RX only XFT-2003EA User manual

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XFT-2003EA
Nerve and Muscle Stimulator (trade name: Hand 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................................................................................................................................13
6. Care and Maintenance..............................................................................................................................29
7. Product Configuration..............................................................................................................................30
8. Product Specifications..............................................................................................................................30
9. Troubleshooting........................................................................................................................................32
10. Frequently Asked Questions................................................................................................................. 33
11. Electromagnetic Compatibility (EMC).................................................................................................34
12. After-Sale Service.................................................................................................................................40

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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.
EMG: Surface EMG uses electrode like sensors to assesses muscle function by recording muscle activity from the surface
above the muscle on the skin
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 injuries caused by inappropriate use and 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
IPX6
The protection level against water is IPX6
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-2003EA while receiving any MRI scan.
Do not use the XFT-2003EA 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.
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.
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 not be used while driving, operating machinery, or during any activity in which involuntary muscle

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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.
2. Overviews
1) Product Introduction
XFT-2003EA 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 working modes utilizing a rehab focused smart phone app.
2.2 Treatment Principle
The XFT-2003EA 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 enabling patients to actively participate in activities of daily living.
2.3 Functions and Feature
EMG detection

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EMG Triggered Stimulation
Power Assistant Stimulation
Functional Electrical Stimulation
OLED screen
Multimedia interactive biofeedback rehab training (muscle training, endurance training, coordination training)
Functional electrical stimulation prescription management.
Electrode isolation technology: EMG input and stimulation output through the same electrode
Bluetooth 4.0
Electrode loose indication
Low battery indication
Treatment time limit
Symmetric biphasic balanced wave
Rechargeable lithium battery + Pogo Pin charging port
Automatic power off in 15 minutes it there is no operation
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
1) Components
The XFT-2003EA consists of the Stimulator, Power Adapter, and APP.

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3.1.1 Stimulator
3.1.2 Parts
No.
Parts
Picture
1
Power
Adapter
The Power Adapter and Charging Cable are
used to charge the device.
2
Charging
Cable
3.2 Operation Panel
3.2.1 Operation button instruction
OLED Screen
Play/Pause Button
Mode button
Power Button
Intensity Button “-”
Intensity Button “+”

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This device has 5 buttons and 1 charging port.
Power Button: Press and hold 1 for second to turn on / turn off the stimulator.
Mode Button:
a) Switch among the Modes.
b) Press and hold the mode button for 5 seconds to switch the language. The product serial number and software
version will display at the same time.
c) When the device is powered off press and hole the power button and mode button at the same time. Hold for 5
seconds to restore factory setting.
Play/Pause Button: press to start or pause the treatment, or confirm the language
Intensity Buttons: Adjust the stimulation intensity during operation. User can feel the stimulation when increasing
the intensity.
At 0-10mA, the current will increase in 1mA increment;
At 10-30mA, the current will increase in 0.5mA increment;
For more than 30mA, the current will increase in 0.1mA increment;
Magnetic charging port: For battery charging.
Wristband: To be worn on the arm to fix the stimulator.
Magnetic charging port
Metal electrodes
Wristband

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Metal electrodes: To deliver the electrical stimulation
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%.
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.
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.
5) Press the mode button to choose the mode (NEMS mode, ETS mode, PAS mode, EMG mode, GAME mode) to start

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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.Press the power button
7.Remove the Stimulator
8.Clean the metal electrodes
4.2 Charging the XFT-2003EA Nerve and Muscle 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.

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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.
The Stimulator can be used with or without the APP.
5.1 Use 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 Ulnars Muscle
Wrist Extension,and make the wrist adduction

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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 Play/Pause button to start the treatment and press “+” or “-” to adjust the intensity.
5.1.3.2 ETS
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 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 contacts the muscle.
Extensor Carpi
Ulnars Muscle
Extensor
Digitorum 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.
5.2 Use with the APP
5.2.1Download or update APP
1) 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.
2) 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.

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APP operation environment:
The New iPad, and subsequent iPad.
Hardware Requirement:
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.
5.2.2Wearing the Stimulator
Wear the device at the correct location according to your need and corresponding motor response. Add ample amounts of

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water to the area of skin that will be in contact with the electrodes.
5.2.3 Power on
Hold the power button for 1 second and you will see the 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.
5.2.4 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.
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

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10.APP home page
5.2.5 Create Patient Information
1) Click the patient icon to enter patient list page.
2) Click “+” icon to add patient record.
3) Edit the patient information and Save.
1. Click the patient icon to enter patient
list page
2. Click “+” icon to add patient record
3. Edit the patient information and Save
5.2.6 Mode Selection
5.2.6.1 NMES Mode
1) Click icon to enter the home page of NMES mode.
2) Click the prescription number to enter the prescription list page.
3) Select the desired prescription and a pop-up window will show.
4) Click “OK” to send the selected prescription to the Stimulation.
5) Another pop-up window will display to indicate that the prescription is sent successfully, click “OK” to return to the

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home page of NMES mode.
6) Click “Start” icon to start the treatment.
7) Press “+” or “-” on the stimulator to adjust the intensity.
1. Click NMES icon
2. Click the Prescription
3. Select a prescription
4. Send the selected prescription
5. Send successfully
6. Press Start icon to start the treatment
Prescription Selection:
The user can choose different prescription based on his/her needs. According to the international standard for electrical
stimulation, we have provided 42 preset prescription and 8 customizable prescription.
Preset prescriptions
No.
Parameters
Duration /
Interval
(s)
Time
(min)
Ramp up
(s)
Ramp down
(s)
Frequency
(Hz)
Pulse width
(μs)
1
3/2
5
0
0
5
250
2
5/8
22
2
1
35
150
3
8/15
20
3
1
60
50
4
6/10
11
2
2
45
100
5
3/2
5
0
0
5
200
6
5/8
17
2
1
30
200
7
8/15
16
3
1
60
200
8
6/10
11
2
2
45
200
9
3/2
5
0
0
5
200
10
5/10
17
2
1
40
200

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11
6/15
11
2
1
60
200
12
6/8
13
2
2
40
200
13
3/2
5
0
0
5
300
14
6/6
25
2
1
25
150
15
8/12
25
2
1
35
100
16
6/5
21
2
2
40
50
17
3/2
5
0
0
5
300
18
6/6
25
2
1
35
200
19
8/12
25
2
1
60
50
20
6/5
21
2
2
40
100
21
3/2
5
0
0
5
300
22
6/6
25
2
1
25
300
23
8/12
25
2
1
35
300
24
7/10
17
5
0
40
150
25
5/4
10
2
1
5
300
26
6/15
11
2
1
60
50
27
6/12
17
2
2
40
100
28
6/4
19
2
2
40
200
29
3/2
5
0
0
5
400
30
5/8
22
2
1
30
400
31
8/15
20
3
1
60
400
32
6/10
11
2
2
40
400
33
3/2
5
0
0
5
400
34
5/8
22
2
1
30
400
35
8/15
20
3
1
60
300
36
6/10
11
2
2
40
400
37
3/2
5
0
0
5
400
38
5/8
17
2
1
35
400
39
8/15
16
3
1
60
100
40
6/10
11
2
2
40
400
41
3/2
5
0
0
5
200