X MIND DC Operators Manual Rev D Nov 2016

ENGLISH MANUFACTURER de Götzen® S.r.l. - a company of ACTEON Group Via Roma, 45 21057 OLGIATE OLONA (VA) – ITALY Tel. +39 0331 376760 Fax +39 0331 376763 www.acteongroup.com For information and technical assistance, contact the manufacturer [email protected]

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ENGLISH THE RADIOGRAPHIC SYSTEM DESCRIBED IN THIS MANUAL REFERS BOTH TO A WALL INSTALLATION AND TO THE MOBILE VERSION. de Götzen® S.r.l. – ACTEON Group RESERVES ITSELF THE RIGHT TO MODIFY THE PRODUCTION AND THE MANUAL WITHOUT NOTICE. IT IS PROHIBITED TO MODIFY, COPY, REPRODUCE, DISPLAY, SHARE, DISCLOSE AND PUBLISH THIS MANUAL AND ALL OTHER DOCUMENTS REFERRING TO “x-mind dc” IN ANY FORM WITHOUT PRIOR WRITTEN CONSENT BY de GÖTZEN® S.r.l. – ACTEON Group. THE MANUAL MUST ALWAYS BE KEPT NEAR THE MEDICAL DEVICE FOR FUTURE REFERENCE. de Götzen® S.r.l. – ACTEON Group SHALL NOT BE LIABLE FOR AN INCORRECT USE OF THE INFORMATION CONTAINED IN THIS MANUAL.

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

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ENGLISH CONTROL PANEL

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

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ENGLISH CHAPTER 1 1.1. PRELIMINARY INFORMATION Before beginning to use the “x-mind dc” radiographic system, it is mandatory to carefully read and follow the instructions contained herein, so as to obtain the best possible performance and to assure the safety of the patient, operator, device and environment.

LEGEND

Always pay close attention to the CAUTION WARNING PLEASE NOTE messages when operating the system.

CAUTION The word CAUTION identifies those occurrences which might compromise the operator’s personal safety or cause injuries to people. ! WARNING

The word WARNING identifies those occurrences which might compromise the radiographic system’s performance. PLEASE NOTE PLEASE NOTE serve to give special indications so as to facilitate maintenance or make important information clearer.

1.2. INFORMATION FOR THE OPERATOR Dear Customer, thanks for having chosen the “x-mind dc” radiographic system. It is designed and manufactured by de Götzen® S.r.l. – ACTEON Group and is the result of many years of experience in the field of radiology and in the application of advanced electronics. This high performing system represents a further development of technological research at the service of dental radiography. The “x-mind dc” is an X-ray generator for dental intra-oral X-ray imaging, particularly, “x-mind dc” is an extraoral source of X-rays, intended to be used for producing diagnostic dental radiographs for treatment of disease of teeth, jaw and oral structures. From a clinical point of view, “x-mind dc” can be applied in routine dental radiography examinations involving the diagnosis, treatment, i.e. surgical or interventional, of disease of the teeth, jaw and oral cavity structures. Its intended medical applications are: • Generic dentistry • Dental implantology • Dental surgery The intended population can be whatever, anyway the sustainability of the X-ray exposure must be evaluated by surgeons, dentists and qualified and authorized physicians. The Intended user profile is an able-bodied specialized surgeon, dentist and authorized personnel, who meet Page 6 of 61

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ENGLISH the requirements provided by the national laws in force in the country of installation; they must understand the language of the country where the device is installed. The intended conditions of use are detailed in Annex A2 (“Intended Environment”). PLEASE NOTE This manual does not contain all the recommendations and the obligations relative to the possession of a source of ionising radiations – since they do vary from Country to Country – but only the most common ones. The user must consult his country’s legislation so as to fulfil all local obligations. ! WARNING

