伟思磁刺激仪MagNeuro ONE X280
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产品名称 磁刺激仪
管理类别 第二类
型号规格 MagNeuro ONE X280、MagNeuro ONE X270、MagNeuro ONE X180、MagNeuro ONE X170
结构及组成/主要组成成分 由刺激主机，散热主机，触控一体机，刺激线圈，运动诱发电位检查模块（含电极线、连接线）、TrackONE头盔随动定位系统（含连接线）、磁刺激仪MN系列软件、脚踏开关（选配），一次性使用心电电极（选配）、理疗用体表电极（选配）组成。其中一次性使用心电电极、理疗用体表电极为外购件，持有医疗器械注册证或医疗备案凭证。
适用范围/预期用途 用于人体中枢神经刺激和外周神经刺激，可用于神经电生理检查、康复科神经功能评定和神经科运动功能评定及治疗研究。在医生指导下使用。
一、工作原理 Working Principle
中文
设备储能电容释放瞬时高压交变脉冲电流，传导至专用刺激线圈，依据法拉第电磁感应定律生成快速变化的高强度脉冲磁场。磁场可无衰减穿透衣物、头皮、颅骨、外周软组织，直达大脑皮层或外周神经靶点；时变磁场在人体导电神经组织内部感应内生微电流，改变神经元细胞膜电位，引发去极化，调控神经细胞兴奋性。
经颅神经调控机制：高频（≥10Hz）脉冲提升大脑皮层神经元兴奋性；低频（≤1Hz）脉冲抑制皮层过度兴奋；搭配 TBSθ 爆发刺激、成对脉冲模式，重塑大脑神经突触可塑性，平衡双侧脑区兴奋抑制状态。
外周神经修复机制：脉冲磁场刺激外周运动 / 感觉神经，诱发肌肉节律性收缩，促进局部微循环，抑制异常痉挛信号传导，加速受损神经轴突修复再生。
MEP 神经评定机制：配套无线运动诱发电位（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（MT），量化神经传导功能，实现疗效客观监测。
机器人定位靶向机制：TrackONE 头盔随动导航系统结合 MRI 三维影像重建，光学 + 激光立体定位，锁定脑内靶点，治疗全程线圈动态跟随头部位移，保证磁场能量稳定作用于靶区。
English
The energy storage capacitor of the device releases instantaneous high-voltage alternating pulse current to dedicated stimulation coils, generating rapidly changing high-intensity 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.
Transcranial Neuromodulation Mechanism: High-frequency pulses (≥10Hz) enhance excitability of cerebral cortical neurons; low-frequency pulses (≤1Hz) suppress excessive cortical excitation. Combined with TBS theta burst stimulation and paired pulse modes, it remodels brain synaptic plasticity and balances excitation-inhibition status of bilateral brain regions.
Peripheral Nerve Repair Mechanism: Pulsed magnetic field stimulates peripheral motor/sensory nerves to induce rhythmic muscle contraction, boost local microcirculation, inhibit abnormal spasm signal transmission, and accelerate repair and regeneration of damaged nerve axons.
MEP Nerve Assessment Mechanism: Matched wireless Motor Evoked Potential (MEP) module captures muscle electrical signals induced by stimulation, automatically calculates resting Motor Threshold (MT), quantifies nerve conduction function, and realizes ｏbjective efficacy monitoring.
Robot Targeting Mechanism: TrackONE helmet follow-up navigation system combined with 3D MRI image reconstruction adopts optical & laser stereotaxic positioning to accurately lock intracranial targets. The coil dynamically follows head displacement during treatment to ensure stable magnetic energy acting on target areas.
二、产品功能 Product Functions
中文
全模式脉冲输出系统：支持单脉冲、重复 rTMS、TBSθ 爆发、成对脉冲四种核心刺激模式；频率 0.01–100Hz 连续可调，低频段最小步进 0.1Hz，适配精神科、神经康复全临床方案。
MRI 机器人三维导航：内置医学影像处理模块，3 分钟重建患者个体化 3D 头部模型；万向机器人机械臂，光学激光双重定位，定位精度≤1mm；自动记忆靶点坐标，多次治疗定位无偏差；盔式随动系统实时跟随头部晃动，靶点不偏移。
无线 MEP 运动诱发电位检测：双通道无线 MEP 采集模块，AI 自动识别诱发电位波形，3 分钟完成运动阈值自动测算；实时监测神经传导幅度、潜伏期，客观量化神经损伤程度，用于治疗方案个体化校准与疗效随访评估。
多规格线圈模块化拓展：标配 8 字聚焦线圈，可选成人 / 儿童圆形线圈、深部刺激线圈（刺激深度 6cm）、外周神经专用线圈；线圈支持热插拔，10 秒快速更换；线圈自带实体按键，单手调节刺激强度、一键触发脉冲，便捷完成阈值检测山东省政府...。
专家标准化处方库：内置上百套循证医学标准化治疗方案，覆盖抑郁症、强迫症、脑卒中、脑外伤、帕金森、失眠、痉挛等病种；每套处方配套大脑 3D 解剖定位示意图与文字操作指引，一键启动自动治疗；支持医护自定义存储个性化方案陕西省政府...。
21 寸高清旋转触控交互终端：21 英寸可 260° 旋转触控一体机，参数可视化设置，治疗剩余时长、脉冲总数、实时磁场强度全程大屏展示；操作逻辑简洁，医护快速上手。
数字化全流程病例管理系统：自动存储患者基础信息、头部 3D 影像、历次运动阈值、全部治疗参数、疗效随访记录；支持病例快速检索、治疗数据导出、标准化疗效报告打印；内置数据备份还原功能，防止数据丢失洛阳高新区...。
变频密闭液冷散热系统：刺激线圈搭载密闭变频液冷循环散热结构，连续 30 分钟治疗线圈表面温升≤1℃；线圈表面温度≥40.5℃自动停机声光报警，杜绝高温烫伤风险，支持门诊全天不间断高负荷治疗。
全维度安全防护监测体系：集成线圈脱落、过流、过压、超温、磁场过载、脉冲异常实时监测；刺激强度梯度淡入淡出，升降强度平缓无突发强刺激；具备癫痫预警保护，异常即刻切断输出并声光报警。
静音一体化移动推车整机：整机集成静音万向脚轮，机器人机械臂多维度升降、旋转、前后平移调节，适配不同身高、年龄、头型患者；整机转运便捷，诊室灵活摆放布局。
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 in low-frequency range, compatible with all clinical protocols for psychiatry and neurological rehabilitation.
