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Abstract: Arm simulator is a device for simulating behavior of the arm for testing and calibrating a noninvasive blood pressure meter. It can also be used as an instrument aid in teaching the healthcare professionals to correctly use a blood pressure meter. The objective of the project is to design and build a low cost artificial arm for BP measurement using Koroktoff sound as well as Ossilometric method. For generating Koroktoff sound or pressure pulses in arm, 8 bit PIC microcontroller is used. Theses sounds or pulses are generated based on the BP parameters set through an external control panel, and in response to time varying pressure under the cuff as dynamically sensed by a pressure sensor. Korotkoff sound is generated using a digital-to-analog convertor (DAC). In the first stage of the project, microcontroller based simulator circuit is bread-boarded and a program has been written which can be used for setting the values of systolic pressure, diastolic pressure, heart rate, arrhythmia, and pulse volume within their respective pre-specified ranges.
1. Introduction
Measurement of blood pressure (BP) is the most commonly used tool for assessing a patients cardiovascular system. It gives certain important information about patients abnormal blood pressure such as hypertension (high blood pressure) and hypotension (low blood pressure). Abnormal blood pressure is also known as a silent killer, because the condition generally does not have any symptoms. Therefore it is very important to regularly monitor the blood pressure. For accurate reading of blood pressure, the measuring instrument should be tested and calibrated. Testing of blood pressure instrument is very difficult with living subject because pressure level may become different at different times. Also, pressure reading varies depending upon the certain physiological factor such as sleep, body position, smoking, emotional state, etc. Taking multiple readings of the same subject to test the precision of the instrument or for comparing readings from two instruments may leads to change in the BP value. Hence, this method of calibration is tedious, time consuming, and unreliable. The purpose of this project is to develop a low cost microcontroller based arm simulator which
can be used for simulating blood pressure reading over full clinical range along with different types and rates of heart beat.
point at which sound is heard known as the systolic pressure. This sound arises because the blood flow is converted from laminar to turbulent form. The pressure below the sounds disappear is the diastolic pressure. this sound arises because blood flow is converted into turbulent form to laminar form. When the pressure is below the systolic pressure, but above the diastolic pressure, a clear tapping sound is heard with the heart beat. The sounds are heard in five phase- (i) initial 'tapping' sound (cuff pressure = systolic pressure), (ii) sounds increase in intensity, (iii) sounds at maximum intensity, (iv) sounds become muffled, and (v) sounds disappear. This technique does not require any expense. However, it cannot be used in noisy environment. In this technique mechanical error can get introduced e.g. mercury leakage, air leakage, obstruction in the cuff etc. It does not give accurate results for infants and hypotensive patients.
Fig. 3.2 Auscultation method for indirect blood pressure measurement [3]
(ii) Oscillometric Method
The ossilometric method works on the same principle as the auscultator method but it does not use stethoscope as shown in Fig. 3.3. When the cuff pressure is in between the systolic and diastolic pressure, each cardiac cycle causes a small change in the cuff pressure, which has the appearance of oscillations. These oscillations, caused by the blood flow in artery below the cuff, are sensed using a pressure transducer. The appearance and end of the oscillation indicate the time at which the cuff pressure shows the systolic and diastolic pressure. The readings are not affected by high environment noise such as emergency and clinical room. The method can be used to reliably measure the mean arterial pressure. In this
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method, excessive movement of patient or vibration during measurement may result in inaccurate reading.
(a)
(b) Fig. 3.3 Oscillometric method of blood pressure measurement (a) Cuff placement (b) Oscillation in cuff pressure [3] Fig. 3.3 (b) shows that oscillation in cuff pressure. The point of maximum oscillation corresponds to the mean arterial pressure. The point at which oscillation begins to increase rapidly is known as the systolic pressure and the mean arterial pressure at which oscillation is decreasing rapidly is known as the diastolic pressure.
