HEE Cure Trio MC-310A Single Channel Wireless Electric Stimulator User Manual

HEE Cure Trio MC-310A Single Channel Wireless Electric Stimulator

INTRODUCTION

Thank you for purchasing HEE Cure Trio MC-31 0A. It is the new dimension to electrotherapy solution for pain relief, muscle training, will bring much more convenient and liberating use experience.
Cure Trio MC-31 0A is a single channel wireless electrical stimulator.
controlled by smart device(e.g. smartphone, tablet).Please download the designated App [Cure Trio] to your smart device from Google Play(for Android) or App Store (for iOS) prior to use.
For safety reasons, please read all the sections on this user manual carefully and pay close attention to the warnings and safety precautions before using the Cure Trio for the first time.

INTENDED USE

TENS:
The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities(arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
It is also intended to be used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
EMS:
The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

TENS for Pain Management

TENS (Transcutaneous Electrical Nerve Stimulation) is used by health care professionals throughout the world to provide pain relief for a wide range of conditions. The popularity of TENS has grown because it is noninvasive, easy to administer and has few side-effects or drug interactions.
Mild electrical impulses generated by a stimulating device and delivered across the intact surface of the skin via conducting pads called electrodes to against pain by the theory of Gate Control and Endorphin Release.
Gate Control: According to Gate Control Theory, TENS activates large diameter non-noxious afferents which has been shown to close the pain gate at spinal segments related to the pain. So that the stimulation could have the effect of inhibiting the transmission of pain.
Endorphin Release: Other mechanisms of the pain relief mediated by TENS include the promotion of endorphin release in the brain, release of endogenous opioids has been used to explain the actions of TENS, particularly low frequency stimulation. Symptomatic relief and adjunctive treatment of pain conditions

EMS for Fitness

EMS (Electrical Muscle Stimulation), also known as electromyostimulation, is the elicitation of muscle contraction using electric impulses. The impulses are generated by a device and are delivered through electrodes on the skin near to the muscles being stimulated, and mimic the action potential that comes from the central nervous system, causing the muscles to contract.
Electrical muscle stimulation devices have been advertised to improve muscle firmness and tone in healthy individuals.

CONTRAINDICATIONS

Do NOT use the Cure Trio on:

• Undiagnosed pain conditions

• Implanted electronic devices:
  Do not use the device if have demand type cardiac pacemakers, implanted defibrillator or other implanted electronic/electrical devices.

• Epilepsy

• During pregnancy (unless medically advised)

• Patients have diminished mental capacity or physical competence who cannot handle the device properly

• Paresthesia of skin or undiagnosed skin conditions

• Abdominal or inguinal hernia

• Patients with cardiac arrhythmia

Do NOT place the electrodes:

• On carotid sinus region (anterior neck).
• On infection or lesions skin
• Apply current transcereberally (through the head).
• Over the area of the heart
• Inside mouth
• On facial area (unless medically advised)

RESIDUAL RISKS AND POSSIBLE UNDESIRABLE SIDE EFFECTS

• If mishandled, in rare cases, the adverse events associated with Cure Trio can include burn and or irritation in treatment area, e.g. skin burn, skin irritation (e.g. skin redness, itchy, rash, allergy) beneath the electrode, electric shock, shock, tingling sensation, occasional pain.
• It is recommend to replace the electrode pad or reduce stimulation intensity to comfortable level if these negative effect persist for a short time. You should stop using the device and recommend to consult with you physician If you experience above adverse reaction from the device for a long time.

SAFETY INFORMATION

• Patient with under following conditions need to consult the doctor before using the device:

  • Under the care by a physician
  • Suspected or diagnosed with heart disease
  • Patient with recent surgical procedure

• Skin irritation and burns beneath the electrodes have been reported with the use of powered muscle stimulators. If any of these symptoms occur, stop use the device and recommend to consult your doctor.

• 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.

• Patient with an implanted electronic device (for example a cardiac pacemaker) should not be subjected to stimulation unless specialist medical opinion has first been obtained.

• Stimulation should not be applied across or through the head, directly on the eyes, covering the mouth, on the front of the neck, or from electrodes placed on the chest and the upper back or crossing over the heart.

• Application of electrodes near the thorax may increase the risk of cardiac fibrillation.

• Simultaneous connection of a patient to a high frequency surgical medical device may result in burns at the site of the stimulator electrodes and possible damage to the stimulator.

