Fahl BIESALSKI, Instructions For Use Manual

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12
EN
FAHL
®
BIESALSKI TRACHEOSTOMY TUBE
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.
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.
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.
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.
Unintentional Inhalation of a tube that was not sized correctly may need to be removed by
a doctor/physician.
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.
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.
If mucus blocks the tube it should be removed and cleaned.
V. CONTRAINDICATIONS
Do not use if the patient is allergic to the material.
CAUTION!
Tracheostomy tubes with speaking valves must not be used on any account by
laryngectomised patients, as this could lead to serious complications, even suffocation!
VI. PRECAUTIONS
The correct tracheostomy tube size should be selected by the treating physician or by trained
medical professionals.