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厂家费森尤斯连续性血液净化管路multiFiltratePRO Ci-Ca HD
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厂家费森尤斯连续性血液净化管路multiFiltratePRO Ci-Ca HD
桂经理19117326863微xin同号
管理类别
第三类
型号规格
multiFiltratePRO Ci-Ca HD, multiFiltratePRO Ci-Ca HDF, multiFiltratePRO HDF, Adapter Hansen male/Luer-lock male
结构及组成/主要组成成分
multiFiltratePRO HDF 包括动/静脉管路系统、滤过液管路系统、透析液管路系统、置换液管路系统；multiFiltratePRO Ci-Ca HD 包括动/静脉管路系统、滤过液管路系统、透析液管路系统、枸橼酸及钙剂管路系统；multiFiltratePRO Ci-Ca HDF 包括动/静脉管路系统、滤过液管路系统、透析液管路系统、置换液管路系统、枸橼酸及钙剂管路系统。Adapter Hansen male/Luer-lock male 包括盖帽、PVC管路，接头。一次性使用，经环氧乙烷灭菌。
适用范围/预期用途
本产品适用于连续性血液净化治疗。multiFiltratePRO HDF 型号可用于CVVH，CVVHD和CVVHDF三种治疗模式，multiFiltratePRO Ci-Ca HD 型号可用于CVVHD模式，multiFiltratePRO Ci-Ca HDF 型号可用于CVVHDF治疗模式。
一、工作原理（Working Principle）
中文
体外循环通路：作为血液与置换液、透析液的封闭式输送通道，通过动脉端（红色）引出血液，经滤器 / 透析器净化后，由静脉端（蓝色）回输体内。
弥散清除为主（CVVHD）：依托半透膜两侧 溶质浓度梯度，通过弥散作用高效清除小分子毒素（尿素、肌酐、钾离子）；同时通过跨膜压实现 超滤脱水，清除体内多余水分。
Ci-Ca 枸橼酸抗凝集成：管路专属设计 枸橼酸（Citrate）与钙剂（Calcium）输注端口 / 管路，配合设备专用泵，实现 体外循环局部抗凝。枸橼酸在管路中络合钙离子抑制凝血，回输前由钙剂泵补充钙离子，既防管路凝血，又避免全身出血风险。
全闭环液体管理：集成透析液（绿色）、废液（黄色）、置换液管路，配合设备自动平衡控制，实现治疗中液体出入量调控。
English
Extracorporeal Circulation Pathway: Serves as a closed conduit for blood, replacement fluid, and dialysate. Blood is drawn via the arterial line (red), purified through the dialyzer, and returned via the venous line (blue).
Diffusion-based Clearance (CVVHD): Removes small molecular toxins (urea, creatinine, K⁺) primarily via diffusion driven by concentration gradients across the semipermeable membrane. Ultrafiltration via transmembrane pressure removes excess fluid.
Integrated Ci-Ca Regional Anticoagulation: Features dedicated citrate and calcium infusion lines/ports for the device’s specialized pumps. Citrate chelates calcium in the circuit to prevent clotting; calcium is infused pre-return to reverse anticoagulation, avoiding systemic bleeding risk.
Closed-loop Fluid Management: Integrates dialysate (green), effluent (yellow), and replacement lines, enabling precise automatic fluid balance control.
