Intended Use - Fahl TRACHEOTEC Instrucciones De Uso

TRACHEOTEC
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!
The Fahl tracheostomy tubes are medical devices as defined by the MPG (German medical
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devices act) and conform to, among others, the "Basic Requirements" as per Annex IX of
Directive 93/42 EEC.
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 low pressure 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
clinicians or medical professionals trained in their use.
Users must be trained by medical professionals on how to use the Fahl
tubes safely and appropriately.
Fahl LINGO tube variants are intended for tracheotomised patients who retain their larynx
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or for laryngectomees who use a shunt valve (voice prosthesis users).
III. WARNINGS
Patients must be trained by medical professionals on how to use the Fahl
tracheostomy 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 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.
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
electrosurgical devices! Contact with a laser beam may damage the tube.
In the presence of oxygen-rich mixtures the tube may ignite, which may cause injury
from heat and exposure to decomposing and toxic combustion products.
CAUTION!
Tracheostomy tubes with speech function are only recommended for tracheotomised
patients with normal secretion and normal mucous tissue.
CAUTION!
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:
TRACHEOSTOMY TUBE
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tracheostomy tubes.
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tracheostomy tubes. The instructions for use
EN
tracheostomy
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