XFT-2003EA Nerve and Muscle Stimulator (trade name: Hand Rehab System) User Manual Caution: This is a class II FDA cleared medical device. Federal regulations restricts the order or delivery of this medical device to certified clinicians licensed by the law of the State in which he/she practices to use as indicated within their scope of practice. Order and delivery of this medical device for patient home use must be accompanied by a physician prescription. Thanks for choosing our product.
Content 1. For Your Health and Safety........................................................................................................................ 4 2. Overviews...................................................................................................................................................7 3. Product Illustration.....................................................................................................................................8 4. Setup Instruction.....
Glossary EMG: Electromyography, it is an electro diagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles. EMG: Surface EMG uses electrode like sensors to assesses muscle function by recording muscle activity from the surface above the muscle on the skin NMES: Neuromuscular electrical stimulation is the elicitation of muscle contraction using electric impulses. ETS: EMG triggered electrical stimulation. PAS: Power assistant stimulation.
1. For Your Health and Safety To avoid any danger or injury caused by inappropriate use, please read this manual carefully. Safety precautions include danger or injuries caused by inappropriate use and are categorized into sections of: danger, warning and attention. Please read this manual carefully.
Humidity limitation Atmospheric pressure limitation Contraindications Do not use the device where a cancerous lesion in present or suspected. Do not use the device if you have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device. Use of the device in conjunction with any of the above may cause electric shock, burns, electrical interference, or death.
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.
contractions may put the user at undue risk of injury. Patients who use the device at home need to be trained by a doctor and follow the treatment plan set by their doctor. 2. Overviews 1) Product Introduction XFT-2003EA detects and monitors the EMG muscle activity signal of a patient and delivers an electrical stimulation pulses according to EMG signal strength to stimulate the patient in order to achieve a muscle contraction.
EMG Triggered Stimulation Power Assistant Stimulation Functional Electrical Stimulation OLED screen Multimedia interactive biofeedback rehab training (muscle training, endurance training, coordination training) Functional electrical stimulation prescription management. Electrode isolation technology: EMG input and stimulation output through the same electrode Bluetooth 4.
3.1.1 Stimulator 3.1.2 Parts No. 1 2 Parts Picture Power The Power Adapter and Charging Cable are Adapter used to charge the device. Charging Cable 3.2 Operation Panel 3.2.
Magnetic charging port Wristband Metal electrodes This device has 5 buttons and 1 charging port. Power Button: Press and hold 1 for second to turn on / turn off the stimulator. Mode Button: a) Switch among the Modes. b) Press and hold the mode button for 5 seconds to switch the language. The product serial number and software version will display at the same time. c) When the device is powered off press and hole the power button and mode button at the same time.
Metal electrodes: To deliver the electrical stimulation 3.2.2 Screen Icons Icon Function Explanation Battery level It will flash once per second when the battery is lower than 10%, and the stimulator will stop and auto off in 5 minutes. The stimulator will auto off in 5 seconds when the battery is lower than 2%. Charging The scrolling battery icon indicates that the device is charging, and when the battery icon shows a full battery, the device is fully charged.
the treatment. 6) After, the treatment is complete, press the power button to turn off the device. 7) Take off the device from the arm. 8) Clean the metal electrode and the device with a soft cloth, and then store it in the portable case. 1.Peel off the transparent film 2. Add some water to the area of skin 3.Wear the Stimulator 4.Press the power button 5.Press the mode Button 6.Press the power button 7.Remove the Stimulator 8.Clean the metal electrodes 4.
1. Take out the Power Adapter and the 2. Connect the Power Adapter and the 3. Connect the Stimulator Cable and the Charging Cable Charging Cable Stimulator 4. Battery icon on the Stimulator 5. Fully charged 5. Operation Instruction Use a sponge or a soft cloth to remove dust and dirt from the electrode surface before use, please keep the electrode clean.
