VitalScan ANS. Cardiac Autonomic Function Testing (ANS) VitalScan ANS+ In 15 Minutes Identify Patients at Risk

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1 VitalScan ANS Medeia Inc Cardiac Autonomic Function Testing (ANS) In 15 Minutes Identify Patients at Risk The VitalScan diagnostic test provides next generation non invasive patient diagnostics within minutes. The FDA cleared equipment is used by physicians to help identify diseases that may be associated with Autonomic Nervous System, Autonomic Regulation and Autonomic Function.

2 THE FUTURE OF HEALTH CARE: AUTONOMIC NERVOUS SYSTEM TESTING (ANS) provides comprehensive, fully automated autonomic testing equipment that is useful for physicians to gauge their patient s health and uncover hidden disease. Testing the autonomic nervous system can identify clinical autonomic disorders uncover major illness and other hidden diseases, such as: Sudden Death Silent Heart Attack Hypertension Cardiac Autonomic Neuropathy Vascular Abnormalities Orthostatic Hypotension Syncope PHYSICIAN BENEFITS is a valuable tool in diagnosing hidden illnesses. Having the ability to quickly and easily test patients and receive immediate comprehensive interpretive reports after the test is invaluable to medical practitioners. Testing takes only 15 minutes to run a full battery of tests including cardiovascular assessment. Interpretive reports are generated immediately after testing. The reports are very easy to read and understand and include additional details and graph options for the physician. VitalScan Plus has 39 standardized tests. In addition, provides you with the ability to customize your own tests and create your own templates.

3 WHY TEST? According to Published Studies1 Cardiovascular autonomic neuropathy occurs in about 17% of patients with type 1 diabetes and 22% of those with type 2 Of patients with symptomatic autonomic dysfunction, 25% to 50% die within 1 to 5 years of diagnosis. A patient s history and physical examination are ineffective for early detection of CAN, and therefore noninvasive tests that have demonstrated efficacy are required. Screening for Autonomic Neuropathy should be instituted at Diagnosis of Type 2 Diabetes and 5 years after the diagnosis of type 1 Diabetes 2005 ADA Standard of Diabetes Care Although it can cause severe cardiovascular problems and sudden death, surveys show that only 2% of people with diabetes are tested for cardiovascular autonomic neuropathy (CAN). FEATURES AND BENEFITS Easily adaptable towards general and specific requirements of almost all medical branches. Presents a quick and reliable supplementary assessment of basic health risk factors. Assesses the balance between the activities of the sympathetic and parasympathetic branches of the autonomic nervous system. Reliably discovers ventricular and supraventricular extra systoles. Assesses accumulated physical and mental stress. Assesses physical training needs based upon an individual's personal fitness levels. Reveals development of possible health risks. Provides early indications of health risks for quick detection and prevention of illness, disease, and progressive stress conditions before onset and development. Efficiently screen mass population to detect potential risks and reserve costly, full medical checkups for only those exhibiting health threats.

4 What is Autonomic Nervous System (ANS) The autonomic nervous system (ANS) regulates physiologic processes, such as blood pressure, heart rate, body temperature, digestion, metabolism, fluid and electrolyte balance, sweating, urination, defecation, sexual response, and other processes. Regulation occurs without conscious control, i.e., autonomously. The ANS has two major divisions: the sympathetic and parasympathetic systems. Many organs are controlled primarily by either the sympathetic or parasympathetic system, although they may receive input from both; occasionally, functions are reciprocal (e.g., sympathetic input increases heart rate; parasympathetic decreases it). The sympathetic nervous system is catabolic and activates fight or flight responses. Thus, sympathetic output increases heart rate and contractility, bronchodilation, hepatic glycogenolysis and glucose release, BMR (basal metabolism rate), and muscular strength; it also causes sweaty palms. Less immediately life preserving functions (e.g., digestion, renal filtration) are decreased. The parasympathetic nervous system is anabolic; it conserves and restores. Gastrointestinal secretions and motility (including evacuation) are stimulated, heart rate is slowed, and blood pressure decreases. Disorders of the ANS can affect any system of the body; they can originate in the peripheral or central nervous system and may be primary or secondary to other disorders. Symptoms suggesting autonomic dysfunction include orthostatic hypotension, heat intolerance, nausea, constipation, urinary retention or incontinence, nocturia, impotence, and dry mucous membranes. If a patient has symptoms suggesting autonomic dysfunction, cardiovagal, adrenergic, and sudomotor tests are usually done to help determine severity and distribution of the dysfunction. Autonomic Regulation is the body s ability to maintain homeostasis (stability and balance) during internal and external stimuli. Autonomic Regulation is always functioning, and we are often unaware of the important tasks it is performing. When the nerves that control Autonomic Regulation are damaged, Autonomic Dysfunction can develop. Autonomic Dysfunction can be temporary or chronic. Diabetes and Parkinson s disease are two examples of chronic conditions that can lead to Autonomic Dysfunction. tests Autonomic Regulation through a combination of Heart Rate Variability (HRV) Assessment and Cardiac Autonomic Reflex Tests (CARTs). Cardiovagal innervation testing evaluates heart rate response to deep breathing and to the Valsalva maneuver, via electrocardiogram rhythm strip. If the ANS is intact, heart rate varies with these maneuvers; the ratio of longest to shortest R R interval (Valsalva ratio) should be 1.4 or greater. Vasomotor adrenergic innervation testing evaluates response of beat to beat blood pressure to the head up tilt and Valsalva maneuver. The head up tilt shifts blood to dependent parts, causing reflex responses. The Valsalva maneuver increases intrathoracic pressure and reduces venous return, causing blood pressure changes and reflex vasoconstriction. In both tests, the pattern of responses is an index of adrenergic function.

