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厂家费森尤斯连续性血液净化管路multiFiltrate Paed CRRT/SCUF Set
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厂家费森尤斯连续性血液净化管路multiFiltrate Paed CRRT/SCUF Set
桂经理19117326863微xin同号
管理类别
第三类
型号规格
multiFiltrate Paed CRRT/SCUF Set
结构及组成/主要组成成分
本产品由动脉管路（包括保护盖、患者接头、管路夹、PVC管、泵管、肝素管、6%内圆锥接头、采样接头、传感器保护器、T接头、透析接头和泵管固定器）、静脉管路（包括保护盖、患者接头、管路夹、PVC管、6%内圆锥接头、采样接头、传感器保护器、T接头、透析接头、气泡捕获器和收集液袋）、滤过液管路（包括保护盖、患者接头、管路夹、PVC管、泵管、6%内圆锥接头、采样接头、传感器保护器、T接头和泵管固定器），置换液管路（包括保护盖、患者接头、管路夹、PVC管、泵管、泵管固定器、Y接头、加热囊和置换液接头）和附件（穿刺器和冲洗接头）组成，产品由环氧乙烷灭菌，一次性使用。
适用范围/预期用途
本产品与机器连接，适用于急性肾衰竭，具体用于静脉-静脉血液滤过、血液透析和血液透析滤过治疗，一次性使用。该产品于体重在10公斤以下的儿童。
一、工作原理（Working Principle）
中文
婴幼儿体外循环建立
经双腔中心静脉导管引出血液，由低流量蠕动泵驱动，以 **＜100mL/min血流量流经AV Paed 小面积滤器 **，通过 ** 对流（CVVH）、弥散（CVVHD）、单纯超滤（SCUF）** 清除水分、代谢废物与炎性介质，净化后血液回输体内。
儿童专用低容量回路
一体化微型管路 + 微型静脉壶 / 滤过器，预充容量＜50mL，大幅减少血液稀释，适配婴幼儿低血容量生理特点。
密闭式安全防护
静脉侧集成微栓过滤器、空气监测室、单向阀、疏水排气膜，全程无菌无空气暴露，防血栓、气栓、漏血与污染。
抗凝与监测
内置肝素 / 枸橼酸抗凝管路与微型压力监测端口（动脉压 / 静脉压 / TMP），适配儿童低流量、高精度监测需求。
English
Pediatric Extracorporeal Circulation
Blood is drawn via a double-lumen central venous catheter, driven by a low-flow peristaltic pump at ＜100mL/min through the small-surface-area AV Paed filter. Fluid, waste, and inflammatory mediators are removed via convection (CVVH), diffusion (CVVHD), or ultrafiltration (SCUF); purified blood is returned.
Low-Volume Pediatric Circuit
Integrated micro-tubing + mini venous chamber/filter with priming volume ＜50mL minimizes hemodilution, matching infants’ low blood volume.
Closed Safety System
Venous side integrates microemboli filter, air detector chamber, check valve, hydrophobic membrane; fully sealed, sterile, air-free to prevent clots, air embolism, leaks, and contamination.
Precision Anticoagulation & Monitoring
Built-in heparin/citrate line and micro pressure ports (ART/VEN/TMP) for low-flow, high-accuracy pediatric monitoring.
