厂商直销国际听力听觉测试系统Eclipse
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详细内容
厂商直销国际听力听觉测试系统Eclipse
桂经理19117326863微xin同号
管理类别
第二类
型号规格
Eclipse
结构及组成/主要组成成分
产品由Eclipse主机、电源线、ÙSB连接线以及七个和产品相关的可
选模块组成。
一、工作原理（Working Principle）
中文
听觉诱发电位（ABR/EP）原理通过 CE-Chirp®/Click/Tone Burst 刺激声激发耳蜗→听神经→脑干电位，经前置放大器采集、滤波、叠加平均，提取 Ⅰ/Ⅲ/Ⅴ 波，测定潜伏期、波间期、阈值，判断耳蜗、听神经、脑干通路功能与听力损失程度。CE-Chirp® 专利刺激补偿耳蜗行波延迟，波形幅度较传统 Click 高约 2 倍。
听觉稳态反应（ASSR）原理采用 调幅 / 调频（AM/FM） 多频稳态刺激（500/1000/2000/4000Hz），同步记录多频率稳态电位，频率特异性评估听阈，适用于婴幼儿、不配合者客观测听。
耳声发射（OAE）原理
TEOAE：短声刺激，记录耳蜗外毛细胞主动释能产生的瞬态声信号，评估耳蜗外毛细胞功能。
DPOAE：双频纯音（f1/f2）刺激，记录畸变产物信号，频率特异性筛查耳蜗功能。
前庭诱发肌源性电位（VEMP）原理
声刺激诱发胸锁乳突肌（cVEMP）/ 眼外肌（oVEMP） 电位，评估前庭球囊、椭圆囊、前庭下 / 上神经功能。
English
Auditory Evoked Potential (ABR/EP) PrincipleStimuli (CE-Chirp®/Click/Tone Burst) activate cochlea→auditory nerve→brainstem; preamp amplifies, filters, averages signals to extract waves Ⅰ/Ⅲ/Ⅴ; measures latency, interpeak latency, threshold to assess cochlear, nerve, brainstem function. CE-Chirp® compensates traveling-wave delay, yielding ~2× larger amplitudes than conventional clicks.
Auditory Steady-State Response (ASSR) PrincipleAM/FM-modulated multi-frequency stimuli (500/1000/2000/4000Hz); records steady-state potentials for frequency-specific threshold estimation; ideal for infants/uncooperative patients.
Otoacoustic Emission (OAE) Principle
TEOAE: Click-evoked transient emissions from outer hair cells (OHC); assesses OHC function.
DPOAE: Dual-tone (f1/f2) evokes distortion products; frequency-specific cochlear screening.
Vestibular Evoked Myogenic Potential (VEMP) Principle
Acoustic stimuli evoke sternocleidomastoid (cVEMP)/extraocular (oVEMP) potentials; evaluates saccular, utricular, inferior/superior vestibular nerve function.
