User manual

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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.
Orthoralix® 8500
Table of contents
1
2
3
4
5
General
3
Compliance with applicable standards
5
2.1
Marking...........................................................................................................................................................................................6
2.2
Classification .................................................................................................................................................................................6
Explanation of symbols
7
Location of identification labels
9
Safety
5.1
6
7
8
User Manual
11
Laser aperture locations ........................................................................................................................................................ 12
Product description
13
Control keys and indicators
15
7.1
Main control panel................................................................................................................................................................... 15
7.2
Column control panel............................................................................................................................................................. 16
Preliminary procedures
17
8.1
Film selection............................................................................................................................................................................. 17
8.2
Dark room requirements ...................................................................................................................................................... 17
8.3
Film and cassette handling .................................................................................................................................................. 18
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9
10
11
12
General operating procedures
19
9.1
Equipment preparation ......................................................................................................................................................... 19
9.2
Program selection .................................................................................................................................................................... 20
Standard panoramic program
23
Panoramic projection factors
27
Common Positioning Errors
29
12.1 Panoramic film quality............................................................................................................................................................ 32
13
Hygienic procedures and cleaning
33
13.1 Hygienic procedures ............................................................................................................................................................... 33
13.2 Cleaning procedures............................................................................................................................................................... 33
14
System configuration program
35
14.1 Pan sensitivity (Film Speed).................................................................................................................................................. 35
15
16
17
User Manual
Error messages
37
Technical data
39
Recommended maintenance
41
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1
General
This Operator’s Manual is intended to assist the Operator in the safe, and effective operation of the filmbased ORTHORALIX 8500 high frequency Panoramic X-ray system. Information for the use of the direct digital
ORTHORALIX 8500 DDE will be found in the separate ORTHORALIX 8500 DDE User Manual.
It contains the information necessary to operate the equipment, the technical specifications, 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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2
Compliance with applicable
standards
The ORTHORALIX 8500 complies with the following standards:
International applicable standards
General Safety
IEC/EN 60601-1
UL60601-1
CAN/CSA C22.2 No. 601.1-M90
General requirements for safety
Amendment No. 1
Amendment No.2
Medical Electrical Equipment - General Requirements for safety
Medical Electrical Equipment, Part 1: General Requirements for Safety
1988
1991
1995
2000
System Compatibility
IEC/EN 60601-1-1
Safety requirements for medical electrical systems
2000
Electromagnetic Compatibility
IEC/EN 60601-1-2
Electromagnetic compatibility: requirements and tests
2001
Radiation Protection
IEC/EN 60601-1-3
1994
Radiation protection in diagnostic X-equipment
Programmable Medical Systems Requirements
IEC/EN 60601-1-4
Programmable electrical medical system
1996
Particular Requirements
IEC/EN 60601-2-7
IEC/EN 60601-2-28
Safety of high voltage generators of diagnostic X-ray generators
Safety of X-ray tube assemblies for medical diagnosis
1998
1993
Laser Safety
IEC/EN 60825-1
Safety of Laser Products
2001
National compulsory standards
EU
93/42
European directive concerning Medical devices
US
FDA
CDRH regulations (USA), CFR 21 par. 1020.30 & 31.
1993
CANADA
Canadian NHW regulations (R.E.D. Act).
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2.1
Marking
The CE symbol ensures that the product herein described meets the provisions of European Council
Directive 93/42 concerning medical devices.
This symol ensoures ensures that the product herein described meets the provisions of UL 60601-1
standard
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 fulfilment of the obligations foreseen for said manufacturer in the a.m. European Directive.
ORTHORALIX 8500 system and its certified components comply with Radiation Performance Standards 21 CFR,
Subchapter J, at time of manufacture.
The original language of this manual is English.
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.
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.
2.2
Classification
Medical device classification
EU
93/42 Class II b
US
FDA Class II
IEC
IEC/EN 60601-1 Class I Type B
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Explanation of symbols
Type B: Protection against electric shock (IEC 60601.1 – 1990 / A2 - 1995)
Consult written Instructions in this Operator’s Manual
Attention Rayons-x
Operation seulement par du personal; autorise.
Warning X-Ray
This x-ray unit may be dangerous to patient and operator unless safe exposure
factors and operating instructions are observed.
