厂家供应费森尤斯血液透析机4008A
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厂家供应费森尤斯血液透析机4008A
桂经理19117326863微xin同号
管理类别
第三类
型号规格
4008A
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、工作原理（Working Principle）
中文
4008A 通过血液体外循环与透析液供给双系统协同，模拟肾脏滤过功能：
血液循环：血泵驱动血液经管路进入透析器；肝素泵持续抗凝；压力 / 气泡 / 漏血监测全程监控，异常时自动停泵、夹闭静脉管路。
透析液制备：反渗水经加热、除气，与 A/B 浓缩液在双容量平衡腔定容混合（1:34.5），经 DIASAFEplus 滤除细菌 / 内毒素，生成超纯透析液。
溶质交换：血液与透析液在透析器半透膜两侧逆向流动，弥散清除小分子毒素（尿素 / 肌酐），对流 / 超滤脱水并清除中分子物质。
容量控制：平衡腔精确计量透析液进出量，按设定 ** 超滤率（UFR）** 脱水，误差≤±50mL。
安全闭环：全程监测电导、温度、压力、气泡、漏血，多重声光报警 + 自动保护，断电时 15 分钟电池续航。
English
Operates via two integrated systems mimicking renal function:
Blood Circuit: Blood pump drives flow; heparin pump anticoagulates; pressure/air/blood leak monitors trigger auto-stop/clamp on anomaly.
Dialysate Generation: RO water heated/degassed, mixed with A/B concentrates in dual-chamber balance system (1:34.5); DIASAFEplus filter produces ultrapure dialysate.
Solute Exchange: Counter-current flow across dialyzer membrane; diffusion clears small toxins (urea/creatinine); convection/ultrafiltration removes fluid & middle molecules.
Fluid Control: Balance chambers meter inflow/outflow; precise UF control (error ≤±50mL) per prescribed rate.
Safety: Continuous monitoring (conductivity/temp/pressure/air/leakage); alarms + auto-protection; 15-min battery backup.
二、核心功能（Core Functions）
表格
中文功能 English Function
血液透析（HD）：弥散清除毒素、纠正电解质 / 酸碱紊乱 Hemodialysis (HD): Diffusive toxin removal, electrolyte/acid-base balance
单纯超滤（ISO-UF）：仅脱水、不弥散，适用于严重水肿 / 心衰 Isolated Ultrafiltration (ISO-UF): Fluid removal only, for severe edema/heart failure
超滤：双腔定容，脱水误差≤±50mL，实时显示累计脱水量 Precise Ultrafiltration: Dual-chamber metering, ≤±50mL error, real-time UF volume
超纯透析：DIASAFEplus 滤器，内毒素＜0.03EU/mL、细菌＜0.1CFU/mL Ultrapure Dialysate: DIASAFEplus, endotoxin＜0.03EU/mL, bacteria＜0.1CFU/mL
多参数监测：动脉压 / 静脉压 / 跨膜压、电导、温度、气泡、漏血 Multi-Parameter Monitoring: ART/VEN/TMP, conductivity, temp, air, blood leak
自动消毒：热化学（76.3–90℃）、柠檬酸、热水消毒，一键全自动 Auto-Disinfection: Thermal-chemical (76.3–90°C), citric acid, hot water
安全保护：气泡 / 漏血 / 压力异常时自动停泵、夹闭静脉、报警 Safety Protection: Auto-stop/clamp/alarm on air/leak/pressure faults
触屏操作：10.4 英寸彩色触屏，参数设置 / 数据记录 / 报警查询直观 Touchscreen: 10.4" color display, intuitive setup/data/logs
断电续航：内置电池，停电维持 15 分钟安全运行 Power Backup: 15-min battery support during outage
三、产品特点（Product Features）
中文
经典双平衡腔技术：费森尤斯专利，定容式混合，透析液精度 ±1%，超滤稳定。
标配超纯系统：DIASAFEplus 内置滤器，全程超纯透析，保护残余肾功能、降低微炎症。
高可靠安全设计：12 项安全监测、三级报警、自动保护、断电续航，25 年临床验证。
直观智能操作：彩色触屏、图形化界面、流程引导、故障自诊断、数据存储≥1000 例。
紧凑节能：体积小（149×63×80cm）、重量轻（≈100kg）、功耗低（0.59kW），适合基层 / 移动透析。
维护简便：模块化设计、自动消毒、耗材寿命提示、故障代码清晰、维修成本低。
治疗兼容：适配高通量 / 低通量透析器、碳酸氢盐透析、单超，满足基础与强化治疗。
合规认证：CE、FDA、NMPA 认证，符合 ISO 13485，全球通用。
English
Patented Dual Balance Chambers: Volumetric mixing, ±1% dialysate accuracy, stable UF control.
