EmeTerm US02 TENS Targeted Neuromodulation Instruction Manual

Instruction Manual
TENS Targeted
Neuromodulation

US02 TENS Targeted Neuromodulation

Version NO.: US02

Note
Please fully charge the battery before using it for the first time.
Please clean the skin before wearing the device.
Apply the electrodes to the correct position (P6).
The battery life lasts up to 40 hours.
Users may adjust the intensity of the device to best suit their personal comfort or to address the severity of the symptoms.
Rechargeable Lithium-ion batteries are potentially hazardous and can present a serious FIRE HAZARD, SERIOUS INJURY and/or PROPERTY DAMAGE if damaged, defective or improperly used.
EmeTerm Return & Help Center
https://www.emeterm.com/pages/how-to-use
For any non-user related product failure, please feel free to contact us for free replacement.

Tips

How to optimize your experience?

1. Please carefully read the instructions and Q&A before using the device.
2. Apply cleansing wipes, conductive gel, or moisturizing fluid to the contact area of your wrist.
3. Adjust the intensity of electrical stimulation to the palm and fingertips to feel a slight tingling sensation.
4. If you are highly susceptible to motion sickness,begin using the device 30 minutes prior to the anticipated motion sickness activity such as a flight or long car ride.
5. If the temperature or humidity is too low such, as in winter, it is recommended to wear the device 30 minutes beforehand.

Is dry or sensitive skin a problem?
For dry skins, please use cleansing wipes to clean the wrist skin before wearing the device. For sensitive skins, it is recommended to alternate between wrists every 30 minutes of usage. This applies to those who are in a humid environment or have skin allergies.

Quick Start Guide **

**

I. Device features

1. Control button
2. Indicator lights
3. Wristband
4. Electrodes
5. Charging port

Battery charging

1. Connect the magnetic connector to the charging port
2. Display the capacity of battery Single click when the device powered off.

III. Wearing instructions

1. Position(P6): 2-3cm away from the transverse wrist lines, with a width of about 2 fingers. Attention:
   The device should be applied to clean and healthy skin.

2. Wear the device.
   Ensure skin is suffciently in contact with electrodes. Attention ：
   The device should be applied to the correct position (P6).

3. Slight tingling sensation may occur in the shaded area as indicated

IV. Operating instructions

V. Operating principles

1. Send the electrical pulses to stimulate the median nerve
2. Signals travel to the brain via the central nervous system
3. Stop nausea and vomiting

Manual Instruction

Name of Product
TENS device-EmeTerm
Specification and Model
YF-ZTY-E1
Packing Specification
The packing specification for each model is one piece per case. The product configuration list is shown in the following table:

Name of Accessory

|

Quantity

---|---
Main unit| One set
Wristband| One set
Instruction files| One set

Please use CE certificated adapter and charging line.
Product Structure
1. Structure of the product: Main unit, wristband.

2. Technical Parameters of Product

Output

|

Parameters

---|---
Gear range| 1| 2| 3| 4| 5
Voltage| 22.8V|    28.8V| 32.4V|  34.0V| 36V
Range of amplitude| -39.5V～+39.5V（±3V）
Oscillogram| Mode| Pulse width| Frequency
Orthogonal pulse sharp-wave| 100µs(±10%)| 33Hz(±3)

3. Battery information: 3.7V DC. 140mAh Lithium battery
Range of Application
TENS device-EmeTerm is a wearable device for the treatment of nausea and vomiting caused by motion sickness and pregnancy.
Contact Classification
Electrical Safety Applied Part is Type BF.
Duration of Contact
The maximum time of contact per use is up to 12 hours with a fully charged battery. Typically, the patient will remove the device when their symptoms are gone, therefore the the minimum duration of contact would be determined by different individual in accordance with their needs.
Cleaning Instructions
Keep the electrode area clean by using a damp cloth or alcohol. Please wipe the electrode after every use.

1. Patients who are suffering from acute inflammation, hemorrhagic tendency, arrhythmia and epilepsy;
2. People who have metal piece or cardiac pacemaker within their bodies;
3. Please consult your physician if you have any other contraindications;
4. People with craniocerebral injury or maxillo-facial injury recently;
5. Patients with brain tumor, meningitis or acute cerebrovasclar stroke;
6. Do not use this device if you have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device without  consulting professional physician. Such use could cause electric shock, burns, electrical interference, or death.

