INTRODUCTION
Thank you for choosing the X-MIND trium.
The electro medical equipment described in this manual refers to the X-Mind trium medical device.
X-MIND trium is a radiological device and must be used and handled only by specialised surgeons, dentists and authorised
and duly trained personnel, who meet the requirements provided by the national laws in force in the country of installation.
The training and preparation of personnel must be included in the tasks of the responsible organization.
Before using the X-MIND trium, the operator must read and understand all the instructions provided in the manual in order to
obtain the highest performance and ensure the safety of patients, of operators, of the medical device and the environment.
X-MIND trium is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, indicated for use in:
- producing panoramic X-ray images for diagnostic examination of dentition (teeth), jaws and oral structures;
- producing radiographs of maxillofacial region and parts of the skull for cephalometric examination, if equipped with CEPH
arm;
- producing radiographs of hands and wrists for carpus examination, if equipped with CEPH arm;
- producing tomographic images of the oral and maxillofacial region, for diagnostic examination of dentition (teeth), jaws,
oral structures and some cranial bones, if equipped with CBCT option.
From a clinical point of view, the X-MIND trium can be applied for the following medical applications:
• Generic dentistry
• Dental implantology
• Dental surgery
• Maxillo-facial surgery
• Cephalometric analysis
• Carpus radiology
The target patient population includes adults and pediatric patients from 5 years old [~21 kg (46 lb); 113 cm (44.5 in) standing
height]; anyway the sustainability to X-ray exposure must be evaluated by surgeons, dentists and qualied and authorized
physicians.
The intended user prole is a qualied, trained and authorized physician or dentist who meets the requirements provided
by national laws in force in the country of installation; the operator must understand the language of the country where the
device is installed.
Contraindications:
● Viewing cartilaginous structures;
● The CBCT technique has a limited capability of detecting soft tissues.
1.1 CAUTIONS
CAUTION :
CAUTION messages refer to circumstances that can jeopardise the operator’s safety, cause injuries to operators and patients or
damage the medical device and the environment.
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