PROVOX Vega Manual De Instrucciones página 11

2.2 Operating instruction
Check the integrity of the sterile package. Do not use the product if the package is damaged or opened.
Unsterile product may cause infection.
2.2.1 Primary puncture and prosthesis placement
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1. After removal of the larynx and creation of the tracheostoma, before closure of the pharynx,
insert the Pharynx Protector in the open pharynx/esophagus (Fig. 2.1).
2. Verify the correct location for the TE puncture by palpating the inside of the trachea at the desired
puncture site. The oblique front opening of the Pharynx Protector (or the slit on the upper side,
depending on surgical technique) should be felt during palpation (Fig. 2.2).
3. Insert the Puncture Needle at the correct puncture site (about 8-10 mm from the edge of the
tracheostoma) until the tip of the needle reaches the inner lumen of the Pharynx Protector
(Fig. 2.3).
If an endotracheal tube is in situ, this tube should be removed if it obstructs proper dilatation
and integral placement of the voice prosthesis.
4. Insert the Guidewire into the hub of the Puncture Needle. Push the Guidewire through the
needle until it extends approx. 20 cm out from the lumen of the Pharynx Protector (Fig. 2.4).
WARNING: Always verify that the Guidewire comes out through the lumen of the Pharynx
Protector. Otherwise there is a risk for (sub) mucosal damage and the procedure needs to be
restarted (see Adverse Events and Troubleshooting Information as well as Instructions for Reload
of the Puncture Set).
5. Remove the Puncture Needle (Fig. 2.5).
CAUTION: Always remove the needle before removing the Pharynx Protector. There is a risk
for damaging the esophageal tissue otherwise.
6. Remove the Pharynx Protector. Only the Guidewire should remain in situ before continuing
(Fig. 2.6).
7. Insert the Guidewire extending from the esophageal side into the narrow end of the Puncture
Dilator and push the Guidewire through the Puncture Dilator until it extends approx. 10 cm
through the Puncture Dilator exit hole (Fig. 2.7).
8. Grab the tip of the Guidewire and insert it in the hole next to the exit hole (Fig. 2.8).
9. Tighten the Guidewire by pulling it from the narrow end of the Puncture Dilator and verify that
it is secured to the Puncture Dilator (Fig. 2.9).
10. Using a continuous, smooth motion; dilate the puncture site by carefully pulling the Guidewire
through the puncture. During dilatation, support the TE tissue (for example with two fingers)
to reduce dilatation force. For better control, firmly grasp the Guidewire close to the Puncture
Dilator (Fig. 2.10).
CAUTION: Dilatation and integral placement of the voice prosthesis should be carried out in
the anterior/caudal direction with limited lateral movement in order to limit the force applied to
the TE wall.
11. In the same continuous, smooth motion, carefully pull the Guidewire, Puncture Dilator and the
Puncture Dilator loop through the puncture. The Puncture Dilator loop folds the tracheal flange
of the voice prosthesis as the loop is pulled over the flange and through the puncture. The tracheal
flange unfolds in the trachea when the loop releases it (Fig. 2.11).
Stop pulling immediately when the tracheal flange is released by the Puncture Dilator loop.
If the tracheal flange does not unfold completely, it can be rotated in place using two non-toothed
hemostats.
12. Grasp the tracheal flange of the voice prosthesis with a non-toothed hemostat, turn the prosthesis
in the correct position, and cut the safety strap (Fig. 2.12).
2.2.2 Secondary puncture and prosthesis placement
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The Pharynx Protector (Fig. 1.1) included in the Provox Vega Puncture Set is not used during
secondary puncture.
1. Choose an instrument (e.g., a rigid endoscope) which can function as;
a. a protector when the needle is penetrating the TE wall and
b. a guide for the correct location of the TE puncture and
c. a means to facilitate a safe passage of the Guidewire when it is passed through the pharynx
and out of the mouth.
Introduce the instrument into the esophagus (Fig. 3.1). If an endotracheal tube is in situ, this tube
should be removed if it obstructs proper dilatation and integral placement of the voice prosthesis.
CAUTION: Always make sure that the instrument selected for pharynx protection does contains
a lumen for safe passage of the Guidewire. Otherwise, there is risk for (sub) mucosal damage.
2. Verify the correct location of the instrument by palpating the trachea at the intended puncture
site. For additional visual and/or transilluminated guidance, a flexible endoscope could be used
(Fig. 3.2).
3. Insert the Puncture Needle at the correct puncture site (about 8-10 mm from the edge of the
tracheostoma) until the tip of the needle reaches the inside wall of the instrument (Fig. 3.3).
4. Insert the Guidewire into the hub of the Puncture Needle. Push the Guidewire into the needle,
up through the lumen of instrument until it extends approx. 20 cm out through the distal end of
the instrument (Fig. 3.4).
WARNING: Always verify that the Guidewire comes out through the lumen of the instrument
chosen for pharynx protection. Otherwise there is a risk for (sub) mucosal damage and the
procedure needs to be restarted (see Adverse Events and Troubleshooting Information as well
as Instructions for Reload of the Puncture Set).
5. Remove the Puncture Needle (Fig. 3.5).
CAUTION: Always remove the needle before removing the instrument. There is a risk for
damaging the esophageal tissue otherwise.
6. Remove the instrument used for pharynx protection. Only the Guidewire should remain in situ
before continuing (Fig. 3.6).
7. From the cranial side, insert the Guidewire into the narrow end of the Puncture Dilator and push
the Guidewire until it extends approx. 10 cm through the Puncture Dilator exit hole (Fig. 3.7).
8. Grab the tip of the Guidewire and insert it in the hole next to the exit hole of the Puncture Dilator
(Fig. 3.8).
9. Tighten the Guidewire by pulling it from the narrow end of the Puncture Dilator and verify that
it is secured to the Puncture Dilator (Fig. 3.9).
CAUTION: Ensure that the Guidewire is tightly secured in the Wirelock of the Puncture
Dilator. If the Guidewire is not securely locked into the Wirelock, the Guidewire could separate
from the Puncture Dilator and the Puncture Dilator may end up in the esophagus requiring
retrieval using additional instruments (e.g., laryngeal forceps).
10. Using a continuous, smooth motion; dilate the puncture site by carefully pulling the Guidewire
through the puncture site until the thick end of the Puncture Dilator has passed the puncture.
During dilatation, support the TE tissue (for example with two fingers) to reduce dilatation force.
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