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| 1. Definition of The EIS System? |
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| The EIS System is a programmable electro medical system (PEMS) including: |
| USB plug and play hardware device with a black box, 6 tactile electrodes and cables |
| installed on a computer/notebook to allow for data processing and modelling. |
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| 2. How Does The EIS Work? |
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| Bioelectrical impedance measurements (BIM) represent a wide range of old and new non-invasive technologies where a small electrical current is applied to the body via one or more surface electrode. The resultant electrical current, passing through the body is detected at other surface electrodes placed elsewhere on the body. |
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| The patented technology of The EIS uses a Direct Current Bioelectric Impedance Technique. In fact The EIS is the only system that uses this scientifically validated approach. |
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| Unlike the more familiar A.C. bioelectric impedance technique, the electrical current produced by D.C. bioelectric impedance passes through the interstitial fluid compartment only. |
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| Since a D.C. electrical current passes solely through the interstitial fluid, it is proposed that an abnormality in the chemical composition of the interstitial fluid could be detected with an adequately sensitive D.C. BIM device; introducing The EIS System. |
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| 3. What are the results obtained during an EIS examination? |
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| Compute various physiological tissue parameters (table 1) within certain organs (Table 2) |
| Statistical analysis of the functional risk (Table 3) of various body systems |
| Biochemical values of interstitial fluid (Table 4) |
| Body composition analyzer |
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| Table 1.List of physiological tissue parameters |
| Parameter1: Intensity in µA |
| Parameter 2: Resistance in Kohms |
| Parameter 3: Conductivity in S.m-1 |
| Parameter 4: pH |
| Parameter 5: Estimation of the VO2 (oxygen consumption) |
| Parameter 6: Estimation of the mitochondria activity |
| Parameter 7: Estimation of the tissue blood pressure and blood flow |
| Parameter 8: Estimation of the tissue blood viscosity |
| Parameter 9: Estimation of the tissue water content |
| Parameter 10: Estimation of the neuronal excitability (Brain EIS) |
| Parameter 11: Estimation of the bone density (Vertebrae EIS) |
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Table 2. List of organs evaluated with The EIS modeling system
The EIS medical system provides a model of the human body in order to
evaluate the physiological tissue parameters of the following organs: |
| Stomach / Duodenum |
Left and right frontal lobe of the cortex |
| Small intestin |
Left and right temporal lobe and limbic system |
| Ascending part of intestin |
prostate / uterus |
| Descending part of intestin |
Bladder |
| Hepatic zone of transversal colon |
Left kidney / Right kidney |
| Splenic part of the transversal colon |
Intracranial vessels (left and right) |
| Sigmoid colon / rectum |
Left and right cardiac ventricles |
| Oesophagus |
Thyroid |
Left and right lobes of the liver /
Gallbladder |
Medullo adrenal / Cortico adrenal |
| Pancreas |
Vertebrae |
| Bronchis / Trachea |
All the lobes of the lung |
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| Table 3.List of statistical functional risks: |
| Respiratory functional risk |
Cardiovascular functional risk |
| Digestive functional risk |
Endocrine functional risk |
| Immune functional risk |
Neurological functional risk |
| Renal and urogenital functional risk |
Metabolic general functional |
| Neuro muscular functional risk |
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| Table 4. List of biochemical values from the interstitial fluid |
| Ionogramme |
Biochemical
constants |
Hormonal
assessment |
Davenport
diagram |
| Ca+ |
Triglycerides |
TSH |
Testosterone /
or oestradiol |
H+ |
| Mg |
Urea |
FSH |
Insulin |
pH |
| Na+ |
Uric acid |
DHEA |
PTH |
CO2 |
| Cl- |
Glucose |
Cortisol |
T3 |
Bicarbonates |
| K+ |
Atherogenic
Quotient |
Aldosterone |
ADH |
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| Phosphates |
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Adrenomedullary |
ACTH |
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| Iron |
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| 4. Why is The EIS Technology different? |
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| The E.I.S System allows for modeling of the human body and the estimation of interstitial biochemical values. |
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| What is modeling? |
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| Modeling is not the same imagery technique conventionally used in medicine. The approach is more like that of a physicist’s. We reduce the diversity and complexity of the body functions by an appropriate choice of assumptions and measurements. |
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| Medical modeling is a control tool and helpful in therapeutic decisions. |
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| Modeling is not intended to reproduce an exact reality; only a model identical to the system could be regarded as an exact representation of reality. Simulation provides comprehension, it makes it possible to formulate theories and to test them which may lead to the understanding of that which is incomprehensible without it, by functioning according to a computer logic. |
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| What are the benefits of interstitial biochemical values? |
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| Interstitial Fluid is a compartment relatively unknown because currently there are no direct methods for sampling interstitial fluid. Extracting a tissue sample was the only way to measure the interstitial fluid before the non invasive method of The EIS was brought to market. |
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The values of interstitial fluid differ from that of laboratory tests.
