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厂商直销史托斯体外冲击波心血管治疗系统MODULITH SLC
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厂商直销史托斯体外冲击波心血管治疗系统MODULITH SLC
桂经理19117326863微xin同号
桂经理19117326863微xin同号
管理类别
第三类
型号规格
MODULITH SLC
结构及组成/主要组成成分
产品由治疗主机（包括冲击波源、治疗臂、控制器、水囊和显示器）组成。
适用范围/预期用途
在医疗机构内使用，用于对冠心病患者进行辅助治疗，减轻患者心绞痛等相关症状。
1、工作原理 Working Principle
中文：设备采用电磁圆筒式冲击波源配合抛物面反射器产生聚焦微能量冲击波；同轴内置超声实时定位心肌缺血靶区，结合心电 ECG 触发，仅在心动周期绝对不应期释放冲击波。低能量冲击波作用于缺血心肌组织，上调一氧化氮 NO、血管内皮生长因子 VEGF 表达，促进心肌微血管再生、建立侧支循环，改善心肌微循环灌注，实现心绞痛辅助治疗效果。English：The system adopts electromagnetic cylindrical shock‑wave source with parabolic reflector to generate focused low‑energy shock‑waves. Built‑in coaxial ultrasound real‑time locates myocardial ischemic target area. Triggered by ECG, shock‑waves are delivered only during absolute refractory period of cardiac cycle. Low‑energy shock‑waves act on ischemic myocardium, up‑regulate NO and VEGF expression, promote myocardial microvascular regeneration and collateral circulation ｆormation, improve myocardial microcirculation perfusion for adjuvant angina pectoris therapyStorz Medi...。
2、产品功能 Functions
中文：1）实时超声同轴定位心肌缺血靶组织；2）ECG 同步触发输出治疗冲击波；3）多档可调冲击波能量、治疗频率；4）治疗臂电动多维调节，对准靶区；5）整机状态监控、治疗参数存储与记录；6）图形触控操作界面，支持 3D 操纵杆定位微调；7）用于冠心病患者心绞痛的辅助治疗Storz Medi...。English：1）Co‑axial real‑time ultrasound localization for myocardial ischemic target；2）ECG‑synchronized triggering for therapeutic shock‑wave output；3）Adjustable shock‑wave energy and treatment frequency；4）Motor‑driven multi‑dimensional therapy arm for precise target alignment；5）System status monitoring, treatment parameter storage and record；6）Graphical touch‑screen UI with 3D joystick fine‑tuning；7）Non‑invasive adjuvant therapy for angina pectoris in coronary heart disease patientsStorz Medi...。
3、产品特点 Product Features
中文：①同轴一体化超声定位，超声与冲击波同轴，肋骨、肺部危险组织可视，定位精度高；②电磁圆筒式冲击波源，能量输出稳定，寿命长；③ECG 心动周期同步触发，规避心肌电活动敏感期，提升治疗安全性；④最大穿透深度 150mm，可覆盖心尖至心肌后壁全部靶区域；⑤治疗臂大范围电动位移，治疗头 360° 旋转适配肋间声窗；⑥低噪音，无需佩戴隔音防护；⑦模块化，可兼容多种诊疗床，触控 + 操纵杆双操作模式；⑧门诊治疗，无需麻醉，患者耐受性好。English：①Integrated co‑axial ultrasound localization; ultrasound and shock‑wave share same axis; ribs and lung risky tissues are visualized for high targeting accuracy；②Electromagnetic cylindrical shock‑wave source with stable energy output and long service life；③ECG cardiac‑cycle synchronized triggering to avoid myocardial electrical sensitive phase for higher safety；④Max penetration depth up to 150 mm, covering targets from cardiac apex to posterior myocardial wall；⑤Wide‑range motor‑driven therapy arm, 360° rotatable therapy head adapting to intercostal acoustic window；⑥Low noise, no ear protection required；⑦Modular design compatible with multiple patient tables, dual control: touch‑screen + joystick；⑧Outpatient non‑invasive therapy without anesthesia, good patient toleranceStorz Medi...。
4、技术参数 Technical Parameters
