Acteon XMIND DC Instruction Manual

INSTALLATION &
MAINTENANCE MANUAL
INSTALLATION & MAINTENANCE MANUAL • XMIND DC • W1100100 • V1 • (15) • 12/2015 • NXDCEN020B

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INSTALLATION & MAINTENANCE MANUAL • XMIND DC • W1100100 • V1 • (15) • 12/2015 • NXDCEN020B
ENGLISH
MANUFACTURER
de Götzen®S.r.l. - a company of ACTEON Group
Via Roma, 45
21057 OLGIATE OLONA (VA) – ITALY
Tel. [phone]
Fax [phone]
www.degotzen.com - www.acteongroup.com
E-mail: [email protected]
For technical support:
[email protected]
www.acteongroup.com
ITALY
For information and technical assistance, contact the manufacturer
Direct Tel.: [phone]
[email protected]
WORLDWIDE
Contact your authorised local dealer.
Refer to the list in the following page to nd the authorised dealer near you.
THE RADIOGRAPHIC SYSTEM DESCRIBED IN THIS MANUAL REFERS TO A WALL INSTALLATION.

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INSTALLATION & MAINTENANCE MANUAL • XMIND DC • W1100100 • V1 • (15) • 12/2015 • NXDCEN020B
FRANCE
SATELEC ACTEON GROUP
17 avenue Gustave Eiffel - B.P. 30216 33708 Mérignac-Cedex, FRANCE
Tel: [phone] - Fax: [phone] -
E-mail: [email protected]
GERMANY
ACTEON GERMANY GmbH
Industriestrasse 9 D-40822 Mettmann, GERMANY
Tel: [phone] - Fax: [phone]
E-mail: [email protected]
SPAIN
ACTEON MEDICO-DENTAL IBERICA S.A.U.
Polígono Industrial Can Clapers - Avda. Principal 11H - Sentmenat, 08181 Barcelona, SPAIN
Tel: [phone] - Fax: [phone]
E-mail: [email protected]
U.K.
ACTEON UK
Unit 1B - Steel Close - Eaton Socon – St. NEOTS Cambs - PE19 8TT, UNITED KINGDOM
Tel : [phone] - Fax: [phone]
E-mail: [email protected]
USA
ACTEON Inc.
124 Gaither Drive, Suite 140 Mount Laurel, NJ 08054, USA
Tel:[phone] - Fax:++ 1 8562224726
E-mail: [email protected]
SOUTH AMERICA
ACTEON LATIN AMERICA
Bogotà - COLOMBIA
Celular: [phone]
e-mail : [email protected]
RUSSIA
ACTEON RUSSIA
Valdajski Proezd 16 – ofce 253 - 125445 Moscow - RUSSIA
Tel./Fax. [phone]
e-mail : sergey[email protected]
THAILAND
ACTEON THAILAND LTD
23/45 Sorachai Building 16th oor - Sukumvit 63 Road, Klongton Nua - Wattana, BANGKOK
10110 - THAILAND
Tel. [phone] - Fax. [phone]
e-mail : [email protected]
CHINA
ACTEON CHINA
Ofce 401 - 12 Xinyuanxili Zhong Street - Chaoyang District - BEIJING 100027 - CHINA
Tel. [phone] - Fax. [phone]
e-mail : [email protected]
TAIWAN
TAIWAN (R.O.C.)
14F.-1, No.433, Jingping Rd. Jhonghe Dist., New Taipei City 23563
Tel: [phone]
E-mail: [e-mail]
KOREA
ACTEON KOREA Corp.
8F Hanil B/D - 132-4 1Ga Bongrae-dong - JOONG-GU – SEOUL - KOREA
Tel. [phone] - Fax. [phone]
e-mail: [e-mail]
INDIA
ACTEON INDIA
B-94, GIDC Electronic Estate - Sector 25 – GANDHINAGAR 382028 Gujarat - INDIA
Tel. [phone] - Fax. [phone]
e-mail: [email protected]
MIDDLE EAST
ACTEON MIDDLE EAST
Numan Center - 2nd Floor N° 205 - Gardens Street - PO Box 5746 - 11953 AMMAN - JORDAN
Tel. [phone] - Fax. [phone]
e-mail : [email protected]
AUSTRALIA
NEW ZEALAND
ACTEON AUTRALIA/NEW ZEALAND
Suite 119, 30-40 Harcourt Parade, Rosebery NSW 2018 - Australia
Tel. [phone] - Fax. [phone]
e-mail : sandy[email protected]

