EDAN Agile PLM Electronic Signature Information
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文件名称(Document Name)：C6A HD&C6A&C3A-TF03- Product
Description
文件编号(Number)：EDAN-MDD-2212A-1-D0003
版本(Version)：1.6
产品型号(Product Model)：C6A HD;C3A;C6A
项目编码(Project Code)：2212A-1000
签批信息(Signature):
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作者(Originator) : 吴 国杰 (wuguojie) 2021-02-25 14:01:18
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审核人(Reviewers) : 杨 洁 (yangjie) 2021-02-25 14:59:36
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批准人(Approvers) : 章 鸿 (zhanghong) 2021-02-25 15:30:30
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版权©深圳市理邦精密仪器股份有限公司 (Copyright©Edan Instrument,Inc.)
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EDAN INSTRUMENTS, INC.
C6A HD&C6A&C3A -TF03-Product Description
1. Introduction of Edan Instruments, Inc.
Edan Instruments Inc. was founded in Shenzhen, China in 1995 by a team of engineers, medical professionals and
marketing experts. Now Edan has become one of the leading medical equipment manufacturers in China. The
company has developed five product lines, including Obstetrical and Gynecological product line, Diagnostic
Electrocardiograph product line, Patient Monitoring product line, Ultrasound Imaging product line and In-Vitro
Diagnostic product line.
EDAN is dedicated to technology leadership, precise manufacture and uncompromised quality attestation. The
company obtained ISO 9001 and EN 46001 quality system certification in 2001 from TUV SUD. Most of the
company’s products have obtained CE marking and medical device licence from Health Canada, and many
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products have received 510(k) clearance.
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2. Description of Video Colposcope
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2.1 Introduction
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The software version and hardware version of the Video Colposcope are 1.57/1.29 .
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The video colposcope is a device of function of general survey, diagnosis, assisting treatment for gynecological
cervix, vagina and vulva disease. It integrates the digital image theory with the multi-media computer technology.
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The system adopts camera lens device which imaging in focus, well and truly, zoom in and large LCD display to
find focus. The professional Colposcope software system includes freeze image, capture image, store image,
compare and analysis and print function and so on. The video colposcope is a great convenience clinic checking
and ideal gynaecology tool.
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Accessory list:
Accessories Type Part number Manufacturer CE mark
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Power Adapter FW7556M/12 21.21.064212 FRIWO CE
FS-81-SP-2-LB- CE
Foot Swtich 21.10.027168 SUNS
H
/ CE
Power Plug (Europe) 01.12.032101 FRIWO
USB&DC cable / 01.13.036677-10 Changke -
/ -
S-VIDEO cable 01.13.036657-10 Yuanhe
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USB cable 01.13.036779
HDMI standard cable / 01.13.037307 /
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(for C6A HD) /
ME20A1202F0 CE
Power Adaptor 01.21.064361 SL
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There are two types of video colposcopes for privately operated hospitals:C300A and iHC3A. Compared with
C3A, only their silk screen and label are different.
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Configuration C3A C6A C6A HD
Led light source(24) √ X X
C3A Led light source(40) ● X X
镜 SMD led light source(12) ● X X
Camera Led light source(40) X √ X
C6A
SMD led light source(12) X ● X
C6A HD SMD led light source(12) X X √
支 Upright Arm √ √ √
Arm Swing Arm ● ● ●
Standard-definition video captur √ √ X
High-definition video capture X X √
Note：
“×” No such configuration,“√” Standard Configuration， “●”Optional
Manufacturer suggests that the lifetime of the Video Colposcope is 10 years.
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2.2 Intended Use
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The C3A, C6A and C6A HD video colposcope is intended for gynecological examination. It provides magnified
visualization of the vagina, cervix and external genitalia, which can help diagnose abnormalities and select areas
for biopsy. It is intended to be used only by trained and qualified personnel in hospitals, clinics and private offices,
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and not intended for home use or to touch the patient.
