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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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厂商直销日机装血液净化设备Aquarius(GE-F095-00-CN)

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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):国械注准20263100649更新时间:2026/10/19 9:40:51

产品摘要:厂商直销日机装血液净化设备Aquarius(GE-F095-00-CN)

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导管 管路

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反搏设备

注射泵 输液泵

高频电刀

起搏器

听力设备

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检测仪 测量仪

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耗材

排痰机

超声

止血设备

医学检验设备

床

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血压计

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呼吸/麻醉设备

设备

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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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详细内容

厂商直销日机装血液净化设备Aquarius(GE-F095-00-CN)
桂经理19117326863微xin同号

管理类别

第三类

型号规格

Aquarius(GE-F095-00-CN)

结构及组成/主要组成成分

由显示屏、压力感应器、血液泵、滤液泵、前/后置换液泵、除气壶(温度感应器)、肝素泵、空气探测器、血液渗漏探测器、枸橼酸泵、钙泵、枸橼酸功能模块(选配)、静脉输液架、平衡称、静脉夹、轮座组成。

适用范围/预期用途

该产品在体外血液净化治疗过程中提供动力及安全监测,与兼容的一次性使用耗材联合使用,临床适用于体重在20Kg以上的患者连续性肾脏替代治疗、血浆置换治疗及血液灌流治疗。

一、工作原理 / Working Principle

中文Aquarius(GE-F095-00-CN)为连续性床旁血液净化设备,通过体外循环 + 半透膜技术,联合弥散、对流、吸附原理清除溶质与水分:

  1. 血泵驱动:血液经血管通路引出,流经滤器 / 血浆分离器。

  2. 弥散(透析):小分子毒素(尿素、肌酐)顺浓度梯度跨膜交换。

  3. 对流(滤过):跨膜压(TMP)驱动水分与中大分子溶质被滤出。

  4. 吸附:配合灌流器 / 特殊滤器吸附炎症因子、胆红素、免疫复合物。

  5. 液体平衡:精密天平与多泵控制置换 / 透析液输注、超滤脱水,精度<1%。

  6. 安全监测:压力、气泡、漏血、温度、电导实时监控,异常自动联锁保护。

EnglishAquarius (GE-F095-00-CN) is abedside continuous blood purification systemthat removes solutes and fluid viaextracorporeal circulation + semipermeable membraneusingdiffusion, convection, adsorption:

  1. Blood pump: Draws blood from vascular access through filter/plasma separator.

  2. Diffusion (dialysis): Small solutes (urea, creatinine) cross membrane down concentration gradient.

  3. Convection (filtration): Fluid and middle/large molecules removed under TMP.

  4. Adsorption: Removes cytokines, bilirubin, immune complexes via adsorbers.

  5. Fluid balance: Precision scales & multi-pump control for replacement/dialysate infusion & ultrafiltration (accuracy <1%).

  6. Safety monitoring: Real-time pressure, air, blood leak, temp, conductivity; auto interlocks on fault.


二、产品功能 / Functions

中文

  • 全模式治疗:SCUF、CVVH、CVVHD、CVVHDF、TPE(血浆置换)、HP(血液灌流)

  • 枸橼酸抗凝:专用枸橼酸 / 钙泵,成人 CRRT 枸橼酸抗凝

  • 液体管理:0–10000ml/h 置换 / 透析液、0–12000ml/h 滤过、容量平衡

  • 多泵系统:血泵、滤过泵、前 / 后置换泵、肝素泵、枸橼酸泵、钙泵

  • 安全监测:4 路压力、超声气泡(1µl 灵敏)、漏血、温度、电导、管路在位

  • 自动化:自动预冲、自检、报警、数据记录、加热(35–39℃)

  • 界面:彩色触屏、中文界面、治疗曲线、历史日志、远程接口

English

  • Full therapy modes: SCUF, CVVH, CVVHD, CVVHDF, TPE, HP

  • Citrate anticoagulation: Dedicated citrate/calcium pumps (adult only)

  • Fluid management: 0–10000ml/h replacement/dialysate, 0–12000ml/h effluent, precision balance

