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The intended use of the BEACON Caresystem is to provide - respiratory mechanics monitoring in adult patients in the Intensive Care Unit (ICU) - on-demand ventilator-dependent open-loop advice in mechanically ventilated adult patients as prescribed by the clinician Patients should be hemodynamically stable. The device is intended for use by properly trained clinicians. BEACON Caresystem is for prescription use, only.

BEACON Caresystem is an Intensive Care Unit (ICU) ventilation assist system. BEACON Caresystem will provide ICU clinicians with on-demand ventilator-dependent open-loop advice for ventilating adult patients. BEACON Caresystem uses inputs measured by BEACON Caresystem and data inputs from the ventilator and manual data entry by the clinician into a computer program that has been designed to provide advice for changes to the ventilator settings for the individual patient undergoing mechanical ventilation. BEACON Caresystem is an adjunct to third party legally marketed ICU mechanical ventilators. BEACON Caresystem consists of the following components: - BEACON Display Unit - BEACON Gas Module - BEACON Power Adaptor - NONIN XPOD SpO2 Analyzer BEACON Caresystem utilizes the following cleared accessories: - BEACON Flow Sensor (Adult) private label version of Metaphor E-Z Flow Sensor, Size Adult [K093080] - BEACON Water Trap (Adult) [K182075 & K171292] - NONIN Finger Clip SpO2 sensor NONIN 8000AA1 [K071285] - NONIN Ear Clip SpO2 sensor- NONIN 8000Q2 [K080255] - NONIN Forehead Reflectance SpO2 sensor NONIN 8000R [K071285] The BEACON Display Unit is a standard off-the-shelf tablet touch-screen computer. The BEACON display unit connects through a USB port to the NONIN XPOD SpO2 analyzer for pulse oximetry measurements and serial data ports for connection to the BEACON Gas Module and the connected ICU ventilator. The BEACON Display unit includes the BEACON Caresystem Software. The BEACON Gas Module performs measurement of patient airway flow and inspired and expired fractions of CO2 and O2 in the airway. As described above, BEACON Caresystem combines the functionalities of a spirometric monitor, respiratory gas monitor, and pulse oximeter. Each of these functions, respectively, is intended for: - Respiratory mechanics monitoring (i.e. airway flow/volume) - Measurement of expired and inspired breathing gases (CO2, O2) and respiration rate - Non-invasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The BEACON Caresystem Software utilizes the monitored parameters above with data from the connected ICU ventilator and clinician entered values to generate on demand, open-loop advice for changes to the ventilator settings for an adult patient undergoing mechanical ventilation.

ExSpiron 2Xi is indicated for use by healthcare professionals in healthcare facilities, such as post-operative care and critical care units, to monitor breathing in patients at least 1 - year of age. ExSpiron 2Xi is a non-invasive monitor that graphically displays lung volume against time and reports an approximate value of: - Minute Ventilation (MV) - Tidal volume (TV) - Respiratory Rate (RR) ExSpiron 2Xi measurements are used as an adjunct to other clinical information.

The ExSpiron 2Xi Respiratory Monitor System consists of: Monitor: The Monitor contains a bioimpedance measurement system and a tablet PC housed within a single enclosure. Bioimpedance measurement system: The Monitor incorporates a stabilized high frequency current generator and an adaptive circuit that conditions the resulting voltage signal and converts it to digital form. Firmware within the Monitor performs signal acquisition and relays data to the tablet PC. Computer: A tablet PC performs signal processing and calibration and runs the graphical user interface (GUI). The PC takes user input from a touch screen through a virtual keyboard and mouse. The GUI is used for recording patient data and displaying the respiratory trace as well as scalar values and trends for minute ventilation, tidal volume, and respiratory rate. Patient Cables and Electrode Padsets that are also included in the system but were cleared in previous 510(k)s: K130170, K162131, K173181 ExSpiron Patient Cable: A reusable cable that connects the ExSpiron 2Xi Monitor to the Electrode PadSet. Single patient use ExSpiron Electrode PadSet: A Single-Patient Use Electrode PadSet is placed on the skin of the patient's torso. It delivers current to, and records impedance measurements from, the skin.

