Skip to main content
Top

2018 | OriginalPaper | Chapter

Inspection and Testing of Noninvasive Blood Pressure Measuring Devices

Author : Igor Lacković

Published in: Inspection of Medical Devices

Publisher: Springer Singapore

Activate our intelligent search to find suitable subject content or patents.

search-config
loading …

Abstract

The main purpose of the present chapter is to provide an overview of noninvasive blood pressure measuring devices and their inspection and testing. The chapter first introduces systematic classification of methods for blood pressure measurement. Moreover strengths and weaknesses of each method are discussed. Devices for noninvasive blood pressure measurement are described. Several international standards for evaluating the accuracy of blood pressure monitors (AAMI/ANSI SP10, BHS, DIN, IEC, etc.) are compared. After that a section on the inspection and testing of noninvasive blood pressure measuring devices as recommended by the International Organization of Legal Metrology (OIML) is presented. At the end of this chapter a short summary is given emphasizing the importance of accuracy testing of noninvasive blood pressure measuring devices.

Dont have a licence yet? Then find out more about our products and how to get one now:

Springer Professional "Wirtschaft+Technik"

Online-Abonnement

Mit Springer Professional "Wirtschaft+Technik" erhalten Sie Zugriff auf:

  • über 102.000 Bücher
  • über 537 Zeitschriften

aus folgenden Fachgebieten:

  • Automobil + Motoren
  • Bauwesen + Immobilien
  • Business IT + Informatik
  • Elektrotechnik + Elektronik
  • Energie + Nachhaltigkeit
  • Finance + Banking
  • Management + Führung
  • Marketing + Vertrieb
  • Maschinenbau + Werkstoffe
  • Versicherung + Risiko

Jetzt Wissensvorsprung sichern!

Springer Professional "Technik"

Online-Abonnement

Mit Springer Professional "Technik" erhalten Sie Zugriff auf:

  • über 67.000 Bücher
  • über 390 Zeitschriften

aus folgenden Fachgebieten:

  • Automobil + Motoren
  • Bauwesen + Immobilien
  • Business IT + Informatik
  • Elektrotechnik + Elektronik
  • Energie + Nachhaltigkeit
  • Maschinenbau + Werkstoffe




 

Jetzt Wissensvorsprung sichern!

