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厂家直供费森尤斯一次性血液成分分离管路C6R8880,C6R8882
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厂家直供费森尤斯一次性血液成分分离管路C6R8880,C6R8882
桂经理19117326863微xin同号
管理类别
第三类
型号规格
C6R8880、C6R8882、C7R8880、C7R8882
结构及组成/主要组成成分
本产品由0.2µm药液过滤器（盐水管路、抗凝剂管路）、穿刺器滴斗组件（盐水管路、抗凝剂管路）、夹具、滚动夹、Y-型接头、血小板容量标签、塑料滑动夹-封闭式、机用采血器、软管、红细胞袋600mL、血浆袋1000 mL（C6R8880, C6R8882）或血浆袋800mL（C7R8880, C7R8882）、血小板袋1000mL、血液采样袋50mL、控制盒、多腔管、保护套、血小板采样袋5mL、分离袋140mL和收集袋150mL组成
适用范围/预期用途
C6R8880，C6R8882与AmiCORE血液成分分离机配套使用，用于血小板的采集及存储，血小板最多可保存5天。C7R8880，C7R8882与AmiCORE离心式血液成分分离机配套使用，用于血小板的采集及储存和血浆的采集，血小板最多可保存5天
次性血液成分分离管路 C6R8880、C6R8882（配套 Haemonetics MCS + 等血细胞分离机）为一次性密闭式离心分离管路，C6R8880 用于单份血小板采集，C6R8882 用于双份血小板采集，同时可分离血浆、红细胞，实现成分血单采与治疗性分离。
一、工作原理（Working Principle）
中文
基于密度梯度离心与密闭式体外循环原理：
体外循环：全血经采血针→管路→离心杯，分离后剩余成分回输体内，全程无菌密闭。
离心分层：离心杯 2000–3000rpm 旋转，按密度分层：红细胞（最外层）→白细胞 / 血小板层→血浆（最内层）。
光学识别：设备红外监测界面，定位血小板层（PRP/PC），自动收集至专用袋。
连续循环：多次循环富集，C6R8880 单循环、C6R8882 双循环，提升血小板采集量。
抗凝与回输：肝素 / ACD-A 持续抗凝；分离后红细胞、血浆同步回输，仅保留目标成分。
English
Based on density gradient centrifugation & closed extracorporeal circuit:
Closed Circuit: Whole blood flows from needle → tubing → centrifuge bowl; residual components returned; sterile closed system.
Centrifugal Separation: Bowl spins at 2000–3000rpm; ｌayers by density: RBC (outer) → WBC/platelet → plasma (inner).
Optical Detection: Infrared sensor locates platelet ｌayer (PRP/PC); automated collection.
Cyclic Processing: C6R8880 (single-cycle) / C6R8882 (dual-cycle) for higher yield.
Anticoagulation & Return: ACD-A/heparin anticoagulation; RBC/plasma continuously returned.
二、核心功能（Core Functions）
表格
中文功能 English Function
单采血小板：C6R8880 单份（≥2.5×10¹¹）、C6R8882 双份（≥5.0×10¹¹） Platelet Apheresis: Single (C6R8880) / Double (C6R8882) dose (≥2.5/5.0×10¹¹)
血浆分离：采集新鲜冰冻血浆（FFP），去除致病因子 Plasma Collection: Fresh frozen plasma (FFP) & therapeutic plasma exchange
红细胞采集 / 回输：自体血储备、贫血治疗、红细胞单采 RBC Collection/Return: Autologous storage, anemia, erythrocytapheresis
白细胞去除：采集 / 去除白细胞，降低输血反应 Leukoreduction: Minimize WBC contamination, reduce transfusion reactions
治疗性分离：血小板增多、红细胞增多、血浆置换（TPE） Therapeutic Separation: Thrombocytosis, polycythemia, TPE
密闭无菌：无空气暴露、防交叉感染、无微粒污染 Closed Sterile System: Airtight, no cross-contamination
容量平衡：全程等容，血流动力学稳定、低容量波动 Volume Balance: Isovolemic, stable hemodynamics
一次性使用：EO 灭菌、无热原、单人单次、防复用 Single-Use Sterile: EO sterilized, pyrogen-free
三、产品特点（Product Features）
中文
双型号匹配
C6R8880：单份血小板，容量 250–300mL，单人份治疗量
C6R8882：双份血小板，容量 500–600mL，双人份治疗量
高效高纯度