Standard Ultrapure System: DIASAFEplus filter, full ultrapure treatment, preserves RKF & reduces inflammation.
Proven Safety: 12 monitors, 3-level alarms, auto-protection, 15-min battery; 25+ years clinical trust.
Intuitive Interface: Color touchscreen, graphical workflow, self-diagnosis, 1000+ treatment logs.
Compact & Efficient: Small footprint (149×63×80cm), 100kg, 0.59kW consumption; ideal for clinics.
Low Maintenance: Modular design, auto-disinfection, consumable alerts, clear fault codes.
Versatile Therapy: HD/ISO-UF, bicarbonate, high/low-flux dialyzers.
Certified: CE, FDA, NMPA, ISO 13485 approved.
四、技术参数（Technical Specifications）
| 参数项（中） | Parameter (En) | 规格 ||---|---|| 型号 | Model | 4008A || 血流量 | Blood Flow | 50–600 mL/min（步进 1mL/min） || 透析液流量 | Dialysate Flow | 300/500 mL/min（可切换） || 超滤范围 | UF Volume | 0–9999 mL || 超滤率 | UF Rate | 0–4000 mL/h（步进 1mL/h） || 透析液温度 | Temp | 35.0–39.0℃（精度 ±0.5℃） || 电导范围 | Conductivity | 12.0–15.7 mS/cm（精度 ±0.1 mS/cm） || 平衡精度 | Balance Accuracy | ≤±50 mL / 治疗 || 血泵 | Blood Pump | 滚轮式，流量精确可控 || 肝素泵 | Heparin Pump | 0.1–9.9 mL/h，累计 0.1–99.9mL || 气泡监测 | Air Detector | 超声波，≥50µm 气泡报警 / 停泵 || 漏血监测 | Blood Leak | 光学，阈值≤0.35mL/min || 消毒方式 | Disinfection | 热化学 / 柠檬酸 / 热水（76.3–90℃） || 超纯系统 | Ultrapure | DIASAFEplus 滤器（标配） || 显示屏 | Display | 10.4 英寸彩色 LCD 触屏 || 电源 | Power | 220V±10%, 50/60Hz, 0.59kW || 电池续航 | Battery | 15 分钟（停电维持） || 尺寸 / 重量 | Dimensions/Weight | 149×63×80cm / ≈100kg || 适用患者 | Patient | ≥40kg 慢性肾功能不全 || 灭菌 / 有效期 | Sterility/Shelf Life | 设备复用，定期消毒；主机质保 2 年 |
五、使用方法（Usage Instructions）
中文
1. 术前准备
开机自检（T1 测试），确认无故障、耗材在有效期。
安装 A/B 液管路、透析器、血路管，连接反渗水、电源、废液管。
触屏设置：治疗模式（HD / 单超）、血流量、透析液流量、超滤量 / 率、温度、肝素。
自动预冲：管路→透析器→静脉壶，排气、测压、漏血测试。
2. 治疗操作
患者穿刺（内瘘 / 中心静脉），连接动脉管路，启动血泵（50mL/min 起步）。
回血确认后，调至目标血流量，开启透析液、超滤、肝素泵。
监测：每 30 分钟记录血压、心率、静脉压、跨膜压、超滤量；观察穿刺口、管路、透析器。
报警处理：按提示排查（气泡 / 压力 / 漏血 / 电导），异常时停泵、夹闭、回血。
3. 治疗结束
停超滤、透析液，血泵调至 100mL/min，生理盐水回血（200–300mL）。
拔针、压迫止血，分离管路，关机。
自动消毒：选择热化学 / 柠檬酸，一键执行，完成后待机。
4. 维护
每日：消毒、表面清洁、检查漏水、耗材更换。
每周：电导 / 温度校准、滤网清洗、电池测试。
每月：平衡腔测试、漏血 / 气泡监测校验、安全功能检测。
English
1. Pre-Treatment
Power on & run T1 self-test; confirm no faults, valid consumables.
