Huvitz HOCT-1F Technical specifications

Product Description DOCUMENT HQI-J-OT1-001
ES_DATE 2017-11-01
Optical Coherence Tomography
HOCT-1F, HOCT-1
RE_DATE 2020-01-30
REV R-3 PAGE 1 / 52
Q-I-300-02(R0) Huvitz Co.,Ltd
[Summary]
Applied Standard MDD 93/42/EEC
Product Name Optical Coherence Tomography
Model/Type
Optical Coherence Tomography
HOCT-1F, HOCT-1
Manufacture Name Huvitz Co.,Ltd.
Manufacture’s
Address
38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si
Gyeonggi-Do, 14055, Republic of Korea
Homepage: www.huvitz.com
Trade Mark Huvitz
Comment
Prepared By R&D Project Leader Jin Wook, Shon 2020.01.30
Reviewed By Q.M Manager Hyung Min, Heo 2020.01.30
Approved By Q.M Leader Lee Chang-Soo 2020.01.30
Date of issue 2020. 01.30 .

Product Description DOCUMENT HQI-J-OT1-001
ES_DATE 2017-11-01
Optical Coherence Tomography
HOCT-1F, HOCT-1
RE_DATE 2020-01-30
REV R-3 PAGE 2 / 52
Q-I-300-02(R1):2018/06/04 Huvitz Co.,Ltd
■ REVISION HISTORY
NO DATE REVISED REASON REVISED CONTENT
0 2017-11-01 First issued All
1 2018-08-20 Periodic Review Corrected typo error of intended use in
clause 5.2
2 2019-07-02 Periodic Review
Updated clause 4, 6, 7, 8, 9, 10 and 11
due to added web-viewer software and
angio function
3 2020-01-30 Periodic Review Added form number due to revised form
4
5
6
7
8
9

Product Description DOCUMENT HQI-J-OT1-001
ES_DATE 2017-11-01
Optical Coherence Tomography
HOCT-1F, HOCT-1
RE_DATE 2020-01-30
REV R-3 PAGE 3 / 52
Q-I-300-02(R1):2018/06/04 Huvitz Co.,Ltd
1. General Description
1.1 Indication for Use
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
1.2 △
1Intended 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.
Figure 1. Optical Coherence Tomography HOCT-1F, HOCT-1
2. Dimension and weight
-. Dimension: 330(W) x 542(D) x 521(H) (mm)
-. Weight: 30.0kg

Product Description DOCUMENT HQI-J-OT1-001
ES_DATE 2017-11-01
Optical Coherence Tomography
HOCT-1F, HOCT-1
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3. Photo View
(1) External Picture
-. Front
-. Rear

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ES_DATE 2017-11-01
Optical Coherence Tomography
HOCT-1F, HOCT-1
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-. Left
-. Right
-. Bottom

Product Description DOCUMENT HQI-J-OT1-001
ES_DATE 2017-11-01
Optical Coherence Tomography
HOCT-1F, HOCT-1
RE_DATE 2020-01-30
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(2) External Description
1) Front View
Part Name Description
1 Display LCD Monitor for displaying captured image and user interface icon.
2
Body
Chin rest
button Button for moving chin rest 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 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.
8 External port Port for communicating internal or external device.
8-1 RS-232 port Port for communicating internal PC board and main board.

Product Description DOCUMENT HQI-J-OT1-001
ES_DATE 2017-11-01
Optical Coherence Tomography
HOCT-1F, HOCT-1
RE_DATE 2020-01-30
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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)
9-1 Power switch Switch for power on/off.
9-2 Power inlet Inlet for connecting power cord.
10 Headrest Eye level mark Mark for indicating base height of patient’s eye.
11 Body Heat vent Window for emitting internal heat.
2) Rearview
Part Name Description
1
Headrest
Forehead rest Rubber for fix patient’s head.
2 External fixation 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 Mire ring
Focus LED LEDs for checking working distance.
5 Headrest Objective lens cap Cap for protecting objective lens.

