3.4 DEFINITION: “RESPONSIBLE BODY” OF THE DEVICE
Responsible Body: “individual or group responsible for the use and maintenance of equipment”.
Definition taken from the standard IEC61010-1:2010, par. 3.5.12.
The responsible body should be clearly identified inside the structure where the appliance is operated (i.e.
name and responsibility registered on company forms).
3.5 TYPE OPERATOR AND “SUPERUSER”
The machine can be only used by staff members who have been specifically trained.
INTENDED USER PROFILE: the characteristics of the “TYPE OPERATOR:
- staff specifically trained for the use of the appliance.
- staff trained in the thermal disinfection process and in the cycle of treatment of medical devices.
It involves staff working in hospitals and dental centers, generally paramedics and nurses.
The installer technician is responsible for training staff when installing the appliance.
The manufacturer declines all liability in case of any malfunction or accident caused by use of the appliance
by untrained staff.
Staff preparation includes specifications on possible risks in using the appliance as well as training to
perform operating procedures in the safest way possible.
The installer technician must also communicate USER and SUPERUSER passwords to the responsible body in
order to access the configuration parameters. The responsible body is responsible for preserving the
passwords in a safe place.
It’s the RESPONSIBLE BODY’s task to make sure that whoever operates the appliance has been adequately
trained on its functioning, safe use and routine controls, and to ensure the continued training of all operators.
Staff training should be checked regularly.
The installer technician is responsible for the correct functioning of the appliance after the installation.
Safety information provided in compliance with 5.4.101.1 IEC61010-2-040:2015.
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