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The T3 Platform™ software features the T3 Data Aggregation & Visualization software module version 5.0 and the T3 Risk Analytics Engine software module version 9.0. The T3 Data Aggregation & Visualization software module is intended for the recording and display of multiple physiological parameters of the adult, pediatric, and neonatal patients from supported bedside devices. The software module is not intended for alarm notification or waveform display, nor is it intended to control any of the independent bedside devices to which it is connected. The software module is intended to be used by healthcare professionals for the following purposes: - To remotely consult regarding a patient's status, and - To remotely review other standard or critical near real-time patient data in order to aid in clinical decisions and deliver patient care in a timely manner. The T3 Data Aggregation & Visualization software module can display numeric physiologic data captured by other medical devices: - · Airway flow, volume, and pressure - · Arterial blood pressure (invasive and non-invasive, systolic, diastolic, and mean) - Bispectral index (BIS, signal quality index, suppression ratio) . - Cardiac Index - Cardiac output . - Central venous pressure . - . Cerebral perfusion pressure - End-tidal CO2 . - · Heart rate - Heart rate variability . - Intracranial pressure . - . Left atrium pressure - Oxygen saturation (intravascular, regional, SpO2) . - Premature ventricular counted beats . - Pulmonary artery pressure (systolic, diastolic, and mean) . - Pulse pressure variation - · Pulse Rate - · Respiratory rate - Right atrium pressure . - Temperature (rectal, esophageal, tympanic, blood, core, nasopharyngeal, skin) - · Umbilical arterial pressure (systolic, diastolic, and mean) The T3 Data Aggregation & Visualization software module can display laboratory measurements including arterial and venous blood gases, complete blood count, and lactic acid. T3 Data Aggregation & Visualization software module can display information captured by the T3 Risk Analytics Engine software module. The T3 Risk Analytics Engine software module calculates four indices: the IDO2 Index™ for inadequate delivery of oxygen, the IVCO2 Index™ for inadequate ventilation of carbon dioxide, the ACD Index™ for acidemia, and the HLA Index™ for hyperlactatemia. The IDO2 Index™ is indicated for use by health care professionals with post-surgical patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The IDO2 Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation & Visualization software module. When the IDO2 Index™ is increasing, it means that there is an increasing risk of inadequate oxygen delivery and attention should be brought to the patient. The IDO2 Index™ presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements. The IVCO2 Index™ is indicated for use by health care professionals with invasively ventilated patients 0 to 12 years of age under intensive care. The IVCO2 Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation and Visualization software module. When the IVCO2 Index™ is increasing, it means that there is an increasing risk of inadequate carbon dioxide ventilation and attention should be brought to the patient. The IVCO2 Index™ presents partial quantitative information about the patient's respiratory condition, and no therapy or drugs can be administered based solely on the interpretation statements. The ACD Index™ is indicated for use by health care professionals with invasively ventilated patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The ACD Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation and Visualization software module. When the ACD Index™ is increasing, it means that there is an increasing risk of acidemia and attention should be brought to the patient. The ACD Index™ presents partial quantitative information about the patient's respiratory condition, and no therapy or drugs can be administered based solely on the interpretation statements. The HLA Index™ is indicated for use by health care professionals with post-surgical patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The HLA Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation & Visualization software module. When the HLA Index™ is increasing, it means that there is an increasing risk of hyperlactatemia and attention should be brought to the patient. The HLA Index™ presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements.

The Tracking, Trajectory, Trigger (73) intensive care unit software solution allows clinicians and quality improvement teams in the ICU to aggregate data from multiple sources, store it in a database for analysis, and view the streaming data. System features include: - Adjunctive status indicators ● - Customizable display of physiologic parameters over the entire patient stay - . Configurable annotation - Web-based visualization that may be used on any standard browser - Minimal IT footprint ● - Software-only solution no new bedside hardware required ● - Highly reliable and robust operation - . Auditable data storage