Extensor Carpi Ulnars Muscle Extensor Digitorum Muscle 5.1.2 Power on Before using the device, please use water to clean and wet the skin area where electrodes will be attached. Hold the power button for 1 second and you will see the following interface. It will go to the default NMES mode in 3 seconds. Press the mode button to switch and select among NMES, ETS, PAS, EMG and GAME mode. 5.1.3 Mode Selection 5.1.3.
5.1.3.4 EMG Press the Play/Pause button to start EMG signal test. The stimulator will test the EMG signal in 3 cycles of 3 seconds relax and 6 seconds flex, and then comes the average value. 5.1.3.5 GAME GAME mode is not available if the device is not connected with APP. 5.2 Use with the APP 5.2.1Download or update APP 1) Connect to WiFi Check in “Settings” to see if your iPad is connected to a WiFi network. If not connected, select the WiFi that can be connected and enter the password to connect.
APP operation environment: The New iPad, and subsequent iPad. Hardware Requirement: Software Requirement: iOS 9.0 or later Requirement of security software: no Requirement of Internet: BLE Network requirements when using the APP: The APP will not be connected to the Internet during the use of the APP, and there is no need to connect to the Internet. Data and Device Interface: The data in the APP is limited to internal storage access in the APP.
water to the area of skin that will be in contact with the electrodes. 5.2.3 Power on Hold the power button for 1 second and you will see the following interface: The display will go to the default NMES mode in 3 seconds. Press the mode button to switch and select among NMES, ETS, PAS, EMG, GAME mode. 5.2.4 Connect with APP Press “Mode” button to select the “GAME” mode on the stimulator. Run SEMG-2003E APP on the iPad. Account registration is required for the first use.
10.APP home page 5.2.5 Create Patient Information 1) Click the patient icon to enter patient list page. 2) Click “+” icon to add patient record. 3) Edit the patient information and Save. 1. Click the patient icon to enter patient 2. Click “+” icon to add patient record 3. Edit the patient information and Save list page 5.2.6 Mode Selection 5.2.6.1 NMES Mode 1) Click icon to enter the home page of NMES mode. 2) Click the prescription number to enter the prescription list page.
home page of NMES mode. 6) Click “Start” icon to start the treatment. 7) Press “+” or “-” on the stimulator to adjust the intensity. 1. Click NMES icon 2. Click the Prescription 3. Select a prescription 4. Send the selected prescription 5. Send successfully 6. Press Start icon to start the treatment Prescription Selection: The user can choose different prescription based on his/her needs.
11 6/15 11 2 1 60 200 12 6/8 13 2 2 40 200 13 3/2 5 0 0 5 300 14 6/6 25 2 1 25 150 15 8/12 25 2 1 35 100 16 6/5 21 2 2 40 50 17 3/2 5 0 0 5 300 18 6/6 25 2 1 35 200 19 8/12 25 2 1 60 50 20 6/5 21 2 2 40 100 21 3/2 5 0 0 5 300 22 6/6 25 2 1 25 300 23 8/12 25 2 1 35 300 24 7/10 17 5 0 40 150 25 5/4 10 2 1 5 300 26 6/15 11 2 1 60 50 27 6/12 17 2 2 40 100 28 6/4 19 2 2 40 200 29 3/2 5
42 5/10 8 customizable prescriptions 17 2 1 40 200 Duration / interval, Time, Ramp up, Ramp down, Frequency and Pulse width can be set by the user. 5.2.6.2 ETS Mode icon to enter the home page of ETS/PAS mode. 1) Click 2) Click ETS icon to switch to ETS mode. 3) Click Setting icon to pop up the window of parameters. 4) Adjust the parameters by sliding the finger on the screen for each parameter. 5) After all the parameters are set, click “OK” to return to the home page of ETS mode.
Parameter Setting: Parameters Range Threshold It can be adjusted start from 2μV to 1000 μV with 1uV increment. The default is 10μV. Pulse width It can be adjusted start from 50μs to 450μs with 10μs increment. Frequency It can be adjusted start from 2Hz to 100Hz with 1Hz increment. Ramp up It can be adjusted start from 0 s to 5s with 0.1s increment. Ramp down It can be adjusted start from 0 s to 5s with 0.1s increment. Duration time It can be adjusted start from 1 s to 10s with 0.1s increment.
