厂商直供澳大利亚康迪脑电图机Neuvo
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厂商直供澳大利亚康迪脑电图机Neuvo
桂经理19117326863微xin同号
管理类别
第二类
型号规格
Neuvo
结构及组成/主要组成成分
该产品由系统单元、放大器、加密狗和工作站软件（Profusion EEG，V5.0）组成。
适用范围/预期用途
该产品临床用于记录、显示及存储脑电信号。
一、工作原理（Working Principle）
中文
Neuvo 是一款基于 SynAmps2 科研级放大器 技术平台的全数字化高密度脑电图采集系统，专为临床长时程监测（LTM）与科研设计。
信号采集：通过按国际 10-20 系统安放的高密度 Ag/AgCl 电极，捕捉大脑皮层自发或诱发的微伏级脑电（EEG）信号，并同步采集眼电（EOG）、肌电（EMG）、心电（ECG）等参考信号。
前端放大：信号经 轻量化无源头盒（Passive Headbox） 直接前置放大，最大限度缩短传输距离，降低信号衰减与外界干扰。
主动降噪：内置 主动噪声消除（Active Noise Cancellation） 技术，结合 50/60Hz 工频陷波，有效抑制环境电磁干扰与运动伪迹。
模数转换：采用 24 位高分辨率 A/D 转换器，将模拟信号转为数字信号，全通道同步采样，最高达 20,000Hz / 导，无失真还原 DC 至 3500Hz 超宽频信号。
数据处理：通过以太网高速传输至主机，由 ProFusion EEG 5 软件实现实时显示、阻抗监测、长时录像、自动分析及报告生成。
English
The Neuvo is a fully digital, high-density EEG acquisition system built on the SynAmps2 research-grade amplifier platｆorm, designed for clinical Long-Term Monitoring (LTM) and research.
Signal Acquisition: Captures microvolt-level EEG via high-density Ag/AgCl electrodes (10–20 system), synchronously with EOG, EMG, ECG reference signals.
Front-End Amplification: Lightweight passive headbox pre-amplifies signals directly at the source to minimize attenuation and interference.
Active Noise Cancellation: Integrated ANC + 50/60Hz notch filtering suppresses EMI and motion artifacts.
A/D Conversion: 24-bit high-resolution ADC; fully synchronous sampling up to 20,000Hz/channel for distortion-free DC–3500Hz wideband recording.
Data Processing: Ethernet transmission to host PC; ProFusion EEG 5 software enables real-time display, impedance check, video LTM, auto-analysis, and reporting.
二、产品功能（Functions）
中文
高密度多通道记录：标配 64/128/256 通道，可扩展至 512 通道，满足全脑、癫痫术前评估等高密度监测需求。
长时程视频脑电图（LTM）：支持 数小时至数天 连续监测，同步高清视频，定位癫痫发作起源。
多模态信号同步：同步采集 EEG/EOG/EMG/ECG/SpO?/ 呼吸，兼容颅内电极、栅格电极、深部电极记录。
实时阻抗监测：头盒端直接测量电极阻抗（1kΩ–50kΩ），实时显示，确保信号质量。
诱发 / 事件相关电位（EP/ERP）：支持 听 / 视 / 体感 刺激，记录 BAEP、VEP、SEP 及 P300 等认知电位Compumedics Neuroscan。
智能分析与源定位：自动 癫痫样放电检测、睡眠分期、伪迹剔除；结合 CURRY 软件 实现偶极子源定位、脑功能成像。
一体化监控控制：中央控制盒集成 闪光刺激、事件按钮、高清摄像头、麦克风 等外设。
数据安全与共享：支持 EDF/BDF/DICOM 格式，HIS/LIS/PACS 系统对接，数据加密、审计追踪。
English
High-Density Channel Recording: Standard 64/128/256 channels, expandable to 512 channels for full-brain and pre-surgical epilepsy mapping.