The T3 Platform™ software features the T3 Data Aggregation & Visualization software module version 5.0 and the T3 Risk Analytics Engine software module version 8.0. The T3 Data Aggregation & Visualization software module is intended for the recording and display of multiple physiological parameters of the adult, pediatric, and neonatal patients from supported bedside devices. The software module is not intended for alarm notification or waveform display, nor is it intended to control any of the independent bedside devices to which it is connected. The software module is intended to be used by healthcare professionals for the following purposes: - To remotely consult regarding a patient's status, and - To remotely review other standard or critical near real-time patient data in order to aid in clinical decisions and deliver patient care in a timely manner. The T3 Data Aggregation & Visualization software module can display numeric physiologic data captured by other medical devices: - Airway flow, volume, and pressure - Arterial blood pressure (invasive and non-invasive, systolic, diastolic, and mean) - Bispectral index (BIS, signal quality index, suppression ratio) . - Cardiac Index - . Cardiac output - Central venous pressure . - . Cerebral perfusion pressure - End-tidal CO2 . - · Heart rate - Heart rate variability . - Intracranial pressure . - . Left atrium pressure - Oxygen saturation (intravascular, regional, SpO2) . - Premature ventricular counted beats . - · Pulmonary artery pressure (systolic, diastolic, and mean) - Pulse pressure variation - · Pulse Rate - · Respiratory rate - Right atrium pressure . - Temperature (rectal, esophageal, tympanic, blood, core, nasopharyngeal, skin) - · Umbilical arterial pressure (systolic, diastolic, and mean) The T3 Data Aggregation & Visualization software module can display laboratory measurements including arterial and venous blood gases, complete blood count, and lactic acid. T3 Data Aggregation & Visualization software module can display information captured by the T3 Risk Analytics Engine software module, The T3 Risk Analytics Engine software module calculates four indices: the IDO2 Index™ for inadequate delivery of oxygen, the IVCO2 Index™ for inadequate ventilation of carbon dioxide, the ACD Index™ for acidemia, and the HLA Index™ for hyperlactatemia. The IDO2 Index™ is indicated for use by health care professionals with post-surgical patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The IDO2 Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation & Visualization software module. When the IDO2 Index™ is increasing, it means that there is an increasing risk of inadequate oxygen delivery and attention should be brought to the patient. The IDO2 Index™ presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements. The IVCO2 Index™ is indicated for use by health care professionals with invasively ventilated patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The IVCO2 Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation and Visualization software module. When the IVCO2 Index™ is increasing, it means that there is an increasing risk of inadequate carbon dioxide ventilation and attention should be brought to the IVCO2 Index™ presents partial quantitative information about the patient's respiratory condition, and no therapy or drugs can be administered based solely on the internets. The ACD Index™ is indicated for use by health care professionals with invasively ventilated patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The ACD Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation and Visualization software module. When the ACD Index™ is increasing, it means that there is an increasing risk of acidemia and attention should be brought to the patient. The ACD Index™ presents partial quantitative information about the patient's respiratory condition, and no therapy or drugs can be administered based solely on the interpretation statements. The HLA Index™ is indicated for use by health care professionals with post-surgical patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The HLA Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation & Visualization software module. When the HLA Index™ is increasing, it means that there is an increasing risk of hyperlactaternia and attention should be brought to the patient. The HLA Index™ presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements.

The Tracking, Trajectory, Trigger (73) intensive care unit software solution allows clinicians and quality improvement teams in the ICU to aggregate data from multiple sources, store it in a database for analysis, and view the streaming data. System features include: - Adjunctive status indicators - Customizable display of physiologic parameters over entire patient stay - Configurable annotation - Web-based visualization that may be used on any standard browser - Minimal IT footprint - Software-only solution no new bedside hardware required - Highly reliable and robust operation - Auditable data storage

The T3 Data Aggregation & Visualization software module is intended for the recording and display of multiple physiological parameters of the adult, pediatric, and neonatal patients from supported bedside devices. The software module is not intended for alarm notification or waveform display, nor is it intended to control any of the independent bedside devices to which it is connected. The software module is intended to be used by healthcare professionals for the following purposes: To remotely consult regarding a patient's status, and To remotely review other standard or critical near real-time patient data in order to aid in clinical decisions and deliver patient care in a timely manner. The T3 Data Aggregation & Visualization software module can display numeric physiologic data captured by other medical devices: Airway flow, volume, and pressure Arterial blood pressure (invasive and non-invasive, systolic, diastolic, and mean) Bispectral index (BIS, signal quality index, suppression ratio) Cardiac Index Cardiac output Central venous pressure Cerebral perfusion pressure End-tidal CO2 Heart rate Heart rate variability Intracranial pressure Left atrium pressure Oxygen saturation (intravascular, regional, SpO2) Premature ventricular counted beats Pulmonary artery pressure (systolic, diastolic, and mean) Pulse pressure variation Pulse Rate Respiratory rate Right atrium pressure Temperature (rectal, esophageal, tympanic, blood, core, nasopharyngeal, skin) Umbilical arterial pressure (systolic, diastolic, and mean) The T3 Data Aggregation & Visualization software module can display laboratory measurements including arterial and venous blood gases, complete blood count, and lactic acid. T3 Data Aggregation & Visualization software module can display information captured by the T3 Risk Analytics Engine software module. The T3 Risk Analytics Engine software module calculates two indices: the IDO2 Index™ for inadequate delivery of oxygen and the IVCO2 Index™ for inadequate ventilation of carbon dioxide. IDO2 Index™ is indicated for use by health care professionals with post-surgical patients aged zero days to twelve years weighing 2 kg or more under intensive care. IDO2 Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation & Visualization software module, version 5.0 or higher. When the IDO2 Index™ is increasing, it means that there is an increasing risk of inadequate oxygen delivery and attention should be brought to the IDO2 Index™ presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements. IVCO2 Index™ is indicated for use by health care professionals with invasively ventilated patients aged 29 days to 12 years weighing 2 kg or more under intensive care. IVCO2 Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation and Visualization software module, version 5.0 or higher. When the IVCO2 Index™ is increasing, it means that there is an increasing risk of inadequate carbon dioxide ventilation and attention should be brought to the IVCO2 Index™ presents partial quantitative information about the patient's respiratory condition, and no therapy or drugs can be administered based solely on the interpretation statements.

