BEWELL CONNECT BW-TSX Mytens User Manual SMS lT5009 MDDX 161019
BEWELL CONNECT CORP Mytens SMS lT5009 MDDX 161019
Users Manual
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| Document ID | 3209406 |
| Application ID | NvTOzDXxoug3nPuFbrXJcA== |
| Document Description | Users Manual |
| Short Term Confidential | No |
| Permanent Confidential | No |
| Supercede | No |
| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 101.09kB (1263585 bits) |
| Date Submitted | 2016-11-28 00:00:00 |
| Date Available | 2016-11-28 00:00:00 |
| Creation Date | 2016-11-14 10:57:48 |
| Producing Software | Acrobat Distiller 11.0 (Windows) |
| Document Lastmod | 2016-11-14 10:57:48 |
| Document Title | SMS-lT5009-MDDX-161019 |
| Document Creator | Adobe Illustrator CS5 |
| Document Author: | Rita_Zhao |
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-TSX Web site: bewell-connect.com All Rights Reserved.Rev.V1.0 © 2015, 20150805 BewellConnect - BW-TSX - User Manual - 072015 0197 BW-TSX BewellConnect - BW-TSX - User Manual - 072015 This device complies with all the applicable standards and regulations related to expoThe 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 . CONTENTS 1. WARNINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2. TRANSCUTANEOUS NEUROSTIMULATION INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . 4 3. CHARACTERISTICS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 4. USE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 4.1 DESCRIPTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 4.2. PRECAUTIONS BEFORE USE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 4.3 PRESENTATION OF THE PROGRAMMES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 4.3.1. FORMS OF WAVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 4.3.2. TENS PROGRAMMES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 . . . . . . . . . . . . . . . . . . . . 11 4.4. INDICATIONS BEFORE USE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 4.5. DOWNLOADING THE APPLICATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 4.6. STARTING AND USING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 5. STORAGE AND MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 5.1. STORAGE OF THE ELECTRODES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 5.2. CLEANING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 6. TROUBLESHOOTING GUIDE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 7. AVOIDING MALFUNCTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 8. TECHNICAL CHARACTERISTICS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 9. PLACING THE ELECTRODES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 10. SAFETY PRECAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... 26 11. DISPOSAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 12. PLACING THE ELECTRODES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 12 . . . . . . . . . . . . . . . . . . . . . . . . . 27 . . . . . . . . . . . . . . . . . . . . . . . . . . .29 13. WARRANTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30 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 compatibility. 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. without prior notice. -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 effective 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; -Effectiveness is highly dependent upon patient selection by a practitioner qualified 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 : -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 five days, stop using the device and consult with your physician; -The long-term effects of electrical stimulation are unknown; - Do 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 apply stimulation over your neck because this could cause severe muscle spasms resulting in closure of your airway, difficulty in breathing, or adverse effects on heart rhythm or blood pressure; -Do not apply stimulation over, or in proximity to, cancerous lesions; - 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 contact 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. 2. TRANSCUTANEOUS NEUROSTIMULATION INFORMATION The 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 analgesicpainkilling 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 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 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 use The 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. Contraindication Do 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. 