Clinical Trial of Wrist Blood Pressure Monitor in Conformance With the EN ISO 81060-2:2019/A1:2020 Standard

Study Overview
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Brief Summary
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The accuracy and safety of wrist blood pressure (model: MLY-B10) is evaluated according to the requirement of EN ISO 81060-2:2019/A1:2020.

Official Title
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Clinical Trial on the Effectiveness of Blood Pressure Function of Wrist Blood Pressure Monitor

Conditions
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Blood Pressure

Intervention / Treatment
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* Device: wrist blood pressure monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects should voluntarily participate in the clinical trial and sign the informed consent form. Subjects must be willing and able to follow the investigation procedures. Subjects are over 18 years old whose wrist circumference should be within 13.0-20.0 cm. Exclusion Criteria: Subjects with serious arrhythmias (atrial fibrillation, atrial flutter, ventricular flutter, ventricular fibrillation, ventricular tachycardia, borderline tachycardia, sinus arrest, pathological sinus syndrome, pacemaker rhythm) showed by electrocardiogram during screening period. Subject with prior allergy to nylon, fluororubber, thermoplastic polyurethane elastomer (TPU), or polyvinyl chloride (PVC) materials. Subjects with prior arterial obstructive disease or arteritis. Subjects who had previously undergone mastectomy. Subjects with wound or wrist inflammation were measured. Subjects who are receiving intravenous infusion, blood transfusion, or other catheters at the site of measurement. Subjects who had eaten, drank, smoked or exercised vigorously in the 30 minutes prior to the study. Subjects who have participated in other clinical trials within 30 days that may affect this trial. Subjects who the investigator consider inappropriate to attend the trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blood pressure measured by wrist blood pressure monitor and mercury sphygmomanometer<br> | Device: wrist blood pressure monitor<br>* Comparing blood pressure measured by wrist blood pressure monitor with mercury sphygmomanometer .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean difference of systolic blood pressure | mean difference of systolic blood pressure between wrist blood pressure monitor and mercury sphygmomanometer | 30 minutes | 
| mean difference of diastolic blood pressure | mean difference of diastolic blood pressure between wrist blood pressure monitor and mercury sphygmomanometer | 30 minutes | 
| standard deviation of the difference of systolic blood pressure | standard deviation of the difference of systolic blood pressure between wrist blood pressure monitor and mercury sphygmomanometer | 30 minutes | 
| standard deviation of the difference of diastolic blood pressure | standard deviation of the difference of diastolic blood pressure between wrist blood pressure monitor and mercury sphygmomanometer | 30 minutes |