INSTRUCTION MANUAL

Specular Microscope

EM-4000

Read this manual thoroughly before using the instrument to

ensure proper and safe operation.
Contact Tomey Corporation or our local distributor if you have
any questions or you encounter any problems during
operation.

Always follow the operation procedures

described in this manual.

Keep this manual in a readily accessible

location while operating the instrument.

Contact our local distributor if you lose this

manual.

603A9090-0B

i Important Safety Information

Do not install this instrument in a location where explosives or inflammable

substances are used or stored. Otherwise, fire or explosion may occur.

Do not remove the cover of the instrument. Otherwise you may get an electric
shock.

Do not disassemble or modify the instrument. Otherwise you may get an electric
shock.

Disconnect the power cord from the instrument before servicing the instrument.
Otherwise, you may get an electric shock.

Do not place water or chemicals on the instrument. Any water or chemicals

entering the instrument may cause an electric shock or failure.

Only use the specified terminal for connection of the instrument. Using another
type of terminal may result in failure of the instrument.

This instrument is a diagnostic/capturing device specifically designed for

ophthalmology. Never use the instrument for other purposes.

A metal blade is attached to the printer cover. Touching this blade may result in
injuries, so be sure to pay utmost attention when handling the printer cover.

The terminal for connecting the instrument to external devices is not isolated
from the internal circuit. Inappropriate wiring may damage the internal circuit.
Contact us or our local distributor before using the instrument while connected to
another device.

i-1

ii How to read this manual

Outline
This manual is structured as follows.
1. PRIOR TO USE
Describes safety precautions and important information to be
understood before installing and using the instrument.
2. NAMES AND FUNCTIONS
Describes names and functions of each section of the instrument.
3. OPERATION PROCEDURES
Describes information required for installing and using the instrument.
4. INSPECTION AND MAINTENANCE
Describes procedures for replacing consumable parts, etc. that the
user of the instrument should normally conduct.
5. TROUBLESHOOTING
Describes how to solve problems.
6. CONSUMABLES AND OPTIONAL EQUIPMENT
Describes consumable parts and optional equipment.
7. Specifications
Describes the specifications of the instrument.

Symbols Used In This Manual

Sentences accompanied with the symbols below indicate the
following:

ii-1

This is a precaution that, if unheeded, will result in a hazardous

situation where there is an imminent danger of serious injury or
death.

This is a precaution that, if unheeded, could result in a

hazardous situation where there is a possibility of serious
injury or death.

This is a precaution that, if unheeded, may result in a situation

where there is a possibility of minor or moderate injury or
damage to property.

This is additional information which may contain special

precautions on company policies related, either directly or
indirectly, to the safety of personnel or to the protection of
property.

iii Contents
i Important Safety Information ..................................................................................................................... i-1
ii How to read this manual ........................................................................................................................... ii-2
Outline .......................................................................................................................................................... ii-2
Symbols Used In This Manual ..................................................................................................................... ii-2
iii Contents ................................................................................................................................................... iii-1
1. PRIOR TO USE .......................................................................................................................................... 1-1
1.1 Precautions for operation ...................................................................................................................... 1-1
1.2 Checking package contents .................................................................................................................. 1-5
1.3 Glossary ................................................................................................................................................ 1-6
1.4 Overview ............................................................................................................................................... 1-8
2. NAMES AND FUNCTIONS ........................................................................................................................ 2-1
2.1 Physician's side .................................................................................................................................... 2-1
2.2 Patient's side ......................................................................................................................................... 2-2
2.3 Sides of the main unit ........................................................................................................................... 2-3
2.4 Screen ................................................................................................................................................... 2-4
2.4.1 Basic structure and common items ................................................................................................ 2-4
2.4.2 Capture screen ............................................................................................................................... 2-5
2.4.3 Image selection screen .................................................................................................................. 2-7
2.4.4 Analysis screen .............................................................................................................................. 2-8
2.5 Symbols used for marking .................................................................................................................. 2-10
3. OPERATION PROCEDURES .................................................................................................................... 3-1
3.1 Safety precautions ................................................................................................................................ 3-1
3.2 Preparation before use ......................................................................................................................... 3-1
3.2.1 Connections ................................................................................................................................... 3-1
3.2.2 Starting/shutting down the instrument ........................................................................................... 3-3
3.2.3 Clearing the last examination data (preparation for a new patient) ............................................... 3-4
3.2.4 Entering the patient data ................................................................................................................ 3-4
3.2.5 Patient's eye height adjustment ..................................................................................................... 3-6
3.2.6 Setting the fixation light position .................................................................................................... 3-7
3.2.7 Setting capturing conditions ........................................................................................................... 3-7
3.3 How to capture images ......................................................................................................................... 3-9
3.3.1 Selecting the eye to be measured ................................................................................................. 3-9
3.3.2 Alignment ....................................................................................................................................... 3-9
3.3.3 Capturing endothelium tissue image............................................................................................ 3-12
3.3.4 Selecting image............................................................................................................................ 3-14
3.4 Analysis ............................................................................................................................................... 3-15
3.4.1 Auto Analysis ................................................................................................................................ 3-15
3.4.2 L-count method ............................................................................................................................ 3-23
3.4.3 Core method ................................................................................................................................ 3-26
3.5 Export, Print, and Save ....................................................................................................................... 3-29
3.5.1 Export ........................................................................................................................................... 3-29
3.5.2 Print .............................................................................................................................................. 3-31
3.5.3 Save ............................................................................................................................................. 3-33
3.6 Database ............................................................................................................................................. 3-34
3.6.1 Browsing examination data .......................................................................................................... 3-34
3.6.2 Deleting examination data ........................................................................................................... 3-35
3.7 System setup ...................................................................................................................................... 3-37
3.7.1 General ........................................................................................................................................ 3-37
3.7.2 Measurement ............................................................................................................................... 3-39
3.7.3 Application .................................................................................................................................... 3-40
3.7.4 Connection & Print ....................................................................................................................... 3-43

iii-1

4. INSPECTION AND MAINTENANCE ......................................................................................................... 4-1

4.1 Warranty................................................................................................................................................ 4-1
4.2 Operation life......................................................................................................................................... 4-2
4.3 Inspection .............................................................................................................................................. 4-2
4.4 Routine maintenance ............................................................................................................................ 4-3
4.5 Replacing consumables ........................................................................................................................ 4-4
4.5.1 Fuses ............................................................................................................................................. 4-4
4.5.2 Built-in printer paper ....................................................................................................................... 4-4
4.6 Storing ................................................................................................................................................... 4-6
4.7 Disposal ................................................................................................................................................ 4-6
5. TROUBLESHOOTING ............................................................................................................................... 5-1
5.1 Common items ...................................................................................................................................... 5-1
6. CONSUMABLES AND OPTIONAL EQUIPMENT ..................................................................................... 6-1
7. Specifications ........................................................................................................................................... 7-1
7.1 Specifications ........................................................................................................................................ 7-1
7.1.1 Capturing scope ............................................................................................................................. 7-1
7.1.2 Central corneal thickness measurement accuracy ........................................................................ 7-1
7.1.3 Central corneal thickness measurement range ............................................................................. 7-1
7.1.4 Main unit ......................................................................................................................................... 7-1
7.2 Operating environment ......................................................................................................................... 7-1
7.3 Classification ......................................................................................................................................... 7-1
7.4 Declaration of Conformity to EMC ........................................................................................................ 7-2

iii-2

1. PRIOR TO USE

Read this manual thoroughly before using the instrument to ensure

proper and safe operation.

Always follow the operation procedures described in this manual.

Check that there are no devices that generate strong magnetic field near
the instrument. A strong magnetic field may cause noise and affect the
capture of images.

1.1 Precautions for operation

Only allow qualified operators to use the instrument.

Precautions when installing the instrument
-

Install the instrument in a location free of water or chemicals. Any water

or chemicals entering the instrument may cause an electric shock or
failure.

Do not install the instrument in a location where chemicals are stored or

gases may occur. Spilt chemicals or vapor may enter the instrument and
result in fire.

Check that the frequency, voltage, and allowable current (or power
consumption) of the power source are appropriate. Otherwise, fire or
electric shock may occur.

Connect the power plug to a grounded 3-pin outlet. Otherwise, a short

circuit due to failure of the instrument may result in electric shock.

Do not place any heavy object on the power cord or squash the power
cord. Fire or electric shock may occur.

Fully insert the power plug into the outlet. Faulty contact, allowing any
metal to contact the exposed terminal of the plug, or dust accumulated
on the exposed terminal of the plug may result in fire or electric shock.

When operating this instrument connected to other devices, only use

devices that comply with IEC60601-1 or that comply with IEC60950-1
and whose power source is isolated with an isolation transformer.
Furthermore, all devices should be configured to comply with the
standard IEC60601-1 ME system.
Anyone who connects any
additional device to the communication connector will be considered a
person configuring a medical system, and is therefore responsible for
complying with the requirements of an IEC60601-1 ME system.
Contact us or our local distributor before connecting the instrument to
another device with a communication connector.

Do not connect a device with data transmission specifications that are

not compatible. Fire or electric shock may occur. Contact us or our local
distributor before using the instrument while connected to another
device.

Conduct grounding work correctly. Otherwise you may get an electric

shock.

1-1

Do not hold the head, chin rest, forehead pad, or joystick when moving
the instrument. These components are detachable and the instrument
may drop, resulting in injuries.

Install the instrument in a location not subject to direct sunlight, high

temperature and humidity, or air containing dust, salt, and/or sulfur.
Otherwise, failure or malfunction may occur.

Install the instrument in a leveled stable location free of vibration or

mechanical impact. Otherwise, images cannot be captured correctly.
Also, the instrument may topple over or fall down, resulting in fire or a
serious accident.

Install the instrument between the patient and physician so that they can
face each other.

Install the instrument in a location with ample clearance from other

devices to allow smooth inspection.

Precautions before using the instrument

-

Check that the instrument works properly by inspecting switch and

button operations, display, and printing.

Check that all cables are connected correctly.

Check the sections that the patient will directly touch.

Peel off the top sheet of chin rest paper and clean the forehead pad with
a cloth dampened with alcohol before capturing images.

Check that the instrument is correctly grounded.

Check that the date set in the instrument conforms to the actual
operation date and time.

Precautions during operation

1-2

Do not place any container with liquid in it on the instrument. Any liquid
entering the instrument may cause electric shock or failure.

If any smoke, offensive odor, or abnormal sound occurs, turn the

instrument off immediately, disconnect the power plug from the outlet,
and contact us or our local distributor.

Do not operate the joystick, touch panel, and membrane button panel
during the initial motion performed before the capture screen appears
after the power switch is turned on. If the initial motion is not completed
correctly, malfunction may be caused when capturing images.

When moving the head and/or chin rest of the instrument, pay attention
to the position of the patient's face, and patients and physicians hands
and fingers. Otherwise, they may be injured by the movement of the
head or chin rest.

Do not allow any person to place their hands or fingers in the clearance
under the head or the section immediately under the chin rest. Their
hands or fingers may be caught and injured.

Never insert fingers or objects through the capture window. Malfunction

or failure of the instrument or faulty analysis results may occur.

Do not lean on the instrument or press the instrument from the top. The
instrument may topple over, resulting in mechanical failure or injuries.

Be careful to not exceed the diagnosis time.

Always check that there is no problem with the instrument and patient to
ensure safety.

If any problem is found with the instrument or patient, take appropriate

action, such as stopping operation, to maintain patient safety.

Immediately stop capturing images if the patient shows any signs of

photosensitive epilepsy.

Faulty fixing of the sight, eyelid drooping, trichiasis, corneal diseases,

etc. may affect the analysis result or measurement of corneal thickness.
When the captured image is unclear, use another image for analysis or
capture another image. If the measurement result of the corneal
thickness is doubtful, review the inspection result by performing
measurement again or another inspection.

When using captured images or analysis results obtained with this

instrument for diagnosis, also refer to the results of other examinations.
Capturing conditions may affect the precision of images or analysis
result.

