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
Installation Manual
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.

-iii032-0246-EN Rev 2
Chapter 1 - Introduction and Technical Data
Copyright ........................................................................................................... 1-1
Pre-Installation ................................................................................................... 1-1
Location Considerations .............................................................................................1-1
Electrical Installation Requirements ............................................................................1-3
Recommended Computer Configuration ......................................................................1-4
Technical Data .................................................................................................... 1-5
Approximate Shipping Size and Weight ......................................................................1-5
Environmental Limitations Certification ......................................................................1-5
Chapter 2 - Safety Items
Important Safety Information ............................................................................. 2-1
Warnings, Cautions, and Notes ...................................................................................2-1
Safety Precautions ......................................................................................................2-2
Electrical Fire Hazard ..................................................................................................2-2
Explosion Hazard ........................................................................................................2-3
Mechanical Hazards ...................................................................................................2-4
Laser Beam Hazards ...................................................................................................2-4
Radiation Safety .........................................................................................................2-5
Radiation Protection Measures ...................................................................................2-5
Location of Identification Labels ......................................................................... 2-6
System Labels .................................................................................................... 2-8
Compliance with Applicable Standards ............................................................. 2-10
Chapter 3 - Installation
Unpacking .......................................................................................................... 3-1
Column Wall Mounting ........................................................................................ 3-3
Free Standing Mounting ..................................................................................... 3-6
Completing Installation ...................................................................................... 3-9
Electrical Power Connection .............................................................................. 3-11
230V AC Mains Installation .......................................................................................3-11
120V AC Power Cord Installation ...............................................................................3-12
CCD Sensor Installation .................................................................................... 3-13
Completing the Install ...................................................................................... 3-16
Table of Contents

Table of Contents
032-0246-EN Rev 2-iv
Chapter 4 - Software Installation
Recommended Computer Configuration .............................................................. 4-1
GxPicture Install Procedures ............................................................................... 4-2
Chapter 5 - System Configuration
Chapter 6 - CCD Sensor Calibration
Icon Status ......................................................................................................... 6-3
Chapter 7 - Alignment and Adjustments
Beam Alignment Test .......................................................................................... 7-1
Beam Adjustment .......................................................................................................7-4
Adjust mA Setting ............................................................................................... 7-6
Check Laser Positioning ...................................................................................... 7-7
Cover Installation ............................................................................................... 7-9
Sites with Multiple Computers ............................................................................ 7-9
Set Sound Volume ............................................................................................ 7-10
Parameter Adjustments .................................................................................... 7-11
GxPicture Parameter Adjustments GUI Interface ........................................................7-11
Imaging Viewers ............................................................................................... 7-12
VixWin Platinum Imaging Viewer ...............................................................................7-12
Dentrix Imaging Viewer .............................................................................................7-14
DEXIS Imaging Viewer ...............................................................................................7-17
Practice Works Imaging Viewer .................................................................................7-19
Chapter 8 - Acceptance
Electrical System Checks .................................................................................... 8-1
Line Voltage Regulation Check ....................................................................................8-1
Dead Man Check ................................................................................................. 8-1
Performance Verification ..................................................................................... 8-2
Exposure Light and Alarm Check ......................................................................... 8-2
Chapter 9 - Troubleshooting
Error Codes ......................................................................................................... 9-2
Troubleshooting Method .................................................................................... 9-4
Chapter 10 - Electrical Block Diagrams and PCB Layouts
Chapter 11 - Tubehead and Insert Specifications
Panoramic X-ray Tube Housing (Tubehead) ........................................................ 11-1
Tubehead Specifications ...........................................................................................11-1
Insert ............................................................................................................... 11-3
Introduction ..............................................................................................................11-3
Physical Characteristics ............................................................................................11-4
Thermal Characteristics ............................................................................................11-4

Table of Contents
-v032-0246-EN Rev 2
Electrical Characteristics ...........................................................................................11-4
Insert Components ...................................................................................................11-5
Appendix A - Centering Test
Magnification Factor Correction .......................................................................... A-2
Verify Alignment of X-ray Field ....................................................................................A-4
Appendix B - Annual Maintenance
Maintenance List ................................................................................................ B-1
Appendix C - Advanced Image Parameter Adjustments
Third Party Viewer ...............................................................................................C-1
Adjust Third Party Viewers ..........................................................................................C-3
Example of Image Presentation .................................................................................C-10

