Instructions for Use :
BiliCocoon™ Phototherapy System
IFU-BCC-SY-EnFr-2017-10-v13
8
EN
LEDs
Characteristics
6 LEDs of 15 W max power and emitting between 400 and 550 nm
Lifetime
The
BiliCocoon™ System has an expected lifetime of at least 8000 h, corresponding to
approximately 7 years of regular use at ambient temperature.
Sound Level
f
37 dB(A) at 1 meter
Environmental Conditions
Warning
Disregarding the operating and storage conditions may lead to the Device deterioration and
failures, therefore creating risks to the patient, the users, third parties or properties.
IP21 protection for the Light Box: protection against the ingress of solid objects larger than
12.5 mm
– e.g. a finger won’t have access to a hazardous part – and of dripping water –
vertically falling drops won’t have harmful effects. Although the shell provides protection
against liquid ingress, the user must take precautions to avoid the contact of the Device with
liquids, which could cause an electrical hazard.
IPX3 protection for the Pad: protection against the ingress of solids of all size and the ingress
of direct sprays of water up to 60° from vertical
– in these conditions the water ingress won’t
have harmful effects. Although the enclosure provides protection against liquid and solid
ingress, the user must take precautions to prevent the infiltration of fluids, especially in the
Connection.
Do not place the system close to a source of
radiant heat flow
(e.g. radiant warmer).
It may
impact the proper functioning of the BiliCocoon
™ system.
Do not place the system close to a source of moisture like a nebulizer or a steam kettle. The
moisture may affect the Light Box proper functioning and safety.
Risk of electric shock
.
Avoid exposure to
environments with excessive dust.
Lint and dust may settle in the Light
Box or on the surfaces meant to transfer blue light: the consequence would be an improper
functioning of the System and/or the deterioration of its performances.
Operating Conditions
Warning
INDOOR use only. The Device is not be used while in motion.
The Pad and the disposable can be placed in the incubator with the infant. The Light Box
must be placed outside the incubator.
Temperature range: from 10 to 35°C
g
Relative humidity range: from 15 to 90%, without condensation
Atmospheric Pressure range: from 700 to 1060 hPa
h
Ensure that the air inlets are not covered or obstructed in order to avoid the Light Box
overheating.
The power supply to be used is the
MEGMEET MANGO100-12B
. The use of a different
power supply may lead to risks to the patient, users, third parties, or properties.
Storage Conditions between uses
Warning
INDOOR storage only
– do not leave the system exposed to the sun. A prolonged exposure
to sun light may lead to the deterioration of the Pad optical
fibers and to the system’s
performances.
Temperature range: from -25 to 50°C
i
Relative humidity range: from 10 to 90%, without condensation
Atmospheric Pressure range: from 700 to 1060 hPa
f
Value of sound pressure.
g
50 - 95 °F
h
Equivalent Altitude : 0
– 3000 m (0 – 9842.52 feet)
i
-13
– 122 °F
