Adverse Events; Checkout Procedures - Atos Medical Provox Dilator 7211 Mode D'emploi

• Allergic reactions against the lubricating
(anaesthetizing) gel may occur, read the
instructions for use accompanying the lubricant.
Always ask the patient about allergic history.
PRECAUTIONS
• Do not use any kind of oil or ointment for
product care or during the procedure. Oil
based lubricants (e.g. Vaseline) will weaken,
damage or destroy the product and shall not
be used at any time.
• Patients on anticoagulant therapy should be
carefully evaluated for the risk of hemorrhage
prior to dilation of the puncture.
• Make sure that the position chosen on the
dilator is adequate for the puncture. Over-
dilatation may result in leakage around the
voice prosthesis.
• Never use excessive force to insert or remove
the dilator from the puncture, this may cause
bleeding or a false route.
• Do not use a contaminated dilator. Conta-
minated dilators may cause infection and
inflammation.
• It is advisable to lubricate the dilator. Only
use water-soluble lubricants in an appropriate
amount.
• Do not use the dilator for a too long period of
time as this may damage the esophagus wall.

Adverse events

Bleeding from the puncture during insertion may
occur. Risk of bleeding can be reduced by inserting
the dilator gently and slowly. Allow sufficient
time for each section to dilate the puncture and
do not force the dilator through the puncture to
move to the next section.
Instructions for use

Checkout procedures

Always handle the dilator with clean gloves
and avoid touching parts of it that will enter the
puncture.
Check the integrity of the safety strap (3) by
holding the device handle (1) and slightly pulling
the medallion (2). Discard the device if it shows
any sign of damage.
Prior to use, it is advisable to lubricate the
dilator with some water soluble (anaesthetizing) gel.
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