Vatech PaX-i3D Smart User Manual
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Vatech PaX-i3D Smart User Manual

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Postal Code: 445-170
13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggi-do, Korea

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Summary of Contents for Vatech PaX-i3D Smart

  • Page 1 Postal Code: 445-170 13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggi-do, Korea...
  • Page 2 (PHT-30LFO) English User Manual Version 1.2.0...
  • Page 3 "i" stands for 'innovation', one of the core values of VATECH, which aims to expand accessibility of medical solutions to more people.
  • Page 4 The PaX-i3D Smart is an advanced digital dental diagnostic system that incorporates PANO, CEPH, and CBCT imaging capabilities into a single system. This manual describes how to operate the PaX-i3D Smart system. It is recommended that you thoroughly familiarize yourself with this manual in order to make the most effective use of this equipment.

  • Page 5: Table Of Contents

    Running the Image Viewer .................. 44 Initiating the Console Software ................50 6. Acquiring PANO images ..............54 Setting Exposure Parameters ................59 Patient Positioning ....................63 X-ray Exposure ....................77 Finishing Scan ....................78 Confirming Image ....................78 vi I PaX-i3D Smart...

  • Page 6: Table Of Contents

    13. Appendices ..................132 13.1 Recommended X-ray Exposure Table ............... 132 13.2 X-ray Dose Data ....................135 13.3 Electromagnetic Compatibility (EMC) Information ..........139 13.4 Acquiring image for the pediatric dental patient ..........142 13.5 Abbreviations ....................145 vii I PaX-i3D Smart...

  • Page 8: General Information

    General Information Manufacturer’s Liability .....2 Owner and Operator’s Obligations ..2 Conventions in this Manual ....3 Marks and Symbols ......4...
  • Page 9 ● Genuine VATECH approved equipment and components have been used at all times. ● All maintenance and repairs have been performed by a VATECH authorized agent. ● The equipment has been used normally in accordance with the user’s manual. ● The equipment damage or malfunction is not the result of an error on the part of the owner or operator.

  • Page 10: Conventions In This Manual

    Indicates a situation or action that could potentially IMPORTANT cause problems to the equipment and/or its operation. Emphasizes important information or provide NOTE useful tips and hints. Indicates a component which must be replaced for SINGLE USE each new patient. PaX-i3D Smart...

  • Page 11: Marks And Symbols

    This symbol warns ESD hazard. package This symbol indicates that this equipment is classified as a CLASS 1 LASER PRODUCT in accordance with IEC Label CLASS 1 LASER PRODUCT 60825-1 ED.1 regulations. Date of manufacture Label Refer to Instruction manual Label PaX-i3D Smart...

  • Page 12: Warnings And Precautions

    Warnings and Precautions General Safety Precautions ....6 Electricity-related Safety Precautions 9 Radiation Safety ......11 Warnings .........12...
  • Page 13 ● Do not push or pull the equipment. If equipment overbalances, resulting in the risk of physical injuries or property damage. ● Operators must ask the patient to remain still until the equipment arm has stopped moving and the reset motion is complete. PaX-i3D Smart...
  • Page 14 ● If this product is exposed to water, moisture, or a foreign substance, immediately turn off all power to the equipment and contact your VATECH technical support representative. ● Immediately cease all operation of this equipment if there are signs of oil leakage and contact you VATECH technical support representative.
  • Page 15 ● Do not position the patient in 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 mechanism while adjusting the height of the equipment. PaX-i3D Smart...

  • Page 16: Electricity-Related Safety Precautions

    ● No part of this equipment is serviceable by the user. All maintenance and repair of this equipment must be performed by a qualified service technician. ● This product may only be operated with original VATECH accessories or third-party accessories expressly approved by VATECH.
  • Page 17 Please also observe the ESD (ESD: Electro-Static Discharge) protective measures described below. ❚ Static Discharge ● Connector pins or sockets bearing ESD warning labels must not be touched or interconnected without observing ESD protective measures. Electrostatic discharge (ESD) 10 I PaX-i3D Smart...

  • Page 18: Radiation Safety

    ● This equipment must be housed inside an X-ray shielded room. ● During imaging; the operator must maintain 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. 11 I PaX-i3D Smart...
  • Page 19 ● 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. 12 I PaX-i3D Smart...
  • Page 20 Dental X-ray system. ● PaX-i3D Smart system is designed to withstand the effects of defibrillation. However, when possible, disconnect the Dental X-ray systems during defibrillation since a malfunction of the safety controls could otherwise result in electrical burns for the patient.
  • Page 21 ● The use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by the VATECH of the medical electrical equipment or medical electrical system as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of EQUIPMENT or SYSTEM.
  • Page 22 ● The software can be updated by the manufacturer only. Unauthorized software update through a third party, not the manufacturer, is strictly prohibited. For cyber security issues related to the software and medical devices, please contact the manufacturer. 15 I PaX-i3D Smart...

