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INSTALLATION &

MAINTENANCE MANUAL

INSTALLATION & MAINTENANCE MANUAL • X-MIND AC • V2 • (06) • 08/2016 • NXACEN020B


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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.degotzen.com - www.acteongroup.com
E-mail: degotzen@degotzen.com

For technical support:

degotzen@acteongroup.com
www.acteongroup.com

ITALY

For information and technical assistance, contact the manufacturer


Direct Tel.: +39 0331 376762
service@degotzen.com

WORLDWIDE

Contact your authorised local dealer.


Refer to the list in the following page to find the authorised dealer near you.

THE RADIOGRAPHIC SYSTEM DESCRIBED IN THIS MANUAL REFERS TO A WALL INSTALLATION.

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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 ac®” 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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4 INSTALLATION & MAINTENANCE MANUAL • X-MIND AC • V2 • (06) • 08/2016 • NXACEN020B


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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...............................................................................................................................27
5.1. CHART OF DEFAULT EXPOSURE VALUES...............................................................................27
CHAPTER 6...............................................................................................................................32
6.1. PROGRAMMING DEFAULT EXPOSURE VALUES....................................................................32
6.2. RESTORING ORIGINAL VALUES..............................................................................................34
CHAPTER 7...............................................................................................................................35
7.1. DIAGNOSTIC.............................................................................................................................35
CHAPTER 8...............................................................................................................................36
8.1. ERROR MESSAGES....................................................................................................................36
CHAPTER 9...............................................................................................................................37
9.1. VERIFICATION OF THE EXPOSURE FACTORS........................................................................37
CHAPTER 10.............................................................................................................................39
10.1. SUGGESTED MAINTENANCE................................................................................................39
10.2. CLEANING THE OUTER SURFACES.......................................................................................39
CHAPTER 11.............................................................................................................................41
11.1. REPAIR.....................................................................................................................................41
11.2. DISPOSAL................................................................................................................................41
ANNEX 1..................................................................................................................................42
A1. TECHNICAL SPECIFICATIONS..................................................................................................42
ANNEX 2..................................................................................................................................46
A2. INTENDED ENVIRONMENT......................................................................................................46
ANNEX 3..................................................................................................................................47
A3. LIST OF INTERNATIONAL STANDARDS AND DIRECTIVES....................................................47
ANNEX 4..................................................................................................................................48
A4. DOSIMETRIC INDICATIONS.....................................................................................................48
ANNEX 5..................................................................................................................................49
A5. ELECTROMAGNETIC COMPATIBILITY.....................................................................................49
ANNEX 6..................................................................................................................................53
A6. DRAWINGS AND DIMENSIONS...............................................................................................53
ANNEX 7..................................................................................................................................55
A7. INSTALLATION ELECTRICAL SCHEME.....................................................................................55

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CONTROL PANEL

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1
CHAPTER 1
1.1. PRELIMINARY INFORMATION

Before beginning to use the “x-mind ac®” 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 INSTALLER

CAUTION

The installer is responsible for the installation, with regards to the system safety and operation.

For safe and reliable installation of the “x-mind ac®” 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. – ACTEON Group the warranty certificate duly filled in: if this is not done, the warranty
is not valid.

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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 “x-mind ac®” 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 ac®” for reference;

- in case of repair, please use only spare parts from the manufacturer of the “x-mind ac®”; 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
“x-mind ac®” 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 “x-mind ac®” 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
transport documentation or on the consignment note.

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1.5. SAFETY WARNINGS

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

CAUTION

GENERAL REQUIREMENTS

RESPONSIBLE ORGANIZATION is the authority that has the responsibility for the USE and MAINTENANCE of the “x-mind ac®” radiographic sys-
tem. The training and preparation of personnel is the responsibility of THE RESPONSIBLE ORGANIZATION.

“x-mind ac®” radiographic system is an Xray 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 qualified, authorized
professional technicians. It is mandatory to ensure patients’ health and safety and proper “x-mind ac®” 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 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 ac®” radiographic system has been designed to acquire radiographic images for dental intraoral X-ray imaging. The “x-mind ac®”
medical device must not be used for X-ray imaging of other body parts.

Carefully follow the instructions in this manual to install, operate and maintain the “x-mind ac®” 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 responsible to monitor the patient and the parameters of the “x-mind ac®” radiographic system throughout the entire duration
of the X-ray examination.

It is prohibited to modify any part of the “x-mind ac®” 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 in 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 “x-mind ac®” radiographic system you must assure that the device has no visible signs of damage.

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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 ac®” is a medical device that generates X-rays; therefore, both the patients and the operator are exposed to risks due to ionizing
radiation. The physician must assess the actual need for X-ray exposure.

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 “x-mind ac®” 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 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 ac®” 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 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 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 ac®” do not
interfere with its functionality.

“x-mind ac®” 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 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 ac®” 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’s prohibited to inspect internal parts of the system.

Never attempt to open the X-ray tubehead.

The covers on the “x-mind ac®” 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 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 defined in CEI EN 60601-1, edition 3, clause 16.

For the wall version of “x-mind ac®”:


based on the CEI EN 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.

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CAUTION

EMC COMPATIBILITY

EMC requirements must be considered and the “x-mind ac®” 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 CEI EN 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.

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2
CHAPTER 2
2.1. RADIOGRAPHIC SYSTEM

The “x-mind ac®” radiographic system guarantees the maximum safety both for the operator and the patient.

It is built in compliance with the following European Directives:


} 93/42/EEC and subsequent amendments MEDICAL DEVICES
} EURATOM 96/29 IONISING RADIATIONS

and in compliance with the following American Standard:


} American Radiation Performance Standard 21CFR, 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 the
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 self-compensating technology which, by revealing
voltage fluctuation, is able to modulate the irradiation time ensuring the proper level of dose;
- 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 confirming 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

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2.2. SYSTEM COMPONENTS

x-mind ac®” radiographic system (Fig. 1) consists of:

1. x-mind ac® 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 ac tubeheads.
In case of alternate current tubeheads the technology of the timer is “self - compensating”:
depending on the line voltage fluctuation, the microprocessor automatically modifies the predetermined expo-
sure time ensuring a constant dose to the patient.
This technological expedient avoids the repetition of the exposure because of over/under exposure errors.

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 fixed 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 x-mind ac®


The intra-oral tubehead “x-mind ac®” is a monoblock type and its light alloy housing contains an airtight com-
partment.
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.

