Vatech PAX-I User Manual
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User Manual
Model : PCH-2500
Version : 2.72
• English
Full version

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Summary of Contents for Vatech PAX-I

  • Page 1 User Manual Model : PCH-2500 Version : 2.72 • English Full version...
  • 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: Table Of Contents

    System Components.............22 3.1.2 Features ................22 3.1.3 The PaX-i Options..............23 3.1.4 Standards and Regulations...........23 Imaging System Structure ........... 24 General View of the PaX-i ........... 27 3.3.1 Laser Beams .................29 3.3.2 The Exposure Switch ............29 3.3.3 Emergency Stop Button ............30 3.3.4 Components and Positioning Accessories ......31...
  • Page 5 Imaging Software Overview ..........42 4.3.1 PANO Mode ................47 4.3.2 CEPH Mode ................51 Getting Started ..........54 Turning on the PaX-i ............54 Running the Image Viewer – EasyDent ....... 55 5.2.1 Creating a New Patient Record ..........55 5.2.2 Retrieving Patient Records ...........56 Initiating the Imaging Program ..........
  • Page 6 Age group: classification table ........... 130 Positioning the pediatric dental patient ......130 Setting exposure values to the age group ......131 The references pertinent to the potential risks for the pediatric patients ................131 Abbreviations ..........134 PaX-i (PCH-2500) User Manual...
  • Page 7 General Information Notice .................. 08 Manufacturer's Liability ............09 Owner and Operator's Obligations ........09 Conventions in this Manual ..........10...
  • Page 8: General Information

    VATECH Co., Ltd. Phone: +82-1588-9510 E-mail: gcs@vatech.co.kr This document is originally written in English. The PaX-i is referred to as Equipment in this manual. Manual Name: PaX-i (PCH-2500) User Manual Version: 2.72 Publication Date: 2018-05 PaX-i (PCH-2500) User Manual...
  • Page 9: Manufacturer's Liability

    ■ 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.
  • Page 10: Conventions In This Manual

    Indicates a situation or action that could IMPORTANT potentially cause problems to the equipment and/or its operation. IMPORTANT Emphasizes important information or provide NOTE useful tips and hints. NOTE Indicates a component which must be replaced SINGLE USE for each new patient. PaX-i (PCH-2500) User Manual...
  • Page 11 Warnings and Precautions General Safety Precautions ..........12 Electricity-related Safety Precautions ........16 Radiation Safety ..............17 Warnings ................18...
  • Page 12: Warnings And Precautions

    ■ 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-i (PCH-2500) User Manual...
  • Page 13 ■ 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 14 ■ 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-i (PCH-2500) User Manual...
  • Page 15 ■ 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. PaX-i (PCH-2500) User Manual...
  • Page 16: Electricity-Related Safety Precautions

    ■ Do not connect this equipment to a Multiple Portable Socket-Outlet (MPSO) or extension cord. Electromagnetic compatibility ■ The PaX-i X-Ray unit complies with IEC standard 60601-1-2. ■ Medical electrical equipment is subject to special EMC preventive measures. It must be installed and operated as specified in the Installation Requirements document.
  • Page 17: Radiation Safety

    ■ The operator must immediately stop imaging if the equipment malfunctions. As a manufacturer of radiology equipment that conforms to stringent protection standards around the world, we guarantee the maximum degree of protection against WARNING radiation hazards for our equipment. PaX-i (PCH-2500) User Manual...
  • Page 18: Warnings

    Dental X-ray system. WARNING PaX-i 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 19 ■ 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/or cause injury. ■ Unplug the equipment’s power cable before extinguishing any fire. PaX-i (PCH-2500) User Manual...
  • Page 20 Installation ■ In order to avoid improperly balanced equipment, install the device on a flat surface to maintain stability. ■ If the equipment is not stable, property damage and/or personal injury may occur. ■ Do not push or pull the equipment. ■...
  • Page 21 System Components.............22 3.1.2 Features ................22 3.1.3 The PaX-i Options..............23 3.1.4 Standards and Regulations...........23 Imaging System Structure ........... 24 General View of the PaX-i ........... 27 3.3.1 Laser Beams .................29 3.3.2 The Exposure Switch ............29 3.3.3 Emergency Stop Button ............30 3.3.4 Components and Positioning Accessories ......31...
  • Page 22: Pax-I Imaging System Overview

    The PaX-i may only be used by dentists, X-Ray technicians and other professionals who are licensed to perform X-rays by the law of the region in which it is being used. (The PaX-i may be used for ENT (Ear, Nose and Throat) examination in countries requiring the CE marking.) 3.1.1...
  • Page 23: The Pax-I Options

