厂商直供诺诚数字化脑电图仪ND-E系列
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厂商直供诺诚数字化脑电图仪ND-E系列
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
ND-E100、ND-E200、ND-E300、ND-EV100、ND-EV200、ND-EV300
结构及组成/主要组成成分
见附件。
适用范围/预期用途
供医疗机构用于人体脑电生理信号记录、回放、数据处理，以及测量在声、光刺激诱发下的大脑生物电位，供专业医师对患者进行大脑认知功能的辅助诊断。该产品不具有自动诊断功能。
1 工作原理 Working Principle
中文： 通过放置于患者头皮的电极采集大脑神经元活动产生的微弱脑电生物电位信号；脑电放大器对微弱模拟信号进行放大、滤波、模数转换；经无线 / 有线传输至主机计算机，由软件完成信号接收、数字化处理、波形显示、存储、回放与分析；可同步采集声光刺激诱发产生的脑电诱发电位，输出脑电原始波形及衍生分析图谱，为医师提供脑功能辅助诊断依据，设备无自动诊断功能。
English： Weak bio‑electric potentials generated by cerebral neuron activities are collected via scalp electrodes. The EEG amplifier amplifies, filters and perｆorms analog‑to‑digital conversion for analog signals. Digitized data is transmitted (wired/wireless) to host computer. Software realizes signal reception, processing, waveｆorm display, storage, playback and analysis. Evoked brain potentials triggered by acoustic‑photic stimulation can be acquired synchronously. Raw EEG waveｆorms and derived analytical maps are provided for physicians for auxiliary brain‑function diagnosis. This device has no automatic diagnostic function.
2 产品功能 Product Functions
中文
脑电生理信号实时采集、显示、记录、存储、回放；
支持单极、双极、平均参考、自定义导联组态编辑；
头皮电极阻抗实时检测；
声光诱发刺激同步采集；支持睁闭眼、过度换气、闪光刺激等诱发试验事件标记；
脑电地形图、频谱分析、趋势分析；
棘波等病理波标记检索；
可选视频同步录制（EV 后缀型号）；
病例数据管理、报告生成、打印输出；
支持床旁、长时间脑电记录。
English
Real‑time acquisition, display, recording, storage and playback of EEG physiological signals.
Support montage editing: unipolar, bipolar, average reference and user‑defined montages.
Real‑time scalp‑electrode impedance test.
Synchronized acquisition under acoustic‑photic evoked stimulation; event marking for activation tests: eyes‑open/eyes‑closed, hyperventilation, photic stimulation.
EEG topographic mapping, spectral analysis and trend analysis.
Marking and retrieval of pathological waveｆorms such as spikes.
Optional synchronized video recording (models with suffix EV).
Patient data management, report generation and print‑out.
Support bedside and long‑term EEG recording.
3 产品特点 Product Features
中文
二类医用数字化脑电图系统，脑电放大盒隔离直流供电，降低工频干扰；
无线数据传输，减少线缆束缚，适配普通病房无需强制屏蔽室；
24‑32 通道配置，可扩展蝶骨电极、心电、肌电辅助通道；
阻抗可视化检测，快速判断电极接触质量；
一体化软件平台，常规脑电、脑电地形图集成于同一主机；
EV 型号集成视频脑电同步；
支持床旁急诊、脑死亡评估检查；
病例高速导出，便于归档与回顾分析；
兼容闪光刺激器等选配外设。
English
Class‑II medical digital EEG system. Isolated DC power supply for amplifier box to reduce power‑line interference.
Wireless data transmission reduces cable restraints; works in general wards without mandatory shielded room.
24‑32 channel configuration, expandable for sphenoidal electrodes, ECG, EMG auxiliary channels.
Visual impedance monitoring for quick evaluation of electrode contact quality.
Integrated software platｆorm: routine EEG and brain topographic mapping on one host.
EV models support synchronized video‑EEG.
Applicable for bedside emergency examination and brain death assessment.
High‑speed case export for archiving and retrospective review.
Compatible with optional accessories such as photic stimulator.
