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2.5
DEFINITION: "RESPONSIBLE BODY" IN RELATION TO THE DEVICE
Responsible body: "Individual or group responsible for the use and maintenance of equipment".
Definition taken from the IEC 61010-1 standard.
The responsible body should be clearly identified within the facility where the device is used, (for example
by recording the relative name and responsibilities on corporate forms).
2.6
INTENDED USER AND SUPERUSER
The device may only be used by specifically trained staff.
INTENDED USER PROFILE: the characteristics of the "INTENDED USER" are as follows:
- staff specifically trained to use the device.
- staff trained concerning the thermal disinfection process and the medical device processing cycle.
The staff concerned are employed in hospitals or care homes and are generally paramedics or nursing staff.
The installation engineer is responsible for training the staff assigned to use the device at the time of
installation.
The manufacturer declines all liability in the event of malfunctions or accidents caused by use of the device
by untrained staff.
Staff training includes specific information on the possible risks involved in the use of the device, and training
in the safest possible way of carrying out the operating procedures.
The installation engineer is also responsible for notifying the responsible body of the USER and SUPERUSER
passwords for access to the setup parameters. The responsible body must keep these passwords in a safe
place.
It is the duty of the device's RESPONSIBLE BODY to ensure that those using the equipment have been suitably
trained in its operation, its safe use and routine checks, and that this training is suitably maintained.
Staff training should be checked regularly.
The installation engineer is responsible for ensuring that the device operates correctly after commissioning.
Safety information supplied in compliance with IEC61010-2-040.
User Manual
193909105 rev.02
BPW1260
Page 11 – 93
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