Acteon X-MIND unity User manual

OPERATOR’S MANUAL
Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H
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Language of the original document: ENGLISH
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Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H
MANUFACTURER
de Götzen®S.r.l. - a company of ACTEON Group
Via Roma, 45
21057 OLGIATE OLONA (VA) – ITALY
Tel. [phone]
Fax [phone]
www.acteongroup.com
For information and technical assistance, contact the manufacturer
[email protected]

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THE ELECTROMEDICAL EQUIPMENT DESCRIBED IN THIS MANUAL REFERS TO THE X-MIND
unity MEDICAL DEVICE.
“de Götzen® S.r.l. - ACTEON Group” RESERVES THE RIGHT TO MODIFY THE PRODUCT AND
ALL THE MANUALS WITHOUT PRIOR NOTICE.
IT IS PROHIBITED TO MODIFY, COPY, REPRODUCE, DISPLAY, SHARE, DISCLOSE AND PUBLISH
THIS MANUAL AND ALL OTHER DOCUMENTS REFERRING TO X-MIND unity IN ANY FORM
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.

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Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H
INTRODUCTION
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.
Always pay close attention to the messages when operating the system.
CAUTION
WARNING
PLEASE NOTE
PROHIBITION
LEGEND
CAUTION
The word CAUTION identies those occurrences which might compromise the operator’s personal safety or cause injuries to people.
!
WARNING
The word WARNING identies those occurrences which might compromise the x-ray system’s performance.
PLEASE NOTE
PLEASE NOTE serves to give special indications to facilitate maintenance or make important information clearer.
PROHIBITION
PROHIBITION The word prohibition identies those actions that must be avoided because they might compromise the operator’s personal
safety or cause injuries to people.
11

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1. CONTENTS
INTRODUCTION..........................................................................................................................5
1.1. PRELIMINARY INFORMATIONS............................................................................................................................5
1.2. INFORMATION FOR THE OPERATOR...................................................................................................................8
1.2.1. QUALITY DETERMINANTS IN X-RAY INTRAORAL RADIOGRAPHY.................................................................9
1.3. WARRANTY CONDITIONS.....................................................................................................................................9
1.4. TRANSPORT CONDITIONS..................................................................................................................................10
1.5. SAFETY WARNINGS..............................................................................................................................................11
X-RAY SYSTEM OVERVIEW........................................................................................................16
2.1. SYSTEM COMPONENTS.......................................................................................................................................17
2.2. IDENTIFICATION TAGS........................................................................................................................................19
CONTROL PANEL OVERVIEW ...................................................................................................23
3.1.STATUS LED ...........................................................................................................................................................24
3.2.INFORMATION DISPLAY ......................................................................................................................................24
3.3.SETTINGS...............................................................................................................................................................25
3.4.TYPE OF PATIENT..................................................................................................................................................25
3.5.TYPE OF EXAMS.....................................................................................................................................................25
OPERATING INSTRUCTIONS....................................................................................................26
CONFIGURATION AND TAKING AN X-RAY EXPOSURE..........................................................28
5.1.CHECK THE SELECTED TYPE OF CONE ...............................................................................................................30
5.2.CHECK THE SOURCE TO SKIN DISTANCE...........................................................................................................30
5.3. CHECK THE SELECTED X-RAY TUBE VOLTAGE ..................................................................................................31
5.4.CHECK THE SELECTED X-RAY TUBE CURRENT...................................................................................................31
5.5.CHECK THE SELECTED TYPE OF PATIENT...........................................................................................................31
5.6.CHECK THE SELECTED X-RAY DETECTOR SUPPORT (FILM/DIGITAL/PSP) ......................................................32
5.7.CHECK THE SELECTED EXAM TYPE .....................................................................................................................32
5.7.1. PERIAPICAL EXAM....................................................................................................................................................... 32
5.7.2. OCCLUSAL EXAM......................................................................................................................................................... 32
5.7.3. BITEWING EXAM ......................................................................................................................................................... 33
5.8.CHECK THE SELECTED IRRADIATION TIME........................................................................................................33
5.9.CHECK THE DOSE AREA PRODUCT VALUES.......................................................................................................33
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. POSITIONING FILM OR SENSOR .....................................................................................................................40
5.12.1. PARALLELING TECHNIQUE ...................................................................................................................................... 41
5.12.2. BISECTING ANGLE TECHNIQUE .............................................................................................................................. 41
5.13. POSITIONING THE X-RAY GENERATOR AND COLLIMATOR (BEAM LIMITING DEVICE).............................42
5.13.1. SUGGESTED INCLINATION ANGLES ....................................................................................................................... 43
5.14. MAKE THE EXPOSURE .......................................................................................................................................43
5.15. TRANSPORT AND POSITIONING OF THE MOBILE STAND............................................................................46
CHARTS OF DEFAULT EXPOSURE VALUES...............................................................................48
6.1.SHORT CONE: 8 INCHES – 20 CM SDD...............................................................................................................49
6.2.LONG CONE: 12 INCHES – 30 CM SDD...............................................................................................................50
CUSTOMIZE DEFAULT EXPOSUR VALUES...............................................................................52
7.1. RESTORING FACTORY VALUES...........................................................................................................................53
X-RAY CALIBRATION PROCEDURE ..........................................................................................54
ERROR MESSAGES.....................................................................................................................55
SUGGESTED MAINTENANCE AND REPAIR ..............................................................................58
10.1. MAINTENANCE AND CLEANING......................................................................................................................58
10.2. DISPOSAL ...........................................................................................................................................................59
SSD - SOURCE TO SKIN DISTANCE AND FOCAL SPOT POSITION..........................................60

