inhealth Blom-Singer Instructions For Use Manual page 4

BLOM-SINGER® VOICE PROSTHESIS PLACEMENT
SURGICAL KIT
Introduction
Please refer to the diagrams located at the back of this instruction
manual.
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 Blom-Singer® medical device may be used only once with
one patient. It may not be reused.
Do not use the device if it becomes contaminated; discard and
replace it with an unopened product.
INDICATIONS
The Blom-Singer® Voice Prosthesis Placement Surgical Kit is
indicated for use during surgery for primary or secondary
puncture and dilation of the tracheoesophageal wall, selection of
the proper length of voice prosthesis, and to guide the placement
of the voice prosthesis.
CONTRAINDICATIONS
Tracheoesophageal puncture and therefore also the Blom-Singer®
Voice Prosthesis Placement Surgical Kit is contraindicated:
• in patients whose medical status increases the risk of
uncontrolled dilation of the puncture and aspiration of
esophageal contents around the voice prosthesis. These
patients include those with irradiation to the tracheostoma
exceeding 6500 rads, uncontrolled diabetes mellitus,
concurrent chemotherapy and severe malnutrition;
• in the small tracheostoma of patients in which presence of the
catheter or a voice prosthesis may compromise respiration;
• in patients who cannot take care of themselves, have severe
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