Service Life; Legal Notices - Fahl Duratwix Mode D'emploi

CAUTION!
Heating to over 65°C, disinfection with boiling water or steam sterilisation are not
allowed and lead to damage of the tracheostomy tube.
EN
X. STORAGE/CARE
Currently not used and cleaned tubes should be stored in a clean plastic container, dry
environment away from dust, sunlight and heat.
Still sterile packed replacement tubes should be stored in a dry environment away from
dust, sunlight and heat.
After cleaning tracheostomy tubes, make sure that the balloon has been deflated for storage.
After the inner cannula has been cleaned, disinfected if necessary and then dried, the
outer surface of the inner cannula should be lubricated by applying stoma oil, e.g.
using an OPTIFLUID stoma oil wipe.
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Only use stoma oil (REF 31500) as lubricant, or OPTIFLUID stoma oil wipes (REF
®
31550).
We highly recommend keeping at least two replacement tubes on hand to ensure continuous
supply.
XI. SERVICE LIFE
These tracheostomy tubes are sterile products for single-patient use.
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 service life of a tube is influenced by many factors. The composition of the secretions,
the quality of cleaning and other aspects, for example, are very important.
The maximum service life is not extended by using the tube intermittently (e.g. alternately
with other tubes at normal cleaning intervals).
The tracheostomy tube must be replaced at the latest 29 days after opening the sterile
package.
This applies regardless of whether the tube was used every day, only on some days or
not at all after the package was opened. After expiry of the 29-day period of use, the tubes
must not be used anymore but must be disposed of correctly. 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
manufacturer 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-
compliance 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.
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,
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Cologne registered in Germany and the EU member states.
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