2. L.D TECHNOLOGY
USA
SOFTMED TECHNOLOGY
EUROPE DISTRIBUTION
Training support
training.ldteck@gmail.com
Technical support
Support.ldteck@gmail.com
Manufacturer
and
Developer
Information
3. FDA & CE Registration Data File
Product Code: HCC
Regulation Number: 882.5050
Manufacturer, Specification developer:
L.D Technology
Biofeedback Class 2
Class 1
Active, non invasive medical device for
diagnostic and monitoring
REGISTRATION
93/42 CEE
4. Clinical investigations
In progress:
IRB FDA approval: Harvard
Medical School
McLean Hospital:
New possibility for diagnosis of
unipolar and bipolar depression
Gustave Roussy Institute (Oncology France)
Saint Louis Hospital (Andrology France)
Botkin hospital (meta analyses Moscou)
Marfino center( biochemical value and BIM
Moscou)
Botkin Hospital (Follow up therapy Moscou )
Caudal Frederique ( ADHD children France)
5. Indications and Intended Use
of the EIS SYSTEM.
Estimation of the
Body composition:
The applicable age range is 10 to 80 years old for
sedentary subjects. For athletically active subjects, the
applicable range is 16 to 60 years old.
By organs:
Estimation of Physiological tissue and
blood parameters:
pH, O2, pressure
Applicable age range is 5 to 80
In general:
Estimation of Interstitial fluid
biochemical values: pool of
ionograms, hormonal,
neurotransmitters
Applicable age range is 5 to 80
6. Clinical applications
of the EIS SYSTEM.
The EIS System is a non-invasive bio-impedance analyzer used in
estimating:
Neurologic disorders
Lifestyle evaluation
Pains visualization and evaluation
Early Treatment or lifestyle change Follow-up and
visualization
Nutritional analysis
7. DISCLAIMERS
• The interpretation of the EIS System requires medical knowledge in
the areas of physiology, adequate references, the subject’s clinical
context, and a list of variables which can modify the interpretation of
results. The interpretation is the responsibility of the health care
professional.
• The EIS System does not replace any existing medical
examination
• This device is not intended to be used for therapy, or treatment of
diseases.
• The result of the EIS BIM without any abnormal values does not mean
that the subject is healthy; it means only that there are no detected
physiological disorders at the tissue levels.
8. .
Contraindications
Contraindications are situations making it impossible to take an accurate EIS
measurement/scan, and/or to make a correct interpretation of the data gathered.
Dermatological lesions in contact with the electrodes or excessive
perspiration
Presence of defibrillators, cardiac pacemakers, patients connected to
electronic life support devices, or any implanted electronic device
People unable to be scanned while seated or standing
Metal pins or prostheses at the level of the extremities or the
joints
Pregnant women ([6 months-plus] the effects on the fetus, as well as accuracy of readings are
unknown)
Absence of one or more
limbs
9. Undesirable Side Effects and Adverse Reactions
The EIS device delivers far less electrical energy than many other
common biomedical devices.
Specifically, 84.5 milliJoules (mJ; or 0.0845 J) of electrical energy pass
into the body, distributed across different anatomical regions, in the 110
seconds of active scanning during an EIS examination.
Expressed as electrical power (electrical power is defined as Watts [W])
-- One Watt = 1 Joule/s) -- the EIS device operates at 0.00077 W.
The EIS System
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 seventy eight thousand
(78,000) times more energy than the EIS device.
No side effects or adverse reactions are known to date.
10. Power supply 5V (power supply by USB port)
Type of Current Direct current
Power consumption 200mA
Classification Class II
Degree of protection against electric shocks BF
Operating mode Continuous use
Tension on the electrodes, in operating mode 1,28 V
Speed transmission 12 Mbd
Galvanic decoupling of the analogical part, 3 KV
Dimensions in mm 128 X 143 X 33
Weight kg 1,2
Component Technical specifications
2 disposable forehead electrodes Ag/AgCl @ 15.75 cm2
2 reusable hand plates Polished stainless steel grade AISI 304 Size:272
cm2
2 reusable feet plates Polished stainless steel grade AISI 304 Size :330
cm2
3 audio-type cables to connect
electrodes/ plates to the
electronic controller box
long armored insulated cables.
Color-coded for ease of use. Red one on the left
Black one on the right
USB cable long standard USB cable connecting electronic
controller box to PC.
PC See requirement of the computer
11. Computer specifications
Windows XP, ….
Apple Mac systems requirements of Windows
Processor type Intel Pentium 4, Pentium M INTEL Dual Core Processor or higher
RAM 512 Mo
Hard Disc or Higher
Graphics card Minimum memory 128K
Gaming card
Desktop:
ATI Radeon X300, X600, X800 or higher
NVIDIA 6200, 6400, 6600 or higher
Intel 945 or higher
Laptop:
ATI mobility Radeon X300, X600, X800 or higher
NVIDIA Ge Force Go 6200, 6400, 6600 or higher
Intel 945 or higher
Screen Size Any
Screen Resolution 1280 X 800
Accessory Software Word or WordPad or Open Office
Accessory USB Ports 2.0
Accessory CD or DVD-ROM
Accessory Audio
12.
13. EIS-PRO
STATIONERY AND INTEGRATED MODEL
EIS-PRO
STATIONERY AND INTEGRATED MODEL
Touch screen
Hand plates
Feet plates
Patient’s chair
Printer
15. The EIS System
Uses the impedance technique
Bioelectrical Impedance Measurements (BIM)
1. Schoeller DA. Bioelectrical impedance analysis. What Does It Measure? Ann NY Acad Sci. 2000;904:159-162.
2. Rigaud B, Morucci JP. Bioelectrical impedance techniques in medicine. Part III: Impedance imaging. First
section: general concepts and hardware. Crit Rev Biomed Eng. 1996;24:467-597
3. Jain RK. Transport of molecules in the tumor interstitium: a review. Cancer Res. 1987;47:3039-51.
4. Brodie D, Moscrip V, Hutcheon R. Body composition measurement: a review of hydrodensitometry,
anthropometry, and impedance methods. Nutrition. 1998;14:296-310.
A non-invasive technology where a diminutive
electrical current is applied to the body via a
surface electrode, and the electricity that passes
through the body is detected at other surface
electrodes placed elsewhere on the body.
