TENS Stimulator Name: Shenzhen Dongdixin Technology Co., Ltd. Add: Floor 1-2, No.3 Building, Fanshen Xusheng Industrial Estate Xilixiaobaimang 518108 Nanshan District, Shenzhen P. R. China V1.1 2019 Introduction..................................................................................................................................... 2 Important information.................................................................................................................. 4 Safety information......................................................................................................................... 5 Important information.................................................................................................................. 7 Features.............................................................................................................................................11 Product structure............................................................................................................................12 Remote control...............................................................................................................................14 Battery information.......................................................................................................................15 Treatment information.................................................................................................................17 Cleaning and storage information............................................................................................. 22 Technical specification.................................................................................................................. 23 Program............................................................................................................................................. 25 Disposal ............................................................................................................................................ 26 Normalized symbols...................................................................................................................... 27 Troubleshooting............................................................................................................................. 29 Warranty.......................................................................................................................................... 31 Important information regarding electromagnetic compatibility (emc)........................ 32 FCC Compliance information.......................................................................................................38 TENS Stimulator TENS Stimulator IMPORTANT INFORMATION SAFETY INFORMATION Intended use The device is designed to be used for temporary relief of pain, including the acute and chronic pain. Contraindications 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. Warnings If you are in the care of a physician, consult your physician before you use this device. If you have had medical or physical treatment for your pain, consult your physician before you use 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 your physician. Consult your physician before you use this device. The device may cause lethal disturbances to the heart rhythm in susceptible individuals. Do not use the device if you have a cognitive impairment (e.g. dementia, Alzheimers disease). People who have a cognitive impairment may be unable to use the device according to the instructions and may become agitated by the treatment. Do not use the device on children, as it has not been evaluated for pediatric use. Do not use the device on the side of your neck (on the carotid sinus) or any area of the throat
(front of the neck). This could cause severe muscle spasms that may result in closure of your airway, breathing diculties, or adverse eects on heart rhythm or blood pressure. Do not use the device across your chest. The device introduces electrical current. Using the device in your chest may cause rhythm disturbances to your heart, which could be lethal. Use the device only on normal, intact, clean, and healthy skin. Do not use the device over open wounds or rashes, and over swollen, red, infected, or inamed areas or skin eruptions (e. g., phlebitis, thrombophlebitis, varicose veins). Do not use the device over, or close to, cancerous lesions. Do not place the electrodes inside body cavities, e.g. the mouth. This may cause skin irritation, skin burns or electrical shocks. This device is not designed for internal application. Do not use the device in the presence of electronic monitoring equipment (e.g., cardiac monitors, ECG alarms). This equipment may not operate properly when the electrical stimulation device is in use. SAFETY INFORMATION IMPORTANT INFORMATION Do not use this device over your eyes, mouth, face, front of neck (especially in the carotid sinus) or across your heart because this could cause severe muscle spasms resulting in closure of your airway, diculty breathing or adverse eects on heart rhythm or blood pressure. Do not use the device when in the bath or shower. Do not use the device while sleeping. Do not use the device while driving, operating machinery, or during any activity in which electrical stimulation can put you at risk of injury. Do not modify the device or the electrodes without authorization of the manufacturer. This could cause improper functioning. As the electrical performance characteristics of electrodes may aect the safety and eectiveness of electrical stimulation, take the following into account:
