Fahl 25900, Инструкция по эксплуатации

Страница: 13 / 56

13
EN
• Expansion/dilatation of the shunt channel
•
Inflammatory reactions and formation of granulations in the region of the
shunt channel
7. PRODUCT DESCRIPTION
The LARYVOX
®
INSERTER (- EXPERT , - EXPERT SMALL , - UNIEK , - SPE-
CIAL ) consists of a placement instrument for the secure fixation of the
voice prosthesis for insertion with the applicator* (*with the exception of
LARYVOX
®
INSERTER SPECIAL ) into the shunt channel.
The LARYVOX
®
INSERTER is available in the variants - EXPERT , - EX-
PERT SMALL , - UNIEK , - SPECIAL .
Each variant has a distinct colour (see list) so that it can be clearly distin -
guished.
The inserter enables users of voice prostheses to apply a uniform placement
technique for the insertion of different types of voice prostheses.
NOTE:
In addition, also heed the instructions for use of the voice prosthesis used.
8. APPLICATION
8.1 BASIC PREPARATION
1. Prior to removing the voice prosthesis to be replaced, check its seating
in the shunt channel.
The correct length of the voice prosthesis is of essential importance for
avoiding complications such as peri-prosthetic leakage, pressure ne -
croses or the like.
2. It is recommended to use the BLOM-SINGER
®
SIZER DILATOR ( REF
BE2051 , BE2052 ) for checking the length of the shunt channel in order
to determine the correct length of the shunt channel prior to placement.
3. Check the packaging for damages and check the expiry date. Do not use
the product after expiry of this date, or if the packaging and/or the product
exhibit visible damages.
8.2 APPLICATION OF THE VARIANTS
The application of the various LARYVOX
®
INSERTERs is detailed for
each variant in the following. Please follow the relevant instructions:
8.2.1 LARYVOX
®
INSERTER REF 25900 (turquoise)
PLEASE NOTE!
The LARYVOX
®
INSERTER is used only and exclusively for the antero-
grade placement / replacement of a 20 or 22.5 French voice prosthesis, with
a shaft length of 5 mm or longer.
The
LARYVOX
®
INSERTER must not be used for placement of a
BLOM-SINGER
®
DUAL - VALVE INDWELLING device ( REF DV20XX-NS ,
REF DV20XX-LF ).
N
WARNING!
A voice prosthesis with a shaft length of less than 5 mm or with a dual
valve flap cannot be securely fixed in place with the LARYVOX
®
IN-
SERTER.
There is a risk that such a voice prosthesis may become detached from
the inserter and may cause acute respiratory distress.
8.2.2 LARYVOX
®
INSERTER EXPERT (REF 25910) (black)
PLEASE NOTE!
The LARYVOX
®
INSERTER EXPERT is used only and exclusively for the
anterograde placement of the following voice prostheses with a shaft length
of 5 mm or longer:
Voice prostheses with a diameter of 16 French, also BLOM-SINGER
®
DUAL VALVE INDWELLING (with dual valve flap) - BLOM-SINGER
®
DUAL VALVE INDWELLING 20 French
N
WARNING!
A voice prosthesis with a shaft length of less than 5 mm cannot be
securely fixed in place with the LARYVOX
®
INSERTER EXPERT. There
is a risk that such a voice prosthesis may become detached from the
inserter and may cause acute respiratory distress.
8.2.3 LARYVOX
®
INSERTER EXPERT SMALL (REF 25915) (yellow)
PLEASE NOTE!
The LARYVOX
®
INSERTER SMALL is used only and exclusively for the
anterograde placement / replacement of voice prostheses with a shaft length
of 4 mm, 16 French or 20 French.
N
WARNING!
A voice prosthesis with a shaft length of more than 4 mm cannot be se -
curely fixed in place with the LARYVOX
®
INSERTER SMALL.
There is a risk that such a voice prosthesis may become detached from
the inserter and may cause acute respiratory distress.