INSTALLATION &
MAINTENANCE MANUAL
INSTALLATION & MAINTENANCE MANUAL • XMIND DC • W1100100 • V1 • (15) • 12/2015 • NXDCEN020B
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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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FRANCE
SATELEC ACTEON GROUP
17 avenue Gustave Eiffel - B.P. 30216 33708 Mérignac-Cedex, FRANCE
Tel: +33 (0)5.56.34.06.07 - Fax: +33 (0)5.56.3492.92 E-mail: satelec@acteongroup.com
GERMANY
ACTEON GERMANY GmbH
Industriestrasse 9 D-40822 Mettmann, GERMANY
Tel: +49 (0)2104/9565-10 - Fax: +49 (0)2104/9565-11
E-mail: info@de.acteongroup.com
SPAIN
ACTEON MEDICO-DENTAL IBERICA S.A.U.
Polígono Industrial Can Clapers - Avda. Principal 11H - Sentmenat, 08181 Barcelona, SPAIN
Tel: +34 93 715 45 20 - Fax: +34 93 715 32 29
E-mail: info@es.acteongroup.com
U.K.
ACTEON UK
Unit 1B - Steel Close - Eaton Socon – St. NEOTS Cambs - PE19 8TT, UNITED KINGDOM
Tel : +44 (0)1 480477 307 - Fax: +44 (0)1 480477 381
E-mail: info@uk.acteongroup.com
USA
ACTEON Inc.
124 Gaither Drive, Suite 140 Mount Laurel, NJ 08054, USA
Tel:+1 8562229988 - Fax:++ 1 8562224726
E-mail: info@us.acteongroup.com
SOUTH AMERICA
ACTEON LATIN AMERICA
Bogotà - COLOMBIA
Celular: +57 312 377 8209
e-mail : carlosandres.vera@es.acteongroup.com
RUSSIA
ACTEON RUSSIA
Valdajski Proezd 16 – office 253 - 125445 Moscow - RUSSIA
Tel./Fax. +7 499 76 71 316
e-mail : sergey.koblov@ru.acteongroup.com
THAILAND
ACTEON THAILAND LTD
23/45 Sorachai Building 16th floor - Sukumvit 63 Road, Klongton Nua - Wattana, BANGKOK
10110 - THAILAND
Tel. +66 2 714 3295 - Fax. +66 2 714 3296
e-mail : info@th.acteongroup.com
CHINA
ACTEON CHINA
Office 401 - 12 Xinyuanxili Zhong Street - Chaoyang District - BEIJING 100027 - CHINA
Tel. +86 10 646 570 11/2/3 - Fax. +86 10 646 580 15
e-mail : beijing@cn.acteongroup.com
TAIWAN
TAIWAN (R.O.C.)
14F.-1, No.433, Jingping Rd. Jhonghe Dist., New Taipei City 23563
Tel: +886 926 704 505
E-mail: tina.chu@tw.acteongroup.com
KOREA
ACTEON KOREA Corp.
8F Hanil B/D - 132-4 1Ga Bongrae-dong - JOONG-GU – SEOUL - KOREA
Tel. +82 2 753 41 91 - Fax. +82 2 753 41 93
e-mail: info@kr.acteongroup.com
INDIA
ACTEON INDIA
B-94, GIDC Electronic Estate - Sector 25 – GANDHINAGAR 382028 Gujarat - INDIA
Tel. +91 79 2328 7473 - Fax. +91 79 2328 7480
e-mail: info@in.acteongroup.com
MIDDLE EAST
ACTEON MIDDLE EAST
Numan Center - 2nd Floor N° 205 - Gardens Street - PO Box 5746 - 11953 AMMAN - JORDAN
Tel. +962 6 553 4401 - Fax. +962 6 553 7833
e-mail : info@me.acteongroup.com
AUSTRALIA
NEW ZEALAND
ACTEON AUTRALIA/NEW ZEALAND
Suite 119, 30-40 Harcourt Parade, Rosebery NSW 2018 - Australia
Tel. +612 9669 2292 - Fax. +612 9662 2204
e-mail : sandy.junior@au.acteongroup.com
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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 “Xmind®dc” IN ANY FORM
WITHOUT PRIOR WRITTEN CONSENT BY de GÖTZEN® S.r.l. – ACTEON Group.
THE MANUAL MUST ALWAYS BE KEPT NEAR THE MEDICAL DEVICE FOR FUTURE REFERENCE.
de Götzen® S.r.l. – ACTEON Group SHALL NOT BE LIABLE FOR AN INCORRECT USE OF THE
INFORMATION CONTAINED IN THIS MANUAL.
