Intended Use; Contraindications; Device Description; English - Atos Medical PROVOX LaryTybe Handbuch

The manual, which accompanies this product, may
be revised from time to time and must therefore
be reviewed prior to each procedure in which the
product is used.

Intended use

The Provox LaryTube Sizer Kit is intended for
use by the prescribing clinician to determine the
size(s) of LaryTube that should be prescribed to
the laryngectomized patient.
The Sizer Kit should be used only by a
prescribing clinician who has read the LaryTube
Manual. A copy of that manual comes with the
Sizer Kit. It can also be viewed on the Internet at
www.atosmedical.com.
The Sizer LaryTubes are intended for the sizing
procedure only. After the correct size(s) have been
determined, a new LaryTube(s) shall be prescribed
to the patient for actual use. LaryTube order
information is found on the last page of this manual.

Contraindications

The Sizer Kit in itself does not have specific
contraindications.
The Provox LaryTubes contained in the LaryTube
Sizer Kit are not intended for patients requiring
mechanical ventilation.

Device description

The Sizer Kit is a box which contains samples
("Sizers") of a variety of commercially available
Provox LaryTubes. The sizes of these Sizers and
actual Provox LaryTubes are the same. The size is
indicated on the products and both diameter and
length are indicated on the chart inside the box.
Each Sizer in the Sizer Kit is stored in an
individual removable polypropylene box. This
makes it possible for the prescribing specialist
to remove the individual storage boxes with the
Sizers from the outer storage box individually. This
allows for hygienic handling of both the Sizers and
the storage boxes.
After each sizing session, the Sizer(s) with
its individual storage box(es) must be cleaned,
disinfected, dried and steam sterilized according
to the accompanying "Instructions for cleaning
and sterilization". The outer storage box must also
be cleaned if contaminated. The Sizer LaryTubes
and their individual removable storage boxes are
thereafter put back at the appropriate position as
indicated in the bottom of the outer storage box.

ENGLISH

WARNINGS
• TO AVOID THE TRANSFER OF DISEASE,
NEVER USE A CONTAMINATED SIZER
LARYTUBE.
After using a Sizer LaryTube, it becomes
contaminated through handling and contact
with the patient's stoma. To avoid the transfer
of disease from one patient to another, use
appropriate hygienic procedures and do not put
the LaryTube and its individual storage box
back in the outer storage box after use. Make
sure that each used Sizer and individual storage
box are cleaned, disinfected, dried and steam
sterilized. The outer storage box must also be
cleaned if contaminated.
• The Sizer LaryTubes are intended for the sizing
procedure only. After the correct size(s) have
been determined, new LaryTube(s) shall be
used by the patient.
PRECAUTIONS
• To reduce risks of causing damage to the
tracheostoma during the Sizing procedure:
• Thoroughly read the LaryTube Manual
before using the LaryTube Sizer Kit in order
to understand the Warnings, Precautions and
Instructions for use of the LaryTube during
insertion and replacement.
• Insert and remove the Provox LaryTube with
caution, never use force.
• Only use water-soluble lubricants. Oil-based
lubricants (e.g., Vaseline) may weaken, damage
or destroy the product and shall not be used.
• The Sizers and the individual storage boxes are
designed to withstand 10 cleaning and steam
sterilization procedures at 137°C/278°F for
3 minutes or at 134°C/273°F for 18 minutes.
Always ensure mechanical integrity before
each use.
• The outer storage box is not designed to
withstand any steam sterilization.
• Make sure that no silicone residues are left in
the holes or the lumen of the LaryTube after
fenestration.
• If the patient is using a voice prosthesis, be
careful during insertion of the LaryTube. You
may accidentally dislodge the voice prosthesis,
which could lead to aspiration of the prosthesis.
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