A Clinical Evaluation of Omron Digital Blood Pressure Monitor

N/ACompletedNCT03130686

Omron Healthcare Co., Ltd.92 enrolled

Overview

The purpose of this study is to measure the blood pressure level of the patients, using a cuff ranged 17 - 50 cm.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Blood Pressure

Interventions

OMRON blood pressure monitor HEM-9210TDEVICE

To measure systolic blood pressure, diastolic blood pressure and pulse rate in patients.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Upper arm circumference: 17-50cm Exclusion Criteria: * Patients who has arrhythmia. * When body motion is observed during measurement. * Korotkoff sound is poor quality. * Patient's arm circumference is outside cuff range. * Patient's auscultatory systolic blood pressure readings differ by more than 12mmHg. and patient's diastolic blood pressure readings differ by more than 8mmHg. * Patients stated they did not wish to continue with the study and it is stopped before completion.

Locations (1)

OMRON HEALTHCARE CO., Ltd.

Mukō, Japan

Outcomes

Primary Outcomes

Verify the accuracy of measure functions of device

The aims of this study was to assess the accuracy of the Omron blood pressure monitor according to the ANSI/AAMI/ISO81060-2:2013. And it is analyzed and evaluated at least 85 patients based on the AAMI/ANSI/ISO81060-2:2013.

Time frame: 30 days

Data from ClinicalTrials.gov

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