厂家直供费森尤斯血液透析机6008
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厂家直供费森尤斯血液透析机6008
桂经理19117326863微xin同号
管理类别
第三类
型号规格
6008
结构及组成/主要组成成分
该产品由血泵、肝素泵、流量泵、负压泵、超滤泵、浓缩液泵、温度监控、压力监控、平衡监控、超滤监控、气泡监控、漏血监控和肝素泵监控组成。
适用范围/预期用途
该产品临床用于对40公斤及以上慢性肾功能不全患者进行血液透析（HD）或单纯超滤（ISOUF）治疗。
一、产品工作原理 / Operating Principle
中文
基于半透膜弥散、对流、超滤核心原理，结合 ** 高容量在线血液透析滤过（HDF）** 技术，通过双腔平衡腔容量控制，同步清除小分子毒素（尿素、肌酐）与中大分子毒素（β2 - 微球蛋白）。
体外循环：血泵驱动血液，肝素泵抗凝，多重压力 / 气泡 / 漏血监测保障安全。
透析液 / 置换液系统：反渗水 + 浓缩液配比，DIASAFE Plus 滤除微生物 / 内毒素，在线生成超纯置换液Fresenius Medical Care。
智能控制：一体化闭环反馈，自动调节血流量、超滤率、置换液量，维持血流动力学稳定。
English
Based on semipermeable membrane diffusion, convection, ultrafiltration, combined with high-volume online hemodiafiltration (HDF). Dual-chamber balance enables precise volume control, removing small (urea, creatinine) and middle-large molecules (β2-microglobulin).
Extracorporeal Circuit: Blood pump, heparin pump, multi-pressure/air/blood leak monitoring.
Dialysate/Substitute: RO water + concentrate; DIASAFE Plus for ultrapure fluid; online substitutionFresenius Medical Care.
Smart Control: Closed-loop feedback, auto-adjust blood/UF/substitution flow for hemodynamic stability.
二、产品功能 / Functions
中文
标准血液透析（HD）：常规小分子毒素清除与容量管理
高容量在线血液透析滤过（HV-HDF）：中大分子高效清除，降低死亡风险
血液滤过（HF）/ 单纯超滤（IUF）：单纯脱水或对流为主治疗
在线清除监测（OCM）：实时 Kt/V、尿素清除率，评估透析充分性Fresenius Medical Care
智能容量管理（BVM）：血容量监测，自动调节超滤，防低血压Fresenius Medical Care
血液温度控制（BTM）：控温（35–39℃），提升舒适度Fresenius Medical Care
血管通路监测（VAM）：静脉通路实时监控，防凝血 / 渗血Fresenius Medical Care
全自动消毒：热消毒（85–95℃）、化学 / 柠檬酸消毒Fresenius Medical Care
一体化管路（CAREset）：预连接、RFID 识别、一键预充 / 回血
数据管理：治疗记录、联网传输、报表生成Fresenius Medical Care
English
Standard Hemodialysis (HD): Small solute clearance & volume control
High-Volume Online HDF (HV-HDF): Superior middle-large molecule removal, reduced mortality
Hemofiltration (HF)/Isolated Ultrafiltration (IUF): Fluid removal or convection-dominant therapy
Online Clearance Monitor (OCM): Real-time Kt/V, urea clearance, adequacy assessmentFresenius Medical Care
Blood Volume Monitor (BVM): Auto-adjust UF, prevent hypotensionFresenius Medical Care
Blood Temperature Monitor (BTM): Precise 35–39°C control, enhanced comfortFresenius Medical Care
Vascular Access Monitor (VAM): Real-time venous access monitoringFresenius Medical Care
Auto Disinfection: Heat (85–95°C), chemical, citric acidFresenius Medical Care
CAREset Integrated Tubing: Pre-connected, RFID, 1-click prime/return
Data Management: Therapy logging, network, reportingFresenius Medical Care
三、产品特点 / Features
中文
旗舰级 HV-HDF：置换液最高 36L / 次，中大分子清除提升 40%+
一体化 CAREset 管路：红点设计奖，预连接、少操作、低感染风险
超纯透析液：DIASAFE Plus（0.1µm），内毒素＜0.03EU/mLFresenius Medical Care
全闭环智能控制：自动钠 / 超滤 / 温度曲线，血流动力学更稳
极简操作：一键预充 / 消毒 / 回血，医护效率提升 50%
多重安全防护：VAM 通路监测、紧急键、10 + 项报警联动Fresenius Medical Care
节能 EcoFlow：透析液流量智能调节，节水 30%+Fresenius Medical Care
模块化扩展：BPM/BVM/BTM/VAM 可选，适配全场景
临床验证：降低 23% 死亡风险，心血管事件显著减少
English
Flagship HV-HDF: Up to 36L substitution/session, 40%+ higher middle-large clearance