(iii) Tonometry Method As shown in Fig.3.4, this method uses a flat plate to compress the surface of the skin directly over a superficial artery, supported from below by a bone (radial artery). An arterial rider, cylindrical in shape, senses the radial stress of the artery by means of a sensor array. Effect of skin tension in vertical direction is set to zero by the side plate. The arterial rider strain gauge sensor detects the arterial pulsation. For estimating pressure, force is divided by contact area of arterial rider. This method is non-invasive and non-painful and can be used to monitor blood pressure continuously. It has relatively high cost and the wrist movement of patient may
gives inaccurate reading.
(iv) Ultrasonic Method (Doppler method) Doppler sensor is used to detect motion of the blood vessel to determine blood pressure as shown in Fig. 3.5. A compression cuff is placed over the arm with 8 MHz transmitting and receiving crystals [4]. Ultrasound source transmits signal on the blood vessel and the reflected signal is transduced by the receiving crystal, and then amplified. The reception of reflected signal indicates the closing and opening of artery. Frequency difference between transmitted and reflected signal is proportional to the blood velocity and velocity of wall motion. For the cuff pressure between diastolic and below systolic pressure, the blood vessels open and close with each heart beat, because artery pressure oscillates between cuff external pressure. As the cuff pressure further increases, the time between opening and closing artery
Fig. 3.5 Ultrasonic method for indirect blood pressure measurement [4] decreases until they coincide. The reading at point is known as the systolic pressure. The cuff pressure futther decreases, the time between opening and closing artery increases until they coincide. The reading at point is known as the diastolic pressure. This method can be used in noisy environment and it can be used with infant and hypotensive subject. Movement by the patients change the alignment between the sensor and vessel thus the reflected signal does not give correct reading. 4. Blood pressure simulator A BP simulators is used to test and calibrate the BP monitor by assessing the repeatability and stability. In clinical environment, simulators are used as part of the quality assurance in for quick testing of BP monitors [8]. Two basic type of simulator have been developed, limb simulator and waveform simulator as shown in Fig. 4.1. A limb simulator models the artificial limb (arm). Waveform simulator generates pressure waveforms. Arm simulator is in the form of inner cylinder filled with water and K-sounds are generated by transducer. An outer layer of water is in flexible form that transmits the sound waves to pressure cuff and transducer. A waveform simulator generates Ossilometric waveform, which is fed into the cuff tubing of the tested monitor. The most commercial available simulators are BP Pump 2 and Cufflink by Fluke Biomedical, SmartArm and AccuPulse by Clinical Dynamics, QA1290 by Metron and SimCube SC-1 by Pronk Technologies. The simulators suffer from a
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number of disadvantages such as, large size, lack of flexibility in settings. Hence for the measurement of blood pressure under different cardiovascular condition, a compact portable BP simulator is needed.
4.1 Calibration
Accuracy of blood pressure measurements is dependent upon the deflation rate. For calibrating any instrument, pressure gauge reading is compared with a standard mercury sphygmomanometer and T connector is used between gauge and instrument. Any offset error if found should be corrected. For finding how much offset is needed, apply the cuff to the simulated arm. Set the simulator systolic pressure to 150 mmHg and set the diastolic pressure to 70 mmHg. Proceed with a simulated blood pressure measurement. Note the difference between the gauge and the simulator reading. Example, if the blood pressure reading was taken and the sound started at 148 mmHg, and then the offset is +2 mm. If the sound started at 152 mmHg, the offset is 2. For diastolic pressure if sound stopped at 72 mmHg, the offset is 2 or if the sound stopped at 68 mmHg, the offset is +2. [10]
Fig. 4.1 Two basic types of simulator for testing of BP measurement (a) limb simulator, (b) waveform simulator [8].
electrical signal. This monitor contains the amplitudes of detected pulses and stores them along with corresponding value of cuff pressure. This data is then reviewed and the pressure level at which maximum pulse amplitude has occurred is determined. The cuff pressure is also applied on both side of a diaphragm located in pulse chamber. The cuff pressure is further applied on pressure transmitter of the simulator which converts it into electrical signal. This signal is then given to both procceser and control circuit which control the valve opening and closing. Output of the processer is fed to electrical pulse generator which produces pulses at selected rate and varying amplitude depending upon the cuff pressure created by monitor. In this way, blood pressure reading is simulated. When processer activates pulse geneartor, it supplies pulse signal to valve control circuit for closing the valve. Processor always gets current value of cuff pressure along with preset value of systoic, diastolic, and mean atrial pressure, then it computes the required pulse amplitude according to the line equation. Pulse rate genearted is determined by the set heart rate.
