Gendex Orthoralix 8500 DDE User Manual
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Gendex Orthoralix 8500 DDE User Manual

Gendex Orthoralix 8500 DDE User Manual

Panoramic x-ray system
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Al Gulum, DDs, MAGD
February 5, 2025

hi we need help with a part for 8500 ortholax gendex

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1 comments:
Mr. Anderson
February 10, 2025

The needed part for the Gendex Orthoralix 8500 DDE is the "Gendex PA7 4519-101-11201," which is referred to as the "spider board."

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Summary of Contents for Gendex Orthoralix 8500 DDE

  • Page 1 User Manual Panoramic X-ray System...
  • Page 2 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.

  • Page 3: Table Of Contents

    Table of Contents 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) ..............
  • Page 4 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 ....................
  • Page 5 Orthoralix 8500 DDE Appendix D - Manufacturer’s Declaration Appendix E - Classification and Standards Classification .......................E-1 Standards ......................E-1 032-0253-EN Rev 3...
  • Page 6 Orthoralix 8500 DDE 032-0253-EN Rev 3...

  • Page 7: Chapter 1 - About 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. 032-0253-EN Rev 3...

  • Page 8: Intended Use

    Orthoralix 8500 DDE 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.
  • Page 9 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. 032-0253-EN Rev 3...
  • Page 10 Orthoralix 8500 DDE 032-0253-EN Rev 3...

  • Page 11: Chapter 2 - System Description

    System Description Chapter The Orthoralix 8500 DDE connected to a computer comprises the system. Major Components 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.
  • Page 12 Orthoralix 8500 DDE 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.

  • Page 13: Labels - Location And Descriptions

    System Description Labels - Location and Descriptions Gendex Dental Systems Des Plaines, IL USA 120V 50/60 Hz 1620VA 2.0A ; 13.5A 34SL 230V 50/60 Hz 1955VA 1.1A ; 8.5A CLASS 1 TYPE B Cer tific ation: Produc t complies with...
  • Page 14 Orthoralix 8500 DDE Label Description Check Jumper Position the jumper for the input Position the jumper for the voltage being used. This tag must Input voltage being used. This tag must be removed J8 J10 J8 J10 Before reassembling cover.
  • Page 15 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...
  • Page 16 Orthoralix 8500 DDE Symbol Description Do not connect phone to the connector. Earth Ground Mains Hot Wire Mains Neutral Wire Emergency Stop (not on all models) 032-0253-EN Rev 3...

  • Page 17: Chapter 3 - Safety

    Safety Chapter 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.

  • Page 18: Electrical Hazard

    Orthoralix 8500 DDE 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.

  • Page 19: Laser Radiation Hazard

    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.

  • Page 20: Anatomical Reference Indications

    Orthoralix 8500 DDE C A U T I O N 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...

  • Page 21: Proper Disposal Of Electronic Equipment

    Safety Proper Disposal of Electronic Equipment NOTE: The following information is valid in the European Union. If you wish to discard this product, please contact your local authorities or dealer and ask for the correct method of disposal. This symbol on the products and/or accompanying documents means that used electrical and electronic products should not be mixed with general household waste.
  • Page 22 Orthoralix 8500 DDE 032-0253-EN Rev 3...

  • Page 23: Chapter 4 - Cleaning And Disinfection

    Cleaning and Disinfection Chapter Patient Protection All parts coming in direct contact with the patient must be kept clean and disinfected. Always replace the disposable hygienic covers on the bite before positioning a new patient. These covers should be stored in a clean, dry environment and not exposed to direct sunlight or UV radiation.
  • Page 24 Orthoralix 8500 DDE CAUTION It is not recommended to use spray disinfectants as the disinfectants may permeate into the system and cause short circuits or corrosion. If an atomizer is used for disinfection, follow the procedure provided below to protect the system.

  • Page 25: Chapter 5 - System Startup And Shutdown

    System Startup and Chapter Shutdown Turning the System On 1. Turn on the system by pressing the power switch at the base of the column. The POWER ON LED on the column control panel will light up, as will the lamps for the currently selected patient size, the mA display, and the kV display.
  • Page 26 Orthoralix 8500 DDE 2. Ensure that the computer/software is activated. 3. Wait until “dE” is no longer seen in the mA display and press Reset. NOTE: If after pressing the Reset button “dE” remains, there is a connection problem. Refer to Status Icon on page 6-9 to verify the status of the system.

