Kowa Ophthalmic Diagnostics VX 10a Manual
Kowa Ophthalmic Diagnostics VX 10a Manual
KOWA
INSTRUCTION MANUAL
EU
KOWA VX-10a
INTRODUCTION
This manual provides a description of the operating procedures of KOWA along with important
precautions to be observed during its use. Please read this entire manual carefully to assure that the instrument
can demonstrate its full capabilities and be used effectively. After you have finished reading it, please keep it in an
INTRODUCTION
easily accessible location near the instrument for future's reference.
■ Meanings of markings
Warning
If the instrument should be operated wrongly, there may occur a danger of causing death or serious injury.
Caution
If the instrument should be operated wrongly, there may result an injury to the human body (not so serious as to
cause death though)*1 or damage to property*2.
*1: An injury to the human body means any injury, burn, electrical shock and so forth that will not necessitate
hospitalization or long-term outpatient treatment.
*2: Damage to property means an extensive damage to the house and household goods as well as the 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 associated 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 it's associated message on or near a pictorial symbol.
Graphical indication of mandatory action (obligatory item). What must always done is explicitly
and pictorially indicated by a picture or it's associated message on or near a pictorial symbol.
• 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 the instruction manual.
• Any damage resulting from, for instance, malfunctioning of the instrument caused by a combination of
connected devices.
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INTRODUCTION
Warning
If any abnormal smell or sound, or overheating or smoke should be detected, be sure to turn OFF
power supply immediately and then unplug it from the power outlet. If it should continue in use, a fire
may break out on the instrument resulting in its malfunctioning.
Unplug
Contact your Kowa dealer where you purchased it or your nearest repair shop for inspection.
When replacing the flash tube or observation light bulb, be sure to turn OFF the
INTRODUCTION
main power switch and unplug it from the power outlet, and wait for 30 minutes or
Warning more. Otherwise, there may occur electrical shock.
Unplug High-voltage
When replacing the fuse, be sure to turn OFF the main switch and unplug it from
the power outlet.
Warning If the fuse holder cover is removed with the instrument unplugged, there may
Unplug High-voltage occur electrical shock.
Be sure to properly plug the plug or AC adapter into the power outlet.
Otherwise, there may occur a fire or electrical shock.
Obligatory
Make sure that the instrument is properly grounded to protect the human body. Put the plug in the
three-wire grounding socket. Otherwise, there may occur electrical shock.
Obligatory
Do not disassemble, modify or repair the instrument yourself. Otherwise, there may occur a fire,
electrical shock, instrument malfunctioning or the human body may be injured.
Disassembly Contact your Kowa dealer where you purchased the instrument for repair. The product assembled
prohibited by yourself will not get warranty or any other service.
The socket or plug board must not be loaded in excess of its rated capacity.
If the main power cable should share an outlet with many other devices, there may occur a fire or
Prohibitory you may get an electrical shock.
Insertion of any metallic object in air vent slots may cause electrical shock resulting in malfunction,
fire or electrical shock.
Prohibitory
Be sure to use accessory batteries. When replacing them because of their having been in use longer
than a specified useful life, be sure to use specified ones. Because the battery contains flammable
substance such as lithium and organic solvent, there may occur heat build-up, burst or fire.
1. Be sure to observe the following:
• Do not charge, short-circuit, disassemble, deform, heat or put into fire, the battery.
• Do not connect the battery’s (+) and (–) poles by wire. Do not carry or store it closely together
with metal necklace or the like.
• Properly wire either of the battery’s (+) and (–) poles.
Obligatory
• Do not combine new batteries and used or any other types of batteries when in use.
• Do not solder a wire directly on the battery.
2. Before discarding used batteries, apply adhesive tape around their terminals for insulation. If
they jumble up with other metallic objects or batteries, there may result heat build-up, burst or
fire.
3. Be sure to keep batteries off children.
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INTRODUCTION
Caution
Pull off the plug from the power outlet without giving a pull.
Prohibitory
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Prohibitory
Do not install the power unit at unstable locations, for instance, on a shaky base or a tilting surface.
Otherwise, if it should drop off or fall over, the human body may be injured.
Prohibitory
Do not replace flash tube and the observation light bulb immediately after its
service.
Warning Otherwise, you may burn your fingers on the hot tube or lamp. Allow 30 minutes or
Prohibitory High-temperature so of cool-off before replacing.
When replacing the camera back, firmly hold by hand and fix it. Otherwise, it may drop off resulting
in a bodily injury.
Obligatory
The power supply must be provided for the sole use of this fundus camera. Sharing one and the
same power supply with other devices may cause a malfunction.
Obligatory
• This camera back uses two lithium batteries CR123A. Be sure to use appropriate batteries.
• Remove the batteries when the camera is expected to be kept unused for a long period of time.
Obligatory • Store batteries in a dry and cool place with no direct sunlight.
When moving up or down the chin-rest to adjust the height of the patient’s eyes, carefully manipulate
the camera while checking the position of the patients’ head. A patient with the smaller head may
Obligatory get his or her head caught between the device components.
The air vent must not be obstructed. Such obstruction will cause internal temperature to increase
resulting in occurrences of breakdown, malfunction or a fire.
Prohibitory
When batteries are stored, they must not be exposed to direct sunlight, high temperature or high
humidity.
Prohibitory
Keep your fingers off the spaces between sliding base and base’s power housing when operating
the control lever.
Prohibitory There is a fear of your fingers being caught and injured when the sliding base moves.
Keep your hand off the space between the main camera unit and the horizontal arm when tilting the
camera.
Prohibitory There is a fear of your fingers being caught and injured when the main camera unit is tilted.
Keep your fingers off the space between the tilt arm and its sliding area.
There is a fear of your fingers being caught and injured when the tilt's sliding area is moving.
Prohibitory
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Caution
Keep your fingers off the gap between the base’s power housing and the poles of chin-rest unit.
Therefore, instruct the patient not to hold the poles by hand because there is a fear of your fingers
Prohibitory being caught and injured.
Keep your fingers off the gap between the base’s power housing and the horizontal arm.
There is a fear of your fingers being caught and injured. When the horizontal arm is lowered or the
INTRODUCTION
Be careful about the distance between the objective lens and patient's face.
There is a fear that the end of objective lens may get in touch with the patient’s face (eye, nose, so
Prohibitory forth) and injure it when you bring the camera close to the patient.