Long-Term Video-EEG (LTM): Continuous monitoring (hours–days) with synchronized HD video for precise seizure onset localization.
Multi-Modal Sync: Simultaneous EEG/EOG/EMG/ECG/SpO?/Respiration; compatible with intracranial, grid, and depth electrodes.
Real-Time Impedance: Headbox-side measurement (1kΩ–50kΩ) with live display for quality assurance.
Evoked Potentials (EP/ERP): Supports auditory/visual/somatosensory stimuli for BAEP, VEP, SEP, and cognitive potentials (e.g., P300)Compumedics Neuroscan.
Intelligent Analysis & Source Localization: Auto epileptiｆorm detection, sleep staging, artifact rejection; CURRY software for dipole localization and neuroimaging.
Integrated Control Box: Centralized control for photic stimulator, event button, HD camera, microphone.
Data Security & Sharing: EDF/BDF/DICOM compliant; HIS/LIS/PACS integration; encrypted storage & audit trails.
三、产品特点（Product Features）
中文
信号质量：24 位分辨率、>10GΩ 输入阻抗、>110dB 共模抑制比、<0.5µV 输入噪声，捕捉极微弱脑电信号。
模块化高密度扩展：64 通道头盒为基本单元，单系统可串联 4 个头盒，最高 512 通道 全同步采集Compumedics Neuroscan。
超宽频与高采样：DC ~ 3500Hz 带宽，覆盖从直流慢波到高频振荡（HFO）；最高 20,000Hz / 导 采样率。
无源轻量化头盒：64 通道无源头盒，无内置电路、重量极轻，患者佩戴舒适，减少运动伪迹。
主动降噪技术： Active Noise Cancellation，大幅提升抗干扰能力，记录更纯净。
临床科研双平台：既可用于 癫痫长时监测、术前评估 等临床，也支持 认知科学、BCI 等科研。
医用级安全合规：通过 FDA 510(k)、CE IIa、ISO 13485、IEC 60601 认证Compumedics Neuroscan。
极简线缆管理：单缆连接 设计，优化布线，减少干扰与安全隐患。
English
Superior Signal Fidelity: 24-bit resolution, >10GΩ input impedance, >110dB CMRR, <0.5µV input noise for ultra-weak signal detection.
Modular High-Density Scalability: 64-channel headbox building block; up to 4 headboxes (512 channels) fully synchronized per systemCompumedics Neuroscan.
Ultra-Wideband & High Sampling: DC–3500Hz bandwidth (DC to HFO); up to 20,000Hz/channel sampling.
Lightweight Passive Headbox: 64-channel passive design; no active circuitry, ultra-light, comfortable, minimal motion artifact.
Active Noise Cancellation: Exclusive ANC for superior interference rejection and cleaner recordings.
Dual Clinical/Research Platｆorm: For epilepsy LTM, pre-surgical evaluation (clinical) and cognitive neuroscience, BCI (research).
Medical Compliance: FDA 510(k), CE IIa, ISO 13485, IEC 60601 certifiedCompumedics Neuroscan.
Zero-Clutter Cable Management: Single-cable connection for simplified setup and reduced interference.
