XFT Medical WalkAide II User Manual
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XFT Medical WalkAide II User Manual

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Technology Upgrades
User Manual
Caution:
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Please read the instruction manual carefully and thoroughly before operating this device.
•
Also please keep it available for future reference.
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Summary of Contents for XFT Medical WalkAide II

  • Page 1 Technology Upgrades Our Life User Manual Caution: • Please read the instruction manual carefully and thoroughly before operating this device. • Also please keep it available for future reference.

  • Page 3: Table Of Contents

    WALKAIDE II USER MANUAL Content 1. For Your Health and Safety ..................2 2. Overviews ........................4 3. Product Illustration ...................... 5 4. General Operation Instruction .................. 10 5. Attentions ......................... 25 6. Care and Maintenance ..................... 26 7. FAQ & Troubleshooting .................... 28 8.

  • Page 4: For Your Health And Safety

    WALKAIDE II USER MANUAL 1. For Your Health and Safety • To avoid any danger or loss caused by inappropriate use, please read this manual carefully. • The hazards and losses caused by improper use are stated in the safety precaution section, and divided into “Contraindications”...
  • Page 5 WALKAIDE II USER MANUAL Contraindications • Do not use with electronic monitoring equipment, NMR-imaging, pacemaker, defibrillator or high-frequency medical device. • Do not use near short-wave, microwave. (such as 1m) • Patients with severe heart disease, severe hypertension and skin disorder are forbidden to use this product.

  • Page 6: Overviews

    WALKAIDE II USER MANUAL 2. Overviews 2.1 Indication for Use The XFT-2001E Foot Drop System is a wearable functional electrical stimulation device for rehabilitation, with an associated smart phone operating system. Intended Use XFT-2001E Foot Drop System is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons.

  • Page 7: Product Illustration

    WALKAIDE II USER MANUAL 3. Product Illustration 3.1 Product Parts XFT-2001E consists of the Stimulator, Power Adapter, charging cable, and app software (optional). 3.1.1 Stimulator Stimulator 3.1.2 Parts Parts Picture Description Power Adapter The Power Adapter and Charging Cable are used to charge the device.
  • Page 8 WALKAIDE II USER MANUAL 3.2 Operation Panel 3.2.1 Operation Buttons The stimulator contains 3 buttons (1 Power/Mode Button, 2 Intensity Buttons), and 1 OLEO display. Power/Mode Button: Press and hold this button for 2 seconds to turn the stimulator on, and the stimulator display shows “XFT” LOGO for 2 seconds; tap this button to switch between Gait mode and Training mode.
  • Page 9 WALKAIDE II USER MANUAL 3.3.2 Indicators Power-on indication Press and hold the Power/Mode Button for 2 seconds to turn the stimulator on, and the stimulator display shows “XFT” LOGO for 2 seconds. Tap this button to switch between Gait mode and Training mode.
  • Page 10 WALKAIDE II USER MANUAL Electrode Loose Indication When the electrodes are in poor contact with skin, the screen will flash the warning icon and “Drop” alternately. The stimulator will have 3 beeps and stop automatically. Please take off the stimulator, wet the skin and wear the stimulator again, and then press the intensity button to continue the mode.
  • Page 11 WALKAIDE II USER MANUAL 3.3 APP Software Description Operation Buttons Software Name: Foot Drop Rehab Operational Environment: Hardware Requirements: • iPhone 5s and subsequent release models of the iPhone. • Mobile phone with Android 6.0 and later. Software Environment: iOS: •...

