Gendex ORTHORALIX 9200 DDE User manual

Panoramic X-ray
Gendex Dental Systems
901 West Oakton Street
Des Plaines, IL 60018 U.S.A.
Tel [phone]
Fax [phone]
www.gendex.com
Authorized Representative:
KaVo Dental GmbH
Bismarckring 39
88400 Biberach, Germany
www.gendex-dental.com
www.kavo.com
User Manual
Installation Manual
Gendex Dental Systems
901 West Oakton Street
Des Plaines, IL 60018 U.S.A.
Customer Service 1-888-275-5286
Fax [phone]
Technical Support 1-888-275-5286
Fax [phone]
www.gendex.com
9200 DDE/Plus/Ceph

IMPORTANT! . . . X-RAY PROTECTION
X-ray equipment may cause injury if used improperly. The instructions
contained in this manual must be read and followed when installing, servicing,
or operating the Orthoralix® 9200 DDE. The Orthoralix 9200 DDE provides a
high degree of protection from unnecessary X-radiation. However, no practical
design can provide complete protection, nor prevent operators from exposing
themselves or others to unnecessary radiation. It is important that you become
fully acquainted with applicable government radiation protection regulations.
Many provisions of these regulations are based on the recommendations of
the National Council on Radiation Protection and Measurements.
Recommendations for dental X-ray protection are published in NCRP Report
Number 35 available from NCRP Publications, 7910 Woodmont Ave., Suite
800, Bethesda, MD 20814, or at www.ncrp.com. Personal radiation monitoring
and protective devices are available. You are urged to use them to protect
against unnecessary X-radiation exposure.

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Chapter 1 - About this Manual
Intended Use ................................................................................. 1-2
Conventions Used in this Manual ................................................... 1-2
Trademarks Used in this Manual .................................................... 1-3
Chapter 2 - System Description
Major Components ........................................................................ 2-2
Labels - Location and Descriptions ............................................... 2-6
Accessories ................................................................................... 2-9
Chapter 3 - Safety
Radiation Protection ...................................................................... 3-1
Electrical Safety ............................................................................. 3-2
Mechanical Safety ......................................................................... 3-2
Explosion Safety ............................................................................ 3-2
Laser Radiation Safety ................................................................... 3-2
Anatomical Reference Indications .................................................. 3-4
Tubehead Mineral Oil Safety ........................................................................ 3-4
Proper Disposal of Electronic Equipment ........................................ 3-5
Chapter 4 - Cleaning and Disinfection
Protect the Patient ......................................................................... 4-1
Use Caution with Disinfectants ...................................................... 4-1
Chapter 5 - System Startup and Shutdown
Turn System On ............................................................................. 5-1
Turn System Off ............................................................................. 5-2
Install/Release CCD Sensor ............................................................ 5-3
Install .......................................................................................................... 5-3
Release ........................................................................................................ 5-4
Table of Contents

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032-0275-EN Rev 1-iv
Chapter 6 - Controls and Indicators
Power Switch ................................................................................. 6-1
Main Control Panel ........................................................................ 6-1
Select Projection .......................................................................................... 6-3
Select Patient Size ....................................................................................... 6-3
Automatic Exposure Control (AEC) ................................................................ 6-4
Set Technique Factors .................................................................................. 6-5
Patient Positioning Controls ......................................................................... 6-6
Headrest Controls .................................................................................6-6
Rotating Imaging Assembly Height Controls ..........................................6-6
Lasers Control .......................................................................................6-7
Reset ........................................................................................................... 6-7
Demo Mode .................................................................................................. 6-8
Ceph Control Panel ........................................................................ 6-9
Primary Collimator Settings ......................................................... 6-10
Setting for Pan Projections ......................................................................... 6-10
Settings for Ceph Projections ..................................................................... 6-11
Setting for Transcan Projections ................................................................. 6-11
Exposure Handswitch .................................................................. 6-12
System Icons ............................................................................... 6-12
Status Icon ................................................................................................. 6-12
GX Driver Icon ............................................................................................ 6-14
Chapter 7 - Standard Pan Projection
Prepare the Orthoralix 9200 DDE ................................................... 7-1
Prepare Patient .............................................................................. 7-5
Place Patient into Position ............................................................................ 7-5
Adjust Patient’s Head Position ..................................................................... 7-7
Make Exposure ............................................................................ 7-10
Chapter 8 - Other Panoramic Projections
Child Panoramic ............................................................................ 8-1
Orthogonal Dentition ..................................................................... 8-2
Patient Positioning ....................................................................................... 8-2
Left and Right Orthogonal Half-Dentition ....................................... 8-2
Left-Half Panoramic and Right-Half Panoramic ............................... 8-3
Lateral Exposure TMJ ..................................................................... 8-3
Operation .................................................................................................... 8-3

