NIDEK INCORPORATED: 47651 Westinghouse Drive Fremont, California 94539, U. S. A.
(United States Agent)Telephone: (510) 226-5700
Facsimile: (510) 226-5750
NIDEK SOCIETE ANONYME: Europarc 13, rue Auguste Perret, 94042 CRETEIL, France
(Authorized Representative)Telephone: (01) 49 80 97 97
Facsimile: (01) 49 80 32 08
2005.1
32725-P902G
Printed in JAPAN
BEFORE USE OR MAINTENANCE, READ THIS MANUAL.
The Operator’s Manual contains information necessary for the operation of the NIDEK
AUTO REF/KERATOMETER Model ARK-30.
This manual includes operating procedures, cautions for safety, and specifications. The
device complies with ISO 10342 (Ophthalmic instruments - Eye refractometers). IEC
and UL standards are applied in this manual. The dioptric powers are indicated with
reference wavelength λd = 587.56 nm. For correct use, this manual is needed. Especially,
the cautions for safety and operating procedures must be thoroughly understood before
using the device. Keep this manual handy to verify use whenever necessary.
There are no user-serviceable parts inside the device except the printer paper, fuse, and
battery. If you encounter any problems or have questions about the device, contact your
authorized distributor.
(This applies only to the equipments whose power source is 100/120Vac.)
APPENDIX. A GLOSSARY ................................................................................................. A-1
INDEX ........................................................................................................... End of this manual
[This page is intentionally left blank.]
INTRODUCTION
§
1
1.1 Outline of the Device
The NIDEK Auto Ref/Keratometer ARK-30 is an objective refraction measurement device that
contains the functions for measuring refractive errors such as spherical power, cylindrical power,
and cylinder axis and the functions for measuring corneal shapes such as the corneal curvature
radius (corneal refractive power), angle of meridian, and corneal cylindrical power.
The measured value of refractive errors are mainly used as the reference of the lens prescription
for correction of visual acuity in spectacle and contact lenses. The measured value of the corneal
curvature is used for the prescription of visual acuity corrective lenses such as contact lenses. It
is also used to observe the corneal curvature radius necessary for setting the refractive power of
intraocular lens that will be implanted after cataract surgery and the change process of the
postoperative corneal shape after corneal surgery.
This device is a hand-held type that allows children who cannot fix their head on the stationary
chinrest and lying patients to be measured. As well as the compact station, the device can be
easily moved, which makes the measurement possible in a sick room or operating room where
the measurement is not possible with the stationary type.
The device consists of a measuring unit and a station. The station is provided with a power supply,
a charger, and a printer to print the measured results. The measuring unit is provided with a color
LCD monitor and a control panel, etc. to perform alignment and operation.
To make the measurements easier, an auto-shot function is available, which will start the
measurement automatically when the patient’s eye is aligned and focused.
The built-in RS-232C interface allows you to output data to a personal computer.
1.2 Indications for Use
The Model ARK-30 Auto Ref/Keratometer is a diagnostic device that is indicated for use in the
automated measurement of refractive errors of the eye, and in the measurement of the corneal
curvature of the eye.
1.3 Classifications
[Classification under the provision of 93/42EEC (MDD)] Class IIa
The ARK-30 is classified as a Class IIa device.
[Form of protection against electrical shock] Class I
The ARK-30 is classified as a Class I device. The Class I device is a device in which protection
against electric shock does not rely solely on basic insulation. The Class I device includes
additional safety precaution that provides for a connection of accessible conductive parts to a
protective (earth) grounding conductor in the fixed wiring of the installation.
Use a power outlet which is equipped with a ground terminal.
1 - 2
[Degree of protection against electrical shock] Type B applied part
The ARK-30 is provided with a Type B applied part.
The Type B applied part provides an adequate degree of protection against electrical shock,
particularly regarding the following:
- allowable leakage currents
- reliability of the protective earth ground connection (if applicable)
[Degree of protection against liquid entry] IP20*
The ARK-30 is classified as a normal device, as such provides only minimal protection against
liquid intrusion.
