Instructions for Use :
BiliCocoon™ Phototherapy System
IFU-BCC-SY-EnFr-2017-10-v13
3
EN
Caution
It indicates a risk of damage to the Device
Warning
Prerequisites
The BiliCocoon™ phototherapy system must only be used by clinicians who are qualified and
aware of the treatment- and device-associated risks and benefits; or by laypersons who are
properly trained and supervised by these clinicians.
Home Use:
see section 6 of these Instructions for Use.
The BiliCocoon™ phototherapy device is not to be used for other medical indications or on
different body parts than those recommended. Improper use may lead to an ineffective
treatment (i.e. no benefits) or to potential risks to the patient's health (adverse events).
Warning
Duration of Session:
Use the device only for the time prescribed. A use that does not take into account the treatment
plan may lead to an ineffective treatment or to potential risks to the patient's health
Warning
No modification of
the BiliCocoon™ Phototherapy System is allowed
. Do not use any
accessories, detachable parts and materials not described in these instructions for use.
The use of a System which has been modified in terms of performances or by replacing its
parts
disregarding the manufacturer’s indications may lead to risks to the patient (e.g. adverse
events), the user, other peoples or properties.
Warning
Intensive
phototherapy (>30 μW∙cm
-2
∙nm
-1
) may not be adapted to all infants (e.g. preterm
infants with a weight ≤1000 g)
Warning
Blocking the light source or reducing the exposed body surface should be avoided
Warning
Contraindications
The BiliCocoon™ phototherapy device must not be used:
o
On patients with congenital porphyria
o
On patients with family history of porphyria
o
In conjunction with drugs or agents that are photosensitizers
o
On patients requiring a sterile environment or equipment and/or who present with
skin lesions.
A use that does not take into account these contraindications may lead to an ineffective
treatment (i.e. no benefits) or to potential risks to the patient's health (e.g. adverse events).
Warning
Eye Protection
Prolonged exposure to phototherapy light may cause damage to the eyes. The use of the
BiliCocoon
™ Phototherapy System without suitable protection of the infant’s eyes may lead to
risks to the infant
’s health, including retinal damage. Eye protection should be used for other
patients who are close to the phototherapy device.
Warning
Patient monitoring during the phototherapy treatment
-
Bilirubin level
: The infant
’s bilirubin level should be regularly measured during the
phototherapy treatment in accordance with the recommendations of the physician in
charge.
-
Temperature
: P
hototherapy can affect the patient’s body temperature. The infant’s
temperature must be monitored according to the recommendations of the physician who is
responsible for the therapy. Because the phototherapy treatment may increase the body
temperature, not controlling the infant
’s temperature may lead to a risk to the patient.
