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The Cogent HMS is intended for patients for whom the monitoring of CCO and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician. The Cogent HMS is intended for use with ICU Medical pulmonary artery catheters and central venous oximetry catheters and with ICU Medical Cogent sensors. The Cogent HMS is intended to measure and calculate venous oxygen saturation in patients. PulseCO functionality is limited to adult patients.

The Cogent HMS is designed to compute and display cardiac and oximetry parameters relevant to patient care in the hospital acute care areas including Intensive Care Units and the Operating Room. Monitoring parameters include cardiac output and blood oxygen saturation levels, as well as other derived hemodynamic parameters. Measurements are obtained through the compatible ICU Medical pulmonary artery and central venous oximetry catheters, and ICU Medical CardioFlo™ sensors. Input data for derived parameters may be keyed in by a clinician or may be obtained from a bedside monitor. The Cogent HMS provides the following functions: - monitors patient cardiac output continuously (CCO) using continuous thermodilution -(TdCO), and intermittently, using bolus thermodilution (Bolus CO); - monitors continuous cardiac output (CCO) using pulse power analysis on an arterial pressure waveform; - monitors venous oxygen saturation (SvO2) by measuring the reflectance spectrum of the blood; and - provides a general-purpose interface to the analog input/output channels of other monitoring devices. The Cogent HMS consists of: - a base unit (patient interface module or PIM); - a dedicated touch-screen display unit (user interface module or UIM) which allows for patient monitoring remotely (up to 50 feet); and - associated cables The PIM and UIM modules communicate with each other in docked, tethered (wired) or wireless mode.

Hypotension Decision Assist is indicated to acquire, process and display arterial pressure and other key cardiovascular characteristics of adult patients who are at least eighteen years of age that are undergoing surgery where their arterial pressure is being continuously monitored by a vital-signs monitor. It is indicated for use to assist anesthesia healthcare professionals manage the blood pressure, hemodynamic stability and the cardiovascular system during such surgery.

Hypotension Decision Assist (HDA) is a clinical decision support Software as a Medical Device (SaMD) that is installed upon a medically-rated touch-screen computer. HDA connects to a multi-parameter patient monitor supplied by other manufacturers, from which it acquires vital signs data continuously including the arterial blood pressure waveform and cardiovascular-related numeric parameters. HDA continually processes this data to display, in graphical charts and numeric format, vital signs data and derived variables including mean arterial pressure (MAP), heart rate, systolic and diastolic blood pressure, cardiac output and systemic vascular resistance. HDA compares MAP to user set targets to indicate when MAP is above or below the target range. It allows the user to mark the administration of vasopressors and volume challenges to the MAP trend.

The PulsioFlex Monitoring System is a diagnostic aid for the measurement and monitoring of blood pressure, cardiopulmonary, circulatory and organ function variables. The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient's biometric data are entered, the PulsioFlex Monitor presents the derived parameters indexed. - With the PiCCO Module cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. Both are used for the determination of other derived parameters. - With the CeVOX oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System measures continuous venous oxygen saturation to assess oxygen delivery and consumption. - With the ProAQT Sensor, the PulsioFlex Monitoring System uses arterial pulse contour analysis for continuous hemodynamic monitoring. The use of the PulsioFlex Monitoring System is indicated in patients where cardiovascular and organ monitoring is useful. This includes patients in surgical, medical, and other hospital units.

The PulsioFlex Monitoring System is a patient monitoring system that consists of the following components: a) PulsioFlex Monitor b) PiCCO Module c) CeVOX Optical Module d) ProAQT Sensor

The EV 1000 Clinical Platform is indicated for use primarily for critical care patients in which the balance between cardiac function, fluid status and vascular resistance needs continuous or intermittent assessment. The EV1000 Clinical Platform may be used for the monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol. Analysis of the thermodilution curve in terms of mean transit time and the shape is used to determine intravascular and extravascular fluid volumes. When connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics. The EV1000 Clinical Platform may be used in all settings in which critical care is provided. The Edwards Lifesciences Acumen Hypotension Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen is intended for use in surgical or nonsurgical patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter.

