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.
