VitalScan 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.

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.

Autonomic nervous system (ANS) testing, including parasympathetic function (cardiovagal innervation), sympathetic adrenergic function (vasomotor adrenergic innervation).

VitalScan ANS+ 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 complicated variants of syncope from other causes of loss of consciousness;
  • Evaluate inadequate response to beta blockade in vasodepressor syncope;
  • Evaluate distressing symptoms in the patient with a clinical picture suspicious for distal small fiber neuropathy in order to diagnose the condition;
  • 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 who demonstrate a change in clinical exam;
  • 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.

Applications


Higher variations in the heart rate lead to greater heart rate variability which indicates good health and well-balanced autonomic function (sympathetic and parasympathetic nervous systems). In contrast, steadier heart rate leads to lower heart rate variability which indicates an imbalance in the autonomic function and implies the presence of physiological malfunction.

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

Scientific Evidence


Reduction in HRV leads to adverse prognostic implications in cardiovascular, neurological and other metabolic conditions such as diabetes and obesity.

Short term HRV analysis can identify patients at high risk for premature death within cardiac risk stratification.

HRV test procedures provide supplemental monitoring and optimized detection of early signs of adverse effects of any medications.

In general population studies, a deterioration of HRV patterns can be a useful indicator of endangered health situation related to adverse events.

Physical and pharmaceutical interventions to increase HRV lead to better individual prognosis.

Significant Clinical Applications


VitalScan ANS+ assessments provide supplemental monitoring and optimized detection of cardiovascular, neurological and metabolic conditions associated with a multitude of adverse health events. The VitalScan ANS+ 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
  • Ortostatic Hypotension
  • Circulation Problems
  • Pain Management
  • Neurological Conditions
  • Chronic Regional Pain Syndrome
  • Anxiety/Stress
  • Parkinson's Disease
  • Psychological Conditions
  • Other Hidden Diseases



Key Benefits


  • Autonomic Balance Analysis (ANS)
    Autonomic Balance Analysis - ANS 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.

    VitalScan ANS+ 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.

    VitalScan ANS+vides a two-pronged approach to patient evaluation. Firstly, VitalScan ANS+ is able to detect specific types of autonomic dysfunction which can consequently be linked to a multitude of clinical diagnoses. Secondly, VitalScan ANS+ 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 VitalScan ANS+ makes it principally different from all other classes of diagnostic devices. VitalScan ANS+ 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

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  • Cumulative Stress 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 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.

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  • Cardiovascular Fitness Test
    Fitness 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.

    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.
    This module is for research use only.

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  • 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.

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  • Exercise ECG Assessment
    VitalScan ANS+’s Exercise ECG is an all-inclusive, PC-based electrocardiogram testing system equipped with state-of-the-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 VitalScan ANS+’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.

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  • 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+cedural 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 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 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+ducts 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.

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  • 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.

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The VitalScan ANS+ System is a clinically powerful and easy to use non-invasive system to test for hidden diseases. In 15 minutes identify clinical autonomic disorders and uncover major illness and health risks including:

* Sudden Death
* Silent Heart Attack
* Syncope
* Hypertension
* Cardiac Autonomic Neuropathy (CAN)
* Diabetic Autonomic Neuropathy (DAN)
* Vascular Abnormalities
* Orthostatic Hypotension
* Other Hidden Diseases

Testing of the autonomic nervous system is a is a recommended standard of care by the American Diabetes Association for patients with Type 1 and Type 2 diabetes.

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 superventricular 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.

Features


* Arterial Vascular Assessment
* Comprehensive Autonomic Balance Analysis (ANS)
* Cardiovascular Fitness
* Cumulative Mental and Physical Stress
* ECG Analysis
* Heart Rate Variability Analysis (HRV)
* Neurovegetative Analysis with custom measurement marks
* Cardiovascular Health Analysis
* Baroreceptor Sensitivity Analysis
* Full compliance to the Standards of HRV professional analysis
* View progress charts of unlimited sessions
* Functional Age
* Patient History Progress Reports
* Statistical Analysis
* Normative database included based on more than 150 000 assessments
* HRV data comparison to the population norms
* Automatically evaluates quality of data recorded to ensure accuracy of results
* Automatic artifact detection and visual data editing
* Easy-to-read interpretation of the autonomic balance status
* Trains for stress reduction and better inner balance
* Easy-to-use intuitive colorful graphical user interface
* Backed by 30 years of documented medical studies
* Easy software installation and automatic hardware detection
* HRV data export into Microsoft Excel spreadsheet and ASCII text formats
* Supported Languages: English, Spanish, Italian, German, Chinese, Japanese, French

Standard Compliance


* VitalScan ANS+ software was developed according to the standards and mathematical procedures for short-term HRV analysis set forth by:
- The European Society of Cardiology
- The North American Society of Pacing and Electrophysiology

* VitalScan ANS+ is an FDA 510k cleared product. Please contact your local sale representative for more detail information. Some components in the US or EU version may not be available or may be available for research purpose only.

* VitalScan ANS+ also compliance with the following standards:
EN ISO 13485:2003, EN 60601-1:2005/(R)2012, IEC 60601-1-2:2007, IEC 60601-2-27:2011, ISO 80601-2-61:2011, AAMI 80601-2-30:2009/A1:2013, ANSI-AAMI EC57-98, ANSI-AAMI EC13:2002, EMC, Directive 93/42/EEC, CE 0120

Minimum Computer Requirements


* CPU 2 GHz (or equivalent)
* 4 GB of RAM
* Video card with at least 1024x768 and High-Color resolution
* 4 GB of free hard disk space
* One available USB port, version 2 or higher
* Windows 10 Operating system