Acteon X-MIND prime User Manual
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Acteon X-MIND prime User Manual

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X-MIND prime
User Manual
USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C

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Summary of Contents for Acteon X-MIND prime

  • Page 1 X-MIND prime User Manual USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 3: Table Of Contents

    6.2 Tube loading curves, anode heating and cooling curves 6.3 PC requirements 6.3.1 PC minimum characteristics 6.4 Software 6.5 X-MIND prime – PC communication 6.6 Reference standard 7. QUALITY ASSURANCE PROGRAM USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 4 8.10.3 Carrying out the first exposure 8.10.4 TMJ open mouth: preparation of the patient 8.10.5 Carrying out the second exposure 8.11 Table of pre-set anatomic parameters 9. ERROR MESSAGES USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 5 11.2.6 Spine effect Note No part of this publication can be reproduced, transmitted, transcribed or translated without the approval of ACTEON. This manual in English is the original Manual version. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 6 User Manual – Contents THIS PAGE IS INTENTIONALLY LEFT BLANK USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 7: Introduction

    Please read this Manual thoroughly before starting to use the unit; it is advisable to keep the manual close to the device, for reference while operating. X-MIND prime is an electrical medical device and can only be used under the supervision of a physician or of highly qualified personnel, with necessary knowledge of X-ray protection.

  • Page 8: Specification Of The Intended Use

    User Manual – Specification of the intended use SPECIFICATION OF THE INTENDED USE Application and medical purpose X-MIND prime is an extra-oral dental panoramic X-ray unit to radiograph teeth, jaw and oral structures. The device is operated and used by dentists, radiologists and other legally qualified health care professionals.

  • Page 9: Applied Parts

    User Manual – Specification of the intended use Applied parts During normal use, X-MIND prime is in contact with the patient via the handle, the chin rest and bite and the temple clamp, classified as Type B applied parts. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 10: Typical Doses Delivered To The Patient During Extra-Oral Exams

    Child low dose 0.77 0.55 Half-panoramic 0.85 Low Dose 0.90 Ortho Rad panoramic 0.33 Frontal dentition Bitewing L or R 0.24 0.47 Bitewing L and R 0.71 0.65 Sinus USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 11 User Manual – Specification of the intended use The dose per area of products delivered by X-MIND prime to the patient during extra- oral exams is indicated in the graphical user interface. Note The dosimetric indications result from the average of dose measures on a lot of X-rays source assemblies.

  • Page 12: Safety Information

    One copy of User and Service Manual are always provided with the unit. Warning In compliance with the IEC 60601-1 standard, the modification of the equipment or its parts is strictly prohibited. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 13: Warnings

    Before performing any maintenance operation, disconnect the unit from the power supply. X-MIND prime is an electric medical device and so can only be used under the supervision of suitably qualified medical personnel, with necessary knowledge of X-ray protection.

  • Page 14: Precautions While Using Laser Centring Devices

    A laser in class 2 can be potentially dangerous if the ray is reflected into not protected eyes by a mirror, watch, a ring etc. The warning label below is affixed to X-MIND prime to indicate a laser in class 2 is mounted internally and caution is advised: Warning •...

  • Page 15: Protection Against Radiation

    2 m both from the X-ray source and from the patient, as shown in the following figure. Minimum distance from X-ray source 2 m Protected area Figure 1 USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 16: Pediatric Use: Summary

    HTTPS://WWW.IAEA.ORG/RESOURCES/RPOP/RESOURCES/TRAINING- MATERIAL#3 3.2.1.3 Device specific features and instructions X-MIND prime provides as standard with all units, the following specific design features and instructions that enable safer use of our device with pediatric patients: Design features important to paediatric imaging Paragraph Adult/Child exam modality: child selection adapts exposure 8.4 and 8.11...

  • Page 17: Information About Electromagnetic Compatibility

    Warning X-MIND prime should not be used adjacent to or stacked with other equipment; if adjacent use is necessary, X-MIND prime has to be observed to verify if it operates in a normal way. Interference may occur in the vicinity of equipment marked with the symbol...

  • Page 18: Electromagnetic Emissions

    User Manual – Safety information 3.3.1 Electromagnetic emissions In accordance with the IEC 60601-1-2 Ed4 standard, X-MIND prime is suitable for use in the electromagnetic environment specified below. The customer or user of the system must ensure that it is used in the said environment.

