Cala Health Cala Trio CT1-STR User manual

HEALTH CARE
PROFESSIONAL GUIDE
Caution: Federal law restricts this device to sale by or on the order of a physician LBL-5122 Rev C NOV 2019

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Manufactured by Cala Health, Inc.
875 Mahler Road, Suite 168
Burlingame, CA 94010
888-699-1009
www.CalaHealth.com
Copyright (c) 2019, 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
1.0 List of Symbols ................................................... 3
2.0 Introducing Cala Trio ........................................... 4
2.1 Indications for Use.................................................4
2.2 Cala Trio Therapy Components ..............................4
3.0 Safety Information ............................................. 5
3.1 Contraindications..................................................5
3.2 Warnings ..............................................................5
3.3 Cautions ...............................................................5
3.4 Adverse Reactions .................................................6
3.5 Skin Care Guidelines .............................................6
4.0 Prescribing Cala Trio............................................ 7
4.1 Choosing the Hand to Treat ...................................7
4.2 Determining Band Size...........................................7
4.3 Determining “Tremor Task” ....................................7
5.0 Setting Up Cala Trio ............................................ 8
5.1 Positioning and Fastening Cala Trio ........................8
5.2 Calibrating Cala Trio..............................................9
5.3 Setting Therapy Intensity..................................... 10
6.0 A Therapy Session with Cala Trio ......................... 11
6.1 How to Stop Cala Trio Therapy ............................. 12
6.2 How to Rate your Tremor with Cala Trio ................ 12
6.3 How to Remove Cala Trio ..................................... 12
7.0 Caring for Cala Trio.............................................. 13
7.1 How to Charge Cala Trio ...................................... 13
7.2 How to Replace Cala Trio Band............................. 13
7.3 How to Change Stimulation Intensity Preset ......... 13
7.4 How to Recalibrate Cala Trio ................................ 14
7.5 How to Reset Cala Trio......................................... 14
7.6 How to Clean and Store Cala Trio ......................... 14
8.0 Troubleshooting................................................. 15
9.0 Clinical Study Summary...................................... 16
9.1 Study Overview ................................................... 16
9.2 Key Inclusion Criteria ........................................... 16
9.3 Exclusion Criteria................................................. 16
9.4 Study Endpoints .................................................. 16
9.5 Protocol .............................................................. 18
9.6 Statistical Analysis Plan....................................... 18
9.7 Study Results ...................................................... 18
9.8 Adverse Events.................................................... 23
9.9 Study Limitations ................................................ 23
9.10 Beneit/Risk Discussion........................................ 24
10.0 Technical Speciications..................................... 25
11.0 Electromagnetic Compatibility Declaration ........... 26
12.0 Warranty Information ........................................ 29
Model: CT1-STR, CT1-STL, CT1-BSR, CT1-BMR, CT1-BLR,
CT1-BSL, CT1-BML, CT1-BLL, CT1-STB, CT1-RSR, CT1-RSL,
CT1-RBS
Disclaimer: Cala Health, Inc. and its afiliates shall not be liable
for any injury or damage suffered by any person, either directly
or indirectly, as a result of the unauthorized use or repair of Cala
Health, Inc. products. Cala Health, Inc. and its afiliates do not
accept any responsibility for any damage caused to its products,
either directly or indirectly, as a result of use and/or repair by
unauthorized personnel.
TABLE OF CONTENTS

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Caution
Refer to instructions for use.
Contains electronic equipment
Properly dispose in accordance
with local regulations.
Conforms to AAMI STD ES60601-1,
IEC 60601-2-10, IEC 60601-1-11
Certiied to CSA STD C22.2#60601-1
Medical Electrical Equipment
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
LIST OF SYMBOLS
1.0 Use by date
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.
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
IP22
40°C
104°F
5°C
41°F
70kPa
101kPa
90%
0%
MEE

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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.
Base
Station
Band
Cala Trio
Stimulator
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
INTRODUCING Cala Trio™
View instructional videos at my.CalaTrio.com
2.0

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This section lists Contraindications and general Warnings,
and Cautions related to the use of Cala Trio therapy. Those
Warnings and Cautions pertaining to speciic 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, deibrillator, or deep
brain stimulator.
»by patients that have suspected or diagnosed epilepsy
or other seizure disorder.
»by patients who are pregnant.
»on swollen, infected, inlamed 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 deibrillator, 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, dificulty 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 inlamed 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 lammable 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

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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 trnsport the device or its ccessories
in tempertures tht exceed the recommended
storge temperture rnge: -20°C to 45°C (-4°F to
113°F). Do not operte the device in tempertures
tht exceed the recommended opertion temperture
rnge of 5°C to 40°C (41°F to 104°F). Temperture
extremes cn dmge the device nd ccessories.
»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
[e-mail].
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
signiicant issues occur, advise the patient to stop using
the device immediately and to consult a 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 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.

