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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 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