Integrated CAREset: Red Dot Design Award, pre-connected, low infection risk
Ultrapure Fluid: DIASAFE Plus (0.1µm), endotoxin <0.03EU/mLFresenius Medical Care
Closed-Loop Smart Control: Auto sodium/UF/temp profiles, stable hemodynamics
Minimal Operation: 1-click prime/disinfect/return, 50% higher efficiency
Multi-Level Safety: VAM, emergency key, 10+ alarmsFresenius Medical Care
EcoFlow: Smart dialysate flow, 30%+ water savingFresenius Medical Care
Modular: BPM/BVM/BTM/VAM options, full adaptability
Clinical Proof: 23% lower mortality, fewer cardiovascular events
四、技术参数 / Technical Specifications
中文
尺寸 / 重量：1600×600×750mm；约 95kgFresenius Medical Care
血泵流量：30–600mL/min（±5mL/min）Fresenius Medical Care
肝素泵：0.5–10.0mL/h；推注 1–20mLFresenius Medical Care
透析液流量：300–1000mL/minFresenius Medical Care
超滤范围：0–6000mL/h；精度 ±0.5%Fresenius Medical Care
置换液流量：0–800mL/min（HV-HDF 最高 36L / 次）
温度：35.0–39.0℃（±0.1℃）Fresenius Medical Care
电导度：12.0–16.0mS/cmFresenius Medical Care
消毒：热消毒（85–95℃）、化学、柠檬酸Fresenius Medical Care
电源：AC 100–240V±10%，50/60Hz，8A（230V）Fresenius Medical Care
备用电池：≥45min（断电安全回血）Fresenius Medical Care
English
Dimensions/Weight: 1600×600×750mm; ~95kgFresenius Medical Care
Blood Flow: 30–600mL/min (±5mL/min)Fresenius Medical Care
Heparin Pump: 0.5–10.0mL/h; bolus 1–20mLFresenius Medical Care
Dialysate Flow: 300–1000mL/minFresenius Medical Care
Ultrafiltration: 0–6000mL/h; ±0.5% accuracyFresenius Medical Care
Substitution Flow: 0–800mL/min (max 36L/session HV-HDF)
Temperature: 35.0–39.0°C (±0.1°C)Fresenius Medical Care
Conductivity: 12.0–16.0mS/cmFresenius Medical Care
Disinfection: Heat (85–95°C), chemical, citric acidFresenius Medical Care
Power: AC 100–240V±10%, 50/60Hz, 8A (230V)Fresenius Medical Care
Battery Backup: ≥45min (safe return)Fresenius Medical Care
五、使用方法（核心步骤）/ Usage (Key Steps)
中文
开机自检：通电自动自检（约 8min），通过后方可使用
管路安装：安装一体化 CAREset 管路，RFID 自动识别
一键预充：启动自动预冲，排尽空气、冲洗管路 / 透析器
参数设置：治疗模式（HD/HV-HDF）、时间、血流量、超滤量、肝素
患者连接：无菌操作，连接动静脉通路，启动治疗
智能监测：系统自动调节参数，监测压力、容量、温度
一键回血：治疗结束，自动回血、分离管路
自动消毒：启动热 / 化学消毒，完成后待机
日常维护：每日清洁、每周滤芯更换、定期校准
English
Power-On Self-Test: Auto-test (~8min), only proceed if passed
Tubing Setup: Install CAREset, RFID auto-identification
1-Click Prime: Auto-prime, deaerate, flush circuit
Parameter Setting: Mode (HD/HV-HDF), time, blood/UF/heparin
Patient Connect: Aseptic connection, start therapy
Smart Monitoring: Auto-adjust parameters, pressure/volume/temp tracking
1-Click Return: Auto-blood return, disconnect
Auto-Disinfection: Heat/chemical disinfection, standby
Maintenance: Daily clean, weekly filter change, periodic calibration
六、适应症 / Indications
中文
急性 / 慢性肾功能衰竭（终末期肾病）
高容量血液透析滤过（HV-HDF）适应证：中大分子毒素蓄积、心血管不稳定
急性药物 / 毒物中毒（可透析性毒物）
严重电解质紊乱、酸碱失衡
容量超负荷（急性肺水肿、难治性心衰）
尿毒症并发症（高钾血症、代谢性酸中毒）
适用人群：40kg 及以上患者
English
Acute/chronic renal failure (ESRD)
HV-HDF: Middle-large molecule accumulation, hemodynamic instability
Acute drug/toxin intoxication (dialyzable)
Severe electrolyte/acid-base imbalance
Volume overload (acute pulmonary edema, refractory heart failure)
