OPERATOR’S MANUAL

OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D

 ENGLISH

MANUFACTURER

de Götzen® S.r.l. - a company of ACTEON Group

Via Roma, 45
21057 OLGIATE OLONA (VA) – ITALY
Tel. +39 0331 376760
Fax +39 0331 376763

www.acteongroup.com

For information and technical assistance, contact the manufacturer

[email protected]

Page 2 of 61 OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D

 ENGLISH

THE RADIOGRAPHIC SYSTEM DESCRIBED IN THIS MANUAL REFERS BOTH TO A WALL INSTALLATION AND TO THE
MOBILE VERSION.

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 “x-mind 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.

OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D Page 3 of 61

 ENGLISH

CONTENTS
CONTROL PANEL .............................................................................................................................................6
CHAPTER 1 ........................................................................................................................................................7
1.1. PRELIMINARY INFORMATION ...........................................................................................................................7
1.2. Information for the operator ............................................................................................................................7
1.3. QUALITY DETERMINANTS IN X-ray INTRAORAL RADIOGRAPHY ..................................................................8
1.4. WARRANTY CODITIONS .....................................................................................................................................9
1.5. TRANSPORT CONDITIONS .................................................................................................................................9
1.6. SAFETY WARNINGS .............................................................................................................................................9
CHAPTER 2 ......................................................................................................................................................14
2.1. RADIOGRAPHIC SYSTEM ..................................................................................................................................14
2.2. SYSTEM COMPONENTS ....................................................................................................................................15
2.3. IDENTIFICATION TAGS .....................................................................................................................................16
CHAPTER 3 ......................................................................................................................................................19
3.1. CONFIGURATION ..............................................................................................................................................19
CHAPTER 4 ......................................................................................................................................................21
4.1. INSTRUCTIONS FOR USE..................................................................................................................................21
CHAPTER 5 ......................................................................................................................................................28
5.1. CHART OF DEFAULT EXPOSURE VALUES ........................................................................................................28
CHAPTER 6 ......................................................................................................................................................35
6.1. PROGRAMMING DEFAULT EXPOSURE VALUES .............................................................................................35
6.2. RESTORING ORIGINAL VALUES .......................................................................................................................37
CHAPTER 7 ......................................................................................................................................................38
7.1. DIAGNOSTIC ......................................................................................................................................................38
CHAPTER 8 ......................................................................................................................................................39
8.1. ERROR MESSAGES.............................................................................................................................................39
CHAPTER 9 ......................................................................................................................................................41
9.1. VERIFICATION OF THE EXPOSURE FACTORS .................................................................................................41
CHAPTER 10 ....................................................................................................................................................43
10.1. SUGGESTED MAINTENANCE .........................................................................................................................43
10.2. CLEANING THE OUTER SURFACES ................................................................................................................43
CHAPTER 11 ....................................................................................................................................................45
11.1. REPAIR..............................................................................................................................................................45
11.2. DISPOSAL.........................................................................................................................................................45
ANNEX 1 .........................................................................................................................................................46
A1. TECHNICAL SPECIFICATIONS ...........................................................................................................................46
ANNEX 2 .........................................................................................................................................................50
A2. INTENDED ENVIRONMENT...............................................................................................................................50
ANNEX 3 .........................................................................................................................................................51
A3. LIST OF INTERNATIONAL STANDARDS AND DIRECTIVES .............................................................................51
ANNEX 4 .........................................................................................................................................................52
A4. DOSIMETRIC INDICATIONS ..............................................................................................................................52
ANNEX 5 .........................................................................................................................................................55
A5. ELECTROMAGNETIC COMPATIBILITY ..............................................................................................................55
ANNEX 6 .........................................................................................................................................................59
A6. DRAWINGS AND DIMENSIONS ........................................................................................................................59
ANNEX 7 .........................................................................................................................................................61
A7. INSTALLATION ELECTRICAL SCHEME ..............................................................................................................61

Page 4 of 61 OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D

 ENGLISH

CONTROL PANEL

OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D Page 5 of 61

 ENGLISH

CHAPTER 1
1.1. PRELIMINARY INFORMATION

Before beginning to use the “x-mind 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 identifies those occurrences which might compromise the operator’s personal safety or cause injuries to people.

! WARNING

The word WARNING identifies 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 OPERATOR

Dear Customer,
thanks for having chosen the “x-mind dc” radiographic system.
It is designed and manufactured by de Götzen® S.r.l. – ACTEON Group and is the result of many years of experience
in the field of radiology and in the application of advanced electronics.
This high performing system represents a further development of technological research at the service of dental
radiography.

The “x-mind dc” is an X-ray generator for dental intra-oral X-ray imaging, particularly, “x-mind dc” is an extra-
oral source of X-rays, intended to be used for producing diagnostic dental radiographs for treatment of disease
of teeth, jaw and oral structures.
From a clinical point of view, “x-mind dc” can be applied in routine dental radiography examinations involving
the diagnosis, treatment, i.e. surgical or interventional, of disease of the teeth, jaw and oral cavity structures.
Its intended medical applications are:
• Generic dentistry
• Dental implantology
• Dental surgery

The intended population can be whatever, anyway the sustainability of the X-ray exposure must be evaluated
by surgeons, dentists and qualified and authorized physicians.
The Intended user profile is an able-bodied specialized surgeon, dentist and authorized personnel, who meet

Page 6 of 61 OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D

 ENGLISH

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 A2
(“Intended Environment”).

PLEASE NOTE

This manual does not contain all the recommendations and the obligations relative to the possession of a source of ionising radiations – since
they do vary from Country to Country – but only the most common ones.
The user must consult his country’s legislation so as to fulfil all local obligations.

! WARNING

This manual describes how to set and use the “x-mind dc” 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 first time, it is essential to thoroughly and carefully read the instructions, CAUTION and WARNING messages
listed in the present chapter.
It is mandatory to comply with these instructions every time the device is used.
“x-mind dc” is compatible with all kind of X-ray detectors which have been designed and certified for dental intra-oral radiology; in detail,
such a compatibility is ensured by the compliance of the “x-mind dc” device with the basic safety and essential performance requirements
of the IEC 60601-2-65: 2012.

1.3. 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 (i.e., 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
minimal patient exposure, depends generally on different components:
quality performance of equipment, characteristics 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 specific radiological procedure where they will be used
and key parameters are spatial resolution, uniformity of response, contrast sensitivity, dynamic range, acquisition
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-film 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, thereby
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 dc” equipment itself, but the whole chain of components that bring to the final 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 comply with the specified tolerances, are stated by the respective manufacturers and by the
requirements specified by the respective applicable standards.
Radiographic films, film 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 components shall
precede any acceptance test measurement involving the irradiation of the X-ray detectors using the “x-mind dc”.

OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D Page 7 of 61

 ENGLISH

! WARNING

It is full responsibility of the operator and RESPONSIBLE ORGANIZATIONS of the “x-mind dc” to check that any kind of X-ray detectors used
with the “x-mind dc” are in compliance with the requirements stated by their specific regulations in force and to the specifications stated
by their respective manufacturers.

1.4. WARRANTY CODITIONS

Inappropriate use or any arbitrary tampering with the equipment exempt de Götzen® S.r.l. – ACTEON Group,
as manufacturer of the “x-mind 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, modifications, adjustments, recalibrations must be performed only by de Götzen® S.r.l. – ACTEON
Group
- the installation must be made by professionally qualified 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 fill 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 qualified technicians
according to the regulation in force. Use the manuals provided with the device “x-mind dc” for reference.
- In case of repair, please use only spare parts from the manufacturer of the “x-mind 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 damage caused by any person or thing as a
consequence of non-compliance of any of the guidelines contained in all the manuals provided with the
“x-mind dc” device.

CAUTION

No 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.

1.5. TRANSPORT CONDITIONS

The “x-mind 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.

1.6. SAFETY WARNINGS

A few safety recommendations which should be followed when using the “x-mind dc” radiographic system are
listed here below.

Page 8 of 61 OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D

 ENGLISH

CAUTION

GENERAL REQUIREMENTS

RESPONSIBLE ORGANIZATION is the authority that has the responsibility for the USE and MAINTENANCE of the “x-mind dc” radiographic system.
Training and preparation of personnel is responsibility of THE RESPONSIBLE ORGANIZATION.

“x-mind 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
schedule must be documented for every device and transmitted to the various operating levels (*). The preventive maintenance (that must be
performed at least every 12 months), which includes functional, performance and safety tests of the device, must be carried out by qualified,
authorized professional technicians. It is mandatory to ensure patients’ health and safety and proper “x-mind 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 will 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 modified).

