Atos Medical Provox Vega XtraSeal, Руководство для клиницистов

Страница: 11 / 140

11
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 damaged or opened, do not use
the product.
• Always use aseptic technique when handling the prosthesis to
reduce infection risk.
• Make sure that any external or internal stoma attachment devices
used do not exert pressure or hook the flange of the prosthesis
(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 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 flange.
2.2 Anterograde replacement procedure using
overshooting
(Fig. 3.1 – 3.10)
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.
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 finger (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 flange of the prosthesis with a
non-toothed hemostat (Fig. 3.6).
4. Checking the proper fit
Check to see if the prosthesis and the flanges are in the proper
position by rotating and moving the prosthesis back and forth
in the puncture. Apply slight traction on the tracheal flange to
ensure proper retention of the voice prosthesis (Fig 3.7).
Caution:
Confirm that both esophageal flanges have deployed
entirely in the lumen of the esophagus. No part of the enlarged
esophageal flange 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 flange completely. In case of uncertainty, use flexible
endoscopy to confirm 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).