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) User âs Manual 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 Š 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 Dr.MUSIC 3s (Model: DM-VME03S) About this manual ⢠Read and understand all instruction in this manual before attempting to use the D e v i c e. ⢠SmartMedicalDevice Co., Ltd. shall not be liable for any incidental, or consequential damages that occurred by not complying with the content of the Userâs 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 indicates a hazardous situation which, if not avoid, may WARNING result in death or serious injury. Caution indicates a hazardous situation which, if not a avoided, may CAUTION result in minor or moderate injury. SMD-IFUE-DMV-001 Rev 0 Dr.MUSIC 3s (Model: DM-VME03S) 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. EU- Caution: This symbol indicates hazard. Minor personal injury or product damage. No access for people with active implanted cardiac devices. ISO 7010:2012-W001 ISO 7000:2014 ISO 7010-P007 This symbol on the device means: Protected against solid foreign objects of 12,5 mm Ďand greater and against vertically falling water drops when tilted up IEC60529 to 15 degrees. Manufacturer information: This symbol is followed by the name and address of the device manufacturer. Manufacture Date: This symbol is followed by the device manufacture date in the form YYYY-MM. Serial Number: This symbol is followed by the device serial number. This symbol means: Conforms to EC Directives. CE stands for âConformitĂŠ EuropĂŠenneâ. ISO 15223-1:2012 ISO 15223-1:2012 ISO 15223-1:2012 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.â âON/OFFâ (power) SMD-IFUE-DMV-001 Rev 0 IEC 60417-1:2002 Dr.MUSIC 3s (Model: DM-VME03S) 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 SMD-IFUE-DMV-001 Rev 0 Dr.MUSIC 3s (Model: DM-VME03S) 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 SMD-IFUE-DMV-001 Rev 0 Dr.MUSIC 3s (Model: DM-VME03S) Chapter 1. Safety Information 1.1 Contraindications 1.2 General safety SMD-IFUE-DMV-001 Rev 0 Dr.MUSIC 3s (Model: DM-VME03S) 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. SMD-IFUE-DMV-001 Rev 0 Dr.MUSIC 3s (Model: DM-VME03S) Patient with problem as below uses carefully and contacts a doctor: ďŹ People with acute disease. ďŹ People with malignant tumors. ďŹ People with a high fever. ďŹ People with problem on the skin of application site. ďŹ People who recently operated on. ďŹ People who are administered the insulin to treat diabetes. ďŹ People who have symptom side effects such as hypersensitivity, Inflammation, skin disorders, etc. ďŹ People with problems in the muscles or joints. ďŹ Within six weeks after the labour. ďŹ People within three months after a caesarean section. ďŹ People who want to use this device as a part of rehabilitation. ďŹ People who received medical treatment by doctor. ďŹ People with serious illnesses what damage has not been mentioned in this document. 1.2. General safety ďŹ Do not modify this product without authorization of SmartMedicalDeivce Co.,Ltd. ďŹ Pregnant women need to consult their healthcare provider before use. ďŹ Use the product only for its intended use as described in this manual. ďŹ Keep the userâs manual with the equipment at all times. ďŹ Individuals with any kind of contagious disease or injury must not use or contact with this product. ďŹ 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 SMD-IFUE-DMV-001 Rev 0 Dr.MUSIC 3s (Model: DM-VME03S) malfunction. ďŹ Be careful not to spill or drop beverages or any other liquid on this product. It may cause serious damage to the electronic components. ďŹ Stop using the device and consult your doctor if you experience adverse reactions from the device. ďŹ Do not use concurrently with other stimulator. ďŹ Strong magnetic line of force or electromagnetic radiation can cause failure or malfunction. ďŹ Keep hands away from where children and pets. ďŹ It may interfere with the normal operation of these devices when used in the presence of electronic monitoring devices (heart monitor, ECG alarms, etc.). ďŹ 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. ďŹ When used within 1m from a short-wave or microwave medical equipment, Output of the device may become unstable. ďŹ 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. ďŹ When used the device in environments such as bathrooms, showers and swimming pools, it may