Operators must know the environmental and operating specifications of the device, as well as the procedures to follow in the event of hazards or
emergency stops.

“x-mind dc” radiographic system has been designed to acquire radiography images for dental intraoral X-ray imaging. The “x-mind dc” medical
device must not be used for X-ray imaging of other body parts.

Carefully follow the instructions of this manual to install, operate and maintain the “x-mind 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 “x-mind dc” radiographic system throughout the entire duration of
the X-ray examination.

It is prohibited to modify any part of the “x-mind 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 to the collimator cone (Beam Limiting Device) a disposable protection sheath 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
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 dc” radiographic system you must assure that the device has no visible signs of damage.

OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D Page 9 of 61

 ENGLISH

CAUTION

PROTECTION AGAINST RADIATIONS

“The general principles regarding safety and protection of workers and people” must always be applied when using the unit:
1. Justification of the practice
2. Protection Optimisation
3. Reduction of the limits of individual dose and risks

The “x-mind 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.

The “x-mind 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, additional shields or precautions for every specific 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 dc” device is intended to be used solely by surgeons, dentists and qualified and authorized physicians. The operator must:
- determine, when appropriate, the possible need for sedation and the related operating methods and appropriate precautions 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 qualified 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 “x-mind dc” do not
interfere with its functionality.

“x-mind 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.

Page 10 of 61 OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D

 ENGLISH

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 specifications 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 qualified and authorized service personnel.

The “x-mind 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 “x-mind dc” radiographic system must only be removed by qualified 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 cleaning and disinfecting 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 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.

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 defined in IEC 60601-1, edition 3, clause 16.

For the wall version of “x-mind dc”:

based on the IEC 60601-1, the installation is a permanent type (fixed). 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 classified as type B.

OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D Page 11 of 61

 ENGLISH

CAUTION

EMC COMPATIBILITY

EMC requirements must be considered and the “x-mind dc” must be installed and used accordingly with the specific EMC information provided in
the accompanying documents.

The device complies with the EMC (Electromagnetic Compatibility) requirements, 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 influence 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, flammable or potentially explosive gases or vapours that might
catch fire 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

Modifications or upgrades of the system can be carried out only if advised by de Götzen® S.r.l. – ACTEON Group and performed by authorized
and qualified personnel, using ONLY genuine original spare parts of de Götzen® S.r.l. – ACTEON Group.

de Götzen® S.r.l. – ACTEON Group proscribes improper, unauthorized modifications 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.

Page 12 of 61 OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D

 ENGLISH

CHAPTER 2
2.1. RADIOGRAPHIC SYSTEM

The “x-mind 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 fluctuation 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 confirmation 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 equipment,
the system is classified as: Class I - Type B

“MEDICAL DEVICES” CLASSIFICATION

According to the classification rules indicated in attachment IX of the EEC Directive 93/42 on medical devices and
subsequent amendments the system is classified as: Class IIb

“E.M.C.” CLASSIFICATION
According to paragraph §4 of the CEI EN 55011, the system is classified as: Group 1 – Class B

OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D Page 13 of 61

 ENGLISH

2.2. SYSTEM COMPONENTS

Fig. 1

“x-mind dc” radiographic system (Fig. 1) consists of:

1. x-mind 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 cc tubeheads.

2. 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 fixed in a dedicated section of the timer (top or bottom) and allows for 180°
movement.

3. PANTOGRAPH TYPE 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.

4. TUBEHEAD
The intra-oral “x-mind 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.

5. CONE
The collimator cone or Beam Limiting Device represents the applied part of the device. Made of the transparent
polycarbonate, it ensures:
- the correct distance between focal spot and skin
- dimension, direction and centering of X-ray beam
- the realization of different radiographic technique (biting and parallel technique).

Page 14 of 61 OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D

 ENGLISH

During X-ray exposition, the collimator cone comes in contact with the skin of the patient.
Before each exam, it is 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 crosscontamination (from patient to patient) and prevent the possibility
of inflammations or other types of reactions of the skin caused by contact with the material that constitutes the
cone.

2.2.1. OPTIONAL ACCESSORIES

►SECOND CONTROL BUTTON

►x-mind dc LIGHT
(Rx signalling lamp for external use)

►x-mind dc ECB
(remote control button)

2.3. IDENTIFICATION TAGS

The identification tags on the tubehead, on the timer and on the cone indicate the model number, the serial
number, the manufacturing date and the main technical characteristics.

2.3.1. TUBEHEAD

Model 230 V

Model: x-mind ® dc 0477

de Götzen® S.r.l.
Via Roma 45 - 21057 Olgiate Olona (VA) – ITALY

70kVp 8mA Total filtration: 2,4mm Al / 70kV 0.7mm

Nominal voltage: 230V ~ 50/60Hz Class I
X-ray tube: TOSHIBA DG-073B-DC
SN SN tube:

Model 115 V

Model: x-mind ® dc 0477

de Götzen® S.r.l.
Via Roma 45 - 21057 Olgiate Olona (VA) – ITALY

70kVp 8mA Total filtration: 2,4mm Al / 70kV 0.7mm

Nominal voltage: 115V ~ 50/60Hz Class I
X-ray tube: TOSHIBA DG-073B-DC
SN SN tube:

OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D Page 15 of 61

 ENGLISH

2.3.2. TIMER

Model 230 V

Model: x-mind ® dc
® 0477
de Götzen S.r.l.
Via Roma 45 - 21057 Olgiate Olona (VA) – ITALY

Rated line voltage: 230V ~ 50/60Hz Class I

Absorbed power: 1,20kVA IP20
SN

Model 115 V

Model: x-mind ® dc
® 0477
de Götzen S.r.l.
Via Roma 45 - 21057 Olgiate Olona (VA) – ITALY

Rated line voltage: 115V ~ 50/60Hz Class I

Absorbed power: 1,10kVA IP20
SN

CONE

GRADUATED SCALE

Page 16 of 61 OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D

 ENGLISH

PICTOGRAMS USED

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

INSTRUCTIONS IN ELECTRONIC FORMAT

REFER TO MANUAL’S INSTRUCTIONS

WEEE (Waste Electrical and Electronic Equipment) SYMBOL, IN CONFORMITY WITH 2012/19/
CE DIRECTIVE AND EN 50419 STANDARD.

OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D Page 17 of 61

 ENGLISH

CHAPTER 3
3.1. CONFIGURATION

The “x-mind dc” radiographic system is provided in the “standard mode” configuration.

On the control panel the LED relevant to the following exposure parameters will light up:

No. of the selected tubehead

LED 1

supplied cone
LED 8” = SHORT CONE
LED 12” = LONG CONE

Type of tubehead
LED DC = DIRECT CURRENT

radiographic voltage
LED 70kV

radiographic current
LED 8mA

type of patient
LED ADULT

radiographic technique
CONVENTIONAL LED D

The following exposure times (s) have been stored:

0,020 – 0,025 – 0,032 – 0,040 – 0,050 – 0,063 – 0,080 – 0,100 –0,125 – 0,160 – 0,200 – 0,250 – 0,320 – 0,400 – 0,500
– 0,630 – 0,800 – 1,00 – 1,250 – 1,600 – 2,000 – 2,500 – 3,200

PLEASE NOTE

These times are in compliance with current CEI EN 60601-1: 2007 standard and with the ISO 497 series R’10 recommendations.
THEY CANNOT BE MODIFIED

Page 18 of 61 OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D

 ENGLISH

Certain exposure values which depend on the selection of the operating parameters have been predefined:

►cone (8”/12”)
►type of patient (ADULT/CHILD)
►radiographic tecnique
►intra-oral test

PLEASE NOTE

These values have to be considered as “recommended”: it is possible to change these values if necessary. (refer to Charter 5 and 6)

To modify these exposure values

►radiographic voltage (60kV/70kV)

►radiographic current (4mA/8mA)
►type of patient (ADULT/CHILD)
►radiographic tecnique
(refer to Chapter 4)

To modify these exposure values

►cone (8” /12”)

►type tubehead
►N° of control button
change the dip-switch position, inside the timer

THIS OPERATION MUST BE CARRIED OUT BY THE INSTALLER ONLY

OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D Page 19 of 61

 ENGLISH

CHAPTER 4
4.1. INSTRUCTIONS FOR USE

1° - TURN ON

Bring the main switch located on the upper part of the timer to the “I” position (ON)

Bring the key switch to the “I” position (ON)

1. the green light turns on, indicating that the system is powered
2. the LEDs of the set parameters automatically light up
3. the exposure time is shown on the display

CAUTION

If an error is detected when the system is turned on, the anomaly is indicated as follows:
- emission of an intermittent acoustic signal (beep)
- MALFUNCTIONING INDICATOR LED
intermittently turns on
- the error code (E ….) appears on the display (refer to Chapter 8)
- all control panel functions are inhibited
In this case turn off the timer and then turn it back on.
If the error persists, call the “Assistance Service”.

