English; Descriptive Information; Intended Use; Description Of The Device - Atos Medical PROVOX LaryButton Instrucciones De Uso

1. Descriptive information

1.1 Intended use

The Provox LaryButton is a self-retaining 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 LaryButton is intended for single patient use.
1.2 CONTRAINDICATIONS
Provox LaryButton is not intended to be used by patients that:
• are under any form of mechanical ventilation.
• have damaged tracheostoma tissue.

1.3 Description of the device

The Provox LaryButton is a self-retaining tracheostoma button
made of medical grade silicone rubber. The purpose of the
device is to create a comfortable and airtight fit between the
Provox LaryButton and the tracheostoma, and also to provide
attachment for devices from the Provox HME System. The
device is delivered single packed, non-sterile and ready to use.
The different parts of the Provox LaryButton are (Fig. 1):
a) Retention Collar
b) Shaft
c) Shield (conical)
d) HME and Accessory Holder
e) Wings

ENGLISH

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