inhealth Blom-Singer Instrucciones De Uso página 8

Many clinicians recommend routine follow-up evaluations not
longer than 6 months from initial placement.
Removal of the indwelling voice prosthesis should only be done
by grasping the outer tracheal flange of the device securely with
a locking hemostat. Pull gently and firmly until the prosthesis is
fully withdrawn.
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; intractable
leakage around the voice prosthesis, requiring surgical revision
or closure of the puncture; dysphagia, 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.
INSTRUCTIONS FOR USE
The following instructions are provided for primary and secondary/
replacement procedures.
Always measure the TE puncture tract before inserting a voice
prosthesis to confirm correct voice prosthesis length.
Primary Voice Prosthesis Placement
The following procedure is provided by the late Ronald C. Hamaker,
M.D., F.A.C.S., as recommended instructions for primary placement of
the voice prosthesis at the time of the tracheoesophageal puncture
during laryngectomy.
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