Atos Medical Provox GuideWire, Инструкция по эксплуатации

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The Instructions for Use, which accompanies this product, may
be revised from time to time and must therefore be reviewed prior
to each procedure in which the product is used.
1. Descriptive Information
1.1 Indications for use
The Provox GuideWire is a sterile single use insertion device
intended for placement of a sterile Provox indwelling Voice
Prosthesis after total laryngectomy (primary or secondary puncture),
or for retrograde replacement of a sterile Provox indwelling Voice
Prosthesis.
1.2 Contraindications
Do not use if the patient has anatomical abnormalities, e. g.
significant pharyngeal stenosis above the puncture site or severe
trismus. Significant pharyngeal stenosis may preclude insertion of
the voice prosthesis. Severe trismus may preclude proper protection
of the pharyngeal wall during secondary puncture leading to harm
of the esophageal tissue.
1.3 Description of the device
The Provox GuideWire is a sterile, single use device for introduction
and replacement of sterile Provox indwelling Voice Prostheses.
The GuideWire has a connector for attachment of the safety strap
of the new voice prosthesis and an 8 mm Stopper for transoral
removal of the remnant of the old voice prosthesis.
The Provox GuideWire package contains the following items:
1 Provox GuideWire, sterile (Fig.1),
1 Instructions for use Provox GuideWire, non-sterile.
The Provox GuideWire has two functional parts (Fig.1)
1. Stopper – for transoral removal of the old Provox Voice
Prosthesis (made of ABS plastic) (Fig.1.1),
2. Connector – for attachment of a Provox Voice Prosthesis safety
strap (made of nylon plastic material (Polyamide) (Fig.1.2).
The Provox GuideWire tube is made of a PVC plastic material.
1.4 WARNINGS
Pre-surgery
• DO NOT use the product if the package or product is
damaged or opened. Unsterile product may cause infection.
• DO NOT REUSE and DO NOT RESTERILIZE by any
method. Intended for single use only. Reuse may cause
cross contamination. Cleaning and resterilization may cause
structural damage.
During insertion
• DO always proceed slowly and without using excessive
force when pulling the GuideWire through. Tissue damage or
dislodgement or extrusion of parts of the Provox GuideWire
may otherwise occur which can lead to subsequent ingestion
or tissue damage.
• DO NOT proceed if the voice prosthesis gets stuck in pharynx
or esophagus, this may lead to tissue damage.
For further information about these events, see section Adverse
events.
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