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厂商供应美国海伦娜ACT即时凝血分析仪ActalykeXL
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厂商供应美国海伦娜ACT即时凝血分析仪ActalykeXL
桂经理19117326863微xin同号
管理类别
第二类
型号规格
Actalyke XL
结构及组成/主要组成成分
触摸显示屏、检测室、打印机、中央处理器、MAX-ACT专用规格检测试管、软件（发布版本：V 1.7）。
适用范围/预期用途
该规格用于实验室进行激活全血凝固时间（ACT）检测。
即时凝血分析仪 Actalyke XL（ACT）
一、工作原理｜Working Principle
中文
采用两点磁阻式凝血检测（0° 与 90° 双探测器）+ 恒温孵育原理。含激活剂（硅藻土 / 高岭土 / 玻璃珠）与内置磁珠的 ACT 采血管加入全血后，置入分析仪 36.5–37.5℃恒温槽旋转混匀。激活剂启动内源性凝血途径，纤维蛋白逐渐形成并包裹磁珠；当凝血发生时，磁珠随纤维蛋白网移动，从 0° 探测器向 90° 探测器位移，达到 46° 阈值时双探测器协同判定凝血终点，自动计时并输出 ACT 值。该设计可早期捕捉纤维蛋白形成，受高肝素化、血液稀释影响更小，结果更稳定。
English
Uses two‑point magnetoresistive clot detection (0° & 90° dual detectors) + constant‑temperature incubation. Whole blood is added to an ACT tube containing activator (celite/kaolin/glass beads) and an internal magnetic bead, then placed into the analyzer’s 36.5–37.5°C heating block for rotation and mixing. The activator initiates the intrinsic coagulation pathway; fibrin ｆorms and entraps the bead. As clotting occurs, the bead moves from the 0° detector toward the 90° detector. When it reaches the 46° threshold, dual detectors confirm the endpoint, automatically timing and reporting the ACT value. This design detects early fibrin ｆormation, is less affected by high heparinization and hemodilution, and delivers more reliable results.
二、产品功能｜Product Functions
中文
ACT 检测：全血激活凝血时间（ACT）即时检测，监测中高剂量肝素抗凝效果。
多激活剂兼容：适配硅藻土、高岭土、玻璃珠、混合激活剂（MAX‑ACT）等多种 ACT 采血管。
恒温控制：36.5–37.5℃孵育，保证检测条件稳定。
数据管理：患者信息录入、结果存储、质控管理、多级权限（操作 / 设置 / 管理员）。
结果输出：内置热敏打印、RS232 / 射频传输、软盘存储、条码扫描（选配）。
质控保障：内置生物与电子质控，质控锁定功能，确保结果合规。
床旁适用：便携式设计，适用于手术室、导管室、透析室、ICU 等床旁场景。
English
ACT Testing：Point‑of‑care whole blood Activated Clotting Time (ACT) measurement to monitor moderate‑to‑high heparin anticoagulation.
Multi‑Activator Compatibility：Works with celite, kaolin, glass‑bead, and blended activator (MAX‑ACT) ACT tubes.
Temperature Control：Precise 36.5–37.5°C incubation for stable testing conditions.
Data Management：Patient data entry, result storage, QC management, three security access levels (operator/setup/admin).
Result Output：Built‑in thermal printer, RS232/RF transmission, floppy disk storage, optional barcode reader.
QC Assurance：Internal biological & electronic QC, QC lockout for compliance.
POC Ready：Portable design for OR, cath lab, dialysis, ICU, and other bedside settings.
