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厂家直供博睿康数字脑电图机NSP1s,NSP2s,NSP3s
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厂家直供博睿康数字脑电图机NSP1s,NSP2s,NSP3s
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
NSP1s、NSP2s、NSP3s、NSP4s、NSP5s、NSP6s
结构及组成/主要组成成分
见产品主要结构及组成附件
适用范围/预期用途
适用于临床脑电信号的采集和监测，以及事件相关脑功能辅助检查，在医疗机构中使用。不包含自动诊
断功能。
产品储存条件及有效期
1、工作原理 Working Principle
中文本设备属于生物电放大采集设备。头皮电极拾取大脑产生的微弱脑电生物电信号，传输至采集头盒完成信号放大、滤波，经模数转换将模拟生物电转为数字信号；主机与软件对数字脑电信号做运算处理、实时显示、存储、回放；可同步接入选配闪光刺激、事件标记信号，实现临床脑电记录与事件相关脑功能检查；设备无自动诊断功能，需医师判读波形。
EnglishThis device is a bio‑electric amplifier and acquisition system. Scalp electrodes pick up faint electrophysiological signals generated by the brain. The signals are transmitted to the head‑box for amplification and filtering, then converted from analog to digital data via A/D converter. The host unit and software process, display in real‑time, store and replay digital EEG data. Optional photic stimulation and event marker signals can be synchronized for clinical EEG recording and event‑related brain function auxiliary examination. No automatic diagnosis function; waveｆorms must be interpreted by qualified physicians.
2、产品功能 Functions
中文
多通道脑电信号实时采集、波形显示、记录存储；
电极阻抗实时检测，评估信号采集质量；
脑电波形回放、标尺调节、导联组切换、波形测量标注；
支持振幅整合脑电图 aEEG、频段功率趋势、时频分析；
选配：闪光刺激诱发试验、事件按键标记、同步视频录像；
原始脑电导出、报告编辑打印，用于医师人工判读；
事件相关脑功能辅助检查；无自动诊断输出。
English
Multi‑channel real‑time EEG acquisition, waveｆorm display, recording & storage.
Real‑time electrode impedance detection for signal quality evaluation.
EEG replay, scale adjustment, montage switching, waveｆorm measurement & annotation.
Support aEEG (amplitude‑integrated EEG), band‑power trend, time‑frequency analysis.
Optional: photic‑stimulation provocation test, event trigger marker, synchronized video recording.
Raw EEG data export, report editing and printing for physician manual interpretation.
Auxiliary examination for event‑related brain function. No automatic diagnostic output.
3、产品特点 Product Features
中文
高共模抑制比，ICU、手术室强电磁干扰环境下仍可获得高质量脑电；
实时阻抗监控，快速定位电极接触不良问题；
兼顾常规诊断脑电与重症脑功能监护，同时输出原始 EEG 与脑功能趋势图；
模块化配置：NSP1s/NSP2s/NSP3s 通道数逐级递增，适配门诊、病房、ICU 不同场景；
支持长时程连续脑电记录；
兼容国际 10‑20 导联系统；
可选视频、闪光刺激等配件，扩展癫痫诱发、同步视像监测；
整机符合医用电气安全 GB9706 系列、电磁兼容 YY9706 系列标准。
English
High CMRR (Common‑Mode Rejection Ratio), delivers high‑quality EEG under heavy EMI in ICU and operating room.
Real‑time impedance monitoring to quickly identify poor electrode contact.
For both routine diagnostic EEG and intensive‑care brain‑function monitoring; outputs raw EEG and brain‑function trend graph simultaneously.
Modular configuration: NSP1s / NSP2s / NSP3s with incremental channels, suitable for outpatient, ward and ICU.
Support long‑term continuous EEG recording.
Compliant with International 10‑20 Electrode Placement System.
Optional accessories: video module, photic stimulator for epilepsy provocation and synchronized video monitoring.