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ANNEX A: TECHNICAL DATA....................................................................................................61
A.1 TECHNICAL SPECIFICATIONS..............................................................................................................................61
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

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1.2. INFORMATION FOR THE OPERATOR
Dear customer,
thank you for choosing the X-MIND unity x-ray system. This medical device has been designed and manu-
factured by de Götzen® S.r.l. - ACTEON Group and is the result of many years of experience in the radiology
and medical imaging industry and of advanced electronic applications. This device is a further step forward in
dental radiology.
The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-MIND unity is an
extra-oral source of X-rays, intended to be used for producing diagnostic dental radiographs for treatment of
disease of the teeth, jaw and oral structures. From a clinical application point of view, the X-MIND unity can be
applied in routine, dental radiography examinations involving the diagnosis, treatment, i.e. surgical or interven-
tional, of diseases of the teeth, jaws and oral cavity structures.
Its intended medical indication are:
• generic dentistry;
• dental implantology;
• dental surgery.
The intended population can be whatever, anyway the sustainability to X-ray exposure must be evaluated by
surgeons, dentists and qualied and authorized physicians (refer also to section “SAFETY WARNINGS”)
The Intended user prole is an able-bodied specialized surgeon, dentist and authorized personnel, who meet
the requirements provided by the national laws in force in the country of installation; they must understand the
language of the country where the device is installed. The intended conditions of use are detailed in Annex A
(“Intended Environment”)
This manual has been written and published under the supervision of de Götzen® S.r.l. - ACTEON Group.
It contains all the latest descriptions and features of the product. Although every effort is made to produce
up-to-date and multi-language documentation (since each accompanying document is translated in different
languages), this publication should not be regarded as an infallible guide to current specications. The informa-
tion in this manual is periodically updated; any amendment will be included in subsequent publications without
prior notice by de Götzen® S.r.l. - ACTEON Group.
Contact your dealer to request the latest version of the manual.
In the event of errors, please inform de Götzen® S.r.l. - ACTEON Group promptly.
CAUTION -
!
WARNING
This manual does not include all the recommendations and obligations concerning possession and use of ioniszng radiation sources, since they
differ from country to country. Therefore, only the most common are listed
Operators must refer to the laws in force in their country to meet all legal requirements.
CAUTION -
!
WARNING
For the U.S. market: federal laws restrict these devices to sale by or on the order of a specialized surgeons, dentists and authorized person-
nel, who meet the requirements provided by the national laws in force in the country of installation.
CAUTION -
!
WARNING
This manual describes how to set and use the X-MIND unity x-ray system.
The operator must read and understand the manual before using the medical device.
This manual must be always kept as a reference document.
Before using this device for the rst time, it is essential to thoroughly and carefully read the instructions, CAUTION and WARNING messages
listed in the paragraph General warnings and precautions.
It is mandatory to comply with these instructions every time the device is used.
X-MIND unity is compatible with all kind of X-ray detectors which have been designed and certied for dental intra-oral radiology; in detail,
such a compatibility is ensured by the compliance of the 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).
In case you’re using the X-MIND unity coupled with the Sopix/Sopix2 Inside x-ray digital sensor manufactured by SOPRO – Acteon Group, the
operator is obliged to carefully follow the instructions of both equipments and their relevant accompanying documents, while observing all
the safety measures to ensure the safe and correct functioning of both

