Acteon X-MIND trium User Manual
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Acteon X-MIND trium User Manual

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USER MANUAL

CMJN : 15/0/0/85
CMJN : 80/0/10/0
USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M
Pantone 432C
Pantone 306C
RAL 7024 (Graphite gr
RAL 220 80 25

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  • Page 1: User Manual

    USER MANUAL CMJN : 15/0/0/85 Pantone 432C RAL 7024 (Graphite gr CMJN : 80/0/10/0 Pantone 306C RAL 220 80 25 USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...
  • Page 2 SOUTH AMERICA ACTEON LATIN AMERICA info@es.acteongroup.com TAIWAN ACTEON TAIWAN info@tw.acteongroup.com THAILAND ACTEON THAILAND info@th.acteongroup.com U.K. ACTEON UK info@uk.acteongroup.com INITIAL IMPORTER / US AGENT ACTEON INC info@us.acteongroup.com OR THE MANUFACTURER AT imaging.italysupport@acteongroup.com USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...
  • Page 3 Important: All new editions and revisions of the manuals supersede the previous ones Refer to complete manuals and For complete manuals Scan the QR code to access the instructions and instructions dedicated website www.acteongroup.com www.acteongroup.com USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...

  • Page 4: Table Of Contents

    6.2 PATIENT POSITIONING ---------------------------------------------------------------------------------------------------------------37 6.3 EXECUTION OF THE CBCT EXAM --------------------------------------------------------------------------------------------------38 CEPH ACQUISITION ---------------------------------------------------------------------------------------- 40 7.1 SELECTING THE EXAM TYPE --------------------------------------------------------------------------------------------------------40 7.2 PATIENT POSITIONING ---------------------------------------------------------------------------------------------------------------40 7.3 EXECUTION OF THE CEPH EXAM --------------------------------------------------------------------------------------------------42 USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...
  • Page 5 11.17.1 RECOMMENDED SEPARATION DISTANCES ------------------------------------------------------------------------------------------------ 82 11.17.2 ELECTROMAGNETIC EMISSIONS -------------------------------------------------------------------------------------------------------------- 82 11.17.3 ELECTROMAGNETIC IMMUNITY --------------------------------------------------------------------------------------------------------------- 83 11.17.4 ELECTROMAGNETIC IMMUNITY, HANDHELD RADIOFREQUENCY EQUIPMENT --------------------------------------------- 84 WARNINGS ---------------------------------------------------------------------------------------------------- 85 INTERACTIONS CONTRAINDICATIONS PROHIBITIONS ------------------------------------ 88 USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...

  • Page 6: Introduction

    The training and preparation of personnel must be included in the tasks of the responsible organization. Before using the X-MIND trium, the operator must read and understand all the instructions provided in the manual in order to obtain the highest performance and ensure the safety of patients, of operators, of the medical device and the environment.
  • Page 7 • Uses other than those specified in this manual. • Use of accessories (temple rest, chin rest, bites, etc.) other than those supplied by ACTEON Imaging, • Use of hygienic protections different from class I Medical Device Directive 93/42/EEC and subsequent amendments or not compliant with ISO 10993 series of standards.

  • Page 8: Identification Tags

    Hounsfield Unit. Standard reference scale used to describe radiodensity in systems. Acteon imaging Suite software that manages all the functional aspects of the X-MIND trium system, including: patient database, patient acquisition, calibrations, quality tests, maintenance, display that allows the operator to make the diagnosis and treatment planning.
  • Page 9 FRANKFURT LASER APERTURE Please see section 11.11 for more details X-MIND trium is a class 3R laser product. Avoid direct eye exposure to laser radiation. Viewing the laser output with telescopic optical instruments (for example, telescopes and binoculars) may pose an eye...
  • Page 10 E N G L I S H REMOVABLE DETECTOR LABEL 3D DETECTOR LABEL CEPH ARM LABEL ETL MARKING UDI LABEL USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...

  • Page 11: Position Of The Identification Labels

    E N G L I S H 1.4 POSITION OF THE IDENTIFICATION LABELS USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...