The Tracking, Trajectory, Trigger (T3) intensive care unit software solution allows clinicians and quality improvement teams in the ICU to aggregate data from multiple sources, store it in a database for analysis, and view the streaming data. System features include: Customizable display of physiologic parameters over entire patient stay, Configurable annotation, Web-based visualization that may be used on any standard browser, Minimal IT footprint, Software-only solution - no new bedside hardware required, Highly reliable and robust operation, Auditable data storage.

The T3 Data Aggregation & Visualization software module is intended for the recording and display of multiple physiological parameters of the adult, pediatric, and neonatal patients from supported bedside devices. The software module is not intended for alarm notification or waveform display, nor is it intended to control any of the independent bedside devices to which it is connected. The software module is intended to be used by healthcare professionals for the following purposes: · To remotely consult regarding a patient's status, and • To remotely review other standard or critical near real-time patient data in order to aid in clinical decisions and deliver patient care in a timely manner. The T3 Data Aggregation & Visualization software module can display numeric physiologic data captured by other medical devices: - · Airway flow, volume, and pressure - · Arterial blood pressure (invasive and non-invasive, systolic, diastolic, and mean) - · Bispectral index (BIS, signal quality index, suppression ratio) - Cardiac Index - Cardiac output - Central venous pressure - · Cerebral perfusion pressure - · End-tidal CO2 - · Heart rate - · Heart rate variability - · Intracranial pressure - Left atrium pressure - · Oxygen saturation (intravascular, regional, SpO2) - · Premature ventricular counted beats - · Pulmonary artery pressure (systolic, diastolic, and mean) - · Pulse pressure variation - · Pulse Rate - · Respiratory rate - · Right atrium pressure - · Temperature (rectal, esophageal, tympanic, blood, core, nasopharyngeal, skin) - · Umbilical arterial pressure (systolic, diastolic, and mean) The T3 Data Aggregation & Visualization software module can display laboratory measurements including arterial and venous blood gases, complete blood count, and lactic acid. The T3 Data Aggregation & Visualization software module can display information captured by the T3 Risk Analytics Engine software module. The T3 Risk Analytics Engine software module calculates two indices: the IDO2 Index™ for inadequate delivery of oxygen and the IVCO2 Index™ for inadequate ventilation of carbon dioxide. IDO2 Index™ is indicated for use by health care professionals with post-surgical patients aged zero days to twelve years weighing 2 kg or more under intensive care. IDO2 Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation & Visualization software module, version 3.3 or higher. When the IDO2 Index™ is elevated. it means that there is an increased risk of inadequate oxygen delivery and attention should be brought to the IDO2 Index™ presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements. IVCO2 Index™ is indicated for use by health care professionals with invasively ventilated patients aged 29 days to 12 years weighing 2 kg or more under intensive care. IVCO2 Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation and Visualization software module, version 3.3 or higher. When the IVCO2 Index™ is increasing, it means that there is an increasing risk of inadequate carbon dioxide ventilation and attention should be brought to the patient.