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2.3 Principle of Operation
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Video colposcope is posed by the digital imaging technology and multimedia computer technology to combine a
gynecological cervical, vaginal, vulvar diseases of the Census and auxiliary inspection equipment. The video
colposcope includes camera, capture moduleand DC adapter. Camera is composed of a integrated camera module,
the ring LED lights and the camera module which controlling the camera. The system adopts SONY color camera
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integration module which uses close-up lens in the lens.
The characteristics of close-up lens: It raised the front to magnify the image, while the back is slightly recessed to
a certain extent, reduce the curved image field. Attach a close-up lens before the standard lens, its focal length will
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change immediately.
Usually close-up lens uses diopter to calibrate, for example：+1、+2、+3 and so on. Diopter greater the
magnification is higher, the shorter the focal length。
The system uses the type of +3 close-up lens, focus 300mm at distance.
SONY color camera integrated module of the objective lens of the zoom lens is the lens of a focal length can be
adjusted automatically. The objective lens focal length can change continuously within a certain range, therefore
the continuous changes in the objects of a certain distance from the imaging magnification within a certain range,
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but the surface location of the system remain unchanged, the surface location in the module is fixed to the CCD or
COMS sensor devices. The zoom system is consists of multiple subsystems. The focal length change is achieved
through the axial movement of one or more subsystems, to change the light group interval.
According to the lens imaging principle, to get a clear image on the image plane by the convergence in the camera
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module lens must be a real image. So the real image must be other than two times the focal length. If the distance
of real image is Infinity, the incident light can be approximated as a parallel light, At this time the goal of infinity
on the image on the image plane。The close-up lens is function of magnifying. Target first through the lens
imaging at infinity, then image on the camera through the optical lens of camera module, so the effect is the same
as the human eye with a magnifying glass to observe. As the camera module can zoom range is much larger than
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EDAN INSTRUMENTS, INC.
the human eye It is not necessary to replace the magnifying glass to change the magnification, only need to
transform the camera module lens focal length you can get different magnification of the image.
The design of LED lighting module includes a selection of LED light-emitting diodes, arrangement of structural,
the LED and LED driver.
1. Through a fixed direction of the LED structure, making the beam focus on the place of irradiation 300mm
working distance away from the lens, fixed angle of the LED illumination focus.
2. LED color temperature of fluorescent color temperature
The control module functions for the LED driver, electronic camera control, key control and video signal
communication.
The capture module is composed of USB to COM, USB HUB and USB Video capture card.
The HD capture module is composed of USB to COM, HDMI HUB, USB HUB and USB Video capture card.
The video colposcope software systems includes image display, patient information management, print the report
and so on. The real-time images of the patient through the Video signal transmission to the computer, Workstation
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via video capture cards, analog signal conversion to digital signals through the display image.
2.4 Marketing History
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The feedback from customers and health care professionals shows that the device satisfies the requirements of
safety and effectiveness. There were no recalls or other regulatory actions or adverse events reported for the
device in any of the country it has been sold.
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2.5 Planned Change of the Product
1.Annually update some CE files according to the current video colposcope system.
2. The video colposcope software was updated to V1.57：The patient information interface is optimized, and the
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patient information and colposcopy indications are combined in the same interface; the font of drawing prompt is
increased in the observation and examination interface; ASCCP terms are added in the examination and analysis.
2.6 Classification of Video Colposcope
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According to the intended use of C3A/C6A/ C6A HD and the rules on medical devices Annex IX Rule 1 attached
to Directive 93/42/EEC of Directors Board of EEC, they are Class I medical device(Power Adaptor:
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ME20A1202F01).
Classification of Accessories
According to the intended purpose of the accessories, and the rules on medical devices classification in Annex IX
of MDD93/42/EEC, the accessories are not medical device.
2.7 Conformity Assessment Route
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Video colposcope(C6A HD& C6A&C3A) is Class I medical device, the conformity assessment route we choose
is Annex VII.
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