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Bluetooth: The future of wireless medical know-how? | 3M0-700 practice test and Questions and Answers

at the start published MDDI February 2002

medical ELECTRONICS

a new expertise that borrows from telemetry, IrDA, and 802.11 is determined to continue the instant trend.

William E. Saltzstein

medical machine designers now have a few instant options for his or her products. No single instant expertise meets all design goals and addresses all the considerations introduced to designers. For every design assignment that comprises instant expertise, choices must be made to determine most the acceptable technologies for that software and device-use model. for many purposes, Bluetooth wireless expertise might be the most appropriate choice.

Bluetooth, whereas it is on no account the frequent answer to all instant wants, addresses lots of the performance requirements certain to scientific applications, and it's a very first rate fit in use fashions traumatic high mobility, long battery lifestyles, and no infrastructure help. Bluetooth does greater than quite simply get rid of cables; it gives access to a big range of ordinary devices and communications alternate options, together with the formation of small networks. Bluetooth permits further communications hyperlinks by means of providing entry to broad-area networking via cellphone facts communications as well as common Ethernet local-enviornment networks.

the economic, Scientific, and medical (ISM) radio-frequency (RF) band within which Bluetooth operates is shared by way of a couple of wireless applied sciences. scientific instruments must endure immunity trying out for compatibility with other ISM gadgets. because Bluetooth makes use of the bottom transmit vigor of the instant applied sciences, it has the lowest probability of interference. Many companies have examined coexistence considerations among ISM technologies and concluded that there's little trigger for concern in genuine use.

BLUETOOTH: A RELATIVE NEWCOMER

Bluetooth is essentially the most accurate in a string of available instant technologies. IrDA (overseen by using the Infrared machine association), telemetry, 802.11, and home RF all preceded it. every know-how has its personal specific benefits and drawbacks, and Bluetooth borrows from each and every of them.

Bluetooth originated as a cable alternative know-how primarily centered at own, portable computing and communications equipment, corresponding to very own digital assistants, cell phones, and laptop computer systems. The know-how makes possible not best alternative of fundamental aspect-to-element cabling (with minimal impact in can charge and power), however additionally the short and easy advent of small advert hoc networks of gadgets, or piconets.

The Bluetooth specification was created collectively by using Ericsson, IBM, Intel, Nokia, and Toshiba and changed into named after the 10th- century Danish Viking king Harald "Bluetooth" Blatand, who united the warring factions of Denmark and Norway. a main aim of the Bluetooth specification is to create a truly overseas standard to be implemented identically international. up to now, this aim is being met.

nowadays, Bluetooth expertise has a following of more than 2500 corporations. The preliminary founders had been joined through such groups as 3COM, Lucent, Microsoft, and Motorola. products incorporating Bluetooth instant expertise are actually transport from many groups. final 12 months, the Institute of Electrical and Electronics Engineers (IEEE) adopted Bluetooth because the basis for its very own-enviornment community (PAN) regular 802.15.

THE RADIO know-how

As distinctive by means of Bluetooth, the fundamental radio to be used transmits 10 m in open air (despite the fact present implementations function neatly at vastly enhanced range), with an not obligatory power level to allow 100-m operation. With a complete bandwidth of 1 Mb/sec, the radio is designed for reasonable pace and a theoretical 720 Kb/sec payload, dividing up the bandwidth among the devices the usage of information and voice channels. The technology helps eight contraptions on a piconet.

The Bluetooth radio became designed for immunity to noise and for ease of implementation on silicon, with fundamental baseband portions implemented in either hardware or firmware to optimize cost, power, and dimension. Implementations that include the complete radio-frequency and baseband processing area on a single chip—and have few external accessories—are already transport.

To obtain powerful connections, Bluetooth employs three key strategies: frequency hopping, adaptive vigor manage, and the transmission of short records packets. The Bluetooth protocol (for facts) automatically retransmits corrupt data packets that have—because the pseudorandom hopping sequence is designed to maximize frequency spacing between sequential channel hops—most likely hopped faraway from the interfering supply.

Like other ISM radio applied sciences, Bluetooth operates in the 2.4–2.485-GHz radio band. Its radio meets the vigor and spectral emissions requirements defined with the aid of ETSI ETS 300–328 in Europe and FCC beneath CFR forty seven part 15 within the united states the use of the following set of parameters:

Frequency hopping, unfold spectrum seventy nine channels, 1600 hops per second.

