This manual in English is the original version.
Due to the constant engagement of Gendex to the
technical improvement of its products, all data and
information in this Operator’s Manual are subject to
change without prior notice.
8.1 Installation of the software for diagnostic imaging ......................................................................29
8.2 Data cable connection Computer(s) Panoramic System .............................................................29
8.3 Installation of the ActiveX driver ..........................................................................................................29
8.4 Status icon ....................................................................................................................................................30
9
Preparation 31
9.1 Switching on the system .........................................................................................................................31
9.2 Coupling/releasing of the sensor module ........................................................................................31
9.3 Setting the primary collimator ..............................................................................................................34
9.4 Selection of the projection .....................................................................................................................35
9.5 Selection of the patient size ...................................................................................................................35
9.6 Setting the technical parameters .........................................................................................................36
9.7 Use of the AEC (Automatic Exposure Control) in panoramic mode ........................................36
9.8 Performing a “dummy run” ......................................................................................................................37
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Gendex Orthoralix® 9200 DDE
10
11
12
Standard panoramicprogram 39
10.1 Setting the standard panoramic programme ..................................................................................39
10.2.1 Use of the bite block / chin rest ............................................................................................40
10.2.2 Placing the patient in the system ......................................................................................... 40
10.3 Vertical movement of the column ...................................................................................................... 41
10.4 Use of the positioning lasers .................................................................................................................. 42
14.1 Description of the Ceph arm ..................................................................................................................61
14.2 Description of the Ceph keyboard .......................................................................................................62
14.3 Description of the primary collimator ................................................................................................63
Preparation of the system 65
15.5 Inserting the Ceph CCD sensor ............................................................................................................65
15.2 Setting the collimator in the tubehead assembly .......................................................................... 67
15.3 Selection of the projection .....................................................................................................................68
15.4 Selection of the patient size ................................................................................................................... 69
15.5 Setting the technical parameters ......................................................................................................... 69
15.6 Use of the AEC (Automatic Exposure Control) in cephalometric mode ................................. 70
15.7 Performing a “dummy run” ......................................................................................................................71
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Gendex Orthoralix® 9200 DDE
16
17
18
19
Latero-lateral projection 73
16.1 Patient positioning in latero-lateral radiography ........................................................................... 73
16.1.1 Positioning the Cephalostat ................................................................................................... 73
16.2 Placing the patient in the system ......................................................................................................... 75
19.1 Preparing the system ................................................................................................................................ 87
19.1.1 Setting the collimator ............................................................................................................... 87
19.1.2 Placing the carpus positioner ................................................................................................ 88
19.2 Placing the patient in the system ......................................................................................................... 89
20.6.1 Use of the impression tray ...................................................................................................106
20.6.2 Use of the special TRANSCAN bite block ........................................................................106
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Gendex Orthoralix® 9200 DDE
21
22
23
24
25
A
B
C
Use of the special TMJCephalostat 109
Use of the technicaltest phantom 111
Hygienic proceduresand cleaning 113
User programs 115
Messages and alarms 117
Appendix A : Technical data 119
Appendix B : Technical factors 121
Appendix C : X-ray projections geometry 123
Gendex® and Orthoralix® are Registered Trademarks of GENDEX Corporation.
VixWinTM is Trademark of GENDEX Corporation.
Microsoft®, Windows®, Windows98®, WindowsME®, Windows2000®, WindowsXP®,
are Registered Trademarks of Microsoft Corp.
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6
Introduction
The Gendex Orthoralix 9200 DDE is a system for X-ray images acquisition in real time and by a
computer. It allows to realize all the radiographic projections which are of greater interest for
dentist, surgeon and maxillo-facial radiologist.
A new CCD sensor (Charge Coupled Device) makes possible the image acquisition in real time
and with the best diagnostic quality.
Gendex Vixwin software creates a simple interface giving immediate access to diff erent
functions: capture, vision, analysis and eventual treatment of the radiographic images.
The system for patient positioning is provided with an effi cient optical centering system
(with three lasers) and with a full motorized ultrasensitive moving system; it ensures a careful
positioning of the patient.
A friendly control panel with functional keys (it has a simple use and an easy access)
is controlled by a microprocessor and shows the used technical factors (kV, mA, s) and
positioning data (mm) in order to make easy the reproducibility of the tests.
