Fahl LARYVOX INSERTER Instrucciones De Uso página 7

PIKTOGRAM-LEGEND
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Catalogue number
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Batch code
P
Consult instructions for use
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Use by
6
Keep away from sunlight
7
Keep dry
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Do not reuse
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Content (in pieces)
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Manufacturer
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non-sterile
LARYVOX
I. FOREWORD
These instructions for use are valid for the LARYVOX
instructions for use serve to inform the physician and medical professional
staff in order to ensure technically correct handling.
Please read the instructions for use carefully before using the product
for the first time!
II. INTENDED USE
The LARYVOX INSERTER is used for the anterograde placement / re-
®
placement of a shunt valve.
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 examination by the phy-
sician and the possible necessary replacement of the shunt valve used.
Using the LARYVOX
placement instrument and introduced into the existing shunt channel/fistula
with the corresponding applicator.
III. WARNINGS
Der LARYVOX INSERTER is a single-patient product and is intended
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only for one single use.
The LARYVOX INSERTER must not be cleaned or disinfected. Ste-
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rilisation and reuse can impair the function and is therefore also not
permissible.
The LARYVOX INSERTER was developed exclusively for the place-
®
ment 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 chan-
nel/fistula. Pay attention to the correct position of the shunt valve.
A damaged LARYVOX
not be used.
IV. COMPLICATIONS
Inappropriate handling of the LARYVOX
rial damage to the shunt valve.
When the shunt valve is inserted, this can lead to irritations, coughing
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 medical means.
Further complications:
• General feeling of discomfort due to stimulation of the shunt chan-
nel/fistula
• Expansion/dilation of the shunt channel/fistula
• Inflammatory reactions as well as forming of granulation in the
area of the shunt channel/fistula
• Dysphagia and difficulties in swallowing
• Candida colonisation
• Swallowing of the shunt valve
V. PRODUCT DESCRIPTION
The LARYVOX INSERTER consists of a placement instrument ➀ for the
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secure fixation of the shunt valve for insertion with the applicator ② into
the fistula channel.
The LARYVOX INSERTER offers users of shunt valves the option of a
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standardised placement technique for various types of shunt valves.
INSERTER
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INSERTER, a shunt valve can be attached firmly to a
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INSERTER or a damaged shunt valve must
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INSERTER. These
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INSERTER can cause mate-
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EN