• Do not use the device in the vicinity of short-wave or microwave equipment, since this may produce instability in the stimulator output.

• Safety of powered muscle stimulators for use during pregnancy has not been established.

• Caution should be used when patient is with suspected or diagnosed heart problems.

• Caution should be used in the presence of the following:

  • When there is a tendency to hemorrhage following acute trauma or fracture;
  • Following recent surgical procedures when muscle contraction may disrupt the healing process;
  • 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.

• The device should be used only with the leads and electrodes recommended for use by the manufacturer.

• The device 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.

• Do not apply stimulation while sleeping.

• Do not apply stimulation while in bath or shower.

• Keep the device out of the reach of young children, the cable can cause

• strangulation.

• Do not service and maintain the device while the device is in use. The patient may be an intended operator. The patient can use and maintain

• the device and its accessories according to this manual.

• No modification of th is device is allowed.
  The electrode pads should never touch each other or place too close together.

• Do not share electrode pads with another person. This may cause a skin irritation or infection. Electrode pads are intended for use by one person

• Always stop the device output before removing electrode pads or changing the location.

• Do not use the device on these individuals: children or infants, persons incapable of expressing their thoughts or intentions.

• Apply stimulation to only normal, intact, clean, dry, and healthy skin.

• Android device or iOS device will be as part of the ME EQUIPMENT.

• When using the device, mobile phone shall not be connected to mains or other devices.

• Use the mobile phone that meets the relevant standards: IEC 60950-1 or IEC 62368-1 or national standards based on them.

DEVICE DESCRIPTION

Descriptions of the Device

Cure Trio MC-31 0A iOS:

• iOS mobile device requires operating system iOS 12.0 or later.

Cure Trio MC-31 0A Android:

• Android device require operating system 4.4 or later.
• The Background Running function of some Android devices (e.g. Huawei / OPPO / VIVO devices or etc) is inactivated as default settings. You are requested to select “Run in Background” options yourself at your android device’s settings.

Package Content

DEVICE SETUP

Download the Cure Trio APP

Prior to use, please download the designated APP [ Cure Trio] to your smart device from Google Play (for Android 4.4 or later) or App Store (for iOS 12.0 or later).

Charge the Device

Prior to the first use, it is recommended to fully charged the device. It takes approx. 3hours to fully charged under normal room temperature.

Note: Only an adapter that complies with IEC 60601-1/UL 60601-1 and IEC 60601-1-2/En 60601-1-2 or IEC 62368 is recommended for charging. And the adapter shall have specification” input: 100-240V, 50/60Hz, 0.2A; output: 5.0V, 1 A”.

Note: When charging the Cure Trio no treatment should be performed.

Connect the Device

Press and hold the button on MC-31 0A to switch on the device.
Open Cure Trio App and select MC-31 0A Follow the instructions on the App to complete connection.

Connect the Electrodes

1. The electric shock tablet magnet male QQ into the product female button can be.
   

ELECTRODE PLACEMENT

• Attach the electrode pads on clean, dry, healthy skin, avoid placing them on top of bony areas.

For Pain Relief

Cure Trio offers solutions for multiple body pain, please position the pads either side of the painful area, on either side of the joint with pain, or the exact sites indicated by the physician, For example,

Shoulder

Attach 2 pads on either side of painful area
DO NOT place on spine, on the front of the neck or sides of the neck.

Arm & Leg

For Fitness

Cure Trio also offers solutions for muscle performance enhancement.
Please place the pads on either side of the muscle belly you want to train or relax, or the exact sites indicated by the physician, For example,

Arm

Thigh

PERFORM A TREATMENT

Description of the Cure Trio APP

1. Treatment Program
2. Level-/ Decrease Intensity
3. Level +/ Increase Intensity
4. Intensity Level
5. Increase Treatment Time
6. Treatment Time
7. Decrease Treatment Time
8. Restart
9. Start/ Pause
10. Stop
11. Treatment Mode
12. Info
13. Electrode Placement
14. Cautions
15. Use Instruction

Choose a Treatment Program

1. Tapping the buttons on the bottom bar to select a treatment mode.
2. Choose a treatment program at the top of the screen on-demand.

Start and Pause

Tap the “START”/” Restart” button to start or restart the treatment.
Tap the”Pause” /”Stop”button to pause or stop the treatment.