The specifics of this compartment and the interpretation of the results are not the same as the results of blood or urinary analysis. |
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| The clinical investigations at MARFINO center (Moscow) illustrated that the EIS ionogramme values have similar values to the ionogramme results of the capillary blood. (the results corresponded 89% with a confidence level of 95%) |
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| The pH values are different, (than arterial blood) because interstitial fluid does not have main blood buffering elements (such as Haemoglobin and proteins). The acid base balance of the interstitial fluid is regulated by the cells’ activity and the electrolytic balance between the extra and intracellular medium. |
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| Biochemistry results (atherogenic quotient, glucose, triglycerides, etc.) and hormonal assessment offer different results taken from that of venous blood. |
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| However, the clinical investigations at Botkin Hospital (Moscow 2006) revealed that the TSH results from The EIS system had similar corresponding results to the TSH results from venous blood tests. |
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| 5. Why a new supplementary examination? |
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The EIS system allows specific, repeatable measurements:
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| of the physiological tissue parameters |
| of the interstitial biochemical values |
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For example:
The application of The EIS System with cardiology and Neurology
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| Supplementary Examination |
Electrical activity |
Coronary |
Volume |
Heart Tissue
(O2 / Microcirculation) |
| EKG |
X |
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| Arteriography or EB CT |
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X |
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| Ultrasonic |
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X |
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| EIS |
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X |
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The application of The EIS system as a supplementary examination in neurology
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| Supplementary Examination |
Electrical activity |
Brain structure |
Cerebral blood flow |
Nerve cells activity |
Brain Tissue
(O2 / Microcirculation) |
| EEG |
X |
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| MRI |
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X |
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| CAT Scan |
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X |
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| MEG |
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X |
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| EIS |
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X |
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| The results obtained using The EIS system can not be used to imperatively confirm or deny various laboratory tests, the results of imagery devices, or an electrical activity recording device. Each medical examination or evaluation has its own specificities. The results of the same organ will be varied according to the technique used. The EIS measurements offers new medical data of a complementary nature such as physiological tissue parameters (see table1) as well as biochemical values of the interstitial fluid at a fraction of the cost.(See table 4) |
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| *Oncology: |
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The studies carried out at the Botkin hospital in 2003 made it possible to determine an important specificity (80%) for cancer. However, this specificity was calculated around only one parameter: the pH of the interstitial fluid (metabolic acidosis). This specific parameter was confirmed by several respected peer reviewed publications (62) (63).
However, the sensitivity was low and therefore The EIS scan, could not be considered to provide a valid marker for cancer. However, The EIS scan offers validity as a therapeutic follow up (i.e. as in cancer treatment with chemotherapy) to determine the effectiveness of the said treatment, and to find the associated side effects caused by the respected treatments. This was confirmed by the pre study made at Gustave Roussy Institute (France 2002). |
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| 6. Can The EIS depict specific diseases? |
| The EIS is not designed to depict various diseases, rather it can be used for the screening of dysfunctions that might be associated with certian diseases. The EIS can also be used as a therapeutic follow up tool based upon the physiological tissue parameters, the interstitial biochemical values and the acid base balance measured in interstitial fluid. |
| The EIS System does not provide data on the cell’s blood, nerves, vessels, lymphatic, muscles, and articulations. However all this data can be computed by extrapolation. |
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| Examples of treatment follow up using The EIS system as a clinical marker |
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Effect of corticoid treatment (15 days)
You can see the organs (digestive inflammation) and in the body composition the extra cellular water increased (odema) |
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| Effects of oxygenation (2 hours apart with 20 minutes of initial treatment) |
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| You can see the effect in the digestive system (vasodilatation) and in the brain (neuronal excitability increased |
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| Effect of antibiotherapy (treatment of Echerricha colli after 1 week |
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You can see the vasodilatation of organs and reduction of infection
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| Effect of antidepressant (IRSS after 45 days) |
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The neuronal excitability becomes normal
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| Effect of chemotherapy (after 1 week) |
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You can see the Davenport Diagram before the treatment (metabolic acidosis) and then after the treatment (metabolic alkalosis) |
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| Effects of hypo tensor and anti agregants (after one month) |
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| The Davenport Diagram before the treatment (metabolic alkalosis) and after the treatment (metabolic acidosis) |
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| Hormonal assessment Follow up (1 year) |
| The dosage is modified until hormonal stabilization has occurred. |
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| 7. Who uses The EIS System? |
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| Current distribution demographic: |
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| 1500 systems in Europe and Asia |
| 850 Office Physicians |
| 300 Chiropractors |
| 150 Holistic Therapists |
| 10 Medical SPA’s |
| 5 Pharmaceutical laboratories |
| 90 Integrative Clinics |
| 95 Hospitals |
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| Who should be using The EIS System? |
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| Licenced Physicians operating from an office, clinic or hospital. |
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| Chiropractors |
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| Data mining/statistical research |
| To track the health of a group or demographic population according to certain parameters .as defined by The EIS |
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| Tele-medicine |
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| Detailed reporting system allows for data to be emailed or sms off site to specialist consultants for their review |
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| Medical SPA’s : Used as a “before and after” treatment tool, The EIS is utilized in this capacity to visualize the effects of various prescribed treatments. |
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| Alternative Medicine |
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| Therapeutic follow-up and visualization by the health care professional and by the patient helps realize the benefits of respective alternative treatments. |
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| Sports Medicine |
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Neutraceutical Evaluation
For the first time a non biased system to determine how various nutrtionals impact the human body. |
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| 8. Benefits of The EIS System? |
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| For Health Care Professionals: |
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- “In house” Testing with results available immediately
- Saves time (2 minute test time which can be conducted in the waiting room by a technician (masked time))
- Enroll your patient by showing The EIS test results and setting realistic goals for treatment based upon the data provided by The EIS System.