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1.2.1. QUALITY DETERMINANTS IN X-RAY INTRAORAL RADIOGRAPHY
Image quality is linked to the precise and accurate acquisition of information from the x-ray beam transmitted
through the patient (ito the x-ray detector). Most problems in dental radiography are not the result of x-ray
equipment failure: the production of consistent and high quality x-ray diagnostic images, concurrent with mini-
mal patient exposure, depends generally on different components: quality performance of equipment, charac-
teristics of the modules used which affect the imaging system resolution (i.e.: x-ray image detector type and
relevant image processing chain, analogue or digital) and optimal performance of the operator.
Among the physical factors for achieving optimum image quality, the following can be considered:
-optimum optical density and Wiener spectrum,
- detectors for radiography must meet the needs of the specic radiological procedure where they will be used
and key parameters are spatial resolution, uniformity of response, contrast sensitivity, dynamic range, acquisi-
tion speed and frame rate
- minimization of motion blurring (using short exposure times),
- minimization of geometric blurring (reducing the focal spot size and/or of the object-lm distance),
- geometric distortions,
- correct positioning: errors in patient positioning when using uncoupled positioning devices during the various
typologies of x-ray examinations may lead to exposure errors, which require additional x-ray exposures, the-
reby increasing the radiation dose adsorbed by the patient.
This means that it is absolutely essential and mandatory that the operator consider the performances not only
of the X-MIND unity equipment itself, but the whole chain of components that bring to the nal x-ray diagnostic
image.
The essential parameters and relevant metrics which describe the performance of dental X-ray system, with
regard to imaging properties and patient dose, methods of testing and whether measured quantities related to
those parameters complying with the specied tolerances, are stated by the respective manufacturers and by
the requirements specied by the respective applicable standards.
Radiographic lms, lm processing, digital x-ray image detectors, and imaging plates are vital parts in the
imaging chain. It is responsibility of the operator to ensure that these components perform in an acceptable
way, with respect to sensitivity, contrast and absence of artifacts. A test of the performance of these compo-
nents shall precede any acceptance test measurement involving the irradiation of the x-ray detectors using the
X-MIND unity1.
!
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 specic regulations in force and to the specications stated
by their respective manufacturers.
1.3. WARRANTY CONDITIONS
Inappropriate use or any arbitrary tampering with this equipment exempts, “de Götzen® S.r.l. - ACTEON
Group”, as manufacturer of the “X-MIND unity” x-ray system, from any service under warranty or from any
other liability
This warranty is valid only if the following precautions are taken. Please refer to the following warranty condi-
tions:
• Any repair, modication, adjustment, or any kind of technical intervention must be performed only
by de Götzen S.r.l. or by a qualied authorized representative
• The installation must be made by professionally qualied technicians according to the regulations in force.
• The system must be installed and used in compliance with the instructions given in this operator’s manual
and in its associated documentation.
• The device shall be used in compliance with the purposes and applications for which it is designed.
1 For example refer to IEC 61223-3-4 and similar standards.

