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inhealth Blom-Singer Instructions For Use Manual page 7

Indwelling voice prostheses for primary, secondary, replacement tep procedures
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Blom-Singer® Indwelling Voice Prostheses
Care should be exercised when inserting or removing cleaning
devices to avoid accidental displacement of the voice prosthesis
which could result in aspiration of the voice prosthesis.
Voice Prosthesis Leakage
When the flap valve fails to close completely a few drops of fluid
may pass back through the valve from the esophagus to the
trachea, which may cause coughing. Recurrent leakage of the
voice prosthesis should be evaluated.
Gentle handling and pressure should always be used when
cleaning the voice prosthesis to avoid deterioration of the device
and damaging internal components which could cause leakage.
Microbial Growth
Most users have microbial growth in their mouth, throat, or
esophagus; this is a commonly occurring condition. Microbial
growth deposits can cause valve deformation and failure, i.e.,
liquid leakage through the voice prosthesis and an increase in the
pressure necessary to voice. Replacement of the voice prosthesis
may be required.
Device Removal
The attached neck strap on an indwelling voice prosthesis should
only be removed after the esophageal retention flange placement
within the esophagus has been verified. Never attempt to insert
or reinsert an indwelling voice prosthesis that has the neck strap
removed.
Never remove one indwelling voice prosthesis and insert another
voice prosthesis without first dilating the TE puncture and re-
measuring the tract to confirm correct voice prosthesis length.
The patient should never attempt to remove the device or allow
anyone other than a qualified, trained medical professional to
remove the indwelling voice prosthesis.
The indwelling voice prosthesis is not a permanent device and
requires replacement periodically.
The indwelling voice prosthesis may be left in place in the TE
puncture until it ceases to function correctly, that is, until it has
persistant leakage or is not providing adequate voice for speech.
37640-05H | 7

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