NESA XSIGNAL® non-invasive neuromodulation medical technology has health certification, certification in accordance with the CE marking directive, 93/42/CEE, by a notified body before using the CE marking that can be verified at the following website of the notified body: 

https://www.imq.it/en/certified-products-database

In addition, the company has manufacturing of sanitary products (ISO 13485). This quality management standard that has been specially designed for manufacturers of medical devices and products. This is a series of essential requirements for manufacturers in this sector, it is a way of demonstrating a commitment to the quality of the manufactured sanitary products.

This Standard is internationally recognized.

Contraindications for this type of treatment are: • Implanted electronic devices.

• Pregnant.
• Cancerous or neoplastic processes.
• Epilepsy.
• Internal bleeding.
• Do not apply electrodes to skin in poor condition, with ulcerations or wounds.
• Acute febrile processes.
• Acute thrombophlebitis.
• Significant change in sensitivity.

There are a number of precautions to be taken into account by the professional, which are:

• Avoid contact with electronic devices by the patient. • Do not put electrodes on endocrine glands without the supervision of a doctor.
• Cardiac arrhythmias.
• Caution with exaggerated neurovegetative responses. • Patients with hysteria or phobia of electricity.
• Reduction of application times in endoprosthesis and osteosynthesis material.
• Possible side effects derived from the application: • It can rarely cause a feeling of slight dizziness.
• It can rarely cause restlessness at bedtime. • Rarely it can cause a slight increase in momentary pain. • Rarely it can produce edema or erythema.
• It can rarely cause microburns.
• It can rarely cause heartburn for a short time. • Rarely can cause skin itching.

*Safety and Use Measures

What you should never do with the NESA XSIGNAL®:

Do not use the NESA XSIGNAL® in water or in a humid place (sauna, hydrotherapy, etc.).

It is recommended that the first five minutes of stimulation should always be performed on a person in a sitting or lying position, legs raised, until any possible sensation of weakness or vagal reaction disappears.

• Do not use the NESA XSIGNAL® within 1.5 meters of a short wave device, a microwave or high frequency (AF) surgical equipment, as there is a risk of causing skin irritation or burns under the electrodes. If you have any questions about how to use the NESA XSIGNAL® series in close proximity to other medical devices or medical treatment, please consult the manufacturer or your physician.
• Do not disconnect the stimulator cables during a session while the device is still connected. You must first stop the stimulator.
• Never connect the stimulator cables to an external electrical source, because there is a risk of electric shock.
• Never use the NESA XSIGNAL® if it is damaged or if the body of the equipment is open. There is a risk of electric shock. • Keep the NESA XSIGNAL® and its accessories out of the reach of children.
• Do not allow any foreign body (earth, water, metal, etc.) to enter the NESA XSIGNAL®.
• A sudden change in temperature can affect the performance of the appliance due to condensation. Use the appliance without sudden changes in temperature.
• Do not place the NESA XSIGNAL® equipment in a position that makes it difficult to disconnect it from the power supply.
• Do not use the NESA XSIGNAL® while driving or working with machinery.

Where Electrodes (of any type) should never be applied

• Do not use the equipment on unhealthy or infectious skin.
• Do not use Electro-Supports on wounds or exposed tissue.
• Do not use on the head.
• Do not use on animals.
• Arbitrarily, consult the manual for the correct placement of the electrodes, consult NESA WORLD® in case of doubt.
• Use exclusively the electrodes and accessories provided by NESA XSIGNAL® series. Other electrodes may have inadequate electrical characteristics for the NESA XSIGNAL® series stimulator.
• Disconnect the device before removing or moving the electrodes during the session.
• Do not immerse electrodes in water.
• Do not pour any type of liquid.
• Do not apply any type of corrosive solvent to the electrodes and/or NS4 Series accessories, whatever the type.
• Pay attention not to “pinch” any cable and/or accessory when closing the equipment case. Breakages of accessories or cables of this type are not covered by the guarantee.
• The application of the electrodes above the heart can increase the risk of cardiac fibrillation.
• Before applying the electrodes, it is advisable to wash the skin and electrodes, removing traces of grease and sweat, then dry them.
• It is necessary to make sure that the entire contact surface of the electrodes is attached to the skin, avoid contact of the electrodes with the hair.
• For very important hygiene reasons, each user must have their own set of electrodes. Do not use the same electrodes with different people.
• Do not use the same or compatible set of dermal electrodes for more than 1 sessions, as the quality of contact between the electrodes and the skin – an important factor for comfort and stimulation efficacy – progressively deteriorates. It also loses adherence and if it comes off the skin, the system has no effect. Consult according to electrode models with NESA WORLD® in case of doubt.
• In some people with very sensitive skin, the appearance of red spots under the electrodes can be observed after a stimulation session. In general, these rednesses are completely benign and disappear in a short period of time. In any case, as long as they have not disappeared, another stimulation session will not be restarted.

*For private use of treatment, prior training is not necessary for the use of the NESA XSIGNAL® equipment, while the monthly clinical follow-up is carried out by a health professional who is an expert in the NESA non-invasive neuromodulation technique, read the manual carefully and consult your health professional.

Use and security measures

Consult according to electrode models with NESA WORLD® in case of doubt. In some people with very sensitive skin, after a neuromodulation session, the appearance of red spots under the electrodes can be observed. In general, these rednesses are completely benign and disappear in a short period of time. In any case, as long as they have not disappeared, another neuromodulation session will not be restarted.

