Guangzhou Longest Science and Technology LGT-231 Portable Electro-Stimulation Therapy Device User Manual
Guangzhou Longest Science & Technology Co., Ltd. Portable Electro-Stimulation Therapy Device Users Manual
Users Manual
Portable Electro-Stimulation Therapy Device USER MANUAL LGT-231 Guangzhou Longest Science & Technology Co., Ltd. TABLE OF CONTENTS Foreword ............................................................................................................................................ 4 Safety Instructions ............................................................................................................................. 6 EMC Guidance................................................................................................................................. 17 Clinical Instructions .......................................................................................................................... 25 Working Principle ............................................................................................................................. 27 Inspection of the Goods ................................................................................................................... 28 Overview of the Unit ........................................................................................................................ 30 MStim Reha Application ................................................................................................................... 35 Operation Guidance ......................................................................................................................... 57 Care and Maintenance .................................................................................................................... 60 Troubleshooting ............................................................................................................................... 63 Technical Specifications................................................................................................................... 66 Assistance and Spare Parts............................................................................................................. 71 Warranty .......................................................................................................................................... 72 Foreword Thank you for purchasing the LGT-231 Portable Electro-Stimulation Therapy Device from our company. This manual has been written for the owners and operators of the LGT-231 Portable Electro-Stimulation Therapy Device. It contains general information on the instructions for safety, intended use, working principle, operation, maintenance, troubleshooting, and warranty. In order to maximize the use, efficiency, and working life of your unit, please read this manual thoroughly and become familiar with the controls, as well as the accessories, before operating the unit. Specifications put fifth in this manual were in effect at the time of publication. However, owing to policy of continual improvement by Guangzhou Longest Science & Technology Co., Ltd., any changes to these specifications may be made at any time without obligation on the part of Guangzhou Longest Science & Technology Co., Ltd. Before administering any treatment to a patient, the user of this equipment should read, understand, and follow the information contained in this manual for each mode of treatment available, as well as the indications, contraindications, warnings, and precautions. Product Description The LGT-231 Portable Electro-Stimulation Therapy Device is a lightweight and portable multifunctional electrotherapy device that provides two channels of TENS, NMES current, or one channel of MCR current. It utilizes the low electric-current to stimulate muscle nerve to stimulate nerve and muscle tissue, relieve pain and promote blood circulation, help improve symptoms, relieve pain, restore and strengthen neuromuscular function. Safety Instructions Symbols 1. Symbols on the medical device Symbols Explanation Manufacturer Date of manufacture EU Representative This product complies with European Directive 93/42 EEC for medical products. (0598 is the notified body number) Correct Disposal of This Product (Waste Electrical & Electronic Equipment) Statement: Contact the local authorities to determine the proper method of disposal of potentially bio-hazardous parts and accessories. Type BF applied part (i.e. electrode) complying with IEC60601-1. Protected against solid foreign objects of 12.5 mm (0.5 in) diameter and greater; Protected against vertically falling water drops when enclosure tilted up to 15°. This device emits non-ionizing radiation. Refer to instruction manual/ booklet Caution output. It is placed near all electrode connections. 