四、技术参数（Technical Specifications）
表格
参数项（Parameter） 规格（Specification） 英文（English）
品牌型号 康迪 Neuroscan Neuvo Compumedics Neuroscan Neuvo
通道配置 64/128/256/512 导（64 导 / 头盒） 64/128/256/512 ch (64 ch/Headbox)Compumedics Neuroscan
采样率 全通道同步，最高 20,000Hz / 导 Up to 20,000Hz/channel (all sync)
A/D 分辨率 24 位 24-bit
输入阻抗 > 10 GΩ > 10 GΩ
共模抑制比 > 110 dB > 110 dB
输入噪声 < 0.5 µV RMS (DC–200Hz) < 0.5 µV RMS (DC–200Hz)
信号带宽 DC ~ 3500 Hz DC ~ 3500 Hz
阻抗测量 1 kΩ ~ 50 kΩ（头盒直测） 1 kΩ – 50 kΩ (Headbox direct)
头盒类型 无源（Passive）64 通道 Passive 64-channel
数据接口 以太网（Ethernet） Ethernet
兼容软件 ProFusion EEG 5, Curry 9 ProFusion EEG 5, Curry 9
供电 100–240V AC, 50/60Hz 100–240V AC, 50/60Hz
认证标准 FDA 510(k), CE IIa, ISO 13485 FDA 510(k), CE IIa, ISO 13485Compumedics Neuroscan
注册证号 国械注进 20152073889 CFDI 20152073889
五、使用方法（Operation Method）
中文
术前准备
设备检查：连接头盒、主机、控制盒，开机自检，确认 ProFusion EEG 软件正常。
患者准备：清洁头皮去油脂，按 10-20 系统 安放电极帽，涂导电膏，固定导联线。
阻抗测试：启动软件阻抗检测，确保 所有电极阻抗 < 5kΩ（最佳 < 2kΩ）。
参数设置
选择监测模式（常规 EEG / 长时 LTM / 诱发电位）。
设置 采样率、滤波范围、记录时长、视频参数。
配置 参考电极、事件标记、报警阈值。
数据采集
常规 EEG：嘱患者闭目放松，记录 20–30 分钟 静息态，完成 睁闭眼、过度换气、闪光刺激 诱发试验。
长时 LTM：启动连续记录，开启同步视频，技师远程监控信号与患者状态。
分析与报告
导入数据，自动伪迹剔除、癫痫波检测、睡眠分期。
人工复核，标记异常波形，生成 频谱、地形图、源定位 结果。
导出 EDF 数据 + PDF 诊断报告，电子签名归档。
术后清洁
取下电极帽，75% 酒精 清洁头皮与设备表面，线缆整理收纳。
English
Pre-Study Preparation
Device Check: Connect headbox, host, control box; power-on self-test; verify ProFusion EEG software.
Patient Prep: Clean scalp; apply electrode cap per 10–20 system; apply conductive gel.
Impedance Check: Ensure all electrodes < 5kΩ (ideal < 2kΩ) via software.
Parameter Setup
Select mode (Routine EEG / LTM / Evoked Potentials).
Set sampling rate, filters, duration, video settings.
Configure reference, event markers, alarm thresholds.
Data Acquisition
Routine EEG: Patient rests eyes closed; record 20–30 min; perｆorm activation procedures.
Long-Term LTM: Start continuous recording; enable synchronized video; remote monitoring.
Analysis & Reporting
Import data; auto artifact rejection, spike detection, sleep staging.
Manual review; mark abnormalities; generate spectra, topography, source localization.
Export EDF + PDF report; electronic signature & archive.
Cleanup
Remove cap; clean scalp & device with 75% alcohol; store cables.
六、适应症（Indications）
中文
癫痫：诊断、分型、致痫灶定位、术前评估、术后疗效监测、长时程发作监测。
中枢神经系统感染：脑炎、脑膜炎、克雅病（CJD） 脑功能评估。
脑血管病：脑梗死、脑出血、TIA、血管性痴呆 脑电异常与预后判断。
脑肿瘤 / 外伤：颅内占位、脑损伤 功能区定位与损伤程度评估。
意识障碍：昏迷、植物状态、脑死亡 客观电生理判定。
睡眠障碍：失眠、发作性睡病、异态睡眠 脑电结构分析。
代谢 / 中毒性脑病：肝性脑病、肾性脑病、药物中毒 脑功能监测。
儿科神经疾病：发育迟缓、惊厥、脑瘫、儿童癫痫 早期诊断。
精神疾病：器质性与功能性精神病鉴别、精神药物疗效评估。
English
Epilepsy: Diagnosis, classification, focus localization, pre-surgical evaluation, post-op monitoring, LTM.