三、产品特点｜Product Features
中文
两点检测技术：0°/90° 双探测器，46° 阈值判定，早期捕捉凝血，抗干扰强。
双通道设计：双检测位，可同时 / 先后检测，提升效率。
触控大屏：3.2×4 英寸彩色 LCD 触摸屏，操作直观、无需培训。
便携模块化：整机 6.8kg（含打印机），宽 × 高 × 深 27.2×20.3×30.5cm，移动便捷。
宽电压适配：85–265V AC、47–63Hz，全球通用，内置可充电电池（选配）。
质控完善：生物 + 电子双质控，质控锁定，符合 CLIA 中度复杂、NCCLS‑POCT 标准。
数据互通：多方式输出（打印 / 传输 / 存储），支持条码录入，适配 LIS 系统。
操作简便：一键启动，自动计时、判读、打印，无需人工干预。
English
Two‑Point Detection：0°/90° dual detectors, 46° threshold for early clot detection and high anti‑interference.
Dual‑Channel：Two test wells for simultaneous/sequential testing, improving efficiency.
Touchscreen：3.2×4 inch color LCD touchscreen for intuitive operation with minimal training.
Portable & Modular：6.8kg (with printer), 27.2×20.3×30.5cm (W×H×D), easy to transport.
Wide Voltage：85–265V AC, 47–63Hz, global compatibility; optional rechargeable battery.
Comprehensive QC：Biological + electronic QC, QC lockout; CLIA Moderate Complexity, NCCLS‑POCT compliant.
Data Connectivity：Multiple output (print/transfer/storage), barcode entry, LIS integration.
Simple Operation：One‑touch start, automatic timing, interpretation, and printing with no manual intervention.
四、技术参数｜Technical Parameters
中文
表格
参数项 详情
产品型号 Actalyke XL（Helena Laboratories）
检测项目 全血激活凝血时间（ACT）
测量范围 0–1500 秒（临床常用 90–1500 秒）
肝素监测 0–10U/mL，线性良好
检测原理 两点磁阻式（0°/90° 双探测器，46° 阈值）
孵育温度 36.5℃–37.5℃（±0.5℃）
检测通道 双通道（2 个检测位）
采血管兼容 Actalyke、MAX‑ACT、Hemochron 系列 ACT 管（硅藻土 / 高岭土 / 玻璃珠 / 混合激活剂）
显示界面 3.2×4 英寸彩色 LCD 触摸屏
整机尺寸 27.2×20.3×30.5cm（W×H×D）
整机重量 6.8kg（含内置打印机）
供电方式 AC 85–265V，47–63Hz；可选配可充电电池
操作环境 温度 15℃–30℃，相对湿度 10%–80%，无冷凝
数据输出 内置热敏打印、RS232、RF 无线、3.5 英寸软盘；可选条码扫描
质控功能 生物质控、电子质控、质控锁定、三级用户权限
合规认证 CLIA 中度复杂、CE、NCCLS‑POCT 1‑A compliant
English
表格
Parameter Details
Model Actalyke XL (Helena Laboratories)
Test Item Whole Blood Activated Clotting Time (ACT)
Measurement Range 0–1500 seconds (clinical: 90–1500s)
Heparin Monitoring 0–10U/mL, excellent linearity
Detection Principle Two‑point magnetoresistive (0°/90° dual detectors, 46° threshold)
Incubation Temp 36.5°C–37.5°C (±0.5°C)
Test Channels Dual‑channel (2 test wells)
Tube Compatibility Actalyke, MAX‑ACT, Hemochron ACT tubes (celite/kaolin/glass‑bead/blended activator)
Display 3.2×4 inch color LCD touchscreen
Dimensions 27.2×20.3×30.5cm (W×H×D)
Weight 6.8kg (with built‑in printer)
Power AC 85–265V, 47–63Hz; optional rechargeable battery
Operating Environment 15°C–30°C, 10%–80% RH, non‑condensing
Data Output Built‑in thermal printer, RS232, RF, 3.5” floppy; optional barcode reader
QC Functions Biological QC, electronic QC, QC lockout, three user levels
Certifications CLIA Moderate Complexity, CE, NCCLS‑POCT 1‑A compliant
五、使用方法｜Instructions for Use
中文
开机准备：连接电源 / 安装电池，开机自检；进入主界面，设置日期、时间、操作员权限。
质控检测：每日运行生物 / 电子质控，质控通过后方可检测患者样本；质控失败需排查后重试。
样本采集：静脉采血 2mL，注入 ACT 采血管，立即颠倒混匀 8–10 次，避免气泡。
上机检测：将采血管插入检测位，关闭舱门；触摸屏选择检测模式，一键启动，仪器自动孵育、旋转、检测、计时。
结果读取：检测完成自动打印 / 显示 ACT 值；记录患者信息、结果、检测时间。
术后处理：取出采血管，按医疗废物处理；清洁检测位与触摸屏，关机或待机。
数据管理：导出 / 传输结果至 LIS；定期备份数据，维护质控记录。
English
Startup：Connect power/install battery, perｆorm self‑test; set date, time, operator access on main screen.
