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The Capsule Vitals Plus Patient Monitoring System is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), end-tidal and fractional concentration of inspired CO2, respiration, and temperature, on adult, pediatric, and neonatal patients in health care facilities when used by clinical physicians or appropriate medical staff under the direction of physicians.

The Capsule Vitals Plus Patient Monitoring System which is the subject of this submission is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), end-tidal and fractional concentration of inspired CO2, respiration, and temperature, on adult, pediatric, and neonatal patients in health care facilities when used by. It operates with the Capsule Medical Device Information Platform (CMDIP) a Medical Device Data System to present patient information to the clinical user for active monitoring purposes at the point of care. The proposed Capsule Vitals Plus Patient Monitoring System consists of the following components: - -Capsule Neuron Mobile Platforms - Capsule Vitals Plus Application | - Capsule Vitals Plus NIBP Monitoring Modules - - Masimo NomoLine Infrared Sidestream Gas Analyzer ISA C02 — - Capsule Capnography Interface Module - - Nellcor SpO2 Oximetry Module - - Masimo uSpO2 Pulse Oximetry Cable - -Exergen TAT-5000S Temperature Scanner - -Capsule Early Warning Scoring System

The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), end-tidal and fractional concentration of inspired CO2, respiration, and temperature, on adult, pediatric, and neonatal patients in health care facilities when used by clinical physicians or appropriate medical staff under the direction of physicians.

The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), end-tidal and fractional concentration of inspired CO2, respiration, and temperature, on adult, pediatric, and neonatal patients in health care facilities when used by clinical physicians or appropriate medical staff under the direction of physicians. The SmartLinx Vitals Plus Patient Monitoring System operates with the SmartLinx Medical Device Information Platform (MDIP) a Medical Device Data System to present patient information to the clinical user for active monitoring purposes at the point of care. The proposed SmartLinx Vitals Plus Patient Monitoring System consists of the following components: - SmartLinx Neuron Mobile Platform - SmartLinx Vitals Plus Application - SmartLinx Vitals Plus NIBP Monitoring Module - Masimo NomoLine Infrared Sidestream Gas Analyzer ISA C02 - Nellcor SpO2 Oximetry Module - Masimo uSpO2 Pulse Oximetry Cable - Exergen TAT-5000S Temperature Scanner - SmartLinx Early Warning Scoring System

The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), and temperature, on adult, pediatric, and neonatal patients in hospital environments when used by clinical physicians or appropriate medical staff under the direction of physicians.

The predicate device, SmartLinx Vitals Plus Patient Monitoring System, was cleared in K180734. The SmartLinx Vitals Plus Patient Monitoring System operates on top of the SmartLinx Medical Device Information System (MDIS) to present patient information to the clinical user for active monitoring purposes at the point of care. The proposed SmartLinx SmartLinx Vitals Plus Patient Monitoring System is similar to the predicate SmartLinx Vitals Plus Patient Monitoring System, cleared in K180734. The change being proposed is to integrate the SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus Alarm Hub and Nellcor SpO2 Pulse Oximetry Module into one module or backpack configuration; and the alternative Masimo SpO2 pulse oximetry cable will continue to be connected to the same place as with the predicate. There is no change to the performance or functionality of the device. There is no change to the indications for use or intended use.

The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), and temperature, on adult, pediatric, and neonatal patients in hospital environments when used by clinical physicians or appropriate medical staff under the direction of physicians.

The SmartLinx Vitals Plus Patient Monitoring System operates on top of the SmartLinx Medical Device Information System (MDIS) to present patient information to the clinical user for active monitoring purposes at the point of care. It consists of the SmartLinx Vitals Plus Application (a mobile medical application operating on the SmartLinx Neuron 2 Mobile Platform), SmartLinx Vitals Plus NIBP Module, Masimo uSpO2 Pulse Oximetry Cable, Exergen TAT-5000S Thermometer, Covidien FILAC 3000 Thermometer, SmartLinx Vitals Plus Alarm Hub, SmartLinx Neuron 2 Mobile Platform, and optionally the SmartLinx Early Warning Scoring System (EWSS). The system collects vital signs data from sensors connected to the SmartLinx Neuron 2 Mobile Platform, which serves as the user interface and supports connectivity with the electronic medical record (eMR). The proposed device is identical to the predicate device (K171751) with the addition of the option for Nellcor SpO2 Pulse Oximetry solution and software upgrades.

