Instructions For Use; Preparation; Anterograde Replacement Procedure - Atos Medical PROVOX Vega Bedienungsanleitung

2. Instructions for use

2.1 Preparation

Choosing the right shaft diameter and length of the replacement
prosthesis
Be sure to use a Provox Vega voice prosthesis of the proper shaft diameter
and length. Provox Vega is available in different shaft diameters and
in several lengths.
• Shaft diameter
The Clinician should determine the proper diameter of the prosthesis
appropriate for the patient.
• If the selected diameter is larger than the previous prosthesis the
tract must be dilated using the Provox Dilator appropriate to the
diameter of the prosthesis being inserted.
• If a prosthesis with a smaller shaft diameter is inserted, it is
important to observe and ensure that the puncture shrinks to the
appropriate diameter.
• Shaft length
To select the correct length, you may use the current prosthesis as
its own measuring device. If there is too much (i.e. 3 mm / ~0.12
inches, or more) space between the Tracheal Flange of the old
prosthesis and the mucosal wall, a shorter prosthesis should be
used. If the prosthesis sits too tight, a longer prosthesis should be
used.

2.2 Anterograde replacement procedure

(Figures 3a-g)
Activating Provox SmartInserter for replacement
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 3a).
The Provox Vega voice prosthesis is now ready for insertion.
Preparing the puncture (optional)
The puncture may be dilated to prepare for the insertion of the voice
prosthesis. This is usually not necessary but may facilitate insertion
in patients with angled or tight punctures that easily collapse.
Inserting the new prosthesis into the puncture
The current (old) prosthesis is removed from the TE-puncture by
pulling out the device with a non-toothed hemostat.
1. Probing the TE-puncture
Hold the Provox SmartInserter by the Loading Tube. Gently insert
the Tip of the Loading Tube (Figure 3b). Proceed with care if you
encounter resistance during insertion of the Loading Tube into
the puncture. In this case, dilatation and/or lubrication can ease
the insertion.
2. "Injecting" the prosthesis
With one hand holding the loading tube stable in this position, use
the thumb of the other hand to advance the Inserter Pin until it is
completely inserted into the SmartInserter (Figure 3c).
3. Releasing the prosthesis
Pull the SmartInserter straight out from the puncture (Figure 3d).
The prosthesis remains in the puncture; still firmly attached to the
Inserter Pin (Figure 3e).
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.
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