Kowa KT 800 Instruction Manuel
Kowa KT 800 Instruction Manuel
Kowa KT 800 Instruction Manuel
INSTRUCTION MANUAL
INTRODUCTION
Accept our congratulations on your purchase of KOWA KT– 800.
This manual provides a description of the operating procedures of KT– 800 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 easily accessible location near the instrument for future's reference.
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.
1
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 fuse, be sure to turn OFF the main switch and unplug it from the power outlet.
If the fuse holder cover is removed with the instrument unplugged, there may occur electrical shock.
Warning
Unplug High-voltage
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 type socket. Otherwise, there may occur electrical shock.
Obligatory
Be sure that the tips of instrument are not in contact with the eye and the nose when in operation. (Otherwise,
the patient may likely be injured.)
Warning
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 by yourself
prohibited 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 cord should share a power outlet with many other devices, there may occur a fire or electrical
Prohibitory shock.
Caution
The power supply must be provided for the sole use of this instrument.
If it shares one and the same power supply with any external instrument, KT-800 may malfunction.
Obligatory
Pull off the plug from the power outlet without giving a pull.
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 wipe the exterior of the instrument with solvent such as benzene, alcohol, thinner and ether since such
substances may cause discoloration or degradation.
Prohibitory
If the instrument is intended to be not in use for a long period of time, unplug the power cable. Otherwise, a fire
may occur on it.
Unplug
Federal law restricts this device to sale by or on the order of a Physician or Practitioner for US market.
2
Location of Cautionary Marking
Before replacing fuse, be sure to turn the POWER switch OFF and
pull out the plug from the receptacle.
If you remove the cover of fuse without pulling out the plug, it
creates a risk of electrical shock.
Alternative Current
ON
OFF
3
Precautions Concerning Use
Precautions in operation • Do not turn the main switch on and off in succession.
Allow an interval of at least 4 seconds before turning
• When handling the Tonometer, pay special attention the main switch on and off.
not to give strong shock to it. • Make sure to turn the power switch off before inserting
• The instrument should be Installation, Transportation, or removing any plugs.
Storage in a dust free place free from high
temperatures, high humidity and direct sunlight. The Precautions concerning use of the main
environmental conditions described below should be unit
observed strictly.
• The non-contact tonometer used by this system is
In operation Transportation, storage designed for screening purposes. Measured values
may contain error depending on the particular
Environmental Temperature 10~40°C -15~+60°C
conditions of use. When measured values are
Relative Humidity 30~75% 10~95%
questionable, it is recommended to perform a more
• When in use, in storage or in transit, care must be precise examination using an applanation tonometer.
used to keep the instrument from dewing. • The printer used by this system produces the best
• Always cover the system when not use to protect its results when used within a temperature range of 10-
components. 40°C and humidity range of 30-75%. Please do not
use the paper in environments outside these ranges.
Precautions concerning use of the • Due to nature of the paper used, long-term storage
electrical system can cause it to deteriorate. When desiring to store
printed results for a long time, it is recommended to
• Install the system in a location where there is little risk
first copy them onto ordinary copier paper prior to
of the plug being pulled out. If the plug should happen
long-term storage.
to be pulled out, only plug it back in after first turning
• Perform the following inspections when resuming use
off the main switch.
of the system after not using for a long time.
• The manufacturer is not liable for malfunctions or
- Inspect soiling of the air nozzle surface.
injuries resulting from maintenance or repairs
- Inspect the inside of the air nozzle begin operations
performed by persons other than the specified repair
on controls and switches on the operation panel.
service.
- Setting of a date by menu mode.
• The manufacturer is not liable for malfunctions or
• Turn power switch off before unplugging or plugging
injuries resulting from modification, maintenance or
of power cord.
repairs using parts other than the specified repair
parts. Disposal Precautions
• The manufacturer is not liable for malfunctions or
• When disposing of this instrument, comply with the
injuries based on results obtained by not observing
regulations of countries or areas in which the
the cautions or operating procedure described in this
instrument is used.
instruction manual.
• The manufacturer is not liable for malfunctions or Other precautions:
injuries caused by use of this system under ambient
conditions that deviate from the conditions of use of • Kowa shall not be responsible for:
this system, including the power supply and - Failure or damages caused by modifications, repair
environmental conditions, as described in this or maintenance conducted by any party other than
instruction manual. Kowa and its authorized distributor(s), and
• The manufacturer is not liable for malfunctions or - Failure or damages caused by modifications, repair
injuries caused by fire, earthquake, flood, lightning or or maintenance using any parts other than those
other natural disasters. designated by Kowa.
