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Notice Notice Thank you for purchasing Green 18 (PHT-65LHS) extra-oral imaging system. The primary mission of Green CT is to aid dental professionals in providing excellent care in a safe environment that promotes healing. However, Green CT is not a product name or a brand name. Green 18 (PHT-65LHS) is an advanced digital diagnostic system that incorporates PANO, CEPH (Optional), CBCT, and 3D MODEL Scan imaging capabilities into a single system. This manual describes how to operate the Green 18 (PHT-65LHS) system. It is recommended that you thoroughly familiarize yourself with this manual to make the most effective use of this equipment. Observe all cautions, safety messages, and warnings in this manual. Due to constant technological improvement, the manual may not contain the most updated information and is subject to change without prior notice to the persons concerned. For further information not covered in this manual, please contact us at: VATECH Co., Ltd. Phone: +82-1588-9510 E-mail: [email protected] This document is originally written in English. Green 18 (PHT-65LHS) is referred to as “equipment” in this manual. Manual Name: Green 18 (Model: PHT-65LHS) User Manual Version: 1.50 Publication Date: 2024-01 Document Number: VDH-UM-068(18) Green 18 (Model: PHT-65LHS) User Manual iii Table of Contents Table of Contents Notice iii Table of Contents iv 1. 1 2. 3. 4. 5. Introduction 1.1 Overview ............................................................................................. 1 1.2 Indications for Use .............................................................................. 1 1.3 Intended Purposes .............................................................................. 1 1.4 Intended User Profiles ........................................................................ 2 1.5 Contraindications ................................................................................ 2 General Information 2.1 Manufacturer's Liability ...................................................................... 3 2.2 Owner and Operator's Obligations ...................................................... 3 2.3 Conventions in this Manual ................................................................. 4 2.4 Marks and Symbols ............................................................................. 5 Warnings and Precautions 9 3.1 General Safety Guidelines ................................................................... 9 3.2 Electricity-related Safety Precautions ............................................... 13 3.3 Radiation Safety ................................................................................ 15 3.4 Warnings ........................................................................................... 16 Imaging System Overview 19 4.1 System Components.......................................................................... 19 4.2 Features ............................................................................................ 19 4.3 Imaging System Overview ................................................................ 19 4.4 Standards and Regulations ............................................................... 20 4.5 Operating Principles .......................................................................... 21 4.6 Imaging System Configuration ......................................................... 21 4.7 Equipment Overview ......................................................................... 23 Imaging Software Overview 5.1 iv 3 39 PC Specifications (Recommended) ................................................... 39 Green 18 (Model: PHT-65LHS) User Manual Table of Contents 6. 7. 8. 9. 10. 5.2 EzDent-i ............................................................................................. 40 5.3 Console Software............................................................................... 41 Getting Started 45 6.1 Turning on the Equipment ................................................................. 45 6.2 Running the Image Viewer (EzDent-i) .............................................. 46 Acquiring PANO Images 51 7.1 PANO Imaging Program Overview .................................................... 51 7.2 Setting Exposure Parameters ............................................................ 56 7.3 Patient Positioning ............................................................................ 63 7.4 X-ray Exposure .................................................................................. 76 7.5 Finishing the Scan ............................................................................. 77 7.6 Checking the Captured Images ......................................................... 77 Acquiring CEPH Images (Optional) 78 8.1 CEPH Imaging Program Overview ..................................................... 78 8.2 Setting Exposure Parameters ............................................................ 80 8.3 Patient Positioning ............................................................................ 84 8.4 X-ray Exposure .................................................................................. 94 8.5 Finishing the Scan ............................................................................. 95 8.6 Checking the Captured Images ......................................................... 95 Acquiring CBCT Images 96 9.1 CBCT Imaging Program Overview ..................................................... 96 9.2 Setting Exposure Parameters .......................................................... 100 9.3 Acquiring a Double Scan Image (optional) ...................................... 105 9.4 Patient Positioning .......................................................................... 108 9.5 X-ray Exposure ................................................................................ 119 9.6 Finishing the Scan ........................................................................... 120 9.7 Checking the Captured Images ....................................................... 120 Acquiring 3D MODEL Scan Images 122 10.1 3D MODEL Scan Imaging Program Overview .................................. 122 10.2 Setting Exposure Parameters .......................................................... 123 Green 18 (Model: PHT-65LHS) User Manual v Table of Contents 11. 12. 13. 10.3 MODEL Positioning .......................................................................... 125 10.4 X-ray Exposure ................................................................................ 126 10.5 Checking the Captured Images ....................................................... 127 Troubleshooting 128 11.1 Troubleshooting .............................................................................. 128 11.2 Error Codes...................................................................................... 129 Cleaning and Disinfection 134 12.1 Cleaning .......................................................................................... 135 12.2 Disinfection ..................................................................................... 136 Maintenance 13.1 138 Regular Maintenance ...................................................................... 138 14. Disposing of the Equipment 140 15. Technical Specifications 142 16. vi 15.1 Mechanical Specifications ............................................................... 142 15.2 Technical Specifications .................................................................. 145 15.3 Electrical Specifications .................................................................. 150 15.4 Environmental Specifications .......................................................... 151 Appendices 152 16.1 Recommended X-ray Exposure Tables ............................................ 152 16.2 X-ray Dose Data .............................................................................. 162 16.3 Electromagnetic Compatibility (EMC) Information ......................... 171 16.4 Hand-wrist Image Evaluation References....................................... 176 16.5 Acquiring Images for Pediatric Dental Patients .............................. 180 16.6 Abbreviations .................................................................................. 191 Green 18 (Model: PHT-65LHS) User Manual 1. Introduction Introduction 1.1 Overview ENGLISH 1. Green 18 (PHT-65LHS) is an advanced 4-in-1 digital X-ray imaging system that incorporates PANO, CEPH (Optional), CBCT, and 3D MODEL Scan imaging capabilities into a single system. Green 18 (PHT-65LHS), a digital radiographic imaging system, acquires and processes multi-FOV diagnostic images for dentists. Green 18(PHT-65LHS) is a complete digital X-ray system equipped with imaging viewers, an X-ray generator, and a dedicated SSXI detector. The digital CBCT system is based on a CMOS digital X-ray detector. The CMOS CT detector captures 3D radiographic images of the head, neck, oral surgery, implant, and orthodontic treatment. Green 18 (Model: PHT-65LHS) can also acquire 2D diagnostic image data in conventional panoramic and cephalometric modes. 1.2 Indications for Use Green 18 (Model: PHT-65LHS) is intended to produce panoramic, cephalometric, or 3D digital x-ray images. It provides diagnostic details of the dento-maxillofacial, ENT, sinus, and TMJ for adult and pediatric patients. The system also utilizes carpal images for orthodontic treatment. The device is to be operated by healthcare professionals. 1.3 Intended Purposes ▪ Determination of the extent of lesions, tumors, cysts, etc., which cannot be adequately visualized on plain films ▪ Diagnosis of foreign bodies or displaced roots involving the maxillary sinus ▪ Diagnosis of bone diseases, cysts, etc., affecting the temporomandibular joints ▪ Identifying the relationship of the inferior dental canal to a tooth/lesion that is to be removed ▪ Assessment of fractures on maxilla, mandible, condylar neck, and fractures of teeth where plain film imaging is equivocal ▪ Visualization of the 3D anatomy of the alveolar clefts ▪ Diagnosis of un-erupted teeth impacted teeth and odontomas ▪ Diagnosis of root resorption of teeth ▪ Assessment of cleft palate ▪ Diagnosis of CRS (chronic rhinosinusitis) ▪ Examinations of the airways for measuring the volume and dimensions of air passages Green 18 (Model: PHT-65LHS) User Manual 1 1. Introduction 1.4 ▪ Reconstruction of position, malformations, and fractures of maxilla & mandible bones, nasal bone, and paranasal sinuses as 3D pictures for operational planning and patient education ▪ Planning any surgery where a 3D analysis of the jaw is required ▪ Storing Plaster Casts in 3D data Intended User Profiles Considerations Requirement Description ▪ Licensed dentists or dental hygienists, radiologists, and graduates of relevant bachelor’s degrees (national qualifications) ▪ Education Knowledge ▪ Understanding the treatment and diagnosis of dental disease Understanding the terms and guidance of hardware and software of a diagnostic medical radiation device and recognizing device connection, installation, and operating conditions Language understanding ▪ ▪ Understanding how to use manuals (English / Korean) or Understanding other languages provided ▪ Understanding the objectives and effects of the diagnosis and treatment of dental disease using diagnostic medical radiation devices Understanding the normal operation of diagnostic medical radiation equipment Understanding the contents of the User Manual Experience ▪ ▪ 1.5 Contraindications Do not use this device other than for the intended purpose. There are no other contraindications to it since the technology is at a controllable level in accordance with global standards. 2 Green 18 (Model: PHT-65LHS) User Manual 2. General Information General Information 2.1 Manufacturer's Liability ENGLISH 2. The manufacturers and/or retailers of this X-ray equipment assume responsibility for the safe and normal operation of this product only when: 2.2 ▪ A VATECH-authorized technician has installed the equipment. ▪ The equipment has been installed by all the cautions and conditions required for installation. ▪ The genuine VATECH-approved equipment and components have been used. ▪ A VATECH-authorized agent has performed all maintenance and repairs. ▪ The equipment has been used normally by the User Manual. ▪ The equipment damage or malfunction is not the result of an error on the part of the owner or the operator. Owner and Operator's Obligations ▪ This equipment’s owner must perform constancy tests regularly to ensure patient and operator safety. Local X-ray safety regulations must perform these tests. ▪ This equipment’s owner must perform regular inspection and maintenance of the mechanical and electrical components to ensure safe and consistent operation (IEC 60601-1). ▪ This equipment’s owner must ensure that both inspection and cleaning follow the maintenance schedule outlined in Chapter 14. Maintenance. Green 18 (Model: PHT-65LHS) User Manual 3 2. General Information 2.3 Conventions in this Manual The following symbols are used throughout this manual. Make sure that you fully understand each symbol and follow the instructions accompanied. Please observe all warnings and safety information included in this document to prevent physical injury and/or damage to the equipment. WARNING Indicates information that must be followed with the utmost care. Failure to comply with a warning may result in severe damage to the equipment or physical injury to the operator and/or patient. CAUTION Indicates a situation that demands prompt and careful action, a specific remedy, or emergency attention. IMPORTANT Indicates a situation or action that could potentially cause problems to the equipment and/or its operation. NOTE RADIATION Indicates a possible danger from radiation exposure. SINGLE USE Indicates a component that must be replaced for each new patient. ESD susceptibility 4 Emphasizes valuable information or provides useful tips and hints. Indicates that an item is susceptible to damage from electrostatic discharges. Green 18 (Model: PHT-65LHS) User Manual 2. General Information 2.4 Marks and Symbols Description Location Dangerous voltage Powerboard Warns ESD hazard. MCU board / Board package Protective earth (Ground) Column Off (power: disconnected to the Main Power Switch) Main Power Switch On (power: connected to the Main Power Switch) Main Power Switch Alternate current Label Type B Applied Equipment (IEC 60601-1: Degree of protection against leakage current and/or electric shock: Class 1 equipment) Label Radiation hazard Label Indicates the authorized representative in the European Community. Label The CE symbol indicates that this product complies with the European Directive for Medical Devices 93/42/EEC as amended by 2007/47/EC as a class IIb device. Label UL mark No. E476672 Label Addresses where the equipment was manufactured. Label Green 18 (Model: PHT-65LHS) User Manual ENGLISH Symbols 5 2. General Information Symbols 6 Description Location Indicates that electrical and electronic equipment must not be disposed of as unsorted municipal waste and must be collected separately. Label Indicates that this equipment is classified as a CLASS 1 LASER PRODUCT by IEC 60825-1 ED.3 regulations. Label Indicates the date when the equipment was manufactured. Label Indicates that the user needs to refer to the Instruction Manual. Label Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. Label Indicates the manufacturer's serial number to identify the specific equipment. Label Green 18 (Model: PHT-65LHS) User Manual 2. General Information 2.4.1 Label Locations ENGLISH The label is attached on the right side of the equipment, and it consists of 6 parts, as below. ⑥ For Canada only (with CEPH) ⑥ For Canada only (without CEPH) The design and contents of the labels may be different in some countries due to local regulations and standards. The label image is used to indicate the location only and may not contain the same content of the actual product. Green 18 (Model: PHT-65LHS) User Manual 7 2. General Information No. 1 Green 18 (PHT-65LHS) Main Label 2 CAUTION Label - X-ray / Attention: X-ray on when equipment in operation. 3 X-RAY GENERATOR Label : 1.6 kW Generator 4 CLASS 1 LASER PRODUCT Label 5 Manufacturer Label : The date of manufacture / Serial Number 6 8 Item Device Identifier Label (For Canada only) For Canada, the Model is distinguished by Green 18 SC and Green 18 SP. Green 18 SC: CEPH included Green 18 SP: CEPH not included Green 18 (Model: PHT-65LHS) User Manual 3. Warnings and Precautions Warnings and Precautions ENGLISH 3. Be sure to strictly observe all warnings and safety instructions included in this manual. This X-ray unit may be dangerous to patients and operators unless safe exposure factors, operating instructions, and maintenance schedules are observed. 3.1 General Safety Guidelines Operator qualifications This equipment may only be operated by personnel adequately trained in its operation. To operate this equipment, the operator must: - Have read and understood the User Manual. - Be familiar with the fundamental structure and functions of this equipment. - Be able to recognize the intermittent operation of this equipment and implement appropriate measures to remedy such irregularities. General safety precautions ▪ Follow the instructions specified in this manual to ensure the safety of both the patient and the operator. ▪ The operator must always maintain vocal/visual contact with the patient during the image acquisition. ▪ Do not open or remove the cover panels on this equipment. Always have a trained and authorized service technician to inspect and maintain this equipment. ▪ Do not place any heavy objects on this equipment at any time. ▪ Do not place any objects within this equipment’s field of operation. It may cause property damage. ▪ Do not push or pull the equipment. Overbalance of the equipment may cause the risk of physical injuries or property damage. ▪ The operator must instruct the patient to remain still until the equipment arm has stopped moving and the reset motion is completed. ▪ Observe all local fire regulations. Always keep a fire extinguisher near the equipment. ▪ The equipment operator must be familiar with this equipment’s emergency protocols. Green 18 (Model: PHT-65LHS) User Manual 9 3. Warnings and Precautions ▪ Ensure that this equipment is always kept away from water, moisture, or foreign substances. ▪ If this product is exposed to water, moisture, or a foreign substance, immediately turn off the main power of the equipment and contact your VATECH technical support representative. ▪ If there are signs of oil leakage, immediately cease all equipment operations and contact your VATECH technical support representative. ▪ External equipment intended for connection to signal input, signal output, or other connectors, shall comply with relevant IEC Standard (e.g., IEC 60950 for IT equipment and IEC 60601-1series for medical electrical equipment). ▪ Also, all such combination-system-shall comply with the standard IEC 60601-1 and IEC 60601-1-1 harmonized national standard or the combination. If in doubt, contact a qualified technician or your local representative. ▪ Any person or organization that installs an external door interlock switch is responsible for ensuring that it has a radiation indicator or equivalent alarm system to show the current state. ▪ Any serious incident in relation to the device should be reported to the manufacturer and the competent authority of the member state in which the user and/or patient is established. Ventilation ▪ Do not close the equipment’s ventilation slots in any case. The ventilation obstruction could result in the equipment overheating due to a lack of air circulation. ▪ Do not spray any liquid or disinfectant on this equipment. The penetration of these substances may damage the electrical and mechanical components inside. Use a soft cloth to disinfect the ventilation slots. ▪ Always leave enough space around the PC to allow for proper ventilation. Hygiene ▪ ▪ ▪ 10 Ensure to disconnect the equipment from the power when cleaning its surface. Do not place liquid or spray near the equipment. Direct contact with liquids can cause an electric shock or damage the system. Do not spray cleaners or disinfectants over the equipment to avoid fire. Green 18 (Model: PHT-65LHS) User Manual 3. Warnings and Precautions All movable patient support components (the Bite, the Chinrest, the Temple Supports, and the Ear Rods) can be cleaned using non-alcohol-based solutions. ▪ Clean the Support Handles using non-alcohol-based cleaning solutions before taking photos of the next patient. ▪ Other equipment surfaces, including the Touch Screen, can be cleaned using a soft cloth dampened with a mild cleaning solution. ▪ New hygiene cover must be provided for each new patient to prevent the transmission of communicable diseases. Do not use aerosol or spray cleaning agents directly on the surface of the equipment. Condensation ▪ Extreme fluctuation in temperature may cause condensation to develop inside the equipment. Do not turn on the equipment until it has reached room temperature. Cooling ▪ Allow the proper amount of cooling downtime (for the X-ray tube to cool down) before acquiring the next image. - - Mode of operation: non-continuous operation (NFPA 70: long time operation) - needs waiting time (at least 60 times the exposure time) before the next exposure begins. Column operation time: Max. 2 min. On / 18 min. Off (Ratio 1:9) ▪ If the temperature inside the tube head reaches 60 °C (140 °F), X-ray exposure will cease, and an error message will be displayed. Normal X-ray capabilities will resume after the generator reaches 58 °C (136.4 °F). ▪ If the fan (optional) is installed, it automatically operates when the temperature surrounding the tube head reaches the pre-defined level: 40 °C (104 °F). The setpoint temperature is configurable. Turning the equipment on / Adjusting the height of the equipment ▪ Do not position the patient near the equipment while it is initiating, as the patient could be injured if the equipment malfunctions. ▪ Ensure that the patient is kept clear of the equipment while adjusting its height. Green 18 (Model: PHT-65LHS) User Manual 11 ENGLISH ▪ 3. Warnings and Precautions Emergency stop ▪ If a problem occurs during image acquisition, press the red Emergency Stop Switch to