Install A/B lines, dialyzer, blood lines; connect RO water, power, drain.
Touchscreen setup: mode (HD/UF), blood/dialysate flow, UF volume/rate, temp, heparin.
Auto-prime: lines → dialyzer → venous chamber; purge air, pressure/leak test.
2. Treatment
Cannulate patient (fistula/central line); connect arterial line; start pump (50mL/min).
Adjust to target flow; enable dialysate, UF, heparin once blood returns.
Monitor: BP, HR, VEN, TMP, UF q30min; check site, lines, dialyzer.
Alarm response: troubleshoot per code; stop/clamp/return blood if critical.
3. Termination
Stop UF/dialysate; slow pump to 100mL/min; saline return (200–300mL).
Remove needle, apply pressure; disconnect lines; power off.
Auto-disinfect: thermal-chemical/citric acid; one-key cycle.
4. Maintenance
Daily: Disinfect, clean, inspect leaks, replace consumables.
Weekly: Calibrate conductivity/temp, clean filters, test battery.
Monthly: Balance test, leak/air check, safety function verify.
六、适应症（Indications）
中文
慢性肾功能衰竭（ESRD）：≥40kg 患者维持性血液透析。
急性肾损伤（AKI）：少尿 / 无尿、毒素蓄积、电解质紊乱。
严重水肿 / 心衰：单纯超滤（ISO-UF）快速脱水。
电解质 / 酸碱失衡：高钾血症、代谢性酸中毒、高钙 / 高磷血症。
药物 / 毒物中毒：清除小分子毒物（巴比妥、甲醇、乙二醇等）。
其他：难治性高血压、高容量负荷、部分自身免疫病（辅助治疗）。
English
End-Stage Renal Disease (ESRD): Maintenance HD for ≥40kg patients.
Acute Kidney Injury (AKI): Oliguria/anuria, toxin buildup, electrolyte imbalance.
Severe Edema/Heart Failure: Isolated UF for rapid fluid removal.
Electrolyte/Acid-Base Disorders: Hyperkalemia, ｍmbedbolic acidosis, hypercalcemia.
Drug/Toxin Poisoning: Small molecule removal (barbiturates, methanol, ethylene glycol).
Other: Refractory hypertension, hypervolemia, autoimmune diseases (adjunct).
七、禁忌症（Contraindications）
中文
绝对禁忌
严重 ** 休克、低血压（SBP＜90mmHg）** 未纠正。
活动性大出血、DIC、严重凝血障碍。
颅内出血 / 脑水肿、严重精神异常无法配合。
晚期肿瘤、多器官衰竭、预期寿命＜3 个月（医患共识）。
患者 / 家属明确拒绝透析治疗。
相对禁忌（慎行 / 改良）
严重心律失常、心肌梗死急性期（≤7 天）。
严重贫血（Hb＜60g/L）（先输血再透析）。
高龄（＞80 岁）、婴幼儿（＜40kg）。
血管条件极差无法建立有效通路。
严重感染、败血症（控制后再透析）。
English
Absolute
Uncorrected shock, hypotension (SBP＜90mmHg).
Active bleeding, DIC, severe coagulopathy.
Intracranial hemorrhage, severe psychosis (uncooperative).
Terminal cancer, MOF, life expectancy＜3 months (consensus).
Patient/family refusal.
Relative (Caution/Modify)
Severe arrhythmia, acute MI (≤7d).
Severe anemia (Hb＜60g/L) (transfuse first).
Elderly (>80yo), infants (<40kg).
Poor vascular access.
Severe infection/sepsis (control before HD).
八、注意事项（Precautions）
中文
专业操作：持证血透医师 / 护士，严格 SOP、无菌操作。
术前自检：每次治疗前必须 T1 测试，不合格严禁使用。
参数核对：双人核对治疗模式、血流量、超滤量、温度、肝素。
通路安全：穿刺固定牢固，防脱出、出血、感染、血栓。
监测密集：治疗中每 15–30 分钟监测生命体征与压力，异常立即处理。
报警处置：不屏蔽报警；先停泵夹闭，再排查，严禁带故障运行。
脱水：严格按干体重设定超滤，防超滤过多（低血压 / 抽筋）/ 不足（水肿）。
感染防控：超纯透析、无菌操作、定期消毒、管路一次性使用。
维护合规：按周期校准、测试、消毒，保留完整记录。
应急准备：备生理盐水、肝素、鱼精蛋白、升压药、除颤仪，应对低血压 / 出血 / 心律失常。
English
Professional Use: Only licensed dialysis staff, strict SOP & asepsis.
