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INFORMATION ON RESTRICTIONS OR INCOMPATIBILITIES WITH CERTAIN
SUBSTANCES
• Interactions: The materials used in the device are biocompatible materials and comply with
statutory regulations, however possible allergic reactions cannot be completely excluded.
TECHNICAL SPECIFICATIONS
Power supply
Power
Transducer frequency
Noise level (at 1 m)
Appliance dimensions
Nebuliser weight
Pocket dimensions
Delivery ml/min
(1)
MMAD
(2)
Respirable fraction < 5 μm (FPF)
Aerosol Output (AO)
(2)
Aerosol Output Rate (AOR)
Residual volume
(2)
Medicine tray capacity
The nebulising speed has been measured with 0.9% saline at 23° C according to a Flaem internal proce-
(1)
dure. It may vary according to the nebulising head supplied, to the medicine and to the environmental
conditions. The delivery Speed figures may also vary according to the patient's respiratory capacity.
)In vitro characterization performed by TÜV Rheinland Italia S.r.l. in collaboration with the University of
(2
Parma according to EN ISO 27427. Further details are available upon request.
APPLIED PARTS
Type BF applied parts are:
ENVIRONMENTAL CONDITIONS
Operating conditions:
Ambient temperature
Relative air humidity
Atmospheric pressure
Storage and transport conditions:
Ambient temperature
Relative air humidity
Atmospheric pressure
Note: In order to store the batteries appropriately, when not in use for an extended period of time, ex-
tract the batteries from the device and store it in a place in compliance with the above temperatures.
DURATION
The average age of the various components set out below refers to device use for approxi-
mately 10 min a day (2 applications of 5 min. each)
1 Appliance body* - 5 years
3, 4 and 5 Masks and mouthpiece* - 1 year
2.4 - 3Vdc 1.5W 2 x AA alkaline or rechargeable batteries
1.5W
108 KHz +/- 3KHz
40 dBA approx.
5.0(L) x 6.2(D) x 13.7(H) cm
(excluding batteries) 115g
19(L) X 15(D) cm
≥ 0.30
3,93 μm
61.3% approx
(2)
0.701 mg
0.172 mg/min
(2)
< 0.2 ml
10 ml
patient accessories (3, 4, 5)
2 Tank tray and mesh unit* - 1 year
* see next page for reference
26
Between +10°C and +40°C
Between 10% and 75%
Between 69KPa and 106 KPa
Between -10°C and +35°C
Between 10% and 75%
Between 69KPa and 106 KPa
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