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CARDIOLOGY ECG – basic information
ČVUT, March 2010Jan Daněk, BTL
Cardiology, ECG, ČVUT, March 20102
BTL Holdings Limitedwww.btlnet.com
BTL Zdravotnická technika a.s.www.btl.cz
Medical Technologies CZ a.s.vývojové centrum BTL
1992 – založení, obor fyzioterapie, česká společnost1997 – obor kardiologie1998 – expanze do zahraničí2005 – obor estetická medicína2009 – CZ, RO, PL, BG, SK, UK, KZ, IT, IN, PT, CY, GB, US
O společnosti BTL BT
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Cardiology, ECG, ČVUT, March 20103
BTL 2010 ve světě BT
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Cardiology, ECG, ČVUT, March 20104
BTL 2010 v Čechách
V České republice:
vývojové oddělení (50 kolegů)
výroba elektroniky a prototypových sérií (35)
zahraniční obchod (18)
domácí obchod pro ČR (35)
servisní oddělení pro ČR a okolní státy (4)
Každý rok uvést nejméně dva / tři nové produktyna světový trh – představení na světové výstavěMEDICA Düsseldorf (www.medica.de).
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Cardiology, ECG, ČVUT, March 20105
Kardiologie
1997 – počítačové EKG
1998 – spolupráce s firmou Aspel, PL
2001 – 1. vlastní přímopíšicí EKG
2004 – kompletní řada EKG
2006 – začátek spolupráce s firmou Spacelabs
2008 – SW BTL-08 MEW „kardiologické pracoviště“
2009 – SW BTL-08 MEW Spiro
budoucnost? –> být nejlepší!
Schiller Swiss, General Electric, Philips (býv. HP)
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Cardiology, ECG, ČVUT, March 20106
Vývoj zdravotnické techniky
Mezinárodní řada norem IEC (www.iec.ch):
IEC 60601-1 (základní norma o bezpečnosti)
IEC 60601-1-2 (EMC, EMI)
IEC 60601-2-25 (EKG bezpečnost)
IEC 60601-2-47 (EKG Holtery)
IEC 60601-2-51 (EKG parametry)
v ČR zastoupen ÚNMZ (www.unmz.cz)
Certifikace v CB systému (www.iecee.org):
v ČR zastoupen EZÚ Praha (www.ezu.cz)
CE značka, FDA schválení, systém jakosti ISO
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Cardiology, ECG, ČVUT, March 20107
EKG – bezpečnost
Tzv. příložná část typu CF, odolná defibrilaci:
unikající proud do pacienta max. 10 µA (NC)
pomocný proud pacientem max. 10 µA (NC)
unikající proud do pacienta max. 50 µA (SFC)
pomocný proud pacientem max. 50 µA (SFC)
NC – Normal Condition, SFC – Single Fault Condition
Pro napájecí napětí 250 Vac:
Rizol > 25 MΩ
Cparasit < 127 pF
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Cardiology, ECG, ČVUT, March 20108
Electrocardiogram - history
It is a record of the electrical activity of the heart over time.
