Patient-Changeable Voice Prostheses; Contraindications; Product Description - inhealth BLOM-SINGER Gebrauchsanweisung

ENGLISH
BLOM-SINGER® PATIENT-CHANGEABLE
VOICE PROSTHESES
INDICATIONS
The Blom-Singer voice prosthesis is indicated for
tracheoesophageal voice restoration following total
laryngectomy.

CONTRAINDICATIONS

The Blom-Singer voice prosthesis is a medical product that
should be used only by individuals with experience and training
in its use and care.
HOW SUPPLIED
The Blom-Singer patient-changeable voice prosthesis is supplied
as a complete voice restoration system. Special order sizes/styles
are available.

PRODUCT DESCRIPTION

Please refer to the diagrams located at the back of this instruction
manual. A glossary of terms appears at the end of this IFU.
The Blom-Singer patient-changeable voice prosthesis is available
in a Low Pressure style (diagram 1A) or a Duckbill style (diagram
1B). Each prosthesis consists of a one-way valve (diagram 1A(a)
and 1B(a)), an esophageal retention flange (diagram 1A(b) and
1B(b)), a body that holds the valve assembly (diagram 1A(c) and
1B(c)), a tracheal retention flange (diagram 1A(d) and 1B(d)), and
a neck strap with safety hole (diagram 1A(e) and 1B(e)).
The Blom-Singer voice prosthesis is made of silicone, a
biocompatible material used in many medical products.
WARNINGS AND PRECAUTIONS
This product is intended for use by a single patient only.
The qualified, trained medical professional is to instruct patients
on the use and care of this device and to provide patients with
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