cause a risk of electric shock and burns. SMD-IFUE-DMV-001 Rev 0 Dr.MUSIC 3s (Model: DM-VME03S) Chapter 2. Dr.MUSIC 3s Introductions 2.1 Dr.MUSIC 3s ěę° 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 SMD-IFUE-DMV-001 Rev 0 10 Dr.MUSIC 3s (Model: DM-VME03S) 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 Education Knowledge Requirement Description ⢠Understand the instruction for the product ď Understand Symbols on Userâs manual and App ď Read and understand Userâs manual. ⢠The display language depends on the language settings menu of Language the Mobile phone. Experience ⢠Able to use based android or iOS software. ⢠Who read through the userâs manual how to use it. Permissible ⢠Mild visual impairment. impairments ⢠Average degree of aging-related short term memory impairment. This progress is required to accompany a guardian for the other users SMD-IFUE-DMV-001 Rev 0 11 Dr.MUSIC 3s (Model: DM-VME03S) 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 userâs manual. Nationality Multiple 2.3. Product Components The Dr.MUSIC 3s consists of the following components. Main Unit Control part Battery part Electrode Holder ďŹ Please inspect defects of each component prior to installation. SMD-IFUE-DMV-001 Rev 0 12 Dr.MUSIC 3s (Model: DM-VME03S) 2.4. Exterior and Function - Main Unit No. Name Description â Power/Mode Button Power ON/OFF, Change of Operating Mode. ⥠Mode/Status indicator Display mode and level, Battery status. - Mode/Level/Output : Orange LED - Battery: Blue LED ⢠Intensity Button Control of the level. 0 to 11 grades ⣠Battery Indicator 12 to 23 grades 24 to 35 grades Indicated the Status of the battery charging. (Charging: Orange LED, Fully Charged: Green LED) ⤠Micro-USB socket Socket for the battery charging. ⼠Detachable Connector Connector for the cable of Micro USB adaptor. ⌠Electrode connector Connected output socket with electrode for Low frequency stimulus. SMD-IFUE-DMV-001 Rev 0 13 Dr.MUSIC 3s (Model: DM-VME03S) - Mode/Status Display LED Name Mode indicator Description Indicated each Status. (â Music sync, â Tapping, â 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. (â Music sync, â Tapping, â Massaging) Low battery indicator When battery is low, â 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. SMD-IFUE-DMV-001 Rev 0 14 Dr.MUSIC 3s (Model: DM-VME03S) 2.5. Layout of Dr.MUSIC 3s APP No. Name â Status Display ⥠Connect control ⢠Output intensity control Description Display the title and status icons. Control the connection to the device. Control and display the output intensity of the stimulation. ⣠Contents area - Change the operation mode. - Display the using time, low frequency wave form and etc. ⤠Operation control Control the operation and choice the low frequency wave form. SMD-IFUE-DMV-001 Rev 0 15 Dr.MUSIC 3s (Model: DM-VME03S) Chapter 3. Operating the Dr.MUSIC 3s 3.1 Precautions before using 3.2 Using the device alone 3.3 Using the device with Mobile APP 3.4 Charging the device SMD-IFUE-DMV-001 Rev 0 16 Dr.MUSIC 3s (Model: DM-VME03S) 3. Operating the Dr.MUSIC 3s 3.1. Precautions before using ďŹ Read and understand all instruction in this manual before attempting to use. ďŹ It may be occurred incidental, or consequential damages by not complying with the content of the Userâs Manual. ďŹ Maintain the distance within 5m between the Dr.MUSIC 3s and connected Mobile phone. ďŹ 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. ďŹ Large movement makes electrodes separated from the skin. ďŹ 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 ďŹ lotion. Dirt, grease or particles left on the skin may lodge themselves in the hydrogel of the ďŹ electrodes. The shelf life of electrodes is 2 years. Check the packaging for the use-by date prior to use. ďŹ Do not electrodes whose use-by date has expired. Regardless of shelf-life, replace the electrodes if; ďŹ â˘ 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.) âť Always replace the electrodes with electrodes recommended for this device by the manufacturer. SMD-IFUE-DMV-001 Rev 0 17 Dr.MUSIC 3s (Model: DM-VME03S) âť Available to purchase on the website (http://www.smd21.com/). Or contact a customer service center. ďŹ 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. ďŹ If there is a change in performance, stop using the device immediately and please contact us by visiting the website (http://www.smd21.com/). ďŹ Electrodes placement guide âť This is only a