Service Life; Legal Notices - Fahl TRACHLINE Manual Del Usuario

2.2 Disinfecting the outer cannula with cuff
Tracheostomy tubes with cuff may only be disinfected provided that this is performed and
checked with utmost care. The balloon must always be inflated beforehand.
EN
Disinfection steps
For this purpose, OPTICIT tube disinfectant (REF 31180) should be used in accordance
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with the manufacturer's instructions. As alternative, we recommend a disinfectant based on
glutaric aldehyde as active ingredient. Always observe the area of application and spectrum
of activity specified for the disinfectant by the manufacturer."
Follow the instructions for the disinfectant.
Dry the tube thoroughly with a clean and lint-free cloth after wet cleaning.
3. Sterilisation/Autoclaving
Resterilisation is not allowed.
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 sto-
rage.
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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We highly recommend keeping at least two replacement tubes on hand to ensure conti-
nuous 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.
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 manu-
facturer 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-compli-
ance 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.
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.
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