JMS TPM-02 User manual

INSTRUCTIONS FOR USE EN
EN-1
JMS Tongue Pressure Measurement Device
Table of Contents
INTRODUCTION ·················································································EN-2
SAFETY PRECAUTIONS······································································EN-2
SYMBOLS······································································································································EN-2
CONTRA-INDICATIONS AND CAUTIONS ····························································································EN-3
DEVICE DESCRIPTION········································································EN-5
INTENDED PURPOSE······················································································································EN-5
OPERATING PRINCIPLE ··················································································································EN-5
CONSTITUTION······························································································································EN-5
DEVICE SPECIFICATIONS················································································································EN-6
DESCRIPTION OF EACH PART ·········································································································EN-6
PREPARATION ································································································· EN-9
PACKING CONTENT························································································································EN-9
BATTERIES····································································································································EN-9
DIRECTIONS FOR USE ···················································································EN-10
NORMAL MEASUREMENT·············································································································· EN-10
MEASUREMENT CONNECTED WITH A PARSONAL COMPUTER ························································· EN-13
AUTO SAVE FUNCTION ················································································································· EN-13
MAINTENANCE AND INSPECTION·································································EN-14
DAIRY MAINTENANCE··················································································································· EN-14
DAIRY INSPECTION ······················································································································ EN-14
MAINTENANCE BY DISTRIBUTOR··································································································· EN-15
REPLACEMENT FREQUENCY AND TIMING ······················································································ EN-15
DISPOSAL INFORMATION·············································································································· EN-15
TROUBLESHOOTING······················································································EN-16
ERROR INDICATION······················································································································ EN-16
TROUBLESHOOTING ···················································································································· EN-17
EMC INFORMATION·········································································· EN-18
WARRANTY AND DISCLAIMERS························································ EN-20
WARRANTY ································································································································· EN-20
DISCLAIMERS ······························································································································ EN-20

INTRODUCTION
EN-2
Thank you for purchasing Digital Tongue Pressure Meter. Read this instructions for use (IFU) carefully before
use.
The device is used with Tongue Pressure Probe (REF No. JF-TPP) and Connecting Tube (REF No. JF-TPT5).
For Tongue Pressure probe and Connecting Tube, read each IFU.
In addition, any serious incident that has occurred in relation to the device should be reported to the
manufacturer and to the competent authority of the Member State in which the user and/or patient is
established.
SAFETY PRECAUTIONS
SYMBOLS
This manual and product use symbols to highlight important precautions and things that we want
you to know. Symbols and their content are shown below.
■Symbols used in this manual
Indicates the target and usage methods that exceed the scope of
responsibility, such as design limits or improper use of the device.
Indicates items that may cause damage or property damage if
handled incorrectly.
Indicates a prohibited action. Please do not attempt to do this.
Indicates an action that must be followed. Please be sure to follow the instructions.
■Symbols displayed on the device
Consult instructions for use
Date of manufacture
The degree of protection against electrical
shock is BF-type applied parts (Tongue
Pressure Probe and Connecting Tube)
Manufacturer
Catalogue number
Serial number
Batch
Expiry date
Single use only
Storage temperature limit is
-20 ~ +50℃(-4 ~ +122 °F)
Keep dry
Keep away from sunlight and heat
Medical device
Do not use if package is damaged
Caution: Federal (U.S.A.) law restricts the
device to sale by or on the order of a physician
and a dentist.
WEEE mark
Not for general waste.
Authorized representative in the European
Community
CONTRA-INDICATIONS
CAUTIONS

EN-3
CONTRA-INDICATIONS AND CAUTIONS
Reuse of the Tongue Pressure Probe is prohibited.
Replace for each measurement to avoid measurement errors or infection.
■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

