BEWELL CONNECT BW-TSX Mytens User Manual SMS lT5009 MDDX 161019

BEWELL CONNECT CORP Mytens SMS lT5009 MDDX 161019

Users Manual

BewellConnect - BW-TSX - User Manual - 072015 BewellConnect - BW-TSX - User Manual - 0720151 1BW-TSX0197 Manufacture：Nexmed Technology Co., LTD.Address：2nd Floor of No.1 building, Jia An Technological Industrial Park 67 District, Bao An 518101 Shenzhen - China BW-TSXWeb site: bewell-connect.com All Rights Reserved.Rev.V1.0 © 2015, 20150805
12This device complies with all the applicable standards and regulations related to expo- The device complies with all the standards relating to Class ll electrical medical devices and to devices which use electrical stimulation for use at home.Electromagnetic compatibility (EMC) : The device complies with safety standards EMC ISO 60601-1-2. It is designed to be used at home . without prior notice.Dear customer, Thank you for buying the Mytens device. We hope you get the best use out of it, and we recommend that you read these instructions carefully so that you can use it as device, please follow the treatment instructions in this user manual when using the device.1. WARNINGS- Please read this manual carefully and always follow the treatment instructions.- Only use this device for its intended purpose as described in these instructions.- This device may be used for personal use at home.- Use this device in an ambient temperature range of 5 to 40°C.- Do not expose this device to extreme temperature conditions > 50°C or < -10°C.- Do not use this device at a relative humidity of over 93%.- This device must always be placed in a clean and dry place.- Do not expose this device to lint,dust, sunlight or water.- Do not expose this device to electric shocks.- Never drop the device.- Do not attempt to open the device. In case of problems, contact your dealer.- This is a medical device. Keep out of the reach of children to avoid inhalation or swallowing of small parts.. - Discontinue use of the device in case of anomalies or malfunction.- Electronic medical equipment requires special precautions regarding electromechanical com-patibility. It must be installed and used in accord with EMC (ElectroMagnetic Compatibility) information.- This device must not be used in an environment of strong electromagnetic interference: Near a TV, a microwave oven or a mobile phone in use, etc.- This device is not designed to be used by persons (including children) whose physical, sensory or mental capabilities are reduced, or persons without experience or knowledge, unless they surveillance or prior instructions concerning use of the device. It is possible that they will not be able to use it in accordance with the instructions of this user manual and be disturbed by the treatment.- This product is not designed for use on children.- Do not modify the device or the electrodes without authorization of the manufacturer. This could cause a malfunction.- This device is designed for use by a single person and one person only.- Do not maintain or service the device while the device is in use. CONTENTS1. WARNINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... 12. TRANSCUTANEOUS NEUROSTIMULATION INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . 43. CHARACTERISTICS . . . . . . . . . ..................................................... 54. USE ............................................................................ 54.1 DESCRIPTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54.2. PRECAUTIONS BEFORE USE .................................................... 74.3 PRESENTATION OF THE PROGRAMMES . . . . . . . . . . . . ............................. 74.3.1. FORMS OF WAVES . . . . . . . . ................................................... 74.3.2. TENS PROGRAMMES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ............. 9 .................... .................... .....114.4. INDICATIONS BEFORE USE . . . . . . . . . . . . . . . . . . . . . . . . . . ..........................144.5. DOWNLOADING THE APPLICATION . . . . . . . . . . . . . . . . . ...........................154.6. STARTING AND USING . . . . . . . . . . . ..................................... ........ 165. STORAGE AND MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . ........................195.1. STORAGE OF THE ELECTRODES . . . . . . . . . . . . . . . . . . . . . . . . . . ......................195.2. CLEANING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..................196. TROUBLESHOOTING GUIDE . . . . . . . . .............................................207. AVOIDING MALFUNCTIONS . . . . . . . . .............................................208. TECHNICAL CHARACTERISTICS . . . . . . . . . . . . . . . . . . . . . . . . . . ........................219. PLACING THE ELECTRODES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .........22 ...................................................... .... 2611. DISPOSAL . . . . . ................................................. .............. 26............. ..............2913. WARRANTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... ..............3012. PLACING THE ELECTRODES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .............. 272712 10. SAFETY PRECAUTIONS
