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厂家费森尤斯一次性使用无菌血管鞘穿刺附件包8405921,8405941,8405925
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厂家费森尤斯一次性使用无菌血管鞘穿刺附件包8405921,8405941,8405925
桂经理19117326863微xin同号
管理类别
第三类
型号规格
8405921 / 8405941 / 8405925
结构及组成/主要组成成分
该产品由穿刺针、一次性使用无菌注射器、导丝、扩张器和可撕裂导管鞘及隧道针组成，其中隧道针只适用于型号规格为8405925型。该产品为一次性使用无菌产品，经环氧乙烷灭菌，货架有效期为4年。
适用范围/预期用途
该产品是一次性使用无菌治疗装置，为经皮辅助将导管导入静脉血管的诊断或治疗器械。主要用于为医生提供一种通过微创技术（有时被称为“Seldinger技术”）辅助将导管插入静脉血管的器械。
一、工作原理（Working Principle）
中文
基于Seldinger 经皮穿刺技术，通过 "穿刺 - 导丝引导 - 扩张 - 置鞘" 四步闭环，微创建立血管通道：
血管穿刺：穿刺针经皮刺入目标血管（静脉 / 动脉），见回血确认穿刺成功。
导丝置入：经穿刺针腔送入柔软导丝至血管内，固定导丝后退出穿刺针。
通道扩张：沿导丝推入扩张器，逐级扩张皮下组织与血管穿刺口，形成平滑通道。
鞘管置入：沿导丝将可撕裂血管鞘推入血管，退出导丝与扩张器，鞘管留置形成稳定血管通路。
通路使用：经鞘管可送入导管、血液管路，完成输液、采血、CRRT / 透析、介入操作；使用后沿轴向撕裂鞘管拔除，无残留、减少血管损伤。
English
Based on the Seldinger percutaneous technique, a minimally invasive vascular access is established via four steps:
Vessel Puncture: Needle punctures target vessel; blood return confirms success.
Guidewire Insertion: Soft guidewire advanced through needle into vessel; needle withdrawn over wire.
Dilation: Dilator advances over wire to dilate subcutaneous tissue & vessel puncture site.
Sheath Placement: Peel-away sheath inserted over wire; wire & dilator removed, leaving sheath as stable access.
Usage & Removal: Catheters/lines inserted for infusion, blood draw, CRRT, or intervention; peel sheath axially upon removal to minimize vessel trauma.
二、核心功能（Core Functions）
表格
中文功能 English Function
血管通路建立：快速、微创建立中心静脉 / 外周血管通路（CRRT / 透析 / 输液） Vascular Access Creation: Fast, minimally invasive central/peripheral access (CRRT/dialysis/infusion)
导丝引导定位：导丝引导，提升穿刺成功率、降低血管后壁损伤 Guidewire Guidance: Precise wire placement, high success, low posterior wall injury
组织扩张保护：逐级扩张，减少血管撕裂、出血、血肿风险 Tissue Dilation: Graduated dilation reduces vessel tear, bleeding, hematoma
可撕裂鞘留置：鞘管提供稳定通道，使用后可撕裂拔除，无残留、创伤小 Peel-Away Sheath: Stable access; peelable removal, no residue, minimal trauma
多规格适配：8405921/8405941/8405925 不同规格，适配成人 / 儿童、不同血管 Multi-Size Compatibility: 8405921/8405941/8405925 for adult/pediatric, various vessels
全程无菌封闭：环氧乙烷灭菌，一次性使用，防交叉感染 Sterile Closed System: EO sterilized, single-use, prevents cross-infection
组件集成配套：含穿刺针、注射器、导丝、扩张器、鞘、隧道针（8405925），一站式使用 All-In-One Kit: Needle, syringe, guidewire, dilator, sheath, tunneler (8405925)
三、产品特点（Product Features）
中文
Seldinger 标准设计：经典技术，操作简便、成功率高、临床认可度强。
可撕裂鞘专利设计：轴向平滑撕裂，拔除无牵拉、血管损伤小、出血少。
导丝优化：0.035 英寸（0.89mm） 柔软 J 形头，防血管内膜损伤、推送顺畅。
扩张器渐变设计：医用聚氨酯，光滑渐变，扩张阻力小、组织损伤轻。
三型号区分
8405921：基础型，含穿刺针、导丝、扩张器、可撕裂鞘
8405941：加强型，加长鞘 / 扩张器，适配深静脉、肥胖患者
8405925：带隧道针，专用于皮下隧道式置管，防感染、延长留置
生物相容性：医用 PVC/PU/PC，无致敏、无溶血、环氧乙烷灭菌、无热原。
一次性无菌：单人单次使用，杜绝复用感染风险。
包装便捷：无菌托盘、组件有序排列，开包即用、缩短准备时间。
English
Classic Seldinger Design: Proven technique, simple, high success rate.
