XFT Medical WalkAide II User manual

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

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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. Product Specifications..............................................................................................30
9. Product Classification...............................................................................................32
10. Electromagnetic Compatibility (EMC).....................................................................33
11. After-sales Service .................................................................................................39
12. Use Specification....................................................................................................40
Warranty Card..............................................................................................................41

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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”and “Warnings and Precautions”.
•Please keep this manual carefully.
List of Symbols
Type BF equipment
Warning
Non-ionizing radiation
Date of manufacture
Manufacturer
Serial Number
Fragile, handle with care
Keep upward
Keep dry
The product is:
1. Dust-tight
2. Protected against the effects of temporary immersion in water.
Temperature limit
Humidity limitation
Atmospheric pressure limitation
The number of the notified body (0123)
Authorized representative in the European Community
Refer to user manual
Please dispose of the device/battery/accessory/packing in accordance with
the legal obligation in your area
Medical device
Single Patient-multiple use
Consult instructions for use

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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.
•Patients with active hemorrhage, acute purulent inflammation, malignant
neoplasms, thrombophlebitis, sepsis and cardiopulmonary failure are forbidden to
use this product.
•Do not use this product for purpose other than treatment.
•Do not apply this product to unconscious patients.
•Do not disassemble, repair or rebuild this product.
•Do not touch the charging connector/battery and the patient simultaneously when
charging/using.
Warnings and Precautions
•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.
•Use caution when positioning electrodes in areas of altered sensation.
•Do not apply electrodes to areas with compromised skin integrity.
•Muscle training might cause disorder of rehabilitation of a recent surgery; Electrode
positioning areas are not sensitive enough.
•Please use with caution when the arteries of used are a show partial occlusion,
when the patient has vascular atrophy because of hemodialysis, or when the
vascular system shows instability.
•Please use with caution if the treated areas have structural deformity.
•This product should be conducted by doctors.
•Patients should keep stable and not move the device while using this unit.
•Patients should not move the electrode or be touched while using this unit.
•Please stop using this product if the body shows any physical abnormality.
•Patients with any of the following conditions are forbidden to use this product:
–Patients with epilepsy
–Patients that are pregnant
–Patients with acute dislocations or fractures of the ankle
–Patients with regional cancer in the lower leg
–Patients with metal implants
–Patients with autonomic dysreflexia

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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. During the swing phase
of walking, the XFT-2001E electrically stimulates the appropriate muscles that cause
ankle dorsiflexion and may thus improve the individual’s gait. Medical benefits of
Functional Electrical Stimulation (FES) may include prevention/retardation of disuse
atrophy, increased local blood flow, muscle re-education, and maintained or increased
joint range of motion.
2.2 Treatment Principle
XFT-2001E Foot Drop System detects and analyzes the patient’s gait patterns in real
time through the internal tilt and accelerometer sensors, and then simul-taneously
delivers comfortable, low frequency, functional electrical stimulation (FES) to the
common peroneal nerve. This in turn will evoke muscle contract-ion and enable the
patient to actively walk with a more normalized gait. The mo-st common use of FES for
a treatment for foot drop where disruptions of the nerve pathways between the legs
and brain cause inability of the patient to lift the foot to the correct angle when walking.
2.3 Use Cycle
Adhere to the principle of gradual progress when using the XFT-2001E Foot Drop
System.
Cycle
Gait mode
Training mode
1st week
Walk for 15-60 minutes a day
Every morning and evening,
15 minutes each time
2nd week
Walk for 1-4 hours a day
Every morning and evening,
20 minutes each time
3rd week& later
Walk for 4-8 hours a day
Every morning and evening,
20 minutes each time
Note: Take off the cuff for 15 minutes after each use.