Literature
1.
go back to reference Levick JR (2010) An introduction to cardiovascular physiology, 5th edn. Hodder Arnold, London Levick JR (2010) An introduction to cardiovascular physiology, 5th edn. Hodder Arnold, London
2.
go back to reference Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo Jr. JL, Jones DW, Materson BJ, Oparil S, Wright Jr. JT, Roccella EJ et al (2003) Seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension. Joint National Committee On Prevention 42(6):1206–1252. doi:10.1161/01.HYP.0000107251.49515.c2 Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo Jr. JL, Jones DW, Materson BJ, Oparil S, Wright Jr. JT, Roccella EJ et al (2003) Seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension. Joint National Committee On Prevention 42(6):1206–1252. doi:10.​1161/​01.​HYP.​0000107251.​49515.​c2
4.
go back to reference Pickering TG, Hall JE, Appel LJ, Falkner BE, Graves J, Hill MN, Jones DW, Kurtz T, Sheps SG, Roccella EJ (2005) Recommendations for blood pressure measurement in humans and experimental animals: part 1: blood pressure measurement in humans: a statement for professionals from the subcommittee of professional and public education of the American heart association council on high blood pressure research. Circulation 111(5):697–716CrossRef Pickering TG, Hall JE, Appel LJ, Falkner BE, Graves J, Hill MN, Jones DW, Kurtz T, Sheps SG, Roccella EJ (2005) Recommendations for blood pressure measurement in humans and experimental animals: part 1: blood pressure measurement in humans: a statement for professionals from the subcommittee of professional and public education of the American heart association council on high blood pressure research. Circulation 111(5):697–716CrossRef
5.
go back to reference Geddes LA (1991) Handbook of blood pressure measurement. Humana Press, CliftonCrossRef Geddes LA (1991) Handbook of blood pressure measurement. Humana Press, CliftonCrossRef
6.
go back to reference Ng KG, Small CF (1994) Survey of automated noninvasive blood pressure monitors. J Clin Eng 19(6):452–475CrossRef Ng KG, Small CF (1994) Survey of automated noninvasive blood pressure monitors. J Clin Eng 19(6):452–475CrossRef
7.
go back to reference Drzewiecki GM, Melbin J, Noordergraaf A (1989) The Korotkoff sound. Ann Biomed Eng 17(4):325–359CrossRef Drzewiecki GM, Melbin J, Noordergraaf A (1989) The Korotkoff sound. Ann Biomed Eng 17(4):325–359CrossRef
8.
go back to reference London SB, London RE (1967) Comparison of indirect pressure measurement (Korotkoff) with simultaneous direct brachial artery pressure distal to the cuff. Adv Inter Med 13:127–142 London SB, London RE (1967) Comparison of indirect pressure measurement (Korotkoff) with simultaneous direct brachial artery pressure distal to the cuff. Adv Inter Med 13:127–142
9.
go back to reference Breit SN, O’Rourke MF (1974) Comparison of direct and indirect arterial pressure measurements in hospitalized patients. Aust N Z J Med 4(5):485–491CrossRef Breit SN, O’Rourke MF (1974) Comparison of direct and indirect arterial pressure measurements in hospitalized patients. Aust N Z J Med 4(5):485–491CrossRef
10.
go back to reference Geddes LA, Voelz M, Combs C, Reiner D, Babbs CF (1982) Characterization of the oscillometric method for measuring indirect blood pressure. Ann Biomed Eng 10(6):271–280CrossRef Geddes LA, Voelz M, Combs C, Reiner D, Babbs CF (1982) Characterization of the oscillometric method for measuring indirect blood pressure. Ann Biomed Eng 10(6):271–280CrossRef
11.
go back to reference Drzewiecki G, Hood R, Apple H (1994) Theory of the oscillometric maximum and the systolic and diastolic detection ratios. Ann Biomed Eng 22(1):88–96CrossRef Drzewiecki G, Hood R, Apple H (1994) Theory of the oscillometric maximum and the systolic and diastolic detection ratios. Ann Biomed Eng 22(1):88–96CrossRef
12.
go back to reference Geddes LA, Voelz M, James S, Reiner D (1981) Pulse arrival time as a method of obtaining systolic and diastolic blood pressure indirectly. Med Biol Eng Comput 19(5):671–672CrossRef Geddes LA, Voelz M, James S, Reiner D (1981) Pulse arrival time as a method of obtaining systolic and diastolic blood pressure indirectly. Med Biol Eng Comput 19(5):671–672CrossRef
13.