The indications for use for the Gas Module 3 include monitoring of airway gases during anesthesia and/or assisted respiration. The intended environment of use is the anesthesia department, including the Operating Room (OR) and post anesthesia care units (PACU), etc.

The Gas Module 3 is an independently powered unit capable of interfacing with Mindray DS USA, Inc. (hereafter MRDS) Patient Monitors using a proprietary communications protocol. The system connects to the patient monitor via a RS232 connector. All Gas Module 3 data display on the monitor screen. And all user commands are entered on the monitor and then electronically transmitted to the Gas Module 3. The Gas Module 3 measures in real-time, breath-by-breath CO2, O2, N2O gases. Additionally, the Gas Module 3 monitors the anesthetic agents Halothane (HAL), Isoflurane (ISO), Sevoflurane (SEV), Desflurane (DES) and Enflurane (ENF). The Gas Module 3 consists of AION Multigas Analyzer, Servomex Paramagnetic Oxygen sensor, Power supply Board and Communication Board. The subject device is a modified version of a previously cleared model, the Gas Module SE. The Gas Module SE was cleared under K062754, on September 13, 2006.

ExSpiron 1Xi is indicated for use by healthcare professionals in healthcare facilities, such as post-operative care and critical care units, to monitor breathing in patients at least one year of age. ExSpiron 1Xi is a non-invasive monitor that graphically displays lung volume against time and reports an approximate value of: * Minute Ventilation (MV) * Tidal volume (TV) * Respiratory rate (RR) ExSpiron 1Xi measurements are used as an adjunct to other clinical information.

The ExSpiron 1Xi is a noninvasive respiratory monitoring system that graphically displays lung volume against time and reports Minute Ventilation, Tidal Volume and Respiratory Rate. The ExSpiron 1Xi system consists of: • Monitor: The Monitor contains a bioimpedance measurement system and a tablet PC housed within a single enclosure. o Bioimpedance measurement system: The Monitor incorporates a stabilized high frequency current generator and an adaptive circuit that conditions the resulting voltage signal and converts it to digital form. Firmware within the Monitor performs signal acquisition and relays data to the tablet PC. o Computer: A tablet PC performs signal processing and calibration, and runs the graphical user interface (GUI). The PC takes user input from a touch screen through a virtual keyboard and mouse. The GUI is used for recording patient data and displaying the respiratory trace as well as scalar values and trends for minute ventilation, tidal volume, and respiratory rate. There are no hardware changes included in this submission. Single-Patient Use ExSpiron Electrode PadSet: • A Single-Patient Use Electrode PadSet is placed on the skin of the patient's torso. It delivers current to, and records impedance measurements from, the skin. The Electrode PadSet for the ExSpiron 1Xi is identical to that cleared for the Predicate device.

ExSpiron 1Xi is indicated for use by healthcare professionals in healthcare facilities, such as post-operative care and critical care units, to monitor breathing in adult (at least 21 years old) patients. ExSpiron 1Xi is a non-invasive monitor that graphically displays lung volume against time and reports an approximate value of: * Minute Ventilation (MV) * Tidal volume (TV) * Respiratory rate (RR) ExSpiron 1Xi measurements are used as an adjunct to other clinical information.

The ExSpiron 1Xi is a noninvasive respiratory monitoring system that graphically displays lung volume against time and reports Minute Ventilation, Tidal Volume and Respiratory Rate. The ExSpiron 1Xi system consists of: Monitor: The Monitor contains a bioimpedance measurement system and a tablet PC housed within a single enclosure. Bioimpedance measurement system: The Monitor incorporates a stabilized high frequency current generator and an adaptive circuit that conditions the resulting voltage signal and converts it to digital form. Firmware within the Monitor performs signal acquisition and relays data to the tablet PC. Computer: A tablet PC performs signal processing and calibration, and runs the graphical user interface (GUI). The PC takes user input from a touch screen through a virtual keyboard and mouse. The GUI is used for recording patient data and displaying the respiratory trace as well as scalar values and trends for minute ventilation, tidal volume, and respiratory rate. A Single-Patient Use Electrode PadSet is placed on the skin of the patient's torso. It delivers current to, and records impedance measurements from, the skin. The Electrode PadSet for the ExSpiron 1Xi is identical to that cleared for the Predicate device.