3D Precise MRI Robot Navigation: Built-in medical image processing module reconstructs individualized 3D head model of patients within 3 minutes. Omni-directional robot arm adopts dual optical & laser positioning with positioning accuracy ≤1mm; automatically memorizes target coordinates to guarantee consistent positioning in repeated treatments. Helmet follow-up system tracks head shaking in real time to avoid target offset.
Wireless MEP Motor Evoked Potential Detection: Dual-channel wireless MEP acquisition module uses AI to automatically identify evoked potential waveｆorms and complete automatic motor threshold measurement within 3 minutes. It monitors nerve conduction amplitude and latency in real time to ｏbjectively quantify nerve injury for individualized protocol calibration and follow-up efficacy evaluation.
Modular Expansion of Multi-Specification Coils: Standard equipped with figure-8 focusing coil; optional adult/children circular coil, deep stimulation coil (6cm penetration depth) and dedicated peripheral nerve coil. Coils support hot-swap and can be replaced within 10 seconds. Physical keys on coils allow one-hand intensity adjustment and one-click pulse trigger for convenient threshold testing山东省政府....
Standardized Expert Preｓcription Library: Built-in hundreds of evidence-based standardized therapeutic protocols covering depression, obsessive-compulsive disorder, stroke, traumatic brain injury, Parkinson’s disease, insomnia, spasticity and other diseases. Each preｓcription is matched with 3D brain anatomical positioning diagrams and textual operation guides, one-click to start automatic therapy. Medical staff can store customized personalized protocols.
21-inch Rotatable HD Touch Interactive Terminal: 21-inch touch all-in-one machine rotatable by 260°, with visual parameter setting. Remaining treatment time, total pulse count and real-time magnetic field intensity are displayed on screen throughout therapy with simple operation logic for fast staff proficiency.
Digital Full-Process Case Management System: Automatically stores patients’ basic inｆormation, 3D head images, historical motor thresholds, all therapy parameters and follow-up efficacy records. It supports rapid case retrieval, therapy data export and printing of standardized efficacy reports; built-in data backup and restore function prevents medical record loss洛阳高新区....
Variable-Frequency Sealed Liquid Cooling Long-Duration Heat Dissipation System: Stimulation coils adopt sealed variable-frequency circulating liquid cooling structure, surface temperature rise ≤1℃ after 30 consecutive minutes of treatment. The device automatically shuts down with audio-visual alarm when coil surface temperature ≥40.5℃ to eliminate high-temperature scald risk and support all-day uninterrupted high-load clinical therapy.
Multi-Dimensional Full-Range Safety Protection Monitoring System: Integrated real-time monitoring for coil detachment, overcurrent, overvoltage, overtemperature, magnetic overload and abnormal pulses. Stimulation intensity fades in and out gradually without sudden strong stimulation; equipped with epilepsy early warning protection to cut off output immediately with audio-visual alarm upon abnormality.