Uremia complications (hyperkalemia, ｍmbedbolic acidosis)
Population: Patients ≥40kg
七、禁忌症 / Contraindications
中文
严重休克 / 顽固性低血压（SBP＜90mmHg，升压药无效）
严重活动性出血（颅内、消化道、咯血等）
无法建立有效血管通路
严重心肌病变伴难治性心衰
恶性肿瘤晚期恶病质（生存期＜1 个月）
精神障碍无法配合治疗
患者 / 家属明确拒绝治疗
English
Severe shock/refractory hypotension (SBP <90mmHg, unresponsive to pressors)
Severe active bleeding (intracranial, GI, hemoptysis)
Inability to establish vascular access
Severe cardiomyopathy with refractory heart failure
Advanced malignancy with cachexia (survival <1 month)
Psychiatric disorders precluding cooperation
Patient/family refusal
八、注意事项 / Warnings & Precautions
中文
专业操作：经培训医护人员使用
自检必须通过：自检失败严禁治疗
无菌操作：严格执行，预防感染
抗凝个体化：评估出血风险，调整肝素 / 无肝素方案
报警立即处理：声光报警时停机排查
耗材合规：仅用原厂 CAREset 及注册透析器
电气安全：接地良好、防潮、防溅水Fresenius Medical Care
儿童 / 重症监护：需专人监护，参数调控
定期维护：按说明书校准、更换部件
English
Qualified Staff Only: Trained medical personnel
Pass Self-Test: No therapy if failed
Aseptic Technique: Strict infection control
Individualized Anticoagulation: Assess bleeding risk, adjust heparin-free
Immediate Alarm Response: Stop on alarm
Approved Consumables: Only original CAREset & registered dialyzers
Electrical Safety: Proper grounding, moisture protectionFresenius Medical Care
Pediatric/ICU: Supervised, precise parameter control
Regular Maintenance: Calibration & part replacement
九、存储条件 / Storage Conditions
中文
环境温度：5–40℃Fresenius Medical Care
相对湿度：≤80%（无冷凝）Fresenius Medical Care
大气压力：700–1060hPaFresenius Medical Care
环境：清洁、干燥、通风、无腐蚀性气体 / 粉尘Fresenius Medical Care
运输：防剧烈震动、防潮、防雨淋、防暴晒Fresenius Medical Care
长期存储：断电、清洁干燥、定期检查（每 3 个月）Fresenius Medical Care
English
Ambient Temp: 5–40°CFresenius Medical Care
Relative Humidity: ≤80% (non-condensing)Fresenius Medical Care
Atmospheric Pressure: 700–1060hPaFresenius Medical Care
Environment: Clean, dry, ventilated, no corrosive gas/dustFresenius Medical Care
Transport: Shock/moisture/rain/sun protectionFresenius Medical Care
Long-Term Storage: Power off, clean/dry, check every 3 monthsFresenius Medical Care
十、说明书核心信息 / Manual Core Summary
中文
注册证：国械注进 20233100055（进口）、国械注准 20253102156（国产）
型号：6008 CAREsystem
生产：德国 Fresenius / 江苏费森尤斯
软件版本：V1.0+Fresenius Medical Care
安全标准：IEC 60601-1/-2，GB 9706.1Fresenius Medical Care
预期用途：急性 / 慢性肾衰、中毒、电解质紊乱的 HD/HV-HDF/HF/IUF 治疗
使用寿命：注册证 5 年；设备正常维护可用 10–12 年Fresenius Medical Care
核心优势：高容量 HDF、一体化管路、智能闭环、极简操作、临床获益显著
English
Registration: Import 20233100055; Domestic 20253102156
Model: 6008 CAREsystem
Manufacture: Fresenius (Germany) / Jiangsu Fresenius (China)
Software: V1.0+Fresenius Medical Care
Safety: IEC 60601-1/-2, GB 9706.1Fresenius Medical Care
Intended Use: HD/HV-HDF/HF/IUF for renal failure, intoxication, electrolyte disorders
Lifespan: Registration 5 years; 10–12 years with maintenanceFresenius Medical Care
Key Advantages: HV-HDF, integrated tubing, closed-loop, minimal steps, proven clinical benefits
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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