Welch Allyn ABPM 6100
While the technology used in the Welch Allyn ABPM 6100, 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.
| Accuracy Assessment | Recommendation | Basis | ||
|---|---|---|---|---|
| Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. | ||
| BIHS (UK and IRL) | ABPM | Manufacturer declaration of equivalence | ||
| ESH (Europe) | ABPM | The BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria. | ||
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.
Suntech Oscar 2
Jones SC, Bilous M, Winship S, Finn P, Goodwin J. Validation of the OSCAR 2 oscillometric 24-hour ambulatory blood pressure monitor according to the International Protocol for the validation of blood pressure measuring devices. Blood Press Monit. 2004 Aug;9(4):219-23. PMID: 15311149.
ESH-IP:2002 - Pass General population
Goodwin J, Bilous M, Winship S, Finn P, Jones SC. Validation of the Oscar 2 oscillometric 24-h ambulatory blood pressure monitor according to the British Hypertension Society protocol. Blood Press Monit. 2007 Apr;12(2):113-7. PMID: 17353655.
ESH-IP:2002 - Pass General population
