Key result
New mechanical test bench simultaneously calibrates blood pressure devices with ~0.11 mmHg measurement uncertainty.
Why the study?
Due to inaccuracies in different BP measuring devices, calibration is a major concern, and current calibration, testing, and validation require rigorous methods with complex clinical trials.
The developed mechanical test bench allows for simultaneous, cost-effective testing and calibration of up to 20 blood pressure measuring devices with high precision.
May enable efficient high-precision BP device calibration; extends metrology capabilities but leaves clinical accuracy impact open.
Blood pressure (BP) measurement is an important physiological parameter for human health monitoring, which plays a significant role in the diagnosis of many incurable diseases. However, due to inaccuracies in the different types of BP measuring devices, the calibration of these BP measuring instruments is a major concern for a medical practitioner. Currently, these devices' calibration, testing, and validation are performed using rigorous methods with complex clinical trials and following the available documentary standards. This article describes the design and development of an indigenous mechanical test bench (MTB) system for the testing and calibration of multiple BP devices, as per International Organization of Legal Metrology (OIML) recommended documents e.g., OIML R 16-1 and OIML R 16-2. The developed system can test and calibrate 20 BP devices, simultaneously. The traceability of the developed MTB is established by performing its calibration against the Air Piston Gauge, a national primary vacuum standard. The estimated expanded measurement uncertainty evaluated is found to be ±0.11 mmHg, which is almost one order better than the measurement uncertainty required for the test and calibration of BP measuring instruments as per standard. The MTB has successfully been used to test and calibrate several BP measuring instruments. The data of one such device is reported herein as an indicator of the performance process. The calibration of these BP measuring instruments was performed in the static mode, and the estimated expanded measurement uncertainty was found to be ±1.25 mmHg. The developed MTB system would prove to be an excellent instrument for calibration laboratories, hospitals, regulatory agencies, and other users to test and calibrate 20 BP measuring devices simultaneously and cost-effectively.
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Kumar et al. (2023) studied Blood pressure measurement. Mechanical test bench (MTB) system vs. Air Piston Gauge was evaluated on Estimated expanded measurement uncertainty. A newly developed mechanical test bench system can simultaneously test and calibrate 20 blood pressure devices with an estimated expanded measurement uncertainty of ±0.11 mmHg.
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