二、产品功能（Product Functions）
中文
1. ABR 模块（EP15/EP25/ABRIS）
刺激声：CE-Chirp®、Click、Tone Burst（500–4000Hz）、NB CE-Chirp
测试：ABR、EcochG（耳蜗电图）、MLR、LLR、P300、MMN
智能：自动波标记、信噪比（SNR）判断、自动停止、Fmp 可信度指标
筛查：ABRIS（婴幼儿快速 ABR 筛查）
2. ASSR 模块
频率：500/1000/2000/4000Hz（8 通道双频同步）
模式：4Hz/90Hz 调制、自动阈值、频率特异性评估
3. OAE 模块
TEOAE25：瞬态诱发、线性 / 非线性、30–90dB peSPL
DPOAE20：畸变产物、f2/f1=1.22、I/O 函数、频率特异性
4. VEMP 模块
cVEMP（球囊）、oVEMP（椭圆囊）、阈值 / 振幅 / 不对称比
刺激：Click / 纯音、500–2000Hz、20–135dB peSPL
5. 数据与报告
兼容 NOAH/OtoAccess、PDF/XML 导出、EMR 对接
多曲线对比、自动报告、数据库存储（无限）
English
1. ABR Module (EP15/EP25/ABRIS)
Stimuli: CE-Chirp®, Click, Tone Burst (500–4000Hz), NB CE-Chirp
Tests: ABR, EcochG, MLR, LLR, P300, MMN
Smart: Auto wave labeling, SNR auto-stop, Fmp confidence index
Screening: ABRIS (infant rapid ABR)
2. ASSR Module
Frequencies: 500/1000/2000/4000Hz (8-channel dual-frequency)
Modes: 4Hz/90Hz modulation, auto-threshold, frequency-specific
3. OAE Module
TEOAE25: Transient-evoked, linear/non-linear, 30–90dB peSPL
DPOAE20: Distortion product, f2/f1=1.22, I/O functions
4. VEMP Module
cVEMP (saccule), oVEMP (utricle), threshold/amplitude/asymmetry
Stimuli: Click/tone, 500–2000Hz, 20–135dB peSPL
5. Data & Reporting
NOAH/OtoAccess compatible, PDF/XML export, EMR integration
Overlaid waveｆorms, auto-reports, unlimited database
三、产品特点（Product Features）
中文
CE-Chirp® 专利刺激：幅度提升 2 倍、波形更清晰、阈值更准、测试更快
8 通道全集成：ABR+ASSR+OAE+VEMP 一机完成，模块化升级
超低噪声前置：电噪声极低、贝氏计权抗干扰、普通门诊稳定测试
智能辅助：自动波标记、Fmp 可信度、自动停止、儿童 / 睡眠适配
全年龄段：新生儿（ABRIS）、婴幼儿、成人、老人、不配合者
便携紧凑：2.5kg、28×32×5.5cm、USB 供电、PC 控制
合规：IEC 60645-3/6、ANSI、CE 0123、Type BF 医用安全
拓展性强：软件模块授权升级、支持插入式 / 头戴 / 骨导 / 声场
English
CE-Chirp® Patent: 2× amplitude, clearer waveｆorms, faster, more accurate thresholds
8-Channel All-In-One: ABR+ASSR+OAE+VEMP; modular upgrade
Ultra-Low Noise Preamplifier: Superior EMI rejection, stable in non-soundproof rooms
Smart Tools: Auto wave labeling, Fmp confidence, auto-stop, pediatric/sleep-friendly
All Ages: Newborn (ABRIS), infant, adult, elderly, uncooperative
Compact & Portable: 2.5kg, 28×32×5.5cm, USB-powered, PC-controlled
Regulatory Compliant: IEC 60645-3/6, ANSI, CE 0123, Type BF safety
Highly Expandable: Software-upgradable; insert/headphone/bone/field options
四、技术参数（Technical Specifications）
中文
放大器：2 通道标准（可选 4 通道）、输入阻抗 ≥10MΩ、采样 30kHz、16bit
刺激参数
ABR：Click/Tone Burst/CE-Chirp，0.1–80.1 次 / 秒，20–135.5dB peSPL
ASSR：500–4000Hz，8 通道，4Hz/90Hz 调制
OAE：TEOAE 500–5500Hz；DPOAE f2/f1=1.22，30–80dB SPL
VEMP：Click / 纯音，500–2000Hz，20–135dB peSPL
滤波：ABR 100–3000Hz；ASSR 4–300Hz；OAE 0.5–5.5kHz
电极：电阻监测 0.5–25kΩ、≤3kΩ 合格、33Hz 测量电流 19µA
换能器：插入式 3A 耳机、TDH39、B81 骨导、声场扬声器（可选）
