Medical Ultrasound Exposure Measurements: Update on Devices, Methods, and Problems Gerald R. Harris FDA, Center for Devices and Radiological Health, Rockville, MD 20850 Absfrac!- Medical ultrasound fields span a wide range of exposure conditions, from the continuous, low-frequency vibrations of surgical fragmentation needles, to the intense, broadbandpressurepulsesproducedbyextracorporealshock wave lithotripters. Each of these diverse conditionsof use presents its own exposure measurement challenges. Furthermore, the sensors and techniques used to evaluate ultrasound exposures have had to evolve as new or expanded clinical applications have emerged. In this paper some ofthe morenotableofthesedevelopmentsarepresentedand discussed. Topics covered include recent work on devices and techniques, methods of calibration, progress in standardization, and current problem areas, including the effects of nonlinearpropagation.Emphasisisgivento miniature hydrophones because of the prominent role they continue to play in ultrasound exposure measurements. I. INTRODUCTION 11. DIAGNOSTIC IMAGING AND DOPPLERTO 15 MHz Diagnosticultrasoundexposimetryhasreceivedmore attention thatany other medical use category, paralleling the success of diagnosticultrasound as amedicalimaging modality. New and refined measurement approaches have appeared with some regularity, as have problems associated withcharacterizingtheultrasoundfields. To emphasize where these developments seem to be most applicable, the discussion of diagnostic ultrasound has been separated into two frequency ranges, the higher range being covered in the next section. The choice of15 MHz is somewhat arbitrary, although this frequency has been used to define the of range applicability for several International Electrotechnical Commission (IEC) standards discussed below. A . Nonlinear propagation effectson p , measuremen! Forhydrophone-basedmeasurements, the presence ofnonlinear propagation effects poses a serious impediment to the accurate assessment of ultrasonic exposure [a]. An As the medical uses of ultrasound have grown, so has the need for quantifying the acoustic field variables thatdefine obvious first consequence is that the harmonics generated anincreasedmeasurementbandwidth.Aless the extent of exposure. Added demands have been placednecessitate on apparent result is that for a distorted pulsed waveform, the the measurement devices as well. For example, increased bandwidth below the center frequencyof the pulse mustbe bandwidths are necessary to faithfully reproduce the acoustic extended as well, particularly for accurate measurement of pressures associatedwithnonlinear wave propagation orhigh the peak negative pressure, p,[7], [g]. One reason is that the frequency applications; small detector size must be achieved shorter the pulse, the broader the specmm below as well as to measure highly focused or high frequency fields, or to make measurementsin vivo; robust devicesor techniques are abovethecenterfrequency.Additionallyforp,,the waveform asymmetry resulting from the combined effects of in required to withstandtheintensefieldsencountered sourcediffractionandnonlinearpropagationcausethe lithotripsyandfocusedsurgery;andefticientmeansare portion of thepulsedwaveformwherep,occurs to be needed to characterize the acoustic output in the complex dominated by low-frequency components. The accuracy of scanning modes found in modem diagnostic imagers. the Mechanical Index (MI) decreases as well, because it is In this paper some of the more recent developments defined as the derated peak rarefactional pressure, measured inmedicalultrasoundexposimeCry arepresented. For under specified conditions, divided by the square root the of background on fundamental measurement techniques, centerfrequency (fJ [9], [IO]. From [7] and [g], which instrumentation,andstandards, as well as definitions of contain both simulations and measurements ofthe effects of [l], [2], [3], [4], terms and concepts, the reader may consult [5]. The paperis organized by medical application category. bandlimited response onp, and MI, it is seen that to reduce errors to less than 510%. the hydrophone-amplifier Within each section, problems associated with the clinical bandwidth should extend at least an order of magnitude device or withmeasurement of therelevantexposure belowthepulse center frequency.Currentmeasurement quantities are identified, and the instruments and methods standards require that the hydrophone-amplifiercombination thathavebeendeveloped to addresstheseproblems, or have a bandwidth with lower comer frequency of fJ2[l l], simply to improvecurrentmeasurementpractice,are [12], although in [l I ] it is recommended that this value he described.Also,progressinmeasurementandlabeling decreased to fJ20. standardizationisbrieflydiscussedwhereapplicable.A Because of this result,at a minimum the combined short description of in vivomeasurementsconcludesthe frequency response of all components used to condition, presentation. U S . Government work not protected by U.S. copyright 1999 IEEE ULTRASONICS SYMPOSIUM - 1341 the SI increases. TheSI is a field quantity rather than a beam amplify, or recorddiagnosticpulsedwaveformsshould descriptor likea,, and as such may be calculated at any field extenddown to approximatelyfJ20.Inaddition,needle location from a single hydrophone measurement. In practice hydrophones should be used with caution, because of the roll-off in low-frequency response that has been observe in d the upper integration limit is chosen to reduce errors from high-frequency spectral noise (25MHz was usedin [25]). In thesedevices[13],[14], [IS], 1161, [17]. Tbisroll-offseems to he relatedto diffraction at the needle tip, and at least one [2S] it was found that the SI tracked fairly linearly withom, modifieddesignhasbeendeveloped to amelioratethis beingnumericallyabout a factorof IO lower. Thus,a problem [IS]. A related issue is the need for low-frequency thresholdvalue of 0.0.5-0.1 forthe SI seemed to be calibration standards, and in this regard several methods areappropriate for demarcating the quasi-linear region, but this concept needs further study. heingconsidered, includingthree-transducerreciprocity[13], interferometry [13], time delay spectrometry (TDS) [16], m [ 171 and broadband pulse[ l S]. SI = ! P ( f ) d f f P ( S ) d f 1 6 (1) B. Nonlinearpropagation efects on derated quanlities Medical ultrasound fields usually are measured in Acousticattenuators: It hasbeenproposedthat water, and one international standard specifies that outputs low-densitypolyethyleneattenuators be placedinthe must be declared to the user in that form [19]. In the US, ultrasoundbeambetweenthesource and hydrophone to standards for diagnostic ultrasound equipment have been simulatean in situ exposure[26],[27].Theattenuation published that define acoustic output quantities in which a coefficient of thismaterialhasafrequencydependence derating factorof 0.3 dB cm-lMHz.’is applied to estimatein similar to that of soft tissue, and the acoustic impedance is situexposurevalues[g], [ll], [20].Forcomputational approximately 25% greater than that of water. The simplicitythisderatingprocessassumesthatultrasound procedure recommended involves first measuring a, and fc propagationislinear,butmostdiagnosticscannerscan inwateratthelocationwherethe in situ value is to be produce output levelsin which nonlinear propagation effects determined. Then the attenuator thickness is chosen so that are significant, not only in water but in tissue as well [6]. A its attenuation matches that of the desired tissue type. If a, problem arises because nonlinear propagation can lead to < 1, the attenuator is placed in the beam next to the source acoustic saturation, in which an increase in source voltage is transducer and the hydrophone measurement is made.a,If not accompanied byan equivalent increase in field pressure. 