VERIFICATION OF CLINICAL ACCURACY OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS: IS IT APPROPRIATE TO USE BLOOD PRESSURE SIMULATORS?
Autoři:
Jan Havlik; Vratislav Fabián
Působiště autorů:
Faculty of Electrical Engineering, Czech Technical University in Prague, Prague, Czech Republic
Vyšlo v časopise:
Lékař a technika - Clinician and Technology No. 1, 2020, 50, 5-11
Kategorie:
Original research
doi:
https://doi.org/10.14311/CTJ.2020.1.01
Souhrn
Cardiovascular diseases are the most common cause of death in developed countries. Blood measurement is an integral part of the diagnosis of these diseases. With the development of oscillometric blood pressure monitors, the question of regular monitoring of their clinical accuracy (overall error) has arisen. This paper deals with the overall accuracy of two commercial tonometers (Hartmann Digital HG 160 comfort and HuBDIC HBP–1520), using two calibrated blood pressure simulators (Fluke BP Pump 2 and Fluke ProSim). Using the Wilcoxon rank-sum test, significant differences between the simulators have been proved for all measurements—both for SBP and DBP measurements and both for Hartmann Digital HG 160 and HuBDIC HBP–1520 tonometers (p < 0.001). Therefore, without the precise knowledge of the relationship between the blood pressure monitor and the simulator used, it is not appropriate to use simulators to determine the overall error. On the other hand, the tested devices had a very good repeatability of the measurements at all presets, with both simulators. From this point of view, it is suitable to use simulators to determine the stability of measurement by a given tonometer rather than its clinical accuracy.
Klíčová slova:
Blood pressure – automated non-invasive sphygnomanometers accuracy – blood pressure simulators
Zdroje
- van Popele NM, Bos WJ, de Beer NA, van der Kuip, Deirdre AM, Hofman A, Grobbee DE, et al. Arterial Stiffness as Underlying Mechanism of Disagreement Between an Oscil-lometric Blood Pressure Monitor and a Sphygmomanometer. Hypertension 2000 Oct 1;36(4):484–8. DOI: 10.1161/01.HYP.36.4.484
- Wolf-Maier K, Cooper RS, Banegas JR, Giampaoli S, Hense HW, Joffres M, et al. Hypertension Prevalence and Blood Pressure Levels in 6 European Countries, Canada, and the United States. J Am Med Assoc 2003;289(18):2363–9. DOI: 10.1001/jama.289.18.2363
- Ferrucci L, Giallauria F, Guralnik JM. Epidemiology of Aging. Radiol Clin North Am 2008;46(4):643–52. DOI: 10.1016/j.rcl.2008.07.005
- World Health Organization. A global brief on hypertension: silent killer, global public health crisis: World Health Day 2013. 2013.
- Electronic or automated sphygmomanometers. American Na-tional Standard ANSI/AAMI SP10 1987.
- O'Brien E, Petrie J, Littler W, de Swiet M, Padfield PL, O'Malley K, et al. The British Hypertension Society protocol for the evalu-ation of automated and semi-automated blood pressure mea-suring devices with special reference to ambulatory systems. J Hypertens 1990 Jul;8(7):607–19. DOI:
- 10.1097/00004872-199007000-00004
- O'Brien E, Petrie J, Littler W, de Swiet M, Padfield PL, Altman D, et al. The British Hypertension Society protocol for the evalu-ation of blood pressure measuring device. J Hypertens 1993; 11:S43–62.
- O'Brien E, Atkins N, Stergiou G, Karpettas N, Parati G, Asmar R, et al. European Society of Hypertension International Protocol revision 2010 for the validation of blood pressure measuring devices in adults. Blood pressure monitoring 2010 Feb;15(1):23–38. DOI: 10.1097/MBP.0b013e3283360e98
- Stergiou GS, Alpert B, Mieke S, Asmar R, Atkins N, Eckert S, et al. A Universal Standard for the Validation of Blood Pressure Measuring Devices: Association for the Advancement of Medi-cal Instrumentation/European Society of Hypertension/Inter-national Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement. Hypertension 2018 Jan 31;71(3):368–74. DOI: 10.1161/HYPERTENSIONAHA.117.10237
- European Commission: Scientific Committee on Emerging and Newly Identified Health Risks. Mercury Sphygmomanometers in Healthcare and the Feasibility of Alternatives. [cited 19. 2. 2020]. Available at: https://ec.europa.eu/health/scientific_committees/ opinions_layman/sphygmomanometers/documents/sphygmomanometers_in_healthcare.pdf
- International Organization for Standardization. IEC 80601–2–30:2018 Medical electrical equipment – Part 2–30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers. 2018.
