User manual:
BiliCocoon™ Fixation System
IFU-BCC301-EnFr-2017-04-v03 Page 6
EN
Types of safety advice
Warning
Signals danger or risk of injury for the child or the operator
Important
States the necessary actions for obtaining good clinical results
Warning
Prerequisites
The Device must only be used by qualified medical staff who are fully aware of the risks and
advantages of this type of treatment and this type of apparatus, or by individuals who have been
trained by medical staff.
Use at home:
Before using the Device for the first time, it is vital that home users be trained in
how to install and use the Device, and be made aware of the risks associated with using it. It is of
the utmost importance that they follow the recommendations and instructions provided in the
instructions (system and single use) and by healthcare professionals.
The device must not be used if contraindicated, or for medical indications or parts of the body for
which it is not recommended or authorised. This could either render the system completely
ineffective (no treatment benefits) or could put the patient's health at risk (adverse effects).
Warning
Keep out of reach of children.
Warning
Variation in ambient parameters
Variation in ambient parameters (room temperature and humidity, exposure to sunlight,
surrounding
equipment) may have a negative effect on the child’s health, especially their
temperature or fluid balance.
If the Device is used other than in accordance with instructions, it may malfunction.
Warning
Inflammability
Keep away from flames or sources of ignition.
For more information on
the risks associated with phototherapy, see the BiliCocoon™ System user manual.
Warning
Label integrity and readability
If labels are damaged, you can find information concerning the safety of patients, users, third-
parties
or
property
in
this
document.
Contact
the
supplier
if
information
concerning the identification of the product or of associated products is not visible anymore.
