Intended Use - Fahl SPIRAFLEX Instrucciones De Uso

SPIRAFLEX
I. FOREWORD
These instructions for use are valid for Fahl
inform the physician, nursing staff and patient/user in order to ensure technically correct handling 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!
The Fahl tracheostomy tubes are medical devices as defined by the MPG (German medical devices
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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 or
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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.
Tracheostomy tubes with adjustable neck flange enable individual patient-specific adaptation of
the tube, particularly in obese patients and in situations with post-operative oedemas or collapsed
tracheostoma.
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.
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
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.
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.
CAUTION!
Tracheostomy tubes with speech function are only recommended for tracheotomised patients
with normal secretion and normal mucous tissue.
CAUTION!
Tracheostomy tubes that contain metal parts (SPIRAFLEX
circumstances be used during a radiation therapy (radiotherapy), as this can lead to serious
skin damage! If you need to wear a tracheostomy tube during a radiation therapy, then only use
plastic tracheostomy tubes without any metal parts (SPIRAFLEX
tracheostomy tubes with silver speaking valve, the valve can for instance be removed completely
from the tube, including the safety chain, by removing the inner cannula from the outer cannula
before starting a radiation therapy.
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 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.
TRACHEOSTOMY TUBES
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tracheostomy tubes. The instructions for use serve to
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tracheostomy tubes
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tracheostomy tubes
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/ SPIRAFLEX XL) must under no
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MRT). In the case of plastic
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