厂家供应伟思磁刺激仪MagBelle F130
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厂家供应伟思磁刺激仪MagBelle F130
桂经理19117326863微xin同号
桂经理19117326863微xin同号
产品名称 磁刺激仪
管理类别 第二类
型号规格 MagBelle F110、MagBelle F120、MagBelle F130、MagBelle F140、MagBelle F150、MagBelle F160、MagBelle F170、MagBelle F180、MagBelle F210、MagBelle F220、MagBelle F230、MagBelle F240、MagBelle F250、MagBelle F260、MagBelle F270、MagBelle F280、MagBelle F310、MagBelle F320、MagBelle F330、MagBelle F340、MagBelle F350、MagBelle F360、MagBelle F370、MagBelle F380、MagBelle R110、MagBelle R120、MagBelle R130、MagBelle R140、MagBelle R150、MagBelle R160、MagBelle R170、MagBelle R180、MagBelle R210、MagBelle R220、 MagBelle R230、MagBelle R240、MagBelle R250、MagBelle R260、MagBelle R270、MagBelle R280
结构及组成/主要组成成分 由主机、座椅、刺激线圈、磁刺激仪MB系列软件、压力套件、运动诱发电位检查模块、理疗用体表电极、阴道电极、一次性使用心电电极、直肠电极、脚踏开关组成。其中理疗用体表电极、阴道电极、一次性使用心电电极、直肠电极为外购件，持有医疗器械注册证或备案凭证。
适用范围/预期用途 刺激人体中枢神经和外周神经，用于中枢神经和外周神经功能的检测、评定、改善，用于神经电生理检查，用于神经损伤性疾病、腰骶神经功能障碍的辅助治疗。
一、工作原理 Working Principle
中文
设备主机产生高压脉冲电流，作用于专用治疗线圈，根据法拉第电磁感应原理，线圈快速交变脉冲磁场穿透人体皮肤、脂肪层，直达盆底肌群、骶 3 神经根深度 4–6cm，在人体深部组织内感应出内生微电流，无表皮电极、无皮肤刺痛、全程。
盆底模式：脉冲磁场同步激活盆底浅层、中层、深层全部肌群，模拟标准凯格尔主动收缩 + 被动放松，修复受损肌纤维、提升盆底肌力与肌肉耐力，改善肌肉神经传导功能。
骶神经调控模式：磁场靶向 S3 骶神经孔，感应电流刺激骶神经束，调控膀胱、直肠、盆底神经反射环路，平衡排尿、排便神经信号传导，缓解神经源性膀胱、肠道功能紊乱。
主被动一体化调控：磁场刺激同时搭配实时坐姿压力传感监测，动态校正刺激位置，保证每次脉冲作用靶组织；搭配运动诱发电位模块，可同步检测神经肌肉电生理反应，量化评估神经损伤程度。
English
The main unit generates high-voltage pulse current and transmits it to the dedicated therapeutic coil. Based on Faraday’s law of electromagnetic induction, the rapidly alternating pulsed magnetic field of the coil penetrates human skin and adipose tissue, reaching a depth of 4–6 cm at the pelvic floor muscles and S3 sacral nerve root. It induces endogenous micro-current in deep human tissues without surface electrodes or skin stinging, fully non-invasive.
Pelvic Floor Mode: The pulsed magnetic field synchronously activates all superficial, middle and deep pelvic floor muscle groups, simulating standard Kegel active contraction and passive relaxation. It repairs damaged muscle fibers, improves pelvic floor muscle strength and endurance, and restores neuromuscular conduction function.
Sacral Neuromodulation Mode: The magnetic field accurately targets the S3 sacral foramen. The induced current stimulates the sacral nerve bundle, modulates the reflex loops of bladder, rectum and pelvic floor nerves, balances neural signal transmission for micturition and defecation, and relieves neurogenic bladder and intestinal dysfunction.
Active-Passive Integrated Regulation: Magnetic stimulation is combined with real-time sitting posture pressure sensor monitoring to dynamically correct the stimulation position and ensure each pulse accurately targets the tissue. Equipped with a motor evoked potential module, it can synchronously detect neuromuscular electrophysiological responses to quantitatively assess the degree of nerve injury.
