Gendex ORTHORALIX 8500 User manual

Operator Manual
Panoramic X-ray

Operator’s Manual 032-0176-EN Rev. 4
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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 operating the ORTHORALIX® 8500. GENDEX dealers will assist you in placing the ORTHORALIX 8500 in operation.
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.

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Operator’s Manual 032-0176-EN Rev. 4
General 7
Compliance with Applicable Standards 9
Symbols and Labels 11
3.1 Symbols 11
3.2 Location of identication labels 12
Safety 13
Product Description 15
Control Keys and Indicators 17
Preliminary Procedures 19
7.1 Film selection 19
7.2 Darkroom requirements 19
7.3 Film and cassette handling 19
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Table of contents

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General Operating Procedures 21
8.1 Equipment preparation 21
8.2 Program selection 22
Standard Panoramic Program 25
Panoramic Projection Factors 29
Common Positioning Errors 31
11.1 Panoramic image quality 35
Hygienic Procedures and Cleaning 35
12.1 Hygienic procedures 35
12.2 Cleaning procedures 35
System Conguration Program 37
13.1 Pan sensitivity (Film Speed) 37
Error Messages 39
Technical Data 41
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Operator’s Manual 032-0176-EN Rev. 4
Recommended maintenance 43
Manufacturer's Declaration 45
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Operator’s Manual 032-0176-EN Rev. 4
General
This Operator’s Manual is intended to assist the Operator in the safe, and effective operation of the
lm-based ORTHORALIX 8500 high frequency Panoramic X-ray system.
It contains the information necessary to operate the equipment, the technical specications, and
the procedures to perform its simple maintenance.
Before attempting to operate the equipment, read this manual thoroughly. Pay particular attention
to all Warnings and Cautions incorporated in it.
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Operator’s Manual 032-0176-EN Rev. 4
Compliance with
Applicable Standards
Class and Type of Certied equipment: ORTHORALIX 8500 belongs to the Class I Type B equipment
per IEC 60601.1 – 1990 / A2 - 1995 and Class IIb per European MDD 93/42/EEC.
The ORTHORALIX 8500 complies with the following standards:
General (electrical/mechanical) safety:
• UL60601-1FileNumber:E185414
• CAN/CSAC22.2No.601.1-M90
• IEC60601-2-32
• ElectromagneticInterference:IEC60601-1-2:
• Radiationprotection:IEC60601-1-3Radiationprotection/X-RayEquipment
• Lasers:IEC60825-1(2001)
The ORTHORALIX 8500 Tubehead complies with the following standards:
• IEC60601-2-7
• IEC60601-2-28
The certied components of the ORTHORALIX 8500 system comply with Radiation Performance
Standards21CFR,SubchapterJ,attimeofmanufacture.
The equipment must only be installed and operated in accordance with the safety
procedures and operating instructions given in this Operator’s Manual and in the
Installation/ Maintenance Manual for the purposes and applications for which it was
designed.
Modications 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.
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Operator’s Manual 032-0176-EN Rev. 4
Symbols and Labels
3.1 Symbols
The following symbols are used in the equipment and/or in this manual:
Type B: Protection against electric shock (IEC 60601.1 - 1990/A2 - 1995)
Consult written instructions in this Operator’s Manual.
X-Ray generator
This x-ray unit may be dangerous to patient and operator unless safe exposure factors and
operating instructions are observed.
Laser energy present
Mains Hot Wire
Mains Neutral Wire
Earth Ground
Do Not Dispose Of In Trash, Special Recycling Required.
Detailed notes, identied with this symbol
Emergency Stop
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3.2 Location of identication labels

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Safety
In the interest of the safety of patient and user, the following points should be
observed:
Radiation safety
Only qualied and authorized personnel may operate this equipment observing all laws
and regulations concerning Radiation Protection.
The operator at all times must remain 6ft. (2m) from the focal spot and the x-ray beam
for operator protection.
Fullusemustbemadeofallradiationfeaturesontheequipment,andofallradiation
protection devices, accessories, and procedures available to protect the Patient and
Operator from x-ray radiation.
Electrical safety
Covers on the equipment should only be removed by qualied and authorized service
personnel.
This equipment must only be used in rooms or areas that comply with all applicable
laws and recommendations concerning electrical safety in rooms used for medical
purposes,e.g.IEC,USNationalElectricalCode,orotherlocalstandardsconcerning
provisions of an additional protective earth (ground) terminal for equipotential
connection.
This equipment must always be electrically disconnected from the mains electrical
supply before cleaning or disinfecting.
Ordinary medical equipment without protection against ingress of liquids. No water or
any other liquid should be allowed to leak inside the equipment, as they may cause a
short-circuit and corrosion.
Emergency stop
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.
Explosion safety
This equipment must not be used in the presence of ammable or potentially explosive
disinfecting gases or vapors, which could ignite causing personal injury and/or damage
to the equipment. If such disinfectants are used, the vapor must be allowed to disperse
before using the equipment.
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Laser safety
This equipment is designed in accordance with IEC60825-1:2001.
The position of laser sources are emphasized by means of the following warning labels
(black on yellow).
Although compliant to the safety rules, it is a good practice for the
operator to avoid direct exposure of his eyes and patient’s eyes to the LASER beam.
Location of laser aperatures:
Mid-saggital Laser Apperature Mirror
Frankfurt/Cuspid Laser Aperature

