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厂商供应海伦娜凝血分析仪Actalyke Mini II
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厂商供应海伦娜凝血分析仪Actalyke Mini II
桂经理19117326863微xin同号
管理类别
第二类
型号规格
Actalyke Mini II
结构及组成/主要组成成分
该产品由显示器、检测室、内置打印机、控制器、角度侦测器、检测管条码器、马达、报警器、加热器、温度侦测器、C-ACT专用规格检测管及随机软件（发布版本号：1.00）组成。
适用范围/预期用途
该产品基于磁珠凝固法原理，与配套的检测试剂共同使用，在临床上用于对来源于人体的全血样本的即时凝血时间进行检测。
一、工作原理｜Working Principle
中文
采用两点磁阻式凝固检测（0° 与 90° 双探测器）+ 恒温孵育原理。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，纤维蛋白形成并包裹磁珠。凝血发生时，磁珠从 0° 探测器向 90° 探测器移动，达到46° 阈值时双探测器协同判定凝固终点，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. An ACT tube containing an internal magnetic bead and activator is loaded with whole blood, placed into the 36.5–37.5°C heating block, and rotated to mix. The activator initiates the intrinsic coagulation pathway; fibrin ｆorms and entraps the magnetic 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 即时检测：全血激活凝血时间（ACT）测定，监测中高剂量肝素抗凝效果。
多试剂兼容：适配硅藻土（C‑ACT）、高岭土（K‑ACT）、玻璃珠（G‑ACT）及混合激活剂（MAX‑ACT）等全系列 ACT 采血管，兼容 Hemochron 系列试管。
恒温控制：36.5–37.5℃孵育，确保凝血反应条件一致。
即时结果输出：内置热敏打印机，检测完成自动打印报告，现场快速获取数据。
自检与报警：开机自动自检，硬件异常时发出声光报警并显示错误代码，保障检测安全。
操作极简：单键启动，无需复杂培训，适用于床旁快速检测场景。
English
Point‑of‑Care ACT Testing: Whole blood Activated Clotting Time (ACT) measurement for accurate monitoring of moderate‑to‑high heparin anticoagulation.
Multi‑Reagent Compatibility: Works with all Actalyke ACT tubes (celite, kaolin, glass‑bead, MAX‑ACT blended activator) and Hemochron tubes for flexible workflow.
Temperature Control: Precise 36.5–37.5°C incubation to ensure consistent clotting reaction conditions.
Immediate Result Output: Built‑in thermal printer for on‑site, real‑time report generation.
Self‑Test & Alarm: Automatic power‑on self‑check; audio/visual alarm and error code display for hardware abnormalities to ensure test safety.
One‑Touch Operation: Simple single‑button start with minimal training, ideal for bedside settings.
三、产品特点｜Product Features
中文
两点检测技术：0°/90° 双探测器协同判定，46° 阈值设计，抗干扰强，结果度与大型 Actalyke 系列设备一致。
单通道紧凑设计：体积小巧（仅 6 英寸 footprint），占地空间小，适合导管室、透析室、手术室等狭小空间。
便携易维护：整机重约 2.4kg（含打印机），可拆卸试管架，日常清洁维护便捷。
宽电压适配：85–265V AC、47–63Hz 全球通用供电，可选配充电电池，支持移动床旁检测。
高可见度显示：3.2×1 英寸高清显示屏，数据清晰易读，便于快速读取结果。
合规可靠：符合 CLIA 非豁免（Non‑waived）要求，质控流程完善，确保检测结果合规可信。
English
Two‑Point Detection Technology: 0°/90° dual detectors with 46° threshold for strong anti‑interference and precise results matching larger Actalyke models.
Single‑Channel Compact Design: Small footprint (6 inches) for minimal space use, perfect for catheterization labs, dialysis units, and operating rooms.
Portable & Easy Maintenance: Only 2.4kg (with printer); removable tube holder for simple daily cleaning and upkeep.
Wide Voltage & Portable Power: 85–265V AC, 47–63Hz global power compatibility; optional rechargeable battery for mobile point‑of‑care testing.
High‑Visibility Display: 3.2×1 inch high‑definition screen for clear, easy‑to‑read results.
Regulatory Compliance: CLIA Non‑waived with comprehensive QC processes to ensure reliable and compliant results.
