Descriptive Information; Intended Use; Description Of The Device - PROVOX TruTone Emote Manual De Instrucciones

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1. Descriptive information

1.1 Intended use

An electrolarynx is a battery-powered artificial larynx that is externally applied
and intended for use in the absence of the ability to use the larynx to produce
sound. When held against the skin in the area of the voicebox, or by insertion of
a tube in the oral cavity (with an oral adapter), the device generates mechanical
vibrations which resonate in the oral and nasal cavities and can be modulated by
the tongue and lips in a normal manner, thereby allowing the production of speech.
1.2 Contraindications
The device should only be used in accordance with the Instructions for Use.
Users without the physical, cognitive, or mental ability required to operate the
device themselves, should not use the device independently and should only use
it if they are under sufficient supervision of a clinician or a trained caregiver.
The device should not be directly applied over frail neck tissue with weak blood
vessels. This can cause tissue damage or bleeding. Patients with this condition
should only use the device when they have been specifically instructed by their
clinician about how to use the device and where to safely apply it.

1.3 Description of the device

An electrolarynx is a battery-powered artificial larynx that is externally applied on
undamaged skin and intended for use in the absence of the larynx or the inability
to use the larynx to produce sound.
1.4 Warnings
• Failure to follow the safety instructions could result in personal injury, or
damage the device. Read all safety information below before using the device.
• Incorrect use of the device or not following instructions in this IFU can cause
personal injury and/or damage the device.
• Do not use the device between persons, this can cause cross contamination.
The device is intended for single patient use only.
• Do not turn on, or use, or charge the device if it has been exposed or dropped
in water or other liquids, as it can cause personal injury and/or damage the
device.
• Before charging inspect the charger for damage. A damaged or non-
functioning charger shall no longer be used, as it can cause fire, personal
injury or damage the device.
• Only use approved chargers, as usage of unapproved chargers can cause fire,
personal injury, or damage to the device.
• Do not attempt to charge non-rechargeable batteries, as this could result in
personal injury or damage the device.
• Do not replace rechargeable batteries with non-rechargeable batteries, as this
could result in personal injury or damage the device.
• Do not physically damage the batteries, as this could result in personal injury
or damage the device.
• Do not store batteries in a pocket, purse, box or drawer etc. where they may
short-circuit each other, or be short-circuited by conductive materials such as
coins or keys, as this could result in personal injury or damage the device.
• Do not use a leaking battery as it could result in personal injury or damage
the device.
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