go back to reference Yamakshi K, Kamiya A, Shimazu H, Ito H, Togawa T (1983) Noninvasive automatic monitoring of instantaneous arterial blood pressure using the vascular unloading technique. Med Biol Eng Comput 21(5):557–565CrossRef Yamakshi K, Kamiya A, Shimazu H, Ito H, Togawa T (1983) Noninvasive automatic monitoring of instantaneous arterial blood pressure using the vascular unloading technique. Med Biol Eng Comput 21(5):557–565CrossRef
14.
go back to reference Sato T, Nishinaga M, Kawamoto A, Ozawa T, Takatsuji H (1993) Accuracy of a continuous blood pressure monitor based on arterial tonometry. Hypertension 21(6):866–874CrossRef Sato T, Nishinaga M, Kawamoto A, Ozawa T, Takatsuji H (1993) Accuracy of a continuous blood pressure monitor based on arterial tonometry. Hypertension 21(6):866–874CrossRef
16.
go back to reference Mion D, Pierin AM (1998) How accurate are sphygmomanometers? J Hum Hypertens 12:245–248CrossRef Mion D, Pierin AM (1998) How accurate are sphygmomanometers? J Hum Hypertens 12:245–248CrossRef
17.
go back to reference Markandu ND, Whitcher F, Arnold A, Carney C (2000) The mercury sphygmomanometer should be abandoned before it is proscribed. J Hum Hypertens 14:31–36CrossRef Markandu ND, Whitcher F, Arnold A, Carney C (2000) The mercury sphygmomanometer should be abandoned before it is proscribed. J Hum Hypertens 14:31–36CrossRef
18.
go back to reference Yarows SA, Qian K (2001) Accuracy of aneroid sphygmomanometers in clinical usage: University of Michigan experience. Blood Press Monit 6:101–106CrossRef Yarows SA, Qian K (2001) Accuracy of aneroid sphygmomanometers in clinical usage: University of Michigan experience. Blood Press Monit 6:101–106CrossRef
19.
go back to reference Canzanello VJ, Jensen PL, Schwartz GL (2001) Are aneroid sphygmomanometers accurate in hospital and clinic settings? Arch Intern Med 161:729–731CrossRef Canzanello VJ, Jensen PL, Schwartz GL (2001) Are aneroid sphygmomanometers accurate in hospital and clinic settings? Arch Intern Med 161:729–731CrossRef
20.
go back to reference Coleman AJ, Steel SD, Ashworth M, Vowler SL, Shennan A (2005) Accuracy of the pressure scale of sphygmomanometers in clinical use within primary care. Blood Press Monit 10(04):181–188CrossRef Coleman AJ, Steel SD, Ashworth M, Vowler SL, Shennan A (2005) Accuracy of the pressure scale of sphygmomanometers in clinical use within primary care. Blood Press Monit 10(04):181–188CrossRef
21.
go back to reference Association for the Advancement of Medical Instrumentation (1987) American National Standard. Electronic or automated sphygmomanometers ANSI/AAMI SP10-1987. 3330 Washington Boulevard, Suite 400, Arlington, VA 22201-4598, USA: AAMI Association for the Advancement of Medical Instrumentation (1987) American National Standard. Electronic or automated sphygmomanometers ANSI/AAMI SP10-1987. 3330 Washington Boulevard, Suite 400, Arlington, VA 22201-4598, USA: AAMI
22.
go back to reference Association for the Advancement of Medical Instrumentation (1993) American National Standard. Electronic or automated sphygmomanometers ANSI/AAMI SP10-1992. 3330 Washington Boulevard, Suite 400, Arlington, VA 22201-4598, USA: AAMI Association for the Advancement of Medical Instrumentation (1993) American National Standard. Electronic or automated sphygmomanometers ANSI/AAMI SP10-1992. 3330 Washington Boulevard, Suite 400, Arlington, VA 22201-4598, USA: AAMI
23.
go back to reference Association for the Advancement of Medical Instrumentation (1996) American National Standard. Electronic or automated sphygmomanometers ANSI/AAMI SP10-1992/A1. 3330 Washington Boulevard, Suite 400, Arlington, VA 22201-4598, USA: AAMI Association for the Advancement of Medical Instrumentation (1996) American National Standard. Electronic or automated sphygmomanometers ANSI/AAMI SP10-1992/A1. 3330 Washington Boulevard, Suite 400, Arlington, VA 22201-4598, USA: AAMI
24.
go back to reference Association for the Advancement of Medical Instrumentation (2003) American National Standard. Manual, electronic or automated sphygmomanometers ANSI/AAMI SP10-2002. 3330 Washington Boulevard, Suite 400, Arlington, VA 22201-4598, USA: AAMI Association for the Advancement of Medical Instrumentation (2003) American National Standard. Manual, electronic or automated sphygmomanometers ANSI/AAMI SP10-2002. 3330 Washington Boulevard, Suite 400, Arlington, VA 22201-4598, USA: AAMI
25.