6. CONE
The collimator cone or Beam Limiting Device represents the applied part of the device. Made of the transparent
polycarbonate, it allows:

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- 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 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 possibi-
lity of inflammations or other types of reactions of the skin caused by contact with the material that constitutes
the cone.

OPTIONAL ACCESSORIES

}SECOND CONTROL BUTTON


}x-mind ac® LIGHT (X-ray signalling lamp for external use)
}x-mind ac® ECB (remote control button)

PLEASE NOTE

For the installation of the optional accessories, refer to the specific installation manuals supplied.

2.3. OVERALL DIMENSIONS

Fig. 2A, 2B, 2C give the overall dimensions of the possible supply conditions:
BRACKET 400: L = 41 cm – 16” 9/64
BRACKET 800: L = 82,5 cm – 32” 31/64
BRACKET 1100: L = 110 cm – 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 identification 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: x-mind ® ac
de Götzen® S.r.l.
Via Roma 45 - 21057 Olgiate Olona (VA) - ITALY

70kVp 8mA Total filtration: 2,3mm Al / 70kV 0.7mm


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

Model 220 V

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

70kVp 8mA Total filtration: 2,3mm Al / 70kV 0.7mm


Rated line voltage: 220V ~ 50/60Hz Class I
X-ray tube: TOSHIBA DG-073B-AC
SN SN tube:

Model 115 V
Model: x-mind ® ac
de Götzen® S.r.l.
Via Roma 45 - 21057 Olgiate Olona (VA) - ITALY

70kVp 8mA Total filtration: 2,3mm Al / 70kV 0.7mm


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

2.3.2. TIMER

Model 230 V
Model: x-mind ® ac
®
de Götzen S.r.l.
Via Roma 45 - 21057 Olgiate Olona (VA) – ITALY

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


Absorbed power:0,8kVA IP20
SN

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Model 220 V

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

Rated line voltage: 220V ~ 50/60Hz Class I


Absorbed power: 0,79kVA IP20
SN

Model 115 V

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

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


Absorbed power: 0,66kVA IP20
SN

CONE

GRADUATED SCALE

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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

REFER TO MANUAL’S INSTRUCTIONS

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

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3
CHAPTER 3
3.1. INSTALLATION SPECIFICATIONS

! WARNING

Prior to installing the radiographic system the Responsible Organisation must as certain that:
the environment, the electric system and the power supply comply with the requirements needed, otherwise he must provide the required
adjustment.

ENVIRONMENT REQUIREMENTS
- The installation environment must be wide enough: check that the size and overall dimension of the environment
don’t present any obstacle while positioning the radiographic system.
- The environment must not be exposed to explosion hazards and must not be pressurized.
- While operating, the ambient temperature must range within +5°C and +40°C.
- The storage temperature must range within -15°C and +50°C.
- The relative humidity must range within 25% and 75%.

REQUIREMENTS OF THE SUPPORTING WALL


- The radiographic system supporting wall must be able to stand a 200 Kg tear at every fixing point.

PLEASE NOTE

It is mandatory to check the nature and consistency of the wall and, if required, ask the support of a brickwork expert.
The walls of uncertain consistency must be provided with a buried counter plate or with a sandwich type system.

REQUIREMENTS OF THE ELECTRIC SYSTEM

- The electric system must comply with the regulations in force.


- The electric system must be able to supply the power and voltage required in the manufacturer’s rating plate of
the radiographic system (Chart A).

Chart A
MANUFACTURER’S RATING PLATE
220 V ± 10% 230 V ± 10% 115 V ± 10%
ELECTRIC SYSTEM
NOMINAL VOLTAGE 220 V 230 V 115 V
MINIMUM LINE VOLTAGE 198 V 207 V 103,5 V
MAXIMUM LINE VOLTAGE 242 V 253 V 126,5 V
FREQUENCY 50 / 60 Hz 50 / 60 Hz 50 / 60 Hz
ABSORBED POWER 0,79 kVA 0,8 kVA 0,66 kVA

REQUIREMENTS OF THE ELECTRIC LINE

- The electric line must be “single phase alternate” type.


- It is essential a 10A – 250V, magnetothermic differential switch be fit upstream the radiographic system, with
differential protection In£30mA (refer to Chapter 15).
- The power conductors of the timer and the connection conductors with the tubehead must be two-pole +
ground with section suitable to the length of the power supply line (Chart B).

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Chart B
220 V ± 10%
MANUFACTURER’S RATING PLATE 115 V ± 10%
230 V ± 10%
POWER SUPPLY VOLTAGE 198 ≤ V ≤ 253 103,5 ≤ V ≤ 126,5
MINIMUM CONDUCTOR SECTION 1,5 mm2
MAXIMUM LINE LENGHT 10 m
MAXIMUM CONDUCTOR SECTION 2,5 mm2
MAXIMUM LINE LEGHT 20 m

PLEASE NOTE

For longer lines, the conductor section must be increased in proportion.

- The cables (S11, S12 – S21, S22) connecting the timer and the X-ray signalling lamp for external use must be
two-pole type, of section 0,5mm2.
- The electric line characteristics must have the following characteristics (Chart C):

Chart C
MANUFACTURER’S RATING PLATE 220 V ± 10%
115 V ± 10%
ELECTRICAL LINE 230 V ± 10%
MAXIMUM VOLTAGE DROP 3%
APPARENT LINE RESISTANCE 0,5 Ω 0,2 Ω

ELECTRIC CONNECTIONS

! WARNING

Prior to installing the radiographic system, it is advisable that all the electric connections are arranged.

TIMER
On the timer installation wall, according to the installation electric diagram (refer to Chapter 15), suitable runs for
the following electric cables must be provided:
} timer electric cables;
} cables for the connection between timer and tubehead;
} cables for the connection between the timer and the X-ray signalling lamp for external use x-mind ac® LIGHT
(OPTIONAL);
} cables for the connection between the timer and the remote control button x-mind ac® ECB (OPTIONAL).

CAUTION

According to the relevant standard, the timer must be installed in a position that allows the operator to constantly control the radiographic
exposure.

TUBEHEAD
On the wall plate installation wall, a suitable run for the cable connecting timer and tubehead must be provided.

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4
CHAPTER 4
4.1. INSTALLATION

CAUTION

The “x-mind ac®” radiographic system must be installed by professionally trained technicians, who must be able to certify their work by “Decla-
ration of Conformity”.

