厂家直供德国麦科客观听力测试仪Ero•Scan
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厂家直供德国麦科客观听力测试仪Ero•Scan
桂经理19117326863微xin同号
管理类别
第二类
型号规格
Ero•Scan
结构及组成/主要组成成分
产品由主机、探头、耳塞、电源适配器组成。
适用范围/预期用途
客观听力测试仪用于进行畸变产物耳声发射(DPOAE)和瞬态诱发性耳声发射（TEOAE） 测试。
一、工作原理（Working Principle）
中文
耳声发射（OAE）基础原理
耳蜗外毛细胞在受到外界声音刺激时，会产生机械振动并向外耳道发射 微弱音频信号（耳声发射），通过高灵敏度探头麦克风捕获该信号，可 客观评估耳蜗外毛细胞功能，判断是否存在耳蜗性听力损伤。
DPOAE（畸变产物耳声发射）：仪器发射 两个不同频率（f1、f2）的纯音刺激（f2/f1=1.22），耳蜗产生 畸变产物频率信号（2f1-f2），检测该信号的 幅值、信噪比（SNR），评估高频听力功能。
TEOAE（瞬态诱发耳声发射）：仪器发射 短声（Click）刺激，耳蜗产生 瞬态声能反射信号，检测信号的 潜伏期、幅值、带宽，评估中低频听力功能。
全自动测试与信号处理内置 24 位高速 DSP 处理器，采用 降噪算法与二项式统计法，自动过滤环境噪声、提取 OAE 信号，自动判断 PASS（通过）/REFER（转诊），无需人工分析。
抗干扰技术优化信号采集与滤波，环境噪声≤70dB SPL 时可稳定测试，无需隔音室，适配门诊、病房、移动筛查场景。
English
OAE Basic Principle
Outer hair cells (OHCs) in the cochlea generate weak acoustic signals (OAEs) when stimulated. A high-sensitivity probe microphone captures these signals to ｏbjectively assess OHC function and cochlear hearing loss.
DPOAE: Two pure tones (f1, f2; f2/f1=1.22) are presented; the cochlea produces a distortion product (2f1-f2). Signal amplitude & SNR are measured to evaluate high-frequency hearing.
TEOAE: A brief click stimulus evokes transient acoustic energy reflection. Signal latency, amplitude, bandwidth are measured to assess mid-low frequency hearing.
Automatic Testing & Signal Processing24-bit high-speed DSP, noise-reduction algorithm & binomial statistics auto-filter noise, extract OAEs, and determine PASS/REFER without manual analysis.
Anti-Interference TechnologyOptimized filtering enables reliable testing at ≤70dB SPL ambient noise—no sound booth required, ideal for clinics, wards, mobile screening.
二、产品功能（Product Functions）
中文
1. 核心测试模式
DPOAE 测试：1.5~12kHz（标准 2~5kHz），40~70dB SPL 刺激，自动阈值、SNR 分析。
TEOAE 测试：0.7~4kHz，83dB peSPL 短声刺激，瞬态信号检测。
DPOAE+TEOAE 二合一：联合筛查，覆盖全频段，提升准确率。
筛查 / 诊断双协议：5 种 DPOAE、3 种 TEOAE 协议，4 种可自定义。
2. 自动评估与结果
自动判读 PASS/REFER，显示波形、SNR、幅值、噪声水平。
内置 二项式统计法，降低假阳性 / 假阴性。
3. 数据管理
存储 ≥250 条测试记录，支持中文姓名 / ID 录入。
USB / 蓝牙传输至 PC，对接 NOAH/OtoAccess 数据库。
选配蓝牙打印机，3 秒快速打印报告。
4. 便捷功能
开机 自动校准，无需每日手动耦合腔校准。
自动关机（0.5~4 分钟）、低电量提醒、状态指示灯。
双探头：标准金属探头 + 新生儿微型软探头。
English
1. Core Test Modes
DPOAE: 1.5–12kHz (std 2–5kHz), 40–70dB SPL, auto-threshold & SNR analysis.
TEOAE: 0.7–4kHz, 83dB peSPL click, transient signal detection.
Combined DPOAE+TEOAE: Full-band screening, higher accuracy.
Screening/Diagnostic Protocols: 5 DPOAE, 3 TEOAE, 4 customizable.
2. Auto Evaluation
Auto PASS/REFER; display waveｆorm, SNR, amplitude, noise floor.
Binomial statistics reduce false pos/neg.
3. Data Management
Stores ≥250 tests; Chinese name/ID input.
USB/Bluetooth to PC; NOAH/OtoAccess compatible.
Optional Bluetooth printer: reports in <3s.
4. Convenience
Auto-calibration on power-up; no daily manual calibration.
Auto power-off (0.5–4min), low-battery alert, status LEDs.
