厂商直供英智脑电记录仪Quick-20r
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厂商直供英智脑电记录仪Quick-20r
桂经理19117326863微xin同号
桂经理19117326863微xin同号
产品名称 脑电记录仪
管理类别 第二类
型号规格 Quick-20r
结构及组成/主要组成成分 由放大器、PC端软件、USB接收器、电极和耳夹组成。
适用范围/预期用途 供人体脑电信号动态或静态检测、处理、存储和显示用，不含自动诊断部分。
一、工作原理 Working Principle
中文
人体大脑神经元同步活动会产生微弱生物电信号，透过头皮、颅骨传导至体表；Quick-20r 采用专利主动式干电极直接拾取头皮脑电微弱电位差信号英智科技。
电极采集环节：干电极采用生物兼容导电高分子材料，无需导电凝胶，旋钮调节即可穿透发丝与头皮稳定贴合；电极内置主动屏蔽电路，自动抑制 50/60Hz 工频噪声、运动伪迹，大幅降低接触阻抗与信号噪声英智科技。
信号放大模数转换：头盔内置 24 位高精度低噪声放大器，对微伏级脑电信号无损放大；同步完成模拟 - 数字转换（ADC），实现DC 直流耦合全带宽采集，完整保留慢波、直流电位等全频段脑电原始波形，无硬件滤波修饰原始数据ManualsLib。
实时阻抗监测：每通道搭载独立实时阻抗检测模块，同步采集脑电与电极接触阻抗，机身 LED 灯实时显示接触质量（绿 = 良好 / 黄 = 一般 / 红 = 接触不良），毫秒级超低延迟反馈，保障数据完整性Aerobe。
无线传输与数据处理：低功耗蓝牙模块将数字化脑电信号无线传输至电脑，有效传输距离 10 米；配套 PC 软件接收、存储、可视化展示脑电波形，支持离线数据分析、格式导出；额外 2 路 ExG 拓展通道可同步采集眼电 EOG、肌电 EMG、心电 ECG 等多生理信号同步记录。
10-20 标准定位机制：电极布局严格遵循国际 10-20 脑电定位系统，对应额叶、顶叶、枕叶、颞叶标准脑功能分区，标准化采集点位保障临床、科研数据统一可比。
English
Synchronized electrical activity of human cerebral neurons generates faint bioelectrical signals that conduct through the scalp and skull to the body surface. The Quick-20r adopts patented active dry electrodes to directly capture the tiny potential difference of scalp EEG signals英智科技.
Electrode Acquisition Stage: Dry electrodes are made of biocompatible conductive polymer materials without conductive gel. Knob adjustment enables penetration through hair for stable scalp contact. Each electrode integrates an active shielding circuit to automatically suppress 50/60Hz power frequency noise and motion artifacts, minimizing contact impedance and signal noise英智科技.
Signal Amplification & A/D Conversion: The headset ｅmbeds a 24-bit high-precision low-noise amplifier for lossless amplification of microvolt-level EEG signals. Simultaneous analog-to-digital conversion (ADC) with true DC coupling full-bandwidth acquisition fully retains original waveｆorms including slow waves and DC potentials without hardware filtering modification of raw dataManualsLib.
Real-Time Impedance Monitoring: Each channel is equipped with an independent real-time impedance detection module, synchronously collecting EEG data and electrode contact impedance. On-board LED indicators display contact quality in real time (Green=Good / Yellow=Fair / Red=Poor) with millisecond ultra-low latency feedback to guarantee data integrityAerobe.
Wireless Transmission & Data Processing: A low-power Bluetooth module wirelessly transmits digitized EEG signals to a PC with an effective transmission range of 10 meters. Matching PC software receives, stores and visualizes EEG waveｆorms, supporting offline analysis and ｆormat export. Two additional ExG expansion channels enable synchronous recording of multi-physiological signals including EOG, EMG and ECG.
10-20 Standard Positioning Mechanism: Electrode layout strictly complies with the international 10-20 EEG positioning system, precisely corresponding to standard functional brain regions including frontal, parietal, occipital and temporal lobes. Standardized sampling points ensure consistent and comparable data for clinical and research applications.
二、产品功能 Product Functions
中文
20 通道标准脑电采集：严格 10-20 导联布局，20 导干电极同步采集全脑皮层脑电信号，适配常规脑电图、长时程脑电监测、事件相关电位 ERP 检测英智科技。
双通道 ExG 生理信号拓展：预留 2 路拓展导联，可外接电极同步记录眼电 EOG、肌电 EMG、心电 ECG、皮电 GSR 等外周生理信号，实现脑电 + 多生理同步监测。
全带宽 DC 耦合无损原始数据输出：0~131Hz 完整带宽，直流耦合采集，无硬件滤波裁切波形，输出未修饰原始脑电数据，满足临床判读、科研数据分析需求ManualsLib。
全通道实时阻抗可视化监测：每电极独立阻抗检测，机身彩色 LED 实时直观显示接触状态，软件界面同步展示各通道阻抗数值，快速排查发丝阻隔、贴合不良等问题英智科技。
低功耗蓝牙无线信号传输：内置 BLE 低功耗蓝牙，无线传输距离最远 10 米，被检者可适度自由活动，无线缆拖拽造成的运动伪迹；数据传输延迟＜1ms，同步性。
长时连续数据记录：双 AA 干电池供电，单次满电可连续不间断采集 8 小时，支持门诊短时检查、神经反馈、TMS-EEG 同步监测、心理学实验长时记录场景。
多格式标准化数据导出：采集原始数据支持.EDF/.BDF/.EEG/.CSV 通用格式导出，兼容 BrainVision、EEGLAB、MATLAB、BCI2000、NeuroGuide 等主流脑电分析软件、科研平台ManualsLib。
配套 PC 软件综合管理功能
患者档案管理：录入、存储、检索患者基础信息、历次脑电检查记录；
实时波形可视化：屏幕同步滚动展示 20 导脑电波形、阻抗数值、电池电量；
标记事件触发器：支持手动 / 外接触发器标记刺激事件，用于 ERP 事件相关电位分析；
数据备份导出：一键导出、打印检查报告，支持本地存储、数据备份防丢失。
抗伪迹主动降噪功能：电极级主动屏蔽硬件电路，自动抑制工频干扰、线缆晃动、头部轻微运动产生的伪迹，无需屏蔽室即可采集高质量脑电信号Aerobe。
适配神经调控联合检测：可与英智经颅磁刺激仪 Smart-R10 同步联动，完成 TMS-EEG 同步采集，客观评估磁刺激对大脑皮层神经活动的调控效果英智科技。
English
20-Channel Standard EEG Acquisition: Strict 10-20 montage layout, 20 dry electrodes synchronously collect full cerebral cortex EEG signals, suitable for routine EEG, long-term EEG monitoring and event-related potential (ERP) detection英智科技.
Dual-Channel ExG Physiological Signal Expansion: Two reserved expansion leads support external electrodes for synchronous recording of peripheral physiological signals including EOG, EMG, ECG and GSR, realizing synchronized monitoring of EEG and multi-physiological signals.
Full-Bandwidth DC-Coupled Lossless Raw Data Output: Complete bandwidth from 0 to 131Hz with DC-coupled acquisition. No hardware filtering truncates waveｆorms, outputting unmodified raw EEG data to meet clinical interpretation and scientific research analysis requirementsManualsLib.
Full-Channel Real-Time Visual Impedance Monitoring: Independent impedance detection for each electrode. On-board colored LEDs intuitively display contact status in real time, and the software interface synchronously shows impedance values of all channels for rapid troubleshooting of hair obstruction and poor adhesion英智科技.
Low-Power Bluetooth Wireless Signal Transmission: Built-in BLE low-power Bluetooth with a maximum wireless transmission range of 10 meters. Subjects can move moderately without motion artifacts caused by cable dragging. Data transmission delay is less than 1ms for precise synchronization.
