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The Envoy is intended for use as a multiparameter monitoring system. The Envoy can monitor ECG/heart rate, two invasive blood pressure channels, two temperature channels, pulse oximetry, respiration, non-invasive blood pressure, etCO2 and Spirometry. This effectively allows the Envoy to monitor a wide-range of adult, pediatric and neonatal patient conditions, in many different areas of the hospital. The Envoy also includes a spirometer intended for continuous monitoring of adult and pediatric patients with tidal volumes greater than 100mL. Functions include display of multiparameter waveforms, vital signs, and status messages. The Spirometry module is used to provide an objective measurement of lung function. The Spirometry module is intended for use in the hospital clinical environment only (e.g. in the RICU). The module is used for the continuous monitoring of mechanically ventilated adult and pediatric patients, or adult and pediatric patients able to breathe spontaneously. In both cases, the patient is connected to the module via an endotracheal tube or mask. The module is to be used only for patients with tidal volumes greater than 100 ml.

The Envoy is a multiparameter physiological patient monitor consisting of a main processing unit, a mountable color monitor, and a module rack housing the various Mennen Medical plug-in vital signs modules to monitor the patient's vital signs. Up to six internal modules can be plugged into a module rack. The Envoy can accommodate two module racks. Data presented from the modules by the Envoy are presented on the monitor as waveform and numeric displays. The Envoy vital signs modules acquire vital signs data from the patient, and display their indications on the Envoy display unit. Vital signs and waveform information are displayed simultaneously on the Envoy Display Unit. Up to 8 traces can be displayed at any one time. The Envoy is a reusable, software driven, patient monitor, intended for use as part of a physiological monitoring system in a hospital environment. As such, it is not a life supporting, nor is it implantable and therefore sterility is not a consideration. The Envoy is not a kit and does not contain any drug or biological products. The Spirometry module of the Envoy patient monitor is not sold as a stand-alone spirometry device, but as part of a multiparameter physiological patient monitoring system (ENVOY).

The ENVOY Monitor is a physiological patient monitor intended to be used for monitoring vital signs of critically ill adult and pediatric patients in the hospital environment, such as: ECG/Heart Rate, Invasive Blood Pressure, Respiration, Temperature, Noninvasive Blood Pressure, Pulse Oximetry and EtCO2. The ENVOY may be used to monitor a wide range of patient conditions in many different clinical specialties within the hospital. The device is intended for use by qualified health care providers, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

ENVOY EtCO2 is a hospital based module, for monitoring EtCO2 physiological patient vital signs. ENVOY vital signs EtCO2 module acquires vital signs data from the patient, and displays the patients waveform and alarms indication on the ENVOY display unit. This information is displayed simultaneously on the ENVOY Display Unit. All processing and alarm determination for EtCO2 is made using Pryon technology based on currently marketed Pryon monitoring devices. Information from each vital sign is presented in a separate portion of the display. Each vital sign is labeled for identification and numeric value. Displayed Vital sign information can include: Primary Vital Sign Name, Waveform, Vital Sign Numeric Value, Alarm Status Message. Selection of the EtCO2 functions is accomplished by interaction with front panel controls on the main processor unit. A quick-knob control allows direct interaction with displayed menus for direct parameter selection and setup. Where manual entry of alphanumeric information is required, a menu keyboard menu is display.

The HORIZON 9000 WS (Cathlab) is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressure, pulse oximetry, respiration, cardiac output and body temperature. Heart rate, multi-lead ECG and BP waveforms from different heart sites are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform and numerical, can be stored, recorded, analyzed and presented in a variety of report formats.

The HORIZON 9000 WS (Cathlab) is a state-of-the-art computerized laboratory, whose prime function is the acquisition and display of vital-sign data and waveforms in real time during the catheterization process, creating a fully documented case history. The Cathlab is capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressure, pulse oximetry, respiration, cardiac output and body temperature. Heart rate, multi-lead ECG and BP waveforms from different heart sites are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform and numerical, can be stored, recorded, analyzed and presented in a variety of report formats. The system has a UNIX Sun Solaris 2 (Ultra 5 computer) that utilizes powerful, real-time software to control the system operation and to process the vital patient sign data measurements acquired from the Physiological Front End or entered manually at the keyboard. The Thermal Array Chart Recorder provides a continuous recording of all monitored vital signs, patient ID, time and date during the procedures. A Laser Printer is provided in addition to the Chart Recorder in the central console. This provides print-outs of textual and graphical summaries of all patient data and catheterization procedures.

ENSEMBLE includes the essential features of a central station monitor for up to 12 patients. It can display vital signs information collected from bedside patient monitoring devices such as: ECG/Heart Rate, Arrhythmia (basic and extended alarms), ST Segment, Respiration, Temperature, Invasive Blood Pressure, Noninvasive Blood Pressure, Pulse Oximetry, and End Tidal carbon-dioxide. The ENSEMBLE may be used in system application in many different clinical specialties within the hospital.

The Ensemble Central Station is able to display the signals that are transmitted to it by the patient monitor to which it is connected via the communication network.

