Technical Specifications; Electromagnetic Compatibility; Disposal Of Device - FLAEM Universal Plus Gebrauchsanweisung

TECHNICAL SPECIFICATIONS

Mod. UNIVERSAL PLUS
NEBULIZER
Power:
Absorption:
Frequency:
Operation:
Automatic switch-off :
Max tray capacity :
Max. operating speed
(2)
MMAD :
(1) Tests performed with phys. sol. 0.9% NaCl according to Flaem internal procedure.
(2) Certified with TSI Aerosizer 3220 computerized laser system according to Flaem internal procedure.
Noise (at 10 cm):
Dimensions:
Weight:
In conformity with:
Dimensions of bag:
Weight of bag:
(complete with appliance and accessories)
APPLIED PARTS
The BF type applied parts are:
Operating conditions:
Storage conditions:
Operating/storage atmospheric pressure:
POWER SUPPLY UNIT
Use only power supply unit code 17532
Primary:
Secondary:
Dimensions:
Weight:

ELECTROMAGNETIC COMPATIBILITY

This device was designed to satisfy the currently required requisites for electromagnetic
compatibility (EN 60601-1-2). 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. 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. The Medical Device may
be subject to electromagnetic interference if other devices are used for specific diagnosis
or treatments. Flaem reserves the right to make technical and functional modifications to the
product with no prior warning.

DISPOSAL OF DEVICE:

In conformity with Directive 2012/19/EC, the symbol shown on the device to be disposed
of indicates that it is considered as waste and is therefore subject to "sorted waste
collection". The user must therefore take (or have taken) the above waste to a pre-sorted
waste collection centre set up by the local authorities, or else give it back to the dealer
when purchasing a new appliance of the same type. Pre-sorted waste collection and the subsequent
treatment, recovery and disposal operations favor the production of appliances made of recycled
materials and Iimit the negative effects of any incorrect waste management on the environment and
public health. The unlawful disposal of the product by the user could result in administrative fines
as provided by the laws transposing Directive 2012/19/EC of the European member state or of the
country in which the product is disposed of.
(1)
:
15V
850 mA
2.4 MHz
30 min ON/ 30 min OFF
after 10 minutes
6 ml.
0.7 ml/min approx
1.9 μm
< 50 dB(A)
9x5x12h cm
200 g
0051
20x13x13h cm
1 Kg
patient accessories (C1, C2, C3, C4)
Temperature: min 10°C; max 40°C
Air humidity: min 10%; max 95% RH
Temperature: -25°C; max 70°C
Air humidity: min 10%; max 95% RH
min. 690 hPa; max. 1060 hPa P
100-240V ~ 50/60Hz
15V 1A
10x7x9 cm
510 g
14