Laser energy present
L
N
Mains Hot wire
Mains Neutral wire
Earth Ground
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Location of identification
labels
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Safety
Radiation safety
Only qualified and authorized personnel may operate this equipment, observing all laws
and regulations concerning Radiation Protection.
During all X-Ray emission events, the operator must, for protection, remain a minimum of
6ft. (2m) from the focal spot and the x-ray beam.
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 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 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 shortcircuit and corrosion.
Explosion safety
This equipment must not be used in the presence of flammable 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 the device is 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.
5.1
Laser aperture locations
Mid-Saggital
Laser Aperture
Mirror
Frankfort/Cuspid
Laser Aperture
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Product description
6
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 flat cassette for 15 x 30 cm film.
• 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 cassette holder move around the patient’s head. The
beam from the x-ray tube is collimated by a slit diaphragm. The flat film cassette passes behind a secondary
collimator, which blocks the radiation scattered from the patient. 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
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Control keys and indicators
7.1
Main control panel
mA display
Reset
Push to reset system
kV display
Demo mode
Push to toggle between x-ray
inhibited (demo mode) and
normal mode.
Lamp is lit when in demo mode
kV up
Push to increase kV in 2 kV
increments
System ready lamp
kV down
Push to decrease kV in 2 kV
decrements
System cooling lamp
Operation inhibited by
tubehead cooling cycle
Patient size preset selector
Push to toggle through preset
patient size selections
X-ray emission lamp
Child lamp
11 second exposure
Small adult lamp
12 second exposure
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Medium adult lamp
12 second exposure
15
Large adult lamp
12 second exposure
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7.2
Column control panel
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
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Preliminary procedures
8.1
8
Film selection
The ORTHORALIX 8500 is supplied with a 15x30 cm panoramic film cassette loaded with a Kodak Lanex Regular intensifying screen. The recommended film for use with this screen is Kodak T- Mat G film (PAN/TMG15).
A starter pack of film is provided for calibration and demonstration purposes. It is strongly recommended that
a supply of fresh film is obtained prior to taking films for diagnostic purposes. Additional film is available from
your GENDEX dealer.
Note: In general, mixing film and screens from different brands is not advisable. In particular, blue films
must not be used with green screens. If any other than the recommended film and/or screen is used, refer
to the Configuration section to properly program the equipment settings.
8.2
Dark room 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 film 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 films processed),
following the manufacturer’s instructions.
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8.3
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 film processor. Lift the lever on the side to open the cassette.
To load a new film, open the film box and carefully remove one sheet of film. 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.
To minimize static electricity and other artifacts, the film should be handled only by the edges. Care should be
taken to keep the screens and film clean. The film should be stored in a cool, dry location. The film box should
be stored vertically to avoid pressure artifacts from objects being placed on top of the film box. The x-ray film
must not be used after the expiration date indicated on the film package.
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General operating procedures
9.1
9
Equipment preparation
Turn the system on by means of the power on/off switch located on the floor portion of the mounting fixture, at
the base of the column. The “power on” lamp on the column control panel will light up, as will a lamp for patient
size currently selected and the mA and kV displays.
Note: It is neither necessary nor advisable to turn the unit off between use by means of the power on/off
switch. The unit has a built-in “sleep” mode, which will shut the system down after approximately 30 minutes to minimize power use.
power switch
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Press the reset key. If during its reset routine the machine finds no internal abnormalities, the red “ready” lamp
will be lit.
Ready light
Note: Before the patient is positioned, all metal articles such as glasses, removable dentures and earrings
must be removed. If a lead apron is used, make sure that the neck is not covered. Otherwise, artifacts and
unexposed areas will appear on the radiograph.
9.2
Program selection
Note: When the system is turned on, it will default to medium patient size selection.
Patient size selection
This is done via patient size key to scroll to the proper patient size. The light under the patient size icon will
indicate the selection of:
Patient size selection key
• pedo, (i.e. a child),
• small, (i.e. a small young lady or teenager),
• medium, (i.e. average size female or male),
• large, (i.e. large adult male or elderly person with calcified mandible).
Pressing the Patient Size Selection Key will progressively move through the selections. Once the light below the
appropriate setting is lit, the appropriate exposure technique factors (kV, mA) for that Patient Size will be set.