二、核心功能（Core Functions）
表格
中文功能 English Function
CVVHD 治疗通路：连续性静脉 - 静脉血液透析专用血液 / 液体回路 CVVHD Circuit: Dedicated blood/fluid pathway for continuous veno-venous hemodialysis
Ci-Ca 抗凝集成：枸橼酸 / 钙剂专属输注管路，支持局部枸橼酸抗凝 Ci-Ca Anticoagulation: Integrated citrate/calcium lines for regional citrate anticoagulation
多流体输送：透析液供给、废液排出、置换液 / 补液输注 Multi-fluid Delivery: Dialysate supply, effluent drainage, replacement/infusion fluid delivery
压力监测：动脉压、静脉压、滤器前压监测端口 Pressure Monitoring: Ports for arterial, venous, and pre-filter pressure sensing
安全防护：空气捕获 Chamber、微栓滤器、防反流设计 Safety Features: Air trap chamber, microemboli filter, anti-reflux design
治疗数据联动：与 multiFiltratePRO 设备通信，同步流速、容量、报警 Data Sync: Communicates with multiFiltratePRO for flow, volume, and alarm synchronization
无菌样本采集：内置采样口，治疗中无菌采血 Sterile Sampling: Integrated ports for sterile blood sampling during treatment
三、产品特点（Product Features）
中文
Ci-Ca 专用设计：HD 模式专属，管路布局匹配枸橼酸 / 钙泵，抗凝、稳定，降低凝血与出血风险。
一次性无菌：环氧乙烷（EO）灭菌、无热原、单人单次使用，杜绝交叉感染。
低预充容量：体外循环血量低（≤150ml），减少对患者血流动力学影响。
长时治疗：支持 长达 72 小时 连续 CRRT 治疗，结构稳定、抗凝可靠。
生物相容性：血液接触材料为 医用级 PVC/PC，低血小板黏附、低补体激活。
安全集成：一体化空气捕获器、微栓滤器、防气泡、防反流，多重安全保障。
操作高效：色标编码管路（红 / 蓝 / 绿 / 黄）、卡扣式连接，安装快速、防误接。
ICU 适配：兼容危重患者，配合设备温控、自动平衡，提升治疗安全性。
English
Ci-Ca Specific Design: Optimized for HD mode; layout matches citrate/calcium pumps for precise, stable anticoagulation, reducing clotting/bleeding risk.
Single-use Sterile: Ethylene Oxide (EO) sterilized, pyrogen-free, single-patient use to eliminate cross-infection.
Low Priming Volume: Extracorporeal volume ≤150ml, minimizing hemodynamic impact.
Long-duration Therapy: Supports up to 72 hours of continuous CRRT with stable structure and reliable anticoagulation.
Biocompatible: Blood-contacting materials (medical-grade PVC/PC) offer low platelet adhesion and complement activation.
Integrated Safety: All-in-one air trap, microemboli filter, air and anti-reflux protection.
User-friendly: Color-coded lines (red/blue/green/yellow), snap-fit connections for fast, error-proof setup.
ICU-optimized: Safe for critically ill patients; compatible with device heating and auto-balance.
四、技术参数（Technical Specifications）
表格
中文参数 英文参数
产品型号 Product Model
multiFiltratePRO Ci-Ca HD multiFiltratePRO Ci-Ca HD (SecuCas Ci-Ca HD)
配套主机 Compatible Device
multiFiltratePRO 连续性血液净化设备 multiFiltratePRO Continuous Blood Purification System
治疗模式 Therapy Mode
连续性静脉 - 静脉血液透析（CVVHD）+ Ci-Ca 抗凝 Continuous Veno-Venous Hemodialysis (CVVHD) + Ci-Ca Anticoagulation
结构组成 Components
动脉管路（红）、静脉管路（蓝）、透析液管路（绿）、废液管路（黄）、枸橼酸 / 钙输注管路、空气捕获 Chamber、微栓滤器、采样口、压力监测口、无菌接头 Arterial line (red), Venous line (blue), Dialysate line (green), Effluent line (yellow), Citrate/Calcium lines, Air trap, Microemboli filter, Sampling ports, Pressure ports, Sterile connectors
血液接触材料 Blood-contacting Materials
医用软 PVC、聚碳酸酯（PC）、聚丙烯（PP） Medical-grade soft PVC, Polycarbonate (PC), Polypropylene (PP)
预充容量 Priming Volume
≤ 150 mL ≤ 150 mL
灭菌方式 Sterilization
环氧乙烷（EO）灭菌 Ethylene Oxide (EO) Sterilized
使用时限 Maximum Use Time
连续使用 ≤ 72 小时 Up to 72 hours continuous use
产品认证 Certifications
CE 认证、中国 NMPA 注册（国械注进） CE Certified, NMPA Registered
保质期 Shelf Life
灭菌后 24 个月 24 months from sterilization
五、使用方法（Usage Instructions）
中文
术前检查
确认包装完好、灭菌有效期、型号（Ci-Ca HD），无破损、潮湿、污染。
核对患者信息、医嘱、CVVHD 治疗方案、Ci-Ca 抗凝参数。
管路安装
严格无菌操作，打开包装，按设备指引与色标连接至 multiFiltratePRO。
连接枸橼酸、钙剂、透析液、废液袋，确认管路通畅、无扭曲、无气泡。
预充排气
启动设备预充程序，用生理盐水 / 置换液充满管路，排尽空气。
检查压力监测、报警功能、液体平衡系统正常。
患者连接
建立中心静脉通路，动脉端（红）接引血，静脉端（蓝）接回输。
启动低流速，确认回路无渗漏、无凝血、患者无不适。
治疗运行
设定参数：血流量、透析液流量、超滤量、枸橼酸 / 钙流速。
实时监测：压力、温度、血气、电解质（离子钙）、凝血状态。
处理报警：压力异常、空气、低钙 / 高钙、液体失衡等。
治疗结束
减速停机，夹闭管路，安全断开患者端。
生理盐水回血，拔管 / 封管，按压止血。
管路按医疗废物销毁，记录治疗数据。
English
Pre-treatment Inspection
Verify package integrity, expiry, model (Ci-Ca HD); no damage, moisture, or contamination.
