Warnings And Precautions - inhealth Blom-Singer Instructions For Use Manual

Blom-Singer® Indwelling Voice Prostheses
biocompatible material used in many medical products.
The gel cap used for insertion of the prosthesis is made of a
vegetable base gelatin. Individual patient reactions to these
materials may occur.
The Blom-Singer voice prosthesis, (diagram 1), consists of a
one-way silicone flap valve (diagram 1a), an esophageal retention
flange (diagram 1b), a body that holds the valve assembly
(diagram 1c), a tracheal retention flange (diagram 1d), and a neck
strap (diagram 1e).

WARNINGS AND PRECAUTIONS

The Blom-Singer indwelling voice prosthesis is a medically
prescribed device. Initial sizing and instructions for use must be
provided by a qualified medical professional trained in the use of
this particular device.
The qualified, trained medical professional is to instruct patients
on the use and care of this device and to provide patients with
the Blom-Singer instructions for use supplied with the product.
If the prosthesis is not functioning properly, the patient should
have it evaluated by a qualified, trained medical professional as
soon as possible.
If there are tears, cracks, or structural damage to the prosthesis,
cleaning device or accessories, discontinue use.
Handle the device and the gel cap loading tool carefully to avoid
damaging the prosthesis.
When using a sterile voice prosthesis, aseptic handling technique
must be used. All indwelling voice prostheses must be carefully
removed from their packaging and handled in a manner to
prevent contamination of the devices.
Use only the specially sized Blom-Singer Gel Caps.
Do not use petroleum-based products such as Vaseline® to
lubricate the voice prosthesis as these products can damage the
device.
Changes in the anatomy or medical status of the patient may
lead to improper fitting and/or function of the device. It is
37640-05H | 5