Publication details
Validation of the BTL ambulatory blood pressure monitoring NG ambulatory blood pressure monitoring device according to the Universal Standard International Organization for Standardization 81060-2:2018
| Authors | |
|---|---|
| Year of publication | 2026 |
| Type | Peer-reviewed scientific article |
| Magazine / Source | BLOOD PRESSURE MONITORING |
| MU Faculty or unit | |
| Citation | |
| web | https://journals.lww.com/bpmonitoring/abstract/9900/validation_of_the_btl_ambulatory_blood_pressure.170.aspx |
| Doi | https://doi.org/10.1097/MBP.0000000000000776 |
| Description | Original study Validation of the BTL ambulatory blood pressure monitoring NG ambulatory blood pressure monitoring device according to the Universal Standard International Organization for Standardization 81060-2:2018 David, Jana; Budinska, Xenieb; Peskova, Sarkac; Adamkova, Radkad Author Information aDepartment of Children and Adolescents, Third Faculty of Medicine, Charles University and University Hospital Kralovske Vinohrady, Prague bDepartment of Physiology, Faculty of Medicine, Masaryk University, Brno cDepartment of Pediatrics, Second Faculty of Medicine, Charles University and University Hospital Motol, Prague, Czech Republic dInternal Medicine, Cardiology and Physical Education Outpatient Clinic DRADR, Brno, Czech Republic Supplemental Digital Content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's website, www.bpmonitoring.com. Correspondence to Jan David, MD, PhD, Department of Children and Adolescents, University Hospital Kralovske Vinohrady, Srobarova 1150/50, 100 00 Prague, Czech Republic, Tel: +420 702000072; , e-mail: jan.david.medical@gmail.com, jan.david@fnkv.cz Blood Pressure Monitoring ():10.1097/MBP.0000000000000776, October 09, 2025. | DOI: 10.1097/MBP.0000000000000776 Buy SDC PAP Abstract Objective The aim of this study was to validate the BTL ambulatory blood pressure monitoring NG ambulatory blood pressure (BP) monitoring device in a general population, including children aged 4–12 years, according to the International Organization for Standardization 81060-2:2018 standard with amendments A1:2020 and A2:2024. Methods The study included both clinical and ambulatory validation. In the clinical part, 85 participants (50 adults and 35 children) underwent same-arm sequential measurements with alternating test device and reference readings. The ambulatory part involved 35 adults tested using a dynamic protocol on a bicycle ergometer with at least a 15% heart rate increase. All procedures strictly followed standard requirements, including arm circumference and BP distributions. Results The device met all validation criteria defined by the standard. In clinical testing, mean differences were –0.52 mmHg systolic and –0.39 mmHg diastolic, with standard deviations of 4.44 and 4.17 mmHg. All cuff subgroups also met criterion 1, and criterion 2 was fulfilled with standard deviations of 3.80 mmHg systolic and 3.35 mmHg diastolic, including the children subgroup. In the ambulatory validation, mean differences were –0.40 mmHg systolic and –0.50 mmHg diastolic, with standard deviations of 5.88 and 5.05 mmHg. Conclusion To our knowledge, this is the first published validation of an ambulatory BP monitoring device that fully followed the unified 81060-2:2018 standard, including amendments A1:2020 and A2:2024. The device fulfilled all clinical and ambulatory validation criteria across all required distributions and age groups, including children. |