Product Description - inhealth Blom-Singer Instructions For Use Manual

BLOM-SINGER® INDWELLING VOICE PROSTHESES
for Primary, Secondary, Replacement TEP Procedures
This Blom-Singer medical device may be used only once by
one patient. It may not be reused. See Warnings, Precautions
and Complications.
Do not use the device if it becomes contaminated; discard and
replace it with a newly packaged prosthesis.
INDICATIONS
The Blom-Singer Indwelling Voice Prosthesis is indicated
for tracheoesophageal voice restoration following total
laryngectomy, when placement, or replacement, of an indwelling
voice prosthesis is performed by a qualified, trained medical
professional.
CONTRAINDICATIONS
The Blom-Singer indwelling voice prosthesis is a medical product
that should be used only by a qualified, medical professional with
experience and training in its use and care.
HOW SUPPLIED
The Blom-Singer Indwelling Voice Prosthesis is supplied in sterile
or non-sterile options, as a complete voice restoration system
for primary, secondary, or replacement procedures. Sterile voice
prostheses are sterilized by ethylene oxide. Included in each
package is a Voice Prosthesis Cleaning System for the patient, two
(2) gel caps, flange introducer and inserter.

PRODUCT DESCRIPTION

Please refer to the diagrams located at the back of this instruction
manual.
Nonsterile product is not intended for primary placement
procedures.
The Blom-Singer voice prosthesis is made of silicone, a
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