Chapter 1 Safety Guidance; Indications For Use/Intended Use; Warnings And Cautions; General Warnings - EDAN SE-1515 User Manual

SE-1515 PC ECG User Manual

Chapter 1 Safety Guidance

This chapter provides important safety information related to the use of SE-1515.

1.1 Indications for Use/Intended Use

SE-1515 PC ECG is intended to acquire, process and store ECG signals from adult and pediatric
patients undergoing stress exercise test or resting test. The SE-1515 PC ECG is intended to be
used only in hospitals and healthcare facilities by doctors and trained healthcare professionals.
The cardiogram recorded by the SE-1515 PC ECG can help users to analyze and diagnose heart
diseases. However, the ECG with measurements and interpretive statements is offered to
clinicians on an advisory basis only.
1. This system is not designed for intracardiac use or direct cardiac application.
2. This system is not intended for home use.
3. This system is not intended for treatment or monitoring.
4. This system is intended for use on adult and pediatric patients only.
5. The results given by the system should be examined based on the overall clinical
condition of the patient, and they cannot substitute for regular checking.

1.2 Warnings and Cautions

To use the system safely and effectively, firstly be familiar with the operation method of
Windows and read the user manual in detail to be familiar with the proper operation method for
the purpose of avoiding the possibility of system failure. The following warnings and cautions
must be paid more attention to during the operation of the system.

1.2.1 General Warnings

1. The system 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.
WARNING
WARNING
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Safety Guidance