Guangzhou silver standard trade co., LTD
Contact person: Mr Lai
Phone: 13922125860
Telephone: + 86-20-23830796-23830403
Fax: + 86-20-34637699
Website: www.yichuanghuanwei.com
Email address: laiqiangping2010@163.com
Address: guangzhou panyu district clock villages Zhong Ronglu 1 technology center to A building AS388 # 3 floor
Anesthetic depth monitoring based on eeg signals is a challenging problem, existing products abroad exist algorithm is complex, the price is high, does not apply to China's population more than problems. The design of this product on the algorithm USES the nonlinear dynamics of entropy algorithm, on the complexity than foreign anesthesia monitor using the simple algorithm, high robustness, has the very good pharmacodynamics characteristics. Clinical test and verify the reliability of algorithm of the algorithm and the only American FDA (us food and drug administration) products BIS has good correlation, can satisfy the complex algorithm in the process of anesthesia monitoring. Products used on the front-end amplifier design to realize the TI company TMS320C5416 digital signal processor, digital filter and the algorithm was realized on the slice processing. At the same time, the high-speed AD sampling and digital isolation technology, improve the anti-interference ability. Design the front-end amplifier, separating from the main controller, using a high speed USB transmission method. System of main controller adopts industrial-grade atom motherboard, the embedded Linux operating system, to ensure the reliability of the operation monitoring and real-time performance. System adopts the high reliable storage technology at the same time. Can save more than 500 hours of anesthesia monitoring eeg data. System USES a touch screen technology, convenient for clinical application. The design of this product adopts the advanced algorithm in theory, in the realization of the same application for high-tech computer electronic technology. Products not only for our country in the field of anesthesia monitoring clinical technology provides a good guarantee, to break the blockade in the field of advanced anesthesia monitoring technique. Also achieved breakthrough in the field of applied research of brain electrical signal. The application of the product can also be extended to the guardian of sleep and in-depth understanding of brain function, the product has a broad application value and market potential.
Statistics show that 2005-2007, three years, our hospital procurement of various types of monitor the average annual growth of 10% or more. The secondary and tertiary hospitals become the main monitor growth market, especially the tertiary hospitals purchasing monitor's average annual growth rate is over 50%. Electrical (EEG) monitoring anesthesia is the essential means to accurately monitoring anesthesia, with the increasing exchanges with domestic and foreign medical technology, the medical treatment unit for an objective and quantitative monitoring of anesthetic depth requirements more and more intense, the opportunity of traditional monitoring means such as ECG, heart rate can meet the requirement of medical development. The quality of anesthesia for the operation risk, patients with postoperative recovery has an important value. Based on EEG monitoring is one of the internationally recognized anaesthesia monitoring method, but there are still many challenges, the famous American BIS of anesthesia monitor occupies more than 94% of the world market, and the depth of anesthesia monitoring core technology (depth estimation) kept under wraps, does not favor the depth of anesthesia monitoring research. Due to the individual difference, the difference of population, the same instruments are widely used in China is not suitable for the situation of the patients. Research with independent intellectual property rights, and the economic and feasible anesthesia monitoring has important significance and value.
First of all, the design analysis of the advanced nonlinear analysis, sorting entropy algorithm, and a lot has been done on the basis of the improvement, the formation of the index, can be applied to determine the depth of anesthesia and anesthesia monitor Aspect companies in the United States acquired by the BIS index on the quantitative comparison, to obtain a relatively accurate indicator of anesthesia range. Relevant results published three papers, of which the SCI and EI, two estimation algorithm to get a sense of recognition. Anesthesia depth estimation method is to apply for patent protection. With independent intellectual property rights. High quality of brain electrical signal acquisition is the precondition of eeg analysis, brain electrical signal is weak current signal, is vulnerable to outside interference, the digital signal processing technology based on DSP and 16 bit high precision AD. Accurate differential amplifier and efficient digital filter is one of the characteristics of this design. Sort based on entropy of depth of anesthesia monitoring, in addition to the core order entropy algorithm, also need to consider the beta of brain electrical signal ratio, the outbreak of rejection ratio and other parameters. Complex algorithm, large data processing. Ordinary embedded platform is not suitable for implementation of the algorithm. At the same time, considering the need to do a lot of clinical data analysis. The main monitoring system USES the Windows xp operating system. Can be used for subsequent analysis of the data processing. System at the same time, considering the stability and the need of commercialization, also developed a software based on open source operating system Linux environment. The commercial application of can. Anesthesia care, meanwhile, must through the analysis of the large clinical verification, the system in addition to the analysis of large amounts of data based on the BIS system, in the domestic, qinhuangdao people's hospital, Beijing university people's hospital day town, county hospital and other hospitals do a lot of analysis of the clinical application. System monitoring of friendly interface, convenient operation, using the 220 v power supply, a 14.1 -inch touch screen, the main processor USES the atom industrial motherboard, and amplifier using USB communication mode of communication.
