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37582-01E
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Blom-Singer® Indwelling Valved/Plug Insert
may be used in conjunction with the Blom-Singer Indwelling
voice prosthesis to prevent leakage of fluids through the voice
prosthesis into the trachea during swallowing and to maintain
voice restoration on a temporary basis.
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.
The Blom-Singer Indwelling Valved Insert accessory device is a
medical product and should be used only by individuals with
experience and training in its use and care.
The Blom-Singer Indwelling Valved Insert accessory device is
intended to be temporarily used only as an optional accessory
device with the Blom-Singer Indwelling Voice Prosthesis. It is
not intended to be placed 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.
The Indwelling Valved Insert accessory device is not intended for
use with the Indwelling voice prosthesis size 6mm due to device
size constraints. The Indwelling Valved Insert will not fit properly
into the Indwelling size 6mm.
Use of the Blom-Singer Adjustable Tracheostoma Valve (ATSV) is
contraindicated (must not be used) when the Indwelling Valved
Insert is placed within the Indwelling voice prosthesis. Use of the
ATSV may result in accidental displacement of the Indwelling
Valved Insert or Indwelling voice prosthesis which could result
in aspiration (inhaling) of the valved insert or voice prosthesis.
HOW SUPPLIED
The Blom-Singer Indwelling Valved Insert and Plug Insert are
supplied separately as accessory devices for use with a Blom-
Singer Indwelling voice prosthesis. An inserter tool is included