RX only XFT-2003E User manual

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XFT-2003E
Nerve and Muscle Stimulator (Trade Name: Upper Extremity Rehab System)
User Manual
Caution: This is a class II FDA cleared medical device. Federal regulations restricts the order or delivery of this medical
device to certified clinicians licensed by the law of the State in which he/she practices to use as indicated within their scope of
practice. Order and delivery of this medical device for patient home use must be accompanied by a physician prescription.
Thanks for choosing our product. Please read this manual before use and keep it carefully.

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Content
1. For Your Health and Safety............................................................................................................................. 4
2. Overviews........................................................................................................................................................7
3. Product Illustration.......................................................................................................................................... 8
4. Setup Instruction............................................................................................................................................11
5. Operation Instruction.....................................................................................................................................15
6. Care and Maintenance................................................................................................................................... 33
7. Product Configuration................................................................................................................................... 34
8. Product Specifications...................................................................................................................................34
9. Troubleshooting.............................................................................................................................................37
10. Frequently Asked Questions...................................................................................................................... 37
11. Electromagnetic Compatibility (EMC)......................................................................................................38
12. After-Sale Service......................................................................................................................................43

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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 are categorized into sections of: danger,
warning and attention.
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
Use with Caution
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
The protection level against dust and water is IP22
Temperature limit

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Humidity limitation
Atmospheric pressure limitation
Contraindications
Do not use the device where a cancerous lesion in present or suspected.
Do not use the device if you have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic
device. Use of the device in conjunction with any of the above may cause electric shock, burns, electrical interference, or
death.
Do not use the device on an arm where a regional disorder, such as a fracture or dislocation, would be adversely affected
by motion from the stimulation.
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 pads’ 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 pads in the area of malignant neoplasms, neck arteries (throat) or thrombus.
Please do not position the electrode pads 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.
FCC warning
Any Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to

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operate the equipment.
Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC
Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This
equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions,
may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a
particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
-Reorient or relocate the receiving antenna.
-Increase the separation between the equipment and receiver.
-Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
-Consult the dealer or an experienced radio/TV technician for help.
The device has been evaluated to meet the general radio frequency exposure requirement. The device can be used in portable
exposure condition without restriction.
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not
cause harmful interference. (2) This device must accept any interference received, including interference that may cause undesired
operation.
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.
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. 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.
Stimulators should be kept out of the reach of children.
Stimulators should be used only with the leads and electrodes recommended for use by the manufacturer.
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.

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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 working
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 APP.
2.2 Treatment Principle
The XFT-2003E detects and analyzes the patient’s EMG signals in real time through the electrode sensors, and then
simultaneously delivers low frequency comfortable electrical stimulation according to the EMG signal which in turn will
evoke muscle contraction and enabling patients to actively participate in activities of daily living.
2.3 Functions and Feature
EMG detection
EMG Triggered Stimulation
Power Assistant Stimulation
Functional Electrical Stimulation

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OLED screen
Multimedia interactive biofeedback rehab training (strength training, endurance training, coordination training)
Functional electrical stimulation prescription management.
Electrode isolation technology: EMG input and stimulation output through the same electrodes.
Bluetooth 4.0
Low battery indication
Treatment time limit
Symmetric biphasic balanced wave
Rechargeable lithium battery + USB Type-C port
Auto off after 15 minutes of standby.
Electrode loose indication
2.4 Indications for Use
The Nerve and Muscle Stimulator is an electrical stimulation device indicated for the following uses:
Functional Electrical Stimulation (FES)
Improvement of hand and upper extremity 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)
Increase and/or maintain hand range of motion
Prevention and/or retardation of disuse atrophy
Increase of local blood circulation
Reduction of muscle spasms
Muscle re-education
2.5 Intended population
The device is intended to be used for patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord
injury
3. Product Illustration
3.1 Components
The XFT-2003E consists of the Stimulator, Power Adapter, Charging Cable, Electrode Cables (optional), and Hydrogel
Electrodes (optional).

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3.1.1 Stimulator
Front Back
3.1.2 Parts
No.
Parts
Picture
Remark
1
Power Adapter
and Charging
Cable
The Power Adapter and Charging Cable are
used to charge the device.
2
Electrode Cable
(Optional)
Size 1 Size 2 Size 3
The Electrode Cable is used to connect between
the device and the hydrogel electrodes.
There are 3 size Electrode Cables for choice to
meet different patient’s need.
Size 1: Electrode Cable (L= 1300mm)
Size 2: Electrode Cable (L= 468mm)
Size 3 Electrode Cable (L= 318 mm)

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3
Hydrogel
Electrodes
(Optional)
The hydrogel electrodes used for the device
have been cleared under 510(k) K132588.
While in use, they are connected to the device
through the electrode cable, providing
intramuscular stimulation to where they are
placed on. The diameter of the hydrogel
electrode is 50 mm, and the length of the lead
wire is 12cm.
3.2 Operation Panel
3.2.1 Operation button instruction
This device has 7 buttons (1 power button and 6 function buttons), and 1 USB Type-C port.
Power Button: Press and hold for 1second 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 GAME 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;
OLED Screen
Play/Pause Button
Intensity Button “-”
Power Button
Intensity Button “+”
Upper Selection Button
Mode Button
Down Selection Button
USB Type-C Port
Velcro Wristband
Electrode Port

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10-30mA, the intensity increases by 0.5mA increment;
>30mA, the intensity increases by 0.1mA increment;
User can feel the stimulation each time 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.
3.2.2 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%.
NMES
Mode
Under this mode, the stimulation will run as pre-programmed.
ETS mode
Under this mode, the stimulation will be triggered when the EMG signal reaches
the threshold.
PAS mode
The stimulation will be triggered when user contracts 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 cycles of 3-second relax plus
6-second flex..
GAME
mode
The stimulator can connect to the APP under this mode.
Bluetooth
indicator
When you need to connect to the 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.
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 that will be in contact with the electrodes.
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.

