Professional Documents
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OPERATOR’S MANUAL
(SUPPLEMENT TO GYC-1000 OPERATOR’S MANUAL)
NIDEK CO., LTD. : 34-14, Maehama, Hiroishi-cho, Gamagori, Aichi 443-0038, Japan
(Manufacturer) Telephone: (0533) 67-6611
Facsimile: (0533) 67-6610
NIDEK CO., LTD : 6th Floor, Takahashi Bldg., No.2, 3-chome, Kanda-jinboucho
(Tokyo Office) Chiyoda-ku, Tokyo 101-0051, Japan
Telephone: (03) 3288-0571
Facsimile: (03) 3288-0570
Telex: 2226647 NIDEK J
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
2005.3
17120-P902B
Printed in JAPAN
BEFORE USE OR MAINTENANCE OF THE PHOTOCOAGULATION
SYSTEM, READ THIS MANUAL AND OPERATOR’S MANUAL OF THE
MAIN BODY.
The Operator’s Manual contains information necessary for the operation of the
photocoagulation system that is comprised when the NIDEK GREEN LASER
PHOTOCOAGULATOR Model GYC-1000 (main body) is connected with the
BINOCULAR INDIRECT OPHTHALMOSCOPE (hereafter called B.I.O.) DELIVERY
UNIT (Keeler All Pupil II TYPE). Refer to the applicable operating manual for the operating
procedures of photocoagulation using other devices.
This manual includes the operating procedures, cautions for safety, specifications and
maintenance instructions.
This manual complies with IEC 60601. This manual and the operator’s manual for the main
body are required to correctly use the photocoagulation system.
Especially, the cautions for safety and operating procedures must be thoroughly
understood before using the instrument. Keep this manual handy to verify use whenever
necessary.
Use of this system is limited to the treatment of eye disease by qualified physicians
only.
The physicians are responsible for the application of this photocoagulation system and
the treatment of various eye diseases.
If you encounter any problems or have questions about the instrument, 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 B.I.O. Delivery Unit .............................................................................. 1-1
1.2 Indications for Use ..................................................................................................... 1-1
1.3 Classifications of the B.I.O 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 Precautions, Maintenance, and Checks ........................................................ 2-5
2.5 Disposal ..................................................................................................................... 2-5
2.6 Safety Devices ........................................................................................................... 2-6
2.7 Nominal Ocular Hazard Distance (NOHD) ................................................................. 2-6
2.8 Labels ........................................................................................................................ 2-7
§3 DEVICE DESCRIPTION ............................................................................................. 3-1
§4 INSTALLATION AND STORAGE ............................................................................. 4-1
4.1 Installing the System ................................................................................................... 4-1
4.2 Storing the System ...................................................................................................... 4-6
4.2.1 Storing the main body ........................................................................................ 4-6
4.2.2 Storing the B.I.O. delivery unit ......................................................................... 4-11
§5 OPERATING PROCEDURES ..................................................................................... 5-1
5.1 Staring the Photocoagulation System ........................................................................... 5-1
5.2 Preparing for Laser Emission ...................................................................................... 5-3
5.3 Laser Emission ........................................................................................................... 5-6
5.4 End of Operation ...................................................................................................... 5-11
5.5 Indications of Misoperation ....................................................................................... 5-12
5.6 Emergency Stop ....................................................................................................... 5-12
§6 MAINTENANCE .......................................................................................................... 6-1
6.1 Replacing the Illumination Lamp .................................................................................. 6-1
6.2 Cleaning ..................................................................................................................... 6-2
6.2.1 Cleaning the optical parts ................................................................................... 6-2
6.2.2 Cleaning other parts .......................................................................................... 6-2
6.2.3 Cleaning the fiber optic cable ............................................................................. 6-3
§7 SPECIFICATIONS AND CONFIGURATIONS ......................................................... 7-1
7.1 Specifications ............................................................................................................. 7-1
7.2 Standard Configurations ............................................................................................. 7-2
7.3 Options ...................................................................................................................... 7-2
B.I.O Operator
Fiber-optic cable
antenna (option)
Fiber-optic cable
Laser emission
Foot switch
CAUTION
• United States Federal law restricts this device to sale by or on the order of a physician.
[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 continuous operating
system.
[Classification by transportability]
This delivery unit is classified as a transportable system.
