Objective: To assess the accuracy of the Omron HEM 705 CP oscillometric device for the measurement of blood pressure in pregnancy and pre-eclampsia.
Setting: Two teaching hospitals.
Participants: Eighty-five pregnant women with a wide range of blood pressures, and 43 women with pre-eclampsia.
Methods: Evaluation was carried out according to the British Hypertension Society protocol, incorporating criteria of the Association for the Advancement of Medical Instrumentation (AAMI).
Results: Mean differences (device minus observer) for systolic blood pressure were -0.9 mmHg (SD 10) in normal pregnancy, and -2 mmHg (SD 10) in the women with pre-eclampsia. For diastolic blood pressure, Korotkoff phase V, the differences were -1.5 mmHg (SD 10), and -8 mmHg (SD 8) respectively; i.e. the device consistently under-read the diastolic blood pressure in pre-eclamptic women by a mean of 8 mmHg when compared with conventional sphygmomanometry. Korotkoff phase IV could not be accurately reproduced. According to the British Hypertension Society grading criteria, the device reached a 'B' grading in the 85 pregnant women. In pre-eclampsia only a 'C' grade was reached for systolic blood pressure, and 'D' grade for diastolic blood pressure. Accuracy criteria stipulated by the AAMI were not met in any situation.
Conclusion: The Omron HEM 705 CP does not reach acceptable accuracy criteria for blood pressure measurement when compared with trained observers in women with pre-eclampsia, as judged by the British Hypertension Society Protocol. It also failed to meet the AAMI criteria, although the methodology stipulated by the AAMI may not be applicable to a pregnancy population.