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 510K 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 international protocols
Model Authors Article Published on Protocol Result
TM-2430 Palatini P, Frigo G, Bertolo O et al. 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
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-779/631 Daniele Longo, Olivo Bertolo, Gianluca Toffanin, Paola Frezza and Paolo Palatini 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 Passed all 3 phases
UA-787 Danile Longo, Gianluca Toffanin, Raffaella Garbelotto, Vania Zaetta, Lucio Businaro and Paolo Palatini 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 Passed all 3 phases
UA-767 Plus Zhanna D. Kobalava, Loulia V. Kotovskaia, Olga S. rusakova, Lala A. Babaeva 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) Drs. Paolo Verdecchia, Fabio Angeli, Fabrizio Poeta, Gian Paolo Reboldi, Claudia Borgioni, Loretta Pittavini and Carlo Porcellat 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-704 Zhanna D. Kobalava, Yulia V. Kotovskaya and Eugeniy Rodionov Validation of semi-automatic device UA-704 for self-measurement of blood pressure. BloodPressure Monitoring 2005, 10:223-225 BHS A/A
TM-2564G 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
TM-2655 Zhanna D. Kobalava, Yulia V. Kotovskaya, Lala A. Babaeva and Valentin S. Moiseev Validation of the TM-2655 device for blood pressure measurement Blood Pressure Monitoring 2006, 11:87-90 BHS A/A

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