English; Intended Use; Contraindications; Device Description - Atos Medical Provox Dilator 7211 Mode D'emploi

The manual, 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.

Intended use

The Provox Dilator is intended for upsizing
smaller tracheo-esophageal (TE) punctures (i.e.
from 16 Fr diameter) to allow fitting of Provox
voice prostheses, or upsizing a shrunken puncture
to an adequate diameter i.e. after loss of a voice
prosthesis.
The dilator may also be used for temporary
blockage of a TE puncture or to temporarily
prevent such from shrinkage.
It is only intended to be used by physicians or
speech pathologists/therapists trained in the care
and rehabilitation of laryngectomized patients.

Contraindications

• The device is not intended to be used for
puncture dilation at the time of surgical
creation of the puncture.
• Do not use the device in case of a small
tracheostoma where the dilator could obstruct
breathing.

Device description

Provox Dilator is a stepwise tapered, about
140 mm (5.5 inch) long solid curved rod made of
medical grade silicone. The diameter is 15 Fr at
the tip and increases to 24 Fr. At the end of each
diameter step, i.e. 18, 20 and 22 Fr respectively,
a small retaining collar is made to prevent the
dilator from gliding back to the thinner section.
The dilator also has a retainer strap with medallion
intended to reduce the risk of accidental aspiration.
WARNINGS
• To avoid cross contamination, use appropriate
hygienic procedures and make sure that each
used device is cleaned, disinfected, dried and
steam sterilized.
• Do not use the device if it shows any sign of
structural damage.
• The material in the Provox Dilator withstands
50 cleaning and steam sterilization procedures
at 137°C/278°F for 3 minutes or at 134°C/273°F
for 18 minutes. Always ensure mechanical
integrity before each use.

ENGLISH

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