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The accuracy and safety of the Wrist Ambulatory Blood Pressure Recorder (Model: LCA-B10) were assessed according to the requirements of EN ISO 81060-2:2018 + AMD1:2020.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood pressure measured by wrist ambulatory blood pressure monitor and mercury sphygmomanometer | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wrist Ambulatory Blood Pressure Monitor | Device | Comparing blood pressure measured by wrist blood pressure monitor with mercury sphygmomanometer . |
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| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure mean deviation and standard deviation- evaluation criterion 1 | The mean deviation and standard deviation between the blood pressure values measured by the investigational device and those obtained using the auscultatory method with the reference device. This calculation is performed on valid data pairsof subjects (n≥255). Evaluation criterion 1: The blood pressure mean deviation should not exceed ±5mmHg, and the standard deviation should not exceed 8mmHg. | 30 minutes |
| Blood pressure mean deviation and standard deviation- evaluation criterion 2 | The mean deviation and standard deviation between the blood pressure values measured by the investigational device and those obtained using the auscultatory method with the reference device. This calculation is performed on the valid data group of all subjects (m≥85). Evaluation criterion 2: The blood pressure standard deviation within the valid data group (m ≥ 85) should not exceed the maximum allowable standard deviation corresponding to the mean deviation listed in Criterion 2 in section 5.2.4.1.2 b of ISO 81060-2:2018+AMD1:2020. | 30 minutes |
| The mean deviation and standard deviation of blood pressure measurements under ambulatory blood pressure monitoring | The mean deviation and standard deviation of the blood pressure within the valid data group are calculated to evaluate whether the clinical accuracy of the investigational device meets the requirements outlined in ISO 81060-2:2018+AMD1:2020, specifically in section 5.2.4.1.2a). The blood pressure mean deviation should not exceed ±5mmHg, and the standard deviation should not exceed 8mmHg. | 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bin Peng | Chenzhou | Hunan | 423000 | China |
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