Nihon-Kohden PVM-4000

Description:

The Nihon-Kohden PVM-4000 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. Blood pressure measurements are taken from the upper arm and oxygen saturation measurements are taken from the finger. It is intended for bedside patient monitoring.

Assessment:

The technology used in the Nihon-Kohden PVM-4000, to measure blood pressure, has been compared to a clinically validated device, but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4. There appears to be no peer-reviewed clinical validation information available on the technology used in the Nihon-Kohden PVM-4000 to measure peripheral oxygen saturation.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	None	Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP	Japanese Society of Hypertension	Professional use (2021-2024)	Implied equivalence to the Nihon Kohden PVM-2701/Impulse-1

Device Family:

Validation Publications for Equivalent Devices:

Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.

Nihon-Kohden PVM-2701

Alpert BS. Validation of the Nihon Kohden PVM-2701/Impulse-1 automated device by both AAMI (2002) and ISO standards testing. Blood Press Monit. 2012 Oct;17(5):207-9. doi: 10.1097/MBP.0b013e328359c48e. PMID: 22968109.

81060-2:2009 - Pass Adults (n=69) and children (n=41)

SP10:2002 - Pass Adults (n=69) and children (n=41)