Dual probes: standard ｍmbedl + neonatal soft probe.
三、产品特点（Product Features）
中文
超轻便携：主机仅 180~234g，单手操作，口袋级便携。
双技术全覆盖：DPOAE+TEOAE，筛查 + 诊断，全年龄段适配。
极速测试：单耳 <10 秒（最快 8 秒），批量筛查高效。
强抗干扰：≤70dB SPL环境稳定测试，无需隔音室。
全自动智能：开机自检、自动校准、自动判读、自动存储。
双探头设计：耐用金属探头 + 新生儿软探头，防耵聍堵塞。
长续航：3.6V 锂电池，连续工作 20 小时 / 1000 次测试。
全中文界面：彩色 LCD，图形化显示，操作极简。
德国品质：MAICO 原厂，IEC 60645-6、FDA、CE 认证。
English
Ultra-Portable: Only 180–234g, one-hand operation, pocket-sized.
Dual Technology: DPOAE+TEOAE, screen+diagnose, all ages.
Ultra-Fast: <10s/ear (as fast as 8s), high-throughput screening.
High Noise Tolerance: Reliable at ≤70dB SPL—no booth needed.
Fully Automatic: Self-test, auto-cal, auto-interpret, auto-save.
Dual Probes: Durable ｍmbedl + neonatal soft tip, cerumen-resistant.
Long Battery: 3.6V Li-ion, 20hr/1000 tests per charge.
Chinese UI: Color LCD, graphic display, simple operation.
German Quality: MAICO original, IEC 60645-6, FDA, CE certified.
四、技术参数（Technical Specifications）
中文
表格
项目 参数规格
测试技术 DPOAE、TEOAE、DPOAE+TEOAE
DPOAE 频率 1.5~12kHz（标准 2~5kHz）
TEOAE 频率 0.7~4kHz
刺激强度 DPOAE：40~70dB SPL；TEOAE：83dB peSPL
最大输出 90dB SPL（安全保护）
采样率 31.25kHz
麦克风噪声 2kHz 时≤-20dB SPL；1kHz 时≤-13dB SPL（1Hz BW）
测试时间 单耳＜10 秒
显示 彩色 LCD，10 字符 ×4 行
存储 ≥250 条测试
尺寸 / 重量 8.5×13×5cm；180~234g
电源 3.6V 锂电池，续航 20 小时
环境噪声 耐受≤70dB SPL
标准 IEC 60645-6、ANSI S3.36、CE 0124
English
表格
Item Specifications
Technologies DPOAE, TEOAE, Combined
DPOAE Freq 1.5–12kHz (std 2–5kHz)
TEOAE Freq 0.7–4kHz
Stim Level DPOAE: 40–70dB SPL; TEOAE: 83dB peSPL
Max Output 90dB SPL (safety limit)
Sampling Rate 31.25kHz
Mic Noise ≤-20dB SPL @2kHz; ≤-13dB SPL @1kHz (1Hz BW)
Test Time <10s/ear
Display Color LCD, 10×4 chars
Memory ≥250 tests
Dim/Weight 8.5×13×5cm; 180–234g
Power 3.6V Li-ion, 20hr operation
Ambient Noise Tolerates ≤70dB SPL
Standards IEC 60645-6, ANSI S3.36, CE 0124
五、使用方法（Usage Method）
中文
准备
开机：长按电源键，自动自检 + 校准。
选协议：DPOAE/TEOAE/ 联合，选测试耳。
选探头：成人用标准探头；新生儿 / 婴儿用软探头。
患者：清洁耳道（去耵聍），探头密封外耳道。
测试
按开始键 → 全自动采集、分析、判读。
屏幕实时显示波形、SNR、结果（PASS/REFER）。
单耳约 7~10 秒 完成。
数据与报告
自动保存；可查看、编辑、删除历史记录。
蓝牙 / USB 传输至 PC；选配打印机打印。
结束
长按电源键关机；清洁探头；充电存放。
English
Preparation
Power on: long-press → auto self-test + calibration.
Select protocol: DPOAE/TEOAE/combined, test ear.
Select probe: standard (adult) / soft (neonate/infant).
Patient: clean ear canal; probe seal.
Testing
Press Start → auto capture, analyze, interpret.
Display waveｆorm, SNR, PASS/REFER in real time.
Complete in 7–10s/ear.
Data & Reports
Auto-save; review, edit, delete history.
Bluetooth/USB to PC; print via optional printer.
Completion
Long-press to power off; clean probe; recharge for storage.