1-3
This symbol indicates that important descriptions are contained in the operator’s manual and
that the operator must refer to the operator’s manual prior to operation or maintenance.
§2 SAFETY
In this manual, signal words are used to designate the degree or level of safety alerting. The
definitions are as follows.
Even situations indicated by WARNING and CAUTION may result in serious injury
under certain conditions. Safety precautions must be strictly followed at all times.
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 unit 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.
• In handling the illumination cable and the AC adapter cable, observe the following instructions:
- To avoid malfunction or failure of the system, connect the cable plugs to the connector at the
bottom of the wall pack securely.
WARNING
• In use of the B.I.O. delivery unit, observe the following instructions:
- To avoid damage to the retina of the patient, only trained physician may perform observation
using the B.I.O delivery unit. 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.
CAUTION
• 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 exposure to the accidentally emitted laser beam, always place the laser 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 a 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.
2-5
2.5 Disposal
CAUTION
• When disposing of the B.I.O. 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.
2-6
* In this operator’s manual, W.D. (working distance) means the distance between the eyepiece lens
of the B.I.O. and the 20D aspheric B.I.O. lens.
2-7
2.8 Labels
In order to call the operator’s attention, the appropriate warning labels are attached to the specified
locations on the delivery unit.
2-8
Observation window
Fiber-optic cable
Illumination cable
Illumination control
Carrying case
Store the B.I.O. delivery unit in this carrying case
for transfer or when it will not be used for a long
period of time.
Stand
[Option]
• Handle the fiber optic cable of the B.I.O. delivery unit with special care.
Not only coiling the fiber optic cable with a radius of 10 cm (4.5 in) or less, but also
physical shock may deteriorate the laser delivery performance.
1. Secure the power source and the installation place for the photocoagulation system.
1) Prepare a wagon or the equivalent that is at least 60cm wide and 40cm deep (recommended).
* Lock the casters if possible.
CAUTION
• Confirm that the surface on which the prepared wagon or the equivalent is placed is level and
stable.
Otherwise, the main body or the B.I.O. delivery unit on the stand may fall during use of the
photocoagulation system.
2) Confirm that the power outlet to be used is grounded and meets the power requirements labeled
on the main body.
CAUTION
• If the power outlet does not meet the power requirements labeled on the main body, the
system may not perform sufficiently, and be damaged. If the power outlet is not grounded
and current leakage occurs due to malfunction, electric shock may result.
4-2
2. Install the main body.
2) Place the main body on the wagon or the equivalent prepared in step 1.
* Leave the room for the B.I.O. delivery unit.
CAUTION
• Install the main body so that its rear panel is at least 10cm apart from the wall.
Blocking the release of heat from the laser may damage the main body.
1) Take the stand and the AC adapter out of the carrying case and place them on the wagon or
another convenient place.
Stand
4-3
4. Connect the cables to the rear panel of the main body.
Short plug
Connect the cable plug of the foot switch to the FOOT SW connector on the rear panel.
3) Connect the short plug or plug of the external switch to the REMOTE connector.
Align the short plug or plug of the external switch with the REMOTE connector on the rear panel.
While holding both sides of the plug, insert the plug to the connector as far as it goes.
1) Connect the short plug of the B.I.O. delivery Plug of the fiber-optic cable
unit to the DELIVERY connector on the control
panel.
CAUTION
• Pay attention to the handling of the fiber optic
cable so that it is not coiled in a radius of less
than 10 cm. 10 cm or more
The transmittancy of the laser beam may
be reduced or the optical fiber may be
damaged.
6. Connect the power cord and the AC adapter to the power outlet.
Connect the power cord of the main body and the AC adapter of the wall pack to the power outlet
verified in step 1.
2) Insert the key into the key switch and turn it to Master switch
the on ( ) position.
“ ” “ ”
Key switch
Perform the check referring to [5.4 Function Checks] (p. 5-3) in the Operator’s Manual of the
main body.
* Record each result in [5.5 Function Check List] (p. 5-6) in the same Operator’s Manual.
4-5
9. Hang the B.I.O. delivery unit on the stand.
Hold the headband of the B.I.O. delivery unit with one hand while holding the connecting cable and
the fiber optic cable with the other.
Hang the height adjustment knob for the headband on the hanger. Then place the connecting cable
and the fiber optic cable on the table while coiling them so that they are not strained.
Illumination control
1) Turn the illumination control of the B.I.O.
delivery unit to the minimum (not off).
