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General| Brand | BioTel Heart |
|---|---|
| Model | MCOT OS |
| Category | Medical Equipment |
| Language | English |
Explains the purpose and goal of the MCOTos service and provides contact details.
Details the features and operation of the MCOTos monitor device.
Explains the MCOTos sensor, its components, and how it works.
Instructions on how to record symptoms and activity levels using the monitor.
Information on charging and checking the monitor's battery status.
Details on the sensor battery life and replacement procedure.
Step-by-step guide on how to change the electrodes.
Guidance on water activities while using the MCOT system.
Addresses common skin irritation and electrode adhesion problems.
Explains the deactivation message and steps to return the kit.
Explains what patients can expect during their monitoring service period.
Answers whether showering is permitted during the monitoring period.
Discusses the requirement to wear the monitor continuously and exceptions.
Explains the causes of monitor beeping and troubleshooting steps.
Offers solutions for a non-responsive monitor screen.
Explains when physicians receive monitoring reports.
Lists the intended patient populations and conditions for the MCOT system.
Specifies conditions or situations where the MCOT system should not be used.
Outlines essential precautions for using the MCOT system safely.
Lists important cautionary advice for operating the MCOT system.
Provides instructions on how to clean the MCOT system equipment.
Details factors that may limit the MCOT system's coverage and data transmission.
Highlights critical warnings regarding the use and operation of the MCOT system.
Details the physical, functional, and technical attributes of the MCOT system.
Lists the standards and directives the MCOT system adheres to.
Information regarding the device's compliance with FCC regulations.
Specific details on Part 15 of the FCC rules applicable to the device.
Covers privacy practices, HIPAA, and health information management.
Details how health information is used and disclosed.
Outlines patient rights for information access, amendments, and disclosures.
Covers service terms, termination, warranties, and liability.
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