Integrated Silent Mobile Trolley Main Unit: The whole unit is equipped with silent universal casters. The robot mechanical arm supports multi-dimensional lifting, rotation and forward/backward translation adjustment to adapt to patients of different heights, ages and head shapes. The equipment is convenient to transfer and flexibly arranged 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，不直接接触人体皮肤；无一次性电极贴片耗材，线圈可重复消毒长期使用，杜绝患者间交叉感染，皮肤敏感人群适配度高。
MRI 机器人 1mm 级立体靶向：光学 + 激光双定位导航系统，结合个体化头颅三维影像重建，靶点定位误差≤1mm；盔式动态随动结构，患者轻微头部晃动不改变刺激靶点，保证每次治疗能量作用病变脑区，疗效稳定可控。
全刺激模式全覆盖，满足多科室临床需求：同时具备单脉冲、rTMS 重复经颅磁、TBSθ 爆发、成对脉冲四大临床核心模式，频率覆盖 0.01–100Hz，兼顾精神科抑郁焦虑、康复科脑卒中痉挛、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。
无线 MEP 一体化神经功能客观评估：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，量化神经传导损伤程度，解决传统仅凭主观判断疗效的弊端，实现治疗方案个体化校准。
密闭液冷散热，支持全天不间断临床：区别于普通风冷设备，线圈内置变频密闭循环液冷系统，长时间高功率输出无明显温升，超温自动停机保护；适配三甲医院、康复中心、精神专科医院高客流全天连续治疗场景。
模块化多线圈快速更换，一机多用：全套适配聚焦 8 字、圆形、深部、外周四类专用线圈，覆盖大脑浅层、深部皮层、四肢外周神经、盆底神经多部位刺激；线圈支持热插拔，10 秒完成线圈更换，无需排空冷却液，医护单人即可操作。
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，升降强度平缓淡入淡出，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、抽搐、心慌等不良反应发生率。
百万级循证专家处方库，上手零门槛：内置经过临床验证的标准化治疗方案，每种疾病配套专属脑部定位示意图、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，新手快速上手。
完整数字化管理，适配医院信息化系统：全流程自动存储患者影像、阈值、治疗记录，支持数据导出、打印、备份；可对接医院 HIS、LIS 信息化系统，实现患者诊疗数据院内互通，满足三甲医院病案管理规范要求。
医用级多重安全防护，临床使用风险极低：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，具备完整 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 skin. No disposable electrode patch consumables; coils can be repeatedly disinfected for long-term use to eliminate cross-infection between patients, with high adaptability for people with sensitive skin.
1mm-Level Precise Stereotaxic Targeting with MRI Robot: Industry-leading dual optical & laser positioning navigation system combined with individualized 3D cranial image reconstruction achieves target positioning error ≤1mm. Dynamic helmet follow-up structure ensures slight head shaking of patients will not shift stimulation targets, guaranteeing accurate energy delivery to lesioned brain areas for stable and controllable efficacy.
Full Coverage of Stimulation Modes to Meet Clinical Demands of Multiple Departments: Equipped with four core clinical modes simultaneously: single pulse, rTMS repetitive transcranial magnetic stimulation, TBS theta burst and paired pulse. Frequency ranges 0.01–100Hz, covering treatment and neuroelectrophysiological assessment for all diseases including depression/anxiety in psychiatry, stroke spasticity in rehabilitation, Parkinson’s disease in neurology and peripheral nerve injury.
Integrated Wireless MEP Objective Nerve Function Assessment: No external wired electrodes required. Dual-channel wireless acquisition of motor evoked potentials with fully automatic AI motor threshold measurement quantifies nerve conduction injury, eliminating drawbacks of traditional subjective efficacy judgment and enabling individualized precise calibration of therapeutic protocols.
Sealed Liquid Cooling Long-Duration Heat Dissipation for All-Day Uninterrupted Clinical Use: Different from ordinary air-cooled equipment, coils adopt built-in variable-frequency sealed circulating liquid cooling system without obvious temperature rise during long-time high-power output, with automatic shutdown protection upon overtemperature. Suitable for all-day continuous high-flow treatment scenarios in Grade A tertiary hospitals, rehabilitation centers and psychiatric hospitals.
Modular Multi-Coil Quick Replacement, One Device for Multiple Purposes: Fully compatible with four types of dedicated coils: focusing figure-8, circular, deep penetration and peripheral coils, covering stimulation of superficial/deep cerebral cortex, peripheral limb nerves and pelvic floor nerves. Coils support hot-swap and can be replaced within 10 seconds without draining coolant, operable by single medical staff.
Intelligent Gradient Intensity Adjustment for High Patient Comfort: Magnetic field intensity is stepless continuously adjustable from 0–200% motor threshold, with gentle fade-in and fade-out 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, convulsions and palpitations.
Million-Level Evidence-Based Expert Preｓcription Library with Zero Learning Barrier: Built-in clinically verified standardized therapeutic protocols, each disease matched with exclusive brain positioning diagrams, 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 for fast novice proficiency.
Complete Digital Medical Record Management Compatible with Hospital Inｆormation Systems: Automatically stores patient images, motor thresholds and treatment records throughout the whole process, supporting data export, printing and backup. It can connect with hospital HIS and LIS inｆormation systems to realize in-hospital sharing of patient diagnosis and treatment data, complying with medical record management specifications of tertiary hospitals.
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 upon abnormal stimulation with synchronous audio-visual alarm. 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：MagNeuro ONE X280
医疗器械注册证：苏械注准 20242090173
设备整机组成：刺激主机、变频液冷散热主机、21 寸旋转触控一体机、多规格刺激线圈、TrackONE 头盔机器人随动定位系统、无线双通道 MEP 运动诱发电位模块、MN 系列磁刺激仪控制软件、静音移动推车、脚踏开关（选配）、一次性心电电极（选配）。
核心刺激模式：单脉冲、rTMS 重复磁刺激、TBSθ 爆发刺激、成对脉冲刺激
磁场最大磁感应强度：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
脉冲波形基础指标：脉冲上升时间 50µs±10µs；脉冲持续脉宽 340µs±20µs；磁感应强度变化率 40kT/s~80kT/s
治疗时长设置范围：单次刺激串时长 0.1–60s，串间歇间隔 0–90s；总单次治疗时长 1–60 分钟自由设定
线圈散热系统：密闭变频循环液冷散热；线圈表面温度≥40.5℃自动停机声光报警，连续 30min 治疗线圈温升≤1℃
机器人导航定位参数：光学 + 激光立体双重定位，靶点定位精度≤1mm；支持 3D MRI 影像重建，3 分钟生成个体化患者头颅模型；盔式头部动态随动跟随，0ms 延迟实时追踪头部位移
MEP 运动诱发电位模块参数：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：21 英寸高清电容触控一体机，屏幕 260° 旋转调节，可视化参数操作界面
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: MagNeuro ONE X280
Medical Device Registration Certificate: Su Xie Zhu Zhun 20242090173
Whole Unit Composition: Stimulation main unit, variable-frequency liquid cooling heat dissipation main unit, 21-inch rotatable touch all-in-one machine, multi-specification stimulation coils, TrackONE helmet robot follow-up positioning system, wireless dual-channel MEP motor evoked potential module, MN series magnetic stimulator control software, silent mobile trolley, foot switch (optional), disposable ECG electrodes (optional).
