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.
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
-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.
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.
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.
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.
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.
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
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 (
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.
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.
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.
- 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.
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.
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.
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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.