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The Nuubo Smart is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, fatigue, or anxiety. The Nuubo Smart continuously records and stores ECG and activity data for up to 30 days at a time. The Nuubo Smart detects arrhythmias at the end of each monitoring day upon download of the ECG data. The Nuubo Smart is Rx use device.

Nuubo Smart is composed of the following main components: Nuubo30 (wearable) - The Nuubo30 is the wearable box that contains one Nuubo30 textile unit, ECG conductive cream, patient instructions and washing bag. Each textile can be used for 30 days. NuuboREC (recorder). The Nuubo recorder is a small, lightweight device that records ECG continuously. The device records 2 Leads of ECG data up to 30 days. The device also records data from a 3-axis accelerometer located inside the device. The patient can activate the button while wearing the product to mark a symptom. To start and stop the recording the user will press the on/off button. The data is stored into a micro SD memory card. Nuubo Dock - The Nuubo Dock is the element for downloading the data from the NuuboREC and uploads that data to the Nuubo Cloud. It consists of a plastic stand with a smartphone attached to it and a microUSB port where the NuuboREC is connected for recharge and data download. The smartphone is a single-purpose device that is intended to be always connected to the dock. The dock is intended to be connected to an outlet in the patient's home with the charger provided. The dock allows to charge the NuuboREC device, and during this charging, it downloads the data from the NuuboREC device into the smartphone. The smartphone is software restricted and can only run the Nuubo Dock App that transmits and receives data from the Nuubo Cloud. Leonardo Smart - Is used for downloading, analysis, visualization and report of the ECG-data stored by the recorder device and for managing the recorder device. The new version Leonardo Smart allows a clinical professional previously authenticated in the platform, to download and review signals recorded by the NuuboREC device which have been uploaded using Nuubo Dock.