2019年5月19日

I am an expert of biomedical engineering.

I am an expert of biomedical engineering. I have exceeded decade years’ experience of medical device research and development. My BS degree is Biomedical Engineering, Chung Yuan Christian University and I obtained master and doctor degree at Graduate Institute of Electrical Engineering, National Taiwan University.


I have medical physiology expertise and electronic information engineering expertise, and have more than 10 years of practical experience in the industry, familiar with system integration and design planning, and long-term investment in biomedical related equipment and software systems. After many years of experience in production, research and research, I specialize in research and development of practical technical details, specializing in product planning, research and development integration, product practice, R&D management practice, reviewing detailed technology, familiar with international standards and regulatory requirements related to medical equipment, and possessing project leadership management and Technological innovation ability, from EVT, DVT, PR, MP to sales, rapid development of medical equipment that can be certified by medical, can lead the team to develop commercial medical equipment and system equipment.


2019年5月13日

我的人工智慧(專家系統)研究經歷

我的人工智慧(專家系統)研究經歷如下:

(1). 修習台大資工研究所「專家系統」課程,獲學習成績 92 分。
(2). 使用 CLIPS 程式語言建構「休克(Shock)輔助診斷專家系統」,輔助急診醫學應用。
(3). 發表期刊論文:
Cheng, Y.P.*, & Chou, A. N. G. 2011 April, Bi-level weights sum method for shock diagnosis, Expert Systems with Applications Vol.38 Issue 4, pp. 4497-4504. (SCI, 2017 IF=3.768, Rank=20/132 15.15% in subject categories COMPUTER SCIENCE, ARTIFICIAL INTELLIGENCE)


2019年5月12日

臨床評估報告 Clinical Performance Evaluation Report, MEDDEV 2.71 Rev. 4, 2016.

我在 2018 年公司的 CE 稽核時完成了 Clinical Performance Evaluation Report, MEDDEV 2.71 Rev. 4, 2016.的撰寫。因為是最新的修正,連稽核老師也不知道詳細內容,只能要求我方完全按照文件內所要求的內容全部都要寫上去,這真的是艱難的任務,但我還是完成了。

MDR 法規將取代醫療器材指令(Medical Device Directive, MDD, 93/42/EEC)和主動植入式醫療器材指令(Active Implantable Medical Device Directive, AIMD, 90/385/EEC),將原先醫療器材指令整合、升級成法規(Regulation),藉此提高對歐盟成員國的約束力。新法規大幅提升有關醫材認證的規範與限制,例如關於醫材分級便增加至超過 20 條規範,增加醫材追溯性、臨床試驗規範嚴謹度、臨床證據的掌握度與增加上市後的產品安全性與效能監督。

其中,增強臨床評估與臨床證據監管。MDR 要求醫材製造商必須進行臨床性能(performance)研究,依器材風險等級提供其安全性及性能相稱的臨床證據,並收集、保留上市後的臨床資料,以持續評估產品的潛在安全風險。

屬 Class Ⅲ 醫材與植入物,若需進行實質相等性(substantially equivalent)比對也有更嚴格的規定,(1) 僅能與製造者自己生產的設備進行比對;(2) 欲與其他製造商的設備進行相等性比對,雙方必須先簽訂合約方可進行。

Clinical Performance Evaluation Report, MEDDEV 2.71 Rev. 4, 2016.這份報告,並不是一般人就可以寫得,是有規範撰寫人的資格的:



ANSWatch 心律大師 中醫應用

除了量測血壓,HRV,心跳,及心律不整外,最新型的心律大師已兼具脈象分析(卽脈診儀)功能。

雖然心電圖機(ECG或EKG)也可以透過心電訊號量測HRV,但對於心臟打血及血液循環狀況都無法得知。

心律大師利用腕帶內獨家特製的生物感應器(美國,台灣,中國大陸專利),直接測得手橈動脈(卽中醫師把脈處)之血壓波完整的動脈血壓波型,蘊含有多重生理資料,包括心肌收縮打血,大動脈閥(Aortic Valve)開合,二尖瓣膜心閥閉鎖,及周邊血管阻力等。

