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Medicine scientific center of I CONFIRM

rehabilitation MARFINO ( Russia) Manager of scientific program


121099 Моscou, novi Arbat Street , N°.32 medical doctor
Dr Rasnikin S.M.

05. 01 2005.

COMPARATIVE STUDY OF THERAPY FOLLOW-UP


USING THE CONVENTIONAL METHODS AND DDFAO/
ESG SYSTEM

FINAL REPORT
According to the clinical protocol of investigation (PICMFN)
Of 12.06.2004
Center of investigation
MEDICINE SCIENTIFIC CENTER OF
REHABILITATION MARFINO

Promotor or sponsor
MASTER MEDIA represented by M.MEDVEDEV Sergei

Clinical investigator coordinator


Dr. RASNIKIN S.M.
Manager of the scientific program,
Medical doctor

Monitor
Dr. MARASANOV A.
Medical doctor
Presentation of the DDFAO
DDFAO /ESG System makes it possible to measure:

- Electroscangram corresponding to measurements of conductivity of 22 body volumes whose


graphic interpretation was possible within the application of the algorithms exits of the clinical
tests carried out to Botkin Hoptal (Moscow).
- Acid base balance (interstitial pH ) and interstitial gases (PCO2, PO2, ).
- Interstitial ionogramme.
- Body composition

Thus, it positioning like a physiopathological system of investigation.

Design features of the device:

Functioning Speed (per second) 50 000


Tension of the electrodes, in operating mode 1,28 V
Intensity maximal 200µA
Speed transmission 12 Mbd
Galvanic decoupling of the analogical part, 2,5 Kv
Dimensions in mm 128 X 143 X 33
Weight kg 1,2

Principle and structure of the device

The device is composed of a USB circuit and a circuit of converters placed on the same chart and
separated by a galvanic decoupling.
This chart is installed in a black box.

The black box included:


- 1 green LED of control of PC / black box recognition.
- 1 yellow LED of control of PC/ black box recognition.
- 1 green LED of control of the power supply
- 4 RCA connectors "HEAD" "HAND" "FOOT" "TEST".
- port USB-A...

The system included:

-A black box, cables , reusable metal electrodes for the feet and the hands and single use
electrodes for the face
- Instructions of the system
- European cerficat EC 0459 of the 15.11.2002.
- The certificate of the Health ministery of Russian MS RF n°2003/990 of the 07.07.2003.

2
PROTOCOLE OF THE CLINICAL TESTS
Conformity or modifications of the clinical plan of investigation (PICMFN) of
12.06.2004
No modification of the device was made during the investigation.
The investigation followed in a way in conformity the clinical protocol of investigation
(PICMFN).
No side effect was recorded following the recordings.
After agreement of the ethical committee on 22.06.2004 , the clinical investigation began the
07.07.2004, in the respect of the declaration of Helsinki.

Confidentiality
The confidentiality was respected by all the parts implied throughout the clinical investigation.
All the data are protected and inaccessible to the unauthorized parts.

The confidentiality of information relative on each subject as with its private life will be
preserved in the reports/ratios and any publication of the data of the clinical investigation.
The reports/ratios will include/understand a patient code that program ESG generates
automatically according to the sex, of the name, the first name and the day of the date of birth.

During the time of the 07 07. 2004 to the 20.08.2004 , 33 patients with various pathologies
underwent a cure of rehabilitation in the Medecine scientific center of rehabilitation Marfino.
The therapeutic follow-up of these patients was evaluated according to 2 processes :

1. Conventional examinations
Anamnesis and Blood Analysis ( venous and capillary ):
The anamnesis retained the main risk and the associated risks.

The blood assessment:

Total Atherogen Urea Triglycerides Glyceamia Prothrombin


Cholesterol quotient
ASAT Amylases Gamma Creatinin Uric Acid Calceamia
GT
Magneseamia Natreamia Kalieamia Iron lymphocytes Bilirubin

Analysis of the body composition with the AVITA BF 1 ( impedance device).

2. Recordings using DDFAO system.


The recordings have were carried out at the beginning of treatment, then at one week and at the
end of the treatment.

