User Manual

Installation Manual
Panoramic X-ray System

Gendex Dental Systems Authorized Representative:

901 West Oakton Street KaVo Dental GmbH
Des Plaines, IL 60018 U.S.A. Bismarckring 39
Tel 1-888-275-5286 88400 Biberach, Germany
Fax 1-847-550-1322 www.gendex-dental.com
www.gendex.com www.kavo.com
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® 8500. The
ORTHORALIX 8500 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.
 Table of Contents

Chapter 1 - About this Manual

Intended Use ...................................................................................................... 1-2
Conventions Used in this Manual ........................................................................ 1-2

Chapter 2 - System Description

Major Components .............................................................................................. 2-1
Labels - Location and Descriptions .................................................................... 2-3

Chapter 3 - Safety
Emergency Stop (not on all models) .................................................................... 3-1
Radiation Protection ........................................................................................... 3-1
Electrical Hazard ................................................................................................. 3-2
Mechanical Hazard .............................................................................................. 3-2
Explosion Hazard ................................................................................................ 3-2
Laser Radiation Hazard ....................................................................................... 3-3
Anatomical Reference Indications ....................................................................... 3-4
Tubehead Mineral Oil Safety .......................................................................................3-4
Proper Disposal of Electronic Equipment ............................................................. 3-5

Chapter 4 - Cleaning and Disinfection

Patient Protection ............................................................................................... 4-1
Caution with Disinfectants .................................................................................. 4-1

Chapter 5 - System Startup and Shutdown

Turning the System On ........................................................................................ 5-1
Turning the System Off ........................................................................................ 5-3

Chapter 6 - Controls and Indicators

Power Switch ...................................................................................................... 6-1
Main Control Panel .............................................................................................. 6-1
Selecting a Projection .................................................................................................6-3
Selecting Patient Size .................................................................................................6-3
Setting Technique Factors ...........................................................................................6-4
Reset ..........................................................................................................................6-4
Demo Mode ................................................................................................................6-5
Column Control Panel and Emergency Stop Button .............................................. 6-6
Emergency Stop (not on all models) .................................................................... 6-6

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Orthoralix 8500 DDE

Power-save mode .......................................................................................................6-7

Power ON LED .............................................................................................................6-7
Rotating Imaging Assembly Controls ...........................................................................6-8
Lasers Control .............................................................................................................6-8
Exposure Handswitch .......................................................................................... 6-9
System Icons ...................................................................................................... 6-9
Status Icon .................................................................................................................6-9
GX Driver Icon ...........................................................................................................6-10

Chapter 7 - Standard Pan Projection

Prepare the Orthoralix 8500 DDE ......................................................................... 7-1
Prepare the Patient ............................................................................................. 7-4
Place Patient into Position ..........................................................................................7-4
Adjust Patient’s Head Position ....................................................................................7-6
Take Exposure ..................................................................................................... 7-8

Chapter 8 - Other Panoramic Projections

Child Panoramic .................................................................................................. 8-1
Lateral Exposure TMJ ........................................................................................... 8-2
Operation Variation ....................................................................................................8-2
Positioning Instructions ..............................................................................................8-2
Frontal TMJ ......................................................................................................... 8-5
Positioning Instructions ..............................................................................................8-5
Operation Variation ....................................................................................................8-5

Chapter 9 - Problem Prevention and Solutions

Correcting Image Distortions ............................................................................... 9-1
Proper Patient Positioning ..........................................................................................9-2
Backup Image Patient Data ................................................................................. 9-5
Minimum Hardware Requirements ...................................................................... 9-6
Computer ....................................................................................................................9-6
Hard Disk ....................................................................................................................9-6
Video Card ..................................................................................................................9-6
Network Card ..............................................................................................................9-6
Monitor ......................................................................................................................9-6
Errors .................................................................................................................. 9-7

Appendix A - Technical Data

Appendix B - Technique Factors
Modality: Pan ...................................................................................................... B-1

Appendix C - X-ray Projection Geometries

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 Orthoralix 8500 DDE

Appendix D - Manufacturer’s Declaration

Appendix E - Classification and Standards
Classification .......................................................................................................E-1
Standards ............................................................................................................E-1

032-0253-EN Rev 3 -v
Orthoralix 8500 DDE

-vi 032-0253-EN Rev 3

 Chapter About this Manual
1

This User Manual contains original instructions by Gendex Dental Systems

and describes the Gendex Orthoralix 8500 DDE, an X-ray image acquisition
system that operates in real time. The radiographic projections provided by
the Orthoralix 8500 DDE are of greatest interest for dentists, surgeons, and
maxillo-facial radiologists.

032-0253-EN Rev 3 1-1

Orthoralix 8500 DDE

Intended Use
The Orthorolix 8500 DDE Panoramic Dental X-ray System is to be used as an
extraoral source of X-rays for imaging of the dento-maxillo-facial area.

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.

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 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.

1-2 032-0253-EN Rev 3

 About this Manual

WARNING
There is an electrical hazard. Serious or fatal injury is possible.

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.

032-0253-EN Rev 3 1-3

Orthoralix 8500 DDE

1-4 032-0253-EN Rev 3

 Chapter System Description
2

The Orthoralix 8500 DDE connected to a computer comprises the system.

Major Components
8

2
1

3
7

ATTENTION RAYONS - X
OPERATION SEULEMEMENT PAR
DU PERSONNEL AUTORISE. VOIR

6
MANUEL DE L’OPERATEUR.

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 ARE
OBSERVED.

5
4

1. Rotating imaging assembly 6. Pan CCD sensor

2. Column 7. X-ray generator assembly
3. Column control panel 8. Exposure handswitch
4. Emergency stop 9. Remote exposure switch
(not on all models) (may not be installed)
5. Main control panel

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.

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Orthoralix 8500 DDE

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 head support arms,
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.

1. Hand grip
2. Bite block (can be replaced with the chin rest)
3. Head support arms

2-2 032-0253-EN Rev 3

 System Description

Labels - Location and Descriptions

Gendex Dental Systems
Des Plaines, IL USA

120V 50/60 Hz 1620VA

2.0A ; 13.5A
34SL

Label No. 408-0349

230V 50/60 Hz 1955VA
1.1A ; 8.5A CLASS 1
TYPE B
Cer tific ation: Produc t complies with
FD A perfor mance s tandar ds for
Medical Equipment
radiation and laser produc ts exc ept
CLASSIFIED UL60601-1, IEC60601-1
for dev iations purs uant to Laser
& CAN/CSA-C22.2 No. 601.1-M90
Notice No. 50, dated 24 June 2007
IEC60825-1:2001

REF

E-Stop
Not on all models

ATTENTION RAYONS - X
OPERATION SEULEMEMENT PAR
DU PERSONNEL AUTORISE. VOIR
MANUEL DE L’OPERATEUR.

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 ARE
OBSERVED.