EN-4
■Storage method and validity period
1. Store and use the device within the following conditions.
<Storage condition>
・Ambient Temperature: -20 ~ 50 ℃ (-4 ~ 122℉)
・Ambient Humidity: 10 ~ 95%RH (no condensation)
<Operating environment>
・Ambient Temperature: 10 ~ 40 ℃ (50 ~ 104℉)
・Ambient Humidity: 30 ~ 75 %RH (no condensation)
2. Do not store or use in the following locations.
・Where the device is exposed to direct sunlight or strong light
・Where the atmospheric pressure is depressurized or pressurized
・Where there is dust or corrosive gases (salt, sulfur), etc. in the atmosphere
・Where vibration occurs or the area is not level
・Where heating devices or devices that generate heat are nearby
・Where the device is exposed to excessive humidity or moisture
3. Please observe the following validity period.
<Validity period> (Refer to the validity date on the package)
・Tongue Pressure Probe and Connecting Tube: 3 years [based on self-certification
(Manufacturer’s own data)]
<Period of endurance>
・Digital Tongue Pressure Meter: 5 years [based on self-certification (Manufacturer’s own
data)](When specified maintenance, inspection, and replacement of consumables are
performed)
・Connecting Tube: 1 month after opening package [based on self-certification (Manufacturer’s
own data)]
■Maintenance and Inspection
1. Do not use benzene, thinner or other volatile chemicals to clean the device.
[There is a risk of deterioration or deformation of the device body.]
2. Be careful not to apply liquid to the device and the Connecting Tube. [Liquid may
penetrate the device, and it may cause malfunction or failure.]
3. Do not mix old batteries and different types of batteries. [Battery fluid leakage may
cause the failure of the device.]
4. Do not disassemble or modify the device. [It may cause the failure or damage of the
device.]
5. Turn off the power before replacing the batteries. [It may cause the device failure.]
1. Insert the batteries in correct direction. [Battery fluid leakage may result in damage.]
2. When the device is not used for a long time, remove the batteries for the storage.
[Battery fluid leakage may result in damage.]
CAUTIONS
CAUTIONS

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

EN-6
DEVICE SPECIFICATIONS
Item
Specification
Device name
JMS Tongue Pressure Measurement Device
Model name
Digital Tongue Pressure Meter
Model type
TPM-02
Power supplies
AA alkaline battery × 2 or AA nickel-metal-hydride rechargeable battery × 2
Electrical
rating
Voltage
DC 3V (Two AA alkaline batteries)
DC 2.4V (Two AA nickel-metal-hydride rechargeable batteries)
Measureable
number
Approx. 2,500 times (Assuming use of a new batteries or rechargeable batteries
within one month at room temperature)
Durability
5 years (About 45,000 pressurization pump operations)
Dimensions
74 (W) × 120 (L) × 27.5 (H) mm
Internal
pressure
adjustment
Set value
19.6 kPa (Automatically displays zero after internal pressure adjustment)
Adjustment time
Within 20 seconds
Accuracy
±1.0 kPa (at the set value of internal pressure 19.6 kPa)
Measurement
Display unit
kPa
Display range
-9.9 to 99.9 kPa (when the zero is set at 19.6 kPa)
Accuracy
±1 kPa (at 0.0 to 80.0 kPa when internal pressure setting value of 19.6 kPa is set to zero.)
Display format
Digital numbers and bar graphs (Level sign indication)
Electric shock protection type
Internal power supply BF type applied parts
Drip-proof properties
IPX0
EMC
IEC 60601-1-2 : 2014 / EN IEC 60601-1-2: 2015
External output function
USB (data transmission only)
Option
Software for Tongue Pressure Measurement Data
MFDS Import Certificate No.
20-164
DESCRIPTION OF EACH PART
■Digital Tongue Pressure Meter
1．Front view
Connecting tube port cap
Protects the connecting tube port.
Power button
Turns the power ON-OFF.
Prep / Reset Button
When the key is pressed with the power
turned on, adjusts the internal pressure
of the connected the device and the
accessories.
LCD screen
Displays tongue pressure values, etc.
Body
Outer cover of the device.
USB port cap
Protects the USB port.

EN-7
2．LCD screen
※If a pressure value of 80 kPa or more is detected, the display flashes because the pressure value is out of the
measurement accuracy range.
3．Rear view
4．Top view
Battery icon
Displays the remaining power of battery in four levels.
Maximum tongue pressure value (MTP) ※
Displays the maximum tongue pressure.
Present tongue pressure value (PTP) ※
Displays real-time tongue pressure.
Level sign indication
Indicates a pressure change.
“Error” icon
Lights when an
error occurs.
“Wait” icon
Lights during internal
pressure adjustment.
“Measure” icon ※
Lights when the internal pressure is
adjusted and measurement is ready.
Rating plate
Indicates the serial number, etc.
Battery cover
When replacing the batteries, please open this
part and replace the batteries.
Slide it to open/close.
Connecting tube port
Connects the Connecting Tube.
USB port
Connects the USB cable.