    2 in 1 3.1.4 Standards and Regulations Standards: The PaX-i is designed and manufactured to meet the following standards: IEC/EN/UL 60601-1, IEC/EN 60601-1-1, IEC/EN 60601-1-2, IEC/EN 60601-1-3, IEC/EN 60601-2-7, IEC/EN 60601-2-28, IEC/EN 60601-2-32, ISO 9001, ISO 13485 NEMA Standard publication PS 3.1-3.18, 2008...
  • Page 24: Imaging System Structure

    3. PaX-i Imaging System Overview The CE symbol grants this equipment compliance with the European Directive for Medical Devices 93/42/EEC as amended by 2007/47/EC as a 2460 class IIb device. This equipment received the CSA certification mark in accordance with CAN/CSA C22.2 No.601.1 regulations.
  • Page 25 3. PaX-i Imaging System Overview 1. Signal input/output at PC A. Keyboard input B. Mouse input C. RS-232 port D. Video out E. Frame grabber cable (LVDS) Case B: LAN Cable UP/DOWN switch PaX-i (Optional) Exposure switch CAT6 Cross Ethernet Cable(10 m/32.8’) Ethernet cable(OS: 10 m/32.8’)
  • Page 26 In addition, all such combination systems must comply NOTE with IEC60601-1 and/or IEC60601-1-1 harmonized national standards or relevant combination standards. If in doubt, contact a qualified technician or your local VATECH representative. PaX-i (PCH-2500) User Manual...
  • Page 27: General View Of The Pax-I

    3. PaX-i Imaging System Overview 3.3 General View of the PaX-i SCAN TYPE ( OPTIONAL) LED LAMP ROTATING UNIT X-RAY SENSOR (PANO) X-RAY SENSOR(CEPH) EAR RODS X-RAY TUBE NARSAL POSITIONER TEMPLE SUPPORT CHIN SUPPORT SECONDARY COLLIMATOR COLUMN UP/DOWN BUTTON LASER BEAM ON/OFF BUTTON...
  • Page 28 3. PaX-i Imaging System Overview Item Details - Positions the patient during CEPH imaging. NASAL POSITIONER - The ruler for use to compensate the acquired image that is different from actual size. Limits the X-Ray irradiation field for CEPH SECONDARY COLLIMATOR scanning.
  • Page 29: Laser Beams

    3. PaX-i Imaging System Overview The structural overview of the PaX-i may differ depending on the model. For more information, refer to section 3.1.3: NOTE The PaX-i Options. 3.3.1 Laser Beams 1-Frankfurt laser beam / 2-Mid-sagittal plane laser beam / 3-Canine laser beam 3.3.2...
  • Page 30: Emergency Stop Button

    3. PaX-i Imaging System Overview 3.3.3 Emergency Stop Button During operation, the following emergency situations may occur: ■ X-Ray emission continues after the exposure switch has been released ■ Injury to the patient or damage to the equipment ■ Other emergency situations...
  • Page 31: Components And Positioning Accessories

    3. PaX-i Imaging System Overview 3.3.4 Components and Positioning Accessories The following accessories can be disinfected after they have been separated from the equipment. Disinfect all accessories which come into direct contact with the patient, such as the bite block, chin support or temple supports, using an alcohol-based solution and allow them to dry before use.
  • Page 32: Examination Programs And Exposure Time

    3. PaX-i Imaging System Overview 3.4 Examination Programs and Exposure Time The PaX-i has been designed to carry out the following radiological examinations: ■ PANO ■ CEPH (optional) 3.4.1 PANO Mode PANO TYPE: NORMAL One of three versions of the panoramic imaging program will be included with your system, depending on the purchase option chosen.
  • Page 33 3. PaX-i Imaging System Overview Exposure Time (Max. 20.2 s) Scan Time (s) Arch Examination Examination Selection Mode Normal Standard 20.2 13.5 10.1 Right 10.1 Narrow Front 16.7 11.1 Left 10.1 Standard 20.2 13.5 10.1 Right 10.1 Normal Front 16.7 11.1...
  • Page 34: Ceph Mode

    3. PaX-i Imaging System Overview Indicates that the examination supports Magic PAN / AF mode. NOTE - Maximum exposure time deviation: ± 10 % (IEC 60601-2-7) - Standard mode exposure time is the same for both AF NOTE and non-AF modes.
  • Page 35 3. PaX-i Imaging System Overview Symbols Description Location Protective earth (Ground) Power board Off (power: disconnect from the main Main switch switch) On (power: connect to the main switch) Main switch TYPE B Equipment Label Radiation hazard Label EC representative...
  • Page 36 3. PaX-i Imaging System Overview Symbols Description Location Caution: Federal law restricts this device to sale by or on the order of a Label licensed healthcare practitioner. Indicates that the user needs to refer to Label the Instruction Manual. Indicates the date of manufacture.
  • Page 37: Label Locations