二、核心功能（Core Functions）
表格
中文功能 English Function
儿童 CRRT 多模式：支持 CVVH、CVVHD、SCUF，适配新生儿 / 婴幼儿急性肾损伤 Pediatric CRRT Modes: CVVH, CVVHD, SCUF for neonatal/infant AKI
超低预充：总预充＜50mL，减少婴幼儿血液稀释与容量负荷 Ultra-Low Prime: ＜50mL total; minimizes hemodilution & volume overload
安全过滤：微型血栓过滤器 + 空气监测 + 防反流阀，儿童专属安全强化 Safety Filtration: Micro clot filter + air detection + anti-reflux valve; pediatric safety enhancement
抗凝：肝素 / 枸橼酸双抗凝管路，适配儿童低剂量输注 Precision Anticoagulation: Dual heparin/citrate lines for low-dose pediatric delivery
低阻力流畅：微型光滑管路，低血流阻力，保护婴幼儿血细胞 Low Resistance: Smooth micro-tubing; low flow resistance, protects blood cells
全程密闭无菌：无针鲁尔锁 + 密封接头，防感染、防进气、防漏血 Full Closed Sterility: Needle-free Luer locks + sealed connectors; infection/air/leak protection
主机完美适配：与 multiFiltrate、AV Paed 滤器 1:1 匹配，自动识别 System Compatibility: 1:1 match with multiFiltrate & AV Paed; auto-recognized
三、产品特点（Product Features）
中文
新生儿 / 婴幼儿专属设计（核心）
体重＜10kg专用，预充容量≤45mL（含滤器），全球儿童 CRRT 最低预充之一。
微型化全组件：细口径管路、微型静脉壶、微型滤过器、小体积血袋 / 废液袋。
高生物相容性儿童材质
医用TOTM-PVC（无 DEHP）、PU，无乳胶、无热原，低血小板吸附、低炎症反应。
环氧乙烷灭菌，无菌、无毒、一次性使用，避免交叉感染。
临床安全优化
三重防气栓：疏水排气膜 + 空气监测室 + 气泡探测器，100% 气栓拦截。
微栓过滤：≤20µm 高精度过滤器，防血栓栓塞。
防漏防脱：儿童专用鲁尔锁 + 防脱卡扣 + 管路夹，防意外脱落。
压力保护：动脉 / 静脉 / TMP 三重监测，超压自动停泵。
高效便捷临床操作
一体化预装：即拆即用，减少组装步骤、降低污染风险。
颜色编码管路：动脉红 / 静脉蓝 / 废液黄 / 置换绿，快速识别。
自动预冲：适配 multiFiltrate 一键自动预冲，排空气。
合规与认证
注册证：国械注进 20223100192
认证：CE、ISO 13485、FDA、MDR
类别：Ⅲ 类医疗器械，最高安全等级
English
Neonatal/Infant Exclusive Design (Core)
For ＜10kg; priming ≤45mL (w/filter)—one of the lowest for pediatric CRRT globally.
Full micro-components: thin-bore tubing, mini venous chamber, micro-filter, small-volume bags.
Pediatric Biocompatible Materials
TOTM-PVC (DEHP-free), PU; latex-free, non-pyrogenic; low platelet adhesion, minimal inflammation.
EO-sterilized, sterile, non-toxic, single-use to prevent cross-infection.
Max Clinical Safety Optimization
Triple air embolism protection: hydrophobic membrane + air chamber + detector; 100% air block.
Microemboli filtration: ≤20µm high-precision filter; clot embolism protection.
Leak/dislodgement prevention: pediatric Luer locks + clips + clamps.
Pressure protection: ART/VEN/TMP monitoring; auto-stop on overpressure.
Efficient Clinical Workflow
Integrated pre-assembled: ready to use; reduces steps & contamination.
Color-coded lines: ART (red)/VEN (blue)/effluent (yellow)/replacement (green).
Auto-priming: one-touch with multiFiltrate; complete air removal.
Regulatory Compliance
Reg. No.: 国械注进 20223100192
Certifications: CE, ISO 13485, FDA, MDR
Class: Class III medical device, highest safety level
四、技术参数（Technical Specifications）
