Matthias Wagner 1 , Benjamin Kuch 2 , Carlos Cabrera 1 , Peter Enoksson 3 , Arne Sieber 4 1 FH Frankfurt am Main - University of Applied Sciences, Germany 2 Scuola Superiore SantAnna - RETIS Lab, Pisa, Italy 3 Chalmers University of Technology, Gothenburg, Sweden 4 Institute of Micro and Nano Technology (IMEGO AB), Gothenburg, Sweden AbstractThe telemedical system focuses on the measurement and evaluation of vital parameters, e.g. ECG, heart rate, heart rate variability, pulse oximetry, plethysmography and fall detection. Based on two different designs of a (Wireless) Body Area Network connected to an Android smartphone the Real-Time system features several capabilities: Data acquisition in the (W)BAN plus the use of the smartphone sensors, patient localization, data storage, analysis and visualization on the smartphone, data transmission and emergency communication with rst responders and a clinical server. In the rst ZigBee based approach smart and energy efcient sensor nodes acquire physiological parameters, perform signal processing and data analysis and transmit measurement values to a coordinator node. In the second design sensors are connected via cable to an embedded system. In both approaches data are transferred via Bluetooth to an Android based smartphone. Several challenges are discussed: Measuring, analysing and visualizing medical parameters characterize the system as safety critical, requiring special development procedures and adherence to safety standards. Reliability of wireless data transmission has to be optimized. Handling medical data requires security measures on each level of the system hierarchy. I. INTRODUCTION Monitoring and recording of physiological parameters of patients outside the clinical environment is becoming increasingly important in research as well in applied physiology and medicine in general. Environmental physiology as one important example, is a scientic discipline [1] that gained signicance with the continuing advances in technology exposing humans to greater extremes and extreme environmental conditions. For instance extreme sports like endurance running, climbing and high altitude mountaineering are more popular also in recreational settings. Presently very little is known about acute adaptation mechanisms, and especially about long term changes in physiological function, e.g. in professionals which are regularly exposed to extreme environmental conditions such as divers, astronauts or pilots. How age and gender inuence these adaptations is also largely unknown. A sound understanding of human physiology in such environments is however the basis for being able to give recommendations and draft guidelines on how and to what extent exposures to extreme environments can be tolerated in a safe way with minimized health risks considering short, medium as well as long term effects. Technology is advancing but knowledge of physiology is lagging behind thus there is an urgent need for rapid advances in these research topics. Environmental Physiology is the area of life science that describes the human physiological and behavioral changes, in particular, acute responses, adaptations, habituation, acclimation and acclimatization. The main obstacle to the assessment of physiological changes in extreme environment is the fact that most ndings have been collected during laboratory conditions with frequently bulky instruments. In eld measurements outside laboratory are not feasible, simply as suitable instrumentation that can withstand such harsh environments was not available. Thus research is far away from the real eld conditions when different environmental factors could act synergistically or vice versa an individual response to environmental stimuli is complex. Moreover, in the general context of the reductionistic (cellular and molecular) wave that has swept over biomedical research during the last 20-30 years, many fundamental physiological mechanisms still continue to be poorly understood [2]. Applying laboratory measurement equipment in eld is not enough, as measurement equipment and the measurement setup are also subject to cross interferences caused by environmental stressors. Instrumentation developed especially for application in extreme environments is the key for rapid advances in environmental physiology. Physiological parameters of paramount interest are among others: O 2 saturation (SO 2 ), arterial blood pressure, heart rate and variability, breathing parameters, etc. Diving is one example of an extreme environment and as such a research eld of environmental physiology. Medical concerns about such activities derive from two major shortcomings: scanty knowledge of diving physiology and lack of monitoring of vital parameters during