immediately stop all moving parts and cut off all power to the equipment. (Emergency Stop Switch is located under the bottom of the Vertical Frame. Turn the switch in the direction of the arrow to reboot the equipment.) Trouble-free operation ▪ Never use this equipment in an environment that is susceptible to explosion. ▪ Always operate the equipment within a temperature range of 10 °C to 35 °C (50 °F to 95 °F) for safe operation. Image quality may deteriorate if the equipment is operated outside of this range. ▪ Always allow the equipment enough time to warm up (while switched on) if exposed to temperatures below 10 °C (50 °F). ▪ Only perform X-rays of patients if the system is in full working order. ▪ Always ensure that equipment movement is not obstructed by the patient’s clothing, a medical device (such as a wheelchair), or the patient. ▪ Do not leave the patient unattended around the equipment. ▪ Remove all radio-controlled devices, mobile phones, etc., from the X-ray room before image acquisition as these objects may cause the equipment to malfunction. Modifying the equipment 12 ▪ Modifying the equipment in any way which may affect the safety of the operator, patients, or other persons is prohibited by law. ▪ No part of this equipment is serviceable by the operator. A VATECH qualified service technician must perform all maintenance and repair of this equipment. ▪ This product may only be operated with original VATECH accessories or thirdparty accessories expressly approved by VATECH. Green 18 (Model: PHT-65LHS) User Manual 3. Warnings and Precautions 3.2 Electricity-related Safety Precautions ENGLISH Connect the equipment to the power outlet with protective earth (PE) connection to avoid electric shock. ▪ Check the status of the power source, PC, and cables before operating the equipment. ▪ Ensure that Main Power Switch is set off when the equipment is not in use. ▪ Always disconnect the power supply before cleaning the equipment. ▪ Always keep electrical cords away from hot appliances or radiators. ▪ DO NOT place the PC or peripheral equipment connected to the PC near the patient. ▪ The equipment and PC should be connected to a common protective earth. ▪ Never overload the equipment’s circuit by sharing it with too many appliances. ▪ Use the same power circuit for the PC and the equipment. Combining this equipment with other devices ▪ Do not connect this equipment to devices that are not designated as a part of the system. ▪ Do not connect this equipment to a Multiple Portable Socket-Outlet (MPSO) or extension cord, which is not provided with the equipment. Electromagnetic compatibility ▪ This X-ray equipment complies with IEC standard 60601-1-2. ▪ Medical electrical equipment is subject to special Electromagnetic Compatibility (EMC) preventive measures. It must be installed and operated as specified in EMC information. ▪ If high-voltage, radio link, or MRI systems are located within 5 m of the unit, please observe the specifications stated in the installation requirements. ▪ Portable Radio Frequency (RF) communications equipment may interfere with medical electrical equipment. Therefore, mobile wireless phones in medical offices or hospital environments must be prohibited. ▪ For more details, refer to 16.3 Electromagnetic Compatibility (EMC) Information. ▪ Please also observe the Electro-Static Discharge (ESD) protective measures described. Green 18 (Model: PHT-65LHS) User Manual 13 3. Warnings and Precautions Static Discharge ▪ Without ESD protective measures, connector pins or sockets bearing ESD warning labels must not be touched or interconnected. Electrostatic discharge (ESD) ESD protective measures include 14 ▪ Procedures for preventing electrostatic charge build-up (e.g., temperature control, humidification, conductive floor coverings, and non-synthetic clothing) ▪ Electrostatic discharge of your own body with the frame of the equipment, the protective ground wire, or large metallic objects ▪ Use of the wristband for grounding Green 18 (Model: PHT-65LHS) User Manual 3. Warnings and Precautions 3.3 Radiation Safety ▪ This equipment must be housed inside an X-ray shielded room. ▪ The operator must remain outside a shielded room during X-ray exposure to protect himself/herself from radiation. ▪ During imaging, the operator must maintain vocal/visual contact with the patient from outside the shielded area. ▪ The operator should continuously check the status of the patient and the equipment during imaging. ▪ The operator should be at least 2 m (6 feet) away from the equipment during imaging. ▪ The operator must immediately stop imaging if the equipment malfunctions. ▪ During X-ray exposure, the patient must wear a lead apron with neck and thyroid protection. ▪ Children and pregnant women must consult with a doctor before X-ray exposure. As a manufacturer of radiology equipment that conforms to stringent protection standards worldwide, we guarantee the maximum degree of protection against radiation hazards for our equipment. Green 18 (Model: PHT-65LHS) User Manual 15 ENGLISH Since rules and regulations concerning radiation safety differ between countries, it is the responsibility of the owner and operator of this equipment to comply with all applicable rules and regulations concerning radiation safety and protection in his/her area. 3. Warnings and Precautions 3.4 Warnings The following warning statements must be obeyed with the utmost care. Failure to follow these warnings may cause severe damage to the equipment or physical injuries to the patient and the operator. ▪ ▪ ▪ ▪ ▪ ▪ ▪ 16 X-ray equipment is hazardous to the patient and the operator if proper exposure safety measures and operating instructions are not observed. It is essential to read this User Manual carefully and strictly abide by all warnings and cautions stated. The 3D image should not be used for screening examinations. Each exam must be justified by demonstrating that the benefits outweigh the risk. Where it is likely that evaluation of soft tissues will be required as part of the patient’s radiological assessment, conventional medical CT or MR should be used instead of dental cone beam imaging. Like other medical equipment, Green 18 (PHT-65LHS) system uses high-frequency electrical signals that can interfere with implantable devices such as pacemakers and Implantable Cardioverter Defibrillators (ICDs). If the patient has such an implantable device, you should be aware of any interference in its operation and immediately power off the Dental X-ray system. Green 18 (PHT-65LHS) system is designed to withstand the effects of defibrillation. However, disconnect the Dental X-ray system during defibrillation since a malfunction of the safety controls could otherwise result in electrical burns for the patient. Federal law restricts this device to sale by or on the order of a dentist or with the descriptive designation of any other practitioner licensed by the law of the State in which he practices using or order the use of the device. Green 18 (Model: PHT-65LHS) User Manual 3. Warnings and Precautions Lasers The system incorporates Class 1 laser products. The light localizers used in this product are intended for correct patient positioning and must not be used for any other purpose. ▪ Advise the patient not to look directly at the laser beam for safety. ▪ While adjusting the patient, ensure that the laser beam is not directed at the patient’s eyes. ▪ Wavelength: 650 nm, Radiant power: Max. 039 mW Risk of eye injury! Do not use this equipment with any other laser sources, and do not make any changes to the settings or processes described in these operating instructions. Cleaning ▪ Never expose this equipment to liquids, mist, or sprays. Exposing this equipment to liquids may cause an electric shock or otherwise damage the system. ▪ Do not use spray cleaners on this equipment, as this could cause a fire. During the Operation ▪ Never use this equipment in an environment that is susceptible to explosion. ▪ Do not place flammable materials near this equipment. ▪ Do not use the PC while the equipment is operating. Failure to comply with this instruction may result in system malfunction. ▪ Immediately stop imaging if the equipment malfunctions in any way. ▪ If a problem occurs during imaging, press the red Emergency Stop Switch to immediately stop all moving parts and cut off all power to the equipment’s electrical components. ▪ Never touch the patient while he or she is touching the SIP/SOP connectors. ▪ The medical electrical equipment or medical electrical system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the medical electrical equipment or medical electrical system should be observed to verify normal operation in the configuration in which it will be used. ▪ The use of accessories and cables other than those specified, except cables sold by VATECH of the medical electrical equipment or medical electrical system as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY EQUIPMENT or SYSTEM. Green 18 (Model: PHT-65LHS) User Manual 17 ENGLISH ▪ 3. Warnings and Precautions In case of an electrical fire ▪ Use only fire extinguishers designed for electrical fires to extinguish fires on this equipment. ▪ Liquid extinguishers, such as those which use water, could damage the equipment and cause physical injury. ▪ Unplug the equipment’s power cable before extinguishing any fire. Installation ▪ To avoid improperly balanced equipment, install the device on a flat surface to maintain stability. ▪ If the equipment is not stable, property damage and personal injury may occur. ▪ Do not push or pull the equipment. ▪ Only an authorized technician should install the equipment, complying with proper installation procedures. For further details on installation, refer to the Green 18 (PHT-65LHS) Installation Manual. Security Capabilities 3.4.1 ▪ It is recommended to install and operate EzDent-i under a secure operating environment that allows only authorized users to access a system network equipped with Windows built-in firewall, Windows Defender antispyware tools, and other commonly used 3rd party security tools and application systems. ▪ It is recommended to update the latest version of anti-virus software and firewall. ▪ The software can be updated by the manufacturer only. Unauthorized software updates through a third party, not the manufacturer, is strictly prohibited. Please contact the manufacturer for cybersecurity issues related to the software and medical devices. Side Effects ▪ 18 X-ray imaging exam should be performed only after carefully considering the patient’s health needs. The operator must understand the well-known risks which can occur during X-ray exposure and minimize them by preventing unnecessary radiation exposure for patients. Green 18 (Model: PHT-65LHS) User Manual 4. Imaging System Overview Imaging System Overview 4.1 System Components 4.2 4.3 ENGLISH 4. ▪ Green 18 (PHT-65LHS) X-ray equipment ▪ PC system ▪ Console Software: PANO, CEPH (Optional), CBCT, and 3D MODEL Scan ▪ EzDent-i: 2D viewer and patient management software ▪ Ez3D-i: 3D viewer software Features ▪ Multi-FOV support: Selectable FOV among Double Scan(Optional), 18x10, 13x10, 8x9, 8x5 and 5x5 (cm) ▪ The multi-imaging solution for Accurate Diagnostics ▪ Conventional 2D (PANO and CEPH) image acquisition ▪ 3D scanning for Plaster Cast with FOV 8x9 (cm) ▪ Touch Screen implemented for easy use ▪ DICOM (Digital Imaging Communication in Medicine) format supported Imaging System Overview Configuration Item SP PANO +CBCT SC PANO + CBCT + CEPH Green 18 (Model: PHT-65LHS) User Manual Sensor PANO / CBCT Xmaru1515CF PANO / CBCT Xmaru1515CF CEPH Xmaru2602CF 19 4. Imaging System Overview 4.4 Standards and Regulations Standards Green 18 (PHT-65LHS) is designed and developed to comply with the following international standards and regulations: ▪ MEDICAL - APPLIED ELECTROMAGNETIC RADIATION EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601‐1 (2005) + AMD 1 (2012) CAN/CSA‐C22.2 No. 60601‐1 (2014) IEC 60601-1-3:2008, IEC 60601-2-63:2012 ▪ 21 CFR 1020.30, 31, 33 ▪ NEMA Standard publication PS 3.1-3.18, 2008 This is Class IIb equipment and obtained CE marking in April 2007 for regulations compliance following the revised European Union’s MDD (Medical Devices Directive) 93/42 EEC. MEDICAL - APPLIED ELECTROMAGNETIC RADIATION EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601‐1 (2005) + AMD 1 (2012) CAN/CSA‐C22.2 No. 60601‐1 (2014) IEC 60601-1-3:2008, IEC 60601-2-63:2012 Classifications (IEC 60601-1 6.1) 20 ▪ The degree of protection against water ingress: Ordinary Equipment: IPX0 ▪ The degree of protection against electric shock: Class 1 equipment, Type B Applied parts: temple supports, chinrests, bites and covers, ear rods and caps, and carpus plate Green 18 (Model: PHT-65LHS) User Manual 4. Imaging System Overview 4.5 Operating Principles They hit anode to produce an X-ray. The machine acquires images by emitting X-rays continuously and rotates on the human tooth at different angles. Images are acquired, computed, and recompiled to reproduce 2D or 3D images. 4.6 Imaging System Configuration Green 18 (Model: PHT-65LHS) User Manual 21 ENGLISH X-ray is emitted when a high voltage is supplied to the X-ray tube assembly, freeing electrons from the cathode. 4. Imaging System Overview PC Signal Input / Output No. 22 Item 1 3D viewer License Key 2 Video output 3 Fiber optic cable (for data in / out) Green 18 (Model: PHT-65LHS) User Manual 4. Imaging System Overview 4.7 Equipment Overview ENGLISH No. Item 1 X-ray Detector for CEPH (Optional) Xmaru2602CF for CEPH imaging sensor. 2 Nasal Positioner Assists patient positioning for CEPH imaging. 3 Ear Rods Secure the patient’s head during CEPH imaging. 4 Description Enclosed Stores Bites, Chinrest Assembly, and the other Component Storage components. 5 Vertical Frame Holds the Rotating Unit. You can control the vertical frame with the Column UP/DOWN switch. 6 Rotating Unit Rotates around the patient's head while the image is being acquired. (Its movement varies based on the scan mode) 7 X-ray Generator Produces X-ray from the vacuum tube. 8 Emergency Stop Switch Stops the moving parts and cuts off all power to the equipment’s electrical components. Green 18 (Model: PHT-65LHS) User Manual 23 4. Imaging System Overview No. Item Description 9 Main Power Switch Turns on / off the main power of the equipment. 10 Column UP/DOWN Switch (Optional) Adjusts the height of the Vertical Frame. 11 Stationary Column Supports the whole part of the equipment. 12 Base (Optional) Balances the equipment and maintains its safety. 13 LED Lamp 14 X-ray Detector for PANO / CBCT Xmaru1515CF for PANO / CBCT imaging sensor. 15 Temple Supports Supports the patient’s head by holding the temples. It is used in PANO and CBCT modes. 16 Chinrest Displays the status of X-ray exposure. - Green: Standby - Yellow: In operation A place to rest the chin. Operates the Horizontal Beam, opens/closes Temple Supports, adjusts the height of the Vertical Frame, and prepares for operation when the READY button is pressed. (For the details, refer to 4.7.1 Control Panel.) 24 17 Control Panel (LCD type) 18 D-Sub Connector The input signal port for Column UP/DOWN Switch. Green 18 (Model: PHT-65LHS) User Manual 4. Imaging System Overview 4.7.1 Control Panel ENGLISH No. Buttons Description 1 Touch Screen (LCD) Configures the parameter settings in each imaging mode. For more information, refer to the 4.7.2 Touch Screen. 2 TEMPLE SUPPORT Open/Close Button Adjusts the Temple Supports for patient positioning. 3 READY / RETURN Button Indicates that imaging is ready after parameter settings and the patient positioning is complete. Initializes the positioning of the Rotating Unit. 4 Horizontal BEAM UP/DOWN Button Aligns the Horizontal Beam in PANO mode. 5 COLUMN UP/DOWN Button Moves the Vertical Frame up or down. (For adjusting the height of the Chinrest) Green 18 (Model: PHT-65LHS) User Manual 25 4. Imaging System Overview 4.7.2 Touch Screen The touch screen is provided to set options for each imaging mode. The screen is connected to the console software and provides the same functions as the software (See 5.3 Console Software). Only users can turn on and change the settings of the touch screen. Modality Selection Screen ▪ ▪ ▪ Do not use a pointed object such as a pen to touch the screen panel. Pressing the screen with an object other than fingers can damage the screen. Do not press the touch screen hard when you are selecting options. Pressing hard can cause cracks and other damage to the screen. Never allow the patients to change settings on the touch screen to avoid physical injuries or damage to the equipment. “CEPH” is visible on the modality selection screen only when your equipment has the CEPH option. 26 Green 18 (Model: PHT-65LHS) User Manual 4. Imaging System Overview PANO Main Screen ENGLISH PANO Main Screen No. Function 1 Examination Mode Selection 2 CONFIRM Button 3 Imaging Parameter Displays the current PANO setting information. Setting Information 4 Settings Button 5 Back Button Description Selects a PANO examination mode. Confirms the setting you chose and moves to the next step. Changes in the imaging parameters include: ▪ Tube voltage ▪ Tube current ▪ Patient’s gender and age ▪ X-ray intensity ▪ Examination type ▪ Imaging type ▪ Arch type ▪ Image option Returns to the modality selection screen. Green 18 (Model: PHT-65LHS) User Manual 27 4. Imaging System Overview PANO Settings Screen PANO Settings Screen 28 No. Function Description 1 Selection 2 Pano Option 3 Arch 4 Image Option Selects an image quality. (Image quality: High Resolution > Green) 5 kVp / mA Control Button Changes tube voltage (kVp) and current (mA) values. 6 Gender / Age Option Selects a gender and age for your patient. For age selection, follow the guidelines below: ▪ Child: 2~12 years of age ▪ Adult: Above 12 years of age 7 X-ray Intensity Selects one of the X-ray intensities according to the patient’s head circumference: ▪ Soft ▪ Normal ▪ Hard 8 EXIT Button Closes the settings page and returns to PANO main screen. Selects an examination program. Selects a PANO option. Selects an arch type that matches with patient’s arch shape. Green 18 (Model: PHT-65LHS) User Manual 4. Imaging System Overview CEPH Main Screen ENGLISH CEPH Main Screen No. Function 1 Examination Mode Selection 2 CONFIRM Button 3 Imaging Parameter Displays the current setting information. Information 4 Settings Button 5 Back Button Description Selects a CEPH examination mode. Confirms the setting you chose and moves to the next step. Changes the imaging parameters, including: ▪ Tube voltage ▪ Tube current ▪ Patient’s gender and age ▪ X-ray intensity ▪ Image option Returns to the modality selection screen. Green 18 (Model: PHT-65LHS) User Manual 29 4. Imaging System Overview CEPH Settings Screen CEPH Settings Screen 30 No. Function Description 1 kVp / mA Control Button Adjusts tube voltage (kVp) and current (mA). 2 Gender / Age Option Selects the patient’s gender and age. For age selection, follow the guidelines below: ▪ Child: 2~12 years of age ▪ Adult: Above 12 years of age 3 X-ray Intensity Selects different X-ray intensities according to the circumference of the patient’s head: ▪ Soft ▪ Normal ▪ Hard 4 Image Option Selects an image quality. (Image quality: High Resolution > Green) 5 Exit Button Closes the settings page and returns to CEPH main screen. Green 18 (Model: PHT-65LHS) User Manual 4. Imaging System Overview CBCT Main Screen ENGLISH CBCT Main Screen No. Function Description 1 FOV Selection Selects a FOV for CBCT imaging. 2 CONFIRM Button Confirms the settings you chose and moves to the next step. 3 Imaging Parameter Displays the current CBCT setting information. Information 4 Settings Button Allows you to change the imaging parameters. including: ▪ Tube voltage ▪ Tube current ▪ Patient’s gender and age ▪ X-ray intensity ▪ Image option ▪ Voxel Size 5 Back Button Returns to the modality selection screen Green 18 (Model: PHT-65LHS) User Manual 31 4. Imaging System Overview CBCT Settings Screen CBCT Settings Screen No. Function Description Selects an image quality. (Image quality: High Resolution > Green) 32 The Image Option menu becomes invisible on the touch screen when you disable Green on the console software. 1 Image Option 2 Voxel Size 3 kVp / mA Control Button Adjusts tube voltage (kVp) and Tube current (mA). 