Fahl TRACHEOSILC Manual Del Usuario página 14

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
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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 TRACHEOTEC SILC and TRACHEOSILC tracheostomy tubes are products which are made
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of medical-grade silicone.
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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Please see the size table in the appendix.
TRACHEOTEC SILC tracheostomy tubes have a high-pressure cuff. Please heed in this regard
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Section 3.1.2 on leakproofness testing of the cannula and high-pressure cuff.
TRACHEOSILC / TRACHEOTEC SILC Tracheostomy tubes are single-patient products and are
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intended for single use.
The package contains 1 tube, supplied sterile by ethylene oxide sterilization (EO).
The tube tip is rounded to prevent irritation of the mucus membranes in the trachea.
It may be advisable to use tubes of different lengths alternately so the tip of the tube does not always
touch the same spot in the trachea and cause irritation. This prevents pressure points or the formation
of granulation tissue. Always discuss the exact procedure with your doctor/physician.
MRT (Magnetic Resonance Tomography) INFORMATION
These tracheostomy tubes can even be worn by the patient during magnetic resonance tomography
(MRT).
This only applies to tracheostomy tubes without metal parts / without cuff.
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.
MRT is a diagnostic imaging technique in which inner organs, tissues and joints are depicted with the
help of magnetic fields and radio waves. Metallic objects can be drawn into the magnetic field and can
induce changes by their acceleration. Although the metal spring is extremely small and lightweight,
interactions that could give rise to health impairments or to malfunction or damage of the technical
equipment used or of the tracheostomy tube itself nevertheless cannot be ruled out in this context.
If wearing a tracheostomy tube is indicated for keeping the tracheostoma open, we recommend use
of a metal-free tracheostomy tube instead of the tracheostomy tube with cuff while an MRT is being
performed.
CAUTION!
Do not use a tracheostomy tube with cuff while a nuclear magnetic imaging / MRI examination
is being performed!
1. Neck flange
A particular feature of the Fahl tracheostomy tube is the specially shaped neck flange, which is
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designed to fit the anatomy of the neck.
The size specifications are printed on the neck flange.
The neck flange of the tracheostomy tubes has two side eyelets for inserting a tube holder.
All Fahl tracheostomy tubes with fastening eyelets include a disposable tube holder. The tube holder
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secures the tracheostomy tube to the neck.
Please follow the instructions provided with the tube holder carefully when attaching and removing it
from your tracheostomy tube.
The insertion aid (obturator) included in delivery facilitates insertion of the tracheostomy tube.
Ensure that the Fahl tracheostomy tube is placed in the tracheostoma without tension and the position
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is not changed when fastening the tube holder.
2. Connectors and adapters
Connectors and adapters are used to connect compatible tube accessories.
The options available to a patient depend on the clinical condition, such as status post laryngectomy
or tracheostomy.
Connectors/adapters are normally permanently attached to the inner cannula. The connector in this
case is the universal (15 mm) connector with the aid of which so-called artificial noses or heat and
moisture exchangers (HMEs, filters for exchanging heat and moisture) can be attached.
A 15 mm standard connector enables secure connection to required accessories.
3. Cannula tube
The cannula tube borders directly on the neck flange and directs the airflow into the trachea.
The tube tip is rounded to prevent irritation of the mucus membranes in the trachea.
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