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厂家供应费森尤斯血浆置换用管路multiFiltratePRO TPE
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品牌名称：$brandModel.Title型号： 原产地：中国大陆 医疗器械注册号(批文)：国械注进20223100504更新时间：2026/10/19 9:40:51
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厂家供应费森尤斯血浆置换用管路multiFiltratePRO TPE
桂经理19117326863微xin同号
管理类别
第三类
型号规格
multiFiltratePRO TPE
结构及组成/主要组成成分
本产品由动脉管路系统、静脉管路系统、滤过液管路系统，血浆管路及冲洗接头组成。一次性使用，经环氧乙烷灭菌。
适用范围/预期用途
本产品与连续性血液净化设备，血浆滤过器，废液袋和动静脉穿刺针配套使用，作为液体通路用于对体重40Kg以上的患者进行 TPE(治疗性血浆置换)治疗。
血浆置换用管路 multiFiltratePRO TPE
Therapeutic Plasma Exchange Tubing multiFiltratePRO TPE
一、工作原理
Working Principle中文multiFiltratePRO TPE 是专为治疗性血浆置换（TPE）设计的一次性无菌体外循环管路系统，与费森尤斯 multiFiltratePRO 设备配套使用。通过 ** 动脉管路（红色）引出患者血液，经血浆分离器将血浆与血细胞分离；分离出的致病血浆经血浆管路（白色）与滤过液管路（黄色）排出，同时通过管路系统同步补充等量新鲜冰冻血浆、白蛋白或置换液；净化后的血细胞与置换液混合后，经静脉管路（蓝色）** 回输体内。整套管路形成密闭无菌循环，配合压力监测、空气捕获、防反流等功能，实现血浆的分离、去除与置换，清除自身抗体、免疫复合物、毒素等致病物质。
英文multiFiltratePRO TPE is a sterile, single-use extracorporeal circulation tubing system designed exclusively for Therapeutic Plasma Exchange (TPE), used with Fresenius multiFiltratePRO devices. It draws blood from the patient via the arterial line (RED), separates plasma from blood cells using a plasma filter. Pathogenic plasma is removed through the plasma line (WHITE) and filtrate line (YELLOW), while equal volumes of fresh frozen plasma, albumin, or replacement fluid are simultaneously infused. Purified blood cells mixed with replacement fluid are returned via the venous line (BLUE). The closed, sterile circuit integrates pressure monitoring, air trapping, and anti-reflux features to enable precise plasma separation, removal, and exchange, eliminating pathogenic substances like autoantibodies, immune complexes, and toxins.
二、产品功能
Functions中文
构建血浆置换专用密闭无菌体外循环通路，实现血液引出、血浆分离、废液排出、置换液输注、血液回输全流程
分流：动脉 / 静脉 / 血浆 / 滤过液四路独立管路，适配单重 / 双重血浆置换模式
压力监测：配备动脉压、静脉压、跨膜压监测接口，实时监控循环安全
空气捕获：内置空气捕获室，有效排除气泡，预防空气栓塞
抗凝与补液：提供肝素输注、置换液补充专用接口，支持治疗中给药与补液
防反流保护：集成防反流阀，防止血液或置换液逆向流动
废液收集：连接废液袋，集中收集废弃血浆与滤过液
标识清晰：颜色编码管路（红 / 蓝 / 黄 / 白），动静脉区分明确，降低操作差错
英文
Establishes a closed, sterile extracorporeal circuit dedicated to TPE, enabling complete blood withdrawal, plasma separation, waste removal, replacement infusion, and blood reinfusion
Precise fluid management: Four independent lines (arterial/venous/plasma/filtrate) for single/double filtration plasmapheresis
Pressure monitoring: Integrated ports for arterial, venous, and transmembrane pressure (TMP) tracking
Air trapping: Built-in air trap chamber to eliminate air bubbles and prevent embolism
Anticoagulation & infusion: Dedicated ports for heparin and replacement fluid delivery
Anti-reflux protection: Integrated valves to prevent backflow of blood or fluids
Waste collection: Connects to effluent bags for centralized waste plasma disposal
Color-coded lines (RED/BLUE/YELLOW/WHITE) for clear arterial/venous identification
三、产品特点
Product Features中文
专用适配：专为 multiFiltratePRO 设备设计，完美匹配设备接口与治疗参数
生物相容：医用级软 PVC 材质，内壁光滑，低阻力、低凝血、低溶血风险
无菌安全：环氧乙烷灭菌，无热原、无乳胶，一次性使用，杜绝交叉感染
结构优化：四路一体化预组装，安装简便，减少连接点，降低泄漏风险
安全设计：空气捕获、防反流、压力监测、漏血检测多重安全防护
灵活适用：支持单重血浆置换（PE）、双重血浆置换（DFPP）等多种模式
低预冲量：整体预冲容量小，减轻患者血容量波动
稳定耐用：管路柔软抗折，不易扭结，保证血流持续通畅
英文
Tailored compatibility: Exclusively designed for multiFiltratePRO, perfect interface and parameter matching
Biocompatible: Medical-grade soft PVC, smooth inner wall, low resistance, coagulation, and hemolysis risk
