EDAN iSE-301 User Manual - Chapter 1 Safety Guidance

SE-301 Series Electrocardiograph User Manual                                 Safety Guidance 

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Chapter 1 Safety Guidance 

This chapter provides important safety information related to the use of the 3-Channel 

Electrocardiograph. 

1.1 Indications for Use/Intended Use 

The intended use of the 3-Channel Electrocardiograph is to acquire ECG signals from adult and 

pediatric patients through body surface ECG electrodes. The electrocardiograph is intended to be 

used only in hospitals or healthcare facilities by doctors and trained healthcare professionals. The 

cardiogram recorded by the 3-Channel Electrocardiograph can help users to analyze and diagnose 

heart disease. However the ECG with measurements and interpretive statements is offered to 

clinicians on an advisory basis only. 

WARNING 

1.  This equipment is not designed for intracardiac use or direct cardiac application. 

2.  This equipment is not intended for home use. 

3.  This equipment is not intended for treatment or monitoring. 

4.  This equipment is intended for use on adult and pediatric patients only. 

5.  The results given by the equipment should be examined based on the overall clinical 

condition of the patient, and they can not substitute for regular checking. 

1.2 Warnings and Cautions 

In order to use the electrocardiograph safely and effectively, and avoid possible dangers caused 

by improper operations, please read through the user manual and be sure to be familiar with all 

functions of the equipment and proper operation procedures before use. 

Please pay more attention to the following warning and caution information.