2 I, an additional measurement is made with the attenuator Attenuation in the propagation medium tends to counteract movednext to thehydrophone,andthe two resultsare this effect, so saturation is relatively more pronounced in averaged. While this technique has advantages, it has not water than in tissue. Thus, a derated quantity calculated from been widely evaluated. a hydrophone-measured pressure at full output in water can Tissue mimicking materials: An obvious but to date lead to a significant underestimateof that quantity in tissue difficult approach for obtaining accurate estimatesinofsitu 1211. Severalapproachesarebeingstudied to dealwith exposure values when nonlinear conditions existtoismake this phenomenon. measurements in a material that simulates of allthe relevant Linear extrapolation of low-outputlevels:One properties oftissue, including attenuation. Recent work with proposal for making estimates of in situ exposures from atissue mimickingliquid hasbeen reported inwhicha water-based hydrophone measurements in the presence of 60140 mixture of deionized water and evaporated roughly nonlinear propagation isto perform a linear extrapolation of milk was used, along with a small amount of preservative derated “small-signal” measurements; i.e., measurements at [28]. At room temperature (22°C) the material had a speed source output levels in the linear regime [22]. To define this of sound of 1526 d s , a density of 1.03 &c, an attenuation small-signal, quasi-linear region, it has been suggested that coefficient of 0.27 dB cm-’MHz-’,andanonlinearity a value of shock parameter a < 0.5 be used [D]. One such parameter (B/A) of 5.7. Theattenuationcoefflcientwas parameter used for focused medical ultrasound beams and designed to match the commonly used derating factor of 0.3 adopted in [1 l], [ 121is the nonlinear propagation parameter, [9], [ 101, [l l]. The other properties area reasonable match am. Calculation of omrequires measurement of the focal to soft tissue. While this and other similar materialsdo not distanceandpressure,centerfrequency,andfocalgain. havetheconvenience,universalavailability,andwellOther,possiblymoreconvenientnonlinearityparameters characterizedproperties of water,theyarevaluablefor have been introduced [24], [25]. In[25] afrequency domain evaluating errors that may be introduced in making in situ estimator of nonlinearity, the spectral index (SI),is defined exposureestimatesusingderatedwater-based measurements. (seeEq. (I)). Here P(f) isthepowerspectralvalueat Also, they provide amedium for experimental verification of frequency f, and f6 is the frequency above f, at which the various theoretical models that have been developed that spectrumfirstfalls 6 dB belowitsvalueat F,. Asthe include the effectsof diffraction, attenuation, and nonlinear measured hydrophone waveform becomes more nonlinear propagation on the radiated field. and generates more high-frequency harmonics, the value of 1: 1342 - 1999 IEEE ULTRASONICS SYMPOSIUM change in n, which is integrated over the path of interaction The abilityofmodern diagnostic scanners to operate of the light and sound. For small pressure variations, the local instantaneouschange in refractiveindex is proportional not only with multiple focal zones, but in several modesat to thepressure,theproportionalityconstantbeingthe once, has madedeterminingthepeakvalues of acoustic adiabaticpiezo-opticcoefficient, K. Thus,withpasthe quantities a challenging task, especially I, [29]. Many acoustic pressure, operator control settings alter the location of the maximum values,andgenerallynotinaneasilyidentifiableway. (2) v=kKJpdl. Several approach have been takento alleviate this problem. Establishing measurementprotocols: As a start to Thelightintensityinthescatteredbeamis a determining the control settings that lead to a maximum function of v, and this relationship has beenforused rapid 2state, a systematic approach for stepping through the process ofmeasuring I, has been proposed for B-mode [30], [31].D mapping and visualization of the ultrasonic field pattern fieldscanbe The protocol involves, among other things, looping throughusingaCCDcamera[35],[36].Pulsed measured by proper synchronizing of the light and changes in focal position, number of foci, and depth of field. ultrasoundbeams.Thefielddistributionintheresultant The flow chart format is designed to reduce measurement optical imagerepresents integratedpressure, so tomographic that the maximum IsPTA has time while increasing confidence reconstruction has been used to obtain the pressure been located. Others have used this procedure with some dismbution by making multiple optical measurements at a success,butinitsimplementationtheimportanceofan series of angles through the ultrasoundbeam.Theoptical inductive coil pick-up for reliable triggering of the acoustic system in [35]uses schlierenimaging(withzerothdiffracti0n pulse measurement system was noted, not only for providing the3-Dpressure a trigger, but also for providing information about pulse and ordersuppressed), andreconshuction yields amplitudedistribution,fromwhichIsPTAandultrasonic frame timing [32]. It also was mentioned that a way to avoid triggering difficultiesis to measure untriggered hydrophone power canbe derived. In [36] the instantaneous perturbation ofn (and pressure per Eq. (2)) is found via optical processing output with an RF power meter to obtain the I,,,, as has in whichan iterative algorithm recoversthe integrated phase been described previously (pp. 140-145 in [l]). change at instant t, from measurements of optical intensity in Measurement via hydrophone arrays: As an two planesbeyondthesoundfieldandnormaltothe additionalaidtofacilitatingmeasurementsinscanning modes, both l-D and 2-D hydrophone arrays are being used direction of optical wave propagation. After reconstruction the result is p(x,y,z)at ti, and the complete field p(x,y.z,t) is [33], [34]. The l-D array systemcontains a PVDF obtained by varying t,. (This result may be compared to a 2 I elementsof0.4 mmdiameter membrane hydrophone with which p(t) is measuredatpoints and 0.6 mm spacing. The -3 dB bandwidth is approximately hydrophonescan,in 23 MHz. Scanning mechanics and processing and control (X,,YpZk).) In addition to its ability to provide rapid 2-D beam electronicsandsottware are included.Upgradesfroma previous design include the ability to transfer acoustic output plots (albeit of an integrated field quantity), advantages of this technique are its inherently non-perturbing nature and datainASCIIformat,areductioninnoiseequivalent goodspatialresolution (< 0.1 mm).Asthepressure 100 MHz A-D converter. A and a new to 1 kPa, pressure amplitude increases, the validity of Eq. (2) diminishes, a RF power meter as the of an addition is interfacing planned mentioned above to make easier the identification of systemconsiderationthatapplies to some of thehigheroutput settings that result in maximumIsWC The more recent 2-D therapy and diagnostic applications. In these large amplitude ofthe field have been made using array uses a vinylidene fluoride copolymer membrane withcases useful optical images the higher orders of diffracted light [37], but the relationship 64 (8x8) elements having0.2 mm-diameter elements and a between light intensity and pressure needs fiuther study. 