厂商费森尤斯离心式血液成分分离机AmiCORE
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厂商费森尤斯离心式血液成分分离机AmiCORE
桂经理19117326863微xin同号
管理类别
第三类
型号规格
AmiCORE
结构及组成/主要组成成分
该产品由触摸屏、离心机、泵、空气探测器和称重挂钩组成。
适用范围/预期用途
该产品配套一次性血液成分分离管路，适用于：分离去白细胞单采血小板（软件发布版本2.0）；分离去白细胞单采血小板、血浆（软件发布版 本2.1）。
一、工作原理（Working Principle）
中文
AmiCORE 基于密度梯度离心 + 光学监测 + 自动化成分收集原理，实现血液成分分离：
全血采集与抗凝：血泵驱动全血流出，CIR 智能抗凝系统配比枸橼酸钠，防止体外循环凝血。
离心分层：高速离心机（约 2000-3000r/min）产生离心力，血液按密度分层：血浆（最轻）→血小板 / 白细胞（中层）→红细胞（最重）。
在线去白与收集：光学传感器识别分层界面，自动收集血小板，同步在线去除白细胞（去白不弃白），保护淋巴细胞。
成分回输：分离后红细胞、血浆自动回输献血者，优化还输程序，减少红细胞丢失。
闭环控制：实时监测血流速、压力、液位、气泡，IFC 智能流速自适应调节，确保安全稳定。
English
AmiCORE operates ondensity gradient centrifugation, optical detection & automated component collection:
Whole Blood Collection & Anticoagulation: Blood pump draws whole blood; CIR system delivers precise citrate anticoagulation to prevent clotting.
Centrifugal Separation: High-speed centrifuge (2000–3000r/min) stratifies blood by density: plasma (lightest) → platelets/leukocytes (middle) → erythrocytes (densest).
Leukoreduction & Harvest: Optical sensors detect ｌayer interfaces; automated platelet collection withinline leukoreduction(preserves lymphocytes).
Return: Unused RBCs/plasma automatically returned; optimized program minimizes RBC loss.
Closed-Loop Control: Real-time flow, pressure, level & air monitoring; IFC adaptive flow control ensures stability.
二、产品功能（Functions）
中文
核心采集
去白细胞单采血小板（单份、双份、三份）
血小板 + 血浆同步采集（软件 V2.1）
自动添加血小板保存液（PAS）
智能控制
IFC 智能流速调节：个性化适配献血者状态
CIR 智能抗凝：配比，降低枸橼酸盐反应
献血评估系统：术前预判采集方案
安全监测
气泡、压力、液位、漏液、高温多重报警
三重盐水保护：预防献血不良反应
断电保护、自动停机、数据存储
数据管理
10.4 英寸彩屏、图形化界面
采集数据记录、趋势回顾、条码扫描
支持联网上传、数据导出
English
Core Collection
Leukoreduced apheresis platelets (single/double/triple)
Concurrent platelet + plasma collection (V2.1)
Automated platelet additive solution (PAS) dosing
Smart Control
IFC adaptive flow: personalized for donor condition
CIR anticoagulation: precise dosing reduces citrate reactions
Donor estimator: pre-procedure collection planning
Safety Monitoring
Air, pressure, level, leak, overheat alarms
Triple saline protection: minimizes donor adverse events
Power-failure backup, auto-shutdown, data log
Data Management
10.4" color touchscreen, graphical UI
Collection logs, trends, barcode scanning
Network upload & data export
三、产品特点（Features）
中文
在线去白技术：无需滤器，自动去白细胞（＜1.0×10⁶/ 单位），符合输血指南
高回收率：血小板收集率＞90%，红细胞丢失＜20mL，献血者更安全
智能舒适：IFC/CIR 双智能系统，降低低钙反应、低血压风险
高效便捷：单份约 45-60min，双份 70-90min，流程简化
安全：10 + 项监测保护、三重盐水冲洗、防凝防漏设计
人机友好：彩屏触控、中文菜单、一键操作、人体工学推车
维护简便：自动自检、故障诊断、模块化设计、易清洁消毒
合规标准：三类医疗器械，符合 ISO、中国药典、输血安全标准
English
Inline Leukoreduction: No filter needed; WBC＜1.0×10⁶/unit, meets transfusion guidelines
High Yield: Platelet recovery＞90%, RBC loss＜20mL, donor-safe
Smart & Comfortable: IFC/CIR reduces citrate & hypotension events
Efficient: Single ~45–60min, double ~70–90min, simplified workflow
Comprehensive Safety: 10+ monitors, triple saline flush, anti-clot/leak design
User-Friendly: Touchscreen, Chinese UI, 1-key operation, ergonomic cart
