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General| Brand | Cala Health |
|---|---|
| Model | Cala Trio CT1-STR |
| Category | Medical Equipment |
| Language | English |
Symbols for caution, instructions, disposal, and prescription status.
Symbols indicating ETL certification, MEE, and Class II Equipment.
Symbols for serial number, catalogue number, batch code, and use-by date.
Symbols indicating IP rating, temperature, humidity, and pressure limits.
Specifies the intended use of Cala Trio for treating hand tremors.
Details the components of the Cala Trio therapy system.
Lists conditions or situations where the device should not be used.
Important safety notices and precautions to prevent harm or device damage.
Advisories regarding specific uses or conditions to avoid potential issues.
Describes potential minor/moderate risks or adverse reactions from device use.
Provides instructions for maintaining skin health to prevent irritation.
Guidance on selecting the correct hand for device application.
Instructions for measuring and selecting the appropriate band size.
Explains how to identify the specific postural hold for tremor assessment.
Step-by-step guide on how to correctly wear the device on the wrist.
Process for personalizing therapy by learning about the patient's tremor.
Guidance on adjusting and setting the appropriate stimulation level.
Instructions on how to terminate a therapy session early.
Method for subjects to report changes in tremor severity after therapy.
Steps for safely removing the device from the wrist between sessions.
Instructions on how to charge the Cala Trio device using the base station.
Guide on replacing the worn-out Cala Trio band.
Steps to adjust or change the pre-set stimulation intensity level.
Procedure to recalibrate the device for optimal therapy based on tremor.
Instructions for resetting the device if it becomes frozen or unresponsive.
Guidance on cleaning and proper storage of the device components.
Troubleshooting steps for issues related to charging the device.
Steps to address warnings related to the band's fit on the wrist.
Resolution steps for when therapy stops due to band disconnection.
Information on replacing the band, including time limits for continued therapy.
Steps to resolve internal device errors or malfunctions.
Explanation of the 'powering down' message indicating a device reset.
Guidance for when the device stops working due to high temperatures.
General description of the clinical study design and methodology.
Criteria defining the characteristics of eligible study participants.
Factors that disqualify individuals from participating in the study.
Measures used to evaluate the safety and effectiveness of the device.
Detailed description of the spiral drawing task used for tremor assessment.
Explanation of the Clinical Global Impression-Improvement scale for self-assessment.
Overview of supplementary analyses conducted for the study.
Detailed description of the study protocol and subject visit procedures.
Outline of the statistical methods used to analyze study data.
Summary of the findings from the clinical study.
Overview of the baseline demographic characteristics of the enrolled subjects.
Results and analysis of the main effectiveness measure of the study.
Results and analysis of the secondary effectiveness measures of the study.
Further details on the CGI-I scale results for self-assessed improvement.
Analysis of how the device affected performance in daily living activities.
Responder rates for the TETRAS spiral task during and after stimulation.
Responder rates for the TETRAS Upper Limb Tremor tasks.
Evaluation of how well subjects were blinded to their treatment group.
Limitation that the device was only evaluated for Essential Tremor.
Limitation due to participants taking tremor medication concurrently.
Limitation of assessing effectiveness only at one clinic visit post-stimulation.
Possibility of subjects identifying their group based on stimulation sensation.
Summary of the positive outcomes observed from device use.
Other considerations impacting the risk-benefit assessment of the device.
Specifications related to the duration and control of therapy sessions.
Details about the device's battery and power source.
Information about the type and number of electrodes used.
Conditions under which the device output will cease.
Technical specifications of the electrical output parameters.
Accuracy specifications for device measurements.
Operating and storage conditions for the device.
Environmental parameters for transporting and storing the device.
Environmental parameters for storing the electrodes.
Compliance information for radio frequency emissions.
Guidance on safe separation distances for mobile use.
Declaration regarding electromagnetic emissions of the device.
Declaration regarding the device's immunity to electromagnetic fields.
Immunity levels and conditions related to RF wireless communication equipment.
Information regarding the warranty provided for the purchased product.
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