Codemes

Clinical Validation

It is of great importance to have products evaluated and validated in accordance with protocols set by organizations such as the British Hypertension Society (BHS), the Association for the Advancement of Medical Instrumentation (AAMI) and, the Working Group on Blood Pressure Monitoring of the European Society of Hypertension (ESH). The protocols of these organizations have become highly regarded standards. In the US, our products meet FDA requirements, facility audits, and regulatory pathways via the 510(k) process.

In light of the fact that our Blood Pressure Monitors are to be absolutely dependable, many of our blood pressure devices have been validated early in their life cycle. It has become imperative to have the Ambulatory Blood Pressure Monitors (ABPM) evaluated by physicians to verify their accuracy for use in the clinical setting. . Our ABPM has gone through a considerable number of evaluations by prominent physicians to further advance accuracy and reliability. The TM-2420 (ABPM) became the standard of its day, while the newer and current version, the TM-2430, has become the new standard.

In recent years, physicians have come to see the value of monitoring blood pressure at home to compliment treatment of their hypertensive patients. They regard devices for home use accurate enough to support their patients continuing care. Consequently, the demand for device validation of personal monitors has increased. At A&D, as leaders in blood pressure technology we are confident in the accuracy of our devices and the ability to be able to fulfill the strict requirements of healthcare professionals. All of our blood pressure monitors are validated independently in order that they comply with varying governmental regulations.

A majority of our monitors have also been validated by leading professionals. UA-767 and UA-767 Plus were validated and published in accordance with the BHS protocol. Others like UA-631/779 or UA-787 were validated under the new ESH protocol. Both have received notoriety for their publications in the professional journals like Blood Pressure Monitoring.

These examples demonstrate the performance of our products. Others studies are under development, which shall subject our devices to stringent testing and evaluation in order to create products that professionals can use with confidence.

The list of our monitors validated under world-class protocols

Model	Authors	Article	Published on	Protocol	Result
UA-767	Rogoza AN, Pavlova TS, Sergeeva MV.	Validation of A&D UA-767 device for the self-measurement of blood pressure.	Blood Pressure Monitoring, 2000, 5:227-231	BHS	A/A
UA-767 Plus	Kobalava ZD, Kotovskaia LV, Rusakova OS, Babaeva LA.	Validation of UA-767 Plus device for self-measurment of blood pressure.	Clinical Pharmacology and Therapy, 2003, 12 (2)	BHS	A/A
UA-774 (UA-767 Plus)	Verdecchia P, Angeli F, Poeta F, Reboldi GP, Borgioni C, Pittavini L, Porcellat C.	Validation of the A&D UA-774 (UA-767Plus) device for self-measurement of blood pressure.	Blood Pressure Monitoring, 2004, 9:225–229	BHS	A/A
UA-787	Longo D, Toffanin G, Garbelotto R, Zaetta V, Businaro L, Palatini P.	Performance of the UA-787 oscillometric blood pressure monitor accoarding to the European Society of Hypertension protocol.	Blood Pressure Monitoring, 2003, 8: 91-95	ESH	Pass
UA-779/631	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 Pressure Monitoring. 2002, 7:243-248	ESH	Pass
UA-85x	Bonso E, Ragazzo F, Palatini P.	Validation of A&D UA-85x (UA-851, 852, 853, 854, 855) device for blood pressure measurement.	Blood Pressure Monitoring. 2008, 13:339-341	ESH	Pass
UA-704	Zhanna D. Kobalava, Yulia V. Kotovskaya and Eugeniy Rodionov.	Validation of semi-automatic device UA-704 for self-measurement of blood pressure.	Blood Pressure Monitoring, 2005, 10:223-225	BHS	A/A
UA-705	Verdecchia P, Angeli F, Gattobigio R, Angeli E, Pede S, Pittavini L.	Validation of the A&D UA-705 device for self-measurement of blood pressure according to the British Hypertension Society protocol.	Blood Pressure Monitoring, 2006, 11:223-227	BHS	A/A
UB-511/512	Angeli F, Sardone M, Angeli E, Repaci S, Gattobigio R, Verdecchia P.	Validation of the A&D wrist-cuff UB-511 (UB-512) device for self-measurement of blood pressure.	Blood Pressure Monitoring, 2006, 11:349-354	BHS	B/B
TM-2430	Palatini P, Frigo G, Bertolo O, Roman E, Da Cortà R, Winnicki M.	Validation of the A&D TM-2430 device for ambulatory blood pressure monitoring and evaluation of performance according to subjects' characteristics.	Blood Pressure Monitoring, 1998, 3: 255-260	BHS	A/A
TM-2430	Yip GW, So HK, Li AM, Tomlinson B, Wong SN, Sung RY.	Validation of A&D TM-2430 upper-arm blood pressure monitor for ambulatory blood pressure monitoring in children and adolescents, according to the British Hypertension Society protocol.	Blood Pressure Monitoring, 2012, 17:76-9	BHS	A/B
TM-2655P	Zhanna D. Kobalava, Yulia V. Kotovskaya, Lala A. Babaeva and Valentin S. Moiseev.	Validation of TM-2655 oscillometric device for blood pressure measurement.	Blood Pressure Monitoring, 2006, 11:87-90	BHS	A/A
TM-2564GP	Zhanna D. Kobalava, Yulia V. Kotovskaya, Eugeniy Rodionov and Valentin S. Moiseev.	Validation of the TM-2564G device for in-hospital blood pressure measurement	Blood Pressure Monitoring, 2005, 10:333-335	BHS	A/A
UM-101	Stergiou GS, Giovas PP, Gkinos CP, Tzamouranis DG.	Validation of the A&D UM-101 professional hybrid device for office blood pressure measurement according to the International Protocol	Blood Pressure Monitoring, 2008, 13:37-42	ESH	Pass
UM-101	Pruijm MT, Wuerzner G, Glatz N, Alwan H, Ponte B, Ackermann D, Burnier M, Bochud M.	A new technique for simultaneous validation of two manual nonmercury auscultatory sphygmomanometers (A&D UM-101 and Accoson Greenlight 300) based on the International protocol.	Blood Pressure Monitoring, 2010, 15:322-5	ESH	Pass