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The PhysioGlove ES Model I is a reusable 12-lead diagnostic ECG examination system. The system can be used with 12-lead cables or the PhysioGlove device. When used with the PhysioGlove, it is intended to conduct an electrocardiogram. The diagnostic and automatic measurement features are not available. When used with a 12-lead cable, it is intended for use in resting diagnostic electrocardiograph examination of adults. The PhysioGlove ES Model I is intended for use in physician offices, hospitals, outpatient clinics, or similar settings by or on the order of a physician or similarly qualified healthcare professional. The device provides waveform parameters and ECG analysis for healthcare provider interpretation. The PhysioGlove ES Model I ECG Analysis Program assists the physician in measuring and interpreting 12-lead EGGs for rhythm and contour information by providing an initial automated interpretation. Interpretation by the product is then confirmed, edited, or deleted by the physician. The analysis program is intended for use in the general population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities. The analysis program is intended for use in hospitals, outpatient clinics, emergency departments, and out-of hospital sites such as ambulances and patients' homes.

The PhysioGlove ES Model I is a diagnostic electrocardiograph for 12-Lead resting ECGs. The system consists of an electronics data acquisition unit and software that runs on a medical grade PC. The system uses either a standard, FDA-cleared, 10electrode EGG cable, or the PhysioGlove to obtain ECG data from the patient. The electronics performs analog processing and analog to digital conversion of a 12 lead diagnostic ECG. The digital packets from the front-end enter the PC via the USB port. The software for the PC performs a variety of functions, including patient registration, ECG display, and storage. In addition the system provides ECG analysis. The ECG Analysis Program is a software algorithm only. When the system is used with the PhysioGlove, the ECG Analysis Program is not available. The PhysioGlove ES Module I is intended to be marketed in two configurations. - Configuration 1 standard ES Model I without ECG analysis. . - . Configuration 2 - standard ES Model I with ECG analysis.

The 12 lead glove is designed to configure the ECG electrodes in a single unit for the purpose of conducting an electrocardiogram. It is for use in patients with a chest girth of 33.5 - 46.5 inches (85 - 118 cms).

The PhysioGlove is a glove that incorporates a system of Ag/AgCI electrodes for use in recording ECGs. The glove terminates in a standard 15-pin mini D-type connector. The PhysioGlove is intended to be used with the cleared PhysioGlove ES-1 software, for recording diagnostic 12-lead ECGs.

The PhysioGlove ES Model I is a reusable 12-Lead diagnostic ECG examination system. It is intended for use in resting diagnostic electrocardiograph examination of adults. It is intended for use in physician offices, hospitals, outpatient clinics, or similar settings by or on the order of a physician or similarly qualified healthcare professional. The device only provides waveform parameters for healthcare provider interpretation and does not itself provide suggested interpretations.

The PhysioGlove ES Model I is a diagnostic electrocardiograph for 12-Lead resting ECGs. The system has been tested to a variety of performance standards. The PhysioGlove ES Model I consists of an electronics data acquisition unit and software that runs on a medical grade PC. The PhysioGlove ES Model I uses a standard, FDA-cleared, 10-electrode ECG cable to obtain ECG data from the patient. The electronics performs analog processing and analog to digital conversion of a 12 lead diagnostic ECG. The digital packets from the front-end enter the PC via the USB port. The software for the PC performs a variety of functions, including patient registration, ECG display, and storage. Users may also vary ECG acquisition parameters.