在申請(qǐng)510（K）時(shí),如果產(chǎn)品被分類為Section 878.4400 Electrosurgical cutting and coagulation device and accessories， 那么FDA建議在說(shuō)明書的警告事項(xiàng)里加入以下內(nèi)容（如適用）：
DO NOT USE in patients who have electronic implants such as cardiac pacemakers without first consulting a qualified professional (e.g., cardiologist). A possible hazard exists because interference with the action ofthe electronic implant may occur, or the implant may be damaged.
在未先咨詢合格的專業(yè)人士（例如心臟病專家）的情況下，請(qǐng)勿在植入電子植入物（例如心臟起搏器）的患者中使用。存在可能的危險(xiǎn)，因?yàn)榭赡軙?huì)干擾電子植入物的動(dòng)作，或者可能會(huì)損壞植入物。
DO NOT USE in the presence of flammable anesthetics or oxidizing gases (such as nitrous oxide (N2O) and oxygen) or in close proximity to volatile solvents (such as ether or alcohol), as explosion may occur.
請(qǐng)勿在存在易燃麻醉劑或氧化氣體（例如一氧化二氮 (N2O) 和氧氣）或靠近揮發(fā)性溶劑（例如乙醚或酒精）的情況下使用，否則可能會(huì)發(fā)生爆炸。
DO NOT place instruments near or in contact with flammable materials (such as gauze or surgical drapes). Instruments that are activated or hot from use may cause a fire.
請(qǐng)勿將器械放置在易燃材料附近或與其接觸（例如紗布或手術(shù)單）。已啟動(dòng)或因使用而變熱的儀器可能會(huì)引起火災(zāi)。
When not using instruments, place them in a clean, dry, highly visible area not in contact with the patient. Inadvertent contact with the patient may result in burns.
不使用儀器時(shí)，將其放置在清潔、干燥、高度可見的區(qū)域，不與患者接觸。不慎接觸患者可能會(huì)導(dǎo)致燒傷。
INSPECT instruments and cables for damage prior to each use, especially the insulation of laparoscopic/endoscopic instruments. This may be done visually under magnification or with a high voltage insulation testing device. Insulation failures may result in burns or other injuries to the patient or operator.
每次使用前檢查器械和電纜是否損壞，尤其是腹腔鏡/內(nèi)窺鏡器械的絕緣層。這可以在放大下目視完成或使用高壓絕緣測(cè)試設(shè)備來(lái)完成。絕緣故障可能會(huì)導(dǎo)致患者或操作員燒傷或其他傷害。
The surface of the active electrode may remain hot enough to cause burns after the RF current is deactivated.
射頻電流停用后，有源電極的表面可能仍然很熱，足以導(dǎo)致燒傷。
Due to concerns about the carcinogenic and infectious potential of electrosurgical byproducts (such as tissue smoke plume and aerosols), protective eyewear, filtration masks, and effective smoke evacuation equipment should be used in both open and laparoscopic procedures.
由于擔(dān)心電外科副產(chǎn)品（例如組織煙羽和氣溶膠）具有致癌和傳染的可能性，開放式和腹腔鏡手術(shù)中均應(yīng)使用防護(hù)眼鏡、過(guò)濾面罩和有效的排煙設(shè)備。
Connect adaptors and accessories to the electrosurgical unit only when the energy is off. Failure to do so may result in an injury or electrical shock to the patient or operating room personnel.
僅當(dāng)電源關(guān)閉時(shí)才將適配器和附件連接至電外科手術(shù)裝置。否則可能會(huì)導(dǎo)致患者或手術(shù)室人員受傷或觸電。
If the device is argon enhanced, you should include warnings and recommendations regarding gas embolisms.
如果設(shè)備采用氬氣增強(qiáng)，則應(yīng)包含有關(guān)氣體栓塞的警告和建議。
If the instrument is reusable, you should also include a warning that visual inspection alone may not be sufficient to ensure that the insulation is intact.
如果儀器可重復(fù)使用，還應(yīng)警告僅目視檢查可能不足以確保絕緣完好無(wú)損。
DO NOT activate the instrument when not in contact with target tissue, as this may cause injuries due to capacitive coupling with other surgical equipment.
請(qǐng)勿在未接觸目標(biāo)組織時(shí)啟動(dòng)儀器，因?yàn)檫@可能會(huì)因與其他手術(shù)設(shè)備的電容耦合而造成傷害。
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