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1-11-1
032-0246-EN Rev 2
Chapter
1Introduction and Technical
Data
Copyright
Documentation, Orthoralix 8500 DDE, and the operating software are copyrighted with all rights
reserved. Under the copyright laws, this documentation may not be copied, photocopied,
reproduced, translated, or reduced to any electronic medium or machine readable form in
whole or part, without the prior written permission of Gendex Dental Systems. Gendex and
Orthoralix are registered trademarks of Gendex.
Pre-Installation
The 8500 DDE is designed to mount to a wall with wooden studs on 16” centers, with adequate
support (see below). Alternately, it can be mounted to a normal masonry wall or on the optional
free-standing base plate.
NOTE: Verifying the wall support capability is the responsibility of the installer.
Location Considerations
•The device should have a minimum area of 92” (234 cm) high by 50
1/2” (128.4 cm) deep and 40” (102 cm) wide. Access for operator
and patient should be considered according to the plan below. The
device is mounted 6.5” (165 cm) from the wall, using the furnished
wall brackets. Wall bracket location and column base plate mounting
do not apply when the optional free standing base is used.
•The device is operated from the right side of the equipment. It is
recommended that a minimum of 34”(86 cm) from the center line of
the column is allowed on the right side of stand for operator access.
•Each wall bracket support bolt must withstand 120 lbs (54.4 kg) of
shear load and 400 lbs (181.4 kg) of withdrawal force. Bolts are
supplied with the device for mounting into wood studs. Fasteners for
mounting to other structures must be supplied by the installer. No
external support is necessary with optional free standing base. Floor
must be able to support a weight of approximately 250 lbs (113 kg)
wall mounted device or 375 lbs (170 kg) free standing Orthoralix
8500 DDE, plus patient and operator.

Orthoralix 8500 DDE Installation Manual
032-0246-EN Rev 21-2
70.00
1778
2327.90
91.65
50.56
1284.27
49.87
1266.70
39.25
996.95
37.11
942.61
6.50
164.98
Typical electrical box location
Typical network connection location
[164.98]
6-1/2
39-1/4
[996.95]
50-5/8
[1284.27]
37-1/8
[942.61]
49-7/8
[1266.70]
70
[1778]
91-5/8
[2327.90]

Introduction and Technical Data
1-3032-0246-EN Rev 2
Electrical Installation Requirements
•Power supply: 230V AC or 120V AC nominal
•Frequency: 50-60 Hz
•Max. line voltage regulation at 115V: 4% voltage drop max. during
exposure.
•Max. line current rating: 8.5A at 230V, 13.5A at 115V.
•Nominal line current (idle) stand-by (at 230V): 1.1A (approximately)
•Nominal line current (idle) stand-by (at 120V): 2.0A (approximately)
•Mains source resistance:
NOTE: Consult local electrical codes for further information. The circuit
should be on a separate fuse or circuit breaker, rated at a minimum of
20A. No other load should be operated on the circuit. Conduit from
electrical service distribution center to junction box or wall outlet to
contain: Power “hot” wire, power wire neutral and ground wire.
•#12 wire-- up to 100 ft (30m)
•#10 wire-- 100 ft (30m) to 150 ft (46m)
This device is designed to be connected to 120V AC nearby outlet using an
appropriately rated line cord. For convenience, a suitable cord is included for
connection to North American outlets only. The line cord connection does not
meet international EMC requirements for medical devices.
For mains supplies greater than 120V AC nominal, the device must be hard-
wired to ensure compliance with all applicable international safety standards.
Voltage Range (VAC) Max. Line Resistance (OHM)
120 0.4 Max
230 1.0 Max

Orthoralix 8500 DDE Installation Manual
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Recommended Computer Configuration
GxPicture 2.7.2 or later, VixWin Platinum 1.2 or later (if applicable) is required, and
is to run on the following recommended hardware configuration(s):
PCs using Windows XP Professional, and Windows 2003:
•300 MHz 32-bit (x86)
•512 MBB of system memory
•40 GB hard drive with at least 1.5 GB of available space
•CD-ROM or DVD driver
•Support for DirectX 9 graphics with:
•WDDM Driver
•128 MB of graphics memory (minimum)
•32 bits per pixel
PCs using Windows Vista Business:
•1 GHz 32-bit (x86)
•1 GB of system memory
•40 GB hard drive with at least 15 GB of available space
•CD-ROM or DVD driver
•Support for DirectX 9 graphics with:
•WDDM Driver
•128 MB of graphics memory (minimum)
•Pixel Shader 2.0 in hardware
•32 bits per pixel
PCs shall provide USB and Serial Com Port connectivity and shall support TCP/
IP connectivity.

