Canon TX-20 User Manual
Full Auto Tonometer
Operation Manual
Make sure you read this manual before using the instrument.
Keep this manual in a safe place so that you can use it in the
future.
L-IE-5191C_TX-20.indb 1 2013/07/18 13:10:07
Important
Disclaimers
Thank you for purchasing the Canon Full Auto Tonometer TX-20 (referred to as “TX-20” in this
manual). Be sure to read this manual thoroughly before using the instrument, and apply the
information that you learn.
• The TX-20 must only be used by a doctor or a legally qualified person.
• The user is responsible for managing the usage and maintenance of medical equipment. We
suggest that a dedicated individual is assigned responsibility for maintenance to ensure that the
TX-20 is kept in good condition and can be used safely.
• Rx Only (USA) Federal law restricts this device to sale by or on the order of a physician.
• Canon takes no responsibility for damage that occurs due to fires, earthquakes, third-party
actions, other accidents, the user's deliberate misuse, negligence, experimentation, or use under
other abnormal conditions.
• Canon takes no responsibility for direct or consequential damages resulting from the use or the
inability to use the TX-20.
• Canon takes no responsibility for injuries or property damage that may occur if safety precautions
are not followed or the instrument is used for something other than its intended purpose.
• Medical examinations are the responsibility of a doctor. Canon takes no responsibility for
diagnostic results.
Installation
Trademarks
Copyright
2
• The information in this manual may be changed without prior notice.
• Although we have made every effort to ensure the accuracy of the information in this manual, if
you have any questions regarding the contents, please contact your sales representative or local
Canon dealer.
• Request your sales representative or local Canon dealer to install the TX-20.
• Canon and the Canon logo are trademarks of Canon Inc.
• Other system names and product names that appear in this manual are trademarks of their
respective companies.
• The copyright of this manual belongs to Canon Inc.
• Unauthorized reproduction, duplication, or reprinting of this manual in whole or in part is
prohibited.
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Contents
1 Introduction ................................................................................................. 5
2 Safety ........................................................................................................... 8
3 Names of Parts ......................................................................................... 19
Features ...................................................................................................... 5
Indications for Use ..................................................................................... 5
Components ............................................................................................... 6
Conventions Used in This Manual ............................................................. 7
Regulatory Information ...............................................................................8
Safety Precautions ................................................................................... 10
Notes on Using TX-20 .............................................................................. 14
Labels and Symbols ................................................................................. 17
Main Unit (From the Examiner's Side) ...................................................... 19
Main Unit (From the Patient's Side).......................................................... 20
Bottom Side.............................................................................................. 21
Operation Panel ........................................................................................ 22
Operation Lever ........................................................................................ 23
Monitor Panel ........................................................................................... 24
Measurement Screen ............................................................................... 25
PATIENT ID Screen ................................................................................... 27
DATA Screen ............................................................................................. 28
MENU Screen ........................................................................................... 29
Screen that Appears When Measurement Fails ...................................... 30
Anterior Segment Image Display Screen .............................................. 30
Anterior Segment Image and Intraocular Pressure Measurement
Waveform Display Screen ...................................................................... 31
Other Screens .......................................................................................... 32
USB Connection Check Screen ............................................................32
Print Message Input Screen .................................................................32
User Name Input Screen ....................................................................... 33
Password Input Screen ......................................................................... 33
Computer Name Input Screen ............................................................... 34
Output Folder Name Input Screen ....................................................... 34
LCD Brightness Adjustment Screen ..................................................... 35
Description of Printouts .......................................................................... 36
4 Basic Operation ........................................................................................ 37
Flow of Operations ................................................................................... 37
Connecting Cables .................................................................................. 38
Preparations Prior to an Examination ...................................................... 40
Patient Setup ............................................................................................ 41
Measuring ................................................................................................. 43
Finishing an Examination ......................................................................... 47
Power Saving Mode ................................................................................. 48
Recovering from the Power Saving Mode ............................................. 48
5 Types of Measurements........................................................................... 49
Measurement Screen ............................................................................... 49
Changing the Alignment Mode .............................................................49
Changing the Number of Measurements ............................................. 50
Changing the Eye Fixation Lamp .......................................................... 51
PATIENT ID Screen .................................................................................. 51
Input Patient ID in the PATIENT ID Screen ............................................ 52
Input Patient ID from an External Device .............................................. 56
MENU Screen .......................................................................................... 57
MENU Screen Display and Functions of Buttons ................................ 57
3
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Basic Operations on MENU Screen .....................................................58
Common Settings in Measurement Modes .......................................... 61
Settings for Intraocular Pressure Measurements ................................. 62
Settings for Printing .............................................................................. 63
Settings for Patient ID Input Interface .................................................. 64
Settings for Interface of Output of Measurements ............................... 64
Settings for Patient No. ......................................................................... 67
Settings for Patient ID ........................................................................... 68
Setting the Time, Date, and Power Saving Mode ..................................69
Settings for the LCD ..............................................................................69
Checking Firmware ............................................................................... 70
6 Maintenance .............................................................................................. 71
Daily Inspections ..................................................................................... 71
Cleaning and Disinfection ........................................................................ 72
Refilling Chin Rest Paper ......................................................................... 74
Replacing Printing Paper ......................................................................... 74
Preparations for Packing and Transport ................................................. 76
7 Troubleshooting ........................................................................................ 77
Symptom and Remedy ............................................................................ 77
Message and Remedy ............................................................................. 78
Appendix ....................................................................................................... 87
Specifications ........................................................................................... 87
Stylesheet File .......................................................................................... 88
EMC (Electromagnetic Compatibility) ...................................................... 90
Warranty and Repair Service ................................................................... 95
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Introduction
1
Features
The Canon Full Auto Tonometer TX-20 has full auto-alignment for intraocular pressure measurement.
