The purpose of the task is to check whether a patient simulator can be used instead of real people in checking the accuracy of blood pressure monitors. We looked for which conditions of the standards need to be met so that the performance of blood pressure monitor verification using a simulator can be compared with real clinical validation. If the sex and age distribution of specimens in the measurement cannot be met when validating the blood pressure monitor with a simulator, the requirement for different blood pressure values can be met. Using the simulator, we can set any blood pressure values, ie even those that would be difficult to find in real people.
We used the Clinical Dynamics SmartArm NIBP simulator to test three blood pressure monitors from Omron, Microlife and Lanaform. We performed a validation procedure and made 85 measurements of different blood pressure values for each device. Measurements were performed on the original gauge cuffs and two additional cuffs, which were used on all three devices. The results of clinical validation were compared by device and cuffs. We have proven that it is possible to check the accuracy of an individual blood pressure monitor relatively easily and quickly using a simulator. For clinical validation of the blood pressure device, we can use a patient simulator and quickly check its accuracy and compliance with regulations. Under the conditions prescribed in the standards (error less than 5 mmHg), only one device would fully pass the clinical validation process and the other two would not. The Omron blood pressure monitor would be the only one to perform the entire clinical validation process of the device as it has a smaller measurement error (2 mmHg) than specified in the standards (5 mmHg). With the help of a simulator, we found out in a very simple and quick way that it is also important what the cuff of the device is.
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