厂家直供诺诚表面肌电图仪MyoMove-EOW
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厂家直供诺诚表面肌电图仪MyoMove-EOW
桂经理19117326863微xin同号
桂经理19117326863微xin同号
管理类别
第二类
型号规格
MyoMove-COW、MyoMove-DOW、MyoMove-EOW
结构及组成/主要组成成分
产品由表面肌电图仪主机、表面肌电图仪一体化电极线、工作站、软件（表面肌电图仪、版本号V2）、理疗电极片、摄像头（选配）组成。
适用范围/预期用途
用于记录肌肉静止或收缩时的电活动。
1 工作原理 Working Principle
中文：MyoMove‑EOW 为表面肌电（sEMG）设备，通过放置于人体皮肤表面的非侵入式电极，采集肌肉收缩 / 静息状态下运动单元产生的微弱肌电生物电信号；经放大器放大、滤波、模数转换后，由工作站软件完成信号解析、运算，输出肌电波形、量化指标，实现肌肉功能评估与肌电生物反馈训练。English：MyoMove‑EOW is a surface electromyography (sEMG) device. Non‑invasive surface electrodes placed on skin capture faint bio‑electrical signals generated by motor units during muscle contraction and relaxation. Signals are amplified, filtered and A/D‑converted. Workstation software processes and computes data to output sEMG waveｆorms and quantitative metrics for muscle function assessment and sEMG biofeedback training。
2 产品功能 Product Functions
中文
16 通道同步表面肌电信号采集，实时波形监测；
肌电量化分析：疲劳度、频率谱、RMS、均值、功率谱、肌肉对称度、协调性分析；
专项临床评估方案：肌力肌张力评估、斜颈评估、脑瘫少儿下肢评估、面瘫评估、吞咽障碍评估，支持自定义评估模板；
多媒体游戏式生物反馈训练：肌肉放松训练、肌力强化训练、协调性训练、准确度训练、抗疲劳训练；
病例管理、数据回放、报告预览、打印输出；
WIFI 无线数据传输，支持离线数据存储nation.361...。
English
16‑channel synchronous sEMG acquisition with real‑time waveｆorm monitoring;
Quantitative sEMG analysis: fatigue index, frequency spectrum, RMS, mean value, power spectrum, muscle symmetry and coordination analysis;
Specialized clinical assessment protocols: muscle strength‑tone evaluation, torticollis assessment, pediatric CP lower‑limb assessment, facial palsy assessment, dysphagia assessment, user‑customizable templates supported;
Multimedia game‑based biofeedback training: muscle relaxation, muscle strengthening, coordination, accuracy and anti‑fatigue training;
Patient case management, data playback, report preview and printout;
WIFI wireless data transmission and offline data storage。
3 产品特点 Product Features
中文
16 通道同步采集，可同时监测多组肌肉；
高抗干扰放大模块，共模抑制比高，适配复杂临床环境；
表面电极检测，伤，可重复多次检测；
一体化软硬件工作站，内置多套成熟临床评估范式；
无线 WIFI 传输，摆脱线缆束缚，适用于步态、动态运动场景；
可视化多媒体反馈训练，提升患者康复参与度；
完整病例数据库，便于随访对比、康复效果追踪；
便携式主机，可搭配移动台车，病房、康复室均可部署。
English
16‑channel simultaneous acquisition for multi‑muscle monitoring;
High‑CMRR anti‑interference amplifier, suitable for complex clinical environment;
Non‑invasive surface electrode measurement, repeatable examinations;
Integrated hardware‑software workstation with built‑in mature clinical assessment paradigms;
WIFI wireless transmission, cable‑free for gait and dynamic motion tests;
Visual multimedia biofeedback to improve patient rehabilitation compliance;
Complete patient database for follow‑up comparison and rehabilitation outcome tracking;
Portable main unit compatible with mobile cart, deployable in ward and rehabilitation roomnation.361...。
4 主要技术参数 Main Technical Specifications
表格
| 中文 | English |
|---|---|
| 通道数：16 通道 | Number of channels: 16 channels |
| 显示灵敏度：0.05 µV/div‑20000 µV/div；误差≤±10%（50 µV/div 以下不作精度要求） | Display sensitivity: 0.05 µV/div‑20000 µV/div; error ≤±10% (accuracy not specified below 50 µV/div) |
| 幅频特性：0.2 Hz‑10 kHz | Amplitude‑frequency characteristic: 0.2 Hz‑10 kHz |
| 扫描速度：1 ms/div‑5000 ms/div，误差≤±10% | Sweep speed:1 ms/div‑5000 ms/div; error ≤±10% |