1 mm spacing. A -3 dB bandwidth of > 30MHzanda combinedacoustic-electroniccrosstalk of -30 dB are D. Temperature rise phantoms reported. Thethermalindices(TI)oftheOutputDisplay Measurement acousto-optic via dt@raction: Another approach that has been used as an efficient means to Standard [g], [IO] have been in use since 1992. While they obtain ultrasound field distribution measurements employs have proved useful as a predictor of thermal risk during ultrasound procedures, they are based on the phenomenon ofacousto-optic diffraction (pp. 143-162 indiagnostic theoreticalmodelsratherthanactualmeasurements of [3]). When ultrasonic pressure waves propagate in temperature rise in tissue. Furthermore, to facilitate transparent media, the density perturbations produce implementation of these indices on clinical systems, fluctuations in the optical refractive index, n. A beam of simplifyingassumptionsregardingtissuepropertiesand lightpassingthroughtheselocalinhomogeneitieswill as ameans to experience velocity (and phase) deviations. The total optical beamgeometriesweremade.Therefore, phase shift, v, for a monochromatic light beam is given by evaluate the theoretical models,as well as to estimate tissue from diagnostic ultrasound exposures v=kJ 6n dl, where k is the optical wave number 6nand is the heating C. Measurements in complex scanning modes 1999 IEEE ULTRASONICS SYMPOSIUM - 1343 experimentally,athermaltestobject(TTO)hasbeen conductivity, and the acoustic impedance of the plexiglass proposed 1381. (Note that, strictly speaking, temperature rise absorber. The sensor has been tested for CW beams from 3is notan exposure quantity.)This TT0 comprises a thin-film 17 MHz [44]. The sensitivity over this range varied 10from thermocouple (TFT) positioned between two layers of tissue 30 W,and the timeto reach thermal equilibrium was-13 mimickingmaterial,each4-8mmthickand 50 mm in minutes. Thistime could be reduced by decreasing the diameter. The top surface of the TT0 is protected by a 6 absorber thickness, but sensitivity would be decreased as pm-thickmetallizedmylarsheet.Thebottomsurfaceis well. Also, for measurement of pulsed waveforms, of 2% ethanol coupled to an acoustic absorber by a mixture knowledge of the frequency spectrum is necessary. in water. The TFT was chosen over bulkier thermal F. Intercomparison measurements configurationstominimizeviscousheating due to interaction In Europe two measurement studies on diagnostic between the thermocouple body and the ultrasound beam, fields, each coordinated by a national measurement institute, andthermalconductionalongtheconnectingwires, two have been performed in accordance withlEC61157 [ 191. In artifacts that become significant as the beam dimensions both, a diagnostic ultrasound device was circulated among decrease. The TT0 is scanned in the ultrasound field much palticipating laboratories and the resultscompared, In 1451 as a hydrophone would he. The sensitivity was foundto he 10 groupsmademeasurementsona 5 MHzlineararray 10-16 p V K , with a temperature resolutionof 2 mK. scanner and a check source. It was concluded that the single The advantage of a TT0 approachisthatno mostimportantfactorcontributing to thedifferences in assumptions about the radiated field are made, only the about results was the variety of hydrophone and amplifier systems tissue model. Also, transducer self-heatingis accounted for, used. In 1461 a commercial diagnostic instrument was sent a factor ignored in the TI models. The TT0 in [38] contains to 9 participants. Measurements were restricted to M-mode no perfusion, although it has been shown that perfusion mon aythe3.5MHztransducerused.Whilethemajority of beaccountedforcomputationally 1391. Futureworkis results were in good agreement with one another, significant proposed for comparing temperature risein the TMM with deviations were found, indicating the importance ofperiodic that in tissue both in vitro and in situ, checking of the measurement devices and procedures. E. Measurement ofultrasonicpower 111. DIAGNOSTICIMAGING AND DOPPLER ABOVE15 MHZ Theradiationforcebalance (FWB) andplanar scanning techniques remain the most common methods for High frequency diagnostic applications include measuring the temporal-average power in medical a ophthalmology, dermatology, and intravascular ultrasound. ultrasound beam [l l], [40], [41]. In the RFB measurement, The challenges here have been to improve the spatial and errorsourcesincludeforcesduetotargetbuoyancy, temporal measurement resolution, perform and to streaming, surface tension of target support structures, and hydrophone calibrationsat higher frequencies. external vibration. One RFB approachtominimizethese confounding forces involves modulating the ultrasound and A . New hydrophone designs measuringtheresultantradiationforce at afrequency Both needleand membrane hydrophones have been removed from their influence (20 Hz) (421. Errors of less redesigned for measurements in higher-frequency focused than a few percent are reported for powers from O.lmW-30fields. Thinner films to increase measurement bandwidth, andsmalleractiveelements to reducespatialaveraging W, and frequencies from0.5-30 MHz. Both the RFB and planar scanning methods requireeffects, have been used. To date, needle hydrophones with 9 pm PVDF film and diameters of 0.04,0.75,0.15, and 0.2 a somewhat complex set-up. A simpler technique that has beenproposed,especiallyforroutinecalibrationchecks mm are obtainable commercially. Inthemodifiedneedle mentioned in Sec.1I.A [IS], 4 pm copolymer film was used wherethehighestaccuracyisnotrequired,isbasedon in probe an effective measuring the temperature rise inan absorber placed in the in an ellipsoidal configuration, and one ultrasoundbeam.Thisthermoacousticsensingtechnique diameter of 0.13 mm was measured, along withe a0 . 