  • Page 12: Standardized Symbols

    This symbol reminds that is mandatory to carefully read the whole documentation and manuals provided with the medical device before to perform whatever operation. Electronic instructions for use symbol for medical devices, according to EN ISO 15223-1: 2016 USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...

  • Page 13: Description

    Communication with the medical device occurs by means of Ethernet protocol. 2.2 X-MIND TRIUM REMOTE CONTROL The X-MIND trium remote control must be located in a safe place protected against radiations, in compliance with the local standards in force concerning ionising radiation protection.

  • Page 14: X-Mind Trium Medical Device

    X-MIND trium Light The X-MIND trium Light is an indicator light that warns that X-ray emission is in progress. It indicates no entry into the room when the red light is on; it also has a triangular danger sign that warns of X-ray hazards.
  • Page 15 Group. Overview of the medical device: Cephalometric extension: The Cephalometric version of X-MIND trium medical device consists of the parts listed above and of the following additional parts: 11. CEPH arm extension. Can be positioned both on the right or left side of the vertical column.

  • Page 16: X-Mind Trium Configurations

    • CBCT exams can be carried out at different FOV dimensions as specified in the technical data appendix. 2.5 EXAMS In its different configurations X-MIND trium equipment carries out the following exams: Panoramic group The panoramic group includes all the 2D radiographs of the jaws, dentition, temporomandibular joints and maxillary sinuses.
  • Page 17 For all examination groups, the operator set the predefined loading factors, in terms of X-ray anodic current and X-ray tube voltage, by selecting the patient type between the following options: · MAN - small USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...

  • Page 18: Control Panels

    U-arm position to align the patient to X-ray beam and set the “ready to X-ray” status. Some keys are duplicated on the CEPH control panel, for use during patient positioning for CEPH exams. Equipment control panel CEPH control panel USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...

  • Page 19: Keys Description

    These keys are also present on CEPH control panel and have the same functionality. Bite block up or down Press the following keys: or DOWN By single pressure of these keys the selected part of the equipment is moved by 1 mm. USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...

  • Page 20: Light Indicators

    2.9 X-MIND TRIUM REMOTE CONTROL The X-MIND trium remote control must be kept in a safe place protected against radiations, in compliance with local standards in force concerning radiation protection. The X-MIND trium remote control allows the operator to activate or deactivate X-ray emissions from the control room.

  • Page 21: Emergency Switches

    Remote emergency switch 1= Remote emergency switch The Remote emergency switch is located on the X-MIND trium remote control. How to use the emergency switches In case of an emergency, stop any movement of the device and X-ray emission by pressing either the patient emergency switch or the remote emergency switch.

  • Page 22: X-Ray Exposure Switch

    The head support in CEPH arm positions and immobilises the patient before the scan. It is equipped with a couple of ear rests and a nose support to ensure maximum stability. USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...

  • Page 23: Accessories

    The bite block and chin rest assembly must be used for immobilizing the patient in panoramic exams except in case of edentulous patients; in addition, it can be used in CBCT scans when an improved 3D reconstruction of the dental crown surface is required. USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...
  • Page 24 The calibration procedure consists of a scan of the calibration phantom and the estimation of a set of parameters that des- cribe the configuration of the system. Quality phantom support for Germany This accessory is intended to position the QUART DVT test phantoms for QA/QC of CBCT functionality for X-MIND trium installed in Germany. Self standing base This accessory allows to install X-Mind trium where the wall cannot adequately support trium load.

  • Page 25: Switching On / Off The System

    • Select the language among the available ones, type in the User Name and Password and press OK. • X-MIND trium automatically loads the software and connects the workstation with the medical device. • Check connection status between device and workstation referring to the icon shown on the display of the control panel...

  • Page 26: Switching Off

    • Switch OFF the medical device by setting the main switch to off. The main switch is located on the lower part of the patient support. CAUTION : Always switch the system off during long period of inactivity like night time, weekends and holidays. USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...

  • Page 27: Pre Acquisition

    E N G L I S H PRE ACQUISITION This chapter describes the procedure to acquire images of a new patient using X-MIND trium. The instructions below describe how to prepare the system, position the patient and scan the anatomical volume.