    3. PaX-i Imaging System Overview 3.5.1 Label Locations The label is attached to the right side of the equipment and it consists of 5 parts as below.      Item Main Label CAUTION Label - X-ray / Attention: X-ray on when equipment in operation.
  • Page 38 This page is left intentionally blank.
  • Page 39 Software Overview PC System Requirements (Recommended) ....... 40 EasyDent ................41 Imaging Software Overview ..........42 4.3.1 PANO Mode ................47 4.3.2 CEPH Mode ................51...
  • Page 40: Software Overview

    Intel Ethernet I210-T1 PCIe x1 Gb NIC (Option) Serial Port RS232) 1 (On-board) Power supply ≥ 400 Watts (92% Efficiency) 2 PCI Express x 1 Slot Slots 1 PCI Express x 16 1 PCI Express x 16(x 4) PaX-i (PCH-2500) User Manual...
  • Page 41: Easydent

    HP EliteDesk 800 G2 Tower 4.2 EasyDent As the basic imaging platform for all VATECH dental X-Ray equipment, EasyDent is designed to be easy to use. The Imaging Program is interfaced with EasyDent. Images acquired by the Imaging Program are imported directly into EasyDent, where analysis and diagnosis can be performed quickly and easily.
  • Page 42: Imaging Software Overview

    A. Imaging Mode Display This displays the current imaging mode. - Indicates that the Magic PAN is supported in the PANO imaging modality. NOTE - Is displayed only in the ‘Standard’ mode, with the Magic PAN-enabled. PaX-i (PCH-2500) User Manual...
  • Page 43 Adjustable resolution: - Tube voltage: ± 1 kVp NOTE - Tube current: ± 1 mA For the tube voltage and its correspondence with the current patient, refer to Appendix 1: Recommended X-Ray NOTE Exposure Table. PaX-i (PCH-2500) User Manual...
  • Page 44 Child 53±3 cm 53±3 Normal 53±3 < Soft > 56±3 Hard Adult 56±3 cm 56±3 Normal 56±3 < Soft I. Phantom capture This function is used when the Phantom Jig is being used to acquire images. PaX-i (PCH-2500) User Manual...
  • Page 45 Use this icon to turn the laser beam on or off for patient positioning. This button is enabled when the Confirm button is clicked after the imaging environmental parameters are configured. K. Settings This Control Panel displays and sets various equipment-related parameters, including language, automatic save, DAP display unit, etc. PaX-i (PCH-2500) User Manual...
  • Page 46 DAP (Dose Area Product) value will be shown on the main display for the exposure you are going to take. O. Ready This button is used when all aspects of preparation have done for image acquisition (including parameter settings and patient positioning). PaX-i (PCH-2500) User Manual...
  • Page 47: Pano Mode

    1. Ask the engineer in your region for the mode change. NOTE 2. Re-run the imaging program after setting up the related parameters. The default mode, if any, specified in a specific country can't be changed for the user's intent. PaX-i (PCH-2500) User Manual...
  • Page 48 Imaging lateral right Supported by any arch type selection Front Imaging frontal area Left Imaging lateral left The following table summarizes the sub-modes for orthogonal imaging. *Orthogonal mode: Acquires an image that minimizes overlapping regions of teeth. PaX-i (PCH-2500) User Manual...
  • Page 49 Imaging PANO lateral Right right Imaging PANO frontal Front area Imaging PANO lateral Left left Supported by any arch type selection Bitewing Left/Right Bitewing Incisor Incisor region Bitewing imaging Bitewing Right Right region Bitewing Left region Left PaX-i (PCH-2500) User Manual...
  • Page 50 TMJ with the mouth open. Takes a posterior/anterior image of TMJ PA Close the TMJ with the mouth closed. Takes a side view image of the Sinus LAT sinus. Takes a posterior-anterior image of Sinus PA the sinus. PaX-i (PCH-2500) User Manual...
  • Page 51: Ceph Mode

    Select the imaging mode – Lateral, PA, SMV, Waters View or Carpus. Mode Details Lateral / Takes a lateral view image either Full Lateral partially or fully Takes a posterior-anterior image Takes a SMV(Sub-Mento Vertical) image PaX-i (PCH-2500) User Manual...
  • Page 52 0.7 s to 1.2 s (One-shot type only). NOTE Scan Type Sensor (optional) Examination Modes Scan Time (s) - Default Lateral / PA / SMV / Waters View / Carpus 12.9 Full Lateral (optional) 16.9 PaX-i (PCH-2500) User Manual...
  • Page 53 Getting Started Turning on the PaX-i ............54 Running the Image Viewer – EasyDent ....... 55 5.2.1 Creating a New Patient Record ..........55 5.2.2 Retrieving Patient Records ...........56 Initiating the Imaging Program ..........57...
  • Page 54: Getting Started

