SYMBOLS
Certification TÜV
CE Medical Marking ref. Dir. 93/42
EEC and subsequent amendments
Serial number of device
Class II device
Manufacturer
Important: check the operating
instructions
Type BF applied part
“OFF” for part of equipment
Alternating current
“ON” for part of equipment
Hazard: electrocution.
Consequence: Death.
Do not use device while taking a bath
or shower
Complies with: European standard
EN 10993-1 “Biological Evaluation
of Medical Devices” and European
Directive 93/42/EEC “Medical
Devices”. Phthalates free. In
conformity with Reg. (EC) no.
1907/2006
IP21
Enclosure protection rating: IP21.
(Protected against solid bodies over
12 mm. Protected against access with
a finger;
Protected against vertically falling water
drops.)
Minimum and maximum room
temperature
Minimum and maximum air moisture
Minimum and maximum
atmospheric pressure
ELECTROMAGNETIC COMPATIBILITY
This device was designed to satisfy the currently required requisites for electromagnetic
compatibility (EN 60601-1-2:2015). 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. The Medical Device may be subject to
electromagnetic interference if other devices are used for specific diagnosis or treatments.
For further information visit our website www.nuvitababy.com. The Manufacturer reserves
the right to make technical and functional modifications to the product with no prior
warning.
TECHNICAL FEATURES
Nuvita 5022
(Mod.: P0207EM F400)
Voltage:
230V~ 50Hz
130VA
115V ~ 60Hz
220V ~ 60Hz
Safety certifications:
Max pressure:
Compressor air output:
Sound level (at 1 m):
Operation:
1.8 ± 0.3 bar
9 l/min approx
54 dB (A) approx
Continuous use
Operating conditions:
Temperature:
RH Air humidity:
Atmospheric pressure:
min 10°C; max 40°C
min 10%; max 95%
min 69KPa; max 106KPa
Storage conditions:
Temperature:
RH Air humidity:
Atmospheric pressure:
min -25°C; max 70°C
min 10%; max 95%
min 69KPa; max 106KPa
Dimensions (W)x(D)x(H):
Weight:
16x16x13 cm
1.300 Kg
APPLIED PARTS
Type BF applied parts are:
patient accessories (C2, C3,C4, C5)
RF7 Dual Speed nebulizer
Medication minimum capacity:
Medication maximum capacity:
Operating pressure (with neb.):
2 ml
8 ml
0.65 bar
Speed selector C1.4
Max
Min
(1)
Delivery:
0.55 ml/min approx.
0.25 ml/min approx.
(2)
MMAD:
4.58 μm
3.78 μm
(2)
Breathable fractions < 5 μm (FPF):
54.4%
63%
(1) data detected according to I29-P07.5 internal procedure
(2) In vitro testing certified by TÜV Rheinland LGA Products GmbH - Germany in compliance with the European
Standard EN 13544-1 for nebulising systems. Further details are available upon request.
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 an item of ''differentiated collection''. Consequently, the user must take it (or
have it taken) to the designated 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 management. 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.