* Turning the illumination control in the direction
indicated with an arrow in the figure on the
right decreases the intensity of the illumination.
3) Turn the key switch of the main body to the off ( ) position.
11. Remove the key from the main body and store it in a customary place.
13. Put the dust cover or the equivalent over the B.I.O. delivery unit.
1) Disconnect the fiber optic cable. Plug of the fiber optic cable
CAUTION
10 cm or more
• Pay attention to the handling of the fiber optic
cable so that it is not coiled in a radius of less
than 10 cm.
The transmittancy of the laser beam may
be reduced or the optical fiber may be
damaged.
Short plug
1) Remove the short plug or plug of the external switch signal line from the REMOTE connector.
Remove the short plug or plug of the external switch signal line from the REMOTE connector.
(When the signal line of the external switch is used, coil the cable in an appropriate diameter and
bind it.)
Place the short plug or plug of the external switch signal line temporarily where it will not be an
obstruction.
Hold the plug and remove the cable plug from the FOOT SW connector.
Coil the cable in a diameter a little larger than the width of the cover, and put it in the cover.
Hold the plug and remove the power cord from the grounded power outlet.
Remove the female plug of the power cord from the inlet.
Coil the power cord in an appropriate diameter and bind it with the attached strap.
4-8
3. Store the accessories in the accessory box. Divider
4) Close the lids of the accessory box and seal it Control panel
with packing tape. Bubble bag
Special pad
Bottom pad
External box
4 - 10
1) Disconnect the plug of the power cord of the AC adapter from the power outlet.
2) Tighten the circumference and the height adjustment knobs so that the diameter of the headband
becomes the minimum.
Plug of AC adapter
4 - 11
2. Open the lid of the carrying case and store the B.I.O. delivery unit.
1) Coil the illumination cable and the fiber optic cable and store them in the bottom of the part where
the B.I.O. delivery unit will be stored later.
2) Store the B.I.O. delivery unit over the cables stored in step 1).
3) Remove the wall pack from the stand. Then store the wall pack as illustrated below.
6) Put the aspheric B.I.O. lens in the case and store it in the place as illustrated below.
AC adapter
Stand
Wall pack
B.I.O. delivery
Carrying case * Store the coiled cables beforehand.
§5 OPERATING PROCEDURES
CAUTION
• Pay attention not to apply load to the connecting cable and fiber-optic cable when removing
the dust cover or the equivalent.
The photocoagulation system may malfunction.
2. Instruct all personnel present in the operation room except the operator and patient to wear
safety goggles (option) for the treatment beam.
CAUTION
• The safety goggles vary according to the laser type and its purpose. Be sure to use the
recommended goggles.
Recommended goggles ...... Model YL-300 for frequency doubled Nd: YAG: D315-532
L8 YL DIN (Produced by YAMAMOTO KOGAKU CO.,
LTD. Japan)
Master switch
Key switch
5-2
4. Perform the function checks.
Perform the check referring to [5.4 Function Checks] (p. 5-3) in the operator’s manual of the main
body.
* Record each result in [5.5 Function Check List] (p. 5-6) in the same operator’s manual.
5-3
AIMING switch
2. Put the B.I.O. delivery unit on the operator’s Height adjustment knob
head.
Circumference
1) Adjust the height of the headband with the adjustment knob
height adjustment knob.
Have the patient lie in a way suited for observation of and laser emission to the patient’s eyes while he/
she is on his/her back.
[Cautions regarding emission of the illumination light]
• Set the intensity of the illumination to the minimum level (not off) at the start of the observation.
Then gradually raise the level as necessary. Make a habit of resetting the intensity to the
minimum level every time an observation of a patient is finished.
Raising the intensity suddenly dazzles the patient at the start of the observation. In addition,
it may cause a thermal and photochemical damage to the retina of the patient (blue light
hazard).
• Never fail to pay attention to the following points when operating the B.I.O. delivery unit.
- Keep the intensity of the illumination as low as possible.
- Set the range of the illumination as small as possible.
- Use a color filter as necessary.
• Pay attention when emitting the illumination to the infant or patients with aphakic eye
or eye disease.
NOTE
• Be sure to set the intensity of the illumination
spot to the minimum (not off) level at the
beginning, and increase it gradually as Illumination control
necessary.
