T3 Platform software

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 utilize this information 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.

WARNINGS:

• Do not use the T3 Platform software as an active patient monitoring system.

• Do not use the T3 Platform software to replace any part of the hospital's device monitoring.

• Do not rely on the T3 Platform software as the sole source of patient status information.

• Do not use any of the T3 Platform indices as a substitute for taking blood samples.

• The indices present qualitative and potentially imperfect information of the patient's condition and in certain scenarios, the indices may contradict each other. The primary data should be reviewed as part of standard patient evaluations and no decisions should be solely based on the indices.