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Huvitz HFC-1 Manual
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Huvitz HFC-1 Manual

Fundus camera
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REV
R-3
Applied Standard
Product Name
Model/Type
Manufacture Name
Manufacture's
Address
Trade Mark
Comment
R&D Project Leader Sang Jeon,
Prepared By
Park
Reviewed By
Q.M Manager Hyung Min, Heo
Q.M Leader Lee Chang-Soo
Approved By
Date of issue
Q-I-300-02(R1):2018/06/04
Product Description
Fundus camera
HFC-1
[Summary]
MDR 2017/745
MDD 93/42/EEC
△
2
Fundus camera
HFC-1
(with Webviewer software)
Huvitz Co.,Ltd.
38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si
Gyeonggi-Do, 14055, Republic of Korea
Homepage: www.huvitz.com
Huvitz
2020.06.08.
DOCUMENT
HQI-J-FC1-001
ES_DATE
2019-07-19
RE_DATE
2020-06-08
PAGE
1 / 36
2020.06.08
2020.06.08
2020.06.08
Huvitz Co.,Ltd

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Summary of Contents for Huvitz HFC-1

  • Page 1 DOCUMENT HQI-J-FC1-001 Product Description ES_DATE 2019-07-19 RE_DATE 2020-06-08 Fundus camera HFC-1 PAGE 1 / 36 [Summary] MDR 2017/745 Applied Standard MDD 93/42/EEC △ Product Name Fundus camera HFC-1 Model/Type (with Webviewer software) Manufacture Name Huvitz Co.,Ltd. 38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si Manufacture’s...
  • Page 2 DOCUMENT HQI-J-FC1-001 Product Description ES_DATE 2019-07-19 RE_DATE 2020-06-08 Fundus camera HFC-1 PAGE 2 / 36 ■ REVISION HISTORY DATE REVISED REASON REVISED CONTENT 2019-07-19 First issued 2020-02-13 Periodic Review Added UDI-DI number in clause 1.5) Added Medical Device Directive 2020-05-15...
  • Page 3 3 / 36 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.
  • Page 4 DOCUMENT HQI-J-FC1-001 Product Description ES_DATE 2019-07-19 RE_DATE 2020-06-08 Fundus camera HFC-1 PAGE 4 / 36 Contraindications 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 △...
  • Page 5 DOCUMENT HQI-J-FC1-001 Product Description ES_DATE 2019-07-19 RE_DATE 2020-06-08 Fundus camera HFC-1 PAGE 5 / 36 Left Right Bottom Q-I-300-02(R1):2018/06/04 Huvitz Co.,Ltd...
  • Page 6 DOCUMENT HQI-J-FC1-001 Product Description ES_DATE 2019-07-19 RE_DATE 2020-06-08 Fundus camera HFC-1 PAGE 6 / 36 (2) External Description 1) Front View ⑪ ⑩ ① ④ ② ⑤ ③ ⑥-2 ⑥-1 ⑦ ⑨ ⑨-1 ⑨-2 Part Name Description Display Monitor for displaying captured image and user interface icon.
  • Page 7 DOCUMENT HQI-J-FC1-001 Product Description ES_DATE 2019-07-19 RE_DATE 2020-06-08 Fundus camera HFC-1 PAGE 7 / 36 2) Rearview ② ④-1 ① ③ ④-2 ⑧ ⑤ ⑧-4 ⑧-3 ⑧-1 ⑧-2 ⑧-5 Part Name Description Forehead rest Rubber for fix patient’s head. Headrest External LED External LED for fixing patient’s eyes.
  • Page 8 DOCUMENT HQI-J-FC1-001 Product Description ES_DATE 2019-07-19 RE_DATE 2020-06-08 Fundus camera HFC-1 PAGE 8 / 36 RGB port Port for external display device. DP port Port for communicating external DP device. LAN port Port for external network (2 ports) USB port...
  • Page 9 DOCUMENT HQI-J-FC1-001 Product Description ES_DATE 2019-07-19 RE_DATE 2020-06-08 Fundus camera HFC-1 PAGE 9 / 36 4. GUI Interface 1) Observation screen ❶ ❷ ❸ ❹ ⓫ ❺ ❻ ❼ ❽ ❾ ⓬ ⓯ ❿ ⓭ ⓮ Name Function Shows the information of patient ID and name. Go back to patient list by clicking Patient information the icon.
  • Page 10 HQI-J-FC1-001 Product Description ES_DATE 2019-07-19 RE_DATE 2020-06-08 Fundus camera HFC-1 PAGE 10 / 36 - Stereo Disc: Capture 2 fundus images for Disc stereo analysis. △ - Widefield Panorama: Capture maximum 7 images and stitch it. Focus Move in accordance with focus of patient’s eye.