1
Near the control panel, on the right side of the column, there is a reference pictographic
guide: it indicates the options/actions necessary to perform a Standard Panoramic Exposure.
1.1 Graphic methods
Three graphic methods are used in this manual:
Normal For information about the machine employment.
This icon indicates the notes.
This icon indicates the security warnings.
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Gendex Orthoralix® 9200 DDE
This manual is intended to assist the user in the safe and effi cient operation of the
equipment described. The equipment must be used in accordance with the procedures
contained in the manual and must not be used for purposes other than those which are
described herein.
The equipment should only be used by persons having recognized qualifi cations and, if
relevant, having adequate training on the particular equipment, especially regarding
protective measures such as radiation protection.
It is the responsibility of the user to ensure that existing legal regulations regarding
installation of the equipment are observed. Moreover, the legal regulations regarding
operation of the equipment must be observed.
Incorrect operation or failure of the user to maintain the equipment in accordance
with the maintenance schedule, relieves the manufacturer or his agent from all the
responsibilities for consequent non-compliance, damage, injury, defect and/or other
malfunction.
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Gendex Orthoralix® 9200 DDE
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Gendex Orthoralix® 9200 DDE
Safety procedures
Aims
• Indicating standards and safety regulations
• Observing the main safety procedures in the interest of patient and user
Contents
• Introduction
General description of the Orthoralix 9200 DDE system.
• Standards and Regulations
Regulations and standards, which Orthoralix 9200 DDE is in compliance with.
• Safety procedures
Instructions to observe in the interest of patient and user.
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Standards and Regulations
Orthoralix 9200 DDE unit is designed to meet the following standards:
• IEC 60601-1 (1988) (amendament 1991 and 1995)
• IEC 60601-1-4 (1996) (amendament 1999)
• IEC 60601-2-7 (1998)
• IEC 60601-2-28 (1993)
• CSA-C22.2 n. 114
• UL 187
Radiation protection:
• IEC 60601-1-3 (1994)
Electro-magnetic interference:
2
• IEC 60601-1-2 Ed. 2 2001-09
Lasers:
• IEC 60825-1 (2001)
0051 The CE symbol ensures that the product herein described meets the provisions of
European Council Directive 93/42 concerning medical devices.
Gendex Dental System, Cusano Milanino Italy, is the manufacturer and dealer in accordance
with European Council Directive for medical devices 93/42/CEE.
Classifi cation
Orthoralix 9200 DDE is a Class I and Type B electromedical X-ray equipment according to IEC
60601-1.
Orthoralix 9200 DDE is classifi ed in class IIB according to the European Council Directive for
medical devices 93/42/CEE.
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Gendex Orthoralix® 9200 DDE
Explanation of symbols
The following symbols are used in the equipment and/or in this manual:
Equipment classifi ed as Type B by IEC 60601.1
Consult written instructions in this Operator’s Manual.
General X-ray radiation warning
General laser radiation warning
Warning in this Operator’s Manual
Notes in this Operator’s Manual
Beware of moving mechanical parts.
Mandatory reporting according to the European Directive for 93/42 medical devices:
In order to fulfi l the obligations foreseen by the CE marking, the user is obliged to report any
accident involving the medical device; any alterations to its features or in its performance
– including insuffi cient user’s instructions – which could cause death, injuries or health
hazards to patient and/or operator, to the competent Health Authorities. Such reporting must
also be promptly notifi ed to the manufacturer or his agent, in order to permit the fulfi llment
of the obligations foreseen for said manufacturer in the a.m. European Directive.
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12
Safety Procedures
In the interest of the safety of patient and user, the following points should
be observed:
General
The equipment must never be used if it shows any electrical, mechanical or
radiation defects whatsoever. As all electromedical devices, Orthoralix 9200
DDE requires correct installation, handling, maintenance and servicing in
order to ensure safe and effi cient operation. The unit features continuos
operation (stand-by) with intermittent loading (X-rays).
Refer to the Service Manual for the recommended programmed
maintenance activities. Modifi cations and additions to the equipment
must be carried out only by Gendex personnel or third parties that are
expressly authorized by Gendex, and must comply with the applicable legal
requirements as well as with the generally accepted technical regulations.
