The Rossmax (ME 701 series) upper arm device: accuracy assessment in an adult population according to the International and the British Hypertension Society protocols.

OBJECTIVE

Any device intended for blood pressure measurement should be subjected to an independent accuracy assessment. This is particularly relevant to automated oscillometric devices that do not use Korotkoff sounds to identify blood pressure. Various validation protocols have been published with the view of standardizing the acceptable level of accuracy for such devices. We evaluated the accuracy of the Rossmax (ME 701 series, Taipei, Taiwan) device according to the International protocol of the European Society of Hypertension and the British Hypertension Society (BHS) protocol.

METHODS

Local ethics committee approval was obtained and 91 participants were recruited from the staff and patients at a large teaching hospital. Two trained observers took nine sequential same arm measurements from each participant. Initially, the data from 33 participants were analysed according to the International protocol guidelines. A further 52 participants were then included to fulfil the BHS protocol requirement of 85 participants.

RESULTS

The Rossmax (ME 701 series) device passed the criteria for both the International and the BHS protocols and achieved an A/A grade. The mean difference and standard deviation for systolic and diastolic pressures according to the International protocol [-0.1 (6.2) mmHg and -2.8 (5.3) mmHg] and the BHS protocol [1.5 (7.6) mmHg and -1.2 (6.1) mmHg] also meet the requirements of the Association for the Advancement of Medical Instrumentation that is <or=5 (8) mmHg.

CONCLUSION

The Rossmax (ME 701 series) upper arm device can be recommended for clinical use in an adult population.