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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
No.
Parts
Picture
Description
1
Power Adapter
The Power Adapter
and Charging Cable
are used to charge
the device.
2
Charging Cable

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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. When the stimulator is turned on, press
and hold this button for 2 seconds to turn off the stimulator. In the working state, tap
this button to pause the electrical stimulation.
Intensity Buttons: Tap one of the buttons to start electrical stimulation and increase or
decrease the electrical stimulation intensity; click the up button to increase the
intensity, and click the down button to decrease the intensity.
OLED Display: Display various working states of the stimulator, such as Gait mode,
Training mode, electrode loose, low battery icon, electrical stimulation output icon,
electrical stimulation intensity, etc.
Charging Port: Users can recharge the stimulator via the charging port.

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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.
LOGO
Gait Mode
Training Mode
Mode switching
After the stimulator is turned on or it is paused, press to switch the mode.
Gait Mode
Training Mode
Start/Pause
When the stimulator is in the pause state, press or to activate the electrical
stimulation intensity; press the up button to increase the intensity, and press the down
button to decrease the intensity. The display will show the corresponding intensity value.
Stimulation Intensity
Stimulation Intensity
Electrical Stimulation Output Prompt
When the stimulator is delivering electrical stimulation, the display will show the
lightning symbol. When the Gait mode is activated, there will be a “beep”prompt for
each output of the electrical stimulation (the sound can be muted by the app).
Lightning Symbol
Stimulation Intensity

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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.
Electrode Loose
Electrode Loose
Low Battery / Charging Prompt
When the stimulator is in low battery, there will be a battery icon flashing once per
second on the screen. The dynamic charging icon is displayed while charging, and the
full battery icon is displayed when charging is completed.
Low Battery, flash
once per second
Charging
Charging
Full Charge
Automatic Screen Saver
The screen saver will sleep in 30 seconds if no operation on the stimulator; and then
screen saver icon will show up in 1 minute and move from left to right.
Screen Saver Icon

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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:
•System environment: iOS 9.0 or later.
Android:
•Android 6.0 and later.
•Security software: none.
•Network requirements: Bluetooth communication.
Data Transmission
Data is transmitted between app and Stimulator via Bluetooth communication.
Storage Medium
APP software data is stored in the mobile terminals.
User Login
Username and password shall only be set by user.
Detection, response and recovery of network security events
Data transmission between app software and device is carried out through specific
Bluetooth service channel, data format and data verification requirements are required
at the same time, which can avoid connection and control of other devices or software.
When the connection between app software and device is interrupted during usage,
app software will give a reminder of disconnection, and you can control the device by
pressing the button on the device.
After the Bluetooth connection between the app software and the device is
disconnected, the app will search and connect the device that has been turned on if the
device needs to be re-controlled by the app.
Software Update
The latest version of the app can be updated and installed through the app Market. If
your phone is iOS system then you can update through App Store, and if is Android
system you can update it through Google Play.

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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). The
disinfectant is a 75% medical alcohol.
•Wipe the electrode 3 times with a sponge or a soft cloth dampened with
disinfectant.
4.2 How to Use XFT-2001E?
XFT-2001E can be used with or without app.
Please check if the stimulator is fully charged before use. If necessary, please charge
the stimulator. The display will indicate the battery icons when charging.
Connect charging cable to
the power adapter.
Connect charging cable to
the stimulator.
Connect power adapter to
the power outlet.
How to charge the Stimulator
During use, if you find that the intensity is weak or the low battery icon appears on the
screen, please charge it in time. It needs about 8 hours to fully charge the stimulator,
and it can be used for about 10 hours when fully charged.
Please shut down the stimulator and store it if it is not in use.
Note: Please use the power adapter supplied by XFT. Do not use the stimulator while
charging.

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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.
Position the cuff on the leg
below the knee.
Align the vertical edge of the
stimulator with the tibia.
Fasten the cuff, but don’t
violently pull the cuff.
To optimize individual
function, the stimulator
position might be adjusted
slightly, please consult
the fitter.

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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.
LOGO
Gait Mode
Training Mode
When the stimulator is in the pause state, press or to activate the electrical
stimulation intensity; press the up button to increase the intensity, and press the down
button to decrease the intensity. The display will show the corresponding intensity value.
Stimulation Intensity
Stimulation Intensity
Note: In order to allow the skin area covered by the stimulator to breath and to prevent skin
irritation and redness, stimulation should be suspended, and the stimulator removed at regular
intervals. This allows the skin to breathe fully and in the process of using the product.
4.3.3 Power off
When the stimulator is turned on, press and hold the Power/Mode Button for 2 seconds
to turn it off.

