ABSTRACT
A project has been completed to develop reference methods for the measurement of ultrasonic power with a validated measurement uncertainty of < 7% at power levels of 1 to 20 W over the frequency range 1 to 3 MHz of collimated beams. The project is the result of collaborative research between the Physikalisch-Technische Bundesanstalt, Germany (PTB, DE), the National Physical Laboratory, UK (NPL, UK) and the Netherlands Organisation for Applied Scientific Research, Prevention and Health (TNO-PG, NL). The work has been undertaken under the 4th Framework Programme of the European Community (EC). Primary standard designs of radiation force balances based on both absorbing and reflecting targets have been constructed. To avoid heating effects, the measurements should be done relatively quickly (10 to 20 s). The methods have been validated using ultrasound (US) transducers that demonstrated an adequate short and long-term stability; a method to detect cavitation based on monitoring the acoustic signals produced by bubble oscillation and collapse has been confirmed. It has been shown that only the detection of the subharmonic can be used in practice as cavitation detector. Different procedures for obtaining degassed water have been investigated. A method showing significant promise to be used in a clinical or manufacturer's environment involves the addition of sodium sulphite (Na2SO3). During the validation process, commercially available radiation force balances and ultrasonic physiotherapy devices have also been evaluated. Limitations of current measurement methods and practices, including power measurements made on transducers exhibiting a diverging beam, have been identified. It has been shown that a reflecting target is not appropriate to measure powers of transducers with a ka-value < 30. Based on beam shape and target distance, it has been shown also that proper power measurements using a 45 degrees convex-conical reflecting target can never be performed for transducers with a ka-value < 17.4.
Subject(s)
Ultrasonic Therapy/standards , Physical Therapy Modalities/instrumentation , Physical Therapy Modalities/standards , Quality Control , Reference Standards , Ultrasonic Therapy/instrumentation , UltrasonicsABSTRACT
PURPOSE: The authors, forming part of a multicenter project funded by the European Community, summarize the validation of a tissue-mimicking flow Doppler test object and of procedures for testing medical diagnostic Doppler equipment. The results of the project are expected to contribute to a future international IEC Standard concerning flow Doppler test objects (Draft IEC 61685 Standard) and for the European Medical Device Directive (MD 93/42/EEC). METHODS: Within this project a test protocol was developed that includes a set of different procedures, suitable for checking Spectral and Colour Doppler systems. The performance parameters for describing the image quality as well as the accuracy and the correct functioning of a system are in accordance with the definitions made in the Draft IEC 61685 Standard. RESULTS: A survey of the design and materials used for this Doppler test object will be presented with a special emphasis on the suitability of the procedures for routine measurement of performance parameters in hospitals. CONCLUSION: The test object satisfies the requirements of the Draft IEC 61685 Standard. The test procedures in combination with this test object can be used for checking different transducer models with nominal frequencies between 2.5-10.0 MHz.
Subject(s)
Ultrasonography, Doppler, Duplex/instrumentation , Ultrasonography, Doppler, Duplex/standards , Blood , Computer Simulation , Europe , European Union , Humans , Image Processing, Computer-Assisted , International Cooperation , Phantoms, Imaging , Quality Assurance, Health CareABSTRACT
Doppler test objects are used to characterise Doppler systems, both stand-alone systems and the Doppler part of so-called duplex scanners. The aim of the project partially presented here is the development and validation of an example of a Doppler test object fulfilling the requirements of the IEC 1685. The project has been carried out by nine partners of five European countries and has been funded by the European Commission. The flow Doppler test object is composed of: tissue mimicking material (TMM), blood mimicking fluid (BMF), tube (embedded in the TMM and carrying the BMF), tank flow system, including a pump and a flow meter. In the normative part of the IEC 1685, requirements are given for the values of acoustical parameters of TMM and BMF such as sound velocity, attenuation and backscattering. For BMF, requirements are given also for values of density and viscosity. In an informative (but not compulsory) annex, a description is given of a flow test object meeting these requirements as an example. 'example test object' developed during the project is composed of TMM based on agar and including SiC- and Al2O3-powders, BMF based on nylon particles suspended in water and glycerine, and a tube of c-flex, a silicon copolymer. Two tube sizes are used: 4.0 mm ID and 8.0 mm ID. During the project, very precise recipes have been developed for the composition and preparation of both TMM and BMF. Based on these recipes and a description of the construction in a design five flow test objects have been constructed in the laboratories of five participants. The test objects have been compared by measurements of the physical parameters and by Doppler measurements of the five test objects with the Doppler system. The measurements have been carried out by five observers. Inter-test object and inter-observer variabilities are determined, yielding information about usefulness of the parameters.