PLEASE NOTE

The exposure time and parameters which appear on the display are the last that were set before the timer was turned off.
If the timer remains inactive for a few minutes, it switches to the stand-by mode.
Press any key on the control panel to restore it to the operative mode.

Page 20 of 61 OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D

 ENGLISH

2° - CHECK THE SELECTED PARAMETER

Before making the exposure, check that the parameter selected on the control panel (from Step 1 to Step 8) are
suitable for the radiographic exam.

STEP 1 : check the selected tubehead

The LED of the desired tubehead should be turned on

LED Rx 1 ON
indicates that the tubehead connected to the timer X-ray1 terminal block is selected

LED Rx 2 ON
indicates that the tubehead connected to the timer X-ray2 terminal block is selected

to change the selection press again the button

STEP 2 : check the selected radiographic distance CONE

The LED of the cone length (source-skin distance = SSD) in use should be turned on

LED 8” ON
indicates that the selected tubehead is equipped with 8” = 20cm (SSD) cone

LED 12” ON
indicates that the selected tubehead is equipped with 12” = 31cm (SSD) cone

to change the selection call the “Assistance Service”

PLEASE NOTE

After the modification, default exposure values will be automatically changed.

STEP 3 : check the selected type of tubehead

The LED of the type of selected tubehead should be turned on

LED AC ON
indicates that the selected tubehead works in alternate current technology

LED DC ON
indicates that the selected tubehead works in direct current technology

It is not possible to change the selection: an dc device has to be used only in combination with an dc tubehead

OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D Page 21 of 61

 ENGLISH

STEP 4 : check the selected radiographic voltage

The LED of the radiographic voltage should be turned on

LED 60kV ON
indicates that the radiographic system is set with the high contrast radiodiagnostic technology

LED 70kV ON
indicates that the radiographic system is set with the low contrast radiodiagnostic technology

to change the selection press again the button

PLEASE NOTE

60kV mode can be selected with the “x-mind dc” radiographic system only.

PLEASE NOTE

After the modification, default exposure values will be automatically changed.

STEP 5 : check the selected radiographic current

The LED of the radiographic current should be turned on

LED 4mA ON
indicates that the radiographic system is set with reduced dose.
It is advisable the use of digital radiographic technique.

LED 8mA ON
indicates that the radiographic system is set with nominal dose.
It is advisable the use of conventional radiographic technique.

to change the selection press again the button

PLEASE NOTE

The 4mA mode can be selected with the “x-mind dc” radiographic system only.

PLEASE NOTE

After the modification, default exposure values will be automatically changed.

Page 22 of 61 OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D

 ENGLISH

STEP 6 : check the selected type of patient

The LED of the desired type of patient should be turned on

LED CHILD ON
indicates that the radiographic system is set for a patient with a small physique

LED ADULT ON
indicates that the radiographic system is set for a patient with a large physique

to change the selection press again the button

PLEASE NOTE

After the modification, default exposure values will be automatically changed.

STEP 7 : check the selected radiographic technique

CONVENTIONAL TECHNIQUE (FILM)

The LED of the desired speed film should be turned on

LED D ON
radiographic system is set for use with D speed film

LED E ON
radiographic system is set for use with E speed film

LED F ON
radiographic system is set for use with F speed film

to change the selection press the button for 3 s: an acoustic signal (beep) will confirm the change

PLEASE NOTE

With films it is advisable to use a radiographic current of 8 mA (refer to STEP 5)

PLEASE NOTE

After the modification, default exposure values will be automatically changed.

OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D Page 23 of 61

 ENGLISH

DIGITAL TECHNIQUE (SENSOR)

The LED should be turned on

to change the selection press the button for 3 s: an acoustic signal (beep) will confirm the change

PLEASE NOTE

With films it is advisable to use a radiographic current of 4mA (refer to STEP 5)

PLEASE NOTE

After the modification, default exposure values will be automatically changed.

STEP 8 : check the selected radiographic technique

PERIAPICAL EXAM

The LED of the selected teeth should be turned on

to change the selection press the key relative to the desired tooth

OCCLUSAL EXAM

The LED of the selected type of test should be turned on

LED MANDIBULA ON
radiographic system is set for occlusal exam of the lower jaw

LED MAXILLA ON
radiographic system is set for occlusal exam of the upper jaw

to change the selection press again the button

Page 24 of 61 OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D

 ENGLISH

BITE-WING EXAM

The LED of the selected type of test should be turned on

LED ANT ON
radiographic system is set for anterior bite-wing exam

LED POST ON
radiographic system is set for posterior bite-wing exam

to change the selection press the key relative to the desired exam

3° - POSITIONING THE PATIENT

Position the patient following the standard intraoral procedures.

4° - POSITIONING FILM or SENSOR

Position either the film or the digital sensor depending on the technique to be used.

5° - POSITIONING CONE
Follow the standard intra-oral procedures to position the cone.

6° - CHECK ON THE DISPLAY THE SELECTED TIME

Before proceeding with the exposure, check on the display the selected time

to change the selection press the following keys

! WARNING

This modification brought to the exposure time is momentary and it will be lost unless it is saved. (refer to Chapter 6) To restore the pre-
vious values, press one of the keys with the LED turned off on the control panel.

7° - MAKE THE EXPOSURE

1. Take the control button of the timer relevant to the selected tubehead and keep a safety distance (at least 2
meters) from the tubehead, in order to be able to constantly check the radiographic exposure

2. Advise the patient to remain still

3. On the control button press the X-ray key and keep it pressed until the acoustic signal (beep) stops

and LED yellow turns off

OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D Page 25 of 61

 ENGLISH

PLEASE NOTE

If the “X-ray” key is released earlier than the selected exposition time, the exposure is immediately interrupted and the E12 error message
appears on the display.

4. At the end of the exposure, the green LED PAUSE intermittently turns on

5. The display indicates the actual exposure time

6. All the timer functions are inhibited

PLEASE NOTE

The pause time is necessary to allow the X-ray tube to cool down.
This time is calculated by the microprocessor, depending on the exposure time, with a ratio of 1:32 (32 s of pause are required for each
second of exposure)

A NEW EXPOSURE WILL BE POSSIBLE AFTER THE GREEN LED HAS TURNED OFF

REPEAT THE OPERATIVE SEQUENCE FROM POINT 2 TO POINT 7 TO MAKE A NEW EXPOSURE

Page 26 of 61 OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D

 ENGLISH

CHAPTER 5
5.1. CHART OF DEFAULT EXPOSURE VALUES

The chart indicates the “x-mind dc” radiographic system predefined exposure values. (refer to Chapter 3)

I INCISOR
C CANINE
P PREMOLAR
M MOLAR
Ba ANTERIOR BITE-WING
Bp POSTERIOR BITE-WING
Oa OCCLUSAL ANTERIOR
Op OCCLUSAL POSTERIOR

PLEASE NOTE

The default exposure times can be modified. (refer to Chapter 6)

PLEASE NOTE

The following exposure values are only indicative and the manufacturer cannot guarantee the universal applicability of them for any kind of
circumstances or type of X-ray sensor used, since variations and inaccuracies may arise from sensor to sensor and may require adjustments to
accommodate local configurations (software, film processing, digital processing, CCD or CMOS types, etc.)
Therefore the operator must establish for each of support used and for each patient the correct technique factors (kV, mA, s) setting needed.
The operator has the full responsibility to determine and implement the correct technique factors required in accordance with the type of
X-ray examination being performed.
Before performing an intraoral radiograph by any Digital X-ray sensor (CMOS or CCD) or Phosphor Plates (PSP), the operator must imperatively
verify and eventually adjust the pre-programmed exposure time setting of the “x-mind dc” using the instructions contained in the accompa-
nying document of the sensor.

PLEASE NOTE

When selecting the kV follow this general rule:

Lower kV – high contrast images useful for endodontic diagnosis, apex and bone structures.
Higher kV – wider gray scale. Useful for diagnosis of periodontal pathologies.

! WARNING

In radiation physics the X-ray beam intensity is measured in terms of air kerma (mGy), the unit that indicates the amount of radiation in an
X-ray beam.
The X-ray beam intensity is proportional to the X-ray tube current (mA): doubling the tube current will double the X-ray beam intensity.
The X-ray beam intensity is proportional to the exposure time (s): doubling the exposure time will double the X-ray beam intensity.

OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D Page 27 of 61

 ENGLISH

12” LONG CONE (SSD = 31cm)

CONVENTIONAL RADIOGRAPHIC TECHNIQUE (FILM)

ADULT

PROGRAMMED
EXPOSURE TIMES
0,020

0,025

0,032

0,040

0,050

0,063

0,080

0,100

0,125

0,160

0,200

0,250

0,320

0,400

0,500

0,630

0,800

1,000

1,250

1,600

2,000

2,500

3,200
(sec)

70kV - 8mA

CP
MAXILLA I M Op
FILM Bp
D CP
MANDIBLE I M - Oa
Ba

CP
MAXILLA I M Op
Bp
FILM
E C
MANDIBLE I P M - Oa
Ba

C
MAXILLA I P M Op
FILM Bp
F C
MANDIBLE I P M - Oa
Ba

ADULT

PROGRAMMED
EXPOSURE TIMES
0,020

0,025

0,032

0,040

0,050

0,063

0,080

0,100

0,125

0,160

0,200

0,250

0,320

0,400

0,500

0,630

0,800

1,000

1,250

1,600

2,000

2,500

3,200

(sec)

60kV - 8mA

CP
MAXILLA I M Op
FILM Bp
D CP
MANDIBLE I M - Oa
Ba

C
MAXILLA I P M Op
FILM Bp
E
CP
MANDIBLE I M - Oa
Ba

CP
MAXILLA I M Op
Bp
FILM
F C
MANDIBLE I P M - Oa
Ba

Page 28 of 61 OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D

 ENGLISH

CHILD

PROGRAMMED
EXPOSURE TIMES
0,020

0,025

0,032

0,040

0,050

0,063

0,080

0,100

0,125

0,160

0,200

0,250

0,320

0,400

0,500

0,630

0,800

1,000

1,250

1,600

2,000

2,500

3,200
(sec)

70kV - 8mA

CP
MAXILLA I M Op
FILM Bp
D CP
MANDIBLE I M - Oa
Ba

C
MAXILLA I P M Op
FILM Bp
E
CP
MANDIBLE I M - Oa
Ba

CP
MAXILLA I M Op
FILM Bp
F CP
MANDIBLE I M - Oa
Ba

CHILD

PROGRAMMED
EXPOSURE TIMES
0,020

0,025

0,032

0,040

0,050

0,063

0,080

0,100

0,125

0,160

0,200

0,250

0,320

0,400

0,500

0,630

0,800

1,000

1,250

1,600

2,000

2,500

3,200
(sec)

60kV - 8mA

CP
MAXILLA I M Op
FILM Bp
D CP
MANDIBLE I M - Oa
Ba

CP
MAXILLA I M Op
Bp
FILM
E C
MANDIBLE I P M - Oa
Ba

C
MAXILLA I P M Op
FILM Bp
F C
MANDIBLE I P M - Oa
Ba

OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D Page 29 of 61

 D
D
D
D

(sec)
(sec)
(sec)
(sec)

FILM
FILM
FILM
FILM

60kV - 4mA
70kV - 4mA
60kV - 4mA
70kV - 4mA

PROGRAMMED
PROGRAMMED
PROGRAMMED
PROGRAMMED

MAXILLA
MAXILLA
MAXILLA
MAXILLA

MANDIBLE
MANDIBLE
MANDIBLE
MANDIBLE

EXPOSURE TIMES
EXPOSURE TIMES
EXPOSURE TIMES
EXPOSURE TIMES

Page 30 of 61
0,020 0,020 0,020 0,020

0,025 0,025 0,025 0,025

0,032 0,032 0,032 0,032

I
0,040 0,040 0,040 0,040

I
I

Ba
0,050 0,050 0,050

CP
0,050

Ba

M
0,063 0,063

CP
0,063

Bp
CP
0,063

I
-
M
0,080 0,080

M
Bp
CP
0,080 0,080

I
I
-

Ba
0,100

CP
0,100
M

Oa
0,100

Op
0,100

I
DIGITAL RADIOGRAPHIC TECHNIQUE (SENSOR)

P
C
Ba

M
CP

Bp
0,125 0,125
Oa
Op

0,125 0,125

-
M

M
Bp
CP
0,160 0,160 0,160 0,160

-
M

Oa
Op
0,200 0,200 0,200 0,200

CHILD
CHILD
ADULT

ADULT

Oa
Op
0,250 0,250 0,250 0,250

0,320 0,320 0,320 0,320

0,400 0,400 0,400 0,400

ENGLISH

0,500 0,500 0,500 0,500

0,630 0,630 0,630 0,630

OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D

0,800 0,800 0,800 0,800

1,000 1,000 1,000 1,000

1,250 1,250 1,250 1,250

1,600 1,600 1,600 1,600

2,000 2,000 2,000 2,000

2,500 2,500 2,500 2,500

3,200 3,200 3,200 3,200

 ENGLISH

8” SHORT CONE (SSD = 20cm)

CONVENTIONAL RADIOGRAPHIC TECHNIQUE (FILM)

ADULT

PROGRAMMED
EXPOSURE TIMES
0,020

0,025

0,032

0,040

0,050

0,063

0,080

0,100

0,125

0,160

0,200

0,250

0,320

0,400

0,500

0,630

0,800

1,000

1,250

1,600

2,000

2,500

3,200
(sec)

70kV - 8mA

CP
MAXILLA I M Op
FILM Bp
D CP
MANDIBLE I M - Oa
Ba

C
MAXILLA I P M Op
FILM Bp
E
CP
MANDIBLE I M - Oa
Ba

CP
MAXILLA I M Op
FILM Bp
F CP
MANDIBLE I M - Oa
Ba

ADULT

PROGRAMMED
EXPOSURE TIMES
0,020

0,025

0,032

0,040

0,050

0,063

0,080

0,100

0,125

0,160

0,200

0,250

0,320

0,400

0,500

0,630

0,800

1,000

1,250

1,600

2,000

2,500

3,200

(sec)

60kV - 8mA

CP
MAXILLA I M Op
FILM Bp
D CP
MANDIBLE I M - Oa
Ba

CP
MAXILLA I M Op
FILM Bp
E CP
MANDIBLE I M - Oa
Ba

CP
MAXILLA I M Op
FILM Bp
F CP
MANDIBLE I M - Oa
Ba

OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D Page 31 of 61

 ENGLISH

CHILD

PROGRAMMED
EXPOSURE TIMES
0,020

0,025

0,032

0,040

0,050

0,063

0,080

0,100

0,125

0,160

0,200

0,250

0,320

0,400

0,500

0,630

0,800

1,000

1,250

1,600

2,000

2,500

3,200
(sec)

70kV - 8mA

CP
MAXILLA I M Op
FILM Bp
D CP
MANDIBLE I M - Oa
Ba

C
MAXILLA I P M Op
FILM Bp
E C
MANDIBLE I P M - Oa
Ba

C
MAXILLA I P M Op
FILM Bp
F
CP
MANDIBLE I M - Oa
Ba

CHILD

PROGRAMMED
EXPOSURE TIMES
0,020

0,025

0,032

0,040

0,050

0,063

0,080

0,100

0,125

0,160

0,200

0,250

0,320

0,400

0,500

0,630

0,800

1,000

1,250

1,600

2,000

2,500

3,200
(sec)

60kV - 8mA

CP
MAXILLA I M Op
FILM Bp
D CP
MANDIBLE I M - Oa
Ba

CP
MAXILLA I M Op
FILM Bp
E CP
MANDIBLE I M - Oa
Ba

CP
MAXILLA I M Op
Bp
FILM
F C
MANDIBLE I P M - Oa
Ba

Page 32 of 61 OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D

 D
D
D
D

(sec)
(sec)
(sec)
(sec)

FILM
FILM
FILM
FILM

60kV - 4mA
70kV - 4mA
60kV - 4mA
70kV - 4mA

PROGRAMMED
PROGRAMMED
PROGRAMMED
PROGRAMMED

MAXILLA
MAXILLA
MAXILLA
MAXILLA

MANDIBLE
MANDIBLE
MANDIBLE
MANDIBLE

EXPOSURE TIMES
EXPOSURE TIMES
EXPOSURE TIMES
EXPOSURE TIMES

I
0,020 0,020 0,020 0,020

I
I

Ba
0,025 0,025 0,025

CP
0,025

Ba

M
0,032 0,032

CP
0,032

Bp
CP
0,032

I
-
M
0,040 0,040

Bp

M
CP
0,040 0,040

I
I

Ba
-
0,050

CP
0,050

Oa
Op
0,050 0,050

Ba

M
CP
0,063

Bp
CP
0,063

Oa
Op
0,063 0,063

-
Bp
CP

M
0,080 0,080
0,080 0,080

-
M
0,100

Oa
Op
0,100
DIGITAL RADIOGRAPHIC TECHNIQUE (SENSOR)

