FLAEM NebulFlaem 4.0 Manual Del Usuario página 16

DISPOSAL
Compressor unit
In accordance with Directive 2012/19/EC, the symbol on the equipment indicates that the
equipment to be disposed of (excluding accessories) is considered as waste and must therefore
be subject to 'separate collection' . Therefore, the user must deliver this waste (or have it
delivered) to the separate collection centres set up by the local authorities, or hand it over to
the retailer when purchasing a new appliance of an equivalent type. Separate waste collection and
subsequent treatment, recovery and disposal operations promote the production of equipment
from recycled materials and limit the negative environmental and health effects caused by improper
waste management. Unauthorised disposal of the product by the user entails the application of the
administrative sanctions provided for in the laws transposing Directive 2012/19/EC of the member state
or country where the product is disposed of.
Nebuliser and accessories
To be disposed of as general waste after a sanitisation cycle.
Packaging
20
Product box
PAP
Heat-shrinkable nebuliser film and
05
accessories
PP
NOTIFICATION OF SERIOUS EVENTS
Serious events occurring in connection with this product must be reported immediately to the manu-
facturer and the competent authority.
An event is considered serious if it causes or may cause, directly or indirectly, death or an unforeseen
serious deterioration in a person's state of health.
COUNTRY
Ireland
Malta
04
Product packaging tube
LDPE
AUTHORITY
Health Products Regulatory Authority
Kevin O'Malley House, Earlsfort Centre, Earlsfort Terrace,
IE - Dublin 2
E-mail: devicesafety@hpra.ie
Medical Devices Unit Medicines Authority
Sir Temi Żammit Buildings, Malta Life Sciences Park
San Ġwann SĠN 3000
E-mail : devices.medicinesauthority@gov.mt
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