厂商直供爱生听觉诱发电位仪SmartEP M010000
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厂商直供爱生听觉诱发电位仪SmartEP M010000
桂经理19117326863微xin同号
管理类别
第二类
型号规格
SmartEP M010000
结构及组成/主要组成成分
该产品由主机、插入式耳机、4孔导联线、5孔导联线、USB 线缆、电源线和客户端软件组成。
适用范围/预期用途
该产品可记录各年龄层的患者对听觉刺激的诱发反应，具有获取和测量听觉数据的功能。该产品应由受过培训的专业人员在医疗机构专用检测场所使用。
一、工作原理（Working Principle）
中文SmartEP M010000 通过声刺激诱发 + 生物电采集 + 信号叠加技术，客观记录听觉通路电反应：
声刺激生成：主机产生 Click（短声）、Tone Burst（短纯音）、iChirp（调频声）、言语声等刺激信号，经 ER-3C 耳机输出。
电信号采集：头皮电极（前额、乳突、耳垂）捕捉耳蜗→听神经→脑干→皮层的微弱生物电（微伏级）。
放大滤波：前置放大器（增益 5K–200K）+ 高低通滤波，滤除肌电、工频等干扰。
信号叠加：多次重复刺激（数百～数千次），通过平均叠加技术提取淹没在噪声中的诱发电位。
分析显示：软件自动识别波形（如 ABR 的 Ⅰ、Ⅲ、Ⅴ 波），测量潜伏期、波间期、振幅、阈值，生成波形图与诊断报告。
EnglishSmartEP M010000 ｏbjectively records electrical responses of the auditory pathway viaacoustic stimulation + bioelectric acquisition + signal averaging:
Stimulus Generation: Host produces Click, Tone Burst, iChirp, speech sounds, delivered via ER-3C earphones.
Signal Acquisition: Scalp electrodes (forehead, mastoid, earlobe) capture weak bioelectricity (µV-level) from cochlea → auditory nerve → brainstem → cortex.
Amplification & Filtering: Preamplifier (gain 5K–200K) + high/low-pass filters remove EMG, line noise.
Signal Averaging: Hundreds–thousands of repetitions extract evoked potentials from noise viaensemble averaging.
Analysis & Display: Software auto-identifies waveｆorms (e.g., ABR waves Ⅰ, Ⅲ, Ⅴ), measures latency, interpeak latency, amplitude, threshold; generates graphs & reports.
二、产品功能（Functions）
中文
1. 核心诱发电位测试
ABR（听性脑干反应）：Click/Tone Burst/iChirp-ABR、阈值 ABR、eABR（人工耳蜗术后）、AABR（自动筛查）
ASSR（多频稳态反应）：多频率（0.5~8kHz）同步客观测听，适合重度聋 / 婴幼儿
ECochG（耳蜗电图）：CM（耳蜗微音电位）、SP/AP，诊断梅尼埃病、膜迷路积水
中 / 长潜伏期：MLR（40Hz-AEP）、LLR、P50、P300、MMN（认知 / 中枢评估）
前庭电位：cVEMP/oVEMP（球囊 / 椭圆囊功能）
其他：术中听神经监护、声场 ABR、复合言语声 ABR、动物实验高频 ABR
2. 软件功能
自动分析、峰值标记、阈值计算、 normative 数据对比
病例数据库、多格式报告（PDF）、数据导出
阻抗实时监测、信噪比（SNR）显示
自定义刺激、测试协议、波形对比
English
1. Core Evoked Potential Tests
ABR (Auditory Brainstem Response): Click/Tone Burst/iChirp-ABR, threshold ABR, eABR (post-cochlear implant), AABR (automated screening)
ASSR (Auditory Steady-State Response): Multi-frequency (0.5–8kHz) ｏbjective audiometry, ideal for severe hearing loss/infants
ECochG (Electrocochleography): CM, SP/AP for Meniere’s disease, endolymphatic hydrops
Mid/Late Latency: MLR (40Hz-AEP), LLR, P50, P300, MMN (cognitive/central assessment)
Vestibular Potentials: cVEMP/oVEMP (saccular/utricular function)
Others: Intraoperative nerve monitoring, field ABR, speech ABR, high-frequency animal ABR
