当前位置： 阿仪网 > 医疗器械 > 电子仪器 > 其他 > 上海康世达医疗器械有限公司 > 产品展示 > 耗材 > 厂商费森尤斯一次性使用膜式氧合器套包XLung kit, XLung kit 230
厂商费森尤斯一次性使用膜式氧合器套包XLung kit, XLung kit 230
价格：￥ 电议
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20213100136更新时间：2026/10/19 9:40:51
支付方式：
- 支付宝 微信 银行转账
产品完善度： 访问次数：352
企业档案
会员类型：旗舰版
已获得阿仪网信誉 等级评定
(0 -40)基础信誉积累，可浏览访问
(41-90)良好信誉积累，可接洽商谈
(91+ )优质信誉积累，可持续信赖
阿仪网旗舰版会员：1年
工商认证 【已认证】
最后认证时间：
注册号： 【已认证】
法人代表： 【已认证】
参观次数：139133
手机网站：http://wap.app17.com/c174616/
旗舰版网址：http://ksdy.app17.com
详细内容
厂商费森尤斯一次性使用膜式氧合器套包XLung kit, XLung kit 230
桂经理19117326863微xin同号
管理类别
第三类
型号规格
XLung kit， XLung kit 230
结构及组成/主要组成成分
本产品由氧合器及血液管路套件（含泵头）、预充套装（预充袋及管路）和气体管路组成。
适用范围/预期用途
该产品预期可用于6小时以上的体外循环方式进行血液的氧合及二氧化碳的排除，以支持呼吸和/或循环功能，最长可提供9天的体外循环支持。该产品适用于急性呼吸衰竭或急性心肺功能衰竭、其他治疗方法难以控制并有可预见的病情持续恶化或死亡风险的成人患者。
一、工作原理（Working Principle）
中文
基于中空纤维膜气体交换 + 热交换 + 密闭体外循环原理：
膜式气体交换
血液在聚丙烯中空纤维膜（外径≤200µm） 外流动，氧气 / 混合气在纤维内流动。
O₂通过半透膜弥散入血，CO₂反向弥散排出，血气不直接接触，减少溶血、微栓、炎症。
一体化热交换
血液流经不锈钢 / 钛合金热交换器，外接变温水箱调控36–38℃，维持体温稳定。
密闭循环安全
全程无菌密闭管路，含动脉 / 静脉气泡捕获器、超声监测、防反流阀、压力监测。
离心泵驱动血流（1–7L/min），低剪切力、减少血细胞破坏，支持 **≥14 天 ** 长时 ECMO。
模式适配
自动适配 VV（呼吸支持）、VA（心肺联合支持） 模式，满足重症呼吸 / 循环衰竭。
English
Based on hollow-fiber membrane gas exchange, integrated heat exchange & closed extracorporeal circulation:
Membrane Gas Exchange
Blood flows outside polypropylene hollow fibers (OD≤200µm); O₂/air mixture flows inside.
O₂ diffusion into blood, CO₂ out; no direct blood-gas contact, minimal hemolysis & inflammation.
Integrated Thermoregulation
Blood passes stainless steel/titanium heat exchanger; external heater/cooler controls 36–38°C.
Closed Safety Circuit
Sterile closed system with arterial/venous air traps, ultrasonic detection, check valves, pressure monitors.
Centrifugal pump (1–7L/min); low shear, minimal blood damage; supports ≥14 days ECMO.
Mode Compatibility
Auto-adapts to VV (respiratory) & VA (cardiorespiratory) support.