Do not use the central corneal thickness and ultrasonic correction for
central corneal thickness output from this instrument to directly correct
the eye refractive power. Other examination methods should also be
used in conjunction with the above.

Do not allow the patient to touch the instrument.

Peel off the top sheet of chin rest paper and clean the forehead pad with
a cloth or the like dampened with alcohol before capturing an image for
the next patient.

Precautions after operation

-

Do not place any container with liquid in it on the instrument. Any liquid
entering the instrument may cause electric shock or failure.

Do not use organic solvents such as thinner, benzene, or acetone to

clean the instrument. Fire or electric shock may occur. (These can also
corrode the resin or coating of the instrument cover.)

Hold the plug when disconnecting the power plug from the outlet to avoid
placing excessive force on the cord. Pulling the cord may damage the
inner core wires, resulting in electric shock or fire.

Disconnect the power plug from the outlet to ensure safety when the
instrument is not operated for long periods.

1-3

Refer to "4.6 Storing" for instructions on the storage of the instrument.

Clean the instrument at the end of operation in preparation for the next
use.

Clean and neatly arrange the accessories and cables.

If any failure occurs in the instrument, immediately stop operation, indicate the failure in
the instrument, and contact our local distributor for repairs.

1-4

Do not modify the instrument.Touching the internal circuit may result in

death or serious injuries

Disconnect the power cord from the outlet when replacing fuses.
Otherwise, you may get an electric shock, resulting in death or serious
injuries.

Use the power cord and fuses provided with the instrument or specified
by Tomey to ensure safety. Also, do not use the accessories provided
with the instrument for other equipment.

When any failure occurs in the instrument, indicate the failure in the
instrument and contact our local distributor for inspection and repairs. Do
not attempt to repair the instrument yourself.

Conduct regular inspections of the instrument and components.

When the instrument is not used for 1 month or longer, check that the
instrument is operating correctly and safely before starting operation.
Refer to "4.3 Inspection" in this manual for the checking procedures.

1.2 Checking package contents

Keep the box and packing materials for use when moving or transporting the
instrument.

When taking the instrument out of the box, pull the outer box upward and
then remove the packing materials. Be careful not to lift the instrument by
directly holding the head, chin rest, forehead pad, or joystick. The instrument
may be damaged.

Open the package and check that the required quantity of the following items is
included and they are not damaged. If any item is missing or damaged, contact
our local distributor as soon as possible.

Main unit SPECULAR MICROSCOPE EM-4000 ........................................ 1

Power cord ................................................................................................... 1

Touch pen .................................................................................................... 1

SD card (installed in the main unit) .............................................................. 1

Fuse (2 fuses are installed in the main unit.) ............................................... 4

Chin rest paper ............................................................................................ 1

Pins for chin rest paper ................................................................................ 2

Printer paper (1 paper is installed in the main unit.) .................................... 2

Dust cover .................................................................................................... 1

Instruction manual (this manual) ................................................................. 1

Data Transfer installation CD ...................................................................... 1

Data Transfer Starting Guide ....................................................................... 1

1-5

1.3 Glossary
[6A]

Percentage of cell hexagonality.

Percentage of hexagonal cells in analyzed endothelium tissues

[AA/AS]

Auto Alignment / Auto Shot

[AA/MS]

Auto Alignment / Manual Shot

[AVG]

Average area
Average area of analyzed endothelium tissues

[Basic mode]

Capture mode in which the image selection screen appears when

capturing is completed.
This mode is for users to observe 16 captured images of endothelium
tissues and select only one from them.

[CCT]

Central corneal thickness

[CCT (US)]

Ultrasound correction for central corneal thickness

The reference value expected when measuring the same central corneal
thickness using our ultrasound-type central corneal thickness measuring
instrument

[CD]

Cell density
The number of analyzed endothelium tissues in 1 mm2

[Core method]

Analysis method to calculate values such as CD (cell density) by

extracting trace lines of cells referring to the center of the cell entered by
the physician

[CV]

Fluctuation coefficient
Fluctuation coefficient of areas of analyzed endothelium tissues. Value
calculated by dividing the standard deviation with the average area.

[D.A.AVG]

Average area of dark area

Average area of analyzed dark area

[D.A.CV]

Fluctuation coefficient of dark area

Fluctuation coefficient of the analyzed dark area. Value calculated by
dividing the standard deviation with the average area.

[D.A.Density]

Dark area density

The number of cells in 1 mm2 of the analyzed dark areas

[D.A.MAX]

Maximum size of dark area

The area of the largest cell in the analyzed dark area

[D.A.MIN]

Minimum size of dark area

The area of the smallest cell in the analyzed dark area

[D.A.NUM]

Number of dark areas

The number of analyzed dark areas

[D.A.Ratio]

Dark area ratio

Ratio of the dark area relative to the total area. The total area is the sum of
the analyzed dark area and the area of the analyzed endothelium tissues.

[D.A.SD]

Standard deviation of dark area

Standard deviation of the analyzed dark area

[DATA Transfer]

System to output the examination data obtained with our product as a file

1-6

[Dark area]

Black circle area to be observed by the specula microscope

[Dark area analysis]

Analysis method to calculate values related to the dark area (D.A.Density,

etc.) by automatically extracting dark areas from the captured image

[L-count method]

Analysis method to calculate values such as CD (cell density) according to

the area and cell center entered by the physician

[MA/MS]

Manual Alignment / Manual Shot

[MAX]

Maximum area
The area of the largest cell in the analyzed endothelium tissues

[MIN]

Minimum area
The area of the smallest cell in the analyzed endothelium tissues

[NUM]

Number of cells
The number of analyzed endothelium tissues

[Quick mode]

Capture mode in which the image selection screen does not appear when
capturing is completed.
This mode is for users who do not wish to observe 16 images of
endothelium tissues.

[SD]

Standard deviation
Standard deviation of the area of analyzed endothelium tissues

[TOMEY Link]

System for electronic medical records that controls the examination data
obtained with our products

[Auto Alignment]

Function to automatically align the sight in up/down/right/left/focus

directions

[Auto Shot]

Function to automatically capture an image when the sight in the

up/down/right/left/focus directions is optimized

[Auto Analysis]

Analysis method to calculate values such as CD (cell density) by

automatically extracting trace lines of cells on the captured image

[Power-save]

This is a function to automatically turn off the monitor when the instrument
is not operated for a specified time. Touch the monitor to return to normal
status.

[Touch Alignment]

Function to move the measuring head by touching the screen. This is used
for rough alignment.

[Manual Alignment]

Manual alignment

[Manual Shot]

To capture images manually

[Rx only]

This symbol on the label of this device states "Caution: Federal law
restricts this device to sale by or on the order of a licensed healthcare
practitioner."

1-7

1.4 Overview
This instrument is designed to observe and analyze corneal endothelium by capturing an
image of corneal endothelium tissues without making contact, analyzing the captured
image, and calculating data such as cell density. In addition, this instrument also measures
the central corneal thickness while capturing an image of corneal endothelium tissues.
The patient places their chin on the chin rest and looks into the fixation light in the capture
window. The instrument automatically starts fine alignment when the physician roughly
aligns the corneal center and captures an image. An image can be captured manually
using the joystick if a problem with the eyes makes automatic operation impossible.

1-8

2. NAMES AND FUNCTIONS

2.1 Physician's side
(1) LCD monitor and touch panel

Head

Displays screens. Touch displayed buttons to operate

the instrument.
The tilting angle of the monitor can be adjusted.

(1)

(2) Power lamp

Neck

(2)

The lamp stays lit while the power is turned ON.

(3) Chin rest up/down button

Press the button to move the chin rest up and down.

(3)
Base

(4)
(5)

(4) Joystick
Performs alignment.
Use the capture button on the top of the joystick when
capturing an image manually.

(5) Built-in printer

Thermal printer with automatic cutter. Prints the
examination data.

2-1

2.2 Patient's side

(1) Touch pen
(2)
(1)

(3)
(4)

Use this when selecting cells etc. The touch pen is

provided with a magnet and can be attached to the
side of the monitor.

(2) Forehead pad

Have the patient lightly apply their forehead to this
pad to fix their head while capturing an image.

(3) Capture window

Radiates light for capturing images and receives the
light reflected from the patients eye.

(4) Chin rest

Have the patient to place their chin on this rest.

2-2

2.3 Sides of the main unit

(1) Power socket
(1) (2) (3)

Connect the power cord here.

(2) Power switch

Turns the instrument on and off.

(3) Packing button

Pressing this button for 3 seconds moves the head to
a set position in preparation for packing.

(4) SD card slot

An SD card used to save the examination data is
inserted here.

(5) USB-H connector

Connect the video printer and external ID input device
here.

(6) USB-D connector (PICT)

Connect the Pict Bridge printer here.

(4) (5) (6) (7) (8) (9)

(7) USB-D connector (personal computer)

Connect the personal computer etc. here.

(8) LAN connector

Used for connection to Ethernet.

(9) Maintenance switch

Our maintenance personnel use this switch when
servicing the instrument.
Never touch this switch.

2-3

2.4 Screen
2.4.1 Basic structure and common items
(1)

(2)

(3)

Varies depending on
modes.

(4)

(5)

(6)

(1) Patient information button

Moves to the patient information input screen.

(2) Patient information field

Displays the ID and name of the patient.

(3) Version
Displays the version of the system.

(4) Database" button

Moves to the Patient List screen.

(5) Retake button

Touch and hold this button to delete the examination data of the selected patients eye and start capturing
another image.

(6) New button

Touch and hold this button to delete the examination data of both eyes and the patients information, and start
capturing an image.

2-4

2.4.2 Capture screen

(1)

(3)

(4) (5) (6) (7)

(8)

(2)

(1)

(2)

(14)

(9)

(10) (11)

(12) (13)

(1) Eye selection button

Displays which side (left or right eye) the head is placed. Touch this button to move the head right and left.

(2) Thumbnails
Displays the captured image of the endothelium and anterior chamber, and central corneal thickness.

(3) Alignment/capture setting

Displays the setting for alignment and capture.
AA/AS: Auto Alignment / Auto Shot
AA/MS: Auto Alignment / Manual Shot
MA/MS: Manual Alignment / Manual Shot

(4) Capture light setting

Displays the setting for the strength of light for capturing an image of the endothelium.
Auto: Brightness is automatically adjusted.
High: Maximum brightness
Low: Minimum brightness

(5) Auto Alignment ring

Displayed when Auto Alignment is ON.

(6) Focus indicator

Displays the distance between the head and the patient's eye.
-

Horizontal bars mean that the head is too far from the eye.
Vertical bars mean that the head is too close to the eye.

(7) Auto shot mark

Shown in auto shot mode.

2-5

(8) Alignment OK mark

Shown when alignment is optimum.

(9) Fixation light button

The preset fixation light position is shown on this button in orange.
Touch this button to open the Fixation Light screen.

(10) "Setup" button

Moves to the Setup screen.

(11) Analyze" button

Performs automatic analysis and moves to the R/L eye analysis screen.

(12) Head retreat button

The head retreats while this button is touched.

(13) ZoomIn button

Switches the image shown by the live camera from the anterior chamber to endothelium tissues.
This button appears in MS (Manual Shot) mode.

(14) Image selection button

Moves to the image selection screen.

2-6

2.4.3 Image selection screen

(1)

(2)

(3)

(4)
(5)
(6)
(7)

(8)

(9)

(1) Inspected eye

Displays which patients eye (right or left) corresponds to the displayed examination data.

(2) Exam Date-Time

Displays the date and time when capturing the image.

(3) Thumbnails
Displays 8 out of 16 captured images of the endothelium as thumbnails.
Images are numbered from 1 to 16 in the order of the capture quality.

(4) Image of anterior chamber

Displays the captured image of the anterior chamber.

(5) Fixation light position

Displays the fixation light position when the image was captured.

(6) Central corneal thickness

Displays the thickness in the center of the cornea of the captured image.

(7) Selected image display field

Displays 1 enlarged image out of 16 images of the endothelium selected for analysis.

