Service Life; Legal Notices - Fahl DURATWIX JUNIOR Manual Del Usuario

Before the air is removed from the balloon by means of a syringe and the tracheostomy tube
is withdrawn, the region of the trachea above the balloon must first be cleaned by suctioning
off secretions and mucus. If the patient is responsive and reflexes are intact, it is recommen-
EN
ded that the patient be suctioned while at the same time unblocking the tracheostomy tube.
Suctioning is performed by inserting a suction catheter through the cannula tube into the
trachea. In this way, suctioning can be performed without any problems and gently for the
patient and cough stimulus and the risk of aspiration are minimised.
Then deflate the cuff while suctioning at same time.
Proceed very carefully to avoid injury to the mucus membranes.
Step-by-step instructions to remove the Fahl tracheostomy tubes:
®
The tracheostomy tubes should be removed with the head slightly tilted back. Grip the tube
at the side by the neck flange or the housing (see picture 7).
Carefully remove the tracheostomy tubes.
X. STORAGE/CARE
Still sterile packed replacement tubes should be stored in a dry environment away from
dust, sunlight and heat.
We highly recommend keeping at least two replacement tubes on hand to ensure conti-
nuous supply.
XI. SERVICE LIFE
These tracheostomy tubes are sterile products for single-patient use.
The maximum period of use should not exceed 29 days.
The service life of a tube is influenced by many factors. The composition of the secretions
and other aspects, for example, are very important.
Damaged tubes must be replaced immediately.
CAUTION!
Modifications to the tracheostomy tube of any kind, in particular perforations as well
as repairs to the tube, may only be carried out by the manufacturer himself or by
companies expressly authorised for this in writing by the manufacturer! Inexpertly
performed work on tracheostomy tubes can lead to serious injuries.
XII. LEGAL NOTICES
The manufacturer Andreas Fahl Medizintechnik-Vertrieb GmbH will not accept any liability
for functional deficiencies, injuries, infections, and/or other complications or adverse events
caused by unauthorised product alterations or improper use, care, and/or handling.
In particular, Andreas Fahl Medizintechnik-Vertrieb GmbH will not accept any liability for
damages caused by modifications to the tracheostomy tube, especially due to shortening of
the same or perforations, if these modifications or repairs were not carried out by the manu-
facturer himself. This applies both to damages to the tubes themselves caused thereby and
to any consequential damages caused thereby.
If the tracheostomy tube is used beyond the period of use specified under Section XI, and/or
if the tracheostomy tube is used, maintained (cleaned, disinfected) or stored in non-compli-
ance with the instructions and specifications laid down in these instructions for use, Andreas
Fahl Medizintechnik-Vetrieb GmbH will, as far as legally permissible, be free of any liability,
including liability for defects.
Should a serious adverse event occur in connection with this product of Andreas Fahl Me-
dizintechnik-Vertrieb GmbH, this is to be reported to the manufacturer and the competent
authority of the Member State in which the user and/or patient are domiciled.
Sale and delivery of all Andreas Fahl Medizintechnik-Vertrieb GmbH products is carried out
exclusively in accordance with our General Terms and Conditions of Business which can be
obtained directly from Andreas Fahl Medizintechnik-Vertrieb GmbH.
Product specifications described herein are subject to change without notice.
DURATWIX is a trademark and brand of Andreas Fahl Medizintechnik-Vertrieb GmbH, Co-
®
logne registered in Germany and the EU member states.
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