Cala Health Trio User manual

PATIENT GUIDE
Caution: Federal law restricts this device to sale by or on the order of a physician LBL-5117 Rev C AUG 2019

Manufactured by Cala Health, Inc.
875 Mahler Road, Suite 168
Burlingame, CA 94010
888-699-1009
www.CalaHealth.com
Copyright (c) 2018, Cala Health, Inc. All Rights Reserved.
Cala Health, Cala, and Cala Trio are trademarks of Cala
Health, Inc., registered in the U.S. and other countries.
Patent: CalaTrio.com/Patents
Model: CTS100, CTB101, CTB102, CTB103, CTB104,
CTB105, CTB106

TABLE OF CONTENTS
1.0 List of Symbols.....................................................................4
2.0 Introducing Cala Trio...........................................................6
2.1 Indications for Use ................................................................. 6
2.2 Cala Trio Therapy Components ......................................... 7
3.0 Safety Information............................................................. 8
3.1 Warnings................................................................................... 8
3.2 Cautions ................................................................................ 10
3.3 Adverse Reactions ................................................................ 11
4.0 Setting Up Cala Trio .......................................................... 12
4.1 Positioning and Fastening Cala Trio .................................12
4.2 Calibrating Cala Trio.............................................................14
4.3 Setting Therapy Intensity....................................................16
5.0 A Therapy Session with Cala Trio .................................... 19
5.1 How to Stop Cala Trio Therapy .......................................21
5.2 How to Rate Your Tremor with Cala Trio .......................21
5.3 How to Remove Cala Trio ................................................... 22
6.0 Caring for Cala Trio .......................................................... 23
6.1 How to Charge Cala Trio .................................................... 23
6.2 How to Replace Cala Trio Band......................................... 24
6.3 How to Change Stimulation Intensity Preset................ 24
6.4 How to Reset Cala Trio........................................................ 25
6.5 How to Clean and Store Cala Trio .................................... 25
7.0 Troubleshooting ................................................................ 26
8.0 Clinical Study Summary .................................................. 29
9.0 Technical Speciications.................................................... 31
10.0 Electromagnetic Compatibility Declaration .................. 33
11.0 Warranty Information....................................................... 40
LBL-5117 Rev C AUG 2019

4Questions about Cala Trio? Visit CalaTrio.com/FAQs
LIST OF SYMBOLS
Caution
Refer to instructions for use.
Contains electronic equipment Properly
dispose in accordance with local regulations.
Complies with United States Product
Safety Standards.
Sold by prescription only. Caution: Federal
law restricts this device to sale by or on
the order of a physician.
Type BF Applied Part(s)
Manufacturer
Date of manufacture
Use by date
1.0

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Cala Trio is rated for these atmospheric
pressure limits. For more information on
environmental parameters, refer to the
Technical Speciications in this User Guide.
Serial number
Catalogue number
Batch code
Class II Equipment
Protected against intrusion from ingers
and small objects, and from water drops
vertically falling on Cala Trio when it is
tilted up to 15  from vertical. Do not immerse
in a bathtub or use while swimming.
Cala Trio is rated for these temperature
limits. For more information on environmental
parameters, refer to the Technical
Speciications in this User Guide.
Cala Trio is rated for these humidity limits.
For more information on environmental
parameters, refer to the Technical
Speciications in this User Guide.
IP22
40°C
104°F
5°C
41°F
70kPa
101kPa
90%
0%

6Questions about Cala Trio? Visit CalaTrio.com/FAQs
2.0
INTRODUCING Cala Trio
View instructional videos at my.CalaTrio.com
2.1 Indications for Use
Cala Trio is indicated to aid in the transient relief of hand
tremors in the treated hand following stimulation in adults
with essential tremor (ET).
• Cala Trio is a non-invasive, wrist-worn device for adults
with essential tremor.
• Meaningful relief is usually observed after use.
• Electrodes embedded in a cloth band (Cala Trio Band),
deliver therapy to nerves in the wrist.
• Cala Trio therapy is delivered during 40-minute
stimulation sessions, which can be started and stopped
on demand.
• Cala Trio therapy should be applied when transient relief
of hand tremor is desired (i.e. before activities involving your
hands such as meals or writing).
• Cala Trio therapy is recommended for use at least twice
daily to help with the activities listed above.

