Service Life; Legal Notices - Fahl TRACHEOTEC Gebrauchsanweisung

Follow the instructions for the disinfectant.
Thoroughly rinse the tube or button under lukewarm running water or sterile saline solution (0.9%
NaCl solution).
Dry the tube thoroughly with a clean and lint-free cloth after wet cleaning.
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3. Sterilisation/Autoclaving
Resterilisation is not allowed.
CAUTION!
Heating to over 65°C, disinfection with boiling water or steam sterilisation are not allowed and
lead to damage of the tracheostomy tube.
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 OPTIF-
LUID stoma oil wipe.
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Only use stoma oil (REF 31525) as lubricant, or OPTIFLUID stoma oil wipes (REF 31550).
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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 should not exceed 29 days.
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.
Never under any circumstances continue using damaged tracheostomy tubes.
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 functio-
nal deficiencies, injuries, infections, and/or other complications or adverse events caused by unauthori-
sed product alterations or improper use, care, and/or handling.
In particular, Andreas Fahl Medizintechnik-Vertrieb GmbH will not accept any liability for damages cau-
sed 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 inst-
ructions 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.
TRACHEOTEC is a trademark and brand of Andreas Fahl Medizintechnik-Vertrieb GmbH, Cologne
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registered in Germany and the EU member states.
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