Adjust the Intensity

Tap the”level +” /”level -“button to increase or decrease the output intensity.

STATUS INDICATOR

Fast Flashing Green Light

Connection Completed| Steady Green Light
Working| Low Breathing Green Light

Low Battery

| The two green lights flash fast and alternately

Charging

| The two green lights blink alternately at slow speed
Fully charged| No light

PROGRAMS

Programs| Purpose| Frequency (Hz)| Pulse width (us)| Treatment Time (mins)
---|---|---|---|---
Acute Pain| Pain lasted for short period| 100| 200| 10~30
Chronic Pain| Chronic, intractable pain, e.g. chronic low back pain, pain due to sore and aching muscles, pain associated with arthritis.| 4| 200| 10~30
Muscle Firmness| To stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle firmness.| 20/3| 300| 50
Muscle Tone| To stimulate healthy muscles in order to improve and facilitate muscle performance.

To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks.

| 30~90| 250~300| 35
Low back pain| Temporary relief of pain on low back area| 5| 250| 10~30
Leg Relax| Leg muscles relax| 3~7| 200| 21

AFTER USE

• Please stop the treatment before removing the electrode pads.

• Place electrode pads on the protection film.

• Keep the main device and accessories in the storage bags.

• Make sure that the main device is switch off before cleaning.

• Wipe the device and accessories gently with a wet cloth.

• Do not use chemicals cleaners.

• Do not let water get into the internal area.

• Do not hold the device under running water, nor submerge it in water or other liquids.

  • The electrode pad can be re-usable. Wash the electrode pads when the Tone improvement of muscle adhesive surface becomes dirty and/or the pads are difficult to attach: tone and firmness, and for strengthening muscles in Wash the pad softly with your fingertips under slow running cold water the arms, abdomen, legs, for several seconds.

• Do not use a sponge/cloth/sharp object like a nail on the adhesive side.

• Do not use detergents, chemicals or soap.

• Dry the pads and let the adhesive surface air-dry completely (do not wipe with a tissue paper or cloth).

  • If the electrode pads are slightly dry, you can dip your finger into the water to wipe the electrode pads, which can restore the adhesive of the electrode pads.
  • If the pad used over 30 times no longer sticks to your skin, please replace them with new pads.
  • If the lead wire or electrode pad is broken, please replace it with the new one.
  • If replacement electrodes or lead wire are necessary, use only electrodes or lead wire that recommended or provided by the manufacturer.
  • Please storage the device in a dry and cool room and not expose the device and accessories to direct sunlight.
  • Please keep the device inaccessible to children.
  • Do not drop the device or throw it from height or place any heavy objects over the device.

Note:The recommended recovery time is 30 minutes to warm from the minimum storage temperature between uses-10ºc until the equipment is ready for use when the ambient temperature is 5ºc. The recommended recovery time is 30 minutes to cool from the maximum storage temperature between uses 55ºc until the equipment is ready for use when the ambient temperature is 40°C.

TROUBLESHOOTING

Cannot connect to the smart device

If the connection is disable or the device is switch off?
Switch on the device, open Cure Trio App and select MC-31 0A, follow the instructions and allow the permissions requested on the App, and pair on Cure Trio APP. If problem keep occurring, restart the mobile device and/or MC-310A.

Is the smart device at a lower version?
Check the system version on smart device and update if it is low.

Unpleasant feeling during treatment

Do place electrodes correctly?
Please place the electrodes on the bulk of muscles or painful area with intact skin accordingly.
Do electrodes attach to skin tightly?
Make sure the electrode pads attach to skin tightly. If the pads are not sticky enough, please clean or replace them.
Is the output intensity too high?
Please set the output on a strong but comfortable level or based on the guidance of the prescribing practitioner.

WARRANTY

This product is guaranteed for a period of 1 year from the date of purchase against mechanical and electrical manufacturing defects.
There are no user serviceable parts inside the instrument. And any attempted repair by unauthorized persons invalidates the warranty. This does not affect your statutory rights.

Note: For any repair or change of components, please contact Netop Industrial Company Limited.The service for modifying, or repairing of device is provided ONLY by manufacturer’s authorized service personnel.

DISPOSAL

Please dispose of the device in accordance with the directive 2012/19/EU- WEEE(Waste Electrical and Electronic Equipment). If you have any queries, please refer to the local authorities responsible for waste disposal.

