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厂家直供爱德华血流动力学监护仪HEMKITSGOX2
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厂家直供爱德华血流动力学监护仪HEMKITSGOX2
桂经理19117326863微xin同号
产品名称 病人监护仪Hemodynamic Modularized Multi-parameter Monitoring Platｆorm
管理类别 第三类
型号规格 HEMKITSGOX2
结构及组成/主要组成成分 该产品由主机（HEM1）、Swan-Ganz漂浮导管模块 （HEMSGM10）、血氧测定缆线（HEMOXSC100）、压力测定缆线（HEMPSC100）、脑部与组织血氧监测模块（HEMTOM10）、脑部与组织血氧监测电缆（HEMFSM10）、电池组（HEMBAT10）、病人电缆（70CC2）、压力从属缆线（70ANH、70ANHS、70ANM5、70ANS）、ECG监护仪从属缆线（64EKGE1、64EKH）、浴温注射液温度探头（9850A）、嵌入式注射液温度探头（93522）组成。
适用范围/预期用途 该产品是模块化血流动力学多参数监测平台，适合训练有素的临床医生在医院重症监护环境中使用。 当主机和Swan-Ganz漂浮导管模块与爱德华漂浮导管配合使用时，该产品用于需要监护心排量（持续心排量 Continuous C.O.和间歇心排量 intermittent C.O.）以及衍生血流动力学参数的成人和小儿重症患者。 当主机和血氧测定缆线与爱德华血氧导管一起使用时，用于需要监护混合静脉血氧饱和度SvO2、中心静脉血氧饱和度ScvO2以及衍生血流动力学参数的成人和小儿重症患者。 当主机和压力测定缆线与爱德华一次性使用压力传感器、心排量及压力监测传感器配合使用时，用于需要监测中心静脉压CVP、平均动脉压MAP等参数及衍生血流动力学参数的成人重症患者、以及需要持续评估心脏功能、液体状态、血管阻力和压力之间平衡的危重患者，可被用于测量与围手术期目标导向治疗相结合的血流动力学参数。 当主机和脑部与组织血氧监测模块、脑部与组织血氧监测电缆与爱德华脑部与区域血氧监测传感器配合使用时，该产品用于需要监护脑部血氧饱和度、组织血氧饱和度StO2参数的成人和小儿患者。
一、工作原理 (Working Principle)
中文通过配套的 Swan-Ganz 肺动脉导管或爱德华血氧中心静脉导管，采用热稀释法测量心输出量（C.O.），并结合光学传感技术监测静脉血氧饱和度（SvO₂/ScvO₂）。设备采集压力、温度、血氧等生理信号，经模块处理与算法分析，实时计算并显示连续 / 间歇心排量、右心室功能、血管阻力、氧供需等全套血流动力学参数。
EnglishMeasures cardiac output (C.O.) via thermodilution method using compatible Swan-Ganz pulmonary artery catheters or Edwards oximetry central venous catheters, and monitors venous oxygen saturation (SvO₂/ScvO₂) through optical sensing. It collects physiological signals (pressure, temperature, oximetry), processes via modules and algorithms, then calculates and displays real-time comprehensive hemodynamic parameters including continuous/intermittent C.O., right ventricular function, vascular resistance, oxygen supply/demand.
