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Welch Allyn PRO ECG Recorder User Manual

Welch Allyn PRO ECG Recorder
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CardioPerfect
PRO ECG Recorder - User Manual
DIR 80012763 Ver. H Revision date: 2017-09
Regulatory Affairs Representative
Welch Allyn Limited
Navan Business Park
Dublin Road
Navan, County Meath,
Republic of Ireland
Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls, NY
13153 USA
www.welchallyn.com
901047 CARDIOPULMONARY ECG SYSTEM
901095 ECG ACQUISITION MODULE
0297
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Welch Allyn PRO ECG Recorder Specifications

General IconGeneral
Device TypeECG Recorder
BrandWelch Allyn
DisplayLCD screen
Lead Configuration12-lead
ConnectivityUSB
Data TransmissionUSB

Summary

Safety and Precautions

RF Interference and Electrostatic Discharge

Discusses RF interference and electrostatic discharge (ESD) risks and precautions for the cardiograph.

Patient and Operational Safety

System Integration and Power Safety

Covers safety when integrating with non-medical equipment and proper power connection practices.

Accessory Usage

Emphasizes using only Welch Allyn approved accessories for warranty and performance.

Warranty, Service, and Spare Parts

Technical Support and Parts Ordering

Information on contacting Welch Allyn for support, troubleshooting, and ordering spare parts.

Product Repair Process

Details the process for obtaining product repairs, including return authorization.

Return Packing Guidelines

Recommended instructions for packing returned goods for service.

Limited Warranty Statement

Warranty Terms and Exclusions

Outlines the product warranty period, what it covers, and common exclusions like misuse or unauthorized repair.

Conventions

Symbol and Term Definitions

Explains various symbols and terms used in the manual, such as Warning, Caution, Note, IPXO, CE Mark.

Electromagnetic Compatibility

EMC Compliance Information

States that the CardioPerfect PRO cardiograph complies with IEC 60601-1-2 limits for EMC.

1. About the CardioPerfect PRO Cardiograph

Cardiograph Overview and Intended Use

Introduces the CardioPerfect PRO Cardiograph and its primary function of recording 12-lead ECGs.

Safety Precautions for Use

Highlights safety warnings related to patient cable use, defibrillation, and cable routing.

1.1 Accessories

Software and Cable Accessories

Lists software upgrades, PC interface cables, and patient cables with their descriptions.

Other System Accessories

Details accessories like utility carts, ECG simulators, electrodes, printers, and flex arm options.

2. Installation

System Installation Requirements

Outlines the necessary steps for installing the software and hardware for the CardioPerfect system.

Connecting and Disconnecting Cables

Provides instructions and warnings for connecting and disconnecting PC interface and patient cables.

2.1 Connecting the patient cable to the electrode.

Patient Cable to Electrode Connections

Illustrates and explains how to connect patient cables to various types of ECG electrodes.

3. Maintenance

Cleaning the ECG Recorder

Instructions and compatible cleaning agents for the PRO ECG Recorder device.

Cable Cleaning and Disinfection

Guidelines for cleaning and disinfecting patient and PC interface cables.

Equipment Inspection and Testing

Daily inspection of equipment and annual verification of electrocardiograph operation and safety.

4. Technical Specifications

Safety, EMC, and Regulatory Compliance

Details compliance with safety (IEC 60601) and EMC standards, and medical device directive.

Equipment Disposal Guidelines

Provides instructions for disposing of the product and its accessories according to local regulations.

5. Guidance and Manufacturer's Declarations

Electromagnetic Emissions Information

Explains EMC emissions compliance and guidance for the CardioPerfect PRO Cardiograph.

Electromagnetic Immunity Overview

Discusses electromagnetic immunity requirements and test levels for the cardiograph.

RF Immunity and Separation Distances

Covers conducted and radiated RF immunity and provides guidance on recommended separation distances.

Recommended RF Separation Distances Table

Table detailing recommended separation distances for RF communications equipment based on transmitter power.

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