Keep your fingers off the space between the ocular and the 35-mm camera back when adjusting
diopter.
Prohibitory There is a fear of your fingers being caught and injured when you rotate the eyepiece.
Do not wipe the exterior of the instrument with solvent such as benzene, alcohol, thinner and ether.
Doing so may cause discoloration or degradation.
Prohibitory
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INTRODUCTION
A A Air vent
D F
C
A G
Air vent
C
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A B E
D
D Air vent
A A Air vent A
A Air vent
Caution
A. Keep your fingers off the spaces between the sliding base and the base’s power housing when
operating the control lever.
Caution There is a fear of your fingers being caught and injured when the sliding base moves.
B. Keep your hand off the space between the main camera unit and the horizontal arm when tilting
the camera.
Caution There is a fear of your fingers being caught and injured when the main camera unit is tilted.
C. Keep your fingers off the space between the tilt arm and its sliding area.
There is a fear of your fingers being caught and injured when the tilt's sliding area is moving.
Caution
D. Keep your fingers off the gap between the base’s power housing and the poles of chin-rest unit.
Therefore, instruct the patient not to hold the poles by hand because there is a fear of your fingers
Caution being caught and injured.
E. Keep your fingers off the gap between the base’s power housing and the horizontal arm.
There is a fear of your fingers being caught and injured when the horizontal arm is lowered or the
Caution sliding base is moving.
F. Be careful about the distance between the objective lens and patient’s face. There is a fear that
the end of objective lens gets in touch with the patient’s face (eye, nose, so forth) and injures it when
Caution you bring the camera close to the patient.
G. Keep your fingers off the space between the optical viewfinder and the 35-mm camera back when
adjusting diopter.
Caution There is a fear of your fingers being caught and injured when you rotate the eyepiece.
Insertion of any metallic object in air vent slots may cause electrical shock resulting in malfunction,
fire or electrical shock.
Caution
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INTRODUCTION
Emblem list
Warning,Caution :
Type B applied part
See APPENDIX
Warning High-voltage
Alternative Current
(See P7-3,P7-4)
Caution High-temperature
OFF
(See P7-3,P7-4)
Symbol for
ON
"MANUFACTURER"
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INTRODUCTION
Precautions in operation
● Only qualified personnel should operate this equip- ● Do not turn ON/OFF the main switch in succession.
ment. There should be an interval of 5 seconds or more.
● When handling the fundus camera, pay special ● When plugging or unplugging, turn OFF the main
attention not to give strong shock to it. switch beforehand.
● Install and store the instrument in a place free from ● Do not change the camera back with the main switch
high temperature and humidity, direct sunlight, and ON.
INTRODUCTION
avoid the dusty place. Strictly observe the following en- ● The power line from the power outlet must be exclu-
vironmental conditions: sively connected to the fundus camera.
In operation In Transportation, storage
Precautions on the main camera unit and
Environmental Temperature 10 to 35°C -15 to +55°C
relative systems
Relative Humidity 30 to 90% 10 to 95% ● If any stain, smear or scratch should exist on objective
● When in use, in storage or in transit, care must be used lens, it will appear as a white spot on pictures taken.
to keep the instrument from dewing. Therefore, it is essential to always keep the lens sur-
● Place this fundus camera in room, the luminance of face clean.
which can be lowered as low as about 5 lx (the lumi- ● Do not leave the camera mount open without camera
nance as low as you can scarcely read newspaper). back mounted. In case the camera is expected to be
● To keep the instrument dust-free, use the cover sup- not used for a long period of time, be sure to seal the
plied with it when the camera is not in use. mount with the accessory cap.
● Protect the optical viewfinder barrel and eyepiece tube
Precautions on electric system from strong shocks or forceful pressures.
● In case the KOWA should be used after a ● Set a dial or knob with click(s) to its proper click index.
long ‘unused’ period of time, inspect and check the fol- ● If picture angle selector, filters in the observation light
lowing before starting it: system or dioptric lens for compensating the examined
• The objective lens is neither dusty nor stained. eye should be incorrectly set, pictures taken will result
• The observation light's intensity has not changed. in failures such as vignetting, under-exposure, and so
• The battery (for instance, camera battery) the level of forth.
which stays within service range. ● Securely fix the camera back on the camera mount by
its lever. If not, pictures taken will result in failures such
● Connect the camera with the power outlet properly so
that the plug might not be pulled out accidentally. as displaced or out-of-focus images. At worst, the cam-
But if it should occur, be sure to turn OFF the main era back may drop off and damaged and as a result,
switch before connecting the plug again. you will be obliged to suspend photography.
● If irregularity should occur in the circuit in the power ● Because the main camera unit and camera back are
unit, for instance, when you plug in with the main composed of precision parts, special tools will be
switch ON, “Err 1” will appear on the display and pho- needed for adjustment. Do not attempt to disassemble
tographing will be disabled. In this case, turn OFF the or adjust them by yourself.
main switch and wait for a while. Then turn it ON. If
“Err 1”does not appear on the display, you may resume Disposal Precautions
photography. ● LCD display of this instrument has a fluorescent
● Kowa is not responsible for any failure(s) or damage(s) lamp that contains mercury. When disposing this
caused by improvement, repair or maintenance ren- instrument, applicable federal, state, and local
dered by the third party other than Kowa and its autho- regulations must be observed.
● When disposing, this instrument is categorized
rized agent.
as industrial waste; therefore, the disposal must
● Kowa is not responsible for any failure(s) or damage(s)
be handled by licensed industrial waste disposal
caused by improvement, repair, or maintenance contractor.
rendered using the part(s) other than its designated
one(s).
● The line voltage should be within ±10% of the rated
value.
● Never change the electronic flash intensity when it’s
flashing is on.
● To operate switches on the control panel, first turn ON
the main switch and then wait for about 10 seconds
(until the power unit becomes internally stable).
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INTRODUCTION
(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) Equipment 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) Make sure that all batteries are installed properly and in good working order (discharging curve, polarity, and so forth).
(7) Properly connect ground wires.
3. The following items shall be considered when using the instrument.
(1) Make sure that equipment 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.
(6) Before operations, make sure that the camera back battery is sufficiently charged.
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 equipment and patient are in good condition.
(3) When an abnormality is found on the equipment, 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 statuses 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.
