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In this study, according to the latest released ISO 81060-3:2022 standard requirements, non-invasive blood pressure measurement by cuff at the start and the end time points will be used as oCareTM BP100 start-to-end blood pressure calibration. The invasive arterial catheter (A-line) blood pressure measurement will be used as a reference invasive blood pressure monitor (BPM) equipment. The purpose of the study is to evaluate the stability of the device under evaluation (DUE) and its performance in blood pressure change tracking.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A Photoplethysmography-Based Continuous Automated Non-Invasive Sphygmomanometer | Device | The investigation medical device under evaluation is oCareTM BP 100, a non-invasive continuous blood pressure monitoring system developed by Taiwan Biophotonic Co. (tBPC). The main function is to use a fingerclip sensor to receive PPG signals and collect continuous blood pressure values and uninterruptedly within the initialization time. In this study, according to the latest released ISO 81060-3:2022 standard requirements, non-invasive blood pressure measurement by cuff at the start and the end time points will be used as oCareTM BP 100 start-to-end blood pressure calibration. The A-line invasive arterial catheter blood pressure measurement will be used as a reference invasive BPM equipment. The purpose of the study is to confirm the stability of the investigational medical device under evaluation and its performance of blood pressure change tracking. |
| Measure | Description | Time Frame |
|---|---|---|
| Confirm the stability of the repeated measurements of SUT by calculating the corrected standard deviation of each analysis period | 4 hours | |
| Confirm the consistency of SUT vs. the reference BPM equipment by calculating the blood pressure change during the change evaluation interval | 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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This study will be conducted in the National Taiwan University Hospital Hsin-Chu Branch. A total of 30~40 patients are intended to be recruited.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital Hsin-Chu Branch | Hsinchu | 30059 | Taiwan |
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