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Gendex
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VisualiX
Maintenance manual
37 pgs502.53 Kb0
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Gendex VisualiX Maintenance manual

VisualiX® 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
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

1
2 3
4
5
6
7
Gendex VisualiXTM eHD
2
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
10 11
3

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.
1
Gendex VisualiXTM eHD
4
5

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 ap­plications 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ca­tions 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.
2
Gendex VisualiXTM eHD
6
Explosion safety:
This device is not recommended for use in the presence of ammable gases or va­pours. 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.
7

Standards and regulations

3.1 Compliance with regulations

The VisualiX system complies with the European Community Directive 93/42/EEC re­garding 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 ac­cordance 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.
3
Gendex VisualiXTM eHD
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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 Direc­tive 93/42/EEC for Medical Devices.
This symbol guarantees the confor­mity 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
SN
9

Product description

VisualiX is a direct (lmless) digital X-ray imaging system, conceived specically for dental radiography in the oral cavity. The system captures X-ray images and makes them available for display on a Personal Computer (PC) screen.
An X-ray image sensor (CCD) is positioned in the patient’s mouth just like intra-oral lm. The sensor may be inserted in a special positioning device to facilitate positioning and alignment with the X-ray beam. The sensor may also be positioned by hand with the assistance of the patient.
There is no electrical or physical connection between VisualiX and the X-ray generator. Images are automatically acquired when X-rays are present in a dose which is percep­tible to the sensor.
Digital X-ray images are quickly displayed on the screen. Images can be optimized for viewing via imaging software, stored as image les, and printed out on a suitable printer if desired. VixWin is one example of a dedicated software that employs a number of utilities for optimizing viewing and printing of images.
VisualiX must be connected to a PC running on a Microsoft® Windows® operating system through the standard USB port (Universal Serial Bus). See the “System Conguration” paragraph for details.
eHD Technology
eHD is the acronym of “Ergonomics and High Denition”: the latest, unsurpassed tech­nology in real-time X-ray imaging, which allows enhanced analysis of radiographic details using a highly ergonomic system characterised by round corners to facilitate positioning in the oral cavity.
eHD sensors can be identied by the eHD logo shown below which appears on the top of the sensor and Intermediate Electronics (IME) box.
4
Gendex VisualiXTM eHD
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Gendex VisualiXTM eHD
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4.1 Unpacking the VisualiX system components

The Visualix system is carefully inspected and packaged prior to shipment. If the Visualix system was shipped to you, please remove the contents of the shipping container and be sure to identify and directly locate each of the system components shown below.
Report any damaged components to the shipping company and any missing components to your dealer within 24 hours of receiving the shipment.

4.2 System Components

1) X-ray image sensor
consisting of a special CCD sensor specically constructed for use in radiography,
enclosed in a hermetically sealed ergonomic capsule, the sensitive surface of which is covered by a thin layer of a scintillator through which X-ray radiation is converted into light and then into an electric charge.
The sensor type reference part number appears on the IME label, see paragraph 3.2
Sensor Large area (Size 2)
Sensor Universal size (Size 1)
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