六、适应症（Indications）
中文
新生儿听力筛查：出生后 0~28 天，初筛 / 复筛。
婴幼儿 / 儿童筛查：0~6 岁，幼儿园 / 学校听力普查。
成人听力筛查：体检、职业噪声暴露、耳毒性药物监测。
听力损失诊断：耳蜗性（外毛细胞）损伤客观评估。
鉴别诊断：区分 传导性 / 耳蜗性 / 蜗后 听力损失。
术中 / 术后监测：人工耳蜗、中耳手术、耳毒性治疗监测。
特殊人群：婴幼儿、智障、昏迷、无法配合主观测听者。
English
Newborn Screening: Birth–28d, initial/rescreen gold standard.
Pediatric Screening: 0–6y, preschool/school hearing check.
Adult Screening: Physicals, occupational noise, ototoxic drug monitoring.
Hearing Loss Diagnosis: Objective assessment of cochlear (OHC) damage.
Differential Diagnosis: Classify conductive/cochlear/retrocochlear loss.
Intra/Post-Op Monitoring: CI, middle ear surgery, ototoxic treatment.
Special Populations: Infants, intellectually disabled, comatose, uncooperative.
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。
外耳道闭锁、严重狭窄、大量耵聍栓塞未清理。
探头接触区皮肤感染、破损、严重过敏。
环境噪声 ＞70dB SPL（结果无效）。
患者剧烈躁动、无法保持安静。
相对禁忌
鼓膜穿孔急性期（慎测，防感染）。
严重感冒、鼻塞（中耳负压，信号衰减）。
外耳道异物、水肿（影响密封）。
English
Absolute
Acute otitis externa, eczema, pain, active otorrhea.
Canal atresia, stenosis, impacted cerumen.
Skin infection/breakdown at probe site.
Ambient noise ＞70dB SPL (invalid results).
Uncontrollable restlessness/movement.
Relative
Acute TM perforation (infection risk).
Severe cold/congestion (middle ear artifact).
Foreign body, edema (poor seal).
八、注意事项（Precautions）
中文
操作：专业人员；探头必须完全密封，否则假阴性。
患者：测试前清理耳道；新生儿 / 婴儿需睡眠 / 安抚状态。
环境：尽量安静，远离手机、医疗设备电磁干扰。
校准：年度专业校准；开机自动校准，异常时重校。
清洁：探头 / 耳塞用 75% 酒精擦拭；严禁液体渗入主机。
电池：长期不用每月充一次；避免完全放电。
判读：结合声阻抗、ABR、耳镜综合诊断，不单一依赖 OAE。
安全：最大输出 90dB SPL，禁止超强度刺激。
English
Operation: Trained staff only; probe must seal completely to avoid false neg.
Patient: Clean canal; neonates/infants asleep/calm.
Environment: Quiet, avoid EMI (phones, medical devices).
Calibration: Annual professional cal; auto-cal on startup; recalibrate if abnormal.
Cleaning: 75% alcohol wipe; no liquid ingress.
Battery: Charge monthly in storage; avoid full discharge.
Interpretation: Correlate with immittance, ABR, otoscopy.
Safety: Max 90dB SPL; no overstimulation.
九、存储条件（Storage Conditions）
中文
温度：工作 4~38℃；存储 -20~+60℃。
湿度：15~90% RH（无冷凝）。
气压：500~1060hPa。
环境：干燥、通风、无尘；远离热源、潮湿、腐蚀、强电磁。
设备：清洁后放入便携包；探头 / 耳塞分离；电池保持 50% 电量。
English
Temperature: Operating 4–38℃; Storage -20–+60℃.
Humidity: 15–90%RH (non-condensing).
Pressure: 500–1060hPa.
Environment: Dry, ventilated, dust-free; away from heat, moisture, corrosion, EMI.
Equipment: Clean before storage; separate probe/tips; battery at 50% charge.
十、说明书核心信息（Manual Core）
中文
制造商：MAICO Diagnostic GmbH（德国）。
型号：Ero・Scan（基础版）、Ero・Scan Pro（诊断版）。
标准配置：主机、标准探头、新生儿软探头、多种耳塞、充电线、USB 线、便携包。
维护：年度校准；每月自检；探头 / 耳塞定期更换。
故障处理：无密封→换耳塞；无信号→查连接 / 校准；失真→检修。
保修：整机 2 年；配件 1 年；人为损坏 / 非授权维修除外。
安全：Class IIa 医疗设备；Type B 防电击；专业人员使用。
English
Manufacturer: MAICO Diagnostic GmbH (Germany).
Model: Ero•Scan (Basic), Ero•Scan Pro (Diagnostic).
Standard Package: Main unit, standard probe, neonatal soft probe, tips, charger, USB cable, case.
Maintenance: Annual calibration; monthly self-test; replace probes/tips regularly.
Troubleshooting: Poor seal→change tip; no signal→check connections/cal; distortion→service.
Warranty: 2-year system; 1-year accessories; exclude damage/unauthorized repair.
Safety: Class IIa, Type B; 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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