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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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当前位置: 阿仪网 > 医疗器械 > 电子仪器 > 其他 > 上海康世达医疗器械有限公司 > 产品展示 > 听力设备 > 听力计 > 厂家直供尔听美Aud奥德听力计1081

厂家直供尔听美Aud奥德听力计1081

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品牌名称:$brandModel.Title型号: 原产地:中国大陆 医疗器械注册号(批文):国械注进20192072215更新时间:2026/10/16 11:11:02

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详细内容

厂家直供尔听美Aud奥德听力计1081
桂经理19117326863微xin同号

管理类别

第二类

型号规格

1081

结构及组成/主要组成成分

该产品由主机(内置HIPRO模块)、耳遂听(OTOsuite)测听软件以及以下标准配件构成。标准配件包括:ME⁻⁷0耳机、B⁻⁷1骨导振荡器、Freefit集成的Aurical扬声器设备、台式麦克风、患者应答器、电源适配器、干线电缆、壁挂板、连接线。

适用范围/预期用途

产品适合听力专家和其他经过培训的医疗保健专业人员在诊断和临床应用中测试患者的听力。


一、工作原理 / Working Principle

中文通过主机内置的数字信号发生器,产生、纯净的纯音、言语及掩蔽噪声信号,经 ME⁻⁷0 气导耳机、B⁻⁷1 骨导振荡器或内置声场扬声器,将不同频率、强度的声信号传导至听觉系统。患者通过应答器反馈,设备自动记录听阈;信号经高精度 AD/DA 转换、滤波与放大,配合 OTOsuite 软件分析,生成听力图与诊断数据。

EnglishGenerates precise pure-tone, speech and masking noise signals via built-in digital signal generator. Transmits acoustic signals at various frequencies and intensities through ME⁻⁷0 air-conduction earphones, B⁻⁷1 bone vibrator or integrated sound-field speakers to the auditory system. Patient responses are recorded via a response button; signals undergo high-precision AD/DA conversion, filtering and amplification, analyzed with OTOsuite software to generate audiograms and diagnostic data.

二、产品功能 / Functions

中文

纯音测听:气导、骨导、高频(至 12.5kHz)听阈测试

言语测听:内置中文 / 英文词表、句表,SRT、SDS 测试

特殊测试:SAL、TEN(选配)、QuickSIN(选配)噪声下言语测试

掩蔽助理:自动计算、推荐掩蔽强度,简化操作

声场测听:内置功放,支持助听器 / 人工耳蜗助听评估

数据管理:一键保存、兼容 Noah / 电子、多报告模板

助听器编程:内置 HI-PRO 模块(选配),直连编程

自定义流程:多组预设测试,一键调用

English

Pure-tone audiometry: Air conduction, bone conduction, high-frequency (up to 12.5kHz) threshold testing

Speech audiometry: Built-in Chinese/English word/sentence lists, SRT & SDS testing

Special tests: SAL, TEN (optional), QuickSIN (optional) speech-in-noise testing

Masking assistant: Automatic masking level calculation & recommendation

Sound-field testing: Built-in amplifier for hearing aid/cochlear implant evaluation

