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E2 scientific tongueometer - Indications for Use; Safety Precautions

E2 scientific tongueometer
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© 2020 E2 Scientific Corp. Version 5.20.2020. All rights reserved.
Intended Use
The Tongueometer is a non-prescription medical device designed to measure and
increase tongue strength and endurance. The Tongueometer measures maximum
tongue strength and endurance, enables users to perform repetitive and isometric
exercise activities, and provides objective biofeedback via custom software installed on
a user’s mobile phone or tablet device. The device is safe for in-home use and in clinical
environments.
Indications for Use
The Tongueometer is a multi-user device designed to measure and exercise tongue
strength and endurance in patients with oral motor problems, including dysphagia and
dysarthria.
CONTRAINDICATIONS:
Do not use with children under the age of 3.
Do not place the Tongueometer bulb in the mouth of someone who is at
risk of having a seizure.
Do not use if you have past or present pain disorders involving the jaw or
mandible (e.g., TMJ disorder, myofascial pain disorder).
WARNINGS
Setup of the Tongueometer should be completed under the guidance of a
Speech-Language Pathologist (“SLP”) or similar medical professional.
The Tongueometer bulbs supplied by E2 Scientific Corp are not sterile and
are not intended for sterilization.
Only the Tongueometer bulbs supplied by E2 Scientific Corp should be
used with the Tongueometer. Do not use the Tongueometer bulbs with any
other device.
The Tongueometer bulbs are intended for individual use only. Please refer
to the manual for cleaning instructions between same-patient uses.
Keep the Tongueometer device and bulbs out of reach of children.
Discontinue use immediately if use results in mouth or throat pain and
contact your SLP or medical professional.
Safety Precautions
Please observe the following safety precautions when setting up and using your
Tongueometer device.
This device is only intended to measure and exercise tongue strength and
endurance.
While the device may be sold directly to patients with oral motor problems,
it is intended to be set up and used under the guidance of a medical
professional caring for patients with oral motor problems, such as an SLP.
To avoid measurement errors, carefully read and refer back to the user
manual when using the Tongueometer.
Do not use the device in or near water.
Discontinue use of the Tongueometer immediately if the bulb, device,
or other components are damaged.
Do not lift, carry, hang or pull the device by the external battery, cable,
bulb or bulb tube.
Discontinue use immediately if use results in pain in the mouth or throat
and contact your SLP or medical professional.