4 Gender / Age Option Selects a gender and age for your patient. For age selection, follow the guidelines below: ▪ Child: 2~12 years of age ▪ Adult: Above 12 years of age 5 X-ray Intensity Selects different X-ray intensities according to the circumference of the patient’s head: ▪ Soft ▪ Normal ▪ Hard 6 Exit Button Closes the settings screen and returns to CBCT main screen. Selects a voxel size for the image. Green 18 (Model: PHT-65LHS) User Manual 4. Imaging System Overview 3D MODEL Scan Main Screen ENGLISH 3D Model Scan Main Screen No. Function Description 1 Examination Mode Selects a 3D model scan examination mode. Selection 2 CONFIRM Button 3 Imaging Parameter Displays the current setting information. Information Confirms the settings you selected and moves to the next step. 4 Settings Button Allows you to change the imaging parameters, including: ▪ Tube voltage ▪ Tube current ▪ Patient’s gender and age ▪ X-ray intensity 5 BACK Button Returns to the modality selection screen. Green 18 (Model: PHT-65LHS) User Manual 33 4. Imaging System Overview 3D MODEL Scan Settings Screen 3D Model Scan Settings Screen No. 34 Function Description 1 kVp / mA Adjusts tube voltage (kVp) and Tube current (mA). Control Button 2 Selects a gender and age for your patient. For age selection, Gender / Age follow the guidelines below: ▪ Child: 2~12 years of age Option ▪ Adult: Above 12 years of age 3 Selects different X-ray intensities according to the circumference of the patient’s head: ▪ Soft X-ray Intensity ▪ Normal ▪ Hard 4 EXIT Button Closes the settings screen and moves back to the 3D model scan main screen. Green 18 (Model: PHT-65LHS) User Manual 4. Imaging System Overview 4.7.3 Emergency Stop Switch After the problem is resolved, turn the switch until it pops up to restart the system. An emergency may include the following situations but is not limited to: ▪ ▪ ▪ Continuing X-ray emission (when the exposure switch is not pressed) Physical injuries of the patient Damages to the equipment and other properties. Green 18 (Model: PHT-65LHS) User Manual 35 ENGLISH Press the Emergency Stop Switch to stop the equipment in an emergency. The switch is located under the handle frame. As you press the switch, the equipment will stop. 4. Imaging System Overview 4.7.4 Exposure Switch The Exposure Switch allows the operator to control image acquisition outside the Xray room. Press and hold the Exposure Switch down until the acquisition is complete. Premature release of the Exposure Switch will abort image acquisition. Pressing the Exposure Switch activates the LED indicator to turn yellow. This color indicates that the X-ray is being emitted. ▪ ▪ 36 The Exposure Switch is detachable. Ensure that the Exposure Switch cable is not detached from the unit accidentally during operation. Keep vocal/visual contact with the patient during exposure. If any problem occurs during exposure, release the Exposure Switch immediately. Green 18 (Model: PHT-65LHS) User Manual 4. Imaging System Overview 4.7.5 Enclosed Components Components Name and Function Materials Normal Bite - For PANO and CBCT, normal patients PC (Polycarbonate) Deep Bite Block* PC (Polycarbonate) Special Bite A - For PANO TMJ and Sinus modes - For CBCT TMJ patients PC (Polycarbonate) Special Bite B - For PANO edentulous patients - For CBCT Double scan (Mandible) mode. PC (Polycarbonate) Double Scan Support - For CBCT Double scan (Maxilla) mode. PC (Polycarbonate) Normal Chinrest - For Normal Bite - For CBCT Double scan (Mandible) mode. ABS (Acrylonitrile butadiene styrene) copolymer Special Chinrest - For Special Bite A and Special Bite B ABS (Acrylonitrile butadiene styrene) copolymer Temple Supports (1 set) PC (Polycarbonate) Ear Rods (1 set) Silicone Nasal Positioner Cover - For CEPH Silicone Green 18 (Model: PHT-65LHS) User Manual 37 ENGLISH The enclosed components listed below can be detached from the equipment. The components that come to touch with the patient, such as bite blocks and chinrest, must be cleaned with non-alcoholic chlorine dioxide-based disinfectant for each use. 4. Imaging System Overview Components Name and Function Materials PC (Polycarbonate) Carpus Plate Sanitary Vinyl Covers (disposable) for the Bite Block PP+PE Protractor (1 set) - For positioning the patient’s body in CEPH mode. PC (Polycarbonate) Model Scan Jig ABS (Acrylonitrile butadiene styrene) copolymer *Deep Bite Block is only available in some Asian countries. 38 Green 18 (Model: PHT-65LHS) User Manual 5. Imaging Software Overview Imaging Software Overview ENGLISH 5. Three programs are included in this equipment to acquire, process, and view the image: 5.1 ▪ EzDent-i: 2D viewer and patient management software ▪ Ez3D-i: 3D viewer software ▪ Console software: PANO, CEPH (Optional), CBCT, and 3D MODEL Scan PC Specifications (Recommended) If your PC does not meet the recommended specifications provided below, it may result in degraded image quality. Prior to using the PC, ensure that Windows Defender Firewall is enabled to protect your PC and data from network security threats. Item Specifications CPU Intel Xeon W-2223 3.6 GHz 4 Core Processor RAM 16GB DDR4-2133 Registered RAM or larger HDD 1TB SATA Graphics board NVIDIA GeForce GTX1060 D5 6GB or greater Ethernet Interface Integrated Intel I218LM PCIe GbE Serial Port (RS232) HP Serial Port Adapter kit Power Supply ≥ 700 Watts (90% efficient) Slots 2 PCI Express Gen3 x16 slot 1 PCI Express Gen3 x 8 Slot 1 PCI Express Gen2 x 4 Slot 1 PCI Express Gen2 x 1 Slot 1 PCI Slot CD/DVD drive DVD-ROM, DVD+/-RW, Blu-Ray Monitor 19” 1280x1024 screen resolution Operating System Recommended System Green 18 (Model: PHT-65LHS) User Manual Windows 10 HP Z4 39 5. Imaging Software Overview 5.2 EzDent-i EzDent-i is dental imaging software from VATECH Co., Ltd. manages patient images to make faster and more accurate diagnoses. EzDent-i, linked with the console software and 3D viewer, makes it convenient for the operator to use and process necessary images. Various functions enable the acquired images to be processed quickly and conveniently from the console software. Please refer to 6.2.1 Creating a New Patient Record, 6.2.2 Retrieving Patient Records, and EzDent-i User Manual. Security Capabilities ▪ It is recommended to install and operate EzDent-i SW within a secure environment that allows only authorized users to access and a system network equipped with Windows built-in firewall, Windows Defender antispyware tools, and other commonly used 3rd party security tools and application systems. ▪ It is recommended to update the latest version of antivirus software and firewall. ▪ The software can be updated by the manufacturer only. Unauthorized software update through a third party, not the manufacturer, is strictly prohibited. Please contact the manufacturer for cyber security issues related to the software and medical devices. 40 Green 18 (Model: PHT-65LHS) User Manual 5. Imaging Software Overview 5.3 Console Software ENGLISH Use the console software to select options for imaging. You can also use a touch screen to select and change imaging options. Due to product enhancement, the console software can be updated without notice. Console Software’s Main Window Green 18 (Model: PHT-65LHS) User Manual 41 5. Imaging Software Overview No. 1 42 Item X-ray Indicator Description Indicates X-ray exposure status by changing the indicator’s color and message. ▪ Grey and “X-RAY”: X-ray is turned off ▪ Yellow and “X-RAY ON”: X-ray is turned on 2 Settings Button Sets various equipment-related parameters, including: ▪ Language ▪ Automatic Save on/off ▪ DAP display unit 3 Volume Button Changes the volume of the audio message. Ensure to save your change each time you reset the volume. 4 Laser Beam ON/OFF Button Turns the laser beam on or off for patient positioning. This button appears after you click the CONFIRM button. 5 Manual Reconstruction Button Reconstructs the captured image manually when the system fails to run automatic image reconstruction. Follow the instructions below for manual reconstruction: (1) Click a manual reconstruction. (2) Select a modality. (3) Click Search. (4) Select an image for reconstruction. (5) Click Reconstruction. 6 Phantom Button Switches the system for the phantom image acquisition using a phantom jig. 7 Test Rotation Button Sets the system for a rotation test, which checks if the rotating unit hits the patient’s body before imaging. To run a rotation test, follow the procedure below: (1) Ask the patient to position the equipment. (2) Select a modality. (3) Click the Confirm button. (4) Click the Test Rotation Button. Then “ON” on the button is changed into “OFF.” (5) Press the Laser Beam ON/OFF button on the control panel. (6) To finish the test mode, click the Test Rotation button or the READY button. 8 Patient Information Window Displays the information of a selected patient. Green 18 (Model: PHT-65LHS) User Manual 5. Imaging Software Overview Item Description 9 Scan Information Window Displays estimated DAP (Dose Area Product), scan time, and exposure time after you set up X-ray exposure parameters. 10 Tube Voltage and Current Buttons Changes tube voltage (kVp) and current (mA) values. Click arrows to modify the voltage and current originally set by the system. 11 Guide Message Window Displays text instructions during the operation. ENGLISH No. Displays the current patient’s gender/age group as entered in EzDent-i’s patient information fields. If necessary, the gender/age group can be selected manually. 12 Patient’s Gender/Age Group 13 X-ray Intensity 14 CONFIRM / Ready Button Selects X-ray intensity. Applies selected options and turns into the Ready button. The Ready button appears after you click CONFIRM button. When you click the button, the system becomes ready for image acquisition. 15 Modality Selection Button Selects the imaging parameters for each mode: PANO, CEPH (Optional), CBCT, and 3D MODEL Scan. 16 Exit Button Leaves the console software. Green 18 (Model: PHT-65LHS) User Manual 43 5. Imaging Software Overview This Page is Left Blank Intentionally 44 Green 18 (Model: PHT-65LHS) User Manual 6. Getting Started Getting Started 6.1 Turning on the Equipment ▪ ▪ ▪ ▪ ▪ ENGLISH 6. Do not place the patient close to the equipment when it’s being turned on. Doing so may cause physical injury to the patient and damage to the equipment. Do not use the PC while the equipment is in operation. Doing so may cause an error in the equipment. Do not turn the equipment on until the X-ray room reaches room temperature. The extreme change in temperature may lead to condensation inside the equipment. After turning it off, wait for approx. 20 seconds before rebooting it. Warm up the equipment for at least 5 minutes before the operation. For the best image quality, it is recommended to have a warm-up phase for more than 30 minutes. If the equipment has not been used for a long time, please let it have enough time to be warmed up. It extends the life of the X-ray tube. The imaging system mainly consists of the imaging equipment and the PC. Before turning on the equipment, please confirm that the equipment and PC have been installed correctly. 1. Turn on the PC. 2. Press the Main Power Switch, which is located under the bottom of the Vertical Frame, to turn on the equipment. Main Power Switch simultaneously isolates its circuits electrically from the supply mains on all poles. 3. Ensure that the green LED light at the top of the equipment is on. Green 18 (Model: PHT-65LHS) User Manual 45 6. Getting Started 6.2 Running the Image Viewer (EzDent-i) The imaging program is interfaced with EzDent-i, and the user can analyze the image acquired from the Console Software easily and rapidly. On your desktop, double-click the EzDent-i icon. The EzDent-i main window will be displayed. For further details on this subject, refer to the EzDent-i User Manual. Security Capabilities ▪ It is recommended to install and operate EzDent-i SW in a secure environment that allows only authorized users to access the system. It has a system network equipped with Windows built-in firewall, Windows Defender antispyware tools, and other commonly used 3rd party security tools and application systems. ▪ It is recommended to update the latest version of antivirus software and firewall. ▪ The software can be updated by the manufacturer only. Unauthorized software update through a third party, not the manufacturer, is strictly prohibited. Please contact the manufacturer for cybersecurity issues related to the software and medical devices. For Green 18 (PHT-65LHS) dental computed tomography Xray system, both 3D viewer (Ez3D-i) and Console Software are being accessed through 2D viewer (EzDent-i) SW. 3D viewer and Console Software do not have an image storage capacity of their own, and both programs will not be able to keep patient information. 46 Green 18 (Model: PHT-65LHS) User Manual 6. Getting Started 6.2.1 Creating a New Patient Record ENGLISH Follow the procedure below to create a new patient record: EzDent-i’s Main Window 1. Click the PATIENT tab and button. . A dialog box will appear after clicking the 2. In the dialog box, fill out Chart No. and Name. If necessary, fill out other areas such as social ID and mobile. 3. Click to save the new patient record. The chart number and name are required fields. You cannot leave them as blanks. Green 18 (Model: PHT-65LHS) User Manual 47 6. Getting Started 6.2.2 Retrieving Patient Records Follow the procedure below to retrieve the patient record saved in EzDent-i: 1. Go to the search box and enter the patient’s name or chart number. 2. Click 3. Check and double-click the patient record with the matching chart number or name. . Patient Record You can use a virtual keyboard to search for the patient record. Click the keyboard icon next to the search box if you want to use the virtual keyboard: 48 Green 18 (Model: PHT-65LHS) User Manual 6. Getting Started 6.2.3 Launching the Console Software ENGLISH Follow the procedure below to initiate the console software. For a new patient, you must create the new patient before running the console software. Go to 6.2.1 Creating a New Patient Information for more information. 1. Search and select the patient record. 2. Click the ACQUISITION tab. 3. Select the modality you want to capture. The displayed options can be different depending on your equipment’s option. To set exposure parameters for each modality (CT, Panorama, Cephalo, Others), Read chapters 7 to 10. Green 18 (Model: PHT-65LHS) User Manual 49 6. Getting Started This Page is Left Blank Intentionally 50 Green 18 (Model: PHT-65LHS) User Manual 7. Acquiring PANO Images Acquiring PANO Images 7.1 PANO Imaging Program Overview ◼ ENGLISH 7. Result Images It provides conventional 2D panoramic images. ◼ Image Acquisition Method It reconstructs U-shaped arch data to a single 2D image utilizing multiple images taken with the X-ray beam scanning specific oral & maxillofacial regions at different angles. ◼ Examination Programs It is classified below based on the ROI (Region of Interest). Examination Type Arch Selection ROI Example Standard Narrow Normal Wide Child Orthogonal Right Front PANO Examination Left Bitewings* Orthogonal Bitewing Incisor* (Optional) Green 18 (Model: PHT-65LHS) User Manual 51 7. Acquiring PANO Images Examination Type Arch Selection ROI Example Bitewing Right* Bitewing Left* TMJ LAT Open TMJ LAT Close TMJ PA Open (Optional) SPECIAL Examination N/A TMJ PA Close (Optional) Sinus LAT (Optional) Sinus PA * Bitewing imaging mode is activated only when Orthogonal is selected in Arch Selection. 52 Green 18 (Model: PHT-65LHS) User Manual 7. Acquiring PANO Images ◼ Main Imaging Programs Arch Selection ROI ENGLISH Examination Type Description & Sample Image A panoramic imaging mode for patients with a V-shaped arch trajectory. (Typically for some females) Narrow Standard A panoramic imaging mode for adult patients with a typical arch trajectory. Normal Standard PANO Examination A panoramic imaging mode for the patients with a square-shaped arch trajectory. (Typically for some males) Wide Child Green 18 (Model: PHT-65LHS) User Manual Standard Standard A panoramic imaging mode for child trajectory. (Less X-ray exposure than the Normal mode by approximately more than 40%) 53 7. Acquiring PANO Images Examination Type Arch Selection ROI Description & Sample Image A panoramic imaging mode to minimize the overlapped region of the teeth from the X-ray exposure, which is beamed perpendicularly between teeth. Standard A panoramic imaging mode to acquire an image only for the region of interest through the orthogonal trajectory. (Pros: less X-ray exposure than the Normal mode. / Cons: TMJ and some parts of the maxillary sinus cannot be acquired.) Orthogonal Bitewings** (Bitewing Incisor mode is Optional) 54 Green 18 (Model: PHT-65LHS) User Manual 7. Acquiring PANO Images Arch Selection ROI Description & Sample Image ENGLISH Examination Type An imaging mode to acquire a lateral image of the TMJ, in which the X-ray beam is directed on the lateral TMJ region. (TMJ Open and Close) TMJ LAT Open / Close An imaging mode to acquire a TMJ image, in which the X-ray beam is directed on the frontal TMJ, with the patient's mouth open fully and closed. TMJ PA Open / Close (Optional) SPECIAL Examination N/A Sinus LAT (Optional) A special imaging mode to acquire a Sinus image, in which an X-ray beam is directed on the lateral region of the maxillary sinus. A special imaging mode to acquire a Sinus image, in which an X-ray beam is directed at the frontal region of the maxillary sinus. Sinus PA ** Bitewing imaging mode is activated only when Orthogonal is selected in Arch Selection. Green 18 (Model: PHT-65LHS) User Manual 55 7. Acquiring PANO Images 7.2 Setting Exposure Parameters Complete the steps in 6. Getting Started before setting the exposure parameter on the console. You can also use the touch screen to set the exposure parameters. Console Software - Main Window Touch Screen - Main Window 56 Green 18 (Model: PHT-65LHS) User Manual 7. Acquiring PANO Images 7.2.1 Setting Parameters on the Normal Tab ENGLISH To set exposure parameters on the normal tab. 1. Select PANO from the modality option. 2. Select the Normal tab. 3. Select a PANO option: Normal, Magic Pan, Insight Pan Mode Normal Magic PAN (Optional) Description ▪ Provides a normal panoramic image. ▪ Combines multiple focal images into a single optimal panoramic image. Equalizes varying image qualities caused by patient positioning and arch type and provides an enhanced panoramic image. ▪ ▪ Insight PAN (Optional) ▪ Provides multiple panoramic images with different focal planes and a normal panoramic image. Provides detailed verification of images' in-depth direction. When you select the Insight Pan: ▪ ▪ The image option menus are disabled. The arch selection menu is disabled except Normal and Child. ▪ The imaging area is highlighted in the guide window. You can drag or move the selected area to mark the imaging target. (Only for the console software) Green 18 (Model: PHT-65LHS) User Manual 57 7. Acquiring PANO Images 4. 5. Select an Image Option: High Resolution or Green Mode Description High Resolution High-Resolution image Green Normal quality image Select an arch type from the Arch Selection menu. Arch Type Narrow Panoramic image of V-shaped palatal arches Normal Panoramic image of normal adult palatal arches Wide Panoramic image of square-shaped palatal arches Child Panoramic image of child palatal arches, approximately more than 40% less X-ray dose than in Normal mode. Orthogonal 6. Description Panoramic image where the x-ray angle enters vertically between the teeth so that overlapping images are minimized. Select a PANO Examination option. The patient type, X-ray intensity level, tube voltage (kVp), and current (mA) are automatically selected by the patient record you created. However, you can manually change the options from console software or touch screen if necessary. 58 Green 18 (Model: PHT-65LHS) User Manual 7. Acquiring PANO Images 7. Select the patient type from the patient selection menu. ENGLISH Mode Child Adult 8. Man Woman > 12 years of age Select the X-ray intensity level: hard, normal, or soft. Age Child Adult 9. Vatech Standards 2~12 years of age Average Head Circumference (cm) 53±3 56±3 Range (cm) X-ray Intensity >53±3 Hard 53±3 Normal <53±3 Soft >56±3 Hard 56±3 Normal <56±3 Soft The system automatically configures the exposure condition based on previous parameters chosen by the user. However, you can customize the preselected condition by using the ( ) button. Each time you click the button, the voltage value is changed by ±1.0 kVp and the current by ± 1.0 mA. <Console Software> Green 18 (Model: PHT-65LHS) User Manual <Touch Screen> 59 7. Acquiring PANO Images 10. Click the Confirm button. After clicking the Confirm button: 60 ▪ The rotating unit moves to set position based on the selected modality. ▪ The vertical beam activates. ▪ The patient information window displays the DAP (Dose Area Product), scan time, and exposure time. Green 18 (Model: PHT-65LHS) User Manual 7. Acquiring PANO Images 7.2.2 Setting Parameters on the Special Tab ENGLISH You can set exposure parameters for the special examination mode (sinus / TMJ) on the special tab. You can also use the touch screen to set the exposure parameters. The patient type, X-ray intensity level, tube voltage (kVp), and current (mA) are automatically selected by the patient record you created. However, you can manually change the console software or touch screen options if necessary. Follow the procedure below to set parameters on the special tab. 1. Select the Special tab. 2. Select an option from the PANO Examination menu. 3. Select the patient type: Man, Woman, or Child. Mode Vatech Standards Child 2~12 years of age Adult 4. Man > 12 years of age Woman Select the X-ray intensity level: hard, normal, or soft. For the recommended X-ray intensity level, see the table below. Age Average Head Circumference (cm) >53±3 Hard Child 53±3 53±3 <53±3 >56±3 Normal Soft Hard Adult 56±3 56±3 Normal <56±3 Soft Green 18 (Model: PHT-65LHS) User Manual Range (cm) X-ray Intensity 61 7. Acquiring PANO Images 5. The system automatically configures the exposure condition based on previous parameters chosen by the user. However, you can customize the preselected condition by using the ( ) button. Each time you click the button, the voltage value is changed by ±1.0 kVp and the current by ± 1.0 mA. <Console Software> 6. Click the Confirm button. After clicking the Confirm button: ▪ ▪ ▪ 62 <Touch Screen> The rotating unit moves to set position based on the selected modality. The vertical beam activates. The patient information window displays the DAP (Dose Area Product), scan time, and exposure time. Green 18 (Model: PHT-65LHS) User Manual 7. Acquiring PANO Images 7.3 Patient Positioning ▪ ▪ ▪ ▪ Ask the patient (especially pregnant women and children) to wear a lead apron to protect him or her from radiation exposure. Ensure that the laser beam does not directly enter the patient’s eyes. This may lead to vision loss. Correct posture reduces the shadows made by the patient's cervical spine and allows clear image acquisition. Metal implants or bridges can reduce the quality of the images. Ensure to adjust the laser beam correctly. Otherwise, the quality of images can be lowered due to ghost images or expansion/reduction of the images. Getting prepared 1. Let the patient remove all the metal objects (glasses, earrings, hairpins, braces, false teeth, etc.). Metal objects can induce ghost images and lower image quality. 2. Let the patient wear a lead apron to protect themselves from residual radiation. 3. Use the Column UP/DOWN button or switch option to adjust the equipment to match the patient's height. < Control Panel – LCD type> Green 18 (Model: PHT-65LHS) User Manual 63 ENGLISH ▪ 7. Acquiring PANO Images 7.3.1 PANO Examination Mode (Standard / Right / Left / Front / Orthogonal) Normal Patient Positioning 1. Insert the Normal Bite into the Normal Chinrest and cover it with sanitary vinyl cover. ▪ The sanitary vinyl cover is for single use only. It should be replaced for each patient. Ensure to use the approved vinyl cover. ▪ Clean the chinrest and the bite with a nonalcoholic chlorine dioxide-based product and wipe with a dry towel before the next patient. 2. Use the Temple Supports OPEN/CLOSE button to widen the temple supports. 3. Guide the patient to the inside of the equipment. 4. Use the Column UP/DOWN button or switch option to adjust the height of the equipment so that the patient's chin reaches the Chinrest. 