四、技术参数｜Technical Parameters
中文
表格
参数项 详情
产品型号 Actalyke Mini II（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）
检测原理 两点磁阻式凝固检测（0°/90° 双探测器，46° 阈值判定）
孵育温度 36.5℃–37.5℃（±0.5℃）
检测通道 单通道（1 个检测位）
采血管兼容 Actalyke 系列（C‑ACT/K‑ACT/G‑ACT/MAX‑ACT）、Hemochron 系列 ACT 管
显示屏幕 3.2×1 英寸（8×2.54cm）高清显示屏
整机尺寸 15.5×12.2×16.0cm（宽 × 高 × 深）
整机重量 约 2.4kg（含内置打印机，含电池约 2.4kg）
供电方式 AC 85–265V，47–63Hz；可选配可充电电池（DC）
操作环境 温度 15℃–30℃，相对湿度 10%–80%，无冷凝
数据输出 内置热敏打印机（硬拷贝）
合规认证 CLIA Non‑waived
English
表格
Parameter Details
Model Actalyke Mini II (Helena Laboratories)
Test Item Whole Blood Activated Clotting Time (ACT)
Measurement Range 0–1500 seconds (clinical: 90–1500s)
Detection Principle Two‑point magnetoresistive clot detection (0°/90° dual detectors, 46° threshold)
Incubation Temp 36.5°C–37.5°C (±0.5°C)
Test Channels Single‑channel (1 test well)
Tube Compatibility Actalyke series (C‑ACT/K‑ACT/G‑ACT/MAX‑ACT) & Hemochron ACT tubes
Display 3.2×1 inch (8×2.54cm) high‑definition screen
Dimensions 15.5×12.2×16.0cm (W×H×D)
Weight ~2.4kg (with built‑in printer, with battery ~2.4kg)
Power AC 85–265V, 47–63Hz; optional rechargeable battery (DC)
Operating Environment 15°C–30°C, 10%–80% RH, non‑condensing
Data Output Built‑in thermal printer (hard copy)
Certifications CLIA Non‑waived
五、使用方法｜Instructions for Use
中文
开机自检：连接电源，开机后仪器自动完成自检；若出现硬件错误，仪器会发出三声蜂鸣并显示 “E##”/“####”，排查故障后重试。
质控准备：按规程完成生物质控与电子质控，确认在控后再进行患者检测。
样本处理：静脉采血（枸橼酸钠抗凝），立即颠倒混匀 8–10 次，避免气泡；室温放置不超过 5 分钟。
加样检测：将全血加入 ACT 采血管（按试剂要求加样量），混匀后插入检测槽，关闭舱门；按下 “启动” 按钮，仪器自动旋转、孵育、检测。
结果读取：检测完成后，显示屏显示 ACT 值，同时打印机自动输出报告；记录患者信息、检测时间与结果。
收尾维护：取出采血管，按医疗废物处理；清洁试管架与检测槽，关机或待机。
English
Power‑On Self‑Test: Connect power; instrument perｆorms automatic self‑check. For hardware errors, the unit beeps three times and displays “E##”/“####”; resolve the issue before retrying.
QC Preparation: Complete biological and electronic QC as required; proceed to patient testing only after confirming QC is in control.
Sample Handling: Draw venous blood (sodium citrate anticoagulant), invert 8–10 times immediately to mix, avoid bubbles; store at room temperature for no more than 5 minutes.
Testing: Add whole blood to the ACT tube (per volume instructions), mix, insert into the test well, close the door; press “Start” for automatic rotation, incubation, and detection.
Result Review: Upon completion, the ACT value displays on the screen; the printer automatically generates a report. Record patient inｆormation, test time, and results.
Post‑Test Maintenance: Dispose of the tube as medical waste; clean the tube holder and test well; power off or stand by.
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 complications.
ICU/ED: Coagulation monitoring for critically ill patients on heparin, ECMO support, 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 result deviation; avoid testing.
Do not use expired, contaminated, or inactive activator tubes.
No patient testing if daily QC fails or instrument alarms occur; 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，熟悉仪器 SOP 与质控流程。
样本规范：采血后立即混匀，避免凝血激活；样本室温放置≤5 分钟，不可冷藏 / 冷冻。
试剂管理：ACT 采血管常温保存，检查有效期与完整性，禁止重复使用。
仪器维护：每日清洁试管架与检测槽，定期检查温度与探测器，及时更换打印纸。
质控严格：每日必做生物质控，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、凝血功能影响，需结合临床判断。
安全防护：生物安全操作，防止样本溅洒；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 the instrument SOP and QC processes.
Sample Handling: Mix immediately after draw to prevent clot activation; store at room temperature ≤5 minutes, no refrigeration/freezing.
Reagent Management: Store ACT tubes at room temperature; check expiry and integrity; single‑use only.
Instrument Maintenance: Daily cleaning of the tube holder and test well; periodic temperature/detector checks; replace printer paper as needed.
QC Compliance: Run daily biological QC; stop testing if out‑of‑control, investigate, and document.
Result Interpretation: ACT affected by heparin dose, temperature, hemodilution, and coagulation status; correlate clinically.
Safety: Biosafety precautions to avoid blood exposure; proper grounding to prevent EMI.
Troubleshooting: Refer to the manual or contact the 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；避免阳光直射与剧烈震动。
采血管存储：常温（15℃–30℃）密封保存，避光、防潮；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。
配件存储：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. Avoid direct sunlight and vibration.
Tube Storage: Store at room temperature (15°C–30°C) in a sealed, light‑ and moisture‑proof container; use within expiry; do not use expired tubes.
Transport: -20°C–45°C; avoid severe vibration, rain, and direct sunlight. Secure the instrument during shipping.
Accessory Storage: Store printer paper, fuses, etc., at room temperature, dry and 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：开机自检→质控通过→采血混匀→加样上机→一键启动→自动检测→
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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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