A drop in voltage occurs as the current encounters
A.C. impedance (D.C. resistance) inherent in the
fluids and tissues through which it passes, as it
courses through the body’s physiological
compartments.(1)(3)
These compartments include the bloodstream, the
intracellular space, the lymphatic system, the
interstitial space, and others(3)(4)
; providing indirect
data about the physical and chemical properties of
the compartments.
17. APPLICATION OF IMPEDANCE IN MEDECINE
1. Sports & Health Medicine
Body Mass Measuring Devices (ratio of lean mass to fat mass)
"The Biological Impedance Analyzer resistance readings were extremely stable. They exhibited virtually
no change within the five measurements when the electrodes were kept in place. The accuracy of the
measurement of resistance was checked using 250, 400, 500 and 750 ohm precision resistors. The
measured resistance did not deviate from the expected values by more than ± 2%."
Segal, K.R., Gutin, B., Presta, E., Wang, J., Van Itallie, T.: Estimation of human body composition by electrical impedance
methods: a comparative study. Journal of Applied Physiology, 58 (5): 1565-1571, 1985.
18. APPLICATION OF IMPEDANCE IN MEDECINE
3.Medical Tomography
(breast cancer screening)
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. The T-Scan™ 2000 boasts the same
accuracy percentage as mammograms.
19. The EIS System’s specificity
Advanced Patented Technology
Bioelectric impedance measuring systems
typically deliver to the body A.C. electricity at a
wide range of imperceptible currents,
frequencies, and voltages that are far below any
level that could cause cellular or tissue damage.
(1)(2)
Studies of A.C. bioelectric impedance
measuring systems operating at 50 MHz or
higher revealed that these high frequency A.C.
electric currents flow non-selectively through
both intracellular and extracellular spaces.(3)
However, unlike A.C. bioelectric impedance, the
electric current produced by D.C. bioelectric
resistance methods distinctively passes only
through the interstitial fluid compartment.(4)
1. Gandhi OP. Electromagnetic fields: human safety issues. Annu Rev Biomed Eng. 2002;4:211-34.
2. Valentinuzzi ME. Bioelectrical impedance techniques in medicine. Part I: Bioimpedance measurement. First
section: general concepts. Crit Rev Biomed Eng. 1996;24:223-55..
3. Hanaki N, Ishikawa M, Nishioka M, Kashiwagi Y, Miki H, Miyake H, Tashiro S. Bioelectrical impedance analysis to
assess changes in body water compartments after digestive surgery. Hepatogastroenterology. 2006;53:723-9.
4. Kyle UG, Bosaeus I, De Lorenzo AD, Deurenberg P, Elia M, Gomez JM, Heitmann BL, Kent-Smith L, Melchior JC,
Pirlich M, Scharfetter H, Schols AM, Pichard C; Composition of the ESPEN Working Group. Bioelectrical
impedance analysis--part I: review of principles and methods. Clin Nutr. 2004;23:1226-43.
A.C. – D.C. paths through the body
20. Total water
60 % total
body water
Extracellular water
20% total body water
Interstitial fluid
16% total body water
250KHz 50KHz
D.C.
Since D.C. electricity only passes through the interstitial fluid and the
interstitial fluid is not buffered, abnormalities in the chemical
composition of the interstitial fluid can be detected with an adequately
sensitive D.C. bioelectric impedance measuring systems/device – The
EIS System.
Most physicians are forced to ignore the data of 16% of the body
composition and function, as this data is stored in the interstitial fluids
and is not available for analysis -- until now.
21. 2. Any substance passing between cells and the
bloodstream must traverse the interstitial space.
These substances include oxygen, carbon dioxide,
glucose, as well as thousands of other
compounds .
• (Gilanyi M, Ikrenyi C, Fekete J, Ikrenyi K, Kovach AGB. Ion concentrations in subcutaneous interstitial fluid: measured versus expected values. Am J
Physiol 1988;255:F513-9)
• Niels Fogh-Andersen, Burton M. Altura, Bella T. Altura, and Ole Siggaard-Andersen; Composition of Interstitial Fluid CLIN. CHEM. 41/10, 1522-1525
(1995)
• Importance of the Cotrell equation for biosensors study.Journal of Applied Physiology 67(5): 1210-1519, 1998
• Nyboer J, Bango S,Barnett A and Halsey RH: Radiocardiograms-the electrical impedance changes of the heart in relation to electrocardiograms and
heart sounds.J.Clin. Invest. , 19:963 ,1940
Image source:
http://training.seer.cancer.gov/module_anatomy/unit7_3_cardvasc_blood2_physiology.html
No direct methods forNo direct methods for sampling interstitial fluid are currently available.interstitial fluid are currently available.
The composition of interstitial fluid, which
constitutes the environment of the cells and is
regulated by body homeostasis, has previously
been measured bythe suction blister or liquid paraffin techniques,
or by implantation of a perforated capsule or
wick.
1. Interstitial fluid differs from whole blood by the
absence of red blood cells, and it differs from blood
plasma in that there are far fewer proteins (51). The
absence of haemoglobin and poor level of proteins
which are the main buffers of the blood system
explains a more acid interstitial pH(7.33) and more
importantly, the variations in interstitial fluid gases
and blood gases .
