XFT Medical XFT-2003E User Manual
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XFT Medical XFT-2003E User Manual

Nerve and muscle stimulator
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User Manual
Nerve and Muscle Stimulator
(Trade Name: Hand Rehab System) [XFT-2003E]
MNL-0022
Caution: Thanks for choosing our product. Please read this manual before use and keep it carefully.

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Summary of Contents for XFT Medical XFT-2003E

  • Page 1 User Manual Nerve and Muscle Stimulator (Trade Name: Hand Rehab System) [XFT-2003E] MNL-0022 Caution: Thanks for choosing our product. Please read this manual before use and keep it carefully.

  • Page 2: Table Of Contents

    Content Glossary ........................2 1. For Your Health and Safety ..................3 2. Overviews ........................6 3. Product Illustration ...................... 8 4. Setup Instruction ...................... 12 5. Operation Instruction ....................14 6. Care and Maintenance ..................... 38 7. Product Configuration ....................39 8.

  • Page 3: Glossary

    OMNIHI5 USER MANUAL 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.

  • Page 4: For Your Health And Safety

    OMNIHI5 USER MANUAL 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 and are categorized into sections of: Contraindications, Warning and Precautions. •...
  • Page 5 Warning • Do not use the XFT-2003E while receiving any MRI scan. • Do not use the XFT-2003E while sleeping, bathing or operating a vehicle. • The long-term effects of chronic electrical stimulation are unknown. • Stimulation should not be applied over the carotid sinus nerves, particularly in patients with a known sensitivity to the carotid sinus reflex.
  • Page 6 OMNIHI5 USER MANUAL Precautions • Do not use near (within one meter) of short-wave technology or a microwave. • Patients with heart disease, severe hypertension and skin disorder are forbidden to use this product. • Patient with epilepsy is forbidden to use this product. •...

  • Page 7: Overviews

    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 training modes and interactive gaming applications patients can actively participate in the rehabilitation process and receive treatment with greater enjoyment and customization.
  • Page 8 OMNIHI5 USER MANUAL 2.3 Indications for Use Functional Electrical Stimulation (FES) Improvement of hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury. Neuromuscular Electrical Stimulation (NMES) Increase or maintain hand range of motion Reduce muscle spasms Retard muscle atrophy...

  • Page 9: Product Illustration

    OMNIHI5 USER MANUAL 3. Product Illustration 3.1 Components The XFT-2003E consists of the Stimulator, Power Adapter, Charging Cable, Electrode Cables (optional), and Hydrogel Electrodes (optional). 3.1.1 Stimulator 3.1.2 Parts Parts Picture Description Power Adapter The Power Adapter and Charging Cable are used to charge the device.
  • Page 10 OMNIHI5 USER MANUAL 3.2 Operation Panel 3.2.1 Operation button instruction Upper Selection Button OLED Screen Intensity Button “+” Play/Pause Button Mode Button Down Selection Button Intensity Button “-” Electrical Power Button Stimulation Output Port USB Port Wristband MNL-0022...
  • Page 11 OMNIHI5 USER MANUAL Metal electrodes This device has 7 buttons (1 power button and 6 function buttons), and 1 USB Type-C port. • Power Button: Press and hold for 1 second to turn on / turn off the stimulator. • Mode Button: Switch and select among NMES, ETS, PAS, EMG and GAME mode.
  • Page 12 OMNIHI5 USER MANUAL 3.3.2 Screen Icons Icon Function Explanation It will flash once per second when the battery is lower than 10%, and the stimulator will stop and auto off in 5 minutes. Battery level The stimulator will auto off in 5 seconds when the battery is lower than 2%.

  • Page 13: Setup Instruction

    OMNIHI5 USER MANUAL 4. Setup Instruction 4.1 Use with metal electrodes Peel off the transparent film from the metal electrodes; Add some water to the area of skin; Wear the Stimulator on the arm and make sure that the metal electrodes attach to the extensor muscles wrist extensors.
  • Page 14 OMNIHI5 USER MANUAL 4.2 Charging the Stimulator Take out the Power Adapter and the Charging Cable from the packaging. Insert the USB end on the charging cable into the USB port of the charger. Connect the magnetic end of the charging cable to the charging port of the Stimulator.

