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厂家直供英智经颅磁刺激仪Smart-R10
桂经理19117326863微xin同号
桂经理19117326863微xin同号
产品名称 经颅磁刺激仪
管理类别 第二类
型号规格 Smart-R10、Smart-R20、Smart-R50、Smart-N5、Smart-N10
结构及组成/主要组成成分 由刺激发生器、刺激线圈、MEP 模块（选配）、扩展推车（选配）、定位帽（选配）、支架（选配）组成。
适用范围/预期用途 用于人体中枢神经和外周神经功能的检测、评定及辅助治疗。
一、工作原理 Working Principle
中文
设备刺激发生器输出瞬时强交变电流至专用刺激线圈，依据法拉第电磁感应定律产生高速变化的脉冲磁场。磁场无衰减穿透衣物、头皮、颅骨、外周软组织直达中枢皮层或外周神经靶点；时变磁场在人体神经导电组织内感应内生微电流，改变神经元细胞膜电位、引发去极化，调控神经细胞兴奋性与突触可塑性。
中枢脑区调控：高频（＞5Hz）脉冲提升皮层神经元兴奋性；低频（≤1Hz）抑制过度兴奋；支持 TBSθ 爆发、成对脉冲模式，重塑脑网络平衡，改善情绪、认知、运动功能。
外周神经修复：脉冲磁场刺激四肢外周运动 / 感觉神经，诱发节律性肌肉收缩，改善局部微循环，缓解痉挛麻木，加速受损神经轴突修复。
MEP 神经评定机制（选配）：无线双通道 MEP 模块捕捉刺激诱发的肌肉电信号，自动测算静息运动阈值 RMT，量化中枢、外周神经传导损伤程度，客观评估康复疗效。
定位靶向机制：配套 10-20 系统定位帽，快速锁定标准脑功能靶点，保证磁场能量稳定作用于病灶区域，降低脱靶概率。
English
The stimulator outputs instantaneous strong alternating current to dedicated stimulation coils, generating rapidly changing pulsed magnetic field based on Faraday’s Law of Electromagnetic Induction. The magnetic field penetrates clothing, scalp, skull and peripheral soft tissues without attenuation, directly targeting cerebral cortex or peripheral nerves. The time-varying magnetic field induces endogenous micro-current inside human conductive nerve tissues, alters neuronal membrane potential and triggers depolarization to precisely regulate neuronal excitability and synaptic plasticityPMC.
Central Brain Modulation: High-frequency pulses (＞5Hz) enhance cortical neuronal excitability; low-frequency pulses (≤1Hz) suppress excessive excitation. It supports TBS theta burst and paired pulse modes to reshape balanced brain networks and improve mood, cognition and motor functions.
Peripheral Nerve Repair: Pulsed magnetic field stimulates peripheral motor/sensory nerves of limbs to induce rhythmic muscle contraction, boost local microcirculation, relieve spasm and numbness, and accelerate repair of damaged nerve axons.
MEP Nerve Assessment Mechanism (Optional): The wireless dual-channel MEP module captures muscle electrical signals induced by stimulation, automatically calculates resting motor threshold (RMT), quantifies the damage degree of central and peripheral nerve conduction, and ｏbjectively evaluates rehabilitation efficacy.
Target Positioning Mechanism: Matched positioning cap based on international 10-20 EEG system quickly locks standard brain functional targets, ensuring stable magnetic energy acting on lesion areas and reducing target offset risk.
二、产品功能 Product Functions
中文
全模式脉冲输出：支持单脉冲、重复 rTMS、TBSθ 爆发、成对脉冲 4 类核心刺激模式；频率 0.01–100Hz 连续可调，低频段最小步进 0.1Hz，适配精神、神经康复全临床方案。
标准化 10-20 脑定位系统：标配定位帽，快速完成 DLPFC 运动皮层、Broca 语言区等标准靶点定位，无需复杂 3D 影像，基层门诊快速落地使用。
选配无线 MEP 运动诱发电位检测：双通道无线采集肌肉诱发电位，AI 自动识别波形、测算运动阈值，量化神经损伤，用于方案个体化校准与疗效随访对比。
内置循证专家处方库：预装抑郁症、强迫症、脑卒中、帕金森、失眠、肢体痉挛等标准化治疗方案，一键调用自动运行；支持医护自定义存储个性化参数方案。
高清触控交互终端：一体化触控显示屏，参数可视化设置，实时显示刺激强度、频率、剩余治疗时长、总脉冲数，操作逻辑简单易上手。
数字化病例档案管理：自动存储患者基础信息、靶点定位记录、历次运动阈值、全部治疗参数与疗效记录；支持病例检索、数据导出、标准化疗效报告打印。
线圈恒温散热保护：刺激线圈内置循环散热结构，长时间连续治疗温升可控；线圈温度超安全阈值自动停机并声光报警，杜绝高温烫伤。
模块化多线圈快速更换：标配 8 字聚焦线圈；可选圆形线圈、外周神经专用线圈；线圈支持快速插拔更换，单人医护即可完成操作。
多维度安全实时监测：集成线圈脱落、过流、过压、超温、磁场过载、癫痫预警实时监测；刺激强度平缓淡入淡出，无突发强磁场冲击；异常即刻切断输出并声光报警。
静音可移动推车整机：整机搭配静音万向脚轮，支架多维度升降、旋转、平移调节，适配不同身高、头型、年龄患者，诊室灵活摆放转运。
English
Full-Mode Pulse Output System: Supports four core stimulation modes: single pulse, repetitive rTMS, TBS theta burst, paired pulse. Frequency is continuously adjustable from 0.01–100Hz with minimum step 0.1Hz for low-frequency range, compatible with all clinical protocols for psychiatry and neurological rehabilitation.
Standardized 10-20 Brain Positioning System: Standard equipped positioning cap quickly completes target positioning for DLPFC motor cortex, Broca language area and other standard targets, without complex 3D imaging, easy to deploy in primary clinics.
Optional Wireless MEP Motor Evoked Potential Detection: Dual-channel wireless collection of muscle evoked potentials; AI automatically identifies waveｆorms and calculates motor threshold to quantify nerve damage, for individualized protocol calibration and follow-up efficacy comparison.
Built-in Evidence-Based Expert Preｓcription Library: Pre-installed standardized therapeutic protocols for depression, obsessive-compulsive disorder, stroke, Parkinson’s disease, insomnia, limb spasm and other diseases, one-click to start automatic therapy. Medical staff can store customized personalized parameter protocols.
HD Touch Interactive Terminal: Integrated touch display with visual parameter setting, real-time display of stimulation intensity, frequency, remaining treatment time and total pulse count, simple operation logic for fast proficiency.
Digital Medical Record Management System: Automatically stores patients’ basic inｆormation, target positioning records, historical motor thresholds, all therapy parameters and efficacy records. It supports case retrieval, data export and printing of standardized efficacy reports.
Constant-Temperature Coil Heat Dissipation Protection: Stimulation coils adopt built-in circulating heat dissipation structure with controllable temperature rise during long continuous treatment. The device automatically shuts down with audio-visual alarm when coil temperature exceeds safety threshold to avoid high-temperature scald.
Modular Multi-Coil Quick Replacement: Standard equipped figure-8 focusing coil; optional circular coil and dedicated peripheral nerve coil. Coils support quick plug-and-play replacement, operable by single medical staff.
Multi-Dimensional Real-Time Safety Monitoring: Integrated real-time monitoring for coil detachment, overcurrent, overvoltage, overtemperature, magnetic overload and epilepsy early warning. Stimulation intensity fades in and out gently without sudden strong magnetic impact; output is cut off immediately with audio-visual alarm upon abnormality.
Integrated Silent Mobile Trolley Main Unit: Equipped with silent universal casters. The support bracket supports multi-dimensional lifting, rotation and translation adjustment to adapt to patients of different heights, head shapes and ages, convenient for flexible placement and transfer in treatment rooms.