Peel-Away Sheath: Smooth axial peeling, atraumatic removal, minimal bleeding.
Optimized Guidewire: 0.035" (0.89mm), soft J-tip, prevents intimal injury, smooth insertion.
Tapered Dilator: Medical PU, smooth taper, low resistance, minimal tissue trauma.
Three Specialized Models
8405921: Basic set (needle, wire, dilator, peel sheath)
8405941: Extended length for deep veins/obese patients
8405925: With tunneler for subcutaneous tunneling, infection prevention
Biocompatible: Medical PVC/PU/PC, non-toxic, non-hemolytic, EO sterile, pyrogen-free.
Single-Use Sterile: One patient, one kit; no reuse risk.
Convenient Packaging: Sterile tray, organized components, ready-to-use.
四、技术参数（Technical Specifications）
表格
参数项（中文） Parameter (English) 8405921 8405941 8405925
产品型号 Model 8405921 8405941 8405925
注册证号 Reg No. 国械注进 20193030460 国械注进 20193030460 国械注进 20193030460
组件组成 Components 穿刺针、注射器、导丝、扩张器、可撕裂鞘 穿刺针、注射器、加长导丝、加长扩张器、加长可撕裂鞘 穿刺针、注射器、导丝、扩张器、可撕裂鞘、隧道针
穿刺针规格 Needle Gauge 18G×6.35cm（2.5"） 18G×6.35cm（2.5"） 18G×6.35cm（2.5"）
导丝规格 Guidewire 0.035"×45cm，J 形头 0.035"×60cm，J 形头 0.035"×45cm，J 形头
扩张器规格 Dilator 8.5Fr 10.0Fr 8.5Fr
血管鞘规格 Sheath 8.5Fr×10cm，可撕裂 10.0Fr×15cm，可撕裂 8.5Fr×10cm，可撕裂
隧道针 Tunneler - - 标配
灭菌方式 Sterilization 环氧乙烷（EO） 环氧乙烷（EO） 环氧乙烷（EO）
有效期 Shelf Life 4 年 4 年 4 年
材质 Material 医用 PU、PVC、PC、304 不锈钢 医用 PU、PVC、PC、304 不锈钢 医用 PU、PVC、PC、304 不锈钢
包装 Packaging 1 套 / 无菌托盘 1 套 / 无菌托盘 1 套 / 无菌托盘
五、使用方法（Usage Instructions）
中文
术前准备
核对型号、有效期、包装完整性，无菌开包。
患者取仰卧位，穿刺部位（颈内 / 股 / 锁骨下静脉）消毒铺巾。
局部麻醉（1% 利多卡因），用配套注射器抽吸麻醉。
血管穿刺
持穿刺针（带注射器）45° 进针，见鲜红色静脉血回流，确认穿刺成功。
固定穿刺针，经针芯送入J 形导丝至血管内 15–20cm，退出穿刺针（保留导丝）。
扩张与置鞘
沿导丝将扩张器 + 鞘管组合缓慢推入，扩张皮下与血管口。
固定鞘管，同步退出导丝与扩张器，鞘管留置血管内。
8405925：用隧道针建立皮下隧道，将鞘管经隧道引出，降低感染风险。
通路使用
连接 CRRT / 透析 / 输液管路，肝素盐水封腔（10–100U/mL）。
固定鞘管，无菌敷料覆盖，记录置入时间、部位、规格。
拔除与处置
治疗结束，沿鞘管轴向撕裂，平稳拔除，局部按压 10–15 分钟止血。
套件按感染性医疗废物规范处置。
English
Preoperative Setup
Verify model, expiry, package integrity; aseptic opening.
Patient supine; sterilize & drape access site (jugular/femoral/subclavian).
Local anesthesia (1% lidocaine) with kit syringe.
Vessel Puncture
Insert needle (with syringe) at 45°; venous blood return confirms success.
Advance J-tip guidewire 15–20cm into vessel; withdraw needle (wire remains).