| 参数（中） | Parameter (En) | 规格 ||---|---|| 型号 | Model | multiFiltrate Paed CRRT/SCUF Set || 适用人群 | Target Population | 新生儿 / 婴幼儿，体重＜10kg || 配套主机 | Compatible Device | multiFiltrate 急性透析机 || 配套滤器 | Compatible Filter | Ultraflux AV Paed（膜面积 0.05m²） || 结构组成 | Components | 动脉 / 静脉管路、微型静脉壶、微栓过滤器、抗凝管路、压力端口、废液 / 置换管路、鲁尔锁、管路夹 || 总预充容量 | Total Priming Volume | ≤45mL（含 AV Paed 滤器） || 血流量范围 | Blood Flow Range | 10–100mL/min（儿童模式） || 滤过 / 透析液 | Effluent/Dialysate | 10–500mL/h（SCUF/CRRT 模式） || 压力监测 | Pressure Monitoring | 动脉压（ART）、静脉压（VEN）、跨膜压（TMP） || 过滤精度 | Filtration Rating | ≤20µm（微栓拦截） || 材质 | Material | TOTM-PVC（无 DEHP）、PU；无乳胶、无热原 || 灭菌方式 | Sterilization | 环氧乙烷（EO）灭菌 || 使用方式 | Usage | 一次性使用，无菌包装 || 注册证号 | Registration No. | 国械注进 20223100192 || 生产厂家 | Manufacturer | Fresenius Medical Care AG & Co. KGaA（德国） || 有效期 | Shelf Life | 2 年（灭菌有效期） |
五、使用方法（Usage Instructions）
中文
1. 治疗前准备
核对型号、有效期、包装完好、无菌，检查管路无扭曲、破损、漏液。
准备multiFiltrate 主机、AV Paed 滤器、500mL 生理盐水、肝素 / 枸橼酸抗凝剂、4.5–6.5F 双腔中心静脉导管。
开机自检，按颜色编码安装管路与滤器，确认连接正确、无夹闭。
2. 密闭式自动预冲
启动儿童模式自动预冲（流量 10–20mL/min），生理盐水→动脉→滤器→静脉，排尽空气。
连接抗凝剂，低剂量预冲抗凝管路（遵医嘱）。
预冲完成，系统自检通过，准备患儿穿刺。
3. 患儿血管通路与连接
无菌操作颈内 / 股静脉穿刺（4.5–6.5F 双腔导管），固定牢固。
连接 ** 动脉（红）/ 静脉（蓝）** 管路至导管，确认无漏血、无气泡。
启动低流量（10–20mL/min），观察循环稳定、压力正常。
4. CRRT/SCUF 治疗启动
选择儿童模式（CVVH/CVVHD/SCUF），设置参数：
血流量：10–80mL/min（＜10kg 患儿）
超滤率：10–100mL/h（SCUF）/ 50–300mL/h（CRRT）
抗凝：肝素 5–10U/kg/h 或 枸橼酸 1–2mmol/kg/h（监测 Ca²⁺）
启动治疗，每 15 分钟监测压力、流量、温度、血气、电解质。
5. 治疗中监护
固定管路，防扭结、受压、脱落；患儿翻身 / 移动时专人保护。
监测生命体征、尿量、凝血、ACT/APTT、血钙，防出血 / 凝血 / 低钙。
报警处理：高压→查管路 / 滤器；气泡→停泵排气；漏血→更换管路。
6. 治疗结束与回血
结束前降低流量至 10mL/min，启动密闭式回血。
生理盐水缓慢回输，排尽管路血液，避免空气进入。
无菌分离导管，压迫止血 10–15 分钟，观察患儿稳定。
管路一次性废弃，按感染性医疗废物处理。
English
1. Pre-Treatment Preparation
Verify model, expiry, package integrity, sterility; inspect tubing for kinks/damage.
Prepare multiFiltrate, AV Paed filter, 500mL saline, heparin/citrate, 4.5–6.5F double-lumen CVC.
Power on self-test; install set/filter per color codes; confirm correct connections.
2. Closed Auto-Priming
Start pediatric auto-prime (10–20mL/min); saline → ART → filter → VEN; fully purge air.
Connect anticoagulant; prime line at low dose (per order).
Prime complete; system pass; ready for patient puncture.
3. Vascular Access & Connection
Aseptically insert 4.5–6.5F double-lumen CVC (IJ/femoral); secure firmly.
Connect ART (red)/VEN (blue) lines to CVC; confirm no leaks/air.
Start low flow (10–20mL/min); confirm stable circulation/pressures.
4. Therapy Initiation
Select pediatric mode (CVVH/CVVHD/SCUF); set parameters:
Blood flow: 10–80mL/min (＜10kg)
Ultrafiltration: 10–100mL/h (SCUF) / 50–300mL/h (CRRT)
Anticoagulation: Heparin 5–10U/kg/h or Citrate 1–2mmol/kg/h (monitor Ca²⁺)
Start therapy; monitor q15min pressures, flow, temp, blood gas, electrolytes.
5. Intra-Treatment Monitoring
Secure lines; prevent kinking/pressure/dislodgement; protect during repositioning.
Monitor vitals, urine output, coagulation, ACT/APTT, Ca²⁺; prevent bleeding/clotting/hypocalcemia.
Alarm response: High pressure → check lines/filter; Air → stop & purge; Leak → replace set.
6. Termination & Blood Return
Reduce flow to 10mL/min; start closed blood return.