34-Pads should not touch each other when placed onto your skin.-The materials (e.g. ABS) of expect contact with patient had passed the ISO 10993-5 and ISO 10993-10 standards test, no toxicity, allergy and irritation reaction. However, based on the current science and technology, other potential allergic reactions are unknown.If you have allergic reaction to materials, please stop treatment immediately and consult your physician.-Keep the device out of the reach of children and pets to avoid inhalation or swallowing of small parts. Do not allow children to take their temperatures unattended. Children may not be able to use the device according to the instructions in this user manual. It is not a toy.-TENS is not eective for pain of central origin, including headache;-TENS is not a substitute for pain medications and other pain management therapies;-TENS devices have no curative value;-TENS is a symptomatic treatment and, as such, suppresses the sensation of pain that would otherwise serve as a protective mechanism;-Eectiveness is highly dependent upon patient selection by a practitioner qualied in the management of pain patients;-Use this device only with the self-adhesive hydrogel electrodes,the adapter and USB cord supplied with the device,which proved by manufacturer.-This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.Do not treat the the following parts or areas :- D-If you are in the care of a physician, consult with your physician before using this device;-If you have had medical or physical treatment for your pain, consult with your physician before using this device;-If your pain does not improve, becomes more than mild, or continues for more than ve days, stop using the device and consult with your physician;-The long-term eects of electrical stimulation are unknown;o not apply stimulation on your torso. Indeed, the introduction of electric current on this area can cause heart rhythm disturbances, with a risk of death.- be avoided.- on your blood pressure or your heart rhythm.- Do not position the electrodes on broken or injured skin, or which is dirty or unhealthy. Skin with irritation, sores or other lesions can lead to the injection of too much current on the area, which can cause burns.- Do not place the electrodes near cancerous lesions because this may have a negative impact on these injuries.- Do not place the electrodes on skin areas whose sensations are not normal. You may burn yourself due to a lack of feeling of the high intensity of the current.- (eg. phlebitis, thrombophlebitis and varicose veins). Stimulation should not be performed on areas of thrombosis or thrombophlebitis because it can promote the circulation and lead to a greater risk of embolism.- Do not put the electrodes on redness or open wounds. Open wounds may lead to applying too much current on the zone, causing burns. They can also favour the penetration of substances from the electrode into the skin.- Do not place the electrodes on the inside of body cavities, such as in the mouth. Indeed, this device is only designed for external application. - - - Do not make sudden movements during a session. This could cause a dysfunction of the device.Do not place the electrodes directly on the eyes,chest and the upper back or crossing over the heart.Do not use the device in the following conditions :- Do not use the device if you are connected to high frequency surgical equipment. This could lead to burns on the skin under the electrodes and damage the device.- Do not use the electro-stimulator if you are monitored by a doctor and you have not consulted him before using it.- In the case of internal bleeding due to impacts or injury, do not use the device. - To contract a muscle, do not use the electrical muscle stimulation in case of risk of muscle contraction that can disrupt the healing process. If the tendon or the muscle is torn, a muscle contraction can aggravate the wear, like a voluntary contraction. After recent surgery, after an acute trauma or fracture, this situation can also happen. In case of occurrence of a tendonitis, a muscle contraction can also aggravate the symptoms.- Do not use the device while driving, operating the machines or any other activity during which the electrical stimulation may lead to a risk of injury.- Do not use the appliance if you are subject to falling asleep during the session, as this may cause you to feel pain too late. If using at the time of goign to bed, set the timer so that the - Never use the device in contac t with water (in the bathroom, in the shower or in the pool, etc. ) because this increases the risk of an electric shock and skin burns.-Do not apply stimulation over your neck because this could cause severe muscle spasms resulting in closure of your airway, diculty in breathing, or adverse eects on heart rhythm or blood pressure;-Do not apply stimulation over, or in proximity to, cancerous lesions;