4 主要技术参数 Main Technical Specifications
中文
通道数：24～32 通道（依型号）；
定标电压：50 µV，误差≤±5%；
输入噪声：≤0.4 µVrms（0.5Hz‑30Hz）；
共模抑制比：≥110 dB；
时间常数：0.03 s、0.1 s、0.2 s、0.3 s；
幅频特性：0.5 Hz‑60 Hz；
采样率：最高≥1000 Hz；
电压灵敏度档位：25 µV/cm、50 µV/cm、100 µV/cm、200 µV/cm，误差≤±5%；
供电：放大器锂电池隔离直流供电；主机医用计算机交流供电；
传输方式：无线 WIFI；
软件版本：ND‑E 配套软件 V2 系列。
English
Channels: 24～32 (model‑dependent).
Calibration voltage: 50 µV, tolerance ≤±5%.
Input noise: ≤0.4 µVrms (0.5Hz‑30Hz).
Common‑mode rejection ratio: ≥110 dB.
Time constants: 0.03 s, 0.1 s, 0.2 s, 0.3 s.
Amplitude‑frequency characteristic: 0.5 Hz‑60 Hz.
Sampling rate: up to ≥1000 Hz.
Sensitivity settings: 25 µV/cm, 50 µV/cm, 100 µV/cm, 200 µV/cm; tolerance ≤±5%.
Power supply: Lithium‑battery isolated DC for amplifier; AC mains for host medical PC.
Data transmission: Wireless WIFI.
Software version: ND‑E bundled software V2 series.
5 使用方法 Operating Method
中文
准备：检查设备、放大器、电极线、电极、刺激配件完好；开启主机与脑电放大盒电源；
按国际 10‑20 系统规范在患者头皮安置脑电电极，做皮肤预处理；
软件进入阻抗测试，确认各通道阻抗达标；
新建病例，录入患者信息，选择导联方案；
启动采集，进行常规记录，按需执行睁闭眼、过度换气、闪光诱发等激活试验，标记事件；EV 型号开启同步视频；
完成采集后停止记录，保存病例文件；
回放浏览波形，执行地形图、频谱分析；编辑并生成诊断报告，打印；
关机，拆卸电极，清洁电极及配件，收纳设备。
提示：本设备必须由经过脑电图专业培训的医务人员操作。
English
Preparation: Inspect device, amplifier, electrode cables, electrodes and stimulation accessories. Power‑on host PC and EEG amplifier box.
Place scalp electrodes following International 10‑20 System, perｆorm skin pre‑treatment.
Run impedance test in software; ensure impedance of all channels meets requirements.
Create new patient case, input demographic inｆormation and select montage scheme.
Start acquisition for routine recording. Perｆorm activation tests as required: eyes‑open/closed, hyperventilation, photic stimulation; mark clinical events. Turn on synchronized video for EV models.
Stop recording after examination and save case file.
Review waveｆorms offline, perｆorm topographic & spectral analysis. Compile and print examination report.
Power‑off system, remove electrodes, clean accessories and store equipment.
Note: This equipment shall only be operated by medical staff with professional EEG training.
6 适应症 Indications
中文供医疗机构用于人体脑电生理信号记录、回放、数据处理，测量声光刺激诱发下大脑生物电位，辅助专业医师开展大脑脑功能评估；适用于癫痫筛查与发作监测、脑功能障碍评估、床旁脑功能评估、脑死亡辅助判定、各类脑病脑电检查；不具备自动诊断功能。
EnglishIntended for medical institutions to record, replay and process human EEG physiological signals, measure cerebral bio‑potentials induced by acoustic‑photic stimuli, assisting physicians in cerebral‑function evaluation. Clinical scenarios include epilepsy screening & seizure monitoring, cerebral dysfunction assessment, bedside brain‑function evaluation, auxiliary brain‑death evaluation and EEG examination for various encephalopathies. No automatic diagnostic function is provided.
7 禁忌症 Contraindications
中文
头皮大面积破损、烧伤、严重皮肤病，无法安全安放电极者，禁止头皮电极安置检查；
患者病情危重不能配合诱发试验（过度换气、闪光刺激）时，禁止实施对应诱发激活操作，但仍可做基础脑电记录；
无绝对全身禁忌症；检查属于体表电生理采集，不对人体施加治疗刺激。
English
Do not apply scalp electrodes for subjects with extensive scalp laceration, burn or severe dermatosis preventing safe electrode placement.
Activation tests (hyperventilation, photic stimulation) are contraindicated for critically‑ill patients unable to cooperate; basic EEG recording may still be perｆormed.
