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Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H
ENGLISH
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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 bio-
compatibility according to the principles given in the ISO 10993 series of standards, refer for details to the disposable use protection’s
instructions for use.
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Before operating the X-MIND unity you must assure that the device has no visible signs of damage.
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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 environ-
ment.
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. Justification of the practice
2. Optimization of protection principle (ALARA principle)
3. Individual risk and dose limits
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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.
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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.
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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.
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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.
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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.
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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 appro-
priate for the patient
o supervise the entire x-ray examination procedure, paying attention to the indications and information from the unit.
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The device must be used for diagnostic purposes solely by qualified and authorized dentists and/or physicians.
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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.