Atos Medical PROVOX Vega Mode D'emploi page 10

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.
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).
(N/A for Capsule Insertion)
Load
5. Push the Insertion Pin forward until the voice prosthesis is aligned with the visible
ring on the Loading Tube (Fig. 6). (N/A for Capsule Insertion)
Remove the old voice prosthesis
6. Remove the current (old) prosthesis 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
Four methods can be used to insert a Provox Vega voice prosthesis with the Provox
Insertion System. The choice of method is at the clinician´s discretion.
2.3.1 System Insertion: The entire insertion system is used.
2.3.2 Tube Insertion: The folding Tool is removed before insertion.
2.3.3 Overshoot Insertion: The entire voice prosthesis is deployed in the esophagus
and then retracted to the intended position.
2.3.4 Capsule Insertion: The voice prosthesis is placed into a Provox Capsule before
insertion.
2.3.1 Method 1: System Insertion
1. 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.
2. Insert the voice prosthesis
Hold the Loading Tube stable with one hand and push the Insertion Pin with the
other hand until the arrows at the Distal grip surface are flush with the bottom
edge of the Folding Tool (Fig. 7). At this point, the esophageal flange of the voice
prosthesis is entirely unfolded in the esophagus.
3. Release the voice prosthesis
Pull the Loading Tube and Folding Tool together straight out from the puncture.
The voice prosthesis remains in the puncture; still firmly attached to the
Insertion Pin.
4. Finalize the procedure
After insertion, finalize the procedure as described below in section 2.5.
2.3.2 Method 2: Tube Insertion
To enhance visibility, the Folding Tool can be removed once the prosthesis has been
pushed into the Loading Tube.
Note: It is important to always use the Provox Insertion System with Folding Tool
attached when loading the prosthesis to ensure proper folding of the esophageal flange.
1. Remove the Folding Tool
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
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