How Supplied; Product Description; Warnings And Precautions - inhealth Blom-Singer Gebrauchsanweisung

Blom-Singer ® Plug Insert

HOW SUPPLIED

The Blom-Singer Plug Insert is supplied non-sterile as an accessory
device for use with a Blom-Singer indwelling voice prosthesis. An
inserter tool is included with each device.

PRODUCT DESCRIPTION

The Blom-Singer Plug Insert is made of silicone, a biocompatible
material used in many medical products. It is available in two
models (16 Fr. and 20 Fr.) for use with the Blom-Singer Classic and
Advantage Indwelling Voice Prostheses.
The Plug Insert (diagram 1) is designed to prevent leakage
through the voice prosthesis until such time that the voice
prosthesis and TEP is evaluated by a clinician; it does not allow
voicing. The Plug Insert consists of a plug tip (diagram 1a) and
neck strap with safety hole (diagram 1b). The Plug Insert may be
inserted by the user.

WARNINGS AND PRECAUTIONS

The qualified, trained medical professional is to instruct patients
on the use and care of this device and to provide patients with
the instructions for use supplied with the product.
Should the device show signs of malfunction, contact your
physician/clinician as soon as possible to have the device
performance evaluated.
If there are tears, cracks, or structural damage to the device,
discontinue use.
Changes in your anatomy or medical status may lead to improper
fitting and/or function of the device. It is recommended that your
voice prosthesis and TEP be evaluated by your clinician at regular
intervals.
This device is designed for temporary use only (maximum of
30 days) and is not intended to replace the indwelling voice
prosthesis. After placement of the device, contact your physician/
clinician as soon as possible.
Do not detach or in any way modify the neck strap on the Plug
Insert.
Do not use solvents or petroleum-based products for cleaning or
lubricating the device. These materials may damage silicone or
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