recommendation. SMD-IFUE-DMV-001 Rev 0 18 Dr.MUSIC 3s (Model: DM-VME03S) 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. SMD-IFUE-DMV-001 Rev 0 19 Dr.MUSIC 3s (Model: DM-VME03S) 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. âť When device turn on, the middle LED is blinking as White. SMD-IFUE-DMV-001 Rev 0 20 Dr.MUSIC 3s (Model: DM-VME03S) (5) Press lightly the Power/Mode Button( (a) There are three modes; ) to select mode. (Music sync), (Tapping), (Massaging) (b) Order of changing mode are as follows; (Music sync)â (Tapping) â (Massaging) âť 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. âť 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 SMD-IFUE-DMV-001 Rev 0 21 Dr.MUSIC 3s (Model: DM-VME03S) (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. SMD-IFUE-DMV-001 Rev 0 22 Dr.MUSIC 3s (Model: DM-VME03S) 3.3. Using the device with Mobile APP 3.3.1. APP Download â Install the Android APP (1) Check whether supported device or (2) Run the APP store. (3) Press the search. (5) Install the APP. (6) Run the APP 'Dr.MUSIC3'. not. (⼠Android 4.3) (4) Type the 'Dr.MUSIC3' in search. SMD-IFUE-DMV-001 Rev 0 23 Dr.MUSIC 3s (Model: DM-VME03S) - Install the iOS APP (1) Check whether supported device or (2) Run the APP store. (3) Press the search. (5) Install the APP. (6) Run the App 'Dr.MUSIC3' not. (⼠iOS 7) (4) Type the 'Dr.MUSIC3' in search. SMD-IFUE-DMV-001 Rev 0 24 Dr.MUSIC 3s (Model: DM-VME03S) 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. SMD-IFUE-DMV-001 Rev 0 25 Dr.MUSIC 3s (Model: DM-VME03S) â <1st screen after running APP> â <1st screen afterconnecting device> (7) Press the button âConnect Touchâ. (8) Touch the âDr. MUSIC 3sâ at list. (9) Activate the mode. (You can select the mode among Music Sync Mode, Tapping Mode and Massaging Mode.) - Music Sync Mode â Touch the 'Music Sync modeâ button ( ). ⥠After touching the 'Music list button ( )' select music. ⢠If you want to start again, you touch the start button ( ⣠When starting music, adjust the intensity of low frequency stimulus using the Intensity ). SMD-IFUE-DMV-001 Rev 0 Button ( 26 ). Dr.MUSIC 3s (Model: DM-VME03S) ⤠If you want to stop or pause, you touch the pause button ( ). ⼠If you want to start again, you touch the start button ( ). âť Touch the 'TIME' button to setting the operation time. (Setting time: 5 to 30 min, Basic Setting time: 20 min) - Tapping Mode â Touch the âTapping modeâ button ( ). ⥠After touching the âTapping listâ button ( ), select the program. ⣠Adjust the intensity of low frequency ⢠Touch the âStartâ button ( ). stimulus using the Intensity Button ( ). SMD-IFUE-DMV-001 Rev 0 27 Dr.MUSIC 3s (Model: DM-VME03S) ⤠If you want to stop or pause, you touch the pause button ( ). âť Touch the 'TIME' button to setting the operation time. (Setting time: 5 to 30 min, ⼠If you want to start again, you touch the start button ( Basic Setting time: 20 min) ). - Massaging Mode â Touch the âMassaging modeâ button ( ). ⥠After touching the âMassaging listâ button ), select the program. ⣠Adjust the intensity of low frequency ⢠Touch the âStartâ button ( ). stimulus using the Intensity Button ( ). SMD-IFUE-DMV-001 Rev 0 28 Dr.MUSIC 3s (Model: DM-VME03S) ⤠If you want to stop or pause, you touch the pause button ( ). ⼠If you want to start again, you touch the start button ( ). âť 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 2Hz, 8Hz 50 Âľs 20min Tapping Mode 2-10Hz 50Âľs 20min Massaging Mode 5-100Hz 50-88Âľs 20min Total Music Sync 1-100Hz 50-150Âľs 20min Total Tapping 2-10Hz 50Âľs 20min Intensive tapping 2Hz,10Hz 50Âľs 20min Smooth tapping 3Hz,5Hz 50Âľs 20min Wave tapping 2-10Hz 50Âľs 20min Total Massaging 5-100Hz 50-88Âľs 20min Intensive Massaging 100Hz 50Âľs 20min Smooth Massaging 80Hz 80Âľs 20min 5Hz,100Hz 50-88Âľs 20min Music Sync Mode Using the device alone Using the device with mobile APP Wave Massaging * 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 âRecordâ button ( left. (2) Check the record. - Mode - Program - Intensity - Time SMD-IFUE-DMV-001 Rev 0 29 ) at top Dr.MUSIC 3s (Model: DM-VME03S) - Setting (1) Touch the âSettingâ button ( ) at top right. (2) Check the Basic information. - APP Information - Send e-mail - Userâs Guide (3) Set the save record. - Record store presence. - The time range used record stores. - APP User Guide SMD-IFUE-DMV-001 Rev 0 30 Dr.MUSIC 3s (Model: DM-VME03S) - 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. SMD-IFUE-DMV-001 Rev 