go back to reference Association for the Advancement of Medical Instrumentation (2003) American National Standard. Manual, electronic or automated sphygmomanometers ANSI/AAMI SP10-2002/A1. 3330 Washington Boulevard, Suite 400, Arlington, VA 22201-4598, USA: AAMI Association for the Advancement of Medical Instrumentation (2003) American National Standard. Manual, electronic or automated sphygmomanometers ANSI/AAMI SP10-2002/A1. 3330 Washington Boulevard, Suite 400, Arlington, VA 22201-4598, USA: AAMI
26.
go back to reference Association for the Advancement of Medical Instrumentation (2013) American National Standard. ANSI/AAMI/ISO 81060-2:2013 Non-invasive sphygmomanometers—part 2: clinical investigation of automated measurement type. 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633, USA: AAMI Association for the Advancement of Medical Instrumentation (2013) American National Standard. ANSI/AAMI/ISO 81060-2:2013 Non-invasive sphygmomanometers—part 2: clinical investigation of automated measurement type. 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633, USA: AAMI
27.
go back to reference O’Brien E, Petrie J, Littler W, de Swiet M, Padfield PL, O’Malley K, Jamieson M, Altman D, Bland M, Atkins N (1990) The British Hypertension Society Protocol for the evaluation of automated and semi-automated blood pressure measuring devices with special reference to ambulatory systems. J Hypertens 8:607–619CrossRef O’Brien E, Petrie J, Littler W, de Swiet M, Padfield PL, O’Malley K, Jamieson M, Altman D, Bland M, Atkins N (1990) The British Hypertension Society Protocol for the evaluation of automated and semi-automated blood pressure measuring devices with special reference to ambulatory systems. J Hypertens 8:607–619CrossRef
28.
go back to reference O’Brien E, Petrie J, Littler W, De Swiet M, Padfield P, O’Malley K, Jamieson MJ, Altman D, Bland M, Atkins N (1991) The British Hypertension Society protocol for the evaluation of automated and semi-automated blood pressure measuring devices with special reference to ambulatory systems. J Ambul Monit 4:207–228 O’Brien E, Petrie J, Littler W, De Swiet M, Padfield P, O’Malley K, Jamieson MJ, Altman D, Bland M, Atkins N (1991) The British Hypertension Society protocol for the evaluation of automated and semi-automated blood pressure measuring devices with special reference to ambulatory systems. J Ambul Monit 4:207–228
29.
go back to reference O’Brien E, Petrie J, Littler W, de Swiet M, Padfield PL, O’Malley K, Jamieson M, Altman D, Bland M, Atkins N (1991) The British Hypertension Society Protocol for the evaluation of automated and semi-automated blood pressure measuring devices with special reference to ambulatory systems. In: O’Brien E, O’Malley K (eds) Blood pressure measurement. Birkenhager WH, Reid JL (eds) Handbook of hypertension. Elsevier, Amsterdam, pp 430–451 O’Brien E, Petrie J, Littler W, de Swiet M, Padfield PL, O’Malley K, Jamieson M, Altman D, Bland M, Atkins N (1991) The British Hypertension Society Protocol for the evaluation of automated and semi-automated blood pressure measuring devices with special reference to ambulatory systems. In: O’Brien E, O’Malley K (eds) Blood pressure measurement. Birkenhager WH, Reid JL (eds) Handbook of hypertension. Elsevier, Amsterdam, pp 430–451
30.
go back to reference O’Brien E, Petrie J, Littler WA, de Swiet M, Padfield PL, Altman D, Bland M, Coats A, Atkins N (1993) The British Hypertension Society Protocol for the evaluation of blood pressure measuring devices. J Hypertens 11(suppl 2):S43–S63 O’Brien E, Petrie J, Littler WA, de Swiet M, Padfield PL, Altman D, Bland M, Coats A, Atkins N (1993) The British Hypertension Society Protocol for the evaluation of blood pressure measuring devices. J Hypertens 11(suppl 2):S43–S63
31.
go back to reference O’Brien E, Petrie J, Littler WA, de Swiet M, Padfield PL, Altman D, Bland M, Coats A, Atkins N (1993) Short report. An outline of the British Hypertension Society Protocol for the evaluation of blood pressure measuring devices. J Hypertens 11:677–679 O’Brien E, Petrie J, Littler WA, de Swiet M, Padfield PL, Altman D, Bland M, Coats A, Atkins N (1993) Short report. An outline of the British Hypertension Society Protocol for the evaluation of blood pressure measuring devices. J Hypertens 11:677–679
32.
