厂家供应博睿康数字脑电图机NSE1,NSE2,NSE3
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品牌名称：$brandModel.Title型号： 原产地：中国大陆 医疗器械注册号(批文)：苏械注准20242071633更新时间：2026/10/16 11:04:35
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厂家供应博睿康数字脑电图机NSE1,NSE2,NSE3
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
NSE1、NSE2、NSE3
结构及组成/主要组成成分
数字脑电图机由脑电信号采集部分、闪光刺激器部分和数字脑电采集记录系统软件三部分组成。其中脑
电信号采集部分由主机、头盒、头盒连接电缆、医用电源适配器、电源线、事件按键、网线组成；闪光
刺激器部分为选配件，由闪光刺激器主机、USB数据线、Trigger IN线缆、灯头、灯头连接电缆组成；
数字脑电采集记录系统软件发布版本号为1。
适用范围/预期用途
适用于临床脑电信号的采集和监测。
1. 工作原理 Working Principle
中文设备通过粘贴于头皮的电极采集大脑神经元活动产生的微弱脑生物电信号；信号传输至头盒放大器完成阻抗转换、放大、滤波，经 A/D 模数转换将模拟脑电信号转为数字信号；主机传输至配套软件完成实时波形显示、存储、处理与分析，实现临床脑电采集、记录与监护；选配闪光刺激器可输出光刺激，用于诱发脑电响应，辅助诱发试验。
EnglishThe device acquires weak bio‑electrical signals generated by cerebral neuron activities via scalp electrodes. Signals are sent to the head‑box amplifier for impedance conversion, amplification and filtering. Analog EEG signals are converted into digital signals by A/D conversion. Digital data are transmitted to host computer and software for real‑time waveｆorm display, storage, processing and analysis to realize clinical EEG acquisition, recording and monitoring. Optional photic stimulator delivers light stimuli to evoke EEG responses for provocation tests.
2. 产品功能 Functions
中文
多通道脑电信号同步采集、实时波形显示；
实时电极阻抗检测，评估电极接触质量；
脑电数据本地存储、回放、检索；
滤波、灵敏度、走纸速度参数可调；
事件标记、手动事件按键标记；
振幅整合脑电图 aEEG、脑功能趋势、时频分析、频段功率分析；
选配：闪光刺激诱发试验、视频同步记录脑电‑画面同步；
报告预览、导出打印。
English
Multi‑channel synchronous EEG acquisition and real‑time waveｆorm display.
Real‑time electrode impedance monitoring for electrode‑skin contact quality evaluation.
Local EEG data storage, playback and retrieval.
Adjustable filter, sensitivity and paper‑speed parameters.
Event annotation and manual event‑key marking.
aEEG (amplitude‑integrated EEG), cerebral function trending, time‑frequency analysis, frequency‑band power analysis.
Optional: photic stimulation provocation test, synchronized video‑EEG recording.
Report preview, export and printout.
3. 产品特点 Product Features
中文
24 位高精度 ADC，微伏级微弱脑电信号还原；
高共模抑制比，病房、ICU、手术室复杂电磁环境抗干扰；
支持国际 10‑20 电极标准导联体系；
实时阻抗检测，快速排查电极接触异常；
兼顾常规脑电图长时程连续脑功能监护；
模块化配置，闪光刺激器、视频模块可选配；
医用隔离电源，满足医用电气安全标准 GB9706.1‑2020；
软件集成监护 + 诊断分析功能，适配神经内科、ICU、儿科、睡眠中心多科室场景。
English
24‑bit high‑precision ADC for restoration of micro‑volt level weak EEG signals.
High CMRR (Common‑Mode Rejection Ratio), strong anti‑interference perｆormance for wards, ICU and operating rooms with complex electromagnetic environment.
Compliant with international 10‑20 electrode placement standard.
Real‑time impedance check for fast troubleshooting of poor electrode contact.
Support both routine EEG and long‑term continuous cerebral function monitoring.
Modular configuration; photic stimulator and video module are optional accessories.
Medical isolated power supply, complying with GB9706.1‑2020 medical electrical safety standard.
Software integrates monitoring and diagnostic analysis, applicable for neurology, ICU, pediatrics and sleep centers.
4. 技术参数 Technical Specifications
表格
| 中文 | English |
|---|---|
| 型号：NSE1 / NSE2 / NSE3 | Models: NSE1 / NSE2 / NSE3 |
| 采集通道：32 通道 | Acquisition Channels: 32 channels |
| A/D 分辨率：24 bit | A‑D Resolution: 24 bit |
| 采样率：最高 2048Hz 可调 | Sampling Rate: up to 2048 Hz adjustable |
| 输入阻抗：≥100 MΩ | Input Impedance: ≥100 MΩ |
| 共模抑制比 CMRR：≥110 dB | CMRR: ≥110 dB |
| 系统噪声：≤1 µV (峰峰值) | System Noise: ≤1 µV (peak‑to‑peak) |
| 通讯接口：网线 / USB | Communication Interface: Ethernet / USB |
| 软件版本：V1 | Software Version: V1 |
| 工作环境温度：10 ℃～40 ℃ | Operating Temperature: 10 ℃～40 ℃ |
| 工作相对湿度：30%～75% RH | Operating Humidity: 30%‑75% RH |
| 电源：医用隔离适配器 | Power Supply: Medical isolated adapter |
5. 使用方法 Operating Method
中文
设备安装：连接主机、头盒、电源适配器、通讯线缆；启动采集软件；
按照国际 10‑20 系统摆放头皮电极，涂抹导电膏，固定电极；
执行阻抗检测，调整电极至阻抗达到合格范围；
设置采集参数（采样率、滤波、灵敏度等），开始脑电记录；
需要时使用事件按键标记临床事件；选配闪光刺激器执行诱发试验；
记录完成，停止采集，保存脑电文件；可回放、分析、生成报告；
使用结束：关闭软件，断电，清洁电极及配件。
医疗机构内经培训专业医技人员操作。
English
Equipment setup: Connect main unit, head‑box, medical power adapter and communication cables; launch acquisition software.