2. Symbols on the package Symbols Explanation This side up The transportation package must be vertical and straight up during transportation. Fragile, handle with care The product inside the packaging could be easily damaged if dropped or handled without care and attention. Keep away from rain The product package should keep out of the rain and not to store it in damp conditions. Temperature limitation The product package should be stored at a temperature between -20 and 55 degrees (centigrade). Upper limit of humidity The product package should be stored at a humidity less than 93%. Atmospheric pressure limitation The product package should be stored at an atmospheric pressure between 86kPa and 106kPa. Precautionary Definitions The precautionary instructions found in this section and throughout this manual are indicated by specific symbols. Understand these symbols and their definitions before operating this equipment. The definition of these symbols is as follows: Text with a “CAUTION” indicator will explain possible safety infractions that could have the potential to cause minor to moderate injury or damage to equipment. Text with a “WARNING” indicator will explain possible safety infractions that will potentially cause serious injury and equipment damage. Text with a “DANGER” indicator will explain possible safety infractions that are imminently hazardous situations that would result in death or serious injury. Explosion Hazard Text with an “Explosion Hazard” indicator will explain possible safety infractions if this equipment is used in the presence of flammable anesthetics. Dangerous Voltage Text with a ”Dangerous Voltage” indicator serves to inform the user of possible hazards resulting in the electrical charge delivered to the patient or operator in certain treatment configurations. Refer to Instruction Manual/Booklet NOTE: Throughout this manual, “NOTE” may be found. These Notes are helpful information to aid in the particular area or function being described. 10 Warnings and cautions Please carefully read and understand the following warnings and cautions to ensure the safe and correct use of the LGT-231 and to prevent injury. Read, understand, and practice the precautionary operating instructions. Know the limitations and hazards associated with using the LGT-231. Observe the precautionary and operational decals placed on the unit. Before using LGT-231 make sure you have read and understood all information provided in this manual. Familiarity with the information included in this manual is an essential requirement to ensure efficient and optimal use of the system, to avoid dangers to persons and to the equipment, and to obtain good treatment results. Improper installation, operation, or maintenance of the LGT-231 may result in malfunctions of this unit or other devices. In case of display failure or other obvious defects, switch the unit off immediately, and notify a certified service technician. Adjustments or replacement of components may result in the equipment failing to meet the requirements for interference suppression. 11 This LGT-231 should be kept out of the reach of children. Do not use this unit near the heart or chest, above the neck, on the head, around the mouth or on diseased skin; The placement of the electrodes can be referenced to the reference icon provided by APP, Note that the following parts cannot be placed: a) carotid sinus (current may affect blood pressure and cardiac contraction, causing arrhythmia); b) c) d) e) f) g) infection site (which may aggravate the infection); pregnant women's abdomen and lumbosacral (may cause uterine contractions); surgical site (muscle contraction may cause wound dehiscence); malignant neoplasms; sensory defects or parts that are allergic to the electrodes; eye. Do not use this unit for purposes other than treatment indicated in this manual. Do not use the LGT-231 with high frequency surgical equipments on the patient. It will cause unstable output when the unit is close to the high frequency equipments (in the same room and without shield). Do not use this device simultaneously with other therapeutic device (such as microwave), to avoid mis-operation. 12 Do not use electrodes with an active area of less than 25 cm²(when you choose the TENS or NMES mode) due to the risk of associated burning. Proceed systematically with caution when the density of the current is over 2 mA/ cm². Do not modify this device without authorization of the manufacturer. Only use this device with the charger, cables, electrodes and accessories recommended by the manufacturer. The LGT-231 contains built-in batteries that cannot be removed by the user. Do not replace it by yourself to avoid damage the batteries or device. If necessary, please contact the company or the company authorized maintenance personnel to replace. Please dispose of the equipment and other accessories according to local regulations. Do not treat them as household waste. Do not put the device in fire or water. If the batteries are not properly disposed, it may cause a battery explosion. Do not use when the unit is charging. Always check the device and the electrodes for damage before use. If the unit is not functioning properly or you feel discomfort, immediately stop using the unit. If you feel any trouble with your body or skin, consult the doctor