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上海康世达医疗器械有限公司 主营产品:医用体检,诊断,急救,化验,超声,医学分析,生命科学,消毒灭菌,康复治疗,手术室,急救室,诊疗室等设备,一类医疗器械,二类医疗器械,三类医疗器械,IVD及消毒器具耗材

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厂商直销国际听力听力测试平台Titan

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厂商直销国际听力听力测试平台Titan
桂经理19117326863微xin同号

管理类别

第二类

型号规格

Titan

结构及组成/主要组成成分

产品由主机、台座、电源适配器、探头、耳机(插入式耳机)、电极线、耳塞、校准腔及电池组成。

适用范围/预期用途

听力测试平台由四个模块组成:IMP440模块 声阻抗测试模块,用于进行中耳的声阻抗和声反射的测试,其中声阻抗还包括宽频声阻抗(WBT)测试,适用人群包括全部年龄段。ABRIS440模块 听觉脑干反应筛查模块,用于基于稳态技术的自动听性脑干反应的筛查测试。适用人群为新生儿。DPOAE440模块 畸变产物耳声发射测试模块,用于人耳的畸变产物耳声发射测试。适用人群包括全部年龄段。TEOAE440模块 瞬态诱发耳声发射测试模块,用于人耳的瞬态诱发耳声发射测试。适用人群包括全部年龄段。



一、工作原理(Working Principle)

中文

宽频声导抗(WBT/IMP440)原理通过探头发射 226Hz/678Hz/800Hz/1000Hz 探测音 及 226–8000Hz 宽频信号,改变外耳道气压(-400~+200daPa),测量中耳声阻抗、声顺、鼓室压、声反射阈 / 衰减 / 潜伏期,分析 中耳功能、咽鼓管功能、镫骨肌反射,识别中耳炎、耳硬化、听骨链病变。

耳声发射(OAE)原理

DPOAE(畸变产物):双频纯音(f1/f2)刺激耳蜗,记录 2f1–f2 畸变产物,评估外毛细胞功能。

TEOAE(瞬态诱发):短声 / 短纯音刺激,记录耳蜗瞬态反馈,判断耳蜗完整性。

峰压 OAE:中耳加压状态下测试,排除负压干扰,提升准确性。

听性脑干反应(ABRIS440)原理采用 CE-Chirp® 宽带刺激声(替代传统 Click),经电极记录耳蜗→听神经→脑干电位(I~V 波),自动分析阈值、潜伏期、波间期,客观评估听阈及蜗后病变,新生儿 / 不配合者适用。

智能降噪与自适应算法内置 Bayesian 加权平均、HiTrack 噪声抑制,过滤环境 / 体动干扰,非隔音室也可稳定测试。

English

Wideband Tympanometry (WBT/IMP440) PrincipleProbe delivers 226/678/800/1000Hz probe tones and 226–8000Hz wideband signals; varies ear canal pressure (-400~+200daPa); measures impedance, compliance, tympanometric peak pressure, acoustic reflex threshold/decay/latency; evaluates middle ear, Eustachian tube, stapedius reflex; identifies otitis media, otosclerosis, ossicular chain disorders.

Otoacoustic Emissions (OAE) Principle

DPOAE: Dual pure tones (f1/f2) stimulate cochlea; record 2f1–f2 distortion products to assess outer hair cell function.

TEOAE: Click/tone-pip stimuli; record transient cochlear responses to verify cochlear integrity.

Peak-Pressure OAE: Test under pressurized middle ear to eliminate negative pressure artifacts.

Auditory Brainstem Response (ABRIS440) PrincipleCE-Chirp® broadband stimulus (vs. traditional click); electrodes record cochlear→auditory nerve→brainstem potentials (waves I–V); auto-analyze threshold, latency, interwave intervals; objectively assess hearing thresholds and retrocochlear pathology; ideal for neonates/uncooperative patients.

Smart Noise Reduction & Adaptive AlgorithmsBayesian weighted averaging + HiTrack noise suppression filter ambient/body motion artifacts; stable testing in non-soundproof rooms.

