Acteon x-mind ac Operator's Manual
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Acteon x-mind ac Operator's Manual

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OPERATOR'S MANUAL
OPERATOR'S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F

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  • Page 1 OPERATOR’S MANUAL OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F...
  • Page 2 Via Roma, 45 21057 OLGIATE OLONA (VA) – ITALY Tel. +39 0331 376760 Fax +39 0331 376763 www.acteongroup.com For information and technical assistance, contact the manufacturer imaging.italysupport@acteongroup.com Page 2 of 55 OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F...
  • Page 3 WITHOUT PRIOR WRITTEN CONSENT BY de GÖTZEN® S.r.l. – ACTEON Group. THE MANUAL MUST ALWAYS BE KEPT NEAR THE MEDICAL DEVICE FOR FUTURE REFERENCE. de Götzen® S.r.l. – ACTEON Group SHALL NOT BE LIABLE FOR AN INCORRECT USE OF THE INFORMATION CONTAINED IN THIS MANUAL.

  • Page 4: Table Of Contents

    A4. DOSIMETRIC INDICATIONS ..........................47 ANNEX 5 ............................48 A5. ELECTROMAGNETIC COMPATIBILITY ........................48 ANNEX 6 ............................52 A6. DRAWINGS AND DIMENSIONS ...........................52 ANNEX 7 ............................54 A7. INSTALLATION ELECTRICAL SCHEME ........................54 Page 4 of 55 OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F...

  • Page 5: Control Panel

    SAVE IN OCCLUSAL MEMORY EXAM MAXILLARY LOWER TEETH BITE - WING EXAM DIGITAL X-RAY CONVENTIONAL X-RAY X-RAY OUPTUT SIGNAL PAUSE INDICATOR MANDIBULARY LOWER TEETH MALFUNCTION INDICATOR Page 5 of 55 OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F...

  • Page 6: Preliminary Information

    “x-mind ac” radiographic system. It is designed and manufactured by de Götzen® S.r.l. – ACTEON Group and is the result of many years of experience in the field of radiology and in the application of advanced electronics.

  • Page 7: Quality Determinants In X-Ray Intraoral Radiography

    It is mandatory to comply with these instructions every time the device is used. “x-mind ac” is compatible with all kind of X-ray detectors which have been designed and certified for dental intra-oral radiology; in detail, such a compatibility is ensured by the compliance of the “x-mind ac” device with the basic safety and essential performance requirements of the IEC 60601-2-65: 2012.

  • Page 8: Warranty Coditions

    WARNING It is full responsibility of the operator and RESPONSIBLE ORGANIZATIONS of the “x-mind ac” to check that any kind of X-ray detectors used with the “x-mind ac” are in compliance with the requirements stated by their specific regulations in force and to the specifications stated by their respective manufacturers.
  • Page 9 X-ray imaging of other body parts. Carefully follow the instructions of this manual to install, operate and maintain the “x-mind ac” radiographic system. In the event that local laws and standards are more restrictive than the manufacturer’s indications, the former supersede the latter.
  • Page 10 3. Reduction of the limits of individual dose and risks The “x-mind ac” is a medical device that generates X-rays; therefore, both the patients and the operator are exposed to risks due to ionizing radiation. The physician must assess the actual need for X-ray exposure.
  • Page 11 Adjustments or any kind of attempt of repairing or disassembling must only be performed by qualified and authorized service personnel. The “x-mind ac” must not be used in environments or close to environments subjected to mechanical vibrations or mechanical shocks.
  • Page 12 SYSTEM MODIFICATIONS OR UPGRADES Modifications or upgrades of the system can be carried out only if advised by de Götzen® S.r.l. – ACTEON Group and performed by authorized and qualified personnel, using ONLY genuine original spare parts of de Götzen® S.r.l. – ACTEON Group.

  • Page 13: Radiographic System

    ENGLISH RADIOGRAPHIC SYSTEM 2.1. RADIOGRAPHIC SYSTEM The “x-mind ac” radiographic system guarantees the maximum safety both for the operator and the patient. It is built in compliance with the following European Directives: ►93/42/EEC and subsequent amendments MEDICAL DEVICES ►EURATOM 96/29 IONISING RADIATIONS The following protective measures were adopted in the design and construction of the unit: - protection against the risk of electric injuries, ensured by a grounded protection conductor;...

