中正大學課程大綱
資訊工程研究所

課程名稱(中文)

醫療電子臨床導入 

開課單位:

資訊工程研究所 

課程名稱(英文)

Clinical Applications of Medical Electro 

課程代碼:

4105597_01 

授課教師:

劉偉名 

學分數:

/選修:

選修 

開科年級:

大三以上 

先修科目或
先備能力:

 

課程概述:

這門課的目的是讓學生將所學應用於醫療產業時能具備基礎之知識與視野。同學將學習生醫信號量測與分析方法, 以及開發醫療電子器材時, 其軟硬體認證之相關法規,課程中會參訪醫院並與醫事人員交流。修課同學在基礎法規與醫學課程後,可結合生醫信號量測工具提出創新的醫療電子器材與資訊應用構想,除了在課堂上報告其創意、理論基礎、市場調查及所需經過的醫療認證程序外,也鼓勵將此構想與醫事人員討論以符合實際需要與商業模式。課程結束後可學習到醫療電子與資訊軟硬體的基礎知識, 並培養評估臨床應用可行性的能力。
 

學習目標:

1.了解醫療電子器材軟硬體認證之相關法規
2.
具有基礎生醫信號量測與特徵分析的能力
3.
了解醫療電子器材軟硬體的臨床需求
4.
學習從醫事人員, 病人, 與企業的角度看醫療器材研發

教科書:

Design and Development of Medical Electronic Instrumentation: A Practical Perspective of the Design, Construction, and Test of Medical Devices by David Prutchi, and Michael Norris. ISBN-13: 978-0471676232

生物醫學工程導論, by 中華民國生物醫學工程學會, 滄海書局, ISBN: 9789866507038 



課程大綱

分配時數

核心能力

備註

單元主題

內容綱要

講授

示範

習作

其他

課程簡介與醫學倫理 

醫學倫理、各國醫療法規介紹、台灣醫療法規介紹、台灣醫電產業前景與方向、人體臨床試驗法規介紹 

 

 

 

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人體可量測之生醫信號及其臨床價值 

生理學 

 

 

 

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生醫信號之量測原理,軟硬體設計, 與資料分析 

各子系統介紹, 心電圖, 腦電圖, 肌電圖, 心音, 血壓, 血氧量測實驗與信號分析 

24 

 

 

 

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醫療儀器認證法規及使用安全規範 

醫電器材查驗登記法規與過程(US FDA, Taiwan FDA) 

 

 

 

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醫療電子器材軟硬體:創新構想與個案討論 

以法規、製造品質、查驗登記等考量,討論個案構想的設計因素 

 

 

 

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醫電器材上市經驗談 

醫電器材上市經驗談、包括:創意發想、智財保護、臨床試驗、優良製造系統、查驗登記申請、後市場使用監控 

 

 

 

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醫療器材臨床試驗 

醫療器材軟硬體的試驗方法與實務 

 

 

 

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個案討論與成果報告 

以技術、法規、製造品質、查驗登記、臨床試驗等考量,討論其構想之設計因素 

 

 

 

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教育目標

1.G1. 具獨立從事學術研究或產品創新研發之人才

2.G2.. 具團隊合作精神及科技整合能力,並在團隊中扮演領導、規劃、管理之角色

3.G3.. 具創新研發、自我挑戰與終身學習能力之人才

4.G4.. 具有學術倫理、工程倫理、國際觀之人才

 

核心能力

1.1. A1.具有資訊工程與科學領域之專業知識。(Competence in computer science and computer engineering.)

1.2. A2.具有創新思考、問題解決、獨立研究之能力。(Be creative and be able to solve problems and to perform independent research.)

1.3. A3.具有撰寫中英文專業論文及簡報之能力。(Demonstrate good written, oral, and communication skills, in both Chinese and English.)

1.4. A4.具有策劃及執行專題研究之能力。(Be able to plan and execute projects.)

1.5. A5.具有溝通、協調、整合及進行跨領域團隊合作之能力。(Have communication, coordination, integration skills and teamwork in multi-disciplinary settings.)

1.6. A6.具有終身學習與因應資訊科技快速變遷之能力。(Recognize the need for, and have the ability to engage in independent and life-long learning.)

1.7. A7.認識並遵循學術與工程倫理。(Understand and commit to academic and professional ethics)

1.8. A8.具有國際觀及科技前瞻視野。(Have international view and vision of future technology.)

(Please respect to the intellectual property rights, do not photocopy the textbooks which assigned by professors.)

