Skip to main content
SpringerLink
Log in

Inspection and Testing of Diagnostic Ultrasound Devices

  • Chapter
  • First Online:
Inspection of Medical Devices

Part of the book series: Series in Biomedical Engineering ((BIOMENG))

  • 1105 Accesses

Abstract

This chapter provides an overview of the safety aspects of application of ultrasound in medicine. It starts with the short history of ultrasound methods and devices as well as basic principles of ultrasound imaging systems. The application of ultrasound in medicine greatly evolved and nowadays it can be divided into two main areas: imaging and therapy. In order to assure a safe and responsible application of ultrasound in medicine one should be aware of physical processes which can be produced in tissue by ultrasound such as temperature rise, cavitation and acoustic streaming. The importance of understanding how these processes can affect the human cell is self-explanatory. In order to better understand the guidelines for testing and quality control of ultrasonic devices it is necessary to give an overview of basic output parameters. Only the most important parameters from the point of safe use of ultrasound are described, e.g. acoustic pressure, acoustic power and intensity. In order to protect the public against inappropriate exposure when ultrasound is used for medical applications, international standards and national regulations are developed. Diagnostic ultrasound imaging is very often the basis for diagnostic decision; therefore it is also necessary to include such systems into a comprehensive quality assurance programme. Ultrasound systems used for therapy have larger intensities though there are additional safety requirements compared to diagnostic systems. The ultrasound intensity, effective radiation area and beam non-uniformity ratio and are parameters which should be monitored.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution

Subscribe and save

Springer+ Basic
$34.99 /Month
  • Get 10 units per month
  • Download Article/Chapter or eBook
  • 1 Unit = 1 Article or 1 Chapter
  • Cancel anytime
Subscribe now

Buy Now

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 79.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 99.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Similar content being viewed by others

References

  1. Manbachi A, Cobbold RSC (2011) Development and application of piezoelectric materials for ultrasound generation and detection. Ultrasound 19(4):187

    Article  Google Scholar 

  2. Kremkau FW (2006) Diagnostic ultrasound. Principles and instruments, Chap. 4, 7th edn. Saunders, Philadelphia, USA

    Google Scholar 

  3. Macovski A (1983) Medical imaging systems, Chap. 10. Prentice-Hall, Englewood Cliffs, NJ

    Google Scholar 

  4. IEC 60601 part 2–5, Medical electrical equipment: particular requirements for the safety of ultrasound physiotherapy equipment. International Electrotechnical Commission, Geneva

    Google Scholar 

  5. IEC 60601 part 2–37: Medical electrical equipment: particular requirements for the safety of ultrasound diagnostic and monitoring equipment, 2001 consolidated with amendment 1, 2004. International Electrotechnical Commission, Geneva

    Google Scholar 

  6. IEC 60601 part 2–62 (2013) Medical electrical equipment: particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment. International Electrotechnical Commission, Geneva

    Google Scholar 

  7. Perkins MA (1989) A versatile force balance for ultrasound power measurement. Phys Med Biol 34(11):1645

    Article  Google Scholar 

  8. Farmery MJ, Whittingham TA (1978) A portable radiation-force balance for use with diagnostic ultrasonic equipment. Ultrasound Med Biol 3(4):373–379

    Article  Google Scholar 

  9. Carson PL, Fischella PR, Oughton TV (1978) Ultrasonic power and intensities produced by diagnostic ultrasound equipment. Ultrasound Med Biol 3(4):341–350

    Article  Google Scholar 

  10. Farmery MJ, Whittingham TA (1978) A portable radiation-force balance for use with diagnostic ultrasonic equipment. Ultrasound Med Biol 3:373–379

    Article  Google Scholar 

  11. Duck FA (1989) Output data from European studies. Ultrasound Med Biol 15(Suppl 1):61–64

    Article  Google Scholar 

  12. Duck FA, Martin K (1991) Trends in diagnostic ultrasound exposure. Phys Med Biol 36(11):1423–1432

    Article  Google Scholar 

  13. Henderson J, Willson K, Jago JR, Whittingham TA (1995) A survey of the acoustic outputs of diagnostic ultrasound equipment in current clinical use. Ultrasound Med Biol 21(5):699–705

    Article  Google Scholar 

  14. Whittingham TA (2000) The acoustic output of diagnostic machines. In: ter Haar G, Duck FA (eds) The safe use of ultrasound in medicine diagnosis, 2nd edn. BMUS/BIR, London, UK

    Google Scholar 

  15. FDA (1997) Information for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers. Division of Reproductive, Abdominal, Ear, Nose, Throat and Radiological Devices: Office of Device Evaluation. US Department of Health and Human Services: Food and Drug Administration