The results varied, depending on the sampling
technique and animal species investigated.(1)
3. The volume of the interstitial fluid is closely related to the containing sodium
pool
22. When the sodium concentration decreases in the interstitial fluid, the
sodium moves inside the cell and affects the tissue(s) as follows:
1. Cellular volume increases
2. Mitochondrial activity decreases and ATP production decreases
3. Oxygen consumption decreases
4. Intracellular exit of K+, and H+ ions to the interstitial fluid causing
an interstitial acidosis and an intracellular alkalosis. Note that The
interstitial and intracellular acid base balance are according to cells
activity due to the absence of haemoglobin and proteins (buffers)
5. An interstitial Chlorine retention and a corresponding retention of
intracellular bicarbonate
6. CO2 increases interstitially resulting in an increase in the elimination
of CO2 via blood circulation by the lungs
7. Interstitial fluid volume decreases, the oncotic pressure is more high
that the hydrostatic pressure
8. Blood microcirculation: vasodilatation and blood viscosity
Cells activity and ionic equilibrium
24. When the sodium concentration increases in the interstitial fluid, the
sodium moves outside of the cell and affects the tissue(s) as
follows:
1. Cellular volume decreases
2. Mitochondria activity increase and ATP production increases
3. Oxygen consumption increases
4. Interstitial K+ and H+ ions move into the cell causing an interstitial
alkalosis and an intracellular acidosis
5. Interstitial Chlorine moves to intracellular space, and a
corresponding intracellular decrease of bicarbonate
6. Interstitial CO2 decreases and a corresponding decrease in the
elimination of CO2 via blood circulation by the lungs
7. Interstitial fluid volume increases, the hydrostatic pressure is more high
that the oncotic pressure
8. Blood microcirculation, vasoconstriction and blood viscosity
increases
Cells activity and ionic equilibrium
30. Modeling and localization
of the organs
Mathematical principles:
Direct methods
Inverse problems
Electro Interstitial ScanElectro Interstitial Scan
E.I.SE.I.S
31. Foreword on modeling
• The E.I.S device allows a modeling of the
human body.
• What is modeling?
• Modeling is not the same imagery
conventionally used in medicine. The
approach is more like that of a physicist. We
reduce the diversity and complexity of the
bodily functions by an appropriate choice of
assumptions and measurements.
• We choose for EIS modeling the following
parameter: the conductivity of interstitial
fluid
32. Modeling design
Modeling is a mathematical reconstruction using:
• Direct problem: direct measurements analysis
• Inverse problem:The mathematical algorithms of the
“inverse problems” based upon the following
principle:
Each phenomenon is governed by equations with
parameters, like the initial conditions or various
coefficients; when some of these parameters are
unknown, we are within the framework of inverse
problems, and we can find the unknown parameters
using the results of experimental measurements to
solve the problem.
33. Twenty-two (22) volumes of interstitial
fluid are sampled during the EIS.
Measurement in direct problem.
46. How The EIS System’s
Advanced Patented Technology Operates
In just three (3) consecutive steps, The EIS System generates 3 diverse pulse
sequences, for different durations.
Step
#
Sequence
Type
Pulse
Duration
Pulse
Count
Purposes
1 A.C. 1 sec. 22
1. Body composition
2. Improve signal-to-noise ratio
2 D.C. 1 sec. 22
1. Interstitial conductivity measurement
2. Determine maximum conductivity
value and modeling
3 D.C. 3 sec. 22
1. Interstitial biochemical analysis
2. Determine minimum conductivity
value
Body composition
Signal-to-signal ratio
A.C. 50KHz
Interstitial fluid
Maximum conductivity
D.C.
Interstitial fluid
Minimum conductivity
D.C.
62. 21
22
1
2
3
4
5
6
7
9
10111213
14
15
16
17
18
19
20
86
Cardiovascular risk
Respiratory risk
Type II Diabetes
5
Cardiovascular and
Respiratory risk
4
Hypertension
Hyperaldosteronis
m
hypercorticism
3
Cardiovascular
risk Digestive
risk
2
Hypertension
Nephropathy
Infections
9
Neuromuscular or
articular or
osseous disorders
7 - 8
Respiratory risk
1 -22
Digestive and osseous
disorders
10
Neuromuscular
and osseous risk
muscular
atrophy
Osteolysis
11 -12
· Chronic asthenia
· Depressive
states, .
Migraines
·Digestive
disorders
13
Cancer
Chronic hepatitis
14
Renal disorders
Cancer
15
Hepatic
insufficiency
Respiratory disorders
Drugs side effects
18-19
Respiratory risk20
Hepatic disorders
21
Hepatic and
pancreatic disorders
16
Cardiac
insufficiency and
Drug or food side
effects
63. BODY COMPOSITION
The calculation of the body composition is made according to the Bioelectrical Impedance
Analysis (BIA) .
The BIA is segmentary analysis and uses a range of frequencies between 5Hz and 200 KHz.
64. LIFESTYLE AND
NUTRITION AND MICRO
NUTRITION
• The recommended or not recommended
foods are temporary (4- 6 weeks), and will
be revised at the next examination:
• The recommendations are compiled by a
statistical analysis program which
considers the acid-base balance, the main
functional risk, the brain analysis ,the
BMI and the body composition. Only the
EIS can incorporate all parameters to
correctly analyse the best nutrition for
each person
65. Nutritional and micro nutrional
program Analysis
BMI
Acid base balance
Body
composition Risk
Brain analysis
67. Aide à la consultation
Assistance at the consultation
The patient is not always capable of objectively
describing his or her symptoms. Often they exaggerate
or under-estimate symptoms or choose
not to speak of them because they are taboo or
so old that they are part of the daily routine.
In addition, certain diseases in development or
established present no symptoms.
The EIS system which allows the visualization of parameters
of tissues and blood helps guide the consultation
and eventually helps to better understand the patient’s
psychological factors and, through a statistical analysis
of the risk involved, to prescribe certain targeted
supplementary examinations.
68. Aid to therapeutic decision
making
• the calculations performed by the computer are
1000 times quicker than the human brain (the
computer can perform 50,000 operations each
second). Nowadays practitioners who practice
functional medicine are in the same position as
were accountants before the adding machine.
The adding machine has not done away with the
accountant; it simply allows the accountant to
perform his profession differently. The EIS, with
its measured parameters and analytic software,
can represent the same advance and change the
means of exercising the medical profession into
one more rational with higher mastery.
69. Therapeutic follow-up
• Through visualization of a tissue’s parameters , the EIS
is positioned as the first step to visualization for all
treatments. Actually, whether the treatment is allopathic
or functional (alternative) or nutritional or micro
nutritional, the results are quickly seen firstly at the level
of cellular activity of the targeted organ and therefore at
the tissue level, much later at the blood level and even
later at the structural level (imagery).
• In addition, this therapeutic follow-up is non-invasive
and very low cost. There are no good or bad treatments.
There is only a treatment adapted for each person. With
a therapeutic follow-up you can, as quickly as possible,
visualize if a treatment is correct for the patient...
whether it is effective, adapted and if there are side
effects. This aspect is important for the practitioner who
can at all times control and master the treatment
(efficacy, side effects, dosage) and equally for the patient
who can visualize their good prescription and the control
of his or her treatment.
