19
EN
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.
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.
V. CONTRAINDICATIONS
Do not use if the patient is allergic to the material.
CAUTION!
Never under any circumstances use cannula variants without low-pressure cuff for
patients on mechanical respiration!
CAUTION!
Only use perforated/fenestrated cannula variants during artificial respiration after
consultation with the treating doctor/physician.
CAUTION!
During mechanical ventilation, never under any circumstances use
DURATWIX
®
tube
versions without inner cannula that are equipped with a universal connector that can be
attached to the outer cannula by a rotating movement and is not permanently attached
to the outer cannula!
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.
In order to rule out accidental detachment of auxiliary equipment or damage to the tube, insert
only auxiliary equipment with a 15 mm connection into Fahl
®
UNI adapters.
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.
CAUTION!
When increased tensile forces occur during mechanical ventilation, e.g. due to stiff swivel
connectors connected to the tracheostomy tube or due to uncontrolled movements of
the patient, the inner cannula can be accidentally twisted out of the outer cannula. The
patient must therefore be monitored, or the tracheostomy tube and/or the tube system
must be replaced if necessary.
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.
CAUTION!
United States Federal law restricts this device to sale, distribution and use by or on order
of a physician or a licensed practitioner (in the US only).
VII. PRODUCT DESCRIPTION
The DURATWIX
®
tracheostomy tubes are products that are made of a variety of medical-grade
synthetic materials.
The tracheostomy tubes are made of thermosensitive medical synthetics that develop their
optimal product properties at body temperature.
We supply the Fahl
®
tracheostomy tubes in various sizes and lengths.