The Tracking, Trajectory, Trigger (73) intensive care unit software solution allows clinicians and quality improvement teams in the ICU to aggregate data from multiple sources, store it in a database for analysis, and view the streaming data in real-time. System features include: - Customizable display of physiologic parameters over entire patient stay - Configurable annotation - Web-based visualization that may be used on any standard browser ● - . Minimal IT footprint - Software-only solution no new bedside hardware required . - . Highly reliable and robust operation - Auditable data storage This release of the T3 Platform Software contains the following software module changes: T3 Risk Analytics Engine software module version 5.0 1) IVCO2 Index™. The subject device is a modification of the T3 Platform software clearance under K163065 that expands the Indications for Use for inadequate ventilation of carbon dioxide index (IVCO2 Index™). The IVCO2 Index™ calculates a patient status index. This is a measure of the likelihood that an arterial blood gas measurement of carbon dioxide would indicate a partial pressure greater than 50 mmHg. 2) Minor changes to maintain the performance of the IDO2 Index™ when external factors exist. Minor changes to the IDO2 Index™ have been made to maintain the specified performance of the IDO2 Index™ when variations in external factors exist. Specifically, these included changes in the initialization routine to ensure that the algorithm converges to stable behavior within the required time window, and changes in the artifact rejection logic of noninvasive blood pressure measurements to ensure that these measurements are not ignored when only minimum data is available thus providing required minimum data performance. T3 Data Aggregation & Visualization software module version 3.3 1) Index Displayed on Census View. IDO2 Index™ and the IVCO2 Index™ are not displayed on the Census View and the requirement was removed. 2) Blackout. To mitigate potential misuse of active patient monitoring with Persistent Displays in the ICU, the IDO2 Index™ and the IVCO2 Index™ are blacked out in the near-real-time, a warning label is placed above the Index, and a user is prompted to acknowledge warnings when selecting an Index to be graphed. 3) Measure synonyms. Certain measures, while not identical to each other, are nevertheless closely related and can be thought of as "synonyms" for each other. For example, "Temp" (Generic Temperature), "Tairwy" (Airway Temperature), "Tesoph" (Esophogeal Temperature), and "Ttymp" (Tympanic Temperature) are all measures of the patient's temperature. In this example, the measure synonym feature would allow T3 Data Aggregation & Visualization software module to continuously report a value for "Temperature" based on whatever values were being received for Temp, Tairwy, Tesoph and/or Ttymp. The raw (source) variables continue to be available to be seen or graphed. In addition, this feature includes an "explain" function that allows the clinician to examine measure synonyms to see the source of the displayed data value at each moment in time. 4) Respiratory View. T3 Data Aggregation & Visualization software module now includes a screen that displays measures and laboratory results related to the patient's respiratory system. This predefined arrangement, accessed by clicking on the "Respiratory" tab beside the previously released "Hemodynamic" view, saves the clinician the time and effort of graphing these laboratory data and measures in order to understand the status and trend of the patient's respiratory system. The respiratory view includes Smart Visualization Groups that show measures and labs related to respiratory rate, ventilation pressure, respiratory volume, oxygenation, and ventilation. 5) Placement of IDO2 at the top of the Patient View. In the T3 Data Aggregation & Visualization software module, the display canvas for IDO2 Index™ has been moved to the top of the Patient View. 6) Current measure value is shown on the graph instead of the legend. When the user positions the mouse cursor in the central graph area, T3 Data Aggregation & Visualization software module displays the value of all graphed measures for the time corresponding to the cursor location. Previous releases of T3 Data Aggregation & Visualization software module displayed this information on the legend (the label for each measure or laboratory result that is shown to the left of the graph area). This release of T3 Data Aggregation & Visualization software module instead shows the value beside a light vertical line that is drawn at the mouse cursor position. This moves the information closer to the user's focus of attention (the mouse cursor). 7) Ability to receive and merge multiple data interfaces of the same type. T3 Data Aggregation & Visualization software module currently receives three types of data interfaces: patient registration (ADT), laboratory results, and physiometric data. This release allows T3 Data Aggregation & Visualization software module to receive and merge data interfaces of the same type coming from two or more sources. For example, a physiometric data interface for beds from a particular floor of the hospital can now be merged with a separate physiometric data interface with beds from a different floor or unit. This feature allows clinicians to view collections of beds that correspond to patient care trajectories such as the operating room and recovery unit, or intensive care and step-down unit. 8) Ability to receive data through SQL relational database query. Previous releases of T3 Data Aggregation & Visualization software module received data exclusively through HL7-based data interfaces. However, depending on a hospital's IT infrastructure, data from peripheral devices like ventilators may be sent to the hospital electronic medical record but not broadcast through an HL7 data interface. This release of T3 Data Aggregation & Visualization software module retains its HL7 functionality, but also supplements it with the ability to simultaneously receive other data through periodic SQL relational database queries. (SQL, structured query language, is the ANSI standard language for relational database management systems). For example, T3 Data Aggregation & Visualization software module can query a hospital database periodically to read validated ventilator values that are not otherwise transmitted through HL7 data interfaces, while simultaneously receiving device and lab data through HL7. 9) Support for an expanded number of beds. This release of T3 Platform software of T3 web server to support up to 128 intensive-care beds. Previously an instance of T3 web server could only support 30 intensive-care beds. The server-side hardware requirements have been modified to request additional hard disk space for T3 web server to support more beds.

