Key result
CONTEC08C automated upper-arm sphygmomanometer meets ISO validation criteria for SBP and DBP accuracy.
Why the study?
This study was conducted to assess the accuracy of the CONTEC08C automated oscillometric upper-arm sphygmomanometer in adults for clinical use in accordance with the ISO 81060-2:2018 standard.
Does the CONTEC08C automated oscillometric upper-arm sphygmomanometer accurately measure blood pressure in adults compared to reference measurements?
Cross-Sectional (n=85)
Does the CONTEC08C automated oscillometric upper-arm sphygmomanometer accurately measure blood pressure in adults compared to reference measurements?
The CONTEC08C oscillometric upper-arm blood pressure monitor meets ISO 81060-2:2018 accuracy requirements and is recommended for clinical use in adults.
Answers are grounded in this paper and cite their sources.
Extends device validation data for CONTEC08C; leaves open generalizability across diverse adult populations and settings.
This study aimed to assess the accuracy of the CONTEC08C automated oscillometric upper-arm sphygmomanometer in adults for clinical use in accordance with the ISO 81060-2:2018 standard. A total of 90 normotensive and hypertensive participants aged 18-75 years were recruited, and 85 were analyzed to evaluate the accuracy of the CONTEC08C oscillometric upper-arm sphygmomanometer using the same arm sequential validation method and a standardized protocol. The mean ± standard deviation (SD) of the differences between the test device and reference blood pressure (BP) measurements was 0.5 ± 3 mmHg for SBP and 0.4 ± 3.5 mmHg for DBP, meeting validation criterion 1. For validation criterion 2, the SD of the averaged differences between the test device and reference BP measurements per subject was 1.81/2.41 mmHg (systolic/diastolic). The CONTEC08C oscillometric upper-arm blood pressure monitor fulfilled the requirements of the ISO 81060-2:2018 standard in adults in the clinical setting and can therefore be recommended for safe clinical use.
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Chen et al. (2025) conducted a cross-sectional in Normotension and hypertension (n=85). CONTEC08C automated oscillometric upper-arm sphygmomanometer vs. Reference blood pressure measurements was evaluated on Accuracy according to ISO 81060-2:2018 standard (mean ± SD of differences between test device and reference). The CONTEC08C automated oscillometric upper-arm sphygmomanometer met ISO 81060-2:2018 validation criteria with mean differences of 0.5 ± 3 mmHg for SBP and 0.4 ± 3.5 mmHg for DBP.
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