Fahl LARYVOX INSERTER Instrucciones De Uso página 8

EN
VI. INSTRUCTIONS
Prior to removing the shunt valve to be replaced, check its fit in the shunt
channel/fistula. The correct position of the shunt valve is of major import-
ance for avoiding complications such as peri-prosthetic leakage, pressure
necrosis or similar.
It is recommended to use a special measuring instrument to check the
length of the shunt channel/fistula to determine the correct shunt channel
length/fistula length before placement.
ATTENTION
Never use the LARYVOX INSERTER if it displays visible deficiencies
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or faults. Contact the manufacturer in such cases.
Mount the shunt valve with the tracheal flange on the head of the placement
instrument ③.
Fixate the safety thread of the shunt valve to the intended position ④.
Choose position B, if there is an opening on the safety thread of the shunt
valve ⑤. Otherwise choose positions A or C ⑥ to fixate the shunt valve in a
vertical position. You can find the information necessary for this purpose in
the instructions for use of the manufacturer of the shunt valve.
Check the secure fit of the shunt valve on the placement instrument.
Press the oesophageal flange together forwards with the thumb and index
finger of one hand ⑦. Push the oesophageal flange forwards by approx. 1
cm with the placement instrument into the slotted opening of the applica-
tor ⑧.
And press on the oesophageal flange with the thumb of the other hand.
Pull this through the slotted opening of the applicator folded forwards with
the thumb ⑩. Use the other hand to push the shunt valve further into the
applicator at the same time ⑩.
The marker positions 1 and 2 are displayed on the placement instrument.
Now guide the placement instrument with the shunt valve through the ap-
plicator up to the line of marker position 1 ⑪.
The shunt valve can now be introduced into the shunt channel/fistula with
the applicator.
Guide the tip of the applicator carefully up to ¾ into the shunt channel/
fistula ⑫.
Now push the shunt valve slowly forwards through the applicator up to the
line of marker position 2. The oesophageal flange will open at the lumen
of the oesophagus ⑬.
Now retract the applicator carefully via the placement instrument. The tra-
cheal flange will open in the lumen of the trachea. The applicator can be
retracted via the placement instrument ⑭.
Check the correct position of the shunt valve by rotating the shunt valve
with the placement instrument by pulling slightly ⑮.
If the shunt valve is in the correct position, the safety thread is severed ⑯.
VII. PERIOD OF USE
The LARYVOX INSERTER is intended for single use.
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VIII. GENERAL TERMS AND CONDITIONS
The manufacturer Andreas Fahl Medizintechnik-Vertrieb GmbH will not ac-
cept any liability for functional deficiencies, injuries, infections, and/or other
complications or adverse events caused by unauthorised product alterati-
ons 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 LARYVOX IN-
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SERTER or by repairs, if these modifications or repairs were not carried out
by the manufacturer himself. This applies both to damages to the LARY-
VOX INSERTER itself caused thereby and to any consequential damages
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caused thereby.
If the LARYVOX INSERTER is used beyond the period of use specified
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under Section VII, and/or if the LARYVOX INSERTER is used, maintained
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(cleaned, disinfected) or stored in non-compliance with the instructions and
specifications laid down in these instructions for use, Andreas Fahl Medi-
zintechnik-Vetrieb GmbH will, as far as legally permissible, be free of any
liability, including liability for defects.
Sale and delivery of all Andreas Fahl Medizintechnik-Vertrieb GmbH pro-
ducts 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. The manufacturer reserves the right to
make changes to the product at any time without notice.
LARYVOX INSERTER is a trademark and brand of Andreas Fahl Me-
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dizintechnik-Vertrieb GmbH, Cologne registered in Germany and the EU
member states.
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