6
Questions about Cala Trio? Visit CalaTrio.com/HCPFAQs
LBL-5122 Rev C NOV 2019
electrical stimulation burns of the skin, which may cause
focal pinpoint edema, erosion and crusting.
•
Store the device to prevent exposure to dust, direct
sunlight, and pests. It is recommended to store the
device in the original packaging when not in use or
being charged.
•
To prevent damage to the device and/or
performance issues:
»
Keep the device dry. Cala Trio can withstand some
splashing.
»
Avoid the formation of condensation on the device.
When moving the device between hot and cold
temperatures, place it in an airtight plastic bag and let
it slowly adjust to the temperature change before use.
»
Do not use the device in places with high humidity,
such as the bathroom.
»
Do not store or transport the device or its accessories
in temperatures that exceed the recommended
storage temperature range: -20°C to 45°C
(-4°F to
113°F)
. Do not operate the device in temperatures
that exceed the recommended operation temperature
range of 5°C to 40°C
(41°F to 104°F)
. Temperature
extremes can damage the device and accessories.
»
Do not tamper with, modify, or attempt to perform
maintenance or servicing on the device.
»
Do not use the device
within 3 1/2 feet
(e.g., within 1
meter)
of shortwave or microwave therapy equipment.
•
To prevent damage, performance issues, increased
emissions, or decreased immunity of the device only
use the accessories recommended by Cala Health
with the device. The device claims compliance for
electromagnetic compatibility levels in conjunction
with the charger
(see Section 11)
.
•
Advise patients to use the device with caution:
»
If the patient has a tendency to bleed following
an injury.
»
Over areas of the skin that lack normal sensation.
•
Keep out of the reach of children and pets.
•
The device is single-patient use by the individual for
whom it has been prescribed. It should not be worn by
anyone else or on any other part of the body.
•
To avoid interfering with diagnostic assessments,
advise the patient to not wear the device during x-ray
examinations.
•
Should any technical problem occur that is not covered
in the Healthcare Professional Guide or the Patient
Guide, please contact Cala Health at 888-699-1009 or
CustomerSuccess@CalaTrio.com.
3.4 Adverse Reactions
The following are possible minor/moderate risks or adverse
reactions that may occur with the use of the device:
•
Discomfort with stimulation
(e.g. stinging, sensation of
weakness, etc.).
•
Allergic reaction to electrodes or other materials.
•
Skin irritation, including electrical stimulation burns,
redness and/or itching.
In the unlikely event that any of the following more
significant issues occur, advise the patient to stop using
the device immediately and to consult a physician:
•
Signs of significant and persistent skin irritation, sores,
electrical stimulation burns or lesions at the site of
stimulation.
•
Significant and persistent increase in muscle tightness
or stiffness.
•
A feeling of chest pressure during stimulation.
•
Swelling of the arm, wrist, or hand.
3.5 Skin Care Guidelines
The device works by electrically stimulating nerves
through the skin. It is important for the patient to
inspect their skin where it contacts the electrodes to
minimize risk of skin irritation. To promote good
electrode connection and healthy skin, instruct the
patient to follow these skin care guidelines:
•
Wet your wrist before donning Cala Trio.
•
If there is any excess oil or lotion on your wrist, wash
with soap and water and rinse well before wearing
Cala Trio.
•
Always check the skin for irritation, redness, or rash
when putting on and taking off Cala Trio.