diving. Both deciencies are virtually related to the absence of instrumentation suitable for underwater measurements of simple but crucial physiological parameters. First prototypes were developed in the past by our team. [3], [4] Another important medical eld, where autonomous data recording and real time wireless data transmission is of benet, is in preventive medicine and post treatment/survey of patients with cardiac heart failure (HF) pathology and/or 10th International Workshop on Intelligent Solutions in Embedded Systems, 2012 ~ 33 cardiovascular diseases. HF represents a diffused pathology in the industrialized countries with high morbidity and mortality risk and a subsequent high request for hospitalization. In fact, in these countries, the rst mortality cause is related to the cardiovascular diseases: in 2005 the US AHRQ (Health and Human Services Agency for Healthcare Research and Quality) reported the costs of the top ten morbid conditions: 76 B$ for cardiovascular pathologies (48 B$ related to the necessary hospitalization), 69 B$ for cancer, 39 B$ for diabetes and 39 B$ for osteo-articular diseases. The incidence and the prevalence of HF, as nal status of all the chronic cardio-pathologies, are continuously growing. In the USA a 300% increase of HF in 15 years has been related with the improving of cardiology knowledge and care, and to the aging of the population. It has been estimated that in 2020 HF and atrial brillation will represent the most important hospitalization causes. Furthermore it has been estimated that in Italy 10% of the over 65 population is affected by HF [5]. The difculty of management of HF is not only related to its diffusion, but also to the typical clinical course of the disease characterized by frequent and cyclic haemodynamic instability related to age, co-morbidity, cognitive decay, therapy effectiveness, ambient and social factors. Literature reports the clear and effective advantage of specic patient monitoring well tuned to the patients clinical condition. Reported results of a metanalysis on 5000 patients by Alister [6] point out that specic assistance programs like a phone hotline to medical staff (for example a nurse) or by outpatient medical follow-up assure both a reduction of re-hospitalization and also mortality. In daily practice, management of patients with HF relays on relatively simple physical signs such as the ones mentioned above plus body weight which however need to be carefully monitored in order to optimize the efciency of treatment, to prevent the relapse of HF and the need of hospitalization. A user wearable breathing recorder was already described in [7]. There the acquired data are transmitted to a nearby installed computer. Young [8] presents an oximeter with wireless data transfer. Both approaches may be useful for clinical applications, but for continuous monitoring of patients outside the clinical environment, a wearable and miniaturized recording system is necessary. Previously our team has developed a GSM based data logger, which was able to record breathing rate and SO 2 and transmit relevant data to the clinical server [9]. Technical solutions enabling the eld of Telemedicine promise to mediate the impact of changing population statis- tics. Most important is the eld of on-line monitoring and analysis of vital parameters. Different kinds of wireless tech- nologies promise to ensure patient compliance. Especially Body Area Networks (BAN) coupled with these wireless tech- nologies [10] allow the setup of a comprehensive telemedical infrastructure. Depending on the environment two different subsystems are central to a BAN: 1) An embedded system as a sensor platform. 2) A Wireless Sensor Network (WSN) tailored to the specic task. In this case the BAN is usually called a Wireless BAN or WBAN. With respect to WBANs ZigBee/IEEE 802.15.4 is widely used in WSN. 2008 a standardization of WBANs near to the human body has been started [11], [12]. The IEEE 802.15 Task Group 6 (BAN) is developing the communication standard optimized for low power devices and operation on, in or near the human body [13]. Smartphones and Tablet PCs take over tasks of the traditional PC, once again changing the hardware base of computer science. Therefore it is a natural development to use smartphones as mobile sinks for WSNs (e.g. [14], [15]), and integrate them as central modules of a telecare system (cf. [16], [17]). In addition to a (W)BAN a typical smartphone features around a dozen internal sensors, some of them may be used in a medical application (e.g. [18]). Telemedical Systems are by denition Safety Critical Systems (SCS), whose development is governed by national and international safety standards (e.g. IEC 60601 based standards). In addition to functional safety concerns security in the (W)BAN (cf. [19], [20], [21], [22]), between the (W)BAN and the smartphone (e.g. via Bluetooth [23]), its operating system [24] and a wider infrastructure is a serious issue. The main idea for the current project is to develop an Android OS based data collection platform, that can collect physiological data from multiple sensors, perform signal pro- cessing and analyses, store data in an internal memory and transmit data via a UMTS connection to a clinical server. This paper describes two BAN approaches: 1: The WBAN architecture is based on the ZigBee/IEEE 802.15.4 stack. 