution, Maintenance, and Checks CAUTION • After use of the photocoagulation system, observe the following instructions: - To avoid the tracking phenomenon, if the system will not be used for a long period of time, disconnect the power cord from the grounded power outlet. - To maintain the performance of laser emission, when the photocoagulation system is not being used, turn off the power and put dust cover over it. • For maintenance of the photocoagulation system, observe the following instructions: - To avoid accidents caused by improper repair of the system, only service technicians properly trained by NIDEK may repair the system. - To maintain the performance of laser emission, take care not to scratch or accumulate dust on the optical parts such as lens and mirror. - To protect the exterior or maintain the operability of the system, do not use organic or abrasive solvents for cleaning. • For check of the photocoagulation system, observe the following instructions: - To maintain the performance of laser emission, ask NIDEK or your authorized distributor for calibration of output power and exposure time of the laser beam, and for measurement of the earth resistance and leakage current once a year. - To avoid infection, wipe the surface of the delivery unit (especially the inside parts of the headband and overband) with a clean cloth dampened with alcohol before returning it to NIDEK for repair or maintenance. • In replacing the illumination lamp of the slit lamp, observe the following instructions: - To avoid burn, replace the burned-out illumination lamp when it has been cooled enough. - To avoid troubles, use the illumination lamp of the specified rating. - To avoid reduction of life time of the lamp, do not touch the glass part of it with bare hands. If the glass part is touched with bare hands, wipe the part with a clean cloth dampened with alcohol.

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2.5 Disposal CAUTION • When disposing of the delivery unit, follow the local governing ordinances and recycling plans. (For details, ask NIDEK or your authorized distributor.) • When disposing of packing materials, sort them by material and follow local governing ordinances and recycling plans. • When disposing of the GYC main body and the Slit lamp, see the operator’s manual for each.

2.6 Safety Devices [LASER EMISSION indicator] During the photocoagulation system operation (while the key switch is in the ON ( ) position), the LASER EMISSION indicator on the slit lamp delivery unit lights up to call the operator’s attention. [Protective filter] To protect the operator’s eye from the reflected light of the green laser beam, “electrically powered” protective filter is available. If the filter is not set in the observation optical path when the foot switch is pressed to emit the green laser beam, “Err2” indication appears on the control box. [Manual reset function] After the photocoagulation system is stopped due to the stop signal from the remote connector, the line power being cut, or an unintended cause, etc., the system does not restart automatically even when all the problems are solved and the system is ready to be restarted. It depends on the operator’s decision whether to restart the system or not. To restart the system, turn the key switch to the OFF ( ) position (manual reset), and then to the ON ( ) position again.

2.7 Nominal Ocular Hazard Distance (NOHD) The nominal ocular hazard distance (NOHD) of the laser beam of the slit lamp delivery unit is as follows: NOHD = 14.6 m

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2.8 Labels In order to call the operator’s attention, the appropriate warning labels are attached to the specified locations on the slit lamp delivery unit.

[For the US market]

[For 100V area]

This label is not attached to the product for the US market.

[For the French market and 200V area]

§3 SYSTEM DESCRIPTION 3.1 NIDEK SL-1800 Integrated Delivery Unit [SL-1800 Integrated Delivery Unit: Physician’s side]

Fiber optic cable

Fiber optic cable guide

Emission indicator

Chinrest elevation control Illumination control

Grip

Power switch

UP and DOWN lever for motorized optical table

Master switch

[SL-1800 Integrated Delivery Unit: Slit/filter operation part]

Slit width control Slit rotation control

Slit length control

Filter selector

3-2 Master switch Used to turn on or off the power of the slit lamp and motorized optical table. UP and DOWN lever for motorized optical table Used to move the motorized optical table up and down. When the lever is raised, the table moves up. When it is lowered, the table moves down. Power switch Used to turn on or off the power of the slit lamp. When it is turned on, the switch lights up. Grip Have the patient hold the grips to keep him/her in a stable posture. Chinrest elevation control Used to adjust the vertical position of the patient’s chin. Emission indicator Lights when the key switch of the main body is turned to the on ( ) position.

