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上海康世达医疗器械有限公司 主营产品:医用体检,诊断,急救,化验,超声,医学分析,生命科学,消毒灭菌,康复治疗,手术室,急救室,诊疗室等设备,一类医疗器械,二类医疗器械,三类医疗器械,IVD及消毒器具耗材

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厂商供应费森尤斯血液净化体外循环血路6008 CAREset-R

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品牌名称:$brandModel.Title型号: 原产地:中国大陆 医疗器械注册号(批文): 国械注进20233100280更新时间:2026/10/16 11:04:36

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血液回收设备及耗材

血液透析设备及耗材

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厂商供应费森尤斯血液净化体外循环血路6008 CAREset-R

桂经理19117326863微xin同号

管理类别

第三类

型号规格

6008 CAREset-R,6008 CAREset L-R,6008 CAREset BVM-R,6008 CAREset BVM L-R

结构及组成/主要组成成分

产品由泵管,PVC管,透析接头,患者接头,动脉采样口,静脉采样口,盒式管路(包括一体式盒体,接头,背膜,血块过滤器,单向阀,疏水膜),肝素管路,鲁尔接头,预冲接头,管路夹,保护帽组成。6008 CAREset BVM-R和CAREset BVM L-R含BVM液体槽。产品主要材质为聚氯乙烯(PVC)。本产品采用电子束灭菌,一次性使用。

适用范围/预期用途

该产品与血液透析设备配合使用,用于体外血液透析、血液滤过、血液透析滤过及单纯超滤治疗。


一、工作原理(Working Principle)

中文

体外循环建立

经动脉端引出血液,经蠕动泵驱动流经透析器 / 血滤器,完成弥散、对流、超滤净化后,由静脉端回输体内;全程无菌密闭,避免空气与污染进入。

盒式集成过滤

静脉侧一体式盒体含血块过滤器(截留微栓 / 血栓)、单向阀(防反流)、疏水膜(排气 / 防气栓),与管路一体化集成,减少连接点与漏血风险。

抗凝与监测

预留肝素管路与鲁尔锁接口,按需持续输注抗凝;多采样口支持动脉 / 静脉血气、电解质与压力监测,实时评估循环与净化效果。

English

Extracorporeal Circulation

Drains blood from the patient via the arterial line, drives it through the dialyzer/hemofilter by peristaltic pump, and returns purified blood via the venous line. A sealed, sterile circuit prevents air entry and contamination.

Integrated Cassette Filtering

The in-line cassette houses a clot filter (traps microemboli/thrombi), check valve (prevents reflux), and hydrophobic membrane (deaeration/air embolism protection). Integrated design minimizes connections and leakage risks.

Anticoagulation & Monitoring

Dedicated heparin line and Luer-lock ports enable targeted anticoagulation delivery. Multiple sampling ports allow real-time blood gas, electrolyte, and pressure monitoring for circulation and purification efficacy.

二、核心功能(Core Functions)

表格

中文功能 English Function

多模式适配:支持 HD、HF、HDF、单纯超滤,与 6008 CAREsystem 无缝匹配 Multi-Mode: HD, HF, HDF, UF; compatible with 6008 CAREsystem

安全过滤:盒式血块过滤器 + 疏水膜,防微栓、防空气栓塞 Safety Filtration: Clot filter + hydrophobic membrane; microemboli/air embolism protection

抗凝:专用肝素管路,可控输注枸橼酸 / 肝素 Targeted Anticoagulation: Dedicated heparin line; controlled citrate/heparin delivery

多维度监测:动 / 静脉压力、流量、血气、电解质实时采样 Comprehensive Monitoring: Arterial/venous pressure, flow, blood gas, electrolyte sampling

低预充低阻力:优化管路设计,减少血液稀释与血细胞损伤 Low Prime & Low Resistance: Minimizes hemodilution and blood cell damage

防反流防漏血:单向阀 + 鲁尔锁 + 密封接头,保障回路安全 Anti-Reflux & Leak-Proof: Check valve + Luer-lock + sealed connectors

三、产品特点(Product Features)

中文

一体化集成设计

动脉 / 静脉管路、盒式过滤模块、肝素管路、采样口、预冲接头全预装,即插即用,减少操作步骤与感染风险。

高生物相容性材质

主体为医用 PVC,内壁光滑、低吸附,降低血栓与炎症反应;无 DEHP、无乳胶、无热原,提升患者耐受性。

临床安全优化

盒式集成:集过滤、止回、排气于一体,减少连接点,降低漏血 / 进气概率;

多采样端口:动脉 / 静脉预留采样口,便捷采血监测,减少穿刺损伤;

管路夹 + 保护帽:便捷阻断与密封,防止操作污染。

高效适配性

专为 6008 CAREsystem 设计,预连接匹配泵头、传感器与透析器,实现一键预冲、自动化反馈控制,提升医护效率。

一次性无菌供应

采用电子束灭菌,无菌包装,一次性使用,避免交叉感染;注册证号:国械注进 20233100280。

English

All-in-One Integrated Design

Pre-assembled arterial/venous lines, in-line cassette, heparin line, sampling ports, and priming connectors. Plug-and-play setup reduces procedural steps and infection risks.

