Instructions for Use :
BiliCocoon™ Phototherapy System
IFU-BCC-SY-EnFr-2017-10-v13
15
EN
For the Nest Pad
Consider the 8 measuring points as identified below
For the Bag Pad
Consider the 4 measuring points on each
small Pad as identified below (8 measuring
points totally)
12. Calculate the mean value over the eight measures. This value should be in the range defined in the table
below.
Average spectral irradiance (I - µW
∙cm
-
²
∙nm
-1
)
over the eight points
Conclusion
38 < I < 43
m
Optimal Irradiance
n
I < 38 or I > 43
Out of specification
– refer to Section 5.F
“Maintenance Operations”
Important
Refer to section 5.E in case the irradiance value is outside of the defined range and inform
the manufacturer.
Important
The use of a
BiliCocoon™ system with a mean irradiance value exceeding the defined range
upper limit, may deteriorate the Pad
’s optical fibers.
4.D Setup of the Disposable and Positioning of the Infant
Warning
For any information on the Disposable and its use, please refer to the last version of
the Instructions for Use of the
BiliCocoon™ Disposable.
The BiliCocoon™ Disposable is not intended to be used with a phototherapy
treatment system other than the BiliCocoon™.
Warning
The BiliCocoon™ Disposable is a
single use
,
single-patient
medical device. It should be
used respecting the usual hygiene precautions. There is indeed a cross-contamination risk
if the Disposable is used for more than one patient.
Never place the infant directly on the Pad. Always use the Disposable specifically designed
for the BiliCocoon
TM
.
The Disposable is not designed for re-use and should not be cleaned, disinfected, or placed
in contact with the cleaning products used to clean
the BiliCocoon™ Pad.
Not using the disposable or having the cleaning products in contact with the infant may lead
to allergic reactions for the patient.
m
The user should refer to the radiometer instructions for use and take into account its accuracy (±3%).
n
Defined according to
: “
Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation
“, Pediatrics
2004; 114:1 297-316; doi:10.1542/peds.114.1.297, prepared by the AMERICAN ACADEMY OF PEDIATRICS.