The features of these products are shown below.
Three alignment modes
• In full auto mode, both eyes are measured and the results are printed automatically, shortening the
time used for measuring.
• In auto mode, auto-alignment and measurement are performed each time the measurement
button is pressed. The examiner can monitor the condition of the patient’s eyes while measuring
them.
• In manual mode, measurements can be performed manually such as when the patient’s pupil is
eccentric or cornea is deformed.
Compact, with superior operability
More compact and more lightweight than the previous model. Upright operations, patient care,
alignment operation have been greatly improved with a tiltable color LCD monitor and powered
operation lever.
Enhanced external interface
Measurement data can be exported via RS-232C connections or to a LAN. Patient ID can be input
from a USB device.
Indications for Use
For USA
The Canon Full Auto Tonometer TX-20 is intended to be used for the measurement of intraocular
pressure of the human eye.
For European Union
The TX-20 measures the intraocular pressure detecting the change of the cornea surface and the
result will be provided for diagnosis.
5
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1 Introduction
Components
Full Auto Tonometer TX-20
Main unit
Power cord
Connects the TX-20 to an AC
outlet (3m).
USA and Canada only:
Plug type: VM0275 Hospital-
Grade
Nozzle cap
Initially covers the nozzle.
Ferrite core
If a LAN cable is being used,
attach the ferrite core to it.
Operation manual for the TX-20—this document
Describes the handling precautions and operating instructions for the TX-20.
Chin rest paper
100 sheets provided.
Printing paper
2 rolls provided.
Dust cover
Use it to cover the TX-20 when
the instrument is not being
used.
Warranty Card (for USA model only)
WEEE Directive Leaflet (for EU model only)
Installation Report
Optional products
Chin rest paper—500 sheets
Printing paper—10 rolls
6
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Conventions Used in This Manual
This manual uses the following symbols to indicate precautions that are important for using the TX-20
safely. Always follow these safety precautions.
1 Introduction
WARNING
CAUTION
CAUTION
A warning that incorrect operation may result in death or serious injury.
A caution that incorrect operation may result in serious injury.
A caution that incorrect operation may break the TX-20 or damage other
devices.
This symbol indicates actions that must not be taken (prohibited actions).
This symbol indicates actions that must be taken.
This symbol indicates important advice that we strongly recommend be
followed while operating the TX-20.
This symbol indicates supplementary explanations or advice for operating the
TX-20.
References
This manual uses the following style to indicate reference destination.
Example: (see page 15)
7
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Safety
2
Regulatory Information
The following sections list the classifications applicable to the TX-20 and the directives and standards
that the TX-20 complies with.