    5. Getting Started Getting Started 5.1 Turning on the PaX-i A. Before turning the equipment on, check whether the system is correctly connected and installed (check the connection status between the equipment and the PC). B. Turn the ON / OFF switch underneath the handle frame to the ON position.
  • Page 55: Running The Image Viewer - Easydent

    5.2 Running the Image Viewer – EasyDent EasyDent is a basic imaging platform for all VATECH’s dental X-Ray equipment. The Imaging Program is interfaced with EasyDent. O n y o u r d e s k t o p , d o u b l e - c l i c k E a s y D e n t i c o n o r c l i c k S t a r t → A l l Programs→EasyDent.
  • Page 56: Retrieving Patient Records

    D. Click Add to save the patient record. 5.2.2 Retrieving Patient Records You can search through the patient database using a patient’s chart number, their first name, or their last name. PaX-i (PCH-2500) User Manual...
  • Page 57: Initiating The Imaging Program

    5.3 Initiating the Imaging Program A. First, click the patient information in the patient list, and click the PANO/ CEPH icon in the upper left corner of the EasyDent’s main window to open the imaging program. PaX-i (PCH-2500) User Manual...
  • Page 58 B. The following imaging program window opens. The sole purpose of this window is to control equipment settings and acquire images. Please proceed to the next chapter. Refer to chapters 6-7 for information regarding image acquisition. NOTE PaX-i (PCH-2500) User Manual...
  • Page 59 Acquiring PANO Images PANO Imaging Program ............60 Setting Exposure Parameters ..........65 Positioning the Patient ............68 6.3.1 Pano Standard Mode (QR Code)..........69 6.3.2 TMJ Open Mode ..............73 6.3.3 TMJ Close Mode ..............76 6.3.4 Sinus Mode ................77 Initiating X-Ray Exposure ............ 80...
  • Page 60: Acquiring Pano Images

    ⑤ Standard Right Front Left ⑥ Orthogonal Bitewing Bitewing Incisor Bitewing Right Bitewing Left ⑦ TMJ LAT Open TMJ LAT Close ⑧ TMJ PA Open SPECIAL EXAMINATION TMJ PA Close ⑨ Sinus LAT ⑩ Sinus PA PaX-i (PCH-2500) User Manual...
  • Page 61 (typically for some females) ② Normal_Standard A panoramic imaging mode for the adult patients with the normal arch trajectories ③ Wide_Standard A panoramic imaging mode for the patients with the square- shaped arch trajectory (typically for some males) PaX-i (PCH-2500) User Manual...
  • Page 62 X-Ray exposure is 40% less than that in Normal mode ⑤ Orthogonal_Standard A panoramic imaging mode to minimize the overlapped region of the teeth from the X-Ray exposure which is beamed perpendicularly between teeth PaX-i (PCH-2500) User Manual...
  • Page 63 ⑧ TMJ PA 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 close (Open and Close). PaX-i (PCH-2500) User Manual...
  • Page 64 X-Ray beam is directed on the lateral region of the maxillary sinus ⑩ Sinus PA A special imaging mode to acquire a Sinus image, in which X-Ray beam is directed on the frontal region of the maxillary sinus PaX-i (PCH-2500) User Manual...
  • Page 65: Setting Exposure Parameters

    Image with ultra-high resolution optional C. Select the image quality of the image. Mode Details Image with an Ultra-high resolution optional Image with higher resolution than Normal Takes longer scan time than the Normal Normal Normal image PaX-i (PCH-2500) User Manual...
  • Page 66 EasyDent. Nevertheless, ensure that this information is correct. Age Group VATECH’s Standard Child ≤ 12 Adult ≥ 13 Woman G. Select X-ray intensity. X-ray intensity (Hard, Normal, Soft) is according to the operator's decision. NOTE Soft ≤ Normal ≤ Hard. PaX-i (PCH-2500) User Manual...
  • Page 67 Area Product) values will be shown on the main display for the selected exposure. J. Guide the patient to the equipment. Position the patient within the equipment. For further information about patient positioning, refer to section 6.3: Positioning the Patient. PaX-i (PCH-2500) User Manual...
  • Page 68: Positioning The Patient

    CAUTION zoomed in or out or a ghost may appear in the image. Be careful not to project the laser beams directly into the patient’s eyes as this could severely damage the patient’s WARNING vision. PaX-i (PCH-2500) User Manual...
  • Page 69: Pano Standard Mode