High Biocompatibility

Medical PVC construction; smooth inner surface minimizes thrombosis and inflammation. DEHP-free, latex-free, non-pyrogenic for improved patient tolerance.

Clinical Safety Enhancements

Integrated Cassette: Combines filtration, check valve, and deaeration to reduce connection points and leakage/air entry risks;

Multiple Sampling Ports: Arterial/venous ports for convenient blood sampling and monitoring, reducing puncture trauma;

Clamps & Protective Caps: Easy line occlusion and sealing to prevent contamination during handling.

System Compatibility

Custom-designed for 6008 CAREsystem; pre-connected to pump, sensors, and dialyzer for one-touch priming and automated feedback control, enhancing clinical efficiency.

Single-Use Sterility

Electron beam-sterilized, sterile package; single-use only to prevent cross-contamination. Registration No.: 国械注进 20233100280.


四、技术参数(Technical Specifications)

表格

参数(中) Parameter (En) 规格

型号 Model 6008 CAREset-R

产品类型 Type 血液净化体外循环血路(一次性)

主要材质 Main Material 医用 PVC(无 DEHP、无乳胶)

核心结构 Core Structure 动脉管路、静脉管路、盒式模块(血块过滤器 / 单向阀 / 疏水膜)、肝素管路、采样口、鲁尔锁、管路夹

预充容量 Priming Volume 约 280–320mL(适配 6008 系统)

血流范围 Blood Flow Range 200–500 mL/min(常规);最高可达 600 mL/min

压力监测 Pressure Monitoring 动脉压 / 静脉压 / 跨膜压(TMP),兼容 6008 系统传感器

过滤能力 Filtration Capacity 血块过滤器截留≥10µm 微栓;疏水膜排气效率≥99%

灭菌方式 Sterilization 电子束灭菌

包装规格 Package 1 套 / 无菌袋;一次性使用

注册证号 Registration No. 国械注进 20233100280

生产厂家 Manufacturer 费森尤斯医药用品股份及两合公司(土耳其)

代理人 Agent 费森尤斯医药用品(上海)有限公司

五、使用方法(Usage Instructions)

中文

1. 治疗前准备

核对型号、有效期、包装完好、无菌,检查管路无扭曲、打折、破损;

准备 6008 CAREsystem 主机、透析器 / 血滤器、预充液(生理盐水)、抗凝剂(肝素 / 枸橼酸)、穿刺针 / 中心静脉导管;

开机完成主机自检,按系统提示连接血路与透析器,确认血流方向正确。

2. 密闭式预冲

启动血泵(80–100 mL/min),用生理盐水预冲动脉端→透析器→静脉端,排尽空气;

泵速调至 200–300 mL/min,连接透析液旁路,排净透析器膜外气体;

按需用肝素生理盐水预冲(遵医嘱),预冲量符合透析器说明书要求;

预冲完毕,设置治疗参数(血流量、超滤率、透析液浓度等)。

3. 患者连接与上机

无菌操作建立血管通路(动静脉瘘穿刺或中心静脉导管);

连接动脉 / 静脉血路至患者通路,蝶形固定穿刺针或妥善固定导管,防止脱落;

启动低流量(100–150 mL/min),观察漏血、气泡、压力变化,确认回路安全;

逐步调至目标血流量(200–500 mL/min),启动抗凝输注,监测 ACT/APTT 维持在治疗范围。

4. 治疗中监测

每小时监测动脉压、静脉压、TMP、流量、超滤量、体温、血气,观察患者生命体征与不适症状;

固定管路,防止扭结、受压、脱落;翻身 / 移动时避免牵拉血路;

若出现高压报警、漏血、气泡进入,立即停泵处理,必要时更换血路。

5. 回血与下机

治疗结束,调整血流量至 50–100 mL/min,启动密闭式回血;

动脉端预冲侧管输注生理盐水回输动脉侧血液,再靠重力或血泵回输静脉侧血液,直至血路排空;

拔除穿刺针 / 分离导管,按压止血,完成下机;

血路一次性废弃,按感染性医疗废物处理;清洁消毒主机与治疗区域。

English

1. Pre-Treatment Preparation

Verify model, expiry, package integrity, and sterility; inspect lines for kinks, damage, or torsion;

Prepare 6008 CAREsystem console, dialyzer/hemofilter, prime solution (saline), anticoagulant (heparin/citrate), and cannulae/central venous catheter;

Power on the console and complete self-test; connect the circuit to the dialyzer per system instructions, confirming correct blood flow direction.