Long-Term Continuous Data Recording: Powered by two AA batteries, fully charged batteries support 8 hours of uninterrupted continuous recording, suitable for short outpatient examinations, neurofeedback, synchronized TMS-EEG monitoring and long-duration psychological experimental recording.
Multi-Format Standardized Data Export: Raw collected data supports export in universal ｆormats including .EDF/.BDF/.EEG/.CSV, compatible with mainstream EEG analysis software and research platｆorms such as BrainVision, EEGLAB, MATLAB, BCI2000 and NeuroGuideManualsLib.
Comprehensive Management Functions of Matching PC Software
Patient File Management: Input, store and retrieve patients’ basic inｆormation and historical EEG examination records;
Real-Time Waveｆorm Visualization: The screen synchronously scrolls to display 20-channel EEG waveｆorms, impedance values and battery power;
Event Trigger Marking: Supports manual/external trigger marking of stimulus events for ERP event-related potential analysis;
Data Backup & Export: One-click export and printing of examination reports, supporting local storage and data backup to prevent data loss.
Active Noise Reduction & Artifact Suppression Function: Electrode-level active shielding hardware circuit automatically suppresses power frequency interference, cable shaking and artifacts generated by slight head movement. High-quality EEG signals can be collected without a shielded roomAerobe.
Compatible with Synchronized Neuroregulation Detection: Can be synchronously linked with Yingchi Smart-R10 TMS device to complete synchronized TMS-EEG acquisition, ｏbjectively evaluating the regulatory effect of magnetic stimulation on cerebral cortical neural activity英智科技.
三、产品特点 Product Features
中文
无凝胶干电极技术，快速穿戴，零耗材：专利生物兼容干电极，无需导电膏、凝胶，避免皮肤刺激、过敏；穿戴调试最快 30 秒完成，无一次性耗材，长期使用成本低，杜绝交叉感染风险。
一体化轻量化头盔设计，佩戴舒适：放大器、采集电路、电极全部集成于柔性复合臂头盔，整机仅 526g；适配 52~62cm 成人、青少年头围，柔性支架贴合头型，单次可舒适佩戴 60 分钟以上，无头部压迫疼痛感ManualsLib。
主动屏蔽硬件降噪，普通诊室即可采集优质信号：每支电极内置独立主动屏蔽电路，从硬件源头抑制工频、运动、线缆伪迹，无需电磁屏蔽室，门诊普通诊疗环境下即可采集媲美湿电极的高质量脑电信号，干 / 湿电极同步采集数据相关性＞0.9英智科技。
毫秒级超低延迟无线传输，同步性：BLE 蓝牙传输延迟＜1ms，脑电波形、阻抗数据实时同步上传电脑；10 米无线活动范围，摆脱有线线缆束缚，适配移动场景、行为心理学实验、VR 脑机接口同步采集。
全通道 LED 实时阻抗可视化，上手门槛低：每个电极点位配备独立彩色 LED 指示灯，绿 = 阻抗合格、黄 = 阻抗偏高、红 = 接触不良，无需紧盯电脑屏幕，技师肉眼快速排查接触问题，新手快速上手操作Aerobe。
DC 直流耦合全带宽原始数据输出，科研级数据质量：24 位高精度 ADC 模数转换，0~131Hz 完整带宽直流耦合采集，不裁切慢波、直流电位，输出无修饰原始脑电波形，满足临床判读、神经科学、脑机接口、ERP 等前沿科研严苛数据要求ManualsLib。
超长续航 8 小时连续采集，适配长时监测：两节 AA 通用干电池供电，满电支持全天门诊不间断检测，适配长时神经反馈、心理实验、TMS 联合监测，无需中途更换电池中断采集流程。
多软件、多格式全兼容，数据互通无障碍：原生兼容 BrainVision 专业脑电平台，数据支持 EDF/BDF 国际通用医疗标准格式，同时适配 EEGLAB、MATLAB、BCI2000、NeuroGuide 等科研软件，临床、科研数据无缝流转分析Aerobe。
拓展多生理信号同步采集，一机多用：标配 2 路 ExG 拓展通道，可同步记录眼电、肌电、心电等外周生理信号，一套设备同时完成脑电 + 多生理同步监测，降低设备采购成本，适配睡眠监测、认知心理学、神经反馈多场景使用。
医用二类合规设备，适配医院全科室：持有 NMPA 二类医疗器械注册证，符合医用电气安全 BF 型应用部分标准，适用于神经内科、精神科、康复科、体检中心、科研实验室，可对接医院 HIS 信息系统，符合医疗机构病案管理规范。
English
Gel-Free Dry Electrode Technology, Fast Wearing & Zero Consumables: Patented biocompatible dry electrodes require no conductive paste or gel, avoiding skin irritation and allergies. Wearing and adjustment can be completed in as fast as 30 seconds. No disposable consumables reduce long-term operating costs and eliminate cross-infection risks.
Integrated Lightweight Headset Design for Comfortable Wearing: Amplifiers, acquisition circuits and electrodes are all integrated into a headset with flexible composite arms. The whole unit weighs only 526g, suitable for adolescent and adult head circumferences from 52 to 62cm. Flexible brackets fit all head shapes, enabling comfortable wearing for over 60 minutes per session without head compression painManualsLib.
Active Shielding Hardware Noise Reduction, High-Quality Signals Collectible in Ordinary Clinics: Each electrode ｅmbeds an independent active shielding circuit to suppress power frequency, motion and cable artifacts at the hardware source. High-quality EEG signals comparable to wet electrodes can be collected in ordinary outpatient treatment rooms without an electromagnetic shielded room. The correlation of simultaneously collected data from dry and wet electrodes exceeds 0.9英智科技.
Millisecond Ultra-Low Latency Wireless Transmission with Excellent Synchronization: BLE Bluetooth transmission delay is less than 1ms, enabling real-time synchronized upload of EEG waveｆorms and impedance data to a PC. The 10-meter wireless movement range breaks the shackles of wired cables, suitable for mobile scenarios, behavioral psychology experiments and synchronized VR BCI acquisition.
Full-Channel LED Real-Time Visual Impedance Monitoring with Low Operation Barrier: Each electrode position is equipped with an independent colored LED indicator (Green=Qualified Impedance / Yellow=High Impedance / Red=Poor Contact). Technicians can quickly troubleshoot contact issues with naked eyes without staring at the computer screen, enabling novice operators to master operation quicklyAerobe.
DC-Coupled Full-Bandwidth Raw Data Output with Research-Grade Data Quality: 24-bit high-precision ADC analog-to-digital conversion, DC-coupled acquisition with complete bandwidth from 0 to 131Hz without truncating slow waves and DC potentials. Unmodified raw EEG waveｆorms are output to meet stringent data requirements for precise clinical interpretation, neuroscience, BCI, ERP and other cutting-edge scientific researchManualsLib.
8-Hour Ultra-Long Battery Life for Continuous Long-Term Monitoring: Powered by two universal AA batteries, fully charged batteries support uninterrupted all-day outpatient examinations, suitable for long-duration neurofeedback, psychological experiments and synchronized TMS monitoring without interrupting data collection for battery replacement mid-session.
Full Compatibility with Multiple Software & Formats for Unobstructed Data Interoperability: Natively compatible with the professional BrainVision EEG platｆorm. Data supports international universal medical standard ｆormats EDF/BDF, and is also compatible with research software including EEGLAB, MATLAB, BCI2000 and NeuroGuide, enabling seamless data transfer and analysis for clinical and research purposesAerobe.
Expandable Synchronized Multi-Physiological Signal Acquisition, Multi-Scenario All-In-One Device: Two standard ExG expansion channels support synchronous recording of peripheral physiological signals such as EOG, EMG and ECG. One device completes synchronized monitoring of EEG and multi-physiological signals simultaneously, reducing equipment procurement costs and applicable to multiple scenarios including sleep monitoring, cognitive psychology and neurofeedback.
