Smart Medical Device Dr.MUSIC 3s 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.

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2.5. Layout of Dr.MUSIC 3s APP

No.

Name

Description

①

Status Display

Display the title and status icons.

②

Connect control

Control the connection to the device.

③

Output intensity control

Control and display the output intensity of the
stimulation.

④

Contents area

- Change the operation mode.

- Display the using time, low frequency wave form and
etc.

⑤

Operation control

Control the operation and choice the low frequency
wave form.

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3.1 Precautions before using

3.2 Using the device alone

3.3 Using the device with Mobile APP

3.4 Charging the device

Chapter 3.

Operating the Dr.MUSIC 3s

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3. Operating the Dr.MUSIC 3s

3.1. Precautions before using

 Read and understand all instruction in this manual before attempting to use.

 It may be occurred incidental, or consequential damages by not complying with the content

of the User’s Manual.

 Maintain the distance within 5m between the Dr.MUSIC 3s and connected Mobile phone.

 Recommended usage time is three times a day by each region. (one time: less than 30

minutes) It may cause burns to the skin when used beyond the recommended usage time. If

you don't use this device for a long time, check the operation before using.

 Large movement makes electrodes separated from the skin.

 Make sure that skin you want to place the electrodes on looks healthy and is free from

wounds or rashes.

 The skin you want to place the electrodes on must be dry, clean and free from cream or

lotion.

 Dirt, grease or particles left on the skin may lodge themselves in the hydrogel of the

electrodes.

 The shelf life of electrodes is 2 years. Check the packaging for the use-by date prior to use.

Do not electrodes whose use-by date has expired.

 Regardless of shelf-life, replace the electrodes if;

• Electrodes are damaged or torn.

• If electrodes are not attached to skin.

• If the clothes are attached to skin along with electrode.

• Stimulation feels less strong.

• When stimulation is uncomfortable.

(i.e. you should replace the electrodes, If you feel irritation or tingling in the sting away.)

※ Always replace the electrodes with electrodes recommended for this device by the

manufacturer.

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※ Available to purchase on the website (http://www.smd21.com/). Or contact a customer

service center.

 The effects of loosened electrodes

- If the electrodes are not properly attached to the skin, it may not be able to operate the

device.

- If the electrodes are not properly attached to the skin, current flow is concentrated can

cause burns.

 If there is a change in performance, stop using the device immediately and please contact

us by visiting the website (http://www.smd21.com/).

 Electrodes placement guide

※ This is only a recommendation.

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CAUTION

• Individuals with active implantable medical devices such as pacemakers, or essential

support devices such as patientmonitoring systems, must not use this equipment.

• Yon can get an electric shock when water intrusion into the product.

• You can be the cause of the product failure when water intrusion into the product.

• Do not measure in a wet state.

• If you feel the problem or feel discomfort during use, please stop using it immediately.

• Do not use in high temperature or the bathrooms during bathing.

• You should not give another electrode to another person during use. Depending on the

intensity can cause strong electrical shock to the body.

• To move the electrode during use in other parts of the body, you must first turn off the

power of the product. Depending on the strength, It will be may result in a strong electric

shock to the body.

• If electrodes lost their adhesive strength, never attach on the skin by using tape.

• When using an electrode near the chest, there is a risk of ventricular fibrillation can be increased.

• Do not stimulate through the head or the eyes directly or chest or the front of the neck

(especially the carotid arteries) or do not cross stimulation on the heart.

• Do not stimulate while you cover the mouth.

WARNING

• Please check for any physical damage of the exterior, including cracks and foreign

materials before using the product.

• You have to remove the electrodes from the skin after using. If you attach a long time,

it can cause skin problems.

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3.2. Using the device alone

(1) Plug the Detachable Connector from the micro-USB

socket.

(2) Connect the electrodes with electrode connector

(3) Place the electrodes on the part at the place you want to

treat such as shoulder, leg, arm etc.

(4) Long press the Power/Mode Button( ) to power

on the device.

※ When device turn on, the middle LED is blinking as

White.

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(5) Press lightly the Power/Mode Button( ) to select mode.

(a) There are three modes; (Music sync), (Tapping),

(Massaging)

(b) Order of changing mode are as follows;

(Music sync)→ (Tapping) → (Massaging)

※ The orange LED is lighting at each position of selected mode.

