Service Life; Legal Notices - Fahl SPIRAFLEX Instrucciones De Uso

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.
Only use stoma oil (REF 31525) as lubricant, or OPTIFLUID stoma oil wipes (REF 31550).
EN ®
We highly recommend keeping at least two replacement tubes on hand to ensure continuous supply.
XII. 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 as well as repairs on the tube must 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.
XIII. 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 XII., 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.
SPIRAFLEX is a trademark and brand of Andreas Fahl Medizintechnik-Vertrieb GmbH, Cologne
®
registered in Germany and the EU member states.
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