ATTENTION RAYONS - X
Gendex Dental Systems OPERATION SEULEMEMENT PAR
Des Plaines, IL USA DU PERSONNEL AUTORISE. VOIR
MANUEL DE L’OPERATEUR.
0.4 IEC 60336 2.5 Al/85 IEC 60522
CAUTION X-RAYS
Label No. 408-0343

GENDEX GX 85-15 SN TO BE OPERATED ONLY BY

AUTHORIZED PERSONNEL. SEE
REF SN OPERATOR’S INSTRUCTIONS.
WARNING - THIS X-RAY UNIT MAY
BE DANGEROUS TO PATIENT AND
OPERATOR UNLESS SAFE
EXPOSURE FACTORS,
Certification: Product complies with radiation performance OPERATING INSTRUCTIONS AND
standards under the Federal Food, Drug, and Cosmetic act. MAINTENANCE SCHEDULES ARE
OBSERVED.

Panoramic X-Ray Beam Limiter

Gendex Dental Systems REF 112-1143G1
C er t ifica ti on - C omp lie s w ith FD A r a dia tio n
p er fo rma nce s tan dar ds 2 1 C FR, su b ch a pt er J .
SN 09 - 2009
11-1234567DP Des Plaines, IL USA

CAUTION
LASER RADIATION
DO NOT STARE INTO BEAM

Wavelength: 650nm, output Power ≤1mW

CAUTION Complies with FDA performance standards for

laser products except for deviations pursuant
to Laser Notice No. 50, dated June 24, 2007
LASER RADIATION CLASS II LASER PRODUCT
DO NOT STARE INTO BEAM

Wavelength: 650nm, output Power ≤1mW

Complies with FDA performance standards for
laser products except for deviations pursuant
to Laser Notice No. 50, dated June 24, 2007
CLASS II LASER PRODUCT

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Orthoralix 8500 DDE

Label Description

Check Jumper
Position the jumper for the
Position the jumper for the input
Input voltage being used.
This tag must be removed
Before reassembling cover.
J9 J8 J10 J9 J8 J10 voltage being used. This tag must
Placez le pont en fonction
de La tension de réseau utilisée.
120V 230V be removed before reassembling
Cette étiquette doit être retirée avant de replacer le couvercle.

Posizionare il ponticello per la tensione di rete appropriata. cover.

Questa etichetta deve essere rimossa prima di richiudere
La copertura.

408-0390P1
Poner el jumper en relación con la tensión de red utilizada.
Esta etiqueta debe ser removida ante de tapar.

Positionieren Sie den Jumper entsprechend der Netzeingangsspannung.

Ettikett entfernen, bevor die Abdeckung wieder montiert wird.

System ID
Certification: Product complies
with FDA performance standards
for radiation and laser products
except for deviations pursuant to
Laser Notice No. 50, dated 24 June
2007.

Panoramic X-ray Beam Limiter

Certification - Complies with FDA
radiation performance standards
21 CFR, sub chapter J.

Tubehead
Certification: Product complies
with radiation performances
standard under the Federal Food,
Drug, and Cosmetic act.

X-ray Warnings
ATTENTION RAYONS - X
OPERATION SEULEMEMENT PAR Caution X-rays
DU PERSONNEL AUTORISE. VOIR
MANUEL DE L’OPERATEUR. To be Operated only by Authorized
CAUTION X-RAYS
TO BE OPERATED ONLY BY Personnel. See Operator’s
AUTHORIZED PERSONNEL. SEE
OPERATOR’S INSTRUCTIONS. Instructions.
WARNING - THIS X-RAY UNIT MAY
BE DANGEROUS TO PATIENT AND
OPERATOR UNLESS SAFE Warning - This X-ray Unit may be
EXPOSURE FACTORS,
OPERATING INSTRUCTIONS AND
MAINTENANCE SCHEDULES ARE
Dangerous to Patient and
OBSERVED.
Operator unless Safe Exposure
Factors and Operating Instructions
and Maintenance Schedules are
Observed.

2-4 032-0253-EN Rev 3

 System Description

Laser Aperture
CAUTION
LASER RADIATION
DO NOT STARE INTO BEAM
Wavelength: 650nm, output
Power < 1mW
Complies with FDA performance
standards for laser products
except for deviations pursuant to
Laser Notice No. 50, dated June
24, 2007
CLASS II LASER PRODUCT

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.

032-0253-EN Rev 3 2-5

Orthoralix 8500 DDE

Symbol Description

Do not connect phone to the connector.

Earth Ground

Mains Hot Wire

Mains Neutral Wire

Emergency Stop
(not on all models)

2-6 032-0253-EN Rev 3

 Chapter Safety
3

This system features continuous operation (stand-by mode). X-rays are emitted only when the
exposure handswitch button is pressed.

With correct handling and installation, proper maintenance and servicing will ensure safe and
efficient operation. The equipment must never be used if there are any electrical, mechanical,
or radiation defects whatsoever.

Refer to the Installation Manual for the recommended maintenance activities (for example,
checking wear and tear on cables, belts, and gears). Modifications and additions to the
equipment must be carried out only by personnel or third parties that are expressly authorized
by, and must comply with the applicable legal requirements as well as with the generally
accepted technical regulations.

Emergency Stop (not on all models)

In the event of an emergency (any moving component collides with any parts of the equipment
or items in the environment, or that could cause physical injury to the patient), the operator
and/or patient should utilize the Emergency Stop button to turn off the power to all moving
parts in order for the patient to be moved safely from the machine.

If an emergency arises where it becomes necessary to interrupt a scan, use the following
procedure.
1. Press the Emergency Stop button.
2. When you have determined that you can safely move the patient away
from the device, make sure the patient’s head will not touch the top of the
device and help the patient move away from the unit.

Radiation Protection
The system implements various built-in measures to prevent excess radiation (leakage,
secondary, and scattered) from reaching the patient, the operator, or other people.

It is the responsibility of the qualified 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.

032-0253-EN Rev 3 3-1

Orthoralix 8500 DDE

To protect the patient against unnecessary radiation, other accessories, in addition to those
provided on the system, can be used whenever necessary.

Care must be taken that these accessories do not interfere with the proper radiographic
operation of the apparatus. For example, lead shield collars should be avoided as they may
block the useful X-ray beam.

The following points must always be observed:

• Maintain a safe distance of at least 6 ft (2 m) 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 lead glass shielding, during
exposure.
• A film badge should be carried for personal monitoring.

Electrical Hazard
Only qualified service personnel should remove the covers or otherwise obtain access to parts
of the system.

The system may only be used in rooms which comply with the relevant national and/or
international legislation and recommendations (for example, CE and others) concerning
electrical safety in rooms used for medical purposes.

Always disconnect or switch off the equipment before cleaning or disinfecting to avoid the risk
of shock.

Do not allow any liquid to enter the system, as this could cause short-circuits and corrosion.

Mechanical Hazard
When the system is in use, ensure that no body parts or clothing can get caught in any moving
parts.

Explosion Hazard
This system is not suitable for use in the presence of flammable gases or vapors. Certain
disinfectants vaporize and form explosive mixtures. If such disinfectants are used, the vapors
must be left to dissipate before the system is powered up again. For more information, refer to
“Caution with Disinfectants” on page 4-1.

3-2 032-0253-EN Rev 3

 Safety

Laser Radiation Hazard

CAUTION
Use of controls or adjustments, or performance of procedures other than
those specified in this manual, may result in hazardous laser radiation
exposure.

