Huvitz HOCT-1 User manual

OPTICAL COHERENCE TOMOGRAPHY
HOCT-1/1F
USER MANUAL

2
IMPORTANT NOTICE
This product may malfunction due to electromagnetic waves caused by portable personal telephones, transceivers,
radio-controlled toys, etc. Be sure to avoid having objects such as, which affect this product, brought near the
product.
The information in this publication has been carefully checked and is believed to be entirely accurate at the time of
publication. HUVITZ assumes no responsibility, however, for possible errors or omissions, or for any
consequences resulting from the use of the information contained herein.
HUVITZ reserves the right to make changes in its products or product specifications at any time and without prior
notice, and is not required to update this documentation to reflect such changes.
■Revision History
Revision
Date
Approval
Description
A
2017.11.21
First issued
B
2018.10.16
3.2 Intended Use - “and so on” was deleted.
6.3, 6.6.4, 6.6.5 - addition
C
2018.02.27
Various function is added and modified.
(ex. Fundus enhancement, segmentation edit and
so on)
D
2019.03.05
Angio Function Added.
9000ENG0040-D
(2019.01.31)
©2018 HUVITZ Co., Ltd.
38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, 14055, Republic of Korea
All rights reserved.
Under copyright laws, this manual may not be copied, in whole or in part, without the prior written consent of
HUVITZ Co., Ltd.

HOCT-1/1F
CONTENTS
SAFETY PRECAUTIONS.............................................................................................................................................5
1.1. Overview ............................................................................................................................................................................................5
Symbol Information....................................................................................................................................................6
2.1. Usage Precautions.............................................................................................................................................................................9
2.2. Environmental Considerations ........................................................................................................................................................12
2.3. Safety Precautions...........................................................................................................................................................................14
INTRODUCTION........................................................................................................................................................17
3.1. System Outline.................................................................................................................................................................................17
3.2. Intended Use....................................................................................................................................................................................17
3.3. Classification ....................................................................................................................................................................................17
3.4. Contraindications .............................................................................................................................................................................17
3.5. Patient requirements........................................................................................................................................................................17
3.6. Operating Principles.........................................................................................................................................................................18
3.6.1. Fundus image.........................................................................................................................................................................................................................18
3.6.2. The anterior segment/fundus tomogram................................................................................................................................................................18
3.6.3. The angiography of a retina (Optional) ...................................................................................................................................................................18
3.7. Applied Standard List.......................................................................................................................................................................18
System Overview......................................................................................................................................................19
4.1. Configuration and Functions............................................................................................................................................................19
4.2. Main Body Screen Description ........................................................................................................................................................22
4.2.1. OCT/Fundus mode (HOCT-1F only) ...........................................................................................................................................................................22
4.2.2. OCT mode................................................................................................................................................................................................................................24
4.2.3. Fundus mode (HOCT-1F only) ......................................................................................................................................................................................24
4.2.4 Angiography mode (Optional) .......................................................................................................................................................................................26
Installation Procedure ..............................................................................................................................................28
5.1. System installation ...........................................................................................................................................................................28
Operation..................................................................................................................................................................31
6.1. Software ...........................................................................................................................................................................................31
6.2. SETUP Mode ...................................................................................................................................................................................33
6.3. DICOM SETUP Mode ......................................................................................................................................................................38
6.4. General Operation ...........................................................................................................................................................................40
6.5. Anterior segment image operation (optional)..................................................................................................................................53
6.5.1. Preparation for anterior segment operation .........................................................................................................................................................53
6.5.2. Capturing anterior segment ...........................................................................................................................................................................................53
6.6. Analyze.............................................................................................................................................................................................60
6.6.1. Entering Analysis screen...................................................................................................................................................................................................60
6.6.2. OCT Macular 3D Analysis screen.................................................................................................................................................................................61
6.6.3. OCT Disc 3D Analysis screen .........................................................................................................................................................................................73
6.6.4. OCT Macular Wide Analysis screen ............................................................................................................................................................................85
6.6.5. OCT Anterior Radial Analysis screen..........................................................................................................................................................................99
6.6.6. OCT Anterior Line Analysis screen........................................................................................................................................................................... 110
6.6.7. Fundus Analysis screen .................................................................................................................................................................................................. 119
6.6.8 Angiography Analysis screen ...................................................................................................................................................................................... 128
6.7. Maintenance...................................................................................................................................................................................137
6.7.1. After operation ................................................................................................................................................................................................................... 137
6.7.2. Cleaning ................................................................................................................................................................................................................................. 139
6.7.3. Replacement of consumables and fuse ................................................................................................................................................................ 141
6.7.4. Calibration............................................................................................................................................................................................................................. 141
6.7.5. Self-diagnosis using Model eye................................................................................................................................................................................. 142
Troubleshooting Guide...........................................................................................................................................146
Specifications and Accessories .............................................................................................................................147
8.1. Standard Accessories ....................................................................................................................................................................147

