Introduction; Intended Use; Indications For Use - Welch Allyn Connex ECG Module Directions For Use Manual

Introduction

This manual describes the capabilities and operation of the Welch Allyn ECG/Impedance
Respiration module. This module is designed as an option for the Welch Allyn Connex®
Vital Signs Monitor (VSM) and the Connex® Integrated Wall System (IWS). This module
might not be available in your region.
When connected to the Connex VSM or the Connex IWS, the module supports the
measurement and continuous display of 3- or 5-lead ECG waveforms, ECG heart rate
readings, and ECG impedance respiration readings. The module also provides optional
pacemaker and arrhythmia detection (ventricular tachycardia, ventricular fibrillation, and
asystole), as well as associated technical and physiological alarms.
Before using the ECG module, read this manual as well as the sections of the Welch
Allyn Connex® Devices directions for use that pertain to your use of the module.

Intended use

The ECG/Impedance Respiration module is intended for continuous measurement of
respiration rate, heart rate, and detection of cardiac standstill (asystole), ventricular
tachycardia, and ventricular fibrillation in general medical and surgical floors, general
hospital and alternate professional healthcare environments. The system is indicated for
use in pediatric and adult patients.

Indications for use

The Welch Allyn ECG/Impedance Respiration module and associated software acquires
and analyzes ECG signals from patients. Patients are people with coronary problems,
suspected coronary problems, or recent medical procedures that require cardiac
monitoring.
This ECG module can be used on adult and pediatric patients.
The ECG module is indicated for use by healthcare professionals whenever there is a
need to monitor a patient's physiological parameters for the following:
• ECG
• ECG with alarms for ventricular tachycardia, ventricular fibrillation, and asystole
• Impedance respiration
CAUTION
United States Federal law restricts this device to sale, distribution, or use
by or on the order of a physician or licensed healthcare professional.
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