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 doctor 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 sensation FCC Caution: The user is cautioned that changes or modifications 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 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 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 or transmitter. Counter indications Do 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 See schema A page 6 - During the EMS session or shortly after, redness of the skin may occur at the level of the electrodes (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. -You should stop using the device and should consult with your physician if you experience adverse reactions from the device Status indicat Micro-USB socket of the device Electrodes 10 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 11 4. USE 4.1 DESCRIPTION The gift box contains the follwing conponents: Standard Parts: NO. Description Quantity 1 BW_TSX 1PCS 2 Electrode pad(50*56mm) 2pcs 3 Adaptor 1PCS 4 Micro-USB cable 1PCS 5 Instruction manual 1PCS See schema in page 8 12 Status indicator Removable connector Micro-USB socket of the device 7 Adaptor Electrodes Micro-USB cable Battery indicator Socket for standard USB plug SN Serial number SN: 10 Standard USB plug 11 Micro-USB plug 12 Detachable connector Year Month Day Serial number 4.2. 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 HANS : Form of alternatingg wave - 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 in formation 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 by themselves. 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; or - To report unexpected operation or events. BURST : Wave form deviation 4.3 PRESENTATION OF THE PROGRAMMES 4.3.1. FORMS OF WAVES CONT : Form of continuous wave 10 EMS : wave form Summary Table of the TENS Programmes TENS Name Treatment time Shoulder Shoulder pain and wrinkled shoulder froissée 30min Lumbar areas 4.3.2. TENS PROGRAMMES Traditional 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 neurostimulation 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 transcutaneous electrical neurostimulation (Burst TENS) can trigger a muscle contraction in the area of stimulation. We therefore ask you to perform this programme at rest. 11 Impulses Treatment site Elbow Forearm Wrist Hip Pain in the lower back Pain in the elbow Pain in the forearm Pain in the wrist and carpal tunnel syndrome Pain in the hip Treatment phases Frequency (time) Width in μS Phase 1 2Hz (10s) 250 Phase 2 4Hz (8s) 250 6Hz (6s) 250 Phase 1 80Hz (20s) 250 Phase 2 80Hz (20s) 250 Phase 3 75Hz (4s) 250 Phase 4 10Hz (20s) 250 Phase 5 70Hz (4s) 250 Phase 6 65Hz (4s) 250 Phase 1 2Hz (3s) 200 Phase 2 100Hz (3s) 150 Phase 1 2Hz (3s) 200 HANS Phase 2 100Hz (3s) 150 HANS Phase 1 2Hz 250 CONT Continuous output Phase 1 6Hz (30s) 250 Phase 2 6Hz (30s) 250 Phase 3 8Hz (20s) 250 Phase 4 8Hz (20s) 250 CONT Continuous output Phase 5 10Hz (20s) 250 Phase 6 10Hz (20s) 250 Up : 0,5s Con : 7s Down : 0,5s Rest : 7s Phase 3 30min 30min Wave form Description CONT Continuous output - CONT Continuous output HANS Alternating output Alternating output 30min 30min 30min Thigh Sciatic pain 30min Phase 1 100Hz 200 EMS Knee Knee pain 30min Phase 1 100Hz 150 BURST On : 0,25s 12 Lower leg Ankle Foot Pain in the lower leg 30min Pain in the ankle and Achilles tendon problem 30min Pain in the foot 30min Phase 1 Phase 1 100Hz 100Hz 150 200 Phase 1 40Hz (5s) 250 Phase 2 6Hz (10s) 250 Phase 3 50Hz (5s) 250 BURST CONT CONT On : 0,25s Continuous output Abdominal Resistance of abdominal muscles Lumbar areas Summary Table of the EMS Programmes Name Impulses Treatment time Treatment phases Phase 1 Phase 2 Shoulder Resistance of the trapezoid Width in μS Wave form 280 55Hz (10s) 280 Intensity : 50% Up : 1,5s Down : 0,75s 6Hz (8s) 280 3Hz (10min) 280 5Hz (5min) EMS Phase 4 Up : 10s Con : 5s Down : 10s Rest : 5s Phase 2 45Hz (9min) 200 Up : 5s Con : 5s Down : 5s Rest : 5s Resistance of the lower back EMS Phase 3 60Hz (9min) 200 Up : 6s Con : 8s Down : 6s Rest : 5s Phase 4 30Hz (2min) 200 Up : 10s Con : 5s Down : 10s Rest : 5s Phase 1 5Hz (5min) 300 Preparation phase Intensity : 50% Up : 1,5s Down : 0,75s Phase 2 55Hz (10s) 300 Phase 3 6Hz (8s) 300 Intensity: 25% Phase 4 3Hz (10min) 300 Phase of relaxation Intensity : 40% 28mn EMS Description Preparation phase 28min Phase 3 13 Frequency (time) 200 22mn are advised to choose a low intensity to limit muscular fatigue. Treatment site 30Hz (2min) Continuous output These programmes, commonly called “neuromuscular electrical stimulation” (NMES) or “electromyostimulation”, 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 performed 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 EMS Phase 1 Intensity: 25% Phase of relaxation Intensity : 40% 14 Frontarm : Extender of the wrist and Forearm Frontarm : Bender of the wrist and Phase 1 Phase 2 Thigh Resistance of the hamstring muscle Preparation phase 200 Intensity : 50% Up : 1,5s Down : 0,75s EMS Phase 3 Phase 1 Resistance of the hip muscle 55Hz (10s) 300 28min Phase 4 Hip 5Hz (5min) 6Hz (8s) 3Hz (10min) 5Hz (5min) 200 Intensity: 25% 200 Phase of relaxation Intensity : 40% 300 Preparation phase Intensity : 50% Up : 1,5s Down : 0,75s Phase 2 75Hz (6,3s) 300 Phase 3 4Hz (8s) 300 Intensity: 25% Phase 4 3Hz (10min) 300 Phase of relaxation Intensity : 40% 32min EMS Phase 1 5Hz (5min) 370 Preparation phase Phase 2 55Hz (10s) 370 Intensity: 50% Up: 1.5s Down: 0.75s Phase 3 6Hz (8s) 370 Intensity: 25% Phase 4 3Hz (10min) 370 Phase of relaxation Intensity: 40% EMS 28mn Lower leg Foot Resistance of the calf muscles Training the foot Phase 1 5Hz (5min) 370 Preparation phase Phase 2 55Hz (10s) 370 Intensity: 50% Up: 1.5s Down: 0.75s Phase 3 6Hz (8s) 370 Intensity: 25% Phase 4 3Hz (10min) 370 Phase of relaxation Intensity: 40% Phase 1 50Hz 200 EMS 28min 30min EMS Up : 2s Con : 8s Down : 2s Rest : 4s 4.4. INDICATIONS BEFORE USE Charging the device Firstly 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 being 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. 