NIDEK INCORPORATED: 47651 Westinghouse Drive, Fremont, California 94539, U. S. A.
(United States Agent)Telephone: (510) 226-5700
Facsimile: (510) 226-5750
NIDEK SOCIETE ANONYME: Europarc 13, rue Auguste Perret, 94042 CRETEIL, France
(Authorized Representative)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 OPERA TOR’S MANUAL ONLY CONTAINS INFORMA TION TO
UNDERST AND THE OPERA TING PROCEDURES AND MAINTENANCE
OF THE INTEGRA TED/ATT ACHABLE SLIT LAMP DELIVER Y UNIT
(NIDEK SL-1800).
This manual contains information to understand the photocoagulation system that is comprised
when the NIDEK GREEN LASER PHOTOCOAGULA TOR 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 “”.)
Words in This Manual..................................................................................End of this manual
§
1
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.
INTRODUCTION
Photocoagulation unit
Motorized optical table
Fiber optic cable
Operator
GYC-1000
main body
Slit lamp SL-1800
Laser emission
Patient
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.
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).
1 - 2
[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
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
SAFETY
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 lar ge 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:
T emperature: 14 to 122 ºF (- 10 to 50 ºC) / Humidity: 10 to 95 % (non-condensing)
For installation:
T emperature: 50 to 86 ºF (10 to 30 ºC) / Humidity: 30 to 85 % (non-condensing)
• In transport of the photocoagulation system, observe the following instructions:
- T o 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)
- T o 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.
- T o avoid condensation, keep the change in temperature as little as possible.
2 - 2
CAUTION
• In installation of the photocoagulation system, observe the following instructions:
- T o 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.
- T o avoid adverse effect on the lens or mirror , do not install the photocoagulation system in a
high temperature, high humidity, or dusty environment.
- T o 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:
- T o 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.
- T o 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:
- T o avoid malfunction or electric shock, use a grounded power outlet which meets the power
requirements specified in the label on the main body .
- T o avoid malfunction or fire, do not overload the electrical outlet.
• In handling the connecting cable of the photocoagulation system, observe the following
instructions:
- T o avoid malfunction or failure of the system, connect the cable plug to the DELIVER Y
connector on the front panel of the main body .
• In handling the fiber optic cable, observe the following instructions:
- T o 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.
- T o 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 .
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.
- T o avoid hazardous radiation exposure, do not perform operation which is not described or
different from the procedure specified in the operator’s manual.
- T o avoid electric shock, do not modify nor touch the internal structure.
- T o maintain the performance of laser emission, never soil or scratch the lens or mirror .
• Before starting the photocoagulation system, observe the following instructions:
- T o avoid ignition or explosion from the laser emission, verify that there is no flammable
anesthetic gas in the operating room.
- T o 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: Y AG: D315-532
L8 YL DIN
(Produced by YAMAMOTO KOGAKU CO., L TD. Japan)
- To prevent accidents, perform the check following 5.3 Checks Before Use and 5.4Function 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.
2 - 3
• During operation of the photocoagulation system, observe the following instructions:
- T o 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.
- T o 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.
2 - 4
CAUTION
• In use of the slit lamp, observe the following instructions:
- T o 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.
- T o 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.
- W ipe 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
- T o avoid exposure to the reflected laser beam, verify that there is no reflective object in the
optical path before laser emission.
- T o 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.
- T o 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. V erify 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.
2.4 After Use Precaution, Maintenance, and Checks
CAUTION
• After use of the photocoagulation system, observe the following instructions:
- T o 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.
- T o 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:
- T o avoid accidents caused by improper repair of the system, only service technicians properly
trained by NIDEK may repair the system.
- T o 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.
2 - 5
• For check of the photocoagulation system, observe the following instructions:
- T o 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 .
- T o 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:
- T o avoid burn, replace the burned-out illumination lamp when it has been cooled enough.
- T o avoid troubles, use the illumination lamp of the specified rating.
- T o 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.
2 - 6
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]
T o 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. T o 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
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.
2 - 7
This label is not attached to
the product for the US market.
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
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.
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]
BlueBlue
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
Connecting cable
Magnification changer
Fixation lamp
Forehead rest
Eye level marker
Protective filter
Micromanipulator lever
Joystick
Chinrest
Hole for mounting the
focusing rod
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.