厂商供应STORZ史托斯电磁式冲击波治疗仪21095
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厂商供应STORZ史托斯电磁式冲击波治疗仪21095
桂经理19117326863微xin同号
桂经理19117326863微xin同号
电磁式冲击波治疗仪Chattanooga Intelect F-SW
管理类别
第二类
型号规格
21095
结构及组成/主要组成成分
产品由主机（型号：21095）、F-SW SEPIALT手柄（型号：19000）、聚焦罩（型号：19100、19200）、
透明闭合环（型号：19300）、台车（型号：4560）组成。
适用范围/预期用途
产品在医疗机构使用，用于男性慢性骨盆疼痛综合症（CPPS）的辅助治疗。
1、工作原理 Working Principle
中文：设备采用电磁聚焦式冲击波发生原理，主机高压电容放电至手柄内部线圈，产生瞬时交变磁场，驱动金属膜片振动，通过耦合介质生成聚焦型体外冲击波；冲击波经聚焦罩汇聚，将声能传递至人体靶组织，产生空化效应、机械刺激效应，改善局部微循环、调节疼痛信号传导，实现辅助治疗作用FDA Access...。English：This device adopts electromagnetic focused shock wave generation principle. The high‑voltage capacitor of main unit discharges to the coil inside handpiece to generate transient alternating magnetic field, which drives the vibration of ｍmbedl membrane. Focused extracorporeal shock waves are generated through coupling medium. Shock waves are converged by focusing hood, acoustic energy is delivered to target human tissue to produce cavitation and mechanical stimulation effects, improve local microcirculation and modulate pain signal conduction for adjuvant therapyFDA Access...。
2、功能 Functions
中文
输出聚焦式电磁冲击波，用于临床辅助治疗；
可调节冲击波能量、脉冲频率、总脉冲计数；
触控人机交互界面，参数设置、治疗计数、治疗记录查看；
多规格聚焦罩适配不同治疗深度；
具备过载、异常输出安全保护。
English
Output focused electromagnetic shock wave for clinical adjuvant treatment;
Adjustable shock‑wave energy, pulse frequency and total pulse count;
Touch‑screen HMI for parameter setting, treatment counting and treatment record review;
Multiple focusing hoods for different treatment depths;
Built‑in safety protection against overload and abnormal output.
3、产品特点 Product Features
中文
电磁聚焦式冲击波，能量汇聚于病灶靶点，周围组织损伤风险低；
专科适配男性慢性骨盆疼痛综合征临床治疗场景；
模块化手柄与可更换聚焦罩，适配不同解剖深度；
整机 Ⅱ 类医用电气设备，满足医疗机构安全使用要求；
操作界面简洁，预设临床参考治疗方案；
配套专用台车，方便科室移动摆放。
English
Electromagnetic focused shock wave, energy accurately concentrated on lesion target with low risk of surrounding tissue injury;
Specially adapted for clinical treatment of male chronic pelvic pain syndrome;
Modular handpiece and replaceable focusing hoods for different anatomical depths;
Class II medical electrical equipment complying with safety requirements for medical institutions;
User‑friendly interface with preset clinical reference protocols;
Dedicated trolley for convenient movement and placement in clinical departments.
4、技术参数 Technical Parameters
中文
产品型号：21095（Chattanooga Intelect F‑SW）
冲击波类型：电磁聚焦式体外冲击波
配套手柄：F‑SW SEPIALT（19000）
聚焦罩规格：19100、19200
电源：AC 100‑240V，50/60Hz
防护类别：Ⅰ 类，B 型应用部分
工作环境温度：+10℃～+40℃
相对湿度：30%‑75%，无凝露
大气压力：700hPa‑1060hPa
输出参数：能量、频率、脉冲数可软件设置；
整机组成：主机、治疗手柄、聚焦罩、透明闭合环、移动台车。
English
Model：21095（Chattanooga Intelect F‑SW）
Shock‑wave type：Electromagnetic focused extracorporeal shock wave
Handpiece：F‑SW SEPIALT (19000)
Focusing hood：19100,19200
Power supply：AC 100‑240V,50/60Hz
Protection class：Class I, Type B applied part
Operating ambient temperature：+10℃～+40℃
Relative humidity：30%‑75%, non‑condensing
Atmospheric pressure：700hPa‑1060hPa
Output：Adjustable energy,frequency and pulse count via software
System components：Main unit, therapeutic handpiece, focusing hoods, transparent closure ring, mobile trolley.