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• The power supply must be adequate to supply the required power indicated in the data contained in the
labels of the device.
• In order to activate your warranty protection carefully read, ll and sign the Warranty Document
provided by the seller, immediately after the installation is completed, together with the installer.
• The system must be checked completely at least each 12 months by professionally qualied 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.
de Götzen S.r.l. is not responsible for any damages caused by any person or thing as a consequence of
non compliance of any or all guidelines contained in all the manuals provided with the X-MIND unity
device.
CAUTION
Non compliance of any of the above mentioned rules and all the indications provided by the manufacturer in the documentation, or suc-
cessively in written paper or electronic format, will result in voiding the warranty of the product and the manufacturer will be discharged
from any obligation, including consequential damages, direct or indirect that may derive to people, things or environment. Furthermore,
the facility representative, customer or employees of the facility, will be liable for any damage and/or incident and/or degeneration of the
health status of a patient, operator, involved people and the surrounding environment.
This will also result in service charges for non-warranty technical assistance.
1.4. TRANSPORT CONDITIONS
The “X-MIND unity” x-ray system travels at the receiver’s own risk.
All claims for damages or mishaps regarding the shipment must be pointed out in the presence of the shipping
agent.
In case of actual or suspected damages, the receiver shall indicate the proper reserves on the way-bill or on the
consignment note.

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1.5. SAFETY WARNINGS
A few safety recommendations are listed here below which must be followed when using the “X-MIND unity
x-ray system”.
CAUTION
GENERAL REQUIREMENTS
• RESPONSIBLE ORGANIZATION is the authority that has the responsibility for the USE and MAINTENANCE of the X-MIND unity system.
The training and preparation of personnel is the responsability of THE RESPONSIBLE ORGANIZATION.
• X-MIND unity is an x-ray generator and must be used and handled only by specialised surgeons, dentists and authorized personnel, who
meet the requirements provided by the national laws in force in the country of installation.
• It is mandatory for the RESPONSIBLE ORGANIZATION to provide a routine and special maintenance schedule for biomedical equipment;
this schedule must be documented for every device and transmitted to the various operating levels (*).The preventive maintenance
(that must be performed at least every twelve months), which includes functional, performance and safety tests of the device, must be
carried out by qualied, authorized professional technicians.It is mandatory to ensure patients’ health and safety and proper X-MIND
unity operation (IEC 60601-1 etc.).These operations must be carried out according to the methods and frequency indicated in this
manual, the installation and maintenance manual and maintenance manual. Failure to comply with this requirement or with the mes-
sages concerning anomalies will release the manufacturer from any liability for direct and indirect injuries to persons and/or damage to
property or the environment. Furthermore, the managers of the facility, customers or collaborators shall be held liable for any damage
and/or accidents and/or degeneration of patients’ or operators’ health or of the surrounding environment. The RESPONSIBLE ORGANIZA-
TION must also provide for the safe and proper use of the equipment. (*) For Italy refer to Presidential Decree 14/01/1997, Legislative
Decree No. 81/2008 (as subsequently amended and modied).
• Operators must know the environmental and operating specications of the device, as well as the procedures to follow in the event of
hazards or emergency stops.
• The X-MIND unity has been designed to acquire radiography images for dental intraoral x-ray imaging. The X-MIND unity medical device
must not be used for x-ray imaging of other body parts.
• 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.
• The RESPONSIBLE ORGANIZATION must comply with the standards and regulations in force concerning the installation of the medical
device in consideration of the place of installation.
• The operator is cautioned to monitor the patient and the parameters of the X-Mind unity throughout the entire duration of the x-ray
examination.
• It is prohibited to modify any part of the X-Mind unity medical device.
• de Götzen S.r.l. - ACTEON Group and its authorized technicians are not required to verify compliance of the installation site with local
standards concerning electrical safety and X-ray protection and with any other directive concerning safety in force in the country of
installation.
• The RESPONSIBLE ORGANIZATIONS of the facility must ensure compliance of the installation site with the local laws in force.
• The Installation of the X-MIND unity system and all its accessories must be executed only by trained, qualied and authorized service
personnel.