  • Page 27: Turning The System Off

    System Startup and Shutdown Turning the System Off NOTE: It is neither necessary nor advisable to turn the unit off between uses. After approximately 30 minutes of not being used, the unit goes into a power-saving mode. When the system goes into power-save mode, it automatically saves data and system status and then shuts off power to all possible components.
  • Page 28 Orthoralix 8500 DDE 032-0253-EN Rev 3...

  • Page 29: Chapter 6 - Controls And Indicators

    Controls and Indicators Chapter Power Switch Refer to page 5-1 for the location of the power switch. Main Control Panel Each button on the control panel is labeled with a pictogram related to the associated function. The operator does not use more than one button to initiate a given function.
  • Page 30 Orthoralix 8500 DDE Reset system ON - System ready Turn on Demo mode (no X-ray emission) ON Emitting X-rays ON - Operation has been inhibited due to a tubehead cooling cycle. Scroll through projection options starting at Pan (bottom), then Lateral TMJ (middle), and then Frontal TMJ (top).

  • Page 31: Selecting A Projection

    Controls and Indicators Selecting a Projection When the system is turned on, the Standard Pan modality is set and the relevant projection LED lights up. To select a projection, press to toggle through the three choices: Pan Lateral TMJ , and Frontal TMJ .

  • Page 32: Setting Technique Factors

    Orthoralix 8500 DDE Setting Technique Factors The exposure technique factors related to the chosen selection (kV and mA) will be set and displayed. If desired, the kV value can be modified. The mA value can only be viewed. The exposure time is determined by the...

  • Page 33: Demo Mode

    Controls and Indicators Demo Mode CAUTION As the demo mode is usually followed by the actual exposure, remove all metal articles (glasses, removable dentures, earrings, etc.) before positioning the patient.  If he/she is to be fitted with a lead-lined apron for radiation protection, make sure that the neck is not covered, because this will cause unexposed areas in the radiograph.

  • Page 34: Column Control Panel And Emergency Stop Button

    Orthoralix 8500 DDE Column Control Panel and Emergency Stop Button The control panel for the column is mounted directly on the column. ATTENTION RAYONS - X OPERATION SEULEMEMENT PAR DU PERSONNEL AUTORISE. VOIR MANUEL DE L’OPERATEUR. CAUTION X-RAYS TO BE OPERATED ONLY BY AUTHORIZED PERSONNEL.

  • Page 35: Power-Save Mode

    Controls and Indicators Turn OFF power-save mode ON - Power on Reset system Move rotating imaging assembly up Move rotating imaging assembly out (shifts lateral light beam away from column) Move rotating imaging assembly in (shifts lateral light beam towards column) Move rotating imaging assembly down Turn on the lasers...

  • Page 36: Rotating Imaging Assembly Controls

    Orthoralix 8500 DDE Rotating Imaging Assembly Controls When positioning the patient in the machine, use the up and down buttons to move the rotating imaging assembly up or down. Constant pressure for more than 2 seconds will cause either of these buttons to gradually accelerate until the movement is at the maximum speed.

  • Page 37: Exposure Handswitch

    This green and blue icon indicates the correct operation of the Orthoralix 8500 DDEelectronics (including the CCD sensor), the connection between the Orthoralix 8500 DDE and the CCD sensor, and the connection between the Orthoralix 8500 DDE and the computer or networking device.

  • Page 38: Gx Driver Icon

    Yellow X: Computer/networking device connected but does not have control GX Driver Icon When the Gendex driver is installed correctly, the Gx icon is shown in the system tray. Right-click this icon to display a menu for viewing and modifying data and parameters common to all the Gendex imaging system products.

  • Page 39: Chapter 7 - Standard Pan Projection

    • Select the standard Pan projection Next the patient is prepared: • Properly position the patient in the Orthoralix 8500 DDE • Adjust the patient’s head position The exposure is made. NOTE: A quick reference guide indicating the options/actions necessary to perform a standard panoramic exposure is located on the right side of the column near the control panel.
  • Page 40 Orthoralix 8500 DDE 2. Press Reset. The system is in the ready state when the Ready LED is lit. 3. Press the Patient size selection button. There are four patient size selections: • pedo (child) • small (small female or teenager) •...
  • Page 41 NOTE: For an edentulous patient, it is possible to use the supplied transparent chin rest (B). 6. For hygienic reasons, cover the bite block with a disposable bite-guide cover. These have been designed and developed for use with the Orthoralix 8500 DDE system. 032-0253-EN Rev 3...

