ASTM: American Society for Testing and Materials Wearable devices are also used for patient management and disease management. Nowadays, all of these time-consuming jobs could be terminated and patients could be liberated from instrumentation and bed by wireless technology. So managing interference between the old system and the new one and using spectrum properly are challenges of wireless technology applied to medical applications. Some wearable technology applications are designed for prevention of diseases and maintenance of health, such as weight control and physical activity monitoring. Nowadays, WLAN are provided in almost US hospitals. The Radio Frequency Wireless Technology in Medical Devices provides recommendations to develop and support safe and effective wireless medical devices. A device displays patient’s signals without adhesives or wires. Reliability is one of the most important factors in a successful healthcare system. The standards of WLAN was first introduced in 1997, namely IEEE 802.11. As medical devices become smaller, more capable and easier to implant, there’s a parallel need to keep up with ways to power them. This will not only trim down the deployment cost significantly but also enhance the quality of the network. In this study, we conducted a literature review of wearable technology applications in healthcare. Portable devices such as heart rate monitors, pulse oximeters, spirometers and blood pressure monitors are essential in… Through federal law, the FDA has formally recognized several consensus standards related to RF wireless medical devices. Specifically, the new system should be low cost and not interfere with existing infrastructure. PDAs carried by physicians, or laptop base stations in ambulances) [Shnayder05]. For example, devices operating under FCC Part 15 rules must accept any interference from primary users of the frequency band. 5. Traditionally, the sensors for these instruments are attached to the patient by wires; and the patient sequentially becomes bed-bound. Another standard which is being designed specifically for MBWA services, a so-called IEEE 802.20 or MobileFi, has the wider range and higher mobility capability in comparison with WiMAX. In this paper, we will discuss several of these projects, highlighting their architectures and implementation. The survival rate drops to 2%-4% after 12 minutes have gone [Shih04]. ISO/IEEE 11073-1030x Device Specializations Airborne modules help these machines have wireless communication, reduce wiring and make it compatible with modern network. Examples of areas that utilize RF wireless technology include: The Federal Communications Commission (FCC) oversees the use of the public Radio Frequency (RF) spectrum within which RF wireless technologies operate. 6.1 Life Star® vital signs monitoring Systems In many mission critical applications, it is vital that devices do not fall into battery exhaustion. Each patient lead can be designed as a separate battery-powered Bluetooth device that communicates with a battery-powered Bluetooth-enabled patient monitor. Licensed spectrum allows for exclusive, and in some cases non-exclusive, use of particular frequencies or channels in particular locations. Brian Carmody. 3. We focus on Wireless Personal Area Network technologies, WiMAX, WiFi and Zigbee. And, there is no one-size-fits-all approach, as regulatory and testing requirements can vary by market based on your device’s technology. With wireless continuous medical monitoring systems, patients’ information such as blood pressure, heart rate, and electrocardiogram can be sent instantly to specialized medical centers to store and process properly. The large number of wires used around the operation table prevents the medical team’s access to the patient. Potential and Challenges”, High Confidence Medical Device Software and System (HCMDSS), June 2005 Another technology using in WPANs is Zigbee, a so-called IEEE 802.15.4. The devices constantly transmit data from patients and clinicians that can be used for analytics purposes or improved operations. In addition, whenever patient needs to be moved, all monitoring device has to be disconnected and then reconnected later. Figure10: Between wearable WBAN and implanted WBAN[Takizawa08]. By using this transmission media, communication between departments within hospitals, from hospital to hospital can be made on the fly. These benefits can greatly impact patient outcomes by allowing physicians access to real-time data on patients without the physician physically being in the hospital and allowing real-time adjustment of patient treatment. http://ieeexplore.ieee.org/document/4215486/, [Shnayder05] Victor Shnayder, Bor-rong Chen, Konrad Lorincz, Thaddeus R. F. Figures 12 illustrates architecture of Wireless B.O.H.M system. Devices using Zigbee has less than 1% life time in active status. The FDA recommends that you periodically consult the FCC website for new specifications and updated information. The standards’ primary goals are “providing interoperability for patient-connected medical devices and facilitating the efficient exchange of vital signs and medical device data in all health care environments”[Cooper02]. Many existing biomedical implantable devices operate in the low-MHz fre-quency range, such as the widely accepted 13.56 MHz industrial, scientific, and medical (ISM) band. Wearable