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

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Abstract
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.