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The initial prescription for Cala Trio therapy includes a
stimulator, a three-month band supply, and a base station
for charging. A reill prescription for Cala Trio therapy
includes a three-month band supply every three months
for one year.
There are three steps in writing a prescription:
1. Select hand to treat
2. Determine band size
3. Select “Tremor Task”
4.1 Choosing the Hand to Treat
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 designed to stimulate nerves in the left OR
right wrist. The device is not interchangeable between
the left and right hand.
4.2 Determining Band Size
Cala Trio Band comes in three sizes: Small, Medium,
and Large. To determine the appropriate band size,
measure the subject’s wrist circumference of the
hand chosen for treatment.
To select the correct band size:
1. Measure the subject’s wrist circumference with
a wrist measurement device/measuring tape.
Measure over the wrist bone.
2. Wrap the measuring tape around the wrist. There
should be no visible gaps between the measuring
tape and the skin.
3. Select the appropriate band size according
to the following:
Small: 13.6 – 16.4 cm
Medium: 16.5 – 18.4 cm
Large: 18.5 – 20.4 cm
OR
Outstretched
postural hold
Wing-beating
postural hold
Before using the device, assess both postural holds with
your patient and determine their tremor task. Choose the
more severe postural hold. Advise the patient that this
speciic “Tremor Task”, either the outstretched OR wing-
beating hold, will be done when the device prompts them
for a tremor task.
PRESCRIBING Cala Trio™
4.0
4.3 Determining “Tremor Task”
The “Tremor Task” is a postural hold that helps
characterize the patient’s tremor. It is integral to the
therapy as the patient will perform the hold:
• during setup to deine the patient’s baseline
tremor before starting therapy and to calibrate the
individualized therapy.
• before and after therapy to characterize its impact.
You shall determine the tremor task to be the more
severe of the following two postural holds:
outstretched OR wing-beating.

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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
5.1 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 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
Note: Correct placement of the Cala Trio Band electrodes
is essential to therapy success.
Step 1: Dampen entire wrist circumference with ample
amounts of water before positioning Cala Trio
• 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.
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
SETTING UP Cala Trio™
View instructional videos at my.CalaTrio.com
5.0
Step 5: Pull the end of the Cala Trio Band to tighten—
fasten the Velcro securely and tightly

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• Should be snug enough so it does not slide along or
around the wrist.
• The electrodes should be lush to the skin.
ElectrodeElectrode
Right Handed
Device
Left Handed
Device
5.2 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.
Before calibrating, determine your "Tremor Task" by
checking your prescription information
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
UP button
DOWN button
MAIN button
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"
OR
Outstretched
postural hold
Wing-beating
postural hold
Step 3: Get in position to do your "Tremor Task"
(see above) You can ind your "Tremor Task" in
your prescription information
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
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.
Determine your "Tremor Task" by checking your
prescription information.

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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.
5.3 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.
To set the intensity:
Step 1: Press the MAIN button from "press main to set
intensity". Wait 3 seconds before moving to step 2
Step 2: Press the UP button to slowly increase intensity.
You may not feel the sensation right away
UP button
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
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 5.1, page 8) or
adjust the placement of the band (see section 5.1,
step 3, page 8).
»Repeat steps 1-3 when you are ready to set your
intensity again (see section 5.3, page 10).
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.
Step 5: Press the MAIN button to save the intensity preset
Your Cala Trio therapy is
personalized and ready to use!
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 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
periodically before and after therapy sessions. Cala Trio
will prompt you in a similar way as described in section
5.2, steps 3-5, on page 9.
A therapy session with Cala Trio is easy to start and it
into your day.
UP button
DOWN button MAIN button
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.
• Get in position to do your "Tremor Task".
• Press the MAIN button to start the measurement.
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
A THERAPY SESSION WITH Cala Trio™
View instructional videos at my.CalaTrio.com
6.0

