5
The preloaded Puncture Dilator contains the following functional characteristics and components:
• a dilator (Fig. 1.4.1),
• a dilator strap (Fig. 1.4.2) connecting the dilator and the voice prosthesis interface,
• a dilator loop (Fig. 1.4.3) constituting the voice prosthesis interface,
• a Wirelock (Fig. 1.4.4) containing interfaces to the voice prosthesis safety strap (Fig. 1.4.6) and to the
Guidewire,
• a Provox Vega voice prosthesis (Fig. 1.4.5) with its safety strap (Fig. 1.4.6) connected to the
Wirelock and oriented so that the tracheal flange (Fig. 1.4.7) of the voice prosthesis is facing
towards the Wirelock.
The Provox Vega voice prosthesis contains a one-way valve that keeps the TE-puncture open for
speech, while reducing the risk of fluids and food entering the trachea.
The Provox Vega voice prosthesis is not a permanent implant, and needs periodic replacement.
The prosthesis is available in different diameters and several sizes.
The set also includes the following non-sterile items:
• 1 Instructions for use - Provox Vega Puncture Set
(including 1 Illustration manual)
• 1 Provox Vega Patient’s Manual
• 1 Provox Brush of a size corresponding to the voice prosthesis
• 1 Provox Brush Instructions for Use
1.4 WARNINGS
Pre-surgery
•
DO NOT
use the product if the package is damaged or opened. Unsterile product may cause
infection.
•
DO NOT REUSE
and
DO NOT RESTERILIZE
by any method. This device is intended for
single use only. Reuse may cause cross contamination. Cleaning and resterilization may cause
structural damage to the device.
•
DO
proceed with great care if the patient has received radiotherapy with or without concurrent
chemotherapy. These circumstances increase the risk of puncture-related complications (e.g.,
widening, granulation, atrophy). Therefore, ensure that the tissue integrity is sufficient for creation
of a TE puncture.
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.
Unregistered
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