厂家直供唯美血栓弹力图仪5000
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厂家直供唯美血栓弹力图仪5000
桂经理19117326863微xin同号
管理类别
第二类
型号规格
5000
结构及组成/主要组成成分
该产品主要由检测模块、机械传动模块、显示模块、电路控制模块、电源和随机软件（软件发布版本号：4）组成。
适用范围/预期用途
该产品基于对血液凝结过程中的物理特性分析，判断病人的凝血状态，与配套的检测试剂共同使用，在临床上用于对来源于人体全血、血浆或富含血小板的血浆样本进行凝血功能分析。
一、工作原理 (Working Principle)
中文采用经典的杯 - 针机械传感技术（旋转血栓弹力图法）。
将 0.36mL 全血样本置于 37℃恒温的样本杯中，样本杯以 4°45′倾角、每 10 秒 1 周的速度匀速旋转。
血液未凝固时呈液态，杯体旋转不带动静止的探测针；当凝血启动，纤维蛋白与血小板形成网状凝块，
将杯壁与探测针粘连，杯体的旋转运动便通过血凝块传递至探测针，产生扭力摆动。
仪器通过高精度扭力传感器实时捕捉摆动幅度与速度变化，将机械信号转化为电信号，
最终生成 TEG 曲线与 R、K、α 角、MA、LY30 等参数，完整反映凝血因子活化、纤维蛋白形成、
血小板聚集及纤溶的全过程。EnglishAdopts classic cup-and-pin mechanical sensing technology
(rotational thromboelastometry). A 0.36mL whole blood sample is placed in a 37°C
thermostatically controlled cup, which oscillates at an angle of 4°45′ with a
10-second cycle. In liquid state, cup rotation does not affect the stationary pin.
As clotting initiates, fibrin-platelet mesh ｆorms, bonding the cup and pin;
rotation is transmitted to the pin, creating torsional motion.
A high-precision sensor captures amplitude/speed changes, converting mechanical signals into
electrical outputs to generate TEG curves and parameters (R, K, α, MA, LY30), reflecting the
full coagulation cascade, fibrin ｆormation, platelet aggregation, and fibrinolysis.
二、产品功能 (Functions)
中文
全谱凝血分析：同步评估凝血因子（R）、纤维蛋白原（K/α）、血小板功能（MA）、纤溶活性（LY30），
实现凝血全貌检测。
多模式检测：支持高岭土标准检测（Kaolin）、快速 TEG（RapidTEG™）、功能性纤维蛋白原
（Functional Fibrinogen）、血小板图（PlateletMapping®）、肝素酶对比等多种检测方案。
床旁快速诊断：15–20 分钟出结果，实时指导术中 / 急诊凝血管理与成分输血。
药物疗效监测：评估肝素、低分子肝素、阿司匹林、氯吡格雷等抗凝 / 抗血小板药物效果。
智能数据管理：连接 TEG Manager® 软件，支持数据存储、报告打印、LIS/EMR 系统对接，
提供标准化解读提示。
双通道独立运行：2 个独立检测通道，可同时 / 分别进行不同项目检测，提升效率。
English
Comprehensive Coagulation Analysis: Simultaneously evaluates coagulation factors (R),
fibrinogen (K/α), platelet function (MA), and fibrinolytic activity (LY30) for full
hemostasis profiling.
Multi-Mode Assays: Supports Kaolin, RapidTEG™, Functional Fibrinogen, PlateletMapping®,
and heparinase comparison assays.
Rapid POC Diagnosis: Results in 15–20 mins for real-time guidance in OR/ER and transfusion
decisions.
Drug Monitoring: Quantifies efficacy of heparin, LMWH, aspirin, clopidogrel, and other
antithrombotic agents.
Smart Data Management: Integrates with TEG Manager® software for data storage, printing,
LIS/EMR connectivity, and standardized interpretation.
Dual Independent Channels: Two separate channels for simultaneous/sequential testing,
maximizing throughput.
三、产品特点 (Product Features)
中文
经典技术：杯 - 针机械传感，全球准，结果稳定可靠，临床数据积累丰富。
双通道高效：双通道独立控温、独立运行，支持并行检测，缩短等待时间。
操作简便：样本量微（0.36mL），手动加样后全自动检测，界面直观。
耗材安全：一次性无菌样本杯 / 针，封闭检测，无交叉感染风险。
稳定耐用：工业级设计，运行噪音低，适合实验室 / 手术室长期使用。
兼容性强：支持枸橼酸化 / 非枸橼酸化全血，适配多种临床场景。
合规认证：通过 FDA、CE、NMPA 认证，符合 ISO 13485、IEC 60601 标准。
English
Gold Standard Precision: Cup-and-pin mechanical sensing, globally validated with extensive
clinical data.
