INSTRUCTION MANUAL
AUTO KERATO-REFRACTO TONOMETER
TRK-2P
INTRODUCTION
0123
Thank you for purchasing the TOPCON Auto Kerato-refracto tonometer TRK-2P.
INTENDED USE / INDICATIONS FOR USE
This instrument is used to measure refractive power of eyeball, radius of cornea curvature,
cornea thickness and intraocular pressure..
FEATURES
This instrument features the following:
• The position of the touch panel can be adjusted to accommodate the user's preferred position.
• Softer air puff for measuring intraocular pressure.
• Auto alignment function enables quick easy measurement under optimal conditions.
PURPOSE OF THIS MANUAL
To get the best use of the instrument, read GENERAL SAFETY INFORMATION and DISPLAYS AND SYMBOLS
FOR SAFE USE.
Keep this Manual at hand for future reference.
IPA Font License
Since this product partly uses a program derived from IPA Font, using the product is regarded as consent to the
IPA Font License Agreement v1.0.
For the IPA Font License Agreement v1.0, visit the following URL:
http://ipafont.ipa.go.jp/ipa_font_license_v1.html
1.No part of this manual may be copied or reprinted, in whole or in part, without prior written permission.
2.The contents of this manual are subject to change without prior notice and without legal obligation.
3.The contents of this manual are correct to the best of our knowledge. Please inform us of any ambiguous or
erroneous descriptions, missing information, etc.
4.Original Instructions
This manual was originally written in English.
©2013 TOPCON CORPORATION
ALL RIGHTS RESERVED
1
GENERAL SAFETY INFORMATION
CONTRAINDICATIONS • PROHIBITION
Ensuring the Safety of Patients and Operators
To prevent corneal damage, do not measure a patient with corneal disease or one who's had corneal
surgery.
To prevent corneal damage, do not measure a patient's wearing a contact lens.
Tell the patient to remove the contact lens.
WARNINGS
Ensuring the Safety of Patients and Operators
When operating the instrument, do not touch the patient's eye or nose.
Preventing Electric Shocks and Fires
To avoid fire and electric shock, install the instrument in a dry place free of water and other liquids.
To avoid fire and electric shock, do not put cups or other containers with liquids near the instrument.
To avoid electric shocks, do not insert metal objects into the instrument body through the vent holes or gaps.
To avoid fire in the event of an instrument malfunction, immediately turn OFF the power switch " " and
disconnect the power plug from the outlet if you see smoke coming from the instrument, etc. Don't install the
instrument where it is difficult to disconnect the power plug from the outlet. Ask your dealer for service.
2
CAUTIONS
Important caution
The following patients need to apply carefully.
• The patient of infectious disease, such as Keratoconjunctivitis epidemica.
Ensuring the Safety of Patients and Operators
To avoid injury when operating the up/down button for chinrest, be careful not to catch the patient's fingers.
The light emitted from this instrument involves potential risk; the longer the irradiation time, the more risk of
damage to the eye.
When the instrument operates with the maximum light volume, exposure for more than 2 hours will exceed
the safety guideline.
During alignment operation, please pay attention so that a patient's face does not move.
If the face moves, there is a danger that the main body will touch the patient's face..
Preventing Electric Shocks and Fires
To avoid injury by electric shock, do not open the cover. For repair, call your service engineer.
To avoid injury by electric shock when changing the fuse, turn off the power and pull out the power cable.
Use the rated fuse.
Electromagnetic Compatibility (EMC)
This instrument has been tested (with 100/120/230V) and found to comply with IEC60601-1-2:Ed.3.0:2007.
This instrument radiates radio frequency energy within standard and may affect other devices in the vicinity.
If you have discovered that turning on/off the instrument affects other devices, we recommend you change
its position, keep a proper distance from other devices, or plug it into a different outlet. Please consult your
authorized dealer if you have any additional questions.
3
DISPLAYS AND SYMBOLS FOR SAFE USE
To encourage safe and proper use and to prevent danger to the operator and others or potential damage to property,
warnings and cautions are placed on the instrument body and inserted in the instruction manual.
We suggest that everyone understand the meaning of the following displays, icons, and text before reading the
"GENERAL SAFETY INFORMATION" and observe all listed instructions.
