Smart Medical Device DM-VME03S Dr.Music 3s User Manual
Smart Medical Device Co.,Ltd. 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: +82-70-7525-2104, Fax: 82-504-983-1173
Website: Http://www.smd21.com
E-mail: sales@smd21.com
© 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 Device.
• 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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SMD-IFUE-DMV-001 Rev 0 3
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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SMD-IFUE-DMV-001 Rev 0 9
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 Introductions
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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
Type of Pr otecti on
ag ainst electri c sh ock
Internally Powered Rating (100 mAh)
Degree of protection
ag ainst applied par t s
TYPE BF APPLI ED PARTS
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
①Main 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)
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SMD-IFUE-DMV-001 Rev 0 37
C. Technical specification about network connection of PEMS including security features
①Dr.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.
②Specification 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 Dr.MUSIC 3s 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 provides the other information such as circuit diagrams, par ts and
description that is needed to repair the product when the ser vice
personnel are required.
Tel: +82-70-7525-2104 E-Mail: sales@smd21.com
Homepage: http://www.smd21.com
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)
Guidance and Manufacturer ’s Declaration - Electromagnetic Emissions – This
device is intended for use in the electromagnetic environment specified below.
The user of this device sh ould make sure it is used in such an environm ent.
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 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3 Vrms
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)
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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