Topcon 3D OCT-1 User manual

USER MANUAL (for instrument body)
3D OPTICAL COHERENCE TOMOGRAPHY
3D OCT-1
Version 1.2x

1
INTRODUCTION
Thank you for purchasing the TOPCON 3D OCT-1 3D Optical Coherence Tomography.
INTENDED USE / INDICATIONS FOR USE
This instrument should be used to observe the eye and its adnexa and then photograph or record
them in order to present the electronic image information for diagnosis.
FEATURES
This instrument is a special photographic device used to observe, photograph and record the image
and tomogram of the fundus and anterior segment and present an electronic image for diagnosis.
By mounting the attachment for anterior segment photography, which is an optional accessory, you
can observe, photograph and record the tomogram of anterior segment.
(The attachment for anterior segment photography is an optional accessory.)
The built-in digital camera will take a picture of the fundus and anterior segment.
The instrument without the fundus/anterior segment photography function (hereinafter, "the instru-
ment without the fundus photography function") also exists.
After photographing, the images and tomograms of the fundus and anterior segment can be
recorded on the following device:
• The commercial personal computer connected to this instrument.
The observed/photographed images are displayed on the built-in control panel with touch panel.
The cable exclusively for connecting a personal computer (LAN cable) is provided.
Some types of this instrument have the automatic alignment function and the manual alignment
function.
PURPOSE OF THIS MANUAL
This manual outlines the 3D OCT-1 3D Optical Coherence Tomography, including operating proce-
dures, troubleshooting, maintenance and cleaning.
Before using the instrument, carefully read the "DISPLAY FOR SAFE USE" to familiarize yourself
with the features of the TOPCON 3D OCT-1 3D Optical Coherence Tomography and to ensure that
you operate it efficiently and safely.
Always keep this Instruction Manual at hand.
IPA font is used in some parts for 3D OCT-1. Any and all terms and conditions of "IPA Font License
Agreement v1.0" shall be deemed to be accepted and agreed by you if you use 3D OCT-1.
For IPA Font License v1.0, refer to the following URL.
http://ipafont.ipa.go.jp/ipa_font_license_v1.html
0123
CAUTION : Federal law restricts this device to the sale by or on the order of a physician.

2
1. No part of this manual may be copied or reprinted, in whole or in part, without prior written
permission.
2. The contents of this manual are subject to change without prior notice and without legal
obligation.
3. The contents of this manual are correct to the best of our knowledge. Please inform us of
any ambiguous or erroneous descriptions, missing information, etc.
4. Original Instructions
This instruction manual was originally written in English.
©2012 TOPCON CORPORATION
ALL RIGHTS RESERVED