1. If the electrodes are too small or not correctly applied, this may result in discomfort or skin burn. 2. Contact the manufacturer of the device, if you do not know if the electrode can be used with the device. Precautions TENS is not eective 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. It suppresses the sensation of pain that normally serves as a protective mechanism. As TENS treatment may not be eective for everyone, consult your physician or healthcare professional to nd out if TENS will work in your case. The long-term eects of electrical stimulation are unknown. Because the eects of stimulation on the brain are unknown, do not use the device on opposite sides of your head. Electrical stimulation or the electrical conductive gel may cause skin irritation or hypersensitivity, the irritation can usually be reduced by alternate electrode placement. If you have suspected or diagnosed heart disease, follow the precautions from your physician. If you have suspected or diagnosed epilepsy, follow the precautions from your physician. Use caution if you are likely to have internal bleeding, for instance, after injuries or fractures. If you had surgery recently, consult your physician before you use the device. Using the device may disrupt the healing process. Use caution when you use the device over areas of skin that lack normal sensation. The impact of using this device during pregnancy is unknown. It may be not safe. Use caution when you use the device over the uterus during pregnancy or menstruation. IMPORTANT INFORMATION IMPORTANT INFORMATION Keep this device out of the reach of children. Do not use the device or an electrode if it is damaged. Always check the device and the electrodes for damage before use. Do not use plaster or tape to attach the electrodes to the skin. Make sure that the electrodes do not touch metal objects, such as belt buckles or necklaces. Use this device only with the electrodes, and accessories recommended by the manufacturer. Always end the device before you remove the device or the electrodes. If you do not end the treatment, you may get an unpleasant sensation in your ngers when you touch the buckle. This sensation is not harmful, but it can be unpleasant. Do not place on your spine or backbone. General recommendations Read this user manual carefully and always follow the treatment instructions. Do not use this device for any other purpose than what it is intended for. This device is designed for use by and on a single adult person. For hygienic reasons electrodes should not be shared. Do not use the device if you are connected to high-frequency surgical equipment. This may result in burns on the skin under the electrodes and may damage the device. Do not use the device within less than 39 inches (1 meter) from shortwave or microwave medical equipment. Close proximity to this equipment may cause unstable device output. Although you can use the device indoors and outdoors, it does not withstand all weather conditions. The electrodes have a limited shelf life. Please check the packaging for the use-by date before use. Do not use electrodes whose use-by date has expired. Always use and store the electrodes according to the instructions. Eectiveness is highly dependent upon patient selection by a practitioner qualied in the management of pain patients. You may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium (gel). RISKS General risk TENS only treats symptoms. It reduces the feeling of pain, but it does not cure the cause of the pain. Pain may be a signal from your body that some part of your body is damaged and needs attention. IMPORTANT INFORMATION Specific risks You may get skin irritation and burns under the electrodes applied to your skin. You may get a headache or other pain if you use the device near your eye, or on your head or face. You may experience muscle exhaustion or muscle soreness after extended use on the same muscles (more than 30 minutes a session, up to 3 times a day). Stop using the device and consult your physician if you experience adverse reactions from the device. To ensure safe usage of the device, follow the instructions in this user manual. Read the contraindications, warnings and precautions sections before you use this device. If you are not sure if the device is suitable for you, consult your physician before using this device. TENS Stimulator 5. Do not expose the device to any chemical solvent, water lint, direct sunshine or high temperature. Storage and transportation Conditions:
5 to 40; 30%RH to 75%RH; 700hpa to 1060hpa
-10 to 55; 10%RH to 90%RH; 700hpa to 1060hpa TENS Stimulator TENS Stimulator TENS Stimulator Service life of the device:
3 years Service life of the electrode pads:
10~15 times Service life of battery:
New batteries will last for approx.15 times Applied part:
Electrode NORMALIZED SYMBOLS Disposal in accordance with Directive 2012/19/EU(WEEE) Type BF applied part Please refer to instruction manual Serial number. The name and the address of the Authorized EC-representative in Europe 55
-10 Transportation and storage temperature from -10to 55 NORMALIZED SYMBOLS 90%
1060hPa 10%
700hPa Transportation and storage humidity limits from 10% to 90%
Transportation and storage atmospheric pressure limits from 700 hPa to1060 hPa Complies with the European Medical Device Directive
(93/42/EEC) and amended by directive 2007/47/EC requirements The name and the address of the manufacturer Date of manufacture 30 31 Important information regarding electromagnetic compatibility (emc) Important information regarding electromagnetic compatibility (emc)