Product Description DOCUMENT HQI-J-OT1-001
ES_DATE 2017-11-01
Optical Coherence Tomography
HOCT-1F, HOCT-1
RE_DATE 2020-01-30
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Q-I-300-02(R1):2018/06/04 Huvitz Co.,Ltd
3) Bottom View
Part Name Description
1 Base Packing lock Lock for fixing body and base during transportation. (2 points)

Product Description DOCUMENT HQI-J-OT1-001
ES_DATE 2017-11-01
Optical Coherence Tomography
HOCT-1F, HOCT-1
RE_DATE 2020-01-30
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4. GUI Interface
①OCT/Fundus mode (HOCT-1F only)
Observation screen
Name Description
1Patient
information
Show patient name and ID number.
Can be moved to select/resist patient mode by clicking.
2Observation
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
12 Scan range Toggle whether scan range is displayed or not.

Product Description DOCUMENT HQI-J-OT1-001
ES_DATE 2017-11-01
Optical Coherence Tomography
HOCT-1F, HOCT-1
RE_DATE 2020-01-30
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13 Reset scan
position Reset scan position to center.
14 Focus Move in accordance with focus of patient’s eye.
15 Ref.M Move reference mirror position for OCT scan.
16 Flash Change brightness level of white light for capturing fundus image.
17 Scan Start Start OCT scan.
18 Scan direction Horizon, vertical changes are possible
Confirmation screen
(Refer OCT/Fundus mode – Observation screen’ for uncommented item)
Name Description
1 Image selection
Decide validity of current image.
- OK: Save current image.
- RETRY: Discard current image and retry capturing.
2 Scan range Show OCT scan range.
3 Scan position Show scan position of current OCT scan image displayed on the
right.
4Move scan
position Change previous/next OCT scan image.
5 Play image Display captured OCT scan image continuously.
6 SSI Show quality index of scan image.
7 Scan information Display setting information of scan image.
8 Fundus image Show captured fundus image.
9 OCT image Show captured OCT image.
10 Analyze Save the camera DATA and enter the analysis screen

Product Description DOCUMENT HQI-J-OT1-001
ES_DATE 2017-11-01
Optical Coherence Tomography
HOCT-1F, HOCT-1
RE_DATE 2020-01-30
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OCT mode
Observation screen
(Refer. OCT/Fundus mode – Observation screen’ for uncommented item)
Name Description
1 Signal Level Mode can be changed
Confirmation screen
(Refer OCT/Fundus mode – Confirmation screen’ for uncommented item)

Product Description DOCUMENT HQI-J-OT1-001
ES_DATE 2017-11-01
Optical Coherence Tomography
HOCT-1F, HOCT-1
RE_DATE 2020-01-30
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Fundus mode (HOCT-1F only)
Observation screen
(Refer OCT/Fundus mode – Observation screen’ for uncommented item)
Name Description
1 Capture mode
Select capture mode.
- Single: Capture one fundus image.
- Panorama: Capture maximum 7 images and stitch it.
2 IR.En Change brightness of fundus image
3 Optimize Find focus position automatically by split focus image.
Confirmation screen
(Refer OCT/Fundus mode – Confirmation screen’ for uncommented item)
Name Description
1 Fundus information Display setting information of fundus image.

