User Manual
RiX 70 DC
3
Do not drop, knock, or shake the unit: rough handling or use beyond the
recommendations may cause damage to internal circuitry.
The operator should take every reasonable precaution to maintain a safe and
healthy working environment, minimizing the radiation hazard.
During the exposure, make sure no one except the patient and operator are
present in the X-ray area.
In accordance with EN 60601-1, it is strictly forbidden to modify the equipment
or its parts.
Only trained and qualified technicians are authorized to remove the covers
giving access to the circuits.
The cables of the power supply must comply with applicable laws and must be
equipped with terminals for connecting to the protective earth.
Always turn off the machine and unplug it from the mains whenever possible
(with the switch) before cleaning and disinfection.
Carry out a proper cleaning and disinfection of all parts which come into
contact with the patient.
Check regularly (at least once a year) the state of correct operation of the
system by involving a specialist for any maintenance.
Do not use the device in the presence of vapours, or flammable anaesthetic
mixtures with air, or oxygen or nitrous oxide.
When using digital sensors, if the PC is positioned within the patient environment,
it must meet the requirements defined by the IEC 60601-1 medical device; if
located outside it must be in compliance with IEC 60950. The size of the patient
environment is defined as a minimum distance of 1.5 m from the patient.
1.3 About your unit
RiX-70 DC is an intraoral X-ray system that emits ionizing radiation, X Ray, for taking images of the
oral cavity. RiX-70 DC with a high technological development allows getting high quality images
using both normal films and digital images receptors (intraoral sensor and phosphor plates). This
system has two version, wall mounted and mobile.
1.4 Device Classification
RiX-70 DC is a Class I device, Type B, conforms to IEC 60601-2-65: 2012. RiX-70 DC, according to the
classification rules set out in Annex IX of EC Directive 93/42 and its amendments and supplements,
is an active medical device that releases energy (ionizing radiation X Ray) and represents a
potential hazard to the human body.