XFT Medical XFT-2003E User manual

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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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. Product Specifications..............................................................................................40
9. Troubleshooting........................................................................................................43
10. Frequently Asked Questions ..................................................................................44
11. Electromagnetic Compatibility (EMC).....................................................................46
12. Use Specification....................................................................................................52
13. After-Sale Service ..................................................................................................53

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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.
NMES: Neuromuscular electrical stimulation is the elicitation of muscle contraction
using electric impulses.
ETS: EMG triggered electrical stimulation.
PAS: Power assistant stimulation.
UE: Upper Extremity

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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.
•Please read this manual carefully.
List of Symbols
Contraindications, that may cause danger
Mandatory requirement or may cause an injury or physical discomfort
Type BF Equipment
Warning
Non-Ionizing Radiation
Date of Manufacture
Manufacturer
This product must not be disposed of with other household waste
Refer to user manual
Serial Number
The number of the notified body (0123)
European Authorized Representative
Fragile
Keep upward
Keep dry
Degree of Ingress Protection (for Control Unit)
Temperature limit
Humidity limitation
Atmospheric pressure limitation
Consult instructions for use
Medical device
Single Patient-multiple use

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Contraindications
•Powered muscle stimulators should not be used on patients with cardiac demand
pacemakers.
•Do not use with electronic monitoring equipment, NMR-imaging, pace-maker,
defibrillator or high-frequency medical device.
•Do not use if you have a history of autonomic dysreflexia.
•Do not use FES following recent surgery where muscle contraction may disrupt the
healing process.
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.
•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.
•Stimulation should not be applied transthoracically in that the introduction of
electrical current into the heart may cause cardiac arrhythmias.
•Stimulation should not be applied over swollen, infected, or inflamed areas or skin
eruptions, e.g., phlebitis, thrombophlebitis, varicose veins, etc.
•Stimulation should not be applied over, or in proximity to, cancerous lesions.
•The safety of usage during pregnancy has not been determined.
•Electrode positioning and stimulation parameters’setting should be conducted by
professionals. If you keep feeling uncomfortable stimulation or experience a skin
irritation or rash please stop using this product.
•Please do not position the electrode in the area of malignant neoplasms, neck
arteries (throat) or thrombus.
•Please do not position the electrode on the affected skin or other affected area,
such as fracture and dislocation.
•Please use with caution when the arteries of used area 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 used areas have structural deformity.
•This product should be prescribed by a physician.
•Please stop using this product if the body shows any unforeseen adverse medical
condition while using this device.

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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.
•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.
•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. When there is a tendency to hemorrhage following acute trauma or
fracture;
b. Following recent surgical procedures when muscle contraction may
disrupt the healing process;
c. Over the belly of a pregnant women.
d. Over areas of the skin which lack normal sensation.
•Some patients may experience skin irritation or hypersensitivity due to the electrical
stimulation or electrical conductive medium. The irritation can usually be reduced by
using an alternate conductive medium or alternate electrode placement.
•Electrode placement and stimulation settings should be based on the guidance of
the prescribing practitioner.
•Powered muscle stimulators should be kept out of the reach of children.
•Powered muscle stimulators should be used only with the leads and electrodes
recommended for use by the manufacturer.
•Powered muscle stimulators should not be used while driving, operating machinery,
or during any activity in which involuntary muscle contractions may put the user at
undue risk of injury.
•Patients who use the device at home need to be trained by a doctor and follow the
treatment plan set by their doctor.
Adverse Reactions
Skin irritation beneath the electrodes has been reported with the use of powered
muscle stimulators.

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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. The device
is also equipped with an evaluation function to establish baseline data and threshold
levels as well as track rehabilitation progress to help medical professionals customize
evidence based, objective and effective rehabilitation treatment programs for each
patient.
Innovations:
•Collection and processing technology that records the patient’s EMG signals.
•EMG triggered stimulation to assist the central nervous system in a more natural
recovery process.
•The latest generation of real-time Power Assistant Stimulation based on EMG.
•A combination of biofeedback interactive games and rehabilitation training based on
EMG.
•Multiple training modes utilizing a rehab focused smart phone app.
2.2 Treatment Principle
The XFT-2003E detects and
analyzes the patient’s EMG signals in
real time through the electrode and
then simultaneously delivers low
frequency comfortable electrical
stimulation according to the EMG
signal which in turn will evoke muscle
contraction and enable patients to
actively participate in activities of
daily living.

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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)
1) Increase or maintain hand range of motion
2) Reduce muscle spasms
3) Retard muscle atrophy
4) Reeducate muscles
5) Increase local blood circulation

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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
No.
Parts
Picture
Description
1
Power Adapter
The Power Adapter
and Charging Cable
are used to charge
the device.
2
Charging Cable
3
Electrode wire
(Optional)
Used for connecting
electrode piece and
equipment.
4
Conductive adhesive
skin electrode
(Optional)
After connecting the
electrode wire, it is
attached to the
treatment site.