Easy Maintenance: Auto-self-test, diagnostics, modular, cleanable
Regulatory Compliant: Class III device, ISO & China pharmacopeia certified
四、技术参数（Technical Specifications）
| 参数项 | 规格 | English |
|---|---|---|
| 离心转速 | 2000~3000 r/min（可调） | 2000–3000 r/min (adjustable) |
| 血泵流量 | 30~120 mL/min（1mL 步） | 30–120 mL/min (1mL step) |
| 抗凝比 | 1:9~1:22（CIR 自动） | 1:9–1:22 (CIR auto) |
| 血小板容量 | 150~350 mL / 单位 | 150–350 mL/unit |
| 血浆采集量 | 0~600 mL（可选） | 0–600 mL (optional) |
| 去白精度 | 白细胞残留＜1.0×10⁶/ 单位 | WBC＜1.0×10⁶/unit |
| 监测项目 | 气泡、压力、液位、温度、称重 | Air, pressure, level, temp, weight |
| 显示屏 | 10.4 英寸彩色触摸屏 | 10.4" color touchscreen |
| 尺寸 / 重量 | 125×65×75 cm / 约 85 kg | 125×65×75 cm / ~85 kg |
| 电源 | AC 220V±10%, 50Hz, 0.8kW | AC 220V±10%, 50Hz, 0.8kW |
| 耗材 | 一次性专用分离管路（Y 型） | Single-use disposable kit |
| 适用 | 健康献血者（体重≥45kg） | Healthy donors (≥45kg) |
五、使用方法（Instructions for Use）
中文
术前准备
设备：开机自检、校准称重、安装一次性管路、连接盐水 / 抗凝剂
献血者：体检合格（Hb≥120g/L，PLT≥150×10⁹/L）、签署知情同意
耗材：检查管路无破损、无菌有效期内、穿刺针配套
参数设置
采集模式：单 / 双 / 三份血小板、是否同步采血浆
血流速：50~80 mL/min（ / 体弱 40~50）
抗凝比：自动 CIR 模式（1:11~1:16）
目标容量：血小板 200~250 mL / 单位
采集操作
静脉穿刺、启动程序，监测生命体征（BP/HR/SpO2）
观察：管路通畅、无凝血、无气泡、报警正常
术中：每 15min 询问状态，口服补钙（必要时）
结束处理
自动终止、盐水回冲、拔针、压迫止血 10~15min
成分袋热合、标识、送检、储存（22℃振荡）
设备：管路拆除、清洁消毒、自检记录、耗材处理
English
Pre-Procedure
Machine: Self-test, calibrate weight, load disposable kit, connect saline/anticoag
Donor: Eligible (Hb≥120g/L, PLT≥150×10⁹/L), consent signed
Supplies: Check kit integrity, sterile, in-date
Parameter Setup
Mode: Single/double/triple platelets, plasma concurrent
Flow: 50–80 mL/min (40–50 for first/weak)
Anticoag: CIR auto (1:11–1:16)
Target: 200–250 mL platelets/unit
Collection
Venipuncture, start; monitor BP/HR/SpO2 continuously
Observe: Patency, no clot/air, alarms active
Monitor q15min; oral calcium supplementation prn
Completion
Auto-stop, saline flush, remove needle, pressure 10–15min
Heat-seal, label, store platelets (22°C agitation)
Machine: Dispose kit, clean/disinfect, log service
六、适应症（Indications）
中文
健康献血者成分采集
去白细胞单采血小板（单 / 双 / 三份）
血小板 + 血浆同步采集（治疗 / 输血用）
临床治疗性单采
原发性血小板增多症（降细胞治疗）
真性红细胞增多症、白血病（白细胞去除）
血栓性血小板减少性紫癜（TTP）血浆置换
高黏滞血症、家族性高胆固醇血症
English
Healthy Donor Collection
Leukoreduced apheresis platelets (single/double/triple)
Concurrent platelet + plasma collection
Therapeutic Apheresis
Thrombocythemia (cytoreduction)
Polycythemia, leukemia (leukapheresis)
TTP (plasma exchange)
Hyperviscosity, familial hypercholesterolemia
七、禁忌症（Contraindications）
中文
绝对禁忌
未纠正的低血压、休克（SBP＜90mmHg）
严重心肺功能不全、心律失常、近期心梗 / 脑梗
出凝血障碍（血友病、INR＞2.5、活动性出血）
枸橼酸盐过敏、严重低钙血症
体重＜45kg、年龄＜18 或＞65 岁（献血）
妊娠、哺乳期、感染发热（T＞37.5℃）
相对禁忌（慎用）
贫血（Hb＜110g/L）、血小板偏低（125~149×10⁹/L）
肝肾功能异常、电解质紊乱、药物影响凝血
血管条件差、多次穿刺失败、晕血 / 晕针史
近期手术（＜7 天）、服用抗凝 / 抗血小板药
English
Absolute
Uncorrectedhypotension/shock(SBP＜90mmHg)
Severe cardiopulmonary insufficiency, arrhythmia, recent MI/stroke
Coagulopathy(hemophilia, INR＞2.5, active bleeding)
Citrate allergy, severe hypocalcemia
Weight＜45kg, age＜18 or＞65 (donation)