• The input voltage should always be maintained within • Never disassemble nor adjust this instrument by
±10% of the rated voltage. yourself since it uses precision parts which requires
• Wait approximately 5 seconds (until the power supply special tool for doing so.
stabilizes) after turning on the main switch before
operating any of the panel switches.
4
Precautions Concerning Use of Medical Electrical Equipment
6. In the event equipment should malfunction, the operator should not attempt to correct the problem, but
rather appropriately indicate that the equipment is not operating properly and await repairs by qualified
personnel.
9. Be careful of the possibility that incorrect operation may be caused by strong electromagnetic waves.
This equipment is examined based on IEC 60601-1-2:2001.
The purpose of this standard is to keep safety against the dangerous obstacle in typical medical facilities.
When this equipment is influenced by other equipment, or when it affects other equipment or when there is
such fear, please devise to move this equipment and other apparatus or to make the distance between
those equipment.
Moreover, if there is an unknown point, please consult our company, or an agency beforehand.
5
ACCESSORIES
Instruction manual: 1
6
Contents
INTRODUCTION ---------------------------------------------------------------------------------- 1
Precautions Concerning Use ---------------------------------------------------------------- 4
Precautions Concerning Use of Medical Equipment ------------------------------------ 5
ACCESSORIES------------------------------------------------------------------------------------ 6
Contents -------------------------------------------------------------------------------------------- 7
1. Summary of Equipment ------------------------------------------------------------------ 8
2. Name of Each Part and Functions ---------------------------------------------------- 9
■ Summary of Display ■ --------------------------------------------------------------- 10
3. Procedure of Measurement ----------------------------------------------------------- 11
■ AUTOMATIC MODE ■ ---------------------------------------------------------------- 12
■ MANUAL MODE ■ --------------------------------------------------------------------- 13
4. Measurement Value ---------------------------------------------------------------------- 14
■ ERROR message ■ ------------------------------------------------------------------- 14
■ Display of data marked with asterisk* ■ --------------------------------------- 14
■ LIMIT OF ACCURACY ■ ------------------------------------------------------------- 14
5. Printing of measurement results ---------------------------------------------------- 15
■ Replacement of Printing Paper ■ ------------------------------------------------ 15
6. Menu Mode---------------------------------------------------------------------------------- 16
■ Startup of Menu Mode ■ ------------------------------------------------------------ 16
■ Selection of Each Item ■ ------------------------------------------------------------ 16
■ End of Menu Mode ■ ----------------------------------------------------------------- 16
■ Description of Each Item ■ --------------------------------------------------------- 17
1 ID --------------------------------------------------------------------------------------------------------------------- 17
2 DATE ---------------------------------------------------------------------------------------------------------------- 18
3 AUTO OFF --------------------------------------------------------------------------------------------------------- 18
4 ID IN ----------------------------------------------------------------------------------------------------------------- 19
5 DATA OUT --------------------------------------------------------------------------------------------------------- 19
6 PRINT FORM ------------------------------------------------------------------------------------------------------ 19
7 WARNING ---------------------------------------------------------------------------------------------------------- 19
8 AIR CHECK -------------------------------------------------------------------------------------------------------- 19
7. External Connection --------------------------------------------------------------------- 20
1 Ten Key Pad ----------------------------------------------------------------------------------------------------------- 20
2 Barcode Reader ------------------------------------------------------------------------------------------------------ 20
3 Data Control by Personal Computer -------------------------------------------------------------------------- 20
8. Maintenance . Check -------------------------------------------------------------------- 21
1. Daily Check -------------------------------------------------------------------------------------- 21
2. Replacement of Fuse ------------------------------------------------------------------------- 21
3. How to Mount Chin Rest Paper ------------------------------------------------------------ 21
4. How to Disinfect Forehead Rest Pad and Chin Rest ------------------------------- 22
5. Supplement of Consumed Expendables ----------------------------------------------- 22
6. Periodical Check ------------------------------------------------------------------------------- 22
7. Repair of Equipment -------------------------------------------------------------------------- 22
9. Specification ------------------------------------------------------------------------------- 23
10. Photochemical Hazard ------------------------------------------------------------------ 24
11. Electromagnetic Compatibility (EMC) --------------------------------------------- 25
7
1. Summary of Equipment
■ Features ■
1) You can select 3D or 2D in Automatic Mode for Alignment. You can also select Manual Mode, of course.