15 16 4.5. DOWNLOADING THE APPLICATION Download the application to your phone or tablet: - by the App store or Google Play Then click the MyTens icon. 4.6. STARTING AND USING Preparation of the treatment areas and installation of the stimulator 1. Before placing the electrodes, check that the skin does not show injury or redness and is healthy. tTranscutaneous electrical neurostimulation (TENS) programmes : Do not position the electrodes on irritated skin or skin with open wounds, rashes or cancerous lesions tElectrical 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 off 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 other. Note: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. 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. 17 Locating the electrodes Warning 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 vicinity 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 contraction 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. Standby mode, ready for the session). The App detects the stimulator which is switched on. In to begin a session. 3. Open the BW-TSX device and your APP,and the indicator on your APP transform red to green in fig. 3.1 below. And tap the button to known the information about "TENS" and "EMS", and then tap "OK" to continue, in fig.3.2 below. fig.3.1 fig.3.2 18 4. Choose between "Start Pain REliever (TENS) or Start Electro Stimulation (EMS)". At first-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. 7. Also, you can choose history treatment and settings. In the case of past use ofthe stimulator , you can start again the last session or choose another one in the history. 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. History Button According to the history treatment,you will get these information as follows: Treatment type; Zone; Time; Number of Mytens; Pain lever; Intensity lever; Satisfaction; Duration; And also, you can tap the setting button. 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. Srtting Button 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 flash 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 specified 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 20 When you finished your treatment: 1. 2. Remove the electrodes from the skin. Place the electrodes back on the liner. Detach from the edges. 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/off button before you remove the device or the electrodes. If you fail to do this, you may get an unpleasant sensation in your fingers when you touch the connectors. This sensation is not harmful, but it can be unpleasant. Replacement Electrodes Replace 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 MAINTENANCE 5.1. STORAGE OF THE ELECTRODES Put 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. CLEANING This device may be used for personal use. You should clean the device and electrodes after use. Warning : Never immerse the product in water and do not rinse it. Never immerse the elec 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. 21 22 - The use of accessories, transducers and cables other than those mentioned or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and increase the risk of malfunction 8. TECHNICAL CHARACTERISTICS Units 2 Units (49.9mmx55.8mm) Programmes 19 programmes (11 TENS + 8 EMS programmes) Battery 3.7V/500mAh Li-lon Output 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 hPa Storage and Transportation Conditions -10°C to 55°C with a relative humidity of 10% to 90%, atmospheric pressure of 700 to 1060 hPa Dimensions 440x54x13mm cable included Weight 55g (±20%) by unit 9. IMPORTANT INFORMATION REGARDING ELECTROMAGNETIC COMPATIBILITY (EMC) 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. IP22 Wave form Biphasic square wave (net current 0dc) Impulse width 150us~370us (±10%) Heart rhythm 2Hz~100Hz (±10%) Treatment time 22min/30min given by the application Adapter 1pc (Input : 100-240 V AC 50/60Hz Output : 5 V DC 300mA) Service life of the device 2 years Service life of electrode pads 10 times Applied part Eelctrode Electrode size 28*25mm(ellipse) Eelctrode impadence 23 ≤500Ω TABLE 1: Guidance and manufacturer’s declaration – electromagnetic emissions The customer or the user of these electrical stimulators should assure that it is used in such environment. 