technologies can be innovative solutions for healthcare problems. After the introducing of 802.11a and 802.11b, WiFi alliance formed and started its work certifying wireless based devices. The use of wireless technologies in medical environments is bringing major advantages to the existing healthcare services. After a brief discussion of standards being used applications and location of wireless network in a healthcare system, we will identify projects and research groups on wireless medical application, and commercial products. Using the system can reduce the hospital stay of patient and increase patient safety and mobility. With the system using WBAN or wireless sensor network, data must go through a number of hops before it reaches the sink. For example, with high-risk patients, the services with higher QoS should be used. ISO/IEEE 11073-20xxx: Medical Device Application Profile, IEEE 1073.4.1 Physical Layer; The Association for the Advancement of Medical Instrumentation (AAMI) TIR 69 – Risk Management of Radio-frequency Wireless Coexistence for Medical Devices and Systemsand American National Standards Institute (ANSI) C63.27: Standard for Evaluation of Wireless Coexistencediscuss testing and risk management for wireless medical device coexistence. CIMIT teams have been designing and constructing “Operating Room of the Future, a fully functioning operating room in which novel, integrated technologies and new processes are introduced, evaluated, and improved, and through which patients move with far greater comfort, speed and safety”[ORF]. When manufacturers submit pre-market notification to the FDA for device clearance or approval, declarations of conformity to these standards may eliminate the need for certain safety and effectiveness data. From patient’s aspect, one of the most important issues is how comfortable they feel when using these new applications. With the advancement of wireless technology, wireless devices can be used to reduce medical errors, increase medical care quality, improve the efficiency of caregivers, lessen the caregiver-lacking situation, and improve the comfort of patients. As wireless developers and device manufacturers increasingly utilize RF wireless technology, they should consider the following: All wireless technologies face challenges coexisting in the same space. by admin | Dec 15, 2017 | Latest News, What is a Medical Device? The number of application of WiMAX is rapidly increased and some other applications of WiMAX will be discussed in the later sections of the paper. The first and oldest wireless technology used in medical application is wireless local area network (WLAN). http://portal.acm.org/citation.cfm?id=1141325&jmp=references&coll=GUIDE&dl=GUIDE&CFID=7321856&CFTOKEN=76762787, [Otto06] Chris A. Otto, Emil Jovanov, and Aleksandar Milenkovic; “A WBAN-based System for Health Monitoring at Home”, Journal of Mobile Multimedia,Jan 2006 IEEE 802.20 will use the licensed bands below 3.5 GHz and provide data transmission speed over 10Mb/s for user speeds up to 250 km/h. Diagnostic, monitoring, and treatment systems are becoming wearable and implantable, which give them numerous advantages over bulky medical equipment. The FCC (Federal Communications Commission) and the FDA (Food and Drug Administration) each produce guidelines and regulations for launching and marketing these devices, and every device needs to comply. A Bluetooth profile provides guideline of how different applications use Bluetooth wireless technology to set up a connection and exchange data. A number of physiological monitoring systems based on the motes have been proposed and deployed in real clinical settings. Integrated wireless technology, these wireless devices could communicate with a gateway that connects to the medical center’s network and transmits data to health data stores for monitoring, control, or evaluating in real time or offline after storage. - ISO/TR 21730:2007 - Health informatics -- Use of mobile wireless communication and computing technology in healthcare facilities Because the airways are shared, the functioning of your wireless medical device may be affected (such as data loss or disruption) by other wireless devices near you. Wireless medical device regulations in the United States In the United States, there are two major bodies overseeing devices in the health sector. The recent approvals demonstrate not only the industry's focus on injectable medical technology, but also the regulatory support of these miniature wireless devices. ; “IEEE 802.16/WiMAX-based broadband wireless access and its application for telemedicine/e-health services”, IEEE Wireless Communications, February 2007 The system collects periodic and continuous data and then transmits it to the centralized server. [IEEE] Institute of Electrical and Electronics Engineers IEEE 802.11a has a range of 100 feet and 802.11b has coverage of 350feet outdoors and 150 feet indoor. For more information on recognized standards, go to the FDA Recognized Consensus Standards database. Figure 3: Conceptual model for X73-based medical devices [Yao05]. Adhering to this frequency band not only We encourage health care providers and patients who suspect a problem or hazardous event to file a voluntary report through MedWatch: The FDA Safety Information and Adverse Event Reporting Program. 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