Operator's Manual
84 Pages
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X-RAY EQUIPMENT FOR DENTAL INTRA-ORAL RADIOGRAPHY
OPERATOR’S MANUAL THIS MANUAL MUST ALWAYS BE KEPT NEAR THE MEDICAL DEVICE
X-MIND unity - Operator’s manual -
DETAILS OF THE DOCUMENT
File name: X-MIND_unity_Operator's_Manual_ _unity_Operator's_Manual_1.3c.docx Type of document: X-MIIND unity x-ray ray system operator’s manual.
EDITION
REVISION
DATE
ISSUED BY
REVIEWED BY
APPROVED BY
1
3C
05-06-2013
PM, MM, CG
CG
M DG
LANGUAGE OF THE ORIGINAL DOCUMENT: ENGLISH
IMPORTANT: ALL NEW EDITIONS AND REVISIONS OF THE MANUALS MAN SUPERSEDE THE PREVIOUS ONES
Refer to complete manuals and instructions
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XM_unity_Operat _Operator’s_Manual Ed.1.3c-2013
- Operator’s manual - X-MIND unity
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.
XM_unity_Operator’s_Manual Ed.1.3c-2013
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X-MIND unity - Operator’s manual -
FRANCE
GERMANY
SPAIN
U.K.
USA
SOUTH AMERICA
RUSSIA
THAILAND
CHINA
TAIWAN
KOREA
INDIA
MIDDLE EAST
AUSTRALIA NEW ZEALAND
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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: [email protected] 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] 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] 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] ACTEON Inc. 124 Gaither Drive, Suite 140 Mount Laurel, NJ 08054, USA Tel:+1 8562229988 Fax:++ 1 8562224726 E-mail: [email protected] ACTEON LATIN AMERICA Bogotà - COLOMBIA Celular: +57 312 377 8209 e-mail : [email protected] ACTEON RUSSIA Valdajski Proezd 16 – office 253 125445 Moscow - RUSSIA Tel./Fax. +7 499 76 71 316 e-mail : [email protected] 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] 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] 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] 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: [email protected] 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] 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] 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]
XM_unity_Operator’s_Manual Ed.1.3c-2013
- Operator’s manual - X-MIND unity
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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TABLE OF CONTENTS TABLE OF CONTENTS _____________________________________________________________________________________6 1.
INTRODUCTION ______________________________________________________________________________________8 1.1.
PRELIMINARY INFORMATION ______________________________________________________________________8
1.2. INFORMATION FOR THE OPERATOR ___________________________________________________________________9 1.2.1. Quality determinants in x-ray intraoral radiography __________________________________________________11
2.
3.
1.3.
WARRANTY CONDITIONS ________________________________________________________________________12
1.4.
TRANSPORT CONDITIONS _______________________________________________________________________13
1.5.
SAFETY WARNINGS _____________________________________________________________________________13
X-RAY SYSTEM OVERVIEW ___________________________________________________________________________19 2.1.
SYSTEM COMPONENTS__________________________________________________________________________20
2.2.
IDENTIFICATION TAGS ___________________________________________________________________________22
CONTROL PANEL OVERVIEW _________________________________________________________________________26 3.1.
STATUS LED ___________________________________________________________________________________27
3.2.
INFORMATION DISPLAY __________________________________________________________________________27
3.3.
SETTINGS _____________________________________________________________________________________28
3.4.
TYPE OF PATIENT_______________________________________________________________________________28
3.5.
TYPE OF EXAMS ________________________________________________________________________________28
4.
OPERATING INSTRUCTIONS __________________________________________________________________________29
5.
CONFIGURATION and MAKING X-RAY EXPOSURE _______________________________________________________31 5.1.
CHECK THE SELECTED TYPE OF CONE ____________________________________________________________33
5.2.
CHECK THE SOURCE TO SKIN DISTANCE __________________________________________________________33
5.3.
CHECK THE SELECTED X-RAY TUBE VOLTAGE ______________________________________________________34
5.4.
CHECK THE SELECTED X-RAY TUBE CURRENT _____________________________________________________34
5.5.
CHECK THE SELECTED TYPE OF PATIENT __________________________________________________________35
5.6.
CHECK THE SELECTED X-RAY DETECTOR SUPPORT (FILM/DIGITAL/PSP) _______________________________35
5.7. CHECK THE SELECTED EXAM TYPE _______________________________________________________________36 5.7.1. Periapical Exam _____________________________________________________________________________36 5.7.2. Occlusal Exam ______________________________________________________________________________36 5.7.3. Bitewing Exam ______________________________________________________________________________36 5.8.
CHECK THE SELECTED IRRADIATION TIME _________________________________________________________37
5.9.
CHECK THE DOSE AREA PRODUCT VALUES ________________________________________________________37
5.10. ENABLE ACE MODE (Optional Sopix/Sopix2 Inside Installed) ___________________________________________38 5.10.1. Important notes about ACE technology and X-MIND unity ____________________________________________38 5.10.2. How to use the X-MIND unity with the ACE technology of Sopix/Sopix2 Inside _____________________________40 5.11.