Gaussian frequency shift keying modulation with a 1-m symbol-per-2d rate or 1 Mb/sec statistics rate.

83.5 MHz of spectrum divided into 1-MHz channels.

image timing accuracy ±20 ppm timing (when synchronized).

vigour handle in response to acquired sign power depth remarks from the receiving equipment (class 1 requirement).

0 dBm (1 mW) without power manage (class 3, 10-m range).

20 dBm (one hundred-mW) with vigor control (class 1, 100-m latitude).

Bit error cost of 0.1%, receiver sensitivity of –70 dBm.

THE BLUETOOTH INTERFACES

Interfaces turn up in Bluetooth at several diverse tiers (see determine 1). Blue RF is an interface designed to permit reuse and interoperability of the Bluetooth radios. besides the fact that children now not formally a part of the Bluetooth ordinary, it has been adopted by means of most of the silicon suppliers as the digital interface to the radio subsystem.

Baseband processing is accountable for channel coding, decoding, and low-degree timing control and administration of the link for single information-packet transfers. It decodes and encodes packets of statistics and offers the "care and feeding" of the RF transceiver sections.

The hyperlink supervisor is chargeable for managing the link manage states used to establish and preserve the connection between the grasp machine and its slaves, and it contains:

Inquiry/inquiry scan (used to locate other devices; the baseband part of carrier discovery).

page/web page scan (used to establish connections to a selected gadget).

Connections: the active states and the power-saving states of hold, sniff, and park.

The host control interface (HCI) is a hardware and software interface precise to allow modular implementations of the lower-level hardware and baseband. Architecturally, HCI enables the burden of the protocol stack to be borne by the host device or computing device to decrease total implementation cost. Its hardware interface is special as both USB or UART. (the use of USB always achieves the optimum records rates.)

The low-level protocol is responsible for packetization, multiplexing, and demultiplexing packets for the larger-stage protocols, and it maintains order in the piconet; this interface is practically Bluetooth's "traffic cop."

higher-level Protocols. higher-degree protocols such as RFCOMM and service discovery protocol (SDP) deliver excessive-degree performance upon which profiles are constructed. RFCOMM emulates full "hand-shaking" serial ports and is used in profiles that guide fundamental connections between pairs of contraptions. SDP is described later in this article.

Transmission Channels. Two styles of transmission channels are defined in Bluetooth: asynchronous communications hyperlink (ACL) and synchronous connection oriented (SCO). ACL channels are used for records communications and are set up between each two Bluetooth devices for use in connection management. ACL is a packet-switched transmission formulation that offers error detection, ahead error correction, packet monitoring (numbering), and packet retransmission. It offers wholly error-free hyperlinks to the utility; they are going to both provide good facts or preserve making an attempt until signaling that the link is broken. (The retransmission of records in the presence of interference raises latency and slows down net data rates.)

Used for the transmission of voice statistics, SCO is a circuit-switched transmission formula that gives normal latency and guaranteed transmission quotes, and it features error detection and ahead error correction. every SCO channel is given time slots which are predetermined in the transmission sequence, with a optimum of three SCO channels approved in every piconet. Little bandwidth is left for ACL data when all three SCO channels are getting used.

SCO and ACL channels permit option of each packet length and the amount of forward error correction. These parameters are sometimes instantly controlled and rely upon the quantity of interference immunity and statistics throughput needs.

Piconets and Scatternets. A Bluetooth piconet contains as a minimum a grasp and a slave; this pairing is described as a degree-to-element connection. A full piconet consists of one master and as much as seven slaves. The grasp controls all timing including the clock and hopping sequence (to which all slaves synchronize). each and every master will have a little distinctive clock (skew) and hopping sequences, which might be in keeping with the grasp's machine handle (a forty eight-bit IEEE handle). These modifications allow for diverse piconets to be centered and used in the same physical space. A Bluetooth master is chargeable for controlling all statistics traffic in a piconet. All information transmission goes through the master in a star community topology.

The Bluetooth specification defines the capability to change the grasp and slave relationship between two gadgets: a desirable feature for implementation of LAN access facets. It additionally allows a tool to be each a grasp on one piconet and a slave on a further, or to be a slave on multiple piconet if the hardware and baseband implementations support it.