2. Software Features
Auto-analysis, peak labeling, threshold calculation, normative comparison
Patient DB, multi-ｆormat reports (PDF), data export
Real-time impedance, SNR display
Custom stimuli, protocols, waveｆorm comparis
三、产品特点（Features）
中文
双通道高清采集：2 通道独立放大，高分辨率、低残余噪声、高 SNR
宽频刺激：Click / 短纯音 /iChirp/ 复合声 / 言语声，覆盖 250Hz~32kHz
便携式一体化：Duet 主机（<2kg），USB 连接电脑，适合门诊 / 急诊 / NICU / 手术室
抗干扰强：全屏蔽隔离，手术室可靠监护，抗电磁干扰
智能高效：AABR 自动判读、ASSR 多频同步、测试时间缩短 50%
临床：覆盖诊断 + 筛查 + 术中监护 + 科研，NOAH 兼容
稳定：1dB 步进、校准标准、长期漂移小、重复性好
操作便捷：中文界面、预设协议、一键启动、远程控制
English
Dual-Channel High-Definition: 2 independent channels, high resolution, low residual noise, high SNR
Wideband Stimuli: Click/tone burst/iChirp/complex/speech, 250Hz–32kHz
Portable All-in-One: Duet (<2kg), USB-connected, for clinic/ER/NICU/OR
Superior Noise Immunity: Full shielding, reliable OR monitoring, EMI-resistant
Smart & Efficient: AABR auto-interpretation, ASSR multi-frequency sync, 50% faster testing
Comprehensive Clinical: Diagnostic/screening/intraoperative/research, NOAH-compatible
Accurate & Stable: 1dB steps, calibrated standards, low drift, high repeatability
User-Friendly: Chinese UI, preset protocols, one-key start, remote control
四、技术参数（Specifications）
中文
型号：SmartEP M010000（平台：Duet M010300）
通道：2 通道生物电放大
增益：5,000~200,000 倍可调
滤波：高通 0.1~300Hz，低通 100~10,000Hz（-6dB/Oct）
采样率：≥20kHz / 通道
刺激类型：Click（100µs）、Tone Burst（250~8,000Hz）、iChirp、复合声、言语声
强度范围：0~120dB HL（ER-3C），1dB 步进
电极：Ag/AgCl 表面电极，阻抗监测 0~10kΩ
电源：AC 115~230V 50/60Hz，30W
主机：28×25×6cm，约 1.8kg
电脑：Windows 7/8/10，4GB RAM，USB 2.0
注册证：国械注进 20182070471
标准：IEC 60601-1、IEC 60645-3、ANSI/ASA S3.39
English
Model: SmartEP M010000 (Platｆorm: Duet M010300)
Channels: 2-channel bio-amplifier
Gain: 5,000–200,000 adjustable
Filters: HP 0.1–300Hz, LP 100–10,000Hz (-6dB/Oct)
Sampling Rate: ≥20kHz/channel
Stimuli: Click (100µs), Tone Burst (250–8,000Hz), iChirp, complex, speech
Level Range: 0–120dB HL (ER-3C), 1dB steps
Electrodes: Ag/AgCl surface, impedance monitoring 0–10kΩ
Power: AC 115–230V 50/60Hz, 30W
Main Unit: 28×25×6cm, ~1.8kg
PC: Windows 7/8/10, 4GB RAM, USB 2.0
Cert: China Import Reg 20182070471
Standards: IEC 60601-1, IEC 60645-3, ANSI/ASA S3.39
五、使用方法（Instructions）
中文
准备
设备：开机、自检、USB 连接电脑、启动 SmartEP 软件
患者：清洁头皮（酒精 / 磨砂膏）、去角质、脱脂；停镇静剂 / 抗抑郁药 24~48 小时；婴幼儿镇静（必要时）
环境：电磁屏蔽、安静、光线柔和
电极放置
正极（+）：同侧乳突（+Cz）
负极（-）：对侧乳突 / 耳垂
接地（GND）：前额正中（Fz）
阻抗：<5kΩ，双耳对称
测试流程
选测试协议（ABR/ASSR/ECochG 等）
戴 ER-3C 耳机，校准声强
启动采集，观察波形与 SNR
