2D/3D Non-mydriatic Retinal Camera
Kowa
INSTRUCTION MANUAL
EU
KOWA nonmyd WX
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Introduction
Accept our congratulations on your purchase of KOWA nonmyd WX.
KOWA nonmyd WX is a Non-mydriatic retinal camera for mono and stereo retinal photography.
This manual provides a description of the operation procedures of KOWA nonmyd WX and important precautions to be
observed during its use.
Please read this manual carefully to assure that the instrument can demonstrate its full capabilities and work safely.
After you have finished reading, keep this manual in an easily accessible location near the instrument for future refer-
ence.
Operational considerations for safety
This manual describes important precautions to be observed when you use this system to assure that the system is used
safely without causing any damage to the human body or property of the purchaser and other persons.
The designations and pictorial symbols used in this manual have the following meanings.
These should be fully comprehended before reading the text of this manual.
Meanings of designations
If the instrument should be operated wrongly, there may incur a risk of causing
death or serious injury.
Warning
If the instrument should be operated wrongly, there may result in a bodily injury*1
or damage to property*2.
Caution
k
1 A bodily injury means an injury, burn, electrical shock and so forth that will not necessitate hospi-
talization or long-term outpatient treatment.
k
2 Damage to property means an extensive damage to a house and/or household goods as well as
a domestic animal and pet.
Meanings of symbols
Graphical indication of any danger (including warning and caution).
What is warned is explicitly and pictorially indicated by a picture or its associ-
ated message on or near a pictorial symbol.
Graphical indication of prohibited operation (prohibitive item).
What is prohibited is explicitly and pictorially indicated by a picture or its as-
sociated message on or near a pictorial symbol.
Graphical indication of any mandatory action (obligatory item).
What must always be done is explicitly and pictorially indicated by a picture
or its associated message on or near a pictorial symbol.
Disclaimer
Kowa is not responsible for:
• Any damage caused by fire, earthquake, third party’s action, any other accident or user’s intentional or unintentional
error, abuse or use under abnormal conditions.
• Any damage resulting from use of the product or its malfunction (e.g. operating loss, shutdown, change/loss of stored
data and so forth).
• Any damage resulting from disobedience of what is described in this manual.
• Any damage resulting from, for instance, malfunctioning of instrument caused by a combination of connected devices.
ꢀ
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Warning
If any abnormal smell, sound, overheating or smoke should be detected, be sure to turn OFF
the main power immediately and then unplug the instrument from the power outlet.
Continued use of the instrument may cause the instrument to malfunction or cause a fire. Con-
tact Kowa or your Kowa dealer for inspection immediately.
When replacing the flash lamp, make sure the instrument is turned OFF and then
unplugged from the power outlet. Otherwise, there may occur electrical shock.
When replacing the fuse, make sure the instrument is turned OFF and un-
plugged from the power outlet.
If the fuse holder cover is removed with the instrument unplugged, there may
Unplug
occur electrical shock.
Warning
High-Voltage
This instrument is equipped with a storage capacitor for photography light.
Replacing the flash lamp while this capacitor is still not yet fully discharged
causes a danger of an electrical shock. Check that the discharge indicator LED
is turned OFF before replacing the flash lamp.
Be sure to plug into the power outlet completely and securely.
Otherwise there may cause a fire or electrical shock.
Use a designated fuse only.
Otherwise, the instrument may malfunction or a fire may break out.
Obligatory
Make sure that the instrument is properly grounded to protect from bodily injury. Connect the
plug into the three-wire grounding type outlet with ground wire.
Otherwise, there may occur electrical shock.
Do not place a container or cup containing liquid near the instrument.
Spilled liquid entering into the instrument may cause electrical shock. If liquid should be spilled
into the instrument, turn OFF the main power and then unplugged from the power outlet. Con-
tact Kowa or your Kowa dealer for inspection.
Do not load the power outlet or cable with excess of its rated capacity.
ꢀf the main power cable should share a power outlet with other devices and the rated capacity
is exceeded, there may cause a fire or electrical shock.
Prohibitory
Do not insert any metal object into an air vent or opening of the instrument. ꢀt may cause an
instrument malfunctioning, fire or electrical shock.
Do not disassemble, modify or repair the instrument yourself.
It may cause a fire, electrical shock, instrument malfunctioning or bodily injury.
Refer all servicing to Kowa or your Kowa dealer.
The product assembled by yourself will not be covered under warranty nor any other service.
Disassembly prohibited
Caution
The power supply must be provided for the sole use of this instrument.
Sharing a same power supply with other devices may cause malfunctioning.
When operating the instrument, take good care so that the patient’s eye, nose or face does not
come in contact with the instrument.
When moving up or down the chin rest to adjust the height of the patient’s eyes, carefully ma-
nipulate the instrument while checking the position of the patients’ head.
A patient with the smaller head may get his or her head caught between the components.
Obligatory
Handle the flash lamps and fuses made of glass with good care.
ꢀꢀ
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Caution
Do not pull the power supply cable when unplugging.
Doing so may damage the cable and cause a fire or electrical shock. Be sure to hold the plug
when unplugging.
Do not plug or unplug the power supply cable with wet hand.
Otherwise, there may occur electrical shock.
Do not install the instrument at unstable location such as on a shaky base or a tilting surface.
Doing so may cause the instrument to drop or fall over and result in a bodily injury.
Do not replace the flash lamp immediately after turning the OFF the main power.
You could be burned by the lamp heated to a high temperature.
Wait for more than 10 minutes to cool the lamp down before replacing.
Caution
High-temperature
Do not touch the flash lamp bulb with your bare hand.
Otherwise, the lamp may reduce the light intensity and longevity.
Do not increase the observation illumination light intensity more than required.
Otherwise the eye may be injured.
Prohibitory
Do not increase the photography light intensity more than required.
Otherwise the patient may experience pain and his or her eye may be injured.
The air vent must not be obstructed.
Obstructing the air vent may increase the internal temperature resulting in malfunctioning of
the instrument or a fire.
Do not insert any metal object into an air vent or opening of the instrument.
ꢀt may cause electrical shock and malfunctioning of the instrument.
When operating this instrument, keep your fingers off the gap between the optical head base
and the power supply or the chin rest support and the forehead rest support, or the gap under-
neath the chin rest.
Otherwise, the fingers may be pinched and injured.
Instruct the patient not to place his or her fingers on the instrument.
Do not wipe the outer surface of the instrument with solvents such as benzene, alcohol, or-
ganic solvent, ether.
Doing so may cause discoloration or degradation.
Keep your finger off the spaces shown with an arrow. Otherwise you may be injured.
A: Keep your finger off the locations shown with an arrow “A”
when operating the instrument.
Otherwise, the fingers may be pinched and injured.
Caution
Instruct the patient not to place his or her fingers on the
instrument.
B: Take good care so that the patient’s eye, nose or face
does not come in contact with the locations shown with
an arrow “B” when operating the instrument.
A
A
Caution
Caution
C: When moving up or down the chin rest to adjust the
height of the patient’s eyes, carefully manipulate the
instrument while checking the position of the patients’
head.
A
A
A patient with the smaller head may get his or her head
caught between the components.
B
C
D
D: The air vent must not be obstructed.
Obstructing the air vent may increase the internal
temperature resulting in malfunction of the instrument or
a fire.
A
A
Caution
Caution
A
D: Do not insert any metal object into an air vent or
opening of the instrument.
A
A
ꢀt may cause electrical shock and malfunctioning of the
instrument.
D
ꢀꢀꢀ
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Meanings of symbols
Symbol for “Type B applied part”.
Symbol for “Power ON”.
Symbol for “Caution”.
Symbol for “Warning High-voltage”.
Symbol for “Warning High-temperature”.
Symbol for “MANUFACTURER”
Symbol for “Power OFF”.
Symbol for “AUTHORISED
REPRESENTATꢀVE ꢀN THE
EUROPEAN COMMUNITY”
ꢀV
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Operating precautions
1. Operating environment
1) Instrument should be operated only by qualified and trained personnel.
2) Handle the instrument with care, and do not apply strong shock to the instrument.
3) Avoid high temperature and humidity, direct sunlight, and dust when installing and storing the instrument. Strictly
observe the following environmental conditions.
Operating
10 to 35 °C
30 to 90 %
Transporting and storing
-15 to +55 °C
Environmental temperature
Relative humidity
10 to 95 %
4) Avoid condensation when using, transporting or storing the instrument.
5) Use the designated digital camera only since other camera may adversely affect the safety or performance of this
instrument.
6) ꢀnstall the instrument in a room where the lighting is 5 lux or less which you may barely manage to read a
newspaper.
2. Precautions on electric system
1) When the instrument has not been used for a long period of time, inspect the items below.
ꢀnspect if the objective lens is free from soils.
ꢀnspect if intensity of the lamps appropriately adjustable.
2) ꢀnstall the system in a location where there is little risk of the plug being pulled out while operating. ꢀf the plug should
be pulled out accidentally, be sure to turn OFF the main power before plugging the system back in.
3) Kowa is not liable for malfunctions and/or damages resulting from maintenance and/or repairs performed by the
third party other than an agent authorized by Kowa.
4) Kowa is not liable for malfunctions and/or damages resulting from maintenance and/or repairs using parts other than
repair parts specified by Kowa.
5) The input voltage should always be maintained within ± 10% of the rated voltage.
6) Do not turn ON the flash lamp and adjust photography light intensity at the same time.
7) Wait for approx. 10 seconds to stabilize the power unit after turning the power ON before using the switches on the
operation panel.
8) Do not turn the main power ON and OFF in succession. Allow an interval of at least 10 seconds before turning the
main power ON and OFF.
9) Be sure to turn OFF the main power before connecting an external device.
10) Do not touch the patient and connectors at the same time as it may adversely affect the safety.
11) Disinfect using alcohol the parts accessible by the patient.
12) The power supply must be provided for the sole use of this instrument.
3. Precautions when using a digital camera with this instrument
1) Carefully handle the objective lens as soiled or scratched part of the objective lens may be imaged as white spots.
2) Always cover this instrument and the digital camera when not in use in order to protect them.
3) Do not apply strong shock or force to the objective lens.
4) Set a dial or knob with clicking positions to its designated position. The dislocated diopter compensation knob may
result in a photograph with a missing part or underexposure.
5) Securely install the digital camera. The digital camera installed insecurely may cause distortion of an image or
misalignment of focus.
The digital camera installed insecurely may fall off and become unusable.
6) Never disassemble or adjust this instrument or the digital camera by yourself as it uses precision parts which
requires special tool for doing so.
4. Disposal precautions
1) LCD monitor of this instrument has a fluorescent lamp that contains mercury. When disposing this instrument,
applicable federal, state, and local regulations must be observed.
2) When disposing, this instrument and/or its consumables is categorized as industrial waste; therefore, the disposal
must be handled by licensed industrial waste disposal contractor.
V
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Precautions: use of medical electrical system
1. Precautions on use of medical electrical system
1) All components of this medical electrical system may be installed within a limited patient environment (a radius of 1.5
m around a patient) when all components are installed in accordance with the installation instructions using “Multi-tap
with Isolation Transformer”, which is one of the system components.
2) As prerequisite for installing to this system, other components (a PC, printer, video capture printer, video monitor,
or other devices) which do not comply with ꢀEC60601-1 must be powered from Multi-tap with ꢀsolation Transformer.