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3.2 Operation Panel
3.2.1 Operation button instruction
Mode Button
Wristband
OLED Screen
Down Selection Button
Play/Pause Button
Intensity Button “-”
USB Port
Power Button
Upper Selection Button
Intensity Button “+”
Electrical
Stimulation Output
Port

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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.
•Upper/Down Selection Button: Press up button to check the stimulator version, and
switch the system language (Chinese and English are available)
•Play/Pause Button: Start or pause in NMES, ETS, PAS and EMG mode.
•Intensity Buttons: Adjust the stimulation intensity during operation. Press “+”to
increase intensity or “-”to decrease intensity.
•Intensity adjustment:
<10mA, the intensity increases by 1mA increment;
10-30mA, the intensity increases by 0.5mA increment;
>30mA, the intensity increases by 0.1mA increment;
•User can feel the stimulation each lime increasing the intensity.
•USB Type-C Port: The stimulator is equipped with a USB Type-C port for device
charging.
•Velcro Wristband: To be worn on the arm to fix the stimulator.
Metal electrodes

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3.3.2 Screen Icons
Icon
Function
Explanation
Battery level
It will flash once per second when the battery is lower than
10%, and the stimulator will stop and auto off in 5 minutes.
The stimulator will auto off in 5 seconds when the battery is
lower than 2%.
Charging
The scrolling battery icon indicates that the device is
charging, and when the battery icon shows a full battery,
the device is fully charged.
NMES Mode
Under this mode, user can download different prescriptions
from APP for different needs.
ETS Mode
Under this mode, user can set up a threshold by APP; The
stimulation will be triggered when the EMG signal reaches
the threshold.
PAS Mode
The stimulation will be triggered when user contacts the
muscle.
EMG Mode
It displays when you choose EMG mode. The columnar and
parameter represent the EMG power, train by following the
instruction, 3-second relax for 3 times and 6-second
measuring cycle, the stimulator will change the ETS
threshold to the average value of 3 times measuring data.
GAME Mode
The stimulator can connect to the APP under this mode.
Bluetooth Indicator
When you need to connect to the smart phone app please
switch to GAME mode, then you can see the Bluetooth
indicator flashes; operate the app and stimulator by
Bluetooth and you can see the Bluetooth indicator display.
Now, you can control the stimulator by the app.
Electrodes loose
Indicator
The electrodes loose indicator will display and the
stimulator will stop when the electrodes and the skin have
poor contact. Re-adjust the electrodes and tightness of the
cuff and press Play/Pause button again to restart.

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4. Setup Instruction
4.1 Use with metal electrodes
1) Peel off the transparent film from the metal electrodes;
2) Add some water to the area of skin;
3) Wear the Stimulator on the arm and make sure that the metal electrodes
attach to the extensor muscles wrist extensors.
4) Press the power button to turn on the device.
5) Press the mode button to choose the mode (NMES mode, ETS mode, PAS
mode, EMG mode, GAME mode) to start the treatment.
6) After, the treatment is complete, press the power button to turn off the device.
7) Take off the device from the arm.
8) Clean the metal electrode and the device with a soft cloth, and then store it in
the portable case.
1. Peel off the transparent
film
2. Add some water to the
area of skin
3. Wear the Stimulator
4. Press the power button
5. Press the mode Button
6. After treatment, press the
power button to turn off.
7. Remove the Stimulator
8. Clean the metal electrode

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4.2 Charging the Stimulator
1) Take out the Power Adapter and the Charging Cable from the packaging.
2) Insert the USB end on the charging cable into the USB port of the charger.
3) Connect the magnetic end of the charging cable to the charging port of the
Stimulator.
4) The battery icon will display on the screen of the Stimulator to indicate
charging.
5) The battery icon will display on the screen of the device when it is fully
charged.
1. Take out the Power
Adapter and the Charging
Cable
2. Connect the Power
Adapter and the Charging
Cable
3. Connect the Stimulator
Cable and the Stimulator
4. Battery icon on the
Stimulator
5. Fully charged

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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). The
disinfectant is a 75% medical alcohol.
•Wipe the electrode 3 times with a sponge or a soft cloth dampened with
disinfectant.
•Before using the device please use water to clean and wet the skin area where
electrodes will be attached
The Stimulator can be used with or without the app.
5.1 Uses without the App
5.1.1 Wear the Stimulator
Please wear the device on the right location according to your need.
Electrode Placement (Stimulated Muscles)
Motion
Extensor Digitorum Muscle
Finger Extension and Wrist Extension
Extensor Carpi Ulnaris Muscle
Wrist Extension, and Wrist Adduction
Extensor Carpi
Ulnaris Muscle
Extensor
Digitorum,
Muscle

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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.
5.1.3 Mode Selection
5.1.3.1 NMES
Press the Play/Pause button to start the treatment and press “+”or “-”to adjust the
intensity.
5.1.3.2 ETS
Press the Play/Pause button to start the treatment, and press “+”or “-”to adjust the
intensity. The stimulation will be triggered when user contracts the muscle and the
EMG signal reaches the threshold.
5.1.3.3 PAS
Press the Play/Pause button to start the treatment, and press “+”or “-”to adjust the
intensity. The stimulation will be triggered when user contracts the muscle.

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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.

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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.

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2) Install / Update
Click “Get”to start the installation. If it is already installed, click “Update”, wait for the
download to complete, and the installation or update is successful. XFT-2003E can be
used along with iPad, which is installed with a software (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. There is specific communication protocol between XFT-2003E and
APP software.
Software:
•Rev.VI
•The XFT-2003EApp named as SEMG-2003E system App for iOS;
•iOS：iOS 9.0 or above;
iPad Recommend:
•iPad 4 and later iPad;
•WIFI support: No;
•Network: Bluetooth;
•SSD storage: more than 16G;
Network requirements when using the APP: The APP will not be connected to the
Internet during the use of the APP, and there is no need to connect to the Internet.
Data and Device Interface:
The data in the APP is limited to internal storage access in the APP. It neither
accesses patient information data from other systems or software nor imports patient
information data into other systems or software.
The internally stored data is a patient information form and a medical treatment record
form. The APP controls the device and transmits the data from the device to the APP
according to a specific encrypted instruction protocol via Bluetooth communication.

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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.