We recorded 33 patients including 16 Men and 17 women . The average age being 41 years.
This assessment was carried out at the beginning of the treatment (07.07.2004) and at the end of
the treatment (20.08.2004)

3
Results

1. Main risk of the patients and risks analysis DDFAO system

Name/codes Age Diagnosis risks analysis DDFAO


Main risk
1BA05 38 Metabolic Syndrom digestive
2ZV09 56 Angina pectoris Hypertension cardiovascular
2ZT04 Metabolic Syndrom cardiovascular
1KV10 69 Angina pectoris cardiovascular
2KU14 17 Metabolic Syndrom digestive
2LV07 46 Hypertension scale1 . cardiovascular
2MN15 57 Hypertension scale 2 . cardiovasculair
1MA04 Metabolic Syndrom Neuromuscular
2MR24 Hypertension scale 2 cardiovascular
2MN06 57 Osteochondrosis Neuromuscular
1NA06 57 Hypertension scale 2 cardiovascular
2OI25 41 Chronic Gastroduodenitis digestive
2PG25 58 Osteochondrose HTscale 1 cardiovascular
2RI01 50 Metabolic Syndrom digestive
1RS11 Metabolic Syndrom digestive
2RN13 44 Hypertension scale 2 cardiovascular
1RU19 44 Osteochondrosis Neuromuscular
1SM24 44 Osteochondrosis Neuromuscular
2SI05 Metabolic Syndrom digestive
1SA29 42 Hypertension scale 1 cardiovascular
2SI23 39 Peptic Ulcer. digestive
1TV07 48 Angina pectoris cardiovascular
1UP12 Metabolic Syndrom cardiovascular
1FA14 53 Angina pectoris cardiovasculair
1CV11 57 Osteochondrosis Neuromuscular
2CI31 57 Veinous disorder cardiovascular
1SV10 32 Hypertension scale 2 cardiovascular
2SN15 Osteochondrosis Neuromuscular
2SE28 54 Metabolic Syndrom digestive
2JN25 43 Cervical arthrosis Neuromuscular
2VG02 59 Hypertension Atherosclerosis. cardiovascular
2DE20 46 Cervical Osteochondrosis Neuromuscular
2KM02 69 Ostéochondrosis Neuromuscular

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2. Follow-up of the risk by DDFAO system

Cardiovascular risk
Name Visit 1 Visit 2 Visit 3
2ZV09 21 21 21
1KV10 60 60 21
2LV07 50 21 21
2MN15 21 21 21
2MR24 21 21 21
2RN13 21 21 21
1SA29 21 21 21
1TV07 21 21 21
1FA14 21 21 21
2SN15 21 21 21
2VG02 50 21 21
328 270 231

Сердечно-сосудистые заболевания
Evolution of the cardiovascular risk

35

30

25

20

15

10

0
1 2 3

5
DIGESTIVE SYSTEM
Patients visit 1 visit 2 visit 3
2BN06 60 21 60
2BE21 60 21 60
1BA05 60 21 60
2CI31 21 60 60
2DE04 0 0 0
2DI03 0 0 0
2DE20 60 60 21
2DL03 0 21 21
1FA14 60 60 60
1IM18 60 60 21
2JN25 0 21 0
1KV10 21 21 60
2LL22 60 21 0
2LI17 60 60 60
2LV07 21 21 60
2MN15 60 60 60
1MA04 0 60 21
2MR24 60 60 21
2MD23 60 21 21
2MG20 60 60 60
2MT02 21 60 60
2MN06 60 60 21
1NY05 60 60 60
2OI25 0 0 60
1PS20 21 60 0
2PG25 60 60 21
1RU19 0 21 21
2RN13 60 60 60
1SM24 21 21 60
2SN15 21 21 21
1SV10 21 60 21
1SA29 60 60 60
1SA03 21 21 21
1TV07 60 21 60
2VG02 0 21 21
2ZV09 60 60 60
36,92 38,75 37,58

Система пищеварения
Digestive risks
39,00
38,50
38,00
37,50
37,00
36,50
36,00
35,50
1 62 3
URO GENITAL SYSTEM
Patients visit 1 visit 2 visit 3
2BN06 0 0 0
2BE21 0 21 21
1BA05 21 21 21
2CI31 21 21 21
2DE04 0 0 0
2DI03 0 0 0
2DE20 0 21 0
2DL03 0 60 21
1FA14 21 21 21
1IM18 0 21 0
2JN25 0 0 0
1KV10 21 21 21
2LL22 0 21 21
2LI17 21 21 0
2LV07 21 21 21
2MN15 0 0 0
1MA04 0 21 21
2MR24 0 21 60
2MD23 21 21 21
2MG20 21 21 21
2MT02 21 21 21
2MN06 21 21 21
1NY05 21 21 21
2OI25 0 0 0
1PS20 21 21 0
2PG25 21 0 60
1RU19 0 21 21
2RN13 21 21 21
1SM24 21 21 21
2SN15 21 21 21
1SV10 21 21 21
1SA29 0 21 21
1SA03 21 21 21
1TV07 21 21 21
2VG02 0 60 60
2ZV09 21 21 21
11,67 19,08 18,42

