Technical Specifications; Packaging Disposal - FLAEM RF6 Basic 2 Mode D'emploi

TECHNICAL SPECIFICATIONS

RF6 Basic Nebulizer
2
In compliance with 93/42/EEC Directive
Minimum fill volume: 2 ml
Maximum fill volume: 8 ml
APPLIED PARTS
The applied parts of type BF are:
patient accessories (1, 2, 3, 4, 5, 6, 7, 8, 9)
Ope-
FLAEM
rating
compres-
pressure
sor range
(bar)
F400 0.60
F700 -
0.80
F1000
(1) Data shown is in accordance with Flaem Nuova internal procedure I29-P07.5. Dispensing speed
values may vary according to the patient's respiratory capacity.
(2) In vitro testing performed by TÜV Rheinland Italia S.r.l. in collaboration with the University of
Parma and in compliance with the EN 13544-1: 2007 + A1 European Standard for aerosol therapy
devices Standard. More details are available on request.
SYMBOLS
EC Marking medical ref. Dir 93/42 EEC
and subsequent updates
In compliance with: European Standard
EN 10993-1 ''Biological Evaluation
of medical devices'' and European
Directive 93/42/EEC "Medical Devices. "
Phthalate-free. In compliance with:
Reg. (EC) no. 1907/2006

PACKAGING DISPOSAL

Product packaging bag and Tube packaging
04
bag
LDPE
Operating conditions:
Temperature: min 10°C; max 40°C
Air humidity: min 10%; max 95%
Atmospheric pressure: min 69KPa; max 106KPa
Storage conditions:
Temperature: min -25°C; max 70°C
Air humidity: min 10%; max 95%
Atmospheric pressure: min 69KPa; max 106KPa
MMAD BREATHABLE FRACTION
(μm) < 5 μm (FPF) %
(2)
3.06
3.32
LOT
10
DELIVERY ml/min
(2)
standard
mode
73.97 0.25
71.91 0.32
Check the instructions for use
Manufacturer
Lot Number
(1)
(approx)
high speed
mode
0.32
0.42
s
d
AC
UT
1
2
3
4
5
6
7
8
9
10
11
12
P
-
-
-
-
IN
Av
dé
L'a
év
de
l'a
l'a
le
av
1.