Nidek Medical AR-600 User manual

NIDEK
AUTO REFRACTOMETER
Model AR-600
OPERATOR’S
MANUAL

NIDEK CO., LTD. : 34-14, Maehama, Hiroishi-cho, Gamagori, Aichi 443-0038, Japan
(Manufacturer) Telephone: [phone]
Facsimile: (0533) 67-6610
NIDEK CO., LTD : 6th Floor, Takahashi Bldg., No.2, 3-chome, Kanda-jinboucho
(Tokyo Office) Chiyoda-ku, Tokyo 101-0051, Japan
Telephone: [phone]
Facsimile: [phone]
Telex: 2226647 NIDEK J
NIDEK INCORPORATED : 47651 Westinghouse Drive, Fremont, California 94539, U. S. A.
(United States Agent) Telephone: [phone]
Facsimile: [phone]
NIDEK SOCIETE ANONYME : Europarc 13, rue Auguste Perret, 94042 CRETEIL, France
(Authorized Representative) Telephone: [phone]
Facsimile: (01) 49 80 32 08 2005. 1
32906-P902O
Printed in JAPAN

BEFORE USE OR MAINTENANCE, READ THIS MANUAL.
This Operator’s Manual contains information necessary for the operation of the NIDEK
AUTO REFRACTOMETER Model AR-600.
This manual includes the operating procedures, safety precautions, specifications, and
information about accessories and maintenance.
The device complies with ISO 10342 (Ophthalmic devices—Eye Refractometers). IEC
60601-1 and UL 60601-1 standards are applied in this manual. The dioptric powers are
indicated with a reference of wavelength λd = 587.56 nm. This manual is necessary for
proper use. Especially, the safety precautions and operating procedures must be
thoroughly understood prior to operation of the device. Keep this manual handy for
reference.
There are no user-serviceable parts inside the device except printer paper and fuses.
Therefore, if you encounter any problems or have questions about the device, please
contact NIDEK or your authorized distributor.
(This applies to products whose power source is 100/120 Vac.)
MEDICAL ELECTRICAL EQUIPMENT
34VK
UL60601-1
CAN/CSA C22.2 NO. 601.1
WITH RESPECT TO ELECTRICAL SHOCK, FIRE AND
MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH
UL6060l-1 AND CAN/CSA C22.2 NO. 601.1

Page
Table of Contents
§
1INTRODUCTION .........................................................................................................1-1
1.1Outline of the Product ............................................................................................... 1-1
1.2 Indications for Use ................................................................................................... 1-1
1.3 Classifications .......................................................................................................... 1-1
1.4 Symbol Information ................................................................................................. 1-2
§
2SAFETY..........................................................................................................................2-1
2.1 Operation..................................................................................................................2-1
2.2 Storage......................................................................................................................2-2
2.3 Transportation...........................................................................................................2-3
2.4 Installation ................................................................................................................2-3
2.5 Wiring.......................................................................................................................2-5
2.6 After Use ..................................................................................................................2-5
2.7 Maintenance and Checks..........................................................................................2-9
2.8 Disposal.................................................................................................................... 2-9
2.9 Labels ..................................................................................................................... 2-10
§
3CONFIGURATION.......................................................................................................3-1
§
4OPERATING PROCEDURES ....................................................................................4-1
4.1 Operation Flow.........................................................................................................4-1
4.2 Preparation for Measurement ................................................................................... 4-1
4.3 AR (refractive error) Measurement .......................................................................... 4-6
4.4 PD (Pupillary 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 Setup ............................................................................................................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 the Printer Paper...................................................................................... 8-1
8.2 Setting a Stack of Chinrest Paper ............................................................................. 8-3
8.3 Replacing Fuses........................................................................................................8-4
8.4 Cleaning the Measuring Window.............................................................................8-6
8.5 Cleaning the Exterior ...............................................................................................8-7
8.6 List of Replacement Parts ........................................................................................ 8-7
§
9IC CARD SYSTEM (OPTIONAL) ............................................................................9-1
§
10SPECIFICATIONS ....................................................................................................10-1
§
11ACCESSORIES.......................................................................................................... 11-1
11.1 Standard Accessories ............................................................................................ 11-1
11.2 Optional Accessories ............................................................................................ 11-1
§
12EMC (ELECTROMAGNETIC COMPATIBILITY) .............................................12-1
APPENDIX A. GLOSSARY .................................................................................................. A-1
INDEX ...........................................................................................................End of this manual

[This page is intentionally left blank.]