(a) Store the instrument at locations free from splashes of water.
(b) 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.
(c) Take care to guard against tilt, vibration and strong impacts, for instance, during transportation.
(d) Equipment must not be stored at locations where chemicals are stored or gasses are generated.
(4) Clean and rearrange accessories, cords, cord restraints 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 it is expected to be not used for a long period of time, keep the camera back with batteries unloaded from it.
6. If it has some trouble, a label describing the trouble should be affixed on the instrument and contact a repair
shop for repair.
7. Equipment shall not be modified.
8. Maintenance
(1) Periodically check the equipment and its components for any abnormality.
(2) When using again the equipment that has not been used for a while, it must be checked beforehand to assure that it is
in normal condition and operates safely.
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INTRODUCTION
INTRODUCTION
ENVIRONMENT ENVIRONMENT
1a Items A and B in A B
PATIENT ENVIRONMENT IEC IEC
60601 60601
A
1c Item A powerd from IEC 60601 For B:Additional
specified power supply in
item B in PATIENT ENVI-
B protective earth or
IEC XXXXX separating transformer
RONMENT
A B
2b Item A in PATIENT EN- IEC IEC For B:See 19.201
VIRONMENT and item B 60601 XXXXX and its rationale
in medically used room
Common protective earth
3a Item A in PATIENT
ENVIRONMENT and item A B For B:See 19.201
B in non-medically used
IEC IEC 60601 and its rationale
room 60601 or IEC XXXXX
3
A B
3b Item A in PATIENT
IEC IEC 60601 For B:Additional
ENVIRONMENT and item
B in non-medically used
60601 or IEC XXXXX protective earth or
SEPARATION DEVICE
room Protective earth Protective earth with po-
tential diffence
KEY TO TABLE
• Additional protective earth : In 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 [IEC 60989]
• SEPARATION DEVICE : If necessary, apply SEPARATION DEVICE.
• IEC 60601 : MEDICAL ELECTRICAL EQUIPMENT in compliance with IEC 60601.
• IEC XXXXX : Non medical equipment in compliance with relevant IEC safety standards.
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INTRODUCTION
● 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”, one of the system components.
● Prerequisite for installing other components (a PC, printer, video capture printer, video monitor, or other devices) which
INTRODUCTION
do not comply with IEC60601-1 along with this system is that the electric power to the components is supplied from
“Multi-tap with Isolation Transformer”. The electric power to these components supplied from an electric source other
than Multi-tap with Isolation Transformer (e.g., directly from wall outlets) may cause increased enclosure leakage current
or potential difference between protective grounds, resulting in the injury to the patient or operator. Please use the Multi-
tap with Isolation Transformer only for supplying the power to the components other than the system components.
● Any medical electrical equipment that is connected to this system to compose a medical system must comply with
IEC60601-1.
● 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.
● Do not use any additional multi-tap receptacle or extension power cable other than those specified to this system by
KOWA.
● 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 receptacle to the system or “Multi-tap with Isolation Transformer”.)
● The power cable for an electrical device that compose a medical system must have durability that meets IEC60245/
IEC60227 or higher standards.
● Assure that the power supply is turned off when connecting an electrical device to the system.
● Do not turn on the power supply until all devices are completely connected.
● Do not place or install the devices and the system components on the unstable or inclined table.
● 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.
● The power supply cable to “Multi-tap with Isolation Transformer” must be connected to a power receptacle with a
protective ground terminal.
● When using “Multi-tap with Isolation Transformer” with a protective ground terminal, read the instruction for use attached
to the “Multi-tap” receptacle to familiarize yourself with the correct use before using it.
1. System components
● Wipe the soiled outer surface with soft cloth from which water was firmly squeezed off. Do not wipe the exterior of
the system components with chemicals or solvents such as thinner and benzene. (Because LCD monitor screen
covers easily get scratched, lightly wipe with soft cloth such as gauze.)
● Refer to the instruction for use provided with each device for details of device maintenance and cleaning.
3. Others
● When you add a PC to the system for a filing purpose, captured images are stored in the hard disk drive of the PC.
Back up the data stored in the hard disk drive regularly since hard disk drives may have a mechanical or electrical
failure.
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INTRODUCTION
ACCESSORIES
INTRODUCTION
External fixation lamp:
Hexagon wrench:2 pcs. Pin: 2 pcs. Chin-rest paper: 1 set
1 pc.
Fuse: 2 pcs. Observation lamp: 1 pc. Blower: 1 pc. Detach tool: 1 pc.
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INTRODUCTION
INTRODUCTION
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INTRODUCTION
KOWA
Summary of equipment
INTRODUCTION
1
Preparatory procedure 2
Basic photography 3
Handy features 5
Troubleshooting 6
Daily inspection 7
Specifications 8
Technical references 9
Photochemical Hazard
(ISO 15004) 10
Electromagnetic Compatibility
(IEC60601-1-2) 11
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INTRODUCTION.................................................................................................................... P0-1
Operational considerations for safety..................................................................................... P0-1
Indication of caution label....................................................................................................... P0-6
Precautions in operation......................................................................................................... P0-7
1 Operational (Safety and Hazard prevention)
Considerations for hospital Grade Electrical Equipment........................................................ P0-8
Precautions: Use of Medical Electrical System.................................................................... P0-10
2 ACCESSORIES....................................................................................................................P0-11
P0-14
1-1 Purpose of use and effectiveness
KOWA is intended for taking pictures of fundus images with mydriatic or without mydriatic.
Summary of equipment
1-3 Features
1) A single operation of the instrument allows you to select non-mydriatic color, mydriatic color, or mydriatic
fluorescent photography.
2) Design for small size, lightweight and power-saving taking into account the service environment of equipment.
3) Automatic exposure system which can be automatically linked with a camera in use.
4) Wide-range flash of 0.6WS to 300 WS (19 steps) for fully handling film/digital image recordings.
5) Switch at hand which enables automatic insertion of exciter filter and barrier filter.
6) Switch at hand which enables switching to diopter lens for compensating the examined eye.
7) Working distance guiding function and focus detecting function, enabling flare-less, sharp pictures to be taken.
8) Small pupil mode to cope with insufficient pupil’s diameter in mydriatic photography (not for non-mydriatic pho-
tography).
9) LCDmonitoring mode for readily enabling mydriatic photography without an attempt to look through a finder
(switch to infrared illumination).