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6.1 How to Stop Cala Trio™Therapy
After 40 minutes, Cala Trio Therapy will automatically
stop when the countdown timer reaches zero minutes and
Cala Trio displays “therapy complete”.
Step 1: To stop therapy early, press and hold the MAIN
button until you see "therapy stopped"
• When therapy stops, Cala Trio vibrates to indicate
therapy has stopped or is complete.
• If you were prompted to do your "Tremor Task" before
therapy, it will prompt you to perform your "Tremor
Task" again after therapy (repeat section 6.0, steps 3
and 4 on page 11).
6.2 How to Rate Your Tremor with Cala Trio™
After collecting your "Tremor Task", Cala Trio will ask you if
your "Tremor Task":
To rate how your tremor level has changed compared to
before therapy:
Step 1: Press the MAIN button to bring up the
rating display
Step 2: Press UP button or DOWN button to highlight
the rating you want
Step 3: Press MAIN button to save your rating
You have successfully completed a
therapy session with Cala Trio!
Step 1: Make sure therapy has stopped. If you are in the
middle of a session, press and hold the MAIN
button until you see "therapy stopped" (see
section 6.1)
Step 2: Unfasten the band to release the Velcro connection
Step 3: Remove Cala Trio from wrist
Note: Leave the stimulator and band attached until you
are prompted to replace the band. Cala Trio will display
"replace band" in order to maintain effective therapy (see
section 7.2 on page 13).
6.3 How to Remove Cala Trio™
AVOID REMOVING Cala Trio DURING THERAPY
Between sessions, you can remove Cala Trio by:

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7.1 How to Charge Cala Trio™
Charge Cala Trio
• Overnight
• With band attached to the stimulator
Note: The band must be attached to the stimulator in
order to charge.
Step 1: Place the stimulator with the band attached into
the base station
»Cala Trio displays that it is charging and then fades to
sleep after a few seconds.
»The base station will also communicate its status via a
light. The table below shows the status light options:
white light device connecting, ready to charge
green light charging
yellow light device updating , do not remove
from base station
red light replace Cala Trio Band
status light
7.2 How to Replace Cala Trio™Band
Cala Trio will display “replace band” in order to maintain
effective therapy.
Step 1: Check that the size and the handedness of the
band matches your prescription information.
Step 2: Remove the used band by unsnapping it
from the stimulator
Step 3: For the new one, align the half circle cut outs on
the back of the band and stimulator as you snap
them together
Step 4: Place the stimulator attached to the new band
in the base station for 15 seconds in order to clear
the "replace band" message
7.3 How to Change Stimulation
Intensity Preset
Change the preset if you would prefer a different
stimulation intensity for therapy.
Step 1: From the time display, press the UP or DOWN
buttons until you see “intensity setting”. Press the
MAIN button
Step 2: Press the DOWN button to highlight 'reset.'
Then press the MAIN button
Step 3: Use the UP button to increase the therapy to an
appropriate level. See steps 2-3 in section 5.3 on
page 10 for more detail
Step 4: Press the MAIN button to stop the therapy. Then
press the MAIN button again to save the intensity.
You will now see the clock
CARING FOR Cala Trio™
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7.0

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7.4 How to Recalibrate Cala Trio™
In order to ensure effective therapy, or if the device
is calibrated incorrectly Cala Trio may need to be
recalibrated after initial setup.
UP button
MAIN button
Step 1: From the time screen, press the UP and DOWN
buttons simultaneously for three seconds to enter
the Calibration Menu
Step 2: Instruct the patient to perform their prescribed
“Tremor Task" and press the MAIN button to start
the calibration. Have the patient continue their
“Tremor Task" until all dots are blue (20 secs).
The device will vibrate to indicate when the
“Tremor Task" is complete
Step 3: After calibration, press MAIN to save. If you do
not want to save the calibration, press DOWN
and then MAIN to exit
Cala Trio therapy is re-calibrated
and ready to use!
Step 2: Release the buttons and Cala Trio will
automatically restart displaying Cala Trio
7.6 How to Clean and Store Cala Trio™
To clean Cala Trio Therapy components, use a disinfecting
wipe as often as once per week.
When not using therapy, charge Cala Trio overnight on the
base station. Alternatively, store Cala Trio in the included
microiber bag at room temperature.
Note: Do not place or store a Cala Trio band on top of the
base station unless it is attached to a Cala Trio stimulator.
7.5 How to Reset Cala Trio™
If Cala Trio is frozen or otherwise performing in a way that
you do not expect, you may perform a reset.
Step 1: Press and hold the MAIN and UP buttons at
the same time for a few seconds until Cala Trio
displays “powering down”
UP button
DOWN button