This equipment is designed in accordance with IEC 60825-1:2001. Although compliant with
laser safety rules, it is good practice for the operator to avoid exposing anyone’s eyes to laser
beams.

The position of laser sources are identified by means of the following warning labels (black on
yellow).

The laser for the lighting of the midsagittal plane (vertical laser beam) is positioned on the
column above the rotating imaging assembly.

Two lasers for the lighting of the Frankfurt plane (horizontal laser beam) and the laser beam that
is aligned with the lateral incisor roots (cuspid laser beam) are positioned to the left of the
sensor.

032-0253-EN Rev 3 3-3

Orthoralix 8500 DDE

CAUTION
LASER RADIATION
DO NOT STARE INTO BEAM

Wavelength: 650nm, output Power ≤1mW

Complies with FDA performance standards for
laser products except for deviations pursuant
to Laser Notice No. 50, dated June 24, 2007
CLASS II LASER PRODUCT

CAUTION
LASER RADIATION

Midsagittal plane laser

DO NOT STARE INTO BEAM

Wavelength: 650nm, output Power ≤1mW

Complies with FDA performance standards for
laser products except for deviations pursuant
to Laser Notice No. 50, dated June 24, 2007
CLASS II LASER PRODUCT

2 lasers:
Frankfurt plane laser
Cuspid laser

Anatomical Reference Indications

It is strongly recommended to pay attention to the L and R letters to identify the anatomical side
and to avoid any mistake during the evaluation.

Once the Pan procedure 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. No letter is placed in correspondence of the
center of the mouth.

Tubehead Mineral Oil Safety

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.
Call your local Service Representative to repair the problem.
In case of minor leaks, the oil can be wiped away with a dry cloth, wearing
protective gloves and flush eyes with copious amounts of water.

3-4 032-0253-EN Rev 3

 Safety

Proper Disposal of Electronic Equipment

NOTE: The following information is valid in the European Union. If you wish to
discard this product, please contact your local authorities or dealer and ask
for the correct method of disposal.

This symbol on the products and/or accompanying documents means that used
electrical and electronic products should not be mixed with general household waste.

For proper treatment, recovery, and recycling, please take these products to designated
collection points where they will be accepted on a free-of-charge basis. Alternatively, in some
countries, you may be able to return your products to your local retailer upon the purchase of
an equivalent new product.

Disposing of this product correctly will help to save valuable resources and prevent any
potential negative effects on human health and the environment which could otherwise arise
from inappropriate waste handling.

Please contact your local authority for further details of your nearest designated collection
point. Penalties may be applicable for incorrect disposal of this waste in accordance with
national legislation.
NOTE: For Business users in the European Union
If you wish to discard electrical and electronic equipment, please contact
your dealer or supplier for further information.

032-0253-EN Rev 3 3-5

Orthoralix 8500 DDE

3-6 032-0253-EN Rev 3

 Chapter Cleaning and Disinfection
4

Patient Protection
All parts coming in direct contact with the patient must be kept clean and
disinfected.

Always replace the disposable hygienic covers on the bite before positioning
a new patient. These covers should be stored in a clean, dry environment and
not exposed to direct sunlight or UV radiation.

The bite block and chin rest can be disinfected by immersion in a cold
sterilizer, and can be steam sterilized in an autoclave up to 125°C.

All other parts used for patient positioning that come in direct contact with the
patient must be kept clean and disinfected. Use an appropriate disinfectant
following the manufacturer's guidelines.

Caution with Disinfectants

CAUTION
The method of disinfection used should comply with current regulations and
recommendations, including those concerning the prevention of explosive
hazards.

• Always disconnect the system from the mains supply before

cleaning or disinfection.
• No water or any other liquids should be allowed to enter the
equipment, as this can cause short-circuits and corrosion.
• Accessories and connecting cables should be cleaned or disinfected
using a damp cloth followed by a rubbing down with a dry cloth.
• Do not use solvents (toluene, benzene, etc.), corrosive cleaning
agents or abrasive polishing materials.

032-0253-EN Rev 3 4-1

Orthoralix 8500 DDE

CAUTION
It is not recommended to use spray disinfectants as the disinfectants may
permeate into the system and cause short circuits or corrosion. If an atomizer
is used for disinfection, follow the procedure provided below to protect the
system.

1. Turn the system off and disconnect the system from the mains supply.
2. Cover the system carefully with a plastic sheet.
3. Allow the system to cool down to prevent convection currents from
drawing the vapors into the system.
4. Disperse the disinfectant.
5. Allow the vapors to dissipate before the equipment is returned to use.
6. Remove the plastic sheeting.
7. Reconnect the system to the mains supply and turn the system on.

4-2 032-0253-EN Rev 3

 Chapter System Startup and
5 Shutdown

Turning the System On

1. Turn on the system by pressing the power switch at the base of the
column. The POWER ON LED on the column control panel will light up, as
will the lamps for the currently selected patient size, the mA display, and
the kV display.

NOTE: After approximately 30 minutes of not being used, the system

goes into a power-saving mode. Pressing the power-save button
brings the system back to where it was prior to going into the
power-save mode.

032-0253-EN Rev 3 5-1

Orthoralix 8500 DDE

2. Ensure that the computer/software is activated.

3. Wait until “dE” is no longer seen in the mA display and press Reset.

NOTE: If after pressing the Reset button “dE” remains, there is a

connection problem. Refer to Status Icon on page 6-9 to verify the
status of the system. The problem must be resolved before any
exposures can be made.
4. Press Reset again to set the device to the Ready state.

If the above mentioned operation is carried out correctly, the system is reset
to the ready state. The Ready LED on the main control panel lights up to
indicate the reset condition. The ready state is a prerequisite for starting any
exposure program.

5-2 032-0253-EN Rev 3

 System Startup and Shutdown

Turning the System Off

NOTE: It is neither necessary nor advisable to turn the unit off between
uses. After approximately 30 minutes of not being used, the unit
goes into a power-saving mode. When the system goes into
power-save mode, it automatically saves data and system status
and then shuts off power to all possible components. The display
and control panel buttons become inactive (except for the power-
save button).

On the computer, exit the active software. To turn off the computer, choose
Start > Shut Down. In the window that displays, ensure the selection is Shut
down and then click OK.

Turn off the system by pressing the power switch at the base of the column.

032-0253-EN Rev 3 5-3

Orthoralix 8500 DDE

5-4 032-0253-EN Rev 3

 Chapter Controls and Indicators
6

Power Switch
Refer to page 5-1 for the location of the power switch.

Main Control Panel

Each button on the control panel is labeled with a pictogram related to the
associated function. The operator does not use more than one button to
initiate a given function. Where applicable, the function is confirmed by an
associated LED light and/or audible alarm.

ATTENTION RAYONS - X
OPERATION SEULEMEMENT PAR
DU PERSONNEL AUTORISE. VOIR
MANUEL DE L’OPERATEUR.

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 ARE
OBSERVED.

88 88

88 88

032-0253-EN Rev 3 6-1

Orthoralix 8500 DDE

Reset system

88
ON - System ready

Turn on Demo mode (no X-ray emission)

ON Emitting X-rays

88 ON - Operation has been inhibited due to a

tubehead cooling cycle.