| 高通滤波（低切）：0.1 Hz‑5000 Hz | High‑pass filter(low cut):0.1 Hz‑5000 Hz |
| 低通滤波（高切）：10 Hz‑20000 Hz | Low‑pass filter(high cut):10 Hz‑20000 Hz |
| 共模抑制比：≥110 dB | CMRR (Common‑Mode Rejection Ratio): ≥110 dB |
| 输入阻抗：≥1000 MΩ | Input impedance: ≥1000 MΩ |
| 输入噪声电压：≤0.4 µV (rms) | Input noise voltage: ≤0.4 µV(rms) |
| 耐极化电压：±300 mV 直流极化，信号偏差≤±5% | Polarization tolerance: ±300 mV DC polarization, signal deviation ≤±5% |
| 通讯方式：WIFI 无线 + 有线 | Communication: WIFI wireless & wired |
| 软件版本：V2.0 | Software version: V2.0 |
| 设备组成：主机、放大器、电极线缆、电极片配件、计算机工作站、台车（选配）、摄像头（选配） | System components: main unit, amplifier, electrode cables, electrode accessories, PC workstation, cart(optional), camera(optional) |
参数来源医疗器械注册产品技术要求。
5 使用方法 Operating Method
中文
设备安装：连接主机、放大器、工作站，接通隔离电源，启动系统软件；
皮肤预处理：被测部位皮肤清洁、去角质、脱脂，保证电极‑皮肤接触阻抗达标；
电极贴放：按解剖定位粘贴表面电极与参考电极，确认电极线缆连接牢固；
通道配置：软件新建患者病例，设置采集通道、滤波参数、采样方案，选择评估 / 训练模式；
信号校准：执行系统定标，检查基线噪声，排除接触不良与干扰；
检测 / 训练：执行表面肌电采集评估，或启动多媒体生物反馈训练，记录测试全程数据；
结束操作：停止采集，保存病例数据，可回放、分析、生成打印报告；
收尾：关闭软件与设备电源，拆卸电极，清洁电极线缆，整理配件。
English
System setup: Connect main unit, amplifier and workstation; power on with isolated power supply and launch software.
Skin preparation: Clean, abrade and degrease target skin area to achieve acceptable electrode‑skin impedance.
Electrode placement: Attach surface electrodes and reference electrode according to anatomical landmarks; secure electrode cables.
Channel configuration: Create new patient record in software; set channels, filter parameters and sampling scheme; select assessment or training mode.
Signal calibration: Run system calibration; inspect baseline noise; eliminate poor contact and interference sources.
Examination / training: Start sEMG acquisition‑assessment or multimedia biofeedback training; record full‑session data.
Post‑acquisition: Stop acquisition and save patient data. Perｆorm data playback, analysis, report generation and printing.
Shut‑down: Exit software and power off equipment; remove electrodes; clean cables and organize accessories。
6 适应症 / 预期用途 Indications / Intended Use
中文：用于医疗机构开展常规表面肌电图实时监测；适用于康复科、神经内科、儿科等科室，对肌肉活动状态做评估；用于肌力、肌张力、肌肉疲劳、运动协调性评估；开展肌电生物反馈康复训练，辅助斜颈、脑瘫后遗症、面瘫、吞咽障碍等肌肉运动功能障碍的康复评价与训练。本设备仅作评估与康复训练，不用于侵入式针极肌电图检测，不作独立确诊依据。
English：Intended for real‑time monitoring of routine surface electromyography in medical institutions. Applied in rehabilitation, neurology, pediatrics for non‑invasive evaluation of muscular activity. Used to assess muscle strength, muscle tone, muscle fatigue and motor coordination; perｆorm sEMG biofeedback rehabilitation training to assist evaluation and training for motor dysfunctions such as torticollis, sequelae of cerebral palsy, facial palsy and dysphagia. This device is for assessment and rehabilitation training only. Not for invasive needle EMG; cannot be used as sole diagnostic basis。
7 禁忌症 Contraindications
中文
体内植入心脏起搏器、植入式除颤器等有源植入器械患者禁止使用本设备生物反馈输出功能；可仅做采集评估，必须经临床医师风险评估；
检测部位皮肤破损、感染、皮炎、烧烫伤，禁止在患处贴放电极；
癫痫发作未得到控制的患者慎用多媒体反馈训练模式；
危重、生命体征不稳定患者不适用；
禁止用于颅内、心脏等体内侵入式检测。
English
Biofeedback output function is contraindicated for patients with active implanted devices such as cardiac pacemaker or implantable cardioverter‑defibrillator. Acquisition‑only mode may be allowed upon clinician risk assessment.