4
8.2. Specifications .................................................................................................................................................................................148
8.3. Drawings of System .......................................................................................................................................................................149
EMC INFORMATION................................................................................................................................................150
SERVICE INFORMATION ........................................................................................................................................152
SOFTWARE LICENSE AGREEMENTS ....................................................................................................................153

HOCT-1/1F
SAFETY PRECAUTIONS
1.1. Overview
Safety is everyone’s responsibility. The safe use of this instrument is largely dependent upon the installers, users,
operators, and managers. It is prerequisite to read and understand these specifications before installing, using,
cleaning, fixing or revising. Fully understanding the whole instructions must be the first priority. For this reason, the
following safety notices have been placed appropriately within the text of this manual to highlight safety related
information or information requiring special emphasis. All users, operators, and maintainers must be familiar with and
pay particular attention to all signs of Warnings and Cautions.
“Warning” indicates the presence of a hazard that could result in severe personal injury, death or substantial
property damage if ignored.
“Caution” indicates the presence of a hazard that could result in minor injury, or property damaged if ignored.
This is used to emphasize essential information.
Be sure to read this information to avoid operating the device incorrectly.
1
!
WARNING
!
CAUTION
!
NOTE

6
Symbol Information
The International Electrotechnical Commission (IEC) has established a set of symbols for medical electronic
equipment which classify a connection or warn of any potential hazards. The classifications and symbols are shown
below.
Symbol
Indication
This symbol identifies a safety note. Ensure you understand the function of this control before
using it. Control function is described in the appropriate User’s or Service Manual.
(Ce symbole identifie une note de s curit . Assurez-vous de comprendre la fonction de ce
contr le avant de l'utiliser. La fonction de contr le est d crite dans le manuel d'utilisation ou
d'entretien appropri .)
I and O on power switch represent ON and OFF respectively.
(O sur l'interrupteur d'alimentation repr sentent
respectivement ON et OFF.)
Temperature Limitation
(Limitation de temp rature)
Atmospheric pressure limitation
(Limitation de pression atmosph rique)
Humidity limitation
(Limite d'humidit )
Stack direction
(Direction de la pile)
Keep DRY
(Garder au sec)
Fragile , handle with care
(Fragile, manipuler avec soin)
Keep away from sunlight
(Tenir  l' cart de la lumi re du soleil)
Stack layer limit
(Limiter la couche de pile)
CE Mark
(Marque CE)
Use no hook
(N'utilisez aucun crochet)
2

HOCT-1/1F
WEEE Symbol – EU only
Disposal of your old appliance
When this crossed-out wheeled bin symbol is attached to
a product it means the product is covered by the European
Directive 2002/96/EC.
All electrical and electronic products should be disposed of
separately from the municipal waste stream via designated
collection facilities appointed by the government or the local
authorities.
The correct disposal of your old appliance will help prevent
potential negative consequences for the environment and
human health. For more detailed information about disposal of
your old appliance, please contact your city office, waste
disposal service or the shop where you purchased the product.
(Symbole WEEE- EU seulement
Mise au rebut de votre ancien appareil
Lorsque ce symbole de poubelle barr e est joint  un produit,
cela signifie que le produit est couvert par la directive
europ enne 2002/96 / CE.
Tous les produits  lectriques et  lectroniques doivent  tre
 limin s s par ment du flux des d chets municipaux via des
installations de collecte d sign es par le gouvernement oules
autorit s locales. L' limination correcte de votre ancient
appareil aidera  pr venir les cons quences negatives
potentielles sur l'environnement et la sant humaine.
Pour plus d'informations sur l' limination de votre ancient
appareil, veuillez contacter votre mairie, le service
d' limination des d chets ou le magasin o vous avez achet
le produit.)
Authorized representative in the European Community – EU
ONLY
(Repr sentant autoris dans la Communaut europ enne-
EU seulement)
Manufacturer
(Fabricant)
Date of manufacture
(Il indique l'ann e de fabrication et le fabricant.)
Refer to instruction manual/booklet
(Se reporter au manuel d’instructions / brochure)
Type B Isolated patient connection
(Type B Connexion patient isol e.)
Warning: Crushing or insert of hand
(Attention:  crasement ou insertion de la main)
QR code
(QR code)