Avoid splashing water or another liquid on or in the device.
[Degree of protection against flammability]
The ARK-30 is classified as a device not suitable to be used in a potentially flammable
environment.
Do not operate the device near flammable type materials.
[Method (s) of sterilization or disinfection recommended by the manufacturer]
The forehead rest can be cleaned with a cloth dampened with rubbing alcohol as necessary.
[Mode of operation]
Classification of the ARK-30: Continuous operation
1
1.4 Symbol Information
This symbol on the device indicates that caution must be taken.
Refer to the operator’s manual before use.
This symbol indicates that the degree of protection against electrical shock of the applied
part is classified as a Type B applied part.
This symbol on the control panel indicates the start button for placing the device in the
measurement mode.
This symbol on the control panel indicates the power button for turning the measuring
unit on and off. Pressing the button turns the measuring unit on and off.
*1In accordance with IEC 60529
1 - 3
This symbol on the station indicates that the power is on.
This symbol on the station indicates that the power is off.
This symbol on the control panel indicates the print button for transmitting the measured
results to the station for printing out.
On the station, this symbol indicates the feed button for feeding the printer paper.
This symbol on the control panel indicates the parameter button for displaying the menu
to change the settings on the screen.
This symbol on the control panel indicates the memory button to store the median
values of the measured results.
On the station, the illuminated lamp for this symbol indicates that AR and KM data that
will be outputted externally are being stored in memory.
This symbol on the control panel indicates the angle correction button for rotating the
measuring optical axis 90°.
This is the symbol on the control panel and station. The lamp with this symbol flashes
while the battery is being charged.
This symbol indicates the fuse rating.
This symbol indicates that the device must be supplied only with alternating current.
This symbol indicates the connection part that is suitable for direct current only.
This indicates the input part.
This indicates the output part.
This symbol on the station indicates that power is supplied to the station and the power
switch is turned on when the lamp with this symbol is illuminated.
SAFETY
§
2
In this manual, a Signal Word is used to designate the degree or level of safety alerting.
The definition is as follows:
CAUTION:Indicates a potentially hazardous situation which, if not avoided,
may result in minor or moderate injury or property damage accident.
Even situations indicated by “CAUTION” may result in serious injury under certain
conditions. Safety precautions must be strictly followed at all times.
2.1 Cautions during Use
CAUTION
• Do not modify or touch the inside of the device.
This may result in an electric shock or a malfunction.
• Do not dismantle or modify the battery.
Heat generation, explosion, or combustion may result.
• Never remove the power cord from the wall outlet by holding on to the cord.
This may damage the cord and cause a short circuit or an electric shock. Grasp the plug
then pull.
• Do not place heavy objects on the power cord to prevent damage to the power cord, and
a fire or an electric shock.
• Immediately replace the power cord if the internal wires are exposed, the device power
turns on or off when the power cord is moved, or the cord and/or plug becomes extremely
hot.
This may result in an electric shock or a fire.
• Do not use the device for other than the intended purpose.
NIDEK will not be responsible for accidents or a malfunction caused by carelessness.
• Wipe between the prongs of the main plug with a dry cloth every once in a while.
If dust settles between the prongs, the dust will collect moisture, and a short circuit or a
fire may occur.
• Before measuring a patient, wipe the forehead rest with a clean cloth.
If necessary, wipe the forehead rest with a cloth dampened with rubbing alcohol.
2 - 2
CAUTION
• In the event of a malfunction, do not touch the inside of the device, but disconnect the
power cord from the wall outlet and contact your authorized distributor.
• There may be cases where a measuring eye (R/L) is not detected correctly, depending on
the shape of the patient’s face.
Change the setting by pressing the R/L selection button
measuring eye side is not correct.
• When moving the device with your hand, use the hand strap or neck strap (option). To
move the device, be sure to hold the grip. Do not hold the hand strap only.
Accidentally dropping the device may cause an injury or a malfunction.
For a malfunction caused by dropping the device, the warranty is not valid. You must
pay to repair the device.
