March 3, 2026Blood Pressure Monitoring

Validation of the automated oscillometric upper-arm cuff home blood pressure monitor Prolife PA5 Comfort AF (BP 136A) in a general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard

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Why the study?

This study evaluated the accuracy of the automated oscillometric upper-arm cuff BP measuring device Prolife PA5 Comfort AF (BP 136A) for home use according to the AAMI/ESH/ISO Universal Standard.

Does the Prolife PA5 Comfort AF (BP 136A) home blood pressure monitor accurately measure blood pressure compared to reference readings in a general population?

Population

85 analyzed individuals from a general population

Comparison

Prolife PA5 Comfort AF (BP 136A) vs reference BP readings

Design

Validation study using the same arm sequential measurement method

Authors

AMAriadni Menti VNVasileios NtousopoulosNational and Kapodistrian University of Athens PLPetroula LempidakiNational and Kapodistrian University of Athens

Discussion

Member takes

Implication

Clinicians can recommend the Prolife PA5 for home BP monitoring; confirms it meets AAMI/ESH/ISO universal accuracy standards in general populations.

Key Points

The mean difference between the test device and reference readings was -2.1 ± 7.5 mmHg for systolic pressure, indicating accuracy.
The study adhered to the AAMI/ESH/ISO Universal Standard and included 128 individuals with specific age and arm size criteria.
The Prolife PA5 Comfort AF (BP 136A) showed satisfactory performance against the validation criteria laid out in the guidelines.
This validation supports the clinical recommendation for the automated oscillometric blood pressure monitor for home use.

Structured PICO

Does the Prolife PA5 Comfort AF (BP 136A) home blood pressure monitor accurately measure blood pressure compared to reference readings in a general population?

Population

85 analyzed individuals from a general population (mean age 54.9 ± 15.0 years, 42% men, arm circumference 31.7 ± 5.4 cm, range 22.5-41.9 cm)

Intervention

Blood pressure measurement using the Prolife PA5 Comfort AF (BP 136A) automated oscillometric upper-arm cuff home blood pressure monitor

Comparator

Reference blood pressure readings using the same arm sequential measurement method

Outcome

Accuracy of blood pressure measurement according to AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) Criterion 1 and 2surrogate

The Prolife PA5 Comfort AF (BP 136A) home blood pressure monitor fulfills AAMI/ESH/ISO Universal Standard requirements for accuracy in a general population and can be recommended for clinical use.

Cite This Study

Menti et al. (2026) studied this question.

synapsesocial.com/papers/69a75a67c6e9836116a2027d https://doi.org/10.1097/mbp.0000000000000793

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Implication

Clinicians can recommend the Prolife PA5 for home BP monitoring; confirms it meets AAMI/ESH/ISO universal accuracy standards in general populations.

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

Also Consider

Also Consider