! WARNING

Prior to installing the radiographic system, it is advisable to verify that all needed requirements have been satisfied (refer to Chapter 3).

4.2. UNPACKING

The components of the “x-mind ac®” radiographic system are duly packed within a carton box, as shown in the
Fig. 5:

1. TUBEHEAD PACKAGING
2. TIMER + OPTIONAL PACKAGING
3. PANTOGRAPH TYPE ARM PACKAGING
4. WALL PLATE and BRACKET PACKAGING
D MANUALS and WARRANTY CARD

PLEASE NOTE

Prior to installation, duly check all components.

PLEASE NOTE

The carton board and the polystyrene foam can be completely recycled and can be disposed by authorized recycling companies.

PLEASE NOTE

It is advisable to store the original packaging to return the goods for repairs.

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4.3. ASSEMBLING THE WALL PLATE

! WARNING

When the timer is installed aside the wall plate, please consider what follows:
} the timer must be mounted on the left side of the wall plate;
} the distance between timer and wall plate must be 2,5mm.

! WARNING

To fix the wall plate DO NOT use plastic or rubber anchor screws.
For cement walls, or built with solid or hollow bricks, use metal anchor screws Ø12 (NOT included in the supply).

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ASSEMBLY INSTRUCTION (refer to Fig. 6)

1. Take out from the packaging the wall plate and the drilling template 1.
2. Position the drilling template 1 on the radiographic system installation wall, at the required height (130cm
from the base in the suggested height).
3. Fix the template 1 with adhesive tape.
4. Check the holes for verticality and alignment with the floor, using a plumb line.
5. Mark the wall plate 8 fixing holes.
6. If required, mark the holes for the electric cables connecting the timer to the tubehead.

PLEASE NOTE

To prevent any flaking in the white coat and to control the centre distances between the holes, it is advisable to start drilling with a tip Ø7,
increasing this measure gradually.

7. Drill the fixing holes.


8. Remove the template 1 and insert the suitable anchor screws 2, according to the wall characteristics.
9. Unscrew the screw 3 and remove the plug 4 from the wall plate 8.
10. Withdraw the sliding cover 5.
11. Approach the wall plate 8 to the wall and insert the screws 7 with the relevant washers 6, then tighten
alternately.
12. Check that the wall plate 8 is steadily fixed to the wall.

PLEASE NOTE

If the wall is not perfectly levelled, put a suitable shim between the wall and the wall plate, so as to prevent any possible deformations.

4.4. ASSEMBLING THE BRACKET

PLEASE NOTE

The 82,5cm and 110cm brackets are provided with a stop key 1 (Fig. 7A and 7B) to prevent the electric cable from twisting.

PLEASE NOTE

Generally, the stop key is installed so that the equipment position at rest is on the right side of a possible watcher standing in front of the
wall plate (Fig. 7A). Should the position at rest be on the left side, the stop key must be rotated by 180° (Fig. 7B).

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ASSEMBLY INSTRUCTION (refer to Fig. 8)

1. Take out the bracket from the packaging.


2. Insert the bracket pin 3 into the wall plate 1 (upwards).
3. Insert the supporting rest 2.

PLEASE NOTE

Prevent all foreign matters (ground, dust, cement, etc.) from settling on the pin seat.
The pin must slide freely in its seat.
If required, thoroughly clean and lubricate with grease Molikote D.

PLEASE NOTE

Check accurately with a line level instrument, the exact concurrency between the bracket and the ground floor.

4.5. ASSEMBLING THE PANTOGRAPH ARM

ASSEMBLY INSTRUCTION (refer to Fig. 9)

1. Take out the pantograph arm from the packaging.


2. Remove the bracket plug 1 by unscrewing the fixing screw 2.
3. Slide the bracket guard slat 3.
4. Insert the pantograph group cable 5 into the bushing 4 and then the pantograph pin 6.
5. If required, clean the pin and the bushing and lubricate with grease Molikote D.
6. Insert the electric cable into the bracket housing 7.
7. Assemble the guard slat.
8. Insert the cable into the bracket and push it until reaches the pin outlet near the supply terminal board.

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4.6. ASSEMBLING THE TIMER

CAUTION

Check that the cable runs are arranged in the timer installation wall; check the compliance of the power supply with the installation specifica-
tions (refer to Chapter 3).

! WARNING

Check that the rating data match the power supply voltage.

! WARNING

When the timer is installed aside the wall plate, please consider what follows:
} the timer must be mounted on the left side of the wall plate;
} the distance between timer and wall plate must be 2,5mm;

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ASSEMBLY INSTRUCTION (refer to Fig. 10 - 11)

1. Take out of the packaging the timer and the drilling template 1.
2. Position the drilling template 1 on the radiographic system installation wall, at the required height.
3. Fix the template 1 with adhesive tape.
4. Check the holes for uprightness and alignment with the floor, using a plumb line.
5. Mark the timer fixing holes on the wall using the drilling template.
6. If required, mark the holes for the electric cables connecting the timer to tubehead.
7. Drill using a Ø3 tip, then drill again with a Ø6 tip to prevent any flaking of the white coat.
8. Remove the template 1 and insert the suitable anchor screws provided 2.
9. Open the timer by unscrewing the three screws 8.
10. Withdraw the 26-pole connector from its seat to release both timer guards.
11. Approach the timer 8 to the wall and insert the electric feeding cables into the slot A or the slot B.
12. Insert the connection cables coming from the tubeheads into the slot A or the slot B:
when the timer is installed aside the wall plate insert in between the rubber cover for the electrical cable.
13. Insert the cables of the X-ray signaling lamp for external use (OPTIONAL) and the cables of the remote
control button (OPTIONAL) into the slot A or the slot B.
14. Approach the timer base 8 to the wall, matching the three anchor screws with the holes screw the screws
with the relevant washers.

PLEASE NOTE

The use of the slots A or B for the cables is arbitrary; use the slots which adapt better to the specific configuration of installation.

4.7. ASSEMBLING THE TUBEHEAD

ASSEMBLY INSTRUCTION

1. Take from the packaging the tubehead.


2. Check that all the rating data match the power supply voltage.

3. Remove both guards from the pantograph type arm by loosening the relevant
screws.

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4. Using a tip, act on the front coupling device.

5. Remove both guards.

6. Insert the tubehead pin into the pantograph head.

7. Insert the supporting rest.

8. Check that during insertion, the pin of the turning preventing device correctly
fits the seat located on the pantograph head.