DISPLAYS
Display Meaning
WARNINGS
CAUTIONS
NOTES
A WARNING is provided to alert the user to potential serious outcomes
(death, injury, or serious adverse events) to the patient or the user.
A CAUTION is provided to alert the user to use special care necessary for
the safe and effective use of the device. They may include actions to be
taken to avoid effects on patients or users that may not be potentially life
threatening or result in serious injury, but about which the user should be
aware. Cautions are also provided to alert the user to adverse effects on
this device of use or misuse and the care necessary to avoid such effects.
A NOTE is provided when additional general information is applicable.
SYMBOLS
Symbol IEC/ISO Publication Description Description (French)
IEC 60417-5032 Alternating Current Courant alternatif
IEC 60417-5008
IEC 60417-5007
Off (power: disconnection
from the main power
supply)
On (power: connection to
the main power supply)
Éteint (courant: coupure
avec le secteur)
Allumé (courant:
raccordement sur le
secteur)
IEC 60878-02-02 Type B applied part Partie appliquée du Type B
ISO 7010-W001 General warning sign
ISO 7010-M002
ISO 7000-2497 Date of manufacture Date de fabrication
ISO 7000-2498 Serial number Numéro de série
Refer to instruction
manual/booklet
Symbole d'avertissement
général
Voir le manuel/la brochure
4
POSITIONS OF WARNING AND CAUTION INDICATIONS
3 1 5
4
2
To secure safety, this equipment provides warnings.
Correctly use the equipment following these warning instructions. If any of the following marking labels are missing,
please contact your dealer or TOPCON at the address stated on the back cover.
No. Label Meaning
WARNING
1
2
3
4
5
To avoid injury caused by electric shock, do not open the cover.
Ask your dealer for service.
WARNING
Electric shock may cause burns or a possible fire. Turn the power switch
OFF and unplug the power cord before replacing the fuses. Replace only
with fuses of the correct rating.
CAUTION
Be careful not to hit the patient's eyes or nose with the instrument during
operation.
The patient may be injured.
CAUTION
When operating the chinrest up/down switch, be careful not to pinch the
patient's hand.
The patient may be injured.
Degree of protection against electric shock:
TYPE B APPLIED PART
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MAINTENANCE
User maintenance items
Item Inspection time Contents
Inspection Before using
Cleaning When the part is stained
Replacement As required
• The instrument works properly.
• The objective lens must be free of
stains and/or flaws.
• Confirm whether the foreign object is
attached to the measuring nozzle and
the area around the measuring nozzle.
• Air check
• Confirm that the safety stopper setting
and measuring nozzle do not move to
the patient's side beyond the safety
stopper setting position.
• Objective lens
• External cover, control panel, etc.
• Fuse
• Printer form
Manufacturer maintenance items
Item Checking time Contents
Cleaning each
component
Operation check Within 12 months
Accuracy check Within 12 months
Within 12 months
• Cleaning outer covers
• Checking the optical system
• Cleaning POWER unit
• Checking the main body operation
• Checking switches
• Confirming the ocular pressure measurement functions (using special tools)
• Confirming the cornea thickness measurement functions (using special tools)
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SPECIFICATIONS & PERFORMANCE
SPECIFICATIONS AND PERFORMANCE
REF measurement
Measurement Range Spherical refractive power: -30 to +25D (Display unit: 0.12D/0.25D steps)
Cylindrical refractive power:0D to ±12D (Display unit: 0.12D/0.25D steps)
Direction of astigmatic axis:0° to 180° (Display unit: 1°/5° steps)
(where, spherical refractive power + cylindrical refractive power +25D, or
spherical refractive power + cylindrical refractive power -30D)
Measured minimum
pupil diameter
PD measurement
range
Target fixation Auto fog system
KRT measurement
Measurement Range Cornea curvature radius: 5.00mm to 13.00mm (Display unit: 0.01mm)
Ocular pressure measurement
Measuring range 1 to 60mmHg
Measuring range 1 to 30/1 to 60mmHg , 2 step display
Cornea thickness measurement
Measuring range 0.4 to 0.75mm (Display unit: 0.001mm step display)
Others
2.0mm
20 to 85mm (1mm steps)
Corneal refractive power: 67.50D to 25.96D (Display unit: 0.12D/0.25D
steps)
(where, corneal refractive power =1.3375)
Corneal astigmatic power: 0D to ±12D (Display unit: 0.12D/0.25D steps)
Direction of corneal astigmatic axis: 0 to 180° (Display unit: 1°/5° steps)
(Display unit: 1mmHg step display, Average value: 1mmHg/0.1mmHg step
display)
Measuring head
travel distance
Chinrest travel
distance
External I/O
terminal
Forward/backward: 69.72mm
Left/right: 90mm
up/down: 96.56mm
up/down: 67mm
Input: RS232C
Output RS232C, USB
• For product improvements, the specification and appearance are sub-
ject to change without prior notice.