 

教學要點概述:

1. 教材編選:自編教材 教科書作者提供

2. 教學方法:投影片講述 板書講述

3. 評量方法:上課點名 0%, 小考 0%, 作業 30%, 程式實作 30%, 實習報告 0%,
                       
專案 20%, 期中考 0%, 期末考 0%, 期末報告 30%, 其它 10%

4. 教學資源:課程網站 教材電子檔供下載 實習網站

5. 教學相關配合事項:

 

課程目標與教育核心能力相關性          如有未出現的核心能力,請先按『確定』送出資料

請勾選:1.11.21.31.41.51.61.71.8

1.1

A1.具有資訊工程與科學領域之專業知識。(Competence in computer science and computer engineering.)

為何有關:
Students will learn signal processing from both hardware and software aspects. They will also learn the basic physiology, clinical experiments design, and regulations.

達成指標:
Students will learn signal processing from both hardware and software aspects, the basic physiology, clinical experiments design, and regulations.

評量方法:
Expected final grade: Level 5
80 and above; Level 470-79; Level 360-69; Level 250-59; Level 1<50.

1.2

A2.具有創新思考、問題解決、獨立研究之能力。(Be creative and be able to solve problems and to perform independent research.)

為何有關:
They will come up with new ideas about medical devices, and try to make their designs to fulfill all requirements.

達成指標:
Come up with a well-defined and implementable idea about medical devices

評量方法:
Expected grade from the project, term paper, and class participation: Level 5
80 and above; Level 470-79; Level 360-69; Level 250-59; Level 1<50.

1.3

A3.具有撰寫中英文專業論文及簡報之能力。(Demonstrate good written, oral, and communication skills, in both Chinese and English.)

為何有關:
A certain level of report writing and public speaking is required.

達成指標:
Students will write term papers and also present their ideas.

評量方法:
Expected grade from the term paper and final presentation: Level 5
80 and above; Level 470-79; Level 360-69; Level 250-59; Level 1<50.

1.4

A4.具有策劃及執行專題研究之能力。(Be able to plan and execute projects.)

為何有關:
They will be asked to do literature survey for their ideas, and also find solutions regarding to the engineering side of the application.

達成指標:
To see if their ideas and solutions are mature

評量方法:
Expected grade from the term paper and final presentation: Level 5
80 and above; Level 470-79; Level 360-69; Level 250-59; Level 1<50.

1.5

A5.具有溝通、協調、整合及進行跨領域團隊合作之能力。(Have communication, coordination, integration skills and teamwork in multi-disciplinary settings.)

為何有關:
Students will be asked to form groups and come up with one idea for each group after discussion with other members.

達成指標:
A complete and successful term paper and presentation.

評量方法:
Expected grade from the research journal, term paper, and evaluations to other group members: Level 5
80 and above; Level 470-79; Level 360-69; Level 250-59; Level 1<50.

1.6

A6.具有終身學習與因應資訊科技快速變遷之能力。(Recognize the need for, and have the ability to engage in independent and life-long learning.)

為何有關:
The course arrangements make students to learn things different from their original training. In addition they need to apply what they have learned in computer engineering to medical field.

達成指標:
A complete and successful term paper and presentation.

評量方法:
Expected grade from class participation and term paper: Level 5
80 and above; Level 470-79; Level 360-69; Level 250-59; Level 1<50.

1.7

A7.認識並遵循學術與工程倫理。(Understand and commit to academic and professional ethics)

為何有關:
Regulations and ethics about clinical studies will be discussed in this course.

達成指標:
In the term paper, the proposed idea about the new medical devices can follow the right procedures to pass all hypothetical regulations.

評量方法:
Expected grade from parcipation of engineering/medical ethics class, certificate/regulation class, and term paper: Level 5
80 and above; Level 470-79; Level 360-69; Level 250-59; Level 1<50.

1.8

A8.具有國際觀及科技前瞻視野。(Have international view and vision of future technology.)

為何有關:
The course includes medical devices regulations established by not only Taiwan FDA but also organizations from USA or Europe. Students will also gain insights from visiting hospitals and communications with clinicians.

達成指標:
Students equip with the knowledge about medical devices regulations established by other countries. Students are aware of the current technologies used by medical field.

評量方法:
Expected grade from class participations and term paper: Level 5
80 and above; Level 470-79; Level 360-69; Level 250-59; Level 1<50.