厂家供应费森尤斯空心纤维血液透析器Hemoflow F4HPS
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厂家供应空心纤维血液透析器Hemoflow F4HPS
桂经理19117326863微xin同号
管理类别
第三类
型号规格
Hemoflow F4HPS, Hemoflow F5HPS, Hemoflow F6HPS, Hemoflow F7HPS, Hemoflow F8HPS, Hemoflow F10HPS
结构及组成/主要组成成分
本产品由以下部分组成：透析膜、外壳和顶盖、封装材料、密封环、血液保护帽和透析液保护帽。透析膜材料为聚砜纤维膜；外壳和顶盖材料为聚碳酸酯；封装材料为聚氨酯；密封环材料为硅树脂；血液保护帽和透析液保护帽材料为聚丙烯。本品灭菌方式为流动蒸汽灭菌。一次性使用。本品有效膜面积为0.8平方米-2.2平方米。
一、工作原理（Working Principle）
中文
基于 弥散、对流与超滤 三大核心原理，通过 聚砜空心纤维半透膜 实现血液净化：
弥散（Diffusion）：血液流经纤维管内，透析液在纤维管外逆向流动。由于 浓度梯度差，血液中的 小分子毒素（如尿素、肌酐、尿酸）通过膜上微孔 主动扩散 至透析液中被清除。
超滤（Ultrafiltration）：在 膜两侧压力差（TMP） 作用下，血液中 多余水分 被强制滤过 至透析液侧，实现脱水。
半透膜屏障：聚砜膜 具有的 孔径控制（约 3-5nm），允许 小分子毒素与水分 通过，但 阻止血细胞、白蛋白等大分子物质 流失，保证血液成分完整。
逆流高效交换：血液与透析液 逆向流动，最大化浓度梯度，提升毒素清除效率。
English
Based on diffusion, convection, and ultrafiltration, blood purification is achieved via Polysulfone hollow fiber semipermeable membrane:
Diffusion: Blood flows inside the hollow fibers; dialysate flows counter-currently outside. Driven by concentration gradient, small molecular toxins (urea, creatinine, uric acid) diffuse across membrane pores into dialysate for removal.
Ultrafiltration: Under transmembrane pressure (TMP), excess water is filtered from blood to dialysate for fluid removal.
Semipermeable Barrier: Polysulfone membrane with precise pore size control (3–5nm) allows passage of small solutes/water but retains blood cells, albumin, preserving blood integrity.
Counter-Current Flow: Maximizes concentration gradient for optimal solute clearance efficiency.
二、核心功能（Core Functions）
中文
小分子毒素高效清除
清除 尿毒症小分子毒素：尿素、肌酐、尿酸、胍类、酚类等。
实现 充分透析，维持电解质（钾、钠、氯、钙）与酸碱平衡。
容量超滤
稳定、可控 清除体内多余水分，治疗 水肿、心衰、容量负荷过重。
超滤系数（Kuf） 稳定，配合透析机实现 容量控制。
血液安全保护
生物相容性：抑制凝血、减少补体激活、降低过敏反应。
内毒素截留：低通量膜 有效阻止透析液中 内毒素反渗，预防致热反应。
临床适配广泛
6 种膜面积规格（0.8~2.2㎡），适配 儿童、成人、不同体重 患者。
标准低通量，适配 所有品牌血液透析机，用于 常规 HD 治疗。
English
High-Efficiency Small Solute Clearance
Removes uremic small molecules: urea, creatinine, uric acid, guanidines, phenols.
Achieves adequate dialysis, maintains electrolyte (K⁺, Na⁺, Ca²⁺) & acid-base balance.
Precise Fluid Ultrafiltration
Stable, controlled fluid removal for edema, heart failure, volume overload.
Stable ultrafiltration coefficient (Kuf) enables precision volume control with dialysis machines.
Blood Safety & Protection
Excellent biocompatibility: minimizes clotting, complement activation, hypersensitivity.
Endotoxin Retention: Low-flux membrane blocks endotoxin backfiltration, preventing pyrogenic reactions.
Broad Clinical Compatibility
6 surface area options (0.8–2.2㎡) for pediatric, adult, all body weights.
Standard low-flux, compatible with all hemodialysis machines for routine HD.