二、产品功能 Product Functions
中文
双治疗模式切换：盆底康复模式、骶神经调控模式，覆盖泌尿、肛肠、产后全场景康复治疗。
主被动一体化训练：无需阴道 / 直肠侵入电极，患者坐姿 / 俯卧位即可完成盆底肌主动收缩 + 被动节律训练，替代人工凯格尔训练。
实时坐姿压力监测：座椅内置压力传感套件，实时捕捉患者坐姿偏移，动态提示调整体位，保证磁场靶向靶神经 / 肌群，提升治疗。
医患双屏独立交互系统：医生操作主屏、患者副屏分离，医师设置治疗处方、查看病例数据；患者可自主查看治疗进度、耐受强度，医患互不干扰。
全自动标准化治疗流程：内置多套专科专家处方模板（产后康复、压力性尿失禁、急迫性尿失禁、慢性便秘、盆腔疼痛、术后排便障碍），一键启动自动治疗，自动控制刺激频率、脉冲时长、间歇周期、总脉冲次数。
运动诱发电位（MEP）神经检测：配套 2 通道无线电生理采集模块，最小分辨率≤0.1µV，检测盆底、骶神经运动阈值，量化评估神经损伤、肌力分级，用于术前评估、疗效对比复查。
病例数据库管理：自动存储患者基础信息、历次治疗参数、神经检测报告，支持病例检索、数据导出、治疗报告打印。
强度自适应调节：治疗过程中可实时升降刺激输出强度，匹配不同患者疼痛耐受阈值；设备具备过载、过流、过热多重安全保护。
English
Dual Switchable Therapy Modes: Pelvic floor rehabilitation mode and sacral neuromodulation mode, covering rehabilitation scenarios of urology, proctology and postpartum care.
Non-invasive Active-Passive Integrated Training: No invasive vaginal or rectal electrodes required. Patients can complete active contraction and passive rhythmic training of pelvic floor muscles in sitting or prone position, replacing manual Kegel exercises.
Real-time Sitting Posture Pressure Monitoring: Pressure sensor kits built into the seat capture sitting posture offset in real time, dynamically prompt posture adjustment, ensure magnetic field accurately targets target nerves or muscle groups, and improve therapeutic efficiency.
Independent Dual-screen Doctor-Patient Interaction System: Separate main screen for clinicians and secondary screen for patients. Physicians set treatment preｓcriptions and view case data; patients can independently check treatment progress and tolerance intensity without mutual interference.
Fully Automatic Standardized Treatment Workflow: Built-in multiple sets of specialized expert preｓcription templates (postpartum rehabilitation, stress urinary incontinence, urge urinary incontinence, chronic constipation, pelvic pain, postoperative defecation disorders). One-click automatic treatment with automatic control of stimulation frequency, pulse duration, interval cycle and total pulse count.
Motor Evoked Potential (MEP) Nerve Detection: Matched with a 2-channel wireless electrophysiology acquisition module with minimum resolution ≤0.1µV. It accurately detects motor thresholds of pelvic floor and sacral nerves, quantitatively assesses nerve injury and muscle strength grading for preoperative evaluation and efficacy follow-up comparison.
Case Database Management: Automatically stores patients’ basic inｆormation, historical treatment parameters and nerve test reports, supporting case retrieval, data export and printing of treatment reports.
Adaptive Intensity Adjustment: Stimulation output intensity can be increased or decreased in real time during treatment to match pain tolerance thresholds of different patients. The equipment is equipped with multiple safety protections against overload, overcurrent and overheating.
三、产品特点 Product Features
中文
全程非侵入治疗：无需脱裤、无体内侵入电极、无皮肤导电膏、无刺痛不适感，患者接受度高，降低交叉感染风险。
主被动一体化协同刺激：磁场可同时实现被动肌肉放松 + 主动肌纤维收缩，解决患者自主收缩无力、无法完成标准凯格尔的问题，疗效优于单一电刺激。
专用多功能治疗座椅：座椅靠背角度 0–180° 无级可调，支持坐姿盆底治疗、俯卧位骶神经 S3 靶向治疗；座椅内置压力传感监测模块，实时校准刺激位置。
主副双屏分离设计：医师操作大屏、患者独立小屏，医患操作互不干扰，提升诊室诊疗效率。
高运动诱发电位检测模块：无线 2 通道采集，分辨率≤0.1µV，可客观量化神经损伤程度，实现可量化、可对比的康复疗效评估。
全自动智能处方系统：内置数十套临床验证专家治疗方案，一键启动标准化治疗，减少人工参数设置误差。
安全多重防护机制：设备内置过热、过流、短路、线圈故障实时监测，异常自动停机声光报警；刺激强度分级平缓调节，避免突发强刺激造成不适。
整机一体化可移动推车：主机带静音万向轮，线圈支架多角度调节，适配不同身高、体型患者；线圈支持热插拔更换，维护便捷。
无耗材长期使用：治疗线圈、座椅可重复使用，无需一次性电极耗材，长期使用运营成本更低。
合规二类医用设备：符合国家 NMPA 医疗器械标准，适用于医院妇产科、康复科、泌尿外科、肛肠科、产后康复中心。
English
Fully Non-invasive Therapy: No need to remove clothing, no internal invasive electrodes, no skin conductive gel, no stinging discomfort. High patient acceptance and reduced risk of cross-infection.
Active-Passive Integrated Synergistic Stimulation: The magnetic field simultaneously achieves passive muscle relaxation and active muscle fiber contraction, solving the problem of weak voluntary contraction and inability to complete standard Kegel exercises. The efficacy is superior to single electrical stimulation.
Special Multifunctional Therapeutic Seat: The backrest angle is steplessly adjustable from 0 to 180°, supporting sitting pelvic floor treatment and prone S3-targeted sacral nerve treatment. A built-in pressure sensor monitoring module calibrates the stimulation position in real time.