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INSTALLATION & MAINTENANCE MANUAL • XMIND DC • W1100100 • V1 • (15) • 12/2015 • NXDCEN020B
ENGLISH
de Götzen® S.r.l. – ACTEON Group RESERVES ITSELF THE RIGHT TO MODIFY THE PRODUCTION
AND THE MANUAL WITHOUT NOTICE.
IT IS PROHIBITED TO MODIFY, COPY, REPRODUCE, DISPLAY, SHARE, DISCLOSE AND PUBLISH
THIS MANUAL AND ALL OTHER DOCUMENTS REFERRING TO “Xmind®dc” IN ANY FORM
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.

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INSTALLATION & MAINTENANCE MANUAL • XMIND DC • W1100100 • V1 • (15) • 12/2015 • NXDCEN020B
CONTENTS
CHAPTER 1......................................................................................................................................... 7
1.1. PRELIMINARY INFORMATION ...........................................................................................................7
1.2. INFORMATION FOR THE INSTALLER.................................................................................................7
1.3. WARRANTY CONDITIONS ..................................................................................................................8
1.4. TRANSPORT CONDITIONS................................................................................................................. 8
1.5. SAFETY WARNINGS.............................................................................................................................9
CHAPTER 2....................................................................................................................................... 13
2.1. RADIOGRAPHIC SYSTEM..................................................................................................................13
2.2. SYSTEM COMPONENTS....................................................................................................................14
2.3. OVERALL DIMENSIONS ....................................................................................................................15
2.4. IDENTIFICATION TAGS .....................................................................................................................18
CHAPTER 3....................................................................................................................................... 21
3.1. INSTALLATION SPECIFICATIONS.....................................................................................................21
CHAPTER 4....................................................................................................................................... 23
4.1. INSTALLATION...................................................................................................................................23
4.2. UNPACKING.......................................................................................................................................23
4.3. ASSEMBLING THE WALL PLATE.......................................................................................................24
4.4. ASSEMBLING THE BRACKET ............................................................................................................25
4.5. ASSEMBLING THE PANTOGRAPH ARM ..........................................................................................26
4.6. ASSEMBLING THE TIMER .................................................................................................................27
4.7. ASSEMBLING THE TUBEHEAD .........................................................................................................28
4.8. BALANCING THE PANTOGRAPH ARM ............................................................................................30
CHAPTER 5....................................................................................................................................... 33
5.1. ELECTRIC CONNECTION ..................................................................................................................33
CHAPTER 6....................................................................................................................................... 36
6.1. CONFIGURATION..............................................................................................................................36
6.2. CHANGING THE CONFIGURATION .................................................................................................37
CHAPTER 7....................................................................................................................................... 40
7.1. START UP............................................................................................................................................40
CHAPTER 8....................................................................................................................................... 41
8.1. CHECKING THE INSTALLATION.......................................................................................................41
8.2. CHECKING THE EXPOSURE FACTORS .............................................................................................42
CHAPTER 9....................................................................................................................................... 44
9.1. DIAGNOSTIC......................................................................................................................................44
CHAPTER 10..................................................................................................................................... 46
10.1. CALIBRATION OF THE TUBEHEAD ................................................................................................46
CHAPTER 11..................................................................................................................................... 47
11.1. ERROR MESSAGES...........................................................................................................................47
CHAPTER 12..................................................................................................................................... 49
12.1. SUGGESTED MAINTENANCE .........................................................................................................49
12.2. CLEANING THE OUTER SURFACE..................................................................................................49
CHAPTER 13..................................................................................................................................... 51
13.1. REPLACEMENT OF FUSES...............................................................................................................51
CHAPTER 14..................................................................................................................................... 53
14.1. REPAIR..............................................................................................................................................53
13.2. DISPOSAL.........................................................................................................................................53
CHAPTER 15..................................................................................................................................... 54
15.1. SPARE PARTS ...................................................................................................................................54
ANNEXES ......................................................................................................................................... 65
A1. TECHNICAL SPECIFICATIONS ...........................................................................................................65
ANNEX 2 .......................................................................................................................................... 68
A2. INTENDED ENVIRONMENT...............................................................................................................68
ANNEX 3 .......................................................................................................................................... 69
A3. LIST OF INTERNATIONAL STANDARDS AND DIRECTIVES .............................................................69
ANNEX 4 .......................................................................................................................................... 70
A4. DOSIMETRIC INDICATIONS..............................................................................................................70
ANNEX 5 .......................................................................................................................................... 73
A5. ELECTROMAGNETIC COMPATIBILITY..............................................................................................73
ANNEX 6 .......................................................................................................................................... 77
A6. DRAWINGS AND DIMENSIONS........................................................................................................77
ANNEX 7 .......................................................................................................................................... 79
A7. INSTALLATION ELECTRICAL SCHEME..............................................................................................79