ExSpiron 1xi is indicated for use by healthcare professionals in healthcare facilities, such as post-operative care and critical care units, to monitor breathing in adult (at least 21 years old) patients. ExSpiron 1xi is a non-invasive system that graphically displays lung volume against time and reports an approximate value of: Tidal volume, Respiratory rate, and Minute ventilation ExSpiron 1xi measurements are used as an adjunct to other clinical information sources.

The ExSpiron 1xi system consists of: Bioimpedance measurement system: A stabilized high frequency current generator is connected to two outer electrodes. The inner four electrodes are connected to an adaptive circuit that conditions the resulting voltage signal and converts it to digital form. Firmware performs signal acquisition and relays data to the panel PC. Computer: A Windows 7 PC performs signal processing and calibration, and runs the graphical user interface (GUI). The PC takes user input from a touch screen. The GUI is used for recording patient data and displaying the respiratory trace as well as scalar values and trends for minute volume, tidal volume, and respiratory rate. Single Patient Use ExSpiron™ 1xi Electrode PadSet: An electrode assembly containing six electrodes to be placed on the torso. It delivers current and records impedance measurements. The electrode PadSet is also used to perform subsystem checks prior to patient measurements.

ExSpiron is indicated for use by healthcare professionals in healthcare facilities, such as post-operative care and critical care units, to monitor breathing in adult (at least 21 years of age) patients. ExSpiron is a non-invasive system that graphically displays lung volume against time and reports an approximate value of: - Tidal volume, . - . Respiratory rate, and - Minute ventilation. ● ExSpiron measurements are used as an adjunct to other clinical information sources.

The ExSpiron™ consists of: Bioimpedance measurement system: A stabilized high frequency current generator is connected to two outer electrodes. The inner four electrodes are connected to an adaptive circuit that conditions the resulting voltage signal and converts it to digital form. Firmware performs signal acquisition and relays data to the panel PC. Panel PC: A Windows 7 PC performs signal processing and calibration, and runs the graphical user interface (GUI). The PC takes user input from a touch screen through a virtual keyboard and mouse. The GUI is used for recording patient data and displaying the respiratory trace as well as scalar values and trends for minute volume, tidal volume, and respiratory rate. Single Patient Use ExSpiron™ Electrode Lead Set: An electrode lead set containing six electrodes to be placed on the torso. It delivers current and records impedance measurements. The electrode lead set is also used to perform subsystem checks prior to patient measurements.

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.

The intended use of the Wright/Haloscale Respirometer is the measurement and monitoring of the level of lung ventilation achieved by intensive care patients, during anesthesia and post operative recovery. It measures expired volumes and thus indicates whether adequate ventilation is being achieved, whether in open or closed circuit or spontaneously breathing or mechanically ventilated patients.

The Respirometer is a mechanically driven dial, where the dial indicates gas volume passed, and the mechanism is driven by the kinetic energy in the flowing gas. The device measures expirate gas flow and measurements are unaffected by inspirate gas flow. It has an on/off button to lock the pointer and a reset button to return the pointer to zero when it approaches full scale

The intended use of the Mercury module with Capnostat 5 is to provide: - 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.

The Mercury module with Capnostat 5 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 in all of these clinical settings. It is intended to serve the same purposes as the Mercury module with Capnostat 5. The submitted Mercury module with Capnostat 5 is identical to the cleared Mercury Module with Capnostat 5 CO2 sensor. except the nominal upper limit for the specification for the neonatal flow and neonatal CO2/flow sensors used with the Mercury module has been increased from 25 to 30 LPM to align with the specification for maximum inspiratory flow for ventilators cleared for use with neonates. The Mercury module with Capnostat 5 is intended to provide continuous monitoring of respiratory flow and pressure, and CO2 during anesthesia and intensive care and in the emergency department. The flow sensors connect to a patient airway circuit and provide physiological information to the Mercury module. The parameters directly measured and computed by the module (when connected to a Capnostat 5 sensor) include airway flow and pressure, volume, and CO2. The monitor calculates flow by measuring the pressure drop across a known resistance placed in the breathing circuit. CO2 is measured as the absorption of a known intensity of infrared light by CO2 molecules in the airway.