SPECIFICATIONS

Power Source| DC 3.7V/250mAh(A full charged battery can support the device to run for at least 12 cycles at which intensity level is 50.)
---|---
Output| Single Channel
Pulse Shape| Biphasic Square
Pulse Frequency| 3~100Hz
Pulse Width| 100- 300 µs
Output Voltage| 0~40V@1000ohm;
Max output 80V (peak to peak)@1000 ohm
Operating Condition| Temperature : 5° C to 40° C Relative humidity: 30% to 75%
Atmospheric pressure: 700 hPa to 1,0 60 hPa
Transport and Storage Condition| Temperature : -10° C to 55° C Relative humidity: 10% to 90%
Atmospheric pressure: 700 hPa to 1,060 hPa
Electrode pad Size| 70140 mm, rectangular
Service Life of Electrode pads| Around 30 times
Dimension| 8050*30 mm
Weight| 67g
Service Life of the Device| 2 years
Note: Please also note that the battery capacity will drop slowly after being put into use; therefore, it is reasonable that the usable cycles may decrease.

EXPLANATION OF SYMBOLS

| Refer to instructions manual (The sign background color: blue;The sign graphical symbol; white)
---|---
| Type BF applied apart (The applied part is electrode pad).
| Disposal in accordance with directive 2012/19/EU (WEEE)
| The name and the address of the manufacturer
| Batch code
| Serial Number
| Model Number
| Symbol for degree of protection
First number 2 “means protected against solid foreign objects of 12,5 mm ∅ and greater Second number “2” means protection against vertically falling water drops when enclosure tilted upto 15°.
| Keep Dry
| The date of manufacturing
| Medical Device

INFORMATION REGARDING ELECTROMAGNETIC COMPATIBLITY (EMC)

The devices manufactured by NETOP INDUSTRIAL CO.LTD. conform to this IEC60601-1-2:2014 standard for both immunity and emissions. Nevertheless, special precautions need to be observed:

• The devices should not be used adjacent to or stacked with other equipment. In case adjacent or stacked use is necessary, the device should be observed to verify normal operation in the configuration in which it will be used.
• Use of accessories and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

The compliance for each EMISSIONS and IMMUNITY standard can be referred to below table:

Table 1:

Table 2:

Electrostatic discharge (ESD)

IEC61000-4-2

| ±8kV contact
±2k V,± 4kV, ±8kV,±15kV air| Compliant
Radiated RF IEC61000-4-3| 10 V/ m
80 MHz-2,7GHz
80 % AM at 1 kHz| Compliant
Conducted disturbances induced by RF fields IEC 61000-4-6| 3V
0,15 MHz-80MHz
6 Vin ISM and amateur radio bands between 0,15 MHz and 80 MHz
80 % AM at 1 kHz| Compliant
Rated power frequency magnetic fields
IEC 61000-4-8| 30A/m
50 Hz or 60 Hz| Compliant
Electrical fast transients/ bursts IEC 61000-4-4| ±2 kV
100 kHz repetition frequency| Not applicable
Surges IEC61000-4-5| Line -to -line: ± 0,5 kV,± 1 kV Line-to-ground: ± 0,5 kV, ± 1 kV, ± 2 kV| Not applicable
Voltage dips IEC 61000-4 11| % UT; 0,5 cycle
At0~45~90~135~180~225~
270° and 315°
O % UT; 1 cycle
And 70 % UT; 25/30 cycles
Single phase: at 0°| Not applicable
Voltage interruptions IEC 61000-4-11| O % UT; 250/300 cycle| Not applicable

FCC Statement

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, and
(2) this device must accept any interference received, including interference that may cause undesired operation.

This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment.

CAUTION
Changes or Modifications not expressly approved by the party responsible could void the user’s authority to operate this device.

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.

MANUFACTURER

We are constantly striving to delight out customers with our products and customer service, we value your opinion and feedback on our device as this helps us to develop and continually improve.

We would be grateful if you’d share your thoughts in reviewing this product. Note: When the user and/or patient be aware of that any serious incident that has occurred in relation to the device, please report the case to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

Netop Industrial Company Limited, Dapu Industrial Estate,
GangziVillage, ChangpingTown, Dongguan City,
Guangdong Province, China
Tel: +86 (769) 83999008
Fax:+86(769)83999238

Documents / Resources

| HEE Cure Trio MC-310A Single Channel Wireless Electric Stimulator [pdf] User Manual
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