EN-8
■Tongue Pressure Probe (Accessory)
Tongue Pressure Probe receives tongue pressure during measurement. (single use only).
■Connecting Tube (Accessory)
Connecting Tube connects the device to the Tongue Pressure Probe. The accessory is a replacement part
which can be used for one month after opening the individual package.
Balloon
Receives tongue pressure by compressing
between tongue and palate.
Material: Thermoplastic styrenic elastomer
Hard ring
Lightly holds the diagonal part with
the front teeth to position the balloon
on the tongue.
Material: Polypropylene
Grip
Holds by hand when measuring.
Tongue pressure probe connector
Screws into the connecting tube connector.
Connecting tube connector
Connects by screwing into the device and the Tongue Pressure Probe.
O-ring is installed near the tip to maintain airtightness.
Tube
Transmits the tongue pressure received by
the Tongue Pressure Probe to the device.

PREPARATION
EN-9
PACKAGING CONTENT
The device package contains the following items. If anything is missing, contact your local dealer.
・Digital Tongue Pressure Meter ・USB cable ・Storage case ・AA alkaline batteries
(1 unit) (1 unit) (1 bag) (2 units)
・IFU (this manual, 1 copy)
BATTERIES
1．Remove the battery cover from the device.
2．Mount AA batteries in the proper direction.
3．After mount batteries, slide the battery cover tightly.
Slide with holding down here
* The supplied batteries are for
trial use only.
It may expire within 2,500
measurements, and please
replace it as soon as possible.

DIRECTIONS FOR USE
EN-10
NORMAL MEASUREMENT
1. Connect each accessory to the device
1) Remove the connecting tube port cap from the device.
2) Connect one side of the connecting tube connector securely to the
connecting tube port and the other side of the connecting tube
connector securely to the Tongue Pressure Probe.
2. Turn on
Press the power button on the device to turn it on.
The LCD screen lights with a buzzer sound and after all indications are displayed, the unit
automatically enters the standby mode.
<Power OFF> <FULL Display> <Standby mode>
3. Adjust the internal pressure automatically
Make sure the device is in standby mode and press the Prep/Reset button.
The internal pressure is automatically adjusted and zero-point correction is performed.
<Operation of the device>
1. When the Prep/Reset button is pressed, the pressurization pump operates with a beeping sound, and the internal pressure
adjustment starts. At this time, the “Wait”icon on the LCD screen flashes and the “PTP”value increases. The Level sign indication will
also increase to the right. When the total number of the Level sign indication reaches 10, it indicates that the set value of internal
pressure has reached 19.6 kPa.
2. When the inside of the connected the device and accessories is adjusted to 19.6 kPa, “MTP”, “PTP”and Level sign indication are
automatically reset and “Measure”icon lights. In this status, it is ready for the measurement.
<Standby mode> <Adjusting internal pressure> <Ready for the measurement>
Measurement preparation
Hold only the grips of the Tongue Pressure Probe while adjusting the internal pressure. Touching the
balloon or tube at this time may cause incorrect internal pressure adjustment resulting in
measurement errors or impossibility.
CAUTIONS
Screw without gap

EN-11
4. Measure the maximum tongue pressure
1) Confirm that the “Measure” icon of the device lights and it is ready for measurement.
2) Insert the Tongue Pressure Probe into the patient's oral cavity and instruct the patient to gently hold
the hard ring of the Tongue Pressure Probe with the front teeth.
This will position the balloon on the tongue and allow you to take correct measurements. At the same time, the lower jaw is fixed.
<POINT>
Please pay attention to the orientation of the balloon and insert the balloon into the oral cavity so that the flat surface of the
balloon (the surface without the “line”) can be put on the tongue. Check the orientation before adjusting the internal
pressure for easy identification.
Lightly hold the thin portion
indicated by the diagonal line
with the front teeth.
Measuring
A denture user should wear a denture for the measurement.
Instruct not to bite the balloon absolutely. It may damage the balloon and result in unmeasurable.
Also there is a risk of swallowing the fragments.
When griping the hard ring with the front teeth, instruct not to grip it strongly. It may damage the
teeth and prostheses.
<Balloon Side View>
<Balloon Front View>
Line
Line
Line
Balloon
Tongue
Front
teeth
Grip
Grip here during the
measurement.
Hard ring
Decide the position by
holding with the front teeth.
Position to be held
with the front teeth
CAUTIONS

