inhealth Blom-Singer Instructions For Use Manual page 13

Valve Indwelling Voice Prosthesis, the inserter is designed so
that it does not fully insert into the voice prosthesis (diagram 7).
Within three minutes the inserter should visibly move forward
into the voice prosthesis; the clinician should see this forward
movement indicating that the gel cap has dissolved and that the
esophageal retention flange has deployed.
Caution: If the voice prosthesis does not insert easily on the first
attempt, do not continue to try to insert it. Instead, re-insert the
puncture dilator, of the appropriate diameter, for a few minutes
to dilate the TE tract, and then try again.
5. Detach the voice prosthesis neck strap (diagram 1e) from the
safety peg of the inserter. Place a finger against the neck strap
and carefully withdraw the inserter from the voice prosthesis
with a twisting motion. Warning: Caution should be exercised
when removing the inserter to avoid accidental displacement
of the voice prosthesis which could result in aspiration of the
voice prosthesis. Secure the voice prosthesis with medical
adhesive tape across the neck strap. It is recommended to
orient the prosthesis with the neck strap up.
6. Have the patient take a breath, occlude the stoma, and
produce voice. Ensure there is no leakage through the voice
prosthesis by having the patient drink water.
Confirmation of Esophageal Retention Flange Deployment
The following procedure for confirming deployment of the
esophageal retention flange is recommended by Eric D. Blom,
Ph.D.
After insertion of the voice prosthesis in the puncture tract and
completion of the 3-minute waiting period for gel cap dissolution
and esophageal retention flange deployment, repeatedly rotate
the prosthesis on the inserter while it is in the puncture. If the
esophageal retention flange has deployed and has properly
seated against the mucosa of the anterior esophageal wall, the
voice prosthesis on the inserter will rotate easily in the puncture
tract. If the gel cap has dissolved and incorrectly deployed the
esophageal retention flange inside the puncture tract rather than
inside the lumen of the esophagus, considerable resistance to
voice prosthesis rotation will be felt.
Blom-Singer® Indwelling Voice Prostheses
37640-05H | 13