詳細資訊可參見:心律大師脈象分析



2019年5月8日

ANSWatch 心律大師介紹

我曾參與心律大師早期在工研院開發時期的研究,後來計畫主持人離開工研院創立台灣科學地公司進行心律大師的開發與販售。

我之前曾協助推廣心律大師,特別建立一個專業的部落格 HRV and ANS 心跳變異性 與 自律神經檢測,並設計 DM 進行推廣。



My Current Work -- Proton Therapy System 質子治療系統 (質子刀)

我現在的工作是開發目前最先進的癌症精準放射治療系統-質子刀(proton  therapy  system),負責最核心的控制系統規劃與設計開發,這是結合同步輻射與放射治療的領域,我從理論基礎開始學習到加速器控制系統的規劃與設計,並同時要符合FDA  510(k)  的要求。

工作內容大致如下:

Medical engineer/R&D Department,
    • Research and development of proton therapy system for Precision Radiotherapy.
    • Planning and establishing Accelerator Control System (ACS) of “iProton”.
    • ACS subsystem integration and controlling:
        ◦ Ion Source system
        ◦ LINAC system
        ◦ Magnet power supplier system
        ◦ RF synchrotron ring system
        ◦ Beam diagnostics
        ◦ Master timing system
        ◦ B-Train system
        ◦ Vacuum system
        ◦ Cooling system
        ◦ Interlock system
    • SCADA network monitoring system and Database development.
    • Integration of ACS, TCS (Treatment Control System), OIS (Oncology Information System), Dose Delivery System, Robotic Couch System, etc. for proton therapy.
    • LabView programming and establishing software system for ACS.
    • Software V&V (Verification and Validation).

2016年6月19日

脈壓差逾60 心血管硬化高危險群

新聞來源:脈壓差逾60 心血管硬化高危險群

2007-09-16

別以為血壓正常,
就不會罹患心血管疾病。
如果收縮壓及舒張壓相差超過60,
表示血管彈性變差,即使血壓正常,
仍存在心血管疾病的風險。


記者魏怡嘉/台北報導

一般人常誤以為,血壓只要在正常範圍內,就不必擔心罹患心血管疾病。不過,最近一項研究卻指出,60歲以下的成年人,如果收縮壓及舒張壓兩者的測量值若相差超過60,表示血管彈性變差,即使血壓正常,仍存在心血管硬化,導致心肌梗塞及腦中風的風險。

這項研究主要針對533名民眾進行調查分析,其中270人為高血壓病患,另外263人為非高血壓者。

台大醫院心臟科主治醫師蘇大成表示,這項研究是以參與者的頸動脈血管厚度,及頸動脈內的硬化塊做為指標,在排除有些人因主動脈閉鎖不全引起的高脈壓差後,結果發現,脈壓差會導致頸動脈血管厚度及硬化塊增加,而這是血管硬化的過程,顯示脈壓差與血管硬化有正向的關連。

蘇大成進一步指出,正常的血壓為收縮壓在120到130毫米汞柱以下,舒張壓則在80毫米汞柱以下。收縮壓會隨著年齡的增加而上升;舒張壓則會在中、老年後(男性約在55歲、女性則在60到65歲),隨著年齡的增加,而往下降。

蘇大成表示,脈壓差其實在40歲左右即漸漸增加,顯示血管彈性變差,逐漸在硬化,當年齡到了60、70歲時,兩者間的脈壓差往往愈差愈大,這也是為什麼年紀愈大,血管會愈脆弱。這些血壓相關參數的變化,在國內外的大型研究,如美國的全國營養健康調查、台灣大型的金山社區研究,以及2002年全國的三高調查中,皆有類似的發現。

雖然年紀愈大,脈壓差愈大是自然的現象,但在60歲以下的中壯年人,卻不應存在脈壓差過大的情形。蘇大成表示,研究發現,60歲以下的成年人,脈壓差如果超過60,頸動脈血管厚度及硬化塊即會明顯增加,進而導致血管硬化。

