Search Results

The PhysioGlove ET is intended for self-testing by patients and by health care professionals at home and at medical settings. This 12-lead electrocardiogram (ECG), allows remote patients to display and transmit their ECG data to medical professionals via a mobile platform (communication device) to a remote server. Specifically, the PhysioGlove ET is intended for patients who are concerned about their heart health and have the following problems that are suggestive of abnormal heart function: - · Skipped beats - · Pounding heart (palpitations) - · Heart racing or irregular pulse - · Lightheadedness or faintness - · Chest discomfort - Shortness of breath - · High risk for heart problems - · History of heart problems - · Recipient of heart medications The system only provides waveform parameters for healthcare provider interpretation and does not provide suggested interpretations.

The PhysioGlove ET system is a 12-lead electrocardiograph capable of recording and transmitting standard ECGs for the purpose of cardiac monitoring and diagnosis in a remote location. The PhysioGlove ET system consists of the following 3 primary components: The PhysioGlove - a glove that incorporates a system of Ag/AgCl electrodes for use in recording 12-lead ECGs. The PhysioGlove of the ET system is a modification of the cleared PhysioGlove ES-1 system (originally cleared under K083677 and later incorporated under K103791). In the ET system, however, the PhysioGlove encompasses also electronic elements (mainly a data acquisition circuitry and software packed into the glove, based on the cleared PhysioGlove ES-1) and a recording and transmitting circuitry to permit the transfer of the ECG data to a mobile platform. The Mobile Platform Software - designed to be downloaded to a compatible mobile platform such as a smart cell-phone, a tablet computer, or another communication device. The proprietary Mobile Platform Software is responsible to provide the user with the PhysioGlove ET system operational instructions, as well as to receive the ECG data from the PhysioGlove and to transfer them to the receiving center. No graphical presentation of the acquired ECG is enabled on the mobile platform. The Mercury Telemedicine System (MTS) - proprietary software designed to be installed on a computer in the PhysioGlove ET receiving center (e.g., Nurse Station). The MTS is responsible to receive the recorded ECG data, save it in a database and present it to a medical professional who is capable of interpreting the results. The MTS is based on the PhysioGlove ES-1 software (originally cleared under K050674 and later incorporated under K103791). The PhysioGlove ET system operates as follows: The PhysioGlove records the patient's ECG and sends the data via Bluetooth to a mobile platform. Then, the recorded data is automatically transferred via the Internet using Wi-Fi to connect to a modem or via GPRS cellular communication. The data is sent to a receiving center (e.g., Nurse Station) to be reviewed by a medical professional who is capable of interpreting the ECG data.