Tabla De Contenido; Descriptive Information; Indications For Use; Contraindications - Atos Medical Provox Vega Instrucciones De Uso

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.
Contents
1. Descriptive information .....................................................................................................................4
1.1 Indications for use .........................................................................................................................4
1.2 CONTRAINDICATIONS ..................................................................................................................4
1.3 Description of the device ...........................................................................................................4
1.4 WARNINGS .......................................................................................................................................5
1.5 PRECAUTIONS .................................................................................................................................6
1.6 Adverse events and troubleshooting information ............................................................6
1.6.1 During use of the Puncture Set .........................................................................................6
1.6.2 During use of the voice prosthesis ..................................................................................6
2. Instructions for use ..............................................................................................................................7
2.1 Preparation ......................................................................................................................................7
2.2 Operating instruction ..................................................................................................................7
2.2.1 Primary puncture and prosthesis placement ..............................................................8
2.2.2 Secondary puncture and prosthesis placement ........................................................8
2.2.3 Reload of the Puncture Set .................................................................................................9
2.3 Cleaning and sterilization ...........................................................................................................9
2.4 Important patient information .................................................................................................9
2.5 Device lifetime of the Provox Vega voice prosthesis ..................................................... 10
2.6 Disposal .......................................................................................................................................... 10
2.7 Accessories.................................................................................................................................... 10
3. Additional information ................................................................................................................... 10
3.1 Ordering information ................................................................................................................ 10
3.2 User assistance information ................................................................................................... 10
Please see accompanying Illustration manual for illustrations referenced in this
Instructions for Use.
Stomal airway management
Emergency situations
It is important that emergency personnel knows that you are a neck breather. This will
help them determining that oxygen and rescue breathing need to be administered to your
stoma and not to your mouth or nose.
We recommend that you and your clinician download the guidelines for rescue breathing
from www.atosmedical.com/rescuebreathing
Elective situations
If you need to undergo a procedure that requires intubation (putting a breathing tube
in your windpipe), it is very important that the anesthesiologist and the doctor who is
performing the procedure are aware that you are a neck breather and that you are using
a voice prosthesis. It is important for them to understand that the voice prosthesis should
stay in place. If it is removed, fl uids from your mouth, food pipe, or stomach may get
into your windpipe.
It is very important that the intubation tube is inserted and removed carefully so that
the voice prosthesis does not dislodge or come out.

1. Descriptive information

1.1 Indications for use

Provox Vega Puncture Set is a device for performing a primary or secondary tracheo-
®
esophageal (TE) puncture in laryngectomized patients, with integrated placement of a
Provox Vega voice prosthesis.
The Provox Vega voice prosthesis is a sterile single use indwelling voice prosthesis
intended for voice rehabilitation after surgical removal of the larynx (laryngectomy).
Cleaning of the voice prosthesis is performed by the patient while it remains in situ.

1.2 CONTRAINDICATIONS

Do not use the Provox Vega Puncture Set if the patient has anatomical abnormalities that may
hinder safe puncturing of the TE wall or safe voice prosthesis placement (e.g., signifi cant
stenosis or signifi cant fi brosis at the puncture site) as this may cause tissue damage.
Do not use the Provox Vega Puncture Set for secondary TE puncture if the patient suffers
from severe trismus that precludes proper protection of the pharyngeal wall. Failure to
protect the pharynx during puncture may lead to unintended trauma of the pharyngeal/
esophageal tissue.

1.3 Description of the device

The Provox Vega Puncture Set is a device for creating a primary or secondary TE puncture,
with subsequent dilatation of that puncture to a width that facilitates placement of the
included Provox Vega voice prosthesis. The Provox Vega voice prosthesis is preloaded
on the Puncture Dilator, which is part of the device.
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ENGLISH