DEVICE DESCRIPTION
EN-5
INTENDED PURPOSE
The intended purpose of the device is to investigate tongue motor function with Tongue Pressure Probe and
Connecting Tube and measuring maximum tongue pressure.
The device is intended for clinical use by a physician and a dentist, or a nurse, a speech language pathologist
or a dental hygienist under the direction of the physician or the dentist.
However, the device is not adapted for the following patients; patients may have difficulties on measuring
maximum tongue pressure or moving their tongues.
If judgment of adaptivity is difficult due to the patient's condition, check the condition by the physician or the
dentist, and then use the device safely under the instruction of their.
・
Patients who cannot recognize instructions by the operator (e.g. patients who cannot recognize
instructions by the operator with dementia, anepia, agnosia, higher brain dysfunction, infants the
intellectual disabled, etc.)
・
Patients who cannot hold the device with the front teeth (e.g. patients with edentulous jaw and without
dentures)
・
Patients who cannot compress the device (e.g. patients who cannot move the tongue at all)
OPERATING PRINCIPLE
The air in
the device is compressed by pressing the tongue pressure probe balloon. The pressure sensor of
the device detects the pressure at this time and displays
“
Tongue Pressure Value
”
on the LCD screen.
In addition, The device is no basic performance as the lack or deterioration of performance cannot lead to
unacceptable risks. (Any abnormality will not cause harm to the patient or user.)
CONSTITUTION
The device should be used in combination with the following accessories.
Model name
REF No.
Reference page
Tongue Pressure Probe
JF-TPP
Page EN-8
Connecting Tube
JF-TPT5
Page EN-8