二、核心功能（Core Functions）
表格
中文功能 English Function
血液氧合：高效摄取 O₂，动脉血氧饱和度≥95% Oxygenation: Efficient O₂ uptake; SaO₂≥95%
CO₂清除：完全排出代谢 CO₂，纠正呼吸性酸中毒 CO₂ Removal: Complete CO₂ elimination; corrects acidosis
体温调控：36–38℃恒温，防低温 / 高热 Thermoregulation: 36–38°C control; prevents hypothermia/hyperthermia
体外循环：VV/VA 模式，支持≥14 天长时生命支持 Extracorporeal Circulation: VV/VA; ≥14 days support
气泡安全防护：双气泡捕获 + 超声检测，防空气栓塞 Air Embolism Protection: Dual traps + ultrasonic detection
压力全程监测：动 / 静 / 滤器前压力，预警堵管 / 血栓 Pressure Monitoring: Pre-pump/arterial/venous; alerts occlusion/clot
血液采样：动 / 静脉端口，血气 / 电解质 / 凝血实时监测 Sampling Ports: Arterial/venous; blood gas/coagulation tests
密闭无菌：一次性 EO 灭菌，防感染、无交叉污染 Sterile Closed System: EO-sterilized; single-use, infection-proof
低预充容量：小预充（≤270mL），减少血液稀释 Low Priming Volume: ≤270mL; minimizes hemodilution
三、产品特点（Product Features）
中文
高性能中空纤维膜（核心）
1200 万根聚丙烯中空纤维，高效交换面积≥1.8m²
双涂层（肝素 + 亲水），生物相容性优、抗血浆渗漏、抗血栓
O₂传输≥280mL/min，CO₂清除≥220mL/min，满足高代谢需求
一体化集成设计
氧合器 + 热交换器 + 管路 + 接口 + 监测全预装，即开即用
分色标识（红 = 动脉、蓝 = 静脉、白 = 气路、黄 = 废液），防错接
低阻力、低预充（XLung 230≤270mL），新生儿 / 小儿 / 成人通用
长时安全稳定
连续使用≥14 天，膜性能稳定、无渗漏、低炎症
低剪切力、低溶血（游离 Hb＜50mg/dL），保护血细胞
耐高温消毒、兼容转运，床旁 / 院内转运安全
生物安全与兼容
医用 PVC/PU/PP，无 DEHP、无乳胶、无热原
EO 灭菌、单人单次，防交叉感染
适配 Xenios Console、Maquet、Sorin 等 ECMO 主机
临床高效便捷
自动预冲、自动排气、快速装机（15 分钟）
鲁尔锁 + 安全接头，防脱落、防漏血
符合 ISO 7197、GB 12261、CE、NMPA 标准
English
High-Perｆormance Hollow Fiber (Core)
12 million polypropylene fibers; exchange area ≥1.8m²
Dual coating (heparin + hydrophilic); biocompatible, leak-resistant, antithrombotic
O₂ transfer≥280mL/min, CO₂ removal≥220mL/min for high ｍmbedbolic demand
Integrated All-In-One Design
Oxygenator + heat exchanger + tubing + ports + monitors pre-assembled
Color-coded (red=arterial, blue=venous, white=gas, yellow=effluent); error-proof
Low resistance, low prime (XLung 230≤270mL); neonatal/pediatric/adult
Long-Term Safety & Stability
≥14 days continuous use; stable perｆormance, no leakage
Low shear, low hemolysis (free Hb＜50mg/dL)
Sterilizable & transportable; safe bedside/intrahospital transfer
Biocompatible & Safe
Medical PVC/PU/PP, DEHP-free, latex-free, non-pyrogenic
Single-use, EO-sterilized
Compatible with Xenios Console, Maquet, Sorin ECMO systems
Efficient & Easy Clinical Use
Auto-prime, auto-purge, 15-min setup
Luer-lock + safety connectors; secure, leak-proof
Meets ISO 7197, GB 12261, CE, NMPA
四、技术参数（Technical Specifications）
表格
参数（中） Parameter (En) XLung kit XLung kit 230