CNS Infections: Encephalitis, meningitis, CJD brain function assessment.
Cerebrovascular Disease: Stroke, TIA, vascular dementia abnormality & prognosis.
Tumor/Trauma: Intracranial mass, brain injury functional mapping & severity.
Consciousness Disorders: Coma, vegetative state, brain death electrophysiological confirmation.
Sleep Disorders: Insomnia, narcolepsy, parasomnia architecture analysis.
Metabolic/Toxic Encephalopathy: Hepatic, uremic, drug intoxication monitoring.
Pediatric Neurology: Developmental delay, seizures, CP, childhood epilepsy early diagnosis.
Psychiatry: Organic vs. functional psychosis, psychotropic drug evaluation.
七、禁忌症（Contraindications）
中文
绝对禁忌
头皮大面积感染、破损、开放性创伤（电极无法固定、感染风险）。
对导电膏 / 电极胶严重过敏（接触性皮炎、过敏性休克）。
生命体征极不稳定、需紧急抢救（干扰急救、无诊断价值）。
相对禁忌（慎用）
颅骨缺损、开颅术后早期（信号失真、定位误差）。
严重凝血障碍、出血倾向（皮肤损伤出血风险）。
精神躁动、不合作、无法耐受（需镇静后进行）。
皮肤湿疹、银屑病急性期（电极接触不良、刺激加重）。
English
Absolute Contraindications
Extensive scalp infection, wounds, open sores (poor adhesion, infection risk).
Severe allergy to conductive gel/paste (dermatitis, anaphylaxis).
Hemodynamically unstable, emergency resuscitation (interferes with care).
Relative Contraindications (Caution)
Skull defects, early post-craniotomy (signal distortion, localization error).
Severe coagulopathy, bleeding tendency (skin injury risk).
Agitation, uncooperative, intolerant (sedation required).
Acute eczema, psoriasis (poor contact, irritation).
八、注意事项（Precautions）
中文
检查前
患者 洗净头发、停用发胶 / 护发素，勿空腹（防低血糖）。
不停用抗癫痫药（医嘱除外），防诱发发作。
设备 远离电磁干扰（手机、WiFi、微波炉），确保接地良好。
检查中
患者 保持安静、少动、不眨眼，技师实时监控阻抗与信号。
严禁擅自修改参数、删除数据，异常事件立即标记。
诱发试验 严格控制刺激量，观察患者反应，不适即停。
检查后
数据立即备份、加密存储，防止丢失 / 篡改。
电极 / 头盒 清洁消毒，避免交叉感染。
定期 设备校准、性能质控、软件升级，保存维护记录。
English
Before Exam
Patient shampoo hair, no gel/conditioner; avoid fasting (hypoglycemia).
Do NOT stop AEDs (unless ordered) to prevent seizures.
Keep device away from EMI (phones, WiFi, microwave); good grounding.
During Exam
Patient stay still, quiet, minimal eye blinks; monitor impedance/signals.
Do NOT alter settings/delete data; mark abnormal events immediately.
Control activation intensity; stop if patient distressed.
After Exam
Backup & encrypt data immediately to prevent loss/tampering.
Clean/disinfect electrodes/headbox to avoid cross-infection.
Regular calibration, QA, software updates; maintain logs.
九、存储条件（Storage Conditions）
中文
主机 / 头盒
温度：-20℃ ~ +50℃
湿度：30% ~ 95% RH（无冷凝）
环境：干燥、通风、避光、防尘、防电磁干扰、防挤压。
电极 / 线缆
清洁干燥、单独存放、防弯折、防老化；定期更换老化配件。
软件与数据
服务器：15℃ ~ 25℃、40% ~ 60% RH、防静电、防雷。
数据：企业级存储、RAID 冗余、异地备份、保存≥15 年（医疗法规）。
English
Device/Headbox
Temperature: -20°C to +50°C
Humidity: 30–95%RH (non-condensing)
Environment: Dry, ventilated, dark, dust/EMI/shock protected.
