VitaliTENS connected electrostimulator

Technology based on the production of a low voltage electric current transmitted to the nerves by electrodes placed on the skin.

General characteristics:
• Discreet and easy to use device
• Small, light and flexible, it is controlled via a smartphone

Supplied in the box:
• VitaliTENS neurostimulator.
• Charging box.
• Food.
• Cuff (standard size).
• Pack of 2 medium cables (40 cm).
• Pack of 2 small cables (14 cm).
• Mixed electrode pack, 2 squares and 2 rectangles.
• Notice.
• Quick Start Guide.

Contraindications
VitaliTENS should not be used on the following patients without medical advice:
• Patients with pacemakers, intracardiac defibrillators or other similar active implantable devices.
• Patients with heart problems.
• Epileptic patients.
• Patients with decreased or altered sensation or sensitivity in the area to be treated, for example patients with allodynia (pain triggered by a stimulus that is normally painless) in the area to be treated.
• VitaliTENS should not be used on pregnant women without medical advice. The electrodes should not be placed on the abdomen of pregnant women.

Failure to comply with contraindications may lead to serious consequences and be detrimental to the patient.

Risks and unwanted side effects:
• The use of VitaliTENS may in some cases cause hyperalgesia (abnormally amplified pain caused by a painful stimulus). If this occurs, we recommend that you stop using the device and consult a healthcare professional.
• Use of the neurostimulator may cause erythema (redness), skin irritation, inflammation, allergy or burns in the area where the electrodes are placed or in the area where the textile accessories are attached. In the event of skin irritation after stimulation, it is preferable to temporarily interrupt the treatment and consult a healthcare professional.
• Partial detachment of the electrodes may cause a slight electric shock. Be sure to change your electrodes regularly to limit detachment (see section 20 of the full instructions).
• Use of VitaliTENS may cause temporary muscle pain or involuntary muscle contractions. It is recommended to consult a healthcare professional before using the device.
• Certain accessories (cables, power supplies and textile accessories) may present a risk of strangulation.

Warnings:
• Keep out of reach of children, animals and people with reduced intellectual capacity.
• Do not position the electrodes and neurostimulator on the front of the neck (especially the carotid sinus) as this may cause adverse effects on heart rate or blood pressure or cause severe muscle spasms resulting in the closure of your airways or difficulty breathing.
• Do not place the electrodes on the chest or on either side of the heart. Applying electrodes close to the chest may increase the risk of cardiac fibrillation.
• Do not use the neurostimulator for transcranial stimulation (electrodes on either side of the head), as the effects on the brain are unknown.
• Electrodes should not be placed directly on the spine.
• Electrodes should not be applied to a pathological limb (active phlebitis).
• Do not use the neurostimulator while the patient is connected to high-frequency surgical equipment (e.g., electric scalpel). Simultaneous use may cause burns under the electrodes and the neurostimulator may be damaged.
• Never place the electrodes inside body cavities. This device is designed for external application. Do not apply stimulation directly to the eyes or mouth.
• For hygiene reasons, the electrodes can only be used by one and the same patient.
• Do not attempt to open or modify the VitaliTENS neurostimulator and the charging box as this may cause electrical hazards.
• Do not use the neurostimulator and the charging case in the immediate vicinity (e.g. 1 m) of shortwave or microwave devices. The nominal power of the device may be affected, which may cause painful reactions.
• Do not use the VitaliTENS neurostimulator and the charging case near electronic monitoring equipment (e.g. heart monitors, ECG, EEG), as there is a risk that they may not function properly while the neurostimulator is in use.
• Keep the neurostimulator and charging case away from water or any other liquid, as this may cause unpredictable current flows and damage the product.
• Do not use the device in an explosive environment (e.g. gas station).
• Do not use the VitaliTENS device in emergency medical services.
• We recommend not using the VitaliTENS neurostimulator while driving a vehicle or handling dangerous equipment (saw, lawnmower, etc.) because of the risk of uncontrolled muscle contractions if the intensity is too high. An accidental change in stimulation could distract attention and cause a dangerous situation.
• We recommend not using the VitaliTENS neurostimulator during sleep phases; pain may be felt too late.
• Precautions should be taken in patients suffering from mental disorders or electrophobia.
• Do not use several VitaliTENS simultaneously on the same person.

Directions for use:
• The neurostimulator must only be used with accessories from the VitaliTENS range. The use of other accessories may result in faulty operation.

• Precautions regarding electrodes used with VitaliTENS:
- Do not place the electrodes on damaged, irritated skin, especially on an open wound or near cancerous lesions.
- If redness or skin irritation occurs, remove the device. Irritation usually disappears after a few hours. If irritation persists, consult a healthcare professional.
- Always place the electrodes on clean, dry skin.
- Before removing the electrodes from the skin, turn off the neurostimulator by stopping the stimulation session from the application or by pressing the ON/OFF button.
- If an electrode becomes detached, turn off or pause the neurostimulator before touching the electrode. The current pulses from the neurostimulator on the fingers are unpleasant but do not pose any danger. Refer to section 15 of the full instructions "Stopping the stimulation session".
- Do not overlap the electrodes.
- It is recommended not to use conductive gel with the electrodes.

• Precautions for using textile accessories with VitaliTENS:
- Do not place these accessories on damaged, irritated skin, especially on an open wound.
- If redness or skin irritation occurs, remove the device. If irritation persists, consult a healthcare professional.
- It is recommended not to tighten the cuff too much so as not to interrupt blood circulation in the affected limb.

• Avoid pulling on the cable wire to disconnect it from the electrode and the VitaliTENS so as not to damage it.
• Do not use the VitaliTENS neurostimulator during physical activities with a risk of shocks or impacts to avoid the risk of damaging the device.
• If the VitaliTENS neurostimulator or the charging case is dropped, check the condition of the device before using it again. If the device is damaged, there is a risk of electric shock during use.
• Do not use VitaliTENS and its accessories if they are not working properly or if any part is damaged. Always check the integrity and proper functioning of the system before using it.
• The VitaliTENS neurostimulator must be recharged indoors at room temperature.
• The VitaliTENS neurostimulator must only be recharged with the power cable supplied with the device.
• When charging the device, ensure that the mains plug of the power supply remains accessible so that the device can be quickly disconnected from the mains if necessary.
• Do not store the VitaliTENS neurostimulator for a long time without using it to avoid deep discharge of the batteries.
• It is recommended to lock the phone (manually or automatically) after initiating a stimulation or when not in use and to require security when unlocking it.

DM Class IIa
Weight: 65 g
Warranty: 2 years