70. Biofeedback therapy for certain
dysfunctions and stress
• The biofeedback therapy proposed by EIS
permits regulating certain parameters of
tissues and blood and from this, to
rebalance certain dysfunctions such as
digestive problems, stress, insomnia or
chronic fatigue, etc.
71. Improves patient compliance
with their treatment
• The ability to visualize by EIS modeling of organic
problems in connection with certain symptoms reassures
the patient. In effect, some pains or symptoms which
have no explanation at the level of conventional exams
can leave the patient feeling hopeless and/or helpless,
since practitioners may propose no treatment, or
treatments that are often difficult to understand
(functional or alternative medicine).
• By visualizing an improvement of values by EIS
modeling, the patient can better accept the treatment.
• Likewise, a patient who presents with a pathology and
for whom the practitioner prescribes an allopathic
treatment of long duration needs reassurance of its
efficacy, its correct dosage and eventually that it does not
cause side effects that are more dangerous than the
illness for which he or she is being treated.
74. ONCOLOGY
• The tests 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 interstitial fluid
(metabolic acidosis). This specific parameter has also
been confirmed by several respected publications (62)
(63).
• However, the sensitivity scoring is very low and
therefore the EIS scan, as a screening, can not be
considered to be a validation and marker for cancer.
However, the EIS scan has validity as a therapeutic
follow up (i.e. as in cancer treatment with
chemotherapy) to determine the effectiveness of
treatment, and to find associated side effects caused by
the treatment. This has been confirmed by the pre study
made in Gustave Roussy Institute (France 2002).
76. Effect of
oxygenation (20
minutes).
You can see the
effect on the
digestive system
(vasodilatation)
and in the brain
(neuronal
excitability
increased).
BeforeNow
77. Effect of anti-
biological therapy
(treatment for
Escherichia coli after 1
week)
You can see the
vasodilatation of
organs and reduction
of infection.
Effect of
antidepressant
(IRSS after 45 days)
The neuronal
excitability became
normal.
BeforeNow
78. Follow up of thyroid treatment 1
TSH 9 before treatment dose 80µg
79. Follow up of thyroid treatment 2
dose 120µg dose 100µg
80. Hormonal assessment and follow-up over the course of one 1 year.
The doses prescribed can be adjusted until satisfactory stabilization is reached.
81. Effect of
chemotherapy (after 1
week). You can see in
Davenport Diagram
before the treatment
(metabolic acidosis)
and after the
treatment (metabolic
alkalosis)
Effect of hypotensor
and anti-aggregate
drugs (after one
month).
In Davenport Diagram
before the treatment
(metabolic alkalosis)
and after treatment
(metabolic acidosis)
results are obvious.
BeforeNow
82. Effect of auriculopuncture on the catecholamine after 10
minutes (Right ear: Cosmonaut, O’, SPM points)
AFTER
BEFORE
89. • 1. The results obtained by the EIS system
should not be used imperatively to
confirm nor deny laboratory tests, the
results of imagery devices, or an electrical
activity recording device. Each medical
examination or evaluation has its own
specificities and results on the same organ
can be different according to the
technique used . EIS scanning brings new
elements of a complementary nature such
as physiologic tissue and blood parameters
as well as the biochemical values of the
interstitial fluid.
90. 2. Biochemical values, EIS and Laboratory
tests: further comments
• There are differences in concentration of the biochemical values for each
compartment.
• All the values of interstitial fluid are different from the laboratory tests
For 2 reasons:
The interstitial fluid is static no circulatory
The biochemical interstitial values are the pool of a substance and not
the concentration
• The pH values are different, (i.e. than arterial blood) because interstitial
fluid does not have the main blood buffering elements (such as Haemoglobin
and proteins). The acid base balance of interstitial fluid is regulated by the
cells’ activity and the electrolytic balance between the extra and
intracellular medium.
• The clinical investigations at Botkin Hospital (Moscow 2006) show that the
results of TSH from EIS system have similar evolution to the TSH results of
venous blood.
91. 3. The EIS modelling is a representation of
the organs as well as the physiopathology
of interstitial fluid which traverses them.
The physiopathology of interstitial fluid
will be a direct reflection of the cellular
activity of these organs. EIS does not give
information about the physical structure
of organs.
92. 4. The risk analysis and the
possibility of disorders are
statistical and come from
algorithms made from clinical
investigations included in
external statistical program .
These possibilities are not
diagnostic
93. 5. The interpretation of an EIS scan must not be based only
upon a comparison between the result(s) and the
reference values provided by the scan. Interpretation
also requires a definition of physiological limits. On the
other hand, physiological limits of decision fluctuate
according to the objectives:
– Established diagnosis
– Follow-up of the patient
– Diseases considered
– Possible therapies
– Prevalence
Just like laboratory tests, the interpretation of the EIS
requires that the user has medical knowledge of
adequate references and a list of variables which can
modify the results
94. 6. The EIS device provides a lot of results, but for the
interpretation of cases, you do not need all the data. The
EIS device is a modeling of the human body and perhaps
my point will be better understood if we make a comparison
with another type of modeling, the GPS (Global Positioning
Service).
GPS is a modeling allowing one to find the specific directions
about how to get to a specific destination. To use a GPS, you
must first input both the departure address and the
destination address. For the EIS system, the interpretation
requires the same information: the departure address is the
clinical context (check up, known pathology, symptoms, any
treatment in progress, antecedents etc.), the destination
address is the goal you wish to achieve for the client and
what parameters you need to check in relation to the
departure address (clinical context)
95. 5 of the strongest points about the EIS
System, as well its non-invasive nature, are:
POWERFUL POINTS
2. Visualization of the Pains
3. Nutritional analysis
1. New diagnoses approach in neurological
or psychological disorders
4. Biochemical pool estimation
5. Early follow up and visualization of life style
and all therapies
Editor's Notes
Thanks you for choosing the EIS system to help you in your activity. The EIS system will be indispensable in your daily activities if you understand how it functions and are able to interpret its results. Realizing that your time is precious, we have created this training procedure in a way to bring you up to speed as quickly as possible.