The electric power to these components supplied from an electric source other than Multi-tap with ꢀsolation
Transformer (e.g., wall outlets) may cause increased enclosure leakage current or potential difference between
protective grounds resulting in the injury to the patient or operator. Use Multi-tap with ꢀsolation Transformer only for
supplying the power to the components other than the system components.
3) Any medical electrical equipment that connected to this system to compose a medical system must comply with
ꢀEC60601-1.
4) Any non-medical electrical equipment that is connected to this system to compose a medical system must comply
with safety standards of IEC or ISO provisions applicable to such a non-medical electrical equipment.
5) Do not use any additional multi-tap or extension power cable other than those Kowa specified to this system.
6) Power supply to this system or “Multi-tap with Isolation Transformer” must be provided individually. (Do not route
the power supply through other multi-tap to the system or “Multi-tap with Isolation Transformer”.)
7) The power cable for an electrical equipment that compose a medical system must have durability that meets
ꢀEC60245/ꢀEC60227 or higher standards.
8) Assure that the power supply is turned OFF when connecting other device to the system.
9) Do not turn ON the power supply until all devices are completely connected.
10) Do not place or install the devices and the system components on the unstable or inclined table.
2. Precautions for use of “Multi-tap with Isolation Transformer”
1) Do not place “Multi-tap with Isolation Transformer” directly on the floor. Water droplets during room cleaning may
enter the multi-tap resulting in the component failure.
2) The power supply cable to “Multi-tap with Isolation Transformer” must be connected to a power receptacle with a
protective ground terminal equipotential to the protective ground of this instrument.
3) When using a multi-tap power receptacle with a protective ground terminal, read the instruction for use attached to
the receptacle to familiarize yourself with the correct use before use.
3. Daily maintenance and cleaning
1) System components
• Wipe the soiled outer surface with firmly squeezed dampened soft cloth. Use mild detergent to remove excessive
soils. Do not use chemicals or solvents such as thinner and benzene. (As the LCD monitor screen cover easily gets
scratched, lightly wipe it with soft cloth such as gauze.)
• Refer to the instruction for use provided with each device for details of device maintenance and cleaning.
2) Power cables, connecting cables, and connectors
• Visually inspect that all cables have no flaw or damage.
• Visually verify that earth leads of all components and protective ground terminals are securely connected.
• Disconnect the power cables from the power supply receptacles when you do not use the system for a long period
of time.
3) Others
• When you add a PC to the system for a filing purpose, captured images are stored in the HDD of the PC. Back up
the data stored in the HDD regularly since HDDs may have a mechanical or electrical failure.
Vꢀ
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●
Combination of medical electrical equipment and non-medical electrical equipment
IEC 60601-1-1 “Safety requirements for medical electrical systems” describes the components combination grouped into
various clinical settings. The brief overview of ꢀEC 60601-1-1 is shown below.
Medically used room
Feasible solution
(See clause 19 in all
situations)
Non-medically
used room
ꢀnside
Outside
the PATꢀENT
ENVꢀRONMENT
Situation No.
the PATꢀENT
ENVꢀRONMENT
1a ꢀtems A and B in
PATꢀENT ENVꢀRON-
MENT
A
ꢀEC
60601
B
ꢀEC
60601
1b ꢀtems A and B in
PATꢀENT ENVꢀRON-
MENT
For B:Additional
protective earth or
separating transformer
A
ꢀEC
60601
B
ꢀEC
XXXXX
1
A
ꢀEC 60601
1c ꢀtem A powerd from
specified power supply
in item B in PATꢀENT
ENVꢀRONMENT
For B:Additional
protective earth or
separating transformer
B
ꢀEC XXXXX
2a ꢀtem A in PATꢀENT
ENVꢀRONMENT and
item B in medically
used room
A
ꢀEC
60601
B
ꢀEC
60601
2
2b ꢀtem A in PATꢀENT
ENVꢀRONMENT and
item B in medically
used room
A
ꢀEC
60601
B
ꢀEC
XXXXX
For B:See 19.201
and its rationale
3a ꢀtem A in PATꢀENT
ENVꢀRONMENT and
item B in non-medically
used room
A
ꢀEC
60601
B
For B:See 19.201
and its rationale
ꢀEC 60601
or ꢀEC XXXXX
Common protective earth
3
A
ꢀEC
60601
B
3b ꢀtem A in PATꢀENT
ENVꢀRONMENT and
item B in non-medically
used room
ꢀEC 60601
or ꢀEC XXXXX
For B:Additional
protective earth or
SEPARATꢀON DEVꢀCE
Protective earth with po-
tential difference
Protective earth
KEY TO TABLE
• Additional protective earth: If necessary, provide additional protective earthing , which is permanently connected(See also
58.201).
NOTE Equipment modification may be required.
• Separating transformer : If necessary, limit the ENCLOSURE LEAKAGE CURRENT, by using an additional separating
transformer according to annex EEE.
NOTE1 No equipment modification is required.
NOTE2 A separating transformer is a transformer with one or more input winding(s) separated from the output winding(s) by at
least basic insulation [ꢀEC 60989]
• SEPARATION DEVICE : If necessary, apply SEPARATION DEVICE.
• ꢀEC 60601
: MEDꢀCAL ELECTRꢀCAL EQUꢀPMENT in compliance with ꢀEC 60601.
• IEC XXXXX
: Non medical equipment in compliance with relevant IEC safety standards.
Vꢀꢀ
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Operational considerations for hospital grade electrical
instrument (safety and accident prevention)
1. Only qualified personnel should operate this instrument.
2. The following items shall be considered when installing the instrument.
1) ꢀnstall at a location away from water or accidental splashing.
2) Install at a location which will not be adversely affected by atmospheric pressure, temperature, humidity, ventilation,
sunlight, dust, air containing salt, sulfur and other substances, and the like.
3) Take care to guard against tilt, vibration and strong impacts, for instance, during transportation.
4) ꢀnstrument must not be installed at locations where chemicals are stored or gasses are generated.
5) Be careful with the radio frequencies, voltages and allowable amperes (power consumption) of the power supply.
6) Properly connect ground wires.
3. The following items shall be considered before using the instrument.
1) Make sure that instrument activates properly after checking switch contact, polarity, dial setting and meters and so
forth.
2) Make sure that the instrument is properly grounded.
3) Make sure that all cords are properly connected and secured.
4) Use of other instruments and appliances on the same power circuit is liable to cause errors and incorrect flash
output resulting in incorrect diagnosis or hazards.
5) External circuits and connectors that may come in direct contact with the patient must be checked frequently for
signs of wear.
4. The following items shall be considered when using the instrument.
1) Be sure to minimize the time and quantity required for diagnosis and treatment.
2) Always assure that the instrument and patient are in good condition.
3) When an abnormality is found on the instrument, take proper measures, for instance, to stop the operation of the
instrument while assuring the patient’s safety.
4) Do not allow the patient to touch any of the instrument controls.
5. The following items shall be considered after using the instrument.
1) Turn OFF the instrument after setting control switches, dials and so forth to their initial status following with a
specified procedure.
2) Do not pull cords for removal because an excessive force is exerted on them.
3) The following shall be considered regarding storage location.
• Store the instrument at locations free from splashes of water.
• Store at a location which will not be adversely affected by atmospheric pressure, temperature, humidity,
ventilation, sunlight, dust, air containing salt, sulfur and other substances, and the like.
• Take care to guard against tilt, vibration and strong impacts, for instance, during transportation.
• ꢀnstrument must not be stored at locations where chemicals are stored or gasses are generated.
4) Clean and rearrange accessories, cords, and the like.
5) The instrument must be cleaned prior to use so that there will be no problem when using it again.
6. In case of a problem or malfunction, stop the operation and contact Kowa or your Kowa dealer for repair.
7. Instrument shall not be modified.
8. Maintenance
1) Periodically check the instrument and its components for any abnormality.
2) When using the instrument that has not been used for a while, it must be checked beforehand to assure that it is in
normal condition and operates safely.
9. Be careful of the possibility that incorrect operation may be caused by strong electromagnetic waves.
This instrument is examined based on EN 60601-1-2:2001.
The purpose of this standard is to keep safety against the dangerous obstacle in typical medical facilities.
When this instrument is influenced by other instrument, or when it affects other instrument or when there is such fear,
please devise to move this instrument and other apparatus or to make the distance between those instrument.
Moreover, if there is an unknown point, please consult our company, or an agency beforehand.
Vꢀꢀꢀ
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Accessories
Main body:1
digital camera:1
Power supply cable:1(2.5m)
USB cable(Type A-B):1(3m)
Chin rest paper
retaining pin:2
USB cable(Type A-Mini-B):1(3m)
Chin rest paper:1
Blower:1
Fuses:2
Dust cover:1
Instruction manual:1
Filing software:1
User’s guide:1
Installation manual:1
Optional accessories
External fixation target:1
Numerical keypad:1
PC (filing software) :1
K9L-LE57
OS: Windows XP/VꢀSTA
CPU : Celeron 1.0GHz
Memory : 512Mbyte
Num
/
8
Lock
BS
7
9
6
3
4
5
Display : XGA
Enter
1
2
0
00
* Comparable or higher performance required
ꢀX
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Contents
Introduction.................................................. I
Meanings of symbols................................IV
Operating precautions...............................V
6
7
Operational procedure in photography.. ꢀ6
6.1 Normal, SP, and stereo modes .................. 16
6.2 Precautions for continuous photography.... 22
6.3 Terminating photography............................ 22
Advanced photography ........................... 23
Precautions: use of medical electrical
system ........................................................VI
7.1 Mosaic mode photography......................... 23
7.2 External fixation target ............................... 27
7.3 Diopter compensation range...................... 27
Operational considerations for hospital grade electrical
instrument (safety and accident prevention).......VIII
Accessories ...............................................IX
8
9
Troubleshooting ....................................... 28
Optional accessories...................................ꢀX
Menu operation......................................... 3ꢀ
Contents...................................................... ꢀ
9.1 Starting menu............................................. 31
9.2 Objective lens cleaning lamp ..................... 31
ꢀ
System description .................................... 2
1.1 ꢀntended use ................................................ 2
1.2 System overview.......................................... 2
1.3 Features....................................................... 2
1.4 Name and function of each component ....... 3
Installation................................................... 9
9.3 Mosaic internal fixation target setting
(Switching internal fixation target in
mosaic mode photography )...................... 31
9.4 Other setting menu..................................... 33
ꢀ0 Maintenance and inspection ................... 36
2
10.1 Daily maintenance...................................... 36
10.2 Daily inspection (by users)......................... 36
10.3 Regular ꢀnspection (by manufacturer)........ 37
10.4 Cleaning the objective lens........................ 37
10.5 Disinfection................................................. 38
10.6 Outer cleaning............................................ 38
10.7 Replacing flash lamp.................................. 38
10.8 Fuse replacement ...................................... 40
10.9 Refilling and replacing consumables.......... 40
11 Specifications ........................................... 4ꢀ
2.1 ꢀnstalling the system..................................... 9
2.2 ꢀnstalling external device (optional PC)...... 11
2.3 Connecting PC........................................... 11
Saving captured images.......................... ꢀ2
3
4
3.1 Saving captured images in PC
(optional device)......................................... 12
3.2 Saving captured images in a SD card........ 12
Basic operation......................................... ꢀ3
4.1 Moving component fixing screw................. 13
4.2 Coarse motion: moving the optical head base
for a long distance ...................................... 13
12 Technical information .............................. 42
4.3 Fine motion: moving the optical head base
for a short distance..................................... 13
12.1 Description of digital camera...................... 42
12.2 Digital camera settings............................... 43
12.3 ꢀmaging conditions output.......................... 44
4.4 Raising and lowering the optical component 13
4.5 Raising and lowering the chin rest............. 13
Preparations for photography................. ꢀ4
ꢀ3 Electromagnetic compatibility
(IEC60601-1-2)........................................... 45
5
5.1 Preparing the instrument............................ 14
5.2 Preparations for patient’s eye examination 15
5.3 Selecting a photography mode .................. 15
ꢀ
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1 System description
1.1 Intended use
KOWA nonmyd WX is intended for use with retinal image capturing without mydriatic.