  • Page 19: Electromagnetic Immunity

    User Manual – Safety information 3.3.2 Electromagnetic immunity In accordance with the IEC 60601-1-2 Ed4 standard, X-MIND prime is suitable for use in the electromagnetic environment specified below. The customer or user of the system must ensure that it is used in the said environment.

  • Page 20: Cybersecurity Measures

    Like all computer-based systems, X-MIND prime might be exposed to Cybersecurity threats. X-MIND prime is equipped with hardware provisions that make sure that no unwanted X-ray exposure, laser radiation or motorized movements can be activated even in case of cyber-attack or software failure.

  • Page 21: Environmental Risks And Disposal

    Illegal disposal of the product by the owner of the equipment will result in administrative sanctions, as provided for by applicable regulations. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 22: Symbols Used

    User Manual – Safety information Symbols used In this manual and on X-MIND prime itself, apart from the symbols indicated on the keyboard, the following icons are also used: Symbols Description Device with type B applied parts Some parts of the device contain materials and liquids that, at the end of the unit's lifecycle, must be disposed of at appropriate disposal centres.
  • Page 23 Exposure enabled status (the corresponding green LED is on) X-Ray emission (the corresponding yellow LED is on) Electronic instructions for use symbol for medical devices, according to EN ISO 15223-1: 2016 USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 24: Cleaning And Disinfection

    To ensure a greater level of hygiene the handles of the equipment are covered with a special antibacterial paint which, thanks to the emission of silver ions, prevents the development of micro-organisms. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 25: Description

    User Manual – Description DESCRIPTION Identification labels and laser labels 1a, 1b, 4 Figure 2: Identification labels USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 26: Identification Labels And Laser Labels

    User Manual – Description 5.1.1 Identification labels and laser labels X-MIND prime UDI label identification label Tube-head identification label (No. 2) Laser symbol label Laser WARNING label WARNING label Emergency button label USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 27: Functions, Models And Versions

    Identification Code (UIC); in the event the UIC is not present or is faulty, error E270 or E271 will be shown. The UIC is simply an identifier of the single X-MIND prime unit and is generated by Acteon for the single device serial number.

  • Page 28: Technical Characteristics

    60 - 70kVp, with 2 kVp steps Anodic current 2 - 7.1mA, with R20 scale steps (2, 2.2, 2.5, 2.8, 3.2, 3.6, 4, 4.5, 5, 5.6, 6.3, 7.1) ≥ 2 mm Al eq. Additional filtration USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 29 Low dose panoramic • Frontal dentition • Bitewing L/R • Bitewing L and R TMJ (Temporal Mandibular Joint) exam TMJ open and closed mouth Sinus exam Sinus P/A projection USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 30 The declared image magnification value is valid after proper software calibration. Note X-MIND prime is based on a standard dentition and ascending rami shape. This shape, based on statistical studies, establishes a form for the dentomaxillofacial complex, adopted as "standard".
  • Page 31 Leakage radiation at 1 m < 0.5 mGy/h @ 70 kVp - 7.1 mA - 3s duty cycle 1/16 Tube-head maximum thermal capacity 310kJ Figure 3: Tube-head target angle (view from the bottom) USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 32 146 x 6 mm Pixel dimension 48 µm, 96 µm in 2x2 binning Number of pixels 3072x128 Spatial resolution 4 lp/mm Sensor cover attenuation equivalent < 0.4 mm Al eq. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 33 Note The handles of the equipment are covered with a special antibacterial paint which, thanks to the emission of silver ions, prevents the development of micro- organisms. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 34: Dimensions

    User Manual – Technical characteristics Dimensions 797 (31.4") 953 (37.5") Figure 4: X-MIND prime dimensions - Wall mounted version USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 35 User Manual – Technical characteristics 797 (31.4") 400 (15.8") 100 (3.9") 953 (37.5") Figure 5: X-MIND prime dimensions - Wall mounted with floor support version USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 36 User Manual – Technical characteristics 962 (37.9") 790 (31.1") 996 (39.2") 953 (37.5") Figure 6: X-MIND prime dimensions - Floor mounted version USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 37: Tube Loading Curves, Anode Heating And Cooling Curves

