【正文】 orrect formulations 不充分的危險警告與不正確的表達 Yes No Design Label Use error Yes Design 德信誠 培訓網(wǎng) 更多免費資料下載請進： 好好學習社區(qū) 使用誤差 No Label HUMAN FACTORS, Potential for use errors triggered by design flaws, such as:人為因素，設(shè)計缺陷而引起可能使用誤差 HAZARD APPLICABLE POTENTIAL FAILURE CAUSE OF FAILURE EFFECTS OF FAILURE RESPONSE RISK INDEX ACTION TAKEN Confusing or missing instructions for use 使用說明書使用不當或丟失 Yes No Design Label Complex or confusing control system 復(fù)雜或混亂的控制系統(tǒng) Yes No Design Label Ambiguous or unclear device state 含混不清的設(shè)計說明 Yes No Design Label Ambiguous or unclear presentation of settings, measurements or other information 設(shè)置說明，尺寸或其它介紹含混不清 Yes No Design Label Misrepresentation of results 結(jié)果誤報 Yes No Design Label Insufficient visibility, audibility of tactility 觸感的可見度，可聽度不夠 Yes No Design Label Poor mapping of controls to actions, or of displayed information to actual state 對具體的情態(tài)信息顯示，對動作的控制影象都很差 Yes No Design Label Controversial modes or mapping as pared to existing equipment 與 現(xiàn)有的裝置相比，模式和影象都有爭議 Yes No Design Label Use by unskilled/untrained personnel 設(shè)備由不熟練和沒有培訓過的人員來操控 Yes No Design Label Insufficient warnings of side effects 副作用的警告不夠完備 Yes No Design Label Inadequate Yes Design 德信誠 培訓網(wǎng) 更多免費資料下載請進： 好好學習社區(qū) warnings of hazards associated with reuse of singleuse medical devices 不適當?shù)木姘栌袉我环磸?fù)使用醫(yī)療設(shè)備 No Label Incorrect measurement and other metrological aspects. 不正確的尺寸和其它計量方法 Yes No Design Label Inpatibility with consumables/accessories/other medical devices 與耗材，附件或其它醫(yī)療設(shè)備不相容 Yes No Design Label Slip, laps and mistakes 錯誤 Yes No Design Label FAILURE MODES 錯誤模式 HAZARD APPLICABLE POTENTIAL FAILURE CAUSE OF FAILURE EFFECTS OF FAILURE RESPONSE RISK INDEX ACTION TAKEN Unexpected loss of electrical/mechanical integrity 電氣機械完善的不可預(yù)測的損耗 Yes No Design Label Deterioration in function (. gradual occlusion of fluid /gas path, or change in resistance to flow, electrical conductivity) as a result of ageing, wear and repeated use 功能退化（液體氣路 逐漸堵塞或在抵抗流量電導率方面的改變） Yes No Design Label Fatigue failure疲勞破損 Yes No Design Label Inadequate warnings of hazards associated with incorrect formulations 不充分的危險警示并拌有不正確的說明 Yes No Design Label Use error 使用失誤 Yes No Design Label Conclusion: It has been concluded through the process of risk analysis that this is a low risk device and any risks that existed were eliminated or reduced through safety testing, proper choice of materials, sterilization validation, and thorough instructions for use. The risk analysis was evaluated in regarding the European Medical Device Directives (MDD), Annex 1, Chapter 1, point 1 and 2.” 結(jié)論： 德信誠 培訓網(wǎng) 更多免費資料下載請進： 好好學習社區(qū) 通過風險的過程分析我們從中可以得出結(jié)論，這是一個低風險的設(shè)備．經(jīng)過安全測試選擇合適的材料，有效消毒，認真閱讀使用說明書，何存在的風 險都是可以排除的或者說是可以減少的．依照有關(guān)的歐洲醫(yī)療設(shè)備法令第一章，第一和二節(jié)的附件一．可以評估分析風險．