Comprehensive Non Invasive System Includes: Autonomic Balance Analysis Cardiovascular Pulse Wave Velocity Analysis ECG Analysis Cardiovascular Fitness Analysis Metabolic Report Arterial Vascular Assessment Peripheral Arterial Tone QANS Assessment System include QANS QHRV Device Laptop Proprietary Software 3 Lead ECG Pulse wave SpO2 Finger Probe Printer QANS ASSESSMENT SYSTEM A CLINICAL POWERFUL EASY TO USE NON INVASIVE SYSTEM In 15 Minutes Identify Patients at Risk for Sudden Death, Silent Heart Attack, Hypertension Cardiac Autonomic Neuropathy, Diabetic Autonomic Neuropathy, Vascular Abnormalities, Orthostatic Hypotension, Syncope and other Hidden Diseases Testing of the Autonomic Nervous System is a Recommended Standard of Care by the American Diabetes Association for patients with Type 1 and Type 2 diabetes Testing of Arterial Circulation and the Autonomic Nervous System accepted by most private and public insurance. FDA 510K Cleared Finally, the new break through technology you have been waiting for. 9
AUTONOMIC NERVOUS SYSTEM (ANS) AND AUTONOMIC BALANCE ASSESSMENT Heart Rate Variability (HRV) is a physiological function whereby the time interval between heart beats varies. These variations in heart rate reflect the quality of cardiovascular autonomic function. Autonomic function or function of the autonomic/visceral nervous system regulates involuntary action (eg. respiration, digestion) of the intestines, heart, smooth muscle, and glands. This function is divided into two physiologically and anatomically distinct, mutually antagonistic subsystems: the sympathetic nervous system and the parasympathetic nervous system. QHRV systems provide HRV testing which enable physicians to monitor the activity of both the sympathetic and parasympathetic branches of the autonomic nervous system (ANS) in order to accurately assess the state of a patient's autonomic function. QHRV provides a two pronged approach to patient evaluation. Firstly, QHRV is able to detect specific types of autonomic dysfunction which can consequently be linked to a multitude of clinical diagnoses. Secondly, QHRV can be utilized for thorough, comprehensive assessments and physiological monitoring which provide physicians with a detailed and thorough patient appraisal which can often be overlooked in standard evaluations. The wide range of clinical applications for QHRV makes it principally different from all other classes of diagnostic devices. QHRV allows the physician to thoroughly investigate modalities: * Assessment of resting autonomic balance * Assessment of reaction of the ANS on orthostatic intervention * Assessment of autonomic reaction during Valsalva maneuver and deep breathing * Sympathetic and Parasympathetic autonomic balance correction 10
PULSE WAVE VELOCITY (PWV) AND CARDIOVASCULAR ASSESSMENT Pulse wave is a physiological phenomenon, observable and measurable in the arterial system during blood circulation. During one heart systole a certain blood volume is expelled. This propagates through the arteries due to the reciprocal transformation between kinetic energy of a segment of the expelled blood volume and the potential energy of a stretched segment of the resilient vascular wall. We can observe the changes in pressure, blood flow, velocity and profile throughout the whole pulse wave. It can be used for classification of the artery elasticity. The condition of the small and large arteries is key to prevention and diagnosis of cardio vascular related illness. In particular, the stiffness and augmentation of the major arteries is a strong indication of potential health problems including heart attacks, heart failure, sclerosis, and renal complications. PWV Analysis and arterial stiffness indexes (EEI, DDI and DEI) can suggest to healthcare professional to begin appropriate treatment long before the symptoms or clinical signs appear. Age and systolic pressure strongly correlate with PWV. In fact, the most important factor contributing to increase in PWV is age because of increased arterial stiffness caused by medial calcification and loss of elasticity. The measurement of pulse wave velocity is useful in the study of the effects of aging, vascular diseases, vasodilating and vaso constricting agents on arteries. QHRV Pulse Wave Velocity measurement is a convenient method of quantifying arterial stiffness and augmentation. PWV provides invaluable insight into cardiovascular health, management of disease progression and monitoring the effects of medication, treatments, lifestyle and dietary habits. 11
