Bench and ambulatory field evaluation of the A & D TM-2420 automated sphygmomanometer

Abstract

Adequate evaluation of automated sphygmomanometers, in terms of safety, accuracy, mechanical reliability, patient acceptability and ability to record ambulatory blood pressure is essential before these devices are used in clinical practice and in clinical trials. We have evaluated the accuracy and performance of the A & D TM-2420 automated sphygmomanometer, an auscultatory device designed for ambulatory blood pressure recording. Four devices were tested for accuracy by simultaneous comparison against two experienced observers using standard mercury column sphygmomanometers. Two of these devices developed faults that precluded complete evaluation. One of the remaining devices met and one failed to meet the somewhat liberal criteria for accuracy recommended by the American Association for the Advancement of Medical Instrumentation, the current standard for evaluation (mean difference of ≤5 mmHg and standard deviation of differences ≤8 mmHg). The mean differences (standard deviation of differences) between observers for simultaneous triplicate observations of systolic/diastolic pressure in 50 subjects, including 35 hypertensives, were 0.8 (3.0)/ -0.6 (2.4) mmHg. In comparison, the differences between each device and each observer were: device 11, observer 1, -6.4 (5.4)/ -6.3 (9.9); device 11, observer 2, -5.6 (4.7)/-7.0 (10.4); device 12, observer 1, -4.9 (5.2)/-4.0 (7.5); device 12, observer 2, -4.1 (4.9)/ -4.5 (7.7) mmHg. Ambulatory trials were carried out with a further 10 devices. Of these, seven developed faults requiring their return to the supplier. Numerous additional problems were encountered with microphones, cuffs, leads and connections, the processing unit, error algorithms and data-handling software. The device was not capable of making truly ambulatory recordings. We do not confirm the previously favourable, but limited, evaluation of this device. We stress the vital importance of subjecting a number of devices to benchtesting for accuracy, and the need to undertake extensive 'field' testing before any devices can be considered suitable for ambulatory recording. Exercise testing under laboratory conditions is not an adequate substitute for true ambulatory evaluation.