INFORMATION SOCIETY TECHNOLOGIES (IST) PROGRAME

Contract for:

TRIAL

Annex 1-"Description of Work"

Project acronym: CARDIOSMART Project full title: Intelligent Cardiology Monitoring System using GPS/GPRS Networks Proposal/Contract no.: IST-2001-35073 Related to other Contract no.:

1. Project Summary 1.1 Objectives The main design and realisation of a novel intelligent and portable electrocardiograph device with a GPRS link for monitoring the heart activity of patients and the automatic detection and transmission of fundamental heart failures. This general objective will be achieved by means of the following detailed objectives: A) Design of the portable electrocardiograph prototype. This design will be done according to the concept defined by a patent owned by CARDIOTEST. It must maximise its autonomy, real-time processing power capability and robustness. It must be also user-friendly, as a patient maybe in critical situation will use it. B) Selection of algorithms for cardiac disease detection, compression and cryptography to optimise the amount of data transmission. C) Integration of the device in an already existent Cardiac Monitoring System (CAMS). D) Industrial version of the terminal will be commercialised by CARDIOTEST. E) Technology transfer from AICIA to CARDIOTEST. 1.2. Description of the work The project is organised in several tasks as follows: 1)Portable Electrocardiograph Design. This task includes the design of the system architecture and its partitioning in several subsystems: - Signal Conditioning Module, which will adapt cardiac signals.

- Signal Processing Module, which includes cardiac signal preprocessing, pattern recognition, compression and cryptography. - Communication Module, including transmission and GSM Voice links. GPRS data

- GPS Module, to determine the exact location of the patient. - Power Module, to maximise power savings to provide maximum autonomy. Special care must be taken in the interaction of the subsystems and Hardware&Software integration 2)System Prototyping. Physical realisation of the previous subsystems. 3)System Integration. Interconnection of previous subsystems. Special care must be taken with the power consumption and electromagnetic interference between the Signal Conditioning and Communication Modules. 4)System testing and validation. Local centre test will be used to validate design performance according to already proven routines and tests. It will include fieldtesting, where the prototypes will be evaluated in Cardiotest medical centre, and performance checked. 5) Dissemination of the results. The experiment expertise gained will be disseminated by contributions in relevant international congresses and journals and generation of media material. All this work will be based on previous research carried out by CARDIOTEST and AICIA, which have already

generated a first version of an on-line portable electrocardiograph using GSM.

2. Project Objectives Introduction: Traditional cardiology monitoring systems are based on massive storage of electrocardiograph signals. The patient is attached to a holter device during an enough amount of time, usually 24h or 48h, and then the cardiac stored signals is studied off line using appropriate software. This software includes signal-processing algorithms, as heart rate detector and pattern recognition, that allows detecting a high number of heart failures. Cardiotest has gained experience in this field during last few years of medical activity. But nowadays, there is an increasing demand for continuous monitoring systems with a high autonomy and a small size. That means we need a continuous link with a medical centre. The state of technology points to GSM mobile communications as the obvious link between patient and specialist to support the transmission. The problem is that a continuous transmission requires a huge amount of information and time. From the economical point of view, GSM does not represent a valid option for this kind of application. All these conclusions have been derived from the experiments carried out by Cardiotest and AICIA over their prototype using GSM network. Besides, patients require an intelligent system capable of detect heart pathologies, that is to say, a system in which they must not be worried about the moment in which they should transmit the electrocardiogram (ECG) to the specialist. They claim for an automatic detection

of the heart dysfunction transmission to the doctor.

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All these considerations are taken into account in the CardioSmart project proposed. GPRS network is the most suitable communication channel to solve the problem of the continuous transmission of data. With GPRS, the user of CardioSmart is going to pay only for the amount of data transmitted, and not proportional to the connection time. In GSM, only 9600bps bandwidth is available while GPRS provides a minimum of 64Kbytes. Besides, automatic pathology detection is included before the transmission. The idea of this ECG preprocessor is to reduce the amount of data transmitted. Instead of a continuous link with the specialist in which the majority of the information is useless, only the problematic ECG is transmitted. CardioSmart project is then based on a portable terminal for the acquisition, pre-processing and transmission of cardiac signals and the GPRS network (PAC) used to send the ECG signal to a host computer in the medical centre or a specialist consulting room.

