EDAN C3A User manual

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About this Manual
P/N: 01.54.456077
Version 2.1
MPN: 01.54.456077021
Release Date: July, 2019
© Copyright EDAN INSTRUMENTS, INC. 2013-2019. All rights reserved.
Statement
This manual will help you understand the operation and maintenance of the product better. It is
reminded that the product shall be used strictly complying with this manual. User's operation
failing to comply with this manual may result in malfunction or accident for which EDAN
INSTRUMENTS, INC. (hereinafter called EDAN) cannot be held liable.
EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any
materials contained in this manual shall not be photocopied, reproduced or translated intoother
languages.
Materials protected by the copyright law, including but not limited to confidential information
such as technical information and patent information are contained in this manual, the user shall
not disclose such information to any irrelevant third party.
The user shall understand that nothing in this manual grants him, expressly or implicitly, any
right or license to use any of the intellectual properties of EDAN.
EDAN holds the rights to modify, update, and ultimately explain this manual.
Responsibility of the Manufacturer
EDAN only considers itself responsible for any effect on safety, reliability and performance of
the equipment if:
Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by
persons authorized by EDAN, and
The electrical installation of the relevant room complies with national standards, and
The instrument is used in accordance with the instructions for use.
Terms Used in this Manual
This guide is designed to give key concepts on safety precautions.
WARNING
AWARNING label advises against certain actions or situations that could result in personal
injury or death.
CAUTION

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A CAUTIONlabel advises against actions or situations that could damage equipment, produce
inaccurate data, or invalidate a procedure.
NOTE
A NOTE provides useful information regarding a function or a procedure.

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Table of Contents
Chapter 1 Safety Guide.......................................................................................................... 1
1.1 Intended Use/Indications for Use ........................................................................................................1
1.2 Safety Precautions...............................................................................................................................1
1.3 Definitions and Symbols .....................................................................................................................4
Chapter 2 Introduction........................................................................................................... 8
2.1 System Connection..............................................................................................................................8
2.1.1 Computer Requirements......................................................................................................9
2.1.2 Monitor Requirements..........................................................................................................9
2.1.3 Printer Requirements ...........................................................................................................9
2.2 Camera...............................................................................................................................................10
2.2.1 Appearance.........................................................................................................................10
2.2.2 Keys......................................................................................................................................10
2.3 Vertical Stand.....................................................................................................................................12
2.4 SwingArm Stand...............................................................................................................................13
2.5 MT-806 Trolley..................................................................................................................................16
2.6 Fixed Video Capture Box ..................................................................................................................17
2.7 Movable Video Capture Box .............................................................................................................17
2.8 Foot Switch........................................................................................................................................18
2.9 PowerAdapter...................................................................................................................................18
Chapter 3 Basic Operations............................................................................................... 19
3.1 Opening and Checking the Package..................................................................................................19
3.2 Adjusting the Vertical Stand..............................................................................................................19
3.2.1 Placing/Moving the Stand..................................................................................................19
3.2.2Adjusting the Stand Height................................................................................................20
3.2.3Adjusting the CameraAngle..............................................................................................20
3.3 Adjusting the SwingArm Stand ........................................................................................................21
3.3.1 Placing/Moving the Stand..................................................................................................21
3.3.2Adjusting the Camera Stand Height.................................................................................22
3.3.3Adjusting the CameraAngle..............................................................................................23
3.3.4Adjusting the Position of Keyboard Tray or Laptop Tray...............................................24
3.3.5Adjusting the MonitorAngle...............................................................................................24
3.4 Adjusting the MT-806 Trolley...........................................................................................................24
3.4.1 Placing/MovingtheTrolley...................................................................................................24
3.4.2Adjusting the MonitorAngle...............................................................................................24
3.5 Connecting the PowerAdapter..........................................................................................................25
3.6 Switching on the System ...................................................................................................................25
3.7 Switching off the System...................................................................................................................25
Chapter 4 Software Installation......................................................................................... 26
Chapter 5 Application of the Video Colposcope Software ........................................ 32
5.1 Starting up the Software....................................................................................................................32
5.2 Main Interface ...................................................................................................................................33
5.3 Patient Information............................................................................................................................33
5.3.1 Adding a Patient..................................................................................................................33
5.3.2 Viewing Today's Exam Schedule......................................................................................36
5.3.3 Browsing Examination Record..........................................................................................37
5.3.4 Modifying Patient Information............................................................................................37
5.3.5 Deleting Patient Information..............................................................................................38
5.3.6 Searching for a Re-examined Patient..............................................................................38
5.3.7 Making an Appointment .....................................................................................................39
5.3.8 Searching for an Appointment...........................................................................................40
5.3.9 Modifying an Appointment.................................................................................................40
5.3.10 Deleting an Appointment .................................................................................................40