(6) After selecting mode, use by adjusting the intensity of low

frequency stimulus using intensity button( ).

(a) The operation time is 20 minutes.

(b) There run the basic program that is built in each

modes.

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

1st LED( ) is lit : 0 to 11 grades

2nd LED( ) is lit: 12 to 23 grades

3rd LED( ) is lit: 24 to 35 grade

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(7) When press the Power/Mode Button( ), operation

is stop.

Press the Intensity button( ), operation is

started from the beginning.

(8) Long press the Power/Mode Button( ) of device.

* If you do not operate within 5minutes, the device

switches off automatically.

(9) Pull the electrodes to detach from skin.

(10) Separate the electrodes from device.

(11) Stored electrodes by attaching on the holder to keep water of

gel.

* Do not place the electrodes on top of each other or so close to

each other that they touch each other.

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3.3. Using the device with Mobile APP

3.3.1. APP Download

– Install the Android APP

(1) Check whether supported device or

not. (≥ Android 4.3)

(2) Run the APP store.

(3) Press the search.

(4) Type the 'Dr.MUSIC3' in search.

(5) Install the APP.

(6) Run the APP 'Dr.MUSIC3'.

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- Install the iOS APP

(1) Check whether supported device or

not. (≥ iOS 7)

(2) Run the APP store.

(3) Press the search.

(4) Type the 'Dr.MUSIC3' in search.

(5) Install the APP.

(6) Run the App 'Dr.MUSIC3'

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3.3.2. Using the device with Mobile APP

(1) Plug the Detachable Connector from the micro-USB

socket.

(2) Connect the electrodes with electrode connector.

(3) Place the electrodes on the part at the place you want to

treat such as shoulder, leg, arm etc.

(4) Long press the Power/Mode Button( ) to power

on the device.

(5) After turn on the Bluetooth of mobile platform, run the Mobile APP.

(6) Pair the device with Mobile APP.

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→ →

<1st screen after running

APP>

<Connection list>

<1st screen after

connecting device>

(7) Press the button “Connect Touch”.
(8) Touch the “Dr. MUSIC 3s” at list.
(9) Activate the mode.
(You can select the mode among Music Sync Mode, Tapping Mode and Massaging Mode.)

- Music Sync Mode

① Touch the 'Music Sync mode’ button ( ).

② After touching the 'Music list button ( )'

select music.

③ If you want to start again, you touch the

start button ( ).

④ When starting music, adjust the intensity of

low frequency stimulus using the Intensity
Button ( ).

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⑤ If you want to stop or pause, you touch the

pause button ( ).

⑥ If you want to start again, you touch the

start button ( ).

※ Touch the 'TIME' button to setting the
operation time. (Setting time: 5 to 30 min,
Basic Setting time: 20 min)

- Tapping Mode

① Touch the ‘Tapping mode’ button ( ).

② After touching the ‘Tapping list’ button ( ),

select the program.

③ Touch the ‘Start’ button ( ).

④ Adjust the intensity of low frequency

stimulus using the Intensity Button (

).

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⑤ If you want to stop or pause, you touch the

pause button ( ).

⑥ If you want to start again, you touch the

start button ( ).

※ Touch the 'TIME' button to setting the

operation time. (Setting time: 5 to 30 min,
Basic Setting time: 20 min)

- Massaging Mode

① Touch the ‘Massaging mode’ button ( ).

② After touching the ‘Massaging list’ button

( ), select the program.

③ Touch the ‘Start’ button ( ).

④ Adjust the intensity of low frequency

stimulus using the Intensity Button (

).

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⑤ If you want to stop or pause, you touch the

pause button ( ).

⑥ If you want to start again, you touch the

start button ( ).

