Blood pressure measurement is the most common measurement that is made in clinical practice. There is a large market for
commercially available blood pressure devices, and in Germany alone, approximately 1.2 million blood pressure devices are sold annually for personal use. However, there are claims that a majority of blood pressure devices available on the European Union market have not been validated.
Objectives: The purpose of this study was to examine differences between external and internal cuffs when using an oscillometric waveform simulator; to investigate blood pressure device validity and differences within models; and to examine how a simulator
could be used in the acquisition of blood pressure devices,
before these devices are implemented in the clinical domain.
Methods: Two different models of blood pressure devices, 10 devices per model, were utilized. A simulator was used to generate 8 physiological oscillometric waveforms.
Results: Differences between cuffs did not exceed acceptable measurement limits of ± 3 mmHg, however, many devices were excluded when using the internal simulator cuff. Neither model was able to produce valid measurements within ± 3 mmHg for all 8 simulations. Measurement errors ranged from -3 to 4 mmHg (Model 1), and -8 to 6 mmHg (Model 2).
Differences within models showed significant differences for both Model 1 and Model 2.
Conclusions: Many factors may have had an influence on the validity of the measurements obtained with both models, including: simulator and blood pressure device employment of differing proprietary algorithms, and measurement variability caused by a lack of pressure transducer calibration. Further studies are needed to increase the understanding of the oscillometric method and oscillometric waveforms, so that improved blood pressure devices and oscillometric waveform simulators can be designed.