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The Holter ECG and ABP system is intended to acquire, analyze, display, edit and generate report of ambulatory ECG, ambulatory blood pressure and combined Holter ECG and ABP data. The analysis results are offered to doctors on an advisory basis only.

Data acquired may be used for the following indications:

• Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
• Evaluation of patients for ST segment changes.
• Evaluation of drug response in patients taking anti-arrhythmic medications.
• Evaluation of patients with pacemakers.

The ambulatory blood pressure function is intended for use in patients over 12 years of age from data collected from an FDA cleared ambulatory blood pressure cuff.

The ECG Analysis function is intended for use in adults and pediatric, but arrhythmia detection is intended for use in patients over 12 years of age.

The Holter ECG and ABP system is intended to be used only in hospital and healthcare facilities by physicians or trained healthcare professionals.

The Holter ECG and ABP system (Model: HolterABP) is a Windows-based application software. It is intended to acquire, analyze, display, edit and generate report of ambulatory ECG data, ambulatory blood pressure data and combined Holter ECG and ABP data that has been stored by the compatible recorders.

The Holter ECG and ABP system provides automatic QRS detection and classification, automatic arrhythmia detection, ST segment measurement and creates summary tables, trends.

The Holter ECG and ABP system display the ABP data, then form the summary table, and statistics information.

The final report can be previewed, printed and saved after the data analysis is completed.

All results obtained from automatic analysis and the resulting unconfirmed reports must be considered as suggestions only.

The subject device is intended only for retrospective analysis, and not for use in real-time monitoring or alarming.

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