Intended Use - Fahl SILVERVENT Mode D'emploi

SILVERVENT
I. FOREWORD
These instructions for use are valid for Fahl
to inform the physician, nursing staff and patient/user in order to ensure technically correct hand-
ling of Fahl tracheostomy tubes.
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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.
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.
Overlong tubes can be indicated particularly in cases of deep-seated tracheal stenoses.
Fahl LINGO tube variants are intended for tracheotomised patients who retain their larynx or for
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laryngectomees who use a shunt valve (voice prosthesis users).
III. WARNINGS
Patients must be trained by medical professionals on how to use the Fahl
tubes safely.
Fahl tracheostomy tubes must never be blocked, e.g. by mucus or encrustation.
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Blockage can cause asphyxiation!
Fahl tracheostomy tubes are reusable medical products intended for single-patient
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use.
Do not re-use with another patient. Do not reprocess for re-use by another patient.
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!
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 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.
CAUTION!
Modifications to the tracheostomy tube of any kind, in particular perforations as well
as repairs to the tube, may only be carried out by the manufacturer himself or by
companies expressly authorised for this in writing by the manufacturer! Inexpertly
performed work on tracheostomy tubes can lead to serious injuries.
IV. COMPLICATIONS
The following complications could emerge when using this device:
Contamination of the stoma may make it necessary to remove the tube. Contamina-
tions can furthermore cause infections that necessitate the use of antibiotics.
TRACHEOSTOMY TUBE
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tracheostomy tubes. the instructions for use serve
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EN
tracheostomy
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