Device Classification
Type of protection against electric shock Class I equipment
Degree of protection against electric shock Type B applied parts
Degree of protection against ingress of water IPX0
(Chin rest, forehead rest)
Degree of safety of application in the presence of a
flammable anaesthetic mixture with air or with oxygen or
nitrous oxide
Mode of operation Continuous operation
Directives and Standards
USA and Canada
UL 60601-1:2003
CAN/CSA C22.2 No.601.1-M90
IEC 60601-1: 1988/A1: 1991/A2: 1995
IEC 60601-1:2005 Medical electrical equipment - Part1: General requirements
IEC 60601-1-1: 2000 Medical electrical equipment – Part 1-1: General
IEC 60601-1-2: 2001/A1:2004
IEC 60601-1-2:2007
Not suitable
Medical electrical equipment – Part 1: General requirements
for safety
for basic safety and essential performance
requirements for safety – Collateral standard: Safety
requirements for medical electrical systems
Medical electrical equipment – Part 1-2: Collateral standard:
Electromagnetic compatibility – Requirements and tests
IEC 60601-1-4: 1996/A1: 1999 Medical electrical equipment – Part 1-4: Collateral standard:
Programmable electrical medical systems
IEC 62304: 2006 Medical device software – Software life-cycle processes
IEC 62366: 2007 Medical device – Application of usability engineering to
medical devices
ISO 15004-1: 2006 Ophthalmic instruments – Part 1: General requirements
applicable to all ophthalmic instruments
ISO 15004-2: 2007 Ophthalmic instruments – Part 2: Light hazard protection
8
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2 Safety
ISO 10993-1: 2009
ISO 10993-5: 2009
ISO 10993-10: 2010
ISO 8612: 2001
ANSI Z80.10-2003
Biological evaluation of medical devices – Evaluation and
testing
Ophthalmic instruments – Tonometers
European Union
93/42/EEC Medical Device Directive
EN 60601-1:2006 Medical electrical equipment - Part1:General requirements
for basic safety and essential performance
EN 60601-1-2: 2007 Medical electrical equipment – Part 1-2: Collateral standard:
Electromagnetic compatibility – Requirements and tests
EN 60601-1-6: 2010 Medical electrical equipment – Part 1-6: Collateral standard:
Usability
EN 62304: 2006 Medical device software – Software life-cycle processes
EN 62366: 2008 Medical device – Application of usability engineering to
medical devices
EN ISO 14971: 2009 Medical device – Application of risk management to
medical devices
EN ISO 15004-1: 2009 Ophthalmic instruments – Part 1: General requirements
applicable to all ophthalmic instruments
ISO 15004-2: 2007 Ophthalmic instruments – Part 2: Light hazard protection
EN ISO 10993-1: 2009
EN ISO 10993-5: 2009
EN ISO 10993-10: 2010
ISO 8612: 2001 Ophthalmic instruments – Tonometers
Biological evaluation of medical devices
9
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2 Safety
Safety Precautions
To prevent injuries and data loss, operate the TX-20 correctly by following the safety precautions.
WARNING
Prohibi ted
Prohibi ted
Prohibi ted
To avoid the risk of electric shock, this instrument must only
be connected into a supply mains with protective earth.
Do not damage the power cord.
• Do not place anything heavy onto the power cord.
• Do not damage or modify the power cord.
• Do not forcibly bend, twist or pull the power cord.
• Do not hold the power cord when removing it from the AC outlet. Be sure to hold
the plug.
Handle the power cord carefully. If the cord is damaged, contact your sales
representative or local Canon dealer for a replacement. A damaged cord may result
in fire or electric shock.
Do not use a multiple power strip and an extension cable.
Connect the power cord directly to the AC outlet. Do not use a multiple power strip
and an extension cable with it.
Do not disassemble or modify.
A disassembled or modified instrument may result in fire or electric shock. Because
the TX-20 incorporates high-voltage parts that may cause electric shocks, touching
them may cause death or serious injury.
Prohibi ted
Prohibi ted
Do not leave alcohol, thinner, or any flammable chemicals
near the instrument.
Do not place near to a flammable solvent. Fire may result if the solvent spills or
evaporates and makes contact with the internal electric parts. Some disinfectants
are flammable. Be sure to take precautions when using them.
Stop using immediately if there is an abnormality or problem.
If an abnormality occurs, immediately unplug the power plug
and turn off the power of all the devices.
• Smoke is emitted
• An unusual smell
• An unusual noise
• Foreign matter gets inside
• Damaged
Fire or electric shock may result if you continue use in such conditions. Immediately
turn off the power of TX-20, unplug the power plug and turn off the power of all
connected devices. Then, contact your sales representative or local Canon dealer.
Do not place anything on top of the device.
Fire or electric shock may result if water or any other liquid or a needle, paper clip or
any foreign matter gets inside the TX-20.
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2 Safety
WARNING
Prohibi ted
Prohibi ted
Prohibi ted
Do not use a power supply voltage other than the one
specified on the rating label.
Do not use any power cord other than the one supplied.
Use the power voltage specified on the rating label. Otherwise, fire or electric shock
may result.
The supplied power cord is designed exclusively for this product. Do not use any
other power cord.
Do not plug or unplug the power plug with wet hands.
Do not plug or unplug the power plug or handle any other parts with wet hands.
Otherwise, fire or electric shock may result.
Unplug the plug periodically and remove any dust or dirt
around the plug and the AC outlet.
If the cord is kept plugged in for a long time in a dusty, humid or sooty environment,
dust around the plug will attract moisture, resulting in possible insulation failure that
may result in a fire.
Insert the power plug completely.
Insert the power plug completely into the AC outlet. If a pin of the power plug makes
contact with metal or any conductive object, fire or electric shock may result.
