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The T-Wave Alternans (TWA) Algorithm Option is to be used in a hospital, doctor's office, or clinic environment by competent health care professionals for recording ST-T wave morphology fluctuations for patients who are undergoing Cardiovascular disease testing. The T-Wave alternans analysis is intended to provide only the measurements of the fluctuations of the ST-T-waves. The T-Wave alternans measurements produced by the T-Wave Alternans analysis are intended to be used by qualified personnel in evaluating the patient in conjunction with the patients clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgment. No interpretation is generated.

T-Wave Alternans (TWA) Algorithm Option is a software algorithm that runs on GE Medical Systems Information Technologies' electrocardiographs.

The intended use of the SEER Light Compact Digital Holter Recorder is to acquire ambulatory 2 or 3 channels of ECG signal from the chest surface of pediatric or adult patients for no longer than 24 hours. The device stores this data along with patient demographic information to on board flash memory. It does not perform any analysis on the ECG data. The SEER Light Compact Digital Holter Recorder is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.

The SEER Light Compact Digital Holter Recorder is designed to acquire ambulatory 2 or 3 channels of ECG signal from the chest surface for no longer than 24 hours. The device stores the acquired ECG data in its on-board 32 megabytes of flash memory. Additionally, the SEER Light controller downloads patient demographic information into the SEER Light recorder and checks the signal quality of the ECG data at hookup time via isolated, infra-red communications. At the end of the recording the SEER Light controller is connected to the SEER Light recorder by cable and the stored ECG data is transferred to it and onto a standard compact flash memory card.

AccuSketch Cardiac Quantitative Analysis System w/ Advanced Analysis Components is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. AccuSketch is intended to provide and document an objective quantification of coronary artery stenosis and measurement and quantification of left ventricular function. Also provided is the ability to digitize and store video images and the ability to interactively annotate and report current and post procedural patient cardiac status.

The AccuSketch Cardiac Quantitative Analysis System w/ Advanced Analysis Components is a PC based software system comprised of 4 individual programs used to view, capture/print, analyze and annotate images from cardiac catheterization procedures. AccuSketch is offered as a complete turn-key system or can be ported into other GE cardiac image devices for image analysis. The AccuSketch is a Personal Computer (PC) based software system designed to be permanently installed in a hospital in or near the cardiac catheterization laboratory. AccuSketch is comprised of four individual programs responsible for a specific function. Their purpose is to view, capture/print, analyze and annotate images from cardiac catheterization procedures. The CardioTree is an editable coronary tree tool used to electronically annotate and document the anatomy of the patient's vessels.

Indicated for use in data collection and clinical information management through networks with independent bedside devices. The Unity Network ID is not intended for monitoring purposes, nor is the Unity Network ID intended to control any of the clinical devices (independent bedside devices/ information systems) it is connected to.

The Unity Network ID system communicates patient data from sources other than GE Medical Systems Information Technologies equipment to a clinical information system, central station, and/or GE Medical Systems Information Technologies patient monitors. The Unity Network ID acquires digital data from eight serial ports, converts the data to Unity Network protocols, and transmits the data over the monitoring network to a Unity Network device such as a patient monitor, clinical information system or central station.

The Dash 3000/4000 Patient Monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash is designed as a bedside, portable, and transport monitor that can operate in all professional medical facilities and medical transport modes including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, freestanding surgical centers, and other alternate care facilities, intra-hospital patient transport, inter-hospital patient transport via ground vehicles (i.e., ambulance, etc.) and fixed and rotary winged aircraft, and pre-hospital emergency response. Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, oxygen, and anesthetic agents as summarized in the operator's manual. The Dash 3000/4000 Patient Monitor is also intended to provide physiologic data over the Unity network to clinical information systems and allow the user to access hospital data at the point-of-care. This information can be displayed, trended, stored, and printed. The Dash 3000/4000 Patient Monitor was developed to interface with non-proprietary third party peripheral devices that support serial data outputs.

The Dash 3000/4000 Patient Monitor is a device that is designed to be used to monitor, display, and print a patient's basic physiological parameters including: electrocardiography (ECG), invasive blood pressure, non-invasive blood pressure, oxygen saturation, temperature, impedance respiration, end-tidal carbon dioxide, oxygen, nitrous oxide and anesthetic agents. Other features include arrhythmia, cardiac output, cardiac and pulmonary calculations, dose calculations, PA wedge, ST analysis, and interpretive 12 lead ECG analysis (12SL). Additionally, the network interface allows for the display and transfer of network available patient data.