This manual describes how to set and use the “x-mind dc” X-ray system. The operator must read and understand the manual before using the medical device. This manual must be always kept as a reference document. Before using this device for the first time, it is essential to thoroughly and carefully read the instructions, CAUTION and WARNING messages listed in the present chapter. It is mandatory to comply with these instructions every time the device is used. “x-mind dc” is compatible with all kind of X-ray detectors which have been designed and certified for dental intra-oral radiology; in detail, such a compatibility is ensured by the compliance of the “x-mind dc” device with the basic safety and essential performance requirements of the IEC 60601-2-65: 2012. 1.3. QUALITY DETERMINANTS IN X-RAY INTRAORAL RADIOGRAPHY Image quality is linked to the precise and accurate acquisition of information from the X-ray beam transmitted through the patient (i.e., the X-ray detector). Most problems in dental radiography are not the result of X-ray equipment failure: the production of consistent and high quality X-ray diagnostic images, concurrent with minimal patient exposure, depends generally on different components: quality performance of equipment, characteristics of the modules used which affect the imaging system resolution (i.e.: X-ray image detector type and relevant image processing chain, analogue or digital) and optimal performance of the operator. Among the physical factors for achieving optimum image quality, the following can be considered: - optimum optical density and Wiener spectrum, - detectors for radiography must meet the needs of the specific radiological procedure where they will be used and key parameters are spatial resolution, uniformity of response, contrast sensitivity, dynamic range, acquisition speed and frame rate - minimization of motion blurring (using short exposure times), - minimization of geometric blurring (reducing the focal spot size and/or of the object-film distance), - geometric distortions, - correct positioning: errors in patient positioning when using uncoupled positioning devices during the various typologies of X-ray examinations may lead to exposure errors, which require additional X-ray exposures, thereby increasing the radiation dose adsorbed by the patient. This means that it is absolutely essential and mandatory that the operator consider the performances not only of the “x-mind dc” equipment itself, but the whole chain of components that bring to the final X-ray diagnostic image. The essential parameters and relevant metrics which describe the performance of dental X-ray system, with regard to imaging properties and patient dose, methods of testing and whether measured quantities related to those parameters comply with the specified tolerances, are stated by the respective manufacturers and by the requirements specified by the respective applicable standards. Radiographic films, film processing, digital X-ray image detectors, and imaging plates are vital parts in the imaging chain. It is responsibility of the operator to ensure that these components perform in an acceptable way, with respect to sensitivity, contrast and absence of artifacts. A test of the performance of these components shall precede any acceptance test measurement involving the irradiation of the X-ray detectors using the “x-mind dc”. OPERATOR’S MANUAL • X-Mind DC • VD • (06) • 11/2016 • NXDCEN010D

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ENGLISH ! WARNING

It is full responsibility of the operator and RESPONSIBLE ORGANIZATIONS of the “x-mind dc” to check that any kind of X-ray detectors used with the “x-mind dc” are in compliance with the requirements stated by their specific regulations in force and to the specifications stated by their respective manufacturers. 1.4. WARRANTY CODITIONS Inappropriate use or any arbitrary tampering with the equipment exempt de Götzen® S.r.l. – ACTEON Group, as manufacturer of the “x-mind dc” radiographic system, from any service under warranty or from any other liability. The warranty is valid only if the following precautions are taken: - any repairs, modifications, adjustments, recalibrations must be performed only by de Götzen® S.r.l. – ACTEON Group - the installation must be made by professionally qualified technicians according to the regulations in force - the system must be installed and used in compliance with the instructions given in this Manual and for the purposes and applications for which it was designed - the power supply must be adequate to supply the required power indicated in the radiographic system’s nameplate data - in order to safeguard one’s warranty rights, please fill in the enclosed Warranty Document, immediately after the installation is completed, together with the technician - The system must be checked completely at least each 12 months by professionally qualified technicians according to the regulation in force. Use the manuals provided with the device “x-mind dc” for reference. - In case of repair, please use only spare parts from the manufacturer of the “x-mind dc”. Otherwise basic safety and essential performances of the device will not be guaranteed. de Götzen® S.r.l. – ACTEON Group is not responsible for any damage caused by any person or thing as a consequence of non-compliance of any of the guidelines contained in all the manuals provided with the “x-mind dc” device. CAUTION No compliance of any of the above mentioned rules and all the indications provided by the manufacturer in the documentation, or successively in written paper or electronic format, will result in losing the warranty of the product and the manufacturer will be discharged from any 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. 1.5. TRANSPORT CONDITIONS The “x-mind dc” radiographic system travels at the receiver’s own risk. All claims for damage or miscarriage regarding the shipment must be pointed out in the presence of the shipping agent. In case of miscarriages, or actual or suspected damage, the receiver shall indicate the proper reserves on the way-bill or on the consignment note. 1.6. SAFETY WARNINGS A few safety recommendations which should be followed when using the “x-mind dc” radiographic system are listed here below.