Scroll through projection options starting at

Pan (bottom), then Lateral TMJ (middle), and
then Frontal TMJ (top).

ON - Projection selected

Increase or decrease kV level (2 kV

increments)

Not used

Select patient size


ON- Patient size selected 
(child, small, medium, large)

6-2 032-0253-EN Rev 3

 Controls and Indicators

Selecting a Projection
When the system is turned on, the Standard Pan modality is set and the
relevant projection LED lights up.

To select a projection, press to toggle through the three choices: Pan ,

Lateral TMJ , and Frontal TMJ . Lateral TMJ has an eight second
exposure and Frontal TMJ has a six second exposure.

Selecting Patient Size

Press the Patient size button to cycle
through the selections.

There are four patient size

selections:
• pedo (child)
• small (small female or
teenager)
• medium (average size
female or male)
• large (large adult male or
elderly person with a calcified mandible)
NOTE: The child panoramic projection is activated when the patient size
selection is pedo. Refer to page 8-1 for more information about this
projection.
NOTE: Medium size patient is selected by default.

032-0253-EN Rev 3 6-3

Orthoralix 8500 DDE

Setting Technique Factors

The exposure technique factors related to

88
the chosen selection (kV and mA) will be
set and displayed.

If desired, the kV value can be modified.

88
The mA value can only be viewed. The
exposure time is determined by the
selected patient size and is signified by the
LEDs below the size selection options on
the main control panel.
NOTE: Manually increasing the kV value
above the pre-programmed value
will result in an increase in film
blackening with a decrease in the
contrast.

You can always reset to the default

technique factors by selecting the relevant
patient size.

Reset
The Reset button is used to return the
rotating imaging assembly to the default
starting position.
NOTE: When the rotating imaging
assembly is repositioned, X-rays are
not emitted. The X-ray LED turns off
and there is no audible alarm.

If the above mentioned operation is carried out correctly, the system is reset
to the ready state. The Ready LED on the main control panel lights up to
indicate the reset condition. The ready state is a prerequisite for starting any
exposure program.

6-4 032-0253-EN Rev 3

 Controls and Indicators

Demo Mode

CAUTION
As the demo mode is usually followed by the actual exposure, remove all
metal articles (glasses, removable dentures, earrings, etc.) before positioning
the patient. 
If he/she is to be fitted with a lead-lined apron for radiation protection, make
sure that the neck is not covered, because this will cause unexposed areas in
the radiograph.

To perform a demonstration (a no-radiation simulation of the currently

selected projection or modality), press the Demo mode button. Press and hold
the exposure handswitch button. Releasing the exposure handswitch button
stops movement. Press the Demo mode button to return to normal mode.

Press the Reset button to return the rotating imaging assembly to the default
starting position.

032-0253-EN Rev 3 6-5

Orthoralix 8500 DDE

Column Control Panel and Emergency Stop Button

The control panel for the column is mounted directly on the column.

ATTENTION RAYONS - X
OPERATION SEULEMEMENT PAR
DU PERSONNEL AUTORISE. VOIR
MANUEL DE L’OPERATEUR.

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 ARE
OBSERVED.

Emergency Stop (not on all models)

The emergency stop button immediately halts the scan and turns off the
power to all moving parts in order for the patient to be moved safely from the
machine. Turn the button clockwise to reset.

6-6 032-0253-EN Rev 3

 Controls and Indicators

Turn OFF power-save mode

ON - Power on

Reset system

Move rotating imaging

assembly up

Move rotating imaging

assembly out (shifts lateral
light beam away from column)

Move rotating imaging

assembly in (shifts lateral light
beam towards column)

Move rotating imaging

assembly down

Turn on the lasers

Power-save mode
Press the power-save mode button to toggle the unit in and out of power-save
mode.

Power ON LED
This LED signifies when the system is not in the power-save mode.

032-0253-EN Rev 3 6-7

Orthoralix 8500 DDE

Rotating Imaging Assembly Controls

When positioning the patient in the machine, use the up and down buttons to
move the rotating imaging assembly up or down.

Constant pressure for more than 2 seconds will cause either of these buttons
to gradually accelerate until the movement is at the maximum speed.

When aligning the rotating imaging assembly with the patient’s head, use the
left and right buttons to shift the cuspid light beam to the correct position
(move the assembly away from or towards the column).

Lasers Control
Press this button to turn the lasers on and off.

6-8 032-0253-EN Rev 3

 Controls and Indicators

Exposure Handswitch
When the exposure handswitch button is pressed, X-rays are emitted. The
system provides two alerts: the X-ray LED on the main control panel lights up
and an audible alarm is emitted. (When a remote exposure switch is installed,
the same two alerts are provided at the switch.) The actual X-ray emission
starts 5 seconds after pressing the button. Must hold button for entire
exposure.

System Icons
These system icons display in the Windows system tray (near the clock):
• Status icon (the look of the icon changes according to the status)
• GX driver icon (only displays when the driver is installed correctly)

Status Icon
Exposures can only be made when the Status icon is green and blue as shown
in the following graphic:

Status: ready to capture images

This green and blue icon indicates the correct operation of the
Orthoralix 8500 DDEelectronics (including the CCD sensor), the connection
between the Orthoralix 8500 DDE and the CCD sensor, and the connection
between the Orthoralix 8500 DDE and the computer or networking device.

032-0253-EN Rev 3 6-9

Orthoralix 8500 DDE

These icons indicate different system conditions:

Icon Status

Large red X: 
- Faulty hardware condition
- Sensor calibration required

Small red X: CCD sensor not present

Magnifying glass: Connection problem

somewhere in the system

Red: Orthoralix 8500 DDE is not present on the

network

Yellow X: Computer/networking device

connected but does not have control

GX Driver Icon
When the Gendex driver is installed correctly, the Gx icon is shown in the
system tray.

Right-click this icon to display a menu for viewing and modifying data and
parameters common to all the Gendex imaging system products.

Double-click this icon to open a configuration panel which contains

information about the operation of the electronics, the software version, and
the characteristics of the CCD sensor.

6-10 032-0253-EN Rev 3

 Chapter Standard Pan Projection
7

Refer to Appendix B, Technique Factors, for the factory settings for this
projection. For the X-ray projection geometry, refer to Appendix C, X-ray
Projection Geometries.

The procedure to do a Standard Pan projection starts with preparing the

Orthoralix 8500 DDE:
• Select the standard Pan projection

Next the patient is prepared:

• Properly position the patient in the Orthoralix 8500 DDE
• Adjust the patient’s head position

The exposure is made.

NOTE: A quick reference guide indicating the options/actions necessary to
perform a standard panoramic exposure is located on the right side of
the column near the control panel.

Prepare the Orthoralix 8500 DDE

1. Press the Function button until the Standart Pan is selected.

032-0253-EN Rev 3 7-1

Orthoralix 8500 DDE

2. Press Reset. The system is in the ready state when the Ready LED is lit.

3. Press the Patient size selection button.

There are four patient size selections:

• pedo (child)
• small (small female or teenager)
• medium (average size female or male)
• large (large adult male or elderly person with a calcified mandible)
NOTE: The child panoramic projection is activated when the patient size
selection is pedo. Refer to page 8-1 for more information about this
projection.
NOTE: Medium size patient is selected by default.