Dual-Channel Efficiency: Independent temperature control and operation for parallel testing,
reducing turnaround time.
User-Friendly: Minimal sample volume (0.36mL), fully automated after loading, intuitive
interface.
Safe Disposables: Sterile single-use cups/pins, closed system eliminates cross-contamination.
Robust Design: Industrial-grade, low noise, ideal for lab/OR long-term use.
Broad Compatibility: Works with citrated/non-citrated whole blood for versatile clinical use.
Regulatory Compliance: FDA, CE, NMPA cleared; meets ISO 13485, IEC 60601.
四、技术参数 (Technical Specifications)
表格
参数项 (Item) 中文参数 (CN Spec) 英文参数 (EN Spec)
型号 (Model) TEG® 5000 血栓弹力图仪 TEG® 5000 Hemostasis Analyzer
检测原理 杯 - 针旋转剪切弹力测量 Cup-and-Pin Rotational Shear Elasticity Measurement
检测通道 2 个独立通道 2 Independent Channels
样本类型 全血（枸橼酸化 / 肝素化） Whole Blood (Citrated/Heparinized)
样本量 0.36 mL 0.36 mL
控温精度 37 ± 0.1℃ 37 ± 0.1°C
杯体运动 4°45′倾角，10 秒 / 周 4°45′ Oscillation, 10 sec/Cycle
检测时间 常规：15–30 min；快速：8–12 min Standard: 15–30 min; Rapid: 8–12 min
核心参数 R、K、α 角、MA、LY30、CI、EPL R, K, Alpha Angle, MA, LY30, CI, EPL
尺寸 (W×D×H) 290 × 220 × 180 mm 290 × 220 × 180 mm
重量 5.4 kg (12 lb) 5.4 kg (12 lb)
电源 100–240V AC, 50/60Hz, 46W 100–240V AC, 50/60Hz, 46W
工作环境 15–30℃，20–80% RH（无冷凝） 15–30°C, 20–80%RH (non-condensing)
存储环境 -30–50℃，20–80% RH（无冷凝） -30–50°C, 20–80%RH (non-condensing)
数据接口 RS-232、USB RS-232, USB
注册证 国械注进 NMPA Reg No.
五、使用方法 (Instructions for Use)
中文
开机预热：连接电源开机，仪器自动预热≤5 分钟；通道温度达 37℃后准备就绪。
耗材准备：取出一次性无菌杯、针、试剂，核对批号与有效期；将杯装入杯座，针挂于传感器悬丝。
样本处理：采集静脉全血（枸橼酸钠抗凝）；按检测项目加入对应激活剂（如高岭土），
混匀后静置 3–5 分钟。
加样检测：用移液枪吸取 0.36mL 样本注入样本杯；立即关闭通道盖，启动检测程序。
实时监测：仪器自动绘制曲线、计算参数；可在屏幕查看实时数据与图形。
结果处理：检测结束后，自动生成报告；可打印、保存或传输至 LIS 系统。
术后清洁：取出并丢弃一次性杯 / 针；用 75% 酒精擦拭通道表面；定期执行质控与维护。
English
Power-On & Warm-Up: Connect power, auto warm-up ≤5 mins; ready when channels reach 37°C.
Consumable Prep: Load sterile single-use cup/pin; verify lot/expiry; mount pin on sensor.
Sample Prep: Collect venous whole blood (citrated); add activator (kaolin), mix, incubate
3–5 mins.
Load & Start: Pipette 0.36mL sample into cup; close lid, start assay.
Real-Time Monitor: Instrument auto-generates curves/parameters; view on-screen data/graphs.
Result Management: Auto-generates report upon completion; print, save, or transmit to LIS.
Clean-Up: Discard cup/pin; wipe channels with 75% alcohol; perｆorm regular QC/maintenance.
六、适应症 (Indications)
中文
手术凝血管理：心血管、骨科、神经外科、肝移植等大手术，指导术中止血与输血。
创伤 / 急诊出血：严重创伤、失血性休克、产科大出血，快速判断低凝 / 纤溶亢进。
凝血疾病诊断：血友病、肝病、DIC、先天性纤维蛋白原缺乏症的功能评估。
抗凝 / 抗血小板监测：肝素 / 华法林疗效、耐药性判断；抗血小板药物（阿司匹林 / 氯吡格雷）
效果量化。
血栓风险预测：术后、肿瘤、肾病综合征患者的高凝状态与血栓风险评估。
特殊人群：新生儿、儿童、老年患者凝血功能评估，避免过度输血。
English
Surgical Hemostasis: Cardiac, orthopedic, neurosurgery, liver transplant; guide intra-op
hemostasis/transfusion.
Trauma/Emergency Bleeding: Severe trauma, hemorrhagic shock, obstetric hemorrhage; rapid
diagnosis of hypocoagulability/fibrinolysis.