  • Page 28: Positioning The Patient For Pan/Cbct Exams

    • Use the COLUMN UP and DOWN buttons to adjust the height of the mobile column and adapt the head support to the patient’s stance (sitting or standing). USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...
  • Page 29 • If the patient is fitted with a lead-lined apron for radiation protection, make sure that his neck is not covered, because this will cause unexposed areas in the radiograph. The X-MIND trium is equipped with five laser beams that help the operator position the patient in the FOV. • Ask the patient to close his/her eyes.

  • Page 30: Pan Acquisition

    “US” is not enabled The values of loading factors are indicated below : Child Woman Man small Woman Woman Man large medium small medium medium large PANORAMIC SINUS USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...

  • Page 31: Patient Positioning

    • Ask the patient to bite the bite block (or place chin on the chin rest for edentulous patients). • Turn on positioning LASERs. X-MIND trium is a class 3R laser product. Avoid direct eye exposure to laser radiation. Viewing the laser output with telescopic optical instruments (for example, telescopes and binoculars) may pose an eye...
  • Page 32 TMJ exams. Move the U-arm by pressing the dedicated keys to adjust the anterior or posterior directions. for PANORAMIC and SINUS exams for TMJ exams USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...

  • Page 33: Execution Of The Pan Exam

    • Go out from the room to start exam; do not forget to observe the applicable radiation safety procedure. • Start the PAN exam by pressing the X-ray emission switch on the X-MIND trium remote control. During this stage, the device emits X-rays;...

  • Page 34: Cbct Acquisition

    40 mm x 40 mm investigating localised dental (diameter x height) problems and planning single Resolution: standard implants. medium, high, Reconstruction 400x400x400 grid (default): Voxel size 0.1 mm (default): USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...
  • Page 35 Nose This examination is used for Reconstruction 693x693x500 diagnostic investigations of upper grid (default): airways and paranasal sinuses. Voxel size 0.15 mm (default): USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...
  • Page 36 Bear in mind that a broader FOV is obtained by a wider X-ray beam which encloses a larger anatomical region but also implies an increase in radiation dose absorbed by the patient. USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...

  • Page 37: Patient Positioning

    E N G L I S H 6.2 PATIENT POSITIONING X-MIND trium is a class 3R laser product. Avoid direct eye exposure to laser radiation. Viewing the laser output with telescopic optical instruments (for example, telescopes and binoculars) may pose an eye...

  • Page 38: Execution Of The Cbct Exam

    • Go out from the room to start exam; do not forget to observe the applicable radiation safety procedure. • Start the CBCT scan or acquire a scout view of the patient by pressing the X-ray emission switch on the X-MIND trium remote control.
  • Page 39 Monitor the patient throughout the entire exposure. In the event of an emergency, release the X-ray exposure switch to stop the U-Arm rotation and X-ray emission. In the event that the U-Arm rotation and/or X-ray emission do not stop, press the remote emergency switch. USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...

  • Page 40: Ceph Acquisition

    • Turn nose support in vertical position and move it vertically and horizontally until the extreme side of the support is on the nose root; USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...
  • Page 41 + Ask the patient to place its hand on the carpus support, verifying that it is completely included in the rectangular area drawn on the support (a). Proceed with the execution of the exam. USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...

  • Page 42: Execution Of The Ceph Exam

    • Go out from the room to start exam; do not forget to observe the applicable radiation safety procedure. • Start the CEPH exam by pressing the X-ray emission switch on the X-MIND trium remote control. During this stage, the device emits X-rays;...

  • Page 43: User Manual• X-Mind Trium • (13) • 03/2018 • Ntr0En010M

    In case of an error, a code will be shown on the display, and a red light turns on warning the operator about malfunctioning. For error details please refer to the “TROUBLESHOOTING” chapter. USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...

  • Page 44: Maintenance, Cleaning And Disposal

    Repairs and replacements of any component must be carried out solely by authorized and highly qualified personnel and only using genuine spare parts supplied by de Götzen® S.r.l. - ACTEON Group. 9.2 CLEANING Clean the external surface using a damp cloth with non-corrosive and non oil-based detergent; disinfect the external surface using a non-aggressive medical detergent.