Figure 1. PAC terminal block diagram A block diagram of the PAC terminal is showed in figure 1. It is a pocket size device with the following subsystems: a) An ECG Conditioning Module that consists of three or ten electrodes attached to standard patches, amplification and filtering stages. The ten-electrode version allows for complete heart diagnoses, while the three electrodes is a simplification for syncope arrhythmias. Special instrumentation amplifiers are chosen from previous designs. b) A Signal Processing Module is going to implement the whole digital processing stage that includes data conversion, heart rate detection, pattern recognition, compression algorithm and signal cryptography. The previous GSM prototype integrates an 8-bit microcontroller. In this proposal the use of a 32-bit microcontroller (MMC2107) from the MCORE Motorola family is suggested. This microcontroller includes all necessary hardware (RAM and Flash memories, coprocessor, Digital and Analog I/O signals, low-power modes...) to fulfil all electronic requirements in this applications. c) A GPRS Module from XACOM includes a data and a voice channel for the direct communication between the patient and the cardiology specialist. d) A GPS Module will provide the exact location of the patient. This module will be optional in the final application, as it can be substituted by the information provided by the telephony network.

e) Finally, a Power Module is devoted to supply the power to all modules with minimum energy consumption. The main goal of the project is to integrate the critical subsystems in a portable device: an electrocardiograph, an efficient digital processing block and a GPRS modem. The main technical problems to be solved are: a) To guarantee the reliability of the components and communication channel. Special care in the selection of components will be needed. b) To achieve electromagnetic compatibility between the Signal Conditioning Module and the Communication Module (cardiac input signal in the order of mV and 2Watts of RF signal). This will be done employing a suitable switching scheme c) To obtain maximum autonomy minimising power consumption. To find a good balance between optimal signal processing and power consumption. Communication will be established only when a cardiac disease is detected. d) To reduce the manufacturing and functioning cost at a minimum, to make this new technology accessible to any social level. e) To achieve a minimum size and weight to guarantee user's acceptability. Notice that the device will be suspended from the user's belt. A host centre will held a medical team to provide 24hour emergency attendance, a database and an Internet site, so the ECG data can be shared between

specialists or consulted from hospitals. Figure 2 is a basic scheme of the cardiology network based on the PAC terminal, the host centre and Internet access. A base station allows GPRS communication using only the telephony network to prevent uncontrollable Internet delays. This base station uses another GPRS modem. As we said before, the automatic recognition of heart failure is a demand of the patients for improving their quality of life. As a consequence, the digital processor must implement several ECG preprocessing steps. They are illustrated in Figure 3. First of all, a QRS (the three parts Q-R-S that composes a cardiac pulse shape) detector must be implemented for the heart rate calculation. Supraventricular tachycardia, bradycardia and syncope diagnoses are based on this algorithm. Several of them are described in the literature. It must be taken into account the noise interference due to the electronics and the GPRS modem. The final algorithm will be tested using international biomedical databases. Some arrhythmias will be detected using pattern recognition techniques. By comparison with the normal ECG, neural networks [1] will classify the different kind of heart diseases: blocks, flutter, atrial and ventricular fibrillation and supraventricular and ventricular scape. Again, the final algorithm will be tested using international biomedical databases [2]. Once the processor has detected an abnormal heart activity, it automatically connects with the medical centre to transmit the information. As GPRS cost is related with the amount of data, a compression algorithm based on wavelets is going to be

implemented. They have been demonstrated [3] to be very efficient to reduce the number of packages transmitted (mean compression ratios up to 8:1 in GSM network). The last task of the processor consists in the encryption of the ECG signal, because national and international regulations force the privacy of this personal information.

Figure 2. Basic scheme of the cardiology network

Figure 3. Flow diagram of processor tasks.

Objectives:

1. The design and realisation of a novel intelligent and portable electrocardiograph device with a GPRS link (PAC) for monitoring the heart activity of patients and the automatic detection and transmission of fundamental heart failures. This design will comprise several subsystems: microcontroller system for data signal analysis, communication subsystem including GPRS/GSM standard links and power subsystem. 2. Improving the quality of life of cardiology patients, as they have not to be confined in hospitals. They will feel free of walking or even travelling but keeping contact with their cardiology specialist or hospital. A direct and almost instant medical support is provided, as a voice channel is included in the GPRS connection. The adjustments of the system to other countries in Europe will allow to extend the initiative to the rest of the European Community and setting up a novel collaborative environment to share data for continuity of care.