4. If necessary, modify the preset exposure factors. (See page 6-4.)

7-2 032-0253-EN Rev 3

 Standard Pan Projection

5. Insert the supplied bite block (A) in the related seat. Tighten it firmly by
rotating the knob (C) (clockwise=tighten, counter-clockwise = loosen).
NOTE: For an edentulous patient, it is possible to use the supplied
transparent chin rest (B).

6. For hygienic reasons, cover the bite block with a disposable bite-guide
cover. These have been designed and developed for use with the
Orthoralix 8500 DDE system.

032-0253-EN Rev 3 7-3

Orthoralix 8500 DDE

Prepare the Patient

Place Patient into Position

NOTE: To help calm a nervous patient (for example, children) use the demo
mode to demonstrate the movement of the rotating imaging assembly.
(Refer to page 6-5.)

1. Open the head support arms.

2. Ask the patient to step into position in front of the handgrip with their
head between the head support arms.
3. Position the rotating imaging assembly up or down as required.

4. Place the patient close to the bite guide (or chin rest). The bite guide must
be at the level of patient’s mouth (occlusal plane); the chin rest must be
aligned with the patient’s chin.
5. Have the patient firmly grasp the handgrip with both hands as far forward
from the bite guide holder as possible. Ask the patient to move their feet
forward and together. Ensure the patient’s body is straight and slanted,
with the patient hanging slightly from the handgrip (according to the
patient’s physical ability to maintain this uncomfortable position during
the examination). The purpose of this position is to stretch the spine as

7-4 032-0253-EN Rev 3

 Standard Pan Projection

much as possible in order to decrease the artifact shadow that would

otherwise be cast into the image.

NOTE: It is possible for the patient to stand in a natural and more

comfortable position if they cannot hold the above described
position (for example, elderly people).

The positioning described in step 5 does not preclude the
possibility to correctly position a patient in a wheelchair.

6. If using the bite guide, ensure that the patient is not biting too far forward
(beyond the grooves).

NOTE: Edentulous patients should use the chin rest. If the chin rest is
used for dentate patients, he/she should bite so as to align lower
and upper incisors.

032-0253-EN Rev 3 7-5

Orthoralix 8500 DDE

Adjust Patient’s Head Position

Although the design of the lasers is compliant with the safety regulations
regarding lasers, it is good practice for the operator to avoid exposing his/her
eyes and the patient’s eyes to the laser beam. Warning labels indicate the
position of the laser sources. For the location of laser sources, refer to “Laser
Radiation Hazard” starting on page 3-3.

CAUTION
Performing procedures other than those specified in this manual, or using the
controls or adjustments other than as specified in this manual, may result in
hazardous laser radiation exposure.

1. Switch ON the positioning lasers.

NOTE: The lasers are timed and they will switch off automatically 
after 45 s.

2. With the center of the dentition aligned with the midline of the bite guide
or chin rest, check that the front vertical light beam is centered on the
patient’s mid-sagittal plane. If necessary, gently turn the patient’s head
to adjust.

3. Note the parallel horizontal stripes projected on the side of the patient’s
face. These horizontal stripes must be in alignment with the patient’s
Frankfurt plane (the plane passing through the lower margin of the left
orbit and the tragus at the external auditory meatus).Gently raise or lower
the rotating imaging assembly to tilt the patient’s head backwards or
forwards until the laser beam strips are in alignment with the patient’s
Frankfurt plane.

7-6 032-0253-EN Rev 3

 Standard Pan Projection

Patient’s
Frankfurt
plane aligned
with these
parallel laser
beams

NOTE: In step 4, the cuspid light beam indicates the front most position that
the X-ray focal trough will reach during the exposure. Normally, setting
the cuspid light beam at the center of the cuspid aligns the front most
position of the focal trough with the roots of the lateral incisors.

4. While ensuring that the patient doesn’t move, use the forward button or
the backward button to adjust the position of the rotating imaging
assembly until the cuspid light beam is positioned at the center of the
cuspid.


Nominal position is 5 mm
behind the groove of the
bite block
- If the incisor is straight,
adjust to Y < 5 mm
- If the incisor protrudes,
Cuspid light adjust to Y > 5 mm
beam
centered on
the cuspid

5. Continue to next page.

032-0253-EN Rev 3 7-7

Orthoralix 8500 DDE

Take Exposure
1. When the patient’s head is properly positioned, gently close the head
support arms until they are pressed lightly against the patient’s head.
NOTE: Use care when closing the head support wands. Rapid or abrupt
movement of the lever might cause the arms to snap
uncomfortably against the patient’s temples.

2. Ask the patient to press his/her tongue to the palate and to stay still
during the exposure. Make sure the patient does not shift position during
the exposure process.
3. Verify the correct system status icon displays in the system tray:

Orthoralix 8500 DDE is ready to

capture the images

NOTE: The exposure handswitch button must be kept firmly pressed during
the entire exposure procedure. Otherwise X-ray emission and rotating
imaging assembly movements will be stopped and an error code is
displayed. If this should happen, the unit must be reset, the patient
must be re-positioned, and the exposure must be repeated.

CAUTION
Repeating the exposure subjects the patient to unnecessary radiation. Keep
the exposure handswitch button firmly pressed during the entire exposure
procedure to prevent repeating the exposure.

7-8 032-0253-EN Rev 3

 Standard Pan Projection

4. Observing the applicable radiation safety procedures, take the exposure

by pressing and holding the exposure handswitch button.

5. During X-ray emission, preview images are continuously provided for the
imaging software to display. For imaging software that provides a preview
window, verify the correct image acquisition.

6. When the exposure cycle has been concluded, release the exposure
handswitch button. The final image is transferred to the imaging
software.

032-0253-EN Rev 3 7-9

Orthoralix 8500 DDE

7. Open the head support arms. Ask the patient to move out.

8. Reset the system.

To process the final image, refer to the manual for your imaging software.

7-10 032-0253-EN Rev 3

 Chapter Other Panoramic
8 Projections

Press the Function button repeatedly to scroll through the set of projections.
The lamp turns on for the projection selected (shown below with Lateral TMJ
selected).

Refer to Appendix B, Technique Factors, for the factory settings for each
projection. For the X-ray projection geometries, refer to Appendix C, X-ray
Projection Geometries.

Functional Button

Frontal Projection

Lateral Projection

Child Panoramic
NOTE: This standard panoramic projection is ativated when the patient size
selection is pedo (child).

Description Child panoramic is a common panoramic projection

adapted to the specific infantile morphology.
By taking advantage of the shorter shape of a child’s
jaw, it’s possible to achieve a good orthogonality of
the X-ray beam to the dentition in the premolar area,
and as a consequence un-deformed images of those
teeth with little crown overlap, while covering the
entire dento-maxillary complex including TMJ.

