Instructions For Use; Preparation; Anterograde Replacement Procedure Using Overshooting; Reloading The Provox Smartinserter - Atos Medical Provox Vega XtraSeal Manual Del Usuario

2. Instructions for use

2.1 Preparation

Choosing the right size of the replacement 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 fl ange.

2.2 Anterograde replacement procedure using overshooting

(Fig. 3.1 – 3.10)
CAUTION: Provox Vega XtraSeal with enlarged esophageal fl ange must be placed using
the overshooting technique to ensure the additional enlarged esophageal fl ange and the
esophageal fl ange both deploy inside the esophageal lumen. Overshooting means that the
whole prosthesis is deployed in the esophagus and then retracted to the intended position.
Activating System for replacement using 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 (Fig. 3.1).
2. Squeeze the Guide between thumb and index fi nger (Fig. 3.2). Push it further into
the loading tube (Fig. 3.3 ). The Provox Vega XtraSeal 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. In this case, dilatation and/or lubrication of the
puncture can ease the insertion
2. "Injecting" the prosthesis
Hold the loading tube stable in this position and use the other hand to advance the
Inserter Pin until completely inserted into the SmartInserter (Fig. 3.4). As the Guide is
being pushed further into the Loading Tube, the Inserter Pin will advance further and
release the Provox Vega XtraSeal voice prosthesis completely within the esophagus.
3. Pulling the prosthesis back
Pull the Loading Tube out from the puncture (Fig. 3.5). Pull the Provox Vega XtraSeal
voice prosthesis back into the puncture by grasping and pulling the tracheal fl ange
of the prosthesis with a non-toothed hemostat (Fig. 3.6).
4. Checking the proper fi t
Check to see if the prosthesis and the fl anges are in the proper position by rotating
and moving the prosthesis back and forth in the puncture. Apply slight traction on
the tracheal fl ange to ensure proper retention of the voice prosthesis (Fig 3.7).
Caution: Confi rm that both esophageal fl anges have deployed entirely in the lumen of
the esophagus. No part of the enlarged esophageal fl ange should be visible alongside
the shaft of the voice prosthesis and when rotated the voice prosthesis should move
freely. Rotating the voice prosthesis while at the same time slightly pushing it towards
the esophagus can help to unfold the enlarged fl ange completely. In case of uncertainty,
use fl exible endoscopy to confi rm proper placement inside the esophagus.
5. Test proper function
Test proper function of the prosthesis by asking the patient to speak (Fig. 3.8) and
by observing the prosthesis while the patient drinks water (Fig. 3.9).
6. Cut the Safety Strap with scissors
When the prosthesis is confi rmed to be in place, position the oval end of the tracheal
fl ange pointing downwards and use a pair of scissors to cut off the Safety Strap on
the outer edge of the fl ange (Fig. 3.10). The voice prosthesis is now ready for use.

2.3 Reloading the Provox SmartInserter

(Fig. 4.1 – 4.6)
If the fi rst attempt to insert the Provox Vega XtraSeal voice prosthesis into the TE-puncture
was unsuccessful, it is possible to reload the Provox Vega XtraSeal into the SmartInserter.
CAUTION: Do not reload the SmartInserter more than 2 times.
If the Provox Vega XtraSeal voice prosthesis shows any signs of damage, do not use the prosthesis.
1. Make sure the prosthesis is still safely attached to the Inserter Pin. If not, secure the
Safety Strap on the Inserter Pin by leading the Safety Strap through the Attachment
Hole in the Inserter Pin (Fig. 4.1).
2. Put the Provox Vega XtraSeal voice prosthesis with the tracheal side down on top
of the Inserter Pin (Fig. 4.2). Use your thumb to ensure that the voice prosthesis is
properly positioned.
3. Check that the Folding Device and Guide are still assembled in the upper Guide
position. If not, re-assemble the Folding Device into Guide (Fig. 4.3). Do not push
the Folding Device in the bottom position of the Guide.
4. Gently pull the Inserter Pin with the attached prosthesis into the Folding Device
until you can clearly hear it click in place (Fig. 4.4). The Esophageal Flange of the
prosthesis is now in level with the Folding Device.
5. The enlarged E-fl ange must be manually positioned below the curved tips of the
folding device (Fig. 4.5).
NOTE: If this step is omitted, preloading the voice prosthesis will require excessive
force and may damage the voice prosthesis.
6. Attach the Loading Tube to the top of the Folding Device / Guide (Fig. 4.6) and let
the two parts snap together.
The Provox Vega XtraSeal voice prosthesis is now ready for activation and can be used
as described in section "Anterograde Replacement Procedure using overshooting".
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