0,100 0,100

Oa
Op
0,125 0,125 0,125 0,125

0,160 0,160 0,160 0,160

0,200 0,200 0,200 0,200

CHILD
CHILD
ADULT
ADULT

0,250 0,250 0,250 0,250

0,320 0,320 0,320 0,320

0,400 0,400 0,400 0,400

ENGLISH

0,500 0,500 0,500 0,500

0,630 0,630 0,630 0,630

0,800 0,800 0,800 0,800

1,000 1,000 1,000 1,000

1,250 1,250 1,250 1,250

1,600 1,600 1,600 1,600

OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D

2,000 2,000 2,000 2,000

2,500 2,500 2,500 2,500

3,200 3,200 3,200 3,200

Page 33 of 61
 ENGLISH

CHAPTER 6
6.1. PROGRAMMING DEFAULT EXPOSURE VALUES

! WARNING

The 23 programmed exposure times cannot be modified in the “x-mind dc” radiographic sys-
tem, since they are defined in conformity with the regulation in force concerning X-ray intra-
oral equipment.
Meanwhile it is possible to customize the default exposure values. (refer to Chapter 3)

! WARNING

After customizing, the “Chart of default exposure values” (refer to Chapter 5) are not valid
any more.

To program the new exposure values press the following keys

PLEASE NOTE

The “repeat” function automatically sets in when the key is kept pressed, so the time shown
on the display scrolls faster.

To confirm the new program check the LED key

LED MEMO ON
indicates that it is possible to save the new default exposure value.
Press the button for 3s until the acoustic signal confirms the new default exposure values have been saved.

LED MEMO OFF

indicates that it is not possible to save the new default exposure value

PLEASE NOTE

It is not possible to save data when the “range of exposure field” exceeds the programmed
exposure time limits. (refer to the example in the next page)

Page 34 of 61 OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D

 ENGLISH

EXAMPLE

12” LONG CONE (SSD = 31cm) - CONVENTIONAL RADIOGRAPHIC TECHNIQUE (FILM)

PREDEFINED DEFAULT EXPOSURE VALUES

ADULT

PROGRAMMED
EXPOSURE TIMES
0,020

0,025

0,032

0,040

0,050

0,063

0,080

0,100

0,125

0,160

0,200

0,250

0,320

0,400

0,500

0,630

0,800

1,000

1,250

1,600

2,000

2,500

3,200
(sec)

70kV - 8mA

CP
MAXILLA I M Op
FILM Bp
D CP
MANDIBLE I M - Oa
Ba

CP
MAXILLA I M Op
FILM Bp
E CP
MANDIBLE I M - Oa
Ba

CP
MAXILLA I M Op
FILM Bp
F CP
MANDIBLE I M - Oa
Ba

CUSTOMISED EXPOSURE VALUES

THE RANGE OF EXPOSURE FIELD HAS BEEN REDUCED BY TWO STEPS

CP
I M Op
Bp
CP
I M - Oa
Ba

ADULT

PROGRAMMED
EXPOSURE TIMES
0,020

0,025

0,032

0,040

0,050

0,063

0,080

0,100

0,125

0,160

0,200

0,250

0,320

0,400

0,500

0,630

0,800

1,000

1,250

1,600

2,000

2,500

3,200

(sec)

70kV - 8mA

CP
MAXILLA I M Op
FILM Bp
D CP
MANDIBLE I M - Oa
Ba

CP
MAXILLA I M Op
FILM Bp
E CP
MANDIBLE I M - Oa
Ba

CP
MAXILLA I M Op
FILM Bp
F CP
MANDIBLE I M - Oa
Ba

OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D Page 35 of 61

 ENGLISH

6.2. RESTORING ORIGINAL VALUES

1 . Turn off the timer

2. Turn the timer on keeping the key pressed OFF

3 . “OFF” appears on the display

4. Release the key

5. Press again the key ON

6 . “ON” appears on the display

7 . Turn off and on the timer

Page 36 of 61 OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D

 ENGLISH

CHAPTER 7
7.1. DIAGNOSTIC

With “x-mind dc” radiographic system it is possible to visualise certain functional parameters.

To visualise them proceed as follows:

1. press simultaneously and keep pressed the keys

(17) MAXILLA MOLAR

(47) MANDIBULARY MOLAR

2. press the key associated to the parameter to visualise

KEY DISPLAY PARAMETER

RADIOGRAPHIC SYSTEM
NOMINAL VOLTAGE

LINE VOLTAGE

SOFTWARE VERSION

OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D Page 37 of 61

 ENGLISH

CHAPTER 8
8.1. ERROR MESSAGES

The following chart gives a list of error messages that may appear while “x-mind dc” radiographic system is
working.
The chart also includes the causes of the error messages and what to do to solve them.

ERROR
CAUSE SOLUTION
MESSAGES
RX1 TUBEHEAD
E00 CALL THE “ASSISTANCE SERVICE”
IS NOT CONNECTED OR IS OUT OF ORDER
RX2 TUBEHEAD
E01 CALL THE “ASSISTANCE SERVICE”
IS NOT CONNECTED OR IS OUT OF ORDER
E02 CORRUPTED EEPROM DATA CALL THE “ASSISTANCE SERVICE”
E03 EEPROM DATA NOT SAVED PROPERLY CALL THE “ASSISTANCE SERVICE”
LINE VOLTAGE VALUE NOT INCLUDED
E07 CALL THE “ASSISTANCE SERVICE”
WITHIN THE ±10% NOMINAL VALUE
THE X-ray KEY
E08 MAKE SURE IT IS NOT JAMMED
ALWAYS SEEMS TO BE PRESSED
E09 ANOMALY IN THE CONTROL PANEL CALL THE “ASSISTANCE SERVICE”
THE EXPOSURE KEEP THE X-ray KEY
E12
HAS BEEN PREMATURELY INTERRUPTED PRESSED TILL THE END OF THE EXPOSURE
E20 ANOMALY IN THE TRIAC/RELAY CALL THE “ASSISTANCE SERVICE”
E21 ANOMALY IN THE ELECTRONIC CIRCUIT CALL THE “ASSISTANCE SERVICE”
E23 INCORRECT DIP-SWITCH CONFIGURATION CALL THE “ASSISTANCE SERVICE”
THE CONTROL BUTTON DOES NOT CORRESPOND
E24 CALL THE “ASSISTANCE SERVICE”
TO THE SELECTED TUBEHEAD
THE TUBEHEAD
E30 CALL THE “ASSISTANCE SERVICE”
DOES NOT WORK PROPERLY
THE TUBEHEAD
E32 CALL THE “ASSISTANCE SERVICE”
IS NOT IN THE CORRECT MODE
THE TUBEHEAD REPEAT THE EXPOSURE
E33
HAS NOT COMPLETED THE EXPOSURE CALL THE “ASSISTANCE SERVICE”
PROBLEM IN THE FREQUENCY
E40 CALL THE “ASSISTANCE SERVICE”
OR REGULATION
THE TUBEHEAD CARRY OUT WITH THE CALIBRATION
E41
IS NOT CALIBRATED CALL THE “ASSISTANCE SERVICE”
E42 EEPROM DATA NOT SAVED PROPERLY CALL THE “ASSISTANCE SERVICE”
E43 CORRUPTED EEPROM DATA CALL THE “ASSISTANCE SERVICE”
E44 OVERVOLTAGE ERROR CALL THE “ASSISTANCE SERVICE”
E45 ANODE VOLTAGE OUT OF TOLERANCE CALL THE “ASSISTANCE SERVICE”

Page 38 of 61 OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D

 ENGLISH

E46 ANODE CURRENT OUT OF TOLERANCE CALL THE “ASSISTANCE SERVICE”

E47 CONTROL CONNECTOR CALL THE “ASSISTANCE SERVICE”
E48 PROBLEM IN THE REFERENCE VOLTAGE CALL THE “ASSISTANCE SERVICE”
ALL FUNCTIONS ARE DISABLED
ERR MAJOR ERROR
CALL THE “ASSISTANCE SERVICE”

OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D Page 39 of 61

 ENGLISH

CHAPTER 9
9.1. VERIFICATION OF THE EXPOSURE FACTORS

In order to guarantee safety of the radiographic system, it is necessary to set up a periodic control schedule of
the exposure factors.
The RESPONSIBLE ORGANIZATION is required to organise and observe a control schedule of the exposure factors
as detailed in this chapter.
All the following controls must be performed every 12 months.

