Smart Medical Device DM VME03S User Manual

Dr.MUSIC 3s

(Model: DM-VME03S)

SmartMedicalDevice Co.,Ltd.

#803, 32-19, Gobong-ro, Ilsandong-gu, Goyang-si

Gyeonggi-do, Korea

Tel: [phone], Fax: [phone]

Website: Http://www.smd21.com

E-mail: [e-mail]

© 2016.SmartMedicalDevice Co.,Ltd.

All rights reserved. Reproduction in whole or in part in any form or by any means, electrical,

mechanical or otherwise is prohibited without the written consent of the copyright holder.

Manual status: SMD-IFUE-DMV-001 (ver. 0), Date of preparation: 16/03/15

User ’s Manual

Dr.MUSIC 3s (Model: DM-VME03S)

SMD-IFUE-DMV-001 Rev 0 2

About this manual

• Read and understand all instruction in this manual before attempting to use the D ev ice .

• SmartMedicalDevice Co., Ltd. shall not be liable for any incidental, or consequential damages

that occurred by not complying with the content of the User’s Manual.

• Assist user in the safe and effective operation of the product.

• Explains procedures for the product setup, control and function.

• Keep this manual with the product.

• Content of this manual may be changed or improved.

• All references to standards / regulations and their revisions are valid for the time of

publication of this instruction for use.

• The screen graphics and illustrations in this manual are for illustrative purposes only and may

be different from what is displayed on the screen or device.

Conventions

Throughout the text in these instructions for use, warnings and other information essential when

using this unit, such as cautionary or prohibited items, appear classified as per the following.

Mark

Description

WARNING

Warning indicates a hazardous situation which, if not avoid, may

result in death or serious injury.

CAUTION

Caution indicates a hazardous situation which, if not a avoided, may

result in minor or moderate injury.

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Symbol

Symbol

Description / Function

Reference

Refer to instruction manual/ booklet.

ISO 7010:2012-M002

General prohibition sign

ISO 7010:2012-P001

EU-Warning: This symbol indicates hazard.
If not avoided, the hazard can result death or serious injury.

ISO 7010:2012-W001

EU- Caution: This symbol indicates hazard.
Minor personal injury or product damage.

ISO 7000:2014

No access for people with active implanted cardiac devices.

ISO 7010-P007

This symbol on the device means: Protected against solid
foreign objects of 12,5 mm φand greater and
against vertically falling water drops when tilted up
to 15 degrees.

IEC60529
Manufacturer information: This symbol is followed by the

name and address of the device manufacturer.

ISO 15223-1:2012

Manufacture Date: This symbol is followed by the device
manufacture date in the form YYYY-MM.

ISO 15223-1:2012

Serial Number: This symbol is followed by the device serial
number.

ISO 15223-1:2012

This symbol means: Conforms to EC Directives.
CE stands for ‘Conformité Européenne’.

-

Authorized representative in the European community.

EN ISO 15223-1:2012

Electrical protection: Insulated patient application(TYPE BF)

IEC 60417-1:2002

EU-Electronics and Battery Disposal Information:
This symbol means that the product and battery should be
recycled separately from household waste.”

-

“ON/OFF” (power)

IEC 60417-1:2002

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Direct current

IEC 60417-1:2002

This symbol means that this device emits non-ionising
radiation.

-

This is the battery symbol. It appears next to the battery
indicator.

-

Bluetooth

-

This device conforms to the following international standards:

• IEC 60601-1:2012 Electrical medical equipment

• IEC 60601-1-2:2014 Electromagnetic compatibility

• IEC 60601-1-6:2013& IEC 62366:2014 Usability safety

• IEC 60601-1-11:2010 Home Healthcare Environment

• IEC 60601-2-10:2012 Nerve and muscle stimulators

• IEC 62304:2006 Software life cycle processes

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Contents

1. SAFETY INFORMATION ......................................................................................................... 7

1.1. CONTRAINDICATIONS .............................................................................................................. 7

1.2. GENERAL SAFETY ..................................................................................................................... 8

