Validation of the OMRON Automated Oscillometric Blood Pressure Monitoring Device HEM 7156 using the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018)

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Background: Blood pressure (BP) is a vital sign that is essential in the management of hypertension, thus, there is a need for accurate measurement of BP. This will allow for proper diagnosis and management of hypertension preventing cardiovascular morbidity and mortality among Filipino patients. Methodology: This validation study utilized the US Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) protocol for BP monitors. A total of eighty-five (85) participants had their BP measured using both the HEM 7156 and a validated aneroid sphygmomanometer. The same-sequential BP measurement was recommended to be used and a total of nine readings were collected per individual. The mean average of BP and standard deviation were extracted from the measurements. The AAMI/ESH/ISO recommends the use of certain criteria for individual BP readings (criterion 1) and individual participants (criterion 2). Appropriate statistical analysis was used for other demographic data. Results: The participants had an average age of 34 years, more than half were females, and not diagnosed with hypertension. Individuals who were diagnosed with hypertension had no other comorbidities and were on single pill only. The average arm circumference was 26.9 cm. Blood Pressure (BP) readings were adequate based on the protocol. Validity results showed that for criterion 1, systolic blood pressure (SBP) difference was 3.4 ± 7.4 mmHg, while diastolic blood pressure (DBP) was 2.0 ± 8.0 mmHg. The results for criterion 2 showed for SBP was 3.3 ± 5.3 mmHg, while DBP was 1.9 ± 6.6 mmHg. The results satisfied a passing grade on the validation protocol set by the AAMI/ESH/ISO. Conclusion: This study showed that OMRON HEM 7156 is validated as a BP apparatus and may be recommended for Philippine use. Keywords: oscillometric device, BP monitor, hypertension, elevated BP, OMRON HEM 7156

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.