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EDAN Agile PLM Electronic Signature Information

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EDAN Agile PLM Electronic Signature Information

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EDAN Agile PLM Electronic Signature Information

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quimicos.mg061959

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EDAN Agile PLM Electronic Signature Information

--Signatures related to this document and performed in EDAN Agile PLM.

文件名称(Document Name)：C6 HD&C6&C3- TF17-Control of


Manufacturing Process
文件编号(Number)：EDAN-MDD-2212A-D0032
版本(Version)：1.5
产品型号(Product Model)：C3;C6 HD;C6
项目编码(Project Code)：2212A000

签批信息(Signature):
作者(Originator) : 吴 国杰 (wuguojie) 2019-01-02 19:01:58
审核人(Reviewers) : 杨 洁 (yangjie) 2019-01-03 14:41:32
审核人(Reviewers) : 杜 建峰 (dujianfeng) 2019-01-03 11:00:36
批准人(Approvers) : 章 鸿 (zhanghong) 2019-01-16 18:19:29

版权©深圳市理邦精密仪器股份有限公司 (Copyright©Edan Instrument,Inc.)


EDAN INSTRUMENTS, INC.

C6 HD&C6&C3-TF17-Control of Manufacturing Process

1. Introduction of Device Master Record

1 Introduction of Device Master Record

The device master record of Video Colposcope includes the following documents:
Class CF-Configuration
Class FL-Files List
Class PL-Part List
Class QC-quality control
Class ST-Safe Test
Class TI- test instruct
Class 01-Theory of Operation
Class 02-Procedure Guide
Class 03-Software/Firmware Method
Class 04-PCB Fabrication
Class 05-Schematic
Class 06-Mechanical Part
Class 07-Assembly
Class 81-Specification
Class 82-Manual
Class 83-Software
Class 84-Firmware
Class 11-Label
These files are used to maintain the whole manufacturing process of our products.
The device master records are controlled by Document Control Center.

2. Description of Manufacturing Process

The manufacturing process is controlled based on the Work Instructions in the device master record.
Manufacturing Flow Chart is attached with the file. File No. of the Work Instructions are shown with the related
sub-process in the flow chart.

Product traceability is realized by record batch code or serial number of materials on product traceability form
during assembling of the product.

The final inspection must validate that all of the manufactured products satisfy the applicable requirements of EN
60601 and EN 1041.

Manufacturing Flow Chart is as follows.

QP36-M015-1.3 Page 1 of 2
EDAN INSTRUMENTS, INC.

Start

Mechanical parts From Outsourcing (capacitance, resistance,


PCB,connectors, electrical parts from
contractor contractor contractor IC, screen, module, mainboard)

electrical parts
from contractors Check Y Check Y
Check N
storage
Y N N

The contractor of PCBA Return to Return to supplier


Manufacturer

N
PCBA Machining Check

PCBA Pass? N Maintenance


debugging

Y
Semi product warehouse

Main unit assembly Y


Switch on test High Temperature ageing

N
Maintenance
Redo in Batch N
RePacking Ageing ok?

Replace IC? N
Y

N Main unit test


N Maintenance
Y Y
Batch OK?
N QC test

N Safety test
Storage
N
Y
Y
FQC packing test Packing Surface depurate

QP36-M015-1.3 Page 2 of 2

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