EN-3
CONTRA-INDICATIONS AND CAUTIONS
Reuse of the Tongue Pressure Probe is prohibited.
Replace for each measurement to avoid measurement errors or infection.
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Precautions for use
1.
As the device is a measuring device, it should not be used for definite diagnosis
such as the assessment for swallowing function.
2.
Do not sterilize Tongue Pressure Probe and Connecting Tube.
[Deformation or
deterioration of components may cause measurement error or measurement failure.]
3.
Do not touch the balloon at internal pressure adjusting. Also, do not adjust
internal pressure while the balloon is placed in the oral cavities.
[Incorrect internal
pressure adjustment may cause measurement error or measurement failure.]
4.
Do not pinch the balloon and Connecting Tube with forceps or tweezers.
[Damage
to the balloon and Connecting Tube may result in measurement failure.]
5.
Do not drop or give physical impact to the device.
[It may cause the device to break.]
6.
Do not use the device by connecting to another device.
[It may cause malfunction or
measurement failure.]
7.
Do not use unintentionally radiating devices (electrosurgical devices that are
outputting, radios, TVs, etc.) nearby.
[It may cause malfunction.]
8.
Do not use devices that use radio waves (mobile RF communication equipment such
as mobile phones and transceivers, peripheral devices such as antenna cables and
external antennas) within 30 cm of the device.
[It may cause malfunction. If it is
unavoidable, check the operation.]
9.
Do not use anything other than the enclosed items or specified items.
[Increased
electromagnetic emissions or decreased electromagnetic immunity may cause
malfunctions.]
1.
Should be used by a physician
, a dentist, or a nurse, a speech language pathologist,
or a dental hygienist under the direction of the physician or the dentist.
2.
Regardless the frequency of use, replace the Connecting Tube with a new one
monthly after unpacking.
[It may cause measurement error or measurement failure.]
3.
Instruct patients not to bite or pull the balloon.
[It may cause the balloon damage and
measurement failure. It also may result in accidentally swallowing of broken pieces of the
balloon.]
4.
When hold the hard ring with the front teeth, instruct patients not to bite strongly.
[It may damage teeth and prostheses.]
5.
Use a USB cable with a length of less than 3 m (enclosed item recommended).
[It may
cause communication error.]
6.
Use a CISPR 32 compliant personal computer.
[It may cause communication error.]
CAUTIONS
CONTRA-INDICATIONS