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CONTROL PANEL
MAIN SWITCH
DISPLAY
RADIOGRAPHIC DISTANCE
INDICATOR
KEY TO INCREASE
EXPOSURE TIME
SELECTION OF TYPE OF
PATIENT’S PHYSIQUE
RADIOGRAPHIC CURRENT
INDICATOR
OCCLUSAL EXAM
BITE-WING EXAM
KEY SWITCH
MALFUNCTIONING
INDICATOR
PAUSE INDICATOR
X-RAY OUTPUT SIGNAL
MANDIBULARY LOWER
TEETH
MAXILLARY LOWER
TEETH
MEMORY
RADIOGRAPHIC VOLTAGE
INDICATOR
TUBEHEAD TYPE
INDICATOR
KEY TO DECREASE
EXPOSURE TIME
X-RAY KEY
CONTROL BUTTON
DIGITAL RADIOGRAPHIC
TECHNIQUE
CONVENTIONAL
RADIOGRAPHIC TECHNIQUE
TEBEHEAD SELECTION

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INSTALLATION & MAINTENANCE MANUAL • XMIND DC • W1100100 • V1 • (15) • 12/2015 • NXDCEN020B
CHAPTER 1
1.1. PRELIMINARY INFORMATION
Before beginning to use the “Xmind®dc” radiographic system, it is mandatory to carefully read and follow the
instructions contained herein, so as to obtain the best possible performance and to assure the safety of the
patient, operator, device and environment.
Always pay close attention to the
CAUTION
WARNING
PLEASE NOTE
messages when operating the system.
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 radiographic system’s performance.
PLEASE NOTE
PLEASE NOTE serve to give special indications so as to facilitate maintenance or make important information clearer.
1.2. INFORMATION FOR THE INSTALLER
CAUTION
The installer is responsible for the installation, with regards to the system safety and operation.
For safe and reliable installation of the “Xmind®dc” radiographic system it is advisable to:
- check that the voltage mentioned in the rating plate matches the line voltage;
- install the radiographic system according to the procedures described in this manual;
- provide the user with any information regarding the use of the radiographic system according to what stated
in the manual;
- certify the work done by a “Declaration of Conformity;
- return to “de Götzen® S.r.l.” the warranty certicate duly lled in: if this is not done, the warranty is not valid.
11

