The Mindray BeneVision N12 is a patient monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements and information regarding the accuracy of its oxygen saturation measurement technology does not appear to be available. Both upper arm and intra-arterial measurements can be taken and oxygen saturation measurements are taken from the finger. It is intended for bedside patient monitoring.

While the technology used in the Mindray BeneVision N12, to measure blood pressure, has been declared as being equivalent to that used in another device, not only has no evidence has been published to show that the devices have been compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4, but the results of the assessment on which the declaration has been based have not been published either and cannot be verified. However, there are validation studies proving clinical validation of the same measurement technology, according to other equivalence claims. There appears to be no peer-reviewed clinical validation information available on the technology used in the Mindray BeneVision N12 to measure peripheral oxygen saturation.

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	None	Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP	BIHS (UK and IRL)	Hospital use	Manufacturer declaration of equivalence to a device without published evidence