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CardioSmart is intended to be used for resting ECG and for recording ECG in realtime with and without arrhythmia detection. CardioSmart is intended to be used by trained operators when ECG records are required in the judgement of a physician. The arrhythmia detection portion of CardioSmart is provided to the user for the convenience of automatic documentation. CardioSmart does not provide alarms for arrhythmia detection. CardioSmart is not intended for use as a vital signs physiological monitor. CardioSmart offers no diagnostic opinion to the user. Instead, it provides interpretive statements for which the physician renders his/her own medical opinion. CardioSmart is not designed for intracardial use. CardioSmart is not intended for home use. The intended use of CardioSmart is a subset of the intended use of the predicate device. CardioSmart is a low cost alternative for all users who are not required to perform stress test ECGs.

CardioSmart is a portable ECG data acquisition and recording system designed and manufactured by HELLIGE GmbH. CardioSmart allows to: - record resting ECGs, - measure and interprete the ECGs.