Descriptive Information; Intended Use; Description Of The Device - PROVOX LaryTube Manual De Instrucciones

1. Descriptive information

1.1 Intended use

The Provox LaryTube is a holder for devices in the Provox HME System intended
for vocal and pulmonary rehabilitation after total laryngectomy.
For patients with a shrinking tracheostoma it is also used to maintain the
tracheostoma for breathing.
The Provox LaryTube is intended for single patient use.
1.2 CONTRAINDICATIONS
Provox LaryTube is not intended to be used by patients that:
• are under any form of mechanical ventilation.
• have damaged tracheal or tracheostoma tissue.

1.3 Description of the device

The Provox LaryTube is a tube made of medical grade silicone rubber. The
purpose of the device is to create a comfortable and airtight fit between the
Provox LaryTube and the tracheostoma, and also to provide attachment for
devices from the Provox HME System.
They are delivered single packed, non-sterile.
There are 3 models: Standard, Fenestrated and with Ring (Fig. 1).
The Standard model and the Ring version can be fenestrated so that air can go
through the voice prosthesis for voice prosthesis users. The holes are punched
by using the Provox Fenestration Punch according to the Instructions for Use
accompanying the Provox Fenestration Punch, see ordering information.
Standard versions (Fig. 1a) – made for use with or without a voice prosthesis.
Can be attached with a Provox TubeHolder or Provox LaryClips.
Fenestrated versions (Fig. 1b) – For voice prosthesis users.
Can be attached with a Provox TubeHolder or Provox LaryClips.
Ring versions (Fig. 1c) – made for use with or without a voice prosthesis.
Can only be attached with a Provox Adhesive.
The different parts of the Provox LaryTube are (Fig. 1d-i):
d) Tube
e) Shield (conical)
ENGLISH
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