三、产品特点 Product Features
中文
隔空治疗，零耗材无交叉感染：磁场穿透衣物，无需皮肤电极、导电凝胶，不直接接触人体；无一次性耗材，线圈可重复消毒长期使用，皮肤敏感人群适配度高，杜绝患者间交叉感染风险。
10-20 标准脑定位，低成本易落地：无需配套昂贵 3D 核磁导航设备，依靠国际通用 10-20 定位帽即可锁定治疗靶点，大幅降低基层医疗机构采购与使用成本。
全刺激模式全覆盖，多科室通用：同时具备单脉冲、rTMS、TBS、成对脉冲四大临床核心模式，频率覆盖 0.01–100Hz，兼顾精神科情绪障碍、康复科卒中后遗症、神经内科帕金森、外周神经损伤全病种治疗与神经电生理评定。
选配无线 MEP，客观量化神经功能：无需外接有线电极，双通道无线采集运动诱发电位，AI 全自动测算运动阈值，解决传统仅依靠患者主观感受判断疗效的弊端，实现个体化治疗。
恒温散热，支持全天门诊连续治疗：区别于简易风冷设备，线圈内置循环散热结构，长时间高功率输出无明显温升，超温自动停机保护；适配综合医院、康复中心、精神门诊全天高客流连续治疗场景。
模块化多线圈，一机多用覆盖多部位：全套适配聚焦 8 字、圆形、外周神经三类专用线圈，覆盖大脑浅层皮层、四肢外周神经刺激；线圈快速插拔更换，无需复杂拆装，单人即可操作。
智能梯度强度调节，患者舒适度高：磁场强度 0–200% 运动阈值无级连续可调，升降强度平缓过渡，无瞬时强磁场冲击；治疗全程可实时微调强度，适配不同患者神经耐受度，大幅降低头晕、头胀、心慌、肢体抽搐等不良反应发生率。
内置标准化专家处方库，新手零门槛操作：预装经过多中心临床验证的标准化治疗方案，每种疾病配套标准脉冲参数、治疗时长、疗程安排；医护无需熟记复杂参数，一键调用标准方案即可开展规范治疗。
完整数字化系统，适配医院信息化：全流程自动存储患者诊疗全部数据，支持数据导出、打印、备份；可对接医院 HIS 信息系统，实现患者诊疗数据院内互通，符合医疗机构病案管理规范。
医用级多重安全防护，临床风险极低：搭载线圈脱落、过流、过压、超温、磁场过载、癫痫预警六重安全监测；刺激异常立即切断磁场输出，同步声光报警；设备符合 NMPA 二类医疗器械安全标准，拥有完整 ISO13485 质量体系认证。
English
Non-Invasive Contactless Therapy, Zero Consumables & No Cross-Infection: Magnetic field penetrates clothing without skin electrodes or conductive gel, no direct contact with human body. No disposable consumables; coils can be repeatedly disinfected for long-term use with high adaptability for sensitive skin, eliminating cross-infection risks between patients.
Standard 10-20 Brain Positioning, Low Cost & Easy Deployment: No expensive supporting 3D MRI navigation equipment required. The internationally universal 10-20 positioning cap can accurately lock therapeutic targets, greatly reducing procurement and operating costs for primary medical institutions.
Full Coverage of Stimulation Modes for Multi-Department Universal Use: Equipped with four core clinical modes simultaneously: single pulse, rTMS, TBS theta burst and paired pulse. Frequency ranges 0.01–100Hz, covering treatment and neuroelectrophysiological assessment for all diseases including psychiatric emotional disorders, stroke sequelae in rehabilitation, Parkinson’s disease in neurology and peripheral nerve injury.
Optional Wireless MEP for Objective Quantification of Nerve Function: No external wired electrodes required. Dual-channel wireless acquisition of motor evoked potentials with fully automatic AI motor threshold measurement eliminates drawbacks of traditional efficacy judgment relying only on patients’ subjective feelings and enables precise individualized therapy.
Constant-Temperature Long-Duration Heat Dissipation for All-Day Continuous Outpatient Therapy: Different from simple air-cooled equipment, coils adopt built-in circulating heat dissipation structure without obvious temperature rise during long-time high-power output, with automatic shutdown protection upon overtemperature. Suitable for all-day high-flow continuous treatment scenarios in general hospitals, rehabilitation centers and psychiatric clinics.
Modular Multi-Coil Design, One Device for Multi-Site Therapy: Fully compatible with three types of dedicated coils: focusing figure-8, circular and peripheral nerve coils, covering stimulation of superficial cerebral cortex and peripheral limb nerves. Coils support quick plug-and-play replacement without complex disassembly and assembly, operable by single staff.
Intelligent Gradient Intensity Adjustment for High Patient Comfort: Magnetic field intensity is stepless continuously adjustable from 0–200% motor threshold with gentle transition during intensity increase or decrease, without instantaneous strong magnetic impact. Intensity can be fine-tuned in real time throughout therapy to match individual nerve tolerance of patients, greatly reducing incidence of adverse reactions such as dizziness, head distension, palpitations and limb convulsions.
Built-In Standardized Expert Preｓcription Library with Zero Learning Barrier for Novices: Pre-installed standardized therapeutic protocols verified by multi-center clinical trials, each disease matched with standard pulse parameters, treatment duration and course arrangement. Medical staff do not need to memorize complex parameters and can launch standardized therapy with one-click protocol calling.
Complete Digital Medical Record System Compatible with Hospital Inｆormation Systems: Automatically stores all patient diagnosis and treatment data throughout the whole process, supporting data export, printing and backup. It can connect with hospital HIS inｆormation systems to realize in-hospital sharing of patient diagnosis and treatment data, complying with medical record management specifications of medical institutions.
Medical-Grade Multi-Layer Safety Protection with Ultra-Low Clinical Risk: Equipped with six ｌayers of safety monitoring: coil detachment, overcurrent, overvoltage, overtemperature, magnetic overload and epilepsy early warning. Magnetic field output is cut off immediately with synchronous audio-visual alarm upon abnormal stimulation. The device complies with NMPA Class II medical device safety standards and holds complete ISO13485 quality system certification.
四、技术参数 Technical Specifications
中文
产品型号：Smart-R10
医疗器械注册证：粤械注准 20262090536
整机组成：刺激发生器、刺激线圈（8 字线圈标配，圆形 / 外周线圈选配）、MEP 模块（选配）、10-20 定位帽、可移动静音推车、触控交互终端、支架机械臂、脚踏开关（选配）。
核心刺激模式：单脉冲 TMS、重复 rTMS、TBSθ 爆发刺激、成对脉冲刺激 ppTMS
最大磁感应强度：6T；强度调节范围 0–200% 静息运动阈值，最小调节步进 1% 无级连续可调
脉冲频率参数：输出频率 0.01–100Hz 连续可调；≤1Hz 低频段最小步进 0.1Hz，高频段最小步进 1Hz
脉冲波形指标：双相脉冲波；脉冲上升时间 50µs±10µs；脉冲宽度 340µs±20µs；磁感应强度变化率 40kT/s ~ 80kT/s
治疗时长设置：单次刺激串时长 0.1–60s，串间歇间隔 0–90s；单次总治疗时长 1–60 分钟自由设定
线圈散热系统：内置循环恒温散热；线圈表面温度≥40.5℃自动停机声光报警，连续 30 分钟治疗线圈温升≤1℃
定位系统参数：国际 10-20 脑电定位帽，标准脑功能靶点快速定位，定位操作≤3 分钟完成
选配 MEP 模块参数：双通道无线信号采集；AI 自动识别电位波形，自动测算静息运动阈值；电位幅度测量误差≤5%，信号传输延迟≤1ms
人机交互终端：一体化高清电容触控显示屏，参数可视化界面，支持中文 / 英文双语操作
供电电源：AC220V，50Hz 医用标准交流供电
整机安全分类：I 类 BF 型应用部分，IPX0 防护等级
安全保护机制：线圈脱落、过流、过压、超温、磁场过载、癫痫预警六重实时监测，异常自动切断输出 + 声光报警
工作环境温湿度：工作温度 10℃–35℃，相对湿度 10%–80%，无凝露、无腐蚀性气体
整机设计使用年限：10 年有效使用周期
English
Model Number: Smart-R10
Medical Device Registration Certificate: Yue Xie Zhu Zhun 20262090536
Whole Unit Composition: Stimulation generator, stimulation coils (figure-8 coil as standard, circular/peripheral coils optional), MEP module (optional), 10-20 positioning cap, silent mobile trolley, touch interactive terminal, mechanical arm bracket, foot switch (optional).
