厂商直销海伦娜血小板聚集分析系统AggRAM
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厂商直销海伦娜血小板聚集分析系统AggRAM
桂经理19117326863微xin同号
管理类别
第二类
型号规格
AggRAM
结构及组成/主要组成成分
分析仪由主机（加热模块和光路系统）组成。
适用范围/预期用途
该产品主要用于实验室对血小板聚集功能和瑞斯托菌素辅助因子的检测。
一、工作原理｜Working Principle
中文
采用光比浊法（LTA，Born 法），为血小板功能检测准。以650nm 激光为光源，4 通道同步检测。
样本制备：静脉血抗凝后低速离心，分离富血小板血浆（PRP）与贫血小板血浆（PPP），PPP 设为透光基线。
孵育与搅拌：PRP 置入 37℃±1℃恒温反应槽，加入诱导剂（ADP、胶原、花生四烯酸、肾上腺素、瑞斯托霉素等）并持续搅拌。
光学检测：血小板未聚集时 PRP 浑浊、透光率低；聚集形成团块后血浆变清、透光率升高。仪器实时监测透光率变化，转化为聚集曲线。
结果计算：自动计算最大聚集率、聚集斜率、达峰时间、滞后相、曲线下面积等参数，评估血小板聚集功能。
English
Adopts light transmission aggregometry (LTA, Born method), the gold standard for platelet function testing. Uses 650nm laser as light source with 4‑channel simultaneous detection.
Sample Preparation: Anticoagulated venous blood is centrifuged at low speed to separate platelet‑rich plasma (PRP) and platelet‑poor plasma (PPP), with PPP as the light transmission baseline.
Incubation & Stirring: PRP is placed in a 37°C±1°C constant‑temperature reaction chamber; agonists (ADP, collagen, arachidonic acid, epinephrine, ristocetin, etc.) are added with continuous stirring.
Optical Detection: Unaggregated PRP is turbid with low light transmittance; as platelets aggregate into clumps, plasma clarifies and transmittance increases. The analyzer monitors transmittance changes in real time and generates aggregation curves.
Result Calculation: Automatically computes max aggregation %, aggregation slope, time to peak, lag phase, area under curve (AUC) to evaluate platelet aggregation function.
二、产品功能｜Product Functions
中文
血小板聚集检测：支持 ADP、胶原、花生四烯酸、肾上腺素、瑞斯托霉素等多诱导剂检测，评估内 / 外源性聚集功能。
瑞斯托霉素辅因子（Ristocetin Cofactor）检测：诊断血管性血友病（vWD）等遗传性血小板功能障碍。
多通道并行：4/8 通道同步检测，单次可测 4–8 份样本，效率高。
微量样本：最小反应体积 250µL，节省样本与试剂。
自动数据处理：自动计算聚集参数、平滑曲线、生成报告；支持 21 份结果叠加对比。
质控管理：Levey‑Jennings 质控图、Westgard 规则判断、 corrective action log，符合 CLSI 标准。
数据互通：内置数据库、自动备份；支持 LIS 单向传输、PC / 打印机输出。
自定义设置：可编辑检测序列、浓度、体积、孵育时间、显示参数，适配不同临床需求。
English
Platelet Aggregation Testing: Supports multiple agonists (ADP, collagen, arachidonic acid, epinephrine, ristocetin) to evaluate intrinsic/extrinsic aggregation function.
Ristocetin Cofactor Assay: Diagnoses hereditary platelet disorders like von Willebrand disease (vWD).
Multi‑Channel Parallel: 4/8 channels for simultaneous testing; 4–8 samples per run for high efficiency.
Micro‑Volume: Minimum 250µL reaction volume, conserving samples and reagents.
Automatic Data Processing: Computes aggregation parameters, smooths curves, generates reports; overlays up to 21 results for comparison.
QC Management: Levey‑Jennings charts, Westgard rule evaluation, corrective action log; CLSI‑compliant.
Data Connectivity: Built‑in database with auto‑backup; LIS uni‑directional interface, PC/printer output.
Customization: Editable test sequences, concentrations, volumes, incubation times, and display parameters for clinical flexibility.
