厂家直供麦瑞通导管鞘系统K09-12765
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厂家直供麦瑞通导管鞘系统K09-12765
桂经理19117326863微xin同号
桂经理19117326863微xin同号
管理类别
第三类
型号规格
K09-12765， K09-12766， K09-12767， K09-12768， K09-12769， K09-12770， K09-12771， K09-12745， K09-12772， K09-12773。
结构及组成/主要组成成分
该产品由注射器、压力延长管、连通板和导管鞘器械（即带三通阀的导管鞘、扩张器、导引导丝和穿刺针）组成。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
在冠状或外周血管造影时，协助经皮穿刺装置插入至静脉和/或动脉。其中注射器用于冠状或外周血管造影时注射造影剂；压力延长管在造影手术中连接连通板和传感器，作为压力传输通路；连通板是一种连接管路、导管和其他器械的装置；导管鞘器械用于协助经皮穿刺装置插入至静脉和/或动脉。
1 工作原理 Working Principle
中文经皮穿刺建立血管入路；穿刺针穿透血管壁，导入导丝，扩张器扩张皮下及血管穿刺口；导管鞘沿导丝置入血管内，鞘管建立体外‑体内的密闭通道；止血阀实现器械进出同时封堵穿刺口、维持血管止血；配套注射器、压力延长管、连通板用于造影剂注射与血管内压力传导，保障冠脉 / 外周血管造影操作实施。
EnglishEstablish percutaneous vascular access. The access needle penetrates vessel wall for guidewire introduction. The dilator enlarges subcutaneous tissue and vascular puncture orifice. The sheath cannula is advanced over guidewire into vessel lumen to ｆorm a sealed extra‑intracorporeal pathway. The hemostasis valve permits device exchange while sealing puncture site to maintain hemostasis. Attached syringe, pressure extension tubing and manifold enable contrast media injection and intravascular pressure transmission for coronary and peripheral angiographyMerit Medi...。
2 产品功能 Functions
中文
协助经皮穿刺器械进入动脉 / 静脉，建立介入操作血管通路；
为导管、导丝等各类介入器械提供进出血管的通道；
止血阀在器械插拔交换过程中维持穿刺部位止血；
配套组件实现造影剂注射、血管压力监测与管路连通，支持冠脉及外周血管造影诊断操作。
English
Assist percutaneous access devices to enter arteries / veins and establish interventional vascular pathway.
Provide working channel for catheters, guidewires and other interventional devices.
The hemostatic valve maintains puncture‑site hemostasis during device insertion, withdrawal and exchange.
Auxiliary components support contrast injection, intravascular pressure monitoring and manifold connection for coronary and peripheral angiographyMerit Medi....
3 产品特点 Product Features
中文
成套一体化系统：集成穿刺、导丝、扩张、鞘管、造影测压全套组件，开箱即可开展血管入路操作；
内置止血阀结构，器械交换时减少血液外渗；
配套三通 / 连通板、压力延长管、注射器，兼容造影与实时压力监测；
环氧乙烷灭菌，无菌独立包装，一次性使用，规避交叉感染；
鞘管及扩张器适配标准介入器械规格，兼容冠脉、外周血管介入操作场景。
English
Integrated all‑in‑one kit: complete set of puncture, guidewire, dilation, sheath, angiography & pressure‑monitoring components for immediate vascular access procedure.
Built‑in hemostatic valve reduces blood extravasation during device exchanges.
Manifold, pressure extension tubing and syringe included, compatible with angiography and real‑time pressure monitoring.
Ethylene‑oxide sterilized, sterile individual packaging, single‑use only to avoid cross‑contamination.
Sheath and dilator match standard interventional device specifications, suitable for coronary and peripheral vascular interventionsMerit Medi....
