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The AlarmView™ Wireless Data Network System is for use in real-time monitoring of routine patient status and alarm events on medical devices. It serves as a parallel, redundant mechanism to inform the clinical staff of patient events. The AlarmView™ System provides a secondary means of annunciating and displaying patient alarm information to mobile healthcare professionals. The AlarmView™ System is limited to use by qualified medical professionals who have been trained on the use of the device. It is intended for use in hospital type environments and is not for home use. The AlarmView™ System is to supplement and not replace any part of the current device monitoring procedure. The AlarmView™ System is not considered in and of itself to be diagnostic without skilled interpretation and does not replace physician's care.

The modified AlarmView™ Wireless Data Network System is a low powered local area wireless paging system that provides secondary annunciation of primary medical device alarms via wireless communication devices carried by healthcare professionals.

The FlexView™ Clinical Monitoring System is intended for use as a secondary annunciation of compatible primary medical device alarms. The FlexView™ Clinical Monitoring System is for use as an accessory to primary medical devices and is currently compatible with puise oximeters, infusion pumps and ventilators. The FlexView™ Clinical Monitoring System is to supplement and not replace any part of the current primary medical device monitoring procedure. The FlexView™ Clinical Monitoring System is for use by healthcare professionals trained in the primary medical devices that are being monitored. The FlexView™ Clinical Monitoring System is not considered to be diagnostic without skilled interpretation and does not replace physician's care. The Flex\lew™ Clinical Monitoring System is for use with patient populations being monitored by healthcare professionals utilizing compatible pulse oximeters, infusion pumps and ventilators. The FlexView™ Clinical Monitoring System is for use in healthcare facilities such as hospitals, or free standing surgical centers.

The FlexView™ Clinical Monitoring System is a PC based central monitoring station used to acquire information from primary medical devices (pulse oximeters, infusion pumps and redisplay it on a single monitor in a central location. It allows the remote monitoring of multiple medical devices simultaneously and provides secondary annunciation of the alarms from the primary medical devices.

The AlarmView™ Wireless Data Network System is for use in real-time monitoring of routine patient status and alarm events on medical devices. It serves as a parallel, redundant mechanism to inform the clinical staff of patient events. The AlarmView™ System provides a secondary means of annunciating and displaying patient alarm information to mobile healthcare professionals. The AlarmView™ Wireless Data Network System is limited to use by qualified medical professionals who have been trained on the use of the device. It is for use in hospital type environments and is not for home use. The AlarmView™ Wireless Data Network System is to supplement and not replace any part of the current device monitoring procedure. The AlarmView™ Wireless Data Network System is not considered in and of itself to be diagnostic without skilled interpretation and does not replace physician's care.

The modified AlarmView™ Wireless Data Network System is a low powered local area wireless paging system that provides secondary annunciation of primary medical device alarms via wireless communication devices carried by healthcare professionals.

This device is intended for use in real-time monitoring of routine patient status and alarm events on medical devices. It serves as a parallel, redundant mechanism to inform the clinical staff of patient events. It is intended to be a secondary means of annunciating and displaying patient alarm information to mobile healthcare providers. AlarmView is limited to use by qualified medical professionals who have been trained on the use of the device. It is intended for use in hospital and hospital type environments and is not for home use. AlarmView is intended to supplement and not to replace any part of the current device monitoring procedures. AlamView is not considered in and of itself to be diagnostic without skilled interpretation and does not replace physician's care. AlarmView is currently validated for use with the N-x9y and N-3x00 data protocols.

AlarmView™ is a paging system that interfaces with a primary patient clinical device in order to provide a secondary means of annunciating and displaying patient alarm information to mobile health care providers. AlarmView reads the patient information from the output data port and does not change the primary monitor in any way. It formats the patient information into a message that can be transmitted to a pager carried by mobile health careqivers. AlarmView does not diagnose alarms. AlarmView consists of the AV Transmitter, AV Pager, and the AC PDA (Personal Digital Assistant) used for administration.

This device is indicated for use in real-time monitoring of routine patient status and alarm events. StatView is limited to use by qualified medical professionals who have been trained on the use of the device. StatView is not intended for home use. StatView™ is a paging system that interfaces with primary patient monitoring systems (PPMS) to serve as a parallel, redundant mechanism to inform the clinical staff of patient events. It is intended to be a secondary means of annunciating and displaying patient alarm information to mobile healthcare providers. StatView™ has been validated for use with the following networks: Héwlett-Packard CareNet, GE Marquette Medical Unity, and Siemens Medical Systems Infinity.

