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The Cheetah Reliant with NIBP and SpO2 functionalities is a portable, hemodynamic monitoring and non-invasive Cardiac Output monitoring device that monitors and displays a patient' Cardiac Output (CO) in Ltr/Min with a Non Invasive Blood Pressure (NIBP) function that non-invasively measures and displays blood pressure (diastolic, systolic and mean arterial pressure) and heart rate and with a SpO2 function that non-invasively measures and displays blood oxygen saturation (SpO2). The device displays associated heamodynamic parameters based on calculations with measurements incorporated into the Cheetah Reliant. These parameters are: - Cardiac Index (CI), - Stroke Volume (SV), - Stroke Volume Index (SVI), - Stroke Volume Variation (SVV), - Heart Rate (HR), - Ventricular Ejection Time (VET), - Total Peripheral Resistance (TPR), - Total Peripheral Resistance Index (TPRI), - Cardiac Power (CP), - Cardiac Power Index (CPI), - Oxygen Delivery Index (DO2I), - Electrical impedance of the chest cavity (Z0), - Thoracic Fluid Content (TFC), - Thoracic Fluid Content change from preset time period (TFCd) and - Thoracic Fluid Content from baseline (TFCd0). - Orthostatic Bioreactance (Postural changes in SV, CO and other hemodynamic parameters which are derived by Bioreactance) The Cheetah Reliant with NIBP and SpO2 functionalities is intended for use within hospitals and other healthcare facilities (e.g., outpatient clinics) that provide patient care.

The Cheetah Reliant with oxygen saturation (SpO2) function is a modification of the Cheetah Reliant device cleared under K083093. The significant modification is the addition of a non invasive Oxygen Saturation (SpO2) module to the system which involved updating the user interface to allow operating the SpO2 module and for displaying the results and saving them within the device's database. The SpO2 Module is the NELLCOR OxiMax NELL-1 Pulse Oximetry Module, manufactured by NELLCOR Pleasanton, CA ,USA, a division of Covidien. It is the same module that is in the NELLCOR OxiMax N-600x Pulse Oximeter (K060576). The NELL-1 pulse oximeter board that is integrated into the Cheetah Reliant. uses calibration data contained in the OxiMax pulse oximetry sensor when calculating the patient's SpO2. The NELL-1 Module connects to a OxiMax pulse oximetry sensor (DS-100A Durasensor®, the same sensor cleared with the OxiMax N-600x, K060576), through a Pulse Oximetry Cable (NELLCOR, DOC-10) that was also cleared with the OxiMax N-600x Pulse Oximeter (K060576) and provides oscillometric oxygen saturation to the Host system. The Module is controlled via software commands issued from the Host system through an asynchronous serial data port. All Module operations are initiated by the Reliant as the Host system. The Module is designed to take blood oxygen saturation measurements on demand.

The Cheetah Reliant with NIBP functionality is a portable, non-invasive Cardiac Output monitoring device that monitors and displays a patient' Cardiac Output (CO) in Ltr/Min with a non-invasive blood pressure function that non-invasively measures and displays blood pressure (diastolic, systolic, and mean). In addition, the device measures and displays associated hemodynamic parameters based on calculations of measurements already incorporated into the Cheetah Reliant. These parameters are: Cardiac Index (CI), Ventricular Ejection Time (VET), Total Peripheral Resistance Index (TPRI), Stroke Volume Index (SVI), Stroke Volume Variation (SVV), Cardiac Power (CP), Cardiac Power Index (CPI) and Thoracic Fluid Content (TFC). The Cheetah Reliant with NIBP functionality is intended for use within hospitals and other healthcare facilities (e.g., outpatient clinics) that provide patient care. The alternative NICOM Sensors are disposable electrodes used in conjunction with the Cheetah Medical NICOM signal processing product line.

The Cheetah Reliant non-invasive CO monitor (NICOM) is a portable, non-invasive, Cardiac Output detector system. The NICOM system measures the Cardiac Output by employing the electrical bio-impedance measurement technique. Electrical bio-impedance is the characteristic impedance of a volume of tissue and fluid. In the case of Cardiac Output measurements, the relevant tissue includes the heart and the immediate surrounding volume of the thorax. The relevant fluid is blood. Cheetah Medical's alternative NICOM Sensor is a double electrode sticker. Within each sticker, one electrode is used to inject the a high frequency sine wave into the body, while the resulting voltage is measured at the adjacent electrode. An array of such electrodes is placed at specific areas of the thorax, the impedance to the current flow calculated, and finally the electrical bio-reactance waveform constructed.

