3DCCG

Haemoseis 256™

2006-04-23T11:25:00.000-07:00

Haemoseis 256™ (also known as Haemotron) is the medical equipment which enables cardiac evaluation using the technology of 3D Cardiovascular Cartography (3DCCG).

International Certification

CE Mark and Certification
EN 60601-1
EN 60601-2-25
EN 46001
ISO 13485:2003
UL
CSA
TÜV
VDE
USFDA 510 (k)

The Meaning of each Certification Mark

CE: Haemotron is CE certified for the European market. The European Commission describes the CE mark as a "passport" that allows manufacturers to circulate industrial products freely within the internal market of the EU. The CE mark certifies that the products have met EU health, safety and environmental requirements that ensure consumer and workplace safety. All manufacturers in the EU and abroad must affix the CE mark to those products covered by the "New Approach" directives in order to market their products in Europe. Once a product receives the CE mark, it can be marketed throughout the EU without undergoing further product modification. Haemotron is CE approved: C51026, dated: April 09, 2002 'Haemotron 36-4th Generation'.

EN 60601-1: European baseline standard for safety of all medical equipment. The Haemoseis 256/Haemotron is EN 60601-1 certified.

EN 60601-2-25: European standards. Specifies particular safety requirements for medical equipment such as electrocardiographs, for diagnostics purposes. Also applies for vectorcardiographs and equipment for stress testing. The Haemoseis 256/Haemotron is EN 60601-2-25 certified.

EN 46001: The European Quality Systems standard for Medical Device Manufacturers. The Haemoseis 256/Haemotron is EN 46001 certified ISO 13485The Haemoseis 256/Haemotron is ISO 13485 certified.

UL: Underwriter Laboratories (UL Mark) for safety for dental and medical equipment. This certification covers all equipment intended for professional use by personnel in hospitals, nursing homes, medical care centers, medical and dental offices and other Health Care Facilities. The Haemoseis 256/Haemotron is UL approved.

CSA: Canadian Standard Associations Safety requirement. CSA International is accredited in the U.S. by the Occupational Safety and Health Administration (OSHA) as a Nationally Recognized Testing Laboratory (NRTL), and in Canada by the Standards Council of Canada (SCC). The Haemoseis 256/Haemotron is CSA approved for the Canadian market.

TUV, VDE: German electrical safety standards. In Germany electrical equipment must comply with the 'Equipment Safety Law' and approval by VDE or TÜV to VDE and DIN VDE standards is the usual way of demonstrating this compliance. The Haemoseis 256/Haemotron is TÜV and VDE approved.

USFDA: The United States Food and Drug Administration standard for medical equipment.Haemotron has USFDA 510(k) registration 9710449 , owner number 9047192.
To view the original online device listing in FDA's database, visit : http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/search/search.cfm?db=LST&ID=75267
Device Listing Database
Proprietary Device Name: HAEMOTRON
Common/Generic Device Name: HAEMOTRON
Classification Name: COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION
Device Class: 2
Product Code: DXG
Regulation No: 870.1435
Medical Specialty: Cardiovascular
Owner/Operator: IMRE JAKOBICZ
Owner/Operator No: 9047192
Registered Establishment Name: ASKIT KFT
Establishment Registration No: 9710449
Date of Listing: 07/12/01
Listing Status: Active
Establishment Operations: Manufacturer

Clinical Applications

2006-04-21T05:12:00.000-07:00

3DCCG offers an easy, quick, safe, reliable and repeatable bedside procedure to evaluate the cardiovascular dynamics in very minute details otherwise available only through very elaborate invasive and special cardiac laboratory procedures.

Some of the clinical and applied uses of 3DCCG are as follows:

Early detection of Coronary Artery Disease (CAD) in asymptomatic subjects, especially those with significant coronary risk factors.
Provide quantifiable evidence for myocardial ischaemia in the management of acute chest pain due to CAD.
Offering information on alternative mechanisms for the underlying cause of chest pain in the absence of CAD.
Non-invasive monitoring of vital functions in critical care medicine.
Haemodynamic evaluation of the very old, very young or critically ill patients.
Close monitoring of pharmacological response and choice of most suitable drugs in critical care.
Pre-operative assessment of cardiopulmonary fitness.
Monitoring of minute changes taking place in the cardiovascular system (every millionth of a second).
Measurement of inotropic effects.
Monitoring effects of anaesthesia - during general narcosis and regional techniques.
Monitor and control effectiveness of therapeutic drug treatment.
Vital monitoring of neonates when invasive procedures are impossible: monitor neonatal circulatory status, neonatal circulatory adaptation and patent ductus arteriosus.
Evaluate arterial compliance as well as left ventricular compliance.
Bedside evaluation of myocardial perfusion following recent or past revascularization procedures such as PTCA, stent implantation and CABG surgery.
Assess the autonomic system predominance.
Establish proneness to Sudden Cardiac Death Syndrome (SCDS).
Establishing ANS activity in patients with Diabetic Neuropathy.
Assessing and controlling Thrombogenicity in cardiac patients.
Demonstrate detailed evidence of early atherosclerosis well before CAD.
Acquire parameters of pulsatile changes due to systole and diastole during the entire cardiac cycle.
Establish pliability of the mitral and aortic valves in valvular heart diseases.
Cardiac rehabilitation of post-MI, PTCA and CABG patients.
Conduct safe and cost-effective mass coronary screening of at-risk individuals for high risk occupations, aviation, health insurance, corporate sectors, off-shore operations, defence and paramilitary forces, government departments, educational institutions, etc.
Prediction and early detection of pulmonary oedema and left ventricular failure.
Effective monitoring of patients before, during and after procedures like External Counter Pulsation (ECP) or Intra-Aortic Balloon Pump (IABP), where measurement of coronary perfusion pressure, coronary blood flow, and valvular pliability is essential.
Optimising AV-delay in dual chamber pacemakers.
Clinical evaluation of metabolic and endocrinological disorders with cardiovascular complications.
Clinical and applied research in cardiopulmonary and physiology and metabolism.

The ease, accuracy and repeatability of the test will render it very useful for physicians in carrying out clinical research involving cardiovascular parameters in many disease conditions. Accurate evaluation of the haemodynamic functions in many non-specific conditions might be very valuable in identifying sub-clinical cardiovascular changes or pre-existing disease conditions.

Dr GS Nayar

Technology Overview

2006-04-21T05:06:00.000-07:00

3-Dimensional Cardiovascular Cartography (3DCCG) for non-invasive mapping of cardiac functions is a scientific breakthrough in cardiovascular medical technology. The technology involves the latest scientific research in advanced mathematics, modeling, simulation, artificial neural networks, digital signal processing and dynamic fluid mechanics used in space technology.

It uses the advanced patented technologies of Trans-Aortic Signal Wave Modulation (TASWM) and Flow Turbulence Accelerometry (FTA) to measure and record minute changes that take place in the cardiovascular system every millionth of a second. It is the first to use ICG, ECG, PCG and NIBP (automatic non-invasive blood pressure measurement) in one system.

3DCCG thus provides a detailed analysis of cardiovascular haemodynamics, electrodynamics, pulmonary dynamics, detailed regional and myocardial blood flow functions, arterial compliance, ANS predominance and much more in less than 15 minutes.

The self-generated report provides unique details even of miniscule deviation in flow patterns, invaluable for accurate monitoring of cardiac functions and to evaluate cardiac or cardiovascular disorders.

3DCCG pioneers the introduction of a noninvasive medical tool to provide detailed analysis of total cardiovascular flow functions. It can detect signs of early development of CAD at the very beginning stages of atherosclerosis with 98% PPA and a mean accuracy of 91%. Risk free, accurate, non-invasive and cost-effective assessment of cardiovascular functions can be provided for clinical evaluation, general health screening, monitoring of therapy, and medical research. It empowers the physician with unique data and details of the circulatory system, never before possible in a single test.

3DCCG offers a painless, safe and quick test which can be repeated any number of times without risks and with equal accuracy on all groups of patients of all ages. The equipment is excellent for all cardiac diagnostics as well as general health screening, and for use on sensitive patients unable to undergo invasive procedures. Tests can be safely conducted even on neonates and infants.

Dr GS Nayar

Cardiovascular Cartography

2006-04-20T00:02:00.000-07:00

"A multi-variable mathematical model specific to each individual can be designed to obtain the nominal basal haemodynamic behaviour. By superimposing the measured data obtained from the individuals on a predictive model, a pattern called cardiovascular cartography (CCG) can be generated. In a pilot study it was observed that coronary artery disease (CAD) characteristically altered the CCG pattern. These alterations were carefully analysed using artificial neural networks and the exact status of the coronary insufficiency was reconstructed on a realistic geometry coronary model. A strong correlation was found to exist between functional structures and structural functions. This study was designed to assess the feasibility of using such modeling and cartography techniques to detect the primary presence and assess the severity of CAD."

The above quote is the abstract of a scientific paper: " Cardiovascular Cartography - A New Non-Invasive Technique to Detect Coronary Artery Disease" by Kumar RV, Shirbur GN, Augustus RJ, Lakotosh J and Jakobicz I, presented at the 14th IEEE Symposium on Computer-Based Medical Systems CBMS 2001, Bethesda, Maryland 26-27 July 2001.

The technology has been widely applied in the non-invasive evaluation of haemodynamic functions of heart with special reference to myocardial blood flow.

More information on this novel technology and its applications will be discussed in the subsequent postings.

Dr GS Nayar