  • Page 12: General Operation Instruction

    WALKAIDE II USER MANUAL 4. General Operation Instruction 4.1 How to clean the device? • Use a sponge or a soft cloth to remove dust and dirt from the electrode surface before use, please keep the electrodes 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 13 WALKAIDE II USER MANUAL 4.3 Use without App 4.3.1 Wear the Stimulator • Use a wet towel to clean the skin of the leg. • Sit on a chair, bend and relax the leg. • Place the stimulator in the correct position under the knee.
  • Page 14 WALKAIDE II USER MANUAL 4.3.2 Power on and Operate Press and hold the Power/Mode Button for 2 seconds to turn the stimulator on, and the stimulator display shows “XFT” LOGO for 2 seconds. Tap this button to switch between Gait mode and Training mode.
  • Page 15 WALKAIDE II USER MANUAL 4.4 Use with App 4.4.1 Install App Procedure Operation Description Go to App Store or Google Play. Search “Foot Drop Step 1 Rehab” to find the app. Install on your mobile phone. Step 2 Run the app on your mobile phone and create a user ID for the first time.
  • Page 16 WALKAIDE II USER MANUAL 4.4.3 Power On and Operate Power On Press and hold the Power/Mode Button for 2 seconds to turn the stimulator on, and the stimulator display shows “XFT” LOGO for 2 seconds. Tap this button to switch between Gait mode and Training mode.
  • Page 17 WALKAIDE II USER MANUAL Press the “search” icon to search for Step 3 the stimulator. Select the stimulator in the Equipment List and Step 4 enter the home page. Select mode between Gait mode Step 5 or Training mode. MNL-0023...
  • Page 18 WALKAIDE II USER MANUAL Gait Mode Start: The app sends the Gait mode parameters and the mode start command to the stimulator, receives the stimulator’s reply, and enters the walking working interface. Pause: The app sends a Gait mode pause (stop) command to the stimulator, receives the stimulator’s reply and pauses the walking.
  • Page 19 WALKAIDE II USER MANUAL Training Mode The stimulator performs electrical stimulation based on a combination of parameters of the selected Training mode. The parameters combine 9 preset mode-s and 1 custom mode. The electrical stimulation can be adjusted after the preset mode starts, and other parameters cannot be adjusted.
  • Page 20 WALKAIDE II USER MANUAL Evaluation Mode for Pro Version Evaluation Mode: Collect the angle data generated by the stimulator during the patient’s walking. The collection duration is 60 seconds by default and the maximum is 90 seconds. The acquisition begins to draw an angle waveform and displays the countdown of the acquisition time.
  • Page 21 WALKAIDE II USER MANUAL 4.4.3.2 The APP Consists of 3 Sections: Activity, Stats, and Me. 4.4.3.2.1 Activity Gait mode Procedure Operation Description APP Interface Step 1 Set the parameters. Adjust the stimulation Step 2 intensity. MNL-0023...
  • Page 22 WALKAIDE II USER MANUAL Press and hold the button ( for 1.5 Step 3 seconds to end the session. MNL-0023...
  • Page 23 WALKAIDE II USER MANUAL Training mode Operation Procedure APP Interface Description Step 1 Set the session. Adjust the Step 2 stimulation intensity. Press and hold the button ( for 1.5 Step 3 second to end the session. MNL-0023...
  • Page 24 WALKAIDE II USER MANUAL 4.3.3.2.2 Stats There are 4 types of statistics: Day, Week, Month and Year. Week Month Year 4.3.3.2.3 Me Change your profile photo. MNL-0023...
  • Page 25 WALKAIDE II USER MANUAL Edit personal information Equipment Information In the page of Equipment, you can see the name of the stimulator and App version. MNL-0023...
  • Page 26 WALKAIDE II USER MANUAL Help Visit the Help page for Attention, Introduction, Quick Guide, and FAQ. Setting From the Setting page, you can turn on or turn off the buzzer on the stimulator, set the auto-off time, switch to Pro version, restore factory setting or Exit.

  • Page 27: Attentions

    WALKAIDE II USER MANUAL 5. Attentions 5.1 Troubleshooting Malfunction indicator will show the following troubles: 5.1.1 Electrodes Loose The malfunction indicator flashes slowly once per second. When the system detects that the electrode is loose, an indicator will display, and the device will stop running.

  • Page 28: Care And Maintenance

    WALKAIDE II USER MANUAL 6. Care and Maintenance 6.1 Maintenance for Stimulator • Always handle the stimulator carefully. • Do not expose the stimulator with too much water for long time, excessive heat or vibration. • Keep it away from children.
  • Page 29 WALKAIDE II USER MANUAL 6.6 Battery Safety Please charge this device only with the original power adapter and do not use the device while charging. The device needs about 8 hours to charge when completely drained of power. The device is designed to work for 10 hours with a full charge.