2: The BAN architecture uses an Atmel board as sensor platform. Both BAN designs are connected via Bluetooth to an Android smartphone, which features apps for analysis and visualization of vital parameters. Example sensors foreseen in the rst prototype include sensors for O 2 saturation of the blood, ECG and heart rate variability. In addition smartphone sensors (e.g. accelerometers) are used to gather additional information, e.g. fall detection. All information may be transferred to a medical database for further distribution and analysis. II. DESIGN NO. 1: WBAN A. ZigBee/ IEEE 802.15.4 Sensor nodes usually do not require high bandwidth for typical applications (hundreds of bits/s). For a WBAN design some requirements on the communication should be imposed: Resistance to interference, adequate throughput and security [25]. Therefore communication protocols such as Bluetooth, ZigBee, and IEEE 802.15.4 are serious candidates for the im- plementation of a WSN. ZigBee is a standard communication protocol for low-cost, low-power, wireless sensor and control 34 networks [26]. Just as Bluetooth, ZigBee operates on the 2.4 GHz radio frequency but with a maximum data rate of 0.25 Mbps [27]. Fig. 1. OSI vs. ZigBee/IEEE 802.15.4 Stack In addition the ZigBee Alliance group has developed ZigBee Health Care to be used by medical and non-medical devices in order to establish a universal communication standard in a health care environment. A major objective is to allow an indi- vidual to perform tasks that otherwise would be very difcult due to a disability or medical condition. To accomplish this ZigBee Health Care fully supports standards like ISO/IEEE 11073 [26]. B. WBAN Architecture Figure 2 shows the WBAN architecture. In this architecture the primary data processing is done by the sensor nodes, including the physiological signal processing in the micro- controller of the nodes. The secondary data processing is per- formed in the smartphone. This includes data representation, data ltering, graphical interface and data synchronization. Finally the last and most demanding data processing together with the database management is performed in the medical server. The medical server allows local and remote access for medical personnel via the Internet. Our design encompasses communication protocols like the ZigBee/IEEE 802.15.4 stack for intercommunication within the WSN, Bluetooth (Serial communication via RFCOMM) to link the WSN with the smartphone, and WiFi or UMTS com- munication between the smartphone and the medical server. Our mote design uses the Atmel ZigBit TM 2.4ATZB- 24-A2/B0 [28], which features an ATmega1281V C, AT86RF230 Transceiver, 16 GPIOs, I 2 C Bus, 222kHz data rate [29], 1-wire interface 15.4 kBit s 125 kBit s [30], 4 ADCs 10 Bit. Wireless data transmission results in a higher patient com- pliance because there are no uncomfortable wires. On the other hand may the fear of electromagnetic radiation lower the acceptance. This served as a motivation for the IEEE 802.15.6 Fig. 2. WBAN Architecture working group, with the goal of minimizing transmission power, range and SAR [13]. Future WBAN architectures will use the new standard. III. DESIGN NO. 2: BAN WITH ATMEL BOARD In terms of the sensor nodes and the gateway, Atmel solu- tions promise to provide an ideal platform for Telecare devices, reliable communication together with power efciency, in a compact design [31]. For this a high-performance, low power 8-bit Atmel Microcontroller is available. It features a 8-bit AVR CPU, a maximum operating frequency of 32 MHz, 128 KB In-System Self-Programmable Flash, 8 KB internal SRAM, 2048 bytes EEPROM, 2 Universal Asynchronous Receiver Transmitters (UART), 1 Serial Peripheral Interface (SPI) and 16 channels ADC with a resolution of 12 bits and 2000 kSps speed, 4 channels DAC with a resolution of 12 bits. IV. WIRELESS PLETHYSMOGRAPH/ PULSE OXIMETER MODULE A. Pulse Oximetry Overview Due to restricted space only the pulse oximetry module will be described. The ECG hardware was inherited from a previous project and can be found in [32]. Pulse oximetry is an optical method to measure