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1.4 WARNINGS
Dislodgement or extrusion of the ProvoxVega voice prosthesis from
the TE puncture and subsequent ingestion, aspiration or tissue
damage may occur.
To reduce the risk of dislodgment/extrusion and its potential sequelae:
• Select the proper prosthesis size.
necrosis and extrusion.
• Instruct the patient to consult a physician immediately if there
• Instruct the patient to consult a physician if leakage through or
around the voice prosthesis occurs. Leakage may cause aspiration
pneumonia.
• If used, choose laryngectomy tubes or stoma buttons with a
suitable shape that do not exert pressure on the prosthesis or
and removal of the laryngectomy tube or stoma button.
• Instruct the patient to use only genuine Provox accessories of
corresponding size (Brush, Flush, Plug) for maintenance and to
avoid all other kinds of manipulation.
• Re-use and re-processing may cause cross-contamination and
damage to the device, which could cause patient harm.
1.5 PRECAUTIONS
• Carefully assess any patient with bleeding disorders or who is
undergoing anticoagulant treatment for the risk of bleeding or
hemorrhage prior to placement or replacement of the prosthesis.
• Inspect the package before use. If the package is damaged or
opened, do not use the product.
• Always use aseptic technique when handling the prosthesis in
order to reduce infection risk.
• Make sure that any external or internal stoma attachment devices
(e.g., HME base plates, laryngectomy tubes, or stoma buttons).
This may lead to severe tissue damage and/or accidental ingestion
of the prosthesis.
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 /
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
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
to the Inserter Pin (Figure 3e).