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CONTENTS
CHAPTER 1.......................................................................................................................................... 7
1.1. PRELIMINARY INFORMATION............................................................................................................ 7
1.2. INFORMATION FOR THE INSTALLER................................................................................................. 7
1.3. WARRANTY CONDITIONS................................................................................................................... 8
1.4. TRANSPORT CONDITIONS.................................................................................................................. 8
1.5. SAFETY WARNINGS.............................................................................................................................. 9
CHAPTER 2........................................................................................................................................ 13
2.1. RADIOGRAPHIC SYSTEM...................................................................................................................13
2.2. SYSTEM COMPONENTS.....................................................................................................................14
2.3. OVERALL DIMENSIONS.....................................................................................................................15
2.4. IDENTIFICATION TAGS......................................................................................................................18
CHAPTER 3........................................................................................................................................ 21
3.1. INSTALLATION SPECIFICATIONS......................................................................................................21
CHAPTER 4........................................................................................................................................ 23
4.1. INSTALLATION....................................................................................................................................23
4.2. UNPACKING........................................................................................................................................23
4.3. ASSEMBLING THE WALL PLATE........................................................................................................24
4.4. ASSEMBLING THE BRACKET.............................................................................................................25
4.5. ASSEMBLING THE PANTOGRAPH ARM...........................................................................................26
4.6. ASSEMBLING THE TIMER..................................................................................................................27
4.7. ASSEMBLING THE TUBEHEAD..........................................................................................................28
4.8. BALANCING THE PANTOGRAPH ARM.............................................................................................30
CHAPTER 5........................................................................................................................................ 33
5.1. ELECTRIC CONNECTION...................................................................................................................33
CHAPTER 6........................................................................................................................................ 36
6.1. CONFIGURATION...............................................................................................................................36
6.2. CHANGING THE CONFIGURATION..................................................................................................37
CHAPTER 7........................................................................................................................................ 40
7.1. START UP.............................................................................................................................................40
CHAPTER 8........................................................................................................................................ 41
8.1. CHECKING THE INSTALLATION........................................................................................................41
8.2. CHECKING THE EXPOSURE FACTORS..............................................................................................42
CHAPTER 9........................................................................................................................................ 44
9.1. DIAGNOSTIC.......................................................................................................................................44
CHAPTER 10...................................................................................................................................... 46
10.1. CALIBRATION OF THE TUBEHEAD.................................................................................................46
CHAPTER 11...................................................................................................................................... 47
11.1. ERROR MESSAGES...........................................................................................................................47
CHAPTER 12...................................................................................................................................... 49
12.1. SUGGESTED MAINTENANCE..........................................................................................................49
12.2. CLEANING THE OUTER SURFACE...................................................................................................49
CHAPTER 13...................................................................................................................................... 51
13.1. REPLACEMENT OF FUSES................................................................................................................51
CHAPTER 14...................................................................................................................................... 53
14.1. REPAIR...............................................................................................................................................53
13.2. DISPOSAL..........................................................................................................................................53
CHAPTER 15...................................................................................................................................... 54
15.1. SPARE PARTS....................................................................................................................................54
ANNEXES.......................................................................................................................................... 65
A1. TECHNICAL SPECIFICATIONS............................................................................................................65
ANNEX 2........................................................................................................................................... 68
A2. INTENDED ENVIRONMENT................................................................................................................68
ANNEX 3........................................................................................................................................... 69
A3. LIST OF INTERNATIONAL STANDARDS AND DIRECTIVES..............................................................69
ANNEX 4........................................................................................................................................... 70
A4. DOSIMETRIC INDICATIONS...............................................................................................................70
ANNEX 5........................................................................................................................................... 73
A5. ELECTROMAGNETIC COMPATIBILITY...............................................................................................73
ANNEX 6........................................................................................................................................... 77
A6. DRAWINGS AND DIMENSIONS.........................................................................................................77
ANNEX 7........................................................................................................................................... 79
A7. INSTALLATION ELECTRICAL SCHEME...............................................................................................79
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CONTROL PANEL
MAIN SWITCH
CONTROL BUTTON
DISPLAY
X-RAY KEY
RADIOGRAPHIC DISTANCE
INDICATOR
KEY TO DECREASE
EXPOSURE TIME
KEY TO INCREASE
EXPOSURE TIME
TUBEHEAD TYPE
INDICATOR
TEBEHEAD SELECTION
SELECTION OF TYPE OF
PATIENT’S PHYSIQUE
RADIOGRAPHIC VOLTAGE
INDICATOR
MEMORY
RADIOGRAPHIC CURRENT
INDICATOR
MAXILLARY LOWER
TEETH
OCCLUSAL EXAM
MANDIBULARY LOWER
TEETH
BITE-WING EXAM
X-RAY OUTPUT SIGNAL
DIGITAL RADIOGRAPHIC
TECHNIQUE
PAUSE INDICATOR
MALFUNCTIONING
INDICATOR
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KEY SWITCH
CONVENTIONAL
RADIOGRAPHIC TECHNIQUE
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1
CHAPTER 1
1.1. PRELIMINARY INFORMATION
Before beginning to use the “Xmind®dc” radiographic system, it is mandatory to carefully read and follow the
instructions contained herein, so as to obtain the best possible performance and to assure the safety of the
patient, operator, device and environment.
Always pay close attention to the
CAUTION
WARNING
PLEASE NOTE
messages when operating the system.
LEGEND
CAUTION
The word CAUTION 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 “Xmind®dc” radiographic system it is advisable to:
- check that the voltage mentioned in the rating plate matches the line voltage;
- install the radiographic system according to the procedures described in this manual;
- provide the user with any information regarding the use of the radiographic system according to what stated
in the manual;
- certify the work done by a “Declaration of Conformity;
- return to “de Götzen® S.r.l.” the warranty 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 “Xmind®dc” radiographic system, from any service under warranty or from any other
liability.
The warranty is valid only if the following precautions are taken:
- any repairs, modifications, adjustments, re-calibrations 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 “Xmind®dc” for reference.
- in case of repair, please use only spare parts from the manufacturer of the “Xmind®dc”. Otherwise basic safety
and essential performances of the device will not be guaranteed.
de Götzen® S.r.l. – ACTEON Group is not responsible for any damages caused by any person or thing as
a consequence of non-compliance of any or all guidelines contained in all the manuals provided with the
“Xmind®dc” device.
CAUTION
Non compliance of any of the above mentioned rules and all the indications provided by the manufacturer in the documentation, or successively
in written paper or electronic format, will result in losing the warranty of the product and the manufacturer will be discharged from any obligation, including consequential damages, direct or indirect that may derive to people, things or environment. Furthermore, the facility representative, customer or employees of the facility, will be liable for any damage and/or incident and/or degeneration of the health status of a patient,
operator, involved people and the surrounding environment.
1.4. TRANSPORT CONDITIONS
The “Xmind®dc” radiographic system travels at the receiver’s own risk.
All claims for damage or miscarriage regarding the shipment must be pointed out in the presence of the shipping
agent.