※ Touch the 'TIME' button to setting the
operation time. (Setting time: 5 to 30 min,
Basic Setting time: 20 min)

- Mode & Program

Mode & Program Name

Frequency

Pulse Width

Pre-set time

Using the device alone

Music Sync Mode

2Hz, 8Hz

50 µs

20min

Tapping Mode

2-10Hz

50µs

20min

Massaging Mode

5-100Hz

50-88µs

20min

Using the device with

mobile APP

Total Music Sync

1-100Hz

50-150µs

20min

Total Tapping

2-10Hz

50µs

20min

Intensive tapping

2Hz,10Hz

50µs

20min

Smooth tapping

3Hz,5Hz

50µs

20min

Wave tapping

2-10Hz

50µs

20min

Total Massaging

5-100Hz

50-88µs

20min

Intensive Massaging

100Hz

50µs

20min

Smooth Massaging

80Hz

80µs

20min

Wave Massaging

5Hz,100Hz

50-88µs

20min

* When you switch to another program during using, the intensity is automatically reset to 0. This is a

safety measure. The intensity level of the previous program may be too high for the new program.

- Check record

(1) Touch the ‘Record’ button ( ) at top

left.

(2) Check the record.

- Mode

- Program

- Intensity

- Time

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- Setting

(1) Touch the ‘Setting’ button ( ) at top right.
(2) Check the Basic information.

- APP Information

- Send e-mail

- User’s Guide

(3) Set the save record.

- Record store presence.

- The time range used record stores.

- APP User Guide

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- System OFF

(1) The 'Dr.MUSIC3' APP is terminated depending on how the APP

quit at mobile phone.

(2) Long press the Power/Mode Button( ) of device.

(3) Pull the electrodes to detach from skin.

(4) Separate the electrodes from device.

(5) Stored electrodes by attaching on the holder to keep

water of gel.

* Do not place the electrodes on top of each other or so close to

each other that they touch each other.

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3.4. Charging the device

3.4.1. Precautions for charging the device

• Treatment is not possible when the device is charging.

• Only use this device with the adapter, cord and accessories recommended by the

manufacturer.

• Charge using a compatible Micro 5pin USB cable.

• Micro 5pin USB cable or a charge adapter (DC5V, more than 1A) is products for sold

separately. Charge by using the certified products.

• Charging the device takes approx. 3 hours at room temperature.

• When the rechargeable battery is fully charged, it contains sufficient energy for approx.8

hours of continuous use under normal operating conditions.

• When the device is stored during prolonged, Keep state of battery from 40( ) to 60( )%

after removing control part.

• Do not store in the car that is exposed to direct sunlight.

• When the battery part of device become inflated or hot during charging, please dispose

of it immediately.

• When disposing of the Battery, please dispose completely discharged.

• Years of battery replace (It will replace the battery part of device.): 3 years (Charging time:

more than 3 hours, Discharge time: If the device is operated less than 8 hours.)

• Discharge cycles: About 300 times (2400Hours / 8Hours)

• Display the battery level

 Using the device alone

: If the Blue LED is blinking, the remaining time is approximately 5 minutes. Please

recharge.

 Using the device with Mobile App

: When less than 5% in accordance with the display the battery level, please recharge.

Battery/Bluetooth

Indicator

battery remains

100 %

80 %

60 %

40%

20%

5%

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3.4.2. Charging the device

(1) Unplug the Detachable Connector from the micro-

USB socket.

(2) Insert the charging cable into the micro-USB socket

of the device.

(3) The battery indicator is solid orange during charging.

(4) When the battery is fully charged, the battery

indicator turns solid green.

(5) When complete charging the device, plug the

Detachable Connector from the micro-USB socket.

* Micro-USB cable is used for charging only.

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

SMD-IFUE-DMV-001 Rev 0 34

4.1 Specification of Dr.MUSIC 3s

4.2 Specification of External Device connection

4.3 Questions about Equipment

4.4 Maintenance

4.5 EMC(Electro-Magnetic Compatibility)

4.6 FCC(Federal Communications Commission)

4.7 Marking plate

Chapter 4.

Maintenance and Information of Dr.MUSIC 3s

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

SMD-IFUE-DMV-001 Rev 0 35

4. Maintenance and Information of Dr.MUSIC 3s

4.1. Specification of Dr.MUSIC 3s

Typ e o f Pr o te c ti on

ag a in st ele ct r i c s h oc k

Internally Powered Rating (100 mAh)

Deg re e o f p ro t ec ti o n

ag a in st app li e d par ts

TY PE BF A P PLI ED PA RTS

Internally Powered Rating

3.7Vd.c.(Li-Polymer), 400 mAh

Charging Voltage

DC 5V, 1A

Applied part

Electrode

Input Device

Power/Mode Button, Intensity Button

Operation time

Using the device alone :

20min (FIXED)

Using the device with

Mobile APP :

5~30min

(Default: 20min)

Output voltage

The output stage is from 0 to 35.