    D. Guide the patient —facing the chin support — to the equipment. E. Adjust the height of the column using the column up/down button or switch (optional) until the patient’s chin rests comfortably on the chin support. Column up/down button PaX-i (PCH-2500) User Manual...
  • Page 70 ■ Close his/her eyes Ask the patient to remain still until scanning is completed. To acquire the best image possible, ask the patient not to: - Breathe or swallow saliva during image acquisition CAUTION - Move during image acquisition PaX-i (PCH-2500) User Manual...
  • Page 71 Frankfurt plane laser beam Canine laser beam Frankfurt plane laser beam lever C. Canine laser beam: Have the patient smile to properly position the canine laser beam on the center of the patient’s canine tooth. PaX-i (PCH-2500) User Manual...
  • Page 72 B. Click the Ready button on the GUI or Touchscreen after the patient has been properly positioned. No X-Ray will be emitted at this point. The rotating unit will then move into position for imaging. C. Proceed to section 6.4: Initiating X-Ray Exposure. PaX-i (PCH-2500) User Manual...
  • Page 73: Tmj Open Mode

    D. Adjust the height of the equipment using the column up/down button or switch (optional) until the patient’s chin is resting on the chin support. Ensure that the chin is in contact with the chin support. PaX-i (PCH-2500) User Manual...
  • Page 74 The beams will disappear after 20 minutes or if the ‘Ready’ button is clicked. NOTE To turn the laser beams on or off, click the icon on the handle frame or the icon on the imaging GUI. PaX-i (PCH-2500) User Manual...
  • Page 75 A. After confirming patient positioning and beam alignment, adjust the temple supports to fit snugly on both sides of the patient’s head using the temple support wheel. The temple support wheel is located underneath the patient support rest. PaX-i (PCH-2500) User Manual...
  • Page 76: Tmj Close Mode

    Ask the patient to remain still until scanning is complete. C. The laser beams should be aligned in the same way as for TMJ Open imaging. D. Proceed to section 6.4: Initiating X-Ray Exposure. PaX-i (PCH-2500) User Manual...
  • Page 77: Sinus Mode

    (optional) until the patient’s chin rests comfortably on the chin support. Column up/down button E. Ask the patient to: ■ Stand upright ■ Firmly grip the handle ■ Lean his/her chest lightly against the equipment ■ Position his/her feet slightly forward. PaX-i (PCH-2500) User Manual...
  • Page 78 The beams will disappear after 20 minutes or if the ‘Ready’ button is clicked. NOTE To turn the laser beams on or off, click the icon on the handle frame or the icon on the imaging GUI. PaX-i (PCH-2500) User Manual...
  • Page 79 B. Click the Ready button on the PC or Touchscreen after the patient has been properly positioned. At this point, X-Ray will not be emitted. The rotating unit will move to position for imaging. C. Proceed to section 6.4: Initiating X-Ray Exposure. PaX-i (PCH-2500) User Manual...
  • Page 80: Initiating X-Ray Exposure

    - The operator shall observe the X-Ray safety regulations WARNING applicable to their area at all times during the operation of this equipment. If an emergency occurs during image acquisition, release the exposure switch to cease X-Ray emission. CAUTION PaX-i (PCH-2500) User Manual...
  • Page 81 GUI turns yellow to indicate X- X-Ray ON indicator Rays are being emitted. C. The image appears in real time on the imaging GUI. CASE 1: Normal / AF Normal / AF: 5 images view is set PaX-i (PCH-2500) User Manual...
  • Page 82 NOTE CASE 2: Magic PAN Two images are obtained, with each in the Magic PAN and Normal respectively. You would click either button to compare them with each other. PaX-i (PCH-2500) User Manual...
  • Page 83 The patient’s most recent image will appear on the far left of the image window, as shown below. F. Double-click an image to enlarge it for viewing or to check the quality of the image, as shown below. PaX-i (PCH-2500) User Manual...
  • Page 84 6. Acquiring PANO Images After Image Acquisition After acquiring the image, complete the following steps: ■ Loosen the temple supports to release the patient. ■ Remove the hygiene cover from the bite block (for Standard PANO mode only). PaX-i (PCH-2500) User Manual...
  • Page 85 Acquiring CEPH Images Setting the Exposure Parameters ........86 Positioning the Patient ............89 7.2.1 Lateral Mode (QR Code)............90 7.2.2 Frontal Mode (PA)..............92 7.2.3 SMV Mode ................94 7.2.4 Waters View Mode ..............95 7.2.5 CARPUS Mode ..............96 Initiating X-Ray Exposure ............ 98...
  • Page 86: Acquiring Ceph Images