3 dB response from 0.2-40 MHz. Bilaminar membrane [43] comprisesan ultrasound-absorbing piexiglass disk 1 cm thick x3 cm in diameter. The water-home ultrasound waveshydrophones made from9 pm PVDF sheets are available as impingeuponthefrontfaceofthedisk.Theotherdisk well, one basedon [47] witha 0.2 mm electrode diameter. In surfaces must be thermally insulated, and an air layer has [48] a membrane hydrophone is described in which 37 pma been used in the reported device. A temperature sensor at the diameter spot-poled electrode was formedon a single sheet back face (i.e., the planar Plexiglas-air interface) measures of4pmP(VDF-TrFE)film.Themeasuredeffective diameter was <l00 pm, and the -3 dB bandwidth was 150 the temperature rise, whose steady-state value is proportional MHz. In all of these needle and membrane designs reduced to the powerof the incident ultrasonic wave. Calibration of this thermoacoustic sensor requires knowledge of the sound sensitivity is an important factor, and submersible integral 150 MHz absorptioncoefficient asafunction offrequency, the thermal amplifiers or short cable lengths are required. The 1344 - 1999 IEEE ULTRASONICS SYMPOSIUM bandwidth in this latter device was achievedat the expense down to 25 pm have been reported. An added advantage of of increased noise susceptibility, because only a single layer thismethod is thatthemeasurementscharacterizethe of polymer film was used. The noise canceling feature of a transmit-receive response of the system. However, relating to offset this themeasuredwaveformsandprofiles differential amplifier design has been proposed to transmit-only effect [49], and one such membrane device having0.2amm quantities is difficult, so direct measurements of exposure spot size and 14 dB-gain differential amplifier is available, fields are preferred[l l], [12]. although no comparative test results have been reported. Whenhydrophonesizeguidelinescannotbemet,an alternativeapproach is to performaspatialaveraging B. Hydrophone calibration at high frequencies correction.Thegeneralprocedureis first tochoosea No standardsexistforhydrophonecalibrations theoretical model to describe the acoustic pressure field at above IS MHz, although the IEChasinprocessadraft z from the source radialdistance r andaxialdistance document that addresses some aspects of this topic [50]. transducer (assumed circular). Next, taking the hydrophone Calibration in this range is an active of area study, and some output as proportionalto the average pressure overits active current work is described below. surface, the spatial averageofacoustic quantity Q(r,z) (e.g., The use of laserinterferometry for calibrating pressure) over that surface is calculated (denoted <Q(r,z)>). hydrophones has become standard practiceat some national Then correction factor Cis computed as C= Q(r,z)/<Q(r,z)> measurementinstitutes,andrecentlyextensionofthe = l+&,, 6, being the spatial-average deviation. calibration range to 60-70 MHz has been reported [5 I], [52], A simple approach recommend in an IEC Technical [53]. Both interferometer systems are ofthe Michelsontype, Report [59] assumes a jinc radial beam shape. The most but inone the optically reflective pellicle that is displaced by comprehensive method proposed date, tohowever, the ultrasonic wave is located at the water surface instea of d incorporates the effects of nonlinear propagation into the analysis of the pressure distribution and 6, [60]. In this beingtotallysubmerged.Thestatedadvantage of this to whichthe approach :S thattheopticalphaseshift procedure 6, is expressedas a functionof om and new factor interferometer responds is not affected by changes in the a, = b.&ddd,, where b.wis themeasured(i.e.,spatial refractive indexofwater caused by the propagating acoustic averaged) beamwidth for quantity Q, andde is the effective n wave (see Eq.(2) and discussion). Thus, no correction for hydrophonediameter. In [60] 6, was computedforp,as well as the peak compressional pressure (p,) and pulse pressureis necessary. Inbothsystems,focusedtransducersdrivento squared integral.As an example result,forp, with om = I, 6, produce harmonically rich waveforms via nonlinear increased from~ 5 at % a, =5 to >40% for a, = 1. In general, propagation are used to obtain a sufticient pressure SNRat 6, (or C) is a complex functionof the hydrophone size and work is needed for the higher frequencies, the main problem being the inverse degree of distortion, and more simulation both circular and rectangular fields, as well as experimental dependenccofparticledisplacementon frequencyforagiven verification of results. pressure. For one system the calibration uncertainty (at 95% C.L.) increased from*4.6% at 20 MHz to*25% at 60 MHz. N.EXTRACORPOREAL PRESSUREPULSELITHOTRIPSY Thisprimarycalibrationmethodcanprovidereference hydrophones for use secondary in calibrations via substitution. A. Hydrophone developments The highly focused, large amplitude pressure fields Two other less vetted but still useful methods for high frequency calibration have been reported of late. In produced by extracorporeally induced lithotripsy devices providean efficientmeansforfragmentingurinarytract to that one,thehydrophoneresponsewascompared calculi. To address the characterization and safe use ofthese predicted from theoretical nonlinear field calculations[54], devices, two IEC standards are now available, one covering [S]. Inamoredirectapproach, TDS hasbeenused to calibrate a membrane hydrophone from 1-40 MHz, and the field measurements [61] and theother dealing with labeling maximum difference from an interferometric calibration of and other safety aspects[62]. The field quantities calledfor the same hydrophone was 1.3 dB [56]. include p, and p,. the energyperpulse,andthefocal dimensions. As withdiagnosticpulsemeasurements,the hydrophonesusedfordeterminingthesequantitiesmusthave C. Sparial averagingby hydrophone awide,uniformfrequencyresponseandasmallactive At high frequencies the measurement of “point” field quantities is hampered by spatial averaging effects dueelement, although the latter is not as critical, 0.5-1 mm being to the finite sizeof the sensing element. Ideally, the receiver sufficient in most cases. Because ofthe potential for damage dimensions should be less than one wavelength, hut at 15 tothehydrophone,additionalfeaturesalsoareimportant MHzinwaterthisvalueis 0.1 mm. One approachfor [63], [64]: robustness, to withstand the intense fields and overcoming the size limitations of availzble hydrophones has possible cavitation effects; electrical shielding, to suppress been to performpulse-echobeamprofilemeasurements RF interference and provide insulation from the conductive using fine wire or spherical targets [57], [S]. Wire sizes propagation media sometimes used; and a large dynamic 1999 IEEE ULTRASONICS SYMPOSIUM - 1345 pulse fidelity, especially the trailing edge, is degraded by range. In [61] a high-performance hydrophone, termed a attenuation in the front plate as well as its two-way travel “focus”hydrophone,isdefinedformeasurements at the time (about 3.3 focuswheretherequirementsaremostdemanding.Itis ps for l 0 mm-thick steel), plus the generation stated that the focus hydrophone shall be equivalent to a of slower velocity shear waves in this plate. However, the to be relatively unaffected by single-filmpiezoelectricpolymerspot-poledmemhranetype measured p, seemed with film thickness not greater than 25 pm. While thicknesses of from6-18mm,andthedurabilityofthe membrane hydrophones appearto provide generally faithful