Atos Medical PROVOX Vega Mode D'emploi page 11

the Loading Tube Tip. Proceed with care if you encounter resistance. If there is
resistance, dilatation and/or lubrication can ease the insertion.
3. Insert the voice prosthesis
Push the Insertion Pin with the other hand until the arrows at the Proximal grip
surface are flush with the Loading Tube (Fig. 9). At this point, the esophageal
flange of the voice prosthesis is entirely unfolded in the esophagus.
4. Release the voice prosthesis
Hold the Loading Tube with one hand and the Insertion Pin with the other hand.
Pull both the Loading Tube and the Insertion Pin back until you feel the esophageal
flange has reached the anterior esophageal wall. Then, let go of the Insertion Pin
and pull the Loading Tube straight out from the puncture. This will release the
tracheal flange.
Note: If the tracheal flange unfolds inside the esophagus or puncture (unintentional
overshooting), grasp the tracheal flange with a non-toothed hemostat and pull/
rotate the voice prosthesis into place.
5. Finalize the procedure
After insertion, finalize the procedure as described below in section 2.5
2.3.3 Method 3: Overshoot Insertion
Overshooting of the Provox Vega voice prosthesis is occasionally performed to ensure
complete development of the esophageal flange in difficult TE punctures.
1. Remove the Folding Tool (Optional)
After the prosthesis has been pushed into the Loading Tube, remove the Folding
Tool by unlocking and disconnecting it from the Loading Tube (Fig. 8).
2. Enter the TE-puncture
Hold the Provox Insertion System by the Loading Tube. Enter the puncture with
the Loading Tube Tip. Proceed with care if you encounter resistance. If there is
resistance, dilatation and/or lubrication can ease the insertion.
3. Insert the voice prosthesis
Hold the Loading Tube stable with one hand and push the Insertion Pin with the
other hand until beyond the Proximal grip surface (Fig. 10). At this point the voice
prosthesis is fully deployed in the esophagus (Fig.11).
If overshoot insertion is performed with the Folding Tool kept assembled, push
the Insertion Pin beyond the Distal grip surface. At this point the voice prosthesis
is fully deployed in the esophagus (Fig. 12).
4. Release the voice prosthesis
Pull the Loading Tube straight out from the puncture. The prosthesis remains in
the esophagus; still firmly attached to the Insertion Pin. Grasp the tracheal flange
with a non-toothed hemostat and pull/rotate the voice prosthesis into place.
5. Finalize the procedure
After insertion, finalize the procedure as described below in section 2.5
2.3.4 Method 4: Capsule Insertion
The Folding Tool of Provox Insertion System can be used for folding the esophageal
flange of a standard Provox Vega voice prosthesis into a Provox Capsule*. In this
procedure the Loading Tube is not used.
Note: This procedure only describes the process of loading the Provox Vega into the
Provox Capsule. For information about insertion into the TE-Puncture, please see the
Instructions for Use accompanying the Provox Capsules.
1. Insert the prosthesis into Provox Capsule
Squeeze the Folding Tool together with two fingers and place the capsule in the
opening of the Folding Tool (Fig. 13). Keep the Folding Tool together, while
holding the capsule down with the index finger (Fig. 14). Push the Insertion Pin
firmly forward; this will load the esophageal flange of the voice prosthesis into
the capsule.
2. Check proper loading
The voice prosthesis is now loaded into Provox Capsule, and the Folding Tool can
be removed from the Insertion Pin. Confirm that the esophageal flange is inside the
capsule (Fig. 15). If the voice prosthesis is not properly folded, the loading process
should be repeated with a new Provox Capsule.
3. Remove the voice prosthesis and prepare the TE puncture (see Section 2.2 points
6 and 7) and place the voice prosthesis in accordance with the Instruction for Use
for the Provox Capsule.
* Not available in all countries.
2.4 Assembly and reloading the Provox Insertion
System
If the first attempt to insert the Provox Vega into the TE-puncture was unsuccessful, it
is possible to reload the voice prosthesis into the Provox Insertion System.
Position voice prosthesis
1. Mount the voice prosthesis with the tracheal side facing down on top of the Insertion
Pin.
2. Attach the Safety Strap by leading it through the Attachment Slot from either side.
3. Ensure the Voice Prosthesis is properly positioned on the Insertion Pin, firmly
attached and with the tip of the pin positioned all the way into the blue ring of the
voice prosthesis (Fig. 3).
Connect the Folding Tool
4. Guide the Insertion Pin through the opening in the Folding Tool until it clicks
in place. Pull the pin until the pin is snapped into the Folding Tool (Fig. 16). The
Provox Insertion System is now ready for preparation. Continue the preparation
as described above in section 2.2.
CAUTION: Do not reload more than twice. If the Provox Vega voice prosthesis shows
any signs of damage, do not use the voice prosthesis.
11