• Bring the device to the patient’s face after drawing out the forehead rest.
The device may contact the patient’s face.
if the indication of the
• Keep the measuring window free of fingerprints and dust to prevent the measurement
accuracy from decreasing.
• The date and time may deviate if the battery is removed from the measuring unit for more
than 12 hours. In this situation, reset the date and time.
• The measured values of objective refractive power obtained by the ARK-30 are intended
to be used as a reference of lens prescription for the correcton of visual acuity with spectacle
or contact lenses. Manifest refraction must be used as the basis for the spectacle or
contact lens prescription.
2 - 3
CAUTION
• Information on the avoidance of overexposure to potentially hazardous optical radiation
(ISO 15004: 1997)
Spectrally weighted photochemical radiances LB and LA give a measure of the potential
that exists for 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 device gives a measure of hazard potential when
the device is operated at maximum intensity and maximum aperture. The values of L
or LB for the ARK-30 are sufficiently low as shown on the following page.
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 0.5 mW/(cm2•sr), 480 min
irradiation of the dilated (8 mm diameter) pupil would cause the retinal exposure dose
level to attain the recommended exposure limit. If the value of radiance were reduced
to 0.05 mW/(cm2•sr), ten times that time (i.e. 4800 min) 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).
The following page shows the graph of spectrum output for the ARK-30. Patients will
be at low risk of acute optical radiation with the ARK-30. However, it is recommended
that the intensity of light directed into the patient’s eye be limited to the minimum level
which is necessary for diagnosis. The total of the retinal exposure dose must be carefully
watched for infants, aphakes and persons with diseased eyes who are at greater risk
when other ophthalmic devices with a high level of radiance are used in conjunction.
A
2 - 4
CAUTION
Spectrum output of all light source during AR measurement (maximum light intensity)
AR-20/ARK-30
ARK-30
10
9
8
7
6
5
4
3
Irradi-
ance:
放射照度:(μW/c㎡)
2
1
0
3004005006007008009001000
Wavelength:
波長:(nm)
Spectrum irradiance
1
*
LA (µW/cm2/sr) 380 - 700 nm0.527
B
2
*
(µW/cm2/sr) 305 - 700 nm0.056
L
Spectrum output of all light source during KM measurement (maximum light intensity)
The patient environment represents a space where there is a possibility of direct contact between
the patient or the operator and third person.
When another type of device is used in the patient environment, use a device that complies
with IEC 60601-1. If the devices that do not comply with IEC 60601-1 are used, it is necessary
to use an isolating transformer to power the device or to connect the devices to additional
protective grounding.
Radius of 1.5 m
1.5 m
2.5 m
1.5 m
2.2 Storage
CAUTION
• Store the device in a place that is dry and free from poisonous gas.
• The device must be maintained under the following conditions during transport and storage
(packed condition).
Environmental conditionsTemperature:–20ºC to 60ºC
Humidity:10% to 95% (No condensation)
A place with low dust
A place not exposed to direct sunlight
2.3 Transport
CAUTION
2 - 6
• Do not drag the cord or cables when moving the device to prevent an injury or a malfunction.
• Place the device in the shipping carton or optional carrying case when moving to another
location. Do not use the carrying case if you ask the moving company to take care of the
device.
Excessive vibration or impact may cause a device malfunction.
2.4 Installation
CAUTION
• Do not install the device near water.
Keep water away from the device to prevent an electric shock or a malfunction.
• Install the device on a stable and level surface free from vibration and impact to prevent
a malfunction or an injury caused by knocking over the device.
• For printing, wireless communication is performed using infrared beams from the
measuring unit to the station. Install the device where the light-receiver window of the
station is not exposed to intense light such as sunlight and illumination that contains
infrared rays.
If the intense external light comes into the light-receiver window, printing may not be
performed correctly. Cut off sunlight with a curtain and turn off nearby illumination.
2 - 7
CAUTION
• Install the device in an environment that meets the following conditions.