Core Stimulation Modes: Single pulse TMS, repetitive rTMS, TBS theta burst stimulation, paired pulse stimulation (ppTMS)
Maximum Magnetic Induction Intensity: 6T; intensity adjustment range 0–200% resting motor threshold, stepless continuous adjustment with minimum step 1%
Pulse Frequency Parameters: Output frequency continuously adjustable 0.01–100Hz; minimum step 0.1Hz for low-frequency range ≤1Hz, minimum step 1Hz for high-frequency range
Pulse Waveｆorm Indicators: Bipolar pulse wave; pulse rise time 50µs±10µs; pulse width 340µs±20µs; magnetic induction change rate 40kT/s ~ 80kT/s
Therapy Duration Setting Range: Single stimulation train duration 0.1–60s, inter-train interval 0–90s; total single therapy duration freely settable 1–60 minutes
Coil Heat Dissipation System: Built-in circulating constant-temperature heat dissipation; automatic shutdown with audio-visual alarm when coil surface temperature ≥40.5℃, coil temperature rise ≤1℃ after 30 consecutive minutes of treatment
Positioning System Parameters: International 10-20 EEG positioning cap for fast positioning of standard brain functional targets; positioning operation completed within 3 minutes
Optional MEP Module Parameters: Dual-channel wireless signal acquisition; AI automatically identifies potential waveｆorms and calculates resting motor threshold automatically; potential amplitude measurement error ≤5%, signal transmission delay ≤1ms
Human-Machine Interaction Terminal: Integrated HD capacitive touch display with visual parameter interface, supporting Chinese/English bilingual operation
Power Supply: AC220V, 50Hz medical standard AC power supply
Whole Unit Safety Classification: Class I BF applied part, IPX0 protection grade
Safety Protection Mechanism: Six ｌayers of real-time monitoring: coil detachment, overcurrent, overvoltage, overtemperature, magnetic overload and epilepsy early warning; output cut off automatically with audio-visual alarm upon abnormality
Operating Ambient Temperature & Humidity: Operating temperature 10℃–35℃, relative humidity 10%–80%, no condensation and no corrosive gas
Designed Service Life of Whole Unit: 10-year effective service cycle
五、使用方法 Operation Procedures
中文
（一）治疗前整机自检与患者准备
设备通电自检：连接医用 AC220V 电源，依次开启刺激发生器、触控终端、散热系统电源；设备自动完成电路、线圈通道、散热模块、定位系统全维度自检，无故障进入主操作界面；若检测故障，屏幕弹窗提示故障类型，禁止开展治疗。
患者术前筛查与告知 ① 完整排查禁忌症：确认患者体内无磁性 / 金属植入器械、无癫痫病史、无 3 个月内颅内出血、无急性期颅脑肿瘤、非孕期；治疗头部无新鲜伤口、破溃、脓肿、活动性出血、皮肤恶性病灶。 ② 告知治疗原理与流程，治疗前要求患者摘除头部金属发卡、眼镜、手机、助听器、项链等所有金属磁性物品，金属物品统一寄存保管，避免磁化或磁场干扰设备。 ③ 嘱患者排空膀胱，治疗全程静坐放松，禁止大幅度晃动头部、起身走动；治疗时全程佩戴隔音耳塞，保护听力，避免脉冲噪音损伤听觉。
线圈与定位系统安装调试 ① 根据治疗部位选择匹配线圈：前额叶抑郁选用 8 字聚焦线圈，四肢外周神经损伤选用外周专用线圈；线圈快速插拔接入主机输出端口，锁紧扣固定稳固，防止治疗中线圈脱落。 ② 佩戴 10-20 定位帽，录入患者基础信息，根据病种选择对应标准靶点（如抑郁症左侧 DLPFC），调整机械臂高度、角度，使线圈平面平行贴合患者头皮，校准线圈与头皮间距，完成靶点定位。
治疗处方参数设置：医护在触控屏根据患者年龄、病程、运动阈值（MEP 测定）选择配套标准化专家处方；系统自动匹配标准频率、刺激串时长、间歇、总治疗时长；初次治疗磁场强度从 30–50% MT 低强度起步，平缓梯度缓慢上调至患者耐受舒适区间；可按需自定义修改脉冲参数，保存个性化方案。
（二）治疗运行全程操作与实时监测
再次复核患者定位、线圈安装、全部刺激参数无误，点击屏幕「启动治疗」，线圈散热系统同步启动循环制冷，设备按照预设参数稳定输出脉冲磁场。
定位实时监护：治疗全程观察患者头部状态，若患者头部大幅度偏移、脱离线圈刺激范围，立即暂停脉冲输出，重新调整患者体位与线圈靶点，确认定位无误后再恢复治疗。
MEP 神经评定操作（选配模块）：如需同步神经功能评定，将 MEP 采集电极贴附患者目标肌肉；设备自动发放单脉冲刺激，AI 实时采集肌肉诱发电位波形，自动测算静息运动阈值，全部评定数据实时自动存储至患者电子。
治疗强度动态调节：治疗过程中每 3–5 分钟主动询问患者头部、全身感受；若患者出现头晕、头胀、头皮刺痛、肢体轻微抽搐、胸闷心慌、耳鸣加重等不适感，医护立即下调磁场强度，必要时暂停治疗休息 5–10 分钟；患者耐受良好无不适，可平缓小幅梯度提升强度，以头部轻微震动、无明显不适感为标准。
全程安全监护：医护人员治疗期间不得离岗，持续观察患者意识、面部表情、肢体活动状态；设备后台实时监测线圈温度、输出电流、磁场强度，线圈温度接近 40℃时设备自动降低输出功率，温度超 40.5℃直接停机并声光报警；若患者突发全身抽搐、意识模糊、剧烈头痛呕吐，立即切断设备输出，开展应急处置。
（三）治疗结束收尾、消毒与设备收纳
预设总治疗时长全部完成后，设备自动停止脉冲磁场输出，线圈散热系统延时 5 分钟循环降温，屏幕弹窗提示本次治疗完成。
病例数据自动归档：系统自动存储本次全部刺激参数、靶点定位坐标、MEP 运动阈值、患者耐受与不良反应记录，归入患者专属电子档案；医护可随时调取历史全部治疗记录，一键导出、打印标准化疗效随访报告。
患者离场与线圈、定位帽消毒：患者缓慢摘下定位帽、取下隔音耳塞后离场；医护取下刺激线圈、定位帽，使用医用稀释季铵盐消毒剂均匀擦拭线圈外壳、定位帽接触面、机械臂支架、推车扶手；擦拭完成后开窗通风静置，等待消毒剂完全自然风干，方可接待下一位患者，严格杜绝患者间交叉感染；禁止使用高浓度 75% 酒精长时间浸泡擦拭线圈，酒精会腐蚀线圈外层绝缘塑胶，缩短设备使用寿命。
设备闲置维护收纳规范 ① 当日间断接诊：关闭触控显示屏背光，刺激发生器与散热系统保持通电待机状态，维持线圈恒温散热循环，便于下一位患者快速启动治疗，减少预热等待时间。 ② 当日全部治疗结束：依次关闭机械臂支架、MEP 模块、线圈散热系统、刺激发生器总电源；将机械臂线圈支架收回归零，整机完整套上原厂防尘罩；每日空载通电运行 10 分钟，驱散散热管路内部潮气，保护磁路、电路精密组件。 ③ 长期闲置超过 7 天：断开设备总供电电源，线圈、定位帽、MEP 电极配件单独分区收纳存放，整机完整套防尘罩隔绝粉尘、水汽；每周固定时段接通整机电源空载运行 15 分钟驱潮保养，防止潮湿腐蚀精密配件老化故障。
English
(1) Pre-Treatment Full-Unit Self-Test & Patient Preparation
Equipment Power-On Self-Test: Connect medical AC220V power supply and turn on power switches of stimulation generator, touch terminal and heat dissipation system in sequence. The equipment completes full-dimensional self-test of circuits, coil channels, heat dissipation modules and positioning system automatically, and jumps to main operation interface if no faults are detected. If faults are detected, pop-up windows on screen indicate fault types and therapy is prohibited.
