- 學位論文
血氧濃度計相關技術之綜合分析
Comprehensive analysis of the relevant technologies of pulse oximeter
摘要
血氧濃度計提供一種經驗量測動脈血液氧氣濃度的方法。然而，隨著儀器及校正技術的發展與進步，發現血氧濃度計在當SaO2數值超過80%以上時，其誤差值只有3%，能滿足臨床上偵測動脈缺氧的需要。因此血氧濃度計能夠迅速地被接受並成為監測生理參數的設備，廣泛地運用於手術室、麻醉恢復室、重症照護ICU等環境。其優點在於它是以非侵入式的、連續性的方式，並且能夠立即的使用所量測到的資料。 本研究以不同觀點來分析血氧濃度計，從基本的原理介紹、專利分析、關鍵技術探討與醫療儀器法規驗證程序說明等，以綜合的觀點來分析血氧濃度計這項醫療器材，讓有興趣的開發者可作為投入研究前的參考。 血氧濃度計信號常會受到光線影響、移動干擾、低灌注或染劑…等因素造成所獲得的信號不正確，因而造成量測到的血氧濃度數值不準確。分析專利的過程中得知Masimo公司的專利技術Masimo SET在數位信號處理這部分投入相當多的心力，專長在提供血氧濃度計遭遇低灌注與移動干擾等問題的解決方案，他們在經過相關的臨床實驗與研究報告中證實可以有效的改善這些問題。並且在專利領域中也獲得了一個相當領先的優勢。 血氧濃度計產品在美國上市須通過FDA的510(K)認證，其參考的國際標準為ISO 9919-2005，主要的認證方式是採實質相等性的原則。而歐盟的驗證則參考BS EN ISO 9919-2005，以第三認證機構Notified Body的方式進行驗證，在新公布的2007/47/EC規定所有申請CE認證之醫療器材必須提供其臨床評估之資料。在台灣則大致參照美國的實質等效性的原則進行相關的驗證。
並列摘要
Pulse oximeter to provide an experience of measuring arterial blood oxygen concentrations. However, with the instruments and calibration technology development and progress, found that pulse oximeter SaO2 values in more than 80% as above, only 3% of their errors, which can meet the needs of detecting arterial hypoxia. Therefore, pulse oximeter can be quickly accepted and physiological parameters of monitoring devices, widely used in the operating room, anesthesia recovery room, ICU and other critical care environment. The advantage is that it is non-invasive, continuous way, and can immediately use the measured data. This study uses a different point of view of pulse oximeters, from the basic principles of description, patent analysis, key technology and medical device laws and regulations of the verification process descriptions, a comprehensive point of view of the medical equipment pulse oximeter, so that Interested developers can be used as a reference in research before. Pulse oximeter signal often affected by light, motion artifacts, low perfusion or agent of factors ... such as the signal received is incorrect, resulting in the measured oxygen concentration value is not accurate. Analysis of the process patent that Masimo Masimo SET's patented technology in digital signal processing into this part a lot of effort, expertise, experience in the provision of low perfusion pulse oximeter interference with the mobile solution to the problem, they pass the relevant Experimental and clinical studies confirmed that these problems can be effectively improved. And in the field of patents has also acquired a considerable lead. Pulse oximeter products in the United States are required to pass FDA's 510 (K) certification, the reference to the international standards ISO 9919-2005, the main authentication method is to adopt the principle of substantive equality. Verification of the EU, reference is BS EN ISO 9919-2005, to the third way Notified Body certification body to verify, in the newly published 2007/47/EC requirements for CE certification of all medical devices must provide clinical assessment information. In Taiwan, the United States is largely on the principle of substantial equivalence of the relevant verification.