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1.3. WARRANTY CONDITIONS
Inappropriate use or any arbitrary tampering with the equipment exempt de Götzen® S.r.l. – ACTEON Group,
as manufacturer of the “Xmind®dc” radiographic system, from any service under warranty or from any other
liability.
The warranty is valid only if the following precautions are taken:
- any repairs, modications, adjustments, re-calibrations must be performed only by de Götzen® S.r.l. – ACTEON
Group;
- 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 Manual and for the
purposes and applications for which it was designed;
- the power supply must be adequate to supply the required power indicated in the radiographic system’s
nameplate data;
- in order to safeguard one’s warranty rights, please ll in the enclosed Warranty Document, immediately after
the installation is completed, together with the technician;
- the system must be checked completely at least each 12 months by professionally qualied technicians according
to the regulation in force. Use the manuals provided with the device “Xmind®dc” for reference.
- in case of repair, please use only spare parts from the manufacturer of the “Xmind®dc”. Otherwise basic safety
and essential performances of the device will not be guaranteed.
de Götzen® S.r.l. – ACTEON Group 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
“Xmind®dc” device.
CAUTION
Non compliance of any of the above mentioned rules and all the indications provided by the manufacturer in the documentation, or successively
in written paper or electronic format, will result in losing the warranty of the product and the manufacturer will be discharged from any obliga-
tion, including consequential damages, direct or indirect that may derive to people, things or environment. Furthermore, the facility represen-
tative, 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.
1.4. TRANSPORT CONDITIONS
The “Xmind®dc” radiographic system travels at the receiver’s own risk.
All claims for damage or miscarriage regarding the shipment must be pointed out in the presence of the shipping
agent.
In case of miscarriages, or actual or suspected damage, 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 which should be followed when using the “Xmind®dc” radiographic system are
listed here below.
CAUTION
GENERAL REQUIREMENTS
GENERAL REQUIREMENTS
RESPONSIBLE ORGANIZATION is the authority that has the responsibility for the USE and MAINTENANCE of the “Xmind®dc” radiographic system.
The training and preparation of personnel is the responsibility of THE RESPONSIBLE ORGANIZATION.
“Xmind®dc” radiographic system 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 medical equipment; this sche-
dule must be documented for every device and transmitted to the various operating levels (*). The preventive maintenance (that must be perfor-
med at least every 12 months), which includes functional, performance and safety tests of the device, must be carried out by qualied, autho-
rized professional technicians. It is mandatory to ensure patients’ health and safety and proper “Xmind®dc” radiographic system operation (IEC
60601-1 etc.). These operations must be carried out according to the methods and frequency indicated in this manual and in the installation and
maintenance manual. Failure to comply with this requirement or with the messages 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 ORGANIZATION 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.
“Xmind®dc” radiographic system has been designed to acquire radiography images for dental intraoral X-ray imaging. The “Xmind®dc” 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 “Xmind®dc” radiographic system. 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 “Xmind®dc” radiographic system throughout the entire duration of
the X-ray examination.
It is prohibited to modify any part of the “Xmind®dc” 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.
Before each examination, it is mandatory to apply a disposable protection sheath to the collimator cone (Beam Limiting Device) 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 biocompatibility according to the prin-
ciples given in the ISO 10993 series of standards, refer for details to the disposable use protection’s instructions for use.
Before operating the “Xmind®dc” radiographic system the operator must assure that the device has no visible signs of damage.

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CAUTION
PROTECTION AGAINST RADIATIONS
PROTECTION AGAINST RADIATIONS
“The general principles regarding safety and protection of workers and people” must always be applied when using the unit:
1. Justication of the practice
2. Protection Optimisation
3. Reduction of the limits of individual dose and risks
The “Xmind®dc” 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.
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.) and out of the path of the X-ray beam, in order to avoid the exposi-
tion to the stray radiation and residual radiation.
The “Xmind®dc” medical device must be used in compliance with the local standards in force and with the international directives concerning
radiation protection.
The device must comply 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 “Xmind®dc” device is intended to be used solely by surgeons, dentists and qualied and authorized physicians. The operator must:
- determine, when appropriate, the possible need for sedation and the related operating methods and precautions best suited appropriate for
the patient
- supervise the entire X-ray examination procedure, paying attention to the indications and information from the unit.
The device must be used only for diagnostic purposes by qualied and authorized dentists and/or physicians.
The operator and other personnel must keep clear from the patient during the scan.
The personnel involved in the radiographic examination must take all the safety measures concerning radiation protection.
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 “Xmind®dc” do not
interfere with its functionality.
.
“Xmind®dc” 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 condition before starting
the exposure.
This symbol indicates X-ray hazard.

