Contraindications

The Nidra TOMAC System is contraindicated for use in patients with the following:

• Diagnosis of epilepsy or other seizure disorder
• Active medical device implant anywhere in the body, including but not limited to pacemakers, spinal cord stimulators, deep brain stimulators
• Metal implant in the leg at the therapy site (not including knee replacements)
• Known allergy to device materials (or severe previous reaction to medical adhesives or bandages)
• Cellulitis, open sores, or injury at or near the location of therapy device application
• The device cannot be used while driving, operating machinery, or during any activity in which electrical stimulation can put the patient at risk of injury

Potential Complications

There is a potential for the following side effects, which are typically mild to moderate and resolve over time:

• Mild skin irritation from use of adhesives.
• Temporary interference with sleep while wearing the device. For some people, the device may be uncomfortable. For others, the device may interfere with preferred sleep positions.
• Proper use of the device as described in the Instructions for Use (IFU) can help reduce or prevent the following complications: Discomfort, paresthesia (tingling or prickling sensation), or otherwise irritating or uncomfortable sensations during treatment. This risk is reduced by adjusting the stimulation intensity.

This list is not all inclusive. Please refer to the Instructions for Use for all of the important warnings and precautions before using or prescribing this product.