Indication: The Relivion® MG is indicated for the acute treatment of migraine with or without aura in patients 18 years of age or older. It is a prescription device to be self-used at home.
Contraindications
- Subjects with a metal implant or shrapnel in their head, except for dental implants, should not use the device.
- Subjects with recent (less than three months) brain or facial trauma should not use the device.
- Subjects with skin abrasions on the forehead or occiput at the contact area of the Relivion MG should not use the device.
- Subjects with implanted neurostimulators or any implanted metallic or electronic device in the head, a cardiac pacemaker or an implanted or wearable defibrillator should not use the device.
Warnings
- Do not use the device while driving or in conjunction with dangerous activity during which the user must be alert and focused (for example, while operating machinery).
- Do not use the device on any other areas apart from the head.
- Do not use the device in the bath or shower.
- Do not use the device while sleeping.
- Do not use the device in the presence of electronic monitoring equipment (e.g., cardiac monitors, ECG alarms) that may not operate properly when the electrical stimulation device is in use.
- Apply treatment only to intact, clean and healthy skin.
- Do not use this device in locations subject to extreme high or low temperatures or humidity. Use within the temperature and humidity range according to the product’s specifications (see Table 6).
- Do not use a device that shows signs of mechanical damage or loose parts.
- No modification of this equipment is allowed.
- Do not interconnect the Relivion MG device with other equipment.
Precautions
- The long-term effects of chronic use of the device are unknown.
- The safety of electrical stimulation during pregnancy has not been established.
- Patients with suspected or diagnosed heart disease should follow precautions recommended by their physicians.
- Patients with suspected or diagnosed epilepsy should follow precautions recommended by their physicians.
- Keep the device out of reach of children. Small parts, such as the disposable pads, may be a choking hazard for small children.
- Use this device only with Neurolief electrode pads and the Neurolief power supply and charging cable supplied with the device. Do not use any accessories, detachable parts and materials that are not provided by Neurolief.
- The Relivion® MG device is designed for use by and on a single adult person. For hygiene reasons, the device should not be shared.
If the device does not function as described in this user manual, stop using it and contact Customer Care.
Adverse Reactions
Relivion has few reported adverse reactions, which have been demonstrated in clinical trials to be minor and fully reversible with cessation of device use. If adverse reactions persist, stop using the device and consult your physician.
- Unpleasant sensation during treatment (for example Pressure sensation on the stimulation position).
- Scalp numbness sensation during and after treatment (Paresthesia).
- Persistent tingling sensation after the treatment ends.
- Pain.
- Nausea.
- Skin reaction (for example irritation, lesion, burn) beneath the electrodes. In this case, treatment should be temporarily discontinued.
- Redness of the skin under or around the electrodes. Skin redness usually disappears within several hours after treatment.
- Sleepiness (Somnolence), fatigue, or disruption in sleep patterns. Sedative effect during or after treatment.
- Dizziness during or after treatment.
- Headache/migraine.
Use the Relivion MG only with Neurolief electrode pads, the Neurolief power supply and charging cable supplied with the device. Do not use any accessories, detachable parts and materials that are not provided by Neurolief. If the device does not function as described in the user manual, stop using it and contact customer support. The Relivion MG device is designed for use by and on a single adult person. For hygiene reasons, the device should not be shared.