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CAUTION
MECHANICAL RISK
Before removing the tubehead from the positioning arm, RELEASE THE SPRING.
The sudden opening of the joint may cause damage to people and/or things.
Check that the installation of the unit complies with the mechanical specications of the support (walls, ceiling, etc..) where it is installed.
Adjustments or any kind of attempt of repairing or disassembling must only be performed by qualied and authorized service personnel.
The “Xmind®dc” must not be used in environments or close to environments subjected to mechanical vibrations or mechanical shocks.
CAUTION
ELECTRIC SAFETY
The radiographic system contains high voltage. It is prohibited to inspect internal parts of the system.
Never attempt to open the X-ray tubehead.
The covers on the “Xmind®dc” radiographic system 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 electrical safety standards set forth for medical environments.
To avoid the risk of electric shock, this device must only be connected to a supply mains with protective earth.
The unit is NOT equipped with protections against penetration of liquids; it will therefore be necessary to make sure that no water or other
liquids penetrate inside in order to avoid short circuits or corrosion.
Always disconnect the radiographic system from the power supply and wait for 2 minutes before beginning to clean, disinfect and maintenance
operations.
Do not connect the X-ray system to a multiple portable socket outlet (MPSO) nor to 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 combinations – systems – shall
comply with the safety requirements stated in the general standard CEI EN 60601-1, edition 3, clause 16. Any equipment not complying with the
leakage current requirements in CEI EN 60601-1 shall be kept outside the patient environment i.e. at least 1,5 m from the patient support.
It is mandatory to use an isolation device (Separation Device) to isolate the equipment located outside the patient environment from the equip-
ment 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 CEI EN 60601-1, edition 3, clause 16.
For the wall version of “Xmind®dc”:
based on the CEI EN 60601-1, the installation is a permanent type (xed). IT IS NOT ALLOWED TO connect the equipment to the main supply using
a plug.
The cone (beam limiting device) is an APPLIED PART of the system and it is classied as type B.

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CAUTION
EMC COMPATIBILITY
EMC requirements must be considered and the “Xmind®dc” must be installed and used accordingly to the specic EMC information provided in
the accompanying documents.
The device complies with the EMC (Electromagnetic Compatibility) requirements, according to CEI EN 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 A5. EMC compatibility of this manual.
CAUTION
PROTECTION AGAINST EXPLOSIONS
The radiographic system MUST NOT be used in the presence of disinfectant, ammable or potentially explosive gases or vapours that might
catch re and cause damage.
In case these disinfectants have to be used, let the vapour completely disperse before turning on the radiographic 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. – ACTEON Group and performed by authorized
and qualied personnel, using ONLY genuine original spare parts of de Götzen® S.r.l. – ACTEON Group.
de Götzen® S.r.l. – ACTEON Group proscribes improper, unauthorized modications or upgrades of the device, in order to avoid malfunctions
resulting in breakdowns and/or accident for patient, operator and equipment. de Götzen® S.r.l. – ACTEON Group 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 to attempt to repair electronic or mechanical parts by yourself.
Disregarding this 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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CHAPTER 2
2.1. RADIOGRAPHIC SYSTEM
The “Xmind®dc” 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
and in compliance with the following American Standard:
} American Radiation Performance Standard 21 CFR, Subchapter J, Sec. 1020.30 and 1020.31
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
- protection against leakage radiation, made negligible by the shielded casing
- protection against excessive radiations, thanks to the immediate activation of the safety device
- protection against continuous service, since the system is designed, according to standards, not to allow use
in radioscopy
- protection for the patient against dangerous radiations, obtained by means of the high frequency technology
capable of producing a constant and hard radiation
- protection against exposure mistakes obtained with the high frequency technology which is unaffected by
voltage uctuation and consequently capable to guarantee extremely accurate exposure parameters
- protection for the operator against irradiation ensured by the extensible cable of the hand control which
allows for a safety distance of more than 2 meters (6 ft.)
- protection against involuntarily selection of radiographic technique (FILM or DIGIT) obtained, according to
standards, by means of the conrming on the selection key
“ELECTRO-MEDICAL” CLASSIFICATION
According to paragraph §6 of the general safety regulations CEI EN 60601-1: 2007 on safety of medical equip-
ment, 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 the system is classied as: Class IIb.
“E.M.C.” CLASSIFICATION
According to paragraph §4 of the CEI EN 55011, the system is classied as: Group 1 – Class B
22