二、产品功能(Product Functions)

中文

1. 中耳分析(IMP440/WBT440)

标准 / 宽频鼓室图(226~8000Hz)、3D 鼓室图

同 / 对侧声反射(阈、衰减、潜伏期)

咽鼓管功能(ETF1/2/3:鼓膜完整 / 穿孔 / 异常开放)

声能反射 / 吸收 / 透射 / 群延迟、等效耳道容积

2. 耳声发射(OAE440)

DPOAE:500~10000Hz、30~80dB SPL、自动判读

TEOAE:Click / 短纯音、0.5~5kHz、筛查 / 诊断模式

峰压 OAE、加压 OAE、噪声抑制

3. 听性诱发电位(ABRIS440)

AABR/ABR:CE-Chirp®、Click、Tone-pip、0.5~5kHz

ASSR(多频稳态):频率特异性听阈(500~4000Hz)

自动阈值、波分析、质量控制、快速筛查(3~5 分钟 / 耳)

4. 数据与传输

存储:1GB、>5 万次测试、患者档案管理

传输:USB、蓝牙、PC 软件(NOAH 兼容)

报告:自动生成、打印、PDF 导出

English

1. Middle Ear Analysis (IMP440/WBT440)

Standard/wideband tympanogram (226~8000Hz), 3D tympanogram

Ipsilateral/contralateral acoustic reflex (threshold, decay, latency)

Eustachian tube function (ETF1/2/3: intact/perforated/abnormally open TM)

Power reflectance/absorbance/transmittance/group delay, equivalent ear canal volume

2. Otoacoustic Emissions (OAE440)

DPOAE: 500~10000Hz, 30~80dB SPL, auto-interpretation

TEOAE: Click/tone-pip, 0.5~5kHz, screening/diagnostic modes

Peak-pressure OAE, pressurized OAE, artifact rejection

3. Auditory Evoked Potentials (ABRIS440)

AABR/ABR: CE-Chirp®, Click, Tone-pip, 0.5~5kHz

ASSR: Frequency-specific thresholds (500~4000Hz)

Auto-threshold, wave analysis, QC, rapid screening (3–5 min/ear)

4. Data & Connectivity

Memory: 1GB, >50,000 tests, patient database

Transfer: USB, Bluetooth, PC software (NOAH-compatible)

Reporting: Auto-generate, print, PDF export




三、产品特点(Product Features)

中文

模块化一体:IMP/OAE/ABR/ASSR 自由组合、按需升级

手持式便携:<380g、单手操作、彩色触屏、内置电池

超快速测试:CE-Chirp® 缩短 ABR 50%、一键自动、3~5 分钟 / 耳

宽频:WBT 226~8000Hz、3D 鼓室图、新生儿 / 婴儿高适配

全年龄段:新生儿(睡眠 / 镇静)、儿童、成人、特殊人群

抗干扰强:Bayesian 降噪、HiTrack、非隔音室可用

数据安全:大容量存储、无线传输、NOAH 兼容、合规追溯

临床权威:CE 0123、IEC 60645-5、ISO 8253-3、儿科

English

Modular Integration: IMP/OAE/ABR/ASSR configurable, field-upgradable

Handheld Portable: <380g, one-hand operation, color touchscreen, rechargeable battery

Ultra-Fast Testing: CE-Chirp® cuts ABR time by 50%, one-touch auto-test, 3–5 min/ear

Wideband Precision: WBT 226~8000Hz, 3D tympanogram, ideal for neonates/infants

All Ages: Neonates (sleep/sedated), children, adults, special populations

Artifact Resistant: Bayesian noise reduction, HiTrack, reliable in non-soundproof settings

Secure Data: Large memory, wireless transfer, NOAH-compliant, traceable

Clinical Gold Standard: CE 0123, IEC 60645-5, ISO 8253-3, pediatric preferred

四、技术参数(Technical Specifications)

中文

尺寸 / 重量:200×80×40mm;<380g(含电池)

显示:2.8 英寸彩色 LCD、触屏

电源:锂电池(连续 8 小时、待机 7 天)、USB 充电

中耳分析(IMP440)

探测音:226/678/800/1000Hz(85dB SPL)

宽频:226~8000Hz、压力 -400~+200daPa

声反射:500~4000Hz、70~115dB SPL、同侧 / 对侧

OAE(DPOAE/TEOAE)

DPOAE:500~10000Hz、30~80dB SPL、2f1–f2 检测

TEOAE:Click / 短纯音、0.5~5kHz、非线性采集

ABR/ASSR(ABRIS440)

