Fahl LARYNGOTEC, Instructions For Use Manual

Page: 17 / 184

17
EN
If necessary, for example, if persistent secretion residues cannot be removed by the cleaning bath,
additional cleaning with a special cannula-cleaning brush (OPTIBRUSH
®
, REF 31850 or OPTIBRUSH
®
Plus with fibre top, REF 31855) may help. Only use the cleaning brush, if the tube is removed and already
outside the tracheostoma.
Always insert the cannula cleaning brush into the cannula from the cannula tip (see picture 11).
Use the brush as directed and proceed with great care to avoid damage to the soft tube material.
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.
Never use tracheostomy tubes with impaired functionality or with damages such as sharp edges or
cracks, because this may lead to injuries of the mucus membranes in the trachea. If damages are found,
discard the tube.
2. Chemical Disinfection Instructions
The Fahl
®
tracheostomy tube can be disinfected by cold disinfection with special chemical disinfectants.
Disinfection should always be done if ordered by a doctor/physician due to specific health concerns
caused by disease, infection, or your specific situation.
Disinfecting is generally indicated to prevent cross-infection and in inpatient situations (e.g. hospitals,
nursing homes, and/or other health care facilities) to limit infections.
CAUTION
Always clean according to the cleaning procedure described above before proceeding to
disinfection (if applicable).
Disinfectants that release chlorine or that contain strong alkalis or phenol derivatives must under
no circumstances be used. This may seriously damage or even destroy the tube or button.
Disinfection steps
For this purpose, OPTICIT
®
tube disinfectant (REF 31180) should be used in accordance 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
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 the case of 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
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.
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 6 months.
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.