0 31 Dr.MUSIC 3s (Model: DM-VME03S) 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 ď Using the device alone : If the Blue LED is blinking, the remaining time is approximately 5 minutes. Please recharge. ď 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 SMD-IFUE-DMV-001 Rev 0 100 % 80 % 32 60 % 40% 20% 5% Dr.MUSIC 3s (Model: DM-VME03S) 3.4.2. Charging the device * Micro-USB cable is used for charging only. (1) Unplug the Detachable Connector from the microUSB 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. SMD-IFUE-DMV-001 Rev 0 33 Dr.MUSIC 3s (Model: DM-VME03S) Chapter 4. Maintenance and Information of Dr.MUSIC 3s 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 SMD-IFUE-DMV-001 Rev 0 34 Dr.MUSIC 3s (Model: DM-VME03S) 4. Maintenance and Information of Dr.MUSIC 3s 4.1. Specification of Dr.MUSIC 3s T yp e o f Pr ote c ti o n ag ai n st e le c tri c s h o c k Degre e o f pr ote c ti o n ag ai n st a pp lie d par t s Internally Powered Rating Internally Powered Rating (100 mAh) T Y PE BF A PPL I ED PA RTS 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 5~30min Mobile APP : (Default: 20min) The output stage is from 0 to 35. Whenever increases the output intensity by one, The Output voltage output voltage is increased 1Vpk. Starting from 4Vpk at Stage 1, finally maximum output voltage is 38Vpk at 35 stages. * Rated load resistance: 500Ί 56(W)ăĂ56(D)ăĂ12.8(H)ă Dimension Length of cable : 200mm Electrode(BWX4500, YXN45AX) : Ă45mm Equipment Weight Transportation and Storage environment Operating environment 54.5g Temperature range -25 ~ 70â Relative humidity 10~93%R.H. (non-condensing) Atmospheric pressure 700 ~ 1060 hPa Temperature range 5â ~ 40â Relative humidity 15~93% R.H. (non-condensing) Atmospheric pressure 700 ~ 1060 hPa - For continuous operation. - Not suitable for use in the presence of flammable Classification anesthetics. - Not for use in the presence of an oxygen-enriched atmosphere (oxygen tent). SMD-IFUE-DMV-001 Rev 0 35 Dr.MUSIC 3s (Model: DM-VME03S) 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 â 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 âWrite Channel(0000fff1) Mode Change â Music sync/ Tapping/ Massaging Operation Control â Start, Pause Intensity Control â Level Control - Data to Device â 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 -ď 255(FF) transfer (Pad open, Electrode separation) Emergency stop by user while the low-frequency output Emergency stop -ď 254(FF) transfer (Stopped by user) SMD-IFUE-DMV-001 Rev 0 36 Dr.MUSIC 3s (Model: DM-VME03S) C. Technical specification about network connection of PEMS including security features â 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. ⥠Specification of Network connection Communication protocol: The protocol between the main unit and the mobile app is a BLE central (Mobile) â 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 SMD-IFUE-DMV-001 Rev 0 37 Dr.MUSIC 3s (Model: DM-VME03S) 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: â Changes in the IT-Network configuration; â Connection of additional items to the IT-Network. â Disconnecting items from the IT-Network. â Update of equipment connected to the IT-Network. â Upgrade of equipment connected to the IT-Network SMD-IFUE-DMV-001 Rev 0 38 Dr.MUSIC 3s (Model: DM-VME03S) 4.3. Questions about Equipment Questions Answers 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 Q1) The treatment feels different or less pleasant than usual. 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 A1) The battery is low, Charge the battery. flashing. Q4) The electrodes do not attach to the skin. SMD-IFUE-DMV-001 Rev 0 A1) The electrodes are worn, Replace the electrodes. 39 Dr.MUSIC 3s (Model: DM-VME03S) 4.4. Maintenance 4.4.1. Cleaning Plan ITEM Method Contamination and damage inspection of the Check appearance. Cleaning Period Check before use. Refer to Section 4.4.2 âCleaning & Storageâ 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. SMD-IFUE-DMV-001 Rev 0 40 Dr.MUSIC 3s (Model: DM-VME03S) 4.4.3. Replacing the Battery ďľ If the shelf life of battery is end, contact us and purchase the battery part. ďľ It p ro v id e s t h e ot h e r in fo rm at io n s uc h as c irc uit d ia g ra m s, par t s a nd de s cr i pt ion t h at is ne e d ed to re pa i r t he prod uc t w h en t he s er v i c e pe r so nn e l are re qu i re d. Te l : +8 2-7 0-7 525 -210 4 E - Ma i l: sa l es @ sm d2 1. com