Fahl LARYVOX PLUG 25800 Instrucciones De Uso página 8

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I. FOREWORD
These instructions for use are valid for the LARYVOX
ling plug. These instructions for use serve to inform the physician,
medical professional staff and user in order to ensure technically
correct handling.
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.
II. INTENDED USE
The LARYVOX
a defective shunt valve to prevent transprosthetic fluid leakage (cent-
rally through the shunt valve).
The LARYVOX
rod (①b).
When used for the first time the products must only be selected,
used and inserted by clinicians or medical professionals trained in
their use.
III. WARNINGS
Patients must be trained by medical professionals on how to
use the LARYVOX
The LARYVOX
only used for the transient sealing of a defective shunt valve. It
is not a permanent replacement for a functioning shunt valve.
Please consult a specialist as soon as possible to have the
shunt valve professionally examined and replaced if necessary.
LARYVOX
exclusively for use in a single patient.
Re-use of any kind in other patients and thus also reconditio-
ning for re-use in other patients is not allowed.
Only clean the LARYVOX
by the manufacturer.
The LARYVOX
ding to the cleaning instructions (see Section IX. CLEANING).
Sterilisation of the LARYVOX
The safety strap on the LARYVOX
or removed under any circumstances.
Never force the LARYVOX
shunt valve. There is a risk that the shunt valve may be pushed/
displaced into the oesophagus. In this case, a physician must
be consulted immediately.
Please also refer to the instructions for use of the shunt valve
you are currently using.
IV. COMPLICATIONS
If there are signs of shunt valve leakage or LARYVOX
malfunction, a physician should be consulted as soon as possi-
ble to check the sealing plug and the shunt valve.
V. CONTRAINDICATIONS
Do not use if the patient is allergic to the material.
The LARYVOX
valve.
CAUTION!
No tracheostoma accessories (e.g. HME filter cassettes, base
plates, tracheostomy tubes) may be used while using the
LARYVOX
position of the shunt valve/LARYVOX
tion (inhalation) into the lungs.
Catalogue number
Batch code
Use by
Single patient use
Consult instructions for use
Content (in pieces)
Keep dry
Keep away from sunlight
Manufacturer
PLUG sealing plug serves for the transient use with
®
PLUG (①a) is supplied non-sterile with an insertion
®
PLUG safely.
®
PLUG is not intended for permanent use and is
®
PLUG is a single-patient product and thus intended
®
®
PLUG must be cleaned after each use accor-
®
PLUG must not be used with a 4mm size shunt
®
PLUG. Use could result in an accidental change of
®
PLUG with cleaning agents approved
PLUG is not possible.
®
PLUG must not be changed
®
PLUG or insert it too deeply into the
®
PLUG and cause aspira-
®
8
PLUG sea-
®
PLUG
®