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9. Couple the pantograph and tubehead connections and fit the into their seats.

4.8. BALANCING THE PANTOGRAPH ARM

CAUTION

The pantograph arm must be adjusted only when the tubehead is assembled (fig. 12).

! WARNING

To prevent damages to the internal mechanism while performing adjustment and balancing tests, the adjustment key must not be left in
place.

! WARNING

The adjustment key provided must be carefully kept.

PLEASE NOTE
To reach the adjustment screw X, the arm A must be put in vertical position.
To reach the adjustment screw Y, the arm B must be put in horizontal position.
The adjustment key provided can be inserted only under the above conditions.

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INSTRUCTION (refer to Fig. 12)

1. BALANCING THE ARM A

PLEASE NOTE
The pantograph arm is supplied with arm A already preloaded.
The arm B is supplied unloaded for safety reasons.

2. BALANCING THE ARM B

} arm A vertical
} arm B horizontal
} insert the adjustment key in Y
} load the spring by n° 22 turns
} withdraw the key

3. CHECKING THE BALANCING

bring the arm B in the different positions


IF IT DOES NOT KEEP THE POSITION

} bring the arm B to the horizontal position


} insert the adjustment key in Y
} rotate the adjustment key by half turn:
} clockwise if it tends to come down;
} counter clockwise if it tends to go up
} withdraw the key

PLEASE NOTE
Repeat the test and adjustment until the arm B is steady and stable in all positions, even when the arm A is completely extended.

4. READJUSTMENT OF ARM A

} bring the arm A to the vertical position


} insert the adjustment key in X
} rotate the adjustment key by half turn: clockwise if it tends to come down; counter clockwise if it tends to go
up
} withdraw the key

PLEASE NOTE
Repeat the test and adjustment until the arm A is steady and stable in all positions, even when the arm B is completely extended.

5. Insert the movable finish F between the pantograph type arm guard and metal
frame.

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6. Insert the pins of the guards into the relevant seats; then position them and
check that the movable finish is coupled to the guards.

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5
CHAPTER 5
5.1. ELECTRIC CONNECTION

CAUTION

Before proceeding to connections, the power supply must be cut off.

CAUTION

For electric safety, it is essential that the ground conductors are correctly connected.

! WARNING

While performing the connection, always respect the polarity PHASE/ NEUTRAL.

! WARNING

While stripping the cables, pay attention to the small copper wires that may fall on the printed circuit and cause short circuits or malfunc-
tions.

CONNECTION TO THE SUPPLY TERMINAL BOARD INSTRUCTION

1. Remove the terminal board cover 1 by unscrewing the fixing screw 2.

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2. Proceed with the electric connection as shown below:

TERMINAL BOARD CONNECTION DIAGRAM

1 BROWN L = PHASE
2 YELLOW GREEN T = GROUND
3 BLUE N - NEUTRAL
4 Not connected
5 Not connected
6 YELLOW GREEN T = GROUND
7 YELLOW GREEN T = GROUND

3. Connect the pantograph cable shield to the grounding potential 6.

4. Connect the wall plate to the grounding potential 7.

5. Clamp the cables with the cable clamps provided.

6. Reassemble the terminal board cover.

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CONNECTION TO THE TIMER INSTRUCTION

1. Connect the power supply cable to the terminal board α.


2. Insert the three mains cables into the rack.
3. Fix them with the cable clamp β.
4. Connect the cables coming from the tubehead 1 to the terminals XRAY1.
5. Connect the yellow-green grounding cable to the equipotential metal plate δ.
6. Connect the cables coming from the tubehead 2 to the terminals XRAY2.
7. Connect the yellow-green grounding cable to the equipotential metal plate δ.
8. Clamp the cables in the cable clamp γ.
9. Connect the X-ray signalling lamps for external use (OPTIONAL).
10. Connect the remote control buttons (OPTIONAL).
11. Check the configuration on the dipswitches.
12. Reconnect the 26-pole connector.
13. Close the timer with the three screws.
14. Mount the sliding cover and the plug of the wall plate.
15. Reconnect the power supply.

1 TUBEHEAD 1 CONTROL BUTTON


2 TUBEHEAD 2 CONTROL BUTTON - OPTIONAL
3A TUBEHEAD 1 X-ray SIGNALLING LAMP - OPTIONAL
3B TUBEHEAD 2 X-ray SIGNALLING LAMP - OPTIONAL
4A NOT AVAILABLE
4B NOT AVAILABLE
5 TUBEHEAD 1 POWER SUPPLY
6 TUBEHEAD 2 POWER SUPPLY
7 TIMER POWER SUPPLY

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6
CHAPTER 6
6.1. CONFIGURATION

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

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

No. of the selected tubehead


LED 1

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

Type of tubehead
LED AC = ALTERNATE CURRENT

radiographic voltage
LED 70kV

radiographic current
LED 8mA

type of patient
LED ADULT

radiographic technique
CONVENTIONAL LED D

The above configuration depends on the position of dip-switch on the timer electronic card:

LEGEND
ON = INSTALLED
OFF = NOT INSTALLED

IF THE LONG CONE IS USED 31cm = 12” (SSD)

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ON OFF
1 ■ TUBEHEAD 1
2 ■ TUBEHEAD AC
3 ■ TUBEHEAD 2
4 ■ TUBEHEAD AC
5 ■ II° CONTROL BUTTON
6 ■ LONG CONE 12’’ (31cm)
7 ■ NOT AVAILABLE
8 ■ NOT AVAILABLE

IF THE SHORT CONE IS USED 20cm = 8” (SSD)

ON OFF
1 ■ TUBEHEAD 1
2 ■ TUBEHEAD AC
3 ■ TUBEHEAD 2
4 ■ TUBEHEAD AC
5 ■ II° CONTROL BUTTON
6 ■ SHORT CONE 8’’ (20cm)
7 ■ NOT AVAILABLE
8 ■ NOT AVAILABLE

6.2. CHANGING THE CONFIGURATION

Possible modifications of the exposure values

►Type of patient (ADULT/CHILD)


►Radiographic technique
(refer to “User’s Manual” Chapter 4)

Possible modifications of the exposure values

►N° of tubehead (1/2)


►N° control button
►Type of cone (8” /12”)
inside the timer, by changing the dip-switch position
THIS OPERATION MUST BE CARRIED OUT BY THE INSTALLER ONLY

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DIP SWITCH ON OFF PARAMETER


1 INSTALLED NOT INSTALLED TUBEHEAD 1
2 dc ac TUBEHEAD TYPE 1
3 INSTALLED NOT INSTALLED TUBEHEAD 2
4 dc ac TUBEHEAD TYPE 2
5 INSTALLED NOT INSTALLED II° CONTROL BUTTON
6 LONG 12’’ = 30cm SHORT 8’’ = 20cm CONE
7 NOT AVAILABLE
8 NOT AVAILABLE

INSTRUCTION

To change the number of the tubehead installed, move the dip-switch n° 1 or the dip-switch n° 3:

DIP SWITCH 1 3
ON ON
OFF OFF

►if the tubehead is connected to the XRAY1 terminal board, put the dip-switch n° 1 in the ON position; otherwise
in OFF position;

►if the tubehead is connected to the XRAY2 terminal board, put the dip-switch n° 3 in the ON position; otherwise
in OFF position.