Separate Dual-screen Design: Large operation screen for clinicians and independent small screen for patients, eliminating mutual interference and improving clinic efficiency.
High-precision Motor Evoked Potential Detection Module: Wireless 2-channel acquisition with resolution ≤0.1µV, which can ｏbjectively quantify the degree of nerve injury and realize quantifiable and comparable rehabilitation efficacy evaluation.
Fully Automatic Intelligent Preｓcription System: Built-in dozens of clinically verified expert treatment protocols with one-click standardized treatment startup to reduce manual parameter setting errors.
Multi-ｌayer Safety Protection Mechanism: The equipment is equipped with real-time monitoring for overheating, overcurrent, short circuit and coil faults. It automatically shuts down with audio-visual alarms in case of abnormalities. Stimulation intensity is adjusted gently in grades to avoid discomfort caused by sudden strong stimulation.
Integrated Mobile Trolley for Complete Unit: The main unit is equipped with silent universal casters, and the coil bracket can be adjusted at multiple angles to adapt to patients of different heights and body types. The coil supports hot-swap replacement for convenient maintenance.
Long-term Use Without Consumables: The therapeutic coil and seat are reusable without disposable electrode consumables, resulting in lower long-term operating costs.
Compliant Class II Medical Device: Complies with China NMPA medical device standards, applicable to hospital obstetrics and gynecology, rehabilitation, urology, proctology and postpartum rehabilitation centers.
四、技术参数 Technical Specifications
中文
产品型号：MagBelle F130
医疗器械注册证：苏械注准 20222091563
设备组成：主机、多功能治疗座椅、磁刺激治疗线圈、MB 系列控制软件、压力传感套件、2 通道无线运动诱发电位检测模块、脚踏开关。
治疗模式：盆底康复模式、骶神经调控模式
运动诱发电位模块参数：2 通道无线采集，最小分辨率≤0.1µV，支持神经运动阈值检测、肌力分级评估
座椅调节：靠背 0°–180° 无级可调，适配坐姿、俯卧位两种治疗体位
人机交互：医师主屏 + 患者副屏双独立触控显示屏
刺激参数可调范围
刺激频率：1Hz–50Hz 连续可调
单次脉冲时长：1s–10s
间歇周期：3s–20s
总脉冲次数：100–10000 次自定义设置
单次标准治疗时长：10–30 分钟（临床常规 20 分钟 / 次）
供电电源：AC220V，50Hz 医用标准供电
安全保护：过热、过流、短路、线圈故障自动停机 + 声光报警
灭菌 / 耗材：整机无一次性耗材，可重复使用；线圈、座椅表面可医用消毒剂擦拭消毒
整机存储温湿度：环境温度 5℃–40℃，相对湿度 10%–80%，无凝露
适用科室：妇产科、产后康复中心、泌尿外科、肛肠科、康复医学科
English
Model Number: MagBelle F130
Medical Device Registration Certificate: Su Xie Zhu Zhun 20222091563
Equipment Composition: Main unit, multifunctional therapeutic seat, magnetic stimulation therapeutic coil, MB series control software, pressure sensor kit, 2-channel wireless motor evoked potential detection module, foot switch.
Therapy Modes: Pelvic floor rehabilitation mode, sacral neuromodulation mode
Motor Evoked Potential Module Specs: 2-channel wireless acquisition, minimum resolution ≤0.1µV, supporting nerve motor threshold detection and muscle strength grading evaluation.
Seat Adjustment: Stepless backrest adjustment from 0° to 180°, compatible with two treatment postures: sitting and prone.
Human-Machine Interaction: Dual independent touch displays: main screen for clinicians, secondary screen for patients.
Adjustable Stimulation Parameter Range
Stimulation frequency: Continuously adjustable 1Hz–50Hz
Single pulse duration: 1s–10s
Interval cycle: 3s–20s
Total pulse count: Customizable 100–10000 pulses
Standard Single Treatment Duration: 10–30 minutes (routine clinical treatment: 20 mins per session)
Power Supply: AC220V, 50Hz medical standard power supply
Safety Protection: Automatic shutdown with audio-visual alarm for overheating, overcurrent, short circuit and coil faults.
Sterilization & Consumables: No disposable consumables for the whole unit, reusable. Surfaces of coils and seats can be wiped and disinfected with medical disinfectants.
Storage Temperature & Humidity for Complete Unit: Ambient temperature 5℃–40℃, relative humidity 10%–80%, no condensation.
Applicable Departments: Obstetrics and Gynecology, Postpartum Rehabilitation Center, Urology, Proctology, Rehabilitation Medicine.
