NeoMedLight BiliCocoon Bag System, Инструкция по эксплуатации

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Instructions for Use :
BiliCocoon™ Phototherapy System
IFU-BCC-SY-EnFr-2017-10-v13
22
EN
5.F Maintenance Operations
Warning
DO NOT ATTEMPT TO REPLACE the LEDs at their end of life, neither by identical LEDs
nor by a different component. CONTACT YOUR SUPPLIER.
Important
If the irradiance value is out of the specified range it should be reset: contact the authorized
technical staff of the hospital or the supplier
Caution
The dust filter may only be changed by authorized technical staff of the hospital or of the
supplier
-
Following the
communication of “overheating”.
- During the annual preventive maintenance.
Caution
The fuse may only be changed by authorized technical staff of the hospital or of the supplier
- Following a system failure event.
-
During the annual preventive maintenance.
Warning
Failure to perform the required preventive maintenance (i.e. periodic verifications of the
system) by the authorized technical staff of the supplier may cause:
- System
’s failures
-
Settings drifts
- Malfunctions
which could create risks to the patient, the user, third parties or properties.
Important
The following risks may occur in the event the user does not perform preventive maintenance
(i.e. cleaning) as recommended or at an insufficient rate:
- Device deterioration
- Non-optimal operation of the Device
Warning
The failure to perform the required corrective maintenance by authorized technical staff of
the hospital or the supplier, may cause failures or malfunctions that may in turn create risks
to the patient, user, third parties or properties.
6 HOME USE
RECOMMENDATIONS FOR CLINICIANS
Warning
The medical staff is in charge of the home user training regarding the verification of the
patient and of the system proper functioning, and regarding all other operations related to
the use of the BiliCocoon™ System.
The user must be trained before the first use of the System about its setup and use and
become aware of the device-associated risks.
Clinicians remains in charge of the verification (e.g. irradiance) and of the cleaning of the
Device.
RECOMMENDATIONS FOR THE HOME USER
Warning
The home user must follow the recommendations and instructions contained in the
instructions for use
– concerning the System and the disposable – and provided by clinicians.
In case of Device malfunctioning the home user must stop the Device and contact the
clinicians.