Carilex DualFlex, Инструкция по эксплуатации, Страница: 6 / 28

1 Important notes for safe use
1.1 Designation of the groups of individuals
Named groups of persons
The named groups of persons in these Instructions for use are as follows
Operators
Users
•
•
Professionals
The authorised persons are skilled personnel, who are as a rule, the employees
of the operator and who:
•
have acquired their knowledge through professional training in the medical-
technical field,
•
carry out their activity on the basis of professional work experience and
instructions according to safety-related regulations and are able to detect possible
hazards during work.
In countries in which the pursuit of an activity in the medical-technical area is certified,
the classification as qualified personnel is subject to appropriate approvals.
Patients
Patients in the sense of these instructions are persons in need of care, who use the
air alternating pressure mattress replacement system DualFlex for therapy or care
purposes.
1.2 Notes for the users
Note that the hybrid alternating pressure mattress replacement system DualFlex
should only be used by persons who have been trained in the operation and
the intended use of the device.
1.2.1 Instruction
Training on the device The training of users on how to use the device must be carried out by the qualified
personnel of the operator using the device. If the device is approved for the patient,
then it is obligatory to comply with the instructions of this guidance.
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An operator (surgical suplier, health insurance, clinic, etc.) is any legal person,
which owns the Hybrid alternating pressure mattress replacement system DualFlex
and uses it, or on whose behalf the device is in use. The operator is responsible
for providing a safe device and to instruct the user properly on the operation and
safe use of the device.
Users are people who are entitled, due to their training or a corresponding instruction
to:
operate the hybrid alternating pressure mattress replacement system DualFlex
supervise patients using the device for therapy or care purposes
Users are fully responsible for the safe and correct use of the device. A review of the
functions has to be carried out and the proper condition of the device has to be
checked and confirmed by the user before each use or transfer for use.
Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex