XFT-2001E Nerve and Muscle Stimulator (Trade name: Foot Drop System) User Manual Caution: Federal law restricts this device to sale by or on the order of a practitioner licensed by the law of the State in which he/she practices to use or order the use of the device.
Content 1. For Your Health and Safety ................................................................................................................................... 3 2. Overviews ............................................................................................................................................................ 10 3. Product Illustration ...............................................................................................................................................
1. For Your Health and Safety To avoid any danger or loss caused by inappropriate use, please read this manual carefully; In the precautions, the hazards and losses caused by improper use are stated, and the safety precautions are divided into three parts: “contraindications”, “warning” and “attention”; Please keep this manual carefully.
Do not touch the charging connector/battery and the patient simultaneously when charging/using. Warning The safety of usage during pregnancy or menstruation has not been determined. Electrode positioning and stimulation parameters’ setting should be conducted by professionals. If you keep feeling pains or rash, please stop using this product. Please do not position the electrode in the area of malignant neoplasms, neck arteries (throat) or thrombus.
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.
Table 2 Guidance and manufacture’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. Immunity test IEC60601 test level Compliance level Electromagnetic environment - guidance Electrostatic ±8kV contact ±8kV contact Floors should be wood, concrete or ceramic discharge (ESD) ±2kV, ±4kV, ±8kV, ±2kV, ±4kV, ±8kV, tile.
Table 3 Guidance and manufacture’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.
a) The ISM (industrial, scientific and medical) bands between 0.15 MHz and 80 MHz are 6.765 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 1.8 MHz 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.
Table 4 -Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Table 5 Recommended separation distance between portable and mobile RF communications equipment and the Nerve and Muscle Stimulator The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
interference. Following recommended distance is calculated according to the maximum output power of the communication equipment. Rated maximum output Separation distance according to frequency of transmitter (m) power of transmitter (W) 150kHz -80MHz 80MHz -800MHz 800MHz -2.7GHz 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.
2.4 Use Cycle Adhere to the principle of gradual progress when using XFT-2001E. Cycle st 1 week 2nd week 3rd week & later gait mode training mode Walk for 15-60 minutes a day Walk for 1-4 hours a day Walk for 4-8 hours a day every morning and evening, 15 minutes each time every morning and evening, 20 minutes each time every morning and evening, 20 minutes each time Note: take off the cuff for 15 minutes after each use. 3. Product Illustration 3.
3.2 Operation Panel 3.2.1 Operation buttons Cuff Electrical stimulation intensity adjustment button Switch/Mode composite button OLED display Electrical stimulation intensity adjustment button This unit contains 3 buttons (1 switch / mode composite button, 2 electrical stimulation intensity adjustment buttons), and 1 OLED display.
Electrical stimulation output prompt: When the unit is in the state of electrical stimulation, the display will show the lightning symbol, and the electrical stimulation will stop showing the electrical stimulation intensity. When the gait mode is activated, there will be a “bee” sound prompt for each output of the electrical stimulation (the sound can be muted by the APP software setting).
4.1.2 Use separately Please check if the Stimulator is fully charged before use. If necessary, please charge the unit; when charging, the main unit display will indicate the icon.
4.1.3.1 Install APP 1) First install the XFT-2001E foot drop APP on your mobile phone. Download the APP from APP Store, register an account and remember your account and password when log in for the first time. Turn on the XFT-2001E Stimulator, open the Bluetooth on your mobile phone and run the APP to connect the Stimulator. Mobile phone hardware requirements: iPhone 5s and subsequent release models of the iPhone. Mobile phone software environment: system environment: IOS 8.x/9.x/10.x/11.
Log in interface interface Search Stimulator List of Stimulators Choose mode Successful connection interface Successful connection Choose one mode Gait mode – Start: The App sends the gait mode parameter and the walking start command to the host, receives the host reply, and enters the walking working interface. – Pause: The App sends a gait mode pause (stop) command to the host, receives a reply from the host, and pauses the walk.
– Under the gait mode, user can choose among smart mode, normal mode, and manual mode. Click the “smart mode” position to pop up the mode selection list and select one. a. Smart mode: The host automatically calculates the tilt angle A of the electrical stimulation and the tilt angle B of shutting down electrical stimulation according to the gait data of the first four steps of the patient.
– Stop: After long press and stop for 2s, send the evaluation mode stop command to the host, receive the host 4 reply, and the evaluation mode stops. – The evaluation mode stops calculating the reference parameters based on the collected data. The collected data needs to meet certain conditions before the reference parameters can be calculated, otherwise the prompts are re-acquired. 4.2.
5.4 Skin Care Before and after using the device, please examine the skin, it is normal that skin slightly turns red, which shows faster blood flow. Allergy Prevention Advice: Do not position on the skin with makeup or oil. Remove arm’s hair for better electrical conductivity. Electric razor or a pair of scissors is recommended. If any skin irritation or allergy occurs, please stop using the stimulator immediately and follow doctor’s instructions. Do not position on allergic area. 6.
Q2. After turning on the training mode or gait mode on the unit, although the indicator light is on, there is no electrical stimulation reaction. A. -Check if the host is tied and close to the skin. -Check if the current intensity set by the host is adjusted to the appropriate intensity. -Add some water to the surface of the electrode sheet to increase the conductivity of the electrode sheet. Q3.
Wave form Asymmetric biphasic balanced wave Frequency 16-50Hz (±10%), respectively in 16、20、25、33、40、50Hz Pulse Width 50-300μs (±10%), respectively in 100、150、200、250、300μs Output intensity 0-90mA (±10% or ±2mA, whichever is greater, with 500Ω load) Dimension 419*103*13mm 8.3 Power Adapter Dimension 71*41*31.5mm Input AC100-240V, 50-60Hz, 0.3A Output DC 5V, 1.2A 8.
10. After-sales Service 1. The product is provided with a two-year warranty starting from the date of purchasing. 2. XFT will not provide free repair for the malfunctions caused by the following behaviors: Disassemble or modify the product without authorization. Accidentally blow or drop the product during use or transportation. Lack of reasonable maintenance. Operate not according to the instruction. Repaired by unauthorized repair store. 3.
