X MIND unity Operators Manual Rev G April 2015

ENGLISH Language of the original document: ENGLISH Important: All new editions and revisions of the manuals supersede the previous ones

Refer to complete manuals and instructions

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Operator’s manual • X-Mind unity • W1100021 • V1 • (15) • 04/2015 • NUN0EN010G

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 Website: www.degotzen.com - www.acteongroup.com E-mail: [email protected] (for generic requests)

For technical support: Tech. Support Webpage: http://support.degotzen.net https://support.degotzen.net

ITALY For information and technical assistance, contact the manufacturer Direct Tel.: +39 0331 376762 [email protected] WORLDWIDE Contact your authorised local dealer. Refer to the list in the following page to find the authorised dealer near you.

Operator’s manual • X-Mind unity • W1100021 • V1 • (15) • 04/2015 • NUN0EN010G

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ENGLISH FRANCE

ACTEON FRANCE / BENELUX / SUISSE ZAC Athélia IV - Avenue des Génévriers 13705 La Ciotat cedex - France Tel. +33 (0) 442 98 01 01 - Fax +33 (0) 442 71 76 90 E-mail: [email protected]

GERMANY

ACTEON GERMANY GmbH Industriestrasse 9 D-40822 Mettmann, GERMANY Tel: +49 (0)2104/9565-10 Fax: +49 (0)2104/9565-11 E-mail: [email protected]

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: [email protected]

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: [email protected]

USA

ACTEON Inc. 124 Gaither Drive, Suite 140 Mount Laurel, NJ 08054, USA Tel:+1 8562229988 Fax:++ 1 8562224726 E-mail: [email protected]

SOUTH AMERICA

ACTEON LATIN AMERICA Bogotà - COLOMBIA Celular: +57 312 377 8209 E-mail : [email protected]

RUSSIA

ACTEON RUSSIA Valdajski Proezd 16 – office 253 125445 Moscow - RUSSIA Tel./Fax. +7 499 76 71 316 E-mail : [email protected]

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 : [email protected]

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 : [email protected]

TAIWAN

ACTEON TAIWAN 14F.-1, No.433, Jingping Rd. Jhonghe Dist., New Taipei City 23563 TAIWAN (R.O.C.) Tel: +886 926 704 505 E-mail: [email protected]

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: [email protected]

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 : [email protected]

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 : [email protected]

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Operator’s manual • X-Mind unity • W1100021 • V1 • (15) • 04/2015 • NUN0EN010G

ENGLISH THE ELECTROMEDICAL EQUIPMENT DESCRIBED IN THIS MANUAL REFERS TO THE X-MIND unity MEDICAL DEVICE. “de Götzen® S.r.l. - ACTEON Group” RESERVES THE RIGHT TO MODIFY THE PRODUCT AND ALL THE MANUALS WITHOUT PRIOR NOTICE. IT IS PROHIBITED TO MODIFY, COPY, REPRODUCE, DISPLAY, SHARE, DISCLOSE AND PUBLISH THIS MANUAL AND ALL OTHER DOCUMENTS REFERRING TO X-MIND unity IN ANY FORM WITHOUT PRIOR WRITTEN CONSENT BY de GÖTZEN® S.R.L. - ACTEON Group THIS MANUAL MUST ALWAYS BE KEPT NEAR THE MEDICAL DEVICE FOR FUTURE REFERENCE. “de Götzen® S.r.l. - ACTEON Group” SHALL NOT BE HELD LIABLE FOR MISUSE OF THE INFORMATION PROVIDED BY THIS MANUAL.

