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inhealth Blom-Singer Instructions For Use Manual page 6

Indwelling voice prostheses for primary, secondary, replacement tep procedures
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recommended that the voice prosthesis and TEP be evaluated by
the clinician at regular intervals.
Voice Production
To prevent post-operative complications, the patient should not
begin speaking with the voice prosthesis until the clinician has
indicated that it is safe to do so.
The lumen of the voice prosthesis must be kept clear of blockage
in order for it to function properly to allow the patient to voice.
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 professional assessment.
Patients requiring postoperative radiation may have transient
interruption of voice in the third or fourth week of treatment. The
prosthesis can be left in place or a catheter can be inserted as a
stent until radiation treatments are completed.
Voice Prosthesis Dislodgement
Care must be exercised during voice prosthesis insertion or
removal to avoid injury to the TEP or accidental displacement of
the voice prosthesis which could result in aspiration of the voice
prosthesis into the trachea. Should aspiration occur, the patient
should attempt to cough the voice prosthesis out of the trachea.
Further medical attention may be necessary if coughing the voice
prosthesis out is unsuccessful.
Confirm gel cap dissolution and deployment of the esophageal
retention flange per procedures provided below to ensure device
is securely retained in TEP.
If the voice prosthesis is accidentally dislodged from the puncture,
the patient should immediately place a Blom-Singer Puncture
Dilator or suitable device, of the appropriate diameter, in the
puncture to keep it from closing and leaking fluids. The voice
prosthesis should be reinserted within 24 hours.
Foreign objects, other than the supplied cleaning devices, should
never be inserted into the voice prosthesis by the patient.
Inserting objects other than the supplied cleaning devices may
cause dislodgment of the voice prosthesis or its components and
may cause these objects to be swallowed or aspirated.
6 | 37640-05H

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