尺寸 / 重量：280×320×55mm、2.5kg
电源：USB 5V、PC 供电、无内置电池
环境：工作 0–50℃、湿度 10–95%（无冷凝）
标准：IEC 60645-3/6、IEC 60601-1、CE 0123
English
Amplifier: 2-ch standard (4-ch opt), ≥10MΩ input Z, 30kHz sampling, 16bit
Stimulus
ABR: Click/Tone Burst/CE-Chirp, 0.1–80.1/s, 20–135.5dB peSPL
ASSR: 500–4000Hz, 8-ch, 4Hz/90Hz modulation
OAE: TEOAE 500–5500Hz; DPOAE f2/f1=1.22, 30–80dB SPL
VEMP: Click/tone, 500–2000Hz, 20–135dB peSPL
Filtering: ABR 100–3000Hz; ASSR 4–300Hz; OAE 0.5–5.5kHz
Electrodes: Z 0.5–25kΩ, pass ≤3kΩ, 33Hz 19µA current
Transducers: Insert 3A, TDH39, B81 bone, free-field (opt)
Dimensions/Weight: 280×320×55mm, 2.5kg
Power: USB 5V, PC-powered; no internal battery
Environment: Operating 0–50℃, 10–95%RH (non-condensing)
Standards: IEC 60645-3/6, IEC 60601-1, CE 0123
五、使用方法（Usage Method）
中文
准备
设备：USB 连 PC、启动软件、自检校准
患者：清洁皮肤（前额 / 乳突 / 眉间）、去角质、涂导电膏；电极安置（极间电阻 ≤3kΩ）
配件：插入式耳机、OAE 探头、电极线、接地
ABR/ASSR 测试
选协议 → 设参数（刺激 / 滤波 / 叠加）→ 自动采集 → 波形标记 → 阈值判定 → 保存
OAE 测试
探头密封外耳道 → TEOAE/DPOAE → 自动采集 → SNR 判断 → 合格 / 不合格 → 保存
VEMP 测试
cVEMP：胸锁乳突肌紧张；oVEMP：眼球注视 → 刺激 → 记录 → 分析
结束
生成报告 → 打印 / 导出 → 清洁电极 / 探头 → 关机
English
Preparation
Equipment: USB-connect to PC, launch software, self-test/calibrate
Patient: Clean skin (forehead/mastoid/glabella), abrade, apply gel; place electrodes (Z ≤3kΩ)
Accessories: Insert earphones, OAE probe, electrode leads, ground
ABR/ASSR Procedure
Select protocol → set parameters → auto-average → wave label → threshold → save
OAE Procedure
Probe seal → TEOAE/DPOAE → auto-record → SNR pass/fail → save
VEMP Procedure
cVEMP: SCM tension; oVEMP: eye fixation → stimulate → record → analyze
Completion
Generate report → print/export → clean electrodes/probe → shut down
六、适应症（Indications）
中文
新生儿 / 婴幼儿：听力筛查（ABRIS/TEOAE）、客观听阈评估、听力损失诊断
听力损失定位：传导性 / 感音神经性 / 混合性、耳蜗 / 听神经 / 脑干病变
耳科疾病：中耳炎、耳硬化、梅尼埃、大前庭导水管、听神经瘤
前庭评估：眩晕、前庭神经炎、耳石症、前庭功能不全（VEMP）
术中监测：听神经瘤手术、人工耳蜗植入（eABR）
特殊人群：昏迷、智力障碍、精神疾病、不配合者客观听力检查
随访监测：耳毒性药物、噪声暴露、听力康复、术后评估
English
Newborn/Infant: Hearing screening (ABRIS/TEOAE), ｏbjective threshold, loss diagnosis
Loss Localization: Conductive/sensorineural/mixed, cochlear/nerve/brainstem lesions
Otologic Disorders: Otitis media, otosclerosis, Meniere’s, EVA, vestibular schwannoma
Vestibular Assessment: Vertigo, neuritis, BPPV, vestibular hypofunction (VEMP)
Intraoperative Monitoring: Acoustic tumor, cochlear implant (eABR)
Special Populations: Coma, intellectual disability, psychosis, uncooperative
Monitoring: Ototoxicity, noise exposure, rehab, post-op follow-up
七、禁忌症（Contraindications）
中文
绝对禁忌
急性外耳道炎 / 湿疹、严重耳痛、活动性流脓
鼓膜穿孔急性期（<2 周）、外耳道闭锁 / 严重狭窄
颈部急性损伤 / 骨折（禁 cVEMP）