Patient size indicators
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The kV can also be individually adjusted via the up and down keys in the middle part of the control panel.
Increasing kV manually from the pre-programmed value will result in an increase in film blackening with a
decrease in the contrast. Note that the indicator light will move to the appropriate adult size icon as the kV is
manually adjusted.
The panoramic exposure time is solely determined by the panoramic exposure modality chosen (i.e., adult or
child). You can always reset the default technique factors by pressing the relevant patient size key
Demo run
To execute a demo run (a no-radiation simulation) of the panoramic operation, press the demo mode switch on
the main control panel. The demo mode lamp next to the button will light. At this time, pressing the exposure
switch will allow the system to operate without X-rays to demonstrate system functions.
Demo mode key
Equipment reset
Pressing the reset key returns the unit to the starting position. Pressing the key while the unit is in ready mode
will take the unit out of ready mode.
Reset key
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Standard panoramic program
10
The Standard Panoramic Program is the most common, general purpose exposure modality. With this projection modality, the entire dental and alveolar region as well as the rami and the Temporo-Mandibular Joint (TMJ)
are shown on a single radiograph. The child projection, selected when the “child” size preset is lit, reduces the
exposed length of the film to minimize the radiation of unnecessary portions of a child’s anatomy. On larger
children, the anatomy shown on the radiograph may be confined to the dentition and alveolar region
1.Ensure that the unit is switched on (see page 19). Insert a cassette with a new unexposed film into the cassette
carriage.
2.Press the reset key on the main control panel. The tubehead will move to the proper start position, if it isn’t
already there, and the ready lamp will light.
3.Gently grasp the head support arms at the base of each and spread them open until they are maintained at
the full-open position by the detent. Place a fresh disposable bite guide into the receptacle in the chin rest
support.
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4.Select the proper patient size by pressing the patient size preset key. The light under the selected patient size
symbol will light, indicating:
• pedo, (i.e., a child)
• small, (i.e., a small young lady or teenager)
• medium, (i.e average size female or male)
• large, (i.e. adult male or elderly person with calcified mandible).
This will select and display the appropriate exposure technique factors (kV, mA) for the patient size selected.
Note: Selecting the child preset shortens the exposure time and shortens the image to cover the dentition
only.
The kV can also be individually adjusted via the kV up and down keys on the main control panel. The exposure
time (technique factor) is solely determined by the panoramic exposure modality chosen. You can always revert
to the default technique factors by pressing the relevant patient size key.
5.Move the overhead carriage to the proper height for the patient by pressing the up or down buttons on
the column control panel. Pressing the button in and holding will activate the higher speed for faster travel.
Releasing the button and pressing for short “bursts” will allow for precise positioning at the slower motor
speed. Raise the carriage up or down so that the chin rest is at the level of the patient’s chin. The procedure
is essentially the same for patients in wheelchairs. For very tall patients it may be necessary to position them
in a seated position.
• Have the patient stand as straight as possible and carefully move into the unit and bite on the bite guide.
For partially edentulous patients, a cotton roll may be used to fill in for missing incisors. Completely
edentulous patients may close their lips over the bite guide notch. Although the Orthoralix 8500 uses a
proprietary software algorithm to compensate for the shadow cast by the spine into the radiograph, the
patient must be encouraged not to slouch. Have the patient grasp the handles on either side for stability.
Having the patient step forward slightly will assist in minimizing the spinal shadow.
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6.Turn on the positioning laser lights by pressing the key on the column control panel. Note: The lasers are
timed to go out automatically after 45 seconds. If necessary, pressing the key again will turn them back on.
The lasers will only function in the ready mode.
• Check that the front vertical light beam is centered on the patient’s mid-sagittal plane. Gently turn the
patient’s head to align the mid-sagittal plane with the vertical laser beam.
• Note the parallel horizontal beams projected on the side of the patient’s face. Press the carriage up or
carriage down buttons on the column control panel to raise or lower the patient’s chin until an imaginary
line connecting the tragus of the ear and the lower margin of the orbit of the eye is aligned parallel to the
laser beam stripes. This will establish the patient’s Frankfort plane parallel to the floor.
• The vertical cuspid laser beam indicates the location of the focal trough in the anterior region during the
exposure. To ensure that the lateral incisors are placed into the center of the focal trough, the lateral laser
beam must be centered on the cuspid. If it does not, use the posterior and anterior carriage adjust buttons
on the column control panel to move the carriage as necessary to align the laser on the cuspid.
