Nidek Medical RT-3100 User manual

REFRACTOR
REFRACTOR
RT-3100
RT-3100
OPERATOR’S MANUAL
OPERATOR’S MANUAL

NIDEK CO., LTD. : 34-14, Maehama, Hiroishi-cho, Gamagori, Aichi 443-0038, Japan
(Manufacturer) Telephone: [phone]
Facsimile: [phone]
NIDEK CO., LTD : 3F Sumitomo Fudosan Hongo Bldg., 3-22-5, Hongo,
(Tokyo Office) Bunkyo-Ku, Tokyo 113-0033, Japan
Telephone: [phone]
Facsimile: [phone]
NIDEK INCORPORATED : 47651 Westinghouse Drive, Fremont, California 94539, U. S. A.
(United States Agent) Telephone: [phone]
Facsimile: [phone]
NIDEK S.A. : Europarc 13, rue Auguste Perret, 94042 Créteil, France
(EU Authorized Representative) Telephone: [phone]
Facsimile: [phone]
August 2012
34090-P902E
Printed in Japan
Original instructions

I
Use this device properly and safely.
Safety precautions
BEFORE USE, READ THIS MANUAL.
This operator’s manual includes operating procedures, safety precautions, and
specifications for the NIDEK REFRACTOR RT-3100 when it is used in combination with
any of the NIDEK chart presenting devices*1. The dioptric powers are indicated with a
reference wavelength of 546.07 nm.
The safety cautions and operating procedures must be thoroughly understood before
using the device.
Keep this manual handy for verification.
If you encounter any problems or have questions about the device, please contact NIDEK
or your authorized distributor.
*1 Connectable chart presenting devices
• Space saving chart SSC-300, SSC-330, SSC-350, SSC-370
• Chart projector CP-670, CP-690, CP-770
• System chart SC-1700 Pola, SC-2000, SC-1600, SC-1600 Pola
*2 For simplicity, examples of chart type used in this manual are for the CP-770M only.
These examples are applicable to any other type unless specified otherwise.
*3 This manual indicates the visual acuity by fractions (feet). Refer to “7.2 VA Conversion
Table” (Page 121) for visual acuity represented by decimals (meters).
In this manual, signal words are used to designate the degree or level of safety alerting. The defini-
tions are as follows.
WARNING •Indicates a potentially hazardous situation which, if not avoided, could result in
death or serious injury.
CAUTION •Indicates a potentially hazardous situation which, if not avoided, might result in
minor or moderate injury or property damage.
Even situations indicated by CAUTION might result in serious injury under certain conditions.
Safety precautions must be strictly followed at all times.

II
Usage precautions
Before Use
WARNING
•Be sure to secure the refractor head to the refractor arm.
If the refractor head is dropped or falls, injury or device failure may result.
•Connect the power plug to a grounded outlet.
Electric shock or fire may result in the event of malfunction or power leakage.
•Do not modify or touch the device. Do not touch anything inside the device.
This may result in electric shock or malfunction.
CAUTION
•The safety precautions and operating procedures must be thoroughly
understood before using the device.
Unintended use may cause unexpected malfunction or adverse experience.
•Do not store the device in an area that is exposed to rain or water, or
contains poisonous gas or liquid.
•Do not store the device in dusty, hot, humid places or in direct sunlight.
•When connections between units are removed for moving the device, and
necessary to reconnect the units, contact NIDEK or your authorized
distributor.
•Do not carry the device with the power cable and communication cable
connected.
If the device falls, injury or device failure may result.
•Install the device on a stable and level surface.
If the device falls, injury or device failure may result.
•Never install the device in a place where it is exposed to water.
Contact with liquids may cause electric shock or device failure.
•Install the device in an environment that meets the following conditions.
The following conditions must be maintained during use.
Temperature: 10 to 35ºC (50 to 95ºF)
Humidity: 30 to 85% (No condensation)
Pressure: 800 to 1060 hPa
Installation place: Interior
No hazardous dust or smoke
A dust-free place
A place with little external light
A place free from vibration and shock
•Be sure to level the refractor head before use.
Failure to do so could affect the data accuracy. Level the refractor head by turning the
leveling adjustment knob until the bubble is centered in the level.

III
•Be sure to use a wall outlet which meets the power specification
requirements.
If the line voltage is too high or too low, the device may not operate properly. Malfunc-
tion or fire may result.
•Do not overload the electrical outlet.
Fire may result.
•Fully insert the power plug into the outlet.
Imperfect connection may cause fire.
•Never use a power strip or extension cable to supply the device with power.
The electrical safety may be lowered.
•Do not use any power cord other than that equipped. Do not use the
equipped power cord for purpose other than as intended.
Malfunction or fire may result.
•Install the device in area where the outlet that the power plug is inserted
into is easily accessible during use. In addition, ensure that the power cord
can be disconnected without the use of a tool.
Otherwise, it may interfere with disconnecting of the power from the input power
source in case of abnormality.
•Do not place heavy objects on the power cord.
A damaged power cord may cause fire or electric shock.
•This device has been tested and found to comply with the limits for medical
devices according to IEC 60601-1-2: 2007.
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 separation between the devices.
Connect the device to 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.
•The International Electrotechnical Commission sets the essential
requirements for electrical and electronic equipment that may disturb, or be
disturbed by, other equipment. The RT-3100 complies with these
requirements as tabled on Pages 123 to 126. Follow the guidance in the
tables for use of the device in an electromagnetic environment.

