Nidek Medical AR-600 User manual

NIDEK
AUTO REFRACTOMETER
Model AR-600
OPERATOR’S
MANUAL

BEFORE USE OR MAINTENANCE, READ THIS MANUAL.
This Operator’s Manual contains information on operating procedures of the NIDEK
AUTO REFRACTOMETER Model AR-600, cautions for safety, specifications,
accessories, and maintenance suggestion.
The instrument complies with ISO 10342 (Ophthalmic instruments - Eye
Refractometers). IEC 60601-1 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, cautions for safety and operating procedures must be
thoroughly understood before using the instrument. Be sure to keep this manual together
with the instrument and read it whenever needed.
There are no user-serviceable parts inside the instrument except a printer paper and
fuses. Therefore, if you find any problems or have questions about the instrument
during operation, please contact your authorized distributor.
(This applies only to the equipments whose power source is 100/120Vac.)

Table of Contents
§
1INTRODUCTION ......................................................................................................... 1-1
1.1 Outline of the Product .............................................................................................. 1-1
1.2 Indications for use .................................................................................................... 1-1
1.3 Classification ............................................................................................................ 1-1
1.4 Symbol Information ................................................................................................. 1-2
§
2SAFETY.......................................................................................................................... 2-1
2.1 Operation .................................................................................................................. 2-1
2.2 Storage ...................................................................................................................... 2-2
2.3 Transference ............................................................................................................. 2-2
2.4 Installation ................................................................................................................ 2-3
2.5 Wiring ....................................................................................................................... 2-4
2.6 After Use .................................................................................................................. 2-4
2.7 Maintenance and Checks .......................................................................................... 2-4
2.8 Disposal .................................................................................................................... 2-5
2.9 Labels ....................................................................................................................... 2-6
§
3CONFIGURATIONS..................................................................................................... 3-1
§
4OPERATING PROCEDURES .................................................................................... 4-1
4.1 Operation Flow ......................................................................................................... 4-1
4.2 Preparation for Measurement ................................................................................... 4-1
4.3 AR (Refractive Power) Measurement ...................................................................... 4-6
4.4 PD (Pupil Distance) Measurement ........................................................................... 4-8
§
5PRINTOUT ................................................................................................................... 5-1
5.1 Printing Measurement Results ................................................................................. 5-1
5.2 Eyeprint .................................................................................................................... 5-4
§
6OTHER FUNCTIONS .................................................................................................. 6-1
6.1 System Setups .......................................................................................................... 6-1
6.2 Setting Date and Time .............................................................................................. 6-8
6.3 Entering Comments .................................................................................................. 6-9
§
7TROUBLESHOOTING ................................................................................................ 7-1
Page

§
8MAINTENANCE ........................................................................................................... 8-1
8.1 Replacing Printer Roll .............................................................................................. 8-1
8.2 Fixing a Batch of Chin Rest Paper ........................................................................... 8-3
8.3 Replacing Fuses........................................................................................................ 8-4
8.4 Cleaning the Measuring Window ............................................................................. 8-6
8.5 Cleaning Exterior ..................................................................................................... 8-7
8.6 List of Parts for Replacement ................................................................................... 8-7
§
9IC CARD SYSTEM (OPTIONAL) ............................................................................ 9-1
§
10 SPECIFICATIONS .................................................................................................... 10-1
§
11 ACCESSORIES.......................................................................................................... 11-1
11.1 Standard Accessories ............................................................................................ 11-1
11.2 Optional Accessories ............................................................................................ 11-1
APPENDIX.A Glossary ......................................................................................................... A-1
APPENDIX.B Index .............................................................................................................. B-1
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§1
INTRODUCTION
1.1 Outline of the Product
This instrument is an auto refractometer, which objectively measures the refractive power of
patient’s eyes with infrared rays to obtain spherical, cylindrical powers and cylinder axis of lens,
which may correct the patient’s vision into emmetropia.
This instrument has a main body and a measuring unit integrated on one base. On the base is a
chin rest on the patient’s side and a printer on the operator’s side, which makes an output of
measurement results. On the main body is a TV monitor, switches, and a joystick, which are
used to make alignment or manipulation. The measuring unit has a measuring window, which
the patient looks into and which the infrared rays radiate on the patient’s eye.
1.2 Indications for use
The Model AR-600 Auto Refractometer is a diagnostic instrument that is indicated for use in
the automated measurement of refractive errors of the eye.
1.3 Classification
[Classification under the provision of 93/42/EEC (MDD)] Class II a
The AR-600 is classified into Class IIa system.
[Form of protection against electrical shock] Class
The AR-600 is classified as a class I instrument.
The class I instrument is an instrument in which protection against electric shock does not
rely on basic insulation only, but which includes an additional safety precaution that provides
for connection of accessible conductive parts to a protective (earth) conductor in the fixed
wiring of the installation. Therefore; accessible conductive parts cannot become activated in
the event of failure in the basic insulation.
Use the power outlet which is equipped with a ground terminal.
[Degree of protection against electrical shock] Type B Applied Part
The AR-600 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)

