Alaxo AlaxoStent C, Instructions For Use Manual

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4 Use
The AlaxoStent is a medical device and has been
developed and clinically 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 braid in good order over the allowed period of
use of max. 18 months.
4.1 Preparation of the AlaxoStent 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 XX 2).
2. The other end of the pusher [2b] is inserted into 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 and the end of the stent shortly before
the black end. (see XX 3)
4.2 Introduction of the AlaxoStent into the throat
1. The introduction tube is carefully introduced with the
black end ahead into the right or left nostril and
advanced horizontally through the nasal passage
according to XX 4 down to the throat (tilt the head
back!). Exact positioning of the nitinol braid is explained
to the patient by the prescribing doctor. In each case
the AlaxoStent stays away from the epiglottis.
2. The smooth material and the bent form of the intro
duction tube serves for good steerability at the end of
the nasal passage down to the throat and is optimally
adapted to the human anatomy. Nevertheless, differen
ces in simplicity of the introduction process may arise
e.g. from anatomic variability from patient to patient.
3. In case of dry mucosal tissue in the nose pushing
forward of the introduction tube may lead to increased
friction. To wetten the nasal mucosa, after consultation
of the attending physician, a nasal spray containing sea
salt, dexpanthenol and/or hyaluronic acid may be
applied horizontally into the nasal passage.The
introduction tube smoothly moves forward along the wet
mucosal tissue with low friction.
4. After reaching the right position the pusher is held with
the one hand and the introduction tube is slowly retrac
ted over the pusher with the other hand. The nitinol
braid self-expands first in the throat and then in the
nasal passage and attaches itself towards the walls of
the throat.
5. Once the introduction tube is fully removed the clip lock
is pulled apart and thereby the pusher is separated
from the nitinol braid. The AlaxoStent thus is in its
position of use (see XX 4). Cleaning of the introduction
tube is described in Section 4.4.
6. To secure the position of the AlaxoStent in the throat
the part of the nitinol braid protruding from the nose is
affixed with the fixation tape at the upper lip, the nose
or the cheek (see XX 5). It has to be made sure that the
fixation tape securely adheres to the nitinol braid.
7. Application of the AlaxoStent is completed and the
patient can go to sleep.
8. Due to the opening force of the nitinol braid the throat
is kept open and a collapse of the airway is prevented.
Differences in the efficacy of splinting of the airway may
be observed from patient to patient.
4.3 Removal of the AlaxoStent
After sleep the fixation tape is cautiously removed and the
nitinol braid retracted from the nose and throat.
4.4 Cleaning of the AlaxoStent
1. After retraction from the nose the introduction tube is
rinsed in lukewarm (not hot !!!) flowing drinking water
until all potentially adhering mucus is removed.
2. The outer surface of the introduction tube is sprayed
with the cleaning spray (Prontosan® Wound Spray)
which is also sprayed into the end of the introduction
tube. The cleaning spray has to act for one minute and
then the introduction tube is let dry.
3. The nitinol braid is rinsed in lukewarm (not hot !!!)
flowing drinking water immediately after retraction from
the nose until all potentially adhering mucus is mostly
removed.
4. The nitinol braid is pushed over the cleaning tube [4]
and potentially adhering contaminations are carefully
removed in lukewarm flowing drinking water with the
fingers. For bringing the nitinol braid onto the cleaning
tube its open end is cautiously pushed over one end of
the tube (do not pull!!!). Subsequently push the whole
nitinol braid over the tube as shown in XX 6. Removal
of contaminations from the nitinol braid with the fingers
has to be done only in longitudinal direction, never
in cross direction (i.e. not around the cleaning tube)
as otherwise the sensitive nitinol braid may be
damaged.
5. Once the nitinol braid is completely cleaned it is
cautiously pushed off the cleaning tube with the thumb
and one finger without exerting any pressure from the
lower end to the upper end (see XX 7). Please do not
pull the closed end nor the clip lock of the nitinol braid
as it will contract due to its design and cannot be pulled
off the cleaning tube!
6. Subsequently the nitinol braid is sprayed with the
cleaning spray (Prontosan® Wound Spray) which has
to act for one minute. Then the nitinol braid is rinsed
once more in lukewarm flowing drinking water, again
sprayed with the cleaning spray and let dry.
7. The cleaning tube and the pusher are rinsed, too, in
lukewarm flowing drinking water, sprayed with the
cleaning spray (Prontosan® Wound Spray) which has
to act for one minute and then let dry.
The three-step cleaning procedure for the AlaxoStent
serves for disinfection. By extensive rinsing the
contaminations are efficiently removed. The 0.1%
polyhexanide / 0.1% betaine cleaning spray (Prontosan®
Wound Spray) additionally reaches all interspaces due
to its modified surface tension. The ingredients possess
excellent mucosa compatibility and a broad pathogen
spectrum.