9
LBL-5117 Rev C AUG 2019
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 inlamed 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 lammable 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
