Validation of a non-mercury digital auscultatory device according to the European Hypertension Society protocol: Rossmax Mandaus II

Abstract

To assess the accuracy of the Rossmax Mandaus II for clinical use, according to the protocol of the European Society of Hypertension (ESH). Thirty-nine participants were recruited to fulfill the 33 participant requirement of the protocol. Nine sequential same-arm blood pressure readings were taken by trained observers alternating between simultaneous mercury sphygmomanometer readings and the device readings. The latter seven readings were analysed according to the protocol guidelines and the criteria of the Association for the Advancement of Medical Instrumentation. The device passed both phases of the ESH protocol. Out of 99 differences, 78 systolic (SBP) and 84 diastolic (DBP) differences were within 5 mmHg; all differences were within 10 and 15 mmHg for both SBP and DBP. In phase 2.2 for SBP and DBP, respectively, 28 of 33 and 31 of 33 participants had at least two out of their three differences within 5 mmHg. Only one participant was found to have all three differences greater than 5 mmHg for SBP and DBP, respectively. The device also fulfilled the criteria of the Association for the Advancement of Medical Instrumentation standard with a mean difference+/-SD of -2.5+/-3.4 mmHg (SBP) and -2.3+/-3.6 mmHg (DBP). The Rossmax Mandaus II is the first auscultatory device with a numeric digital display to pass the ESH protocol. It can be recommended for clinical use in an adult population.