Blom-Singer Plug Insert; Contraindications - inhealth Blom-Singer Gebrauchsanweisung

ENGLISH
BLOM-SINGER® PLUG INSERT
Introduction
Please refer to the diagrams located at the back of this instruction
manual. A glossary of terms appears at the end of this chapter.
These products are intended for single patient use only.
Not for use between patients. See Warnings, Precautions and
Complications.
INDICATIONS
The Blom-Singer Plug Insert may be used on a temporary basis
in conjunction with a Blom-Singer indwelling voice prosthesis to
prevent leakage of fluids through the voice prosthesis into the
trachea during swallowing.

CONTRAINDICATIONS

The Plug Insert is a medical product and should be used only
by individuals with experience and training in its use and care.
The Plug Insert is not intended to permanently replace a properly
functioning voice prosthesis. It is not intended to be placed
directly in a surgically created fistula between the esophagus
and trachea. It is not intended to be used in combination with
any other voice prosthesis or device other than the Blom-Singer
ADVANTAGE or CLASSIC Indwelling Voice Prostheses.
Warning: Use of all tracheostoma accessories is
contraindicated (must not be used) when the Plug Insert
is placed within the voice prosthesis. Use of tracheostoma
accessories in conjunction with the Plug Insert may result in
accidental displacement of the device or voice prosthesis,
which could result in inhalation of the device or voice
prosthesis.
Do not use the Plug Insert with a 4 mm size voice prosthesis.
The Plug Insert will not fully insert into a 4 mm size voice
prosthesis. This could result in pushing the voice prosthesis
into the esophagus.
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