厂商安迪特多导睡眠脑电记录仪ASE-2012
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厂商安迪特多导睡眠脑电记录仪ASE-2012
桂经理19117326863微xin同号
桂经理19117326863微xin同号
产品名称 多导睡眠脑电记录仪
管理类别 第二类
型号规格 ASE-2012
结构及组成/主要组成成分 由电源适配器、脑电放大器、胸腹呼吸传感器、电极导联线及终端软件组成。
适用范围/预期用途 本产品用于记录、显示、存储及打印患者睡眠过程中的脑电活动、胸腹呼吸参数。供医护人员分析、使用。不包含自动分析诊断功能。
中文名称：多导睡眠脑电记录仪English Name: Polysomnography Recorder粤械注准 20192071045型号：ASE-2012管理类别：Ⅱ 类有源医疗器械系统组成：脑电放大器、电源适配器、脑电导联电极线、胸腹呼吸传感器、终端分析软件；可选配眼电、肌电电极、同步摄像头⚠️重要说明：设备仅负责生理信号采集、存储、回放，无全自动智能诊断功能，所有波形必须由临床医师人工判读
一、工作原理 Working Principle
中文大脑神经元活动产生微伏级脑电生物电信号，通过头皮电极采集传输至低噪声差分前置放大器。设备依靠高输入阻抗、高共模抑制电路滤除工频干扰，对模拟脑电信号进行模数转换数字化采样；可同步采集眼电、下颌肌电、胸腹呼吸运动等睡眠相关生理信号。整夜连续采集原始生理波形并实时传输至计算机工作站存储；监测结束后软件完成波形回放、测量、频谱分析。结合脑电、眼动、肌电、呼吸波形区分清醒、浅睡眠、深睡眠、REM 快速眼动睡眠周期，识别呼吸暂停、低通气、睡眠期异常脑电波，为睡眠障碍、夜间癫痫提供客观电生理评估依据。
EnglishNeuronal activity generates microvolt-level EEG bioelectrical signals captured by scalp electrodes and delivered to low-noise differential pre-amplifier. High-input-impedance and high common-mode rejection circuits suppress power-line interference, while analog EEG signals undergo analog-to-digital conversion and digital sampling. The system synchronously acquires sleep-related physiological signals including EOG, submental EMG and thoracic-abdominal respiratory movement.Raw physiological waveｆorms are continuously recorded overnight and transmitted to workstation for storage. After monitoring, the software supports waveｆorm playback, measurement and spectral analysis. Combined EEG, EOG, EMG and respiratory traces distinguish wakefulness, light sleep, deep sleep and REM cycles, and identify apnea, hypopnea and sleep-related epileptiｆorm discharges, providing ｏbjective electrophysiological evidence for evaluation of sleep disorders and nocturnal epilepsy.
二、产品功能 Functions
中文
多通道同步采集脑电（EEG）、眼电（EOG）、下颌肌电（EMG）、胸腹呼吸信号；
支持整夜连续多导睡眠监测（PSG），兼容国际 10-20 电极安放标准；
实时电极阻抗检测、波形实时屏幕预览，支持手动事件标记；
原始数据无损保存，软件可调数字滤波、标尺测量、频谱分析；
波形自由滚动回放、通道独立显示开关，支持睡眠事件标注统计；
监测报告编辑、数据导出、波形打印；可选配同步视频记录区分运动伪迹；
USB 有线数据通讯，适配病房固定床位整夜睡眠监测。
English
Synchronous multi-channel acquisition of EEG, EOG, submental EMG and thoracic-abdominal respiratory signals;
Support overnight continuous polysomnography (PSG), compatible with International 10-20 electrode placement standard;
Real-time electrode impedance test, real-time waveｆorm preview and manual event marking;
Lossless raw data storage, adjustable digital filtering, cursor measurement and spectral analysis;
Scrollable waveｆorm playback, independent channel display toggle, annotation and statistics of sleep events;
Report editing, data export and waveｆorm printing; optional synchronized video recording to differentiate movement artifacts;
USB wired communication for fixed-bed overnight sleep monitoring in ward.
