Device Model:
CSM-1500
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 CSM-1500 is a patient monitor. Its blood pressure measurement technology has been proven to be accurate. Blood pressure measurements are taken from the finger. It is intended for bedside patient monitoring.
Assessment:
The technology used in the Nihon-Kohden CSM-1500, 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 (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)