Alexander Muirhead, St Bartholomew's Hospital, London
1st record of the patient’s heartbeat, 1872
Augustus Waller, St Mary's Hospital, Paddington, London
1st electrocardiograph machine, 1887
ECG signal was projected to a wall
Willem Einthoven, Leiden, The Netherlands
1st clinically used machine, 1901 – 1903
signal was recorded on a moving roll of photographic paper
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Cardiology, ECG, ČVUT, March 20109
Willem Einthoven – early ECG device
• 1st machine weighted 600 lb / 270 kg and required strong water cooling for powerful electromagnets
• he assigned the letter P, Q, R, S and T to the deflections of the ECG signal
• Nobel Prize 1924 CA
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Cardiology, ECG, ČVUT, March 201010
ECG signal & heart
Detail description: http://en.wikipedia.org/wiki/Ecg#Waves_and_intervals
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Cardiology, ECG, ČVUT, March 201011
Electrocardiogram – lead systems
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Chest 6
Chest 5
Chest 4
Chest 3
Chest 2
Chest 1
Right Leg
Left Leg
Left Arm
Right Arm
Brown/VioletV6White/VioletC6
Brown/OrangeV5White/BlackC5
Brown/BlueV4White/BrownC4
Brown/GreenV3White/GreenC3
Brown/YellowV2White/YellowC2
Brown/RedV1White/RedC1
GreenRLBlackN
RedLLGreenF
BlackLAYellowL
WhiteRARedR
CODE 2 / USCODE 1 / EU
Cardiology, ECG, ČVUT, March 201012
Electrocardiogram – lead systems
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Standard ECG 12-lead system is the group of the3 systems:
Einthoven bipolar extremity leads – I, II, III
Goldberger unipolar extremity leads – aVR, aVL, aVF
Wilson unipolar chest leads – V1, V2, V3, V4, V5, V6
10 electrodes (9 active / 1 neutral)
(R L F C1 C2 C3 C4 C5 C6 / N)
12 leads
(I II III aVR aVL aVF V1 V2 V3 V4 V5 V6)
Cardiology, ECG, ČVUT, March 201013
Electrocardiogram – lead systems
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V6 = C6 – (L + R + F) / 3V6
V5 = C5 – (L + R + F) / 3V5
V4 = C4 – (L + R + F) / 3V4
V3 = C3 – (L + R + F) / 3V3
V2 = C2 – (L + R + F) / 3V2
V1 = C1 – (L + R + F) / 3V1
aVF = F – (L + R) / 2aVF
aVL = L – (R + F) / 2aVL
aVR = R – (L + F) / 2aVR
III = F – LIII
II = F – RII
I = L – RI
ELECTRODESLEADS
Cardiology, ECG, ČVUT, March 201014
Electrocardiogram – Einthoven lead system
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Cardiology, ECG, ČVUT, March 201015
Electrocardiogram – Goldberger lead system
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Cardiology, ECG, ČVUT, March 201016
Electrocardiogram – Wilson lead system
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Cardiology, ECG, ČVUT, March 201017
Electrocardiogram – Wilson lead system
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Cardiology, ECG, ČVUT, March 201018
Electrocardiogram – lead systems
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Cardiology, ECG, ČVUT, March 201019
Electrocardiogram – Cabrera lead system
IIIaVF
aVFaVL
IIaVR
- aVRIII
III
aVLI
CABRERASTANDARD
The Cabrera leads order makes it easier to visualize waveform progression in the frontal plane.
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Cardiology, ECG, ČVUT, March 201020
Electrocardiogram – FRANK lead system
8 electrodes 3 leads
Vx = 0.610 A + 0.171 C – 0.781 I
Vy = 0.655 F + 0.345 M – 1.000 H
Vz = 0.133 A + 0.736 M – 0.264 I– 0.374 E – 0.231 C
Frank lead system is not supported
by ECG diagnostic (Glasgow, BTL).
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Cardiology, ECG, ČVUT, March 201021
Electrocardiogram – BTL lead system
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V6 = C6 – (L + R + F) / 3V6
(L + R + F) / 3 = “NOISE” = – N
V5 = C5 – (L + R + F) / 3V5
V4 = C4 – (L + R + F) / 3V4
V3 = C3 – (L + R + F) / 3V3
V2 = C2 – (L + R + F) / 3V2
V1 = C1 – (L + R + F) / 3V1
aVF = F – (L + R) / 2 aVF = (II + III) / 2aVF
aVL = L – (R + F) / 2 aVL = (I – III) / 2aVL
aVR = R – (L + F) / 2 aVR = (III – 2*II) / 2aVR
III = F – LIII
II = F – RII
I = L – R I = II – IIII
ELECTRODESLEADS
Cardiology, ECG, ČVUT, March 201022
Electrocardiograph – BTL lead system
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The output meets with requirements of IEC 60601-2-51:2003.
