Product Manual

SE-601 Series Electrocardiograph User Manual Safety Guidance
- 1 -
Chapter 1 Safety Guidance
This chapter provides important safety information related to the use of SE-601 series
electrocardiograph (hereinafter called SE-601).
1.1 Intended Use
The intended use of SE-601 is to acquire ECG signals from adult and pediatric patients through
body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or
healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by
the 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 internal 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 operation, 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.
1.2.1 Safety Warnings
WARNING
1. The electrocardiograph is intended to be used by qualified physicians or personnel
professionally trained. They should be familiar with the contents of this user manual
before operation.
2. Only qualified service engineers can install this equipment, and only service engineers
authorized by the manufacturer can open the shell.