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厂家供应史托斯体外冲击波治疗仪MASTERPULS MP 200
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厂家供应史托斯体外冲击波治疗仪MASTERPULS MP 200
桂经理19117326863微xin同号
桂经理19117326863微xin同号
管理类别
第二类
型号规格
MASTERPULS MP 200
结构及组成/主要组成成分
由主机，治疗探头(R15, A6, C15, DI 15, F15, D20-S, D35-S, V25, V40)，控制手柄和空气压缩机(ENERGYII)组成。
适用范围/预期用途
该产品适用于生物力学疗法, 肌筋膜激痛点,疗法， 和针灸冲击波疗法，缓解肌腱止点功能障碍,活化肌肉和结缔组织。
在医疗机构内使用。
1、工作原理 Working Principle
中文：设备为气动弹道式发散式体外冲击波系统，内置静音空气压缩机驱动手柄内部抛射体高速运动，撞击治疗探头产生径向压力冲击波；集成 VACU‑ACTOR 真空负压技术、V‑ACTOR 振动技术，冲击波能量穿透人体软组织，产生机械应力、空化效应，改善局部微循环、促进组织修复、松解粘连、缓解疼痛，实现骨科康复理疗作用ManualsLib。English：It is a pneumatic ballistic radial extracorporeal shock wave system. The built‑in silent air compressor drives the projectile inside the handpiece to move at high speed, hitting the applicator to generate radial pressure shock‑waves. Integrated with VACU‑ACTOR vacuum negative‑pressure technology and V‑ACTOR vibration technology. Shock‑wave energy penetrates soft human tissues, producing mechanical stress and cavitation effects to improve local microcirculation, promote tissue repair, release adhesion and relieve pain for orthopedic rehabilitation and physical therapyManualsLib。
2、功能 Functions
中文：①径向发散式冲击波治疗；②VACU‑ACTOR 真空负压理疗；③V‑ACTOR 振动刺激治疗；④Skin Touch 触控触发输出；⑤多探头适配，可完成肌腱、筋膜、激痛点生物力学理疗；⑥内置预设治疗方案，可自定义存储治疗参数；⑦手柄端直接调节压力、频率、脉冲计数。English：①Radial divergent shock‑wave therapy; ②VACU‑ACTOR vacuum negative‑pressure therapy; ③V‑ACTOR vibration stimulation therapy; ④Skin Touch trigger output; ⑤Multi‑applicator compatibility for biomechanical therapy on tendons, fascia and trigger points; ⑥Built‑in preset treatment protocols, support custom saving of parameters; ⑦Pressure, frequency and pulse count adjustable directly on handpiece。
3、产品特点 Product Features
中文：①三技术合一：冲击波 + 负压 + 振动三重治疗模式；②FALCON 人体工学手柄，带 Active‑tip‑control 手柄显示；③内置静音 Air‑Power 压缩机，无需外接气源；④Skin Touch 皮肤接触触发输出；⑤多种规格治疗探头可选，适配不同治疗深度；⑥30 套以上预设临床方案，支持自定义方案；⑦可选 10 英寸触控显示屏；⑧能量输出稳定，脉冲计数；⑨二类医疗器械，医疗机构使用。English：①Triple‑technology integration: shock‑wave + vacuum + vibration therapy; ②Ergonomic FALCON handpiece with Active‑tip‑control display; ③Built‑in silent Air‑Power compressor, no external air source required; ④Skin‑Touch contact trigger; ⑤Multiple applicators for different penetration depths; ⑥More than 30 preset clinical protocols, user‑customizable; ⑦Optional 10‑inch touch‑screen; ⑧Stable energy output, accurate pulse counting; ⑨Class II medical device for medical institution use。
4、技术参数 Technical Parameters
中文
整机尺寸（不含触屏）：466 × 187 × 454 mm（宽 × 高 × 深）
整机重量：23 kg
供电：100‑240 VAC，50/60 Hz
冲击波压力：0.3‑5 bar (eff)，步长 0.1 bar
冲击波频率：1‑21 Hz
V‑ACTOR 振动频率：1‑50 Hz
最大能量流密度：0.63 mJ/mm²
负压最大：‑500 mbar
工作模式：单脉冲、连续脉冲、振动模式、真空辅助模式
探头配置：R15、A6、C15、DI15、F15、D20‑S、D35‑S、V25、V40 等
防护等级：I 类，B 型应用部分，符合 IEC60601‑1
English
Dimensions (w/o touch screen): 466 × 187 × 454 mm(W×H×D)
Weight: 23 kg
Power supply:100‑240 VAC,50/60 Hz
Shock‑wave pressure:0.3‑5 bar(eff),0.1 bar step
Shock‑wave frequency:1‑21 Hz
V‑ACTOR vibration frequency:1‑50 Hz
Max energy flux density:0.63 mJ/mm²
Max vacuum:‑500 mbar
Operating modes: single pulse, continuous pulse, vibration mode, vacuum‑assisted mode
Applicators: R15, A6, C15, DI15, F15, D20‑S, D35‑S, V25, V40 etc.
Protection class: Class I, Type‑B applied part, compliant with IEC60601‑1
5、使用方法 Operation Method
中文
将主机放置平稳，接通电源，开机自检；
根据治疗部位选择适配治疗探头，安装至手柄；
调取内置方案或手动设置压力、频率、总脉冲数；
治疗部位涂抹耦合介质，探头贴合皮肤，Skin‑Touch 触发输出；
按临床规范移动探头完成病灶区域治疗；
治疗结束停止输出，关机，拆卸探头，探头、手柄按规范消毒；
常规疗程：3‑5 次为一疗程，两次治疗间隔 2‑3 天，严格遵循临床医嘱。
English
Place main unit stably, connect power and perｆorm power‑on self‑test.