The retinal image can be stored to an image filing drive through serial interface.
1.2 System overview
This system is an instrument that enables retinal examination and retinal image capturing using infrared rays without re-
quiring the patients to take any mydriatics and uses the normal or stereo light path to capture, record and display images.
Also the designated filing software installed in a PC allows you to save, register or print the captured images.
1.3 Features
1) One-touch switching Normal, SP and stereo modes.
2) Field angles available are 45° with a round mask for normal mode and 34° (20° horizontal and 27° vertical directions)
with a square mask for stereo mode.
3) Functions that support mosaic mode photography.
4) A high resolution digital camera is installed.
5) An intuitive operation panel allows you to diagnose effortlessly.
6) Anterior segment button enables one-touch switching between anterior segment alignment and retinal alignment
screens easily.
Modes and captured images
Photography
mode
Normal mode
SP (small pupil) mode
Stereo mode
Captured
image
45°
45° k
34°(20°× 27°)
Field angle
Some eyes may cause a fiare around their circumference.
k
2
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1
System description
1.4 Name and function of each component
Diopter compensation knob
LCD monitor
ꢀf cannot in-focus by turning
the focusing knob, pull the
diopter compensation knob
to make (-) or (+) compensa-
tion until the focus point is
found.
Black-and-white live image
of the anterior segment and
retinal appears for you to
use for alignment and fo-
cusing.
Lamp cover
Remove this cover to replace
a flash lamp.
Digital camera
Stores and displays cap-
tured images.
Mosaic button
Use this button to select ei-
ther mosaic ON or OFF.
Shutter button
Pressing this button turns
the flash on and takes a
photo.
Menu buttons
Hold down the center button
more than 2 seconds to access
the menu mode for various set-
tings of the instrument. You can
also switch the internal fixation
target position for the auto set-
ting of internal fixation target
position during mosaic mode
photography.
Control lever
Instrument label
Use this lever to move
around the optical head
base. Turning the control
lever moves the optical
head base vertically.
Operation panel
(See the next page for de-
tails)
Blue / Brown
selection switch
Use this switch for setting
the intensity suitable for blue
or brown eye.
3
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1.4 Name and function of each component
Operation panel
Retinal observation light
intensity control knob
Internal fixation target selection button
Switch the internal fixation target position to posterior, optic disc, and center of mac-
ula by pressing this button to go through these selections in normal mode. (ꢀn stereo
mode, pressing this button goes through optic disc, center of macula and then poste-
rior.) The button turns OFF for posterior, illuminates for optic disc, and flushes for cen-
ters of macula. This button turns OFF during mosaic mode photography and the inter-
nal fixation target selection function becomes disabled.
Used for adjusting light intensity
during retinal observation.
Exposure compensation Anterior segment button
Moving component fixing screw
Tighten the screw when you need to
fix the moving component.
knob
Used for adjusting the photog-
Pressing this button switches the
image shown on the LCD monitor
between anterior segment and reti-
nal. The button illuminates when
the anterior segment is selected.
raphy light intensity when pho-
tographing.
Exposure compensation indicator
ꢀlluminates when exposure compensation knob is
in any position other than “0” and turns OFF in “0”.
Stereo mode button
Used for a stereo image with
the field angle of 34° (20° hor-
izontal and 27° vertical direc-
tions).
Chin rest raising and lowering buttons
Used for raising or lowering the chin rest. The button illu-
minates normally and flashes when it is in “SLEEP MODE”.
SP mode button
Used for an image with the
field angle of 45° for a small
pupil diameter.
Normal mode button
Used for an image with the
field angle of 45° for a normal
pupil diameter.
4
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1
System Description
Anterior segment
observation lamp
ꢀnfrared LED lamp that illu-
minates when the anterior
segment is observed.
Forehead rest
Used for resting the patient’s
forehead against it.
Eye level mark
Focusing knobs
Knobs located on both sides of the
Used for aligning the verti-
cal position of the patient’s
eye with this mark.
, used for focusing.
optical head base
Lamp cover screw
Loosen this screws to re-
move the lamp cover.
Objective lens
Chin rest
Used for sustaining the pa-
tient’s chin position.
Air vent
Power supply unit
(See the next page for details)
5
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1.4 Name and function of each component
Power supply unit
Power switch
q
Fuse holder
Electrical supply inlet
Cable clamps
Used for holding cables to keep
them from being disconnected.
| :ON
:OFF
External fixation target
connecting terminal
Air vent
A terminal which you connect
an external fixation target (op-
tional accessory: K9L-LE57).
Image output terminal
Used for connecting a PC to the instrument using a USB cable supplied.
Imaging condition output terminal
When you wish to acquire both captured images and imaging condition, use the USB
cable supplied with this instrument to connect a PC to the instrument.
Numerical keypad connecting terminal
Connect a numerical keypad (optional accessory) using this terminal when you define
an internal fixation target position of your choice for mosaic mode photography.
Overall system schematic
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1
System description
Monitor screen indications
Anterior segment observation display
Anterior
Field angle
This indicates the field angle currently selected.
1
2
3
0
“ANTERIOR” indicates that the instrument is currently
showing the anterior segment observation display.
anterior segment observation : ANTERꢀOR
Normal or SP mode
Stereo mode
: 45˚
: 20˚ x 27˚
retinal observation
: none
Left or right eye
This indicates which eye you are currently observing.
A
B
Photography mode
This indicates the current photography mode.
Normal mode : NORMAL
Left eye : L
Right eye : R
SP mode
Stereo mode
: SMALL PUPꢀL
: STEREO
Diopter compensation
This indicates the diopter compensation knob position.
Mosaic mode photography
No corrective lens used (−12 m-1(D) to +13 m-1(D)): none
ON
OFF
: MOSAꢀC
: none
+
compensation
compensation
(+10 m-1(D) to +35 m-1(D)): D+
(−32 m-1(D) to −10 m-1(D)): D−
−
Pupil diameter aid for normal or stereo mode
This aid appears when normal or stereo mode is selected.
4
5
6
Mosaic mode photography sequence or posi-
tions
C
D
Pupil diameter aid for SP mode aids
these aids appear when SP mode is selected.
This indicates the current photographing sequence num-
bers or photographing positions in mosaic mode photog-
raphy.
Anterior segment working dot position aids
These aids appear during anterior segment observation
for you to adjust the working dots.
AUTO
MANUAL
: No. : 1a to 9a
: POSꢀTꢀON : 1 to 9
Mosaic fixation target switches
They appear when the internal fixation target is set to auto
during mosaic mode photography.
Working dots
The dots are shown optically for you to adjust the distance
and position of a patient’s eye.
7
8
uNEXT
:
Pressing the right button of the menu but-
tons switches the current photographing
position to the next position.
Blue eye
This indicates the current Blue / Brown selection switch
status.
tBACK
:
Pressing the left button of the menu but-
tons switches the current photographing
position to the previous position.
BLUE : Blue
BROWN : none
Exposure compensation
This indicates the current exposure compensation knob
position.
9
+ 2/ + 1/0/ − 1/ − 2
ꢁ
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1.4 Name and function of each component
Retinal observation display
Fixation target position
This indicates the fixation target position currently turned on.
Normal, SP, and stereo modes
Retinal working dot position aids
E
H
I
These aids appear during retinal observation for you to
adjust the working dots.
No aid appears in mosaic mode photography.
Posterior
: CENTRAL
: DꢀSC
Optic disc
Working dots
Center of macula
External fixation target
Mosaic mode photography
Internal fixation target
: MACULA
: EXT
These dots are shown optically for you to adjust the dis-
tance and position of a patient’s eye. No dot appears in
mosaic mode photography.
: AUTO/MANUAL
Normal mode photographing range
This indicates the photographing range in normal mode.
J
K
(this indicates the currently selected
position selecting method)
External fixation target
: EXT
SP mode photographable range
This aid appears when SP mode is selected. ꢀt indicates
an approximate range where a clear image is captured.
Completed mosaic mode photography
F
G
This indicates the completed photographing sequence
numbers or photographing positions in mosaic mode
photography.
Stereo mode photographing range
This aid appears when stereo mode is selected and indi-
cates the photographing range in stereo mode.
L
M
AUTO
:1a to 9a
MANUAL :1 to 9
Eye fixation direction and mosaic mode pho-
tography position
Focus dots
These dots are shown optically for you to use as refer-
ence when focusing.
The dots appear when no diopter compensation is selected.
No dot appears when a + compensation or – compensa-
tion is selected.
This indicates the guiding or alignment direction when the
internal fixation target is used in mosaic mode photography.
“ FIX TARGET ” indicates the direction to which you guide
the patient’s eye fixation.
8
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2 Installation
2.1 Installing the system
1 Place the instrument on a powered optical table (optional accessory).
observe the following precautions when moving the instrument.
• Fasten the moving component fixing screw.
• Put your hands under the power supply unit and lift the instrument as
shown in the right figure.
• Do not lift the instrument with holding any parts other than the above.
• Check the place where you are going to set the instrument is flat with no
obstacle that may catch your hand.
警
告
注
意
ランプ、フラッシュランプ、
光灯を交換する時は必ず
スイッチを OFF にし
て行ってください。
K9L33 496B
ラ
ン
プ
、
フ
ラ
ッ
シ
ュ
ラ
ン
プ
、
蛍
蛍
光灯の使用
直
後は熱くなって
感電
注意
電源
高温
注意
いますので充分冷ましてから
交換してください。
K9L33 496C
• Be careful not to pinch your hand during installation.
2 Make sure that the power switch is in OFF (“q”) position.
3 ꢀnstall the digital camera in the camera mount.
4 Connect the synchronous, power supply, trigger and USB cables to the
digital camera.
Power supply cable
Synchronous cable
Trigger cable
USB cable
All cables connected
k
k Connect the cable with “ ” mark facing to-
wards the LCD monitor of the digital camera.
5 Ensure that an eye piece cap is attached to the viewfinder of the digital
camera.
9
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2.1 ꢀnstalling the system
6 Make sure that the power switch is in OFF position.
Connect the power supply cable to the power supply cable connector.
Connect the power supply cable plug to a power outlet.
OFF
7
Place the chin rest paper on the chin rest and fix the paper with the chin rest
paper retaining pin. Use a sheet of chin rest paper per patient. Remove the
top sheet of chin rest paper for the next patient.
