Intended Use - Fahl DURATWIX JUNIOR Manual Del Usuario

DURATWIX
I. FOREWORD
These instructions for use are valid for Fahl
serve to inform the physician, nursing staff and patient/user in order to ensure technically
correct handling of Fahl
Please read the instructions for use carefully before using the product for the first
time!
Keep them in an easily accessible place for future reference.
Please keep the package for as long as you use the tracheostomy tube. It contains important
information on the product!
II. INTENDED USE
Fahl tracheostomy tubes are intended to stabilise the tracheostoma following laryngectomy
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or tracheostomy.
The tracheostomy tube is designed to keep the tracheostoma open.
Tracheostomy tubes with cuff are always indicated after tracheostomy has been performed
for any cause if the cannula needs to be sealed against the wall of the trachea.
When used for the first time the products must only be selected, used and inserted by clini-
cians or medical professionals trained in their use.
Users must be trained by medical professionals on how to use the Fahl
stomy tubes safely and appropriately.
III. WARNINGS
Patients must be trained by medical professionals on how to use the Fahl
stomy tubes safely.
Fahl tracheostomy tubes must never be blocked, e.g. by mucus or encrustation.
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Blockage can cause asphyxiation!
Mucus in the trachea can be aspirated (removed by suction) through the tracheo-
stomy tube with a tracheal suction catheter.
Damaged tracheostomy tubes must not be used and must be discarded immediately.
Use of a damaged tube may result in airway compromise.
When the tracheostomy tubes are inserted or removed, this can lead to irritations,
coughing or slight bleeding. If bleeding persists, consult your doctor immediately!
Tracheostomy tubes are single-patient products and intended for use by one patient
only.
Do not re-use with another patient. Do not reprocess for re-use by another patient.
Do not use tracheostomy tubes during laser treatment (laser therapy) or with electro-
surgical devices! Contact with a laser beam may damage the tube.
In case of an unstable tracheostoma, the airways must always be secured before
removing the tracheostomy tube and a replacement tube must be kept ready for in-
sertion. The replacement tube must be inserted immediately, even before cleaning
and disinfecting the changed tube.
IV. COMPLICATIONS
The following complications could emerge when using this device:
Contamination of the stoma may make it necessary to remove the tube. Contaminations can
furthermore cause infections that necessitate the use of antibiotics.
Unintentional Inhalation of a tube that was not sized correctly may need to be removed by a
doctor/physician. If mucus blocks the tube it should be removed and cleaned.
V. CONTRAINDICATIONS
Do not use if the patient is allergic to the material.
CAUTION!
Never under any circumstances use cannula variants without cuff for patients on
mechanical ventilation!
JUNIOR TRACHEOSTOMY TUBE
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tracheostomy tubes.
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tracheostomy tubes. The instructions for use
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