To change the type of tubehead installed, move the dip-switch n° 2 or the dip-switch n° 4:

DIP SWITCH 2 4
ON ON
OFF OFF

►if the tubehead connected to the XRAY1 is ac, put the dip-switch n° 2 in the OFF position; otherwise put it in
the ON position;

►if the tubehead connected to the XRAY2 is ac, put the dip-switch n° 4 in the OFF position; otherwise put it in
the ON position.

PLEASE NOTE

It is possibile to connect to the timer of type AC: n° 2 x-mind ac® tubeheads

To change the amount of control buttons installed, move the dip-switch n° 5:

DIP SWITCH 5
ON
OFF

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►with second control button move the dip-switch n° 5 to the ON position.

PLEASE NOTE

After modification, each tubehead is controlled by the corresponding button.

To change the cone installed, move the dipswitch n° 6:

DIP SWITCH 6
ON
OFF

►with short cone (8”=20cm (SSD)) move the dip-switch 6 to the OFF position;
►with long cone (12”=31cm (SSD)) move the dip-switch 6 to the ON position.

PLEASE NOTE

After modification, the set exposure times are automatically changed.

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7
CHAPTER 7
7.1. START UP

CAUTION

When all connections are completed, the installer must check the electric safety and functions of the system.

INSTRUCTION

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.

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8
CHAPTER 8
8.1. CHECKING THE INSTALLATION

STEP 1 : checking the configuration

Check on the control panel that all LEDs corresponding to the required configuration are lit; otherwise, change
them.

STEP 2 : checking the timer operation

1. Check the correct operation of the control panel by selecting different exposure times.
2. Check the time on the display.
3. Check that, when changing the selected tubehead, the corresponding X-ray signalling lamp for external use
turns on (OPTIONAL).

STEP 3 : checking the exposure

1. Set an exposure time of 1s.


2. On the timer, take the control button corresponding to the selected tubehead and stay at a safety distance (of
at least 2 meters) from the tubehead.

3. On the control button press the X-RAY key and keep it pressed until the acoustic signal (beep) stops and
the yellow LED turns off.

PLEASE NOTE

If the “X-RAY” key is released early, 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.

STEP 4 : checking the operation of the tubehead

Carry out several exposures and check that:


►There are no errors.
►The LED of the selected tubehead is lit.
►The control button LED is lit over the whole duration of the acoustic signal (beep).

STEP 5 : checking the power absorbed by the radiographic system

To check the power absorbed by the radiographic system a tester must be used, in the mode ammeter in AC:

1. Connect the instrument to the power supply line.


2. Set an exposure time of approximately 3s on the timer.
3. Carry out an exposure and read the current value on the instrument.

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PLEASE NOTE

The radiographic system “x-mind ac®” complies with the requirements when:
absorbed current is 3.5A±10% at 220-230V
absorbed current is 5.7A±10% at 115V
Otherwise, check the electrical system or call the “Assistance Service”.

STEP 6 : checking the electric system

To check the electric system, a tester must be used, in the mode voltmeter in AC:

1. Connect the instrument to the terminals L and N on the timer.


2. Measure the line voltage.
3. Connect the instrument to the terminals L and N off the wall plate terminal board.
4. Set an exposure time of approximately 3s on the timer.
5. Proceed to the exposure and measur the line voltage during exposure.

PLEASE NOTE

The electric system complies with the requirements when:


(V0 – V1 ) / V0 < or = 0.03 (3%)
Otherwise, the electric system must be adjusted.

8.2. CHECKING THE EXPOSURE FACTORS

In order to guarantee the 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” instruments.

SET TECHNICAL FACTORS


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

The radiographic voltage is 70kVp ±10%.

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

Dose in air is:


SOURCE-SKIN DISTANCE
31 cm = 12”: 70 kV – 8 mA = 5,5 mGy/s ± 30%
20 cm = 8”: 70 kV – 8 mA = 12 mGy/s ± 30%

STEP 3 : Checking the exposure time (s)

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


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

The exposure time measured is 0,2s ±5% or ±20ms, whichever is larger.

PLEASE NOTE

The “x-mind ac®” timer features the «selfcompensating» technology.


The automatic correction works as follows:
- a voltmeter located inside the timer constantly reads the mains voltage, while the operator selects the required exposure time;
- the last measure collected before the exposure is sent to the internal microprocessor, that corrects the exposure time set by the operator by
applying a special algorithm;
- at the end of the exposure, during the pause time (approx 32 times the set time), the time corrected value is shown on the display of the
timer.
THE CORRECT TIME IS THE ACTUAL DURATION OF THE EXPOSURE
While performing periodic quality checks, some differences between the set exposure time and the measured exposure time may be detec-
ted.
The exposure time is accurate when:
AS REGARDS TO THE SET TIME
►MAXIMUM ERROR IS ±100% WHEN LINE VOLTAGE IS ±10% OF THE NOMINAL VOLTAGE
►MAXIMUM ERROR IS ±10% or ±20ms WHEN LINE VOLTAGE IS EQUAL TO NOMINAL VOLTAGE

AS REGARDS TO THE TIME SHOWN ON DISPLAY


►MAXIMUM ERROR IS ±10% or ±20ms WHEN LINE VOLTAGE IS EQUAL TO NOMINAL VOLTAGE
PERFORM THE CHECK OF ACCURACY OF THE EXPOSURE TIME AS DESCRIBED IN THE FOLLOWING INSTRUCTIONS.