  • Page 11 Product Description ES_DATE 2019-07-19 RE_DATE 2020-06-08 Fundus camera HFC-1 PAGE 11 / 36 3) SETUP Menu [To choose the section to setup] - Setup mode consists of seven sections: System, Patient, Measure, Analysis, Report and info. You can select the section to setup from the left side.
  • Page 12 HQI-J-FC1-001 Product Description ES_DATE 2019-07-19 RE_DATE 2020-06-08 Fundus camera HFC-1 PAGE 12 / 36 Touch Keyboard Touch Keyboard ON/OFF setting. When this option is turned on, the Light is turned Objective Lens Clean on for convenient cleaning of the Objective Lens.
  • Page 13 DOCUMENT HQI-J-FC1-001 Product Description ES_DATE 2019-07-19 RE_DATE 2020-06-08 Fundus camera HFC-1 PAGE 13 / 36 Auto Import Path Assign the import path Auto Import Interval Set the interval of auto import -. Measure Settings. Auto Tracking Auto Tracking ON/OFF setting.
  • Page 14 DOCUMENT HQI-J-FC1-001 Product Description ES_DATE 2019-07-19 RE_DATE 2020-06-08 Fundus camera HFC-1 PAGE 14 / 36 -. △ Analysis Settings Apply the standard values of brightness and Fundus B/C Adjust contrast measured fundus image automatically. Apply the standard values of UB and VR to the Fundus Color Adjust measured fundus image automatically.
  • Page 15 DOCUMENT HQI-J-FC1-001 Product Description ES_DATE 2019-07-19 RE_DATE 2020-06-08 Fundus camera HFC-1 PAGE 15 / 36 5. Accessories ①Chinrest paper ②Touch pen ③Power cable ⑤Dust cover ④Fuse ⑥External LED ⑧User manual ⑨Packing lock cap ⑩Model Eye ⑦Blower Specification Accessory name Function...
  • Page 16 DOCUMENT HQI-J-FC1-001 Product Description ES_DATE 2019-07-19 RE_DATE 2020-06-08 Fundus camera HFC-1 PAGE 16 / 36 6. Specification 6.1 Device Specification Device specifications Type Non-mydriatic fundus camera Center :60 lines/mm or more Resolution Middle(r/2) :40 lines/mm or more Periphery(r) :25 lines/mm or more Angle of view 45˚...
  • Page 17 DOCUMENT HQI-J-FC1-001 Product Description ES_DATE 2019-07-19 RE_DATE 2020-06-08 Fundus camera HFC-1 PAGE 17 / 36 7. Functional Description 7.1 Block Diagram 7.2 Part’s Function General Function Drawing Part name Part Code / Name and Revision No. critical feature part(*) INLET(*)
  • Page 18 DOCUMENT HQI-J-FC1-001 Product Description ES_DATE 2019-07-19 RE_DATE 2020-06-08 Fundus camera HFC-1 PAGE 18 / 36 Color Camera for capturing color CAMERA(BFS-U3- 72030010002-A fundus fundus image 200S6C-C) camera(*) White LED illumination source for color LED(VERO 29) 71010030002-A fundus imaging Mire-ring working distance...
  • Page 19 DOCUMENT HQI-J-FC1-001 Product Description ES_DATE 2019-07-19 RE_DATE 2020-06-08 Fundus camera HFC-1 PAGE 19 / 36 7.4 Insulation Diagram Area Number Working Required Required Designed Designed Test point and type Voltage creepage clearance creepage clearance of Means (mm) (mm) (mm) (mm)
  • Page 20 DOCUMENT HQI-J-FC1-001 Product Description ES_DATE 2019-07-19 RE_DATE 2020-06-08 Fundus camera HFC-1 PAGE 20 / 36 Between secondary 2 MOOP IIIb circuit and un- earthed enclosure 1) The record was that obtained as the result of tests of certified SMPS (Report Ref. No. E356265-A11- 2) linear interpolation used 8.
  • Page 21 DOCUMENT HQI-J-FC1-001 Product Description ES_DATE 2019-07-19 RE_DATE 2020-06-08 Fundus camera HFC-1 PAGE 21 / 36 8.2 Optical System 8.2.1 Optical System Diagram 8.2.2 Components of Optical System Name and Part Code / critical feature Function Drawing Part name Revision No.
  • Page 22 DOCUMENT HQI-J-FC1-001 Product Description ES_DATE 2019-07-19 RE_DATE 2020-06-08 Fundus camera HFC-1 PAGE 22 / 36 To reflect the Color LED beam Hole Mirror and IR LED beam to the 2_HOCT-HOLE-MIRROR 8010MIR0012-A patient’s eye To check Working distance W2_OT-WD-HOLDER- W2MASSY108- W.D LED (Objective lens –...