三、产品特点 Product Features
中文
稳定差分放大电路，具备良好病房抗干扰能力，适合夜间长时睡眠记录；
基础多导睡眠标准通道配置，满足基层医院睡眠呼吸疾病常规筛查需求；
原始采集波形完整留存，滤波仅为离线后处理，不会篡改原始采样数据；
实时阻抗监测，提前发现电极接触不良，降低无效监测概率；
配套软件操作简洁，波形布局贴合睡眠技师阅图习惯；
模块化传感器接口，安装便捷，兼容盘状头皮电极；
整机架构成熟，维护简单，适合睡眠初筛、常规整夜 PSG 监测场景。
English
Stable differential amplification circuit with reliable anti-interference perｆormance for overnight sleep recording;
Standard basic polysomnography channel configuration, meeting routine screening requirements for sleep-disordered breathing in primary hospitals;
Complete preservation of raw recorded waveｆorms; filtering is only offline post-processing without altering original sampled data;
Real-time impedance monitoring detects poor electrode contact in advance and reduces invalid recordings;
User-friendly software layout matching routine visual review workflow for sleep technologists;
Modular sensor ports for easy installation, compatible with disc scalp electrodes;
Mature system architecture with simple maintenance, suitable for sleep preliminary screening and standard overnight PSG.
四、技术参数 Technical Specifications
| 中文 | English |
|---|---|
| 产品型号：ASE-2012 | Model：ASE-2012 |
| 通道配置：12 通道基础睡眠配置（EEG+EOG+EMG + 呼吸） | Channel Configuration：12-channel basic sleep setup (EEG+EOG+EMG+Respiration) |
| 采样频率：250Hz | Sampling Frequency：250Hz |
| 输入阻抗：≥1GΩ | Input Impedance：≥1GΩ |
| 共模抑制比：＞100dB | CMRR：＞100dB |
| 采集带宽：0.1Hz～70Hz | Acquisition Bandwidth：0.1Hz～70Hz |
| 模数转换精度：16bit A/D | A/D Resolution：16 bit |
| 数据传输：USB 有线通讯 | Data Communication：USB wired transmission |
| 供电方式：AC 220V 50Hz 市电供电 | Power Supply：AC 220V 50Hz mains power |
| 运行环境温度：10℃～30℃ | Operating Ambient Temperature：10℃～30℃ |
| 可选配件：同步摄像头、盘状电极、导电膏 | Optional Accessories：Synchronized camera, disc electrodes, conductive paste |
| 整机预期使用寿命：5 年 | Expected Service Life：5 years |
五、使用方法 Operation Instructions
中文
放大器、计算机接通电源，开机完成硬件自检；按需连接摄像头；
按照国际 10-20 规范清洁受试者头皮，粘贴脑电、眼电、肌电电极，安置胸腹呼吸传感器；
软件启动阻抗检测，调整电极直至阻抗达标；建立患者档案，设置整夜采集参数；
正式启动同步记录；监测期间可手动标记憋气、肢体活动等临床事件；
整夜监测结束停止采集；拆除所有电极与传感器，清洁受试者皮肤；
软件回放原始波形，人工标注呼吸事件、睡眠分期，完成波形分析；
医师结合波形出具辅助评估报告；
设备关机，清洁导联线、传感器，规整收纳。
English
Power on amplifier and computer for hardware self-test; connect camera if required;
Clean subject scalp following 10-20 standard, attach EEG, EOG, EMG electrodes and install thoracic-abdominal respiration sensors;
Run impedance test on software and adjust electrodes until qualified; create patient profile and set overnight recording parameters;
Start synchronized recording; manually tag clinical events such as apnea and limb movement during monitoring;
Stop acquisition after overnight study; remove all electrodes and sensors and clean subject’s skin;
Play back raw waveｆorms in software, manually annotate respiratory events and complete sleep staging and waveｆorm analysis;
Qualified physicians issue auxiliary evaluation report based on all traces;
Power off equipment, clean cables and sensors before organized storage.