三、产品特点｜Product Features
中文
准技术：光比浊法（LTA），结果权威、临床认可度高。
激光光学系统：650nm 激光 + 4 通道检测，灵敏度高、稳定性好、抗干扰强。
灵活配置：4/8 通道可选，支持半体积模式，搅拌速度可编程。
操作便捷：Windows 界面、触控 / 键鼠操作，自动启动、判读、报告，无需复杂培训。
温控：37℃±1℃恒温孵育，保证反应条件一致。
数据强大：自动计算全参数、曲线叠加、质控追溯、多级权限管理。
合规可靠：符合 CLSI H58‑A、CE、FDA 510 (k)，适用于临床诊断与科研。
模块化设计：分析仪模块 + 电脑 / 软件分离，便于维护与升级。
English
Gold Standard Technology: Light transmission aggregometry (LTA) with authoritative, widely accepted results.
Laser Optics: 650nm laser + 4‑channel detection for high sensitivity, stability, and anti‑interference.
Flexible Configuration: 4/8 channels, half‑volume mode, programmable stirring speed.
User‑Friendly: Windows interface, touch/keyboard‑mouse control; auto‑start, interpretation, and reporting with minimal training.
Precise Temperature Control: 37°C±1°C incubation for consistent reaction conditions.
Powerful Data Tools: Automatic full‑parameter calculation, curve overlay, QC traceability, multi‑level access control.
Regulatory Compliance: CLSI H58‑A, CE, FDA 510(k) cleared for clinical and research use.
Modular Design: Separate analyzer module + computer/software for easy maintenance and upgrades.
四、技术参数｜Technical Parameters
中文
表格
参数项 详情
产品型号 AggRAM（Helena Laboratories）
检测原理 光比浊法（LTA），650nm 激光光学检测
检测通道 4 通道 / 模块，可扩展至 8 通道
检测项目 血小板聚集、瑞斯托霉素辅因子（Ristocetin Cofactor）
诱导剂类型 ADP、胶原、花生四烯酸、肾上腺素、瑞斯托霉素等
反应体积 标准 500µL，微量 250µL（半体积模式）
孵育温度 37℃±1℃
搅拌速度 可编程（适配半体积 / 标准体积）
测量范围 透光率：-20%～110%（±0.5%）；吸光度：0.0～2.0 OD
比色杯 8mm×60mm，硅涂层玻璃
搅拌子 3.5mm×4mm，涂层磁珠
数据处理 自动计算斜率、最大聚集率、达峰时间、滞后相、AUC（科研）
供电 110/220V AC，50/60Hz，最大 30W
尺寸 15.24cm（高）×25.40cm（宽）×43.18cm（深）
重量 <6.75kg
操作环境 温度 15℃～30℃，湿度 10%～80%，无冷凝
合规认证 CLSI H58‑A、CE、FDA 510(k)（K050053）
English
表格
Parameter Details
Model AggRAM (Helena Laboratories)
Detection Principle Light transmission aggregometry (LTA), 650nm laser optics
Channels 4 channels/module, expandable to 8 channels
Test Items Platelet aggregation, Ristocetin Cofactor assay
Agonists ADP, collagen, arachidonic acid, epinephrine, ristocetin, etc.
Reaction Volume Standard 500µL, micro 250µL (half‑volume mode)
Incubation Temp 37°C±1°C
Stir Speed Programmable (half/standard volume optimized)
Measurement Range Transmittance: -20%–110% (±0.5%); Absorbance: 0.0–2.0 OD
Cuvette 8mm×60mm, silicone‑coated glass
Stir Bar 3.5mm×4mm, coated magnetic bead
Data Analysis Auto‑calculates slope, max aggregation %, time to peak, lag phase, AUC (research)
Power 110/220V AC, 50/60Hz, max 30W
Dimensions 15.24cm (H) ×25.40cm (W) ×43.18cm (D)
Weight <6.75kg
Operating Environment 15°C–30°C, 10%–80% RH, non‑condensing
Certifications CLSI H58‑A, CE, FDA 510(k) (K050053)
五、使用方法｜Instructions for Use
中文
开机准备：连接电源，启动分析仪与电脑软件；自检通过后，设置日期、操作员、质控规则。
质控检测：每日运行生物质控，Levey‑Jennings 图判断在控；失控需排查原因并记录。
样本制备：静脉采血（枸橼酸钠抗凝 1:9），150g 离心 10 分钟，分离 PRP 与 PPP；PRP 血小板计数（150–450×10⁹/L），室温放置≤2 小时。
试剂准备：复溶诱导剂（ADP、胶原等），按说明书稀释；37℃预温试剂与比色杯。
上机检测：
基线校准：PPP 加入比色杯，设置透光率 100% 基线。
样本检测：PRP + 诱导剂加入比色杯，置入反应槽，启动检测；自动搅拌、孵育、记录曲线。
结果分析：软件自动计算参数，生成报告；审核曲线形态与数值，保存 / 打印 / 传输至 LIS。
术后维护：取出比色杯，清洁反应槽与光学部件；关机，整理耗材与样本。
English
Startup: Connect power, turn on analyzer and software; after self‑test, set date, operator, and QC rules.
