Huvitz HOCT-1F Especificaciones técnicas
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
RE_DATE 2020-01-30
REV R-3 PAGE 4 / 52
Q-I-300-02(R1):2018/06/04 Huvitz Co.,Ltd
3. Photo View
(1) External Picture
-. Front
-. Rear
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 5 / 52
Q-I-300-02(R1):2018/06/04 Huvitz Co.,Ltd
-. 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
REV R-3 PAGE 6 / 52
Q-I-300-02(R1):2018/06/04 Huvitz Co.,Ltd
(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
REV R-3 PAGE 7 / 52
Q-I-300-02(R1):2018/06/04 Huvitz Co.,Ltd
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
REV R-3 PAGE 8 / 52
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
REV R-3 PAGE 9 / 52
Q-I-300-02(R1):2018/06/04 Huvitz Co.,Ltd
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
REV R-3 PAGE 10 / 52
Q-I-300-02(R1):2018/06/04 Huvitz Co.,Ltd
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
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