This presentation, including level 1 training is indispensable for correct utilization of the EIS system. A certification will be sent you by Internet following your response to a certain number of questions which will permit an evaluation of your aptitude in using the system correctly according to its claims and its performance.
This presentation includes two important parts:
A review of cell physiology
The clinical benefits of the EIS system in your daily practice
Enclosed are coordinates of the manufacturer and contacts for all questions dealing with interpretation and technical problems.
Registration of the EIS system.
Read the text
Read the text
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Supplementary contraindications for the calculation of the body composition and not for all applications
Age ( < 10 and > 80)
Fever
Drugs
Strong alcohol or stimulants (amphetamines) 12 hours before the examination
Diarrhoea
Intense physical activity 8 hours before the examination
Edema
No side effects or adverse reactions are known to date
LD TECHNOLOGY does not guarantee the results in the event of use of other electrodes.
The results are dependant on the nature and the size of the electrodes used.
Instructions to carry out preventive maintenance and maintenance frequency
Ø Storage: the device must be keep out with the following conditions:
Inside
Moisture > 30%
Temperature between 1°C/ 33°F and 35°C/ 95°F.
Ø Transport: In the event of displacement of the device, please disconnect the cables, electrodes and USB.
Ø Disinfection’s:
Before each measurement session, the skin in contact with the electrodes is cleaned with alcohol and then dried in the air. Then the electrodes for feet and hands are cleaned using a bactericidal solution, fungicide and virucide without formaldehyde, then with alcohol and then dried in the air.
The examination is made with dry skin and dry electrodes.
Ø Maintenance and cleaning of the system will be made with the device disconnected from the computer (the green power supply led will be off).
- The electrodes must be cleaned with window cleaner at the end of the consultations, to restore their initial glare.
- The device will be cleaned with a computer cleaning material once per week
Incident: In the event of accidental contact with water or other liquids on the device, the electrodes or the cables, please disconnect the USB cable and contact the manufacturer
Technology or its distributor.
The EIS system is
Non-invasive
No operator dependant
No depend of the computer
Integrated model for the clinic and hospital
Background of the device
Physiology bases necessary for comprehension of the functioning of the device
The EIS device utilizes the technique of bioelectrical impedance
This technique is time-tested and consists in sending a current across the human body via tactile electrodes placed on two cutaneous points
According to the type of current and its frequency, this current circulates across different liquid compartments of the human body.
A current of 250 KHz or higher can traverse cellular and blood membranes and circulate across the bodily water which represents about 60% of bodily weight. (Thomasset, Nyboer)
A current of 50 KHz cannot traverse cellular membranes and therefore circulates only across the extra cellular liquids.
Further, the research of Kanai and Meijer showed that a direct current cannot traverse cellular and blood membranes and therefore circulates uniquely in the space between the cells and capillaries; this space is called the interstitial fluid.
The earliest and best known application of the technique of bioimpedance is the calculation of the fat mass by measuring the volume of total body water according to the formula including a coefficient, the size and the calculated resistance between the hands and feet: the volume is equal to a coefficient multiplied by the size squared divided by the measure of the resistance.
Nowadays as the technique has evolved into application of differing frequencies it is possible to determine the intracellular and extra cellular water, the muscular mass and the basal metabolic rate.
The EIS system utilizes this technique and proposes an analysis of body composition.
Last and most recent application: imagery by impedance. This technique utilizes the methods of mathematical calculation for reconstruction by direct and inverse problems. In 1999 the U.S. FDA validated the T-Scan in the screening of breast cancer and also for this methods of mathematical reconstruction.
The EIS system is using this methods of mathematical reconstruction
The specificity and the patent of the EIS system rely on utilizing direct current in bioelectrical impedance.
By this specificity the EIS system can only measure one compartment of the human body: the interstitial fluid.
Thus by utilizing direct current in bioelectrical impedance we have gained access to a rarely explored compartment that represents more than 16% of the human body; 4 times more than the vascular system.
The exploration of this compartment is quite interesting since unlike the bloodstream, the interstitial fluid is stagnant and remains in contact with the cell and the micro-circulation of the tissues.
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Therefore, by utilizing direct current and through application of the bio impedance technique and of the formula of body composition V = C Ht2/R, it is possible to calculate the interstitial fluid volume and from this, the sodium pool in this interstitial fluid.
The capillary pressure is determinate by the Hydrostatic and oncotic pressure balance between the interstitial fluid and the microcirculation.
Cells activity and ionic equilibrium
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Therefore, from the calculation of interstitial fluid volume and of the interstitial sodium pool, we have access to the following differing tissue and capillary parameters:
Mitochondria activity and ATP production
Oxygen consumption
Interstitial ionogram pool
Blood flow and viscosity
This image permits visualization of ATP production as a function of the escape of intracellular sodium towards the interstitial fluid.
For 3 ions of Na+ that leave the cell there is a compensation of two ions of K+ that enter into the cell. This entry of K+ is accompanied by the entry of H+ ions.
This study permits the visualization of the hypoxia provoked by the increase in volume of the interstitial fluid
The same study, show the relationship between the arterial pressure of oxygen and the metabolic acidosis and therefore the hypoxemia
Each compartment of the human body presents different concentrations of biochemical values.
There difference come from the Donnan equilibrium
The results of biochemical interstitial values and laboratory tests (blood) can be completely different for 2 reasons:
The interstitial fluid is stagnant
The measurement of the biochemical interstitial values represent the pool of the substance and not the concentration
How the EIS system has created the modeling of the human body and the localization of different organs and body systems?
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Direct problems:
Across six cutaneous tactile electrodes
2 on the forehead
2 on the palms of the hands
2 on the soles of the feet
The electronic device records 22 volumes of the human body (a volume is the space situated between 2 electrodes). The time of recording is one second per volume according to the following sequence.
A first localization of organs by direct problems came out through application of the mathematical calculation of Venn diagrams. However, this area of localization of different organs is not precise enough since several organs may be included in the same area.
The precision of localizing different organs requires the application of inverse problems and clinical tests for their resolution .
With the aim of creating inverse problems of localization we had to create a reference graph of conductivity measures of the 22 volumes recorded by the EIS system. This graph will serve as a reference and criterion of judgment for the clinical tests necessary for the elaboration of inverse problems.
