Fahl SPIRAFLEX Instrucciones De Uso página 18

For the Patient
CAUTION!
Only insert the tracheostomy tube with the cuff in fully deflated condition (see picture 7a)!
EN
CAUTION!
Carefully examine the sterile packaging to ensure that it has not been tampered with or damaged.
Do not use the product if the packaging has been damaged.
Check the use-by or expiry date. Do not use after this date.
It is advisable to use sterile disposable gloves.
Carefully examine the tube before first use to make sure that it is not damaged and that there are no
loose parts.
Should you notice any anomaly or anything unusual, DO NOT use the tube. Return the tube to the
manufacturer for inspection.
The tube must always be cleaned and, if necessary, disinfected as follows before re-inserting
according to the instructions provided below.
If secretion collects in the lumen of the Fahl tracheostomy tube or stoma button and cannot be
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removed by coughing or aspiration, the tube should be removed and cleaned.
After cleaning and/or disinfection, carefully examine the Fahl tracheostomy tube for sharp edges,
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cracks, or other signs of damage, since these may impair function and/or injure the mucus membranes
in the airways.
Never under any circumstances continue using damaged tracheostomy tubes.
WARNING
Patients must be briefed by trained medical professionals in the safe use of the Fahl
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tracheostomy tubes.
1. Insertion of the tube
Step-by-step instructions to insert Fahl tracheostomy tubes.
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Before application, users should clean their hands (see picture 3).
Remove tube from the package (see picture 4).
If an insertion aid is to be used, then this must first be inserted into the cannula tube.
Make sure that the tip of the insertion aid
a) protrudes only a few millimetres beyond the tip of the tracheostomy tube (proximal end of tube) when
inserting the tube into the tracheostoma (see picture 13),
b) If a suction device is connected, make sure that the tip protrudes so far beyond the tip of the
tracheostomy tube (proximal end) that at least the first hole and at most the second hole (see picture
14) is fully visible.
The insertion aid must be held in this position during the entire procedure.
When using tracheostomy tubes with low-pressure cuff, pay special attention to the following
points:
Before inserting the tracheostomy tube, check the cuff (balloon) as well - it must be free of damages
of any kind and must be leakproof so as to ensure tight sealing as required. We therefore recommend
to perform a leakproofness test prior to every insertion (see Section VII, No. 3.1.1). The balloon must
be emptied completely prior to insertion of the tracheostomy tube (see picture 7b)! When using an aid
for dilating the tracheostoma, take care to ensure that the tracheostomy tube, and especially the cuff,
is not damaged by friction.
Next, push a tracheal compress, e.g. SENSOTRACH DUO (REF 30608) or SENSOTRACH 3-Plus
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(REF 30780), onto the tracheostomy tube.
To facilitate insertion of the tracheostomy tube, it is advisable to lubricate the outer tube by wiping it
with an OPTIFLUID stoma oil wipe (REF 31550) which allows the stoma oil to be applied evenly to the
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whole surface of the tube (see picture 4a and 4b).
If you are inserting the tube yourself, use a mirror to make insertion of the Fahl tracheostomy tube
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easier.
The locking screw of the neck flange is only slightly tightened to ensure that the neck flange can be
adjusted for optimum fit after the tracheostomy tube has been inserted.
When inserting the Fahl tracheostomy tube, hold it by the neck flange with one hand (see picture 5).
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Pull the tracheostoma slightly apart with your free hand to allow the tip of the tube to fit into the
tracheostoma more easily.
Special aids for dilating the tracheostoma are also available (tracheal dilator, REF 35500). These
allow the tracheostoma to be dilated gently and evenly, for instance also in emergency situations with
collapsing tracheostoma (see picture 6).
Make sure that the tube is not damaged by friction when using an instrument for assistance.
Now carefully insert the tube into the tracheostoma during the inspiration phase (while breathing in)
while tilting your head slightly back (see picture 7).
Advance the tube into the trachea.
Straighten your head once the tube has been inserted further into the trachea.
Once the tube has been brought into the correct position in the trachea, the insertion aid must be
removed and the locking screw must be tightened.
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