8
Alternating Current
(Courant alternative)
Consult instructions for use
(Consulter les instructions d'utilisation)
The United States and Canada have mutual-recognition agreements.
Therefore, if certified using a Canadian specification (CSA) for UL, the
certification mark for the product will be a C-UL certification mark which
means CSA specification compliance as follows.
(Les États-Unis et le Canada ont conclu des accords de libre-échange. Par
conséquent, si l'on obtient une certification au moyen d'une spécification
canadienne (CSA) pour l'AMT, la marque de certification pour le produit sera
une marque de certification C-UL, ce qui signifie la conformité de la
spécification CSA comme suit.)
Class I Laser Product
(Produit au laser de classe I)
CE for RoHS
RoHS Directive Compliance 2011/65/EU
(CE pour les RoHS Respect de la directive en matière de conformité
2011 / 65 / CE)

HOCT-1/1F
2.1. Usage Precautions
This equipment has been developed and tested in conformity with domestic & international safety standards and
regulations, which guarantees the high stability of this product. This guarantees a very high degree of safety for this
device. The legislator expects us to inform the user expressively about the safety aspects in dealing with the device.
The correct handling of this equipment is imperative for its safe operation. Therefore, please read carefully all
instructions before switching on this device. For more detailed information, please contact our Customer Service
Department or one of our authorized representatives.
For use of equipment in rated voltage less than 125Vac, minimum 6A, Type SJT or SVT, 18/3AWG, 10A, max
3.0m long: One end with Hospital Grade Type, NEMA 5-15P Other end with appliance coupler. For use of
equipment in rated voltage less than 250Vac, minimum 6A, Type SJT or SVT, 18/3AWG, 10A, max 3.0m long:
One end terminated with blade attachment plug(HAR) Type, NEMA 6-15P.
Use instrument that comply with IEC60601-1 in the patient environment. [The figure below show]
If and instrument that does not comply with IEC 60601-1 is to be used, use an isolation transformer.
If a person handling a conductive part of the system comes into contact with a patient at the same time, hazard
may occur due to leakage current exceeding the value specified in the applicable standard. Be careful not to touch
patients when connecting or removing the power plug or cable connectors.
!
CAUTION
!
CAUTION

10
During the Anterior segment image operation, pull the joystick toward the operator before adjusting the alignment.
Move the body to align patient’s eye. Move the body slowly while watching patient’s eye and body, because working
distance is just 15mm that the front lens is very close to patient's eye.
This instrument includes lithium battery. This hazardous material needs to be disposed of properly to limit
environmental pollution. Please contact to the professional waste disposal company.
Do not install any software on OCT built-in computer without our consent.
The manufacturer is not responsible for any failure due to random installation.
!
CAUTION
!
CAUTION
!
CAUTION