Dilation & Sheath Placement
Advance dilator-sheath assembly slowly over wire to dilate tract.
Secure sheath; withdraw wire & dilator together.
8405925: Use tunneler for subcutaneous tunnel to reduce infection.
Access Usage
Connect CRRT/dialysis/infusion line; heparin lock (10–100U/mL).
Secure sheath, sterile dressing; document insertion details.
Removal & Disposal
Peel sheath axially; withdraw smoothly; hold pressure 10–15 mins.
Discard kit as infectious waste.
六、适应症（Indications）
中文
中心静脉通路：ICU 重症、CRRT / 血液透析、长期输液、肠外营养、中心静脉压监测。
急性肾损伤：multiFiltratePRO 等 CRRT 治疗血管通路建立。
血液净化：血液透析、血浆置换、吸附治疗通路。
重症治疗：休克、脓毒症、多器官衰竭、大手术术中 / 术后输液、采血。
介入诊疗：心血管 / 外周血管介入、造影、电生理检查临时通路。
特殊场景：8405925 带隧道针，用于长期留置、防感染（如透析长期导管）。
English
Central Venous Access: ICU, CRRT/dialysis, long-term infusion, TPN, CVP monitoring.
Acute Kidney Injury: Vascular access for multiFiltratePRO CRRT.
Blood Purification: Hemodialysis, TPE, adsorption therapy.
Critical Care: Shock, sepsis, MODS, intra/post-op infusion, blood sampling.
Interventional Procedures: Cardiac/peripheral angiography, EP studies.
Special Use: 8405925 with tunneler for long-term, infection-resistant access.
七、禁忌症（Contraindications）
中文
绝对禁忌
穿刺部位感染、破损、烧伤、血栓性静脉炎。
严重凝血功能障碍、血小板＜20×10⁹/L、DIC、活动性出血。
血管闭塞、狭窄、畸形、严重动脉硬化，无法穿刺。
对PU/PVC/ 不锈钢 / 环氧乙烷残留严重过敏。
患者拒绝穿刺、意识障碍无法配合。
相对禁忌
严重低血压休克（MAP＜60mmHg）、循环衰竭（慎用）。
肥胖、解剖结构不清（超声引导下可使用）。
小儿（＜3 岁）、新生儿（选小号规格，专业操作）。
穿刺部位水肿、血肿、外伤（避开损伤区域）。
English
Absolute Contraindications
Infection, burn, thrombophlebitis at access site.
Severe coagulopathy, platelets <20×10⁹/L, DIC, active bleeding.
Vessel occlusion, stenosis, anomaly, severe arteriosclerosis.
Severe allergy to PU/PVC/stainless steel/EO residue.
Patient refusal, uncooperative delirium.
Relative Contraindications
Severe hypotensive shock (MAP <60mmHg), circulatory failure (caution).
Obesity, obscured anatomy (use ultrasound guidance).
Infants (<3yo), neonates (small size, expert use).
Edema, hematoma, trauma at site (avoid injured area).
八、注意事项（Precautions）
中文
专业操作：持证医师 / 护士，严格无菌、Seldinger 技术规范。
包装检查：破损、漏气、过期、湿包严禁使用。
导丝安全：J 形头朝向血管，禁止暴力推送，防血管穿孔。
扩张轻柔：沿导丝缓慢旋转推进，遇阻力停止，防血管撕裂。
鞘管固定：牢固固定，防移位、脱出、扭曲，保持通畅。
感染防控：每日换药、观察红肿 / 渗液 / 发热，留置≤7 天（隧道型≤30 天）。
出血监控：术后观察血肿、出血，凝血障碍者延长按压时间。
一次性使用：严禁复用、再灭菌，按医疗废物处置。
型号匹配：按血管、患者体型选规格（8405921/8405941/8405925）。
English
Professional Use: Only by licensed staff, strict aseptic/Seldinger technique.
Package Check: Do not use if damaged, expired, wet, or leaking.
Guidewire Safety: J-tip toward vessel; no force to avoid perforation.
Gentle Dilation: Advance slowly with rotation; stop on resistance to prevent tear.
Secure Sheath: Fix firmly to prevent dislodgement, kinking, occlusion.
Infection Control: Daily dressing change; ≤7 days (tunneled ≤30 days).
Bleeding Monitor: Observe hematoma; prolonged pressure for coagulopathy.
Single-Use: No reuse/re-sterilization; medical waste disposal.
Size Match: Select 8405921/8405941/8405925 by vessel/patient size.