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5.3.11 Follow-up Management...................................................................................................40
5.3.12 Bar Code Scanner Function............................................................................................41
5.3.13 Patient Info. Input Items Customization.........................................................................42
5.3.14 Worklist...............................................................................................................................42
5.4 Examining..........................................................................................................................................43
5.4.1 Examination Prompts.........................................................................................................43
5.4.2 Capturing Images................................................................................................................43
5.4.3 Taking Video........................................................................................................................45
5.4.4 Viewing in FullScreen Mode..............................................................................................45
5.4.5 Making Comparison............................................................................................................46
5.4.6 Analyzing..............................................................................................................................47
5.4.7 Comparing Images .............................................................................................................47
5.4.8 Editing an Image.................................................................................................................47
5.4.9 Measuringan Image............................................................................................................49
5.4.10 Import Image.....................................................................................................................50
5.5 Analyzing...........................................................................................................................................51
5.5.1 Comparing Images of the Current Patient ......................................................................51
5.5.2 Making Comparison with an Existing Case.....................................................................54
5.5.3 Performing R-way Evaluation............................................................................................54
5.5.4 Inputting Examination Result ............................................................................................55
5.5.5 Inputting Biopsy Result......................................................................................................58
5.5.6 Performing RCI Evaluation................................................................................................59
5.5.7 Performing Swede Evaluation...........................................................................................62
5.5.8 SavingAnalysis Result.......................................................................................................62
5.6 Examination Report...........................................................................................................................63
5.6.1 Printing the Examination Report.......................................................................................63
5.6.2 Changing Print Settings.....................................................................................................64
5.6.3 Selecting a Print Template.................................................................................................65
5.6.4 Exporting the Report...........................................................................................................65
5.6.5 Sending the Report to PACS.............................................................................................66
5.6.6 Emailing the Report............................................................................................................66
5.7 Report................................................................................................................................................66
5.8 Operation Record...............................................................................................................................67
5.8.1 Printing the Operation Report...........................................................................................68
5.8.2 Specifying the Record........................................................................................................68
5.8.3 Changing Print Settings.....................................................................................................69
5.8.4 Selecting a Print Template.................................................................................................69
5.8.5 Emailing the Report............................................................................................................69
5.9 History Case Database.......................................................................................................................69
5.9.1 Marking Attention Labels ...................................................................................................70
5.9.2 Searching for a History Case............................................................................................72
5.9.3 Browsing Examination Record..........................................................................................72
5.9.4 Browsing Patient Report....................................................................................................72
5.9.5 Modifying Patient Information............................................................................................72
5.9.6 Modifying Examination Record.........................................................................................72
5.9.7 Modifying Operation Record..............................................................................................73
5.9.8 Modifying Patient Report ...................................................................................................73
5.9.9 Inputting Pathology Result.................................................................................................73
5.9.10 Deleting Patient Information............................................................................................74
5.9.11 ExportingPatient Data......................................................................................................74
5.9.12 Importing Patient Data.....................................................................................................74
5.10 Statistics...........................................................................................................................................74
5.10.1 Performing Statistics........................................................................................................74
5.10.2 Exporting Patient List.......................................................................................................76
5.10.3 Exporting Chart.................................................................................................................77
5.11 Switching User ................................................................................................................................77
5.12 System Setup ...................................................................................................................................77

