Xenios Compact Holder Mode D'emploi page 11

These Instructions for Use are provided for all staff required to work with
the compact holder and should be read through carefully prior to using
the compact holder The compact holder should only be used by special-
ly-trained and qualified staff
Even if the compact holder has been subject to a hazard analysis and the
design is in accordance with the current state of technology, residual risks
during clinical use remain These are addressed in the following Instruc-
tions for Use as limitations, contraindication, warnings and precautions
The compact holder is a class I medical device according to the Regulation
(EU) 2017/745 on medical devices (MDR)
Training of the compact holder will be provided combined with the corre-
sponding active medical device, by a Fresenius certified trainer or appoint-
ed trainer in the clinic The training consists of hands on system training,
e g in clinical setting and can include classroom based training
Note: xenios offers training courses in the precise handling and appli-
cation of the compact holder Further information and course
dates are available at www heart-and-lung-campus com
1. EXPLANATION OF SYMBOLS
DANgEr DANGER indicates a hazardous situation which, if not
avoided, will result in death or serious injury
WArNINg WARNING indicates a hazardous situation which, if not
avoided, could result in death or serious injury
CAuTION CAUTIoN indicates a hazardous situation which, if not
avoided, could result in minor or moderate injury
E x p L A N AT I o N o F S y M B o L S
EN
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