Instructions for Use :
BiliCocoon™ Phototherapy System
IFU-BCC-SY-EnFr-2017-10-v13
1
EN
NeoMedLight
88-90 rue Frédéric Faÿs 69100 VILLEURBANNE, FRANCE
October 2017
User Responsibility
These Instructions for Use describe
the proper setup, use, and maintenance of the BiliCocoon™ phototherapy
system
a
- the Device or the System.
The Device is to be used exclusively by a properly trained user and should not be used if it is damaged,
contaminated, or if parts are missing. Instead, please contact the supplier immediately. For questions about
Device care and maintenance please contact the supplier or authorized staff member of your facility.
The user is solely responsible for the risks to the patient, clinicians, third parties or properties or for a treatment
with inadequate performances due to an abusive or improper use, inadequate maintenance, reparation or
modifications made by unauthorized individuals.
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 the US federal law the Device sale is restricted to licensed medical practitioners or clinicians or
under their approval.
NeoMedLight declares that the Device complies with the European Directive 93/42/EEC.
The CE mark was obtained and the Device was launched in 2016.
This product is to be handled with care and to be processed separately from consumer
waste. Waste of Electrical and Electronic Equipment (WEEE) can pollute the environment
and the product is to be disposed of according to its specific Directive 2012/19/EU and
following the appropriate paths.
Contact the local authorities or the supplier to determine the proper method of disposal of
potentially biohazardous parts and accessories.
a
The term “System” is not used in this document with the meaning given by the standard EN 60601-1, definition 3.64. It stands for the group
of interconnected parts which compose the medical device.
