Intended Use - Atos Medical Provox XtraHME Instrucciones De Uso

Speaking with a voice prosthesis
If you have a voice prosthesis and you have been cleared to use it for speaking,
the lid of Provox XtraHME can be pressed down with your finger to occlude
the stoma for speaking. After releasing the finger pressure, the lid opens and
you can breathe (Fig. 1.2).
CONTRAINDICATIONS
This device shall not be used by patients who are unable to handle or remove
the device themselves when needed, unless the patient is under constant
supervision of a clinician or a trained caregiver. For example: patients who are
unable to move their arms, patients with decreased levels of consciousness,
or patients with diseases that put them at a risk for unpredictable periodic loss
of consciousness.
WARNING
Be careful not to exert pressure on the lid of the HME unintentionally. Unin-
tentional closing of the lid may cause difficulty in breathing.
PRECAUTIONS
• Always test the function of Provox XtraHME prior to use. The top lid should
immediately return to its open position after releasing the pressure.
• Do not disassemble Provox XtraHME since this will interfere with its proper
function.
• Do not reuse Provox XtraHME or attempt to rinse it with water or any other
substance. This will substantially reduce the function of the HME. It also
increases the risk of potential infections since e.g. bacteria may start to grow
in the foam.
• Do not use Provox XtraHME longer than 24 hours. This will increase the
risk of potential infections since e.g. bacteria may start to grow in the foam.
Provox® Micron HME™
Provox Micron HME is not available in all countries. In the US and Canada,
this product is available on prescription only.

Intended use

The Provox Micron HME is a heat and moisture exchanger (HME) and air
filtration device for laryngectomized patients. Provox Micron HME partially
restores lost breathing resistance. For patients with a voice prosthesis or surgical
speech fistula it may also facilitate voicing.
Provox Micron HME is intended to be used with the attachment devices in
the Provox HME System.
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