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If you have any issues using Cala Trio such as
unexpected events or changes in performance, please
irst refer to the content in this section. If issues
continue, please contact Cala Health at 888-699-1009
or [e-mail]
Band Not Connected
Therapy has stopped. To resolve the issue:
Step 1: Press MAIN button to exit the warning
Step 2: If prompted, complete the post therapy
"Tremor Task" and rating
Step 3: Remove Cala Trio from your wrist
Step 4: Ensure the stimulator is securely and correctly
snapped into the band (half circles should be
aligned as shown in section 5.1 on page 8)
Step 5: Dampen your wrist
Step 6: Tightly secure Cala Trio on your wrist
Step 7: Restart therapy. If warning persists, stop using
Cala Trio and contact Cala Health at 888-699-
1009 or [e-mail]
Error
Cala Trio has stopped functioning due to an internal error.
Press and hold the MAIN button for a few seconds to
reset the stimulator. Use stimulator as instructed. If the
error persists, contact Cala Health at 888-699-1009 or
[e-mail].
Charge Device
Cala Trio needs to be charged. Place Cala Trio, with the
band attached, into the base station. Note the band must
be attached in order for the device to charge.
Replace Band
Replace band as soon as possible. Therapy will be available
for ten days after the irst appearance of this message.
See section 7.2 on page 13 for directions on disconnecting
and connecting the stimulator and band.
Adjust Band on Wrist
Follow the same steps listed on above for Band Not
Connected warning.
Replace Band
Replace band as soon as possible. Therapy will not be
available until a new band is attached. See section 7.2 on
page 13 for directions on disconnecting and connecting
the stimulator and band.
Powering Down
Appears when the stimulator resets.
Temperature Exceeded
Cala Trio has stopped working because the temperature is
too high inside the stimulator. Remove it from your wrist
and allow the stimulator to cool down.
TROUBLESHOOTING
View instructional videos at my.CalaTrio.com
8.0

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LBL-5122 Rev C NOV 2019
9.1 Study Overview
The study was multi-center, prospective, randomized,
double-blinded, and sham-stimulation controlled. Each
subject was seen for a single three-hour appointment at
a study site. Subjects were randomized one-to-one to
either the investigational TAPS stimulation (“treatment”
group) or sham stimulation (“sham” group). The TAPS
stimulation amplitude for the treatment group was based
on each subject’s stimulation threshold. The sham group
received 0-amplitude stimulation. The study site personnel
and investigator were not blinded and knew the subject’s
therapy allocation. However, the subject and the raters
assessing the primary effectiveness endpoint were blinded.
The subjects’ tremor severity was assessed before, during,
and immediately after the 40-minute stimulation session
using various metrics. Safety was assessed using adverse
event data collected during the study.
9.2 Key Inclusion Criteria
1. At least 22 years of age
2. A diagnosis of essential tremor as conirmed from
clinical history and examination by a movement
disorder neurologist
3. At least one hand exhibiting kinetic tremor ≥ 2 as
assessed by the Essential Tremor Rating Assessment
Scale (TETRAS) Archimedes spiral task completed
during the baseline evaluation, as assessed by the
Investigator in-person.
4. Score of 3 or above in any one of the items of the
Bain & Findley Activities of Daily Living Scale
9.3 Key Exclusion Criteria
1. Implanted electrical medical device, such as a
pacemaker, deibrillator, or deep brain stimulator
2. Previous thalamotomy procedure, including
Stereotactic Thalamotomy, Gamma Knife
Radiosurgical Thalamotomy, and focused
ultrasound, for the treatment of tremor
3. Suspected or diagnosed epilepsy or other
seizure disorder
4. Pregnant
5. Swollen, infected, inlamed areas, or skin eruptions,
open wounds, or cancerous lesions of skin at
stimulation site
6. Peripheral neuropathy affecting the tested
upper extremity
7. Alcoholism (score of 4 or higher on DSM-5)
8. Other possible causes of tremor, including
Parkinson’s disease, drug-induced, enhanced
physiological tremor, dystonia
9. Other neurodegenerative disease like Parkinson-plus
syndromes suspected on neurological examination.
These include: multisystem atrophy, progressive
supranuclear palsy, dementia with Lewy bodies,
and cortical basal ganglionic degeneration
10. Changes in medication for tremor within 1 month prior
to study enrollment
11. Change in antidepressant medication within 3 months
prior to study enrollment
12. Botulinum Toxin injection for hand tremor within 6
months prior to study enrollment
13. Alcohol or caffeine consumption within 12 hours of
study enrollment
Subjects already taking medications for their essential
tremor remained on their medications during the study.
9.4 Study Endpoints
Safety
The primary safety endpoint was an analysis of adverse
events types and rates for all enrolled subjects.
Effectiveness
• The primary effectiveness endpoint was a signiicantly
greater change in the treatment group compared to
the sham group in the TETRAS Archimedes spiral
rating after stimulation compared to baseline. An
analysis of covariance (ANCOVA) model was used to
assess the statistical signiicance of the difference in
the mean change between the treatment and sham
groups. The model included the baseline score as a
continuous covariate, and randomization assignment
as a classiication variable.
CLINICAL STUDY SUMMARY
9.0