    B. Select the scanning mode under CEPH Examination. – Lateral, PA, SMV, Waters View, Carpus. C. Exposure time Exposure time can be adjusted by resolution of 0.1 s in the range of 0.7 s to 1.2 s (One-shot type only). PaX-i (PCH-2500) User Manual...
  • Page 87 X-ray intensity. If necessary, you may manually adjust these values using the arrows to the right of each value. Adjustable resolution: - Tube voltage: ± 1 kVp NOTE - Tube current: ± 1 mA G. Click Confirm to accept the parameters. PaX-i (PCH-2500) User Manual...
  • Page 88 ■ The scan time and estimated DAP (Dose Area Product) value are shown on the main display for the intended exposure. H. Guide the patient to the equipment. Refer to section 7.3: Positioning the Patient. PaX-i (PCH-2500) User Manual...
  • Page 89: Positioning The Patient

    NOTE Ensure that the nasal positioner left unfolded, before adjusting the ear rods in the proper direction. CAUTION Ensure that the patient is clear of all moving parts while adjusting the height of the equipment. WARNING PaX-i (PCH-2500) User Manual...
  • Page 90: Lateral Mode

    C. Ask the patient to stand upright. Make sure that the patient’s shoulders are level and that their neck is relaxed. D. Adjust the height of the unit to suit the patient by pressing the column up/down button or switch (optional). PaX-i (PCH-2500) User Manual...
  • Page 91 H. Click the Ready button after the patient has been properly positioned. No X-Ray will be emitted at this point. The CEPH sensor and the 2 collimator will enter positioning mode. I. Proceed to section 7.4: Initiating X-Ray Exposure. PaX-i (PCH-2500) User Manual...
  • Page 92: Frontal Mode (Pa)

    NOTE C. The nasal positioner should be flipped to the side and upward to prevent it from obstructing the image acquisition. Nasal positioner D. Guide the patient to the CEPH unit. PaX-i (PCH-2500) User Manual...
  • Page 93 I. Click the Ready button after the patient has been positioned. No X-Ray will be emitted at this point. The CEPH sensor and the 2 collimator will enter capturing mode. J. Proceed to section 7.4: Initiating X-Ray Exposure. PaX-i (PCH-2500) User Manual...
  • Page 94: Smv Mode

    E. Adjust the height of the unit to suit the patient by pressing the column up/down button or switch (optional). After adjusting the column to suit the height of the patient, fit the ear rods along the patient’s ear canals. CAUTION PaX-i (PCH-2500) User Manual...
  • Page 95: Waters View Mode

    E. Adjust the height of the unit to suit the patient by pressing the column up/ down button or switch (optional). After adjusting the column to suit the height of the patient, fit the ear rods along the patient’s ear canals. CAUTION PaX-i (PCH-2500) User Manual...
  • Page 96: Carpus Mode

    I. Proceed to section 7.4: Initiating X-Ray Exposure. 7.2.5 CARPUS Mode Attaching the CARPUS plate A. Match the notch on the CARPUS plate Locking bolt to the end of the nasal positioner. Nasal positioner Fixed bolt Ruler Notch CARPUS Plate PaX-i (PCH-2500) User Manual...
  • Page 97 / her fingers. It could deteriorate image CAUTION quality. C. Click the Ready button after the patient has been properly positioned. No X-Ray will be emitted at this point. D. Proceed to section 7.4: Initiating X-Ray exposure. PaX-i (PCH-2500) User Manual...
  • Page 98: Initiating X-Ray Exposure

    - The operator shall observe the X-Ray safety regulations WARNING applicable to their area at all times during the operation of this equipment. If an emergency occurs during image acquisition, release the exposure switch to cease X-Ray emission. CAUTION PaX-i (PCH-2500) User Manual...
  • Page 99 D. The captured image will be automatically transferred to EasyDent. Clicking the patient’s name in the patient list after imaging will refresh the image list for that patient. The patient’s most recent image will appear on the far left of the thumbnail image pane. PaX-i (PCH-2500) User Manual...
  • Page 100 After Image Acquisition After the image has been acquired, perform the following tasks: ■ Fold away the nasal positioner. ■ Loosen the ear rod supports and remove them from the patient’s ears. ■ Release the patient. PaX-i (PCH-2500) User Manual...
  • Page 101 Troubleshooting...
  • Page 102: Troubleshooting

    - If a severe problem occurs during image acquisition, WARNING press the red emergency stop button to immediately stop all moving parts and cut off all power to the equipment’s electrical components. You may then safely release the patient from the equipment. PaX-i (PCH-2500) User Manual...
  • Page 103 Cleaning and Maintenance Cleaning ................104 Maintenance ..............105...
  • Page 104: Cleaning And Maintenance