StatView™ System is a paging system that interfaces with primary patient monitoring systems (PPMS) in order to provide a secondary means of annunciating and displaying patient alarm information to mobile health care providers. StatView interfaces with the PPMS and reads the same alarm information that the PPMS uses, then formats that information into a message that can be transmitted to the receivers carried by mobile health caregivers. Although StatView reads the same alarm information that the PPMS LAN sends, it does not change it or modify it in any way. StatView does not diagnose alarms but transmits what the PPMS determines to be an alarm. StatView consists of the StatView Server (WT Server), StatView Transmitter, and StatView Receiver. In addition to the capabilities of the previous version of StatView (predicate device), users of the StatView system can send pre-programmed text messages that can be easily selected when initiating a text page as well as scheduling text messages. Semi-automatic mode is used for facilities that with their monitoring technicians to continue to filter the alarm traffic sent to the mobile caregivers.

The Cardio-Pager™ System described in this submission is a paging system that interfaces with Primary Patient Monitoring Systems in order to provide a secondary means of annunciating and displaying patient alarm information to mobile health care providers. This pager is intended to serves as a parallel, redundant mechanism to inform the clinical staff of patient events. This device is indicated for use in real-time monitoring of routine patient status and alarm events. The Cardio-Pager™ is limited to use by qualified medical professionals who have been trained on the use of the device. It is intended for use only in a hospital environment. The device has been validated for use with the Marquette Unity Network and the Hewlett-Packard Systems CareNet System.

The Cardio-Pager™ System (also referred to as StatView) is a secondary alarm notification system that transmits text and waveform data from patient monitoring devices to a graphical pager worn by a trained professional in a hospital environment. The system monitors the patient monitoring devices for alarm conditions, and responds by transmitting a page that includes text and waveform information from the patient. This system is not intended to be a primary alarm enunciator. The Cardio-Pager™ System alerts and informs the clinician about critical patient alarms without requiring them to be at or near the bedside or central monitors. The system can also provide periodic updates of heart rate and waveform data at intervals established by the caregivers. The primary components in the Cardio-Pager™ System are the Critical-Server (also referred to as the WT Server) and the Transmission Subsystem. The server is a standard IBM-compatible PC that connects directly to the patient-monitoring network. The Transmission Subsystem consists of the paging transmitter, a standard serial-to-Ethernet converter, and the Cardio-Pager™ receiver units. Software modules in the Critical-Server acquire patient information from the patient monitoring network, manage the initiation of paging messages, convert the data to proper format for transmission to the paging transmitter, and send the message to the paging transmitter via a LAN. The paging transmitter then sends the page, using standard POCSAG paging protocol. One or more of the Cardio-Pager™ receiver units may receive the page. Addition of the Cardio-Pager™ System to the patient monitoring computer network does not in any way affect, modify, or interrupt the normal operation of the hospital patient monitoring system.

The RhythmStat XL System is indicated for use in the diagnostic evaluation and recording of ECG waveforms from a cardiac event recorder. It is intended to provide remote access to ECG data by transtelephonic transmission from an ambulatory cardiac event monitor to the portable PSION palmtop computer with RhythmStat XL software, where the ECG waveforms are demodulated, recorded, displayed and stored.

The RhythmStat XL System is a telephone electrocardiograph (ECG) receiving system used for recording and reporting of ECG data from a cardiac event recorder. The System has three main components: - . A commercially available cardiac event recorder such as the Micromedical Industries BIOLOG or the Instromedix® Heart Card™, that conditions and transmits ECG data in the form of a frequency-modulated acoustic waveform to the PSION Series 3 palmtop computer: - Two proprietary software programs, contained in the commercially available PSION Series 3 . palmtop computer, that 1) recondition the received signal format and display the signal to the physician on the computer screen, then 2) transmit the ECG data, along with the physician's comments, from the PSION palmtop computer to the Reporting Server via modem; and - . The Data Critical Reporting Server that accepts the ECG data and commentary and generates a printed report that is automatically transmitted to the physician's office via fax.