五、使用方法 Operation Procedures
中文
（一）治疗前准备
设备开机自检：接通 220V 医用电源，打开主机电源开关，设备自动整机自检，确认线圈、压力传感、MEP 检测模块无故障，自检完成进入主操作界面。
患者术前告知与准备：告知治疗原理，嘱患者排空膀胱、直肠；摘除全身所有金属物品（手机、首饰、金属内衣扣、心脏起搏器除外植入式器械需提前评估禁忌）。
体位调整：
盆底康复治疗：座椅靠背调至 90° 坐姿，患者臀部完全贴合座椅压力传感区域，双腿自然分开放松。
骶神经 S3 靶向治疗：座椅靠背放平至 180° 俯卧位，线圈中心对准尾骨向上 9cm、中线旁开 2cm 的 S3 神经孔位置。
线圈定位校准：开启实时坐姿监测，调整线圈高度、角度，系统自动识别靶组织位置，完成定位校准。
处方选择：医师主屏根据患者病症选择匹配专家处方，设置刺激强度初始值（从低强度逐步上调至患者耐受舒适范围）。
（二）治疗运行操作
确认患者体位、线圈定位无误，点击主屏 “启动治疗”，设备自动按照预设频率、脉冲、间歇循环输出磁场刺激。
治疗全程实时监测：医师主屏实时显示剩余治疗时长、脉冲计数、输出强度、患者坐姿偏移提示；患者副屏同步显示治疗进度。
强度动态调节：若患者出现酸胀、刺痛不适，医师可实时下调刺激强度；耐受良好可缓慢提升强度，全程以轻微肌肉收缩、无疼痛感为标准。
运动诱发电位检测（可选术前 / 复查）：连接无线 MEP 电极，启动神经检测程序，自动采集运动阈值数据，生成肌力评估报告。
（三）治疗结束收尾
治疗总脉冲完成后，设备自动停止磁场输出，屏幕提示治疗完成。
记录本次治疗参数、患者耐受情况，病例自动存入数据库，可打印本次康复治疗报告。
患者起身离场，使用医用季铵盐消毒剂擦拭座椅、线圈外表面，清除皮肤分泌物、汗液。
短期闲置：关闭主机屏幕，保持设备通电待机；长期闲置（超过 7 天）关闭总电源，线圈归位收纳，整机防尘遮盖。
English
(1) Pre-Treatment Preparation
Power-on self-test of equipment: Connect 220V medical power supply and turn on the main unit power switch. The equipment perｆorms automatic full-unit self-test to confirm no faults in coils, pressure sensors and MEP detection modules, then enters the main operation interface after self-test completion.
Pre-treatment notification and patient preparation: Inｆorm patients of the non-invasive treatment principle, instruct them to empty bladder and rectum; remove all ｍmbedl items from the body (mobile phones, jewelry, ｍmbedl underwear buttons; patients with implantable devices such as pacemakers need taboo evaluation in advance).
Posture adjustment:
Pelvic floor rehabilitation treatment: Adjust seat backrest to 90° sitting posture, patient’s buttocks fully fit the pressure sensing area of the seat, legs naturally separated and relaxed.
S3-targeted sacral nerve treatment: Lay the seat backrest flat to 180° prone position, align the coil center with the S3 foramen position: 9cm upward from coccyx, 2cm lateral to midline.
Coil positioning calibration: Turn on real-time sitting posture monitoring, adjust coil height and angle. The system automatically identifies target tissue position and completes positioning calibration.
Preｓcription selection: On the clinician’s main screen, select the matching expert preｓcription according to the patient’s condition, set the initial stimulation intensity value (gradually increase from low intensity to the patient’s comfortable tolerance range).
(2) Treatment Operation
Confirm correct patient posture and coil positioning, click "Start Treatment" on the main screen. The equipment automatically outputs magnetic stimulation cycles according to preset frequency, pulse duration and interval.
Real-time full-process monitoring: The clinician’s main screen displays remaining treatment duration, pulse count, output intensity and patient posture offset prompts in real time; the patient’s secondary screen synchronously shows treatment progress.
Dynamic intensity adjustment: If the patient feels soreness or stinging discomfort, the clinician can reduce stimulation intensity in real time; intensity can be increased slowly if tolerance is good. The standard throughout treatment is slight muscle contraction without pain.
Motor Evoked Potential Detection (optional for pre-treatment or follow-up): Connect wireless MEP electrodes, start the nerve detection program, automatically collect motor threshold data and generate muscle strength evaluation reports.
(3) Post-Treatment Procedures
After completing the total treatment pulses, the equipment automatically stops magnetic field output and prompts treatment completion on the screen.
Record treatment parameters and patient tolerance status for this session. The case is automatically stored in the database, and the rehabilitation treatment report can be printed.
The patient leaves after treatment. Wipe the outer surfaces of the seat and coil with medical quaternary ammonium salt disinfectant to remove skin secretions and sweat.
Short-term idle: Turn off the main unit screen and keep the equipment powered on standby. Long-term idle (over 7 days): Turn off the main power supply, retract and store the coil, and cover the whole unit with a dust-proof cloth.