562. TRANSCUTANEOUS NEUROSTIMULATION INFORMATIONThe device works on the principle of transcutaneous electrical neurostimulation (TENS), which enables you to relieve pain and soothe muscle tension. This device also helps to promote venous return and to strengthen the muscle mass. The device has been specially designed to be used at home. Transcutaneous electrical neurostimulation (TENS) is a non-analgesic drug therapy the nerves. This stimulation brings the body to produce and disseminate endogenous analgesic-painkilling substances (endorphins, enkephaline) whose function is to anesthetize the pain.In case of pain or muscle tension, mini-electrical impulses in the nervous tissue may block the transmission of pain signals to the nervous system and trigger the release of endorphins. You can choose your programme among 11 preset TENS protocols on theapplication. For the strengthening of your muscle mass, you can select a programme among 8 protocols of electrical muscle stimulation (EMS). The electrical stimulator sends, via the electrodes placed zones helps you to position the electrodes correctly (see paragraph 10).The application (Mytens) is available on the App Store or Google play. The app operates on IOS, Android platforms (IOS 8.0, Android 5.0).Intended useThe device designed to be used for temporary relief of pain associated with sore and 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. It should be applied to normal, healthy, dry and clean skin of adult patients. And is to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.ContraindicationDo not use this device with the following medical devices:-Implanted electronic medical devices, such as pacemakers. This may cause electric shock, burns, or death.-Electronic life support equipment, such as respirators.-Electronic medical devices worn on the body, such as electrocardiographs.If you use this device together with other electronic medical devices, these devices may not work correctly.on the area to stimulate, electrical pulses causing a muscle contraction which strengthens the muscle. It is controlled from the application. A diagram of the human body with treatment to avoid triggering of contractions. Always consult your doctor or midwife if you are pregnant and intend to use the device.- cal muscle stimulation (EMS) device could in this case cause a blood clot. - In case of cognitive impairment- - If your pains have not been diagnosed, with the exception of the positive opinion of your doc-tor to use this device-if stimulation is applied over the menstruating or pregnant uterus; -if stimulation is applied over areas of skin that lack normal sensationFCCCaution: The user is cautioned that changes or modications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.NOTE: 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 o 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 dierent from that to which the receiver is connected. -- Consult the dealer or an experienced radio/TV technician for help.FCC Radiation Exposure Statement:This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or operating in conjunction with any other antenna ortransmitter..Counter indicationsDo not use the device :- In case of heart disease- If you have epilepsy- example a drug administration system). In these conditions, use could cause an electric shock, interference, burns or even death. - -tus are not yet known. During pregnancy, do not use the appliance on the uterus or abdomen
587- During the EMS session or shortly after, redness of the skin may occur at the level of the elec-trodes (around or below). They usually disappear within two hours of the session. In case of persistence of the redness for more than 24h, please consult your doctor. - An electrical muscle stimulation (EMS) session can cause muscle pain for some time. Reactions-fects may occur in the form of :- Nausea or fainting- Burns at the location of the electrodes- Painful sensations, headache- Irritation of the skin in the place of the electrodes, even if the gel present on the electrodes does not present any known risk of allergic reactions to this day.3. CHARACTERISTICS- Pain relief and healing of muscle tension (TENS : 11 preset programmes)- Strengthening of the muscular mass (EMS : 8 standard programmes)- Stimulation of the venous return (TENS)- Easy to use- Data transfer onto a phone or a Bluetooth 4.0 tablet 4. USE4.1 DESee schema in page 8SCRIPTIONSee schema A page 6 2 Status indicat 4 Micro-USB socket of the device 5 Electrodes-You should stop using the device and should consult with your physician if you experience adverse reactions from the deviceThe gift box contains the follwing conponents:Standard Parts:NO. Description Quantity1 BW_TSX 1PCS2 Electrode pad(50*56mm) 2pcs3 Adaptor 1PCS4 Micro-USB cable 1PCS5 Instruction manual 1PCS1 2 Status indicator3 Removable connector 4 Micro-USB socket of the device 5 8 EleBattery indicator 9 Socket for standard USB plugctrodes 6 Micro-USB cable7 10 AdaptorStandard USB plug11 12 Micro-USB plug Detachable connectorABYear Month DaySerial numberSNSN:Serial number132412678109511