A scatternet is fashioned from two or greater piconets that share a typical member. This shared member may also either be a slave on each piconets, or a master on one and a slave on an additional. each and every of these configurations has architectural trade-offs, and the present Bluetooth specification (1.1) doesn't outline the preferred one, nor does it completely outline the operation of scatternets.

Profiles. Collections of features and features required to operate a particular operation are known as profiles. The primary, required profile offers all contraptions some degree of interoperability—the capacity to feature automatically with different devices with little person intervention. This assortment of services is referred to as the well-known access Profile.

additional, not obligatory profiles rely upon the utility requirements and implementation details. below is an inventory of the profiles presently special. below construction or within the free up technique are profiles for printing, palms-free, and audiovisual applications; human interfaces; and others. The edition 1.1 profiles are

universal access—carried out in all contraptions.

provider Discovery—enables devices to investigate capabilities of alternative gadgets.

Cordless Telephony—covers capabilities for cordless telephone handsets, each audio and dialing.

Intercom—enables voice connections and calling between two contraptions.

Serial Port—comprises the features and strategies required for setting up a virtual serial connection between two devices; it is used in many of the better-stage profiles.

Headset—sets forth the services necessary to enforce a hands-free headset for cell phones and computers.

Dial-Up Networking—covers the features and techniques required to set up a faraway information superhighway connection.

FAX—specifies instant ship and receive signals for faxing.

LAN access—permits Bluetooth to be used because the transport to a common local-enviornment network (LAN).

usual Object exchange (OBEX)—specifies a way to transmit high-level objects, such as info. The foundation for here three profiles, OBEX changed into developed for IrDA and enables Bluetooth for use by way of utility purposes developed for IrDA.

Object Push (OBEX based)—transmits named objects containing records.

File transfer (OBEX based mostly)—transfers data between instruments.

Synchronization (OBEX primarily based)—synchronizes applications on computers, personal digital assistants, and cell phones.

KEY BLUETOOTH features

Bluetooth has been designed to facilitate setup of small organizations of contraptions. Two key points, provider discovery and ad hoc community support, additionally play essential roles in the design, and security facets protect the privacy of communications.

service Discovery Protocol. service discovery protocol (SDP) points enable for automatic cognizance and configuration between two gadgets of differing kinds and from diverse manufacturers.

There are two kinds of discovery within the Bluetooth specification. equipment discovery permits one device to query devices within latitude and purchase, in flip, key advice about their popular capabilities. This key guidance contains full address, human-readable name, and time-honored equipment category (cellular telephone, desktop personal desktop, headset).

provider discovery enables a device to be taught the details of supported profiles and to in reality browse these profiles to learn how to access definite facets. The carrier discovery concept allows for for even more information and entry learn how to be exchanged.

advert Hoc Networks. ad hoc networking is the skill to straight away establish and dissolve small businesses of gadgets with little or no person involvement and no everlasting address task. a couple of gadgets set up one community and preserve the relationship best for the favored time of interplay. If security is preferred, users can type in passwords or very own identification numbers (PINs) for bonding and encryption.

safety. Bluetooth supports several security aspects, reckoning on the software and consumer requirements. These aspects range from the coverage towards eavesdropping inherent to the frequency-hopping unfold-spectrum technology, to the use of keys or PIN and password combos. With using PINs (alphanumeric strings of up to sixteen characters), the 128-bit SAFER+ encryption algorithm is used to create very strong security and encryption between devices. more protection can also be introduced at the application level if preferred. This implementation should still meet the necessities of systems that must conform to the medical insurance Portability and Accountability Act of 1996 privateness specifications.

BLUETOOTH'S medical functions

Bluetooth expertise opens up many percentages for scientific devices to speak and facilitate healthcare providers' access to fundamental assistance. a few studies are being carried out, many of them in Europe, to evaluate the technology as a method for synchronizing personal contraptions and transferring statistics in hospitals. at least one scientific equipment has been listed on the Bluetooth internet web page as a Bluetooth-approved product. other gadgets developed by using two companies have been proven, and are serving as feasibility prototypes for Bluetooth implementation. These encompass a patient-worn pulse oximeter and a transportable affected person monitor.

scientific information. Use of handheld and cell computing technology in the clinical container has stepped forward frequently. docs mechanically access scientific databases for drug dosages and interactions. domestic-fitness nurses keep suggestions on their sufferers for box use. Many other purposes are enabling practitioners to make more advantageous-suggested decisions.

