Huvitz HFC-1 - Specifications; Device Specification; Essential Performance

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 16 / 36
Q-I-300-02(R1):2018/06/04 Huvitz Co.,Ltd
6. Specification
6.1 Device Specification
Device specifications
Type Non-mydriatic fundus camera
Resolution
Center
:60 lines/mm or more
Middle(r/2) :40 lines/mm or more
Periphery(r) :25 lines/mm or more
Angle of view 45˚
Camera Color Image Sensor
Minimum pupil diameter 4.0 mm (Normal mode), 3.3 mm (Small pupil mode)
Flash light White light
Working distance 33 mm
Display 12.1 inch, 1280x800 pixel, Touch panel color LCD
Dioptric compensation for
patient’s eye
-
33D ~ +33D total
-33D ~ -7D with minus compensation lens
-13D ~ +13D with no compensation lens
+7D ~ +33D with plus compensation lens
Fixation target LCD (internal), White LED (external)
Horizontal movement 70 mm (back and forth), 100 mm (left and right)
Vertical movement 30 mm
Chinrest movement 62 mm (up and down), motorized
Auto tracking X,Y for positioning, Z for working distance
Power supply AC 100 - 240 V, 50/60 Hz, 1.6 - 0.7 A
PC Built in computer
Dimensions 330(W) x 542(D) x 521(H) mm
Mass 28 kg
6.2 Essential Performance
Essential
Performance
Associated
unacceptable risk
Failure Mode Risk Control
1. The imaging of
the fundus should
be good
1. Incorrect output
of intraocular
image
1. Intraocular
image is distorted
due to degradation
of resolution
1. An algorithm that satisfies the
following error rates is required
A. Center: more than 60 line pairs /
mm
B. Medium: more than 40 line pairs
/ mm
C. Around: more than 25 line pairs /
mm
1. 안저 이미지의
촬영이 잘 되어질
것
1. 잘못된 안구
이미지 출력
1. 해상력 저하로
인한 이미지가
왜곡되어짐
1. 아래의 오차율을 만족할 수
있는 알고리즘 필요
a. 중심: 60 line pairs/mm 이상
b. 중간: 40 line pairs/mm 이상
c. 주변: 25 line pairs/mm 이상