Device Model:
BSM-3000
Manufacturer:
Distributer: Nihon Kohden UK Ltd., Unit 118 Trident Court, 1 Oakcroft Road Chessington, Surrey KT9 1BD, UNITED KINGDOM.
Other: Nihon Kohden Corporation, 1-31-4 Nishiochiai, Shinjuku-ku, Tokyo 161-8560, JAPAN.
Measuring functions:
Blood pressure, Vital Signs
Primary Client Use:
Intended for patient monitoring
Measurement Site:
Finger
Measurement Occurrence:
Continuous measurement
Availability:
Available Currently
Availability according to Countries or Regions:
Japan
Description:
The Nihon-Kohden BSM-3000 is a patient monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the finger. It is intended for bedside patient monitoring.
Assessment:
The technology used in the Nihon-Kohden BSM-3000, 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.
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 (Latest: 2019-2022) |
Implied equivalence to the Nihon-Kohden Vismo PVM-2701 |
Device Family:
Nihon-Kohden Vismo PVM-2701J,
Nihon-Kohden BSM-1700J,
Nihon-Kohden BSM-3000J,
Nihon-Kohden BSM-6000J,
Nihon-Kohden CSM-1500J,
Nihon-Kohden CSM-1700J,
Nihon-Kohden CSM-1900J,
Nihon-Kohden PVM-2700J,
Nihon-Kohden TEC-8000J,
Nihon-Kohden ZM-540PGJ,
Nihon-Kohden ZM-940PGJ,
Nihon-Kohden GZ-140PJ,
Nihon-Kohden PVM-9900J,
Nihon-Kohden RMC-5000J,
Nihon-Kohden SVM-7000J,
Nihon-Kohden TEC-5000J,
Nihon-Kohden ZS-640J,
Nihon-Kohden ZS-940PGJ,
Nihon-Kohden Vismo PVM-4000J,
Nihon-Kohden Cardiolife EMS EMS-1052JLegend:
J JHS Implied Equivalence 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 Vismo 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)