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5. Design approach
In the block diagram as shown in Fig. 5.1 the microcontroller is the central control unit of the simulator. For a very compact design, the microcontroller should have sufficient programmable ROM, data RAM, parallel I/O ports, UART, and a programmable timer/counter for handling all the operations without requiring additional chips. Arm simulator will be in the form of a cylinder. The cuff containing the transducer is placed surrounding the cylinder and the transducer kept between cuff and cylinder converts pressure variations to voltage. The voltage corresponding to the pressure variation is given as input to the amplitude calculator, which also takes as input the following parameters systolic pressure (SP), diastolic pressure (DP), and the mean atrial pressure (MAP). These parameters are input through a keypad. The entire scheme can be implemented using microcontroller with on chip ADC and DAC. The pressure variations are given as input to the ADC of the microcontroller. The program converts these pressure variations into varying amplitude pulses which is converted to sound using an appropriate audio module.
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Pressure sensor
DAC out
Keypad
LCD
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Port Pin PA.1 PA.4 PA.5 PA.6 PA.7 PB.1 PB.2 PC.4 PC.5 PC.6 PC.7
Function LCD data pins Enable of LCD RS of LCD RW of LCD Square wave Non periodic pulse Increment key Decrement key Left key Right key
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C2 = 0.1 F PIC16F1936 8 VSS U2 VPP 19 VSS VDD 11 PC.0 PB.0 12 PC.1 PB.1 13 PC.2 PB.2 14 PC.3 PB.3 9 PA.7 PB.4 10 PA.6 PB.5 7 PA.5 PB.6 6 PA.4 PB.7 5 PA.3 PC.7 3 PC.6 PA.1 4 PC.5 PA.2 2 PC.4 PA.0
5V
JHD 162A
LCD DISPLAY
NC NC
1 20 21 22 23 24 25 26 27 28 18 17 16 15 NC NC NC NC NC NC NC NC R3 R4 R5 R6 S4 S3 S2 S1 GND
GND
NC NC
5V R2 330 R7 10 k
R3 = R4 = R5 = R6 = 10 k
10 k
GND
GND
5.3 Software
The functioning of keys and LCD display are controlled by software. The simulator has two modes of operation: (i) Definition mode (ii) Operating mode. In definition mode all the keys are active and we can select and change all the five parameters. The user can select or change the mode and parameters following the algorithm as given below. 1. Start. 2. Default operation mode is definition mode; user can go to operation mode by pressing key1 or 3. 3. Check for key press. 4. In definition mode all the parameters can be incremented or decremented by pressing key 1 or 3. 5. In operating mode, key 1 and 3 will not work and it generates non periodic pulse wave according to heart beat. Check for key press.
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6. If key is pressed then do work accordingly. If left or right key is pressed then select the parameter, go to step 3. If up or down key is pressed then increment or decrement selected parameter respectively, go to step 3. 7. Display current setting on LCD for the user. 8. Go to step 3.
