對于單極電外科器械，還需在說明書的警告事項中另加上以下幾條（如適用）：1. ASPIRATE fluid from the area before activating the instrument. Conductive fluids (e.g. , blood or saline) in direct contact with or in close proximity to an active electrode may carry electrical current or heat away from target tissues, which may cause unintended burns to the patient.
DO NOT USE with hybrid trocar systems, i.e., a combination of metal and plastic, when using monopolar active components. This may result in alternate site burns due to capacitive coupling. Use only all-metal or all-plastic trocar systems.
使用單極有源組件時，請勿與混合套管針系統(tǒng)（如金屬和塑料的組合）一起使用。這可能會因電容耦合而導致交替部位燒傷。僅使用全金屬或全塑料套管針系統(tǒng)。
Prior to increasing the intensity, check the adherence of the neutral electrode and its connections. Apparent low output or failure of the device to function correctly at the normal operating settings may indicate faulty application of the neutral electrode or poor contact in its connections.
在增加強度之前，檢查中性電極及其連接的附著力。明顯的低輸出或設備在正常操作設置下無法正常工作可能表明中性電極應用錯誤或其連接接觸不良。
If the device uses a neutral electrode and does not have a CQM, you should include a warning that loss of safe contact between the neutral electrode and the patient will not result in an alarm.
如果設備使用中性電極且沒有 CQM，則應添加警告，表明中性電極與患者之間失去安全接觸不會導致警報。
If the device uses a neutral electrode and does have a CQM, you should include a warning that loss of safe contact between the neutral electrode and the patient will not result in an alarm unless a compatible monitoring neutral electrode is used.
如果設備使用中性電極并且確實具有 CQM，則應添加警告，表明中性電極與患者之間失去安全接觸不會導致警報，除非使用兼容的監(jiān)測中性電極。
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