Alaxo AlaxoLito, Instructions For Use Manual, Page: 32 / 108

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4 Use
The AlaxoLito Nasal Stent is a medical device and has been developed
and tested for self-application by the patient. The nitinol braid consists of thin
and sensitive metal wires so that the braid needs to be treated carefully and
gently. The following instructions for handling and cleaning have to be obeyed
to in order to maintain the nitinol braids in good order over the allowed period
of use of 18 months.
4.1 Preparation of the AlaxoLito stent for introduction
1. The nitinol braid is connected to the pusher [2] by fitting into each other the
two parts [1a] and [2a] of the clip lock ( see X 2 ).
2. The other end of the pusher is inserted into the black end [3a] of the
introduction tube [3] and the pusher is moved through the introduction tube.
Then the nitinol braid is carefully and completely pulled into the introduction
tube using the pusher whereby it self-compresses. The clip lock shall be
located in the introduction tube. ( see X 3 )
4.2 Introduction of the AlaxoLito stent into the nose
1. The introduction tube containing the nitinol braid is carefully introduced with
the black end ahead into the left or right nostril as far as the clip lock still
being outside of the nose ( XX 4 ).
2. The pusher is held with the one hand and the introduction tube is slowly
retracted over the pusher with the other hand. The nitinol braid
self-expands and thereby attaches itself towards the walls of the nose.
Thus the AlaxoLito stent is safely and stably positioned.
3. Once the introduction tube is fully removed the clip lock is pulled apart and
thereby the pusher is separated from the nitinol braid.
4. Subsequently the other stent is introduced into the other nostril in the same
way.
5. Cleaning of the introduction tube is described in Section 4.4.
4.3 Removal of the AlaxoLito stent
1. For removal the two nitinol braids are cautiously pulled out of the nose.
Should the nasal mucosa have dried out it is recommended to first moisten
the mucosa.
2. For that purpose a nasal spray containing sea salt, dexpanthenol and/or
hyaluronic acid may be sprayed into the nose.
4.4 Cleaning of the AlaxoLito Nasal Stent
1. After retraction from the nose the introduction tube is rinsed in lukewarm