Additional safety information

Contraindications, warnings & Precautions

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The Proliv™Rx System is contraindicated for use in patients with:

• A history of intracranial surgery.
• Recent traumatic brain injury (TBI) (less than three months).
• A metal implant or shrapnel in their head, except for dental implants.
• An implanted neurostimulator or electronic device in your head such as a cochlear implant or brain pacemaker.
• A cardiac pacemaker or an implanted or wearable defibrillator.
• Skin lesions, scars, or inflammation at the region of the stimulating electrodes.

Warnings

• The Proliv™Rx does not represent a substitution for your medication.
• Apply treatment only to intact, clean, healthy skin.
• Do not use the device on any other areas apart from the head.
• Keep the device out of reach of children. Small parts, such as the disposable pads, may be a choking hazard for small children
• 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 in the presence of electronic monitoring equipment that may not operate properly when the electrical stimulation device is in use.
• Do not use a device that shows signs of mechanical damage or loose parts.
• Do not modify this device or its accessories.
• Do not connect the Proliv™Rx device with other equipment.
• Use this device only with the supplied charger.
• Do not use any accessories, electrode pads, detachable parts, and materials that are not provided or recommended by Neurolief.
• Patients with active suicidal intent or plan should follow physician’s/psychiatrist’s instructions.
• If depression symptoms worsen, contact your physician.
• This device should only be used by patients whose clinical course is supervised by a medical

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.
• 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.
• Do not use the device in the bath or shower.
• If the device does not function as described in this manual, stop using it and contact customer support.
• The Proliv™Rx device is designed for use by and on a single adult person. For hygiene reasons, the device should not be shared.
• Keep the device out of reach of pets.
• It is recommended that your mobile device be protected by a password (or other security mechanisms) to prevent unauthorized access to the Proliv™Rx device.

Adverse reactions

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Proliv™Rx, along with similar antidepressant treatments, have the potential for certain adverse reactions, which are detailed below. Adverse reactions reported with Proliv™Rx have been demonstrated in clinical trials to be mild to moderate and most are fully reversible upon cessation of device use. If adverse reactions persist, stop using the device and consult your physician/psychiatrist.

• Unpleasant sensation during treatment (e.g., pressure sensation at the stimulation position).
• A sensation of scalp numbness (paresthesia) during and after treatment.
• Persistent tingling, stinging, itching, or burning sensation after the treatment ends.
• Pain or discomfort.
• Skin reaction (e.g., irritation, lesion, or burn) beneath the electrodes. In such cases, 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
• Depression-related adverse events:
  • Mania
  • Suicidal ideation
  • Worsening depression