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8.3. ACCURACY OF THE EXPOSURE TIME

1. Put the X-ray detector at the cone outlet centred on the primary beam.
2. Turn on the timer.
3. Set the exposure time to 0.2s on the timer.
4. Carry out the exposure.
5. At the end of the exposure read on the display the actual exposure time.
6. Check the accuracy of the exposure time, use the chart below:

CONFORMITY CHECK CHART

read the time value on the display I°


Actual exposure time

read the measure on the instrument II°


Emission time

subtract I° from II° III°

divide III° by II° IV°


Absolute error

multiply IV° by 100 V°


Percentage error (%)

the accurancy is checked when the % error is ± 5 % or ± 20msec


By adoptiong the most favorable condition

PLEASE NOTE

Otherwise, call the “Assistance Service”.

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9
CHAPTER 9
9.1. DIAGNOSTIC

With “x-mind ac®” radiographic system it is possible to set and visualise certain functional parameters.

To set the parameters, the installer must:

1. turn off the timer;

2. press simultaneously and keep pressed the keys:

(45) MANDIBULARY LOWER MOLAR


(43) MANDIBULARY LOWER CANINE

3. turn on the timer;

4. when the message INST is displayed, the installer can set the minimum exposure time in this way:

►select the tubehead;

►turn off the timer;

►turn on the timer, by keeping pressed the key;

►the message SEC is displayed for approximately 1s;

►the present value of the lower set limit is displayed;

►to change the value, press the keys ;

►to confirm press the key;

5. to exit this mode, turn the timer off and then on again.

! WARNING

Both in digital and in conventional mode, the minimum exposure time must not be less than 0.08s.

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To visualise the parameters proceed as follows:

1. press simultaneously and keep pressed the keys:


(17) MAXILLA MOLAR
(47) MANDIBULARY MOLAR

2. press the key associated to the parameter one wishes to visualise:

KEY DISPLAY PARAMETER

RADIOGRAPHIC SYSTEM
NOMINAL VOLTAGE

LINE VOLTAGE

MAXIMUM LINE VOLTAGE


VALUE DETECTED

MINIMUN LINE VOLTAGE


VALUE DETECTED

SOFTWARE VERSION

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10
CHAPTER 10
10.1. ERROR MESSAGES

The following chart gives a list of error messages that may appear while “x-mind ac®” 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 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”
E22 ANOMALY IN THE CONTROL 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
ALL FUNCTIONS ARE DISABLED
ERR MAJOR ERROR
CALL THE “ASSISTANCE SERVICE”

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11
CHAPTER 11
11.1. SUGGESTED MAINTENANCE

In order to guarantee the 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 ystem 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.

! 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”.

11.2. CLEANING THE OUTER SURFACE

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.

INSTRUCTION

1. Cut off the power supply


2. Release the spring of the arm B of the pantograph type arm using the key provided
3. Remove the tubehead
4. Withdraw the wall plate guard
5. Remove the terminal board cover and disconnect the pantograph type arm cable
6. Remove the bracket plug and withdraw the guard slab
7. Remove the pantograph type arm and the relevant cable from the bracket
8. Remove the bracket from the wall plate
9. Check the vertical alignment of the wall plate: adjust if required
10. Check the six fixing screws of the wall plate: tighten if required
11. Clean the old lubricating grease from the bracket shaft: should the bracket shaft be damaged, install a new
bracket
12. Clean the old lubricating grease of the bracket bush: should the bracket bush be damaged, install a new
bracket
13. Grease the bracket shaft (use grease Molikote D)
14. Lubricate the bracket bush with lubrication grease (use grease Molikote D)
15. Install the bracket in the wall plate
16. Check the pantograph type arm cable: should it be damaged, send the pantograph type arm to the
manufacturer for repairs
17. Check the pantograph type arm guards

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18. Replace the damaged guards


19. Clean the old grease of the shaft: should the shaft be damaged, send the pantograph type arm to the
manufacturer for repairs
20. Lubricate the pantograph type arm shaft with lubricating grease (use grease Molikote D) and reposition it in
the bracket
21. Put again the pantograph type arm cable in the bracket and the wall plate, connect it to the terminal board
and put in place the terminal board cover
22. Position the guard slab in the bracket
23. Position the bracket plug
24. Position the plate guard
25. Check the electric contact of the tubehead: if damaged, send the tubehead to the manufacturer for repairs
26. Clean the old grease from the tubehead assembly shaft
27. Grease the assembly shaft of the tubehead with a thin layer of lubricating grease (use grease Molikote D)
28. Position the tubehead again
29. Load the spring of the pantograph type arm B using the key provided
30. Give power and check the correct operation of the radiographic system

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12
CHAPTER 12
12.1. REPLACEMENT OF FUSES

The timer electronic equipment is protected by n° 4 fuses located on the electronic board.
To replace them proceed as follows:

INSTRUCTION

1. Turn off the power supply.


2. Temporarily remove the guard of the timer 1 by unscrewing the fixing screws 2.

3. Spot the fuse to be replaced.

4. Remove the plastic protection.

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5. Withdraw the fuse.


6. Replace it with one of the same type.

NOMINAL VOLTAGE 115 V ± 10% 220 V ± 10%


230 V ± 10%
PROTECTION FUSES 8 AF – 250 V 6,3 AF – 250 V

7. Put in place the protection.


8. Close the timer guard.
9. Turn on the power supply.

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13
CHAPTER 13
13.1. REPAIR

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

de Götzen® S.r.l. - Acteon Group


Via Roma 45
21057 OLGIATE OLONA VA ITALY

Tel. +39 0331 376760


Fax +39 0331 376763
E-mail: degotzen@degotzen.com

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.

13.2. 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.

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14
CHAPTER 14
14.1. SPARE PARTS

The manufacturer undertakes to supply, upon request, drawings, circuit diagrams, component parts lists,
instructions or other information needed by qualified technical personnel to perform repairs on those parts of
the “x-mind ac®” radiographic system which may be repaired.

