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Medical device
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Single patient – multiple use
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3. INTENDED USE
Purpose
Nebulisers (including compressor, ultrasonic and
mesh nebulisers) are medical devices for the
nebulisation of liquids and liquid medication (aero-
sols). This device produces aerosols by combining
compressed air and liquid medication. The aero-
sol treatment is suitable for treating the upper and
lower airways. By nebulising and inhaling the med-
ication prescribed/recommended by your doctor,
you can prevent diseases a ecting the airways, or
in the case that you contract such an illness, you
can alleviate symptoms and speed up your recov-
ery.
Target group
The nebuliser is only intended for medical care in
a home environment. The nebuliser is not intended
for health care in professional environments. The
nebuliser can be used on anyone over 2 years of
age under supervision; it can be used for self-treat-
ment by anyone over 12 years of age.
The shape of the person's face determines wheth-
er or not the device can be used under supervi-
sion. As such, it may be possible to use the device
under supervision on someone who is younger, or
conversely it may not be possible to use the device
until they are older. When using a mask to inhale,
take care to ensure the mask fits well and the eyes
are unobstructed.
Clinical benefits
Inhalation is the most e ective way to administer
medication for most respiratory system conditions.
The benefits are:
• The medication is transported directly to the
target organs,
• The local bioavailability of the medication is
significantly increased,
• Systemic di usion is reduced substantially,
• Only very low doses of the medication are re-
quired,
• Quick and e ective therapeutic e ect,
• Side e ects are significantly reduced com-
pared to systemic administration,
• Humidifying of the airways,
• Loosening and making (bronchial) secretions
more liquid,
• Releasing bronchospasms (spasmolysis),
• Relieving swollen and inflamed bronchial mu-
cosa,
• Coughing up secretions,
• Fighting viruses that a ect the upper and lower
airways.
Indication
The nebuliser can be used for diseases of the up-
per and/or lower airways. Examples of upper res-
piratory system diseases include:
• Rhinitis,
• Allergic rhinitis,
• Sinusitis,
• Pharyngitis,
• Laryngitis.
Examples of lower respiratory system diseases in-
clude:
• Bronchial asthma,
• Bronchitis,
• COPD (chronic obstructive pulmonary dis-
ease),
• Bronchiectasis,
• Acute tracheobronchitis,
• Cystic fibrosis,
• Pneumonia.
Contraindications
• The atomiser is not intended for the treatment
of life-threatening conditions.
• This device must not be used by children un-
der the age of 12 and by people with reduced
physical, sensory (e.g. reduced sensitivity to
pain) or mental skills or a lack of experience
or knowledge, unless they are supervised or
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