Fahl 46480, Instructions For Use Manual

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3. INTENDED PURPOSE
The speaking valves enable spontaneously breathing tracheotomised patients with a partially
or fully preserved larynx to speak without having to use their fingers in the presence of a trache -
ostomy tube with voice option or a tracheostomy patch.
It filters the breathing air, thereby reducing intrusion of particles into the patient's airways.
Speaking valves with an O
2
connection also allow the supply of additional oxygen via the inte -
grated O
2
connection.
4. INDICATION
Speaking valves are indicated for spontaneously breathing tracheotomised patients with a par -
tially or fully preserved larynx.
5. CONTRAINDICATION
N
WARNING!
Tracheostomy tubes with a HUMIDOPHONE
®
must not be used on any account by lar -
yngectomised patients, as this could lead to serious complications, even suffocation!
Use in patients with strong exsiccosis (dehydration), or excessive secretion and water accumu -
lation in the lungs and airways (left-ventricular heart failure, pulmonary oedema), or strong air
leakage flow (exhaled air not flowing through the filter cassette) is not permissible.
6. COMPLICATIONS AND ADVERSE REACTIONS
N
WARNING!
The HUMIDOPHONE
®
must be removed before going to sleep to prevent potential ob -
struction of the airways!
N
WARNING!
Prior to using a HUMIDOPHONE
®
, the cuff of the tracheostomy tube must be complete -
ly free of air.
7. PRODUCT DESCRIPTION
The HUMIDOPHONE
®
is a speaking valve as well as a particle filter, consisting of a foam filter
and a plastic housing as well as of a lid with valve function.
The plastic housing is equipped on the patient side with a standardized opening, thereby allow -
ing for connection to a fenestrated/sieved tracheostomy tube.
During inhalation, the valve diaphragm of the HUMIDOPHONE
®
opens and the inhaled air
flows through the foam filter element.
After inhalation, the valve closes, thereby enabling the user to speak.
The pressure rise during expiration supports the valve closure process.
HUMIDOPHONE
®
- On the patient side, the plastic housing is equipped with a central opening
with 22 mm external diameter, thereby allowing for connection to a 22 mm receptacle system.
HUMIDOPHONE
®
TYP 15 - On the patient side, the plastic housing is equipped with a central
opening with 15 mm internal diameter, thereby allowing for connection to a 15 mm standard
connector.
HUMIDOPHONE
®
PLUS - On the patient side, the plastic housing is equipped with a central
opening with 15 mm internal diameter, thereby allowing for connection to a 15 mm standard
connector.