1 - 2
[Degree of protection against ingress of liquids] IP 20
The AR-600 is classified as IP20.*1
AR-600 is a normal instrument, which is provided with an enclosure not completely waterproof.
Avoid splashing water on the instrument.
[Degree of protection against flammability]
The AR-600 is classified as an instrument not suitable to be used in a potentially flammable
environment.
Do not use near flammable materials.
[Method(s) of sterilization or disinfection recommended by manufacturer]
It is possible to wipe the forehead rest and chin rest with a cloth dampened with alcohol as
necessary.
[Mode of operation]
Classification of AR-600: Continuous operation
1.3 Symbol Information
This symbol on the body indicates that caution should be taken.
This 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 power switch indicates the power is ON.
This symbol on the power switch indicates the power is OFF.
Fuse rating.
This indicates the interface connector for LENSMETER.
This indicates the interface connector for an external computer, etc.
This indicates that the instrument must be supplied only with alternating current.
This indicates the knob for adjusting contrast.
This indicates the knob for adjusting brightness.
*1 In accordance with IEC 60529

§2
SAFETY
In this manual, a Signal Word is used to designate a degree or level of safety alerting,
whose definitions are as follows.
CAUTION: Indicates a potentially hazardous situation which, if not avoided,
may result in minor or moderate injury or property damage.
Even the cases mentioned in CAUTION may result in serious injury under a certain
situation. Be sure to observe the instructions of CAUTION.
2.1 Operation
CAUTION
• Never disassemble nor touch the inside of the instrument.
This may result in electrical shock or instrument malfunction.
• Do not hold the power cord, but hold the mains plug to disconnect it from an outlet.
A break in the internal wire of the cord may result in a short circuit or an electric shock.
• Never put a heavy object on the power cord nor catch the cord between any objects.
The cover of the cord may get ragged and may cause a fire or electric circuit.
• If the metal core of the power cord is exposed, power turns on and off by shaking the cord,
or cord/plug gets so heated that one cannot hold it, it means that the cord is damaged.
Exchange the cord immediately.
This may cause an electric shock or a fire.
• Do not use the instrument for other than the intended purpose.
NIDEK will not be responsible for accidents or malfunction caused by such carelessness.
• Wipe between the prongs of mains plug with a dry cloth every once in a while.
If a dust settles between the prongs, the dust easily takes up moisture, and the damp
dust may cause a short circuit and a fire.
• The measured values of objective refractive power obtained by the AR-600 are intended
to be used as a reference of lens prescription for the correction of visual acuity with
spectacle or contact lenses. Manifest refraction must be used as the basis for spectacle or
contact lens prescription.

2 - 2
CAUTION
• In advance of a measurement of each patient, wipe the forehead rest and chin rest with a
clean cloth. Moreover, remove one chin rest paper for each patient if a bunch of the chin
rest paper is fixed on the chin rest. If necessary, wipe the forehead rest and chin rest using
a cloth dampened with rubbing alcohol.
• In the event a failure occurs in the instrument, do not touch the inside of the instrument,
but remove the power cord from the outlet and contact your authorized distributor.
• Keep the measuring window away from fingerprints and dust.
The measurement accuracy may deteriorate substantially.
• Information on the avoidance of overexposure to potentially hazardous optical radiation (ISO
15004: 1997)
Spectrally weighted photochemical radiances LBand LAgive a measure of the potential that
exists for a beam of light to cause photochemical hazard to the retina. LBgives 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. The values of LAor LB
for the AR-600 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 1 mW/(cm2•sr), 240 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 0.1 mW/(cm2•sr), ten
times that time (i.e. 2400 min) would be needed to reach the recommended limit. The
recommended exposure dose is based on calculations arising from theAmerican 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 AR-600. Patients will be at
low risk of acute optical radiation with the AR-600. However, it is recommended that the
intensityoflight directedintothe patient’seyebe limited totheminimum levelwhichis 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
instruments with a high level of radiance are used in conjunction.