QC Testing：Run biological/electronic QC daily; patient testing only after passing QC; troubleshoot and repeat if QC fails.
Sample Collection：Draw 2mL venous blood, add to ACT tube, invert 8–10 times immediately to mix, avoid bubbles.
Testing：Insert tube into test well, close door; select mode on touchscreen, start with one touch; instrument incubates, rotates, detects, and times automatically.
Result Review：ACT value printed/displayed automatically; document patient info, result, and time.
Post‑Test：Remove tube, dispose as medical waste; clean test wells and screen; power off or standby.
Data Management：Export/transfer results to LIS; back up data regularly, maintain QC records.
六、适应症｜Indications
中文
心血管手术：体外循环（CPB）、冠脉搭桥、瓣膜置换术中肝素抗凝监测与鱼精蛋白中和效果评估。
介入治疗：心导管、PCI、电生理手术中 ACT 监测，指导肝素剂量调整。
血液透析：透析过程中抗凝监测，预防凝血与出血并发症。
ICU / 急诊：危重患者肝素抗凝、ECMO 支持、血栓性疾病的凝血功能监测。
其他手术：神经外科、骨科大手术等需中高剂量肝素抗凝的术中监测。
English
Cardiac Surgery：Monitor heparin anticoagulation and protamine reversal during cardiopulmonary bypass (CPB), CABG, and valve replacement.
Interventional Procedures：ACT monitoring during cardiac catheterization, PCI, and EP studies to guide heparin dosing.
Hemodialysis：Anticoagulation monitoring during dialysis to prevent clotting and bleeding.
ICU/ED：Coagulation monitoring for critically ill patients on heparin, ECMO, or thrombotic disorders.
Other Surgeries：Intraoperative monitoring for neurosurgery, major orthopedics, and other procedures requiring moderate‑to‑high heparin.
七、禁忌症｜Contraindications
中文
无绝对禁忌症；相对禁忌：严重凝血因子缺乏、弥散性血管内凝血（DIC）、严重血小板减少（＜50×10⁹/L），结果仅供参考，需结合临床综合判断。
样本严重溶血、脂血、黄疸，可能导致结果偏差，不宜检测。
采血管激活剂失效、过期、污染，禁止使用。
仪器未通过质控、故障报警时，严禁检测患者样本。
English
No absolute contraindications; relative contraindications: severe coagulation factor deficiency, DIC, severe thrombocytopenia (<50×10⁹/L). Results are for reference only; correlate with clinical status.
Severe hemolysis, lipemia, or icterus may cause inaccurate results; avoid testing.
Do not use expired, contaminated, or inactive activator tubes.
No patient testing if QC fails or instrument alarms; resolve issues first.