自动 / 手动标记峰值，计算阈值、潜伏期
结束
保存病例、导出报告、打印
取下电极、清洁皮肤、设备消毒
关机、整理、充电
English
Preparation
Device: Power on, self-test, USB connect to PC, launch SmartEP
Patient: Clean scalp (alcohol/abrasive), exfoliate/degrease; stop sedatives/antidepressants 24–48hr; sedate infants if needed
Environment: EMI-shielded, quiet, dim light
Electrode Placement
Active (+): Ipsilateral mastoid (+Cz)
Reference (-): Contralateral mastoid/earlobe
Ground (GND): Mid-forehead (Fz)
Impedance: <5kΩ, symmetric between ears
Testing Sequence
Select protocol (ABR/ASSR/ECochG)
Fit ER-3C, calibrate levels
Start acquisition, monitor waveｆorm & SNR
Auto/manual peak labeling, calculate threshold/latency
Completion
Save case, export/print report
Remove electrodes, clean skin, disinfect equipment
Power down, organize, charge
六、适应症（Indications）
中文
客观听阈评估：新生儿 / 婴幼儿 / 无法配合者的听力筛查与诊断
听力损失定性：传导性 / 感音神经性 / 混合性聋鉴别
蜗后病变诊断：听神经瘤、脑干病变、多发性硬化
内耳疾病：梅尼埃病、膜迷路积水（ECochG）
人工耳蜗：术前评估、术后调试、eABR 监测
前庭功能：cVEMP/oVEMP 评估球囊 / 椭圆囊、前庭神经炎
中枢听觉：中枢处理障碍、认知功能（P300/MMN）
术中监护：听神经瘤手术、脑干手术神经监护
伪聋鉴别：客观证实听力损失真实性
English
Objective Threshold: Hearing screening/diagnosis for neonates/infants/uncooperative
Hearing Loss Typing: Differentiate conductive/sensorineural/mixed
Retrocochlear Diagnosis: Acoustic neuroma, brainstem lesions, multiple sclerosis
Inner Ear Disorders: Meniere’s disease, endolymphatic hydrops (ECochG)
Cochlear Implant: Pre-op assessment, post-op fitting, eABR monitoring
Vestibular Function: cVEMP/oVEMP for saccule/utricle, vestibular neuritis
Central Auditory: Central processing disorders, cognition (P300/MMN)
Intraoperative Monitoring: Nerve monitoring in acoustic neuroma/brainstem surgery
Malingering Detection: Objectively verify hearing loss authenticity
七、禁忌症（Contraindications）
中文
绝对禁忌
头皮破损、感染、溃疡（电极放置区）
癫痫发作未控制、严重颅内高压
对电极膏 / 导电膏严重过敏者
相对禁忌（慎用 / 暂缓）
急性中耳炎、外耳道炎症（先治疗）
严重凝血障碍、出血倾向（电极损伤风险）
精神异常、无法制动（干扰波形）
严重心肺疾病、生命体征不稳定
头部外伤急性期、颅内出血
English
Absolute Contraindications
Scalp breakdown, infection, ulcers (electrode sites)
Uncontrolled seizures, severe intracranial hypertension
Severe allergy to electrode/conductive paste
Relative (Caution/Suspend)
Acute otitis media, otitis externa (treat first)
Severe coagulopathy, bleeding tendency (electrode injury risk)
Psychiatric disorders, inability to immobilize (waveｆorm interference)
Severe cardiopulmonary disease, unstable vital signs
Acute head trauma, intracranial hemorrhage
八、注意事项（Precautions）
中文
患者准备
严格遵医嘱停药，避免镇静 / 酒精 / 疲劳影响波形
头皮清洁，保证低阻抗（<5kΩ）
婴幼儿测试需镇静，全程监护生命体征
