Nidek Medical TONOREF II User manual

OPERATOR’S MANUAL
OPERATOR’S MANUAL
AUTO REF/KERATO/TONOMETER
AUTO REF/KERATO/TONOMETER

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]
March 2015
15601-P902-J0
Printed in Japan
Original instructions
2007 NIDEK CO., LTD.
C

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Use this device properly and safely.
"CAUTION: Federal Law (US) restricts this device to sale by or on the order of a properly
licensed practitioner."
Safety precautions
BEFORE USE, READ THIS MANUAL.
This operator’s manual contains information necessary for the operation of the NIDEK
AUTO REF/KERATO/TONOMETER Model TONOREF II. This manual includes the
operating procedures, safety precautions, and specifications.
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 to verify use whenever necessary.
The device complies with ISO 10342 subclause 4: 2010 (Ophthalmic instruments-Eye
Refractometers) and ISO 8612: 2009 (Tonometer). The dioptric powers are indicated with
reference wavelength λd = 587.56 nm.
There are no parts within the device that requires servicing by the user other than printer
paper.
If you encounter any problems or have questions about the device, please contact NIDEK
or your authorized distributor.
In this manual, signal words are used to designate the degree or level of safety alerting. The defi-
nitions 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, 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.
15601-P902-J0

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Usage precautions
Safety of LED
Before Use
CAUTION
• The device is a Class 1 LED product in accordance with IEC60825-1: 1993+A1:
1997+A2: 2001 and the LED used for the device is safe in expected use conditions
including situations such as looking into the LED using an optical system. However, it
is recommended to observe the following precautions when using the device:
1)Do not direct LED beams to human eyes when unnecessary.
2)Do not look into the objective lens (aperture) for a long period of time for observation.
3)If the device cannot be used properly or any device problem cannot be solved, imme-
diately stop using the device, then contact NIDEK or your authorized distributor.
WARNING
• Connect the power plug to a ground outlet. Or connect a grounding wire to a ground
terminal.
Electric shock or fire may occur in the event of device malfunction or power leakage.
CAUTION
• Do not use the device for other than the intended purpose.
NIDEK is not responsible for accidents or malfunctions caused by misuse.
• Be sure to read the manual prior to operation of the device to understand the safety
precautions and operating procedures thoroughly. Use the components specified by
NIDEK.
Using the device for purposes other than specified in this manual may cause unex-
pected malfunctions and/or adverse events.
• Never modify nor touch the internal structure of the device.
Electric shock or malfunction may result.
• Install the device in an environment that meets the following conditions. The following
conditions must be maintained during use.
Use conditions
Temperature: 10 to 35°C (50 to 95°F)
Humidity: 30 to 90% (Non-condensing)
Pressure: 800 to 1060 hPa
A dust-free location
A place with little external light
A level and stable surface free from vibration and shock
If the device is not installed and used under the above conditions, the reliability of mea-
sured results is impaired, and malfunction may result. In addition, there is a possibility of
injury if the device receives shock and falls down.
• Avoid installing the device near sunny windows or directly under a light.
Intense light entering the measuring window may interfere with proper measurement.
• Install the device in a place that is not exposed to strong electromagnetic waves.

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CAUTION
• Install the device in an environment where no contaminants such as corrosive gas,
acid, or salt are contained in the air.
Corrosion or malfunction of the device may result.
• Avoid installing the device where it is exposed to direct air-conditioning flow.
Changes in temperature may result in condensation inside the device or adversely
affect measurements.
• 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 perform properly. Malfunc-
tion or fire may occur.
• Completely insert the power plug into the outlet as far as the prongs will go.
Fire may occur if the device is used with a loose connection.
• Never use a table tap or extension cable to supply the device with power.
The electrical safety may be lowered.
• Do not use a power cord other than the one supplied. Also do not connect the
supplied power cord to any other device.
Failure or fire may result.
• Do not place heavy objects on the power cord.
The damaged power cord may cause fire or electric shock.
• Before connecting cables to the device, turn the device off and disconnect the power
cord from the outlet.
Malfunction may result.
• Install the device in area where the outlet that the mains 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.
• Before carrying the device, put the device into the packing mode and lock the main
body to the base with the locking lever.
Accidental movement of the measuring unit during transportation may result in malfunc-
tion.
• When the device is carried, two persons
should hold (A) and (B) (both right and left
sides). Avoid holding the forehead rest
and the main body; hold the bottom of the
base.
If only one person carries the device, or
areas other than the base are held and
the device falls, there is a possibility of
injury or malfunction.
(A) (B)

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During Use
WARNING
• Before starting NT measurement, adjust the safety stopper for each patient to prevent
the air nozzle from touching the patient’s eye.
Contact between the air nozzle and the eye may damage the cornea.
CAUTION
• Before use, perform visual and operation checks. If abnormal conditions are
encountered, stop using the device.
If the device is used under abnormal conditions, intended results may not occur. Also
unexpected malfunctions or health hazards may occur due to improper measurement.
• Refrain from use on patients who have corneal surface disorder or anamnesis.
• Take extra care when measuring patients with acute keratoconjunctivitis or poor
fixation.
• Before measurement, explain the measurement purpose or method sufficiently to
patients.
ex) You will feel a puff of air on your eye. This is normal measurement and has no
effect on the eye.
• Be sure not to touch the patient’s face during alignment or when alternately
examinating the patient’s right and left eye.
• Be sure to connect an interface cable, checking the symbols of input (IN: ) and
output (OUT: ).
Data transmission may not be performed properly.
• Do not put hands or fingers near or under the moving parts (measuring unit, main
body, and chinrest). Pay particular attention to the measuring unit as it moves in each
direction during auto tracking. Be sure to give this caution to patients.
Hands or fingers may be pinched and may result in injury.
• Instruct the patient to fix on the fixation light with their eyes wide open. Start the
measurement after confirming that the instruction is properly followed by the patient.
Be careful not to perform the measurement while the device is misaligned to the
patient’s eye.
Proper measurement may not be performed.
ex) - Instruct the patient not to blink their eyes during the measurement. (The patient’s
blinking during the measurement can be prevented by having them blink just
before the measurement then open their eyes wide.)
- Instruct the patient to open both eyes during the measurement. (With one eye
closed, the fixation is not stable and the other eye cannot be opened wide
enough.)
• When measuring, caution patients not to touch the NT measurement part.
When switching from NT measurement to R/K measurement, the air nozzle recesses
and the shutter closes at which time fingers may be caught in the shutter. (In this case,
the cover stops immediately and does not result in injury.)
• After measurement, instruct the patient not to hold the chinrest when the patient is
released from the device.
The device may topple over resulting in injury.

