Instructions For Use Oxyline; Safety Information Definitions; User Group Requirements; Duties Of The Operating Organization - Dräger OxyLine Gebrauchsanweisung

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Safety information definitions

WARNING
A WARNING statement provides important in-
formation about a potentially hazardous situa-
tion which, if not avoided, could result in death
or serious injury.
CAUTION
A CAUTION statement provides important infor-
mation about a potentially hazardous situation
which, if not avoided, may result in minor or mod-
erate 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.

User group requirements

The term "user group" describes the personnel re-
sponsible who have been assigned by the operating
organization to perform a particular task on a prod-
uct.

Duties of the operating organization

The operating organization must ensure the follow-
ing:
– Every user group has the required qualifications
(e.g., has undergone specialist training or ac-
quired 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 ap-
plication of the product.
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 elec-
trical and mechanical engineering and experience in
the servicing of medical devices.
Where product specific knowledge or tools are re-
quired, the service activities must be carried out by
specialized service personnel. The specialized ser-
vice personnel was trained by Dräger for these ser-
vice activities on this product.

Instructions for use OxyLine