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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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 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.