9 104.2. PRECAUTIONS BEFORE USE- Use the transcutaneous electrical neurostimulation programmes in bursts (TENS Burst) at rest. Indeed, they can cause a muscle contraction in the treatment area.- In case of recent surgery, consult a doctor before using the device. The use of this device may - It is necessary to complete the treatment in the of the device before removing the electrodes. If you do not complete the treatment and remove the electrodes or the device, and if you touch the connectors, it is possible to feel pain - Before any use of electrodes, check their expiration date on the packaging. If the date has expired, do not use them. - Use new electrodes when the electrodes are damaged, dirty, less adhesive or if you begin to feel discomfort during stimulation (uncomfortable pinching, tingling).- This product must only be used with the adapter, the cable and accessories recommended by the manufacturer.- Before use, check that the device and the electrodes are not damaged. In case of any damage, do not use the device or one of the electrodes.- Usable indoors and outdoors, the device is not designed to withstand all weather conditions.- The device is not waterproof. Do not wet it and never use it in a damp environment.- Do not use plaster or tape to attach the electrodes to the skin.- For storing the electrodes, please follow the instructions in section 6.1 “Storage of electrodes”.- - - - In case of abnormal operation of the device in accordance with this user manual, discontinue use and contact the after-sales department. Consult section 7 “Troubleshooting Guide” for information concerning potential malfunctions of the device. The patients can operate the equipment by themselves. The patient can safely use the all the functions of the device. They can charge the device, cleaning the device and accessories bythemselves.The patient should contact the MANUFACTURER or the MANUFACTURER'S representative:For assistance, if needed, in setting up, using or maintaining the ME EQUIPMENT or ME SYSTEM; orTo report unexpected operation or events.4.3 PRESENTATION OF THE PROGRAMMES4.3.1. FORMS OF WAVESCONT : Form of continuous wave HANS : Form of alternating wave gBURST : Wave form deviation
1112-EMS : wave form 4.3.2. TENS PROGRAMMESTraditional transcutaneous neurostimulation programme : A common transcutaneous neurostimulation programme is performed with a high frequency stimulation. This stimulation is intended to block the transmission of the pain signal to the nervous system. Generally, people use traditional transcutaneous neurostimulation for a session of about 30 minutes. It is possible to use these programmes for a variable period and frequency according to -adjust the intensity of the programme, avoiding any painful or unpleasant sensation. Burst transcutaneous neurostimulation programme : A burst programme (Burst TENS) allows high frequency stimulation in the form of series of impulses. It enables the release of endorphins. It is possible to use the transcutaneous neuro-stimulation in bursts for 30 minutes. The frequency can be up to several times per day, 3 times for example. For a sensation of strong stimulation, it is advisable to adjust the intensity of the burst programme. An unpleasant feeling may then appear. You can also adjust the intensity of the programme at a level leading to perceptible muscle contractions in the stimulation area. These contractions are not dangerous. However, if you experience discomfort, it is advisable to decrease the intensity of the programme, change or move the electrodes. The burst transcuta-neous electrical neurostimulation (Burst TENS) can trigger a muscle contraction in the area of stimulation. We therefore ask you to perform this programme at rest. Summary Table of the TENS ProgrammesTENS ImpulsesTreatment siteNameTreatment timeTreatment phasesFrequency (time)Width in μS Wave formDescriptionShoulderShoulder pain and wrinkled shoulder froissée30minPhase 12Hz (10s)250CONTContinuous outputPhase 24Hz (8s)250Phase 36Hz (6s)250Lumbar areasPain in the lower back30minPhase 180Hz (20s)250CONTContinuous outputPhase 280Hz (20s)250Phase 375Hz (4s)250Phase 410Hz (20s)250Phase 570Hz (4s)250Phase 665Hz (4s)250Elbow Pain in the elbow 30min Phase 12Hz (3s)200 HANSAlternating outputPhase 2100Hz (3s)150ForearmPain in the forearm30minPhase 12Hz (3s)200 HANSAlternating outputPhase 2100Hz (3s)150 HANSWristPain in the wrist and carpal tunnel syndrome30min Phase 12Hz250 CONTContinuous outputHipPain in the hip30minPhase 16Hz (30s)250CONTContinuous outputPhase 26Hz (30s)250Phase 38Hz (20s)250Phase 48Hz (20s)250Phase 510Hz (20s)250Phase 610Hz (20s)250Thigh Sciatic pain 30min Phase 1100Hz200 EMSUp : 0,5sCon : 7sDown : 0,5sRest : 7sKnee Knee pain 30min Phase 1100Hz150 BURSTOn : 0,25s