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2.2 Cala Trio Therapy Components
Your Cala Trio Therapy System contains the following:
Cala Trio Stimulator
• Snaps into the Cala Trio Band
• Is worn around your wrist like a wristwatch secured with
the Cala Trio Band
• Is worn on the wrist of the prescribed hand
Cala Trio Band
• Contains electrodes
• Delivers therapy to nerves in your wrist
• Designed for either right- or left-handed use
• Needs to be replaced to maintain effective therapy
delivery
Cala Trio Base Station
• AC-powered base station in which Cala Trio
sits for recharging
Base
Station
Band
Cala Trio
Stimulator

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This section lists general Warnings and Cautions related to
using Cala Trio.
3.1 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 deibrillator
»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, dificulty with breathing, or
3.0
SAFETY INFORMATION

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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 inlamed 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

10 Questions about Cala Trio? Visit CalaTrio.com/FAQs
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.
3.2 Cautions
• Use Cala Trio only as directed by this Patient Guide or
your physician.
• Do not use Cala Trio if you have suspected or diagnosed
epilepsy or other seizure disorder.
• Do not use Cala Trio if you are pregnant.
• Higher stimulation levels may be associated with
potential for increase in skin irritation, including electrical
stimulation burns of the skin, which may cause focal
pinpoint edema, erosion and crusting.
• Store Cala Trio in the included microiber bag to prevent
exposure to dust and pests.
• To prevent damage and/or performance issues to Cala Trio:
»Keep Cala Trio dry. Cala Trio can withstand
some splashing.
»Do not use in places with high humidity
(e.g., the bathroom).
»Do not store or transport Cala Trio 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 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 Cala Trio.
»Do not use Cala Trio within 3 ½ feet of shortwave or
microwave equipment.
• To prevent damage, performance issues, increased

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emissions, or decreased immunity of Cala Trio, only use
the accessories recommended by Cala Health with the
device.
• Use Cala Trio with caution:
»If you tend to bleed following an injury.
»Over areas of the skin that lack normal sensation.
• Keep out of the reach of children and pets.
• Cala Trio 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 your body.
• To avoid interfering with diagnostic assessments, do not
wear Cala Trio during x-ray examinations.
• To prevent Cala Trio band damage, do not pinch, pull, or
twist the Band with too much force.
• Should any technical problem occur that is not covered
in the Patient Guide, please contact Cala Health at
888-699-1009 or [e-mail]
3.3 Adverse Reactions
The following are possible minor/moderate risks or adverse
reactions that you may experience with the use of Cala Trio:
• 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
signiicant issues happen, immediately stop using Cala Trio
and contact your physician.
• Signs of signiicant and persistent skin irritation, sores,
electrical stimulation burns, or lesions at the site of
stimulation
• Signiicant and persistent increase in muscle
tightness or stiffness
• A feeling of chest pressure during stimulation
• Swelling of your arm, wrist, or hand

12 Questions about Cala Trio? Visit CalaTrio.com/FAQs
4.0
SETTING UP Cala Trio
View instructional videos at my.CalaTrio.com
Setting up Cala Trio is as simple as 1, 2, 3...
1. Positioning and fastening it on your wrist
2. Calibrating
3. Setting therapy intensity
4.1 Positioning and Fastening Cala Trio
Positioning and fastening Cala Trio on your wrist correctly
is important to therapy success.
• Check your delivery ticket to verify the size and
handedness of the band.
• It is essential that the Cala Trio Stimulator and Band be
snapped together correctly. If they become detached,
align the half circle cut outs on the back of the stimulator
and band as you attach them together.
Step 1: Dampen entire wrist circumference with ample
amounts of water before positioning Cala Trio

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Step 2: Insert your prescribed hand through the band
making sure the MAIN button points toward the
elbow—not the hand
Step 3: Center the stimulator on the back of your wrist—as
close to the hand as possible without hindering
wrist movement
• This ensures a good connection between the electrodes
and wrist.
• Never submerge Cala Trio in water.
• If there is any excess oil or lotion on your wrist, wash with
soap and water and rinse well before wearing Cala Trio.
Note: Correct placement of the Cala Trio Band electrodes is
essential to therapy success.
Step 4: Ensure that the blue mark on the band is aligned
with the center of the inside of your wrist and
that the white mark is in line with your thumb.
Reposition if necessary

14 Questions about Cala Trio? Visit CalaTrio.com/FAQs
4.2 Calibrating Cala Trio
During stimulator setup, Cala Trio learns about your tremor
and personalizes therapy according to its characteristics.
• Calibration happens over the course of three
measurements taken while you perform the "Tremor
Task" prescribed by your physician.
Your "Tremor Task" can be found in your prescription
information or at my.CalaTrio.com.
Note: In order to conserve battery, Cala Trio goes into
SLEEP mode and fades to black if you are not actively
pressing any buttons. Press any button to wake
up Cala Trio.
Step 1: Press the MAIN button to wake up the stimulator.
You should see Cala Trio displayed
Step 5: Pull the end of the Cala Trio Band to tighten—fasten
the Velcro securely and tightly
• Should be snug enough so it does not slide along or around
the wrist.
• The electrodes should be lush to the skin.
UP button
DOWN button
MAIN button
Before calibrating, determine your "Tremor Task" by
checking your prescription information.

