厂家直供安迪特动态脑电图机AE-D20
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厂家直供安迪特动态脑电图机AE-D20
桂经理19117326863微xin同号
桂经理19117326863微xin同号
产品名称 动态脑电图机
管理类别 第二类
型号规格 AE-D20
结构及组成/主要组成成分 产品由动态盒、记录用电极线及软件组成。
适用范围/预期用途 用于动态显示和记录脑电图，不包含自动分析诊断功能。
中文名称：动态脑电图机English Name: Ambulatory Electroencephalograph型号：AE-D20注册证号：粤械注准 20222070983管理类别：Ⅱ 类有源医疗器械系统组成：便携式动态记录盒、脑电导联电极线、上位机分析软件；整机不含自动诊断算法，仅用于信号采集、存储、回放分析
一、工作原理 Working Principle
中文大脑神经元自发活动产生微伏级微弱生物电信号，通过头皮电极拾取送入便携式动态盒内置前置放大电路。设备采用高输入阻抗差分放大电路抑制共模干扰，对脑电模拟信号完成模数数字化采样；持续不间断长时间采集、本地固态存储原始脑电波形。受试者可在居家日常活动状态下完成连续监测；记录盒配备手动事件标记按键，患者 / 陪护可实时标记抽搐、头晕、意识异常等发作事件。监测结束后，通过数据接口将原始脑电数据导入电脑软件，实现波形回放、测量、频谱分析，供医师判读，捕捉短时、夜间、睡眠期不易在常规短时脑电图检出的异常放电波形。
EnglishSpontaneous neuronal activity in human brain generates microvolt-level weak bioelectrical signals, captured by scalp electrodes and transmitted to the built-in pre-amplifier circuit inside portable ambulatory recorder. The device adopts high-input-impedance differential amplification circuit to suppress common-mode interference, and completes analog-to-digital sampling of EEG signals. Raw EEG waveｆorms are continuously acquired and stored locally on solid-state memory for long-duration monitoring.Subjects can complete continuous monitoring during daily home activities. The recorder is equipped with manual event marker button, allowing patients or caregivers to record clinical events such as convulsions, dizziness and altered consciousness in real time. After monitoring, raw EEG data is imported into computer software via data interface for waveｆorm playback, measurement and spectral analysis for physician interpretation, to detect paroxysmal or sleep-related abnormal discharges hardly captured by routine short-term EEG.
二、产品功能 Functions
中文
20 通道连续采集人体头皮脑电信号，兼容国际 10-20 电极安放系统；
便携式长时间不间断离线记录，支持 24h/48h 长程动态脑电监测；
记录盒本地液晶实时预览波形，支持电极阻抗快速自检；
实体事件标记按键，随时记录各类临床发作事件；
上位机软件：波形回放、标尺测量、滤波调节、频谱分析、报告生成；
原始数据无损存储，支持自由滚动回放、通道独立开关显示；
可同步记录简易心电信号辅助鉴别伪迹；
USB 数据导出，支持数据归档管理。
English
Continuous acquisition of scalp EEG signals via 20 channels, compatible with international 10-20 electrode placement system;
Portable uninterrupted offline long-term recording, supporting 24h / 48h ambulatory EEG monitoring;
Built-in LCD screen for real-time waveｆorm preview on recorder; rapid electrode impedance self-test;
Physical event marker button to log clinical episodes at any time;
PC software functions: waveｆorm playback, cursor measurement, adjustable filtering, spectral analysis and report generation;
Lossless storage of raw data, supporting scroll playback and independent channel display toggle;
Synchronous simple ECG recording to assist artifact identification;
USB data export, supporting permanent data archiving.