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ENGLISH TABLE OF CONTENTS INTRODUCTION... 8 1.1. PRELIMINARY INFORMATIONS... 8 1.2. INFORMATION FOR THE OPERATOR... 9 1.2.1. Quality determinants in x-ray intraoral radiography... 10 1.3. WARRANTY CONDITIONS... 11 1.4. TRANSPORT CONDITIONS... 11 1.5. SAFETY WARNINGS... 12 X-RAY SYSTEM OVERVIEW... 18 2.1. SYSTEM COMPONENTS... 19 2.2. IDENTIFICATION TAGS... 21 CONTROL PANEL OVERVIEW... 25 3.1.STATUS LED... 26 3.2.INFORMATION DISPLAY... 26 3.3.SETTINGS... 27 3.4.TYPE OF PATIENT... 27 3.5.TYPE OF EXAMS... 27 OPERATING INSTRUCTIONS... 28 CONFIGURATION AND TAKING AN X-RAY EXPOSURE... 30 5.1.CHECK THE SELECTED TYPE OF CONE... 32 5.2.CHECK THE SOURCE TO SKIN DISTANCE... 32 5.3. CHECK THE SELECTED X-RAY TUBE VOLTAGE... 33 5.4.CHECK THE SELECTED X-RAY TUBE CURRENT... 33 5.5.CHECK THE SELECTED TYPE OF PATIENT... 33 5.6.CHECK THE SELECTED X-RAY DETECTOR SUPPORT (FILM/DIGITAL/PSP)... 34 5.7.CHECK THE SELECTED EXAM TYPE... 34 5.8.CHECK THE SELECTED IRRADIATION TIME... 35 5.9.CHECK THE DOSE AREA PRODUCT VALUES... 35 5.10. ENABLE ACE MODE (Optional Sopix/Sopix2 Inside Installed)... 36 5.11. POSITIONING THE PATIENT... 42 5.12. POSITIONING FILM or SENSOR... 42 5.13. POSITIONING THE X-RAY GENERATOR and COLLIMATOR (BEAM LIMITING DEVICE)... 44 5.14. MAKE THE EXPOSURE... 46 CHARTS OF DEFAULT EXPOSURE VALUES... 49 6.1.SHORT CONE: 8 INCHES – 20 CM SDD... 50 6.2.LONG CONE: 12 INCHES – 30 CM SDD... 51 CUSTOMIZE DEFAULT EXPOSURE VALUES... 53 7.1. RESTORING FACTORY VALUES... 54 X-RAY CALIBRATION PROCEDURE... 55 ERROR MESSAGES... 56 SUGGESTED MAINTENANCE AND REPAIR... 59 10.1. MAINTENANCE AND CLEANING... 59 10.2. DISPOSAL... 60 SSD - SOURCE TO SKIN DISTANCE and FOCAL SPOT POSITION... 61

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ENGLISH Annex A: Technical data... 62 A.1 Technical specifications... 62 A.2 Intended Environment... 66 A.3 Dimensions of the unit ... 66 A.4 List of International Standards and Directives... 71 A.5 Dosimetric Indications... 72 A.6 EMC compatibility... 76

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ENGLISH 1 INTRODUCTION 1.1. PRELIMINARY INFORMATIONS Before starting with the use of the “X-MIND unity” x-ray system, it is mandatory to carefully read and follow the instructions contained herein in order to obtain the best performance and assure the safety of the patient, operator, device and the environment. Always pay close attention to the messages when operating the system. CAUTION WARNING PLEASE NOTE 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 x-ray system’s performance. PLEASE NOTE PLEASE NOTE serves to give special indications to facilitate maintenance or make important information clearer.

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Operator’s manual • X-Mind unity • W1100021 • V1 • (15) • 04/2015 • NUN0EN010G

ENGLISH 1.2. INFORMATION FOR THE OPERATOR Dear customer, thank you for choosing the X-MIND unity x-ray system. This medical device has been designed and manufactured by de Götzen® S.r.l. - ACTEON Group and is the result of many years of experience in the radiology and medical imaging industry and of advanced electronic applications. This device is a further step forward in dental radiology. The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-MIND unity is an extra-oral source of X-rays, intended to be used for producing diagnostic dental radiographs for treatment of disease of the teeth, jaw and oral structures. From a clinical application point of view, the X-MIND unity can be applied in routine, dental radiography examinations involving the diagnosis, treatment, i.e. surgical or interventional, of diseases of the teeth, jaws and oral cavity structures. Its intended medical indication are: • generic dentistry; • dental implantology; • dental surgery. The intended population can be whatever, anyway the sustainability to X-ray exposure must be evaluated by surgeons, dentists and qualified and authorized physicians (refer also to section “SAFETY WARNINGS”) The Intended user profile is an able-bodied specialized surgeon, dentist and authorized personnel, who meet 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 A (“Intended Environment”) This manual has been written and published under the supervision of de Götzen® S.r.l. - ACTEON Group. It contains all the latest descriptions and features of the product. Although every effort is made to produce up-to-date and multi-language documentation (since each accompanying document is translated in different languages), this publication should not be regarded as an infallible guide to current specifications. The information in this manual is periodically updated; any amendment will be included in subsequent publications without prior notice by de Götzen® S.r.l. - ACTEON Group. Contact your dealer to request the latest version of the manual. In the event of errors, please inform de Götzen® S.r.l. - ACTEON Group promptly. CAUTION - ! WARNING This manual does not include all the recommendations and obligations concerning possession and use of ioniszng radiation sources, since they differ from country to country. Therefore, only the most common are listed Operators must refer to the laws in force in their country to meet all legal requirements. CAUTION - ! WARNING For the U.S. market: federal laws restrict these devices to sale by or on the order of a specialized surgeons, dentists and authorized personnel, who meet the requirements provided by the national laws in force in the country of installation. CAUTION - ! WARNING This manual describes how to set and use the X-MIND unity 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 paragraph General warnings and precautions. It is mandatory to comply with these instructions every time the device is used. X-MIND unity 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 unity with the basic safety and essential performance requirements of the IEC 60601-2-65:2012. The ACE feature is available only when X-MIND unity is used with Sopix/Sopix2 Inside sensor system. For details refer to section 5.10 ENABLE ACE MODE (Optional Sopix/Sopix2 Inside Installed). In case you’re using the X-MIND unity coupled with the Sopix/Sopix2 Inside x-ray digital sensor manufactured by SOPRO – Acteon Group, the operator is obliged to carefully follow the instructions of both equipments and their relevant accompanying documents, while observing all the safety measures to ensure the safe and correct functioning of both Operator’s manual • X-Mind unity • W1100021 • V1 • (15) • 04/2015 • NUN0EN010G

