Validation of the Spacelabs 90227 OnTrak device according to the European and British Hypertension Societies as well as the American protocols

Objective To assess the static device accuracy of the Spacelabs 90227 OnTrak according to the three most recognized validation protocols, in both adults and children. Methods Subjects were recruited and data gathered and analysed according to the European Society of Hypertension (ESH-IP2), the British Hypertension Society (BHS) and the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Standards Organization (ANSI/AAMI/ISO) protocols. Results The device achieved a mean difference +/- SD between observers and device for SBP/DBP was 0.9 +/- 7/-1.4 +/- 6 mmHg (ESH-IP2) and 1.7 +/- 8/-1.5/6 mmHg (BHS) Grade A/A. For the ANSI/AAMI/ISO protocol, the average device-observer difference for SBP/DBP was 0.4 +/- 7/-1.5 +/- 7 mmHg fulfilling the two criteria of the protocol. Conclusion The Spacelabs 90227 OnTrak device achieved the criteria of all three recognised validation protocols and can therefore be recommended for clinical use as a static device.