Class II Medical Device Compliant for Full Hospital Departments: Holds NMPA Class II medical device registration certificate and complies with medical electrical safety Type BF applied part standards. Suitable for neurology, psychiatry, rehabilitation, physical examination centers and research laboratories. It can connect with hospital HIS inｆormation systems and complies with medical institution medical record management specifications.
四、技术参数 Technical Specifications
中文
产品型号：Quick-20r（V2 升级款）
医疗器械注册证：粤械注准 20222070815
设备整体组成：一体化脑电头盔（20 导干电极 + 集成放大器）、蓝牙 USB 接收器、A1/A2 耳夹参考电极、2 路 ExG 拓展导联、PC 采集分析软件、便携收纳箱
电极导联配置：标准国际 10-20 系统 20 通道脑电电极；2 路可自定义 ExG 拓展通道（EOG/EMG/ECG/GSR）；配套左右耳夹参考电极 A1、A2
电极类型：专利 Drypad 干电极、柔性发丝适配 Flex 电极（可选配件），生物兼容导电高分子材质，单次电极可重复使用 200 次以上
模数转换 A/D 参数：24 位同步采样 ADC，全通道同步采集无通道时序偏差
采样率：500Hz 全通道同步采样
信号带宽：0Hz ~ 131Hz，真实 DC 直流耦合，无高通硬件滤波
噪声水平：1~50Hz 频段噪声＜1.0µV RMS
阻抗检测：全通道独立实时阻抗监测，机身 LED 三色状态指示，阻抗阈值标准 2500kΩ
无线传输参数：低功耗 BLE 蓝牙，有效传输距离 10 米，数据传输延迟＜1ms
电池供电规格：2 节 AA 五号干电池；满电连续采集时长 8 小时
头围适配范围：52cm ~ 62cm（青少年、成人通用）
整机重量：526g（头盔主体，不含电池、导线配件）
安全分类：医用电气设备 I 类 BF 型应用部分，IPX0 防护等级
配套传感器拓展：内置三轴加速度传感器，同步记录头部运动数据，用于运动伪迹校正
数据导出格式：.EDF、.BDF、.EEG、.CSV
适配软件平台：BrainVision Recorder、EEGLAB、MATLAB、BCI2000、NeuroPype、LabStreaming Layer(LSL)、OpenViBE
整机外形尺寸：20cm × 18cm × 19cm
工作环境条件：工作温度 10℃~35℃；环境相对湿度 10%~80%，无凝露、无腐蚀性气体
设计使用年限：5 年
English
Model Number: Quick-20r (V2 upgraded version)
Medical Device Registration Certificate: Yue Xie Zhu Zhun 20222070815
Whole Unit Composition: Integrated EEG headset (20 dry electrodes + integrated amplifier), Bluetooth USB receiver, A1/A2 earclip reference electrodes, 2 ExG expansion leads, PC acquisition & analysis software, portable storage case
Electrode Montage Configuration: 20-channel EEG electrodes following standard international 10-20 system; 2 customizable ExG expansion channels (EOG/EMG/ECG/GSR); matching left and right earclip reference electrodes A1, A2
Electrode Type: Patented Drypad dry electrodes, hair-adaptive flexible Flex electrodes (optional accessories), made of biocompatible conductive polymer material. Each electrode can be reused more than 200 times
A/D Conversion Parameters: 24-bit synchronous sampling ADC, full-channel synchronous acquisition without channel timing deviation
Sampling Rate: 500Hz synchronous sampling for all channels
Signal Bandwidth: 0Hz ~ 131Hz, true DC coupling without high-pass hardware filtering
Noise Level: Noise less than 1.0µV RMS within the 1~50Hz frequency band
Impedance Check: Independent real-time impedance monitoring for all channels, 3-color LED status indicators on headset, standard impedance threshold 2500kΩ
Wireless Transmission Parameters: Low-power BLE Bluetooth, effective transmission range 10 meters, data transmission delay less than 1ms
Battery Power Specification: 2 AA size dry batteries; 8 hours of continuous recording when fully charged
Applicable Head Circumference: 52cm ~ 62cm (universal for adolescents and adults)
Whole Unit Weight: 526g (main headset, excluding batteries and wire accessories)
Safety Classification: Class I medical electrical equipment, Type BF applied part, IPX0 protection grade
Built-In Sensor Expansion: Integrated 3-axis accelerometer to synchronously record head motion data for motion artifact correction
Data Export Formats: .EDF, .BDF, .EEG, .CSV
Compatible Software Platｆorms: BrainVision Recorder, EEGLAB, MATLAB, BCI2000, NeuroPype, LabStreaming Layer (LSL), OpenViBE
Overall External Dimensions: 20cm × 18cm × 19cm
Operating Ambient Conditions: Operating temperature 10℃~35℃; ambient relative humidity 10%~80%, no condensation and no corrosive gas
Designed Service Life: 5 years
五、使用方法 Operation Procedures
中文
（一）检查前设备、患者前期准备
设备通电自检 ① 将 2 节 AA 干电池装入头盔电池仓，扣紧电池盖板；将蓝牙 USB 接收器插入电脑 USB 接口，启动配套采集软件。 ② 打开头盔电源开关，设备自动自检电极通道、蓝牙连接、阻抗检测模块、三轴加速度传感器；软件界面提示 “连接成功”，所有通道 LED 指示灯点亮，无故障弹窗方可使用；若提示通道故障，检查电极是否松动、发丝阻隔。
患者筛查与术前告知 ① 禁忌症筛查：确认患者无头部金属植入物、无严重皮肤破损 / 感染、无严重躁动无法静坐；体内植入心脏起搏器、颅内金属支架等设备禁止使用。 ② 告知检查流程：说明设备为干电极脑电采集，无疼痛、无导电凝胶；检查过程可适度缓慢活动头部，禁止大幅度甩头、起身走动。 ③ 头部预处理：患者摘除眼镜、金属发夹、耳钉、耳机等全部头部金属物品；梳理头发，拨开电极对应点位发丝，保证电极可直接贴合头皮；耳夹夹持耳垂部位，使用医用酒精棉片擦拭耳垂皮肤去除油脂，提升参考电极接触质量。
配件按需装配 ① 需同步采集眼电 / 心电 / 肌电时，将 ExG 拓展导联接入头盔拓展接口，电极贴附于对应眼部、胸部、肌肉部位。 ② 仅常规脑电检查无需拓展导联，收纳存放即可。
（二）头盔佩戴、电极贴合调试（核心步骤）
双手握住头盔两侧把手向外拉开弹性支架，从头顶上方缓慢向下套入患者头部，两侧耳垫贴合患者双耳外围。
调整头盔前后位置：Fp1、Fp2 前额电极位于眉毛上方 1cm 处，Cz 头顶电极垂直贴合颅顶，左右颞叶电极对齐太阳穴区域。
逐通道调节电极旋钮：旋转每个电极尾部调节旋钮，下压电极穿透发丝，直至机身对应通道 LED 灯变为绿色（阻抗合格）；若长期黄色 / 红色，再次拨开点位发丝、微调电极压力，仍不合格更换备用 Flex 柔性电极。
夹持参考电极：A1 耳夹固定于患者左侧耳垂，A2 耳夹可选夹持右侧耳垂，夹紧耳夹保证金属触点贴合耳垂擦拭后的皮肤。
整体复核：轻晃患者头部模拟轻微活动，观察所有电极 LED 保持绿色无变红，确认全部电极接触稳定，无松动、发丝阻隔。
（三）软件参数设置、启动数据采集
软件端录入患者姓名、年龄、检查类型（常规 EEG/ERP/TMS-EEG/ 神经反馈），新建独立患者档案。
设置采集基础参数：采样率固定 500Hz，带宽默认 DC~131Hz；按需开启三轴加速度运动数据同步记录；设置事件触发器（ERP 实验需启用外部刺激标记通道）。
软件界面实时观察 20 导脑电波形、各通道阻抗数值，确认波形平稳无大幅工频、运动伪迹，阻抗全部达标后，点击软件「开始记录」启动脑电采集。
采集过程实时监护：技师全程值守，每 3~5 分钟查看电极 LED 阻抗状态、患者状态；患者出现头部大幅晃动、电极脱落、头晕不适，立即点击「暂停记录」，重新调整头盔电极贴合后再恢复采集；可手动添加事件标记，记录患者眨眼、肢体活动、刺激事件。
（四）采集结束、数据导出、设备清洁收纳
检查完成后，点击软件「停止记录」，系统自动保存本次全部脑电原始数据至患者专属档案；一键导出 EDF/BDF 标准格式文件，用于离线判读、科研分析，按需打印检查波形报告。
拆卸设备流程：先取下耳夹参考电极，松开各电极调节旋钮抬起电极；双手拉开头盔支架，向上取下头盔，取出头盔内干电极备用。
电极、头盔消毒清洁：使用医用稀释季铵盐消毒棉片擦拭干电极金属接触面、头盔塑料支架、耳夹金属触点；擦拭后放置通风处自然风干，禁止使用 75% 高浓度酒精长时间浸泡电极，会腐蚀导电高分子材料降低信号质量。
设备收纳：电池从头盔取出单独存放；干电极、Flex 柔性电极、耳夹、ExG 拓展导联分类收纳于便携收纳箱分隔槽；头盔完整收纳，关闭电源开关，长期闲置断开电池避免亏电损坏设备。
English
(1) Pre-Examination Equipment & Patient Preparation
Equipment Power-On Self-Test ① Install 2 brand-new AA dry batteries into the headset battery compartment and fasten the battery cover. Insert the Bluetooth USB receiver into the computer USB port and launch the matching acquisition software. ② Turn on the headset power switch. The device automatically self-tests electrode channels, Bluetooth connection, impedance detection module and 3-axis accelerometer. The software interface displays "Connection Successful", LED indicators of all channels light up. Operation is allowed only without fault pop-ups. If channel failure is prompted, check for loose electrodes or hair obstruction.