Electrodes/Cables
Clean, dry, separate storage; avoid bending/aging; replace worn parts regularly.
Software/Data
Server: 15–25°C, 40–60%RH, ESD/lightning protected.
Data: Enterprise storage, RAID, offsite backup, retain ≥15 years (regulations).
十、说明书核心信息（Manual Core Inｆormation）
中文
产品名称：Neuvo 高清视频脑电图仪
型号：Neuvo 64 / 128 / 256 / 512
制造商：Compumedics USA, Inc.（澳大利亚康迪）
注册证号：国械注进 20152073889
预期用途：临床与科研用脑电图（EEG）、长时视频监测（LTM）、诱发电位（EP/ERP）记录与分析
核心组件：无源头盒、系统主机、ProFusion EEG 5 采集软件、CURRY 9 分析软件、中央控制盒
安全声明
经培训的医师 / 技师操作。
严格遵守适应症 / 禁忌症，过敏 / 感染患者禁用。
定期校准质控，确保数据准确。
数据不可篡改、加密归档，符合医疗法规。
远离电磁干扰，保证信号质量。
使用后清洁消毒，预防交叉感染。
English
Product Name: Neuvo HD Video-EEG System
Model: Neuvo 64 / 128 / 256 / 512
Manufacturer: Compumedics USA, Inc. (Australia)
Registration: CFDI 20152073889
Intended Use: Clinical & research EEG, video-LTM, EP/ERP recording & analysis
Core Components: Passive Headbox, Main Unit, ProFusion EEG 5, CURRY 9, Control Box
Safety Statements
For trained physicians/technologists only.
Follow indications/contraindications; no use on allergic/infected patients.
Regular calibration & QA for accuracy.
Data immutable, encrypted, compliant with regulations.
Avoid EMI for signal integrity.
Clean/disinfect after use to prevent cross-infection.
Shanghai Kangshida Medical Devices Co., Ltd. is a professional company engaged in the sales of medical devices, focusing on the agency and distribution of renowned medical equipment brands from both domestic and international markets. Its core product range covers full-scenario medical devices for physical examination, diagnosis, emergency treatment, laboratory testing, ultrasound, medical analysis, life sciences, disinfection and sterilization, rehabilitation therapy, operating rooms, emergency rooms, consulting rooms and other fields. Relying on its strong product sales capacity, excellent commercial reputation and integrity-based operation philosophy, the company has won unanimous recognition and trust from medical institutions and partners.
The steady and rapid development of the company is attributed to its carefully selected high-quality product portfolio. It always takes customer needs as the core orientation and is committed to creating long-term value and practical benefits for customers. As an authorized and exclusive agent for many well-known domestic and international manufacturers, the company has established a complete supply system of medical devices with reliable quality, fully meeting the needs of clinical diagnosis and treatment.
The company always takes improving customer satisfaction as its core goal. To strictly adhere to product standards and exceed the expectations of customers and manufacturers, it regularly provides training on professional ethics and professional business skills, forging a highly competent, efficient and executive team covering business, technology and management. The team implements a 7×24-hour all-weather response mechanism to provide professional and high-quality after-sales service and technical support, efficiently solving various equipment operation and maintenance problems. At the same time, the company offers exclusive services including same-day delivery and free distribution, ｆorming a closed loop covering supply, distribution and after-sales service to fully ensure the stable supply and worry-free use of medical equipment for medical institutions.
Upholding integrity as the foundation of its business, the company selects high-quality medical devices and provides professional services for customers, helping to upgrade the quality of medical services and contributing to the high-quality development of China's medical industry.
Intellectual Property Infringement Complaint: Kangshida Medical does not manufacture medical products; all products are sourced from original manufacturers. We will promptly address any intellectual property infringement issues.The content published herein is for reference only.
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