Product Description DOCUMENT HQI-J-OT1-001
ES_DATE 2017-11-01
Optical Coherence Tomography
HOCT-1F, HOCT-1
RE_DATE 2020-01-30
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△
2Angio Mode (Optional)
Observation screen
(Refer. OCT/Fundus mode – Observation screen’ for uncommented item)
No Name Function
1 Signal Level Mode can be changed
Confirmation screen
(Refer ‘4.2.1. OCT/Fundus mode – Confirmation screen’ for uncommented item)
No Name Function
1 Superficial ILM - IPL
2 Deep IPL - OPL
3 Outer OPL - IOS
4 Choroicapiliary From BRM Depth 30um
❶
❷ ❸ ❹
❶

Product Description DOCUMENT HQI-J-OT1-001
ES_DATE 2017-11-01
Optical Coherence Tomography
HOCT-1F, HOCT-1
RE_DATE 2019-07-02
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△
2Webviewer Software
Patient Information Screen
1Shows the patient list saved in the HUVITZ WebViewer database currently. New patient gets added into the
patient list when new patient information is transmitted at the HUVITZ’s ophthalmic device or when patient is added
on using ‘Add Patient’ in the WebViewer. When mouse is placed on top of the patient list, URL copy icon that
enables move to the applicable patient immediately, gets activated.
2Outputs detailed information on the selected patient. Displays information such as patient ID, name, age, gender,
ethnicity, eyesight (refractive index), operator and doctor in charge.
3Outputs inspection list on the selected patient. Moves to the Analysis Screen of the selected inspection when
double clicked.
4In case of the inspection that is transmitted from and in progress in the equipment “Loading…” message is
displayed. Inspection that is being transmitted and in progress gets completed, and when the Loading message
disappears, it is possible to move to the Analysis Screen.
5When the mouse is placed on top of the inspection list, URL copy icon that enables immediate move to the
applicable inspection and delete inspection icon is activated.
6Outputs summary information on the selected inspection. Moves to the Analysis Screen when ‘Analyze’ button is
clicked on.
7Only the inspection measured today is output when ‘Today’ button is clicked on. Able to add patient when ‘Add
Patient’ button is clicked on.
8By clicking the Refraction button, processed examination list will be shown. And it can be saved as its patient’s own

Product Description DOCUMENT HQI-J-OT1-001
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Optical Coherence Tomography
HOCT-1F, HOCT-1
RE_DATE 2019-07-02
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examination. The button is shown when choosing patient.
9Information on the software version is displayed. When user icon is pressed on, ID logged-in currently is displayed,
and it is possible to log-out when log-out button is pressed on.
Analysis Screen Overview
1Summary: Shows summary information on the results of measuring one eye. This tab is selected by default.
2OU: Able to carry out comparative analysis on the measurement data on the both eyes.
3Progression: Able to carry out comparative analysis with the various previous data using the currently selected data
as the standard.
4Comparison: Able to carry out comparative analysis on the data of the measurement part that is the same as that
of the currently selected data using a different date.
53D: Shows 3D modeling image using image of measured result.
6URL that can move immediately to the current inspection is copied.
7Export the current inspection data as zip.
8Displays the screen where Comment can be input. When Enter button input, menu modification and COMMENT
button are pressed once again, Comment is saved. Input contents are output to the comment category at the
report’s lower part.
9Report on the result displayed currently is saved as pdf or jpg.
10 Current screen is saved as pdf.
11 Recalculate the current inspection data

Product Description DOCUMENT HQI-J-OT1-001
ES_DATE 2017-11-01
Optical Coherence Tomography
HOCT-1F, HOCT-1
RE_DATE 2019-07-02
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5. Accessories
①Chinrest paper ②Touch pen ③Power cable ④Fuse ⑤Dust cover
⑥External LED ⑦Blower ⑧User manual ⑨Packing lock cap ⑩Model Eye
⑪Anterior headrest
rubber (optional)
⑫Anterior
segment adapter
(optional)
No. Accessory name Function Specification Quantity
1 Chinrest paper Spare parts Material: paper, Finish: natural
Size: 130 x 40 x 0.05mm, 1 unit
2 Touch pen LCD Touch pen ф11 x 128mm, ф4.8 x 95mm 1 unit
3 Power cable
Connect the device to
power line
(Detachable) Rated 10 A, 250V. Plug
type CEE7, Connector type IEC
60320/C13, and Cord type H05VV-
F3G, min. 0.75 mm2, 3-conductor
terminating in molded-on grounding
type attachment plug. <HAR>
marked on the cord. Maximum 2.5 m
long.
1 unit
4 Fuse Spare parts 250V, T 3.15AL 2 units
5 Dust cover
Covering the device when
is unused
Size: 340*560*530mm
Material: Hanibon PD3085LAIN
1 unit
6 External LED
External LED for fixing
patient’s eyes.
ф17 x 392mm
1 unit
7 Blower
removing dust on the
surface of lens
ф55 x 153mm
1 unit