Patient Screening & Pre-Examination Notification ① Contraindication Screening: Confirm the patient has no ｍmbedl head implants, no severe broken/infected skin, and no extreme agitation preventing quiet sitting. Patients with implanted cardiac pacemakers, intracranial ｍmbedl stents and other devices are prohibited from using this device. ② Examination Process Explanation: Inｆorm the patient that the device perｆorms non-invasive dry electrode EEG acquisition without pain or conductive gel. Patients may slowly move their heads moderately during examination; violent head shaking and walking around are forbidden. ③ Head Preprocessing: The patient removes all ｍmbedl head items including glasses, ｍmbedl hair clips, earrings and headsets. Comb hair and brush aside hair at electrode positions to enable direct scalp contact of electrodes. Clip earclips to earlobes and wipe earlobe skin with medical alcohol pads to remove grease and improve reference electrode contact quality.
Accessory Assembly as Required ① For synchronous EOG/ECG/EMG collection, plug ExG expansion leads into the headset expansion port and attach electrodes to corresponding eye, chest and muscle areas. ② Standard routine EEG examination requires no expansion leads; store them separately.
(2) Headset Wearing & Electrode Contact Adjustment (Core Step)
Hold the two side handles of the headset and pull the elastic brackets outward, then slowly lower the headset over the patient’s head from above, with bilateral earpads fitting around the patient’s ears.
Adjust the front-back position of the headset: Forehead electrodes Fp1 and Fp2 are placed 1cm above the eyebrows, the vertex electrode Cz fits vertically on the top of the skull, and bilateral temporal electrodes align with the temple area.
Adjust electrode knobs channel by channel: Rotate the adjustment knob at the tail of each electrode to press the electrode through hair until the corresponding channel LED on the headset turns green (qualified impedance). If the LED remains yellow/red for a long time, re-brush aside hair at the position and fine-tune electrode pressure; replace with spare flexible Flex electrodes if contact still fails.
Attach reference electrodes: Fix earclip A1 to the patient’s left earlobe; earclip A2 is optional for the right earlobe. Fasten the earclip to ensure ｍmbedl contacts fit tightly on alcohol-wiped earlobe skin.
Overall Recheck: Shake the patient’s head slightly to simulate minor movement, observe that all electrode LEDs remain green without turning red, and confirm all electrodes maintain stable contact without loosening or hair obstruction.
(3) Software Parameter Setting & Start Data Acquisition
Input the patient’s name, age and examination type (routine EEG / ERP / TMS-EEG / neurofeedback) in the software and create an independent patient medical record file.
Set basic acquisition parameters: Fixed sampling rate 500Hz, default bandwidth DC~131Hz; enable synchronous recording of 3-axis acceleration motion data as required; set event triggers (enable external stimulus marking channel for ERP experiments).
Observe 20-channel EEG waveｆorms and impedance values of all channels in real time on the software interface. Confirm stable waveｆorms without large power frequency or motion artifacts and all impedance values meet standards, then click "Start Recording" on the software to launch EEG acquisition.
Real-Time Monitoring During Acquisition: Technicians must remain on duty throughout the process, checking electrode LED impedance status and patient condition every 3–5 minutes. If the patient shakes their head violently, electrodes fall off or dizziness occurs, immediately click "Pause Recording", readjust headset electrode contact before resuming acquisition. Manual event markers can be added to record blinks, limb movements and stimulus events.
(4) End of Acquisition, Data Export, Equipment Cleaning & Storage
After examination completion, click "Stop Recording" on the software. The system automatically saves all raw EEG data of this session to the patient’s exclusive file. One-click export of standard EDF/BDF ｆormat files for offline interpretation and scientific research analysis; print waveｆorm examination reports as required.
Equipment Disassembly Process: First remove earclip reference electrodes, loosen all electrode adjustment knobs and lift electrodes. Pull the headset brackets apart with both hands, lift the headset upward, and take out dry electrodes inside the headset for standby use.
Electrode & Headset Disinfection Cleaning: Wipe ｍmbedl contact surfaces of dry electrodes, plastic headset brackets and ｍmbedl earclip contacts with medical diluted quaternary ammonium salt disinfectant pads. Place all accessories in a ventilated area to air-dry naturally after wiping. Long-time soaking of electrodes with high-concentration 75% alcohol is forbidden, as alcohol will corrode conductive polymer materials and degrade signal quality.
Equipment Storage: Remove batteries from the headset and store separately. Classify and store dry electrodes, flexible Flex electrodes, earclips and ExG expansion leads in separate slots of the portable storage case. Fully store the headset and turn off the power switch. Remove batteries for long-term idle storage to prevent battery depletion and equipment damage.
