User Group Requirements - Dräger Perseus A500 Instructions For Use Manual

User group requirements

The term "user group" describes the personnel
responsible who have been assigned by the
operating organization to perform a particular task
on a product.
Duties of the operating organization
The operating organization must ensure the
following:
– Every user group has the required
qualifications (e.g., has undergone specialist
training or acquired specialist knowledge
through experience).
– Every user group has been trained to perform
the task.
– Every user group has read and understood the
relevant chapters in this document.
User groups
Clinical users
This user group operates the product in
accordance with the intended use.
Users have medical specialist knowledge in the
field of anesthesia. Users have knowledge of
device monitoring and perioperative care.
Reprocessing personnel
This user group carries out the necessary activities
to reprocess the product.
Reprocessing personnel has specialist knowledge
in the reprocessing of medical devices.
Service personnel
This user group installs the product and performs
the service activities.
Service personnel has specialist knowledge in
electrical and mechanical engineering and
experience in the servicing of medical devices.
Instructions for use Perseus A500 SW 2.0n
Information about this document
Where product specific knowledge or tools are
required, the service activities must be carried out
by specialized service personnel. The specialized
service personnel was trained by Dräger for these
service activities on this product.
7