Atos Medical PROVOX Vega, Instructions For Use Manual

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4. Checking the proper fit
Check to see if the prosthesis is in the proper position by rotating
and exerting slight traction on the Tracheal Flange (Figure 3e).
The oval shape of the Tracheal Flange is helpful in determining
the ideal position of the prosthesis (by pointing downward, Figure
3g).
5. Test proper function
Test proper function of the prosthesis by asking the patient to
speak and by observing the prosthesis while the patient drinks
water (Figure 3f).
6. Cut the Safety Strap with scissors
When the prosthesis is safely in place, use scissors to cut off the
Safety Strap on the outer edge of the Tracheal Flange (Figure 3g).
The oval end of the Tracheal Flange should point downwards
into the trachea. The Provox Vega voice prosthesis is now ready
for use.
2.3 Anterograde replacement procedure
using voluntary overshooting
(Figures 4a-h)
When the puncture tract is very short, or when mucosa folds over
the posterior part of the prosthesis, or when the esophageal flange
is difficult to develop within the esophagus, overshooting can help
to completely develop the esophageal flange of the prosthesis.
Overshooting means that during the insertion procedure, the Provox
Vega voice prosthesis is pushed entirely through the puncture into
the esophagus. The prosthesis Safety Strap remains thereby attached
to the Inserter Pin.
Activating System for replacement using
voluntary overshooting
1. With one hand holding the loading tube, use the other hand to
push the inserter pin partially into the loading tube, until the
blue ring of the prosthesis has passed the step marker of the
loading tube (Figure 4a).
2. Squeeze the Guide between thumb and index finger (Figure 4b).
Push it further into the loading tube (Figure 4c). The Provox
Vega voice prosthesis is now ready for overshoot-insertion.
Inserting the new prosthesis into the puncture -
Overshoot
1. Probing the TE-puncture
Hold the Provox SmartInserter by the Loading Tube. Gently
insert the Tip of the Loading Tube. Proceed with care if you
encounter resistance during insertion of the Loading Tube into
the puncture (Figure 3b). In this case, dilatation and/or lubrication
of the puncture can ease the insertion
2. “Injecting” the prosthesis
With one hand holding the loading tube stable in this position, use
the other hand to advance the Inserter Pin until it is completely
inserted into the SmartInserter (Figure 4d).
As the Guide is being pushed further into the Loading Tube, the
Inserter Pin will advance further and release the Provox Vega
voice prosthesis completely within the esophagus.
3. Pulling the prosthesis back
Pull the Loading Tube out from the puncture (Figure 4e). Pull
the Provox Vega voice prosthesis back into the puncture by
grasping and pulling the tracheal flange of the prosthesis with
a non-toothed hemostat (Figure 4f).
4. Checking the proper fit
Check to see if the prosthesis is in the proper position by rotating
and applying slight traction on the tracheal flange (Figure 4g). The
oval shape of the tracheal flange should be pointed downwards
(Figure 4g).
5. Test proper function
Test proper function of the prosthesis by asking the patient to
speak and by observing the prosthesis while the patient drinks
water (Figure 3f).
6. Cut the Safety Strap with scissors
When the prosthesis is safely in place, use scissors to cut
off the Safety Strap on the outer edge of the tracheal flange
(Figure 3g). The oval end of the tracheal flange should point
downwards into the trachea (Figure 3f). The Provox Vega voice
prosthesis is now ready for use.
CAUTION: If reloading the SmartInserter after Overshooting,
make sure the Folding device and Guide are assembled in proper
way (see section 2.4 below).
2.4 Reloading the Provox SmartInserter
(Figures 5a-i)
If the first attempt to insert the Provox Vega voice prosthesis into the
TE-puncture was unsuccessful, it is possible to reload the Provox
Vega into the SmartInserter.
CAUTION: Do not reload the SmartInserter more than 2 times.
If the Provox Vega voice prosthesis shows any signs of damage, do
not use the prosthesis and obtain a replacement prosthesis.
1. Make sure the prosthesis is still safely attached to the Inserter Pin
(Figure 5b1-5b2). If not, secure the Safety Strap on the Inserter
Pin by leading the Safety Strap through the Attachment Hole
in the Inserter Pin (Figure 5c-d).
2. Put the Provox Vega voice prosthesis with the tracheal side
down on top of the Inserter Pin (Figure 5e-f). Use your thumb
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