九、存储条件（Storage Conditions）
中文
未开封存储
温度：15–30℃（常温），避免 <5℃ 或>40℃
湿度：≤80%RH，无冷凝、无潮湿
环境：干燥、通风、避光、防尘、防腐蚀气体、防挤压 / 锐器
运输条件
温度：-10℃～40℃，避免剧烈震动、摔落、雨淋
使用前
室温平衡 30 分钟 再开包，防止材料脆裂
English
Unopened Storage
Temp: 15–30°C; avoid <5°C or >40°C
Humidity: ≤80%RH, non-condensing
Environment: Dry, ventilated, light/dust/corrosion-proof, no crushing/sharps
Shipping
Temp: -10°C～40°C; protect from shock, dropping, rain
Pre-Use
Equilibrate to room temp 30 mins before opening to prevent cracking
十、说明书核心信息（Manual Key Inｆormation）
中文
产品标识：名称、型号（8405921/8405941/8405925）、注册证号、批号、灭菌 / 失效日期、厂家。
组成与材质：穿刺针、导丝、扩张器、可撕裂鞘、隧道针（8405925）；医用 PU/PVC/PC/ 不锈钢。
适用范围：Seldinger 法经皮血管通路，CRRT / 透析 / 重症 / 介入；8405925 带隧道针。
操作流程：准备→麻醉→穿刺→导丝→扩张→置鞘→使用→撕裂拔除→处置。
安全警告：防血管穿孔、出血、血肿、感染、过敏、导丝断裂、复用风险。
型号差异：8405921 基础、8405941 加长、8405925 带隧道针。
废弃处理：一次性使用，感染性医疗废物处置。
责任声明：专业医护使用；违规操作致不良事件，使用者担责。
English
Labeling: Name, model (8405921/8405941/8405925), Reg No., lot, sterile/expiry dates.
Components/Materials: Needle, wire, dilator, peel sheath, tunneler (8405925); medical PU/PVC/PC/SS.
Intended Use: Seldinger vascular access for CRRT/dialysis/critical care/intervention; 8405925 tunneled.
Procedure: Prep→Anesthesia→Puncture→Wire→Dilation→Sheath→Use→Peel→Dispose.
Safety Warnings: Vessel perforation, bleeding, hematoma, infection, allergy, wire break, reuse.
Model Differences: 8405921 standard, 8405941 long, 8405925 with tunneler.
Disposal: Single-use; infectious waste.
Liability: For professional use; user responsible for improper use.
Shanghai Kangshida Medical Devices Co., Ltd. is a professional company engaged in the sales of medical devices, focusing on the agency and distribution of renowned medical equipment brands from both domestic and international markets. Its core product range covers full-scenario medical devices for physical examination, diagnosis, emergency treatment, laboratory testing, ultrasound, medical analysis, life sciences, disinfection and sterilization, rehabilitation therapy, operating rooms, emergency rooms, consulting rooms and other fields. Relying on its strong product sales capacity, excellent commercial reputation and integrity-based operation philosophy, the company has won unanimous recognition and trust from medical institutions and partners.
The steady and rapid development of the company is attributed to its carefully selected high-quality product portfolio. It always takes customer needs as the core orientation and is committed to creating long-term value and practical benefits for customers. As an authorized and exclusive agent for many well-known domestic and international manufacturers, the company has established a complete supply system of medical devices with reliable quality, fully meeting the needs of clinical diagnosis and treatment.
The company always takes improving customer satisfaction as its core goal. To strictly adhere to product standards and exceed the expectations of customers and manufacturers, it regularly provides training on professional ethics and professional business skills, forging a highly competent, efficient and executive team covering business, technology and management. The team implements a 7×24-hour all-weather response mechanism to provide professional and high-quality after-sales service and technical support, efficiently solving various equipment operation and maintenance problems. At the same time, the company offers exclusive services including same-day delivery and free distribution, ｆorming a closed loop covering supply, distribution and after-sales service to fully ensure the stable supply and worry-free use of medical equipment for medical institutions.
Upholding integrity as the foundation of its business, the company selects high-quality medical devices and provides professional services for customers, helping to upgrade the quality of medical services and contributing to the high-quality development of China's medical industry.
Intellectual Property Infringement Complaint: Kangshida Medical does not manufacture medical products; all products are sourced from original manufacturers. We will promptly address any intellectual property infringement issues.The content published herein is for reference only.
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