    User Manual – Technical characteristics Tube loading curves, anode heating and cooling curves Tube "Canon D-058" (0.5 IEC 336) Tube loading curves Anode heating and cooling curves USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 38 User Manual – Technical characteristics Tube "CEI OPX 105-12" (0.5 IEC 336) Tube loading curves Anode heating and cooling curves USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 39 User Manual – Technical characteristics Tube head cooling curve USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 40: Pc Requirements

    10/100 Ethernet port. Note Monitor characteristics: the PC and the monitor are not supplied with the equipment. In order to properly view images taken with X-MIND prime, the PC monitor must have the following minimum characteristics: • Resolution: 1366 x 768 pixels •...

  • Page 41: Software

    In case of replacement, a cable of the same or superior category has to be used. If the communication between X-MIND prime and PC is not properly set problems in unit connection causing impossibility of acquisition or loss of data causing distortion and artefacts on the images can occur.

  • Page 42: Reference Standard

    IEC 60825-1:1993 (1nd ed.) Safety of laser product – Part 1: equipment classification and requirements. IEC 60825-1:2007 (2nd ed.) Safety of laser product – Part 1: equipment classification and requirements. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 43 Fax: +39 0331 376763 Classifications X-MIND prime is an electrical medical X-ray device classified as class I type B according to EN 60601-1, with continuous operation at an intermittent load. According to 93/42/EEC Medical Devices Directive, the equipment is classified as class II B.

  • Page 44: Quality Assurance Program

    Functioning of the indicator lights User Paragraph 7.2 Daily Laser alignment check User Paragraph 7.3 Monthly Image quality check User Paragraph 7.4 Yearly Dosimetry test Authorized Paragraph 7.5 personnel USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 45: Quality Check Tools

    (NOT provided with the equipment): used to measure exposure parameters. Except kV meter, all these tools are provided with the unit. Centering tool (P/N 6195170200) Support plate (P\N 6195170100) Figure 7: Support plate and centering tool positioning USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 46: Functioning Of The Indicator Lights

    Laser correctly aligned Laser misaligned Figure 9 In case the test fails, repeat it checking that there is no mechanical interference. If misalignment is still present, call technical assistance. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 47: Image Quality Check

    Open AIS software and open the patient "Quality Test". If not present, create a new patient (Name: "Quality"; Family name: "Test"). From the top toolbar, select the Panoramic icon to open the X-MIND prime interface USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 48 2mm. In case the test fails, call technical assistance. Record the tests results in the log book at paragraph 7.6.1. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 49: Signal To Noise Check

    Open SyMage program and open the image previously saved on the Desktop. Select the tool "Rectangle Selection" from the palette, and draw a region on the uniform area of the centering tool as shown in the figure below: USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 50 Check the window "Statistics": the S\N (db) value has to be higher than 25. Record the test results in the log book at paragraph 7.6.1. In case the tests fail, call technical assistance. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 51: Dosimetry Test (Paragraph For Authorised Personnel)

    Place the probe of the dosimeter on the sensor plastic cover. Open the PhD_Test software (located at C:\Program Files (x86)\Acteon Imaging\Panoramic X-MIND prime) and check that the unit is connected to the PC (the message "MCU is connected" is displayed in the bottom left corner of the program window).
  • Page 52 Service manual, paragraph 9.7 • If the values are still out of range, call technical assistance. Record the test results in the log book at paragraph 7.6.2. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 53: Log Book

    LOG book 7.6.1 Image quality check Dimension Symmetry Signal to noise  2 mm ≥ 25 dB Acceptance range-> 167 - 171 mm Date Measured value Measured value Measured value USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 54: Verification Of Radiological Parameters

    60 kV, 3 mA, 3 s 70 kV, 6 mA, 3 s Acceptance 55.2-64.8 kV 2.85-3.15 s 64.4-75.6 kV 2.85-3.15 s range-> Date kV measured Time kV measured Time measured measured USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 55: General Instructions For Use

    In case of an emergency column situation, press the emergency button to stop the movement. If columns don't move, check that the emergency button is not pressed; rotate the button to release it. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 56: Positioning The Chin Support

    User Manual – General instructions for use Positioning the chin support X-MIND prime is equipped with different types of supports: a standard support fitted with a special removable appendix for edentulous patients, a lower one for SINUS exams and a third one TMJ exams.

