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厂商直销尔听美听力筛查仪Type1077(AccuScreen DP)
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厂商直销尔听美听力筛查仪Type1077(AccuScreen DP)
桂经理19117326863微xin同号
管理类别
第二类
型号规格
Type 1077(AccuScreen TE), Type 1077(AccuScreen DP), Type 1077(AccuScreen TE/DP),Type 1077(AccuScreen ABR), Type 1077(AccuScreen ABR/DP), Type 1077(AccuScreen ABR/TE),Type 1077(AccuScreen ABR/TE/DP), Type 1077(AccuScreen Lite TE)
结构及组成/主要组成成分
见附页。
适用范围/预期用途
该产品是用于听力筛查损失的便携式仪器。本产品采用畸变产物诱发耳声发射(DPOAE)，瞬态诱发耳声发射(TEOAE)和自动听性脑干反应(AABR)技术进行听力筛查。
一、工作原理 (Working Principle)
中文采用耳声发射（OAE）与自动听性脑干反应（AABR）双模技术：
TEOAE（瞬态诱发耳声发射）：通过探头发出短声刺激，检测耳蜗外毛细胞受激后产生的 “回声” 信号，评估外周听力（耳蜗）功能。
DPOAE（畸变产物耳声发射）：双频纯音刺激，检测耳蜗非线性畸变产物信号，评估特定频率听力敏感性。
AABR（自动听性脑干反应）：声刺激诱发脑干电信号，通过头皮电极记录并叠加平均，评估听神经至脑干传导通路功能。设备自动信号处理、噪声抑制、智能判读，给出PASS/REFER结果。
EnglishAdoptsdual-mode OAE + AABR technology:
TEOAE (Transient Evoked Otoacoustic Emissions): Emits click stimuli, detects "echo" signals from cochlear outer hair cells to assess peripheral (cochlear) hearing function.
DPOAE (Distortion Product Otoacoustic Emissions): Dual-tone stimulation, detects nonlinear distortion products to evaluate frequency-specific sensitivity.
AABR (Automated Auditory Brainstem Response): Acoustic stimuli evoke brainstem electrical potentials, recorded via scalp electrodes and averaged to assess auditory nerve-brainstem pathway function.Automatic signal processing, noise rejection, and intelligent analysis yieldPASS/REFERresults.
二、功能 (Functions)
中文
TEOAE 筛查：瞬态声诱发，1.5–4.5kHz，70–84dB SPL，快速外周听力评估。
DPOAE 筛查：2/3/4/5kHz，60/50 或 65/55dB SPL，频率特异性检测。
AABR 筛查：30–45dB nHL Chirp 刺激，双耳同步，脑干通路筛查。
三模组合：TEOAE/DPOAE/AABR 独立或组合使用，提升准确率。
智能判读：自动噪声加权、模板匹配、波形分析、PASS/REFER 输出。
数据管理：存储≥500 例结果，USB 上传电脑，中文报告生成。
自检校准：探头 / 电极阻抗自检，内置校准腔，确保。
English
TEOAE Screening: Click-evoked, 1.5–4.5kHz, 70–84dB SPL, rapid peripheral assessment.
DPOAE Screening: 2/3/4/5kHz, 60/50 or 65/55dB SPL, frequency-specific testing.
AABR Screening: 30–45dB nHL Chirp, binaural simultaneous, brainstem pathway testing.
Tri-Mode Combo: TEOAE/DPOAE/AABR standalone or combined for higher accuracy.
Smart Analysis: Auto noise-weighting, template matching, waveｆorm analysis, PASS/REFER output.
Data Management: Stores ≥500 results, USB upload, Chinese report generation.
Self-Calibration: Probe/electrode impedance self-test, built-in calibration cavity.
