厂商库克COOK血管鞘RCFN-5.0-18-MPIS-NT
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厂商库克COOK血管鞘RCFN-5.0-18-MPIS-NT
桂经理19117326863微xin同号
桂经理19117326863微xin同号
产品名称 血管鞘Check-Flo Perｆormer Introducers
管理类别 第二类
型号规格 RCF-5.0-35-J、RCF-5.0-38-J、RCF-6.0-35-J、RCF-6.0-38-J、RCF⁻⁷.0-35-J、RCF⁻⁷.0-38-J、RCF-8.0-38-J、RCF-9.0-38-J、RCF-10.0-38-J、RCF-11.0-38-J、RCF-12.0-38-J、RCF-14.0-38-J、RCF-16.0-38-J、RCFN-4.0-18-MPIS-NT、RCFN-5.0-18-MPIS-NT、RCFN-5.0-35-J、RCFN-6.0-18-13-RA2.5、RCFN-6.0-18-23-RA2.5、RCFN-6.0-18⁻⁷-RA2.5、RCFN-6.0-18-MPIS-NT、RCFN-6.0-38-J、RCFW-8.0-38-30-RB、RCFW-9.0-38-30-RB、RCFW-10.0-38-45-RB、RCFW-10.0-38-80-RB、RCFW-11.0-38-30-RB、RCFW-12.0-38-30-RB、RCFW-12.0-38-45-RB、RCFW-12.0-38-65-RB、RCFW-12.0-38-80-RB、RCFW-14.0-38-30-RB、RCFW-14.0-38-45-RB、RCFW-14.0-38-80-RB、RCFW-16.0P-38-30-RB、RCFW-16.0P-38-80-RB、RCFW-18.0P-38-30-RB、RCFW-18.0P-38-40-RB、RCFW-18.0P-38-85-RB
结构及组成/主要组成成分 血管鞘由扩张器、鞘管、鞘管座、止血阀、侧臂连接管、扩张器、导丝、穿刺针组成，不同型号规格所包含的部件类型不同。产品经环氧乙烷灭菌，一次性使用。货架有效期三年。
适用范围/预期用途 血管鞘被设计用于经皮穿刺介入血管系统，导入球囊导管、电极或导管，进行介入诊断或治疗手术。
1、工作原理 Working Principle
中文：借助导丝引导，经皮穿刺建立血管入路通道；扩张器扩张穿刺点，鞘管留置在血管内形成密闭通路；止血阀实现器械进出同时减少血液外溢；鞘管远端不透射线标记在透视下确认置入位置，为介入器械提供稳定输送通道，降低反复器械进出对血管壁的损伤。 English：Under guidewire guidance, percutaneous puncture establishes vascular access. The dilator expands the puncture site, and the sheath remains indwelling in blood vessel to ｆorm sealed access. The hemostasis valve allows instrument passage while minimizing blood leakage. Radiopaque marker at sheath tip verifies position under fluoroscopy, providing stable delivery channel for interventional devices and reducing vessel wall injury from repeated instrument exchangesCook Medic...。
2、产品功能 Product Function
中文
经皮穿刺建立并维持血管介入通路，便于导入导管、球囊、电极等诊断 / 治疗器械；
止血阀结构，器械插拔过程减少出血；侧管可用于给药、冲管、采血测压；
隔离穿刺创口，减少器械与皮肤、皮下组织摩擦，保护血管穿刺部位；
远端不透射线标记，透视下确认鞘管头端位置，辅助术中定位。
English
Establish and maintain percutaneous vascular access for introduction of diagnostic and therapeutic devices such as catheters, balloons and electrodes;
Hemostatic valve reduces bleeding during instrument insertion‑withdrawal; side port enables medication delivery, flushing and blood pressure measurement;
Isolate puncture wound, reduce friction between instruments and subcutaneous tissue, protect vascular puncture site;
Distal radiopaque marker for tip positioning under fluoroscopy。
3、产品特点 Product Features
中文
鞘管材质 RFEP（氟化乙丙烯），添加硫酸钡实现不透射线，柔韧性好，抗弯折；
集成硅胶止血阀，适配多器械通过，密封性良好；
MPIS 短头端构型，降低血管损伤风险；NT 无扭矩控制环设计；
套装含匹配扩张器、导丝，手术配套完整；
环氧乙烷灭菌，一次性使用，无热源；
薄壁大内腔设计，在 5F 外径下保障器械通过能力。
English
Sheath tube made of RFEP (radiopaque fluorinated ethylene‑propylene) doped with barium sulfate, flexible and kink‑resistant;
Integrated silicone hemostatic valve with good sealing for multiple device passage;
