Validation of the ANDON KD-595 automated upper-arm blood pressure monitor according to the universal standard.
Blood Press Monit
; 29(2): 103-106, 2024 Apr 01.
Article
en En
| MEDLINE
| ID: mdl-38193382
ABSTRACT
OBJECTIVE:
To validate the ANDON KD-595 automated upper-arm blood pressure monitor for clinical use and self-measurement blood pressure measurement according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard.METHODS:
Same left-arm blood pressure was sequentially measured in 90 qualified adult participants and compared with a standard mercury sphygmomanometer. A total of 270 comparison pairs were obtained and analyzed according to the universal standard.RESULTS:
For the validation Criterion 1 of the universal standard, the mean ± SD of the differences between the test device and reference blood pressure readings was 0.96â ±â 5.35 and 0.82â ±â 5.08â mmHg for SBP and DBP, respectively. For Criterion 2, the SDs of the averaged blood pressure differences between the test device and reference blood pressure per subject were 4.84 and 4.64â mmHg (with maximum allowed SDs of 6.87 and 6.89â mmHg) for SBP and DBP, respectively.CONCLUSION:
The ANDON KD-595 automated upper-arm blood pressure monitor passed all the validation requirements according to the AAMI/ESH/ISO Universal Standard and can be recommended for clinical use and self-measurement blood pressure measurement in the general population.
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Monitores de Presión Sanguínea
/
Hipertensión
Límite:
Adult
/
Humans
Idioma:
En
Revista:
Blood Press Monit
Asunto de la revista:
ANGIOLOGIA
Año:
2024
Tipo del documento:
Article