六、适应症 Indications
中文
依据注册证适用范围：刺激人体中枢、外周神经，用于神经功能检测、评定、改善；神经电生理检查；神经损伤、腰骶神经功能障碍辅助治疗。 分两大治疗模式临床适应症：
1. 盆底康复模式适应症
产后盆底肌功能康复：顺产 / 剖宫产产后盆底肌力下降、腹直肌分离伴随盆底松弛；产后漏尿、产后盆腔坠胀。
各类尿失禁：压力性尿失禁（咳嗽、大笑、跑跳漏尿）、急迫性尿失禁（突发强烈尿意无法憋尿）、混合型尿失禁。
盆腔器官轻度脱垂：子宫轻度脱垂、阴道壁膨出，改善盆底支撑肌群肌力。
慢性盆腔疼痛、性交疼痛、盆底肌痉挛综合征。
排便功能障碍：盆底肌协同失调、排便费力、排便不尽感。
2. 骶神经调控模式适应症
神经源性膀胱：脊髓损伤、脑卒中、多发性硬化引发的尿频、尿急、尿潴留、残余尿增多。
慢性功能性便秘、术后排便障碍（肛肠手术、妇科术后排便困难）。
骶神经源性慢性盆底、会阴疼痛。
术后尿潴留：妇科、泌尿外科、肛肠术后短期排尿困难，避免留置导尿管。
English
Indications per medical device registration certificate: Stimulate human central and peripheral nerves for detection, evaluation and improvement of nerve function; neuroelectrophysiological examination; adjuvant treatment of nerve injury and lumbosacral nerve dysfunction. Clinical indications divided into two major therapy modes:
1. Pelvic Floor Rehabilitation Mode Indications
Postpartum pelvic floor muscle rehabilitation: Decreased pelvic floor muscle strength after vaginal or cesarean delivery, pelvic floor laxity accompanied by diastasis recti abdominis; postpartum urine leakage and pelvic heaviness.
All types of urinary incontinence: Stress urinary incontinence (urine leakage during coughing, laughing, running or jumping), urge urinary incontinence (sudden strong urge to urinate with inability to hold urine), mixed urinary incontinence.
Mild pelvic organ prolapse: Mild uterine prolapse, vaginal wall bulging, to improve muscle strength of pelvic floor supporting muscles.
Chronic pelvic pain, dyspareunia, pelvic floor spasm syndrome.
Defecation dysfunction: Pelvic floor dyssynergia, straining during defecation, incomplete evacuation sensation.
2. Sacral Neuromodulation Mode Indications
Neurogenic bladder: Frequent micturition, urgent micturition, urinary retention and increased residual urine caused by spinal cord injury, stroke and multiple sclerosis.
Chronic functional constipation, postoperative defecation disorders (difficult defecation after anorectal or gynecological surgery).
Chronic pelvic and perineal pain of sacral neurogenic origin.
Postoperative urinary retention: Short-term dysuria after gynecological, urological and anorectal surgery to avoid indwelling urinary catheters.
七、禁忌症 Contraindications
中文
绝对禁忌症（严禁使用本设备治疗）
体内植入金属、磁性器械：心脏起搏器、植入式心律转复除颤器 ICD、颅内金属支架、骶神经植入刺激器、人工耳蜗、体内金属钢板 / 钢钉。
治疗区域皮肤破损、急性炎症、脓肿、活动性出血、新鲜创面、烧伤、恶性肿瘤病灶（盆腔、骶尾部肿瘤）。
妊娠中晚期（孕 12 周以上）；孕早期需医师充分评估风险后方可谨慎使用。
严重凝血功能障碍、活动性大出血、未控制的血友病。
癫痫、颅内高压、近期颅内出血、重度颅脑损伤未恢复患者。
对交变磁场极度敏感、既往磁刺激出现严重头晕、晕厥、抽搐病史患者。
盆腔、骶尾部急性感染：急性盆腔炎、肛周脓肿、骶尾部蜂窝织炎。
相对禁忌症（医师评估，严密监护下谨慎使用）
严重心功能不全、不稳定心绞痛、近期心梗病史患者。
严重骨质疏松、骶骨、骨盆陈旧性骨折未愈合患者。
精神躁动、无法配合保持治疗体位的患者。
严重感觉减退、肛周 / 会阴完全麻木，无法感知刺激强度的患者。
急性尿路感染、膀胱炎急性期患者，需炎症控制后再开展治疗。
English
Absolute Contraindications (Treatment with this equipment is strictly prohibited)
Implanted ｍmbedl or magnetic devices in the body: Cardiac pacemakers, implantable cardioverter defibrillator (ICD), intracranial ｍmbedl stents, permanently implanted sacral nerve stimulators, cochlear implants, internal ｍmbedl plates or screws.
Broken skin, acute inflammation, abscess, active bleeding, fresh wounds, burns or malignant tumor lesions (pelvic and sacrococcygeal tumors) in the treatment area.
Second and third trimester of pregnancy (over 12 weeks gestation); first trimester use requires full risk assessment by a physician before cautious application.
Severe coagulation disorders, active massive hemorrhage, uncontrolled hemophilia.
Epilepsy, intracranial hypertension, recent intracranial hemorrhage, unrecovered severe craniocerebral injury.
Patients extremely sensitive to alternating magnetic fields with medical history of severe dizziness, syncope or convulsions after previous magnetic stimulation.