Confirm patient ID, orders, CVVHD plan, and Ci-Ca parameters.
Set Installation
Aseptic technique; open package; connect to multiFiltratePRO per color codes.
Attach citrate, calcium, dialysate, effluent bags; ensure patency, no kinks, no air.
Priming & De-airing
Run auto-prime with saline/replacement fluid to fill circuit and purge air.
Confirm pressure monitoring, alarms, and fluid balance function normally.
Patient Connection
Establish central venous access; connect arterial (red) to draw, venous (blue) to return.
Start low flow; check for leaks, clotting, patient tolerance.
Treatment Operation
Set parameters: blood flow, dialysate flow, ultrafiltration, citrate/calcium rates.
Monitor: pressures, temperature, blood gas, electrolytes (iCa), clotting status.
Troubleshoot alarms: pressure, air, hypocalcemia/hypercalcemia, fluid imbalance.
Termination
Reduce flow, stop, clamp lines, disconnect safely.
Saline flush back; remove catheter, apply pressure.
Discard set as medical waste; document treatment data.
六、适应症（Indications）
中文
急性肾损伤（AKI）：需 连续性肾脏替代治疗（CRRT）、伴高出血风险或肝素禁忌者。
严重电解质 / 酸碱紊乱：高钾血症、代谢性酸中毒、高钠血症等紧急纠正。
容量超负荷：急性心衰、肺水肿、严重水肿，需缓慢持续脱水。
重症感染 / 脓毒症：合并 AKI，需清除炎症因子、维持内环境稳定。
药物 / 毒物中毒：小分子毒素或药物过量，需持续清除。
适用人群：需 CVVHD + 枸橼酸抗凝 的危重患者（≥40kg）。
English
Acute Kidney Injury (AKI): Requiring CRRT with high bleeding risk or heparin contraindication.
Severe Electrolyte/Acid-Base Disorders: Emergency correction of hyperkalemia, ｍmbedbolic acidosis, hypernatremia.
Volume Overload: Acute heart failure, pulmonary edema, severe edema requiring slow, continuous fluid removal.
Severe Sepsis: With AKI, needing inflammatory mediator clearance and homeostasis.
Drug/Toxic Poisoning: Small-molecule toxins or overdose requiring continuous removal.
Population: Critically ill patients (≥40kg) needing CVVHD with citrate anticoagulation.
七、禁忌症（Contraindications）
中文
绝对禁忌
对 管路材料（PVC/PC） 或 环氧乙烷残留 严重过敏。
无法建立有效中心静脉通路。
严重 无法纠正的低血压、休克（无法耐受体外循环）。
严重 凝血功能障碍 伴活动性出血（枸橼酸抗凝仍高危）。
相对禁忌
严重 肝功能衰竭（枸橼酸代谢障碍，易蓄积致低钙 / 酸中毒）。
严重 低钙血症、高乳酸血症。
无法配合治疗、严重精神障碍。
English
Absolute Contraindications
Severe hypersensitivity to tubing materials (PVC/PC) or EO residues.
Inability to establish adequate central venous access.
Severe uncorrectable hypotension/shock (cannot tolerate extracorporeal circuit).
Severe coagulopathy with active bleeding (high risk despite citrate).
