Hingmed Medical obtained the registration certificate of 24-hour ambulatory blood pressure monitor
After nearly two years of unremitting efforts, Hingmed Medical ABP-03 and ABP-03A ambulatory blood pressure monitors have obtained the registration certificate issued by the Food and Drug Administration.
Hingmed Medical has the mission of "providing advanced blood pressure monitoring technology and products so that people can more accurately understand their own blood pressure and health". At the beginning of the company's establishment, it aimed at the international advanced level, hoping that the ABP-03(A) model products would become The leading domestic and international excellent ambulatory blood pressure meter brand.
The entire registration process has gone through the review of the Shenzhen Food and Drug Administration's production license, the multi-year test of the product conducted by the Medical Device Testing Institute for up to three months, the clinical verification in the hospital, and the medical treatment of the Guangdong Provincial Food and Drug Administration. For the device system audit, the Guangdong Food and Drug Administration conducted a multi-year audit of the product itself for up to three months. Throughout the process, professional institutions have repeatedly verified, tested, and verified that the products' reliability, accuracy, consistency, and other properties have reached first-class level.
Compared with the current brands of ambulatory blood pressure monitors in the domestic market, mainly European and American brands, Xingmai ABP-03A has a distinctive feature that it meets the regulations of China National Food and Drug Administration YY0667 (Europe and the United States also have the same content regulations ). An important item of this regulation is that the ambulatory blood pressure monitor with continuous automatic measurement function must meet the key components, such as the pressure sensor, the master control clock, and the like, with dual protection functions under a single fault. Due to historical reasons, most of the ambulatory blood pressure meters currently on the market do not meet this point. For patients without self-care capabilities, ambulatory blood pressure meters that do not meet this point are dangerous and may damage the patient's upper arm muscles.
In addition, Xingmai ABP-03A dynamic blood pressure monitor also has the following advantages:
1. Clinical grade, accurate measurement. The blood pressure technology with independent intellectual property rights can meet the needs of clinical blood pressure testing even when the patient's pulse is weak.
2. Strong anti-interference ability, good measurement consistency under dynamic environment. It can accurately measure blood pressure within 24 hours of normal life (except vigorous exercise) without affecting daily life and work.
3. Posture record, the doctor can grasp the posture during measurement to help diagnosis. ABP-03(A) can record the posture of the patient's blood pressure measurement and record, there are four states of meditation (standing), lying down, light exercise, vigorous exercise.
4. Warning function for reading over standard. ABP-03 (A) is actually a blood pressure monitor with alarm function. For patients with geriatrics and nephropathy dialysis, this function is of great significance.
5.ABP-03(A) system software is currently the only software in the world that can provide professional blood pressure analysis of blood pressure morning peak index, smoothness index, coefficient of variation, arteriosclerosis index, etc., which is very helpful for doctors in clinical research.
6. Bluetooth wireless data transmission function. ABP-03A adds data wireless transmission function on the basis of ABP-03. This function allows the blood pressure data in the monitor to be wirelessly transmitted to the computer of the medical staff from time to time.
7. ABP-03(A) Xingmai ambulatory blood pressure monitor also has other important advantages. With its excellent performance, stable quality, and good service, the introduction of this product will inevitably have a significant impact on the existing ambulatory blood pressure monitor market.