Fahl TRACHEOTEC Instrucciones De Uso página 18

CAUTION!
Contraindicated in patients with increased bleeding tendency (e.g. during anticoagulant thera-
py). In such cases, the Suction tracheostomy tube with suction opening may not be used, since
suctioning entails an increased risk.
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4. Inner cannula (if present)
The inner cannulas can easily be removed from the outer cannula, thus allowing the air supply to be
increased quickly if necessary (for instance in case of dyspnoea).
The inner cannula can now be removed from the outer cannula by pulling it gently (see picture 16).
Inner cannulas must never be used without outer cannula but must always be affixed to the outer
cannula.
CAUTION!
Make sure to read all accompanying product information, instructions for use, indications and
contraindications. Discuss use of the product with your doctor/physician before first use.
VIII. DIRECTIONS FOR TUBE INSERTION AND REMOVAL
For the Doctor/Physician
The appropriate tracheostomy tube must be selected by a doctor/physician or trained medical pro-
fessionals.
Select a tube that fits the patient's anatomy to optimise comfort and ventilation (breathing in and out).
The inner cannula (if present) can be removed at any time to increase air supply or for cleaning. This
can for instance be necessary if the cannula is clogged up with secretion residues which cannot be
removed by coughing or because no equipment for suctioning off the secretions is available.
For the Patient
CAUTION!
Always insert the tracheostomy tube with the cuff in fully deflated condition (see picture 7a)!
CAUTION!
Carefully examine the sterile packaging to ensure that it has not been tampered with or dam-
aged. Do not use the product if the packaging has been damaged.
Check the use­by 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 re-
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moved 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.
When using Fahl tracheostomy tubes, the products may become infected for instance with yeast
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(Candida), bacteria or the like, which may lead to the material becoming cloudy and its service life being
shortened. Should this occur, the tube must be replaced immediately.
WARNING
Patients must be briefed by trained medical professionals in the safe use of the Fahl trache-
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ostomy tubes.
1. Insertion of the tube
Step­by­step 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 obturator is to be used, this must first be fully inserted into the cannula tube so that the collar on
the gripping piece of the obturator comes into contact with the outer edge of the 15 mm connector and
the tip of the olive projects beyond the tip of the cannula (proximal end of cannula). The obturator must
be held in this position during the entire procedure.
When using tracheostomy tubes with cuff, pay special attention to the following points:
Before inserting the tracheostomy tube, check the cuff (balloon) as well - the cuff 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, 3.1.1). The balloon
must be completely empty 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.
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