3
The tubehead contains mineral insulating oil. Such oil is potentially harmful
in case of ingestion or contact with skin or mucosa. In case of a defect or
fault, an oil leak can occur. Avoid direct contact with the oil and do not
inhale its vapors.
In case of minor leaks, the oil can be wiped away with a dry cloth, wearing
protective gloves.
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Gendex Orthoralix® 9200 DDE
Radiation protection
Orthoralix 9200 DDE implements various built-in measures to prevent
excess radiation (leakage, secondary and scattered) from reaching the
patient, the operator, and other persons.
It is the responsibility of the qualifi ed Radiation Protection Inspector to
ensure that the proper measures are taken to prevent undue radiation
exposure to personnel and to the public at large.
All personnel in the examination room must exercise radiation safety
procedures.
To protect the patient against unnecessary radiation, other accessories
can be used whenever necessary, in addition to those provided on the
Orthoralix 9200 DDE (for example, fi lters).
Care must be taken, however, that these accessories do not interfere with
the proper radiographic operation of the apparatus.
For instance, lead shield collars should be avoided as they may block the
useful X-ray beam.
The following points must be always be observed:
Maintain a safety distance of at least 2m from the X-ray tube during
exposure;
All persons not directly involved with the patient should be outside the
examination room, or behind lead or leadglass shielding, during exposure;
A fi lm badge should be carried for personal monitoring.
Electrical safety
Only qualifi ed service personnel should be authorized to remove the covers
of, or otherwise obtain access to, parts of the equipment that include line
voltage powered circuits, included the provision for an additional security
earth terminal which permits an equipotential connection.
The equipment may only be used in rooms which comply with the relevant
national and/or international legislation and recommendations (e.g. CE and
others) concerning electrical safety in rooms used for medical purposes.
Always disconnect or switch off the equipment before cleaning or
disinfecting.
No water or any other liquid should be allowed to enter the equipment, as
they could cause short-circuits and corrosion.
Mechanical Safety
Due care must be taken when the system is used to ensure that neither patient
nor personnel reach into the equipment or get their clothing caught in it.
The equipment contains mechanical components such as cables, rubber
belts and gears, which are subject to operational wear and tear.
To prevent any risk of injury to patient and operator due to components
which no longer comply to normal safety standards (e.g. worn cables
subject to movement), the equipment must be subject to regular technical
testing and maintenance.
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Gendex Orthoralix® 9200 DDE
Explosion Safety
This equipment is not suitable for use in the presence of fl ammable gases
or vapors. Certain disinfectants vaporize and form explosive mixtures. If
such disinfectants are used, the vapors must be left to disperse before the
equipment is powered-up again.
Positioning safety
During Panoramic procedures, the patient is positioned facing the
positioning mirror in front of him. On reset position, the DMU will be at his
right and the tubehead at his left.
Once the exposure has been performed, positioning references (L and R)
will be displayed on the acquired image:
• L (Left) to indicate the left side of the patient’s mouth,
• R (Right) to indicate the right side of the patient’s mouth.
On symmetrical images both L and R are displayed, on half-exposure images
only one letter (L or R), indicating the side of the mouth, will be displayed.
No letter is placed in correspondence of the centre of the mouth.
It’s strongly recommended to pay attention to the L and R letters to identify
the anatomical side and to avoid any mistake during the its evaluation.
During Cephalometric symmetrical projections, neither L nor R is displayed
on the image, due to the impossibility for the system to detect if the
patient is placed in Antero-Posterior or Postero-Anterior position. It’s user
responsibility to pay attention to the anatomical side.
Laser Safety
This equipment is designed in accordance with IEC 60825-1:2001.
The position of laser sources are emphasised by mean of the following
warning labels (black on yellow).
Although compliant to the safety rules, it is a good practice for the operator
to avoid to expose his eyes and patient’s eyes directly to the LASER beam.
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Gendex Orthoralix® 9200 DDE
Location of lasers apertures:
Two lasers for the lighting of the mid-sagittal plane (vertical laser beam) and the lighting of
the Frankfurt plane (horizontal laser beam) are positioned behind the mirror.
The laser for the lighting of the roots of the lateral incisors (vertical lateral laser beam) is
positioned on the rotating arm, on the left of the sensor.