oxygen saturation, heart rate and heart rate variability. It is based on light absorption. Oxygenated Hemoglobin (Hb) has different light absorption spectra than deoxygenated Hb. Thus the wavelength of red light (660nm) is compared with the wavelength of infrared light (940nm). The red/infrared light is received by a photo detector, which converts light into current. The output current of the photo detector is proportional to the light intensity of each light source. The light sources are switched on alternately. Each source is switched on for a certain period and the current is measured and converted into a voltage. The output signal 35 Fig. 3. BAN Architecture lies between 1 Hz and 2 Hz [33] and consists of a small AC component ( 1V) and a large DC component ( 10mV peak- to-peak) [34]. The AC component is caused by the arterial pulse. The DC component is caused by scattered light, residual arterial blood, venous blood and bloodless tissues. The SpO 2 level is calculated by taking the Root Mean Square (RMS) of the red/infrared AC values, computing the ratio between the red and infrared RMS values and applying the ratio value into a 3 rd order polynomial t of the calibration curve for oximeters [35]. B. Design Outline In order to tailor the system to specic application needs the puloximeter application report SLAA274A from Texas Instruments (TI) [34] was used as basis and adjusted. Instead of using the TI MSP430FG437 microcontroller, an Atmel ATXmega128A1 is used with the following advantages: Direct Memory Access Controller Fast 12 bit programmable (amplifying) ADC, which can read 8 ADC channels in parallel (up to 2 MSps sample and conversion rate) Event system Interrupt handling with congurable priorities 8-bit RISC architecture with max. frequency of 32Mhz 128 kBytes Flash, 8 kBytes SRAM, 2 kBytes EEPROM In addition to the microcontroller the hardware includes an analog circuit, consisting of a LED drive circuit, photo diode output processing and a ChipOx MiniMed ngerclip sensor. The rmware of the device is developed in C (GNU C com- piler WinAVR 20100110) and AVR Studio 4.18. The rmware of the module consists of four major parts: LED control, signal amplication, LED data handling and processing and data transfer. Data is transferred via serial interface. The DMA controller of the ATXmega128A1 is used to allow high speed data transfer with minimal CPU intervention. In this way, the whole data transfer can be processed in 200s CPU load. V. ANDROID SMARTPHONE A. Android Smartphone An Android based smartphone has been chosen because of its powerful and Java-based development kit, Android SDK, its excellent documentation and library including classes like BluetoothHealth, and the possibility to develop on many platforms, like Linux, Mac Os and Windows [36]. For devel- opment different smartphones are being used with Android 2.3.5 and 4.03. B. Android Apps As mentioned in the System Architecture the smartphone should manage not only data acquisition from the W(BAN), but also synchronization and provide a Graphical User Interface (GUI), among other tasks. In order to do so an Android application is necessary, this application should feature several functions, among these are: Data acquisition from the (W)BAN via Bluetooth; data analysis, i.e. comparison with medical norm values; GUI for conguration, data visualization, and communication; data transfer (synchronization) to a medical server via WiFi or cellular network. Android applications are divided into Activity classes. An Activity is both a unit of user interaction, and a unit of execution which provide reusable, interchangeable parts of the ow of UI components across Android Applications [37]. In essence the application is responsible to detect the Bluetooth gateway and establish a full duplex communication, including device discovery, pairing, debugging and communication, and to be able to connect to the medical server through the Internet enabling data synchronization between the server and the W(BAN) in soft real-time. The application features numerical analysis and graphical representation of the captured physiological data, an activity for the patients prole, physical condition, disease history, etc., and activities for the connection with the medical server. For this project some interesting packages available in the Android SDK are [36]: Android.Bluetooth, Android.database.sqlite, Android.net, Android.webkit, javax.net.ssl, Android SDK tool [17]. The use of third party libraries is optional keeping the validation effort for a Safety Critical System in mind. The app is also responsible to present a GUI, whose design represents the captured data in an understandable way.Together with the basic requirement of a state-of-the-art