hydrophone was good, with small pinholes being observed after 1000 pulses having peak amplitudes of 20-45 MPa. reproductionsoflithotripsypressurepulses,theyarefarfrom The effective diameterof the probe was calculated to be 2.1 ideal. In addition to the damage issue, an artifact has been seen in the hydrophone waveform due to reflections at the mm duetothefringeelectricalfield at thecapacitor boundary. hydrophonehousing[65].Thepresenceofthisartifact Electromagnetic hydrophone: Magnetic induction determineshowfarawayfromthelithotripsybeamaxis measurements can he made, especially if that structure is as a basisforconstructing a robust alsohasbeenused hydrophone. In [75]a probe is described in which a 5 mm highly reflective [66]. To overcome these problems, particularlywithregard to hydrophonedamage,several length (I) of 30 pm-thick copper wire was fused into the front face ofa 5 mm-diameterplastic rod.The front ofthe rod then alternatives the classical to spot-poled membrane hydrophone design have been explored, as discussed below. was placed in the field of a permanent magnet suchthat the While no single hydrophone design has yet emergedas the fused section of wire was oriented normally to the acoustic optimal choice, each of these variations has found use in and static magnetic(B=200 mT) fields. In this configuration the vibration of the wire due to the ultrasonic wave will lithotripsy field measurements. induceatimevaryingvoltage (e) at the wireterminals. Modijed membrane hydrophone: In one modified Assumingthatthewirethicknessisnegligibleandthe membraneapproach,unmetallizedPVDF film wasspotpoled and mounted inan enclosed chamber with an acoustic acousticandmagneticfieldsareuniformoverits5-mm window. The chamber was filled with either dielectric fluid length, p(t) is proportional to eB1. This electrical signal was [67] or low-resistivity electrolyte [68], [69]. Electrodes were amplified by a preamp located close to the magnet. Input located in the chamber away from the film, close enough to limiting ofthe preamp was necessary to clip the large signals collect the pressure-induced charge(via capacitive coupling arising from the lithotripter excitation pulse. in the former case), hut far enough away to minimize damage The high frequency response was limited by the -6 dBcorner from the shock waves. In a different approach, the goal has wirethickness,30pmgivingatheoretical been to produce an inexpensive, disposable membrane [70], frequency of - 5 MHz. Also, errors will be caused by the of uniform [71], [72]. In [72] a commercial shock gauge element was transverse resolutionof 5 mm and the assumption no fields over this length. However, a prototype showed mounted on a housing containing degassed petroleum as a signs of failure after exposureto 4000 pulses havinga p, of backing material for electrical isolation. Inanotherdesign the resistance of themetal electrodes and leads is monitored to 30 MPa. Another electromagnetic probe designed primarily indicate when the film should he replaced [71]. for quality control measurements employed a 12.7 mm steel Spot-poledceramic hydrophone:Inthisvariationon [76]. The ball was attached to a ballplacedatthefocus a spot-poled membrane, a lead titanate disk(15 or 30 MHz stainless steel rod containing the electromagnetic transducer resonance frequency) having a diameter of less than - I cm located between the polesofa permanent magnet. Although was spot-poled and brass-backed, and this assembly was connected to a coaxial cable [73]. Lead titanate was chosen theoutput of theprobedoesnotfollowthelithotripter pressurepulse, it has beenrelated to both p, andstone for its low radial mode coupling. Rise times <50 ns and effective diameters<0.5 mm have been achieved. A typical disintegration, and it was used to monitor the output of a lithotripter system over a 12-month period. lifetime of between 200 and 1000 shots at the focusofa 100 Fiber-opric hydrophone: The various deficiencies MPa (p,) lithotripter is reported, the major damage mechanismbeingpiningoftbeceramicduetocavitationjets. with hydrophones mentioned above (e.g., fragility in intense Capacitance hydrophone:To increase resistance to fields, susceptibility toRF interference, and, particularly for diagnostic fields, inadequate spatial resolution) have inspired hydrophone damage, a hydrophone bas been designed in which the incoming pressure wave modulates the air gap of the development of acoustic sensor designs basedon fibera parallel plate capacitor formed by a steel front plate and aoptic (FO) detection techniques. In the most successfulF 0 to form a rightcircular 2 mm diameter brass cylinder as the rear platelelectrode [74]. approaches,thefiber,cleaved cylinder, is aligned so that the endface isnormaltothe Assuming that the acoustic particle displacement is small compared to the air gap thickness d,, the measured pressure, direction of acoustic propagation, just as a piezoelectric needle hydrophone would be.In this configuration the fiber p(t), is proportional to d,e’iEoC,, where C, is the electrode behaves an extrinsic rather than intrinsic sensor, in that its is the capacitance, E, is the capacitor DC bias voltage, e’and basic function is simply to carry coherent light to the tip timederivativeofthemeasuredcapacitorvoltage. Measured 1346 - 1999 IEEE ULTRASONICS SYMPOSIUM where the transduction processis initiated. The tip has been acoustic displacement or, when a heterodyne technique is of which lead toa calculation of treated in several ways to create a reflected light signal that used, particle velocity, both the pressure. To correct for the tip diffraction noted above, can be related to the acoustic field. as well as other acoustic effects associated with the fiber, the 1) Bare fiber tip - In the simplest approach, light magnitudeofthedisplacementtransferfunctionwas from a laser diode is coupled to a multimode fiber with a measured experimentally using TDS both and interferometry bare endface [77]. To a good approximation, the light is [82]. Then, assuming minimum-phase behavior for the F0 reflectedaccordingtotheFresnelintensityreflection system so thatthephaseresponsecouldbeuniquely coefficient, R = [(nc-nw)/nc+nJ]*, wheren, and n, are the indices ofreflection ofthe fiber core and water, respectively.determined,themeasuredlithotripsypulsedatawere corrected via deconvolution. As discussed above in Sec. KC, pressure variations in the 3) Fabry-Perot interferometer- As an alternative to a changein density, which inturn alters acoustic wave cause the refractive indices, and thus the reflected light intensity. the optical complexity of two-beam interferometry, but still Over most of the pressure range associated with lithotripsy with improved sensitivity compared to the bare fiber design, aFabry-Perot(FP) interferometercan formed by attachingan pulses,thechangeinreflectedlightintensityhasan FP cavity to the end of the fiber[83], [S4],[ 8 5 ] , [86], [87]. approximatelylineardependenceonacousticpressure, When light is sent down the fiber, optical reflections occur at neglecting the acoustic scattering effects described below the interfaces between the fiber