Acteon X-MIND prime - Operational Safety and Device Care; Patient and Operator Safety During X-ray Procedures

User Manual – Safety information
USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C
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3.1 Warnings
The device must be used in compliance with the procedures described and never be
used for purposes other than those indicated herein.
Before performing any maintenance operation, disconnect the unit from the power
supply.
X-MIND prime is an electric medical device and so can only be used under the
supervision of suitably qualified medical personnel, with necessary knowledge of X-ray
protection.
The user is responsible for compliance with legal requirements as regards ownership,
installation and use of the equipment.
The user is responsible for a safe set-up and maintenance of the host PC; as a general
guidance cybersecurity suggestions are given in paragraph 3.4 of this Manual.
The user is responsible for the execution of the routine quality control procedure
described in chapter 7 of this Manual.
This device has not been designed for use in environments where vapours, anaesthetic
mixtures flammable with air, or oxygen and nitrous oxide, may be present.
Do not let water, or other liquids, penetrate the device, as this could cause short circuits
and corrosion.
Before cleaning the device, make sure the main power supply has been disconnected
from the equipment. When pushing the ON/OFF button of the equipment, it must not
come on.
Wherever necessary, use appropriate accessories, such as leaded aprons, to protect the
patient from radiation.
While performing the X-ray, no-one, apart from the operator and the patient, must remain
in the room.
X-MIND prime has been built for continuous operation with an intermittent load; so the
described use cycles must be observed, to enable the device to cool down.
X-MIND prime must be switched off while using electrosurgical devices or similar
apparatus.
Warning
For safety reasons, the patient support arm must not be abnormally overloaded,
for example by leaning on it. The traction on the handle must be less than 16
kg.
Warning
To avoid the risk of electric shock, the equipment must only be connected to a
mains supply with earthing.
Clean and disinfect, when necessary, all parts that may come into contact with the
patient.
The centring bite or the bite protective sleeve must be replaced after each exam.
To avoid permanent damage to the unit, never try to rotate the moving arm manually
when the unit is switched on.
In the case of Error 362 or Error 760, movement is possible to let the patient exit.
Note
When the unit is switched on, do not move the rotating arm.