厂家供应唯美自体血液回收机CSE-E-CM,CSE-EW-CM
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厂家供应唯美自体血液回收机CSE-E-CM,CSE-EW-CM
桂经理19117326863微xin同号
第三类
型号规格
CSE-E-CM、CSE-EW-CM
结构及组成/主要组成成分
该产品由离心机系统、泵、空气探测器、废液管路传感器、阀门模块、储血罐称重装置、仪器护盖、触摸屏、推车组件组成，配合一次性使用分离器（型号CSE-P⁻⁷0，CSE-P-225，CSE-SQ-1000，CSE-B-1000）及储血罐（型号205）使用。
适用范围/预期用途
该产品适用于回收术中或术后伤口流出的血液，通过离心装置和洗涤程序处理血液，将处理过的红细胞产品泵入回输袋，由专业医务人员按照医院标准流程回输患者。“术前分离方案”用于分离术前自体富血小板血浆产品。
一、工作原理 (Working Principle)
中文采用离心式血液洗涤与分离技术，通过负压吸引收集术中 / 术后创面失血，同步加入肝素抗凝；经多层滤网初步过滤后，血液进入高速旋转离心杯（约 5600rpm），在离心力作用下红细胞沉降分层，血浆、游离血红蛋白、组织碎片、脂肪、抗凝剂等杂质作为废液分离排出；再以生理盐水反复冲洗红细胞层，去除残留杂质；浓缩红细胞（Hct 45%–65%）被泵入无菌回输袋，由医护人员回输患者，实现自体血闭环回收与再利用。EnglishAdopts centrifugal blood washing & separation technology. Surgical/postoperative blood is collected via negative-pressure aspiration with simultaneous heparin anticoagulation. After preliminary filtration, blood enters a high-speed centrifuge cup (~5600rpm); red blood cells (RBCs) sediment under centrifugal force, while plasma, free hemoglobin, tissue debris, fat, and anticoagulant are separated as waste. RBCs are thoroughly washed with normal saline to remove residual impurities. Finally, concentrated RBCs (Hct 45%–65%) are pumped into a sterile reinfusion bag for autologous transfusion, closing the loop of blood recovery.
二、产品功能 (Functions)
中文
术中全功能回收：支持洗涤式回收（标准模式）、非洗涤式快速回收（急救）、术前富血小板血浆（PRP）分离三模式。
全自动闭环处理：自动收集、抗凝、过滤、离心、洗涤、浓缩、回输，全程一键操作。
多场景适配：适配成人 / 儿童，支持术中、术后引流血（无污染）回收。
智能监测与报警：实时监测空气、压力、液位、废液量、离心状态，异常声光报警。
数据管理：10.4 英寸彩色触控屏，显示参数、曲线、日志；支持数据存储、打印、导出。
安全防护：空气探测器、防凝监测、漏液检测、双重门控，保障操作安全。
English
Full Intraoperative Recovery: Supports washed recovery (standard), unwashed rapid recovery (emergency), and preoperative PRP separation modes.
Fully Automated Closed-Loop Processing: One-touch operation for collection, anticoagulation, filtration, centrifugation, washing, concentration, and reinfusion.
Multi-Scenario Adaptation: For adult/pediatric use; recovers intraoperative & uncontaminated postoperative drainage blood.
Smart Monitoring & Alarms: Real-time air, pressure, level, waste volume, and centrifuge status monitoring with audible/visual alerts.
Data Management: 10.4" color touchscreen with parameters, curves, logs; data storage, print, export.
Safety Features: Air detector, anticoagulation monitor, leak detection, dual interlock doors.
