Blood Pressure
Conditions
Brief summary
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.
Interventions
DEVICEwrist blood pressure monitor
Comparing blood pressure measured by wrist blood pressure monitor with mercury sphygmomanometer .
Sponsors
Huawei Device Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Subjects should voluntarily participate in the clinical trial and sign the informed consent form. 2. Subjects must be willing and able to follow the investigation procedures. 3. Subjects are over 18 years old whose wrist circumference should be within 13.0-20.0 cm.
Exclusion criteria
1. 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. 2. Subject with prior allergy to nylon, fluororubber, thermoplastic polyurethane elastomer (TPU), or polyvinyl chloride (PVC) materials. 3. Subjects with prior arterial obstructive disease or arteritis. 4. Subjects who had previously undergone mastectomy. 5. Subjects with wound or wrist inflammation were measured. 6. Subjects who are receiving intravenous infusion, blood transfusion, or other catheters at the site of measurement. 7. Subjects who had eaten, drank, smoked or exercised vigorously in the 30 minutes prior to the study. 8. Subjects who have participated in other clinical trials within 30 days that may affect this trial. 9. Subjects who the investigator consider inappropriate to attend the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mean difference of systolic blood pressure | 30 minutes | mean difference of systolic blood pressure between wrist blood pressure monitor and mercury sphygmomanometer |
| mean difference of diastolic blood pressure | 30 minutes | mean difference of diastolic blood pressure between wrist blood pressure monitor and mercury sphygmomanometer |
| standard deviation of the difference of systolic blood pressure | 30 minutes | standard deviation of the difference of systolic blood pressure between wrist blood pressure monitor and mercury sphygmomanometer |
| standard deviation of the difference of diastolic blood pressure | 30 minutes | standard deviation of the difference of diastolic blood pressure between wrist blood pressure monitor and mercury sphygmomanometer |
Countries
China
Outcome results
None listed