In case of miscarriages, or actual or suspected damage, the receiver shall indicate the proper reserves on the
way-bill or on the consignment note.
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1.5. SAFETY WARNINGS
A few safety recommendations which should be followed when using the “Xmind®dc” radiographic system are
listed here below.
CAUTION
GENERAL REQUIREMENTS
GENERAL REQUIREMENTS
RESPONSIBLE ORGANIZATION is the authority that has the responsibility for the USE and MAINTENANCE of the “Xmind®dc” radiographic system.
The training and preparation of personnel is the responsibility of THE RESPONSIBLE ORGANIZATION.
“Xmind®dc” radiographic system is an X-ray generator and must be used and handled only by specialised surgeons, dentists and authorized
personnel, who meet the requirements provided by the national laws in force in the country of installation.
It is mandatory for the RESPONSIBLE ORGANIZATION to provide a routine and special maintenance schedule for medical equipment; this 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 “Xmind®dc” radiographic system operation (IEC
60601-1 etc.). These operations must be carried out according to the methods and frequency indicated in this manual and in the installation and
maintenance manual. Failure to comply with this requirement or with the messages concerning anomalies will release the manufacturer from
any liability for direct and indirect injuries to persons and/or damage to property or the environment. Furthermore, the managers of the facility,
customers or collaborators shall be held liable for any damage and/or accidents and/or degeneration of patients’ or operators’ health or of the
surrounding environment.
The RESPONSIBLE ORGANIZATION must also provide for the safe and proper use of the equipment.
(*) For Italy refer to Presidential Decree 14/01/1997, Legislative Decree No. 81/2008 (as subsequently amended and 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.
“Xmind®dc” radiographic system has been designed to acquire radiography images for dental intraoral X-ray imaging. The “Xmind®dc” medical
device must not be used for X-ray imaging of other body parts.
Carefully follow the instructions in this manual to install, operate and maintain the “Xmind®dc” radiographic system. In the event that local laws
and standards are more restrictive than the manufacturer’s indications, the former supersede the latter.
The RESPONSIBLE ORGANIZATION must comply with the standards and regulations in force concerning the installation of the medical device in
consideration of the place of installation.
The operator is cautioned to monitor the patient and the parameters of the “Xmind®dc” radiographic system throughout the entire duration of
the X-ray examination.
It is prohibited to modify any part of the “Xmind®dc” medical device.
de Götzen S.r.l. – ACTEON Group and its authorized technicians are not required to verify compliance of the installation site with local standards
concerning electrical safety and X-ray protection and with any other directive concerning safety in force in the country of installation.
The RESPONSIBLE ORGANIZATIONS of the facility must ensure compliance of the installation site with the local laws in force.
Before each examination, it is mandatory to apply a disposable protection sheath to the collimator cone (Beam Limiting Device) designed to
cover the end part of the X-ray unit, which is more susceptible of being directly contaminated during the X-ray exposure (class I Medical Device
Directive 93/42/EEC and subsequent amendments). It can come into contact with the patient’s skin: verify biocompatibility according to the principles given in the ISO 10993 series of standards, refer for details to the disposable use protection’s instructions for use.
Before operating the “Xmind®dc” radiographic system the operator must assure that the device has no visible signs of damage.
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CAUTION
PROTECTION AGAINST RADIATIONS
PROTECTION AGAINST RADIATIONS
“The general principles regarding safety and protection of workers and people” must always be applied when using the unit:
1. Justification of the practice
2. Protection Optimisation
3. Reduction of the limits of individual dose and risks
The “Xmind®dc” is a medical device that generates X-rays; therefore, both the patients and the operator are exposed to risks due to ionizing
radiation. The physician must assess the actual need for X-ray exposure.
All personnel present during an X-ray examination must comply with safety regulations concerning protection against radiation. For their own
safety, the operator must always keep a distance of more than 2 meters (6 ft.) and out of the path of the X-ray beam, in order to avoid the exposition to the stray radiation and residual radiation.
The “Xmind®dc” medical device must be used in compliance with the local standards in force and with the international directives concerning
radiation protection.
The device must comply with the guidelines and indications provided by an accredited specialist in radiation protection, who will recommend, if
necessary, the additional shields or precautions for every 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 “Xmind®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 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 “Xmind®dc” do not
interfere with its functionality.
.
“Xmind®dc” generates X-rays: Before using this X-ray system please refer to the regulation in force in your area concerning paediatric patients,
pregnant women and anyone with health issues that contraindicate the use of X-rays. Investigate and make sure of this condition before starting
the exposure.
This symbol indicates X-ray hazard.
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CAUTION
MECHANICAL RISK
Before removing the tubehead from the positioning arm, RELEASE THE SPRING.
The sudden opening of the joint may cause damage to people and/or things.
Check that the installation of the unit complies with the mechanical 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 “Xmind®dc” must not be used in environments or close to environments subjected to mechanical vibrations or mechanical shocks.
CAUTION
ELECTRIC SAFETY
The radiographic system contains high voltage. It is prohibited to inspect internal parts of the system.
Never attempt to open the X-ray tubehead.
The covers on the “Xmind®dc” radiographic system must only be removed by 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 equipment located inside the patient environment. In particular such a Separation Device is required when a network or data connection is made. The
requirements on the Separation Device is defined in CEI EN 60601-1, edition 3, clause 16.
For the wall version of “Xmind®dc”:
based on the CEI EN 60601-1, the installation is a permanent type (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 “Xmind®dc” must be installed and used accordingly to 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 “Xmind®dc” radiographic system guarantees the maximum safety both for the operator and the patient.