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` Appendix: BP simulator
1. No 600 blood pressure simulator Arm [15] - This arm uses Auscultation method for measuring blood pressure. It also simulates the palpation of the radial pulse, and varies systolic and diastolic pressures from 0300 mm HG in two mm increments, variable amplitude of sound heard, sound jack for group listening, auscultatory gap setting, and heart rate settings. 2. (i) BPT-001 Blood Pressure Simulator [16] - This Blood Pressure Simulator simulates the five Korotkoff phases. It cost is 795$.It also provides the following features Systolic and diastolic settings On or off of ausculatory gap Adjust volume Adjust pulse rate (ii) BPK3-001 Blood Pressure Training Arm - This arm designed for training the procedure of NIBP measurement with an electronic trainer. Its cost is 940$. It also provides the following features Palpable antecubital pulse Blood Pressure Trainer with LCD guided operation Systolic, diastolic, heart rate, and auscultatory gap are programmable. Representation of both systolic and diastolic pressures Indication of gauge reading as pressure is increased or decreased Adjustable volume 3. NASCO Life/form Blood Pressure Simulator (lf03204) [11] - The NASCO Life/form Blood Pressure simulator is programmed to demonstrate the 5 Korotkoff phases, including an auscultatory gap, which can be heard during auscultation of a subject, while measuring the subjects blood pressure. This simulator digitally records the pressure sound by varied pulse rate and volume. It also provides the following features Calibration of simulator Setting of palpation Extra speaker to hear korotkoff sound
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Setting of systolic pressure, diastolic pressure, pulse rate, and pulse volume. 4. SimCube NIBP Simulators [13] - Simcube NIBP Simulators are compact, handheld, affordable and easy to use. It simulates real-life oscillometric pulses by varying both the size and shape of the wave as cuff pressure changes. It also provides the following features It provides NIBP Simulations for Adult, Neonatal, hypertensive, and hypotensive subject. Digital Manometer 12-lead ECG: 10 different Heart Rates, synchronized with NIBP Respiration: 3 rates, plus a sequence of 7 different rates Pacer Simulation Peak Detect- For checking overpressure limits in 0.5 mmHg steps Leak Test Mode- It measures leak rate of a NIBP monitor, cuff, and hose Automated Alarm Test Mode- Tests heart rate alarms 5. Non-Invasive Blood Pressure Simulator (Rigel 311c) - It uses ossilometric waveforms for accurate calibration of NIBP monitors. It provides graphic representation of the inflation and deflation process. It displayed/ measured following parameters dynamic NIMP cuff pressure waveform, measurement time ( in seconds), maximum inflation Pressure (in mmHg typical), inflation time, inflation Rate (mmHg/sec), minimum Pressure, deflation time, deflation Rate. It also provides the following features It provides NIBP Simulations for Adult, Neonatal Digital Manometer, Leak Test 6. Non-Invasive Blood Pressure Simulators (1000 series) [13] - The Model NIBP-1000 Series is a family of Microprocessor based, High Precision Non-Invasive Blood Pressure (NIBP) Simulators. The units are small, easy to use and have multiple features to fit many different applications. The NIBP-1020, offers ECG waveforms that are full QRS and respiration waveforms that look real. The NIBP-1030 offers Invasive Blood Pressure, Temperature, Arrhythmias and a Leak Rate test mode. The graphics display not only provides multiple screens that give the pressure digitally in mmHg, but also offers views of the plot of the overall pressure or a close-up of the BP waveform. This model comes in different series with more features. The following are highlights of some of the main features NIBP(1010) Large graphics display with cursor selection of options and setup of parameters Full range manometer
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Adult, neonatal, hypertensive and hypotensive modes Digital pressure envelope offset Optional peak pressure detect with simple reset Digital calibration no pots to turn Flash programmable NIBP(1020)- It provide all the basic model features plus: Ecg output with full nsr waveform Sinusoidal respiration simulation Ecg test waveforms Pace waveform Optional peak pressure detect with ecg alarm test Ecg syncronized with blood pressure NIBP (1030) - It has all the 1020 model features plus Synchronized invasive blood pressure output Static Invasive blood pressure simulation Leak rate test Ecg arrhythmia waveforms Ecg arrhythmia sequence