Use of controls or adjustments or performance of procedures other than
those specifi ed in this manual may result in hazardous radiation exposure.
Mid-saggital plane LASER
and Frankfurt plane LASER
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Vertical lateral LASER
Gendex Orthoralix® 9200 DDE
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Gendex Orthoralix® 9200 DDE
Characteristics and installation
Aims
• Indication of the functional characteristics of the panoramic radiography system.
• Correct installation and confi guration of the parts necessary for the regular
performance of Orthoralix 9200 DDE.
Contents
• General description
Main characteristics and programs of panoramic radiology available in the
Orthoralix 9200 DDE system.
• Preliminary procedures
Operations necessary for the correct confi guration of the external parts,
Personal Computer, in connection with Orthoralix 9200 DDE.
• Installation of driver and software
Instructions for installation, confi guration and examination of driver and
software necessary to obtain the digital radiographic image.
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Panoramic system
General Description
Orthoralix 9200 DDE is a system for panoramic radiography of the dento-maxillo-facial area.
4
B
A
C
The system is made by:
A A counter-balanced motorized column to be fi xed to wall, or to an optional free
standing base;
B A motorized carriage, with patient positioning system, technical factors and
radiographic projection geometry;
C An X-ray tubehead, with DC power supply to the X-ray tube via electronic converter;
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Gendex Orthoralix® 9200 DDE
System components:
1 Digital module unit (DMU)
2 DMU release buttons
3 X- ray tubehead
4 Primary collimator
5 Motorized head-rest
6 DMU housing
7 Bite block (can be replaced with the chin rest)
8 Handgrip
9 Positioning mirror
10 Frankfurt plane laser setting
11 Main keyboard
6
5
4
3
2
7
8
9
11
10
1
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Exposure automatism
During a panoramic exposure, the X-ray tube and digital sensor are moving on a trajectory
around the patient head. The beam from the X-ray tube is collimated by a slit diaphragm.
All movements for the radiographic panoramic projection are performed by three
independent, microprocessor controlled stepper motors. Various projection geometries for
panoramic exposures and for diff erent diagnostic purposes are possible.
Patient positioning is simple, accurate and consistent thanks to the motorized headrest, the
motorized displacement of the X-ray generator assembly while the patient stands still, the
indication of the positioning data and various other available positioning devices.
Thanks to the robotized movement technology, various exposure modalities with diff erent
projection geometry can be executed.
The digital radiographic images are displayed by the monitor of a personal computer
connected with Orthoralix 9200 DDE.
For common panoramic radiography the Standard Pan modality should be selected. With this
projection program the entire dental and alveolar region as well as the rami and the TMJ can
be depicted.
5
In addition to the Standard Pan modality the following projections are available:
Available basic programs:
• Standard Panoramic
• Child Panoramic
• Orthogonal Dentition
• Half-panoramic
• Lateral TMJ
• Frontal dentition
Dento-Maxillo-facial projections programs:
• Frontal TMJ
• Frontal sinus
• Lateral sinus
• Half-orthogonal dentition
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Gendex Orthoralix® 9200 DDE
Control panel
Each keystroke is associated with one and only one function and operation: the operator,
therefore, does not use more than one key to initiate a given function. Where applicable, each
keystroke is confi rmed by an associated LED light and/or a buzzer. Each key is labeled with a
pictogram related to the performed function.
Cephalography mode
Transcan mode
The unit is in Panoramic mode
+kV Increase kV for the next exposure
--kV Decrease kV for the next exposure
+mA Increase mA for the next exposure
-mA Decrease mA for the next exposure
+s Increase exposure time (s) for the next
exposure (disabled)
-sDecrease exposure time (s) for the next
exposure (disabled)
Patient size indicator (small, medium, large)
Patient size selector
AEC AEC mode
Select the available projection modalities
Select the available projection modalities
Select the Standard Panoramic Program
Move backward the motorized X-ray carriage
Move forward the motorized X-ray carriage
Switch on the timed centering lasers
Close the headrest
Open the headrest
Reset position, moves the motorized X-ray carriage
into start position
Dummy run, execute a simulation of the selected
program by performing the movements without
X-ray emission
Move the X-ray carriage up
The equipment is ready for an X-ray emission
X-rays are being emitted
Move the X-ray carriage down
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22
5.1 AEC MODE
For a number of the panoramic projections it is possible to activate the Automatic Exposure
Control (AEC) mode.