  • Page 57: Keyboard - Description And Functions

    Green blinking slowly, indicates that by pressing >O< button, axis reset will start, • Green blinking fast, indicates the equipment cooling status. Light indicator "X-Ray Emission" status. It indicates the emission of X-rays. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 58 The "Centring/Patient Entrance" key is used to: • Start/Stop the exam procedures • Put the rotation arm in the patient entrance position at the end of the exam. Temple clasps closing/release knob. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 59: Graphical User Interface - Description And Functions

    Test mode may also be useful when the equipment is used on child patients, to show them how the equipment works before running the exam. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 60 "Anatomic" to "Manual". Return to "Anatomic mode" using the main programme selection key. Main menu: selects exam modality, exam type and sub-menu including the available exams. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 61: Main Gui Area Functions

    Close to the virtual display there are three different keys that may be selected by the user: Settings, Test mode (enable/disable), HD mode (enable/disable) USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 62: Digital Sensor

    User Manual – General instructions for use Digital sensor The new X-MIND prime is equipped with a PAN sensor: it is a sensor suitable for Panoramic-type imaging, i.e. all images with about 14cm-high field; all Panoramic, TMJ, and Sinus images belong to this type.

  • Page 63: Making An Exam

    In general with child and adolescent patients, before taking the exposure it is suggested to run the exam in test mode in such a way to show the young patient how the unit works and make them feel comfortable. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 64: Anatomic / Manual Exposure

    MANUAL: with the possibility to vary the kV and mA values already set. Note The exam parameters set as the default are values to be taken as the starting point. Users can optimise the parameters according to their needs. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 65: Anatomic Exposure

    The kV value can vary between 60 and 70 kV, with 2 kV steps. The mA value can vary between 2 and 7.1 mA according to the r20 scale. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 66: Panoramic And Bitewing Exams

    Frankfurt plane line: plane that identifies a line that ideally connects the hole in the auricular canal – external auditory meatus - with the bottom edge of the orbital fossa Figure 12 USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 67: Preparation Of The Device

    Select the type of build with the Patient Size icons (Small - Medium - Large). Select the type of biting with the Dentition icons (Protruded - Normal - Retracted) USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 68 The exam parameters set as the default are values to be taken as the starting point. Users can optimise the parameters according to their needs. Once the settings have been completed, the chin support must be placed in position. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 69 The following selections are possible for the Half Panoramic exam range: < R (Right) - L (Left) > The selection is done clicking on the corresponding side of the image Figure 15: Half Panoramic Right selection USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 70 Selecting "Single" are possible the following exam options: < R (Right) - L (Left) > The selection is done clicking on the corresponding side of the image Figure 17: Right Bitewing selection USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 71 User Manual – General instruction for use Note The new X-MIND prime is based on a standard dentition and ascending rami shape. This shape, based on statistical studies, establishes a form for the dentomaxillofacial complex, adopted as "standard". X-MIND prime follows a...
  • Page 72 As a consequence of the different trajectory, the focus layer, mainly in the front teeth area, is smaller and patient positioning for this exam needs more care. Follow the instructions for normal panoramic exams for patient positioning. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 73 This exam is normally used when it is already known that the patient has a problem on the bite-sectors of the arch, so it is possible to reduce patient irradiation. Follow the instructions for normal panoramic for patient positioning. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 74: Preparation Of The Patient

    118 cm (3 ft 10.4") high. Label Description Sagittal medial line Frankfurt line Panoramic chin rest Centring bite Temple claps closing/release knob Laser Knob Figure 18: Patient positioning USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 75 Once alignment has been completed, the green LED "Ready for X-ray" (3 Figure 10 ) lights up to indicate that pressing the X-ray button once more will start the radiation phase. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 76 In general with child and adolescent patients, before taking the exposure it is suggested to run the exam in test mode in such a way to show the young patient how the unit works and make them feel comfortable. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 77: Taking An Exposure