3
CONTENTS
INTRODUCTION ......................................................................................................................... 1
GENERAL SAFETY INFORMATION .................................................................................... 5
HOW TO USE THIS MANUAL ................................................................................................ 7
GENERAL MAINTENANCE INFORMATION ...................................................................... 7
DISCLAIMERS ............................................................................................................................ 7
DISPLAYS AND SYMBOLS FOR SAFE USE .................................................................... 8
POSITIONS OF WARNING AND CAUTION INDICATIONS .......................................... 9
SYSTEM DIAGRAM .......................................................................................................................... 10
COMPONENT NAMES .................................................................................................................. 10
COMPOSITION OF PARTS THAT COME IN CONTACT WITH THE PATIENT ........................... 10
OPERATION METHOD OF CONTROL PANEL ............................................................................ 11
NAMES ON THE CONTROL PANEL ............................................................................................. 11
STANDARD ACCESSORIES ......................................................................................................... 40
PREPARATIONS ............................................................................................................................... 41
INSTALLATION .............................................................................................................................. 41
CONNECTING THE POWER CORD ............................................................................................. 42
CONNECTING THE EXTERNAL I/O TERMINALS ........................................................................ 43
RECOVERY FROM POWER SAVE STATUS ............................................................................... 44
ADJUSTING THE CONTROL PANEL POSITION ......................................................................... 44
BASIC OPERATIONS ....................................................................................................................... 45
FLOW OF OPERATION ................................................................................................................. 45
PREPARATION FOR PHOTOGRAPHY ........................................................................................ 46
Selecting the Patient and Setting the Photography ........................................................................ 47
FUNDUS TOMOGRAPHY ............................................................................................................. 52
Check for photographic data and report output .............................................................................. 58
HOW TO SHUT DOWN ................................................................................................................. 59
OBJECTIVE OPERATIONS ............................................................................................................ 60
COLOR FUNDUS PHOTOGRAPHY .............................................................................................. 60
COLOR ANTERIOR SEGMENT PHOTOGRAPHY ....................................................................... 64
FUNDUS PERIPHERAL PHOTOGRAPHY .................................................................................... 66
DELETING DATA ........................................................................................................................... 74
SAVING DATA ............................................................................................................................... 75
PRINTING DATA ............................................................................................................................ 75
DETAILS OF THE SETTING MENU ............................................................................................. 76
BEFORE REQUESTING SERVICE .............................................................................................. 91
TROUBLESHOOTING ................................................................................................................... 91
SPECIFICATIONS AND PERFORMANCE ................................................................................. 95
SYSTEM DIAGRAM ....................................................................................................................... 95
SPECIFICATIONS BY ITEMS ........................................................................................................96
OTHER SPECIFICATIONS ............................................................................................................ 97
ELECTROMAGNETIC COMPATIBILITY ....................................................................................... 98
Requirements for the EXTERNAL DEVICE ................................................................................. 101
PATIENT’S ENVIRONMENT ....................................................................................................... 102
SPECIFICATIONS OF THE PERSONAL COMPUTER (COMMERCIAL
PRODUCT) TO BE CONNECTED ............................................................................................... 103

4
SPECIFICATIONS OF THE INSULATION TRANSFORMER (COMMERCIAL
PRODUCT) TO BE CONNECTED ............................................................................................... 103
GENERAL INFORMATION ON USAGE AND MAINTENANCE ......................................... 104
INTENDED PATIENT POPULATION ........................................................................................... 104
INTENDED USER PROFILE ........................................................................................................ 104
ENVIRONMENTAL CONDITIONS FOR USE .............................................................................. 104
STORAGE, USAGE PERIOD ...................................................................................................... 104
ENVIRONMENTAL CONDITIONS FOR PACKAGING IN STORAGE ......................................... 105
ENVIRONMENTAL CONDITIONS FOR PACKAGING IN TRANSPORTAION ........................... 105
ELECTRIC RATING ..................................................................................................................... 105
DIMENSIONS AND WEIGHT ....................................................................................................... 105
SYSTEM CLASSIFICATION ........................................................................................................ 106
OPERATION PRINCIPLE ............................................................................................................ 107
CHECKPOINTS FOR MAINTENANCE ........................................................................................ 108
DISPOSAL ................................................................................................................................... 108
MAINTENANCE ............................................................................................................................... 109
DAILY CHECKUPS ...................................................................................................................... 109
ORDERING CONSUMABLES ..................................................................................................... 109
REPLACING THE XENON LAMP ................................................................................................ 110
REFILLING THE CHIN-REST PAPER SHEET ............................................................................ 111
MAINTENANCE BY THE DEALER .............................................................................................. 111
CLEANING ................................................................................................................................... 112
OPTIONAL ACCESSORIES ......................................................................................................... 114
ATTACHMENT FOR ANTERIOR SEGMENT HA-2 ..................................................................... 114
REFERENCE MATERIAL .............................................................................................................. 115
SCAN PATTERN SPECIFICATIONS ........................................................................................... 115
TYPE OF PLUG ........................................................................................................................... 117
RELATION BETWEEN THE SETTING OF THE ILLUMINATION/FLASH LEVEL AND
MAXIMUM RADIANCE ................................................................................................................... 118
3D OCT-1 SOFTWARE LICENSE TERMS .............................................................................. 119