Data management: One-click save, Noah/EMR compatible, multiple report templates

Hearing aid programming: Built-in HI-PRO module (optional) for direct fitting

Custom protocols: Multiple preset tests, one-key recall




三、产品特点 / Features

中文

I 型高精度:频率 ±1%,强度 0.1dB 步进,失真 < 2%

超宽频:气导 125Hz–12.5kHz,覆盖早期噪声性聋检测

强输出:气导 - 10~120dB HL,适配极重度聋评估

集成化:听力计 + 功放 + HI-PRO + 言语库 + 声场一体机

便携紧凑:可桌面 / 壁挂 / 桌底安装,轻量化设计

智能软件:OTOsuite 中文界面,掩蔽自动计算

高兼容:USB、TCP/IP,对接医院信息系统

临床全流程:筛查→诊断→助听评估→报告一站式

English

Type I high precision: Frequency ±1%, 0.1dB intensity step, distortion <2%

Ultra-wide frequency: 125Hz–12.5kHz AC, detects early noise-induced loss

High output: -10~120dB HL AC, for severe-profound loss evaluation

All-in-one: Audiometer + amplifier + HI-PRO + speech library + sound field

Compact & portable: Desktop/wall/under-desk mount, lightweight

Intuitive software: Chinese OTOsuite, automatic masking calculation

High compatibility: USB, TCP/IP, connects to hospital IT systems

Full clinical workflow: Screening→diagnosis→aid evaluation→report

四、技术参数 / Technical Specifications

表格

项目 中文 English

类型 临床诊断型(I 级)听力计 Type I clinical diagnostic audiometer

通道 双独立通道 Dual independent channels

频率范围 气导:125Hz–12.5kHz

骨导:250Hz–8kHz AC: 125Hz–12.5kHz

BC: 250Hz–8kHz

强度范围 气导:-10~120dB HL

骨导:-10~90dB HL AC: -10~120dB HL

BC: -10~90dB HL

频率精度 ±1% ±1%

强度步进 0.1/1/2/5dB 0.1/1/2/5dB

失真度 耳机 < 2%,骨导 < 5% Earphones <2%, bone vibrator <5%

换能器 ME⁻⁷0 气导,B⁻⁷1 骨导,内置扬声器 ME⁻⁷0 AC, B⁻⁷1 BC, integrated speakers

掩蔽 白噪 / 粉噪 / 言语噪,自动掩蔽助理 White/pink/speech noise, auto masking assistant

言语测试 中文 / 英文词表、句表、SAL、QuickSIN CN/EN word lists, sentences, SAL, QuickSIN

接口 USB、HI-PRO(选配)、RJ45、音频 I/O USB, HI-PRO (optional), RJ45, audio I/O

供电 AC 100–240V,50/60Hz AC 100–240V, 50/60Hz

尺寸 / 重量 约 30×25×8cm,约 1.8kg Approx. 30×25×8cm, ~1.8kg

软件 OTOsuite 耳遂听,兼容 Noah OTOsuite software, Noah compatible

五、使用方法 / Operating Instructions

中文

安装:桌面 / 壁挂 / 桌底固定;连接耳机、骨导、应答器、电源、电脑

开机校准:启动 OTOsuite,每日校准换能器与声强

患者准备:清洁耳道,说明测试流程,佩戴耳机 / 骨振器

测试选择:纯音 / 言语 / 声场;调用预设流程

气导测试:125Hz–8kHz/12.5kHz,双耳分别测听阈

骨导测试:必要时加掩蔽,区分传导 / 感音性聋

言语测试:选词表 / 句表,测 SRT、言语识别率

数据保存:一键存档,导出听力图 / 报告

关机清洁:关闭软件与主机,消毒耳机与配件

English

Installation: Desktop/wall/under-desk mount; connect earphones, bone vibrator, response button, power, PC

Calibration: Launch OTOsuite, daily transducer & intensity calibration

Patient prep: Clean ear canals, instruct procedure, fit earphones/bone vibrator

Test selection: Pure-tone/speech/sound field; recall preset protocols

AC testing: 125Hz–8kHz/12.5kHz, binaural threshold testing

BC testing: Apply masking if needed, differentiate conductive/sensorineural loss

Speech testing: Select word/sentence lists, measure SRT & speech discrimination

Save data: One-click archive, export audiogram/report

Shutdown & clean: Close software & unit, disinfect earphones & accessories

六、适应症 / Indications

中文

听力损失诊断:传导性、感音神经性、混合性聋

人群筛查:成人、儿童、新生儿(配合 ABR)

病因鉴别:中耳炎、耳硬化、噪声性、老年性、药物性聋

中枢评估:中枢听觉处理障碍(CAPD)

助听评估:助听器 / 人工耳蜗术前评估、术后效果验证

职业病鉴定:噪声作业听力损伤诊断

眩晕 / 耳鸣:梅尼埃病、听神经瘤辅助诊断

English

Hearing loss diagnosis: Conductive, sensorineural, mixed hearing loss

Population screening: Adults, children, neonates (with ABR)

Etiology differentiation: Otitis media, otosclerosis, noise-induced, presbycusis, ototoxic loss

Central assessment: Central auditory processing disorders (CAPD)

Aid evaluation: Pre-op assessment & post-op verification for hearing aids/cochlear implants