MAC-LAB System: The MAC-LAB System is intended for use under the direct supervision of a licensed healthcare practitioner to monitor and/or calculate and/or record cardiovascular data from patients as they undergo cardiac catheterization. Cardiovascular data may be manually entered or acquired via an interfaced GE Medical Systems Information Technologies TRAM modules (k921669), MUSE cardiovascular system and other interfaced information systems. Data includes: ECG waveforms, heart rate, pulse oximetry (SpO2), respiration rate, valve gradients and areas, cardiac output, hemodynamic measurements, invasive and noninvasive blood pressure, procedural information, and optional intracardiac electrocardiogram (IECG). This information can be displayed, trended, stored, printed and/or transmitted to other networked hospital information systems. The system does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities. CardioLab EP System: The CardioLab EP System is intended for use under the direct supervision of a licensed healthcare practitioner to acquire, filter, digitize, amplify, display, and record electrical signals obtained during electrophysiological studies and related procedures conducted in an electrophysiological laboratory. Signal types acquired include ECG signals, direct cardiac signals, and pressure recordings. Physiological parameters such as diastolic, systolic, and mean blood pressure, heart rate, and cycle length may be derived from the signal data, displayed and recorded. The system allows the user to monitor the acquisition of data, review the data, store the data, perform elementary caliper-type measurements of the data, and generate reports on the data. Additionally, the system may acquire, amplify, display, and record data received from other medical devices typically used during these procedures, such as imaging devices and RF generators. The system does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities. The ComboLab System The ComboLab is the combination of both CardioLab EP and MAC-LAB allowing the user to run the CardioLab EP and MAC-LAB modes, though only one mode may be used at a time (CardioLab EP for electrophysiology lab cases and MAC-LAB for catheterization lab cases). The system does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities. The MAC-LAB / CardioLab EP and ComboLab systems do not control the delivery of energy, administer drugs, perform any life-supporting or life-sustaining functions, or analyze physiological data or other data acquired during procedure.

The MAC-LAB System is a microprocessor based data acquisition system used during cardiac catheterization procedures. The MAC-LAB system, via various models of the GE Medical Systems Information Technologies TRAM module (K921669) and amplifier module, acquires patient data which may include surface ECG, invasive and non-invasive blood pressure, blood oxygen saturation via pulse oximetry, respiration, and temperature. The TRAM module is housed in a dedicated front end chassis called the remote acquisition case (RAC). The MAC-LAB System joins together the TRAM module and amplifier module with computer processors, software, high resolution display monitors, power supply, laser printer, keyboard and mouse. Digital data is transmitted, via cable, from the TRAM module and/or amplifier module to the computer for processing. Major functions of the software include data acquisition and display, data storage, reporting of data, and transmission of data to other information systems via LAN. The CardioLab EP System is a microprocessor based data acquisition system used during electrophysiology procedures to acquire ECG, intracardiac signals, and pressure signals via amplifier module. Digital data is also acquired from other devices such as RF generators, fluoro video systems and the GE Medical Systems Information Technologies TRAM module. The ECG, intracardiac and pressure data are acquired by an amplifier that is connected to the patient by third-party devices such as ECG leadwires and catheters. The amplifier filters, amplifies, digitizes and transmits the data to the computer via fiber optic cable. The computer stores the data on optical disks, displays the data on the video monitors, allows the user to perform basic signal measurements, and prints out waveforms on a laser printer or continuous paper recorder. Major functions of the software include data acquisition and display, data storage, reporting of data, and transmission of data to other information systems via LAN. The product will be available in three configurations: CardioLab EP application only, MAC-LAB application only, or combination of both CardioLab EP and MAC-LAB applications. The 'CardioLab EP only' configuration only allows the user to run the CardioLab EP mode. The 'MAC-LAB only' configuration only allows the user to run the MAC-LAB mode. The combination of both CardioLab EP and MAC-LAB allows the user to run the CardioLab EP and MAC-LAB modes, though only one mode may be used at a time (CardioLab EP for electrophysiology lab cases and MAC-LAB for catheterization lab cases).

The Unity® IS Patient Viewer is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the Unity® IS Patient Viewer is to provide a remote view of physiological parameter data on adult, pediatric and neonatal patients within a hospital or facility providing patient care. The Unity® IS Patient Viewer is NOT intended for primary monitoring but is to be used in conjunction with the bedside monitor. The Unity® IS Patient Viewer is intended to provide near-real-time physiological data and graphical trends for all monitors connected to the Unity Network to secure nurse and physician personal computers (local and remote).

