The EIS-BF system uses impedance measurements and modeling of 22 body segments to monitor treatment effectiveness for conditions like thyroid disorders and ADHD, and to provide diagnostic indicators with a reported 78-95% accuracy. It analyzes heart rate variability, photoplethysmography waves, and body composition to estimate autonomic nervous system activity and cardiovascular risks. When used in combination with clinical exams, the system aims to help physicians with diagnosis and guide treatment choices.
13. Diagnosis are hypothesis After the process of elimination , the cross analysis of the clinical context and supplementary examinations , the physician make a hypothesis of diagnosis: because the human body is a complex of balance and all the dysfunctions or diseases have implications in all the body systems
14. Treatment choice Hypothesis of diagnostic Adapted Treatment of the diagnosed diseases issues from the clinical investigations Improvement of the results of the supplementary examinations No Improvement of the results of the supplementary examinations MONITORING Improvement of the clinical context Or Improvement or no improvement of the clinical context Side effect over the benefits of the treatment No validation , misdiagnosis or no responses dues to inter individual difference Validation of the diagnosis hypothesis
19. Blood flow Conductivity measurement accuracy +/-3.5% 2. Modeling** of the Human body according to the conductivity of the 22 segments by mathematical application of the Venn diagram and the normal positioning extrapolation of the body systems. **Accuracy of the modeling ( p<0.001) for the cerebral frontal lobes, digestive system Prostate and thyroid.
20. EIS Features Sequence of the measurement of the 22 body segments ESG graphic: conductivity of the 22 segments ESG normal range values
21. EIS Features (2) Min C O N D U C T I V I T Y Venn diagram calculation Max Modeling Maxwell equation’ s calculation
22. EIS / EFFECT OF THE DC CURRENT IN INTERSTITIAL FLUID Na+ The current is carrier by the ions . The Current is sending from the Anode (+) to Cathode (-) , and therefore the Na+ ( most significant concentration of positive ions in the IF) are moving to the negative pole . The conductivity is proportionally increased with the Na+ concentration and the volume of the interstitial fluid Na+ Na+ Na+ Na+ 1.28 V
23. Na+/K+ pump Na+/H+ anti porterNa+/ATP Production Na+ Na+ Na+ Na+ Na+ H+ Na+ Na+ Na+ Na+ Na+ ATP
26. EIS –BF SYSTEM CLINICAL INVESTIGATIONS UPDATE VERSION 10
27. EIS- BF Clinical Investigations Accuracy for Monitoring of the following treatment (p< 0.001) : Sp 94% No sensitivity Thyroid substitute treatment Hypo tensors ( Beta blockers and CEI) Anticoagulants Antidepressants SSRI Accuracy in Adjunct in conventional diagnosis of the ADHD children: (p< 0.0001) : Sp 95% / Se 78%
68. New products EIS BWS: Wellness and lifestyle ES Teck: Estimated of the ANS activity and of cardiovascular indicators. 510k in progress Nr K083229 ES Teck Complex : Combination EIS /ES Teck ITM Breast imaging by electro impedance.
69. EIS New application : BSW (Body Scan Wellness) Why BSW? Because There is not good or bad diet for every people, there is good or bad diet for each person The change of nutrition need to be monitoring and the good nutrition for each person is not available all his life. Based on the EIS and BC device measurement
70. Why the E S Teck Because HRV ( ANS activity estimation) Photoelectrical Plethysmograph ( Vascular estimation) body composition and the phase Angle measurement Can give new indicators in the process of elimination of the physician’s diagnosis
71. Why the ES Teck Complex Combination of the EIS and the ES Teck: Because : The cross analysis of the indicators issue from 4 different technologies will increase the sensitivity and therefore the accuracy of a medical device
72.
73. The positive predictive value of mammography for breast cancer ranges from 20% in women under age 50.
80. Nutritional Analysis ReportAll results should be considered in the clinical context of the patient's case history, symptoms, known diagnosis, current medications, treatment plan and therapies. This diet analysis does not replace the advice of your practitioner.The estimated body composition is made according to the James equation and the formulas from the peer reviews.