5. Ask the patient to stand in the center of the equipment and direct them to remain in the position outlined below. ▪ ▪ ▪ ▪ ▪ 64 Hold the handles tightly. Press the chest against the equipment. Keep both feet close to the inside of the base. Keep both shoulders parallel. Straighten the Cervical Spine and stand still. Green 18 (Model: PHT-65LHS) User Manual 7. Acquiring PANO Images Ask the patient to bite the normal bite along its grooves with his/her front teeth. 7. Use the Temple Supports OPEN/CLOSE button to fit the patient’s head and prevent from moving. 8. Ask the patient to do as follow: ▪ ▪ ▪ ENGLISH 6. Close the mouth. Place the tongue on the roof of the mouth. Close the eyes. Green 18 (Model: PHT-65LHS) User Manual 65 7. Acquiring PANO Images Edentulous Patient Positioning 1. Remove the Normal Chinrest and insert the Special Chinrest into the equipment. 2. Insert the Special Bite B into the Special Chinrest. Clean the chinrest and the bite with a non-alcoholic chlorine dioxide-based product and wipe with a dry towel before the next patient. 3. Use the Temple Supports OPEN/CLOSE button to widen the Temple Supports. 4. Guide the patient to the equipment. 5. Use the Column UP/DOWN button or switch option to adjust the height of the equipment so that the patient's chin reaches the Chinrest. 6. Ask the patient to stand in the center of the equipment and direct them to remain in the position outlined below. ▪ ▪ ▪ ▪ ▪ 66 Hold the handles tightly. Press the chest against the equipment. Keep both feet close to the inside of the base. Keep both shoulders parallel. Straighten the Cervical Spine and stand still. Green 18 (Model: PHT-65LHS) User Manual 7. Acquiring PANO Images Use the Temple Supports OPEN/CLOSE button to fit the patient’s head and prevent from moving. 8. Ask the patient to maintain the posture as follows: ▪ ▪ ▪ Close the mouth. Place the tongue on the roof of the mouth. Close the eyes. Green 18 (Model: PHT-65LHS) User Manual 67 ENGLISH 7. 7. Acquiring PANO Images Laser Beam Alignment Ensure that the laser beam does not directly enter the patient’s eyes. This may lead to vision loss. Ensure to align the laser beam properly. Distortions can be found in the captured images, such as ghost shadows if the laser beam is not correctly positioned. 1. Align the Vertical Beam to the center of the face (Mid-sagittal Line) to prevent the horizontal expansion of the image. 2. Use the Horizontal Beam button on the control panel to position it. Align the Horizontal Beam straight to the Frankfurt Line on the patient's face. Make sure that the Horizontal Beam is aligned to the patient's face horizontally. 3. Direct the patient to smile and align the Canine Teeth Beam to the center of the canines. Use the Canine Teeth Beam Lever to adjust the position of the beam. Finishing Patient Positioning 68 1. Ensure that the Temple Supports are at the CLOSE position before clicking the READY button. 2. Click the READY button. X-ray exposure has not started yet. 3. Go to 7.4 X-ray Exposure to start the exposure. Green 18 (Model: PHT-65LHS) User Manual 7. Acquiring PANO Images SPECIAL Examination Mode (TMJ / Sinus) 7.3.2.1 TMJ Open (LAT / PA) ENGLISH 7.3.2 To acquire a TMJ open image, follow the procedure below: Patient Positioning 1. Remove the Normal Chinrest and insert the Special Chinrest into the equipment. 2. Insert the Special Bite A into the Special Chinrest Clean the chinrest and the bite with a non-alcoholic chlorine dioxide-based product and wipe with a dry towel before the next patient. 3. Use the Temple Supports OPEN/CLOSE button to widen the Temple Supports. 4. Guide the patient to the equipment. 5. Use the Column UP/DOWN button or switch option to adjust the height of the equipment so that the patient's chin reaches the chinrest. Green 18 (Model: PHT-65LHS) User Manual 69 7. Acquiring PANO Images 6. Ask the patient to stand in the center of the equipment and direct them to remain in the position outlined below. ▪ ▪ ▪ ▪ ▪ 7. Hold the handles tightly. Press the chest against the equipment. Keep both feet close to the inside of the base. Keep both shoulders parallel. Straighten the Cervical Spine and stand still. Ask the patient to press the base of the nose (acanthion point) against the chinrest and tilt the head forward about 5˚. Ensure that the patient’s jaw does not touch the equipment to maintain the proper posture until the end of imaging. 8. Use the Temple Supports OPEN/CLOSE button to fit the patient’s head and prevent from moving. 9. Ask the patient to maintain the posture as follows: ▪ ▪ ▪ Open the mouth. Place the tongue on the roof of the mouth. Close the eyes. ▪ As shown in the picture, the support unit of the integrated chinrest should touch the patient's acanthion point. ▪ Ask the patient to maintain his/her position until the operation is completed. 70 Green 18 (Model: PHT-65LHS) User Manual 7. Acquiring PANO Images Laser Beam Alignment ENGLISH Ensure that the laser beam does not directly enter the patient’s eyes. Ensure to align the laser beam properly. Distortions can be found in the captured images, such as ghost shadows if the laser beam is not correctly positioned. 1. Align the Vertical Beam with the center of the face (Mid-sagittal Line). (It’s to prevent the horizontal expansion of the image) 2. Use the Horizontal Beam button on the control panel to position it. Align the Horizontal Beam straight to the Frankfurt Line on the patient's face. Make sure that the Horizontal Beam is aligned to the patient's face horizontally. Finishing Patient Positioning 1. Ensure that the Temple Supports are at the CLOSE position before clicking the READY button. 2. Click the READY button. X-ray exposure has not started yet. 3. Move to 7.4 X-ray Exposure to start the exposure. Green 18 (Model: PHT-65LHS) User Manual 71 7. Acquiring PANO Images 7.3.2.2 TMJ Close (LAT / PA) You can proceed with TMJ close mode only after finishing the TMJ open mode. To acquire a TMJ close image, follow the procedure below: Patient Positioning 1. "Do you want to capture a TMJ Close image?" message will appear when the TMJ Open mode is completed. Press/Click the OK button to begin TMJ Close mode. 2. Guide the patient to the equipment. 3. Ask the patient to place the base of the nose (acanthion point) against the Chinrest and bend the head forward about 5˚ 4. Ask the patient to maintain the posture as follows: ▪ ▪ ▪ Close the mouth. Place the tongue on the roof of the mouth. Close the eyes. ▪ As shown in the picture, the support unit of the integrated Chinrest should touch the patient's acanthion point. ▪ Let the patient maintain his/her position until the operation is completed. Laser Beam Alignment This is the same as the one for TMJ Open Mode. Finishing Patient Positioning This is the same as the one for TMJ Open Mode. 72 Green 18 (Model: PHT-65LHS) User Manual 7. Acquiring PANO Images 7.3.2.3 Sinus Mode (LAT / PA) ENGLISH To acquire a sinus image, follow the procedure below: Patient Positioning 1. Remove the Normal Chinrest and insert the Special Chinrest into the equipment. 2. Insert the Special Bite A into the Special Chinrest Clean the chinrest and the bite with a non-alcoholic chlorine dioxide-based product and wipe with a dry towel before the next patient. 3. Use the Temple Supports OPEN/CLOSE button to widen the Temple Supports. 4. Guide the patient to the equipment. 5. Use the Column UP/DOWN button or switch option to adjust the height of the equipment so that the patient's chin reaches the chinrest. Green 18 (Model: PHT-65LHS) User Manual 73 7. Acquiring PANO Images 6. Guide the patient to stand on the center of the equipment and direct them to remain in the position outlined below. ▪ ▪ ▪ ▪ ▪ 7. Hold the handles tightly. Press the chest against the equipment. Keep both feet close to the inside of the base. Keep both shoulders parallel. Straighten the Cervical Spine and stand still. Ask the patient to maintain the base of the nose (acanthion point) against the Chinrest and tilt the head forward about 5˚. Ensure that the patient’s jaw does not touch the equipment to maintain the proper posture until the end of imaging. 8. Use the Temple Supports OPEN/CLOSE button to fit the patient’s head and prevent from moving. 9. Ask the patient to maintain the posture as follows: ▪ ▪ ▪ Close the mouth. Place the tongue on the roof of the mouth. Close the eyes. ▪ As shown in the picture, the support unit of the integrated Chinrest should touch the patient's acanthion point. ▪ Ask the patient to maintain his/her position until the operation is completed. 74 Green 18 (Model: PHT-65LHS) User Manual 7. Acquiring PANO Images Laser Beam Alignment ENGLISH Ensure that the laser beam does not directly enter the patient’s eyes. This may lead to vision loss. Ensure to align the laser beam properly. Distortions can be found in the captured images, such as ghost shadows if the laser beam is not correctly positioned. 1. Align the Vertical Beam with the center of the face (Mid-sagittal Line). (It’s to prevent the horizontal expansion of the image) 2. Use the Horizontal Beam button on the control panel to position it. Align the Horizontal Beam straight to the Frankfurt Line on the patient's face. Make sure that the Horizontal Beam is aligned to the patient's face horizontally. Finishing Patient Positioning 1. Ensure that the Temple Supports are at the CLOSE position before clicking the READY button. 2. Click the READY button. X-ray exposure has not started yet. 3. Move to 7.4 X-ray Exposure to start the exposure. Green 18 (Model: PHT-65LHS) User Manual 75 7. Acquiring PANO Images 7.4 X-ray Exposure ▪ ▪ ▪ ▪ ▪ ▪ ▪ Release the Exposure Switch to stop X-ray emission if an emergency occurs during the image acquisition. The operator must follow the X-ray safety regulation and guidelines during the operation. The operator must keep vocal/visual contact with the patient during the image acquisition. Do not operate the PC during exposure. Ask patients to close their eyes during the operation. Ask patients to hold their breath and stop swallowing during the image acquisition. Ask patients to stay in their positions until the Temple Supports are open again. 1. Move out of the X-ray room and close the door. 2. Press and hold down the Exposure Switch until image acquisition is completed. The image appears on the screen. During X-ray exposure, the status appears as follows: ▪ The LED light of the Exposure Switch turns yellow. ▪ The LED light on the top of the equipment turns yellow. ▪ An alert sound comes out to indicate that X-ray emission is currently underway. ▪ On Console Software, the radiation mark turns yellow, and “X-RAY” changes to “X-RAY ON.” 3. 76 Release the Exposure Switch when the “Image capturing is completed” message appears on the screen. Green 18 (Model: PHT-65LHS) User Manual 7. Acquiring PANO Images 7.5 ENGLISH 7.6 Finishing the Scan 1. Open the temple supports and guide the patient out of the equipment. 2. Remove the sanitary vinyl cover from the normal bite. 3. Press the READY button from Control Panel to bring the rotating unit back to its initial position based on modality. Checking the Captured Images Acquired images can be reconstructed and converted to DICOM format. The exported images can be confirmed in EzDent-i. 1. The images are transferred to EzDent-i automatically. 2. The images are automatically saved if the automatic save option is the default. If it is not configured as default, click the Save button to save manually. 3. To check the image, double-click the image on the Patient List. Refer to the EzDent-i User Manual for more information. Green 18 (Model: PHT-65LHS) User Manual 77 8. Acquiring CEPH Images (Optional) 8. Acquiring CEPH Images (Optional) 8.1 CEPH Imaging Program Overview ◼ Result Images It provides conventional 2D cephalometric images. ◼ Image Acquisition Method It acquires multiple images by scanning the specific oral & maxillofacial regions with the linear movement of the linear detector and reconstructs them into a single 2D image through computer calculations. ◼ Examination Programs It is classified below based on the ROI (Region of Interest). Examination Area Description ▪ Lateral / Full Lateral (Optional) ▪ Studies in craniofacial disease, trauma, and congenital malformation examine the soft tissue in the otorhinolaryngological area, the sinus, and the hard palate. Measures the angles formed by the connecting lines between the cranial measurement points to further assess the growth of the facial region. It's widely used in Orthodontics and Oral and Maxillofacial Surgery. Position <Lateral> <Full Lateral> ▪ ▪ ▪ PA ▪ 78 Directs the radiation from the posterior of the skull to the anterior. Examines cranial diseases, trauma, and congenital malformations. Assesses the growth of the lateral side of the face. It also examines the ramus mandibulae, the posterior region of the thirdlargest molar in the lower jaw, the sidewall of the maxillary sinus, the frontal sinus, antrum ethmoidal, olfactory, and optic disc pits. Measures the angles formed by the connecting lines between the cranial measurement points to further assess the growth of the facial region. It is widely used in Orthodontics and Oral and Maxillofacial Surgery. <PA> Green 18 (Model: PHT-65LHS) User Manual 8. Acquiring CEPH Images (Optional) Description ▪ SMV ▪ Waters’ view Studies the base of the skull, horizontal angulation of the mandibular condylar axis, the sphenoid sinus, the curvature of the lower jaw, the sidewall of the maxillary sinus, and zygomatic arch fractures. Also used to study the inner and outer alar plates and holes at the skull base. Position ENGLISH Examination Area <SMV> Studies the frontal sinus, the antrum ethmoidal, the optic disc pit, the frontozygomatic suture, the nasal cavity, and the coronoid process between the upper jaw and the zygomatic arch. <Waters’ view> Carpus ▪ Assesses hand bone age to compare the changes in the skull. <Carpus> Green 18 (Model: PHT-65LHS) User Manual 79 8. Acquiring CEPH Images (Optional) 8.2 Setting Exposure Parameters Complete the steps in 6. Getting Started before setting the exposure parameter on the console. You can also use the touch screen to set the exposure parameters. Console Software - Main Window Touch Screen - Main Window 80 Green 18 (Model: PHT-65LHS) User Manual 8. Acquiring CEPH Images (Optional) 1. Select CEPH from the Modality Option. ENGLISH <Console Software> <Touch Screen> “CEPH” is visible on the menu only when your equipment has the CEPH option. 2. Select an image option: High Resolution or Green. <Console Software> 3. <Touch Screen> Select an examination program from CEPH Examination menu. <Console Software> Green 18 (Model: PHT-65LHS) User Manual <Touch Screen> 81 8. Acquiring CEPH Images (Optional) 4. The patient information automatically selects the patient type entered earlier. Confirm or change the patient type by clicking one of the buttons in the patient menu. <Console Software> Adult 5. Mode Vatech Standards Child 2~12 years of age Man Woman > 12 years of age Select an X-ray intensity according to the patient’s head circumference. In general, the X-ray intensity must increase proportionally to the size of the head circumference. <Console Software> Age Child Adult 82 <Touch Screen> Average Head Circumference (cm) 53±3 56±3 <Touch Screen> Range (cm) X-ray Intensity >53±3 Hard 53±3 Normal <53±3 Soft >56±3 Hard 56±3 Normal <56±3 Soft Green 18 (Model: PHT-65LHS) User Manual 8. Acquiring CEPH Images (Optional) 6. preselected condition by using the ( ) button. Each time you click the button, the voltage value is changed by ±1.0 kVp and the current by ± 1.0 mA. <Console Software> 7. Click CONFIRM when all parameter settings are complete. When you click the CONFIRM button, the following will take place: ▪ 8. <Touch Screen> The patient information window displays the DAP (Dose Area Product), scan time, and exposure time. Ask the patient to enter the unit. Green 18 (Model: PHT-65LHS) User Manual 83 ENGLISH The system automatically configures the exposure condition based on previous parameters chosen by the user. However, you can customize the 8. Acquiring CEPH Images (Optional) 8.3 Patient Positioning ▪ ▪ Ask the patient (especially pregnant women and children) to wear a lead apron to protect him or her from radiation exposure. Ensure that the laser beam does not directly enter the patient’s eyes. This may lead to vision loss. Ensure that the Nasal Positioner is unfolded before adjusting the Ear Rods properly. ▪ ▪ Correct posture reduces the shadow cast by the patient's cervical spine and allows clear image acquisition. Metal implants or bridges can reduce the quality of the images. Getting prepared 1. Let the patient remove all the metal objects (glasses, earrings, hairpins, braces, false teeth, etc.). Metal objects can induce ghost images and lower image quality. 2. Let the patient wear a lead apron to protect themselves from residual radiation. 3. Use the Column UP/DOWN button or switch option to adjust the equipment to match the patient's height. <Control Panel – LCD type> 84 Green 18 (Model: PHT-65LHS) User Manual 8. Acquiring CEPH Images (Optional) 8.3.1 Lateral / Full Lateral (Optional) Mode ENGLISH Correct posture reduces the shadow cast by the patient's cervical spine and allows clear image acquisition. Patient Positioning 1. Turn the nasal positioner to the Lateral mode positioning marker, as shown below. 2. Leave enough space between the Ear Rods. Use the Porion Position Reference Indicator that appears in the acquired image to confirm the location of Porion quickly. 3. Guide the patient to the CEPH unit. 4. Direct the patient to relax his/her neck and shoulders and stand upright. 5. Use the Column UP/DOWN button or switch option to adjust the height of the CEPH unit to approximately match the patient's height. Green 18 (Model: PHT-65LHS) User Manual 85 8. Acquiring CEPH Images (Optional) 6. Align the Ear Rods to the patient’s ears properly so that the head does not move during the operation. Then, align the Nasal Positioner with the patient’s nasion by adjusting its height. 7. Align horizontally to let the patient's Frankfurt Line become parallel with the floor. 8. Ask the patient to swallow and stay in his or her current position until image acquisition ends. 9. Click the READY button. The x-ray exposure has not started yet. 10. Move to 8.4 X-ray Exposure to start the exposure. 86 Green 18 (Model: PHT-65LHS) User Manual 8. Acquiring CEPH Images (Optional) 8.3.2 PA Mode ENGLISH Patient Positioning 1. Turn the nasal positioner to the PA / Waters’ view / Carpus mode positioning marker, as shown below. 2. Fold the nasal positioner up. The nasal positioner is NOT used in PA mode. 3. Guide the patient to the CEPH unit. 4. Ask the patient to stand upright, facing the sensor. Make sure the patient’s shoulders are level, and his/her neck is relaxed. Green 18 (Model: PHT-65LHS) User Manual 87 8. Acquiring CEPH Images (Optional) 5. Use the Column UP/DOWN button or switch option to adjust the height of the CEPH unit to approximately match the patient's height. 6. Align the Ear Rods to the patient's ears so that the head does not move during the operation. 7. Align horizontally to let the patient's Frankfurt Line become parallel with the floor. 8. Ask the patient to swallow and stay in his or her current position until image acquisition ends. 9. Click the READY button. The x-ray exposure has not started yet. 10. Move to 8.4 X-ray Exposure to start the exposure. 88 Green 18 (Model: PHT-65LHS) User Manual 8. Acquiring CEPH Images (Optional) 8.3.3 SMV Mode ENGLISH Patient Positioning 1. As shown below, turn the nasal positioner to the SMV mode positioning marker. 2. Fold the nasal positioner up. The nasal positioner is NOT used in SMV mode. 3. Guide the patient to the CEPH unit. 4. Ask the patient to face the X-ray tube and stand upright. Green 18 (Model: PHT-65LHS) User Manual 89 8. Acquiring CEPH Images (Optional) 5. Use the Column UP/DOWN button or switch option to adjust the height of the CEPH unit to approximately match the patient's height. 6. Align the Ear Rods to the patient's ears so that the head does not move during the operation. 7. Carefully tilt the patient's head back to let the patient’s Frankfurt Line become vertical with the floor. 8. Ask the patient to swallow and stay in his or her current position until image acquisition ends. . 9. Click the READY button. The x-ray exposure has not started yet. 10. Move to 8.4 X-ray Exposure to start the exposure. 90 Green 18 (Model: PHT-65LHS) User Manual 8. Acquiring CEPH Images (Optional) 8.3.4 Waters’ View Mode ENGLISH Patient Positioning 1. Turn the nasal positioner to the PA / Waters’ View / Carpus mode positioning marker, as shown below. 2. Fold the nasal positioner up. The nasal positioner is NOT used in Waters’ View mode. 3. Guide the patient to the CEPH unit. 4. Ask the patient to stand upright, facing the sensor. Make sure the patient’s shoulders are level, and his/her neck is relaxed. 5. Use the Column UP/DOWN button or switch option to adjust the height of the CEPH unit to approximately match the patient's height. After adjusting the height of the column, align the Ear Rods to the patient. 6. Align the Ear Rods to the patient's ears so that the head does not move during the operation. 7. Direct the patient to swallow first before closing the mouth and guide the patient to bend the head 30˚ - 40˚ backward. Direct the patient to remain in the current position until image acquisition is completed. 8. Click the READY button. The x-ray exposure has not started yet. 9. Move to 8.4 X-ray Exposure to start the exposure. Green 18 (Model: PHT-65LHS) User Manual 91 8. Acquiring CEPH Images (Optional) 8.3.5 Carpus Mode For Carpus Mode, install the Carpus Plate first before positioning the patient. Installing the Carpus Plate 92 1. Turn the nasal positioner to the PA / Waters’ View / Carpus mode positioning marker, as shown below. 2. Fold the nasal positioner up. The nasal positioner is NOT used in Carpus mode. 3. Fit the two ends of the Carpus Plate into the two holes of the CEPH unit as below. 4. Confirm that the Carpus Plate is safely mounted. Green 18 (Model: PHT-65LHS) User Manual 8. Acquiring CEPH Images (Optional) Patient Positioning Let the patient put his/her right hand splayed on the Carpus Plate, as shown below. Make sure that the patient does not bend his/her fingers. 