inhealth technologies Blom-Singer Instrucciones De Uso página 9

4. Insert the folded portion of the esophageal flange into the gel cap (diagram 6). Gently tuck and
push the folded esophageal flange as far as possible into the gel cap.
5. Use the curved side of the flange introducer and following the curve of the device body,
gently tuck the remaining portion of the folded esophageal flange completely into the gel cap
(diagram 7). Do not use any sharp or serrated instruments to avoid damaging the prosthesis or
gel cap.
6. The esophageal flange should be folded in a forward position and completely enclosed inside
the gel cap (diagram 8).
Device Insertion
1. Place the device on the inserter and lock the safety strap onto the safety peg (diagram 9).
2. Caution the patient not to swallow as you remove the dilator or sizer to avoid aspiration of saliva
into the trachea prior to inserting the voice prosthesis.
3. Apply a light coating of water-soluble lubricant (not petroleum based) to the tip of the gel-
capped end of the device and place the tip of the voice prosthesis in the TEP with the safety
strap oriented upwards. Insert the device completely into the TEP until the tracheal flange of the
device is seated firmly against the posterior tracheal mucosa.
4. Hold the device in this position of complete insertion for at least three minutes to allow the gel
cap to dissolve and release the esophageal flange within the esophagus. Patients should be
instructed to swallow their saliva to facilitate dissolving the gel cap.
5. Confirm the esophageal flange has deployed: Rotate the device on the inserter while it is in the
TEP. The device will rotate easily on the inserter in the TEP if the esophageal flange has deployed
and is seated against the anterior esophageal wall. Considerable resistance to device rotation
will be felt if the gel cap has not dissolved or incorrectly deployed in the TEP instead of inside
the lumen of the esophagus.
6. Detach the safety strap from the safety peg of the inserter. Place a finger against the safety strap
and carefully withdraw the inserter from the device with a twisting motion. Secure the safety
strap of the device to the neck with medical adhesive tape across the safety strap.
Warning: Caution should be exercised when removing the inserter to avoid accidental
displacement of the voice prosthesis, which could result in aspiration of the device.
7. Assess the capacity to produce tracheoesophageal voice. Digital occlusion of the tracheostoma
will divert airflow from the trachea. A device that is correctly positioned with the gel cap fully
dissolved should allow that airflow to open the flap valve and pass into the esophagus for
tracheoesophageal voice production (diagram 10).
8. Ensure there is no leakage through or around the device by having the patient drink water
(diagram 11).
Confirmation of Valve Function and Esophageal Flange Deployment (Non-Dual Valve)
If the proper deployment and positioning of the esophageal flange cannot be confirmed
by methods described above, the clinician may need to determine gel cap dissolution and
esophageal retention flange deployment by manually opening, with gentle contact, the one-
way flap valve in the esophageal end of the voice prosthesis. Direct a bright light into the
prosthesis to visualize the flap valve at the proximal end. Slowly and carefully advance the
blunt end (non-cotton tip) of a cotton-tipped applicator into the voice prosthesis until gentle
contact opens the flap valve. A flap valve that does not open with gentle contact may indicate
an undeployed flange or inverted flap valve is impairing valve function. If indicated, direct
visualization of esophageal flange deployment can be obtained with flexible endoscopy. If
the assessment methods described above fail to provide satisfactory verification of correct
esophageal retention flange deployment, remove the device, dilate and re-measure the
puncture tract, and repeat the device insertion and confirmation process.
Confirmation of Valve Function and Esophageal Flange Deployment (Dual Valve)
To accommodate esophageal flange deployment of the Dual Valve Indwelling Voice Prosthesis,
the inserter is designed so that it does not fully insert into the voice prosthesis. Within three
Blom-Singer Indwelling Voice Prostheses
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