84. ES Teck System (Cardiology) HRV Photoelectrical Plethysmograph
85. HRV ( short time) HRV Reference: Task Force of The European Society of Cardiology and The North American Society of Pacing and Electrophysiology (1996)
86.
87. Takazawa, Kenji; Tanaka, Nobuhiro; Fujita, Masami; Matsuoka, Osamu; Saiki, Tokuyu; Aikawa, Masaru; Tamura, Sinobu; Ibukiyama, Chiharu :Assessment of Vasoactive Agents and Vascular Aging by the Second Derivative of Photoplethysmogram Waveform Hypertension: Volume 32(2)August 1998pp 365-370
88. IToshiaki OTSUKA , Tomoyuki KAWADA , Masao KATSUMATA , Chikao IBUKI , and Yoshiki KUSAMA ndependent Determinants of Second Derivative of the Finger Photoplethysmogram among Various Cardiovascular Risk Factors in Middle-Aged Men Hypertens Res Vol. 30, No. 12 (2007)
89. Toshiaki Otsuka, , Tomoyuki Kawada, Masao Katsumata,ChikaoIbuki, :Utility of Second Derivative of the Finger Photoplethysmogram for the Estimation of the Risk of Coronary Heart Disease in the General Population Circ J 2006; 70: 304 – 310
90. Alberto Avolio: The finger volume pulse and assessment of arterial properties .Journal of Hypertension 2002, 20:2341–2343
94. SpO2 AND Photoelectrical Plethysmography SpO2 Probe Infra red/ Red 660/905 nm Photo diode SpO2% PR Vascular waves
95. SpO2 ANALYSIS Oxygen - hemoglobin Affinity Changes. The functions of hemoglobin are oxygen pickup and delivery. The hemoglobin has an affinity (the strength of bond between oxygen and hemoglobin) that can be increased or decreased due to various situations. If hemoglobin has an increased affinity, it is highly saturated; but oxygen is less available for release to the tissues due to the strong bond. The reverse is also true.
102. Specificity and sensitivity of the b/a and d/a indicators Ref. Toshiaki OTSUKA , Tomoyuki KAWADA , Masao KATSUMATA , Chikao IBUKI , and Yoshiki KUSAMA Independent Determinants of Second Derivative of the Finger Photoplethysmogram among Various Cardiovascular Risk Factors in Middle-Aged Men Hypertens Res Vol. 30, No. 12 (2007)
120. Resistance and Reactance measurements Resistance is a measure of how difficult it is for electricity to flow through an object. Reactance Most objects have some capacitance, which is a measure of ability to store an electrical charge. The more capacitance the object has, or the faster the current changes direction, the less the object will “react” to the current.
123. Impedance Components Phase Angle Xc = 1 / (2 * PI * F * C), C – Capacity [Farad] Phase Angle = Arctan (Xc / R)
124. Clinical application in survival in colorectal cancer The survival curves for the 2 categories of phase angle areshown. Patients with a phase angle < 5.57 had a mediansurvival of 8.6 mo (95% CI: 4.8, 12.4; n = 26), and those witha phase angle > 5.57 had a median survival of 40.4 mo (95%CI: 21.9, 58.8; n = 26); this difference was significant (P= 0.0001).