刺激:CE-Chirp®、Click、Tone-pip、0.5~5kHz

灵敏度:≤25dB nHL(Click)、频率特异性 ±5dB

电极:一次性 / 重复、3 通道、阻抗监测

环境:工作 10~35℃、湿度 15~90%(无冷凝)

标准:IEC 60645-5、ISO 8253-3、CE 0123、Type B

English

Dimensions/Weight: 200×80×40mm; <380g (w/battery)

Display: 2.8" color LCD, touchscreen

Power: Li-ion (8h continuous, 7d standby), USB charging

Middle Ear (IMP440)

Probe tones: 226/678/800/1000Hz (85dB SPL)

Wideband: 226~8000Hz, pressure -400~+200daPa

Reflex: 500~4000Hz, 70~115dB SPL, ipsi/contra

OAE (DPOAE/TEOAE)

DPOAE: 500~10000Hz, 30~80dB SPL, 2f1–f2 detection

TEOAE: Click/tone-pip, 0.5~5kHz, nonlinear acquisition

ABR/ASSR (ABRIS440)

Stimuli: CE-Chirp®, Click, Tone-pip, 0.5~5kHz

Sensitivity: ≤25dB nHL (Click), freq-specific ±5dB

Electrodes: Disposable/reusable, 3-channel, impedance check

Environment: Operating 10–35℃, 15–90%RH (non-condensing)

Standards: IEC 60645-5, ISO 8253-3, CE 0123, Type B

五、使用方法(Usage Method)

中文

准备

开机自检、电量 / 校准确认、模块选择

患者:清洁耳道、安静 / 睡眠状态、电极 / 探头正确放置

环境:尽量安静(<50dB (A))、远离电磁干扰

中耳分析(WBT)

探头密封外耳道 → 自动气压扫描 → 记录鼓室图 / 声反射 → 自动判读

OAE 测试

探头密封 → 选择 DPOAE/TEOAE → 自动刺激 / 采集 → 噪声抑制 → 结果显示

ABR/ASSR 测试

电极贴(前额 + 乳突 + 接地)→ 阻抗检测 → CE-Chirp® 刺激 → 自动平均 → 阈值 / 波分析

数据管理

保存测试 → 蓝牙 / USB 传 PC → 生成报告 → 打印 / 导出

结束

关机、清洁探头 / 电极、充电、收纳

English

Preparation

Power on, self-test, battery/cal check, select module

Patient: Clean ear canal, quiet/sleep state, proper electrode/probe placement

Environment: Quiet (<50dB(A)), avoid EMI

Middle Ear Analysis (WBT)

Probe seal → auto pressure sweep → record tympanogram/reflex → auto-interpret

OAE Testing

Probe seal → select DPOAE/TEOAE → auto stimulation/recording → artifact rejection → results

ABR/ASSR Testing

Apply electrodes (forehead/mastoid/ground) → impedance check → CE-Chirp® stimulus → auto-averaging → threshold/wave analysis

Data Management

Save test → Bluetooth/USB transfer → generate report → print/export

Completion

Power off, clean probe/electrodes, charge, store

六、适应症(Indications)

中文

新生儿听力筛查:出生 0~28 天 AABR+OAE 初筛 / 复筛

婴幼儿诊断:0~3 岁不配合儿童客观听阈、中耳功能评估

中耳病变:中耳炎、耳硬化、听骨链中断、咽鼓管功能障碍

耳蜗病变:感音神经性聋、噪声性聋、耳毒性、梅尼埃病

蜗后病变:听神经瘤、脑干病变、面瘫、镫骨肌反射异常

特殊人群:智力障碍、自闭症、昏迷、镇静状态听力评估

术前 / 术后:人工耳蜗、中耳手术、听神经瘤术前诊断 / 术后监测

English

Neonatal Hearing Screening: 0–28d AABR+OAE initial/rescreen

Pediatric Diagnostic: 0–3y uncooperative children, objective thresholds, middle ear assessment

Middle Ear Disorders: Otitis media, otosclerosis, ossicular discontinuity, Eustachian tube dysfunction

Cochlear Disorders: Sensorineural hearing loss, noise-induced, ototoxicity, Meniere’s disease

Retrocochlear Disorders: Acoustic neuroma, brainstem lesions, facial palsy, abnormal reflexes