Do not clean the TX-20 with flammable solvent.
For safety reasons, before cleaning the TX-20, be sure to turn off the power of all
the devices and unplug the power cord from the AC outlet. Do not use alcohol that
is not for cleaning, benzene, thinner or any other flammable solvent.
Otherwise, fire or electric shock may result.
Prohibi ted
Prohibi ted
Turn off the power before inspection.
For safety reasons, before inspecting the instrument or cables, be sure to turn off
the power of all the devices.
Otherwise, electric shock may result.
Do not measure an eye whose cornea is frail due to corneal
disease or surgery.
Otherwise, complications may occur.
Be sure to turn off the power before moving the TX-20.
When moving the TX-20, always move the measurement unit to the packing position
(see page 76), turn off the power, unplug the power cord, and disconnect any external
equipment. Otherwise, the cable may be damaged, which may result in fire or
electric shock.
Use the indentations for lifting and moving the TX-20.
When lifting the TX-20, hold it on the bottom and keep it level. Do not hold it by the
head rest, nozzle or LCD monitor, as they may come off and result in injury.
Do not touch conductive parts of non-medical equipment and
the patient simultaneously.
Otherwise, electric shock may result.
CAUTION
Do not install in locations exposed to water, steam, moisture
or dust.
Prohibi ted
Doing so may cause problems or malfunctions.
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2 Safety
CAUTION
Prohibi ted
Prohibi ted
Prohibi ted
Prohibi ted
Prohibi ted
Do not install in locations exposed to salt, sulfur or corrosive
gas.
Doing so may result in corrosion of the instrument, problems or malfunctions.
Do not install in locations that are unstable or exposed to
vibration.
The vibration may knock over the instrument or the instrument may become
unbalanced and fall, resulting in a malfunction or injury.
Do not place anything near the power plug.
To make it easy to unplug the power plug at any time, avoid putting any obstructions
near the AC outlet.
Fire or electric shock may result if the power plug is not unplugged during an
emergency.
Do not block the vent holes.
Doing so may cause the internal temperature to rise and result in fire.
Do not put your hands or fingers near the measurement unit.
Your hand or fingers may be pinched and injured.
Similarly, instruct the patient not to place his/her hands or fingers on the base.
Hold the TX-20 when connecting or disconnecting a cable.
For safety reasons, when connecting or disconnecting the power cord or any
cable be sure to hold the main unit. Otherwise, the main unit may fall over, possibly
causing injury.
Ensure that the entire system conforms to IEC 60601-1-1.
Use the computer and other equipment that conform to the system standard IEC
60601-1 or IEC 60950-1 for the Full Auto Tonometer TX-20. Be sure that the entire
system conforms to IEC 60601-1-1. Be sure to also use an isolation transformer
conforming to IEC 60601-1 when a computer conforming to IEC 60950-1 is used.
Otherwise, electric shock may occur. Ask your sales representative or local Canon
dealer to connect it to a computer.
Use an isolation transformer for LAN connections.
If the LAN connector is being used to connect to a network, connect an isolation
transformer for networks between the TX-20 and network devices (HUB etc.) and
between network devices.
If this is not done, there is a risk of short circuits or malfunctioning devices. Ask your
sales representative or local Canon dealer to connect it to a network.
Turn off the power and unplug the power cord before
connecting cables.
Always turn off the power and unplug the power cord before connecting the cables
of any external devices to the TX-20.
If this is not done, there is a risk of damage.
Always disinfect the nozzle after measuring an infected
patient’s eyes.
A patient’s tears may get on the nozzle and cause a secondary infection. Always use
a cotton swab or other appropriate material that has been treated with disinfectant
ethanol to wipe the nozzle.
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2 Safety
CAUTION
Prohibi ted
Keep the forehead rest and chin rest clean.
To prevent the risk of infection, wipe the forehead rest with disinfectant ethanol for
each patient. To ensure cleanliness, replace the chin rest paper for each patient.
If the chin rest paper is not being used, be sure to disinfect the chin rest for each
patient.
For details on how to disinfect, consult a specialist. The forehead rest may be
corroded if a disinfectant other than those above is used.
Be sure to turn off the power when not in use.
For safety reasons, be sure to turn off the power of all the devices when the TX-20
is not being used.
Also, remove the power plug from the AC outlet and put on the cover when the TX20 is not going to be used for a long time.
Otherwise, dust or any foreign matter may accumulate and result in fire.
Make sure to select the position where the nozzle stops for
each patient.
Look from the side of the patient when setting the stop position to see that the
patient’s forehead and chin are firmly against the forehead rest and chin rest. If the
stop position is not set correctly, the nozzle may contact the patient’s eye and result
in injury.
Do not touch the cutter for the printer.