SEGMENTAL VASCULAR ASSESSMENT, ANKLE BRACHIAL INDEX (ABI) AND TOE BRACHIAL INDEX (TBI) Initial assessment is the most vital step in managing a patient s health. As such, extracting as much information and achieving a broad road map of the arterial anatomy is crucial for proper arterial and vascular assessment. QHRV Arterial Vascular Assessment measures blood pressure uses the identical standard as conventional arm cuffs. While the traditional arm cuff method just measures blood pressure, the QHRV Arterial Vascular Assessment is a powerful measure which provides further insight into arterial stiffness. The information collected during the QHRV Arterial Vascular Assessment using the upper arm cuff is disseminated into a wide range of measurements. This data is then extrapolated into a number of indexes and further classifications which include the following: Arterial Stiffness Index (ASI), Blood Pressure (Brachial, Ankle), Pulse Pressure, Pulse Rate, Classification of Cardiovascular Condition The information deduced from the QHRV Arterial Vascular Assessment is invaluable for detecting risk factors and facilitating the identification of patients who may be at risk for cardiovascular events. Studies have shown that the Arterial Stiffness Index (ASI) illustrates a strong correlation between the functioning and integrity of coronary arteries and atherosclerotic lesions. This particular connection is significant in that atherosclerotic lesions are fatal yet may remain asymptomatic for decades. Over 60 million Americans carry these life threatening issues so isolating high risk individuals is most valuable. The indexes generated by the QHRV Arterial Vascular Assessment are far reaching and provide important patient insight into a number of existing and potential health risks. These cardiovascular issues include the following: Atherosclerosis, Infectious vasculitis, Congenital abnormalities, Hypertension, Hyperlipoproteinemia 12
PERIPHERAL ARTERIAL TONE (PAT) PAT (Peripheral Arterial Tone) technology measures arterial tone changes in peripheral arterial beds. This information collected gives specialists important insight into the autonomic nervous system as well as the cardiovascular system. PAT technology is a noninvasive measure that is currently used to detect heart disease, erectile dysfunction and obstructive sleep apnea, however, it has also proven highly effective in the detection and monitoring of other cardiovascular conditions. As PAT data imparts early stage information, PAT technology is highly valuable in disease detection and follow up, thereby improving patient treatment and healthcare costs. In addition to detecting cardiovascular disease, the PAT system also presents potential for improving the diagnosis and management of other medical conditions including metabolic syndrome, diabetes, peripheral arterial disease and many others. 13
CORONARY ARTERY RESPIRATORY ASSESSMENT (CRA) Coronary artery disease (CAD) occurs when the blood vessels that transport blood to the heart are narrowed and hardened due to plaque buildup (atherosclerosis). This narrowing compromises the flow of nutrient rich, oxygenated blood to vital organs which can lead to stroke, heart attack and death. In fact, coronary artery disease is the leading cause of death among American adults. As such, detection are treatment are at the forefront of relevance. The photoplethysmograph (PPG) waveform has profound prognostic value for coronary artery disease. Studies show that fluctuations measured in photoplethysmograph (PPG) amplitude are directly related to coronary artery disease (CAD) and present powerful predictions of risk. Photoplethysmograph (PPG) is measured using a non invasive, radiation free platform. This proprietary test system was developed by QHRV and utilizes a biosensor finger probe to collect data. The patient is then asked to perform a series of controlled breathing exercises. The coronary respiratory response (CRR) is derived from spectral analysis of the PPG signal during instructed breathing. The PPG signal is automatically extracted and captured for processing. Using algorithms and analyzing software, a reading is produced which offers a timely and accurate diagnosis of Significant Coronary Artery Disease (S CAD) 14
CUMULATIVE STRESS AND HEALTH RESERVE ASSESSMENT Stress means different things to different people. People recognize stress as a state of having too much expected of them, of being under pressure or strain, or of being barely able to cope with some external demand which is both excessive and prolonged. All of the symptoms carry the connotation of unreasonable demands being placed on the individual in an emotional, mental or psychological sense. A similar concept underlies the term stress in the medical sciences; a force exerted on a subject that, if not resisted, will damage or destroy it. Stressors can be physical, mental or both. Physical stress is caused by long term exposure to negative factors such as an irregular lifestyle, physical overload, environmental toxicity, cigarette/alcohol/drug use, improper diets, etc. Mental stress can be caused by factors such as insecurity, negative emotions, mental overload, confusion, rejection on a social level, family problems, boredom, low selfesteem, etc. Physical and mental stress each elicits physiological responses that are mediated through the autonomic nervous system. This autonomic nervous system (ANS) is both our major defense against stress and the system that demonstrates the principal symptomatic manifestation of stress in its early stages. The autonomic nervous system is conventionally divided into two parts in a yin/yang balance: the sympathetic, which activates organs, getting them ready to cope with exercise or other physical stress; and the parasympathetic, which controls background "housekeeping" functions in the body. The balance between these two systems is an indicator of the body's reaction to external and internal demands. 15
