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Careful traction on the GuideWire brings the strap of the voice
prosthesis into the TE-puncture. The voice prosthesis is carefully
rotated into position with two non-toothed hemostats firmly
holding the tracheal flange (Fig 3.5).
CAUTION:
Do not pull the voice prosthesis in place with the
GuideWire.
6. When the voice prosthesis is correctly positioned, the safety
strap is cut off while still attached to the GuideWire and the
voice prosthesis is turned so that the part where the safety strap
was attached points downwards into the trachea (Fig 3.6).
2.2.3 Replacement procedure (Fig 4):
Anterograde vs. retrograde insertion
If the sterile indwelling Voice Prosthesis cannot be inserted in an
anterograde manner, retrograde insertion by use of the Provox
GuideWire may be performed.
Replacement should be carried out as an outpatient procedure using
local anaesthesia. Occasionally, the procedure may be carried out
under general anesthesia upon determination by the physician.
Anterograde removal of the old prosthesis (not Provox(1)):
1. Grasp the tracheal flange with a non-toothed hemostat and
pull the prosthesis out from the TE puncture.
2. Insert the GuideWire through the TE puncture and push the
GuideWire upwards through the pharynx and out of the mouth.
Retrograde removal of the old prosthesis (Only Provox(1)):
The old Provox(1) voice prosthesis can be removed transorally by
the use of the Provox GuideWire.
1. While the old voice prosthesis is still in situ, introduce the
GuideWire through the old prosthesis and push the GuideWire
upwards through the pharynx and out of the mouth.
2. Grasp the tracheal flange of the prosthesis with a non-toothed
hemostat. Cut it off the tracheal flange with a scalpel and remove it.
With the tracheal flange removed, the Stopper of the GuideWire
will pull the remains of the old voice prosthesis into the esophagus
and up through the mouth. Discard the old voice prosthesis.
Placement of a sterile indwelling Provox Voice Prosthesis:
The GuideWire Connector is now outside the mouth (Fig 4.1).
3. Attach and secure the new voice prosthesis to the GuideWire
Connector. Pull the GuideWire downwards, towards the existing
TE-puncture. Careful traction on the GuideWire brings the strap
of the voice prosthesis in to the TE-puncture (Fig 4.2).
CAUTION:
Do not pull the voice prosthesis in place with the
GuideWire.
4. Introduce the tracheal flange of the voice prosthesis into the
puncture with the help of a non-toothed hemostat. Then turn the
voice prosthesis so that the safety strap is pointing downwards,
into the trachea. Let the patient drink and swallow while observing
the voice prosthesis, to ensure no leakage occurs. Cut off the
safety strap while it is still attached to the GuideWire and discard
the GuideWire (Fig 4.3).
2.3 Cleaning and sterilization
The Provox GuideWire is provided sterile (EO) and intended for
single use only and can NOT be cleaned or resterilized.
2.4 Disposal
After use, the product may be a potential biohazard. Handling and
disposal should be carried out in agreement with medical practice
and applicable national laws and legislations.
Unregistered
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Summary of Contents for Provox GuideWire
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