One device, two operating modes

TeleHolter Mode

The examination in TeleHolter mode allows the cyclic transmission of several-minute packages with ECG signals and the recording of the entire signal on the device's memory card. ECG signal packages are sent to the Comarch e-Care 2.0 platform and then to the CMAP platform, where artificial intelligence algorithms analyze the transmitted fragment. The use of TeleHolter mode allows medical personnel to verify the results of algorithmic analysis on the telemedical platform. The ability to analyze the full ECG signal and generate a report for the patient is provided through the Comarch Holter software.

Holter Mode

Examinations in Holter mode are conducted offline, allowing the recording of measurement data on the device's memory card. The recorded ECG signal, after the examination is completed, undergoes automatic analysis conducted by the Comarch Holter software. During the examination, the patient has the option to use a functional button in situations previously agreed upon with the doctor, such as moments of discomfort. This designation will be visible to medical personnel during the ECG signal analysis.

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Certification

Comarch S.A. has implemented and certified a quality management system for medical devices ISO 13485. Comarch CardioNow Lite is a medical device certified in accordance with EU Regulation 2017/745 (MDR).

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