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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.satelec.com/documents www.satelec.com/documents Page 2 of 79 Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H...
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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 3 of 79 Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H...
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WITHOUT PRIOR WRITTEN CONSENT BY de GÖTZEN® S.R.L. - ACTEON Group THIS MANUAL MUST ALWAYS BE KEPT NEAR THE MEDICAL DEVICE FOR FUTURE REFERENCE. “de Götzen® S.r.l. - ACTEON Group” SHALL NOT BE HELD LIABLE FOR MISUSE OF THE INFORMATION PROVIDED BY THIS MANUAL.
1.1. PRELIMINARY INFORMATIONS Before starting with the use of the “X-MIND unity” x-ray system, it is mandatory to carefully read and follow the instructions contained herein in order to obtain the best performance and assure the safety of the patient, operator, device and the environment.
5.10. ENABLE ACE MODE (OPTIONAL SOPIX/SOPIX2 INSIDE INSTALLED) ............34 5.10.1. IMPORTANT NOTES ABOUT ACE TECHNOLOGY AND X-MIND UNITY ..............34 5.10.2. HOW TO USE THE X-MIND UNITY WITH SOPIX/SOPIX2 INSIDE & ACE TECHNOLOGY ........35 5.11. POSITIONING THE PATIENT ..........................40 5.12.
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A.2 INTENDED ENVIRONMENT ..........................65 A.3 DIMENSIONS OF THE UNIT ..........................66 A.4 LIST OF INTERNATIONAL STANDARDS AND DIRECTIVES ................71 A.5 DOSIMETRIC INDICATIONS ..........................72 A.6 EMC COMPATIBILITY ............................76 Page 7 of 79 Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H...
X-MIND unity with the basic safety and essential performance requirements of the IEC 60601-2-65:2012. The ACE feature is available only when X-MIND unity is used with Sopix/Sopix2 Inside sensor system. For details refer to section 5.10 ENABLE ACE MODE (Optional Sopix/Sopix2 Inside Installed).
WARNING It is full responsibility of the operator and RESPONSIBLE ORGANIZATIONS of the X-MIND unity to check that any kind of x-ray detectors used with the X-MIND unity are in compliance with the requirements stated by their specific regulations in force and to the specifications stated by their respective manufacturers.
• The system must be checked completely at least each 12 months by professionally qualified technicians according to the regulations in force. Use the manuals provided with the device X-MIND unity for reference. • In case of repair, please only use OEM spare partsfrom the manufacturer of the X-MIND unity Otherwise basic safety and essential performances of the device will be not guaranteed.
• Carefully follow the instructions in this manual to install, operate and maintain the X-MIND unity device. In the event that local laws and standards are more restrictive than the manufacturer’s indications, the former supersede the latter.
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(by means of specific internal connections and configurations) ONLY with the integrated use of the Sopix/Sopix2 Inside x-ray digital intraoral sensor. It is strictly forbidden to connect or forcing to connect to the X-MIND unity, under any circumstance, any other device than the Sopix/Sopix2 Inside sensor type manufactured by Sopro –...
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• X-MIND unity generates x-rays: Before using this x-ray system please refer to the regulation in force in your area concerning paediatric patients, pregnant women and anyone with health issues that contraindicate the use of x-rays. Investigate and make sure of this condi- tion before starting the exposure.
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The requirements on the Separation Device is defined in IEC 60601-1-1 and in IEC 60601-1, edition 3, clause 16. • Based on the IEC 60601-1, the installation of the X-MIND unity wall version is a permanent type (fixed). IT IS NOT ALLOWED TO connect the equipment to the main supply using a plug.
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CAUTION EMC COMPATIBILITY • EMC requirements must be considered, and the X-MIND unity must be installed and used accordingly with the specific EMC information provided in the accompanying documents. • The device complies with the EMC (Electromagnetic Compatibility) according to IEC 60601-1-2. Radio transmitting equipment, cellular phones etc.
Class IIb “EMC” CLASSIFICATION According to paragraph §4 of the EN 55011, this system is classified as: Group 1 - Class B Page 16 of 79 Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H...
