Validation of the Raycome model M2 ambulatory blood pressure monitor in the general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard (ISO 81060-2:2018).
Blood Press Monit
; 29(3): 161-165, 2024 Jun 01.
Article
em En
| MEDLINE
| ID: mdl-38390625
ABSTRACT
OBJECTIVE:
The aim of this study was to evaluate the accuracy of the Raycome model M2 oscillometric upper-arm blood pressure (BP) monitor developed for ambulatory BP measurement in the general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-22018) at rest and during dynamic exercise.METHOD:
Subjects were recruited to fulfill the age, gender, BP and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in the general population using the same arm sequential BP measurement method. Three cuffs of the test device were used for arm circumference 18-22â cm (small), 22-32â cm (medium) and 32-42â cm (large).RESULTS:
For the general validation study, 106 subjects were recruited and 85 were analyzed. For validation criterion 1, the meanâ ±â SD of the differences between the test device and reference BP readings was 0.5â ±â 6.2/-0.2â ±â 5.1â mmHg (systolic/diastolic). For criterion 2, the SD of the mean BP differences between the test device and reference BP per subject was 5.23/4.50â mmHg (systolic/diastolic). In the ambulatory validation study ( N â =â 35), the mean difference was 0.4â ±â 5.9/-1.1â ±â 5.8â mmHg. The Raycome model M2 performed well against the standard in both the general and ambulatory validations and the Bland-Altman plots did not show any systematic variation in the error.CONCLUSION:
These data show that the Raycome model M2 monitor meets the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-22018) and in the ambulatory setting, indicating its suitability for measuring BP in the general population.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Monitorização Ambulatorial da Pressão Arterial
Idioma:
En
Ano de publicação:
2024
Tipo de documento:
Article