AEC is a real-time control of the dosage necessary to obtain the correct exposure of the
radiography, varying the preimposed technical factors for the selected patient type (kV).
The AEC function uses the detector sensor to measure residual dosage during the scanning
and allows real time correction of technical factors in order to ensure optimum balance
between contrast and image blackening.
At the end of the exposure, and in case of any correction during the exposure time, the
operator can verify the maximum value reached by pressing either the kV+ (LED on) key in
case of an increment or the kV- (LED on) key in case of a reduction. The value will be indicated
on the control panel.
The correction limit of the “AEC” mode is set at +/- 6kV from the selected value.
In case the system will automatically disable the “AEC” mode (display of the “AEC
DISACTIVATED” message in the control panel), the system will use the preset values selected
for patient size.
Gendex Orthoralix® 9200 DDE
The possibility to manually change the technical factors for exposure is inhibited when the
AEC function is activated.
The AEC mode can be selected for the following projections:
• Standard panoramic
• Child Panoramic
• Orthogonal dentition
• Lateral TMJ
• Frontal sinus
• Ceph LL H
• Ceph LL MAX
• Ceph LL V
• Ceph AP/PA V
• Ceph AP/PA MAX
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Gendex Orthoralix® 9200 DDE
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24
Recovery of images
In case of PC crash during an exposure, Orthoralix 9200 DDE gives the possibility to recover
the acquired image.
In this case simply restart the PC without switching off the Orthoralix.
Then restart the PC and from the tab in the OCX panel ask to “resend last image”.
This feature allows the user to avoid the administration of any useless additional dose to the
patient, increasing in this way the high level of safety of the Orthoralix system.
6
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Gendex Orthoralix® 9200 DDE
Operator’s Manual 4519 986 09042 - October 2005
26
Preliminary procedures
Before positioning the patient and executing radiographic exposure some preliminary
operations may be necessary.
In particular, it is important to confi gure a correct combination between Orthoralix 9200 DDE
and Personal Computer.
Therefore, the other electrically connected parts (Computer and optional peripherals) shall
be located outside from the patient area, and should be in conformity with IEC 950 and CE
89/336 Directive.
7.1 Peculiarities of Personal Computer
• Processor: Pentium III or higher (500MHz min).
• 256 MB RAM recommended.
• Video card/graphic controller for Super-VGA 4 MB mode RAM screen.
• Ethernet card 10/100 base T.
• CD-ROM driver.
• Hard disk.
• Keyboard, mouse.
• Multisync colored monitor with high resolution: 800x600 min. or 1024x768
• Operating system: Microsoft Windows 98, Windows 2000, Windows ME, Windows XP.
7
Video card
For a correct radiographic image a video mode with at least 1024x768 pixels x 16Millions
of colors (24bit, True color) should be chosen, the related scale has 256 gray-levels (If a
mode with 15 or 16 bit is chosen, the gray-levels are 32).
For the S-VGA 1024x728 mode it is necessary to have a video card with 4 MB RAM, the
installation and the use of the software provided with the installed video card or those
available in Microsoft Windows.
Monitor
To ensure a correct view of the images, it is recommended a multisync colored monitor.
This monitor can give a resolution in S-VGA mode of 640 x 480, 800 x 600 and 1024x768
pixels. Such resolution is related to the mode selected by the video card. A 15” or
17”screen is recommended, with dot-pitch not higher than 0.28 mm. Ensure to correctly
adjust contrast and brightness.
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Gendex Orthoralix® 9200 DDE
Hard disk
The choice of the hard disk depends on the number and dimension of images to store.
Hard disk with 8GB is usually able to satisfy user’s requirements.
However, for data security it is better to duplicate the stored information and diagnostic
images.
Back up (security copy in order to recover the lost data)
It is recommended to often duplicate image and-patient data (for instance weekly) on a
removable device for a general storage (e.g. removable hard disk, CD-Rom, etc.).You can
use the back-up functions provided in the Microsoft software, or copy data and images
directly on the removable storage device.
7.2 Application software
The Orthoralix 9200 DDE system is provided with the Gendex software VixWin.