It is built in compliance with the following European Directives:
} 93/42/EEC and subsequent amendments MEDICAL DEVICES
} EURATOM 96/29 IONISING RADIATIONS
and in compliance with the following American Standard:
} American Radiation Performance Standard 21 CFR, Subchapter J, Sec. 1020.30 and 1020.31
The following protective measures were adopted in the design and construction of the unit:
- protection against the risk of electric injuries, ensured by a grounded protection conductor
- protection against leakage radiation, made negligible by the shielded casing
- protection against excessive radiations, thanks to the immediate activation of the safety device
- protection against continuous service, since the system is designed, according to standards, not to allow use
in radioscopy
- protection for the patient against dangerous radiations, obtained by means of the high frequency technology
capable of producing a constant and hard radiation
- protection against exposure mistakes obtained with the high frequency technology which is unaffected by
voltage 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 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
“Xmind®dc” radiographic system (Fig. 1) consists of:
1. “Xmind®dc” TIMER
The timer is the control panel used to manage the exposure times and to safely use the tubehead.
To make the exposure, the control button with safety key is available.
The timer can be connected to n° 2 dc tubeheads.
2. WALL PLATE
3. BRACKET
The horizontal bracket is available in 3 different lengths (110 cm, 80 cm, 40 cm) and represents the support for
the pantograph arm. Its shaft is 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 “Xmind®dc”
The intra-oral “Xmind®dc” is a tubehead type and its light alloy housing is divided into two compartments.
The high voltage transformer, the X-ray tube and the expansion chamber are submerged in highly dielectric
insulating oil inside a light alloy container.
The expansion chamber guarantees an adequate compensation to oil expansion for the entire temperature
range.
The X-ray tube is located in the back part of the container, allowing a source-skin distance 50% higher than
traditional structures.
In the second compartment the main electronic board and the control electronic board are placed.
6. CONE
The collimator cone or Beam Limiting Device represents the applied part of the device. Made of the transparent
polycarbonate, it allows:
- the correct distance between focal spot and skin
- dimension, direction and centering of X-ray beam
- the realization of different radiographic technique (bisecting and parallel technique).
During X-ray exposition, the collimator cone comes in contact with the skin of the patient. Before each exam, it is
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necessary to apply to the cone a disposable protective cover designed to cover the end part of the X-ray generator.
Such protection has two functions: avoid cross-contamination (from patient to patient) and prevent the possibility 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
}Xmind®dc LIGHT (Rx signalling lamp for external use)
}Xmind®dc ECB (remote control button)
PLEASE NOTE
For the installation of the optional accessories, refer to the specific installation manuals supplied.
2.3. OVERALL DIMENSIONS
Fig. 2A, 2B, 2C give the overall dimensions of the possible supply conditions:
BRACKET 400: L = 16” 9/64
BRACKET 800: L = 82,5cm – 32” 31/64
BRACKET 1100: L = 110cm – 43” 5/16
BRACKET 400
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BRACKET 800
BRACKET 1100
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Fig. 3 and 4 show the typical dimensions of the radiographic system:
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2.4. IDENTIFICATION TAGS
The 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 115 V
2.3.2. TIMER
Model 230 V
Model 115 V
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CONE
GRADUATED SCALE
PICTOGRAMS USED
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SYMBOL INDICATING THE MANUFACTURER
THIS SYMBOL GUARANTEES THAT THE RADIOGRAPHIC SYSTEM COMPLIES WITH THE
REGULATIONS CONTAINED IN THE EUROPEAN DIRECTIVE EEC 93/42 REGARDING MEDICAL
DEVICES
SIZE OF THE FOCAL SPOT
THE DEGREE OF PROTECTION AGAINST DIRECT AND INDIRECT ELECTRIC CONTACTS IS B
TYPE
SYMBOL INDICATING THE SERIAL NUMBER
SYMBOL INDICATING DANGER DUE TO IONISING RADIATIONS
X-ray EMISSION (IEC 60417)
PAUSE (IEC 60417)
ATTENTION, REFER TO THE ATTACHED DOCUMENTS
REFER TO MANUAL’S INSTRUCTIONS
WEEE (Waste Electrical and Electronic Equipment) SYMBOL, IN CONFORMITY WITH 2012/19/
CE DIRECTIVE AND EN 50419 STANDARD.
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3
CHAPTER 3
3.1. INSTALLATION SPECIFICATIONS
! WARNING
Prior to installing the radiographic system the Office Owner must ascertain 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 200 Kg tear at every fixing point.
PLEASE NOTE
It is mandatory to check the nature and consistency of the wall; 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
ELECTRIC SYSTEM
230 V ± 10%
115 V ± 10%
NOMINAL VOLTAGE
230 V
115 V
MINIMUM LINE VOLTAGE
207 V
103,5 V
MAXIMUM LINE VOLTAGE
253 V
126,5 V
FREQUENCY
50 / 60 Hz
50 / 60 Hz
ABSORBED POWER
1,2 kVA
1,1 kVA
REQUIREMENTS OF THE ELECTRIC LINE
- The electric line must be “single phase alternate” type.
- It is essential a 16A – 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, and must bear suitable section to the length of the power supply line (Chart B).
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Chart B
MANUFACTURER’S RATING PLATE
230 V ± 10%
115 V ± 10%
POWER SUPPLY VOLTAGE
198 ≤ V ≤ 253
103,5 ≤ V ≤ 126,5
MINIMUM CONDUCTOR SECTION
MAXIMUM LINE LENGHT
1,5 mm2
10 m
MAXIMUM CONDUCTOR SECTION
MAXIMUM LINE LEGHT
2,5 mm2
20 m
PLEASE NOTE
For longer lines, the conductor section must be increased in proportion.
- The communication cables (C11, C12 – C21, C22) between the timer and the tubehead must be two-pole, twisted
and shielded with 0,25mm2 (es. tipo Belden 9501).
- The cables (S11, S12 – S21, S22) connecting the timer and the Rx signalling lamp for external use must be twopole type, of section 0,5mm2.
