Huvitz HFC-1 Manuale utente
Product Description DOCUMENT HQI-J-FC1-001
ES_DATE 2019-07-19
Fundus camera
HFC-1
RE_DATE 2020-06-08
REV R-3 PAGE 1 / 36
Q-I-300-02(R1):2018/06/04 Huvitz Co.,Ltd
[Summary]
Applied Standard MDR 2017/745
△
2MDD 93/42/EEC
Product Name Fundus camera
Model/Type
H
FC
-
1
(with Webviewer software)
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 Sang Jeon,
Park 2020.06.08
Reviewed By Q.M Manager Hyung Min, Heo 2020.06.08
Approved By Q.M Leader Lee Chang-Soo 2020.06.08
Date of issue 2020.06.08.
Product Description DOCUMENT HQI-J-FC1-001
ES_DATE 2019-07-19
Fundus camera
HFC-1
RE_DATE 2020-06-08
REV R-3 PAGE 2 / 36
Q-I-300-02(R1):2018/06/04 Huvitz Co.,Ltd
■ REVISION HISTORY
NO DATE REVISED REASON REVISED CONTENT
0 2019-07-19 First issued All
1 2020-02-13 Periodic Review Added UDI-DI number in clause 1.5)
2 2020-05-15 Periodic Review Added Medical Device Directive
93/42/EEC in applied standard
3 2020-06-08 Periodic Review
Added stereo analysis description in
clause 4 due to added stereo function.
Changed UI image of analysis setting in
clause 4 due to added stereo function.
4
5
6
7
8
9
Product Description DOCUMENT HQI-J-FC1-001
ES_DATE 2019-07-19
Fundus camera
HFC-1
RE_DATE 2020-06-08
REV R-3 PAGE 3 / 36
Q-I-300-02(R1):2018/06/04 Huvitz Co.,Ltd
1. General Description
1) Indication for use:
The Huvitz Fundus camera HFC-1 is a non-contact, bio-microscopic imaging device. It is indicated for
in-vivo viewing, color fundus imaging.
2) Intended Use
A device that illuminates the fundus by entering light into the pupil and photographs the fundus state
according to the reflected light.
Figure 1. Fundus camera HFC-1
3) User profile
The equipment must be operated only by a, or under direct supervision of properly trained and
qualified person/s such as ophthalmologist.
a. Age: adult (> 21 years of age)
b. Occupation: Optometrist, ophthalmologist
c. Level of training: Recommend completing training how to use it is.
d. Education: Basic training is required for the use of equipment. (Obtains a certificate of qualification
such as optics, medical school, etc., after completing a certain amount of education.)
4) Patient Profile
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, headrest.
- 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
a. Age: not relevant
b. Weight / Height: not relevant
c. Health: not relevant
d. Nationality: multiple
e. Patient state: not relevant
- HFC-1 should be used for all patients who need eye-examination in compliance with the
contraindications.
Product Description DOCUMENT HQI-J-FC1-001
ES_DATE 2019-07-19
Fundus camera
HFC-1
RE_DATE 2020-06-08
REV R-3 PAGE 4 / 36
Q-I-300-02(R1):2018/06/04 Huvitz Co.,Ltd
C
ontraindications
This device should not be used for:
•Patients who are hypersensitive to light.
•Patients who recently underwent photodynamic therapy
•Patients taking medication that causes photosensitivity
△
15) UDI Information
Basic UDI-DI: 08800019600541
2. Dimension and weight
-. Dimension: 330(W) x 542(D) x 521(H) mm
-. Weight: 28kg
3. Photo View
(1) External Picture
Front Rear
Product Description DOCUMENT HQI-J-FC1-001
ES_DATE 2019-07-19
Fundus camera
HFC-1
RE_DATE 2020-06-08
REV R-3 PAGE 5 / 36
Q-I-300-02(R1):2018/06/04 Huvitz Co.,Ltd
Left Right
Bottom
Product Description DOCUMENT HQI-J-FC1-001
ES_DATE 2019-07-19
Fundus camera
HFC-1
RE_DATE 2020-06-08
REV R-3 PAGE 6 / 36
Q-I-300-02(R1):2018/06/04 Huvitz Co.,Ltd
(2) External Description
1) 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 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.
①
④
③⑤
⑥-1
⑨
②
⑥-2
⑦
⑨-1 ⑨-2
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Product Description DOCUMENT HQI-J-FC1-001
ES_DATE 2019-07-19
Fundus camera
HFC-1
RE_DATE 2020-06-08
REV R-3 PAGE 7 / 36
Q-I-300-02(R1):2018/06/04 Huvitz Co.,Ltd
2) Rearview
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.
⑧-4
①
③
②
④-1
⑤
④-2
⑧
⑧-3
⑧-1
⑧-2
⑧-5
Product Description DOCUMENT HQI-J-FC1-001
ES_DATE 2019-07-19
Fundus camera
HFC-1
RE_DATE 2020-06-08
REV R-3 PAGE 8 / 36
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)
3) Bottom View
No Part Name Description
1 Base Packing lock Lock for fixing body and base during transportation. (2 points)
①
Product Description DOCUMENT HQI-J-FC1-001
ES_DATE 2019-07-19
Fundus camera
HFC-1
RE_DATE 2020-06-08
REV R-3 PAGE 9 / 36
Q-I-300-02(R1):2018/06/04 Huvitz Co.,Ltd
4. GUI Interface
1) 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.
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 FIXATION BR Control Fixation brightness.
11 Capture mode
Select capture mode.
- Single Macular: Capture one fundus image for Macular.
- Single Disc: Capture one fundus image for Optic Disc.
△
3- Stereo Macular: Capture 2 fundus images for Macular stereo analysis.
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⓫
❶❷❸
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⓬
❿
❹
❾
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⓯
Product Description DOCUMENT HQI-J-FC1-001
ES_DATE 2019-07-19
Fundus camera
HFC-1
RE_DATE 2020-06-08
REV R-3 PAGE 10 / 36
Q-I-300-02(R1):2018/06/04 Huvitz Co.,Ltd
△
3- Stereo Disc: Capture 2 fundus images for Disc stereo analysis.
- Widefield Panorama: Capture maximum 7 images and stitch it.
12 Focus Move in accordance with focus of patient’s eye.
13 IR.En Change brightness of IR fundus image
14 Flash Change brightness level of white light for capturing fundus image.
15 Optimize Find focus position automatically by split focus image.
2) Confirmation screen
No Name Function
1 Image selection
Decide validity of current image.
- OK: Save current image.
- RETRY: Discard current image and retry capturing.
2 Analyze Save the camera DATA and enter the analysis screen
3Fundus
information Display setting information of fundus image.
4 Fundus image Show captured fundus image.
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Altri manuali per HFC-1
1
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