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Cala Health Trio User Manual

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

General IconGeneral
CategoryMedical Equipment
IndicationEssential tremor
Power SourceRechargeable battery
ConnectivityBluetooth
Control MethodMobile app
Prescription RequiredYes
FDA ClearedYes
Target AreaPeripheral nerves in the wrist
Therapy Duration40 minutes per session
TreatmentNon-invasive Peripheral Nerve Stimulation
ApplicationWorn on the wrist

Summary

List of Symbols

Introducing Cala Trio

Indications for Use

Cala Trio is indicated to aid in the transient relief of hand tremors in adults with essential tremor.

Cala Trio Therapy Components

Details the components of the Cala Trio Therapy System: Stimulator, Band, and Base Station.

Safety Information

Warnings

Lists critical safety warnings regarding device usage, contraindications, and potential risks.

Cautions

Provides cautions for proper use, storage, and potential side effects like skin irritation.

Adverse Reactions

Describes possible minor/moderate risks and more significant issues to watch for during therapy.

Setting Up Cala Trio

Positioning and Fastening Cala Trio

Instructions on how to correctly position and fasten the Cala Trio device on the wrist for effective therapy.

Calibrating Cala Trio

Explains the calibration process to personalize therapy based on tremor characteristics.

Setting Therapy Intensity

Guidance on setting the stimulation intensity preset for comfortable and effective therapy sessions.

A Therapy Session with Cala Trio

How to Stop Cala Trio Therapy

Instructions on how to stop the Cala Trio therapy session early or when it is complete.

How to Rate Your Tremor with Cala Trio

Procedure for rating tremor level changes after a therapy session.

How to Remove Cala Trio

Steps for safely removing the Cala Trio device from the wrist between therapy sessions.

Caring for Cala Trio

How to Charge Cala Trio

Instructions on charging the Cala Trio device overnight using the base station.

How to Replace Cala Trio Band

Guidance on replacing the Cala Trio band to maintain effective therapy.

How to Change Stimulation Intensity Preset

Steps to change the stimulation intensity preset for therapy.

How to Reset Cala Trio

Procedure for resetting the Cala Trio device if it becomes frozen or performs unexpectedly.

How to Clean and Store Cala Trio

Instructions for cleaning and storing the Cala Trio components properly.

Troubleshooting

Clinical Study Summary

Technical Specifications

Electromagnetic Compatibility Declaration

Warranty Information

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