(8) Next Page button

Recalls the remaining 8 captured images included in the next page.

(9) Exit button

Closes the image selection screen and returns to the capture screen.
The selected image is designated for analysis.

2-7

2.4.4 Analysis screen

a) R/L eye analysis screen
(1)

(4)

(2)

(7)

(1)

(3)
(5)
(6)
(8)

(9)

(10)

(11)

(14) (15) (16) (12)

(17)

(13)

b) Single eye analysis screen

(1)

(2)

(7)

(4)

(9) (1)

(3)
(5)
(6)

(10)

(11)
(11)
(21)
(21)

(18)
(14) (15) (16) (12)

(17)

(13) (20) (19)

(1) Eye selection button

Shows the selected eye (right or left) by color. Touch this button to move to the single eye analysis screen.

(2) ExamDate
Displays the date and time when capturing the image.

(3) Image of endothelium

Touching the image switches selection of the eye. The endothelium image of the selected eye is outlined with
a color frame.

2-8

(4) Photo/Trace/Area/Apex buttons

Photo: Displays the captured image of the endothelium.
Trace: Displays extracted trace lines on the image of the endothelium.
Area: Displays an endothelium image color-coded according to cell sizes.
Apex: Displays an endothelium image color-coded according to cell shapes.

(5) Image of anterior chamber

Displays a captured image of the anterior chamber.

(6) Fixation light position

Displays the fixation light position when the image was captured.

(7) Analysis method

Displays the analysis method used for the displayed analysis results.

(8) Edit mark

Shown when the result of automatic analysis is edited.

(9) Reliability mark

The reliability level for automatic analysis is displayed. Refer to 3.4.1 Auto Analysis for details of reliability.

(10) Analysis results

Displays the results of analysis of the displayed endothelium image.
Refer to 3.4.1 Auto Analysis for details of each analysis result.

(11) Central corneal thickness

Displays the thickness in the center of the cornea of the captured image.

(12) Tone button

Brightness and contrast of the captured image can be adjusted. Touching this button shows the image quality
adjustment bar. Brightness and contrast can be adjusted within the range from -2 to +2. Touch the Tone
button again to return to the original screen.

(13) Zoom button

Enlarges the image of the endothelium. Double-tap any point on the endothelium image while touching the
Zoom button. The image is enlarged by 100%, 200%, and 400% in this order, regarding the tapped point as
the center. When the enlarged image is displayed, the image moves so that the tapped point comes to the
center of the frame. Touch the Zoom button again to return to the original screen.

(14) Method button

Switches analysis methods.

(15) Trace Edit button

Opens the Trace Edit screen.

(16) Cell Select button

Opens the cell selection screen.

2-9

(17) Print/Export/Save buttons

Two buttons can be selected from Print, Export, and Save using the system setup function. Refer to
3.7.4 Connection & Print for the setting method.
- Print: Prints the displayed examination data.
- Export: Transfers the examination data to the personal computer.
- Save: Transfers the patient information and examination data to the database.

(18) R/L eyes button

Moves to the R/L eyes analysis screen.

(19) Dark Area button

Moves to the dark area analysis screen.

(20) Area (Polymegathism)

Distribution of cells according to their sizes is displayed using a histogram.

(21) Apex (Plemorphism)

Distribution of cells according to their shapes is displayed using a histogram.

2.5 Symbols used for marking

Refer to instruction manual.

ON (power)

OFF (power)

Type B applied part

Grounding (earth)

2-10

3. OPERATION PROCEDURES
3.1 Safety precautions
The power plug completely isolates the instrument from the commercial
power source. If there is a problem with the instrument, turn off the power
switch and disconnect the power plug. Install the instrument in a place where
this can be performed smoothly.

Install the instrument so that the user can use the system under optimal
conditions. Carefully connect the devices so that the wiring is not
disconnected unintentionally during operation, and does not hinder
operation of the instrument.

3.2 Preparation before use

3.2.1 Connections
a) Power code
Insert the connector of the power cord into the power socket on the side of
the main unit in the correct direction. Connect all three pins of the plug.

(Fig. 1)
b) External digital printer
Use only the specified printer and cables. Use a video signal cable or remote
cable to connect this instrument to a device conforming to IEC60601-1 or JIS
T 0601-1 or conforming to IEC60950-1 and with a power source isolated by an
insulated transformer.

Video printer
Insert the cable plug A (1) of the USB cable into the USB connector (2) on
the side of the main unit in the correct orientation.
Connect the other cable plug B (3) of the USB cable to the video printer.
Follow the instruction manual of the video printer for details on how to
connect the printer.

3-1

 PictBridge printer
Insert the cable plug B (3) of the USB cable into the USB connector (PICT)
(4) on the side of the main unit in the correct orientation.
Connect the other cable plug A (1) of the USB cable to the printer.
Refer to the instruction manual of the PictBridge printer for details on how to
connect the printer.
(1)
(3)

(Fig. 1)

(2) (4)

c) External ID input device

Plug the connector of the external ID input device (e.g. barcode reader, card
reader, keypad, and keyboard) into the USB-H terminal (1) on the side of the
main unit, checking the correct orientation.

(Fig. 1)

(1)

d) Connecting the personal computer

The network support system TOMEY Link (optional) or the inspection data
receiving software DATA Transfer (included in the package) is required for
data communication with the Machine.

Refer to the corresponding operation manual for installation, settings, and

operation of TOMEY Link and DATA Transfer.

Connection setting on the System Setup screen must be completed before

connecting TOMEY Link and DATA Transfer. Refer to 3.7.4 Connection &
Print for the setting method.

Be sure to make network settings under the consent of your network

administrator.

For LAN connection, be sure to connect the unit to a computer via a hub. The
unit does not work correctly of directly connected to a computer.

Connecting LAN cables

Prepare the following items.
- LAN cables (straight type, category 5 or higher)
- A network hub (A 100MHz switching hub recommended)
- A computer with TOMEY Link or DATA Transfer installed

3-2

: 2
: 1
: 1

(Wiring example)
LAN cable
Hub

Systems in clinic

LAN cable
This
instrument
EM-4000

Personal
computer

(Fig. 1)
3.2.2 Starting/shutting down the instrument
a) Startup
1)

Turn on the video printer and/or PictBridge printer if using them.

2)

Turn ON (|) the power switch of the EM-4000.

- The startup screen (Fig. 2) appears and then the capture screen
appears.
(1)

(Fig.1)

(Fig.2)

b) Shutdown
1)

Turn OFF (O) the power switch of the EM-4000.

- To pack the instrument, move the head to a specific storage position
with the packing button and then turn the power off. Refer to 2.3
Sides of the main unit for how to perform packing.

2)

When the video printer and/or PictBridge printer is connected, turn them
off.

3-3

3.2.3 Clearing the last examination data (preparation for a new patient)
The deleted examination data cannot be restored. Carefully check the data
before deleting it.

Be sure to touch the New button to delete the examination data for the
previous patient before capturing images for a new patient. Otherwise, the
data for the previous patient may be included.

This operation does not clear examination data saved in the database. Refer
to 3.6.2 Deleting examination data to delete the examination data in the
database.

1)

Touch the New button for a while.

- The patient information (ID, name, sex, and date of birth) and relevant
examination data is deleted, and the capture screen appears.

(1)
(Fig. 1)
3.2.4 Entering the patient data
When entering new patient information, carefully check that the same ID is
not registered in the database or other electronic medical records.

Only the first 14 digits of the ID number are displayed in the patient
information field. Check that the ID number is correct on the patient
information entry screen.

The network support system TOMEY Link (optional) is required to use the
patient information query function. DATA Transfer provided with the
Machine is not available for query of the patient data.

For details on the TOMEY Link Server settings, refer to the TOMEY Link
instruction manual.

Connection setting on the System Setup screen must be completed before

connecting with TOMEY Link. Refer to 3.7.4 Connection & Print for the
setting method.

Once examination data is output (printed, saved, or exported), the ID cannot

be changed.

1)

Touch the patient information button (1) to open the Patient Information
screen (Fig. 2).
- When both the patient information and examination data exist, a
Warning (Fig. 3) appears indicating you are about to overwrite data
when the patient information button is touched. Touch the Yes button
(7) to overwrite the data.

3-4

(1)

(Fig.1)
(2)
(3)
(4)
(5)
(6)
(Fig.2)
2)

(Fig.3)

(7)

Enter necessary data.

- Entry method 1: Software keyboard
Patient's ID, name, sex, and date of birth can be entered using the
software keyboard on the Patient Information screen (Fig. 2).
If the entered ID is already recorded in the memory, the corresponding
name, sex, and date of birth is automatically recalled from the memory
in the main unit when the ID is entered.
- Entry method 2: Database (SD card)
The patient can be selected from the list saved in the database (SD
card).
Touch the Patient Search button (2) on the Patient Information
screen (Fig. 2) to open the Patient List screen (Fig. 4). Touch the
desired patient in the list (8) and then the Select button (9).
- Entry method 3: Inquiry to TOMEY Link
Enter the ID and touch the Tomey Link Inquiry button (3) on the
Patient Information screen (Fig. 2). The patient information read from
TOMEY Link in the personal computer appears.
- Entry method 4: External ID input device
Data can be entered using a barcode reader, card reader, or keypad.
The barcode reader and card reader are also available on the capture
screen in addition to the Patient Information screen (Fig. 2)

(8)

(9)

(Fig. 4)

3-5

3)

Touch the OK button on the Patient Information screen (Fig. 2),

designate the patient information, and return to the previous screen.
- Touch the "Cancel" button (5) to discard the edited Information and
return to the previous screen.

3.2.5 Patient's eye height adjustment

When moving the head and/or chin rest, pay attention to the position of the
patient's face, hands, and fingers. Otherwise, they may be injured by the
movement of the head or chin rest.

The chin rest paper is provided to keep the chin rest clean. Use this paper for
the chin rest as well as the patient to use this instrument comfortably.

Peel off the top sheet of chin paper and clean the forehead pad with a clean
cloth before capturing images for the next patient. Clean the forehead pad
with a cloth dampened with alcohol as needed.

1)

Have the patient place their face on the chin rest (1). Adjust the chin rest
height so that the height of the corner of the eye is aligned with the eye
level mark (2). Press the chin rest button (3) at the front of the main unit
(Fig. 2) to move the chin rest up and down.

2)

When the patient's eye height is determined, lightly push the patient's
forehead against the forehead pad (4) to secure the patient's position.
(2)
(4)

(1)

(3)

(Fig. 1)

3-6

(Fig. 2)

3.2.6 Setting the fixation light position

The fixation light to fix the patients eye can be turned on in the center, 6
directions in the periphery, and 8 parafovea directions. The center light is
normally used for capturing images, but the peripheral and parafovea
positions are effective when an image cannot be taken with the light in the
center or when capturing an image at optional positions.
1) Touch the fixation light button (1) to display the Fixation Light screen (Fig.
2).

(2)
(1)
(3)
(Fig. 1)

(Fig. 2)

2 Touch the appropriate button (2) to select the lighting position.

- Descriptions on each button represent the direction viewed from the
patient.
C.: Center,

U.: Up,

R.U.: Upper right,

L : Bottom, L.L.: Lower left,

R.L.: Lower right,

L.U.: Upper left

3 Touch the Exit button (3) to close the Fixation Light screen.
- The position of the lit fixation light is shown in orange on the fixation
light button (1) on the capture screen.
3.2.7 Setting capturing conditions
Settings for capturing images can be changed temporarily. Temporary
settings made as described below will be initialized when the New button is
touched.
1 Touch the Setup button (1) to display the Setup screen (Fig. 2).

(1)

(Fig.1)
(2)

a)
b)
c)
d)
(Fig.2)

3-7

2Select the setting of each item using corresponding buttons.

- Setting items a) through d) will be described later.
3Touch the "Exit" button (2) to return to the capture screen.
a) Alignment
When Manual is selected for Alignment, Auto cannot be selected for
Shot."

Auto
Manual

The Auto Alignment function is active.