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ENGLISH CAUTION GENERAL REQUIREMENTS RESPONSIBLE ORGANIZATION is the authority that has the responsibility for the USE and MAINTENANCE of the “x-mind dc” radiographic system. Training and preparation of personnel is responsibility of THE RESPONSIBLE ORGANIZATION. “x-mind dc” radiographic system is an X-ray generator and must be used and handled only by specialised surgeons, dentists and authorized personnel, who meet the requirements provided by the national laws in force in the country of installation. It is mandatory for the RESPONSIBLE ORGANIZATION to provide a routine and special maintenance schedule for medical equipment; this schedule must be documented for every device and transmitted to the various operating levels (*). The preventive maintenance (that must be performed at least every 12 months), which includes functional, performance and safety tests of the device, must be carried out by qualified, authorized professional technicians. It is mandatory to ensure patients’ health and safety and proper “x-mind dc” radiographic system operation (IEC 60601-1 etc.). These operations must be carried out according to the methods and frequency indicated in this manual and in the installation and maintenance manual. Failure to comply with this requirement or with the messages concerning anomalies will release the manufacturer from any liability for direct and indirect injuries to persons and/or damage to property or the environment. Furthermore, the managers of the facility, customers or collaborators will be held liable for any damage and/or accidents and/or degeneration of patients’ or operators’ health or of the surrounding environment. The RESPONSIBLE ORGANIZATION must also provide for the safe and proper use of the equipment. (*) For Italy refer to Presidential Decree 14/01/1997, Legislative Decree No. 81/2008 (as subsequently amended and modified). Operators must know the environmental and operating specifications of the device, as well as the procedures to follow in the event of hazards or emergency stops. “x-mind dc” radiographic system has been designed to acquire radiography images for dental intraoral X-ray imaging. The “x-mind dc” medical device must not be used for X-ray imaging of other body parts. Carefully follow the instructions of this manual to install, operate and maintain the “x-mind dc” radiographic system. In the event that local laws and standards are more restrictive than the manufacturer’s indications, the former supersede the latter. The RESPONSIBLE ORGANIZATION must comply with the standards and regulations in force concerning the installation of the medical device in consideration of the place of installation. The operator is cautioned to monitor the patient and the parameters of the “x-mind dc” radiographic system throughout the entire duration of the X-ray examination. It is prohibited to modify any part of the “x-mind dc”medical device. de Götzen S.r.l. – ACTEON Group and its authorized technicians are not required to verify compliance of the installation site with local standards concerning electrical safety and X-ray protection and with any other directive concerning safety in force in the country of installation. The RESPONSIBLE ORGANIZATIONS of the facility must ensure compliance of the installation site with the local laws in force. Before each examination, it is mandatory to apply to the collimator cone (Beam Limiting Device) a disposable protection sheath designed to cover the end part of the X-ray unit, which is more susceptible of being directly contaminated during the X-ray exposure (class I Medical Device Directive 93/42/EEC and subsequent amendments). It can come into contact with the patient’s skin: verify biocompatibility according to the principles given in the ISO 10993 series of standards, refer for details to the disposable use protection’s instructions for use. Before operating the “x-mind dc” radiographic system you must assure that the device has no visible signs of damage.