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4.4 Use with App
4.4.1 Install App
Procedure
Operation Description
Step 1
Go to App Store or Google Play. Search “Foot Drop
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.
4.4.2 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 to the correct position under the knee.
Position the cuff on the leg
below the knee.
Align the vertical edge of the
stimulator with the tibia.
Fasten the cuff, but don’t
violently pull the cuff.
To optimize individual function,
the stimulator position might be
adjusted slightly, please consult
the fitter.

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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.
4.4.3.1 Login the app and connect the Stimulator to the app via
Bluetooth.
Procedure
Operation
Description
App Interface
Step 1
Open the Bluetooth
on your mobile
phone
and run the app.
Step 2
Enter your name
and Password, and
press the Login
icon to login.

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Step 3
Press the “search”
icon to search for
the stimulator.
Step 4
Select the
stimulator in the
Equipment List and
enter the home
page.
Step 5
Select mode
between Gait mode
or Training mode.

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Gait Mode
1) 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.
2) Pause: The app sends a Gait mode pause (stop) command to the stimulator,
receives the stimulator’s reply and pauses the walking.
3) Continue: The app sends the Gait mode (start), and you have to adjust the
intensity again. After receiving the stimulator’s reply, the walking work
continues.
4) End: After long press and stop for 1.5 seconds, the Gait mode stop command
is sent to the stimulator; the app receives the stimulator’s reply, and the Gait
mode stops.
Under the Gait mode for Pro Version, user can choose among smart mode, normal
mode and manual mode.
1) Smart Mode: The stimulator automatically calculates the tilt angle A to start
the electrical stimulation and the tilt angle B to end the electrical stimulation
according to the gait data of the first four steps of the patient. The parameters
hat can be adjusted are the electrical stimulation intensity, frequency and
pulse width in the lower-level interface of the “Parameter Settings.”
2) Normal Mode: The stimulator performs electrical stimulation according to the
set parameters. The parameters that can be adjusted are the electrical
stimulation intensity, and the frequency, pulse width, tilt angle A, tilt angle B,
duration, delay time, ramp up and ramp down in the lower-level interface of
the “Parameter Settings.”
3) Manual Mode: The clinician can manually press the “Start”button to deliver
stimulation at certain time by observing the patient’s gait when the patient is
walking. The parameters that can be adjusted are the electrical stimulation
intens-ity, frequency and pulse width in the lower-level interface of the
“Parameter Settings.”

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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. All parameters can be adjusted in the custom
mode.
1) Start: The app sends the Training mode parameters and the mode start
comma-nd to the stimulator, receives the stimulator’s reply and enters the
Training work interface.
2) Pause: The app sends a Training mode pause (stop) command to the
stimulator, receives the Stimulator’s reply, and the Training is suspended.
3) Continue: The app sends the Training mode (start), and you have to adjust
the intensity again. After receiving response, and the training work continues.
4) End: After long press and stop for 2 seconds, send the Training mode stop
co-mmand to the stimulator, receives the Stimulator’s reply and the Training
mode stops.
Choose one mode
9 pre-set Training modes with fixed parameters; custom mode with adjustable
parameters.

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Evaluation Mode for Pro Version
1) 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. You can stop in the
middle. The acquisition is completed to display the evaluation results.
2) Start: The App sends an Evaluation mode to start the command to the
stimulator, receives the Stimulator reply, and enters the evaluation work
interface.
3) End: After long press and stop for 1.5 seconds, send the Evaluation mode
stop commando the stimulator; the App receives the stimulator’s reply, and
the eval-uation mode stops.
4) 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.
Evaluation Mode
Start Evaluating
Shut Down
When the stimulator is turned on press and hold the Power/Mode Button for 2 seconds
to turn it off.