    Google Scholar 

  16. AIUM/NEMA (1992) UD2: Acoustic output measurement standard for diagonstic equipement (Rockville, MD: American Institute of Ultrasound in Medicine)

    Google Scholar 

  17. Bigelow TA, Church CC, Sandstrom K, Abbott JG, Ziskin MC, Edmonds PD, Herman B, Thomenius KE, Teo TJ (2011) The thermal index: its strengths, weaknesses, and proposed improvements. J Ultrasound Med 30(5):714–734

    Google Scholar 

  18. Apfel RE, Holland CK (1991) Gauging the likelihood of cavitation from short-pulse, low-duty cycle diagnostic ultrasound. Ultrasound Med Biol 17(2):179–185

    Article  Google Scholar 

  19. Curch CC (2002) Spontaneous homogeneous nucleation, inertial cavitation and the safety of diagnostic ultrasound. Ultrasound Med Biol 28(10):1349–1364

    Article  Google Scholar 

  20. Duck FA, Starritt HC, ter Haar GR, Lunt MJ (1989) Surface heating of diagnostic ultrasound transducers. Br J Radiol 62:1005–1013

    Article  Google Scholar 

  21. BMUS (2010) Guidelines for the safe use of diagnostic ultrasound equipment. Ultrasound 18:52–59

    Article  Google Scholar 

  22. Calvert J, Duck F, Clift S, Azaime H (2007) Surface heating by transvaginal transducers. Ultrasound Obstet Gynecol 29:427–432

    Article  Google Scholar 

  23. Quality assurance in diagnostic radiology: a guide prepared following a workshop held in Neuherberg, Federal Republic of Germany, 20–24 October 1980, and organized jointly by Institute of Radiation Hygiene, Federal Health Office, Neuherberg, Federal Republic of Germany, Society for Radiation and Environmental Research, Neuherberg, Federal Republic of Germany and World Health Organization, Geneva, Switzerland, 1982

    Google Scholar 

  24. Hangiandreou NJ, Stekel SF, Tradup DJ, Gorny KR, King DM (2011) Four-year experience with a clinical ultrasound quality control program. Ultrasound Med Biol 37(8):1350

    Article  Google Scholar 

  25. American College of Radiology (ACR) (2011) ACR technical standard for diagnostic medical physics performance monitoring of real time ultrasound equipment. ACR, Reston, VA

    Google Scholar 

  26. American Institute of Ultrasound in Medicine (AIUM) (2008) Routine quality assurance for diagnostic ultrasound equipment. AIUM, Laurel, MD

    Google Scholar 

  27. Goodsitt MM, Carson PL, Witt S, Hykes DL, Kofler JM (1998) Real-time B-mode ultrasound quality control test procedures. Report of AAPM Ultrasound Task Group No. 1. Med Phys 25:1385–1406

    Article  Google Scholar 

  28. International Electrotechnical Commission, IEC 62736-1 (2011) Ultrasonics—quality control of diagnostic medical ultrasound systems

    Google Scholar 

  29. Institute of Physics and Engineering in Medicine (IPEM) (2010) Quality assurance of ultrasound imaging systems, Report No 102, IPEM, York

    Google Scholar 

  30. Kollmann C, Dekorte C, Dudley NJ, Gritzmann N, Martin K, Evans DH (2012) Guideline for technical quality assurance (TQA) of ultrasoud devices (B-Mode)—Version 1.0 (July 2012). EFSUMB Technical Quality Assurance Group. Ultraschall Med 33:544–549

    Google Scholar 

  31. Dudley N, Russell S, Ward B, Hoskins P (2014) The BMUS guidelines for regular quality assurance testing of ultrasound scanners. Ultrasound 22:6–7

    Article  Google Scholar 

  32. Samei E, Badano A, Chakraborty D, Compton K, Cornelius C, Corrigan K, Flynn MJ, Hemminger B, Hangiandreou N, Johnson J, Moxley-Stevens DM, Pavlicek W, Roehrig H, Rutz L, Shepard J, Uzenoff RA, Wang J, Willis CE (2005) Assessment of display performance for medical imaging systems: executive summary of AAPM TG18 report. Med Phys 32(4):1205–1225

    Article  Google Scholar 

  33. Shaw A, Hodnett M (2008) Calibration and measurement issues for therapeutic ultrasound. Ultrasonics 48:234–252

    Article  Google Scholar 

  34. Gutiérrez MI, Calás H, Ramos A, Vera A, Leija L (2012) Acoustic field modeling for physiotherapy ultrasound applicators by using approximated functions of measured non-uniform radiation distributions. Ultrasonics 52(6):767–777