型号 Model XLung kit XLung kit 230
类型 Type 一次性 ECMO 膜式氧合器套包 一次性 ECMO 膜式氧合器套包
膜材质 Membrane 聚丙烯中空纤维（双涂层） 聚丙烯中空纤维（双涂层）
交换面积 Exchange Area ≥1.6m² ≥1.8m²
血流量 Blood Flow 1–6L/min 1–7L/min
预充容量 Priming Volume ≤300mL ≤270mL
氧合性能 Oxygenation O₂≥250mL/min O₂≥280mL/min
CO₂清除 CO₂ Removal ≥200mL/min ≥220mL/min
热交换 Heat Exchanger 不锈钢，效率≥90% 钛合金，效率≥95%
温度范围 Temp Range 36–38℃ 36–38℃
压力监测 Pressure -300~+500mmHg -300~+500mmHg
气泡检测 Air Detection 超声，≤0.1mL 超声，≤0.05mL
管路材质 Tubing 医用 PVC（TOTM） 医用 PU（无 DEHP）
适用模式 Therapy VV-ECMO / VA-ECMO VV-ECMO / VA-ECMO
连续使用 Continuous Use ≤14 天 ≤14 天
灭菌 Sterilization 环氧乙烷（EO） 环氧乙烷（EO）
有效期 Shelf Life 3 年 3 年
注册证 Reg No. 国械注进 20223100369 国械注进 20223100370
包装 Pack 1 套 / 无菌袋 1 套 / 无菌袋
五、使用方法（Usage Instructions）
中文
1. 术前准备
核对型号、有效期、包装完好、无菌
ECMO 主机自检，连接变温水箱（37℃）、气源（O₂/ 空气）
准备插管（动 / 静脉）、预充液（生理盐水 / 白蛋白）、抗凝（肝素）
自动预冲（500–1000mL），排气、检漏、压力校准
2. 套包安装
开封套包，按颜色标识连接 ECMO 主机接口
氧合器 / 热交换器固定于支架，管路无扭曲、无受压
动脉 / 静脉管路接离心泵、气泡监测、压力传感器
连接气源（O₂ 1–6L/min，FiO₂ 0.4–1.0）、变温水管
3. 患者连接
无菌操作下置入动 / 静脉插管，与套包鲁尔锁连接
启动低流量（1–2L/min），检查漏血、气泡、压力
逐步调至目标流量（3–7L/min），监测SaO₂≥95%、SvO₂≥65%
启动抗凝（肝素 20–50U/kg/h），监测 ACT（180–220s）
4. 治疗监测
持续监测：流量、压力、气泡、温度、血气、ACT、凝血
每 30 分钟记录：参数、出入量、生命体征、氧合指标
报警：立即停泵→排查→处理→重启，严禁屏蔽
5. 结束与处置
撤离：逐步降流量→停泵→夹闭管路→分离患者
套包一次性废弃（感染性医疗废物）
设备清洁消毒，记录存档
English
1. Pre-Treatment
Verify model, expiry, sterile package
ECMO console self-test; connect heater/cooler (37°C), gas supply (O₂/air)
Prepare cannulae, prime (saline/albumin), heparin
Auto-prime (500–1000mL); purge, leak-test, calibrate pressures
2. Kit Installation
Open kit; connect color-coded lines to console
Secure oxygenator/heat exchanger; no kinks
Connect arterial/venous lines to pump, air detector, pressure sensors
Attach gas (O₂ 1–6L/min, FiO₂ 0.4–1.0) & heater/cooler lines
3. Patient Connection
Aseptically insert arterial/venous cannulae; lock to kit
Start low flow (1–2L/min); check leaks, air, pressures
Gradually increase to target (3–7L/min); confirm SaO₂≥95%, SvO₂≥65%
Initiate heparin (20–50U/kg/h); maintain ACT 180–220s
4. Treatment Monitoring
Continuous surveillance: flow, pressure, air, temp, blood gas, ACT
Document q30min: parameters, I&O, VS, oxygenation
Alarms: stop pump → fix → restart; no bypass
5. Termination & Disposal
Wean: reduce flow → stop pump → clamp lines → disconnect
Single-use disposal (infectious waste)
Clean/disinfect console; document
六、适应症（Indications）
中文
急性呼吸窘迫综合征（ARDS）：重症肺炎、新冠、吸入性损伤、难治性低氧血症