Core Stimulation Modes: Single pulse, rTMS repetitive magnetic stimulation, TBS theta burst stimulation, paired pulse stimulation
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
Basic Pulse Waveｆorm Indicators: Pulse rise time 50µs±10µs; pulse duration (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: Sealed variable-frequency circulating liquid cooling; automatic shutdown with audio-visual alarm when coil surface temperature ≥40.5℃, coil temperature rise ≤1℃ after 30 consecutive minutes of treatment
Robot Navigation Positioning Parameters: Dual optical & laser stereotaxic positioning with target positioning accuracy ≤1mm; supports 3D MRI image reconstruction to generate individualized patient cranial model within 3 minutes; dynamic helmet head follow-up tracking head displacement in real time with 0ms delay
MEP Motor Evoked Potential 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: 21-inch HD capacitive touch all-in-one machine with 260° screen rotation adjustment and visual parameter operation interface
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）治疗前整机自检与准备
设备通电自检：连接医用 AC220V 电源，打开主机、液冷散热系统总电源，触控一体机自动启动；设备自动完成电路、液冷循环、线圈通道、MEP 模块、机器人导航定位系统全维度自检，无故障跳转主操作界面；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：确认患者体内无金属磁性植入物、无癫痫病史、无颅内出血 / 重度颅脑损伤、非孕期；头部无新鲜伤口、皮肤破溃、肿瘤病灶。 ② 告知治疗原理，治疗前嘱患者摘除头部金属饰品、金属发卡、眼镜、手机等磁性金属物品；患者可正常穿着棉质衣物，无需脱衣。 ③ 嘱患者排空膀胱，治疗全程保持静坐放松状态，禁止大幅度头部晃动、起身走动。
线圈与导航系统安装调试： ① 根据治疗部位选择匹配线圈（前额叶抑郁选 8 字聚焦线圈，外周神经损伤选外周线圈），线圈热插拔接入主机输出端口，锁紧扣固定。 ② 安装 TrackONE 头盔定位系统，患者佩戴定位头盔，录入患者基础信息，导入患者 MRI 头部影像（无 MRI 可使用标准 3D 头颅模板），软件 3 分钟自动重建个体化 3D 头模。 ③ 操作机器人机械臂，光学激光定位靶点（如左侧 DLPFC 前额叶），系统自动记忆靶点三维坐标，校准线圈与头皮间距，完成定位校准。
治疗处方参数设置：医护在触控屏根据患者病种、病程、运动阈值选择配套标准化专家处方；系统自动匹配标准频率、脉冲串时长、间歇、总治疗时长；初次治疗磁场强度从 30–50% MT 低强度起步，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监测
再次复核患者定位、线圈安装、参数设置无误，点击屏幕「启动治疗」，液冷散热系统同步启动循环制冷，设备线圈按照预设参数输出脉冲磁场。
机器人头盔随动监测：治疗全程盔式定位系统实时捕捉患者头部位移，机械臂动态跟随头部轻微晃动，靶点磁场持续覆盖靶脑区；若患者头部大幅度偏移，屏幕弹窗提示调整体位，暂停脉冲输出。
MEP 实时监测（评定环节）：若需同步神经功能评定，开启无线 MEP 采集模块，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，数据实时同步存储至患者电子。
治疗强度动态调节：治疗过程中持续询问患者头部感受，若患者出现头晕、头胀、轻微抽搐、心慌不适感，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，可平缓梯度小幅提升强度，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、肢体状态；设备实时监测线圈温度、电流、磁场输出，线圈温度接近 40℃自动降低输出功率，超温直接停机声光报警；若患者突发全身抽搐、意识模糊，立即切断设备电源，开展应急处置。
（三）治疗结束收尾流程
预设总治疗时长全部完成后，设备自动停止脉冲磁场输出，液冷散热系统延时 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、靶点坐标、MEP 运动阈值、患者耐受记录，归入患者专属电子档案；医护可按需调取历史治疗记录，打印标准化疗效随访报告。
患者离场与线圈消毒：患者缓慢摘下定位头盔，起身离场；医护取下刺激线圈，使用医用季铵盐稀释消毒液轻柔擦拭线圈外壳、头盔接触面、机械臂支架；擦拭后通风静置至消毒剂完全风干，避免消毒液残留腐蚀线圈绝缘层。
设备闲置维护收纳： ① 当日间断使用：关闭触控显示屏，主机与液冷系统保持通电待机状态，维持液冷循环低温，便于下一位患者快速启动治疗。 ② 每日治疗全部结束：依次关闭机器人定位系统、MEP 模块、液冷散热主机、刺激主机总电源；将机械臂线圈支架收回归零，整机覆盖防尘罩；每日通电空载运行 10 分钟，驱散液冷管路内部潮气，保护磁路精密组件。 ③ 长期闲置超过 7 天：断开设备总供电电源，排空液冷系统冷却液，线圈、头盔配件单独分区收纳存放，整机完整套防尘罩；每周固定时间通电空载运行 15 分钟驱潮保养。
English
(1) Pre-Treatment Full-Unit Self-Test & Preparation
Equipment power-on self-test: Connect medical AC220V power supply and turn on main power switches of stimulation main unit and liquid cooling heat dissipation system. The touch all-in-one machine starts automatically. The equipment completes full-dimensional self-test of circuits, liquid cooling circulation, coil channels, MEP module and robot navigation positioning system automatically. It jumps to the 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 ｍmbedl/magnetic implants, no epilepsy history, no intracranial hemorrhage/severe craniocerebral injury and are non-pregnant; no fresh wounds, broken skin or tumor lesions on the head. ② Explain non-invasive therapy principle. Instruct patients to remove all magnetic and ｍmbedl items on the head before therapy, including ｍmbedl hair clips, glasses and mobile phones. Patients can wear normal cotton clothing without undressing. ③ Advise patients to empty the bladder and maintain a sitting relaxed state throughout therapy; large-scale head shaking and walking around are prohibited.
