厂家直供COOK库克导丝AWG2-35-450
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厂家直供COOK库克导丝AWG2-35-450
桂经理19117326863微xin同号
桂经理19117326863微xin同号
产品名称 导丝Acrobat® 2 Calibrated Tip Wire Guide
管理类别 第二类
型号规格 AWG2-25-260、AWG2-25-450、AWG2-35-205、AWG2-35-260、AWG2-35-450、AWG2-25-260-A、AWG2-25-450-A、AWG2-35-205-A、AWG2-35-260-A、AWG2-35-450-A
结构及组成/主要组成成分 该产品由芯丝、绕丝、覆膜、亲水涂层和激光标记组成。其中弯头导丝配有扭控手柄。产品经环氧乙烷灭菌，一次性使用。产品货架有效期3年。
适用范围/预期用途 该产品用于辅助胆管和胰管插管，并辅助在ERCP期间桥接困难狭窄段。
1、工作原理 Working Principle
中文 本导丝为镍钛合金芯轴结构，头端带不透射线标定标记，亲水涂层遇水润滑；在 X 线透视监视下，借助导丝的扭控推送性能，越过胆道 / 胰管狭窄、迂曲腔道，建立通路；标定头端可在透视下直接读取病变长度，为后续器械选择提供参考；导丝作为轨道，引导导管、扩张器、支架等内镜器械送达目标位置。
English This guide wire adopts nitinol mandrel structure with radiopaque calibrated markers on tip. Its hydrophilic coating becomes lubricious upon contact with water. Under fluoroscopy, the torque‑and‑push perｆormance enables crossing strictures and tortuous segments of biliary/pancreatic duct to establish access. Calibrated tip allows direct lesion‑length measurement under fluoroscopy for subsequent device selection. It serves as rail to deliver catheters, dilators, stents and other endoscopic instruments to target site.
2、产品功能 Function
中文
ERCP 下胰管、胆管插管，协助完成腔道超选；
通过狭窄、迂曲病变，建立器械输送轨道；
标定头端可测量病变狭窄段长度；
支持导管、取石球囊、胆道支架等器械交换与输送。
English
Assist cannulation and selective intubation of pancreatic and biliary ducts under ERCP;
Cross strictures and tortuous lesions to establish delivery rail for instruments;
Calibrated tip enables measurement of stricture length;
Support exchange and delivery of catheters, stone‑extraction balloons, biliary stents and other devices.
3、产品特点 Product Features
中文
镍钛合金芯丝，抗扭结，推送传递稳定；
远端 5.8cm 亲水涂层，湿润后摩擦阻力极低；
4cm 不透射线标定头端，带刻度标记，透视下可直接测长；
0.035 英寸外径，450cm 超长总长度，适配长操作距离 ERCP；
直头端设计，柔顺软头，降低腔道穿孔风险；
环氧乙烷灭菌，一次性使用。
English
Nitinol core for excellent kink‑resistance and stable torque transmission;
Distal 5.8 cm hydrophilic coating provides ultra‑low friction when wetted;
4 cm radiopaque calibrated tip with scale markers for direct fluoroscopic length measurement;
0.035‑inch outer diameter, total length 450 cm for long‑reach ERCP procedures;
Straight soft‑tip design to reduce risk of duct perforation;
EO sterilized, single‑use only.
4、技术参数 Technical Specifications
表格
| 中文 | English |
|---|---|
| 产品型号：AWG2‑35‑450 | Model: AWG2‑35‑450 (G47616) |
| 产品系列：Acrobat®2 Calibrated‑Tip Wire Guide | Product line: Acrobat®2 Calibrated‑Tip Wire Guide |
| 外径：0.035 英寸（0.89 mm） | Outer Diameter: 0.035 inch (0.89 mm) |
| 总长度：450 cm | Total Length: 450 cm |
| 不透射线标定头端长度：4 cm | Radiopaque calibrated tip length: 4 cm |
| 亲水涂层长度：5.8 cm | Hydrophilic coating length: 5.8 cm |
| 头端形状：直头 | Tip shape: Straight |
| 芯丝材质：镍钛合金 | Core material: Nitinol |
| 灭菌方式：环氧乙烷灭菌 | Sterilization: Ethylene‑oxide (EO) |
| 使用形式：一次性无菌，不可复用 | Usage: Single‑use sterile, non‑reusable |
| MR 兼容：未做 MR 条件测试 | MR safety: Not tested for MR environment |
5、使用方法 Method of Use
中文
打开无菌包装，取出导丝，使用无菌生理盐水充分润湿亲水涂层；
在 X 线透视监视下配合内镜操作，将导丝头端送至胆管 / 胰管开口；
轻柔推送、旋转导丝，尝试插管；遇阻力禁止暴力推送；
导丝越过狭窄段到达目标位置后，利用头端标定标记测量病变长度；
保持导丝位置固定，沿导丝导入配套导管、支架等器械完成操作；
操作完成后，透视下平稳撤出导丝；本品一次性使用，术后按医疗废弃物处理。
English
Open sterile package, take out guide wire, fully wet hydrophilic coating with sterile normal saline.