and follow his/her instructions. The self-adhesive electrode limited to the same person to use, do not use in another patients 13 to prevent infection. If the electrode loses viscosity, please replace the electrode in order to maintain good electrical properties. Do not use this unit in places with high humidity such as the bathrooms or while taking a bath or shower. Do not use this unit while sleeping. The main unit may develop trouble, or the pad may move to an unexpected region and cause ill health. Clean the device using a dry soft cloth. Do not use cleaning solvents or other chemical substances in order to avoid any damage. Make sure that you end the treatment by switching off the units or by setting the intensity to 0 mA before you remove the units or the electrodes. If you do not end the treatment, you may experience an unpleasant sensation in your fingers. This sensation is not harmful, but can be unpleasant. Handle the unit with care. Do not drop, knock, or shake the unit. Rough handling can damage internal circuit boards. Do not apply stimulation while driving, operating machines or while performing any other activity in which electrical stimulation can put you at risk of injury. Always disconnect the power charger from the mains after use. 14 FCC Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. 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. 15 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. FCC RF warning statement: The device has been evaluated to meet general RF exposure requirement. The device can be used in portable exposure condition without restriction. This device and its antenna(s) must not be co-located or operation in conjunction with any other antenna or transmitter. FCC ID: 2ANHPLGT-231 16 EMC Guidance This product needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided, and this unit can be affected by portable and mobile RF communications equipment. Do not use a mobile phone or other devices that emit electromagnetic fields, near the unit. This may result in incorrect operation of the unit. This unit has been thoroughly tested and inspected to assure proper performance and operation! This machine should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, this machine should be observed to verify normal operation in the configuration in which it will be used. 17 Accessory Information: Item Cable Length Power cord (adapter) 0.96 m Manufacturer & Address Shenzhen Hongyi Electronic Technology Co., Ltd. A05-1, 2/F, 3 Bldg, EC building, Yu Anju, Baoan District, Shenzhen, China Guangzhou Longest Science & Technology Co., Ltd. Electrode lead hose 1.2 m 5&6F, Building B4, No.11, Kaiyuan Avenue, Science City, Guangzhou Hi-tech Industrial Development Zone, 510530 Guangzhou, Guangdong Province, P.R. China Bluetooth Specifications: Bluetooth version: 4.0 single mode Frequency Range: 2.402GHz ~ 2.480GHz Output Power: 1mW 18 Guidance and manufacture’s declaration – electromagnetic emission The LGT-231 is intended for use in the electromagnetic environment specified below. The customer of the user of the LGT-231 should assure that it is used in such an environment. Emission test Compliance Electromagnetic environment – guidance The LGT-231 use RF energy only for its internal RF emissions Group 1 CISPR 11 function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emission Class B CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage LGT-231 establishments, Class A is suitable for including use in all domestic establishments and those directly connected to the public low-voltage pump supply network that fluctuations/ flicker emissions The Complies supplies buildings used for domestic purposes. IEC 61000-3-3 19 Guidance and manufacture’s declaration – electromagnetic immunity The LGT-231 is intended for use in the electromagnetic environment specified below. The customer or the user of LGT-231 should assure that it is used in such an environment. IEC 60601 test Electromagnetic environment Immunity test Compliance level level - guidance Electrostatic ±6 kV contact ±6 kV contact Floors should be wood, concrete discharge ±8 kV air ±8 kV air or ceramic tile. If floor are (ESD) covered with synthetic material, IEC 61000-4-2 the relative humidity should be at least 30%. Electrical fast ±2 kV for power ±2kV for power Mains power quality should be transient/ burst supply lines supply lines that of a typical commercial or IEC 61000-4-4 ±1 kV for hospital environment. input/output lines Surge ± 1 kV line(s) to ±1 kV differential Mains power quality should be IEC 61000-4-5 line(s) mode that of a typical commercial or ± 2 kV line(s) to hospital environment. earth Voltage dips, <5% UT (>95% dip <5% UT (>95% dip Mains power quality should be short in UT) for 0.5 cycle in UT) for 0.5 cycle that of a typical commercial or interruptions hospital environment. If the user 40% UT (60% dip in 40% UT (60% dip in and voltage of the LGT-231 requires 20 variations on power supply input lines IEC 61000-4-11 UT) for 5 cycles UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec Power frequency (50Hz/60Hz) 3 A/m magnetic field IEC 61000-4-8 NOTE 3 A/m continued operation during power mains interruptions, it is recommended that the LGT-231 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. UT is the a.c. mains voltage prior to application of the test level. 