5-5
2) Select the size of illumination spot that is Illumination spot size selector
appropriate for observation and laser emission.
Move the aspheric B.I.O. lens, which is held approximately 5 cm away from the patient’s eye,
back and forth while the operator’s head remains still.
Perform observation under the condition where the fundus can be seen fully within the
aspheric lens. At this time, the fundus image is seen upside-down.
NOTE
• Use the aspheric B.I.O. lens facing the side with a white line on the rim toward the patient.
Patient
Wagon with
casters
Foot switch
5-6
AIMING switch
While fixing the positions of the aspheric B.I.O. lens and operator’s head, move the working distance*2
control knob to the right or left, and stop it at the position where the spot size of the aiming beam
becomes the minimum. Perform the same operation when the patient’s eye is an aphakic eye or has
been treated with fluid-air exchange.
[Examples of working distance (W.D.) and spot size (when 20D aspheric lens is used.)]
W.D.
300 mm 400 mm 500 mm 600 mm 700 mm
Condition of eye
Normal eye 185 μm 278 μm 371 μm 464 μm 556 μm
Aphakic eye
215 μm 324 μm 433 μm 541 μm 649 μm
(Anterior chamber: Water)
[Examples of W.D. and spot size (when 28D aspheric lens is used.)]
W.D. 300 mm 400 mm 500 mm 600 mm 700 mm
[Examples of W.D. and spot size (when 14D aspheric lens is used.)]
W.D. 300 mm 400 mm 500 mm 600 mm 700 mm
NOTE
• The actual spot size depends on positions of the B.I.O., aspheric B.I.O. lens, and patient’s
eye. The spot size is not indicated on the control panel. The spot size display on the control
panel shows “bio”.
Settings of all the photocoagulation conditions except the spot size setting are performed on the control
panel. All the photocoagulation conditions are shown on the control panel.
Aiming level indicator INTERVAL display
COUNTER display POWER display Emergency stop switch
READY mode.
CAUTION
• Always place the photocoagulation system in the STANDBY mode by pressing the STATUS
switch whenever the treatment laser beam is not going to be emitted.
This prevents an accidental emission of the laser beam even though the foot switch
is pressed inadvertently.
NOTE
• If pressing the footswitch produces a series of beeps but does not emit the treatment laser
beam, check whether the system is placed in the READY mode and the aiming beam is
emitted.
The system is designed to emit the treatment laser beam only when both of the conditions
described above are met.
• If pressing the footswitch does not produce any beep or does not emit the treatment laser
beam, check whether the footswitch is connected to the main body.
The treatment laser beam cannot be emitted if the footswitch is not connected to the main
body.
5 - 10
6. When the laser emission is completed, place the photocoagulation system in the STANDBY
mode.
STATUS switch
1) Press the STATUS switch to place the system “ ”
in the STANDBY mode.
The “ ” indication lights up on the
control panel.
Illumination control
After the postoperative treatment, release the patient from the bed.
9. When performing the laser emission on the next patient, go back to step 5 of “5.2 Preparation”
(p. 5-4) while the photocoagulation system is in the STANDBY mode.
5 - 11
Master switch
2. Instruct all personnel present in the operating room to take off the safety goggles.
The AIMING switch ▲ is pressed to emit Connect the cable plug of the fiber-
"F.S." the aiming beam even though the fiber- optic cable to the fiber connector of
optic cable is not connected. the main body.
NOTE
• To restart the photocoagulation system, turn
the key switch to the off ( ) position, and
turn it to the on ( ) position again.
§6 MAINTENANCE
If the power is on, turn off the key switch and master switch.
2. Pull out the burned-out illumination lamp from the B.I.O. delivery unit.
CAUTION
• The illumination lamp is very hot for some time after it has burned out, and touching it may
cause burn.
Remove the lamp after it has cooled enough.
Illumination lamp
Slit
Protrusion
Remove
Attach
Illumination lamp
Aligning the protrusion of the illumination lamp with the slit on the lamp housing. Then insert the lamp
as far as it goes. (Model of the lamp: AP II-7003 (2 pieces) manufactured by Keeler & Y.NA Ltd.)
CAUTION
• Never touch the lamp glass part with bare hands. If you touch the lamp glass accidentally,
wipe it gently with a clean cloth dampened with alcohol.
If the lamp glass part gets soiled with oil or dirt from fingers, the lifetime o it may be
reduced.