  • Page 24: Imaging System Overview

    Imaging System Overview 3.1 Introduction ......18 3.2 Imaging System Configuration ..........21 3.3 Equipment Overview .....23...

  • Page 25: Intended Use

    3. Imaging System Overview 3.1 Introduction PaX-i3D Smart is an advanced digital dental diagnostic system that incorporates Panoramic (PANO), Cephalometric (CEPH), and CBCT imaging capabilities into a single system. 3.1.1 Intended Use PaX-i3D Smart(PHT-30LFO) is a computed tomography x-ray system intended to...
  • Page 26 3.1.5 Standards and Regulations ❚ Standards PaX-i3D Smart was designed and developed to comply with the following international standards and regulations. IEC/EN 60601-1(3rd), UL 60601-1(1st), IEC/EN 60601-1-3, IEC 60601-2-63 21 CFR 1020.30, 31, 33 NEMA Standard publication PS 3.1-3.18, 2008...
  • Page 27 3. Imaging System Overview ❚ Classification (IEC60601-1 6.1) ● Degree of protection against the ingress of water: Ordinary Equipment: IPX0 ● Degree of protection against electric shock: Class 1 equipment, Type B Applied Parts 20 I PaX-i3D Smart...

  • Page 28: Imaging System Configuration

    3. Imaging System Overview 3.2 Imaging System Configuration PaX-i3D Smart Fiber Optice Cable 10m(32.8'): SCAN CEPH(Optional) Fiber O Ethernet Cable(CAT5e): OneShot CEPH(Optional) Etherne Exposure switch Fiber Optic Cable 10m(32.8'): PANO, CT Fiber O SIGNAL INPUT WARNING SYSTEM BOX LAMP INPUT...
  • Page 29 3. Imaging System Overview ❚ PC Signal Input / Output Parts 3D Viewer License Key Video out Fiber optic cable in / out x 2 (PANO/CT, CEPH) Ethernet cable(CAT5e) for OneShot CEPH(optional) 22 I PaX-i3D Smart...

  • Page 30: Equipment Overview

    3. Imaging System Overview 3.3 Equipment Overview Scan CEPH Oneshot CEPH 23 I PaX-i3D Smart...
  • Page 31 Balances the equipment and maintains its safety. Stationary Column A fixed column. Operates the horizontal beam, opens/closes temple supports, and adjusts the height of the vertical frame Control Panel and prepares for operation when the Ready button is pressed. 24 I PaX-i3D Smart...
  • Page 32 Temple Supports Patient head support: Use in PANO and CBCT modes. X-ray Sensor PANO / CBCT Sensor (PANO/CT) Indicates the emission status while the x-ray is in operation. LED Lamp - Green: Ready - Orange: X-ray ON 25 I PaX-i3D Smart...

  • Page 33: Control Panel

    Temple Support OPEN/CLOSE Adjusts the temple supports to position the patient. button When pressed, prepares for operation after positioning the patient and configuring the READY/ RETURN environment settings. button Initializes the positioning of the rotating unit. 26 I PaX-i3D Smart...
  • Page 34 If a problem occurs during image acquisition, press the red Emergency Stop Switch to immediately stop the moving parts and cut off all power to the equipment’s electrical components. To reset the Emergency Stop Switch, turn it clockwise until it pops up. 27 I PaX-i3D Smart...
  • Page 35 Exposure Switch X-ray Exposure LED ● Green: Standby (X-ray Off) ● Orange: Run (X-Ray On) The exposure switch is detachable. Ensure the exposure switch cable is not pulled out from the unit accidentally during operation. 28 I PaX-i3D Smart...
  • Page 36 Integrated Chin Rest: TMJ, Sinus Ear Rod (1 set) Nasal Positioner Cover (for CEPH) Carpus Plate Integrated Chin Rest Sanitary Vinyl Panorama Cover Covers (disposable): Bite Block 300 pcs Protractor (1 set): Use to position the body in CEPH mode. 29 I PaX-i3D Smart...

  • Page 38: Imaging Software Overview

    Imaging Software Overview 4.1 PC Specifications ....32 4.2 EasyDent / EzDent-i .....34 4.3 Console Software ....35...

  • Page 39: Easydent / Ezdent-I

    1 PCI Express Gen3 x 16 slot (x4 Electrical) Slots 1 PCI Express Gen2 x 8 slot 1 PCI Express Gen2 x 4 slot 1 PCI Express Gen2 x 4 slot 1 PCI slot 1 PCI slot 32 I PaX-i3D Smart...
  • Page 40 LENOVO DVD-ROM, DVD+/-RW, Blu- DVD-ROM DVD R/W, Blu-Ray CD/DVD drive 19” 1280 x 1024 screen 19” 1280 x 1024 screen Monitor resolution resolution Windows 7 Professional Windows 7 Professional Operating system 64-Bit 64-Bit Recommended Z420 system 33 I PaX-i3D Smart...