§1
INTRODUCTION
1.1 Outline of the Product
The NIDEK AR-600 is an auto refractometer which objectively measures refractive errors of
sphere, cylinder, and axis for the lens that corrects the patient’s vision into emmetropia. Weak
infrared rays are used for the measurement.
This device has a main body and a measuring unit integrated on one base. On the base are a chin
rest on the patient’s side and a printer on the operator’s side which outputs measured results. On
the main body is a TV monitor, a control panel, and a joystick, which are used to make alignment
and perform operations. The measuring unit has a measuring window into which the patient
looks and where the infrared ray radiates on the patient’s eye.
1.2 Indications for Use
The Model AR-600 Auto Refractometer is a diagnostic device that is indicated for use in the
automated measurement of refractive errors of the eye.
1.3 Classifications
[Form of protection against electric shock] Class I
The AR-600 is classified as a Class I device.
A Class I is a device in which the protection against electric shock does not rely on basic
insulation only, but which includes an additional safety precaution in such a way that means
are provided for the connection of the device to the protective (ground) conductor in the fixed
wiring of the installation in such a way that accessible metal parts cannot become live in the
event of a failure in the basic insulation.
Use a power outlet which is equipped with a grounding terminal.
[Degree of protection against electric shock] Type BApplied Part
The AR-600 is classified as a device with a Type BApplied Part.
A Type B Applied Part provides a particular degree of protection against electric shock,
particularly regarding the following:
- allowable leakage currents
- reliability of the protective earth connection (if present)
[Degree of protection against ingress of liquids] IP 20
The AR-600 is classified as IP20*1.
TheAR-600 is an ordinary device, as such does not provide protection with respect to harmful
effects due to the ingress of water although it is protected against access to hazardous parts
with a solid matter such as a finger of 12.5 mm in diameter.
Avoid exposing water to the device.
*1 In accordance with IEC 60529

1 - 2
[Degree of protection against flammability]
The AR-600 is classified as a device not suitable to be used in a potentially flammable
environment.
Do not use near flammable materials.
[Method(s) of sterilization or disinfection recommended by the manufacturer]
The forehead rest and chinrest should be wiped using a cloth dampened with alcohol as
necessary.
[Mode of operation]
Classification of theAR-600: continuous operation
1.4 Symbol Information
This symbol indicates that important descriptions are contained in the operator’s manual
and that the operator must refer to the operator’s manual prior to operation or maintenance.
This symbol indicates that the degree of protection against electric shock is of a Type B
Applied Part.
This symbol of the power switch indicates that when the switch is pressed to this symbol
side, power is supplied to the device.
This symbol of the power switch indicates that when the switch is pressed to this symbol
side, power is not supplied to the device.
This symbol indicates the fuse rating.
This symbol indicates the input port.
This symbol indicates the output port.
This indicates that the device must be supplied only with alternating current.
This indicates the knob for adjusting the contrast.
This indicates the knob for adjusting the brightness.

§2
SAFETY
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 Operation
CAUTION
• Never disassemble nor touch the inside of the device.
This may result in electric shock or device malfunction.
• Do not hold the power cord, but hold the mains plug to disconnect it from an outlet.
A break in the internal wiring of the cord may result in short circuit or electric shock.
• Never put a heavy object on the power cord nor catch the cord between any objects.
The cover of the cord may become worn and may cause fire or electric shock.
• If the metal core of the power cord is exposed, power turns on and off by shaking the cord,
or the cord/plug gets so heated that one cannot hold it, it means that the cord is damaged.
Exchange the cord immediately.
This may cause electric shock or fire.
• Do not use the device for other than the intended purpose.
NIDEK will not be responsible for accidents or malfunctions caused by such carelessness.
• Wipe between the prongs of the mains plug with a dry cloth every once in a while.
If dust settles between the prongs, the dust easily takes up moisture, and it may cause
short circuit and fire.
• The measured values of objective refractive power obtained by theAR-600 are intended
to be used as a reference for 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 measurement of each patient, wipe the forehead rest and chinrest with a
clean cloth. Moreover, remove one piece of chinrest paper for each patient if a stack of
the chinrest paper is fixed to the chinrest. If necessary, wipe the forehead rest and chinrest
using a cloth dampened with rubbing alcohol.
• In the event a failure occurs in the device, do not touch the inside of the device, but
remove the power cord from the outlet and contact your authorized distributor.
• Keep fingerprints and dust off of the measuring window.
The measurement accuracy may deteriorate substantially.
• In advance of a measurement of each patient, wipe the forehead rest and chinrest with a
clean cloth. Moreover, remove one chinrest paper for each patient if a bunch of the
chinrest paper is fixed to the chinrest. If necessary, wipe the forehead rest and chinrest
using a cloth dampened with rubbing alcohol.
• In the event a failure occurs in the device, do not touch the inside of the device, but
remove the power cord from the outlet and contact your authorized distributor.
• Keep fingerprints and dust off of the measuring window.
The measurement accuracy may deteriorate substantially.
2.2 Storage
CAUTION
• Do not store the device in a place where it may get wet or where poisonous gas or liquid
is stored.
• Avoid storing the device in an area with excessive heat, humidity, or dust.
To preserve the appearance and internal parts of the device, avoid direct exposure to
sunlight.