and cavity, and the cavity [77]. It should be noted that a change in n, will occur as andload(water).Theopticalreflectioncoefficientsare well, hut due to the much lower compressibility of the fiber determined either by the Fresnel formula for uncoated cavity material, this effect is negligible[77]. surfaces [83], [84], or by the type and thickness of metal The device in [77] had a bandwidth of 20 MHz, limited by the photodetector amplifier, an effective aperture coatings on these faces[ES], [87]. In general an FP cavity is a multiple-beam interference device, but its operation can be of 0.1 mm, and good immunity to RF interference. Due to a relatively low sensitivity, the minimum detectable pressure explainedbyconsideringonlythetwoinitialreflectionsfrom thecavitysurfaces.Theintensityofthereflectedlight was 0.5 MPa, value a acceptable for lithotripsy of these reflected beams, which measurements, but one that could be reduced with a higher depends on the interference in tum depends on the optical phase shift between them. light source power more or sensitive photodetector. Also, in Acoustically-induced changes in cavity thickness will vary comparison a with a PVDF membrane hydrophone measurement, it was noted that the negative pressure tail or this phase shift, and the acoustic pressure can be deduced from the optical, acoustic, and elastic properties of the cavity trough was shorter in the membrane-measured waveform. This has been attributed to the stronger water-fiber (silica) material, andthe undisturbed cavity thickness(L). Both polymer films and harder dielectric materials layer adhesion compared to that at the water-metal or waterhave been used for the cavity material, the former being polymer boundaries. This effect has been noted elsewhere, moresensitivedue to theirgreatercompressibility.The where p,% of -25 MPa [78] and -59 MPa [79] have been measured with an F 0 hydrophone, and it has served as the latter, however, canbe sputtered onto the endface[84], thus avoiding the degradation in frequency response that can arise [66]. The basis for adjusting membrane hydrophone results due to the adhesive layer that bondsthe polymer to the tip integrity of thetipcanbecheckedbymonitoring the quiescent reflected light intensity. The fiber tip has a high [85]. To avoid this adhesion problem, recently a polymer damage threshold, but should it be damaged by cavitation, film has been vacuum-evaporated onto thefiber tip [E7]. of multiple the fiher can be recut without affecting sensitivity; however,Also, toincreasesensitivity,anFPstack dielectric layers has been deposited onto the fiher [ES]. to maintain the minimum noise level, a clean, smooth fiber However, even without this last measure, sensitivities endface must he achieved. comparable to piezoelectric polymer hydrophones have been One problem reported in [77] is that diffraction at realized, and with significantly smaller sensitive areas. As the needle tip distorts the measured pulse, just as in the case of piezoelectric needle hydrophones described in Sec. ILA. with piezoelectric hydrophones, atrade-off is involved in the choice of L, in that sensitivity increases with increasingL, This problem is common to all F 0 hydrophones, and in[78] a simple extrapolation is shown to for correct overshoot in p,. but for a broadband response,L should be smaller than the A more rigorous deconvolution method is mentioned below.highest acoustic wavelength of interest. Also, both singleand multi-mode fibers have been used in these FP optical Also, inthefollowing F 0 hydrophonedescriptionsan improvement in sensitivity is achieved by treating the fiber sensors. The former gives better spatial resolution (e.g., 6 in [87]), and is less susceptibleto changes in sensitivity tip, but at the cost of design simplicity and replacement pm ease. due to fiber bending [ S ] , [87]. On the other hand, multi2) Two-beam interferometer - To increase mode F 0 hydrophones are easier to align with the laser measurement sensitivity, the fiber tip has been mirrored and before use [U]. Finally, as stated above, the tip diffraction incorporatedintothemeasuring arm of atwo-beam interferometer [EO], [SI]. The optical phase change caused problem needs further investigation in order to make the use of any type of F 0 hydrophone more practical. by the tip movement results in a signal proportional to the 1999 IEEE ULTRASONICS SYMPOSIUM - 1347 A . HIFU B. Measurement ofpulse energy There are no current standards for characterizing ofthe The energy impinging on the stone is the physical HIFU fields. Measurements typically have been made power, field quantity most closely associated with volume erosion ultrasonic W,, with an RFB, and the beam distribution in water around the focus. The beam plots have [a]This . quantity usually is calculated from hydrophone scans in the focal plane, and for a circularly symmetric beam been obtained with both hydrophones (for derived I,A) and the suspended ball radiometer (for I, directly) (see [3], p. withradialdimension r, theenergyEperpulseis, E=2nZ-'[jp2(r,t) dt rdr, where 2 is the acoustic impedance of207). The ball is more robust, but the ball calibration factor water. This quantity is not uniquely defined, however, until is a complicated functionof frequency, so its use is restricted the temporal and spatial integration limits are specified to narrow bandwidth fields. Therefore, errors can be large [SS]. In [61] the temporal integration time may be either over the whenmeasuringhighintensityfieldsinwhichnonlinear initial positive pressure spike (TJ, or over the entire pulse propagation effects lead to significant harmonic generation. (TT)(both definedby the first and last lO%-of-peak pressureAlso, acousticstreamingcanbeanimportantsourceof points). Also, in [6 l] the radial scan limit may be defined measurement error at high intensities. To address these measurement problems, and to either by the-6 dB point (E=E,), or by a specifieddistance R provide a single exposure quantity with relevance to thermal that corresponds to a particular stone dimension @=E,). A third scan limit has been described in which the integration lesion formation, a new intensity has been proposed [93]. Denoted I, it is the TA intensity spatially averaged over is stopped at the point where p, = 5 MPa [64]. In one study of these three spatially-defined pulse energies (using TTand the-6 dB beamarea,thelattermeasuredunderlinear R=5 mm), it was found that E a 5 MPa was highly correlated conditions. That is, ISAL= W.,/A,, where W., is the power with fragmentation of model stonesin vitro, whereas E, was within the contour defined by the half-maximum pressure, and A, istheareaenclosedbythat a poor indicator of stone destruction 1901. These and other -6 dB contour. results are summarized in [64], where it is emphasized that Measuring A, at low output as specified avoids the problems if lithotripters are to he compared based on pulse energy, associated with hydrophone instability and damage, and the then it mustbe established that the integration limits are the hydrophoneneednotbecalibrated.Inpractice, in situ same. intensities are calculated using