  • Multi-pump: Blood, effluent, pre/post-replacement, heparin, citrate, calcium pumps

  • Safety monitors: 4 pressures, ultrasonic air (1µl), blood leak, temp, conductivity, line presence

  • Automation: Auto-prime, self-test, alarms, data logging, heating (35–39°C)

  • Interface: Color touchscreen, Chinese UI, trends, logs, remote access





三、产品特点 / Features

中文

  1. 床旁全能:20kg 以上成人 / 儿童,CRRT + 血浆置换 + 灌流三机一体

  2. 枸橼酸专属:双泵调控,降低出血风险,适合高危患者

  3. 精度极高:天平式称重,平衡误差<1%,长时间稳定

  4. 安全:八重监测、无源安全夹、断电自锁、声光报警

  5. 操作简便:一键预冲、中文导航、模块化管路、快速安装

  6. 灵活配置:前 / 后稀释、序贯治疗、可调血流 10–450ml/min

  7. 合规可靠:国械注进 20203100418,符合 ISO、YY 标准

English

  1. All-in-one bedside: For >20kg adults/pediatrics; CRRT + TPE + HP

  2. Citrate-ready: Dual-pump control, reduces bleeding, high-risk friendly

  3. Superior accuracy: Gravimetric balance, <1% error, long-term stability

  4. Maximum safety: 8 monitors, passive clamps, power-loss lock, alarms

  5. Easy operation: 1-touch prime, Chinese UI, modular lines, fast setup

  6. Flexible therapy: Pre/post-dilution, sequential, 10–450ml/min blood flow

  7. Certified: CFDA (20203100418), ISO, YY compliant


四、技术参数 / Technical Parameters

项目 Item中文 Chinese英文 English
型号 ModelAquarius (GE-F095-00-CN)Aquarius (GE-F095-00-CN)
注册证国械注进 20203100418CFDA 20203100418
适用体重≥20kg 成人 / 儿童≥20kg Adult/Pediatric
血流速10–450 mL/min10–450 mL/min
置换 / 透析液0–10000 mL/h0–10000 mL/h
滤过液0–12000 mL/h0–12000 mL/h
超滤率-100~+2000 mL/h(成人)-100~+2000 mL/h (Adult)
压力监测动脉 / 静脉 / 滤前 / 滤后Art/Ven/Pre-filter/Post-filter
空气监测超声 2.3MHz,1µL 灵敏2.3MHz ultrasonic, 1µL
加热35.0–39.0℃35.0–39.0℃
泵数量6 泵(血 / 滤过 / 置换 / 肝素 / 枸橼酸 / 钙)6 pumps
电源AC 220V±10%, 50Hz, 1.5kWAC 220V±10%, 50Hz, 1.5kW
尺寸 / 重量110×60×50cm / 125kg110×60×50cm / 125kg

五、使用方法 / Usage

中文

  1. 准备:接电 / 自检(约 5min)→ 安装管路 / 滤器 / 置换袋 → 自动预冲

  2. 选模式:CVVHDF/TPE/HP → 设血流、置换、超滤、肝素 / 枸橼酸参数

  3. 引血:低速启动(40–60ml/min)→ 稳定后调至目标流速 → 监测压力

  4. 治疗:实时监控平衡、压力、温度、报警 → 处理异常

  5. 结束:自动回血 → 停泵 → 卸管路 → 消毒 → 关机

English

  1. Prep: Power/self-test (~5min) → install lines/filter/bags → auto-prime

  2. Mode: Select CVVHDF/TPE/HP → set blood flow, replacement, UF, anticoagulant

  3. Initiate: Start low (40–60ml/min) → ramp to target → monitor pressures

  4. Treatment: Monitor balance, pressures, temp, alarms → troubleshoot

  5. Terminate: Auto-washback → stop pumps → remove lines → disinfect → shutdown


六、适应症 / Indications

中文

  • 急性肾损伤(AKI)伴容量过载、电解质紊乱

  • 慢性肾衰竭急性加重、高分解代谢

  • 重症感染、脓毒症、多器官衰竭(清除炎症因子)