Contraindication
Warning

1. Please use the device according to the instruction manual in order to ensure a safe use.

2. Please do not use the device if you are suffering from skin ulceration, allergy, bleeding, infection or other types of open wounds.

3. Please do not use the device together with a high-frequency device. It is forbidden to put this device and a high-frequency device in the same treatment room.

4. It is not suitable for patients to adjust the device at a high gear in their first use of the device because they have not got prepared psychologically. After 2 to 3 times of treatment, patients can have gear up gradually.

5. It is not allowed to put the electrode on the unspecified part for use.

6. Patients who have medical electronic products in their bodies such as cardiac pacemakers, metal implants and so on are forbidden to use the device.

7. Patients who have metal foreign bodies in them are forbidden to use the device.

8. The electro-conductibility of the device varies with individual physique and surrounding environment, thus affecting the using effect.
   It is general to intensify the electro-conductibility by gearing up the device, tightening the wrist strap, or applying conductive paste or appropriate amount of water on the wrist.

9. It is normal that a slight tingling will develop on the wrist while wearing the device. For users who have pruritus and tingling, they may wear the device on the other wrist. Generally, the pruritus and tingling will disappear in 24 hours.

10. Please clean the device before treatment.

11. If you are in the care of a physician, consult with your physician before using this device;

12. Do not apply stimulation over your neck because this could cause severe muscle spasms resulting in closure of your airway, diffculty in breathing, or adverse effects on heart rhythm or blood pressure;

13. Do not apply stimulation across your chest because the introduction of electrical current into the chest may cause rhythm disturbances to your heart, which could be lethal;

14. Do not apply stimulation over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins);

15. Do not apply stimulation over, or in proximity to, cancerous lesions;

16. Do not apply stimulation in the presence of electronic monitoring equipment (e.g., cardiac monitors, ECG alarms), which may not operate properly when the electrical stimulation device is in use;

17. Do not apply stimulation when in the bath or shower;

18. Do not apply stimulation while sleeping;

19. Do not apply stimulation while driving, operating machinery, or during any activity in which electrical stimulation can put you at risk of injury.

20. Do not use the device on children, if it has not been evaluated for pediatric use.

21. Apply stimulation only to normal, intact, clean, healthy skin.

Precautions

1. Please consult your physician if you have any other concerns.
2. TENS devices have no curative value;
3. TENS is a symptomatic treatment and, as such, suppresses the sensation of pain that would otherwise serve as a protective mechanism;
4. The long-term effects of electrical stimulation are unknown;
5. The safety of electrical stimulation during pregnancy has not been established（EmeTerm is approved by FDA for the indications of the treatment of nausea and vomiting caused by motion sickness and pregnancy. ）;
6. You may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium (gel);
7. If you have suspected or diagnosed heart disease, you should follow precautions recommended by your physician;
8. If you have suspected or diagnosed epilepsy, you should follow precautions recommended by your physician;
9. Use caution if you have a tendency to bleed internally, such as following an injury or fracture;
10. Consult with your physician prior to using the device after a recent surgical procedure, because stimulation may disrupt the healing process;
11. Use caution if stimulation is applied over the menstruating or pregnant uterus;
12. Use caution if stimulation is applied over areas of skin that lack normal sensation;
13. Keep this device out of the reach of children.

Adverse Reactions

1. You may experience skin irritation and burns beneath when the stimulation electrodes applied to your skin;
2.  You should stop using the device and should consult with your physician if you experience adverse reactions from the device.

Usage
Wearing: Place the contact plate (two metal electrodes) of the device at the center of the inner wrist, about 2 to 3cm from the wrist crease. Please ensure the control button is close to your body side, and then fasten the wrist wrap at a suitable tightness.
Starting up:Press the control button for 3 seconds to start up the device, and then the display lights from the first gear to the fifth gear will be on in turn and at last stay at the first gear. If the button light and the gear light flash intermittently at the same time, it means the product is working normally.
Gear range: The product has five gears (1, 2, 3, 4, 5 indicating the function goes from weak to strong) which are used to adjust the intensity of function.
Users can select their suitable gears by themselves.

1. Single click (shorter than 1 second) on the control button will increase one gear. Users can know the current gear through the display light (For instance, the first three display lights and the button light will be on if the device is at the third gear.).
2. Double click on the control button will decrease one gear. Users can know the current gear through the display light.

