Packaging Disposal; Device Disposal; Electromagnetic Compatibility - FLAEM PRO LINE PulmoWaves 2 Instrucciones Para El Uso

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SYMBOLS
CE Marking medical ref. Dir EEC
93/42 and subsequent updates
Class II device
Attention: check the instructions for use
"ON"
"OFF"
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
OUT
Output power supply for Nebulizer Device. (Mod.
12V
P0112EM).
Temperature limit

PACKAGING DISPOSAL

05
Heat shrink film accessories
PP

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
subsequent 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 man-
agement. 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
When the device is turned
off, the switch interrupts
compressor operation only
on one of the two power
supply phases
Device serial number
Manufacturer
Type BF applied part
Degree of protection of the casing: IP21.
IP21
(Protected against solid foreign objects larger than
12mm. Protected against access with a finger;
Protected against vertically dripping water).
Keep dry
Alternating current
Humidity limit
Atmospheric pressure limit
Product packaging bag and tube packaging
04
bag
LDPE
g.
20

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