Acute pelvic and sacrococcygeal infections: Acute pelvic inflammatory disease, perianal abscess, sacrococcygeal cellulitis.
Relative Contraindications (Comprehensive physician assessment required; use cautiously under close continuous monitoring)
Severe cardiac insufficiency, unstable angina, recent myocardial infarction history.
Severe osteoporosis, unhealed old fractures of sacrum or pelvis.
Agitated psychiatric patients unable to cooperate and maintain treatment posture.
Severe hypoesthesia, complete numbness of perianal and perineal area with inability to perceive stimulation intensity.
Acute urinary tract infection and acute cystitis; treatment shall only be initiated after infection is controlled.
八、注意事项 Precautions
中文
（一）治疗安全操作注意
治疗前必须完整排查患者体内金属植入物，严禁携带金属、磁性物品进入治疗区域，避免磁场干扰植入器械引发危险。
磁场穿透深度可达 4–6cm，严禁将线圈对准头部、心脏、眼球、胎儿区域，仅可作用于盆底、骶尾部靶组织。
治疗强度循序渐进调节，禁止直接设置高强度刺激，防止肌肉剧烈痉挛、头晕恶心。
设备运行中禁止插拔线圈、拆卸传感模块，必须停机断电后再进行配件拆装。
设备出现异响、焦糊气味、屏幕报错、自动频繁停机时，立即切断总电源停止使用，联系厂家售后检修，禁止自行拆机维修。
（二）患者临床监护注意
治疗全程医护人员不得离岗，每 5 分钟询问患者感受，观察有无头晕、心慌、肌肉剧烈抽搐、下腹剧痛等不良反应。
治疗中若患者突发眩晕、恶心、剧烈疼痛，立即点击停机，搀扶患者平躺休息，监测生命体征，必要时对症急救处理。
孕期、高龄、高血压、心脑血管基础病患者，全程低强度刺激，缩短单次治疗时长，密切监测血压、心率。
不可空腹、极度疲劳状态下开展治疗；治疗前嘱患者少量饮水，避免膀胱过度充盈或完全排空引发不适。
（三）院感消毒与耗材维护注意
每位患者治疗完成后，必须使用医用消毒剂擦拭座椅接触面、线圈外壳，待消毒剂自然风干后方可接待下一位患者，防止交叉感染。
设备线圈为精密磁路组件，禁止大力磕碰、摔落、挤压，禁止使用酒精高浓度浸泡擦拭，仅可稀释消毒剂轻柔擦拭表面。
压力传感套件、MEP 电极线缆避免过度弯折拉扯，定期检查线路破损，破损配件及时更换。
整机禁止直接喷淋清水冲洗，清洁仅使用湿润消毒抹布擦拭外壳，防止液体渗入主机电路造成短路烧毁。
（四）存储、环境使用注意
设备放置区域远离高频电刀、射频消融、核磁 MRI 等强电磁设备，强电磁干扰会造成设备参数紊乱、检测数据失真。
治疗诊室保持干燥通风，环境湿度不可过高，避免主机内部电路受潮短路；远离水源、洗手池、消毒喷淋区域。
设备长期闲置时，每周通电空载运行 10 分钟，驱散内部潮气，保护电路与磁线圈精密组件。
运输转运过程做好防震、防潮防护，禁止重物重压主机、线圈，避免剧烈颠簸撞击造成磁路损坏。
English
(1) Safe Operation Precautions for Treatment
Complete screening of implanted ｍmbedl devices in patients before treatment. Carrying ｍmbedl or magnetic items into the treatment area is strictly prohibited to avoid magnetic field interference with implanted devices and potential hazards.
The magnetic field penetration depth reaches 4–6 cm. Never aim the coil at the head, heart, eyeballs or fetal area; it may only act on target tissues of the pelvic floor and sacrococcygeal region.
Adjust treatment intensity gradually; direct setting of high-intensity stimulation is forbidden to prevent severe muscle spasm, dizziness and nausea.
Do not plug/unplug coils or disassemble sensor modules while the equipment is running. Accessories may only be disassembled after shutdown and power cut-off.
If the equipment emits abnormal noise, burnt odor, screen error codes or frequent automatic shutdowns, immediately cut off the main power supply and stop use. Contact manufacturer after-sales service for maintenance; self-disassembly and repair are prohibited.
(2) Clinical Patient Monitoring Precautions
Medical staff shall not leave during the whole treatment process. Ask patients about their comfort every 5 minutes and observe adverse reactions such as dizziness, palpitations, severe muscle convulsions and severe lower abdominal pain.
If the patient suddenly suffers vertigo, nausea or severe pain during treatment, click to stop the machine immediately, assist the patient to lie flat for rest, monitor vital signs and provide symptomatic emergency treatment if necessary.
For pregnant patients, elderly patients and those with hypertension or underlying cardiovascular and cerebrovascular diseases, use low-intensity stimulation throughout treatment, shorten single treatment duration and closely monitor blood pressure and heart rate.