- The electric line characteristics must (Chart C).
Chart C
MANUFACTURER’S RATING PLATE
ELECTRICAL LINE
230 V ± 10%
MAXIMUM VOLTAGE DROP
APPARENT LINE RESISTANCE
115 V ± 10%
3%
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, suitable runs for the following electric cables must be provided, according to the
installation electric diagram (refer to Chapter 15):
} timer electric cables;
} cables for the connection between timer and tubehead;
} cables connecting the timer and the X-ray signalling lamp for external use Xmind® LIGHT (OPTIONAL);
} cables connecting the timer and the remote control button Xmind® ECB (OPTIONAL).
CAUTION
According to the relevant standard, the timer must be installed in a position that allows the operator to permanently control the radiographic
exposure.
TUBEHEAD
On the wall plate installation wall, a suitable run for the cable connecting the timer and tubehead must be
provided.
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4
CHAPTER 4
4.1. INSTALLATION
CAUTION
The “Xmind®dc” radiographic system must be installed by professionally trained technicians, who must be able to certify their work by
“Declaration of Conformity”.
! WARNING
Prior to installing the radiographic system, it is advisable to verify that all needed requirements have been met (refer to Chapter 3)
4.2. UNPACKING
The components of the “Xmind®dc” 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 2,5 mm.
! 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).
Fig. 6
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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.
2.
3.
Take out the bracket from the packaging.
Insert the bracket pin 3 into the wall plate 1 (upwards).
Insert the supporting rest 2.
Fig. 8
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 specifications (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 do as 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 the timer out of the packaging and take out 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 out the tubehead from the packaging.
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 when the tubehead is assembled only (Fig. 12).
! WARNING
To prevent damages to the internal mechanism while performing adjustment and the 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.
BRACCIO A – ARM A
BRACCIO B – ARM B
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INSTRUCTION (refer to Fig. 12)
1. BALANCING THE ARM A
PLEASE NOTE
The pantograph type 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 malfunctioning.
CONNECTION INSTRUCTION TO THE FEEDING TERMINAL BOARD
1. Remove the terminal board cover 1 by unscrewing the fixing screw 2.
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2. Proceed to the electric connection as shown:
TERMINAL BOARD CONNECTION DIAGRAM
1
BROWN
L = PHASE
2
YELLOW GREEN
T = GROUND
3
BLUE
N - NEUTRAL
4
BLACK
COMMUNICATION
5
RED
COMMUNICATION
6
YELLOW GREEN
T = GROUND
7
YELLOW GREEN
T = GROUND
THE COMMUNICATION CABLES ARE NOT POLARIZAED
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 INSTRUCTION TO THE TIMER
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
Connect the power supply cable to the terminal board α.
Insert the three mains cables into the rack.
Fix them with the cable clamp β.
Connect the cables coming from the tubehead 1 to the terminals XRAY1.
Connect the communications cables from the tubehead 1 to the terminals C11 and C12.
Connect the yellow-green grounding cable to the equipotential metal plate δ.
Connect the cables coming from the tubehead 2 to the terminals XRAY2.
Connect the communications cables from the tubehead 2 to the terminals C21 and C22.
Connect the yellow-green grounding cable to the equipotential metal plate δ.
Clamp the cables in the cable clamp γ.
Connect the Rx signalling lamps for external use (OPTIONAL).
Connect the remote control buttons (OPTIONAL).
Check the configuration on the dip-switches.
Reconnect the 26-pole connector.
Close the timer with the three screws.
Mount the sliding cover and the plug of the. wall plate
Reconnect the power supply.
1
TUBEHEAD 1 CONTROL BUTTON
2
TUBEHEAD 2 CONTROL BUTTON
OPTIONAL
3A
TUBEHEAD 1 RX SIGNALLING LAMP
OPTIONAL
3B
TUBEHEAD 2 RX SIGNALLING LAMP
OPTIONAL
4A
RS232 COMMUNICATION FOR TUBEHEAD 1
4B
RS232 COMMUNICATION FOR TUBEHEAD 2
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 “Xmind®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 tubehead
LED DC = DIRECT 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 DC
3
■
TUBEHEAD 2
4
■
TUBEHEAD DC
5
6
■
■
II° CONTROL BUTTON
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 DC
3
■
TUBEHEAD 2
4
■
TUBEHEAD DC
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
►radiographic voltage (60kV/70kV)
►radiographic current (4mA/8mA)
►type of patient (ADULT/CHILD)
(refer to “User’s Manual” Chapter 4)
Possible modifications of the exposure values
►cone (8” /12”)
►type tubehead
► N° of control button
inside the timer, by changing the dip-switch position
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THIS OPERATION MUST BE CARRIED OUT BY THE INSTALLER ONLY
DIP SWITCH
ON
OFF
PARAMETER
1
INSTALLED
NOT INSTALLED
2
dc
ac
3
INSTALLED
NOT INSTALLED
4
dc
ac
5
INSTALLED
NOT INSTALLED
II° CONTROL BUTTON
6
LONG 12’’ = 30cm
SHORT 8’’ = 20cm
CONO
TUBEHEAD 1
TUBEHEAD TYPE 1
TUBEHEAD 2
TUBEHEAD TYPE 2
7
NOT AVAILABLE
8
NOT AVAILABLE
INSTRUCTION
To change the number of 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 of 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 of 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 Xmind®dc 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 relevant button.
To change the cone installed, move the dip-switch 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:
- an intermittent sounds off (beep);
- MALFUNCTIONING INDICATOR LED
intermittently turns on
- the error code (E ….) appears on the display (refer to Chapter 11)
- all control panel functions are inhibited;
In this case turn off the timer and then turn it back on.
If the error should repeat itself, 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
the yellow
LED turns off.
