Validation of the SAA-102 home blood pressure monitor according to the protocols of the European Society of Hypertension, the Association for the Advancement of Medical Instrumentation and the British Society of Hypertension
Abstract:These data show that the SAA-102 device satisfies ESH, AAMI, and BHS protocols for both SBP and DBP and may be recommended for everyday use for BP monitoring at home and in clinical practice.
“…BP distribution for ESH and AAMI was according to the protocols. As indicated by us and other authors [6], however, it is extremely difficult to obtain correct distribution for the BSH protocol. In fact, we had less than expected participants in the extreme DBP group (> 110 mmHg): five instead of eight participants.…”
Section: Procedures and Protocolsmentioning
confidence: 93%
“…As indicated previously, several other research groups encountered similar problems recruiting participants with extreme values of DBP [6]. Following their experience, we have adopted the distribution of DBP similar to other validation teams, as reported previously [6].…”
Section: Saw-102 Validationmentioning
confidence: 95%
“…The limits of agreement between the device and the standard were plotted using the BlandAltman's method, as described previously [6]. All BP differences are expressed by media ± standard deviation, as requested by AAMI protocol.…”
Section: Analysis Of Datamentioning
confidence: 99%
“…We have recently evaluated other BP arm devices of the same company, which received excellent grading [6]. These results, along with scarcity of recommendable wrist BP devices, prompted us to evaluate the accuracy of SAW-102 according to the protocols of the BSH, ESH, and AAMI as a main objective of our study [3][4][5].…”
This study demonstrated that SAW-102 meets the BHS, ESH, and AAMI standards when measurements are done at the heart level and when the manufacturer's specifications, regarding wrist circumference, are respected. Our data also indicate that exceeding 19.5 cm wrist circumference is accompanied by dramatic decrease of the accuracy of the device.
“…BP distribution for ESH and AAMI was according to the protocols. As indicated by us and other authors [6], however, it is extremely difficult to obtain correct distribution for the BSH protocol. In fact, we had less than expected participants in the extreme DBP group (> 110 mmHg): five instead of eight participants.…”
Section: Procedures and Protocolsmentioning
confidence: 93%
“…As indicated previously, several other research groups encountered similar problems recruiting participants with extreme values of DBP [6]. Following their experience, we have adopted the distribution of DBP similar to other validation teams, as reported previously [6].…”
Section: Saw-102 Validationmentioning
confidence: 95%
“…The limits of agreement between the device and the standard were plotted using the BlandAltman's method, as described previously [6]. All BP differences are expressed by media ± standard deviation, as requested by AAMI protocol.…”
Section: Analysis Of Datamentioning
confidence: 99%
“…We have recently evaluated other BP arm devices of the same company, which received excellent grading [6]. These results, along with scarcity of recommendable wrist BP devices, prompted us to evaluate the accuracy of SAW-102 according to the protocols of the BSH, ESH, and AAMI as a main objective of our study [3][4][5].…”
This study demonstrated that SAW-102 meets the BHS, ESH, and AAMI standards when measurements are done at the heart level and when the manufacturer's specifications, regarding wrist circumference, are respected. Our data also indicate that exceeding 19.5 cm wrist circumference is accompanied by dramatic decrease of the accuracy of the device.
“…However, this type of equipment must be evaluated according to international criteria, such as those suggested by the British Hypertension Society (BHS) [14] and the Association for the Advancement of Medical Instrumentation (AAMI) [3]. Furthermore, the majority of validation data originate from adult samples [2,6,16,20,26] information, and although several studies have been conducted with children [1,4,11,21,24,25], there are few studies that have examined the sensitivity and specificity of these types of devices jointly with a validation of BHS [14] and AAMI [3] protocols with this population. Thus, the purpose of the present study was to evaluate the accuracy of the Omron MX3 Plus (model HEM-742-E) blood pressure monitor among adolescents according to BHS [14] and AAMI [3] standards.…”
This study analyzed the accuracy/agreement of the Omron MX3 monitor on 165 adolescents. Blood pressure was measured by the automatic monitor connected in Y with the mercury column (three consecutive and simultaneous measures). The independent measures were analyzed, and the mean differences between systolic and diastolic measures for both methods were calculated and compared with British Hypertension Society (BHS) and Association for the Advancement of Medical Instrumentation (AAMI) criteria. The automatic monitor received the highest degree of BHS recommendations for systolic and diastolic blood pressures according to the BHS. The median (25th and 75th) difference between the observer and the monitor measurements was -2 (-6 and 1) mmHg for systolic and 0 (-3 and 1) mmHg for diastolic pressures. The monitor also satisfies the AAMI standard for the studied population. In conclusion, the Omron MX3 Plus monitor can be considered reliable and valid for clinical practice and is in accordance with BHS and AAMI criteria.
Datascope Accutorr Plus™ (Paramus, NJ, USA) satisfies BHS and AAMI validation protocols for both systolic and diastolic BP and may be recommended for everyday use for BP monitoring at home and in clinical use for adult population.
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