三、产品特点（Product Features）
中文
经典聚砜膜（Gold Standard）
医用级聚砜（Polysulfone） 材质，30 年临床验证，生物相容性准。
不对称双层膜结构：致密内层 保证筛分，疏松外层 提供高通透性与支撑。
亲水性优化：膜表面亲水，减少蛋白吸附、抑制凝血、降低溶血风险。
低通量设计（HPS 系列）
严格低通量：Kuf 5.5~7.0 mL/hr/mmHg，超滤可控、安全、稳定，无反渗风险。
小分子高清除：尿素（KoA）、肌酐清除率 ，透析充分性（Kt/V）达标率高。
β2 - 微球蛋白截留：有效保留 白蛋白与部分中分子蛋白，减少营养丢失。
波浪纤维结构（Undulating Fiber）
空心纤维呈波浪形，纤维间距均匀，杜绝透析液沟流（Channeling）。
每根纤维充分利用，交换面积最大化、效率提升、阻力降低。
安全设计
蒸汽灭菌（Steam Sterilized）：无环氧乙烷残留，热原更低、过敏风险更小。
无乳胶、无 PVC：材质安全，避免乳胶过敏。
外壳耐压：聚碳酸酯（Polycarbonate） 外壳，耐高压、抗破裂、透明可视。
严格质量检测：100% 压力测试、漏血测试、完整性检测，零缺陷出厂。
规格齐全、选择
F4HPS(0.8㎡)~F10HPS(2.2㎡) 6 种规格，按体重 / 血流量选择。
预充容量低（63~115mL），体外循环血量小，血流动力学更稳定。
一次性使用
独立无菌包装，一次性使用，杜绝复用感染、交叉污染、膜性能衰减。
English
Classic Polysulfone Membrane (Gold Standard)
Medical-grade Polysulfone, 30+ years clinical proof, biocompatibility benchmark.
Asymmetric dual-ｌayer: dense inner ｌayer for precise sieving; porous outer ｌayer for permeability & support.
Hydrophilic: minimizes protein adsorption, clotting, hemolysis.
Low-Flux Precision (HPS Series)
Strict low-flux: Kuf 5.5–7.0 mL/hr/mmHg, safe, stable, controlled UF, no backfiltration risk.
Superior small solute clearance: leading urea (KoA)/creatinine clearance, high Kt/V adequacy.
β₂-microglobulin retention: preserves albumin/nutrients, reduces protein loss.
Undulating Hollow Fiber Design
Wavy fibers ensure uniｆorm spacing, eliminates dialysate channeling.
Full fiber utilization, max efficiency, minimal resistance.
Comprehensive Safety
Steam Sterilized: no ETO residue, lower pyrogen/hypersensitivity risk.
Latex/PVC-free: safe materials, no latex allergy.
Polycarbonate housing: high pressure-resistant, shatterproof, clear visualization.
100% testing: pressure, blood leak, integrity—zero defect release.
Complete Size Range
6 sizes (F4HPS 0.8㎡ ~ F10HPS 2.2㎡) for precise weight/flow matching.
Low priming volume (63–115mL), minimal extracorporeal volume, stable hemodynamics.
Single-Use Only
Individually sterile packed, single-use, eliminates reuse infection/cross-contamination.