13 14Lower leg Pain in the lower leg 30min Phase 1100Hz150 BURSTOn : 0,25sAnklePain in the ankle and Achilles tendon problem30min Phase 1100Hz200 CONTContinuous outputFootPain in the foot30minPhase 140Hz (5s)250CONTContinuous outputPhase 26Hz (10s)250Phase 350Hz (5s)250These programmes, commonly called “neuromuscular electrical stimulation” (NMES) or “elec-tromyostimulation”, emit impulses to cause a muscle contraction. They are especially used for strengthening the muscle mass. Only perform the electrical muscle stimulation programme on intact and healthy muscles. Because they involve muscle contraction, they need to be per-formed at rest (lying or sitting). -sation. It is advisable to begin the programme on low intensity and change to a higher one to become used to it. The stimulation must remain comfortable and muscle contractions must not are advised to choose a low intensity to limit muscular fatigue. Summary Table of the EMS ProgrammesEMS ImpulsesTreatment siteNameTreatment timeTreatment phasesFrequency (time)Width in μSWave formDescriptionShoulderResistance of the trapezoid28minPhase 15Hz (5min)280EMSPreparation phasePhase 255Hz (10s)280Intensity : 50%Up : 1,5sDown : 0,75sPhase 36Hz (8s)280Intensity: 25%Phase 43Hz (10min)280Phase of relaxationIntensity : 40%Abdo-minalResistance of ab-dominal muscles22mnPhase 130Hz (2min)200EMSUp : 10sCon : 5sDown : 10sRest : 5sPhase 245Hz (9min)200Up : 5sCon : 5sDown : 5sRest : 5sPhase 360Hz (9min)200Up : 6sCon : 8sDown : 6sRest : 5sPhase 430Hz (2min)200Up : 10sCon : 5sDown : 10sRest : 5sLumbar areasResis-tance of the lower back28mnPhase 15Hz (5min)300EMSPreparation phasePhase 255Hz (10s)300Intensity : 50%Up : 1,5sDown : 0,75sPhase 36Hz (8s)300Intensity: 25%Phase 43Hz (10min)300Phase of relaxationIntensity : 40%
15 16ForearmFront-arm : Extender of the wrist and Front-arm : Bender of the wrist and 28minPhase 15Hz (5min)300EMSPreparation phasePhase 255Hz (10s)200Intensity : 50%Up : 1,5sDown : 0,75sPhase 36Hz (8s)200Intensity: 25%Phase 43Hz (10min)200Phase of relaxationIntensity : 40%HipResistance of the hip muscle32minPhase 15Hz (5min)300EMSPreparation phasePhase 275Hz (6,3s)300Intensity : 50%Up : 1,5sDown : 0,75sPhase 34Hz (8s)300Intensity: 25%Phase 43Hz (10min)300Phase of relaxationIntensity : 40%ThighResistance of the hamstring muscle28mnPhase 15Hz (5min)370EMSPreparation phasePhase 255Hz (10s)370Intensity: 50% Up: 1.5s Down: 0.75sPhase 36Hz (8s)370Intensity: 25%Phase 43Hz (10min)370Phase of relaxation Intensity: 40%Lower legResistance of the calf muscles28minPhase 15Hz (5min)370EMSPreparation phasePhase 255Hz (10s)370Intensity: 50% Up: 1.5s Down: 0.75sPhase 36Hz (8s)370Intensity: 25%Phase 43Hz (10min)370Phase of relaxation Intensity: 40%FootTraining the foot30min Phase 150Hz200 EMSUp : 2sCon : 8sDown : 2sRest : 4s4.4. INDICATIONS BEFORE USECharging the deviceFirstly charge the device before use. In normal times (ambient temperature), it takes 5 hours to charge the device. A full charge allows a battery life of about 8 hours continuously when functioning in normal conditions. Please charge the device fully before beginning a session. If the charge is not complete at the beginning of a programme, the battery may become deplete before the end of the session. You cannot use the device when it is on charge.1. Disconnect the cable used to connect the two units of the micro-USB of the unit with the battery light .2. Insert the micro-USB cable into the micro-USB socket for the respective unit .3. Connect the Micro-USB cable to the adaptor, and then insert the adaptor to the SUPPLY MAINS.4. When the battery light goes into continuous orange (which means that the battery is be-ing charged) to a continuous green (the battery is full), remove the micro-USB plug from the micro-USB socket of the unit with the battery indicator (see diagram 4). Use the USB plug only for the use described above (to charge and connect to the cable connecting the two units).5. Reconnect the cable connecting the two units : Insert the connector of this cable into the micro-USB socket for the unit with the battery light .Caution:The life of a rechargeable battery depends on the number of recharging/rundown cycles it undergoes and how these cycles are performed. The service life of rechargeable battery is more than 300 recharging/rundown cycles.We provide the following suggestions for the longer life of the battery:1) Whenever the device is not used frequently, we recommend recharging the battery once a month.2) The device can only be used safely with the original recharger, DO NOT re-assemble or manufacturer or distributor.