MPIS short‑tip configuration to reduce vascular trauma; NT version without torque control ring;
Complete set including matched dilator and guidewire for convenient clinical use;
Ethylene oxide sterilized, single‑use, non‑pyrogenic;
Thin‑wall large‑lumen design ensures adequate device passage under 5F outer diameter。
4、技术参数 Technical Parameters
中文
型号：RCFN‑5.0‑18‑MPIS‑NT
鞘管规格：5F；有效长度 18cm
鞘管材质：RFEP（含硫酸钡不透射线剂）
扩张器材质：聚乙烯
止血阀：高密度聚乙烯、硅胶；标记环铂铱合金
导丝：304 不锈钢 / 铂钨合金
灭菌方式：环氧乙烷灭菌
使用方式：一次性使用
货架有效期：3 年
部件组成：鞘管、扩张器、止血阀、鞘座、侧接头、配套导丝
English ‑Model：RCFN‑5.0‑18‑MPIS‑NT ‑Sheath size：5F；Working length 18 cm ‑Sheath material：RFEP (barium sulfate radiopacifier) ‑Dilator material：Polyethylene ‑Hemostatic valve：HDPE, silicone; marker band: platinum‑iridium alloy ‑Guidewire：304 stainless steel / platinum‑tungsten alloy ‑Sterilization：Ethylene oxide(EO) ‑Usage：Single‑use only ‑Shelf life：3 years ‑Components：Sheath, dilator, hemostatic valve, hub, side port, matched guidewire
5、使用方法 Operating Method
中文
核对包装完整性、灭菌有效期，无菌条件下打开包装取出全套组件；
肝素盐水冲洗鞘管、扩张器、侧管，排尽内部气泡；
Seldinger 技术完成血管穿刺，送入配套导丝至目标血管；
沿导丝送入扩张器预扩张穿刺通道；
保持导丝位置，将鞘管‑扩张器组件沿导丝推送入血管，透视确认鞘管头端位置；
固定鞘座，撤出扩张器与导丝，止血阀闭合；侧管肝素盐水冲洗；
通过止血阀送入介入器械开展诊断或治疗操作；
手术结束后轻柔拔出血管鞘，对穿刺点压迫止血，加压包扎。
English
Verify package integrity and sterilization expiry date; open package under aseptic condition;
Flush sheath, dilator and side‑port with heparinized saline to remove air bubbles;
Perｆorm vascular puncture via Seldinger technique, advance matched guidewire into target vessel;
Pre‑dilate puncture tract over guidewire with dilator;
Keep guidewire in‑situ, advance sheath‑dilator assembly over wire into vessel; confirm sheath tip position under fluoroscopy;
Secure sheath hub, remove dilator and guidewire; close hemostatic valve; flush side‑port with heparinized saline;
Insert interventional devices through hemostatic valve for diagnosis or therapy;
At procedure completion, withdraw sheath gently, compress puncture site for hemostasis and apply compression dressing.
6、适应症 Indications
中文：用于经皮穿刺介入血管系统，导入球囊导管、电极、各类导管，实施血管介入诊断或治疗手术。 English：For percutaneous vascular access, to introduce balloon catheters, electrodes and various catheters for endovascular diagnostic and interventional procedures。
7、禁忌症 Contraindications
中文
穿刺部位存在活动性感染、皮肤破溃；
目标血管严重闭塞、血栓、血管畸形不适合穿刺入路；
患者存在严重凝血功能障碍，无法耐受血管穿刺；
对产品组件材质过敏者；
血管解剖结构不允许置入鞘管。
English
Active infection or skin breakdown at puncture site;
Target vessel with severe occlusion, thrombosis or malｆormation unsuitable for access;
Severe coagulopathy intolerant to vascular puncture;
Known allergy to device materials;
Vascular anatomy prohibits sheath placement.
