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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.
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. See your devices user manual for full details.
Expected Service life:
The expected service life is between 1-5 years, depending on
the model. See your device warranty for the exact service life.
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)