17184.5. DOWNLOADING THE APPLICATIONDownload the application to your phone or tablet:- by the App store or Google PlayThen click the MyTens icon.4.6. STARTING AND USING Preparation of the treatment areas and installation of the stimulator1. Before placing the electrodes, check that the skin does not show injury or redness and is healthy.t Transcutaneous electrical neurostimulation (TENS) programmes : Do not position the elec-trodes on irritated skin or skin with open wounds, rashes or cancerous lesions t Electrical muscle stimulation (EMS) programmes : Position the electrodes only on intact and healthy muscles. 2. Using a damp cloth, clean the skin and then dry it. To receive the electrodes, it must be clean and dry, without cream or lotion. Any oil, dust or other element that may be on the skin could prevent the electrodes from adhering. 3. Remove the electrodes from the bag, ensure they are not damaged or worn. If the expiry limit is exceeded, do not use these electrodes.4. Pull the electrode o the liner, and attach the electrodes to the device using the pressure buttons provided for this purpose. 5. See the section"PLACING THE ELECTRODES".6. Put the second electrode on the area of the body to treat (See the section"PLACING THE ELECTRODES"). Avoid any contact between the electrodes and not place one on the otheNote:Replace the electrodes when they are damaged or dirty, when they have lost their adhesive power or when stimulation becomes uncomfortable, i.e. when you experience an unpleasant stinging or biting sensation.Note：Always connect the device before you place the electrodes on the skin.Note: Do not place the electrodes on top of each other or so close to each other that they touch each other.r. Remarks- under clothing.- You can keep a device on the body, even between two sessions.- It is possible that you may need external assistance for placing the electrodes in certain areas.Locating the electrodesWarning As indicated in “Do not treat the the following parts or areas” :Do not place the electrodes on the head, carotid, on any side of the neck, at the front of the neck or on the torso. Do not position the electrodes on swollen skin or skin with open wounds, rashes or cancerous lesions or on irritated skin. skin. You are advised to place the electrodes at the level of the area to be treated or in the vici-nity of this area. Before installing the electrodes in a place, ensure you have good feeling in the -rostimulation programmes), it is advisable to move the electrodes. If during electrical muscle stimulation programmes (intended especially to create a contraction of the muscle) no contrac-tion occurs, this may mean an intensity too low or bad installation of the electrodes.Starting a session through the use of the application 1. Ensure that the Bluetooth (4.0) connection is activated on your smartphone or tablet. Open the application . 2. 3 Standby mode, ready for the session). The App detects the stimulator which is switched on. t3. Open the BW-TSX device and your APP,and the indicator on your APP transform red to green in g. 3.1 below. And tap the button to known the information about "TENS" and "EMS", and then tap "OK" to continue, in g.3.2 below.o begin a session. In g.3.1 g.3.2
In the case of past use ofthe stimulator , you can start again the last session or choose another one in the history. History Button4. Choose between "Start Pain REliever (TENS) or Start Electro Stimulation (EMS)". At rst-time use, you always have to select a treatment area. If you have used the device before, you can choose between ‘RETRY’to repeat the previous treatment and ‘NEW SESSION’ to start a new treatment. 5. Tap on one of the suggested locations for the electrodes to select the area you want to treat. Select one of the two locations, if there have more than one locations. Rate the intensity of your pain on a scale from 0 to 10. Your pain is somewhere in between, rate it by tapping the appropriate number. Note: The pain intensity you indicate is not used by the app to determine the intensity of the treatment. The rating is only stored in your treatment diary.6. And after you rate your intensity of your pain, you can tap "START SESSION", and then you can select your intensity lever you want. Starting and stopping a treatment -Tap the play button on the screen. -The treatment screen opens and the time starts to count down. -The status indicator on the device starts to ash orange. -On the treatment screen, you can tap the + or the - to increase or decrease the intensity to a comfortable level. -If you increase the intensity lever to "10",there will show some information about "careful" on your screen, and then tap "Continue" to go on your treatment. -In programs with a specied maximum treatment time, treatment continues until the timer has counted down to 0. It continues to count up until you stop the treatment. If you want to stop or interrupt the treatment, tap the square in the center of the pulsing treatment indicator to stop the program. Also, you can resume your treatment. -After your treatment is over, you can evaluate this treatment according to your feel.19 20According to the history treatment,you will get these information as follows:Treatment type;Zone;Time;Number of Mytens;Pain lever;Intensity lever;Satisfaction;Duration; 7. Also, you can choose history treatment and settings. And also, you can tap the setting button. Srtting Button
21 222. 1. Remove the electrodes from the skin. Place the electrodes back on the liner. Detach from the edges.When you nished your treatment:3. Remove the device from the electrodes. If you forget the device for more than 3 minutes, it If the device is frequently used during the day, it is advisable to charge it before starting a new session.Caution: Always end the treatment in the app or by pressing the on/o button before you remove the device or the electrodes. If you fail to do this, you may get an unpleasant sensation in your ngers when you touch the connectors. This sensation is not harmful, but it can be unpleasant.Replacement ElectrodesReplace the electrodes if:-they are damaged or torn.-they are past the use-by date indicated on the resealable bag.-they have lost their adhesive power. Never use plaster or tape to attach them to your skin.-stimulation feels less strong.-when stimulation is uncomfortable, i.e. when you experience an unpleasant stinging or biting sensation.Note: Always replace the electrodes with electrodes recommended for this device by the manufacturer.5. STORAGE AND MAINTENANCE5.1. STORAGE OF THE ELECTRODESPut the electrodes back into their protective bag. To prevent buildup of dust on the electrodes, close the bag carefully. Prefer to store electrodes in a place where the temperatures is 5 to 27°C. Avoid extreme heat and exposure to direct sunlight. Do not keep the electrodes in the freezer or the refrigerator.5.2. CLEANINGWarning : Never immerse the product in water and do not rinse it. Never immerse the elecThis device may be used for personal use. You should clean the device and electrodes after use. trodes in water. Do not use cleaning agents other than those mentioned below. They could cause serious damage to the equipment.1. Using a damp cloth and mild detergent (eg: dishwashing liquid), clean the device. It is also possible to use isopropyl alcohol at 70° (IPA). 2. from the surface. Do not use soap or alcohol to clean the electrodes.
