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INSTRUCTIONS FOR USE

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

Содержание TPM-02

Страница 1: ...T 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 INDIC...

Страница 2: ... 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...

Страница 3: ...ng 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 Increas...

Страница 4: ...d 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...

Страница 5: ...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 ...

Страница 6: ...ressure 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 ...

Страница 7: ...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...

Страница 8: ...y 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...

Страница 9: ...e 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 ...

Страница 10: ...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 reac...

Страница 11: ...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 ris...

Страница 12: ...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 ...

Страница 13: ... 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 ...

Страница 14: ... 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 indicati...

Страница 15: ... 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...

Страница 16: ...ngue 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 be...

Страница 17: ...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...

Страница 18: ...ontact 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 UT 0 5 cycle Phase angle 0 45 90 135 18...

Страница 19: ...g 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 ...

Страница 20: ...ates 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 ...

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