Operation Same as Standard Panoramic

Patient positioning

032-0253-EN Rev 3 8-1

Orthoralix 8500 DDE

Lateral Exposure TMJ

Description This is a projection of the temporo-mandibular

joint, both right and left sides where the TMJ is
viewed with projections along the major axis of
the condyles (sagittal view of the condyle).
Similar to a lateral projection, in this projection,
the condyle is generally not perpendicular to
the mid sagittal plane of the skull. It is possible
to repeat the exposure of the same patient with
open and closed mouth, whenever necessary,
in order to examine the condyle displacement
caused by the protrusion.

Operation Refer to Operation Variation below.

Patient positioning Refer to Postioning Instructions below.

Operation Variation
The operation is similar to the Standard Panoramic projection except that in
the TMJ program, the longitudinal pre-positioning displacement of the rotating
imaging assembly is inhibited, and the equipment always starts the exposure
cycle from the reset position at Y = 5 mm.

Positioning Instructions
1. Press the Function button until the
Standard Pan is selected.

2. Press Reset. The system is in the ready

state when the Ready LED is lit.
2

3. Press the Patient size selection button.

8-2 032-0253-EN Rev 3

 Other Panoramic Projections

4. Press the Function button repeatedly to

select Lateral TMJ.

5. Insert the supplied white flat

Chin Rest and tighten it firmly
into position.

6. Ensure the patient’s body is

straight and slanted, with the patient
hanging slightly from the handgrip.
Stretch the spine as much as possible in
order to decrease the artifact shadow
that would otherwise be cast into the
image.

032-0253-EN Rev 3 8-3

Orthoralix 8500 DDE

7. Place the ear plug end of the TMJ

Ruler in the right auditory meatus. 8

8. Switch on the positioning lasers.

NOTE: The lasers are timed and they will switch off automatically 
after 45 s.

9. Move the patient’s

head back and forth LASER
until the cuspid light
coincides with the
vertical line in the
TMJ ruler. The center
of the fossa should
be about 75 mm
behind this light
beam.

The angle between the major condylar axis and the perpendicular to the
median/sagittal plane is assumed to be 10°.

If the exact angle is known (this can be determined using the submento vertex
exam), it is possible to optimize the orthogonal incidence of the X-ray beam
relative to the major condylar axis, ensuring the highest possible diagnostic
value of the exposure: Position the patient with the cuspid light beam to
coincide with the reference values indicated on the TMJ ruler – for both open
and closed mouth projections.

8-4 032-0253-EN Rev 3

 Other Panoramic Projections

Frontal TMJ

Description This radiographic projection permits the

assessment of the exact shape of the condyle,
with coronal view (for the diagnosis of arthritis).
The frontal projection of the Temporo-
Mandibular Joint is obtained by means of the
so-called Reverse Geometry Projection. A
frontal view of both the right and left TMJ is
depicted on a single exposure. In combination
with the lateral TMJ projection, it allows a
complete diagnostic assessment of the TMJ.

Operation Refer to Operating Variations below.

Patient positioning Refer to Positioning Instructions below.

Positioning Instructions
1. Position the patient with the white chin rest (without the ridge).
2. Align the lateral vertical light with the lower canine.
3. Instruct the patient to keep the mandible as protruded as possible, or
open, so as to displace the condylar head forward, under the eminence.
4. Tilt the patient’s head forward so as to have the Frankfurt plane slightly
(approximately 5°) beyond the horizontal (cervical spine slightly more
extended than with the positioning for a standard radiograph). An
excessive tilt backwards may involve the overlap of the orbital base/
palatal vault on the area of the condyle of diagnostic interest.

Operation Variation
In the TMJ program, the longitudinal pre-positioning displacement of the
rotating imaging assembly is inhibited, and the equipment always starts the
exposure cycle from the reset position at Y = 5 mm.

032-0253-EN Rev 3 8-5

Orthoralix 8500 DDE

8-6 032-0253-EN Rev 3

 Chapter Problem Prevention and
9 Solutions

In order to assure proper equipment performance and safety, a maintenance

program must be established. It is the owner’s responsibility to arrange for
this service, and to assure that personnel performing this are fully qualified to
service Gendex dental X-ray equipment.

It is recommended that the Preventative Maintenance checks as listed in the

supplied Installation/Maintenance Manual be performed at the time of
installation and every twelve months thereafter.

Correcting Image Distortions

If, during the operation of your Orthoralix DDE Panoramic device you receive
an image that is visibly distorted (negative, flipped or fragmented), please
follow the instructions below to resend the last patient scanned to your
imaging software. This process can be done without the need to rescan the
patient.
1. In the system tray of the PC, left click on the DDE icon. The Orthoralix DDE
window will appear.

032-0253-EN Rev 3 9-1

Orthoralix 8500 DDE

2. On the following screen, select the “Last Image” tab. On the “Last Image”
screen you will see a “Resend” button. Select the “Resend Button” and
the last image scanned will be resent to the imaging software.

The last scanned image of the patient can be resent to the imaging software
as long as the panoramic machine is not powered down or another patient is
scanned. If the image remains distorted, repeat the above steps. There are no
limitations on the number of times an image can be resent.

If this does not resolve the issue, please contact Gendex Technical Support at
1-800-323-8029.

Proper Patient Positioning

When images are distorted, ensure proper procedures are being employed.

When the patient is correctly positioned, the occlusion plane is slightly

curved. The ascending rami appear nearly parallel.

9-2 032-0253-EN Rev 3

 Problem Prevention and Solutions

Examples of common positioning errors follow.

Problem:
Head turned to
the left

Result: The left side is magnified, the right side is diminished.

Problem:
Head tilted too
far forward

Result: The occlusion plane is very curved, ascending rami sloping

together.

032-0253-EN Rev 3 9-3

Orthoralix 8500 DDE

Problem:
Head tilted too
far backward

Result: The occlusion plane is flat, ascending rami diverging. Often the
hard palate will obscure the upper root apices.

Problem:
Patient standing
too far forward of
cuspid light
beam

Result: The length of the image is shortened and the central incisors are
compressed.

9-4 032-0253-EN Rev 3

 Problem Prevention and Solutions

Problem:
Patient standing
too far back of
cuspid light
beam

Result: The length of the image is expanded and the central teeth are
enlarged.

If image results are still not satisfactory after verifying and correcting
positioning or other procedural errors, the system projection geometry
parameters should be checked. Available for the Orthoralix 8500 DDEDEXpan
is a patented image phantom (part no. 4519-124-20471).

A radiograph taken with this phantom will reveal the exact performance of the
system. This can be taken by yourself or the designated service technician.
The image will also provide information necessary for making any required
adjustments. Instructions for the service technician are found in the
Installation Service Manual supplied with the system.
NOTE: In North America, information and assistance can be obtained by
contacting GENDEX Technical Support (phone number is listed on the
back cover). Otherwise contact your local Gendex representative.

Backup Image Patient Data

It is recommended to routinely duplicate image and patient data 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. The back up
schedule should be determined by the volume of images taken (i.e. daily,
weekly).

032-0253-EN Rev 3 9-5

Orthoralix 8500 DDE

Minimum Hardware Requirements

In order to ensure the proper operation of the Orthoralix 8500 DDE, it is
necessary that the associated computer hardware and software components
are properly selected and installed.