Slow saline infusion to return all blood; avoid air entry.
Aseptically disconnect CVC; pressure 10–15min; monitor stability.
Dispose set as infectious waste.
六、适应症（Indications）
中文
体重＜10kg 新生儿 / 婴幼儿，与 multiFiltrate 配套用于：
急性肾损伤（AKI）：伴容量过载、少尿 / 无尿、电解质 / 酸碱紊乱、脓毒症、多器官衰竭
缓慢连续性超滤（SCUF）：严重水肿、心力衰竭、肺水肿、腹水、液体超负荷
CRRT 治疗：CVVH（对流清除中大分子）、CVVHD（弥散清除小分子）、CVVHDF（联合清除）
其他：新生儿溶血、高胆红素血症、药物 / 毒物中毒、先天性代谢病（高氨血症）
English
For neonates/infants ＜10kg with multiFiltrate:
Acute Kidney Injury (AKI): fluid overload, oliguria/anuria, electrolyte/acid-base imbalance, sepsis, MOF
Slow Continuous Ultrafiltration (SCUF): severe edema, heart failure, pulmonary edema, ascites, fluid overload
CRRT: CVVH (convection), CVVHD (diffusion), CVVHDF (combined clearance)
Others: neonatal hemolysis, hyperbilirubinemia, drug/toxin intoxication, inborn errors (hyperammonemia)
七、禁忌症（Contraindications）
中文
绝对禁忌
对TOTM-PVC、PU、肝素、枸橼酸严重过敏者
无法建立有效血管通路（严重血管畸形、闭塞）
严重凝血障碍、DIC、活动性大出血且无法抗凝
严重休克、低血压（SBP＜50mmHg）、血流动力学极不稳定
颅内出血、脑疝、严重缺氧（CRRT 禁忌）
家属 / 法定代理人明确拒绝体外循环治疗
相对禁忌（慎用）
体重＜2kg极低出生体重儿（需专业评估）
严重肝功能衰竭（枸橼酸代谢障碍，慎用枸橼酸抗凝）
严重贫血（Hb＜80g/L）、血小板＜50×10⁹/L
胎龄＜32 周早产儿（凝血功能未成熟）
English
Absolute Contraindications
Severe allergy to TOTM-PVC, PU, heparin, citrate
Inadequate vascular access (severe vascular malｆormation/occlusion)
Severe coagulopathy, DIC, active bleeding with uncontrollable hemorrhage
Severe shock, hypotension (SBP＜50mmHg), hemodynamic instability
Intracranial hemorrhage, herniation, severe hypoxia
Patient/legal guardian refusal of extracorporeal therapy
Relative Contraindications (Caution)
＜2kg extremely low birth weight (specialist evaluation)
Severe liver failure (citrate ｍmbedbolism impairment)
Severe anemia (Hb＜80g/L), platelets ＜50×10⁹/L
＜32 weeks preterm (immature coagulation)
八、注意事项（Precautions）
中文
专业资质：新生儿 / 儿童 ICU 持证医师 / 护士操作，严格无菌 SOP
术前核查：过期 / 破损 / 污染 / 漏气严禁使用；管路扭曲打折禁止上机
耗材匹配：仅与 multiFiltrate+AV Paed 配套，禁止混用其他品牌 / 型号
容量安全：预充≤45mL，严防血液稀释；回血充分，防低血容量
抗凝：儿童低剂量个体化，监测 ACT/APTT/ 血钙，防出血 / 凝血 / 低钙
气栓防控：预冲排气；全程空气监测；防管路脱落致气栓
压力监测：动脉 / 静脉 / TMP实时监测，超压立即停泵处理
患儿保护：约束固定、保暖、镇静，防躁动拔管；专人全程监护
时限管理：一次性使用，开封 4 小时未用废弃；连续治疗≤72 小时（遵医嘱）
并发症处理
低钙血症（枸橼酸）：补钙（10% 葡萄糖酸钙 1–2mL/kg）
出血 / 凝血：调整抗凝；必要时输血 / 更换管路
感染：无菌操作；管路污染立即更换
管路脱落：紧急夹闭；止血；重新穿刺
English
Qualified Use: Only certified pediatric/neonatal ICU staff; strict aseptic SOP
Pre-Check: Expired/damaged/contaminated/leaking → DO NOT use; kinked tubing → discard
Compatibility: Only for multiFiltrate+AV Paed; no cross-brand use
Volume Safety: Prime ≤45mL; avoid hemodilution; full reinfusion to prevent hypovolemia
Precision Anticoagulation: Low-dose pediatric titration; monitor ACT/APTT/Ca²⁺; prevent bleeding/clotting/hypocalcemia
Air Embolism Prevention: Thorough priming; continuous air detection; secure lines