Bluetooth wireless expertise will permit scientific instruments to connect greater easily with each other and to information access features provided via LANs. Bluetooth's low power, affordable, and few configuration requirements might be traded off in opposition t 802.11b's better speed and simple business integration. The use model and atmosphere for each individual utility will check the best option for instant statistics know-how.

clinical devices. different unique percentages exist in the field of medical gadget communications and networking. Bluetooth obviously offers an potential for tremendously mobile battery-powered gadgets, and it opens up the probability for these instruments to hook up with a LAN or vast-enviornment network. input, output, and storage will also be faraway from particular person instruments and centralized to raise flexibility and in the reduction of the gadgets' can charge, size, and power. devices also can seek advice from each and every different within a patient-area network, if you want to make them less liable to clinical blunders.

The challenges to integrating Bluetooth in clinical devices are discussed in stronger aspect beneath, however they are the same as for any RF know-how used in medicine. Bluetooth has the talents of being an adopted and managed trade typical with an extensive qualification, verification, and approval procedure to make sure compliance with that specification.

Implementation. When a tool brand decides to contain Bluetooth into its scientific product, it should proceed thoughtfully. most likely the easiest way to get started is by using an external adapter to prototype the device design, profit a greater knowing of issues associated with the implementation, and bring together constructive consumer and advertising and marketing feedback. This method might also shorten time to market.

When the prototype is up and running and a brand is in a position to navigate the make-versus-purchase choices, it is going to need to accept as true with a few considerations because it formulates its product and venture plans.

The $5 answer. there was a lot dialogue within the media about the so-called $5 Bluetooth solution, and some businesses claim to have accomplished this greenback volume per unit for high-volume shipments in 2002.

The industry goal of $5 contains simplest the RF and baseband signal processing services. To put into effect the complete Bluetooth performance from the baseboard layers to profiles and utility requires external add-ons (at the least an antenna or board house for an onboard implementation, and often other discrete components), as well as RAM, ROM, and processor bandwidth. additionally, the entire latest Bluetooth software stacks that enforce more than the headset profile require an operating device.

The $5 purpose assumes that a device, such as a cellular telephone, already has sufficient of the above elements and an working device. It assumes a royalty-free implementation of the Bluetooth software stack, which isn't the case unless a tool company implements the somewhat complex specification. The goal also assumes construction volumes within the hundreds of thousands of contraptions per 12 months.

unluckily, very few of the above situations are met for clinical contraptions, so implementations in additional-practical reduce volumes are not going to meet that charge aim. practical estimates for scientific machine functions for the next year latitude from $25 to $70 and would require gigantic building components. options requiring little or no construction charge extra however yield quick time to market and can be the superior option for low-extent creation runs, or unless customer acceptance justifies incredibly integrated options.

RF accessories AND concerns

Most medical gadget manufacturers have huge experience, always poor, with RF. traditionally, a superb amount of both time and cash are spent trying to in the reduction of RF emissions and susceptibility. Bluetooth know-how transmits and receives RF indicators, which require quite a different ability set.

ANTENNAS

happily, many astounding designs can be found for Bluetooth that consist of all of the RF add-ons, as a result getting rid of this part of the design assignment. The top-rated Bluetooth RF transceiver will feature poorly, youngsters, if the design and site of the antenna are not noted. The antenna has to be discovered in or on the gadget to restrict RF shadowing outside shielded instances and accessories. It also needs to be designed with the acceptable benefit and radiation trial for a specific application and its placement in the gadget. commonplace 2.four-GHz antennas can be found from a couple of suppliers and present many options for placement, sample, benefit, and physical mounting. Board-mount types are available if the enclosure is radio-transparent and the radiation pattern is appropriate for the software. it is essential to observe that plastic fabric alternative could make a change for embedded antennas because these substances vary in their transparency at 2.4 GHz.

application assist for Host Stack. Many scientific equipment manufacturers will now not want or be in a position to manage to pay for a totally integrated answer that eliminates the HCI and merges the baseband and host processing for his or her instruments. In most instances, designers will use a module that comprises the baseband and RF, as well as a Bluetooth utility stack of their host software. depending on the type and variety of profiles supported (i.e., the volume of functionality required), a clinical device's Bluetooth utility stack would require:

32–sixty four KB of code house.

sixteen–32 KB of RAM.

approximately 5 thousands and thousands of instructions per second of processor bandwidth.