CAUTION

During these procedures X-rays will be emitted. Please take every necessary precautions in order to avoid accidental exposure to ionizing radia-
tions.

STEP 1 – Checking the radiographic voltage (kVp)

The radiographic voltage is measured using a calibrated “non invasive” instrument.

SET TECHNICAL FACTORS

Vn ± 10% NOMINAL VOLTAGE
3% MAXIMUM VOLTAGE DROP
60 / 70 kV NOMINAL HIGH VOLTAGE
4 / 8 mA NOMINAL CURRENT
3,2 s SET EXPOSURE TIME

The radiographic voltage is is 60kVp / 70kVp ±10%.

STEP 2 – Dose verification (mGy)

The dose in air is measured with a “non invasive” instrument, by positioning the detector at a source-skin distance
= 31cm (12”) (SSD) or 20cm (8”) (SSD).

SET TECHNICAL FACTORS

Vn ± 10% NOMINAL VOLTAGE
3% MAXIMUM VOLTAGE DROP
60 / 70 kV NOMINAL HIGH VOLTAGE
4 / 8 mA NOMINAL CURRENT
1s SET EXPOSURE TIME

Page 40 of 61 OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D

 ENGLISH

Dose in air is:

SOURCE-SKIN DISTANCE

31 cm = 12” 20 cm = 8”
60 kV – 4 mA = 2,2 mGy/s ± 30% 60 kV – 4 mA = 4,5 mGy/s ± 30%
70 kV – 4 mA = 3 mGy/s ± 30% 70 kV – 4 mA = 6 mGy/s ± 30%
60 kV – 8 mA = 4,5 mGy/s ± 30% 60 kV – 8 mA = 9 mGy/s ± 30%
70 kV – 8 mA = 5,5 mGy/s ± 30% 60 kV – 4 mA = 12 mGy/s ± 30%

STEP 3 – Checking the exposure time (s)

The exposure time is measured with a “non invasive” instrument.

SET TECHNICAL FACTORS

Vn ± 10% NOMINAL VOLTAGE
3% MAXIMUM VOLTAGE DROP
60 / 70 kV NOMINAL HIGH VOLTAGE
4 / 8 mA NOMINAL CURRENT
3,2 s SET EXPOSURE TIME

The exposure time measured is 3,2s ±5% or ±20 ms, whichever is larger.

OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D Page 41 of 61

 ENGLISH

CHAPTER 10
10.1. SUGGESTED MAINTENANCE

In order to guarantee safety of the radiographic system, it is necessary to set up a maintenance schedule.
The RESPONSIBLE ORGANISATION is responsible for planning and observing a maintenance schedule which
must be executed by qualified technicians who must be able to certify their work with a “Conformity Declaration”.

CAUTION

Run an inspection on the radiographic system and on its operation when it is installed and every twelve months.

Once a year, lubricate the pins and bushes of the wall plate and the positioning arm, as specified in the
INSTALLATION & MAINTENANCE MANUAL.

! WARNING

Do not lose the adjustment key that comes with the system, since, in time, it could become
necessary to make readjustments.

! WARNING

If the parts should become hard to move or should squeak, call the “Assistance Service”.

10.2. CLEANING THE OUTER SURFACES

Clean the external surface using a damp cloth and non-corrosive non oil-based detergent and disinfect it using a
non-aggressive medical detergent.
Do not spray detergent or disinfectant directly on the device.
The spacer cone may be cleaned with cotton wool soaked with surgical alcohol.

CAUTION

• Turn off and disconnect the device from the supply mains before carrying out cleaning operations.
• Do not spray products directly on the device. Apply the product on a clean cloth.
• Always use disposable protective covers for the applied parts.
• Do not use UV systems to disinfect the equipment, as exposed parts of the device can turn yellow or discolour.
• To avoid any potential hazard or danger to operators and patients, contact your authorized Acteon Technical Representative immediately if you
experience any unusual operation, mechanical issues, or equipment malfunction.

Page 42 of 61 OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D

 ENGLISH

CAUTION

• To ensure both the patient’s and operator’s safety as well as preserving a high image quality, the device must always be well maintained as
described in the accompanying documents. For other maintenance operations, refer to the installation and maintenance manual.

• The RESPONSIBLE ORGANIZATION of the device is responsible for scheduling and having preventive maintenance carried out at least every 12
(twelve) months, which consists of maintenance carried out by qualified, authorized professional technicians. It is the RESPONSIBLE ORGANIZA-
TIONS’s responsibility to arrange for this service and to assure that the personnel performing this function are fully qualified to service “x-mind
dc” X-ray equipment.

• 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 dc”X-ray System and as part of the recommended maintenance as indi-
cated in the accompanying documents. Failure to perform these checks may result in an installation that does not comply with U.S. Radiation
Performance Standards 21 CFR Subchapter J.

• The manufacturer shall not be held liable for damage or injuries caused by failure to carry out inspections and tests and by incomplete mainte-
nance.

• Repairs and replacements of any component must be carried out solely by authorized and highly qualified personnel and only using genuine
spare parts supplied by de Götzen® S.r.l.

• Do not operate the unit if there is the threat of an earthquake. Following an earthquake, ensure that the unit is operating properly. It’s manda-
tory to thoroughly check all functions and safety aspects before resuming use.

OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D Page 43 of 61

 ENGLISH

CHAPTER 11
11.1. REPAIR

In case of a malfunction, send the defective part using the original packaging to:

de Götzen® S.r.l.
Via Roma 45
21057 OLGIATE OLONA VA ITALY

Tel. +39 0331 376760

Fax +39 0331 376763
E-mail: [email protected]

CAUTION

It is strictly prohibited to attempt repairs to any electronic or mechanical parts by yourself.

Failure to observe this warning can irreversibly compromise the overall safety of the system and can be dangerous for operators, patients and
the environment.

11.2. DISPOSAL

The use of the WEEE symbol indicates that, at the end of its lifespan, this product may not be treated as
household waste, but must be treated separately, in conformity to the Directive 2012/19/EC.
EU Council Directive 2012/19/EC (WEEE) imposes the disposal or recycling of electric and electronic equip-
ment. The product is marked with the indicated icon. This product must not be disposed of as domestic waste.
The crossed-out wheelie bin identifies a product placed on the market after the 13th of August 2005 (see EN
50419:2006). This product is subjected to Council Directive 2012/19/EU (WEEE) and implementation standards
in force in your country.
The product must be disposed of or recycled to protect the environment.
Contact your supplier before disposing of this product.

CAUTION

To avoid any risk of environmental contamination, do not dispose the device and its accessories together with the domestic waste.

Page 44 of 61 OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D

 ENGLISH

ANNEX 1
A1. TECHNICAL SPECIFICATIONS

X-ray SOURCE ASSEMBLY

Half Value Layer (HVL) at 70 kV 2,2 mm Al

Total filtration at 70 kV 2,4 mm Al
Tube inherent filtration at 70 kV > 1 mm Al
X-ray tube tension accuracy ±10%
X-ray tube current accuracy ±20%
Radiation linearity ±10%
±20 ms 0,020 s ≤ t ≤ 0,320 s
X-ray emission time accuracy
±5% 0,400 s ≤ t ≤ 3,2 s
Reproducibility 0,05
Generator At constant potential
X-ray tube nominal current 4 mA / 8 mA
X-ray tube nominal voltage 60 / 70 kV
Exposure times 0,020 s ÷ 3,2 s (23 steps)
0,8 mAs 8 mA 0,1 s
Reference current-time product
0,4 mAs 4 mA 0,1 s
Intensity of radiation in the air > 30 μGy/h at 1 m from focal spot
Leakage radiation (measured @ 70kV, 8 mA, 3,2 s) < 0,25 mGy/h at 1 m from focal spot
Operating cycle 1:32
Loading factors related to the maximum specified energy input
70kV – 8mA – 3,2 s
in one hour
Tube anode rating charts according to
TOSHIBA DG-073BDC official datasheet and
maximum rated values 70 kV, 8 mA, 3,2 s. kV,
Tube Rating Charts
mA and s settings are used fixed, the relevant
combinations are within the maximum allowed
by the X-ray tube specifications.

PLEASE NOTE

The measurements criteria are based on the requirements stated by the applicable standards
listed in the annex A.3 of this manual.

OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D Page 45 of 61

 ENGLISH

HEATING AND COOLING CURVES

X-ray TUBE

X-ray tube model TOSHIBA DG-073-DC

Focal spot size (IEC 336) 0,7 mm
Anode angle 20°
Anod material tungsten

Heating/cooling curves of the TOSHIBA DG-073B-DC

Page 46 of 61 OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D

 ENGLISH

DEVICE POWER SUPPLY

Type of power supply single phase, alternate

230 V
Supply nominal voltage
115 V
Maximum voltage variation ±10%
5,2 A @ 230 V
Nominal current
9,5 A @ 115 V
Supply voltage frequency 50/60 Hz
Maximum line current (measured @ 70 kV, 8 mA, 3,2 s) 9,5 A @ 115V
1,2 kVA @ 230V
Absorbed power
1,1 kVA @ 115V
0,5 Ω
Apparent resistance
0,2 Ω
F 8 A – 250 V
Protection fuses (F1 – F2 – F3 – F4)
F 12,5 A – 250 V
(F5) – n° 1 630 mA – 125 V
Circuit protection fuses
(F6) – n° 1 500 mA – 125 V

ELECTRICAL CLASSIFICATION (IEC 60601-1)

Protection against electrical shock (insulation class) Class I

Degree of protection against electrical Shock (applied part) Type B (collimator cone)
Protection against harmful ingress of water or particulate matter IP 20
Not for use in presence of flammable
Use with flammable anaesthetics anaesthetic mixture with air, oxygen or
nitrous oxide.
The device is supplied not sterile and it must
Sterilization and disinfection methods
not be subjected to sterilization
Continuous operation with intermittent X-ray
Operation mode
loading

MECHANICAL DATA

19,5 kg (wall mounting)

Total weight
50 kg (mobile version)
Weight of the tubehead 5,5 kg
Mechanical configuration Wall mounting, top and bottom / Mobile

OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D Page 47 of 61

 ENGLISH

COLLIMATOR CONE TECHNICAL DATA

short cone 20 cm (8’’)

Source-skin distance (SSD) long cone 31 cm (12’’)
rectangular cone 31 cm (12’’)
short cone ≤ 60 mm
X-ray beam dimension long cone ≤ 60 mm
rectangular cone 44x35 mm

Page 48 of 61 OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D

 ENGLISH

ANNEX 2
A2. INTENDED ENVIRONMENT

CAUTION

“x-mind dc” is for INDOOR USE ONLY.

If the “x-mind dc” 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.

CLINICAL ENVIRONMENT CONDITIONS (OPERATING CONDITIONS)

• Temperature: 10 °C (50°F) ÷ 40 °C (104°F);

• Relative humidity: 25 ÷ 75 %;
• Atmospheric pressure: 850 ÷ 1060 hPa.

TRANSPORTATION ENVIROMNMENT CONDITIONS

• Temperature: 0 °C (32°F) ÷ 50 °C (122°F);

• Relative humidity: see clinical environment conditions
• Atmospheric pressure: 500 ÷ 1060 hPa

WAREHOUSE ENVIRONMENT CONDITIONS

• Temperature: -15 °C (5°F) ÷ 50 °C (122°F);

• Relative humidity: see clinical environment conditions
• Atmospheric pressure: 500 ÷ 1060 hPa

OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D Page 49 of 61

 ENGLISH

ANNEX 3
A3. LIST OF INTERNATIONAL STANDARDS AND DIRECTIVES

“x-mind dc”: 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:

CLASS IIb

• DHHS Radiation performance standards 21 CFR Subchapter J, Sec. 1020.30 and 1020.31
• CEI EN 60601-1-2: 2007, 3rd edition
• CEI EN 60601-1: 2007, 3rd edition
• CEI EN 60601-1-3: 2009
• CEI EN 60601-1-6: 2011
• IEC 60601-2-65: 2012
• ANSI/AAMI ES60601-1: 2005
• CAN/CSA-C222.2 N. 60601-1: 08

Certifications

Page 50 of 61 OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D

 ENGLISH

ANNEX 4
A4. DOSIMETRIC INDICATIONS

The radiation exposure is reported in terms of Dose Area Product (DAP), which takes into account the entire
area of the X-ray beam and the total amount of X-ray radiation incident on the patient. The DAP is obtained
by multiplying the Air Kerma by the corresponding X-ray beam area, which is dependent by the typology of
beam limiting device installed. It is independent by the measured location, because increases in beam area are
compensated by the reduction of beam intensity (inverse square law).
The dosimetric values reported here are relevant to the following measured values of Total Filtration and Half
Value Layer (HVL):

kV HVL (mm Al) Total Filtration (mm Al)

60 1,9 2,4
70 2,2 2,4

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).
As per paragraph 203.6.4.5 of the IEC 60601- 2-65, the overall deviation from the estimated air kerma is within
50%.

BLD Shape Circular

SSD (mm) 310
kV 60 70
mA 4 8 4 8
Time (s) DAP (mGy*cm2)
0,02 0,932588 1,865177 1,192094 2,384188
0,025 1,165736 2,331471 1,490118 2,980235
0,032 1,492142 2,984283 1,907351 3,814701
0,04 1,865177 3,730354 2,384188 4,768376
0,05 2,331471 4,662942 2,980235 5,960471
0,063 2,937654 5,875308 3,755096 7,510193
0,08 3,730354 7,460708 4,768376 9,536753
0,1 4,662942 9,325885 5,960471 11,92094
0,125 5,828678 11,65736 7,450588 14,90118
0,16 7,460708 14,92142 9,536753 19,07351
0,2 9,325885 18,65177 11,92094 23,84188
0,25 11,65736 23,31471 14,90118 29,80235
0,32 14,92142 29,84283 19,07351 38,14701
0,4 18,65177 37,30354 23,84188 47,68376
0,5 23,31471 46,62942 29,80235 59,60471
0,63 29,37654 58,75308 37,55096 75,10193

OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D Page 51 of 61

 ENGLISH

0,8 37,30354 74,60708 47,68376 95,36753

1 46,62942 93,25885 59,60471 119,2094
1,25 58,28678 116,5736 74,50588 149,0118
1,6 74,60708 149,2142 95,36753 190,7351
2 93,25885 186,5177 119,2094 238,4188
2,5 116,5736 233,1471 149,0118 298,0235
3,2 149,2142 298,4283 190,7351 381,4701

BLD Shape Circular

SSD (mm) 200
kV 60 70
mA 4 8 4 8
Time (s) DAP (mGy*cm2)
0,02 2,281096 4,562192 2,915842 5,831685
0,025 2,85137 5,70274 3,644803 7,289606
0,032 3,649753 7,299507 4,665348 9,330695
0,04 4,562192 9,124383 5,831685 11,66337
0,05 5,70274 11,40548 7,289606 14,57921
0,063 7,185452 14,3709 9,184903 18,36981
0,08 9,124383 18,24877 11,66337 23,32674
0,1 11,40548 22,81096 14,57921 29,15842
0,125 14,25685 28,5137 18,22401 36,44803
0,16 18,24877 36,49753 23,32674 46,65348
0,2 22,81096 45,62192 29,15842 58,31685
0,25 28,5137 57,0274 36,44803 72,89606
0,32 36,49753 72,99507 46,65348 93,30695
0,4 45,62192 91,24383 58,31685 116,6337
0,5 57,0274 114,0548 72,89606 145,7921
0,63 71,85452 143,709 91,84903 183,6981
0,8 91,24383 182,4877 116,6337 233,2674
1 114,0548 228,1096 145,7921 291,5842
1,25 142,5685 285,137 182,2401 364,4803
1,6 182,4877 364,9753 233,2674 466,5348
2 228,1096 456,2192 291,5842 583,1685
2,5 285,137 570,274 364,4803 728,9606
3,2 364,9753 729,9507 466,5348 933,0695

Page 52 of 61 OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D

 ENGLISH

BLD Shape Rectangular

SSD (mm) 310
kV 60 70
mA 4 8 4 8
Time (s) DAP (mGy*cm2)
0,02 0,580458 1,160916 0,741979 1,483957
0,025 0,725573 1,451145 0,927473 1,854947
0,032 0,928733 1,857466 1,187166 2,374332
0,04 1,160916 2,321833 1,483957 2,967915
0,05 1,451145 2,902291 1,854947 3,709893
0,063 1,828443 3,656886 2,337233 4,674466
0,08 2,321833 4,643665 2,967915 5,935829
0,1 2,902291 5,804582 3,709893 7,419787
0,125 3,627864 7,255727 4,637367 9,274733
0,16 4,643665 9,287331 5,935829 11,87166
0,2 5,804582 11,60916 7,419787 14,83957
0,25 7,255727 14,51145 9,274733 18,54947
0,32 9,287331 18,57466 11,87166 23,74332
0,4 11,60916 23,21833 14,83957 29,67915
0,5 14,51145 29,02291 18,54947 37,09893
0,63 18,28443 36,56886 23,37233 46,74466
0,8 23,21833 46,43665 29,67915 59,35829
1 29,02291 58,04582 37,09893 74,19787
1,25 36,27864 72,55727 46,37367 92,74733
1,6 46,43665 92,87331 59,35829 118,7166
2 58,04582 116,0916 74,19787 148,3957
2,5 72,55727 145,1145 92,74733 185,4947
3,2 92,87331 185,7466 118,7166 237,4332

OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D Page 53 of 61

 ENGLISH

ANNEX 5
A5. ELECTROMAGNETIC COMPATIBILITY

Electromagnetic compatibility (EMC) is assessed with reference to the following standards:

CEI EN 60601-1-2: 2007, 3rd edition

EMISSION

• CEI EN 55011: 2013

• CEI EN 61000-3-2: 2015
• CEI EN 61000-3-3: 2014

IMMUNITY

• CEI EN 61000-4-2: 2011

• CEI EN 61000-4-3: 2007 + A1: 2008
• CEI EN 61000-4-4: 2013
• CEI EN 61000-4-5: 2007
• CEI EN 61000-4-6: 2011
• CEI EN 61000-4-8: 2013
• CEI EN 61000-4-11:2006

Guidance and manufacturer’s declaration – electromagnetic emissions

“x-mind dc” is intended to be used in the electromagnetic environment specified below. The customer or the
operator of “x-mind dc” must ensure that the device is used in this type of environment.
Electromagnetic
Emission test Conformity
environment guidance
“x-mind dc” uses RF energy only for internal
RF emissions operation. RF emissions are extremely and
Group 1
CISPR 11 attenuated are not likely to generate interference
with electronic equipment in the vicinity.
RF emissions
Class B
CISPR 11
“x-mind dc” is suitable for use in all establishments,
Harmonic emissions including domestic establishments and those
Class A
CEI EN 61000-3-2 directly connected to the public low-voltage power
supply network that supplies buildings used for
Voltage fluctuations/flicker
domestic purposes.
emissions Complies
CEI EN 61000-3-3

Page 54 of 61 OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D

 ENGLISH

Guidance and manufacturer’s declaration – electromagnetic immunity

“x-mind dc” is intended to be used in the electromagnetic environment specified below. The customer or
“x-mind dc” operator must ensure that the device is used in this type of environment.
Electromagnetic
Immunity test CEI EN 60601 test level Compliance level environment
guidance
Floors should be wood, concrete or
Electrostatic
+/- 6 kV contact CEI EN 60601-1-2 ceramic tile. If floors are covered
discharge (ESD)
+/- 8 kV air Test level with synthetic material, the relative
CEI EN 61000-4-2
humidity must be at least 30%
Electrical fast Mains power quality should conform
+/- 2 kV for power supply lines CEI EN 60601-1-2
transient/burst to that of typical commercial or
+/- 1 kV for input/output lines Test level
CEI EN 61000-4-4 hospital applications.
Mains power quality should conform
Surge +/- 1 kV differential mode CEI EN 60601-1-2
to that of typical commercial or
CEI EN 61000-4-5 +/- 2 kV common mode Test level
hospital applications.
<5 % UT for 0.5 cycles
(>95 % dip in UT)
Mains power quality should conform
Voltage dips, short
40 % UT for 5 cycles to that of typical commercial or
interruptions and
(60 % dip in UT) hospital applications. If the “x-mind
voltage variations CEI EN 60601-1-2
dc” operator requires continued
on power supply Test level
70 % UT for 25 cycles operation even during mains
input lines
(30 % dip in UT) power outage, we recommend
CEI EN 61000-4-11
powering the system using a UPS.
<5 % UT for 5 onds
(>95 % dip in UT)
Mains frequency Power frequency magnetic fields
(50/60 Hz) CEI EN 60601-1-2 must be at the typical level of
3 A/m
magnetic field Test level standard mains for commercial or
CEI EN 61000-4-8 hospital use.
Note: Ut is the AC mains voltage prior to the application of the test level.

OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D Page 55 of 61

 ENGLISH

Guidance and manufacturer’s declaration – electromagnetic immunity

“x-mind dc” is intended to be used in the electromagnetic environment specified below. The customer or
“x-mind dc” operator must ensure that the device is used in this type of environment.
CEI EN 60601 Compliance Electromagnetic
Immunity test
test level level environment guidance
Portable and mobile RF communication
equipment must be used no any closer to any
part of the “x-mind dc”, including cables than the
recommended separation distance, calculated
according to the equation corresponding to the
frequency of the transmitter.
Conducted RF 3 Vrms Recommended separation distance
3 Vrms
CEI EN 61000-4-6 150 kHz to 80 MHz d = 1,2 √P
d = 1,2 √P 80 MHz - 800 MHz
d = 2,3 √P 800 MHz - 2.5 GHz

where P is the maximum output power rating

of the transmitter in watts (W) according to
the transmitter manufacturer and “d” is the
recommended separation distance in metres
(m).
Field strength from fixed RF transmitters
Radiated RF 10 V/m
3 V/m as determined by an electromagnetic site
CEI EN 61000-4-3 80MHz to 2.5GHz
surveya must be below the compliance level
corresponding to each frequency range.b
Interference can occur in the proximity of
equipment marked with the following symbol :

Notes:
• At 80 MHz and 800 MHz the higher frequency range applies.
• These guidelines may not apply in every situation. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a - Field strength from fixed RF transmitters, such as base stations for radio (cellular/wireless) telephones and
land mobile radios, amateur radio, AM and FM radio and TV broadcast cannot be predicted with accuracy
on a theoretical basis. To assess the electromagnetic environment created by fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the place where the
equipment is used exceeds the corresponding RF compliance level (see above), it is important to ensure regular
equipment operation. In the event of abnormal operation, additional measures may be required, such as
redirecting or relocating “x-mind dc”.
b - Over the frequency range between 150 kHz and 80 MHz, the field strength must be below 10 V/m.

Page 56 of 61 OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D

 ENGLISH

Recommended separation distances between portable and mobile RF communication equipment

and “x-mind dc” medical device
These devices are intended to be used in environments where radiated RF interference is controlled. The
customer or “x-mind dc” operator can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communication equipment (transmitters) and “x-mind dc”, as indicated
below, according to the maximum output power of the communication equipment.
Separation distance according to transmitter frequency
Rated maximum output [m]
power of the transmitter
[W] 150 kHz - 80 MHz 80 MHz - 800 MHz 800 MHz - 2.5 GHz
d = 1,2 √P d = 1,2 √P d = 2,3 √P
0.01 0.12 0.12 0.24
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
In the event of transmitters whose maximum nominal output power coefficient does not fall within the indicated
parameters, the recommended separation distance in metres (m) can be determined by means of the equation
corresponding to the frequency of the transmitter, where P is the maximum output power coefficient of the
transmitter in watts (W) according to the information provided by the manufacturer.
Note 1: At 80 MHz and 800 MHz apply the separation distance corresponding to the highest frequency range.
Note 2: These guidelines may not apply in every situation. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.

OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D Page 57 of 61

 ENGLISH

ANNEX 6
A6. DRAWINGS AND DIMENSIONS

WALL INSTALLATION

Lateral view (rest position)

Bottom mount

A
40 cm (16’’) bracket 63 cm
80 cm (31’’) bracket 104 cm
110 cm (43’’) bracket 132 cm

Page 58 of 61 OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D

 ENGLISH

Lateral view (open)

Bottom mount

B
40 cm (16’’) bracket 178 cm
80 cm (31’’) bracket 220 cm
110 cm (43’’) bracket 247 cm

The system can also be mounted with the timer on the top. For details, refer to the Installation and Maintenance
Manual.

MOBILE INSTALLATION

“x-mind dc” exists also in the mobile version and it is sustained by the stand shown in the following figure:

For details, refer to the Mobile Unit Technical Note, supplied with this structure.

OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D Page 59 of 61

 ENGLISH

ANNEX 7
A7. INSTALLATION ELECTRICAL SCHEME

Page 60 of 61 OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D

 de Götzen S.r.l • A company of ACTEON Group
Via Roma 45 • 21057 OLIGATE OLONA (VARESE) • ITALY
Tel +39 0331 376 760 • Fax +39 0331 376 763
E-Mail: [email protected] •www.acteongroup.com