135. Vascular Indicators PH : Relation with blood flow of small artery EEI : Relation with LV ejection and elasticity of large artery - LV Ejection Insufficiency DDI : Relation with contraction and tension of small artery - Hypertension & Arteriosclerosis DEI : Relation with blood flow to vein system. Etc (Estimated Cardiac Ejection time) : 260~380 Function of left ventricle
159. Statistical risk analysis No access before 5 measurements. The accuracy increased with the number of measurements. Statistical analysis of the indicators of each body systems and metabolic general indicators It is not a diagnosis , but help for the physician in the process of elimination
166. MRI and Ultrasound The specificity of these techniques are inferior to the mammography and do not increased the sensitivity of the screening
167. ITM in adjunct to the Mammography Increase the sensitivity of the breast cancer diagnosis from 20% to 80% for the women under 50 y.o and therefore reduce the number of no necessary biopsies
168. Intended Uses In Gynecology: The ITM is intended for use as: Early detection of mastopathy and monitoring of the mastopathy treatment. Estimated the lactation function for the pregnant women In Oncology: The ITM is intended for use as an adjunct to mammography in patients who have equivocal mammographic findings within ACR BI-RADSTM categories 3 or 4. This device provides the radiologist with additional information to guide a biopsy recommendation. The device is intended for use on women age > 20 years old and increase the sensitivity of the diagnosis of breast cancer in particular for the women under 50 y.o The system will be use by licensed practitioner and the interpretation will be made by radiologists who have satisfactorily completed the training phase of the ITM system.
171. ITM Data acquisition sequence Connect first matrix electrode to voltmeter Connect first matrix electrode to current source Inject current and make measurement Last electrode for injecting? No Connect next matrix electrode to current source Yes Last electrode for measuring? Connect next matrix electrode to voltmeter No Result is 65536 pulses In 22 seconds Yes End of measurements
172. Reconstruction I L x y E z R Re P(x,y,z) - measured electric intensity - reference electric intensity Electrical impedance tomography with planar array enables imaging of three-dimensional distribution of electrical conductivity in subsurface areas (~ 5-cm depth) using flat matrix of 256 electrodes. For the convenience of viewing, the results are represented as the set of
173. ITM Calculation of the electric field intensity 1. Finite-difference approximation on staggered grids: x1 2. Two-dimensional linear interpolation of each component: y2 : electrodes : grid, where Exis defined : grid, where Eyis defined position inside corresponding grid cell
174. The T-Scan 2000 First application of the Impedance Mammography The T-Scan™ 2000 is an electrical impedance scanning device that received approval for marketing from the U.S. Food and Drug Administration (FDA) in 1999, with the following labeled indication: "The T-Scan™ 2000 is intended for use as an adjunct to mammography in patients who have equivocal mammographic finding with ACR Bi-RADS™ categories 3 or 4…” Electrical impedance studies are used as an adjunct to mammography to improve patient selection for biopsy in patients with equivocal indications..
175. ITM Versus T-Scan 2000 V V V V V A A A A A A T-Scan measurements ITM measurements V I ~ ~ Image quality is rigidly limited in T-Scan by the physics of the current flow. The collected data set is poor and no data processing is applicable.In ITM system there are no hard limitations of image quality. The number of electrodes, accuracy of measurements and complexity of reconstruction algorithm are limiting factors. The collected data set is full for given geometry of electrodes.
176. ITM Versus T-Scan 2000 8 images for each breast and only 2 depth slides. 42 electrodes and 2 frequencies 1 image for each breast and 7 depth slides . 256 electrodes and 7 frequencies
182. ITM Clinical investigation protocol performed in accordance with trial protocol approved by the Western Institutional Review Board (WIRB) in Olympia, Washington
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184.
185. Specificity = Mammography + ITM diagnosis is malignant | Biopsy is malignant) = 13/14 = 0.926Specificity = only Radiology diagnosis is malignant | Biopsy is malignant) = 13/14 = 0.926Note that the specificity for malignant biopsy (cancer) is the same for both Mammography + ITM and diagnostic only radiology.Sensitivity Mammography + ITM diagnosis is benign | Biopsy is benign) = 17/26 = 0.654 Similarly, the conditional probability that defines specificity for diagnostic radiology is as follows: Sensitivity only Radiology diagnosis is benign | Biopsy is benign) = 3/26 = 0.115
200. Contract of MaintenanceFree the first yearAnd then US$ 500 / Year If no maintenance contract : Update price : US$ 400Each technical support intervention: US$ 80
