天天游戏

联系我们       中文  |  English

联系我们

CONTACT US
服务热线:
021-33561520

上海

地址:上海市闵行区万源路585弄2号4层

邮箱:allan.zhang@llins-service.com

联系人:张 斌 13916265813(微信同号)

         

杭州

地址:浙江省杭州市滨江区滨盛路1509号天恒大厦1012室

邮箱:chunquan.song@llins-service.com

联系人:宋春权 18358500842(微信同号)

【下篇】FDA关于电外科器械警告事项的特殊要求

时间:2022-12-04- 来源:天天游戏·(中国)

对于单极电外科器械,还需在说明书的警告事项中另加上以下几条(如适用):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.


m

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.

使用单极有源组件时,请勿与混合套管针系统(如金属和塑料的组合)一起使用。这可能会因电容耦合而导致交替部位烧伤。仅使用全金属或全塑料套管针系统。



n

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.

在增加强度之前,检查中性电极及其连接的附着力。明显的低输出或设备在正常操作设置下无法正常工作可能表明中性电极应用错误或其连接接触不良。



o

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.

如果设备使用中性电极且没有 CQM,则应添加警告,表明中性电极与患者之间失去安全接触不会导致警报。



P

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.

如果设备使用中性电极并且确实具有 CQM,则应添加警告,表明中性电极与患者之间失去安全接触不会导致警报,除非使用兼容的监测中性电极。



天天游戏·(中国)

扫码关注 了解更多

640.jpg


相关资讯RELATED NEWS
站点地图-xml  
天天游戏·(中国)澳门新京6692am中国有限公司  开元体育  千亿游戏官网股份有限公司  pg电子平台(中国)官方网站  买球赛的网站_腾讯指南