Cardiology, ECG, ČVUT, March 201023
BTL lead system – practical results
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Extremity electrode R – wrong contact
I, II, aVR, aVL, aVF leads disappear (III – distorted)
Extremity electrode L – wrong contact
I, III, aVR, aVL, aVF leads disappear (II – distorted)
Extremity electrode F – wrong contact
all extremity leads disappear
other leads can be distorted
Extremity electrode N – wrong contact
all leads disappear or are distorted
Chest electrode Cx – wrong contact
only chest lead Vx disappear
other leads are not affected
Cardiology, ECG, ČVUT, March 201024
How to reduce noise – 1st possibility
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Connect extremity electrodes close to patient body:
It is used mainly for ergometry investigation to reduce extremity muscles artifacts.
Cardiology, ECG, ČVUT, March 201025
Calculation of the heart’s electrical axis
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The heart's electrical axis is usually oriented in a right shoulder to left leg direction, although -30° to +90° is considered to be normal.
BTL ECGInternal Design
ČVUT, March 2009Jan Daněk, BTL
Cardiology, ECG, ČVUT, March 201027
Electrocardiograph – BTL lead system
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The output meets with requirements of IEC 60601-2-51:2003.
Cardiology, ECG, ČVUT, March 201028
ECG – inputs connection
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Cardiology, ECG, ČVUT, March 201029
ECG – defibrillator protection
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1st stage – implemented in the ECG cable
2nd stage – on the Analog board in the ECG machine(1st components on the input)
maximal energy of the pulse could be 500 J
Cardiology, ECG, ČVUT, March 201030
ECG – input impedance
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Resistor R300 define “ground” potential.
Used amplifier is type J-FET with high impedance input.
Final input impedance ≈ 330MΩ || 220pF
Cardiology, ECG, ČVUT, March 201031
ECG – input radio filter
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1st stage – good ECG cable
2nd stage – low pass filter, band width 12 kHz(without any influence on the ECG signal)
Cardiology, ECG, ČVUT, March 201032
ECG – amplifier
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1st stage – differential amp. – gain 10, bandwidth 1.59 kHz
2nd stage – gain 22.4, band width 339 Hz, 2nd order(without any influence on the ECG signal)
Cardiology, ECG, ČVUT, March 201033
ECG – amplifier 1st differential stage
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Used resistors have accuracy 0.1%.
Used capacitor are linear with accuracy 5%.It guarantees perfect removing of the common signal.
Cardiology, ECG, ČVUT, March 201034
ECG – high pass filter
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High pass filter, according IEC 60601-2-51.
1st order, bandwidth 0.05Hz (3.2 sec)
Used capacitors is linear foil type, accuracy 5%.
Cardiology, ECG, ČVUT, March 201035
ECG – high pass filter / restart circuit
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Activated when you press button RESTART.
Fast discharging of high pass filter.
Cardiology, ECG, ČVUT, March 201036
ECG – amplifier 2nd stage / low pass filter
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Low pass filter, bandwidth 339Hz, 2nd order.
It is last filter in front of A/D converter, reduce signal above1000Hz (sample frequency is 2000Hz).
Cardiology, ECG, ČVUT, March 201037
ECG amplifier – frequency response
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Final frequency response, include response of the ADC and basic digital filters meets requirements of IEC 60601-2-51.
Cardiology, ECG, ČVUT, March 201038
ECG amplifier – phase response
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All used filters are designed with the respectto have linear phase response –to do not change time parameters of the ECG signal.
Cardiology, ECG, ČVUT, March 201039
Cardiology, ECG, ČVUT, March 201040
ECG – neutral electrode
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Calculation of neutral signal – accuracy resistor 0.1%.
Cardiology, ECG, ČVUT, March 201041
ECG – neutral electrode
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Calculation of neutral signal – accuracy resistor 0.1%.
Compensation of ECG cable.
Cardiology, ECG, ČVUT, March 201042
ECG – neutral electrode
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Calculation of neutral signal – accuracy resistor 0.1%.