六、适应症 Indications
中文
本设备二类注册预期用途：供人体脑电信号动态或静态检测、处理、存储和显示用，无自动诊断功能，所有判读、评估需执业医师完成。 临床细分适用场景：
神经内科常规脑电图筛查与评估 癫痫发作及癫痫分型辅助鉴别、脑炎、脑膜炎、脑外伤后遗症、脑出血 / 脑梗死脑卒中后遗症、颅内占位病变辅助筛查、阿尔茨海默病、轻度认知障碍、帕金森病脑功能评估、睡眠障碍（失眠、睡眠呼吸暂停、发作性睡病）脑电监测。
精神心理科辅助评估 抑郁症、强迫症、精神分裂症阴性症状、广泛性焦虑、双相情感障碍、创伤后应激障碍 PTSD、儿童注意缺陷多动障碍 ADHD、孤独症谱系障碍、抽动障碍的脑功能客观评估；精神类药物疗效、脑功能变化随访监测。
康复科神经调控配套检测 联合英智经颅磁刺激仪 Smart-R10 完成 TMS-EEG 同步采集，客观评估重复经颅磁刺激对大脑皮层神经兴奋性、脑网络活动的调控效果，预测治疗预后、优化个体化磁刺激治疗方案；脑卒中、脑外伤后认知、运动功能康复疗效监测。
体检中心、健康筛查 中老年人群脑功能常规体检筛查，早期预警认知衰退、脑代谢异常、隐匿性癫痫病灶；亚健康人群失眠、焦虑、记忆力下降的脑电客观评估。
神经科学、心理学科研实验 事件相关电位 ERP 检测、脑机接口 BCI 实验、认知心理学、运动心理学、驾驶行为、VR 交互同步脑电采集；神经反馈训练数据采集与量化评估。
长时程动态脑电监测 门诊短时脑电图、全天 8 小时长程脑电记录，捕捉偶发、隐匿性异常脑电波，提升癫痫、睡眠疾病检出率。
English
Intended use per Class II medical device registration: For dynamic or static detection, processing, storage and display of human EEG signals. It has no automatic diagnostic function; all interpretation and evaluation must be completed by licensed physicians. Subdivided clinical applicable scenarios:
Routine EEG Screening & Evaluation in Neurology Auxiliary differentiation of epileptic seizures and epilepsy classification; EEG monitoring for encephalitis, meningitis, traumatic brain injury sequelae, stroke (cerebral hemorrhage/cerebral infarction) sequelae, auxiliary screening of intracranial space-occupying lesions; cerebral function evaluation for Alzheimer’s disease, mild cognitive impairment and Parkinson’s disease; EEG monitoring for sleep disorders (insomnia, sleep apnea, narcolepsy).
Auxiliary Evaluation in Psychiatry & Psychology Objective cerebral function assessment for depression, obsessive-compulsive disorder, negative symptoms of schizophrenia, generalized anxiety disorder, bipolar disorder, PTSD, pediatric ADHD, autism spectrum disorder and tic disorders; follow-up monitoring of psychiatric drug efficacy and cerebral function changes.
Supporting Detection for Neuroregulation in Rehabilitation Department Synchronized TMS-EEG acquisition linked with Yingchi Smart-R10 TMS device to ｏbjectively evaluate the regulatory effect of repetitive TMS on cerebral cortical neuronal excitability and brain network activity, predict treatment prognosis and optimize individualized TMS therapeutic protocols; rehabilitation efficacy monitoring of cognitive and motor functions after stroke and traumatic brain injury.
Health Screening in Physical Examination Centers Routine cerebral function physical examination screening for middle-aged and elderly populations, early warning of cognitive decline, abnormal brain ｍmbedbolism and occult epileptic foci; ｏbjective EEG evaluation for sub-health populations with insomnia, anxiety and memory loss.
Neuroscience & Psychological Scientific Research Experiments Event-related potential (ERP) detection, BCI brain-computer interface experiments, synchronized EEG acquisition for cognitive psychology, sports psychology, driving behavior and VR interaction; data collection and quantitative evaluation for neurofeedback training.
Long-Term Dynamic EEG Monitoring Short-duration outpatient EEG, 8-hour all-day long-term EEG recording to capture occasional and occult abnormal brain waves, improving the detection rate of epilepsy and sleep disorders.
七、禁忌症 Contraindications
中文
绝对禁忌症（严禁使用本设备采集脑电，存在重大安全风险）
体内植入磁性 / 金属电子医疗器械：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、脑深部电刺激 DBS 装置、颅内动脉瘤金属夹、皮下植入神经刺激器。
头部存在大范围新鲜开放性伤口、深度烧伤、活动性出血、大面积皮肤脓肿、急性化脓性皮炎、头部皮肤恶性肿瘤病灶。
确诊癫痫且近期频繁惊厥发作、未控制癫痫患者；既往脑电检查诱发持续癫痫大发作病史人群。
患者存在严重躁动、重度精神兴奋躁狂发作，无法保持静坐、头部固定，无法配合完成脑电采集。
对导电高分子干电极材料存在严重接触性皮炎、重度过敏，既往佩戴设备后出现头部红肿、水泡、溃烂人群。
危重、生命体征不稳定患者：严重颅内高压、急性脑出血 / 大面积脑梗死急性期、重度感染高热、意识昏迷、休克患者。
相对禁忌症（需执业医师风险获益评估，全程专人监护，仅可短时低强度采集，密切观察患者反应）
头部存在少量浅表擦伤、轻微皮炎、少量陈旧疤痕（避开病灶点位放置电极）。
重度高血压，血压持续≥180/110mmHg 且药物控制不稳定；3 个月内急性心肌梗死、严重心律失常、心功能衰竭患者。
孕期女性：仅在医师评估获益远大于潜在风险时，方可进行头部脑电采集，全程缩短检查时长，避免长时间佩戴头盔。
2 岁以下婴幼儿、75 岁以上高龄老人，神经耐受弱，需大幅缩短单次采集时长，全程监测生命体征。
严重凝血功能障碍、血友病、近期头部 / 颅脑手术未愈合，存在颅内出血风险人群。
青光眼、重度眼底病变、视网膜脱落病史人群，检查过程避免强光刺激屏幕。
English
Absolute Contraindications (Strictly prohibited from using this device for EEG acquisition due to major safety risks)
Implanted magnetic/ｍmbedl electronic medical devices in the body: Cardiac pacemakers, ICD implantable cardioverter defibrillators, intracranial ｍmbedl stents, cochlear implants, intracranial/spinal ｍmbedl plates and screws, DBS deep brain stimulation devices, intracranial aneurysm ｍmbedl clips, subcutaneously implanted nerve stimulators.
Large fresh open wounds, deep burns, active bleeding, extensive skin abscesses, acute suppurative dermatitis and malignant skin tumor lesions on the head.
Patients with confirmed epilepsy and frequent uncontrolled convulsive seizures recently; individuals with a medical history of sustained generalized epileptic seizures induced by previous EEG examinations.
Patients with severe agitation and acute severe manic episodes who cannot remain seated or keep their heads stable to cooperate with EEG acquisition.
Individuals with severe contact dermatitis and severe allergies to conductive polymer dry electrode materials, who developed head swelling, blisters and ulceration after previous headset wearing.
Critically ill patients with unstable vital signs: Severe intracranial hypertension, acute cerebral hemorrhage/acute massive cerebral infarction, severe infection with high fever, coma and shock patients.
Relative Contraindications (Comprehensive risk-benefit assessment by licensed physicians is mandatory; full-time dedicated monitoring throughout examination, only short-duration mild acquisition allowed with close observation of patient reactions)
Minor superficial abrasions, mild dermatitis and small old scars on the head (place electrodes to avoid lesion positions).
Severe hypertension with sustained blood pressure ≥180/110mmHg uncontrolled by medication; patients with acute myocardial infarction within 3 months, severe arrhythmia and cardiac failure.
Pregnant women: Head EEG acquisition is only permitted when physicians evaluate that clinical benefits far outweigh potential risks. Shorten total examination duration and avoid long-time headset wearing throughout the process.
Infants under 2 years old and elderly patients over 75 years old with weak neural tolerance; single acquisition duration must be greatly shortened with continuous vital sign monitoring.
Patients with severe coagulation disorders, hemophilia and unhealed recent cranial/brain surgery with risk of intracranial hemorrhage.
Patients with glaucoma, severe fundus lesions and medical history of retinal detachment; avoid strong light stimulation from the screen during examination.
