(**) NOTE 2: 50% by volume of atomized particles
from the ampoule is smaller than the Mass Median Aerodynamic Diameter
(MMAD). This value indicates the ability of the ampoule to produce small particles:
clinical studies have shown that the efficacy of the ampoule is measured by the
ability to nebulize the medicinal product into particles with a diameter of between
1 and 5 microns to allow maximum deposition on the lungs, thus increasing the
effectiveness of the treatment.
The specified MMAD values were detected with the Malvern Spraytec tool.
The diagrams provide in order the percentage of the volume of spray solution
transported by particles with a diameter of less than the corresponding value in
pm reported in abscissa.
7 - DISPOSAL OF ALVEA AMPOLLE
All parts must be disposed of in accordance with current regulations on plastic
containers. The table shows the plastics used. All materials used do not contain
phthalates and natural latex was not detected.
PART
MATERIAL
Upper body (1)
Polypropylene
Atomizer (2)
Polypropylene
Lower body (3)
Polypropylene
Lid (4)
Polypropylene
Inhalation valve (5)
Silicone
Exhalation valve (6)
Silicone
Mouthpiece (7)
Polypropylene
Adult mask (8)
Silicone
Paediatric mask (9)
Silicone
8 - OPERATING CONDITIONS
- temperature from +5°C to +40°C
- relative humidity from 15% to 93%
- atmospheric pressure from 700 hPa to 1060 hPa
9 - STORAGE CONDITIONS
- temperature from -25 °C to +50 °C
- relative humidity less than 93%
- atmospheric pressure from 700 hPa to 1060 hPa
ENGLISH • ENGLISH • ENGLISH • ENGLISH • ENGLISH • ENGLISH • ENGLISH • ENGLISH • ENGLISH •
Summary of Contents for alvea basic
Page 2: ...A 1 8 7 9 2 4 5 6 B D 3...
Page 3: ...C C 1 C 2 C 3...
Page 34: ...3 2 2 10 Alvea 3 3 121 15 30 20 4 Alvea Alvea 5 2 1 1 3...
Page 38: ...1 3 1 1 1 93 42 1 2 alvea...
Page 39: ...1 3 93 42 7 6 1 4 1 5 A 1 1...
Page 40: ...3 5 6 4 7 8 9 3 2 6 3 2 1 3 B 1 3 C 1 5 6 4 4 1 C 2 8 9 7 C 3 8 7...
Page 41: ...6 D 9 D 3 7 8 9 1 3 4 1 4 1 3 3 1 40 C 3 2 2...
Page 42: ...10 3 3 121 C 15 30 20 4 5 2 1 1 3...
Page 43: ...8 9 D 6 2 200 3 300 7 15 9 0 20 0 45 3 6 3 2 7...
Page 45: ...7 8 9 8 5 C 40 C 15 93 700 1060 9 25 C 50 C 93 700 1060 10 2 11 I 12...
Page 46: ...1 3 1 1 1 Alvea Alvea EEC 93 42 Alvea CE alvea CE 1 2...
Page 48: ...2 Alvea 6 3 Alvea 1 2 C 1 3 1 4 6 5 C 2 1 4 C 3 1 7 9 8 8 7 6 9 3 Alvea...
Page 49: ...Alvea 4 3 1 9 8 7 1 4 3 1 3 1 40 3 2 10 Alvea 2 3 3 15 121 20 30 4 Alvea Alvea...
Page 50: ...5 2 1 3 1 3 9 8 D 6 200 2 300 3 7 15...
Page 51: ...9 0 20 0 45 3 6 MMAD 3 MMAD 0 9 1 50 2 MMAD 5 1 7 2 15 3...
Page 53: ...11 Air Liquide Medical Systems S r l 12 Air Liquide Medical Systems S r l...
Page 54: ......
Page 55: ......