10) Digital camera can be connected if combined with a filing device.
11) Easy-to-see panel display which will indicate only available switches in each mode.
P1-1
1. Summary of equipment
E
5
6
1 2 1
F
Summary of equipment
H J
7
K
G
4
9 8
3 I
0
A
BC D
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1. Summary of equipment
Summary of equipment
D Power cord L Picture angle knob
The shape of the plug varies according to the Used to select a picture angle of either 50° or
input voltage. 30° (45° or 27° for non- mydriatic photography).
E External eye fixation lamp M Data card slot
Used to guide the examined eye's fixation to An insertion slot for written data card to be in-
desired direction. serted.
F Forehead-rest N Filter inserting slot
Used to rest and fix the patient's forehead Used for inserting optional green filter after re-
against it. moving the protective rubber cap.
G Chin-rest O Light housing cover fixing screws
Used to rest and fix the patient's chin on it. Upon removal of this cover and inner cover,
H Head fixation band observation bulb and flash bulb will be exposed
Used to secure patient's head in case his or her allowing replacement.
face is likely to move (e.g. child patient). Be sure to turn off the power switch before re-
I Chin-rest handle placement.
Used to raise/lower the chin-rest. P Liquid crystal monitor (LCD)
J Eye level mark In non-mydriatic mode,the examined eye is con-
The vertical position of examined eye must be tinuously observed on this monitor so that the
aligned with this mark. fundus camera can be properly guided.
K Fitting part of internal fixation target This monitor can also be used to check the im-
ages photographed.
Fit internal fixation target (optional) at its mount.
P1-3
1. Summary of equipment
1
Summary of equipment
P1-4
1. Summary of equipment
Summary of equipment
^ Non-mydriatic switch e S.P. switch
Used to switch the system to non-mydriatic Used to switch the system to small pupil pho-
color photography. tography in mydriatic fluorescein mode.
a Fluorescein Angiography filter switch f LCD monitoring switch
Used to insert or remove fluorescein filter in Used to switch the observation system from a
mydriatic fluorescein angiography mode. finder to LCD monitoring.
b Timer switch g Monitor select switch
Used to start or stop the timer in mydriatic fluo- Used to switch the images shown on the LCD
rescein mode. monitor between the internal CCD images and
c Diopter lens switch the images from an external input.
Used to insert diopter lens for compensating the h Blue Eye switch
examined eye. Used to adjust the intensity which is suitable for
Although the examined eye's bias is indicated blue eyes.
as plus (+), zero (0) or minus (-), it is not intend- i Anterior chamber select switch
ed to compensate flash intensity. Used to insert or remove dioptric lens for ante-
d Fixation lamp switch rior chamber observation.
Used to select a desired type of fixation lamp in
non-mydriatic mode.
P1-5
Make sure the power is OFF.
2-1 Installing
1) Assemble the fundus camera main camera unit and power unit/base in accor-
dance with a separate Assembly Manual.
2) Mount the fundus camera on motorized table (option).
3) Make sure that the power switch is OFF ( -marked side) on the power unit and
base.
4) Insert power cord’s three-wire grounding plug of the power unit/base into the
power outlet.
2
Caution
Preparatory
The power line from the power outlet must be exclusively connected to the fundus camera. If the
camera should share the same power outlet with any other external device, its malfunction may
Obligatory result.
Warning
Make sure that the instrument is properly grounded to protect the human body. Put the plug in
the three-wire grounding socket. Otherwise, there is a fear of electrical shock.
Obligatory
• When you use a peripheral device and/or other device connected to the peripheral device, it must meet all
applicable EN(IEC) standards.
• Data processing device must meet EN60601-1(IEC60601-1) or IEC60950. The system that combines such
data processing device must meet EN60601-1-1(IEC60601-1-1). 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.
P2-1
2. Preparatory procedure
1) Open the cover. 2) Load batteries. 3) Check for remaining charge level.
Preparatory
• A winding film without mounting to the main camera unit shortens a life of batteries.
• If film is wound being mounted the main camera unit, its useful life is one year and a half.
Caution
• This camera back uses two lithium batteries CR123A. Be sure to use proper ones.
• If the camera back is not expected to be used for a long period of time, keep the batteries
unloaded from it.
Obligatory • Store batteries in a place where they can be protected from direct sunlight, high temperature
and high humidity.
Warning
Be sure to use accessory batteries. When replacing them by the new because their use is in
excess of a specified useful life, be sure to use designated ones. Because the battery contains
flammable substance such as lithium and organic solvent, there may occur heat build-up, burst
or fire.
1. Be sure to observe the following:
• Do not charge, short-circuit, disassemble, deform, heat or put into fire the battery.
• Do not connect the battery’s (+) and (–) poles by wire. Do not carry or store it closely together
with metal necklace or the like.
Obligatory • Properly connect its (+) and (–) poles.
• Do not combine new batteries and used batteries or any other types of batteries when in use.
• Do not solder a wire directly onto the battery.
2. Before discarding the used batteries, apply adhesive tape around their terminals for insulation.
If they should jumble up with other metallic objects or batteries, heat build-up, burst or fire
may result.
3. Be sure to keep batteries off children.
P2-2
2. Preparatory procedure
2-5 Mounting 35-mm camera back 1) To mount/ turn the handle downward
1) Mount the camera back with the limit pin facing upward on the main camera
unit’s 35mm mount and fix it by turning the handle downward.
2) To dismount it, turn the handle upward.
Warning
When replacing the camera back, fix it while firmly holding it by
hand. Otherwise, it may drop off resulting in a bodily injury.
Obligatory
2
Preparatory
• The number on frame count display will disappear in four seconds for power
saving. You may check it by pressing the battery check button.
• If the rear cover should be opened with the exposed film unwound, the
exposed film will be ruined under light. Be sure to check the display of a film
count before opening the rear cover.
• If “Er” appears or “00” does not come off on the film count display, it suggests
that the film is incorrectly loaded. Follow the film loading procedure all over
5) The rewind button
again.
• When the film is exposed up to the last frame, an alarm sound will buzz and
rewinding will be done automatically.
P2-3
2. Preparatory procedure
Preparatory
• Do not use other than designated films to avoid improperly exposed photographs.
• When using mydriatic eye drops, be sure to follow the instruction of the eye drops.