5
GENERAL SAFETY INFORMATION
CONTRAINDICATIONS
This instrument must not be used for the following patients:
• Patients who are hypersensitive to light
• Patients who recently underwent photodynamic therapy (PDT)
• Patients taking medication that causes photosensitivity.
WARNINGS
Ensuring the Safety of Patients and Operators
Use this instrument carefully on the following patients.
• Patients who have epidemic corneitis, conjunctivitis or any other infectious disease
• Patients who are taking medications that cause light hypersensitivity.
This instrument is a photography device to observe, photograph/record the eyeballs and their adnexa
and give the electronic image information for diagnosis. Doctors must be responsible for diagnoses.
Be careful not to hit the patient's eyes or nose with the instrument during operation.
The patient may be injured.
Handling the cord on this product or cords associated with accessories sold with this product, will expose
you to lead, a chemical known to the State of California to cause birth detects or other reproductive harm.
Wash hands after handling.
Preventing Electric Shock and Fire.
To avoid fire and electric shock, install the instrument in a place free of water and other liquids.
To avoid fire and electric shock, do not put cups or vessels containing liquids near the instrument.
To avoid electric shock, do not insert metal objects into any vents and/or slots.
To avoid fire in the event of an instrument malfunction, immediately turn OFF ( ) the Power switch and
unplug the cable if you see smoke coming from the instrument or if you detect other problems.
Don't install the instrument where it is difficult to unplug the cable from the instrument body.
Ask your dealer for repairs.

6
CAUTIONS
Ensuring the Safety of Patients and Operators
When operating the chin-rest up/down button, be careful not to pinch the patient's hand to avoid possi-
ble injury.
To avoid injury of the patient, be careful not to bump the patient's eye or nose with the instrument and
external fixation target when operating the control panel.
Preventing Electric Shock and Burn
To avoid electric shock, do not open the instrument.
Request service from an authorized Topcon distributor.
Do not put any substance over the vent on the top surface of the main unit. If the vent is covered, the
temperature of the power supply unit may rise abnormally and cause a malfunction. To prevent the
instrument from malfunctioning, do not drop any liquid into the vent.
Electromagnetic Compatibility (EMC)
This instrument has been tested (with 100V/120V/230V) and found to comply with IEC60601-1-2:
2007.
This instrument radiates radio frequency energy within standard and may affect other devices in the
vicinity.
If you have discovered that turning on/off the instrument affects other devices, we recommend you
change its position, keep a proper distance from other devices, or plug it into a different outlet.
Please consult the dealer from whom you purchased the instrument if you have any additional ques-
tions.

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HOW TO USE THIS MANUAL
• Read the instructions on pages 1 to 9 before using the machine.
• Regarding connection to various devices, see "CONNECTING THE EXTERNAL I/O TERMI-
NALS"on page 43.
• If you would like an overview of the system, begin by reading "BASIC OPERATIONS" (page 45).
GENERAL MAINTENANCE INFORMATION
USER MAINTENANCE
To ensure the safety and performance of the instrument, all maintenance work should be conducted by
trained service engineers.
The following maintenance task may be done by the user.
For details, see the relevant part of this manual.
Cleaning the objective lens:
The objective lens may be cleaned by the user. For details, see "Cleaning the objective lens" on page
113.
DISCLAIMERS
TOPCON shall not take any responsibility for damage due to fire, earthquakes, actions by third
persons and other accidents, or damage due to negligence and misuse by the user and any
use under unusual conditions.
TOPCON shall not take any responsibility for damage derived from inability to properly use this
instrument, such as loss of business profit and suspension of business.
TOPCON shall not take any responsibility for damage caused from using this instrument in a
manner other than that described in this Instruction Manual.
Diagnoses made shall be the responsibility of pertaining doctors and TOPCON shall not take
any responsibility for the results of such diagnoses.