Do not perｆorm treatment on an empty stomach or under extreme fatigue. Instruct patients to drink a small amount of water before treatment to avoid discomfort caused by overfilled or completely empty bladder.
(3) Hospital Infection Disinfection & Equipment Maintenance Precautions
After each patient’s treatment, wipe the contact surface of the seat and coil housing with medical disinfectant. The next patient may only be treated after the disinfectant air-dries naturally to prevent cross-infection.
The equipment coil is a precision magnetic circuit component. Rough impact, dropping and extrusion are prohibited. Do not soak or wipe with high-concentration alcohol; only dilute disinfectant may be used to gently wipe the surface.
Avoid excessive bending and pulling of pressure sensor kits and MEP electrode cables. Inspect cables for damage regularly and replace damaged accessories promptly.
Do not rinse the whole unit with direct water spray. Only use damp disinfection rags to wipe the housing for cleaning, to prevent liquid infiltration into the main unit circuit causing short circuit and burnout.
(4) Storage & Environmental Usage Precautions
Place the equipment far away from strong electromagnetic devices such as high-frequency electrosurgical units, radiofrequency ablation equipment and MRI scanners. Strong electromagnetic interference will disrupt equipment parameters and distort detection data.
Keep the treatment room dry and ventilated with moderate ambient humidity to avoid damp short circuits of internal main unit circuits. Keep separated from water sources, hand washing sinks and disinfection spray zones.
When the equipment is left idle for a long time, power it on and run no-load for 10 minutes every week to dispel internal moisture and protect precision circuit and magnetic coil components.
Implement shock-proof and moisture-proof protection during transportation and transfer. Do not place heavy ｏbjects on the main unit or coils, and avoid severe bumping and impact which may damage the magnetic circuit.
九、存储条件 Storage Conditions
中文
温度条件：长期仓储、闲置存放环境温度 5℃ ~ 40℃；禁止存放于低于 0℃冷冻环境、高于 45℃高温暴晒环境，高温会加速线圈磁芯老化，低温易造成电路元器件失效。
湿度条件：环境相对湿度 10% ~ 80%，存储库房、诊室无凝露、无积水；高湿会造成主机电路板受潮短路、金属配件锈蚀。
光照条件：避光存储，远离阳光直射、紫外线消毒灯长期照射，防止设备外壳塑料老化变脆、显示屏背光衰减。
环境洁净要求：存储区域干燥通风、无尘，远离甲醛、酒精、消毒雾化气体、酸碱腐蚀性化学试剂；腐蚀性气体腐蚀金属线圈支架、电路接口。
堆叠摆放规范：整机主机、配件纸箱水平平放，禁止倒置、侧放、重物堆叠压覆设备；线圈精密组件禁止重压挤压，转运堆叠高度不超过 4 层。
分区隔离存放：磁刺激主机、治疗线圈、传感配件单独分区存放，不可与消杀化学品、强酸强碱试剂、生活垃圾混放。
长期闲置维护存储标准：设备停用超过 7 天，整机覆盖防尘罩；每周通电空载运行 10 分钟驱潮；每月擦拭线圈、座椅表面，避免粉尘长期堆积腐蚀精密部件。
运输临时存储：物流转运全程配备防震泡沫、防潮密封包装；避免雨淋、剧烈撞击、重物挤压；中转临时仓库严格遵循上述温湿度、避光、洁净存储标准。
English
Temperature Requirement: Ambient temperature for long-term storage and idle placement: 5℃ ~ 40℃. Storage in freezing environment below 0℃ or high-temperature sun-exposed environment above 45℃ is prohibited. High temperature accelerates aging of coil magnetic cores, while low temperature easily causes failure of circuit components.
Humidity Requirement: Ambient relative humidity 10% ~ 80%. No condensation or water accumulation in storage warehouses and treatment rooms. High humidity causes damp short circuits of main unit circuit boards and rusting of ｍmbedl accessories.
Light Requirement: Store away from light, keep separated from direct sunlight and long-term UV disinfection lamp irradiation to prevent embrittlement aging of plastic equipment housing and backlight attenuation of display screens.
Environmental Cleanliness Requirement: The storage area shall be dry, ventilated and dust-free, kept separated from ｆormaldehyde, alcohol, disinfection atomizing gas and acid-base corrosive chemical reagents. Corrosive gas corrodes ｍmbedl coil brackets and circuit interfaces.
Stacking Standard: Lay the main unit and accessory cartons horizontally; inversion, lateral placement and heavy ｏbject stacking pressing on equipment are prohibited. Heavy compression of precision coil components is forbidden, and the stacking height during transportation shall not exceed 4 ｌayers.
Zoned Isolation Storage: The magnetic stimulation main unit, therapeutic coils and sensor accessories shall be stored in separate designated zones. Mixing storage with disinfection chemicals, strong acid and alkali reagents and domestic waste is forbidden.
Maintenance Standard for Long-term Idle Storage: Cover the whole unit with a dust-proof cover if the equipment is out of service for more than 7 days. Power on and run no-load for 10 minutes weekly to remove moisture. Wipe coil and seat surfaces monthly to avoid long-term dust accumulation corroding precision components.