Alignment in up/down/right/left/focus directions is automatically
performed.
The Auto Alignment function is not active.
Use the Touch Alignment function or joystick to conduct
focusing.

b) Shot
Auto
Manual

c) Light Power
Auto
High
Low

The Auto Shot function is active.

An image is captured automatically when the sight in the
up/down/right/left/focus directions is optimized
The Auto Shot function is not active.
Use the capture button on the monitor or joystick button to
capture an image.
The power of the light for capturing an image of the
endothelium is adjusted automatically.
The power of the light for capturing an image of the
endothelium is set to the maximum level.
The power of the light for capturing an image of the
endothelium is set to the minimum level.

d) Measure Mode
Perform system setup to maintain the capture mode setting. Refer to 3.7.2
Measurement for the system setup procedures.

Quick

Basic

3-8

Capture mode in which the image selection screen

does not appear when capturing is completed. This
mode is for users who do not wish to observe 16
images of endothelium tissues.
Capture mode in which the image selection screen
appears when capturing is completed. This mode is for
users to observe 16 captured images of endothelium
tissues and select only one from them.

3.3 How to capture images

3.3.1 Selecting the eye to be measured
1Touch the eye selection button (1) on the capture screen.
(1)
(1)

(Fig. 1)
3.3.2 Alignment
Do not allow any person to place their hands or fingers in the clearance
between the head and neck or neck and base, or the section under the chin
rest. Their hands or fingers may be caught and injured.

The Auto Alignment function may not work correctly when eyelids and
eyelashes cover the pupils. Ask the patient to open their eyes wide or have
the physician lightly hold the patient's upper eyelid with their fingers.

Auto Alignment may not work correctly when the patient blinks frequently.
Ask the patient to stop blinking while capturing images.

Ask the patient to look at the fixation light. If the patient looks in a different
direction or moves, alignment may not be conducted correctly.

Auto Alignment is set as the standard setting to capture better images. In

some rare cases auto alignment cannot be performed because of a shortage
of reflection light due to deformation and/or inflammation of the cornea. In
this case, use manual mode.

a) Alignment using touch panel

When moving an element up, down, left and right using the touch panel,
touch the panel and release your finger immediately. Do not press the panel
continuously. Press the panel continuously when moving the element back
and forth.

1)

Display the patients eye.

- Operate the touch panel or the joystick to show the patient's eye on
the screen. (Fig. 1)

2)

Perform alignment in up, down, left, and right directions.

- Lightly touch the pupil center (1) of the patients eye displayed on the
screen. The head moves so the patient's eye is positioned in the
center of the screen.
- When the center of the pupil (1) approaches the center of target ring
(2) with Auto Alignment turned on, focusing in the up/down and
left/right directions automatically starts.

3-9

(1)
(2)

(Fig. 1)
3)

Perform alignment in front and back directions.

- Touch the center of the alignment mark (3) to move the head toward
the patient. Touch the head retract button (4) to retract the head
toward the physician.

(3)
(5)
(6)
(Fig. 2)
4)

(4)

When the cornea approaches the optimum alignment position, the focus
indicator (5) appears.
- A horizontal focus indicator means that the head is too far from the eye.
- A vertical focus indicator means that the head is too close to the eye.
- When Auto Alignment is active, focusing in the front-back directions
starts automatically when the cornea approaches the optimum
alignment position.

5)

When the optimum alignment position is found, the alignment OK mark

(6) appears.

b) Alignment using joystick

There are two types of operations - rough operation for moving the
head into rough position and fine operation for finely adjusting the
position of the head.
[Rough operation]
Moving the joystick moves the head
back, forth, left, and right.
When the up/down ring is slid up and
down, the head moves up and down.

(Fig.1)

3-10

[Fine operation]
Tilting the joystick moves the head in
the tilting direction.
Turn the up/down ring to move the
head up and down.
Clockwise : The head rises.
Counterclockwise : The head lowers.

(Fig.2)
1)

Operate the joystick to move the head so the center of the pupil (1)
appears in the center (2) of the target ring.

(1)

(2)

(Fig. 3)
2)

Move the joystick back and forth to perform alignment. When the cornea
approaches the optimum alignment position, the focus indicator (3)
appears.
- A horizontal focus indicator means that the head is too far from the
eye.
- A vertical focus indicator means that the head is too close to the eye.
- When Auto Alignment is set, focusing in the front-back directions
starts automatically when the cornea approaches the optimum
alignment position.

3)

When the optimum alignment position is found, the alignment OK mark

(4) appears.
(3)

(4)

(Fig. 4)

3-11

3.3.3 Capturing endothelium tissue image

Stop capturing images immediately if the patient shows any signs of
photosensitive epilepsy.

A good image of the endothelium tissues may not be captured, and the
analysis result or corneal thickness value may become unreliable due to
faulty fixing of the sight, eyelid drooping, trichiasis, corneal diseases, etc.
When the captured image is unclear, select or capture another image.

This instrument is designed to perform auto shot as the standard setting to

perform highly precise measurement.

In rare cases, a good image of the endothelium may not be taken due to
cornea deformation and/or corneal opacity. In this case, perform manual
operation.

a) Auto Shot
1)

No operation is required.
- Image is captured automatically when alignment has been completed.

2)

The following screen appears when capturing has been completed.

In Quick mode
- The capture screen (refer to 2.4.2) appears when an image of one eye
has been captured. Touch the eye selection button again to capture an
image of the other eye.
- The R/L eye analysis screen (refer to 2.4.4) appears when images of
both eyes have been captured.
In Basic mode
- The image selection screen (refer to 2.4.3) appears when capturing
has been completed.

b) Manual Shot
1)

After alignment is completed (refer to 3.3.2), touch the ZoomIn button

(1) on the capture screen (Fig. 1) or press the button on the joystick (2)
to display the live endothelium image (Fig. 3).
- Touch the ZoomOut button (4) on the live endothelium image screen
(Fig. 3) to return to the live anterior chamber image screen (Fig. 1).
(2)

(Fig. 1)

3-12

(1)

(Fig.2)

(Fig. 3)
2)

(3) (4)

Check the endothelium image to be captured on the live endothelium

image, and touch the Capture button (3) or press the joystick button (2)
to start capturing.
- If the capture position needs to be finely adjusted, operate the joystick
and adjust the position before touching the Capture button (2).

3)

The following screen appears when capturing has been completed.

In Quick mode
- Return to the capture screen (refer to 2.4.2) when an image of one
eye has been captured. Touch the eye selection button again to
capture an image of the other eye.
- The R/L eye analysis screen (refer to 2.4.4) appears when images of
both eyes have been captured.
In Basic mode
- The image selection screen (refer to 2.4.3) appears when capturing
has been completed.

3-13

3.3.4 Selecting image

Select an image to be analyzed from the 16 captured images of the
endothelium.
Touch the image selection button (1) on the capture screen (Fig. 1). The
image selection screen (Fig. 2) appears. In Basic mode, the image selection
screen (Fig. 2) appears every time an image of an eye is captured.

(3)
(1)

(Fig. 1)
1)

(2)

(Fig. 2) (6)

(3)

(4) (5)

Touch the thumbnail (2) of captured images to select the image to be

used for analysis.
- The selected image is displayed in the image display field (3) on the
left of the screen.
- If there is no appropriate image among the 8 images on the first page,
touch the Next Page button (3) to select the optimum image from the
8 images on the next page.
- If there is no appropriate image in the 16 images, touch and hold the
Retake button (4) to capture images again.

2)

When the endothelium image to be used for analysis is selected, touch

the Exit button (5) and return to the capture screen.
- The image selected at this time is designated for analysis.
- Touch the Analysis button (6) to open the R/L eye analysis
screen without returning to the capture screen.

3-14

3.4 Analysis
3.4.1 Auto Analysis
Auto Analysis is to calculate values such as CD (cell density) by automatically extracting trace lines
of cells on the captured image

Check that the trace line of cells is correctly detected on the captured image.
The trace line cannot be extracted on some images.

Perform any of the following operations if the trace line is not extracted
correctly.
- Retake
ure an image again if the images are not clear.
- Correcting trace line
Correct and redraw the incorrect images.
Refer to 3.4.1 Editing trace line for how to edit the trace line..
- Selecting cell
Exclude cells with trace lines extracted incorrectly from the target of analysis.
Refer to 3.4.1 c) Selecting cells for how to select cells.
- Changing analysis method
Perform analysis with the L-count method or Core method. Refer to 3.4.2 L-count
method and 3.4.3 Core method for the operation of the L-count method and Core
method.

a) How to recognize capacity data

R/L eye fracture screen
When touching the Analyze button on the capture screen or image
selection screen, the captured image is analyzed automatically and the R/L
eye analysis screen (Fig. 1) appears. In Quick mode, the image selection
screen appears when images of both eyes have been captured.
(1)

(Fig. 1)

3-15

 Single eye analysis screen

Touch the eye selection button (1) on the R/L eye analysis screen (Fig. 1).
The single eye analysis scren (Fig. 2) appears. Distribution according to cell
sizes and shapes is shown in a histogram on the single eye selection
screen.

(Fig. 2)
Checking analysis value
The displayed endothelium image is automatically analyzed and resultant
values are displayed on the R/L eye analysis screen and single eye analysis
screen.
Abbr
eviati
on
NUM

Item

Unit

Details

Pieces

CD

Number of
cells
Cell density

AVG

Average area

m2

SD

Standard
deviation
Fluctuation
coefficient

m2

Maximum
area
Minimum
area
Percentage
of cell
hexagonality.

m2

The number of analyzed endothelium

tissues
The number of analyzed endothelium
tissues in 1 mm2
The average area of analyzed
endothelium tissues
Standard deviation of the area of
analyzed endothelium tissues
Fluctuation coefficient of the area of
analyzed endothelium tissues
Value calculated by dividing the
standard deviation with the average
area.
The area of the largest cell in the
analyzed endothelium tissues
The area of the smallest cell in the
analyzed endothelium tissues
Percentage of hexagonal cells in
analyzed endothelium tissues

CV

MAX
MIN
6A

/mm2

m2
%

- A hyphen (-) is displayed for all analysis values if the cell trace line could
not be extracted by automatic analysis.

3-16

 Checking central corneal thickness

The measured central corneal thickness is shown on the R/L eye analysis
screen and single eye analysis screen.
Abbr
eviati
on
CCT
CCT
(US)

Analysis item

Unit

Details

Central
corneal
thickness
Ultrasonic
correction for
central
corneal
thickness

Central corneal thickness

The reference value expected when

measuring the same corneal thickness
using the ultra-sound corneal thickness
measuring instrument

- A hyphen (-) is shown in CCT and CCT (US) when CCT cannot be
measured.
- It can be set on the System Setup screen whether to show CCT (US) or not.
Refer to 3.7.3 Application" for setting method. The initial setting is OFF.
- CCT (US) is calculated by adding a specific thickness (offset value) to
CCT. The offset value can be changed on the System Setup screen.
Refer to 3.7.3 Application" for setting method. The initial setting is
13m.
Checking distribution according to sizes/shapes
Distribution according to cell sizes and shapes obtained by automatically
analyzing the displayed image of endothelium tissues is displayed using a
histogram on the single eye analysis screen.
- The class width of distribution according to cell sizes can be set on the
System Setup screen. Refer to 3.7.3 Application" for setting method. The
initial setting is 100 m2.
- If the cell trace line cannot be extracted correctly by automatic analysis,
neither a bar nor a number is displayed on the histogram.
Changing displayed image
The displayed endothelium image is automatically analyzed and resultant
images are displayed on the R/L eye analysis screen and single eye analysis
screen. Use the following buttons to change the image.
Abbrevi
ation
Photo
Trace

Area
Apex

Item

Details

Captured
image
Cell trace
line

Displays the captured image.

Area-speci
fic
Shape
specific

Displays trace lines of extracted endothelium tissue

in red.
The trace line of the dark area is shown in blue when
the dark area is extracted. Refer to 1.3 Glossary
for dark area.
Displays an endothelium image color-coded
according to cell area.
Displays an endothelium image color-coded
according to cell shapes.