The ENVOY Monitor is a physiological patient monitor intended to be used for monitoring vital signs of critically ill adult and pediatric patients in the hospital environment, such as: ECG/Heart Rate, Invasive Blood Pressure, Respiration, Temperature, Noninvasive Blood Pressure, and Pulse Oximetry. The ENVOY may be used to monitor a wide range of patient conditions in many different clinical specialties within the hospital. The device is intended for use by qualified health care providers, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

ENVOY is hospital based, multiparameter patient monitor for monitoring physiological patient vital signs. The ENVOY patient monitor system consists of the following components: Main Processing Unit, Display Unit, Module Rack, Vital Signs Plug-in Modules. ENVOY vital signs modules acquire vital signs data from the patient, and display their waveforms and alarms indications on the ENVOY display unit. Vital signs and waveform information are displayed simultaneously on the ENVOY Display Unit. Up to 8 traces can be displayed at any one time. The vital signs modules interface with readily available physiologic transducers through electrically isolated patient input connections. After amplification, the signals are digitized, analyzed and displayed. All processing and alarm determination for ECG, Respiration and Invasive Blood Pressure is made using proprietary algorithms and software based on previously marketed Mennen Medical monitoring devices tested against well known and accepted data bases that present representative examples of waveform artifact to be encountered in real case conditions. SpO2 and Non-Invasive Blood Pressure Modules use sofware/hardware from vendors whose products already appearing on the USA market. Information from each vital sign is presented in a separate portion of the display. Each vital sign is labeled for identification and numeric value. Displayed Vital sign information can include: Primary Vital Sign Name, Waveform, Vital Sign Numeric Value, Alarm Status Message. Operation of the ENVOY is accomplished by interaction with front panel controls on the main processor unit. A quick-knob control allows direct interaction with displayed menus for direct parameter selection and setup. Where manual entry of alphanumeric information is required, a menu keyboard menu is display. ENVOY is a reusable, software driven, patient monitor, intended for use as part of a physiological monitoring system in a hospital environment. As such it is not a life supporting, or life sustaining device; nor is it implantable and therefore sterility is not a consideration.

ENSEMBLE includes the essential features of a central station monitor for up to 12 patients. It can display vital signs information collected from bedside patient monitoring devices such as: ECG/Heart Rate, Arrhythmia (basic and extended alarms), ST Segment, Respiration, Temperature, Invasive Blood Pressure, Noninvasive Blood Pressure, Pulse Oximetry, and End Tidal carbon-dioxide. The ENSEMBLE may be used in system application in many different clinical specialties within the hospital.

ENSEMBLE is hospital based, multi-patient, multi-parameter display terminal. As such, it is a component in a physiological patient vital signs monitoring system. A system consists of any of the several possible combinations of the following components: Bedside Devices HORIZON XL patient monitor, and/or 219 TELEMETRY RECEIVER/TRANSMITTER with NS-7, (K911616, and K895395, respectively) Ethernet™ Communication Network Documentation Peripherals (Chart Recorders and Laser Printers), and ENSEMBLE Central Station Monitor. ENSEMBLE acquires patient vital signs, waveforms and alarm indications from Mennen Medical HORIZON XL and 219 TELEMETRY systems. All processing and alarm determination is made in these "bedside devices", using proprietary algorithms and software contained therein. Processed information is communicated from the bedside devices to one or more ENSEMBLE Central Station Monitors by the Mennen Medical ENSEMBLE system Ethernet™ network. If documentation is requested, information is transmitted to the appropriate Documentation Peripheral, using the same network. Although ENSEMBLE does not make alarm determinations, it does provide users with a remote interaction capability, allowing users to make changes to both parameter and alarm settings in the remote bedside devices. Similarly, ENSEMBLE users have a remote interactive capability to initiate recordings or printing of patient information and waveforms. Vital signs and waveform information from up to 12 patients are be displayed simultaneously on an ENSEMBLE Central Station Monitor. Information from each individual patient is presented in a separate portion of the display. Each patient display area includes: Patient Name, Assigned Location (room), Primary Vital Sign Name, Value & Alarm Limits (nominally Heart Rate), Primary Waveform (nominally ECG), Secondary Vital Sign Numeric Data, Alarm Status Messages, and a dedicated "soft key" for recording waveforms. Software configurations allow more than one waveform or parameter to be displayed for each patient. Primary operation of the ENSEMBLE is accomplished by a desktop mouse. A standard computer keyboard is used for manual entry of alphanumeric information. An optional touchscreen is available for users who prefer to use a touchscreen. Alternative "desktop devices", such as trackball and light pen, are also available as options. For large installations, with several ENSEMBLEs intended for a single user, the system may be configured to enable one keyboard and one mouse to control up to eight individual ENSEMBLE computers. ENSEMBLE is a reusable, software driven, central station display terminal, intended for use as part of a physiological monitoring system in a hospital environment. As such it is not a life supporting, or life sustaining device; nor is it implantable and therefore sterility is not a consideration. ENSEMBLE complies with UL 544, ANSI Safe Current Limits for Electromedical Apparatus, and FDA MDS-201-0004 voluntary standards. ENSEMBLE is not a kit, does not contain any drug or biological products and is for prescription use,