2. Closed Priming

Start blood pump at 80–100 mL/min; prime arterial line → dialyzer → venous line with saline to fully remove air;

Adjust pump speed to 200–300 mL/min; connect to dialyzer bypass to purge air from the dialyzer membrane side;

Prime with heparinized saline (per physician order) after saline priming, following dialyzer instructions;

Set treatment parameters (blood flow, UF rate, dialysate concentration) after priming.

3. Patient Connection & Initiation

Establish vascular access (AVF puncture or central venous catheter) under aseptic technique;

Connect arterial/venous lines to the patient; secure puncture needles with butterfly dressing or fix catheter properly to prevent dislodgement;

Start low flow (100–150 mL/min); check for leaks, air entry, and pressure stability;

Gradually increase to target flow (200–500 mL/min); initiate anticoagulation; monitor ACT/APTT to maintain therapeutic range.

4. Intra-Treatment Monitoring

Check arterial/venous pressure, TMP, flow, UF volume, temperature, and blood gas hourly; assess patient vital signs and symptoms;

Secure lines to prevent kinking, pressure, or dislodgement; avoid pulling during repositioning;

For high-pressure alarms, leaks, or air embolism, stop the pump immediately; replace the circuit if necessary.

5. Blood Return & Termination

At treatment end, reduce flow to 50–100 mL/min; initiate closed blood return;

Infuse saline via the arterial priming port to return arterial side blood, then gravity/pump return venous side blood until the circuit is empty;

Remove puncture needles/disconnect catheter; apply pressure to stop bleeding;

Dispose of the circuit as infectious waste; clean and disinfect the console and treatment area.

六、适应症(Indications)

中文

与 6008 CAREsystem 配套,用于成人及儿童的以下血液净化治疗:

慢性肾衰竭(CRF):维持性血液透析(HD)、血液透析滤过(HDF);

急性肾损伤(AKI):伴多器官衰竭、脓毒症、创伤、术后肾功能衰竭,需 HF/HDF/ 单纯超滤;

其他:难治性容量负荷过重、电解质紊乱、药物 / 毒物中毒(联合灌流)。

English

Indicated for adults and children undergoing blood purification with 6008 CAREsystem:

Chronic Renal Failure (CRF): Maintenance hemodialysis (HD), hemodiafiltration (HDF);

Acute Kidney Injury (AKI): With MOF, sepsis, trauma, or post-operative renal failure; requires HF/HDF/ultrafiltration;

Others: Refractory volume overload, electrolyte disorders, drug/toxin intoxication (combined with hemoperfusion).

七、禁忌症(Contraindications)

中文

绝对禁忌

对PVC、肝素、枸橼酸等材质严重过敏者;

无法建立有效血管通路(如严重血管钙化、闭塞);

严重凝血功能障碍且无法抗凝(如活动性大出血、DIC 终末期);

患者 / 家属明确拒绝体外循环治疗。

相对禁忌(慎用)

严重出血风险(如颅内出血未控制、消化道大出血);

严重肝功能衰竭伴枸橼酸代谢障碍(慎用枸橼酸抗凝);

严重低血压(收缩压<70 mmHg)且无法纠正;

儿童体重<10 kg(需选用专用儿科血路)。

English

Absolute Contraindications

Severe allergy to PVC, heparin, or citrate;

Inadequate vascular access (e.g., severe vascular calcification/occlusion);

Severe coagulopathy with uncontrollable bleeding (e.g., active hemorrhage, end-stage DIC);

Patient/family refusal of extracorporeal circulation treatment.

Relative Contraindications (Caution)

High bleeding risk (e.g., uncontrolled intracranial hemorrhage, severe GI bleeding);

Severe liver failure with citrate mmbedbolism impairment (use citrate anticoagulation with caution);

Severe hypotension (SBP < 70 mmHg) uncorrectable by intervention;

Children < 10 kg (pediatric-specific circuit required).

八、注意事项(Precautions)

中文

专业操作:血液净化专业医护操作,严格遵循无菌 SOP 与说明书流程;

术前核查:包装破损、过期、污染严禁使用;管路扭曲、打折、漏气 / 漏血禁止上机;

耗材匹配:与 6008 CAREsystem 配套使用,禁止与其他品牌透析机混用;

抗凝管理:根据患者凝血功能个体化调整肝素 / 枸橼酸剂量,监测 ACT/APTT/ 血钙,防出血 / 血栓;

安全防护:全程监测空气进入,预冲必须;管路固定牢固,防止脱落导致空气栓塞或大出血;

时限控制:血路一次性使用,开封后 4 小时内未使用需废弃;连续使用不超过 24 小时(遵医嘱);

并发症处理:

高压报警:排查管路打折、滤网堵塞,必要时更换血路;

漏血 / 进气:立即





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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