Disposal; Notification Of Serious Events - Flaem Respirair Rf7-2 Mode D'emploi

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
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Product box
PAP
Heat-shrinkable nebuliser film and ac-
05
cessories
PP

NOTIFICATION OF SERIOUS EVENTS

Serious events occurring in connection with this product must be reported immediately to the manu-
facturer or 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 bag and tube
LDPE
02 Packaging bag for accessories bag
HDPE
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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