4 - X-RAY SOURCE ASSEMBLY (TUBEHEAD) The tubehead of the X-MIND unity contains the x-ray tube, the high voltage board and the high frequency generator. The high voltage board, the x-ray tube and the expansion chamber are submerged in a sealed alu- minum chamber containing highly dielectric insulating oil.
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E N G L I S H 5 - SENSOR AND SENSOR HOLDER (OPTIONAL, SOLD SEPARATELY) The X-MIND unity comes already prepared to be coupled as a separate installation performed by authorized technicians on the field), with the optional Sopix/Sopix2 Inside intraoral x-ray digital sensors (manufactured and sold by SOPRO - Acteon Group), which are equipped with the ACE technology.
The identification tags on the tube head, timer and cone indicate the model number, serial number, the manu- facturing date and the symbols of the main technical characteristics. Labels for Europe: Labels for USA: Page 19 of 79 Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H...
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REGARDING MEDICAL DEVICES This symbol remind that is mandatory read carefully the whole documentation and manuals provided with the medical device before perform whatever operation. Page 21 of 79 Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H...
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In the event the line fuse needs replacement you must observe all ratings and specifications declared by de Götzen® S.r.l. Call the technical support service for assistance as shown on pages 3 and 4 of this manual. Page 22 of 79 Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H...
2. INFORMATION DISPLAY 3. LOADING FACTORS AND RADIOGRAPHIC TECHNIQUE BUTTONS 4. FUNCTIONAL AND EXPOSURE TIME BUTTONS 5. TYPE OF PATIENT 6. TYPE OF EXAM Page 23 of 79 Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H...
The SSD distance depends on the type of beam limiting device installed. Make sure you have the correct type of cone installed according to the values and symbols explained in the accompanying documents and indicated on the display Page 24 of 79 Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H...
In this case it is possible to reset the error pushing the “memo” key or turning the timer off and then turn it back on again. If it is not possible to clear the error code call your local Acteon customer service as shown on pgs 3 & 4 of this manual.
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Before taking an x-ray exposure, always check that the parameters selected and displayed on the control panel (see the following steps below) are suitable for the x-ray examination being performed. Page 27 of 79 Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H...
Dig : Digital X-Ray Sensor PSP : Phosphor plates When the integrated Sopix/Sopix2 Inside sensor is installed and properly connected you can run the X-MIND unity with the ACE system activated.² the “ACE” code inside the list of selected type of supported detector (F-d, F-e, F-g, F-f, DIG) is available only when a Sopix/Sopix2 Inside is installed and properly connected.
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Possible modifications of the parameters: - Number of exposure switches - Cone size (20cm - 8” / 30cm - 12”) - Cone type (Square / Round) Page 29 of 79 Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H...
The modification, installation and configuration of a different type of beam limiting device can be enabled or disabled only by authorized and trained service technician. Contact your authorized installer or the local Acteon Customer Service number indicated on page 3 & 4 of this manual for further informa- tion.
Alternately pressing this button switches from child to adult settings. PLEASE NOTE After the modification, the default exposure values will be automatically changed Page 31 of 79 Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H...
- ACE indicates that the x-ray system is set for use with the integrated Sopix/Sopix2 Inside sensor system and with the ACE system activated from the X-MIND unity side (refer to specific chapter 5.10 for more information - Digit indicates that the x-ray system is set for use with external digital x-ray sensors...
The DAP values [mGy*cm2] relevant to the combination of the technique factors and settings selected for the exposure, can be checked by simultaneously pressing the following keys shown belowon the x-ray control unit keyboard of the X-MIND unity. The DAP value will be shownd on the display instead of the exposure time.
PLEASE NOTE The following parameters are sent to the Sopro Imaging software (developed by Sopro-Acteon Group) after the x-ray exposure if the ACE op- tion is activated and these parameters will be seen in the image properties. (Always refer to the Sopro software and Sopro device manuals)
5.10.2. HOW TO USE THE X-MIND UNITY WITH SOPIX/SOPIX2 INSIDE & ACE TECHNOLOGY CAUTION The operator must always verify communication between Sopix/Sopix² Inside and X-Mind unity by making sure the «ACE» logo on the control unit displays is illuminatedthe “ACE” logo on the control unit display, before each acquisition.