Power off: Press the control button for 3 seconds, and the display lights from the first gear to the fifth gear will be on in turn and then go out, indicating that the device is powered off.
State of charge :

1. Single click on the control button under the power-off state will enable the gear display light to display the current state of battery capacity. The first gear to the fifth gear indicate that the battery capacity goes from 20% to 100%.
2. Reminder of low power when the product is working: the product will be power-off automatically after the button light and the gear light flash for 15s at the same time.

Charging: The device should be charged by the attached USB cable which can connect to the chargeing port and the computer’s USB port. While charging the device, the device’s charging indicator light is on while the gear display light displays the progress of charging (after it is fully charged, all of the five gear lights will be on).

Maintenance

1. Keep the device clean, and use it following the usage steps.
2. Put the device in a dry and well-ventilated place. Do not put it under the window or beside the heating installation to protect it from heating and dampness.
3. It is not allowed to expose the device to environment with strong electromagnetic interference.
4. Please turn off the power after use.

Disposal

Dispose device according to your local state/country laws.
Operating Conditions
Normal operating conditions should comply with the following requirements:

Environment temperature: 5 ℃～40 ℃
Relative humidity: 10% ～80%
Atmospheric pressure: 86kPa ～106kPa
Storage
The product should be stored in accordance with the following requirements:
Environment temperature: -20 ℃~+55 ℃
Relative humidity: 10% ～80%
Atmospheric pressure: 50kPa ～106kPa
Indoor, dry and well-ventilated, free from corrosive substances
Great pressure is not allowed to be put on the product.
Date of Manufacturing and shelf life
See the packaging.
Device shelf life: 36 months
Manufacturer: WAT Medical Technology Inc. (WAT Med)
Add.: Room703-711, No.2 North Taoyuan Road, Ningbo, Zhejiang Province, P.R.C
Tel.: 86-574-65060811
Fax: 86-574-65060815
Email: info@watmedical.com
Manufacturing Enterprise and After-sale Service Agency

Statement

MedWatch is the Food and Drug Administration’s (FDA) program for reporting serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors with human medical products, including drugs, biologic products, medical devices, dietary supplements, infant formula, and cosmetics.
If you think you or someone in your family has experienced a serious reaction to a medical product, you are encouraged to take the reporting form to your doctor.
Your health care provider can provide clinical information based on your medical record that can help FDA evaluate your report.
However, we understand that for a variety of reasons, you may not wish to have the form filled out by your health care provider, or your health care provider may choose not to complete the form. Your health care provider is not required to report to the FDA. In these situations, you may complete the Online Reporting Form yourself.
You will receive an acknowledgement from FDA when your report is received. Reports are reviewed by FDA staff. Y ou will be personally contacted only if we need additional information.
Submitting Adverse Event Reports to FDA 6 of 16 Use one of the methods below to submit voluntary adverse event reports to the FDA:
Report Online at www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home
Consumer Reporting Form FDA 3500B.
Follow the instructions on the form to either fax or mail it in for submission.
For help filling out the form, see MedWatchLearn. The form is available at www.fda.gov/downloads/aboutFDA/reportsmanualsforms/forms/ucm349464.pdf
Call FDA at 1-800-FDA-1088 to report by telephone.
Reporting Form FDA 3500 commonly used by health professionals.
The form is available at www.fda.gov/downloads/aboutFDA/reportmanualsforms/forms/ucm163919.pdf

Labels and packaging marks

No.

| Symbol|

Meaning

---|---|---
1| | Manufacturing date of product
2| | Serial number of product
3| | Batch number of product
4| | Note! Please check all documents attached
5| ****| Information of manufacturer
6| | BF type
7| | The product contains battery, so please don’t throw it away freely.
8| | Refer to the Instruction Manual
9|

