故障模式與影響分析(FMEA)應用於移動式心電圖機之設計

Applying Failure Mode and Effect Analysis (FMEA) in ECG Holter Design

薛旭欽(Hsu-Chin Hsueh)

指導教授 ： 李仁貴

國立臺北科技大學/電資學院/電腦與通訊研究所/碩士(2007年)

摘要

有關移動式心電圖機(Holter)的設計，以往大多以技術面來探討功能應用上的可行性，但在實際使用Holter時，除了技術功能外尚須考量使用的安全性，例如使用Holter時可能因人為操作不當或電極鬆脫造成量測失效，或因Holter設計不良造成漏電而直接導致患者的傷害，或因保護不足使得靜電或電擊突波造成Holter故障，而使Holter失去應有的監測功能。
在本文中將以安全面來探討使用Holter的風險，並導入故障模式與影響分析(FMEA)來探索造成Holter使用時量測失效或引起Holter故障的原因，並提出保護電路及警示系統二個風險處理對策，以及利用FMEA的風險優先指數(RPN)值來作為風險評估指數，用以評量風險處理對策實施前後的差異性，以驗證風險處理對策的有效性。
在經由保護電路對患者與Holter的防護，以及警示系統對患者的通報，可提供患者一個可靠無障礙的人機操作介面，以降低患者使用Holter的風險，同時也有利於降低Holter的製造商在經營上的風險。

關鍵字

移動式心電圖機 ； 故障模式與影響分析 ； 風險優先指數 ； 保護電路 ； 警示系統 ； 患者 ； 傷害 ； 風險處理對策 ； 製造商

並列摘要

In regard to the design of ambulatory electrocardiographic equipment (Holter), the availability of functional application used to be explored mostly based on technical aspect. However, during the operation of Holter, in addition to its technical function, the safety in use needs considering. For example, the use of Holter may lose its effects due to improper human operation or the slip of electrodes. Otherwise, the poor design of Holter results in electricity leak and thus directly leads to patient’s injury. Or, insufficient protection brings about Electrostatic Discharge or electrosurgery causes Holter’s failure and thus deprives Holter of its built-in monitoring function.
This thesis aims to explore the risk of using Holter based on safety aspect, and with the lead-in of FMEA this thesis explores the reasons why Holter loses its effects or why Holter fails in measuring. In addition, two risk treatment strategys are brought out, which are the protection of circuit and warning system, and the use of Risk Priority Numbers, in order to evaluate the variance between before and after implementation of risk treatment strategies and certificate the efficiency of risk treatment strategys.
By means of the protection of electric circuit on patient and Holter, and the communication of warning system to patient, patient can be provided with a reliable and clear human-machine operational interface. Thus, the risk of patient with Holter can be reduced and the management risk of Holter manufacturers can also be decreased.

並列關鍵字

Holter ； Failure Modes and Effect Analysis(FEMA) ； Risk Priority Number (RPN) ； protection circuits ； warning system ； patient ； harm ； risk treatment strategy ； manufacturer

參考文獻

[23]劉名修，具警報機制之智慧型行動照護系統，碩士論文，台北科技大學電腦通訊與控制研究所，台北，民國93年。

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