Мочеполовая
uro genital система
System

30,00
20,00
10,00
0,00
1 2 3

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OSSEOUS DISEASE
Patients visit 1 visit 2 visit 3
2BN06 21 0 21
2BE21 0 21 21
1BA05 21 21 21
2CI31 21 21 21
2DE04 0 0 0
2DI03 0 0 60
2DE20 21 21 21
2DL03 0 21 21
1FA14 21 21 21
1IM18 21 21 0
2JN25 0 0 0
1KV10 21 21 21
2LL22 0 60 60
2LI17 21 21 21
2LV07 21 60 21
2MN15 0 0 0
1MA04 0 21 60
2MR24 0 21 21
2MD23 21 21 60
2MG20 21 21 21
2MT02 21 21 21
2MN06 21 21 21
1NY05 21 21 21
2OI25 0 0 21
1PS20 60 21 0
2PG25 21 0 21
1RU19 0 21 21
2RN13 21 21 21
1SM24 21 21 21
2SN15 60 21 60
1SV10 21 21 21
1SA29 0 21 21
1SA03 21 21 21
1TV07 0 60 21
2VG02 0 21 21
2ZV09 21 21 21
15,00 20,17 23,50

Костные заболевания
Osseous disease

30,00
20,00
10,00
0,00
1 2 3

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ENDOCRINE DYSFUNCTION
Patients visit 1 visit 2 visit 3
2BN06 0 0 21
2BE21 0 60 21
1BA05 21 60 21
2CI31 0 21 21
2DE04 21 60 21
2DI03 21 21 0
2DE20 0 21 0
2DL03 0 21 21
1FA14 21 21 21
1IM18 0 21 0
2JN25 21 0 21
1KV10 21 21 21
2LL22 0 21 21
2LI17 21 0 0
2LV07 21 21 21
2MN15 21 21 21
1MA04 0 21 0
2MR24 21 21 21
2MD23 21 21 21
2MG20 0 21 21
2MT02 21 21 21
2MN06 0 0 0
1NY05 21 21 21
2OI25 21 0 21
1PS20 21 21 21
2PG25 21 21 21
1RU19 21 21 21
2RN13 21 21 21
1SM24 21 21 21
2SN15 0 21 21
1SV10 60 21 60
1SA29 21 21 21
1SA03 60 60 60
1TV07 21 0 21
2VG02 21 21 21
2ZV09 21 21 21
16,75 21,83 19,67

Эндокринные заболевания
Endocrine dysfunction
25,00
20,00
15,00
10,00
5,00
0,00
1 2 3

9
OXIDATIVE STRESS
Patients visit 1 visit 2 visit 3
2BN06 0 21 0
2BE21 21 21 21
1BA05 21 21 21
2CI31 21 21 21
2DE04 21 21 21
2DI03 0 0 21
2DE20 21 21 0
2DL03 21 21 21
1FA14 21 21 21
1IM18 21 21 21
2JN25 0 21 0
1KV10 21 21 21
2LL22 21 21 21
2LI17 21 21 21
2LV07 21 21 21
2MN15 21 21 21
1MA04 21 21 21
2MR24 21 21 21
2MD23 21 21 21
2MG20 21 21 21
2MT02 21 21 21
2MN06 21 21 21
1NY05 21 21 21
2OI25 21 21 21
1PS20 21 21 21
2PG25 21 21 21
1RU19 21 21 21
2RN13 21 21 21
1SM24 21 21 21
2SN15 21 21 21
1SV10 21 21 21
1SA29 21 21 21
1SA03 21 21 0
1TV07 21 21 21
2VG02 0 21 21
18,67 20,42 18,67

Дерматологические заболевания
Oxidative stress

15,00
14,50
14,00
13,50
13,00
12,50
1 2 3
10
Underlying situation
Patients visit 1 visit 2 visit 3
2BN06 0 0 0
2BE21 21 21 21
1BA05 21 21 21
2CI31 21 21 21
2DE04 0 0 0
2DI03 0 0 0
2DE20 0 21 21
2DL03 0 21 21
1FA14 21 21 21
1IM18 21 21 0
2JN25 0 0 0
1KV10 21 21 21
2LL22 0 21 21
2LI17 21 21 21
2LV07 21 21 21
2MN15 21 21 21
1MA04 0 21 21
2MR24 21 21 21
2MD23 21 0 0
2MG20 21 21 21
2MT02 21 21 21
2MN06 21 21 21
1NY05 21 21 21
2OI25 21 0 21
1PS20 0 21 0
2PG25 21 21 21
1RU19 21 21 21
2RN13 21 21 21
1SM24 21 21 21
2SN15 0 21 0
1SV10 21 21 21
1SA29 0 21 21
1SA03 21 21 21
14,00 17,50 16,33