Awareness in the process of design, the purpose of the invention: anesthesia recovery (known) was a terrible experience, causes include insomnia, nightmare, the psychological mood disorders and post-traumatic stress disorder and other sequelae. Caused by the anesthesia or associated with anesthesia accidents have occurred. Anesthesia monitoring in China is still a big gap from abroad. And foreign anesthesia monitor is expensive, and its design algorithm validation based on foreign people. Design is suitable for our country crowd anesthesia depth monitoring is of great significance. Design basic idea: based on the sort of entropy anesthesia depth monitoring according to the following steps: (1) the original eeg signals real-time acquisition; (2) the sort of entropy calculation paragraphs eeg signals, the outbreak of inhibition rate (Burst suppression thewire, BSR), Burst counting, Beta rate (Beta thewire) parameters such as; (3) comprehensive parameters, to identify a key link between 0-100 figures show that the depth of anesthesia. Innovation points: (1) can be set parameters of electrical filter; (2) the use of advanced order entropy algorithm. (3) high-speed AD and signal isolation technology, improve the ability of weak signal anti-jamming. Key technology: (1) to ensure that the ordering entropy as the main monitor parameters of multi-parameter monitor indexes accord with anesthesia depth index range; (2) make sure you are able to detect into the depth of anesthesia, anesthesia too deep and too shallow for alarm; (3) the system has a large amount of data storage capabilities, and can be offline data analysis, for the improvement of anesthesia monitoring technology and theoretical research to provide original clinical data. The main technical indicators: (1) anesthesia depth index range 0-100; (2) the front-end amplifier and the main controller can be separated; (3) the main controller adopts industrial-grade Intel dual-core atom, faster 1.6 G.
The anesthesia monitoring design is scientific and advanced nature is mainly manifested in: 1, adopted the advanced processing methods on pretreatment; 2, from the algorithm than the traditional monitor algorithm complexity is low; 3, on the system fully consider the cost and reliability; (4), in the actual authentication from China on the basis of the clinical. Specific as follows: the expression of brain electrical signal preprocessing: eeg is a rich source of noise and frequency band is wide (0-1000 hz), based on the improved FIR digital filter technology, fully considering the realization of the system based on DSP, realizes the real-time digital processing of eeg signals. Ordering entropy algorithm relative BIS algorithm, calculation of more than 50 times faster, and requirements about the quality of the signal is low, in extreme cases in a 5 to 7 seconds data to calculate the depth of anesthesia value, that is the strength of the BIS index can match. Anesthesia depth monitoring system software and hardware design, the instrument with DSP as kernel, peripheral including unipolar lead scalp electrode, A/D conversion, signal isolation. Meet the requirements of the clinical anesthesia monitoring function, large amount of data storage helps to condition monitoring and analysis. Operating system using both Windows and Linux model, can be used for data analysis, low cost, small volume, high precision, high speed, high real-time performance, is helpful for marketing.
Clear product interface, with a touch screen, easy to use, with stable performance industrial motherboard as a platform, reliable operation. The advantage of this design is mainly divided into the following several parts: (1) to prevent amplification distortion, magnification of brain electrical signals between 50-100, AD sampling precision of 16 bits. DSP implements band-pass filtering and frequency of the signal notch processing. (2) the depth of anesthesia monitoring algorithm through a large amount of data verification, has a good reliability and robustness. (3) the system can store more than 10 g data, and can be offline analysis. Can provide the original data for the further study of depth of anesthesia. 2, the applicable scope, This product is of wide application of * * * * has high efficacy prediction probability, and the FDA certification of anesthesia monitoring indicators BIS has the very high correlation, adapt to the entire body anesthetic care and postoperative care in the ICU. Products relative to foreign monitor of low cost, suitable for promotion in China. 3, market analysis and forecast of economic benefit The medical and health institution reform in our country, the depth of anesthesia monitoring is listed as surgery necessary facilities. In 2005, the China medical equipment market has become the world's third largest market, annual sales of 54.8 billion yuan. At the same time, this product has a broad market competitiveness overseas.
At present there have been some international company production of the depth of anesthesia monitoring, mainly has dual-frequency auditory evoked potentials index and patient state index, the index of entropy, Nacrotrend index, the index of brain function, wavelet analysis, etc. Detailed description as follows: the dual frequency index (Bispectral index scale, BIS) contains the time domain, frequency domain and higher-order spectrum variable (double) spectrum analysis three features of electroencephalogram (EEG) quantitative analysis index, integrated into a dimensionless number 100-0. In 1997 is approved by FDA as a monitoring depth of anesthesia and sedation level indicators, entered the stage of clinical application and research. Is the only one who get the FDA certification of anesthesia monitoring. Account for more than 90% of anesthesia care market. Patients condition Index (Patient State Index, PSI) is a new clinical sedation monitoring method, through collecting four eeg information, real-time diagnosis of eeg waveform, and provide the quantitative value (0-100). Currently in clinical use of PSI monitoring instrument is PSI4000. Auditory Evoked potentials Index (Auditory Evoked Potential Index, AEP) experiments show that AEP can effectively predict the patient calm in sevoflurane anesthesia depth and the cutting skin body dynamic response. Datex - Ohmeda / 5 S Entropy module, respectively the Response Entropy (State Entropy, SE) and State Entropy (Response Entropy, RE). Narcotrend index according to the "Kugler suggest Stages" classification algorithm is the depth of anesthesia is divided into six Stages in 14 levels of quantitative indicators (from shallow to deep in the order A, B0-2 C0-2, D0-2, E0, 1, F0, 1). Brain function State Index (Cerebral State Index, CSI) CSI is a son of brain electrical signal parameters adopted as a kind of adaptive neural fuzzy inference system input. It four seeds of EEG signal parameters are calculated. Wavelet analysis of the wavelet analysis is using the computer to choose of brain wave shape, it is concluded that the typical basic wavelet, and then through the different calculation methods of the typical waveforms and index.