Huvitz HOCT-1F Technische Daten

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

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.

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.

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

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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