2) Turn the illumination control on the B.I.O. delivery unit, and verify that the illumination lamp lights
up.
6-2
6.2 Cleaning
Gently wipe the optical parts with a Keeler’s cleaning cloth or with a lint free wiper dampened with a
little rubbing alcohol. (Do not expose the system to the water at this time. However, the optical parts
can be wiped with a clean cloth dampened with water and wrung out.)
The parts to be cleaned are:
• Observation window • Eyepiece • Aspheric lens
CAUTION
• Never wipe the optical parts while they are dirty or wipe them strongly.
The optical parts may be scratched.
Clean the part that contacts the patient’s hair or forehead with a clean cloth dampened with rubbing
alcohol or neutral detergent.
2. Wipe the part that the operator’s finger touches with rubbing alcohol.
Clean the following parts that the operator’s finger touches with rubbing alcohol:
• Head band height /circumference adjustment knobs • Forehead bar adjustment knob
• Angle fixing knob • Filter selector • Illumination spot size selector
• Mirror adjustment knob • Illumination control • Pupillary distance adjustment knob
6-3
2. While touching the tip of the plug of the fiber optic cable to the gauze, clean the tip by
rotating the fiber optic cable lightly.
CAUTION
• Do not apply too much stress on or scratch
the tip while cleaning it.
The fiber optic cable inside the plug may
be broken.
3. Touch another part of the tip to the gauze and clean the probe a few times in the same
manner as in step 2 to make sure that the tip is properly cleaned.
4. Put the rubber cap on the plug of the fiber optic cable.
NOTE
• If lowering of the intensity or vignetting is found as a result of the check above, contact
NIDEK or your authorized distributor.
§7 SPECIFICATIONS AND CONFIGURATIONS
7.1 Specifications
1. Binocular indirect ophthalmoscope
1-1. Connectable photocoagulator: GYC-1000
1-2. Treatment laser beam power output:
50 to 1700 mW
<Tolerance>
50 to 90 mW: ± 20 %
100 to 1700 mW: ± 15 %
1-3. Aiming beam power output: Maximum; Red (635 nm) 0.1 to 0.3 mW
Minimum; one-eighth of the maximum
1-4. Working distance: 300 mm (SHORT) to 700 mm (LONG)
1-5. Spot size on the fundus: 185 µm (W.D. 300 mm)
278 µm (W.D. 400 mm)
556 µm (W.D. 700 mm)
* When using the 20 D aspheric B.I.O. lens on the fundus of a
normal eye
1-6. Beam divergence: 0.0372 rad (W.D.: 300 mm) to 0.0124 rad (W.D.: 700 mm)
<Tolerance>
± 20 %
1-7. Guard wavelength
of protective filter: 532 nm wavelength
1-8. Light source of illumination: 6 V, 1.7 A
1-9. Light source of halogen lamp: 0 to more than 3000 Lux
1-10. Dimension: 240 (W) × 280 to 330 (D) × 145 (H) mm
1-11. Weight: 520 g (without fiber-optic cable)
1-12. Fiber-optic cable: Length approximately 3 m
3. Environmental conditions
3-1. Transport / Storage: Temperature: 14 to 122 ºF (–10 to 50 ºC)
Humidity: 10 to 95 % (non-condensing)
3-2. In use: Temperature: 50 to 86 ºF (10 to 30 ºC)
Humidity: 80 % or less (non-condensing)
3-3. other conditions: little dust
NOTE
• The actual spot size depends on the working distance and positions of the aspheric B.I.O.
lens and patient’s eye.
7.3 Options
• Safety goggles for treatment beam (Model YL-300 for laser diode 2: DI 800-910 L4 produced
by YAMAMOTO KOGAKU CO., LTD.)
• Aspheric B.I.O. lens 28D (with a case)
Words in This Manual
To understand the contents of this manual easily, the following words are used.
Before reading this manual, confirm the meaning of the following words.
Aiming beam ............................. Red laser beam for aiming. The aiming beam is “OFF” when it is not
being emitted.
Exposure time .......................... Length of time that the treatment beam is emitted. (Unit: sec.)
Main body ................................ Main body of the green laser photocoagulation system GYC-1000.
Power output ............................. Power output of the green laser beam (at the aperture of the delivery
unit). (Unit: mW)
Spot size ................................... Diameter of the spot of the laser beam. (Unit: µm)