(These approximations symbolize a regular of a couple of suppliers'requisites.)

RF issues. The three RF questions most commonly asked about Bluetooth and clinical contraptions are: How will it affect the human body? How smartly will it work with different clinical contraptions and items used in the domestic and health facility? How smartly will it work with other applied sciences on the ISM band?

Human physique exposure. a few companies modify RF exposure tiers, and papers have been written related to RF's results on the human body. most of the reports which have been completed for 802.11b are additionally relevant to Bluetooth.

trying out achieved to this point suggests no damage from RF stages utilized in 802.11b and Bluetooth. Most physique-worn or portable devices will likely be designed as category 3 Bluetooth contraptions (1 mW), which might have tremendously much less power than many of the transmitters established (at 100 mW) and are even much less more likely to have any deleterious outcomes.

clinical machine interference and sensitivity. The ISM band is greatly outside the frequency latitude of naturally happening organic indicators; hence, the capabilities chance of interference to that sign is low and would turn up from outcomes on the accessories in a selected machine design. as a result of Bluetooth is a extremely low vigor transmitter, it's not likely to intervene. Most scientific gadgets, including implantable devices, ought to be tested for susceptibility in the ISM band.

Microwave ovens and some different devices that may well be found in clinical settings use the ISM frequency band. Microwave ovens were found to pose no interference complications, and different instruments using ISM-frequency radiation are smartly shielded to avoid interference with other instruments.

Coexistence in the ISM band. clinical gadget companies and regulatory corporations, because of their experiences with health facility telemetry techniques, have a heightened sensitivity to the issues of interference and coexistence. Their concerns are legitimate since the hospitals they provide may have already got installed instant LANs, and distinctive ISM radios could exist in different environments as smartly.

testing carried out by using a number of organizations has shown that besides the fact that children performance degradation happens as a result of interference, the true-world outcomes of interference are manageable via existing functions. extra work is integral by using the wireless trade to eliminate this subject, however thus far interference doesn't appear to be a significant challenge in most fashions.

For the future, the technologies specification agencies (the Bluetooth SIG and the IEEE 802.15) are working toward interoperability solutions that would eliminate the RF considerations absolutely.

THE REGULATORY side

Three essential regulatory approvals for instant medical contraptions within the u.s. are these of Bluetooth, FDA, and FCC. Bluetooth approval is new for clinical gadget manufacturers, and instruments with out instant add-ons have historically been exempt from FCC approvals in most situations. The FDA approval technique is difficult, certainly when new applied sciences are being introduced.

Bluetooth Qualification. The Bluetooth qualification method is neatly-described in SIG documentation. Bluetooth technology keeps a strict enforcement coverage. For businesses to profit free license to the intellectual property that the SIG individuals have contributed, the products need to move the applicable qualification manner earlier than they're offered (see sidebar). once certified, the product may additionally then screen the Bluetooth company, emblems, and labeling.

The qualification procedure is meant to ensure customers and users a high stage of interoperability between devices. it is taken quite significantly and appears to be helpful, to decide from a sampling of items that meet the latest edition 1.1 specification. (past types had interoperability problems, which were addressed in 1.1; producers should be cautious of products certified to earlier specification revisions.)

The Bluetooth qualification software permits accessories to be certified to quite a lot of tiers. Hardware and software add-ons can also be certified so that a device manufacturer can integrate them into a tool without needing to repeat the component of the trying out the element has passed. This capability that if a device brand integrates a whole certified OEM module into a tool, that brand don't need to do any extra testing to be certified for Bluetooth. different combos of certified accessories have distinct units of implications, so it is critical to consider what qualification work could be required when evaluating no matter if to make or purchase.

As of this writing, there are five identified Bluetooth qualification their bodies in the u.s. and 26 international liable for reviewing the entire look at various outcomes and documentation. furthermore, there's one recognized Bluetooth qualification check facility within the united states and four international that can do finished trying out and submission. Many compliance trying out homes have or can have the ability to perform checking out and create packages for submission to those bodies sooner or later.