- International Organization for Standardization. ISO 81060–2:2018 Non-invasive sphygmomanometers – Part 2: Clinical investigation of intermittent automated measurement type. 2018.
- International Organization for Standardization. ISO 81060–1:2007 Non-invasive sphygmomanometers – Part 1: Require-ments and test methods for non-automated measurement type. 2007.
- European Committee for Standardization. EN 1060–3:1997+ A2:2009 Non-invasive sphygmomanometers – Part 3: Supple-mentary requirements for electro-mechanical blood pressure measuring systems. 2010.
- Non-invasive sphygmomanometers – Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers. European Standard EN 1060–4 2004.
- Rehadat. Hartmann Digital HG 160 comfort. [cited 10. 3. 2017]. Available at: http://www.rehadat-gkv.de/produkt/index.html?pg nr=21&aonr=28&produktId=21.28.01.2018&page=1&size=50
- HuBDIC Co. Ltd. Automatic Blood Pressure Monitor HBP–1520. [cited 9. 4. 2017]. Available at: http://ehubdic.cafe24.com/ product/detail.html?product_no=40&cate_no=25&display_group=1#prdDetail
- Czech Metrology Institute. Metrology regulation MP 017: Devices for blood pressure measurement, verification procedure [in Czech]. [cited 19. 2. 2020]. Available at: https://www.cmi.cz/ sites/all/files/public/download/MP%20017_verze_duben%202017.pdf
- European Committee for Standardization. EN 1060–3:1997 Non-invasive sphygmomanometers – Part 3: Supplementary require-ments for electro-mechanical blood pressure measuring systems. 1997.
- Slovak Office of Standards, Metrology and Testing. Decree No 210/2000 Coll. on measuring instruments and metrological control as amended [in Slovak]. 2010.
- FLUKE Biomedical. BP Pump 2 Non-Invasive Blood Pressure Simulator and Tester. [cited 9. 4. 2017]. Available at: https://www.flukebiomedical.com/sites/default/files/resources/ bppump2_ENG_D_W.PDF
- FLUKE Biomedical. ProSim 8 Vital Signs Simulator. [cited 9. 4. 2017]. Available at: https://www.flukebiomedical.com/sites /default/files/resources/Prosim8_ENG_I_W.PDF
- Lilliefors H. On the Kolmogorov–Smirnov test for normality with mean and variance unknown. Journal of the American Statistical Association 1967;62:399–402.
- Hollander M, Wolfe DA. Nonparametric Statistical Methods. 2nd ed. New York: Wiley-Academy; 1999.
- FLUKE Biomedical. ProSim 8 NIBP test optimization: dynamic pressure simulation and pressure leak test. [cited 9. 4. 2017]. Available at: http://support.fluke.com/biomedical/Download/ Asset/4202983_6150_ENG_A_W.PDF
- Sun Tech Medical. NIBP Simulator Limits with the Advantage OEM NIBP Module Series. [cited 9. 4. 2017]. Available at: https://www.suntechmed.com/downloads/Documents/white-papers/oem-nibp/82-0053-00_MA-Rev-B-oem-nibp-simulator-limits-w-advantage.pdf
- Amoore JN, Vacher E, Murray IC, Mieke S, King ST, Smith FE, et al. Can a simulator that regenerates physiological waveforms evaluate oscillometric non-invasive blood pressure devices? Blood pressure monitoring 2006 Apr;11(2):63–7. DOI: 10.1097/01.mbp.0000200482.72410.e2
- Riedel W, Mieke S, Seemann R, Ittermann B. A simulator for oscillometric blood-pressure signals to test automated non-invasive sphygmomanometers. Review of Scientific Instruments 2011 Feb 28;82(2):024303-1–7. DOI: 10.1063/1.3549803
- Slovak Office of Standards, Metrology and Testing. Decree No 161/2019 Coll. on measuring instruments and metrological control as amended [in Slovak]. 2019.
Štítky
BiomedicínaČlánek vyšel v časopise
Lékař a technika
2020 Číslo 1
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