三、产品特点 (Product Features)
中文
高效离心系统：5600rpm 高速离心，红细胞回收率≥90%，洗涤（游离 Hb＜0.1g/dL）。
双型号覆盖：CSE-E-CM（标准型）、CSE-EW-CM（带称重 / 废液监测增强型）。
一次性耗材：全封闭无菌一次性离心杯 / 管路，无交叉感染，即装即用。
触控智能操作：大尺寸触控屏，图形化界面，中文 / 英文切换，新手易上手。
便携稳定：一体化推车，静音脚轮，防震设计，适合手术室 / 急诊 / ICU 移动使用。
安全合规：符合 ISO 13485、IEC 60601、FDA、CE、NMPA 认证。
低噪节能：运行噪音≤65dB，功耗低，适合长时间手术。
English
High-Efficiency Centrifuge: 5600rpm high-speed; RBC recovery ≥90%, thorough washing (free Hb <0.1g/dL).
Dual Models: CSE-E-CM (standard), CSE-EW-CM (enhanced with weighing/waste monitoring).
Single-Use Consumables: Fully enclosed sterile disposable cups/tubing; no cross-contamination.
Touchscreen Smart Operation: Large touchscreen, graphical UI, CN/EN language, user-friendly.
Portable & Stable: Integrated cart, silent casters, shockproof; ideal for OR/ER/ICU mobility.
Regulatory Compliance: ISO 13485, IEC 60601, FDA, CE, NMPA certified.
Low Noise & Energy: ≤65dB during operation, low power for long surgeries.
四、技术参数 (Technical Specifications)
表格
参数项 (Item) 中文参数 (CN Spec) 英文参数 (EN Spec)
型号 (Model) CSE-E-CM（标准）、CSE-EW-CM（增强） CSE-E-CM (Standard), CSE-EW-CM (Enhanced)
离心转速 0–5600rpm（可调） 0–5600rpm (Adjustable)
处理能力 最大血流速度：1000mL/min；单次最大处理量：15L Max flow: 1000mL/min; Max volume: 15L
红细胞压积 洗涤后：45%–65%（可调） Post-wash: 45%–65% (Adjustable)
回收模式 洗涤式、非洗涤式、PRP 分离 Washed, Unwashed, PRP Separation
显示屏 10.4 英寸彩色 LCD 触控屏 10.4" Color LCD Touchscreen
负压范围 吸引负压：0–250mmHg（推荐＜150mmHg） Aspiration vacuum: 0–250mmHg (recommend <150mmHg)
清洗液 0.9% 生理盐水，用量：500–2000mL / 循环 0.9% NaCl; 500–2000mL/cycle
尺寸 (W×D×H) 主机：29.8×54.6×41.9cm；带推车：53.3×67.3×182.9cm Main unit: 29.8×54.6×41.9cm; With cart: 53.3×67.3×182.9cm
重量 主机：~25kg；推车：~18kg；总重：~43kg Main unit: ~25kg; Cart: ~18kg; Total: ~43kg
电源 100–240V AC, 50/60Hz, 600W 100–240V AC, 50/60Hz, 600W
工作环境 10–35℃，20%–80% RH（无冷凝） 10–35°C, 20%–80%RH (non-condensing)
注册证 国械注进 20183102464 NMPA Reg No.: 20183102464
制造商 美国 Haemonetics（唯美） Haemonetics Corporation, USA
五、使用方法 (Instructions for Use)
中文
术前准备
设备：开机自检，确认无报警；连接电源、废液袋、生理盐水、抗凝液（肝素 10–30U/mL）。
耗材：检查一次性离心杯 / 管路包装完好、在效期；按图示安装，确保管路无弯折、接口密封。
参数设置
选择模式：洗涤 / 非洗涤 / PRP；设定目标 Hct（45%–65%）、清洗液量、负压（＜150mmHg）。
血液收集
无菌吸引管连接术区，同步滴注抗凝剂（血：抗凝 = 5:1~7:1）；低负压吸引，避免红细胞破坏。
自动处理
启动程序：血液过滤→离心→分离废液→生理盐水洗涤→浓缩红细胞→泵入回输袋。
实时监测：观察曲线、压力、液位、废液量；异常报警立即暂停排查。
血液回输
双人核对：患者 ID、血袋标签、外观（暗红色、无浑浊）。
回输：使用标准输血器，前 15 分钟慢滴（1–2mL/min），监测生命体征。
术后处理
程序结束：自动排空、冲洗管路；取出一次性耗材，按医疗废物处置。
设备清洁：70% 酒精擦拭表面；定期维护（年度授权工程师）。
English
Preoperative Preparation
Device: Power on self-test; connect power, waste bag, saline, anticoagulant (heparin 10–30U/mL).
