VitalScan Combo Pro is a non-invasive, fully automated computer-based system that provides Heart Rate Variability (HRV), blood pressure analysis and Pulsewave Velocity analysis for quantitative assessment of the Autonomic Nervous System (ANS).
Overstress and immobilization are conventional health risk factors, triggering the development of life threatening specific diseases. VitalScan Combo Pro offers the possibility of Cumulative Physical and Mental Stress Assessment.
VitalScan Combo Pro Pulse Wave Velocity (PWV) analysis is based on physiological phenomenon, observable and measurable in the arterial elasticity and stiffness during blood circulation.
VitalScan Combo Pro is the result of more than three decades of very profound scientific research. Testing can be performed easily in almost all medical branches. VitalScan Combo Pro offers the possibility to manage the effect of any health promoting strategy.
The software and analyses are intuitive, easy-to-use and designed for success in the hands of both medical professionals and non-medical practitioners. Simple hardware and standard computer requirements ensure VitalScan Combo Pro transitions seamlessly into virtually every health practice including clinics, laboratories, sports clubs and wellness centers.
VitalScan Combo Pro products are easily applicable to the course of mass and periodical medical check-ups. Assessments can also be used for regular health control and for monitoring the effects of different treatment methods directed toward the general and specific health condition. Consequently, VitalScan Combo Pro is useful for the prevention of high-professional and paraprofessional morbidity rates in different categories of workers and employees.
VitalScan Combo Pro presents a quick and reliable assessment of basic health risk factors, such as the chronic vegetative misbalance, pathological disorders of the heartbeat activity, the levels of accumulated stress, and the decreased level of physical training.
VitalScan Combo Pro uses cutting edge technology to enable precise measurements of parasympathetic and sympathetic activities in order to assess the autonomic balance in the body (evaluation of the autonomic nervous system's regulatory function).
The VitalScan Combo Pro system is used for objective evaluation and validation of various treatments, for research and documentation, and for evaluation of Autonomic Activity before and after a patient is affected by medication, physical treatment, stress, beta-blockers, or any other factor. The point of intersection is interpreted as the point of Autonomic Balance.
This method of assessment is applicable to many fields of clinical practice such as internal medicine, family practice, cardiology, endocrinology, gastroenterology, and psychotherapy. Heart Rate Variability and blood pressure analysis by VitalScan Combo Pro serves as the basis for evaluating the patient's ANS state before and after treatment, which can provide an accurate and reproducible assessment of treatment effectiveness.
The system is used to objectively confirm or exclude a Cardiovascular Autonomic Neuropathy (CAN), a Diabetic Autonomic Neuropathy (DAN) and other dysautonomia problems.
VitalScan Combo Pro offers possibility of Accumulative Physical and Mental Stress Assessment. Overstress and immobilization are conventional health risk factors, triggering the development of life threatening specific diseases.
VitalScan Combo Pro pulse wave is based on 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. With VitalScan Combo Pro, observations to changes in pressure, blood flow, velocity and profile throughout the whole pulse wave can be made for the clear classification of arterial elasticity.
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 Combo Pro 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 Combo Provides a two-pronged approach to patient evaluation. Firstly, VitalScan Combo Pro is able to detect specific types of autonomic dysfunction which can consequently be linked to a multitude of clinical diagnoses. Secondly, VitalScan Combo Pro 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 Combo Pro makes it principally different from all other classes of diagnostic devices. VitalScan Combo Pro 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
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, vaso-dilating and vaso-constricting agents on arteries.
VitalScan Combo Pro 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.
Initial assessment is the most vital step in managing a patients 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. VitalScan Combo Pro 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 VitalScan Combo Pro Arterial Vascular Assessment is a powerful measure which provides further insight into arterial stiffness.
The information collected during the VitalScan Combo Pro 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:
Ankle/Brachial Index (ABI)
Toe/Brachial Index (TBI)
Arterial Stiffness Index (ASI)
Blood Pressure (Brachial, Ankle)
Classification of Cardiovascular Condition
The information deduced from the VitalScan Combo Pro 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 VitalScan Combo Pro 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:
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. Peripheral Arterial Tone (PAT) is for research use only.
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 VitalScan Combo Pro 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) Coronary Artery Respiratory Assessment (CRA) is for research use only.
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.
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 Combo Pro 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.
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.
Establishing overall health level is key to disease prevention and optimized health. VitalScan Combo Pro presents a systematic and convenient approach to calculating individual overall health. By combining the results of all VitalScan Combo 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 Combo Pro 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 Combo 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 Combo Pro analyses and health testing cannot be overstated as preventative tools and supplementary guides to overall patient health.
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.
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.
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.
Quantitative Sudomotor Axon Reflex Test (QSART) is a test to evaluate the integrity of the postganglionic sudomotor system along the axon reflex to define the distribution of sweat loss. This is accomplished by the release of bio-impedance electrical stimulation the skin which activates receptors on the eccrine sweat gland. The sweat response is recorded from four sites (forearm and 3 lower extremity sites) and assessed for deficits.
The QSART is a test that measures the autonomic nerves that control sweating. The test is useful in assessing autonomic nervous system disorders, peripheral neuropathies and some types of pain disorders. The test requires a mild electrical stimulation on the skin, which allows to stimulate sweat glands. The QSART measures the volume of sweat produced by this stimulation.
QSART is used to diagnose:
Painful, small fiber neuropathy when nerve conduction test results are normal
Disturbances of the autonomic nervous system, which controls the sweat glands, heart, digestive system, other organs, and blood pressure
Complex pain disorders
RSD (Reflex Sympathetic Dystrophy, Complex Regional Pain Syndrome)
Cosmetics/Consumer goods testing
Multiple System Atrophy (Shy-Drager syndrome)
VitalScan Combo Pro provides information that determines the cardiometabolic risk in patients. The test, equivalent to a galvanic skin response stress test, measures the sweat glands' capacity to release chloride ions in response to an electrochemical activation.
The advantages: VitalScan Combo Pro does not require any patient preparation, such as blood drawing or fasting; it is non-invasive and delivers immediate results, with findings that are ready to use after a short and uncomplicated test of merely 2 minutes.
VitalScan Combo Pro has been developed for use by general practitioners, pharmacists, cardiologists and neurologists to assist in the effective screening of cardiometabolic risk in patients.
The VitalScan Combo Pro 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:
Silent Heart Attack
Cardiac Autonomic Neuropathy (CAN)
Diabetic Autonomic Neuropathy (DAN)
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.
Arterial Vascular Assessment
Ankle-Brachial Index (ABI)
Comprehensive Autonomic Balance Analysis (ANS)
Cumulative Mental and Physical Stress
Pulse Wave Velocity
Augmentation Index (AI)
Reflection Index (RI)
Stiffness Index (SI)
Peripheral Arterial Tone Assessment (PAT)
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
Patient History Progress Reports
Normative database included based on more than 300 000 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
* VitalScan Combo Pro 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 Combo Pro 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 Combo Pro 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