21 Guidance and manufacture’s declaration – electromagnetic immunity The LGT-231 is intended for use in the electromagnetic environment specified below. The customer or the user of the LGT-231 should assure that it is used in such an environment. Immunity IEC 60601 Compliance Electromagnetic environment - guidance test test level level Portable and mobile RF communications equipment should be used no closer to any part of the LGT-231, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.2 √P Conducted RF 3 Vrms 3 Vrms IEC 61000-4-6 150 kHz to 80 MHz Radiated RF 3 V/m IEC 61000-4-3 80 MHz to 3 V/m d = 1.2 √P 80 MHz to 800 MHz d = 2.3 √P 800 MHz to 2.5 GHz 2.5 GHz Where P is the maximum output power rating of 22 the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF 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 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 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 LGT-231 is used exceeds the applicable RF compliance level above, the LGT-231 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the LGT-31. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. 23 Recommended separation distances between portable and mobile RF communications equipment and the LGT-231 The LGT-231 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the LGT-231 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the LGT-231 as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter (m) Rated maximum output power of 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz transmitter (W) d = 1.2 √P d = 1.2 √P d = 2.3 √P 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (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 80MHz and 800MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 24 Clinical Instructions Before a treatment with the LGT-231 Portable Electro-Stimulation Therapy Device, a correct examination and diagnosis should be performed. Indications The LGT-231 Portable Electro-Stimulation Therapy Device can alleviate acute and chronic pain, also can stimulate nerves and muscles, causing muscle contraction. Contraindications Patients with the following disease are forbidden to use the LGT-231 Portable Electro-Stimulation Therapy Device: 1) Patient with severe heart failure or arrhythmia, and patient with pacemaker; 2) Patient with venous thrombosis or thrombophlebitis; 3) Patient who is in the acute or critical stage of important organ disease; 4) Patient whose treatment area with bleeding tendency ,metal matter or tuberculous lesions; 5) Patients who cannot provide sensory feedback for stimulation (unable to express or have difficulty in communication),such as mental disease. 25 Adverse Effects You should stop using the device and consult your doctor if you experience adverse reactions from the device. Possible adverse reactions may include the following: skin irritation beneath the electrodes; burns beneath the electrodes; headaches or other painful sensations. 26 Working Principle Display Screen Communication of Mobile Phone APP and Bluetooth PWM Intensity Adjustment Bluetooth Chip Processor AC Input Power Adapter Battery Pulse Generating Current Feedback Button 27 Electrode Inspection of the Goods 1. Unpacking the Unit The unit is generally delivered with the packaging material supplied by the manufacturer. Proceed as follows: Position the transport packaging so that the arrows are pointing upward. Remove the transport packaging upward. Remove the remaining foam material. 2. Inspections Immediately upon unpacking the unit, perform the following steps: 1) 2) Verify the delivery documents to make sure that the delivery is complete. Check the LCD touch screen of the unit when unpack the packaging and make sure it is in good condition. Any scratch on the surface during use will be not covered in the warranty. 3) 4) Check the external components and accessories for possible damage due to transport. Verify that the packaging contains the following: 28 NO. Item Name Amounts Unit LGT-231 main unit piece Power adapter piece Electrode lead hose pieces pieces Self-adhesive electrode with magnetic 50mm×50mm (square) connection: Certificate of quality piece Warranty card piece Installation checklist piece User manual piece Other parts of LGT-231 are available as accessory on demand. Visit website www.longest.cn to obtain more information. 