8
DISPLAYS AND SYMBOLS FOR SAFE USE
To encourage safe and proper use and to prevent injury to the operator and others or potential damage to
property, important messages are put on the instrument body and inserted in the instruction manual.
We suggest that everyone understand the meaning of the following displays, icons and text before read-
ing the "GENERAL SAFETY INFORMATION" and observe all listed instructions.
DISPLAYS
SYMBOL
Display Meaning
CONTRAINDICATIONS
Situations in which the device should not be used because the
risk of use clearly outweighs any possible benefit.
WARNINGS Incorrect handling by ignoring this display may lead to a risk of
death or serious injury.
CAUTIONS Incorrect handling by ignoring this display may lead to
personal injury or physical damage.
NOTES Useful functions to know. Paying attention to these will
prevent the noted problems.
Symbol IEC/ISO Publication Description Description (French)
IEC 60417-5032 Alternating Current Courant alternatif
IEC 60417-5008 Off (power: disconnection from
the main power supply)
Éteint (courant: coupure avec le
secteur)
IEC 60417-5007 On (power: connection to the
main power supply)
Allumé (courant: raccordement
sur le secteur)
IEC 60878-02-02 Type B applied part Partie appliquée du Type B
ISO 7010-W001 General warning sign Symbole d'avertissement
général
ISO 7010-M002 Refer to instruction manual/
booklet Voir le manuel/la brochure
ISO 7000-2497 Date of manufacture Date de fabrication
ISO 7000-2498 Serial number Numéro de série
IEC60417-5021 Equipotentiality Equipotentialité

9
POSITIONS OF WARNING AND CAUTION INDICATIONS
To ensure safety, this machine provides warning displays. Use the instrument correctly by observing
the display instructions. If any of the following display labels are missing, contact your TOPCON dealer
at the address listed on the back cover.
No. Label Meaning Signification
1
WARNING
To avoid injury caused by electric
shock, do not open the cover.
Ask your dealer for service.
MISE EN GARDE
Ne pas ouvrir le couvercle pour
éviter les blessures causées par
un choc électrique.
Demander au revendeur d'effec-
tuer le service.
2
CAUTION
When operating the chinrest up/
down switch, be careful not to
pinch the patient's hand.
The patient may be injured.
PRÉCAUTION
Prendre garde de ne pas pincer
la main du patient en opérant le
commutateur haut/bas du sup-
port de jugulaire.
Le patient pourrait être blessé.
3
CAUTION
Be careful not to hit the patient's
eyes or nose with the instrument
during operation.
PRÉCAUTION
Prendre garde de ne pas frapper
les yeux ou le nez du patient
avec l'instrument pendant
l'opération.
4
CAUTION-CLASS 3B INVISI-
BLE LED RADIATION WHEN
OPEN AVOID EXPOSURE TO
THE BEAM.
ATTENTION -
RAYONNEMENT LED INVISI-
BLE DE CLASSE 3B - EN CAS
D’OUVERTURE EXPOSITION
AU FAISCEAU DANGEREUSE
5
Degree of protection against
electric shock
: TYPE B APPLIED PART
Degré de protection contre les
chocs électriques
: TYPE B PARTIE D'APPLICA-
TION
1
3
2
4
5

10
SYSTEM DIAGRAM
SYSTEM DIAGRAM
COMPONENT NAMES
COMPOSITION OF PARTS THAT COME IN CONTACT WITH THE PATIENT
Forehead rest : Silicone rubber
Chin-rest : Acrylonitrile butadiene styrene resin
Chin-rest paper pin : Polyamide resin
Power supply unit
Chin-rest unit
External fixation target
External I/O terminal cover
Control panel
Forehead rest *1
Canthus marker
Chin-rest paper pin
Chin-rest *1
Objective lens
Power switch
Main unit
Anterior segment stereoscopic
camera *2
*1: Contacting part (class B)
*2: This unit is placed at the right and left sides of objective lens.
*3: There are eight targets around the objective lens.
Peripheral fixation target *3

