Product Description - Fahl TRACHLINE Manual Del Usuario

CAUTION!
If there is strong secretion, a tendency to form granulation tissue, if the patient is un-
dergoing radiation therapy or if scabs have formed, a perforated cannula version is only
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recommended under regular surveillance by a doctor and provided that shorter replace-
ment 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 cuff for patients on
mechanical ventilation!
CAUTION!
Only use perforated/fenestrated cannula variants during artificial respiration after
consultation with the treating doctor/physician.
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.
When using Fahl tracheostomy tubes, the products may become infected for instance with
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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.
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.
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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.
VII. PRODUCT DESCRIPTION
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.
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Fahl tracheostomy tubes are reusable medical products intended for single-patient use.
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The package contains 1 tube, supplied sterile by ethylene oxide sterilization (EO).
The maximum period of use should not exceed 29 days.
MRT (MAGNETIC RESONANCE TOMOGRAPHY) INFORMATION
CAUTION!
Since the tracheostomy tubes with cuff have a small metal spring in the non-return valve
of the pilot balloon with inflation tube, the tracheostomy tube with cuff must not be used
while an MRI (magnetic resonance imaging) examination is being performed.
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