Fiber optic cable guide Lightens the load of the fiber optic cable on itself when it runs from the main body to the slit lamp delivery unit. Illumination control Used to adjust the intensity of the illumination light of the slit lamp. It can be changed continuously. Slit width control Used to adjust the slit width. The slit width can be changed continuously in the range from 0 to 16 mm. Slit length control The upper ring is the slit length control. Turning this ring changes the slit length to 0.4, 6.5, 10.5, 16, or continuously in the range from 2 to 14 mm. Filter selector The lower ring is the filter selector. The following filters can be selected by turning this ring. [Index] [Filter] [Purpose] Blue Blue Fluorescence and color exciter

Fiber optic cable Delivers the laser beam from the main body to the delivery unit. Its plug is connected to the FIBER connector on the main body. * Handle the fiber optic cable with care because optical fiber runs inside it.

Green Red White

Red-free Heat absorb Free aperture

Red-free Heat absorb -------

Slit rotation control The part indicated with the bracket in the figure on the left page moves 90º to left and right each. Moving it rotates the slit up to 90º in the horizontal direction from the vertical direction. It clicks when the slit becomes vertical.

3-3 [Side view]

Spot size control Fixation lamp Connecting cable Forehead rest Magnification changer

Eye level marker

Protective filter

Chinrest

Micromanipulator lever

Hole for mounting the focusing rod

Joystick

Base fixing knob

Fuse holder

Illumination focusing plates

3-4 Joystick Used to move the slit lamp. The slit lamp moves up and down by rotating the joystick. The slit lamp moves horizontally by sliding it side to side or back and forth. In addition, the horizontal fine movement of the slit lamp can be performed by tilting it. Micromanipulator lever Used for fine positioning of the aiming beam spot and green laser beam. When this lever is released, the spot is returned to the center of the visual field. Protective filter Used to protect the operator’s eye against a reflected laser beam from a target tissue. Magnification changer Used to change the magnification of the microscope. [Magnification] [Actual visual field] 32× φ 7.5 mm 20× φ 11.5 mm 12.5× φ 18.4 mm 8× φ 29.5 mm 5× φ 46.0 mm Connecting cable Its connector is connected to the DELIVERY connector on the connector panel of the main body. Spot size control Used to adjust the spot size of the laser beam in the range between 50 and 990 µm. The spot size is indicated on the control box of the main body.

Fixation lamp Used to fix the patient’s visual axis by adjusting its arm. Forehead rest Patient’s forehead rests on this forehead rest. Eye level marker The patient’s eyes are aligned to this height. Chinrest Patient’s chin is placed on this. Hole for mounting the focusing rod Remove the cap and insert the end of the focusing rod. If the focusing rod is not used, cover the hole with the cap.

Base fixing knob Used to fix the horizontal movement of the slit lamp by tightening this. Fuse holder The holder to set the fuses of the motorized optical table. Fuse rating: <100V area> 250 VAC, T 6A <200V area> 250VAC, T 3.15A * As for the replacement of fuses, see [6.2.1 For the motorized optical table] (p. 6-2). Illumination focusing plates Used to adjust the focus of the illumination light. Loosen the screws on the plates and move the plates vertically for the adjustment. When the proper focus is achieved, tighten the screws.

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3.2 NIDEK SL-1800 Attachable Delivery Unit [SL-1800 Integrated Delivery Unit: Photocoagulation Unit] <Photocoagulation unit - left side>

Retaining knob Filter connector

Laser reflective mirror

Micromanipulator lever

[SL-1800 Integrated Delivery Unit: Slit/filter operation part] <Photocoagulation unit - Physician’s side> Fiber optic cable guide

Fiber optic cable

Spot size control

Emission indicator

Connecting cable