• Although the unit is compliant to safety requirements, it is a good practice for the operator to avoid
exposure of his and the patient’s eyes to the laser beams; the position of laser sources are emphasized by
mean of warning labels and illustrated in Section 5 of this document.
Caution - Use of controls or adjustments or the performance of procedures other than those
specified in this manual may result in hazardous laser radiation exposure.
7.Gently close the head support arms. Slight spring tension will maintain light pressure on the patient to stabilize him.
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8.Verify that the ready light is lit and that the proper patient size or technique factor is selected.
• Just prior to exposure, instruct the patient to place their tongue flat on the roof of their mouth, close their
lips around the bite guide, swallow and hold still during the exposure.
• Move to a safe location at least 6ft. (2m) from the x-ray generator and press and hold the exposure handswitch.
• The exposure switch must be kept firmly pressed during the whole exposure procedure; otherwise the
x-ray emission and movements will be stopped (“dead man” exposure mode). If this happens, the machine
must be reset, and the cassette reloaded before repositioning the patient.
• During the exposure an audible tone will be emitted and the amber x-ray light will be lit on the main
control panel.
• When the exposure is terminated, open the head support arms and help the patient carefully step out of
the unit. Remove the film cassette for film developing and press the reset key to prepare the unit for the
next patient.
Caution - Use of controls or adjustments or the performance of procedures other than those
specified in this manual may result in hazardous radiation exposure.
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Panoramic projection factors
Specifications of the Standard Projection modality program:
• Total Exposure time:
12 s (11 s for child mode)
• Total Cycle time:
25 s
• Magnification:
1.25
• Default kV factor:
66 kV pedo patient,
68 kV small patient,
72 kV medium size patient,
78 kV large size patient.
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Common Positioning Errors
Correct position
The occlusion plane is slightly curved, ascending rami nearly parallel.
Incorrect position
Head turned to left: the left side is magnified, the right side is diminished.
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Incorrect position
Head tilted too far forward:
The occlusion plane is very curved, ascending rami sloping together.
Incorrect position
Head tilted backward:
The occlusion plane is flat, ascending rami diverging. Often the hard palate will obscure the upper root apices.
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Incorrect position
Vertical light beam shifted backward:
The length of the image is shortened and the central incisors are compressed.
Incorrect position
Vertical light beam shifted forward:
The length of the image is expanded and the central teeth are enlarged.
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12.1
Panoramic film quality
Note: 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 is
a patented universal test phantom (part no. 112-1173G1). 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.
In North America, additional information and assistance can be obtained by contacting GENDEX Technical Support at (800) 769-2909. Otherwise contact your local Gendex representative.
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Hygienic procedures
and cleaning
13.1
13
Hygienic procedures
The bite guides supplied with your Orthoralix 8500 are disposable and not designed to be reused from patient
to patient. To use, remove and unwrap a tray of 25 bite guides from the box. The tray fits into the drawer on
the front of the unit. Place a fresh bite guide into the patient head positioner prior to positioning the patient.
After the procedure, discard the used bite guide. Note: The bite guides are not designed to be steam, dry heat,
or chemically sterilized.
• Additional bite guides can be supplied by your GENDEX dealer. Disposable bite guides - #E0218A (pkg. of 100)
13.2
Cleaning procedures
Always disconnect the equipment from the electrical power supply before cleaning or disinfecting. No water or
any other liquid must be allowed to enter the equipment, as this will cause short-circuits and corrosion.
All the equipment including accessories and connecting cables should be cleaned or disinfected only by
wiping with a damp cloth, followed by rubbing down with a dry cloth. Do not use solvents (toluene, benzine,
etc.), corrosive cleaning agents or abrasive polishing materials. Spray disinfectants are not recommended as
the disinfectants may enter the equipment and cause short circuits or corrosion. If sprays are unavoidable, the
following precautions must be taken: If the room in which the equipment is installed is to be disinfected by
means of an atomizer, the equipment should be carefully covered with a plastic sheet. The equipment should
be switched off and allowed to cool down well in advance in order to prevent convection currents drawing
the disinfectant mist into the equipment. After dispersal of the disinfectant mist, the plastic sheeting can be
removed and the equipment returned to use. The equipment may not be used in the presence of disinfectants
which vaporize to form explosive mixtures, and the vapor must be allowed to disperse before the equipment is
returned to use. The method of disinfection used should comply with current regulations and recommendations,
including those concerning the prevention of explosive hazards.