Conditions in useTemperature:10ºC to 40ºC
Humidity:30% to 75% (No condensation)
Pressure:700 hPa to 1060 hPa
A place with little dust
A place with little external light
A place free of vibration and impact
• This device complies with the limits for medical devices in IEC60601-1-2: 2001, EN60601-
1-2: 2001, and Medical Device Directive 93/42/EEC. These limits are designed to provide
reasonable protection against harmful interference in a standard medical installation. This
device generates, uses and can radiate radio frequency energy and, if not installed and
used in accordance with the instructions, may cause harmful interference to other devices
in the vicinity. However, there is no guarantee that interference will not occur in a particular
installation. If this device does cause harmful interference to other devices, which can be
determined by turning the device off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
- Reorient or relocate the receiving device.
- Increase the distance to the device.
- Correct the device into an outlet on a circuit different from that to which the other
device (s) are connected.
- Consult the manufacturer or field service technician for assistance.
• In installation and operation of the device, observe the following instructions about EMC
(electromagnetic compatibility):
- Do not use the device simultaneously with other electronic equipment to avoid
electromagnetic interference with the operation of the device.
- Do not use the device near, on, or under other electronic equipment to avoid
electromagnetic interference with the operation of the device.
- Do not use the device in the same room with other equipment such as life-support equipment,
other equipment that has major affects on the life of the patient and results of treatment, or
other measurement or treatment equipment that involves small electric current.
- Do not use the device simultaneously with portable and mobile radio frequency
communication systems because it may have an adverse effect on operation of the
device.
- Do not use cables and accessories that are not specified for the device because that
may increase the emission of electromagnetic waves from the device or the system
and decrease the immunity of the device to electromagnetic disturbance.
• The Electromagnetic Compatibility Directive sets the essential requirements for electrical
and electronic equipment that may disturb, or be disturbed by, other equipment. The ARK30 complies with these requirements as tabled on pages 11-1 to 11-3. Follow the guidance
in the tables for use of the device in an electromagnetic environment.
2.5 Wiring
CAUTION
• Be sure to use a wall outlet which meets the requirements of the power specification.
If the line voltage is too high or too low, the device may not give full performance. A
malfunction or a fire may occur.
• Do not put many loads on one electrical outlet.
A fire may occur.
• Insert the mains plug into a grounded wall outlet.
An electric shock or a fire may occur in case of a device malfunction or power leakage.
• Securely connect the main plug into a wall outlet.
A loose connection may cause a fire.
• Be sure to connect the interface cable, checking the symbols of input (IN: ) and output
(OUT: ).
Correct communications will not be possible.
2 - 8
2.6 After Use
CAUTION
• If the device will not be used for a long time, disconnect the power cord from the wall
outlet to prevent a fire.
• If the device will not be used for a long time, remove the battery from the device to
prevent rust and deterioration of the battery.
• Store the battery with the contact away from metal.
The contact is recessed to prevent easy contact. However, if the battery is stored with a
metal necklace, etc., it may result in a short circuit, which may generate heat or a
malfunction.
• When the device is not in use, turn off the power and put the dust cover on the device to
prevent dust from affecting the measurement accuracy.
2 - 9
2.7 Maintenance and Checks
CAUTION
• Use the specified fuses to replace the old ones to prevent a fire.
• Disassembly is not permitted except at NIDEK or your authorized distributor.
• Never use organic solvents such as paint thinner to wipe the exterior.
This may ruin the surface.
• When charging and replacing the battery, use the specified battery and charger (station or
measuring unit) only. In addition, do not put foreign matters such as metal into the battery
slot to prevent a malfunction or a fire.
• Do not discharge the battery in other devices. Do not connect the positive and negative
terminals with metal such as wire to prevent damage, deterioration, and shortened lifespan of the battery.
• Do not dismantle or modify the battery to prevent heat generation, explosion, or
combustion.
• Replace the printer paper with the specified paper only to prevent damage to the head.
• Before sending the device back to NIDEK for repair or maintenance, wipe the surface
(especially the area that contacts the patient’s skin) of the device with a clean cloth
immersed in ethyl alcohol for disinfection.
