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The IMRACT Pager System is intended to be used for the annunciation of events within a zone coverage area that is secondary to the primary care that is provided. Primary care via the central station, patient bedside monitor, or telemetry system remains unchanged. This device is intended to be used within the hospital/facility environment.

The IMPACT pager is intended for the annunciation of events to provide zone information that is secondary to the primary care provided. It provides specific information within a zone and alerts or draws an identified individual's aftention to a defined patient condition in a timely manner. Primary care via the central station, telemetry system, or patient bedside monitor remains unchanged by the addition of the IMPACT pager.

The Marquette Eagle 4000 Patient Monitor is a multi-parameter patient monitoring system that is cleared to market as part of Marquette's wired Unity network. The Marquette Eagle 4000 Patient Monitor is now indicated for use on Marquette's wireless LAN. Wireless LAN is a method of communicating to the Marquette Unity Network using a wireless connection. This capability: ~provides identical networking function to standard Ethernet; ~permits integration to the network without physical connection to the Ethernet wall plate. This device is viewed as a technology change and can be used with various other Marquette devices. Marquette has clearances for various patient monitors and its central station which are part of its wired Unity network. The intended patient population is limited to the same population as the device that the technology is being used with. This device should be used by people who are trained in the use of the equipment. This device is intended to be used within the hospital / facility environment.

The Marquette Eagle 4000 Patient Monitor is a multi-parameter patient monitoring system that is cleared to market as part of Marquette's wired Unity network. The Marquette Eagle 4000 Patient Monitor is now indicated for use on Marquette's wireless LAN. Wireless LAN is a method of communicating to the Marquette Unity Network using a wireless connection. This capability: ~provides identical networking function to standard Ethernet; ~permits integration to the network without physical connection to the Ethernet wall plate.

PHi-Res is a software option for Marquette ECG analysis systems for high resolution P wave analysis. PHi-Res is intended to be used in a hospital or clinic environment by health care professionals for recording low amplitude/high frequency components of the surface electrocardiogram for P wave analysis. PHi-Res analysis is only intended to provide the measurements of the signal averaged P wave and is not intended to provide any interpretation of those measurements or any kind of diagnosis. The P wave measurements provided by PHi-Res analysis 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. PHi-Res is intended for patient populations including adult and pediatric.

PHi-Res analysis is a software option for Marquette MAC-series electrocardiographs for high resolution P wave analysis.

CardioServ is intended to be used for the emergency resuscitation of cardiac arrest victims and clinical cardiac dysrhythmia. CardioServ is intended to be used by trained operators CardioServ is designed for external and internal defibrillation (including cardioversion) CardioServ is capable of monitoring the heart rate with adjustable alarm limits. CardioServ is designed for external pacing with adjustable current and frequency. The intended use of CardioServ is identical to the intended use of the predicate devices.

CardioServ is a portable defibrillator with ECG monitor, built-in recorder, and the capability of external pacing with adjustable current and frequency.

Responder 2500 is intended to be used in a hospital environment by emergency personnel in evaluating and treating life-threatening arrhythmias. ♦ Responder 2500 is intended to be used by trained operators ♦ Responder 2500 is designed for external and internal defibrillation (including cardioversion) ♦ Responder 2500 is capable of monitoring the heart rate with adjustable alarm limits. ♦ Responder 2500 is designed for external pacing with adjustable current and rate.

Responder 2500 and Cardiac Care System is an emergency cardiac monitor/defibrillator with an external pacing option.

The pager is intended for the annunciation of events to provide zone information that is secondary to the primary care provided. It provides specific information within a zone and alerts or draws an identified individual's attention to a defined patient condition in a timely manner. Primary care via the central station, telemetry system, or patient bedside monitor remains unchanged by the addition of a pager.

This device is commonly known as a pager and an alarm display unit.

The Marquette Eagle 4000 Patient Monitor is designed to monitor and display patient data. Its design allows the operator to adjust parameter alarm settings that would audibly and visually notify the operator when a violation occurs. The option is provided for printing of information by a paper recorder. Use of the Marquette Eagle 4000 Patient Monitor is intended for patient populations including: adult, pediatric, and/ or neonatal. Use of the Marquette Eagle 4000 Patient Monitor is not recommended for use in patient's home or residence, during patient transport, or when it has not been ordered by a physician or other qualified medical personnel. Use of the Marquette Eagle 4000 Patient Monitor is intended for operating room (OR), post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care. These departments are typically located in hospitals or may be located in outpatient clinics or free standing surgical centers. It is intended for use by physicians, physician assistants, registered nurses, certified registered nurse anesthetists, or other hospital personnel trained in the use of the equipment.