7. Cufflink Noninvasive blood pressure analyzer [10] - This Analyzer uses oscillometric
method for simulation and generate BP waveforms for seven adult, five neonate, and 5 arrhythmias. The different systolic/diastolic pressure gradients simulate a physiological range of normal, hypotensive, and hypertensive adult or neonate patients. An internal pump pressurizes the NIBP system under test. Use the Analyzers digital manometer instead of a mercury column for doing pressure measurements. The Analyzer facilitates overpressure testing of NIBP monitors by automatically detecting and displaying the overpressure point. The Analyzer has the following standard features: Dynamic oscillometric noninvasive blood pressure simulation Automated static pressure measurements, leakage testing, and relief-valve testing Five automated NIBP testing autosequences Five arrhythmia selections Adult and neonatal NIBP selections Adjustable heart rate values
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8. BP Pump 2 Non-Invasive Blood Pressure Simulator and tester [10] - This simulator include multi-purpose test instrument for use with oscillometric Non-Invasive Blood Pressure Monitors (NIBPMs). The Tester provides dynamic blood pressure simulations, static calibration, automated leak testing, and pressure relief valve testing. The following models are available: (i) BP Pump 2L (Basic Model) (ii) BP Pump 2M (High-Accuracy Model) The model has the following key features Pressure leak testing on cuff, tubing, and connections Relief valve testing on the patient monitor Pressure gauge measurements Pressure source capability NIBP simulations including adult, neonate, arrhythmias, and respiratory artifacts Auto sequences with optional reports Internal Adult and Neonatal Cuff simulation ECG synchronization with non-invasive output External wrist cuff simulations
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References
[1] K. Sembulingam and P. Sembulingam, Cardiovascular system, Essential of Medial Physiology, 5th ed., New Delhi: Jaypee, 2010, pp. 500-504. [2] C. Guyton, Physics of blood, blood flow, and pressure: Hemodynamics, Textbook of Medical Physiology, 7th ed., Philadelphia: saunders, 1986, pp. 206-209. [3] Handbook of Biomedical Instrumentation, 2nd ed., Tata McGraw Hill, New Delhi, 2009, pp. 218-227. [4] J. G. Webster,Blood pressure and sound, Medical Instrumentation Application and Design, 2nd ed., Boston, USA: Houghton Mifflin company, 1992, pp. 394-401. [5] J. J. Carr and J. M. Brown, Physiological pressure and other cardiovascular measurement, Introduction to Biomedical Equipment Technology, 4th ed., Delhi: Pearson Education, 2001, pp.234-245. [6] W.Glover and R. Medero,Arm Simulator for an Ossilometric blood pressure monitor, U.S. Patent 4,464,123, August 7, 1984. [7] K. Ruiter and W. W. Ruiter,Compact Ossilometric blood pressure simulator, U.S. Patent apl. 20100076713, 30 June, 2008. [8] G.Gersak, A. Zemva, and J. Drnovsek. (2009, October) A procedure for evaluation of non-invasive blood pressure simulators. Med Biol. Eng Comp.[online].47(12), pp.12211228,Available: http://www.springerlink.com/content/351052r33660n551/fulltext.pdf. [9] F. Leo and Jr. Costello,Ossilometric Noninvasive Blood Pressure Simulator, U.S. Patent 5,027, 641, July 2, 1991. [10] Fluke Biomedical, Cufflink NIBP analyzer Available online : http://assets.fluke.com.cn/evtmanuals/bppump2_omeng0000.pdf. [11] Nasco Life/form, LF03204U blood pressure simulator, Available online: http://www.enasco.com/pdfs/lf03204.pdf.
[12] Clinical Dynamics , AccuPulse NIBP Simulator Available online:
http://www.clinicaldynamics.com/pdfs/NIBP/AccuPulseSpecSheet.pdf. [13] Pronk Technologies Inc., Sim cube NIBP simulator, Available online: http://www.pronktech.com/simcube-nibp-simulator-pronk.htm. [14] Rigel medical, BP-SIM Handheld NIBP Simulator Available online: http://www.rigelmedical.com/products/nibp_simulators.asp. [15] Simulaids, No 600 Blood Pressure Simulator Arm Available online: http://www.simulaids.com/PDF/BloodPressureSimulatorArm.pdf.
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[16] Pinnacle technology group, BPT-001 Blood Pressure Simulator Available online: http://www.pinnacletec.com/pdf/pinnacle_catalog.pdf.
U3 LM7805
1 IN R2 100K 1 R2 2 0 0hm R2 10K C10 100uF C11 0.1uF OUT 3
D5V
U4 LM1117
3 IN Vout Vout
2 4
D3V3
GND
C12 0.1uF
C13 100uF
GND
C14 0.1uF
C15 100uF
CON3 J3
BAT U5 LM7805
1 IN OUT A5V 3 3
DGND
U6 LM1117
IN Vout
A3V3
1 2 CON3 J3 R2 0 ohm
GND
1 GND
C16 100uF
C17 0.1uF
C19 100uF
C20 0.1uF
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