二、产品功能 (Functions)
中文
心功能监测：连续 / 间歇心输出量（CCO/ICO）、心指数（CI）、每搏量（SV/SVI）、右心室射血分数（RVEF）、右心室舒张末容积（RVEDV）
血氧监测：混合静脉血氧饱和度（SvO₂）、中心静脉血氧饱和度（ScvO₂）、氧供（DO₂）、氧耗（VO₂）
压力监测：肺动脉压（PAP）、肺毛细血管楔压（PCWP）、中心静脉压（CVP）、血压（BP）
血管阻力：体循环阻力（SVR/SVRI）、肺循环阻力（PVR/PVRI）
临床辅助：多界面可视化（仪表盘 / 趋势图 / 决策树）、参数报警、数据存储与回顾、HIS 系统无缝对接
English
Cardiac Function：Continuous/Intermittent Cardiac Output (CCO/ICO), Cardiac Index (CI), Stroke Volume (SV/SVI), Right Ventricular Ejection Fraction (RVEF), Right Ventricular End-Diastolic Volume (RVEDV)
Oximetry：Mixed Venous Oxygen Saturation (SvO₂), Central Venous Oxygen Saturation (ScvO₂), Oxygen Delivery (DO₂), Oxygen Consumption (VO₂)
Pressure：Pulmonary Artery Pressure (PAP), Pulmonary Capillary Wedge Pressure (PCWP), Central Venous Pressure (CVP), Blood Pressure (BP)
Vascular Resistance：Systemic Vascular Resistance (SVR/SVRI), Pulmonary Vascular Resistance (PVR/PVRI)
Clinical Support：Multi-interface visualization (dashboard/trend/decision tree), parameter alarms, data storage/recall, seamless HIS integration
三、产品特点 (Features)
中文
模块化设计：主机兼容 Swan-Ganz 模块、血氧模块、组织血氧模块，灵活扩展
高清触控：10.1 英寸彩色触摸屏，多界面直观显示
双供电模式：内置可热插拔电池（续航≥4h）+ 外接电源
数据安全：加密通讯、自动存储≥72h 趋势、支持数据导出
稳定：热稀释 + 光学双技术，抗干扰强，测量误差 <±5%
临床决策：内置氧供需分析、血流动力学决策树，辅助快速判断
English
Modular Design：Host compatible with Swan-Ganz, oximetry, tissue oximetry modules for flexible expansion
High-Definition Touch：10.1-inch color touchscreen, intuitive multi-interface display
Dual Power：Hot-swappable internal battery (≥4h) + external power supply
Data Security：Encrypted communication, ≥72h trend auto-storage, data export support
Accuracy & Stability：Dual thermodilution+optical technology, strong anti-interference, measurement error <±5%
Clinical Decision Support：Built-in oxygen supply-demand analysis, hemodynamic decision tree for rapid judgment
四、技术参数 (Specifications)
中文
主机：型号 HEM1；尺寸 406×274×61mm；重量 4.7kg
显示屏：10.1 英寸 LCD，分辨率 1280×800
电源：AC 100-240V 50/60Hz；DC 14.4V 锂电池
测量参数
心输出量：1-15L/min，精度 ±5%
血氧饱和度：0-100%，精度 ±2%
压力范围：-50~150mmHg，精度 ±1mmHg
温度：25-43℃，精度 ±0.1℃
数据存储：≥72 小时连续趋势数据
通讯：以太网、WiFi、RS232，支持 HL7 协议
English
Host：Model HEM1; Dimensions 406×274×61mm; Weight 4.7kg
Display：10.1-inch LCD, Resolution 1280×800
Power：AC 100-240V 50/60Hz; DC 14.4V Li-ion Battery
Measured Parameters
Cardiac Output: 1-15L/min, Accuracy ±5%
Oxygen Saturation: 0-100%, Accuracy ±2%
Pressure Range: -50~150mmHg, Accuracy ±1mmHg
Temperature: 25-43℃, Accuracy ±0.1℃
Data Storage：≥72 hours continuous trend data
Communication：Ethernet, WiFi, RS232, HL7 protocol supported
五、使用方法 (Instructions for Use)
中文
开机自检：连接电源 / 电池，开机自动自检，通过后进入主界面
模块安装：插入 Swan-Ganz / 血氧模块，连接对应导管电缆
患者连接：无菌操作下置入导管，连接压力 / 血氧传感器，校零定标
参数设置：输入患者信息（身高 / 体重 / 性别），设置报警上下限
测量启动：选择连续心输出量（CCO）或热稀释法（ICO）测量
数据监测：实时查看参数、趋势图，异常时声光报警
关机流程：停止测量→断开患者连接→清洁消毒→正常关机
English
Power-On Self-Test：Connect power/battery, auto self-test on startup, enter main interface after pass
Module Installation：Insert Swan-Ganz/oximetry modules, connect corresponding catheter cables
Patient Connection：Insert catheter under aseptic technique, connect pressure/oximetry sensors, zero calibration
Parameter Setup：Input patient info (height/weight/gender), set alarm limits
Start Measurement：Select Continuous Cardiac Output (CCO) or Thermodilution (ICO)