VixWin is an application software program; it operates into Microsoft Windows for diagnostic
imaging in dento-maxillo-facial area.
Its main function is the control of capture, vision, eventual treatment
(*)
, analysis and storage of
radiographic dental images obtained by CCD sensors (Charge Coupled Device); in addition, it
supplies these functions for various other diagnostic images, for instance for those obtained
by radiographic fi lms (panoramic and others) and by a back-lit scanner, phosphor plates
obtained by Gendex DenOptix or colored images realized by an endoral or extraoral dental
camera (for example AcuCam Concept IV).
VixWin includes functions to store images in permanent storage devices, such as hard disks,
fl oppy disk, writable cd-rom, which are local or in common with other points of LAN (Local
Area Network).
The functionality is in accordance with the standard graphic interface of Microsoft Windows.
The functions can be selected by mouse and/or keyboard.
VixWin can be also interfaced by an external database software, for instance a program for
the global administration of the odontologic offi ce. This interface is based on a protocol DDE
client-server (DDE, Dynamic Data Exchange is a standard protocol of Microsoft Windows for
data-exchange among diff erent programs).
In this case, capture, vision, treatment and analysis of the images are performed within VixWin,
whereas the storage in database is controlled by the administration software.
(*) Among the image treatments available with VixWin, it is possible to measure the lengths (length
measures) on the obtained images; in particular, this treatment is useful for the panoramic images.
The length measuring gauge allows to calibrate the length of an object with known dimension. (Refer to
the paragraph about the calibration of length in Operator’s Manual VixWin).
Operator’s Manual 4519 986 09042 - October 2005
28
8
Installation
What is mentioned in this chapter is a quick overview of the steps to be followed during the
installation (installation of the imaging software, network connection, installation of the
driver). Please, refer to the Service manual for the complete installation procedure.
8.1 Installation of the software for diagnostic imaging
Install on the Personal Computer(s) that will be connected to the Orthoralix the application
software VixWin for diagnostic imaging (contained in the VixWin packing supplied with the
system), and follow the video instructions.
To have other information, refer to section 2 “Installation, confi guration and preferences” in
the Operator’s Manual VixWin.
8.2 Data cable connection Computer(s)
Panoramic System
After installing VixWin, plug the Orthoralix in the network where the PC(s) that will be
connected to the panoramic system are plugged.
In case of stand-alone modality, the PC and the Orthoralix DDE have to be connected through
a crossover network cable or by means of a standard cable plus hub between the computer
and the Panoramic System.
8.3 Installation of the ActiveX driver
When the Orthoralix DDE and the computer(s) are plugged in the network and the imaging
software VixWin is running on the PC(s), the connection PC(s)-Orthoralix DDE has to be
completed by running the ActiveX driver on the PC(s). To install the ActiveX driver, insert the
ActiveX CD-Rom and follow the CD instructions.
Notes for testing or installation of the software driver are contained in Microsoft
Windows Manual. If the user is unskilled, he must not install the software driver, but
apply to a trained personnel.
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29
Gendex Orthoralix® 9200 DDE
8.4 Status icon
In the System Tray of Windows (in “application bar” near the “system clock” available in all the
versions of the Microsoft Windows operating systems) there is one ICON, which represent
the operation of Orthoralix 9200 DDE and CCD sensor. The colours of the icon represents a
diff erent operation status.
The diff erent status and the related icons are indicated in the following list.
GREEN Icon: it indicates the correct operation of electronics, CCD sensor and connection.
Orthoralix 9200 DDE is ready to capture the images
Hardware faulty condition
DMU not present
Connection status
RED Icon: Orthoralix 9200 DDE is not able to acquire the images.
System not connected.
YELLOW Icon
The PC does not have the control, but is connected
DRIVER icon
Gendex products:
By clicking on this icon with right key of the mouse, a menu is displayed, in which it is possible
to view and to modify both data and parameters common to all the Dentsply Gendex imaging
system products (VisualiX, Concept, DenOptix).
If the status icon is not visible, verify the correct installation of the software driver.
Double click on the status icon allows to enter a confi guration panel which contains
information about the operation of electronics, the software version, and the
characteristics of sensor (that is a useful information to ask for the Technical Service).
Operator’s Manual 4519 986 09042 - October 2005
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