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GENERAL INFORMATION ON USAGE AND MAINTENANCE
INTENDED PATIENT POPULATION
The patient who undergoes an examination by this instrument must maintain concentration for a few minutes
and keep to the following instructions:
• To fix the face to the chinrest, forehead rest.
• To keep the eye open.
• To understand and follow instructions when undergoing an examination.
INTENDED USER PROFILE
Since the Auto Kerato-refracto tonometer TRK-2P is a medical device, the operation should be supervised by a
physician.
ENVIRONMENTAL CONDITIONS FOR USE
Temperature: 10°C to 40°C
Humidity: 30% to 90% RH (without condensation)
Atmospheric pressure:700hPa to 1060hPa
STORAGE, USAGE PERIOD
1. Environmental conditions (without package)
*Temperature : 10°C to 40°C
Humidity : 10% to 95% (without condensation)
Air pressure : 700hPa to 1060hPa
* THIS INSTRUMENT DOES NOT MEET THE TEMPERATURE REQUIREMENTS OF ISO 15004-1 FOR
STORAGE. DO NOT STORE THIS INSTRUMENT IN CONDITIONS WHERE THE TEMPERATURE
MAY RISE ABOVE 40°C OR FALL BELOW 10°C .
2. When storing the instrument, ensure that the following conditions are met:
(1) The instrument must not be splashed with water.
(2) Store the instrument away from environments where air pressure, temperature, humidity, ventilation,
sunlight, dust, salty/sulfurous air, etc. could cause damage.
(3) Do not store or transport the instrument on a slanted or uneven surface or in an area where it is subject
to vibrations or instability.
(4) Do not store the instrument where chemicals are stored or gas is generated.
3. Normal life span of the instrument:
8 years from delivery providing regular maintenance is performed [TOPCON data]
ENVIRONMENTAL CONDITIONS FOR PACKAGING IN STORAGE
(Product in its normal transport and storage container as provided by manufacturer)
Temperature : -20°C to +50°C
Humidity : 10% to 95%
ENVIRONMENTAL CONDITIONS FOR PACKAGING IN TRANSPORTATION
(Product in its normal transport and storage container as provided by manufacturer)
Temperature : -40°C to 70°C
Humidity : 10% to 95%
ELECTRIC RATING
Source voltage: 100-240V AC, 50-60Hz
Power input : 100VA
DIMENSIONS AND WEIGHT
Dimensions : 293~396mm(W) x 505~601mm(D) x 470~682mm(H)
Weight : 22.0kg
8
OPERATION PRINCIPLE
REF measurement:
The instrument projects a near infrared light to retina and the reflected image is received by a CCD camera, and
the spherical refractive power, cylindrical refractive power and the axis of astigmatism that are required for the
correction lens for making a patient's eye stigmatism, are determined through computation.
KRT measurement:
The instrument performs corneal curvature radius measurements through computation by projecting a keratoring to the cornea and receiving the reflected image by a CCD camera from the cornea surface, and by the corneal curvature radius computes the corneal refractive power, corneal astigmatic power, and corneal astigmatic
axis angle.
Ocular Pressure Measurement:
By ejecting air from the measuring nozzle to the cornea, detect by a pressure sensor the internal cylinder pressure required for the cornea to reach a prescribed deformed state (with a certain plane area), and calculate the
ocular pressure value by computing.