  • Page 30: Faq & Troubleshooting

    WALKAIDE II USER MANUAL 7. FAQ & Troubleshooting Q1. What should I do if the stimulation intensity is weak? • Adjust the intensity through the stimulator or the app. • Adjust the position of the electrode. • If the stimulator battery is low, please charge it in time.
  • Page 31 WALKAIDE II USER MANUAL Q6. What should I do if there is sporadic strong electrical stimulation? • Wet the skin with some water or the connect gel so as to increase the conductivity between the electrode and the skin. •...

  • Page 32: Product Specifications

    WALKAIDE II USER MANUAL 8. Product Specifications 8.1 Stimulator Specifications • Communication method: Bluetooth 4.0 • Communication frequency: 2402MHz-2480MHz 8.2 Stimulator Stimulator Specifications Power Supply 3.7V rechargeable lithium battery Classification Type BF applied part, internally powered equipment ≤50μA Shutdown Current ≤120mA...
  • Page 33 WALKAIDE II USER MANUAL 8.4 Working and Storage Environment Working Conditions: • Temperature: 5~40°C (41°F~104°F) • Relative Humidity: ≤80%(Non-condensing) • Atmospheric Pressure: 86~106kPa Transport and Storage Conditions: • Temperature: -20~55°C (-4°F~131°F) • Relative Humidity: ≤93%(Non-condensing) • Atmospheric Pressure: 70~106kPa Production Date: see the label Service Life: 5 Years 8.5 Accessories...

  • Page 34: Product Classification

    WALKAIDE II USER MANUAL The wireless QoS need The XFT-2001E Foot Drop System was designed and tested to have a response rate of 10-1 00ms latency depending on system configuration. Wireless Interference The XFT-2001E Foot Drop System was designed and tested to not have interference from other RF devices (including other XFT-2001E Foot Drop System, Wi-Fi networks, cellular devices, microwaves and other Bluetooth devices).

  • Page 35: Electromagnetic Compatibility (Emc)

    WALKAIDE II USER MANUAL 10. Electromagnetic Compatibility (EMC) This equipment generates, uses, and radiates radio frequency energy. The equipment may cause radio frequency interference to other medical or non-medical devices and to radio communications. If this equipment is found to cause interference, which can be determined by turning on...
  • Page 36 WALKAIDE II USER MANUAL Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the equipment, including cables specified by the manufacturer, Otherwise, degradation of the performance of this equipment could result.
  • Page 37 WALKAIDE II USER MANUAL Table 2 Guidance and manufacturer’s declaration - electromagnetic immunity This equipment is intended for use in the electromagnetic environment specified below. User should assure that it is used in such an environment. IEC60601 test Compliance Electromagnetic environment...
  • Page 38 WALKAIDE II USER MANUAL Table 3 Guidance and manufacturer’s declaration - electromagnetic immunity This equipment should be used in the electromagnetic environment specified below. User should assure that it is used in such an environment. IEC60601 test Compliance Electromagnetic environment -...
  • Page 39 WALKAIDE II USER MANUAL 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.
  • Page 40 WALKAIDE II 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 41: After-Sales Service

    WALKAIDE II USER MANUAL 11. After-sales Service The product is provided with a two-year warranty starting from the date of purchasing. XFT will not provide free repair for the malfunctions caused by the following behaviors: • Disassemble or modify the product without authorization.

  • Page 42: Use Specification

    WALKAIDE II USER MANUAL 12. Use Specification Item Description Product name Nerve and Muscle Stimulator Product model XFT-2001E Intended use/indications During the swing phase of walking, electrically stimulates the for use appropriate never/muscles that cause ankle dorsiflexion and may thus improve the individual’s gait. Medical benefits of Functional...

  • Page 43: Warranty Card

    WALKAIDE II USER MANUAL Warranty Card Product Name: ____________________________ 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...
  • Page 44 WALKAIDE II USER MANUAL Product Name: Nerve and Muscle Stimulator Model No.: XFT-2001E 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 Shanghai International Holding Corp.

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Xft-2001e

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