蘇大成指出,脈壓差與年齡的增加、收縮壓、糖尿病及左心室肥厚有關,60歲以下的成年人,如果有這些因子存在,就要積極注意高脈壓差的問題。

另外,高血壓的病患,其血壓的控制,不能只看收縮壓及舒張壓是否正常就好,同時還要注意脈壓差不能差太多,才能更有效降低罹患心血管疾病的風險。

2016年5月24日

Blood Pressure Waveform Analysis, 血壓波分析

I involved the project “Portable wrist physiological monitoring system for new drug side effect” of Dr. Sun at 2002-2003. I used Labview to design GUI and analysis blood waveform. This project was selected for the ITRI and MOEA best forward-looking plan. Dr. Sun now is CEO of Taiwan Scientific Corp.



此計畫為FY91 前瞻計畫「連續式,非侵入性新藥副作用監視系統」及FY92 前瞻計畫「連續式,非侵入性藥物副作用之預警監視系統」,已於美國進行臨床動物實驗及台灣三總/慈濟進行臨床測試,圖為本人所完成之血壓波分析程式。

食道壓量測信號之心跳雜訊濾除方法, Research of adaptive filtering method for removal of cardiac beat artifact in measured esophageal pressure signal.

  Information on volume-pressure relationships of human lungs is usually based on indirect determination of intrapleural pressure (Pip) obtained from the esophagus. Esophageal pressure (Pes) measurements are important in medical research and useful in clinical diagnosis. Unfortunately, the measurement results contaminate heavily by cardiac artifact and complicate further analyses. In clinical measurement of Pes, the conventional strategy to minimize cardiac beat artifact is to adjust the position of esophageal balloon or the posture of the body. Adaptive finite impulse response (AFIR) filter and modified adaptive noise cancellation (MANC) method are adopted to filter cardiac beat interference in this research. Six experiments on two Brown-Norway rats are used to verify filters’ performance and these filtered results are later compared.


  In MANC methodology, an airflow signal is used as the reference signal with least mean square (LMS) method as the adaptive algorithm. The proposed MANC filter has successfully demonstrated the ability to significantly reduce the apparent cardiac pulsation without noticeably distorting the sharp deflections in the measured Pes signal. Furthermore, the MANC filter also shows evidence of suppressing peaks at integer multiples of heart rate in the Fast Fourier Transform (FFT) of the Pes signal while leaving the remaining spectrum largely unperturbed. A t-test method and the ratio of standard deviations to means (std/mean) statistics of airway resistance (Raw) values were used to evaluate the performance of MANC filter. In all six experiments, with the MANC filter, reductions of std/mean of Raw by 12.5% to 68% were obtained.
  
  In the frequency domain, frequency variations and spectral overlap between the Pes components and cardiac beat signal components impact on the performance of filter. In this paper, the spectrum and waveform of measured Pes signal obtained after carefully adjusting the esophageal balloon are the best situation in clinical medicine and is used as the standard reference. From our experimental results on power strength, the 4th or higher harmonics did not have any significant effect on the filter performance. However, the 2nd harmonics of these signals had a significant effect on the filtering result. Thus, in the design of AFIR filters, attention is needed to minimize these effects. In frequency analysis, these harmonics or overlapping frequencies do not affect MANC. MANC is the better method for eliminating cardiac beat artifact in Pes measurement. The dynamic compliance (Cdyn) was also used to evaluate the performance of MANC and AFIR. The standard deviation of Cdyn is less than 0.15 using MANC, compared with the standard deviations as high as 0.57 for AFIR.
  
