Instructions for Use :
BiliCocoon™ Phototherapy System
IFU-BCC-SY-EnFr-2017-10-v13
4
EN
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Fluid balance
: Photothe
rapy can affect the patient’s fluid balance. Regularly monitor the
patient’s fluid balance and take appropriate measures to maintain this balance during
phototherapy.
Note
: The Bilicocoon bag system does not create sweating, however if sweating occurs it can hardly be
evacuated which can cause discomfort to the patient. To maximize the patient’s comfort in the Bilicocoon
bag system we recommend, in case of sweating, to open the device laterally on one or both sides or to
leave the patient’s arms outside of the device
Warning
Side Effects for Caregivers and People near the Device
Prolonged exposure to the phototherapy device
’s blue light may cause discomfort to caregivers
such as eye irritation, nausea, headaches or dizziness. Caregivers, staff and others who are in
close proximity to the Device could be sensitive to blue light and need to protect their eyes.
Warning
Risk of Glare
Do not look at the light source (Pad Connection Port) when the Device is switched ON and the
Pad is not connected.
Hot Surface
– Risk of burning
When disconnected, the Pad and Light Box connecting surfaces will be hot. There is indeed a
risk of burning (see section 5).
Warning
Cutaneous Reactions
Cutaneous eruptions such as erythema may occur in infants treated with phototherapy.
Warning
Skin Color Changes
Blue light may hinder clinical observation by masking skin color changes, such as cyanosis.
Warning
Rare Allergic Reactions
Despite the biocompatibility evaluation tests conducted in accordance with the state of the art,
rare allergic reactions may nevertheless occur.
Warning
Variation of the Ambient Conditions
Variations of the ambient conditions (room temperature and humidity, sun exposure, nearby
devices) may unfavorably affect the patient
’s health, including their temperature or their fluid
balance.
Moreover, use of this device outside of the given operating conditions may compromise the
product functionality.
Warning
Reflective Foils
Never use reflective foils to increase the effectiveness of phototherapy treatment, it may
hazardously increase the body temperature.
Warning
Intravenous drugs and fluids
In order to prevent photochemical modifications, do not store drugs and infusion liquids in the
radiation area.
Warning
Combustible gases and flammable solutions
Do not use the BiliCocoon™ phototherapy system in oxygen-rich environments or in the
presence of combustible gases, such as nitrous oxide, anesthetics or any other combustible or
flammable product.
Warning
Labels Integrity and Readability
In case labels are degraded, the information addressing the safety of the patient, users, third
parties, and properties can be found in this document. Contact the supplier if information
concerning the identification of the product or of associated products is not visible anymore.
Make sure that there is no entanglement of the cord or cable at any time.