29 Overview of the Unit 1. Nomenclature 30 1 Increasing intensity of CH2 Indicator light: see table: meaning of indicator light Increasing intensity of CH1 Decreasing intensity of CH1 ON/ OFF button Decreasing intensity of CH2 10 Display screen: Displays various setting parameters and treatment parameters Output sockets of CH1: connect electrode lead hose Output sockets of CH2: connect electrode lead hose Micro-USB port: connect power adapter. Slide the slider to output sockets when charging. Table: meaning of indicator light Status Power off Ready Indicator colour None Green Stimulation on Blue Low battery cannot be used Charging Fully charged Electrodes fall off during treatment Way of flashing Yellow Green None Flash at 1Hz frequency The flash frequency is consistent with the output pulse frequency Flash at 3 Hz frequency for 1s, and then turn off the unit. Always bright Always bright Yellow Flash at 1Hz frequency Yellow 31 2. Display screen of the unit Bluetooth icon: When the unit does not connect the APP about 3 minutes later, the icon will disappear, means that the unit has turn off Bluetooth. You have to restart the unit to connect the APP. Pulse Frequency Battery status display Output intensity of CH2: When the channel is not selected, the will display”-mA” Residual time indicator Output intensity of CH1: When the channel is not selected, the will display”-mA” Pulse Duration 32 3. Accessories 3.1 Electrode lead hose The electrode lead hose connect with the main unit and electrodes. 3.2 Self-adhesive electrode with magnetic connection 33 ON. Item name Remark Self-adhesive electrode with magnetic connection: 50mm×50mm (square) Self-adhesive electrode with magnetic connection: Φ32mm (round) Self-adhesive electrode with magnetic connection: Φ50mm (round) Self-adhesive electrode with magnetic connection: 40mm×60mm (rectangle) Self-adhesive electrode with magnetic connection: 50mm×90mm (rectangle) Self-adhesive electrode with magnetic connection: 80mm×130mm (rectangle) 34 Standard Optional Optional Optional Optional Optional MStim Reha Application LGT-231 Portable Electro-Stimulation Therapy Device can only be used with the software provided by our company. Name of the software: MStim Reha Release Version: 1 Software operating environment: Android 4.3 or later mobile phone, with 4.0 Bluetooth. iOS 8 or later iPhone mobile phone, with 4.0 Bluetooth. 35 1. Install MStim Reha Application Click the MStim Reha Application installation package (APK file) on your phone, and follow the prompts to install the application. 2. Open MStim Reha Application After the MStim Reha Application is installed properly, it will appear on your phone desktop. Click the icon and the main interface of the MStim Reha appear, as shown on the left. 36 3. Connect the Device Click “connect the device” to connect MStim Reha Application which on the phone and the device via Bluetooth. 37 4. Main Interface Open MStim Reha, you can see the main interface, as shown on the left. There are three modes on the MStim Reha: TENS Mode, NMES Mode and MCR Mode. 38 4.1 TENS Interface 1) Enter TENS interface Click TENS at the main interface to enter the TENS interface, as shown on the left. 2) Select output channel Select single or dual channel outputs as needed. 3) Choose output mode TENS has four output modes: Normal, Sweep, Random and Alternation mode. The Alternate mode is only used for dual channel output. The parameters of each mode are shown in Table: TENS parameter setting. 39 Table: TENS parameter setting Output Mode: Normal Output Mode: Sweep parameter setting Range Default Stepping parameter setting Range Default Stepping Frequency Hz 1-100 40 Frequency Hz 1-100 40 Pulse Duration μs 50-50 300 10 Pulse Duration μs 50-500 300 10 Burst Frequency Hz 1-5 Sweep time s 15-60 30 15 Treatment time min 1-60 10 Treatment time min 1-60 10 Output intensity mA 0-100 Output intensity mA 0-100 Output Mode: Random Output Mode: Alternation parameter setting Range Default Stepping parameter setting Range Default Stepping Frequency Hz 1-100 40 Frequency Hz 1-100 40 Pulse Duration μs 50-500 300 10 Pulse Duration μs 50-500 300 10 Treatment time min 1-60 10 Alternation time s 1-9 Output intensity mA 0-100 Treatment time min 1-60 10 Output intensity mA 0-100 NOTE: The output intensity can only be adjusted after starting. 40 4) Start treatment When the parameter is set, click the start button to start the treatment. 5) Adjust output intensity Click the start button, the output intensity can be adjusted. Click 41 button, interface pop-up tip: 6) locking interface The APP locks automatically after some time of inactivity to prevent accidental operation. Just press the avatar swipe screen to unlock. 7) End of the treatment At the end of the treatment, the unit stops output and returns to the pre start state. The indicator is switched from blue to green and flashes at 1Hz frequency, while the mobile application interface shows "the treatment is finish." 42 4.2 NMES Interface 1) Enter NMES Interface Click NMES at the main interface to enter the NMES interface, as shown on the left. 2) Select output channel Select single or dual channel outputs as needed. 3) Choose output mode NMES has two output modes: Synchronize output and Alternate output mode. The Alternate mode is only used for dual channel output. The parameters of each mode are shown in Table: NMES parameter setting. NOTE: You can choose output mode only select the dual channel outputs. 