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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)
(2)
Characterisation* MMAD
(2)
Respirable fraction < 5 μm (FPF)
Medicine tray capacity
(1)
The nebulising speed has been measured with 0.9% saline at 23° C according to a Flaem internal pro-
cedure. It may vary according to the nebulising head supplied, to the medicine and to the environmen-
tal conditions. The delivery Speed figures may also vary according to the patient's respiratory capacity.
(2)
In vitro characterisation performed by TÜV Rheinland Italia S.r.l. in cooperation with the University of
Parma. More details are available on 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
3.7 ÷ 4.6 μm
65% approx
10 ml
patient accessories (3, 4, 5)
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
2 Tank tray and mesh unit* - 1 year
* see next page for reference
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