四、技术参数（Technical Specifications）
表格
参数（中） Parameter (En) F4HPS F5HPS F6HPS F7HPS F8HPS F10HPS
型号 Model F4HPS F5HPS F6HPS F7HPS F8HPS F10HPS
有效膜面积 Effective Surface Area 0.8 ㎡ 1.0 ㎡ 1.3 ㎡ 1.6 ㎡ 1.8 ㎡ 2.2 ㎡
超滤系数 (Kuf) Ultrafiltration Coefficient 5.5 6.0 6.5 6.5 7.0 7.0 (mL/hr/mmHg)
预充容量 Priming Volume 63 mL 73 mL 85 mL 95 mL 105 mL 115 mL
纤维内径 / 外径 Fiber ID/OD 200 / 215 µm 200 / 215 µm 200 / 215 µm 200 / 215 µm 200 / 215 µm 200 / 215 µm
尿素清除率 (KoA) Urea Clearance (KoA) 780 850 930 1020 1080 1180 (mL/min)
肌酐清除率 Creatinine Clearance 670 730 800 870 920 1000 (mL/min)
维生素 B12 清除率 B12 Clearance <50 <55 <60 <65 <70 <75 (mL/min)
最大血流量 Max Blood Flow 300 350 400 500 500 600 (mL/min)
透析液流量 Dialysate Flow 500–800 mL/min 500–800 mL/min 500–800 mL/min 500–800 mL/min 500–800 mL/min 500–800 mL/min
膜材质 Membrane Material 聚砜 (Polysulfone) 聚砜 (Polysulfone) 聚砜 (Polysulfone) 聚砜 (Polysulfone) 聚砜 (Polysulfone) 聚砜 (Polysulfone)
外壳材质 Housing 聚碳酸酯 (PC) 聚碳酸酯 (PC) 聚碳酸酯 (PC) 聚碳酸酯 (PC) 聚碳酸酯 (PC) 聚碳酸酯 (PC)
灭菌方式 Sterilization 蒸汽灭菌 (Steam) 蒸汽灭菌 (Steam) 蒸汽灭菌 (Steam) 蒸汽灭菌 (Steam) 蒸汽灭菌 (Steam) 蒸汽灭菌 (Steam)
使用类型 Usage 一次性 (Single-use) 一次性 (Single-use) 一次性 (Single-use) 一次性 (Single-use) 一次性 (Single-use) 一次性 (Single-use)
管理类别 Classification Ⅲ 类 Ⅲ 类 Ⅲ 类 Ⅲ 类 Ⅲ 类 Ⅲ 类
五、使用方法（Usage Instructions）
中文
1. 术前检查
核对：型号、规格、有效期、包装完好、无破损、无菌。
外观：外壳透明无裂纹、纤维无变色、无凝血、无气泡。
2. 安装与预冲
安装：将透析器 固定于透析机支架，动脉端（红色）朝上，静脉端（蓝色）朝下。
连接管路：动脉血路接透析器上端（Blood In），静脉血路接下端（Blood Out）。
预冲：
生理盐水预冲：血流量 100~150mL/min，透析液流量 500mL/min，排气、湿润膜、去除保护液、微粒。
预冲量：≥500mL，确认无气泡、无漏血、透析液清澈。
闭路循环：3~5 分钟，检查凝血、膜完整性。
3. 治疗连接
无菌操作：消毒患者血管通路。
引血：缓慢启动血泵（50~100mL/min），观察透析器颜色、无凝血、无气泡。
上机：调至目标血流量，启动透析液、超滤、肝素泵。
4. 治疗监测
全程观察：透析器颜色（无凝血变黑）、静脉压、跨膜压（TMP）、漏血、气泡。
参数控制：TMP < 300mmHg，避免超压破膜。
报警处理：漏血、压力异常、气泡 → 立即停机、排查、处理。
5. 治疗结束
回血：生理盐水回血，回收血液。
分离：停机、分离管路。
处置：一次性医疗废物 规范销毁，严禁复用。
English
1. Pre-Treatment Inspection
Verify: model, size, expiry, intact sterile package.
Visual: no cracks, discoloration, clots, air.
2. Installation & Priming
Mount: Secure dialyzer on holder with arterial (red) up, venous (blue) down.
Connect Lines: Arterial line → Blood In (top)；Venous line → Blood Out (bottom).
Prime:
Saline prime: 100–150mL/min blood flow, 500mL/min dialysate to de-air, wet membrane, remove preservative/particles.
Prime volume ≥500mL; confirm no air/blood leak, clear dialysate.
Recirculate 3–5min to check clotting/integrity.
3. Treatment Connection
Aseptic Technique: disinfect vascular access.
Initiate Flow: start low flow (50–100mL/min), monitor color, clotting, air.
Therapy Start: Ramp to target blood flow; start dialysate, ultrafiltration, heparin.
4. Therapy Monitoring
Continuous Observation: fiber color (no darkening), venous pressure, TMP, blood leak, air.
Pressure Control: TMP < 300mmHg to prevent membrane rupture.
Alarms: Blood leak, pressure, air → immediate stop, troubleshoot.
5. Termination
Blood Return: Saline rinse to recover all blood.
Disconnect: Stop machine, disconnect lines.
Disposal: Discard as medical waste—DO NOT REUSE.