Android app, the GUI has therefore three principal modes: Conguration, display for patients, display for medical personnel with re- stricted access. For the proposed application internal smartphone sensors, e.g. accelerometer, GPS, etc., provide additional opportunities, i.e. patient localization and possible detection of a fall. Based on the evaluation of the acquired data the app starts 36 Fig. 4. Android Prototype Application communication to predened rst responders. Android based on Linux lacks a real-time kernel and cannot support hard real-time requirements. Based on the measure- ments of Mongia and Madisetti [38], tests of the complete, layered system are being conducted. VI. SECURITY ISSUES Security in Wireless Sensor Networks is of major concern (cf. [19], [22]). The security issues in a WBAN differ in several aspects from those in other applications. In a WBAN for medical applications there are only a few motes, as in our design. Nevertheless a typical problem is to distinguish an attack from a network failure. Therefore detection mechanisms are required. Guided by the OSI model layering-based attacks [22] on the ZigBee/IEEE 802.15.4 stack (cf. g. 1) may be countered by the combined ZigBee/IEEE 802.15.4 security model (cf. [19]). Currently evaluations are under way to assess the permissible overhead introduced. In a BAN based on sensors attached to an embedded control system security issues are much simpler. Both approaches communicate with an Android smartphone via Bluetooth. Because of the widespread use of Bluetooth in mobile phone communication numerous threats exist (cf. [39]). Threat mitigation involves properly designed communication between the (W)BAN and the smartphone, e.g. a dened software engineering process, use of the encryption and authentication mode, comprehensive testing. Android is one of the most popular operating system for smartphones. Despite this fact the Android security model is in need of further enhancements. Shabtai et al. [40] identied the major threats to the operating system. The Android soft- ware stack is built on a Linux kernel. The Android security framework is based on the Linux security system, the cellular network provider and Android specic security mechanisms, i.e. application permissions, component encapsulation and signing applications [40]. Shabtai et al. propose enhancements to the Android system to increase protection. VII. RESULTS First reliability test runs with a WBAN prototype with a scalable number of ZigBee motes resulted in a 4-6.5 % packet loss (s. Table 1). In the rst and third setup data were sent from a ZigBee endpoint via a router to the coordinator. In the second setup the endpoint sent data directly to the coordinator. Run-Time Payload Packets sent Packets lost Security [Days] [Bytes] 10 10 1.26 10 5 5 % none 10 10 1.26 10 5 4 % standard 10 10 1.26 10 5 6.5 % standard TABLE I ZIGBEE/IEEE 802.15.4 RELIABILITY TESTS Trade-offs are necessary with respect to battery life, data rate and ZigBee/IEEE 802.15.4 security settings. Unfortunately increasing security does not only introduces a secure way to send and receive data, but also introduces an impact on the performance, and battery life of the sensor nodes and the phone running the android application. With standard security only 54.54% of the usable payload is available. Battery life was reduced by 14.28% in a node functioning as a coordinator. In order to mitigate the data loss re-transmitting information in slow sampling rate nodes can be used, and interpolation techniques for nodes with faster sampling rates. Higher level encryption resulted in a drastic reduction of the data rate. Range is not an issue for medical WSN with the used motes. Range tests revealed sufcient range for the application. A typ- ical setup for research in environmental physiology comprises three motes. ECG and Plethysmograph/Pulse Oximeter data have been acquired, transferred and displayed in an Android App. Two different smartphones, a HTC Desire HD with Android 2.3.5 and a Samsung Nexus S with Android 4.03, have been used to collect and visualize the WBAN data. In addition the Android App features the input of user/patient data and the UMTS/WIFI data transfer to a medical server database. 37 VIII. CONCLUSION AND FUTURE WORK The rst design approach, a WBAN, fullls the basic requirements. Reliability and range are sufcient. Due to fears with respect to transmission power of wireless systems the upcoming standard IEEE 802.15.6 will be considered for fu- ture designs. The combination of the WBAN with an Android smartphone offers a large functionality. Vital parameters can be stored, analyzed and visualized with GUIs designed for the end-user. 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