2) Alignment information and measurement values after measurement are displayed on 5.6" Color LCD.
3) The measurement values are printed by printer or transferred to personal computer as electronic data.
4) You can enter the patient ID by Ten Key Pad or bar code.
5) Chin rest can be electrically moved up and down.
6) Blink detecting function is provided.
8
2. Name of Each Part and Functions
Caution
When operating this equipment, be careful to prevent
your hand from being caught at arrowed location
(marked with ).
NEVER install this equipment so as to block ventilation
opening.
9
1 Chin rest C Joy Stick
A pedestal for carrying the patient’s chin. You can move the main body in all directions. If you
2 Locking screw turn the joystick, the main body will goes up and down.
It fixes pedestal to prevent movement in all D Display
directions. 5.6” TFT LCD Monitor is used. It displays the
3 Printer Cover alignment of front part of eyes and measurement data.
Replaces printing sheets. E AUTO/MANUAL Switch
4 ✽Clear Switch It switches measurement mode.
It deletes the data marked with ✽ (one biggest F 3D/2D Switch
value) When the measurement mode is automatic, it
5 PRINT Switch switches 3D/2D. For 3D, alignment can be
It prints data or transfers data to external devices. automatically made within ±2mm in forward/
If there is no printed (or transferred) data, the LED of backward direction.
switch lights. G MENU Switch
6 switch When you keep pressing this switch for more than 1
When you press this switch, the Chin rest will goes second, you can call Menu Mode of various setting.
up. During the energy-saving mode, the LED blinks. H CLEAR Switch
7 switch It clears data.
When you press this switch, the Chin rest will goes I Ventilation Opening
down. During the energy-saving mode, the LED blinks. J External Input Terminal
8 Safety Stopper Connect Ten Key Pad and Barcode Reader for ID
It restricts the movement of the pedestal to prevent Input to this terminal.
the measurement nozzle from contact with subject. K External Output Terminal
9 Forehead rest This terminal is used for output of personal computer.
It is applied to and holds the subject’s forehead. L Power Inlet
0 Air supply nozzle Fuseholder is provided.
Air blow is supplied from opening. M Power Switch
A Eye Level Mark
It indicates the standard level of the subject’s eyes.
B Measurement Switch
When you press this switch, air is blown and the
equipment measures the intraocular pressure.
■ Summary of Display ■
Current Measurement
Mode
This message
appears when the
subject’s eye is not
opened sufficiently.
10
3. Procedure of Measurement
1. Operate the joystick and move the pedestal to the position on this
side where the pedestal stops.
2. Fix the subject’s chin and forehead to the eye level mark on the 2 Eye level Mark
forehead rest frame.
Instruct the subject to put his/her face to chin rest and forehead
rest.
• Press or key to move the Chin rest up or down and adjust the
level of the subject’s eyes to the eye level mark.
3. Keep pressing the safety stopper and make the pedestal closer to 3
Caution
Clean the glass part of air supply nozzle on regular basis. If the glass part is stained by contact with the subject’s
eyelashes or stuck dust, you cannot do the measurement correctly. When cleaning, apply a small amount of alcohol
to soft gauze or silbourne paper (lens cleaning paper) and wipe the glass part with it twice.
During the cleaning, be sure not to touch the hole of nozzle of air supply nozzle.
5. Keep looking at the screen and make the air supply nozzle closer to the subject’s side.
• At this time, instruct the subject to look at the green point in the nozzle of air supply.
Caution
To clean the inside of the nozzle, press measurement switch and do the empty shooting a few times before use. At
this time, make sure that there is nobody in front of the nozzle.
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■ AUTOMATIC MODE ■
6. You will see 3 brilliant points on the corneal as shown in the
figure on the right. Move the joystick in all directions so that
the alignment brilliant points inclined to the center will be
covered in the outer circle of double circle.
• When the brilliant points are within the circle, automatic
alignment function in all directions is activated.
8. The trapezoid appears on the screen as shown in Figure A, make it closer to the subject by joystick. When
the alignment is getting better, the screen will be changed as shown in Figure B, and air blow is shot
automatically and measurement is made.
