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
EN
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
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.
Use only auxiliary equipment with a 22 mm connection with Fahl
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.
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
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
Fahl
tracheostomy tubes are reusable medical products intended for single-patient use.
®
Fahl
tracheostomy tubes are only to be used by the same patient and not by another
®
patient.
The package contains 1 tube, supplied sterile by ethylene oxide sterilization (EO).
The maximum period of use is 29 days (reckoned form the date on which the sterile package
was opened). If a pathogenic microbe (e.g. MRSA) is present, the period of use/indwelling
time is reduced accordingly.
tracheostomy tubes are products that are made of a variety of medical-
®
tracheostomy tubes in various sizes and lengths.
®
20
tube
®
KOMBI adapters to
®