Pre-Treatment Patient Screening & Notification ① Complete contraindication screening: Confirm patients have no internal magnetic/ｍmbedl implanted devices, no epilepsy history, no intracranial hemorrhage within 3 months, no acute phase intracranial tumors and are non-pregnant; no fresh wounds, broken skin, abscesses, active bleeding or malignant skin lesions on the head treatment area. ② Explain non-invasive therapy principle and procedure. Instruct patients to remove all ｍmbedl and magnetic items on the head including ｍmbedl hair clips, glasses, mobile phones, hearing aids and necklaces before therapy; all ｍmbedl items shall be stored uniｆormly to avoid magnetization or magnetic field interference with equipment. ③ Advise patients to empty the bladder and maintain a sitting relaxed state throughout therapy; large-scale head shaking and walking around are prohibited. Patients shall wear sound-insulating earplugs throughout therapy to protect hearing and avoid auditory damage caused by pulse noise.
Coil & Positioning System Installation & Debugging ① Select matched coil according to treatment site: figure-8 focusing coil for prefrontal lobe depression, dedicated peripheral coil for limb peripheral nerve injury. Hot-swap the coil into the main unit output port and fasten the lock buckle firmly to prevent coil detachment during therapy. ② Patients wear the 10-20 positioning cap. Input patient basic inｆormation and select corresponding standard target according to disease type (e.g., left DLPFC for depression). Adjust the height and angle of mechanical arm to make the coil plane fit the patient’s scalp in parallel, calibrate the distance between coil and scalp and complete target positioning.
Therapeutic Preｓcription Parameter Setting: Medical staff select matched standardized expert preｓcriptions on the touch screen according to patient age, disease course and motor threshold (measured by MEP). The system automatically matches standard frequency, stimulation train duration, interval and total therapy duration. For initial therapy, magnetic field intensity starts from low intensity of 30–50% MT and is slowly increased in gentle gradients to the patient’s comfortable tolerance range. Pulse parameters can be customized and modified as needed to save personalized protocols.
(2) Full-Process Therapy Operation & Real-Time Monitoring
Double-check patient positioning, coil installation and all stimulation parameters for accuracy, then click "Start Therapy" on screen. The coil heat dissipation system starts circulating refrigeration synchronously, and the equipment outputs pulsed magnetic field stably according to preset parameters.
Real-Time Positioning Monitoring: Observe the patient’s head status throughout therapy. If the patient’s head shifts drastically and deviates from the coil stimulation range, pause pulse output immediately, readjust the patient’s posture and coil target, and resume therapy only after confirming accurate positioning.
MEP Nerve Assessment Operation (Optional Module): If synchronous nerve function assessment is required, attach MEP collection electrodes to the patient’s target muscles. The equipment automatically emits single-pulse stimulation, the AI collects muscle evoked potential waveｆorms in real time and automatically calculates resting motor threshold. All assessment data is automatically stored into the patient’s electronic medical record instantly.
Dynamic Therapy Intensity Adjustment: Actively inquire about the patient’s head and whole-body sensations every 3–5 minutes during therapy. If the patient experiences dizziness, head distension, scalp stinging pain, slight limb convulsions, chest tightness, palpitations or aggravated tinnitus, medical staff shall immediately reduce magnetic field intensity and pause therapy for 5–10 minutes for rest if necessary. If the patient has good tolerance without discomfort, intensity can be slightly increased in gentle gradients, with the standard of slight head vibration without obvious discomfort.
Full-Process Safety Supervision: Medical staff shall not leave their posts during therapy and continuously observe the patient’s consciousness, facial expressions and limb movements. The equipment background monitors coil temperature, output current and magnetic field intensity in real time. The equipment automatically reduces output power when coil temperature approaches 40℃, and shuts down with audio-visual alarm directly when temperature exceeds 40.5℃. If the patient suffers sudden general convulsions, confusion, severe headache and vomiting, cut off equipment output immediately and carry out emergency disposal.
(3) Post-Treatment Closing Procedures, Disinfection & Equipment Storage
After completion of preset total therapy duration, the equipment automatically stops pulsed magnetic field output. The coil heat dissipation system runs delayed 5-minute circulating cooling, and a pop-up window on screen prompts completion of current therapy.
Automatic Filing of Case Data: The system automatically stores all stimulation parameters, target positioning coordinates, MEP motor thresholds and records of patient tolerance and adverse reactions of this session into the patient’s exclusive electronic medical record file. Medical staff can retrieve all historical therapy records at any time, and export or print standardized efficacy follow-up reports with one click.
Patient Departure & Disinfection of Coils and Positioning Caps: Patients slowly take off the positioning cap and sound-insulating earplugs before leaving. Medical staff remove the stimulation coil and positioning cap, and evenly wipe the coil housing, all contact surfaces of positioning cap, mechanical arm brackets and trolley handrails with medical diluted quaternary ammonium salt disinfectant. Open windows for ventilation and stand still after wiping until the disinfectant air-dries completely before receiving the next patient to strictly eliminate cross-infection risks between patients. Long-time soaking and wiping of coils with high-concentration 75% alcohol is prohibited; alcohol will corrode the outer insulating plastic of coils and shorten equipment service life.
Idle Equipment Maintenance & Storage Specifications ① Intermittent daily outpatient visits: Turn off the backlight of touch display screen, keep the stimulation generator and heat dissipation system powered on standby to maintain constant-temperature coil heat dissipation circulation, for fast therapy startup for subsequent patients and reduce preheating waiting time. ② End of all daily therapy sessions: Turn off power switches of mechanical arm bracket, MEP module, coil heat dissipation system and stimulation generator in sequence. Retract and reset the mechanical arm coil bracket, fully cover the whole unit with original factory dust-proof cover. Power on and run no-load for 10 minutes every day to dispel internal moisture in heat dissipation pipelines and protect precision magnetic circuit and circuit components. ③ Long-term idle over 7 days: Cut off the main power supply of the equipment, store coils, positioning caps and MEP electrode accessories separately in partitioned storage areas, and fully cover the whole unit with dust-proof cover to isolate dust and water vapor. Power on and run no-load for 15 minutes at fixed time every week for moisture removal maintenance to prevent aging and failure of precision accessories caused by damp corrosion.
