Annemarie de Greeff1, Andrew H Shennan2. 1. Accuracy Assessed Medical Devices CC, Kimberley, South Africa. 2. Department of Women and Children's Health, School of Health Course Sciences, King's College London, London, UK.
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.
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.
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