  • Page 42: Prepare The Patient

    Orthoralix 8500 DDE Prepare the Patient Place Patient into Position NOTE: To help calm a nervous patient (for example, children) use the demo mode to demonstrate the movement of the rotating imaging assembly. (Refer to page 6-5.) 1. Open the head support arms.
  • Page 43 Standard Pan Projection much as possible in order to decrease the artifact shadow that would otherwise be cast into the image. NOTE: It is possible for the patient to stand in a natural and more comfortable position if they cannot hold the above described position (for example, elderly people)....

  • Page 44: Adjust Patient's Head Position

    Orthoralix 8500 DDE Adjust Patient’s Head Position Although the design of the lasers is compliant with the safety regulations regarding lasers, it is good practice for the operator to avoid exposing his/her eyes and the patient’s eyes to the laser beam. Warning labels indicate the position of the laser sources.
  • Page 45 Standard Pan Projection Patient’s Frankfurt plane aligned with these parallel laser beams NOTE: In step 4, the cuspid light beam indicates the front most position that the X-ray focal trough will reach during the exposure. Normally, setting the cuspid light beam at the center of the cuspid aligns the front most position of the focal trough with the roots of the lateral incisors.

  • Page 46: Take Exposure

    Make sure the patient does not shift position during the exposure process. 3. Verify the correct system status icon displays in the system tray: Orthoralix 8500 DDE is ready to capture the images NOTE: The exposure handswitch button must be kept firmly pressed during the entire exposure procedure.
  • Page 47 Standard Pan Projection 4. Observing the applicable radiation safety procedures, take the exposure by pressing and holding the exposure handswitch button. 5. During X-ray emission, preview images are continuously provided for the imaging software to display. For imaging software that provides a preview window, verify the correct image acquisition.
  • Page 48 Orthoralix 8500 DDE 7. Open the head support arms. Ask the patient to move out. 8. Reset the system. To process the final image, refer to the manual for your imaging software. 7-10 032-0253-EN Rev 3...

  • Page 49: Chapter 8 - Other Panoramic Projections

    Other Panoramic Chapter Projections Press the Function button repeatedly to scroll through the set of projections. The lamp turns on for the projection selected (shown below with Lateral TMJ selected). Refer to Appendix B, Technique Factors, for the factory settings for each projection.

  • Page 50: Lateral Exposure Tmj

    Orthoralix 8500 DDE Lateral Exposure TMJ Description This is a projection of the temporo-mandibular joint, both right and left sides where the TMJ is viewed with projections along the major axis of the condyles (sagittal view of the condyle). Similar to a lateral projection, in this projection, the condyle is generally not perpendicular to the mid sagittal plane of the skull.
  • Page 51 Other Panoramic Projections Press the Function button repeatedly to select Lateral TMJ. nsert the supplied white flat Chin Rest and tighten it firmly into position. 6. Ensure the patient’s body is straight and slanted, with the patient hanging slightly from the handgrip. Stretch the spine as much as possible in order to decrease the artifact shadow that would otherwise be cast into the...
  • Page 52 Orthoralix 8500 DDE 7. Place the ear plug end of the TMJ Ruler in the right auditory meatus. 8. Switch on the positioning lasers. NOTE: The lasers are timed and they will switch off automatically  after 45 s. 9. Move the patient’s...

  • Page 53: Frontal Tmj

    Other Panoramic Projections Frontal TMJ Description This radiographic projection permits the assessment of the exact shape of the condyle, with coronal view (for the diagnosis of arthritis). The frontal projection of the Temporo- Mandibular Joint is obtained by means of the so-called Reverse Geometry Projection.
  • Page 54 Orthoralix 8500 DDE 032-0253-EN Rev 3...

  • Page 55: Chapter 9 - Problem Prevention And Solutions

    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.

  • Page 56: Proper Patient Positioning

    If the image remains distorted, repeat the above steps. There are no limitations on the number of times an image can be resent. If this does not resolve the issue, please contact Gendex Technical Support at 1-800-323-8029. Proper Patient Positioning When images are distorted, ensure proper procedures are being employed.
  • Page 57 Problem Prevention and Solutions Examples of common positioning errors follow. Problem: Head turned to the left Result: The left side is magnified, the right side is diminished. Problem: Head tilted too far forward Result: The occlusion plane is very curved, ascending rami sloping together.
  • Page 58 Orthoralix 8500 DDE Problem: Head tilted too far backward Result: The occlusion plane is flat, ascending rami diverging. Often the hard palate will obscure the upper root apices. Problem: Patient standing too far forward of cuspid light beam Result: The length of the image is shortened and the central incisors are compressed.