2. Ask the patient to close his/her eyes and stand still until the image acquisition is completed. 3. Click the READY button. The x-ray exposure has not started yet. 4. Move to 8.4 X-ray Exposure to start the exposure. Green 18 (Model: PHT-65LHS) User Manual 93 ENGLISH 1. 8. Acquiring CEPH Images (Optional) 8.4 X-ray Exposure ▪ ▪ ▪ ▪ ▪ ▪ ▪ Release the Exposure Switch to stop X-ray emission if an emergency occurs during the imaging acquisition. The operator must follow the X-ray safety regulation and guidelines during the operation. The operator must keep vocal/visual contact with the patient during the image acquisition. Do not operate the PC during exposure. Ask patients to close their eyes during the operation. Ask patients to hold their breath and stop swallowing during the image acquisition. Ask patients to stay in their positions until the Temple Supports are open again. 1. Move out of the X-ray room and close the door. 2. Press and hold down the Exposure Switch until image acquisition is completed. The image appears on the screen. During X-ray exposure, the status appears as follows. ▪ The LED light of the Exposure Switch turns yellow. ▪ The LED light on the top of the equipment turns yellow. ▪ An alert sound comes out to indicate that X-ray emission is currently underway. ▪ On Console Software, the radiation mark turns yellow, and “X-RAY” changes to “X-RAY ON.” 3. 94 Release the Exposure Switch when the “Image capturing is completed” message appears on the screen. Green 18 (Model: PHT-65LHS) User Manual 8. Acquiring CEPH Images (Optional) 8.5 1. Leave enough space between the Ear Rods. 2. Fold the nasal positioner up in case it’s unfolded. 3. Guide the patient out of the equipment. ENGLISH 8.6 Finishing the Scan Checking the Captured Images Acquired images can be reconstructed and converted to DICOM format. The exported images can be confirmed in EzDent-i Refer to the EzDent-i User Manual for more information. 1. The images are transferred to EzDent-i automatically. 2. The images are automatically saved if the automatic save option is the default. If it is not configured as default, click the Save button to save manually. 3. To check the image, double-click the image on the Patient List. Green 18 (Model: PHT-65LHS) User Manual 95 9. Acquiring CBCT Images 9. Acquiring CBCT Images 9.1 CBCT Imaging Program Overview ◼ Result Images It provides conventional 3D CT sliced images. ◼ Image Acquisition Method It acquires images with the X-ray beam scanning specific oral & maxillofacial regions and reconstructs them into 3D sliced images. ◼ Examination Programs It is classified as below based on the FOV. Available FOVs (cm) ROI Description 18x10 <Occlusion / Center> 13x10 <Occlusion / Center> <TMJ / Right> 96 - Covers full arch region, sinus, and left/right TMJ. - Suitable for most oral surgery cases as well as multiple implant surgery. - Covers both maxillary and mandibular structures, including the 3rd molar region. - TMJ Right/Left and Airway mode are available. <TMJ / Left> Green 18 (Model: PHT-65LHS) User Manual 9. Acquiring CBCT Images ENGLISH <Airway / Center> <Occlusion / Right> 8x9 <Occlusion / Left> <Occlusion / Center> <TMJ / Right> - Selectable FOV for region (left/ center/right). - Covers both maxillary and mandibular areas and left/right TMJ. <TMJ / Left> - Selectable FOV for region (left/ center/right). - Covers both maxillary and mandibular areas. 8x5 <Mandible / Center> Green 18 (Model: PHT-65LHS) User Manual 97 9. Acquiring CBCT Images <Mandible / Left> <Mandible / Right> <Maxilla / Center> < Maxilla / Left> 5x5 <Maxilla / Right Molar> <Maxilla / Left Molar> <Maxilla / Right> 98 < Maxilla / Right> - Covers 3 ~ 4 areas through capturing ROI. - Can acquire 3 ~ 4 teeth at once. - Endo mode (Voxel Size: 0.08) applied. <Maxilla / Left> Green 18 (Model: PHT-65LHS) User Manual 9. Acquiring CBCT Images ENGLISH <Maxilla / Incisor> <Mandible / Incisor> <Mandible / Right Molar> <Mandible / Left Molar> <Mandible / Right> <Mandible / Left> 1. <Mandible / Center> Double Scan (Optional) - Full arch, sinus, left and right TMJ area can be checked - Suitable for most intra-oral surgery, including multiple implant placement 2. <Maxilla / Center> After taking 2 consecutive exposures in the order of "1 → 2", it is automatically synthesized and displayed as one full image. Green 18 (Model: PHT-65LHS) User Manual 99 9. Acquiring CBCT Images 9.2 Setting Exposure Parameters Complete the steps in 6. Getting Started before setting the exposure parameter on the console. You can also use the touch screen to set the exposure parameters. Console Software’s Main Window Touch Screen’s Main Window 100 Green 18 (Model: PHT-65LHS) User Manual 9. Acquiring CBCT Images 1. Select CBCT from the Modality Option. ENGLISH <Console Software> 2. <Touch Screen> Select a FOV (Field of View). Your selection automatically sets vertical Option, Horizontal Option, and Tooth Option. Go to the table to see corresponding options for each FOV selection. <Console Software> Green 18 (Model: PHT-65LHS) User Manual <Touch Screen> 101 9. Acquiring CBCT Images Available FOV (cm) Vertical option Horizontal option Tooth option 18x10 Occlusion Center N/A Occlusion Center 13x10 Right TMJ Left Airway N/A Center Right Occlusion Center 8x9 Left N/A Right TMJ Left Right Maxilla Center N/A Left 8x5 Right Mandible Center N/A Left Right Molar Right 5x5 Maxilla / Mandible N/A Incisor Left Left Molar 18x15 (Double Scan; 18x10 stitching) Mandible (First Scan) Maxilla (Second Scan) Center N/A (Optional) 102 Green 18 (Model: PHT-65LHS) User Manual 9. Acquiring CBCT Images 3. Select an image option: High resolution or Green. ENGLISH <Console Software> 4. Select a Voxel Size: Standard or Application. <Console Software> 5. <Touch Screen> <Touch Screen> The patient type is automatically selected by the patient information entered earlier. Confirm or change the patient type by clicking one of the buttons in the patient menu. <Console Software> Adult <Touch Screen> Mode Vatech Standards Child 2~12 years of age Man Woman Green 18 (Model: PHT-65LHS) User Manual > 12 years of age 103 9. Acquiring CBCT Images 6. Select an X-ray intensity according to the patient’s head circumference. See the table below for the suggested X-ray intensities for different head circumferences. <Console Software> Age Child Adult 7. <Touch Screen> Average Head Circumference (cm) 53±3 56±3 Range (cm) X-ray Intensity >53±3 Hard 53±3 Normal <53±3 Soft >56±3 Hard 56±3 Normal <56±3 Soft The system automatically configures the exposure condition based on previous parameters chosen by the user. However, you can customize the preselected condition by using the ( ) button. Each time you click the button, the voltage value is changed by ±1.0 kVp and the current by ± 0.1 mA. <Console Software> 8. 9. 104 <Touch Screen> Click CONFIRM when all parameter settings are complete. When you click the CONFIRM button, the following will take place: ▪ The rotating unit moves to set position based on the selected modality. ▪ The vertical beam activates. ▪ The DAP (Dose Area Product), scan time, and exposure time are displayed on the patient information window(see the figure below). Ask the patient to enter the unit. Green 18 (Model: PHT-65LHS) User Manual 9. Acquiring CBCT Images 9.3 Acquiring a Double Scan Image (optional) The following sections explain how to set exposure parameters for the double scan (see sections 9.3.1 and 9.3.2). Ensure to complete the steps in 6. Getting Started before setting the parameters. Green 18 (Model: PHT-65LHS) User Manual 105 ENGLISH Double scan mode provides a full radiographic image of the upper and lower jaw. The system runs a rapid scan of upper and lower jaws and stitches two images into one image. 9. Acquiring CBCT Images 9.3.1 Acquiring the First Scan Image Follow the procedure below to complete the first part of the double-scan procedure. 1. Click Double Scan from the FOV menu. <Console Software> <Touch Screen> 2. Select an image option: High Resolution or Green. 3. The patient type is automatically selected by the patient information entered earlier. Confirm or change the patient type by clicking one of the buttons in the patient menu. 4. Select the image option. Click the settings first when you are using the touch screen. 5. Select the X-ray intensity according to the patient’s head circumference. 6. The system automatically configures the exposure condition based on previous parameters chosen by the user. However, you can customize the preselected condition by using the ( ) button. Each time you click the button, the voltage value is changed by ±1.0 kVp and the current by ± 0.1 mA. <Console Software> <Touch Screen> 7. Press CONFIRM when all parameter settings are complete. The CONFIRM button turns to the READY button. 8. Ask the patient to enter the unit and position according to 9.4 Patient Positioning. 9. Press READY. The x-ray exposure has not started yet. 10. Follow the procedure in 9.5 X-ray exposure to launch the X-ray. 11. Ask the patient to leave the X-ray room. 106 Green 18 (Model: PHT-65LHS) User Manual 9. Acquiring CBCT Images 9.3.2 Acquiring the Second Scan Image 1. Click Maxilla from the Vertical Option menu. 2. The system automatically configures the exposure condition based on previous parameters chosen by the user. However, you can customize the preselected condition by using the ( ) button. Each time you click the button, the voltage value is changed by ±1.0 kVp and the current by ± 0.1 mA. <Console Software> 3. <Touch Screen> Click CONFIRM. When you click the CONFIRM button, the following will take place: ▪ The rotating unit moves to set position based on the selected modality. ▪ The vertical beam is activated. ▪ The patient information window displays DAP (Dose Area Product), scan time, and exposure time value. 4. Ask the patient to enter the unit and position according to 9.4 Patient Positioning. 5. Press READY. The x-ray exposure has not started yet. 6. Follow the procedure in 9.5 X-ray exposure to launch the X-ray. 7. Ask the patient to leave the X-ray room and check the image quality following the procedure in 9.6 Finishing the Scan. Green 18 (Model: PHT-65LHS) User Manual 107 ENGLISH Follow the procedure below to complete the second part of the double-scan procedure. 9. Acquiring CBCT Images 9.4 Patient Positioning ▪ ▪ ▪ ▪ ▪ Ask the patient (especially pregnant women and children) to wear a lead apron to protect him or her from radiation exposure. Ensure that the laser beam does not directly enter the patient’s eyes. This may lead to vision loss. Correct posture reduces the shadow cast by the patient's cervical spine and allows clear image acquisition. Metal implants or bridges can reduce the quality of the images. Ensure to adjust the laser beam correctly. Otherwise, the quality of images can be lowered due to ghost images or expansion/reduction of the images. Getting prepared 1. Let the patient remove all the metal objects (glasses, earrings, hairpins, braces, false teeth, etc.). Metal objects can induce ghost images and lower image quality. 2. Let the patient wear a lead apron to protect themselves from residual radiation. 3. Use the Column UP/DOWN button or switch option to adjust the equipment to match the patient's height. < Control Panel – LCD type> 108 Green 18 (Model: PHT-65LHS) User Manual 9. Acquiring CBCT Images Normal Patient Positioning Insert the normal bite into the normal chinrest and cover it with sanitary vinyl. ▪ The sanitary vinyl cover is for single use only. It should be replaced for each patient. Ensure to use the approved vinyl cover. ▪ Clean the chinrest and the bite with a non-alcoholic chlorine dioxide-based product and wipe with a dry towel before the next patient. 2. Use the Temple Supports OPEN/CLOSE button to widen the temple supports. 3. Guide the patient to the equipment. 4. Use the Column UP/DOWN button or switch option to adjust the height of the equipment so that the patient's chin reaches the Chinrest. 5. Ask the patient to stand in the center of the equipment and direct them to remain in the position outlined below. ▪ ▪ ▪ ▪ ▪ Hold the handles tightly. Press the chest against the equipment. Keep both feet close to the inside of the base. Keep both shoulders parallel. Straighten the Cervical Spine and stand still. Green 18 (Model: PHT-65LHS) User Manual 109 ENGLISH 1. 9. Acquiring CBCT Images 6. Ask the patient to bite the normal bite along its grooves with his/her front teeth. 7. Use the Temple Supports OPEN/CLOSE button to fit the patient’s head and prevent from moving. 8. Ask the patient to maintain the posture as follow: ▪ ▪ ▪ 110 Close the mouth. Place the tongue on the roof of the mouth. Close the eyes. Green 18 (Model: PHT-65LHS) User Manual 9. Acquiring CBCT Images Edentulous Patient Positioning Remove the Normal Chinrest and insert the Special Chinrest into the equipment. 2. Insert the Special Bite B into the Special Chinrest. ENGLISH 1. Clean the chinrest and the bite with a non-alcoholic chlorine dioxide-based product and wipe with a dry towel before the next patient. 3. Use the Temple Supports OPEN/CLOSE button to widen the Temple Supports. 4. Guide the patient to the equipment. 5. Use the Column UP/DOWN button or switch option to adjust the height of the equipment so that the patient's chin reaches the Chinrest. 6. Ask the patient to stand in the center of the equipment and direct them to remain in the position outlined below. ▪ ▪ ▪ ▪ ▪ 7. Hold the handles tightly. Press the chest against the equipment. Keep both feet close to the inside of the base. Keep both shoulders parallel. Straighten the Cervical Spine and stand still. Use the Temple Supports OPEN/CLOSE button to fit the patient’s head and prevent from moving. Green 18 (Model: PHT-65LHS) User Manual 111 9. Acquiring CBCT Images 8. Ask the patient to maintain the posture as follows: ▪ ▪ ▪ 112 Close the mouth. Place the tongue on the roof of the mouth. Close the eyes. Green 18 (Model: PHT-65LHS) User Manual 9. Acquiring CBCT Images Double Scan (Mandible) Patient Positioning Remove the Special Chinrest and insert the Normal Chinrest into the equipment. 2. Insert the Special Bite B into the Normal Chinrest. 3. Use the Temple Supports OPEN/CLOSE button to widen the Temple Supports. 4. Guide the patient to the equipment. 5. Use the Vertical Frame Up/Down button or switch option to adjust the height of the equipment so that the patient's chin reaches the Chinrest. Green 18 (Model: PHT-65LHS) User Manual ENGLISH 1. 113 9. Acquiring CBCT Images 6. Ask the patient to stand in the center of the equipment and direct them to remain in the position outlined below. ▪ ▪ ▪ ▪ ▪ 7. Use the Temple Supports OPEN/CLOSE button to fit the patient’s head and prevent from moving. 8. Ask the patient to maintain the posture as follows: ▪ 114 Hold the handles tightly. Press the chest against the equipment. Keep both feet close to the inside of the base. Keep both shoulders parallel. Straighten the cervical spine and stand still. Close the eyes. Green 18 (Model: PHT-65LHS) User Manual 9. Acquiring CBCT Images Double Scan (Maxilla) Patient Positioning Remove the Normal Chinrest and Special Bite B. 2. Insert the Double Scan Support into the equipment. ENGLISH 1. Double Scan Support 3. Use the Temple Supports OPEN/CLOSE button to widen the temple supports. 4. Guide the patient to the equipment. 5. Use the Vertical Frame Up/Down button or switch option to adjust the height of the equipment so that the patient's chin reaches the chinrest. Green 18 (Model: PHT-65LHS) User Manual 115 9. Acquiring CBCT Images 6. Ask the patient to stand in the center of the equipment and direct them to remain in the position outlined below. ▪ ▪ ▪ ▪ ▪ 7. Use the Temple Supports OPEN/CLOSE button to fit the patient’s head and prevent from moving. 8. Ask the patient to maintain the posture as follows: ▪ 116 Hold the handles tightly. Press the chest against the equipment. Keep both feet close to the inside of the base. Keep both shoulders parallel. Straighten the Cervical Spine and stand still. Close the eyes. Green 18 (Model: PHT-65LHS) User Manual 9. Acquiring CBCT Images TMJ Patient Positioning Remove the Normal Chinrest and insert the Special Chinrest into the equipment. 2. Insert the Special Bite A into the Special Chinrest 3. Use the Temple Supports OPEN/CLOSE button to widen the temple supports. 4. Guide the patient to the equipment. 5. Use the Vertical Frame Up/Down button or switch option to adjust the height of the equipment so that the patient's chin reaches the chinrest. 6. Ask the patient to stand in the center of the equipment and direct them to remain in the position outlined below. ▪ ▪ ▪ ▪ ▪ ENGLISH 1. Hold the handles tightly. Press the chest against the equipment. Keep both feet close to the inside of the base. Keep both shoulders parallel. Straighten the Cervical Spine and stand still. 7. Use the Temple Supports OPEN/CLOSE button to fit the patient’s head and prevent from moving. 8. Ask the patient to maintain the posture as follows: ▪ Close the eyes. Green 18 (Model: PHT-65LHS) User Manual 117 9. Acquiring CBCT Images Laser Beam Alignment Ensure that the laser beam does not directly enter the patient’s eyes. This may lead to vision loss. Ensure to align the laser beam properly. Distortions can be found in the captured images, such as ghost shadows if the laser beam is not correctly positioned. Vertical Beam / Mid-sagittal plane Horizontal Beam / Frankfurt plane e.g. FOV 16 X 9 This is a sample illustration for reference only. Actual FOV may vary from the image, as shown above. ▪ ▪ 1. The horizontal beam is used to point to the center of the height within the FOV. Unlike in the PANO mode, the horizontal beam does not move in the CT mode. Align the Vertical Beam with the center of the face (Mid-sagittal Line) to prevent the horizontal expansion of the image. Finishing Patient Positioning 118 1. Ensure that the temple supports are at the CLOSE position before clicking the READY button. 2. Click the READY button. X-ray exposure has not started yet. 3. Move to 9.5 X-ray Exposure to start the exposure. Green 18 (Model: PHT-65LHS) User Manual 9. Acquiring CBCT Images 9.5 X-ray Exposure ▪ ▪ ▪ ▪ ▪ ▪ Release the Exposure Switch to stop X-ray emission if an emergency occurs during the imaging acquisition. The operator must follow the X-ray safety regulation and guidelines during the operation. The operator must keep vocal/visual contact with the patient during the image acquisition. Do not operate the PC during exposure. Ask patients to close their eyes during the operation. Ask patients to hold their breath and stop swallowing during the image acquisition. Ask patients to stay in their positions until the Temple Supports are open again. 1. Move out of the X-ray room and close the door. 2. Press and hold down the Exposure Switch until image acquisition is completed. The image appears on the screen. During X-ray exposure, the status appears as follows. ▪ The LED light of the Exposure Switch turns yellow. ▪ The LED light on the top of the equipment turns yellow. ▪ An alert sound comes out to indicate that X-ray emission is currently underway. ▪ On Console Software, the radiation mark turns yellow, and “X-RAY” changes to “X-RAY ON.” 3. Release the Exposure Switch when the “Image capturing is completed” message appears on the screen. Green 18 (Model: PHT-65LHS) User Manual 119 ENGLISH ▪ 9. Acquiring CBCT Images 9.6 9.7 Finishing the Scan 1. Open the temple supports and guide the patient out of the equipment. 2. Remove the sanitary vinyl cover from the normal bite. 3. Press the READY button from Control Panel to bring the rotating unit back to its initial position based on modality. Checking the Captured Images Acquired images can be reconstructed and converted to DICOM format. The exported images can be confirmed in EzDent-i Refer to the EzDent-i User Manual for more information. 120 1. The images are transferred to EzDent-i automatically. 2. The images are automatically saved if the automatic save option is the default. If it is not configured as default, click the Save button to save manually. 3. To check the image, double-click the image on the Patient List. 4. Ez3D-i runs automatically for 3D viewing. Green 18 (Model: PHT-65LHS) User Manual 9. Acquiring CBCT Images ENGLISH This Page is Left Blank Intentionally Green 18 (Model: PHT-65LHS) User Manual 121 10. Acquiring 3D MODEL Scan Images 10. Acquiring 3D MODEL Scan Images 10.1 3D MODEL Scan Imaging Program Overview ◼ Result Images It provides 3D modeling surface data of the Plaster Cast. (STL file) ◼ Image Acquisition Method It acquires images with the X-ray beam scanning the Plaster Cast, reconstructs them to 3D sliced images, and converts them into 3D modeling surface data. ◼ Examination Programs It is classified as below based on the MODEL type. Applied FOV (cm) Vertical Option ROI Description Upper (Maxilla) Captures a whole maxillary Plaster Cast. Lower (Mandible) Captures a whole mandibular Plaster Cast. 8x9 122 Green 18 (Model: PHT-65LHS) User Manual 10. Acquiring 3D MODEL Scan Images 10.2 Setting Exposure Parameters 3D Model Main Window (Console Software) Touch Screen’s Main Window Green 18 (Model: PHT-65LHS) User Manual 123 ENGLISH Complete the steps in 6. Getting Started before setting the exposure parameter on the console. You can also use the touch screen to set the exposure parameters. 10. Acquiring 3D MODEL Scan Images Follow the procedure below to set exposure parameters for the 3D model Scan: 1. Click MODEL from the modality menu. 2. Select Upper or Lower. 3. The patient type is automatically selected by the patient information entered earlier. Confirm or change the patient type by clicking one of the buttons in the patient menu. <Console Software> 4. <Touch Screen> Select the X-ray intensity. <Console Software> 5. <Touch Screen> The system automatically configures the exposure condition based on previous parameters chosen by the user. However, you can customize the preselected condition by using the ( ) button. Each time you click the button, the voltage value is changed by ±1.0 kVp and the current by ± 0.1 mA. <Console Software> 124 <Touch Screen> 6. Click CONFIRM when all parameter settings are completed. 7. Prepare the plaster cast to take the next step (see 10.3 MODEL Positioning) Green 18 (Model: PHT-65LHS) User Manual 10. Acquiring 3D MODEL Scan Images 10.3 MODEL Positioning ENGLISH MODEL Scan Jig Installation 1. Remove the temple supports and the chinrest. 