Under fluoroscopy combined with endoscopy, advance wire tip to biliary/pancreatic duct orifice.
Gently push and rotate wire for cannulation. Never advance with force when resistance is encountered.
After crossing stricture to target position, measure lesion length using calibrated tip markers.
Maintain wire position, advance compatible catheters, stents or other instruments over the wire.
Upon completion, withdraw wire smoothly under fluoroscopy. For single‑use; dispose as medical waste after procedure.
6、适应症 Indications
中文 本导丝适用于 ERCP 内镜操作中，辅助胆管、胰管插管；协助通过胆道、胰管的狭窄病变；标定头端用于测量狭窄病变长度；为导管、支架、扩张球囊等器械提供输送轨道。
English Intended for use during ERCP procedures to assist cannulation of biliary and pancreatic ducts, facilitate crossing biliary and pancreatic strictures. The calibrated tip is used for stricture‑length measurement. It provides rail for delivery of catheters, stents, dilation balloons and other instruments.
7、禁忌症 Contraindications
中文
患者存在内镜 ERCP 操作禁忌，无法行十二指肠镜置入；
胆道 / 胰管完全闭塞，导丝无安全通过路径；
已知对产品材料（镍钛合金、亲水涂层高分子）过敏；
不适用血管内使用。
English
Patients with contraindications to ERCP and duodenoscope placement.
Complete obliteration of biliary / pancreatic duct with safe passage unavailable.
Known hypersensitivity to device materials (nitinol, hydrophilic‑coating polymer).
Not intended for intravascular use.
8、注意事项 Precautions / Warnings
中文
必须在 X 线透视全程监视下操作；无透视禁止推送导丝。
亲水涂层必须充分润湿后方可使用；干燥状态推送会损伤腔道黏膜。
遇到阻力时，严禁暴力推送、旋转，应回撤调整方向，暴力操作可致导管穿孔、出血。
仅一次性使用；严禁重复灭菌复用，复用会发生涂层失效、断裂风险。
操作前确认配套器械内径与本导丝外径（0.035"）匹配。
包装破损、过期、灭菌失效禁止使用。
导丝不可用于血管系统。
仅可由经过 ERCP 专科培训医师操作。
English
Manipulation must be perｆormed under continuous fluoroscopic monitoring. Never advance without fluoroscopy.
Hydrophilic coating must be fully wetted before use. Dry advancement may injure ductal mucosa.
If resistance occurs, do NOT push or rotate forcefully. Withdraw and re‑orient. Forceful manipulation may lead to duct perforation and hemorrhage.
Single‑use only. Do not re‑sterilize or reuse; reuse risks coating failure and wire fracture.
Verify inner lumen of compatible instruments matches wire outer diameter (0.035") before use.
Do not use if package is damaged, expired or sterility compromised.
Device is not for intravascular application.
Should only be operated by physicians with specialized ERCP training.
9、存储条件 Storage Conditions
中文
存储环境温度：15‑30℃，避免高温、冷冻；
置于干燥通风处，避光，远离潮湿；
原包装存放，不可挤压、弯折包装；
有效期见产品标签，过期禁止使用。
English
Storage temperature: 15‑30℃. Avoid high‑temperature and freezing environment.
Store in dry, ventilated place away from direct sunlight and moisture.
Keep in original package. Prevent squeezing and bending of package.
Observe expiry date marked on label; do not use expired product.
10、说明书核心摘要 IFU Core Summary
中文 Acrobat2 AWG2‑35‑450 为 ERCP 专用标定型亲水导丝，0.035 英寸，总长 450cm，4cm 带刻度不透射线头端，远端 5.8cm 亲水涂层；用于胰胆管插管、过狭窄、测量病变长度、器械交换；环氧乙烷灭菌一次性使用；全程透视操作，充分润湿涂层，遇阻力禁止暴力推送，禁止血管内使用，禁止重复使用。
English Acrobat2 AWG2‑35‑450 is calibrated‑tip hydrophilic guide wire dedicated for ERCP. 0.035 inch OD, total length 450 cm, 4 cm scaled radiopaque tip, distal 5.8 cm hydrophilic coating. Indicated for biliary‑pancreatic cannulation, stricture crossing, lesion‑length measurement and instrument exchange. EO‑sterilized single‑use device. Always operate under fluoroscopy. Fully wet coating prior to use. Do not advance forcefully against resistance. Not for vascular use. Reuse is prohibited.
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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