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ENGLISH 1.2.1. 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 (ito 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 unity 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 complying 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 unity1. ! WARNING

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

1

For example refer to IEC 61223-3-4 and similar standards.

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ENGLISH 1.3. WARRANTY CONDITIONS Inappropriate use or any arbitrary tampering with this equipment exempts, “de Götzen® S.r.l. - ACTEON Group”, as manufacturer of the “X-MIND unity” x-ray system, from any service under warranty or from any other liability This warranty is valid only if the following precautions are taken. Please refer to the following warranty conditions: • • • • • • • •

Any repair, modification, adjustment, or any kind of technical intervention must be performed only by de Götzen S.r.l. or by a qualified authorized representative 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 operator’s manual and in its associated documentation. The device shall be used in compliance with the purposes and applications for which it is designed. The power supply must be adequate to supply the required power indicated in the data contained in the labels of the device. In order to activate your warranty protection carefully read, fill and sign the Warranty Document provided by the seller, immediately after the installation is completed, together with the installer. The system must be checked completely at least each 12 months by professionally qualified technicians according to the regulations in force. Use the manuals provided with the device X-MIND unity for reference. In case of repair, please only use OEM spare partsfrom the manufacturer of the X-MIND unity Otherwise basic safety and essential performances of the device will be not guaranteed.

de Götzen S.r.l. is not responsible for any damages caused by any person or thing as a consequence of non compliance of any or all guidelines contained in all the manuals provided with the X-MIND unity 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 voiding 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. This will also result in service charges for non-warranty technical assistance.

1.4. TRANSPORT CONDITIONS The “X-MIND unity” x-ray system travels at the receiver’s own risk. All claims for damages or mishaps regarding the shipment must be pointed out in the presence of the shipping agent. In case of actual or suspected damages, the receiver shall indicate the proper reserves on the way-bill or on the consignment note.

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ENGLISH 1.5. SAFETY WARNINGS A few safety recommendations are listed here below which must be followed when using the “X-MIND unity x-ray system”. CAUTION GENERAL REQUIREMENTS •

RESPONSIBLE ORGANIZATION is the authority that has the responsibility for the USE and MAINTENANCE of the X-MIND unity system. The training and preparation of personnel is the responsability of THE RESPONSIBLE ORGANIZATION.

•

X-MIND unity 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 biomedical 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 twelve 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 unity operation (IEC 60601-1 etc.).These operations must be carried out according to the methods and frequency indicated in this manual, the installation and maintenance manual 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.

•

The X-MIND unity has been designed to acquire radiography images for dental intraoral x-ray imaging. The X-MIND unity medical device must not be used for x-ray imaging of other body parts.

•

Carefully follow the instructions in this manual to install, operate and maintain the X-MIND unity device. 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 unity throughout the entire duration of the x-ray examination.

•

It is prohibited to modify any part of the X-Mind unity 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.

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ENGLISH •

Before each examination, it is mandatory to apply a disposable protection sheath to the collimator cone (Beam Limiting Device) which is 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 unity you must assure that the device has no visible signs of damage.

•

The X-MIND unity has been certified by Accredited Laboratories, according to the requirements stated by the applicable standards, to operate alone or optionally in conjunction with (by means of specific internal connections and configurations) ONLY with the integrated use of the Sopix/Sopix2 Inside x-ray digital intraoral sensor. It is strictly forbidden to connect or forcing to connect to the X-MIND unity, under any circumstance, any other device than the Sopix/Sopix2 Inside sensor type manufactured by Sopro – Acteon Group Disregarding this warning can put the safety and performances of the X-MIND unity and Sopix/Sopix2 Inside to be irreversibly compromised with the consequence of damages or injuries to patients, operators and the environment. Failure to comply with this requirement or with the messages concerning the presence of eventual 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. CAUTION PROTECTION AGAINST RADIATIONS

The «General principles for safeguarding and protecting the personnel and patients» must always be applied during the use of the X-ray unit. 1. 2. 3.