go back to reference O’Brien E, Atkins N, Stergiou G, Karpettas N, Parati G, Asmar R, Imai Y, Wang J, Mengden T, Shennan A; on behalf of the Working Group on Blood Pressure Monitoring of the European Society of Hypertension (2010) European Society of Hypertension International Protocol revision 2010 for the validation of blood pressure measuring devices in adults. Blood Press Monit 15:23–38 O’Brien E, Atkins N, Stergiou G, Karpettas N, Parati G, Asmar R, Imai Y, Wang J, Mengden T, Shennan A; on behalf of the Working Group on Blood Pressure Monitoring of the European Society of Hypertension (2010) European Society of Hypertension International Protocol revision 2010 for the validation of blood pressure measuring devices in adults. Blood Press Monit 15:23–38
33.
go back to reference O’Brien E, Pickering T, Asmar R, Myers M, Parati G, Staessen J, Mengden T, Imai Y, Waeber B (2002) Palatini P with the statistical assistance of Atkins N and Gerin W on behalf of the Working Group on Blood Pressure Monitoring of the European Society of Hypertension. International protocol for validation of blood pressure measuring devices in adults. Blood Press Monit 7:3–17CrossRef O’Brien E, Pickering T, Asmar R, Myers M, Parati G, Staessen J, Mengden T, Imai Y, Waeber B (2002) Palatini P with the statistical assistance of Atkins N and Gerin W on behalf of the Working Group on Blood Pressure Monitoring of the European Society of Hypertension. International protocol for validation of blood pressure measuring devices in adults. Blood Press Monit 7:3–17CrossRef
34.
go back to reference DIN 58130 Nichtinvasive Blutdruckmeßgeräte - Klinische Prüfung (1995) DIN 58130 Nichtinvasive Blutdruckmeßgeräte - Klinische Prüfung (1995)
35.
go back to reference European Standard EN 1060-1:1996. Specification for Non-invasive sphygmomanometers. Part I. General requirements. 1995. European Commission for Standardisation. Rue de Stassart 36, B-1050 Brussels European Standard EN 1060-1:1996. Specification for Non-invasive sphygmomanometers. Part I. General requirements. 1995. European Commission for Standardisation. Rue de Stassart 36, B-1050 Brussels
36.
go back to reference European Standard EN 1060-2:1996. Specification for Non-invasive sphygmomanometers. Part 2. Supplementary requirements for mechanical sphygmomanometers. 1995. European Commission for Standardisation. Rue de Stassart 36, B-1050 Brussels European Standard EN 1060-2:1996. Specification for Non-invasive sphygmomanometers. Part 2. Supplementary requirements for mechanical sphygmomanometers. 1995. European Commission for Standardisation. Rue de Stassart 36, B-1050 Brussels
37.
go back to reference European Standard EN 1060-3: 1997. Non-invasive sphygmomanometers. Part 3. Supplementary requirements for electro-mechanical blood pressure measuring systems. European Committee for Standardization. Rue de Stassart 36, B-1050, Brussels European Standard EN 1060-3: 1997. Non-invasive sphygmomanometers. Part 3. Supplementary requirements for electro-mechanical blood pressure measuring systems. European Committee for Standardization. Rue de Stassart 36, B-1050, Brussels
41.
go back to reference Ng KG, Small CF (1992) Review of methods & simulators for evaluation of noninvasive blood pressure monitors. J Clin Eng 17(6):469–479CrossRef Ng KG, Small CF (1992) Review of methods & simulators for evaluation of noninvasive blood pressure monitors. J Clin Eng 17(6):469–479CrossRef
42.
go back to reference Yong P, Geddes LA (1990) A surrogate arm for evaluating the accuracy of instruments for indirect measurement of blood pressure. Biomed Instrum Technol 24(2):130–135 Yong P, Geddes LA (1990) A surrogate arm for evaluating the accuracy of instruments for indirect measurement of blood pressure. Biomed Instrum Technol 24(2):130–135
43.
go back to reference Amoore J, Vacher E, Murray I (2006) Can a simulator that regenerates physiological waveforms evaluate oscillometric non-invasive blood pressure devices? Blood Press Monit 11:63–67CrossRef Amoore J, Vacher E, Murray I (2006) Can a simulator that regenerates physiological waveforms evaluate oscillometric non-invasive blood pressure devices? Blood Press Monit 11:63–67CrossRef
Metadata
Title
Inspection and Testing of Noninvasive Blood Pressure Measuring Devices
Author
Igor Lacković
Copyright Year
2018
Publisher
Springer Singapore
DOI
https://doi.org/10.1007/978-981-10-6650-4_5