43 4) NMES parameter setting Table: NMES parameter setting parameter setting Range Default Stepping Frequency Hz 1-120 40 Pulse Duration μs 50-500 300 10 Ramp up time s 0.5-5.0 1.0 0.5 Hold time s 1.0-30.0 3.0 1.0 Ramp down time s 0.5-5.0 1.0 0.5 5-60 10.0 1.0 Treatment time min 1-60 10 Output Intensiyt mA*-2 0-100 Surge Modulation*-1 Interval time s -1 * The Surge Modulation Interface is as shown on the left. *-2 The output intensity can only be adjusted after starting. 44 5) Start treatment When the parameter is set, click the start button to start the treatment. 6) Adjust output intensity Click the start button, the output intensity can be adjusted. Click 45 button, interface pop-up tip: 7) End of the treatment At the end of the treatment, the unit stops output and returns to the pre start state. The indicator is switched from blue to green and flashes at 1Hz frequency, while the mobile application interface shows "the treatment is finish." 46 4.3 MCR Interface Click MCR at the main interface to enter the MCR interface, as shown on the left. Table: MCR parameter setting parameter setting Range Default Stepping Frequency Hz 1-100 50 Treatment time min 1-60 10 Output intensity μA 0-1000 10 NOTE: The output intensity can only be adjusted after starting. 47 5. Open circuit tip When the treatment electrode is disconnected, the device appears with the following prompt, please re-paste the electrode. 48 6. Help Click the icon in the upper right corner of the main interface, or slide the interface in the main interface to see more, click the icon interface. 49 , enter the help 6.1 Using guidance There is some introduction of how to operation the LGT-231 Portable Electro-Stimulation Therapy Device in using guidance, which is convenient for you to understand the use of device. 50 6.2 Common problem MStim Reha Application includes a variety of common problems, you can learn more about the LGT-231 Portable Device and treatment. 51 Electro-Stimulation Therapy 7. Preset protocols 7.1 Add protocols MStim Reha Application internally installed 21 preset protocols. You can click “Preset protocols” to enter the interface. You can click “Add more protocols”, choose the protocols you need, and then click OK button, the operation as following pictures. 52 7.2 Delete or sort the protocols To delete a protocol, click the "Edit" button and click " to delete it. To sort the protocols, press and hold " to drag the prescription. Click "Finish" when finished. 53 7.3 Treatment from the preset protocols Choose the right protocol for treatment as needed. For example, select "Cerebral stroke NMES", as shown in the following figure. FOR-MRRD0001-EN231 UM0.1 Please click the color area to select the treatment parts, and then click OK button to enter the treatment parameters interface. You can modify the parameters as need, and then click “start treatment”. FOR-MRRD0001-EN231 UM0.1 Operation Guidance 1. Preparing for use 1.1 Charging the unit To be able to use the device, you first have to charge the unit. Put one side of power adapter connects with the unit; another side connects with the power socket. The status indicator on the unit flashes yellow during charging. The status indicator stops flashing turn to green when the battery is fully charged. NOTE: If the rechargeable battery of the units is not fully charged when you start a treatment, the batteries may run out during the treatment. We advise you to always fully charge the unit before you start a treatment. NOTE: Always disconnect the power charger from the mains after use. Do not use when the unit is charging. FOR-MRRD0001-EN231 UM0.1 1.2 Turn on the unit Press the ON/OFF button to turn on the unit to standby. 1.3 Open the MStim Reha and connecting Turn on the MStim Reha Application on your phone and connect the unit to your phone via Bluetooth. 1.4 Clean the skin Use alcohol or soapy water to clean the skin. 1.5 Place the electrodes Place electrodes according to reference or actual conditions. 1.6 Connect the unit Connect one end of electrode lead hose to the electrodes, the other end to the unit. 2. Starting a Treatment 2.1 Parameter Setting According to the actual situation, choose the appropriate electrical stimulation therapy or protocol, set the treatment parameters, treatment time, etc. (see the chapter MStim Reha Application) 2.2 Press the START button FOR-MRRD0001-EN231 UM0.1 Click the start button and the treatment begins. 2.3 Adjust output intensity You can adjust the output intensity in the MStim Reha interface, or through "+/-" button on the unit. The output intensity should be increased slowly from small values to avoid excessive stimulation. Since your body initially adapts to the intensity of the stimulation, you may have to adjust the intensity level after some time to ensure optimal stimulation. 