八、注意事项｜Precautions
中文
人员资质：经培训的医护 / 检验人员操作，熟悉操作手册与质控流程。
样本规范：采血后立即混匀，避免凝血；样本室温放置≤5 分钟，不可冷藏 / 冷冻。
采血管要求：使用匹配的 ACT 采血管，检查有效期、完整性，禁止重复使用。
仪器维护：每日清洁检测位、触摸屏；定期校准温度、探测器；及时更换打印纸与保险丝。
质控管理：严格执行每日质控，失控立即停止检测，排查原因并记录。
结果解读：ACT 值受肝素剂量、体温、血液稀释、凝血功能、药物影响，需结合临床判断。
安全操作：防止样本溅洒，生物安全防护；仪器可靠接地，避免电磁干扰。
故障处理：出现报警 / 异常结果，查阅手册或联系厂家，禁止自行拆卸维修。
English
Operator Qualification：For trained medical/lab personnel only; familiar with manual and QC protocols.
Sample Handling：Mix immediately after draw; room temp ≤5 minutes; do not refrigerate/freeze.
Tube Requirements：Use compatible ACT tubes; check expiry and integrity; single‑use only.
Instrument Maintenance：Daily cleaning of wells and screen; periodic calibration of temperature and detectors; replace paper and fuses as needed.
QC Compliance：Run daily QC; stop testing if out‑of‑control, investigate, and document.
Result Interpretation：ACT affected by heparin, temperature, hemodilution, coagulopathy, and medications; correlate clinically.
Safety：Biosafety precautions for blood samples; proper grounding, avoid EMI.
Troubleshooting：Refer to manual or contact manufacturer for alarms/errors; do not disassemble.
九、存储条件｜Storage Conditions
中文
仪器存储：干燥、通风、清洁环境，温度 15℃–30℃，相对湿度 10%–80%，无腐蚀性气体、强电磁干扰。
采血管存储：2℃–8℃冷藏，避光、密封保存，避免冻结；有效期内使用，过期禁用。
运输条件：温度‑20℃–45℃，避免剧烈震动、雨淋、暴晒；仪器运输需固定防护。
耗材存储：打印纸、保险丝等耗材常温干燥保存，防潮、防尘。
English
Instrument Storage：Dry, ventilated, clean environment; 15°C–30°C, 10%–80% RH; no corrosive gases or strong EMI.
Tube Storage：2°C–8°C refrigerated, light‑protected, sealed; avoid freezing; use within expiry.
Transport：‑20°C–45°C; avoid severe vibration, rain, direct sunlight; secure instrument during shipping.
Consumables：Store printer paper, fuses at room temp, dry, dust‑free.
十、说明书核心信息｜Manual Core Inｆormation
中文
核心用途：床旁即时检测全血 ACT，监测中高剂量肝素抗凝，适用于心血管手术、介入、透析、ICU 等场景。
操作核心：开机→质控→采血混匀→上机→自动检测→结果输出→清洁维护。
质控要点：每日生物 + 电子质控，三级权限管理，质控锁定，确保结果可靠。
关键参数：两点检测、36.5–37.5℃孵育、0–1500 秒范围、双通道、触控操作、多方式数据输出。
安全合规：CLIA 中度复杂、CE 认证；严格无菌操作，生物安全防护，仪器定期校准维护。
结果解读：ACT 值受多因素影响，需结合临床与其他凝血指标综合判断，不可单独作为诊疗依据。
English
Core Purpose：Point‑of‑care whole blood ACT testing for moderate‑to‑high heparin monitoring in cardiac surgery, intervention, dialysis, ICU, etc..
Operating Flow：Power on → QC → Sample collection/mixing → Testing → Result output → Cleaning/maintenance.
QC Highlights：Daily biological + electronic QC, three user levels, QC lockout for reliability.
Key Specs：Two‑point detection, 36.5–37.5°C incubation, 0–1500s range, dual‑channel, touchscreen, multi‑output.
Compliance & Safety：CLIA Moderate Complexity, CE certified; strict asepsis, biosafety, regular calibration.
Result Interpretation：ACT affected by multiple factors; correlate with clinical and other coagulation tests; not sole diagnostic basis.
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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