The T3 Software is intended for the recording and display of multiple physiological parameters of adult, pediatric and neonatal patients from supported bedside devices. T3 is not intended for alarm notification or waveform display, nor is it intended to control any of the independent bedside devices to which it is connected. T3 is intended to be used by healthcare professionals for the following purposes: - To remotely consult regarding a patient's status, and - To remotely review other standard or critical near real-time patient data in order to aid in clinical decisions and deliver patient care in a timely manner. T3 can display numeric physiologic data captured by other medical devices: - Airway flow, volume and pressure - Arterial blood pressure (invasive and non-invasive, systolic, diastolic, and mean) - Bispectral index (BIS, signal quality index, suppression ratio) - Cardiac Index - Cardiac output - Central venous pressure - Cerebral perfusion pressure - End-tidal CO2 - Heart rate - Heart rate variability - Intracranial pressure - Left atrium pressure - Oxygen saturation (intravascular, regional, SpO2) - Premature ventricular counted beats - Pulmonary artery pressure (systolic, diastolic, and mean) - Pulse pressure variation - Pulse Rate - Respiratory rate - Right atrium pressure - Temperature (rectal, esophageal, tympanic, blood, core, nasopharyngeal, skin) - Umbilical arterial pressure (systolic, diastolic, and mean) It can also display laboratory measurements including arterial and venous blood gases, complete blood count, and lactic acid. T3 includes a Patient Risk Analytics Engine that calculates an index (the Inadequate Oxygen Delivery Index) that is indicated for use by health care professionals with postsurgical patients aged zero days to twelve years weighing 2 kg or more under intensive care. The Inadequate Oxygen Delivery Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by T3. When the index is elevated, it means that there is increased risk of inadequate oxygen delivery and attention should be brought to the patient. The index presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements.