    Google Scholar 

  35. IEC 61689 (2007) Ultrasonics—physiotherapy systems—field specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz

    Google Scholar 

  36. Hekkenberg RT, Oosterbaan WA, van Beekum WT (1986) Evaluation of ultrasound therapy devices. Physiotherapy 72:390–395

    Google Scholar 

  37. Pye SD, Milford C (1994) The performance of ultrasound physiotherapy machines in Lothian region, Scotland. Ultrasound Med Biol 20(4):347–359

    Article  Google Scholar 

  38. Pye SD (1996) Ultrasound therapy equipment—does it perform? Physiotherapy 82(1):39–44

    Article  Google Scholar 

  39. Duck F (2009) Acoustic dose and acoustic dose rate. Ultrasound Med Biol 35(10):1679–1685

    Article  Google Scholar 

  40. Miller D, Smith N (2012) Overview of therapeutic ultrasound applications and safety considerations. J Ultrasound Med 31(4):623–634

    Article  Google Scholar 

  41. Pye S, Hildersley K, Somer E, Munro V (1994) A simple calorimeter for monitoring the output power of ultrasound therapy machines. Physiotherapy 80(4):219–223

    Article  Google Scholar 

  42. Zeqiri B, Barrie J (2008) Evaluation of a novel solid-state method for determining the acoustic power generated by physiotherapy ultrasound transducers. Ultrasound Med Biol 34:1513–1527

    Article  Google Scholar 

  43. Zeqiri B, Gélat PN, Barrie J, Bickley CJ (2007) A novel pyroelectric method of determining ultrasonic output power: device concept, modelling and preliminary studies. IEEE Trans Ultrason Ferroelectr Freq Control 54(11):2318–2330

    Article  Google Scholar 

  44. Zeqiri B, Žauhar G, Hodnett M, Barrie J (2011) Progress in developing a thermal method for measuring the output power of medical ultrasound transducers that exploits the pyroelectric effect. Ultrasonics 51:420–424

    Article  Google Scholar 

  45. Zeqiri B, Žauhar G, Rajagopal S, Pounder A (2012) Systematic evaluation of a secondary method for measuring diagnostic-level medical ultrasound transducer output power based on a large-area pyroelectric sensor. Metrologia 49(3):368–381

    Article  Google Scholar 

  46. Butterworth I, Barrie J, Zeqiri B, Žauhar G, Parisot B (2012) Exploiting thermochromic materials for the rapid quality assurance of physiotherapy ultrasound treatment heads. Ultrasound Med Biol 38(5):767–776

    Article  Google Scholar 

  47. Žauhar G, Radojčić ĐS, Dobravac D, Jurković S (2015) Quantitative testing of physiotherapy ultrasound beam patterns within a clinical environment using a thermochromic tile. Ultrasonics 58:6–10

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Medical Faculty and Department of Physics, University of Rijeka, Rijeka, Croatia

    Gordana Žauhar

  2. Department of Medical Physics, Clinical Hospital Centre Rijeka, Rijeka, Croatia

    Ana Diklić

  3. Department of Medical Physics, Clinical Hospital Centre Rijeka and Medical Faculty University of Rijeka, Rijeka, Croatia

    Slaven Jurković

Authors
  1. Gordana Žauhar
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Ana Diklić
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Slaven Jurković
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Gordana Žauhar .

Editor information

Editors and Affiliations

  1. Verlab Ltd Sarajevo, Medical Devices Verification Laboratory, Sarajevo, Bosnia and Herzegovina

    Almir Badnjević

  2. Faculty of Electrical Engineering and Computing Zagreb, University of Zagreb, Zagreb, Croatia

    Mario Cifrek

  3. Faculty of Electrical Engineering and Computing Zagreb, University of Zagreb, Zagreb, Croatia

    Ratko Magjarević

  4. Institute of Metrology of Bosnia and Herzegovina, Sarajevo, Bosnia and Herzegovina

    Zijad Džemić

Rights and permissions

Reprints and permissions

Copyright information

© 2018 Springer Nature Singapore Pte Ltd.

About this chapter

Cite this chapter

Žauhar, G., Diklić, A., Jurković, S. (2018). Inspection and Testing of Diagnostic Ultrasound Devices. In: Badnjević, A., Cifrek, M., Magjarević, R., Džemić, Z. (eds) Inspection of Medical Devices . Series in Biomedical Engineering. Springer, Singapore. https://doi.org/10.1007/978-981-10-6650-4_6

Download citation

  • DOI: https://doi.org/10.1007/978-981-10-6650-4_6

  • Published:

  • Publisher Name: Springer, Singapore

  • Print ISBN: 978-981-10-6649-8

  • Online ISBN: 978-981-10-6650-4

  • eBook Packages: EngineeringEngineering (R0)

Publish with us

Policies and ethics

Search

Navigation