Medset Scanlight-III
Device Name:
Scanlight-III
Manufacturer:

OBL: Medset Medizintechnik GmbH, Curslacker Neuer Deich 66, D-21029 Hamburg, GERMANY.

OEM: Industrielle Entwicklung Medizintechnik und Vertriebsgesellschaft GmbH (IEM), Cockerillstraße 69, D-52222 Stolberg, 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 Specifications:
Click here to download the Device Specifications
Description:
The Medset Scanlight-III 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:
While the technology used in the Medset Scanlight-III, to measure blood pressure, has been declared as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared 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 BIHS (UK and IRL) ABPM Manufacturer declaration of equivalence to the IEM Mobil-O-Graph NG
BP ESH (Europe) ABPM The BIHS recommendation, despite the absence, at the time, of the scientific evidence required by the same authors' criteria.
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 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

IEM Mobil-O-Graph PWA

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)

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