The Tracking, Trajectory, Trigger (T3) intensive care unit software solution allows clinicians and quality improvement teams in the ICU to aggregate data from multiple sources, store it in a database for analysis, and view the streaming data in real-time. System features include: - Customizable display of physiologic parameters over entire patient stay. - Configurable annotation. - Web-based visualization that may be used on any standard browser. - Minimal IT footprint. - Software-only solution no new bedside hardware required. - Highly reliable and robust operation. - Auditable data storage. The subject device is a modification of the T3 Software that expands the Indications for Use for the Inadequate Oxygen Delivery Index (IDO2) from patients aged 0 - 28 days to patients aged zero days to twelve years. The IDO2 Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by T3. This index provides an interpretation of how different the patient's physiologic measures are from normality. In addition to the expansion in the Indications of Use for the IDO2 Index, T3 release 3.0 contains the following changes: - 1) In previous T3 versions, the Inadequate Oxygen Delivery Index is documented as having the following limitation. The index will not be displayed if the following minimum measurements are not available: - a. Heart rate from ECG or pulse at a minimum of once every 30 seconds - b. SpO2 from pulse oximetry at a minimum of once every 30 seconds - c. Blood Pressure (mean/diastolic/systolic) at a minimum of once every 10 minutes This limitation has been changed to the following: The index will not be displayed if the following minimum measurements are not available: - a. Heart rate from ECG or pulse at a minimum of once every 60 seconds - b. SpO2 from pulse oximetry at a minimum of once every 10 minutes - c. Blood Pressure (mean/diastolic/systolic) at a minimum of once every 10 minutes The minimum requirement for Heart Rate data has changed from 30 seconds to 60 seconds, and the minimum requirement for SpO2 has changed from 30 seconds to 10 minutes. - 2) In previous T3 versions, the software model used to calculate IDO2 had age independent parameters and did not include a number of potentially useful model relationships. In the updated model, parameters are now dependent on patient age. Also, new model states and relationships have been implemented to improve the performance. - 3) In previous T3 versions, the calibration logic for IDO2 utilized the probability distribution of patient states to determine whether or not to display a given IDO2 value. The new calibration logic is simply time based, waiting 5 minutes to display IDO2 values for a new patient. In addition, if the algorithm is re-initialized for any reason, it will undergo an additional 5 minutes of calibration after the re-initialization. - 4) The IDO2 labeling contains a list of required and optional algorithm inputs. One required input is SpO2. Previous releases of T3 accepted SpO2 captured by the patient monitor and reported with any of three different labels: "SpO2" (defined as "SpO2 from pulse oximeter"), "SpO2 l" (defined as "arterial oxygen saturation left"), and "SpO2 r" (defined as "arterial oxygen saturation right"). This release of T3 adds SpO2 as reported with two other labels: "SpO2 pr" (defined as "pre-ductal SpO2") and "SpO2 po" (defined as "post-ductal SpO2"). - 5) T3 version 3.0 also includes the following User Interface changes: - a. A new user interface mode that displays the data originating from a single bed location, even as new patients are transferred into that location. The benefit of this change is that the T3 user is never auto-logged off due to inactivity. Instead, T3 displays either the view of the patient data or a dialog stating that no data is being received for the bed. The mode is suitable for a bedside display, and saves clinicians the time and effort of logging in and navigating to that patient's data each time they want to use T3. To mitigate possible clinician confusion about which patient the data is for, T3 only displays data for one patient at a time - the current patient. Furthermore, the patient's name, medical record number and date of birth are displayed on the screen. - b. Views: These are predefined arrangements of labs and measures. Views are accessed through a tabbed display. The first instance of the View functionality is the Hemodynamic View, which presents information about the patient's hemodynamic system. Views save clinicians the time and effort to drag meaningful labs and measures to the central graph area in order to display them. - c. Smart Visualization Groups: These are collections of measures and laboratory results that are graphed together as a single unit. T3 is able to insert shading, vertical lines and other visual cues to emphasize relationships in the data. For example, in the Blood Pressure group, the area between systolic and diastolic pressure is shaded. The shading represents "pulse pressure," a standard measure of the force the heart generates each time it contracts. The shading allows the clinician to see increases or decreases in pulse pressure, in addition to the systolic and diastolic blood pressure values from which pulse pressure is calculated. - d. When T3 displays a measure it inserts the starting and ending values for the period of time being graphed on the left and right edges of the canvas. It inserts the maximum and minimum values for the measure in circles at the point in time when they occur. If two or more of these values would overlap on the graph, T3 omits all but one of them for clarity. Likewise, if one of these values would obscure the graphic icon for a laboratory result, T3 omits it so the laboratory result is shown. - e. Night Mode. There are now application-wide configuration settings that specify when "night time" starts and ends. For example, night time can be defined to start at 7PM and end at 7AM - or whatever times are desired. When T3 runs "at night," the application recognizes that it is night based on the system clock, and automatically uses a dark background. This reduces the amount of ambient light that the T3 monitor emits. When it runs during the day, T3 similarly recognizes that it is day and automatically uses a light background. It is possible for individual users to manually override the night mode function. On the patient view screen, T3 adds buttons that let the user manually control night mode. There is a sunshine button that lightens the background, and a moon button that darkens the background. A lock button locks in the user's selection of day or night. - f. If T3 receives data for a patient measure whose unit of measure is different from what was previously received for that patient and measure, it now displays a temporary warning banner at the top of the display that is automatically dismissed after ten seconds. Previously, T3 displayed the warning, but required the user to dismiss it by clicking on it. In many situations, needing to click to dismiss the warning was inconvenient or impractical. An example of this functionality is if T3 is receiving mean airway pressure for a patient. The monitor may report values in "millibars" then switch to "cmH2O." Both are commonly accepted ways of measuring airway pressure. In this case, the warning will say "Measure mnAWp has inconsistent unit codes. T3 is expecting units of mbar, but received data points with units of cmH2O. Those data points will not be displayed." - g. The dialog showing additional details for a lab value is now invoked by clicking anywhere on the lab icon. Previously it was invoked by hovering the mouse cursor over the exact data point for the lab value. The new functionality is more forgiving if the mouse cursor is slightly misplaced, and is less susceptible to displaying unwanted tooltips when the user moves the mouse cursor around the screen. - 6) Typically, a clinician enters the patient's medical record number (MRN) into the bedside monitor. The physio interface sent to T3 from that monitor then includes the MRN and bed location along with the data values for the patient. T3 now supports an alternate workflow where the hospital's Admit, Discharge and Transfer (ADT) interface is used as the definitive source of patient identity and location information. The physio interface contains bed location along with the data values for the patient, but T3 derives the MRN by matching the bed location sent in the physio interface with the bed location / MRN pairing sent in the ADT interface. In order to recover from a situation where an ADT message is not delivered to T3 for some reason, or T3 processes it incorrectly, there is also a user interface in T3 that allows an administrator to explicitly specify the MRN for the patient occupying a bed location. This has the same effect as an ADT message associating a patient with a bed location. - 7) T3 can now send an informational email to one or more configured email addresses when it detects that data is being received from a bed location without an associated patient medical record number, or when it detects that data is simultaneously being received from multiple bed locations with the same associated MRN. The recipient of the email can then investigate and correct the problem. The email does not contain protected health information; instead it specifies the bed locations where the issue occurs. - 8) The T3 labeling lists a series of clinical calculations that can be configured upon clinician demand. These clinical calculations are simple algebraic formulas that accept raw parameters and output a single result. An example is Pulse Width which is equal to Systolic blood pressure minus Diastolic blood pressure. This release of T3 adds the following calculations to the list that may be requested by clinicians: | Label | Name | Formula | |---|---|---| | P/F | P/F Ratio | PaO2 / FiO2 | | S/F | S/F Ratio | SpO2 / FiO2 | | OI | Oxygenation Index | (FiO2 * Mean Airway Pressure * 100) / PaO2 | | OSI | Oxygen Saturation Index | (FiO2 * Mean Airway Pressure * 100) / SpO2 |