• Contact NIDEK or your authorized distributor to check whether the device needs the
measurement accuracy calibration if the AR-measured results are largely different from
the subjective measurements.
2.8 Disposal
CAUTION
• Follow local governing ordinances and recycling plans regarding disposal or recycling of
device components.
Especially the disposal method of lithium-ion batteries varies according to the
government. A rechargeable lithium battery is used in the device. Follow the local
governing ordinances and recycling plans when disposing of a board with lithium
batteries.
• When disposing of packing materials, sort them by material and follow the local ordinances
and recycling regulations.
2.9 Labels
To catch the attention of the user, some labels and indications are provided on the device.
[Measuring unit]
2 - 10
2 - 11
[Station]
200-240 V range
100-120 V range
[Underside of battery]
2 - 12
CONFIGURATION
§
3
[Measuring unit]
R/K selection button
LCD screen
R/L selection button
Memory button
CYL mode selection button
Angle correction button
Start button
Print button
Parameter setting button
Power button
Grip
Charge indicator
3 - 2
Angle correction button
Used to rotate the main body 90º when the
patient is measured from the side.
This is used to measure a patient who is
lying down.
When the parameter “41: SAGITTAL” is
set to “YES”, pressing this button starts
the sagittal radius measurement.
CYL mode selection button
Establishes the CYL mode of measured re-
sults. Pressing this button changes the mode
in the order of CYL – → CYL + → CYL ± →
CYL – → •••.
• CYL + (Plus reading)
Cylinder data is displayed by the + reading.
• CYL – (Minus reading)
Cylinder data is displayed by the – reading.
• CYL ± (Mix reading)
In the AR measurement, cylinder data is
displayed by the + reading when the refractive error is positive for any axis angle.
In other cases, cylinder data is displayed
by the – reading.
In the KM measurement, cylinder data is
displayed by the – reading.
See page 4-7 for details of the CYL mode.
Memory button
Stores the measured results in memory.
The memory function stores the measured
results of 30 patients (60 eyes).
R/K selection button
Changes the measurement mode.
The mode changes in the order of R/K
mode (Serial AR & KM measurements)→
R mode (AR measurement)→ K mode
(KM measurement)→ R/K mode→ •••.
LCD screen
Displays the patient’s eye, target, focusing
indicator, measured values, and measurement
count, etc.
The color of the characters and the background on the LCD screen can be selected
from a combination of 28 kinds.
Start button
Places the device into the measurable state
from standby.
Print button
Prints measured results, etc.
Parameter setting button
Used to change the settings of the device.
Power button
Turns the measuring unit on and off. Pressing this button turns on the power and viceversa.
Turning the power on places the device
into the standby mode.
The position of the chart is initialized and
the chart lamp lights up.
R/L selection button
Sets the measuring eye. Every time the button is pressed, the indication changes in the
order of (or )→ <>→ <>→
(or )→ •••.
If alignment is performed in the AUTO mode,
(right-eye) or (left-eye) will be identified automatically.
<> (<>) indicates that the right eye (left
eye) has been manually set.
Grip
Used to hold the measuring unit. The battery
holder is mounted inside. Open the cover to
replace the battery.
Charge indicator
Flashes while the battery in the measuring unit
is being charged.
Window for optical
communications and
measuring eye (R/L)
detection
Lock switch
Slide this downward to
remove the grip cover.
Hand strap mounting hooks
Hand strap is to be attached to prevent
accidental drop.
Stand screw
Neck strap mounting hooks
Optional neck strap is to be attached.
Cable connector
Eye mask
Open this mask to shield the patient’s eye
which is not measured.
This allows the patient to fixate his/her eye
easier.
To avoid damage from impact, the eye mask
is easily detached. To attach it, push lightly
aligning the hinge part with the main body.
Eye level marker
A guide for the patient’s eye level for measurements. It is located at both the front and
back sides of the eye mask.
Adjust the measuring unit so that the center of the patient’s eye is aligned with this
line.
3 - 4
Measuring window
The patient looks at the chart through this
window.
Keep this window clean. The measuring
window checker allows automatic confirmation of cleanliness.