FDA. counting on the implementation and use of Bluetooth, there are a number of approaches to gaining approval from FDA and overseas businesses. Readers may still notice that these are abilities paths best and ought to be reviewed and accredited via particular person producers' regulatory affairs workforce.

If Bluetooth instant expertise is added to a tool as an exterior adapter with no adjustments, comparable to alternative of an existing RS-232 cable, and the machine is accepted for data communications capabilities through that port to exterior device, it could be feasible to make use of the regulatory approval strategy taken by means of many device organizations with exterior modems. If there is not any alternate in labeling or meant use it could be least expensive easily to make use of what is called a "letter to file." The Bluetooth adapter can be considered a instant modem in this case, assuming that every one other acceptable business approvals and qualifications had been completed.

The regulatory company may still be informed that Bluetooth instant technology is a part of an in depth business average with tightly enforced qualification and compliance checking out it really is required for listing of a product. Documentation from the Bluetooth qualification look at various facility and Bluetooth qualification physique deliver proof of this compliance verification. The posted specification and examine methods documents are tightly managed via Bluetooth SIG Inc., a U.S. service provider centered for that intention.

If Bluetooth is included internally within a device, submission of a 510(ok) software to FDA is required, certainly as a result of application and hardware changes are likely to be worried. it is within your means to expect that such 510(k) submissions have been made or could be made in the close future. the key, as with all 510(k) submissions, is to establish predicate devices and applied sciences to make use of within the submission.

wireless and telemetry contraptions were delivery for a long time within the u.s. and worldwide. devices the usage of wireless technologies are at the moment being marketed on the wireless scientific telemetry equipment band within the u.s. that makes use of frequency-hopping unfold-spectrum applied sciences as well as traditional frequency modulation expertise. potential predicate gadgets the use of 802.11 frequency hopping know-how in the ISM band had been cleared via FDA and are at present being marketed and disbursed.

authorised and smartly-proven accessories that have a fine track checklist as exterior adaptors can be simpler to research one after the other, and convincing regulatory agencies that they are protected and reliable may be less of a battle. The external approach will additionally permit trying out and gathering of scientific and customer usage information to be included with a submission.

FCC. FCC checking out and approval are relatively normal prac- tice in the telecommunications industry, but FCC has not regulated scientific contraptions to date. once Bluetooth is introduced to a device, however, FCC checking out turns into mandatory because the equipment turns into an intentional radiator. Bluetooth RF modules had been designed for FCC compliance, which may still permit them to flow the applicable checking out if the modules are appropriately integrated into products.

a potential risk to FCC compliance for designs the usage of pretested add-ons comes from inside techniques' emissions that are coupled into the Bluetooth RF and are reradiated by means of the Bluetooth transmitter and antenna. FCC testing can also be carried out by the same verify homes presently used for IEC emissions and susceptibility testing for medical gadgets.

CONCLUSION

Bluetooth instant expertise poses new questions about which ingredients of the technology may still be purchased and which materials may still be designed in-house. businesses should cautiously weigh the Bluetooth requirements towards the equipment components in terms of materials, together with both hardware and utility. Bluetooth qualification and FCC regulation ought to be considered in the challenge plan. The level of in-apartment expertise should be considered as neatly.

it's handy so as to add up individual accessories on a constituents-charge foundation and arrive at a low-price solution, however using such a way can produce a disastrous effect when the real prices of engineering and qualification are absolutely realized. deciding to buy a more robust-priced, incredibly integrated solution might keep titanic nonrecurring-expense expenses and reduce time to market, which offsets the better expense for an entire product era. producers may still be careful to take into account the precise building fees and time table, and how the two can affect revenue calculations.

It is apparent that medical devices and medical information administration items will advantage from the benefits provided through Bluetooth wireless know-how. And however Bluetooth certainly gifts new challenges to the clinical equipment trade, the merits stand to be somewhat gigantic in both current and future use models for medical products.

BIBLIOGRAPHY

Bray, Jennifer, and Sturman, Charles F. Bluetooth join without Cables, 2nd ed. Englewood Cliffs, NJ: Prentice-corridor PTR, 2002.

William E. Saltzstein is president and founding father of Code Blue Communications, a corporation primarily based in Redmond, WA, that has been developing Bluetooth technology.

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