Device Dossier
Sphygmomanometer, electronic, automatic
Device Dossier for Sphygmomanometer, electronic, automatic (Automatic-inflation electronic sphygmomanometer, non-portable, Class IIa, sponsor Uscom).…
Intended purpose
BP+ is a non-invasive, compact standalone measurement device that automatically measures systolic and diastolic pressure, and pulse rate in adult and paediatric patients. BP+ also provides non-invasive central (aortic) systolic and diastolic blood pressure, augmentation index, pulse waveform and other parameters intended for use in adult patients. BP+ performs measurements using a conventional oscillometric method via a brachial cuff on the upper arm. The device is intended to be used under supervision by qualified healthcare personnel. The device is not intended for operating theatre, intensive care, or continuous patient monitoring use.