Preliminary study on key technologies and quality control of wearable medical equipment

In recent years, with the acceleration of the aging process of the population, many chronic diseases have become younger in the population, and people's health requirements and health awareness are increasing day by day. All of this directly or indirectly promotes the shift of medical care from symptomatic treatment to Mode change of prevention, early diagnosis and early treatment. The development of medical devices has also shifted from complex, large-scale equipment used in medical institutions to small wearable or even sheet-like implants that can be adapted to hospitals and to meet the needs of families and individuals. In addition, certain special industries and fields, such as deep water operations, athlete training and aerospace, also have urgent and extensive use requirements for wearable medical devices. In order to meet the needs of the masses and related industries, many research institutions and enterprises at home and abroad are increasing their research and development efforts and investment in wearable medical equipment, and have accumulated certain experience and research results. With the proliferation of "star effects" such as Google glass, Jawbone up, Fitbit flex and Galaxy gear (Figure 1), Wearables became famous in 2013 and became one of the most noteworthy industries in 2014.

Preliminary study on key technologies and quality control of wearable medical equipment

Figure 1 Various wearable devices

Fig.1 Various wearable devices

Wearable medical devices will bring a revolutionary revolution in the medical device industry (miniature-portable-wearable), not only to monitor blood pressure, blood sugar, heart rate, body temperature, blood oxygen content, respiratory rate, etc., anytime, anywhere. Health indicators can also be used for the treatment of a variety of diseases, such as iontophoresis patches can treat headaches, smart glasses help people with Alzheimer's disease to arouse people and things that are easy to forget, Google glass can broadcast live surgery Wait. At present, wearable medical equipment is mainly used for continuous monitoring of physiological parameters. It is especially important for mastering the overall physical condition of many patients with chronic diseases such as diabetes, cardiovascular disease, respiratory diseases and hypertension. Blood sugar, blood pressure, blood oxygen, The accuracy of the heart rate is critical to improving the condition and maintaining life safety. At present, the supervision and management of wearable medical equipment is basically blank. Because it is frequently used during the wearing process, it is often subjected to various shocks, frictions, and knocks, causing it to be worn, deformed, etc., and its magnitude will change, thus losing Accuracy, resulting in out-of-tolerance. According to iiMedia Research data, the market size of China's wearable medical equipment market in 2012 was 420 million yuan. It is estimated that this market will reach 1.2 billion yuan by 2015, and will reach 4.77 billion yuan in 2017, with a compound annual growth rate of 60%. The expansion of scale has brought huge measurement and testing needs, and it is urgent to carry out research on its related measurement and test methods, develop verification devices suitable for wearable medical equipment, and formulate its industry standards and verification procedures/calibration specifications to ensure its magnitude. Accurate and consistent, correct and reliable.

1 Overview of wearable medical devices

Wearable Medical Devices can integrate vital sign signal detection technology into everyday wearable jewelry and clothing. It has convenient operation, continuous uninterrupted work, intelligent display monitoring results, abnormal physiological signal alarm and wireless data transmission. It is widely used in chronic disease monitoring, special population monitoring, emergency treatment, comprehensive family diagnosis, and sleep quality analysis. The research directions currently involved include: body adaptability research, biomedical sensor design, multi-sensor data fusion, system optimization, body sensing network development, battery life extension, wireless

Real-time transmission and system security and reliability improvements. At present, the carriers of wearable medical devices can be roughly divided into two categories: one is a personal belongings such as a ring, a wristwatch, and a glove; the other is an e-textile, and the former has the advantage of being easy to move and operate. Portable, the latter is the ability to simultaneously monitor multiple types of vital signs. Combining the two forms a complete set of wearable medical devices.

2 Key technologies for wearable medical devices

Wearable devices are primarily monitored by a variety of biomedical sensors and are classified into motion sensors, biosensors, and environmental sensors. Biomedical sensors are components or modular devices that convert various vital sign signals into electrophysiological signals available for medical instruments (electric signals are more suitable for transmission, conversion, processing, and quantitative operations), primarily by sensitive devices, electronics, and conversion. Expanded device composition, piezoelectric sensors are widely used in sensitive devices. Piezoelectric sensor is an active device that can output positive and positive electrical signals under mechanical excitation. It can be used to design the acceleration of piezoelectric stethoscope, blood pressure sensor, fetal heart sound, microphone and micro-tremor. Count.

2.1 physiological parameters non-invasive continuous monitoring technology

Wearable medical devices can collect human electrophysiological data (such as blood sugar, blood pressure, heart rate, blood oxygen content, body temperature, respiratory rate, etc.) through biomedical sensors, and wirelessly transmit monitoring data to a central processor (such as small handheld wireless) The device can issue a warning when the physiological signal is abnormal. The central processor then sends the data to each medical center for professional, timely and comprehensive analysis and treatment.

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