4 技术参数 Technical Specifications
公开注册文档未披露 K09‑12765 单条精确 F 值 / 鞘长，列出注册公开信息；精确尺寸请查阅产品本体标签 / 箱内 IFU。
中文
产品型号：K09‑12765
注册证编号：国械注进 20193030185
产品组成：带三通阀导管鞘、扩张器、导引导丝、穿刺针、注射器、压力延长管、连通板
灭菌方式：环氧乙烷（EO）灭菌
使用属性：一次性使用，不可重复使用、不可重复灭菌
货架有效期：3 年
管理类别：第三类医疗器械
适用术式：冠脉血管造影、外周血管造影经皮血管入路建立
English
Model No.: K09‑12765
Registration No.: 国械注进 20193030185
Components: sheathing introducer with three‑way valve, vessel dilator, guiding wire, access needle, syringe, pressure extension tubing, manifold
Sterilization: Ethylene Oxide (EO)
Usage: Single‑use only; no re‑use / re‑sterilization permitted
Shelf‑life: 3 years
Device Class: Class Ⅲ medical device
Procedures: Percutaneous vascular access for coronary angiography and peripheral angiography
5 使用方法 Method of Use
中文
打开无菌包装，检查包装、组件完整性与有效期；
常规消毒、铺巾，穿刺针经皮穿刺靶血管；回抽见血确认进入血管腔内；
通过穿刺针送入导引导丝，确认导丝位于血管腔内后撤出穿刺针；
沿导丝推送扩张器，对皮下组织与血管穿刺口进行预扩张，之后撤出扩张器；
将导管鞘（鞘 + 止血阀组件）沿导丝推送置入血管内，到位后移除导丝；
将连通板、压力延长管、注射器装配连接，完成管路排气，可进行测压、注射造影剂；
通过鞘止血阀送入导管、导丝等器械开展造影及后续介入操作；操作全程固定鞘管防止移位；
临床操作结束，缓慢撤出鞘管，穿刺部位充分压迫止血；废弃物按医疗感染性废弃物处置Merit Medi...。
English
Open sterile package; inspect package integrity, components and expiry date.
Perｆorm standard disinfection and draping. Puncture target vessel with access needle; confirm intravascular position by blood aspiration.
Advance guidewire through needle; remove access needle while keeping guidewire in vessel lumen.
Advance dilator over guidewire to pre‑dilate subcutaneous tissue and vascular puncture orifice; then remove dilator.
Advance sheath introducer assembly over guidewire into vessel lumen; remove guidewire once sheath is correctly positioned.
Assemble manifold, pressure extension tubing and syringe; purge air from tubing for pressure measurement and contrast injection.
Insert catheters, guidewires and other instruments through sheath hemostatic valve for angiography and subsequent interventions. Secure sheath against displacement throughout procedure.
Upon clinical completion, withdraw sheath slowly; apply adequate compression for hemostasis at puncture site. Dispose as bio‑hazard medical wasteMerit Medi....
6 适应症 Indications for Use
中文在冠状或外周血管造影时，协助经皮穿刺装置插入至静脉和 / 或动脉；提供介入器械进入血管的通路，配套组件用于造影剂注射与血管压力监测，用于各类诊断性血管造影操作。
EnglishTo assist percutaneous access devices for insertion into veins and/or arteries during coronary or peripheral angiography. Provides vascular entry pathway for interventional instruments. Auxiliary components are intended for contrast‑media injection and intravascular pressure monitoring for diagnostic angiographic procedures.
7 禁忌症 Contraindications
国内注册资料未列出专门逐条禁忌症；汇总原厂 IFU 通用禁忌，临床结合患者情况综合评估Merit Medi...。
中文
穿刺部位存在活动性感染、皮肤坏死；
靶血管严重闭塞、解剖畸形，无法建立经皮血管通路；
已知对产品材料（聚合物、金属组件、环氧乙烷残留）过敏；
患者存在严重凝血功能障碍，无法实施穿刺后有效压迫止血；
临床评估经皮血管入路风险大于获益者，禁止使用本入路系统。
English
Active infection or skin necrosis at intended puncture site.
Target vessel total occlusion or severe anatomical malｆormation precluding percutaneous access.
Known hypersensitivity to device materials (polymers, ｍmbedllic components, EO residues).
Severe coagulopathy where adequate post‑puncture compression hemostasis cannot be achieved.
