I. Core Comparative Verification
1. Synchronized Comparison with Medical Standards: Using the calibrated device alongside a metrologically certified medical mercury sphygmomanometer, perform alternating measurements on the same arm and in the same body position; take the average of three consecutive readings.
2. Compliance Criteria: The device passes the post-calibration accuracy check if the difference in systolic pressure is ≤±5 mmHg and the difference in diastolic pressure is ≤±3 mmHg compared to the standard device.
II. Home-Use Stability Verification
1. Standardized Operation: With the arm positioned at heart level, perform three consecutive measurements spaced two minutes apart. If the fluctuation between the three readings is ≤5 mmHg, the device's post-calibration stability meets the standard.
2. Multi-User Cross-Check: Have three healthy adults with different blood pressure ranges perform cross-measurements. If the average error for each individual falls within the acceptable range, this rules out random errors specific to one person and confirms the absence of systematic bias.
III. Hardware Functionality Review
1. Operational Check: Ensure the cuff inflates and deflates smoothly without air leaks or erratic value fluctuations, and that the display shows no error codes; confirm that hardware functions have fully returned to normal.
2. Load Simulation: Use a rigid water bottle to simulate pressure load and initiate inflation; observe that the pressure reading rises steadily without abnormal fluctuations to verify the proper functioning of the internal air pump and sensors.
IV. Long-Term Tracking Verification
Perform standardized measurements at fixed times for three consecutive days post-calibration and record the values. Compare these with measurements taken at a medical facility during the same period to confirm that long-term measurement deviation remains within acceptable limits, ensuring the calibration's effectiveness is sustained.
