Device Name:
Vismo PVM-2700 Series
Device Model:
PVM-2703
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, SpO2, PR, ECG, Temperature, Respiration and Arrhythmias
Primary Client Use:
Intended for patient monitoring
Measurement Site:
BP: Upper Arm; SpO2: Finger
Measurement Occurrence:
BP: Single and intermittent measurements; SpO2: Continuous measurement
Availability:
Available Currently
Availability according to Countries or Regions:
Japan
Device Specifications:
Description:
The Nihon-Kohden PVM-2703 is a vital signs 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-2703, 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-2703 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 (2019-2024) |
Implied equivalence to the Nihon Kohden PVM-2701/Impulse-1 |
Device Family:
Nihon-Kohden PVM-2701J,
Nihon-Kohden PVM-2703J,
Nihon-Kohden BSM-1700 (PT)J,
Nihon-Kohden BSM-3500 Series (VS)J,
Nihon-Kohden BSM-6000 Series (TR)J,
Nihon-Kohden CSM-1500 Series (G5)J,
Nihon-Kohden CSM-1700 Series (G7)J,
Nihon-Kohden CSM-1900 Series (G9)J,
Nihon-Kohden BSM-3700 Series (VS)J,
Nihon-Kohden TEC-8300 SeriesJ,
Nihon-Kohden ZM-540J,
Nihon-Kohden ZM-940PGJ,
Nihon-Kohden GZ-140PJ,
Nihon-Kohden PVM-9900J,
Nihon-Kohden RMC-5000J,
Nihon-Kohden SVM-7000 SeriesJ,
Nihon-Kohden TEC-5600 SeriesJ,
Nihon-Kohden ZS-640J,
Nihon-Kohden ZS-940PJ,
Nihon-Kohden PVM-4000J,
Nihon-Kohden EMS-1052J,
Nihon-Kohden BSM-5700 Series (E7)J,
Nihon-Kohden TEC-1000 SeriesJLegend:
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 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)
