Service Life; Legal Notices - Fahl TRACHEOTEC Instrucciones De Uso

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 OPTI-
FLUID 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 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.
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 function-
al deficiencies, injuries, infections, and/or other complications or adverse events caused by unauthor-
ised 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 perfo-
rations, 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-Ve-
trieb 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 Mediz-
intechnik-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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