11
SYSTEM DIAGRAM
OPERATION METHOD OF CONTROL PANEL
NAMES ON THE CONTROL PANEL
Display areas and functions on the control panel
The control panel is designed as a touch panel. Information is displayed on the control panel and you
can perform a variety of operations by touching the screen.
NOTES
Operate the control panel with your fingers or the attached touch
pen. Do not use any sharp tools;
e.g. ball point pen.
The touch panel may be damaged to cause an incorrect opera-
tion.
1234ABCD
Tap To select any relevant item. Continue to press Used for continuous moving.
(Moving of chin-rest and main unit)
Touch the screen softly with a finger. Continue to touch the screen softly with a finger.

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SYSTEM DIAGRAM
Capture icon selection screen
You can select the optimal mode for various types of photography.
[MENU] button : Shifts to the capture icon selection screen. This does not operate on
the capture icon selection screen.
Patient ID display area : Displays the patient ID.
[SET UP] button : Shifts to the setting menu screen.
Status display area : Displays the message.
Capture icon display area : By selecting a tab, the capture icons registered in each tab are dis-
played.
When color fundus photography is set to OFF or when the instrument
without the fundus photography function is used, the fundus image
among the capture icons is displayed in monochrome.
Capture eye selection button : Select an eye to be captured.
Capture icon display
area
Patient ID display area
[SET UP] button
Status display area
Capture eye selection
button
[MENU] button

13
SYSTEM DIAGRAM
Photography screen (Chin-rest adjustment)
As watching the anterior segment observation image and the image of the anterior segment stereo-
scopic camera, adjust the chin-rest.
[MENU] button : Shifts to the capture icon selection screen.
Patient ID display area : Displays the patient ID.
Capture information display
area
: Displays the captured eye and picture angle.
Operation guide : Displays how to operate this screen.
Movie area 1 : Displays the anterior segment observation image. Touch the pupil to be
within the frame.
Movie area 2 : Displays the image of the anterior segment stereoscopic camera, which
is nearer to the captured eye than the other. Align the eye height to the
canthus marker of the chin-rest unit with the lines on the screen as stan-
dard.
Chin-rest up/down button : Moves the chin-rest up and down.
Press the upper part of the button, and the chin-rest moves up. Press
the lower part of the button, and the chin-rest moves down.
Capture eye selection
button
: Select an eye to be captured.
1234ABCD
Capture start
button
Capture eye
selection button
Movie area 1
Chin-rest
up/down
button
Movie area 2
[MENU] button
Operation guide
Patient ID display area Capture information display area
External fixation target selector button Advance button

14
SYSTEM DIAGRAM
External fixation target
selector button
: Tap this button, and the external fixation target is selected. Displays the
status (ON/OFF) of the external fixation target. You can change ON/
OFF of the external fixation target with this button.
Advance button : Tap this button, and the "Advance" mode is accessed. In the "Advance"
mode, the following operations can be performed: selecting the small
pupil diaphragm, turning ON/OFF the color fundus photography(*),
changing the diopter compensation lens, and selecting the "Cataract"
mode.
(*) When the instrument without the fundus photography function is
used and when the color fundus photography function is OFF, the
color fundus photography ON/OFF button is not displayed.
Capture start button : Starts photographing.
Displays the status of the internal fixation target.
(Background is gray.)
Displays the status of the external fixation target.
(Background is orange.)