Place scalp electrodes following international 10‑20 system, apply conductive paste and fix electrodes.
Perｆorm impedance test; adjust electrodes until impedance meets qualified range.
Configure acquisition parameters (sampling rate, filter, sensitivity etc.) and start EEG recording.
Mark clinical events via event key if needed; perｆorm provocation test with optional photic stimulator.
Stop recording after acquisition, save EEG file. Playback, analyze and generate clinical reports.
Post‑use: Close software, power off device, clean electrodes and accessories.
To be operated only by trained professional clinical staff in medical institutions.
6. 适应症 Indications
中文适用于医疗机构临床人体脑电信号采集与监测；辅助用于癫痫筛查与分型、脑炎、脑损伤、意识障碍评估、睡眠障碍、重症脑功能监护等脑功能相关辅助诊断；本设备仅提供脑电原始数据，不独立作为确诊依据。
EnglishFor clinical acquisition and monitoring of human electroencephalogram signals in medical institutions. Assist in screening & classification of epilepsy, evaluation of encephalitis, brain injury, consciousness disturbance, sleep disorders and critical‑care cerebral‑function monitoring. The device only provides raw EEG data and shall not be solely used for final diagnosis.
7. 禁忌症 Contraindications
中文无绝对禁忌症；头皮大面积破溃、烧伤、感染部位禁止放置电极；对导电膏 / 电极材料过敏者禁止使用对应接触部件。
EnglishNo absolute contraindications. Do NOT place electrodes over extensive scalp laceration, burn or infected skin. Avoid corresponding contacting components for patients allergic to conductive paste or electrode materials.
8. 注意事项 Precautions
中文
本设备为 Ⅱ 类医用诊断设备，仅医疗机构、经培训人员使用，不可家用；
电极放置避开头皮伤口、炎症；必须做阻抗检测保证信号质量；
设备远离高频电刀、除颤仪等强电磁设备，减少干扰；除颤操作时应断开脑电采集连接；
使用原厂电源适配器、原厂配件，禁止非授权改装；
线缆避免挤压弯折，定期检查线缆绝缘破损；
不要在氧气富积环境使用；
数据仅作辅助诊断，临床需医师综合判读；
定期设备维护、质控校准，按说明书进行清洁消毒；
发生设备异常立即停止使用，断开电源，联系厂家售后。
English
Class II medical diagnostic device. For professional use in medical institutions only, not for home‑use.
Avoid placing electrodes over scalp wounds or inflamed skin. Perｆorm impedance check to guarantee signal quality.
Keep away from high‑frequency electrosurgical units and defibrillators to reduce interference. Disconnect EEG acquisition during defibrillation.
Use original manufacturer power adapter and accessories. Unauthorized modification is prohibited.
Prevent cables from squeezing or sharp bending; inspect insulation damage periodically.
Do not operate in oxygen‑enriched atmosphere.
Acquired data serves only as auxiliary reference; clinical interpretation shall be completed by physicians.
Perｆorm regular maintenance and quality‑control calibration; clean and disinfect per IFU.
Stop operation immediately upon device abnormality, cut off power and contact manufacturer service.
9. 存储条件 Storage Conditions
中文存储温度：‑10 ℃～55 ℃；相对湿度：20%～80% RH；无冷凝；通风干燥，避免阳光直射、粉尘、腐蚀性气体；线缆、头盒、电极配件分类存放。
EnglishStorage Temperature: ‑10 ℃～55 ℃; Relative Humidity: 20%‑80% RH, non‑condensing. Store in well‑ventilated dry place, avoid direct sunlight, dust and corrosive gas. Store cables, head‑box and electrode accessories separately.
10. 说明书核心摘要 IFU Core Summary
中文
产品名称：数字脑电图机；型号：NSE1、NSE2、NSE3；注册证苏械注准 20242071633；Ⅱ 类医疗器械。
组成：脑电采集部分（主机、头盒、线缆、医用电源、事件按键、网线）；选配闪光刺激器；软件 V1。
预期用途：临床脑电信号采集和监测，辅助临床评估脑功能。
操作者：医疗机构经过专业培训的医师、技师。
安全标准：GB9706.1‑2020，YY9706.102‑2021。
警告：不可作为独立确诊工具；除颤前断开采集；禁止非原厂配件改装；定期质控校准。
维护：清洁消毒按照原厂 IFU；故障勿自行拆机，联系厂家。
English‑ Product Name: Digital Electroencephalograph; Models: NSE1, NSE2, NSE3; Registration No. Su‑Mei‑Zhu‑Zhun 20242071633, Class II medical device. ‑ Composition: EEG acquisition unit (main unit, head‑box, cables, medical power supply, event key, Ethernet cable); optional photic stimulator; Software V1. ‑ Intended Use: Clinical acquisition and monitoring of EEG signals for auxiliary cerebral‑function evaluation. ‑ Operator: professionally‑trained physicians and technicians within medical institutions. ‑ Safety Standards: GB9706.1‑2020, YY9706.102‑2021. ‑ Warnings: Not for standalone diagnosis. Disconnect acquisition before defibrillation. No unauthorized third‑party accessories or modification. Perｆorm periodic quality‑control calibration. ‑ Maintenance: Clean and disinfect in accordance with manufacturer IFU. Do not disassemble in case of malfunction; contact manufacturer support.
免责提示：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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