5
EN
HUMIDOPHONE
®
I. FOREWORD
These instructions for use are valid for
HUMIDOPHONE
®
speaking valves with filter function
.
These instructions for use serve to inform the physician, nursing staff and patient/user in order to
ensure technically correct handling. Please read the instructions for use carefully before using the
product for the first time!
II. INTENDED USE
The HUMIDOPHONE
®
enables patients with partially or fully preserved larynx to speak without
having to use their fingers. It filters the breathing air, thereby reducing intrusion of particles into the
patient's airways.
III. WARNINGS
The HUMIDOPHONE
®
is a single-patient product and is intended for single use only. It
must not be cleaned or disinfected, as use of cleaning agent can render the filter unusable.
Sterilisation and reuse impair the function and therefore are also not permissible.
The HUMIDOPHONE
®
must under no circumstances be inserted directly into the
tracheostoma (risk of suffocation!).
Suitable only for patients capable of breathing spontaneously.
Care must be taken to ensure that the valve opening is not blocked by clothing or the like in
order to enable unhindered breathing (risk of respiratory distress).
The HUMIDOPHONE
®
must only be used by patients with partially or fully preserved larynx!
The HUMIDOPHONE
®
must only be used by patients with a clear state of consciousness
and spontaneous breathing!
The HUMIDOPHONE
®
must be removed before going to sleep to prevent potential
obstruction of the airways!
The HUMIDOPHONE
®
may not be used in conjunction with a nebuliser or atomiser. Do not
fill any water into the HUMIDOPHONE
®
. This would invariably entail the risk of increased
respiratory resistance and thus obstruction of breathing.
IV. PRECAUTIONS
If the filter is clogged or if signs of clogging appear, the HUMIDOPHONE
®
speaking valves must
immediately be removed and disposed of.
V. CONTRAINDICATIONS
Tracheostomy tubes with a HUMIDOPHONE
®
must not be used on any account by laryngectomised
patients, as this could lead to serious complications, even suffocation!
Use in patients with strong exsiccosis (dehydration), or excessive secretion and water accumulation
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.
Prior to using a HUMIDOPHONE
®
, the cuff of the tracheostomy tube must be completely free of air.
PICTOGRAMM LEGEND
d
Catalogue number
n
Batch code
P
Consult instructions for use
6
Keep away from sunlight
7
Keep dry
I
Use by
H
Do not reuse
Q
Content (in pieces)
m
Do not use if package is damaged
b
Manufacturer