Pre-Treatment Test: Mandatory T1 self-test; no treatment if failed.
Double-Check: Therapy mode, flows, UF, temp, heparin by two staff.
Access Safety: Secure cannulation; prevent dislodgement, bleeding, infection, thrombosis.
Close Monitoring: VS & pressures q15–30min; act fast on abnormality.
Alarm Response: Never bypass alarms; stop/clamp first; no fault operation.
Fluid Control: Strict dry-weight UF; avoid hypotension/cramps/fluid overload.
Infection Control: Ultrapure dialysate, asepsis, disinfection, single-use lines.
Compliant Maintenance: Calibrate/test/disinfect on schedule; full documentation.
Emergency Ready: Saline, heparin, protamine, vasopressors, defibrillator for crisis.
九、存储条件（Storage Conditions）
中文
环境：干燥、通风、避光、防尘、防腐蚀气体；温度15–30℃、湿度30–70%RH、无冷凝。
空间：距墙≥30cm、地面平整、防震动 / 挤压 / 摔落；远离热源、水源、电磁干扰。
耗材：A/B 液、透析器、管路原装密封、阴凉干燥，按有效期使用。
运输：温度 **-10℃～40℃**、防剧烈震动 / 雨淋；运输后静置 24 小时再开机。
长期停用：消毒、排空水路、断电、防尘罩覆盖；每月通电自检 1 次。
English
Environment: Dry, ventilated, light/dust/corrosion-proof; 15–30°C, 30–70%RH, non-condensing.
Space: ≥30cm from walls, level floor, shock/crush/drop-proof; away from heat/water/EMI.
Consumables: A/B solutions, dialyzers, lines sealed, cool/dry, use by expiry.
Shipping: -10°C～40°C, shock/rain protection; rest 24h before power-on.
Long-Term Storage: Full disinfection, drain water, power off, dust cover; monthly self-test.
十、说明书核心信息（Manual Key Inｆormation）
中文
产品标识：名称、型号 4008A、注册证号、批号、生产日期、厂家（费森尤斯）。
组成：血泵、肝素泵、双平衡腔、DIASAFEplus、监测模块（压力 / 气泡 / 漏血 / 电导 / 温度）、触屏、安全系统、水路 / 电路模块。
适用范围：≥40kg 慢性肾功能不全患者血液透析、单纯超滤。
操作流程：自检→安装→设置→预冲→治疗→监测→回血→消毒→维护。
安全规范：T1 测试、12 项监测、三级报警、自动保护、断电续航、合规校准。
报警清单：气泡、漏血、静脉高压 / 低压、动脉负压、跨膜压、电导、温度、平衡、液位、电源、肝素、自检故障。
维护周期：每日消毒、每周校准、每月测试、每年大修；记录存档≥5 年。
责任声明：专业医护使用；违规操作致不良事件，使用者担责；非原厂配件致损坏不在质保。
English
Labeling: Name, Model 4008A, Reg No., lot, MFG date, Fresenius Medical Care.
Components: Blood pump, heparin pump, dual balance chambers, DIASAFEplus, monitors (pressure/air/leak/conductivity/temp), touchscreen, safety, hydraulic/electrical modules.
Intended Use: HD & ISO-UF for ≥40kg chronic renal failure patients.
Workflow: Self-test → Install → Setup → Prime → Treat → Monitor → Return → Disinfect → Maintain.
Safety: T1 test, 12 monitors, 3-level alarms, auto-protection, battery backup, calibration.
Alarms: Air, blood leak, VEN high/low, ART low, TMP, conductivity, temp, balance, level, power, heparin, self-test fault.
Maintenance: Daily disinfect, weekly calibrate, monthly test, annual overhaul; records ≥5 years.
Liability: For professional use; user responsible for improper use; warranty void for non-original parts.
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 deveaf 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：厂家供应费森尤斯血液透析机4008A,费森尤斯血液透析机,血液透析机4008A