4. Intensity value 5. EMG ranges Parameter Setting: Under PAS mode, the stimulator outputs NMES electrical stimulation at regular pulse width(200μs), frequency(18Hz). The intensity of electrical stimulation is controlled by the patient’s spontaneous EMG intensity. 5.2.6.4 EMG Mode 1) Click icon to enter the home page of EMG mode. 2) Click Start icon to start EMG test, and the whole process will last 15 seconds. 3) User can click icon of “LOW”, “MED”, or “HIG” to display different range of EMG.
EMG Waveforms: X axis: time Y axis: EMG value (μV) 5.2.6.5 GAME Mode Six games are now available for muscle strength training, endurance training and coordination training. Patients control the games by contracting certain muscles while enjoying the fun of a rehabilitation game mode format. 1) Click icon to enter the home page of GAME mode. 2) Six games are now available for muscle strength training, endurance training and coordination training.
Zombie Avenger 1) Click the game icon of Zombie Avenger, and it will enter the game page. 2) Click the setting icon, a pup-up window will show the threshold of the EMG. Set the appropriate threshold by sliding the finger on the screen. Press Start icon the start the game. 3) Contract and relax the muscles to control the game. Once the EMG value exceeds the threshold, the game character will be triggered to move on. 4) Click the “<” to return to the home page of GAME mode. 1.
1. Click the game icon of Funnies 2. Game page 3. Threshod setting 4. Return to home page Dancing Melody 1) Click the game icon of Dancing Melody, and it will enter the game page. 2) Click the setting icon, a pup-up window will show the threshold of the EMG. Set the appropriate threshold by sliding the finger on the screen. Press Start icon the start the game. 3) Contract and relax the muscles to control the game. Once the EMG value exceeds the threshold, the game character will be triggered to move on.
Jigsaw Show 1) Click the game icon of Jigsaw Show, and it will enter the game page. 2) Click the icon of “Choose Picture” and select a picture from the iPad album. 3) Click the setting icon, a pup-up window will show the threshold of the EMG. Set the appropriate threshold by sliding the finger on the screen. Press Start icon the start the game. 4) Contract and relax the muscles to control the game. Once the EMG value exceeds the threshold, the game character will be triggered to move on.
1. Click the game icon of Clever 2. Game page 3. Threshod setting Baboon 4. Return to home page 5.3 Other Functions 5.3.1Treatment Time Limit The user can limit the treatment time in the application and the stimulator will stop and once the time is up. The stimulator will be unavailable until another treatment time limit is set. Note: If user doesn’t want the treatment time to be limited, then the limit value can be set as 0. 5.3.
5.3.3 Low Battery Indication It will flash once per second when the battery is lower than 10%, and the stimulator will stop and auto off in 5 minutes. The simulator will auto off in 5 seconds when the battery is lower than 2%. 5.3.4 Loose Electrodes Indication The electrodes loose indicator will display and the stimulator will stop when the electrodes and the skin have poor contact. Please adjust the electrodes and press Play/Pause button again to restart. 5.3.
Use 75% ethyl alcohol to clean the electrode surface and use clean towel to wipe it. Do not wash with detergent or hot water. Electrodes should be covered with the film when not in use. Keep it clean and restore it carefully. 6.3 Skin Care Please check your skin condition before and after use. Slight redness is normal and it indicates the blood circulation is faster in this area. Always add ample amounts of water to the area of skin that will be in contact with the electrodes. 6.
Weight 145g Service life 5 Years Working Condition: Temperature: 5℃-40 ℃ Relative humidity: ≤80% (non-condensing) Atmospheric pressure: 86kPa-106kPa Environmental Ranges Transport Condition: Temperature: -20℃-55℃ Relative humidity: ≤93% (non-condensing) Atmospheric pressure: 70kPa-106kPa 1.