- The nutritional component of The EIS is derived from a statistical program(STATISTICA) based upon:
- The acid base balance
- The BMI
- The body composition (BIA)
- The statistical main functional risk of the patient
- Therapeutic follow up: Determine the success of medication and or treatment protocols and control the side effects drugs.
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| For the patient |
- To understand their disorder and symptoms in easy to view graphs and images.
- To visualize the effect of the treatment or how the change of their lifestyle (nutrition, stop smoking, exercise…) impacts their wellbeing.
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| 9. What is the accuracy of The EIS System? |
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| Measuring accuracy: |
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Conductivity measurement: The measuring accuracy of conductivity depends on the
imposed voltage and resistance included in the electronic card.
The precision of the imposed voltage is 1.28V +/- 0.04 thus possible errors +/- 3.1%
The precision of resistances is +/- 5 Ohms for the resistance spread out between 11
KOhms and 390 KOhms thus the maximum possible error +/- 0.4%
The precision is therefore: +/- 3.5 % to the maximum |
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Statistical Risk analysis and biochemical values:
The precision of statistical results depends of the type deviation σ, number of patients n and the average of all the measurements for each pathology X according to the formula: σn-1/ X (expressed in %). All the indicated statistical functional risks have specificity with a confidence interval which is calculated at 95%. This estimation is made by an external statistical program STATISTICA version 7.0 |
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| 10. What are the indications of use for The EIS System? |
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| There are 2 types of indications: |
- Check up and screening : The EIS System is a non-invasive bio impedance analyzer used for estimating:
- The body composition: The applicable age range is 10 to 80 years old for sedentary subjects. For athletic subjects, the applicable range is 16 to 60 years.
- The Lifestyle (diet and micro nutrition): the applicable age range is 40yrs to 80yrs
- The Physiological tissue parameters: the applicable age range is 5years to 80 years old.
- The Interstitial biochemical values: the applicable age range is 5 to 80 years old.
- Follow up through the physiological tissue parameters and biochemical values of the interstitial fluid.
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| 11. Contra-indications of The EIS System? |
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| General Contra Indications |
- Dermatological lesions in contact with the electrodes or excessive perspiratio
- This device can not be used in association with or in the presence of defibrillators, cardiac pacemakers, patients connected to electronic life support devices, or any other implanted electronic devices.
- Patients unable to be held upright or seated
- Metal pins or prostheses on the extremities or the joints
- This device can not be used on pregnant women. The effects on the fetus, as well as the accuracy of the readings are unknown.
- An absence of one or more limbs.
- The location of the system: The ground (synthetic material) and relative humidity < 30% can prevent accurate measurements. The system is sensitive to geopathic electromagnetic discharges due to the low voltage signals being generated. by The EIS System.
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| Supplementary contra indications for the calculation of the body composition |
- Age ( < 16 and > 80)
- Fever
- Drugs
- Strong alcohol or stimulants (amphetamines) 12 hours before the examination
- Diarrhoea
- Intense physical activity 8 hours before the examination
- Oedema
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| Warning |
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Training and certification is required to operate the system.
The use of The EIS System requires certification at several training levels. This training is provided by doctors who have attained Level 3. Level 1 is essential to utilize the EIS System.
EIS System certification is awarded upon completion of Level 1 training. |
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| III DISCLAIMER |
- The interpretation of The EIS System requires medical knowledge of physiology, the subject’s clinical context and a list of variables which can modify the results. The interpretation is the responsibility of the health care professional.
- The EIS system does not replace any existing medical examination but is rather considered a supplementary tool.
- The results of the EIS BIM showing no abnormal values does not mean that the patient is healthy; it only indicates that there are no physiological tissue parameter disorders or interstitial biochemical value disorders.
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| Undesirable side effects |
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| No side effects or adverse reactions are known to date. |
| The EIS System delivers far less electrical energy than many other common biomedical devices. Specifically, 84.5 milliJoules (mJ; or 0.0845 J) of electrical energy pass through the body, distributed across different anatomical regions, in the 110 seconds of active scanning in an typical EIS examination. Expressed as electrical power (electrical power is defined as Watts (W). 1 Watt = 1 Joule/s), the EIS System operates at 0.00077 W. To put this figure in perspective, compare the 0.00077 W to a standard incandescent light bulb using 60 W of electrical power. The light bulb draws nearly 78,000 times more energy than The EIS System. |
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