2
Questions about Cala Trio? Visit CalaTrio.com/HCPFAQs
LBL-5122 Rev C NOV 2019
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
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3
2.0
Introducing Cala Trio
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4
2.1
Indications for Use
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4
2.2
Cala Trio Therapy Components
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4
3.0
Safety Information
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5
3.1
Contraindications
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5
3.2
Warnings
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5
3.3
Cautions
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5
3.4
Adverse Reactions
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6
3.5
Skin Care Guidelines
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6
4.0
Prescribing Cala Trio
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7
4.1
Choosing the Hand to Treat
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7
4.2
Determining Band Size
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7
4.3
Determining “Tremor Task”
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7
5.0
Setting Up Cala Trio
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8
5.1
Positioning and Fastening Cala Trio
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8
5.2
Calibrating Cala Trio
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9
5.3
Setting Therapy Intensity
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10
6.0
A Therapy Session with Cala Trio
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11
6.1
How to Stop Cala Trio Therapy
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12
6.2
How to Rate your Tremor with Cala Trio
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12
6.3
How to Remove Cala Trio
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12
7.0
Caring for Cala Trio
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13
7.1
How to Charge Cala Trio
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13
7.2
How to Replace Cala Trio Band
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13
7.3
How to Change Stimulation Intensity Preset
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13
7.4
How to Recalibrate Cala Trio
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14
7.5
How to Reset Cala Trio
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14
7.6
How to Clean and Store Cala Trio
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14
8.0
Troubleshooting
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15
9.0
Clinical Study Summary
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16
9.1
Study Overview
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16
9.2
Key Inclusion Criteria
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16
9.3
Exclusion Criteria
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16
9.4
Study Endpoints
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16
9.5
Protocol
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18
9.6
Statistical Analysis Plan
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18
9.7
Study Results
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18
9.8
Adverse Events
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23
9.9
Study Limitations
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23
9.10
Benefit/Risk Discussion
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24
10.0
Technical Specifications
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25
11.0
Electromagnetic Compatibility Declaration
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26
12.0
Warranty Information
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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 affiliates 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 affiliates 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.
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