八、注意事项 Precautions
中文
（一）设备电气、无线安全规范
蓝牙接收器仅可接入合规电脑 USB 2.0/3.0 接口，禁止接入工业大功率设备、高压插座拓展坞，防止电压不稳损坏设备蓝牙模块。
设备采用干电池独立供电，禁止外接直流电源适配器直接给头盔供电，避免电压过载烧毁内置放大器电路。
检查场地远离 MRI 核磁、CT、X 光机、高频电刀、射频消融仪等强电磁设备，最小安全间距≥3 米；强电磁干扰会造成脑电波形伪迹、蓝牙连接断连、阻抗检测数值失真。
设备无线蓝牙信号不得用于涉密医疗数据、患者隐私信息远距离传输，重要脑电原始数据需本地电脑硬盘双重备份存储。
禁止自行拆解头盔放大器、电极内部电路、蓝牙传输模块；设备电路故障仅可联系厂家专业售后工程师检修，私自拆解会破坏设备二类医疗器械合规认证，失去保修服务。
（二）患者临床检查全程监护规范
脑电采集全程必须有持证医师 / 技师在岗监护，不可单独留患者无人看管；每 3~5 分钟观察患者精神状态、电极 LED 阻抗指示灯，及时处理电极脱落、头部不适、头晕恶心等突发情况。
患者佩戴头盔过程中若出现持续头部压迫疼痛、皮肤瘙痒、头晕心慌，立即暂停采集，取下头盔休息 5~10 分钟，评估耐受度后再决定是否继续检查。
癫痫高风险患者（既往惊厥发作、疑似癫痫病灶）检查全程做好应急急救准备，配备吸氧设备、抗惊厥急救药品；一旦患者突发全身抽搐、意识丧失，立刻停机取下头盔，保持呼吸道通畅，启动院内急救流程。
检查前禁止患者空腹、过度疲劳、大量饮酒、服用兴奋性精神类药物；低血糖、醉酒状态会诱发异常脑电波，干扰医师判读结果；检查前 2 小时禁止饮用浓茶、咖啡、能量饮料。
儿童、躁动患者检查前做好情绪安抚，必要时家属陪同；禁止强行按压头部固定头盔，避免擦伤头皮、造成患者心理应激。
（三）电极、头盔消毒与设备维护保养规范
单人单次检查后强制消毒流程：每位患者检查完成后，必须使用医用稀释季铵盐消毒棉片擦拭全部干电极金属接触面、耳夹金属触点、头盔塑料支架、头垫；擦拭后通风静置完全风干，方可接待下一位患者，杜绝皮肤交叉感染风险。
电极材质养护禁令：严禁使用 75% 高浓度酒精、84 消毒液、丙酮、消毒湿巾长时间浸泡、反复擦拭干电极；高腐蚀性液体会腐蚀电极表层导电高分子材料，降低电极导电性能，大幅增加接触阻抗，造成脑电信号噪声变大、波形失真。
线缆、拓展配件防护：ExG 拓展导联、耳夹导线、电极连接线禁止过度弯折、大力拉扯、尖锐物品切割；每周定期检查所有导线外皮是否破损、金属线芯裸露，破损配件立即更换原厂配件，避免漏电、信号断连故障。
电池使用维护：仅使用标准 AA 五号碳性 / 碱性干电池；新旧电池、不同品牌电池禁止混合装入头盔，会造成供电电压不稳，波形出现工频伪迹；设备长期闲置超过 7 天必须取出电池单独存放，防止电池漏液腐蚀头盔内部电路模块，造成损坏。
整机清洁禁止水洗喷淋：头盔、蓝牙接收器、收纳箱整机严禁清水直接冲洗、喷淋；日常清洁仅使用微湿无尘消毒软布轻柔擦拭外壳，严格避免液体渗入头盔电池仓、放大器、电极接口内部，液体渗漏会造成电路短路烧毁精密放大电路，维修成本极高。
（四）存储、转运、环境使用规范
诊室使用环境温湿度管控：检查诊室保持干燥通风，环境相对湿度 10%~80%，无凝露；设备远离洗手池、消毒喷淋、水源潮湿区域摆放，地面保持干燥无积水，防止水汽渗入设备内部腐蚀电路、金属电极。
避光使用与存储：头盔、干电极配件长期存放、诊室摆放需避开阳光直射窗户、紫外线消毒灯；长期强光、紫外线照射会造成头盔塑料支架老化变脆开裂、电极导电高分子材料老化失效，信号质量大幅下降。
转运防护规范：设备跨科室转运、物流运输时，头盔、电极、耳夹、拓展导联全部放入原厂带防震泡沫分隔的便携收纳箱；转运全程避免雨淋浸泡、露天暴晒、剧烈颠簸撞击、重物堆叠挤压收纳箱；剧烈震动会造成头盔内部放大电路、电极触点松动故障，信号采集失真。
长期闲置定期保养：设备停用闲置超过 7 天，头盔完整收纳进防尘收纳箱，取出电池单独存放；每周固定时段取出设备空载开机运行 10 分钟，驱散头盔内部积聚潮气，保护精密放大电路、电极导电层不被潮湿腐蚀老化。
头围适配规范：头盔仅适配 52~62cm 青少年、成人头部；禁止强行拉伸弹性支架适配过小 / 过大头围人群，过度拉伸会造成支架弹性失效，电极无法稳定贴合头皮。
English
(1) Equipment Electrical & Wireless Safety Specifications
Bluetooth receivers can only be connected to compliant computer USB 2.0/3.0 ports. Connection to industrial high-power equipment and high-voltage socket docking stations is forbidden to prevent unstable voltage damage to the device Bluetooth module.
The device is independently powered by dry batteries. Direct power supply to the headset via external DC power adapters is forbidden to avoid voltage overload burning the built-in amplifier circuit.
Examination rooms must be placed far away from strong electromagnetic medical equipment including MRI, CT, X-ray machines, high-frequency electrosurgical units and radiofrequency ablation instruments with a minimum safe distance of ≥3 meters. Severe electromagnetic interference will cause EEG waveｆorm artifacts, Bluetooth disconnection and distorted impedance detection values.
The device Bluetooth wireless signal shall not be used for long-distance transmission of confidential medical data and patient privacy inｆormation. Important raw EEG data must be double-backed up and stored on local computer hard drives.
Disassembly of the headset amplifier, internal electrode circuits and Bluetooth transmission modules by users is strictly forbidden. Circuit faults can only be repaired by professional after-sales engineers from the manufacturer. Unauthorized disassembly will invalidate the Class II medical device compliance certification and void all warranty services.
(2) Full-Process Clinical Patient Monitoring Specifications
Licensed physicians/technicians must remain on duty to monitor patients throughout EEG acquisition; leaving patients unattended alone is prohibited. Observe the patient’s mental status and electrode LED impedance indicators every 3–5 minutes to promptly handle sudden issues including electrode detachment, head discomfort, dizziness and nausea.
If the patient experiences persistent head compression pain, itchy skin, dizziness and palpitations during headset wearing, immediately pause acquisition, remove the headset and let the patient rest for 5–10 minutes. Decide whether to resume examination after evaluating tolerance.
Full emergency first-aid preparations must be ready throughout examination for high epilepsy risk patients (previous convulsive seizures, suspected epileptic foci), equipped with oxygen inhalation equipment and anticonvulsant emergency drugs. In case of sudden generalized convulsions and loss of consciousness, immediately stop the device, remove the headset, keep the airway unobstructed and activate hospital emergency procedures.
Patients are forbidden to undergo examination on an empty stomach, after extreme fatigue, heavy alcohol consumption or taking excitatory psychiatric drugs. Hypoglycemia and drunkenness will induce abnormal brain waves and interfere with physician interpretation results. Consumption of strong tea, coffee and energy drinks is prohibited within 2 hours before examination.
Calm children and agitated patients before examination; accompany by family members when necessary. Forcibly pressing the head to fix the headset is forbidden to avoid scalp abrasion and psychological stress reactions in patients.
(3) Electrode & Headset Disinfection and Equipment Maintenance Specifications
Mandatory disinfection procedure after single patient examination: After each patient completes examination, wipe all ｍmbedl contact surfaces of dry electrodes, ｍmbedl earclip contacts, plastic headset brackets and head pads with medical diluted quaternary ammonium salt disinfectant pads. Ventilate and air-dry completely before receiving the next patient to eliminate cross-infection risks on skin.
Electrode Material Maintenance Prohibition Rules: Long-time soaking and repeated wiping of dry electrodes with high-concentration 75% alcohol, 84 disinfectant, acetone and disinfectant wipes are strictly forbidden. Highly corrosive liquids will erode the conductive polymer ｌayer on electrode surfaces, reduce electrode conductivity, drastically increase contact impedance and cause high noise and distorted EEG waveｆorms.