Size 37.94*36.75mm 2 pcs 35.77*9.94mm 1pc Power Adapter Specifications 1. Input Voltage AC100-240V Frequency 50-60Hz Current 0.3A 2. Output Voltage DC 5V Current 2A Note: Do not use the device when it is in charging. Wireless Technology Description Type of wireless technology Bluetooth V4.
Electrode loose 1. Wet the skin with water to improve the electrical conductivity. 2. Check the contact between the skin and the electrodes, and adjust the place of the electrodes. / Stimulator cannot 1. Confirm that the power button is in good contact. Release the power on power button, gently wipe the button and finger with water, then press the power button again to turn it on; 2. Confirm if the battery is low. Charge the Stimulator; try again after the stimulator is fully charged..
-Power off the device, long press the power button and mode button at the same time for about 8 seconds, until the OLED screen is light up, then the factory rest is successful. 10.6 How to backup data? -No need to backup your personnel data, the device will backup your data and system setting automatically. 10.7 How to keeping my device safe from Cyber Threats? -Only buy smartphones form vendors who authorized, ensure your mobile phone operation system is officially released by android or iOS.
Caution: it is customer’s responsibility to assure that this equipment and vicinity equipment comply with the contents of IEC 60601-1-2 4th Edition. Caution: do not use any device that might send out RF signals, including cell phone, radio transceiver and radio control products, which might cause operation parameters beyond the standards. Please shutdown these devices when you are near the equipment. The clinician has the responsibility to warn user or any others to comply with this rule.
line-to-line line-to-line ±0.5kV, ±1kV, ±2kV line-to-ground 0 % UT; 0.5 cycle ±0.5kV, ±1kV, ±2kV line-to-ground 0 % UT; 0.
Radiated RF IEC 61000-4-3 80 MHz to 2.7 GHz peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the device). 10 V/m Where “P” is the maximum output power rating of the transmitter in watts according to transmitter manufacturer and “d” is the recommended separation distance in meters.
780 810 800-960 GSM 800/900, TETRA 800, iDEN 820, CDMA 85, LTE Band 5 Pulse modulation b) 18 Hz 2 0.3 28 1700-1990 GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS Pulse modulation b) 217 Hz 2 0.3 28 2400-2570 Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 Pulse Modulation b) 217 Hz 2 0.3 28 5100-5800 WLAN 802.11 a/n Pulse modulation b) 217 Hz 0.2 0.
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 1.2 1.2 2.3 10 3.79 3.79 7.27 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance “d” in meters can be estimated using the equation applicable to the frequency of transmitter, where “P” is the maximum output power rating of the transmitter in watts according to the transmitter manufacturer.
12.After-Sale Service 12.1 The original XFT-2003EA product you have purchased is covered by a 24-month warranty that begins on the date of purchase. 12.2 The distributor will not provide free repair for the malfunctions caused by the following behaviors: Dismantle or modify the product without authorization. Accidentally blow or drop the product during use or transportation. Lack of reasonable maintenance. Not using the device in according to instruction. Unauthorized repair 12.
Warranty Card Be sure to call for authorization before returning any equipment. You must receive a return authorization number and specific instructions on the process. Remove or copy this form and include it with the unit(s). Include copy of original invoice and return the device to the address in the Returning Equipment section. Name Address Phone No.
Product Name: Nerve and Muscle Stimulator Trade Name: Upper Extremity Rehab System Model: XFT-2003EA Shenzhen XFT Medical Limited Room 203, Building 1, Biomedicine Innovations Industrial Park, #14 Jinhui Road, Pingshan New District, Shenzhen, China Tel.：86-755-29888818 Fax.：86-755-28312625 Website：http://www.xft-china.com E-mail：xft@xft.cn US Agent Yang Lingyun 605 Sherwood Forest Place, Cary, North Carolina Cary, NC 27519 Phone: 919 4751044 Ext Date: 2020/10/21 No.
