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The EP-4 Cardiac Stimulator is indicated for use during clinical cardiac electrophysiology procedures. The EP-4 Cardiac Stimulator is intended to be used for diagnostic electrical stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachyarrhythmias, and measurements of electrical conduction.

The EP-4 Cardiac Stimulator consists of a touch-screen computer, an AC-powered stimulation module, which provides electrical stimulation to the heart during electrophysiology case studies. The EP-4 consists of a touch-screen computer that controls a two- or four-channel AC-powered stimulation module, and a keyboard. The stimulator is capable of performing single channel, simultaneous, or sequential stimulation at programmed output settings using existing/predicate programmed protocols. The device is independent and self-contained, with the exception of marker outputs and an external sync input connector. It can be configured as a stand-alone system or in conjunction with the EP-WorkMate™ Recording System. It may also be used with other EP recording systems.

The ViewMate® System is intended to be used to visualize cardiac structures and blood flow within the heart. The ViewMate® System is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures and blood flow within the heart.

The ViewMate® System is a portable, computerized, ultrasound imaging system used to display and capture intracardiac ultrasound images. The ViewMate® System is comprised of three components: ViewMate® console, patient isolation module and the ViewFlex® PLUS ultrasound catheter. The ViewMate® ultrasound console comprises a personal computer (PC), ultrasound imaging beam former and a digital frame grabber with storage. The system software is used to control imaging modes, image quality, image acquisition, storage, and retrieval of patient records (i.e., images, ECG, and notes). The system software enables multiple imaging modes: two dimensional (B mode and color Doppler) and time-motion mode (spectral Doppler/puise wave Doppler and M Mode) Additional software functionality includes zoom, labeling, image storage, retrieval and review. ViewMate® may be used in interventional cardiology, specifically in the interventional EP laboratory. The ViewMate® connects with an ultrasound catheter called ViewFlex® PLUS that is inserted into the heart via intravascular access. The ViewFlex® PLUS catheter is a single use, temporary, intracardiac ultrasound catheter indicated for use in adult and adolescent pediatric patients. The catheter shaft is 9 French, approximately 90 cm long, constructed of radio-opaque tubing. The catheter offers bi-directional steerability that can be manipulated with one hand. The catheter consists of a 64-element linear phased array, wideband transducer with an imaging frequency range of 4.5 MHz to 8.5 MHz, user-selectable magnification, 86° viewing angle on the ViewMate® I system and a viewing angle of 90° on the ViewMate® II system.

The ViewMate® System is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures and blood flow within the heart.

The ViewMate® System is a portable, computerized, ultrasound imaging system used to display and capture intracardiac ultrasound images. The ViewMate® System illustrated in Figure 1 is comprised of three components: ViewMate® console, patient isolation module and the ViewFlex™ ultrasound catheter.

The EP-WorkMate® is intended to be used with an EP-3 [K935590] or EP-4 {K0401442] stimulator for diagnostic electrical stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachy-arrhythmias measurements of electrical conduction. NurseMate™ with Physio Module is indicated for use during clinical electrophysiology procedures.

NurseMate™ with Physio Module is a simple modification to EP-WorkMate® with NurseMate™ that allows data from an OEM (Original Equipment Manufacturer) physiologic monitoring device (connected to NurseMate™) to be logged into the current EP-WorkMate® database. The benefit of this product is reduced manual data entry and improved data management. NurseMate™ with Physio Module PC workstation is connected to the EP-WorkMate® system; it may also be connected to an OEM physiologic monitor. Interconnection of NurseMate™ with Physio Module to a physiologic monitor is accomplished using a serial data cable. Use of an OEM physiologic monitoring device is not affected in any way by integration with NurseMate™; users follow the monitor's IFU and operate the device in accordance with its intended use.

MapMate™ is indicated for use during clinical electrophysiology procedures.

This application describes a modification to the EP-WorkMate® system that will be offered as an option to customers under the name MapMate™. MapMate™ is comprised of a software module and an electronic interconnection between the EPMedSystems EP-WorkMate® and the BioSense Webster CARTO™ XP Navigation System computer. When the MapMate™ option is utilized, clinicians enter patient data in one system instead of two. A procedure log is created containing the list of map points along with the EP signals. Therefore, valuable time and attention are conserved in the busy EP lab enabling clinicians to focus on the EP case.

NurseMateTM is indicated for use during clinical electrophysiology procedures.

This application describes a modification to the EP-WorkMate® computer that will be offered as an option to customers under the name NurseMate™. NurseMate™ is a PC (Personal Computer) workstation that when connected to the EP-WorkMate® system can be used for real-time patient charting, physiologic monitoring, and data analysis during electrophysiology (EP) studies.

The EP-4 Clinical Stimulator is intended to be used for diagnostic electrical Stimulation of refractory measurements, initiation and termination of tachyarrhymias, and measurements of electrical conductions.

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The EP Deflectable Catheters are designed for one time single patient use for temporary use in electrophysiology studies. Models can be use in conjunction with EPMedSystems' EP Workmate.

EP Deflectable Catheters

The EP-4 Clinical Stimulator is intended to be used for diagnostic electrical Stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachyarrhymias, and measurements of electrical conductions,

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The ViewMate System is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures and blood flow within the heart.

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