linear derating[93], [94]. Using the theoretical jinc-squared radial intensity distribution at the focus of a source with circular aperture, the C. Optical techniques Acousto-optic methods also have been explored forspatial-peak pressure is I,, = 1.8IsAL= I .56.WJ(d~,)', where characterizing lithotripsy fields. These include a schlieren d, = (4A.6/n)o.s.When these quantities wereused in models of thermal lesioning threshold intensity and lesion size, the system,inwhicharubylaserpulse of 20 ns was was predictions agreed well with experimental results, itand synchronized tothe acoustic pulse, giving a spatial resolution of 30 p n in water [91]. Also, Michelson a type concludedthat I,,, wasausefulexposurequantityfor interferometer has been adapted to measure the pellicle (i.e., focused surgery in terms of both measurement ease and biophysical relevance. particle)velocity,fromwhichtheacousticpressureis Measurements of focal intensities at the highest calculated [92]. Movement of the acousticallythinbut levels used (several thousand W/cm2) have been performed a Doppler shift in the causes opticallyreflectivepellicle with spot-poled membrane hydrophones, either the frequency of thereflectedlight. This frequencychange results ina modulated light intensity, measurement of which disposable type 1951, [96], (as in [7l I), or with the pulse duration reduced dramatically (e.g., tens of ps or less) to allows the particle velocity can be calculated. The system minimize the riskof hydrophone damage, [97], [98]. In the bandwidth,limitedmainlybythephotodetectors,is 100 latter case, the intensity for pulse durations used clinically is MHz,andthevelocityrangeof1-100m/sconespondstothat All theshort-pulsemeasurements. obtainedbyscaling produced in lithotripsy. measurements shouldbe madein clean, degassed water(1-2 ppm 0,) to reducethepotentialforcavitation-generated V. THERAPEUTIC ULTRASOUND damage or error (a statement applicableto all high-intensity Clinical usesoftherapeutic ultrasound now encompass such measurement situations). A more qualitative but very effective means that has areas as hyperthermia, enhanced drug delivery for been used to determine 2-D and 3-D beam distributions in thrombolysis, fracture healing, phacoemulsification, waterforHIFUtransducersincorporatesacousto-optic physiotherapy, and high intensity focused ultrasound (HIFU) diffraction as in Sec. ILC[99]. Asstated there, this approach for surgery and hemostasis. Lithotripsy, covered above in Sec. IV, would be included as well,and the requirements for is inherently non-perturbing, has good spatial resolution, and provide rapid a means for observing beam hydrophones listed in Sec. 1V.A also apply when measuring can high-intensity surgicalor therapeutic fields. Some important characteristics. Onceregionsofhigh intensity are identified, they can be probed more critically using calibrated aspects of these measurements follow. 1348 - 1999 IEEE ULTRASONICS SYMPOSIUM piezo-ceramic hydrophones are adequate for recording the to the transducer being pressure, with values close extrapolated from radial plots made normal to the cylinder axis. The power can be derived from hydrophone scan data, is or via an RFB.In the latter case, a conical reflector has been usedtodirectthecylindricallydivergingbeamontoan absorbing RFB target. The potentiationof chemotherapy by pulsed ultrasoundhasbeendemonstratedusingunfocused,plane of a 2 MHz, 3.8 cm-diameter transducers.Inonestudy source [1051, a region of the field having a relatively smooth distribution was identified, and the pressure waveform was recordedoveracentral,transverseplaneusinga B. Physiotherapy 2 mm samplinginterval. Diagnosticpulsedefinitionsforintensities Physicaltherapistsadjustthelevel of exposure and physiotherapy definitions for beam nonuniformity were duringatreatmentusingaquantitydisplayedonthe calculated. This hybrid group of exposure quantities was equipment known as the effective intensity, defined as W, divided by the effective radiating area, or ERA. The ERA is then used to correlate exposure with biological response. the areaof the surface close to the transducer through which essentially all of the ultrasound power passes. The ERA is D. Low-frequency ultrasound surgery determineddirectly fromfieldmeasurements,specificallyvia In the 20-60 H z range, ultrasound finds use in ophthalmic, neurological, dental, and plastic surgery, and hydrophonescanning.ArecentIECstandardforthese also thrombolysis and angioplasty. Device operation devices [l011 provides a more reproducible measurement involves the vibration of a small wire method for the ERA, in that it is not based on a perc of entage or hollow needle, the maximum hydrophone output close to the transducer as resultingindestruction of tissueviamechanicalmeans, in previous methods[ 1021, and thereforeit is notas sensitive including cavitation. Measured acoustic quantities include wire or needle tip displacement, frequency, pressure, and to hydrophone sampling to differences in hydrophone or size 1998 IEC power.Measurementmeansarespecifiedina that might miss the point of highest pressure. In the new standard [106],and are discussed in [l071 and [108]. The approach,atseveralplanesa2-Darray of hydrophonemeasured data with step size As is sorted from lowest to power is derivedfromhydrophonemeasurements,using either a monopoleor dipole source model depending on the highest, and a running summation is computed. An area proportional to the productWAS' is then found, whereN is assumed depth of the vibrating tip in water or tissue. One the number of data points associated with75% of the total problem identifiedwiththis as tip procedure isthat displacement increases, cavitation activity causes the summation.TheERAisfoundfromanextrapolation of hue power.A these areas back to the applicator surface. This method has calculatedpowertounderestimatethe correction has been described in which the high frequency been found to give reproducible results in a study among components of the acoustic energy generated by cavitation three measurement laboratories [102]. Also regarding the implosionsaremeasuredwithahydrophonesensitiveat ERA, a non-scanning method has been proposed recently [103]. It involves RFB measurements of the power passing megahertz frequencies [107]. Future revisions of the IEC standard may incorporate such a procedure. throughasetofdifferent-sizedattenuatingapertures. Acceptableagreement withthescanning-summation method VI. IN VIVOMEASUREMENTS was found, and this method is suggested as a fast, relatively simple procedure for measuring the ERA in a manufacturing Piezoelectric needle hydrophones have been the traditional or clinical setting. means for in vivo pressure measurements; however, other aproaches are being tried. For example, in [l091 a sevenC. Ultrasound-enhanced drug delivery element linear array of PVDF elements was described that Ultrasound has been found to increase the rate of measures in vivoexposures intervaginally during an obstetric clot lysis when used conjunction in with various ultrasound examination. The OS-mm-diameter PVDF thrombolyticdrugs.Inonedesign,asmallcylindrical