六、适应症 Indications
中文
依据医疗器械注册证官方预期用途：用于人体中枢神经和外周神经功能的检测、评定及辅助治疗，全程需在具备资质的执业医师指导下操作使用。 细分临床适配病症：
精神心理科适应症 重度抑郁症、难治性抑郁症、强迫症、创伤后应激障碍（PTSD）、广泛性焦虑障碍、精神分裂症阴性症状、神经源性失眠（神经功能紊乱引发睡眠障碍）、双相情感障碍稳定期辅助干预、物质成瘾辅助治疗。
神经内科 / 康复科适应症 脑卒中（脑出血、脑梗死）后遗症偏瘫、肢体痉挛、吞咽障碍、失语、认知障碍；脑外伤后运动、认知、语言功能缺损；帕金森病运动迟缓、肌张力增高；多发性硬化神经功能缺损；脊髓损伤后运动、排尿排便功能障碍；轻度认知障碍、阿尔茨海默病早期干预。
神经痉挛与疼痛类病症 脑卒中、脑外伤后肢体肌张力异常增高、肌肉痉挛；偏头痛、神经病理性疼痛、纤维肌痛综合征；耳鸣、幻听辅助干预。
儿童神经发育类适应症（医师严格评估后使用） 注意缺陷多动障碍 ADHD、孤独症谱系障碍、抽动障碍、儿童卒中后康复。
外周神经损伤适应症 尺神经、桡神经、腓总神经等四肢外周神经卡压、损伤；神经源性肌肉萎缩、肢体麻木、感觉减退。
神经电生理评定用途（选配 MEP 模块） 运动诱发电位 MEP 检测，测算静息运动阈值，量化大脑皮层、外周神经传导功能损伤程度；用于术前神经功能基线评估、康复治疗疗效客观随访对比、科研脑功能检测。
English
Official intended use per medical device registration certificate: For detection, evaluation and adjuvant treatment of human central nervous system and peripheral nervous system functions. All operations must be conducted under the guidance of qualified licensed physicians. Subdivided clinically applicable diseases:
Psychiatric & Psychological Indications Major depressive disorder, refractory depression, obsessive-compulsive disorder, post-traumatic stress disorder (PTSD), generalized anxiety disorder, negative symptoms of schizophrenia, neurogenic insomnia (sleep disorder induced by neurological dysfunction), adjuvant intervention for stable phase of bipolar disorder, adjuvant therapy for substance addiction.
Neurology & Rehabilitation Indications Sequelae of stroke (cerebral hemorrhage, cerebral infarction) including hemiplegia, limb spasm, dysphagia, aphasia and cognitive impairment; motor, cognitive and language function deficits after traumatic brain injury; bradykinesia and increased muscle tension of Parkinson’s disease; neurological deficits of multiple sclerosis; motor, urination and defecation dysfunction after spinal cord injury; early intervention for mild cognitive impairment and Alzheimer’s disease.
Neural Spasm & Pain Diseases Abnormally increased muscle tension and limb spasm after stroke and traumatic brain injury; migraine, neuropathic pain, fibromyalgia syndrome; adjuvant intervention for tinnitus and auditory hallucinations.
Pediatric Neurodevelopmental Indications (Used after strict physician assessment) Attention deficit hyperactivity disorder (ADHD), autism spectrum disorder, tic disorder, rehabilitation after pediatric stroke.
Peripheral Nerve Injury Indications Entrapment and injury of limb peripheral nerves including ulnar nerve, radial nerve and common peroneal nerve; neurogenic muscular atrophy, limb numbness and hypoesthesia.
Neuroelectrophysiological Assessment Application (Optional MEP Module) Motor Evoked Potential (MEP) detection to calculate resting motor threshold and quantify the damage degree of cerebral cortex and peripheral nerve conduction function; used for preoperative baseline neurological function evaluation, ｏbjective follow-up comparison of rehabilitation efficacy and brain function detection for scientific research.
七、禁忌症 Contraindications
中文
绝对禁忌症（严禁使用本设备开展磁刺激治疗，风险极高）
体内植入磁性 / 金属电子器械：心脏起搏器、植入式心律转复除颤器 ICD、颅内金属支架、人工耳蜗、颅内 / 脊柱金属钢板、钢钉、植入神经刺激器、脑深部电刺激 DBS 装置、颅内动脉瘤金属夹。
颅内存在金属异物、颅内恶性肿瘤病灶、近 3 个月内颅内出血、急性期重度颅脑损伤、颅内高压、急性脑积水。
确诊癫痫、有明确全身抽搐、惊厥发作病史，或直系亲属有癫痫病史人群（磁刺激存在诱发癫痫发作风险）。
治疗头部区域存在新鲜开放性伤口、烧伤、脓肿、急性皮炎、活动性出血、头部皮肤恶性肿瘤病灶。
全孕期妊娠期女性（磁场可能干扰胎儿神经系统发育，禁止头部经颅磁刺激）。
严重凝血功能障碍、活动性颅内 / 全身大出血、未控制血友病患者；有出血倾向、近期大型手术未愈合人群。
对交变脉冲磁场极度敏感，既往磁刺激治疗后出现持续性剧烈头晕、晕厥、全身抽搐、严重心慌休克病史人群。
晚期恶性肿瘤、全身广泛多发肿瘤转移、生命体征不稳定危重患者。
颅内感染急性期（脑膜炎、脑炎）伴随高热、剧烈头痛、意识障碍患者。
相对禁忌症（必须经执业医师风险获益评估，全程严密心电、意识监护，仅可低强度、短时谨慎治疗）
严重心功能不全、不稳定心绞痛、3 个月内急性心肌梗死病史、严重未控制心律失常人群。
重度高血压，血压持续≥180/110mmHg 且药物无法稳定控制。
重度骨质疏松、颅底 / 颅骨陈旧性未愈合骨折、严重脊柱畸形。
精神极度躁动、躁狂急性发作、认知障碍无法长时间静坐配合头部定位治疗、存在高自杀冲动风险患者。
头部皮肤重度感觉减退、麻木，无法自主感知磁场刺激强度，不能及时反馈头晕、刺痛等不适症状人群。
青光眼、视网膜脱落、严重眼底病变患者。
肝肾功能重度衰竭、重度电解质紊乱未纠正人群。
2 岁以下婴幼儿、75 岁以上高龄老年患者，神经耐受度弱，需大幅降低刺激强度、缩短单次治疗时长。
同时使用电休克疗法、服用降低癫痫阈值精神类药物患者。
严重听力损伤、佩戴耳毒性药物治疗人群，需强化听力防护，严格控制高频刺激时长。
English
Absolute Contraindications (Magnetic stimulation therapy with this equipment is strictly prohibited with extremely high risks)
Implanted magnetic/ｍmbedl electronic devices in the body: Cardiac pacemakers, implantable cardioverter defibrillators (ICD), intracranial ｍmbedl stents, cochlear implants, intracranial/spinal ｍmbedl plates and screws, permanently implanted nerve stimulators, deep brain stimulation (DBS) devices, intracranial aneurysm ｍmbedl clips.
Intracranial ｍmbedl foreign bodies, intracranial malignant tumor lesions, recent intracranial hemorrhage (within 3 months), acute phase severe craniocerebral injury, intracranial hypertension and acute hydrocephalus.
Confirmed epilepsy or medical history of generalized convulsions and seizures, or immediate family members with epilepsy history (magnetic stimulation carries risk of inducing epileptic seizures).
Fresh open wounds, burns, abscesses, acute dermatitis, active bleeding and malignant skin tumor lesions on the head treatment area.
Pregnant women throughout gestation (magnetic field may interfere with fetal nervous system development; transcranial magnetic stimulation on the head is prohibited).
Patients with severe coagulation disorders, active intracranial/systemic massive hemorrhage or uncontrolled hemophilia; crowds with bleeding tendency or unhealed major recent surgery.
Crowds extremely sensitive to alternating pulsed magnetic field with medical history of persistent severe dizziness, syncope, generalized convulsions or severe palpitations and shock after previous magnetic stimulation therapy.
Critically ill patients with advanced malignant tumors, extensive systemic multiple tumor ｍmbedstases and unstable vital signs.
Patients with acute phase intracranial infection (meningitis, encephalitis) accompanied by high fever, severe headache and consciousness disturbance.
Relative Contraindications (Comprehensive risk-benefit assessment by licensed physicians is mandatory; continuous close cardiac and consciousness monitoring throughout therapy, only cautious short-duration low-intensity treatment allowed)
Crowds with severe cardiac insufficiency, unstable angina, medical history of acute myocardial infarction within 3 months or uncontrolled severe arrhythmia.
Severe hypertension with sustained blood pressure ≥180/110mmHg that cannot be stably controlled by medication.
Severe osteoporosis, unhealed old skull/base of skull fractures and severe spinal deｆormities.
Patients with extreme mental agitation, acute manic episodes, cognitive impairment unable to sit still for a long time and cooperate with head positioning therapy, or high risk of suicidal impulses.