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 Harmonic emissions lEC 61000-3-2 Class A Voltage fluctuations/ flicker emissions lEC 61000-3-3 Complies 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. 24 TABLE 4: TABLE 2: Guidance and manufacturer’s declaration – electromagnetic IMMUNITY Guidance and manufacturer’s declaration – electromagnetic IMMUNITY The customer or the user of these electrical stimulators should assure that it is used in such environment. The 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 Electromagnetic Immunity test IEC 60601 test level Compliance level environment - guidance Electrostatic discharge (ESD) lEC 61000-4-2 ±6 kV contact ±8 kV air Electrical fast transient/burst IEC 61000-4-4 ±2 kV for power supply lines ±1 kV for input/ output lines Surge IEC 61000-4-5 ± 1 kV line(s) to line(s) ± 2 kV line(s) to earth <5% UT Voltage dips, short interruptions and voltage (>95% dip in UT) variations on power supply for 0.5 cycle input lines IEC 61000-4-11 Power frequency (50/60Hz) magnetic field IEC 61000-4-8 25 ±6 kV contact ±8 kV air ±2kV for power supply lines Mains power quality should be that of a typical commercial or hospital environment. Mains power quality ±1 kV differential should be that of a mode typical commercial or hospital environment. <5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec <5% UT (>95% dip in UT) for 5 sec 3 A/m Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. 3 A/m Mains 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 magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Conducted RF 3 Vrms lEC 61000-4-6 150 kHz to 80 MHz 3 Vrms Radiated RF lEC 61000-4-3 3 V/m 3 V/m 80 MHz to 2.5 GHz Portable and mobile RF Communications 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 distance d = 1.2 d = 1.2 80 MHz to 800 MHz d = 2.3 800 MHz 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). transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol: 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. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. 26 10. SAFETY PRECAUTIONS TABLE 6: Recommended separation distances between portable and mobile RF communications equipment and the device IP 22 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. Caution Garder au sec / Keep dry Refer to instruction manual. Note on the equipment “Follow instructions for use”. Separation distance according to frequency of transmitter Rated maximum output power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz d = 1.2 d = 1.2 800 MHz to 2.5 GHz d = 2.3 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 The first 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 effects when the enclosure is titled at any angle up to 15º， on either side of the vertical. Type BF applied part such as electrode The device, accessories and the packaging have to be disposed correctly at the end of the usage. Please follow local ordinances or regulations for disposal. Manufacturer SN Serial number This 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. 11. DISPOSAL 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. 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. 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. 27 28 12. PLACING THE ELECTRODES 12 Shoulder Shoulder pain and wrinkled shoulder Lumbar areas Pain in the lower back Elbow 29 Thigh Sciatic pain Knee Knee pain Lower leg Pain in the lower leg Ankle Pain in the ankle and Achilles tendon problem Foot Pain in the foot Pain in the elbow Forearm Pain in the forearm Wrist Pain in the wrist and carpal tunnel syndrome Hip Pain in the hip 30 Shoulder Resistance of the trapezoid Abdominal Resistance of abdominal muscles Lumbar areas Resistance of the lower back Forearm Hip Thigh Lower leg Resistance of the calf muscles Foot Training the foot 13. WARRANTY Bewell Connect Corp. will repair or replace this product free of charge in the case of defective parts or manu- facturing defects, in accordance with the conditions mentioned below as follows: DURATION: 24 MONTHS RETURN TO WORKSHOP Extender of the wrist and 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- Bender of the wrist and 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 Resistance of the hip muscle Resistance of the hamstring muscle equipment not approved by Bewell Connect Corp. or causes conrtary to those written in the user manual or notice. Moreover, the present guarantee does not cover damage due to falls, bad handling, bad incover 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 replacement of parts where wear is normal, are not covered by the terms of this guarantee. Bewell Connect -Corp. 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 Bewell Connect Corp , any other guarantee (commercial guarantee) except this one will not be taken nto account. contact the Bewell Connect Corp. customer service. 31 32
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