2 - 3
LA (µW/cm2/sr) 380 - 700 nm 1.158
LB (µW/cm2/sr) 305 - 700 nm 0.089
AR-630A
0
1
2
3
4
5
6
7
300 400 500 600 700 800 900 1000
波長：(nm)
放射照度：(μW/c㎡)
Irradiance:
Wavelength:
CAUTION
Spectrum output of all light source duringAR measurement (maximum light intensity)
Spectrum irradiance
*1LA: Spectrally weighted photochemical aphakic source radiance
*2LB: Spectrally weighted photochemical phakic source radiance

2 - 4
{


Patient environment
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 1.5 m
2.5 m

2 - 5
CAUTION
• In advance of a measurement of each patient, wipe the forehead rest and chin rest with a
clean cloth. Moreover, remove one chin rest paper for each patient if a bunch of the chin
rest paper is fixed on the chin rest. If necessary, wipe the forehead rest and chin rest using
a cloth dampened with rubbing alcohol.
• In the event a failure occurs in the instrument, do not touch the inside of the instrument,
but remove the power cord from the outlet and contact your authorized distributor.
• Keep the measuring window away from fingerprints and dust.
The measurement accuracy may deteriorate substantially.
2.2 Storage
CAUTION
• Do not store the instrument in a place where it may get wet or where poisonous gas or liquid is
stored.
• Avoid storing the instrument in an area with excessive heat, humidity, or dust.
To preserve the appearance or internal parts of the instrument, avoid direct exposure to
sunlight.
2.3 Transference
CAUTION
• Do not drag the instrument by its cord or cable.
This may cause possible injury or instrument damage.
• To carry the instrument, hold it from the side with both your hands on its base. (Do not
ever hold the forehead rest to lift up the instrument.)
This may result in possible injury or instrument damage.
• To transfer the instrument to another location, store the instrument in a shipping carton or
optional carrying case to carry. In such cases, never lock the main body with the locking
knob.
Breakdown of the instrument may result.

2 - 6
2.4 Installation
CAUTION
• Before connecting power cord or interface cable, provide a stable, level, and open space.
Since receptacles are under the base unit, the instrument may fall down and may cause
injury or instrument malfunction.
• Do not install the instrument near water.
If water gets into the internal structure, there is the possibility of an electric shock or
instrument malfunction.
• Install the instrument in a stable and level place where vibration or shock does not occur.
The instrument may not perform measurement correctly or may malfunction. Also, if
the instrument falls down because of any accidental shock, it may result in possible
injury.
• This instrument has been tested and found to comply with the limits for medical devices
to the IEC 60601-1-2: 1993, EN60601-1-2: 1994 and Medical Device Directive 93/42/
EEC. These limits are designed to provide reasonable protection against harmful
interference in a typical medical installation. This instrument 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
instrument does cause harmful interference to other devices, which can be determined by
turning the instrument off and on, the user is encouraged to try to correct the interference
by one of the following measures:
- Reorient or relocate the receiving device
- Increase the separation between the instrument.
- Connect the instrument 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 help.
• Install the instrument in the following conditions.
A dust free environment
A light interference free environment
A vibration and shock free environment
• Install the instrument in a place where a temperature and humidity can be controlled to
the following. Moreover, be sure to use the instrument under the following conditions.
Temperature : 10 - 40ºC
Humidity : 30 - 75% (non-condensing)

2 - 7
2.5 Wiring
CAUTION
• Be sure to use the power outlet which meets the requirements of the power specification.
If the line voltage is too high or too low, the instrument may not give full performance.
Malfunction or a fire also may occur.
• Be sure to use a (HOSPITAL GRADE) wall outlet equipped with a grounding terminal in
order to avoid an electric shock or fire in the event of a power leak.
• Insert a mains plug into a grounded outlet.
Breakdown of the instrument, power leaks, electric shock or fire may result.
• Securely connect the mains plug into an outlet.
Insecure connection may result in a fire.
2.6 After Use
CAUTION
• If the instrument will not be used for a long time, disconnect the power cord from the wall outlet.
This may cause fire.
• When the instrument is not in use, turn off the power switch and place a cover over
the instrument.
If the instrument is not covered, dust may affect measurement accuracy.
2.7 Maintenance and Checks
CAUTION
• Replace the fuses with the specified fuses only.
A fire may result.
• If disassembling is necessary to repair the instrument, be sure to ask your authorized
distributor for servicing.
• Never use an organic solvent such as paint thinner to wipe the exterior.
This may ruin the surface.

