Gendex ORTHORALIX 8500DDE User manual

Panoramic X-ray System
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
UserManual
Installation Manual

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.

-iii032-0253-EN Rev 3
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
Table of Contents

032-0253-EN Rev 3-iv
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

-v032-0253-EN Rev 3
Orthoralix 8500 DDE
Appendix D - Manufacturer’s Declaration
Appendix E - Classification and Standards
Classification .......................................................................................................E-1
Standards ............................................................................................................E-1

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

1-1032-0253-EN Rev 3
Chapter
1About this Manual
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.

Orthoralix 8500 DDE
032-0253-EN Rev 31-2
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.

1-3032-0253-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.

Orthoralix 8500 DDE
032-0253-EN Rev 31-4

2-1032-0253-EN Rev 3
Chapter
2System Description
The Orthoralix 8500 DDE connected to a computer comprises the system.
Major Components
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.
ATTENTIONRAYONS - X
CAUTIONX-RAYS
OPERATIONSEULEMEMENTPAR
DUPERSONNELAUTORISE. VOIR
MANUELDEL’OPERATEUR.
TOBEOPERATEDONLY BY
AUTHORIZEDPERSONNEL.SEE
OPERATOR’SINSTRUCTIONS.
- THIS X-RAY UNITMAY
BEDANGEROUSTO PATIENTAND
OPERATORUNLESSSAFE
EXPOSUREFACTORSAND
OPERATINGINSTRUCTIONSARE
OBSERVED.
WARNING
1
2
3
6
5
7
1. Rotating imaging assembly
2. Column
3. Column control panel
4. Emergency stop
(not on all models)
5. Main control panel
6. Pan CCD sensor
7. X-ray generator assembly
8. Exposure handswitch
9. Remote exposure switch
(may not be installed)
8
4

Orthoralix 8500 DDE
032-0253-EN Rev 32-2
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
1
2
3

2-3032-0253-EN Rev 3
System Description
Labels - Location and Descriptions
ATTENTIONRAYONS - X
CAUTIONX-RAYS
OPERATIONSEULEMEMENTPAR
DUPERSONNELAUTORISE.VOIR
MANUELDEL’OPERATEUR.
TOBEOPERATEDONLY BY
AUTHORIZEDPERSONNEL.SEE
OPERATOR’SINSTRUCTIONS.
-THIS X-RAYUNITMAY
BEDANGEROUSTO PATIENTAND
OPERATORUNLESSSAFE
EXPOSUREFACTORSAND
OPERATINGINSTRUCTIONSARE
OBSERVED.
WARNING
LASER RADIATION
DO NOT STARE IN TO BEAM
CAUTION
Complies with FDAp erformance standards for
laserproducts except for deviations pursuant
toLase r Notice No. 50, dated June 24, 2007
Wavelengt h: 650nm, ou tput Power ≤1mW
CLASS II LASER PRODUCT
LASER RADIATION
DO NOT STARE IN TO BEAM
CAUTION
Complies with FDAp erformance standards for
laserproducts except for deviations pursuant
toLase r Notice No. 50, dated June 24, 2007
Wavelengt h: 650nm, ou tput Power ≤1mW
CLASS II LASER PRODUCT
Des Plaines, IL USA
Gendex Dental Systems
Label No. 408-0343
0.4 IEC 60336 2.5 Al/85 IEC 60522
GENDEX GX 85-15
REF
SN
SN
Certication: Product complies with radiation performance
standards under the Federal Food, Drug, and Cosmetic act.
Certication - Complies with FDA radiation
performance standards 21 CFR, sub chapter J.
Gendex Dental Systems
Panoramic X-Ray Beam Limiter
112-1143G1
SN
REF
11-1234567DP Des Plaines, IL USA
09 - 2009
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,
OPERATING INSTRUCTIONS AND
MAINTENANCE SCHEDULES ARE
OBSERVED.
Des Plaines, IL USA
Gendex Dental Systems
LabelNo.408-0349
120V 50/60 Hz 1620VA
2.0A ; 13.5A
230V 50/60 Hz 1955VA
1.1A ; 8.5A
REF
Medical Equipment
CLASSIFIED UL60601-1, IEC60601-1
& CAN/CSA-C22.2 No. 601.1-M90
IEC60825-1:2001
34SL
CLASS 1
TYPE B
Certication: Product complies with
FDAperformance standards for
radiation and laser prod uctsexc ept
for deviations pursuant to Laser
Notice No. 50, dated 24 June 2007
E-Stop
Not on all models

Orthoralix 8500 DDE
032-0253-EN Rev 32-4
Label Description
Check Jumper
Position the jumper for the input
voltage being used. This tag must
be removed before reassembling
cover.
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
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.
J9 J8 J10 J9 J8 J10
120V 230V
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.
Input voltage being used.
Before reassembling cover.
Position the jumper for the
This tag must be removed
de La tension de réseau utilisée.
Cette étiquette doit être retirée avant de replacer le couvercle.
Placez le pont en fonction
Posizionare il ponticello per la tensione di rete appropriata.
Questa etichetta deve essere rimossa prima di richiudere
La copertura.
408-0390P1
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.
WARNIN G - THIS X-RAY UNIT MAY
BE DANGEROUS TO PATIENT AND
OPERATOR UNLESS SAFE
EXPOSURE FACTORS,
OPERATING INSTRUCTIONS AND
MAINTENANCE SCHEDULES ARE
OBSERVED.

2-5032-0253-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.

Orthoralix 8500 DDE
032-0253-EN Rev 32-6
Do not connect phone to the connector.
Earth Ground
Mains Hot Wire
Mains Neutral Wire
Emergency Stop
(not on all models)
Symbol Description

3-1032-0253-EN Rev 3
Chapter
3Safety
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.

Orthoralix 8500 DDE
032-0253-EN Rev 33-2
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.

3-3032-0253-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.

Orthoralix 8500 DDE
032-0253-EN Rev 33-4
Anatomical Reference Indications
It is strongly recommended to pay attention to the Land Rletters 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.
LASERRADIATION
DO NOT STARE INTO BE AM
CAUTION
Complieswith FDA performance standards for
laserproducts except for deviations pursuant
toLaser Notice No. 50, dated June 24, 2007
Wavelength: 650 nm, output Pow er ≤1mW
CLASSII LASER PRODUCT
LASERRADIATION
DO NOT STARE INTO BE AM
CAUTION
Complieswith FDA performance standards for
laserproducts except for deviations pursuant
toLa ser Notice N o. 50, date d June 24, 200 7
Wavelength: 650 nm, output Pow er ≤1mW
CLASSII LASER PRODUCT
Midsagittal plane laser
2 lasers:
Frankfurt plane laser
Cuspid laser