厂商直销唯美血栓弹力图仪TEG® 6s
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厂商直销唯美血栓弹力图仪TEG® 6s
桂经理19117326863微xin同号
管理类别
第二类
型号规格
TEG® 6s
结构及组成/主要组成成分
该产品主要由预温模块、加样模块、计时模块、样品传送及处理模块、电路控制模块、检测模块、显示模块、嵌入式系统，软件（版本号：1）和电源组成。
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，判断患者的凝血状态，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样本进行凝血功能分析。
一、工作原理 (Working Principle)
中文采用粘弹性监测技术，通过微流控一次性检测卡内悬挂血滴对外部振动的谐波响应，实时采集血液从凝固、收缩到纤溶全过程的粘弹性变化。血样加入卡内后，系统自动混合预制干试剂并进入检测腔；随血凝块形成，弹性模量与共振频率升高，仪器将振动频率变化转化为数值与曲线，输出 R、K、α、MA、LY30 等核心参数，完整反映凝血因子、纤维蛋白原、血小板及纤溶功能。EnglishUtilizes viscoelastic monitoring technology to real-time capture viscoelastic changes during blood clotting, retraction, and fibrinolysis via the harmonic response of a pendant blood drop in a disposable microfluidic cartridge. After sample addition, the system automatically mixes preloaded dried reagents and transfers to the test chamber. As clot ｆorms, elastic modulus and resonant frequency increase; the device converts vibration frequency changes into numerical values and curves, outputting key parameters (R, K, α, MA, LY30) to reflect coagulation factors, fibrinogen, platelet function, and fibrinolysis.
二、产品功能 (Functions)
中文
全流程凝血分析：同步检测凝血因子（R）、纤维蛋白形成（K/α）、血小板功能（MA）及纤溶活性（LY30），覆盖凝血全过程。
多项目并行检测：单卡可完成最多 4 项检测，支持常规 TEG、肝素酶对比、血小板图（PlateletMapping®）等组合。
自动化操作：卡内预装试剂，无需手动移液；扫码识别、自动混匀、样本分流，减少人为误差。
智能数据管理：内置 6.5 英寸触控屏，实时显示曲线与数值；支持 USB / 网络连接，数据可导出至 LIS/EMR，便于追溯。
质控与预警：内置质控流程，超限自动报警； Interpretation Guidance 模块可按院内规则生成解读提示，标准化报告。
English
Full Coagulation Analysis: Simultaneously assesses coagulation factors (R), fibrin ｆormation (K/α), platelet function (MA), and fibrinolytic activity (LY30) to cover the entire coagulation process.
Multi-Assay Parallel Testing: Up to 4 assays per cartridge; supports combinations of standard TEG, heparase comparison, and PlateletMapping®.
Automated Operation: Preloaded dried reagents in cartridges; no manual pipetting required: barcode scanning, automatic mixing, and sample 分流 minimize human error.
Smart Data Management: 6.5" touchscreen with real-time curves and values; USB/network connectivity for data export to LIS/EMR.
QC & Alerts: Built-in QC with automatic alerts; Interpretation Guidance module generates interpretation prompts per institutional guidelines for standardized reporting.
三、产品特点 (Product Features)
中文
便携一体化：体积小巧（约 175×257×270mm）、重量轻（4.2kg），带提手，适配急诊、ICU、手术室等床旁场景。
免试剂准备：一次性检测卡预装所有试剂，开箱即用，降低实验室准备成本与污染风险。
兼容：结果参数与传统 TEG 5000 一致，可直接沿用现有解读标准，无缝替换升级。
安全闭环：血样全程封闭在卡内，无暴露风险；耗材一次性使用，避免交叉感染。
快速出结果：最快 20 分钟出具报告，支持超时检测（最长 90 分钟），满足急危重症救治需求。
数据互联：支持 TEG Manager® 软件，远程访问设备与数据，适配医院信息化管理。
English
Portable All-in-One: Compact (175×257×270mm) and lightweight (4.2kg) with a handle; ideal for point-of-care settings (ED, ICU, OR).
No Reagent Prep: Disposable cartridges with preloaded dried reagents; ready-to-use, reducing lab prep costs and contamination risks.
Precision Compatible: Key parameters match traditional TEG 5000; directly use existing interpretation standards for seamless upgrade.