Coil & Navigation System Installation & Debugging: ① Select matched coil according to treatment site (figure-8 focusing coil for prefrontal lobe depression, peripheral coil for peripheral nerve injury). Hot-swap the coil into the main unit output port and fasten the lock buckle. ② Install TrackONE helmet positioning system. Patients wear the positioning helmet, input patient basic inｆormation and import patient MRI head images (standard 3D cranial template can be used without MRI). The software automatically reconstructs individualized 3D head model within 3 minutes. ③ Operate the robot mechanical arm and position the target via optical laser (e.g., left DLPFC prefrontal lobe). The system automatically memorizes 3D target coordinates, calibrates the distance between coil and scalp and completes positioning calibration.
Therapeutic Preｓcription Parameter Setting: Medical staff select matched standardized expert preｓcriptions on the touch screen according to patient disease type, disease course and motor threshold. The system automatically matches standard frequency, pulse 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 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 & Monitoring
Double-check patient positioning, coil installation and parameter settings for accuracy, then click "Start Therapy" on screen. The liquid cooling heat dissipation system starts circulating refrigeration synchronously, and the equipment coil outputs pulsed magnetic field according to preset parameters.
Robot helmet follow-up monitoring: The helmet positioning system captures patient head displacement in real time throughout therapy, and the mechanical arm dynamically follows slight head shaking to keep target brain area fully covered by magnetic field. If the patient’s head shifts drastically, a pop-up window prompts posture adjustment and pulse output pauses temporarily.
Real-Time MEP Monitoring (Assessment Stage): If synchronous nerve function assessment is required, enable the wireless MEP acquisition module and attach 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 data is synchronized and stored into the patient’s electronic medical record instantly.
Dynamic Therapy Intensity Adjustment: Continuously inquire about the patient’s head sensation during therapy. If the patient experiences dizziness, head distension, slight convulsions or palpitations, 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 and limb status. The equipment monitors coil temperature, current and magnetic field output in real time. The output power is automatically reduced when coil temperature approaches 40℃, and the equipment shuts down with audio-visual alarm directly upon overtemperature. If the patient suffers sudden general convulsions or confusion, cut off the equipment power supply immediately and carry out emergency disposal.
(3) Post-Treatment Closing Procedures
After completion of preset total therapy duration, the equipment automatically stops pulsed magnetic field output. The liquid cooling 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 coordinates, MEP motor thresholds and patient tolerance records of this session into the patient’s exclusive electronic medical record file. Medical staff can retrieve historical therapy records and print standardized efficacy follow-up reports as needed.
Patient departure and coil disinfection: Patients slowly take off the positioning helmet and leave. Medical staff remove the stimulation coil and gently wipe the coil housing, helmet contact surfaces and mechanical arm brackets with medical diluted quaternary ammonium salt disinfectant. Ventilate and stand still until the disinfectant air-dries completely after wiping to avoid residual disinfectant corroding the coil insulating ｌayer.
Idle Equipment Maintenance & Storage: ① Intermittent daily use: Turn off the touch display screen, keep the main unit and liquid cooling system powered on standby to maintain low-temperature liquid cooling circulation for fast therapy startup for subsequent patients. ② End of daily all therapy sessions: Turn off the robot positioning system, MEP module, liquid cooling heat dissipation main unit and stimulation main unit main power supply in sequence. Retract and reset the mechanical arm coil bracket, cover the whole unit with a dust-proof cover. Power on and run no-load for 10 minutes every day to dispel internal moisture in liquid cooling pipelines and protect precision magnetic circuit components. ③ Long-term idle over 7 days: Cut off the main power supply of the equipment, drain coolant from the liquid cooling system, store coils and helmet accessories separately in partitioned storage areas and fully cover the whole unit with a dust-proof cover. Power on and run no-load for 15 minutes at fixed time every week for moisture removal maintenance.