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»TETRAS Archimedes Spiral Task
The TETRAS Archimedes Spiral Task requires
subjects to copy a spiral drawing in a 10-cm sized
square. At baseline, the investigator rated the spiral.
To determine if the subject met the inclusion criteria
of a minimum score of 2, the investigator rated the
spirals on the 5-point (0-4) TETRAS scale with
1-point resolution:
0= normal
1= slight: tremor barely visible.
2= mild: obvious tremor
3 = moderate: portions of igure not recognizable.
4= severe: igure not recognizable
Note: The investigators were required to rate the spirals
using a 1-point resolution to assess inclusion into the
study, whereas the blinded raters could use a 0.5-point
resolution using the same scale for the assessment of
baseline and subsequent measures.
In order to account for multiplicity, the secondary
effectiveness endpoints were to be analyzed using
a stepwise gate-keeping approach, whereby each
subsequent hypothesis would only be tested if the
preceding null hypothesis was rejected and secondary
endpoint hypotheses would only be tested if the
primary endpoint null hypothesis was rejected.
• The secondary effectiveness endpoints were:
- a signiicantly greater change in the treatment
group compared to the sham group in the TETRAS
Archimedes spiral rating during stimulation
compared to baseline
- a signiicantly greater self-reported improvement in
the treatment group (CGI-I scale) compared to the
sham group.
»CGI-I Scale
The Clinical Global Impression-Improvement (CGI-I) scale
is a 7-point self-report scale that required the subject
to assess how much their tremor level has improved or
worsened relative to their baseline ate prior to the
session. The subject reported their improvement on the
7-point CGI-I scale defined as follows:
1= Very much improved
2= Much improved
3= Minimally improved
4= No change
5= Minimally worse
6= Much worse
7= Very much worse
• Additional Exploratory Analyses:
»Bain & Findley ADL Scale
To thoroughly document tremor severity, the
complete 25-item scale was administered at baseline.
A subset of 7 Bain & Findley ADL tasks that can be
performed unilaterally (using one hand) and do not
require the dominant hand were performed by the
subject at baseline and after the session to evaluate
functional improvements in activities of daily living.
These 7 tasks were:
- Use a spoon to drink soup
- Hold a cup of tea
- Pour milk from a bottle or carton
- Dial a telephone
- Pick up your change in a shop
- Insert an electric plug into a socket
- Unlock your front door with a key
The subjects (blinded as to whether they received
stimulation or sham) performed the tasks and rated
themselves from 1-4 on the following Bain & Findley
ADL scale:
1= Able to do the activity without dificulty
2= Able to do the activity with a little effort
3= Able to do the activity with a lot of effort
4= Cannot do the activity by yourself
»TETRAS Upper Limb Tremor (ULT)
The TETRAS Upper Limb Tremor assessment included
three tasks to assess tremor severity: forward
outstretched posture, lateral “wing beating” posture,
and kinetic inger-nose-inger testing. At baseline,
each upper limb was assessed and scored individually
by the investigator using the TETRAS rating scale
(0-4 scale with 8-point resolution) described below.
The TETRAS Upper Limb Tremor tasks were repeated
during and after stimulation, and scored by the
investigator using the same TETRAS rating scale.
0= no tremor
1= tremor is barely visible
1.5 = tremor is visible, but less than 1 cm
2= tremor is 1- < 3 cm amplitude
2.5 = tremor is 3- < 5 cm amplitude
3= tremor is 5- < 10 cm amplitude
3.5 = tremor is 10- < 20 cm amplitude
4= tremor is > 20 cm amplitude