Basically, this general objective will be achieved by means of the following detailed measurable objectives: 1. Design of the PAC terminal prototype. This design will be done according to concept defined by a patent owned by Cardiotest and AICIA plus the additional requirements for the GPRS link and the digital processing stage. The main objective will be to achieve the maximum autonomy, at least 24 hours. Target: PAC prototype design. 2. Selection of algorithms for QRS detection and pattern recognition, according to the standards defined in biomedical signal databases. The result must be to detect the maximum number of pathologies. Selection of algorithms for compression and cryptography. The result must be to optimise the amount of data transmission. Target: Selection and implementation of digital algorithms for heart failures detection, digital compression and cryptography. 3. Fabrication of prototype version of the PAC terminal.
Target:AnindustrialPACterminalaccordingtotechnicalspecificationsandprevious design.

4. Technology transfer from AICIA to TELEASISTENCIA CARDIOTEST addressing the final features of the PAC terminal. Target: Technology transfer to TELEASISTENCIA CARDIOTEST. 5. Industrial version of the terminal will be commercialised by TELEASISTENCIA CARDIOTEST.

The objective will be setting a Spanish GPRS network during the first year, with the collaboration of some hospitals and specialist. The experience will be extended to other European countries during the second year Target: a) A Spanish GPRS network for transmission and storage of ECG signals. b) Trials to some European countries.

The main risk of the project is to achieve a good balance between signal processing capabilities and power consumption, as, to our knowledge, there no exists any intelligent cardiology portable device as the one proposed in this project in the market. [1] B.G. Celler and P. Chazal. "Low Computational cost classifiers for ECG diagnosis using Neural Networks", Proceeding of the 20th Annual International Conference of the IEEE Engineering in Medicine and Biology, vol. 3, Nov 1998, pp. 1337-1340. [2] T. Penzel, B. Kemp, G. Klsch, A. Schlgl, J. Hasan, A. Vrri and I. Korhonen, Acquisition of Biomedicals Signals Databases, IEEE Engineering in Medicine and Biology Mag., vol. 20, no. 3, May/june 2001, pp. 25-32. [3] R.S.H. Istepanian and A.A. Petrosian. "Optimal Zonal Wavelet-Based ECG Data Compression for a Mobile Telecardiology System". IEEE Engineering in Medicine and Biology Mag., vol. 4, no. 3, Sept 2000, pp. 200-211.

3. Participant List

Date Date Parti Parti Participant Participant Enter Exit c. Short c. Country Proje Proje Name Role No. Name ct ct Start End of Teleasisten CARDIOTE Espa of C 1 cia Projec ST a Projec Cardiotest t t Asociacin para la Start Investigaci End of Espa of ny AICIA MB 2 Projec a Projec Cooperaci t t n Industrial de Andaluca 4. Contribution To Programme/Key Action Objectives This contribution of this project to the IST Subsystems objectives, described in the 2001 Workprogramme, can be summarised as follows: 1. The proposed device is composed by several subsystems (electrocardiograph, signal processing system, communication system, positioning system, power stage...). These subsystems must be designed and validated separately and then integrated taking into account their interactions. 2. Hardware/software important role in this design.

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3. Advanced signal processing stages, including pattern recognition, data compression and cryptography are crucial in this project. 4. Manufacturing processes must be carefully analysed, because the realisation of medical instrumentation that manages very weak signals is very critical. 5. Design, manufacturing and validation of this medical device must comply with medical specifications. The final device must obtain EU certification. 6. The device must be portable and include wireless communications. 7. The weight and size of the device must be minimised, as it will be applied to patients that suffer from heart diseases. This device must be fully accepted by the user. 8. The total power consumption of the device is also critical because the autonomy of the system should be as large as possible. It is foreseen that two blocks will be high power consuming: the Signal Processing Module that is in charge of the detection of electrocardiograph anomalies, and the Communication Module. At least, 24-hour of autonomy is necessary. Notice that the batteries used in this device must not be charged while it is being connected to the patient, and will have to be substituted for their charge. 9. Not only the cost of the device is critical, but also the performance of the compression algorithm, because it will drastically decrease the volume of data and therefore the communication cost in GPRS.