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5.12.1 User Management Setup.................................................................................................77
5.12.1.1 Setting Hospital Information..................................................................................77
5.12.1.2Adding a User..........................................................................................................78
5.12.1.3 Modifying User Information...................................................................................78
5.12.1.4 Deleting a User.......................................................................................................79
5.12.2 General Setup...................................................................................................................79
5.12.2.1 Changing Date Format..........................................................................................79
5.12.2.2 Setting Follow-up Period.......................................................................................79
5.12.2.3 Setting the Foot Switch..........................................................................................80
5.12.2.4 Setting the Camera Handle Trigger.....................................................................80
5.12.2.5 Setting the Video Capture Card...........................................................................80
5.12.2.6 Customizing the Database Header......................................................................81
5.12.2.7 Enabling the Report Export Function ..................................................................81
5.12.2.8 Enabling Sending Report to PACS......................................................................81
5.12.2.9 Enabling Automatic Running on Startup.............................................................82
5.12.2.10 Enabling PatientAppointment............................................................................82
5.12.2.11 Enabling R-way Evaluation.................................................................................82
5.12.2.12 Switching Positions of R-way Evaluation and RCI Evaluation......................83
5.12.2.13 Enabling RCI Evaluation.....................................................................................83
5.12.2.14 Enabling Swede Evaluation................................................................................83
5.12.2.15 Enabling Examination Prompts..........................................................................83
5.12.2.16 Enabling Auto Capture.........................................................................................84
5.12.2.17 Setting Capture Mode..........................................................................................84
5.12.2.18 Restoring to Factory Configuration....................................................................84
5.12.2.19 Setting Bar Code Scanner..................................................................................84
5.12.2.20 Module Customization.........................................................................................85
5.12.3 Database Management ...................................................................................................85
5.12.3.1 Backing up Database.............................................................................................85
5.12.3.2 Restoring Database...............................................................................................86
5.12.3.3 Exporting Terms......................................................................................................86
5.12.3.4 Importing Terms......................................................................................................86
5.12.4 Network Setup...................................................................................................................87
5.12.4.1 Enabling DICOM.....................................................................................................87
5.12.4.2 Enabling the Email Function.................................................................................87
5.13 Exit ..................................................................................................................................................88
Chapter 6 Maintenance and Cleaning.............................................................................. 89
6.1 Inspection ..........................................................................................................................................89
6.2 Daily Maintenance.............................................................................................................................89
6.3 Cleaning.............................................................................................................................................90
6.4 Disinfection .......................................................................................................................................90
Chapter 7 Warranty and Service....................................................................................... 92
7.1 Warranty ............................................................................................................................................92
7.2 Contact information...........................................................................................................................92
Appendix 1 Product Specifications.................................................................................. 93
A1.1 Environmental Specifications.........................................................................................................93
A1.2 Physical Specifications...................................................................................................................93
A1.3 Performance Specifications ............................................................................................................94
Appendix 2 Troubleshooting ............................................................................................. 96
A2.1 NoAccess to Video Colposcope Software and Error Reporting.....................................................96
A2.2 Access to Video Colposcope Software with Error Reporting.........................................................96
A2.3Trouble with Image Display............................................................................................................98
A2.4 Trouble with the Camera ................................................................................................................99
A2.5 Trouble with the Foot Switch .........................................................................................................99
Appendix 3Ordering Information.................................................................................... 100

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Appendix 4 EMC Information........................................................................................... 101
A4.1 Electromagnetic Emissions...........................................................................................................101
A4.2 Electromagnetic Immunity ...........................................................................................................102
A4.3 Electromagnetic Immunity ...........................................................................................................104
A4.4 Recommended Separation Distances............................................................................................107
Appendix 5 Abbreviation................................................................................................... 109

C3A, C6A, C6AHD Video Colposcope User Manual Safety Guide
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Chapter 1 Safety Guide
CAUTION
Federal (U.S.) Law restricts this device to sale by or on the order of a physician.
NOTE:
1 To ensure proper running of the device and safety of the operator and patient, read
through this chapter before using the device.
2 This user manual is written to cover the maximum configuration. Therefore, your
model may not have some of the parameters and functions described, depending on
what you have ordered.
1.1 Intended Use/Indications for Use
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, and not intended for home use or to
touch the patient.
1.2 Safety Precautions
WARNING and CAUTION messages must be observed. To avoid the possibility of injury,
observe the following precautions during the operation of the device.
WARNING
1 This device is provided for the use of professionally trainedandqualified physicians,
or under guidanceof these personnel. Familiarize yourself with the contents of this
user manual before operation.
2 Do not use the device in the presence of flammable anesthetics due to explosion risk.
3 SHOCK HAZARD–Do not attempt to connect or disconnect a power cord with wet
hands. Make sure that your hands are clean and dry before touching a power cord.
4 Electromagnetic Interference –Ensure that the environment in which the device is
installed is not subject to any source of strong electromagnetic emissions, such as CT,
radio transmitters, mobile phone base stations, etc.
5 Electromagnetic Interference –Do not use mobile phones nearby the device,
otherwise it may interfere with device operation.
6 Do not touch the signal input or output connector and the patient simultaneously.

