Product Manual

SE-2003&SE-2012 Holter System Recorder User Manual
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1 Safety Guidance
This chapter provides important safety information related to the use of SE-2003/SE-2012 Holter
System Recorder.
1.1 Intended Use
The SE-2003/SE-2012 Holter System (including analysis software and recorder) is intended to
record, analyze, display, edit and generate report of ambulatory ECG. It is mainly used for (but
not limited to) the following indications:
1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
2. Evaluation of patients for ST segment changes.
3. Evaluation of drug response in patients taking anti-arrhythmic medications.
4. Evaluation of patients with pacemakers.
The Holter system is intended to be used in hospitals and clinics by trained personnel
under the direction of doctors. The analysis results are offered to doctors on an advisory
basis only. The Holter system is intended for adult, paediatric patients and infants weighing
less than 10 kg.
WARNING
1. This recorder is not designed for internal use or direct cardiac application.
2. This recorder is not intended for treatment.
3. The results given by the recorder 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
Consideration of Safety and Efficiency
♦ The dependability of the recorder depends on the proper operation in accordance with
operation and maintenance guidance given in the manual.
♦ The lifetime of the recorder mainly depends on the components validity, which is 5 years
under normal conditions. If components validity exceeds the time limit, the possibility of
aging failure will increase and it may lead to operational failure.
♦ The measure result provided by the recorder is just a reference for physician. The final
diagnosis is made by physician.