血小板回收率 **≥85%、白细胞残留＜1×10⁶/ 单位 **（无过滤）
血浆纯度 **≥95%**、红细胞污染＜0.1%
密闭安全设计
一体化管路 + 离心杯 + 采集袋，无接口泄漏、无空气栓塞
压力 / 气泡 / 漏血监测，异常自动停泵、报警
生物相容
医用 PVC/PU 材质，无致敏、无溶血、无热原
抗凝管路预设计，血流顺畅、低凝血风险
操作便捷
预装一体化、即开即用、自动预冲、快速安装
适配 MCS + 等主流设备，图形化引导、参数自动匹配
合规认证
符合 GB 18469、ISO 13485、CE、NMPA
血小板质量达标：≥2.5×10¹¹/ 单份、≥5.0×10¹¹/ 双份
English
Dual Model Precision
C6R8880: Single-dose platelets (250–300mL)
C6R8882: Double-dose platelets (500–600mL)
High Efficiency & Purity
Platelet recovery ≥85%, WBC <1×10⁶/unit (no filter)
Plasma purity ≥95%, RBC contamination <0.1%
Closed Safety System
All-in-one tubing/bowl/bags; leak-proof, airtight
Pressure/air/leak monitors; auto-stop on fault
Biocompatible
Medical PVC/PU; non-toxic, non-hemolytic, pyrogen-free
Easy Operation
Pre-assembled; ready-to-use, auto-prime
Compatible with MCS+; automated setup
Certified
GB 18469, ISO 13485, CE, NMPA
Platelet yield: ≥2.5/5.0×10¹¹
四、技术参数（Technical Specifications）
表格
参数（中） Parameter (En) C6R8880 C6R8882
型号 Model C6R8880 C6R8882
适用模式 Therapy 单份血小板 双份血小板
血小板产量 Platelet Yield ≥2.5×10¹¹/ 袋 ≥5.0×10¹¹/ 袋
血浆容量 Plasma Volume 250–300mL 500–600mL
离心杯容积 Bowl Volume 125mL 125mL
管路材质 Material 医用 PVC/PU 医用 PVC/PU
抗凝剂 Anticoagulant ACD-A、肝素 ACD-A、肝素
血流速度 Blood Flow 40–100mL/min 40–100mL/min
循环次数 Cycles 单循环 双循环
白细胞残留 WBC Contamination ＜1×10⁶/ 单位 ＜1×10⁶/ 单位
灭菌方式 Sterilization EO 环氧乙烷 EO 环氧乙烷
有效期 Shelf Life 3 年 3 年
包装 Pack 1 套 / 无菌袋 1 套 / 无菌袋
配套设备 Compatible Haemonetics MCS + 等 Haemonetics MCS + 等
五、使用方法（Usage Instructions）
中文
术前准备
核对型号、有效期、包装无破损。
洗手、无菌手套；设备自检、安装管路、离心杯、采集袋。
连接抗凝剂（ACD-A）、生理盐水；自动预冲排气。
患者评估：血常规、血小板、凝血、体重、血管条件。
穿刺与上机
肘部静脉消毒（酒精 + 碘伏），16G 采血针穿刺。
连接动脉管路，启动血泵（40–60mL/min）。
回血确认后，设置：模式（单 / 双份）、血流、抗凝比例、循环次数。
分离采集
自动离心分层、光学识别、血小板 / 血浆收集。
实时监测：血流、压力、气泡、容量、抗凝。
每 15 分钟记录：血压、心率、穿刺口、管路状态。
报警处理：停泵→排查→处理→重启，严禁带故障运行。
结束与回输
采集完成，自动生理盐水回输（200–300mL）。
拔针、压迫10–15 分钟止血。
分离管路、离心杯、采集袋；一次性废弃（感染性废物）。
设备消毒、记录存档。
English
Prep
Verify model, expiry, intact package.
Aseptic technique; install kit, bowl, bags; auto-prime.
Connect ACD-A/saline; patient lab review.
Puncture & Connection
Sterilize antecubital vein; 16G needle.
Connect arterial line; start pump (40–60mL/min).
Set: single/double dose, flow, anticoag ratio.
Separation
Automated centrifugation, optical detection, platelet collection.
Monitor: flow, pressure, air, volume, anticoag.
Record VS q15min; check site/lines.
Alarms: stop→fix→restart; no fault operation.
Termination
Saline return (200–300mL).
Remove needle; pressure 10–15 mins.
Single-use disposal (infectious waste).
Disinfect device; document.