The EV1000 Clinical Platform measures patient physiologic parameters in a minimally invasive manner when it is used as a system with various Edwards' components, including the Edwards pressure transducers, the FloTrac sensor, the components of the VolumeView System, oximetry catheters/sensors, and the corresponding accessories applied to the patient. The EV1000 Clinical Platform includes an Acumen Hypotension Prediction Index (HPI) feature, which is an index related to the likelihood of a patient experiencing a hypotensive event (defined as mean arterial pressure (MAP) < 65 mmHg for one minute in duration) within 15 minutes, where zero (0) indicates low likelihood and one hundred (100) indicates high likelihood. The Acumen Hypotension Prediction Index, HPI, should not be used exclusively to treat patients. A review of the patient's hemodynamics is recommended prior to initiating treatment. The EV1000 Clinical Platform consists of the EV1000 Monitor (Monitor), the EV1000 Databox (Databox), and an Ethernet cable to connect the Databox to the Monitor. It may be attached to the patient bedside, an IV pole or roll stand. A design hardware change for the AC inlet related to a corrective action was made. The additional hardware for the EV1000A power adaptor prevent liquid ingress or other conductive contaminates from entering the AC inlet.

Hypotension Decision Assist is indicated to acquire, process and display arterial pressure and other key cardiovascular characteristics of adult patients who are at least eighteen years of age that are undergoing surgery where their arterial pressure is being continuously monitored by a vital-signs monitor. It is indicated for use to assist anesthesia healtheare professionals manage the blood pressure, hemodynamic stability and the cardiovascular system during such surgery.

Hypotension Decision Assist (HDA) is a clinical decision support Software as a Medical Device (SaMD) that is installed upon a medically-rated touch-screen computer. HDA connects to a multi-parameter patient monitor supplied by other manufacturers, from which it acquires vital signs data continuously including the arterial blood pressure waveform and cardiovascular-related numeric parameters. HDA continually processes this data to display, in graphical charts and numeric format, vital signs data and derived variables including mean arterial pressure (MAP), heart rate, systolic and diastolic blood pressure, cardiac output and systemic vascular resistance. HDA compares MAP to user set targets to indicate when MAP is above or below the target range. It allows the user to mark the administration of vasopressors and volume challenges to the MAP trend.

The Argos Cardiac Output monitoring device is intended for use on patients above the age of 18. It is intended to be used as a hemodynamic monitor for monitoring cardiac output and its derived parameters on patients in the intensive care unit or the operating room.

The Argos Monitor is a portable hemodynamic monitor that calculates Cardiac Output and other derived parameters, including cardiac index (CI), stroke volume (SV), stroke volume index (SVI), systemic vascular resistance (SVR), systemic vascular resistance index (SVRI), mean arterial pressure (MAP), heart rate (HR), and pulse pressure variation (PPV) based on a proprietary algorithm that analyzes the blood pressure waveform and user-entered patient demographic information (age, height weight and gender). The blood pressure waveform is input into the monitor via a connection with either a radial arterial catheter or the analog blood pressure signal output of a vital signs monitor. The scientific method that underlies the algorithm is based on a novel signal processing technique to determine the parameters of the well-established Windkessel model of the circulation in order to calculate cardiac output. The Argos Monitor comes with a touchscreen monitor and computer system enclosed in a rigid plastic housing and a power cable. Cables to connect the monitor to a radial blood pressure transducer or to the analog blood pressure signal output of a vital signs monitor are also provided according to the setup and needs of the individual institution. The Monitor may be attached to a pole or a table stand via a standard screw interface pattern.

The PulsioFlex Monitoring System is a diagnostic aid for the measurement and monitoring of blood pressure, cardiopulmonary, circulatory and organ function variables. The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient's data are entered, the PulsioFlex monitor presents the derived parameters indexed. With the PiCCO Module cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. Both are used for the determination of other derived parameters. With the CeVOX oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System measures continuous venous oxygen saturation to assess oxygen delivery and consumption. The use of the PulsioFlex Monitoring System is indicated in patients where cardiovascular and organ monitoring is useful. This includes patients in surgical, medical, and other hospital units.