Coagulopathy Diagnosis: Hemophilia, liver disease, DIC, congenital fibrinogen deficiency.
Antithrombotic Monitoring: Heparin/warfarin efficacy/resistance; antiplatelet
(aspirin/clopidogrel) quantification.
Thrombosis Risk: Post-op, oncology, nephrotic syndrome hypercoagulability assessment.
Special Populations: Neonates, pediatrics, geriatrics; precise coagulation assessment
to avoid over-transfusion.
七、禁忌症 (Contraindications)
中文
绝对禁忌：无绝对禁忌症，经培训医护人员操作。
相对禁忌：
严重溶血、脂血、黄疸样本，结果可能受干扰。
样本采集后超过 2 小时未检测，凝血活性下降。
样本凝固、有凝块、气泡过多，禁止上机。
耗材过期、包装破损、污染，严禁使用。
English
Absolute: No absolute contraindications; for trained medical personnel only.
Relative:
Severely hemolyzed, lipemic, or icteric samples may cause interference.
Samples untested >2 hrs post-collection have reduced activity.
Clotted, partially clotted, or bubbly samples are prohibited.
Expired, damaged, or contaminated consumables must not be used.
八、注意事项 (Precautions)
中文
无菌操作：全程无菌，耗材一次性使用，防止生物污染。
样本规范：采血顺畅无凝块，避免剧烈震荡；室温（15–25℃）保存，2 小时内检测。
加样：严格 0.36mL 样本量，气泡会导致结果异常。
温度控制：确保 37℃恒温，温度偏差影响凝血速度。
质控合规：每日开机执行质控（Ⅰ/Ⅱ 级质控品），合格后方可检测。
设备维护：每日清洁通道；每月校准传感器；年度厂家工程师维护。
结果解读：TEG 为功能检测，需结合 PT、APTT、血小板计数等综合判断。
安全防护：佩戴手套、护目镜，样本按生物危害物处理。
English
Aseptic Technique: Full sterile protocol; single-use consumables to prevent contamination.
Sample Handling: Smooth venipuncture, no clots; store at 15–25°C, test within 2 hrs.
Precise Loading: Strict 0.36mL volume; bubbles cause erroneous results.
Temperature Control: Maintain 37°C; deviations alter clot kinetics.
Quality Control: Run daily Level I/II QC; test only after QC pass.
Device Maintenance: Daily channel cleaning; monthly sensor calibration; annual factory
service.
Result Interpretation: Functional assay; correlate with PT, APTT, platelet count.
Safety: Wear gloves/goggles; dispose samples as biohazard.
九、存储条件 (Storage Conditions)
中文
仪器存储：温度 - 30～50℃，湿度 20～80% RH（无冷凝）；干燥、防尘、防震、远离强电磁与腐蚀源。
耗材存储：
一次性杯 / 针、干试剂：15～30℃室温密封保存，禁止冷冻。
液体试剂（CaCl₂）：2～8℃冷藏，避免阳光直射。
有效期：包装标注 2 年；开封后立即使用。
运输：防震包装，温度 - 30～50℃，避免剧烈碰撞与高温。
English
Device Storage: -30–50°C, 20–80%RH (non-condensing); dry, dust/shock/vibration/EMI/
corrosive-free.
Consumables Storage:
Cups/pins/dried reagents: 15–30°C sealed; do not freeze.
Liquid reagents (CaCl₂): 2–8°C, protect from light.
Shelf Life: 2 years; use immediately after opening.
Transport: Shockproof packaging, -30–50°C; avoid impact/heat.
十、说明书核心信息 (Manual Core Inｆormation)
中文
产品分类：三类体外诊断医疗器械（IVD）。
制造商：Haemonetics Corporation（原 Haemoscope），美国。
系统组成：TEG® 5000 主机、专用杯 / 针耗材、质控品、TEG Manager® 软件。
注册认证：FDA 510 (k)、CE、NMPA（国械注进）。
执行标准：ISO 13485、IEC 60601-1/-2。
保修：主机1 年有限保修（不含耗材、人为损坏）。
使用权限：Rx（处方），医疗机构内专业人员操作。
废弃处理：耗材按生物医疗废物处置；设备按电子废弃物规范回收。
English
Classification: Class III In Vitro Diagnostic (IVD) Medical Device.
Manufacturer: Haemonetics Corp. (ｆormerly Haemoscope), USA.
System Includes: TEG® 5000 analyzer, cups/pins, controls, TEG Manager® software.
Regulatory Clearance: FDA 510(k), CE, NMPA.
Standards: ISO 13485, IEC 60601-1/-2.
Warranty: 1-Year limited warranty (excludes consumables/misuse).
Restriction: Rx only; for use by trained professionals in healthcare facilities.
Disposal: Consumables as biohazard; device per e-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.
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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