六、适应症 Indications
中文
依据医疗器械注册证官方适用范围：用于人体中枢神经刺激和外周神经刺激，可用于神经电生理检查、康复科神经功能评定和神经科运动功能评定及治疗研究；配合药物，进行神经疾病引起的失眠、精神类症状的辅助治疗，全程需在执业医师指导下使用。 细分临床适配病症：
精神科适应症：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）。
神经内科康复适应症：脑卒中（脑出血、脑梗死）后遗症、脑外伤后运动功能障碍、帕金森病运动迟缓与肌张力增高、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。
神经痉挛类病症：脑卒中、脑外伤后肢体痉挛、肌张力异常增高，改善肢体活动受限、关节挛缩。
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、局部肢体麻木、感觉减退。
神经电生理评定用途：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、康复疗效客观随访对比。
English
Official intended use per medical device registration certificate: For human central nervous system stimulation and peripheral nervous system stimulation; applicable to neuroelectrophysiological examination, neurological function evaluation in rehabilitation department, motor function evaluation, treatment and research in neurology department. Combined with medication, it serves as adjuvant therapy for insomnia and psychiatric symptoms caused by neurological diseases. All operations must be conducted under the guidance of licensed physicians. Subdivided clinically applicable diseases:
Psychiatric 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).
Neurological Rehabilitation Indications: Sequelae of stroke (cerebral hemorrhage, cerebral infarction), motor dysfunction after traumatic brain injury, bradykinesia and increased muscle tension of Parkinson’s disease, neurological deficits of multiple sclerosis, motor/urination/defecation dysfunction after spinal cord injury.
Neural Spasm Diseases: Limb spasm and abnormally increased muscle tension after stroke and traumatic brain injury, to improve limited limb movement and joint contracture.
Peripheral Nerve Injury Indications: Entrapment and injury of limb peripheral nerves including ulnar nerve, radial nerve and common peroneal nerve; neurogenic muscular atrophy, local limb numbness and hypoesthesia.
Neuroelectrophysiological Assessment Application: 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 and ｏbjective follow-up comparison of rehabilitation efficacy.
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）
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。
颅内存在金属异物、颅内肿瘤病灶、近期（3 个月内）颅内出血、重度未康复颅脑损伤、颅内高压、脑积水急性期。
确诊癫痫、有明确全身抽搐、惊厥发作病史人群（磁刺激存在诱发癫痫发作风险）。
治疗区域头部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。
妊娠期女性（全孕期禁止头部经颅磁刺激，磁场可能影响胎儿神经发育）。
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。
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。
严重恶性肿瘤晚期、全身广泛多发肿瘤转移患者。
相对禁忌症（必须经执业医师风险评估，全程严密心电、意识监护，低强度谨慎短时治疗）
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、严重心律失常未控制人群。
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。
精神躁动、躁狂发作、认知障碍无法长时间静坐配合头部定位治疗的患者。
头部皮肤重度感觉减退、麻木，无法自主感知磁场刺激强度，无法及时反馈头晕、刺痛等不适症状人群。
急性颅内感染、脑膜炎、脑炎急性期伴随剧烈头痛、高热患者，需炎症完全后再开展磁刺激治疗。
肝肾功能重度衰竭、重度电解质紊乱未纠正人群。
儿童、高龄 75 岁以上老年患者，神经耐受度弱，需大幅降低刺激强度、缩短单次治疗时长。
English
Absolute Contraindications (Magnetic stimulation therapy with this equipment is strictly prohibited)
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 ｍmbedl foreign bodies, intracranial tumor lesions, recent intracranial hemorrhage (within 3 months), unrecovered severe craniocerebral injury, intracranial hypertension and acute hydrocephalus.
Confirmed epilepsy or medical history of generalized convulsions and seizures (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 (transcranial magnetic stimulation on the head is prohibited throughout gestation; magnetic field may affect fetal neural development).
Patients with severe coagulation disorders, active intracranial/systemic massive hemorrhage or uncontrolled hemophilia.
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.
Patients with advanced severe malignant tumors and extensive systemic multiple tumor ｍmbedstases.
Relative Contraindications (Comprehensive risk assessment by licensed physicians is mandatory; continuous close cardiac and consciousness monitoring throughout therapy, cautious short-duration low-intensity treatment only)
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.
Agitated, manic or cognitively impaired patients unable to sit still for a long time and cooperate with head positioning therapy.
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 acute intracranial infection, meningitis or encephalitis in acute phase accompanied by severe headache and high fever; magnetic stimulation therapy can only be carried out after complete cure of inflammation.
Crowds with severe liver and kidney failure or uncorrected severe electrolyte disorders.
Children and elderly patients over 75 years old with weak nerve tolerance; stimulation intensity must be greatly reduced and single therapy duration shortened significantly.
