VivaQuant Rhythm Express RX-1

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DRAFTClinician’sUserManual

RhythmExpress

ModelRX‐1

ForResearchOnly.

ThisdeviceisnotclearedforsalebyFDA.

VivaQuant

4339NancyPlace,Suite100

St.Paul,MN55126

Tel.1‐866‐ECG‐TRUE(1‐866‐324‐8783)

Rx only CAUTION: U.S. FEDERAL LAW RESTRICTS THIS DEVICE TO SALE ON OR BY THE

ORDER OF A PHYSICIAN.

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CAUTION: Carefully read all instructions prior to use. Observe all warnings and

precautions noted in these directions. Failure to do so may result in patient

complications.

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transmitted in any form or by any means manual, electronic, electromagnetic, chemical, or optical without the written

permission of VivaQuant.

One or more of the following patents may be applicable: US 8,632,465, US 8,478,389, US 8,433,395, US 9,050,007, U.S.

8,632,465, U.S. 8,543,195, U.S. 9,294,074, U.S. 9,314,181, and U.S. 9,339,202. Other US and foreign patents are pending.

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Summary

Manual Overview

Explanation of Symbols Used in this Manual

Explains symbols used in the manual for clarity and safety.

Glossary

Defines key terms and acronyms used in the manual for understanding.

Device Overview and Safety

Device Description and Intended Use

Describes the RX-1 device, its purpose, and indications for use.

Safety Information and Warnings

Details critical safety instructions, warnings, and cautions to prevent harm.

RX-1 Operation and Use

Device Components and Operation

Identifies RX-1 parts and explains basic operational procedures.

Recording Symptoms and Battery Management

Guides on recording patient symptoms and managing battery charging and status.

ECG Lead Connection and Recording Initiation

Provides instructions for attaching ECG leads and starting a recording session.

Maintenance, Service, and Troubleshooting

Storing, Cleaning, and Service

Details procedures for storing, cleaning, and obtaining service for the RX-1 device.

Troubleshooting Common Issues

Lists common problems, their causes, and solutions for the RX-1 device.

Features and Specifications

Rhythm Express RX-1 Features

Highlights key features and capabilities of the RX-1 device.

Technical Specifications

Lists detailed technical specifications including physical, electrical, and environmental parameters.

Warranty and Compliance

VivaQuant Limited Warranty

Outlines the warranty terms and conditions for the RX-1 device.

Wireless Compliance and FCC Statements

Covers FCC compliance, radiation exposure statements, and wireless operation.