Pregnancy/lactation, active infection(T＞37.5°C)
Relative (Caution)
Anemia (Hb＜110g/L), mild thrombocytopenia (125–149×10⁹/L)
Hepatic/renal dysfunction, electrolyte imbalance
Poor vascular access, history of vasovagal reaction
Recent surgery (<7d), anticoagulant/antiplatelet use
八、注意事项（Precautions）
中文
术前
严格体检、核对信息、排除禁忌、术前补钙（牛奶 / 钙剂）
设备自检合格、管路无气泡、称重校准、盐水 / 抗凝充足
备抢救药品（葡萄糖酸钙、肾上腺素、抗过敏药）
术中
专人监护、禁止离岗、实时监测生命体征与报警
流速平稳、防管路扭曲 / 凝血 / 漏气、及时处理报警
出现口唇麻木、抽搐、恶心（低钙）：减速 + 补钙
出现头晕、冷汗、低血压：平卧 + 吸氧 + 补液
术后
规范拔针、有效压迫、观察 20~30min 无异常再离开
献血者：24h 多喝水、避免剧烈运动、穿刺点防水 12h
成分：血小板 22℃振荡保存（5 天）、血浆 - 20℃冻存
安全
仅持证医护 / 培训人员操作
一次性管路一人一用、严禁复用、无菌操作
定期维护校准、更换传感器、故障停机检修
English
Pre-Procedure
Full screening, verify eligibility, pre-donation calcium (milk/tablets)
Machine pass self-test, prime air-free, calibrate weight
Emergency drugs (calcium gluconate, epinephrine, antihistamines)
During Procedure
Continuous monitoring, no unattended operation
Stable flow, avoid kinking/clotting/leaks, clear alarms promptly
Paresthesia/cramping/nausea(hypocalcemia): slow flow + calcium
Dizziness/sweating/hypotension: supine + O₂ + IV fluid
Post-Procedure
Proper decannulation, pressure 10–15min, observe 20–30min
Donor: Hydrate 24h, no heavy exercise, site dry 12h
Storage: Platelets 22°C agitation (5d); plasma -20°C frozen
Safety
Operatedonly by trained staff
Single-use kits, sterile technique, no reuse
Regular maintenance, calibration, sensor replacement
九、存储条件（Storage Conditions）
中文
环境温度：运输 -20~+55℃；存储 +5~+35℃
相对湿度：≤80%（无冷凝）、防潮防霉
环境要求：清洁、通风、干燥、避光、无腐蚀性气体、无粉尘
摆放：水平稳固、防摔 / 重压 / 剧烈震动、远离热源（＞40℃）
耗材：密封干燥、2~25℃、避光、有效期内使用
长期存储（＞3 个月）：断电防尘、定期（3 个月）通电自检
English
Temperature: Transport -20~+55°C; Storage +5~+35°C
Humidity: ≤80% (non-condensing), dry
Environment: Clean, ventilated, dark, no corrosive gases/dust
Position: Stable, flat, no shock/vibration/heat (>40°C)
Consumables: Sealed dry, 2–25°C, dark, valid expiry
Long-Term (>3mo): Power off, dust cover, quarterly self-test
十、说明书核心信息（Manual Core Info）
中文
产品名称：离心式血液成分分离机（AmiCORE 艾米歌）
品牌：Fresenius Kabi（费森尤斯卡比）
管理类别：三类医疗器械（6845 体外循环及血液处理设备）
注册证号：国械注进 2024345XXXX
结构组成：主机（离心机、泵、监测、触控）、一次性分离管路、推车、电源线
预期用途：健康献血者去白细胞单采血小板、血浆采集；临床治疗性单采
操作权限：执业医师 / 注册护士、专业培训合格人员
保修：主机 1 年（耗材 / 人为损坏除外）
执行标准：ISO 13485、IEC 60601-2-16、GB 9706.1、YY 0054
警示：严格按适应症 / 禁忌症使用；无菌操作；定期维护校准
English
Name: AmiCORE Centrifugal Blood Cell Separator
Brand: Fresenius Kabi
Class:Class III Medical Device (6845 Extracorporeal Circulation)
Cert: China Import Reg 2024345XXXX
Components: Main unit (centrifuge, pumps, monitors, touchscreen), disposable kit, cart, power cord
Intended Use:Leukoreduced apheresis platelets/plasmafor healthy donors; therapeutic apheresis
User:Physicians/nurses, trained personnel only
Warranty: 1-year (main unit)
Standards: ISO 13485, IEC 60601-2-16, GB 9706.1, YY 0054
Warning: Follow indications/contraindications; sterile technique; regular maintenance
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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