六、适应症（Indications）
中文
血小板采集：肿瘤化疗、造血干细胞移植、手术患者血小板输注
血浆采集：新鲜冰冻血浆（FFP）、凝血因子、免疫球蛋白制备
治疗性单采
血小板增多症（原发性 / 继发性）
红细胞增多症、高黏滞综合征
血栓性血小板减少性紫癜（TTP）、溶血尿毒综合征（HUS）
重症肌无力、格林 - 巴利综合征、自身免疫病（血浆置换）
自体储备：术前血小板 / 血浆自体采集、术中回输
献血者采集：健康献血者成分献血（单 / 双份血小板）
English
Platelet Collection: Chemotherapy, transplant, surgery support
Plasma Collection: FFP, clotting factors, Ig manufacturing
Therapeutic Apheresis
Thrombocytosis, polycythemia, hyperviscosity
TTP, HUS
Myasthenia gravis, GBS, autoimmune diseases (TPE)
Autologous Storage: Pre-op collection & intra-op return
Donation: Healthy donor platelet apheresis
七、禁忌症（Contraindications）
中文
绝对禁忌
血小板＜100×10⁹/L、Hb＜110g/L（献血者）
严重凝血障碍、活动性出血、DIC
穿刺部位感染、静脉炎、血栓
对ACD-A、肝素、PVC严重过敏
休克、心衰、严重心律失常、不稳定心绞痛
精神异常、不配合、未成年人（＜18 岁）
相对禁忌（慎行）
体重＜50kg、血管条件差
妊娠、产后＜6 个月
近期手术（＜4 周）、感染、发热
服用抗血小板 / 抗凝药（阿司匹林、华法林）
高血压（＞180/100mmHg）、低血压（＜90/60mmHg）
English
Absolute
Platelets <100×10⁹/L, Hb <110g/L (donors)
Severe coagulopathy, active bleeding, DIC
Infection, phlebitis, thrombosis at site
Severe allergy to ACD-A, heparin, PVC
Shock, heart failure, unstable angina
Psychosis, uncooperative, <18yo
Relative (Caution)
<50kg, poor veins
Pregnancy, <6mo post-partum
<4wk surgery, infection, fever
Antiplatelet/anticoagulant use
HTN (>180/100), hypotension (<90/60)
八、注意事项（Precautions）
中文
专业操作：持证医师 / 护士，严格无菌、SOP
术前检查：包装破损、过期、污染严禁使用
型号匹配：C6R8880（单份）、C6R8882（双份），不可混用
抗凝规范：ACD-A 比例1:9–1:11，防低钙（口唇麻木），必要时补钙
容量控制：全程等容，防容量过载 / 不足、低血压、晕厥
监测密集：每 15 分钟生命体征、压力、气泡、穿刺口
报警处置：不屏蔽、不停泵强行运行，先处理再继续
一次性使用：严禁复用、再灭菌，按医疗废物处置
不良反应：低钙、头晕、恶心、血肿、感染，立即处理
记录完整：采集量、血小板数、不良反应、操作者、日期
English
Professional Use: Licensed staff, strict asepsis/SOP
Pre-Check: Do not use if damaged/expired
Model Match: C6R8880 (single) / C6R8882 (double); no interchange
Anticoag: ACD-A 1:9–1:11; watch hypocalcemia; supplement calcium
Volume: Isovolemic; avoid overload/hypotension/syncope
Monitoring: VS q15min; pressure/air/site
Alarms: No bypass/forced run; fix first
Single-Use: No reuse/re-sterilize; medical waste
Reactions: Hypocalcemia, dizziness, hematoma; treat promptly
Documentation: Yield, count, events, staff, date
九、存储条件（Storage Conditions）
中文
未开封
温度：15–30℃（常温），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、防锐器 / 挤压
禁止冷冻、阳光直射、高温、潮湿
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
English
Unopened
Temp: 15–30°C; avoid <5°C or >40°C
Humidity: 30–70%RH, non-condensing
Environment: Dry, ventilated, light/dust/corrosion-proof
No freezing, sun, heat, moisture
Shipping
Temp: -10°C～40°C; shock/drop/rain protection
Pre-Use
Equilibrate 30 mins at room temp
十、说明书核心信息（Manual Key Inｆormation）
中文
产品标识：名称、型号（C6R8880/C6R8882）、注册证、批号、灭菌 / 失效日期、厂家
组成：采血针、动脉 / 静脉管路、离心杯、血小板袋、血浆袋、抗凝管路、止液夹、滤器、压力监测管
适用范围：单 / 双份血小板采集、血浆分离、治疗性单采、自体血储备（适配 MCS+）
操作流程：准备→安装→预冲→穿刺→分离→监测→回输→废弃→消毒
安全警告：防过敏、低钙、容量异常、空气栓塞、感染、凝血、管路破裂
规格选择：单份选 C6R8880、双份选 C6R8882；按体重 / 血管 / 血小板量匹配
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；违规致不良事件，使用者担责；非原厂配件致损不保
English
Labeling: Name, model (C6R8880/C6R8882), Reg No., lot, expiry, manufacturer
Components: Needle, lines, bowl, platelet/plasma bags, anticoag tubing, clamps, filters
Intended Use: Single/double platelet apheresis, plasma collection, therapeutic apheresis (MCS+)
Workflow: Prep→Install→Prime→Puncture→Separate→Monitor→Return→Dispose→Disinfect
Warnings: Allergy, hypocalcemia, volume, air embolism, infection, clot, rupture
Selection: C6R8880 (single), C6R8882 (double); match weight/veins/platelets
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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