EN-12
3) While keeping the patient gently holding the hard ring with the front teeth, instruct the patient to push
up the tongue with the maximum force against the hard palate and compress the balloon for several
seconds.
4) Stop compressing with the signal from the operator, and record the value displayed on the “MTP”
display of the device as the maximum tongue pressure.
5) After measuring, remove the Tongue Pressure Probe from the patient's mouth.
6) To repeat measuring the same patient, press the Prep/Reset button again to reset the “MTP” and
“PTP”displays. After that, perform the operations 4.1) to 5) in the same way.
※If the “PTP”exceeds 1 kPa, the Prep/Reset button becomes invalid, and turn the power off and on again.
5. Complete the measurement
1) Press the power button on the device to turn it off.
2) Disconnect the Tongue Pressure Probe from the Connecting Tube and dispose of properly.
3) If you want to continue measuring the next patient, connect the new Tongue Pressure Probe to the
Connecting Tube and repeat the procedure from step 2.
4) After all patients’ measurements are completed, disconnect the Connecting Tube from the device.
5) Attach the connecting tube port cap to the connecting tube port.
Hard palate
Balloon
Push up
In this case, “37.6 kPa” is the
maximum tongue pressure.
End of the measurement
“PTP” display shows real-time tongue pressure.
The Level sign indication display shows a real-time
tongue pressure of 0-50 kPa with 10-part icons.
Approximately 7 seconds should be used for the
compressing time.

EN-13
MEASUREMENT CONNECTED WITH A PERSONAL COMPUTER
1．Remove the device's USB port cap.
2．Connect the device's USB port to the personal computer's USB port with a USB cable.
3．Turn on the personal computer and the device.
4．The tongue pressure is measured and the tongue pressure value is displayed and stored on a
personal computer.
AUTO SAVE FUNCTION
The device changes to the following status if no operation is performed after the power is turned ON or if the
pressure fluctuation of 1.0 kPa or more is not detected.
1) 10 seconds later ⇒Backlight dimming
2) 3 minutes later ⇒Power OFF
10 seconds
later
※Measurement is possible even when the backlight is
dimmed. When a pressure fluctuation of 1.0 kPa or
more is detected, the brightness returns to the
original level.
※When the Prep/Reset button is pressed to enter the
internal pressure adjustment mode, the brightness
also returns to the original value.
3 minutes
later
※If this happens, turn the power on again.

MAINTENANCE AND INSPECTION
EN-14
DAILY MAINTENANCE
■Digital Tongue Pressure Meter
1. Turn the power off and remove the batteries.
2. Wipe the dirty area with a soft and dry cloth.
3. For stubborn dirt, soak the cloth in water and a neutral detergent, wring well, and then wipe the
dirt off. Remove wetness with a dry cloth.
■Connecting Tube
1. Disconnect Connecting Tube from the device.
2. Wipe the dirty area with a soft and dry cloth.
3. For stubborn dirt, replace it with a new Connecting Tube even if it is less than one month after
unpacking.
DAILY INSPECTION
Correct operation and daily inspection are essential to maintain the device performance over a long
period of time and to ensure safe use. Check the following items before use.
(Copy it to use.)
Daily check item
Check
Inspection before use
□Check the device for damage, cracks, etc.
□Is the tongue manometer free of liquid or dirt?
□Is there any foreign matter and damage on the connecting tube port of the device or the connecting tube
connector?
□Check if the Connecting Tube is not bent or damaged.
Inspection during use
□Is the power turned on correctly?
□Is the battery icon low?
□Is the standby display normal?
□Is the internal pressure adjustment operating normally?
□Are the “PTP”display, the “Wait”icon’s flashing, and the Level sign indication display normal during
internal pressure adjustment?
□Is the pressurization error occurring during internal pressure adjustment?
□Check that the device is ready for measurement after adjusting the internal pressure. Is the “Measure” icon
lighted normally?
□Is a measurement error occurring during measurement?
□Is there any smoke/unusual smell generating from the device?
□Is there any abnormal noise?
Inspection after use
□Is the device free of liquid or dirt?
□Is there a specific part of the device that is hot?
□Is there any foreign matter on the connecting tube port or the connecting tube connector of the device, or is
it damaged?
□Check that the Connecting Tube is not bent or damaged.

