18
EN
I. FOREWORD
These instructions for use are valid for Fahl
®
tracheostomy tubes. The instructions for use serve
to inform 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.
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 act) and conform to, among others, the “Basic Requirements” as per Annex I of Directive
93/42 EEC.
II. INTENDED USE
Fahl
®
tracheostomy tubes are intended to stabilise the tracheostoma following laryngectomy
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
®
tracheostomy
tubes 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
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.
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 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.
CAUTION!
Tracheostomy tubes with speech function are only recommended for tracheotomised
patients with normal secretion and normal mucous tissue.
Tracheostomy tubes that contain metal parts must under no 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. In the case of plastic 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.
DURATWIX
®
TRACHEOSTOMY TUBE