Compensation of ECG cable.
Defibrillator protection.
Cardiology, ECG, ČVUT, March 201043
ECG cable – active shielding
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To reduce influence of ECG cable on the ECG signal.
Signal of Neutral Electrode is connected to shielding.
Cardiology, ECG, ČVUT, March 201044
Detection of disconnected leads – how works
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1st stage – measuring of DC offset of each lead
2nd stage – amplitude of 50Hz (60Hz) noise signal(it is possible to change the level of the detection)
Cardiology, ECG, ČVUT, March 201045
Pacemaker detection
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Bandwidth gate – 159 Hz>> derivative + integrative element – 47 µs
>> negative part – integrative element 10 ms>> comparator
Cardiology, ECG, ČVUT, March 201046
A/D converter
15-bits, 1 kHz / lead, 8 inputs, sensitivity 3.9 µV
Power Filtration:
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Cardiology, ECG, ČVUT, March 201047
ECG block scheme
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Insulation 4kV, creepage distance 8mm.
Insulation 1.5kV, creepage distance 4mm.
Battery24V (2x12V)
Steppermotor
Touch-Panel+
LCD
Main MicroprocessorWatch-Dog
Supply SupervisorRAM & ROM Memory
Drivers for LCD Drivers for LEDSound generator
Power supply for processor board
1,9V; 3,3V; 5V; 21VPower supply for CFL
073-51SHCPUxxxCPU BOARD
PatientIntput
Supply SupervisorMicroprocessorProgram MemoryData Memory
ADCMonitoring CirciutsProtection CircuitsInterference Filter
Power & Communication line
070-51ANALOGxxxMEASURE INPUT BOARD
P1
P2
S1
S2
Pulse
powe
rsup
ply
MainsFilter
MainsFilter
RS232in/out
USBin/out
32V
Battery charger28V/1A
073-51POWERxxxPOWER SUPPLY BOARD
POJ3external fuse folder
Mains inlet
Main switch
Main transformerTR2
F2
F200
F1
2n2/250V
BTL ECGImplemented filters
ČVUT, March 2009Jan Daněk, BTL
Cardiology, ECG, ČVUT, March 201049
ECG Filters – 0.07-80Hz adaptive
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Cardiology, ECG, ČVUT, March 201050
ECG Filters – 0.07-80Hz adaptive
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The “adaptive” filter was developed according requirements of users
they want to have ECG signal without distortion of QRST complex (amplitude + time parameters)
they want to have smooth curve between QRST complexes (mainly with respect to time parameters)
Similar problem solved by HP / Philips, GE, Schiller
solution – adaptive filter which change parameters according ECG signal
QRST – almost without filtration
T-P-Q – strong filtration
Cardiology, ECG, ČVUT, March 201051
ECG Filters – 0.07-80Hz adaptive
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The 0.07-80Hz adaptive filter is combination of these filters:
muscle adaptive filter
mains 50 / 60 Hz adaptive filter
baseline spline filter (ADS cubic).
Muscle adaptive filter:
detects of the dynamic changes of the signal (QRS)
according its chooses between 5 low pass filters
typical bandwidth is 80 Hz
Cardiology, ECG, ČVUT, March 201052
ECG Filters – 0.07-80Hz adaptive
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Practical example:
original ECG signal signal for the control function
Cardiology, ECG, ČVUT, March 201053
ECG Filters – 0.07-80Hz adaptive
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Final filtration (momentary bandwidth):
88Hz90Hz
18Hz
13Hz
12Hz
20Hz
18Hz
Cardiology, ECG, ČVUT, March 201054
ECG Filters – 50/60Hz adaptive
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It is designed as sinus software oscillator which works like phase-loop circuit
searches harmonic mains frequencies in the ECG signal in the range 45 to 65 Hz
when the signal is found starts to subtract the found signal from the original
for quick response is good to set correct starting condition – 50 Hz <> 60 Hz
It has no affect on the ECG signal because it removesjust one – mains frequency –no damage frequency spectrum.
