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 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	Manufacturer declaration of equivalence to the IEM Mobil-O-Graph
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, Medset Scanlight-IIIB, Hillrom ABPM 7100B
Legend: B BIHS Derivative

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