8
EN
I. Foreword
These instructions for use are valid for
LARYVOX
®
Hands-Free
speaking
valves. The 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 adjustable
LARYVOX
®
Hands-Free Valve
enables patients with partially
or fully preserved larynx as well as persons wearing voice prostheses (shunt
valve) to speak without having to use their fingers. The
LARYVOX
®
Hands-
Free Valve
consists of a plastic housing, a silicone diaphragm disc and a
flexible housing ring, with which the closing sensitivity of the silicone diaphragm
can be adjusted. The valve is intended for use exclusively in combination with
a phonation cannula with 22 mm adapter as well as with LARYVOX
®
Tape
base plates.
When used for the first time, the products must be selected, employed and
inserted by physicians or medical professionals trained in their use, and the
user must be instructed in this regard by such medical professionals.
III. Warnings
• Speaking valves are single-patient products and are thus intended
exclusively for use by
one
patient only. They can be used several times by
the same patient.
• Re-use of any kind in
other
patients and thus also reconditioning for re-use
in
other
patients is not allowed.
• Clean the
LARYVOX
®
Hands-Free
speaking valves only with cleaning
agents approved by the manufacturer.
• The
LARYVOX
®
Hands-Free Valve
cannot be sterilised.
• Heating to over 65°C, disinfection with boiling water or steam sterilisation are
not allowed and lead to damage of the speaking valve.
VI. Complications
• If hands-free speaking is not possible for you despite the largest possible
diaphragm setting, or if you find hands-free speaking difficult logopaedic
training may be necessary. Please consult your physician.
• If the pressure is too high, e.g. if you are coughing, the valve diaphragm
(silicone diaphragm disc) may be forced through the opening in the front
plate (housing ring), accompanied by the sound of rapidly escaping air. If this
happens, pull the entire speaking valve away from the cannula/base plate
and with your fingertips return the valve diaphragm carefully to the original
position. Especially if you need to cough, you should always remove the
speaking valve to prevent the diaphragm from sticking and thus impairing
the function.
LARYVOX
®
HANDS-FREE VALVE