Sterile safety: EO sterilized, pyrogen-free, latex-free, single-use to eliminate cross-infection
Optimized structure: Pre-assembled 4-line system, easy setup, fewer connections, reduced leakage risk
Safety features: Multi-ｌayer protection (air trap, anti-reflux, pressure monitoring, blood leak detection)
Flexible modes: Supports single (PE) and double filtration (DFPP) plasmapheresis
Low priming volume: Minimizes patient blood volume fluctuations
Kink-resistant: Flexible, durable tubing ensures consistent blood flow
四、技术参数
Technical Parameters中文
型号规格：multiFiltratePRO TPE
注册证号：国械注进 20223100504
管路组成：动脉管路（红）、静脉管路（蓝）、血浆管路（白）、滤过液管路（黄）、冲洗接头
材质：管路 — 医用级软 PVC；接头 —ABS、PC、PP、PTFE、硅胶等
泵管内径：动脉 / 静脉泵段 6.4mm（ID）
总长：约 2500–3000mm
最大工作压力：动脉 - 300~+300mmHg；静脉 - 100~+500mmHg
预冲容量：≤150mL
灭菌方式：环氧乙烷（EO）灭菌
无菌 / 无热原：是
含乳胶：无
使用时限：单次使用，最长≤72 小时
有效期：灭菌后 3 年
适用患者：体重≥40kg
英文
Model：multiFiltratePRO TPE
Registration：国械注进 20223100504
Components：Arterial (RED), Venous (BLUE), Plasma (WHITE), Filtrate (YELLOW) lines, flush connector
Materials：Tubing—medical-grade soft PVC; Connectors—ABS, PC, PP, PTFE, Silicone
Pump segment ID：Arterial/Venous 6.4mm
Total length：Approx. 2500–3000mm
Max working pressure：Arterial -300~+300mmHg; Venous -100~+500mmHg
Priming volume：≤150mL
Sterilization：Ethylene Oxide (EO)
Sterile/Pyrogen-free：Yes
Latex-free：Yes
Max use time：Single use, ≤72 hours
Shelf life：3 years from sterilization
Patient weight：≥40kg
五、使用方法
Instructions for Use中文
术前检查：确认包装完好、灭菌有效、在有效期内，无破损潮湿
拆包安装：无菌打开包装，按颜色标识将管路对应连接 multiFiltratePRO 设备接口
管路预冲：用生理盐水充分预冲全管路，排净空气，检查无渗漏、无扭曲
连接配件：安装血浆分离器、废液袋、置换液袋、压力监测传感器
患者连接：核对信息，按动静脉标识连接患者血管通路，启动治疗
术中监测：实时监控压力、血流速、血浆分离量、跨膜压，观察有无气泡、漏血、凝血
治疗结束：停机、夹闭管路、回血、规范断开，按医疗废物处理
使用限制：一次性使用，严禁复用、重新灭菌或拼接使用
英文
Pre-use inspection: Verify intact package, valid sterilization, and unexpired
Setup: Open aseptically; connect color-coded lines to multiFiltratePRO ports
Priming: Thoroughly prime with saline, remove all air, check for leaks/kinks
Accessory connection: Attach plasma filter, effluent bag, replacement fluid, pressure sensors
Patient connection: Confirm ID; connect to vascular access; start therapy
Monitoring: Track pressures, flows, plasma volume, TMP; watch for air, leaks, clotting
Termination: Stop machine, clamp lines, return blood, disconnect, dispose as medical waste
Restriction: Single use only; reuse, re-sterilization, splicing prohibited
六、适应症
Indications中文与费森尤斯 multiFiltratePRO 设备、血浆分离器、废液袋、动静脉针配套，用于体重≥40kg患者的治疗性血浆置换（TPE）：
自身免疫性疾病：格林 - 巴利综合征、重症肌无力、系统性红斑狼疮、类风湿关节炎
血液疾病：血栓性血小板减少性紫癜（TTP）、溶血尿毒综合征、高球蛋白血症
中毒性疾病：药物 / 毒物中毒、重金属中毒、内毒素血症
代谢性疾病：家族性高胆固醇血症、淀粉样变性
器官移植：排斥反应、移植前脱敏、抗体介导排斥治疗
英文For use with Fresenius multiFiltratePRO, plasma filter, effluent bag, and needles for Therapeutic Plasma Exchange (TPE) in patients ≥40kg:
Autoimmune diseases: Guillain-Barré, Myasthenia gravis, SLE, Rheumatoid arthritis
Hematologic disorders: TTP, HUS, Hyperglobulinemia
Intoxication: Drug/poison poisoning, heavy ｍmbedls, endotoxemia
Metabolic disorders: Familial hypercholesterolemia, Amyloidosis
Transplantation: Rejection, desensitization, antibody-mediated rejection
七、禁忌症
Contraindications中文
产品失效：包装破损、漏气、受潮、过期、灭菌失效严禁使用
材质过敏：对 PVC、ABS、PC 等管路材质过敏者禁用
体重不符：体重＜40kg 患者禁用
严重禁忌：严重凝血障碍、无法抗凝、血流动力学不稳定、严重出血倾向者慎用 / 禁用
非适应症：严禁用于血液透析、CRRT、输液等非血浆置换治疗
违规使用：复用、再灭菌、拼接、混接其他品牌管路
英文
Product failure: Do not use if damaged, leaking, damp, expired, or non-sterile
Allergy: Contraindicated in patients allergic to PVC, ABS, PC, etc.