Ho m epa g e: ht t p : // w w w.s md 21. co m WARNING ďŹ Only the trained service personnel of the manufacturer will carry out the repair service. ďŹ 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 manufacturerâs warranty. ďŹ 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. SMD-IFUE-DMV-001 Rev 0 41 Dr.MUSIC 3s (Model: DM-VME03S) 4.5. EMC(Electro-Magnetic Compatibility) Gu id an c e an d Man u f a c tu r er âs D e c la r a t i on - E l ec tr om ag n e t i c E m is s i o n s â Th is d e vi c e i s i n ten d ed f o r u se i n th e e l ec tr om ag n et i c en v ir on m en t s p ec i f i ed b el o w. Th e u s er of th i s d e v i c e sh ou ld m a ke s u re i t i s u s ed in s u ch an en v ir on m en t . Emissions Test Compliance Electromagnetic Environment- Guidance Group 1 The device uses RF energy only for its internal function. Therefore, its RF emissions are very low RF emissions CISPR 11 and are not likely to cause any interference in nearby electronic equipment. RF emissions Class B CISPR 11 Harmonic emissions Class A IEC 61000-3-2 Voltage fluctuations/Flicker Complies emissions The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network. IEC 61000-3-3 Guidance and Manufacturerâs Declaration - Electromagnetic Immunity â 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 Floors should be wood, Electrostatic discharge (ESD) IEC 61000-4-2 concrete or ceramic tile. If Âą 6 kV contact Âą 6 kV contact floors are covered with Âą 8 kV air Âą 8 kV air synthetic material, the relative humidity should be at least 30 %. Âą 2 kV for power Âą 2 kV for supply Electrical fast supply lines mains Mains power quality should transient/burst Âą 1 kV for Âą 1 kV for be that of hospital IEC 61000-4-4 input/output input/output environment. lines lines Surge IEC 61000-4-5 Âą1 kV differential mode Âą2 kV common mode Âą1 kV differential mode Âą2 kV for common mode Mains power quality should be that of hospital environment. Voltage dips, <5 % UT <5 % UT Mains power quality should short (>95 % dip in UT) (>95 % dip in UT) be that of hospital SMD-IFUE-DMV-001 Rev 0 42 Dr.MUSIC 3s (Model: DM-VME03S) interruptions for 0.5 cycle for 0.5 cycle environment. If the user of and 40 % UT 40 % UT the device requires voltage (60 % dip in UT) (60 % dip in UT) continued operation during variations for 5 cycles for 5 cycles power mains interruptions, on power supply 70 % UT 70 % UT it is recommended that the input lines (30 % dip in UT) (30 % dip in UT) device be powered from an IEC 61000-4-11 for 25 cycles for 25 cycles uninterruptible power <5 % UT <5 % UT supply or a battery. (>95 % dip in UT) for 5 (>95 % dip in UT) for 5 s Power frequency magnetic Power frequency (50/60 Hz) magnetic field fields should be at levels 3 A/m 3 A/m characteristic of a typical location in hospital IEC 61000-4-8 environment. NOTE: UT is the ac. mains voltage prior to application of the test level. Guidance and Manufacturerâs Declaration - Electromagnetic Immunity â 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 IEC 60601 TEST Compliance test LEVEL level Electromagnetic environment â guidance Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended distance calculated applicable to from the separation the equation frequency of the transmitter. Conducted RF 3 Vrms IEC 61000-4-6 150 kHz to 80 MHz 3 Vrms Radiated RF 3 V/m 3 V/m IEC 61000-4-3 80 MHz to 2.5 GHz Recommended separation distance d = 1.2 âđ d = 1.2 âđ80MHz to 800 MHz d = 2.3 âđ800MHz 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 SMD-IFUE-DMV-001 Rev 0 43 Dr.MUSIC 3s (Model: DM-VME03S) 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. 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. 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 Separation distance according to frequency of transmitter, M output power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz transmitter, W d = 1.2 âđ d = 1.2 âđ d = 2.3 âđ 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 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. SMD-IFUE-DMV-001 Rev 0 44 Dr.MUSIC 3s (Model: DM-VME03S) 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 FCCâs 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. SMD-IFUE-DMV-001 Rev 0 45 Dr.MUSIC 3s (Model: DM-VME03S) 4.7. Marking plate ďŹ Trademark: Dr.MUSIC 3s ďŹ 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 SMD-IFUE-DMV-001 Rev 0 46
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