No absolute systemic contraindications. This is non‑invasive surface electrophysiological acquisition and delivers no therapeutic stimulation to human body.
8 注意事项 Precautions
中文
仅可由具备资质医疗机构、经专业培训人员操作；设备仅用于辅助诊断，最终诊断必须由执业医师综合临床得出，不可仅依赖设备输出结果；
电极安放前头皮做好清洁，保证阻抗合格，减少伪差；
闪光刺激、过度换气诱发试验需评估患者风险，癫痫高危患者诱发试验谨慎执行；
脑电放大器采用隔离供电，但设备不可与高频手术设备、除颤电极共用患者回路；
定期校验定标电压、噪声、共模抑制比等技术指标；
电极、电极线缆避免弯折磨损；保持配件清洁；
设备运行环境远离强电磁干扰源；
锂电池仅使用原厂适配充电器充电，禁止改装电池；
数据定期备份，防止病例丢失；
维修维护仅允许原厂或授权服务商实施，禁止自行拆机改造。
English
Operation limited to qualified medical institutions and professionally‑trained personnel. The device is for auxiliary diagnosis only. Final clinical diagnosis shall be made by licensed physicians integrating overall clinical inｆormation; do not rely solely on device output.
Clean scalp before electrode placement to achieve qualified impedance and minimize artifacts.
Assess risk before photic stimulation / hyperventilation activation tests; use caution for high‑risk epilepsy patients.
EEG amplifier adopts isolated power supply. Do NOT share patient circuit with high‑frequency surgical equipment or defibrillator electrodes.
Periodically calibrate technical indexes including calibration voltage, noise and CMRR.
Avoid sharp bending or abrasion of electrodes and cables; keep accessories clean.
Operate away from strong electromagnetic interference sources.
Charge lithium battery only with original matching charger; battery modification is prohibited.
Perｆorm regular data backup to prevent case‑data loss.
Service & repair shall be perｆormed only by manufacturer or authorized service provider. Disassembly or modification by end‑user is forbidden.
9 存储条件 Storage Conditions
中文环境温度：‑10 ℃～+45 ℃； 相对湿度：10%～80%，无冷凝； 大气压力：70 kPa‑106 kPa； 存放于干燥通风室内，避免阳光直射、粉尘、腐蚀性气体； 放大器锂电池长期存储时保持 50% 左右电量，定期补电。
EnglishAmbient temperature: ‑10 ℃～+45 ℃; Relative humidity: 10%‑80%, non‑condensing; Atmospheric pressure: 70 kPa‑106 kPa; Store in dry and ventilated indoor environment. Keep away from direct sunlight, dust and corrosive gas. Maintain lithium‑battery capacity at about 50% for long‑term storage; recharge periodically.
10 说明书核心摘要 Core IFU Summary
中文本产品为第二类医疗器械数字化脑电图仪，型号 ND‑E 系列；组成：脑电放大盒、电极线缆、隔离锂电池电源、无线通讯模块、医用计算机、显示器、打印机、软件；EV 型号增加视频摄像组件。预期用途：医疗机构采集记录、回放处理人脑电生理信号，声光诱发电位测量，医师脑功能辅助诊断，无自动诊断。操作要点：严格执行 10‑20 电极系统，阻抗合格后方可采集；诱发试验评估临床风险；隔离供电，避免与手术 / 除颤设备共患者回路；存储温湿度如上；操作人员须经脑电图专业培训；最终诊断由临床医师判定；维修由授权服务商执行。
EnglishCore IFU Summary: This is Class‑II medical device: ND‑E series digital electroencephalograph. System composition: EEG amplifier box, electrode cables, isolated lithium‑battery power unit, wireless communication module, medical PC, monitor, printer and software. EV models add video camera assembly. Intended use: For medical institutions to record, replay and process human EEG signals and acoustic‑photic evoked potentials for physician‑led auxiliary brain‑function assessment. No automatic diagnosis function. Key operation: Follow 10‑20 electrode placement standard; start acquisition only after qualified impedance. Evaluate clinical risk before activation tests. Isolated power supply; avoid shared patient circuit with surgical / defibrillator devices. Storage temperature‑humidity as above. Operators must receive specialized EEG training. Final diagnosis shall be made by clinician. Maintenance shall be completed by authorized service provider.
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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