User manual:
BiliCocoon™ Fixation System
IFU-BCC301-EnFr-2017-04-v03 Page 4
EN
NeoMedLight
88-90 rue Frédéric Faÿs 69100 VILLEURBANNE, FRANCE
April 2017
User liability
This user manual describes how the single-use BiliCocoon
™ Fixation System – referred to simply as the “fixation
system” (mounting system) – should be installed and used. The fixation system should be used with the BiliCocoon™
1
phototherapy system: the system comprises the fixation system and the phototherapy system, and is also referred
to as the “Device” in this document.
The fixation system should only be used appropriately by a trained user and should not be used if it is defective,
damaged or if there are any missing parts. In this case, NeoMedLight recommends you dispose of the device and
replace it.
The user will be considered solely responsible for the risks incurred by the patient, caregivers, third parties or goods;
or if the results differ from those expected due to improper or unsuitable use, or for any improper modifications made
to the fixation system.
Any serious incident which occurs in relation to the device should be reported to the manufacturer and the local
competent authority of the state in which the user and/or patient is established. You can contact NeoMedLight at the
following address:
.
According to U.S. Federal Law, the Product may only be sold to authorised professionals and upon their request.
NeoMedLight declares that this product complies with Directive 93/42/EEC.
Year the CE marking was added: 2016.
1
Also referred to as the BiliCocoon™ System in this document.