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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) Remove the Stimulator 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. Press the power button
7. Remove the Stimulator
8. Clean the metal electrodes
*User can adjust the position of the stimulator as the following picture to achieve different motion.
Electrode Placement
(Stimulated Muscles)
Motion
Extensor Digitorum Muscle
Finger Extension and Wrist Extension
Extensor Carpi Ulnars Muscle
Wrist Extension,and make the wrist adduction

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4.2 Use with electrode cable and hydrogel electrodes
Warning: DO NOT use the hydrogel electrodes for multiple times. The hydrogel electrodes are only intended to be
single used.
1) Plug the electrode cable into the electrode port of the Stimulator.
2) Connect the electrode cable to the hydrogel electrodes
3) Attached the electrodes to the desired body part i.e. shoulder, tricep, bicep or forearm flexors.
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. Press the Power button to turn the device
off.
7) Peel off the hydrogel electrodes from the body part, store the device and the accessories in the portable case
*User can adjust the position of the stimulator as the following picture to achieve different motion.
Mode
Electrode
Placement
Stimulated Muscles
Motion
ETS mode, PAS
mode, EMG mode,
GAME mode
Electrode connected
to red, yellow and
black wires
Extensor Digitorum
Muscle
Finger Extension and
Wrist Extension
EMG Test and GAME
NMES mode
Electrode connected
to red and yellow
wires
Extensor Digitorum
Muscle
Finger Extension and
Wrist Extension
ETS mode, PAS
mode, EMG mode,
GAME mode
Electrode connected
to red, yellow and
black wires
Extensor Carpi Ulnars
Muscle
Wrist Extension, and make
the wrist adduction;
EMG Test and GAME
NMES mode
Electrode connected
Extensor Carpi Ulnars
Wrist Extension, and make
Extensor
Digitorum Muscle
Extensor Carpi Ulnars
Muscle

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to red and yellow
wires
Muscle
the wrist adduction
1. Connect Stimulator and Electrode
Cable
2. Connect Hydrogel Electrodes and
Electrode Cable
3. Place Hydrogel Electrodes
4. Press the power button
5. Press the mode button
6. Press the power button
7. Remove the Hydrogel Electrodes
Extensor
Digitorum Muscle
Extensor Carpi Ulnars
Muscle

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4.3 Charging the XFT-2003E Upper Extremity Rehab System
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 Type-C end on the charging cable to the charging port on 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
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% ethyl alcohol.
Wipe the electrode 3 times with a sponge or a soft cloth dampened with disinfectant to disinfect the product surface for at
least 30s.
Before using the device please use water to clean and wet the skin area where electrodes will be attached.

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The Stimulator can be used with or without the APP.
5.1 Use without 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 Ulnars Muscle
Wrist Extension,and make the wrist adduction
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 Play/Pause button to start the treatment and press “+” or “-” to adjust the intensity.
Extensor Carpi
Ulnars Muscle
Extensor
Digitorum Muscle

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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 the user contracts the muscle and the EMG signal reaches the threshold.
5.1.3.3 PAS
Press Play/Pause button to start the treatment, and press “+” or “-” to adjust the intensity. The stimulation will be triggered
when user contracts the muscle.
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 the application.
5.2 Use with the APP
Download or update APP
Connect to WiFi
Check in “Settings” to see if your iPad is connected to a WiFi network. If not connected, select the WiFi that can be connected
and enter the password to connect.

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Install / Update
Using your iPad, search for “SEMG-2003E” in App Store. Click "Get" in the below figure to start the installation. If it is already
installed, click "Update", wait for the download to complete, and the installation or update is successful.
APP operation environment:
The New iPad, and subsequent iPad.
Hardware Requirement:

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Software Requirement: iOS 9.0 or later
Requirement of security software: no
Requirement of Internet: BLE
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.
5.2.1 Wearing the Stimulator
Wear the device at the correct location according to your need and corresponding motor response. Add some water to the area
of skin that will be in contact with the electrodes.
5.2.2 Power on
Hold the power button for 1 second and you will see following interface: The display will go to the default NMES mode in 3
seconds. Press the mode button to switch and select among NMES, ETS, PAS, EMG, GAME mode.
5.2.3 Connect with APP
Press “Mode” button to select the “GAME” mode on the stimulator.
Run SEMG-2003E APP on the iPad.
Account registration is required for the first use.
Enter the account number, password and confirmation password as required.
If you forget your password, you can click to change it.
Enter and confirm the password as required.
Log in on the iPad.
Click “Search” to search the Stimulator.
Choose the Stimulator and Click “Connect”.
Enter the home interface on the iPad.

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1.Select GAME mode
2.Run the SEMG-2003E APP on the
iPad
3.Register an Account
4.Log in the account、Password、Confirm
Password
5.Change Password
6.Enter Password and Confirm
Password
7.Log in on the iPad
8.Search device
9.Connect device
10.APP home page
5.2.4 Create Patient Information
5.2.4.1 Click the patient icon to enter patient list page.
5.2.4.2 Click “+” icon to add patient record.
5.2.4.3 Edit the patient information and Save.