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ENGLISH
Intended use
The Provox®LaryButton™ Sizer Kit is intended
for use by the prescribing clinician to determine
the size(s) of LaryButton that should be prescribed
to the patient.
The Sizer Kit should be used only by a
prescribing clinician who has read the LaryButton
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 LaryButtons are intended for the
sizing procedure only. After the correct size(s)
have been determined a new LaryButton(s)
shall be prescribed to the patient for actual use.
LaryButton order information is found on the last
page of this manual.
Contraindications
The Sizer Kit in itself does not have specific
contraindications.
Do not use the Provox LaryButton, or use it only
with special care, in cases of tracheostoma tissue
problems such as damaged mucous membrane,
granulation tissue formation, and vulnerability
with a higher tendency to bleed.
The Provox LaryButton may be contraindicated
for patients with bleeding disorders or undergoing
anticoagulant treatment.
Device description
The Sizer Kit is a box which contains samples
(“Sizers”) of commercially available Provox
LaryButtons. The sizes of these Sizers and actual
Provox LaryButtons are the same and are indicated
on the products themselves and in the bottom of
the outer storage 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 LaryButtons
and their individual removable storage boxes are
thereafter put back at the appropriate position as
indicated in the bottom of the outer storage box.
WARNINGS
• TO AVOID THE TRANSFER OF DISEASE,
NEVER USE A CONTAMINATED SIZER
LARYBUTTON.
After using a Sizer LaryButton, 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 LaryButton and its individual storage box
back in the outer storage box after use. Make
sure that each used Sizer and individual storage
box is cleaned, disinfected, dried and steam
sterilized. The outer storage box must also be
cleaned if contaminated.
• The Sizer LaryButtons are intended for the
sizing procedure only. After the correct size(es)
have been determined, new LaryButton(s) shall
be used by the patient.
PRECAUTIONS
• To reduce risks of traumatizing the tracheostoma
during the Sizing procedure: Carefully read
the LaryButton Manual before using the
LaryButton Sizer Kit in order to understand
the warnings, precautions and instructions for
use of the LaryButton during insertion and
replacement.
• 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 steam sterilization.
Adverse events
The following are possible risks associated with
the use of LaryButton Sizer Kit:
• Transfer of disease(s). In order to reduce the
risk, use appropriate hygienic procedures.
Clean, disinfect, dry and steam sterilize the
Sizer LaryButton and individual storage box.
• Use of wrong size Sizer LaryButton during
sizing procedure. To reduce the risk, make sure
that the correct Sizer LaryButton is packaged in
