inhealth BLOM-SINGER Gebrauchsanweisung Seite 7

Blom-Singer ® Patient-changeable Voice Prostheses
evaluations not longer than 6 months from initial placement.
Caution: Federal (USA) law restricts this device to sale by or on
the order of a physician.
COMPLICATIONS
Although rare, the following complications have been identified
to occur with silicone prostheses of the Blom-Singer type. They
include: stoma contamination or sepsis, which may require
removal of the voice prosthesis and/or appropriate antibiotics;
accidental aspiration of the voice prosthesis into the airway,
which may require removal by a physician; occasional extrusion
of the prosthesis, requiring replacement after dilation of the TE
puncture and additional supervision of the stoma care regimen;
puncture dilation resulting in leakage of fluids around the
voice prosthesis; inflammatory reaction around the puncture
site and formation of granulation tissue; dislodgment of the
voice prosthesis and subsequent closure of the TE puncture;
unmanageable leakage around the voice prosthesis, requiring
surgical revision or closure of the puncture; dysphagia, or
difficulty swallowing; tearing or other damage to the voice
prosthesis from improper use; microbial growth deposits causing
leakage through the voice prosthesis or valve incompetence;
accidental ingestion of the voice prosthesis into the esophagus
and/or GI tract.
INSTRUCTIONS FOR USE
Please refer to the diagrams located at the back of this instruction
manual.
Your clinician will instruct you on the use and routine care of the
Blom-Singer voice prosthesis.
Caution: Use only InHealth Technologies® cleaning devices. Do
not insert foreign objects into voice prosthesis. Inserting objects
other than the InHealth Technologies® cleaning devices may
cause dislodgment of the voice prosthesis or its components.
Warning: Care should be exercised when inserting or removing
cleaning devices to avoid accidental displacement of the
prosthesis which could result in aspiration (inhalation) of the
voice prosthesis. In the unlikely event that this should occur,
you should attempt to cough the voice prosthesis out of the
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