JMS TPM-02 Instructions For Use Manual

Tongue pressure measurement device

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INSTRUCTIONS FOR USE

JMS Tongue Pressure Measurement Device

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

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PACKING CONTENT ························································································································ EN-9

BATTERIES ···································································································································· EN-9

DIRECTIONS FOR USE

NORMAL MEASUREMENT ·············································································································· EN-10

MEASUREMENT CONNECTED WITH A PARSONAL COMPUTER ························································· EN-13

AUTO SAVE FUNCTION ················································································································· EN-13

MAINTENANCE AND INSPECTION

DAIRY MAINTENANCE ··················································································································· EN-14

DAIRY INSPECTION ······················································································································ EN-14

MAINTENANCE BY DISTRIBUTOR ··································································································· EN-15

REPLACEMENT FREQUENCY AND TIMING ······················································································ EN-15

DISPOSAL INFORMATION ·············································································································· EN-15

TROUBLESHOOTING

ERROR INDICATION ······················································································································ EN-16

TROUBLESHOOTING ···················································································································· EN-17

EMC INFORMATION ·········································································· EN-18

WARRANTY AND DISCLAIMERS ························································ EN-20

WARRANTY ································································································································· EN-20

DISCLAIMERS ······························································································································ EN-20

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EN-1

Table of Contents

Troubleshooting

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Summary of Contents for JMS TPM-02

Page 1: Table Of Contents
INSTRUCTIONS FOR USE 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 ················································································································...
Page 2: Introduction
INTRODUCTION 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.
Page 3: Contra-Indications And Cautions
CONTRA-INDICATIONS AND CAUTIONS CONTRA-INDICATIONS Reuse of the Tongue Pressure Probe is prohibited. Replace for each measurement to avoid measurement errors or infection. ■ Precautions for use CAUTIONS As the device is a measuring device, it should not be used for definite diagnosis such as the assessment for swallowing function.
Page 4 ■ Storage method and validity period CAUTIONS 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℉) ・...
Page 5: Device Description
DEVICE DESCRIPTION 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.
Page 6: Device Specifications
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 DC 3V (Two AA alkaline batteries) Voltage DC 2.4V (Two AA nickel-metal-hydride rechargeable batteries)
Page 7 2． LCD screen 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. ※...
Page 8 ■ Tongue Pressure Probe (Accessory) Tongue Pressure Probe receives tongue pressure during measurement. (single use only). Balloon Hard ring Receives tongue pressure by compressing Lightly holds the diagonal part with between tongue and palate. the front teeth to position the balloon Material: Thermoplastic styrenic elastomer on the tongue.
Page 9: Preparation
PREPARATION 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) The supplied batteries are for trial use only.
Page 10: Directions For Use
DIRECTIONS FOR USE NORMAL MEASUREMENT Measurement preparation Screw without gap 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.
Page 11 Measuring 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.
Page 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. Hard palate Balloon ...
Page 13: Measurement Connected With A Parsonal Computer
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.
Page 14: Maintenance And Inspection
MAINTENANCE AND INSPECTION DAILY MAINTENANCE ■ Digital Tongue Pressure Meter Turn the power off and remove the batteries. Wipe the dirty area with a soft and dry cloth. For stubborn dirt, soak the cloth in water and a neutral detergent, wring well, and then wipe the dirt off.
Page 15: Maintenance By Distributor
MAINTENANCE BY DISTRIBUTOR We perform maintenance and inspections described below. Contact your supplier for more information. Item Frequency Inspection details Periodic Check the internal pressure adjustment accuracy and measurement accuracy with special jigs Once a year inspection and measuring instruments, and perform periodic adjustments and repairs. REPLACEMENT FREQUENCY AND TIMING Exchange frequency Replacement part...
Page 16: Troubleshooting
TROUBLESHOOTING ERROR INDICATION If an error occurs during use, the error message shown below appears. Error indicator Cause Corrective action <Pressurization error> If any of the connections are loose, reconnect them Each component is not connected properly. correctly. (See page EN-10.) A broken Tongue Pressure Probe or the Replace with new Tongue Pressure Probe or new Connecting Tube was used.
Page 17: Troubleshooting
TROUBLESHOOTING Phenomenon Cause Corrective action Check the connection of each part. If not, connect Each component is not connected properly. properly. (See page EN-10.) Internal pressure adjustment A broken Tongue Pressure Probe or a Replace with new Tongue Pressure Probe or takes time.
Page 18: Emc Information
EMC INFORMATION 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.
Page 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.
Page 20: Warranty And Disclaimers
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;...