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The AHI System is intended for use by healthcare professionals managing patients 18 years or older who are receiving continuous physiological monitoring with electrocardiography (ECG) in hospitals. AHI provides a frequently updated binary output over time based on pattern analysis of a lead-II ECG waveform intended to describe a patient's hemodynamic status and indicate if a patient is showing signs of hemodynamic stability or instability. Signs of hemodynamic instability (HI) are defined as hypotension (systolic blood pressure <90 mmHg or mean arterial pressure (MAP) <70 mmHq) combined with tachycardia (heart rate ≥ 100 bpm). AHI-PI provides the clinician with physiological insight into a patient's likelihood of a future episode of HI. An episode of HI is defined as 10 continuous minutes or more where HI is present. The goal of this adjunctive monitoring method is to enable identification of patients who are showing HI or are likely to experience a future episode of HI, and to allow clinicians an opportunity to increase vigilance. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.

The AHI System is a multiparameter system designed to meet clinicians' need to identify patient hemodynamic status and predict patient hemodynamic instability episodes using two analytics:1. Analytic for Hemodynamic Instability (AHI): Utilizing data from a single existing lead of a non-invasive electrocardiograph (ECG), AH analyzes heart rate variability (HRV) and ECG morphology features to rapidly detect signs of hemodynamic stability and categorize each window of data as either "AHI Stable" or "AHI Unstable." Time trending of AHI outputs is also provided. 2. Analytic for Hemodynamic Instability Predictive Indicator (AH-P); Utilizing AH outputs from up to the most recent 30 minutes of EG data, AH-PI indicates the likelihood of a future episode of hemodynamic instability, defined as ten continuous minutes or more where signs of hemodynamic instability are present.

The AHI System is intended for use by healthcare professionals managing patients 18 years or older who are receiving continuous physiological monitoring with electrocardiography (ECG) in hospitals. AHI provides a frequently updated binary output over time based on pattern analysis of a lead-II ECG waveform intended to describe a patient's hemodynamic status and indicate if a patient is showing signs of hemodynamic stability or instability. Signs of hemodynamic instability (HI) are defined as hypotension (systolic blood pressure <90 mmHg or mean arterial pressure (MAP) <70 mmHg) combined with tachycardia (heart rate ≥ 100 bpm). AHI-PI provides the clinician with physiological insight into a patient's likelihood of a future episode of HI. An episode of HI is defined as 10 continuous minutes or more where HI is present. The goal of this adjunctive monitoring method is to enable identification of patients who are likely to experience a future episode of HI, and to allow clinicians an opportunity to increase vigilance. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.

The AHI System is a multiparameter system designed to meet clinicians' need to identify patient hemodynamic status and predict patient hemodynamic instability episodes using two analytics: 1. Analytic for Hemodynamic Instability (AHI) (as granted in DEN200022): Utilizing data from a single existing lead of a non-invasive electrocardiograph (ECG), AHI analyzes heart rate variability (HRV) and ECG morphology features to rapidly detect signs of hemodynamic stability or instability and categorize each window of data as either "AHI Stable" or "AHI Unstable." Time trending of AHI outputs is also provided. 2. Analytic for Hemodynamic Instability Predictive Indicator (AHI-PI): Utilizing AHI outputs from up to the most recent 30 minutes of ECG data, AHI-PI indicates the likelihood of a future episode of hemodynamic instability, defined as ten continuous minutes or more where signs of hemodynamic instability are present.

The Analytic for Hemodynamic Instability (AHI) software is intended for use by healthcare professionals managing in-hospital patients 18 years or older who are receiving continuous physiological monitoring with electrocardiography (ECG). AHI provides a frequently undated binary output over time based on pattern analysis of a lead-II ECG waveform intended to describe a patient's hemodynamic status and indicate if a patient is showing signs of hemodynamic stability or instability. Signs of hemodynamic instability are defined as hypotension (systolic blood pressure <90 mmHg or mean arterial pressure (MAP) <70 mmHg) combined with tachycardia (heart rate ≥ 100 bpm). The goal of this adjunctive monitoring method is to enable identification of patients who are showing signs of hemodynamic instability and to allow clinicians an opportunity to increase vigilance. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.

Analytic for Hemodynamic Instability (AHI) is a software as a medical device (SaMD) that analyzes Lead-II ECG signals to identify patients who are showing signs of hemodynamic instability. Signs of hemodynamic instability are defined as low blood pressure (BP) and high heart rate (HR). The device processes 5 minutes of continuously recorded Lead II ECG data to determine the presence of a combination of HR ≥ 100 bpm and SBP < 90 mmHg/MAP < 70 mmHg within a 2-minute sliding window as shown in the figure below. The system normalizes input signals and assesses signal quality prior to data analysis.