This study was a single-center, open-ended, self-controlled clinical study . Same armsequential method was used to measure the blood pressure of the subjects，inclusion of ≥85 subjects aged 12 years or older who met the enrollment criteria.In accordance with the "Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018/Amd 1:2020)",the purpose of this study was to compare the blood pressure and pulse rate measured by an electronic sphygmomanometer with those measured by a reference sphygmomanometer (an upper-arm noninvasive auscultatory sphygmomanometer) and by palpation of the radial artery, and then to evaluate the accuracy and safety of the measurement of systolic blood pressure, diastolic blood pressure, and pulse rate by a fully automated electronic sphygmomanometer for medical use (Model No. YE990), which is manufactured by Jiangsu Yuyue Medical Equipment Co.
Both sexes; at least 30% of the subjects are male and at least 30% of the subjects are female.
Subject's age > 12 years.
At least 20% of the subjects should have arm circumference within each quarter interval of the total arm circumference range;
At least 10% of the subjects should have arm circumference within the upper one-eighth interval of the total arm circumference range;
None
Healthy people over 12 years of age who meet the criteria for admission to the platoon
Case-crossover
Prospective
Not listed
To evaluate the accuracy of the arm-type electronic blood pressure monitor (Model: YE660D) in measuring systolic blood pressure, diastolic blood pressure and pulse rate in adults aged 12 years and above.
Evaluate the relationship between the mean and standard deviation of error, the agreement between the measured and reference blood pressure values, and the relationship between arm circumference and measurement error.Reference standard: 255 sets of data from 85 subjects were calculated and compared separately for systolic and diastolic blood pressure, with a mean deviation of not more than ±5 mmHg and a standard deviation of not more than 8 mmHg.
Collect and document the occurrence of adverse events and device defects in subjects during use
1. Incidence of adverse events; 2. Incidence of device defects.
Clinical use performance evaluation is mainly product stability evaluation
Evaluation Item 1: Electronic Sphygmomanometer Turning On and Off Evaluation item 2: Whether the device was turned off automatically during the checking process Evaluation item 3: Whether there is any abnormal interruption due to the machine during the inspection process. Evaluation item 4: Whether inflation and exhaust failure occurs during the inspection process Evaluation item 5: Whether air leakage occurred during the inspection process
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