Do not touch the cutter for the printer. Similarly, instruct the patient not to touch the
cutter for the printer.
Otherwise, it may result in injury.
CAUTION
Prohibi ted
Prohibi ted
Do not touch the area around the printer or open the paper
cover during or immediately after printing.
The printer’s thermal head and the surrounding area are very hot during and
immediately after printing. To prevent burns, wait for the printer to cool before
opening the paper cover to replace paper.
Do not touch the measurement unit and the chin rest while
they are moving.
The measurement unit and the chin rest move when the power is turned on, full
auto is set, or the CHIN REST button is pressed. Do not touch the measurement
unit or the chin rest while they are moving. Keep the patient’s chin away from the
chin rest.
Use the product’s packaging to transport it.
Use the TX-20 packing materials to protect it from vibration and shocks when it is
transported on a cart, in a vehicle, or if shipped over long distances.
Vibration or shock may cause a breakdown or damage the TX-20.
For details, contact your sales representative or local Canon dealer.
Inspect daily and periodically.
For safety reasons, before using the TX-20, be sure to perform the daily inspection.
Have a periodically inspection performed for the TX-20 at least once a year by a
Canon designated representative to maintain its performance and reliability.
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2 Safety
Notes on Using TX-20
Before Use
• Sudden heating of the room in cold areas will cause condensation to form on the optical
component of the nozzle and on optical parts inside the instrument. In this case, wait until
condensation disappears before performing a measurement.
During Measurement
• Describe to the patient what to expect during measurement so he/she will not be surprised by
the sudden air puff. Demonstrate the intensity of the air puff by having the patient place a finger in
front of the nozzle and then press the CHECK button.
• The measurement unit automatically moves after the power is turned on. Do not prevent
movement of the measurement unit by holding it or placing something near it.
Do not let the patient place his/her chin on the chin rest until the measurement unit stops.
• It is recommended that a hard copy of the printout be made if you wish to store it for a long time,
because printouts on thermal paper are apt to deteriorate.
After Use
• Turn off the power, put the cap over the optical component of the nozzle in order to prevent dust
from attaching to it, and place the dust cover over the instrument.
During Cleaning and Disinfection
• If the surface of the optical component of the nozzle is wiped when dust or dirt is on it, it will be
scratched. Also, do not wipe the optical component with alcohol, including disinfectant ethanol or
silicone-coated paper. Otherwise, the surface will be corroded or stained.
• Use neutral detergent for cleaning the outside of the TX-20. Do not use neutral detergent for
cleaning the LCD monitor. See below for LCD cleaning instructions.
LCD Monitor
• Approximately 99.99% of the dots in high-technology LCD monitors are functional. About 0.01% of
the dots may be missing or might appear as a bright spot. This is not a malfunction.
• The polarization plate on the surface of the monitor is very fragile. Be careful when handling it and
do not press or rub any hard objects against it.
• Wipe water or saliva from the polarization plate on the monitor’s surface immediately; leaving it for
a long time may cause distortion or discoloration.
• If the surface is dirty, use something soft, such as an absorbent cotton cloth, with a small amount
of ethanol, and lightly wipe it.
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Environment of Use
• Use, store, and transport the TX-20 in an environment that is within the range of the following
conditions. Use the original packaging to store or ship it.
Environment of use 10 to 40°C 30 to 90% RH (no
Storage and transportation
environment
• Do not install, store, or leave the TX-20 in a very hot or humid environment. Also, do not use the
TX-20 outside. Doing so may cause a malfunction or misoperation.
• After many years of usage, airborne dust in the room may get on the nozzle as well as the optical
parts in the main unit and prevent accurate measurement.
• When the TX-20 is not being used, attach the nozzle cap and place the dust cover over the TX-20.
Installation
• Request your sales representative or local Canon dealer to install the TX-20.
• A strong shock to the TX-20 may put it out of alignment. Please handle the unit carefully.
Temperature Humidity Atmospheric pressure
600 to 1060 hPa
condensation)
–30 to 50°C 10 to 95% RH (no
condensation)
600 to 1060 hPa
2 Safety
Transportation
• Be sure to turn off the TX-20’s power switch, remove the AC plug from the outlet, and disconnect
any cables connected to other equipment.
• When moving the TX-20, perform the specified operation to move the measurement unit to the
transport position (see page 76).
• Remove the paper from the printer before moving the TX-20.
• Carry the TX-20 by the indentations for lifting at its front and rear, and keep it level.
• Do not hold anything except the indentions for lifting when lifting the TX-20.
• The TX-20 needs to be protected from vibration and shocks when it is transported on a cart, in a
vehicle, or if shipped over long distances. Always use the original packaging. For details, contact
your sales representative or local Canon dealer.
