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CommandEP is intended for use as a medical imaging system that allows the review, analysis, communication, and media interchange of multi-dimensional digital images. It is also intended for intraprocedural use. CommandEP is designed as an additional visualization modality to assist the clinician. CommandEP indicated for use in electrophysiology (EP) procedures to assist the clinician in visualization of the heart electroanatomic data.

The SentiAR CommandEP device is a medical imaging system which allows for the review, analysis, communication, and media interchange of multi-dimensional digital images. CommandEP HMD provides a real-time, three-dimensional (3D) visualization of electroanatomic mapping system (EAMS) data (the Mixed Reality (MXR) EAMS Visualization). CommandEP is intended to be used as an adjunct device to assist the clinician in visualization of the cardiac electrophysiology procedures. Real-time multi-dimensional images are received from an Electroanatomic Mapping System (EAMS) by the touchscreen, all-in-one computer (the Model DPC02 Data Manager PC) and wirelessly transmitted to up to five (5) Head Mounted Displays (the Model HMD02 CommandEP HMD). Additional HMDs may be allocated to facilitate charging and device management. The EAMS is directly connected to the CommandEP by a wired network cable. The CommandEP Data Manager PC communicates with the CommandEP HMDs through a dedicated, encrypted Wi-Fi network provided by the Data Manager PC. Clinician users view the MXR EAMS Visualization in stereoscopic 3D using optical see-through (OST) HMDs and manipulate the MXR EAMS Visualization using hands-free gaze-dwell controls. The OST display enables clinicians to view both the conventional EAMS display and the CommandEP MXR EAMS Visualization during the procedure. The hands-free controls enable clinicians to control the device without breaking sterility and may also reduce the need to verbalize commands to a non-sterile EAMS technician. CommandEP allows a clinician user to modify the personal view of data, but does not deliver therapy, intervene with therapy, assist the clinician with therapeutic decisions, or otherwise affect the performance of any other medical device. CommandEP also provides a shared view function which allows observers or supporting staff to view the cardiac electroanatomic data, with the notated perspective of a selected HMD user, on an either 1) an HMD or 2) a conventional PC display provided by the Data Manager PC (the Spectator Display) to facilitate team communication. The intended physician user of the CommandEP device is an electrophysiologist. The electrophysiologist performs procedures in a cardiac electrophysiology laboratory, which is a sterile professional healthcare environment. All components of the CommandEP device are non-patient contacting device and are provided non-sterile.