  • Page 59: Backup Image Patient Data

    Installation Service Manual supplied with the system. NOTE: In North America, information and assistance can be obtained by contacting GENDEX Technical Support (phone number is listed on the back cover). Otherwise contact your local Gendex representative. Backup Image Patient Data It is recommended to routinely duplicate image and patient data on a removable device for a general storage (e.g.

  • Page 60: Minimum Hardware Requirements

    Orthoralix 8500 DDE Minimum Hardware Requirements In order to ensure the proper operation of the Orthoralix 8500 DDE, it is necessary that the associated computer hardware and software components are properly selected and installed. In particular, it is important to correctly configure the connection between the Orthoralix 8500 DDE and a Personal Computer.

  • Page 61: Errors

    Take any actions indicated. Reset the system power using the switch at the base of the column. 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.
  • Page 62 Orthoralix 8500 DDE Error # Fault Clearing Response Method mA Upper Error Any button mA Lower Error Any button No Filament Any button No HV Amps Any button 19-27 Not Used Rom Test Error Power Reset Non-recoverable Errors Backup Timer...

  • Page 63: Appendix A - Technical Data

    Technical Data Appendix Orthoralix 8500 DDE Tubehead - 110-0184G2 Orthoralix 8500 DDE Column and Imaging Assembly - 110-0234G1, 110- 0234G3 Collimator - 112-1143G1 Power supply 120V AC or 230V AC nominal Frequency 50-60 Hz Max. line current rating 8.5A at 230V, 13.5A at 120V for 80kV and 10mA Nominal line current (idle) stand-by ( 1.1A at 230V, 2.0A at 120V...
  • Page 64 Orthoralix 8500 DDE Environmental Conditions Operational Temperature: +10/+40°C Storage Temperature: -40/+70 °C Minimum Air Pressure: 50,000 Pa Lasers Class 1 2, conforms to IEC 60825-1:2001 Wavelength 650nm Beam Divergence for >1mrd Collimated Beam Pulse Duration 45 s Maximum Output <1mW...

  • Page 65: Modality: Pan

    Technique Factors Appendix Modality: Pan Preset technique factors Standard panoramic 1.25 0-14 (ref.7) Child panoramic 1.25 0-14 (ref.7) Lateral TMJ  1.23 ---------------- (open/close mouth) Frontal TMJ 1.64 ---------------- 032-0253-EN Rev 3...
  • Page 66 Orthoralix 8500 DDE 032-0253-EN Rev 3...

  • Page 67: Appendix C - X-Ray Projection Geometries

    X-ray Projection Appendix Geometries Standard panoramic Child panoramic Frontal TMJ Lateral TMJ (open / close mouth) 032-0253-EN Rev 3...
  • Page 68 Orthoralix 8500 DDE 032-0253-EN Rev 3...
  • Page 69 Gendex Orthoralix 8500 DDE. The Gendex Orthoralix 8500 DDE should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Gendex Orthoralix 8500 DDE should be observed to verify normal operation in the configuration in which it will be used.
  • Page 70 EQUIPMENT and SYSTEMS Guidance and manufacturer’s declaration –electromagnetic emissions The Gendex Orthoralix 8500 DDE is intended for use in the electromagnetic environment specified below. The customer or the user of the Gendex Orthoralix 8500 DDEshould assure that it is used in such an environment.
  • Page 71 Guidance and manufacturer’s declaration – electromagnetic immunity The Gendex Orthoralix 8500 DDE is intended for use in the electromagnetic environment specified below. The customer or the user of the Gendex Orthoralix 8500 DDE should assure that it is used in such an environment.
  • Page 72 Recommended separation distances between portable and mobile RF communications equipment and the Gendex Orthoralix 8500 DDE The Gendex Orthoralix 8500 DDE is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the...
  • Page 73 Classification and Appendix Standards Classification Class and Type of Certified equipment: Orthoralix 8500 DDE belongs to the Class I Type B equipment per IEC 60601-1 – 1990 / A2 - 1995 and Class Ib per European MDD 93/42/EEC. Standards The Orthoralix 8500 DDE complies with the following standards: General (electrical/mechanical) safety: •...
  • Page 74  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....
  • Page 76 Hatfield, PA 19440 USA D-88400 Biberach, Germany Customer Service: 1-800-323-8029 Tel: +49 7351 56 0 Fax: 1-847-550-1322 Fax: +49 7351 56 1488 Technical Support: 1-800-769-2909 e-mail: info@kavo.de Fax: 1-847-718-0716 www.gendex.com ©2011 Gendex Dental Systems, 032-0253-EN Rev 3 2011 April 1...

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