EP-2100A/EP-2100 | MIDDLE EAR INFLATION DEVICE
INTENDED USE/INDICATIONS FOR USE
The EarPopper is intended to be used for the treatment of Otitis Media with
Effusion, Eustachian Tube Dysfunction, and ear fullness caused by air travel
and scuba diving.
The EarPopper is indicated for use in the treatment of negative middle ear
pressure.
Negative middle ear pressure can lead to fluid accumulation in the middle
ear, impaired hearing and hearing loss. The EarPopper provides a method
for ventilating the middle ear by introducing air through the nose and
Eustachian tube into the middle ear. Equalizing middle ear pressure can
prevent the accumulation of fluid and prevent hearing loss.
INTENDED USER
The EarPopper is intended to be used by the patient or parent/guardian
after consulting a physician.
PRECAUTIONS
• CAUTION: A LICENSED PHYSICIAN SHOULD BE CONSULTED PRIOR
TO USE.
• To ensure compliance, the physician should demonstrate proper use of
the EarPopper.
• DO NOT force the instrument into the nasal cavity.
• DO NOT use without a clean, intact nose piece attached.
• Adult supervision is required when using this product on children.
• Submerging device in water may result in product failure.
• Stop using EarPopper if ear discomfort occurs during use.
• Patients with pre-existing conditions should seek additional advice
from a healthcare professional prior to use. Use of the device in these
circumstances may lead to perforation of the eardrum.
• Discontinue use if device is damaged.
PARTS OF THE EARPOPPER
Removable Nosepiece
Power Button
Battery Strip
Battery Compartment
3
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