3-17

- The image to be displayed immediately after automatic analysis can be

selected on the System Setup screen. Refer to 3.7.3 Application" for
setting method. The initial setting is Area.
Checking fixation light position
The position of the fixation light when capturing an image is shown on the R/L
eye analysis screen and single eye analysis screen with icons shown below.
- It can be set on the System Setup screen whether to indicate the position
for capturing an image with a black square on the icon. Refer to 3.7.3
Application" for setting method. The initial setting is OFF.
(1) Indication of fixation light position: OFF
Center

Parafo
va

45

90

135

180

225

Periph
eral

U.

L.U.

L.L.

L.

R.L.

R.U.

270

315

270

315

(2) Indication of fixation light position: ON

Center

Parafo
va

45

90

135

180

225

Periph
eral

U.

L.U.

L.L.

L.

R.L.

R.U.

Checking reliability
The displayed endothelium image is automatically analyzed and resultant
reliability is displayed on the R/L eye analysis screen and single eye analysis
screen. The reliability is categorized into 3 levels and indicated by the mark
corresponding to each level as listed below.
Reliability mark

Description

No mark

The reliability for automatic analysis is high because

cells are clearly captured over a wide range and cell
trace lines are extracted precisely by automatic
analysis.
Because the range of captured cells is slightly less or
visibility of captured images is slightly poor, some cell
trace lines are not extracted correctly by automatic
analysis and the resultant reliability is slightly lower.

3-18

Because the range of captured cells is small and

visibility of captured images is poor, cell trace lines are
not extracted correctly by automatic analysis and the
resultant reliability is low.

When e or E is displayed, perform any of the following actions according

to the captured image condition.
- Retake
Capture an image again if the images are not clear.
- Correcting trace line
Correct and redraw the incorrect images. Refer to 3.4.1 Editing
trace line for how to edit the trace line.
- Selecting cell
Exclude cells with trace lines extracted incorrectly from the target of
analysis. Refer to 3.4.1 c) Selecting cells for how to select cells.
- Changing analysis method
Perform analysis with the L-count method or Core method. Refer to
3.4.2 L-count method and 3.4.3 Core method for the operation of
the L-count method and Core method.
The reliability mark does not appear when the following analytical
calculations are conducted.
- When a trace line is edited
- When a cell is selected
- Analysis using the L-count method
- Analysis using the Core method
It can be set on the System Setup screen whether to show the reliability or
not.
Refer to 3.7.3 Application" for setting method. The initial setting is OFF.

Checking dark area analysis

Touch the Dark Area button (1) on the single eye analysis screen (Fig. 3).
The dark area analysis scren (Fig. 4) appears. Touch the Dark Area" button
(2) on the dark area analysis screen (Fig. 3) to return to the single eye
analysis screen.

(1)

(Fig. 3)

(2)

(Fig. 4)

3-19

The following analysis results obtained by automatically extracting dark

areas from the displayed image of endothelium are displayed on the dark
area analysis screen (Fig. 4).
- Dark area analysis image
Use the following buttons to change the image.
Abbre Item
Details
viation
Photo Captured Displays the captured image.
image
Trace
Cell trace Displays trace lines of extracted dark
line
areas..
Displays trace lines of endothelium tissue
in blue.
Area
Area-spe Displays the extracted dark area
cific
color-coded according to area sizes.
- Dark area analysis value
The analysis results of the displayed dark area in endothelium.
Abbrevi Item
Unit
Details
ation
D.A.NU Number of
Piec The number of analyzed dark
M
dark areas
es
areas
D.A.De Dark area
/mm2 The number of cells in 1 mm2
nsity
density
of the analyzed dark area
D.A.AV
Average area m2
Average area of analyzed
G
of dark area
dark areas
D.A.SD Standard
m2
Standard deviation of the
deviation of
analyzed dark area
dark area
D.A.CV Fluctuation
%
Fluctuation coefficient of the
coefficient to
analyzed dark area. Value
dark area
calculated by dividing the
standard deviation with the
average area.
2
D.A.MA Maximum size m
The area of the largest cell in
X
of dark area
the analyzed dark areas
D.A.MI
Minimum size m2
The area of the smallest cell
N
of dark area
in the analyzed dark areas
D.A.Rat Dark area
%
Ratio of the dark area size
io
ratio
relative to the total area. The
total area is the sum of analyzed
dark area and the area of
analyzed endothelium tissue.
- Distribution according to sizes of dark area
Distribution according to sizes of dark areas automatically extracted
is shown in a histogram.
Analysis in the dark area can be set to ON or OFF in the item Dark Area
Analysis on the System Setup screen.
- The initial setting is ON.
- The Dark Area button does not appear on the single eye analysis
screen if this item is set to OFF. Namely, the dark area analysis
screen (Fig. 3) cannot be called.

3-20

- Refer to 3.7.3 Application" for setting method.

b) Editing trace line
Trace lines of endothelium tissues extracted by automatic analysis can be
edited.
Edit marks appear on the analysis screen when the trace line is edited. Refer
to 2.4.4 Analysis screen for details of edit marks.
Touch the Trace Edit button (1) on the analysis screen (Fig. 1) to open the
Trace Edit screen (Fig. 2).

(Fig. 1)

(1)

(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(Fig. 2)

(11)

(12)

(10)

(2) Pencil button

Adds trace lines shown in red. Straight lines or curves are drawn as
traced on the image.

(Fig. 3)
(3) Eraser button
Deletes trace lines shown in red. Touch the line in the image to delete
it.

(Fig. 4)

3-21

(4) Analysis range selection button

Specifies the range to be analyzed. Specify an area to be analyzed by
selecting two opposing points in an area where the shape of the cell
can be confirmed.
When 100 m is set to "L-count range of the system setup items,
touch the center of the 100m-square frame. Refer to 3.7.3
Application" for the system setup.
(5) Whole range button
Pressing and holding this button specifies the whole range of the
image of the displayed endothelium tissues.
(6) All clear button
Pressing and holding this button deletes all trace lines of endothelium
tissues and dark areas currently displayed.
(7) Automatic selection button
Pressing and holding this button deletes all trace lines of endothelium
tissues and dark areas currently displayed, and then displays trace
lines of automatically extracted endothelium tissues and dark areas.
(8) Undo/Redo button
Returns or proceeds to the condition immediately before or after
respectively.
(9) Zoom button
Enlarges the image of the endothelium.
Refer to 2.4.4 Analysis screen for operation of this button.
(10) Dark Area button
Switches the trace lines to be edited. Touching this button changes the
target trace line (red) from the endothelium tissue to dark area. Touch
the button again to return the setting.
(11) Calc. (calculation) button
Performs calculation for analysis using the edited trace line and
returns to the analysis screen. Returns to the dark area analysis
screen when the "Dark Area button is activated.
(12) "Cancel" button
Returns to the analysis screen without applying the edited contents.
Returns to the dark area analysis screen when the "Dark Area button
is activated.
c) Selecting cells
Cells used for analysis can be selected from endothelium tissues extracted
by automatic analysis.
Edit marks appear on the analysis screen when cells are selected. Refer to
2.4.4 Analysis screen for details of edit marks.
Touch the Cell Select button (1) on the analysis screen (Fig. 1) to open the
Cell Select screen (Fig. 2). Selected cells are displayed in colors, and cells
not selected are displayed without color or in gray.
Touch a cell on the image of the endothelium to select it.

3-22

(Fig. 1)
(1)
(1)
(2)

(3)

(Fig. 2)

(4)

(1) All selection button

Selects all cells automatically extracted.
(2) All cancel button
Cancels selection of all cells automatically extracted.
(3) Undo/Redo button
Returns or proceeds to the condition immediately before or after
respectively.
(4) Calc. (calculation) button
Performs calculation for analysis using the edited trace line and returns
to the analysis screen. Returns to the dark area analysis screen when
the "Dark Area button is activated.
3.4.2 L-count method
The L-count method is an analysis method to calculate values such as CD (cell density)
according to the area and cell center entered by the physician
a) Switching to L-count method
1)

Touch the Method button (1) on the analysis screen to open the
Method screen (Fig. 2).

(1)
(Fig. 1)

3-23

(2)
(Fig. 2)
2)

Touch the L-count button (2) and then the OK button to open the
Point Edit (L-count) screen (Fig. 3).

b) Editing range and point

The L-count assist function is designed to help users operate points. Be sure
that the user themselves check points selected by the L-count assist
function before adding or deleting them.

Place a point according to the procedures below. Incorrect calculation

results may be shown if points are not selected correctly.

(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(Fig. 3)
1 Specify the range.
-

Touch the range selection button (4) to activate it. Touch two
opposing points of the area (rectangle) subject to calculation on the
image of the endothelium.

When 100 m is set to "L-count range of the system setup items,

touch the center of the 100-m-square frame. Refer to 3.7.3
Application" for the system setup.

The area of the specified range is shown in the Area field (3).

When L-count Assist in the system setup is set to ON, cells in the
selected range are simply extracted and dots appear on the cells.

2 Place a dot on a cell.

- Touch the cell selection button (5) to activate it. Specify the center of
all cells in the specified range using the touch pen.
- An orange dot appears at the touched point.
- The number of current dots appears in the "Count" field (3).

3-24

3)

To delete a dot, touch the eraser button (7) to activate it and then
touch the dot to be deleted.
Touching and holding the all delete button (6) deletes all dots
displayed.
Touch the undo/redo buttons (8) to undo and/or redo the operation to
specify dots.

Touch the Calc. (calculation)" button (9) to close the Point Edit screen.
- The calculation results are displayed on the analysis screen.
- Touching the "Cancel" button (10) will discard the edited point
information, and return you to the analysis screen.

The range line in the L-count method is shown in orange (solid line) and light
blue (dotted line).

To specify cells, point to cells of which trace lines are crossed with an orange
solid line. Do not point to cells if their trace lines are crossed with a light blue
dotted line.

(Fig. 4)
c) How to read analysis results

(Fig. 5)
Three analysis values (NUM, CD, and AVG) are calculated in the L-count
method. Analysis values are displayed on the analysis screen (Fig. 5).
A hyphen (-) is shown for analysis values other than NUM, CD, and AVG.
The analyzed image (Area, Apex) is not output.
Touch the Point Edit button and open the Point Edit screen to edit
points again.
When analyzing another eye by the L-count method, touch the image of
the endothelium to change the eye, touch the Point Edit button, and
then edit points on the Point Edit screen.

3-25

3.4.3 Core method

The Core method is an analysis method to calculate values such as CD (cell density)
by extracting the outline of the cell referring to the center of the cell entered by the
physician
a) Switching to Core method
1 Touch the Method button (1) on the analysis screen to open the
Method screen (Fig. 2).

(1)
(Fig. 1)

(2)
(Fig. 2)
2 Select the Core button (2). Touch the OK button to open the Point
Edit (Core Method) screen (Fig. 3).
b) Editing point
Be sure to observe the following precautions when specifying dots in the
Core method. Incorrect results may be displayed.

The number of points should be 50 or more. The recommended number of

points is 100 or more.

Point to the center of the cell as much as possible. The accuracy of analysis
results lowers as the point position deviates from the center.

Determine the range for pointing in advance and then specify the point in all
cells included in the determined range. If cells are not specified, the CD (cell
density) will be calculated as smaller than the actual value. It is
recommended to specify cells from the top center area to bottom center area,
and then the surrounding cells clockwise in order to specify all cells.

3-26

(3)
(4)
(5)
(6)
(7)
(8)
(9)
(Fig. 3)
1)

Place a dot on a cell.

- Touch the cell selection button (4) to activate it. Specify the center of
each cell using the touch pen.
- A green dot appears at the touched point.
- The Count field (3) increases the number of dots every time a cell is
specified.
- To delete a dot, touch the eraser button (5) to activate it and then
touch the dot to be deleted.
- Touching and holding the all delete button (6) deletes all dots
displayed.
- Touch the undo/redo buttons (7) to undo and/or redo the operation to
specify dots.