23 249. IMPORTANT INFORMATION REGARDING ELECTROMAGNETIC COMPATIBILITY (EMC)- The use of accessories, transducers and cables other than those mentioned or provided by With the increased number of electronic devices such as computers and mobile (cellular) telephones, medical devices in use may be susceptible to electromagnetic interference from other devices. Electromagnetic interference may result in incorrect operation of the medical device and create a potentially unsafe situation. Medical devices shouldalso not interfere with other devices.In order to regulate the requirements for EMC (Electromagnetic Compatibility) with the aim to prevent unsafe product situations, the IEC60601-1-2 standard has been implemented. This levels of electromagnetic emissions for medical devices.The stimulator conform to this IEC60601-1-2:2007 standard for both immunity and emissions.Nevertheless, special precautions need to be observed:- The use of accessories other than those provided by manufacturer , may result in increased emission or decreased immunity of the device.- Refer to EMC table guidance regarding the EMC environment in which the device should be used.the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and increase the risk of malfunction8. TECHNICAL CHARACTERISTICSUnits 2 Units (49.9mmx55.8mm)Programmes 19 programmes (11 TENS + 8 EMS programmes)Battery 3.7V/500mAh Li-lonOutput voltage max 60mA ±10% (1000Ω load)Conditions of use 5°C to 40°C with a relative humidity of 15% to 93%, atmospheric pressure of 700 to 1060 hPaStorage and Transportation Conditions -10°C to 55°C with a relative humidity of 10% to 90%, atmospheric pressure of 700 to 1060 hPaDimensions 440x54x13mm cable includedWeight 55g (±20%) by unitIP22Wave form Biphasic square wave (net current 0dc) Impulse width 150us~370us (±10%)Heart rhythm 2Hz~100Hz (±10%)Treatment time 22min/30min given by the applicationAdapter 1pc (Input : 100-240 V AC 50/60Hz Output : 5 V DC Service life of the device 2 years Service life of electrode pads Applied part Electrode sizeEelctrode impadence 10 timesEelctrode28*25mm(ellipse)≤500Ω300mA) Guidance and manufacturer’s declaration – electromagnetic emissionsThe customer or the user of these electrical stimulators should assure that it is used in such environment.Emissions test Compliance Electromagnetic environment - guidanceRF 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 and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Harmonic emissions lEC 61000-3-2 Class AVoltage fluctuations/ flicker emissions lEC 61000-3-3CompliesTABLE 1:
25 26Guidance and manufacturer’s declaration – electromagnetic IMMUNITYThe customer or the user of these electrical stimulators should assure that it is used in such environment.Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidanceElectrostatic discharge (ESD) lEC 61000-4-2±6 kV contact ±8 kV air±6 kV contact ±8 kV airFloors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, therelative 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±2kV for power supply linesMains power quality should be that of a typical commercial or hospital environment. SurgeIEC 61000-4-5± 1 kV line(s) to line(s)± 2 kV line(s) to earth±1 kV dierential modeMains power quality should be that of a typical commercial or hospital environment.Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11<5% UT (>95% dip in UT)for 0.5 cycle40% UT(60% dip in UT)for 5 cycles70% UT(30% dip in UT)for 25 cycles<5% UT (>95% dip in UT)for 5 sec<5% UT (>95% dip in UT)for 0.5 cycle40% UT(60% dip in UT)for 5 cycles70% UT(30% dip in UT)for 25 cycles<5% UT (>95% dip in UT)for 5 secMains power quality should be that of a typical commercial or hospital 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(50/60Hz) magnetic fieldIEC 61000-4-83 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. TABLE 2: Guidance and manufacturer’s declaration – electromagnetic IMMUNITYThe customer or the user of these electrical stimulators should assure that it is used in such environment.Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance Conducted RFlEC 61000-4-63 Vrms150 kHz to 80 MHz Radiated RFlEC 61000-4-33 V/m80 MHz to 2.5 GHz 3 V/m3 VrmsPortable and mobile RFCommunications equipment should be used no closer to anypart of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.Recommended separation distanced = 1.2d = 1.2 80 MHz to 800 MHzd = 2.3 800 MHz to 2.5 GHzWhere P is the maximum output power rating of the transmitter in watts (W) according to the. Transmitter manufacturer and dis the recommended separation distance in meters (m).Ftransmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.bInterference may occur in the vicinity of equipment marked with the following symbol: TABLE 4: NOTE I At 80 MHz ends 800 MHz the higher frequency range applies.NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is 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, should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. b