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»Responder Rate
Additionally, the responder rate by therapy
allocation, was calculated for each of the TETRAS
tasks, where the responder rate was deined as the
percentage of subjects with a ≥ 0.5 point improvement
from baseline.
9.5 Protocol
For each subject’s single in-clinic visit, baseline
measurements of the study effectiveness endpoints
were taken prior to stimulation with treatment or sham.
After 20 seconds at a speciic stimulation level, the device
automatically transitioned into a 40-minute stimulation
session of treatment with TAPS (Cala ONE device will
continue stimulating at the same level) or sham (Cala
ONE device will transition to 0 amplitude stimulation).
The device continued operating for 40 minutes. Endpoint
measurements were taken during and after stimulation.
During stimulation the subject repeated the same set of
TETRAS tasks that were performed during baseline, at 30
+/- 5 minutes into the session. A study-trained neurologist
rated all performed TETRAS tasks in-person, except for
the Archimedes spiral task, which was rated later by
blinded raters.
After the 40-minute stimulation session, the Cala ONE
device automatically turned off. With the Cala ONE
device remaining on the subject’s wrist, the neurologist
instructed each subject to repeat the same set of TETRAS
tasks. The neurologist rated all performed TETRAS tasks
in-person, except for the Archimedes spiral task, which
was rated later by blinded raters.
Next the subject repeated the same Bain & Findley ADLs
completed during baseline, and rated themselves on
each task. The subject also assessed any changes in their
tremor level (compared to baseline) using the Clinical
Global Impression– Improvement (CGI-I) scale.
For the effectiveness endpoints and to assess whether the
subject met the criteria to be included in the Effectiveness
Analysis Population (see below), 3 independent blinded
raters evaluated the Archimedes spirals collected at
baseline, during, and after stimulation as described above.
The raters were board certiied neurologists trained in
movement disorders, and were blinded to the therapy
allocation (sham or treatment) and to the spiral order
(e.g., baseline, during, or after stimulation). The
independent blinded raters rated the spirals using the
5-point (0-4) TETRAS scale using a 0.5-point resolution.
The scores from all three raters were averaged to get the
inal rating for each spiral.
9.6 Statistical Analysis Plan (SAP)
• Analysis populations
»The primary and secondary effectiveness endpoints
were assessed on the Effectiveness Analysis
Population (EAP), which was deined as the enrolled
subjects with a baseline TETRAS spiral rating ≥ 2 as
assessed by the average score from 3 independent
blinded raters.
»Per protocol (PP) analysis set included subjects
who had no major protocol deviation and was
done as sensitivity analysis for primary and
effectiveness endpoints.
»Safety analysis included all enrolled subjects.
• Safety Analysis
Adverse event (AE) rates were planned to be presented
on all enrolled subjects, overall as well as by treatment
group. The rates of events and type were presented and
compared between groups using the Fisher’s Exact test.
• Blinding Assessment
The successfulness of the blinding of subjects was
assessed at the end of the study visit using a blinding
assessment questionnaire. Subjects were asked whether
they thought they were in the active or sham group or
if they do not know on a three-point scale. The sponsor
calculated the distribution of the responses to this
assessment.
9.7 Study Results
Subject Disposition
The irst subject was enrolled on 11-Apr-2016 and the
last subject completed on 4-Nov-2016. The subject
disposition is provided in Figure 9. A total of 111 subjects
were screened for the study, and 93 subjects were enrolled
and randomized. 48 subjects were randomized to receive
TAPS stimulation (“treatment” group), and 45 subjects
were randomized to receive 0-amplitude sham stimulation
(“sham” group). 92 of the 93 enrolled subjects completed
the study; one subject discontinued because the subject’s
wrist circumference was outside the range of wrist
circumferences for which the Cala ONE is designed. Of the
92 subjects who completed the study, 77 (37 in the sham
group and 40 in the treatment group) met the pre-speciied
EAP criteria of having a baseline TETRAS Archimedes
spiral rating ≥ 2, as assessed by the three blinded raters.
As prespeciied in the investigational plan, effectiveness
was assessed on the Effectiveness Analysis Population,