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• Before each examination, it is mandatory to apply a disposable protection sheath to the collimator cone (Beam Limiting Device) which
is designed to cover the end part of the X-ray unit, which is more susceptible of being directly contaminated during the X-ray exposure
(class I Medical Device Directive 93/42/EEC and subsequent amendments). It can come into contact with the patient’s skin: verify bio-
compatibility according to the principles given in the ISO 10993 series of standards, refer for details to the disposable use protection’s
instructions for use.
• Before operating the X-MIND unity you must assure that the device has no visible signs of damage.
• The X-MIND unity has been certied by Accredited Laboratories, according to the requirements stated by the applicable standards, to
operate alone or optionally in conjunction with (by means of specic internal connections and congurations) 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 – Acteon Group Disregarding
this warning can put the safety and performances of the X-MIND unity and Sopix/Sopix2 Inside to be irreversibly compromised with the
consequence of damages or injuries to patients, operators and the environment. Failure to comply with this requirement or with the
messages concerning the presence of eventual anomalies will release the manufacturer from any liability for direct and indirect injuries
to persons and/or damage to property or the environment. Furthermore, the managers of the facility, customers or collaborators shall
be held liable for any damage and/or accidents and/or degeneration of patients’ or operators’ health or of the surrounding environ-
ment.
CAUTION
PROTECTION AGAINST RADIATIONS
The «General principles for safeguarding and protecting the personnel and patients» must always be applied during the use of the X-ray
unit.
1. Justication of the practice
2. Optimization of protection principle (ALARA principle)
3. Individual risk and dose limits
• The X-MIND unity is a medical device that generates X-rays; therefore, both the patients and the operator are exposed to risks due to
ionizingionizing radiation. The physician must assess the actual need for X-ray exposure.
• All personnel present during an x-ray examination must comply with safety regulations concerning protection against radiation. For
their own safety, the operator must always keep a distance of more than 2 meters (6 ft.) from the x-ray beam.
• The X-MIND unity medical device must be used in compliance with the local standards in force and with the international directives
concerning radiation protection.
• Compliance with the guidelines and indications provided by an accredited specialist in radiation protection, who will recommend, if
necessary, the additional shields or precautions for every specic case.
• The device installation site must be shielded in compliance with the local standards in force to protect the operator, patient and other
people against X-rays.
• The X-MIND unity device is intended to be used solely by surgeons, dentists and qualied and authorized physicians. The operator must:
o determine, when appropriate, the possible need for sedation and the related operating methods and precautions best suited appro-
priate for the patient
o supervise the entire x-ray examination procedure, paying attention to the indications and information from the unit.
• The device must be used for diagnostic purposes solely by qualied and authorized dentists and/or physicians.
• The operator and other personnelmust keep clear from the patient during the scan.
The personnel involved in the radiographic examination must take all the safety measures concerning radiation protection.

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• It is the operator’s responsibility to protect the patient against unnecessary or excessive radiation doses.
• Additional protection devices (aprons, collars, etc) are required to protect the patient from radiation.
• Before exposing patients with pacemakers, contact the manufacturer of the latter to ensure that the X-rays generated by X-MIND unity
do not interfere with its functionality
• 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.
This symbol indicates X-ray hazards
• According to the paragraph 203.8.5.4 of the IEC 60601-2-65, in case you’re using the X-MIND unity device together with the integrated
Sopix/Sopix2 Inside sensor, it is mandatory to install and use the original rectangular beam limiting device provided by the manufactu-
rer of the X-MIND unity.
CAUTION
MECHANICAL RISK
• Pay extreme attention to the tension of the internal spring of the scissor arm in order to avoid the arm opening outward and causing
injury.
• Check that the installation of the unit complies with the mechanical specications of the support (walls, ceiling, etc..) where it is instal-
led
• Adjustments or any kind of attempt of repairing or disassembling must only be performed by qualied and authorized service personnel.
• The X-MIND unity must not be used in environments or close to environments subjected to mechanical vibrations or mechanical shocks.
• Do not cause overbalancing of the Mobile Version due to improper pushing or leaning the device using other parts respect to the handle,
or with the brakes activated, or with the scissor arm opened.