  • Page 23 DOCUMENT HQI-J-FC1-001 Product Description ES_DATE 2019-07-19 RE_DATE 2020-06-08 Fundus camera HFC-1 PAGE 23 / 36 8.2.3 Light Paths of the System A: Col or F undus O b serv at i on channel (○ à ○ à ○ à ○...
  • Page 24 DOCUMENT HQI-J-FC1-001 Product Description ES_DATE 2019-07-19 RE_DATE 2020-06-08 Fundus camera HFC-1 PAGE 24 / 36 Dispersion Mode for checking dispersion compensation parameters Compensation Spectrometer Mode for acquiring the parameters of K-Linearization checking raw signal data Calibration with spectrometer calibrator attached.
  • Page 25 Sharpen) Fixation Led Set the parameters for Fixation Led, such as Brightness, Period. 10. Maintenance Maintenance Items To ensure safe and correct use of the HFC-1, the following must be checked before and after use.User Maintenance Items Item Period Description...
  • Page 26 If working dots isn’t fine after auto tracking, the calibration for auto tracking is needed. . Calibration is not allowed by a user because of the technical issues. Contact to the Huvitz’s authorized distributor or Huvitz Co.,Ltd. If the period of calibration is resticted by the local law, follow up the local law.
  • Page 27 DOCUMENT HQI-J-FC1-001 Product Description ES_DATE 2019-07-19 RE_DATE 2020-06-08 Fundus camera HFC-1 PAGE 27 / 36 at the time of image capture The intended part may be outside the range for image Insert a compensation lens. captures. The objective lens may be Perform the cleaning.
  • Page 28 PAGE 28 / 36 [ Replacement Chinrest paper ] NOTE Please use the chinrest paper that provided by Huvitz Co.,Ltd. Replacing fuse ① Ensure the power switch of device off (O). ② Remove power cable from inlet. ③ Pull out fuse holder in the inlet with a tweezers.
  • Page 29 2019-07-19 RE_DATE 2020-06-08 Fundus camera HFC-1 PAGE 29 / 36 Wipe them using soft cotton swab or lens cleaning paper moistened with alcohol. ④ Be careful not to use the wrong tools, so as not to damage the surface of the lens.
  • Page 30 DOCUMENT HQI-J-FC1-001 Product Description ES_DATE 2019-07-19 RE_DATE 2020-06-08 Fundus camera HFC-1 PAGE 30 / 36 Q-I-300-02(R1):2018/06/04 Huvitz Co.,Ltd...
  • Page 31 5. Others ① Cover device with dustcover for unused storage for a long time. ② Clean headrest and chinrest with alcohol before sending device to authorized agent or Huvitz for maintenance. ③ The rubber ring inserted to conceal the wires may be out during use. It can be used either by inserting it again or by removing it.
  • Page 32 AFC-330 HFC-1 The NIDEK NON-MYDRIATIC AUTO FUNDUS CAMERA, AFC-330 captures fundus images using a built- The Huvitz Fundus camera HFC-1 is in color CCD camera without the use a non-contact, bio-microscopic Indication for use of mydriatic agents. The AFC-330 is imaging device.
  • Page 33 330(W) x 542(D) x 521(H) mm Dimension(W*D*H) 29kg 28kg 12. Life time&Transportation 1) Life time : As a result of reliability test, we determined that the Life time of HFC-1 is 7 years Part/assy Part or ASSY Part code Reliability specification...
  • Page 34 DOCUMENT HQI-J-FC1-001 Product Description ES_DATE 2019-07-19 RE_DATE 2020-06-08 Fundus camera HFC-1 PAGE 34 / 36 modulation 15 minutes per 1 patient * 25 L740-36AU, Working dot, Focus 71010040005- patients per 1 day* 260 days Marubeni, 1.8V, Split LED(740nm) per 1year * 7 years = 11,375...
  • Page 35 Product Description ES_DATE 2019-07-19 RE_DATE 2020-06-08 Fundus camera HFC-1 PAGE 35 / 36 2) Environment: As a result of transportation, HFC-1 meet transportation test condition. Requimrents HAZARD Test Name Test condition No malfuction and 10℃±2, 16H performance deterioation. Environmental No malfuction and 40℃±2, 16H...
  • Page 36 DOCUMENT HQI-J-FC1-001 Product Description ES_DATE 2019-07-19 RE_DATE 2020-06-08 Fundus camera HFC-1 PAGE 36 / 36 NOISE ±2,000V 5sec per point ±500V ; Criteria C @ ±2kV HH-07 Radiation IEC 61000-4-11 Criteria A HH-06 Voltage 100%, 60%, 30%, 0.5T, 5T, 25T DIP &...