  • Page 45: Troubleshooting

    General reset Manually reset the device; if the error persists, turn the X-MIND trium off from the main switch and turn it on again after 30 seconds. If the error still persists leaving X-MIND trium on, restart the AIS; if the problem is still not solved, restart the Workstation.

  • Page 46: Trium Errors

    If error remains technical service is required. "Y_AXIS_ERR_RES_RAMP Reset error from AIS software on workstation; Unexpected FSM condition during if error remains restart X-MIND trium and workstation; Y-axis reset" USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...
  • Page 47 X-MIND trium and workstation; Y-axis position adjustment" "B_AXIS_ERR_RUN_PTPT Reset error from AIS software on workstation; Unexpected FSM condition during if error remains restart X-MIND trium and workstation; B-axis position adjustment" USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...
  • Page 48 Reset error from AIS software on workstation; Inverter board error: if error remains restart X-MIND trium and workstation; GENERAL STATE ERROR, bit 9 - If error remains technical service is required. OVERVOLTAGE ON NEGATIVE STAGE" USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...
  • Page 49 Reset error from AIS software on workstation; Inverter board error: if error remains restart X-MIND trium and workstation; GENERAL STATE ERROR, bit 23 - HEAT If error remains technical service is required. SINK OVER TEMPERATURE" USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...
  • Page 50 Reset error from AIS software on workstation; Inverter board error: if error remains restart X-MIND trium and workstation; GENERAL STATE ERROR, bit 37 - If error remains technical service is required. OVERLOAD ON POSITIVE HV STAGE" USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...
  • Page 51 Reset error from AIS software on workstation; Hanning board error code 9 - Inverter if error remains restart X-MIND trium and workstation; over-current / peak current error" If error remains technical service is required. USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...
  • Page 52 The equipment can be operated, but the occurrence of the achievement of mechanical limit this error means that the column potentiometer is out of switches" calibration; technical service is required: USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...
  • Page 53 If error remains technical service is required. "VERT_SUP_PT_PT_GOTO The point-to-point positioning of Reset error from AIS software on workstation; vertical-sup axis of primary collimator if error remains restart X-MIND trium and workstation; is failed" USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...
  • Page 54 "XRAYS_EXAM_DO_BREAK Wait the full exam procedure is completed before releasing WARNING: operator has intentionally XRay button: message onworkstation “exposure button can stopped the Xray emission releasing be released” XRay button" USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...

  • Page 55: Annexes

    CEI OPX/105 Nominal High Voltage 60 – 90 kV Anode Material Tungsten Anode thermal capacity 30 kJ Focal spot size (IEC 60336) 0.5 mm x 0.5 mm Target angle 5° USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...
  • Page 56 Leakage radiation < 0.88 mGy/h @ 1 m X-ray voltage accuracy ± 10% X-ray current accuracy ± 20% Radiation linearity ± 20% X-ray emission time accuracy ± (10% + 1 ms) USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...

  • Page 57: Degree Of Protection Provided By Enclosures

    IEC 60601-2-63 Par. 203.6.3.2.101 – 21 CFR 1020.31 (b) IEC 60601-2-63 Par. 203.9 – 21 CFR 1020.31 (f) 11.4 DEGREE OF PROTECTION PROVIDED BY ENCLOSURES According to the standard IEC 60529, the degree of protection is IP20 USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...

  • Page 58: Device Mechanical Data

    Direct deposition CsI Manufacturer Hamamatsu Photonics K.K. PAN: FPD C10500D-43 Model CEPH: FPD C10502D-43G Pixel size 100 µm PAN: 148 mm x 6 mm Active area CEPH: 223,2 mm x 6 mm USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...

  • Page 59: Scanning Parameters - Pan/Ceph

    12 s – 30 s Rotation 360° 6s (Standard quality) X-ray real exposure time 7.2s (Medium quality) 9s (High quality) Tube voltage 80 - 90 kVp Anodic current 4 – 10 mA USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...

  • Page 60: Laser

    Screen resolution: minimum height 1024 and width 1600, it is suggested to use higher resolutions for optimal planning (full HD: 1920 x 1080) O/S: Windows 7 (64 bit), Windows 10 (64 bit). MAC OS BASED HARDWARE USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...

