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IEM Mobil-O-Graph PWA
Device Name:
Mobil-O-Graph PWA
Manufacturer:
Industrielle Entwicklung Medizintechnik und Vertriebsgesellschaft GmbH (IEM), Cockerillstraße 69, D-52222 Stolberg, GERMANY.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for ABPM with central aortic pressure
Measurement Site:
Upper Arm
Measurement Occurrence:
Intermittent measurements at specified intervals or times
Availability:
Available Currently
Availability according to Countries or Regions:
Germany, Ireland and United States
Device Manual:
Click here to download the Device Manual
Description:
The IEM Mobil-O-Graph PWA 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 ABPM, along with central aortic pressure.
Assessment:
The technology used in the IEM Mobil-O-Graph PWA, to measure blood pressure, has been assessed, in a specific population, according to a non-standard protocol. It also appears to be very similar to another device by the same 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 AssessmentRecommendationBasis
BP Medaval None Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP Stride BP ABPM for adults Published evidence
BP AMA VDL (US) ABPM Published evidence
Device Family:
Cardioline Walk200bB, IEM Mobil-O-Graph NGB, IEM Mobil-O-Graph PWAZ, Medset Scanlight-IIIB, Hillrom ABPM 7100B
Legend: B BIHS Derivative, Z Almost Certain
Validation Publications:

Shiraishi M, Murakami T, Higashi K. The accuracy of central blood pressure obtained by oscillometric noninvasive method using Mobil-O-Graph in children and adolescents. J Hypertens. 2020 May;38(5):813-820. doi: 10.1097/HJH.0000000000002360. PMID: 31990901.

Ad Hoc protocol - Pass Children, aged 1 to 11 years (n=49); Adolescents, aged 12 to 18 years (n=11) (Note: Central BP validation)

Mynard JP, Goldsmith G, Springall G, Eastaugh L, Lane GK, Zannino D, Smolich JJ, Avolio A, Cheung MMH. Central aortic blood pressure estimation in children and adolescents: results of the KidCoreBP study. J Hypertens. 2020 May;38(5):821-828. doi: 10.1097/HJH.0000000000002338. PMID: 31790068.

IA protocol - Fail Children and adolescents, aged 3 to 18 years (n=52) (Note: Central BP validation with brachial SBP and DBP calibration; Failed for SBP)

IA protocol - Fail Children and adolescents, aged 3 to 18 years (n=52) (Note: Central BP validation with brachial MAP and DBP calibration; Failed for SBP)

Relevant Publications:

Sarganas G, Kuhnert R, Gohlisch C, van der Giet M, Neuhauser H. Comparison of two blood pressure oscillometric devices: Datascope Accutorr Plus and Mobil-O-Graph PWA and conversion of blood pressure values from one device to the other. Blood Press Monit. 2020 Feb;25(1):42-49. Epub: 2019 Oct 15. doi: 10.1097/MBP.0000000000000409. PMID: 31633519.

Measurements from the IEM Mobil-O-Graph PWA are compared to those from the Datascope Accutorr Plus, though not in a formal validation.

Díaz A, Bia D, Zócalo Y. Impact of Methodological and Calibration Approach on the Association of Central and Peripheral Systolic Blood Pressure with Cardiac Structure and Function in Children, Adolescents and Adults. High Blood Press Cardiovasc Prev.. 2019 Dec;26(6):509-534. Epub: 2019 Oct 30. doi: 10.1007/s40292-019-00346-0. PMID: 31667753.

Nine estimates of SBP, four Mobil-O-Graph [1) Peripheral, 2) Central by brachial SBP and DBP calibration, 3) Central by brachial MAP and DBP calibration, 4) Central by calculated MAP and brachial DBP calibration], two Tensiomed Arteriograph [5) Peripheral, 6) Central by auto-calibration] and three by aortic root ultrasound images with diameter waveform recalibration based on [7) Mobil-O-Graph brachial MAP and DBP, 8) Mobil-O-Graph calculated MAP and brachial DBP, 9) Arteriograph calculated MAP and brachial DBP] were compared.

Mynard JP, Sharman JE, Smolich JJ, Cheung MMH, Avolio A. Accuracy of central blood pressure by Mobil-O-Graph in children and adolescents. J Hypertens. 2020 Jul;38(7):1388-1389. doi: 10.1097/HJH.0000000000002466. PMID: 32502100.

Commenatry on Shiraishi (2020) and Mynard (2020) results.

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.

IEM Mobil-O-Graph NG

Franssen PM, Imholz BP. Evaluation of the Mobil-O-Graph new generation ABPM device using the ESH criteria. Blood Press Monit. 2010 Aug;15(4):229-31. PMID: 20658764.

ESH-IP:2002 - Pass General population

Weiß W, Tölle M, Zidek W, van der Giet M. Validation of the mobil-O-Graph: 24 h-blood pressure measurement device. Blood Press Monit. 2010 Aug;15(4):225-8. doi: 10.1097/MBP.0b013e328338892f. PMID: 20216407.

BHS:1993 - Pass General population

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