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The MEMO Patch M is intended to record, transfer and store single-channel electrocardiogram via USB transmission to PC. The monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals. The ECG data is intended to supplement other patient data and is not intended for automated analysis. The device has not been tested and it is not intended for pediatric use.

The MEMO Patch M is a continuous electrocardiogram (ECG) recording device to record, store, and transfer single channel ECGs and is designed for a fully retrospective review of data that was recorded over the specified wear period. The MEMO Patch M has Bluetooth module to verify ECG signals with mobile device and to authenticate the activation of MEMO Patch M. The device is in the form of an ECG patch that records ECG signals. As well the patch connects with a cradle and transmits ECG data via USB communication to PC. Healthcare professional actives the ECG patch, connects the patch with the cradle to the PC, and accesses raw ECG data on the ECG dataloader viewer. The MEMO Patch M includes a battery powered electronic unit that is used with off-the-shelf (OTS) disposable medical grade gel electrodes for long term monitoring. The adhesive electrodes should be replaced by the user every 24 hours or when it no longer adheres to skin. The device is only intended for manual interpretation, and does not provide any automated ECG analysis. The intended clinical use of the ECG is to display the waveforms of the P, QRS, and T waves of the measured electrocardiogram. The intended clinical use of the ECG waveform to be limited to the discrimination of normal sinus rhythm from easily identifiable, non-lethal arrhythmias. The device is not intended for additional analysis or the detection of specific cardiac conditions, such as ischemia, myocardial infarction, and ldft ventricular hypertrophy, etc. The Ambulatory ECG Monitor is intended to capture and continuous electrocardiogram information for long-term monitoring. The device records continuously for the entire wear period, up to 8 days. The MEMO Patch M is a prescription use device and the recorded ECG data is intended to be used with patient-triggered events. When a patient presses the event marking button during a symptom, this event is recorded and displayed on the PDF report of raw ECG data. However, there is no ability to detect specific cardiac events on the PDF report.

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