15
SYSTEM DIAGRAM
Photography screen (Chin-rest adjustment): Advance mode
When you set "ON" for the "Advance" mode on the screen where you adjust the chin-rest as watching
the anterior segment observation image and the image of the anterior segment stereoscopic camera,
this screen appears.
Small pupil diaphragm
selector button
: Displays the small pupil diaphragm status (ON/OFF). You can change
the ON/OFF status of the small pupil diaphragm. When the pupil diame-
ter of the patient is small (pupil diameter is approx. 4.0mm or less), set
it to ON and take a picture.
When the color fundus photography is done (excluding the color fundus
photography when taking the fundus tomogram), the automatic small
pupil (diaphragm) function can be set. While this function is set, the
small pupil diaphragm is automatically set to ON and the instrument
takes a color picture of fundus if the pupil diameter is small (pupil diame-
ter is approx. 4.0mm or less). After taking a picture, it is set to OFF.
When you set this function, in the color fundus photography mode, it is
not necessary to set the small pupil diaphragm to ON with this button
even if the pupil diameter is small.
Color fundus photography
ON/OFF button
: You can turn ON/OFF the color fundus photography. When the instru-
ment without the fundus photography function is used and when the
color fundus photography function is OFF, this button is not displayed.
1234ABCD
Diopter compensation
lens selector button
[MENU] button
Small pupil diaphragm selector button
Cataract mode button
Color fundus photography ON/OFF button

16
SYSTEM DIAGRAM
Diopter compensation
lens selector button
: Tap [+LENS] to increase the power. Tap [-LENS] to decrease the power.
The center button displays "No compensation lens".
NOTES
• When the patient's eye has a strong myopia, set the diopter compensation
lens selector button to (-).
When the patient's eye has a strong hyperopia, set the diopter compensation
lens selector button to (+).
Compensation range: 0 : -13 – +12D
- : -12 – -33D
+ : +11 – +40D
• When the diopter compensation lens is set to a value other than "0", the split
lines disappear. At the same time, the functions of auto focus, auto shoot and
auto small pupil (diaphragm) are invalidated. The OCT auto focus function is
validated.
Cataract mode button : You can select the execution of automatic optimizing in the "Cataract"
mode. Set "ON" for the "Cataract" mode and tap the [Capture START]
button. Automatic optimizing is performed in the "Cataract" mode. The
"Cataract" mode is kept until the patient is changed to another. When
the patient is changed to the next, default is set again.
(The "Cataract" mode performs optimizing by moving the base up and
down or right and left when a clear tomogram cannot be obtained.)

17
SYSTEM DIAGRAM
Photography screen (Automatic alignment to pupil)
This screen is used to perform automatic alignment to pupil. Alignment is performed by the image of
the right and left anterior segment stereoscopic cameras.
CAUTIONS To avoid injury of the patient, be careful not to hit the patient with the
instrument during automatic alignment.
Movie area : Displays the image of the right/left anterior segment stereoscopic camera.
Manual mode button : Tap the [Manual mode] button. The system stops automatic adjustment of
the captured eye and shifts to the "Manual adjustment mode" screen where
you can adjust the captured eye manually.
Processing message : Displays the current processing status.
NOTES
When opening the eyelid (opening the eyelid by hand), be careful not to touch
the anterior segment stereoscopic camera by hand. If your hand touches it,
automatic alignment is not performed normally from time to time.
1234ABCD
Movie area
Manual mode button
Processing message

18
SYSTEM DIAGRAM
Photography screen (Manual alignment to pupil)
This screen is used to perform manual alignment to pupil. Tap the pupil displayed on Camera 1 and
Camera 2.
Operation guide : Displays how to operate this screen.
Movie area 1 : Displays the image of the anterior segment stereoscopic camera 1.
Movie area 2 : Displays the image of the anterior segment stereoscopic camera 2.
Processing message : Displays the current processing status.
[BACK] button : Returns to the photography screen (chin-rest adjustment).
Capture start button : Starts photographing. Tap the screen of Camera 1/Camera 2, and it is
active.
1234ABCD
Capture start
button
[BACK] button
Movie area 2
Operation guide
Processing message
Movie area 1