厂商直供麦瑞通造影导丝IIQA509,IQA510,IQA511
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厂商直供麦瑞通造影导丝IIQA509,IQA510,IQA511
桂经理19117326863微xin同号
桂经理19117326863微xin同号
管理类别
第二类
型号规格
IQA509；IQA510；IQA511；IQA512；IQA513；IQA528；IQA518；IQA521；IQA522；IQA527；IQA524；IQA517；IQA519；IQA520；IQA523；IQA525；IQA526；IQA563；IQA564；IQA500；IQA501；IQA502；IQA503；IQA504。
结构及组成/主要组成成分
该产品由带聚四氟乙烯（PTFE）涂层的绕丝和芯丝组成。芯丝和绕丝的材料为304V不锈钢。产品经环氧乙烷灭菌，一次性使用。货架有效期3年。
适用范围/预期用途
该产品用于外周血管系统在诊断及介入手术期间有助于装置的放置。
1 工作原理 Working Principle
中文： 该导丝由不锈钢芯丝与外层扁形绕丝构成主体结构，远端为柔性渐缩过渡头端；在 DSA 透视显影下经皮穿刺送入外周血管腔内，充当介入器械的轨道。依靠芯丝提供推送力、抗弯折支撑力；PTFE 涂层降低血管腔内摩擦阻力；柔性伤头端降低血管内壁损伤，引导导管、球囊、支架等器械沿导丝轨道抵达目标血管部位，完成器械置入与交换操作Merit Medi...。
English： This guide wire consists of stainless‑steel inner core and flat outer coil, with a flexible tapered distal tip. Under DSA fluoroscopy, it is percutaneously advanced into peripheral vasculature and acts as a rail for interventional devices. The inner core provides push‑ability and kink‑resistant support. PTFE coating reduces intravascular friction. The atraumatic flexible tip minimizes vessel trauma, guiding catheters, balloons, stents and other devices along the wire rail to target vessels for device placement and exchangeMerit Medi...。
2 功能 Function
中文
为外周血管诊断、介入手术提供器械输送轨道，引导导管、扩张球囊、支架导管等器械到位；
提供较强杆身支撑力，满足对侧入路操作时导管交换、器械推送；
PTFE 低摩擦涂层，降低器械过导丝阻力；
透视下显影，便于术中确认导丝位置；
头端柔软，降低迂曲血管穿行过程的血管损伤风险。
English
Serve as delivery rail for devices in peripheral vascular diagnostic and interventional procedures, guiding catheters, dilatation balloons, stent catheters to target site.
Deliver enhanced shaft support for catheter exchange and device advancement during contralateral access.
Proprietary PTFE low‑friction coating reduces resistance when passing devices over wire.
Radiopaque under fluoroscopy for intra‑procedural position confirmation.
Soft distal tip reduces vessel injury while negotiating tortuous vasculature。
3 产品特点 Product Features
中文
加强型硬杆身结构：扁形外层绕丝可配置更大直径芯丝，杆身刚性强、推送性能佳，头端保留柔性，兼顾支撑与安全；
原厂 PTFE 全覆盖涂层，全段低摩擦；
伤渐缩过渡头端，杆身‑头端平滑过渡，可通过解剖复杂、迂曲外周血管；
兼容 0.035"、0.038" 规格介入器械；
远端 1cm 直短头端构型；
高不透射线性能，透视可视性好；
环氧乙烷灭菌，一次性无菌使用Merit Medi...。
English
Reinforced stiff‑shaft construction: flat outer coil allows larger‑diameter inner core for superior shaft stiffness and push‑ability, while preserving distal‑tip flexibility to balance support and safety.
Full‑length proprietary PTFE coating for low friction along entire wire.
Atraumatic tapered tip with smooth shaft‑to‑tip transition, facilitating navigation through complex, tortuous peripheral anatomy.
Compatible with 0.035" and 0.038" interventional devices.
1 cm straight short distal‑tip configuration.
