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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.
Gendex Orthoralix 8500 ® Table of contents General Compliance with Applicable Standards Symbols and Labels 3.1 Symbols 3.2 Location of identification labels Safety Product Description Control Keys and Indicators Preliminary Procedures 7.1 Film selection 7.2 Darkroom requirements 7.3 Film and cassette handling Operator’s Manual...
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Gendex Orthoralix 8500 ® General Operating Procedures 8.1 Equipment preparation 8.2 Program selection Standard Panoramic Program Panoramic Projection Factors Common Positioning Errors 11.1 Panoramic image quality Hygienic Procedures and Cleaning 12.1 Hygienic procedures 12.2 Cleaning procedures System Configuration Program 13.1 Pan sensitivity (Film Speed)
General This Operator’s Manual is intended to assist the Operator in the safe, and effective operation of the film-based ORTHORALIX 8500 high frequency Panoramic X-ray system. It contains the information necessary to operate the equipment, the technical specifications, and the procedures to perform its simple maintenance.
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Compliance with Applicable Standards Class and Type of Certified 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...
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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.
Safety In the interest of the safety of patient and user, the following points should be observed: Radiation safety 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.
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Gendex Orthoralix 8500 ® 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.
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 flat cassette for 15x30 cm film • X-ray tubehead, with DC power supply to the X-ray tube • Remote control box and handswitch Operator’s Manual 032-0176-EN Rev. 4...
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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.
Control Keys and Indicators Main control panel Reset mA display Push to reset system kV display Demo mode Push to toggle between kV up x-ray inhibited (demo mode) and normal Push to increase mode. kV in 2 kV Lamp is lit when in increments demo mode kV down...
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Gendex Orthoralix 8500 ® 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...
Preliminary Procedures 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.
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Gendex Orthoralix 8500 ® 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.
General Operating Procedures 8.1 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 lamp for patient size currently selected and the mA and kV displays.
Gendex Orthoralix 8500 ® Press the reset key. If during its homing 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.
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Gendex Orthoralix 8500 ® 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.
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On larger children, the anatomy shown on the radiograph may be confined to the dentition and alveolar region Ensure that the computer/software is activated and that the Orthoralix 8500 is turned on (see page 21).
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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.
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Gendex Orthoralix 8500 ® 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.
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Gendex Orthoralix 8500 ® Verify that the ready light is lit, that the computer controlling the panoramic unit is properly connected (green status icon) 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.
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. Operator’s Manual 032-0176-EN Rev. 4...
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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. Operator’s Manual 032-0176-EN Rev. 4...
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Gendex Orthoralix 8500 ® 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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Gendex Orthoralix 8500 ® 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.
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.
12.1 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.
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System Configuration Program 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.
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If “dE” is still displayed after these actions, contact your Gendex service branch. If “do” is displayed in the mA window, the device is in demo mode. Pressing the Demo Mode button will return the device to normal operation.
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Technical Data ORTHORALIX 8500 TUBEHEAD 110-0184G2 ORTHORALIX 8500 COLUMN AND IMAGING ASSEMBLY 110-0199G1, 110-0199G3 COLLIMATOR 112-1143G1 Power supply 120V AC or 230V AC nominal Frequency 50-60 Hz Max. line voltage regulation at 4% voltage drop max. during exposure 120V 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 2.0A approx.
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It is the owner’s responsibility to arrange for this service, and to assure that personnel performing this are fully qualified to service GENDEX dental x-ray equipment. It is recommended that the Preventative Maintenance checks as listed in the supplied Installation/ Maintenance Manual be performed at the time of installation and every twelve months thereafter.
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Gendex Orthoralix 8500. The Gendex Orthoralix 8500 should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Gendex Orthoralix 8500 should be observed to verify normal operation in the configuration in which it will be used.
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Table 202 - Guidance and manufacturer’s declaration - electromagnetic immunity The Gendex Orthoralix 8500 is intended for use in the electromagnetic environment specified below. The customer or the user of the Gendex Orthoralix 8500 should assure that it is used in such an environment.
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AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Gendex Orthoralix 8500 is used exceeds the applicable RF compliance level above, the Gendex Orthoralix 8500 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re orienting or relocating the Gendex Orthoralix 8500.
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RF communications equipment and the Gendex Orthoralix 8500 The Gendex Orthoralix 8500 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Gendex Orthoralix 8500 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Gendex Orthoralix 8500 as recommended below, according to the maximum output power of the communications equipment.
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