The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), and temperature, on adult, pediatric, and neonatal patients in hospital environments when used by clinical physicians or appropriate medical staff under the direction of physicians.

The SmartLinx Vitals Plus Patient Monitoring System operates on top of the SmartLinx Medical Device Information System (MDIS) to present patient information to the clinical user for active monitoring purposes at the point of care. SmartLinx Vitals Plus consists of the following components: SmartLinx Vitals Plus Application, SmartLinx Vitals Plus NIBP Module, Masimo uSpO2 Pulse Oximetry Cable, Exergen TAT-5000S Thermometer, Covidien FILAC 3000 Thermometer, SmartLinx Vitals Plus Alarm Hub, SmartLinx Neuron 2 Mobile Platform, and SmartLinx Early Warning Scoring System.

The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), and temperature, on adult, pediatric, and neonatal patients in healthcare facilities when used by clinical physicians or appropriate medical staff under the direction of physicians.

The SmartLinx Vitals Plus Patient Monitoring System consists of the SmartLinx Vitals Plus mobile medical application and externally integrated vital signs modules operating on the SmartLinx Neuron 2 mobile platform. The application controls the modules at the point of care through interfaces on the SmartLinx Neuron 2 mobile platform and presents this to the monitoring purposes. The supported physiological parameters are: non-invasive blood pressure (systolic, diastolic, mean arterial pressure (MAP)), pulse rate, functional arterial oxygen saturation (SpO2), and temperature. The SmartLinx Vitals Plus Patient Monitoring System is composed of multiple products: - The SmartLinx Vitals Plus mobile medical application - The SmartLinx Vitals Plus NIBP Module with SunTech Medical cuffs and hoses - The Masimo SET uSpO2 Pulse Oximetry Cable - The Exergen TAT-5000S infrared thermometer - The SmartLinx Neuron 2 Mobile Platform - The SmartLinx Vitals Plus Roll Stand

The DataCaptor™ System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. DataCaptor™ is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.

Based on an open-architecture design, DataCaptor is a data acquisition and distribution software, using ActiveX and the Distributed Component Object Model. This tool retrieves data from serial, network or analog devices and, via an ActiveX control, makes this data available over network or any other type of communication for use in software applications. We do not supply any hardware - our customers can buy cable and connect the devices directly to the COM port (we provide a wiring diagram that shows them pin configurations) or they can use a multiport box or card, an RS-232 to Ethernet converter is used if several devices need to be connected to the network and there are not necessarily computers next to each one. We don't recommend hardware suppliers. The change enables interface to additional models of connected medical devices. Also the DataCaptor Solution now includes the DMM Server module and the DataPortal module. The DMM Server module allows one to process the data originating from the devices and decoded by DataCaptor, i-e, it allows users to create averages, to suppress some data, to streamline the frequency of data that come out of DataCaptor. The DataPortal module converts a dataflow from a Microsoft COM (Component Object Model) container into a TCP/IP Sockets container

The DataCaptor™ System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. DataCaptor™ is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.

Based on an open-architecture design, DataCaptor is a data acquisition and distribution software, using ActiveX and the Distributed Component Object Model. This tool retrieves data from serial, network or analog devices and, via an ActiveX control, makes this data available over network or any other type of communication for use in software applications. We do not supply any hardware - our customers can buy cable and connect the devices directly to the COM port (we provide a wiring diagram that shows them pin configurations) or they can use a multiport box or card, an RS-232 to Ethernet converter is used if several devices need to be connected to the network and there are not necessarily computers next to each one. We don't recommend hardware suppliers.

The DataCaptor™ System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. DataCaptor™ is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.

Based on an open-architecture design, DataCaptor is a data acquisition and distribution software, using ActiveX and the Distributed Component Object Model. This tool retrieves data from serial, network or analog devices and, via an ActiveX control, makes this data available over network or any other type of communication for use in software applications. We do not supply any hardware - our customers can buy cable and connect the devices directly to the COM port (we provide a wiring diagram that shows them pin configurations) or they can use a multiport box or card, an RS-232 to Ethernet converter is used if several devices need to be connected to the network and there are not necessarily computers next to each one. We don't recommend hardware suppliers.