Relative contraindication in cancer patients: what relativity does it refer to? when yes? when not? 

If there is medical authorization for the use of low frequency and intensity currents, it is not a contraindication

It is placed on the stretcher or seated connected with gloves and anklets with a connected electrode. The therapy is completely imperceptible, it usually lasts about 60 minutes.

Gloves and anklets must always be connected to the extension cables and the steering electrode connected to the steering cable that is also connected to the NESA XSIGNAL® technology.

Check if the gloves and anklets are correctly positioned with the references for right hand, left hand, right foot and left foot, and in the correct position.

RECOMMENDATIONS FOR TREATMENT

The NESA XSIGNAL® neuromodulation medical device is a non-invasive electrotherapy technique that is painless, imperceptible and comfortable to use.

Due to the use of electrical stimuli of low intensity and frequency, it is recommended, to maximize its efficiency, to follow the instructions below:

• Consider the treatment time as a time to relax and enjoy yourself.
• Do not use your mobile phone or any portable electronic device that could distract you or receive information from outside that could affect your state of relaxation.
• Use a book or any other non-electronic resource that allows you to relax.
• Listen to relaxing music with which you can enjoy this time dedicated to your recovery.
• Try to avoid wearing watches, pendants or any item of jewelry or wearing them as little as possible

NESA XSIGNAL® technology is used as a neuromodulator of the autonomic nervous system.

It is applied in two modalities, in active therapy (combining manual therapy, invasive neuromodulation, other techniques/technologies, etc.) and in passive therapy. (Only with the technology or combined with other techniques/technologies that work autonomously)

Passive Therapy:

The patient is placed on the stretcher with the device in place or in a comfortable place.

It is recommended for treatment:

1. a) Take an anamnesis that involves processes of the autonomic nervous system.
2. b) Objective evaluations of their autonomous nervous system that are useful for clinical follow-up. (Cortisol/amylase measurements, scientifically validated assessment tests, ANS electrocardiogram, use autonomous assessment devices at home as a baseline prior to starting treatment, etc.)
3. c) Remove metal from the hands and neck as much as possible. (Jewelry, necklaces, bracelets, watches, etc.)
4. d) Clean the placement area with alcohol and cotton (Feet, hands and placement area of the guiding electrode)
5. e) That he is supine or sitting in a comfortable place. f) Relax the popliteal area with a semi-curl or roller if it is on a stretcher.

g) We recommend covering the patient and dimming the light if possible.

Active Therapy:

It is recommended for treatment:

a) Take an anamnesis that involves processes of the autonomic nervous system.

b) Objective evaluations of their autonomous nervous system that are useful for clinical follow-up. (Cortisol/amylase measurements, scientifically validated assessment tests, ANS electrocardiogram, use autonomous assessment devices at home as a baseline prior to starting treatment, etc.)

c) Remove metal from the hands and neck as much as possible. (Jewelry, necklaces, bracelets, watches, etc.)

d) Clean the placement area and placement of the targeting electrodes with alcohol and cotton. (Feet, hands, and placement area of the targeting electrode or targeting electrode prior to the use of creams or anything that generates higher impedance)

e) That he is in supine ulna, prone ulna or in active exercise with minimal load.

f) Apply focal, metameric or central NESA® therapy during the combined approach process.

g) We recommend covering the patient and dimming the light if possible if he is going to be left in any active therapy process in passive therapy.

NESA XSIGNAL® healthcare technology cannot be combined with TENS electrotherapy techniques, nor with radiofrequency of any kind while using NESA® non-invasive neuromodulation.

Yes, PRE or POST NESA® treatment can be applied.

If you have any questions about technologies with which to combine NESA technology, please contact us at contact zone or if you are already a client through the NESA® team.

The shape of the impulse is a symmetrical biphasic current, where the positive and negative part have the same route on the abscissa axis, in this way, we would be talking about a current with addressability "0", and the shape of its impulse is rectangular. It also has a single phase component. The modulation is preset in the device. It is not modulated manually. The only thing that can be modulated is the voltage at 3V or 6V. It also allows the selection of different programs and application times, and all the impulses are coordinated with the directing electrode.

The application frequency is minimal, being considered a microcurrent. The determined frequency may be 1.12 or 14.28 Hertz.

The potential difference is so low that the application is located in areas of low impedance and at currents ranging between 0.1 and 0.9 ɱA, which is not developed in Ohm's law.

For more information visit: NESA microcurrents

All. It is the essence of the treatment, more than 15,000 low-frequency bioelectric impulses are coordinated per minute with the guiding electrode, in order to generate endogenous responses in the autonomic nervous system.

It is the essence of the treatment, if that essence is broken. It would no longer be NESA® non-invasive neuromodulation.

Yes, an informed consent signature is mandatory.

The areas chosen as the electrode point are due to the fact that the pioneering Japanese team of technology carried out trial-error studies to determine the areas of lower impedance where the nerves with sensitive branches would have greater exposure and thus ensure the entry of current with the lowest possible impedance through the skin.

Like any electrical current, NESA® neuromodulation generates an electrical circuit through the nerve pathways of the body, as if they were a highway, the directing electrode closes the circuit and at the same time helps to redirect the electrical flow transmitted by the other electrodes. For this reason it differs in its position depending on whether the treatment is central, metameric or focal.