13
EN
LARYNGOTEC
®
TRACHEOSTOMY TUBES
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.
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
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.
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
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
®
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.
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.
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
®
tracheostomy tubes, the products may become infected for instance with yeast
(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.
Use only auxiliary equipment with a 22 mm connection with Fahl
®
KOMBI adapters to prevent accidental
loss of accessories or damage to the tube.
We highly recommend always keeping at least two replacement tubes on hand to ensure continuous
supply.
Do not perform any type of adjustment, repair or alteration on a tracheostomy tube or compatible
accessories. If a product is damaged, it must be discarded immediately.
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