P2-4
2. Preparatory procedure
Warning
Carefully operate the fundus camera so that the camera will not get in touch with the patient’s
face (eye, nose, so forth).
Prohibitory
Caution
In operating the fundus camera, keep your fingers off the spaces or gaps between (1) the base
and power unit, (2) the main camera unit and horizontal arm, (3) tilt arm and tilt moving portion,
(4) the power unit and chin-rest support, (5) the power unit and horizontal arm, and (6) the objec-
Prohibitory tive lens and the patient’s face. Otherwise, your fingers may be caught and injured. Instruct the
2 patient not to place his or her hand on the fundus camera.
Preparatory
Caution
Carefully adjust the height of the examined eye by moving the chin-rest vertically while looking at
the patient’s face. There is a fear that too small a face may be caught.
Obligatory
P2-5
3-1 Operation procedure flowchart
Select photographic optical path and check the number of unexposed frames.
Basic photography
Flash intensity compensation
Focusing adjustment
Timer start
Fluorescein injection
F.A.filter insertion
Photography
Photography by this instrument is classified into non-mydriatic/mydriatic color, mydriatic fluorescein photography. It
is recommendable to grasp a rough operations’ flow along the purpose of each photography. If malfunction should
occur on this equipment, an alarm will buzz.
Besides this classification of photography, also available are photography of enlarged image, small pupil, LCDmoni-
toring and infrared photography (when optional filter is mounted). It is also possible to record hand-written data into
35-mm film. For more information about the method, see items of “4 Other practical photography” described below.
Do not photograph immediately after switching to a desired mode to avoid an improper picture image. Therefore,
wait at least three seconds before starting photography.
P3-1
3. Basic photography
3-2
Non-mydriatic photography
P3-2
3-2. Non-mydriatic photography
FA Color
3-2
Blue
Eye
Non-mydriatic photography
Check the examined eye’s pupil for dilation and correct the flash intensity.
• If the pupil is insufficiently dilated, take longer time to acclimate the examined eye to darkness and let it
dilate spontaneously.
• If the pupil is still insufficiently dilated even by the above method, switch to mydriatic photography mode.
• The above conditions may not be applicable to some patients.
P3-3
3. Basic photography
FA Color
3-2
Non-mydriatic photography
Blue
Eye
8) Adjusting focus.
Adjust the positions of luminous lines for focusing detection by turning the focusing knob such that they are ar-
ranged in a straight line.
9) Press the Shutter button for photographing. The film will be advanced automatically.
In case of electronic images, images to be taken will be displayed on the monitor.
9) Shutter button
P3-4
3-2. Non-mydriatic photography
n Flash intensity.
n Flash intensity knob / display
Exposure can be automatically adjusted to have a standard intensity for each
photography. But it is expected that excess or deficiency in exposure caused
by the difference in dilation, color of iris, etc. will cause some deviation from
the standard state. In case excess or deficiency in exposure should be
expected, correct the exposure by the flash intensity knob. On the display on
the panel, a currently set value of exposure will be indicated as a standard. If
stage 1 is selected of the flash intensity compensation switch, the intensity of
exposure will change by 1/2 EV.
Non-mydriatic photography
n Working camera back indicator.
n Camera change-over indicat-
Operations of the indicating lamp show the following: ing lamp
P3-5
3. Basic photography
3-3
FA Color
Mydriatic color photography
Blue
Eye
3) Select a desired photography optical path by the camera back select switch on the left-hand panel.
4) Check the remaining film level in the back of the selected optical path.
In case of electronic images, check if the peripheral devices are ready.
5) Check the state of dilation.
Make sure that the pupil is sufficiently dilated. If not, see the paragraph “4-2 Small pupil photography ( “Mydriatic
color” and “FA” mode)”.
3) Selection of optical path 4) Check the film. 5) Check the state of dilation.
5.5 mm or less
“4.2 Small pupil photography”
P3-6
3-3. Mydriatic color photography
FA Color
3-3
When photographing
upward, direct the fixa-
tion lamp upward.
When photographing
downward, direct the
When When fixation lamp downward.
photographing photographing
the right eye the left eye
P3-7
3. Basic photography
11) Press the Shutter button to photograph. The film will be automatically advanced.
3-3 In case of electronic images, photographed images will be displayed on the monitor.
n How to guide the observation light to the examined eye in mydriatic photography.
In fundus photography, it is necessary to guide necessary exposure which comes to the fundus through the
pupil. Therefore, the camera position that will satisfy this lighting condition to the examined eye is very re-
stricted. Flashlight travels on the same path as observation light. So if you can observe the fundus under a
uniform illumination without flare and reflections (correct camera position for incidence), you are sure to get
good fundus photographs.
a) While looking into the cornea of the examined eye from the side of objective lens, move the base lon-
gitudinally and laterally with the control lever upright such that a rough image of illumination ring-slit
focused on the cornea of the examined eye can be obtained.
b) Adjust vertical positioning of the camera by turning the camera height adjusting ring.
c) Then while looking into the viewfinder, adjust alignment, guide the observation light into the fundus.
a) b) c)
P3-8
3-3. Mydriatic color photography
• Do not increase the amount of observation light and the amount of light for exposure more than required.
Otherwise, pain and/or injury may be inflicted on the patient.
• Be sure to use correct optical viewfinder diopter. If the diopter is incorrect, pictures will become out of focus.
P3-9
3. Basic photography
Items 2) through 10) are the same with those of “3-3 Mydriatic color photography.” For more information, see the
items of “3-3 Mydriatic color photography”.
1) Select mydriatic fluorescein by the mode select switch on the panel.
2) Adjust the optical viewfinder diopter.
3) Select a desired photography optical path by the camera select switch on the left-hand panel.
4) Check the remaining film level in the back of the selected optical path.
5) Check the diameter of pupil.
6) Compensate the examined eye’s diopter.
7) Adjust positioning of the examined eye.
8) Adjust the position of external fixation lamp.
9) Guide the patient’s line of sight.
10) Adjust the focusing.
3-4
Next, proceed to the procedure necessary for fluorescein angiography only.
A blue exciter filter is inserted automatically when “F.A.” is selected by the mode select switch in Step 1) above.
Mydriatic fluorescein angiography
FA Color FA Color
Blue Blue
Eye Eye
P3-10
3-4. Mydriatic fluorescein angiography
n Fluorescein angiography at the rate of one frame per second. n 1 frame per second photography
In case of consecutively photographing at an interval of 1 second, keep
pressing the shutter button.
