English; Intended Use; Description Of The Device - Atos PROVOX Luna Mode D'emploi

ENGLISH

ENGLISH
The Instructions for Use, which accompanies this product, may be revised from
time to time and must therefore be reviewed prior to each procedure in which the
product is used.
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
6
(Carbon dioxide) retention.
2
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.
1.5 PRECAUTIONS
• Be careful not to exert pressure on Provox Luna HME unintentionally.
Pressure may reduce the size of the side openings and cause difficulty
breathing.
• Do not reuse Provox Luna HME as the risk of potential infections may
increase due to bacterial colonization of the HME.
• Do not rinse Provox Luna HME with water or any other substance since this
will substantially reduce the function of the HME.
• Do not remove the HME foam, as the HME function will be lost.
• The Provox Luna Adhesive may be used on irritated skin. However, if skin
irritation persists for more than 14 days, stop using the adhesive and consult
your clinician.
• If new skin irritation develops, stop using the Provox Luna Adhesive and
consult with your clinician.
2. Instructions for use
2.1 Operating Instructions
Clean the skin around the stoma and let it dry before attaching the Provox Luna Adhesive.
Caution: Do not use skin barrier products or skin cream.
For instructions on how to apply the products, please see fig. 1-8.
In order to get a seal for speech, occlude Provox Luna HME by covering the openings
on the sides (fig. 9).
The Provox Luna HME can be removed (as in fig. 10) if mucus needs to be cleaned from
the stoma. Provox Luna Adhesive can stay in place during cleaning of the stoma and
changing the HME.
In the morning, carefully remove the Provox Luna Adhesive. Using a little bit of water at
the side and underneath the adhesive helps to remove the adhesive.
Caution: When taking a shower with the Provox Luna Adhesive use the Provox Luna
ShowerAid and Provox Adhesive Strip. The hydrogel adhesive material may absorbe
water and detach.
7