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Product Description
The ORTHORALIX 8500 is a system for rotational panoramic radiography of the dento-maxillo-facial
area.
The system consists of:
• Columntobemountedtothewallorwiththeoptionalfreestandingbase
• Motor-drivenoverheadassemblywithcontrolsforpatientpositioning,settingoftechnique
factors and radiographic projection geometry
• Cassettedrivesystemwithatcassettefor15x30cmlm
• X-raytubehead,withDCpowersupplytotheX-raytube
• Remotecontrolboxandhandswitch
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During a panoramic exposure, the X-ray tubehead and sensor holder move around the patient’s
head. 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. Imaging software allows the enhancement and electronic storage of the image. Patient
positioning is simple, accurate, and consistent, by means of positioning lasers, a bite guide and
head stabilizers. During the exposure, the patient remains still while the motorized components
rotate. All movements for the panoramic radiographic projection are performed by independent
motors, which are microprocessor controlled.
Along with the Standard Panoramic mode, the ORTHORALIX 8500 provides a special child
projection, designed to further reduce radiation dosage and conform the image to the child’s
dentition.
Projection programs standard on the ORTHORALIX 8500:
• StandardPanoramic
• ChildPanoramic
Demo mode
Push to toggle between
x-ray inhibited (demo
mode) and normal
mode.
Lamp is lit when in
demo mode

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Control Keys and
Indicators
Main control panel
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Reset
Push to reset system mA display
kV display
kV up
Push to increase
kV in 2 kV
increments
kV down
Push to decrease
kV in 2 kV
decrements
Patient size preset
selector
Push to toggle
through preset
patient size
selections
Child lamp
11 second exposure
Medium adult lamp
12 second exposure
Large adult lamp
12 second exposure
Demo mode
Push to toggle between
x-ray inhibited (demo
mode) and normal
mode.
Lamp is lit when in
demo mode
System ready lamp
System cooling lamp
Operation inhibited by
tubehead cooling cycle
X-ray emission lamp
Small adult lamp
12 second exposure

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Column control panel and emergency stop button
Power-save mode
Push to toggle the unit in and out of power-save
mode
Power on lamp
Reset
Push to reset system
Carriage up
Push to move carriage up; push and hold for fast
positioning
Posterior carriage adjust
Push to move cuspid positioning light beam away
from column
Anterior carriage adjust
Push to move cuspid positioning light beam
towards column
Carriage down
Push to move carriage down; push and hold for fast
positioning
Patient positioning lasers
Push to toggle on and off
Emergency Stop button
Press to stop the scan and turn off the power to all
moving parts.
Turn the button clockwise to reset.

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Preliminary Procedures
7.1 Film selection
The ORTHORALIX 8500 is supplied with a 15x30 cm panoramic lm cassette loaded with a Kodak
Lanex Regular intensifying screen. The recommended lm for use with this screen is Kodak T- Mat G
lm (PAN/TMG15).
A starter pack of lm is provided for calibration and demonstration purposes. It is strongly
recommended that a supply of fresh lm is obtained prior to taking lms for diagnostic purposes.
Additional lm is available from your GENDEX dealer.
Note: In general, mixing lm and screens from different brands is not advisable. In
particular, blue lms must not be used with green screens. If any other than the
recommended lm and/or screen is used, refer to the Conguration section to properly
program the equipment settings.However, for data security, it is recommended to also back
up the stored information and diagnostic images.
7.2 Darkroom requirements
Forgoodimagequality,itisalsoessentialtoensurethefollowing:
• Makesurethatthedarkroomiscompletelylight-proof,andthatapropersafelight(Kodak
GBX-2, Kodak LED or equivalent) is used.
• Ifanautomaticprocessorisused,thelmprocessormustbeproperlymaintainedaccording
to the manufacturer’s instructions and replenished daily if not done automatically.
• Thelevelofchemicalsmustbecheckeddaily.
Chemicals must be replaced after the appropriate time interval (depending on the number of lms
processed), following the manufacturer’s instructions.
7.3 Film and cassette handling
The cassette must be loaded and unloaded in an absolutely light-tight darkroom or in a suitable
daylight loader for the lm processor. Lift the lever on the side to open the cassette.
To load a new lm, open the lm box and carefully remove one sheet of lm. Place it into the
cassette. Close and latch the cassette and place in a safe location awaiting use. The loaded cassette
is then ready to be slid into the cassette holder on the equipment.
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To minimize static electricity and other artifacts, the lm should be handled only by the edges. Care
should be taken to keep the screens and lm clean. The lm should be stored in a cool, dry location.
The lm box should be stored vertically to avoid pressure artifacts from objects being placed on
top of the lm box. The x-ray lm must not be used after the expiration date indicated on the lm
package.