This figure represents the average graph of EIS registration used on approximately 10,000 supposedly healthy persons (nearly equivalent in number of males and females and between 25 and 80 years.) We gave this graph the name Electro Scan Gram: ESG.
The values 1, 3, 9, 10, 16 and 18 from the forehead electrodes are on average inferior in conductivity because of the size of the smaller electrodes.
With the aid of the ESG graph as a reference and criterion of judgment, in order to establish algorithms of inverse problems of localization, different clinical trials were undertaken.
At the Gustave Roussy Institute (in oncology, France, 2002)
At the St. Louis Hospital (in andrology, France, 2003)
At the Botkin Hospital (a meta-analysis with 21 groups representing 20 groups of pathologies and 1 healthy group, Moscow, 2003)
At the Marfino Clinic (2 groups of patients in order to establish the correlation between results of biochemical and interstitial values on one hand and the validation with the aid of a reference device by calculating the fat mass (Moscow, 2004)
At the Botkin Hospital (for follow-up of therapeutic treatment concerning four pathologies (Moscow 2006)
At Dr. Caudal’s office (concerning ADHD, France, 2007)
We can visualize several examples of algorithms in cardiology
In Neurology
as well as certain digestive problems.
Some 700 algorithms of inverse problems were thus undertaken by a biostatistical study with specificity and sensitivity calculated, with a confidence interval of 95%.
It is not necessary to learn these algorithms as they are included in the EIS program and the great advantage of the computer is calculation much faster than the human brain.
The program of analyses of 700 algorithms of inverse and direct problems led on one hand to localization of different organs and therefore to the modeling of the human body and on the other hand to analysis of functional risk by system.
Process of modeling
1. Taking measurement
2. Mathematical calculation of direct problems with the aid of Venn diagrams
3. Creation of the ESG graph
4. Analysis of this graph with aid from Fourie Fast Transformation (FFT)
5 and 6. Entering information from 2 and 4 to the analysis program?
7. Analysis of results
8. Modeling
Chromatology and parameters
Organs are shown through chromatography from blue to red corresponding to the conductivity.
Dark blue corresponds to a very low conductivity, significant reduction of interstitial volume and an extremely reduced interstitial sodium pool.
Red corresponds to a maximal intensity of interstitial liquid, approximately 640µ, to an extremely increased interstitial volume and an extremely increased interstitial sodium pool.
These measures of conductivity have been converted according to a scale -100 to +100.
Based on the cellular respiratory physiology different parameters for tissues and blood have been attributed to each organ.
The color blue at the interstitial level indicates an increase of H+ pool (acid environment), potassium and chlorine pool and an increase of CO2.
There is hypoxemia and At the microcirculation level there is vasodilation and at the osseous level, reduction of the density. These parameters correspond to chronic inflammation.
Yellow or red at the interstitial level indicates an increase of sodium pool, with increased oxygen consumption and hypoxia, the bicarbonate pool is increased and heightened ATP production. There is a possibility of edemas, at the microcirculation level a vasoconstriction, at the brain level an increase of neuronal excitability , also possible pain and acute inflammation.
Measurement of the biochemical interstitial values
The chronoamperometry
Cottrell’s equation
The calculation of biochemical values is undertaken with the aid of Cottrell’s equation. This formula which has been used for 100 years has the advantage of linking the measure of intensity (i) with the concentration (Co). This method of calculating is used in numerous laboratory devices. The calculation of concentration requires a reference volume (v=CHt2/R) and a minimal recording of intensity during 3 seconds.
Results
Results are obtained through 3 consecutive measurements for a total registration time of under two minutes.
The first measurement is taken with alternating current of differing frequencies in order to determine the body composition.
The second measurement uses direct current (1 second per minute) permitting modeling
The third measurement uses direct current (3 seconds per volume) permitting calculation of the biochemical interstitial values.
With these 3 measurements EIS system gives access to seven types of results
1. Modeling: Results of parameters of tissues and microcirculation for each modelized organ. Modeling of the effects of the neurovegetative system, segmental muscular excitability modeling, spine modeling . Precision 96.5%
2. Statistical analysis of functional risks of systems by an external program (statistica version 7) with possibilities of dysfunctions expressed as a percentage in specificity and sensitivity.
3. Biochemical values (estimates)
4. Body composition: Precision 98%
5. Aid to therapeutic decision making: targeted supplementary examinations, nutrition and micro-nutrition, planttherapy, homeopathy, auricular acupuncture, somatic acupuncture
6. Follow-up.
In functional or alternative therapy.
In conventional, allopathic medicine.
In tests of effort or sports
Organs modeling example
Based on different parameters from measured cerebral tissues and from estimates of neurotransmitters the EIS system proposes a psychological analysis.
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Data from the level of the heart allow formulation of a very early therapeutic follow-up dealing with hypertension, arrhythmia, and the efficacy of antiagregant and/or anticoagulant therapies
Except in heart attack (in this case all these examinations are positives), each examination will be positive or negative in function of its specificity.
For example, you can have diagnoses of atherosclerosis with EB CT, and EIS negative, because EIS do not evaluating the diameter of the coronary, but the blood flow into the coronary.
And you can have diagnoses of atherosclerosis with EIS, and with the EB CT negative, because the problem is not the diameter of the coronary, but the high viscosity of the blood or thrombus into the coronary.
For the arterial blood pressure measurement, the EIS indicate the pressure of the vessels by mathematical calculation of the results of the microcirculation (starling equation).
At the level of the digestive system, data from the values of organs are important concerning dietary habits. Digestive organs in increased conductivity, yellow, need a reduction of acid foods and notably foods containing gluten for a period of one month.
Digestive organs in decreased conductivity, blue, need a reduction of alkaline foods and notably milk for a period of one month.
Results are visible after six weeks.
The EIS system modelizes the spine indicating zones of least mineralization (blue) and the zones of articular blockage and vertebral dislocation (yellow).
The EIS system also modelizes segmental innervation (dermatomes) permitting the localization of painful muscular zones (yellow) or zones presenting pain of somesthesia (blue).
