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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
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 but equivalence needs to be proven according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
BIHS (UK and IRL)ABPMPublished evidence
ESH (Europe)ABPMPublished evidence
Stride BPABPM for adultsPublished evidence

Device Family:GE Tonoport VZ, Marquette Tonoport VZ, PAR Tonoport VZ (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