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. 2023 Apr 1;28(2):109-112.
doi: 10.1097/MBP.0000000000000639. Epub 2023 Feb 17.

Validation of the Aktiia blood pressure cuff for clinical use according to the ANSI/AAMI/ISO 81060-2:2013 protocol

Jérémy Alexandre  1 , Kevin Tan  2 , Tiago P Almeida  1 , Josep Sola  1 , Bruce S Alpert  3 , Jay Shah  1
Affiliations

Validation of the Aktiia blood pressure cuff for clinical use according to the ANSI/AAMI/ISO 81060-2:2013 protocol

Jérémy Alexandre et al. Blood Press Monit. .

Abstract

Objective: Assess the accuracy and precision of the Aktiia initialization oscillometric upper-arm cuff device (Aktiia SA, Neuchâtel, Switzerland) for home blood pressure (BP) monitoring in the general population according to the American National Standards Institute / Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2:2013 standard.

Methods: Three trained observers validated BP measurements performed using the Aktiia cuff versus BP measurements performed using a standard mercury sphygmomanometer. Two ISO 81060-2 criteria were used to validate the Aktiia cuff. Criterion 1 evaluated, for both SBP and DBP, whether the mean error between BP readings performed by the Aktiia cuff and auscultation was ≤±5 mmHg, and whether the SD of the error was ≤8 mmHg. Criterion 2 assessed whether, for the SBP and DBP of each individual subject, the SD of the averaged paired determinations per subject of the Aktiia cuff and of the auscultation met the criteria listed in the table of Averaged Subject Data Acceptance.

Results: Mean differences between the Aktiia cuff and the standard mercury sphygmomanometer (criterion 1) were 1.3 ± 7.11 mmHg for SBP and -0.2 ± 5.46 mmHg for DBP. The SD of the averaged paired differences per subject (criterion 2) was 6.55 mmHg for SBP and 5.15 mmHg for DBP.

Conclusion: Aktiia initialization cuff complies with the requirements of the ANSI/AAMI/ISO guidelines and can be safely recommended for BP measurements in the adult population.

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Conflict of interest statement

The Aktiia cuff is produced (and tested) by Guangdong Transtek Medical Electronics. B.S.A. serves as a consultant for Aktiia SA. For the remaining authors, there are no conflicts of interest.

Figures

Fig. 1
Fig. 1
Illustration of the Aktiia monitor with (a) the Aktiia cuff, (b) the Aktiia bracelet and (c) the associated smartphone application to visualize SBP and DBP.
Fig. 2
Fig. 2
Bland–Altman plots comparing (a) SBP and (b) DBP measurements performed by the Aktiia cuff and the reference double-auscultation. ROIs within ±5 mmHg, ±10 mmHg and ±15 mmHg are highlighted in dark grey and light grey, respectively. The percentage of agreement for each region is shown on the bottom left of the Bland–Altman plots. The solid black line denotes the average mean of differences, while the dotted lines denote the limits of agreement (±1.96σ). ROIs, regions of interest.
See this image and copyright information in PMC

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