Gendex VisualiX eHD Fehlerbehebungshandbuch

VisualiX® eHD

User and Service Manual

Doc# 4519 986 19041 - April 2005

Gendex VisualiXTM eHD

User and Service Manual Doc #4519 986 19041 - April 2005

No part of this publication may be reproduced, transmitted,

transcribed or translated into any spoken or computer language

without prior written consent from Gendex Dental Systems.

The content of this manual is subject to modication without

prior notication.

Gendex VisualiXTM eHD 
1
User and Service Manual  Doc #4519 986 19041 - April 2005 
Introduction                                                                                                                   3
1.1  Conventions used in the manual............................................................................................ 3
Safety procedures                                                                                                       5
Standards and regulations                                                                                     7
3.1  Compliance with regulations .................................................................................................. 7
3.2  Symbols appearing on the Intermediate Electronics (IME) Control Unit plate...... 8
Product description                                                                                                   9
4.1  Unpacking the VisualiX system components...................................................................10
4.2  System Components.................................................................................................................10
System conguration                                                                                              13
5.1  Personal Computer requirements........................................................................................13
5.2  Application software.................................................................................................................15
5.3  Compatibility with radiographic generators....................................................................16
Installation                                                                                                                    17
6.1  Installation of ActiveX software driver ...............................................................................20
Use                                                                                                                                     21
7.1  Acquisition of radiographic images ....................................................................................21
7.2  Status Icon ....................................................................................................................................24
7.3  Portability......................................................................................................................................25
7.4  Hygiene..........................................................................................................................................25
Table of contents
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2
3
4
5
6
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Gendex VisualiXTM eHD 
2
User and Service Manual  Doc #4519 986 19041 - April 2005 
3
User and Service Manual  Doc #4519 986 19041 - April 2005 
VisualiXTM and VixWinTM are Trademarks of Gendex Corporation.
Microsoft®  and Windows®  are  registered  trademarks  of Microsoft® 
Corporation.
This manual in English is the original version.
8
9
Maintenance                                                                                                                27
Technical specications                                                                                         29
Diagnostics                                                                                                                   31
Appendix                                                                                                                       33
11.1  Printers ..........................................................................................................................................33
11.1.1  Thermal printers .........................................................................................................33
11.1.2  Laser and ink jet printers .........................................................................................33
11.1.3  Sublimation printers .................................................................................................33
11.2  Software ........................................................................................................................................34
11.3  Service............................................................................................................................................34
11.4  Components Code List for VisualiX......................................................................................34
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Gendex VisualiXTM eHD

User and Service Manual Doc #4519 986 19041 - April 2005

Introduction

This User Manual contains instructions for safe set-up, use and maintenance of the

Gendex Dental Systems VisualiX eHD system.

It also contains technical specications of the system and basic information on how

the system works.

Please read this manual carefully before starting to use the device, paying particular

attention to warnings, especially safety warnings.

1.1 Conventions used in the manual

This manual features three graphic styles:

Normal: for information which must be read carefully before using the VisualiX system

Detailed notes, identied with the symbol

Safety warnings, identied with the symbol

Gendex is committed to ongoing technical improvement of its products. The information

and gures contained in this User and Service Manual are subject to change without

prior notication.

Gendex VisualiXTM eHD

User and Service Manual Doc #4519 986 19041 - April 2005

Gendex VisualiXTM eHD

User and Service Manual Doc #4519 986 19041 - April 2005

Safety procedures

The device must be installed and used in accordance with the safety regulations and

instructions for use supplied in this User and Service Manual, for the purposes and ap-

plications for which it is intended.

Modications and/or additions to the device must be made exclusively by Gendex

personnel or by parties expressly authorized for the purpose by Gendex. Any modica-

tions or additions must always comply with standards and generally recognised rules

of good workmanship.

It is up to the user to ensure compliance with all local safety regulations in eect in the

place of installation.

Electrical safety:

The covers on the device may be removed only by qualied, authorised technical

personnel.

The product must be used only in rooms or areas which comply with all laws and

regulations applicable to electrical safety in medical premises, such as CEI standards

regarding use of an additional ground terminal for equipotential connections. This

device must always be disconnected from the power supply before cleaning or

disinfection.

Water and other liquids must not be permitted to penetrate inside the device, where

they could cause short circuit or corrosion. No protection is supplied against liquid

penetration.

The conformity with the IEC standard 601.1.1 and the validity of the CE mark apply

only if the computer is located out of the patient’s reach (at a distance of least 1.5 m

from the patient) and if the computer complies with the IEC 60950 standard.

Gendex VisualiXTM eHD

User and Service Manual Doc #4519 986 19041 - April 2005

Explosion safety:

This device is not recommended for use in the presence of ammable gases or va-

pours. Some disinfectants evaporate and form explosive or ammable mixtures. If

disinfectants of this kind are used, it is important to let the vapours disperse before

using the device again.

Gendex VisualiXTM eHD

User and Service Manual Doc #4519 986 19041 - April 2005

Standards and

regulations

3.1 Compliance with regulations

The VisualiX system complies with the European Community Directive 93/42/EEC re-

garding medical devices and with the following standards:

• IEC 601.1 (1988), Amendment Nr. 1 (1991), Amendment Nr. 2 (1995)

• IEC 601.1.1 (2000)

• IEC 601.1.2 (2001)

• IEC 601.1.4 (1996), Amendment Nr. 1 (1999)

To ensure compliance, other parts of the system which are electrically wired (computer

and any other optional peripheral devices) must be located out of patient’s reach (at a

distance of not less than 1.5 m from the patient) and comply with the UL/IEC/EN 60950

standard and EC directive 89/336.

In case other parts of the system are non medical devices, further considerations should

be done in accordance with IEC60601-1-1, under the responsibility of the installation

technician.

Compulsory declaration under European Directive 93/42 regarding Medical Devices: In ac-

cordance with the requirements of the CE mark, the user must notify the Ministry of Health of

any accidents involving the device and any alterations in the characteristics or performance

of the device, including inadequacy of the instructions provided, which could result in death

or damage to the health of the patient or user.

A copy of this notication must be promptly sent to the manufacturer or a representative

thereof to permit the manufacturer to comply with the requirements of the directive.

Gendex VisualiXTM eHD

User and Service Manual Doc #4519 986 19041 - April 2005

3.2 Symbols appearing on the Intermediate

Electronics (IME) Control Unit plate

The symbol CE guarantees the

conformity of the product described

herein to the European Union Direc-

tive 93/42/EEC for Medical Devices.

This symbol guarantees the confor-

mity of the product described herein

to the standard UL 60601-1

Please refer to the written

instructions of this manual.

Class II device

(IEC 601.1 - 1988 and Amendments)

BF type device

(IEC 601.1 - 1988 and Amendments)

DC Current

(IEC 601.1 - 1988 and Amendments)

System serial number and sensor

type reference part number

0051

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