Comply with medical electrical safety GB9706 series and EMC YY9706 series standards.
4、技术参数 Technical Specifications
NSP1s / NSP2s / NSP3s 差异主要为最大采集通道数；电气性能指标一致。
表格
| 中文 | English |
|---|---|
| 型号：NSP1s、NSP2s、NSP3s | Model: NSP1s, NSP2s, NSP3s |
| 最大采集通道：NSP1s：16 导；NSP2s：32 导；NSP3s：48 导 | Max Channels: NSP1s:16ch；NSP2s:32ch；NSP3s:48ch |
| 模数转换分辨率：24 bit | A/D Resolution: 24‑bit |
| 共模抑制比：≥110 dB | CMRR: ≥110 dB |
| 输入阻抗：＞1 GΩ | Input Impedance: ＞1 GΩ |
| 采样率：≥500Hz（软件可配置） | Sampling Rate: ≥500Hz (software configurable) |
| 输入噪声：≤1µVrms (1‑100Hz) | Input Noise: ≤1µVrms (1‑100Hz) |
| 频率响应：0.01Hz‑1000Hz | Frequency Response: 0.01Hz‑1000Hz |
| 安全类型：医用 BF 型应用部分 | Safety Type: Medical BF applied part |
| 供电：医用安全电源适配器 | Power Supply: Medical safety power adapter |
| 选配组件：闪光刺激器、事件按键、视频采集模块 | Optional: Photic stimulator, event trigger key, video acquisition module |
| 软件版本：V1 | Software Version: V1 |
5、使用方法 Instructions for Use
中文
设备就位，连接主机、头盒、医用电源适配器、网线，开机自检；
按照国际 10‑20 系统在患者头皮安放脑电电极，电极线缆接至采集头盒；
软件进入阻抗检测界面，调节电极，使阻抗达到临床合格范围；
设置采集参数（采样率、导联、滤波参数）；按需连接选配闪光刺激器、事件按键、摄像头；
启动记录，实时观察脑电波形；执行诱发试验、标记临床事件；
记录完成，停止采集，保存病例文件；回放查看波形，进行测量标注，生成、打印检查报告；
检查结束，断电，拆卸电极线缆，清洁设备外部；原始数据归档保存；
本设备仅提供脑电记录，必须由执业医师判读结果，不可自动输出诊断结论。
English
Place the device, connect host unit, head‑box, medical power adapter and network cable. Power‑on and perｆorm self‑test.
Place scalp electrodes following International 10‑20 System; connect electrode cables to acquisition head‑box.
Enter impedance‑check interface in software. Adjust electrodes until impedance meets clinical acceptance criteria.
Configure acquisition parameters: sampling rate, montage, filter settings. Connect optional photic stimulator, event trigger and camera as needed.
Start recording and observe real‑time EEG waveｆorms. Perｆorm provocation tests and mark clinical events.
Stop acquisition after examination. Save patient file. Replay waveｆorms, perｆorm measurement & annotation, generate and print report.
Power off, disconnect electrode cables, clean device exterior. Archive raw data.
This device only records EEG data. Results shall be interpreted by licensed physicians; no automatic diagnostic conclusion shall be used.
6、适应症 Indications / Intended Use
中文适用于医疗机构内，对人体进行临床脑电信号采集、监测以及事件相关脑功能辅助检查；供神经内科、神经外科、ICU、NICU、癫痫中心、急诊门诊使用；用于获取脑电原始波形供医师评估脑功能、辅助癫痫及其他脑部疾患评估；无自动诊断功能。
EnglishIntended for acquisition and monitoring of human clinical EEG signals and auxiliary event‑related brain‑function examinations in medical institutions. Used in neurology, neurosurgery, ICU, NICU, epilepsy center and emergency outpatient department. Raw EEG waveｆorms are obtained for physicians to evaluate brain function and assist assessment of epilepsy and other cerebral disorders. No automatic diagnostic function.