High radiopacity for good fluoroscopic visualization.
Ethylene‑oxide sterilized, single‑use sterile deviceMerit Medi...。
4 技术参数 Technical Specifications
表格
| 型号 | IQA509 | IQA510 | IQA511 |
|---|---|---|---|
| 导丝直径 | 0.035"（0.89 mm） | 0.038"（0.97 mm） | 0.035"（0.89 mm） |
| 总长度 | 260 cm | 260 cm | 180 cm |
| 头端类型 | 直短头 Straight Short Tip | 直短头 Straight Short Tip | 直短头 Straight Short Tip |
| 柔性头端长度 | 1.0 cm | 1.0 cm | 1.0 cm |
| 兼容器械规格 | 0.035" | 0.038" | 0.035" |
| 灭菌方式 | 环氧乙烷 EO | 环氧乙烷 EO | 环氧乙烷 EO |
| 使用性质 | 一次性使用 Single‑use | 一次性使用 Single‑use | 一次性使用 Single‑use |
| 货架有效期 | 3 年 3‑year shelf‑life | 3 年 3‑year shelf‑life | 3 年 3‑year shelf‑life |
中文参数说明：
结构：304V 不锈钢芯丝 + 扁形外层绕丝，PTFE 涂层；
适用器械：0.035 / 0.038 英寸导管、球囊、支架输送系统；
不透射线：不锈钢绕丝实现 X 线下显影Merit Medi...。
English Specification Deｓcription
Construction: 304V stainless‑steel inner core, flat outer coil, PTFE coating.
Device compatibility: 0.035 / 0.038 inch catheters, balloons, stent delivery systems.
Radiopacity: radiopaque stainless‑steel coil for X‑ray visualizationMerit Medi...。
5 使用方法 Instructions for Use
中文
使用前核查包装完整性、灭菌有效期，包装破损 / 过期禁止使用；
在无菌操作条件下打开无菌包装取出导丝；
配合血管穿刺鞘，在 DSA 透视全程监视下，将导丝柔性头端送入血管；
透视下轻柔推送、旋转导丝，使导丝到达目标外周血管段；操作避免暴力推送，防止血管穿孔、夹层；
沿导丝送入导管、球囊、支架等介入器械，完成器械到位、交换操作；
全程透视确认导丝位置，手术完成后轻柔撤出导丝；
本品为一次性，严禁重复使用、重复灭菌；
仅由经过外周血管介入专业培训医师操作Merit Medi...。
English
Inspect package integrity and sterilization expiry before use. Do not use if package is damaged or expired.
Open sterile packaging under aseptic technique and retrieve guide wire.
With vascular access sheath in place, advance flexible wire tip into vessel under continuous DSA fluoroscopic monitoring.
Gently advance and rotate wire under fluoroscopy to position within target peripheral vessel. Avoid forceful manipulation to prevent vessel perforation or dissection.
Advance catheters, balloons, stents or other interventional devices over the positioned guide wire for device placement and exchange.
Confirm wire position by fluoroscopy throughout procedure; carefully withdraw wire upon completion.
Single‑use only. Do not re‑use or re‑sterilize.
To be operated only by physicians specially trained in peripheral vascular interventionMerit Medi...。
6 适应症 Indications
中文：适用于外周血管系统，在血管诊断及介入手术过程中辅助导管及其他介入器械的放置与交换。
English：Intended for use within the peripheral vasculature, to facilitate placement and exchange of catheters and other interventional devices during diagnostic and interventional vascular procedures。
7 禁忌症 Contraindications
中文
禁止用于冠状动脉血管、颅内脑血管系统；
不可用于本说明书规定以外血管解剖部位；
已知对产品材质（304V 不锈钢、PTFE）过敏患者禁用；
不适合经导丝无法安全通过的严重闭塞、血管破裂等病变场景Merit Medi...。
English
Contraindicated for coronary vasculature and intracerebral / cerebral vasculature.
Shall not be used in vascular anatomies outside intended peripheral‑vessel scope.