2)

Touch the Calc. (calculation)" button (8) to close the Point Edit
screen.
- The result of calculation is displayed on the analysis screen.
- Touching the "Cancel" button (9) will discard the edited point
information, and return you to the analysis screen.

c) How to read analysis results

The NUM value becomes smaller than the number of dots in the analysis
result of the Core method. Dots near the outermost circumference are not
used for analysis.

(Fig. 4)

3-27

The same analysis values as those by automatic analysis are calculated in

the Core method. Analysis values are displayed on the analysis screen (Fig.
4).
- The analyzed image (Area, Area, Apex) is not output.
- Touch the Point Edit button and open the Point Edit screen to edit
points again.
- When analyzing another eye by the Core method, touch the image of
the endothelium to change the eye, touch the Point Edit button, and
then edit points.

3-28

3.5 Export, Print, and Save

Two functions from Export, Print, and Save can be assigned to two buttons
provided at the bottom center of the analysis screen. Those functions are
assigned on the System Setup screen. Refer to 3.7.4 Connection & Print
for the setting method.

(Fig. 1)
Functions that may be assigned to a button are as follows.
Export

Print

Save

Save & Export

Print & Export

Print & Save

ALL (Export, Print, and Save)

3.5.1 Export
The network support system TOMEY Link (optional) or the inspection data
receiving software DATA Transfer (included in the package) is required for
data communication.

Refer to the corresponding operation manual for the TOMEY Link and DATA
Transfer settings.

Connection settings on the Setup screen must be completed in advance to

connect with TOMEY Link and DATA Transfer. Refer to 3.7.4 Connection &
Print for the setting method.

Data cannot be sent using some settings in the system related to entry of ID if
the ID number is not entered. Refer to 3.7.1 General for settings on the
System Setup screen.

It is recommended to send data after entering the ID number.

The data can be sent without ID numbers entered; however, the
corresponding patient may not be traced from the inspection file output from
DATA Transfer. When the data was sent without entering the ID number,
check the content of the inspection file immediately after sending the data,
and move and save the file in an appropriate location. In addition, when data
was sent to TOMEY Link, all data without an ID number is regarded as data of
the same patient so that they must be handled with great care to avoid
mishandling.

3-29

1)

Touch the Export button (1) to display the Confirmation screen (Fig. 2).

(Fig. 1)

(1)

(3)

(2)
(Fig. 2)
2)

The transfer confirmation screen (Fig. 2) displays patient ID, name, sex,
and date of birth. Touch the "Export" button (2) to start sending data.
- Touching the "Cancel" button (3) returns you to the previous screen
without sending data.

3-30

3.5.2 Print
Touch the Print button to start printing from the built-in printer, video printer,
or PictBridge printer.
Select the desired printer in the system setup. Refer to 3.7.4 Connection &
Print for the setting of the printer.
a) Example of printout from built-in printer
The printing format for the built-in printer can be selected in the system setup.
Refer to 3.7.4 Connection & Print for the setting of printing format.

(1) Examination date/time

(1)
(2)
Header

(2) Model name; version

(3) Patient ID

(3)
(4)
(5)

(4) Patient's name

(5) Sex
(6) Eye (R/L)

(6)
(7)

(7) Fixation light position

(8) Image of endothelium
(9) Analysis method
(10) Edit mark
(11) Reliability mark
(12) Analysis results

(8)

(9)
(10)

(11)

(12)

3-31

(13)

(13) Central corneal thickness

(14)

(14) Ultrasonic correction for

central corneal thickness
(15) Dark area analysis value
(16) Dark area analysis setting
(D) : Dark area analysis ON
(A) : Analysis as endothelium ON

(15)

(17) Printing date/time

(18) Character string defined by
user
(16)
Footer

(17)
(18)

b) Printout from video printer

The monitor screen is printed from the video printer and PictBridge printer.
Buttons provided at the bottom of the screen are not printed.

3-32

3.5.3 Save
Always enter the ID number before saving the examination data.
Turn off the instrument when inserting or removing the SD card. Inserting or
removing the SD card while the instrument is on may damage the saved data.

The data saved in the SD card may be damaged due to SD card corruption or
instrument failure. Backup the data as necessary.

Touch the Save button (1) on the analysis screen to save the examination data
of both eyes to the database (SD card inserted in the base of the main unit).

(Fig. 1)

(1)

(Fig. 2)

The used storage capacity of the SD card is shown in % on the Save button
(Fig. 2).
If the used storage capacity of the SD card exceeds 90%, the character
color turns red. Use this indication as a reference for replacement of the
card.

3-33

3.6 Database
3.6.1 Browsing examination data
1)

Touch the Database button (1) on the analysis screen to open the
Patient List screen (Fig. 2).

(Fig. 1)

(1)
(2)
(3)

(4)

(6)
(5)

(Fig. 2)
2)

Touch the patient list window (3) to select the patient.

- The selected line turns black.
- Enter a search string into the search box (2). Possible patients are
found from the patient IDs and names in the database, and listed in
the patient list window.
- Touch any of the titles at the top of the patient list window (ID, Name,
and Date of birth) to sort patients.
- Touch the patient information button (4) to open the Patient
Information screen and check details of the patient information.
- Touch the "Exit" button (6) to return to the previous screen.

3)

Touch the Exam List button (5) to open the Exam List screen (Fig. 3) of
the selected patient.

(7)

(Fig. 3)

3-34

(9)
(8)

4)

Select the data to be browsed using the View 1 or View 2 button.

- The examination data selected by the View 1 or View 2 button is
shown on the left or right side of the R/L eye view screen respectively.
- Touch the "Exit" button (9) to return to the Exam List screen.

5)

Touch the View button (8) to display the selected examination data on
the R/L eye view screen.
- Functions of the buttons on the R/L eye view screen are the same as
those on the R/L eye analysis screen. Refer to 2.4.4 Analysis screen
for operation of the buttons on the R/L eye analysis screen.
- Edit the analysis result and touch the Save button (10) to overwrite
the existing examination data with the edited contents.
- Touch the "Exit" button (11) to return to the Exam List screen.

(Fig. 4)

(10)

(11)

3.6.2 Deleting examination data

When the patient information is deleted, all examination data saved with that
patients ID will be deleted. Be sure to check the contents saved before
deleting them.

a) Deleting data on Patient List screen

-

Touch the delete button (1) to delete the selected patient ID and
captured images.
Touch the all clear button (2) to delete the data in the database (all
patient information and examination data saved in the SD card).

(1)

(2)
(Fig. 1)

3-35

b) Deleting data on Exam List screen

-

Touch the delete button (1) to delete the captured image data selected
by the View 1 and View 2 buttons.
Touch the all clear button (2) to delete all examination data of the
selected patient. The patient information is not deleted.

(2)
(1)
(Fig. 1)

3-36

3.7 System setup

The system setup function is provided in this instrument to change various
settings. System setup settings are retained even when the instrument is
turned off.
1)

Open the System Setup screen. Touch the System Setup button (1) on
the Setup screen (Fig. 1) to open the System Setup screen (Fig. 2).
(4)

(3)

(2)

(1)
(Fig. 1)
2)

(Fig. 2)

The system setup consists of 4 major categories.

General .. Language, time, version information, etc.

Measurement Capture of images and operation
Application . Analysis and correction
Connection & Print Connection and printing
Touch the menu tab (2) to open the corresponding setup
screen.
The setup screen has a tree configuration. The displayed
location is shown in the address bar (3) and you can jump to
the specified screen by touching the displayed characters.
Touching the Exit button (4) will reflect the changes made and open the
capture screen.
3.7.1 General
Set general settings for the instrument. Select the General tab.

(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)

(Fig. 1)
(1) System Ver.
Displays the version of the system.

3-37

(2) Language
Selects the language.
(3) Date & Time
Set the display format of the date and the date and time. The key pad
appears when the input field is touched.
(4) Sound
Set whether to emit sounds when capturing an image and operating the
screen.
(5) Power Saving (auto power off function)
Automatically turns off the monitor when no operation is performed for a
specified time. Touch the monitor screen to return to normal status. Set
the time until the auto power off function is activated.
5 mins / 10 mins / OFF
(6) Brightness (monitor)
Set the brightness of the monitor screen.
(7) Machine No. Setting
Set the number to identify each instrument when multiple instruments of
the same model are installed.
(8) ID
Opens the System Setup screen (Fig. 2) for patient IDs.

(9)
(10)
(11)
(12)

(Fig. 2)
(9) ID Necessity, Save/Export
Set how the ID must be handled when saving and sending examination
data to TOMEY Link.

3-38

Indispe
nsable

Select this when ID numbers are always required.

Data cannot be saved or sent when the ID is not
entered.

Yes

Select this when the ID is usually entered, but data can

also be saved and sent without entering the ID. Data is
saved and sent with the ID as No ID when the ID is not
entered.

No

Select this when entry of the ID is optional. The

transfer confirmation screen appears, but the inspection
data is automatically saved and sent. Data is saved
and sent with the ID as No ID when the ID is not
entered.

(10) ID INPUT
Set whether to display the patient information input screen before
capturing images when starting to capture images for a new patient.
Yes

Opens the patient information entry screen before

capturing images.

No

Opens the capture screen.

(11) Input Mask

Sets which part of the character string should be recognized as the ID
number when entering the ID number from a barcode. If it starts from 0
or 1, the characters from the very beginning are identified as the ID
number.
(12) Confirmation
Select whether to open the patient information confirmation screen
when saving or sending the examination data to TOMEY Link.
3.7.2 Measurement
Make settings related to capturing images. Select the Measurement tab.

(1)
(2)

(Fig. 1)
(1) Measurement mode
Sets the mode for capturing images.
Quick : Capture mode in which the image selection screen does
not appear when capturing is completed. This mode is for
users that do not need to look at all 16 images of the
endothelium tissues.
Basic
: Capture mode in which the image selection screen
appears when capturing is completed. This mode is for
users who want to look at all 16 captured images of the
endothelium tissues and select only one from them.
(2) Joystick
Activates or deactivates the joystick.

3-39

3.7.3 Application
Make settings related to display and analysis. Select the Application tab.

(1)

(Fig. 1)
(1) Fixation
Sets whether to show the fixation light position for capturing images on
the fixation light position of the analysis screen.
a) CCT
Touch the Setting button (1) of CCT to display the System Setup screen
(Fig. 2).

(2)
(3)

(1)

(Fig. 1)

(Fig. 2)

(2) CCT (US) Display

Sets whether to display the ultrasound correction value of the central
corneal thickness.
The initial setting is OFF.
(3) CCT (US) Offset
Sets the offset for ultrasound correction of central corneal thickness.
Initial setting
13 m

Setting range
0 m - 30 m (in increments
of 1 m)
This item is not displayed when (2) CCT (US) Display is set to OFF.

3-40

b) Auto Analysis
Touch the Setting button (1) of Auto Analysis to open the System Setup
screen (Fig. 2).

(2)
(3)
(4)
(5)
(6)
(7)

(1)

(Fig. 1)

(Fig. 2)

(2) Analysis result

Sets images (Photo, Trace, Area, or Apex) to be shown immediately
after analysis is completed.
(3) Reliability
Set whether to display the reliability mark on the screen.
(4) Histogram Range
Set the range displayed by a histogram of area-specific distribution.
Initial setting
100 m2

Setting range
1 - 999 m2 (in increments of
1 m2)
(5) Dark Area Analysis
Turns the dark area detection function on and off.
Dark areas are not detected when set to OFF.
(6) Dark Area as Cell
Sets whether to regard detected dark areas as endothelium tissues and
include them in analysis of endothelium tissues. This item is not
displayed when (5) Dark Area Analysis is set to OFF.
(7) Analysis Area
Sets how to specify the range using the analysis range selection button
of the auto analysis/edit trace line function.
Variable
Set the analysis range by specifying two opposing
points.
100 m
Set the analysis range to 100 m2 regarding a point
specified on the image of endothelium tissues as the
center.