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Patient Positioning ....................................................................................... 8-4
Frontal TMJ ................................................................................... 8-5
Operation .................................................................................................... 8-6
Patient Positioning ....................................................................................... 8-6
Frontal Dentition ............................................................................ 8-6
Maxillary Sinuses, Frontal View ..................................................... 8-7
Left and Right Maxillary Sinus, Lateral View ................................... 8-7
Operation ..................................................................................................... 8-7
Chapter 9 - Problem Prevention and Solutions
Correcting Image Distortions ......................................................... 9-1
Proper Patient Positioning ............................................................................ 9-2
Back Up Patient Image Data ........................................................... 9-6
Minimum Hardware Requirements ................................................. 9-6
Computer ..................................................................................................... 9-6
Hard Disk ..................................................................................................... 9-6
Video Card ................................................................................................... 9-6
Network Card ............................................................................................... 9-7
Monitor ........................................................................................................ 9-7
User Programs ............................................................................... 9-7
Set Language ............................................................................................... 9-7
Set Exposure Factors .................................................................................... 9-7
Density Test ................................................................................................. 9-8
AEC Default ................................................................................................. 9-8
Default Values .............................................................................................. 9-8
Messages and Alarms .................................................................... 9-8
Collimator .................................................................................................... 9-8
Operator Release ......................................................................................... 9-8
Movement Halted ......................................................................................... 9-8
Cooling Down ............................................................................................... 9-9
DMU Not Present .......................................................................................... 9-9
DMU Misplaced ............................................................................................ 9-9
CEPH BAY Rotated ........................................................................................ 9-9
DMU Fault .................................................................................................... 9-9
No Connection ............................................................................................. 9-9
DMU Not Detected ........................................................................................ 9-9
Transfer Error ............................................................................................. 9-10
HW Fault ### .............................................................................................. 9-10

Orthoralix 9200 DDE
032-0275-EN Rev 1-vi
Host Unavailable ....................................................................................... 9-10
Host Busy .................................................................................................. 9-10
Chapter 10 - Ceph Projections
Prepare the Orthoralix 9200 DDE ................................................. 10-2
Prepare the patient ...................................................................... 10-7
Latero-Lateral, Antero-Posterior, and Postero-Anterior ............................... 10-7
Carpus ....................................................................................................... 10-9
Make the exposure ...................................................................... 10-9
Setting the soft tissue filter ....................................................... 10-12
Chapter 11 - Transcan Mode
Transcan Projections ................................................................... 11-1
Transcan Positioning Device ........................................................ 11-2
Positioning Device Templates ..................................................................... 11-3
Maxilla Template ................................................................................11-4
Mandible Template .............................................................................11-5
Transcan Projection ..................................................................... 11-6
Take Dentition Impressions ........................................................................ 11-6
Preliminary Alignment ................................................................................ 11-8
Align Impression - Upper Jaw ...............................................................11-9
Align Impression - Lower Jaw .............................................................11-11
Align Mandibular Profile ...................................................................11-12
Prepare the Orthoralix 9200 DDE ............................................... 11-16
Prepare Patient .......................................................................... 11-18
Place Patient into Position ........................................................................ 11-18
Position Patient’s Head ............................................................................ 11-20
Make Exposure .......................................................................... 11-21
Chapter 12 - Technical Test Phantom
Chapter 13 - AEC MODE
Using AEC .................................................................................... 13-5
Viewing AEC kV Corrections ......................................................... 13-6
Changing Technique Factors ........................................................ 13-6
Appendix A - Technical Data
Appendix B - Technique Factors

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Modality: BASIC ............................................................................B-1
Modality: DMF ...............................................................................B-2
Modality: CEPH ..............................................................................B-3
Modality: TRANSCAN .....................................................................B-4
Appendix C - X-ray Projection Geometries
Appendix D - Manufacturer’s Declaration
Appendix E - Classification and Standards
Classification ................................................................................. E-1
Standards ..................................................................................... E-1
Appendix F - Multi-room Management
Multi-room Function ...................................................................... F-1
Used Terminology .........................................................................................F-1
Preliminary Operations .................................................................................F-1
Icons .............................................................................................................F-2
Taking Control of the System .........................................................................F-2
Network Inspection through the Main Tab .....................................................F-3

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1-1032-0275-EN Rev 1
Chapter
1About this Manual
This manual contains original instructions that describe the Gendex Orthoralix
9200 DDE X-ray image acquisition system that operates in real time. The
radiographic geometric projections provided by the Orthoralix 9200 DDE
system are of greatest interest for dentists, surgeons, and maxillo-facial
radiologists.
Panoramic assembly
Optional Cephalometric Assembly

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Intended Use
This manual is intended to assist the user in the safe and efficient 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
qualifications and, if relevant, having adequate training on the particular
equipment, especially regarding protective measures such as radiation
protection.
Ensure that existing legal regulations regarding installation of the equipment
are observed. Observe all legal regulations regarding operation of the
equipment.
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 subsequent non-compliance, damage,
injury, defect and/or other malfunction.
Conventions Used in this Manual
When information requires special attention, text is placed in a note:
NOTE: Notes highlight important information.
Information intended to prevent damage to the machine or loss of data is
placed in a caution.
CAUTION
Damage to the machine or a loss of data is possible.
Information intended to prevent serious or fatal injury is displayed as a
general warning.
WARNING
Serious or fatal injury is possible.
For specific dangers, the warning is more explicit.
WARNING
There is an electrical hazard. Serious or fatal injury is possible.