中文- 冲击波源：电磁圆筒式 - 焦点压力：2.9 MPa～74.0 MPa - 脉冲宽度：≤1 µs - 脉冲上升时间：≤0.5 µs - 治疗频率：1 Hz‑4 Hz 可调 - 焦点尺寸：径向 3.5‑8 mm ×3.5‑8 mm；轴向 90‑110 mm - 焦点定位偏差：径向 ±1.5 mm；轴向 ±3 mm - 治疗臂：水平≥1100 mm；垂直 680‑1080 mm - 治疗头旋转角度：顺时针≥180°；逆时针≥180° - 最大穿透深度：150 mm - 电源：100/115/230 V±10%，50/60 Hz，最大 2.0 kVA - 整机重量：约 240 kgEnglish‑Shock‑wave source: Electromagnetic cylindrical type ‑Focal pressure: 2.9 MPa～74.0 MPa ‑Pulse width: ≤1 µs ‑Pulse rise time: ≤0.5 µs ‑Treatment frequency:1 Hz‑4 Hz adjustable ‑Focal spot size: Radial 3.5‑8 mm ×3.5‑8 mm; Axial 90‑110 mm ‑Focal positioning deviation: Radial ±1.5 mm; Axial ±3 mm ‑Therapy arm: Horizontal stroke ≥1100 mm; Vertical stroke 680‑1080 mm ‑Therapy head rotation: Clockwise ≥180°; Counter‑clockwise ≥180° ‑Max penetration depth:150 mm ‑Power supply:100/115/230 V±10%,50/60 Hz, max 2.0 kVA ‑System weight: approx.240 kg
5、使用方法 Operation Method
中文：1、环境准备：设备放置于合规诊疗室，接通电源，完成系统自检；2、患者准备：患者取仰卧位，连接心电监护，监测血压、血氧；胸部治疗区域涂抹耦合介质；3、靶区定位：移动治疗臂，同轴超声扫查，确定心肌缺血靶区，避开肋骨、肺组织；4、水囊贴合：下调治疗头水囊，使其与胸壁皮肤紧密耦合；5、参数设置：设置冲击波能量、频率、治疗点数，开启 ECG 同步触发；6、实施治疗：逐点输出冲击波，全程监护患者生命体征与主观症状；7、治疗结束：停止输出，归位治疗臂，记录治疗数据；8、术后观察，评估患者状态。仅由经过专项培训医师操作PMC。English：1.Environment preparation: Place unit in qualified clinical room, power‑on and complete self‑test. 2.Patient preparation: Patient lies supine; connect ECG monitoring; monitor blood pressure and SpO₂; apply coupling medium on chest treatment area. 3.Target localization: Move therapy arm, scan with co‑axial ultrasound to identify myocardial ischemic target, avoid ribs and lung tissue. 4.Coupling: Lower therapy head water‑bag to achieve close contact with chest wall. 5.Parameter setup: Set shock‑wave energy, frequency and treatment points, activate ECG synchronized trigger. 6.Treatment delivery: Deliver shock‑waves point‑by‑point, continuously monitor patient vital signs and subjective symptoms. 7.Post‑treatment: Stop output, retract therapy arm, save treatment records. 8.Post‑procedure observation and patient assessment. Only operated by specially‑trained physiciansPMC。
6、适应症 Indications
中文：用于医疗机构内对冠心病患者进行辅助治疗，减轻患者心绞痛相关症状，提高生存质量；适用于难治性心绞痛，不适合冠脉搭桥、PCI 介入手术，药物控制效果不佳，经影像学证实存在心肌缺血的冠心病患者。English：For adjuvant treatment of patients with coronary heart disease in medical institutions, relieve angina pectoris‑related symptoms and improve quality of life. Indicated for refractory angina pectoris patients who are not suitable for CABG or PCI intervention, poor drug‑therapy response, with imaging‑proven myocardial ischemia。
7、禁忌症 Contraindications
中文：①急性心肌梗死、不稳定型心绞痛；②未控制的严重心律失常；③超声肋间声窗差，无法清晰显示靶心肌；④植入未适配本设备的心脏起搏器 / 除颤器；⑤治疗路径存在肺组织、肿瘤、活动性出血；⑥严重凝血功能障碍；⑦妊娠患者；⑧胸壁皮肤破损、感染区域禁止直接耦合治疗头。English：①Acute myocardial infarction, unstable angina pectoris；②Uncontrolled severe arrhythmia；③Poor intercostal acoustic window, target myocardium cannot be clearly visualized；④Implanted pacemaker / defibrillator not compatible with this device；⑤Lung tissue, tumor or active hemorrhage within shock‑wave pathway；⑥Severe coagulation disorders；⑦Pregnant patients；⑧Do not couple therapy head over damaged or infected chest wall skin。
8、注意事项 Precautions