Safe Closed System: Blood sample fully enclosed in the cartridge with no exposure risk; single-use consumables prevent cross-contamination.
Fast Results: Reports in as little as 20 minutes, with up to 90-minute testing for critical care needs.
Data Connectivity: TEG Manager® software for remote device access and data integration with hospital IT systems。
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® 6s 血栓弹力图仪 TEG® 6s Hemostasis Analyzer
检测原理 粘弹性谐波监测 Viscoelastic Harmonic Monitoring
样本类型 枸橼酸 / 肝素化全血 Citrated/Heparinized Whole Blood
检测通道 单通道（单卡最多 4 项） Single-Channel (Up to 4 Assays/Cartridge)
核心参数 R、K、α 角、MA、LY30、CI R, K, Alpha Angle, MA, LY30, CI
出报告时间 最快 20 分钟（最长 90 分钟） Fastest 20 mins (Max 90 mins)
显示屏 6.5 英寸彩色触控屏 6.5" Color Touchscreen
数据接口 USB 2.0、以太网 USB 2.0, Ethernet
尺寸 (Dimensions) 175×257×270mm（宽 × 长 × 高） 175×257×270mm (W×L×H)
重量 (Weight) 约 4.2kg（9.4 磅） Approx. 4.2kg (9.4 lbs)
电源 (Power) 100–240V AC，50/60Hz；12V DC 输出 100–240V AC, 50/60Hz; 12V DC Output
最大功率 (Max Power) 60W 60W Max
工作环境 (Operating) 10–32℃，20–80% RH（无冷凝） 10–32°C, 20–80%RH (non-condensing)
存储环境 (Storage) -20–50℃，20–80% RH（无冷凝） -20–50°C, 20–80%RH (non-condensing)
认证 (Certifications) FDA、NMPA、CE FDA, NMPA, CE
五、使用方法 (Instructions for Use)
中文
开机与登录：连接电源，开机后通过用户名 / 密码登录；确认系统时间与日期准确。
准备检测卡：从 2–8℃冷藏环境取出密封包装的检测卡，核对类型、批号与有效期，撕开缺口开封。
插入检测卡：将检测卡（条码朝左）插入卡槽，仪器自动扫码识别并完成预检；确认检测类型无误后进入下一步。
加样：用移液枪或注射器向加样口加入枸橼酸 / 肝素化全血，至卡上刻度线或以上；无需精确体积，多余血样自动进入密封废液区。
启动检测：点击 “下一步” 开始检测；实时观察曲线变化，必要时可手动终止。
查看与导出结果：检测完成后，在结果页查看数值与曲线；可通过 USB 连接打印机打印报告，或通过网络导出至 LIS/EMR。
处理废弃物：检测完成后，按提示取出检测卡，立即作为生物危害废物规范处理；清洁设备表面。
English
Power On & Login: Connect power, log in with username/password; confirm system date and time.
Prepare Cartridge: Remove sealed cartridge from 2–8°C storage, verify type, lot, and expiration; tear open at notch.
Insert Cartridge: Insert cartridge (barcode left) into slot; auto-scan and pretest; confirm assay type and proceed.
Load Sample: Add citrated/heparinized whole blood to the sample port using a pipette/syringe, up to or above the marked line; precise volume not required (excess goes to sealed waste).
Start Test: Tap "Next" to begin; monitor curves in real time and manually stop if needed.
View & Export Results: Access values and curves upon completion; print via USB or export to LIS/EMR via network.
Dispose Properly: Remove cartridge upon prompt and dispose as biohazardous waste; clean device surfaces.
六、适应症 (Indications)
中文
急危重症出血：创伤、产科大出血、手术中 / 后出血，指导成分输血与止血治疗。
凝血功能异常筛查：肝病、抗凝 / 抗血小板治疗监测、凝血因子缺乏、纤溶亢进诊断。
心血管手术：心脏搭桥、瓣膜置换等术中凝血管理，减少输血用量与并发症。
特殊人群：新生儿、儿童、老年患者的凝血状态评估，优化个体化治疗。
肝素 / 抗血小板药物疗效评估：肝素耐药性判断、阿司匹林 / 氯吡格雷等抗血小板药效量化。
English
Critical Care Bleeding: Trauma, obstetric hemorrhage, intra/post-op bleeding to guide blood component transfusion and hemostatic therapy.