QC Testing: Run biological QC daily; verify in‑control via Levey‑Jennings charts; investigate and document if out‑of‑control.
Sample Prep: Venous blood (citrate anticoagulant 1:9), centrifuge at 150g for 10min to separate PRP and PPP; adjust PRP platelet count (150–450×10⁹/L), store at room temp ≤2h.
Reagent Prep: Reconstitute agonists (ADP, collagen, etc.) and dilute per instructions; pre‑warm reagents and cuvettes to 37°C.
Testing:
Baseline Calibration: Add PPP to cuvette, set 100% transmittance baseline.
Sample Test: Add PRP + agonist to cuvette, place in chamber, start test; auto‑stir, incubate, and record curves.
Result Analysis: Software auto‑calculates parameters and generates reports; review curves and values, save/print/transfer to LIS.
Maintenance: Remove cuvettes, clean chamber and optics; power off, organize consumables and samples.
六、适应症｜Indications
中文
出血性疾病诊断：血小板无力症、巨大血小板综合征、血管性血友病（vWD）等遗传性 / 获得性血小板功能缺陷筛查。
血栓风险评估：心梗、脑梗、外周血管病、深静脉血栓等血栓性疾病的血小板高反应性检测。
抗血小板药物监测：阿司匹林、氯吡格雷、替格瑞洛等药效评估，指导个体化用药（如氯吡格雷低反应调整）。
术前凝血评估：外科 / 介入手术前血小板功能检测，预警术中出血风险。
科研应用：血小板药理学、抗血小板药物筛选、活血化瘀中药机理研究。
English
Bleeding Disorder Diagnosis: Screen for hereditary/acquired platelet function defects (e.g., Glanzmann thrombasthenia, Bernard‑Soulier syndrome, von Willebrand disease).
Thrombosis Risk Assessment: Detect platelet hyper‑reactivity in myocardial infarction, stroke, peripheral vascular disease, DVT.
Antiplatelet Drug Monitoring: Evaluate efficacy of aspirin, clopidogrel, ticagrelor; guide personalized therapy (e.g., clopidogrel hypo‑response adjustment).
Preoperative Coagulation Evaluation: Assess platelet function before surgery/intervention to predict bleeding risk.
Research Applications: Platelet pharmacology, antiplatelet drug screening, traditional Chinese medicine (blood‑activating/stasis‑resolving) mechanism studies.
七、禁忌症｜Contraindications
中文
样本质量不合格：严重溶血、脂血、黄疸样本，结果不可靠，禁止检测。
抗凝 / 药物干扰：样本采集前 48 小时内服用阿司匹林、氯吡格雷、非甾体抗炎药等，未停药者结果仅供参考。
血小板计数异常：PRP 血小板计数＜100×10⁹/L 或＞500×10⁹/L，影响聚集结果，需校正后检测。
仪器未质控 / 故障：每日质控未通过、仪器报警或光学系统异常，严禁检测患者样本。
试剂过期 / 污染：诱导剂过期、复溶不当、污染，禁止使用。
English
Poor Sample Quality: Severe hemolysis, lipemia, or icterus produce unreliable results; do not test.
Drug Interference: Aspirin, clopidogrel, NSAIDs taken within 48h before sampling; results are for reference only if not discontinued.
Abnormal Platelet Count: PRP platelet count <100×10⁹/L or >500×10⁹/L affects results; correct before testing.
Failed QC/Malfunction: No patient testing if daily QC fails, instrument alarms, or optics are abnormal.
Expired/Contaminated Reagents: Do not use expired, improperly reconstituted, or contaminated agonists.