HOCT-1/1F
The equipment is a Class I LED Product. The LED used for the equipment is safe under expected use conditions
including situation such as looking into the LED using optical equipment.
However, observe the following precautions when using the equipment
Do not direct LED beams to human eyes when unnecessary.
Do not look into the objective lens for a prolonged time.
Class 3R invisible LED radiation when Optical system subassembly open.
Avoid exposure to the beam.
The longer the duration of exposure and the greater the number of pulses, the greater the risk of
ocular damage. Exposure to light from this instrument when operated at maximum output will exceed
the safety guideline after 9.9 x 107 sec for Retina IR, 5.3 x 107 sec for Working dot(Manual Focusing),
4.1 x 107 sec for Kerato ring(Auto / Manual Tracking), 9.5 x 107 sec for Kerato focus(Auto/Manual
Tracking), 1.0 x 108 sec for Split focus(Optimizing), 9.1 x 105 sec for external fixation lamp, 4.8 x 107
sec for SLD Laser(OCT scanning), 1,936,114 pulses for the light source of fundus image capture.
Note 1: The exposure time and number of pulses from all light sources is cumulative and additive.
Note 2: If the intensity of any of the light sources is reduced to 50% of the maximum intensity, the
exposure time or number of pulses for that light source to reach the exposure guideline is doubled.
This linear relationship can be used to determine the time to reach the exposure guideline for the
combination of light sources at various intensity settings.
Note 3: The weighted retinal radiant exposure guideline is 10 J/cm2
<Spectrum output of all light source during measurement (maximum light intensity)>
<Relationship between fundus flash level and maximum light intensity>
!
CAUTION

12
2.2. Environmental Considerations
Avoid the following environments for operation or storage:
Where the instrument is exposed to water vapor.
Don’t operate the instrument with wet hands Indoor use only.
Where the instrument is exposed to direct sunlight.
A place where the equipment can be exposed to direct ultraviolet.
Where there are big changes in temperature.
Optimal temperature range for normal operation is from 10C to 35C (Humidity : 30 ~
90%).
Where there is hot equipment nearby.
Where the humidity is extremely high or there is a ventilation problem.
Where the instrument is exposed to excessive shocks or vibrations.
Where the instrument is exposed to chemical material or explosive gas.
Be cautious so that things like dust and metal do not fall inside the instrument.
Don’t disassemble or open the product. HUVITZ does not take responsibility for the
possible problems
Be careful not to block the fan of the instrument.

HOCT-1/1F
Don’t plug the AC power cable into the outlet unless all parts of the instrument are
completely connected. Otherwise, it will cause severe damage on the instrument.
Pull out the power cable with holding the plug, not the cord.
To avoid risk of electric shock, this equipment must only be connected to a supply mains
with protective earth.
For the normal operation of the instrument, please keep the ambient temperature is 10℃ ~ 35℃, humidity is 30% ~
90% and atmospheric pressure is 800 ~ 1060hpa. For the Transportation of the instrument, please keep the ambient
temperature is -40℃ ~ 70℃, humidity is 10% ~ 95% and atmospheric pressure is 500 ~ 1060hpa. For the Storage of
the instrument, please keep the ambient temperature is -10℃ ~ 55℃, humidity is 10% ~ 95% and atmospheric
pressure is 700 ~ 1060hpa. Avoid environments where the equipment is exposed to excessive shocks or vibrations.

14
2.3. Safety Precautions
1. This is an electric medical device. Useis limited to doctors or persons qualified by the law of each country.
2. Do not make a diagnosis base on a single captured image. Doctors are responsible for making the final
diagnosis based on the present and past medical records of the patient such as captured images. Without
sufficient information, proper diagnosis may not be made.
3. When instrument is send back to A/S center for repair or maintenance, or before authorized service man is
arrived at the place for repair or maintenance, wipe the surfaces of the instrument (especially, the areas that
come into contact with the patient) with a clean cloth dampened with rubbing alcohol.
4. If a user uses power save supported by Windows 10 except for the power save in User setting, it causes some
trouble in HOCT. The manufacturer isn't responsible for the problem.
5. User must not change the setting supported by the manufacturer, This change might make some trouble in
HOCT. The manufacturer isn't responsible for the problem.
6. This equipment must not be used in an area that is in danger of explosions and in the presence of flammable,
explosive, or volatile solvent such as alcohol, benzene or similar chemicals.
7. Do not place or store this instrument in humid area. Do not expose the device to water splashes, dripping
water, or sprayed water. Do not place containers with fluids, liquids, or gases on top of this instrument.
8. The instrument must be operated by a trained and qualified person or under his or her supervision.
9. Repair of this instrument must be conducted by HUVITZ’s service technicians or other authorized persons.
10. Maintenance by users must observe the User’s Manual and Service Manual. Any additional maintenance may
only be performed by HUVITZ’s service technicians or other authorized persons.
11. Manufacturers are responsible for the safety, reliability, and performance of this instrument only when the
following requirements are fulfilled.
(1) When the instrument has been installed in a proper area, following the manual.
(2) When the instrument has been operated and maintained according to the manual and service manual.
12. Manufacturers are not responsible for the damages caused by unauthorized alterations. Such tampering will
forfeit any rights to receive services during the term of guarantee.
13. This instrument must be connected with the accessories supplied by HUVITZ. If you are to use other
accessories, their safety or usability must be checked and proved by their manufacturers or HUVITZ.
14. Only those who have undergone proper training and instructions are authorized to install, use, operate, and
maintain this instrument.
15. Keep the User’s Manual and Service Manual in a place easily accessible at all times for persons operating and
maintaining the equipment.