The Unity® IS Patient Viewer provides remote access to waveform, parameter data and trend data at a web browser on a standard personal computer. The server resides on the hospital's intranet and remote access is gained through secured access to the hospital intranet. The data relayed from the patient monitors over the Unity® MC network includes patient name, unit and bed name, parameter data, and waveform data monitored by the bedside monitors. The user can view up to nine waveforms from the Unity® MC network as well as the parameter information in near real-time. Neither alarm messages nor parameter status messages are displayed. The Unity® IS Patient Viewer system provides a secondary view of patient information, and is NOT a patient monitoring device. The clinician is instructed to always reference the primary bedside monitor before making any patient care decisions. In the event that data is not available via the Unity® IS Patient Viewer, the clinician is instructed to obtain the data from the primary bedside monitor. The Unity® IS Patient Viewer system consists of a 1U Rack Mountable Server with server and client software packages. The two software pieces reside on the 1U Rack Mountable Server, which is a standard hardware server platform for hosting network applications. The hardware server is connected to two networks: Unity® Network and the hospital's Intranet. The Unity® Network is a currently marketed proprietary network connecting patient monitors. The hospital's Intranet refers to the existing Local Area Network (LAN) within the hospital that connects a number of personal computers (PCs).

The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The ApexPro Telemetry System is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered. The physiological parameters monitored include ECG, non-invasive blood pressure and SpO2. The ApexPro Telemetry System is intended to provide ECG data via Ethernet to the computer platform for processing. The ApexPro is also intended to provide physiologic data over the Unity network to clinical information systems for display.

The ApexPro Telemetry System is composed of six major components: • The patient worn data acquisition transmitters • The receiver antenna system infrastructure • The receivers • The receiver subsystem • A computer platform running the ApexPro Telemetry Application • A computer platform running a central station application (which may be the same computer platform running the ApexPro Telemetry Application)

The PatientNet™ System is intended to collect and analyze patient data from ECG ambulatory The Pational - Syctorn - Jeading manufacturers' bedside monitors and ventilators anywhere in a healthcare facility and distributes the data to locations throughout the facility. Monitoring of Recognized Conditions: -An environmentally controlled clinical setting that has multiple patients using any combination of ECG leads, bedside monitors, or ventilators. -Hospital areas that have the capability of installing hardwire paths to the Central Monitoring Station from the rooms or areas where bedside monitors or ventilators operate. -Clinical areas that have the capability of installing 174-216 MHz radio systems (or alternate frequency bands approved by the FCC) to communicate via RF. The information from the ECG leads, bedside monitors or ventilators is transferred via an RF transmitter to the Central Monitoring Station. Target Population: Those patients who are connected through PatientNet™ Monitoring System via ambulatory ECG transmitters, bedside monitors, or ventilators.

The modified PatientNet™ Monitoring System performs patient monitoring using PatientNet™ rne moulhou Patient for radio transmitters connected directly to bedside monitors or athbuittory fudio transmitors with similar physiological parameters, and to ventilators that have digital outputs.

The Solar 8000M System is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in the use of the equipment. The Solar 8000M is a multiparameter physiological patient monitoring system intended for use on adult, pediatric and neonatal patients, within a hospital or facility environment. The Solar 8000M System is capable of monitoring electrocardiogram, non-invasive pressure, pulse, invasive blood pressure, blood temperature, cardiac output, respiration, pulse oximetry, venous O2 saturation, Transcutaneous O2 and CO2 respiratory mechanics, and/or (for adult and/or pediatric patients) anesthetic agent concentrations, impedance cardiography, electroencephalography and bispectral index. O2 and CO2 concentrations are available for neonates not under anesthesia. Information can be displayed, trended and stored in the monitor from a variety of peripheral devices. The Solar 8000M System is also intended to provide physiologic data over the UNITY Tu network. The Solar 8000M System was developed to interface with third party peripheral devices that support serial and/or analog data outputs.

The Solar 8000M System includes the following basic components: Solar 8000M processing unit a display TRAM-rac housing acquisition module(s) keypad and/or remote control Additional, optional components include: Clinical Information Center (central station) Remote display digital writer or printer TRAM-Net interface adapter(s) Octanet connectivity device Remote Alarm Box