inhealth technologies Blom-Singer Instrucciones De Uso página 7

Blom-Singer Indwelling Voice Prostheses
®
prosthesis, the standard practice is to use a voice prosthesis with an enlarged esophageal or
enlarged esophageal and tracheal flanges; use of a voice prosthesis with enlarged flanges
may help reduce the risk of peripheral leakage/aspiration and voice prosthesis dislodgement.
Individual patient reactions to the device materials may occur. Consult a clinician immediately if
there are indications of tissue edema (swelling) and/or inflammation/infection. Evaluate patients
with bleeding disorders or if they are undergoing anticoagulant (blood thinning) treatment for
the risk of hemorrhage (bleeding) prior to placement or replacement of the device.
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 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 an inability
to speak fluently and with minimal effort. This problem requires professional assessment.
Patients requiring post-operative radiation may have transient interruption of voice in the third
or fourth week of treatment. The device can remain in place as determined by the clinician.
Voice Prosthesis Dislodgement
Care must be exercised during device insertion, removal, or use of cleaning devices to avoid
injury to the TEP or accidental displacement of the device, which could result in aspiration
(inhalation) of the device into the trachea (windpipe). Should aspiration occur, the patient
should attempt to cough the device out of the trachea. Further medical attention may
be necessary if coughing the device out is unsuccessful. Confirm gel cap dissolution and
deployment of the esophageal flange to ensure device is securely retained in TEP. If the voice
prosthesis is dislodged from the TEP, a Blom-Singer Puncture Dilator or suitable device of the
appropriate diameter should be immediately placed in the puncture to keep it from closing and
leaking fluids. A replacement device should be inserted within 24 hours. Foreign objects should
not be inserted into the device. Inserting objects other than the Blom-Singer cleaning devices
may cause dislodgment and subsequent aspiration or ingestion of the voice prosthesis or its
components.
Voice Prosthesis Leakage
When the flap valve fails to close completely, a few drops of fluid may pass through the device
from the esophagus (food pipe) to the trachea, which may cause coughing or aspiration. Use
of a smaller diameter voice prosthesis than the existing tracheoesophageal puncture size
may result in peripheral leakage (leakage around the device). Recurrent leakage of the voice
prosthesis should be evaluated by a clinician as leakage could cause aspiration pneumonia.
Selection of a different device model/option may be indicated. Gentle handling and pressure
should always be used when cleaning the voice prosthesis to avoid device damage, which could
cause leakage.
Microbial (Microscopic Organisms) Growth
Microbial growth deposits on the device may cause valve deformation and failure, i.e., fluid
leakage through or around the device and/or an increase in the pressure necessary to voice.
Replacement of the device may be required.
Device Insertion/Removal
The attached safety strap on an indwelling voice prosthesis should only be removed after the
esophageal flange has been verified to have deployed in the esophagus. Never attempt to
insert or reinsert an indwelling voice prosthesis that has the safety strap removed.
Never remove one indwelling voice prosthesis and insert another without first dilating the TEP
and re-measuring the tract to confirm correct voice prosthesis length. The patient should never
attempt to insert or remove the device or allow anyone other than a qualified clinician to insert
or remove the device. The indwelling voice prosthesis is not a permanent device and requires
replacement periodically.
37924-01B I 7