Intended Use; Device Description - Atos Medical Provox Dilator 17 Manual

Intended use

Provox voice prosthesis system is intended for
use of prosthetic voice restoration after total
laryngectomy.
Provox Dilator 17 and Provox Dilator 20
are used for dilating tracheo-esophageal (TE)
punctures that shrink very fast or are too narrow
to insert the selected Provox voice prosthesis.
The dilator may also be used to temporarily
block or stent the TE puncture.
For Home Care Use the dilator is intended for
single patient re-use, and may only be used
as part of Provox NID system. It shall only
be used by patients with sufficient manual
dexterity, acceptable vision and satisfactory
cognitive ability.
For Professional Use the dilator may be re-used
by a clinician in clinic and shall be re-sterilized
between patients.
Contraindications
• The device is not intended to be used by
patients that have not received adequate
training by their clinician.
• 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 17 and Provox Dilator 20 are
tapered curved silicone rods used for dilating
(increase the diameter of) TE punctures. Provox
ENGLISH
13