Instructions for Use :
BiliCocoon™ Phototherapy System
IFU-BCC-SY-EnFr-2017-10-v13
2
EN
1 PRODUCT DESCRIPTION AND APPLICATION
1.A Description
The BiliCocoon
™ System is a phototherapy system designed to treat unconjugated hyperbilirubinemia in the
infant. It is a phototherapy device as defined by EN 60601-2-50, which emits light in the absorption spectrum of
the bilirubin, from 430 to 490 nm
b
, thus reducing the bilirubin concentration in the body of infants.
1.B Intended use of the Device
The BiliCocoonTM Phototherapy System is intended for the treatment of unconjugated hyperbilirubinemia
c
; 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.
1.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
d
.
-
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
Types of Safety Precautions
Warning
It informs of a danger or a hazard for the infant or the operator.
Important
It mentions the actions required to obtain the expected clinical results.
b
96% of light emission is in this wavelength range.
c
The Device is not designed to treat cholestatic jaundice.
d
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.