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：严格检查患者头部、全身所有金属、磁性物品，严禁携带手机、金属发卡、项链、眼镜、助听器等进入磁场刺激区域；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；磁场穿透性强，近距离刺激上述敏感脏器易引发不适、功能损伤。
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。
设备运行中禁止热插拔线圈、拆卸头盔定位系统、拆解主机、液冷散热机组外壳；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，等待液冷系统停止循环后再拆装操作。
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、线圈超温频繁自动停机、机器人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、液冷管路组件，时间联系厂家专业售后工程师上门维修。
（二）患者临床全程监护规范
治疗全程医护不得脱岗离岗，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；重点监测是否出现头晕、恶心呕吐、剧烈头部胀痛、肢体不自主抽搐、胸闷心慌、视物模糊等不良症状。
突发不适标准化应急处理：治疗中患者突发眩晕、剧烈头痛、全身发麻、肢体抽搐、意识恍惚，医护立即点击屏幕停机，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；若抽搐持续超过 1 分钟、意识丧失，立即启动院内急救流程，呼叫急诊科、神经内科医师会诊处置。
特殊人群专项监护细则：孕妇绝对禁用；65 岁以上老人、儿童、高血压、冠心病、脑梗后遗症、帕金森、重度焦虑抑郁患者，全程采用低强度刺激方案，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，出现指标异常即刻终止治疗。
治疗前身体状态管控要求：禁止患者空腹、重度疲劳、大量饮酒、服用兴奋性精神类药物后开展磁刺激治疗；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、能量饮料等刺激性饮品。
（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、定位头盔全部接触面、机器人机械臂、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。
精密线圈、机器人组件养护规范：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；机械臂、激光定位传感器为光学精密器件，禁止用手直接触摸激光镜头，禁止消毒液、水渍溅射到光学传感元件表面，造成定位精度下降、传感器故障。
线缆、液冷管路防护要求：线圈连接线、MEP 模块传输线缆、机器人定位信号线避免过度弯折、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配件；液冷循环管路禁止弯折挤压，每年由厂家售后更换专用冷却液，防止管路堵塞、腐蚀渗漏。
整机清洁禁止喷淋水洗规范：刺激主机、液冷机组、触控一体机、机器人机械臂、推车整机严禁直接使用清水喷淋冲洗；日常清洁仅可使用湿润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、液冷管路组件，液体渗漏会造成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、超声大功率电磁医疗设备；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、机器人定位坐标偏移，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、液冷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。
长期闲置设备驱潮保养规范：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，启动液冷循环散热系统驱散主机、线圈、管路内部积聚潮气，保护精密电路、磁路、光学传感组件，避免潮湿腐蚀老化核心配件。
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、头盔、MEP 模块、机械臂光学传感器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. Carrying mobile phones, ｍmbedl hair clips, necklaces, glasses, hearing aids and other items into the magnetic stimulation area is prohibited. Patients with implanted electronic devices are directly forbidden from therapy to avoid magnetic field interference triggering arrhythmia, equipment failure and life-threatening risks.
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 and pelvic reproductive viscera. The magnetic field has strong penetration; close-range stimulation of these sensitive organs easily causes discomfort and functional damage.
Mandatory gradient intensity adjustment: For all initial therapy, elderly, children and patients with underlying cardiovascular and cerebrovascular diseases, 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.
Hot-swap of coils, disassembly of helmet positioning system and dismantling of main unit/liquid cooling unit housing are prohibited during equipment operation. To replace coils or maintain accessories, click stop on screen, cut off the main power supply of the equipment, and wait for the liquid cooling system to stop circulation before disassembly and assembly operations.
Fault emergency disposal procedure: If abnormal phenomena such as strange noise, burnt odor, screen error codes, frequent automatic shutdown due to coil overtemperature and stuck offset of robot 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 liquid cooling pipeline components by themselves; contact professional after-sales engineers of the manufacturer for on-site maintenance as soon as possible.
(2) Full-Process Clinical Patient Monitoring Specifications
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 and blurred vision.
Standardized emergency handling for sudden discomfort: If the patient suffers sudden vertigo, severe headache, general numbness, limb convulsions or confusion during therapy, medical staff shall click stop on screen 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. If convulsions last more than 1 minute or consciousness is lost, activate the hospital emergency procedure immediately and call emergency and neurology physicians for consultation and disposal.
Special monitoring rules for high-risk groups: Pregnant women are absolutely prohibited. For patients over 65 years old, children, hypertension, coronary heart disease, stroke sequelae, Parkinson’s disease and severe anxiety/depression, adopt low-intensity stimulation protocols throughout therapy and 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.
Physical state control requirements before therapy: Magnetic stimulation therapy is prohibited for patients on an empty stomach, severely fatigued, after heavy drinking or taking excitatory psychiatric drugs. 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 and energy drinks is prohibited within 2 hours before therapy.
(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 helmet, robot mechanical arm 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 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.
Maintenance specifications for precision coils and robot components: The interior of stimulation coils consists of high-precision core magnetic circuit components. Rough impact, dropping and heavy extrusion of coils are prohibited. Mechanical arms and laser positioning sensors are optical precision devices; direct hand contact with laser lenses and splashing of disinfectant or water stains on the surface of optical sensing elements are forbidden, which will reduce positioning accuracy and cause sensor failures.
Protection requirements for cables and liquid cooling pipelines: Avoid excessive bending, violent pulling and cutting damage from sharp ｏbjects to coil connecting cables, MEP module transmission cables and robot positioning signal lines. 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 ones. Bending and extrusion of liquid cooling circulating pipelines are prohibited; the manufacturer’s after-sales team shall replace special coolant every year to prevent pipeline blockage, corrosion and leakage.
