FLAEM RF6 Basic 2 Mode D'emploi page 14

TECHNICAL DATA
Mod. P0406EM F700
Voltage:
Safety certifications:
Max Pressure:
Compressor air output:
Dimensions (L)x(P)x(H)
Weight
Noise level (at 1 m):
Operation:
APPLIED PARTS
Type BF applied parts include:
RF6 Basic Nebulizer
2
Medication minimum capacity
Medication maximum capacity:
Operating pressure (with neb.)
Delivery:
(1)
MMAD:
(2)
Breathable fractions < 5 μm (FPF):
(2)
data detected according to Flaem I29-P07.5 internal procedure
(1)
In vitro characterization certified by TÜV Rheinland Product GmbH - Germany in compliance with the new European Standard for aerosol therapy
(2)
units, Standard EN 13544-1. Further details are available on request.
NASAL SHOWER SPECIFICATIONS
Mod.: Rhino Clear®
Capacity:
10 ml dispensing time
(1)
MMD
(2)
% <10 μm
(2)
Tests carried out with 0,9% NaCl physiological solution according to Flaem internal procedure
(1)
Data gathered with Laser Malvern Mastersizer system (in a certified laboratory)
(2)
Operating conditions:
Temperature: min 10°C; max 40°C
Air humidity: min 10%; max 95%
Atmospheric pressure: min 69KPa; max 106KPa
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.
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.
230V~ 50Hz 140VA
2.6 ± 0.4 bar
10 l/min approx
21x16x13 cm
1.600 Kg
55 dB (A) approx
Continuous use
patient accessories (C2,C3,C4,C5.1A-C5.1B-C5.1C)
2 ml
8 ml
0.8 bar
drug 10 ml maximum
2'
48 μm
3.2%
115V ~ 50Hz
Mod. High speed
0.42 ml/min approx.
3.6 μm
67%
Storage conditions:
Temperature: min -25°C; max 70°C
Air humidity: min 10%; max 95%
Atmospheric pressure: min 69KPa; max 106KPa
12
220V ~ 50Hz
Mod. standard
0.32 ml/min approx.
3.6 μm
66%