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 manu-
factured 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 interven-
tional, 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 qualied and authorized physicians (refer also to section “SAFETY WARNINGS”)
The Intended user prole 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 specications. The informa-
tion 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 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 rst 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 certied 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
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