三、产品特点 Product Features
中文
小型轻量化随身记录盒，内置锂电池，患者居家活动佩戴，行动限制少；
20 通道配置，满足成人、儿童癫痫长程筛查需求；
高共模抑制放大电路，有效降低居家环境工频、移动伪迹干扰；
机端阻抗检测，提前发现电极松动、导电膏干涸，减少无效记录；
独立事件标记按键，锚定发作时间，便于波形溯源；
原始数据完整保存，软件仅做离线滤波，不篡改原始采样波形；
低功耗设计，单次满电可持续完成标准 24 小时监测；
配套分析软件操作简洁，兼容盘状电极、网状电极帽。
English
Compact lightweight wearable recorder with built-in lithium battery, enabling home monitoring with minimal movement restriction;
20-channel configuration meeting long-term epilepsy screening requirements for adults and children;
High CMRR amplifier effectively suppresses power-line interference and motion artifacts in domestic environment;
On-device impedance test detects loose electrodes or dried conductive paste in advance to reduce invalid recordings;
Dedicated event marker button to accurately tag seizure time points for waveｆorm tracing;
Complete raw data preservation; software only applies offline filtering without altering original sampled waveｆorm;
Low-power design; fully charged battery supports standard 24-hour continuous recording;
User-friendly analysis software, compatible with disc electrodes and mesh EEG caps.
四、技术参数 Technical Specifications
| 中文 | English |
|---|---|
| 产品型号：AE-D20 | Model：AE-D20 |
| 通道配置：20 通道（19 导脑电 + 1 导参考 / 心电） | Channel Configuration：20 Channels (19 EEG + 1 Reference / ECG) |
| 采样频率：250Hz / 500Hz 可选 | Sampling Rate：Optional 250Hz / 500Hz |
| 输入阻抗：≥1GΩ | Input Impedance：≥1GΩ |
| 共模抑制比：＞100dB | CMRR：＞100dB |
| 带宽：0.1Hz～70Hz | Bandwidth：0.1Hz～70Hz |
| 模数转换精度：16bit A/D | A/D Resolution：16 bit |
| 供电：内置可充电锂电池 | Battery：Built-in rechargeable lithium battery |
| 连续记录时长：满电≥24h | Continuous Recording：≥24h on full charge |
| 数据传输：USB 有线导出 | Data Transfer：USB wired export |
| 运行环境温度：10℃～30℃ | Operating Ambient Temp：10℃～30℃ |
| 整机预期使用寿命：5 年 | Expected Service Life：5 years |
| 产品定位：离线动态脑电，不含视频同步模块 | Note: Offline ambulatory EEG, without synchronized video module |
五、使用方法 Operation Instructions
中文
提前将动态盒充满电；设备连接电脑，建立患者档案，设置采集参数；
按照国际 10-20 系统规范清洁患者头皮，粘贴电极、涂抹导电膏，连接导联线；
佩戴记录盒，启动阻抗检测，调整电极至阻抗达标；
正式启动记录；告知患者日常活动规范、禁止沾水、剧烈拉扯导线；指导陪护使用事件标记按键；
完成预设时长监测后，停止记录，关机回收设备；拆除电极，清洁头皮；
将记录盒连接电脑，导出全部原始脑电数据；
使用分析软件回放波形、测量、标注异常波，完成阅图并出具辅助报告；
清洁导联线，充电收纳动态盒。
English
Fully charge recorder in advance; connect device to PC, create patient profile and set acquisition parameters;
Clean patient scalp following 10-20 standard, attach electrodes with conductive paste and connect electrode cables;
Wear recorder on patient, run impedance test and adjust electrodes until qualified;
Start ｆormal recording; instruct patient about activity restrictions, avoid water contact and violent cable pulling; train caregiver to use event marker button;
Stop recording after scheduled monitoring duration, power off and retrieve equipment; remove electrodes and clean scalp;
Connect recorder to PC and export all raw EEG data;
Review waveｆorms via analysis software, perｆorm measurement, annotate abnormal waves and generate auxiliary report;
Clean electrode cables, charge and store recorder.
