The BIOS BD353 (Precision 12.0 - Protocol 7D MII) is an automatic blood pressure monitor. Medaval has not found evidence proving the accuracy of its blood pressure measurement technology. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.

While the technology used in the BIOS BD353 (Precision 12.0 - Protocol 7D MII), 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 there is no evidence provided on a validation of the other device.

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	Not recommended	This device has not been shown to have been clinically validated.
BP	Hypertension Canada	Self-measurement (Silver)	Manufacturer declaration of equivalence