2. DR.MUSIC 3S INTRODUCTION .......................................................................................... 11

2.1. OPERATING PRINCIPLE ........................................................................................................... 11

2.2. INTENDED USE ....................................................................................................................... 11

2.3. PRODUCT COMPONENTS ....................................................................................................... 12

2.4. EXTERIOR AND FUNCTION ..................................................................................................... 13

2.5. LAYOUT OF DR.MUSIC 3S APP ........................................................................................... 15

3. OPERATING THE DR.MUSIC 3S ......................................................................................... 17

3.1. PRECAUTIONS BEFORE USING ................................................................................................ 17

3.2. USING THE DEVICE ALONE ..................................................................................................... 20

3.3. USING THE DEVICE WITH MOBILE APP ................................................................................. 23

3.4. CHARGING THE DEVICE .......................................................................................................... 32

4. MAINTENANCE AND INFORMATION OF DR.MUSIC 3S .............................................. 35

4.1. SPECIFICATION OF DR.MUSIC 3S ......................................................................................... 35

4.2. SPECIFICATION OF EXTERNAL DEVICE CONNECTION .............................................................. 36

4.3. QUESTIONS ABOUT EQUIPMENT ............................................................................................ 39

4.4. MAINTENANCE ...................................................................................................................... 40

4.5. EMC(ELECTRO-MAGNETIC COMPATIBILITY) .......................................................................... 42

4.6. FCC(FEDERAL COMMUNICATIONS COMMISSION) ................................................................. 45

4.7. MARKING PLATE .................................................................................................................... 46

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1.1 Contraindications

1.2 General safety

Chapter 1.

Safety Information

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1. Safety Information

1.1. Contraindications

Never use this product in combination with following medical electronic device:

• Active implantable medical devices such as pacemakers.

• Electronic life support system such as an artificial heart/lung.

• Portable electronic medical device such as an electrocardiograph.

Never use person that has problem as below:

• This device is not designed for use on infant or children.

• You are pregnant woman or people with the possibility of pregnancy.

• You have cardiac disorder and cardiac lesion.

• You are physically and mentally debilitating.

• You have a problem for a blood pressure.

• People with high body temperature.

• A person who uses high-frequency medical devices.

• A person who visit the hospital regularly due to venous thrombosis.

• A person with much of menstrual bleed volume.

• If after inserting the (IUD, for example; coils, rings, etc.) within one month

contraceptive in the uterus.

• Do not use the site on scar wounds, burns, infected, acne, problems related to

blood clots, other vascular (for example; venous varices), or in limited parts of the

body.

• People deemed inappropriate by a doctor.

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Patient with problem as below uses carefully and contacts a doctor:

 People with acute disease.

 People with malignant tumors.

 People with a high fever.

 People with problem on the skin of application site.

 People who recently operated on.

 People who are administered the insulin to treat diabetes.

 People who have symptom side effects such as hypersensitivity, Inflammation, skin

disorders, etc.

 People with problems in the muscles or joints.

 Within six weeks after the labour.

 People within three months after a caesarean section.

 People who want to use this device as a part of rehabilitation.

 People who received medical treatment by doctor.

 People with serious illnesses what damage has not been mentioned in this document.

1.2. General safety

 Do not modify this product without authorization of SmartMedicalDeivce Co.,Ltd.

 Pregnant women need to consult their healthcare provider before use.

 Use the product only for its intended use as described in this manual.

 Keep the user’s manual with the equipment at all times.

 Individuals with any kind of contagious disease or injury must not use or contact with this

product.

 Always operate this product within prescribed ranges of temperature, humidity and pressure.

Operating in other environments may affect the operation of this product, and may cause

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malfunction.

 Be careful not to spill or drop beverages or any other liquid on this product. It may cause

serious damage to the electronic components.

 Stop using the device and consult your doctor if you experience adverse reactions from the

device.

 Do not use concurrently with other stimulator.

 Strong magnetic line of force or electromagnetic radiation can cause failure or malfunction.

 Keep hands away from where children and pets.

 It may interfere with the normal operation of these devices when used in the presence of

electronic monitoring devices (heart monitor, ECG alarms, etc.).