  • Page 14: System Components

    It is made of light alloy with an ABS coating. 4. x-mind ac TUBEHEAD The intra-oral tubehead “x-mind ac” is a monoblock type and its light alloy housing contains an airtight compartment. The high voltage transformer, the X-ray tube and the expansion chamber are submerged in highly dielectric insulating oil inside a light alloy container.

  • Page 15: Identification Tags

    Via Roma 45 - 21057 Olgiate Olona (VA) - ITALY 70kVp 8mA Total filtration: 2,3mm Al / 70kV 0.7mm Rated line voltage: 220V ~ 50/60Hz Class I X-ray tube: TOSHIBA DG-073B-AC tube: Model 115 V Page 15 of 55 OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F...
  • Page 16 Götzen S.r.l. Via Roma 45 - 21057 Olgiate Olona (VA) – ITALY Rated line voltage: 115V 50/60Hz Class I Absorbed power: 0,66kVA IP20 CONE GRADUATED SCALE Page 16 of 55 OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F...
  • Page 17 ATTENTION, REFER TO THE ATTACHED DOCUMENTS INSTRUCTIONS IN ELECTRONIC FORMAT REFER TO MANUAL’S INSTRUCTIONS WEEE (Waste Electrical and Electronic Equipment) SYMBOL, IN CONFORMITY WITH 2012/19/ CE DIRECTIVE AND EN 50419 STANDARD. Page 17 of 55 OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F...

  • Page 18: Configuration

    ENGLISH CONFIGURATION 3.1. CONFIGURATION The “x-mind ac” radiographic system is provided in the “standard mode” configuration. On the control panel the LED relevant to the following exposure parameters will light up: No. of the selected tubehead LED 1 supplied cone LED 8”...
  • Page 19 ►Type of tubehead (AC/DC) ►N° control button ►Type of cone (8” /12”) change the dip-switch position, inside the timer THIS OPERATION MUST BE CARRIED OUT BY THE INSTALLER ONLY Page 19 of 55 OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F...

  • Page 20: Instructions For Use

    If the timer remains inactive for a few minutes, it switches to the stand-by mode. Press any key on the control panel to restore it to the operative mode. Page 20 of 55 OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F...
  • Page 21 It is not possible to change the selection: an ac device has to be used only in combination with an ac tubehead Page 21 of 55 OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F...
  • Page 22 CONVENTIONAL TECHNIQUE (FILM) The LED of the desired speed film should be turned on LED D ON radiographic system is set for use with D speed film Page 22 of 55 OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F...
  • Page 23 STEP 8 : check the selected radiographic technique PERIAPICAL EXAM The LED of the selected teeth should be turned on to change the selection press the key relative to the desired tooth Page 23 of 55 OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F...
  • Page 24 6° - CHECK ON THE DISPLAY THE SELECTED TIME Before proceeding with the exposure, check on the display the selected time to change the selection press the following keys Page 24 of 55 OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F...
  • Page 25 A NEW EXPOSURE WILL BE POSSIBLE AFTER THE GREEN LED HAS TURNED OFF REPEAT THE OPERATIVE SEQUENCE FROM POINT 2 TO POINT 7 TO MAKE A NEW EXPOSURE Page 25 of 55 OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F...

