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EDAN SE-601 Series - Chapter 1 Safety Guidance; 1.1 Intended Use; 1.2 Warnings and Cautions

EDAN SE-601 Series
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SE-601 Series Electrocardiograph User Manual
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Chapter 1 Safety Guidance
This chapter provides important safety information related to the use of 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 interpreted ECG with measurements and interpretive statements is only intended
to be used on adult patients and is offered to clinicians on an advisory basis only.
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.
NOTE: This device is not intended for home use.
NOTE: The pictures and interfaces in this manual are for reference only.
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.
3. 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.
4. This device is not intended for treatment.
5. EXPLOSION HAZARD - Do not use the electrocardiograph in the presence of
flammable anesthetic mixtures with oxygen or other flammable agents.
6. SHOCK HAZARD - The power receptacle must be a hospital grade grounded
outlet. Never try to adapt the three-prong plug to fit a two-slot outlet.
7. If the integrity of the external protective conductor is in doubt, the equipment
should be powered by a built-in rechargeable battery.
8. Do not use this equipment in the presence of high static electricity or high

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