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The CloudEKG device is a 12 standard leads battery operated unit intended for recording and transmitting standard electrocardiogram signals for cardiac monitoring and diagnosis by healthcare professionals. Recorded signals are processed by the device and transmitted to a PC or hand-held monitoring device wirelessly using Bluetooth technology. The transmitted signals are displayed on the monitoring device to allow for their review, analysis, saving. and printing by healthcare professionals. CloudEKG can be used in adults and infants weighing less than 22 lbs (10 Kg) but is not appropriate for use to monitor critical patients or perform intracardiac recordings. All measurements obtained with the CloudEKG device should take into account the patient's clinical symptoms and findings to be considered valid and no treatment by drugs or other therapies should be initiated based solely on the measurements obtained with the device.

CloudEKG is a compact and mobile digital electrocardiograph system. When in connection wirelessly with a receiving unit, the device can be worn on a patient's body and serves as a stand alone EKG system for the following purposes: - . Acquiring EKG signals - Displaying, processing and storing EKG signals on the receiving unit with the . included POLY-SPECTRUM.NET software - . Cardiac monitoring and medical diagnosis support for qualified health care providers The CloudEKG device is not intended for monitoring critical patients or for intra-cardiac use but can be used in outpatient clinical or doctor practice areas. The device can also be operated by a properly trained patient for home monitoring purposes. The acquired EKG signals are transferred to an external receiving unit via a Bluetooth interface. The signals can be displayed, saved, read, printed and processed by a trained health care provider and transmitted remotely for further use. The delivery set includes an electronic unit, a patient cable, 2 AA batteries, a Bluetooth adapter, software, and a user manual. Depending on the chosen number of leads/standards for recording electrocardiographic signals, recordings can be made from: - 1. Four (4) standard leads (Einthoven and Goldberger) - 2. Six (6) standard leads (Wilson setup) Sensors, button and tab electrodes can be connected to ColudEKG via electrode clips on the ECG cables. With the integrated data transmission technology, EKG data can be transmitted online to a nearby PC or handheld device unit for evaluation. The device's principle of operation is based on the recording and transmission of electrocardiogram (EKG) signals to a PC or handheld device for the purpose of cardiac monitoring and diagnosis. The functional scheme of the device is represented in figure 5-1. The ECG signals collected from the patient are transferred to 8 amplifier channels via the electrodes and cables. The amplified signals are then delivered to multi-channel analog-todigital converter (ADC). The ADC processes the received information and transfers it to PC or handheld device via Bluetooth radio interface. The signals are processed with the POLY-SECTRUM.NET software, displayed and presented in different modes. The data can be stored, or processed to generate exam reports, or printed for qualified health care providers to interpret the result. The required power supply for all electronic components of recording is provided by 2 AA alkaline batteries or rechargeable batteries.