3-41

c) L-count Method
Touch the Setting button (1) of L-count Method to open the System
Setup screen (Fig. 2).

(2)
(3)
(1)

(Fig. 1)

(Fig. 2)

(2) L-count Area

Sets how to specify the range for analysis by the L-count method.
Variable
Set the analysis range by specifying two opposing
points.
100 m
Set the analysis range to 100m2 regarding a point
specified on the image of endothelium tissues as the
center.
(3) L-count Assist
Turns the L-count assist function on and off.
Cells are automatically selected after the range is specified when set to
ON.
d) Core Method
Touch the Setting button (1) of Core Method to open the System Setup
screen (Fig. 2).

(2)

(1)
(Fig. 1)

(Fig. 2)

(2) Histogram Range

Set the range displayed by a histogram of area-specific distribution.
Initial setting
100 m2

Setting range
1 - 999 m2 (in increments of 1 m2)

3-42

3.7.4 Connection & Print

Make settings related to connection, saving, export, and printing on this
screen. Select the Connection & Print tab.
a) Select Function
Touch the Setting button (1) of Select Function to open the Select
Function screen (Fig. 2).

(1)

(2)

(Fig. 1)

(Fig. 2)

(2) Select Function

Select functions of two buttons at the bottom center of the analysis
screen (Fig. 3).

(Fig. 3)

((Button 1) (Button 2)

b) Printout
Touch the Setting button (1) of Printout to open the System Setup screen
related to printers (Fig. 2).

(2)
(1)

(Fig. 1)

(Fig. 2)

3-43

(2) Printer Selection

Select the printer to be used. Three types of printers are available:
built-in printer, video printer, and PictBridge printer.
When the printer is selected, printer-specific setting items appear. There
are no special setting items for the PictBridge printer.

3-44

[Built-in]

(1)
(2)
(3)
(4)
(Fig. 1)
(1) Header/Footer
Set the items to be printed in the header and footer area.
Refer to 3.5.2 a) Example of printout from built-in printer for details of
printing items.
(2) Reliability
Set whether to show the reliability mark.
(3) Dark Area
Set whether to print the dark area analysis values.
(4) Line Spacing
Set the line spacing for printing.
[Video]

(1)

(Fig. 1)
(1) Video Printer
Select the type of video printer.
Four types of video printers are available as follows.
CP900D
Mitsubishi CP900D, color

CP30D
Mitsubishi CP30D, color

P93D
Mitsubishi P93D, monochrome

P95D
Mitsubishi P95D, monochrome

c) PC
Make connection settings to export data to a personal computer with TOMEY
Link or Data Transfer installed.
Touch the Setting button (1) of PC to open the System Setup screen
related to PC (Fig. 2).

3-45

(2)
(4)
(5)
(6)

(1)

(3)

(7)
(Fig. 1)

(Fig. 2)

(9)

(8)

(2) Connection permission and selection of cable type

LAN
Use a LAN cable for connection.

When LAN is selected here, all items listed on

this screen need to be set.
USB
Use a USB cable for connection.

Disable
Not connected

The initial setting is Disable.

(3) Auto Inquiry
T-Link
Database

The patient information corresponding to the

entered ID is retrieved from TOMEY Link.
The patient information corresponding to the
entered ID is retrieved from the database in the
SD card of the main unit.

(4) Login
Set the user ID and password to log in to the TOMEY Link. Maximum
number of characters to be entered for the user ID or password is 16.
(5) Host IP address
Set the IP address of the personal computer to be connected. This item
is displayed only when LAN is selected. Touch the DNS button to
specify the personal computer name. A DNS server must be running in
the LAN environment to enable connection using the DNS.
Touch the input field to display the keyboard.
(6) My IP Address Setting
Selects either DHCP (dynamic IP) or MANUAL (static IP) in the IP
Setting Type. When Manual is selected, set My IP Address, Sub Net
Mask, and Default Gateway.
This item is displayed only when LAN is selected in item (2).
(7) Port number
A port number can be set. This item is displayed only when LAN is
selected in item (2).
Initial setting
80

Input range
0 - 65535

(8) "Connection Test" button

Performs a connection test.
(9) Output Setting button
Open the System Setup Output Setting screen (Fig. 3).

3-46

(10)
(11)

(Fig. 3)
(10) "Dual" button
Set whether or not to output the JPEG image on the R/L eye analysis
screen to the personal computer.
(11) Single button
Set whether or not to output the JPEG image on the single eye analysis
screen to the personal computer.

Example

When only this instrument and the Tomey Link Server or a

computer running Data Transfer are connected to the
network, the following settings can be used.

1) Check the computer IP address.

Check and record the IP address and subnet mask of the computer with DATA
Transfer installed. Refer to the DATA Transfer operation manual for details.
2) Set settings on the Instrument.
The settings shown in the table below describe an example when the IP
address of the computer with DATA Transfer installed is 192.168.2.128" and
the subnet mask is 255.255.255.0. The IP setting method in this case is
Manual.
Instrument settings
192
168
2
129
(Local)
Same value as
Check these on the DATA Transfer
IP address
(1)
screen.
computer setting
255
255
255
0
255
255
255
0
Subnet
Same value as computer
Check these on the DATA Transfer
mask
screen.
setting
0
0
0
0
Default
------gateway
All 0
192
168
2
128
Host IP
------address
IP address of computer
*1: An arbitrary number from 1 to 255 excluding numbers used by the computer
(128 in this example)
192

Computer settings
168
2
128

3-47

d) Database
Touch the Setting button (1) of Database to open the System Setup
screen related to the database (Fig. 2).

(1)
(2)
(1)

(Fig. 1)

(Fig. 2)

(1) SD card - Format

Format the SD card inserted in the main unit. All examination data is
deleted.
(2) Exam List View
Normal
Displays thumbnails of images of the endothelium on
the Exam List screen.
Simple
Doesnt display thumbnails of images of the
endothelium on the Exam List screen.

3-48

This page is intentionally left blank.

3-49

4. INSPECTION AND MAINTENANCE

4.1 Warranty
One-Year Limited Warranty
The seller warrants this product to be free from defects in material and workmanship under
the normal use of this product for one (1) year or other term complying with local
regulations from the date of invoice issued by Seller to the original purchaser.
Lamps, paper and other consumable items shall not be covered by this warranty.
This warranty also shall NOT apply if the product has not been installed, operated or
maintained in accordance with the INSTRUCTION MANUAL of Tomey Corporation (here
in after called Tomey). Neither seller not Tomey shall be liable for any damages caused
by purchaser's failure to follow instruction for proper installation, use and maintenance of
product.
This warranty is only applicable to the new product and DOES NOT cover any damage
resulting from or caused by accident or negligence, abuse, misuse, mishandling, improper
modification of this product, by persons other than personnel duty authorized by Tomey,
not to a product whose serial number or batch number is removed, altered or effaced.
THIS WARRANTY IS EXPRESSLY IN LIEU OF ANY AND ALL OTHER WARRANTIES,
EXPRESSED OR IMPLIED (INCLUDING SPECIFICALLY, WITHOUT LIMITING THE
GENERALITY OF THE FOREGOING,
ALL WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR
PURPOSE), AND ALL OTHER OBLIGATION AND LIABILITY ON THE PART OF SELLER
AND TOMEY. NEITHER SELLER NOR TOMEY SHALL BE LIABLE FOR INCIDENTAL,
CONSEQUENTIAL OR SPECIAL DAMAGES UNDER ANY CIRCUMSTANCES OR FOR
MORE THAN REPAIR,
REPLACEMENT OR REFUND OF THE PURCHASE PRICE OF DEFECTIVE GOODS.

4-1

4.2 Operation life

This instrument is designed to have an operation life of 8 years when operated under the
appropriate environment and it is adequately inspected and serviced.

4.3 Inspection
When there is a problem, measurement may not be performed correctly.
Contact TOMEY or our local distributor immediately for repair.

When measuring the imitation eyes, check that there is no dust or stain on
them.

To make sure that the internal functions operate correctly and performance
is maintained, use the imitation eyes to check the accuracy before using the
instrument.
Inspect method Use the chin rest pins to fix the imitation eyes to the chin rest.
Perform measurement in the same manner as measuring a patient's eyes.
Check that the measured values are within the range specified on the
imitation eyes.

4-2

4.4 Routine maintenance

Hold the plug when disconnecting the power plug from the outlet to avoid
placing excessive force on the cord. Pulling the cord may damage the inner
core wires, resulting in electric shock or fire.

Do not use organic solvents such as thinner, benzene, or acetone to clean

the instrument. These solvents may damage the surface of the instrument.

Clean the inner surface of the capture window with a soft cloth from time to
time. High quality images may not be captured if the optical section of the
instrument becomes dirty.

Place the dust cover over the main unit when not being used.
Disconnect the power plug from the outlet and place the dust cover over the
main unit when not used for long periods.

Spray glass cleaner onto a soft cloth to clean the monitor on the main unit.
Gently wipe (do not rub) sections that patients touch directly, such as the
forehead pad and chin rest, with cotton dampened with alcohol.

Do not leave any water, chemicals, etc. remaining on the touch panel as the
surface of the touch panel is vulnerable to moisture. The surface of the touch
panel may be damaged and unable to maintain the appropriate performance.

Daily maintenance
Main unit
Gently wipe the surface using a soft cloth dampened
and thoroughly wrung out, and then wipe the surface
using a dry cloth.
Touch panel
Wipe the touch panel using a soft, dry cloth.
For heavy dirt
Main unit

Touch panel

Remove dirt from the surface by gently rubbing it using

a cloth dampened with diluted neutral detergent and
thoroughly wrung out.
Then, remove detergent from the surface using a cloth
dampened and thoroughly wrung out, and wipe the
surface using a dry cloth.
Remove dirt by lightly wiping the touch panel using a
soft cloth dampened with alcohol. Further, wipe it
using a dry soft cloth to completely remove moisture.

4-3

4.5 Replacing consumables

4.5.1 Fuses
Disconnect the power cord from the outlet when replacing fuses. Otherwise
you may get an electric shock, resulting in death or serious injuries.

Use fuses specifically designed for this instrument.

When the instrument does not work correctly after fuses have been replaced,
there may be other causes of the problem. Turn off the instrument
immediately and contact our local distributor.

1)

Turn power off and disconnect the

power plug from the outlet.

2)

Disconnect the power plug from the

power terminal.
Insert a flat screwdriver or coin into the
slot on the fuse case located at the
bottom of the main unit. Turn the screw
counterclockwise to remove it.

(Fig.1)

3)

Replace the blown fuse with a new one.

4)

Install the fuse holder in the reverse

order of removal.

4.5.2 Built-in printer paper

Always use genuine TOMEY paper for the printer. Using other types of paper
may cause printer failure.

Do not pull paper forcibly. Trying to pull the paper out may cause printer
failure. Touch the "PRINT" button without any data stored to feed blank
paper.

Replace the paper roll according to the procedure below when red lines
appear on the edges of the printer paper.
1)

(1)

(Fig.1)

4-4

Push the latch (1) on the printer cover

upward to open it.

2)

Remove the old printer paper roll and

install a new roll. If the roll is installed in
the wrong direction, nothing will be
printed.

3)

Close the printer cover with the end of

the paper protruding 2cm from the
outlet. Press the cover firmly until you
hear a click.

(Fig.2)

4-5

4.6 Storing
Install the instrument in a location free of water or chemicals. Any water or
chemicals entering the instrument may cause an electric shock or failure.

Do not store the instrument in a location where chemicals are stored or gases
may occur. Spilt chemicals or vapor may enter the instrument and result in
fire.

Disconnect the power plug from the outlet to ensure safety when the
instrument is not operated for long periods.

Store the instrument in a location not subject to direct sunlight, high

temperature and humidity, or air containing dust, salt and/or sulfur.
Otherwise, failure or malfunction may occur.

Store the instrument in a leveled stable place free of vibration or mechanical

impact. Otherwise, images cannot be captured correctly. The instrument may
also topple over or fall down, resulting in fire or a fatal accident.