CARDIOVASCULAR VITALITY TEST It is widely recognized that Orthostatic testing is one of the most effective methods of measuring subtle changes in cardiovascular function, particularly the system's regulatory mechanisms. When performing the Orthostatic test, the patient sits down for several minutes resting peacefully and then stands up. When the body position shifts from supine or seated to standing, specific changes in heart rate and blood pressure occur as a compensatory reaction of the body. Testing helps to assess the ability of both sympathetic and parasympathetic nervous systems to adequately respond to regulatory challenge caused by gravitational shift in the body's blood mass. The test result (i.e. the orthostatic heart rate) is the difference between the heart rates at supine rest and at standing position. For a healthy individual, standing up as well as maintaining the standing posture for several minutes causes no significant physical exertion. However, if there is subtle cardiovascular deficiency or the functional capacity of the body's regulatory mechanisms is inadequate then this maneuver becomes a significant stressor to the body. QHRV Orthostatic testing is the quantitative and qualitative assessment of the fitness and health levels based on HRV analysis. The test is quick and effective and begins with the attachment of simple, noninvasive electrodes, attached as instructed. The candidate is instructed to stand for two minutes followed by sitting for 30 seconds followed by standing for 30 seconds. The full process is repeated alternately for three minutes. The data collected from mean cardio tachogram and spectrum is analyzed to produce eventual results in both quantitative and qualitative format. 16
ECG ANALYSIS Electrocardiography (ECG) is an interpretation of the electrical activity of the heart over time as collected from a patient during the procedural test. Modern ECG devices use sophisticated techniques like amplification, filtering, and signal analysis to accurately and conveniently measure, display, and analyze ECG data. ECG is the most important test for interpretation of cardiac rhythm, conduction system abnormalities, and for the detection of myocardial ischemia. Arrhythmic cardiac events, which may be extrasystoles (i.e. cardiac premature heart beats) are early warning signs for serious potential cardiac issues. The relation between supraventricular or ventricular extrasystoles and health risk is important because they can precede myocardial infarction. They are an early warning signal for possible cardiac problems as myocardial ischaemia ( a decreased oxygen supply to cardiac myofibers or different kinds of cardiomyopathy). Cardiomyopath is a disease or disorder of the heart muscle which can result from numerous conditions including congenital defects, acute or chronic infections, coronary artery disease, drugs and toxins, metabolic disorders, connective tissue disorders, or nutritional deficiencies. 17
EXERCISE ECG ASSESSMENT QHRV s Exercise ECG is an all inclusive, PC based electrocardiogram testing system equipped with state ofthe art technology for performing stress tests of the utmost accuracy. This low cost, easy to use system enables users to simultaneously monitor 12 leads onscreen using programmable reports and protocols. Other highlights and benefits of QHRV s Exercise ECG include the following: Utilizes wireless ECG sensors Automatically generates and prints reports Produces bit to bit blood pressure measurements Customizable stress protocols based on personal preference Produces all standard stress protocols Generates ST measurements for modification before, during or following completion of the test A stress test, otherwise known as an exercise electrocardiogram, is a screening tool used to evaluate the effect of exercise on your heart and lungs. Because some heart issues only become apparent during exercise, the test utilizes a treadmill or stationary bicycle to produce results that can be tracked and measured. This noninvasive, diagnostic test measures your heart rate, blood pressure and electrocardiogram (or heart s electrical activity) before, during and after exercise. The level of exertion is increased gradually during the test to ascertain whether or not the heart and lungs are receiving enough oxygen and performing properly. 18