Do not place electrodes over skin lesions, infection, dermatitis or burn wounds.
Multimedia feedback training shall be used with caution in patients with uncontrolled epilepsy.
Not suitable for critically‑ill patients with unstable vital signs.
Forbid invasive intracardiac or intracranial measurement.
8 注意事项 Precautions
中文
医疗机构由经培训的医护 / 康复技术人员操作使用；
使用隔离变压器供电，设备须可靠接地，避免漏电风险；
电极‑皮肤阻抗过高会造成信号失真，测试前必须做好皮肤准备；
远离高频电刀、理疗仪等强电磁干扰设备，避免信号漂移；
一次性电极不可重复使用；复用电极每次使用后清洁消毒；
设备输出为生物反馈信号，非治疗电刺激输出；
设备评估结果仅供临床参考，不能单独作为疾病确诊依据；
出现皮肤过敏、瘙痒应当立即停止测试，移除电极；
设备软件不得随意修改参数，不得外接非原厂配件；
定期做设备性能校验，维护放大器与线缆完好；
儿童受试者全程需要监护人员陪同。
English
Operated only by trained medical / rehabilitation personnel within medical institutions.
Power supply via isolation transｆormer with reliable protective earthing against electric leakage hazard.
Excessively high electrode‑skin impedance causes signal distortion; adequate skin preparation is mandatory before testing.
Keep away from high‑frequency electrosurgical units and physiotherapy equipment to avoid electromagnetic interference and signal drift.
Disposable electrodes shall not be reused; reusable electrodes shall be cleaned and disinfected after each use.
Device delivers biofeedback signal only, NOT therapeutic electrical stimulation output.
Assessment results are for clinical reference only and shall not serve as sole diagnostic evidence.
Terminate examination and remove electrodes immediately in case of skin allergy or pruritus.
Do not arbitrarily modify software parameters or connect non‑original accessories.
Periodically perｆorm perｆormance verification; maintain amplifier and cable integrity.
Pediatric subjects require continuous attendant supervision.
9 存储条件 Storage Conditions
中文
环境温度：‑10 ℃ ~ +40 ℃
相对湿度：10%‑80%，无凝露
大气压力：70 kPa‑106 kPa
存放环境：干燥、通风、无尘；避免阳光直射、雨水淋溅；远离腐蚀性气体；长期不用应断电收纳，电极配件按耗材说明书单独保存。
English
Ambient temperature:‑10 ℃ ~ +40 ℃
Relative humidity:10%‑80%, non‑condensing
Atmospheric pressure:70 kPa‑106 kPa
Storage environment: dry, ventilated and dust‑free; avoid direct sunlight, water splash and corrosive gas. Power off for long‑term storage. Store electrode accessories separately per consumable IFU.
10 产品基本信息 Basic Product Inｆormation
中文产品名称：表面肌电图仪 型号：MyoMove‑EOW 注册人：上海诺诚电气股份有限公司 管理类别：第二类医疗器械
EnglishProduct Name: Surface Electromyograph Model: MyoMove‑EOW Registrant: Shanghai NCC Electric Co., Ltd. Device Class: Class Ⅱ Medical Device
免责声明：以上产品详情仅供参考，临床操作请以原厂纸质说明书为准。上海康世达医疗器械有限公司不生产医疗产品，所有产品均来自产品的生产厂家，代理商，经销商，如有侵权请联系我们，会尽快处理！The above product details are for reference only. All clinical operations shall be carried out in strict accordance with the original paper instructions for use issued by the manufacturer.
Shanghai Kangshida Medical Devices Co., Ltd. does not manufacture medical devices. All products are sourced from respective manufacturers, authorized agents and distributors.
Please contact us promptly in case of any infringement, and we will resolve the matter as soon as possible.
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