HOCT-1/1F
16. Do not apply excessive force to cable connections. If the cable does not connect easily, make sure that the
connector (plug) is appropriate for the receptacle (socket). If you caused any damage to a cable connector(s)
or receptacle(s), let the damage(s) be repaired by an authorized service technician.
17. Please do not pull on any cable. Always grab the plug when disconnecting cables.
18. Before you use, check the exterior of the instrument and its conditions.
19. Do not block any ventilation outlet necessary for proper heat dissipation.
20. If smoke, sparks or any abnormal noise or smell is noticed coming from the instrument, please switch the
power off immediately and pull out the plug.
21. When you carry this product, please use a hand cart. If you want to move the product to other area, please
contact customer service center.
22. To avoid the risk of electric shock, this instrument must only be connected to protective earth.
23. Do not place the instrument where it is difficult to operate the disconnecting device. (disconnecting device:
power cable)
24. The equipment may be impaired if it is used in a manner not specified by the manufacturers or manual.
25. External equipment intended for connection to signal input, signal output or other connectors of this instrument,
shall comply with relevant IEC Standard (e.g., IEC60950 for IT equipment and IEC60601-1 series for medical
electrical equipment). In addition, all such combination-system-shall comply with the standard IEC60601-1
harmonized national standard or the combination. If, in doubt, contact qualified technician or your local
representative. The operator should not touch the patient and accessible male parts of the SIP/SOP
connectors simultaneously.
26. When you carry this product, please hold on left(A) and right(B) bottom of the product.

16
27. Do not touch directly if an operator has a hand injury or a significant allergic reaction to the material used in the
operation contact part.
Part Name
Material
LCD Touch
pannel
Glass
Joystick /
button
ABS + Silicon,
Aluminum(A6061 T6)
Power switch
PC + PA66
Cover
ABS
Chin Rest
ABS

HOCT-1/1F
INTRODUCTION
3.1. System Outline
The Huvitz Optical Coherence Tomography HOCT-1, HOCT-1F is a non-contact, high-resolution
tomographic and bio-microscopic imaging device. It is indicated for in-vivo viewing, axial cross-
sectional and three dimensional imaging, color fundus imaging (HOCT-1F only) and measurement of
posterior ocular structures, including the retina, retinal nerve fiber layer, ganglion cell plus inner
plexiform layer, ganglion cell complex, macula, optic nerve head, and imaging the microvasculature of
the retina and choroid(Optional). It is also indicated for in-vivo viewing, axial cross-sectional and
three dimensional imaging of anterior ocular structures, including the cornea.
3.2. Intended Use
The HOCT-1, HOCT-1F is intended for use to aid in the diagnosis and management of ocular diseases
such as macular holes, cystoid macular edema, diabetic retinopathy and aged related macular
degeneration which are occurred at a macular, an optic disk, an inner structure of retina, and a cornea.
3.3. Classification
•Classification of product : Class II according to Annex IX (Rule 10) of the Medical Device Directive 93/42/EEC as
amended by 2007/47/EC
•Resistance against electric shock : Class I (earthed)
•Protection class against electric : Type B(Head rest, chinrest paper)
•Classification of Laser Product : Class 1 (laser based on IEC 60825-1:2014 Standard)
3.4. Contraindications
•Patients who are hypersensitive to light.
•Patients who recently underwent photodynamic therapy
•Patients taking medication that causes photosensitivity
3.5. Patient requirements
The patient who undergoes and examination by this instrument must maintain concentration for a few minutes and
adhere to the following instructions;
- After his/her face to the chinrest, forehead rest.
- Keep the eye open
- Understand and follow instructions when undergoing an examination.
If the patient does not conform to these conditions, it is not possible to take a picture correctly
3