The T3 Software is intended for the recording and display of multiple physiological parameters of adult, pediatric and neonatal patients from supported bedside devices. T3 is not intended for alarm notification or waveform display, nor is it intended to control any of the independent bedside devices to which it is connected. T3 is intended to be used by healthcare professionals for the following purposes: - To remotely consult regarding a patient's status, and - To remotely review other standard or critical near real-time patient data in order to aid in clinical decisions and deliver patient care in a timely manner. T3 can display numeric physiologic data captured by other medical devices: - Airway flow, volume and pressure - Arterial blood pressure (invasive and non-invasive, systolic, diastolic, and mean) - Bispectral index (BIS, signal quality index, suppression ratio) - Cardiac Index - Cardiac output - Central venous pressure - Cerebral perfusion pressure - End-tidal CO2 - Heart rate - Heart rate variability - Intracranial pressure - Left atrium pressure - Oxygen saturation (intravascular, regional, SpO2) - Premature ventricular counted beats - Pulmonary artery pressure (systolic, diastolic, and mean) - Pulse pressure variation - Pulse Rate - Respiratory rate - Right atrium pressure - Temperature (rectal, esophageal, tympanic, blood, core, nasopharyngeal, skin) - Umbilical arterial pressure (systolic, diastolic, and mean) It can also display laboratory measurements including arterial and venous blood count, and lactic acid. T3 includes a Patient Risk Analytics Engine that calculates an index (the Inadequate Oxygen Delivery Index) that is indicated for use by health care professionals with post-surgical neonatal patients weighing 2 kg or more under intensive care. The Inadequate Oxygen Delivery Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by T3. When the index is elevated, it means that there is increased risk of inadequate oxygen delivery and attention should be brought to the index presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements. WARNING: T3 Software is not an active patient monitoring system. It is intended to supplement and not replace any part of the hospital's device monitoring. Do not rely on the T3 Software Solution as the sole source of patient status information.

The Tracking, Trajectory, Trigger (T3) intensive care unit software solution allows clinicians and quality improvement teams in the ICU to aggregate data from multiple sources, store it in a database for analysis, and view the streaming data in real-time. System features include: - Customizable display of physiologic parameters over entire patient stay. - Configurable annotation - Web-based visualization that may be used on any standard browser - Minimal IT footprint - Software-only solution no new bedside hardware required - Highly reliable and robust operation. - Auditable data storage. The subject device is a modification of the T3 Software that includes Risk Analytics Engine that computes an Inadequate Oxygen Delivery Index (IDO2). The IDO2 Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by T3. This index provides an interpretation of how different the patient's physiologic measures are from normality.

The T3 Software is intended for the recording and display of multiple physiological parameters of adult, pediatric and neonatal patients from supported bedside devices. T3 is not intended for alarm notification or waveform display, nor is it intended to control any of the independent bedside devices to which it is connected. T3 is intended to be used by healthcare professionals for the following purposes: - · To remotely consult regarding a patient's status, and - · To remotely review other standard or critical near real-time patient data in order to aid in clinical decisions and deliver patient care in a timely manner. T3 can display numeric physiologic data captured by other medical devices: - · Airway flow, volume and pressure - · Arterial blood pressure (invasive and non-invasive, systolic, diastolic, and mean) - · Bispectral index (BIS, signal quality index, suppression ratio) - Cardiac Index - Cardiac output - Central venous pressure - · Cerebral perfusion pressure - · End-tidal CO2 - · Heart rate - · Heart rate variability - · Intracranial pressure - · Left atrium pressure - · Oxygen saturation (intravascular, regional, SpO2) - · Premature ventricular counted beats - · Pulmonary artery pressure (systolic, diastolic, and mean) - · Pulse pressure variation - Pulse Rate - · Respiratory rate - · Right atrium pressure - · Temperature (rectal, esophageal, tympanic, blood, core, nasopharyngeal, skin) - · Umbilical arterial pressure (systolic, diastolic, and mean) It can also display laboratory measurements including arterial and venous blood count, and lactic acid. WARNING: T3 Software is not an active patient monitoring system. It is intended to supplement and not replace any part of the hospital's device monitoring. Do not rely on the T3 Software Solution as the sole source of patient status information.