Occupational disease: Noise-induced hearing loss diagnosis

Vertigo/tinnitus: Auxiliary diagnosis of Meniere’s disease, acoustic neuroma

七、禁忌症 / Contraindications

中文

无绝对禁忌症,以下情况慎用 / 注意:

外耳道急性炎症、破损、出血(暂缓测试)

鼓膜穿孔、中耳炎急性期(骨导优先)

严重眩晕、恶心呕吐(待稳定后测试)

头部 / 耳部外伤急性期(避免压迫)

对耳机材质过敏(更换护套 / 消毒)

无法配合者(儿童 / 意识障碍:客观测试 ABR)

English

No absolute contraindications; caution in:

Acute otitis externa, wounds, bleeding (postpone testing)

Perforated eardrum, acute otitis media (prioritize bone conduction)

Severe vertigo, nausea/vomiting (test after stabilization)

Acute head/ear trauma (avoid pressure)

Allergy to earphone materials (change cushions/disinfect)

Uncooperative patients (children/impaired consciousness: use ABR)

八、注意事项 / Precautions

中文

环境:测听室噪声 <30dB (A),电磁屏蔽良好

校准:每日开机自检,定期年度计量校准

患者:测试前 24h 禁噪声暴露、酒精、镇静剂

操作:严格按 10-20dB 降频、5dB 升频法则

掩蔽:气骨导差 > 10dB 及时掩蔽,防交叉听力

设备:防摔、防水、防尘;耳机轻拿轻放

消毒:耳机罩 75% 酒精擦拭,骨导头清洁

人员:持证操作,熟悉临床测听规范

数据:及时备份,防止丢失

English

Environment: Booth noise <30dB(A), good EMI shielding

Calibration: Daily self-test, annual metrological calibration

Patient: No noise exposure, alcohol, sedatives 24h prior

Operation: Follow 10-20dB down, 5dB up rule

Masking: Apply masking when AC-BC gap >10dB to prevent cross-hearing

Equipment: Shockproof, waterproof, dustproof; handle earphones gently

Disinfection: Ear cushions with 75% alcohol, clean bone vibrator

Personnel: Licensed operation, comply with clinical standards

Data: Timely backup to prevent loss

九、存储条件 / Storage Conditions

中文

温度:-10℃~+50℃

湿度:20%~80%(非冷凝)

气压:860~1060hPa

环境:干燥、通风、无尘、无腐蚀性气体

避免:阳光直射、高温、潮湿、强磁场、震动

配件:耳机、骨导盒装置于干燥盒,防老化

长期存储:每 3 个月通电一次,激活电子元件

English

Temperature: -10°C to +50°C

Humidity: 20%–80% (non-condensing)

Atmospheric pressure: 860–1060hPa

Environment: Dry, ventilated, dust-free, non-corrosive gas

Avoid: Direct sunlight, high temperature, humidity, strong magnetic field, shock

Accessories: Store earphones & bone vibrator in dry box to prevent aging

Long-term storage: Power on once every 3 months to activate electronics

十、说明书核心信息(中英文) / Manual Core Info

中文核心

名称:尔听美奥德 1081 听力计(Aud 1081)

注册证:国械注进 2019207XXXX(二类)

组成:主机、ME⁻⁷0 耳机、B⁻⁷1 骨导、应答器、电源、OTOsuite 软件

标准:IEC 60601-1、IEC 60645-1/2(I 级听力计)

用途:临床听力诊断、筛查、助听评估

安全:BF 型应用部分,防电击保护

维护:年度校准、日常清洁、软件更新

保修:原厂 1 年保修,授权维修

English Core

Name: Otometrics Aud 1081 Audiometer

Certification: China NMPA Class II, CE

Components: Main unit, ME⁻⁷0 earphones, B⁻⁷1 bone vibrator, response button, power supply, OTOsuite

Standards: IEC 60601-1, IEC 60645-1/2 (Type I)

Intended use: Clinical audiometric diagnosis, screening, hearing aid evaluation

Safety: Type BF applied part, electric shock protection

Maintenance: Annual calibration, daily cleaning, software updates

Warranty: 1-year manufacturer warranty, authorized service


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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