  • 药物 / 毒物中毒、严重代谢酸中毒

  • 肝衰竭、高胆红素血症、自身免疫病(血浆置换)

  • 难治性心衰、严重水肿、容量超负荷

English

  • Acute kidney injury (AKI) with volume overload, electrolyte imbalance

  • Acute on chronic renal failure, hypercatabolism

  • Severe infection, sepsis, MODS (cytokine removal)

  • Drug/toxin intoxication, severe mmbedbolic acidosis

  • Liver failure, hyperbilirubinemia, autoimmune disease (TPE)

  • Refractory heart failure, severe edema, volume overload


七、禁忌症 / Contraindications

中文

  • 严重休克、顽固性低血压(无法耐受体外循环)

  • 活动性大出血、严重凝血功能障碍

  • 无法建立有效血管通路

  • 体重<20kg(婴幼儿禁用)

  • 对管路 / 滤器 / 抗凝剂严重过敏

  • 预期生命极短、不适合支持治疗

English

  • Severe shock/refractory hypotension (intolerance to ECC)

  • Active major bleeding, severe coagulopathy

  • Inability to establish vascular access

  • Weight <20kg (pediatric contraindication)

  • Severe hypersensitivity to lines/filter/anticoagulants

  • Terminal condition with very short life expectancy


八、注意事项 / Cautions

中文

  • 持证医护操作,严格遵医嘱与说明书

  • 治疗前自检、管路安装、漏血 / 气泡监测必须正常

  • 枸橼酸抗凝成人,监测离子钙、血气

  • 严禁擅自调整血流、超滤、置换等关键参数

  • 报警立即处理;空气 / 漏血 / 高压立即停泵、夹管

  • 定期校准传感器、更换电池、消毒管路接口

  • 体外循环血量不超过患者血容量 10%

English

  • Operate only byqualified staffper order & manual

  • Verify self-test, line install, air/blood leak monitors before use

  • Citrate anticoagulationadult only; monitor ionized Ca, blood gas

  • Donotadjust blood flow, UF, replacement without order

  • Respond to alarms immediately; stop/clamp on air/leak/high pressure

  • Calibrate sensors, replace battery, disinfect ports regularly

  • Extracorporeal volume≤10% of patient blood volume


九、存储条件 / Storage

中文

  • 环境温度:5–40℃

  • 相对湿度:30%–75%RH,无冷凝

  • 通风干燥、避光、防尘、防腐蚀气体

  • 运输:防震、防潮、防倒置、固定牢固

  • 长期存放:每月通电自检、保持干燥、保护传感器

English

  • Ambient temp:5–40°C

  • RH:30–75%, non-condensing

  • Ventilated, dry, dark, dust-free, no corrosive gases

  • Transport: shockproof, moisture-proof, upright, secured

  • Long-term: monthly self-test, dry, protect sensors


十、说明书核心信息 / Manual Highlights

中文

  • 6 泵模块化:支持 CRRT 全模式 + TPE+HP + 枸橼酸抗凝

  • 天平式平衡:精度<1%,24–72h 连续稳定

  • 无源安全夹:断电自动夹闭静脉管路,防空气 / 失血

  • 枸橼酸系统:双泵联动、钙反馈、自动纠偏,成人专用

  • 维护周期:每日自检、每周消毒、每月校准、每年大修

  • 适用人群:≥20kg,体外容量≤10% 患者血容量

  • 合规:符合 YY0645、ISO14971、CFDA 注册标准

English

  • 6-pump modular: Full CRRT + TPE + HP + citrate anticoagulation

  • Gravimetric balance: <1% accuracy, stable 24–72h

  • Passive clamps: Power-loss auto-clamp venous line

  • Citrate system: Dual-pump, calcium feedback, adult-only

  • Service: Daily self-test, weekly disinfection, monthly calibration

  • Patient: ≥20kg, ECC volume ≤10% blood volume

  • Compliance: YY0645, ISO14971, CFDA certified


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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