Huvitz HOCT-1F/1 User manual

OPTICAL COHERENCE
TOMOGRAPHY
HOCT-1F/1
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
${appDate1}
${app1}
First issued
9000ENG0040-A
(2018/01/10)
©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.

3
HOCT-1F/1
CONTENT
1SAFETY PRECAUTIONS.............................................................................................................5
1.1. Overview ...........................................................................................................................................................5
2Symbol Information....................................................................................................................6
2.1. Usage Precautions ...........................................................................................................................................8
2.2. Environmental Considerations ....................................................................................................................... 11
2.3. Safety Precautions..........................................................................................................................................13
3INTRODUCTION........................................................................................................................15
3.1. System Outline................................................................................................................................................15
3.2. Intended Use...................................................................................................................................................15
3.3. Classification ...................................................................................................................................................15
3.4. Contraindications ............................................................................................................................................15
3.5. Patient requirements.......................................................................................................................................15
3.6. Operating Principles .......................................................................................................................................16
3.6.1. Fundus image...............................................................................................................................................................................16
3.6.2. The anterior segment/fundus tomogram......................................................................................................................16
3.7. Applied Standard List......................................................................................................................................16
4System Overview......................................................................................................................17
4.1. Configuration and Functions ..........................................................................................................................17
4.2. Main Body Screen Description .......................................................................................................................20
4.2.1. OCT/Fundus mode (HOCT-1F only) .................................................................................................................................20
4.2.2. OCT mode......................................................................................................................................................................................23
4.2.3 Fundus mode (HOCT-1F only)..............................................................................................................................................24
5Installation Procedure ..............................................................................................................25
5.1. System installation ..........................................................................................................................................25
6Operation..................................................................................................................................28
6.1. Software ..........................................................................................................................................................28
6.2. SETUP Mode ..................................................................................................................................................30
6.3. General Operation ..........................................................................................................................................33
6.4. Anterior segment image operation (optional).................................................................................................45
6.4.1. Preparation for anterior segment operation................................................................................................................45
6.4.2. Capturing anterior segment .................................................................................................................................................46
6.5. Analyze............................................................................................................................................................51
6.5.1. Entering Analysis screen .........................................................................................................................................................51
6.5.2. OCT Macular 3D Analysis screen .......................................................................................................................................52
6.5.3. OCT Disc 3D Analysis screen ...............................................................................................................................................63
6.5.4. OCT Anterior Line Analysis screen ....................................................................................................................................74
6.5.5. Fundus Analysis screen ...........................................................................................................................................................82
6.6. Maintenance....................................................................................................................................................91
6.6.1. After operation ............................................................................................................................................................................91
6.6.2. Cleaning...........................................................................................................................................................................................93
6.6.3. Replacement of consumables and fuse..........................................................................................................................94
6.6.4. Calibration ......................................................................................................................................................................................94
6.6.5. Self-diagnosis using Model eye..........................................................................................................................................95
7Troubleshooting Guide.............................................................................................................99
8Specifications and Accessories.............................................................................................100
8.1. Standard Accessories ...................................................................................................................................100
8.2. Specifications ................................................................................................................................................101
8.3. Drawings of System ......................................................................................................................................102

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9EMC INFORMATION................................................................................................................103
10 SERVICE INFORMATION ........................................................................................................105
11 SOFTWARE LICENSE AGREEMENTS....................................................................................106

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HOCT-1F/1
1 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

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2 Symbol Information
The International Electro technical 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.
I and O on power switch represent ON and OFF respectively.
Type B Isolated patient connection.
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.
Identifies the point where the system safety ground is fastened to the
chassis. Protective earth connected to conductive parts of Class I equipment
for safety purposes.
Indicates the Manufacturer
Indicates the date of manufacture
Authorized Representative in the European Community
Temperature Limitation
Keep DRY
Warning: Crushing or insert of hand
UL Mark
CE Mark
2

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HOCT-1F/1
Class I Laser Product
CE for RoHS
RoHS Directive Compliance 2011/65/EU
WEEE
indicating separate collection for electrical and electronic equipment

8
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

9
HOCT-1F/1
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

10
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

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HOCT-1F/1
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

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Be careful not to block the fan of the instrument.
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.

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HOCT-1F/1
2.3. Safety Precautions
1. This is an electric medical device. Use is 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. 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.
5. 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.
6. The instrument must be operated by a trained and qualified person or under his or her supervision.
7. Repair of this instrument must be conducted by HUVITZ’s service technicians or other authorized
persons.
8. 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.
9. 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.
10. 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.
11. 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.
12. Only those who have undergone proper training and instructions are authorized to install, use, operate,
and maintain this instrument.
13. Keep the User’s Manual and Service Manual in a place easily accessible at all times for persons
operating and maintaining the equipment.

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14. 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.
15. Please do not pull on any cable. Always grab the plug when disconnecting cables.
16. Before you use, check the exterior of the instrument and its conditions.
17. Do not block any ventilation outlet necessary for proper heat dissipation.
18. 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.
19. 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.
20. To avoid the risk of electric shock, this instrument must only be connected to protective earth.
21. Do not place the instrument where it is difficult to operate the disconnecting device. (disconnecting
device: power cable)
22. The equipment may be impaired if it is used in a manner not specified by the manufacturers or manual.
23. 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.
24. When you carry this product, please hold on left(A) and right(B) bottom of the product.

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HOCT-1F/1
3 INTRODUCTION
3.1. System Outline
The Huvitz Optical Coherence Tomography HOCT-1F, HOCT-1 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. 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-1F, HOCT-1 is intended for use as a diagnostic device to aid in the check and
management of ocular diseases such as macular holes, cystoid macular edema, diabetic retinopathy,
aged related macular degeneration, and so on, 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

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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
3.7. 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

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HOCT-1F/1
4 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

18
Rear View

19
HOCT-1F/1
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)
Bottom View
No
Part
Name
Description
1
Base
Packing lock
Lock for fixing body and base during transportation. (2 points)

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4.2. Main Body Screen Description
4.2.1. OCT/Fundus mode (HOCT-1F only)
Observation screen
No
Name
Function
1
Patient information
Shows the information of patient ID and name. Go back to patient
list by clicking the icon.
2
Observation mode
Show current observation mode.
- OCT/Fundus: Capture OCT and Fundus image
simultaneously.
- OCT: Capture OCT image.
- Fundus: Capture Fundus image.
3
OD/OS
Show current eye position.
- OD: right eye
- OS: left eye
4
AUTO S
Show auto shooting selection status.
5
AUTO T
Show auto tracking selection status.
6
FIXATION
Select position of internal fixation target.
7
C LENS
Show compensation lens status.
0: No compensation lens is used.
-: Minus compensation lens is used.
+: Plus compensation lens is used.
8
IR-ILL
Select brightness level of IR light for fundus observation.
Normal / Bright mode is toggled by clicking.
9
S.Pupil
Show small pupil mode selection status for fundus image.
10
SETUP
Move to user setup mode.
11
Capture region
Select capture region and capture mode
- Fundus/OCT or OCT mode: Macular, Disk, Anterior
- Fundus mode: Single, Panorama
❶
❷
❸
❺
❻
❼
❽
⓲
⓬
⓰
❿
❹
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⓫
⓭
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