    Clean the chin support using an alcohol-based Chin support disinfectant before each patient is X-rayed. All components that Clean components using an alcohol-based come into contact with disinfectant before each patient is X-rayed. the patient or operator PaX-i (PCH-2500) User Manual...
  • Page 105: Maintenance

    9.2 Maintenance VATECH requires periodic constancy tests to ensure image quality and the safety of 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 106 Ensure that all visible labels are intact and legible. Monthly Check for possible wear or damage to the exposure switch Monthly cable. Confirm that the audio message is audible throughout the Monthly duration of the exposure. PaX-i (PCH-2500) User Manual...
  • Page 107: Disposing Of The Unit

    Disposing of the Unit...
  • Page 108 ● Paper ● X-Ray tube ● Sensor head Return the sensor head to VATECH Other parts ● Please observe all regulations relevant to the disposal of waste in your country. NOTE This dental equipment shall not be disposed of as domestic garbage materials.
  • Page 109 Technical Specifications 11.1 Mechanical Specifications ..........110 11.2 Technical Specifications ............ 113 11.3 Electrical Specifications ............. 117 11.4 Environmental Specifications ..........118...
  • Page 110: 11. Technical Specifications

    FDD : Focal Spot to Detector Distance FOD : Focal Spot to Object Distance ODD : Object to Detector Distance (ODD = FDD - FOD) Magnification = FDD / FOD B. Dimension - Without Cephalometric Unit & Non-Base type [Unit: mm (Inches) PaX-i (PCH-2500) User Manual...
  • Page 111 11. Technical Specifications - With Cephalometric Unit & Non-Base type [Unit: mm (Inches) - Without Cephalometric Unit & Base type [Unit: mm (Inches)] PaX-i (PCH-2500) User Manual...
  • Page 112 11. Technical Specifications - With Cephalometric Unit & Base type [Unit: mm (Inches)] - Common Dimension(Non-Base type) - Common Dimension(Base type) [Unit: mm (Inches)] PaX-i (PCH-2500) User Manual...
  • Page 113: Technical Specifications

    Description Model HDG-07B10T2 Rated output power 0.99 KW Type 40 KHz Inverter Type 50 ~ 90 Normal/ High voltage Pulse 4 ~ 10 generator Automatically controlled / Protect Cooling ≥ 60 ℃ Air Cooling : Optional PaX-i (PCH-2500) User Manual...
  • Page 114 35 kJ 1:60 or more Duty Cycle (Exposure time : interval time) Maximum Rating Charts DC (Center Grounded) Constant potential high-voltage generator Nominal Focus Spot Value: 0.5 70kV 80kV 60kV 90kV 50kV 100kV EXPOSURE TIME [s] PaX-i (PCH-2500) User Manual...
  • Page 115 11. Technical Specifications Emission & Filament Characteristics Constant potential high-voltage generator Nominal Focus Spot Value: 0.5 80kV 100kV 50kV FILAMENT CURRENT [A] Anode Thermal Characteristics 175 W COOLING HEATING TIME (min) PaX-i (PCH-2500) User Manual...
  • Page 116 11. Technical Specifications Tube Housing Assembly Thermal Characteristics Tude Anode Thermal Characteristics PaX-i (PCH-2500) User Manual...
  • Page 117: Electrical Specifications

    - AC 240 V (Australia) Frequency 50 / 60 Hz (Single) Power rating Max.2.0 kVA ■ The input line voltage depends on the local electrical distribution system. ■ Allowable input voltage fluctuation requirement: ± 10 %. PaX-i (PCH-2500) User Manual...
  • Page 118: Environmental Specifications

    10 ~ 35 ℃ During operating Relative humidity 30 ~75 % Atmospheric pressure 860 ~ 1060 hPa Temperature -10 ~ 60 ℃ 10 ~ 75 % Transport and storage Relative humidity non condensing Atmospheric pressure 860 ~ 1060 hPa PaX-i (PCH-2500) User Manual...
  • Page 119 Appendices Recommended X-Ray Exposure Table ....120 X-Ray Dose Data ........... 122 DAP Table ................. 122 X-ray Leakage Dose ............123 X-Ray Scatter Dose ............125 Electromagnetic Compatibility (EMC) Information ........... 126 Acquiring image for the pediatric dental patient ............130 Age group: classification table ........
  • Page 120: Recommended X-Ray Exposure Table

    90 / 10 87 / 10 90 / 10 86 / 10 89 / 10 85 / 10 Child 86 / 10 83 / 10 85 / 10 82 / 10 84 / 10 81 / 10 PaX-i (PCH-2500) User Manual...
  • Page 121 - Maximally allowed tube voltage / current: kVp ± 10 % / mA ± 20 % according to IEC60601-2-7. - Due to image optimization performed prior to shipping, NOTE equipment data may differ slightly from those specified in the table. PaX-i (PCH-2500) User Manual...
  • Page 122: X-Ray Dose Data