Whenever increases the output intensity by one, The

output voltage is increased 1Vpk.

Starting from 4Vpk at Stage 1, finally maximum output

voltage is 38Vpk at 35 stages.

* Rated load resistance: 500Ω

Dimension

56(W)㎜×56(D)㎜×12.8(H)㎜

Length of cable : 200mm

Electrode(BWX4500, YXN45AX) : Ø45mm

Equipment Weight

54.5g

Transportation and Storage

environment

Temperature range

-25 ~ 70℃

Relative humidity

10~93%R.H. (non-condensing)

Atmospheric pressure

700 ~ 1060 hPa

Operating environment

Temperature range

5℃ ~ 40℃

Relative humidity

15~93% R.H. (non-condensing)

Atmospheric pressure

700 ~ 1060 hPa

Classification

- For continuous operation.

- Not suitable for use in the presence of flammable

anesthetics.

- Not for use in the presence of an oxygen-enriched

atmosphere (oxygen tent).

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

SMD-IFUE-DMV-001 Rev 0 36

4.2. Specification of External Device connection

A. Connectable devices

Name

Description

Bluetooth

The data for controlling the device is transmitted to the device from the

APP and the data indicating the status of the device is transmitted to the

APP from the device

* Here by, SmartMedicalDevice Co.,Ltd. declares that this DM-VME03S is in compliance

with the essential requirements and other relevant provisions of directive 1999/5/EC.

B. The required properties of the Interface and IT- network that combines PEMS

① Main Device/ Mobile APP interface

- Data format: Bluetooth

- Device status information: Read Channel & Notify Channel (0000fff4)
Device information (Bringing information when connecting to BLE)
Battery information (Receiving information periodically)

- CMD to Device –Write Channel(0000fff1)

Mode Change – Music sync/ Tapping/ Massaging
Operation Control – Start, Pause
Intensity Control – Level Control

- Data to Device – Data Channel (0000fff3)

Transmits the music to the energy level (16Level)

- Notify Channel for the transmission from the device to the smart phone

If the low frequency electrode away from the user's skin while the low-frequency output

Emergency stop - 255(FF) transfer (Pad open, Electrode separation)

Emergency stop by user while the low-frequency output

Emergency stop - 254(FF) transfer (Stopped by user)

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

SMD-IFUE-DMV-001 Rev 0 37

C. Technical specification about network connection of PEMS including security features

① Dr.MUSIC 3s APP program is designed to not-affect by an external virus infiltration. But if

infected with virus, Operating System may be a loss of storage data. Therefore, in the case
of virus infection it should be operated by an antivirus program.

② Specification of Network connection

Communication protocol: The protocol between the main unit and the mobile app is a
BLE central (Mobile) – peripheral (main unit) communications and they communication
with security requirements defined in the BLE Protocol Stack.

D. PEMS, the intended flow of information between the IT-Network and other devices

combined with the IT-Network. Intended route via the IT-Network

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

SMD-IFUE-DMV-001 Rev 0 38

E. When D r.MUSIC 3 s IT-Network connections, recommendations for responsible

Organization.

The following recommendations should be carried out under the responsibility of the

person/institution for connecting to a network.

1) All cleaning and disinfection procedures perform in accordance with the document.

2) Connection of the Dr.MUSIC 3s to an IT-Network that includes other equipment could

result in previously unidentified risks to patient, operator or third parties.

3) The users should identify, analyze, evaluate and control these risks.

4) Subsequent changes to the IT-Network could introduce new risks and shall require

additional analysis

* Change to the IT-Network includes:

∙ Changes in the IT-Network configuration;

∙ Connection of additional items to the IT-Network.

∙ Disconnecting items from the IT-Network.

∙ Update of equipment connected to the IT-Network.