Percutaneous vascular access judged clinically high‑risk outweighing potential benefits.
8 注意事项 Warnings & Cautions
中文
一次性使用，严禁重复使用、重复灭菌；重复使用会造成器械失效、感染、患者重伤甚至死亡风险Merit Medi...。
受过血管介入培训医师操作；
使用前核查包装无菌屏障、有效期；包装破损、过期禁止使用；
推送导丝、扩张器、鞘管遇阻力，禁止暴力推进，应透视评估解剖位置；
鞘管留置体内期间建议腔内留置导管 / 内支撑，避免鞘管瘪陷坍塌；
不可与高压注射器联用；
操作全过程透视监护，警惕血管损伤、夹层、穿孔、血栓、栓塞、出血、血肿等并发症；
器械交换时务必固定鞘管，防止鞘管移位脱出血管；
操作结束拔出鞘管后，对穿刺点进行足够时间压迫止血，密切监测出血、血肿；
所有组件不可改装切割，避免毛刺造成血管损伤Merit Medi...。
English
Single‑use only. Never re‑use or re‑sterilize. Re‑use may cause device failure, infection, serious patient injury or deathMerit Medi....
To be used only by physicians trained in endovascular interventional procedures.
Inspect sterile barrier and expiry date before use. Discard if package damaged or expired.
Do not advance guidewire, dilator or sheath against resistance; assess anatomy under fluoroscopy.
Maintain catheter or obturator inside indwelling sheath to prevent cannula collapse.
Not intended for power injector.
Continuous fluoroscopic monitoring is required. Be alert for complications: vessel injury, dissection, perforation, thrombosis, embolism, bleeding and hematoma.
Secure sheath firmly during device exchange to prevent sheath migration or dislodgement.
Adequate compression hemostasis must be applied after sheath removal; closely monitor for bleeding and hematoma.
Do not modify or cut components; burrs may cause vascular traumaMerit Medi....
9 存储条件 Storage Conditions
中文
储存环境：阴凉、干燥，避免阳光直射；远离腐蚀性气体；
温度：常温保存，避免高温、冷冻；
原包装储存，勿挤压、撞击包装；
在有效期内使用。
English
Storage environment: cool and dry; avoid direct sunlight and corrosive gas.
Temperature: store at ambient temperature; avoid excessive heat and freezing.
Keep in original packaging; prevent compression and impact.
Use within shelf‑life expiry date.
10 说明书核心信息总览 Core IFU Summary
中文
产品：导管鞘系统 K09‑12765，美国麦瑞通 Merit Medical
注册证：国械注进 20193030185；Ⅲ 类；EO 灭菌，一次性；有效期 3 年
用途：冠脉、外周血管造影手术建立经皮动 / 静脉入路；配套实现造影剂注射、压力监测
关键风险：血管夹层、穿孔、出血血肿、血栓栓塞、感染；暴力推送造成血管损伤；复用带来致命风险
操作要点：透视下操作；遇阻力禁止硬推；全程固定鞘管；拔鞘后充分压迫止血
存储：阴凉干燥避光；原包装；禁挤压；不过期使用
重要提示：本摘要仅用于文档编写、内部技术比对，临床必须阅读原厂随产品附带的 IFU 纸质说明书执行。
English
Product: Sheath Introducer System K09‑12765, Merit Medical Systems, USA
Registration: 国械注进 20193030185; Class Ⅲ; EO sterilized, single‑use; 3‑year shelf‑life
Intended use: Percutaneous arterial / venous access for coronary & peripheral angiography; support contrast injection and pressure monitoring.
Key risks: vessel dissection, perforation, bleeding‑hematoma, thromboembolism, infection; trauma from forceful advancement; fatal hazards due to re‑use.
Key procedural notes: fluoroscopy guidance; no advancement against resistance; secure sheath throughout procedure; adequate compression hemostasis post‑removal.
Storage: cool‑dry, protected from sunlight; keep original packaging; avoid compression; use before expiry.
Important note: This summary is for internal technical reference only. Clinicians must refer to original paper IFU supplied with each device for clinical practice.
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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