1-3032-0275-EN Rev 1
About this Manual
WARNING
There is a laser radiation hazard. Serious or fatal injury is possible.
WARNING
There is a radiation hazard. Serious or fatal injury is possible.
Trademarks Used in this Manual
•Gendex® and Orthoralix® are Registered Trademarks of Gendex
Dental Systems
•VixWin™ Platinum is a trademark of Gendex Dental Systems
•Microsoft®, Windows®, Windows2000®, WindowsXP®, Windows
Vista®, are registered trademarks of Microsoft Corporation in the
United States and other countries

Orthoralix 9200 DDE
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2-1032-0275-EN Rev 1
Chapter
2System Description
The Orthoralix 9200 DDE connected to a computer comprises the system. The
system provides panoramic radiography of the dento-maxillo-facial area.
When the ceph assembly is attached to the column, the system can provide
cephalometric radiography. (See page 2-4.) A variety of geometric projections
for different diagnostic purposes are available in both panoramic and
cephalometric modes.
Panoramic assembly
Optional Cephalometric Assembly

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Major Components
Most components in the system are part of the motorized rotating imaging
assembly. The rotating imaging assembly is mounted to the counter-balanced
motorized column (fixed to the wall or to an optional free-standing base).
Independent, microprocessor-controlled stepper motors control the
movement of the rotating imaging assembly as it moves around the patient’s
head during the exposure. The beam from the X-ray tube is collimated by a slit
diaphragm and is projected on the digital sensor. The digital sensor then
captures the image information and transfers it to the operating computer.
6
1
4
5
5b
2
3
5a
7
1. Column
2. Main control panel
3. Housing for the Pan CCD
(Charge Coupled Device) sensor
4. Pan CCD sensor (also referred
to as the “DMU”)
5. X-ray generator housing
a. X-ray tubehead assembly
(located inside housing)
b. Primary collimator
6. Rotating imaging assembly
7. Exposure handswitch

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System Description
In preparation for the panoramic exposure, the motorized rotating imaging
assembly is moved out of the way allowing the patient to move into the initial
position. The headrest, hand grip, bite guide, and positioning mirror are used
to establish the initial patient position. Lasers aid in establishing the final
position of the patient’s head.
5
4
1
2
3
1. Positioning mirror
2. Adjustment lever for Frankfurt plane laser setting
3. Hand grip
4. Bite guide (can be replaced with the transparent chin rest)
5. Headrest

Orthoralix 9200 DDE
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The ceph assembly option adds the components required for cephalometric
radiolography:
1
1. Ceph control panel
2. Ceph arm
3. Secondary collimator
4. Cephalostat
2
5. Ceph CCD sensor
6. Release buttons on the sensor
7. Power LED
3
4
5
6
7

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System Description
The nasion support and ear rods aid in positioning the patient’s head. The
knob is turned to fix or release the nasion support. The lever for the nasion
support moves it forward or backward. The lever for the ear rods moves them
in or out.
3
2
1
1. Nasion support
2. Nasion support lever
3. Nasion support knob
4. Ear rods
5. Ear rods lever
4
5

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Labels - Location and Descriptions

2-7032-0275-EN Rev 1
System Description
Label Description
System ID
Manufacturer and responsible
INPUT VOLTAGE REQUIREMENTS
LONG TERM RATING
MAX. MOMENTARY RATING
Primary Collimator ID
CERTIFICATION
Product complies with radiation
performance standards under the
Federal Food, Drug, and Cosmetic
Act
Tubehead ID
CERTFICATION
Product complies with radiation
performances standard under the
Federal Food, Drug, and Cosmetic
act
Sensor ID
Manufacturer and responsible
(93/42/EEC)
DMU UNIT:
REF:
SN:
X-ray Warnings
Caution X-Rays
To be Operated only by Authorized
Personnel. See Operator’s
Instructions.
Warning - This X-Ray Unit may be
Dangerous to Patient and
Operator unless Safe Exposure
Factors and Operating Instructions
and Maintenance Schedules are
Observed.

Orthoralix 9200 DDE
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Laser Aperture
LASER RADIATION
DO NOT STARE INTO BEAM
CLASS II LASER PRODUCT
650nm, 1mWI
EC60825-1 Ed.2 (2007)
Symbol Description
IEC Label
Type B: Protection against electrical shock (IEC
60601-1)
Caution
Consult written instructions in this Manual.
Warning
This X-Ray unit may be dangerous to patient and
operator unless safe exposure factors and
operating instructions are observed.
Warning
Electrical Hazard, Authorized Personnel only.
Warning
Laser energy present.
X-Ray Generator
Recycle Label
Dispose of in accordance with your country’s
requirements. There is material in the system
that must be separately collected and recycled in
accordance with the European Waste Electrical
and Electronic Equipment (WEEE) Directive.
Beware of moving mechanical parts
Earth Ground