Do not connect a digital camera other than that supplied with this instrument.
x
x
The digital camera is detachable: however, keep detaching/attaching the digital camera to the minimum in order
to prevent debris or dust from entering into the instrument and the digital camera.
The digital camera needs to be disconnected from the instrument when the instrument is to be relocated or the in-
side of the digital camera is to be cleaned. In such a case arises, contact Kowa or your Kowa dealer in advance
for the correct procedures and precautions for detaching the digital camera.
x
The digital camera supplied with this instrument is set for the retinal camera photography. Do not change the
setting.
x
Do not detach the eye-piece cap from the digital camera.
Do not disconnect the cables connected to the digital camera.
x
x
Make sure that the instrument is properly grounded to prevent
bodily injuries. Be sure to connect the plug into the three-wire
grounding type outlet with ground wire.
Warning
Obligatory
Otherwise, there may occur electrical shock.
The power supply must be provided for the sole use of the reti-
nal camera.
Sharing the same power supply with other devices may cause
Caution
Obligatory
malfunctioning.
ꢀ0
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2
ꢀnstallation
2.2 Installing external device (optional PC)
Install a PC by following the PC’s instruction manual and turn it on.
Install the application software supplied with the PC. For details of installation, refer to “Installation manual (filing soft-
ware)”.
When you use a peripheral device and/or other device connected to the peripheral device, it must meet all applicable
EN(ꢀEC) standards.
Data processing device must meet EN60601-1(ꢀEC60601-1) or ꢀEC60950. The system that combines such data
processing device must meet EN60601-1-1(ꢀEC60601-1-1). The system administrator who builds such system bears
all responsibility to have the system comply with requirement of EN60601-1-1(IEC60601-1-1). Should you have any
question, contact Kowa sales representative or dealership.
2.3 Connecting PC
Connect the image output terminal (PC:ꢀmage) of this instrument to an USB terminal of the PC using the USB cable (Type
A-B) provided with the instrument.
Connect the imaging condition output terminal (PC: Data) of this instrument to the USB port of the PC using the USB
cable (Type A-Mini- B).
k
For information on how to connect the instrument to the PC as well as the details of how to use the software, see the
attached “Installation manual (filing software)” and “User’s guide (filing software)”.
ꢀꢀ
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3 Saving captured images
Save captured images using the methods described in 3.1 or 3.2 below.
3.1 Saving captured images in PC (optional device)
Install the supplied filing software into the PC (optional device).
Use a USB cable supplied to connect a PC to the instrument. Captured images will be stored in the PC after it is con-
nected to the instrument.
About the PC
For details of the specification of the required PC, see the attached “Installation manual (filing software)” and
“User’s guide (filing software)”.
Do not use any USB cable other than the supplied cable.
Using other USB cable may inhibit normal operation.
x
x
k
For information on how to connect the PC to the instrument as well as details of how to use the software, see the
attached “Installation manual (filing software)” and “User’s guide (filing software)”.
3.2 Saving captured images in a SD card
ꢀnsert a SD card into the digital camera.
Captured images will be stored in the SD card.
Captured images saved in a SD card
Captured images saved in a SD card may be displayed on the LCD monitor of the digital camera. The images may
be printed out connecting the digital camera to a printer. Contact Kowa or your Kowa dealer for details.
The photographed images are not saved in the SD card when the instrument is connected with the PC.
x
ꢀ2
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4 Basic operation
4.1 Moving component fixing screw
Completely loosen the moving component fixing screw before starting any
photography using this instrument.
Completely tighten the moving component fixing screw before moving this
instrument to other installation site.
tighten
loosen
4.2 Coarse motion: moving the optical head base for a long distance
In order to move the optical head base for a slight distance, move the control
lever lengthwise or crosswise while holding the lever tightly in upright position.
4.3 Fine motion: moving the optical head base for a short distance
In order to move the optical head base for a very short distance, hold the
control lever gently and tilt it lengthwise or crosswise.
4.4 Raising and lowering the optical component
In order to move the optical component up and down, turn the rubber ring of
the control lever.
Turning the ring right moves the optical component up and turning left moves
the optical component down.
4.5 Raising and lowering the chin rest
In order to move the chin rest up, press chin rest raising button.
In order to move the chin rest down, press chin rest lowering button.
ꢀ3
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5 Preparations for photography
5.1 Preparing the instrument
1 Make sure that the moving component fixing screw is completely loosened.
2 Make sure that the instrument is correctly connected to the PC.
Make sure that the PC is turned ON and the application software is started.
3 Remove objective lens cap.
4 Turn ON the power switch (place it in “ | ” position).
5 Make sure that retinal observation light intensity control knob, exposure compensation knob and diopter compensation
knob are in their initial position.
The initial positions for the knobs are as below
Retinal observation light intensity control knob : Approx. 10-o’clock position
Exposure compensation knob
: 0 (The indicator under the knob turns OFF at the reference position.
When it is at a position other than the reference position, the indica-
tor illuminates.)
Diopter compensation knob
: Pressed position. (“D+” or “D-” does not appear on LCD monitor
when it is in the initial position.)
Retinal observation light intensity control knob
Exposure compensation knob
Diopter compensation knob
Exposure compensation indicator
ꢀ4
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5
Preparations for photography
5.2 Preparations for patient’s eye examination
1 Reduce room’s illumination as bright as to make letters on this manual barely readable so that patient’s pupil can
naturally turn to the size of pupil diameter aid or greater.
2 ꢀnstruct the patient to take off his or her glasses or contact lenses.
3 Remove the top sheet of chin rest paper.
4 Move and keep optical component as close as possible to you and ask the
Eye level mark
patient to rest the chin on chin rest.
5 Adjust chin rest height until the patient’s eye level comes to the position of
eye level mark.
6 ꢀnstruct the patient to rest his or her forehead on forehead rest.
7 Adjust height of the table which this instrument is installed on so that the
patient can place his or her chin on chin rest with ease.
8 Adjust optical component height until it comes to the position of eye level
mark.
5.3 Selecting a photography mode
This instrument has “Normal mode”, “SP mode”, and “Stereo mode” for
photographing.
Press “Normal” button for normal photography, “SP” button for small pupil
photography, or “Stereo” button for stereo mode.
Upon activation of the instrument, “Normal mode” is selected.
The photography mode currently selected is indicated on the upper left
corner of LCD monitor.
This instrument also has mosaic mode photography for imaging the center
of macula and 8 points surrounding the macula. Press “Mosaic” button for
mosaic mode photography.
ꢀ5
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6 Operational procedure in photography
6.1 Normal, SP, and stereo modes
The chart shown blow describes the operation procedure in normal, SP, and stereo modes. Details of items shown in the
chart are described on the following pages.
Preparing this instrument
Preparations for patient’s eye examination
]
]
Preparations for
photography
Turn ON the power
switch
1) Selecting a photography mode
Normal mode
SP mode
: NORMAL
Selecting a photog-
raphy mode
: SMALL PUPꢀL
: STEREO
Stereo mode
2) Selecting an internal fixation target
Selecting fixation
target
Normal or SP mode
Stereo mode
: Posterior (CENTRAL)
: Optic disc (DꢀSC)
3) Make sure that the instrument is currently showing the an-
terior segment observation display.
4) Guiding patient’s fixation
: Ask the patient to look at the
center of the fixation target.
5) Aligning:
Anterior segment
observation
Move optical head base as close as possible to you.
Move optical head base leftward/rightward and move main
unit upward/downward to position the pupil image in the
center of the LCD monitor.
Move optical head base to place two working dots in the
anterior segment working dot position aids “( )” shown on
the center of LCD monitor.
Anterior segment
alignment
6) Check the pupil diameter.
Normal or stereo mode (Normal pupil photography):
Pupil diameter: 4.0 mm or greater
SP mode (Small pupil photography):
Pupil diameter: 3.5 mm to 4.0 mm
7) Adjusting photography light intensity:
Change the photography light intensity depending on pupil
diameter.
8) Check that the eyelid is not intruding the pupil area.
9) Press anterior segment button to switch to retinal observa-
tion.
Switching to Retinal
observation display
10) Adjust the observation light intensity.
11) Guide the patient’s fixation.
12) Aligning:
Move optical head base to place two working dots on the
top of the left and right bars in the middle of LCD display.
13) Focusing:
Retinal alignment
Retinal observation
Turn focusing knob to have two focus dots on the display
to form a single line.
Photography
14) Photography: Press shutter button to photograph.
ꢀ6
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6
Operational procedure in photography
6.1.1 Selecting a photography mode
Select a photography mode by pressing “Normal”, “SP”, or “Stereo” button.
Check that the mode you have selected is shown on the upper left corner of LCD monitor.
Normal mode
SP mode
Stereo mode
6.1.2 Selecting an internal fixation target
Use internal fixation target selection button to select an internal fixation target
that you use for retinal observation.
Continuously pressing the button cycles through the targets as shown in the
figure below.
(Cyclic order of internal fixation targets)
Posterior
Optic disc
(DꢀSC)
Macula
(CENTRAL)
(MACULA)
When the photography mode is switched, “CENTRAL” is selected for normal or SP mode while “DISC” is selected for
stereo mode. The internal fixation target you have selected appears on the lower right corner of LCD monitor.
(See the figures of normal, SP, and stereo modes shown in “6.1.1 Selecting a photography mode”.)
ꢀꢁ
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6.1 Normal, SP, and stereo modes
6.1.3 Checking anterior segment observation display
Make sure that “ANTERIOR” is shown in the upper part of LCD monitor.
Press anterior segment button when “ANTERIOR” is not shown.
6.1.4 Guiding patient’s fixation
ꢀnstruct the patient to look straight ahead.
Perform the step described in “6.1.5 Alignment”. Ask the patient to look straight ahead at the green illuminating spot
when the patient’s pupil becomes shown in the center of LCD monitor.
When failed to complete the patient’s fixation by using the internal fixation target, use the external fixation target (optional
accessory: K9L-LE57). Refer to “7.2 external fixation target” for details of connecting and operating the external fixation
target.
6.1.5 Aligning
Pull the optical component as close as possible to you and move the optical
head base leftward/rightward or upward/downward in order to capture the
pupil at the center of the LCD monitor.
Beginning of alignment
Rotate focusing knob until the black line engraved on the knob faces upwards.
Focusing knob position
After the pupil image is captured successfully, move the optical head base
forward until two working dots come in two pairs of round brackets “( )”.
Alignment completed
ꢀ8
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6
Operational procedure in photography
6.1.6 Checking pupil diameter
Check the condition of dilation by comparing the patient’s pupil diameter against the pupil diameter aid.
Change the photography light intensity as required depending on the mydriatic state.
If the patient’s pupil diameter is smaller than that shown by the pupil diameter aid, press SP mode button to proceed to
small pupil photography.
Photography light
intensity
0
+1
Insufficient for photography
Normal mode
Stereo mode
Pupil diameter:
4 mm or greater
SP mode
Pupil diameter:
3.5 mm to 4 mm
In case of the above insufficient for photography, make the room darker, or take more time to get accustomed to
darkness so that the pupil’s dilation can be facilitated.
x
x
It would be difficult to capture a clear image when the pupil diameter is insufficient. However it may not be appli-
cable to some patients.