But some backs may not support such photography.
Upon pressing mydriatic fluorescein select switch, the blue exciter filter
will be automatically inserted. But another method is that ,alternatively, 3-4
upon pressing mydriatic fluorescein select switch, the barrier filter can be FA Color
P3-11
4-1 Photography of enlarged image
4) Switching picture angle
This paragraph describes the method of photographing enlarged image. On this
equipment, you can select from the picture angles of 50° and 30° in mydriatic color
and mydriatic fluorescein modes, and from those of 45° and 27° in non-mydriatic
mode.
4
n Photography of enlarged image
Other practical photography
• Photograph by enlarging the central part to be photographed at the picture angles of 30° (27°) against those
of 50° (45°).
• In photographing enlarged image, guide the patient's line of sight such that the part to be photographed can
come in the center of the picture angles of 50° (45°).
• When luminous lines for focusing detection is
in use, adjust the focusing at the picture angles
of 50° (45°). You need not adjust focussing after
changing the picture angle.
• When video camera connecting adapter is in use, be sure to switch the picture angle knob at the same time
as well.
• When the picture angles of main camera unit and video adapter do not agree, pressing the shutter button
causes an alarm to sound and permits no image to be captured.
• It takes about 3 seconds to switch to Small pupil mode.
Since photographing immediately after switching the mode does not allow you to capture a good image, wait
at least three seconds before starting photography.
3) Adjust the focusing and alignment and then press the shutter button to
photograph.
P4-1
4. Other practical photography
• In case the small pupil mode is used, the picture angles of photography will be 45° and 27°.
• In case of the pupil the diameter of which is 4.0 mm or less in diameter, uniformly exposed images cannot 4
be photographed.
1) Select “Color” by the mode select switch on the right-hand panel. 2) Filter inserting slot
2) Insert the optional green filter into the slot on the side of the main
camera unit. Now the patient observation light turns green.
3) The subsequent procedure is the same as in the items of “3-3
Mydriatic color photography.” Proceed to photography following the
preceding paragraph.
n In red-free photography, red-less light is produced by absorbing red wavelength from light, and as a result,
good fundus pictures are obtained in which blood vessels have a high contrast with the retina.
In these types of photography, roll of ISO400 B&W negative film (3-times-development) or of B&W ISO1600
film (standard development) is recommended.
P4-2
4. Other practical photography
essary.
Blue
Eye
P4-3
5-1 LCD monitoring mode (“Mydriatic color” and “FA” mode)
This paragraph describes the method of performing mydriatic photography watching LCD monitor instead of looking
into viewfinder as if doing non-mydriatic photography. This feature allows you to photograph without diopter adjust-
ment. Also a patient becomes free from dazzling observation light since it uses infrared light in the mydriatic color
mode and reduces the intensity of observation light in the mydriatic fluorescein mode. Therefore you can photo-
graph smoothly.
1) Select “Color” by the mode select switch on the right-hand panel. 2) LCD monitoring switch
2) Press “LCD monitoring” switch on the right-hand panel.
The LCD monitor will start with operating sound while the observation light turns
infrared light.
3) From now on, operate according to the paragraph of “3-2 Non-mydriatic
photography.”
Starting with the item 2), you can photograph as if doing non-mydriatic
photography.
In LCD monitoring mode, you can perform non-mydriatic photographing at a picture angle of 50° of the ex-
n
amined eye the pupil of which can be spontaneously dilated to 5.5 mm or so in diameter, without applying
5
mydriatic eye drops to it.(non-mydriatic photography at a picture angle of 50°.)
Handy features
In mydriatic color mode, observe and set the examined eye with infrared light as in the case of non-mydriatic
n
photography. Thus, because the patient can be free from dazzling observation light, you can smoothly per-
form photography for the patient even if not accustomed to dilating the pupil.
Non-mydriatic photography
at a picture angle of 50° will
be enabled if the pupil can be
spontaneously dilated to 5.5
mm or more in diameter
• Unlike observation through viewfinder, accurate states of flare and focusing will become hard to check for.
• When observing on LCD monitor, bear in mind that, unlike an actual picture image taken, both a fluorescein
angiogram and a normal fundus picture image will appear on the monitor. (Picture image taken will be
limited to fluorescein angiogram.)
P5-1
5. Handy features
5 unit is displayed.
Handy features
n The default setting is switched between Automatic and Manual. For details see “5-3 Changing default
setting”. Monitor select switch may be disabled. By disabling the switch, you can prevent a malfunction
when no external imaging device is used. Refer to “5-3 Changing initial settings” for details.
When you use the external image display mode, make sure to use an external imaging device with a video
n
output and connect it to the video input of this unit. Please note that no image is shown on the fundus cam-
era monitor when the external image display mode is selected.
P5-2
5. Handy features
SW Description OFF ON
Handy features
SW 9 Don't use Don't use Don't use
Position of switch
P5-3
This paragraph describes remedies for any irregularity occurring on this equipment. If any irregularity should occur
on this equipment, check the following before contacting your Kowa dealer where you purchased it.
P6-1
6. Troubleshooting
Mydriatic color or mydriatic fluorescein See “7-5 Replacing with new fuse.”
mode selected. Switch to non-mydriatic mode.
Nothing seen when looking LCD monitoring mode selected. Cancel the LCD monitoring mode.
into viewfinder.
Picture angle knob wrongly positioned Align the picture angle knob with a posi-
and fixed. tion of 50°.
Luminous lines for focusing Turn off Anterior chamber select switch.
detection/luminous spots Is Anterior chamber select switch on? When Anterior chamber select switch is
for aligning the position de- on, detecting luminous dots turns off.
tection does not appear.
Switch “Anterior chamber select” switch
to OFF.
Diopter lens inserted. When inserting dioptic lens, the lumi-
nous line for focusing detection will
come OFF.
Troubleshooting
Timer’s counting does not OFF selected in initial setting of “timer’s Set it to ON.
sound. counting sound in operation.” See “5-3 Changing initial settings.”
P6-2
6. Troubleshooting
Objective lens fouled with, for instance, Clean the objective lens.
tears rolling down from the examined See “7-2 Inspecting/cleaning the objec-
eye. tive lens.”