  • Page 15: Operation Instruction

    OMNIHI5 USER MANUAL 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. • After cleaning, wipe the electrode with a sponge or a soft cloth dampened with disinfectant (do not rub too much disinfectant liquid on a sponge or a soft cloth to avoid splashing into the inside of the device causing malfunction or danger).
  • Page 16 OMNIHI5 USER MANUAL 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.
  • Page 17 OMNIHI5 USER MANUAL 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.
  • Page 18 OMNIHI5 USER MANUAL 5.2 Uses with the app 5.2.1 Download or update app 1) Connect to WIFI Check in “Settings” to see if your iPad is connected to a Wi-Fi network. If not connected, select the WiFi that can be connected and enter the password to connect. MNL-0022...
  • Page 19 (The APP software Rev. 1) provided by the manufacturer. The device has two parts, the XFT-2003E and APP software, which is installed on iPad. User interface is located on APP software, including parameters setting and display of images.
  • Page 20 OMNIHI5 USER MANUAL 5.2.2 Wearing the Stimulator Wear the device at the correct location (See 5.1.1 Wear the Stimulator) according to your need and corresponding motor response. Add ample amounts of water to the area of skin that will be in contact with the electrodes. MNL-0022...
  • Page 21 OMNIHI5 USER MANUAL 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”...
  • Page 22 OMNIHI5 USER MANUAL 3. Register an Account 4. Log in the account, Confirm Password 5. Change Password 6. Enter Password and Confirm Password 7. Log in on the iPad 8. Search device MNL-0022...
  • Page 23 OMNIHI5 USER MANUAL 9. Connect device 10. APP home page 5.2.5 Create Patient Information Click the patient icon to enter patient list page. Click “+” icon to add patient record. Edit the patient information and Save. 2. Click “+” icon to add patient 1.
  • Page 24 OMNIHI5 USER MANUAL 5.2.6 Mode Selection 5.2.6.1 NMES Mode Click icon to enter the home page of NMES mode. Click the prescription number to enter the prescription list page. Select the desired prescription and a pop-up window will show. Click “OK” to send the selected prescription to the Stimulation. Another pop-up window will display to indicate that the prescription is sent successfully;...
  • Page 25 OMNIHI5 USER MANUAL 5. Send successfully 6. Press Start icon to start the treatment Prescription Selection: The user can choose different programs based on his/her needs. According to the international standard for electrical stimulation, we have provided 42 preset programs and 8 customizable programs.
  • Page 26 OMNIHI5 USER MANUAL 3. Click the setting icon 4. Set the parameters 5. Click “OK” to send the parameters 6. Press Start icon to start the treatment 7. Intensity value 8. EMG ranges MNL-0022...
  • Page 27 OMNIHI5 USER MANUAL Parameter Setting: • Threshold: 2-1000uV; • Pulse width: 50*450 us, 10ps increment, • Frequency: 2-100Hz, 1 Hz increment, • Ramp up: 0-5s, 0.1s increment, • Ramp down: 0-5s, 0.1s increment, • Duration: 1-10s, 0.1s increment, • Delay: 0-5s, 0.1s increment, 3 different ranges of EMG: •...
  • Page 28 OMNIHI5 USER MANUAL 5.2.6.3 PAS Mode Click icon to enter the home page of ETS/PAS mode. Click PAS icon to switch to PAS mode. Click Start icon to start the treatment. Press “+” or “-” on the stimulator to adjust the intensity, and the intensity value will display on the iPad.
  • Page 29 OMNIHI5 USER MANUAL 3 different ranges of EMG: • “LOW”: 0-300uV • “MED”: 0-600uV • “HIGH”: O-1000uV 5.2.6.4 EMG Mode Click icon to enter the home page of EMG mode. Click Start icon to start EMG test and the whole process will last 15 seconds. User can click icon of “LOW”, “MED”, or “HlGH”...
  • Page 30 OMNIHI5 USER MANUAL The screen can show 3 different ranges of EMG: • “LOW”: 0-300uV • “MED”: 0-600uV • “HIGH”: 0-1000uV 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.
  • Page 31 OMNIHI5 USER MANUAL Global Trip Click the game icon of Global Trip, and it will enter the game page. 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 to start the game.
  • Page 32 OMNIHI5 USER MANUAL Zombie Avenger Click the game icon of Zombie Avenger, and it will enter the game page. 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.
  • Page 33 OMNIHI5 USER MANUAL Funnies Click the game icon of Funnies, and it will enter the game page. 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.
  • Page 34 OMNIHI5 USER MANUAL Dancing Melody Click the game icon of Dancing Melody, and it will enter the game page. Click the setting icon, a pop-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.
  • Page 35 OMNIHI5 USER MANUAL Jigsaw Show Click the game icon of Jigsaw Show, and it will enter the game page. Click the icon of “Choose Picture” and select a picture from the iPad album. 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.
  • Page 36 OMNIHI5 USER MANUAL Clever Baboon Click the game icon of Clever Baboon, and it will enter the game page. 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.
  • Page 37 OMNIHI5 USER MANUAL 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.
  • Page 38 OMNIHI5 USER MANUAL 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. 5.3.5 Auto Off The stimulator will auto off in 15 minutes if there is no operation.

  • Page 39: Care And Maintenance

    OMNIHI5 USER MANUAL 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. •...

  • Page 40: Product Configuration

    OMNIHI5 USER MANUAL 6.5 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.