2. Insert the MODEL scan jig. Laser Beam Alignment 1. Put the plaster cast on the MODEL scan jig. (Whether the plaster cast is for maxilla or mandibular, place it flat side down.) 2. Align the mid-sagittal plane laser beam at the center of the plaster cast to prevent the horizontal expansion of the image. 3. Click the READY button. X-ray exposure has not started yet. 4. Move to 10.4 X-ray Exposure to start the exposure Green 18 (Model: PHT-65LHS) User Manual 125 10. Acquiring 3D MODEL Scan Images 10.4 X-ray Exposure Do not operate the PC during exposure. Doing so may cause the system to malfunction. 1. Move out of the X-ray room and close the door. 2. Press and hold down the Exposure Switch until image acquisition is completed. The image appears on the screen. During X-ray exposure, the status appears as follows. ▪ The LED light of the Exposure Switch turns yellow. ▪ The LED light on the top of the equipment turns yellow. ▪ An alert sound comes out to indicate that X-ray emission is currently underway. ▪ On Console Software, the radiation mark turns yellow, and “X-RAY” changes to “X-RAY ON.” 126 3. Release the Exposure Switch when the “Image capturing is completed” message appears on the screen. 4. Remove the plaster cast out of the equipment. Green 18 (Model: PHT-65LHS) User Manual 10. Acquiring 3D MODEL Scan Images 10.5 Checking the Captured Images ENGLISH Acquired images can be reconstructed and converted to DICOM or STL (Stereo Lithography). Refer to the EzDent-i User Manual for more information. 1. The images are transferred to EzDent-i automatically. 2. The images are automatically saved if the automatic save option is the default. If it is not configured as default, click the Save button to save manually. 3. To check the image, double-click the image on the Patient List. 4. You can check the captured image with a 3rd party STL viewer. Green 18 (Model: PHT-65LHS) User Manual 127 11. Troubleshooting 11. Troubleshooting 11.1 Troubleshooting If a problem occurs while operating the equipment, perform the corresponding troubleshooting measures outlined below. If the problem persists, please contact our customer support staff. If the equipment is not working Cause Failure of power supply Actions to be taken Check the equipment’s power supply. Initialization status Wait until the equipment has been initialized, and then try again. Failure of the Control PC's connection Check the Communication Port (Optic) connection status, which connects the PC to the equipment. If the Exposure Switch is not functioning Cause Failure of readiness Actions to be taken Check whether the Console Software is ready for imaging. If imaging cannot be performed Cause Actions to be taken Failure of initialization Wait until the equipment is initialized and then try again. If this problem persists, restart the equipment. If the Laser Beam has shut off and patient positioning cannot be performed 128 Cause Actions to be taken Expiration of the time allotted for patient positioning Press the Laser Beam button to turn on the Laser Beam. Green 18 (Model: PHT-65LHS) User Manual 11. Troubleshooting 11.2 Error Codes Error code is displayed in the format below: [Code: E00X.0XX.0XX] The code consists of three parts: Main code, Subcode, and Tail code. ▪ ▪ ▪ 11.2.1 The main code describes the source of error codes. The source is categorized as hardware, software, an acquisition module, etc. Subcode describes the specific area where the error has occurred according to the main code. The tail code describes the specific symptoms and causes of the errors mentioned in the subcode. Main code - Hardware (001) 11.2.1.1 Subcode – Generator related error (001) Tail code Description 001 Appears when the tube is not ready for use 002 Appears when the cable between the tube tank and Inverter board is disconnected 003 Appears when a current of the inverter board exceeds the maximum allowable level during X-ray irradiation 004 Appears when there is ±10kV or more voltage difference in tube voltage compared to a reference value 005 Appears when there is ±0.5mA or more current difference in tube current compared to a reference value 006 Appears when there is ±20kV or more voltage difference in tube voltage feedback compared to the average value 007 Appears when there is ±1mA or more current difference in tube current feedback compared to the average value 008 Appears when the temperature of the mono tank is above the setting temperature Green 18 (Model: PHT-65LHS) User Manual 129 ENGLISH Error codes appear when the system detects abnormal activities. When you see the error code on the control panel or the console window, contact VATECH for help. 11. Troubleshooting Tail code Description 009 Appears when the inverter output current is higher than 1A during Xray irradiation (In EP, IP condition) 010 Appears when the inverter board falsely recognizes the exposure switch signal as OFF after the irradiation on command 011 Appears when the X-ray OFF command is not sent to the inverter board in 0.5 seconds after turning off the exposure switch 012 Appears when kV feedback is over -20kV compared to the setting value during X-ray irradiation 013 Appears when kV feedback is over +20kV compared to the setting value during X-ray irradiation. 014 Appears when the mA feedback value is less than 50% compared to setting conditions during X-ray irradiation. 015 Appears when the mA feedback value is higher than 150% compared to setting conditions during X-ray irradiation. 11.2.1.2 Sub code - Motor related error (002) Tail code 130 Description 020 Appears when p-axis motor origin movement fails 021 Appears when rotator-axis motor origin movement fails 027 Appears when Cephalo sensor motor origin movement fails 030 Appears when quadruple axis collimator Left origin movement fails 031 Appears when quadruple axis collimator Right origin movement fails 032 Appears when quadruple axis collimator Up origin movement fails 033 Appears when quadruple axis collimator down origin movement fails 037 Appears when generator tilting fails 038 Appears when temple support the motor operation fails 039 Appears when X-axis motor origin movement fails 040 Appears when Y-axis motor origin movement fails Green 18 (Model: PHT-65LHS) User Manual 11. Troubleshooting 11.2.1.3 Subcode – Exposure Switch related error (003) 060 ENGLISH Tail code Description Appears if the exposure switch is pressed when turning on the equipment. 11.2.1.4 Subcode – Other error (004) Tail code 102 11.2.2 Description Appears when there is no response during CAN communication. Main code – Software (002) 11.2.2.1 Sub code – Sequence related error (001) Tail code Description 001 Appears when the packing mode is enabled 002 Appears when the door is open 003 Appears when the exposure switch is pressed 11.2.2.2 Sub code – PC Resolution related error (010) Tail code Description 001 Appears when the resolution is less than 1280x1024 002 Appears when the resolution is less than 1200x960 11.2.2.3 Subcode – PC Network related error (024) Tail code 11.2.3 Description 002 Appears when the port is invalid 003 Appears when the time is out Main code - Acquisition Module (003) 11.2.3.1 Sub code – Initialization Failure related error (010) Tail code Description 000 Appears when the COM port cannot be opened 001 Appears when the frame grabber interface cannot be initialized or memory for acquisition cannot be reserved Green 18 (Model: PHT-65LHS) User Manual 131 11. Troubleshooting Tail code Description 002 Appears when the MCU is not communicable or the modem ring signal is in an improper state 11.2.3.2 Sub code – Capture Failure related error (020) Tail code 000 Description Appears when there is a capture error 11.2.3.3 Sub code – Reconstruction Failure related error (030) Tail code 001 Description Appears when bugs exist in VXM-file or there is insufficient memory 11.2.3.4 Subcode – Hardware related error (061) Tail code HW Error No 132 Description Appears when the error occurs during acquisition module operation Green 18 (Model: PHT-65LHS) User Manual 11. Troubleshooting ENGLISH This Page is Left Blank Intentionally Green 18 (Model: PHT-65LHS) User Manual 133 12. Cleaning and Disinfection 12. Cleaning and Disinfection To prevent product contamination and deformation, clean the equipment and its accessories according to the guidelines in this section. Before you start cleaning or disinfecting the equipment: • Turn off the equipment. • Wear safety gloves. • Select the product that does not contain the following: phenol, acetic acid, peroxide, sodium hypochlorite, isopropyl alcohol (2-propanol, isopropanol), iodine-splitting agents, and oxygen-splitting agents. When you are cleaning or disinfecting the equipment: • Read and follow the instructions written on the cleaning agent’s label. • Do not apply liquids inside the unit. • Do not spray liquid over the surface of the equipment. • Wipe the areas thoroughly after cleaning until no liquid is left. Cleaning with the power still on may lead to serious injury for you and other people around the equipment. VATECH does not recommend or endorse cleaning products. The user's responsibility is to determine what product is adequate to use for cleaning based on FDA and local regulations. Spraying or pouring liquid into the equipment may cause a fire, electric shock, and serious damage to the equipment. 134 Green 18 (Model: PHT-65LHS) User Manual 12. Cleaning and Disinfection 12.1 Cleaning ENGLISH The accessories and parts that have contact with the patient’s mucous membranes must be cleaned between each patient use, including: • Normal / Special A / Special B bite • Temple Supports • Chinrest • Nasal Positioner • Ear Rods When you clean the accessories or the parts, use: • A soft cloth • Chlorine dioxide-based and non-alcoholic cleaning products The following tables describe the proper procedure for each part and accessory: Accessory /Part Bite (Normal / Special A / Special B / Deep Bite*) Temple Supports Chinrest Procedure 1) 2) 3) Remove all visible soil with a paper wipe or disposable cloth. Gently wipe the target areas clean using a soft cloth dampened with a cleaning product. Dry the components or accessories with a paper wipe or clean & dry cloth until no liquid is left. Computer and Peripherals Clean the components following the manufacturer's instructions in the accompanying manual. Outer Covers of Equipment Wipe the covers with a dry cloth once a day. *Deep bite is provided only in Asian countries, including Japan. Do not use abrasive liquids such as acetone, gas, or oil, for they may cause corrosion on the equipment’s surface. Do not use a product that contains silicone. Silicone-based products may damage the equipment’s electrical component. Always dampen the cloth with the cleaning agent. (Do not soak the cloth into liquids. Green 18 (Model: PHT-65LHS) User Manual 135 12. Cleaning and Disinfection 12.2 Disinfection Follow the precautions below when you choose a disinfectant for the equipment. 136 ▪ Use disinfectants that satisfy the national and regional standards. Your region’s regulatory body must approve selected disinfectants for their safety. ▪ Use a disinfectant product for the parts that are frequently touched or come to contact with the patients and staff. ▪ Use a non-alcoholic chlorine dioxide-based disinfectant. ▪ Do not use a UV sterilizer to disinfect the equipment. UV light can discolor the surface of the equipment. ▪ Always follow the direction on the label. Green 18 (Model: PHT-65LHS) User Manual 12. Cleaning and Disinfection ENGLISH This Page is Left Blank Intentionally Green 18 (Model: PHT-65LHS) User Manual 137 13. Maintenance 13. Maintenance VATECH requires periodic constancy tests to ensure image quality and the safety of the patient and the operator. Only VATECH-authorized technicians can perform inspection and service for the equipment. Contact the VATECH service center or your local VATECH representative for technical assistance. 13.1 Regular Maintenance ▪ ▪ ▪ ▪ ▪ 138 Always turn off the equipment before performing any maintenance. Do not remove equipment covers. There are no repairable parts inside. As a precaution against fire, the replacement should be one in the same type and range. There are no user-serviceable parts inside this equipment. Please contact your local VATECH representative if any service is required. ▪ Do not expose the equipment or components in an area susceptible to water or humidity. ▪ Do not expose the equipment in an area of extreme fluctuation in temperature, poor ventilation, direct sunlight, dust, salt, etc. ▪ Keep all detachable components well organized and clean. ▪ Ensure that the equipment is well-grounded. ▪ Do not try to modify this equipment, including the wires or cables. Doing so may damage it beyond repair. Green 18 (Model: PHT-65LHS) User Manual 13. Maintenance 13.1.1 Maintenance Task Checklist Period Before the operation, ensure that the equipment is clean and ready for use. Ensure that all parts that come in direct contact with the patient have been cleaned thoroughly. Daily After using the equipment, ensure that the Main Power Switch has been turned off. Daily Ensure that the plug and the power cord are not heated abnormally. Daily Confirm that the LED indicator turns yellow when the Exposure Switch is pressed. Ensure that the LED indicator remains yellow for the entire duration of the exposure. Daily Ensure that the power cable is not kinked, broken, exposed, and free of all other defects. Daily Confirm that activating the Emergency Stop Switch ceases the unit’s operation. Pressing the Emergency Stop Switch should stop all movement of the equipment and X-ray emission. Weekly Ensure that all visible labels are intact and legible. Weekly Check for possible damages to the Exposure Switch cable. Monthly Confirm that the audio message is audible throughout the exposure. Monthly Green 18 (Model: PHT-65LHS) User Manual 139 ENGLISH Tasks 14. Disposing of the Equipment 14. Disposing of the Equipment This equipment is designed for safe use and disposal. Many components of the equipment, except some parts like the X-ray tube, are environmentally friendly and recyclable. All parts and components of hazardous materials must be disposed of by disposal regulations (IEC 60601-1 6.8.2 j). Parts Materials Recyclable Frame and Covers Aluminum and plastics ● Motors ● Circuit Boards ● Cables and Transformer Copper ● Steel ● Oil Packing To the special disposal site Hazardous waste; Needs Separate Collection ● Wood ● Cardboard ● Paper ● X-ray Tube Sensor Head Other parts ● Return the Sensor Head to VATECH ● This dental equipment shall not be disposed of as domestic garbage materials. Clean / Disinfect / Sterilize the equipment before disassembling it and disposing of its parts. Check all regulations relevant to the disposal of waste in your country. 140 Green 18 (Model: PHT-65LHS) User Manual 14. Disposing of the Equipment ENGLISH This Page is Left Blank Intentionally Green 18 (Model: PHT-65LHS) User Manual 141 15. Technical Specifications 15. Technical Specifications 15.1 Mechanical Specifications 15.1.1 Dimensions (unit = mm) With CEPH unit Without CEPH unit Top view (with Base) Front view (with Base) 142 Green 18 (Model: PHT-65LHS) User Manual 15. Technical Specifications With CEPH unit Without CEPH unit ENGLISH Top view (withou t Base) Front view (withou t Base) [Wall Bracket Dimensions] Front view Green 18 (Model: PHT-65LHS) User Manual Side view 143 15. Technical Specifications Item Description Without CEPH unit 137 kg (302.0 lbs. – without Base) With CEPH unit 162 kg (357.1 lbs. – without Base) Weight Total Height 215 kg (474.0 lbs. – with Base) Without Base Max. 2307.5 mm (90.9”) With Base Max. 2335.5 mm (92.0”) Without CEPH unit Dimensions during operation (Length x Width x Height) With CEPH unit 1155.0 (L) x 1595.8 (W) x 2307.5 (H) (mm, without Base) 45.5 (L) x 62.9(W) x 90.9(H) (inch, without Base) 1155.0 (L) x 1595.8 (W) x 2335.5 (H) (mm, with Base) 45.5 (L) x 62.9 (W) x 92.0 (H) (inch, with Base) 1904.0 (L) x 1595.8 (W) x 2307.5 mm (H) (mm, without Base) 75.0 (L) x 62.9 (W) x 90.9 (H) (inch, without Base) 1904.0 (L) x 1595.8 (W) x 2335.5 (H) (mm, with Base) 75.0 (L) x 62.9 (W) x 92.0 (H) (inch, with Base) Rotating Unit Vertical Movement Max. 800.0 mm (31.5”) Installation Type Base Stand/Wall Mount (Default: Wall Mount type) Packing Box Organization Main Box, CEPH Box (Optional), Base Box (Optional) Image Magnification 15.1.2 144 190 kg (418.9 lbs. – with Base) Mode FDD (mm) FOD (mm) ODD (mm) Magnification PANO 600 477.7 122.3 1 : 1.25 CEPH 1745 1524 221.0 1 : 1.14 CBCT 600 428.6 171.4 1 : 1.40 ▪ FDD: Focal Spot to Detector Distance ▪ FOD: Focal Spot to Object Distance ▪ ODD: Object to Detector Distance (ODD = FDD - FOD) ▪ Magnification = FDD / FOD Green 18 (Model: PHT-65LHS) User Manual 15. Technical Specifications Technical Specifications 15.2.1 X-ray Generator Specifications ENGLISH 15.2 Specifications Item Description Model Generator DG-07E22T2 Rated output power 1.6 kW Inverter model name INV-22 Type Inverter kVp 60 kV ~ 99 kV (1 kV increment) mA 4 mA ~ 16 mA (0.1 mA increment for CBCT, 1.0 mA increment for PANO and CEPH) Normal / Pulse Cooling Tube Cooling Protect (Optional fan cooling ≥ 60℃) Total filtration Min. 2.5 mm Al Default filtration 1.0 mm Al Added filtration 1.5 mm Al (Fixed) / PANO and CEPH mode 1.5 mm Al (Fixed) + 3.0 mm Al (Automatically added) / CBCT mode Manufacturer Canon Electron Tubes & Devices Model D-052SB (Stationary Anode type) Focal spot size 0.5 mm (IEC 60336) Target Angle 5 degree Inherent Filtration At least 0.8 mm Al equivalent at 50 kV X-ray Coverage 95 mm x 380 mm at SID 550 mm Anode Heat Content 35 kJ Duty Cycle 1:60 or more (Exposure time: Interval time) Green 18 (Model: PHT-65LHS) User Manual 145 15. Technical Specifications Test Condition Mode PANO CEPH Tube Voltage (kVp) Tube Current (mA) Exposure Time (s) 60 ~ 90 4 ~ 14 13.5 60 ~ 90 4 ~ 14 11.5 60 ~ 90 4 ~ 14 11.3 60 ~ 90 4 ~ 14 11.1 60 ~ 90 4 ~ 14 9.2 60 ~ 90 4 ~ 14 7.7 60 ~ 90 4 ~ 14 7.0 60 ~ 90 4 ~ 14 6.8 60 ~ 90 4 ~ 14 6.7 60 ~ 90 4 ~ 14 6.1 60 ~ 90 4 ~ 14 5.8 60 ~ 90 4 ~ 14 5.7 60 ~ 90 4 ~ 14 5.2 60 ~ 90 4 ~ 14 5.0 60 ~ 90 4 ~ 14 3.7 60 ~ 90 4 ~ 14 3.5 60 ~ 90 4 ~ 14 3.3 60 ~ 90 4 ~ 14 2.8 60 ~ 90 4 ~ 14 1.4 60 ~ 99 4 ~ 16 1.9 60 ~ 99 4 ~ 15 2.4 60 ~ 99 4 ~ 15 3.9 60 ~ 99 4 ~ 14 4.9 60 ~ 99 4 ~ 14 5.4 60 ~ 99 4 ~ 12 9.0 60 ~ 99 4 ~ 12 4.9 CBCT 146 Green 18 (Model: PHT-65LHS) User Manual 15. Technical Specifications ❚❚ Maximum Rating Charts ENGLISH ❚❚ Emission & Filament Characteristics Green 18 (Model: PHT-65LHS) User Manual 147 15. Technical Specifications ❚❚ Anode Thermal Characteristics ❚❚ X-ray Housing Assembly Tube Characteristics 148 Green 18 (Model: PHT-65LHS) User Manual 15. Technical Specifications 15.2.2 Detector Specifications ENGLISH Description Item Model Detector Type PANO & CBCT CEPH Xmaru1515CF Xmaru2602CF CMOS photodiode array Pixel size 198 µm @ 4X4 binning (49.5 µm @ no binning) 200 µm @ 2x2 binning (100 µm @ no binning) Active area CBCT - 155.2 mm X 145.7 mm PANO - 5.9 mm X 135.8 mm 15.6 mm x 259 mm Frame Rate ~ 95 Hz @ 4X4 binning ~ 330 Hz @ 2x2 binning Analogue-Digital Conversion 14 bits 10 ~ 35 ℃ (Temperature) Operating condition 10 ~ 75 % (Humidity) -10 ~ 60 ℃ (Temperature) Storage condition 10 ~ 75 % (Humidity) Sensor size 188 mm (L) x 247 mm (W) x 32.5 mm (H) 110 mm (L) x 279 mm (W) x 20 mm (H) Sensor weight 1830 g 1050 g Converter Csl : Ti Energy Range 50 ~ 120 kVp Readout Charge amplifier array Video Output Optic MTF > 45 % @ 1 lp/mm, > 10 % @ 2.5 lp/mm > 40 % @ 1 lp/mm > 8 % @ 2.5 lp/mm DQE > 60 % @~0 lp/mm > 70 % @~0 lp/mm Dynamic Range > 80 dB > 70 dB Green 18 (Model:PHT-65LHS) User Manual 149 15. Technical Specifications 15.3 Electrical Specifications Item Power supply voltage Description 100 - 240 V ~ Frequency 50 / 60 Hz Power rating 2.0 kVA Accuracy Tube Voltage (kVp) ± 10 %, Tube Current (mA) ± 20 %, Exposure Time (s) ± (5 % + 50 ms) ▪ The input line voltage depends on the local electrical distribution system. ▪ Allowable input voltage fluctuation requirement: ±10 %. ▪ Mode of operation: non-continuous operation (NFPA 70: long time operation) needs waiting time (at least 60 times the exposure time) before the next exposure begins. ▪ Column operation time: Max. 2 min. On / 18 min. Off (Ratio 1:9) Green18 150 Green 18 (Model: PHT-65LHS) User Manual 15. Technical Specifications ▪ ▪ 15.4 Environmental Specifications Item During Operation Description Temperature 10 ~ 35 ℃ Relative humidity 30 ~ 75 % Atmospheric pressure During Transport and Storage 860 ~ 1060 hPa Temperature -10 ~ 60 ℃ Relative humidity 10 ~ 75 % Atmospheric pressure Green 18 (Model:PHT-65LHS) User Manual 860 ~ 1060 hPa 151 ENGLISH A separate 3-core grounded power cable connected directly to the central distribution panel with an overcurrent circuit breaker rated for 20A must be used to assure line voltage quality. Maximally allowed deviation of the tube voltage/tube current/exposure time: Tube Voltage (kVp) ± 10 % / Tube Current (mA) ± 20 % / Exposure Time (s) ± (5 % + 50 ms) according to IEC 60601-2-63. The mains resistance should not exceed 0.045 ohms at 100 V and 0.19 ohm at 240 V. ▪ 16. Appendices 16. Appendices 16.1 Recommended X-ray Exposure Tables 16.1.1 PANO Mode Exposure Condition Mode Image Option High Resolution Gender / Age group X-ray Intensity Tube Voltage (kVp) Tube Current (mA) Hard 75 12 Man Normal 74 12 Woman Child PANO Examination Man Green (Optional) Woman Child PANO Examination (Insight PAN) (Optional) SPECIAL Examination High Resolution N/A 73 12 74 12 Normal 73 12 Soft 72 12 Hard 68 10 Normal 67 10 Soft 66 10 Hard 75 14 Normal 74 14 Soft 73 14 Hard 74 14 Normal 73 14 Soft 72 14 Hard 68 12 Normal 67 12 Soft 66 12 Man & Woman Normal 70 7 Child Normal 67 7 Hard 75 14 Man Normal 74 14 Woman Child 152 Soft Hard Soft 73 14 Hard 74 14 Normal 73 14 Soft 72 14 Hard 68 12 Normal 67 12 Soft 66 12 Green 18 (Model: PHT-65LHS) User Manual 16. Appendices Scan Time / Exposure Time Arch Type Narrow Normal Wide PANO Examination Child Orthogonal SPECIAL Examination - Green (Optional) Examination Mode Scan Time (s) Exposure Time (s) Scan Time (s) Exposure Time (s) Standard 14.1 13.5 7.0 7.0 Right 14.1 6.8 7.0 3.5 Front 14.1 11.3 7.0 5.8 Left 14.1 6.8 7.0 3.5 Standard 14.1 13.5 7.0 7.0 Right 14.1 6.8 7.0 3.5 Front 14.1 11.3 7.0 5.8 Left 14.1 6.8 7.0 3.5 Standard 14.1 13.5 7.0 7.0 Right 14.1 6.8 7.0 3.5 Front 14.1 11.3 7.0 5.8 Left 14.1 6.8 7.0 3.5 Standard 12.0 11.5 6.8 6.7 Right 12.0 5.7 