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LifeStream 5 is a stand alone, prescription-based software program designed to operate in a clinical setting by healtheare professionals. It consists of a hosted web server, a hosted database server and two types of client interfaces - one that is provided by Windows client and one that is provided by a web client interface. LifeStream software's intended use is to retrospectively receive, display and store monitored vital signs parameters and related data. Such data includes patient blood pressure (NIBP), oxygen saturation (SpO2), weight, blood glucose, temperature, dispensed medicine, ECG, peak flow, prothrombin time and retrospective PERS messages. LifeStream retrospectively displays the data, user-defined data alerts for review and interpretation by a healthcare professional. LifeStream is not intended for emergency use or real-time monitoring.

LifeStream 5 is a stand alone, prescription-based software program designed to operate in a clinical setting by healthcare professionals. It consists of a hosted web server and two types of client interfaces, one that is provided by Windows client and one that is provided by a web client interface. LifeStream 5, like the predicate LifeStream 4.0, is configured to accept patient data that is acquired periodically and displayed retrospectively from Honeywell HomMed Patient Monitors (e.g. Genesis Touch). LifeStream 5 can also interface with 3nd party compatible medical device data systems (e.g. Govsphere TV). LifeStream 5 has the same intended use as the predicate, LifeStream 4.0. LifeStream 5, like LifeStream 4.0 is not intended for emergency use or real-time monitoring. Both are designed to retrospectively receive, display and store scheduled vital sign parameters and related data. Such data includes patient blood pressure (NIBP), oxygen saturation (SpO2), weight, blood glucose, temperature, ECG, peak flow, prothrombin time and retrospective PERS messages.

The Honeywell HomMed Genesis Touch™ Retrospective Physiological Monitoring System is designed to retrospectively monitor vital signs include noninvasive blood pressure. pulse oximetry, pulse rate, weight, temperature, blood sugar, prothrombin time/international normalized ratio (PT/INR), peak expiratory flow (PEF) and forced expiratory volume (FEV1). The Genesis Touch Retrospective Physiological Monitoring System collects; displays and transmits vital signs measurements from commercially available medical devices designed for home use. Collected measurement data from the Genesis Touch System can then be transmitted via a communication module to a central viewing station where the data can be viewed and analyzed by a healthcare professional. The Genesis Touch Retrospective Physiological Monitoring System is intended for home use by patients and caregivers or in a healthcare related environment by healthcare providers. The Genesis Touch Retrospective Physiological Monitoring System is not intended for emergency use or real-time monitoring and does not have auditory or visual alarms for out-oflimit parameters.

The modified Honeywell HomMed Genesis Touch™ Retrospective Physiological Monitoring System (Genesis Touch 10 System) is a vital signs monitoring station. The modified Genesis Touch System is a proprietary software application running on a dedicated software/commercially available tablet platform with touch screen; Wi-Fi, Bluetooth and video capability. The modified Genesis Touch System uses text and voice prompts to collect users' vital signs information from paired Bluetooth noninvasive medical device peripherals, such as blood pressure, pulse oximetry, pulse rate, weight, temperature, blood sugar, and allows for manual entry of blood sugar, prothrombin time/international normalized ratio (PT/INR), peak expiratory flow (PEF) and forced expiratory volume (FEV1). The encrypted data is automatically or at the user's discretion, forwarded to a remote central monitoring station (Honeywell HomMed LifeStream Management Suite) for retrospective review by healthcare providers. LifeStream Management Suite, a Windows-based application interface is used by the healthcare provider for the remote configuration of all the Genesis monitors, triaging of patient data, trending of clinical information, and the opportunity to provide preventative patient care. The modified Genesis Touch System also asks the user disease specific symptom management questions and provides reminder information, just like the predicates Genesis DM and Genesis Touch System. Both the modified Genesis Touch System and predicate Genesis Touch System, offer animated video instructions and optional one-touch, video-based communication in addition to traditional telemonitoring. The modified Genesis Touch monitor expands the user population to include patients and caregivers willing and capable of managing its use. The modified Genesis Touch System is a touch screen tablet with a consumer-based Android platform like the predicate Genesis Touch System. This type of user interface is easily usable by a wider age and acuity range. The user population of the predicate monitors, Genesis Touch System and Genesis DM Monitor are designated for use with adult and pediatric patients over twelve years of age. The expanded user population of the modified Genesis Touch System is presented in order to compliment the user population of interfaced peripheral medical devices which do not limit the user population to being over twelve years of age. This modification does not change the intended use of the modified Genesis Touch System as a communication hub that collects; displays and transmits vital signs data from noninvasive medical device peripherals via a communication module to a central viewing station for retrospective review by a healthcare professional. This modification does not affect the safety and effectiveness of the Genesis Touch System when used as labeled.

