2.1 DEFINITION OF THE GROUPS OF PERSONS INVOLVED
In this instruction manual, the following groups of persons are defined as:
Operator
The operator (e.g. nursing homes operators) are all natural and legal persons with
property rights to the Libra care bed. The operator is responsible for the safe
operation of this medical device.
Users
Users (nursing staff, carers, attendants etc.) are persons who, based on their
training, experience or briefing, are qualified to operate the bed on their own authority
or to carry out work on it, or have been instructed on how to handle this bed.
Furthermore, they are able to recognise and avoid potential hazards and assess the
clinical condition of the resident.
Residents
In this instruction manual, a resident is defined as a person who is infirm or in need of
care and occupies this bed.
It is a requirement that the operator or user instructs each new resident in the bed
functions that are important for him/her.