Introduction and Technical Data
1-5032-0246-EN Rev 2
Technical Data
Approximate Shipping Size and Weight
The Orthoralix 8500 DDE System ships in one container, 70 “ (1.78 m) long,
36” (86 cm) wide and 48” (1.22 m) tall, that is designed to fit into a normal
installer’s van. The approximate shipping weight is 190 kg (420 lb).
Environmental Limitations Certification
The certified components of the system comply with U.S. Radiation
Performance Standards 21 CFR, Subchapter J, at time of manufacture. The CE
symbol ensures that the product herein specified, and manufactured from the
year 1997 onwards, meets the provisions of the European Council Directive
89/336/EEC relating to electromagnetic compatibility, and European Council
Directive 93/42/EEC concerning medical devices.
Cooling and duty rating specifications apply at altitudes up to 12,000 ft
(3657 m), average relative humidity not exceeding 95 percent, and maximum
ambient temperature not exceeding 80°F (26.6°C).
Shipping and storage: From -40 to 70°C (-40 to 158°F), 95% maximum relative
humidity.
Operating: From 10 - 40°C (50 - 104°F), 95% non-condensing @ 25°C (77°F)
maximum humidity.

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2-12-1
032-0246-EN Rev 2
Chapter
2Safety Items
Important Safety Information
This device is designed to meet stringent safety standards. However, to maintain the safety of
operators and patients, you must operate the equipment correctly and properly and ensure the
equipment is properly maintained.
It is essential to follow all safety instructions, warnings, and cautions specified in this manual
to ensure the safety of patients and operators. In addition, read and observe all danger and
safety labelling on the system.
Warnings, Cautions, and Notes
Before attempting to operate the equipment, it is recommended that you read
this manual thoroughly including all cautions and warnings. This guide uses
the following conventions to describe situations that are potential hazards to
the patient or operator, potential loss of data, or potential damage to the
equipment.
WARNING
Warnings are intended to alert the user that failure to follow the procedure
could cause fatal or serious injury to the user, patient, or any other person, or
result in a misdiagnosis.
CAUTION
Cautions are intended to alert the user that failure to follow the procedure
could cause damage to the equipment or cause loss of data.
ADVISORY: Advisories are used to define information for the operator
regarding advice towards use of the device or process.
NOTE: Notes are used to highlight important or unusual points to be brought
to the attention of the operator.

Orthoralix 8500 DDE Installation Manual
032-0246-EN Rev 22-2
Safety Precautions
WARNING
The X-ray device may be dangerous to the patient and operator if you do not
observe and follow the safe exposure factors and operating instructions. Do
not operate this system unless you have received training to perform a
procedure.
WARNING
Do not remove covers or cables on system. High voltage is present in the
system. To avoid personal injury from electrical shock, do not operate the
system with any covers open or cables removed.
WARNING
Keep hands and other body parts clear of identified pinch points.
Electrical Fire Hazard
Do not place any liquid or food on any part of the consoles or other modules
of the system.
Observe all fire regulations. Fire extinguishers should be provided for both
electrical and non-electrical fires. All operators should be fully trained in the
use of fire extinguishers and other fire-fighting equipment and in local fire
procedures.
WARNING
In the event of an electrical fire, only use extinguishers that are labelled for
that purpose. Using water or other liquids on an electrical fire can lead to fatal
or other serious personal injury.
Covers on the equipment should only be removed by qualified 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 equipment potential connection.

Safety Items
2-3032-0246-EN Rev 2
WARNING
This equipment must always be electrically disconnected from the mains
electrical supply before cleaning or disinfecting. Avoid 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.
WARNING
In the event of an electrical fire, to reduce the risk of electrical shock, try to
isolate the equipment from the electric source before attempting to
extinguish the fire.
Cabling Requirements
System cabling connections must be installed away from walkways and
doorways. It is recommended to run cabling along wall perimeters. If there is
a chance of mechanical damage due to the cable location, then the use of
conduit or other means of protection should be considered.
Explosion Hazard
Do not use the System in the presence of explosive gases or vapors, including
anaesthetic gases. Use of this system in an environment for which it is not
designed can lead to fire or explosion.
WARNING
Do not use flammable or potentially explosive disinfecting sprays on or near
the system. The vapor created by the spray could ignite causing fatal or other
serious personal injury and/or damage to equipment.
If hazardous substances are detected while the system is turned on, do not
attempt to turn off the system. Evacuate the area and then remove the hazards
before turning off the system.