REF SPARE PARTS TUBEHEAD x-mind ac® CODE OLD COLOR Q.TY PCS
(RAL 9010 color)
1 AC XG (1) FORK COVER 29700983.C 29700983 7
2 AC/DC XG (2) FORK RING SET 29700980 5
4 AC/DC XG (4) ROTATION STOPPER r.B 29701298 1
5 IX AC/DC XG CONE DISK COIL 21100162 1
A Ø60 DEG ROUND LONG CONE 31cm (12”) 29700397 1
A Ø60 SAT ROUND LONG CONE 31cm (12”) 29701197 1
B Ø60 DEG ROUND SHORT CONE 20cm (8”) 29700396 1
B Ø60 SAT ROUND SHORT CONE 20cm (8”) 29701195 1
C 44x35 DEG SQUARE CONE 31cm (12”) 29700615.C 29700615 1
C 44x35 SAT SQUARE CONE 31cm (12”) 29701199.C 29701199 1

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SPARE PARTS x-mind ac® LIGHT CODE


REF OLD COLOR Q.TY PCS
(OPTIONAL) (RAL 9010 color)
1 XG LIGHT (1) COVER SET INF & SUP 29700977.C 4
2 XG LIGHT (2) LAMP HOLDER 33400372 1
3 XG LIGHT (3) LAMP 230V 15W 33300352 1
3 XG LIGHT (3) LAMPADINA 230V 15W 33300390 1
4 XG LIGHT (4) ELECTRONIC BOARD 230V 39200354 1
4 XG LIGHT (4) ELECTRONIC BOARD 115V 39200353 1
X GENUS EXTERNAL LIGHT 230V KIT
5.15.00032 COMPLETE
COMPLETE KIT
X GENUS EXTERNAL LIGHT 115V KIT
5.15.00034 COMPLETE
COMPLETE KIT

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SPARE PARTS x-mind ac® ECB CODE


REF OLD COLOR Q.TY PCS
(OPTIONAL) (RAL 9010 color)
1 XG ECB (1) COVER SET ING & SUP 29700978.C 4
CONTROL BOARD WITH PUSHBUTTON
2 39700303 1
AND LED
3 XG ECB (3) KEY SWITCH 35100298 1
COMPLETE KIT ECB REMOTE BUTTON 5.15.00033 COMPLETE

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CODE
REF SPARE PARTS TIMER x-mind ac® OLD COLOR Q.TY PCS
(RAL 9010 color)
1 AC/DC TIMER (1) DRILL TEMPLATE 24200883 1
2 AC7DC XG TIMER (2) CONTROL BOARD 39200306 7
2 AC/DC XG TIMER (2) CONTROL BOARD US 39200307 7
3 AC/DC XG TIMER (3) SPIRAL CABLE 32000325.C 32000325 1
KIT SPIRAL CABLE + LOCAL BUTTON 29701028.C COMPLETE
AC/DC XG TIMER (4) DOUBLE LENGHT
4 32000359 1
SPIRAL CABLE
KIT DOUBLE LENGHT SPIRAL CABLE +
29701029.C COMPLETE
EXPOSURE BUTTON
AC/DC XG TIMER (5) EXPOSURE BUTTON
5 29700974.C 4
CASE
AC/DC XG TIMER (6) ESPOURE BUTTON
6 39700303 1
BOARD
7 AC/DC XG TIMER (7) LED BOARD 39200313 7
8 AC/DC XG TIMER (8) KEYBOARD DEG 39200510 39200308 1
8 AC/DC XG TIMER (8) KEYBOARD SAT 39200309 1
9 AC/DC XG TIMER (9) BOTTOM TIMER CASE 29700975.C 29700975 1
AC/DC XG TIMER (10) TOP TIMER CASE
10 29700304.C 29700304 4
DEG
10 AC/DC XG TIMER (10) TOP TIMER CASE SAT 29700976.C 29700976 4
11 AC/DC XG TIMER (11) SECURITY KEY SET 39700305 2
12 DC XG TIMER (12) EMI FILTER 36200382 3
13 BIPOLAR GREEN SWITCH 35000044 1
14 BIPOLAR SWITCH COVER 33500228 1

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SPARE PARTS PANTOGRAPH TYPE ARM CODE


REF OLD COLOR Q.TY PCS
x-mind ac® (RAL 9010 color)
1 AC XG B (1) CABLE + 3 POLES CONNECTOR 39700384 1
2 DC XG B (2) CABLE + 5 POLES CONNECTOR 39700381 1
3 AC/DC XG B (3) COVER SET TUBEHEAD SIDE 29700990.C 29700990 9
PANTOGRAPH ARM ANTERIOR TIE-BEAM
4 29700460 4
(2 pz)
PANTOGRAPH ARM ANTERIOR TIE-BEAM
5 29700458 6
HOLDER
6 AC/DC XG B (6) PLASTIC SCREW CAP SET 29700991.C 29700991 7
7 AC/DC XG B (7) EXTENAL COVER 27500757.C 27500757 1
8 AC/DC XG B (8) INTERNAL COVER 27500758.C 27500758 1
9 AC/DC XG B (9) ELBOW COVER 29700993.C 29700993 8
PANTOGRAPH ARM ALLEN WRENCH
10 22000543 1
LOADING KEY
11 AC/DC XG B (11) INTERNAL COVER 27500758.C 27500758 1
12 AC/DC B (12) ESTERNAL COVER 27500757.C 27500757 1
PANTOGRAPH ARM POSTERIOR TIE-BEAM
13 29700992 7
(2 pz)
14 AC/DC XG B & HALF-MOON LOCKER 22000176 1
15 AC/DC B (15) COVERS BRACKET SIDE 29700994.C 29700994 8

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CODE
REF SPARE PARTS WALL PLATE 350 OLD COLOR Q.TY PCS
(RAL 9010 color)
1 PLATE (1) COVER DEG 29700985.C 29700985 5
1 PLATE (1) COVER SAT 29700986.C 29700986 5
2 AC/DC XG B & HALF-MOON LOCKER 22000176 1
3 PLATE (3) DRILL TEMPLATE 24200984 1
PIASTRA (4) PLASTIC JOINT + PLASTIC
4 29701036.C 29701036 3
CAPS
WALL PLATE 350 DEG 29700383.C 29700383 COMPLETE
WALL PLATE 350 SAT 29700384.C 29700384 COMPLETE

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CODE
REF SPARE PARTS WALL PLATE 350 OLD COLOR Q.TY PCS
(RAL 9010 color)
1 PLATE (1) COVER DEG 29700985.C 29700985 5
1 PLATE (1) COVER SAT 29700986.C 29700986 5
2 AC/DC XG B & HALF-MOON LOCKER 22000176 1
3 PLATE (3) TOP MOUNT DRILL TEMPLATE 24201002 1
PIASTRA (4) PLASTIC JOINT + PLASTIC
4 29701036.C 29701036 3
CAPS
5 PIASTRA (5) TOP MOUNT COLLAR 22000597
WALL PLATE 350 TOP DEG 29700988.C 29700988 COMPLETE
WALL PLATE 350 TOP SAT 29700385.C 29700385 COMPLETE

