XFT-2001EA G4 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 ....................................................................................................................................................................................... 8 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.
Warning 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. Stimulation should not be applied over the neck or mouth. Severe spasm of the laryngeal and pharyngeal muscles may occur and the contractions may be strong enough to close the airway or cause difficulty in breathing.
The device has been evaluated to meet general RF exposure requirement. The device can be used in portable exposure condition without restriction. Precautions Safety of powered muscle stimulators for use during pregnancy has not been established. Caution should be used for patients with suspected or diagnosed heart problems. Caution should be used for patients with suspected or diagnosed epilepsy. Caution should be used in the presence of the following: a.
Table 1 MANUFACTURER’S DECLARATION-ELECTROMAGNETIC EMISSION This equipment is intended for use in the electromagnetic environment specified below. User should assure that it is used in such an environment. Emissions test Compliance Electromagnetic Environment - Guidance This equipment uses RF energy only for its internal function. Its RF RF emissions, Group 1 emissions are very low and are not likely to cause any interference in CISPR 11 nearby electronic.
of a typical location in a typical commercial or IEC 61000-4-8 hospital environment. Note: UT is the A.C. mains voltage prior to application of the test level. Table 3 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.
Table 4 Recommended Separation Distance This device can be used under the environment that radiated RF disturbances are controlled. User should maintain a minimum distance between portable and mobile RF communications equipment to prevent electromagnetic interference. Following recommended distance is calculated according to the maximum output power of the communication equipment.
2.4 Use Cycle Adhere to the principle of gradual progress when using XFT-2001EA. Cycle 1st week 2nd week rd 3 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. Operation Instruction 4.1 How to wear G4? This product can be used separately or with APP software. 4.1.2 Use separately Please check if the Stim Unit is fully charged before use. If necessary, please charge the unit; when charging, the main unit display will indicate the icon.
Log in Search Stim Unit 4.1.3.2 Wear the Stim Unit Preparations: clean the covered area with a wet towel and keep the skin moist. If the hair is more, you can trim it. Sit on a comfortable stool, relax the affected leg and bend naturally. Place the Stim Unit to correct position under the knee. 4.1.3.
List of Stim Units Successful connection interface Choose mode Choose one mode Gait mode – Start: The App sends the gait mode parameter and the walking start command to the Stim Unit, receives the Stim Unit reply, and enters the walking working interface. – Pause: The App sends a gait mode pause (stop) command to the Stim Unit, receives a reply from the Stim Unit, and pauses the walk.
Gait mode interface Start gait mode – 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 Stim Unit 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.
Choose a training program Note: 1-9 Built-in 9 training modes with fixed parameters; custom parameters can be adjusted. Evaluation mode – Evaluation mode: Collect the angle data generated by the Stim Unit during the patient's walking. The collection duration is 60s by default and the maximum is 90s. The acquisition begins to draw an angle waveform and displays the countdown of the acquisition time. Can stop in the middle. The acquisition is completed to display the evaluation results.
5. Attentions 5.1 Device Power Off Force shut down: Press the shutdown button. System shut down: 1) When the treatment duration set by the channel has ended, the functions stop. 2) When the battery voltage is low, the system will automatically shut down. 3) The Stim Unit will automatically shut down when it is in standby (no electrical stimulation output) for 2 hours. 5.2 Troubleshooting Malfunction indicator will show the following troubles: 5.2.
Store the battery/battery pack in a cool, dry place. Stay away from children. If swallowed, contact doctor immediately. Avoid sealing the battery compartment and ensure ventilation ※Rechargeable battery maintenance instructions Periodic charge and discharge: If the unit is not used for a long time (when the battery is stored for more than 6 months), it is recommended to do it once for the Stim Unit. 7. FAQ & Troubleshooting Q1. What should I do if the electrical stimulation intensity is weak? A.
Communication frequency: 2.4-2.4835GHz 8.2 Stim Unit Power DC3.7V, rechargeable lithium battery Safety class Internal power supply type BF type equipment Shut down current ≤50μA Working current ≤120mA Stimulation wave Biphasic asymmetric balanced wave Frequency 16-50Hz (±10%) Pulse 100-300µs (±10%) Output current & voltage Output current: load impedance 500Ω, maximum 90mA Dimension 413*104*17mm Weight 139g±10g 8.3 Power Adapter Dimension 71*41*31.5mm Input AC100-240V, 50-60Hz, 0.
i) Permanent or non-permanent installation: This product is a non-permanent installation. ※Please handle this product in accordance with the national regulations on the handling of electronic products. 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.
Eiffestrasse 80 D-20537 Hamburg Germany US Agent: Yang LingYun 605 Sherwood Forest Place, Cary, North Carolina Cary , NC 27519 Phone: 919 4751044 Ext Email: Usagency@126.Com Date：2018/12/17 Doc. No.