EN-15
MAINTENANCE BY DISTRIBUTOR
We perform maintenance and inspections described below. Contact your supplier for more information.
Item
Frequency
Inspection details
Periodic
inspection
Once a year
Check the internal pressure adjustment accuracy and measurement accuracy with special jigs
and measuring instruments, and perform periodic adjustments and repairs.
REPLACEMENT FREQUENCY AND TIMING
Exchange frequency
Replacement part
Approximately 2,500 measurements
AA alkaline batteries or AA nickel-metal hydride rechargeable batteries
(two batteries at the same time)
※Refer to page EN-9 for the replacement procedure.
Every measurement
Tongue Pressure Probe
One month after opening
Connecting Tube
DISPOSAL INFORMATION
WEEE (Waste Electrical and Electric Equipment) should not be disposed as general waste.
After using the device, dispose of it properly according to local or national regulations.
Tongue Pressure Prove is medical waste.
For other items, please refer to the following table and dispose it as general waste under
the instructions of local or national authorities.
Product Name
Component
Raw material
Packaging
(common materials)
Box
Paper
Cushioning material or individual packaging bag
Polyethylene
Digital Tongue
Pressure Meter
Body (including operation buttons and battery cover)
Acrylonitrile-butadiene-styrene copolymer
Internal part
General electrical parts, Stainless steel
Connecting Tube
Connecting tube connector
Polycarbonate
Tube
Polyvinyl chloride
O-ring
Nitrile rubber
USB cable
General electrical parts
Storage case
Polyamide
The Tongue pressure Probe is prohibited from being reused because it causes measurement errors and
infections.
When replacing batteries, replace two AA alkaline batteries or AA nickel-metal hydride rechargeable batteries
at the same time.
If the connecting tube becomes severely dirty or folded, it may cause measurement error. Replace the
connecting tube as needed.
CAUTIONS
CONTRA-INDICATIONS

TROUBLESHOOTING
EN-16
ERROR INDICATION
If an error occurs during use, the error message shown below appears.
Error indicator
Cause
Corrective action
<Pressurization error>
The beeper beeps three
times to notify you.
Each component is not connected properly.
If any of the connections are loose, reconnect them
correctly. (See page EN-10.)
A broken Tongue Pressure Probe or the
Connecting Tube was used.
Replace with new Tongue Pressure Probe or new
Connecting Tube. (See page EN-10.)
The power button or Prep/Reset button was
accidentally pressed during internal pressure
adjustment.
Press the Prep/Reset button again to adjust the
internal pressure. (See page EN-10.)
The balloon of the Tongue Pressure Probe
was mistakenly crushed during internal
pressure adjustment.
Press the Prep/Reset button again to adjust the
internal pressure. (See page EN-10.)
The internal pressure adjustment was not
completed within the specified time because
the battery level was low.
Replace with new batteries. (See page EN-9.)
The device is defective.
Please contact your supplier for repair.
<Measurement Error>
The beeper beeps three
times to notify you.
Loose connections in each component during
the measurement.
If any of the connections are loose, reconnect them
correctly. (See page EN-10.)
The Tongue Pressure Probe or Connecting
Tube was broken during the measurement.
Replace with a new Tongue Pressure Probe or
Connecting Tube. (See page EN-10.)
The device is defective.
Please contact our personnel for repair.
<Low Battery>
The batteries are exhausted.
Replace with new batteries. (See page EN-9.)