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2.2. SYSTEM COMPONENTS
“Xmind®dc” radiographic system (Fig. 1) consists of:
1. “Xmind®dc” TIMER
The timer is the control panel used to manage the exposure times and to safely use the tubehead.
To make the exposure, the control button with safety key is available.
The timer can be connected to n° 2 dc tubeheads.
2. WALL PLATE
3. BRACKET
The horizontal bracket is available in 3 different lengths (110 cm, 80 cm, 40 cm) and represents the support for
the pantograph arm. Its shaft is xed in a dedicated section of the timer (top or bottom) and allows for 180°
movement.
4. PANTOGRAPH ARM
Thanks to the new shape and new mechanisms of the positioning arm, it can be adjusted in height and depth
in order to precisely explore any spot in its reach.
It is made of light alloy with an ABS coating.
5. TUBEHEAD “Xmind®dc”
The intra-oral “Xmind®dc” is a tubehead type and its light alloy housing is divided into two compartments.
The high voltage transformer, the X-ray tube and the expansion chamber are submerged in highly dielectric
insulating oil inside a light alloy container.
The expansion chamber guarantees an adequate compensation to oil expansion for the entire temperature
range.
The X-ray tube is located in the back part of the container, allowing a source-skin distance 50% higher than
traditional structures.
In the second compartment the main electronic board and the control electronic board are placed.
6. CONE
The collimator cone or Beam Limiting Device represents the applied part of the device. Made of the transparent
polycarbonate, it allows:
- the correct distance between focal spot and skin
- dimension, direction and centering of X-ray beam
- the realization of different radiographic technique (bisecting and parallel technique).
During X-ray exposition, the collimator cone comes in contact with the skin of the patient. Before each exam, it is

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necessary to apply to the cone a disposable protective cover designed to cover the end part of the X-ray generator.
Such protection has two functions: avoid cross-contamination (from patient to patient) and prevent the possibi-
lity of inammations or other types of reactions of the skin caused by contact with the material that constitutes
the cone.
OPTIONAL ACCESSORIES
}SECOND CONTROL BUTTON
}Xmind®dc LIGHT (Rx signalling lamp for external use)
}Xmind®dc ECB (remote control button)
PLEASE NOTE
For the installation of the optional accessories, refer to the specic installation manuals supplied.
2.3. OVERALL DIMENSIONS
Fig. 2A, 2B, 2C give the overall dimensions of the possible supply conditions:
BRACKET 400: L = 16” 9/64
BRACKET 800: L = 82,5cm – 32” 31/64
BRACKET 1100: L = 110cm – 43” 5/16
BRACKET 400

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BRACKET 800
BRACKET 1100

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Fig. 3 and 4 show the typical dimensions of the radiographic system:

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2.4. IDENTIFICATION TAGS
The identication tags on the tubehead, on the timer and on the cone indicate the model number, the serial
number, the manufacturing date and the symbols of the main technical characteristics.
2.3.1. TUBEHEAD
Model 230 V
Model 115 V
2.3.2. TIMER
Model 230 V
Model 115 V

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CONE
GRADUATED SCALE
PICTOGRAMS USED

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SYMBOL INDICATING THE MANUFACTURER
THIS SYMBOL GUARANTEES THAT THE RADIOGRAPHIC SYSTEM COMPLIES WITH THE
REGULATIONS CONTAINED IN THE EUROPEAN DIRECTIVE EEC 93/42 REGARDING MEDICAL
DEVICES
SIZE OF THE FOCAL SPOT
THE DEGREE OF PROTECTION AGAINST DIRECT AND INDIRECT ELECTRIC CONTACTS IS B
TYPE
SYMBOL INDICATING THE SERIAL NUMBER
SYMBOL INDICATING DANGER DUE TO IONISING RADIATIONS
X-ray EMISSION (IEC 60417)
PAUSE (IEC 60417)
ATTENTION, REFER TO THE ATTACHED DOCUMENTS
REFER TO MANUAL’S INSTRUCTIONS
WEEE (Waste Electrical and Electronic Equipment) SYMBOL, IN CONFORMITY WITH 2012/19/
CE DIRECTIVE AND EN 50419 STANDARD.