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CAUTION
ELECTRICAL SAFETY
• The x-ray system contains high voltage. It’s prohibited to inspect internal parts of the system.
• Never attempt to open the x-ray tube head.
• The covers on the X-MIND unity equipment must only be removed by qualied and authorized service personnel.
• The unit must be used only in environments that are in compliance with all the electrical safety standards set forth for medical environ-
ments.
• The unit is NOTwaterproof; it will therefore be necessary to make sure that no water or other liquids penetrate inside the equipment so
as to avoid short circuits or corrosion.
• Always disconnect the x-ray system from the power supply and wait for 2 minutes before commencing to clean or disinfect orperform any
maintenance operations.
• Do not connect the x-ray system to a multiple portable socket outlet (MPSO) or any type of extension cord.
• External equipment intended for connection to signal input, signal output or other connectors shall comply with the relevant product
standard e.g. IEC 60950-1 for IT equipment and the IEC 60601-series for medical electrical equipment. In addition, all such combina-
tions – systems – shall comply with the safety requirements stated in the collateral standard IEC 60601-1-1 or the general standard IEC
60601-1, edition 3, clause 16. Any equipment not complying with the leakage current requirements in IEC 60601-1 shall be kept outside
the patient environment i.e. at least 1.5 m from the patient support.
• Any person who connects external equipment to signal input, signal output or other connectors has formed a system and is therefore res-
ponsible for the system to comply with the requirements. If in doubt, contact qualied medical technician or your local representative.
• It is mandatory to use an isolation device (Separation Device) to isolate the equipment located outside the patient environment from the
equipment located inside the patient environment. In particular such a Separation Device is required when a network or data connection
is made. The requirements on the Separation Device is dened 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 (xed). IT IS NOT ALLOWED TO connect
the equipment to the main supply using a plug.
• Do not touch the USB connector of the x-ray sensor and the patient at the same time.
• NEVER use the device without the presence of the lateral enclosure of the fork (example shown in the picture below) or without the
proper xing of the enclosure on the fork. In case if the Sopix/Sopix2 Inside is installed, the x-ray sensor support must also be present
and properly xed on the cover.
• The cone (Beam Limiting Device) is an APPLIED PART of the system and is classied type B.
• The Sopix/Sopix2 Inside Sensor (optional) is an APPLIED PART of the system and is classied type BF.

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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 specic 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. shall not be used in close proximity of the unit as they could inuence the performance of the system.
• Carefully read the indications relevant to the EMC in the dedicated appendix EMC compatibility of this manual.
CAUTION
PROTECTION AGAINST EXPLOSIONS
The x-ray system MUST NOT be used in the presence of disinfectants, ammable or potentially explosive gases or vapors that might igni-
teand cause damage.
IIf these disinfectants must be used let the vapors completely disperse before turning on the x-ray system.
CAUTION
SYSTEM MODIFICATIONS OR UPGRADES
• Modications or upgrades of the system can be carried out only if advised by de Götzen® S.r.l. and performed by authorized and quali-
ed personnel, using ONLY genuine original spare parts of de Götzen® S.r.l.
• de Götzen® S.r.l. proscribes improper, unauthorized modications or upgrades of the device, in order to avoid malfunctioning resulting
in breakdowns and/or accident for patient, operator and equipment. de Götzen® S.r.l. assumes no responsibility and, consequently,
declines all responsibility with respect to direct or indirect damages to people, the device or environment due to these reasons.
• Do not remove or attempt to remove the plastic covers of the device.
• It is strictly forbidden attempt to repair electronic or mechanical parts by yourself.
• Disregardingthis warning can result in irreversibly compromising the overall safety of the system and can be dangerous for operators,
patients and environment.