三、产品特点 (Product Features)
中文
三模一体：TEOAE+DPOAE+AABR 全覆盖，新生儿 / 婴幼儿准。
便携轻巧：主机 280g，手持设计，锂电池续航 8 小时。
触控操作：2.8 寸彩色 TFT 触摸屏，全中文界面，手套可操作。
快速筛查：单耳≤1 分钟，自动判读，无需专业经验。
抗干扰强：智能降噪，环境噪声耐受度高，适合病房 / 门诊。
安全设计：一次性耳塞 / 电极，BF 型隔离，无交叉感染。
数据安全：用户登录，时钟标记，可追溯管理。
English
Tri-Mode Integration: TEOAE+DPOAE+AABR, gold-standard for infants.
Ultra-Portable: 280g handheld, 8hr Li-ion battery.
Touch Control: 2.8" color TFT touchscreen, Chinese UI, glove-operable.
Rapid Testing: ≤1min/ear, auto-interpretation, minimal training.
High Noise Immunity: Smart noise reduction, ideal for ward/clinic.
Safe Design: Disposable tips/electrodes, Type BF isolation.
Data Security: User log, time-stamp, traceable records.
四、技术参数 (Technical Specifications)
中文
筛查模式：TEOAE、DPOAE、AABR（三模）
TEOAE：刺激 Click，70–84dB SPL，1.5–4.5kHz，速率≈60Hz
DPOAE：f2/f1=1.24，f2=1–6kHz，L1/L2=60/50 或 65/55dB SPL
AABR：Chirp 刺激，30/35/40/45dB nHL，双耳同步，速率≈80Hz
显示屏：2.8 寸彩色 TFT 触摸屏，240×320 像素
存储：≥500 个测试结果，USB 传输
电池：锂电池，连续 8 小时，底座充电
尺寸 / 重量：200×73×34mm，280g
注册证：国械注进 20172072457，II 类医疗器械
English
Modes: TEOAE, DPOAE, AABR (tri-mode)
TEOAE: Click stimulus, 70–84dB SPL, 1.5–4.5kHz, ~60Hz rate
DPOAE: f2/f1=1.24, f2=1–6kHz, L1/L2=60/50 or 65/55dB SPL
AABR: Chirp, 30/35/40/45dB nHL, binaural simultaneous, ~80Hz
Display: 2.8" color TFT touchscreen, 240×320 pixels
Memory: ≥500 results, USB transfer
Battery: Li-ion, 8hr continuous, dock charging
Dim/Weight: 200×73×34mm, 280g
Registration: CFDA 20172072457, Class II
五、使用方法 (Usage)
中文
准备：开机自检；选筛查模式（TEOAE/DPOAE/AABR）；装一次性耳塞。
患者准备：婴儿安睡 / 安静；清洁耳道；OAE 探头密封外耳道；AABR 贴电极（前额 + 乳突）。
测试：点击开始；自动刺激、采集、判读；单耳完成后换侧。
结果：显示 PASS/REFER；查看波形、噪声水平、DP-Gram。
数据：存储结果；USB 上传至电脑；打印报告。
收尾：弃耳塞；清洁探头；关机；底座充电。
English
Prep: Power-on self-test; select mode (TEOAE/DPOAE/AABR); fit disposable tip.
Patient: Infant asleep/quiet; clear ear canal; seal probe (OAE); apply electrodes (AABR).
Test: Start; auto stimulation, acquisition, analysis; switch ears.
Result: Display PASS/REFER; view waveｆorm, noise, DP-Gram.
Data: Save results; USB upload; print report.
Finish: Discard tip; clean probe; power off; charge in dock.
六、适应症 (Indications)
中文
新生儿听力筛查：34 周胎龄至 6 个月健康婴儿出院前常规筛查。
婴幼儿听力评估：0–3 岁无法行为测听者的听力损失初筛。
高危儿筛查：早产、黄疸、窒息、耳聋家族史等高风险婴儿。
儿童体检：幼儿园 / 学龄前儿童听力普查。
特殊人群：智力障碍、自闭症、老年痴呆等无法配合者。
English
Newborn Screening: Routine for infants 34 weeks–6 months before discharge.
Pediatric Assessment: Initial screening for 0–3yrs unable to do behavioral testing.