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which is deined as the enrolled subjects with a baseline
TETRAS spiral rating ≥ 2, as assessed by the average score
from three independent blinded raters. Due to potential
differences between the in-person spiral rating from
the investigator and the spiral rating averaged across 3
blinded raters, it was possible that a few enrolled subjects
who met the inclusion criteria of a baseline TETRAS spiral
rating ≥ 2 as assessed by the investigator, would not
meet the criteria of a baseline TETRAS spiral rating ≥ 2
as assessed by the average score from the three raters.
In this situation, these subjects were not included in the
Effectiveness Analysis Population (EAP).
Analysis Populations
The numbers of subjects in each of the pre-speciied
analyses populations are summarized in Table 3 and
described in the subsections below.
TABLE 2
Analysis Populations of Subjects
Total Treatment Sham
Enrolled Population 93 48 45
Effectiveness Analysis
Population (EAP) 77 40 37
Per-Protocol (PP)
Analysis Population 630 30
Subject Demographics
Subjects enrolled in the study were on average 70.2 years
old (range: 35 – 89 years) and had been diagnosed with
ET for on average 31.4 years (range: 2 – 77 years). 61% of
subjects were currently taking at least 1 medication for
their tremor, and 59% had received at least one prior
form of treatment for ET. Subjects enrolled in the study
TABLE 3
Baseline characteristics of Effectiveness
Analysis Population (N = 77)
Overall
(N=77)
Treatment
(N=40)
Sham
(N=37)
Age of onset in years
Mean (SD) 38.8 (21.2) 40.2 (21.7) 37.2 (20.7)
Range 5 – 71 5 - 70 5 – 71
Age of diagnosis in years
Mean (SD) 53.4 (14.6) 54.3 (13.9) 52.4 (15.4)
Range 12 – 78 18 - 78 12 – 75
Family history of
ET, yes, n(%) 59 (77%) 32 (80%) 27 (73%)
Current Tremor co-therapy, n(%)
None 28 (36%) 13 (33%) 15 (41%)
1 medication 29 (38%) 15 (38%) 14 (38%)
>1 medication 20 (26%) 12 (30%) 8 (22%)
Prior Treatments of ET, n(%)
Medication 48 (62%) 24 (60%) 24 (65%)
Botox 4 (5.2%) 3 ( 7. 5%) 1 (2.7%)
DBS 0 (0.0%) 0 (0.0%) 0 (0.0%)
Other 3 (3.9%) 2 (5.0%) 1 (2.7%)
Baseline TETRAS Spiral (min score=0, max score=4)
Mean (SD) 2.8 (0.6) 3.0 (0.7) 2.6 (0.5)
Range 2.0 – 4.0 4.0 – 2.0 2.0 – 4.0
Baseline TETRAS Performance Subscale, total score (min
score=0, max score=64)1
Mean (SD) 26.2 (5.9) 26.7 (5.9) 25.7 (5.9)
Range 16 – 42 17 - 39 16 – 42
Baseline Bain & Findley ADL, total score (min score=25, max
score=100)2
Mean (SD) 44.9 (9.4) 45.7 (9.0) 44.0 (9.8)
Range 30 – 69 31 - 67 30 – 69
QUEST summary index (min score=0, max score=1)3
Mean (SD) 0.32 (0.15) 0.30 (0.13) 0.33 (0.17)
Range 0.03 - 0.65 0.11 - 0.63 0.03 - 0.65
1The total score is the sum of the scores from the 16 TETRAS tasks.
2The total score is the sum of the scores from the 25 ADL tasks.
3The summary index is calculated as the average of the
percentage for each of the 5 domains
Screened
(n=111)
Enrolled and Randomized
(n=93)
Screen Failures
(n=18)
Treatment
(n=48; 40 in EAP)
Sham
(n=45; 37 in EAP)
Completed
(n=48; 40 in EAP)
Discontinued
(n=1; 0 in EAP)
Completed
(n=44; 37 in EAP)
Figure 9: Subject Disposition Chart

