V. CONTRAINDICATIONS
Do not use if the patient is allergic to the material.
CAUTION!
EN
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!
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.
We highly recommend always keeping at least two replacement tubes on hand to ensure continuous
supply.
CAUTION!
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 SPIRAFLEX
tube reinforced with a metal spiral).
The SPIRAFLEX
reinforced with a plastic spiral).
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.
The dimensional stability of the tube is ensured by the spiral in the wall of the soft tube material.
The variable length adjustment of the external section of the tracheostomy tube by means of the
height-adjustable neck flange with screw attachment as well as the anatomically optimised bend angle
of the highly flexible, spiral-reinforced cannula tube facilitate adaptation to the shape of the trachea and
guarantee high wearing comfort as well as tension-free seating in the tracheostoma.
The position of the neck flange can be easily documented and reproduced by means of an imprinted
scale with 10 mm graduations extending over a length of 5 cm.
Please see the size table in the appendix.
A particular feature of the Fahl
The tube tip is rounded to prevent irritation of the mucus membranes in the trachea.
There are two lateral fastening eyelets on the neck flange for attaching a tube holder.
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
CAUTION!
The SPIRAFLEX
resonance tomography (MRT).
CAUTION!
The SPIRAFLEX
used during a magnetic resonance tomography (MRT) examination.
1. Neck flange
A particular feature of the Fahl
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.
The insertion aid included in delivery facilitates insertion of the tracheostomy tube.
/ SPIRAFLEX
XL tracheostomy tubes are products that are made of PVC (cannula
®
®
MRT tracheostomy tubes are products that are made of PVC (cannula tube
®
tracheostomy tubes in various sizes and lengths.
®
tracheostomy tubes is the specially shaped neck flange.
®
MRT tracheostomy tubes can even be worn by the patient during magnetic
®
/ SPIRAFLEX
XL tracheostomy tubes must never under any circumstances be
®
®
tracheostomy tube is the specially shaped neck flange, which is
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