The Cheetah Reliant with NIBP functionality is a portable, non-invasive Cardiac Output monitoring device that monitors and displays a patient' Cardiac Output (CO) in Ltr/Min with a non-invasive blood pressure function that non-invasively measures and displays blood pressure (diastolic, systolic, and mean) and heart rate. In addition, the device measures and displays associated hemodynamic parameters based on calculations of measurements already incorporated into the Cheetah Reliant. These parameters are: Cardiac Index (CI), Ventricular Ejection Time (VET), Total Peripheral Resistance Index (TPRI), Stroke Volume Index (SVI), Stroke Volume Variation (SVV), Cardiac Power (CP), Cardiac Power Index (CPI), electrical impedance of the chest cavity (Z0) and Thoracic Fluid Content (TFC). The Cheetah Reliant with NIBP functionality is intended for use within hospitals and other healthcare facilities (e.g., outpatient clinics) that provide patient care.

The Cheetah Reliant with NIPB functionality is a modification of the Cheetah Reliant device cleared under K072662. The significant modification discussed in this 510(k) submission is the addition of a Non Invasive Blood Pressure (NIBP) module to the system which involved updating the user interface to allow operating the NIBP module and for displaying the results and saving them within the device's database. The NIBP Module is the Advantage mini OEM BP™ module (Model 2 Mini), manufactured by SunTech Medical Inc. (Morrisville, NC, USA). The ADVANTAGE mini OEM BPTM Module Series is an oscillometric OEM blood pressure system. The module is controlled via software commands issued from a host system through an asynchronous serial data port (factory configurable to Logic Level or RS-232). All Module operations must be initiated by the Host system (Reliant). The module is designed to take blood pressure measurements (systolic, diastolic, and heart rate) on demand. After each blood pressure measurement, the Module discards the previous blood pressure results.

The Cheetah NICOM system is a portable, non-invasive Cardiac Output monitoring device based on bio-impedance Cardiography. The Cheetah NICOM system is intended to monitor and display a patient's Cardiac Output in units of Ltr/Min, and was cleared under K042144. NICOM Electrodes are disposable electrodes used in conjunction with the NICOM signal processing product line.

The Cheetah NICOM is a portable, non-invasive, Cardiac Output detector system. The NICOM system measures the Cardiac Output by employing the electrical bio-impedance measurement technique. Electrical bio-impedance is the characteristic impedance of a volume of tissue and fluid. In the case of Cardiac Output measurements, the relevant tissue includes the heart and the immediate surrounding volume of the thorax. The relevant fluid is blood. Cheetah Medical's NICOM electrode is a double electrode sticker. Within each sticker, one electrode is used to inject a high frequency sine wave into the body, while the resulting voltage is measured at the adjacent electrode. An array of such electrodes is placed at specific areas of the thorax, the impedance to the current flow calculated, and the electrical bio-reactance waveform constructed.

The Cheetah Reliant is a portable, non-invasive Cardiac Output monitoring device based on bio-impedance Cardiography. The Cheetah Reliant system is intended to monitor and display a patient's Cardiac Output in units of Ltr/min.

The Cheetah Reliant is a portable, non-invasive, Cardiac Output measurement system. The Cheetah Reliant measures the Cardiac Output by employing the electrical bio-impedance measurement technique. Electrical bio-impedance is the characteristic impedance of a volume of tissue and fluid. In the case of Cardiac Output measurements, the relevant tissue includes the heart and the immediate surrounding volume of the thorax. The relevant fluid is blood.

The Cheetah NICOM system is a portable, non-invasive Cardiac Output monitoring device based on bio-Impedance Cardiography. The Cheetah NICOM system is intended to monitor and display a patient's Cardiac Output in units of [Ltr/Min].

The Cheetah NICOM system is a portable, non-invasive Cardiac Output monitoring device based on bio-Impedance Cardiography.

The Cheetah Integrated Vascular Diagnostic System (I.V.D.S.) is a non-invasive tool intended to detect blood wave front (BWF) delay.

The Cheetah I.V.D.S. is a portable, non-invasive, 4-Channel Cheetah - Blood Wave Front (BWF) detector, with an additional Time Marker channel. The Cheetah channel is intended to measure the time lag between the start of the blood wave front in the peripheral vascular system and the peak of the R-wave on the time marker signal. The Cheetah I.V.D.S. consists of 2 finger probes, 2 toe probes and time marker leads placed on the subject's wrists and legs. The probes are connected to a computer that analyses and presents a print out of the pulse wave as it reaches the periphery. In addition, the Cheetah I.V.D.S. comprises standard Laptop computer connected to conventional analog-to-digital converter, which is used for the analysis and presentation of the acquired data.