Be sure to reconnect the equipment to electrical power supply after cleaning.
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System configuration program
14
The displayed mA parameter of the ORTHORALIX 8500 is configured at the factory for the supplied film and
screen combination. This setting is reconfigured via internal switches and can be changed by your local Gendex
dealer at the time of installation or at a later date.
14.1
Pan sensitivity (Film Speed)
The film and screen combination provided by the factory result in a speed of 400, corresponding to 8mA. If you
wish to use a different film, screen, or combination, the mA value may need to be changed to accommodate
the resulting film speed. The mA setting can also be changed for personal preference of overall darker or lighter
images.
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Error messages
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 15). 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.
Note: If a film cassette is not in place, the mA display will show “FC” and the kV display will be blank. Exposure will be prevented.
The error codes, type of fault, clearing method and equipment condition are listed in the following chart.
Error #
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19-27
28
29
30
31
32
33
User Manual
Fault
Premature release of Expose. switch
Overhead assembly not in home position
Overhead assembly does not move to position
CAN Bus Fault Time out
CAN Bus Fault Ack error
CAN Bus Fault Command error
Key board Fault
Expose Switch Fault
HV Amps Error
Filament Watts Error
Mains Limit
Can Bus Time out Converter board
kV Upper error
kV Lower error
mA Upper error
mA lower error
No Filament
No HV Amps
Not Used
Rom Test Error
Backup Timer
ADC Error
ADC Hang up
HV AMPS HWDR
uncontrolled
37
Clearing Method
Any key
Any key
Any key
Any key
Any key
Any key
Power Reset
Any key
Any key
Any key
Any key
Any key
Any key
Any key
Any key
Any key
Any key
Any key
Response
Terminate Exposure
Prevent Exposure
Prevent Exposure
Prevent Exposure
Prevent Exposure
Prevent Exposure
Prevent Exposure
Prevent Exposure
Prevent Exposure
Prevent Exposure
Power Reset
Power Reset
Power Reset
Power Reset
Power Reset
Power Reset
Non Recoverable Errors
Non Recoverable Errors
Non Recoverable Errors
Non Recoverable Errors
Non Recoverable Errors
Non Recoverable Errors
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Orthoralix® 8500
User Manual
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16
Technical data
ORTHORALIX 8500 TUBEHEAD 110-0184G2
ORTHORALIX 8500 COLUMN AND IMAGING ASSEMBLY 110-0199G1, 110-01999G3
COLLIMATOR 112-1143G1
User Manual
Power supply:
120V AC or 230 V AC nominal,
Frequency:
50-60Hz
Max. line voltage regulation at 120V:
4% voltage drop max. during exposure.
Max. line current rating:
8.5A at 230V, 13.5A at 120V for 80kV and 10mA.
Nominal line current (idle) stand-by
by (at 230V)1.1A approx. (at 120V):
2.0A approx
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%
Exposure Time:
12 sec. standard
11 sec. pedo
Tube type:
See Product Data Sheet on Installation Manual
Tube housing:
See Product Data Sheet 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:
80 kV, .78mA,
Weight:
245 lbs, 115 kg
Environmental conditions:
Operational temperature +10/+40 °C
Storage temperature -40/+70 °C
Minimum air pressure 50,000 Pa
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Orthoralix® 8500
Lasers:
Mains source resistance
User Manual
- Class
2, conforms to IEC 60825-1:2001
- Wavelength
650nm
- Beam divergence for collimated beam
>1mrd
- Pulse duration
45 seconds
- Maximum output
<1mW
Voltage range (VAC)
Max. line resistance (ohm)
120
0.4 Max
230
1.0 Max
40
Doc # P8500UMF - Rev. 0 - 1 June 2005
Recommended maintenance
17
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 of the supplied Service Manual be
performed at the time of installation and every twelve months thereafter.
In North America, for clarification or additional information, contact GENDEX Technical Support at (800) 769-2909
User Manual
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User Manual
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User Manual
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User Manual
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