Examined eye partly covered with its Keep the examine eye’s eyelashes from
eyelashes. optically interfering with its pupil.
Whitening around
peripheral of picture
6
Locally darkening on
Troubleshooting
picture
P6-3
Since the fundus camera is a precision instrument, it is necessary to carry out daily inspection and maintenance.
To keep your KOWA in good and safe conditions, please read this paragraph carefully.
4) If you intend not to use the camera for a long period of time, unplug from the 1) Seal the objective lens with cap
power outlet for safety’s sake.
• If the fundus camera in a cool room should be suddenly moved to a warmer room, or if the room in which
7
the camera is located should be suddenly heated, the objective lens and/or internal lens may be prohibitively
Daily inspection
fogged. Wait for a while until the lens is defogged, and after defogging, start photography. Otherwise,
pictures taken may become out of focus.
• If it has been repeatedly fogged, the lens may get moldy. In this case, contact our company or Kowa dealer
where you purchased it.
Caution
Do not wipe the outer surface of the instrument with solvents
such as benzene, alcohol, thinner, ether and the like. Other-
wise, such substances may cause the surface to be discolored
Prohibitory
or deteriorated.
P7-1
7. Daily inspection
3) Blow off by the accessory blower 4) Wipe the surface of the lens
n For cleaning all over again, discard the used lens cleaning paper (or gauze) and use the fresh one
moistened with the mixture, for complete cleaning.
• If it should be wiped with dust staying still on it or with force being applied on it, the lens may get scars on its
7 surface.
• Never use chamois skin or silicone-treated cloth.
• Because the suggested cleaning solution is highly volatile and flammable, special attention must be paid to
Daily inspection
P7-2
7. Daily inspection
1) Turn OFF the power switch before unplugging from the power outlet.
2) Loosen the lamp cover’s screws by coin or flathead screwdriver for
removal.
Make sure the lamp has been sufficiently cooled off before proceeding
to the subsequent steps.
3) For removal, loosen the inner black lamp cover’s screws by coin or
flathead screwdriver .
4) Remove the observation lamp from its socket as it is fitted while
3) Remove the inner cover
holding the lampshade by hand.
5) Press down a new observation lamp deeply into the socket to fit it
securely, with its shade being held by hand, while you must be careful
about the direction in which the shade’s protrusions are facing. Make
sure that the protrusion is securely fitted into the groove.
6) Tighten the inner black lamp cover’s screws again to fit it.
7) Fit the lamp cover and tighten the lamp cover’s fitting screws.
• Remove the observation lamp straight from the direction of the three pins located at its the base. Fit the new 7
lamp in the socket without applying any twisting force.
Daily inspection
• Press down the observation lamp deep into the socket to fit it securely.
• Fit the lamp cover while taking care that excessive stress will not be exerted upon the socket’s cord.
• Securely fit the shade’s protrusion into the groove to keep the lamp from giving uneven illumination during
observation.
• Do not touch the lamp in the shade with your bare hands. Otherwise, lamp’s useful life will be made shorter
due to burning of finger’s fat on hot lamp surface.
Warning Caution
P7-3
7. Daily inspection
7-4 Disinfect
Wipe the forehead-rest and the grip(option) 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.
• Remove the flash lamp straight from the direction of the three pins located at its base and then fit a new one
in the socket.
• Do not apply any twisting force.
7 • Press down the flash lamp deep into the socket and fit it securely.
• When installing the lamp cover, do not exert stress on the cord of the flash lamp socket.
• Do not touch the flash lamp with your bare hands. Otherwise, lamp’s useful life will be made shorter due to
Daily inspection
Warning Caution
P7-4
7. Daily inspection
Warning
When replacing with new fuses, turn OFF the power switch and
unplug from the power outlet. Otherwise, there is a fear of elec-
trical shock.
Use accessory or designated fuses. If other than designated
Unplug
ones should be used, there may occur failure or a fire on the
equipment.
The fuse differs according to the voltage which is used. Make sure Observation lamp K9L52 A26
to use a correct fuse when replacing one. 7
Data card K9L33#225
Daily inspection
Fuse×2 0218005.MXP
P7-5
Mydriatic 50° / 30°
• Picture angle
Non-mydriatic 45° / 27°
• Working distance 39 mm (from examined eye to front of objective lens)
0 – 12D ~ + 13D
• Range of Compensation of – –10D ~ – 32D
examined eye + +10D ~ + 35D
• Focusing Agreement of split luminous lines (with ON/OFF function)
• Working distance adjustment Luminous spot indication (with ON/OFF function)
• Range of dioptric correction –8D ~ + 5D
of optical viewfinder
• Observation light source Halogen lamp
• Electronic flash source Xenon flash lamp
(coarse motion) 90mm
Forward/backward (slightmotion) about 22mm
• Base vertical working range
(coarsemotion) 140mm
leftward/rightward (slightmotion) about 22mm
• Base vertical working range 30mm
Compliance standard
• EN 60601-1:1990 + A1:1993 + A2:1995 + A13:1996
• EN 60601-1-1:2001(IEC 60601-1-1:2000)
• EN 60601-1-2:2001 + A1:2006(IEC 60601-1-2:2001 + A1:2004)
Complied EC Directive
P8-1
Summary of synchronous connector Pin No. Signal
Connector in service: D-SUB 9-pin type 1 TIMER START
Engagement: M3
2 GND
3 GND
4 TRIG–IN(STOROBE)
5 GND
6 TRIG–OUT(TRIG)
7 NC
8 NC
9 NC
Caution
If you intend to use external synchronization connector, please contact Kowa
distributer.
5 Don’t use
Mydriatic fluorescein angiography select switch can op-
erate
6 ON: Barrier filter insertion
OFF: Exciter filter insertion 9
7 Don’t use
Technical references
8 Don’t use
9 Don’t use
10 Don’t use
P9-1
The relative spectral output of the instrument
0.5
Energy( J) for image capturing light
Illumination Light
0.4
0.35
0.3
0.25
0.2
0.15
0.1
0.05
0
300 400 500 600 700 800 900 1000 1100
Wavelength (nm)
(informative)
Spectrally weighted photochemical radiances LB and LA give a measure of the potential that exists of a beam of
light to cause photochemical hazard to the retina. LB gives the measure for eyes in which the crystalline lens is in
place. LA gives this measure either for eyes in which the crystalline lens has been removed (aphakes) and has not
been replaced by a UV-blocking lens or for the eyes of very young children.