Select proper applicator for target area and mount onto handpiece.
Recall preset protocol or manually set pressure, frequency and total pulse count.
Apply coupling medium to treatment area, attach applicator to skin, activate output via Skin‑Touch.
Move applicator following clinical guidelines to treat lesion area.
Stop output after treatment, power‑off, remove applicator, disinfect applicator and handpiece per specification.
General treatment course: 3‑5 sessions per course, interval 2‑3 days between sessions, strictly follow clinical physician’s orders。
6、适应症 Indications
中文：适用于医疗机构内生物力学疗法、肌筋膜激痛点疗法、针灸冲击波疗法；缓解肌腱止点功能障碍，活化肌肉与结缔组织；用于钙化性肌腱炎、肱骨内外上髁炎、足底筋膜炎、跟腱病变、髌骨肌腱病、肌筋膜疼痛、运动软组织损伤等肌肉骨骼慢性疼痛的辅助理疗。English：For biomechanical therapy, myofascial trigger‑point therapy and acupuncture shock‑wave therapy in medical institutions; relieve enthesis dysfunction, activate muscle and connective tissue; adjuvant physical therapy for chronic musculoskeletal pain including calcifying tendinitis, medial‑lateral epicondylitis, plantar fasciitis, achillopathy, patellar tendinopathy, myofascial pain and sports soft‑tissue injuries。
7、禁忌症 Contraindications
中文
治疗区域恶性肿瘤；
凝血功能障碍、血友病，正在服用抗凝药物患者；
妊娠；
儿童骨骺生长板区域；
目标部位急性血栓、大血管、神经干直接照射；
治疗区域皮肤破损、感染；
植入起搏器、植入式电子器械部位；
眼睛、头脑部禁止治疗ManualsLib。
English
Malignant tumor within treatment area.
Coagulation disorders, hemophilia, patients under anticoagulant medication.
Pregnancy.
Epiphyseal growth plates in children.
Direct irradiation over acute thrombosis, large blood vessels and major nerve trunks.
Damaged or infected skin at target site.
Sites with pacemaker or implanted electronic devices.
Eyes and cranial region must not be treatedManualsLib。
8、注意事项 Precautions
中文
医疗机构内，由经过培训的专业人员操作；
治疗时操作人员与患者佩戴防护护目镜；
严格避开禁忌症部位，不可超参数输出；
治疗部位必须使用耦合介质，严禁干打；
治疗中询问患者痛感，及时调整能量；
治疗后局部轻微酸胀属于常见反应，若持续剧痛、肿胀需复诊；
探头属于损耗件，定期检查磨损，损坏立即更换；
不可用于说明书未批准的超适应症用途；
设备接地可靠，避免电磁干扰；
维修保养必须由厂家授权人员执行。
English
Operated only by trained professionals inside medical institutions.
Both operator and patient shall wear protective goggles during treatment.
Strictly avoid contraindicated areas, do not exceed rated output parameters.
Coupling medium must be applied; dry‑shot operation is prohibited.
Inquire patient about pain sensation during therapy and adjust energy timely.
Mild local soreness after treatment is common; seek medical consultation for persistent severe pain or swelling.
Applicators are consumable parts; inspect wear regularly and replace damaged ones immediately.
Do not use for off‑label indications not approved in IFU.
Reliable equipment grounding, avoid electromagnetic interference.
Maintenance and repair must be perｆormed by manufacturer‑authorized personnel.
9、存储条件 Storage Conditions
中文：环境温度‑10℃～+55℃；相对湿度 10%‑80% 无冷凝；大气压力 700‑1060hPa；存放于干燥通风无尘室内，避免阳光直射、雨水淋溅，远离腐蚀性气体。运输避免剧烈撞击。English：Ambient temperature:‑10℃～+55℃; relative humidity 10%‑80% non‑condensing; atmospheric pressure 700‑1060 hPa. Store in dry, ventilated and dust‑free room, avoid direct sunlight, rain splash and corrosive gas. Avoid violent impact during transportation.
10、说明书核心摘要 Core Summary of Instructions
中文：STORZ MASTERPULS MP200 为瑞士史托斯生产的二类发散式体外冲击波治疗仪，集成冲击波、负压、振动三重理疗技术，用于医疗机构肌肉骨骼系统慢性疼痛辅助康复。禁止肿瘤、凝血障碍、骨骺区、眼部等部位治疗；必须由持证受训人员操作，使用耦合介质，佩戴护目镜；探头为消耗件，定期维护；遵循规定疗程间隔；存储注意温湿度；维修需厂家授权人员执行。English：STORZ MASTERPULS MP200 is Class II radial extracorporeal shock‑wave therapeutic device manufactured by Storz Medical AG(Switzerland), integrating shock‑wave, vacuum and vibration triple therapy for adjuvant rehabilitation of chronic musculoskeletal pain in medical institutions. Treatment over tumor, coagulation‑disorder patients, epiphyseal plates, eyes and other forbidden sites is prohibited. Operation shall be perｆormed by licensed trained personnel; coupling medium and protective goggles are mandatory. Applicators are consumables requiring regular maintenance. Follow specified session intervals. Observe temperature‑humidity storage requirements. Repair shall be done by manufacturer‑authorized personnel.
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.
Please contact us promptly in case of any infringement, and we will resolve the matter as soon as possible.
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