Introduction, About this document, Intended use – Welch Allyn CP 50 Plus 12-lead resting electrocardiograph - User Manual User Manual

Page 5: Indications for use

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Introduction

About this document

This document is written for clinical professionals with a working knowledge of medical

procedures and terminology required for monitoring cardiac patients.

Before using the electrocardiograph for clinical applications — or before setting up,

configuring, troubleshooting, or servicing the electrocardiograph — you must read and

understand this document and all other information that accompanies the

electrocardiograph and related options or accessories.

Intended use

The Welch Allyn electrocardiography products (subject devices) are intended for use by

trained operators in health facilities. The subject devices provide the following diagnostic

functions:

Acquiring, viewing, storing, and printing ECG waveforms using ECG front-end

modules (patient cables) and associated accessories that provide signal acquisition

for up to twelve (12) leads of patient ECG waveforms through surface electrodes

adhered to the body.

Using optional algorithms to generate measurements, data presentations, graphical

presentations, and interpretative statements on an advisory basis. These are

presented for review and interpretation by the clinician based upon knowledge of the

patient, the result of physical examination, the ECG tracings, and other clinical

findings.

Indications for use

The electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and

monitor patient cardiac function.

The 12-lead ECG interpretive algorithm provides a computer-generated analysis of

potential patient cardiac abnormalities which must be confirmed by a physician with

other relevant clinical information.

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