∙ Upgrade of equipment connected to the IT-Network

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

SMD-IFUE-DMV-001 Rev 0 39

4.3. Questions about Equipment

Questions

Answers

Q1) The treatment feels

different or less pleasant

than usual.

A1) If the intensity is Too high or too low, you will

be felt different or less pleasant than usual.

You should control the intensity button or

change the mode.

A2) If the electrodes are not properly attached, you

will be felt different or less pleasant than usual.
Check if the electrodes are attached to the skin
properly.

A3) The electrodes are worn, Replace the electrodes.

Q2) The output level is not

changed.

A1) Check if the electrodes are attached to the skin

properly.

Q3) During using, stimulus is

output but Blue LED is

flashing.

A1) The battery is low, Charge the battery.

Q4) The electrodes do not

attach to the skin.

A1) The electrodes are worn, Replace the electrodes.

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

SMD-IFUE-DMV-001 Rev 0 40

4.4. Maintenance

4.4.1. Cleaning Plan

ITEM

Method

Period

Check

Contamination and damage inspection of the

appearance.

Check before use.

Cleaning

Refer to Section 4.4.2 “Cleaning & Storage”

Clean after use.

4.4.2. Cleaning & Storage

• Clean it with a dry towel.

• If the electrodes are dirty, put a drop of water on your finger and gently rub the dirt off

the surface.

• Storage the product specified environment cited under chapter 4.1 Specification of

Dr.MUSIC 3s.

WARNING

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 malfunction.

CAUTION

• Do not use abrasive or solvent-based cleaners.

• Do not expose the product to extremely high or low temperature.

• Do not leave the product in direct sunlight for an extended period of time.

• Do not immerse the device in water or rinse it under the tap.

• Do not immerse the electrodes in water.

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

SMD-IFUE-DMV-001 Rev 0 41

4.4.3. Replacing the Battery

 If the shelf life of battery is end, contact us and purchase the battery part.

 It pro vi des th e o th e r i nfo rm ati on suc h a s c irc uit di ag ram s, pa rt s a nd

des cri pt ion th at i s need ed to repa ir the pro duc t whe n th e ser vi ce
per so nne l are req ui r ed.

Tel: [phone] E -M ai l: sal es @sm d2 1.c om

Hom epa ge: h ttp :/ /ww w. sm d 21 .co m

WARNING

 Only the trained service personnel of the manufacturer will carry out the repair service.

 Do not disassemble or modify the equipment including internal parts without written

consent from the manufacturer. This may cause electric shock or injury, product

malfunction, inaccurate results, and will void the manufacturer’s warranty.

 The minimum qualifications for SERVICE PERSONNEL.

- Service and Installation trained service personnel.

- Only personnel read the instruction manual or received training to use.

4.4.4. Expected service life

The Dr.MUSIC 3s has an expected service life of 3 years. To maintain the condition of the

device have the device maintained regularly according to the schedule recommended by

manufacturer.

4.4.5. Disposal

The device described in this manual must be disposed of in compliance

with the applicable local waste control regulations at the end of their

service life. If you have questions regarding the disposal of the device,

please contact the manufacturer or an authorized disposal company.

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

SMD-IFUE-DMV-001 Rev 0 42

4.5. EMC(Electro-Magnetic Compatibility)

Gui dan ce an d M anu fa ctu rer ’s De c la r at ion - E le c tro ma g ne ti c Em is s io ns – Th is
de v ic e i s i nte n de d f or us e i n t he el ect rom agn et ic en v ir o nme nt sp eci fi e d bel ow.
The us er of th i s d ev ic e s h ou ld ma k e s ure it i s u sed in s u ch an en vi r onm en t .

Emissions Test

Compliance

Electromagnetic Environment- Guidance

RF emissions CISPR 11

Group 1

The device uses RF energy only for its internal
function. Therefore, its RF emissions are very low
and are not likely to cause any interference in
nearby electronic equipment.

RF emissions
CISPR 11

Class B

The device is suitable for use in all
establishments, including domestic
establishments and those directly connected to
the public low-voltage power supply network.

Harmonic emissions
IEC 61000-3-2

Class A

Voltage fluctuations/Flicker
emissions
IEC 61000-3-3

Complies

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity – This device is intended for
use in the electromagnetic environment specified below. The user of this device should make sure
it is used in such an environment.

Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic

Environment- Guidance

Electrostatic
discharge (ESD)
IEC 61000-4-2

± 6 kV contact
± 8 kV air

± 6 kV contact
± 8 kV air

Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30 %.

Electrical fast
transient/burst
IEC 61000-4-4

± 2 kV for power
supply lines

± 1 kV for

input/output
lines

± 2 kV for supply
mains

± 1 kV for

input/output
lines

Mains power quality should
be that of hospital
environment.

Surge
IEC 61000-4-5

±1 kV differential
mode

±2 kV common mode

±1 kV differential

mode
±2 kV for
common mode

Mains power quality should
be that of hospital
environment.

Voltage dips,
short

<5 % UT
(>95 % dip in UT)

<5 % UT
(>95 % dip in UT)

Mains power quality should
be that of hospital

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

SMD-IFUE-DMV-001 Rev 0 43

interruptions
and
voltage
variations
on power supply
input lines
IEC 61000-4-11

for 0.5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT) for 5
s

for 0.5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 s

environment. If the user of
the device requires
continued operation during
power mains interruptions,
it is recommended that the
device be powered from an
uninterruptible power
supply or a battery.

Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8

3 A/m

3 A/m

Power frequency magnetic
fields should be at levels
characteristic of a typical
location in hospital
environment.

NOTE: UT is the ac. mains voltage prior to application of the test level.

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity – This device is intended for
use in the electromagnetic environment specified below. The user of this device should make sure
it is used in such an environment.

IMMUNITY

test

IEC 60601 TEST

LEVEL

Compliance

level

Electromagnetic environment – guidance

Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3

3 V

rms

150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz

3 V

rms

3 V/m

Portable and mobile RF communications
equipment should be used no closer to
any part of the device, including cables,
than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance

d = 1.2 √𝑃

d = 1.2 √𝑃80MHz to 800 MHz
d = 2.3 √𝑃800MHz to 2.5 GHz

Where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site

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

SMD-IFUE-DMV-001 Rev 0 44

surveya, should be less than the
compliance level in each frequency rangeb.
Interference may occur in the vicinity of
equipment marked with following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.

a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones 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 to 80 MHz, field strengths should be less than 3 V/m.

Recommended Separation Distances between Portable and Mobile RF Communications Equipment
and This Device: The device is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of this device can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and this device as recommended below, according to
the maximum output power of the communications equipment.

Rated maximum

output power of

transmitter, W

Separation distance according to frequency of transmitter, M

150 kHz to 80 MHz

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 d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.

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

SMD-IFUE-DMV-001 Rev 0 45

4.6. FCC(Federal Communications Commission)

This equipment has been tested and found to comply with the limits for a class B digital device,

pursuant to Part 15 of the FCC Rules. These Limits are designed to provide reasonable

protection against harmful interference in a residential installation.

This equipment generates uses and can radiate radio frequency energy and, if not installed and

used in accordance with the instructions, may cause harmful interference to radio

communications.

However, there is no guarantee that interference will not occur in a particular installation. If this

equipment does cause harmful interference to radio or television reception, which can be

determined by turning the equipment off and on, the user is encouraged to try to correct the

interference by one or more of the following measures:

- Reorient or relocate the receiving antenna.

- Increase the separation between the equipment and receiver.

- Connect the equipment into an outlet on a circuit different from that to which the receiver is

connected.

- Consult the dealer or an experienced radio/TV technical for help.

WARNIG: This equipment may generate or use radio frequency energy. Changes or modifications

to this equipment may cause harmful interference unless the modifications are

expressly approved in the instruction manual. The user could lose the authority to

operate this equipment if an unauthorized change or modification is made.

This device complies with Part 15 of the FCC’s Rules. Operation is subject to the following two

conditions:

1. This device may not cause harmful interference, and

2. This device must accept ant interference received, including interference that may cause

undesirable operation.

This device complies with rf exposure requirement.

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

SMD-IFUE-DMV-001 Rev 0 46

4.7. Marking plate

 Trademark: Dr.MUSIC 3s

 Model: DM-VME03S

• Position of label: the back side of Control part

• Label of device

• Position of box label: the bottom side of outer box

• Box label