  • Page 26: Exposure Values

    Before performing an intraoral radiograph by any Digital X-ray sensor (CMOS or CCD) or Phosphor Plates (PSP), the operator must imperatively verify and eventually adjust the pre-programmed exposure time setting of the “x-mind ac” using the instructions contained in the accompa- nying document of the sensor.
  • Page 27 EXPOSURE TIMES (sec) MAXILLA FILM MANDIBLE MAXILLA FILM MANDIBLE MAXILLA FILM MANDIBLE CHILD PROGRAMMED EXPOSURE TIMES (sec) MAXILLA FILM MANDIBLE MAXILLA FILM MANDIBLE MAXILLA FILM MANDIBLE Page 27 of 55 OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F...
  • Page 28 ENGLISH DIGITAL RADIOGRAPHIC TECHNIQUE (SENSOR) ADULT PROGRAMMED EXPOSURE TIMES (sec) MAXILLA MANDIBLE CHILD PROGRAMMED EXPOSURE TIMES (sec) MAXILLA MANDIBLE Page 28 of 55 OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F...
  • Page 29 MANDIBLE MAXILLA FILM NON DISPONIBILE NOT AVAILABLE MANDIBLE CHILD PROGRAMMED EXPOSURE TIMES (sec) MAXILLA FILM MANDIBLE MAXILLA FILM MANDIBLE MAXILLA FILM NON DISPONIBILE NOT AVAILABLE MANDIBLE Page 29 of 55 OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F...
  • Page 30 ENGLISH DIGITAL RADIOGRAPHIC TECHNIQUE (SENSOR) ADULT PROGRAMMED EXPOSURE TIMES (sec) MAXILLA MANDIBLE CHILD PROGRAMMED EXPOSURE TIMES (sec) MAXILLA MANDIBLE Page 30 of 55 OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F...

  • Page 31: Programming Default Exposure Values

    PROGRAMMING DEFAULT EXPO- SURE VALUES 6.1. PROGRAMMING DEFAULT EXPOSURE VALUES WARNING The 17 programmed exposure times cannot be modified in the “x-mind ac” radiographic sys- tem. Meanwhile it is possible to customize the default exposure values. WARNING After customizing, the “Chart of default exposure values” (refer to Chapter 5) are not valid any more.
  • Page 32 CUSTOMISED EXPOSURE VALUES THE RANGE OF EXPOSURE FIELD HAS BEEN REDUCED BY TWO STEPS ADULT PROGRAMMED EXPOSURE TIMES (sec) MAXILLA FILM MANDIBLE MAXILLA FILM MANDIBLE MAXILLA FILM MANDIBLE Page 32 of 55 OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F...

  • Page 33: Restoring Original Values

    3 . “OFF” appears on the display 4. Release the key 5. Press again the key ON 6 . “ON” appears on the display 7 . Turn off and on the timer Page 33 of 55 OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F...

  • Page 34: Diagnostic

    ENGLISH DIAGNOSTIC 7.1. DIAGNOSTIC With “x-mind ac” radiographic system it is possible to set and visualise certain functional parameters. To visualise them proceed as follows: 1. press simultaneously and keep pressed the keys (17) MAXILLA MOLAR (47) MANDIBULARY MOLAR 2. press the key associated to the parameter one wishes to visualise...

  • Page 35: Chapter 8

    CALL THE “ASSISTANCE SERVICE” THE CONTROL BUTTON DOES NOT CORRESPOND CALL THE “ASSISTANCE SERVICE” TO THE SELECTED TUBEHEAD ALL FUNCTIONS ARE DISABLED MAJOR ERROR CALL THE “ASSISTANCE SERVICE” Page 35 of 55 OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F...

  • Page 36: Verification Of The Exposure Factors

    = 31cm (12”) (SSD) or 20cm (8”) (SSD). SET TECHNICAL FACTORS Vn ± 10% NOMINAL VOLTAGE MAXIMUM VOLTAGE DROP 70 kV NOMINAL HIGH VOLTAGE 8 mA NOMINAL CURRENT SET EXPOSURE TIME Page 36 of 55 OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F...
  • Page 37 70 kV NOMINAL HIGH VOLTAGE 8 mA NOMINAL CURRENT 3,2 s SET EXPOSURE TIME The exposure time measured is 3,2s ±5% or ±20 ms, whichever is larger. Page 37 of 55 OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F...

  • Page 38: Suggested Maintenance

    • Do not use UV systems to disinfect the equipment, as exposed parts of the device can turn yellow or discolour. • To avoid any potential hazard or danger to operators and patients, contact your authorized Acteon Technical Representative immediately if you experience any unusual operation, mechanical issues, or equipment malfunction.
  • Page 39 • The RESPONSIBLE ORGANIZATION must always carry out routine maintenance on a daily basis to ensure optimal device performance. These checks must be performed to complete the installation of the “x-mind ac”X-ray System and as part of the recommended maintenance as indi- cated in the accompanying documents.