C3A, C6A, C6AHD Video Colposcope User Manual Safety Guide
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WARNING
7 Accessory equipment connected to the device must be certified according to the
respective IEC/EN standards (e.g. IEC/EN 60950 for data processing equipment and
IEC/EN 60601-1 for medical equipment). Furthermore all configurations shall comply
with the valid version of the system standard IEC/EN 60601-1. If any question, please
consult our technical service department or your local distributor.
8 Connecting any accessory or equipment to the device makes a medical system. In
that case, additional safety measures should be taken during installation of the
system, and the system shall provide:
a) Within the patient environment, a level of safety comparable to that provided by
medical electrical equipment complying with IEC/EN 60601-1, and
b) Outside the patient environment, the level of safety appropriate for non-medical
electrical equipment complying with other IEC or ISO safety standards.
9 For any non-medical electrical equipmentforming part of the system to be used within
the patient environment, additional protective earthing should be applied or the
non-medical electrical equipment should be supplied via a separating transformer
that complies with IEC/EN 60601-1. If no separating transformer or other protective
measure is applied, the non-medical electrical equipment must be used outside the
patient environment, and the system should be tested according to the requirements
of IEC/EN 60601-1.
10 Do not exceed the maximum permitted load when using multiple portable
socket-outlets to supply the system. You can refer to the label or silk-screen for the
maximum permitted load.
11 SHOCK HAZARD –Do not connect non-medical electrical equipment, which has
been supplied as a part of the system, directly to the wall outlet when the
non-medical equipment is intended to be supplied via a multiple portable
socket-outlet with a separating transformer.
12 SHOCK HAZARD –Do not connect electrical equipment, which has not been
supplied as a part of the system, to the multiple portable socket-outlet supplying the
system.
13 Multiple portable socket-outlets shall not be placed on the floor. An additional multiple
portable socket-outlet or extension cord shall not be connected to the system.
14 Only accessories supplied by the manufacturer can be used.
15 Do not connect any equipment or accessories that are not approved by the
manufacturer or that are not IEC/EN 60601-1 approved to the device. The operation
or use of non-approved equipment or accessories with the device is not tested or
supported, and device operation and safety are not guaranteed.
16 Using accessories other than those specified by the manufacturer may result in
increased electromagnetic emissions or decreased electromagnetic immunity of the
device.
17 Make sure that all the components and accessories are connected correctly and
checked before powering on.

C3A, C6A, C6AHD Video Colposcope User Manual Safety Guide
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WARNING
18 No part of the device is intended to be maintained by the user. Unauthorized
servicemen shall not open the enclosure. Otherwise, safety hazards may happen.
19 The camera light source is very bright. When the camera is on, do not stare at the
light source or aim the light source at the patient's eyes.
20 The system is not for diagnosis or treatment, and it is a non-contact examination
device. It should not touch the patient during examination.
21 The mains plug is used as isolation means from supply mains. Position the device in
a location where the operator can easily access the disconnection device.
22 The device should not be used adjacent to or stacked with other equipment and that
if adjacent or stacked use is necessary, the device should be observed to verify
normal operation in the configuration in which it will be used.
23 The medical electrical equipment needs to be installed and put into service according
to the EMC Information provided in this user manual.
24 Portable and mobile RF communications equipment can affect medical electrical
equipment, refer to section A4.4 Recommended Separation Distances.
25 Do not service or maintain the device or any accessory which is in use with a patient.
26 Assembly of the device and modifications during actual service life shall be evaluated
based on the requirements of IEC60601-1.
CAUTION
1 The device is designed for continuous operation. Do not water the device.
2 Keep the environment clean. Makethe device far from corrosive medicine, dust area,
high-temperature and humid environment.Avoid vibration. Do not move it with the
power cord connected.
3 Do not operate the device if it is damp or wet because of condensation or spills. Avoid
using the device immediately after moving it from a cold environment to a warm,
humid location.
4 Do not sterilize the device or any accessory with autoclave or gas.
5 Do not plug any undefended USB device into the computer in which the video
colposcope software has been installed. Make sure that the connected USB device
is free of viruses.
6 If the computer in which the video colposcope software has been installed will be
connected to the network, install genuine antivirus software to protect the computer
against viruses.
7 Do not change the time of the system unless necessary, otherwise the appointment
data may be lost.
8 The device and accessories are to be disposed of according to local regulations after
their useful lives. Alternatively, they can be returned to the dealer or the manufacturer
for recycling or proper disposal.