2 - 8
CAUTION
• When the instrument is sent back to NIDEK for repair or maintenance, wipe the surface
(specially, the area where the patient’s skin contacts) of the instrument with a clean cloth
immersed in ethyl alcohol for disinfection.
• Contact NIDEK or your authorized distributor to check whether the instrument needs
measurement accuracy calibration if the AR-measured results are largely different from
the subjective measurements.
2.8 Disposal
NOTE
• Follow local governing ordinances and recycling plans regarding disposal or recycling of
device components.
Especially the disposing method of lithium batteries varies according to the government.
As rechargeable lithium battery is used in the instrument, follow the local governing
ordinates and recycling plans when disposing a board with lithium batteries.
• When disposing packing, sort them by the materials and follow local governing ordinances
and recycling plans.

2 - 9
2.9 Labels
The following labels provide safety information about each part.
or
or
or

§3
CONFIGURATIONS
Power Switch
Printer
TV Monitor
Cover for Switches
Locking knob
IOL Button
Changing Button
Print Button
Memory Indicator
Joystick
Start Button
Measuring Unit Knob
If optionally ordered:
IC Card System
Display Panel

3 - 2
IC Card System (Optional)
If the optional IC card system has been or-
dered, the IC card Reader/Writer should have
been factory-built in this part.
TV Monitor
Displays the patient’s eye, Target, measure-
ment results, and Alignment light projected
on the patient’s eye.
The indicator of R (right) or L (left) shows
the measuring eye side as well as the eye side
of the measurement result on the display.
Display Panel
Displays measurement results. The indicator
of R (right) or L (left) shows the measuring
eye side as well as the eye side of the mea-
surement result on the display.
Cover for Switches
Inside, there are two switches for setting mea-
suring conditions, a switch for printing
“Eyeprint”, and also knobs for adjusting con-
trast and brightness of the TV monitor dis-
play.
Locking Knob
Used to fix the main body to the base unit.
To lock the main body, bring the main body
to the center of the base unit, and turn the knob
counterclockwise while pressing it down. To
temporarily lock the body at any position, turn
the knob clockwise.
Do not lock the main body with this locking
knob during transference. Otherwise, break-
down of the instrument may result.
IOL Button
Should be pressed to turn on IOL mode when
measuring an IOL-implanted eye or an eye
with a Contact Lens (CL) on. If such eye is
measured without turning on the IOL mode,
an error may appear and measurement may
not be completed. Also, used for system pa-
rameter and date & time settings.
Changing Button
Used to change between AR (refractive
power) measurement and PD (pupil distance)
measurement. Also, used to change system
parameter settings, date & time settings, and
character code of comments.
Print Button
Prints the measurement result if pressed after
measurement.
Memory Indicator
While the measurement result is in memory,
this will be illuminated. It goes out when the
result is printed out and the next measurement
is starting.
Joystick
Used to move the main body right, left, back
and forth.
Start Button
Used to start the AR (refractive power) mea-
surement or PD (pupil distance) measure-
ment. Also used to change the item number
of system parameters.
Measuring Unit Knob
Moves the measuring unit up and down by
turning this.

3 - 3
㧜
%;.㧙
CYL Mode
Changing Switch
Measuring Count
Indication
Auxiliary Switches
Contrast Control
Brightness Control
Setting Switch
Eyeprint Switch
Min. Pupil Mark
Target
Alignment Light
Cylinder Mode
Indication
Indications on the TV monitor during measurement

3 - 4
CYL Mode Changing Switch
Changes the cylinder mode, the reading di-
rection of cylinder data.
+ mode ....... Cylinder data will be indicated
by + reading.
- mode ........ Cylinder data will be indicated
by - reading.
MIX mode .. Cylinder data will be indicated
by + reading when the refractive
power is positive for any axis
angle. In other cases, cylinder
data will be indicated by - read-
ing.
• The cylinder mode can be changed even after
measurement.
• Data will be printed out with the mode status
at the time of printout.
Min. Pupil Mark
Indicates the minimum pupil size measurable.
The instrument may not perform measure-
ment when the measuring eye is smaller than
this mark or eyelash is on this mark.
Cylinder Mode Indication
Indicates the current cylinder mode.
Target
Used as a guide to place the patient’s eye in
the center of the TV monitor.
Alignment Light
Should be in focus and be placed in the target
at measurement.
Contrast Control
Used to adjust the contrast of the TV moni-
tor.
Brightness Control
Used to adjust the brightness of the TV moni-
tor.
Setting Switch
Used when setting system parameters, setting
date and time, and writing comments.
Eyeprint Switch
Prints only the basic results and an Eyeprint,
which graphically shows the refractive status
of the eye, by pressing it after measurement.
The eyeprint will be printed out regardless of
the settings in system parameter. Also, used
to select one of parameter setting modes or
date & time setting mode.