Device Disposal; Electromagnetic Compatibility - FLAEM NUOVA Pro Line PulmoWaves Instrucciones De Uso

SYMBOLS
Class II device
Attention: check the instructions for use
Degree of protection of the casing: IP21.
(Protected against solid foreign objects
larger than 12mm. Protected against
access with a finger; Protected against
vertically dripping water.)
When the device is turned off,
"ON"
the switch interrupts compressor
operation only on one of the two
"OFF"
power supply phases
In compliance with: European Standard EN
10993-1 ''Biological Evaluation of medical
devices'' and the European Directive 93/42/
EEC ''Medical Devices'' . Phthalate-free. In
compliance with: Reg. (CE) no. 1907/2006

DEVICE DISPOSAL

In compliance with the Directive 2012/19/EC, the symbol printed on the device shows that the device
to be disposed of is considered waste and must therefore be a "separate collection" item. Consequently,
the user must take it (or have it taken) to the differentiated collection sites provided by the local authorities, or
turn it in to the dealer when purchasing an equivalent new device. Differentiated waste collection and the sub-
sequent treatment, recycling and disposal procedures promote the production of devices made with recycled
materials and limit the negative effects on the environment and on health caused by potential improper waste
management. If the user disposes of the product in an unauthorised fashion, administrative penalties will be
applied according to the transposition laws of directive 2012/19/EC of the member state or country where the
product will be disposed of.

ELECTROMAGNETIC COMPATIBILITY

This device was designed to satisfy the currently required requisites for electromagnetic compatibility (EN
60601-1-2:2007). Electro-medical devices require particular care during installation and use relative to EMC
requirements. Users are therefore requested to install and/or use these devices following the manufacturer's
specifications. There is a risk of potential electromagnetic interference with other devices, in particular with
other analysis and treatment devices. RF mobile or portable radio and telecommunications devices (mobile
telephones or wireless connections) can interfere with the functioning of electro-medical devices. For further
information visit our website www.flaemnuova.it or www.flaem.it
Flaem reserves the right to make technical and functional modifications to the product with no prior warnin
17040A0_ interno.indd 8
Type BF applied part
Alternating current
CE Marking medical ref. Dir EEC
0051
93/42 and subsequent updates
Risk: electrocution.
Consequence: death.
Do not use the device while
taking a bath or a shower
Manufacturer
Device serial number
Power output
OUT
for ultrasonic nebuliser
15VDC
8
g.
13/07/2016 15:00:55