Fahl LARYNGOTEC PRO Instrucciones De Uso página 10

LARYNGOTEC
EN
I. FOREWORD
These instructions for use are valid for Fahl
the physician, nursing staff and patient/user in order to ensure technically correct handling of Fahl
tracheostomy tubes.
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.
II. INTENDED USE
Fahl tracheostomy tubes are intended to stabilise the tracheostoma following laryngectomy or
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tracheostomy.
The tracheostomy tube is designed to keep the tracheostoma open.
When used for the first time the products must only be selected, used and inserted by clinicians or medical
professionals trained in their use.
Users must be trained by medical professionals on how to use the Fahl
safely and appropriately.
Fahl LINGO tube variants are intended for tracheotomised patients who retain their larynx or for ®
laryngectomees who use a shunt valve (voice prosthesis users).
III. WARNINGS
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 insertion. The replacement
tube must be inserted immediately, even before cleaning and disinfecting the changed tube.
Patients must be trained by medical professionals on how to use the Fahl
safely.
Fahl tracheostomy tubes must never be blocked, e.g. by mucus or encrustation. Blockage can
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cause asphyxiation!
Mucus in the trachea can be aspirated (removed by suction) through the tracheostomy 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.
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 electrosurgical
devices! Contact with a laser beam may damage the tube.
CAUTION!
Tracheostomy tubes with speech function are only recommended for tracheotomised patients
with normal secretion and normal mucous tissue.
If there is strong secretion, a tendency to form granulation tissue, if the patient is undergoing
radiation therapy or if scabs have formed, a perforated cannula version is only recommended
under regular surveillance by a doctor and provided that shorter replacement intervals are
observed (as a rule once a week), because the perforations in the outer tube can increase the
formation of granulation tissue.
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/button that was not sized correctly may need to be removed by a doctor/
physician. If mucus blocks the tube/button it should be removed and cleaned.
V. CONTRAINDICATIONS
Do not use if the patient is allergic to the material.
Do not use with ventilated patients.
VI. PRECAUTIONS
The correct tracheostomy tube size should be selected by the treating physician or by trained medical
professionals.
When using Fahl
(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.
PRO TRACHEOSTOMY TUBES
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tracheostomy tubes, the products may become infected for instance with yeast
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tracheostomy tubes. The instructions for use serve to inform
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tracheostomy tubes
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tracheostomy tubes
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