7、禁忌症 Contraindications
注册资料未列明绝对禁忌症；为临床使用禁忌（源自脑电图临床通用规范）
中文
头皮检查部位存在大面积开放性伤口、严重烧烫伤、皮肤严重感染，无法正常安放电极；
患者情况不允许头皮接触电极（临床医师综合评估判定不能实施脑电图检查）；
不可直接用于颅内侵入式信号采集；仅用于头皮脑电记录。
English
Large open wounds, severe burn or severe skin infection on scalp where electrodes cannot be properly placed.
Patient condition, in physician’s overall assessment, renders scalp‑EEG examination inadvisable.
Not for invasive intracranial signal acquisition. Only for non‑invasive scalp EEG recording.
8、注意事项 Warnings & Cautions
中文
本设备仅在医疗机构由经培训的医务人员操作使用；
设备仅输出脑电原始数据，不能单独作为确诊依据，必须结合临床症状由医师综合判读；
电极、导电膏不属于本设备标配，选用医用脑电图专用耗材；
远离高频电刀、除颤仪等强干扰设备；除颤放电前建议断开采集电极连接；
不要对设备主机、头盒进行浸泡消毒；仅做外壳擦拭消毒；
定期做设备电气安全校验；
防止线缆挤压弯折损坏；
选配闪光刺激器时，对光敏感、光敏性癫痫患者严格遵照临床规范使用，防范诱发惊厥；
不可改装设备硬件与软件；软件版本不可随意篡改升级；
出现设备报错、波形异常，立即排查电极连接；故障无法排除停止使用，联系厂家维修。
English
This device shall be operated only by trained medical staff within medical institutions.
Only raw EEG data is provided. It cannot be used as sole diagnostic evidence. Clinical symptoms and physician comprehensive interpretation are mandatory.
Electrodes and conductive paste are not supplied with this device; use medical‑grade EEG consumables.
Keep away from high‑frequency electrosurgical unit, defibrillator and other strong EMI sources. Disconnect electrode connections before defibrillation discharge.
Do not immerse host unit or head‑box in liquid. Only perｆorm surface wiping disinfection.
Periodically perｆorm medical electrical‑safety verification.
Prevent cables from being squeezed, bent or damaged.
When using optional photic stimulator, strictly follow clinical protocol for photosensitive or photosensitive‑epilepsy patients to avoid convulsion provocation.
Hardware and software shall not be modified. Do not arbitrarily alter or upgrade software version.
If device error or abnormal waveｆorm occurs, check electrode connection immediately. Stop using if fault persists and contact manufacturer for service.
9、存储条件 Storage Conditions
中文环境温度：‑10℃～+55℃； 相对湿度：10%～80%，无冷凝； 大气压力：70kPa‑106kPa； 存放于干燥通风室内，避免阳光直射、粉尘、腐蚀性气体； 设备非灭菌产品，无需灭菌储存； 长期不使用应断电收纳，线缆整理防护，避免挤压磕碰。
EnglishAmbient Temperature: ‑10℃ ~ +55℃； Relative Humidity: 10%‑80%, non‑condensing； Atmospheric Pressure: 70kPa‑106kPa； Store in dry and ventilated indoor area. Avoid direct sunlight, dust and corrosive gas. Non‑sterile device; sterile storage is not required. Power off for long‑term storage. Organize and protect cables, avoid squeezing and impact.
10、产品组成 Product Composition
中文由主机、采集头盒、头盒连接线缆、医用安全电源适配器、网线、数字脑电采集记录系统软件（V1）组成；闪光刺激器、事件按键、视频模块为选配件；脑电电极不属于本设备组成。
EnglishConsists of host unit, acquisition head‑box, head‑box connecting cable, medical safety power adapter, network cable and Digital EEG Acquisition & Recording System Software (V1). Photic stimulator, event trigger key and video module are optional accessories. EEG electrodes are NOT part of this device.
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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