    VATECH dental diagnostic system meets all requirements specified in the IEC Collateral Standard. To limit unnecessary exposure to the patient, operator or other staff, the PaX-i is designed to comply with IEC 60601-1-3 Part 1 General Requirements for Safety. Test Condition...
  • Page 123: X-Ray Leakage Dose

    Mode PANO PANO CEPH CEPH (HD, Adult) (HD, Child) (Scan type) (One-shot type) [mR/hr] Direction [°] 15.2 15.9 15.1 16.7 20.1 17.6 18.5 21.2 40.5 33.2 37.3 34.3 67.8 66.8 68.9 71.2 61.1 19.3 34.5 39.5 PaX-i (PCH-2500) User Manual...
  • Page 124 16.9 26.9 20.7 18.2 23.7 30.6 50.7 13.3 15.6 29.3 74.8 12.9 11.2 26.8 70.6 11.3 10.1 21.5 60.1 11.7 11.8 16.0 35.1 17.5 12.9 12.8 19.2 11.9 11.3 14.2 12.9 10.9 10.6 11.3 10.3 10.4 PaX-i (PCH-2500) User Manual...
  • Page 125: X-Ray Scatter Dose

    (4.9 ft) (6.6 ft) 15.3 9.76 2.32 35.3 22.9 16.5 70.6 40.8 21.8 Mode PANO UHD, 16.6 s [mR/hr] 1.5 m Direction [°] (3.3 ft) (4.9 ft) (6.6 ft) 63.9 38.8 29.5 13.4 7.74 19.6 10.1 6.33 PaX-i (PCH-2500) User Manual...
  • Page 126: Electromagnetic Compatibility (Emc) Information

    (EMC) Information Guidance and manufacturer’s declaration - electromagnetic emissions. The model PaX-i(PCH-2500) is intended for use in the electromagnetic environment specified below. The customer or the user of the model PaX- i(PCH-2500) should assure that it is used in such an environment.
  • Page 127 Appendices Guidance and manufacturer’s declaration - electromagnetic immunity The model PaX-i(PCH-2500) is intended for use in the electromagnetic environment specified below. The customer or the user of the model PaX- i(PCH-2500) should assure that it is used in such an environment.
  • Page 128 Guidance and manufacturer’s declaration - electromagnetic immunity The model PaX-i(PCH-2500) is intended for use in the electromagnetic environment specified below. The customer or the user of the model PaX-...
  • Page 129 If abnormal performance is observed, additional measures may be necessary, such as relocating the model PaX-i(PCH-2500) or using a shielded location with a higher RF shielding effectiveness and filter attenuation. PaX-i (PCH-2500) User Manual...
  • Page 130: Acquiring Image For The Pediatric Dental Patient

    2. Move chinrest into a position that is slightly higher than the patient’s chin height before requesting that the patient place chin on the rest. Direct the patient to assume a position that resembles the erect stance of a soldier. PaX-i (PCH-2500) User Manual...
  • Page 131: Setting Exposure Values To The Age Group

    2-3 years interval should be considered when caries activity/risk is low. A routine survey by radiographs, except for caries, has not been shown to provide sufficient information to be justified considering the balance between cost (radiation and resources) and benefit. PaX-i (PCH-2500) User Manual...
  • Page 132 MDCT examinations with a 6-year-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 concern about radiation dose and their risks to children. PaX-i (PCH-2500) User Manual...
  • Page 133 32.7 mGy for lens in brain 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. PaX-i (PCH-2500) User Manual...
  • Page 134: Abbreviations

    International Standards Organization Light-Emitting Diode MPSO Multiple Portable Socket-Outlet Object to detector distance Posterior/Anterior Radio Frequency Region of Interest Source to Image receptor Distance Signal Input Part Signal Output Part Submento-Vertical Temporomandibular Joint Ultra High Definition PaX-i (PCH-2500) User Manual...
  • Page 135 The CE symbol grants this product compliance to the European Directive for Medical Devices 93/42/EEC as 2460 amended by 2007/47/EC as a class II b device. EC Representative; Vatech Dental Manufacturing Ltd. Suite 3, Ground Floor, Chancery House, St. Nicholas Way, Sutton, SM1 1JB UK Tel: +44-0208-652-1900, +44-0208-643-7109...
  • Page 137 Postal code: 18449 13, Samsung 1-ro 1-gil, Hwaseong-si, Gyeonggi-do, Korea www.vatech.co.kr...

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