Pressure Monitoring: Real-time ART/VEN/TMP; immediate stop on overpressure
Patient Protection: Restrain, warm, sedate; prevent dislodgement; 1:1 monitoring
Time Management: Single-use only; discard if unused 4hrs after opening; therapy ≤72hrs
Complication Management
Hypocalcemia (citrate): Calcium gluconate 1–2mL/kg IV
Bleeding/clotting: Adjust anticoagulant; transfusion/set replacement if needed
Infection: Aseptic technique; immediate set replacement if contaminated
Dislodgement: Clamp lines; hemostasis; re-puncture
九、存储条件（Storage Conditions）
中文
温度：15–25℃（室温），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、防电磁干扰
禁止：冷冻、阳光直射、高温、潮湿、放射性、震动、重压
有效期：灭菌后 2 年，包装标识有效期前使用
运输：-10℃～40℃，防剧烈震动、摔落、雨淋
使用前：室温平衡30 分钟，检查无菌包装完好后使用
English
Temperature: 15–25℃ (room temp); avoid <5℃ or >40℃
Humidity: 30–70%RH, non-condensing
Environment: Dry, ventilated, dark, dust/corrosion/EMI-proof
Prohibited: Freezing, sun, heat, moisture, radiation, shock, heavy pressure
Shelf Life: 2 years (sterilized); use before labeled expiry
Shipping: -10℃～40℃; protect from shock, drop, rain
Pre-Use: Equilibrate 30 mins at room temp; confirm sterile package intact
十、说明书核心信息（Manual Key Inｆormation）
中文
产品标识：名称连续性血液净化管路、型号multiFiltrate Paed CRRT/SCUF Set、注册证国械注进 20223100192、批号、有效期、厂家Fresenius Medical Care
组成：一次性无菌儿童管路、微型静脉壶、微栓过滤器、抗凝 / 压力 / 废液 / 置换管路、鲁尔锁、管路夹
适用范围：与multiFiltrate+AV Paed配套，体重＜10kg 新生儿 / 婴幼儿急性肾损伤 CRRT/SCUF 治疗
操作核心：超低预充、儿童模式、自动预冲、密闭循环、抗凝、全程安全监测
安全警告
一次性使用，严禁重复灭菌 / 使用
仅儿童 ICU 专业人员操作，非无菌使用致感染责任自负
过敏 / 凝血 / 气栓 / 低钙风险，严密监测
体重＜10kg专用，禁止用于＞10kg 儿童
维护保养：无维护，一次性使用后废弃
废弃处理：按医疗感染性废物处置，遵守当地法规
责任声明：未按说明书操作致不良事件，使用者承担全部责任
English
Labeling: Continuous Blood Purification Tubing, Model multiFiltrate Paed CRRT/SCUF Set, Reg No. 国械注进 20223100192, Lot, Expiry, Fresenius Medical Care
Components: Sterile single-use pediatric tubing, mini venous chamber, microemboli filter, anticoag/pressure/effluent/replacement lines, Luer locks, clamps
Intended Use: With multiFiltrate+AV Paed for neonates/infants ＜10kg with AKI (CRRT/SCUF)
Critical Steps: Ultra-low prime, pediatric mode, auto-prime, closed circuit, precision anticoagulation, full safety monitoring
Warnings
Single-use only; DO NOT re-sterilize/reuse
For pediatric ICU professionals only; user liable for infection from non-sterile use
Allergy/clot/air/hypocalcemia risks; close monitoring required
For ＜10kg only; do not use on ＞10kg patients
Maintenance: No maintenance; dispose after single use
Disposal: Dispose as infectious medical waste per local regulations
Liability: User fully liable for adverse events from 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.
热门标签：厂家费森尤斯连续性血液净化管路multiFiltrate,Paed,CRRT/SCUF,Set,费森尤斯连续性血液净化管路,费森尤斯血液净化管路