6.1.7 Adjusting photography light intensity
Change the photography light intensity by the exposure compensation knob
as needed depending on the condition of dilation.
Exposure compensation knob
The photography light intensity is automatically set to the standard level sufficient for each photographing pro-
cedure. However, each patient’s mydriatic state and iris color may cause excessive or insufficient light intensity.
When excessive or insufficient light intensity occurs, use exposure compensation knob to compensate the inten-
sity. The LCD monitor shows the current light intensity setting as a guideline. Rotating exposure compensation
knob to one step up or down changes 1/2 step of exposure value.
x
ꢀ9
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6.1 Normal, SP, and stereo modes
6.1.8 Checking eyelids and eyelashes
The eyelids or eyelashes intruding the pupil area interferes photography.
In such a case,
•
•
Instruct the patient to widely open his or her eyes, or
You or your assistant help the patient keep the eye wide open.
OK
OK
NG
6.1.9 Switching from anterior segment observation to retinal observation
After alignment of the anterior segment is completed, press anterior segment
button to switch to retinal observation.
When you want to go back to anterior segment observation, press the button
again.
anterior segment button
“ANTERIOR” and the pupil diameter aid of the LCD monitor disappear during retinal observation. Anterior segment work-
ing dot position aids “
” changes to retinal working dot position aids “
”, and the focus dots appears.
Normal mode
SP mode
Stereo mode
For stereo mode observation, move the photography target to the center of the LCD monitor.
20
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6
Operational procedure in photography
6.1.10 Adjusting observation light intensity
Retinal observation light intensity
control knob
Adjust the image brightness by retinal observation light intensity control knob
when the retinal image, focus dots, and working dots are not clearly shown.
For details of LCD monitor brightness and contrast adjustment, refer to “9.4.6
MONITOR BRIGHTNESS / CONTRAST”.
6.1.11 Guiding patient’s fixation
The fixation target position changes when anterior segment observation is
switched to retinal observation. ꢀn order for the patient to stare at the selected
internal fixation target, guide the patient’s fixation to the internal fixation target
by asking the patient to look at the green light.
Right eye Left eye
Posterior
Optic disc
Near center
Left Right
Patients would recognize the fixation target at the locations shown in the right
table depending on whether the right or left eye is examined and which fixation
target position is selected.
Center of
macula
Center
6.1.12 Aligning
Move the optical head base slightly until the sizes of the two working dots become the smallest and the dots are aligned
on the top of the left and right retinal working dot position aids “ ” in the LCD monitor as shown in the figure below.
The focus of the two working dots may be fine tuned by moving the control lever forward/backward.
Retinal work-
ing dot posi-
tion aid
Working dot
6.1.13 Focusing
Turn focusing knob to have two focus dots “
” on the display to form a single line.
Focus dots
6.1.14 Photography
After alignment and focusing are completed, photograph by pressing shutter button.
Pictures will be stored in the connected PC. For viewing and analyzing the pictures using a PC, refer to “Installation
manual (filing software)”.
2ꢀ
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6.1 Normal, SP, and stereo modes / 6.2 Precaution for continuous photography / 6.3 Terminating photography
6.2 Precautions for continuous photography
Please note that the LCD monitor automatically switches back to anterior segment observation. *3 When you continue
photographing, note the precautions described below.
k
3 You may disable the anterior segment observation auto-return function by changing the setting.
For details of the setting, refer to “9.4.4 EXTERNAL ALIGNMENT:NORMAL” and “9.4.5 EXTERNAL ALIGNMENT:
MOSAIC”
6.2.1 Pupil diameter
When you continuously photograph, the pupil is constricted due to the flash light in the previous photography. In such a
case, wait for a while and make sure that the pupil diameter is sufficient for photography.
6.2.2 Photographing the other side of eye
When continuously photographing the other side of the eye, pull optical head base toward you so that it will not contact
the patient’s eye or nose and then move the digital camera toward the other side.
Do not increase the photography light intensity more than required.
x
Otherwise the patient may experience pain and his or her eye may be injured.
6.3 Terminating photography
•
Turn OFF the power switch of this instrument (place it in “ ” position), exit the filing software, and turn OFF the PC. Refer
q
to “Instruction manual (filing software)” or the PC’s “Instruction manual” for how to terminate the PC.
Place the lens cap on the objective lens.
Move optical head base back to initial position where optical head base is positioned just above the power supply and
fix it there by tightening the moving component fixing screw.
•
•
•
Place the dust cover over the instrument.
22
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7 Advanced photography
7.1 Mosaic mode photography
Mosaic mode photography has its own internal fixation target selection and positioning different form that of Normal or SP
mode.
ꢀn this section only these differences are described.
k
Preparing this instrument
Preparations for patient’s eye examination
k
Preparations for
photography
Turn ON the power
switch
k
Press mosaic button and check that “MOSAIC” appears
on LCD monitor.
1) Checking the photography mode
Normal mode
SP mode
Checking the selected
photography mode
: NORMAL
: SMALL PUPꢀL
Selecting a fixation
target
2) Selecting an internal fixation target
3) Make sure that the instrument is currently showing anterior
segment observation display.
4) Guiding patient’s fixation
: Ask the patient to look at the
center of the fixation target.
5) Alignment:
Move optical head base as close as possible to you.
Move optical head base leftward/rightward and move
optical component upward/downward to position the
pupil image in the center of the LCD monitor.
Move optical head base to place two working dots in
the anterior segment working dot position aids “( )”
shown on LCD monitor.
Anterior segment
observation
Anterior segment
alignment
6) Check the pupil diameter:
Normal mode (Normal pupil photography)
Pupil diameter: 4.0 mm or greater
SP mode (Small pupil photography):
Pupil diameter: 3.5 mm to 4.0 mm
7) Adjusting the light intensity:
Change the photography light intensity depending on pu-
pil diameter.
8) Check that the eyelid is not intruding the pupil area.
9) Press anterior segment button to switch to retinal observa-
tion.
Switching to retinal observation
10) Adjust the observation light intensity.
11) Guide the patient’s fixation.
12) Alignment:
Retinal alignment
Position optical head base in the place where you
can obtain the retinal image most clearly.
Retinal observation
13) Focusing:
Turn focusing knob to have two focus dots on the display
to form a single line.
Photography
14) Photography: Press shutter button to photograph.
23
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7.1 Mosaic mode photography
7.1.1 Selecting mosaic mode photography
Press mosaic button (the button above “MENU” button).
You can switch between Normal mode and SP mode during mosaic mode
photography.
7.1.2 Selecting an internal fixation target
Internal fixation target selection button becomes disabled during mosaic mode photography. Mosaic mode photography
MANUAL
has two types of internal fixation target setting methods, “AUTO” and “
” settings.
In “Auto mode setting”, one of the internal fixation targets is sequentially selected in the predefined order.
In “Manual setting”, an internal fixation target is selected manually by pressing one of the keys corresponding to the pho-
tographing parts of the eye.
The default setting is “Auto mode setting”.
For changing the setting, refer to “9.3 Mosaic internal fixation target setting (Switching internal fixation target in
mosaic mode photography)”.
L
Switching the internal fixation target in mosaic mode photography – Use in auto mode
Anterior segment observation display
Retinal observation display
The position of the anterior segment working dot position aids on anterior segment observation display changes
depending on the photographing part of the eye.
In auto setting, one internal fixation target is automatically switched to another after completing each photography and
the corresponding photographing part of the eye is also changed consequently.
When you want to photograph again because of poor photo quality, press the left key of the menu buttons.
The internal fixation target that corresponds to the last photographing part illuminates.
When you do not need to photograph the area currently selected, press the right side button of the menu button. This
switches the current part to the next photographing part and the internal fixation target that correspond to the next
photographing part illuminates.
1a to 9a shown on the bottom of LCD monitor indicate the mosaic mode photography sequence selected in menu
mode. When a photograph is taken, the corresponding number becomes highlighted. Pressing shutter button by
mistake while observing anterior segment does not allow the next photographing part to appear since an image
capturing must be repeated again.
For details of the mosaic mode photography sequence setting, refer to “9.3.2 Setting of auto mode”.
24
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7 Advanced photography
L
Switching the internal fixation target in mosaic mode photography – Use in manual mode
Anterior segment observation display
Retinal observation display
Select manual mode in order to select the photographing parts of your
choice in mosaic mode photography.
For details of the setting, refer to “9.3 Mosaic internal fixation
target setting (Switching internal fixation target in mosaic mode
photography)”. Connect a numerical keypad (optional accessory) that
allows you to select internal fixation target positions of your choice.
Turn ON num lock of the connected numerical keypad.
g
Num
Lock
/
8
5
2
00
BS
7
4
1
0
9
6
3
Enter
Optional accessory
Keys of a numerical keypad are used to select internal fixation target positions in manual setting. Relationship
between the keys and the internal fixation target positions is shown below.
Keys of numerical keypad
(Shaded keys are invalid.)
Right eye
Left eye
The numbers from 1 to 9 that appear on the bottom of the display indicate photographing parts of the eye (and keys
of numerical keypad). When a photograph is taken, the corresponding number becomes highlighted.
The highlighting is cleared when the optical head base is moved to switch the eye to be examined to the other side of
eye.
25
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7.1 Mosaic mode photography
7.1.3 Aligning and focusing
In mosaic mode photography, align for anterior segment observation only, switch to retinal observation without changing
the position of the instrument, check that the patient eye is correctly fixed, and photograph.
However when you see an excessive flare during retinal observation, position the digital camera appropriately before
photographing.
For mosaic mode photography, the alignment position in anterior segment observation appears in different positions as
shown in the figures below. Align appropriately so that the working dots fit within the anterior segment working dot posi-
tion aids.
“FIX TARGET” that indicates the eye fixation direction for you to direct a patient or the position of the internal fixation tar-
get visible from a patient appears on the lower right of LCD monitor during retinal observation.
Tell the patient the direction shown on the display and guide the patient’s fixation.
Please note that some photographing parts may not clearly show the focus dots. In such a case, perform focusing using
macula and photograph other photographing parts without re-focusing. However you may re-focus when you can see the
focus dots clearly.
26
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7 Advanced photography
7.2 External fixation target
When failed to complete fixation of the patient’s eye using the internal fixation target, use the external fixation target (op-
tional accessory: K9L-LE57) to enable the fixation using the other eye.
7.2.1 Installing the external fixation target
1
Aligning the groove on the external fixation target mount and the chin rest, tighten two mounting screws to lock the lamp.
2 Adhere attached cable clamps at two places shown in the figure and fix the cable with the cable clamps.
3 Insert the cable into the external fixation target connecting terminal.
1
2
3
7.2.2 Using the external fixation target
The external fixation target illuminates by turning on the button installed on
the cable.(When it is turned ON, the internal fixation target turns OFF.) “EXT”
appears on the lower right corner of LCD monitor when the external fixation
target is in use.
7.3 Diopter compensation range
When clear focus can not be obtained by focusing, pull out diopter
compensation knob.
Pulling out diopter compensation knob to the first stop enables the minus
diopter compensation (D-) while pulling out to the second stop enables the
plus diopter compensation (D+). Slowly pull out the knob until it cricks when it
comes into one of the diopter lens insert positions. When you stop pulling the
knob before it cricks, you can not obtain a good image.