  • Page 41: Product Specifications

    OMNIHI5 USER MANUAL 8. Product Specifications 8.1 Stimulator Specifications Stimulator Specifications Dimensions 140*58*27mm Weight 120g Service life 5 Years Working Condition: Temperature: 5°C-40 °C (41°F- 104°F) Relative humidity: ≤80% (non-condensing) Atmospheric pressure: 86kPa-106kPa Environmental Ranges Transport Condition: Temperature: -20°C-55°C (-4°F- 131°F) Relative humidity: ≤93% (non-condensing) Atmospheric pressure: 70kPa-106kPa 1.
  • Page 42 Signal-to-noise Ratio -88dBm The wireless QoS need XFT-2003E Nerve and Muscle Stimulator was designed and tested to have a response rate of 10-100ms latency depending on system configuration. Wireless Interference The XFT-2003E Nerve and Muscle Stimulator was designed and tested and as...
  • Page 43 OMNIHI5 USER MANUAL Caution: If the performance of the XFT-2003E Nerve and Muscle Stimulator is affected by other equipment. The user should turn the XFT-2003E Nerve and Muscle Stimulator off and move away from the interfering equipment. Treatment Programs Parameter...

  • Page 44: Troubleshooting

    OMNIHI5 USER MANUAL 9. Troubleshooting Error Description of Error Solution 1. Wet the skin with water to improve the electrical conductivity. Electrode loose 2. Check the contact between the skin and the electrodes, and adjust the place of the electrodes. 1.

  • Page 45: Frequently Asked Questions

    OMNIHI5 USER MANUAL 10. Frequently Asked Questions 10.1 What should I do if the electrical stimulation intensity is weak? Adjust the placement position. Adjust the electrical stimulation intensity through the stimulator or app software. Check the battery and charge if low. Wet the skin to increase the electrical conductivity between the electrode and the skin.
  • Page 46 OMNIHI5 USER MANUAL 10.5 How to restore the factory default settings? Warning: Factory reset will restore your device to the state where it was made out in the factory. This implies that your passwords, accounts and other personal data that you may have stored on the device App will be wiped out clean.

  • Page 47: Electromagnetic Compatibility (Emc)

    Table 1 Guidance and manufacture’s declaration -electromagnetic emission The XFT-2003E Nerve and Muscle Stimulator is intended for use in the electromagnetic environment specified below. The user should comply with specifications ensuring the device is only used in an appropriate environment.
  • Page 48 Table 2 Guidance and manufacture’s declaration - electromagnetic emission The XFT-2003E Nerve and Muscle Stimulator is intended for use in the electromagnetic environment specified below. The user should comply with specifications ensuring the device is only used in an appropriate environment.
  • Page 49 Table 3 Guidance and manufactured declaration - electromagnetic immunity The XFT-2003E Nerve and Muscle Stimulator is intended for use in the electromagnetic environment specified below. The user should comply with specifications ensuring the device is only used in an appropriate environment.
  • Page 50 OMNIHI5 USER MANUAL a) The ISM (industrial, scientific and medical) bands between 0.15 MHz and 80 MHZ are6.765 MHz to6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHZ to 40.70 MHz. The amateur radio bands between 0.15 MHz and 80 MHz are 1.8MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz, 5.3 MHz to 5.4 MHz, 7 MHz to 7.3 MHz, 10.1 MHz to 10.15 MHz 14 MHz to 14.2 MHz, 18.07 MHz to 18.17 MHz, 21.0 MHz to 21.4 MHZ, 24.89 MHz to 24.99 MHz, 28.0 MHz to 29.7 MHz and 50.0 MHz to 54.0 MHz.
  • Page 51 OMNIHI5 USER MANUAL Table 4 Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test IMMUNITY frequency Band Maximum Distance Test Level (MHz) (MHz) Service Modulation power (W) (V/m) Pulse 380-390 TETRA 400 modulation 18 Hz FM c) ±5kHz GMRS 460, 430-470 deviation 1...
  • Page 52 OMNIHI5 USER MANUAL Table 5 Recommended separation distances between portable and mobile RF (Radio Frequency) communications equipment and the XFT-2003E Nerve and Muscle Stimulator The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent...

  • Page 53: Use Specification

    Item Description Product Name Nerve and Muscle Stimulator Product model XFT-2003E Intended use/indications for use Functional Electrical Stimulation (FES). Improvement of hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury.

  • Page 54: After-Sale Service

    OMNIHI5 USER MANUAL 13. After-Sale Service 13.1 The original XFT-2003E product you have purchased is covered by a 24-month warranty that begins on the date of purchase. 13.2 The distributor will not provide free repair for the malfunctions caused by the following behaviors: •...
  • Page 55 Model No.: _______________________________ Purchase Date: ___________________________ Product Serial No.: _________________________ Buyer’s Information: ______________________________________________________________________ Distributor’s Information: __________________________________________________________________ Manufacturer: Shenzhen XFT Medical Limited Add: Room 203, Building 1, Biomedicine Innovations Industrial Park, #14 Jinhui Road, Pingshan New District, Shenzhen, China Tel: 86-755-29888818 Web: www.xft-china.com Mail: xft@xft.cn...
  • Page 56 OMNIHI5 USER MANUAL Product Name: Nerve and Muscle Stimulator (Trade Name: Hand Rehab System) Model No.: XFT-2003E 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...

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