Совокупность свойств организма


Underlying situation
20,00

15,00

10,00

5,00

0,00
1 2 3

11
3.Correspondence of the values of the blood ionogramme and DDFAO
biochemical estimation

KALIEAMIA
Patients A.sanguine 1 DDFAO 1 A.sanguine 2 DDFAO 2
1BA05 N N
2ZV09 -5 N
2ZT04 +5 N
1KV10 -5 -5
2KU14 N N
2LV07 3,5 N 4,1 N
2MN15 3,3 -5 6,1 +5
1MA04 N N
2MR24 5,7 +5 5,7 +5
2MN06 3,2 -10 -10
1NA06 3,4 -5 -5
2OI25 4,9 +5 4,9 +5
2PG25 2,9 -10 4,1 N
2RI01 N N
1RS11 -5 -5
2RN13 4,3 +5 +5
1RU19 5,1 +5 2,6 -5
1SM24 3,9 N 3,9 N
2SI05 N N
1SA29 4,3 +5 2,8 -5
2SI23 5 +5 4,3 N
1TV07 5 +5 5 +5
1UP12 +5 +5
1FA14 3,4 N 2,2 -10
1CV11 4,6 +5 +5
2CI31 3,4 -5 3,7 -5
1SV10 4,2 +5 3,7 N
2SN15 3 -5 2,7 -10
2SE28 +5 +5
2JN25 2,9 -10 6,2 +5
2VG02 3,8 N 5,1 N
2DE20 4,3 +5 4,8 +5
2KM02 4,6 +5 2,5 -5
0,00 0,00 0,00

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NATREAMIA
Patients A.sanguine 1 DDFAO 1 A.sanguine 2 DDFAO 2
1BA05 N N
2ZV09 N N
2ZT04 N N
1KV10 N N
2KU14 N N
2LV07 155 +5 141 N
2MN15 127 -5 132 N
1MA04 N N
2MR24 142 +5 134 N
2MN06 138 N 104 -10
1NA06 137 N N
2OI25 149 +5 139 N
2PG25 110 -10 131 N
2RI01 N N
1RS11 N N
2RN13 163 +10 N
1RU19 129 N 138 N
1SM24 118 -10 86 -10
2SI05 N N
1SA29 148 N 138 N
2SI23 140 N 139 N
1TV07 120 -5 N
1UP12 N N
1FA14 165 +10 132 N
1CV11 137 N N
2CI31 135 N 138 N
1SV10 126 N 129 N
2SN15 156 +5 135 N
2SE28 N N
2JN25 166 +10 146 N
2VG02 188 +10 +10
2DE20 137 N 130 N
2KM02 117 -5 138 N
0,00 0,00

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CALCEAMIA
Patients A.sanguine 1 DDFAO 1 A.sanguine 2 DDFAO 2
1BA05 -5 -5
2ZV09 N N
2ZT04 N N
1KV10 N N
2KU14 N N
2LV07 1,15 -5 1,74 -5
2MN15 2,23 N 1,84 -5
1MA04 N N
2MR24 2,27 N 2,13 N
2MN06 1,37 -5 1,43 -5
1NA06 1,39 -5 -5
2OI25 1,88 -5 1,88 -5
2PG25 2,28 N 2,22 N
2RI01 -5 -5
1RS11 N N
2RN13 2,45 N N
1RU19 2,06 N 2,06 N
1SM24 0,89 -10 1,75 -5
2SI05 N N
1SA29 1,71 -5 1,89 -5
2SI23 1,78 -5 1,57 -5
1TV07 1,14 -5 1,92 N
1UP12 N N
1FA14 1,99 N 2,02 N
1CV11 1,77 -5 -5
2CI31 1,73 -5 1,97 -5
1SV10 1,25 -5 1,66 -5
2SN15 1,6 -5 1,5 -5
2SE28 N N
2JN25 1,62 -5 1,94 N
2VG02 1,75 N 2,25 N
2DE20 1,83 N 3,29 +5
2KM02 1,79 -5 1,55 -5
0,00 0,00 0,00