Place the dust cover over the main unit when not being used. High quality
images may not be captured if the optical section in the instrument becomes
dirty.

Completely lower the head to the lower dead center when storing the
instrument.
Pressing the packing button (1) for 3 seconds automatically returns the head
to the lower dead center. Turn power off.

(1)

<Storage conditions>
- Ambient temperature range
- Relative humidity range

:
:

-20 - +60C
10 - 95%

4.7 Disposal
Keep the box and packing materials for use when moving or transporting the
instrument.

Keep the packing materials and the box together.

When disposing of the main unit and/or packing materials, sort them by
material type and abide by local government rules and regulations.

A lithium battery is used in the instrument. Handling of the lithium battery

varies depending on governing bodies. Follow relevant laws and local rules
and regulations, or contact our local distributor or representative.

4-6

5. TROUBLESHOOTING
Check the following first when you encounter any problems.
If the problem is not solved even after checking the applicable item listed below, contact
our local distributor to request inspection and/or repair.

Do not remove the cover of the instrument. You may be directly exposed to
high voltage sections.

Do not take any actions other than those specified below.

5.1 Common items

The instrument does not start when the power switch is

turned on.
Problem with the power plug
Check that the power plug is firmly connected to the
outlet. Check that there are no flaws in the power cord,
such as cracks or tears.
Problem with the power outlet
Check that power is supplied to the outlet to which the
power cord is connected.
Blown fuse
Check that fuses are not blown. If blown, replace the
fuse (refer to 4.5.1 Fuses). When the new fuse is
blown again, the instrument may be faulty. Contact
our local distributor to request inspection and/or
repair.

Nothing appears on the monitor screen.

The auto power off function, which automatically turns
off the screen when the instrument is not operated for
the specified time, has been activated.
Touch the monitor screen.
The maintenance switch on the side is in the P (up)
position.
Turned off the power, return the maintenance switch
to the down position, and then turn on the power.

5-1

The whole monitor screen is dark and not easy to see.

The brightness of the monitor is low.
Adjust the brightness of the screen using the
brightness setting of the screen described in "3.7.1
General."

The data cannot be printed by the video printer.

Printer paper.
Check the remaining printer paper. Verify that
printer paper is correctly set as described in the
instruction manual of the video printer.
USB cable.
Verify that the USB cable is correctly connected to
the main unit and the video printer. Refer to 3.2.1
Connections" for correct connection.
Setting the output printer
Set "Video" for the output destination when the
Print button is touched. Refer to 3.7.4 Connection
& Print for the correct setting.

The brightness and color of printouts from the video printer

are remarkably different from that of the screen display.
Setting of the video printer is not appropriate.
Adjust the contrast, brightness, and color as
described in the instruction manual of the video
printer.

The data cannot be printed by the built-in printer.

Printer paper.
Check the remaining printer paper. Verify that
printer paper is set correctly as described in "4.5.2
Built-in printer paper."
Setting the output printer
Set "Built-in" for the output destination when the
Print button is touched. Refer to 3.7.4 Connection
& Print for the correct setting.

5-2

The printer cover is open.

Check that the printer cover is completely closed.
The printer paper is not set in the correct direction.
Check that the printer paper is set correctly. Refer to
4.5.2 Built-in printer paper for the correct setting.

A different button to the one touched on the touch panel

becomes active.
The touch panel is not calibrated correctly.
Contact our local distributor.

Nothing is displayed on the screen of this instrument when

inputting IDs from the external ID input device.
USB cable.
Verify that the USB cable of the external ID input
instrument is correctly connected to the main unit.
Refer to 3.2.1 Connections" for correct connection.
A screen which does not receive an ID input appears.
Open the screen that receives the external ID input
device and then input IDs.
Refer to 3.2.4 Entering the patient data for the
screen that receives the external ID input device.

Data cannot be saved in the database.

The ID is not entered.
The instrument uses the ID as a file name. Enter the
ID and then save the data.
There is not enough space available in the SD card.
(The confirmation screen appears when attempting to
save the data.)
Delete unnecessary data in the SD card and save
the data again.

5-3

Communication with TOMEY Link or DATA Transfer cannot

be performed properly.
Cable is not connected properly.
Check that the connectors of the instrument and/or
connected device are plugged in properly.
TOMEY Link or DATA Transfer is not running.
Check that TOMEY Link or DATA Transfer (including
the relay software when connected via USB) is
running correctly. Refer to the instruction manual of
TOMEY Link or DATA Transfer for details.
TOMEY Link or DATA Transfer is in an error state.
Check that no error is current in TOMEY Link or
DATA Transfer (including the relay software when
connected via USB). Refer to the instruction manual
of TOMEY Link or DATA Transfer for details.
The HUB is not turned on (in the case of LAN
connection).
Turn on the HUB.
The instrument or TOMEY Link or DATA Transfer
settings are not correct.
Refer to 3.7.4 Connection & Print and make
correct settings.

5-4

6. CONSUMABLES AND OPTIONAL EQUIPMENT

The following spare parts and accessories are available from our local
distributor of this instrument. Contact our local distributor to order them.

Built-in printer paper

Specify the paper type as "TOMEY common printer (58 mm)."
Chin rest paper (100 sheets/set)
Fuse
Specify the fuse type as "Fuse for EM-4000."

6-1

This page is intentionally left blank.

6-2

7. Specifications
7.1 Specifications
7.1.1 Capturing scope
0.250.54mm (W x H)
7.1.2 Central corneal thickness measurement accuracy
10m
7.1.3 Central corneal thickness measurement range
300 - 1000m
7.1.4 Main unit
Display 10.4 color LCD
Dimensions and weight 309 (W) x 491 (D) x 450 (H) mm, approx. 22 kg
Voltage 100 V AC - 240 V AC
Frequency 50/60Hz
Consumption power 100 VA

7.2 Operating environment

Operate the instrument under the following environmental conditions.
Installation
Indoors, not in direct sunlight
Temperature
+10C - +40C
Humidity
30 - 75%
Atmospheric pressure 800 - 1060hPa
Power fluctuation
less than 10% of normal voltage
Store the instrument under the following environmental conditions.
Temperature
-20C - +60C
Humidity
10 - 95%
Transport the instrument in the instruments box under the following environmental conditions.
Temperature
-20C - +60C
Humidity
10 - 95%

7.3 Classification
Protection against electrical shockClass I ME equipment
Applied parts
B applied parts (Forehead pad, Chin rest)
IP Code
IP10
Mode of Operation Continuous operation

7-1

7.4 Declaration of Conformity to EMC

Caution: Medical electrical equipment.
EMC (Electro Magnetic Compatibility) must be considered before any medical electrical
equipment is installed or put into service. Follow the information in the accompanying
documentation when installing and operating the EM-4000.
Caution: Portable or mobile RF communication equipment can effect Medical Electrical
equipment.

Guidance and manufacturer's declaration electromagnetic emissions

Table 201

The EM-4000 is intended for use in the electromagnetic environment specified below.
The customer or the user of the EM-4000 should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions

Group 1

CISPR 11

The EM-4000 uses RF energy only for its internal

function. Therefore, its RF emissions are very
low and are not likely to cause any interference in
nearby electronic equipment.

RF emission

Class B

CISPR 11
Harmonic emissions

establishments, including domestic establishments

Class A

flicker emissions
IEC 61000-3-3

7-2

and those directly connected to the public low

voltage power supply network that supplies

IEC 61000-3-2
Voltage fluctuation/

The EM-4000 is suitable for use in all

Complies

buildings used for domestic purposes.

Guidance and manufacturer's declaration electromagnetic immunity

Table 202

The EM-4000 is intended for use in the electromagnetic environment specified below. The
customer or the user of the EM-4000 should assure that it is used in such an environment.
Immunity test
IEC 60601 test
Compliance level Electromagnetic environment levell
guidance
Electrostatic
6kV contact
6kV contact
Floors should be wood, concrete
Discharge(ESD)
8kV air
8kV air
or ceramic tile. If floors are
IEC 61000-4-2
covered with synthetic material,
the relative humidity should be
at least 30%.
Electrical fast
transient/ Burst
IEC 61000-4-4
Surge
IEC 61000-4-5

Voltage dips ,
short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11

Power frequency
(50/60 Hz)
magnetic fi eld
IEC 61000-4-8

2kV for power

supply lines
1kV for
input/output lines
1kV differential
mode
2kV common
mode
< 5 % UT
(> 95 % dip in
UT )
for 0,5 cycle
40 % UT
(60 % dip in UT )
for 5 cycles
70 % UT
(30 % dip in UT )
for 25 cycles
< 5 % UT
(> 95 % dip in
UT ) for 5 sec
3 A/m

2kV for power

supply lines
1kV for
input/output lines
1kV differential
mode
2kV common
mode
< 5 % UT
(> 95 % dip in
UT )
for 0,5 cycle
40 % UT
(60 % dip in UT )
for 5 cycles
70 % UT
(30 % dip in UT )
for 25 cycles
< 5 % UT
(> 95 % dip in
UT ) for 5 sec
3 A/m

Mains power quality should be

that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial
or hospital environment. If the
user of the EM-4000 requires
continued operation during
power mains interruptions,
it is recommended that the
EM-4000 is powered from an
uninterruptible power supply or
a battery.

Power frequency magnetic

fields should be at levels
characteristic of a typical
location in a typical commercial
or hospital environment.
NOTE : UT is the a.c. mains voltage prior to application of the test level.

7-3

Guidance and manufacturer's declaration electromagnetic

immunity

The EM-4000 is intended for use in the electromagnetic environment specified below.Table 204
The customer or the user of the EM-4000 should assure that it is used in such an environment.
Immunity test IEC 60601 test
Compliance Electromagnetic environment - guidance
level
level
Portable and mobile RF communication
equipment should be used no closer to
any part of the EM-4000, including cables,
than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter. Recommended separation
distance
Conducted RF 3 V rms
3 V rms
IEC 61000-4-6 150kHz to 80MHz

Radiated RF
IEC 61000-4-3

3 V/m
80MHz to 2,5GHz

3 V/m

d =1.2
d =1.2
d =2.3

80 MHz to 800 MHz

800 MHz to 2.5 GHz

Where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey, a should be less than the
compliance level in each frequency range.
B Interference may occur in the vicinity
of equipment marked with the following
symbol:

Note1 : At 80MHz and 800MHz, the higher frequency range applies.

Note2 : These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic
site survey should be considered. If the measured field strength in the location in which the
EM-4000 is used exceeds the applicable RF compliance level above, the EM-4000 should be
observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the EM-4000.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

7-4

Recommended separation distances between

portable and mobile RF communications equipment and the
Table 206
EM-4000
The EM-4000 is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the EM-4000 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the EM-4000 as recommended below,
according to the maximum output power of the communications equipment.

Rated maximum
output power of
transmitter
W

Separation distance according to frequency of transmitter

m
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz

d =1.2

d =1.2

d =2.3

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.
NOTE 1 : At 80MHz and 800MHz, the separation distance for the higher frequency range
applies.
NOTE 2 : These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and refl ection from structures, objects and people.

7-5

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7-6

Manufacturer
Tomey Corporation
2-11-33 Noritakeshinmachi
Nishi-ku, Nagoya 451-0051 JAPAN
Tel: +81 52-581-5327
Fax: +81 52-561-4735

EC-Representative
Tomey GmbH
Am Weichselgarten 19a
91058 Erlangen GERMANY
Tel: +49 9131-77710
Fax: +49 9131-777120

AUTHORIZED TOMEY SERVICE CENTERS

Headquarters, Pacific Rim
Tomey Corporation
2-11-33 Noritakeshinmachi
Nishi-ku, Nagoya 451-0051 JAPAN
Tel: +81 52-581-5327
Fax: +81 52-561-4735

Europe
Tomey GmbH
Am Weichselgarten 19a
91058 Erlangen GERMANY
Tel: +49 9131-77710
Fax: +49 9131-777120

Original instructions

20141014

0120