27 28 10. SAFETY PRECAUTIONS 11. DISPOSALIP 22 CThe rst number 2: Protected against solid foreign objects of 12,5 mm Ф and greater. The second number: Protected against vertically falling water drops when enclosure titled up to 15º. Vertically falling drops shall have no harmful eects when the enclosure is titled at any angle up to 15º， on either side of the vertical.autionGarder au sec / Keep dry Refer to instruction manual. Note on the equipment “Follow instructions for use”. Type BF applied part such as electrode The device, accessories and the packaging have to be disposed correctly at the end of the us-age. Please follow local ordinances or regulations for disposal. ManufacturerSN Serial numberThis symbol means that this device emits nonionising radiation. All devices and systems that include RF transmitters or that intentionally apply RF electromagnetic energy must be labelled withthis symbol.Obsolete batteries must be disposed of in a specially labeled collection container, at toxic waste collection points or through an electrical retailer.You are under legal obligation to dispose of batteries correctly.Please dispose of the device in accordance with the legal obligation.For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters (m) canbe 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 I 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 Note: EMC tests conducted including attached electrode cord of 1.5 m length. The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitterWSeparation distance according to frequency of transmitterm150 kHz to 80 MHz d = 1.2 80 MHz to 800 MHz d = 1.2 800 MHz to 2.5 GHz d = 2.3 0.01 0.12 0.12 0.230.1 0.38 0.38 0.731 1.2 1.2 2.310 3.8 3.8 7.3100 12 12 23TABLE 6: Recommended separation distances betweenportable and mobile RF communications equipment and the device
29 3012. PLACING THE ELECTRODESShoul-derShoulder pain and wrinkled shoulder Lumbar areasPain in the lower back Elbow Pain in the elbow Fore-armPain in the forearm WristPain in the wrist and carpal tunnel syndrome Hip Pain in the hip 12Thigh Sciatic pain Knee Knee pain Lower legPain in the lower leg AnklePain in the ankle and Achilles tendon problem Foot Pain in the foot
3213. WARRANTYLower legResistance of the calf muscles Foot Training the foot Shoul-derResistance of the trapezoid Abdo-minalResis-tance of abdominal muscles Lumbar areasResis-tance of the lower back Fore-armExtender of the wrist and Bender of the wrist and HipResistance of the hip muscle ThighResistance of the hamstring muscle Bewell Connect Corp.Bewell Connect Corp.Bewell Connect CorpBewell Connect -Corp.Bewell Connect Corp. will repair or replace this product free of charge in the case of defective parts faor manu- cturing defects, in accordance with the conditions mentioned below as follows:DURATION: 24 MONTHS RETURN TO WORKSHOP-voice, or another proof of purchase, with this guarantee card will be required to obtain an after-sales service, in accordance with this guarantee. This guarantee card will not be extended to another per--including the user.This guarantee covers only the defects of the material or parts, occurring during normal use of the pro-duct. It does not cover the damage caused during the transport of the apparatus, causes due equipment not approved by or causes con tr ary to those written in the user manual or notice. Moreover, the present guarantee does not cover damage due to falls, bad handling, bad in-cover the packing of the material, the accessories, the defects caused by commercial exposure of the product, show room, sale space, demonstration etc... Normal maintenance, cleaning and the replace-ment of parts where wear is normal, are not covered by the terms of this guarantee. and its representatives and agents will not in any case be held responsible for any damage and consecutive damages due to the mishandling of this product. This guarantee is the only valid one at , any other guarantee (commercial guarantee) except this one will not be takennto account.contact the customer service.31

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