  • Page 61: Intended Environment

    • Temperature: 0 to 50°C • Relative humidity: See clinical environment conditions • Atmospheric pressure: 500 to 1060 hPa Warehousing environment conditions: • See Transportation environment conditions 11.14 DIMENSIONS OF THE UNIT PAN/CBCT USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...
  • Page 62 E N G L I S H CEPH WITH SELF STANDING USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...

  • Page 63: List Of International Standards And Directives

    11.16 DOSIMETRIC INDICATIONS The following tables provides dosimetric indications related to the execution of radiographic exams by the X-MIND trium. The radiation dose is reported in terms of Dose Area Product (DAP), which takes into account the size of the X-ray beam and its intensity, providing a thorough dose index;...
  • Page 64 E N G L I S H DAP values for PANORAMIC exams Exposure 13,5 7,28 4,98 4,24 12,38 7,16 10,74 7,16 10,74 14,34 6,94 Time [kV] [mA] [mGycm2] USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...
  • Page 65 E N G L I S H Exposure 13,5 7,28 4,98 4,24 12,38 7,16 10,74 7,16 10,74 14,34 6,94 Time [kV] [mA] [mGycm2] USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...
  • Page 66 E N G L I S H Exposure 13,5 7,28 4,98 4,24 12,38 7,16 10,74 7,16 10,74 14,34 6,94 Time [kV] [mA] [mGycm2] USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...
  • Page 67 [mA] [mGycm^2] [mGycm^2] [mGycm^2] SMALL 414,0 496,8 621,0 CHILD MEDIUM 552,0 662,5 828,1 LARGE 690,1 828,1 1035,1 SMALL 489,1 586,9 733,7 WOMAN MEDIUM 652,1 782,6 978,2 LARGE 815,2 978,2 1222,8 USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...
  • Page 68 E N G L I S H SMALL 564,2 677,0 846,3 MEDIUM 752,2 902,7 1128,4 LARGE 940,3 1128,4 1410,4 USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...
  • Page 69 14,5 11,9 17,6 14,4 22,2 17,4 14,3 20,5 16,8 25,9 20,3 16,7 23,4 19,1 29,6 23,2 19,0 26,4 21,5 33,3 26,1 21,4 29,3 23,9 37,0 29,0 23,8 12,1 15,3 12,0 USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...
  • Page 70 24,2 19,6 31,6 24,3 19,9 27,7 22,5 36,1 27,8 22,7 31,1 25,3 40,6 31,3 25,6 34,6 28,1 45,2 34,8 28,4 14,2 11,5 18,6 14,3 11,7 17,7 14,4 23,3 17,9 14,6 USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...
  • Page 71 31,9 25,8 42,7 32,4 26,4 35,9 29,0 48,0 36,5 29,7 39,9 32,2 53,3 40,5 33,0 16,3 13,2 21,9 16,6 13,5 20,4 16,4 27,3 20,8 16,9 24,5 19,7 32,8 24,9 20,3 USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...
  • Page 72 40,7 32,7 55,3 41,7 33,8 45,2 36,3 61,5 46,3 37,6 18,4 14,8 25,1 18,9 15,3 23,0 18,5 31,4 23,6 19,2 27,6 22,2 37,7 28,4 23,0 32,2 25,9 44,0 33,1 26,9 USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...
  • Page 73 23,5 18,9 32,1 24,1 19,6 28,2 22,6 38,5 28,9 23,5 32,9 26,4 44,9 33,8 27,4 37,6 30,2 51,4 38,6 31,3 42,2 34,0 57,8 43,4 35,2 46,9 37,7 64,2 48,2 39,1 USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...