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PLEASE NOTE On the X-mind unity timer, the “ACE” logo appears in the list of the different types of X-Ray detector selections (F-d, F-e, F-g, F-f, DIG, PSP) only when a Sopix/Sopix2 Inside is installed, properly connected, and armed to acquire an image.
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- For more exposures -> disconnect Sopix/Sopix2 Inside USB cable or disarm it on SOPRO Ima- ging. D - ONLY Other manufacturers exter- External sensor is armed by its own software. Use the X-MIND unity as you would in normal nal sensors (NO Sopix/Sopix² Inside) digital procedure.
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E N G L I S H Combination B Combination C Page 38 of 79 Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H...
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Please only use the Sopix/Sopix2 Inside sensor when the ACE icon is illuminated on the X-Mind unity display. In case accidentally is exposed the external sensor to prevent accidental radation exposure to the patient or office staff while the ACE mode...
It is furthermore mandatory to carefully follow the operating instructions and take observe all safety measures according to the respective manufacturers of the x-ray detectors (FILM/X-RAY DIGITAL SENSORS/PSP, etc.), used by the operator. Page 40 of 79 Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H...
A bisector is a plane or line that divides a line or angle into two equal portions. Page 41 of 79 Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H...
CAUTION - WARNING Whenusing the X-MIND unity together with the integrated Sopix/Sopix² Inside x-ray digital sensor, be extremely certain that the complete sensor equipment and its holder are properly installed and safely connected to the X-Mind unity. The Sopix/Sopix² Inside must always be well maintained and properly functional.
Always maintain audio and visual contact with the patient and unit during the x-ray exposure: the operator is required to monitor the patient and the X-Mind unity parameters throughout the entire duration of the x-ray examination. Page 43 of 79...
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1s of exposure) A NEW EXPOSURE WILL BE POSSIBLE AFTER THE YELLOW LED HAS TURNED OFF REPEAT THE OPERATIVE SEQUENCE ABOVE TO MAKE NEW EXPOSURE Page 44 of 79 Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H...
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It is mandatory to disable the control unit by turning the safety key to “0” and remove the key to avoid accidental exposures when not in use. CAUTION It is extremely important not to use a remote exposure switch other than the original part provided by de Götzen S.r.l. – Acteon Group for operating the X-MIND unity. Page 45 of 79...
FUNCTIONING OF THE X-MIND unity light By default setting, the X-MIND unity light (when installed) is ON (lit) when the X-MIND unity is in ARMED mode When the X-MIND unity goes in stand-by or is switched off, the X-MIND unity light will go out.
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Plug the power supply cable Perform the settings and the x-ray exposure as described in section 5 operating instruction Page 47 of 79 Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H...
Before performing an intraoral radiograph by any Digital X-ray sensor (CMOS or CCD) or Phosphor Plates (PSP), the operator must imperati- vely verify and eventually adjust the preprogrammed exposure time setting of the X-MIND Unity along with the instructions in the accompa-...
0,32 s 0,125 s 0,2 s 0,1 s 0,16 s Molar 0,2 s 0,32 s 0,125 s 0,2 s 0,1 s 0,16 s Page 49 of 79 Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H...
0,32 s 12 inches – 30 cm SSD FILM D FILM E FILM F 65 kV – 7mA Child Adult Child Adult Child Adult Page 50 of 79 Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H...
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0,2 s 0,16 s 0,2 s 0,32 s 0,4 s Occlusal Mandibular 0,16 s 0,2 s 0,16 s 0,2 s 0,32 s 0,4 s Page 51 of 79 Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H...
PLEASE NOTE The value and steps of the 21 programmed exposure times of the X-MIND unity (refer to chapter 3 ) cannot be modified in the X-MIND unity x-ray system, since their values are in conformity according to the regulation in force concerning x-ray intra-oral equipment. however the operator does have the abilityto customize the default exposure values.