If the display is as shown in Figure C, the measurement nozzle is too close to the subject’s eyes. You hear
alarm sound “Beep” and keep apart the nozzle from the subject’s eye by joystick.
Figure C
Figure A Figure B
9. If you select 3D in automatic mode, automatic alignment in forward/backward direction is activated when the
display becomes as shown in Figures A and C.
Figure D Figure E
If the display as shown in Figure B does not appear or air blow is not shot due to fixation is bad or the
shape of corneal is not good, you can do the measurement by pressing measurement switch as well as
manual mode.
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Caution
• If the alignment display does not appear on the screen, alarm does not sound even if the nozzle becomes closer
to the subject’s eyes.
• In the Menu Mode, if the WARNING is set to OFF, alarm does not sound.
• Alarm sound stops in a short time even if the nozzle does not separate from the subject’s eyes. When the alarm
sounds, draw the nozzle to the operator side and separate the nozzle from the subject’s eyes.
• The warning for approaching by alarm sound is just for supplemental purpose. Be sure to use safety stopper for
safe measurement.
• If the subject does not open his/her eyes sufficiently, intraocular pressure cannot be measured correctly.
Therefore, if the opening of eyes is not enough, a message “OPEN EYE” appears on the screen. At this time, in
automatic mode, measurement cannot be made even if the display is as Figure B. Until either one of upper 2
brilliant points can be seen, instruct the subject to open his/her eye or you open his/her eye by hand.
■ MANUAL MODE ■
6. You will see 3 brilliant points on the surface of corneal as
shown in the right figure.
Move the joystick in all directions so that an brilliant alignment
point inclined to the center comes to the center of doubled
circle.
7. Keep the brilliant point to the center, and make the nozzle
closer to the subject by joystick slowly.
• As well as Automatic Mode, make the nozzle closer to the
subject by joystick until the display becomes as shown in
Figure B of the previous page. Brilliant Alignment Point
13
4. Measurement Value
Measurement Value
Measurement Average
Value
■ ERROR message ■
When the measurement was not made correctly,
“ERROR” message is displayed for a moment.
While this message appears on the screen,
the next measurement cannot be made.
■ LIMIT OF ACCURACY ■
Degree of accuracy claimed for devices with a measuring function.
±1mmHg:more than 0 and less than 30mmHg
±2mmHg:more than 30, 60mmHg or less
14
5. Printing of measurement results
When you press the PRINT switch, the data measured up to that
time is printed. Once printing is finished, the data is deleted.
If needed, write the items "NAME" and sexuality "M/F" by hand after
the data is printed onto paper.
When you press the PRINT switch and if there is no printing paper,
the message on the right will appear.
When you press the CLEAR switch, the display will return to the
normal measurement screen. Until paper is supplied, “PAPER END”
message will appear on the left top of the screen.
Caution
Before replacement of printing paper, make sure that the subject’s chin is placed on the chin rest.
During the replacement of paper, the pedestal can be put out to the subject side.
1. Press the button with green round rim on the printer part. 4
The cover will open.
Caution
Be careful with the inside and outside of printing paper. If it is failed,
nothing is printed on it.
15
6. Menu Mode
This is a Mode for various settings of KT-800.
When you press PRINT switch in Menu Mode, the set items of
menu are printed out.
Caution
Battery is installed inside to maintain the date and contents of set items
of the Menu Mode.
The battery lasts 4-6 months when it is fully charged (for about 12 hours),
but for charging, turn the POWER switch ON for more than 30 minutes
every week.
When the battery is exhausted, the date and the values set by Menu
Mode return to the initial value. Set the value again.
16
■ Description of Each Item ■
1 ID
When you select the ID, the following display appears.
switch : ON
switch : DOWN
AUTO/MANUAL : ENTER
[ID SETTING]
You can set the ID number on this menu.
[ID ON/OFF]
You can set ON/OFF of display of ID number on this menu.
In case of ON : “ID number” appears as shown below. If the PRINT FORM of the Menu Mode is REGULAR,
the “ID number” is printed. When printing is done, 1 is automatically added to “ID number”.
In case of OFF : If the PRINT FORM of the Menu Mode is REGULAR, the printed ID number will be blank as
“ID[ ]”. Use this function when you want to enter the ID number by hand.
