Device Specifications - FLAEM NUOVA SpA Pro Line Neo Spire P0713EM Instrucciones De Uso

DEVICE SPECIFICATIONS

Mod. P0713EM
Power source:
Fuse:
Compressor air delivery:
Noise (at 1 m):
Operation:
Operating conditions:
Storage conditions:
Operating/storage
atmospheric pressure:
Device dimensions
Weight
APPLIED PARTS
Type BF applied parts are:
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.)
"ON" When the device is turned off,
the switch interrupts compressor op-
eration only on one of the two power
"OFF"
supply phases
In compliance with: European Stand-
ard 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. Conse-
quently, the user must take it (or have it taken) to the differentiated collection sites provided by the local au-
thorities, 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 management. Unauthorised disposal of the product by the user shall result in the application
of administrative penalties, of which article 50 and the subsequent revisions of D. Lsg. N. 22/1997.
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 warning.
230 V ~ 50 Hz / 210 VA
1 x T2A 250V
approx 17 l/min
56 dB (A) (approx.)
Continuous
Temperature min. 10°C; max. 40°C
Relative humidity min. 10%; max 95%
Temperature min. -25°C; max 70°C
Relative humidity min. 10%; max. 95%
min. 690 hPa; max. 1060 hPa
26 (L) x 12 (W ) x 23.5 (H) cm
2.2 Kg
patient accessories (C2)
10
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