六、适应症（Indications）
中文
终末期肾病（ESRD）：慢性肾功能衰竭 维持性 常规血液透析（HD）。
急性肾损伤（AKI）：急性肾功能衰竭 需紧急 血液透析 治疗。
药物 / 毒物中毒：可通过 低通量透析 清除的 小分子药物、毒物 中毒。
电解质紊乱：严重高钾血症、高钠血症、代谢性酸中毒。
容量超负荷：急性肺水肿、难治性心衰、严重水肿（需单纯超滤）。
适用人群：成人、青少年、儿童（选小面积型号）。
English
End-Stage Renal Disease (ESRD): Chronic renal failure for maintenance routine hemodialysis (HD).
Acute Kidney Injury (AKI): Acute renal failure for emergency hemodialysis.
Drug/Poison Intoxication: Small-molecule agents removable by low-flux dialysis.
Electrolyte Imbalance: Severe hyperkalemia, hypernatremia, ｍmbedbolic acidosis.
Volume Overload: Acute pulmonary edema, refractory heart failure, severe edema (isolated UF).
Population: Adults, adolescents, children (smaller sizes).
七、禁忌症（Contraindications）
中文
绝对禁忌
对聚砜膜、聚氨酯、聚碳酸酯等组件材质 过敏者。
无法建立有效血管通路 者。
患者拒绝血液透析 治疗。
相对禁忌（慎用）
严重凝血功能障碍、活动性大出血（高出血风险）。
严重休克、顽固性低血压（SBP < 90mmHg，无法耐受）。
严重贫血（Hb < 60g/L，需先纠正）。
精神障碍、认知缺陷、无法配合 治疗。
晚期恶性肿瘤、恶病质、预期生存期 < 30 天。
English
Absolute Contraindications
Hypersensitivity to Polysulfone, Polyurethane, Polycarbonate, or components.
No viable vascular access.
Patient refusal of hemodialysis.
Relative Contraindications (Caution)
Severe coagulopathy/active bleeding (high hemorrhage risk).
Severe shock/refractory hypotension (SBP < 90mmHg, intolerant).
Severe anemia (Hb < 60g/L, correct first).
Psychosis/cognitive impairment/non-cooperation.
Terminal malignancy/cachexia, life expectancy < 30 days.
八、注意事项（Precautions）
中文
资质与无菌
持证医护人员 操作，严格无菌技术。
一次性使用，包装破损、过期、潮湿严禁使用。
型号选择
按患者体重、血流量、透析剂量 选择：F4~F6（小 / 体重低）、F7~F8（标准成人）、F10（大体重 / 高流量）。
严禁超最大血流量 使用，防止破膜、溶血。
预冲规范
必须充分预冲排气，严禁带气泡上机（空气栓塞风险）。
预冲液观察：清澈、无微粒、无变色。
治疗监测
全程监测：TMP、静脉压、动脉压、漏血、颜色、患者生命体征。
凝血预警：透析器变黑、纤维条纹状凝血、压力升高 → 立即追加肝素或更换。
漏血：透析液变色、漏血报警 → 立即停机、更换透析器。
安全压力
TMP ≤ 300mmHg，严禁超压（破膜、失血风险）。
避免管路扭曲、受压、流量不足。
过敏处理
过敏反应（皮疹、瘙痒、寒战、发热、呼吸困难）→ 立即停机、回血、抗过敏治疗。
复用禁止
严禁清洗、消毒、重复使用（感染、膜破裂、毒素清除下降、内毒素污染 致命风险）。
废物处理
按感染性医疗废物 规范销毁。
English
Qualification & Asepsis
Licensed staff only, strict aseptic technique.
Single-use—do not use if damaged/expired/wet.
Size Selection
Match to weight, blood flow, dose: F4–F6 (small/low weight), F7–F8 (standard adult), F10 (large/high flow).
Do not exceed max blood flow (risk rupture/hemolysis).
Priming Protocol
Thorough priming/de-airing—no air bubbles (air embolism risk).
Prime effluent must be clear, no particles/discoloration.
Therapy Monitoring
Continuous monitoring: TMP, venous/arterial pressure, blood leak, color, vital signs.
Clotting Alert: darkening, streaking, rising pressure → heparin or replace.
Blood Leak: discolored dialysate/alert → immediate stop/replace.
Pressure Safety
TMP ≤ 300mmHg—no overpressure (rupture/hemorrhage).