ID number
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2 DATE
When the DATE is selected, the following display appears. This is the mode to set the “DATE” and type of
“FORMAT”.
[DATE SETTING]
Date Setting Mode
3D/2D switch/Menu Switch : for setting the date
• switch : for increase and
decrease of value
AUTO/MANUAL Switch : for Entering the value
CLEAR Switch : for clearing the values
[DATE FORMAT]
DATE FORMAT Mode
This menu is to set the format of date which is printed in case of printing the measurement data.
Japan
U.S.A.
Europe
3 AUTO OFF
This menu is to set energy-saving mode. The initial value is “ON”.
ON : If the KT-800 is not operated for a certain time, the monitor will be turned OFF and shifting over to
energy-saving mode (about 5 minutes).
Energy-saving mode is released when you press any switch.(not released by turning joystick) Data
before entering energy-saving mode is saved.
OFF : The KT-800 is not shifting over to energy-saving mode.
18
4 ID IN
This menu is to set the device to be connected to external input terminal (ID IN). Initial value is “NONE”.
TEN KEY : Ten Key Pad can be connected to enter the ID.
BARCODE : Barcode Reader can be connected to enter the ID.
NONE : Nothing connected to external input terminal.
5 DATA OUT
You can set the output data when you press the PRINT switch. Initial value is “PRINT ONLY”.
6 PRINT FORM
This menu is to set the form of measurement results when printing by printer.
Initial value is “REGULAR”.
7 WARNING
This menu is to set ON/OFF of alarm sound for approaching. Initial value is “ON”.
ON Alarm sounds.
OFF Alarm does not sound.
8 AIR CHECK
This menu is to check the status of air blow.
When you select AIR CHECK, the following display appears.
Press the measurement switch on condition that nothing is placed in front of air supply nozzle. After air blows for
five times, each value of A, B and C appears. Check the each value is within the range shown on the right. Enter
the results by AUTO/MANUAL switch. Return to TOP of the Menu Mode and print the results. This data is deleted
when the power is turned OFF.
If any value of A, B and C is deviated from the range, contact your Kowa dealer where you purchased it.
19
7. External Connection
1 Ten Key Pad
Connecting PS/2 style Ten Key Pad to external input terminal, you can enter ID number.
In the Menu Mode, set ID ON/OFF to ON, ID IN to TEN KEY, and PRINT FORM to REGULAR.
2 Barcode Reader
Connecting PS/2 style barcode reader to external input terminal (ID-IN), you can enter ID number. In the Menu
Mode, set ID ON/OFF to ON, ID IN to BARCODE, and PRINT FORM to REGULAR.
Caution
Use RS232C cable of 2m (or shorter).
Caution
20
8. Maintenance . Check
This product is precision equipment. Results of daily maintenance and check may affect the results of
measurement. Read this Chapter carefully to use this product correctly and safely.
1. Daily Check
1) Perform AIR CHECK in the menu mode before starting the measurement (page.19).
2) When the measurement is finished, be sure to turn the POWER switch OFF and put a cap on air supply nozzle. Then
tighten the pedestal stopper and fix the pedestal so that it cannot be moved. Put a dust cover.
3) Clean the stain on enclosure with soft cloth or the like. If the stain is severe, use synthetic detergent. If you use chemicals
such as thinner , benzene, etc. or solvents, materials can be deformed and painting peels off.
4) If you do not use the KT-800 for long time, pull out the power plug from receptacle for safety.
2. Replacement of Fuse
Be sure to turn the POWER switch OFF, pull out the power plug from the
power inlet, then remove the fuseholder by means of flat-bladed
screwdriver.
Check the fuse and replace it with spare fuse, if it was blown out.
Be sure to use designated fuse.
War
Warning
arning
ning
When replacing the fuse, turn the POWER switch OFF and pull out the power plug from the
receptacle. If it is not pulled out, it creates a risk of electrical shock.
Unplug
Use designated fuse provided as accessory in the package. If you use a fuse other than
Warning
High-voltage designated, it creates a risk of fire.
Chin Rest
Dispose of a piece of chin rest paper every time the subject changes.
21
5. Supplement of Consumed Expendables
Order the following expendables with numbers shown in the table.
Order No.
Chin Rest Paper K9L-TB45 #102
Chin Rest Pin K9L-TB45 #101
Printer Paper STH-148
Fuse 21301.6
(T1.6A L250V)
6. Periodical Check
To use the KT-800 safely for long time, we recommend you to check it once a year.