Temporary Transit Storage: Equip shock-proof foam and moisture-proof sealed packaging for the whole logistics transportation process. Avoid rain exposure, severe impact and heavy ｏbject extrusion. Temporary transit warehouses shall strictly comply with the above storage standards for temperature, humidity, light avoidance and cleanliness.
十、说明书核心总览 Core Manual Summary
中文
伟思 MagBelle F130 为南京伟思医疗生产的二类医用脉冲磁刺激仪，注册证苏械注准 20222091563，设备由主机、多功能可调治疗座椅、磁刺激线圈、双屏交互系统、压力传感套件、2 通道无线运动诱发电位检测模块组成，采用法拉第电磁感应脉冲磁场技术，磁场可穿透人体 4–6cm 深部组织，无需体内侵入电极，实现盆底肌群、S3 骶神经主被动一体化协同刺激治疗。 设备分为盆底康复、骶神经调控两大标准化治疗模式，内置多套临床专家处方模板，配备实时坐姿压力监测、医患分离双屏操作、全自动循环治疗、神经电生理 MEP 量化检测四大核心功能，用于产后盆底康复、各类尿失禁、盆腔脏器轻度脱垂、慢性盆腔疼痛、便秘、神经源性膀胱、术后排尿排便障碍等腰骶盆底神经功能障碍的辅助治疗与神经功能评估。 绝对禁忌症包含体内磁性金属植入物、妊娠中晚期、治疗区域皮肤肿瘤 / 破损感染、严重凝血障碍、癫痫颅内病变等；孕期、心脑血管基础病、重度骨质疏松等人群为相对禁忌，需医师充分评估并全程严密监护后方可使用。 治疗全程需严格执行无菌消毒、磁场定向安全规范，严禁线圈对准头、心脏、眼球；设备存储需维持 5–40℃、湿度 10%–80% 避光干燥无尘环境，远离强电磁设备与腐蚀性化学品，长期闲置需每周通电驱潮维护。 整机无一次性耗材，线圈、座椅可重复消毒使用，配备过热、过流、短路多重安全保护与故障声光报警，适配医院妇产科、康复科、泌尿外科、肛肠科、产后康复中心，是临床盆底与骶神经康复标准化诊疗设备。
English
Vishee MagBelle F130 is a Class II medical pulsed magnetic stimulator manufactured by Nanjing Vishee Medical Technology Co., Ltd., with medical device registration certificate Su Xie Zhu Zhun 20222091563. The equipment consists of main unit, multi-function adjustable therapeutic seat, magnetic stimulation coil, dual-screen interaction system, pressure sensor kit and 2-channel wireless motor evoked potential detection module. It adopts non-invasive pulsed magnetic field technology based on Faraday’s electromagnetic induction. The magnetic field can penetrate human deep tissues up to 4–6 cm without invasive internal electrodes, realizing integrated active-passive synergistic stimulation therapy for pelvic floor muscle groups and S3 sacral nerves. The equipment has two standardized therapy modes: pelvic floor rehabilitation and sacral neuromodulation, with multiple built-in clinical expert preｓcription templates. It features four core functions: real-time sitting posture pressure monitoring, separated dual-screen operation for doctors and patients, fully automatic cyclic treatment and quantitative neuroelectrophysiological MEP detection. It is applied to adjuvant treatment and neurological function evaluation of lumbosacral and pelvic floor neurological dysfunction, including postpartum pelvic floor rehabilitation, all types of urinary incontinence, mild pelvic organ prolapse, chronic pelvic pain, constipation, neurogenic bladder and postoperative micturition/defecation disorders. Absolute contraindications include implanted magnetic ｍmbedl devices in the body, second/third trimester pregnancy, skin tumors or broken infected skin in treatment area, severe coagulation disorders, epilepsy and intracranial lesions. Groups such as pregnant women, patients with underlying cardiovascular and cerebrovascular diseases and severe osteoporosis are relative contraindications. Full physician assessment and continuous close monitoring are required before use. Strict aseptic disinfection and magnetic field orientation safety specifications shall be implemented throughout treatment. Aiming the coil at the head, heart or eyeballs is strictly prohibited. The equipment shall be stored in a light-proof, dry and dust-free environment with temperature 5–40℃ and relative humidity 10%–80%, kept separated from strong electromagnetic equipment and corrosive chemicals. Weekly power-on moisture removal maintenance is required for long-term idle storage. The whole unit requires no disposable consumables; coils and seats are reusable after disinfection. It is equipped with multi-ｌayer safety protections against overheating, overcurrent and short circuit, as well as audio-visual fault alarms. It is applicable to hospital obstetrics and gynecology, rehabilitation, urology, proctology and postpartum rehabilitation centers, serving as standardized non-invasive clinical diagnosis and rehabilitation equipment for pelvic floor and sacral nerve disorders.
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.
热门标签：厂家供应伟思磁刺激仪MagBelle,F130,伟思磁刺激仪,磁刺激仪F130