The Marquette Eagle 4000 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, temperature, respiration, apnea detection, pulse rate, cardiac output, and full arrhythmia analysis. The device now includes Marquette's 12 lead ECG Analysis program (commonly referred to as 12 SL).

CardioServ is intended to be used for the emergency resuscitation of cardiac arrest victims and clinical cardiac dysrhythmia. ♦ CardioServ is intended to be used by trained operators ♦ CardioServ is designed for external and internal defibrillation (including cardioversion) ♦ CardioServ is capable of monitoring the heart rate with adjustable alarm limits. ♦ CardioServ is capable of monitoring the saturation of O₂ with adjustable alarm limits. The intended use of CardioServ is identical to the intended use of the predicate devices.

CardioServ S is a portable defibrillator with ECG monitor, built-in recorder, and the capability of monitoring the saturation of O₂ with adjustable alarm limits.

The Marquette Eagle 3000 Patient Monitor is designed to monitor and display patient data. Its design allows the operator to adjust parameter alarm settings that would audibly and visually notify the operator when a violation occurs. The option is provided for the printing of information by a paper recorder. Use of the Marquette Eagle 3000 Patient Monitor is intended for patient populations including: adult, pediatric, and/ or neonatal. Use of the Marquette Eagle 3000 Patient Monitor is not recommended for use in patient's home or residence, during patient transport, or when it has not been ordered by a physician or other qualified medical personnel. Use of the Marquette Eagle 3000 Patient Monitor is intended for operating room (OR), post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care. These departments are typically located in hospitals or may be located in outpatient clinics or free standing surgical centers. It is intended for use by physicians, physician assistants, registered nurses, certified registered nurse anesthetists, or other hospital personnel trained in the use of the equipment.

The Marquette Eagle 3000 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, temperature, and end tidal carbon dioxide (EtCO2). PA Wedge is also available. The Eagle 3000 Patient Monitor is a factory configured or fixed-parameter patient monitoring device. Options which allow for the monitoring of invasive blood pressure and the printing of information by a paper recorder may be added to the basic monitor configuration at the factory prior to shipment to the customer. The Eagle 3000 Patient Monitor has NOT been designed as a modular patient monitoring device which allows the addition and deletion of monitoring parameters at the point-of-use. The Eagle 3000 Patient Monitor has NOT been designed as a transport monitor. Therefore, no battery power feature or option has been included with this device.

The Marquette Eagle 3000 Patient Monitor is designed to monitor and display patient data. Its design allows the operator to adjust parameter alarm settings that would audibly and visually notify the operator when a violation occurs. The option is provided for the printing of information by a paper recorder. Use of the Marquette Eagle 3000 Patient Monitor is intended for patient populations including: adult, pediatric, and/ or neonatal. Use of the Marquette Eagle 3000 Patient Monitor is not recommended for use in patient's home or residence, during patient transport, or when it has not been ordered by a physician or other qualified medical personnel. Use of the Marquette Eagle 3000 Patient Monitor is intended for operating room (OR), post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care. These departments are typically located in hospitals or may be located in outpatient clinics or free standing surgical centers. It is intended for use by physicians, physician assistants, registered nurses, certified registered nurse anesthetists, or other hospital personnel trained in the use of the equipment.

The Marquette Eagle 3000 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, temperature, and arrhythmia analysis. The Eagle 3000 Patient Monitor is a factory configured or fixed-parameter patient monitoring device. Options which allow for the monitoring of invasive blood pressure and the printing of information by a paper recorder may be added to the basic monitor configuration at the factory prior to shipment to the customer. The Eagle 3000 Patient Monitor has NOT been designed as a modular patient monitoring device which allows the addition and deletion of monitoring parameters at the point-of-use. The Eagle 3000 Patient Monitor has NOT been designed as a transport monitor. Therefore, no battery power feature or option has been included with this device.