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ENGLISH CAUTION PROTECTION AGAINST RADIATIONS “The general principles regarding safety and protection of workers and people” must always be applied when using the unit: 1. Justification of the practice 2. Protection Optimisation 3. Reduction of the limits of individual dose and risks The “x-mind dc” is a medical device that generates X-rays; therefore, both the patients and the operator are exposed to risks due to ionizing radiation. The physician must assess the actual need for X-ray exposure. All personnel present during an X-ray examination must comply with safety regulations concerning protection against radiation. For their own safety, the operator must always keep a distance of more than 2 meters (6 ft.) and out of the path of the X-ray beam, in order to avoid the exposition to the stray radiation. The “x-mind dc” medical device must be used in compliance with the local standards in force and with the international directives concerning radiation protection. The device must comply with the guidelines and indications provided by an accredited specialist in radiation protection, who will recommend, if necessary, additional shields or precautions for every specific case. The device installation site must be shielded in compliance with the local standards in force to protect the operator, patient and other people against X-rays. The “x-mind dc” device is intended to be used solely by surgeons, dentists and qualified and authorized physicians. The operator must: - determine, when appropriate, the possible need for sedation and the related operating methods and appropriate precautions for the patient - supervise the entire X-ray examination procedure, paying attention to the indications and information from the unit. The device must be used only for diagnostic purposes by qualified and authorized dentists and/or physicians. The operator and other personnel must keep clear from the patient during the scan. The personnel involved in the radiographic examination must take all the safety measures concerning radiation protection. It is the operator’s responsibility to protect the patient against unnecessary or excessive radiation doses. Additional protection devices (aprons, collars, etc) are required to protect the patient from radiation. Before exposing patients with pacemakers, contact the manufacturer of the latter to ensure that the X-rays generated by “x-mind dc” do not interfere with its functionality. “x-mind dc” generates X-rays: before using this X-ray system please refer to the regulation in force in your area concerning paediatric patients, pregnant women and anyone with health issues that contraindicate the use of X-rays. Investigate and make sure of this condition before starting the exposure.

This symbol indicates X-ray hazard.

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ENGLISH CAUTION MECHANICAL RISK Before removing the tubehead from the positioning arm, RELEASE THE SPRING. The sudden opening of the joint may cause damage to people and/or things. Check that the installation of the unit complies with the mechanical specifications of the support (walls, ceiling, etc..) where it is installed. Adjustments or any kind of attempt of repairing or disassembling must only be performed by qualified and authorized service personnel. The “x-mind dc” must not be used in environments or close to environments subjected to mechanical vibrations or mechanical shocks.

CAUTION ELECTRIC SAFETY The radiographic system contains high voltage. It is prohibited to inspect internal parts of the system. Never attempt to open the X-ray tubehead. The covers on the “x-mind dc” radiographic system must only be removed by qualified and authorized service personnel. The unit must be used only in environments that are in compliance with all electrical safety standards set forth for medical environments. To avoid the risk of electric shock, this device must only be connected to a supply mains with protective earth. The unit is NOT equipped with protections against penetration of liquids; it will therefore be necessary to make sure that no water or other liquids penetrate inside in order to avoid short circuits or corrosion. Always disconnect the radiographic system from the power supply and wait for 2 minutes before beginning cleaning and disinfecting operations. Do not connect the X-ray system to a multiple portable socket outlet (MPSO) nor to any type of extension cord. External equipment intended for connection to signal input, signal output or other connectors shall comply with the relevant product standard e.g. IEC 60950-1 for IT equipment and the IEC 60601-series for medical electrical equipment. In addition, all such combinations – systems – shall comply with the safety requirements stated in the standard IEC 60601-1, edition 3, clause 16. Any equipment not complying with the leakage current requirements in IEC 60601-1 shall be kept outside the patient environment i.e. at least 1.5 m from the patient support. It is mandatory to use an isolation device (Separation Device) to isolate the equipment located outside the patient environment from the 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 IEC 60601-1, edition 3, clause 16. For the wall version of “x-mind dc”: based on the IEC 60601-1, the installation is a permanent type (fixed). IT IS NOT ALLOWED TO connect the equipment to the main supply using a plug. The cone (beam limiting device) is an APPLIED PART of the system and it is classified as type B.

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ENGLISH CAUTION EMC COMPATIBILITY EMC requirements must be considered and the “x-mind dc” must be installed and used accordingly with the specific EMC information provided in the accompanying documents. The device complies with the EMC (Electromagnetic Compatibility) requirements, according to IEC 60601- 1-2. Radio transmitting equipment, cellular phones etc. shall not be used in close proximity of the unit as they could influence the performance of the system. Carefully read the indications relevant to the EMC in the dedicated appendix A5. EMC compatibility of this manual.