Whole-unit cleaning prohibition of water spray washing: Direct water spray flushing of stimulation main unit, liquid cooling unit, touch all-in-one machine, robot mechanical arm and trolley whole unit is strictly prohibited. Daily cleaning can only be carried out by gently wiping equipment housing and screen surface with damp disinfection dust-free soft rags. Strictly prevent liquid infiltration into internal circuits, magnetic circuits and liquid cooling pipeline components of the main unit; liquid leakage will cause 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-power electromagnetic medical equipment including high-frequency electrosurgical units, radiofrequency ablation instruments, MRI, CT, X-ray machines and ultrasound machines in the treatment room. Strong electromagnetic interference will disrupt the magnetic field output parameters of this equipment, distort MEP nerve detection data and offset robot positioning coordinates, directly reducing therapy precision and efficacy stability. The minimum safe distance between the equipment and large imaging 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 liquid cooling pipelines causing blockages. Place the equipment far away from hand washing sinks, disinfection spray areas and humid water source zones, and keep the ground dry without water accumulation.
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 a 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 liquid cooling circulating heat dissipation system to dispel accumulated moisture inside the main unit, coils and pipelines, protect precision circuits, magnetic circuits and optical sensing components, and avoid aging and corrosion of core accessories caused by dampness.
Transfer and inter-department mobile protection specifications: During inter-room transfer and long-distance logistics transportation of the equipment, separately wrap coils, helmets, MEP modules and mechanical arm optical sensors 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 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；高温加速液冷冷却液老化变质、线圈绝缘塑胶老化脆裂，大幅缩短整机使用寿命。
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、液冷管路内壁滋生霉菌堵塞循环管路，造成设备故障停机。
避光存储硬性要求：整机、线圈、头盔、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；液冷管路塑胶管材长期光照会加速老化渗漏。
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、液冷管路，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。
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，损坏磁场输出精度，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。
分区隔离存放规范：MagNeuro ONE X280 磁刺激仪刺激主机、液冷散热机组、刺激线圈、定位头盔、MEP 传感模块、配套信号线、机械臂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，启动液冷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、头盔接触面、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、遮挡光学定位传感器镜头。
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。
English
Storage Temperature Standard: The ambient temperature for long-term warehouse storage and idle placement in treatment rooms shall be stably maintained at 5℃ ~ 40℃. Storage in freezing environment below 0℃ or high-temperature sun-exposed environment above 45℃ is prohibited. Low temperature will cause failure and damage of electronic components including internal main unit circuit boards and coil magnetic cores; high temperature accelerates aging and deterioration of liquid cooling coolant and embrittlement cracking of coil insulating plastic, greatly shortening the overall service life of the equipment.
Storage Humidity Standard: The relative ambient humidity of storage warehouses and treatment rooms shall be strictly controlled at 10% ~ 80%. No condensation, water accumulation or water seepage shall exist in the whole storage area. Excessively high ambient humidity will cause damp short circuits of main unit circuit boards, rusting of ｍmbedl mechanical brackets and internal coil ｍmbedl magnetic cores, mold growth inside liquid cooling pipelines blocking circulation pipelines and resulting in equipment failure and shutdown.
Mandatory Light Avoidance Storage Requirements: The whole unit, coils, helmets, touch display screen accessories must be stored away from light, far away from windows with direct sunlight and areas with long-term continuous irradiation of ultraviolet disinfection lamps. Long-term strong light and ultraviolet irradiation will cause aging, embrittlement and cracking of plastic materials of equipment housing, attenuation and aging of touch screen backlight components, reducing screen display clarity and service life. Long-term light exposure accelerates aging and leakage of plastic liquid cooling pipeline tubes.
Storage Area Cleanliness & Gas Isolation Requirements: The warehouse and treatment room areas where the equipment is stored must be kept dry, ventilated, dust-free and clean. Keep separated from storage areas of ｆormaldehyde, high-concentration alcohol, atomized disinfection gas, strong acid and alkali and volatile corrosive chemical reagents. Continuous contact between corrosive volatile gas and equipment ｍmbedl brackets, circuit interfaces, coil magnetic cores and liquid cooling pipelines will cause ｍmbedl oxidation and rust, poor contact of circuit contacts and pipeline corrosion leakage failures.
Stacking Placement Warehouse Specifications: The outer packaging cartons of the whole equipment and accessories must be stored flat horizontally. Inverted placement, tilted side placement and stacking heavy ｏbjects to press and cover the whole equipment and precision coil accessories are strictly prohibited. The high-precision magnetic cores inside coils have extremely poor compression resistance; heavy extrusion will easily cause displacement and deｆormation of magnetic cores, permanently damaging magnetic field output accuracy and rendering the equipment completely incapable of therapeutic functions. The total stacking height of equipment during transportation and warehousing shall not exceed 4 ｌayers.
Zoned Isolation Storage Specifications: The stimulation main unit, liquid cooling heat dissipation unit, stimulation coils, positioning helmet, MEP sensing module, supporting signal lines and mechanical arm accessories of MagNeuro ONE X280 magnetic stimulator must be stored separately in isolated zones. Mixing storage with disinfection chemicals, strong acid and alkali chemical reagents, domestic garbage and damp water-containing sundries is strictly prohibited to avoid chemical corrosion and water seepage dampness damaging precision magnetic circuit, optical and circuit components of the equipment.
Regular Maintenance Storage Standard 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 liquid cooling circulating heat dissipation system to circulate and remove accumulated moisture inside the main unit, coils and pipelines. Wipe the coil housing, helmet contact surfaces and mechanical arm bracket surface gently with diluted medical disinfection dust-free rags every month to remove accumulated dust, preventing long-term dust adhesion from corroding
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