中文：1、医疗机构内，由受过专项培训医师操作；2、治疗全程必须同步心电监护，确保冲击波落在心动周期绝对不应期；3、治疗前超声确认冲击波通路避开肺、肋骨、大血管；4、严格按临床方案设置能量参数，禁止超参数输出；5、治疗中密切观察患者，出现胸痛加重、心悸、呼吸困难立即终止治疗；6、定期校验冲击波焦点定位精度；7、水囊、耦合介质应使用原厂合规耗材；8、不可替代药物、介入、外科手术，仅作为冠心病辅助治疗手段；9、禁止在易燃易爆环境使用；10、设备发生故障应停机报修，不得自行拆解维修。English：1.Only used in medical institutions and operated by specially‑trained physicians. 2.Continuous ECG monitoring is mandatory during treatment to ensure shock‑waves delivered within absolute refractory period. 3.Ultrasound pre‑check must guarantee shock‑wave pathway avoids lung, ribs and great vessels. 4.Set energy strictly according to clinical protocol, over‑parameter output is forbidden. 5.Stop treatment immediately if patient suffers aggravated chest pain, palpitations or dyspnea. 6.Regularly calibrate focal positioning accuracy. 7.Only use original compliant water‑bag and coupling media. 8.This device cannot replace pharmacotherapy, interventional or surgical procedures, only for adjuvant therapy of coronary heart disease. 9.Do not operate in flammable‑explosive atmosphere. 10.Shut‑down for authorized maintenance in case of fault; disassembly by user is prohibited。
9、存储条件 Storage Conditions
中文：环境温度：+10℃～+40℃；相对湿度：30%‑80%，无凝露；大气压力：700‑1060 hPa；存放于干燥通风室内，避免阳光直射、粉尘、腐蚀性气体；长期闲置需断电，水囊做好防护；运输做好减震防护。English：Ambient temperature: +10℃～+40℃; Relative humidity:30%‑80%, non‑condensing; Atmospheric pressure:700‑1060 hPa. Store in dry and ventilated indoor space, avoid direct sunlight, dust and corrosive gas. Power‑off for long‑term storage; protect water‑bag assembly. Shock‑absorbing protection required during transportation。
10、说明书核心摘要 Manual Core Summary
中文：MODULITH SLC 为 Ⅲ 类体外冲击波心血管治疗系统，采用电磁圆筒冲击波源 + 同轴超声定位 + ECG 同步触发技术，门诊模式用于冠心病难治性心绞痛辅助治疗，改善心肌缺血、缓解心绞痛，提升患者生活质量。必须由受过专项培训医师在医疗机构使用；不能替代药物、介入及外科手术；严格遵守适应症、禁忌症与操作流程；定期设备维护校准，使用合规耗材；治疗全程心电监护，严防肺、肋骨等非靶组织损伤。English：MODULITH SLC is Class‑Ⅲ extracorporeal shock‑wave cardiovascular therapy system. It adopts electromagnetic cylindrical shock‑wave source, co‑axial ultrasound localization and ECG‑synchronized triggering technology. It delivers non‑invasive outpatient adjuvant therapy for refractory angina pectoris of coronary heart disease, improves myocardial ischemia, relieves angina symptoms and enhances patient quality of life. It shall be operated only by specially‑trained physicians within medical institutions. It cannot replace medication, interventional or surgical treatment. Strictly comply with indications, contraindications and operating procedures. Perｆorm regular maintenance and calibration, use compliant consumables. Continuous ECG monitoring is required during treatment to prevent injury to non‑target tissues such as lung and ribs.
免责声明：以上产品详情仅供参考，临床操作请以原厂纸质说明书为准。上海康世达医疗器械有限公司不生产医疗产品，所有产品均来自产品的生产厂家，代理商，经销商，如有侵权请联系我们，会尽快处理！The above product details are for reference only. All clinical operations shall be carried out in strict accordance with the original paper instructions for use issued by the manufacturer.
Shanghai Kangshida Medical Devices Co., Ltd. does not manufacture medical devices. All products are sourced from respective manufacturers, authorized agents and distributors.
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