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

Annemarie de Greeff; Andrew H. Shennan

doi:10.1097/MBP.0000000000000424

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

Annemarie de Greeff, Andrew H. Shennan

Women & Children's Health

Research output: Contribution to journal › Article › peer-review

17 Citations (Scopus)

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.

Original language	English
Pages (from-to)	110-114
Number of pages	5
Journal	BLOOD PRESSURE MONITORING
Volume	25
Issue number	2
DOIs	https://doi.org/10.1097/MBP.0000000000000424
Publication status	Published - 1 Apr 2020

Keywords

American National Standards Institute
Association for the Advancement of Medical Instrumentation
Automated blood pressure measurement
British Hypertension Society
Device validation
European Hypertension Society
International Standards Organization protocol

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10.1097/MBP.0000000000000424

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

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.",

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AU - de Greeff, Annemarie

AU - Shennan, Andrew H.

PY - 2020/4/1

Y1 - 2020/4/1

N2 - 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.

AB - 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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KW - International Standards Organization protocol

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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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