Coagulopathy Screening: Liver disease, anticoagulant/antiplatelet monitoring, coagulation factor deficiency, and hyperfibrinolysis diagnosis.
Cardiac Surgery: Intraoperative coagulation management for CABG, valve replacement, etc., to reduce transfusion volume and complications.
Special Populations: Coagulation assessment in neonates, children, and elderly to optimize individualized treatment.
Anticoagulant/Antiplatelet Monitoring: Heparin resistance assessment and quantitative antiplatelet efficacy (aspirin, clopidogrel, etc.).
七、禁忌症 (Contraindications)
中文
无绝对禁忌症，专业医护人员操作。
相对禁忌：严重溶血、脂血样本可能干扰结果；样本采集后超过 2 小时未检测，结果可靠性下降。
检测卡过期、包装破损或已开封未使用，禁止使用。
English
No Absolute Contraindications; for trained medical personnel only.
Relative: Severely hemolyzed/lipemic samples may interfere results; samples untested within 2 hours post-collection have reduced reliability.
Prohibited: Expired, damaged, or opened/unused cartridges.
八、注意事项 (Precautions)
中文
操作时必须佩戴无粉手套，接触血样后及时洗手；更换患者样本时更换新手套。
血样与检测卡均需在 2–30℃环境下操作；检测卡从冷藏取出后可直接使用，无需回温。
样本必须为完全真空采集的枸橼酸 / 肝素化全血，禁止使用凝血管、短采管。
检测过程中禁止移除检测卡；检测完成后，卡内残留血样为生物危害，需按规范处理。
设备需定期清洁消毒（每日 / 按院感要求）；年度维护需由 Haemonetics 授权技术人员执行。
禁止使用非原厂配件与检测卡，否则可能导致设备故障或结果偏差。
English
Wear powder-free gloves during operation; wash hands immediately after contact; change gloves between patients.
Handle samples and cartridges at 2–30°C; cartridges can be used directly from refrigeration without warming.
Samples must be fully vacuum-collected citrated/heparinized whole blood; clotted or short-drawn tubes are prohibited.
Do not remove the cartridge during testing; residual blood in the cartridge is biohazardous and must be disposed properly.
Clean and disinfect the device regularly (daily per infection control); annual maintenance by authorized Haemonetics technician.
Do not use non-OEM parts or cartridges; may cause device failure or inaccurate results.
九、存储条件 (Storage Conditions)
中文
设备：存储于 - 20～50℃、20～80% RH（无冷凝）环境，防潮防尘，远离强电磁干扰与腐蚀源。
检测卡：密封包装，2～8℃冷藏保存，禁止冷冻；有效期以包装标注为准，开封后立即使用。
运输：防震包装，温度范围 - 20～50℃，避免剧烈震动与阳光直射。
English
Device: Store at -20–50°C, 20–80%RH (non-condensing); protect from moisture, dust, strong EMI, and corrosives.
Cartridges: Sealed packaging, store at 2–8°C; do not freeze; use immediately after opening; expiration per label.
Transport: Shockproof packaging, -20–50°C; avoid impact and direct sunlight.
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：美国 Haemonetics, Inc.（泰蒙医疗）。
型号：TEG® 6s（系统编号：07-690）。
核心耗材：一次性检测卡（含预制干试剂）、质控卡。
执行标准：ISO 13485、IEC 60601-1/-2、FDA 510 (k)、NMPA 认证。
保修：主机1 年（不含耗材）。
使用权限：医疗机构内专业医护人员操作，需经厂家培训合格。
数据管理：支持 TEG Manager® 软件，数据加密存储，符合医疗信息安全规范。
English
Classification: Class III In Vitro Diagnostic (IVD) Medical Device.
Manufacturer: Haemonetics, Inc., USA.
Model: TEG® 6s (System No.: 07-690).
Key Consumables: Disposable assay cartridges (preloaded dried reagents), QC cartridges.
Compliance Standards: ISO 13485, IEC 60601-1/-2, FDA 510(k), NMPA Certified.
Warranty: 1 Year for main unit (excludes consumables).
Usage Restriction: For trained medical personnel only in healthcare settings; manufacturer training required.
Data Management: TEG Manager® software for encrypted data storage and compliance with medical inｆormation security 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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