X-RAY key and keep it pressed until the acoustic signal (beep) stops and
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 “Xmind®dc” complies with the requirements when:
the absorbed current is 5.2A±10% at 230V
the absorbed current is 9.5A±10% a 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 is ≤ 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
radiations.
STEP 1 : Checking the radiographic voltage (kVp)
The radiographic voltage is measured using a calibrated “no invasive” instruments.
SET TECHNICAL FACTORS
NOMINAL VOLTAGE
Vn ± 10%
MAXIMUM VOLTAGE DROP
3%
NOMINAL HIGH VOLTAGE
60 / 70 kV
NOMINAL CURRENT
4 / 8 mA
SET EXPOSURE TIME
3,2 s
The radiographic voltage is 60kVp / 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
60 / 70 kV
NOMINAL CURRENT
4 / 8 mA
SET EXPOSURE TIME
1s
Dose in air is:
SOURCE-SKIN DISTANCE
31 cm = 12”
20 cm = 8”
60kVp - 4mA = 2,2mGy/s ± 30%
60kVp - 4mA = 4,5mGy/s ± 30%
70 kVp – 4mA = 3mGy/s ± 30%
70 kVp – 4mA = 6mGy/s ± 30%
60kVp - 8mA = 4,5mGy/s ± 30%
60kVp - 8mA = 9mGy/s ± 30%
70kVp - 8mA = 5,5mGy/s ± 30%
70kVp - 8mA = 12mGy/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
60 / 70 kV
NOMINAL CURRENT
4 / 8 mA
SET EXPOSURE TIME
3,2 s
The exposure time measured is 3,2s ±5% or ±20ms, whichever is larger.
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9
CHAPTER 9
9.1. DIAGNOSTIC
With “Xmind®dc” 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 0.02s.
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:
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KEY
DISPLAY PARAMETER
RADIOGRAPHIC SYSTEM
NOMINAL VOLTAGE
LINE VOLTAGE
SOFTWARE VERSION
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10
CHAPTER 10
10.1. CALIBRATION OF THE TUBEHEAD
CAUTION
During this operation there is X-ray output.
It is mandatory to adopt all the safety measures relevant to radioprotection.
INSTRUCTION
1. turn off the timer.
2. turn on the timer by keeping pressed the
key.
3. the message TUBE is displayed.
4. select with the
key the tubehead to calibrate.
5. take the exposure: on the control button press the
(beep) stops and the yellow
LED turns off.
X-RAY key and keep it pressed until the acoustic signal
6. once the exposure has been taken, if the display does not show errors, the calibration has been successfully
done.
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11
CHAPTER 11
11.1. ERROR MESSAGES
The following chart gives a list of error messages that may appear while “Xmind®dc” radiographic system is
working.
The chart also includes the causes of the error messages and what to do to solve them.
ERROR
MESSAGES
CAUSE
SOLUTION
E00
RX1 TUBEHEAD
IS NOT CONNECTED OR IS OUT OF ORDER
CALL THE “ASSISTANCE SERVICE”
E01
RX2 TUBEHEAD
IS NOT CONNECTED OR IS OUT OF ORDER
CALL THE “ASSISTANCE SERVICE”
E02
CORRUPTED EEPROM DATA
CALL THE “ASSISTANCE SERVICE”
E03
EEPROM DATA NOT SAVED PROPERLY
CALL THE “ASSISTANCE SERVICE”
E07
LINE VOLTAGE VALUE NOT INCLUDED
WITHIN THE NOMINAL VALUE
CALL THE “ASSISTANCE SERVICE”
E08
THE X-ray KEY
ALWAYS SEEMS TO BE PRESSED
MAKE SURE IT IS NOT JAMMED
E09
ANOMALY IN THE CONTROL PANEL
CALL THE “ASSISTANCE SERVICE”
E12
THE EXPOSURE
HAS BEEN PREMATURELY INTERRUPTED
KEEP THE X-ray KEY
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”
E24
THE CONTROL BUTTON DOES NOT CORRESPOND
CALL THE “ASSISTANCE SERVICE”
TO THE SELECTED TUBEHEAD
E30
THE TUBEHEAD
DOES NOT WORK PROPERLY
CALL THE “ASSISTANCE SERVICE”
E32
THE TUBEHEAD
IS NOT IN THE CORRECT MODE
CALL THE “ASSISTANCE SERVICE”
E33
THE TUBEHEAD
HAS NOT COMPLETED THE EXPOSURE
REPEAT THE EXPOSURE
CALL THE “ASSISTANCE SERVICE”
E40
PROBLEM IN THE FREQUENCY
OR REGULATION
CALL THE “ASSISTANCE SERVICE”
E41
THE TUBEHEAD
IS NOT CALIBRATED
CARRY OUT WITH THE CALIBRATION
CALL THE “ASSISTANCE SERVICE”
E42
EEPROM DATA NOT SAVED PROPERLY
CALL THE “ASSISTANCE SERVICE”
E43
CORRUPTED EEPROM DATA
CALL THE “ASSISTANCE SERVICE”
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E44
OVERVOLTAGE ERROR
CALL THE “ASSISTANCE SERVICE”
E45
ANODE VOLTAGE OUT OF TOLERANCE
CALL THE “ASSISTANCE SERVICE”
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”
ERR
MAJOR ERROR
ALL FUNCTIONS ARE DISABLED
CALL THE “ASSISTANCE SERVICE”
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12
CHAPTER 12
12.1. SUGGESTED MAINTENANCE
In order to guarantee the safety of the radiographic system, it is necessary to set up a maintenance schedule.
The owner is responsible for organising 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.
! 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”.
12.2. 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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13
CHAPTER 13
13.1. 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. Out 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
230 V ± 10%
115 V ± 10%
PROTECTION FUSES
8 AF – 250 V
12 AF – 250 V
7. Put in place the protection.
8. Close the timer guard.
9. Turn on the power supply.
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14
CHAPTER 14
14.1. 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 equipment. 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, don’t dispose the device and its accessories together with the domestic waste.