  • Page 41: Console Software

    4. Imaging Software Overview 4.2 EasyDent / EzDent-i EasyDent / EzDent-i is dental imaging software from Vatech Co. Ltd that manages patient images so you can make faster, more accurate diagnoses. The console software and 3D Viewer are linked with EasyDent / EzDent-i making it convenient for the user to use and process necessary images.
  • Page 42 ● To improve program functions, the console software may change without notice. The main screen of the Console Software consists of the following. Each one of the different modes will be described later.    35 I PaX-i3D Smart...
  • Page 43 If necessary, adjust the kVp and mA Tube Voltage and values manually using the arrows. Current Adjustment For the tube voltage and its correspondence with the current patient, refer to Appendix > 13.1 Recommended X-ray Exposure Table. 36 I PaX-i3D Smart...
  • Page 44 Soft ≤ Normal ≤ Hard Classification Average head Range of head Group circumference (cm) X-ray intensity circumference > 53±3 Hard Child 53±3 cm 53±3 Normal 53±3 < Soft > 56±3 Hard Adult 56±3 cm 56±3 Normal 56±3 < Soft 37 I PaX-i3D Smart...
  • Page 45 This Control Panel displays and sets various equipment-related parameters, including Settings language, automatic save, DAP display unit, etc. This button exits the capturing program. Exit This selects an imaging mode – PANO, CEPH or Imaging Mode CBCT. 38 I PaX-i3D Smart...
  • Page 46 Product) value will be shown on the main display for the exposure you are going to take. This button is used when all aspects of preparation have done for image acquisition READY (including parameter settings and patient positioning) 39 I PaX-i3D Smart...

  • Page 48: Getting Started

    Getting Started 5.1 Turning On Equipment ..42 5.2 Running the Image Viewer ..44 5.3 Initiating the Console Software ..........50...
  • Page 49 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 the equipment and PC correctly installed. 42 I PaX-i3D Smart...
  • Page 50 ON ( I ) ON ( I ) 3. Confirm the green LED light at the top of the equipment is on. 4. Plug the license key for the 3D viewer into the PC. License Key 43 I PaX-i3D Smart...

  • Page 51: Running The Image Viewer

    5. Getting Started 5.2 Running the Image Viewer EasyDent / EzDent-i is a basic imaging platform for all VATECH’s dental X-ray equipments. The Imaging Program is interfaced with EasyDent / EzDent-i. On your desktop, double-click EasyDent / EzDent-i icon. The EasyDent / EzDent-i main window will be displayed.
  • Page 52 5. Getting Started 5.2.1 Creating a New Patient Record To create a new patient record, follow the procedure outline below: ❚ EasyDent A. Click the Patient icon on the upper left corner of the EasyDent’s main GUI window. 45 I PaX-i3D Smart...
  • Page 53 B. Enter the required patient information. The Chart Number, E-Mail address, First Name, and Last Name are required fields which must be filled in. (The chart number fills in automatically.) C. Click Add to save the patient record. 46 I PaX-i3D Smart...
  • Page 54 − Search by Name: Search by the name of the patient is possible. − Search by age and gender can be used to divide the search result further, for patients with the same name. ● The user’s Login/Logout time and work duration can be traced via log data. 47 I PaX-i3D Smart...
  • Page 55 B. Enter the Chart No., First name, or Last name of the patient by clicking the mouse on the virtual key board and click the Enter (The physical keyboard can be used to do the same job). C. Patient information can be displayed on the Patient information pane and Patient List. 48 I PaX-i3D Smart...
  • Page 56 Enter Double-click the Keyboard icon to display the virtual keyboard. You may search patient information using the virtual keyboard. B. Double-click the patient information to see more details about the patient as shown below. Double-click 49 I PaX-i3D Smart...

  • Page 57: Initiating The Console Software

    ) in the upper left corner of the EasyDent’s main window to open the imaging program. B. The following imaging program window opens. The sole purpose of this window is to control equipment settings and acquire images. 50 I PaX-i3D Smart...
  • Page 58 C. The main screen for the selected mode appears. (See 4.3 Imaging Software Overview). From the main screen, you can configure the imaging parameter settings prior to acquiring an image. Please proceed to the next chapter. Refer to chapters 6 - 8 for information regarding image acquisition. 51 I PaX-i3D Smart...