5、使用方法 Operation Method
中文
将设备放置于平整稳固台面，连接电源线，装配台车（如需）；
安装 F‑SW SEPIALT 手柄，选择匹配的聚焦罩与透明闭合环，完成机械装配；
开机，进入操作界面，核对设备自检无故障报警；
患者取合适体位，治疗部位皮肤涂抹医用耦合介质；
根据临床医嘱设置治疗能量、脉冲频率、总脉冲数量；
将手柄探头通过耦合介质贴合治疗靶区，启动治疗输出；
治疗过程观察患者反应，完成预设脉冲后设备自动停止；
结束治疗，关机，拆卸手柄配件，清洁消毒配件，做好设备使用记录。
提示：医疗机构内由经过培训的医务人员操作。
English
Place device on flat stable surface, connect power cord, assemble trolley if needed;
Install F‑SW SEPIALT handpiece, select matching focusing hood and transparent closure ring for mechanical assembly;
Power on, enter operation interface, confirm no fault alarm after self‑test;
Place patient in proper posture, apply medical coupling medium on target skin area;
Set treatment energy, pulse frequency and total pulse count according to clinical preｓcription;
Apply handpiece probe onto target area with coupling medium, activate treatment output;
Observe patient response during therapy; device stops automatically after completing preset pulses;
Power off after treatment, disassemble handpiece accessories, clean and disinfect components, record device usage.
Note: Operated only by trained medical staff within medical institutions.
6、适应症 Indications
中文：产品在医疗机构使用，用于男性慢性骨盆疼痛综合症（CPPS）的辅助治疗。English：Intended for adjuvant treatment of male chronic pelvic pain syndrome (CPPS) in medical institutions。
7、禁忌症 Contraindications
中文
治疗区域存在恶性肿瘤；
治疗部位急性感染、皮肤破损、溃疡；
出血性疾病、凝血功能障碍，正在接受抗凝治疗；
妊娠；
靶区邻近重要神经血管、内脏脏器且无安全防护；
植入心脏起搏器等植入式电子器械；
患者无法配合治疗。
English
Malignant tumor at treatment site;
Acute infection, skin breakage or ulcer at target area;
Hemorrhagic disease, coagulation disorder or ongoing anticoagulant therapy;
Pregnancy;
Target area adjacent to critical neurovascular or visceral organs without safe protection;
Implanted electronic devices such as cardiac pacemaker;
Patient cannot cooperate with treatment.
8、注意事项 Notes
中文
仅可在医疗机构内，由受过该设备专项培训的医务人员操作；严格遵照注册证限定适应症使用，不可超范围治疗；
治疗前确认无禁忌症；治疗中密切询问患者感受，出现剧痛、不适应立即停止；
手柄、聚焦罩、闭合环需按说明书要求清洁消毒，避免交叉感染；
必须使用医用耦合介质，禁止干接触输出冲击波；
禁止对眼睛、颅脑、大血管、睾丸等敏感部位输出冲击波；
设备故障报警时，立即停机断电，联系厂家售后，禁止自行拆机维修；
配件使用、更换严格按照说明书周期执行；
儿童、老年患者需谨慎评估后开展治疗。
English
Operated only by specially‑trained medical personnel in medical institutions. Use strictly in accordance with registered indications, off‑label use is prohibited;
Confirm no contraindications before therapy; stop immediately if severe pain or discomfort occurs during treatment;
Clean and disinfect handpiece, focusing hood and closure ring per manual requirement to prevent cross‑infection;
Medical coupling medium must be used; dry‑contact shock‑wave output is forbidden;
Shock‑wave output to eyes, cranium, large blood vessels, testicles and other sensitive parts is prohibited;
In case of fault alarm, shut down and cut off power immediately, contact manufacturer service; disassembly by user is forbidden;
Replace accessories following manual service cycle;
Carefully evaluate pediatric and elderly patients prior to treatment.
9、存储条件 Storage Conditions
中文：环境温度‑10℃～+55℃；相对湿度 20%‑80%，无凝露；大气压力 700‑1060hPa；避免阳光直射、粉尘、腐蚀性气体，远离震动冲击。English：Ambient temperature ‑10℃～+55℃; relative humidity 20%‑80%, non‑condensing; atmospheric pressure 700‑1060hPa. Keep away from direct sunlight, dust, corrosive gas, vibration and impact.
10、说明书核心摘要 Manual Summary
中文：STORZ 21095（Chattanooga Intelect F‑SW）电磁式冲击波治疗仪为 Ⅱ 类进口医疗器械，在医疗机构内由受训医师使用，通过电磁聚焦体外冲击波，对男性慢性骨盆疼痛综合征做辅助治疗。严格遵循适应症、禁忌症，规范使用耦合介质，做好配件消毒；设备不可超适应症使用；故障不得自行拆解，按规定环境存放运输。English：STORZ Model 21095 (Chattanooga Intelect F‑SW) is imported Class II medical device. It shall be used by trained physicians in medical institutions. It delivers electromagnetic focused extracorporeal shock wave for adjuvant treatment of male chronic pelvic pain syndrome. Follow indications and contraindications strictly, use coupling medium properly and disinfect accessories. Off‑indication application is prohibited. Do not disassemble upon failure; store and transport under specified environmental conditions.
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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