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15
CHAPTER 15
15.1. 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 “Xmind®dc” radiographic system which may be repaired.
REF
SPARE PARTS TUBEHEAD Xmind®
CODE
(RAL 9010 color)
OLD COLOR
Q.TY PCS
1
DC XG (1) FORK COVER
29700979.C
29700979
8
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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REF
SPARE PARTS Xmind® LIGHT
(OPTIONAL)
CODE
(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
3
4
XG LIGHT (4) ELECTRONIC BOARD 115V
39200353
3
X GENUS EXTERNAL LIGHT 230V KIT
COMPLETE KIT
5.15.00032
COMPLETE
X GENUS EXTERNAL LIGHT 115V KIT
COMPLETE KIT
5.15.00034
COMPLETE
OLD COLOR
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Q.TY PCS
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REF
SPARE PARTS Xmind® ECB
(OPTIONAL)
CODE
(RAL 9010 color)
1
XG ECB (1) COVER SET ING & SUP
29700978.C
4
2
CONTROL BOARD WITH PUSHBUTTON
AND LED
39700303
1
3
XG ECB (3) KEY SWITCH
35100298
1
COMPLETE KIT ECB REMOTE BUTTON
5.15.00033
COMPLETE
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OLD COLOR
Q.TY PCS
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REF
SPARE PARTS TIMER Xmind®
CODE
(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
KIT SPIRAL CABLE + LOCAL BUTTON
29701028.C
COMPLETE
AC/DC XG TIMER (4) DOUBLE LENGHT
SPIRAL CABLE
32000359
1
KIT DOUBLE LENGHT SPIRAL CABLE +
EXPOSURE BUTTON
29701029.C
COMPLETE
5
AC/DC XG TIMER (5) EXPOSURE BUTTON
CASE
29700974.C
4
6
AC/DC XG TIMER (6) ESPOURE BUTTON
BOARD
39700303
1
7
AC/DC XG TIMER (7) LED BOARD
39200313
7
8
AC/DC XG TIMER (8) KEYBOARD DEG
39200510
8
AC/DC XG TIMER (8) KEYBOARD SAT
39200309
9
AC/DC XG TIMER (9) BOTTOM TIMER CASE
29700975.C
29700975
1
10
AC/DC XG TIMER (10) TOP TIMER CASE
DEG
29700304.C
29700304
4
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
4
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OLD COLOR
Q.TY PCS
32000325
1
39200308
1
1
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REF
SPARE PARTS PANTOGRAPH TYPE ARM
Xmind®
CODE
(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
4
PANTOGRAPH ARM ANTERIOR TIE-BEAM
(2 pz)
29700460
4
5
PANTOGRAPH ARM ANTERIOR TIE-BEAM
HOLDER
29700458
6
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
10
PANTOGRAPH ARM ALLEN WRENCH
LOADING KEY
22000543
11
AC/DC XG B (11) INTERNAL COVER
27500758.C
27500758
1
12
AC/DC B (12) ESTERNAL COVER
27500757.C
27500757
1
13
PANTOGRAPH ARM POSTERIOR TIE-BEAM
(2 pz)
29700992
7
14
AC/DC XG B & HALF-MOON LOCKER
22000176
1
15
AC/DC B (15) COVERS BRACKET SIDE
29700994.C
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OLD COLOR
Q.TY PCS
29700990
9
1
29700994
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REF
SPARE PARTS WALL PLATE 350
CODE
(RAL 9010 color)
OLD COLOR
Q.TY PCS
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
4
PIASTRA (4) PLASTIC JOINT + PLASTIC
CAPS
29701036.C
29701036
3
WALL PLATE 350 DEG
29700383.C
29700383
COMPLETE
WALL PLATE 350 SAT
29700384.C
29700384
COMPLETE
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REF
SPARE PARTS WALL PLATE 350
CODE
(RAL 9010 color)
OLD COLOR
Q.TY PCS
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
4
PIASTRA (4) PLASTIC JOINT + PLASTIC
CAPS
29701036.C
5
PIASTRA (5) TOP MOUNT COLLAR
22000597
WALL PLATE 350 TOP DEG
WALL PLATE 350 TOP SAT
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29701036
3
29700988.C
29700988
COMPLETE
29700385.C
29700385
COMPLETE
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SPARE PARTS BRACKET
CODE
(RAL 9010 color)
OLD COLOR
Q.TY PCS
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
2
BRACKET SLIDE COVER AC/DC 14X1.4cm
RAL 9010
27502305
3
3
BRACKET ROTATION STOPPER
29701008
5
REF
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SPARE PARTS BRACKET
CODE
(RAL 9010 color)
OLD COLOR
Q.TY PCS
CIELING BRACKET
29700382.C
29700382
COMPLETE
SPARE PARTS BRACKET
CODE
(RAL 9010 color)
OLD COLOR
Q.TY PCS
DENTAL CHAIR BRACKET
29700381.C
29700381
COMPLETE
SPARE PARTS BRACKET
CODE
(RAL 9010 color)
OLD COLOR
Q.TY PCS
TOP MOUNT BRACKET 400
29700620.C
29700620
COMPLETE
TOP MOUNT BRACKET 800
29700621.C
29700621
COMPLETE
TOP MOUNT BRACKET 1100
29700622.C
29700622
COMPLETE
REF
REF
REF
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A1
ANNEXES
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%
X-ray emission time accuracy
±5%
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)
Reference current-time product
0,4 mAs 4 mA
Intensity of radiation in the air
> 30 µGy/h at 1 m from focal spot
Leakage radiation (measured @ 70 kV, 8 mA, 3,2 s)
< 0,25 mGy/h at 1 m from focal spot
Operating cycle
1:32
0,400 s ≤ t ≤ 3,2 s
0,1 s
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-073B-DC
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
230 V
115 V
Maximum voltage variation
±10%
Nominal current
5,2A @ 230V
9,5A @ 115V
Supply voltage frequency
50/60 Hz
Maximum line current (measured @ 70 kV, 8 mA, 3,2 s)
9,5 A @ 115 V
Absorbed power
1,2 kVA @ 230V
1,1 kVA @ 115V
Apparent resistance
0,5 Ω
0,2 Ω
Protection fuses (F1 – F2 – F3 – F4)
F 8 A – 250 V
F 12,5 A – 250 V
Circuit protection fuses
(F5) – n° 1 630 mA – 125 V
(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
Use with flammable anaesthetics
Not for use in presence of flammable
anaesthetic mixture with air, oxygen or
nitrous oxide.