八、注意事项｜Precautions
中文
人员资质：经培训的检验 / 临床人员操作，熟悉 CLSI 标准与仪器 SOP。
样本规范：采血后 1 小时内分离 PRP，室温放置≤2 小时，避免冷藏 / 冷冻；轻柔操作，防止血小板激活。
试剂管理：诱导剂 2–8℃冷藏，复溶后尽快使用；避免反复冻融，记录开瓶日期。
仪器维护：每日清洁反应槽与光学窗口，定期校准激光与温度；及时更换比色杯与搅拌子。
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；遵循 Westgard 规则。
结果解读：聚集结果受血小板计数、温度、药物、抗凝剂影响，需结合临床与其他凝血指标综合判断。
安全操作：生物安全防护，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 / 异常曲线，查阅手册或联系厂家，禁止自行拆卸维修。
English
Operator Qualification: For trained lab/clinical personnel only; familiar with CLSI standards and instrument SOP.
Sample Handling: Separate PRP within 1h of draw; store at room temp ≤2h, no refrigeration/freezing; gentle manipulation to prevent platelet activation.
Reagent Management: Store agonists at 2–8°C; use promptly after reconstitution; avoid freeze‑thaw cycles; log opening date.
Instrument Maintenance: Daily cleaning of chamber and optics; periodic laser/temperature calibration; replace cuvettes and stir bars as needed.
QC Compliance: Run daily biological QC; stop testing if out‑of‑control, investigate and document; follow Westgard rules.
Result Interpretation: Aggregation affected by platelet count, temperature, drugs, anticoagulants; correlate with clinical and other coagulation tests.
Safety: Biosafety precautions to avoid blood exposure; proper grounding to prevent EMI.
Troubleshooting: Refer to manual or contact manufacturer for alarms/abnormal curves; 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℃，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。
试剂存储：诱导剂干粉 2–8℃冷藏，避光密封；复溶后 2–8℃保存，有效期按说明书；严禁冻结。
样本存储：PRP 室温（18–25℃）放置≤2 小时，不可冷藏 / 冷冻；PPP 可 2–8℃短期保存。
耗材存储：比色杯、搅拌子常温干燥保存，防潮防尘；一次性使用，禁止重复。
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。
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.
Reagent Storage: Lyophilized agonists at 2–8°C, light‑protected and sealed; reconstituted reagents at 2–8°C per expiry; do not freeze.
Sample Storage: PRP at room temp (18–25°C) ≤2h; no refrigeration/freezing; PPP may be stored short‑term at 2–8°C.
Consumables Storage: Cuvettes and stir bars at room temp, dry, dust‑free; single‑use only.
Transport: -20°C–45°C; avoid severe vibration, rain, direct sunlight; secure instrument during shipping.
十、说明书核心信息｜Manual Core Inｆormation
中文
核心用途：基于光比浊法（LTA）的半自动化血小板聚集与瑞斯托霉素辅因子检测，为临床血小板功能评估准工具。
操作流程：开机→质控→样本制备→试剂预温→基线校准→样本检测→结果分析→清洁维护。
质控要点：每日生物质控，Levey‑Jennings 图 + Westgard 规则，失控即停，全程可追溯。
关键参数：650nm 激光、4/8 通道、37℃±1℃、250/500µL 体积、多诱导剂兼容、自动参数计算。
合规声明：CLSI H58‑A、CE、FDA 510 (k) 认证，适用于临床诊断与科研；持证人员操作。
结果解读：聚集率、斜率、达峰时间为核心指标；受药物、血小板计数、温度影响，需结合临床综合判断。
English
Core Purpose: Semi‑automated platelet aggregation and Ristocetin Cofactor testing via light transmission aggregometry (LTA), the gold standard for clinical platelet function assessment.
Workflow: Power on → QC → Sample prep → Reagent pre‑warm → Baseline calibration → Sample test → Result analysis → Cleaning/maintenance.
QC Highlights: Daily biological QC, Levey‑Jennings charts + Westgard rules, stop on out‑of‑control, full traceability.
Key Specs: 650nm laser, 4/8 channels, 37°C±1°C, 250/500µL volume, multi‑agonist compatibility, auto‑parameter calculation.
Compliance: CLSI H58‑A, CE, FDA 510(k) cleared for clinical and research use; for licensed personnel only.
Result Interpretation: Max aggregation %, slope, time to peak are core metrics; affected by drugs, platelet count, temperature; correlate with clinical status.
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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