CE approval YRS100

YourRhythmics B.V. has requested DARE!! Medical Certifications to perform the End Product Verification of the YRS100 ECG cardiac amplifier within the framework of the Medical Devices Directive, based on Annex IV of the Medical Devices Directive 93/42/EEC (MDD). A Product Verification of the final production of the ECG acquisition system has been performed. DARE!! Medical Certifications stated at November 4th 2019 that, based on the verification of the batch supplied by the manufacturer, the assessed batch is considered to be in compliance with the essential requirements of the Medical Devices Directive.

The classification of the YRS100 ECG cardiac amplifier is IIa, according to annex IX of the MDD and the safety class is Class I-CF, which makes this device suitable for clinical research on patients (suspected of) suffering from cardiac arrhythmias.

The YRS100 is a 40-channel cardiac amplifier capable of measuring non-invasive ECG-signals. The device records these signals with a sampling rate of 2 kHz per channel and a 24 bits resolution to provide excellent signal quality. ECG cables are included to connect with 2 x 10 body surface electrodes. The bipolar and unipolar can be used to measure an esophagus or body surface ECG. All patient connections are isolated from the PC- and the mains side and the system is defibrillation proof.

YourRhythmics operates from a basis of decades of research on analysis of atrial fibrillation signals by researchers from the groups of Prof. Dr. U. Schotten and Prof. Dr. H. Crijns from the Maastricht University Medical Center. They performed a lot of research on non-invasive characterisation of atrial fibrillation (AF) substrate complexity based on the electrocardiogram (ECG). Many research papers have been published that demonstrate how AF complexity parameters may improve outcome prediction in patients receiving rhythm control therapies for AF.

This has resulted in the establishment of YourRhythmics B.V. in 2016. The company offers a product portfolio to non-invasively measure the AF complexity of AF patients. YourRhythmics has the ambition to provide a decision-support tool to choose the most effective therapy for the individual AF patient.

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