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on average had moderate tremors, as demonstrated
by an average baseline Bain & Findley ADL total score
of 45.4 (out of 100), an average baseline upper-limb
TETRAS score of 25.3 (out of 64), and an average Quality
of life in Essential Tremor Questionnaire (QUEST) score
of 0.31 (out of 1). There were no statistical differences
between the treatment and sham groups in the enrolled
population related to subject demographics or baseline
characteristics.
In the EAP and PP, there was a statistical difference or
borderline statistical difference between the treatment
and sham groups in their baseline TETRAS Spiral rating
(p = 0.021 and p = 0.065, respectively). Baseline spiral
rating was accounted for in the primary effectiveness
endpoint analysis of covariance model.
Primary Endpoint
After 40 minutes of device use, the treatment group
improved by an estimated 0.56 points, whereas the
sham group improved by an estimated 0.39 points. The
improvement in both groups was highly statistically
signiicant compared to their own baseline (p < 0.0001
and p = 0.0096, respectively), and the baseline score was
not a signiicant covariate. However, the improvement in
the treatment group was not statistically signiicantly
TABLE 4
Descriptive statistics of TETRAS Spiral ratings before
and after stimulation (EAP; N = 77)
Baseline Post
N mean ± SD Range mean ± SD Range
Treatment 40 2.95 ± 0.68 2.00 -
4.00 2.41 ± 1.00 0.50 - 4.00
Sham 37 2.63 ± 0.52 2.00 -
4.00 2.23 ± 0.80 0.50 - 4.00
TABLE 5
Primary Effectiveness Endpoint: Change in TETRAS Spiral
ratings after stimulation - parameter estimates from
ANCOVA (EAP; N=76)1
NMean (95%CI) Std.
Error p-value p-value (Group)
Treatment 40 -0.56
( -0.76 - -0.35) 0.102 <.0001
0.263
Sham 36 -0.39
( -0.60 - -0.17) 0.108 0.0006
1One of the 77 EAP subjects had missing po-imulation TETRAS
Spiral rating data; therefore, the N for this analysis is 76.
TABLE 6
Summary of population-based sensitivity analyses of
primary effectiveness endpoint
Treatment
NMean (95%CI) Std.
Error p-value
All
Enrolled148 -0.47
( -0.65 - -0.30) 0.088 <.0001
Per-
Protocol 30 -0.66
( -0.89 - -0.42) 0.119 <.0001
Sham
NMean (95%CI) Std.
Error p-value p-value (Group)
All
Enrolled143 -0.39
( -0.57 - -0.20) 0.093 <.0001 0.5208
Per-
Protocol 30 -0.37
( -0.61 - -0.13) 0.119 0.0028 0.1034
1Two of the 93 enrolled subjects had missing post-stimulation
TETRAS Spiral rating data; therefore, the N for this analysis is 91.
greater than the improvement in the sham group (p =
0.263). Therefore, the primary effectiveness endpoint was
not met. Further, the observed difference in improvement
between the groups (0.17 points) was not considered to be
clinically meaningful.
Sensitivity analyses on the primary effectiveness endpoint
were performed using the Enrolled Population and the
Per-Protocol Population. For both populations, the
treatment group experienced a greater improvement in
tremor compared to the sham group, and the baseline
score was not signiicant in the model; however, the
difference between the treatment and sham groups was
not found to be statistically signiicant.
Secondary Endpoints
To account for multiplicity, the statistical analysis plan
speciied that secondary endpoints may only be tested if
the primary endpoint was met. Since the primary endpoint
was not met p-values are not provided.
1. Change in spiral ratings during stimulation:
The average, standard deviation, and ranges of
the spiral ratings before (at baseline) and during
stimulation for EAP are provided in Table 7. On
average, subjects in the treatment group had a
baseline spiral rating of 2.95, and subjects in the
sham group had a baseline rating of 2.63; both