High-Risk Infants: Prematurity, jaundice, asphyxia, family history of deafness.
Childhood Screening: Preschool/pediatric population screening.
Special Populations: Intellectual disability, autism, dementia, uncooperative patients.
七、禁忌症 (Contraindications)
中文
绝对禁忌：外耳道急性感染、鼓膜穿孔、耳道闭锁 / 畸形。
头部皮肤破损、感染、电极过敏（AABR）。
婴儿躁动、哭闹无法镇静，严重颅面部畸形。
相对禁忌：中耳积液、耵聍栓塞（需清理后测试）。
English
Absolute: Acute otitis externa, tympanic perforation, ear atresia.
Scalp lesion/infection, electrode allergy (AABR).
Uncontrollable crying, severe craniofacial malｆormation.
Relative: Middle ear effusion, impacted cerumen (clear before test).
八、注意事项 (Precautions)
中文
环境：保持安静（≤50dB）；远离电磁干扰（手机、监护仪）。
患者：婴儿需自然睡眠，禁用镇静剂；清洁耳道无耵聍。
操作：探头密封良好；AABR 电极阻抗 < 12kΩ。
感染控制：一次性耳塞 / 电极一人一用；探头酒精消毒。
结果：REFER 需 48 小时复筛；仍未过转诊断性 AABR / 声导抗。
设备：每日校准；定期更换探头膜；电池满电存放。
English
Environment: Quiet (≤50dB); isolate from EMI (phones, monitors).
Patient: Natural sleep only; no sedation; clear ear canal.
Operation: Good probe seal; AABR electrode impedance <12kΩ.
Infection Control: Single-use tips/electrodes; probe disinfection.
Results: REFER → rescreen in 48hrs; failure → diagnostic AABR/tympanometry.
Equipment: Daily calibration; replace probe membrane; store fully charged.
九、存储条件 (Storage Conditions)
中文
环境：温度 10–35℃；湿度 30%–70%（无凝露）；无尘、无腐蚀气体。
设备存放：主机置于充电底座；探头套保护；线缆松弛盘绕。
耗材：耳塞 / 电极阴凉干燥（<25℃）；有效期内使用。
长期存储：每 3 个月充电 1 次；开机自检；校准验证。
运输：防震包装；温度 0–40℃；避免挤压、摔落。
English
Environment: 10–35°C, 30–70% RH (non-condensing), dust-free, non-corrosive.
Storage: Main unit in charging dock; probe covered; loose cables.
Consumables: Cool/dry (<25°C); use before expiry.
Long-Term: Charge every 3 months; self-test; verify calibration.
Transport: Shock-proof packaging; 0–40°C; avoid compression/drops.
十、说明书核心信息 (Manual Core Inｆormation)
中文
注册信息：Natus Otometrics AccuScreen Type 1077；国械注进 20172072457；II 类。
系统组成：主机、OAE 探头、AABR 电极线、一次性耳塞、充电底座、USB 线、软件。
维护：每日清洁消毒；每周探头校准；年度性能验证。
故障处理：
无信号→查探头密封、耳塞、耳道、阻抗
噪声过高→环境降噪、重新放置探头
无法充电→清洁底座触点、更换电池
保修：整机 1 年；探头 / 线缆 6 个月；耗材不在保修。
合规：IEC 60601-1、IEC 60601-2-16；EN 55011 电磁兼容。
English
Registration: Natus Otometrics AccuScreen Type 1077; CFDA 20172072457; Class II.
Components: Main unit, OAE probe, AABR cable, tips, charging dock, USB, software.
Maintenance: Daily cleaning; weekly probe calibration; annual verification.
Troubleshooting:
No signal → check seal, tip, ear canal, impedance
High noise → quiet environment, reposition probe
No charge → clean contacts, replace battery
Warranty: 1-year unit; 6-month probe/cable; consumables excluded.
Compliance: IEC 60601-1, IEC 60601-2-16; EN 55011 EMC.
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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