急性呼吸衰竭：肺栓塞、重症哮喘、肺挫伤、间质性肺病
心源性休克 / 心脏骤停：心梗、心肌炎、心肌病、心脏术后低心排
体外循环支持：心脏手术、肺移植、ECMO 转手术过渡
严重感染 / 脓毒症：感染性休克、多器官衰竭（MOF）伴呼吸 / 循环衰竭
肺栓塞：大面积 / 次大面积肺栓塞，血流动力学不稳定
新生儿 / 小儿呼吸衰竭：胎粪吸入、肺发育不良、顽固性低氧
其他：溺水、烧伤、创伤、中毒致严重呼吸 / 循环衰竭
English
ARDS: Severe pneumonia, COVID-19, inhalation injury, refractory hypoxemia
Acute Respiratory Failure: Pulmonary embolism, severe asthma, lung contusion
Cardiogenic Shock / Cardiac Arrest: MI, myocarditis, cardiomyopathy, post-cardiotomy
Cardiopulmonary Bypass Support: Cardiac surgery, lung transplant, bridge to surgery
Sepsis / Septic Shock: Multi-organ failure (MOF) with cardiorespiratory collapse
Massive Pulmonary Embolism: Hemodynamically unstable
Pediatric/Neonatal Respiratory Failure: Meconium aspiration, lung hypoplasia
Other: Drowning, burns, trauma, intoxication with cardiorespiratory failure
七、禁忌症（Contraindications）
中文
绝对禁忌
不可逆脑死亡、颅内出血未控制、严重中枢损伤
晚期恶性肿瘤、预期寿命＜24 小时、多器官衰竭终末期
严重凝血障碍、DIC、无法抗凝、活动性大出血
血管条件极差、无法建立有效 ECMO 血管通路
患者 / 家属明确拒绝ECMO 生命支持
对套包材质（PVC/PU/PP/ 肝素）严重过敏
相对禁忌（慎用）
年龄＞80 岁、体重＜2kg、极低体重儿
严重贫血（Hb＜50g/L）、血小板＜10×10⁹/L
未控制的感染、免疫缺陷、活动性肝炎 / 结核
妊娠晚期、严重腹腔高压
精神异常、不配合、长期卧床无法耐受
English
Absolute
Irreversible brain death, uncontrolled intracranial hemorrhage
Terminal malignancy, life expectancy＜24h, end-stage MOF
Severe coagulopathy, DIC, uncontrolled bleeding
Unobtainable ECMO vascular access
Patient/family refusal
Severe allergy to PVC/PU/PP/heparin
Relative (Caution)
Age＞80y, weight＜2kg, extremely low birth weight
Anemia (Hb＜50g/L), platelets＜10×10⁹/L
Uncontrolled infection, immunodeficiency
Late pregnancy, severe abdominal hypertension
Psychosis, uncooperative, unable to tolerate
八、注意事项（Precautions）
中文
专业操作：ECMO 持证团队（心外 / ICU / 麻醉），严格无菌 SOP
术前核查：包装破损、过期、污染严禁使用
套包匹配：专用 XLung 套包，不可混用其他机型
安装规范：颜色对应、管路通畅、无扭曲、无气泡、热交换到位
安全监测：持续开启压力、气泡、流量、温度、血气监测
抗凝管理：肝素 / 枸橼酸，监测 ACT/APTT/Ca²⁺，防出血 / 血栓
容量控制：严格出入平衡，防容量过载 / 不足、心衰 / 休克
管路维护：防扭结、防受压、防脱落，固定稳妥；堵管严禁暴力通管
感染防控：无菌操作、每日换药、管路密闭、抗生素预防
并发症防控
空气栓塞：预冲、防脱落、气泡监测
出血 / 血栓：适度抗凝、压力监测、流量稳定
溶血 / 贫血：低流量、低剪切、监测游离 Hb
感染：无菌、密闭、每日护理
低温：必须热交换，维持 36–37℃
记录完整：模式、参数、流量、压力、血气、抗凝、并发症、操作者
English
Professional Use: Only ECMO-certified teams (CTS/ICU/Anesthesia), strict asepsis/SOP
Pre-Check: Do not use if damaged/expired
Compatibility: XLung-specific only; no cross-use
Correct Setup: Color-match, patent lines, no kinks/air, heater secure
Continuous Monitoring: Pressure, air, flow, temp, blood gas—no bypass
Anticoagulation: Titrated heparin/citrate; monitor ACT/APTT/Ca²⁺
