XFT-2003E Nerve and Muscle Stimulator (Trade Name: Upper Extremity 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.
Glossary EMG: Electromyography, it is an electro diagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles. sEMG: Surface EMG uses electrode like sensors to assesses muscle function by recording muscle activity from the surface above the muscle on the skin FES: Functional Electrical stimulation NMES: Neuromuscular electrical stimulation is the elicitation of muscle contraction using electric impulses. ETS: EMG triggered electrical 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 injury caused by inappropriate use 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.
2. Overviews 2.1 Product Introduction XFT-2003E 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. With multiple working modes and interactive gaming applications patients can actively participate in the rehabilitation process and receive treatment with greater enjoyment and customization.
OLED screen Multimedia interactive biofeedback rehab training (strength training, endurance training, coordination training) Functional electrical stimulation prescription management. Electrode isolation technology: EMG input and stimulation output through the same electrodes. Bluetooth 4.0 Low battery indication Treatment time limit Symmetric biphasic balanced wave Rechargeable lithium battery + USB Type-C port Auto off after 15 minutes of standby. Electrode loose indication 2.
3.1.1 Stimulator Front Back 3.1.2 Parts No. Parts Picture Remark 1 Power Adapter The Power Adapter and Charging Cable are and Charging used to charge the device. Cable 2 Electrode Cable The Electrode Cable is used to connect between (Optional) the device and the hydrogel electrodes. There are 3 size Electrode Cables for choice to Size 1 Size 2 Size 3 meet different patient’s need.
3 Hydrogel The hydrogel electrodes used for the device Electrodes have been cleared under 510(k) K132588. (Optional) While in use, they are connected to the device through the electrode cable, providing intramuscular stimulation to where they are placed on. The diameter of the hydrogel electrode is 50 mm, and the length of the lead wire is 12cm. 3.2 Operation Panel 3.2.
10-30mA, the intensity increases by 0.5mA increment; >30mA, the intensity increases by 0.1mA increment; User can feel the stimulation each time increasing the intensity. USB Type-C Port: The stimulator is equipped with a USB Type-C port, for device charging. Velcro Wristband: To be worn on the arm to fix the stimulator. 3.2.
5) Press the mode button to choose the mode (NMES mode, ETS mode, PAS mode, EMG mode, GAME mode) to start the treatment. 6) After, the treatment is complete, press the power button to turn off the device. 7) Remove the Stimulator 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.
Extensor Digitorum Muscle Extensor Carpi Ulnars Muscle 4.2 Use with electrode cable and hydrogel electrodes Warning: DO NOT use the hydrogel electrodes for multiple times. The hydrogel electrodes are only intended to be single used. 1) Plug the electrode cable into the electrode port of the Stimulator. 2) Connect the electrode cable to the hydrogel electrodes 3) Attached the electrodes to the desired body part i.e. shoulder, tricep, bicep or forearm flexors.
to red and yellow Muscle the wrist adduction wires Extensor Carpi Ulnars Muscle Extensor Digitorum Muscle 1. Connect Stimulator and Electrode 2. Connect Hydrogel Electrodes and 3. Place Hydrogel Electrodes Cable Electrode Cable 4. Press the power button 5. Press the mode button 7. Remove the Hydrogel Electrodes 14 / 44 6.
4.3 Charging the XFT-2003E Upper Extremity Rehab System 1) Take out the Power Adapter and the Charging Cable from the packaging. 2) Insert the USB end on the charging cable into the USB port of the charger. 3) Connect the Type-C end on the charging cable to the charging port on the Stimulator. 4) The battery icon will display on the screen of the Stimulator to indicate charging. 5) The battery icon will display on the screen of the device when it is fully charged 1. Take out the Power Adapter and the 2.
The Stimulator can be used with or without the APP. 5.1 Use without APP 5.1.1 Wear the Stimulator Please wear the device on the right location according to your need. Electrode Placement Motion (Stimulated Muscles) Extensor Digitorum Muscle Finger Extension and Wrist Extension Extensor Carpi Ulnars Muscle Wrist Extension,and make the wrist adduction Extensor Carpi Ulnars Muscle Extensor Digitorum Muscle 5.1.
5.1.3.2 ETS Press the Play/Pause button to start the treatment, and press “+” or “-” to adjust the intensity. The stimulation will be triggered when the user contracts the muscle and the EMG signal reaches the threshold. 5.1.3.3 PAS Press Play/Pause button to start the treatment, and press “+” or “-” to adjust the intensity. The stimulation will be triggered when user contracts the muscle. 5.1.3.4 EMG Press the Play/Pause button to start EMG signal test.
Install / Update Using your iPad, search for “SEMG-2003E” in App Store. Click "Get" in the below figure to start the installation. If it is already installed, click "Update", wait for the download to complete, and the installation or update is successful. APP operation environment: The New iPad, and subsequent iPad.
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. It neither accesses patient information data from other systems or software nor imports patient information data into other systems or software.
1.Select GAME mode 2.Run the SEMG-2003E APP on the 3.Register an Account iPad 4.Log in the account、Password、Confirm 5.Change Password Password Password 7.Log in on the iPad 6.Enter Password and Confirm 8.Search device 9.Connect device 10.APP home page 5.2.4 Create Patient Information 5.2.4.1 Click the patient icon to enter patient list page. 5.2.4.2 Click “+” icon to add patient record. 5.2.4.3 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 5.2.5 Mode Selection 5.2.5.1 NMES Mode 1) Click icon to enter the home page of NMES mode. 2) Click the prescription number to enter the prescription list page. 3) Select the desired prescription and a pop-up window will show. 4) Click “OK” to send the selected prescription to the Stimulation.
stimulation, we have provided 42 preset prescription and 8 customizable prescription. Parameters Preset prescriptions No.