The Honeywell HomMed Genesis Touch Retrospective Physiological Monitoring System is designed to retrospectively monitor vital signs include noninvasive blood pressure, pulse oximetry, pulse rate, weight and manually entered temperature. The Genesis Touch Retrospective Physiological Monitoring System collects, displays and transmits vital signs measurements captured from commercially available FDA cleared wireless medical devices designed for home use. Collected measurement data from the Genesis Touch System can be transmitted.via a communication module to a central viewing station where the data can be viewed and analyzed by a healthcare professional. The Genesis Touch Retrospective Physiological Monitoring System is intended for home use by adult and pediatric patients over twelve years of age or in a healthcare related environment by healthcare providers. The Genesis Touch Retrospective Physiological Monitoring System is not intended for emergency use or real-time monitoring and does not have auditory or visual alarms for out-of-limit parameters.

The Honeywell HomMed Genesis Touch™ Retrospective Physiological Monitoring System uses text and voice prompts to help the user acquire vital signs information. Once all data is collected, it is forwarded at the user's discretion, as a data packet to a central viewing station for retrospective review by a healthcare provider. The Genesis Touch Retrospective Physiological Monitoring System is intended for use with adult and pediatric patients over twelve years of age. The Genesis Touch Retrospective Physiological Monitoring System is not intended for emergency use or real-time monitoring.

The Honeywell HomMed Genesis DM Monitor is designed to retrospectively monitor vital signs. Vital signs include noninvasive blood pressure, pulse rate, and weight. Data from optional commercial stand-alone products extend Genesis DM Monitor's measurement capabilities. Data from the Genesis DM Monitor can be transmitted via a communication module to a central viewing station for display. The Genesis DM Monitor is not intended for emergency use or realtime monitoring.

The Honeywell HomMed Genesis DM Monitor is designed to retrospectively monitor vital signs. Vital signs include noninvasive blood pressure, pulse rate, and weight. Data from optional commercial stand-alone products extend Genesis DM Monitor's measurement capabilities. Data from the Genesis DM Monitor can be transmitted via a communication module to a central viewing station for display. The Genesis DM Monitor is not intended for emergency use or realtime monitoring.

Central Station's intended use is to retrospectively receive; display and store monitored vital signs parameters and related data. Central Station displays the data and system alerts for review and evaluation by a healthcare professional. Central Station is not intended for emergency use or real-time monitoring.

Central Station is a software system that operates on a commercially available PC system with the minimum performance specifications consistent with typical PC hardware and equipment specifications. Central Station accepts data from Honeywell HomMed Patient Monitors (e.g. Sentry and Genesis) as well as the Honeywell HomMed MedPartner.

The Honeywell HomMed Genesis OTC Monitor is designed to retrospectively monitor vital signs. Vital signs include noninvasive blood pressure, pulse rate, and weight. Data from optional commercial stand-alone products extend Genesis OTC Monitor's measurement capabilities. Data from the Genesis OTC Monitor can be transmitted via a communication module to a central viewing station for display. The Genesis OTC Monitor is not intended for emergency use or real-time monitoring.

The Honeywell HomMed Genesis OTC Monitor System is a vital signs monitoring system. The system measures noninvasive blood pressure, pulse rate, and weight. The Genesis OTC Monitor has four serial ports available for external options. The Genesis OTC Monitor acquires vital signs data and displays it. The data can also be transmitted via the communication system to a central viewing station.

The Honeywell HomMed Sentry OTC Monitor is designed to retrospectively monitor vital signs. Vital signs include noninvasive blood pressure, pulse rate, oral temperature and weight. Data from optional commercial stand-alone products extend the Sentry OTC Monitor's measurement capabilities. Data from the Sentry OTC Monitor can be transmitted via a communication module to a central viewing station for display. The Sentry OTC Monitor is not intended for emergency use or real-time monitoring.

The Honeywell HomMed Sentry OTC Monitor is a vital signs monitoring system. The system measures noninvasive blood pressure, pulse rate, oral temperature and weight. The Sentry OTC Monitor has six serial ports available for external options. The Sentry OTC Monitor acquires the vital signs data and displays it. The data can be transmitted via the communication module to a central viewing station.

Central Station's intended use is to retrospectively receive, display and store monitored vital signs parameters and related data. The Central Station displays the data and system alerts for review and interpretation by a healthcare professional. Central Station is not intended for emergency use or real-time monitoring.

Central Station is a software system that operates on a commercially available PC system with the minimum performance specifications consistent with typical PC hardware and equipment specifications. Central Station accepts data from Honeywell HomMed Patient Monitors (Sentry and Genesis) as well as the Honeywell HomMed MedPartner.