Crowds with severe hypoesthesia or numbness of head skin, unable to independently perceive magnetic stimulation intensity and timely feedback discomfort such as dizziness and stinging pain.
Patients with glaucoma, retinal detachment and severe fundus lesions.
Crowds with severe liver and kidney failure or uncorrected severe electrolyte disorders.
Infants under 2 years old and elderly patients over 75 years old with weak nerve tolerance; stimulation intensity must be greatly reduced and single therapy duration shortened significantly.
Patients receiving concurrent electroconvulsive therapy or taking psychiatric drugs that lower epilepsy threshold.
Crowds with severe hearing impairment or receiving ototoxic drug treatment; hearing protection must be strengthened and high-frequency stimulation duration strictly controlled.
八、注意事项 Precautions
中文
（一）设备操作安全规范
治疗前强制金属筛查：严格检查患者全身、头部所有金属、磁性物品，手机、金属发卡、眼镜、助听器、项链、磁卡、钥匙全部统一寄存，严禁带入磁场刺激区域；体内植入电子器械患者直接禁止治疗，避免磁场干扰植入设备引发心律失常、器械故障危及生命。
磁场定向硬性规范：刺激线圈仅可对准大脑皮层、四肢外周神经靶区域，严禁将线圈对准眼球、心脏、甲状腺、生殖盆腔脏器、脑干延髓；磁场穿透性强，近距离刺激上述敏感脏器极易引发肌肉痉挛、脏器功能损伤、视力受损。
强度梯度调节硬性要求：所有初次治疗、高龄、儿童、心脑血管基础病、焦虑抑郁重症患者，磁场强度必须从最低 30–50% 运动阈值起步，平缓梯度缓慢上调；禁止直接设置高磁场强度启动治疗，极易诱发头晕、抽搐、心慌、癫痫样发作等严重不良反应。
设备运行中禁止拆装配件：治疗过程中严禁热插拔线圈、拆卸定位帽、拆解主机、散热机组外壳；如需更换线圈、检修配件，必须点击屏幕停机、切断设备总电源，等待散热系统停止循环、线圈降温后再拆装操作。
故障应急处置流程：设备运行中出现异响、焦糊异味、屏幕故障报错、线圈频繁超温自动停机、机械臂卡顿偏移等异常，立即切断整机总电源，停止一切操作；禁止医护自行拆机检修内部磁路、电路、散热管路组件，时间联系厂家专业售后工程师上门维修。
电源使用规范：设备必须使用标准医用 AC220V 独立供电插座，禁止与高频电刀、核磁、CT、大功率理疗设备共用同一插排；供电线路需接地良好，防止静电、漏电干扰设备磁场输出精度，避免触电安全隐患。
（二）患者临床全程监护规范
全程不可离岗监护：医护人员治疗全程不得脱岗离岗，每 3–5 分钟主动询问患者头部、全身感受，持续观察患者面部表情、肢体活动、意识状态；重点监测头晕、恶心呕吐、剧烈头胀、肢体不自主抽搐、胸闷心慌、视物模糊、耳鸣加重等不良症状，出现不适立刻处置。
突发不适标准化应急处理 ① 轻度不适（头晕、头皮刺痛、轻微耳鸣）：立即下调磁场强度，缩短单次刺激串时长，观察 5 分钟；无缓解则暂停治疗，让患者静坐休息 5–10 分钟，补充少量温水，症状缓解后可降低强度继续治疗。 ② 中度不适（剧烈头痛、恶心想吐、肢体轻微抽搐、心慌气短）：立刻点击停机切断磁场输出，搀扶患者缓慢平躺于诊疗床，保持呼吸通畅，持续监测血压、心率、血氧饱和度，待症状完全消失后评估是否终止本次疗程。 ③ 重度急症（全身持续抽搐、意识丧失、剧烈呕吐、呼吸困难）：立即切断设备总电源，清理患者口腔呕吐物保持气道通畅，侧卧位防止呛咳窒息；时间启动院内急救流程，呼叫急诊科、神经内科医师现场会诊急救。
特殊人群专项监护细则 ① 孕妇：绝对禁用，严禁开展任何头部磁刺激。 ② 2 岁以下婴幼儿、75 岁以上老人：全程低强度刺激方案，单次治疗时长缩短至 10–15 分钟；治疗前后各监测一次血压、心率，指标异常即刻终止治疗。 ③ 高血压、冠心病、脑梗后遗症、帕金森、重度焦虑抑郁患者：治疗前服用常规药物稳定基础病，全程心电监护，实时监测生命体征，出现胸闷、头晕、血压骤升立即停机。 ④ 听力损伤、耳鸣患者：全程佩戴双层隔音耳塞，严格限制高频刺激总时长，每 10 分钟暂停刺激休息 2 分钟，避免脉冲噪音加重听觉损伤。
治疗前患者身体状态管控要求 ① 禁止空腹、重度疲劳、熬夜失眠、大量饮酒、服用兴奋性精神类药物后开展磁刺激治疗。 ② 治疗前可饮用少量温水，避免过度饥饿、低血糖诱发头晕加重；治疗前 2 小时禁止饮用浓茶、咖啡、能量饮料、酒精饮品等刺激性饮品。 ③ 治疗前充分休息，情绪保持平稳放松；情绪极度激动、烦躁、焦虑发作时禁止开展治疗，待情绪平复后再进行。
（三）院感消毒、设备维护保养规范
单人单次治疗后强制消毒流程：每位患者治疗结束离场后，必须使用医用稀释季铵盐消毒剂均匀擦拭刺激线圈外壳、定位帽全部接触面、机械臂支架、推车扶手支架；擦拭完成后开窗通风静置，等待消毒剂完全自然风干，方可接待下一位患者，严格杜绝患者间交叉感染风险；禁止使用 75% 高浓度酒精、84 消毒液、丙酮、酒精湿巾长时间擦拭、浸泡线圈，此类腐蚀性液体会腐蚀线圈外层绝缘塑胶，加速线圈老化开裂，大幅缩短设备使用寿命。
精密线圈、机械臂光学组件养护规范 ① 刺激线圈内部为高精度磁路核心组件，禁止大力磕碰、摔落、重物挤压线圈；转运、收纳时线圈单独用防震泡沫包裹存放，避免挤压变形。 ② 机械臂、定位支架无光学镜头，但金属支架易氧化；禁止消毒液、水渍长时间浸泡金属支架，擦拭后及时风干，定期涂抹医用防锈护理剂，防止支架生锈卡顿。
线缆、散热管路防护要求 ① 线圈连接线、MEP 模块传输信号线、电源供电线缆避免过度弯折、大力拉扯、尖锐物品切割损伤；每周定期检查全部线缆外皮是否破损、内部金属线芯裸露，发现破损配件立即停止使用并更换原厂配件，禁止破损线缆继续通电使用，存在漏电、短路起火风险。 ② 散热循环管路禁止弯折挤压、重物碾压；每年由厂家售后工程师上门检修散热管路、更换专用导热冷却液，防止管路堵塞、腐蚀渗漏，造成线圈散热失效、高温损坏磁路。
整机清洁禁止喷淋水洗规范：刺激发生器、散热机组、触控一体机、机械臂、静音推车整机严禁直接使用清水喷淋冲洗；日常清洁仅可使用微湿消毒无尘软抹布轻柔擦拭设备外壳、屏幕表面；严格避免液体渗入主机内部电路、磁路、散热管路组件，液体渗漏会造成电路短路烧毁核心精密部件，维修成本极高。
（四）诊室环境、设备存储转运规范
电磁隔离摆放硬性要求：磁刺激设备放置治疗诊室区域，必须远离高频电刀、射频消融仪、核磁共振 MRI、CT、X 光机、大功率超声等强电磁医疗设备；强电磁干扰会造成本设备磁场输出参数紊乱、MEP 神经检测数据失真、靶点定位坐标偏移，直接降低治疗度与疗效稳定性；设备与大型影像、高频手术设备最小安全间距≥3 米。
诊室环境温湿度管控：治疗诊室全程保持干燥、通风状态，环境相对湿度不可超过 80%，防止主机内部电路板受潮短路、金属机械支架锈蚀、散热管路内壁滋生霉菌堵塞管路；设备远离洗手水池、消毒喷淋、水源潮湿区域摆放，地面保持干燥无积水，避免水渍溅射到设备主机、线圈、触控屏幕。
长期闲置设备定期驱潮保养规范：设备停用闲置时长超过 7 天时，整机完整套上原厂专用防尘罩隔绝粉尘、水汽；每周固定时段接通整机总电源空载运行 10–15 分钟，启动散热循环系统驱散主机、线圈、管路内部积聚潮气，保护精密电路、磁路组件，避免潮湿腐蚀老化核心配件引发设备故障。
转运、跨科室移动防护规范：设备在诊室间转运、物流长途运输时，线圈、定位帽、MEP 模块、机械臂支架配件单独使用加厚防震泡沫完整包裹，整机外部加装密封防潮防护包装箱；转运全程避免雨淋浸泡、露天阳光暴晒、剧烈颠簸撞击、重型货物堆叠重压主机与精密线圈组件；剧烈震动会造成线圈内部磁芯移位变形，破坏磁场输出精度，设备丧失治疗功能。
English
(1) Safe Equipment Operation Specifications
Mandatory ｍmbedl screening before therapy: Strictly check all ｍmbedl and magnetic items on the patient’s head and whole body. Mobile phones, ｍmbedl hair clips, glasses, hearing aids, necklaces, magnetic cards and keys shall be stored uniｆormly and are prohibited from being brought into the magnetic stimulation area. Patients with implanted electronic devices are directly forbidden from therapy to avoid magnetic field interference triggering arrhythmia, equipment failure and life-threatening risks.