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2 Safety
Disposal
Disposal of this product in an unlawful manner may have a negative impact on human health and
on the environment. Therefore, when disposing of this product, be absolutely certain to follow the
procedure which is in conformity with the laws and regulations applicable to your area.
European Union (and EEA*) only
This symbol indicates that this product is not to be disposed of with your
household waste, according to the WEEE Directive (2002/96/EC) and your national
law. This product should be handed over to a designated collection point, e.g.,
on an authorized one-for-one basis when you buy a new similar product or to an
authorized collection site for recycling waste electrical and electronic equipment
(EEE). Improper handling of this type of waste could have a possible negative
impact on the environment and human health due to potentially hazardous
substances that are generally associated with EEE. At the same time, your
cooperation in the correct disposal of this product will contribute to the effective
usage of natural resources. For more information about where you can drop off
your waste equipment for recycling, please contact your local city office, waste
authority, approved WEEE scheme or your household waste disposal service.
For more information regarding return and recycling of WEEE products, please visit
www.canon-europe.com/WEEE.
* EEA: Norway, Iceland and Liechtenstein
For California, USA Only
The battery in this device contains perchlorate material. Special handling may apply.
See http://www.dtsc.ca.gov/hazardouswaste/perchlorate
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Labels and Symbols
The position and contents of the label attached on the TX-20 are shown below.
2 Safety
USA and Canada
European Union
The following table describes the symbols and indications on the TX-20.
USA and Canada
Alternating current
Type B
Caution: Check the documentation provided.
MEDICAL EQUIPMENT
WITH RESPECT TO ELECRICAL SHOCK,
FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH UL 60601-1 AND CAN/CSA C22.2 NO. 601.1
41C4
Caution: Federal law (USA) restricts this device to sale by or on the
order of a physician.
Year and month of manufacture Example: October 2010
Serial number in SIX digits Example: 123456
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2 Safety
European Union
Alternating current
Type B
Caution: Check the documentation provided.
Product that WEEE directive, Directive on Waste Electrical and
Electronic Equipment, 2002/96/EC, requires separate collection.
This symbol shows compliance of the equipment with Directive 93/42/
EEC.
This symbol indicates that a User’s Manual is supplied with this
equipment.
Manufacturer’s name and address
Serial number in SIX digits Example: 123456
Year and month of manufacture Example: October 2010
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Names of Parts
3
Main Unit (From the Examiner's Side)
1
2
3
4
5
6
1 Measurement unit
Measurement is done at this part.
2 Height adjustment mark
Align the patient's eye with this mark.
3 LCD monitor
The patient's eye and various screens appear here.
4 Operation panel
Operations such as setting the nozzle position,
chin rest height, and printing are done from here.
7
5 Printer
Prints the measurement results.
6 Operation lever
7 Indentation for lifting
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3 Names of Parts
Main Unit (From the Patient's Side)
1
2
3
4
1 Forehead rest
Patient rests his/her forehead here to prevent
patient's eye from moving.
2 Nozzle
Blows air for observing or measuring the patient's
eye.
3 Head rest
4 Power switch
Turns on the power for the main unit.
5
6
7
5 External eye fixation lamp
Used if it is difficult to fix the patient's eye by using
the internal eye fixation lamp. Fix on the eye that is
not being measured.
6 Chin rest
The patient’s chin is placed here. Raise or lower
the chin rest to set the appropriate height for the
patient’s eye(s).
7 Indentation for lifting
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L-IE-5191C_TX-20.indb 20 2013/07/18 13:10:18
Bottom Side
3 Names of Parts
1
2
3
4
1 RS-232C connector
Transfers measurement data to an external device.
Can be connected to a device that supports the
RS-232C standard.
2 USB connector
Reads patient ID from an external device.
Using the RS-232C or LAN connector
See “Safety Precautions” (see page 12) and “Settings for Interface of Output of Measurements” (see
page 64).
3 AC power connector
4 LAN connector
Transfers measurement data to an external device.
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L-IE-5191C_TX-20.indb 21 2013/07/18 13:10:18
3 Names of Parts
Operation Panel
5
1
2
3
4
1 POWER lamp
Lights when power is turned on.
2 R/L button
Switches between the patient's left and right eye
as the measurement unit moves automatically.
3 CHIN REST button
Moves the chin rest up and down to align the
height of the patient's eye.
4 PRINT button
• Prints the measurement results. Sends the
measurement results to an external device if one
is connected and the settings have been done in
advance.
• Pressing the PRINT button for 2 seconds or
more prints or transmits the measured value and
standard value for the number of measurements
(see page 63).
• For the preparation for the next measurement,
the settings change as shown below.
- Nozzle stop position: Releases the setting.
- Selection of eye fixation lamp: The internal eye
fixation lamp is selected.
