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Blom-Singer ® Patient-changeable Voice Prostheses
the Blom-Singer instructions for use supplied with the product.
Should the voice prosthesis 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 voice
prosthesis, discontinue use.
Handle the voice prosthesis, cleaning device and the gel cap
loading tool carefully to avoid damaging the prosthesis.
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.
Initial sizing of the voice prosthesis must be provided by a
qualified medical professional trained in the use of this particular
device.
In some users the inability to relax the muscles of the throat may
account for their inability to speak fluently and, to speak with
minimal effort. This problem requires assessment.
Users with a voice prosthesis who undergo postoperative
radiation may experience transient interruption of voice in the
third or fourth week of treatment. The prosthesis can be left in
place throughout radiation treatments.
When using the Blom-Singer gel caps for insertion, always wait at
least two minutes following insertion of the Low Pressure voice
prosthesis into the TE puncture before detaching the strap from
the safety peg and withdrawing the inserter.
The tip of the Low Pressure Voice Prosthesis, the gel cap loading
tool, the gel cap, the pushrod, and the user's hands must be
completely dry prior to using the Gel Cap Insertion System in
order to prevent premature dissolution of the gel cap.
The Blom-Singer Gel Cap Insertion System is designed for use
with Blom-Singer Low Pressure voice prostheses only. Do not use
this product with any other type of devices.
Voice Production
To prevent post-operative complications, do not begin speaking
with the voice prosthesis until your doctor has informed you that
37531-01I | 5

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