  • Page 60: Acquiring Pano Images

    Acquiring PANO images 6.1 Setting Exposure Parameters ..........59 6.2 Patient Positioning ....63 6.3 X-ray Exposure ......77 6.4 Finishing Scan .......78 6.5 Confirming Image ....78...
  • Page 61 Bitewing* Bitewing Incisor* Bitewing Right* Bitewing Left* TMJ LAT Open TMJ LAT Close TMJ PA Open SPECIAL EXAMINATION TMJ PA Close Sinus LAT Sinus PA * Bitewing examinations are available only when Orthogonal Arch is selected. 54 I PaX-i3D Smart...
  • Page 62 Image Narrow (Standard): Panoramic image of V-shaped palatal arches (small number of adult females) Normal (Standard): Panoramic image of normal adult palatal arches Wide (Standard): Panoramic image of square-shaped palatal arches (some number of adult males) 55 I PaX-i3D Smart...
  • Page 63 6. Acquiring PANO images Examination Program Image Child (Standard): Panoramic image of child palatal arches, 40% less x-ray dose than in Normal mode. Bitewing: Imaging from targeted areas of palatal arches; less x-ray dose than in Standard mode. 56 I PaX-i3D Smart...
  • Page 64 TMJ LAT Open / Close: The acquired image focused on the lateral TMJ area. TMJ PA Open / Close: The acquired image focused on the posterior-anterior TMJ area. 57 I PaX-i3D Smart...
  • Page 65 6. Acquiring PANO images Examination Program Image Sinus LAT: The acquired image focused on the lateral Maxillary Sinus area. Sinus PA: The acquired image focused on the posterior-anterior Maxillary Sinus area. 58 I PaX-i3D Smart...

  • Page 66: Setting Exposure Parameters

    This is the normal type. Reconstruct an image with optimized focus (autofocus) from the Magic PAN entire panorama to acquire high quality images so any errors caused (Optional) by issues with the patient's position and tooth trajectory will be minimized. 59 I PaX-i3D Smart...
  • Page 67 Panoramic image where the x-ray angle enters vertically in between the teeth so overlapping images are minimized. Orthogonal If Orthogonal Arch is selected, four bitewing examinations(bitewing, bitewing incisor, bitewing right, bitewing left) are activated 5. Select an Examination Program. 60 I PaX-i3D Smart...
  • Page 68 8. The values of tube voltage and current are configured automatically according to the patient's gender and x-ray intensity. Click the arrow button to zoom in. The dose is adjustable by ±1 kVp and ±0.1 mA respectively. 9. Once the configuration has been completed, click the CONFIRM button. 61 I PaX-i3D Smart...

  • Page 69: Patient Positioning

    ● The Rotating unit will move to its initial scanning position. ● Three laser beams will be activated to make patient positioning easier. ● The Scan Time and DAP values will be shown on the Imaging Status Window. 10. Guide the patient to the equipment. 62 I PaX-i3D Smart...
  • Page 70 2. Ask the patient to wear a lead apron to protect them from residual radiation. 3. Use the Vertical Frame Up/Down button or switch option to adjust the equipment to match the height of the patient. 63 I PaX-i3D Smart...
  • Page 71 3. Guide the patient to the inside of the equipment. 4. Use the Vertical Frame Up/Down button or switch option to adjust the height of the equipment so the patient's chin reaches the chin rest. 64 I PaX-i3D Smart...
  • Page 72 Frankfurt plane laser beam Canine laser beam Edentulous Patient Positioning 1. Remove the bite block from the chin rest. 2. Use the Temple Support Open/Close button on the control panel to widen the temple supports. 65 I PaX-i3D Smart...
  • Page 73 ● Cervical Spine: Straighten your body and stand still. 6. Direct the patient to maintain the posture as described below. ● Mouth: Close your mouth. ● Tongue: Touch the roof of your mouth. ● Two eyes: Close your eyes. 66 I PaX-i3D Smart...
  • Page 74 Be sure to align the laser beam properly. 1. Align the vertical beam with the center of the face. (To prevent horizontal expansion of the image) 67 I PaX-i3D Smart...
  • Page 75 Support Open/Close button on the control panel to prevent the patient's head from moving. 2. Click the READY button. The x-ray exposure has not started yet. 3. Now go to 6.3 X-ray Exposure to begin operation. 68 I PaX-i3D Smart...
  • Page 76 Clean the chin rest with ethanol and wipe with a dry towel before the next patient. 2. Use Temple Support Open/Close button on the control panel to widen temple supports. 3. Guide the patient to the inside of the equipment. 69 I PaX-i3D Smart...
  • Page 77 ● Two eyes: Close your eyes. ● As shown in the picture, the support unit of the integrated chin rest should touch the patient's acanthion point. ● Ask the patient to maintain their position until the operation is completed. 70 I PaX-i3D Smart...
  • Page 78 3. Align the Canine Teeth Beam with the center of the patient's canines. Use the Canine Teeth Beam level to adjust the position of the beam. Mid-sagittal plane laser beam Frankfurt plane laser beam Canine Teeth Beam Canine laser beam lever 71 I PaX-i3D Smart...
  • Page 79 3. Guide the patient to press the base of their nose (acanthion point) against the chin rest and tilt their head forward about -5˚. At this point, make sure the patient's jaw does not to touch the equipment. 72 I PaX-i3D Smart...
  • Page 80 ● Ask the patient to maintain their position until the operation is completed. Laser Beam Positioning This is the same as for TMJ Open mode. Finishing Patient Positioning This is the same as for TMJ Open mode. 73 I PaX-i3D Smart...
  • Page 81 ● Two feet: Keep both feet close to the inside of the base. ● Shoulders: Keep your shoulders relaxed and balanced. ● Cervical Spine: Straighten your body and stand still. 6. After adjusting the integrated chin rest, turn the knob to fix the chin rest. 74 I PaX-i3D Smart...
  • Page 82 ● Head: Tilt the head back 10˚ - 15˚. ● Mouth: Close your mouth. ● Tongue: Touch the roof of your mouth. ● Two eyes: Close your eyes. Ask the patient to maintain their position until the operation is completed. 75 I PaX-i3D Smart...