10. This device must be user-friendly, because in a potential case of a heart attack, the patient must be capable to manage it, answer a call, maintain its connectivity, etc. 11. There are other topics included in the 2001 Workprogramme under the subsystems action line that will also be consider in this project, as it is the use intelligent signal processing, RF design interactions... This proposal also satisfies all conditions to be considered as a trial, as a sufficiently deployed technology, as it is the case of the proposed system, is transferred to a company to improve their products. It is clear that AICIA, the supplier, will transfer the technology to TELEASISTENCIA CARDIOTEST, the user. The proposal also indirectly relates with several objectives within the IST 2001 Workprogramme, as it is the case of the following action lines: KEY ACTION I - SYSTEMS AND SERVICES FOR THE CITIZEN I.1 Health I.1.1 Intelligent environment for citizen centred health management KEY ACTION II - NEW METHODS OF WORK AND ELECTRONIC COMMERCE II.4 Information and network security and other confidence building technologies II.4.2 Enhancing security in electronic transactions

5. Needs and Benefits Actual cardiology monitoring systems are improved in terms of storage capacity or autonomy. But new mobile communications technology is opening new horizons for new ideas that will improve the quality of life of patients. Portability and autonomy are concepts very close to actual mobile communications. So the junction of this concepts led to new applications that could not be exploited some months ago. Is the first time to our knowledge that a portable electrocardiograph (PAC) allows the continuous detection and on-line GPRS data transmission is put in place in the cardiology market. The collaboration between AICIA and TELEASISTENCIA CARDIOTEST has been oriented following this perspective during last few years. The first system product developed was a pocketsize personal portable electrocardiograph equipment (see Figure 4) with a frequency modulated transmission using the basic telephony network (transtelephonic electrocardiograph system). The system only allowed the patients to transmit their ECG whenever they feel bad to a 24-hour duty medical centre. This system also includes a QRS detection algorithm for automatic syncope detection. That was an important feature over the first system. The syncope was detected without the participation of the patient. This portable electrocardiograph is commercially available since 1999. The next step consisted of using the new technology possibilities, that was, GSM transmission. A prototype

including a GSM data modem (see Figure 5) has been developed and it has been proved that concept was technically feasible. Nevertheless, despite of the technological evolution, communication infrastructure and advanced hardware needed for complex highquality telemedicine services, they remain very expensive. GSM transmission cost is related with time of connection, leading to a very expensive continuous monitoring system. Also the power consumption of a continuous GSM data transmission led to a very reduced autonomy. The main conclusion of these experiences is the necessity of joining together portable equipment, continuous monitoring system, power consumption, cost of transmission and optimisation of the amount of data to be transmitted. One solution to this problem is the use of the GPRS network. This novel communication protocol is going to allow a non expensive transmission and a cost related with the amount of data transmitted. A GPRS modem will be soon available to solve the link between the patient and specialist. An additional solution consists of reducing the amount of data to transmit. It must be taken into account that in a continuous monitoring system, the majority of the information is a normal ECG signal. But the fact is that the information of interest for the specialist is just the abnormal ECG signal. Instead of doing the signal processing after the transmission, as holter equipment in hospitals, the signal processing will be done before the transmission. The result is that only the important information is transmitted so the amount of data and the cost for the patient is reduced. If we combine an intelligent detection system with data compression of information, the amount of data is not only reduced but also optimised.

In this proposal the development of a new terminal (PAC) with portability, autonomy, signal acquisition and digital processing, data compression and encryption, and a GPRS link is suggested. GPRS modem provides a data channel and also a GSM voice channel for the direct communication between patient and specialist. ECG information is transmitted to a host computer with a database, so the specialist will diagnose and propose actions to the patient. It also allows a continuity of care, even if the patient is geographically far from the cardiologist. Additionally, the host computer could implement an Internet site, so the information will be consulted from hospitals or other specialists, even if they are far from the host computer. The system including the portable terminal plus a host computer with external access may become a complete cardiology network that will improve the quality of life of people. To summarise, the main innovation of the proposal is the integration of a set of subsystems using new technologies, such us GPRS data transmission and GSM voice link, to solve the problems of cost and continuous monitoring of the current cardiology devices.

Figure 4. Actual portable electrocardiograph device commercialised .

Figure 5. Photograph of the prototype including GSM data transmission