English; Descriptive Information; Intended Use; Contraindications - Atos Medical PROVOX Luna Handbuch

1. Descriptive Information

1.1 Intended use

The Provox Luna HME is a single use heat and moisture exchanger, attachable to
the Provox Luna Adhesive, for night-time use after total laryngectomy.
The Provox Luna Adhesive is a skin-friendly, single use adhesive that provides
attachment for the Provox Luna HME for night-time use after total laryngectomy.

1.2 CONTRAINDICATIONS

• The product shall not be used by patients with a decreased level of
consciousness, patients with reduced mobility of the arms and/or hands, or
patients who are unable to remove the device themselves.
• The product shall not be used by patients with a low tidal volume, as the added
dead space (7 ml) may cause CO

1.3 Description of the device

Provox Luna HME is a soft heat and moisture exchanger that helps to keep the lungs
healthy by humidifying the inhaled air.
Provox Luna Adhesive consists of an adhesive base, a peel-off liner and a soft connector
for the Provox Luna HME. Provox Luna Adhesive base is a skin-friendly hydrogel
adhesive intended for night-time comfort and skin rest.
Caution: Only original components should be used as other accessories may cause
product malfunction.
1.4 WARNINGS
• Do not use Provox Luna HME or Provox Luna ShowerAid with any other
adhesives or other accessories unless indicated in this Instructions for Use.
• Do not use Provox Luna Adhesive with any other HME or accessories unless
indicated in this Instructions for Use.
• Provox Luna Adhesive should not be worn during radiotherapy treatment
sessions as it will alter the delivery of radiotherapy to that area. As Provox
Luna Adhesive is a hydrogel, it is possible to use this adhesive during the
night between radiotherapy sessions; however, clinicians should be aware that
this may not be appropriate for all patients and use of Provox Luna Adhesives
needs to be assessed both on an individual basis and reviewed regularly
through the course of radiotherapy treatment.
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ENGLISH

(Carbon dioxide) retention.
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