Cornea Thickness Measurement:
The slit light is projected onto the patient cornea at a slant, and the corneal thickness is measured by processing
the reflected light, which is received by a sensor, from the corneal surface and the corneal back.
9
DISPOSAL
This symbol is applicable for EU member countries only.
To avoid potential damage to the environment and possibly human
health, this instrument should be disposed of (i) for EU member
countries - in accordance with WEEE (Directive on Waste Electrical
and Electronic Equipment), or (ii) for all other countries, in accordance with local disposal and recycling laws.
• When disposing of the instrument and/or parts, follow local regulations for disposal and recycling.
NOTES
10
USAGE PURPOSE, FUNCTION AND EFFECTS
Use to measure the degree of eyeball refraction, curvature radius, corneal thickness and intraocular pressure.
OPERATING AND USAGE METHOD
Usage method
1 Connect the power supply cord to a commercial power source.
2 If using externally connected devices, connect them and turn ON the power sources.
3 Turn ON the power switch.
4 Check for dirt on the measuring window or measuring nozzle. Clean as necessary.
5 Enter patient and examiner information as required.
6 Select the measurement mode
7 Instruct the patient to place his or her chin on the chin-rest and forehead against the forehead rest.
8 Push the chin-rest up/down switch on the control panel to adjust the height of the chin-rest so that the
patient's eyes are in line with the height mark on the chin-rest.
9 Advise the patient to look straight at the internal fixation target in front of him or her. (The following
instructions are for REF/KRT and TONO/PACHO continuous measurement mode)
10 When the pupil image of the patient's eye displayed on the control panel
3)
ically adjusted
If both eyes are to be measured, the main unit automatically moves to the other eye after measurement
of one eye is complete, adjusts position and measures.
, the REF/KRT measurement is conducted, and the results are displayed on the joystick.
11 When the REF/KRT measurement is complete, the main unit automatically moves down and the mea-
surement nozzle moves to the front of the patient's eye.
12 The position is automatically adjusted, the intraocular pressure and corneal thickness measurements are
conducted, and the measurement results are displayed on the joystick. If both eyes are to be measured,
the main unit automatically moves to the other eye after measurement of one eye is complete, adjusts
position and measures.
13 When all measurements are complete, the measurement results are automatically printed.
1)
and eye to measure (left eye, right eye, both eyes) as required.
1)
2)
is tapped, position is automat-
4)
14 Turn OFF the power supply switch.
15 Turn OFF the power sources of any externally connected devices used.
16 Remove the power cord from the commercial power source.
1)
REF/KRT or TONO/PACHO continuous measurement modes (all ref measurement, kerato
measurement, intraocular pressure test and cornea thickness measurements), REF/KRT
measurement mode (ref measurement, kerato measurement), TONO/PACHO measurement mode
(intraocular pressure test and cornea thickness measurements), ref measurement, kerato
measurement, intraocular pressure test and cornea thickness measurements can be switched.
2)
Tapping refers to pressing the software button displayed on the joystick.
3)
Operate the joystick to manually adjust a position or conduct a measurement.
4)
If not printing measurement results or tapping the printout button on the joystick, data can be output in
a printout of measurement results and /or outputting data to a connected PC or other externally
connected device.
See "PREPARATIONS", "BASIC OPERATIONS" and "OPTIONAL OPERATIONS" in the "User Manual"
for more information.
Please refer to the User Manual.
11
Please provide the following information when contacting us regarding questions
about this instrument:
• Machine type:: TRK-2P
• Manufacturing No: Marked on the rating nameplate.
• Period of use: Please inform us of the date of purchase.
• Defective condition: Please provide us with as much detail as possible.
AUTO KERATO-REFRACTO TONOMETER TRK-2P
INSTRUCTION MANUAL
2013 version (2013.11-100TH )
Date of issue:November 8, 2013
Published by TOPCON CORPORATION
75-1 Hasunuma-cho, Itabashi-ku, Tokyo, 174-8580 Japan.
©2013 TOPCON CORPORATION
ALL RIGHTS RESERVED
0
AUTO KERATO-REFRACTO TONOMETER
4162697041
Printed in Japan 1311-100TH
0
TRK-2P
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