CAUTION PROTECTION AGAINST EXPLOSIONS The radiographic system MUST NOT be used in the presence of disinfectant, flammable or potentially explosive gases or vapours that might catch fire and cause damage. In case these disinfectants have to be used, let the vapour completely disperse before turning on the radiographic system.

CAUTION SYSTEM MODIFICATIONS OR UPGRADES Modifications or upgrades of the system can be carried out only if advised by de Götzen® S.r.l. – ACTEON Group and performed by authorized and qualified personnel, using ONLY genuine original spare parts of de Götzen® S.r.l. – ACTEON Group. de Götzen® S.r.l. – ACTEON Group proscribes improper, unauthorized modifications or upgrades of the device, in order to avoid malfunctions resulting in breakdowns and/or accident for patient, operator and equipment. de Götzen® S.r.l. – ACTEON Group assumes no responsibility and, consequently, declines all responsibility with respect to direct or indirect damages to people, the device or environment due to these reasons. Do not remove or attempt to remove the plastic covers of the device. It is strictly forbidden to attempt to repair electronic or mechanical parts by yourself. Disregarding this warning can result in irreversibly compromising the overall safety of the system and can be dangerous for operators, patients and environment.

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ENGLISH CHAPTER 2 2.1. RADIOGRAPHIC SYSTEM The “x-mind dc” radiographic system guarantees the maximum safety both for the operator and the patient. It is built in compliance with the following European Directives: ►93/42/EEC and subsequent amendments MEDICAL DEVICES ►EURATOM 96/29 IONISING RADIATIONS and in compliance with the following American Standard: ►American Radiation Performance Standard 21 CFR, Subchapter J, Sec. 1020.30 and 1020.31 The following protective measures were adopted in the design and construction of the unit: - protection against the risk of electric injuries, ensured by a grounded protection conductor; - protection against leakage radiation, made negligible by the shielded casing; - protection against excessive radiations, thanks to the immediate activation of the safety device; - protection against continuous service, since the system is designed, according to standards, not to allow use in radioscopy; - protection for the patient against dangerous radiations, obtained by means of the high frequency technology capable of producing a constant and hard radiation; - protection against exposure mistakes obtained with the high frequency technology which is unaffected by voltage fluctuation and consequently capable to guarantee extremely accurate exposure parameters; - protection for the operator against irradiation ensured by the extensible cable of the hand control which allows for a safety distance of more than 2 meters (6 ft.); - protection against involuntarily selection of radiographic technique (FILM or DIGIT) obtained, according to standards, by means of confirmation on the selection key. “ELECTRO-MEDICAL” CLASSIFICATION According to paragraph §6 of the general safety regulations CEI EN 60601-1: 2007 on safety of medical equipment, the system is classified as: Class I - Type B “MEDICAL DEVICES” CLASSIFICATION According to the classification rules indicated in attachment IX of the EEC Directive 93/42 on medical devices and subsequent amendments the system is classified as: Class IIb “E.M.C.” CLASSIFICATION According to paragraph §4 of the CEI EN 55011, the system is classified as: Group 1 – Class B

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ENGLISH 2.2. SYSTEM COMPONENTS

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

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ENGLISH During X-ray exposition, the collimator cone comes in contact with the skin of the patient. Before each exam, it is necessary to apply to the cone a disposable protective cover designed to cover the end part of the X-ray generator. Such protection has two functions: avoid crosscontamination (from patient to patient) and prevent the possibility of inflammations or other types of reactions of the skin caused by contact with the material that constitutes the cone. 2.2.1. OPTIONAL ACCESSORIES ►SECOND CONTROL BUTTON ►x-mind dc LIGHT (Rx signalling lamp for external use) ►x-mind dc ECB (remote control button) 2.3. IDENTIFICATION TAGS The identification tags on the tubehead, on the timer and on the cone indicate the model number, the serial number, the manufacturing date and the main technical characteristics. 2.3.1. TUBEHEAD Model 230 V

x-mind ® dc

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

70kVp 8mA Total filtration: 2,4mm Al / 70kV Nominal voltage: 230V ~ 50/60Hz Class I X-ray tube: TOSHIBA DG-073B-DC SN SN tube:

0477

0.7mm

Model 115 V

x-mind ® dc

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

70kVp 8mA Total filtration: 2,4mm Al / 70kV Nominal voltage: 115V ~ 50/60Hz Class I X-ray tube: TOSHIBA DG-073B-DC SN SN tube:

0477

0.7mm

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ENGLISH 2.3.2. TIMER Model 230 V

x-mind ® dc

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

Rated line voltage: 230V ~ 50/60Hz Absorbed power: 1,20kVA IP20

0477

Class I

SN

Model 115 V

x-mind ® dc

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

Rated line voltage: 115V ~ 50/60Hz Absorbed power: 1,10kVA IP20

0477

Class I

SN

CONE

GRADUATED SCALE

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ENGLISH PICTOGRAMS USED

SYMBOL INDICATING THE MANUFACTURER THIS SYMBOL GUARANTEES THAT THE RADIOGRAPHIC SYSTEM COMPLIES WITH THE REGULATIONS CONTAINED IN THE EUROPEAN DIRECTIVE EEC 93/42 REGARDING MEDICAL DEVICES SIZE OF THE FOCAL SPOT

THE DEGREE OF PROTECTION AGAINST DIRECT AND INDIRECT ELECTRIC CONTACTS IS B TYPE

SYMBOL INDICATING THE SERIAL NUMBER

SYMBOL INDICATING DANGER DUE TO IONISING RADIATIONS

X-ray EMISSION (IEC 60417)

PAUSE (IEC 60417)

ATTENTION, REFER TO THE ATTACHED DOCUMENTS

INSTRUCTIONS IN ELECTRONIC FORMAT

REFER TO MANUAL’S INSTRUCTIONS

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

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ENGLISH CHAPTER 3 3.1. CONFIGURATION The “x-mind dc” radiographic system is provided in the “standard mode” configuration. On the control panel the LED relevant to the following exposure parameters will light up:

No. of the selected tubehead LED 1 supplied cone LED 8” = SHORT CONE LED 12” = LONG CONE Type of tubehead LED DC = DIRECT CURRENT

radiographic voltage LED 70kV

radiographic current LED 8mA

type of patient LED ADULT

radiographic technique CONVENTIONAL LED D

The following exposure times (s) have been stored: 0,020 – 0,025 – 0,032 – 0,040 – 0,050 – 0,063 – 0,080 – 0,100 –0,125 – 0,160 – 0,200 – 0,250 – 0,320 – 0,400 – 0,500 – 0,630 – 0,800 – 1,00 – 1,250 – 1,600 – 2,000 – 2,500 – 3,200 PLEASE NOTE These times are in compliance with current CEI EN 60601-1: 2007 standard and with the ISO 497 series R’10 recommendations. THEY CANNOT BE MODIFIED

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ENGLISH Certain exposure values which depend on the selection of the operating parameters have been predefined: ►cone (8”/12”) ►type of patient (ADULT/CHILD) ►radiographic tecnique ►intra-oral test PLEASE NOTE These values have to be considered as “recommended”: it is possible to change these values if necessary. (refer to Charter 5 and 6) To modify these exposure values ►radiographic voltage (60kV/70kV) ►radiographic current (4mA/8mA) ►type of patient (ADULT/CHILD) ►radiographic tecnique (refer to Chapter 4) To modify these exposure values ►cone (8” /12”) ►type tubehead ►N° of control button change the dip-switch position, inside the timer THIS OPERATION MUST BE CARRIED OUT BY THE INSTALLER ONLY

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ENGLISH CHAPTER 4 4.1. INSTRUCTIONS FOR USE 1° - TURN ON

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

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

1. the green light turns on, indicating that the system is powered 2. the LEDs of the set parameters automatically light up 3. the exposure time is shown on the display CAUTION If an error is detected when the system is turned on, the anomaly is indicated as follows: - emission of an intermittent acoustic signal (beep) - MALFUNCTIONING INDICATOR LED intermittently turns on - the error code (E ….) appears on the display (refer to Chapter 8) - all control panel functions are inhibited In this case turn off the timer and then turn it back on. If the error persists, call the “Assistance Service”. PLEASE NOTE The exposure time and parameters which appear on the display are the last that were set before the timer was turned off. If the timer remains inactive for a few minutes, it switches to the stand-by mode. Press any key on the control panel to restore it to the operative mode.

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