Justification of the practice Optimization of protection principle (ALARA principle) Individual risk and dose limits

•

The X-MIND unity is a medical device that generates X-rays; therefore, both the patients and the operator are exposed to risks due to ionizingionizing 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.) from the x-ray beam.

•

The X-MIND unity medical device must be used in compliance with the local standards in force and with the international directives concerning radiation protection.

•

Compliance with the guidelines and indications provided by an accredited specialist in radiation protection, who will recommend, if necessary, the additional shields or precautions for every specific case.

•

The device installation site must be shielded in compliance with the local standards in force to protect the operator, patient and other people against X-rays.

•

The X-MIND unity device is intended to be used solely by surgeons, dentists and qualified and authorized physicians. The operator must: o determine, when appropriate, the possible need for sedation and the related operating methods and precautions best suited appropriate for the patient o supervise the entire x-ray examination procedure, paying attention to the indications and information from the unit. •

The device must be used for diagnostic purposes solely by qualified and authorized dentists and/or physicians.

•

The operator and other personnelmust keep clear from the patient during the scan. The personnel involved in the radiographic examination must take all the safety measures concerning radiation protection.

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ENGLISH •

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 unity do not interfere with its functionality

•

X-MIND unity 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 indicatesto X-ray hazards •

According to the paragraph 203.8.5.4 of the IEC 60601-2-65, in case you’re using the X-MIND unity device together with the integrated Sopix/Sopix2 Inside sensor, it is mandatory to install and use the original rectangular beam limiting device provided by the manufacturer of the X-MIND unity. CAUTION MECHANICAL RISK

•

Pay extreme attention to the tension of the internal spring of the scissor arm in order to avoid the arm opening outward and causing injury.

•

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 unity must not be used in environments or close to environments subjected to mechanical vibrations or mechanical shocks.

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ENGLISH CAUTION ELECTRICAL SAFETY •

The x-ray system contains high voltage. It’s prohibited to inspect internal parts of the system.

•

Never attempt to open the x-ray tube head.

•

The covers on the X-MIND unity equipment must only be removed by qualified and authorized service personnel.

•

The unit must be used only in environments that are in compliance with all the electrical safety standards set forth for medical environments.

•

The unit is NOTwaterproof; it will therefore be necessary to make sure that no water or other liquids penetrate inside the equipment so as to avoid short circuits or corrosion.

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Always disconnect the x-ray system from the power supply and wait for 2 minutes before commencing to clean or disinfect orperform any maintenance operations.

•

Do not connect the x-ray system to a multiple portable socket outlet (MPSO) or 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 collateral standard IEC 60601-1-1 or the general 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.

•

Any person who connects external equipment to signal input, signal output or other connectors has formed a system and is therefore responsible for the system to comply with the requirements. If in doubt, contact qualified medical technician or your local representative.

•

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

•

Based on the IEC 60601-1, the installation of the X-MIND unity wall version is a permanent type (fixed). IT IS NOT ALLOWED TO connect the equipment to the main supply using a plug.

•

Do not touch the USB connector of the x-ray sensor and the patient at the same time.

•

NEVER use the device without the presence of the lateral enclosure of the fork (example shown in the picture below) or without the proper fixing of the enclosure on the fork. In case if the Sopix/Sopix2 Inside is installed, the x-ray sensor support must also be present and properly fixed on the cover.

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ENGLISH

•

The cone (Beam Limiting Device) is an APPLIED PART of the system and is classified type B.

•

The Sopix/Sopix2 Inside Sensor (optional) is an APPLIED PART of the system and is classified type BF.

CAUTION EMC COMPATIBILITY •

EMC requirements must be considered, and the X-MIND unity must be installed and used accordingly with the specific EMC information provided in the accompanying documents.

•

The device complies with the EMC (Electromagnetic Compatibility) 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 EMC compatibility of this manual. CAUTION PROTECTION AGAINST EXPLOSIONS

The x-ray system MUST NOT be used in the presence of disinfectants, flammable or potentially explosive gases or vapors that might igniteand cause damage. IIf these disinfectants must be used let the vapors completely disperse before turning on the x-ray system.