The supplemental advantage that the EIS system proposes for chiropractors is the control of the action of the treatment by a new measurement after the treatment. This measurement, FCM, lasts 30 seconds and allows immediate visualization of the action and the possibility to change the treatment in case of error. The visualization allows understanding and mastering of this technique and rapid progression.
organic repercutions of the neurovegetative system modeling
Either an imbalance at the level of the sympathetic or parasympathetic system: Antagonist actions related to peristalsis at the colonic level. The EIS system allows visualization of their action on the modeling of the neurovegatitive system.
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The statistical analysis of functional risks is proposed for the following systems. This analysis is presented according to a scale of functional risks classed from I to IV, with risk I being the highest.
WARNING!
According to results obtained from parameters of tissues and blood and from algorithms from the ESG graph, based on clinical tests the external program (statistica) proposes possibilities of pathologies or dysfunctions for each system with a percentage of specificity and of sensitivity. These possibilities are not diagnosed; they allow only prescription of more specific or more sensitive targeted supplementary examinations.
All the data's from Statistical analysis of the patient’s risk are not available if the patient is under medications (drugs or chemotherapy, radiotherapy, surgery). In this case , The EIS system is not use for a screening of diseases but like a follow up of the effect of the therapies.
The interstitial biochemical values are different of the blood biochemical values and sometimes in opposite direction for 2 reasons
1. The interstitial biochemical values are more stable because the interstitial fluid is stagnant.
2. Unlike the blood biochemical value ,the interstitial biochemical values represent a pool of a substance and not a concentration
The EIS system establishes an estimate pool of different hormones at the level of the interstitial fluid.
This estimate has the advantage of being much more stable that the results at the blood level, which is a route of hormonal passage and a concentration and not a pool.
This estimate pool is made from the value of endocrine organs on the modeling ,the results of the ionogram and water composition (intra and extracellular water).
The therapeutic follow-up of doses of hormone treatment and notably the doses of thyroid substitute treatment is extremely precise with help from the EIS system. The follow-up comes about at the level of the hormonal schedule and equally at the level of the Davenport diagram.
Clinical trials at the Botkin Hospital in 2006 demonstrated the correspondence between measurement of TSH according to laboratory blood tests and measurement by the EIS system.
Interpretation of the results requires some physiology knowledge, in particular the chronobiology and the peak of production of the different hormones.
Cortisol:
With inflammation: The production of cortisol is increased. The production of cortisol reduces the ACTH production (feedback effect) and DHEA balance in cortico adrenal production)
Without inflammation: The peak is the morning (wake up), decrease until 11am, then increase until 4pm and then decrease.
Thyroid Hormones
The production of the thyroid is increased with the local temperature is too high and/or if you need to increase your metabolism (stress, effort, sport)
The production of thyroid hormone reduces the TSH production (feedback effect)
At normal body temperature condition, and without stress or effort:
The peak will be at 11am then decrease or stable related your activity.
Catecholamines
Increase with stress, and the production is related to your activity and lifestyle
Reduced catecholamine are related to the symptom of fatigue.
Sexual hormones
For women, related to their menstruation cycle
The production of oestradiol reduces the FSH production (biofeedback effect)
For the men, the level of testosterone is related to the brain activity. Good news increases the level of testosterone, and bad news, depression, inflammation reduces the level of testosterone
Insulin
Increases with food intake, in particular carbonic hydrate and sugars.
Decreases if you do not eat.
The level of aldosterone is increased in metabolic acidosis
The level of ADH is increased if there is dehydratation.
The level of PTH hormone is related to the calcemia levels.
The results of the EIS ionogram are calculated at the interstitial level by application of Cottrell equation and are presented in a graphic form according to a scale and a value in international units.
The EIS ionograms indicate the pool of the different ions and it should be more stable that the blood ionogram.
Interstitial values interpretation
Phosphates:
Increase: Possibility of: Hypoparathyroidism, Hypovitaminose D, Pancreatitis Hypomagnesaemia, Diarrhoea, Tetania, Cutaneous affections
Decrease: Hyperparathyroidism, Bone affections, Osteolysis, Hypervitaminose D
Potassium:
Decrease Possibility of: Hyper insulinaemia Hyperthyroidism, Interstitial nephropathy Hypercorticism associed with hypertension (Hyperaldosteronism)
Increase: Possibility of: Hypocorticoadrenal, hypoaldosteronism Diabetes keto acidosis Hypoinsulinism Muscular troubles Fibrillation, conduction troubles
Drugs linked with hyper kaliaemia: Diuretic, B-blockers, Inhibitor of Angiotensinogenic enzyme, Antibiotics, Corticoids, Glucose, insulin or potassium perfusion
Calcium:
Decrease Possibility of: Hypoparathyroidism, Hypovitaminose D, Pancreatitis Hyperphosphataemia, Hypomagnesaemia, Diarrhoea, Tetania
Lower ventricular contraction Cutaneous affections
Increase: Hyperparathyroidism, Bone affections, Osteolysis, Constipation, Nauseas Hypervitaminose D
Magnesium:
Decrease: Possibility of: Intestinal malabsorption, Diarrhoeas, Hyperaldosteronism Hyperthyroid, Hypoparathyroidism, Pancreatitis
The oxidative stress is estimated in function of the importance of different free radicals. The derivatives of nitrogen (ONOOH, NO and OH- ions) and the derivatives of oxygen (O2 and H2O2). This diagram permits the follow-up of antioxidant treatments.
It is notable that entropy is accelerated by oxygenated derivatives. Selenium will reduce these free radicals
Nitrogen derivatives can provoke damage at the level of ADN: Manganese will reduce these free radicals.
The EIS system is the only device to propose an evaluation of neurotransmitters at the cerebral level:
The calculation is made by the chronoamperometry method (Cottrell equation) in a scale -60/+60 with reference norms range from -20 to +20 (red lines).
Estimate of serotonin: estimate from clinical trials at Botkin Hospital 2003 and 2006. Symptom: depression.
