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Verfügbare Sprachen
Verfügbare Sprachen
I. FOREWORD
These instructions for use are valid for the LARYVOX
EXPERT SMALL. These instructions for use serve to inform the
physician and medical professional staff in order to ensure techni-
EN
cally correct handling.
Please read the instructions for use carefully before using the
product for the first time!
II. INTENDED USE
The LARYVOX
terograde placement / replacement of a shunt valve with a shaft
length of 4 mm.
A shunt valve may not remain permanently in the shunt channel/
fistula, but needs to be replaced at regular intervals depending on
its functional efficiency.
The leakage of fluids with the transfer of saliva or food particles
from the oesophagus to the trachea is a direct indication for exami-
nation by the physician and the possible necessary replacement of
the shunt valve used.
Using the LARYVOX
can be attached firmly to a placement instrument and introduced
into the existing shunt channel/fistula with the corresponding ap-
plicator.
III. WARNINGS
LARYVOX
product and is intended only for one single use.
The LARYVOX
ned or disinfected. Sterilisation and reuse can impair the func-
tion and is therefore also not permissible.
The LARYVOX
exclusively for the placement of shunt valves.
Please also observe the notes / warnings in the instructions
for use for the shunt valve of the respective manufacturers.
The shunt valve must always be placed with care in the shunt
channel/fistula. Pay attention to the correct position of the
shunt valve.
A damaged LARYVOX
ged shunt valve must not be used.
IV. COMPLICATIONS
Inappropriate handling of the LARYVOX
material damage to the shunt valve.
When the shunt valve is inserted, this can lead to irritations, coug-
hing or slight bleeding.
Should the shunt valve become loose in the shunt channel/fistula,
there is a risk of aspiration. In the case of aspiration, try to expel
the shunt valve through strong coughing. If the shunt valve cannot
be coughed out, this must immediately be removed by professional
medical means.
Further complications:
-
General feeling of discomfort due to stimulation of the shunt
channel/fistula
-
Expansion/dilation of the shunt channel/fistula
V. PRODUCT DESCRIPTION
The LARYVOX
cement instrument ➊ for the secure fixation of the shunt valve for
insertion with the applicator ➋ into the shunt channel/fistula.
The LARYVOX
valves the option of a standardised placement technique for vari-
ous types of shunt valves.
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 importance for avoiding complications such as peri-prosthe-
tic 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.
1.
Mount the shunt valve with the tracheal flange on the head of
the placement instrument ➌.
2.
Fixate the safety thread of the shunt valve to the placement
instrument
purpose in the instructions for use of the manufacturer of the
shunt valve.
3.
Check the secure fit of the shunt valve on the placement ins-
trument.
4.
Press the oesophageal flange together forwards with the
thumb and index finger of one hand
flange forwards by approx. 1 cm with the placement instrument
into the slotted opening of the applicator
5.
Press on the oesophageal flange with the thumb of the other
hand. Use the thumb to pull it through the circular opening at
the end of the applicator folded forwards
to push the shunt valve further into the applicator at the same
time
6.
The marker positions 1 and 2 are displayed on the placement
instrument. Now guide the placement instrument with the shunt
valve through the applicator up to the line of marker position
1
INSERTER EXPERT SMALL is used for the an-
®
®
INSERTER EXPERT SMALL is a single-patient
®
INSERTER EXPERT SMALL must not be clea-
®
INSERTER EXPERT SMALL was developed
®
INSERTER EXPERT SMALL consists of a pla-
®
INSERTER EXPERT SMALL offers users of shunt
®
. You can find the information necessary for this
❹
.
❽
.
❾
INSERTER EXPERT SMALL, a shunt valve
INSERTER EXPERT SMALL or a dama-
®
6
INSERTER
®
INSERTER can cause
®
. Push the oesophageal
❺
.
❻
. Use the other hand
❼
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