PROVOX Vega Manual De Instrucciones página 9

During surgery
General
• DO ensure that the Pharynx Protector is inserted deep enough into the esophagus before performing
primary TE puncture, by palpating the TE wall. Puncture without proper positioning of the Pharynx
Protector may cause tissue damage.
• DO ensure that the Guidewire is inserted through the needle and through the lumen of the Pharynx
Protector so that it does not damage the TE wall.
• DO ensure that the Puncture Needle is removed before removing the pharynx protector.
The Puncture Needle may cause tissue damage without proper pharynx protection.
• DO ensure that the Puncture Dilator is mounted on the esophageal end of the Guidewire and not
the tracheal. The dilatation should be performed in the posteroanterior direction. Dilatation in the
wrong direction causes reversed placement of the voice prosthesis, which causes aspiration and
inability to speak.
• DO NOT withdraw the Guidewire back through the Puncture Needle. Damage, shearing and/or
scraping of the Guidewire may occur. If the Guidewire must be withdrawn, remove the Guidewire
and the Puncture Needle simultaneously, as one unit, to prevent the Puncture Needle from damaging
the Guidewire.
• DO NOT use toothed hemostats or other instruments that may damage the product.
Secondary puncture
• DO NOT use the included Pharynx Protector during Secondary punctures. It is only intended to be
used during Primary punctures.
• DO ensure that the pharyngeal/esophageal tissue is adequately protected, e.g., by use of a rigid
endoscope before performing secondary TE puncture.
Post surgery
Use of the voice prosthesis
Dislodgement or extrusion of the Provox Vega voice prosthesis from the TE puncture and subsequent
ingestion, aspiration or tissue damage may occur. For further information about these events and how
to prevent them, see section Adverse Events and Trouble Shooting Information below.
To reduce the risk of dislodgment or extrusion and its potential consequences:
• DO select the proper prosthesis size (i.e. length). A tight fit due to a too short voice prosthesis may
cause tissue necrosis and extrusion.
• DO instruct the patient to only use genuine Provox accessories of corresponding size and diameter
(e.g., Brush, Flush, Plug) for maintenance and to avoid all other kinds of manipulation.
• DO instruct the patient to consult a physician immediately if there are any signs of tissue edema
and/or inflammation/infection.
• DO choose laryngectomy tubes or stoma buttons, if used, with a suitable shape that do not exert
pressure on the prosthesis during use, or catch onto the tracheal flange of the prosthesis during
insertion and removal of the tube or button.
1.5 PRECAUTIONS
Always assess the suitability of the tissue in the area of the TE puncture. In cases with lacking
suitability, e.g. due to excessive scar tissue or radiation fibrosis, proceed with great care and abort
the procedure if dilatation of the TE puncture requires too much force.
• DO carefully assess patients with bleeding disorders or patients undergoing anticoagulant treatment
for the risk of bleeding or hemorrhage, prior to secondary puncture and prosthesis placement.
• DO always use aseptic technique when handling the Puncture Set in order to reduce risk for
infection.
• DO remove the Pharynx Protector before initiating dilatation. The voice prosthesis may get stuck
inside the Pharynx Protector if attempting to complete the procedure without removing the Pharynx
Protector.
• DO ensure that the Guidewire is adequately threaded and locked in position in the Wirelock.
If proper locking is not achieved, the Guidewire may come loose from the Wirelock, causing failure
to complete procedure.
• DO always proceed slowly and without using excessive force during dilatation and placement of
the prosthesis. Tissue damage may otherwise occur.
• DO support the TE tissue during dilatation. Otherwise, rupture may occur. In case of a rupture of
the TE tissue the TE puncture procedure should be abandoned and the rupture should be sutured
immediately. TE puncture should only be repeated after proper healing of the tissues.
• DO NOT reload after the safety strap of the prosthesis has been cut off, as the safety mechanism
in that case has been compromised, with risk for dislocation of the voice prosthesis during the
procedure.
1.6 Adverse events and troubleshooting information
1.6.1 During use of the Puncture Set
(Sub-) mucosal injury
During puncture, the Puncture Needle or the Guidewire could cause a (sub) mucosal injury if the
Pharynx Protector is not located in its correct position, or if the puncture is made incorrectly. In case
of suspicion of (sub)mucosal damage, it is recommended that the patient receives a prophylactic
course of postoperative antibiotics and is fed through a nasogastric tube or similar to allow healing.
Re-puncture
If the Pharynx Protector is not positioned appropriately when puncturing, or if, for any other reasons,
there is need for re-puncture, the tissue should be assessed for possible sub-mucosal injury and the
puncture procedure repeated with the Pharynx Protector positioned correctly.
Forgot to remove the Pharynx Protector
If the Puncture Dilator is connected to the Guidewire prior to removal of the Pharynx Protector, the
procedure cannot be completed. If this occurs, detach the Puncture Dilator from the Guidewire and
remove the Pharynx Protector. Also see Reloading below.
Reloading
In some cases, reloading of the Puncture Dilator may be necessary; e.g., if the voice prosthesis is
pulled completely through the puncture during prosthesis placement. The reloading procedure is
described in section 2.2.3 and illustrated in Fig. 4.
1.6.2 During use of the voice prosthesis
Dislodgement of the voice prosthesis– Dislodgement can be caused by infection and/or edema of
the TE-puncture, granulation around the puncture or hypertrophic scarring around the puncture.
Dislodgement might lead to aspiration or ingestion of the prosthesis. See below.
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