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【上篇】FDA关于电外科器械警告事项的特殊要求

时间:2022-12-01- 来源:天天游戏·(中国)


在申请510(K)时,如果产品被分类为Section 878.4400 Electrosurgical cutting and coagulation device and accessories, 那么FDA建议在说明书的警告事项里加入以下内容(如适用):


a

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.

在未先咨询合格的专业人士(例如心脏病专家)的情况下,请勿在植入电子植入物(例如心脏起搏器)的患者中使用。存在可能的危险,因为可能会干扰电子植入物的动作,或者可能会损坏植入物。


b

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.

请勿在存在易燃麻醉剂或氧化气体(例如一氧化二氮 (N2O) 和氧气)或靠近挥发性溶剂(例如乙醚或酒精)的情况下使用,否则可能会发生爆炸。


c

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.

请勿将器械放置在易燃材料附近或与其接触(例如纱布或手术单)。已启动或因使用而变热的仪器可能会引起火灾。


d

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.

    不使用仪器时,将其放置在清洁、干燥、高度可见的区域,不与患者接触。不慎接触患者可能会导致烧伤。


e

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.

   每次使用前检查器械和电缆是否损坏,尤其是腹腔镜/内窥镜器械的绝缘层。这可以在放大下目视完成或使用高压绝缘测试设备来完成。绝缘故障可能会导致患者或操作员烧伤或其他伤害。


f

The surface of the active electrode may remain hot enough to cause burns after the RF current is deactivated.

    射频电流停用后,有源电极的表面可能仍然很热,足以导致烧伤。


g

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.

由于担心电外科副产品(例如组织烟羽和气溶胶)具有致癌和传染的可能性,开放式和腹腔镜手术中均应使用防护眼镜、过滤面罩和有效的排烟设备。


h

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.

仅当电源关闭时才将适配器和附件连接至电外科手术装置。否则可能会导致患者或手术室人员受伤或触电。


i

If the device is argon enhanced, you should include warnings and recommendations regarding gas embolisms.

如果设备采用氩气增强,则应包含有关气体栓塞的警告和建议。


j

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.

如果仪器可重复使用,还应警告仅目视检查可能不足以确保绝缘完好无损。


k

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.

    请勿在未接触目标组织时启动仪器,因为这可能会因与其他手术设备的电容耦合而造成伤害。


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