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The Quantitative Sentinel (QS) System's is intended for automatic patient data management. It does this by: - (a) providing the user the ability to create and use electronic forms for entering, viewing and storing patient and facility related data (e.g. charts, forms, graphs, chalkboards, care plans, user reference manual). - (b) interfacing with other hospital information systems and medical devices for automatic data acquisition, viewing and storage with the electronic patient record. - (c) providing visual notification of when acquired fetal monitor heart rate values exceed the user defined limits for high and low fetal heart rate and poor signal quality. - (d) providing Spectra Alerts capabilities for fetal monitoring (surveillance). - (e) providing automatic computations of physiologic indexes (e.g. nutrition). - (f) providing calculations from user defined formulas (i.e. index calculator). - (g) providing the ability to record, with the patient record, fluid input and oulput information that is defined by the user. - (h) providing the ability to export patient data to relational databases for research and Quality Assurance purposes. - (i) providing the ability to archive files to a secondary or tertiary storage medium (i.e. optical disk). - (i) providing the ability to print (locally or remotely) patient records and QS database definition (e.g. item names) - (k) providing the ability to review fetal monitor data (OB-Link) remotely over the internet.

The Quantitative Sentinel (QS) System is a software application that is intended for use as clinical data management system (also referred to as a clinical information system - CIS). The primary function of the system is the management of clinical data (whether manually or automatically acquired) for the purpose of providing integrated, ready and organized access to patient and/or clinical data that would normally be provided on paper records and/or separate clinical systems/devices. The QS System serves as a decision support tool as well as an electronic medical record. The QS System operates on off-the-shelf software and hardware. The device is intended for use in a hospital/clinical environment.

QT Guard Analysis System is intended to be used in a hospital or clinic environment by competent health professionals. QT Guard Analysis System is intended to perform the analysis of simultaneously acquired 12-lead ECG for obtaining the measurements of QT interval dispersion and T wave complexity. QT-Guard Analysis Program is intended to provide only the measurements of the QT dispersion and T wave complexity and is not intended to produce any interpretation of those measurements or diagnosis. The QT dispersion and T wave complexity measurements produced by QT Guard Analysis System are intended to be used by qualified personnel in evaluating the patient in conjunction with patient's clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgment. QT Guard Analysis System is intended for adult patient populations.

QT Guard Analysis System is a software program for measuring the QT interval dispersion and T wave complexity from simultaneously acquired 12-lead ECG.

The MUSE CV is a large capacity client server based computer system that accesses, stores and manages cardiovascular information. The information can consist of measurements, text, and digitized waveforms. MUSE CV is intended to be used in a hospital environment by trained operators. MUSE CV is designed for network compatibility and interfaces with other hospital information systems through various communication protocols. MUSE CV provides the ability to serially compare/trend cardiovascular information. Use of MUSE CV is intended for accessing, storage and management of both adult and pediatric cardiovascular information.

MUSE CV is a large capacity client server based computer system that accesses, stores and manages cardiovascular information. The information can consist of measurements, text, and digitized waveforms.

This device is viewed as a component of a system. The APEX Oximeter adds modularity to Marquette's CD Telemetry System product line. The Apex Oximeter is intended for portable patient monitoring of an ambulating patient's oxygen saturation and pulse rate. This device is intended to be used by personnel trained in the use of the equipment. It is intended to be used within the hospital/facility environment.

This device is viewed as a component of a system. The APEX OXIMETER adds modularity to Marquette's telemetry product line. It is intended for portable patient monitoring of an ambulating patient's oxygen saturation and pulse rate. The oxygen saturation calculations for the Apex Oximeter is performed identically to the method used in the Nonin 8500 series hand held pulse oximeter. The oximeter generates serial communications with a custom protocol to communicate with the CD Telemetry System.

Multi-Link Cable and Lead Wire Systems are electrode cable systems used to transmit signals from patient surface electrodes to various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment. Such equipment is commonly located in hospitals, doctors offices, emergency vehicles, as well as in home use.

Multi-Link Cable and Lead Wire Systems are a reusable electrode cable systems used to transmit signals from patient electrodes to various electrocardiograph recorders / monitors for both diagnostic and monitoring purposes. This type of device is common to both the industry and to most medical establishments.

CardioSmart ST is intended to be used for resting and stress test ECG and for recording ECG in real-time without arrhythmia detection. CardioSmart ST is intended to be used by trained operators when ECG records are required in the iudgment of a physician. CardioSmart ST is not intended for use as a vital signs physiological monitor. CardioSmart ST offers no diagnostic opinion to the user. Instead, it provides interpretive statements for which the physician renders his/her own medical opinion. CardioSmart ST is not designed for intracardial use. CardioSmart ST is not intended for home use.

CardioSmart ST is a portable ECG data acquisition and recording system designed and manufactured by Marquette Hellige GmbH. CardioSmart ST allows the user to - record resting ECGs, - i measure and interpret the ECGs, - perform ECG stress tests.

Acute Cardiac Ischemia Time-Insensitive Predictive Instrument (ACI-TIPI ) Option is intended to be used in a hospital or clinic environment by competent health professionals utilizing recorded ECG data to produce a numerical score which is the predicted probability of acute cardiac ischemia (which includes unstable angina pectoris and acute myocardial infarction). Like any computer-assisted ECG interpretation program, the Marquette ACI-TIPI evaluation and probability score is intended to supplement, not substitute for the physician's decision process. It should be used in conjunction with knowledge of the patient's history, the results of a physical examination, the ECG tracing, and other clinical findings. ACI-TIPI is intended for adult patient populations.

Acute Cardiac Ischemia Time-Insensitive Predictive Instrument (ACI-TIPI ) Option is a software option for Marquette MAC-series electrocardiographs to aid the physician's decision-making process in a chest pain setting by using patient age, gender, chest pain status and ECG features to provide the predicted probability of acute cardiac ischemia (which includes unstable angina pectoris and acute myocardial infarction).

The RAC 2A adds modularity to the Marquette Eagle configured product line. It is used to house the module [SAM (Smart Anesthesia Multi-gas) module] and provides an interface to the Eagle display. The module's patient information may be displayed on the Marquette Eagle monitor. This device is intended to be used by personnel trained in the use of the equipment. It is intended to be used within the hospital/facility environment.

This device is viewed as a component of a system. The RAC 2A adds modularity to Marquette's Eagle configured product line. It is used to house the module [SAM (Smart Anesthesia Multi-gas) module] and provides an interface to the Eagle display. The RAC 2A is intended to allow the module's patient information to be displayed on the Eagle monitor display.

The Marquette Eagle 1000 (DASH 1000) Patient Monitor is a patient monitor that is designed to be used to monitor a patient's basic physiological parameters including: electrocardiography (ECG), invasive blood pressure, non-invasive blood pressure, oxygen saturation, and temperature. Optionally, the printing of information by a paper recorder may be added to the basic monitor configuration. Use of this device is intended for patient populations including: adult, pediatric, and/or neonatal.

The Marquette Eagle 1000 Patient Monitor is a patient monitoring system that is designed to be used to monitor a patient's basic physiological parameters including: electrocardiography (ECG), invasive blood pressure, non-invasive blood pressure, oxygen saturation, and temperature. The Eagle 1000 Patient Monitor is a microprocessor-based, software-driven device. The signal-acquisition and -processing technologies and the basic parts of the device software were re-used from former devices.