EN-17
TROUBLESHOOTING
Phenomenon
Cause
Corrective action
Internal pressure adjustment
takes time.
Each component is not connected properly.
Check the connection of each part. If not, connect
properly. (See page EN-10.)
A broken Tongue Pressure Probe or a
Connecting Tube was used.
Replace with new Tongue Pressure Probe or
Connecting Tube. (See page EN-10.)
The batteries are exhausted.
Replace with new batteries. (See page EN-9.)
The device is defective.
Please ask for repair service.
Maximum tongue pressure
cannot be measured
correctly and is measured at
an abnormally low (high)
value.
The device is defective.
Please ask for repair service.
Measurements were made when the
Connecting Tube was bent.
Perform measurement again without bending.
The balloon was bitten during the
measurement.
Position the balloon correctly and compress the
balloon with tongue only. (See page EN-11-12.)
Loose connections in each component part
during the measurement.
Check for loose connections and reconnect
correctly. (See page EN-10.)
Tongue Pressure Probe or Connecting
Tube was broken during the measurement.
Replace with new Tongue Pressure Probe or
Connecting Tube. (See page EN-10.)
The device does not start
when the power button is
pressed.
The batteries are exhausted.
Replace with new batteries. (See page EN-9.)
The “+”and “-”side of the battery are
reversed.
Mount the batteries in the correct direction. (See
page EN-9.)
A “click” sound is heard
when the power is turned
ON, when the Prep/Reset
button is operated, or when
the power is turned OFF.
The solenoid valve opens and closes
automatically to return the measuring
system circuit to the atmospheric pressure.
This is normal and does not indicate a problem. The
device can be used safely.
Even if a new battery is
installed, the remaining
Battery icon is displayed low
or the Low battery is
displayed.
Battery performance may not meet the
device criteria, or may be degraded or
depleted.
※Batteries may deteriorate depending
on the storage environment.
If Low Battery is displayed, replace batteries with
new ones.
Even if Battery icon is displayed low, you can still
use it if Low Battery is not displayed. (See page
EN-9.)

EMC INFORMATION
EN-18
The device complies with the EMC (Electromagnetic Compatibility) standard (IEC 60601-1-2: 2014/ EN IEC
60601-1-2: 2015).
The device may cause malfunctions such as LCD error (MTP, PTP, other indications), freeze, reset, power
off etc. if it is not used under specified environmental conditions and exposed to strong Electromagnetic
disturbances.
Check the following compatibility carefully before installation and use.
Intended environment: Home medical environment (residential area_residential/home/nursing facility)
■Emission test
Emission test
Standard / Test level
Compliance
Conducted emissions
CISPR 11 Group 1, Class B
Not applicable
Radiated emissions
Group 1, Class B
Harmonic emissions
IEC 61000-3-2
Not applicable
Voltage fluctuations/flicker emissions
IEC 61000-3-3
Not applicable
■Immunity test
Immunity test
Standard / test level
Compliance level
Electrostatic discharge (ESD)
IEC 61000-4-2
±8 kV contact
±2, 4, 8, 15 kV air
±8 kV contact
±2, 4 ,8, 15 kV air
Electrical fast transient/burst
IEC 61000-4-4
±2 kV for power supply lines
±1kV for input/output lines
USB cable
±1kV for input/output lines
Surge
IEC 61000-4-5
±1 kV for line(s) to line(s)
±2 kV for line(s) to earth
Not applicable
Voltage dips, short
interruptions and voltage
variations on power supply input
lines
IEC 61000-4-11
Voltage dips
0 % UT0.5 cycle
Phase angle
0°, 45°, 90°, 135°,180°, 225°, 270°and 315°
0 % UT1 cycle and 70 % UT 25/30 cycle
Single layer phase angle 0°
Short interruption
0 % UT 250/300 cycle
Not applicable
Power frequency
(50/60 Hz) magnetic field
IEC 61000-4-8
3 A/m
3 A/m (50/60 Hz)
Conducted RF
IEC 61000-4-6
3 Vrms in between 0.15 MHz and 80 MHz
6 Vrms in ISM and amateur radio bands between 0.15 MHz
and 80 MHz
80% Amplitude modulation (1 kHz)
USB cable
3 Vrms in between 0.15 MHz and 80 MHz
6 Vrms in ISM and amateur radio bands
between 0.15 MHz and 80 MHz
80% Amplitude modulation (1 kHz)
Radiated RF
IEC 61000-4-3
10 V/m
80MHz ~ 2.7GHz
80% Amplitude modulation (1 kHz)
10 V/m
Immunity to near
electromagnetic fields from RF
wireless communication
equipment
IEC 61000-4-3
According to Table-1
According to Table-1