Consumables: Inspect sterile disposable cup/tubing; install per guide, no kinks, tight seals.
Parameter Setup
Select mode: washed/unwashed/PRP; set target Hct (45%–65%), wash volume, vacuum (<150mmHg).
Blood Collection
Sterile aspiration with simultaneous anticoagulant (blood:anticoag=5:1~7:1); low vacuum to prevent RBC damage.
Automatic Processing
Start cycle: filtration → centrifugation → waste separation → saline wash → RBC concentration → transfer to reinfusion bag.
Monitor: real-time curves, pressure, level, waste; pause on alarm.
Blood Reinfusion
Dual verification: patient ID, bag label, appearance (dark red, clear).
Infuse: standard blood tubing; slow initial rate (1–2mL/min ×15min), monitor vitals.
Postoperative Handling
Cycle end: auto-purge & flush; dispose consumables as medical waste.
Clean: 70% alcohol wipe; annual service by authorized tech.
六、适应症 (Indications)
中文
手术失血≥400mL：心血管、骨科（全髋 / 脊柱）、神经外科、肝脾、器官移植、泌尿外科大手术。
创伤 / 急救：肝脾破裂、大血管损伤、战伤、宫外孕破裂大出血。
特殊人群：稀有血型（Rh 阴性）、宗教禁忌异体输血、既往严重输血反应患者。
术后回收：胸腔 / 腹腔 / 关节术后无污染引流血（4 小时内）。
术前 PRP：骨科、整形手术富血小板血浆分离，促进愈合。
English
Surgical Blood Loss ≥400mL: cardiac, orthopedic (THA/spine), neurosurgery, hepatosplenic, transplant, urology.
Trauma/Emergency: liver/spleen rupture, major vascular injury, combat trauma, ectopic pregnancy hemorrhage.
Special Populations: rare blood types (Rh-), religious ｏbjections, history of severe transfusion reactions.
Postoperative Recovery: uncontaminated chest/abdominal/joint drainage (<4hrs).
Preoperative PRP: orthopedic/plastic surgery for healing enhancement.
七、禁忌症 (Contraindications)
中文
绝对禁忌
血液被细菌、脓液、粪便、胆汁、尿液、羊水严重污染。
术区含恶性肿瘤细胞（危及生命抢救除外）。
败血症、菌血症、全身感染。
血液流出血管外＞6 小时（开放性创伤＞4 小时）。
镰状细胞贫血、严重溶血、凝血因子缺乏症。
相对禁忌
心 / 肺 / 肝 / 肾功能不全、严重贫血、凝血功能障碍。
血液含骨水泥、局部止血药（明胶海绵、纤维胶）微粒。
English
Absolute Contraindications
Severe contamination with bacteria, pus, stool, bile, urine, amniotic fluid.
Malignant cells in surgical field (except life-threatening rescue).
Sepsis, bacteremia, systemic infection.
Blood extravasated >6hrs (open trauma >4hrs).
Sickle cell disease, severe hemolysis, coagulation factor deficiency.
Relative Contraindications
Cardiac/pulmonary/renal/hepatic insufficiency, severe anemia, coagulopathy.
Blood containing bone cement, topical hemostatic particles.