Orthoralix 8500 DDE Installation Manual
032-0246-EN Rev 22-4
Mechanical Hazards
WARNING
Do not operate the system with any covers open or removed. Operating the
system with open or removed covers could expose mechanical operating
systems that could cause serious or fatal personal injury to you or the patient.
Only qualified and authorized service personnel should remove covers from
the system.
Carefully observe the patient during the scanning procedure to ensure that
when the system gantry moves, the patient does not collide with the gantry or
other equipment. Ensure that the patient does not grab or hold any part of the
system or nearby equipment.
Laser Beam Hazards
This equipment is designed in accordance with IEC60825-1:2001.
WARNING
Laser beams can cause optical damage. Instruct the patient to close eyes to
avoid looking into the beam. The use of optical instruments such as
eyeglasses with large diopter or mirrors, increase eye hazard with this
product.
WARNING
The System has laser markers to assist you in planning scan procedures. If
you are using the laser markers, warn the patient that the laser beam could be
harmful. Advise the patient that laser beams can cause optical damage.
Instruct the patient not to stare at the laser beam and to avoid looking into the
beam.
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.

Safety Items
2-5032-0246-EN Rev 2
Radiation Safety
X-rays are dangerous to both operator and others in the vicinity unless
established safe exposure procedures are strictly observed. Use the following
safety measures to ensure safety to the patient and operator.
The useful and scattered beams can produce serious bodily injuries to
patients and persons in the surrounding area if used by an unskilled operator.
Adequate precautions must always be taken to avoid or reduce exposure to
the useful beam or to scattered radiation.
Operators are strongly urged to comply with the current recommendations of
the International Commission on Radiological Protection and, in the United
States, the US National Council for Radiological Protection.
Only qualified 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.
Radiation Protection Measures
Use the following measures to protect yourself and the patient from
unintended exposure to radiation. The physician is responsible for protecting
the patient from unnecessary radiation. Anyone who is near the patient during
test procedures must observe the following precautions:
•Maintain adequate distance from exposed radiation source.
•Keep exposure times to a minimum.
•Wear protective clothing (lead apron, etc.) to protect the anatomical
areas.
•Wear a PEN dosimeter and/or film badge.
•If you are required in the exam room during a procedure, stay as far
from the device as possible or behind a mobile protective wall.

Orthoralix 8500 DDE Installation Manual
032-0246-EN Rev 22-6
Location of Identification Labels
ATTENTIONRAYONS - X
CAUTIONX-RAYS
OPERATIONSEULEMEMENTPAR
DUPERSONNELAUTORISE.VOIR
MANUELDEL’OPERATEUR.
TOBEOPERATED ONLYBY
AUTHORIZEDPERSONNEL.SEE
OPERATOR’SINSTRUCTIONS.
- THIS X-RAYUNIT MAY
BEDANGEROUSTO PATIENTAND
OPERATORUNLESSSAFE
EXPOSUREFACTORSAND
OPERATINGINSTRUCTIONSARE
OBSERVED.
WARNING
LASERRADIATION
DO NOT STARE IN TO BEAM
CAUTION
Complie s with FDA perfo rmance stan dards for
laser productsexcept for deviations pursuant
toL aser Notice No. 50, dated June 24, 2007
Wavelength:650nm,output Power≤1mW
CLASS II LASER PRODUCT
LASER RADIATION
DO NOT STARE IN TO BEAM
CAUTION
Complie s with FDA perfo rmance stan dards for
laser productsexcept for deviations pursuant
toL aser Notice No. 50, dated June 24, 2007
Wavelength:650nm,output 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.
WARNI NG - THIS X-RAY UNIT MAY
BE DANGEROUS TO PATIENTAND
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: Productcomplies with
FDA performa nce standards for
radiat ion and laser produc ts exc ept
for devi ations pursuant to Lase r
Notice No. 50, dated 24 June 2007
E-Stop
Not on all models

Safety Items
2-7032-0246-EN Rev 2
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.
WARNING - THIS X-RAY UNIT MAY
BE DANGEROUS TO PATIENT AND
OPERATOR UNLESS SAFE
EXPOSURE FACTORS,
OPERATING INSTRUCTIONS AND
MAINTENANCE SCHEDULES ARE
OBSERVED.

Orthoralix 8500 DDE Installation Manual
032-0246-EN Rev 22-8
System Labels
The following labels are attached to the system.
Laser Aperture
CAUTION
LASER RADIATION
DO NOT STARE INTO BEAM
Wavelength: 650nm, output
Power less than or equal to 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
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