2 - 3
2.3 Transportation
CAUTION
• Do not drag the device by its cord or cable.
This may cause injury or device damage.
• To carry the device, hold it from the side with both your hands on its base. (Do not ever
hold the forehead rest to lift up the device.)
This may result in injury or device damage.
• To transport the device to another location, store the device in a shipping carton or the
optional carrying case. In such cases, never lock the main body with the locking knob.
Breakdown of the device may result.
2.4 Installation
CAUTION
• Before connecting the power cord or interface cable, provide a stable, level, and open
space.
Since receptacles are under the base unit, the device may fall and may cause injury or
device malfunction.
• Do not install the device near water.
If water gets into the internal structure, there is the possibility of electric shock or device
malfunction.
• Install the device in a stable and level place where vibration or shock does not occur.
The device may not perform measurement correctly or may malfunction. Also, if the
device falls because of any accidental shock, it may result in injury.
• Install the device in the following conditions.
A dust free environment
A light interference free environment
A vibration and shock free environment
• Install the device in a place where temperature and humidity can be maintained under the
following conditions.
Temperature: 10 - 40ºC
Humidity: 30 - 75% (non-condensing)

2 - 4
CAUTION
• This device 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 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 of the following measures:
- Reorient or relocate the receiving device
- Increase the separation between the device.
- Connect 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 help.
• 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. TheAR-
600 complies with these requirements as tabled on pages 12-1 to 12-3. Follow the guidance
in the tables for use of the device in an electromagnetic environment.

2 - 5
2.5 Wiring
CAUTION
• Be sure to use a power outlet which meets the power specification requirements.
If the line voltage is too high or too low, the device may not give full performance.
Malfunction or fire may also occur.
• Be sure to use a (HOSPITAL GRADE) wall outlet equipped with a grounding terminal in
order to avoid electric shock or fire in the event of power leakage.
• Insert the mains plug into a grounded outlet.
Breakdown of the device, power leakage, electric shock or fire may result.
• Securely connect the mains plug into an outlet.
Insecure connection may result in fire.
2.6After Use
CAUTION
• If the device will not be used for a long time, disconnect the power cord from the wall
outlet.
This may cause fire.
• When the device is not in use, turn off the power switch and place a cover over the device.
If the device is not covered, dust may accumulate and affect measurement accuracy.

2 - 6
CAUTION
• 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 device gives a measure of hazard potential when
the device is operated at maximum intensity and maximum aperture. The values of LA
or LBfor 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 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 AR-600. Patients will
be at low risk of acute optical radiation with theAR-600. 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.

2 - 7
LA (µW/cm2/sr) 380 - 700 nm 1.158
LB (
µ
W/cm2/sr) 305 - 700 nm 0.106
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 during AR measurement (maximum light intensity)
Spectrum irradiance
*1LA: Spectrally weighted photochemical aphakic source radiance
*2LB: Spectrally weighted photochemical phakic source radiance

2 - 8
{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 - 9
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 device, 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.
• When the device is sent back to NIDEK for repair or maintenance, wipe the surface
(especially the area where the patient’s skin contacts) 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
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.
The device contains the circuit board with the lithium battery. Because the disposal
method of lithium batteries varies according to the government, follow the local
governing ordinates and recycling plans when disposing of the circuit board with the
lithium battery.
• When disposing of packing materials, sort them by material and follow local governing
ordinances and recycling plans.

2 - 10
2.9 Labels
The following labels provide safety information about each part.
or
or
or
(Only marketed for NIDEK INCORPORATED)

2 - 11

§3
CONFIGURATION
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