六、适应症 Indications
中文本产品用于睡眠过程中脑电、胸腹呼吸等生理信号采集、显示、存储与回放，辅助临床评估：
阻塞性睡眠呼吸暂停低通气综合征（OSAHS）筛查与病情评估；
不明原因日间嗜睡、晨起头痛、夜间憋闷病因鉴别；
失眠、不宁腿综合征等常见睡眠障碍初步筛查；
高度怀疑夜间发作癫痫，需捕捉睡眠期异常脑电活动；
脑血管疾病、轻度脑外伤患者睡眠脑功能基础评估。⚠️仅提供波形数据，不可单独作为确诊依据，必须由医师结合病史综合判断。
EnglishThis device acquires, displays, stores and replays physiological signals including EEG and respiration during sleep to assist clinical evaluation:
Screening and severity assessment of Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS);
Differential diagnosis of unexplained excessive daytime sleepiness, morning headache and nocturnal dyspnea;
Preliminary screening for insomnia, restless legs syndrome and other common sleep disorders;
Suspected nocturnal epilepsy requiring detection of sleep-related abnormal EEG discharges;
Basic sleep and brain function evaluation for patients with cerebrovascular disease and mild traumatic brain injury.⚠️ Only provides waveｆorm data and cannot be used as independent diagnostic evidence; comprehensive clinical judgment by physicians is required.
七、禁忌症 Contraindications
中文多导睡眠监测属于检查，设备无绝对禁忌症；下列情况为检查相对禁忌：
头皮大面积破损、活动性皮肤感染、严重皮肤病，无法粘贴电极；
患者重度躁动、精神行为异常，无法配合整夜佩戴各类传感器；
受试者对导电膏、电极材料存在明确严重接触性皮炎；
生命体征极不稳定危重症，不适合整夜卧床睡眠监测。
EnglishPolysomnography is non-invasive; the equipment has no absolute contraindications. The following are relative contraindications for testing:
Extensive scalp wounds, active skin infection or severe dermatitis preventing electrode attachment;
Severely agitated patients unable to tolerate overnight sensor placement;
Confirmed severe contact dermatitis to conductive paste or electrode materials;
Critically ill patients with unstable vital signs unsuitable for overnight in-bed sleep monitoring.
八、注意事项 Precautions
中文
操作人员需接受睡眠脑电规范化培训，掌握电极安放、伪迹识别基础技能；
监测前充分清洁头皮油脂，电极阻抗过高极易产生大量运动伪迹，影响波形判读；
监测环境保持安静、光线柔和，提醒受试者避免大幅度翻身拉扯导联；
放大器远离高频电刀、呼吸机等电磁干扰设备，规范做好接地；
严禁液体泼洒进入放大器主机内部，防止硬件短路损坏；
妥善保存患者睡眠原始数据，严格遵守医疗信息隐私保护相关法规；
导联线、传感器避免长期弯折老化；每位受试者更换导电耗材，定期清洁消毒；
定期开展设备阻抗校准与功能自检；波形出现持续异常时立即停机报修；
本设备仅为诊断信号采集设备，不具备任何治疗功能。
English
Operators must receive standardized training on sleep EEG, electrode placement and artifact recognition;
Thoroughly remove scalp sebum before recording; excessive electrode impedance causes massive motion artifacts interfering with interpretation;
Maintain quiet, dim monitoring environment; instruct subjects to avoid violent rolling and cable pulling;
Keep amplifier away from electrosurgical units, ventilators and other EMI sources with proper grounding;
Prevent liquid spillage into amplifier chassis to avoid short-circuit damage;
Securely archive patient raw sleep data and comply with medical privacy regulations;
Avoid permanent bending of cables and sensors; replace conductive consumables for each patient and implement regular disinfection;
Perｆorm periodic impedance calibration and function self-test; cease operation for maintenance upon persistent waveｆorm abnormality;
This device is only for diagnostic signal acquisition and has no therapeutic function.
九、存储条件 Storage Conditions
中文放大器、计算机闲置存放温度：10℃～30℃；相对湿度：30%～75%，环境无凝露；环境：干燥通风、防尘；避免阳光直射、剧烈撞击、重压；远离强磁场、腐蚀性气体与液体；电极、导电耗材常温避光存放；长期停机存放前断开电源，线缆理顺收纳；建议每 3 个月通电试运行一次。
EnglishStorage Temperature (standby amplifier & computer): 10℃～30℃;Relative Humidity: 30%～75%, non-condensing;Environment: Dry, ventilated and dust-free; avoid direct sunlight, heavy impact and compression; keep away from strong magnetic field, corrosive gas and liquid;Store electrodes and conductive consumables at room temperature protected from light;Disconnect power before long-term storage and organize all cables; power on for trial operation every 3 months.
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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