  • Page 83: X-Ray Exposure

    Support Open/Close button on the control panel to prevent the patient's head from moving. 2. Click the READY button. The x-ray exposure has not started yet. 3. Now go to 6.3 X-ray Exposure to begin operation. 76 I PaX-i3D Smart...
  • Page 84 3. Begin acquisition by pressing the exposure switch. Continue to press the exposure switch until the image has been acquired. Orange: X-ray On 4. Release the exposure switch when “Image capturing is completed” message appears on the screen. 77 I PaX-i3D Smart...

  • Page 85: Finishing Scan

    2. The images are automatically saved if automatic save is configured in the basic settings. If automatic save is not configured in the basic settings, click the Save to DB button to save the images. 3. Double-click the image to confirm in the Patient list. 78 I PaX-i3D Smart...

  • Page 86: Acquiring Ceph Images

    Acquiring CEPH images 7.1 Setting Exposure Parameters ..........82 7.2 Patient Positioning ....85 7.3 X-ray Exposure ......95 7.4 Finishing Scan .......96 7.5 Confirming Image ....96...
  • Page 87 <Scan CEPH> ● Measure 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. <OneShot CEPH> 80 I PaX-i3D Smart...
  • Page 88 Waters frontozygomatic suture, nasal cavity, View coronoid process between the upper jaw and zygomatic arch. <OneShot CEPH> Use to assess hand bone age and CARPUS compare with changes in the skull. <OneShot CEPH> 81 I PaX-i3D Smart...
  • Page 89 2. Select the examination program under Ceph Examination 3. (For One-shot CEPH only) Do the selections that follow. — FOV Size: Select the FOV size. Details Model Large Full size OP(1210SGA) : 12x10 (inches) : 30.48x25.40 (cm) 82 I PaX-i3D Smart...
  • Page 90 Soft ≤ Normal ≤ Hard Average head Classification of head Range (cm) Group circumference circumference > 53±3 Hard Child 53±3 cm 53±3 Normal 53±3 < Soft > 56±3 Hard Adult 56±3 cm 56±3 Normal 56±3 < Soft 83 I PaX-i3D Smart...
  • Page 91 ● The READY button will begin blinking to show that it has been activated. ● The Scan Time and DAP values will be shown on the Imaging Status Window. 8. Guide the patient to the equipment. 84 I PaX-i3D Smart...
  • Page 92 Correct positioning is an important factor in capturing the best possible image. Although the illustrations and explanations on patient’s posture and device usage are based on the OS / OP models (one shot-type sensor), those for the SC (scan type) model should be the same. 85 I PaX-i3D Smart...
  • Page 93 Porion. Porion position reference indicator 2. Guide the patient to the CEPH unit. 3. Direct the patient to relax their neck and shoulders and stand upright. 86 I PaX-i3D Smart...
  • Page 94 7. Direct the patient to swallow first before closing their mouth and to remain in their current position until image acquisition is complete. 8. Click the READY button. The x-ray exposure has not started yet. 9. Now go to 7.3 X-ray Exposure to begin operation. 87 I PaX-i3D Smart...
  • Page 95 2. Fold the nasal positioner up. The nasal positioner is not used in Frontal mode. 3. Guide the patient to the CEPH unit. 4. Ask the patient to stand upright facing the sensor. Make sure that the patient’s shoulders are level and that his/her neck is relaxed. 88 I PaX-i3D Smart...
  • Page 96 8. Direct the patient to swallow first before closing their mouth and to remain in their current position until image acquisition is complete. 9. Click the READY button. The x-ray exposure has not started yet. 10. Now go to 7.3 X-ray Exposure to begin operation. 89 I PaX-i3D Smart...
  • Page 97 Porion. 2. Fold the nasal positioner up. The nasal positioner is not used in Frontal mode. 3. Guide the patient to the CEPH unit. 4. Guide the patient to face the X-ray tube and stand upright. 90 I PaX-i3D Smart...
  • Page 98 8. Direct the patient to swallow first before closing their mouth and to remain in their current position until image acquisition is complete. Frankfurt plane 9. Click the READY button. The x-ray exposure has not started yet. 10. Now go to 7.3 X-ray Exposure to begin operation. 91 I PaX-i3D Smart...
  • Page 99 CEPH Unit to approximately match the height of the patient. 6. During operation, properly align the ear rods with the patient's ears so their head does not move. After adjusting the height of the column, align the ear rods and nasal positioner with the patient. 92 I PaX-i3D Smart...
  • Page 100 CARPUS Mode ❚ Installing the Carpus Plate 1. Align the end of the nasal positioner to the carpus plate groove so it is attached to the nasal positioner. Locking bolt Nasal positioner Fixed bolt Notch CARPUS Plate 93 I PaX-i3D Smart...
  • Page 101 2. Ask the patient to close their eyes and stand still until the image acquisition is completed. Make sure the patient's fingers do not to block the positioner. Doing so may reduce the image quality. 94 I PaX-i3D Smart...
  • Page 102 3. Begin acquisition by pressing the exposure switch. Continue to press the exposure switch until the image has been acquired. Orange: X-ray On 4. Release the exposure switch when “Image capturing is completed” message appears on the screen. 95 I PaX-i3D Smart...
  • Page 103 2. The images are automatically saved if automatic save is configured in the basic settings. If automatic save is not configured in the basic settings, click the Save to DB button to save the images. 3. Double-click the image to confirm in the Patient list. 96 I PaX-i3D Smart...

