Information regarding the instructions for use
Safety information definitions
WARNING
A WARNING statement provides important
information about a potentially hazardous
situation which, if not avoided, could result in
death or serious injury.
Target group
Duties of the operating organization
The tasks described in this document specify the
requirements that have to be met by each
respective target group.
The operating organization of this product must
ensure the following:
– The target group has the required qualifications
(e.g., has undergone specialist training or
acquired specialist knowledge through
experience).
– The target group has been trained to perform
the task.
– The target group has read and understood the
chapters required to perform the task.
Description of target groups
The target groups may only perform the following
tasks if they meet the corresponding requirements.
6
CAUTION
A CAUTION statement provides important
information about a potentially hazardous
situation which, if not avoided, may result in
minor or moderate injury to the user or patient or
in damage to the medical device or other
property.
NOTE
A NOTE provides additional information intended
to avoid inconvenience during operation.
Users
This target group includes healthcare
professionals such as surgeons and OR nurses.
Task
Use of the product in
accordance with its
intended use
Reprocessing personnel
This target group includes persons who are
responsible for the reprocessing of medical
devices.
Task
Reprocessing
Instructions for use Polaris 600
Requirement
Training in a relevant
healthcare field or in a
medical discipline and
knowledge of the use of the
product
Requirement
Specialist knowledge in the
reprocessing of medical
devices