Validation of a non-mercury digital auscultatory device with manual pressure registration (PMS Mandaus).
OBJECTIVE
To assess the clinical accuracy of a non-mercury digital auscultatory device (PMS Mandaus) with manual pressure registration in an adult population.


METHODS
The accuracy of the device was assessed by predefined criteria (European Society of Hypertension protocol) in 33 study participants recruited from among patients and staff in a teaching hospital. A series of same-arm sequential blood pressure measurements were taken: first, two observers taking simultaneous mercury readings, followed by a reading with the device. A total of seven readings were taken from each participant in the sitting position. The data were then analysed according to the European Society of Hypertension protocol and the criteria of the Association for the Advancement of Medical Instrumentation.


RESULTS
The device fulfilled the criteria of the European Society of Hypertension protocol, achieving a pass for both systolic and diastolic pressure. The device also passed the Association for the Advancement of Medical Instrumentation standard (the mean to be within 5+/-8 mmHg) with the mean differences being -3.2+/-3.8 mmHg for systolic blood pressure and -1.8+/-2.9 mmHg for diastolic blood pressure.


CONCLUSIONS
The device performed in a satisfactory manner according to the European Society of Hypertension and the Association for the Advancement of Medical Instrumentation criteria. The systematic under-recording related to the delay of manual pressure registration is not sufficient to preclude clinical use.
Wilton
Anja
A
Kings College London, Guy's, Kings and St Thomas' School of Medicine, Maternal and Fetal Health Research Unit, Division of Reproductive Health, Endocrinology and Development, St Thomas' Hospital, London, UK.
Shabeeh
Husain
H
Cuckson
Clare
C
Shennan
Andrew H
AH
D000328:Adult; D000368:Aged; D001795:Blood Pressure Determination / Q000295:instrumentation*; D005260:Female; D006801:Humans; D006973:Hypertension / Q000175:diagnosis; D008297:Male; D008875:Middle Aged