inhealth Blom-Singer Instructions For Use Manual page 5

Blom-Singer ® Voice Prosthesis Placement Surgical Kit
arthritis or blindness, or are not interested in speaking.
Do not use the Blom-Singer® Voice Prosthesis Placement Surgical
Kit if the patient's health status or anatomical abnormalities
contraindicate performing a tracheoesophageal puncture or
insertion of a voice prosthesis.
Patients with known bleeding disorders or those on anticoagulants
should be assessed prior to tracheoesophageal puncture to avoid
bleeding or hemorrhage complications.
HOW SUPPLIED
The Blom-Singer® Voice Prosthesis Placement Surgical Kit is
provided sterile (by gamma radiation) in a tray within a pouch
and ready to be introduced into the surgical field. Do not
resterilize.
PRODUCT DESCRIPTION
The Blom-Singer® Voice Prosthesis Placement Surgical
Kit is designed to be used during surgery for primary or
secondary placement of a tracheoesophageal puncture and
voice prosthesis. This set includes one of each: (1) Trocar, a
13 gauge curved needle fitted with a 9 gauge sheath (stent);
(2) Catheter, a 16 Fr or 20 Fr, 33 inch catheter with taper; (3)
Pharynx Protector, a tool with handle and notched cylinder.
NOTE: Blom-Singer® Voice Prosthesis Placement Surgical Kit is
designed to be used with Blom-Singer® Classic™ Indwelling Voice
Prosthesis - Sterile Series. Indwelling voice prosthesis and inserter
stick packaged separately.
WARNINGS AND PRECAUTIONS
Use of this product is for trained physicians only.
A primary tracheoesophageal puncture procedure is only
recommended with use of the included pharynx protector to
provide protection of the posterior esophagus. The physician
must puncture into the pharynx protector to prevent puncturing
the posterior esophagus which could result in dysphagia,
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