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CODE
REF SPARE PARTS BRACKET OLD COLOR Q.TY PCS
(RAL 9010 color)
BRACKET 400 29700380.C 29700380 COMPLETE
BRACKET 800 29700378.C 29700378 COMPLETE
BRACKET 1100 29700379.C 29700379 COMPLETE
1 BRACKET CAP COVER + SCREW RAL 9010 29701281.C 2
BRACKET SLIDE COVER AC/DC 14X1.4cm
2 27502305 3
RAL 9010
3 BRACKET ROTATION STOPPER 29701008 5

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CODE
REF SPARE PARTS BRACKET OLD COLOR Q.TY PCS
(RAL 9010 color)
CIELING BRACKET 29700382.C 29700382 COMPLETE

CODE
REF SPARE PARTS BRACKET OLD COLOR Q.TY PCS
(RAL 9010 color)
DENTAL CHAIR BRACKET 29700381.C 29700381 COMPLETE

CODE
REF SPARE PARTS BRACKET OLD COLOR Q.TY PCS
(RAL 9010 color)
TOP MOUNT BRACKET 400 29700620.C 29700620 COMPLETE
TOP MOUNT BRACKET 800 29700621.C 29700621 COMPLETE
TOP MOUNT BRACKET 1100 29700622.C 29700622 COMPLETE

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A1
ANNEX 1
A1. TECHNICAL SPECIFICATIONS

X-ray SOURCE ASSEMBLY

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


Total filtration at 70 kV 2,3 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 0,080 s ≤ t ≤ 0,320 s
X-ray emission time accuracy
±5% 0,400 s ≤ t ≤ 3,2 s
Reproducibility 0,05
Generator Single phase X-ray generator
X-ray tube nominal current 8 mA
X-ray tube nominal voltage 70 kV
Exposure times 0,080 s ÷ 3,2 s
Reference current-time product 0,8 mAs 8 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
in one hour

PLEASE NOTE

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

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HEATING AND COOLING CURVES

X-ray TUBE

X-ray tube model TOSHIBA DG-073-AC


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

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

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DEVICE POWER SUPPLY

Type of power supply single phase, alternate


Supply nominal voltage 115 V / 220V / 230V
Maximum voltage variation ±10%
3,5 A @ 220V / 230V
Nominal current
5,7 A @ 115V
Supply voltage frequency 50/60 Hz
Maximum line current (measured @ 70 kV, 8 mA, 3,2 s) 5,7 A @ 115V
0,8 kVA at 230V
Absorbed power 0,79 kVA at 220V
0,66 kVA at 115V
0,5 Ω at 220V / 230V
Apparent resistance
0,2 Ω at 115V
F 8 A – 250 V at 220V / 230V
Protection fuses (F1 – F2 – F3 – F4)
F 12,5 A – 250 V at 115V
(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

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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

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A2
ANNEX 2
A2. INTENDED ENVIRONMENT

CAUTION

“x-mind ac®” is for INDOOR USE ONLY.


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

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

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A3
ANNEX 3
A3. LIST OF INTERNATIONAL STANDARDS AND DIRECTIVES

“x-mind ac®”: X-ray equipment for dental intraoral radiography, is in compliance with the following:

• MDD 93/42 EEC and subsequent amendments


In compliance with the classification indicated in the Medical Device Directive 93/42/EEC, Annex IX, article 10:
“Active devices intended to emit ionizing radiation and intended for diagnostic radiology”, the system is classified
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

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A4
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)


70 2,0 2,3

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%.

Cone type Circular Long Short Circular Rectangular Long


SSD (mm) 310 200 310
kV 70 70 70
mA 8 8 8
Time (s) DAP (mGy*cm2) DAP (mGy*cm2) DAP (mGy*cm2)
0,08 5,559 13,597 3,458
0,1 6,949 16,996 4,323
0,125 8,686 21,246 5,403
0,16 11,118 27,194 6,916
0,2 13,897 33,993 8,646
0,25 17,372 42,491 10,807
0,32 22,236 54,388 13,833
0,4 27,795 67,986 17,291
0,5 34,744 84,982 21,614
0,63 43,777 107,077 27,234
0,8 55,590 135,971 34,582
1 69,487 169,964 43,228
1,25 86,859 212,455 54,035
1,6 111,179 271,942 69,165
2 138,974 339,928 86,456
2,5 173,718 424,910 108,070
3,2 222,358 543,885 138,329

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A5
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 ac®” is intended to be used in the electromagnetic environment specified below. The customer or the
operator of “x-mind ac®” must ensure that the device is used in this type of environment.
Electromagnetic
Emission test Conformity
environment guidance
“x-mind ac®” 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 ac®” 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

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Guidance and manufacturer’s declaration – electromagnetic immunity


“x-mind ac®” is intended to be used in the electromagnetic environment specified below. The customer or
“x-mind ac®” operator must ensure that the device is used in this type of environment.
Electromagnetic
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
ac®” 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.

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Guidance and manufacturer’s declaration – electromagnetic immunity


“x-mind ac®” is intended to be used in the electromagnetic environment specified below. The customer or
“x-mind ac®” operator must ensure that the device is used in this type of environment.
CEI EN 60601 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 ac®”, 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 ac®”.
b - Over the frequency range between 150 kHz and 80 MHz, the field strength must be below 10 V/m.

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Recommended separation distances between portable and mobile RF communication equipment


and “x-mind ac®” medical device
These devices are intended to be used in environments where radiated RF interference is controlled. The
customer or “x-mind ac®” operator can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communication equipment (transmitters) and “x-mind ac®”, as
indicated below, according to the maximum output power of the communication equipment.
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.

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A6
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

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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 ac®” exists also in the mobile version and it is sustained by the stand shown in the following figure:

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

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A7
ANNEX 7
A7. INSTALLATION ELECTRICAL SCHEME

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Réf. W1100201 - 02/2016 - Non contractual document - Copyright © 2015 DEGOTZEN. All rights reserved. No information or part of this document may be reproduced or transmitted in any form without the prior permission of DEGOTZEN.

de Götzen S.r.l • A company of ACTEON Group


Via Roma 45 • 21057 OLGIATE OLONA (VARESE) • ITALY
Tel +39 0331 376 760 • Fax +39 0331 376 763
E-mail: info.italia@acteongroup.com
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