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ENGLISH CAUTION SYSTEM MODIFICATIONS OR UPGRADES • • • • •

Modifications or upgrades of the system can be carried out only if advised by de Götzen® S.r.l. and performed by authorized and qualified personnel, using ONLY genuine original spare parts of de Götzen® S.r.l. de Götzen® S.r.l. proscribes improper, unauthorized modifications or upgrades of the device, in order to avoid malfunctioning resulting in breakdowns and/or accident for patient, operator and equipment. de Götzen® S.r.l. 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 attempt to repair electronic or mechanical parts by yourself. Disregardingthis 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 2 X-RAY SYSTEM OVERVIEW The “X-MIND unity” is manufactured in compliance with the following European Directives: ▪ 93/42/EEC and subsequent amendements MEDICAL DEVICES ▪ EURATOM 96/29 IONIZING RADIATIONS and in compliance with the following American Standard: ▪ American Radiation Performance Standard 21 CFR, Subchapter J Many protective measures have been adopted in the design and construction of the unit, such as: • • • • • •

protection against the risk of electric injuries, ensured by a grounded protection conductor and in accordance with the 2nd and 3ed of the IEC 60601-1, together with the applicable worldwide international deviations. protection against leakage radiation, made negligible by the shielded casing; protection against excessive radiations, thanks to the immediate activation of the safety device and the ACE option (if enabled); protection against continuous service, since the system is designed, according to standards, to not be used in radioscopy; protection for the operator against irradiation due to the extendable hand control and cable which allows for a safety distance of more than 2 meters (6 ft.) protection against accidental selection of the x-ray technique button selected (FILM or DIGIT) obtained, according to standards, by means of

“ELECTRO-MEDICAL” CLASSIFICATION According to the general safety regulations EC EN 60601-1 2nd and 3rd edition 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, this system is classified as: Class IIb “EMC” CLASSIFICATION According to paragraph §4 of the EN 55011, this system is classified as: Group 1 - Class B

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Operator’s manual • X-Mind unity • W1100021 • V1 • (15) • 04/2015 • NUN0EN010G

ENGLISH 2.1. SYSTEM COMPONENTS The X-MIND unity x-ray system (Fig.1) consists of the following components:

1. X-RAY CONTROL UNIT (TIMER) 2. With it’s clear and highly visible display this component allows for easy and clear selection, of the exposure settings, the creation of personal settings while alerting you with a visual display and an audible alert in case of incorrect operation or eventual failures. 3. This is possible due to the control panel which represents the operator interface between device and operator. 4. The timer also contains the x-ray exposure switch, which triggers the x-ray when the button is depressed. 5. The internal sub-mechanical architecture of the X-ray control unit provides the necessary wall framework for 6. fixating the control unit to a wall. 7. HORIZONTAL BRACKET The horizontal bracket is available in 3 different lengths and represents the support for the scissor arm. Its shaft is fixed in a dedicated section in the middle of the timer (top or bottom) and allows for 180° movement. 8. PANTOGRAPH TYPE ARM (SCISSOR) 9. Due to the new shape and mechanism of the articulating arm, it can be adjusted in height and depth for easy and precise movement to any position. It is equipped with internal balancing springs and made of extruded aluminum arms covered by PC-ABS material enclosures. 10. X-RAY SOURCE ASSEMBLY (TUBEHEAD) The tubehead of the X-MIND unity contains the x-ray tube, the high voltage board and the high frequency generator. The high voltage board, the x-ray tube and the expansion chamber are submerged in a sealed aluminum chamber containing highly dielectric insulating oil. The expansion chamber guarantees the expansion of oil over the whole range of operating temperatures according to the technical specifications of the device. Operator’s manual • X-Mind unity • W1100021 • V1 • (15) • 04/2015 • NUN0EN010G

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ENGLISH The emission of the x-rays is electronically controlled which guarantee a great accuracy of the loading factors. The tubehead is equipped with an angle scale indicator and is designed for easy handling and positioning of the tubehead during the x-ray examination. 11. SENSOR AND SENSOR HOLDER (OPTIONAL, SOLD SEPARATELY) 12. The X-MIND unity comes already prepared to be coupled as a separate installation performed by authorized technicians on the field), with the optional Sopix/Sopix2 Inside intraoral x-ray digital sensors (manufactured and sold by SOPRO - Acteon Group), which are equipped with the ACE technology. 13. COLLIMATOR CONE (Beam Limiting Device) Made of transparent polycarbonate or PC-ABS, it allows for: - correct focal spot to skin distance - dimension, direction and centering of the x-ray beam - implementation of different x-ray techniques (bisecting and parallel technique)

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Operator’s manual • X-Mind unity • W1100021 • V1 • (15) • 04/2015 • NUN0EN010G