29 3/2 5 0 0 5 400 30 5/8 22 2 1 30 400 31 8/15 20 3 1 60 400 32 6/10 11 2 2 40 400 33 3/2 5 0 0 5 400 34 5/8 22 2 1 30 400 35 8/15 20 3 1 60 300 36 6/10 11 2 2 40 400 37 3/2 5 0 0 5 400 38 5/8 17 2 1 35 400 39 8/15 16 3 1 60 100 40 6/10 11 2 2 40 400 41 3/2 5 0 0 5 200 42 5/10 17 2 1 40 200 8 customizable prescriptions Duration / interval, Time, Ramp up, Ramp down, Frequency and Pulse width can be set by the
4. Set the parameters 5. Click “OK” to send the parameters 7. Intensity value 8. EMG ranges 6. Press Start icon to start the treatment 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.
5.2.5.3 PAS Mode 1) Click icon to enter the home page of ETS/PAS mode. 2) Click PAS icon to switch to PAS mode. 3) Click Start icon to start the treatment. 4) Press “+” or “-” on the stimulator to adjust the intensity, and the intensity value will display on the iPad. 5) User can click icon of “LOW”, “MED”, or “HIG” to display different range of EMG. “LOW”: 0-300μV “MED”: 0-600μV “HIG”: 0-1000μV 1. Click ETS/PAS icon 2. Select PAS icon 4. Intensity value 5. EMG ranges 3.
“MED”: 0-600μV “HIG”: 0-1000μV 4) When the EMG test is complete, the result will show on the iPad. 1. Click EMG icon 2. Start EMG test 3. EMG ranges 4. Test result EMG Waveforms: X axis: time Y axis: EMG value (μV) 5.2.5.5 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.
Global Trip 1) Click the game icon of Global Trip, 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. Click the game icon of Global Trip 2.
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. Setting 3. Game page 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.
4) Click the “<” to return to the home page of GAME mode. 1. Click the game icon of Clever 2. Game page 3. Threshod setting Baboon 4. Return to home page 5.3 Other Functions 5.3.1 Treatment 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.
5.3.2 Treatment Intensity Limit The user can set up an intensity limit by using the application for example if the user sets up the maximum intensity to 25mA, then the maximum electrical output would be 25mA. The limit range is 0~60 mA. Note: If user doesn’t want the treatment time to be limited, then the limit value can be set as 0. 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.
Please adjust the electrodes and press Play/Pause button again to restart. 5.3.5 Auto Off The stimulator will auto off in 15 minutes if there is no operation. 6. Care and Maintenance 6.1 Maintenance for Stimulator Always handle the stimulator carefully Do not expose the stimulator to water, excessive heat or vibration. Keep it away from children. Use wet cloth with little neutral detergent or alcohol to clean stimulator’s surface. Avoid dropping the stimulator.
6.6 Product Service Life The service life of the XFT-2003E is 5 years. At the end of its life expectancy or the device ceases to continue working please dispose of it in accordance with the local and national regulation. 6.7 Battery Safety Please charge this device only with the original charger and do not use the device while charging. The XFT-2003E Upper Extremity Rehab System has a rechargeable battery that can only be replaced by an XFT Battery cycle times 500 times.
Differential mode input impedance >5MΩ Common mode rejection ratio >100dB Power frequency notch 50Hz/100μV (Peak-to-valley); after attenuation, ≤5μV (Peak-to-valley) Indication accuracy ±10% / ±2μV ; whichever is greater Feedback threshold accuracy ±10% central frequency Type of stimulation output constant current Electrical stimulation intensity 0-60mA (Peak value±10% /±2mA, whichever is greater, 500 Ω) 2.
Current 0.3A 2. Output Voltage DC 5V Current 1.2A Note 1: The metal electrodes and the hydrogel electrodes cannot be used at the same time. The 2 types of electrodes perform the same function when they are in use separately. Note 2: Do not use the device when it is in charging. Wireless Technology Description Type of wireless technology Bluetooth V4.
9. Troubleshooting Error Description of Solution Error Electrode loose 1. if used with metal electrodes, wet with skin with water to improve the electrical conductivity 2. if used with hydrogel electrodes, check the connection between the Electrode Cable and device, or between the Electrode Cable and the hydrogel electrodes; or replace the hydrogel electrodes. / Stimulator cannot 1. Confirm that the power button is in good contact.
-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 iOS.
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 user has the responsibility to warn user or any others to comply with this standard. Caution: The manufacturer will not be responsible for any unauthorized actions that cause interference.
Surge IEC 61000-4-5 Voltage dips IEC 61000-4-11 ±0.5kV, ±1kV ±0.5kV, ±1kV 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; 0.5 At 0°, 45°, 90°, 135°, cycle 180°, 225°, 270° and At 0°, 45°, 90°, 315° 135°, 180°, 225°, Mains power quality should be typical commercial or hospital environment. UPS power is recommended if this device needs to be used continuously.
cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the device). Where “P” is the maximum output power rating of the transmitter Radiated RF IEC 61000-4-3 10 V/m 80 MHz to 2.7 GHz in watts according to transmitter manufacturer and “d” is the 10 V/m recommended separation distance in meters. Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey (b), should be less than the compliance level in each frequency range (c).
1970 GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS 2450 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 0.3 9 5240 5500 5785 NOTE: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m distance is permitted by IEC 61000-4-3.
12.After-Sale Service 12.1 The original XFT-2003E 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.
Product Name: Nerve and Muscle Stimulator Trade Name: Upper Extremity Rehab System Model: XFT-2003E Shenzhen XFT Medical Limited Room203, 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 605 Sherwood Forest Place, Cary, North Carolina Cary , NC 27519 Phone: 919 4751044 Ext Date:2020/10/21 No.
