GE Tonoport V

Device Name:

Tonoport V

Manufacturer:

OBL: General Electric Company, 33-41 Farnsworth Street, Boston, MA 02210, UNITED STATES.

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:

Click here to download the Device Manual

Description:

The GE 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 GE 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.
BP	BIHS (UK and IRL)	ABPM	Published evidence
BP	ESH (Europe)	ABPM	Published evidence
BP	Stride BP	ABPM for adults	Published evidence

Device Family:

GE Tonoport VZ, Marquette Tonoport VZ, PAR Tonoport VZ
Legend: Z Almost Certain

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