  • Page 74: Dosimetric Indications In Terms Of Ctdi (For Cbct Exams)

    11.16.2 DOSIMETRIC INDICATIONS IN TERMS OF CTDI (FOR CBCT EXAMS) The following tables provide dosimetric indications related to the execution of CBCT exams using X-MIND trium. The radiation dose is reported in terms of Computed Tomography Dose Index (CTDI), which represents the integral of dose profile along a line perpendicular to the tomographic plane divided by the product of the nominal tomographic section thickness and the number of tomograms produced in a single scan.
  • Page 75 43.2 3.79 1.33 Medium Medium 57.6 5.11 1.79 Large Medium 10.0 72.0 6.36 2.23 Small High 54.0 4.77 1.67 Medium High 72.0 6.36 2.23 Large High 10.0 90.0 7.93 2.78 USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...
  • Page 76 43.2 3.08 1.08 Medium Medium 57.6 4.21 1.47 Large Medium 10.0 72.0 5.29 1.85 Small High 54.0 3.96 1.38 Medium High 72.0 5.20 1.82 Large High 10.0 90.0 6.53 2.29 USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...
  • Page 77 43.2 2.59 1.51 Medium Medium 57.6 3.47 1.15 Large Medium 10.0 72.0 4.40 1.49 Small High 54.0 3.26 1.88 Medium High 72.0 4.36 0.77 Large High 10.0 90.0 5.41 1.03 USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...
  • Page 78 43.2 2.81 2.51 Medium Medium 57.6 3.64 3.24 Large Medium 10.0 72.0 4.53 4.04 Small High 54.0 3.39 3.02 Medium High 72.0 4.49 4.00 Large High 10.0 90.0 5.64 5.02 USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...
  • Page 79 43.2 1.97 1.75 Medium Medium 57.6 2.48 2.21 Large Medium 10.0 72.0 3.05 2.72 Small High 54.0 2.27 2.03 Medium High 72.0 2.80 2.50 Large High 10.0 90.0 3.82 3.41 USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...
  • Page 80 43.2 0.65 0.58 Medium Medium 57.6 0.82 0.73 Large Medium 10.0 72.0 1.13 1.01 Small High 54.0 0.58 0.51 Medium High 72.0 1.07 0.95 Large High 10.0 80.0 1.26 1.12 USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...
  • Page 81 The following tables report the standard deviation, respectively, for peripheral and central positions in the dosimetry phantom: STANDARD DEVIATION [mGy] 0.64 WOMAN 1.01 CHILD 0.73 STANDARD DEVIATION [mGy] 0.25 WOMAN 0.26 CHILD 0.47 USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...

  • Page 82: Electromagnetic Compatibility

    The use of accessories other than those specified or sold by ACTEON® Imaging as replacement parts, may increase the transmission or reduce the immunity of the medical device.

  • Page 83: Electromagnetic Immunity

    3 A/m typical level of standard mains for commercial or Test level hospital use. IEC 61000-4-8 Note: Ut is the AC mains voltage prior to the application of the test level. USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...

  • Page 84: Electromagnetic Immunity, Handheld Radiofrequency Equipment

    In the event of abnormal operation, additional measures may be required, such as redirecting or relocating the product. (b) Over the frequency range between 150 kHz and 80 MHz, the field strength must be below 10 USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M...

  • Page 85: Warnings

    CT dental scanners with respect to the FOV generated INFORMATION APPLICABLE TO ALL THE COUNTRIES WHERE THE DEVICE IS SOLD: ACTEON Imaging, upon request, provides Training and/or materials for training on the basis of the specific needs identified by RESPONSIBLE ORGANIZATION.
  • Page 86 The medical device has been designed to acquire digital radiography images and reconstruct tomographic images of the dental maxillofacial and otolaryngological regions. 12.8 ESSENTIAL PERFORMANCE ACTEON Imaging considered the essential performances, as stated in the applicable safety standard pertaining to the electrical medical device, in the Risk Management Process. 12.9 NORMAL USAGE CONDITIONS The normal usage conditions are as follows: •...
  • Page 87 IEC 64-8 standard with reference to premises used for medical purposes. 12.13 POSITIONING LASERS X-MIND trium is a class 3R laser product. Avoid direct eye exposure to laser radiation. Viewing the laser output with telescopic optical instruments (for example, telescopes and binoculars) may pose an eye...

  • Page 88: Interactions Contraindications Prohibitions

    The medical device was designed and developed with its accessories to guarantee maximum safety and performance. The use of accessories from another source could put you and your patients at risk and could damage your medical device. Do not try to connect accessories not provided by ACTEON Imaging to your ®...
  • Page 89 2460 de Götzen S.r.l • A company of ACTEON Group 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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