Product Description DOCUMENT HQI-J-OT1-001
ES_DATE 2017-11-01
Optical Coherence Tomography
HOCT-1F, HOCT-1
RE_DATE 2019-07-02
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8 User manual Instruction for use
A4 1
volume
9 Packing lock cap
a cap that unlocks and
covers the hall
ф17.0 x 4.6mm
1 unit
10 Model Eye
Self-diagnosis using Model
eye
108 x 33 x 103mm
1 unit
11
Anterior headrest
rubber (optional)
Connecting to headrest of
instrument for anterior
image
133 x 49 x 64mm
1 unit
12
Anterior segment
adapter
(optional)
Connecting adaptor to
objective lens for anterior
image
∅
38 x 50mm
1 unit

Product Description DOCUMENT HQI-J-OT1-001
ES_DATE 2017-11-01
Optical Coherence Tomography
HOCT-1F, HOCT-1
RE_DATE 2019-07-02
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6. △
2Specification
6.1 Device Specification
OCT
Principle Spectral domain OCT, Fundus digital photography
Light source 840 nm
Scan speed Max. 68,000 A-scan/sec.
Resolution in tissue 20 um(Lateral), 6~7 um(z-axis) at index 1.36
Scan Range X: 6 ~ 12 mm, Y: 6 ~ 9 mm, Z: 2.34 mm
Display resolution X: 5.85 um, Y: 23.40 um, Z: 3.05 um
Minimum pupil diameter 2.5 mm
Scan patterns Macular: Macular Line, Macular Cross, Macular Radial, Macular 3D, Macular Raster
Disk: Disc Circle, Disc Radial, Disc 3D, Disc Raster
Optical power at cornea ≤ 650 uW
Acquisition time of 3D
image 1.4 sec. (Normal mode, A512 x B96)
Depth Accuracy
(measuring 1mm glass) ±3%
△
2Angiography Range X:3 ~ 12mm, Y:3~9mm (Optional)
△
2Angiography Analysis FAZ, Vessel density Tools (Optional)
Fundus Camera (HOCT-1F/HOCT-1FA)
Type Non-mydriatic fundus camera
Resolution 60 line pair/mm (centre), 40 line pair/mm (middle), 25 line pair/mm (periphery)
Angle of view 45˚
Camera Built-in 20Mega pixel, Color
Minimum pupil diameter 4.0 mm (Normal mode), 3.3 mm (Small pupil mode)
Flash light White light, 10 levels
Pixel pitch at fundus 3.69 um
Common specification
Working distance 33 mm
Display 12.1 inch, 1280x800 pixel, Touch panel color LCD
Dioptric compensation for
patient’s eye
-33D ~ +33D total
-13D ~ +13D with no compensation lens
+7D ~ +33D with plus compensation lens
-33D ~ -7D with minus compensation lens
Internal fixation target LCD (internal), White LED (external)
Fundus illumination light 760 nm
Horizontal movement 70 mm (back and forth), 100 mm (left and right)
Vertical movement 30 mm
Chin rest movement 62 mm (up and down), motorized
Auto tracking 30mm (up and down), 10 mm (right and left), 10mm (back and forth)
Power supply AC 100 - 240 V, 50/60 Hz, 1.6 - 0.7 A
PC Built in computer
LCD Tilting Angle 70˚
External port 2 USB, 1 DP, 1 RGB, 2 LAN
Dimensions 330(W) x 542(D) x 521(H) mm
Mass 30 kg
Anterior segment adapter (optional)
Working distance 15 mm
Scan range 6 ~ 9 mm (width), 2.3 mm (depth)
Scan pattern ACA line, Anterior Radial, Anterior 3D