六、适应症 Indications
中文本设备用于人体脑电生理信号动态采集、存储、回放分析，辅助临床诊断：
不明原因抽搐、晕厥、发作性意识障碍，鉴别癫痫与非痫性发作；
常规短时脑电图阴性，但临床高度怀疑癫痫患者，捕捉睡眠期、夜间异常放电；
癫痫分型、抗癫痫药物疗效随访、减停药评估；
头痛、短暂、阵发性躯体异常症状病因筛查；
轻度脑外伤、代谢性脑病脑功能随访评估。⚠️ 仅提供脑电波形，不可单独作为确诊依据，必须由医师结合病史综合判读。
EnglishThis device dynamically acquires, stores, replays and analyzes human EEG signals to assist clinical diagnosis:
Differential diagnosis between epilepsy and non-epileptic spells for unexplained convulsion, syncope and paroxysmal unconsciousness;
Patients with negative routine short-term EEG but high clinical suspicion of epilepsy, to capture nocturnal and sleep-related epileptiｆorm discharges;
Epilepsy classification, follow-up of antiepileptic drug efficacy and medication tapering assessment;
Etiological screening for headache, transient amnesia and paroxysmal somatic symptoms;
Brain function follow-up for mild traumatic brain injury and ｍmbedbolic encephalopathy.⚠️ Only provides EEG waveｆorms and cannot be used as independent diagnostic evidence; comprehensive clinical judgment by qualified physicians is required.
七、禁忌症 Contraindications
中文动态脑电图检查，设备无绝对禁忌症；以下为检查相对禁忌：
头皮大面积破损、活动性感染、严重皮肤病，无法安放电极；
患者重度躁动、精神行为异常，无法配合佩戴设备长时间监测；
对导电膏、电极材料存在明确严重接触性皮炎；
危重症生命体征极不稳定，不适合居家移动监测。
EnglishAmbulatory EEG examination is non-invasive; the equipment has no absolute contraindications. The following are relative contraindications for testing:
Extensive scalp laceration, active infection or severe skin disease preventing electrode placement;
Severely agitated patients unable to wear equipment for long-term monitoring;
Confirmed severe contact dermatitis to conductive paste or electrode materials;
Critically ill patients with unstable vital signs unsuitable for home ambulatory monitoring.
八、注意事项 Precautions
中文
操作人员接受脑电图规范化培训，熟悉电极安放标准与伪迹识别；
监测前充分清洁头皮油脂，阻抗过高极易产生大量运动伪迹，影响判读；
告知受试者监测期间：禁止洗头洗澡、远离大功率家电、不要暴力拉扯导联线；
事件标记出现症状立即按下，同步记录发作文字日志便于对照波形；
动态盒严禁沾水、摔落；禁止自行拆机；
妥善保管患者原始脑电数据，遵守医疗隐私保护法规；
导联线定期清洁消毒，单人规范更换导电耗材；
定期设备校准、电池维护；出现波形失真、硬件故障立即停用报修；
本设备仅为诊断采集设备，不具备任何治疗功能。
English
Operators must receive standardized EEG training and master electrode placement standards and artifact recognition;
Thoroughly clean scalp sebum before monitoring; excessive impedance leads to massive motion artifacts affecting interpretation;
Instruct subjects: avoid shampoo/bathing, stay away from high-power electrical appliances and prevent violent cable pulling during monitoring;
Press event marker immediately when symptoms occur; keep written symptom log for waveｆorm cross-reference;
Prevent recorder from water contact and dropping; unauthorized disassembly is forbidden;
Securely archive patient raw EEG data and comply with medical privacy regulations;
Regular cleaning and disinfection of cables; replace conductive consumables for each patient;
Perｆorm periodic equipment calibration and battery maintenance; cease operation and arrange maintenance upon waveｆorm distortion or hardware failure;
This device is only for diagnostic signal acquisition and has no therapeutic function.
九、存储条件 Storage Conditions
中文动态记录盒闲置存放温度：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、撞击、重压；远离强磁场、腐蚀性气体与液体；电极、导电耗材常温避光保存；长期存放前充满电池并每隔 3 个月补电一次；线缆理顺收纳，避免长期弯折老化。
EnglishStorage Temperature for standby recorder：10℃～30℃;Relative Humidity：30%～75%, non-condensing;Environment：Dry, ventilated and dust-free; avoid direct sunlight, impact and compression; keep away from strong magnetic field, corrosive gas and liquid;Store electrodes and conductive consumables at room temperature away from light;Fully charge battery before long-term storage and recharge every 3 months; organize cables to avoid permanent bending and aging.
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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