Relative Contraindications
Severe liver failure (impaired citrate ｍmbedbolism → hypocalcemia/acidosis).
Severe hypocalcemia, hyperlactatemia.
Uncooperative or severe psychiatric disorders.
八、注意事项（Precautions）
中文
一次性使用：严禁 重复、清洗、灭菌、共用，包装破损 / 过期禁用。
无菌操作：全程 ICU 无菌标准，防导管相关血流感染。
抗凝监测：Ci-Ca 治疗需 每 4–6 小时监测离子钙，调整钙泵流速。
防空气栓塞：预充、管路无气泡；空气报警立即停机排查。
压力监控：动脉 / 静脉 / 滤器压异常，立即检查管路、滤器、血管通路。
液体平衡：严格核对袋量、浓度，防超滤过多致低血压或容量不足。
并发症警惕：低钙（麻木、抽搐）、高钙（嗜睡、心律失常）、凝血、出血、感染。
特殊人群：儿童、老年、肝衰患者 减量、慢流速、强化监测。
废物处理：使用后按 感染性医疗废物 规范处置。
English
Single-use Only: Do not reuse, clean, resterilize, or share. Discard if damaged/expired.
Aseptic Technique: Full ICU sterile protocol to prevent CRBSI.
Anticoagulation Monitoring: Check ionized calcium q4–6h during Ci-Ca; adjust calcium pump.
Air Embolism Prevention: Complete priming; no air bubbles. Stop immediately for air alarm.
Pressure Surveillance: Investigate line, filter, or access issues for abnormal pressures.
Fluid Balance: Verify bag volumes/concentrations; avoid excessive ultrafiltration (hypotension/hypovolemia).
Complication Watch: Hypocalcemia (paresthesia, tetany), hypercalcemia (lethargy, arrhythmia), clotting, bleeding, infection.
Special Populations: Reduce flow, extend time, intensify monitoring in pediatric, elderly, or liver failure patients.
Waste Disposal: Dispose as infectious medical waste.
九、存储条件（Storage Conditions）
中文
温度：5–30℃，避免冷冻、高温（＞40℃）、阳光直射。
湿度：相对湿度＜80%，干燥、通风、无腐蚀性气体。
环境：无尘、无菌、无虫害，平放，防挤压、穿刺、重压。
保存：灭菌包装 密封避光，有效期内使用；禁用已破损或污染包装。
English
Temperature: 5–30°C; avoid freezing, heat (>40°C), direct sunlight.
Humidity: RH < 80%; dry, ventilated area; no corrosive gases.
Environment: Dust-free, sterile, pest-free; store flat; protect from crushing, puncture, heavy pressure.
Storage: Keep sterile package sealed and light-protected; use before expiry. Discard damaged/contaminated packages.
十、说明书核心信息（Manual Key Inｆormation）
中文
产品标识：名称、型号、UDI、注册证、生产批号、灭菌 / 有效期。
结构原理：组件图、Ci-Ca HD 工作原理、适配设备、治疗模式。
适应症 / 禁忌症：临床适用范围、绝对 / 相对禁忌、风险提示。
操作流程：安装、预充、连接、运行、监测、停机、废物处理全步骤。
技术参数：材料、规格、预充量、使用时限、兼容性。
安全警示：一次性使用、无菌要求、抗凝监测、报警处理、并发症防控。
维护保养：无维护（一次性），仅存储、检查、失效处置。
责任声明： 持证医护、合规医疗机构 使用，违规责任自负。
English
Product Identification: Name, model, UDI, registration, lot, sterilization/expiry dates.
Structure & Principle: Component diagram, Ci-Ca HD mechanism, compatible devices, therapy modes.
Indications/Contraindications: Clinical use, absolute/relative contraindications, risk warnings.
Procedure: Step-by-step installation, priming, connection, operation, monitoring, termination, disposal.
Specifications: Materials, dimensions, priming volume, use time, compatibility.
Safety Warnings: Single-use, sterility, anticoagulation monitoring, alarm management, complication prevention.
Maintenance: No maintenance (single-use); storage, inspection, disposal of expired sets.
Liability: For use only by trained staff in licensed facilities; misuse at user’s risk.
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multiFiltratePRO,Ci-Ca,HD,费森尤斯连续性血液净化管路,费森尤斯血液净化管路