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MAGNESEAMIA
Patients A.sanguine 1 DDFAO 1 A.sanguine 2 DDFAO 2
1BA05 N N
2ZV09 N N
2ZT04 N N
1KV10 N N
2KU14 N N
2LV07 0,8 N 0,77 N
2MN15 0,48 -5 1,01 N
1MA04 N N
2MR24 0,73 N 0,51 N
2MN06 0,63 N 0,68 N
1NA06 0,86 N N
2OI25 0,61 N 0,61 N
2PG25 0,8 N 0,91 N
2RI01 N N
1RS11 N N
2RN13 0,77 N N
1RU19 0,84 N 0,6 N
1SM24 0,82 N 1,51 +5
2SI05 N N
1SA29 0,84 N 0,8 N
2SI23 0,81 N 0,74 N
1TV07 0,58 -5 0,97 N
1UP12 N N
1FA14 0,49 -5 1,09 N
1CV11 0,31 -5 -5
2CI31 0,21 -10 1,15 N
1SV10 0,64 N 0,79 N
2SN15 0,22 -10 0,96 N
2SE28 N N
2JN25 0,37 -5 0,89 N
2VG02 0,82 N 0,69 N
2DE20 0,71 N 0,9 N
2KM02 0,4 -5 0,85 N

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4. Correspondence of the values of the percentage of fatty mass, masses thin and
total water using system AVITA BF 1 BODY FAT ANALYZER and system DDFAO

Patients MM Kg Eau Kg MG% MM Kg Eau Kg MG%


1BA05
2ZV09 49,7 36,4 38 50,49 34,69 38,8
2ZT04
1KV10 70,9 50,3 23,1 70,88 49,99 23,55
2KU14 40,2 29,4 16,7 40,18 27,54 16,03
2LV07 49,3 36,1 39,8 47,12 34,08 40,22
2MN15 50,8 37,2 31,4 51,06 34,2 33,16
1MA04
2MR24 50,2 36,8 31,2 51,47 33,85 32,24
2MN06 45,5 33,3 38 42,75 30,94 39,63
1NA06 62,2 45,5 25,9 69,22 48,95 29,5
2OI25 42,7 31,1 24,6 39,77 27,24 23,23
2PG25 45,1 33 42,3 47,12 34,18 42,98
2RI01 49,8 36,4 34,7 49,58 33,45 35,02
1RS11
2RN13 54,8 40,1 38,8 54,45 38,29 37,96
1RU19 70,3 51,5 27 65,9 47,45 27,64
1SM24 61,1 44,7 25,7 60,2 43 25,96
2SI05
1SA29 70,9 50,1 26,9 68,46 48,06 25,74
2SI23 53,9 39,5 33,3 56,5 37,65 32,25
1TV07 61,6 45,1 22,1 66,44 46,5 21,72
1UP12

1FA14 61.7 45,1 29,55 61,5 44,46 31,27


1CV11 64,5 40,2 20,3 57,06 39,29 20,79
2CI31 52,1 38,2 30,5 42,57 29,09 26,19
1SV10 74,4 55 29,7 73,26 54,36 29,2
2SN15 48,6 32,6 21,9 48,58 31,67 21,27
2SE28
2JN25 45,4 36,1 29,1 44,55 30,25 27,29
2VG02 47,1 30,8 38,1 47,6 32,19 36,98
2DE20 44,7 32,7 35,8 46,62 32,81 35,78
2KM02 56,6 56,4 47,4 55,61 40,26 47,55

16
Conclusions
The tests carried out on 33 patients in double control as well by the conventional methods as by
DDFAO system, make it possible to conclude with the reliability of the system which gives
results of estimate of the risk, biochemical constants and body composition in conformity has
more than 89%.
In the base of recorded patients, the use of the DDFAO made it possible to note that the risk
increases during the first week, and to decrease appreciably at the end of the cure.
By its ease of use, its non-invasive and the speed of obtaining the results (3 minutes),
DDFAO system naturally finds its place in the regulation of supplementary examinations, the
estimate of the body composition and the therapeutic follow-up

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Address participants :
Dr Rasnikin S.M.
Manager of the scientific program,
Medical doctor.
Medecine scientific Center of rehabilitation MARFINO
121099 Моscow, novi Arbat Street , N°.32 Russia

Dr Marasanov V .A
Medical doctor
121099 Моscow, novi Arbat Street , N°.32 Russia

Analysis laboratory of the Medecine scientific Center of rehabilitation MARFINO


121099 Моscou, novi Arbat Street , N°.32 Russie

Material used for the body composition


AVITA BF 1 BODY FAT ANALYZER

MASTER MEDIA
represented by its general manager M.Medvedev Sergei: data-processing engineer
Moscou Hlebnikov per ,7-2 , Russie

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