八、注意事项 (Precautions)
中文
无菌操作：全程无菌，耗材一次性使用，禁止复用；区分清洁 / 污染区。
抗凝规范：严格控制血：抗凝比例（5:1~7:1），避免凝固或抗凝过量。
负压控制：吸引负压＜150mmHg，减少红细胞损伤与溶血。
质量监测：洗涤后红细胞 Hct 45%–65%、游离 Hb＜0.1g/dL、无浑浊方可回输。
回输安全：4 小时内回输完毕；使用专用输血器；监测过敏、溶血、发热反应。
成分补充：洗涤血丢失血小板 / 凝血因子 / 血浆，大量回输需补充新鲜冰冻血浆、血小板。
设备维护：每日清洁；定期校准；年度由 Haemonetics 授权工程师维护。
人员资质：经培训合格医护人员操作，熟悉报警与应急处理。
English
Aseptic Technique: full sterile protocol; single-use consumables only; separate clean/contaminated areas.
Anticoagulation Control: strict ratio (5:1~7:1) to avoid clotting or excess anticoagulant.
Vacuum Limit: aspiration <150mmHg to minimize RBC damage/hemolysis.
Quality Check: post-wash Hct 45%–65%, free Hb <0.1g/dL, clear before reinfusion.
Transfusion Safety: complete infusion within 4hrs; use blood tubing; monitor reactions.
Component Replacement: washed blood lacks platelets/factors; replace with FFP/platelets for large volumes.
Device Maintenance: daily cleaning; periodic calibration; annual authorized service.
Qualified Staff: only trained personnel; familiar with alarms & emergencies.
九、存储条件 (Storage Conditions)
中文
设备存储
温度：-20℃～+55℃；湿度：20%–80% RH（无冷凝）。
环境：干燥、清洁、通风，远离腐蚀气体、强电磁、火源、直射阳光。
运输：防震包装，温度 - 40℃～+70℃，避免剧烈碰撞。
耗材存储
一次性离心杯 / 管路：密封包装，15℃–30℃室温保存，禁止冷冻。
有效期：包装标注 2 年；开封后立即使用。
English
Device Storage
Temp: -20°C to +55°C; Humidity: 20%–80%RH (non-condensing).
Environment: dry, clean, ventilated; away from corrosives, EMI, fire, sunlight.
Transport: shockproof packaging, -40°C to +70°C; avoid impact.
Consumables Storage
Disposable cups/tubing: sealed packaging, 15°C–30°C; do not freeze.
Shelf Life: 2 years per label; use immediately after opening.
十、说明书核心信息 (Manual Core Inｆormation)
中文
产品分类：三类医疗器械（血液处理 / 回收设备）。
型号：CSE-E-CM（标准）、CSE-EW-CM（增强型，带称重）。
组成：主机（离心、泵、阀、传感器、触控屏）、一体化推车、一次性耗材（离心杯、管路、回输袋）。
注册信息：国械注进 20183102464；制造商：Haemonetics Corp.（美国）。
标准：ISO 13485、IEC 60601-1/-2、FDA 510(k)、CE。
保修：主机1 年（不含耗材、人为损坏）。
使用权限：Rx ，医疗机构内专业医护人员操作。
废弃处理：一次性耗材按生物危害医疗废物处置；设备报废按电子医疗废物规范。
English
Classification: Class III Medical Device (blood processing/recovery system).
Models: CSE-E-CM (Standard), CSE-EW-CM (Enhanced with weighing).
Components: main unit (centrifuge, pumps, valves, sensors, touchscreen), cart, disposable kits (cup, tubing, bag).
Registration: NMPA Reg No. 20183102464; Manufacturer: Haemonetics Corp., USA.
Standards: ISO 13485, IEC 60601-1/-2, FDA 510(k), CE.
Warranty: 1 Year for main unit (excludes consumables, misuse).
Restriction: Rx only; for hospital use by trained medical staff.
Disposal: disposables as biohazard waste; device per e-waste regulations.
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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