Data Monitoring：Real-time parameter/trend viewing, audible/visual alarms for abnormalities
Shutdown Procedure：Stop measurement→Disconnect patient→Clean/disinfect→Proper shutdown
六、适应症 (Indications)
中文适用于成人及儿童重症患者的血流动力学监测：
急性心衰、心肌梗死、心源性休克
各类休克（低血容量 / 感染性 / 心源性）的容量管理
重大手术（心外科 / 神经外科 / 器官移植）术中术后监测
严重 ARDS、肺动脉高压、多器官功能衰竭
需要监测 SvO₂/ScvO₂、心输出量及衍生参数的危重症
EnglishFor hemodynamic monitoring in adult and pediatric critically ill patients:
Acute heart failure, myocardial infarction, cardiogenic shock
Volume management in all types of shock (hypovolemic/septic/cardiogenic)
Intraoperative/postoperative monitoring in major surgeries (cardiac/neuro/transplant)
Severe ARDS, pulmonary hypertension, multiple organ failure
Critical illnesses requiring SvO₂/ScvO₂, cardiac output and derivative parameters monitoring
七、禁忌症 (Contraindications)
中文
导管插入部位存在感染、血栓、血管损伤
严重出血倾向、凝血功能障碍（抗凝禁忌）
右心人工瓣膜、三尖瓣严重畸形、心内肿瘤
对导管材料（聚氨酯 / 聚氯乙烯）过敏
无法配合或禁忌中心静脉 / 肺动脉置管的患者
English
Infection, thrombosis, vascular injury at catheter insertion site
Severe bleeding tendency, coagulation disorders (anticoagulation contraindication)
Right heart prosthetic valves, severe tricuspid malｆormation, intracardiac tumors
Allergy to catheter materials (polyurethane/PVC)
Patients unable to cooperate or contraindicated for central venous/pulmonary artery catheterization
八、注意事项 (Precautions)
中文
专业操作：受过培训的医护人员在 ICU / 手术室使用
无菌操作：导管置入、护理严格无菌，预防感染
校零校准：每次测量前压力传感器必须校零
导管维护：定时冲管，避免堵塞 / 血栓 / 感染
报警处理：报警时立即核查，先排除故障再处理病情
电磁干扰：远离高频电刀、MRI 等强电磁设备
电池安全：勿拆解 / 短路 / 高温，定期充放电维护
English
Professional Operation：Only for trained medical staff in ICU/operating room
Aseptic Technique：Strict sterility for catheter insertion/care to prevent infection
Zero Calibration：Pressure sensors must be zeroed before each measurement
Catheter Maintenance：Regular flushing to prevent occlusion/thrombosis/infection
Alarm Management：Immediate check on alarm, troubleshoot first then treat condition
EMI Protection：Keep away from strong electromagnetic devices (electrotome/MRI)
Battery Safety：No disassembly/short circuit/high temperature, regular charge/discharge maintenance
九、存储条件 (Storage Conditions)
中文
环境温度：-20℃ ~ +55℃
相对湿度：≤80%，无冷凝
大气压力：500 ~ 1060hPa
环境要求：干燥、通风、清洁、无腐蚀性气体
运输条件：同存储，避免剧烈震动 / 碰撞 / 阳光直射
English
Temperature：-20℃ ~ +55℃
Relative Humidity：≤80%, non-condensing
Atmospheric Pressure：500 ~ 1060hPa
Environment：Dry, ventilated, clean, no corrosive gases
Transportation：Same as storage, avoid severe vibration/collision/direct sunlight
十、说明书核心信息 (Manual Core Inｆormation)
中文
组成：主机 (HEM1)+Swan-Ganz 模块 + 血氧模块 + 电池 + 各类电缆 / 探头
安全分类：I 类 CF 型、可移动设备、连续运行
维护周期：每月自检、每年校准、耗材一次性使用
保修：主机 1 年，模块 / 配件 6 个月
** disposal**：按医疗电子废弃物法规处理
English
Registration：NMPA Approval 20183070254; Manufacturer: Edwards Lifesciences LLC
Composition：Host(HEM1)+Swan-Ganz Module+Oximetry Module+Battery+Various Cables/Probes
Safety Classification：Class I CF type, movable equipment, continuous operation
Maintenance：Monthly self-test, annual calibration, single-use consumables
Warranty：1 year for host, 6 months for modules/accessories
Disposal：Dispose per medical electronic waste regulations
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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