SE-2003&SE-2012 Series Holter System Recorder User Manual
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Chapter 1 Safety Guidance
This chapter provides important safety information related to the use of SE-2003/SE-2012 series
Holter System Recorder.
1.1 Indications for Use/Intended Use
The SE-2003&SE-2012 Series Holter System (including recorder and analysis software) is
intended to record, analyze, display, edit and generate report of ambulatory ECG. The Holter
System is intended to be used 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,
pediatric patients including infants weighing less than 10 kg.
It can be used for 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.
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.
The Holter recorder belongs to type CF equipment
, and defibrillation shouldn't be
performed on a patient wearing the recorder.
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