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Nihon-Kohden CSM-1500
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 AssessmentRecommendationBasis
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:
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)