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X-RAY SYSTEM OVERVIEW
The “X-MIND unity” is manufactured in compliance with the following European Directives:
▪ 93/42/EEC and subsequent amendements
MEDICAL DEVICES
▪ EURATOM 96/29
IONIZING RADIATIONS
and in compliance with the following American Standard:
▪ American Radiation Performance Standard 21 CFR, Subchapter J
Many protective measures have been adopted in the design and construction of the unit, such as:
protection against the risk of electric injuries, ensured by a grounded protection conductor and in accordance
with the 2nd and 3ed of the IEC 60601-1, together with the applicable worldwide international deviations.
protection against leakage radiation, made negligible by the shielded casing;
protection against excessive radiations, thanks to the immediate activation of the safety device and the ACE
option (if enabled);
protection against continuous service, since the system is designed, according to standards, to not be used in
radioscopy;
protection for the operator against irradiation due to the extendable hand control and cable which allows for a
safety distance of more than 2 meters (6 ft.)
protection against accidental selection of the x-ray technique button selected (FILM or DIGIT) obtained, accor-
ding to standards, by means of
“ELECTRO-MEDICAL” CLASSIFICATION
According to the general safety regulations EC EN 60601-1 2nd and 3rd edition on safety of medical equipment,
the system is classied as: Class I - Type B
“MEDICAL DEVICES” CLASSIFICATION
According to the classication rules indicated in attachment IX of the EEC Directive 93/42 on medical devices
and subsequent amendments, this system is classied as: Class IIb
“EMC” CLASSIFICATION
According to paragraph §4 of the EN 55011, this system is classied as: Group 1 - Class B
22

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Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H
2.1. SYSTEM COMPONENTS
The X-MIND unity x-ray system (Fig.1) consists of the following components:
1 - X-RAY CONTROL UNIT (TIMER)
With it’s clear and highly visible display this component allows for easy and clear selection, of the exposure
settings, the creation of personal settings while alerting you with a visual display and an audible alert in case of
incorrect operation or eventual failures.
This is possible due to the control panel which represents the operator interface between device and operator.
The timer also contains the x-ray exposure switch, which triggers the x-ray when the button is depressed.
The internal sub-mechanical architecture of the X-ray control unit provides the necessary wall framework for
xating the control unit to a wall.
2 - HORIZONTAL BRACKET
The horizontal bracket is available in 3 different lengths and represents the support for the scissor arm. Its
shaft is xed in a dedicated section in the middle of the timer (top or bottom) and allows for 180° movement.
3 - PANTOGRAPH TYPE ARM (SCISSOR)
Due to the new shape and mechanism of the articulating arm, it can be ajusted in height and depth for easy
and precise movement to any position. It is equipped with internal balancing springs and made of extruded
aluminum arms covered by PC-ABS material enclosures.
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.
The expansion chamber guarantees the expansion of oil over the whole range of operating temperatures
according to the technical specications of the device.
The emission of the x-rays is electronically controlled which guarantee a great accuracy of the loading factors.
The tubehead is equipped with an angle scale indicator and is designed for easy handling and positioning of
the tubehead during the x-ray examination.

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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 eld), 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.
6 - COLLIMATOR CONE (Beam Limiting Device)
Made of transparent polycarbonate or PC-ABS, it allows for:
- correct focal spot to skin distance
- dimension, direction and centering of the x-ray beam
- implementation of different x-ray techniques (bisecting and parallel technique)

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Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H
2.2. IDENTIFICATION TAGS
The identication 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:

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X-MIND unity global label
X-MIND unity Control Unit (Timer) Label X-MIND unity X-ray source Label
BEAM LIMITING DEVICE LABEL
TUBEHEAD GRADUATED SCALE
ETL LABEL AND X-RAY WARNING