Special Populations: Intellectual disability, autism, coma, sedated patients

Pre/Post-Op: Cochlear implant, middle ear surgery, acoustic tumor diagnostics/monitoring

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、鼓膜穿孔急性期

电极 / 探头接触部位皮肤感染、破损、过敏

癫痫发作期、严重躁动、无法固定头部

相对禁忌

极度哭闹 / 体动剧烈(需睡眠 / 镇静后测试)

严重感冒 / 鼻塞(中耳负压,结果偏差)

环境噪声 >60dB (A)(干扰过大,结果无效)

English

Absolute Contraindications

Acute otitis externa/eczema, pain, active otorrhea

Canal atresia/stenosis, acute TM perforation

Skin infection, breakdown, allergy at electrode/probe site

Active epilepsy, severe agitation, unable to stabilize head

Relative Contraindications

Uncontrollable crying/movement (test after sleep/sedation)

Severe cold/congestion (middle ear artifact)

Ambient noise >60dB(A) (excessive interference, invalid results)

八、注意事项(Precautions)

中文

操作:专业人员培训;探头 / 电极正确放置;实时质量监控

患者:新生儿 / 婴儿睡眠状态;避免饥饿 / 困倦;安抚情绪

环境:尽量安静;远离手机 / WiFi / 医疗设备电磁干扰

校准:年度校准;每月自检;探头 / 电极定期更换

清洁:75% 酒精擦探头 / 外壳;禁液体渗入;一次性电极单人单用

电池:避免过充 / 过放;长期存储 50% 电量;每 3 个月充一次

解读:结合病史、耳镜、声导抗、OAE、ABR 综合判断

English

Operation: Trained personnel only; proper probe/electrode placement; real-time QC

Patient: Neonates/infants asleep; avoid hunger/fatigue; calm prior

Environment: Minimize noise; avoid EMI from phones/WiFi/medical devices

Calibration: Annual calibration; monthly self-test; replace probe/electrodes regularly

Cleaning: 75% alcohol wipe probe/case; no liquid ingress; single-use electrodes

Battery: Avoid overcharge/deep discharge; store at 50% charge; recharge q3 months

Interpretation: Correlate with history, otoscopy, IMP, OAE, ABR

九、存储条件(Storage Conditions)

中文

温度:工作 10~35℃;存储 -20~+60℃

湿度:15~90%(无冷凝)

气压:86~106kPa

环境:干燥、通风、无尘;远离热源、腐蚀、强电磁、尖锐物

设备:防尘袋 / 盒;探头 / 电极分离;电池 50% 电量;定期通电(每月 1 次)

English

Temperature: Operating 10–35℃; Storage -20–+60℃

Humidity: 15–90%RH (non-condensing)

Pressure: 86–106kPa

Environment: Dry, ventilated, dust-free; away from heat, corrosion, EMI, sharp objects

Equipment: Dust pouch/case; separate probe/electrodes; battery at 50% charge; power on monthly

十、说明书核心信息(Manual Core)

中文

制造商:Interacoustics A/S(丹麦);CE 0123;IEC 60645-5

型号:Titan 手持式听力测试平台(IMP440/OAE440/ABRIS440)

标准:IEC 60645-5、ISO 8253-3、EN 60601-1、ANSI S3.39

维护:年度校准;每月自检;探头寿命 1 年、电极 500 次更换

故障:无信号→查连接 / 校准;噪声→干扰 / 电极;失真→换探头

保修:整机 2 年;配件 1 年;人为损坏 / 非授权维修除外

安全:Type B 医疗设备;儿童安全;禁易燃环境;专业人员

English

Manufacturer: Interacoustics A/S (Denmark); CE 0123; IEC 60645-5

Model: Titan Handheld Hearing Test Platform (IMP440/OAE440/ABRIS440)

Standards: IEC 60645-5, ISO 8253-3, EN 60601-1, ANSI S3.39

Maintenance: Annual calibration; monthly self-test; probe (1y), electrodes (500 uses) replacement

Troubleshooting: No signal→check connections/cal; noise→artifact/electrodes; distortion→replace probe

Warranty: 2-year system; 1-year accessories; exclude damage/unauthorized repair

Safety: Class II medical device; child-safe; no flammable areas; 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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