Sterilization and disinfection methods
The device is supplied not sterile and it must
not be subjected to sterilization
Operation mode
Continuous operation with intermittent X-ray
loading
MECHANICAL DATA
Total weight
19,5 kg (wall mounting)
50 kg (mobile version)
Weight of the tubehead
5,5 kg
Mechanical configuration
Wall mounting, top and bottom / Mobile
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A2
ANNEX 2
A2. INTENDED ENVIRONMENT
CAUTION
“Xmind®dc” is for INDOOR USE ONLY.
If the “Xmind®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
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A3
ANNEX 3
A3. LIST OF INTERNATIONAL STANDARDS AND DIRECTIVES
“Xmind®dc”: X-ray equipment for dental intraoral radiography, is in compliance with the following:
• 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
• 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)
60
1,9
2,4
70
2,2
2,5
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
mA
60
4
70
8
Time (s)
4
8
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
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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
mA
4
70
8
Time (s)
4
8
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
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BLD Shape
Circular
SSD (mm)
310
kV
mA
60
4
70
8
Time (s)
4
8
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
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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
“Xmind®dc” is intended to be used in the electromagnetic environment specified below. The customer or the
operator of “Xmind®dc” must ensure that the device is used in this type of environment.
Emission test
Conformity
RF emissions
CISPR 11
Group 1
RF emissions
CISPR 11
Class B
Harmonic emissions
CEI EN 61000-3-2
Class A
Voltage fluctuations/flicker
emissions
CEI EN 61000-3-3
Complies
Electromagnetic environment guidance
“Xmind®dc” uses RF energy only for internal operation.
RF emissions are extremely and attenuated are not likely
to generate interference with electronic equipment in the
vicinity.
“Xmind®dc” is suitable for use in all establishments, including
domestic establishments and those directly connected to
the public low-voltage power supply network that supplies
buildings used for domestic purposes.
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Guidance and manufacturer’s declaration – electromagnetic immunity
“Xmind®dc” is intended to be used in the electromagnetic environment specified below. The customer or
“Xmind®dc” operator must ensure that the device is used in this type of environment.
Immunity test
CEI EN 60601 test level
Compliance level
Electromagnetic environment
guidance
Electrostatic
discharge (ESD)
CEI EN 61000-4-2
+/- 6 kV contact
+/- 8 kV air
CEI EN 60601-1-2
Test level
Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity must be at least 30%
Electrical fast
transient/burst
CEI EN 61000-4-4
+/- 2 kV for power supply lines CEI EN 60601-1-2
+/- 1 kV for input/output lines Test level
Mains power quality should conform
to that of typical commercial or
hospital applications.
Surge
CEI EN 61000-4-5
+/- 1 kV differential mode
+/- 2 kV common mode
CEI EN 60601-1-2
Test level
Mains power quality should conform
to that of typical commercial or
hospital applications.
CEI EN 60601-1-2
Test level
Mains power quality should
conform to that of typical
commercial or hospital applications.
If the “Xmind®dc” operator
requires continued operation even
during mains power outage, we
recommend powering the system
using a UPS.
CEI EN 60601-1-2
Test level
Power frequency magnetic fields
must be at the typical level of
standard mains for commercial or
hospital use.
<5 % UT for 0.5 cycles
(>95 % dip in UT)
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
CEI EN 61000-4-11
40 % UT for 5 cycles
(60 % dip in UT)
70 % UT for 25 cycles
(30 % dip in UT)
<5 % UT for 5 onds
(>95 % dip in UT)
Mains frequency
(50/60 Hz)
magnetic field
CEI EN 61000-4-8
3 A/m
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
“Xmind®dc” is intended to be used in the electromagnetic environment specified below. The customer or
“Xmind®dc” operator must ensure that the device is used in this type of environment.
Immunity test
CEI EN 60601
test level
Compliance
level
Electromagnetic environment guidance
Portable and mobile RF communication
equipment must be used no any closer to any part
of the “Xmind®dc”, including cables than the
recommended separation distance, calculated
according to the equation corresponding to the
frequency of the transmitter.
Conducted RF
CEI EN 61000-4-6
3 Vrms
150 kHz to 80 MHz
3 Vrms
Recommended separation distance
d = 1,2 √P
d = 1,2 √P 80 MHz - 800 MHz
d = 2,3 √P 800 MHz - 2.5 GHz
Radiated RF
CEI EN 61000-4-3
10 V/m
80MHz to 2.5GHz
3 V/m
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
as determined by an electromagnetic site
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 “Xmind®dc”.
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
“Xmind®dc” medical device
These devices are intended to be used in environments where radiated RF interference is controlled. The
customer or “Xmind®dc” operator can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communication equipment (transmitters) and “Xmind®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
150 kHz - 80 MHz
80 MHz - 800 MHz
800 MHz - 2.5 GHz
[W]
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
“Xmind®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.
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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.
3
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 •ww.acteongroup.com