The external eye fixation lamp turns off and the
internal eye fixation lamp flashes.
- Patient ID: The patient ID is cleared* (not
entered state).
- Patient No: Counts up the patient numbers
(however, according to settings).
- Display of measured value: Measured values
are cleared* (not measured state).
- Measurement unit: Returns to the initial position.
6
7
5 LIMITER button
Sets the stop position to prevent the measurement
unit from touching the patient.
6 CHECK button
Blows air from the nozzle.
7 Paper cover button
* You can confirm the patient ID or measured value on the DATA screen until the measurement button
is pressed.
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Operation Lever
3 Names of Parts
2
3
1
4
1 Operation lever
Tilt the operation lever to move the measurement
unit.
Tilt right or left: Moves slightly to right or lef t.
Tilt front or back: Moves slightly to the front or back.
Tilt past the maximum to the front, back, left, or right:
Motion is great.
2 Alignment off button
While the button is pressed, the measurement
unit does not move even if the operation lever is
tilted. Use to adjust the angle of the operation
lever without moving the measurement unit. For
example, it can be used if the operation lever is at
an awkward and difficult-to-manipulate angle when
aligning with the patient’s eye.
3 Measurement button
Starts the measurement.
4 Measurement unit’s vertical movement ring
Turn the ring right and left to move the
measurement unit up and down.
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3 Names of Parts
Monitor Panel
1
1
1 Soft keys
The purpose of soft keys varies according to the assigned function. An icon on the monitor near the soft key
indicates the purpose assigned to the soft key.
Pressing a soft key changes and sets functions, and changes the screen.
In this manual, these soft keys are indicated by the name of their functions.
Alignment
mode key
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L-IE-5191C_TX-20.indb 24 2013/07/18 13:10:19
Measurement Screen
This screen appears when doing measurements.
You can set the measurement functions, show the most recent measurement data, and switch
screens.
3 Names of Parts
1
2
3
4
5
6
7
8
9
10
1 Patient ID/Patient No.
2 Measurement range
3 Display order of measurement value
: From highest to lowest reliability, 1 to 3.
: From newest to oldest measurement, 1 to 3.
4 LIMITER OFF mark
Indicates the LIMITER function is disabled.
5 Measurement results history
Shows the results of measurements according to
age or reliability.
6 Low reliability mark
This mark appears when reliability of the
measurement is considered low as the result of the
analysis of the measured value.
7 Alignment circle
Mark for aligning vertical and horizontal position of
patient's eye and measurement unit.
8 Corneal light point
A point that appears optically, indicating alignment
of the position to measure in the patient’s eye and
the measurement unit.
9 Measurement unit motion limit mark
Indicates measurement unit has moved to the limit
position.
10 Alignment guide
This guide is an index that shows the corneal light
point. It only appears in manual alignment mode.
11
12
13
14
15
11 Left/right eye indicator
: Right eye
: Left eye
12 Alignment mode setting
Press the adjacent alignment mode key to switch
the alignment mode.
13 Most recent intraocular pressure
Shows the most recent measurement.
14 Measurement count setting
Press the adjacent measurement count key to
switch the measurement count setting. Only
enabled in full alignment mode.
15 Level of received light
Indicates the amount of light received from light
reflected from cornea when measuring intraocular
pressure. The number of lines increases as the
amount of received light increases.
If there is little received light, light reflected from
the cornea may be obstructed by the eyelid or
eyelashes. However, it is also affected by the
corneal reflectivity of the patient.
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L-IE-5191C_TX-20.indb 25 2013/07/18 13:10:20
3 Names of Parts
16
17
18
20 21 2219
16 Intraocular pressure standard value
Representative intraocular pressure value that
was statistically derived from measured values.
Measured values with a low reliability mark are not
used.
17 Eye fixation lamp
Press the adjacent eye fixation lamp key to switch
the internal and external eye fixation lamps.
18 External device connection status
Shows the status of external device connection.
19 ID key
Press to switch to the PATIENT ID screen.
20 MENU key
Press to switch to the MENU screen.
21 DATA key
Press to switch to the DATA screen.
22 CLS key
Press to do the following.
• Nozzle stop position: Releases the setting.
• Selection of eye fixation lamp: The internal eye
fixation lamp is selected.
The external eye fixation lamp turns off and the
internal eye fixation lamp flashes.
• Patient ID: The patient ID is cleared* (not entered
state).
• Patient No: Counts up the patient numbers
(however, according to settings).
• Display of measured value: Measured values are
cleared* (not measured state).
• Measurement unit: Returns to the initial position.
* You can confirm the patient ID or measured value on the DATA screen until the measurement button
is pressed.
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PATIENT ID Screen
This screen is used to input patient IDs.