  • Page 104: Acquiring Ct Images

    Acquiring CT Images 8.1 Setting Exposure Parameters ..........98 8.2 Patient Positioning ....101 8.3 X-ray Exposure ....106 8.4 Finishing Scan .....108 8.5 Confirming Image ....108...
  • Page 105 Please refer to 4.3 Console Software for more information. ❚ Steps for Configuring Imaging Conditions 1. Click CBCT. 2. Select FOV Size. (Select 100 x 85 or 100 x 70) 100 x 85: for Adult, 100 x 70: for Child 98 I PaX-i3D Smart...
  • Page 106 MAR(Metal Artifact Reduction) is applied automatically if there are metal objects in the image. MAR may increase image reconstruction time. 5. The gender of the patient is selected automatically. When necessary, it can be selected directly. 99 I PaX-i3D Smart...
  • Page 107 ● The READY button will begin blinking to show that it has been activated. ● The Rotating unit will move to its initial scanning position. ● The laser beam will be activated to make patient positioning easier. 100 I PaX-i3D Smart...
  • Page 108 In general, images are acquired when the patient is standing. In special cases, a chair without a backrest (stool) may be used. Do not obstruct the laser beam or the operation of the equipment with the chair. 101 I PaX-i3D Smart...
  • Page 109 The sanitary vinyl cover is for single use only. It should be replaced after each patient. Be sure to use the approved vinyl cover. Clean the chin rest and bite block with ethanol and wipe with a dry towel before the next patient. 102 I PaX-i3D Smart...
  • Page 110 7. Turn the knob to fix the bite block in place. 8. Direct the patient to maintain the posture as described below. ● Mouth: Close your mouth. ● Tongue: Touch the roof of your mouth. ● Two eyes: Close your eyes. 103 I PaX-i3D Smart...
  • Page 111 ● Mouth: Bite the bite block and close your mouth. ● Tongue: Touch the roof of your mouth. ● Two eyes: Close your eyes. Ask the patient to maintain their position and to not move until the image acquisition is completed. 104 I PaX-i3D Smart...
  • Page 112 FOV 100 X 85 This is a sample illustration for reference only. Actual FOV may vary from the image shown. Align the Mid-sagittal plane laser beam with the center of the face. (To prevent horizontal expansion of the image) 105 I PaX-i3D Smart...
  • Page 113 Also direct the patient to not move. 1. Direct the patient to close their eyes. 2. The user closes the door when leaving the X-ray room. Observe the patient during operation and check the imaging status. 106 I PaX-i3D Smart...
  • Page 114 ● The exposure switch LED light on top of the equipment is orange. ● An alert will sound to indicate that x-ray emission is currently underway. ● In the console software, the x-ray On in yellow changes. 107 I PaX-i3D Smart...
  • Page 115 2. The images are automatically saved if automatic save is configured in the basic settings. If automatic save is not configured in the basic settings, click the Save to DB button to save the images. 3. Double-click the image to confirm in the Patient list. 108 I PaX-i3D Smart...

  • Page 116: Troubleshooting

    Troubleshooting...
  • Page 117 Check whether it is ready for capturing at the console Ready status software. If imaging cannot be performed Cause Solution Wait until the equipment has initialized and then try Initialization status again. If this problem persists, restart the equipment. 110 I PaX-i3D Smart...
  • Page 118 You may then safely release the patient from the equipment. Do not allow any liquids in the vicinity of the machine as moisture may cause extensive damage to this equipment’s electrical components. 111 I PaX-i3D Smart...

  • Page 120: Cleaning And Maintenance

    Cleaning and Maintenance 10.1 Cleaning ........114 10.2 Maintenance .........115...