Cable & Expansion Accessory Protection: ExG expansion leads, earclip wires and electrode connecting wires must not be excessively bent, violently pulled or cut by sharp ｏbjects. Inspect the outer insulation of all wires weekly for breakage and exposed ｍmbedl cores. Replace damaged accessories with brand-new original factory parts immediately to avoid electric leakage and signal disconnection faults.
Battery Usage & Maintenance: Only standard AA carbon/alkaline dry batteries are allowed. Mixing new and old batteries or different brand batteries in the headset is forbidden, which will cause unstable power supply voltage and power frequency artifacts in waveｆorms. Remove all batteries for separate storage if the device is idle for more than 7 days to prevent battery leakage from corroding internal headset circuit modules and causing permanent damage.
Whole Unit Cleaning Prohibition of Water Washing & Spraying: Direct water flushing and spraying of the headset, Bluetooth receiver and storage case are strictly forbidden. Daily cleaning can only be perｆormed by gently wiping the outer shell with slightly damp dust-free disinfection soft cloth. Strictly prevent liquid infiltration into the headset battery compartment, amplifier and electrode interfaces. Liquid leakage will cause short circuits that burn precision amplifier circuits with extremely high maintenance costs.
(4) Storage, Transportation & Ambient Usage Specifications
Examination Room Ambient Temperature & Humidity Control: Keep examination rooms dry and ventilated with ambient relative humidity between 10% and 80% without condensation. Place the device far away from hand washing sinks, disinfection spray areas and humid water source zones; keep floors dry without accumulated water to prevent water vapor infiltration into the device and corrosion of internal circuits and ｍmbedl electrodes.
Light Avoidance for Usage & Storage: Headsets and dry electrode accessories must avoid direct sunlight windows and ultraviolet disinfection lamps during long-term storage and room placement. Long-term exposure to strong light and ultraviolet rays will cause plastic headset brackets to age, become brittle and crack, and degrade electrode conductive polymer materials leading to severe signal quality reduction.
Transportation Protection Specifications: During inter-department transfer and logistics transportation, place the headset, electrodes, earclips and expansion leads entirely into the original factory portable storage case with shock-proof foam dividers. Avoid rain soaking, open-air sunlight exposure, violent bumping impact and heavy goods stacking squeezing the storage case throughout transportation. Severe vibration will loosen internal headset amplifier circuits and electrode contacts leading to faults and distorted signal acquisition.
Regular Maintenance for Long-Term Idle Storage: If the device is idle for more than 7 days, fully store the headset into the dust-proof storage case and remove batteries for separate storage. Take out the device and power on for 10 minutes of no-load operation at fixed times every week to dispel accumulated moisture inside the headset and protect precision amplifier circuits and electrode conductive ｌayers from damp corrosion and aging.
Head Circumference Adaptation Specifications: The headset is only suitable for adolescents and adults with head circumferences from 52cm to 62cm. Forcibly stretching elastic brackets to fit heads that are too small or too large is forbidden; excessive stretching will permanently lose bracket elasticity, making electrodes unable to stably adhere to the scalp.
九、存储条件 Storage Conditions
中文
存储温度标准：整机、电极、配件长期仓储、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℃以上高温阳光暴晒密闭储物间。低温会造成设备内部电路板、电极导电高分子元器件失效损坏；高温加速电池电解液挥发、电极导电层老化脆裂、头盔塑料支架变形老化，缩短整机 5 年设计使用年限。
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头盔内部电路板受潮短路、金属电极、耳夹金属触点锈蚀氧化、散热 / 电路管路内壁滋生霉菌堵塞线路，造成设备开机故障、电极接触阻抗飙升无法采集脑电信号。
避光存储硬性要求：头盔、干电极、柔性电极、耳夹、拓展导联等全套配件整机存储必须避光放置，远离阳光直射窗户、医用紫外线消毒灯长期持续照射储物区域；长期强光、紫外线照射会造成头盔塑料壳体、弹性支架高分子材料老化变脆开裂，电极表层导电高分子材料光降解失效，接触阻抗持续升高，脑电噪声大幅增加，设备信号采集质量性下降。
存储区域洁净度与气体隔离要求：设备存放库房、诊室储物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、84 消毒挥发气体、强酸强碱、挥发性腐蚀性化学试剂存放储物柜；腐蚀性挥发气体持续接触设备金属电极、电路触点、头盔内部放大电路，会造成金属氧化锈蚀、电路触点接触不良、线路腐蚀断路故障，大幅提升设备维修更换配件成本。
堆叠摆放仓储规范：原厂便携防震收纳箱必须水平平放仓储，严格禁止倒置、侧立倾斜摆放、重型重物堆叠重压覆盖收纳箱；头盔内部精密放大电路、电极触点抗压性能极差，重压挤压极易造成电路焊点脱焊、电极导电层碎裂损坏，破坏设备信号采集功能；设备转运仓储堆叠总高度不得超过 4 层，每层收纳箱之间加装防震缓冲隔板分散压力。
分区隔离存放规范：Quick-20r 脑电头盔主机、干电极、Flex 柔性电极、A1/A2 耳夹、ExG 拓展导联、蓝牙 USB 接收器、配套数据线、电池配件必须单独分区隔离存放于收纳箱防震泡沫独立分隔槽内；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放大电路、电极导电层、蓝牙传输模块。
长期闲置设备定期驱潮保养存储标准：设备停用闲置时长超过 7 天，头盔完整收纳进原厂专用防尘防震收纳箱，全部配件分类归置泡沫分隔槽，取出头盔内部两节 AA 干电池单独密封存放；每周固定时段取出整套设备，空载开机运行 10~15 分钟，启动头盔内置电路散热循环，驱散头盔内部、电极缝隙、线路接口积聚潮气，保护精密放大电路、电极导电高分子层不被潮湿腐蚀老化失效；每月使用稀释医用消毒无尘软布轻柔擦拭全部电极、耳夹金属触点、头盔外壳，清除长期堆积粉尘，防止粉尘吸湿附着腐蚀金属触点、堵塞电极接触点位。
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，整套设备完整包裹加厚防震泡沫、密封防潮原厂防护收纳箱；全程防护避免雨水浸泡、露天阳光暴晒、剧烈颠簸撞击、重型货物堆叠挤压收纳箱与内部头盔精密组件；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，若中转存放超过 30 天，需每周取出设备通电空载运行驱潮保养。
English
Storage Temperature Standard: The ambient temperature for long-term warehouse storage and idle room placement of the whole unit, electrodes and accessories shall be stably maintained at 5℃ ~ 40℃. Storage in sub-zero freezing environments and sealed storage rooms exposed to direct sunlight above 45℃ is forbidden. Low temperatures will cause failure and damage to internal circuit boards and electrode conductive polymer components of the device. High temperatures accelerate battery electrolyte volatilization, aging and cracking of electrode conductive ｌayers, and deｆormation and aging of plastic headset brackets, shortening the 5-year designed service life of the whole unit.
Storage Humidity Standard: The relative humidity of storage warehouses and examination rooms is strictly controlled at 10% ~ 80%, with no condensation, accumulated water or water seepage in the storage area at all times. Excessively high ambient humidity will cause damp short circuits of internal headset circuit boards, rust and oxidation of ｍmbedl electrodes and ｍmbedl earclip contacts, and mold growth inside circuit pipelines blocking wiring, resulting in power-on faults of the device and sharply elevated electrode contact impedance that prevents EEG signal acquisition.
Mandatory Light-Avoidance Storage Requirement: The whole set of accessories including headset, dry electrodes, flexible Flex electrodes, earclips and expansion leads must be stored away from light, far from storage areas exposed to long-term continuous irradiation of direct sunlight windows and medical ultraviolet disinfection lamps. Long-term exposure to strong light and ultraviolet rays will cause aging, brittleness and cracking of plastic headset shells and elastic bracket polymer materials, photodegradation failure of conductive polymer ｌayers on electrode surfaces, continuously rising contact impedance, drastically increased EEG noise and permanent degradation of the device’s signal acquisition quality.