Contraindicated for patients with known hypersensitivity to device materials (304V stainless‑steel, PTFE).
Not indicated for lesions where safe wire passage cannot be achievedMerit Medi...。
8 注意事项 Warnings & Precautions
中文
仅一次性无菌使用；重复使用会造成感染、导丝断裂、涂层脱落、血管损伤风险；禁止复消；
全程必须 DSA 透视监控，严禁盲操作；
禁止暴力推送、扭转导丝，防止导丝折断、血管夹层、穿孔；
若出现推送阻力，立即停止，透视排查原因，不可强行推进；
头端不可在鞘、导管尖锐边缘反复弯折，避免导丝断裂；
使用前检查导丝外观，存在扭结、弯折、涂层破损禁止使用；
仅用于外周血管，严禁冠脉、脑血管；
操作环境应具备血管介入急救设备，处理血管损伤、栓塞等潜在并发症；
导丝不得留置体内；术后完全取出；
若包装破损、受潮、灭菌失效禁止使用Merit Medi...。
English
Single‑use sterile device only. Re‑use may cause infection, wire fracture, coating delamination and vessel trauma. Re‑sterilization is prohibited.
All manipulations must be perｆormed under continuous DSA fluoroscopy; blind manipulation is forbidden.
Do not forcefully advance or torque the wire to prevent wire breakage, vessel dissection or perforation.
If resistance is encountered, stop manipulation immediately and evaluate under fluoroscopy; do not advance against resistance.
Avoid repeated bending of tip over sharp edges of sheath or catheter to prevent wire fracture.
Visually inspect wire prior to use. Do not deploy kinked, bent or coating‑damaged wire.
For peripheral vasculature only; coronary and cerebral usage is prohibited.
Procedure room shall be equipped with emergency interventional equipment to manage potential complications including vessel injury and embolism.
Guide wire shall not be left indwelling inside patient; fully retrieve upon completion.
Do not use if package is damaged, wet or sterilization is compromisedMerit Medi...。
9 存储条件 Storage Conditions
中文存放环境：常温、干燥、避光；远离热源；避免挤压、弯折产品外包装； 温度：5‑40℃； 防潮，不可潮湿环境存放； 按标签标注有效期管理，过期不得使用。
EnglishStorage: Store at ambient temperature in dry, dark environment; keep away from heat source. Avoid compressing or bending outer package. Temperature range: 5‑40 ℃. Protect from moisture. Observe expiry date marked on label. Do not use expired product。
10 说明书核心摘要 IFU Core Summary（中英对照）
中文产品：麦瑞通造影导丝 InQwire Amplatz Guide Wire，IQA509/IQA510/IQA511 分类：Ⅲ 类介入耗材；一次性 EO 灭菌；304V 不锈钢 + PTFE 涂层 用途：外周血管诊断与介入手术中辅助导管、器械放置交换 禁忌：禁止冠脉、脑血管使用；材质过敏禁用 操作要点：全程透视，轻柔推送，遇阻力停止；一次性，术后全部取出 储存：5‑40℃干燥避光，防挤压，按效期管理 潜在并发症：血管夹层、穿孔、导丝断裂、血栓栓塞、出血、感染。
EnglishProduct: Merit InQwire Amplatz Guide Wire, Model IQA509 / IQA510 / IQA511 Classification: Class‑III interventional device; single‑use EO‑sterilized; 304V stainless‑steel with PTFE coating. Intended use: Facilitate placement & exchange of catheters/devices in peripheral vascular diagnostic and interventional procedures. Contraindications: Coronary and cerebral vasculature use forbidden; material hypersensitivity. Key operation: Continuous fluoroscopy; gentle manipulation; stop on resistance; single‑use; complete retrieval post‑procedure. Storage: 5‑40 ℃ dry & dark; avoid compression; follow expiry date. Potential complications: Vessel dissection, perforation, wire fracture, thromboembolism, hemorrhage, infection.
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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