Product Description DOCUMENT HQI-J-OT1-001
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Optical Coherence Tomography
HOCT-1F, HOCT-1
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6.2 △
2Essential Performance
Model Essential
Performance
Associated
unacceptable risk Failure Mode Risk Control
HOCT-1 The scanning of the
tomographic
image should be
good
Measurement error
between thickness
of layers of
intraocular
The tomographic
image is distorted
for the X, Y, and Z
axes
An algorithm
that satisfies the
following error
rates is required
a. Scan width (X
Axis): 6±5% -
12mm±5%
b. Scan width (Y
Axis): 6±5% -
9mm±5%
c. Scan depth (Z
Axis):
2.34mm±5%
HOCT-1F 1. The scanning of
the tomographic
image should be
good
2. The imaging of
the fundus should
be good
1. Measurement
error between
thickness of layers
of intraocular
2. Incorrect output
of intraocular
image
1. The tomographic
image is distorted
for the X, Y, and Z
axes
2. Intraocular image
is distorted due to
degradation of
resolution
1. An algorithm
that satisfies the
following error
rates is required
a. Scan width (X
Axis): 6±5% -
12mm±5%
b. Scan width (Y
Axis): 6±5% -
9mm±5%
c. Scan depth (Z
Axis):
2.34mm±5%
2. An algorithm
that satisfies the
following error
rates is required
A. Center: more
than 60 line
pairs / mm
B. Medium:
more than 40
line pairs / mm
C. Around: more
than 25 line
pairs / mm
△
27. Functional Description

Product Description DOCUMENT HQI-J-OT1-001
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7.1 Functional block diagram
7.2 Part’s Function
No. General Name
and critical
feature part(*)
Function Drawing Part name Part Code /
Revision No.
1 INLET(*) Input power: 100-240vac
50/60Hz
AC INLET FILTER(CIT-
FUSE,0215005.MXP)
79050010004
2 Power switch(*) Turn on or Turn off the device SWITCH(ON-OFF) 76010010002
3 FUSE(*) 50T, 250V, 3.15A rated fuse Fuse 7610S005031
4 SMPS(*) Convert the AC power to DC
output
SMPS(DELTA 400W) 75010010008-A
5 Main control
B/D(*)
Signal processing
Control of LED and Sensor,
Motor
PCB ASSY(MAIN-111) W2EPCB0001-
AB
6 Auto alignment
interface B/D
XYZ stage motor driver B/D PCB ASSY(AAM-200) W2EPCB0010-
AA
7 Joystick ASSY Joystick for moving head optics
and capturing images by
pressing capture button.
A8-JOYSTICK-ASSY A8MASSY005-
AD
8 Base interface
B/D
DC power distribution and
control signal router.
PCB ASSY(BASE IF-110) W2EPCB0016-
AB
9 Head Rest
ASSY
chinrest for patients W2_HR-HEAD-REST-
ASSY
W2MASSY006-
AA
10 Embedded PC
B/D
computer unit for GUIs and
control
PC MOTHER BOARD 79990010022-A
11 Color fundus
camera(*)
Camera for capturing color
fundus image
CAMERA(BFS-U3-
200S6C-C)
72030010002-A
12 White LED illumination source for color
fundus imaging
LED(VERO 29) 71010030002-A
13 Mire-ring LED working distance measurement IR LED(940NM) 71010040006-A
14 Cornea Camera camera for working distance
measurement and cornea
preview
PCB ASSY(CMOS
AR0130)
M2EPCB0007-
AA