2.4 The End of Treatment At the end of the treatment, the unit stops output and returns to the pre start state. The indicator is switched from blue to green and flashes at 1Hz frequency, while the mobile application interface shows "the treatment is finish." Remove the electrodes after treatment, paste it back to the plastic film and store the unit well. FOR-MRRD0001-EN231 UM0.1 Care and Maintenance 1. Cleaning 1) 2) Please turn off the device before the cleaning and disinfection operation; For the main unit cleaning, what recommended are a clean, soft damp cloth for stains, and a clean, soft dry cloth for dust in the surface of the main unit. Do not clean the main unit with organic solvent such as gasoline or diluents, otherwise damage will be happened to the main unit such as deformation and falling off of the paint. 2. Routine Maintenance If it is used in accordance with the instructions of the user manual, the device does not need a particular regular maintenance. Manufacturer will provide circuit diagrams, component part lists, descriptions, calibration instructions to assist to service personnel in parts repair. The unit and accessories must be checked at regular intervals. FOR-MRRD0001-EN231 UM0.1 1) Check the power line to ensure if there is no distortion, fracture, etc. These circumstances may cause fire hazard. Please replace a new power line immediately. 2) Replace the electrodes if: -- they are damaged or torn. -- they are past the use-by date. -- they have lost their adhesive power. Never use plaster or tape to attach them to your skin. -- stimulation feels less strong. -- when the 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. Never perform unauthorized service work. All service work must be performed only by service technicians who have been authorized by the manufacturer. FOR-MRRD0001-EN231 UM0.1 3. DISPOSAL For environmental reasons, do not dispose of the device in the household waste at the end of its useful life. Dispose of the unit at a suitable local collection or recycling point. Dispose of the device in accordance with EC Directive – WEEE (Waste Electrical and Electronic Equipment). If you have any questions, please contact the local authorities responsible for waste disposal. FOR-MRRD0001-EN231 UM0.1 Troubleshooting This chapter summarizes the most common problems you could encounter with the LGT-231 Portable Electro-Stimulation Therapy Device. If you are unable to solve the problem with the information below, please call the distributors. Troubles Possible causes Solutions 1. LCD Display does not light up at all when press the ON/OFF button 2. The MStim Reha APP on the mobile phone could not connect with the unit. The battery of the unit is empty. Charge the unit (see chapter Preparing for use’). 1. The unit is not turn on; 2. Mobile phone Bluetooth is not open or mobile phone Bluetooth problems 3. the distance of the mobile phone and the unit is too far; 4. The unit has contacted another mobile. The unit is asleep and Bluetooth is stopped. 1. Turn on the unit; 2. Please turn on the Bluetooth on the mobile phone or change another mobile phone; 3. Please keep the mobile phone near the unit; 4. Disconnect the connected phone or restart the unit; 5. Restart the unit. FOR-MRRD0001-EN231 UM0.1 Troubles Possible causes Solutions 3. The status indicator on the unit flashed Yellow and the unit switched off. 4. There is not output. The battery of the unit is empty. Charge the unit (see chapter Preparing for use’). 1. Did not press the start button; 2. Did not adjust the output intensity; 3. The electrode lead hose connected badly; 4. The electrode lead hose has been damaged. 1. The output intensity is too high; 2. Electrodes are too close together; 3. Damaged or worn electrodes or electrode lead hoses; 4. Electrode active area size is too small. 1. Press the start button; 2. Adjust the output intensity; 3. Re-connect the electrode lead hose; 4. Replace a new electrode lead hose. 5. Stimulation uncomfortable. is 1. Decrease the output intensity; 2. Reposition the electrodes; 3. Replace; 4. Replace electrodes with ones that have an active area no less than 25.0cm2. FOR-MRRD0001-EN231 UM0.1 Troubles Possible causes Solutions 6. The MStim Reha APP on the mobile phone pop up tips “electrodes fall off”, the indictor of the unit flashed Yellow. 1. The electrode lead hose connected badly; 2. The electrodes are poor contact with the skin. Electrodes do not stick well; 7. The unit has output, but treatment without sensation. The output intensity is too low. 1. Re-connect the electrode lead hose; 2. Re-connect the electrodes. Replace electrodes. Apply electrodes to a clean, dry surface. Increase the output intensity. FOR-MRRD0001-EN231 UM0.1 Technical Specifications 1. Stimulator Output Parameters 1.1 TENS Parameters Channels: Dual, separate output intensity control levels for each channel. Output Mode: Normal, Burst, Sweep, Random, Alternation mode Output Waveform: Symmetrical biphasic asynchronous Pulse Duration: Adjustable, 50μs-500μs, stepping 10μs, ±20% tolerance Pulse Frequency: Adjustable, 1Hz-120Hz (Normal mode: 1Hz-100Hz, Burst mode: 20Hz-100Hz), stepping 1Hz, ±1Hz tolerance Burst frequency: Adjustable, 1Hz-5Hz, stepping 1Hz, ±10% tolerance (Burst mode) Sweep time: Adjustable, 15s-60s, stepping 15s, ±5s tolerance (Sweep mode) Alternation time: Adjustable, 1s-9s, stepping 1s, ±10% tolerance (Alternation mode) Output intensity: Adjustable, 0mA-100mA(p-p), stepping 1mA, ±5mA or ±10% tolerance (at 500Ω load) Maximum Current the maximum current will be limited to 50mA r.m.s.at 500 Ω Load (r.m.s): FOR-MRRD0001-EN231 UM0.1 1.2 NMES Parameters Channels: Dual, separate output intensity control levels for each channel. Output mode: Synchronize output, Alternate output mode Output Waveform: Symmetrical biphasic asynchronous Pulse Duration: Adjustable, 50μs-500μs, stepping 10μs, ±20% tolerance Pulse Frequency: Adjustable, 1Hz-120Hz, stepping 1Hz, ±1Hz tolerance Surge Modulation: Parameter Range Stepping Tolerance Ramp up time (s) 0.5-5.0 1.0 0.5 Hold time (s) 1.0-30.0 3.0 1.0 Ramp down time (s) 0.5-5.0 1.0 0.5 2-60 10.0 1.0 Interval time (s) Output intensity: Adjustable, 0mA-100mA(p-p), stepping 1mA, ±5mA or ±10% tolerance (at 500Ω load) Maximum Current the maximum current will be limited to 50mA r.m.s.at 500 Ω Load (r.m.s): FOR-MRRD0001-EN231 UM0.1 1.3 MCR Parameters Channels: One channel Output Waveform: Symmetrical biphasic asynchronous Pulse Frequency: Adjustable, 1Hz-100Hz, stepping 1Hz, ±1Hz tolerance Pulse Duration: 50% of Output Cycle, ±10% tolerance Output intensity: Adjustable, 0μA -100μA, stepping 10 μA, ±1 mA or ±10% tolerance, take larger values (at 500Ω load) Maximum Current the maximum current will be limited to 5mA r.m.s.at 500 Ω Load (r.m.s): 1.4 Timer a) b) c) Treatment time: 1min-60min, stepping 1min; Timer tolerance: ±2%; When finish, the device can stop output and prompt. 1.5 Software Function a) b) has 21 preset protocols; has battery level display function. FOR-MRRD0001-EN231 UM0.1 2. Other specifications Product Name Portable electro-stimulation therapy device Model LGT-231 Power supply: Adapter model: HYI11-005 Adapter supply voltage: AC100-240V, 50/60Hz; Adapter output: DC 5V, 2A. Battery: 3.7V, 1400mAh, lithium battery. Line Current Isolation: Patient disconnected when charging. Expected life The expected life of the main unit is five years under normal usage. (Except for man-made damage). The Date of product manufacture see label on the device. The expected life of the electrode lead hose is 12 months under normal usage. (Except for man-made damage). Cycle time of electrodes: Usage varies depending on your skin type. We recommend that you keep your skin clean and dry when you use it, usually around 20-30 times. Rate power : 6VA FOR-MRRD0001-EN231 UM0.1 Dimension: 62mm (W) × 122mm (L) × 27mm (H) Weight: 120g (only main unit) Classification: Classification (IEC 60601-1): Class II, Type BF Applied Part; Ingress Protection: IP22; Mode of operation: Continuous. Temperature: 5 to 40℃; Rel. humidity: ≤80%; Atmosphere Pressure: 86.0 to 106.0kPa. and storage: Temperature: -20 to 55℃ Rel. humidity: ≤93% Atmosphere Pressure:86.0 to 106.0kPa Works with: Requires a smart phone with Bluetooth 4.0, Android 4.3 (or later) or iOS Environmental conditions of operation: Environmental conditions of transport 8 or later. FOR-MRRD0001-EN231 UM0.1 Assistance and Spare Parts Every intervention on device must be performed by manufacturer. For any assistance intervention and original spare parts please contact the manufacturer at following address: GUANGZHOU LONGEST SCIENCE & TECHNOLOGY CO., LTD. Add: 5&6F, Building B4, No.11, Kaiyuan Avenue, Science City, Guangzhou Hi-tech Industrial Development Zone, 510530 Guangzhou, Guangdong Province, P.R. China Tel: +86 20 6635 3999 Fax: +86 20 6635 3920 Email: service@longest.cn Website: www.longest.cn EU Representatives Information Lotus Global Co., Ltd Company address: 1 Four Seasons Terrace West Drayton, Middlesex London, UB7 9GG, United Kingdom Tel: +44 20 75868010, 70961611 Fax: +44 20 79006187 To preserve product warranty, functionality and product safety we recommend using only original spare parts. FOR-MRRD0001-EN231 UM0.1 Warranty The Manufacturer warrants that the LGT-231 is free of defects in material and workmanship for the main unit. This warranty shall remain in effect for one year (12 months) from the date of original consumer purchase. If this Product fails to function during the one year warranty period due to a defect in material or workmanship, at the Manufacturer's Option, Manufacturer or the authorized dealer will repair this Product without charge. The users should fill out the Warranty Card as soon as the product is installed and send a copy to service@longest.cn to have the warranty be valid. Damages due to non-adherence to the User Manual or wear of parts are excluded from warranty. This Warranty Does Not Cover: Replacement parts or labor furnished by anyone other than the Manufacturer, the authorized dealer or a certified Company service technician. Defects or damage caused by labor furnished by someone other than Manufacturer, the authorized dealer or a certified Company service technician. Any malfunction or failure in the Product caused by product misuse, including, but not limited to, the failure to provide reasonable and necessary maintenance or any use that is inconsistent with the User Manual. FOR-MRRD0001-EN231 UM0.1
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