The value stated for this ophthalmic instrument gives a measure of hazard potential when the instrument is oper-
ated at maximum intensity and maximum aperture. Values of LB or LA over 80mW/(cm2 • sr) are considered high for
beams which wholly fill a dilated pupil.
The retinal exposure dose for a photochemical hazard is a product of the radiance and the exposure time. For in-
stance, at a radiance level of 80mW/(cm2 • sr), 3 min irradiation of the dilated (8mm diameter) pupil would cause
the retinal exposure dose level to attain the recommended exposure limit. If the value of radiance were reduced to
40mW/(cm2 • sr), twice that time (i.e.6min) would be needed to reach the recommended limit. The recommended
exposure dose is based on calculations arising from the American Conference of Governmental Industrial Hygien-
ists (ACGIH) - Threshold Limit Values for Chemical Substances and Physical Agents (1995-1996 edition).
While no acute optical radiation hazards have been identified for ophthalmic instruments, it is recommended that
the intensity of light directed into the examined eye be limited to the minimum level which is necessary for diagno-
10
sis.Infants, aphakes and persons with diseased eyes will be at greater risk. The risk may also be increased if thep-
erson being examined has had any exposure with the same instrument or any other ophthalmic instrument using
avisible light source during the previous 24 h. This will apply particularly if the eye has been exposed to retinal pho-
tography.
Should you have any question (e.g., ratio of the variable intensity to the maximum intensity), contact us or your
Kowa dealer.
P10-1
KOWA is a medical electrical instrument. The medical electrical instrument requires special care concern-
ing electromagnetic compatibility (EMC). This section describes its suitability in terms of electromagnetic compatibil-
ity of this instrument. When installing or using this instrument, please read carefully and observe what is described
here.
(This instrument was tested on electromagnetic compatibility (EMC) based on IEC60601-1-2.)
1. Carefully handle portable- or mobile-type radio frequency communication unit (RF communications equip-
ment) since it may have an adverse effect on this instrument resulting in malfunctioning.
2. This instrument was tested on electromagnetic compatibility (EMC) with optional or accessory parts being
assembled into it.
Do not assemble into this instrument any optional or accessory parts other than those designated by
Kowa. Otherwise, this instrument may be adversely affected by other instrument resulting in malfunction-
ing, or the latter itself may malfunction.
• Power cable (a maximum length of 3 m)
• Video Adapters made by Kowa
• Dedicated synchronous cables (a maximum length of 5m),see P9-1
• Cameras with CE marking
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 con-
stantly monitor if the instrument is functioning normally after such use has been adopted.
4. We specified the functions listed in the table below as the essential performance of this instrument to
determine electromagnetic compatibility(EMC) of this instrument.
Functions Essential performance
Electromagnetic Compatibility
Flash lamp luminescence
Light-emitting functions Flash lamp intensity switching
Illumination light intensity switching
11
P11-1
11. Electromagnetic Compatibility (IEC60601-1-2)
RF emissions Group 1 The KOWA uses RF energy only for its internal function. Therefore,
its RF emissions are very low and are not likely to cause any interference in
CISPR 11 nearby electronic equipment.
RF emissions Class A
CISPR 11
Harmonic emissions The KOWA is suitable for use in all establishments other than do-
Class A
IEC 61000-3-2 mestic and those directly connected to the public low-voltage power supply net-
work that supplies buildings used for domestic purposes.
Voltage fluctuations/
flicker emissions Complies
IEC 61000-3-3
Electromagnetic Compatibility
(IEC60601-1-2)
11
P11-2
11. Electromagnetic Compatibility (IEC60601-1-2)
The KOWA is intended for use in the electromagnetic environment specified below.
The customer or the user of the KOWA should assure that it is used in such an environment.
Electromagnetic Compatibility
interruptions and (60% dip in U T ) (60% dip in U T
ment. If the user of the KOWA
voltage variations for 5 cycles for 5 cycles
requires continued operation during power
on power supply
mains interruptions, it is recommended
input lines 70% U T 70% U T
that the KOWA be powered
IEC61000-4-11 (30% dip in U T ) (30% dip in U T )
from an uninterruptible power supply or a
for 25 cycles for 25 cycles
battery.
<5% U T <5% U T
(>95% dip in U T ) (>95% dip in U T )
for 5 sec for 5 sec
Power frequency 3 A/m 3A/m Power frequency magnetic fields should
(50/60Hz) be at levels characteristic of a typical lo-
magnetic field cation in a typical commercial or hospital
IEC61000-4-8 environment.
NOTE U T is the a.c. mains voltage prior to application of the test level.
(IEC60601-1-2)
11
P11-3
11. Electromagnetic Compatibility (IEC60601-1-2)
The KOWA is intended for use in the electromagnetic environment specified below.
The customer or the user of the KOWA should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment– guidance
Portable and mobile RF communications equip-
ment should be used no closer to any part of the
KOWA , including cables, than the rec-
ommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
normal operation. If abnormal performance is observed, additional measures may be necessary, such as reori-
enting or relocating the KOWA .
b Over the frequency range 150kHz to 80MHz, field strengths should be less than 3 V/m.
11
P11-4
11. Electromagnetic Compatibility (IEC60601-1-2)
Electromagnetic Compatibility
(IEC60601-1-2)
11
P11-5
11. Electromagnetic Compatibility (IEC60601-1-2)
For EU market.
Electromagnetic Compatibility
(IEC60601-1-2)
11
P11-6
11. Electromagnetic Compatibility (IEC60601-1-2)
Electromagnetic Compatibility
(IEC60601-1-2)
11
P11-7
MEMO
(World Sales Headquarters)
4-14, Nihonbashi-honcho 3-chome, Chuo-ku, Tokyo 103-8433 Japan Immermannstrasse 43B
Phone : 81(3) 5623-8059 40210 Duesseldorf, F.R. Germany
Facsimile : 81(3) 5623-8060 Phone : 49(211) 1793540
Facsimile : 49(211) 161952
Hamamatsu Factory
3-1, Shinmiyakoda 1-chome, Kita-ku, Hamamatsu city, Shizuoka Pref., 431-2103 Japan
© 2009 Kowa Company, Ltd. All rights reserved.
K9L48B V1.0 E 090130 MS
Printed on recycled paper. Printed in Japan