    GUI) and the acoustic ray signal. The Digital Acquisition System will, in the meantime, process the image. Figure 19 At the end of the acquisition, the GUI will be replaced by the acquired image. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 78 User Manual – General instructions for use Note X-MIND prime assumes that the digital sensor is ready: if this is not the case, the blue light indicator of "Computer connection" status (5 - Figure 10) start blinking slowly. Note The rotation of the arm and the emission of the X-rays will start with a delay of about 3 seconds from when the X-ray button is pressed.
  • Page 79 IEC 60601-2-63, the maximum deviation (including the correction according to the above curve and instrumental doubt) is within ±10% for the kV, while for the tube current it is within ±15%. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 80: Image Processing Windows

    The Image Processing menu, if activated, will be displayed at the end of the acquisition in order to customize the default image post-processing settings. The feature can be either enabled or disabled through the corresponding option available under Settings. Figure 20 USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 81 The default post-processing can be modified through dedicated toolbars, from the top respectively: • brightness • contrast • gamma value • image enhancement. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 82 (Figure 22). The button 4 is set as default to load the original image (without post-processing) and it can be fully customized as above described. Figure 22 USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 83: Sinus Exam

    On the basis of the selections made, the display will visualize the kV and mA settings as in the table: Exposure values in SINUS mode Adult Patient Child Patient (9.4 seconds) (9.4 seconds) Small Medium Large USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 84 Once the settings have been completed, the chin support must be placed in position. Note X-MIND prime is based on a standard dentition and ascending rami shape. This shape, based on statistical data, establishes a standard shape for the dentomaxillofacial complex, also defining the position and the direction of the condyles.

  • Page 85: Preparation Of The Patient

    118 cm (3 ft 10.4") high. Label Description Sagittal medial line Frankfurt line Sinus positioner Temple claps closing/release knob Laser knob Figure 24: SINUS positioning USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 86 In general with child and adolescent patients, before taking the exposure it is suggested to run the exam in test mode in such a way to show the young patient how the unit works and make them feel comfortable. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 87: Taking An Exposure

    During the exam, one single rotation of the rotating arm is to be expected, with X-ray emission limited to the area concerned. Note X-MIND prime assumes that the digital sensor is ready: if this is not the case, the blue light indicator of "Computer connection" status (5 - Figure 10) start blinking slowly.
  • Page 88 After each exam, clean the chin support, the handles and the temple clasps group thoroughly and change the disposable bite protective sleeve. Follow instruction on paragraph 8.8.5 to perform image processing function. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 89: Tmj Exam

    Figure 25 shows the information related to the single sectors. RIGHT condyle RIGHT condyle LEFT condyle LEFT condyle with closed mouth with open mouth with open mouth with closed mouth exposure exposure exposure exposure Figure 25: TMJ Standard USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 90 In the CHILD position, the start of exposure is delayed by a few degrees compared to the ADULT position. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 91: Preparation Of The Device

    MEDIUM SIZE with the display of the corresponding graphic for the key • default exposure parameters (if this is the first TMJ exposure), or the exposure parameters (kV and mA) of the last exposure performed. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 92 The exam parameters set as the default are values to be taken as the starting point. Users can optimise the parameters according to their needs. Once the settings have been completed, the chin support must be placed in position. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 93 User Manual – General instruction for use Note X-MIND prime is based on a standard dentition and ascending rami shape. This shape, based on statistical data, establishes a standard shape for the dentomaxillofacial complex, also defining the position and the direction of the condyles.

  • Page 94: Tmj Closed Mouth: Preparation Of The Patient

    118 cm (3 ft 10.4") high. Label Description Sagittal medial line TMJ positioner Temple claps closing/release knob Laser knob Figure 29 – TMJ closed mouth positioning USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 95 In general with child and adolescent patients, before taking the exposure it is suggested to run the exam in test mode in such a way to show the young patient how the unit works and make them feel comfortable. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 96: Carrying Out The First Exposure

    The Digital Acquisition System will, in the meantime, process the image. Note X-MIND prime assumes that the digital sensor is ready: if this is not the case, the blue light indicator of "Computer connection" status (5 - Figure 10) start blinking slowly.
  • Page 97 Press the "Patient Entrance" key (6 - Figure 10). The equipment will reposition itself in the starting position. In TMJ Standard examination, at the end of the movement, the message "Instruct patient to open mouth" will be displayed. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 98: Tmj Open Mouth: Preparation Of The Patient

    118 cm (3 ft 10.4") high. Label Description Sagittal medial line TMJ positioner Temple claps closing/release knob Laser knob Figure 30: TMJ open mouth positioning USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 99 In general with child and adolescent patients, before taking the exposure it is suggested to run the exam in test mode in such a way to show the young patient how the unit works and make them feel comfortable. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 100: Carrying Out The Second Exposure

    At the end of the acquisition, the GUI will be replaced by the acquired image. Note X-MIND prime assumes that the digital sensor is ready: if this is not the case, the blue light indicator of "Computer connection" status (5 - Figure 10) start blinking slowly.