Mandatory magnetic field orientation specifications: Stimulation coils can only be aligned with target areas of cerebral cortex and peripheral limb nerves. It is strictly prohibited to aim coils at eyeballs, heart, thyroid gland, pelvic reproductive viscera and medulla oblongata of brainstem. The magnetic field has strong penetration; close-range stimulation of these sensitive organs easily causes muscle spasm, visceral function damage and visual impairment.
Mandatory gradient intensity adjustment requirements: For all initial therapy, elderly, children, patients with underlying cardiovascular and cerebrovascular diseases and severe anxiety/depression patients, magnetic field intensity must start from the minimum 30–50% motor threshold and be slowly increased in gentle gradients. Directly setting high magnetic field intensity to start therapy is forbidden, as it may easily induce severe adverse reactions including dizziness, convulsions, palpitations and epileptiｆorm seizures.
Disassembly of accessories prohibited during equipment operation: Hot-swap of coils, disassembly of positioning caps and dismantling of main unit/heat dissipation unit housing are strictly prohibited during therapy. To replace coils or maintain accessories, click stop on screen, cut off the main power supply of the equipment, and wait for the heat dissipation system to stop circulation and coils to cool down before disassembly and assembly operations.
Fault emergency disposal procedure: If abnormal phenomena such as strange noise, burnt odor, screen error codes, frequent automatic shutdown of coils due to overtemperature and stuck offset of mechanical arm occur during equipment operation, cut off the main power supply of the whole unit immediately and stop all operations. Medical staff are strictly prohibited from disassembling the equipment to inspect internal magnetic circuits, circuits and heat dissipation pipeline components by themselves; contact professional after-sales engineers of the manufacturer for on-site maintenance as soon as possible.
Power supply usage specifications: The equipment must use an independent medical AC220V power socket. Sharing the same power strip with high-frequency electrosurgical units, MRI, CT and high-power physiotherapy equipment is prohibited. The power supply circuit must be well grounded to prevent static electricity and electric leakage from interfering with equipment magnetic field output accuracy and eliminate electric shock safety hazards.
(2) Full-Process Clinical Patient Monitoring Specifications
Uninterrupted on-duty monitoring: Medical staff shall not leave their posts throughout therapy. Actively inquire about the patient’s head and whole-body sensations every 3–5 minutes, and continuously observe the patient’s facial expressions, limb movements and consciousness status. Focus on monitoring adverse symptoms including dizziness, nausea and vomiting, severe head distending pain, involuntary limb convulsions, chest tightness and palpitations, blurred vision and aggravated tinnitus; dispose immediately once discomfort occurs.
Standardized emergency handling for sudden discomfort ① Mild discomfort (dizziness, scalp stinging pain, slight tinnitus): Immediately reduce magnetic field intensity, shorten single stimulation train duration and observe for 5 minutes. If there is no relief, pause therapy, let the patient sit quietly and rest for 5–10 minutes, supplement a small amount of warm water; therapy can be continued with reduced intensity after symptoms are relieved. ② Moderate discomfort (severe headache, nausea and vomiting, slight limb convulsions, chest tightness and shortness of breath): Click stop immediately to cut off magnetic field output, assist the patient to lie flat slowly on the diagnosis and treatment bed, keep unobstructed breathing, and continuously monitor blood pressure, heart rate and blood oxygen saturation. Evaluate whether to terminate the current treatment course after symptoms completely disappear. ③ Severe emergency (sustained generalized convulsions, loss of consciousness, severe vomiting, dyspnea): Cut off the main power supply of the equipment immediately, clean up vomit in the patient’s oral cavity to keep the airway unobstructed, and place the patient in lateral position to prevent choking and suffocation. Activate the hospital emergency procedure immediately and call emergency and neurology physicians for on-site consultation and first aid.
Special monitoring rules for high-risk groups ① Pregnant women: Absolutely prohibited; any head magnetic stimulation is forbidden. ② Infants under 2 years old and elderly over 75 years old: Adopt low-intensity stimulation protocols throughout therapy, shorten single therapy duration to 10–15 minutes. Monitor blood pressure and heart rate once before and after therapy, and terminate therapy immediately upon abnormal indicators. ③ Patients with hypertension, coronary heart disease, stroke sequelae, Parkinson’s disease and severe anxiety/depression: Take routine medication before therapy to stabilize underlying diseases, conduct continuous cardiac monitoring and real-time monitoring of vital signs. Stop therapy immediately upon chest tightness, dizziness or sudden blood pressure surge. ④ Patients with hearing impairment and tinnitus: Wear double-ｌayer sound-insulating earplugs throughout therapy, strictly limit total high-frequency stimulation duration, pause stimulation and rest for 2 minutes every 10 minutes to avoid aggravation of auditory damage caused by pulse noise.
Patient physical state control requirements before therapy ① Magnetic stimulation therapy is prohibited for patients on an empty stomach, severely fatigued, sleep-deprived, after heavy drinking or taking excitatory psychiatric drugs. ② Patients may drink a small amount of warm water before therapy to avoid aggravated dizziness caused by excessive hunger and hypoglycemia. Drinking stimulating beverages such as strong tea, coffee, energy drinks and alcoholic beverages is prohibited within 2 hours before therapy. ③ Get sufficient rest before therapy and keep stable and relaxed mood. Therapy is prohibited when the patient is extremely agitated, irritable or experiencing acute anxiety attacks; conduct therapy only after mood calms down.
(3) Hospital Infection Disinfection & Equipment Maintenance Specifications
Mandatory disinfection procedure after single patient therapy: After each patient completes therapy and leaves, evenly wipe the stimulation coil housing, all contact surfaces of positioning cap, mechanical arm brackets and trolley handrail brackets with medical diluted quaternary ammonium salt disinfectant. Open windows for ventilation and stand still after wiping until the disinfectant air-dries completely before receiving the next patient to strictly eliminate cross-infection risks between patients. Long-time wiping and soaking of coils with high-concentration 75% alcohol, 84 disinfectant, acetone and alcohol wipes are prohibited. Such corrosive liquids will corrode the outer insulating plastic of coils, accelerate coil aging and cracking, and greatly shorten equipment service life.
