Fahl SPIRAFLEX, Инструкция по эксплуатации

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27
EN
The outer cannula must be cleaned or the tracheostomy tube replaced after 1 week at the
latest though, since after that the risk of formation of granulation tissue or of tracheo -
malacia, etc. can increase significantly, depending on the patient‘s disease condition.
The outer cannula must only be cleaned with the cuff inflated, and the safety balloon must not
come into contact with the cleaning solution in order to prevent intrusion of cleaning solution into
the balloon, since this would lead to serious functional impairment and health risks for the user.
The outer cannula with cuff can be cleaned/rinsed with sterile saline solution.
A brush must not be used for tracheostomy tubes with cuff in order to avoid damaging the
balloon!
Damage to the balloon and hence a defect of the tracheostomy tube can only be avoided by
careful and gentle handling.
2. Chemical Disinfection Instructions
2.1 Disinfecting the inner cannula / cleaning the outer cannula without cuff
The Fahl
®
tracheostomy tube can be disinfected by cold disinfection with special chemical di -
sinfectants.
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. hos -
pitals, 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 could badly damage or even destroy the
tracheostomy tube.
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.
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
(also available in the USA). Always observe the area of application and spectrum of activity
specified for the disinfectant by the manufacturer.
After disinfection the tube must be rinsed inside and out very thoroughly with sterile saline
solution (NaCl 0.9%) and then dried.
SPIRAFLEX
®
/SPIRAFLEX
®
XL/SPIRAFLEX
®
MRT:
When doing this, the neck flange should be de-arrested and moved to and fro several times to
ensure thorough cleaning underneath the locking screw of the neck flange as well
Dry the tube thoroughly with a clean and lint-free cloth after wet cleaning.
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
(OPTIFLUID
®
Stoma Oil, 25 ml bottle REF 31525/ Stoma oil wipe REF 31550) or lubricant
gel (Fahl
®
OPTIFLUID
®
Lubricant Gel 20 g tube REF 36100/ 3 g sachet REF 36105).