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The intended use of the Philips NM3 Respiratory Profile Monitor, Model 7900, is to provide: - cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during general anesthesia and in the intensive care unit (ICU). - spirometric, and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). Separate combination CO2/flow sensors are provided for adult, pediatric and neonatal use. - continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients during both no motion and motion conditions and for patients who are well or poorly perfused during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). The intended use of the VentAssist software option is to provide: - non-invasive monitoring of work of breathing per minute in adult patients receiving pressure support mechanical ventilation. - on-demand advice in mechanically ventilated adult patients as prescribed by the caregiver regarding (a) modifications to the current pressure support settings in order to assess the work of breathing and breathing pattern and (b) modifications to ventilation in order to maintain end-tidal CO2 in a range determined by the physician. The patients should be hemodynamically stable and must be breathing spontaneously.

The NM3 monitor with VentAssist is intended for non-invasive monitoring of the inspired and expired airflow and airway pressure of intensive care unit (ICU), anesthesia and emergency room (ER) patients, as well as capnography and pulse oximetry in all of these clinical settings. It is intended to serve all of the same purposes as the flow, carbon dioxide, pulse oximetry, and cardiac output monitoring components of the predicate NM3 monitor with the addition of the optional VentAssist software. Combination CO2 adapter/flow sensors (neonatal, pediatric, adult), combination adult CO2 adapter/flow sensors with a partial rebreathing valve and flow sensors (infant/neonatal, pediatric/adult) are connected with a male pneumatic connector to the NM3 monitor. Sidestream airway adapters and nasal cannulas are available which are connected with a sample cell connector to a receptacle on the LoFlo Module which can be interfaced to the NM3 monitor. All of these sensors are already legally marketed as accessories of 510(k) cleared Respironics-Novametrix NM3 monitor. The pulse oximetry sensors are connected to the NM3 monitor via a connector on the front panel of the monitor. All of the pulse oximetry sensors are already legally marketed as accessories of the 510(k) cleared NM3 monitor and Masimo predicate devices. The principal function of the flow portion of combination sensors and flow sensors is to provide a differential pressure signal related to flow and airway pressure relative to atmospheric pressure. These sensors are often placed in the breathing circuit between the endotracheal tube and the ventilator circuit Y piece and may also be used in conjunction with a face mask or mouthpiece. The flow measurement portion of the NM3 monitor consists of a microprocessor-based data acquisition system that measures flow, and pressure and interfaces with a Capnostat 5 CO2 sensor. The CO2 airway adapter portion of the combination sensors, allow the Respironics-Novametrix CO2 mainstream gas sensor, the Capnostal® 5, to attach to it and measure the concentration of CO2 in the airway using infrared technology. When CO2 measurements are combined with airway flow and volume measurements, other parameters such as CO2 production and dead space can be calculated in all patient populations. The Capnostat 5 sensor as a mainstream gas analyzer includes a sample cell positioned in the breathing circuit through which a patient's inspiratory and expiratory gases flow. The LoFlo module, a sidestream type of gas analyzer, samples gases at 50 ml/min from a sampling port in an adapter placed in a breathing circuit or from a nasal or oral cannula. The gas then passes through a sampling tube to the sample cell, where the gas components are measured. The combination adult CO2 adapter/flow sensors with a partial rebreathing valve with periodic activation of the rebreathing valve allow pulmonary capillary blood flow and cardiac output to be calculated using the differential Fick method. The VentAssist software option comprises a new screen with a soft key that provides ondemand ventilator-independent open-loop advice with respect to the level of pressure support and ventilation. As an advisory system, the clinician can choose to accept or reject the advice, alleviating any issues of safety and effectiveness. Additionally, an improved method for the calculation of plateau pressure has been included, as well as a new calculated parameter for work of breathing (WOB). The WOB parameter facilitates the goal of reducing excessive work of breathing per minute, or power of breathing (WOB/min), for mechanical ventilatory support in patients with respiratory failure. The WOB/min parameter is implemented using an Artificial Neural Net (ANN) and is used by the PSV Advisor software. The VentAssist PS/V Advisor is a rule based system which provides on-demand advice for the setting of the PSV level and ventilator support levels, based upon WOB/min, breathing frequency, tidal volume, ideal body weight, and end-tidal CO2. The advice is based upon a set of logic rules developed and refined in conjunction with experienced critical care clinicians at teaching University hospitals. Decision support advice offered by the VentAssist software is available during monitoring of adult patients. The monitor uses the sensor-type (adult, pediatric, or neonate), as well as patient data entered into the monitor, to enable appropriate features.