Maintenance specifications for precision coils and mechanical arm optical components ① The interior of stimulation coils consists of high-precision core magnetic circuit components. Rough impact, dropping and heavy extrusion of coils are prohibited. Wrap coils separately with shock-proof foam for storage and transportation to avoid extrusion and deｆormation. ② The mechanical arm and positioning brackets have no optical lenses, but ｍmbedl brackets are prone to oxidation. Long-time soaking of ｍmbedl brackets with disinfectant and water stains is prohibited. Dry thoroughly after wiping, and apply medical anti-rust care agent regularly to prevent bracket rust and jamming.
Protection requirements for cables and heat dissipation pipelines ① Avoid excessive bending, violent pulling and cutting damage from sharp ｏbjects to coil connecting cables, MEP module transmission signal lines and power supply cables. Inspect the outer skin of all cables weekly for breakage or exposed internal ｍmbedl cores. Stop using damaged accessories immediately and replace with brand-new original factory accessories; continuous power-on use of damaged cables is prohibited due to risks of electric leakage and short-circuit fire. ② Bending, extrusion and heavy rolling of heat dissipation circulating pipelines are prohibited. Professional after-sales engineers of the manufacturer shall conduct on-site inspection of heat dissipation pipelines and replace special thermal conductive coolant every year to prevent pipeline blockage, corrosion and leakage, resulting in coil heat dissipation failure and high-temperature damage to magnetic circuits.
Whole-unit cleaning prohibition of water spray washing specifications: Direct water spray flushing of stimulation generator, heat dissipation unit, touch all-in-one machine, mechanical arm and silent trolley whole unit is strictly prohibited. Daily cleaning can only be carried out by gently wiping equipment housing and screen surface with slightly damp disinfection dust-free soft rags. Strictly prevent liquid infiltration into internal circuits, magnetic circuits and heat dissipation pipeline components of the main unit; liquid leakage will cause circuit short circuits to burn core precision parts with extremely high maintenance costs.
(4) Treatment Room Environment, Equipment Storage & Transfer Specifications
Mandatory electromagnetic isolation placement requirements: The magnetic stimulation equipment must be placed far away from high-frequency electrosurgical units, radiofrequency ablation instruments, MRI, CT, X-ray machines, high-power ultrasound and other strong electromagnetic medical equipment in the treatment room. Strong electromagnetic interference will disrupt magnetic field output parameters of this equipment, distort MEP nerve detection data and offset target positioning coordinates, directly reducing therapy precision and efficacy stability. The minimum safe distance between the equipment and large imaging and high-frequency surgical equipment shall be ≥3 meters.
Treatment room temperature and humidity control: The treatment room must be kept dry and ventilated throughout the whole period, with ambient relative humidity not exceeding 80% to prevent damp short circuits of internal main unit circuit boards, rusting of ｍmbedl mechanical brackets and mold growth inside heat dissipation pipelines causing pipeline blockages. Place the equipment far away from hand washing sinks, disinfection spray areas and humid water source zones, keep the ground dry without water accumulation, and avoid water splashing on equipment main unit, coils and touch screens.
Regular moisture removal maintenance specifications for long-term idle equipment: When the equipment is idle for more than 7 days, fully cover the whole unit with the original factory dedicated dust-proof cover to isolate dust and water vapor. Power on the whole unit at fixed time every week and run no-load for 10–15 minutes, activate the heat dissipation circulating system to dispel accumulated moisture inside the main unit, coils and pipelines, protect precision circuits and magnetic circuit components, and avoid aging and failure of core accessories caused by damp corrosion.
Transfer and inter-department mobile protection specifications: During inter-room transfer and long-distance logistics transportation of the equipment, separately wrap coils, positioning caps, MEP modules and mechanical arm bracket accessories with thick shock-proof foam, and install a sealed moisture-proof protective packaging box outside the whole unit. Avoid rain soaking, open-air sun exposure, severe bumping impact and stacking heavy goods to squeeze the main unit and precision coil components throughout transfer. Severe vibration will cause displacement and deｆormation of magnetic cores inside coils, permanently damaging magnetic field output accuracy and rendering the equipment completely incapable of therapeutic functions.
九、存储条件 Storage Conditions
中文
存储温度标准：设备长期仓储、诊室闲置存放环境温度稳定维持 5℃ ~ 40℃；禁止存放于 0℃以下低温冷冻环境、45℃以上高温阳光暴晒环境。低温会造成设备内部电路板、线圈磁芯电子元器件失效损坏；高温加速散热冷却液老化变质、线圈绝缘塑胶老化脆裂，大幅缩短整机 10 年设计使用周期。
存储湿度标准：存储库房、治疗诊室环境相对湿度严格控制在 10% ~ 80%，存储区域全程无凝露、无积水、无渗水；过高环境湿度会引发主机电路板受潮短路、金属机械支架、线圈内部金属磁芯锈蚀、散热管路内壁滋生霉菌堵塞循环管路，造成设备故障停机、配件锈蚀报废。
避光存储硬性要求：整机、线圈、定位帽、触控显示屏配件存储必须避光放置，远离阳光直射窗户、紫外线消毒灯长期持续照射区域；长期强光、紫外线照射会造成设备外壳塑料材质老化变脆开裂、触控屏幕背光组件衰减老化，降低屏幕显示清晰度与使用寿命；散热管路塑胶管材长期光照会加速老化渗漏，导致线圈散热失效高温损坏磁路。
存储区域洁净度与气体隔离要求：设备存放库房、诊室区域必须保持干燥通风、无尘洁净；远离甲醛、高浓度酒精、雾化消毒气体、强酸强碱、挥发性腐蚀性化学试剂存放区域；腐蚀性挥发气体持续接触设备金属支架、电路接口、线圈磁芯、散热管路，会造成金属氧化锈蚀、电路触点接触不良、管路腐蚀渗漏故障，大幅提升设备维修更换成本。
堆叠摆放仓储规范：设备整机、配件外包装纸箱必须水平平放存储，严格禁止倒置、侧立倾斜摆放、重型重物堆叠重压覆盖设备整机与线圈精密配件；线圈内部高精度磁路磁芯抗压性能极差，重压挤压极易造成磁芯移位变形，破坏磁场输出精度，设备丧失治疗功能；设备转运仓储堆叠总高度不得超过 4 层，每层之间加装防震缓冲隔板。
分区隔离存放规范：Smart-R10 磁刺激仪刺激主机、散热机组、刺激线圈、定位帽、MEP 传感模块、配套信号线、机械臂支架配件必须单独分区隔离存放；严禁与消杀消毒化学品、强酸强碱化学试剂、生活垃圾、带水潮湿杂物混放存储，避免化学腐蚀、渗水受潮损坏设备精密磁路、光学、电路组件。
长期闲置设备定期保养存储标准：设备停用闲置时长超过 7 天，整机完整套上原厂专用防尘罩隔绝粉尘、水汽；每周固定时段接通整机总电源空载运行 10–15 分钟，启动散热循环散热系统循环驱离主机、线圈、管路内部积聚潮气；每月使用稀释医用消毒无尘抹布轻柔擦拭线圈外壳、定位帽接触面、机械臂支架表面，清除堆积粉尘，防止粉尘长期附着腐蚀金属组件、堵塞线圈散热风道、遮挡定位辅助标识。
物流转运临时仓储标准：设备长途物流运输、中转临时仓储阶段，整机全套包裹加厚防震泡沫、密封防潮防护包装箱；全程防护避免雨水浸泡、露天阳光暴晒、剧烈颠簸撞击、重型货物堆叠挤压主机与线圈精密磁路组件；中转临时仓库必须严格执行上述全部温湿度、避光、洁净分区存储标准，中转仓储时长不可超过 30 天，超时需每周通电驱潮保养。
以上产品详情仅供参考，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. Shanghai Kangshida Medical Devices Co., Ltd. does not manufacture medical products. All products are sourced from respective manufacturers, agents and distributors. Please contact us in case of any infringement, and we will handle it promptly.
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