Contact your Kowa dealer where you purchased this KT-800 for contents of check and fees.
7. Repair of Equipment
Whenever the KT-800 must be returned to the manufacturer for repair or maintenance, contact your kowa
dealer.
22
9. Specification
• IEC 60601-1:1988+A1:1991+A2:1995
• EN 60601-1: 1990+A1:1993+A2:1995+A13:1996
According to the type of protection against electric shock.
<CLASS I EQUIPMENT>
According to the degree of protection against electric shock.
<TYPE B APPLIED PART>
According to the degree of protection against ingress of water
as detailed in the current edition of IEC60529.
<IPX0>
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
anaesthetic mixture with air or with oxygen or nitrous oxide.>
According to the mode of operation.
<CONTINUOUS OPERATION>
• IEC 60601-1-2:2001 (EN 60601-1-2:2001)
• ISO 15004:1997 (EN ISO 15004:1997)
23
10. Photochemical Hazard (ISO 15004:1997)
(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
operated 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
instance, 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
Hygienists (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 subject's eye be limited to the minimum level which is necessary for
diagnosis.
Infants, aphakes and persons with diseased eyes will be at greater risk. The risk may also be increased if the
person being examined has had any exposure with the same instrument or any other ophthalmic instrument using
a visible light source during the previous 24 h. This will apply particularly if the eye has been exposed to retinal
photography.
24
11. Electromagnetic Compatibility (IEC60601-1-2: 2001)
KOWA KT-800 is a medical electrical instrument. The medical electrical instrument requires special care
concerning electromagnetic compatibility (EMC). This section describes its suitability in terms of electromagnetic
compatibility 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: 2001.)
1. Carefully handle portable- or mobile-type radio frequency communication unit (RF communications
equipment) 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 malfunctioning, or the
latter itself may malfunction.
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
constantly monitor if the instrument is functioning normally after such use has been adopted.
25
Guidance and manufacturer's declaration - electromagnetic immunity
The KOWA KT-800 is intended for use in the electromagnetic environment specified below.
The customer or the user of the KOWA KT-800 should assure that it is used in such an environment.
Immunity test IEC 60601 Compliance level Electromagnetic environment-guidance
test level
Electrostatic ±6kV contact ±6kV contact Floors should be wood, concrete or ceramic
discharge (ESD) ±8kV air ±8kV air tile. If floors are covered with synthetic mate-
IEC 61000-4-2 rial, the relative humidity should be at least 30%.
Electrical fast ±2 kV for power ±2 kV for power supply Mains power quality should be that of a typi-
transient/burst supply lines lines cal commercial or hospital environment.
Input/output tests are not applicable to
IEC61000-4-4 ±1 kV for input/output RS232C signal transmission cable of 2 m in
lines length.
Surge ±1 kV differential mode ±1 kV differential mode Mains power quality should be that of a typi-
IEC 61000-4-5 ±2 kV common mode ±2 kV common mode cal commercial or hospital environment.
Voltage dips, short <5% UT <5% UT Mains power quality should be that of a typi-
interruptions and (>95% dip in UT) (>95% dip in UT) for 0.5 cal commercial or hospital environment. If the
voltage variations for 0.5 cycle cycle user of the KOWA KT-800 requires continued
on power supply operation during power mains interruptions,
input lines 40% UT 40% UT it is recommended that the KOWA KT-800 be
IEC61000-4-11 (60% dip in UT) (60% dip in UT powered from an uninterruptible power sup-
for 5 cycles for 5 cycles ply or a battery.
70% UT 70% UT
(30% dip in UT) (30% dip in UT)
for 25 cycles for 25 cycles
<5% UT <5% UT
(>95% dip in UT) (>95% dip in UT)
for 5 sec for 5 sec
Power frequency 3 A/m 3A/m Power frequency magnetic fields should be
(50/60Hz) at levels characteristic of a typical location in
magnetic field a typical commercial or hospital environment.
IEC61000-4-8
NOTE UT is the A.C. mains voltage prior to application of the test level
26
Guidance and manufacturer's declaration - electromagnetic immunity
The KOWA KT-800 is intended for use in the electromagnetic environment specified below.
The customer or the user of the KOWA KT-800 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
equipment should be used no closer to any
part of the KOWA KT-800, including cables,
than the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
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