EN-19
Recommended separation distances between portable and mobile RF communications equipment and the device.
The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customers or user can
help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power
of the transmitter (W)
Separation distance according to frequency of transmitter (m)
150 kHz to 80MHz
d=1.2
P
80 MHz to 800 MHz
d=1.2
P
800 MHz to 2.5 GHz
d=2.3
P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance din meters (m) can be estimated using
the equation applicable to the frequency of the transmitter.Where Pis the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
Remarks 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Remarks 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects and people.
Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a), should be less
than the compliance level in each frequency rangeb).
Interference may occur in the vicinity of equipment marked with the following symbol:
Note a) Field strength from fixed transmitters such as base stations for radio (cellular/cordless) telephone and land mobile radios, amateur radio,
AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used
exceeds the applicable RF compliance level above the device should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the device.
b) Over the frequency range 150 kHz and 80 MHz, field strengths should be less than 3V/m.
Table 1 –Test specifications for Enclosure port immunity to RF wireless communications equipment
Test
frequency
(MHz)
Band
(MHz)
Communication
service
Modulation
Maximum
power
(W)
Separation
distance
(m)
Immunity
test level
(V/m)
Compliance
(Compliance
level)
385
380 - 390
TETRA400
Pulse modulation
18 Hz
1.8
0.3
27
27
450
430 - 470
GMRS 460
FRS 460
Frequency modulation ※
±5 kHz deviation
1 kHz sine
2
0.3
28
28
710
704 - 787
LTE Band 13, 17
Pulse modulation
217 Hz
0.2
0.3
9
9
745
780
810
800 - 960
GSM 800/900 ,
TETRA 800,
iDEN 820 , CDMA
850, LTE Band 5
Pulse modulation
18 Hz
2
0.3
28
28
870
930
1720
1700 - 1990
GSM 1800, CDMA
1900, GSM 1900
DECT, LTE Band 1, 3,
4, 25, UMTS
Pulse modulation
217 Hz
2
0.3
28
28
1845
1970
2450
2400 - 2570
Bluetooth, WLAN
802.11 b/g/n, RFID
2450 LTE Band 7
Pulse modulation
217 Hz
2
0.3
28
28
5240
5100 - 5800
WLAN 802.11 a/n
Pulse modulation
217 Hz
0.2
0.3
9
9
5500
5785
※As an alternative to frequency modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it
would be worst case.

WARRANTY AND DISCLAIMERS
EN-20
WARRANTY
JMS CO., LTD. hereby warrants to the original purchaser that reasonable care has been used in the manufacture of
DIGITAL TONGUE PRESSURE METER and that, when properly used, it will be free from defects in material and/or
workmanship for a period of 18 months after the date of shipment from JMS’s factory. The exclusive remedy with
respect to any instrument or component found within this warranty period not to meet these standards is that, after
return to and examination by JMS’s designated representative, JMS will without charge at its option either repair or
replace an instrument found to be defective.
This warranty shall not apply if the instrument has been repaired by anyone other than a qualified service personnel
member approved by JMS, or altered in any way which, in JMS’s judgment, affects its stability or reliability; nor if the
serial number has been altered, effaced, or removed; nor if the fault has been caused by misuse or abnormal conditions
of operation.
In such cases, JMS or its designated representative will notify the purchaser of JMS’s determination, and repairs, if
requested, be billed at JMS’s designated representative’s normal rates. Estimates will be submitted before any repair
work is started, if requested.
THIS WARRANTY IS MADE IN LIEU OF OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
DISCLAIMERS
1. The device is a device that provides valuable information for evaluating the function of swallowing, but does not
provide diagnostic information. We are not responsible for any adverse effect on health conditions as a result of
diagnoses based on the device measurements.
2. The result measured by the device is the data obtained at the time of measurement. As the symptom may change
suddenly, do not judge the measurement data by yourself, and contact a doctor. We are not responsible for any
adverse effects on health conditions.
3. We are not responsible for damages caused by earthquakes, thunders, winds, floods, fires other than our
responsibility, actions of third parties, other accidents, your intent or negligence, misuse, or other abnormal
conditions.
4. We are not responsible for any involuntary damages (loss of business profits, business interruption, etc.) arising
from the device use or device failure.
5. We are not responsible for any damages arising from failing to follow this manual’s contents.
6. We are not responsible for any damages arising from malfunction due to a combination of connected devices and
software in which we are not involved.