. This device should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, this device should be observed to verify normal operation in the conguration in which it will be used. Use of accessories other than those specied or provided by the manufacturer of this device could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the device, including cables specied by the manufacturer. Otherwise, degradation of the performance of this equipment could result. When the operating environment is relatively dry, strong electromagnetic interference usually occurs. At this time, the device may be aected as follows:
- the device stops output;
- the device turns o;
- the device restarts;
The above phenomenon does not aect the basic safety and essential performance of the device, and the user can use it according to the instruction. If you want to avoid the above phenomenon, please use it according to the environment specied in the manual. Table 1 Declaration-electromagnetic emission The device is intended for use in the electromagnetic environment specied below. The customer or the user of device should assure that it is used in such an environment. Emissions test RF emissions CISPR 11 Compliance Group 1 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage uctuations/
icker emissions IEC 61000-3-3 Class B Not applicable Not applicable Electromagnetic environment-guidance 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. The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 32 33 Important information regarding electromagnetic compatibility (emc) Important information regarding electromagnetic compatibility (emc) Table 2 Declaration-electromagnetic immunity The device is intended for use in the electromagnetic environment specied below. The customer or the user of device should assure that it is used in such an environment. Immunity test IEC 60601test level Compliance level Electrostatic discharge (ESD) IEC 61000-4-2 8 kV contact 2 kV, 4 kV, 8 kV, 15 kV air 8 kV contact 2 kV, 4 kV, 8 kV, 15 kV air Electrical fast transient/burst IEC 61000-4-4 2 kV for power supply 1 kV for input/output lines Not applicable Surge IEC 61000-4-5 0.5kV,1 kV line
(s) to lines 0.5kV, 1 kV, 2kV line(s) to earth Not applicable Electromagnetic environment guidance Floors should be wood, concrete or ceramic tie. If oors are covered with synthetic material, the relative humidity should be at least 30 %. Mains power quality should be that of a typical commercial or hospital environment. Mains 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 Power frequency
(50/60 Hz) magnetic eld IEC 61000-4-8 Not applicable 0 % UT; 0.5 cycle At 0,45, 90, 135, 180, 225, 270and 315 0 % UT; 1 cycle and 70 % UT;
25/30 cycles Single phase: at 0 0 % UT; 250/300 cycles 30 A/m 30 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 batter. Power frequency magnetic elds should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE: UT is the a.c. mains voltage prior to application of the test level. 34 35 Important information regarding electromagnetic compatibility (emc) Important information regarding electromagnetic compatibility (emc) Table 3 Declaration-electromagnetic immunity The device is intended for use in the electromagnetic environment specied below. The customer or the user of device should assure that it is used in such an environment. Immunity test IEC 60601test level Compliance level Conducted RF IEC 61000-4-6 Not applicable 3V 0.15 MHz to 80MHz 6 V in ISM and amateur radio bands between 0.15 MHz and 80 MHz Electromagnetic environment-
guidance Portable and mobile RF communications equipment should be used no closer to any part of device, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Radiated RF IEC 61000-4-3 10V/m 80 MHz to 2.7 GHz 10V/m d d d P P 2.1=
2.1=
3.2=
150 KHz to 80 MHz 80 MHz to 800 MHz 80 MHz to 2.7 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is P the recommended separation distance in meters (m). Field strengths from xed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from structures, objects and people. a Field strengths from xed RF 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 xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in which device is used exceeds the applicable RF compliance level above, device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating device. b Over the frequency range 0.15 MHz to 80 MHz, eld strengths should be less than 3 V/m. 36 37 Important information regarding electromagnetic compatibility (emc) Important information regarding electromagnetic compatibility (emc) Table 4 Recommended separation distances between portable and mobile RF communications equipment and device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and device, as recommended below, according to the maximum output power of the communications equipment. For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from structures, objects and people. Rated maximum output power of transmitter W 0.01 0.1 1 10 100 36 Separation distance according to frequency of transmitter m 80 MHz to 800 MHz d 0.15 MHz to 80 MHz d 3.2=
P P d 80 MHz to 2.7GHz 80 MHz to 2.7 GHz 2.1=
0.12 P 0.23 2.1=
0.12 0.38 1.2 3.8 12 0.38 1.2 3.8 12 0.73 2.3 7.3 23 37 FCC Compliance information FCC Compliance information FCC Radiation Exposure Statement This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be colocated or operating in conjunction with any other antenna or transmitter. 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. Changes or modications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. 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 dierent from that to which the receiver is connected Consult the dealer or an experienced radio/TV technician for help. 38 39