Fahl 25900, Инструкция по эксплуатации

Страница: 12 / 56

12
EN
LARYVOX
®
INSERTER
1. FOREWORD
These instructions apply to LARYVOX
®
INSERTER (- EXPERT , - EXPERT
SMALL , - UNIEK , - SPECIAL ).
These instructions for use serve to inform the physician and medical pro -
fessional staff in order to ensure technically correct handling of LARYVOX
®
INSERTER s.
Please read the instructions for use carefully before using the product for
the first time!
Keep them in an easily accessible place for future reference.
Please keep the package for as long as you use the
LARYVOX
®
INSERTER .
It contains important information on the product!
2. SAFETY INFORMATION
N
WARNING!
The LARYVOX
®
INSERTER (-EXPERT, -EXPERT SMALL, -UNIEK, -SPE -
CIAL) is a single-patient product and is intended for one single use only.
N
WARNING!
Never use the LARYVOX
®
INSERTER (-EXPERT, -EXPERT SMALL,
-UNIEK, -SPECIAL) if the device exhibits visible deficiencies or defects.
Contact the manufacturer in such cases.
N
WARNING!
A damaged voice prosthesis must not be used.
N
WARNING!
The voice prosthesis must always be placed with care in the shunt
channel. Pay attention to the correct position of the voice prosthesis.
N
WARNING!
A LARYVOX
®
INSERTER (-EXPERT, -EXPERT SMALL, -UNIEK, -SPE -
CIAL) must not be cleaned or disinfected.
Sterilisation and reuse can impair the function and is therefore not per -
missible either.
CAUTION!
Please also observe the notes / warnings in the instructions for use provided
by the voice prosthesis manufacturer.
3. INTENDED PURPOSE
LARYVOX
®
INSERTER (- EXPERT , - EXPERT SMALL , - UNIEK , - SPE-
CIAL ) devices are use for the anterograde placement of a voice prosthesis
when replacing the voice prosthesis.
4. INDICATION
A voice prosthesis must not remain permanently in the shunt channel, but
needs to be replaced at regular intervals, depending on its proper functioning.
The leakage of fluids with the transfer of saliva or food particles from the
oesophagus to the trachea is a direct indication for an examination by the
physician and, where necessary, replacement of the voice prosthesis used.
The LARYVOX
®
INSERTER (- EXPERT , - EXPERT SMALL , - UNIEK , - SPE-
CIAL ) replacement is performed in patients who have been equipped with a
voice valve following removal of the larynx (laryngectomy).
5. CONTRAINDICATION
The use of the LARYVOX
®
INSERTER (- EXPERT , - EXPERT SMALL , - UN-
IEK , - SPECIAL ) for voice prosthesis placement in patients with increased
bleeding tendency, e.g. due to treatment with anticoagulants, must always
be weighed carefully on account of the risk.
Special caution is required in patients following radiation therapy and/or
chemotherapy, as there is an increased risk of puncture-induced complica-
tions due to possible tissue damage (e.g. scar tissue, fibroses and the like).
6. COMPLICATIONS AND ADVERSE REACTIONS
N
WARNING!
Inappropriate handling of the LARYVOX
®
INSERTER can cause materi -
al damage to the voice prosthesis.
CAUTION!
When the voice prosthesis is inserted, this can lead to irritations, coughing
or slight bleeding.
N
WARNING!
Should the voice prosthesis come loose from the shunt channel or
during insertion of the placement instrument, there is a risk of aspi -
ration.
In the event of aspiration, it must be attempted to expel the voice pros -
thesis through strong coughing.
If the voice prosthesis cannot be coughed out, it must immediately be
removed surgically.
Further complications:
• General discomfort due to manipulation on the shunt channel