In particular, it is important to correctly configure the connection between the

Orthoralix 8500 DDE and a Personal Computer. In conformance with this, the
other electrically connected parts (Computer and optional peripherals) should
be located outside of the patient area and should be in conformity with IEC
950 and CE 89/336 Directive.

Computer
The computer configuration must include a CD-ROM drive along with Windows
Vista, Windows XP Professional, or Windows 2000 and the configuration as
required by the operating system installed.

Hard Disk
The choice of the hard disk depends on the number and size of the images to
be stored. A hard disk with 80GB or greater is usually able to satisfy a standard
user’s requirements. However, for data security, it is recommended to also
back up the stored information and diagnostic images.

Video Card
If not included in the computer, a S-VGA Video card with 1024x768 mode, and
has at least 4 MB RAM must be installed along with the accompanying
software.

Network Card
An Ethernet 10/100 base T network card must be installed.

Monitor
To ensure correct viewing of the images, a multisync colored monitor with high
resolution capable of displaying 800x600 min., or 1024x768 pixels, is
recommended. A flat screen monitor is preferred. The resolution is related to
the mode selected by the video card. Contrast and brightness must be
properly adjusted.

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 Problem Prevention and Solutions

Errors
In the event of critical or non-critical conditions that would prevent the proper
operation of the equipment, the exposure will be inhibited and an error
message will be displayed on the main control panel (see page 6-1). When a
fault occurs, a “EC” will be displayed in the mA display. The appropriate error
code number will be displayed in the kV display.

If there is an error with the Orthoralix 8500 DDEDEXPan system, the mA

display will show “dE” and the kV display will be blank. Exposure will be
prevented. In this case confirm the network connection, and check the status
icons on the computer system tray. Take any actions indicated. Reset the
system power using the switch at the base of the column. If “dE” is still
displayed after these actions, contact your Gendex service branch.

If “do” is displayed in the mA window, the device is in demo mode. Pressing

the Demo Mode button will return the device to normal operation.

The error codes, type of fault, clearing method, and equipment condition are
listed in the following chart.

Error # Fault Clearing Response

Method

1 Premature release of Exposure switch Any button Terminate exposure

2 Overhead assembly not in home Any button Prevent exposure

position

3 Overhead assembly does not move to Any button Prevent exposure

position

4 CAN Bus Fault Timeout Any button Prevent exposure

5 CAN Bus Fault Ack Error Any button Prevent exposure

6 CAN Bus Fault Command Error Any button Prevent exposure

7 Control Panel Fault Power Reset Prevent exposure

8 Expose Switch Fault Any button Prevent exposure

9 HV Amps Error Any button Prevent exposure

10 Filament Watts Error Any button Prevent exposure

11 Mains Limit Any button

12 CAN Bus Timeout Converter Board Any button

13 kV Upper Error Any button

14 kV Lower Error Any button

032-0253-EN Rev 3 9-7

Orthoralix 8500 DDE

Error # Fault Clearing Response

Method

15 mA Upper Error Any button

16 mA Lower Error Any button

17 No Filament Any button

18 No HV Amps Any button

19-27 Not Used

28 Rom Test Error Power Reset Non-recoverable

Errors

29 Backup Timer Power Reset Non-recoverable

Errors

30 ADC Error Power Reset Non-recoverable

Errors

31 ADC Hang-up Power Reset Non-recoverable

Errors

32 HV Amps HWDR Power Reset Non-recoverable

Errors

33 Converter board Power Reset Non-recoverable

Errors

50 EEPROM read/write Error Power Reset Non Recoverable

Errors

9-8 032-0253-EN Rev 3

 Appendix Technical Data
A

Orthoralix 8500 DDE Tubehead - 110-0184G2

Orthoralix 8500 DDE Column and Imaging Assembly - 110-0234G1, 110-

0234G3

Collimator - 112-1143G1

Power supply 120V AC or 230V AC nominal

Frequency 50-60 Hz

Max. line current rating 8.5A at 230V, 13.5A at 120V for 80kV and 10mA

Nominal line current (idle) stand-by ( 1.1A at 230V, 2.0A at 120V

High voltage waveform true DC, via square-wave output electronic power
converter (50kHz) and voltage multiplier/rectifier

HVDC Power Supply A regulated output switch-mode power supply.

Outputs are independent of line voltage
fluctuation.

60 kV to 80 kV, in 2 kV steps max. tolerance from nominal value ±5%

4 mA to 10 mA, steps 4,6,8,10 max. tolerance from nominal value ±5%

Max. deviation of exposure time + 2%

Tube Type See Product Data Sheet on Installation Manual

Tube Housing See Product Data Sheet on Installation Manual

Duty Factor 1:20

Focal Spot Indicators 3 raised indicators on Tubehead Cover

Output Dose Rate approx. average 1.2 mGy/s at 70 kV, 8 mA,

500 mm.

Leakage radiation from the tubehead: less than 0.25 mGy/ hour at 1 m in any direction

Leakage Technique Factors 80kV at 0.5mAs

Weight 245 lbs., 115 kg

032-0253-EN Rev 3 A-1

Orthoralix 8500 DDE

Environmental Conditions Operational Temperature: +10/+40°C

Storage Temperature: -40/+70 °C
Minimum Air Pressure: 50,000 Pa

Lasers Class 1 2, conforms to IEC

60825-1:2001

Wavelength 650nm

Beam Divergence for >1mrd

Collimated Beam

Pulse Duration 45 s

Maximum Output <1mW

Image Acquisition Device CCD sensor (Charge Coupled Device)

CCD Pixel Size 48 μm

Mains Source Resistance 120 VAC at 0.4 ohms

230 VAC at 1.0 ohms

A-2 032-0253-EN Rev 3

 Appendix Technique Factors
B

Modality: Pan
Preset technique
Total exposure Time factors

Movement range of 

Medium patient (kV)

related to the jaw 

Small patient (kV)

morphology (mm)

Large patient (kV)

Total Cycle Time 

the focal layer, 

Magnification
(seconds)

(seconds)

mA
Standard panoramic 12 24 1.25 0-14 (ref.7) 68 72 76 6

Child panoramic 11 24 1.25 0-14 (ref.7) 62 66 70 6

Lateral TMJ  8 27 1.23 ---------------- 66 70 74 6

(open/close mouth)

Frontal TMJ 6 27 1.64 ---------------- 68 72 76 6

032-0253-EN Rev 3 B-1

Orthoralix 8500 DDE

B-2 032-0253-EN Rev 3

 Appendix X-ray Projection
C Geometries

Standard panoramic Child panoramic

Frontal TMJ Lateral TMJ

(open / close mouth)

032-0253-EN Rev 3 C-1

Orthoralix 8500 DDE

C-2 032-0253-EN Rev 3

 Appendix Manufacturer’s
D Declaration

The Gendex Orthoralix 8500 DDE X-ray systems, classified as Medical

Electrical Equipment, requires special precautions regarding EMC and must
be installed and put into service according to the EMC information provided in
the accompanying product documentation. Portable and mobile RF
communications equipment can effect Medical Electrical Equipment. The
Gendex Orthoralix 8500 DDE complies with EMC requirements when used
with the cables and accessories supplied with the product. The use of
accessories and cables other than those sold by and specified as replacement
parts for internal components, may result in increased emissions or
decreased immunity of the Gendex Orthoralix 8500 DDE. The
Gendex Orthoralix 8500 DDE should not be used adjacent to or stacked with
other equipment. If adjacent or stacked use is necessary, the
Gendex Orthoralix 8500 DDE should be observed to verify normal operation in
the configuration in which it will be used.