elements were spaced 1.S mm apart along a stainless steel piezoelectrictransducer is mounted in thedrug-delivery tube. For in vivo lithotripsy measurements, two catheter and driven with both long-pulse and CW 1 MHz modifications of thesingle-sheet,spot-poledmembrane ultrasound[104].Themechanisms of actionarenot design have been used. In one, previously metallized and completely understood, but both thermal and non-thermal spot-poled PVDF film was formed into a hemispherical shell contributions are likely, including stable cavitation. supportedbya soft, low-impedancebacking [IlO]. The Accordingly, exposure measurements have included both resultant bulb was mounted on the end of a stainless steel power and pressure. Because the signals are narrowband, hydrophones. Lastly,anelectromagnetic pressuresensorhasbeen developed for MRI-guided HIFU applications [loo]. The transducercomprises6tumsofO.lmmdiametercopperwire wound on a plastic core measuring 40x3.2 mm. A voltage induced in the coil by ultrasonically-mediated movement of the wire in theMM device's static magnetic field. For 750 kHz ultrasound the sensitivity was 1.g VMPa, and the noise pressure level was 1 kPa for a 4.7 T magnet. The sensor is saidtobeusefulformeasuringpressuretocalculate temperature rise, or inQC testing of the HIFU transducer. 1999 IEEE ULTRASONICS SYMPOSIUM - 1349 [4] M.Hodnett and B. Zeqiri, “A strategy far lhedevelopmentand tube, with electrical connection being made via a coaxial standardization of measurement methods for high poWCr/Cmitaling cable as in the needle hydrophone. In another lithotripsy ulWsonicfields:Reviewofhighpowerfieldmuvurementtechniques,”NPL hydrophonedesignformeasurementsinpigs,apiece of ReporlCIRA-(EXT)O15. Teddington, UK: 1997, ISSN 1361-5053. metallized, spot-poled film was stretched over a plastic ring [5]G.R.HarrisandP.A.Lewin,“Ultrasonicenposimehy,”Encvclooediaof Electrical and Electronics Engineering.New York John Wiley, 1999, vol. having an outsidediameter of 21.5 mm [ I l l ] . After 22, J.G. Webster,Ed.,pp. 634-646. connecting coaxial a cable,thisminiaturemembrane [6] A.C. Balrer, “Nonlinear effects in ultrasound propagation.” hydrophonewasthencoatedwithsiliconerubberbefore inMedicine.Bfistol,UK: InstiruteofPhysics Publishing, 1998,F.A. Duck, implantation to provide electrical insulation. More recently A.C. Baker, andH.C. Stanitt, Eds., pp. 23-38. afiber-optichydrophonewasusedformeasurementsin [7]G.R.Harris,”Pressurepulsedistonionbyhydrophonesduetodiminished low frcqumcy response,” IEEE Trans. UFFC, vol. 42, pp. 989-992, 1995. patientsundergoingclinicallithotripsytreatment [U]. In [SI G.R. Harris, “Arecurrent hydrophonelow frequency response standards addition to small size, other advantages were: no electrical acceptableformeasuringmechanical/cavifationindices?,”Ult~osonics,vol. contacts to patient; performance unaffected by conductive 34, pp. 649-654, 1996. body fluids; easily replaceable so cross-infection hazards [S] Slandord/oor Red-Time Display o/Thhermal and Meehonicd Acouslic Output Indices on Diagnostic Ultraround Equipment, Rev. I,Am. Inst. of minimized and alignment errors reduced by wide angular in Med., Laurel, M D Nat. Electr. Manu. Assoc., Rosslyn. VA response. Problems were experienced, as discussed in Sec. Ultrasound (NEMA Publ. UD 31, 1998. IV.A, but with further development these F 0 devices seem [IO] 1. Abbott, “Rationale andderivation of MI and TI . A review;’ to hold promise for invasivein vivo exposimetly. Oit~~~oundinMed&Biol.,vol.25,pp.431-441, 1999. Regarding noninvasive measurements, quantitative [I11 Acoufic outpur meusurement slondard /or diagnostic dtrosound equipment, Am. Inst. afUltrasound in Med., Laurel,MD; Nat. Electr. Manu. mapping of ultrasound fields in tissue phantoms has been Assoc., Rosslyn, VA (NEMA Publ. UD 2, Rev. Z), 1998. demonstrated via MR imaging [112]. Absolute [l21 Measurement and choroderimlion of ulrrasonlc fields using measurements of acousticdisplacementamplitudeswere hydropkonerinfhe/requencyrangeO.IMHrlo15MH~,IEC,Geneva,Publ. achieved, and the noise-equivalentpressure, calculated via a IEC61102, 1991. plane wave assumption at the 515 kHz frequency used, was [l31 S.P. Robinson, “A comparison ofthe frequency response ofmembrane and needle probe PVDF hydrophones,”Physics in Medical Ultrasound 11. 19 kPa. Advantages include the abilityto make noninvasive York, U K InStiNte ofPhysical Sciences in Medicine, 1988, D. Evans and measurementsinopaquemedia,unliketheacousto-optic K.Marlin, Eds.,pp.79-86. methods in Sec. KC. However, the B-field gradient used [l41 B. Fay, G. Ludwig, C. Lankjaer,and P.A. Lewin,”Frequencyresponse ofPVDF needle-type hydrophones.”Ultrasound in Med. & B i d , YOI 20, pp. wasabouttentimeshigherthanthatrecommendedfor 361-366, 1994. human imaging. [IS] G.R. Harris and P.M. Gammell, “Sensitivity meaSwements of piewelectricpolymerhydrophonesfrom0.2-2MHrusingabraadbandpulse VII. CONCLUSION technique,”J. Acaust. Soc.Am., vol. 105,pp. 725-731, 1999. [16]P.A.Lewin,R.Bautista,andV.Devaraju,“Voltagesensitivityrespanre This paper contains a reviewof the progress and problems of ultrasonic hydrophones in the frequency range 0.25-2.5 MHz,” U/t~~aundlnMed.&Bio/.,vol.25,pp.II3l-1137,1999. associated with ultrasound exposure measurements. A wide [l71 P.M. Gammell and G.R. Harris, ”Time delayspectramctry for array of topics was discussed, but coverage was by no means hydrophone calibrations below I MHz,” J Aeousl. Soc. Am. (ARLO - in press) 1999. complete. For example, the measurement oftransient stress waves induced purposefullyor not by medical laser radiation [l81 A.R.Selfridge andJ.P. Goetz, “Ellipsoidal hydrophonewith improved characteristics.” Pmc. 1999 IEEE Ultroson. Symp. was omitted. Also, non-invasive measurement of [l91 Reyuiremenlsfor the declorotion o/rhe acoustic oulput of medico1 temperature rise in tissue via MFU or ultrasound was not diagnostic ultromnic equipment, IEC, Geneva, Publ. IEC 61 157, 1992. discussed; nor were means to monitor cavitation activity. [201Aeousticoutputlobelingrtond~rd/~rdiagnosti~icltrosoundequipment: These latter two are not exposure measurements per se, hut Aslnndard/~rhowmnnuf~cturersshouldspec~~ocowricoutpurdoia,Am. Inst. ofUltmound in Med., Laurel, MD, 1998. they shouldbe mentioned when discussing means toassess [2I]T.ChristopherandE.L.Cantensen,“Fi~ileamplitudedistorlionandits the effectiveness and risk potentialof medical procedures. relationship to linear derating formulae for diagnostic ultrasound devices.” Aproperunderstanding of thecapabilities as well as Ultrasound in Med. & Bioi., vol. 22, pp. 1103-1 116, 1996. limitations of all these devices and methodsis essential for 1221 WorldFederationforUltrasoundinMedicineandBiology:Conclu~ionr recommendations on lhermal and non-thermal mechanisms for accurate ultrasound field characterization, and it is hoped and that biological eiTkcts of ulbasound. S.B. Bamett, Ed., Ullrasound in Ued. & the material presented here will contributeto that goal. B i d , vol. 24, suppl. I,p. S47, 1998. [23] E.L. Cantensen, D. Dalccki, S.M. Gracewski,and T. 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