操作规范
电极放置准确，阻抗对称，防止移动伪迹
环境屏蔽干扰，远离手机、电器、高频设备
声强不超 120dB HL，避免听觉损伤
术中监护严格无菌，防感染
设备维护
每日清洁电极、耳机、线缆；定期校准（每年）
软件定期更新，数据每日备份
防摔、防潮、防尘、防高温、防强磁
结果判读
结合病史、耳镜、纯音测听综合判断
注意年龄、性别、镇静状态对潜伏期影响
波形分化差时重复测试，排除技术因素
English
Patient Preparation
Strict medication compliance; avoid sedation/alcohol/fatigue
Thorough scalp cleaning for low impedance (<5kΩ)
Sedate infants; monitor vital signs throughout
Operation
Accurate electrode placement, symmetric impedance, prevent movement artifact
Shield environment; keep away from phones, electronics, RF devices
Level ≤120dB HL to avoid hearing trauma
Sterile technique for intraoperative monitoring
Device Maintenance
Daily cleaning of electrodes/earphones/cables; annual calibration
Regular software updates, daily data backup
Protect from shock, moisture, dust, heat, strong magnets
Interpretation
Correlate with history, otoscopy, pure tone audiometry
Account for age, gender, sedation on latency
Repeat poor waveｆorm; rule out technical factors
九、存储条件（Storage）
中文
温度：0°C ～ +50°C（运输：-20°C ～ +50°C）
湿度：15% ～ 90% RH（无冷凝）
气压：700 ～ 1060 hPa
环境：干燥、通风、清洁、无腐蚀性气体、无强电磁干扰
防护：防尘、防潮、防震、防阳光直射、防液体溅洒
长期存储：原包装、防潮箱；电池（若有）取出单独存放
English
Temperature: 0°C to +50°C (Shipping: -20°C to +50°C)
Humidity: 15%–90% RH (non-condensing)
Pressure: 700–1060 hPa
Environment: Dry, ventilated, clean, no corrosive gases, strong EMI
Protection: Dust, moisture, shock, direct sunlight, liquid splash
Long-Term: Original packaging, dry cabinet; remove batteries (if any)
十、说明书核心信息（Manual Summary）
中文
名称：听觉诱发电位仪 SmartEP M010000
分类：二类医疗器械（6807 医用电子仪器设备）
生产：美国 Intelligent Hearing Systems（智听）
注册证：国械注进 20182070471
组成：Duet 主机、ER-3C 耳机、电极线、USB 线、软件
适用：全年龄客观听力评估、前庭 / 中枢诊断、术中监护
科室：耳鼻喉科、儿科、神经内科、ICU、手术室、康复科
用户：听力师、神经科医生、技师、外科医生
保修：1 年（厂家标准）
处置：按电子废弃物法规处理
English
Name: Auditory Evoked Potential System SmartEP M010000
Class: Class II Medical Device (6807 Electronic Medical Equipment)
Manufacturer: Intelligent Hearing Systems (IHS), USA
Cert: China Import Reg 20182070471
Components: Duet main unit, ER-3C earphones, electrode cables, USB cable, software
Purpose: All-age ｏbjective audiometry, vestibular/central diagnosis, intraoperative monitoring
Departments: ENT, Pediatrics, Neurology, ICU, OR, Rehabilitation
Users: Audiologists, Neurologists, Technicians, Surgeons
Warranty: 1-year (manufacturer standard)
Disposal: Dispose per e-waste regulations
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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