  Experimental results indicating the effectiveness of MANC scheme as a filtering method to remove the cardiac beat artifacts in Pes measurement and we can conclude that MANC has better performance than AFIR. Furthermore, the LMS algorithm is simple to implement the online signal-processing device by DSP chips. (in 2001)

這是本人之博士論文題目,研究重點如下:

肋膜壓(Pip)在肺生理是相當重要的生理參數,通常它是利用間接量測的方法由食道量測食道壓(Pes)來取代肋膜壓的量測。
但是在食道壓量測信號中,有嚴重的心跳信號的干擾,這干擾會影響到之後許多的肺生理參數的計算與分析。在臨床上,通常是以調整食道球(esophageal balloon)的位置與受測者的姿勢來降低心跳信號的干擾。
在這個研究中,適應性有限脈衝反應(Adaptive finite impulse response; AFIR)濾波器與修正型適應性雜訊消除法(modified adaptive noise cancellation; MANC)方法被使用來濾除心跳干擾。
我們使用兩隻棕色挪威鼠(Brown-Norway rats)設計了六個實驗來驗證濾波器的效能並在之後比較兩種濾波方法的優劣。

此研究已發表論文如下:

鄭怡平,Research of adaptive filtering method for removal of cardiac beat artifact in measured esophageal pressure signal. (食道壓量測信號之心跳雜訊濾除方法之研究),國立台灣大學電機工程學研究所博士論文,January, 2001.
Y.P. Cheng, H.D. Wu, G.J. Jan, and C.Y. Wang, “Adaptive method for removing cardiac beat artifact in esophageal pressure measurement”, Annals of Biomedical Enginerring, March , Vol. 29, p. 1-8, 2001. (SCI,2006 Impact Factor 2.276 )
Yi-Ping Cheng, Huey-Dong Wu, Cheng-Yi Wang and Gwo-Jen Jan, “Removal cardiac beat artifact in esophageal pressure measurement”, Medical & Biomedical Engineering & Computing, Vol. 37, Nov. p.776-783, 1999. (SCI,2006 Impact Factor 1.018)
Y.P.Cheng, H.D.Wu, G.J.Jan, “Comparing two adaptive methods for removing cardiac beat artifact in esophageal pressure measurement: MANC and AFIR”, Proceeding of the 20th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBS'98) , Hong Kong, China, pp. 1640-1642, 1998.
Yi-Ping Cheng, Gwo-Jen Jan, Hwei-Dung Wu, Cheng-Yi Wang, "Digital Filter Method for Cancellation of Heart Beat Artifact in Esophageal Pressure Measurement ", 全球華人醫學工程會議暨1996醫學工程科技研討會, Taipei, Taiwan, 五月29~30日, 1996. 



電腦輔助急症集中式監視系統, Computer assisted emergency monitoring system, CAEMS.

This system CAMES, a prototype for real-time integration of multitudinous devices into a physiological intelligent monitoring system useful in intensive care unit (ICU). An IBM compatible PC is used as a console and connects to one bedside monitor via A/D converter. A Z-80 controller is used as the slave of the console and integrates information of one ventilator and three infusion venous pumps (IV-pumps) via RS-232. The communication protocol between console and slave is the RS-232. The SCO UNIX operation system, ANSI C language and X-windows utility are used in developing CAMES. From experimental results, this system successfully provides a friendly operational interface for clinicians and nurses, integrates information from bedside devices, report patient’s state and physiological parameters, displays and records the results. It is highly effective to be used as an integrated physiological monitor, a patient information system or a computer-based patient recorder (CPR). It can be networked to the whole hospital networks. (in 1993)



這雖然是本人82年的碩士論文,但是這個觀念不僅在當時是十分先進的究領域,到現在醫院內也對此類系統有迫且需求,以衛生署新竹醫院為例,本人正是以此概念與技術為基礎協助建立檢驗儀器連線監測資訊系統。採用系統:SCO UNIX, X-windows。

概述 :
將每一病床所使用之量測儀器如Bedside monitor、IV pump、ventilator等儀器之資訊網路化,每一病房可有一主控電腦,或是一護理站一主控電腦。儀器資訊網路化後可以產生電子報表與可由遠端監控各病床之儀器資訊。

優點

具RS232埠之醫療設備均可連線上網
遠端監視病患生理參數
遠端存取並監視控醫療設備之狀態 (如: 警示…等)
病患生理參數記錄自動化,取代人工抄錄(自動化電子病歷)
病患資料輸入自動化
醫療設備之設定之自動化

可應用範例

生理參數之量測及監視設備
加護病房病人生理參數集中監視資訊系統
療養院、老人安養院病人生理參數集中監視資訊系統