Electrolarynx speech aid information
Intended use: An electrolarynx is a battery-powered artificial larynx that is
externally applied and intended for use in the absence of 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. This device is intended for multiple uses by a single patient.
Intended operator: The patient is the intended operator.
Applied part:The entire device is considered a Type BF Applied Part
Environmental conditions for operation: +5°C to +25°C; 15% to 93% relative
humidity; 700 hPa to 1060 hPa
Environmental conditions for transportation and storage: To maintain optimal
battery life, maintain the following environmental conditions: -20°C to +25°C;
0% to 45% relative humidity.
Mode of operation: 30 minutes of activation during a 24 hour period
Power source: Internally powered.
Expected service life: The expected service life is 1-5 years depending on use
frequency and care taken to prevent wear and damage.
Magnetic and electromagnetic fields:
• This device complies with part 15 of the FCC rules. Operation is subject
to the following two conditions: (1) This device may not cause harmful
interference, and (2) this device must accept any interference received,
including interference that may cause undesired operation.
• Note: This equipment has been tested and found to comply with the limits
for a Class B digital device, pursuant to part 15 of the FCC rules. These limits
are designed to provide reasonable protection against harmful interference
in a residential installation. This equipment generates, uses and can radiate
radio frequency energy and, if not installed and used in accordance with
the instructions, may cause harmful interference to radio communications.
However, there is no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment off
and on, the user is encouraged to try to correct the interference by one or more
of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which
the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.
• This device complies with CAN ICES-3(B)/NMB-3(B)
Warnings:
• Do not insert any part of the electrolarynx or tube or any accessories into the
stoma.
• Do not burn or physically damage the battery.
• Do not charge non-rechargeable batteries.
• Devices and batteries may become warm (up to 45°C) during charging.
Allow the device to cool before use if it becomes too warm.
• Do not short-circuit a cell or battery. Do not store cells or batteries
haphazardly in a pocket, purse, box or drawer where they may short-circuit
each other or be short-circuited by conductive materials such as coins or keys.
• Use caution when replacing the battery. Incorrect installation of the battery
may result in a hazardous situation, such as extreme heat or fire.
• Electrolarynx devices contain a magnet that generate magnetic and
electromagnetic fields that may interfere with pacemakers or other implantable
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