5 VitalScan ANS Significant Clinical Applications Medeia Inc VitalScan is diagnostic tool to evaluate symptoms of vasomotor instability for any of the following: Diagnose the presence of autonomic neuropathy in a patient with signs or symptoms suggesting a progressive autonomic neuropathy, including: Diabetic neuropathy, Amyloid neuropathy, Sjogren s syndrome, Idiopathic neuropathy, Pure autonomic failure, Multiple system dystrophy. Evaluate the severity and distribution of a diagnosed progressive autonomic neuropathy; Differentiate the diagnosis between certain variants of syncope from other causes of loss of consciousness; Evaluate inadequate response to beta blockade in vasodepressor syncope; Differentiate the cause of postural tachycardia syndrome; Evaluate change in type, distribution or severity of autonomic deficits in patients with autonomic failure; Evaluate the response to treatment in patients with autonomic failure; Diagnose axonal neuropathy or suspected autonomic neuropathy in the symptomatic patient; Evaluate and diagnose sympathetically maintained pain, as in reflex sympathetic dystrophy or causalgia; or Evaluate and treat patients with recurrent unexplained syncope to demonstrate autonomic failure. VitalScan assessments provide supplemental monitoring and optimized detection of cardiovascular, neurological and metabolic conditions associated with a multitude of adverse health events. The VitalScan product range provide physicians and health professionals with convenient, cost effective solutions for clinical testing and optimized patient assessment. Applications include the following: Beta Blocker Responsiveness Cardiovascular Autonomic Neuropathy (CAN) Diabetic Autonomic Neuropathy (DAN) Cardiomyopathies Cardiac Arrhythmias Congestive Heart Failure Syncope Hypertension Sleep Apnea Asthma Sudden Death COPD Peripheral Vascular Diseases Orthostatic Hypotension Circulation Problems Pain Management Neurological Conditions Chronic Regional Pain Syndrome Anxiety/Stress Parkinson's Disease Psychological Conditions Other Hidden Diseases

6 Cardiac Autonomic Testing Benefits Cardiac Autonomic Testing measures neuro cardiac function which reflects heart brain interactions and autonomic nervous system dynamics. The autonomic nervous system is involved in the function of virtually every organ system and clinical manifestations of autonomic dysfunction are involved in just about every disease. As a result, ANS analysis is used as a screening and monitoring tool in many disease processes. VitalScan ANS delivers laboratory analyses to the physician's office, enabling professionals to assess patient health conveniently and reliably. Applications include: Verifying the effectiveness of treatment and intervention Monitoring overall patient health Screening the general population Identifying various health issues such as heart palpitations, pain management, sleep apnea, anxiety, stress, psychological disorders, asthma, and neurological conditions Examining for CAN (Cardiac Autonomic Neuropathy) and DAN (Diabetes Autonomic Neuropathy) Measuring the Sympathetic Nervous System's predominance in cases such as Metabolic Syndrome, Hypertension or Heart Failure Screening for unfavorable in the absence of clinically apparent health situations Autonomic Function Assessment has acquired exceptional popularity over the last few years. Nowadays, the main stream medical associations around the world accept ANS studies as one of the best predictors of specific and non specific health risk. Scientific and Clinical studies have established its usefulness in almost all branches of medicine.