IV
During Use
WARNING
•When moving the refractor head, make sure that there are no obstacles in
its path.
If the arm is swung carelessly, it may bump against someone or something and injury
or malfunction may occur.
CAUTION
•When installing and operating the device, observe the following
instructions about EMC (electromagnetic compatibility):
- Do not use the device simultaneously with other electronic equipment to avoid elec-
tromagnetic interference with the operation of the device.
- Do not use the device near, on, or under other electronic equipment to avoid elec-
tromagnetic 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.
•Unplug the power cord and contact NIDEK or your authorized distributor if
the internal wires are exposed, the table turns on or off when the power
cord is moved, or the cord and/or plug are too hot to hold.
This may result in electric shock or fire.
•Keep the measuring windows free of fingerprints and smudges.
Failure to do so could affect the data accuracy.
•In the event of smoke or strange odors, immediately turn off the device and
disconnect the power plug from the outlet. After you are positive that the
smoke has stopped, contact NIDEK or your authorized distributor.
Continued use of the device under such abnormal conditions may cause fire or elec-
tric shock.
•When the device is not in use, turn it off and put the dust cover over it.
If the device is not covered for an extended period, the accumulation of dust may
affect the data accuracy.
•Do not touch the touch-screen panel with anything other than the tip of a
touch-screen pen.
Contact with a hard or sharp object such as a ball point pen may scratch the panel.
In addition, although the tip of a touch-screen pen is covered with resin which is
unlikely to scratch the panel, the panel may be scratched by strongly pressing the pen
against the panel.
Do not touch the panel with fingers. Doing so could decrease the panel sensitivity or
make the panel dirty. It may affect the near vision test accuracy.

V
•Perform the visual and operation checks before using the device. If any
abnormality is found, do not use the device.
Continued use of the device under such abnormal conditions may affect the data
accuracy. Unexpected malfunction or faulty diagnosis may induce unexpected health
hazards.
•Before each patient, always clean the patient's contact area (forehead rest
and face shields) using disinfectant alcohol.
•If the device fails, disconnect the power cord from the power outlet, then
contact NIDEK or your authorized distributor without touching the interior
of the device.
•Take care not to catch hands or fingers in moving parts.
•When connecting interface devices to the device, confirm the symbols, then
connect them securely without applying unnecessarily great force.
Terminals or cables may become damaged.
•Be sure to use only the printer paper (80620-00001) specified by NIDEK.
Other printer papers may cause improper printing and make the data unreadable.
•Do not apply adhesive tape to the printed paper.
Printed characters may fade.

VI
{Patient environment
The patient environment is the volume of space in which contact can occur between the patient and
any part of the device (including connected devices) or between the patient and any other person(s)
touching the device (including connected devices).
Use devices that comply with IEC60601-1 in the patient environment. If any device that does not com-
ply with IEC 60601-1 is to be used, use an isolating transformer or common protective grounding.
Radius of 1.5 m
1.5 m 1.5 m
2.5 m
[Example of patient environment]

VII
After Use
CAUTION
•If the device will not be used for the extended period, disconnect the power
cable from the wall outlet.
Settled dust may collect moisture, and short circuit or fire may result.
•Occasionally clean the prongs of the power plug with a dry cloth.
If dust settles between the prongs, it may collect moisture, and short circuit or fire may
result.
•Do not yank the power cord to disconnect it from an outlet.
This can damage the metal core of the cord and may result in electric shock, short cir-
cuit or fire.
•Before carrying the device to another location, disconnect all the cords and
cables.
Maintenance
CAUTION
•Only NIDEK service representatives or hospital personnel trained by NIDEK
should attempt to modify or touch the inside of the device and/or upgrade
the software.
NIDEK is not responsible for any accidents resulted from improper servicing.
•When performing maintenance work, secure sufficient maintenance space.
Maintenance work in an insufficient space may result in injury.
•When the device is sent back to NIDEK for repair or maintenance, wipe the
surfaces (especially, the area where patients contact) of the device with a
clean cloth dampened with ethyl alcohol for disinfection.
•Never use organic solvents such as a paint thinner to clean the exterior of
the device.
It may ruin the surface of the device.
•When cleaning the measuring window, be sure to remove any dust with a
blower brush and wipe lightly with a soft cloth.
Wiping the window without removing dust may scratch the lens coating and impair
measurement of the power or visual acuity.
•The manager of this device must perform maintenance and check every six
month.
For details of the maintenance and check, contact NIDEK.
When the maintenance check cannot be performed oneself, NIDEK can accept the
maintenance check.
•A pixel may be occasionally missing on the screen or a red, blue,or green pixel point may
always be displayed.
This does not represent a failure of the touch-screen panel; This is due to the manufacturing pro-
cess of the liquid crystal display.

VIII
Disposal
CAUTION
•Follow the local ordinances and recycling regulations regarding disposal
or recycling of the components. The device contains the circuit board with
a lithium battery mounted. Because the disposal method of lithium
batteries varies according to the local government, follow the local
governing ordinates and recycling plans when disposing of the circuit
board with the lithium battery.
It is recommended to commission the disposal to a designated industrial waste dis-
posal contractor. Inappropriate disposal may contaminate the environment.
•When disposing of packing materials, sort them by material and follow
local ordinances and recycling regulations.
Inappropriate disposal may contaminate the environment.