8、注意事项 Precautions
中文
本产品一次性使用，严禁重复使用，重复使用会造成感染、器械断裂风险；包装破损、过期禁止使用；
全程无菌操作，术中透视确认鞘管位置，禁止暴力推送；遇阻力不可强行推进，防止血管撕裂、鞘管断裂；
选择鞘管规格应匹配所用介入器械最大外径，防止卡压损伤器械或鞘管；
术中持续关注患者生命体征，警惕出血、血肿、血管损伤、血栓、空气栓塞等并发症；
鞘管置入后需肝素盐水冲洗，预防管腔内血栓形成；
拔出鞘管后充分压迫穿刺点，观察有无出血、血肿；
仅由经过血管介入培训医师操作；
不可用于冠状动脉、脑血管介入场景（该型号设计用途）。
English
Single‑use only. Reuse may lead to infection or device fracture. Do not use if package damaged or expired;
Strict aseptic technique; confirm sheath position under fluoroscopy. Never advance against resistance to avoid vessel laceration or sheath breakage;
Select sheath size matching maximum outer diameter of interventional devices to prevent jamming or damage;
Continuously monitor patient vital signs; watch for complications such as bleeding, hematoma, vessel injury, thrombosis and air embolism;
Flush sheath with heparinized saline after placement to prevent intraluminal thrombus;
Adequate manual compression after sheath removal; monitor for bleeding and hematoma;
To be used only by physicians trained in endovascular intervention;
Not intended for coronary or cerebral vasculature accessFDA Access...。
9、存储条件 Storage Conditions
中文：存储于阴凉干燥环境，避免阳光直射、高温、潮湿；远离腐蚀性气体；避免挤压、弯折包装；环境温度 5‑30℃；相对湿度 30%‑75%；按货架有效期管理，有效期 3 年。 English：Store in cool and dry place, avoid direct sunlight, high temperature and humidity; keep away from corrosive gas; prevent package squeezing or bending. Ambient temperature 5‑30℃, relative humidity 30%‑75%. Observe 3‑year shelf‑life.
10、说明书核心摘要 Core Summary
中文：库克 RCFN‑5.0‑18‑MPIS‑NT 为 5F、18cm 长度一次性经皮血管鞘套装，用于建立外周血管介入通路，为导管、球囊、电极等器械提供进出通道；EO 灭菌，一次性使用；操作需 Seldinger 穿刺技术，全程透视监护；警惕血管损伤、出血、血栓并发症；包装破损过期禁用；阴凉干燥保存，有效期 3 年；外周血管，不用于冠脉、脑血管通路。 English：Cook RCFN‑5.0‑18‑MPIS‑NT is 5F/18cm single‑use percutaneous introducer sheath set for peripheral vascular access, facilitating delivery of catheters, balloons and electrodes. EO sterilized, single‑use. Adopt Seldinger technique with fluoroscopic monitoring. Watch for vascular injury, bleeding and thrombosis. Prohibit use with damaged or expired package. Store in cool‑dry environment, shelf‑life 3 years. For peripheral vasculature only, not for coronary or cerebral access.
免责声明：以上产品详情仅供参考，临床操作请以原厂纸质说明书为准。上海康世达医疗器械有限公司不生产医疗产品，所有产品均来自产品的生产厂家，代理商，经销商，如有侵权请联系我们，会尽快处理！The above product details are for reference only. All clinical operations shall be carried out in strict accordance with the original paper instructions for use issued by the manufacturer.
Shanghai Kangshida Medical Devices Co., Ltd. does not manufacture medical devices. All products are sourced from respective manufacturers, authorized agents and distributors.
Please contact us promptly in case of any infringement, and we will resolve the matter as soon as possible.
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