Accuracy of a Blood Pressure Measuring Mobile Device in Volunteers

M- HEALTHCARE Confirmatory Clinical Trials Used for Measurement of the ABP for the Accuracy and Safety Assessment of the Module Measuring Blood Pressure

The accuracy and safety of blood pressure module of new mobile device (M- HEALTHCARE device) is evaluated according to Korean FDA guidelines in 100 healthy volunteers.

Inclusion Criteria:

1. Participants whose systolic blood pressure <=110 should be at least 10% of whole cohort
2. Participants whose systolic blood pressure >=160 should be at least 10% of whole cohort
3. Participants whose diastolic blood pressure >=100 should be at least 10% of whole cohort
4. Participants whose diastolic blood pressure <=70 should be at least 10% of whole cohort
5. Participants whose arm circumference are between 20cm and 30cm should be 25 - 50% of whole cohort
6. Participants whose arm circumference are between 30cm and 40cm should be 50 - 75% of whole cohort

Exclusion Criteria:

1. heart disease with abnormal rhythm
2. peripheral vascular anomaly or disease
3. inadequate to be applied blood pressure cuff (e.g. trauma on arm)
4. pregnant or lactating women