6.8 3.3 Front 12.0 9.2 6.8 5.2 Left 12.0 5.7 6.8 3.3 Standard 14.1 13.5 7.0 7.0 Right 14.1 6.7 7.0 3.5 Front 14.1 11.1 7.0 5.7 Left 14.1 6.7 7.0 3.5 Bitewings 14.1 9.2 7.0 5.0 Bitewing Incisor (Optional) 14.1 2.8 7.0 1.4 Bitewing Right 14.1 5.0 7.0 2.8 Bitewing Left 14.1 5.0 7.0 2.8 TMJ LAT Open TMJ LAT Close 14.1 6.7 14.1 6.7 Green 18 (Model:PHT-65LHS) User Manual 153 ENGLISH Examination Mode High Resolution 16. Appendices Examination Mode Arch Type Examination Mode TMJ PA Open (Optional) TMJ PA Close (Optional) Sinus LAT (Optional) Sinus PA 154 High Resolution Green (Optional) Scan Time (s) Exposure Time (s) Scan Time (s) Exposure Time (s) 10.0 6.1 10.0 6.1 4.0 3.7 4.0 3.7 8.8 7.7 8.8 7.7 ▪ Scan Time: The actual time that the equipment shoots the patient except for the initial acceleration and late deceleration stages. ▪ Exposure Time: The actual time the patient is exposed to the X-ray emission. Green 18 (Model: PHT-65LHS) User Manual 16. Appendices 16.1.2 CEPH Mode Examination Program Image Option Gender / Age group Man High Resolution Woman Child Lateral Man Green Woman Child Man Full Lateral (Optional) High Resolution / Green Woman Child Green 18 (Model:PHT-65LHS) User Manual X-ray Intensity Tube Voltage (kVp) Tube Current (mA) Hard 92 15.0 Normal 90 15.0 Soft 88 15.0 Hard 90 15.0 Normal 88 15.0 Soft 86 15.0 Hard 88 15.0 Normal 86 15.0 Soft 84 15.0 Hard 92 16.0 Normal 90 16.0 Soft 88 16.0 Hard 90 16.0 Normal 88 16.0 Soft 86 16.0 Hard 88 16.0 Normal 86 16.0 Soft 84 16.0 Hard 92 14.0 Normal 90 14.0 Soft 88 14.0 Hard 90 14.0 Normal 88 14.0 Soft 86 14.0 Hard 88 14.0 Normal 86 14.0 Soft 84 14.0 155 ENGLISH Exposure Condition 16. Appendices Examination Program Image Option Gender / Age group Man High Resolution Woman Child PA SMV Waters’ view Man Green Woman Child Man Carpus High Resolution / Green Woman Child 156 X-ray Intensity Tube Voltage (kVp) Tube Current (mA) Hard 92 14.0 Normal 90 14.0 Soft 88 14.0 Hard 90 14.0 Normal 88 14.0 Soft 86 14.0 Hard 88 14.0 Normal 86 14.0 Soft 84 14.0 Hard 92 15.0 Normal 90 15.0 Soft 88 15.0 Hard 90 15.0 Normal 88 15.0 Soft 86 15.0 Hard 88 15.0 Normal 86 15.0 Soft 84 15.0 Hard 90 6.0 Normal 88 6.0 Soft 86 6.0 Hard 88 6.0 Normal 86 6.0 Soft 84 6.0 Hard 86 6.0 Normal 84 6.0 Soft 82 6.0 Green 18 (Model: PHT-65LHS) User Manual 16. Appendices Scan Time / Exposure Time High Resolution Scan Time Exposure Time (s) (s) Scan Time (s) Green Exposure Time (s) Lateral 3.9 3.9 1.9 1.9 Full Lateral (Optional) 5.4 5.4 3.9 3.9 PA 4.9 4.9 2.4 2.4 SMV 4.9 4.9 2.4 2.4 Waters’ view 4.9 4.9 2.4 2.4 Carpus 4.9 4.9 2.4 2.4 ▪ Scan Time: The actual time that the equipment shoots the patient except for the initial acceleration and late deceleration stages. ▪ Exposure Time: The actual time the patient is exposed to the X-ray emission. Green 18 (Model:PHT-65LHS) User Manual 157 ENGLISH Examination Program 16. Appendices 16.1.3 CBCT Mode Exposure Area Horizontal Position FOV (cm) Vertical Position Right Center Left 18x10 Occlusion X O X Occlusion X O X TMJ O X O Airway X O X Occlusion O O O TMJ O X O Maxilla / Mandible Maxilla / Mandible First Exposure: Mandible Second Exposure: Maxilla O O O 13x10 8x9 8x5 5x5 Double scan (Optional) Right Molar / Right / Incisor / Left / Left Molar X Exposure Condition FOV (cm) Image Option Gender / Age Group Man High Resolution 18x10 & 13x10 & Double scan (Optional) Woman Child Man Green Woman 158 X-ray Intensity Tube Voltage (kVp) Tube Current (mA) Hard 95 8.0 Normal 94 8.0 Soft 93 8.0 Hard 95 7.7 Normal 94 7.7 Soft 93 7.7 Hard 95 7.4 Normal 94 7.4 Soft 93 7.4 Hard 88 6.1 Normal 87 6.1 Soft 86 6.1 Hard 88 5.8 Normal 87 5.8 Green 18 (Model: PHT-65LHS) User Manual 16. Appendices Image Option Gender / Age Group Child Man High Resolution Woman Child 8x9, 8x5, 5x5. Man Green Woman Child Green 18 (Model:PHT-65LHS) User Manual X-ray Intensity Tube Voltage (kVp) Tube Current (mA) Soft 86 5.8 Hard 88 5.5 Normal 87 5.5 Soft 86 5.5 Hard 95 8.0 Normal 94 8.0 Soft 93 8.0 Hard 95 7.7 Normal 94 7.7 Soft 93 7.7 Hard 95 7.4 Normal 94 7.4 Soft 93 7.4 Hard 88 6.1 Normal 87 6.1 Soft 86 6.1 Hard 88 5.8 Normal 87 5.8 Soft 86 5.8 Hard 88 5.5 Normal 87 5.5 Soft 86 5.5 159 ENGLISH FOV (cm) 16. Appendices Scan Time / Exposure Time ▪ ▪ FOV (cm) Scan Time (s) (High Resolution / Green) Exposure Time (s) (High Resolution / Green) Double scan (Optional) 18.0 18.0 18x10 9.0 9.0 13x10 9.0 9.0 8x9 4.9 4.9 8x5 4.9 4.9 5x5 4.9 4.9 Scan Time: The actual time that the equipment shoots the patient except for the initial acceleration and late deceleration stages. Exposure Time: The actual time the patient is exposed to the X-ray emission. Reconstruction Time / File Size (Measured Object: Skull) FOV (cm) Voxel Size (mm) Double scan (Optional) 18x10 13x10 8x9 8x5 5x5 ▪ ▪ 160 Reconstruction Time (s) File Size (MB) Fast HD 0.3 75 - 370 0.2 28 201 779 0.3 19 98 228 0.2 20 118 410 0.3 15 71 122 0.12 21 161 635 0.2 12 57 138 0.12 14 98 359 0.2 9 36 77 0.08 15 115 478 0.12 9 42 411 The above data is obtained from a computer system based on Intel E5-1607 [email protected] (16GB of RAM) and NVIDIA GeForce GTX1060 6GB. Image reconstruction time varies depending on computer specifications and working conditions. Green 18 (Model: PHT-65LHS) User Manual 16. Appendices 16.1.4 3D MODEL Scan Mode ENGLISH Exposure Area FOV (cm) 8x9 Horizontal Position MODEL Type Right Center Left Upper (Maxilla) X O X Lower (Mandible) X O X X-ray Intensity Tube Voltage (kVp) Tube Current (mA) Hard / Normal / Soft 95 8.0 Exposure Condition FOV (cm) 8x9 Gender / Age Group Man / Woman / Child Scan Time / Exposure Time FOV (cm) Scan Time (s) Exposure Time (s) 8x9 9.0 9.0 ▪ Scan Time: The actual time that the equipment shoots the plaster cast except for the initial acceleration and late deceleration stages. ▪ Exposure Time: The actual time that the plaster cast is exposed to the X-ray emission. Reconstruction Time / File Size FOV (cm) Voxel Size (mm) Reconstruction Time (s) File Size (MB) 8x9 0.12 314 706 ▪ The above data is obtained from a computer system based on Intel i7-6700 and NVIDIA GeForce GTX1060 6GB. ▪ Image reconstruction time varies depending on computer specifications and working conditions. Green 18 (Model:PHT-65LHS) User Manual 161 16. Appendices 16.2 X-ray Dose Data 16.2.1 DAP (Dose Area Product) The X-ray dose data is extracted from the X-ray Dose Test Report for Green 18 (PHT65LHS). X-ray Dose Test Report for the Green 18 (PHT-65LHS) maintains dosimetric evaluation that the VATECH dental diagnostic system meets all requirements specified in the IEC Collateral Standard. To limit unnecessary exposure to the patient, operator, or other staff, Green 18 (PHT-65LHS) is designed to comply with IEC 60601-1-3 Part 1 General Requirements for Safety. Test Hardware Brand Name (Model) Green 18 (PHT-65LHS) Sensor Type PANO & CBCT: Xmaru1515CF CEPH: Xmaru2602CF X-ray Generator Tube DG-07E22T2 D-052SB DAP (Dose Area Product) is a quantity used in assessing the radiation risk from diagnostic X-ray examination procedures. It is defined as the absorbed dose multiplied by the area irradiated, expressed in gray square centimeters (mGy·cm2). Despite the limitation, DAP is the best way to predict effective dose value and is currently the most convenient method for patient dose monitoring. 162 Green 18 (Model: PHT-65LHS) User Manual 16. Appendices DAP (Dose Area Product) Calculation ENGLISH When you need more information on DAP measurement procedures or test results for the equipment, please contact VATECH service center or your local VATECH representative and get assistance from VATECH-authorized technicians Measurement Overview Results Mode Exposure Condition DAP [mGy·cm2] PANO Adult Man Normal (High Resolution) 74 kVp / 12.0 mA / 13.5 s 110 PANO Child Normal (High Resolution) 67 kVp / 10.0 mA / 11.5 s 55 PANO Adult Man Normal (Green) 74 kVp / 14.0 mA / 7.0 s 65 PANO Child Normal (Green) 67 kVp / 12.0 mA / 6.7 s 35 CEPH Adult Man LAT (High Resolution) 90 kVp / 15.0 mA / 3.9 s 41 CEPH Child LAT (High Resolution) 86 kVp / 10.0 mA / 3.9 s 38 CEPH Adult Man LAT (Green) 90 kVp / 16.0 mA / 1.9 s 25 CEPH Child LAT (Green) 86 kVp / 16.0 mA / 1.9 s 23 CBCT 18x10 Adult Man (High Resolution) 94 kVp / 8.0 mA / 9.0 s 1865 CBCT 18x10 Adult Man (Green) 87 kVp / 6.1 mA / 9.0 s 1187 CBCT 13x10 Adult Man (High Resolution) 94 kVp / 8.0 mA / 9.0 s 1434 CBCT 13x10 Adult Man (Green) 87 kVp / 6.1 mA / 9.0 s 913 CBCT 8x9 Adult Man (High Resolution) 94 kVp / 8.0 mA / 4.9 s 802 Green 18 (Model:PHT-65LHS) User Manual 163 16. Appendices ▪ 164 Mode Exposure Condition DAP [mGy·cm2] CBCT 8x9 Adult Man (Green) 87 kVp / 6.1 mA / 4.9 s 510 CBCT 8x5 Maxilla/Mandible (High Resolution) 94 kVp / 8.0 mA / 4.9 s 490 CBCT 8x5 Maxilla/Mandible (Green) 94 kVp / 8.0 mA / 4.9 s 307 CBCT 5x5 Maxilla Adult Man (High Resolution) 94 kVp / 8.0 mA / 4.9 s 331 CBCT 5x5 Maxilla Adult Man (Green) 87 kVp / 6.1 mA / 4.9 s 211 CBCT 5x5 Mandible Adult Man (High Resolution) 94 kVp / 8.0 mA / 4.9 s 331 CBCT 5x5 Mandible Adult Man (Green) 87 kVp / 6.1 mA / 4.9 s 211 CBCT Double Scan Adult Man (High Resolution) (Optional) 94 kVp / 8.0 mA / 9.0 s 3730 CBCT Double Scan Adult Man (Green) (Optional) 87 kVp / 6.1 mA / 9.0 s 2374 In Double Scan mode, exposure the FOV 18x10 twice, then stitch the acquired images to provide one image. Green 18 (Model: PHT-65LHS) User Manual 16. Appendices 16.2.2 Leakage Dose Standard National Deviation Terminology Permissive Range International Standard IEC 60601-1-3 Leakage limits leakage at 1M from the source to 100 mR in 1hr Measurement Overview Test Condition ▪ Test mode Tube Voltage (kVp) Tube Current (mA) Exposure Time (s) PANO Adult Man Normal (High Resolution) 99 14.0 13.5 CEPH Adult Man LAT (High Resolution) 99 14.0 3.9 CBCT18x10 Adult Man (High Resolution) 99 12.0 9.0 In Double Scan mode, exposure the FOV 18x10 twice, then stitch the acquired images to provide one image. Green 18 (Model:PHT-65LHS) User Manual 165 ENGLISH X-ray Leakage Dose Test is performed to protect patients against excessive and unnecessary radiation that is not purposed, and this document evaluates the leakage dose amount based on the following standard defined by IEC regulation. It has been performed by covering each collimator region in use. 16. Appendices Results 166 Direction [°] PANO Adult Man Normal (High Resolution) [mR/h] CEPH Adult Man LAT (High Resolution) [mR/h] CBCT 18x10 Adult Man (High Resolution) [mR/h] 0 7.3 5.4 14.6 45 5.8 4.5 8.3 90 1.1 2.8 4.8 135 3.5 4.5 5.2 180 10.5 21.0 11.7 225 22.4 11.8 33.5 270 6.8 18.5 7.4 315 24.5 5.5 48.7 Green 18 (Model: PHT-65LHS) User Manual 16. Appendices 16.2.3 Scattered Dose Measurement Overview Test Condition ▪ Test mode Tube Voltage (kVp) Tube Current (mA) Exposure Time (s) PANO Adult Man Normal (High Resolution) 90 14.0 13.5 CBCT 18x10 Adult Man (High Resolution) 99 12.0 9.0 CEPH Adult Man LAT (High Resolution) 99 14.0 5.4 In Double Scan mode, exposure the FOV 18x10 twice, then stitch the acquired images to provide one image. Green 18 (Model:PHT-65LHS) User Manual 167 ENGLISH X-ray Scattered Dose data concerning different angles and distances are examined for recommendations about appropriate radiation level insignificant zones of occupancy, and the effectiveness of protective shielding facility around the patient’s position. This information states the identity and intended position of the tested phantom and scattered dosimetric evaluation under the defined scope and test circumstances to ensure the magnitude of risks to the operator and staff during both accident situations and routine work. 16. Appendices Results ◼ 168 (PANO / Adult, Man / Normal / High Resolution) Direction [°] 1 m [mR] 1.5 m [mR] 2 m [mR] 0 0.079 0.049 0.021 45 0.039 0.025 0.016 90 0.079 0.050 0.020 135 0.050 0.032 0.013 180 0.162 0.085 0.034 225 0.175 0.082 0.035 270 0.272 0.077 0.031 315 0.224 0.066 0.030 Green 18 (Model: PHT-65LHS) User Manual 16. Appendices ◼ CBCT / 18x10 / Adult, Man / High Resolution 1 m [mR] 1.5 m [mR] 2 m [mR] 0 1.727 0.971 0.482 45 1.817 0.952 0.499 90 0.656 0.170 0.044 135 2.392 1.121 0.525 180 2.541 1.104 0.480 225 2.399 1.095 0.500 270 2.415 1.185 0.581 315 1.874 0.936 0.467 Green 18 (Model:PHT-65LHS) User Manual ENGLISH Direction [°] 169 16. Appendices ◼ ▪ 170 CEPH / Full Lateral / Adult, Man / High Resolution Direction [°] 1 m [mR] 1.5 m [mR] 2 m [mR] 0 0.031 0.021 0.012 45 0.013 0.009 0.003 90 0.011 0.007 0.004 135 0.033 0.006 0.004 180 0.025 0.013 0.004 225 0.045 0.034 0.019 270 - - 0.022 315 0.073 0.048 0.025 Data of 1 m and 1.5 m at 270 ° are not measured since the Ion chamber is located between the generator and the object. Green 18 (Model: PHT-65LHS) User Manual 16. Appendices 16.3 Electromagnetic Compatibility (EMC) Information ENGLISH Guidance and manufacturer’s declaration - electromagnetic emissions The PHT-65LHS is intended for use in the electromagnetic environment specified below. The customer or the user of the PHT-65LHS should assure that it is used in such an environment. Immunity test Compliance Electromagnetic environment - Guidance RF emissions CISPR 11 Group 1 The PHT-65LHS uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions CISPR 11 Class A Harmonic emissions IEC 61000-3-2 Class A Voltage fluctuations / flicker emissions IEC 61000-3-3 Complies The PHT-65LHS is suitable for use in all establishments other than domestic and may be used in domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes, provided the following warning is heeded: Warning: This equipment/system is intended for healthcare professionals only. This equipment/ system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the PHT-65LHS or shielding the location. NOTE) the actual RF shielding effectiveness and filter attenuation of the shielded location must be verified to ensure they meet or exceed the specified minimum values. Green 18 (Model:PHT-65LHS) User Manual 171 16. Appendices Guidance and manufacturer’s declaration - electromagnetic immunity The PHT-65LHS is intended for use in the electromagnetic environment specified below. The customer or the user of the PHT-65LHS should assure that it is used in such an environment. Immunity test IEC 60601-1-2 Test level Compliance level Electromagnetic environment Guidance Electrostatic discharge (ESD) IEC 61000-4-2 ± 8 kV Contact ± 8 kV Contact ± 2 kV, ± 4 kV, ± 8 kV, ±15 kV air ± 2 kV, ± 4 kV, ± 8 kV, ±15 kV air Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Electrical fast transient/burst IEC 61000-44 ±2 kV for power supply lines ±1 kV for input/output lines ±2 kV for power supply lines ±1 kV for input/output lines The main power quality should be a typical commercial or hospital environment. Surge IEC 61000-4-5 ±1 kV line(s) to line(s) ±2 kV line(s) to earth ±1 kV line(s) to line(s) ±2 kV line(s) to earth The main power quality should be a typical commercial or hospital environment. Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-411 0 % UT: 0.5 cycle At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° 0 % UT: 1 cycle and 70 % UT: 25/30 cycles Single-phase: at 0º 0 % UT: 0.5 cycle At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° 0 % UT: 1 cycle and 70 % UT: 25/30 cycles Single-phase: at 0º The main power quality should be a typical commercial or hospital environment. If the user of the PHT-65LHS image intensifier requires continued operation during main power interruptions, it is recommended that the PHT-65LHS image intensifier be powered from an uninterruptible power supply or a battery. Power frequency (50/60 Hz) magnetic field IEC 61000-48 30 A/m 50 Hz/60 Hz 30 A/m 50 Hz/60 Hz Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE Uт is the a.c. Mains voltage before application of the test level. 172 Green 18 (Model: PHT-65LHS) User Manual 16. Appendices Guidance and manufacturer’s declaration - electromagnetic immunity ENGLISH The PHT-65LHS is intended for use in the electromagnetic environment specified below. The customer or the user of the PHT-65LHS should assure that it is used in such an environment. Immunity test IEC 606011-2 Test level Compliance level Electromagnetic environment Guidance Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80MHz V1=3Vrms Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.7 GHz E1=3V/m Portable and mobile RF communications equipment should be used no closer to any part of the PHT-65LHS, including cables, than the recommended separation distance calculated from the equation applicable to the transmitter's frequency. Recommended separation distance: Where P is the maximum output power rating of the transmitter in watts(W) according to the transmitter manufacturer, and d is the recommended separation distance in meters(m). As determined by an electromagnetic site survey, field strengths from fixed RF transmitters should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of the equipment marked with the following symbol: NOTE 1) At 80MHz and 800MHz, the higher frequency range applies. NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. Green 18 (Model:PHT-65LHS) User Manual 173 16. Appendices The PHT-65LHS is intended for use in the electromagnetic environment specified below. The customer or the user of the PHT-65LHS should assure that it is used in such an environment. An electromagnetic site survey should be considered to assess the electromagnetic environment due to fixed RF transmitters. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcasts, and TV broadcasts, cannot be predicted theoretically with accuracy. If the measured field strength in the location where the PHT-65LHS is used exceeds the applicable RF compliance level above, the PHT-65LHS should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the PHT-65LHS. b Over the frequency range 150kHz to 80MHz, field strengths should be less than [V1] V/m. Recommended separation distances between portable and mobile RF communications equipment and the PHT-65LHS This is used in an electromagnetic environment where radiated RF disturbances are controlled. The customer or the user of the PHT-65LHS can help Prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the PHT-65LHS as recommended below, according to the maximum output power of the communications equipment. Separation distance according to the frequency of transmitter [m] IEC 60601-1-2 Frequency of Transmitter 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.7GHz V1=3Vrms E1=3V/m E1=3V/m Separation Distance (meters) Separation Distance (meters) Separation Distance (meters) 0.01 0.116 0.1166 0.2333 0.1 0.368 0.3687 0.7378 1 1.166 1.1660 2.3333 10 3.687 3.6872 7.3785 100 11.660 11.6600 23.333 Equation The rated maximum output power of the transmitter [W] 174 Green 18 (Model: PHT-65LHS) User Manual 16. Appendices ENGLISH This is used in an electromagnetic environment where radiated RF disturbances are controlled. The customer or the user of the PHT-65LHS can help Prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the PHT-65LHS as recommended below, according to the maximum output power of the communications equipment. For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1) At 80MHz and 800MHz, the separation distance for the higher frequency range applies. NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. a. Field strength from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcasts, and TV broadcasts cannot be predicted theoretically with accuracy. An electromagnetic site survey should be considered to assess the electromagnetic environment due to fixed RF transmitters. If the measured field strength in the location where the PHT-65LHS is used exceeds the applicable RF compliance level above, the PHT-65LHS should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the PHT-65LHS b. Over the frequency range 150kHz to 80MHz, field strengths should be less than [V1] V/m. Immunity and Compliance Level Immunity test IEC 60601-1-2 Test level Actual Immunity Level Compliance Level Conducted RF IEC 61000-4-6 3Vrms 150kHz to 80MHz 3Vrms 3Vrms Radiated RF IEC 61000-4-3 3Vrms 80MHz to 2.7GHz 3V/m 3V/m Green 18 (Model:PHT-65LHS) User Manual 175 16. Appendices 16.4 Hand-wrist Image Evaluation References Radiographic Evaluation of Skeletal Maturation. A clinically oriented method based on hand-wrist films. Fishman LS. 1982 The system of Skeletal Maturation Assessment (SMA) The System uses only four stages of bone maturation. All were found at six anatomical sites located on the thumb, third finger, fifth finger, and radius, as seen in Fig.1. Eleven discrete adolescent skeletal maturational indicators (SMI’s), covering the entire period of adolescent development, are found on these six sites (See Fig.1). [Fig1. The site of skeletal maturity indicators] 176 Green 18 (Model: PHT-65LHS) User Manual 16. Appendices Skeletal Maturity Indicators (SMI) [Fig2. Radiographic identification of skeletal maturity indicators] A. The width of the epiphysis as wide as the diaphysis 1. Third finger – a Proximal phalanx 2. Third finger – a middle phalanx 3. Fifth finger – a middle phalanx B. Ossification 1. Adductor sesamoid of thumb C. Capping of epiphysis 1. Third finger – a distal phalanx 2. Third finger – a middle phalanx 3. Fifth finger – a middle phalanx Green 18 (Model:PHT-65LHS) User Manual 177 ENGLISH A system of skeletal maturation assessment based on four stages of bone maturation at six anatomical sites in the hand wrist. 16. Appendices D. Fusion 1. Third finger – a distal phalanx 2. Third finger – a proximal phalanx 3. Third finger – a middle phalanx 4. Radius Eleven Skeletal maturity indicators (SMIs) The System uses only four stages of bone maturation. All were found at six anatomical sites located on the thumb, third finger, fifth finger, and radius, as seen in Fig.1. Eleven discrete adolescent skeletal maturational indicators (SMI’s), covering the entire period of adolescent development, are found on these six sites (See Fig 1.). [Fig3. Eleven Skeletal maturity indicators (SMIs)] A systematic observational scheme, such as that shown in the figure above, can further facilitate SMI evaluation. With this approach, key stages are checked first, rather than looking for maturity indicators in numerical order. A useful step is to determine if the adductor sesamoid of the thumb can be seen (orange circle). If not, then the applicable SMI will be one of those associated with early epiphyseal widening rather than capping. If the sesamoid is visible, then either the sesamoid or an SMI based on capping or fusion will be applicable. 