Device Name:
Tonoport V
Manufacturer:
OBL: Marquette Hellige GmbH (GE), Postfach 600265, D-79032 Freiburg, GERMANY.
OEM: PAR Medizintechnik GmbH & Co. KG, Platinum, Sachsendamm 6, 10829 Berlin, GERMANY.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for ambulatory blood pressure monitoring
Measurement Site:
Upper Arm
Measurement Occurrence:
Intermittent measurements at specified intervals or times
Availability:
Available Currently
Device Manual:
Description:
The Marquette Tonoport V is an ambulatory blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the upper arm. It is intended for ambulatory blood pressure monitoring.
Assessment:
There appears to be no peer-reviewed clinical validation information available on the technology used in the Marquette Tonoport V to measure blood pressure. However, this device appears to be very similar to a validated device by the same (OEM) manufacturer or a device within a family of equivalent devices, but equivalence needs to be proven according to a protocol compliant 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. |
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.
PAR Tonoport V
O'Brien E, Atkins N, Murphy A, Lyons S. Validation of the TONOPORT V ambulatory blood pressure monitor according to the European Society of Hypertension International Protocol for Validation of Blood Pressure Measuring Devices in Adults. Blood Press Monit. 2003 Dec;8(6):255-60. PMID: 14688556.
ESH-IP:2002 - Fail General population
Haensel A, Utech K, Langewitz W. Validation of TONOPORT V blood-pressure measuring monitor in adults. J Hum Hypertens. 2005 Sep;19(9):745-9. PMID: 15951741.
ESH-IP:2002 - Pass General population
