Service Life; Legal Notices - Fahl PHONTRACH Manual De Instrucciones

3. Sterilisation / Autoclaving
Steam sterilisation: Sterilise the tracheostomy tube with saturated steam either at 134
degrees Celsius/273.2 degrees Fahrenheit for at least 5 minutes, or at 121 degrees
Celsius/249.8 degrees Fahrenheit for at least 15 minutes.
In tracheostomy tubes with speaking valve, the speaking valve must first be detached.
Steam sterilisation must be performed in compliance with the respective currently valid
national standards. In particular, the instructions in the ANSI/AAMI ST46:2002 standard
Steam sterilization and sterility assurance in health care facilities must be observed.
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.
We highly recommend keeping at least two replacement tubes on hand to ensure continuous
supply.
XI. SERVICE LIFE
These tracheostomy tubes are products intended for single-patient use.
PHONTRACH tracheostomy tubes have an expected service life of three to six months
®
after the packaging has been opened.
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 tubes must be replaced at the latest after 12 months of use or 12 months
after the packaging has been opened - if damaged or the like, they must be replaced
immediately though - the tracheostomy tubes must not be used any longer and must be
disposed of correctly.
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.
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.
PHONTRACH is a trademark and brand of Andreas Fahl Medizintechnik-Vertrieb GmbH,
®
Cologne registered in Germany and the EU member states.
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