Search Results

The Etiometry Platform™ software features the Data Aggregation software module version 5.4 and the Risk Analytics Engine software module version 9.2. The Data Aggregation & Visualization software module is intended to record and display multiple physiological parameters of adult, pediatric, and neonatal patients from supported bedside devices. The software module is not intended for alarm notification, 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 Data Aggregation & Visualization software module can display numeric physiologic data and waveforms 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) Electrocardiogram Plethysmograph The Data Aggregation & Visualization software module can display laboratory measurements including arterial and venous blood gases, complete blood count, and lactic acid. The Data Aggregation & Visualization software module can display information captured by the Risk Analytics Engine software module. The 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 and patients 18 years of age or older under intensive care and not on Mechanical Circulatory Support. The IDO2 Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the 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 healthcare 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 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 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 Data Aggregation 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 Etiometry Platform allows ICU clinicians and quality improvement teams to aggregate data from multiple sources, store it in a database for analysis, and view the streaming data. The platform 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 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 CipherOx™ CRI MI is indicated for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (measured by an SpO2 sensor),and the Compensatory Reserve Index (CRI), which trends changes in intravascular volume relative to the individual patient's response to hypovolemia. For patients with a finger thickness of 0.3'' to 1'' in hospital and pre-hospital settings. CRI trends with changes in intravascular volume relative to the individual patient's response to hypovolemia, and should only be used by qualified medical providers as an adjunct to rather than as a replacement for traditional hemodynamic measures. CRI is indicated for adults (19-36 years old) in the supine position under non-motion conditions and without cardiovascular disease. CRI has not been studied in trauma patients.

The CipherOx CRI™ M1 is a modification of the predicate device, the CipherOx CRI Tablet (DEN160020). The M1 is a smaller version of the Tablet that is designed for increased portability. The CipherOx CRITM M1 is a non-invasive, continuous, and multi-parameter monitor that displays SpO2, HR, and the Compensatory Reserve Index (CRI). CRITM is a physiologic parameter that trends changes in intravascular volume, which help to assess a patient's hemodynamic status. The CRI™ algorithm trends intravascular volume using non-invasive arterial pulsatile waveform signals by continuously comparing extracted waveforms to a reference model. CipherOx™ CRI system operates on the photoplethysmograph (PPG) waveform used in pulse oximetry to estimate CRI. The CipherOx CRI™ M1 incorporates: - 1. CRI™ algorithm - Nonin pulse ox sensor (8000AA K080255) 2. - 3. M1 User Interface module which is a small, portable, battery powered unit that displays heart rate. SpO2, and CRI™.

The CipherOx CRI Tablet is indicated for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (measured by an SpO2 sensor), and the Compensatory Reserve Index (CRI), which trends changes in intravascular volume relative to the individual patient's response to hypovolemia. For patients with a finger thickness of 0.3" to 1" in hospital and pre-hospital settings. CRI trends with changes in intravascular volume relative to the individual patient's response to hypovolemia, and should only be used by qualified medical providers as an adjunct to rather than as a replacement for traditional hemodynamic measures. CRI is indicated for adults (19-36 years old) in the supine position under non-motion conditions and without cardiovascular disease. CRI has not been studied in trauma patients.

The CipherOx CRI Tablet consists of a Nonin Onyx II Model 9560 finger pulse oximeter (previously cleared under K081285) that communicates by Bluetooth with a Cybernet CyberMed T10 tablet PC. The CipherOx CRI Tablet is a continuous, multi-parameter monitor that displays SpO2, Heart Rate (HR), photoplethysmograph (PPG) waveform images, and the Compensatory Reserve Index (CRI) value and historical trend-line. CRI is an index related to the physiologic changes induced by intravascular fluid loss and ranges from 0 to 1, where 1 indicates a normal subject and 0 indicates a subject who has undergone significant physiological effects from loss of fluid volume.