POSITIONING THE PATIENT ____________________________________________________________________45
5.12.
POSITIONING FILM or SENSOR__________________________________________________________________45
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5.12.1. 5.12.2.
Paralleling Technique _________________________________________________________________________46 Bisecting Angle Technique _____________________________________________________________________47
5.13. POSITIONING THE X-RAY GENERATOR and COLLIMATOR (BEAM LIMITING DEVICE) ____________________48 5.13.1. Suggested Inclination Angles ___________________________________________________________________48 5.14. 6.
MAKE THE EXPOSURE ________________________________________________________________________49
CHARTS OF DEFAULT EXPOSURE VALUES _____________________________________________________________53 6.1.
SHORT CONE: 8 INCHES – 20 CM SDD _____________________________________________________________54
6.2.
LONG CONE: 12 INCHES – 30 CM SDD ______________________________________________________________56
7.
CUSTOMIZE DEFAULT EXPOSURE VALUES _____________________________________________________________58 7.1.
RESTORING FACTORY VALUES ___________________________________________________________________59
8.
X-RAY CALIBRATION PROCEDURE ____________________________________________________________________60
9.
ERROR MESSAGES__________________________________________________________________________________61
10.
SUGGESTED MAINTENANCE AND REPAIR ____________________________________________________________64
10.1.
MAINTENANCE AND CLEANING _________________________________________________________________64
10.2.
DISPOSAL ___________________________________________________________________________________65
Annex A: Technical data __________________________________________________________________________________67 A.1 Technical specifications _______________________________________________________________________________67 X-RAY SOURCE ASSEMBLY ___________________________________________________________________________67 Heating and cooling curve of the X-Mind unity X-Ray source Assembly (X-Ray Tube Housing) ________________________68 X-RAY TUBE ________________________________________________________________________________________68 FIRMWARE _________________________________________________________________________________________69 DEVICE POWER SUPPLY and ELECTRICAL CLASSIFICATION _______________________________________________70 ELECTRICAL CLASSIFICATION (IEC 60601-1)_____________________________________________________________70 DEGREE OF PROTECTION PROVIDED BY ENCLOSURES __________________________________________________71 MECHANICAL DATA __________________________________________________________________________________71 A.2 Intended Environment ________________________________________________________________________________72 CLINICAL ENVIRONMENT CONDITIONS (OPERATING CONDITIONS) _________________________________________72 TRANSPORTATION ENVIRONMENT CONDITIONS_________________________________________________________72 WAREHOUSING ENVIRONMENT CONDITIONS ___________________________________________________________72 A.3 Dimensions of the unit ________________________________________________________________________________73 FRONT VIEW (REST POSITION) - BOTTOM MOUNT _______________________________________________________73 FRONT VIEW (REST POSITION) - TOP MOUNT ___________________________________________________________73 SIDE VIEW (OPEN) - TOP MOUNT ______________________________________________________________________74 SIDE VIEW (CLOSED) - TOP MOUNT ____________________________________________________________________75 SIDE VIEW (OPEN) - BOTTOM MOUNT __________________________________________________________________76 SIDE VIEW (CLOSED) - BOTTOM MOUNT ________________________________________________________________76 A.4 List of International Standards and Directives ______________________________________________________________78 A.5 Dosimetric Indications ________________________________________________________________________________79 A.6 EMC compatibility ___________________________________________________________________________________81
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1. INTRODUCTION 1.1. PRELIMINARY INFORMATION 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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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 equipment 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 surgeons, dentists 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 ionising 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.
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X-MIND unity - Operator’s manual 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 the device for the first time, it is essential to carefully read completely 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. 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 follow carefully the instructions of both equipments and relevant accompanying documents, taking all the safety measures in order to warrant the safe and correct functioning of both equipments.
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1.2.1. Quality determinants in x-ray intraoral radiography Image quality is intimately linked to the precise and accurate acquisition of information from the x-ray beam transmitted by the patient (i.e. to the performance of 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 a dental X-ray equipment, 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, 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, for example 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 of the RESPONSIBLE ORGANIZATIONS of the X-MIND unity to check and maintain controlled that any kind of x-ray detector used with the X-MIND unity are complying 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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1.3. WARRANTY CONDITIONS Inappropriate use or any arbitrary tampering with, exempt “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.
The warranty is valid only if the following precautions are taken, please refer also to the 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 safeguard your warranty rights, read carefully, 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, only original spare parts of the manufacturer of the X-MIND unity must be used.
Otherwise basic safety and essential performances of the device will be not guaranteed.
de Götzen S.r.l. refuse all responsibility due to any damage coming from persons or things in consequence of nonobservance of all prescriptions contained in all the manuals provided with the X-MIND unity device.
CAUTION Disregarding the above mentioned rules and all the indications provided by the manufacturer in the documentation, or successively in written paper or electronic format, will cause the total losing of 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 also will have the result in service charges for non-warranty technical assistance.
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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.
