Atos Medical PROVOX Vega XtraSeal Instrucciones De Uso página 9

2. Instructions for use
2.1 Choose size of the Voice prosthesis
Be sure to use a Provox Vega XtraSeal voice prosthesis of the proper shaft diameter and
length. Provox Vega XtraSeal is available in different length/diameter combinations.
• Selecting 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, observe and ensure that the
puncture shrinks to the appropriate diameter.
• Selecting 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.
Note: The shaft of Provox Vega XtraSeal is ca 1 mm shorter than the size indicated
due to the enlarged esophageal flange.
2.2 Preparation
(Fig. 3-6)
Position voice prosthesis
1. 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).
Fold the esophageal flange
2. Verify that the Insertion Pin is correctly positioned with the Folding Tool (The
Pin shall be snapped into the Folding Tool).
3. Squeeze the Folding Tool together with two fingers (Fig. 4).
4. Attach the Loading Tube while keeping the Folding Tool closed and twist the
Loading Tube until it locks in place (Fig. 5).
Load
5. Push the Insertion Pin forward until the voice prosthesis is aligned with the visible
ring on the Loading Tube (Fig. 6).
Remove the old voice prosthesis
6. Remove the current (old) prosthesis is from the TE-puncture by pulling it out with
a non-toothed hemostat. Alternatively, at the clinician's discretion, the tracheal
flange of the prosthesis can be grasped with forceps and cut off. The rest of the
prosthesis is then pushed into the esophagus for passage through the intestinal
tract. The patient's history of any intestinal diseases should be taken into account
before using this method.
Prepare the puncture (optional)
7. 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.
2.3 Insertion, Anterograde replacement procedure
(Fig. 7-10)
CAUTION: Provox Vega XtraSeal with enlarged esophageal flange must be placed
using the overshooting technique to ensure the additional enlarged esophageal flange
and the esophageal flange both deploy inside the esophageal lumen. Overshooting
means that the whole prosthesis is deployed in the esophagus and then retracted to
the intended position.
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. 7).
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 beyond the Proximal grip surface, (Fig. 8). At this point voice prosthesis
is fully deployed in the esophagus, (Fig.9).
If overshoot insertion is performed with the Folding Tool kept assembled, push
the Insertion Pin beyond the Distal grip surface, (Fig.10). At this point the voice
prosthesis is fully deployed in the esophagus, (Fig. 9).
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.
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