Important Information for Physicians About Relaxis

 

Indications for Use: The purpose of the Relaxis device is to improve the quality of sleep in patients with primary Restless Legs Syndrome (RLS) through the use of vibratory counterstimulation.

Contraindications: This device should not be used by patients who have been diagnosed with deep venous thrombosis (DVT) in either leg during the last 6 months because of the known potential to dislodge or break up the clot.

Adverse Effects: Relaxis may cause temporary worsening of symptoms, leg cramping, tingling, soreness, pain, and motion sickness. All adverse effects observed to date have resolved on their own after discontinuing use of the device.

Limitations: For prescription use only.

Warnings & Cautions:

  • Relaxis is only intended for use by patients with primary Restless Legs Syndrome (RLS). It is not intended for use by people who have:
    • Leg skin disorders such as eczema, psoriasis, cellulitis, non-healing wounds; or
    • Secondary RLS.
  • Patients should be screened for secondary RLS caused by iron deficiency anemia, back pain, kidney failure, diabetes, peripheral neuropathy (numbness or tingling in hands or feet), or pregnancy.
  • Relaxis has not been tested on people who take drugs that may cause RLS or RLS symptoms. Safety and effectiveness have not been established in these people.
  • You should be able to remove Relaxis if necessary.
  • Patients should only apply Relaxis to normal, intact, clean, healthy skin.
  • The Relaxis pad and controller will become warmer during use. Patients should stop use of Relaxis if the heat causes discomfort or pain.
  • Relaxis consists of cotton (outer pad cover), polyvinyl chloride (inner pad cover), polyurethane foam (internal pad), acrylonitrile butadiene styrene and polyester plastic (controller). People with known allergic reactions to these materials should not use Relaxis. Advise patients to contact you if a skin reaction occurs after using Relaxis.
  • Patients should stop using Relaxis and contact their doctor if their RLS symptoms worsen.
  • Patients should not initiate more than two back-to-back 35-minute therapy cycles.
  • Patients should only apply Relaxis as needed. Too much stimulation may lead to discomfort.
  • Patients should not use Relaxis in moist, wet, or dusty areas. This may increase the risk of electrical shock and failure.
  • Patients should not use Relaxis in oxygen rich areas.