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 it is included in the tasks of RESPONSIBLE ORGANIZATION.
•
X-MIND unity is an x-ray equipment and must be used and handled only by specialised surgeons, dentists and authorised 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, authorised 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, in 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 XMIND 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.
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•
The operator is obliged 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 parts of the X-Mind unity medical device.
•
de Götzen S.r.l. - ACTEON Group and its authorised 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 unity you must assure that the device has not visible damages.
•
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 (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 device which is different from the Sopix/Sopix2 Inside sensor type manufactured by Sopro – Acteon Group. If this warning will not be respected, the overall safety and performances of the X-MIND unity and Sopix/Sopix2 Inside can be irreversibly compromised with the consequence of damages or injuries to patients, to operators and to 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.
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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 Optimisation 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 ionising radiation. The physician must assess the actual need for X-ray exposure.
•
All personnel present during x-ray examination must comply with safety regulations concerning protection against radiation. For his 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.
•
Comply with the guidelines and indications provided by an accredited specialist in radiation protection, who will recommend, if necessary, the additional shields or precautions for every specific case.
•
The device installation site must be shielded in compliance with the local standards in force to protect the operator, patient and other people against X-rays.
•
The X-MIND unity device is intended to be used solely by surgeons, dentists and qualified and authorised physicians. The operator must: o determine, where appropriate, the possible need for sedation and the related operating methods and precautions appropriate to 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 authorised dentists and/or physicians.
•
The operator and other subjects 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 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 start the exposure.
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This symbol draws the ATTENTION to 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 extremely attention to the tension of the internal spring of the scissor arm in order to avoid the arm opening and causing injury.
•
Check that the installation of the unit respect 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.
CAUTION ELECTRICAL SAFETY •
The x-ray system contains high voltage. It’s not allowed to inspect internal parts of the system.
•
Never attempt to open the x-ray source.
•
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 NOT equipped with protections against penetration of liquids; it will therefore be necessary to make sure that no water or other liquids penetrate inside so as to avoid short circuits or corrosion.
•
Always disconnect the x-ray system from the power supply and wait for 2 minutes before beginning cleaning or disinfecting or maintenance operations.
•
Do not connect a multiple portable socket outlet (MPSO) or extension cord to the system.
•
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
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equipment not complying with the leakage current requirements in IEC 60601-1 60601 1 shall be kept outside the patient environment nt 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 co qualified medical technician or your local representative.
•
An isolation device (Separation Device) is mandatory needed to isolate the equipment located outside the patient environment from the equipment located inside the patient environment. In particular par such a Separation Device is required when a network or data connection is made. The requirements on the Separation Device is defined in IEC 60601-1-11 and in IEC 60601-1, 60601 edition 3, clause 16.
•
Basing on the IEC 60601-1, 1, the installation of the X-MIND unity wall version is permanent type (fixed). IT IS NOT ALLOWED TO connect the equipment to the main supply using a plug.
•
Don’t 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 the Sopix/Sopix2 Inside is installed, also the x-ray ray sensor support must be present and properly fixed on the cover.
• •
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. B
2013 XM_unity_Operator’s_Manual Ed.1.3c-2013
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X-MIND unity - Operator’s manual CAUTION EMC COMPATIBILITY • •
•
EMC requirements have to be considered, and the X-MIND unity must be installed and used accordingly with the specific EMC information provided in the accompany 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. Read carefully 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 catch fire and cause damage. In case these disinfectants have to be used let the vapors completely disperse before turning on the x-ray 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. 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.
•
If you don’t respect this warning you can compromise irreversibly the overall safety of the system and can be dangerous for operators, patients and environment.
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XM_unity_Operator’s_Manual Ed.1.3c-2013
- Operator’s manual - X-MIND unity
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, among which:
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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.
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protection against leakage radiation, made negligible by the shielded casing;
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protection against excessive radiations, thanks to the immediate activation of the safety device and the ACE option (if enabled);
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protection against continuous service, since the system is designed, according to standards, so as not to allow use in radioscopy;
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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.)
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protection against involuntarily selection of x-ray technique (FILM or DIGIT) obtained, according to standards, by means of the confirming of the key of selection.
“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, the system is classified as: Class IIb “EMC” CLASSIFICATION According to paragraph §4 of the EN 55011, the system is classified as: Group 1 – Class B
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X-MIND unity - Operator’s manual -
2.1. SYSTEM COMPONENTS The X-MIND unity x-ray system (Fig.1) consist of the following components:
1.
X-RAY CONTROL UNIT (TIMER) The timer represents the control unit of X-MIND unity device. This component allows easy and clear selection, with the help of clear and visible signals, of the exposure settings, perform personal settings and display alarms of the device in case of incorrect operation or eventual failures. This is possible thanks to the control panel which represents the operator interface between device and operator. The timer contains also the x-ray exposure switch, which is the hardware command allowing the x-ray exposure. The sub-mechanical architecture of the X-ray control unit represents the wall framework necessary for the wall fixation of the equipment.
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XM_unity_Operator’s_Manual Ed.1.3c-2013