  • Page 101: Table Of Pre-Set Anatomic Parameters

    Medium Large Large Note The exam parameters set as the default are values to be taken as the starting point. Users can optimise the parameters according to their needs. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 102: Error Messages

    Zero position micro Y never active Timeout on Y axes Disk collimator Code Error description Collimator timeout on zero positioning Hardware keyboard (U.I.C.) Code Error description 270 / 271 Hardware key fault USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 103 Generator board reset due to a stack overflow Mismatch between generator board (A2) and MCU board (A1) types (2D / 3D) Keyboard Code Error description One or more keycodes are pressed Button >O< pressed during movements USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 104 PC driver interface (OSP / VSP) Code Error description 1401 Sensor frame lost during exam 1402 Sensor configuration failure 1403 Software watchdog error 1404 Sensor does not detect X-rays during exam USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 105: Maintenance

    Check that arm movement is smooth Practical inspection Monthly Integrity of equipment and labels Visual inspection Warning If the operator detects irregularities or failures, he must immediately call Technical Service. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 106 Correct equipment centring (according to the Service Manual paragraph 9.3.2) Annually Check technical factors (according to paragraph 7.5) Annually Perform sensor calibration Annually Check that the fixing screws are tightened USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 107: Panoramic Image Assessment

    Maxilla and maxillary tuberosity Temporo mandibular condyle Ascending ramus of the TMJ Coronoid process (overlap with maxilla) Mandibular canal Chin foramen Anterior nasal spine Nasal cavities Ioid bone (normally duplicated) USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 108: Proper Positioning Of The Patient

    If not properly extended, the spine will cause the appearing of a lower exposed area (clearer) in the front part of the image. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 109 Any flaring of dentition may not allow crowns and apices of both arches to fit in the image layer at the same time. For these patients, you must purposely move him/her further forward in order to move the apices into the image layer. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 110: Patient Positioning Errors

    The patient's head is turned to one side (left or right) in the mid-sagittal plane. Effects Condyles are different in size. The ramous on one side is much wider that the other one. Asymmetric spine compensation. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 111: Tilted Head

    Figure 35 Problem The patient's head is tilted to one side. Effects One condyle appears higher than the other one and the inferior border of the mandible is slanting. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 112: Downward Angulation Of The Head

    The shadow of the hyoid bone is typically superimposed on the anterior mandible. Condyles may be cut off at the top of the radiograph. Pre-molars are severely overlapped. Severe curvature of the occlusal plane. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 113: Backward Angulation Of The Head

    The hard palate is superimposed over the apices of the maxillary teeth. Both condyles may be off the edges of the image area. The upper incisors can be blurred. Flattening of the occlusal plane. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 114: Tongue Effect

    Effects A dark air space between the dorsum of the tongue and the hard and soft palates (palatoglossal air spaces) obscures the apical region of the maxillary teeth. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...

  • Page 115: Spine Effect

    Spine effect Figure 39 Problem The patient is slumped. Effects The spinal column isn't well stretched causing a ghost image of the spine superimposed in the centre of the image. USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 116 Technician Maintenance: Date Technician Cause Maintenance: Date Technician Cause Maintenance: Date Technician Cause Maintenance: Date Technician Cause Maintenance: Date Technician Cause Maintenance: Date Technician Cause Maintenance: Date Technician Cause USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C...
  • Page 118 0051 de Götzen S.r.l. Via Roma 45 • 21057 OLGIATE OLONA (VARESE) • ITALY Tel +39 0331 376 762 • Fax +39 0331 376 763 E-mail: imaging.italysupport@acteongroup.com • www.acteongroup.com...

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