医疗器械注册证编号:苏械注准20212020507
产品技术要求编号:苏械注准20212020507
生产许可证编号:苏食药监械生产许20200074 号
一、产品名称、型号规格、结构组成
1.产品名称:一次性使用带光源肛门镜
2.型号规格:HF-GMJ
3.结构组成:一次性使用带光源肛门镜由镜体、手柄、导光柱、可拆卸光源组成。(结构示意图见图1)
![](data:image/png;base64,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)
(1).镜体
(2).手柄
(3).可拆卸光源
(4).导光柱
二、一次性使用带光源肛门镜分类
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按防电击类型分类:内部电源设备;
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按防电击程度分类:B型应用部分;
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按对进液的防护程度分类:IPX0;
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设备不能在与空气混合的易燃麻醉气或与氧或氧化亚氮混合的易燃麻醉气情况下使用;
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按运行模式分类:连续运行;
设备不具有对除颤放电效应防护的应用部分;
三、一次性使用带光源肛门镜正常工作条件
环境温度:+10℃~+40℃;
相对湿度:30%~80%;
大气压力:700hPa~1060hPa;
电源电压:d.c.(4.05 V~4.95V)。
四、一次性使用带光源肛门镜禁忌症
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肛门、直肠狭窄患者;
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肛门和直肠有急性感染或者剧烈疼痛者,比如肛裂、脓肿;
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急性重度结肠炎、重度放射性肠炎患者;
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腹腔内广泛粘连患者;
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急性弥漫性腹膜炎患者;
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严重腹水、妊娠妇女患者;
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癌症晚期伴有腹腔内广泛转移者;
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严重心肺功能衰竭、严重高血压、脑血管病病变、精神异常及昏迷患者。
五、产一次性使用带光源肛门镜品性能
肛门镜外形光滑、轮廓清晰,无毛刺、飞边、划伤、缩瘪等缺陷。肛门镜承受50N的压力后应不开裂,镜体与手柄的连接牢固度不小于10N。
肛门镜的基本尺寸 单位:㎜
六、一次性使用带光源肛门镜适用范围
该产品用于肛肠科检查治疗使用。
七、一次性使用带光源肛门镜使用步骤
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先用75%酒精擦拭可拆卸光源外表面三遍,按下开关,再装入肛门镜中;
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消毒病人肛门部位;
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取出肛门镜,将光源装入扩张器孔内,在扩张器头部涂上石蜡油或其他润滑剂;
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用左手拇、食指将右臀拉开,显示出肛门口,右手将肛门镜抵压肛门口,用扩张器头部按摩肛缘。待肛门松驰时,将肛门镜朝脐孔方向缓慢插入,通过肛管后改向骶凹,同时需嘱病人作张口呼吸或排便动作。
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检查完毕后取出肛门镜;
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将手柄与扩张器分离,取出光源并关闭;
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手柄装配上扩张器后丢入医疗废弃桶。
八、一次性使用带光源肛门镜维护和保养方法
包装后的产品应贮存在通风良好,相对湿度不超过80%,无腐蚀性气体、通风、避光的室内。
九、一次性使用带光源肛门镜失效日期
本产品经环氧乙烷灭菌后,灭菌有效期三年,失效日期见标签。
十、一次性使用带光源肛门镜配件清单
无
十一、一次性使用带光源肛门镜注意事项、警示
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本器械仅供有资质的医护人员在医疗单位使用。
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本产品使用时,应严格执行无菌操作规范。
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使用前请检查产品是否在有效期内,灭菌有效期为三年,超过有效期的产品严禁使用;
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使用前请认真阅读本使用说明书、注意产品生产日期及批号,逾期不得使用。
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使用前请仔细检查本产品的包装,如有吸塑包装破损请停止使用。
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电池储存期限为三年,使用前请检查光源,灯光目视微弱时请更换电池,电池型号为LR44。
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本产品采用环氧乙烷灭菌,以灭菌制品供临床使用。
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本产品为一次性使用,用后不能再灭菌;
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本产品为一次性使用器械,用后必须毁形后销毁,使其零部件不再具有使用功能,并经消毒无害化处理。电子部分应作为电子器材处理。