 Patients that are connected to the high frequency surgery equipment is prohibited to use.

Skin may cause burns and the device may damage the equipment.

 When used within 1m from a short-wave or microwave medical equipment, Output of the

device may become unstable.

 Portable RF communications equipment (including peripherals such as antenna cables and

external antennas) should be used no closer than 30 cm(12 inches) to any part of the device

including cables specified by the manufacturer. Otherwise, degradation of the performance

of this equipment could result.

 When used the device in environments such as bathrooms, showers and swimming pools, it

may cause a risk of electric shock and burns.

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2.1 Dr.MUSIC 3s 소개

2.1 Operating principle

2.2 Intended use

2.3 Product Components

2.4 Exterior and Function

2.5 Layout of Dr.MUSIC 3s APP

Chapter 2.

Dr.MUSIC 3s Introduc tions

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2. Dr.MUSIC 3s Introduction

2.1. Operating principle

Transcutaneous electrical nerve stimulation (TENS) is a non-invasive pain relief method
for which clinical proof exists that it can help relieve pain. TENS treatment passes
electrical pulses across the intact surface of the skin to activate the underlying nerves.
The device uses a rechargeable battery to generate pulses. These pulses are applied to
the skin through self-adhesive hydrogel electrodes. You can choose the stimulation
programs with different pulse settings using Mobile App, or Device itself.

2.2. Intended use

DM-VME03S is intended to be used by adults for temporary relief of pain associated with

sore/aching muscles in the shoulder, waist, back, neck, upper extremities(arm) and lower

extremities(leg) due to strain from exercise or normal household work activities and

suitable for home use.

2.2.1. Intended user profile

Considerations

Requirement Description

Education

• Understand the instruction for the product

Knowledge

 Understand Symbols on User’s manual and App
 Read and understand User’s manual.

Language

• The display language depends on the language settings menu of
the Mobile phone.

Experience

• Able to use based android or iOS software.

• Who read through the user’s manual how to use it.

Permissible

impairments

• Mild visual impairment.

• Average degree of aging-related short term memory impairment.

This progress is required to accompany a guardian for the other users

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2.2.2. Intended patient population

Considerations

Requirement Description

Age

Adult

Gender

male and female

Health

Do not use patient that operated active implantable medical

devices (e.g., Implanted pace-maker).

Do not use on infants or patient who cannot properly expresses.

Refer to Chapter 1.1 Contraindications in this user’s manual.

Nationality

Multiple

2.3. Product Components

The Dr.MUSIC 3s consists of the following components.

Main Unit

Control part

Battery part

Electrode

Holder

 Please inspect defects of each component prior to installation.

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2.4. Exterior and Function

- Main Unit

No.

Name

Description

①

Power/Mode Button

Power ON/OFF, Change of Operating Mode.

②

Mode/Status indicator

Display mode and level, Battery status.

- Mode/Level/Output : Orange LED

- Battery: Blue LED

③

Intensity Button

Control of the level.

0 to 11 grades

12 to 23 grades

24 to 35 grades

④

Battery Indicator

Indicated the Status of the battery charging.

(Charging: Orange LED, Fully Charged: Green LED)

⑤

Micro-USB socket

Socket for the battery charging.

⑥

Detachable Connector

Connector for the cable of Micro USB adaptor.

⑦

Electrode connector

Connected output socket with electrode for Low frequency

stimulus.

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- Mode/Status Display LED

Name

Description

Mode indicator

Indicated each Status.
(ⓐ Music sync, ⓑ Tapping, ⓒ Massaging)

Intensity indicator

When adjusting the higher intensity, the LED is lighting from
left to right gradually.

output indicator

Each of LED is flashing during output.
(ⓐ Music sync, ⓑ Tapping, ⓒ Massaging)

Low battery indicator

When battery is low, ⓑ LED is flashing.

- Component

(1) Electrodes

Description

Electrodes are delivered low frequency pulse to body by attaching on the skin.

(2) Holder

Description

It is used to store the electrodes by attaching.