IP67

| Achieve IP67 level under IEC 60529 standard

Effective Date: 2023-03-20

Attachment:EMC-IT-CE-EN60601-1-2

1. Test summary

Test Reference Standard| Test Item| Result (Pass/Fail)| Remark
---|---|---|---
Emission Measurements
CISPR 11| Conducted Emission| Pass| –
CISPR 11| Radiated Emission| Pass| –
EN 61000-3-2| Harmonic CurrentEmissions| N/A| –
EN 61000-3-3| Voltage Fluctuations and Flicker| Pass| –
Immunity Measurements
EN 61000-4-2| Electrostatic Discharge| Pass| –
EN 61000-4-3| Radio-frequencyElectromagnetic Field| Pass| –
EN 61000-4-4| Fast transients, Common Mode| Pass| –
EN 61000-4-5| Surges| Pass| –
EN 61000-4-6| Radio-frequency Common Mode| Pass| –
EN 61000-4-8| Power-frequency Magnetic Fields| Pass| –
EN 61000-4-11| Voltage Dips and Interruptions| Pass| –

2. Limit of Conducted Emission

Limits of conducted emission for AC mains power input/output ports

Frequency range MHz| Limits dB(µV)
| Quasi-peak| Average
0.15 to 0.50| 66 to 56| 56 to 46
0.50 to 5| 56| 46
5 to 30| 60| 50
Note: The lower limit shall apply at the transition frequencies.

3. Limit of Radiated Emission

Note 1: The lower limit shall apply at the transition frequency.
Note 2: Additional provisions may be required for cases where interference occurs.

4. Limit of Electrostatic Discharge

Environmental phenomenon| Test specification| Units| Performance criterion
---|---|---|---

Electrostatic Discharge

| ±8
(Contact discharge)
±2, ±4, ±8, ±15
(Air discharge)| kV (Charge voltage) kV (Charge voltage)| No performance degradation which associated with basic safety and essential performance

5. Limit of Radio-frequency Electromagnetic Field (EN 61000-4-3: 2006+A1:2008+A2:2010)

Environmental phenomenon| Test specification| Units| Performance criterion
---|---|---|---
Radio frequency electromagnetic field| 80 – 2700
3
80| MHz
V/m (unmodulated,
r.m.s)% AM (1kHz)| No performance degradation
which associated with basic safety and essential performance

6. Limit of Electrical Fast Transients

Environmental phenomenon

| Test specification| Units|

Performance criterion

---|---|---|---
AC power lines
Electrical fast transients| ±2 5/50
100| kV (open circuit test voltage) Tr/Th (ns)
Repetition frequency (kHz)| No performance degradation which associated with basic safety and essential performance
Signal and interconnecting cables
Electrical fast transients| ±1 5/50
100| kV (open circuit test voltage) Tr/Th (ns)
Repetition frequency (kHz)| No performance degradation which associated with basic safety and essential performance

7. Limit of Surges

Environmental phenomenon

| Test specification| Units|

Performance criterion

---|---|---|---
AC power lines
Surges| 1.2/50 (8/20)
±0.5, ±1 line to line
±0.5, ±1, ±2 line to earth| Tr/Th (us)
kV (open circuit test voltage)
kV (open circuit test voltage)| No performance degradation which associated with basic safety and essential performance

8. Limit of Radio-frequency Common Mode

Environmental phenomenon

| Test specification| Units|

Performance crite rion

---|---|---|---
Input AC power ports
Radio-frequency| 0.15 – 80| MHz|

A

common mode| 3
80| V (unmodulated, r.m.s)
% AM (1kHz)
Signal and interconnecting cables
Radio-frequency common mode| 0.15 – 80
3
80| MHz
V (unmodulated, r.m.s)
% AM (1kHz)|

A

9. Limit of Power-frequency Magnetic Field

Environmental phenomenon| Test specification| Units| Performance criterion
---|---|---|---
Power-frequency magnetic field| 50, 60
30| Hz
A/m| No performance degradation which associated with basic safety and essential
performance

10. Limit of Voltage Dips and Interruptions

Environmental phenomenon

| Test specification| Units|

Performance criterion

---|---|---|---
Input AC power ports
Voltage dips| 0
0.5| % residual cycle| B
0
1| % residual cycle| B
70
25| % residual cycle| C
Voltage interruptions| 0
250| % residual cycle| C

Offcial website: www.emeterm.com
Corporate website: www.watmedical.com
Email: info@emeterm.com
Designed by WAT Medical
WAT Medical Enterprise Ltd.
Add: Unit 170, 422 Richards St, Vancouver, BC, V6B 2Z4, Canada

References

• MedWatch Online Voluntary Reporting Form
• EmeTerm – EmeTerm®
• WAT Medical – Innovative smart wearable medical product supplier

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