A&D UA-767BT
While the technology used in the A&D UA-767BT, to measure blood pressure, has been declared as being equivalent to that used in another device, not only has no evidence has been published to show that the devices were compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4 but there is no evidence provided on a validation of the other device.
| 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) | Self-measurement | Manufacturer declaration of equivalence | ||
| ESH (Europe) | Self-measurement | 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.
A&D UA-767
Rogoza AN, Pavlova TS, Sergeeva MV. Validation of A&D UA-767 device for the self-measurement of blood pressure. Blood Press Monit. 2000 Aug;5(4):227-31. PMID: 11035865.
BHS:1993 - Pass (A/A) General population
SP10:1996 - Pass General population
A&D UA-767 Plus
Кобалава ЖД, Котовская ЮВ, Бабаева ЛА, Русакова ОС. [Kobalava ZD, Kotovskaia IV, Rusakova OS, Babaeva LA.] Валидация электронного полностью автоматического прибора UA-777 (A&D, Япония) для самоконтроля АД. [Validation of UA-767 Plus device for self measurement of blood pressure.] Клиническая фармакология и терапия [Clin Pharmacol Ther]. 2003;12(2):70-2. Available from: andyte.com.
BHS:1993 - Pass (A/A) General population
A&D UA-774
Verdecchia P, Angeli F, Poeta F, Reboldi GP, Borgioni C, Pittavini L, Porcellati C. Validation of the A&D UA-774 (UA-767Plus) device for self-measurement of blood pressure. Blood Press Monit. 2004 Aug;9(4):225-9. PMID: 15311150.
BHS:1993 - Pass (A/A) General population
A&D UA-779
Longo D, Bertolo O, Toffanin G, Frezza P, Palatini P. Validation of the A&D UA-631 (UA-779 Life Source) device for self-measurement of blood pressure and relationship between its performance and large artery compliance. Blood Press Monit. 2002 Aug;7(4):243-8. PMID: 12198341.
ESH-IP:2002 - Pass General population