Cardiology, ECG, ČVUT, March 201055
It works with 10 sec strips of ECG signal
looks for “null” points in ECG signal in the middle between P and Q wave(the part with smallest change in the time)
insets a curve in the “null” points
subtract the curve from original ECG signal
The filter use special type of “spline hermit function”.
This type of filter used first GE.
ECG Filters – baseline spline filters
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Cardiology, ECG, ČVUT, March 201056
The name of spine filter (cubic – 3rd, square – 2nd, linear –1st order of function) says which curve will be used for connection of the nearby “null” points.
ECG Filters – baseline spline filters
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Cardiology, ECG, ČVUT, March 201057
ECG Filters – baseline filters ADS 0.05 – 1.5 Hz
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It is a linear simulation of the basic 1st order high pass filter designed in hardware variant by RC elements
linear characteristics (frequency, phase)
but small filtration power
0.05Hz (3.20sec) & 0.10Hz (1.50sec)small influents on the signal
0.25Hz (0.60sec)influents on ST segments
0.50Hz (0.30sec) & 1.50Hz (0.10sec)use just for rhythm measurement (ergometry)damage QRS amplitude, ST segments...
Cardiology, ECG, ČVUT, March 201058
ECG Filters – baseline filters ADS 0.05 – 1.5 Hz
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no damage ECG signal
Cardiology, ECG, ČVUT, March 201059
ECG Filters – muscular filters
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The muscular filters removes high frequencies from the ECG signal
35Hz – acceptable affect on the QRS complex
25Hz – just for rhythm measurements
Cardiology, ECG, ČVUT, March 201060
ECG Filters – muscular filters
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BTL ECGProcessing of ECG signal
ČVUT, March 2009Jan Daněk, BTL
Cardiology, ECG, ČVUT, March 201062
ECG signal processing
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Setting of the user’s filters has no effecton the measuring and diagnostic interpretation.
Cardiology, ECG, ČVUT, March 201063
Beat Computing
CO
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UT
ING
Cardiology, ECG, ČVUT, March 201064
Typical ECG record
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3 pages A5, print format 6x2+1 + interpretation
Cardiology, ECG, ČVUT, March 201066
Competitors
Cardiology:
Schiller, www.schiller.ch
Philips, www.medical.philips.com
General Electric, www.gehealthcare.com
Mortara, www.mortara.com
Physiotherapy:
Enraf-Nonius, www.enraf-nonius.com
Gymna-Uniphy, www.gymna-uniphy.com
Chattanooga, www.chattanoogagroup.com
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Cardiology, ECG, ČVUT, March 201067
Další výborné české firmy
LINET, www.linet.comsvětový výrobce nemocničních postelí
EGO, www.egozlin.czmobilní nemocnice
Beznoska, www.beznoska.comkloubní náhrady
BMT, www.bmt.czvybavení operačních sálů, sterilizace...
Cheirón, www.cheiron.czdýchací zařízení a odsávačky krve
BTL, www.btlnet.com ...a další viz www.medica.de
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Cardiology, ECG, ČVUT, March 201068
Used literature and sources
http://www.wikipedia.com
http://en.wikipedia.org/wiki/Ecg
http://www.btlnet.com
Jan Havlík, Czech Technical University at Prague.
International Standard IEC 60601-2-51:2003.
Malmivuo, J. – Plonsey, R: Bioelectromagnetism. Oxford University Press, New York, 1995.
BTL marketing and production materials.
GE marketing materials.
PHILIPS / HP marketing materials.
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Cardiology, ECG, ČVUT, March 201069
Contact information
Medical Technologies CZ a.s.
Jan Daněk
Development Department
Radimova 36
169 00 Praha 6
Czech Republic
tel. +420 602 163 525
fax +420 270 001 699
www.btlnet.com, www.btl.cz, www.medictech.com
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Thank you very muchfor your attention.
ČVUT, March 2009Jan Daněk, [email protected]