MTR221/A - MTR221/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R221/A - R221/A DHHS
GENERAL
58
R221/A - R221/A DHHS - General
Ralco srl
• Atm. Pressure = from 500 a 1060 hPa.
SAFETY/RESPONSIBILITY
Ralco adheres to the directives governing manufacturers of electro-medical equipment:
Directive 2007/47/CE para.10 -Legislative Decree n° 46 para.10
Ralco shall not be held responsible when instructions provided in the present manual are not
complied with. Ralco shall not be held responsible if the collimator relates to one or several of
the following instances:
• The unit is of Ralco construction, built to client specifications with no CE marking.
• The unit has been modified by the OEM or end user.
• The unit has been installed without respecting the instructions provided in this manual.
• The unit is used without respecting the instructions provided in this manual.
• The unit has not been subject to routine functional inspection.
• The unit has not been subject to routine maintenance.
• The unit has been repaired with unoriginal spare parts.
• Ralco shall decline all responsibility for any damage, direct or indirect, caused to persons
or things by inappropriate accessories.
RESIDUAL RISKS
The collimator has been constructed to current standards to meet the safety requisites of
directive 2007/47/CE . However, due to the presence of x-rays, the type of application implies
a residual risk derived from possible faults that could occur during operation of the unit.
The Instructions contained in the this Manual will ensure the correct use of the device and
reduce the causes of possible hazards.
The residual risks of the device are reasonable; they have been assessed and approved in the
related Risk Management Plan contained the Technical Report.
INFORMATION REGARDING ACCIDENTS THAT HAVE OCCURRED WHILE USING THE RADIOLOGICAL
COLLIMATOR MUST BE REPORTED IMMEDIATELY TO RALCO SRL.
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