6
EN
FR
V. COMPLICATIONS
If the particle filter is clogged or if signs of clogging appear, the LARYVOX
®
EXTRA HME
filter cassette must immediately be removed and disposed of.
VI. PRECAUTIONS
Care must be taken to ensure that the valve opening is not blocked by clothing or the like in
order to enable unhindered breathing (risk of respiratory distress).
VII. CONTRAINDICATIONS
• The LARYVOX
®
EXTRA HME should be removed if respiratory resistance is too high.
•
Use in patients with strong exsiccosis (dehydration), or excessive secretion in the lungs and
airways, or strong air leakage flow (exhaled air not flowing through the filter cassette) is not
permissible.
•
Not for use in patients with impaired consciousness and/or in non-independent persons
requiring the help of others, who are not able to remove the LARYVOX
®
EXTRA HME filter
cassette by themselves in emergency situations.
VIII. INSTRUCTIONS
•
Check whether the packaging and the product are in a faultless condition.
•
Check the use-by or expiry date. Do not use after this date.
•
Press the speaking button down in order to check whether it is fully functional (➌a). When the
speaking button is released, it immediately returns to the open starting position (➌b).
•
Fit ➍ the LARYVOX
®
EXTRA HME filter cassettes vertically onto the 22-mm connection of the
tracheostomy tube or base plate, exerting gentle pressure.
•
Check the respiratory resistance.
•
For speaking, press the speaking button ➎ down slightly with your finger so as to enable
phonation by means of the closure.
•
When the speaking button is released, it immediately returns to its open breathing position
(starting position) ➏.
• Remove the LARYVOX
®
EXTRA HME filter cassettes after a ➐ wearing period of 24 hours at
most, or if the filter cassette is contaminated with secretions for instance. To do this, hold the
base plate or the tracheostomy tube in position with two fingers ➑ and remove the filter cassette
by tilting it downward slightly.
IX. SERVICE LIFE
The maximum period of use / wearing period is 24 hours.
The filter must be changed even several times a day if required, for instance if the respiratory
resistance is in danger of increasing due to accumulation of secretions.
X. LEGAL NOTICES
The manufacturer Andreas Fahl Medizintechnik-Vertrieb GmbH accepts no liability for damage
caused by unauthorised product modifications, repairs not carried out by the manufacturer or
by improper handling, care (cleaning/disinfection) and/or storage of the products contrary to the
provisions of these instructions for use.
Should a serious adverse event occur in connection with this product of Andreas Fahl
Medizintechnik-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.
Product specifications described herein are subject to change without notice.
LARYVOX
®
is a trademark and brand of Andreas Fahl Medizintechnik-Vertrieb GmbH, Cologne
registered in Germany and the EU member states.
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