User manual:
BiliCocoon™ Fixation System
IFU-BCC301-EnFr-2017-04-v03 Page 5
EN
1. PRODUCT DESCRIPTION AND APPLICATION
A. Description
The fixation system
– or BiliCocoon™ Fixation System – is a fixation system designed for exclusive use with the
BiliCocoon™ System, a medical device offering a treatment solution for unconjugated hyperbilirubinemia in new-born
babies and which uses phototherapy.
The BiliCocoon™ System consists of a light pad connected to a Light Box emitting blue light in the absorption spectrum
of bilirubin, thereby enabling its concentration to be reduced.
For more information, see the BiliCocoon™ System user
manual.
The BiliCocoon
TM
Fixation System should only be operated by caregivers or a person who has been trained by a
qualified trainer.
For more information, see “3. Technical specifications”.
B. Intended use of the Device
The BiliCocoonTM Phototherapy System is intended for the treatment of unconjugated hyperbilirubinemia in the
population of neonates and infants under 3 months old and weighing less than 10kg. It can be used in the clinical
setting or in the home.
C. Additional information
-
Only for the treatment of unconjugated hyperbilirubinemia, which is responsible for the majority of cases of
neonatal jaundice.
-
Only with medical prescription
-
Only for the duration indicated in the treatment protocol
-
Target patient population: neonates and infants
2
.
-
Over the patient's entire body except for genitals and eyes
– eye protection must be worn.
-
To be used with a single patient
-
To be used in hospital or at home: adapted to different environments for use (in an incubator, on a table, in a
cradle, in the arms of a parent or caregiver).
-
Not to be used on damaged skin
2. SAFETY INFORMATION
2
Under 3 months old and weighing less than 10 kg
– definition according to EN 60601-2-50. The term “infant” used in this
document is used in compliance with this definition according to EN 60601-2-50.