To restore the unit to the factory default settings select “YES” and press the key to confirm and save the selection. Press the key to exit from the menu. Page 53 of 79 Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H...
After this procedure, the PAUSE led will start blinking. During this period all the functions of the equipment are inhibited. Please wait until the X-MIND unity completes the cooling time due to the tube calibration before resuming normal operation. Page 54 of 79...
Le graphique suivant comprend une liste de message d’erreur pouvant apparaître lors du fonctionnement du système radiographique X- MIND unity. The following chart gives a list of error messages that will appear should the X-MIND unity experience a malfunction. The error codes have the following format: •...
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E128 power board fail power board failure E129 wireless unit not connected wireless receiver board not connected E132 system error hardware error Page 56 of 79 Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H...
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For the errors that can’t be cleared by the reset button on the keypad, please contact your installer or your local Acteon customer service Page 57 of 79 Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H...
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 unity X-Ray System and as part of the recommended maintenance as indicated in the accompanying documents. Failure to perform these checks may result in an installation that does not comply with U.S.
CAUTION To prevent any risk of environmental contamination, do not dispose this product together with domestic waste. Page 59 of 79 Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H...
Dimensions of the area of the x-ray beam output according to the shape of the beam limiting device: Cylindrical Beam Limiting device Ø≤60 mm Rectangular Beam Limiting device 44x35 mm Page 60 of 79 Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H...
The measurements criteria are based on the requirements stated by the applicable standards listed in the annex A of this manual. Coefficient of Variation Page 61 of 79 Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H...
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E N G L I S H Heating and cooling curve of the X-Mind unity X-Ray source Assembly (X-Ray Tube Housing) X-RAY TUBE X-ray tube model TOSHIBA D-041 Focal Spot Size (IEC 336) 0,4 mm Anode Angle 12,5° Anode material...
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Firmware versions maybe periodically updated therefore the versions indicated in the chart above may be different from the versions instal- led on the unit. To know the firmware versions installed in your X-MIND unity please follow the instructions in the following chapter “ADVANCED SETTINGS” of the “X-MIND unity Installation and Maintenance manual”.
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Momentary Operation (<5s) WARNING NEVER CONNECT the X-Mind Unity to the mains without first checking the voltage setting as indicated on the labels. Incorrect voltage set- tings will cause irreversible damage to the X-Mind unity electronics. DEGREE OF PROTECTION PROVIDED BY ENCLOSURES...
• If the X-Mind Unity 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 .
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E N G L I S H FRONT VIEW (REST POSITION) - MOBILE no bracket 141cm (55”) Page 70 of 79 Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H...
E N G L I S H A.4 LIST OF INTERNATIONAL STANDARDS AND DIRECTIVES The X-MIND unity: 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 as:...
In the following tables the radiation exposure is indicated in terms of DAP [mGy cm2] for each setting of kV, beam limiting device length (SSD) and Beam Limiting Device type (circular or rectangular). These values are displayed by the X-MIND unity when the corresponding loading factors are selected.
Guidance and manufacturer’s declaration – electromagnetic emissions X-MIND unity is intended to be used in the electromagnetic environment specified below. The customer or the operator of X-MIND unity must ensure that the device is used in this type of environment.
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E N G L I S H Guidance and manufacturer's declaration – electromagnetic immunity X-MIND unity is intended to be used in the electromagnetic environment specified below. The customer or X-MIND unity operator must ensure that the device is used in this type of environment.
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E N G L I S H Guidance and manufacturer's declaration – electromagnetic immunity X-MIND unity is intended to be used in the electromagnetic environment specified below. The customer or X-MIND unity operator must ensure that the device is used in this type of environment.
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Recommended separation distances between portable and mobile RF communication equipment and X-MIND unity medical device These devices are intended to be used in environments where radiated RF interference is controlled. The customer or X-MIND unity operator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communi- cation equipment (transmitters) and X-MIND unity, as indicated below, according to the maximum output power of the communication equipment.
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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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