The minus or plus diopter compensation is indicated on the upper right corner
of LCD monitor.*4
The focusing range of each compensation position is shown below.
-1
-1
−
No diopter lens
12 m (D) to +13 m (D)
k
4
Plus diopter compensation
Minus diopter compensation
+ 10 m-1(D) to +35 m-1(D)
-1
-1
−
−
32 m (D) to 10 m (D)
Adjust the focus using the retinal image on the LCD monitor since focus dots
do not appear when diopter compensation lens is in use.
2ꢁ
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Troubleshooting
8
Examples of retinal photograph
Possible cause
Remedies
Dark shadow or bright reflection
appears at the top or bottom of the
image.
The instrument is positioned
too high to the patient’s eye.
Perform all alignment steps to obtain a clear
retinal image with consistent brightness. De-
pending on the patient’s eye fixation condi-
tion, you may obtain a good image by locating
working dots away from the dot position aid.
The instrument is positioned
too low to the patient’s eye.
Perform all alignment steps to obtain a clear
retinal image with consistent brightness. De-
pending on the patient’s eye fixation condi-
tion, you may obtain a good image by locating
working dots away from the dot position aid.
Dark shadow or bright reflection
appears at the left or right of the
image.
The instrument is positioned
too right or left to the patient’s
eye.
Check that diopter compensation knob is in
the correct position by slowly moving the knob
to see if it cricks.
Diopter compensation knob is
not in click.
Peripheral area become whitened.
Locate the digital camera to the position
where working dots become smallest. When
flares still persist, pull the digital camera a
little or move the optical component to the
patient. (Working dots may be fades a little.)
The instrument is positioned
too close to the patient’s eye.
The instrument is positioned
too far from the patient’s eye.
The image is too dark.
Turn exposure compensation knob to +1 or
+2 position. If the patient’s pupil diameter
equal to or smaller than that shown by the
working dots, press SP mode button and
photograph in SP mode.
The pupil diameter is small.
The image is out of focus or
blurred.
Avoiding the area of white turbidity during
alignment may allow you to obtain a good im-
age.
The patient has developed a
cataract.
The corneal surface is dry.
The objective lens is dirty.
Ask the patient to blink before imaging.
The image become whitened lo-
cally.
Clean the objective lens.
Refer to “10. Maintenance and inspection”
for details of the objective lens cleaning.
The lower area become whitened.
Ask the patient to open his/her eyes wide so
that the eyelid or eyelashes do not intrude
the area of the pupil, or you or your assistant
help the patient keep the eye wide open.
The eyelid or eyelashes intrude
the imaging area.
28
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8 Troubleshooting
ꢀrregularity
Possible cause
Remedies
Adjust the focus using the retinal image since
focus dots do not appear when a diopter com-
pensation lens is in use.
A diopter compensation lens is
inserted.
Focus dots do not appear.
Set the shutter speed of digital camera to 1/25 sec.
The flash lamp turns on but a black
image or partially chipped image is
obtained.
The shutter speed of digital
camera is not set to 1/25 sec.
k
Refer to “12 Technical information”.
Set the digital camera to manual mode.
The digital camera is not set to
manual mode.
k
Refer to “12 Technical information”.
The flash lamp does not turn ON
and no image is captured.
Fully insert the trigger cable to the end.
Fully insert the USB cable to the end.
Fully insert the synchronous cable to the end.
Trigger cable is not fully insert-
ed.
Although image are successfully
captured and shown on the LCD
monitor of the digital camera, the
monitor of the PC presents no im-
age.
The USB cable is not fully in-
serted.
ꢀmages are captured without flash The synchronous cable is not
lamp turned on.
fully inserted.
29
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8 Troubleshooting
ꢀrregularity
Possible cause
Remedies
The error message below is dis-
played on the LCD monitor.
ERROR 1 : HꢀGHER VOLTAGE
POWER OFF AND CALL SER-
VꢀCE PERSON
Charged voltage exceeded the
limit. There could be a failure
of an internal circuit.
Please contact Kowa or your Kowa dealer.
Please contact Kowa or your Kowa dealer.
The error message below is dis-
played on the LCD monitor.
ERROR 2 : LOWER VOLTAGE
POWER OFF AND CALL SER-
VꢀCE PERSON
Charged voltage does not
reach the lower limit. There
could be a failure of an internal
circuit.
The error message below is dis-
played on the LCD monitor.
NOW COOLꢀNG
Cooling has been started since
the recharge circuit tempera-
ture exceeded the higher limit.
This is not a malfunction. Wait for 120 sec-
onds before you resume photography.
PLEASE WAꢀT 120 SEC
30
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9 Menu operation
9.1 Starting menu
Press down “MENU” button center of menu buttons for approx. 2 seconds to access menu
Menu buttons
mode.
Use menu buttons “ , , and ” in menu mode.
,
G H F
E
9.2 Objective lens cleaning lamp
Objective lens cleaning lamp illuminates when you press “
” button to
F
select “ON” while “LAMP FOR LENS CLEANING” is selected. Refer to “10
Maintenance and inspection” for details of the objective lens cleaning.
9.3 Mosaic internal fixation target setting
(Switching internal fixation target in mosaic mode photography)
Internal fixation target switching method is defined in this item.
You can select either manual mode that requires a numerical keypad (optional
accessory) for operation or “Auto mode” which automatically switches the
fixation targets. You also set the illuminating order for auto mode and select
the mirror symmetry of illuminating orders for the left and right eyes.
9.3.1 Settings for manual mode
Press menu button while “MOSAIC INT-FIX” is selected to access the display
shown in the right figure.
Press menu button while “MANUAL” is highlighted to select “MANUAL” and
return to menu item selection.
3ꢀ
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9.1 Starting menu / 9.2 Objective lens cleaning lamp
9.3 Mosaic internal fixation target setting (Switching internal fixation target in mosaic mode photography)
9.3.2 Settings of auto mode
Press menu button while “AUTO” is highlighted to access “MOSAIC INT-
FIX AUTO MODE SETTING”. Pressing menu button while “AUTO MODE
SETTING” is highlighted makes one of the numbers shown under “PHOTO
LOCATION ON THE RIGHT EYE” highlighted and allows you to start setting
the photographing order. The current setting appears first when you access
“AUTO MODE SETTING”.
Use “ ,
,
, and
”
keys to move to the number of your choice.
G H F
E
Select and highlight the number corresponding to the photographing part of
the eye in the order you want to photograph and press menu button to set the
illuminating order.
When you terminate setting, highlight “SET” and press menu button.
When you want to restart the setting, highlight “RESET” and press menu
button.
Also you can select the mirror symmetry of illuminating orders for the left and
right eyes. When you want to apply the mirror symmetry, highlight “MIRROR
SELECTION”, select “YES”, and press menu button. When you do not apply
the mirror symmetry, select “NO” and press menu button.
When you select “YES” for the “ MIRROR SELECTION”, illuminating orders are as shown below.
Setting of illuminating orders
Right eye
Left eye
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9 Menu operation
When you select “NO” for the “MIRROR SELECTION”, illuminating orders are as shown below.
Setting of illuminating orders
Right eye
Left eye
Select “SET” and press menu button in “MOSAIC INT-FIX AUTO MODE SETTING” to save the settings and return to
menu item selection.
When the power supply is turned OFF before pressing “SET”, the settings you have made will not be saved.
9.4 Other setting menu
Press menu button while “OTHER SETTING” is highlighted to access the sub
menu screen for other settings of this instrument.
9.4.1 POWER ON MODE 1
This item allows you to select the photography mode when the instrument is
turned ON.
Setting
NORMAL : Normal mode (Factory setting)
STEREO : Stereo mode
How to set
Press “
” or “
” button to switch the setting while “POWER ON
F
E
MODE 1” is selected. Press menu button while the setting of your
choice is highlighted to select the setting and return to menu item
selection.
33
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9.3 Mosaic internal fixation target setting (Switching internal fixation target in mosaic mode photography)
9.4 Other setting menu
9.4.2 POWER ON MODE 2
This item allows you to select the state of Blue/Brown selection switch when
turning the instrument is turned ON.
Setting
BROWN : Brown eye (Factory setting)
BLUE
: Blue eye
How to set
Press “
” or “
” button to switch the setting while “POWER ON
F
E
MODE 2” is selected. Select “END” and press menu button while the
setting of your choice is highlighted to confirm the setting and return to
menu item selection.
9.4.3 SLEEP MODE
You can select “SLEEP MODE” (power saving mode) as the initial power mode
when the instrument is turned ON. When this instrument is not operated for a
certain period of time (approximately 10 minutes) it goes into “SLEEP MODE”.
In “SLEEP MODE, the LCD” monitor and all lamps of observation illumination
lamps except the chin rest raising and lowering button indicator lamp (the
indicator lamp flashes during “SLEEP MODE”) turn OFF. When you activate
any part of the instrument, it recovers from “SLEEP MODE”.
Setting
ON
: SLEEP MODE (Factory setting)
: Normal mode
OFF
How to set
Press “ ” or “ ” of menu buttons to switch the setting while “SLEEP
F
MODE” is selected.
E
9.4.4 EXTERNAL ALIGNMENT : NORMAL
In normal mode, you can set whether or not the display automatically switches
back to anterior segment observation after photography.
Setting
AUTO
: The display automatically switches back to anterior
segment.
MANUAL : The display does not automatically switch back to anterior
segment.
How to set
Press “
” or “
” button to switch the setting while “EXTERNAL
F
E
ALIGNMENT : NORMAL” is selected. Select “END” and press menu
button while the setting of your choice is highlighted to select the
setting and return to menu item selection.
34
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9 Menu operation
9.4.5 EXTERNAL ALIGNMENT : MOSAIC
In mosaic mode photography, you can set whether or not the display
automatically switches back to anterior segment observation after
photography.
Setting
AUTO
: The display automatically switches back to anterior
segment.
MANUAL : The display does not automatically switch back to anterior
segment.
How to set
Press “
” or “
” button to switch the setting while “EXTERNAL
F
E
ALIGNMENT : MOSAIC” is selected. Select “END” and press menu
button while the setting of your choice is highlighted to select the
setting and return to menu item selection.
9.4.6 MONITOR BRIGHTNESS / CONTRAST
Press menu button while “MONITOR BRIGHTNESS” or “MONITOR
CONTRAST” is selected to display an observation image. Use the image to
set the LCD monitor screen brightness or contrast.
Press “ ” or “ ” key to increase or decrease the brightness or contrast.
G
While looking at the observation image on the LCD monitor, select an
H
appropriate brightness or contrast and press menu button.
9.4.7 Exiting a menu
To exit menu mode, select “END” in any of the menu screen.
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10 Maintenance and inspection
This instrument is a precision instrument and daily maintenance and inspection would affect the imaging results. Please
read the following information carefully in order to use this product correctly and safely.
10.1 Daily maintenance
1. What to do after use:
Turn the power switch OFF
Place the lens cap on the objective lens
Place the dust cover over the instrument
2. Check that no dust, debris, finger print, or body fluid is found on the objective lens.
3. Determine that the objective lens is clean before you start using the instrument the first time each day.
Dirty objective lens is readily identified under the objective lens cleaning lamp (see “9.2 objective lens cleaning
lamp”).
When the objective lens is dirty, follow the steps described in “10.4 Cleaning the objective lens” to clean it.
