Atos Medical PROVOX LaryButton Instrucciones De Uso página 11

of the trachea could be harmed and/or the voice prosthesis
could become dislodged and subsequently be aspirated or
ingested.
• DO NOT use lubricating gels if the patient has allergies
related to these substances.
• Always remove the device from the stoma before cleaning.
DO NOT at any time attempt to clean the device while
inside the stoma since this could cause tissue damage and
dislodgement of voice prosthesis.
• Make sure that the patient has been trained in the use of
the device, and has demonstrated the ability to understand
and consistently follow the Instructions for Use without
clinician supervision.
1.5 PRECAUTIONS
• DO NOT use a dirty or contaminated Provox LaryButton.
Clean and disinfect the device according to the cleaning and
disinfection instructions below.
• DO NOT use toothed or sharp instruments at any time
during insertion since they could damage the LaryButton
and cause tissue damage.
• DO NOT use a damaged device since this might cause
aspiration of small parts or cause formation of granulation
tissue.
• Only use water-soluble lubricants. Oil-based lubricants
(e.g., Vaseline) may weaken, damage, or destroy the product
and should not be used at any time.
• Carefully monitor the tracheostoma tissue during radiation
therapy and stop using the device if the stoma gets irritated
or starts to bleed.
• Patients with bleeding disorders or patients on anticoagulants
should not use the device if it causes bleeding that re-occurs.
• Stop using the device if granulation tissue forms in the
tracheostoma.
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