The PulsioFlex Monitoring System is a patient monitoring system that consists of the following components: a) PulsioFlex Monitor b) CeVOX Optical Module c) PICCO Module The PulsioFlex Monitor receives incoming signals from the patient through the connections with the modules and the accessories applied to the patient. The measurement hardware in the PulsioFlex Monitoring System provides the PulsioFlex host application (software) all data from the modules via USB protocol. The algorithms embedded in the monitor host application process the signals and provide parameter calculations. Based on the patient's biometric data, the PulsioFlex Monitor presents the derived parameters indexed.

The LiDCOunity Monitor is intended for use under the direct supervision of a licensed healthcare or by personnel trained in its proper use for: 1. The measurement of blood pressure, cardiac output and associated hemodynamic parameters in adult patients. 2. When connected to the BIS Module: monitoring the state of the brain by data acquisition of EEG signals and may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation. 3. When connected to the LiDCO CNAP Module it may be used for the continuous, non-invasive monitoring of arterial blood pressure in adults and pediatric (>4yrs) patients by medical professionals. The LiDCO CNAP Module is intended for use with the LiDCOunity Monitor 4. The measurement of cardiac output via Lithium Indicator Dilution in adult patients (>40Kg/88lbs) with pre-inserted arterial and venous catheters, and for monitoring continuous blood pressure and cardiac output in patients with preexisting peripheral arterial line access 5. In addition to arterial blood pressure parameters and cardiac output, the LiDCOunty Monitor of derived parameters: Body Surface Area, Pulse Pressure Variation, Stroke Volume Variation, Cardiac Index, Stroke Volume, Stroke Volume Index, Systemic Vascular Resistance, Systemic Vascular Resistance Index, Oxygen Delivery/ Index Location of Use: Suitable patients will be receiving treatment in the following areas: Medical and Surgical Intensive Care Units Operative Suites Step Down / High Dependency Units Trauma/Accident & Emergency Departments Coronary Intensive Care Units Cardiac Catheter Laboratories

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The LiDCOunity Monitor is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use for: 1. The measurement of blood pressure, cardiac output and associated hemodynamic parameters in adult patients. 2. When connected to the BIS Module: monitoring the state of the brain by data acquisition of EEG signals and may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation. 3. When connected to the LiDCO CNAP Module it may be used for the continuous, non-invasive monitoring of arterial blood pressure in adults and pediatric (>4yrs) patients by medical professionals. The LiDCO CNAP Module is intended for use with the LiDCOunity Monitor 4. The measurement of cardiac output via Lithium Indicator Dilution in adult patients (>40Kg/88lbs) with pre-inserted arterial and venous catheters, and for monitoring continuous blood pressure and cardiac output in patients with pre-existing peripheral arterial line access 5. In addition to arterial blood pressure parameters and cardiac output, the LiDCOunity Monitor calculates a number of derived parameters: Body Surface Area, Pulse Pressure Variation, Stroke Volume Variation, Cardiac Index, Stroke Volume, Stroke Volume Index, Systemic Vascular Resistance, Systemic Vascular Resistance Index, Oxygen Delivery/Index

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The intended use of the ELSA system is to provide clinically relevant data to healthcare providers treating neonatal, pediatric, adult patients with arterial and venous lines for routine monitoring of diagnostic parameters: Delivered Flow; Recirculation: Oxygenator Blood Volume and other associated hemodynamic parameters.

In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, Transonic Systems Inc. intends to introduce into interstate commerce the Transonic ELSA system, which is an apparatus based on transit time ultrasound indicator dilution techniques that provides clinically relevant data to healthcare providers treating patients undergoing Extracorporeal Life Support Procedures. The clinically relevant data (such as delivered flow, recirculation, oxygenator blood volume and other related hemodynamic parameters), shall indicate the efficacy of such procedures and quantify the patient's hemodynamic status. These patients could be in the intensive care units (ICU), operating room (OR) or other such environments.