4. Condensation may occur on the objective lens when the instrument is moved into an environment where there is
temperature difference. When condensation occurs, wait until it disappears before use.
5. When condensation occurs repeatedly, lenses may get moldy.
When such a case has occurred to you, contact Kowa or your Kowa dealer.
6. Disconnect the power supply cable when the instrument is not used for an extended period of time.
10.2 Daily inspection (by users)
Inspect this instrument in accordance with “KOWA nonmyd WX daily inspection table”.
When an anomaly found during the inspection may not be solved using any of the maintenance methods described in
this instruction manual, contact Kowa or your Kowa dealer.
KOWA nonmyd WX daily inspection table
ꢀnspection
Procedure
Acceptability criteria
Visually verify that the cable has no flaw
or damage.
Power cable
Objective lens
Exterior
No flaw or damage should be found.
No dust, debris, fingerprint, teardrop
must be found.
See “10.4 Cleaning the objective lens”.
Visually verify that the exterior has no
flaw, crack, deformation or rust.
Exterior components must have no
flaw, crack, deformation or rust.
Visually verify that the ꢀD plate and la-
bels is readily readable and not contami-
nated.
Rating plates and labels must be read-
able.
Plates and labels
Make the instrument ready for photogra-
phy. Hold your hand in front of the objec-
tive lens. Push the shutter button and
visually verify that the flash light emitted
through the objective lens illuminates the
hand (do not look into the objective lens).
Pressing the shutter button must acti-
vate the flash lamp to emit the light.
Shutter button and flash lamp
36
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10 Maintenance and inspection
10.3 Regular inspection (by manufacturer)
In order to use this instrument safely over its useful life, we recommend you to have it inspected annually. Contact Kowa
or your Kowa dealer for details and cost of inspections.
1. External components and their installation
2. Optical components
3. Operations and functions of components
4. Photograph quality inspection using standard model eye (0D)
5. Photography light intensity
10.4 Cleaning the objective lens
You can not obtain a good image if the objective lens is contaminated with fingerprints, etc. Clean the lens as described
below:
1 Turn ON power switch.
2 In order to identify soils on the objective lens clearly, reduce room’s luminance, and turn ON the objective lens
cleaning lamp.
(Refer to “ 9.2 Objective lens cleaning lamp” for details of how to turn ON the objective lens cleaning lamp.)
3 Using high-pressure air, blow off debris or dust.
4 When the air does not clean the objective lens, moisten soft cloth or
cleaning paper with cleaning solution made from ethyl alcohol and ether
(1:1) and clean the lens starting from its center in a circular motion.
Tips for lens cleaning
x
Do not reuse soft cloth or cleaning paper but use new soft cloth or cleaning paper moistened with cleaning solu-
tion to obtain the best results.
k
k
k
Cleaning the lens without removing soils or applying a strong force when wiping may scratch the lens surface.
Do not use chamois leather, silicon cloth, or eyeglass cleaner paper, etc.
Carefully store and handle the flammable and combustible cleaning solution.
5 If any soil is left out after cleaning with the cleaning solution, gently wipe off the soiled area with a cotton swab soaked
with a little amount of water. After this cleaning step, wipe the lens using the cleaning solution described above.
Should you have stubborn soil that cannot be removed by the steps above, contact Kowa or your Kowa dealer.
6 Turn OFF the objective lens cleaning lamp after the lens cleaning is completed.
3ꢁ
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10.3 Regular inspection (by manufacturer) / 10.4 Cleaning the objective lens
10.5 Disinfection / 10.6 Outer cleaning / 10.7 Replacing flash lamp
10.5 Disinfection
Wipe the forehead rest with rubbing alcohol as soon as a patient completes the examination. Also wipe the chin rest with
rubbing alcohol when no chin rest paper is used.
10.6 Outer cleaning
Do not wipe the outer surface of the instrument with solvents
such as benzene, alcohol, thinner, ether. Such substances may
cause the surface to be discolored or deteriorated.
Caution
Prohibitory
Wipe the outer surface with soft cloth, from which water (used to moisten the cloth) was firmly squeezed off.
Lightly wipe the LCD monitor screen cover with soft cloth such as gauze because it is easily damaged.
Wipe off the obstinate dirt with soft cloth, from which water or lukewarm water used to dilute a small amount of
neutral detergent was squeezed off.
x
x
10.7 Replacing flash lamp
When replacing the flash lamp, make
sure the instrument is turned OFF and un-
plugged from the power outlet.
Warning
Warning
High-Voltage
Unplug
Otherwise, there may occur electrical shock.
This instrument is equipped with a storage
capacitor for photography light. Replacing the
flash lamp while this capacitor is still not yet
fully discharged causes a danger of an electric
shock. Check that the discharge indicator LED
is turned OFF before replacing the flash lamp.
Warning
Warning
High-Voltage
Unplug
Do not replace the lash lamp immediately af-
f
ter turning the instrument OFF. You could be
burned by a lamp heated to a high temperature.
Allow 10 minutes to cool it down before re-
placing.
Caution
Caution
High-temperature
Prohibitory
Do not touch the flash lamp bulb with your bare hands. Other-
wise, the lamp may reduce the light intensity and longevity.
Caution
Prohibitory
38
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10 Maintenance and inspection
1 Rotate control lever to move optical head to the uppermost location.
2 Turn OFF the power switch and unplugged from the power outlet.
3 Loosen lamp cover screws with a coin or a screwdriver and then remove
lamp cover.
Make sure that the flash lamp has been cooled down before proceeding to
the next step.
4 Check that the discharge indicator LED shown in the figure is completely
turned OFF.
Discharge
indicator
LED
It normally turns OFF completely within three minutes after the instrument
is turned OFF. If it does not turn OFF even after above period of time,
contact Kowa or your Kowa dealer as it may carry a risk of failure.
In such a case, never touch the instrument.
k
Discharge indicator LED illuminates only when it discharges after the
instrument is turned OFF.
5 After the discharge indicator LED is turned OFF and the flash lamp is fully cooled down (about 10 minutes after the
power is turned OFF), unscrew two screws by a screwdriver and remove the flash lamp socket.
6 Hold the lamp and its socket in your hand, remove the flash lamp, and
install a new lamp in the socket.
k
When replacing the flash lamp, pull straight out and push straight in the
bulb towards the direction of electrode pin. Do not twist the flash lamp
when fitting or removing it.
k
Fully insert the flash lamp to the end of the socket.
k
Do not touch the flash lamp bulb.
7 Tighten two screws of the flash lamp socket with a driver. Pay attention not to pinch the cables around the instrument
when installing the flash lamp socket.
8 Place lamp cover and tighten lamp cover screws with a coin or a driver.
k
When installing the lamp cover, make sure that the cable of the illumination lamp socket is snugly housed within
the external sheath.
9 Connect the power supply cable plug to the power outlet and turn ON the power switch.
0 Turn ON the instrument and perform test photography.
39
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10.7 Replacing flash lamp / 10.8 Fuse replacement /
10.9 Refilling and replacing consumables
10.8 Fuse replacement
When replacing the fuse, make sure the instru-
ment is turned OFF and unplugged from the
power outlet.
ꢀf the fuse holder cover is removed with the in-
strument unplugged, there may occur electrical
shock.
Warning
Warning
High-Voltage
Unplug
Use a designated fuse only.
Otherwise, the instrument may malfunction or a fire may break
out.
Warning
Obligatory
1 Turn OFF the power switch and pull the plug from the power outlet.
2 Make sure that the instrument is turned OFF and wait for discharge at least 5 minutes for safety.
3 Press down the fuse holder with a screwdriver and turn the fuse holder to the direction of the arrow (counterclockwise)
for removal.
4 Pull the old fuse and replace it with a new one. Make sure that the fuse
type and rating are correct.
5 Press down the fuse holder with a screwdriver and turn the fuse holder to
the opposite direction of the arrow (clockwise) and install it in place.
6 Connect the power cable plug to an power outlet.
10.9 Refilling and replacing consumables
Order spare parts by purchase order numbers listed below to Kowa or your Kowa dealer.
Part name
Purchase order number
Flash lamp
Fuses
K9L39FU
21802.5M
(T2.5AL250V)
Chin rest paper
K9L-TB45#102
K9L-TB45#101
AFT2#179
Chin rest paper retaining pin
Dust cover
40
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11 Specifications
Shooting mode
Normal / SP / Stereo (electrically switched)
Stereoscopic photography method
Stereo photography parallax
Simultaneous stereo photography
7.4° (at the 0 diopter eye)
Normal mode
SP mode
Stereo mode
: 45°
: 45°
: 34° (20° horizontal and 27° vertical directions)
Field angle
*
Some eyes may cause a flare around their circumference.
Normal image
: S ( 9 μm ± 7 %)
*
L (4.5 μm ± 7 %)
*
Tolerance of pixel pitch on fundus
(ꢀSO 10940)
Stereo image
30 mm
: S (5.5 μm ± 7 %)
*
L (2.7 μm ± 7 %)
*
Working distance
Normal mode
SP mode
Stereo mode
:
:
:
4.0 mm
3.5 mm
4.0 mm
Minimum pupil size
Without compensation
Compensation +
Compensation −
: −12 m-1(D) to +13 m-1(D)
Compensation range of
examined eye
: +10 m-1(D) to +35 m-1(D)
: −32 m-1(D) to −10 m-1(D)
Focusing
Split luminous bars coincidence
2 luminous dots indication type
Working distance adjustment
Camera
Monitor
Specific Nikon digital SLR camera
5.7-inch LCD monitor
Observation
Photography
: Near-infrared LED
: Xenon flash lamp
Light source
Internal fixation target
Central, Disc, Macula,mosaic 8 positions
Movable 40mm forward/backward
Movable 98mm leftward/rightward
Movable 27mm vertically (electric)
Optical head base adjustment range
Chin rest adjustment range
ꢀnterfaces
Movable 55mm (electric)
ꢀmage output
ꢀmaging conditions output
Numerical keypad input
: USB (B type)
: USB (mini-B type )
: USB (A type)
Input
Power consumption
: AC100-240V, 50/60Hz
: 150VA
Power supplies
Dimensions
Weight
310(W)x504(D)x548(H)mm
21kg / 46lbs (excluding the attached digital SLR camera)
*S/L : ꢀmage size set on the digital camera
Compliance standard
• EN 60601-1:1990+A1:1993+A2:1995
• EN 60601-1-2:2001+A1:2006
Classification of equipment based on EN 60601-1
• According to the type of protection against electric shock
(Class device)
• According to the degree of protection against electric shock
(Type B applied part)
• According to the type of protection against ingress of water as detailed in the current edition of ꢀEC60529.
(ꢀPX0)
• According to the degree of safety of application in the presence of a flammable anaesthetic mixture with air or with
oxygen or nitrous oxide.
(Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with
oxygen or nitrous oxide)
• According to the mode of operation.
(continuous operation)
Complied EC Directive
Medical Device Detective 93/42/EEC :
WEEE Directive 2002/96/EC
4ꢀ
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12 Technical information
12.1 Description of digital camera
Release mode button
Set the mode to “ S ”
Mode dial
Set the mode to “M”
Main command dial
Set the shutter speed to 1/25.