18
3.6. Operating Principles
3.6.1. Fundus image
The anterior of an eye is illuminated by IR light, the posterior of an eye is illuminated by an infrared light and a white
LED, of which lightings are emitted by the fundus illumination optical system. The fundus observation/photography
optical system forms and makes an image with image sensors, which images are observed and manipulated with the
display panel.
3.6.2. The anterior segment/fundus tomogram
Formation of anterior chamber cross-sectional image, retinal cross-sectional image, and fundus image
To form retinal cross-sectional images (OCT images) and fundus images (OCT Phase Fundus images), the system
main body scans light over the eye to obtain interference light. The obtained interference light is dispersed into
individual wavelengths and detected by the line image sensor. The detected light is converted to signals, and then
computed to form images. With the anterior segment adapter (optional), a fundus tomogram can be formed.
3.6.3. The angiography of a retina (Optional)
To form retinal vessel maps, the system main body scans several times at the same position, and gets the same
number of tomography images. And then the system calculates the variance among those tomography, finally
projects those variances into 2D image. This projection is done at different layers which user choose.
3.7. Applied Standard List
•IEC/EN 60601-1: MEDICAL ELECTRICAL EQUIPMENT
- Part 1: General requirements for safety
•IEC/EN 60601-1-2: Medical electrical equipment Part1: General requirements for safety
- Collateral Standard: Electromagnetic Compatibility-Requirements and tests
•ISO15004-1: Ophthalmic instruments
- Fundamental requirements and test methods
General Requirements applicable to all Ophthalmic instrument
•ISO15004-2: Ophthalmic instruments-Fundamental requirements and test methods
- Part 2: Light hazard protection
•ISO 10940: Ophthalmic instruments - Fundus Cameras
•ISO 16971: Ophthalmic instruments - Optical Coherence Tomography for the posterior segment of the human eye
•IEC 60825-1: 2014: Safety of laser products – Part1: Equipment classification and requirements

HOCT-1/1F
System Overview
4.1. Configuration and Functions
Front View
No
Part
Name
Description
1
Display
LCD
Monitor for displaying captured image and user interface icon.
2
Body
Chinrest button
Button for moving chinrest up and down.
3
Joystick
Joystick for aligning body to patient’s eye.
Button for capturing image.
4
User Lock
Lock for fixing body to base frame.
5
OPT button
Button for optimizing OCT signal
6-1
6-2
Align index mark
Mark for indicating center of body and base.
7
Base
Power button
Button for turning power of internal PC on/off.
When the power is on, white light is lit.
9-1
Power switch
Switch for power on/off.
9-2
Power inlet
Inlet for connecting power cable.
10
Headrest
Eye level mark
Mark for indicating base height of patient’s eye.
11
Body
Heat vent
Window for emitting internal heat.
4
①
④
③
⑤
⑥-1
⑨
②
⑥-2
⑦
⑨-1
⑨-2
⑩
⑪

20
Rear View
No
Part
Name
Description
1
Headrest
Forehead rest
Rubber for fix patient’s head.
2
External LED
External LED for fixing patient’s eyes.
3
Chinrest
For fixing patient’s chin.
4-1
Body
Objective lens
Lens for passing illumination light from body and reflected light
from patient’s eye.
4-2
Mirering Focus LED
LEDs for checking working distance.
5
Headrest
Objective lens cap
Cap for protecting objective lens.
8
Base
External port
Port for communicating internal or external device.
8-1
RS-232 port
Port for communicating internal PC board and main board.
8-2
RGB port
Port for external display device.
8-3
DP port
Port for communicating external DP device.
8-4
LAN port
Port for external network (2 ports)
8-5
USB port
Port for internal or external USB device (4 ports)
⑧-3
⑧-4
①
①
②
③
④-1
④-2
⑧
⑧-1
⑧-2
⑧-5