178 Green 18 (Model: PHT-65LHS) User Manual 16. Appendices ENGLISH Green 18 (Model:PHT-65LHS) User Manual 179 16. Appendices 16.5 Acquiring Images for Pediatric Dental Patients 16.5.1 Age Group: Classification Table Ages are classified loosely into the following correspondence between the FDA definition and the one used in this manual. 16.5.2 180 Age Group FDA’s standard VATECH’s Standard Infant 1 month to 2 years N/A Child 2 ~ 12 years of age Child Adolescent 12 ~16 years of age Other 16 ~ 21 years of age Adult > 21 years of age Adult Positioning the Pediatric Dental Patients 1. Use a laser light beam guide to locate the midsagittal plane. The direct patient focuses on mirroring reflection. Affix decal to mirror to aid the patient in maintaining the correct position throughout the exposure. 2. Move the Chinrest into a position that is slightly higher than the patient’s chin height before requesting that the weak place chins onto the rest. Direct the patient to assume a position that resembles the erect stance of a soldier. 3. Direct the patient to stick out the chest while dropping the chin down. While holding the unit handles for stability, direct the patient to take a half step toward the vertical column of the X-ray device into a position that feels as if he/she is slightly leaning backward. 4. Direct the patient to stick out the chest while dropping the chin down. While holding the unit handles for stability, direct the patient to take a half step toward the vertical column of the X-ray device into a position that feels as if he/she is slightly leaning backward. 5. Direct the patient to close lips around the Bite Block during the exposure. 6. Direct the patient to swallow and note the flat position of the tongue. Request that the patient sucks in the cheeks, pushing the tongue into the correct flat position against the palate, and maintain this position throughout the exposure. Green 18 (Model: PHT-65LHS) User Manual 16. Appendices <How to produce error-free radiographic images for the pediatric patient> ENGLISH (http://www.dimensionsofdentalhygiene.com/print.aspx?id=3612) - By Evelyn M. Thomson, BSDH, MS Panoramic radiographs are often recommended for assessing the growth and development of the pediatric patient and for evaluation of developing third molars during adolescence.1-3 While the panoramic technique seems relatively straightforward, producing a diagnostic quality image of the pediatric patient requires a mastery of technical skills.4 Modern panoramic x-ray equipment is designed for ease of use, yet studies continue to demonstrate a high incidence of errors.5-7 Positioning errors may occur at an even higher rate in pediatric panoramic radiographs.7 The goal of the dental hygienist is to maximize the use of panoramic imagery in the assessment of the pediatric patient while minimizing the occurrence of retakes that result from the radiographic error. Producing A Quality Panoramic Image A quality panoramic radiograph should image all of the teeth, erupted and unerupted, in both the maxillary and mandibular arches from condyle to condyle in the horizontal dimension, and from the superior third of the orbit in the superior region to the inferior border of the mandible in the inferior region.8,9 The arches should appear straight or slightly U-shaped with the occlusal plane parallel to the horizontal edges of the film (Figure 1). The anterior teeth must not be magnified or diminished in size, and overlapping of adjacent posterior teeth should be kept to a minimum. The most critical component in producing a diagnostically acceptable panoramic image is patient positioning. All panoramic x-ray machines have guidelines to assist with positioning the dental arches within the three dimensions of the focal trough, an Green 18 (Model:PHT-65LHS) User Manual 181 16. Appendices area where the anatomical structures will be imaged in relative clarity. Most panoramic x-ray machines have a bite block to indicate the correct anterior-posterior position, or how far forward or back the patient should be positioned, side positioner guides for determining the correct lateral alignment, and chin rest to correctly locate the superiorinferior dimension or how far up or down the chin should be positioned.4,10 Panoramic x-ray machines are available with a mirror and laser light beam guide that shoots on the patient's face to illustrate various anatomical planes (Figure 2). Incorrectly positioning the patient in any of these three dimensions will produce unique and distinct radiographic image errors (Table 1). 182 Green 18 (Model: PHT-65LHS) User Manual 16. Appendices Anterior-Posterior Positioning Error or ghosting of the anterior anatomy occurs. Unerupted teeth in the anterior region may not be imaged on the radiograph if positioned outside of the focal trough. It is important to note that an error of only 3 mm to 4 mm in either direction will result in a significantly compromised image.11 When the arches are positioned too far anterior, the anterior teeth will appear narrow and diminished in size. The vertebrae of the spinal column may be superimposed over the condyles at the edges of the film and, depending on the size of the child, may be superimposed over the rami of the mandible, blocking a clear view of the posterior teeth (Figure 3). When the arches are positioned too far posteriorly, the anterior teeth will appear broad or widened. If the position is excessively posterior, anterior teeth may be blurred entirely from the image, and the condyles may be cut off from the edges of the film. To avoid these imaging errors, the anterior teeth must occlude edge-to-edge onto the designated area of the bite block. Achieving this position is easily compromised during exfoliation of primary teeth, making precise occlusion difficult when one tooth or multiple teeth are missing or partially erupted. A cotton roll may be attached to the bite block to fill in the space created by the missing tooth or teeth. Additionally, an adjustment may be necessary when using a laser light beam guide. The manufacturer's instructions for directing the laser light beam at a predetermined tooth or interproximal space usually apply to adult patients. These instructions may need to be modified for the pediatric patient with primary or mixed dentition. Green 18 (Model:PHT-65LHS) User Manual 183 ENGLISH When the arches are positioned incorrectly in the anterior-posterior direction, distortion 16. Appendices Lateral Left-Right Positioning Error When the arches are positioned incorrectly in the lateral left-right dimension, the posterior teeth on one side will appear broad or widened, while the teeth on the other side will appear narrowed or diminished in width and severely overlapped (Figure 4). This image distortion is like that which occurs with an incorrect anterior-posterior position. When the arches are rotated or tilted, the posterior teeth on one side move out of the focal trough to a position further away (back) from the image receptor, while the opposite side simultaneously moves closer (forward) to the image receptor. Depending on the severity of rotation or tilting, the inferior border of the mandible will appear distorted, and the condyles and rami will appear asymmetrical. To avoid imaging errors that result from incorrect lateral positioning, the midsagittal plane must be positioned perpendicular to the floor. Most panoramic x-ray machines have a head positioner and laser light beam guide, along with a mirror, to assist in determining the correct lateral head position. The pediatric patient may need additional instructions to maintain the correct position throughout the exposure. The movement of the tube head during exposure may pique the pediatric patient's curiosity, causing the head to rotate as the eyes follow the movement of the tube head. A vertical line decal affixed to the mirror can serve as a visual aid and a focus point. An eye-catching sticker, such as those purchased from a craft store, can be adhered to the mirror in a position that aligns with the midsagittal plane. The patient can be directed to position the head so that the sticker appears at the tip of the nose and to maintain focus on this reflection throughout the exposure. Pediatric patients may find looking at themselves in the mirror entertaining and a fun way to participate in the process.9 184 Green 18 (Model: PHT-65LHS) User Manual 16. Appendices Superior-Inferior (Up-Down) Positioning Error focal trough can be challenging to achieve, especially with children whose smaller size reduces the distance between the shoulders and the inferior border of the chin. When the arches are positioned incorrectly in the superior-inferior direction, the image exhibits multiple distortions, including increased overlap in the premolar regions. When the arches are positioned too far up or down, the teeth will simultaneously move into a position that is too far back or too far forward, respectively, out of the focal trough.11 Positioning the arches too far superiorly produces a characteristic "frown" or flat, downward-turned appearance to the occlusal plane (Figure 5). The condyles flare out and off the edges of the image, and the palate appears as a widened, thick, dense radiopacity. This positioning error results in a widened appearance of the palate and obliterates the apical regions of the maxillary teeth, compromising the images of the unerupted developing dentition. As the maxillary arch tips upward, the anterior teeth tilt backward, producing the same widened appearance that results from an incorrect anterior-posterior position. Positioning the arches too far inferior produces a characteristic "smile" appearance or the upward curve of the occlusal plane, with the condyles tilting inward toward the center of the image (Figure 6). Depending on the severity of the downward position, the vertebrae may also curve inward and appear superimposed over the condyles, and the hyoid bone may be superimposed over the mandible blocking a clear view of the erupted and unerupted mandibular teeth. Green 18 (Model:PHT-65LHS) User Manual 185 ENGLISH Positioning the dental arches within the superior-inferior (up-down) dimension of the 16. Appendices Correct positioning of the arches in the superior-inferior dimension requires that the patient stands with erect posture while tucking the chin in and down slightly, a direction that both adults and pediatric patients often find difficult to follow without specific guidance. The result is often a slumped position with the patient hunching the neck and shoulders over to place the chin on the chin rest. The vertebrae collapse causing attenuation of the x-ray beam that produces a triangular radiopacity superimposed over the mandible, and if severe, over the anterior maxillary regions as well. Depending on the manufacturer, panoramic x-ray machines direct the operator to position the Frankfort or the canthomeatal plane parallel to the floor, or the ala-tragus line 5° down toward the floor. This is achieved by raising or lowering the chin rest so that the appropriate landmark lines up with indicators on the machine (Figure 2). The patient should be directed to stand in front of the panoramic x-ray machine allowing the operator to place the chin rest in a position that is slightly higher than the patient's chin. The patient is then requested to move into the overhead assembly of the machine and remain standing tall. If further adjustment is needed, it is usually to a lowered chin position. Once the patient's chin is resting on the chin rest, it is easier to move to a lower position than to a higher one. To assist with placing the chin on the chin rest while maintaining an erect posture, the pediatric patient can be directed to stand like a soldier. Most children are familiar with the straight back, chest forward tucked chin position demonstrated by military persons, and can readily mimic this stance. Further Recommendations Before beginning the exposure, the patient should be directed to close the lips around the bite block and to place the tongue against the palate. Leaving the lips open will create a soft tissue shadow across the teeth that that can be mistaken for caries.7 Leaving the tongue at rest during the exposure allows the radiation to easily penetrate the space of the oral cavity between the dorsal surface of the tongue and the palate, 186 Green 18 (Model: PHT-65LHS) User Manual 16. Appendices producing a radiolucent shadow that diminishes the diagnostic quality of the "Filling in" this space with the soft tissue of the tongue can increase the quality of the image by diminishing this radiolucent shadow. When directed to place the tongue on the roof of the mouth, the pediatric patient is likely to press only the tip of the tongue against the palate. While an adult patient can usually understand what is required when directed to swallow and note the position of the tongue, a child may be directed to suck in the cheeks, which results in pushing the tongue into a position flat against the palate.7 Conclusion In addition to these guidelines for producing error-free radiographic images for pediatric patients, panoramic machines should be evaluated periodically for accuracy. Changes may occur over time to the focal trough that interferes with the diagnostic quality of the machine.6 If a decrease in image quality is noted despite following accurate patient positioning steps, the panoramic x-ray machine should be inspected, and the focal trough recalibrated. The dental hygienist who is skilled in understanding general equipment operation and pediatric patient management is more likely to produce radiographic images that result in higher diagnostic yields. References 1. Public Health Service, Food and Drug Administration, American Dental Association Council on Dental Benefits Program, Council on Dental Practice, Council on Scientific Affairs. The Selection of Patients for Dental Radiographic Examinations. Washington, DC: United States Department of Health and Human Services; 1987 (revised 2005):1-23. 2. Pinkham PS, Casamassimo, Fields HW, McTigue DJ, Nowak AJ. Pediatric Dentistry Infancy Through Adolescence. 4th ed. St. Louis: Elsevier Saunders; 2005:677. 3. Thomson EM. Panoramic radiographs and the pediatric patient. Dimensions of Dental Hygiene. 2008;6(2):26-29. 4. Rushton VE, Rout J. Panoramic Radiology. London: Quintessence Publishing Co Ltd; 2006:17, 84-85. 5. Kullman L, Joseph B. Quality of digital panoramic radiography in a newly established dental school. Swedish Dent Journal. 2006; 30: 165-170. 6. Akarslan ZZ, Erten H, Güngör K, et al. Common errors on panoramic radiographs taken in a dental school. J Contemp Dent Pract. 2003; 4:24-34. 7. Rushton VE, Horner K, Worthington HV. The quality of panoramic radiographs in a sample of general dental practices. Br Dent J. 1999; 26: 630-633. Green 18 (Model:PHT-65LHS) User Manual 187 ENGLISH radiograph (Figure 3). 16. Appendices 8. White SC, Heslop EW, Hollender LG, Mosier KM, Ruprecht A, Shrout MK. Parameters of radiologic care: an official report of the American Academy of Oral and Maxillofacial Radiology. Oral Surg Oral Med Oral Pathol. 2001; 91:498-511. 9. McDonald RE, Avery DR, Dean JA. Dentistry for the Child and Adolescent. 8th ed. St. Louis: Elsevier Mosby; 2000:71-72. 10. Johnson ON, Thomson EM. Essentials of Dental Radiography for Dental Assistants and Hygienists. 8th ed. Upper Saddle River, NJ: Prentice-Hall 2007:388-397. 11. Serman N, Horrell BM, Singer, S. High-quality panoramic radiographs. Tips and tricks. Dentistry Today. 2003;22(1):70-73. Setting Exposure Values to the Age Group 16.5.3 For more information about this topic, refer to the Appendices 16.1 Recommended XRay Exposure Table. The References Pertinent to the Potential Risks for the Pediatric Patients 16.5.4 1) Literature ▪ I. ESPELID, I. MEJÀRE, K. WEERHEIJM: EAPD guidelines for the use of radiographs in children, P40-48. European Journal of Pediatric Dentistry 1/2003 Guidelines in dental radiology are designed to avoid unnecessary exposure to X-radiation and to identify individuals who may benefit from a radiographic examination. Every prescription of radiographs should be based on an evaluation of the individual patient's benefit. Due to the relatively high frequency of caries among 5-year-old children, it is recommended to consider dental radiography for each child even without any visible caries or restorations. Furthermore, radiography should be considered at 8-9 years of age and then at 12-14, which is 1-2 years after the eruption of premolars and second molars. Additional bitewing controls should be based on an overall assessment of the caries activity/risk. The high-risk patient should be examined radiographically annually, while a 2-3 year interval should be considered when caries activity/risk is low. A routine survey by radiographs, except for caries, has not been shown to provide enough information to be justified considering the balance between cost (radiation and resources) and benefit. ▪ 188 MICHAEL L. TAYLOR, B.SC. TOMAS KRON, PH.D., AND RICK D. FRANICH, PH.D.: Green 18 (Model: PHT-65LHS) User Manual 16. Appendices ASSESSMENT OF OUT-OF-FIELD DOSES IN RADIOTHERAPY OF BRAIN 1–7, 2010 To characterize the out-of-field doses in pediatric radiotherapy and to identify simple methods by which out-of-field dose might be minimized, to reduce the risk of secondary cancers Out-of-field doses to pediatric patients can be minimized by using simple treatment ▪ C. THEODORAKOU, K. HORNER, K. HOWARD, A. WALKER: Pediatric organ and effective doses in dental cone beam computed tomography Dental CBCT has been associated with higher radiation risk to the patients compared to conventional dental X-ray imaging. Several studies have investigated the radiation doses involved in dental CBCT for adults, but none has investigated pediatric doses. This study estimates the organ and effective doses to two pediatric tissue-equivalent phantoms using thermoluminescent dosimeters for three dental CBCT units and six imaging protocols. The doses to the thyroid, salivary glands and brain ranged from 0.068mSv to 1.131mSv, 0.708mSv to 2.009mSv and 0.031mSv to 1.584mSv respectively. The skin and red bone marrow have received much lower doses than the other three organs. The effective doses ranged from 0.022 mSv to 0.081 mSv. The effective doses calculated in this study were much higher than these of panoramic X-ray imaging but lower than conventional CT ▪ CHIYO YAMAUCHI-KAWAURA & KEISUKE FUJII & TAKAHIKO AOYAMA & SHUJI KOYAMA & MASATO YAMAUCHI: Radiation dose evaluation in the head and neck MDCT examinations with a 6year-old child anthropomorphic phantom, Pediatr Radiol (2010) 40:1206–1214 DOI 10.1007/s00247-009-1495-z Background: CT examinations of the head and neck are the most commonly performed CT studies in children, raising concerns about radiation dose and their risks to children. Objective: The purpose of this study was to clarify radiation dose levels for children 6 years of age undergoing head and neck multi-detector CT (MDCT) examinations. Materials and methods: Radiation doses were measured with small-sized silicon photodiode dosimeters that were implanted at various tissue and organ positions within a standard 6-year-old anthropomorphic phantom. Organ and effective Green 18 (Model:PHT-65LHS) User Manual 189 ENGLISH LESIONS IN CHILDREN, Int. J. Radiation Oncology Biol. Phys., Vol. -, No. -, pp. 16. Appendices doses of brain CT were evaluated for 19 protocols in nine hospitals on various (2– 320 detector rows) MDCT scanners. Results: The maximum value of the mean organ dose in brain CT was 34.3 mGy for the brain. Maximum values of mean doses for the radiosensitive lens and thyroid were 32.7 mGy for a lens in brain CT and 17.2 mGy for thyroid in neck CT. The seventy-fifth percentile of effective dose distribution in brain CT was approximately the same as the diagnostic reference level (DRL) in the 2003 UK survey. 2) Website For additional information on pediatric X-ray imaging, please refer to the websites below. 190 ▪ http://www.fda.gov/radiationemittingproducts/radiationemittingproductsandprocedures/medicalimaging/ucm29 8899.htm ▪ http://www.imagegently.org/ Green 18 (Model: PHT-65LHS) User Manual 16. Appendices 16.6 Abbreviations Alternating Current CAN Controlled Area Network CBCT Cone-Beam Computed Tomography CMOS Complementary Metal-Oxide -Semiconductor CT Computed Tomography DAP Dose Area Product DC Direct Current DICOM Digital Imaging and Communications in Medicine EMC Electromagnetic Compatibility ENT Ear, Nose, and Throat ESD Electrostatic Discharge FDD Focal spot to Detector Distance FOD Focal spot to Object Distance FOV Field of View IEC International Electrotechnical Commission ISO International Standards Organization LCD Liquid Crystal Display LED Light-Emitting Diode MPSO Multiple Portable Socket-Outlet ODD Object to Detector Distance PA Posterior / Anterior RF Radio Frequency ROI Region of Interest Green 18 (Model:PHT-65LHS) User Manual ENGLISH AC 191 16. Appendices 192 SID Source to Image Receptor Distance SIP Signal Input Part SOP Signal Output Part SMV Submento-Vertical STL Stereo Lithography TMJ Temporomandibular Joint Green 18 (Model: PHT-65LHS) User Manual Copyright by © 2017 VATECH Co., Ltd. All rights reserved. The documentation, brand name, and logo used in this manual are copyrighted. No part of this manual may be reproduced, transmitted, or transcribed without the expressed written permission of the manufacturer. We reserve the right to make any alterations that may be required due to technical improvement. For the most current information, contact your VATECH representative. Tel: +82-1588-9510 Email: [email protected] Website: www.vatech.com Headquarters: 13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggi-do, 18449, Korea Factory: 13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggi-do, 18449, Korea The CE symbol grants this product compliance to the European Directive for Medical Devices 93/42/EEC as amended by 2007/47/EC as a class IIb device. EU Representative; VATECH GLOBAL FRANCE SARL 49 Quai de Dion Bouton, AVISO A 4ème étage, 92800 Puteaux, France Tel: +33 1 64 11 43 30 Fax: +33 1 64 11 43 39 Australia Sponsor; VATECH Medical Pty Ltd. ABN: 78 155 258 923 Address: Suite 5.04 Gateway Business Park 63-79 Parramatta Road, Silverwater, NSW 2128 Tel: 1300 789 454 (+61 2 9644 4866) E-mail: [email protected] ">
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