In the field of blood pressure monitoring, accuracy is widely regarded as a fundamental requirement. With changes in lifestyle, the proportion of people with larger arm circumferences (>40cm) has risen significantly. To meet the growing health monitoring needs of this population, ensuring the precision of monitoring devices is crucial for both home health management and clinical diagnosis. Recently, a study strictly following the AAMI/ESH/ISO universal standards (ISO 81060-2:2018 Amd 1:2020) as well as the standards that are recognized by the U.S. FDA has provided clinical validation data for Joytech's DBP-6286B arm-type fully automatic digital blood pressure monitor.
At the First Hospital of Hebei Medical University and the Inner Mongolia Autonomous Region People’s Hospital, the study included 85 eligible participants. Through a rigorous comparison analysis of more than 255 sets of data, comparing the measurements of the DBP-6286B with the reference device (mercury sphygmomanometer), the results showed:
The mean difference between the test device (DBP-6286B) and the reference device met the accuracy criteria, demonstrating compliance with the international standards of the AAM/ESH/ISO and the widely accepted consensus standards recognized by the U.S. FDA.
This study, which included a diverse participant pool in terms of age, gender, arm circumference, and blood pressure levels, supports the device’s consistent performance across a varied user base.
Professional functionality, creating a reliable health partner
The validated accuracy of the Joytech DBP-6286B is supported by design features aimed at enhancing measurement reliability for all users, including those with larger arm circumferences.
Specially designed preformed cuff that can maintain even pressure distribution across the range of arm circumferences;
An advanced oscillometric algorithm is used to compensate for signal attenuation in obese subjects.
Moreover, this device is equipped with multiple practical features such as irregular heartbeat detection, arm shake and cuff loose indicators, and WHO classification indicators. At the same time, its voice broadcast, backlight display, and Bluetooth transmission functions make long-term health monitoring much easier. These features, combined with its validated accuracy, make the DBP-6286B a comprehensive tool for long-term health tracking, aiming to support the partners in delivering added value to their end-users.
Respond to measurement gaps and highlight R&D strengths
The success of this validation has a dual significance.
First of all, it directly responds to the rapidly growing demand in the global health market. With changing lifestyles, the proportion of people with larger arm circumferences has increased significantly, yet dedicated, validated devices for this group remain relatively scarce. Joytech's latest validation precisely tackles this measurement challenge in the niche market with advanced technology, offering every partner professional, value-driven partnerships.
Secondly, demonstrating compliance with multiple internationally recognized standards, including AAMI, ESH, ISO, and FDA is an evidence of technical capability of the company's technological reliability and quality system. It proves to global partners that Joytech products not only have innovative features, but their core measurement performance is also based on clinical validation.
In conclusion
As a high-tech enterprise focused on the field of medical health monitoring, Joytech has always placed accuracy, reliability, and innovation as its top priorities. The clinical validation of the DBP-6286B is another example of putting this commitment into practice. We are dedicated to continuously innovating our technology to provide truly trustworthy health products to partners worldwide.
For more technical details or validation information, please feel free to contact us. Let us work together to bring the promise of precision and health to more families around the world.