Forehead rest
Place it against the patient’s forehead (top of
eyebrow) to stabilize the position of the measuring unit.
The push-type lock forehead rest can be
drawn out once it is pushed lightly.
Use the forehead rest so that the measuring unit will not contact the patient’s face.
Stand screw
This screw secures the measuring unit to the
portable stand (option).
Cable connector
Connector for the cable when the measuring
unit is used by deriving power from the station.
The battery can be recharged with the battery
installed in the measuring unit.
Printing is possible by the connecting cable.
3 - 5
[Station]
Feed button
Printer
Memory lamp
Charge lamp
Pilot lamp
Measuring unit stage
Light-receiver window for printing
Cable connector
Printer
Prints measured results, etc.
Feed button ()
Feeds the printer paper. While this button is
pressed, the paper is fed.
Memory lamp ()
Illuminates while data to be transmitted to an
external computer, etc. is stored.
Charge lamp ()
Flashes while the battery is being charged.
This lamp stays illuminated after the charging is completed.
Pilot lamp ()
Illuminates when the station is supplied with
power and operating.
3 - 6
Measuring unit stage
The measuring unit is put on this stage when
not in use.
Light-receiver window for printing
Receives the signal from the measuring unit
during printing.
The communication distance between the
measuring unit and station is within 1
meter.
Cable connector
Connector for the cable when the measuring
unit is used by deriving power from the station.
3 - 7
Data input connector Data output connector
Power connector
Power switch
Battery slot
Cable hanger
Data input connector*
The interface cable from a lensmeter imports
measured values from the NIDEK’s
lensmeter.
The ARK-30 measured results are exported
from the data output connector. The imported
LM measured results are also exported from
the data output connector.
Data output connector*
The interface cable exports measured values
to an external computer.
Power connector
The supplied power cable is connected here.
This is the combination type with a fuse
holder.
Use the specified fuses.
Spare fuses are mounted in the spare fuse
holders inside the printer cover of the station.
3 - 8
Battery slot
The battery is inserted for recharge.
When the battery is inserted, charging will
start automatically and the charge lamp
() will flash.
Cable hanger
When the cable is not in use, it is placed on
this hanger.
The hanger can be easily detached since it
is attached by a magnet.
* Accessory equipment connected to the analog and digital interfaces must be certified according
to the appropriate national standards (for example, UL1950 for Data Processing Equipment
UL 2601-1 for Medical Equipment, and CSA C22.2 No. 601-1, EN 60601-1 and IEC 60601-
1.) Furthermore, all configurations shall comply with the system standard IEC 60601-1. Anyone
who connects additional equipment to the signal input part or signal output part is responsible
for making sure that the system complies with the requirements of the system standard IEC
60601-1. If in doubt, consult the technical service department or your local representative.
3 - 9
[LCD screen]
This is a sample measurement screen in the R/K mode.
Displays the latest measured results. The indicated items vary according to the measurement mode (R/K mode, R mode, K mode).
Battery remaining indicator
CYL mode indication
Corneal luminous spot
Other spots around are the
luminous spots of measuring light and sensor.
Measuring eye
Focusing indicator
Indicates the distance between the measuring
unit and the patient’s eye. This is a guide for
focusing.
Measurement mode
Indicates the selected measurement mode, R:
AR measurement, K: KM measurement, R
and K: R/K measurement. The figures shown
on the right and left represent the number of
measurements for each eye.
AXIS correction mark
This is shown when AXIS is corrected by 90º
with the angle correction button .
Target
Used to bring the patient’s eye to the center
of the measuring optical axis as a guide.
Patient No.
Displays the measured patient No. in a serial
number.
The number is set in the parameter setting
mode.
Battery remaining indicator
Indicates the remaining charge amount of the
battery installed in the measuring unit.
() indicates that the battery is getting
weak and the battery needs recharging.
CYL mode indication
Displays the established CYL mode.
Measuring eye
Displays the right-side or left-side of the detected patient’s eye.
This can be manually set by pressing the
R/L selection button .
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