全盲 / 眼球摘除（禁 oVEMP）
皮肤感染 / 破损（电极安置区）
相对禁忌
癫痫发作期、严重精神障碍、不自主运动
严重心脑血管病急性期、生命体征不稳定
外耳道异物 / 耵聍栓塞（未清理）
极度烦躁 / 哭闹无法安静（需镇静 / 转诊）
English
Absolute Contraindications
Acute otitis externa/eczema, pain, active otorrhea
Acute TM perforation (<2w), canal atresia/stenosis
Acute neck injury/fracture (cVEMP)
Total blindness/enucleation (oVEMP)
Skin infection/breakdown (electrode sites)
Relative Contraindications
Active epilepsy, severe psychosis, involuntary movements
Acute CV instability, critical illness
Foreign body/cerumen impaction (uncleaned)
Uncontrollable agitation (sedate/refer)
八、注意事项（Precautions）
中文
操作：专业培训；年度校准；环境噪声 <40dB (A)；远离电磁干扰
电极：电阻 ≤3kΩ；皮肤清洁 / 去角质；避免移动 / 伪迹
刺激：强度 ≤115dB peSPL；儿童 / 婴儿降低强度；不适即停
患者：测试前 48h 禁酒 / 镇静剂；睡眠状态更佳；儿童需安抚
清洁：75% 酒精擦探头 / 电极；禁液体渗入机身
质控：排除眨眼、肌电、工频干扰；SNR ≥6dB（ABR）、≥3dB（OAE）
解读：结合声阻抗、纯音测听、耳镜综合诊断
English
Operation: Trained staff; annual calibration; ambient <40dB(A); avoid EMI
Electrodes: Z ≤3kΩ; clean/abrade skin; prevent movement/artifact
Stimulus: Max ≤115dB peSPL; reduce for infants; stop if distressed
Patient: No alcohol/sedatives 48h prior; sleep preferred; calm pediatric
Cleaning: 75% alcohol wipe probe/electrodes; no liquid ingress
QC: Reject blink/EMI/line noise; SNR ≥6dB (ABR), ≥3dB (OAE)
Interpretation: Correlate with tympanometry, audiometry, otoscopy
九、存储条件（Storage Conditions）
中文
温度：工作 0–50℃；存储 -20–+60℃
湿度：10–95%（无冷凝）
气压：86–106kPa
环境：干燥、通风、无尘；远离热源、腐蚀、强电磁
设备：主机入箱；配件分类；线缆整理；定期软件备份
English
Temperature: Operating 0–50℃; Storage -20–+60℃
Humidity: 10–95% (non-condensing)
Pressure: 86–106kPa
Environment: Dry, ventilated, dust-free; away from heat, corrosion, EMI
Equipment: Store in case; organize accessories; software backup
十、说明书核心信息（Manual Core）
中文
制造商：Interacoustics A/S（丹麦）；CE 0123；IEC 60601-1
型号：Eclipse（基础）、EP15/EP25/ABRIS/ASSR/OAE/VEMP（模块）
软件：v4.5+；NOAH 3.6–8、OtoAccess 兼容
维护：年度校准；季度清洁；电极 / 探头定期更换
故障：无信号 → 查 USB / 驱动；伪迹 → 查电极 / 接地；噪声 → 抗干扰
保修：整机 2 年；配件 1 年；人为损坏 / 非授权维修除外
安全：Type BF 医用；禁易燃环境；专业人员操作
English
Manufacturer: Interacoustics A/S (Denmark); CE 0123; IEC 60601-1
Models: Eclipse base; EP15/EP25/ABRIS/ASSR/OAE/VEMP modules
Software: v4.5+; NOAH 3.6–8, OtoAccess compatible
Maintenance: Annual calibration; quarterly cleaning; replace electrodes/probe
Troubleshooting: No signal → check USB/driver; artifact → check electrodes/ground; noise → EMI control
Warranty: 2-year system; 1-year accessories; exclude damage/unauthorized repair
Safety: Type BF; no flammable environments; professional use only
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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