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Hillrom ABPM 7100
Device Model:
ABPM 7100
Manufacturer:

OBL: Hill-Rom Holdings Inc., Suite 1000, 130 East Randolph Street, Chicago, IL 60601, UNITED STATES.

OEM: Industrielle Entwicklung Medizintechnik und Vertriebsgesellschaft GmbH (IEM), Cockerillstraße 69, D-52222 Stolberg, GERMANY.

Former: Welch Allyn Inc., 4341 State Street Road, Skaneateles Falls, NY 13153, UNITED STATES.

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
Availability according to Countries or Regions:
Ireland
Device Manual:
Description:
The Hillrom ABPM 7100 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 Hillrom ABPM 7100, 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
BP ESH (Europe) ABPM The BIHS recommendation, despite the absence, at the time, of the scientific evidence required by the same authors' criteria.
BP FDA (US) 510(k) 510(k) K021756
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