Volume Balance: Strict I&O control; avoid overload/hypovolemia
Line Care: Prevent kinks/pressure/dislodgement; occlusion—no forceful manipulation
Infection Control: Asepsis, daily dressing, closed system, prophylaxis
Complication Prevention
Air Embolism: Thorough priming, secure connections
Bleeding/Clotting: Appropriate anticoagulation
Hemolysis: Low flow, low shear, monitor free Hb
Infection: Aseptic technique, closed system
Hypothermia: Mandatory heating; 36–37°C
Documentation: Mode, parameters, flow, pressure, blood gas, anticoagulation, events
九、存储条件（Storage Conditions）
中文
未开封
温度：15–30℃，避免 **＜5℃或＞40℃**
湿度：30–70%RH，无冷凝、无潮湿
环境：干燥、通风、避光、防尘、防腐蚀、防挤压 / 锐器
禁止冷冻、阳光直射、高温、潮湿、放射性、电磁干扰
运输
温度：-10℃～40℃，防剧烈震动、摔落、雨淋
使用前
室温平衡30 分钟再开封，防材料脆裂、漏液
English
Unopened
Temp: 15–30°C; avoid <5°C or >40°C
Humidity: 30–70%RH, non-condensing
Environment: Dry, ventilated, dark, dust/corrosion/crush-proof
No freezing, sun, heat, moisture, radiation, EMI
Shipping
Temp: -10°C～40°C; shock/drop/rain protection
Pre-Use
Equilibrate 30 mins at room temp; prevent cracking/leaks
十、说明书核心信息（Manual Key Inｆormation）
中文
产品标识：名称、XLung kit / 230、注册证 20223100369/370、批号、灭菌 / 失效日期、厂家（Xenios AG）
组成：膜式氧合器、热交换器、动脉 / 静脉管路、气泡捕获器、压力监测口、采样口、鲁尔锁接头、安全夹、气源接口、变温水管、固定支架
适用范围：≥2kg 患者，用于 VV-ECMO（呼吸）、VA-ECMO（心肺）≤14 天生命支持
操作核心：分色连接、自动预冲、37℃恒温、超声气泡监测、双抗凝、14 天长时支持
安全警告：防过敏、空气栓塞、出血、血栓、溶血、感染、低温；严禁非专业操作、复用、混用
维护要求：无菌操作、管路固定、规范抗凝、持续监测、及时更换
废弃处理：一次性使用，按感染性医疗废物处置
责任声明：专业团队使用；未按说明书操作致不良事件，使用者担责；产品破损 / 过期严禁使用
English
Labeling: Name, XLung kit / 230, Reg No. 20223100369/370, Lot, Expiry, Xenios AG
Components: Membrane oxygenator, heat exchanger, arterial/venous lines, air traps, pressure ports, sampling ports, Luer-lock, clamps, gas connector, heater/cooler lines, mount
Intended Use: For ≥2kg patients; VV/VA-ECMO up to 14 days
Critical Steps: Color-coded connection, auto-prime, 37°C heating, ultrasonic air detection, dual anticoagulation, 14-day support
Warnings: Risk of allergy, air embolism, bleeding, clotting, hemolysis, infection, hypothermia; no unqualified use/reuse/cross-use
Care: Asepsis, secure lines, proper anticoagulation, continuous monitoring, prompt replacement
Disposal: Single-use; discard as infectious waste
Liability: For professional use only; user liable for improper use; do not use if damaged/expired
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.
热门标签：厂商费森尤斯一次性使用膜式氧合器套包XLung,kit,XLung,kit,230,费森尤斯膜式氧合器,费森尤斯一次性使用膜式氧合器套包
