ESH-IP2 Validation of the Hingmed WBP-02A in oscillometry mode, in a general population. Validation of the Hingmed WBP-02A upper arm oscillometric monitor for ambulatory blood pressure measurement in a general population, according to the European Society of Hypertension International Protocol revision 2010 Claudio Fania,MD, Leonardo Vezzù,RN, Ilaria Lazzaretto,RN, Paolo Palatini, MD Keywords: Validation, device, oscillometric, blood pressure, ambulatory. For Claudio Fania, Leonardo Vezzù, and Ilaria Lazzaretto: Casa di Cura Villa Maria, via delle Melette, 20, 35138 Padova, Italy For Paolo Palatini: via San Fris, 121, 31029 Vittorio Veneto, Italy Correspondence to Doctor Claudio Fania, Casa di Cura Villa Maria, via delle Melette, 20, 35138 Padova, Tel: 049 8711144; e-mail: [email protected] Abstract The Hingmed WBP-02A, an upper arm oscillometric monitor, for ambulatory BP measurement was validated in a general population, according to the European Society of Hypertension International Protocol revision 2010. The protocol requirements were followed precisely. The device passed all of the requirements fulfilling the standards of the protocol. Thus, the WBP-02A device is recommended for clinical use in the adult general population. Device Details Brand Shenzhen Hingmed Medical Instrument Co., Ltd Fully Automatic Small Adult: 18.0 cm to 26.0 cm, Standard Adult: 22.0 cm to 32.0 cm, Large Adult: 26.0 cm to 36.0 cm and other cuffs: 30.0 cm to 43.0 cm Methodology Familiarisation Forty test measurements were carried out. No problems were encountered. Recruitment The WBP-02A device was evaluated in 37 adult individuals with BPs in the ranges required by the protocol. The participants were recruited from the outpatient clinics, wards, and from among the healthcare personnel of the Hospital Villa Maria, Padua, Italy. Four participants were excluded because their BP was within the BP ranges already completed, leaving an overall number of 33 participants. There was some difficulty in recruiting patients with BP in the high ranges, but apart from this there was no problem.

ESH-IP2 Validation of the Hingmed WBP-02A in oscillometry mode, in a general population. Screening and Recruitment Details Screening and Recruitment Recruitment Ranges Total Screened Total Excluded Ranges Complete Ranges Adjustment Device Failure Poor Quality Sounds Observer Disagreement Other Reasons Cuff Size Unavailable Medium High Total Recruited Medium High The European Society of Hypertension International Protocol revision 2010 for the validation of blood pressure measuring devices in adults was followed precisely.[1] Overseen by an independent supervisor, measurements were recorded by...

ESH-IP2 Validation of the Hingmed WBP-02A in oscillometry mode, in a general population. Validation Results Part 1 Mean (mmHg) Pass Requirements Pass Requirements Pass Result PASS Discussion The present study demonstrated that the WBP-02A BP monitor met the ESH-IP standards for use in the general adult population because it passed all phases of the 2010 ESH revision Protocol. The recruitment of individuals in the high BP range proved to be difficult and accounted for the extra number of screened participants. Visual inspection of the device– observer discrepancies showed that the error was unrelated...

ESH-IP2 Validation of the Hingmed WBP-02A in oscillometry mode, in a general population. O’Brien E, Atkins N, Stergiou G, Karpettas N, Parati G, Asmar R, Imai Y, Wang J, Mengden T, Shennan A; on behalf of the Working Group on Blood Pressure Monitoring of the European Society of Hypertension. European Society of Hypertension International Protocol revision 2010 for the Validation of Blood Pressure Measuring Devices In Adults. Blood Press Monit 2010;15:23–38