Weight: Not for patients <40kg
Clinical instability: Severe coagulopathy, uncontrolled bleeding, hemodynamic instability (use caution/avoid)
Off-label: Prohibited for HD, CRRT, infusion, or non-TPE use
Misuse: Reuse, re-sterilization, splicing, mixing with other brands prohibited
八、注意事项
Precautions中文
专业操作：经培训医护人员在无菌透析室操作
充分排气：预冲必须排空气，严防空气栓塞
压力监控：压力传感器正确安装，异常立即处理
管路状态：治疗中严防扭曲、受压、脱落、漏血、凝血
无菌操作：全程无菌，避免污染，连接口严格消毒
容量平衡：控制血浆去除与置换液输入平衡
应急处理：备抗凝、急救药品；异常立即停机、夹闭通路
合规处置：用后按医疗废物销毁，不得回收复用
英文
Professional use: Only by trained staff in sterile dialysis units
Air removal: Complete priming critical to prevent air embolism
Pressure monitoring: Correct sensor installation; act on alarms immediately
Line integrity: Avoid kinks, pressure, disconnection, leaks, clotting
Aseptic technique: Maintain sterility; disinfect all connections
Volume balance: Precise control of plasma removal vs replacement
Emergency readiness: Have anticoagulants and emergency drugs; stop therapy on crisis
Disposal: Destroy as medical waste; no recycling
九、存储条件
Storage Conditions中文
环境：通风、干燥、清洁、无腐蚀性气体室内
温度：5℃～30℃
湿度：≤80%，无冷凝
避光：避免阳光直射、高温烘烤
防损：避免重压、摔落、尖锐物划伤
运输：防止雨淋、剧烈震动、挤压
英文
Environment: Ventilated, dry, clean, indoor, no corrosive gases
Temperature: 5℃～30℃
Humidity: ≤80%, no condensation
Light: Protect from direct sunlight and heat
Physical: Avoid heavy pressure, drops, sharp ｏbjects
Shipping: Protect from rain, severe vibration, compression
十、说明书核心信息
Manual Core Inｆormation中文
产品名称：血浆置换用管路（multiFiltratePRO TPE）
管理类别：Ⅲ 类无菌医疗器械
组成：动脉 / 静脉 / 血浆 / 滤过液管路、冲洗接头、压力监测接口、空气捕获室、防反流阀
适配设备：费森尤斯 multiFiltratePRO 连续性血液净化设备
灭菌：EO 灭菌，无菌无热原无乳胶
使用：一次性，最长 72 小时，体重≥40kg
安全警告：防空气栓塞、防漏血、防凝血、专业操作、严禁复用
有效期：3 年
处置：医疗废物销毁
英文
Name：Therapeutic Plasma Exchange Tubing (multiFiltratePRO TPE)
Class：Class III sterile medical device
Components：Arterial/Venous/Plasma/Filtrate lines, flush connector, pressure ports, air trap, anti-reflux valve
Compatibility：Fresenius multiFiltratePRO
Sterility：EO sterilized, sterile, pyrogen-free, latex-free
Use：Single use, ≤72 hours, ≥40kg patients
Warnings: Air embolism, blood leak, clotting risks; professional use only; no reuse
Shelf life: 3 years
Disposal: Medical waste destruction
Registration:
的产品工作原理中英文，功能中英文，产品特点中英文，技术参数中英文、使用方法中英文、适应症中英文、禁忌症中英文、注意事项中英文，存储条件中英文，说明书中英文核心信息
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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