Multi selector
Move up
Move to the lower
hierarchy, Confirm
Move down
Move to the upper
hierarchy, Chancel
Focus-mode selector
Set the mode to “M”
Menu button
Focus selector lock
Set the selector to “L”
AF
M
Menu hierarchy
SHOOTꢀNG MENU
Standard
Sharpening
Contrast
Brightness
Saturation
Hue
Set picture control
Image quality
ꢀmage size
White balance
ꢀSO sensitivity settings
Color space
Long exp. NR
High ꢀSO NR
CUSTOM SETTꢀNG MENU
SETUP MENU
42
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12 Technical ꢀnformation
12.2 digital camera setting
Ensure that the digital camera settings are correctly configured.
Dial setting
Custom menu
Menu items
Mode dial
Setting
M
Menu items
No memory card?
Setting
LOCK
Focus-mode selector
Focus selector lock
Shutter speed *5
M
L
Set-up menu
1
/
25
Menu items
Language
Setting
English
k
5 Use Main command dial to set the shutter speed.
Photography menu
Release mode
Menu items
Set picture control
Sharpening
Setting
Menu items
Setting
Standard
Release mode
Single frame
+4
Contrast
0
Brightness
Saturation
0
k
6
You may change photo quality mode and ꢀm-
−1
+2
age size at your discretion.
Hue
ꢀmage quality
: FINE, NORMAL, BASIC
: L, M, S
Image quality*6
ꢀmage size*6
FINE
Image size
S (2144×1424)
color temperature setting
5560(A4,M1)
White balance
ꢀSO sensitivity settings
Color space
400
sRGB
OFF
Long exp. NR
High ꢀSO NR
OFF
Do not turn OFF the digital camera when communication is ongoing between the digital camera and the PC.
x
x
The items not shown above may use their default settings.
43
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12.2 digital camera setting / 12.3 ꢀmaging condition output
12.3 Imaging conditions output
This instrument outputs the imaging conditions from ꢀmaging condition output terminal. ꢀf you want to read the imaging
conditions using application software other than that provided with the instrument, refer to the specifications below:
For this purpose, you need to install FTDI “Direct (D2XX) driver Ver 2.04.06 or later” into your PC to which this instru-
ment is connected.
Communication related specifications
Baud rate
Data length
Parity
: 38400
: 8 bit
: even
: 1 bit
Stop bit
Flow control
: none
Output data
Output item
Description
Example
K9L57
Model name
Fixed value
10-digit number
ꢀnstrument number
Photography mode
16174
]]]]]
NORMAL/SP/STEREO
STEREO
0
Light intensity selector knob
position
-2/-1/0/+1/+2
Blue or brown eye
Diopter compensation
Left or right eye
BLUE/BROWN
0/D+/D-
BLUE
0
L/R
R
Fixation target
1 to 7/EXT
1 to 7
C (Posterior), N (optic disc), M (Macula), U (Up)
UR (Upper right), UL (Upper left), R (Right), L (Left), D (Down),
LR (Lower right), LL (Lower left)
Internal fixation target illuminat-
C
ing position
Observation screen
ANTE/FUNDS
FUNDS
k
A linefeed code is inserted every output of an item.
44
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13
Electromagnetic compatibility (IEC60601-1-2)
This instrument is a medical electrical instrument. Medical electrical instruments are requireed special attention to the
electromagnetic compatibility (EMC). The following section describes the EMC and precautions regarding this instrument.
When installing or using this instrument, read the description carefully and follow the directions described.
(The EMC of this instrument was tested based on ꢀEC60601-1-2.)
1. Please note that portable- or mobile-type radio frequency communication devices (RF communications instrument)
may adversely affect this instrument resulting in malfunctioning.
2. The electromagnetic compatibility (EMC) of this instrument was tested with the options and accessories shown below.
Since using an option or accessory other than those specified may cause malfunctioning of this instrument due to
interferences of other device or cause malfunctioning of other device, use only the options or accessories specified
for this instrument.
100V power supply cable
120V power supply cable
230V power supply cable
PC
: KP300VCTF3X1.25SQKS16A, 2.5 m
: KP320SJT18X3KS31, 2.5 m
: KP-4819Y KS-31A, 2.5 m
: CE Marking, VCCI, and FCC approved PC
: 3 m
●
●
●
●
●
●
●
●
USB cable (Type A-B)
USB cable (Type A-Mini- B) : 3 m
Numerical keypad
External fixation target (K9L-LE57)
3. This instrument is not designed such that it can be used adjacent to other instrument or placing one on top of another.
Therefore, do not apply such use. Nevertheless, if such use is inevitable, it is necessary to monitor constantly if the
instrument is functioning normally after such use has been adopted.
4. Accessories and options used with this instrument are tested for EMC when combined with instrument below. Since
using with an instrument other than that specified may cause malfunctioning of this instrument due to interferences of
other devices or cause malfunctioning of other devices, do not use any instrument other than specified below.
Option 1: CE Marking, VCCI, and FCC approved PC
5. We specified the functions listed in the table blow as the basic performance of this instrument to determine EMC of
this instrument.
Functions
Essential performance
Light-emitting function
ꢀllumination light intensity setting and switching
ꢀllumination light intensity settings
Charge function
Light-emitting functions
Optical head vertical movement
Chin rest vertical movement
Anterior segment/retinal switching
Normal mode switching
SP mode switching
ꢀnstrument operation functions
Stereo mode switching
Anterior segment illumination
Retinal observation light intensity adjustment
W.D. ON/OFF
F.D. ON/OFF
Photography functions
ꢀmage signal output
LCD monitor screen display (OSD)
LCD monitor screen display (through image)
LCD monitor display functions
45
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13 Electromagnetic compatibility (ꢀEC60601-1-2)
[Compliance verification and guidance]
Guidance and manufacturer’s declaration - electromagnetic emissions
KOWA nonmyd WX is intended for use in the electromagnetic environment specified below.
The customer or the user of KOWA nonmyd WX should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
KOWA nonmyd WX uses RF energy only for its internal function. There-
fore, its RF emissions are very low and are not likely to cause any interfer-
ence in nearby electronic instrument.
Group 1
CꢀSPR 11
RF emissions
Class B
Class B
CꢀSPR 11
Harmonic emissions
ꢀEC 61000-3-2
KOWA nonmyd WX is acceptable in all types of facilities without any limita-
tion to the electrical supply network connected to KOWA nonmyd WX.
Voltage fluctuations/
flicker emissions
ꢀEC 61000-3-3
Complies
Guidance and manufacturer’s declaration - electromagnetic immunity
KOWA nonmyd WX is intended for use in the electromagnetic environment specified below.
The customer or the user of tKOWA nonmyd WX should assure that it is used in such an environment.
ꢀmmunity test
ꢀEC60601 test level
±6kV contact
Compliance level
±6kV contact
Electromagnetic environment - guidance
Electrostatic
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30%.
discharge(ESD)
ꢀEC61000-4-2
±8kV air
±8kV air
±2kV for power
supply lines
±2kV for power
supply lines
Electrical fast
transient/burst
ꢀEC61000-4-4
Mains power quality should be that of a typical
±1kV for
±1kV for
commercial or hospital environment.
input/output lines
input/output lines
±1kV
±1kV
Surge
differential mode
±2kV
differential mode
±2kV
Mains power quality should be that of a typical
ꢀEC61000-4-5
commercial or hospital environment.
common mode
common mode
T
T
<5% U
T
(>95% dip in U )
<5% U
T
(>95% dip in U )
for 0.5 cycle
for 0.5 cycle
T
T
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
40% U
T
(60% dip in U )
40% U
T
(60% dip in U )
Mains power quality should be that of a typical
commercial or hospital environment. ꢀf the user
of KOWA nonmyd WX requires continued opera-
tion during power mains interruptions, it is rec-
ommended that KOWA nonmyd WX be powered
from an uninterruptible power supply.
for 5 cycles
for 5 cycle
T
T
70% U
T
(30% dip in U )
70% U
T
(30% dip in U )
ꢀEC61000-4-11
for 25 cycles
for 25 cycle
T
T
<5% U
T
(>95% dip in U )
<5% U
T
(>95% dip in U )
for 5 sec
for 5 sec
Power frequency
(50/60Hz)
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
3 A/m
3 A/m
magnetic field
ꢀEC61000-4-8
T
NOTE U is the a.c. mains voltage prior to application of the test level.
46
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13 Electromagnetic compatibility (ꢀEC60601-1-2)
Guidance and manufacturer’s declaration - electromagnetic immunity
KOWA nonmyd WX is intended for use in the electromagnetic environment specified below.
The customer or the user of KOWA nonmyd WX should assure that it is used in such an environment.
ꢀmmunity test
ꢀEC 60601 test level
Compliance level
Electromagnetic environment– guidance
Portable and mobile RF communications instru-
ment should be used no closer to any part of
KOWA nonmyd WX, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter.
Recommended separation distance
d=1.2
P
Conducted RF
ꢀEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3 V
d=1.2
d=2.3 P 800 MHz to 2.5 GHz
P
80 MHz to 800 MHz
Radiated RF
ꢀEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m
where P is the maximum output power rating
of the transmitter in watts (W) according to the
transmitter manufacturer and d is the recom-
mended separation distance in metres (m).
Field strengths from fixed RF transmitters, as
a
determined by an electromagnetic site survey ,
should be less than the compliance level in
each frequency rangeb.
ꢀnterference may occur in the vicinity of instru-
ment marked with the following symbol:
NOTE 1
NOTE 2
At 80MHz and 800MHz, the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the KOWA nonmyd WX is used exceeds the applicable RF compliance level above, the
KOWA nonmyd WX should be observed to verify normal operation. ꢀf abnormal performance is observed, additional measures
may be necessary, such as reconfiguring or relocating the KOWA nonmyd WX
b
Over the frequency range 150kHz to 80MHz, field strengths should be less than 3 V/m.
Recommended separation distances between
portable and mobile RF communications instrument and KOWA nonmyd WX
KOWA nonmyd WX is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The cus-
tomer or the user of KOWA nonmyd WX can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications instrument (transmitters) and KOWA nonmyd WX as recommended below, according to the
maximum output power of the communications instrument.
Separation distance according to frequency of transmitter
Rated maximum output
m
power of transmitter
W
150 kHz to 80 MHz
d=1.2
0.12
80 MHz to 800 MHz
d=1.2
0.12
800 MHz to 2.5 GHz
P
P
P
d=2.3
0.01
0.1
1
0.23
0.37
1.2
3.7
12
0.37
1.2
3.7
12
0.74
2.3
7.4
23
10
100
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can
be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1
NOTE 2
80MHz and 800MHz, the separation distance for the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
4ꢁ
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(World Sales Headquarters)
4-14, Nihonbashi-honcho 3-chome, Chuo-ku, Tokyo 103-8433 Japan
ꢀmmermannstrasse 43B
Phone: 81(3) 3279-7639
Facsimile: 81(3) 3279-7541
40210 Duesseldorf, F.R. Germany
Phone: 49(211) 1793540
Facsimile: 49(211) 161952
Hamamatsu Factory
3-1, Shinmiyakoda 1-chome, Kita-ku, Hamamatsu city, Shizuoka Pref., 431-2103 Japan
© 2010 Kowa Company, Ltd. All rights reserved.
K9L57 V1.0 E 100507
Printed in Japan
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