Product

Medical

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
- Professional BPM -
Model Authors Article Published on Protocol Result
TM-2430 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
Yip GW, So HK, Li AM, Tomlinson B, Wong SN, Sung RY. Validation of the 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 TM-2655P Zhanna D. Kobalava, Yulia V. Kotovskaya, Lala A. Babaeva and Valentin S. Moiseev. Validation of the TM-2655 oscillometric device for blood pressure measurement. Blood Pressure Monitoring, 2006, 11:87-90 BHS A/A
UM-101 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
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
TM-2656 TM-2656 Wei-Fang Zeng, Ming Liu, Yuan-Yuan Kang, Yan Li and Ji-Guang Wang Validation of the fully automated A&D TM-2656 blood pressure monitor according to the British Hypertension Society Protocol Blood Pressure Monitoring,2013,18:223-226 BHS A/A
- Home Use BPM -
Model Authors Article Published on Protocol Result
UA-767 UA-767 Rogoza AN, Pavlova TS, Sergeeva MV. Validation of the 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 UA-767Plus Kobalava ZD, Kotovskaia LV, Rusakova OS, Babaeva LA. Validation of the 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)
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 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 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 Pressure Monitoring. 2002, 7:243-248 ESH Pass
UA-85X UA-85X Bonso E, Ragazzo F, Palatini P. Validation of the 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 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 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 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
UA-1020 (UA-1010/1020/1030T) UA-1020 Wei-Fang Zeng, Yuan-Yuan Kang, Ming Liu, Yan Li and Ji-Guang Wang Validation of the A&D UA-1020 upper-arm blood pressure monitor for home blood pressure monitoring according to the British Hypertension Society Protoco Blood Pressure Monitoring, 2013,18:177-181, 272-277 BHS A/A
UB-542 UB-542 Francesca Saladini, Elisabetta Benetti, Claudio Fania and Paolo Palatini Validation of the A&D BP UB-542 wrist device for home blood pressure measurement according to the European Society of Hypertension International Protocol revision 2010 Blood Pressure Monitoring, 2013,18:219-222 ESH Pass
UA-651 UA-651 Elisabetta Benetti, Claudio Fania and Paolo Palatini Validation of the A&D BP UA-651 device for home blood pressure measurement according to the European Society of Hypertension International Protocol revision 2010. Blood Pressure Monitoring, 2014,19:50-53 ESH Pass
UA-651
(Wide range cuff )
UA-651 Elisabetta Benetti, Claudio Fania and Paolo Palatini Validation of the A&D BP UA-651 device with a wide-range cuff for home blood pressure measurement according to the European Society of Hypertension International Protocol revision 2010. Blood Pressure Monitoring, 2015, 20:164-167 ESH Pass
UB-543 UA-651 Claudio Fania, Elisabetta Benetti and Paolo Palatini Validation of the A&D BP UB-543 wrist device for home blood pressure measurement according to the European Society of Hypertension International Protocol revision 2010. Blood Pressure Monitoring, 2015, 20(4):237-240 ESH Pass

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