Storage Area Cleanliness & Gas Isolation Requirements: Storage warehouses and examination room storage zones for the device must be kept dry, ventilated and dust-free. Store far away from lockers containing ｆormaldehyde, atomized high-concentration alcohol disinfection gas, 84 disinfectant volatile gas, strong acids, strong alkalis and volatile corrosive chemical reagents. Continuous contact of corrosive volatile gas with device ｍmbedl electrodes, circuit contacts and internal headset amplifier circuits will cause ｍmbedl oxidation and rust, poor contact of circuit contacts and circuit corrosion open-circuit faults, drastically increasing equipment maintenance and accessory replacement costs.
Stacking Warehouse Storage Specifications: The original factory portable shock-proof storage case must be stored horizontally flat. Inverted placement, inclined side placement and stacking heavy weights to press down the storage case are strictly forbidden. The precision amplifier circuits and electrode contacts inside the headset have extremely poor compression resistance. Heavy extrusion easily causes circuit solder joint detachment and fragmentation damage of electrode conductive ｌayers, permanently destroying the device’s signal acquisition function. The total stacking height of storage cases during transportation and warehousing shall not exceed 4 ｌayers, and shock-proof buffer partitions shall be installed between each ｌayer of storage cases to disperse pressure.
Partitioned Isolated Storage Specifications: The Quick-20r EEG headset main unit, dry electrodes, flexible Flex electrodes, A1/A2 earclips, ExG expansion leads, Bluetooth USB receivers, matching data cables and battery accessories must be stored separately in independent shock-proof foam partition slots of the storage case. Mixing storage with disinfection chemicals, strong acid/alkali chemical reagents, domestic garbage and damp water-containing sundries is forbidden to avoid chemical corrosion and water seepage dampness damaging the device’s precision amplifier circuits, electrode conductive ｌayers and Bluetooth transmission modules.
Regular Moisture Removal Maintenance Storage Standard for Long-Term Idle Equipment: If the device is idle for more than 7 days, fully store the headset into the original factory dedicated dust-proof and shock-proof storage case, classify all accessories into foam partition slots, take out the two AA dry batteries inside the headset and store them separately in sealed packaging. Take out the whole set of equipment at fixed times every week, power on for 10~15 minutes of no-load operation, activate the internal headset circuit heat dissipation cycle to dispel accumulated moisture inside the headset, electrode gaps and line interfaces, protecting precision amplifier circuits and electrode conductive polymer ｌayers from damp corrosion and aging failure. Wipe all electrodes, ｍmbedl earclip contacts and headset shell gently with diluted medical disinfection dust-free soft cloth every month to remove long-term accumulated dust, preventing dust moisture absorption adhesion that corrodes ｍmbedl contacts and blocks electrode contact positions.
Temporary Warehouse Storage Standard for Logistics Transportation: During long-distance logistics transportation and transit temporary warehousing, fully wrap the whole set of equipment with thick shock-proof foam and seal it in the original factory moisture-proof protective storage case. Protect throughout transportation to avoid rain soaking, open-air sunlight exposure, severe bumping impact and stacking heavy goods squeezing the storage case and internal precision headset components. Transit temporary warehouses must strictly implement all the above temperature, humidity, light avoidance and clean partition storage standards. Transit storage duration shall not exceed 30 days. If stored for more than 30 days, the equipment must be taken out weekly for power-on no-load operation for moisture removal maintenance.
十、说明书核心信息 Summary of Core Manual Inｆormation
中文
产品基础资质 产品名称：脑电记录仪；型号：Quick-20r（V2 升级款）；二类医疗器械注册证：粤械注准 20222070815；生产企业：深圳英智科技有限公司；设备类型：无线干电极 20 通道医用脑电图采集设备；应用部分安全等级：I 类 BF 型；设计使用年限：5 年。
核心核心技术核心优势 无需导电凝胶专利干电极、一体化轻量化头盔、全通道 LED 实时阻抗可视化、DC 直流耦合全带宽原始数据输出、低延迟 10 米蓝牙无线传输、8 小时长续航、2 路 ExG 多生理信号拓展、主动屏蔽硬件抗干扰，普通诊室无需屏蔽室采集科研级脑电原始数据。
设备标准配套清单 20 导干电极一体化头盔（内置放大器）、蓝牙 USB 无线接收器、A1/A2 双耳夹参考电极、2 路 ExG 拓展导联、原厂便携防震防尘收纳箱、AA 五号干电池、配套 PC 采集分析软件安装包、产品说明书、医用消毒擦拭棉片、备用 Flex 柔性发丝适配电极配件。
设备核心使用限制 仅适配 52~62cm 成人、青少年头围；不可用于体内植入磁性金属医疗器械患者；不可用于头部大面积破损感染皮肤人群；检查全程必须持证专业医护人员监护；无自动诊断功能，所有脑电波形判读、临床评估必须由具备资质执业医师完成；设备仅用于脑电及配套生理信号采集记录，不可作为治疗设备使用。
设备安全与维护核心要求 独立干电池供电，禁止外接电源直连头盔；远离 MRI、CT 等强电磁设备，安全间距≥3 米；单人单次检查后必须完整消毒电极、头盔接触面；长期闲置需取出电池，每周通电驱潮保养；禁止酒精长时间浸泡电极，避免腐蚀导电材料；整机不可水洗喷淋，仅可微湿布擦拭外壳；转运必须使用原厂防震收纳箱，避免剧烈震动损坏内部精密电路。
数据与软件核心规范 采集原始数据无硬件滤波修饰，支持 EDF/BDF 国际医疗标准格式导出；兼容 BrainVision、EEGLAB、MATLAB 等主流科研、临床脑电分析软件；配套 PC 软件具备患者档案管理、实时波形可视化、阻抗数值监控、事件标记、数据备份导出、标准化报告打印全套功能；脑电原始数据需本地电脑双重备份，涉密、隐私数据禁止无线远距离传输。
存储、转运、环境核心标准 存储温湿度 5~40℃、相对湿度 10%~80%，避光无尘、无腐蚀性气体；水平平放收纳箱，禁止重压堆叠；长期闲置每周通电驱潮；诊室使用环境干燥通风，远离水源、消毒喷淋、强电磁设备；物流转运全套防震防潮包装，中转仓储不超过 30 天，超时每周保养。
故障应急与售后核心说明 设备出现通道故障、蓝牙断连、电极阻抗持续偏高、设备异响异味，立即停机切断电源，取出电池，禁止自行拆解维修，时间联系厂家官方售后工程师上门检修；整机原厂标准保修 2 年，电极、耳夹、导线等耗材配件损耗不在整机保修范围内，可单独采购原厂替换配件；日常仅允许使用配套医用季铵盐消毒用品清洁设备，其他腐蚀性消毒产品禁止使用。
English
Basic Product Qualifications Product Name: EEG Recorder; Model: Quick-20r (V2 upgraded version); Class II Medical Device Registration Certificate: Yue Xie Zhu Zhun 20222070815; Manufacturer: Shenzhen Yingchi Technology Co., Ltd.; Equipment Type: Wireless dry-electrode 20-channel medical EEG acquisition device; Applied Part Safety Class: Class I Type BF; Designed Service Life: 5 years.
Core Technology & Key Advantages Patented gel-free dry electrodes, integrated lightweight headset, full-channel LED real-time visual impedance monitoring, DC-coupled full-bandwidth raw data output, low-latency 10-meter Bluetooth wireless transmission, 8-hour long battery life, 2 ExG multi-physiological signal expansion channels, active shielding hardware anti-interference technology.
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：厂商直供英智脑电记录仪Quick-20r,脑电记录仪Quick-20r,英智脑电记录仪