Estimate of dopamine: estimate from clinical trials on ADHD 2007. Symptoms: addictive behavior, aggressiveness, hyperactivity
Estimate of catecholamine: estimate from clinical trials at St. Louis Hospital 2003. Symptom: stress
Estimate of Acetylcholine: estimate from the activity of the parasympathetic system
Interstitial cerebral Serotonin:
Decreased => Depression, emotional disorders
Increased=> Insomnia, behaviour disorders
Interstitial cerebral Dopamine
Increased => addiction, hyperactivity, lack of concentration, aggressively
Decreased=> lack of communication, lassitude, lack of vitality
Interstitial cerebral Catecholamines
Increased => memory disorders, stress
Decreased=> lack of concentration, lack of vitality, fatigue
Interstitial cerebral Acetylcholine
Increased => Cranial parasympathetic increased and effects on the cardiac rate
frequency (tachycardia)
Decreased=> Cranial parasympathetic decreased and effects on the cardiac rate
frequency (bradycardia)
The Davenport diagram exists for 60 years; it was created by Davenport with the goal of defining the acid-basal equilibrium at the level of arterial blood. However, it is rarely used in medicine outside of its use with analyses of gas from the blood done in hospital settings for sampling arterial blood when diagnosing major respiratory pathologies and renal insufficiency.
The EIS system has adapted this diagram by considering the measures no longer at the level of arterial blood but at the level of interstitial fluid. The absence of buffers at the level of interstitial fluid makes this diagram perfectly usable in working out pathologies and dysfunctions, and also for therapeutic follow-up.
The acid-basal equilibrium is thus expressed at the level of no buffering compartment and there are three types of acidosis or alkalosis:
Metabolic acidosis or alkalosis under the dependence at the level of bicarbonates. This level is determined by the horizontal line SBE and the blue dotted lines called Bic.
Respiratory acidosis or alkalosis under the dependence of PCO2. This level is determined by a vertical line passing by the value of 46 mm of Hg (at the interstitial level, the pressure of CO2 is higher.)
The acidosis or alkalosis in the interstitial fluid, visualized by the slanting line graded between 7.0 and 7.7. The normal pH of interstitial fluid is 7.33 (more acid than the arterial pH: 7.4 ).
Following study of cases resulting from clinical trials, and also from seven years of utilization of the system in different countries of the world, we have established the 22 zones that Davenport defined for his diagram as the possibilities of pathologies. It is important to note that these possibilities are specific to over 89% outside of any allopathic treatment. Allopathic treatments have a tendency to inverse this diagram. Thus, chemotherapeutic treatment displaces the cancer zone to the zone of cardiovascular maladies and the treatment of cardiovascular maladies moves the zone of cardiovascular maladies into the zone of cancer.
On the right of the diagram: Respiratory alkalosis we have the zone of theHypothyroidism
These results are not available to making a diagnosis, because they have very high specificity but not low sensibility.
Information’s concerning the body composition are important in the domain of sport and also equally to judge one’s lifestyle, problems of obesity, follow-up in diabetes type II, and cardiovascular pathologies.
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The nutritional and micro nutrition program analysis (according to mathematical calculation of Venn diagram) uses the totality of these parameters to establish a quickly personalized nutrition which can be printed and handed to the patient.
Clinical application of the EIS in your daily practice
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Each examination presents its specificity of exploration and of claims. The diagnosis of the same organ may require several exams and for the same organ certain exams may be positive or negative according to their specificity.
In neurology the EIS system occupies an important place because it is the lone device capable of measuring the cerebral neurotransmitters and from this to issue an objective and non-symptomatic diagnosis of ADHD (see the study of Caudal), unipolar and bipolar depression (IRB and investigation in progress at the MacLean Hospital, Pr. Stoll Boston, MA)
Concerning the heart, the EIS system presents the specificity to measure oxygenation and microcirculation at the level of cardiac tissue.
Except in heart attack (in this case all these examinations are positives), each examination will be positive or negative in function of its specificity.
For example, you can have diagnoses of atherosclerosis with EB CT, and EIS negative, because EIS do not evaluating the diameter of the coronary, but the blood flow into the coronary.
And you can have diagnoses of atherosclerosis with EIS, and with the EB CT negative, because the problem is not the diameter of the coronary, but the high viscosity of the blood or thrombus into the coronary.
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Some examples of therapeutic follow up
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Examen de départ: Alcalose respiratoire sévère TSH mesurée au laboratoire: 9
Mise en place d’un traitement de substitution 80 µg et contrôle après 6 semaines
Before treatment: Severe respiratory alkalosis, TSH measured in laboratory: 9.
Start of a substitution treatment of 80 µg and control after six weeks.
The patient is still in respiratory alkalosis with a symptom of chronic fatigue and has no cardiovascular risk. The dosage is insufficient.
Following a change of dosage (120 µg) controlled after six weeks: the patient has no more symptoms; however the dosage is too high (for respiratory acidosis) and increases the cardiovascular risk so a new dosage is proposed 100 µg.
Result after six weeks: the dosage is satisfactory.
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The Davenport diagram enables controlling the efficacy of the treatment.
Following chemotherapy, passage into metabolic alkalosis is a sign of efficacy.
A chemotherapy that does not bring about a passage to metabolic alkalosis after one week shows an ineffective protocol. A change of protocol is necessary.
However, if this metabolic alkalosis is too severe, it contra-indicates a new appointment due to the extreme cardiovascular risk.
Following a cardiovascular event, passage to metabolic acidosis is a sign of efficacy.
A cardiovascular treatment that does not bring about a passage to metabolic acidosis after three weeks shows an ineffective protocol. A change of treatment is necessary and may be a surgery
However, in case of severe metabolic acidosis it is imperative to reduce the dosages because the side effects may be too severe, notably fatigue and hepatic disorders.
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It is known that Nux vomica acts exclusively at the level of stomach function. Liver values remain unchanged.
Effect of Nux vomica at the level of the right frontal lobe: increase in neuronal excitability
Action at the digestive and respiratory levels.
Contribution of proteins increases the functioning of all organs of the digestive system..
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Congratulation, You have finish your level 1 training . Thank you for your time . Now, You will use the EIS system in your daily practice and will discover by VISUALIZATION the effects of different therapeutic which you practice.
Each one will use the EIS system differently according to his specialty and you will adapt it in its practice.
You will be surprised and you will learn a little more every day. Each individual being unique, you will evolve according to your patients and will practice a personalized medicine. The system will bring you rationality, the co-operation of the patients and especially an organization of follow-up and an appreciable saving of time.
You are now suited to pass your certification with a quiz via Internet: Connect to the site: www.ldteck.com