Avoid kinking, compression, low flow.
Hypersensitivity
Reaction (rash, chills, fever, dyspnea) → stop, return blood, treat.
No Reuse
DO NOT clean, sterilize, reuse (fatal infection, rupture, reduced clearance, endotoxin).
Waste Disposal
Discard as infectious medical waste.
九、存储条件（Storage Conditions）
中文
温度：5℃ ~ 30℃
湿度：20% ~ 80% RH，无冷凝
环境：干燥、通风、清洁、避光、无尘、无腐蚀性气体
禁止：高温、冷冻、阳光直射、潮湿、X 光照射、化学污染、挤压、穿刺、跌落
包装与有效期：独立无菌纸塑包装；有效期 3 年（蒸汽灭菌、存储合规）
使用前检查：包装完好、灭菌指示合格、在有效期内、无破损
English
Temperature: 5°C – 30°C
Humidity: 20–80% RH, non-condensing
Environment: Dry, ventilated, clean, dark, dust-free, non-corrosive
Prohibited: Heat, freezing, sunlight, moisture, X-ray, chemicals, crushing, puncture, dropping
Packaging & Shelf Life: Individual sterile blister pack; 3 years (steam sterilized, proper storage)
Pre-Use Check: Intact package, sterility indicator valid, within expiry, no damage
十、说明书核心信息（Manual Key Inｆormation）
中文
产品信息
名称：空心纤维血液透析器
型号：Hemoflow F4HPS~F10HPS
注册证：国械注进 20163104863
生产：Fresenius Medical Care, Germany
材质：聚砜膜、聚碳酸酯外壳、聚氨酯封装
灭菌：蒸汽灭菌，一次性使用
类别：Ⅲ 类医疗器械
预期用途
用于 急性或慢性肾功能衰竭、药物中毒、电解质紊乱、容量超负荷 患者的 常规血液透析（HD）治疗。
核心安全警告
致命过敏：材质过敏者禁用，使用中出现 过敏反应立即停机。
破膜致命：严禁超压（TMP>300mmHg），超压致膜破裂、大出血、死亡。
复用致命：一次性使用，严禁复用，复用致 败血症、内毒素休克、死亡。
空气栓塞：必须预冲排气，带气泡上机致空气栓塞、死亡。
无监测禁用：必须连接漏血、压力、气泡监测，无监测严禁使用。
并发症警示
感染：菌血症、败血症（无菌不当、复用）。
出血：破膜、穿刺、抗凝过度。
凝血：透析器凝血、管路堵塞、失血。
过敏：皮疹、寒战、发热、呼吸困难、休克。
空气栓塞：胸痛、呼吸困难、猝死。
责任声明
未按说明书 操作、复用、超压、超期、无菌不当 致 患者伤害 / 死亡，由 使用者 / 医疗机构 承担全部责任。
English
Product Identification
Name: Hollow Fiber Hemodialyzer
Model: Hemoflow F4HPS~F10HPS
Reg. No.: 国械注进 20163104863
Manufacturer: Fresenius Medical Care, Germany
Materials: Polysulfone membrane, Polycarbonate housing, Polyurethane potting
Sterilization: Steam sterilized, single-use
Class: Class III Medical Device
Intended Use
For routine hemodialysis (HD) in patients with acute/chronic renal failure, drug intoxication, electrolyte imbalance, volume overload.
Critical Safety Warnings
Fatal Hypersensitivity: Contraindicated in material allergy; stop immediately if reaction occurs.
Fatal Rupture: Do not exceed TMP>300mmHg—rupture causes massive hemorrhage/death.
Fatal Reuse: Single-use only—NO REUSE; reuse causes sepsis, endotoxin shock, death.
Air Embolism: Full priming/de-airing mandatory; air causes embolism/death.
No Monitoring = No Use: Blood leak, pressure, air monitoring required.
Complication Alerts
Infection: Bacteremia/sepsis (poor asepsis/reuse).
Hemorrhage: Rupture, puncture, over-anticoagulation.
Clotting: Dialyzer clotting, line occlusion, blood loss.
Hypersensitivity: Rash, chills, fever, dyspnea, shock.
Air Embolism: Chest pain, dyspnea, sudden death.
Liability: User/institution liable for injury/death from improper use, reuse, overpressure, expired, poor asepsis.
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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