  • Page 121: Maintenance

    Wipe the unit with a dry cloth at the end of Outer covers of equipment each day. Do not use cleaning agents in aerosol or spray form directly on the surface of the equipment. 114 I PaX-i3D Smart...
  • Page 122 Cleaning and Maintenance 10.2 Maintenance VATECH requires periodic constancy tests to ensure image quality and the safety for the patient and operator. Only VATECH authorized technicians can perform inspection and service of this equipment. For the technical assistance, contact VATECH service center or your local VATECH representative.
  • Page 123 Check for possible wear or damage to the exposure switch cable. Monthly Confirm that the audio message is audible throughout the duration of Monthly the exposure. Please refer to the “Constancy Test Requirement” for documents about the image quality inspection methods. 116 I PaX-i3D Smart...

  • Page 124: Disposing Of The Unit

    Disposing of the Unit...
  • Page 125 ● Paper ● X-ray tube Sensor head Return the sensor head to VATECH ● Other parts This dental equipment shall not be disposed of as domestic garbage materials. Please clean the equipment before dissembling it and disposing of its parts.

  • Page 126: Technical Specifications

    Technical Specifications 12.1 Mechanical Specifications ...120 12.2 Technical Specifications ....125 12.3 Electrical Specifications ....129 12.4 Environmental Specifications ..129...
  • Page 127 CEPH 1745 1524 1.14 CONSTANT ■ FDD: Focal Spot to Detector Distance ■ FOD: Focal Spot to Object Distance ■ ODD: Object to Detector Distance (ODD = FDD - FOD) ■ Magnification = FDD / FOD 120 I PaX-i3D Smart...
  • Page 128 ■ Without cephalometric unit & Non-Base type TOP VIEW FRONT VIEW 444.1(17.5) 205(8.1) 85 (3.3) 1113 (43.8) [mm(inch)] ■ Without cephalometric unit & Base type FRONT VIEW TOP VIEW 75 (3) 942 (37.1) 470 (18.5) 85 (3.3) 1113 (43.8) [mm(inch)] 121 I PaX-i3D Smart...
  • Page 129 ■ With cephalometric unit & Non-Base type FRONT VIEW TOP VIEW 444.1(17.5) 205(8.1) 1113 (43.8) 1882.3 (74.1) [mm(inch)] ■ With cephalometric unit & Base type FRONT VIEW TOP VIEW 75 (3) 942 (37.1) 470 (18.5) 85 (3.3) 1113 (43.8) 1882.3 (74.1) [mm(inch)] 122 I PaX-i3D Smart...
  • Page 130 12. Technical Specifications ■ Common Dimensions(Non-Base type) SIDE VIEW FRONT VIEW 406(16) 114.6(4.51) 203(8) [mm(inch)] ■ Common Dimensions(Base type) SIDE VIEW FRONT VIEW 406(16) 107.04(4.21) 203(8) [mm(inch)] 123 I PaX-i3D Smart...
  • Page 131 74.1(L) x 55.1(W) x 92(H) inch x Height) 1882 (L) x 1400 (W) x 2336 (H) mm with CEPH unit (oneshot type) 74.1(L) x 55.1(W) x 92(H) inch Type of installation Base stand / Wall mount 124 I PaX-i3D Smart...
  • Page 132 5 ° X- ray Coverage 95 x 380 mm at SID 550 mm Anode Heat Content 35 kJ 1:60 or more (Exposure time : Duty Cycle Interval time) INV-11 Inverter 1.35 kg Weight DG-07CT2(H-Type) 12.5 kg Monotank 125 I PaX-i3D Smart...
  • Page 133 12. Technical Specifications ❚ D-052SB ❚ Maximum Rating Charts DC (Center Grounded) 126 I PaX-i3D Smart...
  • Page 134 12. Technical Specifications ❚ Emission & Filament Characteristics ❚ Anode Thermal Characteristics 127 I PaX-i3D Smart...
  • Page 135 Pixel size (㎛) Active area (mm) 5.9 x 230.4 264 x 352 222 x 254 Frame rate (FPS) A/D (bits) Sensor size (mm) 251.2 x 69 x 27.1 402 x 364 x 32 314 x 279 x 24 128 I PaX-i3D Smart...

  • Page 136: Electrical Specifications

    10 ~ 35 ℃ During operating Relative humidity 30 ~ 75 % Atmospheric pressure 860 ~ 1060 hPa Temperature -10 ~ 60 ℃ Transport and Relative humidity 10 ~ 75 % storage Atmospheric pressure 860 ~ 1060 hPa 129 I PaX-i3D Smart...