032-0253-EN Rev 3 D-1

Orthoralix 8500 DDE

Table 201 - Guidance and manufacturer's declaration - electromagnetic

emissions for all EQUIPMENT and SYSTEMS

Guidance and manufacturer’s declaration –electromagnetic emissions

The Gendex Orthoralix 8500 DDE is intended for use in the electromagnetic environment
specified below. The customer or the user of the Gendex Orthoralix 8500 DDEshould assure
that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions Group 1 The Gendex Orthoralix 8500 DDE uses RF

CISPR 11 energy only for its internal function. Therefore,
its RF emissions are very low and are not likely
to cause any interference in nearby electronic
equipment.

RF emissions Class A The Gendex Orthoralix 8500 DDEis suitable

CISPR 11 for use in all establishments other than
domestic and those directly connected to the
public low-voltage power supply network that
supplies buildings used for domestic
purposes.

Harmonic Class A
emissions
IEC 61000-3-2

Voltage Complies
fluctuations/
flicker emissions
IEC 61000-3-3

D-2 032-0253-EN Rev 3

 Table 204 - Guidance and manufacturer's declaration - electromagnetic
immunity for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING

Guidance and manufacturer’s declaration – electromagnetic immunity

The Gendex Orthoralix 8500 DDE is intended for use in the electromagnetic environment specified
below. The customer or the user of the Gendex Orthoralix 8500 DDE should assure that it is used in
such an environment.

Immunity test IEC 60601 test Compliance Electromagnetic environment - guidance

level level

Portable and mobile RF communications

equipment should be used no closer to any
part of the Gendex Orthoralix 8500 DDE,
including cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of the
transmitter.
Recommended separation distance

d  1,2 P
Conducted RF 3 Vrms 3V
80 MHz to 800 MHz
d  1,2 P
IEC 61000-4-6 
150 kHz to 80 d  2,3 P 800 MHz to 2,5 GHz
MHz

where P is the maximum output power
rating of the transmitter in watts (W)
Radiated RF 3 V/m 3 V/m according to the transmitter
manufacturer and d is the recommended
IEC 61000-4-3 80 MHz to 2,5 separation distance in meters (m).
GHz Field strengths from fixed RF transmitters, as
determined by an electromagnetic site
survey,a should be less than the compliance
level in each frequency range. b
Interference may occur in the vicinity of
equipment marked with following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and landmobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the Gendex Orthoralix 8500 DDE is used exceeds the applicable RF
compliance level above, the Gendex Orthoralix 8500 DDE should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the Gendex Orthoralix 8500 DDE.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m

032-0253-EN Rev 3 D-3

Orthoralix 8500 DDE

Table 206 - Recommended separation distances between portable and mobile

RF communications equipment and the EQUIPMENT or SYSTEM for
EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING

Recommended separation distances between

portable and mobile RF communications equipment and the Gendex Orthoralix 8500 DDE

The Gendex Orthoralix 8500 DDE is intended for use in an electromagnetic environment in
which radiated RF disturbances are controlled. The customer or the user of the
Gendex Orthoralix 8500 DDE can help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF communications equipment
(transmitters) and the Gendex Orthoralix 8500 DDE as recommended below, according to
the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter

Rated maximum m
output power
of transmitter
W

150 kHz to 80 80 MHz to 800 MHz 800 MHz to 2,5 GHz

MHz

0,01 0,12 0,12 0,23

0,1 0,38 0,38 0,73

1 1,2 1,2 2,3

10 3,8 3,8 7,3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in metres (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

D-4 032-0253-EN Rev 3

 Appendix Classification and
E Standards

Classification
Class and Type of Certified equipment: Orthoralix 8500 DDE belongs to the
Class I Type B equipment per IEC 60601-1 – 1990 / A2 - 1995 and Class Ib per
European MDD 93/42/EEC.

Standards
The Orthoralix 8500 DDE complies with the following standards:

General (electrical/mechanical) safety:

• UL 60601-1
• CAN/CSA C22.2 No. 601.1 - M90
• IEC60601-2-32

Radiation protection:
• IEC 60601-1-3 Radiation protection/X-Ray Equipment

Electromagnetic Interference:
• IEC 60601-1-2

Lasers:
• IEC 60825-1

The Orthoralix 8500 DDE Tubehead complies with the following standards:
• IEC60601-2-7
• IEC60601-2-28

The certified components of the Orthoralix 8500 DDE system comply with
Radiation Performance Standards 21 CFR, Subchapter J, at time of
manufacture.

032-0253-EN Rev 3 E-1

Orthoralix 8500 DDE

NOTE: The equipment must only be installed and operated in accordance

with the safety procedures and operating instructions given in the
Installation Manual and in the Operator Manual for the purposes and
applications for which it was designed.

Modifications and/or additions to the equipment may only be carried
out by Gendex or by third parties expressly authorized by Gendex to do
so. Such changes must comply with legal requirements as well as with
the generally accepted technical rules.

It is the responsibility of the user to ensure that existing legal
regulations regarding installation of the equipment with respect to the
building are observed.

This symbol ensures that the product herein described meets the
provisions of UL 60601-1 standard.

The CE symbol ensures that the product herein described meets

the provisions of European Council Directive 93/42 concerning
medical devices.

Mandatory reporting according to the European Directive for 93/42 medical

devices:

In order to fulfil 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 insufficient 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 notified to the manufacturer or his agent, in order to permit the
fulfillment of the obligations foreseen for said manufacturer in the a.m.
European Directive.

Gendex Dental Systems is the manufacturer in accordance with European

Council Directive for medical devices 93/42/EEC.

US federal law restricts this device to sale by or on the order of a dentist.

E-2 032-0253-EN Rev 3

 Installation Manual
Gendex Dental Systems Authorized Representative:
901 West Oakton Street KaVo Dental GmbH
Des Plaines, IL 60018 U.S.A. Bismarckring 39
Tel 1-888-275-5286 88400 Biberach, Germany
Fax 1-847-550-1322 www.gendex-dental.com
www.gendex.com www.kavo.com
 Installation Manual
Manual de instalación
Installationshandbuch
Manuele d’installazione
Manuel d’installation

Installation Manual
Panoramic X-ray System

0413

Gendex Dental Systems Kaltenbach & Voight GmbH

1910 North Penn Road Bismarckring 39
Hatfield, PA 19440 USA D-88400 Biberach, Germany
Customer Service: 1-800-323-8029 Tel: +49 7351 56 0
Fax: 1-847-550-1322 Fax: +49 7351 56 1488
Technical Support: 1-800-769-2909 e-mail: info@kavo.de
Fax: 1-847-718-0716
www.gendex.com

©2011 Gendex Dental Systems, 032-0253-EN Rev 3 2011 April 1