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CAUTION
• Before or after use of the device, and before treating each patient, wipe the forehead
rest and chin rest with a clean cloth such as gauze dampened with rubbing alcohol.
If chinrest paper is used, remove one piece for each patient.
For severe stains, wipe the area not with a dry cloth but with gauze dampened with
alcohol.
• After use on the patients with an infection, be sure to clean the air nozzle with a cotton
swab dampened with rubbing alcohol.
Infected tears may be scattered and come into contact with the air nozzle then scat-
tered again, causing a secondary infection.
• Before and after use, check that there are no contaminations like dust or fingerprints
on the air nozzle or the measuring window.
The measurement accuracy may decrease substantially.
• In the event of smoke or strange odors, immediately turn off the device and
disconnect the power plug from the outlet. After you are sure that the smoke has
stopped, contact NIDEK or your authorized distributor.
Usage of the device under such abnormal conditions may cause fire or electric shock.
In case of fire, use a dry chemical (ABC) extinguisher to extinguish the fire.
• Immediately replace the power cord if the internal wires are exposed, the device turns
on or off when the power cord is moved, or the cord and/or plug are too hot to be held
with hands.
This may result in electric shock or fire.
In the event of malfunction, disconnect the power cord from the wall outlet. Never touch
the inside of the device and contact NIDEK or your authorized distributor.
• Never press the LCD display with a hard object such as a ball-point pen. Keep
magnetic objects away from the LCD display.
The device may be damaged.
• Do not operate the LCD display with wet hands.
Water seeping into the device may result in failure of the device.
• There may be a few constantly-lit, missing, or dead pixels in your LCD which are a
characteristic of the LCD manufacturing process. This does not represent failure of
the LCD; continuously use the display.
• When connecting the device to a PC* that does not correspond to IEC60601-1, be
sure to supply power through an isolation transformer.
*PC adopting a class II AC adapter corresponds to IEC60950-1.
Electric shock may occur. For installation of the isolation transformer, consult NIDEK or
your authorized distributor.

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CAUTION
• When connecting to peripheral equipment like a PC with LAN connector via a
medical facility network, insert or connect the isolation transformer between
medical electrical equipment and networked device (HUB etc.), or networked device
and other electrical equipment.
Depending on the types or numbers of other electrical equipment connected to the net-
work, electric shock or malfunction/failure of the electrical equipment may occur.
For installation of the network isolation transformer, consult NIDEK or your authorized
distributor.
• Accessory equipment connected to the analog and digital interfaces must be certified
according to the representative appropriate national standards (for example, UL
60950-1 for Data Processing Equipment, UL 60601-1 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 configures a medical system,
and is therefore responsible 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.
• 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.
• If the device is used after a long period of disuse, check for any abnormality before
use.
• In the event of malfunction, disconnect the power cord from the wall outlet. Do not
touch the inside of the device and contact NIDEK or your authorized distributor.
• This device is classified as Group 1 set by ISO 15004-2: 2007 Light Hazard and
conforms to the standard.

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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

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After Use
CAUTION
• This device uses a heat-sensitive printer paper. The paper degrades over time and the
printed characters may become illegible.
If glue containing organic solvents or adhesives such as on adhesive tape comes in
contact with the printer paper, the printed characters may become illegible.
To keep the printed data for a long period of time, make copies of the printouts or write
the measured results down.
• When the device is not in use, turn off the power switch and put the dust cover over
the device.
If not, dust may affect the measurement accuracy.
• Do not yank the power cord to disconnect it from a wall outlet but hold the plug.
This can damage the metal core of the cord and may result in fire, short circuit or elec-
tric shock.
• Occasionally clean the prongs of the main plug with a dry cloth.
If dust settles between the prongs, the dust will collect moisture, and short circuit or fire
may occur.
• If the device will not be used for a long time, disconnect the power cord from the wall
outlet.
Fire may occur.
• Maintain the surrounding temperature and humidity at the following ranges during
transportation and storage of the device.
Environmental conditions:
Temperature: –10 to 55ºC (14 to 131ºF)
Humidity: 10 to 95% (non-condensing)
Pressure: 700 to 1060 hPa
A place not exposed to the water
No large amount of dust is contained in the air
Level and stable surface without vibration and shock
A place not exposed to direct sunlight
No chemicals or organic solvents are present, or a place where no corrosive gas may
be generated
• To transport the device, use the special packing materials to protect from shock and
impact.
Excessive vibration or impact may cause device malfunction.
• When transporting, set the mode to Packing mode and pack the main body in the
original packing material with the fixing lever unlocked.
It may result in failure when excessive vibration and shock are applied.
For packing mode setting, see “2.3.2 Shutoff before transporting the device” (page 36).