OVERALL HEALTH ASSESSMENT Establishing overall health level is key to disease prevention and optimized health. QHRV presents a systematic and convenient approach to calculating individual overall health. By combining the results of all QHRV procedural tests including the data collected from Pulse Wave Velocity assessment, ECG analysis, Autonomic Nervous System assessment, cumulative stress testing, fitness testing and correlation analysis a value for overall health is determined. QHRV analyzes the potential for health problems by examining the body of data generated by thorough testing as compared to a database of over 50,000 test subjects. The resulting value is measured in a percentage of overall health risk with 50% relating to 'normal'. A value of over 50% is cause for concern and necessitates medical intervention. The value can be useful in understanding current physical state as well as recognizing resource depletion and reserves available for coping with future ailments. Studies indicate that individuals with increased health risk are more prone to develop illness, including lifethreatening disease, within the following few years of assessment. Determining overall health and risk of disease development is, therefore, vitally important to the prevention of serious illness and an important contribution to the wellbeing and longevity of individual life. Patients are able to address their current health issues and manage risks accordingly in order to improve overall health. QHRV products provide the depth and breadth of information required to make informed decisions regarding therapy, treatment and important lifestyle changes. Products are professional medical solutions suitable for mass testing in a cost effective manner. The value of QHRV analyses and health testing cannot be overstated as preventative tools and supplementary guides to overall patient health. 19
HEART RATE VARIABILITY ANALYSIS (HRV) Heart rate variability (HRV) is a measure of variations in the heart rate. It is usually calculated by analyzing the time series of beat to beat intervals from ECG or arterial pressure tracings. Various measures of heart rate variability have been proposed, which can roughly be subdivided into time domain, frequency domain and non linear measures. HRV is regarded as an indicator of the activity of autonomic regulation of circulatory function. It also regarded as the definitive method of analyzing the activity of the autonomic nervous system. Alteration (mostly reduction) of HRV has been reported to be associated with various pathologic conditions like hypertension, hemorrhagic shock, and septic shock. It has found its role as a predictor of mortality after an acute myocardial infarction. Time Domain A simple example of a time domain measure is the calculation of the standard deviation of beat to beat intervals. Other time domain measures include root mean square of the differences between heart beats (rmssd), NN50 or the number of normal to normal complexes that fall within 50 milliseconds, and pnn50 or the percentage of total number beats that fall with 50 milliseconds. SDNN has been strongly corelated to overall variability, while rmssd relates to the parasympathetic nervous system activity on heart rate. Frequency Domain A common frequency domain method is the application of the discrete Fourier transform also known as the Fast Fourier transform, to the beat to beat interval time series. That expresses the amount of variation for different frequencies. Several frequency bands of interest have been defined in humans. 20
COMPREHENSIVE NON INVASIVE SYSTEM INCLUDES: Autonomic Function Balance Analysis (ANS) Arterial Vascular Assessment Segmental Ankle Brachial Index (ABI) Cardiovascular Fitness Cumulative Mental and Physical Stress Pulse Wave Velocity Augmentation Index (AI) Reflection Index (RI) ECG Analysis Stiffness Index (SI) Peripheral Arterial Tone Assessment (PAT) Endothelial Dysfunction SpO2 Coronary Artery Respiratory Assessment (CRA) Ejection Elasticity Index (EEI) Dicrotic Dilation Index (DDI) Dicrotic Elasticity Index (DEI) Overall Health Risk Factor 21
2015 Medeia Company All rights reserved. Medeia Company reserves the right to make changes in specifications and features shown herein, or discontinue the product described at any time without notice or obligation. This does not constitute a representation or warranty or documentation regarding the product or service featured. Not all product or service featured are available in USA. Medeia, QMedical, QANS, QHRV, Dantest, and VitalScan are trademarks of Medeia Company. ABOUT MEDEIA Since its inception in 1992, Medeia has been on the forefront in the manufacture and distribution of Heart Rate Variability, ANS, and Cardiovascular, and Sudomotor products. Medeia specializes in the development of state of the art biometrical software and hardware products intended to monitor physiology for research and educational purposes. We provide a full spectrum of Heart Rate Variability instruments, complimenting both the research and educational spheres, because our expert software and hardware development is focused on the design and implementation of highly innovative, industry leading products designed to meet the needs of researchers, consumers, educational, corporate, fitness and professional services. The company's current products have proven marketability and are valued by practitioners and researchers in a variety of health care and professions throughout the world. Our focus and goal is to continually seek strategic alliances to develop cooperative products and concepts to bring to the market place. U.S.A. 80 S.W. 8th Street, Suite 2000 Miami, FL, 33130, USA Canada 4286 Morgan Cres West Vancouver, BC, Canada, V7V 2N9 22