This section lists general Warnings and Cautions related to using Cala Trio.

Warnings

• To avoid the risk of electric shock, burns, electrical interference, or death, do not use Cala Trio if you have:
  • A pacemaker
  • An implanted defibrillator
  • Other implanted electronic devices, or implanted metal in the wrist
• Do not use Cala Trio while:
  • Sleeping
  • Driving
  • Bathing
  • Operating machinery
  • Doing any activity in which possible involuntary muscle contractions due to therapy may cause undue risk of injury.
• Do not use Cala Trio:
  • Near the head
  • Directly on the eyes
  • Covering the mouth
  • On your upper back
  • Over the heart area
  • On diseased skin
• Do not use Cala Trio on the neck.
  • Doing so can cause severe muscle spasm, resulting in closure of the airway, difficulty with breathing, or adverse effects on heart rhythm.
• Do not use Cala Trio on the chest.
  • Introduction of electric current into the chest may cause rhythm disturbances to the heart, which could cause death.
• Do not apply Cala Trio near the chest.
  • This may increase the risk of abnormal heart rhythm (arrhythmia).
• Do not apply Cala Trio over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins, etc.).
• Do not apply Cala Trio over—or in proximity to—cancerous lesions.
• To prevent electrical shock, do not immerse Cala Trio in water.
• Do not wear Cala Trio while performing activities where Cala Trio is under water (e.g., swimming or bathing).
• Do not use Cala Trio simultaneously with:
  • High-frequency surgical equipment, as this may result in electrical burns and/or possible damage to Cala Trio
  • Electronic- monitoring equipment (e.g., cardiac monitors, ECG alarms), which may not operate properly when Cala Trio is in use
• To prevent an explosion hazard and possible injury, stop Cala Trio therapy when at a refueling place (e.g., gas station).
• Do not use Cala Trio near flammable fuel, fumes, or chemicals.
• Physician approval should be obtained by your prescribing physician before using Cala Trio if you have any implanted devices at the site of stimulation.
• Cala Trio provides chronic electrical stimulation, the long-term effects of which are unknown.
• To prevent uncomfortable therapy, skin irritation and/or shock, the user should wet their wrist before donning Cala Trio.
• Therapy at an intensity that is too high can cause discomfort in your wrist and/or hand, muscle contraction, or skin irritation.
• Some may experience skin irritation, an allergic reaction, or hypersensitivity to the therapy or the band.
• Avoid removing Cala Trio from your wrist during therapy.
• To charge Cala Trio, use only the Cala Trio Base Station.
• The cord on the charger may present a choking hazard. Keep away from children.