Compliance & Regulatory Info Sheet Nr. 1 | Wireless Medical Devices & Connected Healthcare Applications | July 2014 A life-saving medical device needs to provide error-free data transmission and low latency, implying that the data must be available in almost real-time. Since these are contradictory objectives it is extremely challenging to meet both goals. The result depends highly upon the employed wireless transmission technology and the frequency band it is used in. Throughout the world a range of frequency bands is available for transmitting medical data: Industrial, Scientific and Medical (ISM) bands Originally conceived for non-communication-related use of radio spectrum, the Industrial, Scientific, and Medical (ISM) bands have come to be dominated by popular communication technologies such as WiFi, Bluetooth, and Near Field Communication. The success of these technologies, WiFi in particular, is something to consider in the context of spectrum management strategies, especially when designing medical devices with integrated wireless technology. Because communication devices using the ISM bands must tolerate interference from ISM equipment, unlicensed operations are typically permitted to use these bands. Although the manufacturer still needs to obtain type approval for using these bands, no licenses are required for operating them. This makes using these bands attractive for manufacturers who want to sell in many different countries. The main disadvantage of ISM bands is that many other devices will be using the same band at the same time. Examples of the ISM frequencies are the 2400-2500 MHz and 57255875 MHz bands which are used for wireless LAN (802.11a,b,g), Bluetooth® or the new extremely high 60 GHz frequency band. 902 928 MHz MHz 2.4 GHZ 2.4835 GHZ 500 MHZ 125 MHZ 83,5 MHZ 26 MHZ 5.725 GHZ 5.875 GHZ 61.000 GHZ 61.500 GHZ Frequency The regulatory agencies in different parts of the world monitor these bands according to different criteria. Wireless devices must comply with the specifications of the relevant governing regulatory body. Although the regulatory requirements do not affect the interoperability of IEEE 802.11-compliant products, the regulatory agencies do set certain criteria in the standard. It is the responsibility of the wireless device vendor to obtain product certification from the relevant regulatory body. In the USA, the use of the ISM bands is governed by Part 18 of the FCC rules, while Part 15 contains the rules for unlicensed communication devices, even those that use the ISM frequencies. In the USA there are also Licence Free Part 15 bands for „Short Range Devices“ that are not ISM bands. 315 MHz is commonly used instead of the European ISM 433 MHz, though 315 MHz is not an ISM band. In Europe, CE marked equipment can use the 868 MHz band lying between GSM and UHF TV. The USA 902-928 MHz is overlapped by European 872-960 MHz Mobile bands (formerly GSM only). Per July 2012 Japan (ARIB) has adjusted its RFID regulations by changing the country’s ultra-high frequency (UHF) range to 920 MHz. This new spectrum closely matches that of the United States’ 915 MHz band. RF frequencies and standards commonly used for wireless medical product design. The selection of a specific radio-frequency (RF) standard highly depends on the product’s intended use. Many medical device design teams adopt standards within the industrial, scientific, and medical (ISM) bands as the basis for new products. Communication modalities in these bands include all variations of 802.11a/b/g/n, in addition to Bluetooth, ZigBee and RFID. Wireless Medical Telemetry Services (WMTS) bands In response to growing concerns about electromagnetic interference (EMI) from a variety of other licensed radio users such as emergency medical technicians or police, the Federal Communications Commission (FCC) has created the Wireless Medical Telemetry Service (WMTS) for remote monitoring of a patient’s health, including devices to measure patients‘ vital signs and other important health parameters. WMTS is approved for any biomedical emission appropriate for communications, except voice and video. Allocated frequency bands: 608–614 MHz, 1395–1400 MHz and 1427–1432 MHz Medical Implant Communications Service (MICS) bands The Medical Implant Communication Service (MICS) is an ultra-low power, unlicensed, mobile radio service for transmitting data in support of diagnostic or therapeutic functions associated with implanted medical devices. In 2009, the FCC created the Medical Device Radiocommunications Service (MedRadio), incorperating the original MICS bands. MedRadio spectrum is used for diagnostic and therapeutic purposes in implanted medical devices as well as devices worn on a body (e.g. implanted cardiac pacemakers, defibrillators or neuromuscular stimulators that help restore sensation, mobility, and other functions to limbs and organs). Allocated frequency bands: 401–406, 413–419, 426–432, 438–444, and 451–457 MHz Country-specific licensed bands Devices using these bands are typically proprietary, implying that no interference from other users of the band can impair the system. However, the drawback ist that operators are only allowed one quarter of the band for one installation. Moreover, the use of these bands has not been internationally agreed to. Because of this, in addition to WMTS, many medical device manufacturers concentrate on ISM bands such as 902-928 MHz, and, more typically, 2.4-2.5 GHz, often using IEEE 802.11 or Bluetooth® radios. Standard Frequency Data Rate Inductive Coupling < 1Mhz 1-30 Kbps <1m Wireless Medical Telemetry System 608-614, 1395-1400, 1427-1429.5 MHz > 250 Kbps 30-60 m 250 Kbps 2-10 m Medical Device Radiocommu- 401-406 MHz nication (MICS) Medical Micropower Networks 413-419, 426-432, 438-444, (MMNs) 451-457 MHz Range <1m Medical Body Area Networks (MBANs) 2360-2400 MHz 10 Kbps-1 Mbps <1m 802.11a Wi-Fi 5 GHz 54 Mbps 120 m 802.11b Wi-Fi 2.4 GHz 11 Mbps 140 m 802.11g Wi-Fi 2.4 GHz 54 Mbps 140 m 802.11n Wi-Fi 2.4 - 5 GHz 48 Mbps 250 m 802.15.1 Bluetooth Class I 2.4 GHz 3 Mbps 100 m 802.15.1 Bluetooth Class II 2.4 GHz 3 Mbps 10 m 802.15.4 (Zigbee) 868, 915 MHz, 2.4 GHz 40 Kbps, 250 Kbps 75 m World Interoperability for Microwave Access (WiMax) 2.4 GHz 70 Mbps (fixed), 40 Mbps (mobile) © CETECOM Group 2014 | Contact: [email protected] | www.cetecom.com Several km
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