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Questions about Cala Trio? Visit CalaTrio.com/HCPFAQs
LBL-5122 Rev C NOV 2019
This section lists Contraindications and general Warnings,
and Cautions related to the use of Cala Trio therapy. Those
Warnings and Cautions pertaining to specific functions or
procedures are included throughout this Guide.
3.1 Contraindications
The device should
NOT
be used:
»
by patients with an implanted electrical medical
device, such as a pacemaker, defibrillator, or deep
brain stimulator.
»
by patients that have suspected or diagnosed epilepsy
or other seizure disorder.
»
by patients who are pregnant.
»
on swollen, infected, inflamed areas, or skin eruptions,
open wounds, or cancerous lesions.
3.2 Warnings
•
Do not use this device on patients who have a cardiac
pacemaker, implanted defibrillator, or other implanted
electronic device, or implanted metal in the wrist,
because this may cause electric shock, burns, electrical
interference, or death.
•
Do not use the device while sleeping, driving, bathing,
operating machinery, or during any activity in which
possible involuntary muscle contractions due to
stimulation may cause undue risk of injury.
•
Do not use the device near the head, directly on the
eyes, covering the mouth, upper back, crossing over
the heart, or on diseased skin.
•
Do not use the device on the neck because this could
cause severe muscle spasm resulting in closure of the
airway, difficulty in breathing, or adverse effects on
heart rhythm.
•
Do not use the device on the chest because
introduction of electric current into the chest may
cause rhythm disturbances to the patient’s heart,
which could cause death.
•
Do not apply the device near the thorax, as this may
increase the risk of arrhythmia.
•
Do not apply stimulation 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 stimulation over, or in proximity to,
cancerous lesions.
•
To prevent electrical shock, do not immerse the device
in water or wear while performing activities where the
device is under water, such as swimming or bathing.
•
Do not use the device simultaneously with:
»
high frequency surgical equipment, as this may
result in electrical burns and/or possible damage
to the device.
»
electronic monitoring equipment
(e.g., cardiac
monitors, ECG alarms)
, which may not operate
properly when the electrical stimulation device
is in use.
•
To prevent an explosion hazard and possible patient
injury, instruct the patient to stop stimulation
from the device when at a refueling place
(e.g., gas
station)
. Do not use the device near flammable fuel,
fumes, or chemicals.
•
Implanting-physician approval should be obtained by
the prescribing physician before using on patients with
implanted devices at the site of stimulation. Use of
the device with some implants is contraindicated – see
Contraindications for details.
•
The long-term effects of chronic electrical stimulation
are unknown.
3.3 Cautions
•
The device has only been evaluated in subjects
diagnosed with essential tremor and the effectiveness
of the device has not been evaluated for tremor
associated with other conditions.
•
Do not use Cala Trio if you have suspected or diagnosed
epilepsy or other seizure disorder.
•
Use the device only as directed by the Health Care
Professional Guide and the Patient Guide.
•
The safety of electrical stimulation during pregnancy
has not been established.
•
Higher stimulation levels may be associated with
potential for increase in skin irritation, including
SAFETY INFORMATION
3.0