  • Page 40: Repair

    Contact your supplier before disposing of this product. CAUTION To avoid any risk of environmental contamination, do not dispose the device and its accessories together with the domestic waste. Page 40 of 55 OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F...

  • Page 41: Annex 1

    PLEASE NOTE The measurements criteria are based on the requirements stated by the applicable standards listed in the annex A.3 of this manual. Page 41 of 55 OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F...
  • Page 42 X-ray TUBE X-ray tube model TOSHIBA DG-073-AC Focal spot size (IEC 336) 0,7 mm Anode angle 20° Anod material tungsten Heating/cooling curves of the TOSHIBA DG-073B-AC Page 42 of 55 OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F...
  • Page 43 MECHANICAL DATA 19,5 kg (wall mounting) Total weight 50 kg (mobile version) Weight of the tubehead 5,5 kg Mechanical configuration Wall mounting, top and bottom / Mobile Page 43 of 55 OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F...
  • Page 44 31 cm (12’’) rectangular cone 31 cm (12’’) short cone ≤ 60 mm X-ray beam dimension long cone ≤ 60 mm rectangular cone 44x35 mm Page 44 of 55 OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F...

  • Page 45: Annex 2

    “x-mind ac” is for INDOOR USE ONLY. If the “x-mind ac” has been stored at a temperature below +10°C (+50° F) for more than a few hours, enough time must be allowed for the device to reach the room temperature before reconnecting it to the mains voltage and applying power.

  • Page 46: Annex 3

    ANNEX 3 A3. LIST OF INTERNATIONAL STANDARDS AND DIRECTIVES “x-mind ac”: X-ray equipment for dental intraoral radiography, is in compliance with the following: • MDD 93/42 EEC and subsequent amendments In compliance with the classification indicated in the Medical Device Directive 93/42/EEC, Annex IX, article 10: “Active devices intended to emit ionizing radiation and intended for diagnostic radiology”, the system is classified...

  • Page 47: Annex 4

    0,63 43,777 107,077 27,234 55,590 135,971 34,582 69,487 169,964 43,228 1,25 86,859 212,455 54,035 111,179 271,942 69,165 138,974 339,928 86,456 173,718 424,910 108,070 222,358 543,885 138,329 Page 47 of 55 OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F...

  • Page 48: Annex 5

    Guidance and manufacturer’s declaration – electromagnetic emissions “x-mind ac” is intended to be used in the electromagnetic environment specified below. The customer or the operator of “x-mind ac” must ensure that the device is used in this type of environment.
  • Page 49 ENGLISH Guidance and manufacturer’s declaration – electromagnetic immunity “x-mind ac” is intended to be used in the electromagnetic environment specified below. The customer or “x-mind ac” operator must ensure that the device is used in this type of environment. Electromagnetic...
  • Page 50 ENGLISH Guidance and manufacturer’s declaration – electromagnetic immunity “x-mind ac” is intended to be used in the electromagnetic environment specified below. The customer or “x-mind ac” operator must ensure that the device is used in this type of environment. CEI EN 60601...
  • Page 51 These devices are intended to be used in environments where radiated RF interference is controlled. The customer or “x-mind ac” operator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and “x-mind ac”, as indicated below, according to the maximum output power of the communication equipment.

  • Page 52: Annex 6

    WALL INSTALLATION Lateral view (rest position) Bottom mount 40 cm (16’’) bracket 63 cm 80 cm (31’’) bracket 104 cm 110 cm (43’’) bracket 132 cm Page 52 of 55 OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F...
  • Page 53 Manual. MOBILE INSTALLATION “x-mind ac” exists also in the mobile version and it is sustained by the stand shown in the following figure: For details, refer to the Mobile Unit Technical Note, supplied with this structure. Page 53 of 55...

  • Page 54: Annex 7

    ENGLISH ANNEX 7 A7. INSTALLATION ELECTRICAL SCHEME Page 54 of 55 OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F...
  • Page 55 ENGLISH de Götzen S.r.l • A company of ACTEON Group Via Roma 45 • 21057 OLIGATE OLONA (VARESE) • ITALY Tel +39 0331 376 760 • Fax +39 0331 376 763 E-Mail: imaging.italysupport@acteongroup.com •www.acteongroup.com...

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