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Step 2: From Cala Trio, press and hold the MAIN button for 3
seconds to start setup. You will see "press main to
measure 1"
Step 3: Get in position to do your "Tremor Task" (see left)
You can ind your "Tremor Task" in your prescription
information or at my.CalaTrio.com
OR
Outstretched
postural hold
Wing-beating
postural hold
Step 5: Perform your “Tremor Task” until all dots are blue
(~20 seconds). Cala Trio will vibrate when the
“Tremor Task” is complete
Step 4: Press the MAIN button to start the measurement

16 Questions about Cala Trio? Visit CalaTrio.com/FAQs
Step 6: If you correctly performed your "Tremor Task" for
the full measurement, press the MAIN button to
save the measurement
Note: If you were moving in a way unrelated to your tremor
during the "Tremor Task", like walking or talking, press the
DOWN button and then the MAIN button to remeasure.
Step 7: Once Measure 1 is saved, Cala Trio will prompt you
for Measures 2 and 3
• Repeat the same process for Measures 2 and 3.
Note: If you accidentally save a poor measurement (e.g. you
were walking or talking during the "Tremor Task"), reset
Cala Trio by pressing and holding the UP and MAIN buttons
simultaneously for 3 seconds.
4.3 Setting Stimulation Intensity for Therapy
After calibrating Cala Trio to your tremor, you will set the
stimulation intensity preset.
• Cala Trio automatically ramps to the intensity preset
during all subsequent therapies.
• It is important to ind the maximum level of therapy that
you can comfortably tolerate for 40 minutes.
Note: You will always be able to increase or decrease the
intensity during therapy sessions as needed.
Reminder: Ensure you have dampened the entire
circumference of your wrist with ample amounts of water
before setting stimulation intensity.

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Step 2: Press the UP button to slowly increase intensity.
You may not feel the sensation right away
Step 3: As you continue to press the UP button, you should
feel a tingling sensation in your hand and ingers in
the areas highlighted in the images above
UP button
To set the intensity:
Step 1: Press the MAIN button from "press main to set
intensity". Wait 3 seconds before moving to step 2

18 Questions about Cala Trio? Visit CalaTrio.com/FAQs
Step 5: Press the MAIN button to save the intensity preset
Your Cala Trio therapy is personalized and ready to use!
Step 4: Once you ind the highest intensity level that you can
comfortably tolerate for a 40-minute therapy session, press the
MAIN button to stop stimulation
Note: Choose an intensity below a level that causes
discomfort or muscle contraction.
Note: Tingling sensation varies depending on Cala Trio
positioning and amount of water on the wrist.
»You may feel a stinging sensation if you did not wet your
wrist suficiently before fastening Cala Trio. See the
note below to add more water.
»You should not feel the tingling sensation in your pinky.
Additionally, if you do not feel the tingling sensation in
the ingers highlighted in step 3, see the note below to
reposition Cala Trio.
If needed, to add more water and reposition Cala Trio:
»Press the MAIN button and wait for therapy to stop
»Press the DOWN button to highlight 'reset intensity'
and the MAIN button to select
»Add water to your wrist (see section 4.1, page 12) or
adjust the placement of the band (see section 4.1, step 3,
page 13)
»Repeat steps 1-3 when you are ready to set your
intensity again (see section 4.3, pages 16-18)

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5.0
A THERAPY SESSION WITH Cala Trio
View instructional videos at my.CalaTrio.com
Step 1: To start a therapy session, from the time display,
press the MAIN button. You will now see "start
session"
Step 2: Press the MAIN button again to start a session
Note: "Tremor Task" measurements will be prompted
Step 3: If prompted, press the MAIN button to do your
prescribed ”Tremor Task”, or if you would like to skip
and are given the option, press the DOWN button
and then MAIN to skip until next session
Step 4: If prompted, do your "Tremor Task" (i.e., outstretched
postural hold or wing-beating postural hold)
To complete your "Tremor Task"
• You can ind your "Tremor Task" in your prescription
information or at my.CalaTrio.com.
• Get in position to do your "Tremor Task".
• Press the MAIN button to start the measurement.
A therapy session with Cala Trio is easy to start and it
into your day.
periodically before and after therapy sessions. Cala Trio
will prompt you in a similar way as described in section 4.2,
steps 3-5, on page 15.
UP button
DOWN button MAIN button

20 Questions about Cala Trio? Visit CalaTrio.com/FAQs
Note: Once therapy starts, it automatically ramps to your
intensity preset while displaying "starting therapy." Therapy
is then 40 minutes of stimulation.
Note: The "tingling" sensation of stimulation will naturally
vary from day to day. You can adjust the intensity as
needed to maintain a consistent sensation during therapy
and across sessions.
»To stop the ramp to your preset, press any button.
»Press the UP button to increase intensity.
»Press the DOWN button to decrease intensity.
Step 5: After collecting your "Tremor Task", Cala Trio will
ask if you want to start therapy. Press the MAIN button to
start therapy
Step 6: The 40-minute timer will begin countdown
• Perform "Tremor Task" until all dots are blue (~20 seconds)
UP button
DOWN button
MAIN button