3 Names of Parts
1
2
3
4
5
8
1 Patient ID area
The text selected from the list of characters
appears in the patient ID input field.
A maximum of 64 ASCII code characters can be
input.
2 ID cursor
Shows the position where the patient ID can be
edited.
3 List of characters
List of characters that can be input for a patient ID.
4 Selection cursor
Select characters to input for a patient ID.
5 ID cursor movement commands
The ID cursor moves in the direction of the selected
arrow.
6 ID delete command
[BS]: Deletes the character that is before the
character specified by the ID cursor. However, if
the ID cursor is specifying the first character, it
deletes that character.
[CLS]: Deletes all the characters in the patient ID.
The confirmation screen is displayed; select one of
the following.
• [OK]: Deletes all text.
• [CANCEL]: Does not delete.
6
7
9
10
7 Operation reference guide
Shows the types of buttons that can be operated
in the PATIENT ID screen. Refer to "5 Types of
Measurements" for operating procedures.
8 MEASURE key*
Press to switch to the Measurement screen.
9 MENU key*
Press to switch to the MENU screen.
10 DATA key*
Press to switch to the DATA screen.
* By doing the settings in advance, if a patient ID has not been input when it is pressed, a message
indicating that the patient ID has not been input is displayed (see page 68).
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L-IE-5191C_TX-20.indb 27 2013/07/18 13:10:20
3 Names of Parts
DATA Screen
This screen shows measurements.
1
7
1 Intraocular pressure
: Shows measurements from highest to
lowest reliability in order 1 to 10. (Measurement
number: Up to 10)
: Shows measurements from newest to
oldest in order 1 to 10. (Measurement number: Up
to 10)
2 Eye being measured
R: Right eye
L: Left eye
3 Level of received light
Indicates the amount of light received from light
reflected from cornea when measuring intraocular
pressure. The number of lines increases as the
amount of received light increases.
If there is little received light, light reflected from
the cornea may be obstructed by the eyelid or
eyelashes. However, it is also affected by the
corneal reflectivity of the patient.
4 Low reliability
This mark appears when the analysis of the results
or reliability of the measurement is considered
low. Measured values that have this mark are not
included in the standard value calculation.
5 Intraocular pressure standard value
Representative intraocular pressure value that was
statistically derived from measured values. Measured
values with a low reliability mark are not used.
6 External device connection status
Shows the status of external device connection.
: USB device is connected
:
Error has occurred in USB device connection
: LAN is connected
: RS-232C device is connected
No display: No connection
8
9
10
7 ID key
Press to switch to the PATIENT ID screen.
8 MEASURE key
Press to switch to the Measurement screen.
9 MENU key
Press to switch to the MENU screen.
10 DELETE key
Press to clear all the measurements.
The measurement values are deleted from the
instrument’s memory.
2
3
4
5
6
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L-IE-5191C_TX-20.indb 28 2013/07/18 13:10:21
MENU Screen
3 Names of Parts
Perform the settings for measurements, printing, and operating the measurement unit.
1
2
6
1 Settings tab
The items to set are grouped according to their
purpose. Selected items are shown in orange.
Measure tab: Settings for intraocular
pressure measurements
Print tab: Settings for printing with the built-
in printer
Input tab: Settings for inputting data from an
external device
Output tab: Settings for outputting data to
an external device
Patient tab: Settings for patient ID and
patient No.
Other tab: Settings for time, power saving
mode, and the LCD, and shows information about
the firmware.
2 Setting items
The setting items for each tab are displayed.
3 Name of the selected tab
4 Cursor
Shows the position of the selected setting value,
setting item, and tab. They light orange when
selected.
3
4
5
9
7
8
5 Settings
The settings for each setting item are displayed.
6 ID key
Press to switch to the PATIENT ID screen.
7 MEASURE key
Press to switch to the Measurement screen.
8 DATA key
Press to switch to the DATA screen.
9 External device connection status
Shows the status of external device connection.
: USB device is connected
: Error has occurred in USB device
connection
: LAN is connected
: RS-232C device is connected
No display: No connection
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L-IE-5191C_TX-20.indb 29 2013/07/18 13:10:22
3 Names of Parts
Screen that Appears When Measurement Fails
Anterior Segment Image Display Screen
If a measurement error occurs while measuring intraocular pressure, the anterior segment image
from just prior to measuring is displayed. The anterior segment image disappears after 5 seconds or
if you press a soft key.
If [OFF] is set for [Error Display] in the intraocular pressure measurement menu, the anterior
segment image is not displayed (see page 62).
1
2
1 Eyelid warning line
Perform the measurement while the eyelid and
eyelashes are above the warning line.
2 Cross mark
Displays the intraocular pressure measurement
optical axis.
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