  • Page 138: Appendices

    Appendices 13.1 Recommended X-ray Exposure Table ..........132 13.2 X-ray Dose Data ......135 13.3 Electromagnetic Compatibility ..(EMC) Information ......139 13.4 Acquiring image for the pediatric ..dental patient ........142 13.5 Abbreviations .......145...
  • Page 139 81/10 Child 82/10 80/10 78/10 PA / SMV / Waters View Figure Hard (kVp / mA) Normal (kVp / mA) Soft (kVp / mA) Gender 90/10 88/10 86/10 Woman 88/10 86/10 84/10 Child 85/10 83/10 80/10 132 I PaX-i3D Smart...
  • Page 140 * Tube voltage and current variation range in the CEPHALOMETRIC mode (recommended) : 60 ~ 90 kVp, 4 ~ 12 mA ❚ C. CBCT Low Dose Ultra Low Dose Mode Hard Normal Soft Hard Woman Normal Soft Hard Child Normal Soft 133 I PaX-i3D Smart...
  • Page 141 ● Maximally allowed tube voltage / current: kVp ± 10 % / mA ± 20 % according to IEC60601-2-7. ● Due to image optimization performed prior to shipping, equipment data may differ slightly from those specified in the table. 134 I PaX-i3D Smart...

  • Page 142: X-Ray Dose Data

    The X-ray dose data is extracted from the X-ray Dose Test Report for the PaX-i3D Smart. X-ray Dose Test Report for the PaX-i3D Smart maintains dosemetric evaluation of VATECH dental diagnostic system meets all requirements specified in the IEC Collateral Standard.
  • Page 143 Mode Tested: CT (FOV 100x85), 18s [mGyㆍ [mGyㆍ [mGyㆍ [mGy] [mGy] [mGy] cm2] cm2] cm2] 3.16 157.75 4.18 209.20 5.12 255.95 4.58 229.05 6.12 305.80 7.65 382.55 6.33 316.55 8.38 418.95 10.47 523.65 8.16 409.45 10.88 543.90 13.54 676.95 136 I PaX-i3D Smart...
  • Page 144 Applied Tube Current [mA] PANO Normal Adult 13.6s [mR/hr] Mode 1 m (3.3 ft) 1.5 m (4.9 ft) 2 m (6.6 ft) Direction [°] 60.9 17.7 19.6 12.4 10.6 22.1 12.5 45.4 21.4 47.6 21.9 76.4 19.4 137 I PaX-i3D Smart...
  • Page 145 1 m (3.3 ft) 1.5 m (4.9 ft) 2 m (6.6 ft) Direction [°] 588.2 135.3 87.1 549.3 249.4 106.8 472.6 307.3 78.4 458.8 287.6 89.3 12.9 410.5 288.7 98.2 663.2 301.4 112.4 429.7 194.2 92.3 138 I PaX-i3D Smart...

  • Page 146: Electromagnetic Compatibility (Emc) Information

    Guidance and manufacturer’s declaration - electromagnetic emissions. The model PaX-i3D Smart(PHT-30LFO) is intended for use in the electromagnetic environment specified below. The customer or the user of the model PaX-i3D Smart(PHT-30LFO) should assure that it is used in such an environment.
  • Page 147 Guidance and manufacturer’s declaration - electromagnetic immunity The model PaX-i3D Smart(PHT-30LFO) is intended for use in the electromagnetic environment specified below. The customer or the user of the model PaX-i3D Smart(PHT-30LFO) should assure that it is used in such an environment.
  • Page 148 Guidance and manufacturer’s declaration - electromagnetic immunity The model PaX-i3D Smart(PHT-30LFO) is intended for use in the electromagnetic environment specified below. The customer or the user of the model PaX-i3D Smart(PHT-30LFO) should assure that it is used in such an electromagnetic environment...

  • Page 149: Acquiring Image For The Pediatric Dental Patient

    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 in toward the vertical column of the X-Ray device into a position that feels as if he/she is slightly leaning backward. 142 I PaX-i3D Smart...
  • Page 150 To characterize the out-of-field doses in pediatric radiotherapy and to identify simple methods by which out-of-field dose might be minimized, with a view to reducing the risk of secondary cancers Out-of-field doses to pediatric patients can be minimized by using simple treatment 143 I PaX-i3D Smart...
  • Page 151 CT and 17.2 mGy for thyroid in neck CT. 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. 144 I PaX-i3D Smart...

  • Page 152: Abbreviations

    Field of View Flat Panel Detector International Electro technical Commission International Standards Organization Liquid Crystal Display Light-Emitting Diode Metal Artifact Reduction MPSO Multiple Portable Socket-Outlet Object to Detector Distance Posterior / Anterior Radio Frequency Region of Interest 145 I PaX-i3D Smart...
  • Page 153 13. Appendices Source to Image receptor Distance Signal Input Part Signal Output Part Submento-Vertical Temporomandibular Joint Ultra High Definition 146 I PaX-i3D Smart...
  • Page 154 13. Appendices 147 I PaX-i3D Smart...
  • Page 156 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 which may be required due to technical improvement. For the most current information, contact your VATECH representative. Tel: +82-1588-9510 Email: gcs@vatech.co.kr...

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