7 How It Helps Your Patients: Evaluation of current health situation symptoms, medications and therapy reactions; Assessment of possible adequacy of the recovery process; Initiation of Physician s focus to treat the onset of chronic situations or severity of the diseases; Evaluation of the prognosis and treatment outcomes; Identification of abnormalities in cardiovascular, cerebrovascular system and overall health assessment; Blood circulatory status age of blood vessels based on arterial elasticity, peripheral circulatory status, organic/functional abnormality of the blood vessels; Prediction and progression of Arteriosclerosis, Obesity, Hypertension, Hyperlipidemia and Diabetes; Useful as a health barometer; How It Helps You: Monitoring current health of the individual patient closely; Verifying the efficacy of current treatment protocol and intervention; Examining patients for CAN and DAN Cardiac Autonomic Neuropathy and Diabetes Autonomic Neuropathy; Measuring the Metabolic Syndrome, Hypertension, Heart Failure; Predicting burn out syndrome, anxiety, depression, psychological conditions; Exploring Asthma, COPD, Palpitations, Pain management, Sleep apnea PLUS; Optimization of treatment for each individual patient; Immediate reports qualitative, quantitative and graphic analysis and results of ANS balance, cardiovascular, stress, fitness and overall health assessment for comparison with patient case history and necessary procedural actions; Efficient patient centered multiple symptoms treatment management;

8 HOW IS THE TEST PERFORMED? Have you recently been informed by that your hospital or clinic should begin administering ANS tests? Are you aware of healthcare guidelines that will require a care path for your patients? If so, it is very likely you have many questions or reservations regarding a new procedure that you are unfamiliar with. However, don t let simple confusion or misunderstanding inhibit you from doing what is best for the health of your patients. The ANS, or Autonomic Nervous System, test is designed to best evaluate your patient s bodily functions and plays a significant role in investigating those who suffer from various diseases. There are no invasive or potentially harmful procedures involved, and often a single exam lasts less than a half hour and can be performed by an MA. The comprehensive report is also interpreted. The test involves four separate procedures, each of which is designed to determine a particular aspect of your patient s ANS. The four portions are: Resting Phase: Heart Rate Variability combined with beat to beat blood pressure is measured to obtain a baseline of how the autonomic system is functioning during the resting phase. Deep (Metronomic) Breathing Test: Heart Rate Variability combined with beat to beat blood pressure is measured and monitored during Deep Breathing. Additional comparisons are made to determine the changes during Deep Breathing from the baseline. Valsalva Test: Heart Rate Variability combined with beat to beat blood pressure is measured during Valsalva Maneuver. Additional monitoring and comparisons are obtained to determine the change from the baseline in comparison with the Valsalva maneuver. Standing or Tilt: Heart Rate Variability coupled with beat to beat blood pressure is monitored and measured during Standing/Tilt, and changes are compared with the baseline. The data obtained from the ANS test evaluates the Parasympathetic (rest and digest) and the Sympathetic (fight, flight response) system to make sure the entire ANS is in balance. Obtaining objective data on the parasympathetic and sympathetic component of the ANS can pinpoint health risks such as sudden death, silent heart attacks, syncope, hypertension and other hidden diseases; likewise, beat to beat blood pressure under various conditions can be used to test adrenergic functions for conditions like orthostatic hypotension (OH). OH is widely known to be a consequence of chronic diabetes frequently found amongst the elderly population. Since many OH symptoms can be difficult to trace impaired concentration, fatigue, etc. ANS testing can fill this void and bring these problems to light sooner. If you are still uncertain as to whether ANS testing should be an intricate part of patient care, take the time to consider the investment versus potential reward. Many victims of diabetes and other debilitating diseases have sought out hospitals renowned for their examination of the autonomic nervous system. Your patients depend on you to provide them with the best possible health care. Recent developments in healthcare require you to provide patient education as well as the care path for improving patient health; the ANS test helps you to do both. The amount of information that a single ANS test can provide in just 12 minutes may very well save the life of an ill, elderly or seemingly healthy person. The use of technology now offers a fast, simple and effective way to test patients for multiple illnesses and allows you to provide improved patient care and maximize the use of your professional time with each patient.

9 CUMULATIVE STRESS AND HEALTH RESERVE ASSESSMENT ANS Dysregulation 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 Dysregulation can be caused by factors such as insecurity, negative emotions, mental overload, confusion, rejection on a social level, family problems, boredom, low self esteem, 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.

10 CARDIOVASCULAR ORTHOSTATIC 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 or tilt 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. VitalScan ANS 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.

11 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.

12 OVERALL HEALTH ASSESSMENT Establishing overall health level is key to disease prevention and optimized health. VitalScan ANS presents a systematic and convenient approach to calculating individual overall health. By combining the results of all VitalScan ANS 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. VitalScan ANS analyzes the potential for health problems by examining the body of data generated by thorough testing as compared to a database of over 250,000 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 life threatening 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. VitalScan ANS 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 VitalScan ANS analyses and health testing cannot be overstated as preventative tools and supplementary guides to overall patient health.

13 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.

14 COMPREHENSIVE NON INVASIVE SYSTEM INCLUDES: Comprehensive Autonomic Balance Analysis (ANS) Arterial Vascular Assessment 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 VitalScan Medeia Inc