The Tracking, Trajectory, Trigger (73) intensive care unit software solution allows clinicians and quality improvement teams in the ICU to aggregate data from multiple sources, store it in a database for analysis, and view the streaming data in real-time. System features include: - Customizable display of physiologic parameters over entire patient stay ● - Configurable annotation . - Web-based visualization that may be used on any standard browser ● - . Minimal IT footprint - Software-only solution no new bedside hardware required . - Highly reliable and robust operation - Auditable data storage . The T3 Software is intended for the display and recording of multiple physiological parameters of adult, pediatric and neonatal patients. T3 is not intended for alarm notification, nor is it intended to control any of the independent bedside devices to which it is connected The T3 software can display user-defined, derived measures. These measures include the percentage of time within a time period that a particular variable is above or below a threshold. The user can configure the time period, threshold, and label of the resulting derived measure for ease of use considerations, only. The T3 Software is not an active patient monitoring system. It is intended to supplement and not replace any part of the hospital's device monitoring. T3 has a web architecture consisting of a user interface that runs in a browser, and a central web server. The T3 server, a set of cooperating web services written in Java, processes data as it is received, caches it in memory, and writes out copies of the data to a relational database and to the file system. In this manner, the data is available to the user interface to be visualized by the end user - a clinician. Clinicians access the T3 user interface in a web browser. T3 runs in current browsers that support HTML5, Javascript and web sockets, such as Chrome, Firefox, Safari and Internet Explorer. The clinicians may be in the hospital, or may be outside the hospital accessing T3 over a Virtual Private Network (VPN). Clinicians use T3 in addition to the physiometric devices themselves and other information sources such as the electronic medical record to monitor the patient's condition.

The T3 Software is intended for the recording and display of multiple physiological parameters of adult, pediatric and neonatal patients from supported bedside devices. T3 is not intended for alarm notification or waveform display, nor is it intended to control any of the independent bedside devices to which it is connected. T3 is intended to be used by healthcare professionals for the following purposes: - · To remotely consult regarding a patient's status, and - · To remotely review other standard or critical near real-time patient data in order to aid in clinical decisions and deliver patient care in a timely manner. T3 can display numeric physiologic data captured by other medical devices: - · Airway flow, volume and pressure - · Arterial blood pressure (invasive and non-invasive, systolic, diastolic, and mean) - · Bispectral index (BIS, signal quality index, suppression ratio) - Cardiac Index - · Cardiac output - · Central venous pressure - · Cerebral perfusion pressure - · End-tidal CO2 - · Heart rate - · Heart rate variability - · Intracranial pressure - · Left atrium pressure - · Oxygen saturation (intravascular, regional, SpO2) - · Premature ventricular counted beats - · Pulmonary artery pressure (systolic, diastolic, and mean) - · Pulse pressure variation - · Pulse Rate - · Respiratory rate - · Right atrium pressure - · Temperature (rectal, esophageal, tympanic, blood, core, nasopharyngeal, skin) - · Umbilical arterial pressure (systolic, diastolic, and mean) WARNING: T3 Software is not an active patient monitoring system; it is intended to supplement and not replace any part of the hospital's device monitoring. Do not rely on the T3 Software as the sole source of patient status information.

The Tracking, Trajectory, Trigger (73) intensive care unit software solution allows clinicians and quality improvement teams in the ICU to aggregate data from multiple sources, store it in a database for analysis, and view the streaming data in real-time. System features include: - Customizable display of physiologic parameters over entire patient stay ● - Configurable annotation ● - Web-based visualization that may be used on any standard browser ● - Minimal IT footprint ● - Software-only solution no new bedside hardware required ● - Highly reliable and robust operation ● - Auditable data storage ● The T3 Software is intended for the display and recording of multiple physiological parameters of adult, pediatric and neonatal patients. T3 is not intended for alarm notification or waveform display, nor is it intended to control any of the independent bedside devices to which it is connected. The T3 software can display user-defined, derived measures. These measures include the percentage of time within a time period that a particular variable is above or below a threshold. The user can configure the time period, threshold, and label of the resulting derived measure for ease of use considerations, only. The T3 Software is not an active patient monitoring system. It is intended to supplement and not replace any part of the hospital's device monitoring. T3 has a web architecture consisting of a user interface that runs in a browser, and a central web server. The T3 server, a set of cooperating web services written in Java, processes data as it is received, caches it in memory, and writes out copies of the data to a relational database and to the file system. In this manner, the data is available to the user interface to be visualized by the end user – a clinician. Clinicians access the T3 user interface in a web browser. T3 runs in current browsers that support HTML5, Javascript and web sockets, such as Chrome, Firefox, Safari and Internet Explorer. The clinicians may be in the hospital, or may be outside the hospital accessing T3 over a Virtual Private Network (VPN). Clinicians use T3 in addition to the physiometric devices themselves and other information sources such as the electronic medical record to monitor the patient's condition.